UNITED STATES OF AMERICA 

BEFORE THE FEDERAL TRADE COMMISSION 

OFFICE OF THE ADMINISTRATIVE LAW JUDGES 

Washington, D.C. 

In the Matter of 

ECM BioFilms, Inc., 

a corporation, also d/b/a 

Enviroplastics International, 

Respondent. 

 

Docket No. 9358 

PUBLIC 

 

RESPONDENT ECM BIOFILMS’ PROPOSED FINDINGS OF FACT AND 

CONCLUSIONS OF LAW 

Jonathan W. Emord, Esq. 

Emord & Associates, P.C. 

11808 Wolf Rune Lane 

Clifton, VA 20124 

Ph: 202-466-6937 

Fx: 202-466-6938 

Em: jemord@emord.com 

Peter A. Arhangelsky, Esq. 

Eric J. Awerbuch, Esq. 

Bethany R. Kennedy, Esq. 

Joshua Furman 

Emord & Associates, P.C. 

3210 S. Gilbert Road, Ste 4 

Chandler, AZ 85286 

Ph: 202-466-6937 

Fx: 602-393-4361 

Em: parhangelsky@emord.com, eawerbuch@emord.com, 

 bkennedy@emord.com 
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TABLE OF CONTENTS 

I. SUMMARY OF COMPLAINT, ANSWER AND PROCEDURAL 

BACKGROUND ............................................................................................................... 1 

A. FTC’s Complaint ............................................................................................................ 1 

B. ECM’s Answer ............................................................................................................... 2 

C. Procedural Background .................................................................................................. 3 

D. Evidence Before This Court ........................................................................................... 4 

II. BACKGROUND OF ECM BIOFILMS, INC. .................................................................. 5 

III. WITNESSES...................................................................................................................... 7 

A. ECM’s Fact Witnesses ................................................................................................... 7 

1. Robert Sinclair ............................................................................................................ 7 

2. Kenneth Sullivan ........................................................................................................ 8 

3. Timothy Barber........................................................................................................... 9 

4. Thomas Poth ............................................................................................................. 10 

5. Alan Johnson ............................................................................................................ 12 

B. ECM’s Expert Witnesses ............................................................................................. 13 

1. Dr. Ranajit Sahu ....................................................................................................... 13 

2. Dr. Morton Barlaz..................................................................................................... 16 

3. Dr. Ryan Burnette ..................................................................................................... 17 

4. Dr. David Stewart ..................................................................................................... 19 

C. Complaint Counsel’s Fact Witnesses ........................................................................... 22 

D. Complaint Counsel’s Expert Witnesses ....................................................................... 22 
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1. Thabet Tolaymat ....................................................................................................... 22 

2. Stephen McCarthy .................................................................................................... 23 

3. Shane Frederick ........................................................................................................ 24 

4. Frederick Michel....................................................................................................... 25 

IV. ECM’S CUSTOMERS .................................................................................................... 26 

A. ECM’s Customers Are All Sophisticated Plastic Manufacturers That Do 

Not Base Their Purchasing Decisions Of The ECM Additive On Any Rate 

Claim—Whether Implied Or Explicit—Made By ECM .............................................. 26 

B. Deposition Testimony Confirms that ECM’s Customers are Sophisticated 

Plastic Manufacturers ................................................................................................... 38 

C. Deposition Testimony Confirms that the Rate of Biodegradation of Plastic 

Containing the ECM Additive is not Material to any of ECM’s Customers’ 

Purchasing Decisions ................................................................................................... 49 

D. Deposition Testimony Does Not Help Complaint Counsel Meet Its Burden 

of Proof ......................................................................................................................... 59 

V. BACKGROUND ON THE ECM ADDITIVE AND PLASTICS PRODUCED 

WITH THE ECM ADDITIVE ......................................................................................... 60 

VI. WHY BIODEGRADATION OF PLASTIC CONTAINING THE ECM 

ADDITIVE MAY NOT OCCUR .................................................................................... 61 

VII. CONTRARY TO COMPLAINT COUNSEL’S EXTREMELY NARROW 

DEFINITION, THE ONLY SCIENTIFICALLY ACCEPTED DEFINITION 

OF “BIODEGRADABLE” IS BROAD .......................................................................... 62 

VIII. THE GREEN GUIDES’ DEFINITION OF BIODEGRADABLE IS 

INAPPOSITE IN THIS CASE ........................................................................................ 67 

A. Both Dr. Stewart And Dr. Frederick Agree That The APCO and Synovate 

Surveys Are Flawed And Insufficient To Support The One Year Rule ....................... 67 

B. Complaint Counsel’s Survey Is Incompetent and Unreliable, and Should be 

Disregarded .................................................................................................................. 73 
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IX. COMPLAINT COUNSEL HAS NOT DEMONSTRATED THAT THE 

RATE OF BIODEGRADATION IN LANDFILLS IS MATERIAL TO 

CONSUMER PURCHASING DECISIONS ................................................................... 90 

X. ECM ACCURATELY DEFINED “BIODEGRADABILITY” IN ITS 

MATERIALS GIVEN TO CONSUMERS ................................................................... 109 

XI. DR. MCCARTHY IS BIASED, INCONSISTENT, AND NOT CREDIBLE .............. 110 

XII. COMPLAINT COUNSEL HAS NOT SHOWN THAT ECM’S 

BIODEGRADABILITY CLAIM IS FALSE ................................................................ 129 

A. Complaint Counsel Provided No Evidence Concerning What Competent 

and Reliable Scientific Evidence Can Show the Rate that a Product will 

Biodegrade in a Landfill ............................................................................................. 129 

B. Experts Agree that Gas Evolution Tests Are Competent and Reliable 

Evidence to Prove that a Product is “Biodegradable” ................................................ 131 

XIII. DR. RANAJIT SAHU’S TESTIMONY ........................................................................ 133 

A. Dr. Sahu Testified that Plastic Containing the ECM Additive is 

Biodegradable ............................................................................................................. 133

B. Dr. Sahu Testified to the Manufacturing Process of Plastic Containing the 

ECM Additive ............................................................................................................ 137 

C. Dr. Sahu Testified that Many Factors Can Affect the Biodegradable Feature 

of Plastic Containing the ECM Additive .................................................................... 139 

XIV. GAS EVOLUTION TESTS ARE COMPETENT AND RELIABLE 

EVIDENCE, AND RADIOLABELED TESTING IS NOT REQUIRED .................... 144 

XV. DR. MORTON BARLAZ’S TESTIMONY .................................................................. 147 

A. Dr. Barlaz Testified that Biodegradation Occurs in MSW Landfills ......................... 147 

B. Dr. Barlaz Testified that Gas Evolution Tests are Competent and Reliable to 

Prove Biodegradability ............................................................................................... 154 

C. Dr. Barlaz Testified that Complaint Counsel’s Theory on In Situ and 

Lysimeter Studies is Not Supported ........................................................................... 156 
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D. Dr. Barlaz Testified that Complaint Counsel’s Reliance on Carbon-14 

Testing Is Unsupported .............................................................................................. 158 

E. Dr. Barlaz Testified that Gas Evolution Data from ECM Biodegradation 

Testing Proves that Plastic Containing the ECM additive are Biodegradable ........... 159 

F. Dr. Barlaz Testified that the Plateau and Priming Effects are Not Bases to 

Reject ECM Testing ................................................................................................... 163 

1. The Plateau Effect .................................................................................................. 163 

2. The Priming Effect ................................................................................................. 164 

XVI. DR. RYAN BURNETTE TESTIFIED TO THE KINDS, NATURE, AND 

FUNCTIONS OF MICROBES THAT BIODEGRADE PLASTICS ........................... 166 

XVII. TESTING PROVES THAT PLASTIC CONTAINING THE ECM 

ADDITIVE IS BIODEGRADABLE ............................................................................. 173 

A. Aerobic Testing .......................................................................................................... 173 

1. RX 465, 2009 SSCCP Aerobic Test ....................................................................... 174 

2. RX 467, 2012 SSCCP Aerobic Test ....................................................................... 175 

3. RX 468, 2012 SSCCP Aerobic Test ....................................................................... 175 

4. RX 273, 2010 Ecologia Applicata Aerobic Test .................................................... 175 

5. RX 276, 2011 Ecologia Applicata Aerobic Test .................................................... 176 

6. RX 263, 1998 OWS Aerobic Test .......................................................................... 177 

7. RX 266, 2000 OWS Aerobic Test .......................................................................... 177 

B. Anaerobic Testing ...................................................................................................... 177 

1. Eden Laboratories (“ERL”) Testing Generally ...................................................... 177 

a. RX 248, Eden Laboratories No. 092511B .......................................................... 180 

b. RX 839, Eden Laboratories No. 070312C .......................................................... 182 

c. RX 403, Eden Laboratories Fellows Test ........................................................... 183 
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d. RX 402, Eden Laboratories FP International Testing ......................................... 185 

e. CCX-548, Eden Laboratories FP International Testing ...................................... 186 

f. CCX 546, Eden Laboratories FP International Testing ...................................... 188 

g. CCX 534, Eden Laboratories MicroTek Testing ................................................ 189 

h. CCX 547, Eden Laboratories EcoLab Testing ................................................... 191 

2. Northeast Laboratories Testing Generally .............................................................. 193 

a. RX 836, NE Labs N1048340 (PPC Industries, Inc.) Testing ............................. 198 

b. RX 838, NE Labs 1149980 (MINIGRIP) Testing .............................................. 200 

c. RX 398, NE Labs N0946510-01 (Masternet I) Testing ...................................... 202 

d. RX 405, NE Labs 1048742-01 (Eco SmartPlastics) Testing .............................. 204 

e. RX 396, NE Labs 1048819 (Eco SmartPlastics) Testing ................................... 204 

f. RX 395, NE Labs 1150851 (Sweet Tape Enterprise) Testing ............................ 206 

g. RX 394, NE Labs 1150851 (Tycoplas Sdn. Bhd.) Testing ................................. 206 

h. RX 393, NE Labs 1253020 (National Tree Co.) Testing ................................... 208 

i. RX 392, NE Labs 1048036 (Transilwrap Co.) Testing ...................................... 210 

j. RX 399, NE Labs N0843980 (Bio-Tec Environmental, LLC) Testing .............. 211 

3. Other Anaerobic Gas Evolution Testing ................................................................ 212 

a. CCX 952, NC State 2010 StarchTech BMP Testing .......................................... 212 

b. RX 265, OWS Microtech Research Inc. Anaerobic Testing (Feb 1999) ............ 213 

c. RX 268, OWS Covidien Anaerobic Testing (May 2010) ................................... 213 

4. Qualitative Testing ................................................................................................. 214 

XVIII. DR. TOLAYMAT’S OPINIONS ARE NOT CREDIBLE ............................................ 218 
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XIX. AN INCONCLUSIVE TEST IS NOT PROOF OF A NEGATIVE TEST ................... 232 

XX. THIS COURT SANCTIONED COMPLAINT COUNSEL FOR A 

DISCOVERY OBLIGATION ....................................................................................... 234 

XXI. DR. MICHEL, A LAST MINUTE SURPRISE REBUTTAL WITNESS, 

LACKED CREDIBILITY ............................................................................................. 234 

PROPOSED CONCLUSIONS OF LAW .............................................................................. 234 

 
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RESPONDENT ECM BIOFILMS’ PROPOSED FINDINGS OF FACT 

I. SUMMARY OF COMPLAINT, ANSWER AND PROCEDURAL BACKGROUND 

A. FTC’s Complaint 

1. The Federal Trade Commission (“FTC”) issued its Complaint against ECM BioFilms, 

Inc. (“Respondent” or “ECM”) on October 18, 2013. (See Comp.). 

2. The Complaint challenges ECM’s advertising of its plastics additive, MasterBatch 

Pellets (“ECM Additives”), the formula for which is a trade secret. (Comp. ¶ 2). 

3. The FTC alleges that Respondent disseminated or caused to be disseminated printed 

advertisements, website advertisements, certifications and other promotional 

materials to distributors, customers, and end-use consumers. (Comp. ¶ 4). 

4. The FTC alleges that these materials make false and/or misleading representations. 

(Comp. ¶ 11). 

5. Specifically, the FTC complains of four claims: 1) ECM Plastics are biodegradable; 

2) ECM Plastics are biodegradable in a landfill; 3) ECM Plastics biodegrade in a 

stated qualified timeframe (nine months to five years OR greater than one year); and 

4) ECM Plastics have been shown to be biodegradable, biodegradable in a landfill, or 

biodegradable in a stated qualified timeframe under various scientific tests, including, 

but not limited to, ASTM D5511. (Comp. ¶ 9). 

6. The FTC defines the term “biodegradable” to mean “will completely break down and 

decompose into elements found in nature within a reasonably short period of time 

after customary disposal.” (Comp. ¶ 9(A)). 

7. The FTC defines a “reasonably short period of time” to be “one year or less.” 

(Comp.¶¶ 4(A), 9(A)(i)). 

8. The FTC refutes the validity of all four alleged ECM claims. (Comp. ¶ 10). 

9. The FTC alleges that at the time ECM made the above representations, ECM did not 

possess and rely on a reasonable basis that substantiated the representations. (Comp. ¶ 

13). 

10. Complaint Counsel alleges that Respondent distributed promotional materials to its 

customers and independent distributors, and in so doing, provided them with the 

means and instrumentalities for the commission of deceptive acts or practices in 

violation of section 5(a) of the FTCA. (Comp. ¶ 14–15). 
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B. ECM’s Answer 

11. Respondent filed an answer on November 14, 2013. (See Answer). 

12. In its Answer, Respondent explains that the Complaint fails to state a claim upon 

which relief can be granted under Section 5 of the FTC Act, 15 U.S.C. § 45. (Answer 

at 11). 

13. Respondent states that the requested relief, if granted, would not be in the public 

interest. (Answer at 12). 

14. Respondent further states that any alleged deception of the end-use consumer is 

caused by third parties, i.e. downstream plastics manufacturers and suppliers who 

market directly to end-use consumers. (Answer at 11). 

15. Respondent states that it acted in good faith in all of its marketing practices and took 

affirmative steps to comply with apparent FTC advertising requirements after the 

FTC revised its Green Guides effective October 2012. (Answer at 12). 

16. Respondent also states that there is no danger of recurrence of any of the alleged 

violations and the requested relief is not reasonably related to ECM’s alleged 

violations. (Answer at 13). 

17. Respondent further states that the advertising claims excerpted by the FTC in its 

Complaint are not material to the purchasing decisions of ECM customers. (Answer 

at 13). 

18. Respondent states that the Complaint ordering paragraphs, if adopted, violate ECM’s 

First Amendment right to communicate truthful commercial speech, and as such, the 

FTC lacks authority to impose the requested relief. (Answer at 13). 

19. Respondent also states that the FTC’s allegations are predicated on arbitrary and 

capricious regulatory policies, particularly the One Year Rule, that are illogical, 

contrary to scientific evidence, and not based on substantial evidence. (Answer at 14). 

20. Respondent further states that the FTC violates the APA by arbitrarily and 

capriciously enforcing its 2012 revisions to the Green Guides to commercial speech 

that predated those same guides. (Answer at 15). 

21. Respondent states that the Commission violates ECM’s right to Due Process under 

the Fifth Amendment to the United States Constitution by abrogating the Separation 

of Functions Doctrine. (Answer at 15). 
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22. Respondent denies any allegation to the extent that it depends on the FTC’s definition 

of “biodegradable.” (See Answer). 

23. Respondent states that it has always qualified its claims to provide its customers 

accurate and non-misleading information concerning the nature and characteristics of 

the Plastic containing the ECM additive. (Answer ¶ 9(A)). 

24. ECM admits that it has claimed that the Plastic containing the ECM additive causes 

plastics to degrade through biological means, but denies that it has made unqualified 

plastic elimination claims in advertising concerning the Plastic containing the ECM 

additive in landfills. (Answer ¶ 9(B)). 

25. ECM further states that its advertising plainly explains that the rate of plastic 

degradation is dependent on ambient environmental conditions. (Answer ¶ 9(B)). 

26. Respondent denies that its biodegradable claim is deceptive, false, or misleading in 

any respect. (Answer ¶ 9(B)). 

27. Respondent asserts that it has proven through competent and reliable testing that 

plastics manufactured with the Plastic containing the ECM additive will fully 

biodegrade through biological means when exposed to micro-organisms commonly 

present in the outdoor environment, including in landfills. (Answer ¶ 9(B)). 

C. Procedural Background 

28. Respondent, a small corporation with only six employees, has endured an unusually 

costly and burdensome discovery process throughout this litigation. (Sullivan, Tr. 

699; Sinclair, Tr. 860). 

29. Complaint Counsel’s discovery requests were without limitation, seeking all files 

related to the “ECM additive,” which included virtually every document in ECM’s 

possession, custody or control, without time limitation. (Complaint Counsel’s First 

Set of Requests for Product of Documents; Complaint Counsel’s Second Set of 

Requests for Production of Documents; Complaint Counsel’s Third Set of Requests 

for Production of Documents; Complaint Counsel’s Forth Set of Requests Pursuant to 

Rule 3.37). 

30. Rather than incur the expense of costly motion practice to oppose the overbroad 

requests, ECM reluctantly complied and turned over more than 100,000 pages of 

email communications with, and data base summations concerning communications 

with, customers. (Sinclair, Tr. 860; see e.g., RX 120 (Bates stamped as “ECM 
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114860,” indicating that it was the 114,860th page disclosed by ECM to Complaint 

Counsel). 

31. The parties performed 29 depositions in this case with Complaint Counsel taking 4 

depositions of ECM employees and 21 depositions of non-parties. (CCX 799–CCX 

805; CCX 808–813; CCX 815–822; CCX 943; CCX 1075; RX 841–RX 843; RX 

851; RX 858; RX 970). 

32. Complaint Counsel’s extensive use of discovery forced Respondent to appear 

unrepresented in 8 depositions and have counsel available only telephonically in 6 

depositions. (CCX 800; CCX 803; CCX 801; CCX 810; CCX 811; CCX 812; CCX 

817; CCX 822; CCX 802; CCX 804; CCX 808; CCX 809; CCX 815; CCX 821). 

33. The final pre-hearing conference was held on July 29, 2014, with trial commencing 

on August 5, 2014. 

34. Over 2,000 exhibits were designated prior to the hearing. (JX-1-A). 

35. Respondents submitted into evidence thirty-three (33) scientific studies supporting its 

biodegradability claim. 

36. The testimonial portion of the trial concluded on August 29, 2014 after 15 days of 

trial testimony. 

37. The hearing record was closed on September 4, 2014, pursuant to Commission Rule 

3.44(c), by Order dated August 29, 2014. (Tr. 3002–02), 

38. On September 25, 2014, 2014, the parties filed concurrent post-trial briefs, proposed 

findings of fact, and findings of law. 

D. Evidence Before This Court 

These findings of fact are based on the exhibits properly admitted into evidence, 

the transcripts of testimony at trial, and the briefs submitted by the parties. References to the 

record are abbreviated as follows: 

CCX- Complaint Counsel’s Exhibit 

RX- Respondent’s Exhibit 

Tr.- Transcript of Testimony before the ALJ 

Dep.- Transcript of witness deposition 

JX-3- Joint Stipulations of Law and Facts 
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JX-1-A- Joint Exhibit List dated September 4, 2014 

 Joint Stipulation of the Parties Concerning Scientific Definitions 

II. BACKGROUND OF ECM BIOFILMS, INC. 

39. ECM BioFilms, Inc. is an Ohio-based corporation started by Patrick Riley of MicroTech Research, Inc. in 1998. (Sinclair, Tr. 746, 756–57). 

40. Micro-Tech was found in 1995, and produced a biodegradable MasterBatch pellet 

that renders plastics resins (e.g., polystyrene, polyethylene, and polypropylene) 

biodegradable. (CCX 818 (Sinclair, Dep. at 19)). 

41. ECM’s product is the oldest product on the market, and is a successful cost-effective 

solution for companies looking to reduce long-term environmental impact. (CCX 818 

(Sinclair, Dep. at 120); CCX 820 (Sullivan, Dep. at 56–57); CCX 445)). 

42. Robert Sinclair assumed leadership of ECM Biofilms in 2000. (Sinclair, Tr. 757). 

43. Patrick Riley invented the ECM additive among other inventions. (Sinclair, Tr. 747–

48). 

44. Mr. Riley spent years developing the additive. (Sinclair, Tr. 748). 

45. Mr. Riley tested the additive in Petri dishes, and exposed it to inoculum in his own 

experiments. (Sinclair, Tr. 748). 

46. Mr. Riley tested products in experiments conducted at the University of Akron and at 

a company called Organic Waste Systems. (Sinclair, Tr. 748–49). 

47. Mr. Riley also worked with Timothy Barber, then a principal scientist for a company 

called ChemRisk, to test the ECM additive. (Sinclair, Tr. 749). 

48. During development of the additive, Mr. Riley also worked with Morton Litt, 

Professor of Macromolecular Biology at Case Western Reserve University. (Sinclair, 

Tr. 749). 

49. Mr. Sinclair understood from Patrick Riley that the additive had been tested 

numerous times, in numerous places, and would cause conventional plastics to 

biodegrade in nine months to five years in most circumstances. (Sinclair, Tr. 754–55). 

50. Mr. Sinclair was also understood that both Timothy Barber and Professor Litt 

believed the additive worked. (Sinclair, Tr. 753–54). 
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51. Mr. Sinclair and Mr. Riley each performed home testing of ECM plastics. (Sinclair, 

Tr. 755–56). 

52. Those tests included aerobic testing: burying the plastic in gardens and other places, 

and then digging them up and observing the level of biodegradation. (Sinclair, Tr. 

755). 

53. Mr. Sinclair and Mr. Riley also performed aerobic and anaerobic testing in sealed 

drums. (Sinclair, Tr. 755–56). 

54. In all of those tests, Mr. Sinclair and Mr. Riley observed visual indications of partial 

or complete biodegradation within nine months to five years. (Sinclair, Tr. 756). 

55. Mr. Sinclair received test data from Micro-Tech, including studies demonstrating the 

efficacy of the product, and claim language that had been used with the product in 

commerce. (RX 551; RX 260; RX 263; RX 264; RX 265; RX 269; CCX 241; CCX 

799 (Barber, Dep. 135, 138–141, 266)). 

56. Dr. Barber did work while at McClaren/Hart for Microtech testing the ECM additive. 

(Barber, Tr. 2012). 

57. Dr. Barber analyzed the findings of several tests performed on the Plastic containing 

the ECM additive, and drafted a report containing his findings. (Barber, Tr. 2012–14). 

58. Those tests included biodegradation tests conducted in a laboratory setting, as well as 

post-degradation testing from a toxicity perspective. (Barber, Tr. 2013). 

59. Dr. Barber’s report was based on testing performed by Organic Waste Systems. 

(Barber, Tr. 2014). 

60. Dr. Barber’s report was reviewed by another, disinterested McClaren/Hart scientist 

and received no criticism. (Barber, Tr. 2022–23). 

61. The McClaren/Hart report states that “the results of the aerobic degradation tests 

indicate that, in time, plastics produced using ECM pellets will biodegrade in aerobic 

conditions.” (Barber, Tr. 2024). 

62. That conclusion was based on the Organic Waste Systems laboratory results that 

showed the ECM material biodegraded under the aerobic test conditions performed. 

(Barber, Tr. 2025). 

63. The McClaren/Hart report further states that based on the Organic Waste Systems 

tests, ECM plastics should break down under anaerobic conditions as well, although 

at a slower rate than 100 percent ECM pellets. (Barber, Tr. 2026). 
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64. Although the McClaren/Hart report often uses the phrase “degradation,” that was 

merely a short hand for “biodegradation.” (Barber, Tr. 2027). 

65. Dr. Barber understands “inherent biodegradability” to mean: 

Is the material itself biodegradable and would it biodegrade 

completely at the -- at some point in time, given the proper 

conditions to support biological activity, including microbes, 

water, pH, nutrients, all the things necessary to support biological 

activity. 

(Barber, Tr. 2027). 

66. Dr. Barber conveyed the report and its content to Patrick Riley, then President of 

Microtech (ECM). (Barber, Tr. 2026). 

67. On average, ECM has employed six employees. (CCX 819 (Sinclair, Dep. 327–28)). 

68. Those employees include Robert Sinclair (President and CEO), Kenneth Sullivan 

(CFO), and one or two administrative employees and one or two sales people. 

(Sullivan, Tr. 699). 

69. Mr. Sinclair is primarily responsible for communicating with clients concerning 

ECM’s technology. (Sullivan, Tr. 699). 

III. WITNESSES 

A. ECM’s Fact Witnesses 

1. Robert Sinclair 

70. ECM called Robert Sinclair, President of ECM, Biofilms to testify as a fact witness 

regarding ECM’s claims, marketing methods, biodegradability research, and 

customer characteristics (Sinclair, Tr. 745–797). 

71. Mr. Sinclair is a minority shareholder (12%) in ECM. (Sinclair, Tr. 745). 

72. Mr. Sinclair is also the director and CEO of ECM. (Sinclair, Tr. 745). 

73. Mr. Sinclair manages all daily operations of the company. (Sinclair, Tr. 745). 

74. Mr. Sinclair earned his J.D. from Case Western Reserve University Law School, and 

his undergraduate degree from Dartmouth College. (Sinclair, Tr. 746). 
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75. Mr. Sinclair, although not a scientist, has familiarity with scientific issues and 

experiments. (Sinclair, Tr. 760). 

76. Mr. Sinclair took many biology sciences classes in college, developed resistant strains 

of bacteria for projects, and taught science for six years in the Cleveland and East 

Cleveland public school systems. (Sinclair, Tr. 760). 

77. Mr. Sinclair practiced law until he became President of ECM. (Sinclair, Tr. 746). 

78. Mr. Sinclair became involved with ECM in 1997 after learning about the Plastic 

containing the ECM additive and company from Rob DeMarco, and buying 1% of the 

company after speaking with Patrick Riley. (Sinclair, Tr. 746–47, 747–48). 

79. Mr. Sinclair was deposed in this matter on February 18, 2014 and February 19, 2014. 

(CCX 818–CCX 819). 

80. Mr. Sinclair is a member of the ASTM D20 committee, which is the committee on 

plastics. (Sinclair, Tr. 778). 

81. Mr. Sinclair is the chairman of the ASTM D20.92 subcommittee on plastic 

terminology. (Sinclair, Tr. 778). 

82. Mr. Sinclair is also on the ASTM D20.96 subcommittee on bio-based and 

biodegradable plastics. (Sinclair, Tr. 778). 

83. Mr. Sinclair is on the ASTM D20.95 subcommittee on plastic recyclability. (Sinclair, 

Tr. 778–79). 

84. Mr. Sinclair is also on the ASTM E60 and ASTM E50 committees on sustainability 

and other environmental issues. (Sinclair, Tr. 779). 

85. As a member of numerous ASTM committees and subcommittees, Mr. Sinclair is 

familiar with many current ASTM standards, as well as proposed ASTM standards. 

(Sinclair, Tr. 779). 

2. Kenneth Sullivan 

86. ECM called Kenneth Charles Sullivan, Jr., CFO of ECM Biofilms, to testify as a fact 

witness. (Sullivan, Tr. 690). 

87. Mr. Sullivan has been the CFO of ECM since May of 2009. (Sullivan, Tr. 690–91). 

88. Mr. Sullivan is responsible for all the accounting, finance and treasury functions at 

ECM. (Sullivan, Tr. 691). 
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89. Mr. Sullivan also deals with ECM’s 49 shareholders, the employee benefits plan, 

office administrative staff, and any other functions not associated with sales or 

technical issues. (Sullivan, Tr. 691). 

90. Mr. Sullivan is a CPA and has worked in a financial capacity with multiple 

companies since 1987. (Sullivan, Tr. 691–92). 

91. Mr. Sullivan was deposed in this matter on February 20, 2014. (CCX 820 (Sullivan, 

Dep. at 1)). 

3. Timothy Barber 

92. ECM called Dr. Timothy Barber as a fact witness to testify regarding ECM’s early 

research. (Barber, Tr. 2003–04). 

93. Dr. Barber has a B.S. in chemistry, with a focus in organic chemistry, from State 

University of New York at Binghamton. (Barber, Tr. 2004). 

94. Dr. Barber obtained a Ph.D. in marine science with a specialization in chemistry from 

the University of South Florida. (Barber, Tr. 2005). 

95. Dr. Barber wrote a dissertation on the biogeochemistry of low-molecular-weight 

hydrocarbons in wetland environments. (Barber, Tr. 2005). 

96. Dr. Barber worked at the Florida Marine Research Institute as an analyst and then 

Entix as a senior chemist before taking a position with McLaren/Hart-ChemRisk in 

Cleveland, Ohio. (Barber, Tr. 2005–07). 

97. At the Florida Marine Research Institute, Dr. Barber’s responsibilities included 

collecting data, analyzing data, developing reports, and conducting laboratory work. 

(Barber, Tr. 2006). 

98. At Entix, Dr. Barber’s responsibilities included analyzing data, writing reports, and 

conducting fieldwork. (Barber, Tr. 2006). 

99. McClaren/Hart, which no longer exists, was an environmental consultancy that 

worked primarily for private industry. (Barber, Tr. 2007). 

100. McLaren/Hart employed approximately 350–500 people throughout the United States 

in about 15 different offices. (Barbet, Tr. 2006–07). 

101. Dr. Barber was a consultant at McClaren/Hart assisting companies with pollution 

problems, developing work plans, collecting data, analyzing that information and 

writing reports. (Barber, Tr. 2007). 
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102. After leaving McClaren/Hart, Dr. Barber continued to work in the field of 

environmental contamination and ecological risk assessment for Geraghty & Miller 

(now Arcadis) and Environ International Corporation. (Barber, Tr. 20–09). 

103. At Geraghty & Miller Dr. Barber was a principal scientist. (Barber, Tr. 2008). 

104. Dr. Barber is presently employed at Environ International Corporation as a principal 

scientist and office manager. (Barber, Tr. 2008–09). 

105. Dr. Barber collaborates with other Environ scientists in the conduct of his research 

work. (Barbet, Tr. 2010). 

106. Dr. Barber was the instructor for the chemical oceanography laboratory at the 

University of South Florida and an ecological risk assessment course at that same 

university. (Barber, Tr. 2010–11). 

107. Dr. Barber taught a one-day seminar to the Ohio EPA on forensic chemistry. (Barber, 

Tr. 2011). 

108. Dr. Barber has written approximately thirty (30) peer-reviewed articles on various 

topics related to anthropogenic or manmade chemicals in the environment, potential 

toxicity associated with those, as well as fate and transport, persistence, 

bioaccumulation and ecological risks of those chemicals. (Barber, Tr. 2011). 

109. Dr. Barber is a member of the American Chemical Society, the Environmental 

Toxicology and Chemistry Organization, the International Society of Ecological 

Economics, and the International Society of Environmental Forensics. (Barber, Tr. 

2012). 

110. Dr. Barber was deposed in this matter on March 7, 2014. (RX 870 (Barber, Dep. at 

1)). 

4. Thomas Poth 

111. ECM called Thomas Poth to testify as a fact witness regarding the testing done on the 

ECM additive and ECM plastics by Eden Laboratories. (Poth, Tr. 1434, 1442). 

112. Mr. Poth was deposed in this matter on May 19, 2014. (RX 876 (Poth, Dep. at 1)). 

113. Mr. Poth completed the course requirements for an undergraduate degree from New 

Mexico Institute of Mining and Technology in chemistry and environmental 

engineering. (Poth, Tr. 1435–36). 
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114. Mr. Poth also took numerous courses on hazardous waste management and 

radioactive waste management at the graduate level, but did not receive a degree. 

(Poth, Tr. 1435). 

115. Mr. Poth owns Eden Research Laboratories (Eden Labs), formerly Zia Environmental 

Laboratories. (Poth, Tr. 1437). 

116. Mr. Poth is also the laboratory director at Eden. (Poth, Tr. 1437). 

117. Before starting Eden Labs, Mr. Poth managed a laboratory called Assaigai Laboratory 

in Albuquerque, New Mexico. (Poth, Tr. 1438). 

118. Mr. Poth was then transferred to West Texas to manage another laboratory in the 

Midland area. (Poth, Tr. 1438). 

119. As laboratory manager for both the Assaigai and Texas labs, Mr. Poth oversaw sales, 

marketing, and laboratory testing. (Poth, Tr. 1438). 

120. Mr. Poth then ran the science and engineering design department for RW 

Technologies, a company that developed water treatment systems using cutting-edge 

technology. (Poth, Tr. 1439). 

121. This position required familiarity with environmental testing, among other skills. 

(Poth, Tr. 1440). 

122. Mr. Poth and Eden Laboratories employ two full-time employees, and two part-time 

employees. (Poth, Tr. 1440). 

123. Other than Mr. Poth, Eden’s other full-time employee is Brian Esau, who assists in 

project design and implementation. (Poth, Tr. 1440–41). 

124. Mr. Esau has an undergraduate degree and a Ph.D. in biochemistry. (Poth, Tr. 144–

41). 

125. Mr. Esau worked for Oak Ridge National Laboratory doing cancer research prior to 

his employment at Eden Laboratories. (Poth, Tr. 1443). 

126. Eden Laboratories works with businesses such as Adidas Group, Reebok, Pactiv, 

Saucony, and Georgia Pacific, and also works with smaller companies as well. (Poth, 

Tr. 1443). 

127. Eden Laboratories has performed biodegradability testing of plastic products such as 

plastic bags and drink bottles since 2010. (Poth, Tr. 1444–45). 
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128. Eden Laboratories offers other environmental services, such as digester design for 

treatment of waste streams, solid waste management design, and water treatment 

system design. (Poth, Tr. 1445). 

129. Approximately 50% of Eden Laboratories’ current business is biodegradability 

testing. (Poth, Tr. 1445). 

130. In the past, nearly 75% of Eden Laboratories’ business was biodegradability testing. 

(Poth, Tr. 1445). 

5. Alan Johnson 

131. ECM called Alan Charles Johnson to testify as a fact witness regarding testing that 

was done by Northeast Laboratories. (Johnson, Tr. 1553). 

132. Mr. Johnson has been working at Northeast Laboratories since 1977. (Johnson, Tr. 

1554). 

133. Mr. Johnson is the laboratory director, and he is responsible for overseeing all 

laboratory operations. (Johnson, Tr. 1554). 

134. Before starting Northeast Laboratories, Mr. Johnson earned a bachelor’s degree with 

a major in biology and a minor in chemistry from the University of Connecticut. 

(Johnson, Tr. 1554–55). 

135. Mr. Johnson also took graduate level coursework for a master’s degree in 

microbiology but did not complete the program. (Johnson, Tr. 1555). 

136. Mr. Johnson first worked as an analytical technician for Dairy Control Service 

Laboratory. (Johnson, Tr. 1555). 

137. Mr. Johnson then went to work at Northeast Laboratories, eventually purchasing it. 

(Johnson, Tr. 1555–56). 

138. Mr. Johnson and Northeast Laboratories have fourteen (14) employees, working in 

different disciplines, including biodegradation, wastewater, and microbiology. 

(Johnson, Tr. 1556–57). 

139. Northeast Laboratories has two major branches: chemistry and microbiology. 

(Johnson, Tr. 1557). 

140. Northeast Laboratories is EPA, FDA, USDA, CDC and State of Connecticut certified. 

(Johnson, Tr. 1558). 
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141. Those certifications authorize the lab to test pharmaceutical chemistry, wastewater, 

and pharmaceutical, food and environmental microbiology. (Johnson, Tr. 1558–59). 

142. Generally, all of Northeast Laboratories’ certifications are subject to inspections and 

proficiency testing. (Johnson, Tr. 1559). 

143. Northeast Laboratories has received good reports after being audited by the State of 

Connecticut and the USDA this past year. (Johnson, Tr. 1559–60). 

144. Northeast Laboratories conducts biodegradation testing, and began doing so in 2005. 

(Johnson, Tr. 1560). 

145. The chemistry division of the lab assists biodegradability testing by performing 

titrations, instrumental work, and report writing. (Johnson, Tr. 1560–61). 

146. Mr. Johnson oversees all biodegradability testing, and often does some of the work 

himself. (Johnson, Tr. 1561). 

147. Northeast Laboratories performs ASTM D5511 and ASTM D5538 biodegradability 

testing. (Johnson, Tr. 1561). 

148. Dr. William Ullman had a Ph.D. in microbiology and ran the biodegradability at 

Northeast Laboratories program from its inception in 2005, until his death in 2011. 

(Johnson, Tr. 1562–63). 

149. Prior to purchasing Northeast Laboratories, Dr. Ullman was the director of the State 

of Connecticut Public Health Laboratory. 

150. Dr. William Ullman trained Alyssa Ullman, a chemist for Northeast Laboratories, in 

the discipline. (Johnson, Tr. 1562–63). 

B. ECM’s Expert Witnesses 

1. Dr. Ranajit Sahu 

151. ECM called Dr. Ranajit Sahu, an expert in environmental and applied sciences. 

(Sahu, Tr. 1733–34; RX 855 (Sahu, Rep. at 5–6)). 

152. Dr. Sahu earned his undergraduate degree in mechanical engineering from the Indian 

Institute of Technology. (Sahu, Tr. 1730–31). 

153. The foundational coursework in this degree program involved chemistry, physical 

chemistry, and organic chemistry. (Sahu, Tr. 1732). 
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154. The advanced coursework in this degree program involved the study of metals and 

nonmetals, including plastics and polymers, and the manufacturing processes 

associated with these materials. (Sahu, Tr. 1732). 

155. Dr. Sahu earned a master’s and a Ph.D. in combustion from the California Institute of 

Technology. (Sahu, Tr. 1732). 

156. Within the coursework of these post-graduate programs, Dr. Sahu studied polymer 

science, specifically the applicability of organic chemistry and chemical engineering, 

and the manufacturing of polymers into useful articles. (Sahu, Tr. 1733–34). 

157. Dr. Sahu is a Qualified Environmental Professional (QEP) certified by the Air and 

Waste Management Association. (Sahu, Tr. 1748). 

158. Dr. Sahu is a Certified Environmental Manager (CEM) certified by the State of 

Nevada. (Sahu, Tr. 1758). 

159. Dr. Sahu first worked as a research development engineer at the Heat Transfer 

Research Institute and shortly thereafter at Kinetics Technology International. (Sahu, 

Tr. 1734). 

160. In those capacities, Dr. Sahu designed equipment for use in the petrochemical 

industry. (Sahu, Tr. 1734). 

161. Dr. Sahu then worked for Parsons Corp., a large engineering and architectural firm, 

where he performed environmental consulting often in the area of solid waste 

disposal in landfills, incinerators, and other disposal methods. (Sahu, Tr. 1735–36). 

162. At Parsons Corp., Dr. Sahu managed a testing group, which conducted field-testing, 

laboratory testing, third party laboratory analysis, and data evaluation. (Sahu, Tr. 

1736–37). 

163. Since leaving Parsons Corp. in December 1999, Dr. Sahu has been an independent 

consultant, providing a variety of consulting services in a wide range of fields. (Sahu, 

Tr. 1737). 

164. Dr. Sahu has over twenty years of experience in the field of chemical engineering, 

spanning from undergraduate studies through post-graduate employment at Parsons 

Corp. and as an independent consultant. (Sahu, Tr. 1738). 

165. More specifically, Dr. Sahu has extensive experience in the field of polymer science. 

(Sahu, Tr. 1738–39). 
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166. Dr. Sahu spent three or four years as an independent consultant working with various 

bathroom fixture manufacturers to assess the degradation and manufacturing waste of 

their polystyrene and styrene-based products. (Sahu, Tr. 1739–40). 

167. Dr. Sahu has also worked extensively in the field of polymer material properties, 

structure, composition and manufacture as an independent consultant with fuel 

industry consortia. (Sahu, Tr. 1740–41). 

168. Dr. Sahu has conducted multiple projects dealing with waste containment in landfills, 

including MSW landfills. (Sahu, Tr. 1741–42). 

169. Dr. Sahu has worked on multiple projects involving MSW landfill gas extraction, 

treatment, and measurement. (Sahu, Tr. 1742–44). 

170. Dr. Sahu’s work with MSW landfills has also included leachate collection. (Sahu, Tr. 

1744). 

171. Dr. Sahu currently works with a small development company managing a major 

project involving the siting, construction and closure of a four million cubic yard 

landfill. (Sahu, Tr. 1744–45). 

172. As project manager and the principal in charge, Dr. Sahu designed every aspect of the 

landfill construction plan, supervised construction, and oversaw storm water 

management and leachate disposal. (Sahu, Tr. 1745). 

173. Dr. Sahu has worked with municipalities, states, and the U.S. EPA. (Sahu, Tr. 1746). 

174. Dr. Sahu has held various adjunct teaching positions with a number of universities in 

Southern California. (Sahu, Tr. 1746–47). 

175. Dr. Sahu has been retained and qualified as an expert witness in environmental 

matters in multiple administrative proceedings and several state and federal judicial 

proceedings. (Sahu, Tr. 1747). 

176. Dr. Sahu has been a member of the ASTM for three or four years, and currently 

serves on numerous committees. (Sahu, Tr. 1750). 

177. Dr. Sahu was heavily involved with the ASTM on a project regarding the introduction 

of ethanol into the fuel mix. (Sahu, Tr. 1750). 

178. In that capacity, Dr. Sahu advised the ASTM on the interaction of the fuel mix with 

plastics and polymers in fuel systems. (Sahu, Tr. 1750). 

179. Due to this involvement and his work as an independent consultant, Dr. Sahu is very 

familiar with a wide range of ASTM standards and protocols. (Sahu, Tr. 1750–51). 
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180. Dr. Sahu authored and submitted an expert report in this matter on June 18, 2014. 

(Sahu, Tr. 1737; RX 855 (Sahu, Rep. at 1)). 

181. Dr. Sahu was deposed in this matter on June 30, 2014. (RX 842 (Sahu, Dep. at 1)). 

2. Dr. Morton Barlaz 

182. ECM called Dr. Morton Barlaz, as an expert witness in biodegradation in MSW 

landfills. (Barlaz, Tr. 2166; RX 853 (Barlaz, Rep. at 27)). 

183. Dr. Barlaz authored an expert report in this matter on June 15, 2014. (Barlaz, Tr. 

2170); RX 853 (Barlaz, Rep. at 3)). 

184. Dr. Barlaz was deposed in this matter on July 14, 2014. (RX 864 (Barlaz, Dep. at 1)). 

185. Dr. Barlaz is professor and head of the Department of Civil Construction and 

Environmental Engineering at North Carolina State University. (Barlaz, Tr. 2167). 

186. He runs a research program for the University in the area of solid waste management, 

and more specifically, biodegradation, decomposition, chemical and biological 

reactions in landfills, and the application of life cycle analysis to solid waste 

management systems. (Barlaz, Tr. 2168). 

187. Dr. Barlaz has an undergraduate degree in chemical engineering from the University 

of Michigan and a master’s and Ph.D. in civil and environmental engineering from 

the University of Wisconsin. (Barlaz, Tr. 2168). 

188. Dr. Barlaz’s Ph.D. focused on the microbiology of solid waste decomposition in 

landfills. (Barlaz, Tr. 2168). 

189. Dr. Barlaz has published approximately 115 peer-reviewed publications and one-half 

to two-thirds of those are associated with some aspect of biodegradation. (Barlaz, Tr. 

2169–70). 

190. In his research program at North Carolina State University, Dr. Barlaz has conducted 

numerous tests on the biodegradation of various components of municipal solid 

waste. (Barlaz, Tr. 2071). 

191. Dr. Barlaz has performed anaerobic biodegradability tests at reactor scale, vessels 

from one-half to two and a half gallons, measuring methane generation from 

municipal solid waste or specific components of municipal solid waste. (Barlaz, Tr. 

2171). 

192. Dr. Barlaz has also performed biochemical methane potential tests, which are tests of 

anaerobic biodegradability. (Barlaz, Tr. 2171–72). 
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193. Dr. Barlaz has performed qualitative testing of anaerobic biodegradability in fifty-five 

(55) gallon drums. (Barlaz, Tr. 2172). 

194. Dr. Barlaz is not only familiar with the ASTM and their protocols, but has drafted a 

protocol for radiolabel testing of biodegradability that was ultimately adopted by the 

ASTM. (Barlaz, Tr. 2172). 

195. Dr. Barlaz recently completed a project funded by the Plastics Environmental Council 

to evaluate the effect of different inocula on biodegradation rates for the purpose of 

developing a protocol for biodegradability testing that is more flexible than the 

ASTM 5511 protocol. (Barlaz, Tr. 2172–73). 

196. Complaint Counsel’s expert, Dr. Tolaymat, recognizes Dr. Barlaz as an authority in 

the field of biodegradability of municipal solid waste and landfill gas. (Tolaymat, Tr. 

156, 184, 233). 

197. Dr. Tolaymat has consulted Dr. Barlaz on a number of questions concerning landfill 

biodegradation. (Tolaymat, Tr. 233). 

198. When asked if he has ever asked Dr. Barlaz to comment on his work, Dr. Tolaymat 

responded “of course.” (Tolaymat, Tr. 234). 

199. Dr. Barlaz has reviewed Dr. Tolaymat’s work product and Dr. Tolaymat has accepted 

a number of his recommendations for his work. (Tolaymat, Tr. 234). 

200. Dr. Tolaymat co-authored an article that defined “bioreactor landfill” the same way as 

Dr. Barlaz does. (Tolaymat, Tr. 337–38; RX 899; RX 900; RX 901). 

3. Dr. Ryan Burnette 

201. ECM called Dr. Ryan Nelson Burnette as an expert in microbiology, biochemistry 

and anaerobic microorganisms. (Burnette, Tr. 2364–65; RX 854 (Burnette, Rep.)). 

202. Dr. Burnette earned his undergraduate degree in biochemistry and two minors in 

chemistry and environmental sciences from Virginia Polytechnic Institute and State 

University. (Burnette, Tr. 2360). 

203. Dr. Burnette’s undergraduate coursework included organic chemistry, general 

biochemistry, microbiology, molecular biology, genetics, enzymology, and enzyme 

kinetics. (Burnette, Tr. 2361). 

204. Dr. Burnette also earned a Ph.D. in biochemistry and molecular biology from 

Virginia Polytechnic Institute and State University. (Burnette, Tr. 2361). 
 PUBLIC DOCUMENT 

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205. Dr. Burnette’s doctoral dissertation focused on signal transduction via enzymatic 

pathways with response to environmental stimulus, how organisms respond to their 

environment, the signaling cascades, the small molecules, the enzymes involved in 

that signal transduction pathway, applied across a variety of organisms. (Burnette, Tr. 

2361). 

206. Dr. Burnette studied within the Department of Biochemistry which studies anaerobic 

microbiology and general biochemistry. (Burnette, Tr. 2363). 

207. Dr. Burnette was also a National Institute of Health Fellow at Vanderbilt University 

School of Medicine where he studied signal transduction and enzyme pathways. 

(Burnette, Tr. 2364). 

208. Dr. Burnette has taught biochemistry, molecular biology, microbiology and genetics 

at the undergraduate, masters and doctoral levels, as well as to medical students. 

(Burnette, Tr. 2364–65). 

209. Dr. Burnette has worked with numerous pre-eminent microbiologists in the field of 

anaerobic microbiology. (Burnette, Tr. 2365). 

210. Much of Dr. Burnette’s own research involves anaerobic microorganisms. (Burnette, 

Tr. 2365–66). 

211. Dr. Burnette worked for Hatcher-Sayre, Inc., an environmental consulting firm, as an 

environmental scientist testing soil samples, landfills, groundwater, and water. 

(Burnette, Tr. 2366). 

212. Dr. Burnette is currently the Vice President of the Biological Safety Division at 

WIRB-Copernicus Group (WCG), a clinical services organization that provides 

support to a variety of biopharmaceutical and academic research programs. (Burnette, 

Tr. 2367). 

213. Dr. Burnette and the WCG assist customers with the design of laboratories, 

containment, disinfection, decontamination, and infection prevention. (Burnette, Tr. 

2367–68). 

214. WCG’s clients include major biopharmaceutical firms, academic research institutions, 

and government entities such as the CDC. (Burnette, Tr. 2368). 

215. Dr. Burnette authored and submitted an expert report in this matter. (Burnette, Tr. 

2370; RX 854 (Burnette, Rep.)). 

216. Dr. Burnette was deposed in this matter on July 2, 2014. (CCX 1075 (Burnette, Dep. 

at 1)). 
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4. Dr. David Stewart 

217. ECM called Dr. David Wayne Stewart, as a survey expert, to present the method and 

findings of his own study and opine on the validity of Complaint Counsel’s surveys 

and conclusions. (Stewart, Tr. 2491). 

218. Dr. Stewart is currently the President’s Professor of Marketing and Business Law at 

Loyola Marymount University. (Stewart, Tr. 2492). 

219. Dr. Stewart received an undergraduate degree in psychology from the University of 

Louisiana at Monroe, then Northeast Louisiana University. (Stewart, Tr. 2494). 

220. Dr. Stewart also earned a master’s degree in general psychology from Baylor 

University and a Ph.D. in personality and social psychology from Baylor University. 

(Stewart, Tr. 2495). 

221. Dr. Stewart currently teaches advertising and promotion management, marketing 

strategy, and the introductory MBA marketing course at Loyola Marymount. 

(Stewart, Tr. 2496). 

222. Prior to holding his current position, from July 2007 through July 2011, Dr. Stewart 

was Dean of the School of Business at the University of California at Riverside. 

(Stewart, Tr. 2496). 

223. Dr. Stewart has also served as the Robert E. Brooker Professor of Marketing and 

Chairman of the Department of Marketing in the Marshall School of Business at the 

University of Southern California. (Burnette, Tr. 2497). 

224. Prior to these positions, Dr. Stewart served as the Senior Associate Dean of the Owen 

Graduate School of Management at Vanderbilt, and was a member of the faculty in 

the psychology department and business school at Jacksonville State University in 

Jacksonville, Alabama. (Stewart, Tr. 2498). 

225. Dr. Stewart has taught extensively in the field of conduct and methodology of 

surveys, teaching marketing research at the undergraduate, graduate, and doctoral 

levels. (Stewart, Tr. 2498). 

226. He has also taught courses on research methodology, psychometrics, and 

experimental design. (Stewart, Tr. 2499). 

227. Prior to his work in education, Dr. Stewart was a research manager for Needham, 

Harper & Steers Advertising in Chicago (now DDB). (Stewart, Tr. 2499). 

228. In that capacity, Dr. Stewart provided internal consultation services on research 

design, conducted an annual omnibus lifestyle survey of consumers in the United 
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States, and tested creative content prior to its presentation to clients. (Stewart, Tr. 

2499–2500). 

229. Dr. Stewart has served as the Editor of both the Journal of Marketing and the Journal 

of the Academy of Marketing Science. (Stewart, Tr. 2500). 

230. He is currently serving as the Editor of the Journal of Public Policy and Marketing. 

(Stewart, Tr. 2500). 

231. Approximately half of the papers submitted to those three journals use survey 

methodology as a basis for empirical presentation. (Stewart, Tr. 2500). 

232. As Editor, Dr. Stewart has reviewed those papers and the survey methodology used in 

their preparation. (Stewart, Tr. 2500–01). 

233. Dr. Stewart has published in excess of 200 peer reviewed journals, proceedings 

volumes, and book chapters, over half of which contained survey research. (Stewart, 

Tr. 2501). 

234. Dr. Stewart has been awarded numerous awards, including the American Academy of 

Advertising’s Outstanding Contribution to Advertising Research Award, the 

Academy of Marketing Science’s Cutco/Vector Distinguished Marketing Educator 

Award, and the Society for Marketing Advances’s Elsevier Distinguished Marketing 

Contribution Award. (Stewart, Tr. 2501). 

235. Dr. Stewart is a member of the following academic and trade associations: 

 The American Marketing Association 

 The American Statistical Association 

 INFORMS (management science professional organization) 

 The Association for Consumer Research 

 The Society for Consumer Psychology 

 The Classification Society 

 The Society for Personality and Social Psychology 

 The Academy of Management 

(Stewart, Tr. 2501–02). 
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236. Dr. Stewart is a past president of the Society for Consumer Psychology. (Stewart, Tr. 

2502). 

237. Dr. Stewart is a past president of the Academic Council for the American Marketing 

Association. (Stewart, Tr. 2502) 

238. He has also served on the American Marketing Association’s board of directors and 

as its vice president of finance. (Stewart, Tr. 2502–03). 

239. Dr. Stewart has chaired the research committee of the American Academy of 

Advertising. (Stewart, Tr. 2503). 

240. Dr. Stewart has also served as representative to the council of the American 

Psychological Association on behalf of the Society for Consumer Research. (Stewart, 

Tr. 2503). 

241. In the 1990’s, Dr. Stewart served two, three year terms as a member of the joint 

professional advisory committee to the United States Census, and in that role advised 

the Census Bureau in the design of its various data collection activities, including the 

census. (Stewart, Tr. 2503–04). 

242. In 2009, Dr. Stewart served as part of a panel of academics that evaluated the 

marketing plan for the 2010 decennial census, and submitted their report to Congress. 

(Stewart, Tr. 2504). 

243. He is a past appointee of the Secretary of Commerce to the Southern California Direct 

Export Council which facilitates the export of American goods and services to 

international markets. (Stewart, Tr. 2504). 

244. The FTC Complaint Counsel emailed Dr. Stewart and expressed interest in him 

serving as Complaint Counsel’s expert witness in this matter; however, he had 

already been retained by ECM. (Stewart, Tr. 2504–05). 

245. Dr. Stewart has served as an expert witness for the FTC multiple times. (Stewart, Tr. 

2505). 

246. In the late 1980’s, Dr. Stewart designed and implemented a survey for the FTC in 

connection with a deceptive advertising case against Kraft. (Stewart, Tr. 2505). 

247. In the Kraft decision, Dr. Stewart’s survey was credited by the ALJ and cited by the 

full commission as supportive of its decision. (Stewart, Tr. 2506). 

248. Dr. Stewart was retained as an expert by the FTC in a matter involving Novartis. 

(Stewart, Tr. 2507). 
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249. Dr. Stewart was also an FTC expert in the POM Wonderful matter. (Stewart, Tr. 

2507). 

250. Dr. Stewart was retained as an expert by the FTC in matters against QVC, Neurologic 

Labs, and John Beck. (Stewart, Tr. 2507–08). 

251. Dr. Stewart has also been retained by various Respondents in cases brought by the 

FTC, including Pantron, Schering, and Guaranty Life. (Stewart, Tr. 2507–08). 

252. In most of the cases Dr. Stewart opined on surveys; in approximately half of those 

cases Dr. Stewart designed a survey, and in many of those cases Dr. Stewart gave 

rebuttal testimony concerning the opposing party’s surveys. (Stewart, Tr. 2508:18-

2509:3). 

253. Dr. Stewart is unaware of a single instance in which his testimony or survey was not 

credited by either the ALJ or the Commission. (Stewart, Tr. 2509). 

254. Dr. Stewart has served as a survey expert in federal court “a couple of dozen times” 

and in none of those cases has his survey been deemed to be unreliable or not credited 

by the court. (Stewart, Tr. 2520–21). 

255. Dr. Stewart prepared and submitted an expert report in this matter on June 17, 2013. 

(Stewart, Tr. 2492; RX 856 (Stewart, Rep. at 1)). 

C. Complaint Counsel’s Fact Witnesses 

256. Between February 18, 2014 and May 30, 2014, Complaint Counsel performed sixteen 

(16) fact depositions of testing laboratories and ECM customers all over the country, 

including Hawaii, California, New York, Ohio, and the District of Columbia. (CCX 

799–CCX 805; CCX 809–812; CCX 815; CCX 817; CCX 821–CCX 823). 

257. Complaint Counsel called no (0) fact witnesses at trial. (Tr. 259). 

258. Respondent was unrepresented, or had counsel appear telephonically, at 14 fact 

witness depositions. (CCX 800; CCX 803; CCX 801; CCX 810; CCX 811; CCX 

812; CCX 817; CCX 822; CCX 802; CCX 804; CCX 808; CCX 809; CCX 815; CCX 

821). 

D. Complaint Counsel’s Expert Witnesses 

1. Thabet Tolaymat 
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259. Complaint Counsel called Dr. Thabet Tolaymat as their landfill expert. (Tolaymat, Tr. 

112–358). 

260. Dr. Tolaymat authored an expert report dated June 4, 2014. (CCX 893 (Tolaymat, 

Rep. at 1)). 

261. In his report, Dr. Tolaymat opined on the scientific reliability and the applicability of 

ECM’s biodegradability testing. (CCX 893 (Tolaymat, Rep.)). 

262. In his report, Dr. Tolaymat criticized tests relied upon by ECM for failing to simulate 

actual conditions in an MSW landfill, and discounts the testing results in their entirety 

on that basis. (CCX 893 (Tolaymat, Rep. 1)). 

263. Dr. Tolaymat drew his conclusions without any knowledge of the bacterial 

communities present in MSW landfills or the testing environment. (Tolaymat, Tr. 

265–267). 

264. Dr. Tolaymat was deposed on June 24, 2014. (CCX 851 (Tolaymat, Dep. at 1)). 

2. Stephen McCarthy 

265. Complaint Counsel called Dr. Stephen McCarthy as their primary expert witness in 

the areas of general biodegradation, biodegradability of plastics and biodegradability 

testing methodologies. (McCarthy, Tr. 359-480). 

266. Dr. McCarthy authored an expert report on June 4, 2014. (CCX 891 (McCarthy, Rep. 

at 1)). 

267. In his report, Dr. McCarthy opined that all thirty-three of ECM’s positive 

biodegradation tests were flawed, that the flaws invalidate any findings of 

biodegradation, and to the extent that many of the tests indicate the occurrence of 

biodegradation, that data is the result of a so-called “priming effect.” (CCX 891 

(McCarthy, Rep. at 7–8)). 

268. Dr. McCarthy stands to profit personally from FTC rejection of the biodegradability 

of ECM plastics and the entire biodegradable plastic additive industry. (McCarthy, 

Tr. 523–524). 

269. Complaint Counsel wrote the definition of the term “biodegradable” contained in 

footnote 1 of Dr. McCarthy’s expert report. (RX 841 (McCarthy, Dep. at 20)). 

270. That definition reads: 
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[B]iodegradable means that the entire treated plastic will 

completely break down and return to nature (i.e. decompose into 

elements found in nature) within one year after customary disposal 

(i.e. incinerator, landfill, or recycling). 

(CCX 891 (McCarthy, Rep. at 5 n. 1)). 

271. Dr. McCarthy tailored his definition of “biodegradable” to comport with Complaint 

Counsel’s definition despite Dr. McCarthy’s use of conflicting definitions in prior 

research and publication. (McCarthy, Tr. 485–88, 494). 

272. Dr. McCarthy wrote the following sentence contained in footnote 1 of his expert 

report: “I use this definition and the scientific definition of biodegradable 

interchangeably in this Expert Report, because there is no substantive difference 

between the two that affects my analysis or my opinions.” (McCarthy, Tr. 487; CCX 

891 (McCarthy, Rep. at 5 n. 1)). 

273. Dr. McCarthy was unable to identify a single instance in the peer-reviewed literature 

in which the definition of “biodegradable” contained in his Expert Report at footnote 

1 is recited. (McCarthy, Tr. 493–94). 

274. During cross-examination concerning his reliance on the term “biodegradable” 

contained in footnote 1 of his expert report, Dr. McCarthy stated that he “would like 

to change that.” (McCarthy, Tr. 496). 

3. Shane Frederick 

275. Complaint Counsel called Dr. Shane Frederick as their survey expert. (Frederick, Tr. 

1025–1181). 

276. Dr. Frederick produced an expert report on June 4, 2014. (CCX 890 (Frederick, Rep. 

at 1)). 

277. In this report, Dr. Frederick opined that: 

i. Roughly half of all consumers believe that products with an unqualified 

“biodegradable” claim will biodegrade in one year or less. 

ii. A substantial minority (20-30%) of consumers believe that a plastic 

product bearing an unqualified “biodegradable” claim will biodegrade 

within a year. 

iii. If a plastic package bears the claim that it biodegrades in “some period 

greater than a year,” 29% of consumers assume it will biodegrade in two 

years or less, and 54% assume it will biodegrade in five years or less. 
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iv. Consumers infer similar periods of biodegradation whether the qualified 

claim states “in some period greater than a year” or “nine months to five 

years.” 

(CCX 890 (Frederick, Rep. at 1)). 

Dr. Frederick based those conclusions in part on studies he regards as flawed and 

invalid, referred to as the APCO study and the Synovate study. (Stewart, Tr. 2618; 

Frederick, Tr. 1042–43, 1045, 1047; CCX 890 (Frederick, Rep. at 7–16, 20)). 

278. Dr. Frederick further based his conclusions on his own Google survey. (Stewart, Tr. 

2614–18; Frederick, Tr. 1060). 

279. Moreover, Dr. Frederick conducted his Google survey with the intention of correcting 

the flaws he admits pervade the APCO study, while maintaining the flawed 

conclusion in the APCO study. (Stewart, Tr. 2616, 2618–19). 

280. Dr. Frederick was deposed in this matter on June 23, 2014. (RX 858 (Frederick, Dep. 

at 1)). 

4. Frederick Michel 

281. Dr. Frederick C. Michel, Jr. was called to rebut the testimony of two ECM expert 

witnesses, Dr. Sahu and Dr. Burnette. (Michel, Tr. 2839). 

282. Dr. Michel was deposed in this matter on July 31, 2014. (RX 970 (Michel, Dep. at 

1)). 

283. Dr. Michel prepared a rebuttal report purportedly based on Dr. Burnette’s and Dr. 

Sahu’s expert reports. (Michel, Tr. 2839; CCX 895 (Michel, Rebuttal Rep.)). 

284. Dr. Michel also provided his Curriculum Vitae. (Michel, Tr. 2840; CCX 896). 

285. Dr. Michel serves as editor of the Compost Science & Utilization Journal, and attends 

U.S. Composting Council meetings. (Michel, Tr. 2834, 2837). 

286. Dr. Michel is the head of the compost research group for Ohio Agricultural Research 

and Development Center-Food, Agricultural, and Biological Engineering (“OARDCFABE”). (Michel, Tr. 2918). 

287. Dr. Michel was the coeditor for proceedings at the 2002 Symposium on Composting 

and Compost Utilization. (Michel, Tr. 2918). 

288. Dr. Michel was also the section editor for Test Methods for the Examination of 

Composting and Compost (TMECC). (Michel, Tr. 2918–19). 
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289. Dr. Michel is a paid consultant for AllTreat Organic Composting. (Michel, Tr. 2919). 

290. Dr. Michel is a consultant for DuPont, a member of the Biodegradable Products 

Institute (BPI). (Michel, Tr. 2919–20; RX 169). 

291. DuPont also provided Dr. Michel with grant money. (Michel, Tr. 2920). 

292. Dr. Michel is a paid consultant for Indian Summer Composting. (Michel, Tr. 2920). 

293. Dr. Michel has consulted for the U.S. Composting Council for “six or seven years.” 

(Michel, Tr. 2920–21). 

294. Dr. Michel also consulted for Amylex and International Paper, companies that sell 

compostable products, and receives grant money for Ohio State University in return. 

(Michel, Tr. 2921–22). 

295. The composting industry generally, and compostable plastics specifically, directly 

compete with ECM and other companies within the biodegradable plastics industry. 

(Sullivan, Tr. 696–697; Sinclair, Tr. 775–777). 

IV. ECM’S CUSTOMERS 

A. ECM’s Customers Are All Sophisticated Plastic Manufacturers 

That Do Not Base Their Purchasing Decisions Of The ECM 

Additive On Any Rate Claim—Whether Implied Or Explicit—

Made By ECM 

296. ECM’s promotional and marketing information is exchanged through detailed 

business transactions with sophisticated corporations, to wit, plastics manufacturers. 

(Sinclair, Tr. 761–67). 

297. ECM does not sell the Plastic containing the ECM additive to end use consumers, 

only to plastics manufacturers. (Sinclair, Tr. 758–59, 764–67; Sullivan, Tr. 703–04, 

707). 

298. The Plastic containing the ECM additive is not usable by a consumer, only by plastics 

manufacturers who manufacture plastics with the Plastic containing the ECM additive 

included as an additive. (Sinclair, Tr. 759). 

299. To be effectual, the additive must be manufactured in strict accordance with ECM 

manufacturing specifications. (Sinclair, Tr. 787–790). 
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300. ECM’s advertising budget is less than $12,000 per year, which is mainly devoted to 

website maintenance. (Sullivan, Tr. 700). 

301. ECM does not have a nationwide advertising plan. (Sullivan, Tr. 700–01). 

302. ECM does not purchase ads in trade magazines. (Sullivan, Tr. 701). 

303. ECM does not purchase any consumer-type advertising. (Sullivan, Tr. 701). 

304. ECM markets its technology through sales meetings, published material (e.g., 

brochures), and networking functions. (Sullivan, Tr. 735). 

305. ECM may acquire customer leads from a personal contact by Tom Nealis at a trade 

show, but that is rare. (Sullivan, Tr. 701). 

306. A common way that ECM acquires customer leads is through website inquiries by 

plastics manufacturers or distributors. (Sullivan, Tr. 701–02). 

307. ECM’s sales are complex business transactions that take months or years to complete, 

in contrast with retail sales to end-consumers. (Sullivan, Tr. 703–04). 

308. In the first instance, ECM offered its “9 month to 5 year” degradable claim not as a 

performance claim, but as a means to distinguish its technology from competing 

technologies claiming to satisfy short-term compostability standards. (Sinclair, Tr. 

768; Sullivan, Tr. 711). 

309. ECM’s customers were aware of the FTC’s requirements in the Green Guides, and 

they tailored their advertising content according to those policies. (RX 35–RX 77; RX 

871 (Blood, Dep. 193:10–21)). 

310. ECM always explained the actual rate of biodegradation for each specific plastic to 

customers as being an approximation that was, of course, subject to numerous 

disposal conditions. (Sinclair, Tr. 769). 

311. ECM explained to customers that it had seen products biodegrade in less than nine 

months in some conditions, however, conditions in an extremely dry or cold climate 

might result in biodegradation in far more than five years. (Sinclair, Tr. 769–70). 

312. The time frame was always expressed as a general time frame based on anecdotal 

experience and on the testing that ECM had performed by third party laboratories. 

(Sinclair, Tr. 770). 

313. The FTC revised its Green Guides to prohibit unqualified biodegradable claims 

without suitable qualifications in 2012. (RX 347). 
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314. ECM stopped using the nine months to five year time frame approximately three 

years ago after the revision of the Green Guides was released. (Sinclair, Tr. 769–70). 

315. Mr. Sinclair felt that the literal interpretation of ECM’s timeframe claims was more of 

an obstacle than a benefit, and ECM discontinued making such claims. (Sinclair, Tr. 

770). 

316. Once the most recent revision of the Green Guides required a product to fully 

biodegrade within one year to make an unqualified “biodegradable” claim, ECM 

determined that it had to qualify its claim to satisfy the FTC regulation. (Sinclair, Tr. 

771) 

317. From that point on, ECM has stated that its plastics infused with the ECM additive 

would biodegrade in some timeframe greater than one year. (Sinclair, Tr. 771). 

318. ECM has no intention of ever making the nine month to five year claim again. 

(Sinclair, Tr. 771). 

319. Almost invariably, the end-customer is provided with a naked “biodegradable” claim, 

which is the only claim ECM has in its certificate of biodegradability. (RX 00; RX 

02; RX 03; RX 14; RX 15; RX 16; RX 17; RX 22; RX 26; RX 28; RX 29; RX 30; 

RX 315; CCX-30 ; CCX-31; CCX 32; CCX 36; CCX 39; CCX 43; CCX 46; CCX 

47; CCX 49; CCX 50; CCX 52; CCX 59; CCX 60; CCX 63’ CCX 64; CCX 65; CCX 

66; CCX 79; CCX 97; CCX 98; CCX 99; CCX 100; CCX 101; CCX 103;CCX 104; 

CCX 107; CCX 109–CCX 133; CCX 135; CCX 136; CCX 138; CCX 139; CCX 140; 

CCX 142–CCX 151). 

320. In its Certificate of Biodegradability, which is given to every customer that confirms 

that it will make its plastic in accordance with ECM’s manufacturing specifications, 

the following definition is given by ECM to its customers of “biodegradation:” 

A degradable plastic is defined (ASTM D883-12) as a plastic that 

is designed to undergo a significant change in its chemical 

structure under specific environmental conditions resulting in a 

loss of some properties that may vary as measured by standard test 

methods appropriate to the plastic and the application in a period 

of time that determines its classification. A Biodegradable Plastic 

is defined as a degradable plastic in which the degradation results 

from the action of naturally occurring microorganisms such as 

bacteria, fungi, and algae. 

(CCX 14; Sinclair, Tr. 784). 
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321. ECM customers are not concerned with the rate of biodegradability. (Sinclair, Tr. 

770). 

322. The ECM additive is sold in a highly competitive market. (Sinclair, Tr. 775). 

323. ECM’s competitors include other additive companies, replacement resin companies, 

and oxo-degradable companies. (Sinclair, Tr. 775–77). 

324. ECM has direct competitors who produce similar additives, invented after ECM’s, 

such as Biotech and Ecoplast. (Sinclair, Tr. 776–77). 

325. There are competing technologies available, such as “bioplastics” which are 

biodegradable plastic polymers or resins derived from biological substances instead 

of petroleum. (Sahu, Tr. 1758; RX 748; RX 678). 

326. Bioplastic can be either non-biodegradable, such as bio-based polyethylene, or they 

can be biodegradable, such as polyhydroxyaldehyde. (RX 748) 

327. Many of the bioplastic technologies will produce an end-product that biodegrades 

more rapidly or readily than plastics made with the ECM additive in an industrial 

composting operation. (RX 725; RX 178). 

328. However, bioplastic technologies come at a substantial cost, (Sullivan, Tr. 697; 

Sinclair, Tr. 768; RX 335), and bioplastics are ordinarily not suitable for strong 

plastics that are meant for applications that require endurance and lack of 

malleability. (Sahu, Tr. 1821–24). 

329. ECM customers purchase the ECM additive in part because it provides them with a 

biodegradable product without many of the drawbacks that come with using ECM’s 

competitors’ technologies. (Sinclair, Tr. 774–75). 

330. ECM offers a cost-effective means to achieve biodegradable plastics. (Sullivan, Tr. 

697; RX 335). 

331. ECM Customers are interested in a “biodegradable” product that can work with their 

manufacturing systems, because the plastic has to serve a function foremost. 

(Sullivan, Tr. 709; RX 111). 

332. Replacement resin companies, such as Metabolix, provide a biodegradable or 

compostable plastics solution, but it requires a complete replacement of the resin. 

(Sinclair, Tr. 776). 

333. Companies choosing to invest in most bioplastics must change their entire 

manufacturing process to accommodate the use of the new natural resins. (Sullivan, 

Tr. 696; RX 520). 
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334. ECM customers have complained to Mr. Sinclair that oxo-degradable or oxobiodegradable products have disintegrated in the warehouse on a hot summer day. 

(Sinclair, Tr. 775). 

335. Additional additives are needed to stabilize the Bioplastics during the manufacturing 

process for the intended use of the end product. (RX 520). 

336. Complaint Counsel’s expert Frederick Michel admits that the bio-based polymers are 

almost always significantly more expensive than ECM’s additive. (Michel, Tr. 2977–

78; RX 520). 

337. Because the ECM additive can render a plastic biodegradable with load rates of just 

over 1% by weight, plastics manufacturers are not required to make substantial 

changes to their manufacturing processes to accommodate the additive, which, when 

properly manufactured, is included in the plastic in much the same way a colorant or 

plasticizer is diffused throughout plastic, thus ensuring uniform distribution in every 

part of the plastic. (Sullivan, Tr. 697; RX 326; RX 520). 

338. ECM’s additive technology has a much smaller impact on manufacturers’ cost basis 

than bioplastic alternatives. (Sullivan, Tr. 697:6-22; RX 520). 

339. With ECM’s technology, the biodegradable component is an option manufacturers 

can implement, thus helping the environment, where they would otherwise not have 

the resources or financial incentive to invest in different, more expensive competing 

technologies. (RX 520; CCX 809 (Sandry, Dep. at 14–15)). 

340. ECM’s customers are primarily concerned with the balance between biodegradable 

effectiveness and product performance (i.e., tensile strength, shelf-life, etc.) after the 

ECM additive is included. (CCX 811 (Hong, Dep. at 44); RX 13; RX 33). 

341. ECM tells its customers that adding the ECM additive to their plastics will render 

their products biodegradable without negatively affecting product performance. 

(Sinclair, Tr. 767). 

342. ECM plastics do not lose physical properties as a result of the additive infusion like 

oxo-degradable or oxo-biodegradable plastics. (Sinclair, Tr. 775). 

343. ECM explains that shelf-life and usable-life will not be negatively affected by 

infusion of the ECM additive. (Sinclair, Tr. 767; RX 13). 

344. The fact that the addition of the ECM additive does not impact shelf-life and usablelife of the plastic products distinguishes ECM from many of its competitors. 

(Sinclair, Tr. 767; RX 13). 
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345. The ECM additive is a cost-effective biodegradability solution for plastic 

manufacturers that will not reduce shelf life, product durability, or recyclability. 

(Sinclair, Tr. 767–68; RX 33). 

346. Bioplastics are often suitable only for certain limited uses in the market. (RX 335). 

347. Oxo-degradable plastic additives have not been shown to biodegrade under realistic 

conditions, but they have been shown to fall apart on the shelf. (Sinclair, Tr. 776:12-

23). 

348. ECM plastics are recyclable to the extent the plastic would be recyclable without the 

addition of the ECM additive. (Sinclair, Tr. 767). 

349. In most cases, ECM’s potential customer contacts ECM directly. (Sinclair, Tr. 761). 

350. ECM employs a sales manager, Tom Nealis. (Sullivan, Tr. 698–700). 

351. However, ECM employs no active sales force. (Sullivan, Tr. 699). 

352. A potential customer will be put in contact with Tom Nealis, director of sales, and he 

will provide the potential customer with pricing, sales literature and any other initial 

information that customer requires. (Sinclair, Tr. 761). 

353. Mr. Sinclair will often work with the marketing and sales people to educate them on 

the new product. (Sinclair, Tr. 763–64). 

354. Mr. Nealis will often correspond with potential customers to answer any questions 

that they may have about the product and provide them with test reports. (CCX 813 

(Nealis, Dep. at 49; RX 13)). 

355. ECM customers ordinarily test ECM’s product in manufacture, often perform 

biodegradability testing on plastics made with the ECM additive, and evaluate testing 

performed on ECM’s product before deciding to incorporate the product into plastics 

that are sold to downstream purchasers and ultimately made available to consumers. 

(Sinclair, Tr. 761–63; Sullivan, Tr. 704–05). 

356. Most ECM customers put their marketing department to the task of developing 

claims. (Sinclair, Tr. 763). 

357. No customer has ever asked Mr. Nealis to provide a narrower timeframe than some 

period greater than a year. (CCX 813 (Nealis, Dep. at 111)). 

358. No customer has ever asked ECM what some period greater than a year means. 

(CCX 813 (Nealis, Dep. at 112). 
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359. ECM customers are not concerned with the rate of biodegradation; rather, their 

concern is that plastics made with the ECM additive will biodegrade when discarded 

into the environment. (Sinclair, Tr. 774). 

360. ECM has no storefront or brick and mortar office. (Sinclair, Tr. 765–66). 

361. Customers place orders directly with the ECM customer service team, and the 

product is shipped directly from the ECM manufacturing site in Carpentersville, 

Illinois. (Sinclair, Tr. 765). 

362. Prior to processing an order, ECM double-checks that the company understands the 

proper loading rate is one percent (1%) by weight. (Sinclair, Tr. 765). 

363. ECM provides its customers with precise and tailored manufacturing instructions to 

ensure that the product made with the additive is distributed throughout the plastic 

and that the additive is not scorched. (Sinclair, Tr. 762, 783, 787–90). 

364. ECM sells only the MasterBatch Pellet and no other products. (Sinclair, Tr. 766). 

365. Most sales of the ECM additive are completed over the phone and followed-up with a 

confirmation fax or e-mail. (Sinclair, Tr. 766; RX 23). 

366. When Judge Chappell asked Mr. Sinclair “can the product be purchased over the 

internet?” Mr. Sinclair responded, “no.” (Sinclair, Tr. 766). 

367. The ECM website merely provides a standard web inquiry form that is automatically 

emailed to the ECM sales team and Mr. Sinclair. (RX 139). 

368. ECM customers are plastics manufacturers who sell to multiple other, second-layer 

manufacturers. (Sinclair, Tr. 707–08; RX 471). 

369. ECM targets its marketing message to plastic product manufacturers. (Sinclair, Tr. 

787). 

370. ECM-infused plastics often pass through at least two levels in the supply chain before 

ever reaching a so-called “end-user.” (Sinclair, Tr. 785–86; CCX 811 (Hong, Dep. at 

10–11, 112)). 

371. It can be very difficult to determine who the “end-use consumer” is. (Sinclair, Tr. 

786). 

372. ECM doesn’t know and cannot control how its customers label or advertise their 

products. (Sinclair, Tr. 786–87). 
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373. Rarely, an ECM customer will ask Mr. Sinclair what he thinks about their anticipated 

labeling language, and Mr. Sinclair will provide his opinion or feedback. (Sinclair, 

Tr. 787; RX 90; RX 117). 

374. Mr. Sinclair does not know of any ECM customer who believes that ECM plastics 

completely decompose into elements found in nature within one year of customary 

disposal. (Sinclair, Tr. 785). 

375. ECM used to say that its additive would cause plastics to biodegrade in nine months 

to five years. (Sinclair, Tr. 768). 

376. ECM stopped saying that the time frame for biodegradation of plastic containing the 

ECM additive is nine months to five year claim about three years ago. (Sinclair, Tr. 

770, 975-76). 

377. ECM updated its website to include the following explanation: 

The basic concept is that biodegradation is a natural process that 

occurs around the world but at various speeds due to various 

conditions. Plastics with our additives behave like sticks, branches 

or trunks of trees. Due to this fact, we do not guarantee any 

particular time because the time depends on the same factors that 

the biodegradation of woods and most other organic materials on 

earth depend – ambient biota and other environmental conditions. 

Under specific composting conditions with additional accelerants 

sprayed on them, some customers have reported biodegradation in 

as little as a couple of months. Under the more usual, commercial 

composting conditions using high heat processes, a time frame of 

around some period greater than a year is a reasonable expectation. 

(RX 681, at 61) 

378. ECM’s website further explains: “It is not a ‘poof, it’s gone’ system but simply 

makes the plastic product biodegrade as if it were a stick or a branch off a tree rather 

than ‘sticking around’ for hundreds of years.” (RX 681, at 61). 

379. ECM distributors have explained to downstream manufacturers that the time it takes 

for an ECM plastic to fully biodegrade will depend on various factors. (RX 08). 

380. Following the revisions to the Green Guides, ECM dispatched a truthful and nonmisleading email to all of its customers explaining the FTC’s requirements 

concerning biodegradable claims. (RX 35–RX 77). 

381. This email to ECM’s customers stated: 
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If you have evidence that your products with our additives will 

fully biodegrade in one year or less in the environment where it 

will be customarily disposed you may still make an unqualified 

claim of “biodegradable” for those products. But for most of our 

customers’ plastic products with our additives whose customary 

disposal is in a landfill, they will not be able to use that unqualified 

claim. 

(RX 35–RX 77). 

382. This email continued by discussing the benefits of ECM’s product: “Municipal Solid 

Waste that biodegrades slowly but surely over periods from a few years to tens of 

years provides the (sic) [landfill gases] that is captured, processed and sold to the 

public renewable energy or even new chemical source. This is the end-of-life 

scenario that has made plastic products with our additives so ever-increasingly 

popular.” (RX 35–RX 77). 

383. ECM’s customers are sophisticated. (Sinclair, Tr. 904). 

384. Mr. Sinclair often provides potential customers with information and answers their 

questions as well. (RX 93; RX 110; RX 122). 

385. ECM’s customers are primarily companies that manufacture plastic or companies that 

have plastic manufactured for them, and some distributors who sell the additive to 

plastic manufacturers. (Sullivan, Tr. 695–96, Sinclair, Tr. 758–59). 

386. ECM sells an industrial product that is not sold to consumers. (Sullivan, Tr. 696; 

Sinclair, Tr. 759). 

387. The ECM customer is primarily interested in the ECM Additive because it provides a 

cost-effective method to produce a biodegradable product in the modern, 

environmentally friendly market. (Sullivan, Tr. 696). 

388. Most ECM customers are long term, repeat purchasers. (Sullivan, Tr. 705–06). 

389. ECM does not sell to consumers. (Sullivan, Tr. 707). 

390. ECM does not target end-use consumers in advertising, of which it has none, or 

marketing. (Sullivan, Tr. 707). 

391. ECM customers are sophisticated industrial consumers with years of plastics 

manufacturing or distributing experience. (Sullivan, Tr. 709; Barber, Tr. 2029). 

392. ECM customers will often ask sophisticated questions about product performance. 

(RX 13; RX 126–RX 135). 
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393. ECM customers have already designed a product that contains additives for color, 

ultraviolet light, flame retardant, etc., and they conduct significant investigation and 

research before making a change in this process. (Sullivan, Tr. 710). 

394. ECM customers are often much larger companies than ECM. (Sullivan, Tr. 709). 

395. ECM customers are primarily concerned with how their product will perform (i.e. 

maintain its other attributes) after the addition of the ECM additive. (Sullivan, Tr. 

709). 

396. Plastics companies purchase ECM additive in either sixty-five kilogram (65kg) drums 

or five hundred kilogram (500kg) pallet boxes. (Sinclair, Tr. 764–65). 

397. ECM’s customers are sophisticated and knowledgeable. (Sinclair, Tr. 773–74; RX 

132). 

398. Plastics manufacturers must make complex, informed choices about which resins or 

plastics to choose to create the appropriate combination of characteristics for the 

product’s purpose. (Sinclair, Tr. 773–74). 

399. Plastic’s manufacturers must also make decisions about machinery, additives, 

coloring and molds. (Sinclair, Tr. 774). 

400. Plastic manufacturing is a very sophisticated and complex process, and ECM’s 

customers are well versed in the investigative steps necessary to make the right 

decisions. (Sinclair, Tr. 774; RX 131; RX 132). 

401. Most ECM customers perform product performance testing on their finished ECMinfused plastic before ordering product. (Sullivan, Tr. 704; RX 413; RX 412; RX 

108; RX 109; RX 130; RX 132). 

402. ECM also encourages biodegradability testing by its customers if they have concerns 

about their ability to support their intended claims. (Sullivan, Tr. 706). 

403. ECM invites independent testing of its product and usually provides two kilograms of 

MasterBatch Pellets for free to a prospective customer for testing, and beyond that 

will sell quantities for further testing. (Sullivan, Tr. 705). 

404. A prospective customer often performs product testing (including performance 

testing) before deciding whether the Plastic containing the ECM additive is a fit. 

(Sullivan, Tr. 704; RX 130; RX 132). 

405. FP International, an ECM customer, tested its ECM plastic product for 

biodegradability. (Barber, Tr. 2029). 
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406. Eden Laboratories has performed biodegradability testing for ECM customers. (Poth, 

Tr. 1481). 

407. Northeast Laboratories has conducted testing on plastics infused with the ECM 

additive for ECM customers. (Johnson, Tr. 1577). 

408. ECM customers will always perform functionality and qualitative testing comparing 

the ECM plastic with their original product. (Sinclair, Tr. 762–63; RX 31). 

409. Functionality and qualitative tests will determine whether the Plastic containing the 

ECM additive is functioning up to the necessary specifications and there has been no 

specification deterioration. (Sinclair, Tr. 763). 

410. Many ECM customers will also perform biodegradability testing, either by a third 

party laboratory or using in-house methods. (Sinclair, Tr. 763). 

411. Many ECM customers do their own biodegradability testing on the ECM additive. 

(Sinclair, Tr. 772). 

412. Some ECM customers actively review ECM’s competition, and even test competing 

products to determine if ECM is the best fit from a performance and biodegradation 

perspective. (RX 159). 

413. The sales process to purchase the ECM additive is long and involved. (Sinclair, Tr. 

764). 

414. On average, a first-time sale, from initial contact to product purchase of the Plastic 

containing the ECM additive, takes six months to a year, and may sometimes take 

several years. (Sinclair, Tr. 767). 

415. Most of ECM’s customers have in-house counsel and often hire outside counsel. 

(Sinclair, Tr. 771). 

416. Most of ECM’s customers have scientists of varying disciplines working for them. 

(Sinclair, Tr. 772). 

417. Most of ECM’s customers either employ plastics engineers or are owned by a plastic 

engineer. (Sinclair, Tr. 772). 

418. Many ECM customers employ scientists or engineers in charge of product 

development. (Barber, Tr. 2028–29; RX 136). 

419. Even ECM distributors explained to downstream manufacturers that the time it takes 

for an ECM plastic to fully biodegrade will depend on various factors. (RX 08). 
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420. ECM regularly corresponds with customers by email or phone to provide them with 

any information they require. (RX 113, RX 115; RX 117-118; RX 126-129; RX 132-

135). 

421. Both direct customers and down-stream customers regularly inquire about the effect 

that various environmental conditions have on the biodegradability of ECM plastics. 

(RX 127-128; RX 132). 

422. ECM has kept customers informed of research developments within the field of 

biodegradable plastic additives in the landfill environment. (RX 89; RX 118). 

423. ECM customers will often ask sophisticated questions about product performance. 

(RX 13). 

424. Some ECM customers are large enough to have entire regulatory departments. (RX 

97). 

425. ECM customers keep abreast of changes in regulatory requirements and 

certifications. (RX 98; RX 116; RX 119). 

426. ECM customers often inquire into ECM’s choices regarding testing methodology, 

results of tests, and extrapolation of results. (RX 122; RX 132). 

427. BioPVC, an ECM customer, also had biodegradability and ecotoxicology testing done 

on its product. (RX 120; RX 121). 

428. For many ECM customers, deciding whether to test a product for biodegradability is 

just another operational decision. (RX 24). 

429. This often includes providing customers with scientific information and test data. (RX 

88; RX 101; RX 122; RX 136). 

430. Even down-stream customers that do not interact directly with ECM have scientists 

on staff. (RX 102). 

431. The evidence suggests that ECM customers are, in fact, only concerned with 

marketing a “biodegradable” claim and, so, they considered ECM’s statements 

concerning the “rate” of biodegradation only to the extent those claims were 

apparently mandated by regulatory bodies such as the FTC. (Sinclair, Tr. 770–771, 

775; RX 105; RX 107; RX 112–113; RX 117; RX 140; RX 871 (Blood, Dep. at 

193)). 

432. Mr. Sinclair often provides potential customers with information and answers their 

questions as well. (RX 93; RX 110; RX 122). 
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B. Deposition Testimony Confirms that ECM’s Customers are 

Sophisticated Plastic Manufacturers 

433. Robert Ringley is the vice president of BER Plastics, Inc. (CCX 800 (Ringley, Dep. 

at 1)). 

434. BER Plastics purchased the ECM additive between 2009 and 2014. (CCX 800 

(Ringley, Dep. at 12)). 

435. In years 2009 through 2014, BER Plastics had approximately 10 million dollars in 

revenue each year. (CCX 800 (Ringley, Dep. at 12–13)). 

436. BER Plastics first heard of ECM through an article in Plastics Technology, a 

respected trade magazine. (CCX 800 (Ringley, Dep. at 15, 20)). 

437. After seeing the article in Plastics Technology, and after a couple of their customers 

asked them about the Plastic containing the ECM additive, BER Plastics called ECM 

and “had a long conversation with Mr. Sinclair [who] gave [BER Plastics] the 

information [they] were looking for.” (CCX 800 (Ringley, Dep. at 20)). 

438. BER Plastics only purchased the ECM additive after speaking to ECM and getting the 

answers to the questions with which they were most concerned. (CCX 800 (Ringley, 

Dep. at 20)). 

439. BER Plastic read the testing information that ECM supplied to them about the ECM 

additive. (CCX 800 (Ringley, Dep. at 23–24)). 

440. BER Plastic does not sell to any end user. (CCX 800 (Ringley, Dep. at 11)). 

441. All of BER Plastic’s film is sold to converters where it is printed and converted into a 

plastic. (CCX 800 (Ringley, Dep. at 11)). 

442. Converters are the people who place orders for BER Plastic’s film. (CCX 800, 

(Ringley, Dep. at 11)). 

443. BER plastics sold low density polyethylene film to 10 customers. (CCX 800 

(Ringley, Dep. at 10)). 

444. The only information BER Plastics received from ECM that BER Plastics passed on 

to its customers was the certificate of biodegradability given by ECM to BER 

Plastics. (CCX 800 (Ringley, Dep. at 30–32)). 

445. ECM never misled BER Plastics. (CCX 800 (Ringley, Dep. at 35)). 

446. BER Plastics never heard any negative comments about the ECM amended film they 

sold to their customers. (CCX 800 (Ringley, Dep. at 35)). 
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447. Donald Kizer is a supply chain manager for D & W Fine Pack. (CCX 801 (Kizer, 

Dep. at 11–13)). 

448. D & W Fine Pack is a manufacturer of disposable products for the food service 

industry. (CCX 801 (Kizer, Dep. at 12)). 

449. D & W Fine Pack has been in business since 2009. (CCX 801 (Kizer, Dep. at 2)). 

450. Before 2009, D & W Fine Pack was known as Dispoz-o Products. (CCX 801 (Kizer, 

Dep. at 11–12)). 

451. D & W Fine Pack has a 580,000 square foot manufacturing plant. (CCX 801(Kizer, 

Dep. at 14)). 

452. In 2008 Dispoz-o had approximately 83 million dollars in revenue. (CCX 801(Kizer, 

Dep. at 15)). 

453. In 2009 D & W Fine Pack had approximately 120 million dollars in revenue. (CCX 

801 (Kizer, Dep. at 16)). 

454. In 2013 D & W Fine Pack had approximately 424 million dollars in revenue. (CCX 

801 (Kizer, Dep. at 16)). 

455. In 2008, Dispoz-o had 740 employees. (CCX 801 (Kizer, Dep. at 16)). 

456. In 2009, D & W Fine Pack had 1,540 employees. (CCX 801 (Kizer, Dep. at 17)). 

457. D & W Fine Pack hired outside contractors with scientific knowledge. (CCX 801 

(Kizer, Dep. at 18)). 

458. Dispoz-o waited about three or four months from their initial contact with ECM to 

actually make their first purchase of the ECM additive. (CCX 801 (Kizer, Dep. at 22–

23)). 

459. Dispoz-o’s CEO and operations manager were the individuals who decided to 

purchase the ECM additive. (CCX 801 (Kizer, Dep. at 24)). 

460. ECM provided answers to Dispoz-o’s and D & W Fine Pack’s questions concerning 

the properties of the ECM additive. (CCX 801 (Kizer, Dep. at 25)). 

461. Dispoz-o and D & W Fine Pack communicated directly with Bob Sinclair. (CCX 801 

(Kizer, Dep. at 26)). 

462. D & W Fine Pack at one time purchased an additional additive similar to the ECM 

additive, but stopped purchasing the other additive because D & W Fine Pack had 

issues with processing the other additive into their materials. (CCX 801 (Kizer, Dep. 

at 34)). 
 PUBLIC DOCUMENT 

40 

463. For D & W Fine Pack and Dispoz-o, adding the ECM additive into the manufacturing 

process was just like adding a colorant in the manufacturing process. (CCX 801 

(Kizer, Dep. at 35–36)). 

464. Ashley Leiti has been employed by Dispoz-o and D & W Fine Pack since 2008 in the 

fields of marketing, product development, and sales. (CCX 802 (Leiti, Dep. at 14)). 

465. ECM provided to Dispoz-o and D & W Fine Pack testing results, research about the 

ECM additive, and information about the additive. (CCX 802 (Leiti, Dep. at 21)). 

466. ECM provided their certificate of biodegradability to Dispoz-o in 2008. (CCX 802 

(Leiti, Dep. at 22)). 

467. Dispoz-o understood that ECM’s claims meant that products amended with the ECM 

additive were degradable as defined by the ASTM standards. (CCX 802 (Leiti, Dep. 

at 23)). 

468. Dispoz-o and D & W Fine Pack renewed their certificate of biodegradability with 

ECM on annual basis. (CCX 802 (Leiti, Dep. at 24)). 

469. Dispoz-o and D & W Fine Pack believed that ECM’s former nine months to five 

years claim was true because of the totality of information ECM provided to Dispoz-o 

and D & W Fine Pack. (CCX 802 (Leiti, Dep. at 33)). 

470. In August, 2009, D & W Fine Pack stopped making the claim “biodegradable” 

regarding its enviroware line of products containing the ECM additive. (CCX 802 

(Leiti, Dep. at 62; 67-68)). 

471. Dispoz-o and D & W Fine Pack looked to additional sources besides ECM in 

determining whether to rely on the claims made by ECM regarding the ECM additive. 

(CCX 802 (Leiti, Dep. at 66)). 

472. Dispoz-o and D & W Fine Pack asked Robert Sinclair directly questions about 

biodegradability, which Mr. Sinclair answered. (CCX 802 (Leiti, Dep. at 66–67)). 

473. In August 2008, Dispoz-o had a meeting with Robert Sinclair. (CCX 802 (Leiti, Dep. 

at 68)). 

474. ECM, through Robert Sinclair, qualified the nine months to five years biodegradation 

claim to Dispoz-o and D & W Fine Pack. (CCX 802 (Leiti, Dep. at 72–73)). 

475. In August, 2009, D & W Fine Pack stopped making the claim “biodegradable” 

regarding its enviroware line of products containing the ECM additive. (CCX 802 

(Leiti, Dep. at 73)). 

476. ECM gave Dispoz-o and D & W Fine Pack test reports. (CCX 802 (Leiti, Dep. at 91–

92)). 
 PUBLIC DOCUMENT 

41 

477. Dispoz-o and D & W Fine Pack conducted their own testing on ECM amended 

plastics to determine the biodegradability of those plastics. (CCX 802 (Leiti, Dep. at 

95–96)). 

478. Dispoz-o and D & W Fine Pack chose to make their own claims regarding the 

products they sold amended with the ECM additive, regardless of what claims ECM 

made about plastic containing the ECM additive. (CCX 802 (Leiti, Dep. at 135–37)). 

479. Dispoz-o and D & W Fine Pack did not inform ECM that they had received an 

inquiry from the NAD. (CCX 802 (Leiti, Dep. at 148)). 

480. Dispoz-o and D & W Fine Pack has a product development group. (CCX 802 (Leiti, 

Dep. at 155)). 

481. Dispoz-o and D & W Fine Pack takes multiple steps before actually producing a new 

product to sell. (CCX 802 (Leiti, Dep. at 155)). 

482. Dispoz-o and D & W Fine Pack makes samples of a product before selling that 

product. (CCX 802 (Leiti, Dep. at 157)). 

483. Dispoz-o and D & W Fine Pack have three channels of customers: the distribution 

channel, the grocery processor, and the national accounts. (CCX 802 (Leiti, Dep. at 

160)). 

484. All products sold by Dispoz-o and D & W Fine Pack are sold to distributors. (CCX 

802 (Leiti, Dep. at 161)). 

485. All distributors that Dispoz-o and D & W Fine Pack sell products to then sell to 

businesses, such as restaurants. (CCX 802 (Leiti, Dep. at 161)). 

486. An end use consumer of products initially produced by D & W Fine Pack or Dispozdoes not know that the product came from Dispoz-o or D & W Fine Pack. (CCX 802 

(Leiti, Dep. at 161–62)). 

487. Frank Santana is the marketing director for Down to Earth Organic and Natural. 

(CCX 803 (Santana, Dep. at 6, 8)). 

488. Down to Earth Organic and Natural has had five stores since at least 2008. (CCX 

803 (Santana, Dep. at 10)). 

489. Down to Earth Organic and Natural had approximate annual revenue of 30 million 

dollars between 2008 and 2013. (CCX 803 (Santana, Dep. at 10)). 

490. Down to Earth Organic and Natural has employed approximately 200 employees at 

all times since 2008. (CCX 803 (Santana, Dep. at 12–13)). 

491. Down to Earth Organic and Natural first became aware of ECM through word of 

mouth in 2008. (CCX 803 (Santana, Dep. at 19)). 
 PUBLIC DOCUMENT 

42 

492. Down to Earth Organic and Natural reviewed material on the ECM website. (CCX 

803 (Santana, Dep. at 23)). 

493. Down to Earth Organic and Natural was aware that ECM’s certificate of 

biodegradability did not state that ECM amended plastics were biodegradable within 

nine months to five years. (CCX 803 (Santana, Dep. at 32)). 

494. Down to Earth Organic and Natural completed its own evaluation of lab reports to 

determine whether ECM amended plastic was fully biodegradable. (CCX 803 

(Santana, Dep. at 33)). 

495. Down to Earth Organic and Natural reviewed laboratory reports regarding ECM 

amended plastic before purchasing ECM amended plastic. (CCX 803 (Santana, Dep. 

at 34)). 

496. Down to Earth Organic and Natural investigated the ECM technology for the better 

part of a year before deciding to purchase plastic bags amended with the ECM 

additive. (CCX 803 (Santana, Dep. at 38)). 

497. ECM made recommendations to Down to Earth Organic and Natural about how to 

market the ECM amended plastic they provided to customers, but Down to Earth 

Organic and Natural used their judgment and ignored ECM’s recommendations. 

(CCX 803 (Santana, Dep. at 54–55)). 

498. As part of their Earth Day 2009 promotions, Down to Earth Organic and Natural 

offered 30% off on over 50 of their best-selling items. (CCX 803 (Santana, Dep. at 

59)). 

499. Down to Earth Organic and Natural believed that lab reports assessing the 

biodegradability of ECM amended plastics were independent lab reports because of 

the “test in the lab report[s].” (CCX 803 (Santana, Dep. at 66–67)). 

500. On Earth Day 2009, Down to Earth Organic and Natural had more sales than a 

normal day because they had a storewide sale on that day. (CCX 803 (Santana, Dep. 

at 83, 85)). 

501. Down to Earth Organic and Natural purchased ECM amended plastic bags from 

Triple F, who purchased the ECM amended plastic bags from Island Plastic Bags. 

(CCX 803 (Santana, Dep. at 46–47)). 

502. Down to Earth Organic and Natural received criticism from Dr. Ramani Narayan 

regarding the ECM additive, and received a response to Dr. Narayan’s criticism from 

ECM, and Down to Earth Organic and Natural was “satisfied that ECM had 

successfully addressed those criticisms.” (CCX 803 (Santana, Dep. at 91–93)). 

503. Down to Earth Organic and Natural used its own judgment to determine whether the 

McLaren report substantiated ECM’s advertising claims. (CCX 803 (Santana, Dep. at 

96)). 
 PUBLIC DOCUMENT 

43 

504. Island Plastic Bags purchases the ECM additive because it makes plastic 

biodegradable. (CCX 811 (Hong, Dep. at 11)). 

505. Island Plastic Bags’ customers, such as Down to Earth Natural and Organic, simply 

wanted biodegradable products. (CCX 811 (Hong, Dep. at 42, 66, 70–71, 76, 79–81, 

83, 89, 91, 105–08)). 

506. Island Plastics Bags was most concerned with whether the ECM additive could be 

used in their machines, because the additive “doesn’t do [Island Plastic Bags] any 

good if [Island Plastic Bags] can’t use it through [their] machines.” (CCX 811 

(Hong, Dep. at 44)). 

507. Island Plastic Bag’s customers were interested in biodegradable plastic because they 

were interested in sustainability. (CCX 811 (Hong, Dep. at 25)). 

508. There is no evidence that the rate of biodegradation was material to Island Plastic 

Bags when purchasing the ECM additive, so long as the final products were 

biodegradable. (CCX 811 (Hong, Dep. at 1–117)). 

509. There is no evidence that the rate of biodegradation was material to Island Plastic 

Bags’ customers when purchasing the ECM amended plastics from Island Plastic 

Bags, so long as ECM amended plastics would be biodegradable. (CCX 811 (Hong, 

Dep. at 1–117)). 

510. There is no evidence that the rate of biodegradation was relevant to Island Plastic 

Bags when purchasing the ECM additive, so long as the final products were 

biodegradable. (CCX 811 (Hong, Dep. at 1–117)). 

511. There is no evidence that the rate of biodegradation was relevant to Island Plastic 

Bags’ customers when purchasing the ECM amended plastics from Island Plastic 

Bags, so long as ECM amended plastics would be biodegradable. (CCX 811 (Hong, 

Dep. at 1–117)). 

512. George Collins is the President of Eagle Film Extruders, Inc. (CCX 804 (Collins, 

Dep. at 9)). 

513. George Collins has been employed at Eagle Film extruders, Inc. since 2001. (CCX 

804 (Collins, Dep. at 9)). 

514. Eagle Film Extruders, Inc. is a blown film manufacturer of single three layer sheeting. 

(CCX 804 (Collins, Dep. at 10)). 

515. Eagle Film Extruders, Inc. manufacturers only blown film. (CCX 804 (Collins, Dep. 

at 10)). 

516. Eagle Film Extruders, Inc. sells blown film to the markets of food, medical, 

pharmaceutical, health and beauty, coating films, and signage. (CCX 804 (Collins, 

Dep. at 10)). 
 PUBLIC DOCUMENT 

44 

517. Eagle Film Extruders, Inc. purchased the ECM additive beginning in 2008. (CCX 

804 (Collins, Dep. at 11, 16)). 

518. In 2013, Eagle Film Extruders, Inc. had approximately 18 million dollars in sales. 

(CCX 804 (Collins, Dep. at 12)). 

519. After customers inquired about a product, Eagle Film Extruders contacted Robert 

Sinclair and then talked with Mr. Sinclair about the ECM additive before deciding to 

purchase the additive. (CCX 804 (Collins, Dep. at 14–15)). 

520. ECM provided information, including test reports, to Eagle Film Extruders, Inc. 

(CCX 804 (Collins, Dep. at 17)). 

521. When discussing biodegradation of plastic containing the ECM additive with Eagle 

Film Extruders, Inc., Mr. Sinclair did not discuss any specific time frame regarding 

how long it takes ECM amended plastics to biodegrade. (CCX 804 (Collins, Dep. at 

17–18)). 

522. Eagle Film Extruders, Inc. understood that plastic containing the ECM additive could 

take years to biodegrade. (CCX 804 (Collins, Dep. at 18)). 

523. If customers had questions about the ECM additive, Eagle Film Extruders, Inc. 

instructed those customers to talk directly with Bob Sinclair. (CCX 804 (Collins, 

Dep. at 22)). 

524. Eagle Film Extruders, Inc. allows its customers to determine for themselves whether 

the ECM additive works as claimed. (CCX 804 (Collins, Dep. at 33–34, 53–54)). 

525. Eagle Film Extruders, Inc. did not promote blown film containing the ECM additive. 

(CCX 804 (Collins, Dep. at 35)). 

526. Eagle Film Extruders, Inc. represented that ECM amended blown film breaks down in 

15 months. (CCX 804 (Collins, Dep. at 47)). 

527. David Sandry is the corporate representative for Flexible Plastics. (CCX 809 

(Sandry, Dep. at 4)). 

528. Flexible Plastics prints and manufactures plastic bags. (CCX 809 (Sandry, Dep. at 

8)). 

529. Flexible Plastics purchases rolls of plastic from extruders. (CCX 809 (Sandry, Dep. 

at 9)). 

530. Flexible Plastics has used and continues to use the ECM additive in their plastic bags. 

(CCX 809 (Sandry, Dep. at 10)). 

531. Corn based plastics bags were too expensive for Flexible Plastic’s customer to 

purchase. (CCX 809 (Sandry, Dep. at 14–15)). 
 PUBLIC DOCUMENT 

45 

532. Flexible Plastics understood that by adding the ECM additive to their plastic bags, the 

additive would simply break down faster than an untreated bag. (CCX 809 (Sandry, 

Dep. at 17)). 

533. Flexible Plastics never distributed ECM marketing materials to their customers. 

(CCX 809 (Sandry, Dep. at 40)). 

534. There is no evidence that any of Flexible Plastic’s customers marketed any rate claim 

associated with their biodegradable plastic bags. (CCX 809 (Sandry, Dep. at 53)). 

535. Flexible Plastics sells their product all over the country. (CCX 809 (Sandry, Dep. at 

62)). 

536. Flexible Plastics uses high temperatures, 700 to 750 degrees, in order to make plastic 

bags. (CCX 809 (Sandry, Dep. at 63–64)). 

537. Flexible Plastics sells its product 1) through distributors, who sell the product to the 

meat processing industry, 2) to small cities, municipalities, and small trash haulers, 

and 3) through other distributors. (CCX 809 (Sandry, Dep. at 66)). 

538. James Blood is the corporate designee for FP International. (CCX 810 (Blood, Dep. 

at 12–13). 

539. James Blood is the senior vice president and general counsel of FP International. 

(CCX 810 (Blood, Dep. at 214)). 

540. FP International is in the business of manufacturing and selling protective packaging 

products and packaging systems. (CCX 810 (Blood, Dep. at 13)). 

541. FP International’s customers are distributors that distribute and sell to entities that 

ship products in boxes. (CCX 810 (Blood, Dep. at 15)). 

542. FP International began purchasing the ECM additive in 2008. (CCX 810 (Blood, Dep. 

at 13)). 

543. FP International provides a “Biodegradable Packaging Materials: Questions and 

Answers” section on its website. (RX 33). 

544. FP International’s Questions and Answers section explains that the time it takes for a 

product to fully biodegrade depends on environmental conditions, that the product 

will biodegrade in either anaerobic or aerobic conditions, and that the products will 

perform like conventional plastic products. (RX 33). 

545. FP International sold loosefill product and air cushion product amended with the 

ECM additive. (CCX 810 (Blood, Dep. at 17, 22)). 

546. FP International engaged the services of multiple scientists to test the 

biodegradability of their products. (CCX 810 (Blood, Dep. at 57, 87, 163)). 
 PUBLIC DOCUMENT 

46 

547. FP International engaged Stevens Ecology to test the biodegradability of their 

products. (CCX 810 (Blood, Dep. at 57)). 

548. FP International engaged the services of Dr. Timothy Barber of Environ to test the 

biodegradability of their products. CCX 810 (Blood, Dep. at 87)). 

549. FP International engaged the services of Eden Laboratories to test the 

biodegradability of their products. (CCX 810 (Blood, Dep. at 163)) 

550. FP International believes that Environ’s test results demonstrated that plastic 

amended with the ECM additive will biodegrade. (CCX 810 (Blood, Dep. at 119)). 

551. FP International does not state that its products amended with the ECM additive will 

biodegrade in “some period greater than a year.” (CCX 810 (Blood, Dep. at 192)). 

552. FP International decided to transition its prior claims to the claim that ECM amended 

plastic will biodegrade in landfills in one to five years or more independent of any 

communication with ECM. (CCX 810 (Blood, Dep. at 193–94)). 

553. Based on their testing and experience, FP International realized that it was difficult to 

assess the time periods in which ECM amended plastic would biodegrade in landfills. 

(CCX 810 (Blood, Dep. at 194–95)). 

554. FP International met with Robert Sinclair in person before entering into any contract 

with ECM. (CCX 810 (Blood, Dep. at 206)). 

555. Adrian Hong is the corporate designee for Island Plastic Bags. (CCX 811 (Hong, 

Dep. at 9)). 

556. Adrian Hong is the General Manager for Island Plastic Bags. (CCX 811 (Hong, Dep. 

at 110)). 

557. Island Plastic Bags has been in business since 1992. (CCX 811 (Hong, Dep. at 9)). 

558. Island Plastic Bags manufactures and sells high density and low density polyethylene 

bags in various dimensions and gauges. (CCX 811 (Hong, Dep. at 9–10)). 

559. Island Plastic Bags manufactures and sells plastic cutlery. (CCX 811 (Hong, Dep. at 

10)). 

560. Island Plastic Bags sells its products to either distributors or retailers. (CCX 811 

(Hong, Dep. at 11)). 

561. Island Plastic Bags became aware of the ECM additive through discussions with 

different manufacturing partners. (CCX 811 (Hong, Dep. at 11)). 
 PUBLIC DOCUMENT 

47 

562. Island Plastic Bags reviewed the McLaren/Hart Report and came to their own 

conclusions about the biodegradability of plastic amended with the ECM additive. 

(CCX 811 (Hong, Dep. at 32–33, 38–40)). 

563. Island Plastic Bags chose to maintain the nine months to five years claim and not 

transition the claim to greater than a year even after the Green Guides were revised. 

(CCX 811 (Hong, Dep. at 55–56, 61)). 

564. Consumers do not purchase products from Island Plastic Bags. (CCX 811 (Hong, 

Dep. at 77)). 

565. Consumers do not purchase products made by Island Plastic Bags. (CCX 811 (Hong, 

Dep. at 77)). 

566. Island Plastic Bags created their own marketing materials without ECM’s assistance. 

(CCX 811 (Hong, Dep. at 100)). 

567. ECM made itself available to answer Island Plastic Bags’ customers’ questions. 

(CCX 811 (Hong, Dep. at 100)). 

568. Island Plastic Bags had an approximate annual revenue of 6.8 million dollars each 

year from 2008 through 2013. (CCX 811 (Hong, Dep. at 113–14)). 

569. ECM informed Island Plastic Bags that they needed to qualify their claims in light of 

the Green Guides. (CCX 811 (Hong, Dep. at 114)). 

570. Annette Gormly is the vice president of Kappus Plastic Company. (CCX 812 

(Gormly, Dep. at 5)). 

571. Kappus Plastic Company manufactures calendered vinyl rigid sheeting. (CCX 812 

(Gormly, Dep. at 11)). 

572. Kappus Plastic Company produces sheet stock or rolls that it sells to companies. 

(CCX 812 (Gormly, Dep. at 11)). 

573. Most of Kappus Plastic Company’s customers are credit card companies. (CCX 812 

(Gormly, Dep. at 12)). 

574. Kappus Plastic Company has been manufacturing since 1970. (CCX 812 (Gormly, 

Dep. at 12)). 

575. Kappus Plastic Company’s customer’s customers are primarily banks, and some are 

other companies or department stores. (CCX 812 (Gormly, Dep. at 12)). 

576. Kappus Plastic Company purchased the ECM additive from 2009 through 2013. 

(CCX 812 (Gormly, Dep. at 13)). 

577. Kappus Plastic Company has a laboratory. (CCX 812 (Gormly, Dep. at 17–18, 21)). 
 PUBLIC DOCUMENT 

48 

578. Kappus Plastic Company did not provide its ECM Certificate directly to any of its 

customers. (CCX 812 (Gormly, Dep. at 29)). 

579. Kappus Plastic Company is familiar with the ASTM. (CCX 812 (Gormly, Dep. at 

41)). 

580. James Bean is the corporate designee for Quest Plastics, Inc. (CCX 817 (Bean, Dep. 

at 7)). 

581. James Bean is the president and owner of Quest Plastics, Inc. (CCX 817 (Bean, Dep. 

at 11)). 

582. Quest Plastics, Inc. is an injection molding company that makes caps for aerosols, 

fragrances, and cosmetic packaging. (CCX 817 (Bean, Dep. at 9)). 

583. In essence, Quest Plastics, Inc. converts thermoplastic raw material into products such 

as caps, closures, lipstick cases and other custom molding. (CCX 817 (Bean, Dep. at 

10)). 

584. James Bean worked for three years at Harvard Medical School conducting open heart 

surgery on dogs and sheep. (CCX 817 (Bean, Dep. at 16–17)). 

585. Quest Plastics, Inc. has been in business for 24 years. (CCX 817 (Bean, Dep. at 11)). 

586. James Bean worked as a consultant in the plastics industry. (CCX 817 (Bean, Dep. at 

17)). 

587. Quest Plastics, Inc. sells its products primarily to companies in the eyelet industry. 

(CCX 817 (Bean, Dep. at 18)). 

588. All of Quest Plastics, Inc.’s customers are companies. (CCX 817 (Bean, Dep. at 19)). 

589. Quest Plastics, Inc. has facilities that run tests. (CCX 817 (Bean, Dep. at 39)). 

590. Quest Plastics, Inc. does not sell any product directly to consumers. (CCX 817 

(Bean, Dep. at 41)). 

591. Stephen Joseph is 3M Company’s corporate representative. (CCX 821 (Joseph, Dep. 

at 9)). 

592. Stephen Joseph is a senior division scientist at 3M Company. (CCX 821 (Joseph, 

Dep. at 28)). 

593. 3M Company first became aware of the ECM additive by reviewing ECM’s website. 

(CCX 821 (Joseph, Dep. at 31–32)). 

594. 3M Company is not aware of using carbon 14 type testing to evaluate the 

biodegradability of a sample. (CCX 821 (Joseph, Dep. at 67)). 
 PUBLIC DOCUMENT 

49 

595. 3M Company does not rely on third party information with respect to claims 

regarding biodegradation of a polymer. (CCX 821 (Joseph, Dep. at 113)). 

596. Ramy Samuel is the corporate designee for ANS Plastics Corporation. (CCX 822 

(Samuels, Dep. at 7)). 

597. Ramy Samuels is one of the owners and is the vice president of ANS Plastics 

Corporation. (CCX 822 (Samuels, Dep. at 9)). 

598. ANS Plastics Corporation manufactures plastic shopping bags. (CCX 822 (Samuels, 

Dep. at 8)). 

599. ANS Plastics Corporation sells to wholesalers, distributors, and retailers such as 

restaurants, bagel shops, auto part stores, supermarkets, pet stores, and pizza stores. 

(CCX 822 (Samuels, Dep. at 8–9)). 

600. ANS Plastics Corporation has been in business since 1993. (CCX 822 (Samuels, 

Dep. at 9)). 

601. Remy Samuels has been around plastics his entire life. (CCX 822 (Samuels, Dep. at 

11)) 

602. ANS Plastic Corporation’s customers contacted ECM directly. (CCX 822 (Samuels, 

Dep. at 23–24)). 

603. No consumer ever purchased an ECM amended product from ANS Plastic 

Corporation. (CCX 822 (Samuels, Dep. at 26)). 

604. No consumer ever purchased an ECM amended product that was manufactured by 

ANS Plastic Corporation. (CCX 822 (Samuels, Dep. at 26)). 

C. Deposition Testimony Confirms that the Rate of Biodegradation of 

Plastic Containing the ECM Additive is not Material to any of 

ECM’s Customers’ Purchasing Decisions 

605. BER Plastics never really thought about how long it would take an ECM amended 

plastic to biodegrade. ((CCX 800 (Ringley, Dep. at 32)). 

606. BER Plastic’s customers are interested in biodegradable products. (CCX 800 

(Ringley, Dep. at 17)). 

607. BER Plastic’s customers wanted a product that they could call biodegradable. (CCX 

800 (Ringley, Dep. at 17)). 
 PUBLIC DOCUMENT 

50 

608. BER Plastic’s customers wanted a product that they could market as degradable so 

they could say they are being environmentally sensitive. (CCX 800 (Ringley, Dep. at 

18)). 

609. BER Plastic’s customers want to be able to mark biodegradable on packaging because 

they are afraid they might otherwise lose business. (CCX 800 (Ringley, Dep. at 18)). 

610. All of the customers that BER Plastic’s sold ECM amended low density polyethylene 

to make low density polyethylene bags. (CCX 800 (Ringley, Dep. at 19)). 

611. BER Plastics is one of the biggest pillow film producers in the country. (CCX 800 

(Ringley, Dep. at 11)). 

612. No customer of BER Plastics ever complained that the ECM amended film was not 

biodegradable. (CCX 800 (Ringley, Dep. at 35)). 

613. There is no evidence that the rate of biodegradation was relevant to BER Plastics 

when purchasing the ECM additive. (CCX 800 (Ringley, Dep. at 1–36)). 

614. There is no evidence that the rate of biodegradation was relevant to BER Plastics’ 

customers when purchasing the ECM amended film from BER Plastics. (CCX 800 

(Ringley, Dep. at 1–36)). 

615. There is no evidence that the rate of biodegradation was material to BER Plastics 

when purchasing the ECM additive. (CCX 800 (Ringley, Dep. at 1–36)). 

616. There is no evidence that the rate of biodegradation was material to BER Plastics’ 

customers when purchasing the ECM amended film from BER Plastics. (CCX 800 

(Ringley, Dep. at 1–36)). 

617. Dispoz-o’s customers were distributors that distributed products to the food service 

industry, hotel, hospitality, paper houses, and paper industry. (CCX 801 (Kizer, Dep. 

at 13–14)). 

618. Since becoming D & W Fine Pack, the customer base has stayed the same, and D & 

W Fine Pack sells to distributors. (CCX 801(Kizer, Dep. at 14)). 

619. Dispoz-o and D & W Fine Pack purchased an additive from ECM starting in 2008. 

(CCX 801 (Kizer, Dep. at 19)). 

620. Dispoz-o began purchasing the ECM additive because they wanted a “green product 

that [they] could bring to the marketplace.” (CCX 801 (Kizer, Dep. at 19)). 

621. Dispoz-o believed that if they were able to market “a foam tray that had a green story 

behind it that it would be beneficial.” (CCX 801 (Kizer, Dep. at 20)). 

622. By being a “green” product, Dispoz-o wanted something that would be biodegradable 

or compostable. (CCX 801 (Kizer, Dep. at 21)). 
 PUBLIC DOCUMENT 

51 

623. Dispoz-o understood that by adding the ECM additive to their products that they 

would see biodegradation. (CCX 801 (Kizer, Dep. at 22)). 

624. Dispoz-o understood biodegradation to mean that the product “would degrade over a 

period of time.” (CCX 801 (Kizer, Dep. at 22)). 

625. Dispoz-o and D & W Fine Pack purchased the ECM additive so that the company 

could sell a “green” product. (CCX 801 (Kizer, Dep. at 30)). 

626. Dispoz-o and D & W Fine Pack’s customers sold the ECM amended plastics through 

their own chains of distribution with business such as restaurants and hospitality 

being the at the end of the chains of distribution. (CCX 801 (Kizer, Dep. at 31)). 

627. The most prominent marketing claims that Dispoz-o and D & W Fine Pack made 

regarding their enviroware product line, which was amended with the ECM additive 

was that it was “100% biodegradable” and that it was “biodegradable.” (CCX 802 

(Leiti, Dep. at 47, 49–50)). 

628. Mr. Kizer does not know how long Dispoz-o thought an ECM amended product 

would take to biodegrade. (CCX 801 (Kizer, Dep. at 23)). 

629. In May, 2009, D & W Fine Pack stopped making the claim “100% biodegradable” 

regarding its enviroware line of products containing the ECM additive. (CCX 802 

(Leiti, Dep. at 47, 54)). 

630. In August, 2009, D & W Fine Pack stopped making the claim “biodegradable” 

regarding its enviroware line of products containing the ECM additive. (CCX 802 

(Leiti, Dep. at 47, 55)). 

631. By July, 2011, D & W Fine Pack started making the claim “accelerates the 

degradation process” regarding its enviroware line of products containing the ECM 

additive. (CCX 802 (Leiti, Dep. at 47, 55)). 

632. D & W Fine Pack’s customers were concerned with what effects enviroware would 

have on insects in the ground. (CCX 802 (Leiti, Dep. at 61)). 

633. There is no evidence that the rate of biodegradation was relevant to Dispoz-o or D & 

W Fine Pack when purchasing the ECM additive. (CCX 801 (Kizer, Dep. at 1–41); 

CCX 802 (Leiti, Dep. at 1–182)). 

634. There is no evidence that the rate of biodegradation was material Dispoz-o or D & W 

Fine Pack when purchasing the ECM additive. (CCX 801 (Kizer, Dep. at 1–41); CCX 

802 (Leiti, Dep. at 1–182)). 

635. There is no evidence that the rate of biodegradation was relevant to Dispoz-o or D & 

W Fine Pack customers when purchasing the ECM amended film from Dispoz-o or D 

& W Fine Pack. (CCX 801 (Kizer, Dep. at 1–41); CCX 802 (Leiti, Dep. at 1–182)). 
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52 

636. Down to Earth Organic and Natural purchased ECM amended plastic because it 

biodegrades with or without oxygen and because of the price as compared to 

compostable products. (CCX 803 (Santana, Dep. at 39)). 

637. Down to Earth Organic and Natural informed customers that their plastic bags were 

biodegradable because they wanted to inform customers that they were doing their 

part to help the environment. (CCX 803 (Santana, Dep. at 43)). 

638. Down to Earth Organic and Natural thought the ECM amended plastics would further 

their purpose of cherishing the land and living in health and harmony. (CCX 803 

(Santana, Dep. at 45–46)). 

639. Down to Earth Organic and Natural promotes organic farming, sells organic and 

natural products, and promotes an organic and natural lifestyle. (CCX 803 (Santana, 

Dep. at 12)). 

640. Environmental activists challenging Down to Earth Organic’s biodegradability claims 

thought that it was unacceptable for bags to take nine months to five years for a 

plastic bag to break down. (CCX 803 (Santana, Dep. at 99)). 

641. No consumer actually purchased an ECM amended plastic bag from Down to Earth 

Organic and Natural. (CCX 803 (Santana, Dep. at 47–48)). 

642. There is no evidence that the rate of biodegradation was relevant to Down to Earth 

Organic and Natural when purchasing the ECM additive. (CCX 803 (Santana, Dep. at 

1–114)). 

643. There is no evidence that any customer of Down to Earth Organic and Natural 

purchased items from Down to Earth Organic and Natural because Down to Earth 

Organic and Natural provided ECM amended bags. (CCX 803 (Santana, Dep. at 1–

114)). 

644. There is no evidence that the rate of biodegradation of their plastic bags was relevant 

to Down to Earth Organic and Natural customers when purchasing items from Down 

to Earth Organic and Natural. (CCX 803 (Santana, Dep. at 1–114)). 

645. There is no evidence that the rate of biodegradation was material to Down to Earth 

Natural and Organic when purchasing the ECM amended plastic bags. (CCX 803 

(Santana, Dep. at 1–114)). 

646. There is no evidence that the rate of biodegradation of their plastic bags was material 

to Down to Earth Organic and Natural customers when purchasing items from Down 

to Earth Organic and Natural. (CCX 803 (Santana, Dep. at 1–114)). 

647. Eagle Film Extruders, Inc.’s customers wanted blown film amended with the ECM 

additive because they wanted to sell an environmentally-friendly biodegradable 

product. (CCX 804 (Collins, Dep. at 15)). 
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53 

648. Eagle Film Extruders, Inc. sells blown film to converters. (CCX 804 (Collins, Dep. at 

65)). 

649. Eagle Film Extruders, Inc. does not sell to end users. (CCX 804 (Collins, Dep. at 

65)). 

650. “Industry osmosis” is the process of learning things about an industry from being 

immersed in that industry. (CCX 804 (Collins, Dep. at 67–68)). 

651. Eagle Film Extruders, Inc. became aware of ECM through industry osmosis. (CCX 

804 (Collins, Dep. at 30)). 

652. Eagle Film Extruders, Inc. uses a complex process to determine which products to 

sell or not to sell. (CCX 804 (Collins, Dep. at 68–69)). 

653. There is no evidence that the rate of biodegradation was relevant to Eagle Film 

Extruders, Inc. when purchasing the ECM additive. (CCX 804 (Collins, Dep. at 1–

71)). 

654. There is no evidence that the rate of biodegradation was relevant to Eagle Film 

Extruders, Inc.’s customer when purchasing the ECM amended film from Eagle Film 

Extruders, Inc. (CCX 804 (Collins, Dep. at 1–71)). 

655. There is no evidence that the rate of biodegradation was material to Eagle Film 

Extruders, Inc. when purchasing the ECM additive. (CCX 804 (Collins, Dep. at 1–

71)). 

656. There is no evidence that the rate of biodegradation was material to Eagle Film 

Extruders Inc.’s customers when purchasing the ECM amended film from Eagle Film 

Extruders, Inc. (CCX 804 (Collins, Dep. at 1–71)). 

657. Flexible Plastics was interested in the Plastic containing the ECM additive because 

their customers asked for biodegradable or greener bags. (CCX 809 (Sandry, Dep. at 

13–14)). 

658. Flexible Plastic’s customers want to sell a more environmentally friendly plastic bag. 

(CCX 809 (Sandry, Dep. at 15)). 

659. It was important to Flexible Plastics that any additive they added to their bags would 

not dramatically change their pricing. (CCX 809 (Sandry, Dep. at 18)). 

660. When a customer or potential customer asked Flexible Plastics whether they sold 

biodegradable bags, Flexible Plastics referred the customer or potential customer to 

ECM’s website. (CCX 809 (Sandry, Dep. at 30–31, 33)). 

661. Some of Flexible Plastic’s customer simply wanted a biodegradable bag. (CCX 809 

(Sandry, Dep. at 33–34)). 
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662. Flexible Plastics’ customers simply wanted a product that was more environmentally 

friendly than traditional plastic bags. (CCX 809 (Sandry, Dep. at 72–73)). 

663. Flexible Plastics’ customers provided no specific definition of “biodegradable.” 

(CCX 809 (Sandry, Dep. at 73)). 

664. No Flexible Plastics’ customer every said that they needed their products to 

biodegrade in any specific time frame. (CCX 809 (Sandry, Dep. at 74)). 

665. It was important to Flexible Plastics that the ECM additive would cause their plastic 

bags to become biodegradable. (CCX 809 (Sandry, Dep. at 75)). 

666. Flexible Plastics had no definition or time frame in mind regarding the term 

“biodegradable.” (CCX 809 (Sandry, Dep. at 75)). 

667. Medical Arts Press, formerly Flexible Plastics’ second largest customer, ceased 

purchasing from Flexible Plastics in 2013 because of the price of Flexible Plastics’ 

product. (CCX 809 (Sandry, Dep. at 75–77)). 

668. Flexible Plastics relied on representations made by ECM to the extent that Flexible 

Plastics could make a “biodegradable” product. (CCX 809 (Sandry, Dep. at 83)). 

669. On some of the bags Flexible Plastics sold which contained the ECM additive, there 

was no identification at all that those bags contained the ECM additive. (CCX 809 

(Sandry, Dep. at 43–44)). 

670. Some of Flexible Plastic’s customers marketed plastic bags amended with the ECM 

additive as “biodegradable.” (CCX 809 (Sandry, Dep. at 52–53)). 

671. Quality and cost are the most important factors for Flexible Plastics when deciding 

which rolls of plastics to purchase. (CCX 809 (Sandry, Dep. at 69–70)). 

672. By quality, Flexible Plastics means that they want to purchase plastic rolls that work 

best with the products that they are producing with the machines that they are using. 

(CCX 809 (Sandry, Dep. at 70)). 

673. There is no evidence that the rate of biodegradation was relevant to Flexible Plastics 

when purchasing the ECM additive. (CCX 809 (Sandry, Dep. at 1–86)). 

674. There is no evidence that the rate of biodegradation was relevant to Flexible Plastics’ 

customers when purchasing the ECM amended bags from Flexible Plastics (CCX 809 

(Sandry, Dep. at 1–86)). 

675. There is no evidence that the rate of biodegradation was material to Flexible Plastics 

when purchasing the ECM additive. (CCX 809 (Sandry, Dep. at 1–86)). 
 PUBLIC DOCUMENT 

55 

676. There is no evidence that the rate of biodegradation was material to Flexible Plastic’s 

customers when purchasing the ECM amended bags from Flexible Plastics. (CCX 

809 (Sandry, Dep. at 1–86)). 

677. FP International purchases the ECM additive because it allegedly renders plastic 

biodegradable and because the ECM additive helps with FP International’s general 

philosophy of lessening their impact on the environment. (CCX 810 (Blood, Dep. at 

15)). 

678. FP International believed that the biodegradable features of the ECM additive would 

give them a market advantage over competitors. (CCX 810 (Blood, Dep. at 18)). 

679. FP International’s customers wanted a product that would help lessen the impact on 

the environment. (CCX 810 (Blood, Dep. at 19)). 

680. FP International’s customers believed that by using a biodegradable product that they 

were lessening their impact on the environment. (CCX 810 (Blood, Dep. at 28)). 

681. FP International employed a chief scientist, Rod Alire. (CCX 810 (Blood, Dep. at 34, 

57, 104)). 

682. FP International has an engineering department. (CCX 810 (Blood, Dep. at 67)). 

683. FP International relied on testing information and reports provided by ECM, as well 

as background research by their Chief Scientist when making claims that their ECM 

amended products would biodegrade. (CCX 810 (Blood, Dep. at 68–69)). 

684. FP International’s customers do not care how long it takes ECM amended plastic to 

biodegrade, so long as it takes less time than non-amended conventional plastics. 

(CCX 810 (Blood, Dep. at 197)). 

685. FP International’s customers only care that, by purchasing ECM amended plastic as 

opposed to non-amended plastic, that they are lessening their impact on the 

environment. (CCX 810 (Blood, Dep. at 197)). 

686. FP International’s customers define “reasonably short period of time” in the context 

of how long it takes a plastic to biodegrade as faster than typical plastic. (CCX 810 

(Blood, Dep. at 198–99)). 

687. FP International made the claim that its ECM amended products would “decompose 

completely within 9 to 60 months in the presence of microorganisms” because “[i]t 

was important to convey a message of biodegradability.” (CCX 810 (Blood, Dep. at 

25)). 

688. FP International provided its customer with the 9 to 60 month time frame for 

decomposing because they wanted their customers to understand that their products 

would not biodegrade in the same time frame as a compostable product; FP 
 PUBLIC DOCUMENT 

56 

International was “trying to portray that [their product] was not something that is 

going to degrade in a much quicker time frame.” (CCX 810 (Blood, Dep. at 28)). 

689. There is no evidence that the rate of biodegradation was relevant to FP International 

when purchasing the ECM additive, so long as ECM amended plastics would 

biodegrade more quickly than plastic not containing the ECM additive. (CCX 810 

(Blood, Dep. at 1–234)). 

690. There is no evidence that the rate of biodegradation was relevant to FP International’s 

customers when purchasing the ECM amended bags from FP International so long as 

ECM amended plastics would biodegrade more quickly than plastic not containing 

the ECM additive. (CCX 810 (Blood, Dep. at 1–234)). 

691. There is no evidence that the rate of biodegradation was material to FP International 

when purchasing the ECM additive, so long as ECM amended plastics would 

biodegrade more quickly than plastic not containing the ECM additive. (CCX 810 

(Blood, Dep. at 1–234)). 

692. There is no evidence that the rate of biodegradation was material to FP International’s 

customers when purchasing the ECM amended plastics from FP International, so long 

as ECM amended plastics would biodegrade more quickly than plastic not containing 

the ECM additive. (CCX 810 (Blood, Dep. at 1–234)). 

693. Kappus Plastic Company purchased the ECM additive because it makes plastic 

biodegradable. (CCX 812 (Gormly, Dep. at 14)). 

694. Kappus Plastic Company’s customers purchased ECM amended plastic in part 

because it was biodegradable. (CCX 812 (Gormly, Dep. at 15)). 

695. Kappus Plastic Company’s customers were interested in a biodegradable product 

because they were looking for environmentally friendly products. (CCX 812 

(Gormly, Dep. at 15)). 

696. No Kappus Plastic Company products amended with the ECM additive contained any 

sort of biodegradable logo. (CCX 812 (Gormly, Dep. at 22)). 

697. Regarding the biodegradability of their products, Kappus Plastic Company simply 

informed their customers that they were selling a biodegradable product. (CCX 812 

(Gormly, Dep. at 23). 

698. Kappus Plastic Company’s customer asked Kappus Plastic Company whether Kappus 

Plastic Company has a biodegradable product. (CCX 812 (Gormly, Dep. at 46)). 

699. Kappus Plastic Company believes that nine months to five years was not a rigid 

standard for the amount of time it takes ECM amended plastics to biodegrade. (CCX 

812 (Gormly, Dep. at 48–50)). 
 PUBLIC DOCUMENT 

57 

700. There is no evidence that the rate of biodegradation was relevant to Kappus Plastic 

Company when purchasing the ECM additive. (CCX 812 (Gormly, Dep. at 1–53)). 

701. There is no evidence that the rate of biodegradation was relevant to Kappus Plastic 

Company’s customers when purchasing the ECM amended product from Kappus 

Plastic Company. (CCX 812 (Gormly, Dep. at 1–53)). 

702. There is no evidence that the rate of biodegradation was material to Kappus Plastic 

Company when purchasing the ECM additive. (CCX 812 (Gormly, Dep. at 1–53)). 

703. There is no evidence that the rate of biodegradation was material to Kappus Plastic 

Company’s customers when purchasing the ECM amended product from Kappus 

Plastic Company. (CCX 812 (Gormly, Dep. at 1–53)). 

704. Quest Plastics, Inc. purchased the ECM additive on behalf of a customer because that 

customer wanted to produce biodegradable golf tees. (CCX 817 (Bean, Dep. at 19)). 

705. Many of Quest Plastics, Inc.’s customers are not interested in biodegradable products 

because they are concerned with shelf life issues. (CCX 817 (Bean, Dep. at 22–23)). 

706. Quest Plastics, Inc. chose to purchase the ECM additive because it is usable in their 

manufacturing process, was not cost prohibitive, and rendered golf tees 

biodegradable. (CCX 817 (Bean, Dep. at 25–26)). 

707. Quest Plastics, Inc. does not know or care how long it would take the golf tees 

amended with the ECM additive to biodegrade. (CCX 817 (Bean, Dep. at 27)). 

708. 3M Company does not recall whether ECM made any claim regarding the rate at 

which plastic containing the ECM additive biodegrade. (CCX 821 (Joseph, Dep. at 

32)). 

709. 3M Company was interested in the ECM additive because they wanted to research 

whether the additive can help reduce the impact of 3M Company’s products on the 

environment following disposal. (CCX 821 (Joseph, Dep. at 42)). 

710. 3M Company’s customer never told 3M that they needed a biodegradable product to 

meet a specific definition. (CCX 821 (Joseph, Dep. at 126)). 

711. 3M Company was interested in the ECM additive because of the fact that the ECM 

additive could potentially lead to biodegradation of the host plastic while at the same 

time preserving the characteristics of the host plastic. (CCX 821 (Joseph, Dep. at 

112)). 

712. ANS Plastic Corporation’s customers were interested in a biodegradable or “green” 

product. (CCX 822 (Samuels, Dep. at 12–13)). 
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58 

713. ANS Plastic Corporation’s customers were interested in a biodegradable product 

because they “want to be green” and wanted to “call themselves green.” (CCX 822 

(Samuels, Dep. at 13)). 

714. ANS Plastic Corporation marketed plastic products amended with the ECM additive 

simply as biodegradable. (CCX 822 (Samuels, Dep. at 22)). 

715. ANS Plastic Corporation’s customers just give the ECM amended products to 

consumers at no cost. (CCX 822 (Samuels, Dep. at 27)). 

716. ANS Plastic Corporation simply told its customers that they could purchase a 

biodegradable bag. (CCX 822 (Samuels, Dep. at 27–28)). 

717. ANS Plastic Corporation’s customers never asked about the rate of biodegradation for 

ECM amended products. (CCX 822 (Samuels, Dep. at 28)). 

718. ANS Plastic Corporation’s customers only wanted to know whether they were buying 

a biodegradable bag. (CCX 822 (Samuels, Dep. at 28)). 

719. ANS Plastic Corporation’s customers wanted to purchase a biodegradable bag 

because they are environmentally conscious and wanted to use bags that would 

biodegrade. (CCX 822 (Samuels, Dep. at 28)). 

720. There is no evidence that the rate of biodegradation was relevant to ANS Plastic 

Corporation when purchasing the ECM additive. (CCX 822 (Samuels, Dep. at 1–

40)). 

721. There is no evidence that the rate of biodegradation was relevant to ANS Plastic 

Corporation’s customers when purchasing the ECM amended product from ANS 

Plastic Corporation. (CCX 822 (Samuels, Dep. at 1–40)). 

722. There is no evidence that the rate of biodegradation was material to ANS Plastic 

Corporation when purchasing the ECM additive. (CCX 822 (Samuels, Dep. at 1–40)). 

723. There is no evidence that the rate of biodegradation was material to ANS Plastic 

Corporation’s customers when purchasing the ECM amended product from ANS 

Plastic Corporation. (CCX 822 (Samuels, Dep. at 1–40)). 

724. ECM Customers are far more concerned with shelf-life and product durability than 

the time it takes for the product to fully biodegrade. (RX 132). 

725. In fact, customers only request information on the time it takes ECM plastics to fully 

biodegrade in the context of regulatory compliance inquiries. (RX 132-135). 
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59 

D. Deposition Testimony Does Not Help Complaint Counsel Meet Its 

Burden of Proof 

726. No direct customer of ECM testified and no customer of ECM testified at the hearing 

in this case. (Tr. 1–3006). 

727. No consumer of any product manufactured with the ECM additive testified at the 

hearing in this case. (Tr. 1–3006). 

728. No consumer relied on any claim made by ECM when making a purchasing decision. 

(Tr. 1–3006; CCX 0–CCX 1108). 

729. No consumer considers the rate of biodegradation to be material to his or her 

purchasing decision when choosing to buy a product labeled biodegradable as 

opposed to a similar product not labeled biodegradable. (Tr. 1–3006; CCX 0–CCX 

1108). 

730. No consumer relied on any rate claim made by ECM when making a purchasing 

decision. (Tr. 1–3006; CCX 0–CCX 1108). 

731. No consumer suffered a legally cognizable injury as a result of any claim made by 

ECM. (Tr. 1–3006; CCX 0–CCX 1108). 

732. No consumer ever knowingly purchased a Plastic containing the ECM additive. (Tr. 

1–3006; CCX 0–CCX 1108). 

733. No consumer ever purchased a Plastic containing the ECM additive. (Tr. 1–3006; 

CCX 0–CCX 1108). 

734. No consumer ever spent any money on any Plastic containing the ECM additive. (Tr. 

1–3006; CCX 0–CCX 1108). 

735. ECM never communicated directly with any consumer regarding the biodegradability 

features of the ECM additive. (Tr. 1–3006; CCX 0–CCX 1108). 

736. It is not relevant to consumers how long a biodegradable product takes to fully 

biodegrade. (Tr. 1–3006; CCX 0–CCX 1108). 

737. None of ECM’s customers expect ECM amended plastics to completely decompose 

into elements found in nature within one year of customary disposal. (Sinclair, Tr. 

785). 

738. No harm occurs to any consumer even if ECM’s claims are false. (Tr. 1–3006; CCX 

0–CCX 1108). 

739. The vast majority of advertisements and products made by ECM and ECM’s 

customers regarding ECM amended plastics do not mention or focus on rates of 

biodegradation. (RX 00; RX 02; RX 03; RX 14; RX 15; RX 16; RX 17; RX 22; RX 
 PUBLIC DOCUMENT 

60 

26; RX 28; RX 29; RX 30; RX 315; CCX-30 ; CCX-31; CCX 32; CCX 36; CCX 39; 

CCX 43; CCX 46; CCX 47; CCX 49; CCX 50; CCX 52; CCX 59; CCX 60; CCX 63’ 

CCX 64; CCX 65; CCX 66; CCX 79; CCX 97; CCX 98; CCX 99; CCX 100; CCX 

101; CCX 103;CCX 104; CCX 107; CCX 109–CCX 133; CCX 135; CCX 136; CCX 

138; CCX 139; CCX 140; CCX 142–CCX 151). 

V. BACKGROUND ON THE ECM ADDITIVE AND PLASTICS PRODUCED WITH 

THE ECM ADDITIVE 

740. ECM sells a “MasterBatch Pellet” that includes a biodegradable component along 

with an otherwise non-biodegradable (or conventional) plastic carrier resin. (RX 371; 

RX 656; RX 681). 

741. The ECM additive’s formula is a trade secret. (Sinclair, Tr. 777). 

742. ECM chose not to patent the additive because scientists had convinced them that it 

could not be reverse-engineered, and it has yet to be. (Sinclair, Tr. 777–78). 

743. Analytical laboratories attempted to determine the specific ingredients, but none has 

identified the correct formula. (Sinclair, Tr. 777–78; RX 563). 

744. ECM offers a “load rate” of 70% in its pellets, meaning that every pellet will contain 

approximately 70% of the “active” biodegradable formula, along with 30% 

conventional polymer resin. (CCX 818 (Sinclair, Dep. 118–20)). 

745. ECM prescribes that plastics manufacturers blend the pellet into their plastics at a 1% 

rate, resulting in a uniform distribution of the pellet throughout the plastic and at a 

level that ensures maximum utility without compromising the plastic’s integrity. 

(Sinclair, Tr. 765, 775–76, 783, 787–88, 790; CCX 20; RX 137). 

746. Blending of the ECM additive requires no additional equipment from plastics 

manufacturers so long as the manufacturer is already equipped to blend color 

additives. (RX 137). 

747. Through testing and history of use, ECM has established that a 1% load rating in 

finished plastics is required to maintain the additive’s efficacy vis-à-vis 

biodegradation. (Sinclair, Tr. 765, 775–76, 783, 787–88, 790; RX 683; CCX 2). 

748. For all plastics properly manufactured with ECM’s additive, at least 1% of the final 

plastic will include the ECM additive based on weight. (Sinclair, Tr. 783; RX 678). 

749. Like many other plastic additives (e.g., coloring agents), manufacturers introduce the 

ECM additive into the plastic during the initial blending process. (Sinclair, Tr. 797; 

RX 135). 
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61 

750. Plastics are commonly manufactured using one of several techniques, including 

extrusion molding, injection molding, or blow molding. (Sahu, Tr. 1816–17; RX 

656). 

751. Extrusion molding involves a heated plastic compound continuously injected through 

a long die cast in the desired shape. (Sahu, Tr. 1816; RX 783). 

752. There are many different types of plastic polymers, but where ECM additives are 

used, the additive is intended to be mixed uniformly throughout the plastic polymer 

through a heated blending process, just like a coloring additive. (Sahu, Tr. 1813–14; 

RX 520). 

753. ECM’s customers manufacture many plastic polymers, but the bulk of the plastics 

incorporating ECM’s technology consist of polypropylene (PP), polystyrene (PS), 

and polyethylenes (PE). (RX 458; RX 522). 

754. Over seventy (70) percent of ECM plastics are PE plastics. Companies frequently use 

ECM’s technology in plastics such as films (e.g., grocery “t-shirt” bags, packaging 

cushions, etc.). (RX 520; RX 471; RX 849). 

755. In North America, conventional plastics like PE or PP primarily come from domestic 

natural gas and are substances that contain varying formations of hydrocarbon bonds 

or polymers. (RX 458). 

756. A polymer is simply a molecular structure consisting of a string of similar units 

bonded together. (RX 458). 

757. Prior to a potential customer running product samples, ECM will often discuss the 

manufacturing process with the customer ahead of time to determine the most cost 

effective and productive method. (Sinclair, Tr. 762). 

758. Manufacturing some plastics with the ECM additive can require more process 

modifications than others, so ECM works with potential customers to prevent 

scorching and other manufacturing problems. (Sinclair, Tr. 762). 

759. Although the process is involved, most ECM customers can accomplish it quite 

readily. (Sinclair, Tr. 762). 

VI. WHY BIODEGRADATION OF PLASTIC CONTAINING THE ECM ADDITIVE 

MAY NOT OCCUR 

760. There are four primary manufacturing considerations that affect the biodegradability 

of an ECM plastic. (Sinclair, Tr. 787–790). 
 PUBLIC DOCUMENT 

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761. First, polymers that are manufactured at very high temperatures can run the risk of 

scorching the ECM additive. (Sinclair, Tr. 788). 

762. Second, the ECM additive must remain dry because it is hydroscopic and will absorb 

atmospheric moisture. (Sinclair, Tr. 789). 

763. To prevent this, ECM ships its additive in bags with a moisture barrier liner, but 

customers must properly store the additive as well. (Sinclair, Tr. 789). 

764. Third, uniform and complete distribution of the additive throughout every layer of the 

plastic is essential to guarantee biodegradability. (Sinclair, Tr. 788). 

765. Fourth, the load rate of the additive must be at least one percent (1%) by weight. 

(Sinclair, Tr. 787–88). 

766. The failure to adhere to all four elements compromises the biodegradability of the 

plastic. (Sinclair, Tr. 790). 

VII. CONTRARY TO COMPLAINT COUNSEL’S EXTREMELY NARROW 

DEFINITION, THE ONLY SCIENTIFICALLY ACCEPTED DEFINITION OF 

“BIODEGRADABLE” IS BROAD 

767. Complaint Counsel requires that any unqualified biodegradable claim regarding any 

item be supported by competent and reliable scientific evidence “assur[ing] complete 

decomposition within one year and replicat[ing], i.e., simulat[ing], the physical 

conditions found in landfills, where most trash is disposed.” (Complaint, ¶ 4(A)) 

(emphasis added and subtracted). 

768. Complaint Counsel defines a biodegradable item as an “entire item that [will] break 

down into elements found in nature within one year after customary disposal.” 

(Complaint, P. 9; McCarthy, Tr. 484–85; CCX 891 (McCarthy Rep.)). 

769. The FTC’s Green Guides “state that marketers should not make unqualified 

degradable claims for items destined for landfills, incinerators, or recycling facilities 

because complete decomposition in those specific environments will not occur within 

one year.” (RX 347 § IV). 

770. The FTC’s Statement of Basis and Purpose make clear that “[t]he final [Green] 

guides state that an qualified degradable claim for items entering the solid waste 

stream should be substantiated with competent and reliable scientific evidence that 

the entire item will fully decompose within one year after customary disposal.” (RX 

358 § IV(E)(4)).” 
 PUBLIC DOCUMENT 

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771. Complaint Counsel asked Dr. McCarthy to assume, and Dr. McCarthy did assume, 

that “‘biodegradable’ means that the entire treated plastic will completely break down 

and return to nature, decompose into elements found in nature, within one year after 

customary disposal.” (McCarthy, Tr. 681). 

772. The FTC’s Green Guides and the FTC’s Statement of Basis and Purpose cite no 

support in any peer reviewed literature that “degradable” means that a product fully 

decomposes within one year after customary disposal. (RX347; RX 348). 

773. The FTC’s Green Guides and the FTC’s Statement of Basis and Purpose cite no 

support in any peer reviewed literature that the definition of “degradable” includes 

any time limit or time constraint. (RX 347; RX 348). 

774. Scientific literature defines the term “biodegradable” as an on-going process without 

any specific time limit: “the chemical dissolution of materials by bacteria or by other 

biological means.” (G. Gnanavel, V.P. Mohana Jeya Vali, and M. Thirumarimurugan, 

1:3 International Journal of Pharmaceutical and Chemical Sciences 670, 671 (July–

Sept. 2012)). 

775. “Biodegradation takes place by the action of enzymes, chemical degradation with 

living organisms.” (G. Gnanavel, V.P. Mohana Jeya Vali, and M. Thirumarimurugan, 

1:3 International Journal of Pharmaceutical and Chemical Sciences 670, 671 (July–

Sept. 2012)). 

776. Biodegradation has been described as a “two step” process. (G. Gnanavel, V.P. 

Mohana Jeya Vali, and M. Thirumarimurugan, 1:3 International Journal of 

Pharmaceutical and Chemical Sciences 670, 671 (July–Sept. 2012)). 

777. “The first step is the fragmentation of the polymers into lower molecular mass species 

by means of abiotic reactions, like oxidation, photodegradation or hydrolysis, or 

biotic reactions, like degradations by microorganisms.” (G. Gnanavel, V.P. Mohana 

Jeya Vali, and M. Thirumarimurugan, 1:3 International Journal of Pharmaceutical and 

Chemical Sciences 670, 671 (July–Sept. 2012)). 

778. The second step is “the bioassimilation of polymer fragments by the microorganisms 

and their mineralization.” (G. Gnanavel, V.P. Mohana Jeya Vali, and M. 

Thirumarimurugan, 1:3 International Journal of Pharmaceutical and Chemical 

Sciences 670, 671 (July–Sept. 2012)). 

779. Degradation results “from the action of naturally occurring microorganisms such as 

bacteria, fungi, and algae.” (G. Gnanavel, V.P. Mohana Jeya Vali, and M. 

Thirumarimurugan, 1:3 International Journal of Pharmaceutical and Chemical 

Sciences 670, 671 (July–Sept. 2012)). 

780. The Merriam-Webster dictionary defines “biodegradable” as something “capable of 

being slowly destroyed and broken down into very small parts by natural processes, 

bacteria, etc.” or “capable of being broken down especially into innocuous products 

by the action of living things (as microorganisms).” (See "Biodegradable." Merriam-
 PUBLIC DOCUMENT 

64 

Webster.com. Merriam-Webster, n.d. Web. 22 July 2014, available at 

http://www.merriam-webster.com/dictionary/biodegradable) (emphasis added). 

781. Other sources have defined “biodegradable” to mean “capable of being decomposed 

by bacteria or other biological means.” (Collins English Dictionary, 10th Ed. 2009 

(July 22, 2014), available at http://dictionary.reference.com/browse/biodegradation). 

782. Contrary to Complaint Counsel’s and the FTC’s one year restricted definition of 

biodegradation, Dr. Tolaymat testified that “[b]iodegradation is the conversion of 

organic matter through the action of bacteria and fungi into more elementary 

components or elements.” (Tolaymat, Tr. 130). 

783. Dr. Tolaymat’s definition of biodegradation includes no time limit or time constraint. 

(Tolaymat, Tr. 130). 

784. Dr. Tolaymat’s definition of biodegradation—containing no time limit or time 

constraint—conflicts with Dr. McCarthy’s definition in footnote one of McCarthy’s 

report, which requires “that the entire treated plastic will completely break down and 

return to nature (i.e., decompose into elements found in nature) within one year after 

customary disposal (i.e., incinerator, landfill, or recycling). (Tolaymat, Tr. 130; CCX 

891 (McCarthy, Rep. at 5 n. 1)). 

785. Dr. McCarthy has published that “the definition of biodegradable polymer varies 

greatly among scientists, manufacturers, and consumers.” (McCarthy, Tr. 489–490; 

RX 924). 

786. Similarly, Dr. McCarthy testified that “[m]any different definitions [of 

biodegradation] have officially been adopted, depending on the background of the 

defining standard organizations and their particular interests.” (McCarthy, Tr. 527–

528; RX 925). 

787. Dr. McCarthy’s own writings, outside of this litigation, that define biodegradation do 

not include the qualifier that an item must completely breakdown within a period of 

one year. (Sahu, Tr. 1783, 1785). 

788. Contrary to Complaint Counsel’s and the FTC’s time restricted definition of 

biodegradation, Dr. Michel testified that “Biodegradation is the mineralization of 

materials as a result of the action of naturally-occurring microorganisms such as 

bacteria and fungi.” (Michel, Tr. 2907–08; CCX 880). 

789. Dr. Michel’s definition of biodegradation—containing no time limit or time 

constraint—conflicts with Dr. McCarthy’s definition in footnote one of McCarthy’s 

report, which requires “that the entire treated plastic will completely break down and 

return to nature (i.e., decompose into elements found in nature) within one year after 

customary disposal (i.e., incinerator, landfill, or recycling). (Michel, Tr. 2907–08; 

CCX 880; CCX 891 (McCarthy, Rep. at 5 n. 1)). 
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790. The common scientific definition of biodegradation is degradation by biological 

means. (Sahu, Tr. 1782). 

791. “[B]iodgradation means different things to different researchers ... or in different 

contexts.” (Sahu, Tr. 1760). 

792. Biodegradation is a process by which microbial organisms sustain their life by eating 

and metabolizing a material. (Barber, Tr. 2069). 

793. “[F]rom a microbiological standpoint [biodegradation] really is [] the conversion of 

... one substance to another substance as the result of biological activity.” (Burnette, 

Tr. 2375). 

794. “[I]n all contexts [biodegradation] simply means the breakdown of whatever is the 

object of interest using biological means, using essentially biota such as bacteria or 

fungi or other type of naturally occurring or evolving biota in the environment.” 

(Sahu, Tr. 1760). 

795. The ASTM defines biodegradation, as related to plastic products, as the process by 

which natural biota decompose a plastic product into different chemical materials. 

(Sinclair, Tr. 782). 

796. The ASTM has never defined biodegradation as the test plastic completely breaking 

down into elements found in nature within one year of customary disposal. (Sinclair, 

Tr. 782). 

797. The plastics industry has never adopted a definition of biodegradation that requires a 

plastic product to completely decompose and break down into elements found in 

nature within one year after customary disposal in a landfill. (Sinclair, Tr. 782–83). 

798. The scientific literature defining biodegradation does not contain a time restraint. 

(Sahu, Tr. 1783). 

799. No peer reviewed literature defines “biodegradation” to be limited to a “complete 

breakdown of plastics into elements found in nature within one year after customary 

disposal.” (Barlaz, Tr. 2281). 

800. No scientist has published a peer reviewed article defining biodegradation to be 

limited to the “complete breakdown of a plastic or material into elements found in 

nature within one year after customary disposal.” (Burnette, Tr. 2376). 

801. Dr. Tolaymat understands that anaerobic biodegradation occurs at a slower rate than 

aerobic biodegradation. (Tolaymat, Tr. 130). 

802. According to Dr. Tolaymat, “[a]erobic biodegradation is the process of decomposing 

organic matter in the presence of oxygen.” (Tolaymat, Tr. 127). 
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803. According to Dr. Tolaymat, “[a]naerobic biodegrading is the process of decomposing 

organic matter without the presence of oxygen.” (Tolaymat, Tr. 130). 

804. Even the most easily biodegradable substances, such as food waste, will not 

biodegrade in a MSW landfill within one year after customary disposal. (RX 853 

(Barlaz, Rep. at 11); CCX 893 (Tolaymat, Rep. at 16)). 

805. Not even tree trunks, orange peels, or banana peels, all generally accepted to be 

biodegradable in the environment, can reliably break down into elements found in 

nature within one year after customary disposal. (McCarthy, Tr. 503, 506, 508–09, 

RX 841 (McCarthy, Dep. at 187)). 

806. Outside of this litigation, Drs. McCarthy, Tolaymat, and Michel have never defined 

biodegradation to be the complete breakdown of an item into elements found in 

nature within one year after customary disposal. (Michel, Tr. 2908; McCarthy, Tr. 

488; see generally Tolaymat, Tr.). 

807. There is no evidence that, outside the context of this litigation, any one of Drs. 

McCarthy, Tolaymat, and Michel have ever defined biodegradable to be limited by 

any time or rate restriction. (See generally McCarthy, Tr; Tolaymat, Tr; Michel, Tr.). 

808. Biodegradability is a process. (Barber, Tr. 2069). 

809. Whether a material is “biodegradable” means whether biological organisms, 

microbial organisms, can sustain their life functions and eat and metabolize the 

material. (Barber, Tr. 2069). 

810. Some standards have been put in place by various organizations that attempt to define 

a time span for this process, but biodegradation is not subject to a time span limitation 

because it is an ongoing process. (Barber, Tr. 2069). 

811. The ASTM definition of “degradable plastics” is a plastic that will break down into 

different chemical materials. (Sinclair, Tr. 782). 

812. The ASTM definition of “biodegradable plastics” is a plastic which breaks down by 

natural biota. (Sinclair, Tr. 782). 

813. The ASTM definition of “biodegradation” contains no requirement that the test 

plastic completely break down into elements found in nature within one year of 

customary disposal. (Sinclair, Tr. 782). 

814. The biodegradable plastics industry has never adopted a definition of 

“biodegradation” that the test plastic completely break down into elements found in 

nature within one year of customary disposal. (Sinclair, Tr. 782–83). 

815. In 16 CFR § 260.8(c), codifying FTC guidance language, FTC prevents marketers 

from marketing their products as degradable “if the items do not completely 

decompose within one year after customary disposal.” (RX 347). 
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816. In 16 CFR 260.7(b), codifying FTC guidance language, FTC allows marketers to 

market their products as compostable if the marketer has “competent and reliable 

scientific evidence that all the materials in the item will break down into, or otherwise 

become part of usable compost in a safe and timely manner in an appropriate 

composting facility, or in a home compost pile or device.” (RX 347). 

817. Thus, the definition of biodegradable includes a year time limit and a complete 

degradation component, while the definition of compostable includes no time limit. 

(RX 347). 

A. THE GREEN GUIDES’ DEFINITION OF BIODEGRADABLE IS 

INAPPOSITE IN THIS CASE 

A. Both Dr. Stewart and Dr. Frederick Agree that the APCO and 

Synovate Surveys are Flawed and Insufficient to Support the One 

Year Rule 

818. Complaint Counsel and FTC’s definition of biodegradation as requiring the complete 

decomposition of a material into elements found in nature within one year after 

customary disposal is referenced in an agency guidance in the Green Guides and in 

the Green Guides’ Statement of Basis and Purpose. (RX 347; RX 348). 

819. The Green Guides state that “[i]t is deceptive to make an unqualified degradable 

claim for items entering the solid waste stream if the items do not completely 

decompose within one year after customary disposal.” (RX 347, at § 260.8). 

820. The FTC Commission cites two consumer perception surveys to support the one year 

rule. (RX 347, at § IV(E)(4)(A)). 

821. These were the only two consumer perception surveys available to the FTC regarding 

consumer perception of biodegradability at the time the FTC issued its guidance 

definition of biodegradable to mean that the product must completely decompose into 

elements found in nature within one year after customary disposal. (Stewart, Tr. 

2511). 

822. The first survey cited by the Commission is a survey done by APCO Insight, wherein 

60 percent of respondents purportedly expected that an item marked as degradable 

without qualification will fully decompose in less than one year. (RX 347, at § 

IV(E)(4)(A)). 

823. The second survey cited by the Commission in drafting the one year rule was 

conducted by Synovate, wherein 25 percent of respondents expected that an item 

marked as degradable without qualification will fully decompose in less than one 

year. (RX 347, at § IV(E)(4)(A)). 
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824. The APCO survey found that: 

 “Americans are slightly more likely to say the terms biodegradable and 

compostable mean something different rather than the same.” 

 48% of those surveyed thought that the terms meant something different, 

while 40% thought they meant the same. 

 The leading perceived similarity between both terms was that both 

decompose and are not harmful to the environment. 

 Those surveyed believed that compostable materials will break down in 

three months to a year, while biodegradable materials are expected to 

break down in one to two years. 

 Most adults believe that compostable materials are natural (leaves, trigs, 

etc.) while biodegradable materials are manmade (synthetics). 

 Most adults believe that biodegradable materials will completely 

disappear whereas compostable materials turn into soil or fertilizer. 

 Both compostable and biodegradable packaging “are seen as likely to 

reduce landfill burdens, pollution, and even the amount of litter in the 

environment.” 

 Americans are uneducated about both compostable material and 

biodegradable material, and an education component associated with the 

rollout of the packaging is needed. 

 Educated individuals (college graduates) are more understanding of 

longer natural decomposition times. 

(RX 596). 

825. The Synovate study found that: 

 “Of all the venues in which respondents were asked where products 

labeled biodegradable would decompose, ‘landfills’ received the highest 

score (72%) followed by ‘open environment’ (51%) and ‘commercial 

composting’ (51%).” 

 23% of respondents attributed the difference between biodegradation in 

landfills and biodegradation in composting environments to “duration of 

degradation.” 

 “Of those who mentioned factors related to the duration of degradation, 

the majority said landfills take longer to biodegrade.” 
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 72% of respondents believe that traditional plastics will not biodegrade 

on their own. 

 84% of respondents believe biodegradable plastic products will be 

beneficial to landfills. 

 25% of respondents believed plastics should biodegrade in less than one 

year. 

 70% of respondents believed that a biodegradation window of 5 years or 

less for plastics was appropriate. 

 93% of respondents believe it is ok to label a package “biodegradable” if 

it decomposes in a landfill. 

 38% of respondents claimed they often or always check for green aspects 

on a product label. 

 62% of respondents stated they are willing to pay a higher price for 

products that are less burdensome on the environment. 

(RX 673). 

826. Both Dr. Stewart and Dr. Frederick believe the APCO and Synovate studies are 

flawed. (Frederick, Tr. 1045, 1049-51; Stewart, Tr. 2513–17; RX 856 (Stewart Rep. 

at 5-9)). 

827. A close ended question is one in which “there was a list of possible responses that 

were presented to the respondent, and the respondent needed to choose from one of 

the responses that was presented in order to give an answer.” (Stewart, Tr. 2513). 

828. As part of his work in this case, Complaint Counsel’s survey expert Dr. Frederick 

reviewed both the APCO and Synovate surveys. (Frederick, Tr. 1036). 

829. APCO stands for American Plastics Council. (Frederick, Tr. 1036). 

830. The APCO survey was a telephone survey with 1003 responses. (Frederick, Tr. 

1036). 

831. According to Dr. Frederick, the validity of a survey refers to how accurately the 

survey measured what it intended to measure. (Frederick, Tr. 1042; CCX 890 

(Frederick, Rep. at 8)). 

832. According to Dr. Frederick’s testimony, the APCO is not valid; however, in his 

expert report, Dr. Frederick concludes that the APCO survey is valid. (Frederick, Tr. 

1042; CCX 890 (Frederick, Rep. at 8-9)). 
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833. Question four of the APCO study asked respondents “[i]f a package is labeled 

‘biodegradable,’ what should be the maximum amount of time that it should take for 

that package to decompose?” (RX 597, P. 2). 

834. Question four of the APCO survey was closed-ended. (RX 597, at P. 2). 

835. Question four of the APCO survey provided respondents with 6 substantive answer 

options: “One month or less,” “Three months,” “six months,” “one year,” “two to 

four years,” “Five years or more.” (RX 597, at P. 2). 

836. According to Dr. Frederick, the biggest problem with question four of the APCO 

survey “is the allocation of response options.” (Frederick, Tr. 1045). 

837. According to Dr. Frederick, the response options in question four of the APCO 

survey, with four of the six response options being one year or less, carry the “strong 

suggestion that the experimenter expects these are the responses that people are going 

to give ... causing people to give those responses in greater numbers than they would 

if the question used a different design.” (Frederick, Tr. 1045). 

838. Another problem with APCO Survey Question four, according to Dr. Frederick, is 

that it used the word “should” instead of “would.” (Frederick, Tr. 1142). 

839. According to Dr. Frederick, the Synovate study is reliable but invalid. (Frederick, Tr. 

1048–51). 

840. Question 19 of the Synovate survey asked respondents, “[w]hat do you believe is a 

reasonable amount of time for a biodegradable plastic package to decompose in a 

landfill?” (Frederick, Tr. 1048). 

841. According to Dr. Frederick, Synovate survey question 19 uses the word “reasonable,” 

meaning that the interviewer is asking the respondent what he or she “would like to 

happen, what kind of product should be produced.” (Frederick, Tr. 1050). 

842. Another flaw, according to Dr. Frederick, in Synovate survey question 19 is that it is 

a close ended question. (Frederick, Tr. 1049–1051, 1276–77, 1280). 

843. According to Dr. Frederick, it happens “a fair bit” that a survey is reliable but not 

valid. (Frederick, Tr. 1041). 

844. According to Dr. Frederick, a close ended question asking respondents to define 

“love” cannot afford the respondents the full opportunity to explain what they 

understand love to mean. (Frederick, Tr. 1273). 

845. According to Dr. Frederick, it is difficult for a person to offer a response to a question 

when that person does not understand a verb in the question being asked, for example, 

when the respondent does not understand “biodegradable,” in the question “how 

much time will it take to biodegrade.” (Frederick, Tr., 1276). 
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846. Dr. Frederick faults both the APCO and Synovate surveys for having closed-ended 

rather than open-ended questions. (Frederick, Tr. 1280). 

847. Dr. Stewart reviewed both the APCO and Synovate surveys. (Stewart, Tr. 2512). 

848. The use of close ended questions in the APCO survey was premature given the state 

of knowledge of consumers’ understanding of biodegradability. (Stewart, Tr. 

2513-14). 

849. To use closed-ended questions in a meaningful way requires a deep understanding of 

all the potential responses that an individual might give. (Stewart, Tr. 2513). 

850. The response options to APCO survey question four were not balanced. (Stewart, Tr. 

2513). 

851. Two-thirds of the options that were offered to respondents in APCO question four 

were one year or less, which predisposes people to select a shorter time frame rather 

than a longer time frame. (Stewart, Tr. 2513). 

852. The APCO survey, with respect to the question of how long would it take for 

something to biodegrade, is not valid. (Stewart, Tr. 2514). 

853. The APCO survey is invalid because it does not provide adequate opportunity for 

consumers to offer their perceptions of how long it would take for something to 

biodegrade. (Stewart, Tr. 2514). 

854. APCO survey question four is inherently biased because it offers many more 

opportunities to select an answer that reflects one year or less than a longer time 

period. (Stewart, Tr. 2514–15). 

855. Conclusions about people’s perceptions of the length of time that biodegradation 

should require cannot be drawn from the APCO survey. (Stewart, Tr. 2515). 

856. The Synovate survey is flawed because it uses closed-ended questions when asking 

about the length of time that biodegradation should occur. (Stewart, Tr. 2515). 

857. Given the current understanding and state of knowledge with respect to consumer 

perception of biodegradation, open-ended questions are “much more suitable, much 

more appropriate, much more informative, than closed-ended questions.” (Stewart, 

Tr. 2516). 

858. Numerous problems arise when using closed-ended questions to determine the 

percentage of the population that share the same beliefs. (Stewart, Tr. 2516–17). 

859. One problem with using closed-ended questions is that the limited possible answer 

choices will preclude respondents from giving an accurate answer that reflects their 

real perceptions. (Stewart, Tr. 2517). 
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860. One reason surveyors need to do more work involving open-ended questions and 

interviews early in the exploration of a topic like biodegradation is so that surveyors 

can be sure that when they do finally do design close-ended questions, that they have 

given people the full array of response options. (Stewart, Tr. 2517). 

861. “’[M]isleading homogeneity’ is simply a situation in which one characterizes a 

sample or a population as being more alike, more similar, more homogenous than is 

actually the case.” (Stewart, Tr. 2518). 

862. One good example of misleading homogeneity is that in the 1950s it looked like 

Americans were very homogenous with respect to their preferences for media; 

however that false appearance of homogeneity, i.e. misleading homogeneity, occurred 

only because Americans had only three channels to choose from when watching 

television. (Stewart, Tr. 2518–19). 

863. APCO survey question four created a sense of far greater homogeneity than actually 

exists. (Stewart, Tr. 2519). 

864. Misleading homogeneity also exists in the Synovate survey. (Stewart, Tr. 2520). 

865. Both the APCO and Synovate surveys have “serious limitations.” (Stewart, Tr. 

2593). 

866. The Green Guides criticize the APCO and Synovate surveys in a manner similar to 

Dr. Stewart. (Stewart, Tr. 2593–94). 

867. The APCO study uses close-ended questions, which are unhelpful and misleading 

when there are many possible answers among respondents. (Stewart, Tr. 2512–13; 

RX 856 (Stewart Rep. at 7); RX-858 (Frederick, Dep. at 35–36, 165)). 

868. When beginning consumer perception work in a new area, open-ended questions are 

essential. (Stewart, Tr. 2509–10, 2516–18; RX 856 (Stewart, Rep. at 7)). 

869. Close-ended questions inherently suggest greater homogeneity within a sample of 

respondents than may actually exist because close-ended questions exist in a universe 

with only four or five possible responses. (Stewart, Tr. 2516–17; RX 856 (Stewart, 

Rep. at 7)) 

870. An example of misleading homogeneity is found in the APCO survey question 

regarding how long it should take for something to decompose if it is labeled 

biodegradable. (Stewart, Tr. 2514, 2519; RX 856 (Stewart, Rep. at 7)). 

871. In question four of the APCO survey, four of the six response options are a year or 

less, and Drs. Frederick and Stewart concluded that it is not surprising that 60% of the 

respondents selected an answer of one year or less. (Frederick, Tr. 1045; RX 856 

(Stewart, Rep. at 7–8)). 
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872. In fact, a random selection of answers by respondents to question four of the APCO 

survey would yield 66% of responses within the “year or less” category. (RX 856 

(Stewart, Rep. at 7–8); RX-597, at 2). 

873. Dr. Frederick disagrees with the statement in the FTC’s Green Guides Statement of 

Basis and Purpose that “[t]he Synovate study results suggest that respondents’ 

answers may have been not only biased but also influenced by a tendency to avoid 

extreme answers.” (RX 348 at IV(E)(4)(a); RX-858 (Frederick, Dep. at 155–56)). 

874. Dr. Frederick disagrees with the statement in the FTC’s Green Guides Statement of 

Basis and Purpose that “[r]eliable real word conclusions cannot be drawn from the 

Synovate study.” (RX 348 at IV(E)(4)(a); RX-858 (Frederick, Dep. at 157–58)). 

875. Dr. Frederick has criticisms for both the APCO and Synovate surveys. (Frederick, 

Tr. 1270). 

876. Dr. Frederick believes that the APCO study has the potential to introduce bias 

because of the way in which response options were presented and because of the use 

of the word “should.” (Frederick, Tr. 1270). 

877. Dr. Stewart and Dr. Frederick both agree that the APCO survey is flawed with respect 

to the response options provided to respondents. (Stewart, Tr. 2618). 

B. Complaint Counsel’s Survey is Incompetent and Unreliable, and 

Should be Disregarded 

878. Dr. Frederick is not an expert in the standards that apply to the evaluation of survey 

evidence in federal administrative proceedings. (Frederick, Tr. 1185). 

879. Dr. Frederick is not familiar with the standards used to determine qualifications of 

survey experts to testify in federal court. (Frederick, Tr. 1185). 

880. Dr. Frederick is not familiar with the standards that are used to determine the 

qualifications of survey evidence in proceedings before the Federal Trade 

Commission. (Frederick, Tr. 1185) 

881. Dr. Frederick is not familiar with the Reference Manual on Scientific Evidence, Third 

Edition. (Frederick, Tr. 1187). 

882. Dr. Frederick is not familiar with the Manual on Complex Litigation, Fourth Edition. 

(Frederick, Tr. 1187). 

883. Dr. Frederick knows of no specific criteria that are required to be present in a survey 

in order for a survey to be valid. (Frederick, Tr. 1190). 
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884. Dr. Frederick is not familiar with the concept of “disruptive questioning.” (Frederick, 

Tr. 1190). 

885. Complaint Counsel drafted sections of Dr. Frederick’s expert report. (Frederick, Tr. 

1191–92). 

886. Dr. Frederick did not draft the table of contents to his expert report. (Frederick, Tr. 

1191). 

887. Dr. Frederick did not draft paragraphs 6, 7, 9, 10, 12 and part of paragraph 13 of his 

expert report. (Frederick, Tr. 1194–95). 

888. Dr. Frederick believes that Complaint Counsel drafted the table of contents, and 

paragraphs 6, 7, 9, 10, and 12 and part of paragraph 13 of his expert report. 

(Frederick, Tr. 1194–95). 

889. Complaint Counsel drafted three of the four references on page seven of Dr. 

Frederick’s expert report, namely the Google Consumer Surveys Product Overview 

reference, the Google Incorporated, et al. reference, and the Nate Silver reference. 

(Frederick, Tr. 1195). 

890. Dr. Frederick did not draft footnotes two and three on page seven of his expert report. 

(Frederick, Tr. 1196). 

891. Dr. Frederick did not draft footnote 6 on page 11 of his expert report. (Frederick, Tr. 

1196). 

892. Dr. Frederick did not draft, and Complaint Counsel drafted footnotes 8 and 10 and the 

parenthetical which reads “besting better-known rivals such as Gallup, CNN, and 

Rasmussen,” on page 12 of Dr. Frederick’s expert report. (Frederick, Tr. 1196). 

893. Complaint Counsel also drafted the reference to Nate Silver’s blog on page 12 of Dr. 

Frederick‘s expert report. (Frederick, Tr. 1196). 

894. Before seeing the draft of his expert report after Complaint Counsel revised it, Dr. 

Frederick was not aware of any of the content that Complaint Counsel added to his 

expert report. (Frederick, Tr. 1195–96). 

895. The only surveys Dr. Frederick conducted in this proceeding were Google Consumer 

Surveys. (Frederick, Tr. 1196). 

896. Dr. Frederick knew of but failed to perform an internet panel survey for this 

proceeding. (Frederick, Tr. 1197). 

897. Dr. Frederick knew of but failed to perform an in person interview for this 

proceeding. (Frederick, Tr. 1197). 
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898. Dr. Frederick knew of but failed to perform an e-mail survey for this proceeding. 

(Frederick, Tr. 1197). 

899. The FTC paid Dr. Frederick a flat fee of $40,000 to be a witness in this case. 

(Frederick, Tr. 1201). 

900. The less Dr. Frederick had to pay for a survey, on assistants, and on costs, the more 

money he would net as pay for his work in this case. (Frederick, Tr. 1201). 

901. In total, Dr. Frederick’s Google Consumer Surveys cost an estimated $2,000.00. 

(Frederick, Tr. 1203). 

902. Of the $40,000.00 the FTC paid to Dr. Frederick, Dr. Frederick profited 

approximately $32,010.00. (Frederick, Tr. 1203). 

903. Two important reasons why Dr. Frederick chose to use Google Consumer Surveys for 

his work in this case as opposed to other survey methodologies are because of the low 

costs of conducting a Google Consumer Survey and because of his familiarity with 

Google Consumer Survey. (Frederick, Tr. 1206). 

904. The purpose of Dr. Frederick’s Google Consumer Survey was an effort to 

demonstrate that despite its flaws, the APCO survey produced valid and reliable 

results. (Stewart, Tr. 2616; RX 856 (Stewart, Rep at 8 n. 4)). 

905. The purpose of Dr. Frederick’s Google Consumer Survey was not intended to be an 

objective analysis of what people believe about biodegradability. (Stewart, Tr. 2616; 

RX 856 (Stewart, Rep at 8 n. 4)). 

906. Dr. Frederick conducted survey research for this litigation using Google Consumer 

Surveys. (Frederick, Tr. 1060). 

907. No single person was ever presented with more than one question in Dr. Frederick’s 

Google Consumer Surveys. (Frederick, Tr. 1224). 

908. Dr. Frederick’s Google Consumer Surveys did not contain any screening questions. 

(Frederick, Tr. 1224–25). 

909. Dr. Frederick could have, but did not ask any questions to help eliminate those 

respondents who may have been completely ignorant of the subject of plastics 

biodegradation or entirely uninterested in participating in his Google Consumer 

Surveys. (Frederick, Tr. 1227–28). 

910. Dr. Frederick did not provide to any of the respondents any definitions of terms in his 

Google Consumer Survey questions. (Frederick, Tr. 1228). 

911. The survey research Dr. Frederick performed for this litigation cannot be 

characterized as a survey. (Stewart, Tr. 2596). 
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912. Dr. Frederick’s Google Consumer Surveys do not meet the typical definitions of a 

survey as would be used in the marketing and survey profession. (Stewart, Tr. 2596). 

913. Dr. Frederick did not follow the principles for survey research explained in the 

Manual for Complex Litigation, Fourth Edition in conducting his Google Consumer 

Surveys. (Stewart, Tr. 2596–97). 

914. Dr. Frederick did not follow the Standards for Scientific Evidence, Third Edition in 

conducting his Google Consumer Surveys. (Stewart, Tr. 2597). 

915. Dr. Frederick’s Google Consumer Survey does not meet generally accepted standards 

for survey research. (Stewart, Tr. 2598; RX 856 (Stewart, Rep. at 10)). 

916. There are seven characteristics of acceptable survey research: 1) the population was 

properly chosen and defined; 2) the sample chosen was representative of that 

population 3) the data gathered were accurately reported; 4) the data were analyzed in 

accordance with accepted statistical principles; 5) the questions asked were clear and 

not leading; 6) the survey was conducted by qualified persons following proper 

interview procedures; and 7) the process was conducted so as to ensure objectivity 

(the study was double blind). (Stewart, Tr. 2599; RX 856 (Stewart, Rep. at 10)). 

917. Dr. Frederick’s Google Consumer Survey fails to satisfy most of the seven 

characteristics of acceptable survey research. (Stewart, Tr. 2599-2604). 

918. Dr. Frederick’s Google Consumer Survey failed to properly choose and define a 

population because it is not clear what the population was that he was analyzing; 

while it appears to be some subset of the American population, it’s not defined by an 

age and there is no lower bound. (Stewart, Tr. 2600). 

919. Dr. Frederick’s Google Consumer Survey is defined in terms of who participated in 

the survey, which is not an appropriate way to define a population. (Stewart, Tr. 

2600). 

920. Dr. Frederick collected no demographic information from his respondents. (Stewart, 

Tr. 2600). 

921. Dr. Frederick’s Google Consumer Survey failed to implement a sample that was 

representative of the population. (Stewart, Tr. 2600). 

922. There is no way to know whether Dr. Frederick’s population was representative or 

not. (Stewart, Tr. 2600). 

923. Dr. Frederick failed to gather and accurately report the data obtained in his Google 

Consumer Survey. (Stewart, Tr. 2601). 

924. Dr. Frederick ignored some data because some respondents did not offer the time 

frames he was looking for. (Stewart, Tr. 2601). 
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925. Dr. Frederick’s questions provided no opportunity for respondents to qualify their 

answers. (Stewart, Tr. 2601). 

926. Ignoring some data is the same as not reporting it accurately. (Stewart, Tr. 2601). 

927. Dr. Frederick failed to analyze the data in accordance with accepted statistical 

principles. (Stewart, Tr. 2601–02). 

928. By ignoring significant portions of the data obtained in his Google Consumer 

Surveys, Dr. Frederick is misrepresenting the data. (Stewart, Tr. 2602). 

929. It is not appropriate for a researcher not to code a response because that response does 

not fit into a desirable structure. (Stewart, Tr. 2602). 

930. Dr. Frederick provided no evidence or testimony that consumer’s thought that it was 

important for a product to be labeled “biodegradable.” (Frederick, Tr. 1025–1424; 

CCX 860 (Frederick, Rep.); CCX 865 (Frederick Rebuttal Rep.)). 

931. Dr. Frederick provided no evidence or testimony that the term “biodegradable” was 

material to any consumer’s purchasing decision. (Frederick, Tr. 1025–1424; CCX 

860 (Frederick, Rep.); CCX 865 (Frederick Rebuttal Rep.)). 

932. Dr. Frederick provided no evidence or testimony that any consumer relied on any 

representation made by ECM. (Frederick, Tr. 1025–1424; CCX 860 (Frederick, 

Rep.); CCX 865 (Frederick Rebuttal Rep.)). 

933. In order to be valid, a survey must report all of the data and statistics. (Stewart, Tr. 

2602). 

934. The questions in Dr. Frederick’s Google Consumer Surveys were not clear and were 

misleading. (Stewart, Tr. 2602). 

935. For individuals who have no understanding of the general meaning of 

biodegradability, it is not clear what questions asking about biodegradability would 

mean to those individuals. (Stewart, Tr. 2602–03). 

936. Proper interview procedures as understood in generally accepted standards of survey 

research were not followed in Dr. Frederick’s Google Consumer Surveys. (Stewart, 

Tr. 2603). 

937. Dr. Frederick’s Google Consumer Surveys involved Dr. Frederick, a researcher 

knowledgeable of the desire for a particular outcome, being very active in the data 

collection and coding of the research. (Stewart, Tr. 2603). 

938. Andrew Meyer is Dr. Frederick’s graduate student. (Frederick, Tr. 1284, 1316). 

939. The process of Dr. Frederick’s Google Consumer Survey was not conducted so as to 

ensure objectivity. (Stewart, Tr. 2603). 
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940. Dr. Frederick and Mr. Meyer coded nearly all of the responses to the Google 

Consumer Survey questions. (Stewart, Tr. 2604; Frederick, Tr 1285). 

941. Dr. Frederick’s coding process was not double-blinded; the people involved in the 

actual coding were not blind. (Stewart, Tr. 2604). 

942. Dr. Frederick and Mr. Meyer were aware of the sponsor of the research, the purpose 

of the research, and understood what was sought as a result of the research. (Stewart, 

2604; Frederick, Tr. 1285) 

943. Dr. Frederick’s Google Consumer Survey is not reliable and is not valid. (Stewart, 

Tr. 2604). 

944. Dr. Frederick’s Google Consumer Survey results cannot be relied upon. (Stewart, Tr. 

2604). 

945. No conclusions can be drawn from Dr. Frederick’s Google Consumer Surveys. 

(Stewart, Tr. 2604). 

946. It is very difficult to draw any inferences about the validity of research based on an 

answer to a single question, particularly when the researcher does not know anything 

about that particular respondent. (Stewart, Tr. 2605). 

947. When there is only one question asked of a respondent, a researcher cannot know 

what the response indicates, whether it is a sincere response, whether it is a response 

that would be subject to qualification if there were a follow-up question. (Stewart, 

Tr. 2605). 

948. When there is only one question asked of a respondent, a researcher cannot know 

what that response means. (Stewart, Tr. 2605–06). 

949. A researcher cannot address the question of what a consumer’s perception of 

“biodegradable” is with a single question. (Stewart, Tr. 2606). 

950. In order to obtain nuances, dependencies, and contextual effects of a consumer’s 

belief of what “biodegradable” means, a researcher must ask follow up questions. 

(Stewart, Tr. 2606). 

951. Dr. Frederick’s used a strictly numerical approach in his Google Consumer Surveys. 

(Stewart, Tr. 2606). 

952. A strictly numerical approach is objectionable, particularly in the absence of other 

information, because it narrowly limits the ability of respondents to express their full 

opinions. (Stewart, Tr. 2606–07). 

953. By restricting responses to a particular type of response, a researcher by definition 

creates greater homogeneity than would be the case if the researcher allowed 
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respondents more latitude in terms of how they answer the question. (Stewart, Tr. 

2607). 

954. Dr. Frederick’s sampling methods were haphazard and inconsistent. (Stewart, Tr. 

2607–08; RX 856 (Stewart, Rep. at 11). 

955. As a result of Dr. Frederick’s population being poorly defined and the inability to 

know the characteristics of people who may show up at the particular website where 

Dr. Frederick’s survey questions were posted, there is no way to develop an 

assessment of whether or not the respondents to Dr. Frederick’s Google Consumer 

Survey were appropriate, interested, or even willing to give sincere responses. 

(Stewart, Tr. 2608). 

956. Many of the responses given to Dr. Frederick’s Google Consumer Survey were 

nonsensical and inappropriate to the question asked. (Stewart, Tr. 2608). 

957. The GreenBook Blog is a publication that is well-known in the practicing market 

research community and well-read researchers. (Stewart, Tr. 2611). 

958. Disinterest bias refers to the fact that if people are uninterested in a survey, if they are 

disengaged, or, even worse, if the survey serves as an interruption for an activity that 

they are more interested in than the survey, that those people will be likely to give 

insincere, random, and often nonsensical response to simply get past what is 

essentially an interruption in what they were doing before being confronted by the 

survey. (Stewart, Tr. 2609, 2612). 

959. “Editing,” in the survey research context, refers to a process whereby one or more 

neutral individuals will go through data and identify nonsensical, nonresponsive types 

and eliminate those. (Stewart, Tr. 2613). 

960. The editing process is very important and needs to be carried out by someone who is 

not knowledgeable of the purpose of the research. (Stewart, Tr. 2613). 

961. Dr. Frederick failed to appropriately use the editing process in his Google Consumer 

Surveys. (Stewart, Tr. 2616). 

962. Dr. Frederick inappropriately used the editing process to edit out responses which did 

not fit his prior notion of the structure that acceptable answers should fit. (Stewart, 

Tr. 2616). 

963. Dr. Frederick inappropriately used the editing process to push the responses in a 

direction consistent with what he was looking for as opposed to an honest reporting of 

the responses of the participants in the survey. (Stewart, Tr. 2616). 

964. The design of Dr. Frederick’s Google Consumer Surveys prevents anyone from 

making any conclusions about the source of the respondents’ false beliefs. (Stewart, 

Tr. 2616–17). 
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965. There is no evidence in or from Dr. Frederick’s Google Consumer Surveys that ECM 

caused any false belief in any respondent. (Stewart, Tr. 2617). 

966. Dr. Stewart’s survey produced very different results than Dr. Frederick’s Google 

Consumer Survey. (Stewart, Tr. 2617). 

967. Two surveys that are both flawed that produce similar results are still flawed. 

(Stewart, Tr. 2620). 

968. The fact that two flawed surveys might reflect something similar may simply reflect 

the fact that they share the same flaw. (Stewart, Tr. 2620). 

969. Regardless of how many flawed surveys produce similar results, the surveys remain 

flawed. (Stewart, Tr. 2620). 

970. When numerous flawed surveys produce similar outcomes, the similarity of outcomes 

may simply be a reflection of the fact that the flawed surveys share the same flaw. 

(Stewart, Tr. 2620). 

971. Dr. Frederick adopted a rule in coding his responses that held that any response with a 

number and a unit was counted, whether valid or not. (Stewart, Tr. 2613). 

972. Dr. Frederick did not code response to his Google Consumer Survey questions that 

suggest that the respondent did not know the answer. (Stewart, Tr. 2613; RX 856 

(Stewart, Rep. at 12)). 

973. The implications of Dr. Fredrick failing to code response wherein respondents are 

suggesting that they do not know the answer are 1) that no one can know how many 

people who gave a response that Dr. Frederick coded might have actually not known 

an answer, but gave a response he or she thought valid to get through the survey wall; 

and 2) that to the extent that “don’t know” is a perfectly reasonable response, the 

researcher needs to include those individuals who do not know into the total 

sample—the “don’t know” responses cannot be ignored simply because they did not 

give the type of answer the researcher wanted. (Stewart, Tr. 2614). 

974. The coding in Dr. Frederick’s Google Consumer Surveys was not double blind. 

(Stewart, Tr. 2615). 

975. In Dr. Frederick’s Google Consumer Surveys, the people doing the vast majority of 

the coding were fully aware of what was being sought from the survey. (Stewart, Tr. 

2615; Frederick, Tr. 1285). 

976. Dr. Frederick’s coding of his Google Consumer Surveys lacked objectivity because 

the coding ignored certain responses that did not fit into the form of answer that Dr. 

Frederick desired. (Stewart, Tr. 2615; Frederick, Tr. 1128). 

977. The results of Dr. Frederick’s coding demonstrate that there was a clear desire to push 

the responses in a particular direction. (Stewart, Tr. 2615). 
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978. The coding in Dr. Frederick’s Google Consumer Surveys lacked objectivity. 

(Stewart, Tr. 2615). 

979. Using Google Consumer Surveys, Dr. Frederick asked a single question to nearly 

29,000 individual respondents. (Frederick, Tr. 1060, 1207, 1223). 

980. When Judge Chappell asked Dr. Frederick “did I understand you to say that anyone 

who responds to the Google survey, each person only gets one question?” Dr. 

Frederick replied “in my survey, any single respondent only received one question.” 

(Frederick, Tr. 1217) 

981. When Judge Chappell then clarified, “so one person may say how long does it take 

for a product to biodegrade, and that same person is not asked how long does it take 

for a product to biodegrade.” Dr. Frederick answered “that’s absolutely correct.” 

(Frederick, Tr. 1217). 

982. Dr. Frederick is not familiar with anonymous browsing features. (Frederick, Tr. 

1088). 

983. Dr. Frederick does not know what Google does with a respondent to a Google 

Consumer Survey question that, for example, goes to a proxy server or uses any of 

the new anonymous surfing features on most late editions of web browsers. 

(Frederick, Tr. 1088–89). 

984. Dr. Frederick does not know what Google does if a respondent uses some type of 

cloaking or anonymous technology before responding to a Google Consumer Survey 

question. (Frederick, Tr. 1088). 

985. Dr. Frederick does not know what proxy servers are. (Frederick, Tr. 1088). 

986. Google, and not Dr. Frederick, chooses the websites on which to present the surveys. 

987. The Federal Trade Commission has never relied upon a Google Consumer Survey as 

the basis for its decision in administrative case. (Frederick, Tr. 1191). 

988. A person engaged in an online search for specific content can suddenly be presented 

with an unanticipated popup or a survey wall that contains a single survey question, 

or multiple survey questions from Google Consumer Surveys. (Frederick, Tr. 1207). 

989. Dr. Frederick does not know which websites featured his survey questions. 

(Frederick, Tr. 1208). 

990. Dr. Frederick does not know the specific sites on which any particular respondent 

encountered his Google Consumer Survey questions. (Frederick, Tr. 1209). 

991. When a person using the internet encounters a Google Consumer Survey question 

after clicking a link, that person gets some of the content from that link, but the rest of 
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the content is redacted unless and until that person either completes the Google 

Consumer Survey question or pays money for the content. (Frederick, Tr. 1212). 

992. Dr. Frederick did not choose the number of websites on which his questions were 

posted. (Frederick, Tr. 1213). 

993. Google limits the number of characters in a survey question to a set figure. 

(Frederick, Tr. 1214–15). 

994. In three separate instances Dr. Frederick had to revise questions he wanted to ask 

survey respondents because his proposed questions contained too many characters 

according to Google. (Frederick, Tr. 1215). 

995. Dr. Frederick used four types of questions in his surveys: open-ended questions, 

binary questions, multichotomous questions, and hybrid questions. (Frederick, Tr. 

1215–16). 

996. In an open-ended question a respondent can type in whatever he or she wants. 

(Frederick, Tr. 1215–16). 

997. In a binary question, the respondent can click either the button yes or the button no. 

(Frederick, Tr. 1516). 

998. In a multichotomous question, the respondent can choose one of five answers. 

999. In a hybrid question, respondents were restricted to providing a numeric answer. 

(Frederick, Tr. 1216). 

1000. For the binary and multichotomous questions, Dr. Frederick does not know whether 

any answers given by respondents were valid. (Frederick, Tr. 1220). 

1001. In the binary and multichotomous questions, Dr. Frederick believes that some 

respondents were actually just clicking buttons at random in order to get through the 

survey. (Frederick, Tr. 1220). 

1002. Dr. Frederick did not ask any questions of respondents in his Google Consumer 

Surveys to determine if the respondents understood the meaning of any of the terms 

in the questions. (Frederick, Tr. 1228). 

1003. Dr. Frederick did not ask any questions in his Google Consumer Surveys to prevent 

those who lack knowledge of, or an interest in, the subject matter of plastic 

biodegradation from participating in his surveys. (Frederick, Tr. 1228). 

1004. Google provides only indirect circumstantial evidence or information on Google 

Consumer Survey’s respondents’ demographics. (Frederick, Tr. 1229). 
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1005. Google uses a respondent’s cookies or web site visitation information to infer a 

respondent’s gender and age, and these inferences can be wrong. (Frederick, Tr. 

1229). 

1006. According to Dr. Frederick, “there are several reasons why it would be difficult for 

Google to make, you know, a really accurate imputation of various demographic 

characteristics. (Frederick, Tr. 1230). 

1007. Dr. Frederick, could have, but chose not to, ask any two part questions in his surveys 

where the first question obtains direct information on the respondent’s demographics. 

(Frederick, Tr. 1231). 

1008. Dr. Frederick is confused as to who the relevant population was for his survey, 

whether it is “any adult that would buy a plastic product” or “any person who would 

buy a plastic product.” (Frederick, Tr. 1232). 

1009. Dr. Frederick has no way of knowing whether someone who would not buy a plastic 

product participated in his Google Consumer Surveys. (Frederick, Tr. 1235–36). 

1010. Regardless of how Dr. Frederick wanted to define his survey population, Google 

defined it for him as the “general population in the United States on Google 

Consumer Surveys Publisher Network.” (Frederick, Tr. 1238–39). 

1011. People who are not adults may have responded to Dr. Frederick’s survey. (Frederick, 

Tr. 1239). 

1012. An IP address of a survey respondent can only tell Google the location, but not the 

age, nationality, or gender of the person who is actually answered the survey 

question. (Frederick, Tr. 1239). 

1013. Google, and by extension Dr. Frederick, cannot know who is answering any given 

Google Consumer Survey question. (Frederick, Tr. 1239). 

1014. Google Consumer Surveys provides no means for the surveyor to follow up with a 

respondent in order to gain a better understanding of what the respondent intended to 

convey in his or her response to an open-ended question. (Frederick, Tr. 1247–48). 

1015. Dr. Frederick does not contend that all responses to his Google Consumer Surveys 

were given sincerely. (Frederick, Tr. 1248–49). 

1016. Dr. Frederick does not contend that all respondents who answered his Google 

Consumer Survey questions actually read the questions. (Frederick, Tr. 1253). 

1017. Dr. Frederick’s only basis for determining whether any given response to any 

question in his Google Consumer Surveys is sincere is “entirely inferential.” 

(Frederick, Tr. 1254). 
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1018. Dr. Frederick does not contend that all respondents to his Google Consumer Surveys 

comprehended every term in his questions. (Frederick, Tr. 1254). 

1019. Seventy-five percent of potential respondents who saw Dr. Frederick’s Google 

Consumer Survey questions opted not to answer the question. (Frederick, Tr. 1254-

55). 

1020. Dr. Frederick is one of the authors of an article entitled “The Limits of Attraction.” 

(CCX 977). 

1021. This article notes that some respondents who answer questions from Google 

Consumer Surveys “answer randomly to regain access to the web page as quickly as 

possible[.]” (CCX 977 at P. 5 n. 5). 

1022. Dr. Frederick thinks “it’s a certainty” that some respondents to Google Consumer 

Survey questions will answer questions randomly. (Frederick, Tr. 1257). 

1023. The images Dr. Frederick used in his Google Consumer Survey questions are not 

actual images of products in the marketplace. (Frederick, Tr. 1265). 

1024. The images Dr. Frederick used in his Google Consumer Survey questions are 

invented photo-shopped images created electronically by Andrew Meyer’s wife, who 

superimposed the ECM logo onto certain electronic images. (Frederick, Tr. 1265, 

1316). 

1025. Dr. Frederick has never seen any actual product containing an ECM logo or the words 

“biodegradable from ECM.” (Frederick, Tr. 1266). 

1026. Dr. Frederick did not specify in his Google Consumer Survey questions the type of 

plastic to which he was referring to in any given question. (Frederick, Tr. 1266). 

1027. One such image created by Dr. Frederick and his employees was what appeared to be 

a Tupperware container with the ECM logo; this Tupperware container appears to be 

thicker than other plastic images Dr. Frederick used in his Google Consumer Surveys. 

(Frederick, Tr. 1266–67; CCX 860 (Frederick, Rep. at 31–32)). 

1028. None of the questions in Dr. Frederick’s Google Consumer Surveys were identical to 

any of the questions in the APCO or Synovate surveys. (Frederick, Tr. 1277–78). 

1029. Dr. Frederick’s Google Consumer Survey did not use the same survey method as 

either the APCO or Synovate surveys. (Frederick, Tr. 1278). 

1030. Dr. Frederick defines coding as extracting from a raw response to a survey question 

an amount of time. (Frederick, Tr. 1282). 

1031. Dr. Frederick, Andrew Meyer, Mohammad Saeed, Lacie D’Amato, and Jane Coates 

were the coders for Dr. Frederick’s Google Consumer Surveys. (Frederick, Tr. 

1282). 
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1032. Andrew Meyer is Dr. Frederick’s graduate student. (Frederick, Tr. 1284). 

1033. Mohammad Saeed is an undergraduate student. (Frederick, Tr. 1285). 

1034. According to Dr. Frederick, some degree of judgment is required in order to code 

response. (Frederick, Tr. 1283). 

1035. Mr. Meyer was aware that FTC was the sponsor of the Google Consumer Surveys. 

(Frederick, Tr. 1285). 

1036. Dr. Frederick was the primary coder of the Google Consumer Surveys. (Frederick, 

Tr. 1285). 

1037. Collectively, Dr. Frederick and Mr. Meyer coded almost all of the responses to Dr. 

Frederick’s Google Consumer Surveys. (Frederick, Tr. 1285). 

1038. Both Dr. Frederick and Mr. Meyer knew that ECM is the respondent in this case. 

(Frederick, Tr. 1286). 

1039. The first e-mail Dr. Frederick received regarding this proceeding was from Bob 

Klein, president of Applied Marketing Sciences, Inc., on February 3, 2014. 

(Frederick, Tr. 1287–88; RX 814). 

1040. The first e-mail Dr. Frederick received regarding this proceeding stated in its entirety: 

Hi Shane – 

An interesting opportunity has come up that you may be interested 

in. The FTC is going after a maker of an additive to plastic that 

claims to make the resulting film “biodegradable.” Science says it 

doesn’t work. One of their advertising claims is “biodegrades in 

some period greater than one year” (which is ridiculous when you 

think it because everything will biodegrade eventually.) But the 

issue is anchoring which is why I am calling you. Will this claim 

result in consumers thinking that it is closer to a year than 100 

years? Is it okay for me to pass your name along to the FTC 

attorney who can explain more about what he wants. My sense is 

that it will be a short report that spells out your credentials and 

states your opinion. There will be a trial in June. He would like to 

speak with you this week if you are interested. Let me know if is 

okay to pass your name along to him. 

(RX 814). 

1041. As a coder and as the principal investigator, Dr. Frederick purportedly exercised his 

judgment to set a bright-line rule no non-numerical response of time periods to his 

Google Consumer Survey question would be coded. (Frederick, Tr. 1306). 
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1042. When coding responses to his Google Consumer Survey questions, Dr. Frederick 

chose to exclude from his data answers like “I don’t know,” “it varies,” and “it 

depends,” “depends on what it is made of,” “depends on what it is made of, who 

knows,” who knows,” “unknown,” “depends on what it is,” “not sure,” varies,” “I 

think it varies,” “it depends on what type of material,” “no idea,” “I have no clue,” 

“depends on the type of material,” “depends on environment,” “depends on product,” 

“not enough information,” “it varies based on many different conditions,” “depends 

on the material,” “ambiguous,” “it would be ambig,” and “ambig.” (Frederick, Tr. 

1299; 1306–09). 

1043. Dr. Frederick chose to code the raw responses of “one nanosecond,” “forever,” “24 

hours,” “immediately,” “17 days,” “one hour,” “one second,” “a human lifetime,” 

“10,100 years,” “ten minutes,” “122 minutes,” “one minute,” “one hour,” “ten 

seconds,” “276.5 days,” one second,” “ten minutes,” “minutes,” “22 days,” “72 

hours,” “30 minutes,” “45 seconds,” a week,” “90 minutes,” 60 seconds,” “a few 

days,” and “one hour.” (Frederick, Tr. 1302–05; RX 951). 

1044. Dr. Frederick chose to code the raw response “never.” (Frederick, Tr. 1302; RX 951). 

1045. According to Dr. Frederick, a respondent who is otherwise predisposed to take a 

survey question seriously might think that a question about how much time a plastic 

takes to biodegrade is ridiculous because it lacks essential facts. (Frederick, Tr. 

1313). 

1046. According to Dr. Frederick, a person who does not take a survey question seriously is 

more likely to answer that question insincerely, whimsically, or with just a guess. 

(Frederick, Tr. 1313–14). 

1047. According to Dr. Frederick, most people do not have the experience of watching a 

plastic biodegrade. (Frederick, Tr. 1315). 

1048. Not a single one of the images Dr. Frederick used in his Google Consumer Surveys 

was an actual plastic product in the market with an ECM logo or with a biodegradable 

claim upon it. (Frederick, Tr. 1317). 

1049. Andrew Meyer’s wife, who photo-shopped the images used in Dr. Frederick’s survey, 

was probably aware that ECM was the respondent in this case and that this was being 

brought by the FTC against ECM. (Frederick, Tr. 1317–18). 

1050. Dr. Frederick has never seen any product that contained both the ECM logo and term 

“biodegradable” on it. (Frederick, Tr. 1318). 

1051. Dr. Frederick had no formatting discretion when presenting images in his Google 

survey because Google provides only fifteen image formats from which to choose. 

(Frederick, Tr. 1319). 

1052. Dr. Frederick had no ability to control how much contrast Google used when 

presenting the images in his Google Consumer Surveys. (Frederick, Tr. 1319). 
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1053. Dr. Frederick had no ability to control the actual screen size that is presented to a 

respondent answering his Google Consumer Surveys. (Frederick, Tr. 1319). 

1054. Dr. Frederick had no ability to control the number of pixels associated with the 

images he used in his Google Consumer Surveys. (Frederick, Tr. 1319). 

1055. At the time Dr. Frederick conducted his Google Consumer Surveys, he had never 

actually seen a Google Consumer Survey question live on a website. (Frederick, Tr. 

1320). 

1056. According to Dr. Frederick, Google Consumer Survey respondents sometimes give 

random answers to questions. (Frederick, Tr. 1320). 

1057. According to Dr. Frederick, a stratified sample is when you try to have a full range of 

demographic characteristics in a study. (Frederick, Tr. 1322). 

1058. According to Dr. Frederick, Google Consumer Survey attempts to have a stratified 

sample by merely inferring demographic characteristics. (Frederick, Tr. 1322). 

1059. Dr. Frederick does not know how many people with cell phones live in households 

with landlines. (Frederick, Tr. 1324). 

1060. Dr. Frederick does not know how many adult children live with their parents or 

grandparents in the United States. (Frederick, Tr. 1325). 

1061. Complaint Counsel provided Dr. Frederick with CCX 862, which is information on 

the demographics of the United States’ population from the Census Bureau. 

(Frederick, Tr. 1327; CCX 862). 

1062. According to Dr. Frederick, about 40% of Americans over age 14 are also over age 

50. (Frederick, Tr. 1327; CCX 862). 

1063. According to Dr. Frederick about half of Americans over age 19 are also over age 50. 

(Frederick, Tr. 1327; CCX 862). 

1064. Dr. Frederick does not know what percentage of people in the United States under 

age 50 access the internet exclusively through mobile devices. 

1065. Dr. Frederick does not know whether people can access a Google Consumer Survey 

on a mobile device. (Frederick, Tr. 1329). 

1066. Dr. Frederick does not know what percentage of global mobile internet users use a 

mobile device as their primary or exclusive means of using the internet. (Frederick, 

Tr. 1331). 

1067. Dr. Frederick believes that younger people use more mobile devices and that older 

people tend to you fixed PC to access the internet. (Frederick, Tr. 1332). 
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1068. Dr. Frederick does not know the difference between a static IP address and a dynamic 

IP address. (Frederick, Tr. 1332). 

1069. Dr. Frederick is not familiar with dynamic host configuration protocol. (Frederick, 

Tr. 1333). 

1070. Dr. Frederick does not know how dynamic host configuration protocol assigns IP 

addresses. (Frederick, Tr. 1333). 

1071. Dr. Frederick does not know what percentage of internet users block cookies. 

(Frederick, Tr. 1335). 

1072. Dr. Frederick does not know what percentage of internet users mask their identities 

online. (Frederick, Tr. 1335) 

1073. Dr. Frederick does not know what percentage of internet users rely on Google 

Chrome’s feature that allows you to browse privately. (Frederick, Tr. 1334–35). 

1074. Dr. Frederick does not know whether Google accepts a response from a user 

browsing anonymously. (Frederick, Tr. 1337). 

1075. If a family of four shares one computer, and one of those users answers a Google 

Consumer Survey question, neither Google nor the surveyor can know which of those 

four users answered the survey question. (Frederick, Tr. 1337-38). 

1076. Dr. Frederick cannot know what caused his survey respondents to wait 20 seconds 

before keying in a response to his survey questions. (Frederick, Tr. 1342). 

1077. Survey respondents were able to read part of the article before deciding whether to 

answer the Google Consumer Survey question in Dr. Frederick’s surveys. (Frederick, 

Tr. 1343). 

1078. Dr. Frederick cannot account for the exact reason why any particular person took 22 

seconds to respond to his survey questions. (Frederick, Tr. 1344). 

1079. The only qualified claims Dr. Frederick tested in his Google Consumer surveys were 

ECM’s former nine month to five year qualification and ECM’s some period greater 

than a year claims. (Frederick, Tr. 1345–46). 

1080. Before writing his expert report, Dr. Frederick had never read the FTC’s Green 

Guides. (Frederick, Tr. 1346). 

1081. In support of the One Year Rule, FTC relies on a survey conducted by APCO Insight, 

and dismisses a survey conducted by Synovate. (RX 347, at § IV(E)(4)(A)). 

1082. According to FTC, the APCO survey concluded that 60% of respondents expect that 

an item marketed as degradable will fully decompose in one year or less. (RX 347, at 

§ IV(E)(4)(A)). 
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1083. However, four of the six potential answer choices fell within the range of “one year or 

less.” (RX 856 (Stewart Rep. at 7)). 

1084. A random selection of these potential answer choices would yield 66% falling within 

the range of “one year or less,” and when people are asked questions about that which 

they know little, a near perfect distribution of answer choices should be expected. 

(RX 856 (Stewart Rep. at 8)). 

1085. Dr. Frederick is unfamiliar with the Reference Manual on Scientific Evidence, and 

has no “specific criterion in mind” as to what makes a survey valid. (Frederick, Tr. 

1185–1191; RX 858 (Frederick, Dep. at 186)). 

1086. Dr. Frederick does not “know what other people have written” regarding what 

constitutes acceptable survey principles that define a valid survey. (RX 858 

(Frederick, Dep. at 186–187)). 

1087. Dr. Frederick chose the Google Survey interface despite the fact that no Google 

Consumer Survey has ever been relied upon as evidence in an FTC proceeding, and 

that its use has never been approved of or validated in any peer reviewed literature. 

(Frederick, Tr. 1191; RX 858 (Frederick, Dep. at 189)). 

1088. Dr. Frederick also chose to use a Google Consumer Survey to save money. 

(Frederick, Tr. 1206; RX 858 (Frederick, Dep. at 123)). 

1089. Dr. Frederick was paid a flat fee of $40,000 by the FTC, of which Dr. Frederick was 

entitled to keep whatever amount he did not spend. (Frederick, Tr. 1201; RX 858 

(Frederick, Dep. at 8)). 

1090. There is no way to ascertain the degree to which the sample of respondents used in 

Google Consumer Surveys is representative of any identifiable population; the sample 

itself is unknown and unknowable, because there is no verification of respondents 

with Google Survey; rather, information on respondents is merely inferred by Google 

from information associated with or that resides on a computer. (Frederick, Tr. 1228; 

RX 856 (Stewart, Rep. at 10–11)). 

1091. Dr. Frederick declined to pay the additional fee to include two-part questions that 

would have provided direct information about the respondent population. (Frederick, 

Tr. 1230–1231). 

1092. Dr. Frederick rejected the option of including screener questions in his Google 

surveys. (Frederick, Tr. 1224). 

1093. Google survey uses no screener questions to assure that the respondent is of relevant 

age or even understands the English language. (RX 856 (Stewart, Rep. at 11)). 

1094. Dr. Frederick admits that his Google survey population is not representative of the 

target population; stating that there are “two populations here...the population about 
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which we’re trying to draw inferences... [and] the people who answered the surveys 

that I posted on Google Consumer Surveys.” (Frederick, Tr. 1234). 

1095. Google survey generally works by giving internet users access to “premium content” 

in exchange for answering a question, as opposed to paying for a subscription; 

therefore, the questions are at best a distraction and barrier to respondents whose 

objective is to access information, not complete a survey. (Frederick, Tr. 1206–1207; 

RX 856 (Stewart, Rep. at 11)). 

1096. The disinterest bias explains why so many respondents answered Dr. Frederick’s 

survey with nonsensical answers. (RX 856 (Stewart, Rep. at 11)). 

1097. While Dr. Stewart’s survey utilized well-trained and blind coders, Dr. Frederick 

merely vetted coders for the ability to read and follow directions and did not ensure 

blinding. (RX 856 (Stewart, Rep. at 26); RX 858 (Frederick, Dep. at 168–169)). 

1098. Dr. Frederick’s coders did not consistently apply the coding rules. (RX 856 (Stewart, 

Rep. at 13)). 

1099. Dr. Frederick’s survey failed to code accurate and relevant responses such as “don’t 

know.” (Frederick, Tr. 1306–1308; RX 856 (Stewart, Rep. at 12)). 

1100. Dr. Frederick’s survey did not code answers indicating critical thought by the 

respondent, such as, “it depends on where it ends up” or “it depends on what it is.” 

(Frederick, Tr. 1306–1308). 

1101. Dr. Frederick’s supervising coder, Andrew Meyer, was aware that Dr. Frederick’s 

research was going to be used by Complaint Counsel against ECM. (Frederick, Tr. 

1285–1287; RX 858 (Frederick, Dep. at 176)). 

1102. This failure to use “blind coders” deviates from customary practice and may infect 

the survey with coder bias. (RX 856 (Stewart Rep. at 13)). 

1103. Unlike in Dr. Stewart’s survey, there is no evidence that Dr. Frederick used multiple 

coders in the coding process to implement a reliability check. (RX 856 (Stewart, Rep. 

at 13)). 

1104. Significant flaws aside, Dr. Frederick’s survey indicates considerable diversity among 

respondents in terms of their claimed knowledge about biodegradable products and 

their views about the time it takes various materials to biodegrade. (RX 856 (Stewart 

Rep. at 13-14)). 

VIII. COMPLAINT COUNSEL HAS NOT DEMONSTRATED THAT THE RATE OF 

BIODEGRADATION IN LANDFILLS IS MATERIAL TO CONSUMER 

PURCHASING DECISIONS 
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1105. In support of his expert opinion in this case, Dr. Stewart performed a survey in the 

spring of 2014. (Stewart, Tr. 2494). 

1106. When exploring a new field of consumer survey research that has not previously been 

researched extensively it is best to conduct open-ended survey research with a 

personal interviewer, either face to face or by telephone. (Stewart, Tr. 2510). 

1107. Using a personal interviewer in a survey affords the surveyor to explore in depth what 

people’s perceptions are. (Stewart, Tr. 2510). 

1108. The subject of public perception of biodegradation and biodegradation of plastics as a 

field of consumer survey research has not been researched extensively. (Stewart, Tr. 

2510–11). 

1109. Outside of the surveys conducted for the present litigation, only two surveys exist that 

explore the issue of public perception of biodegradation and biodegradation of 

plastics. (Stewart, Tr. 2511). 

1110. Given the limited amount of research work done in the field of public perception of 

biodegradation and biodegradation of plastics, the survey methodologies that should 

be used to explore that field can only be done with a personal interview and the use of 

open-ended questions. (Stewart, Tr. 2511). 

1111. Dr. Stewart reviewed the APCO study and the Synovate study. (Stewart, Tr. 2512). 

1112. One purported purpose of the APCO survey was to discern public perception of the 

rate of biodegradation. (Stewart, Tr. 2514). 

1113. The APCO study used mostly closed-ended questions. (Stewart, Tr. 2513). 

1114. The Synovate survey included questions relative to the rate of biodegradation. 

(Stewart, Tr. 2515). 

1115. Closed-ended questions are questions where a list of possible responses to a question 

are provided to the respondent, and where the respondent must choose from one of 

the responses that were provided in order to give an answer to the question. (Stewart, 

Tr. 2513). 

1116. The form of the questions used in the APCO survey was premature given the state of 

knowledge of the topics covered by the APCO survey. (Stewart, Tr. 2513). 

1117. Closed-ended questions are appropriate only where the surveyor already has a deep 

understanding of all potential responses that an individual might give to a question. 

(Stewart, Tr. 2513). 

1118. The response options given in the APCO survey were incomplete. (Stewart, Tr. 

2513). 
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1119. The response options in the APCO survey to questions about how long it should take 

for something to biodegrade were not balanced. (Stewart, Tr. 2514). 

1120. Two-thirds of the response options in the APCO survey to the question of how long it 

should take for something to biodegrade were one year or less, which predisposes 

people to select a short time frame than a longer time frame. (Stewart, Tr. 2514). 

1121. With respect to the question of how long it would take something to biodegrade, the 

APCO survey is invalid. (Stewart, Tr. 2514). 

1122. The APCO survey is invalid because it does not provide adequate opportunity for 

respondents to offer their perceptions. (Stewart, Tr. 2514). 

1123. The APCO survey’s question of how long it would take something to biodegrade is 

biased because it offers many more opportunities to select an answer that reflects one 

year or less than a longer time period. (Stewart, Tr. 2514–15). 

1124. The Synovate survey inappropriately uses closed-ended questions when asking about 

the length of time that biodegradation should occur. (Stewart, Tr. 2515). 

1125. The response options in the Synovate survey for the question of how long should 

something take to biodegrade are biased. (Stewart, Tr. 2515). 

1126. Given the current understanding and state of knowledge with respect to consumer 

perception of biodegradation, open-ended questions are much more suitable, 

appropriate, and informative than closed-ended questions. (Stewart, Tr. 2516). 

1127. One problem with closed-ended questions is that the limited response options may 

preclude respondents from giving an accurate answer that reflects their real 

perceptions by forcing the respondent to choose a response that may most closely 

reflect his or her view but may not be close at all. (Stewart, Tr. 2517). 

1128. On reason why surveyors need more work involving open-ended questions and 

interviews early in the exploration of a topic like biodegradation is so that surveyors 

can be sure that when they do finally design closed-ended questions, that they give 

people the full array of response options. (Stewart, Tr. 2517). 

1129. “Misleading homogeneity” is a situation in which one characterizes a sample or a 

population as being more alike, more similar, or more homogeneous than is actually 

the case. (Stewart, Tr. 2518). 

1130. Misleading homogeneity in a survey occurs when respondents have a limited number 

of potential responses they can offer. (Stewart, Tr. 2518). 

1131. The APCO survey afforded respondents no opportunity for any dependencies or 

contexts. (Stewart, Tr. 2519). 
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1132. The Synovate survey results in misleading homogeneity because of the relatively 

small number of time frames in the response options. (Stewart, Tr. 2520). 

1133. Consumers have nuanced perceptions of biodegradability. (Stewart, Tr. 2630). 

1134. There is evidence that consumers who purchase biodegradable products seek out and 

obtain truthful scientific information about what “biodegradable” means. (Stewart, 

Tr. 2658–59). 

1135. If there are no shared beliefs among consumers, there is no evidence that deception 

occurred. (Stewart, Tr. 2660). 

1136. According to Dr. Frederick, a protest or bypass response is a response given by a 

respondent for the sole purpose of getting past a survey wall. (Frederick, Tr. 1123). 

1137. In a telephone survey, a protest response is in the form of the respondent hanging up 

the telephone. (Stewart, Tr. 2665), 

1138. In an internet survey, where the respondent must enter some information in order to 

obtain desired content, a protest response can take any number of forms, including 

what could be interpreted answers. (Stewart, Tr. 2666; Frederick, Tr. 1123). 

1139. In terms of the validity of a survey, it is far better for a protest response to be a hang 

up of the telephone—thus providing the researcher absolutely no data—than entering 

a protest response into a survey which actually becomes incorporated into the larger 

data set and is ultimately used in an analysis. (Stewart, Tr. 2666). 

1140. The composition of Dr. Frederick’s Google Consumer Survey sample cannot be 

known. (Stewart, Tr. 2672–73). 

1141. Dr. Stewart obtained demographic information from his respondents directly. 

(Stewart, Tr. 2672–75). 

1142. Dr. Frederick received demographic information from Google that Google merely 

inferred. (Stewart, Tr. 2674–75, 2743). 

1143. Google Consumer Surveys is an untested product. (Stewart, Tr. 2683). 

1144. Google Consumer Surveys is not a transparent product. (Stewart, Tr. 2683). 

1145. Google Consumer Surveys will not provide market researchers sufficient information 

to adequately evaluate the product. (Stewart, Tr. 2683). 

1146. Many professional marketing associations require transparency when evaluating 

whether a survey product is legitimate. (Stewart, Tr. 2683). 

1147. Most marketing research professionals agree that Google Consumer Surveys is not in 

the legitimate market research business. (Stewart, Tr. 2683). 
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1148. There is no such thing as misleading heterogeneity. (Stewart, Tr. 2770). 

1149. To the extent that misleading heterogeneity exists, it is not analogous to misleading 

homogeneity. (Stewart, Tr. 2770). 

1150. Scholars have written two responses criticizing Dr. Frederick’s article entitled “The 

Limits of Attraction.” (Stewart, Tr. 2807). 

1151. The article entitled “The Limits of Attraction” does not rely on Google Consumer 

Surveys at all. (Stewart, Tr. 2808). 

1152. The only reference to Google Consumer Surveys in the article entitled “The Limits of 

Attraction” was in a footnote. (Stewart, Tr. 2808; CCX 977). 

1153. The footnote in the article entitled “The Limits of Attraction” referring to Google 

Consumer Surveys was neither supportive nor non-supportive of what was actually 

contained in “The Limits of Attraction” article. (Stewart, Tr. 2808). 

1154. Dr. Stewart coded every response to his survey. (Stewart, Tr. 2810). 

1155. Dr. Frederick coded only those responses which happened to give a numerical score a 

time interval. (Stewart, Tr. 2810). 

1156. Dr. Stewart’s codes classified the actual responses of the survey participants. 

(Stewart, Tr. 2811). 

1157. The totality of the questions asked in Dr. Stewart’s survey provided a much brighter 

and richer picture of people’s perceptions of biodegradability than if Dr. Stewart 

asked only one question of each respondent. (Stewart, Tr. 2812). 

1158. In interpreting the meaning of any specific time offered by a survey respondent, it is 

important to know how they responded to other questions in the survey. (Stewart, Tr. 

2813). 

1159. Virtually everyone understands that the time a product takes to biodegrade is 

dependent upon a variety of factors. (Stewart, Tr. 2813). 

1160. The totality of the evidence obtained from Dr. Stewart’s survey indicates that 

consumers have a very rich and nuanced understanding of biodegradability. (Stewart, 

Tr. 2814). 

1161. Consumers understand that the process of biodegradation is highly dependent upon 

the type of material, the environment, the size of material, and the biodegrading 

context. (Stewart, Tr. 2814). 

1162. There is a huge variety of opinions among consumers about how long biodegradation 

actually takes and what the process actually entails. (Stewart, Tr. 2814). 
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1163. There is an empirical basis for concluding that the ages of the respondents in Dr. 

Stewart’s survey were representative of the relevant population. (Stewart, Tr. 2808). 

1164. Dr. Stewart’s survey was designed and conducted under a variety of general 

principles of survey research that are reflected in various textbooks and in other 

treatments of survey research. (Stewart, Tr. 2521). 

1165. The Manual for Complex Litigation lists specific characteristics that a reliable and 

valid survey should possess, and those principles reflect the general understanding in 

the professional literature. (Stewart, Tr. 2521). 

1166. In designing and implementing his survey, Dr. Stewart relied upon the principle that 

the relevant population should be clearly identified. (Stewart, Tr. 2522–23). 

1167. When designing a survey, the individuals or other entities to which one wants to 

extrapolate the results of a survey need to be very clearly identified, appropriate, and 

relevant to whatever the issue may be. (Stewart, Tr. 2523). 

1168. In designing and implementing his survey, Dr. Stewart relied upon the principle that 

there needs to be a well-articulated sampling plan that results in sample from the 

population—a smaller subset of individuals from the relevant population so that the 

results of the survey can be extrapolated to the relevant population. (Stewart, Tr. 

2523). 

1169. In designing and implementing his survey, Dr. Stewart relied upon the principle that 

the questions asked must be clear and not misleading (Stewart, Tr. 2523). 

1170. In designing and implementing his survey, Dr. Stewart relied upon the principle that 

the survey needs to be designed and implemented by people who are well-qualified 

and who follow well-accepted procedures. (Stewart, Tr. 2523). 

1171. In designing and implementing his survey, Dr. Stewart relied upon the principle that 

the data analysis needs to follow well-accepted standards of data analysis. (Stewart, 

Tr. 2523). 

1172. All four of the general standards Dr. Stewart relied upon when implementing and 

designing his survey in this case, “really need[] to be used as the metric against which 

one evaluates the reliability and validity of a survey.” (Stewart, Tr. 2524). 

1173. The Federal Trade Commission accepts and applies the standards that are articulated 

in most professional organizations as well as in the Manual for Complex Litigation. 

(Stewart, Tr. 2525). 

1174. Dr. Stewart’s survey used interviewers who could ask follow-up questions and use 

probes to obtain more complete answers from respondents. (Stewart, Tr. 2526). 
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1175. Dr. Stewart’s survey also utilized some open-ended questions in order to fully explore 

people’s complete perceptions rather than simply asking people to select from a set of 

predetermined alternatives. (Stewart, Tr. 2526). 

1176. Dr. Stewart ultimately decided to conduct a telephone survey because it is more 

efficient than a mall intercept or a central location study while maintaining the benefit 

of an interviewer and open-ended questions. (Stewart, Tr. 2526–27). 

1177. By using a telephone survey, Dr. Stewart was able to obtain a more representative 

sample than using a mall intercept survey. (Stewart, Tr. 2527). 

1178. The interviewers in Dr. Stewart’s survey were live callers who were well –trained 

professional interviewers who were assisted in their work by computer-assisted 

telephone interviewing technology which provides a means by which their work 

could be monitored and a means for capturing responses of the survey respondents. 

(Stewart, Tr. 2527). 

1179. Dr. Stewart authored the questions used in his survey. (Stewart, Tr. 2527). 

1180. Dr. Stewart identified the universe studied in his survey. (Stewart, Tr. 2527). 

1181. Dr. Stewart identified the sampling source used for making phone calls in his survey. 

(Stewart, Tr. 2527–28). 

1182. California Survey Research Services programmed Dr. Stewart’s questionnaire into 

the computer-assisted telephone interviewing under Dr. Stewart’s direction. (Stewart, 

Tr. 2528). 

1183. Dr. Stewart has relied upon California Survey Research Services in a variety of 

contexts for more than twenty years. (Stewart, Tr. 2528). 

1184. Other than ECM’s attorneys providing Dr. Stewart with the initial issue, “what does 

‘biodegradable’ mean to consumers,” it was entirely Dr. Stewart’s responsibility to 

design, implement, and interpret the survey. (Stewart, Tr. 2529). 

1185. Dr. Stewart was wholly responsible for writing the questions asked in his survey. 

(Stewart, Tr. 2529). 

1186. Dr. Stewart’s survey was a telephone interview assisted by a technology known as 

computer-assisted telephone interviewing. (Stewart, Tr. 2529). 

1187. Dr. Stewart’s survey intended to use a large majority of open ended questions. 

(Stewart, Tr. 2529-30). 

1188. Dr. Stewart’s survey was intended to obtain a random sample of households with 

landlines. (Stewart, Tr. 2529–30). 
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1189. The acronym for computer-assisted telephone interviewing is “CATI.” (Stewart, Tr. 

2530). 

1190. CATI is essentially hardware and software that is designed to create a structure to 

assist interviewers in the design and implementation of a telephone survey. (Stewart, 

Tr. 2530). 

1191. CATI essentially automates the dialing of telephone numbers so that it takes the 

control of what number is dialed away from the interviewer. (Stewart, Tr. 2530). 

1192. Once CATI reaches a connection with a potential respondent, CATI causes the 

interviewer’s monitor to bring up one question at a time so that there is no 

opportunity for the interviewer to deviate from the order of questions. (Stewart, Tr. 

2530–31). 

1193. After recording a response from a respondent, the interviewer clicks a “continue” 

button that brings up the next question in the survey. (Stewart, Tr. 2531). 

1194. Dr. Stewart’s survey had the simple objective of trying to understand the perceptions 

of consumers with respect biodegradability, what the meaning of the term was, 

complete with any contingencies, dependencies, or context effects that they might 

bring to bear. (Stewart, Tr. 2531). 

1195. “Relevant population” means the group of people to whom the researcher wants to 

extrapolate the results of the survey. (Stewart, Tr. 2532). 

1196. Dr. Stewart defined the relevant population for his survey as adults in the United 

States age 18 and older who indicated that they had some general understanding of 

what the term “biodegradable” means. (Stewart, Tr. 2532). 

1197. Dr. Stewart’s survey’s population also excluded anyone who he thought was 

atypically knowledgeable on the subject of biodegradation. (Stewart, Tr. 2532–33). 

1198. Dr. Stewart chose to exclude from his survey people who indicated that they did not 

have a general understanding of the term “biodegradable” because it makes no sense 

to ask people the meaning of a term when they have already self-identified that they 

do not know what that term means. (Stewart, Tr. 2533). 

1199. If people who had no general understanding of the term “biodegradable” nevertheless 

participated in Dr. Stewart’s survey, they would simply be guessing, offering random 

responses, and not be giving meaningful responses to the survey questions. (Stewart, 

Tr. 2533). 

1200. As a precursor to asking questions that explore more deeply the meaning of a term, 

the first thing a researcher needs to understand is whether people have the basic 

knowledge base necessary to respond to that question. (Stewart, Tr. 2533). 
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1201. If a potential respondent indicates that he or she has no idea what biodegradation 

means, there is no point in asking them a series of questions about something that 

they have already said they do not know anything about. (Stewart, Tr. 2533). 

1202. Screening questions are a set of preliminary questions that are asked at the very 

beginning of a survey to determine whether or not a respondent should receive the 

substantive questionnaire or whether they should be excluded. (Stewart, Tr. 2534). 

1203. Screening questions can be used to assure that a certain variability among respondents 

exists. (Stewart, Tr. 2534). 

1204. An example of a screening question is asking whether a respondent is male or female, 

so that the researcher can assure that the respondents as a whole will be roughly 50% 

male and 50% female. (Stewart, Tr. 2534). 

1205. Screening questions are used for qualifying people and for assuring a more 

representative sample. (Stewart, Tr. 2541). 

1206. Dr. Stewart’s survey included screening questions asking about respondents’ age, 

gender, general employment status, and whether the respondent was knowledgeable 

or not about the term “biodegradable.” (Stewart, Tr. 2535). 

1207. The gender and age screening questions in Dr. Stewart’s survey were designed assure 

that his survey had an adequate number of people of each gender and within each age 

category. (Stewart, Tr. 2535). 

1208. The general employment screening question in Dr. Stewart’s survey was designed to 

eliminate certain kinds of people from participating in the survey, such as people who 

might be atypical in terms of their response, which is very commonly done in survey 

research. (Stewart, Tr. 2535–36). 

1209. Dr. Stewart included the screening question about whether respondents had a general 

knowledge of the term “biodegradable” because it makes no sense to ask people 

about a topic that they self-identify they know little or nothing about, because those 

people would only answer, at best, with guesses and random responses. (Stewart, Tr. 

2536). 

1210. It is a big mistake to have no screening questions in a survey on biodegradation. 

(Stewart, Tr. 2536). 

1211. Without screening questions, the surveyor cannot exclude people that are quite 

atypical and likely to introduce error into the results. (Stewart, Tr. 2537). 

1212. To have no screenings in a survey on biodegradation creates a number of problems 

and calls into question the validity of that survey. (Stewart, Tr. 2537). 

1213. A survey on biodegradation that does not contain screening questions has the 

potential for introducing a lot of error into the survey. (Stewart, Tr. 2537). 
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1214. A survey without screening questions is not capable of being analyzed for the general 

representativeness of the sample. (Stewart, Tr. 2537). 

1215. In the field of survey research, “sampling” means the process by which researchers 

select a subset of individuals from a larger population. (Stewart, Tr. 2538). 

1216. In general, appropriate sampling procedures are designed to assure that the subset that 

researchers select are generally and broadly representative of the larger population. 

(Stewart, Tr. 2538). 

1217. The primary principle to guide the selection of a sample is to create and implement a 

sampling plan that will provide the researcher a representative sample in the sense 

that the sample is like the larger population to whom the researcher wishes to 

extrapolate. (Stewart, Tr. 2538). 

1218. There are important elements of the sampling plan that are important in order to have 

a valid survey. (Stewart, Tr. 2538). 

1219. One important element of a sampling plan is to first clearly define what the relevant 

population is, because without knowing the larger group to which the researcher is 

extrapolating, it is hard to know whether the sample would be representative of the 

relevant population. (Stewart, Tr. 2539). 

1220. Another important element of a sampling plan is the ability to verify how 

representative the same is on at least some key demographic information. (Stewart, 

Tr. 2539). 

1221. Another important element of sampling plans is to assure that the respondents are 

actually capable of answering questions. (Stewart, Tr. 2539). 

1222. Two broad categories of sampling plans exist: probability sampling and 

nonprobability sampling. (Stewart, Tr. 2539–40). 

1223. Probability sampling is sampling where the researcher knows, in advance of actually 

doing the sampling, what the probability of selection of any individual might be. 

(Stewart, Tr. 2539–40). 

1224. Non-probability sampling is where the researcher does not know in advance what the 

probability of selecting any one individual is because a respondent can simply refuse 

to participate in the survey. (Stewart, Tr. 2540). 

1225. Most of the work done by marketing researches involves non-probability samples 

because people can decline to participate in the surveys. (Stewart, Tr. 2540). 

1226. Dr. Stewart’s sample in his survey was a non-probability sample because respondents 

could refuse to participate. (Stewart, Tr. 2541). 
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1227. Dr. Stewart’s survey used a random digit dialing approach so that the telephone 

numbers were randomly selected. (Stewart, Tr. 2541). 

1228. The use of random-digit dialing sampling is one of the things researchers can do to 

assure a more representative sample. (Stewart, Tr. 2541). 

1229. Most business decisions that employ surveys are based on non-probability samples. 

(Stewart, Tr. 2542). 

1230. The sample in Dr. Stewart’s survey was representative. (Stewart, Tr. 2543). 

1231. Dr. Stewart used a sample size of 400 in his survey. (Stewart, Tr. 2544). 

1232. Dt Stewart chose to use 400 as a sample size because it’s near that number that is 

where the researchers reach the point of diminishing returns in terms of sample. 

(Stewart, Tr. 2544). 

1233. With 400 respondents for a simple yes/no question, in the case of the greatest 

variability, the research will be within plus or minus 5 percent of any percent the 

researcher may estimate. (Stewart, Tr. 2545). 

1234. In order to get to plus or minus 3 percent, the researcher needs to triple the size of the 

sample to about 1200 respondents. (Stewart, Tr. 2545). 

1235. Dr. Stewart used two sources to obtain telephone numbers of individuals surveyed in 

his survey. (Stewart, Tr. 2545). 

1236. One source Dr. Stewart used to obtain telephone numbers was Scientific Telephone 

Sampling which is a firm that is in the business of generating samples for survey 

research. (Stewart, Tr. 2545). 

1237. Scientific Telephone Sampling generated a random-digit dialing sample by taking 

listed phone numbers that are publicly available and randomly changing the last two 

digits in order to create a true random sample of telephone numbers in the sense that 

the resulting sample includes unlisted numbers. (Stewart, Tr. 2545–46). 

1238. The APCO survey also used a random-digit dialing sample. (Stewart, Tr. 2546). 

1239. Dr. Stewart also employed an age-enhanced sample that he obtained from Survey 

Sampling, Incorporated which is a company that does preparation, analysis, and 

provision of names and telephone numbers for survey research. (Stewart, Tr. 2546). 

1240. Survey Sampling, Incorporated provided Dr. Stewart with a supplement that included 

a larger percentage of households known to contain younger consumers. (Stewart, 

Tr. 2546). 

1241. Dr. Stewart combined the random-digit dialing sample obtained from Scientific 

Telephone Sampling and the age-enhanced sample from Survey Sampling 
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Incorporated to create the final source of numbers that were used for the dialing his 

survey. (Stewart, Tr. 2546). 

1242. Both Scientific Telephone Sampling and Survey Sampling, Incorporated are wellknown and highly respected providers of sample lists in survey research. (Stewart, 

Tr. 2549). 

1243. Dr. Stewart included screening questions in his survey in order to ensure that the 

respondents surveyed were representative of the relevant population. (Stewart, Tr. 

2551). 

1244. Dr. Stewart established soft quotas for the demographics in his survey to ensure that 

men and women, as well as various age categories, were well represented in the 

survey sample. (Stewart, Tr. 2551). 

1245. In Dr. Stewart’s survey, live interviewers read questions to respondents over the 

telephone. (Stewart, Tr. 2552). 

1246. California Survey Research Services is a well-known firm specializing in telephone, 

mail, and internet surveys that has been in the business of surveys for 30 years. 

(Stewart, Tr. 2552). 

1247. California Survey Research Services does research for a wide range of business, notfor-profit, university, and government organizations. (Stewart, Tr. 2552). 

1248. Dr. Stewart designed the survey, the sampling plan, and the set of questions in his 

survey. (Stewart, Tr. 2552). 

1249. After California Survey Research Services programmed Dr. Stewart’s survey into 

CATI system, Dr. Stewart viewed the questionnaire through a link and, after 

reviewing it, Dr. Stewart approved the survey. 

1250. California Survey Research Services employs multiple layers of supervision when 

implementing a survey. (Stewart, Tr. 2553). 

1251. Dr. Stewart assured that the design of his survey was double blind. (Stewart, Tr. 

2553). 

1252. “Double blind” means that the interviewers and any of other personnel directly 

involved with collecting or coding the data were not aware of the sponsor or purpose 

of the research, nor were the respondents aware of either the purpose or the sponsor 

of the research. (Stewart, Tr. 2553–54). 

1253. Where a survey is double-blind, it is unlikely that a respondent or interviewer will 

seek to be helpful by offering a response that they think is consistent with what the 

researcher is looking for. (Stewart, Tr. 2554). 
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1254. A survey that is not double-blind calls into question the validity of that survey. 

(Stewart, Tr. 2554). 

1255. California Survey Research Services coded the responses to Dr. Stewart’s survey. 

(Stewart, Tr. 2554). 

1256. It would have been problematic for Dr. Stewart to code the answers to his survey 

because the mere fact that he knew the purpose of the research could influence how 

he coded the data. (Stewart, Tr. 2555). 

1257. In Dr. Stewart’s survey, disagreements between coders were resolved by the coders 

getting together, comparing notes, and attempting to resolve their differences. 

(Stewart, Tr. 2556). 

1258. Blinding of coders is very important when coding open-ended questions because the 

coders are, in effect, transforming the data into categories of responses. (Stewart, Tr. 

2557). 

1259. To the degree that the coders have a prior understanding of what the researcher is 

looking for, that prior understanding can influence what codes the coders arrive at and 

how they code the data. (Stewart, Tr. 2557). 

1260. All of the interviewers who implemented Dr. Stewart’s were trained in general 

interviewing technique and also were specifically trained to the protocol that was 

used in Dr. Stewart’s survey. (Stewart, Tr. 2558). 

1261. Supervisory personnel trained the interviewers, answered the interviewers’ questions, 

were on-site at the time the interviewing took place, and could therefore address any 

problems that arose during the survey. (Stewart, Tr. 2558–59). 

1262. Supervisory personnel also had the ability to randomly monitor the interviewing as it 

was taking place in real time, so that they could determine whether the interview was 

actually taking place and whether the protocol was actually being followed. (Stewart, 

Tr. 2559). 

1263. The mere fact that supervisory personnel were able to listen to interviews in real time 

at will assures a higher degree of integrity and attention to instructions among the 

interviewers. (Stewart, Tr. 2559). 

1264. The interviewers had an opportunity for debriefing to discuss any questions, 

problems, or issues that arose after they completed a practice interview. (Stewart, Tr. 

2560). 

1265. Interviewers’ ability to participate in briefing ensures a higher quality and efficiency 

of the interviewing process and acts as a way to standardize the interviewers. 

(Stewart, Tr. 2560). 
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1266. Dr. Stewart’s main questionnaire used primarily open-ended questions. (Stewart, Tr. 

2561). 

1267. By allowing respondents to answer the survey questions in their own words, Dr. 

Stewart was able to identify any qualifications, dependencies, and contexts that might 

be present in a respondent’s answer. (Stewart, Tr. 2562). 

1268. It would have been a mistake for Dr. Stewart not to use a screen questionnaire in his 

survey for two reasons. (Stewart, Tr. 2562). 

1269. First, without a screener questionnaire it is not possible for a researcher to obtain 

accurate demographic information and therefore the researcher has no way to verify 

the degree to which the sample was generally representative of the larger population. 

(Stewart, Tr. 2562). 

1270. Second, the absence of a screener prevents a researcher from eliminating people who 

were atypical. (Stewart, Tr. 2562). 

1271. The coders in Dr. Stewart’s survey reviewed the responses to the open-ended 

questions to determine the broad categories that would seem to capture the responses. 

(Stewart, Tr. 2565). 

1272. The categories that best captured respondents’ responses to open-ended questions in 

Dr. Stewart’s survey became the code book. (Stewart, Tr. 2564–65). 

1273. Dr. Stewart approved the code book. (Stewart, Tr. 2565). 

1274. Dr. Stewart survey contained a main questionnaire which is the same as the 

substantive questionnaire. (Stewart, Tr. 2566). 

1275. The main questionnaire in Dr. Stewart’s survey answered the question of what the 

relevant population understands the meaning of the term “biodegradable” to mean. 

(Stewart, Tr. 2566). 

1276. Dr. Stewart’s main questionnaire used the funnel approach, which starts with general 

open-ended questions and progresses to more specific open-ended questions, and 

finally some closed-ended questions. (Stewart, Tr. 2566). 

1277. Leading questions, questions which both suggest an answer and ask a question, are 

not appropriate. (Stewart, Tr. 2567). 

1278. None of the questions in Dr. Stewart’s survey were leading. (Stewart, Tr. 2568). 

1279. Dr. Stewart’s screener questionnaire contained six questions, and his main 

questionnaire contained about 15 questions. (Stewart, Tr. 2569). 

1280. Not every respondent was asked every question in Dr. Stewart’s main questionnaire. 

(Stewart, Tr. 2569). 
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1281. If a respondent disconnected the phone call during the survey, that respondent’s 

answers were not counted and that respondent was recorded as a “terminate.” 

(Stewart, Tr. 2569–70). 

1282. Asking a respondent only one question in a survey on the meaning of 

“biodegradable” does not allow a researcher to get a rich understanding of how a 

respondent actually understands “biodegradable.” (Stewart, Tr. 2570). 

1283. In Dr. Stewart’s survey, 19% of respondents were aged 18–34, 23% of respondents 

were aged 35–49, 29% percent of respondents were aged 50–65, and 29% of 

respondent were aged 66 and older. (Stewart, Tr. 2572; RX 605). 

1284. In Dr. Stewart’s survey, 201 respondents were female and 199 respondents were 

male. (Stewart, Tr. 2572; RX 605). 

1285. Dr. Stewart’s respondents are broadly representative. (Stewart, Tr. 2572). 

1286. Dr. David Stewart, a survey expert whose work has repeatedly been credited by ALJs 

of the FTC and the Commission itself, designed a telephone survey in order to 

determine how consumers who actually purchase products made from or packaged in 

plastic perceive the meaning of the term “biodegradability.” (Stewart, Tr. 2493–94, 

2505–09; RX 856 (Stewart, Rep. at 15)). 

1287. Dr. Stewart’s survey also assessed the message that consumers take away from claims 

made by ECM. (RX-856 (Stewart, D., Expert Report at 15)). 

1288. Dr. Stewart’s survey used well-designed, non-leading, and clear open-ended 

questions that allowed real consumers to answer in their own words and to provide 

qualifications, contextual information, or other information that established a richer 

meaning of consumer responses than is typically obtained when only closed-ended 

questions appear (or single questions are posed without human interface) in a survey. 

(Stewart, Tr. 2526–27; RX 856 (Stewart, Rep. at 15)). 

1289. Dr. Stewart designed and conducted his survey in accordance with well-established 

principles of survey research offered in litigation, as articulated in the Manual for 

Complex Litigation. (Stewart, Tr. 2522; RX 856 (Stewart, Rep. at 16)). 

1290. The interviewers and their supervisors for Dr. Stewart’s survey were blind in the 

sense that they did not know for whom the survey was being conducted. (Stewart, Tr. 

2553–54; RX 843 (Stewart Dep. at 276)). 

1291. Once the respondents were appropriately selected from a list of telephone numbers 

based on an algorithm employed by the CATI system, interviewers clarified to 

potential respondents that the call was for research purposes and not telemarketing. 

(RX 856 (Stewart, Rep. at 19)). 

1292. The screener questions in Dr. Stewart’s survey ensured that the respondent was over 

18, asked their age and gender to ensure that appropriate diversity was represented 
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within the sample, ensured that they or anyone in their household did not work for a 

manufacturer of plastic products or a waste disposal organization, ensured that they 

had purchased a product in a plastic container or containing plastic within the past 

month, and ensured they had a general understanding of the term biodegradable. 

(Stewart, Tr. 2532–33, 2535–36; RX 856 (Stewart, Rep. at 19–20)). 

1293. All but two of the questions in Dr. Stewart’s main questionnaire were open-ended 

questions, which have the advantage of allowing respondents to offer answers that are 

qualified, provide context, or are otherwise nuanced, and which are useful for 

clarifying terminology by gauging the meanings of words and for informing 

variability among respondents. (RX 856 (Stewart, Rep. at 20)). 

1294. The first few questions in Dr. Stewart’s survey asked respondents about their 

perceptions of biodegradability generally. (RX 856 (Stewart, Rep. at 21)). 

1295. For example, Q4 in Dr. Stewart’s survey asked, “If something is biodegradable, how 

long do you think it would take for it to decompose or decay?” (RX 856 (Stewart, 

Rep. at 21)). 

1296. The next set of questions in Dr. Stewart’s survey asked the respondents to indicate in 

their own words what claims adapted from claims used by ECM mean to them. (RX 

856 (Stewart, Rep. at 21)). 

1297. The field work for Dr. Stewart’s survey cost $37,500. (Stewart, Tr. 2648; RX-856 

(Stewart, Rep. at 23)). 

1298. Dr. Stewart’s survey was pre-tested by conducting a small pilot project, which 

confirmed that no changes to the survey design were necessary. (RX 856 (Stewart, 

Rep. at 23)). 

1299. All verbatim responses to Dr. Stewart’s survey were coded independently by two 

coders and any disagreements were resolved in discussion. (Stewart, Tr. 2556–57; RX 

856 (Stewart Rep. at 23)). 

1300. Ninety-eight percent of the respondents to Dr. Stewart’s survey believe that different 

types of products biodegrade, decompose, or decay at different rates. (Stewart, Tr. 

2577). 

1301. Ninety-eight percent of the respondents to Dr. Stewart’s indicated that they would 

have to qualify any answer about the amount of time it would take for something to 

biodegrade based on the material. (Stewart, Tr. 2577). 

1302. Ninety-eight percent of the respondents to Dr. Stewart’s do not believe that there is a 

uniform rate for materials biodegrading and that the rate really depends on the 

material. (Stewart, Tr. 2577). 

1303. Consumers have a very nuanced understanding of biodegradability. (Stewart, Tr. 

2579). 
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1304. Consumers understand that the process of biodegradation is one that can vary quite 

substantially depending on the material, the context, where the item is disposed of, 

and the size of the product. (Stewart, Tr. 2579). 

1305. Consumers believe that the word “biodegradable” means to decay or destruct, and 

believe in general terms that the process of biodegradation is one whereby the product 

breaks down in some way. (Stewart, Tr. 2579). 

1306. The most common response, by far, to the question “[i]f something is degradable, 

how long do you think it would take for it to decompose or decay?” in Dr. Stewart’s 

survey was that “it depends on the material or type of product. “ (Stewart, Tr. 2580). 

1307. The most common response that provided a clear time period to the question “[i]f 

something is degradable, how long do you think it would take for it to decompose or 

decay?” was one to five years, given by 6% of respondents. (Stewart, Tr. 2580). 

1308. Any answer to the question “[i]f something is degradable, how long do you think it 

would take for it to decompose or decay?” in Dr. Stewart’s survey must be put into 

the context of the other questions in his survey because we know that 98% of 

respondents believe that the type of material makes a difference in the rate of 

biodegradation. (Stewart, Tr. 2581; RX 856 (Stewart, Rep. at 26)). 

1309. If the interviewers in Dr. Stewart’s survey probed the respondents who gave a clear 

time frame in response to the question “[i]f something is degradable, how long do you 

think it would take for it to decompose or decay?”, the data would likely have 

detected dependencies, contextual effects, and differences among materials. (Stewart, 

Tr. 2581). 

1310. There is a wide array of differences amongst respondents about how long a 

degradable object takes to decompose or decay. 

1311. There is great agreement, 98%, that the amount of time something takes to degrade 

depends upon factors such as the material, the context, and the environment. 

(Stewart, Tr. 2581; RX 856 (Stewart, Rep. at 26)). 

1312. Not one respondent to Dr. Stewart’s survey understood biodegradation to mean the 

complete breakdown of the substance into elements in nature within one year after 

customary disposal. (Stewart, Tr. 2583). 

1313. The fact that consumers may hold a mistaken belief about how long something takes 

to biodegrade does not mean that that mistaken belief was attributable the action of 

any marketer, including ECM. (Stewart, Tr. 2584–85). 

1314. Dr. Stewart’s survey presented three claims three of ECM’s stylized claims to 

respondents. (Stewart, Tr. 2585). 

1315. Americans have a shared understanding of the word “biodegradable” to the extent 

that it means to break down. (Stewart, Tr. 2586). 
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1316. Americans have a shared understanding that the amount of time required for 

biodegradation depends on characteristics like type of material and environment. 

(Stewart, Tr. 2586). 

1317. Americans do not hold a shared belief as to the amount of time a biodegradable 

substance takes to biodegrade. (Stewart, Tr. 2586). 

1318. No significant minority of Americans define “biodegradation” to mean that a product 

will completely biodegrade into elements in nature within one year after customary 

disposal. (Stewart, Tr. 2586). 

1319. Dr. Stewart’s survey is highly reliable. (Stewart, Tr. 2587). 

1320. Dr. Stewart’s survey was designed in a fashion that is very consistent with accepted 

standards and best practices in the design of survey research. (Stewart, Tr. 2587). 

1321. Dr. Stewart’s survey has a representative sample on key demographic characteristics. 

(Stewart, Tr. 1587), 

1322. Because 98% of the respondents to Dr. Stewart’s survey believe that the amount of 

time something takes do decompose varies, even if the survey’s demographics are 

wrong by some percent, the vast majority of Americans still share the belief that the 

amount of time it takes for something to biodegrade varies based on the material, size, 

and context in which biodegradation occurs. (Stewart, Tr. 2587). 

1323. Dr. Stewart conducted a pilot survey of manufacturers of plastic. (Stewart, Tr. 2587). 

1324. For the manufacturers’ survey, ECM provided a customer list to Dr. Stewart that 

included names and telephone numbers of individuals that were identified as most 

knowledgeable about the manufacture of plastics and the components that would be 

acquired for that process. (Stewart, Tr. 2588). 

1325. California Survey Research Services implemented the pilot survey of manufacturers 

of plastic by using a telephone survey with professional interviews using a CATI 

system. (Stewart, Tr. 2588–89). 

1326. The pilot survey had a limit of 20 hours of calling. (Stewart, Tr. 2588). 

1327. In those 20 hours, California Survey Research Services was able to complete surveys 

with 10 companies. (Stewart, Tr. 2588). 

1328. The pilot survey indicated that there is variability in perceptions of biodegradation 

even amongst the sophisticated ECM purchasers. (Stewart, Tr. 2588). 

1329. The pilot survey was conducted in accordance with the principles necessary for a 

sound survey. (Stewart, Tr. 2589–90). 
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1330. The pilot survey indicated that the respondents appear to be more knowledgeable of 

particular standards or of the Green Guides than the typical consumer. (Stewart, Tr. 

2590). 

1331. Dr. Stewart’s survey first concluded that while consumers do have a conceptual 

understanding of what biodegradability is, that understanding is not material to any 

sizable minority of consumers. (RX 856 (Stewart, Rep. at 24)). 

1332. Dr. Stewart’s survey also concluded that 68% of the respondents recognize 

differences in the rate of decomposition depending on the type of material or the 

context. (RX 856 (Stewart, Rep. at 25)). 

1333. The results also made very clear that the vast majority of consumers have an 

understanding that the process of biodegradability is highly varied and that it is not 

often a rapid process. (Stewart, Tr. 2814; RX 856 (Stewart, Rep. at 25–26)). 

1334. Ninety-eight percent of respondents to Dr. Stewart’s survey believe that different 

types of products take different amounts of time to biodegrade, decompose, or decay. 

(Stewart, Tr. 2577; RX 856 (Stewart, Rep. at 26)). 

1335. Such differences, according to the respondents, include the type or size of the 

material, the context, or the environment. (Stewart, Tr. 2577–78; RX-856 (Stewart, 

Rep. at 26)). 

1336. Consumers recognize significant time variances in decomposition, and that there is 

little evidence that their understanding of the term biodegradability is restricted to 

decomposition processes that occur within one year or less. (RX 856 (Stewart, Rep. at 

26)). 

1337. As for the questions in Dr. Stewart’s survey which incorporated ECM’s claims made 

to industrial purchasers, Dr. Stewart found that a common response included a lack of 

understanding, expressions of confusion, expressions of skepticism or disbelief, or a 

simple restatement of the claim. (RX 856 (Stewart, Rep. at 26)). 

1338. Dr. Stewart concluded that “this lack of understanding, confusion, and skepticism 

make it highly unlikely that [ECM’s] claims would be material” to an end use 

consumer, even if these claims were directed right at the end use consumer. (RX 856 

(Stewart, Rep. at 26)). 

1339. Dr. Stewart’s further concluded that two of three criteria required for a finding of 

deception, a false belief attributable to actions of the marketer and that the claim be 

material to consumers, are not present in ECM’s alleged advertising. (RX 856 

(Stewart, Rep. at 27)). 

1340. Dr. Stewart also conducted a limited Manufacturers Pilot Survey in an attempt to 

ascertain whether more knowledgeable purchasers have a more common 

understanding of biodegradability. (Stewart, Tr. 2578; RX 56 (Stewart, Rep. at 27–

28)). 
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1341. ECM provided Dr. Stewart a list of representatives from customer organizations who 

were involved in the purchase of materials for the manufacturer of plastics. (RX 856 

(Stewart, Rep. at 27)). 

1342. Representatives from 10 of ECM’s customers participated in the pilot survey of 

manufacturers of plastic, which was also implemented by CSRS. (RX 856 (Stewart, 

Rep. at 26–27)). 

1343. The pilot survey of manufacturers of plastics concluded that even among these more 

knowledgeable and sophisticated customers there is substantial variation in opinions 

about how quickly a biodegradable product should take to decompose. (Stewart, Tr. 

2590; RX 856 (Stewart, Rep. at 27)). 

1344. The reason the pilot survey of manufacturers of plastics was not developed into a fullblown study is because the respondents were people who were difficult to contact, 

and in 20 hours of interviewing time, CSRS was only able to conduct interviews of 10 

respondents. (Stewart, Tr. 2806). 

IX. ECM ACCURATELY DEFINED “BIODEGRADABILITY” IN ITS MATERIALS 

GIVEN TO CONSUMERS 

1345. ECM issues a certificate of biodegradability to its customers once they have 

completed product trials and signed a letter of assurance. (Sinclair, Tr. 783).

1346. The letter of assurance states that they understand the manufacturing process of their 

plastics with the additive, they understand the additive must be loaded at a minimum 

of one percent (1%) by weight, and that failing to meet the load rate requirement may 

endanger the biodegradability of their plastic. (Sinclair, Tr. 783).

1347. Every ECM certificate of biodegradability includes the ASTM definition of 

“biodegradability.” (Sinclair, Tr. 783–84; CCX 14).

1348. The ASTM D883-12 definition of biodegradability is:

"A degradable plastic is defined as a plastic that is designed to 

undergo a significant change in its chemical structure under 

specific environmental conditions resulting in a loss of some 

properties that may vary as measured by standard test methods 

appropriate to the plastic and the application in a period of time 

that determines its classification. A Biodegradable Plastic is 

defined as a degradable plastic in which the degradation results 

from the action of naturally occurring microorganisms such as 

bacteria, fungi and algae.” 
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(Sinclair, Tr. 785; CCX 14). 

1349. ECM provides a “certificate of biodegradability” to each of its customers. (Sinclair, 

Tr. 783). 

1350. ECM’s certificate of biodegradability defines biodegradability. (Sinclair, Tr. 784; 

CCX 14). 

1351. ECM’s certificate of biodegradability defines a degradable plastic in the same way as 

biodegradability is defined in ASTM D883-12. (Sinclair, Tr. 785; CCX 14). 

1352. ECM’s certificate of biodegradability defines a degradable plastic “as a plastic that is 

designed to undergo a significant change in its chemical structure under specific 

environmental conditions resulting in a loss of some properties that may vary as 

measured by standard test methods appropriate to the plastic and the application in a 

period of time that determines its classification. A Biodegradable plastic is defined as 

a degradable plastic in which the degradation results from the action of naturally 

occurring microorganisms such as bacteria, fungi, and algae.” (Sinclair, Tr. 785; 

CCX 14). 

X. DR. MCCARTHY IS BIASED, INCONSISTENT, AND NOT CREDIBLE 

1353. Dr. McCarthy’s Ph.D. is in macromolecular science, and not polymer engineering. 

(McCarthy, Tr. 480–81). 

1354. Dr. McCarthy does not have a graduate level degree in organic polymer chemistry. 

(McCarthy, Tr. 481).

1355. Dr. McCarthy is not a biochemist. (McCarthy, Tr. 481). 

1356. Dr. McCarthy does not know about all biochemical interactions. (McCarthy, Tr. 

482). 

1357. Dr. McCarthy is not a microbiologist. (McCarthy, Tr. 482). 

1358. Dr. McCarthy is not expert in the kinds of microorganisms that dwell in a landfill. 

(McCarthy, Tr. 482). 

1359. Dr. McCarthy is not an expert in the colonization of microorganisms that form in 

landfills. (McCarthy, Tr. 482). 

1360. Dr. McCarthy’s expert report was the result of a collaborative effort between Dr. 

McCarthy and Complaint Counsel. (McCarthy, Tr. 482–83). 
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1361. When Dr. McCarthy was asked “can you identify for me the content in footnote 1 that 

you yourself drafted?” He stated “probably the scientific definition part of it.” 

(McCarthy, Tr. 487). 

1362. When asked if he drafted “any other part of [footnote 1]?” Dr. McCarthy said “no.” 

(McCarthy, Tr. 487). 

1363. In his expert report, Dr. McCarthy defines “biodegradable” as “mean[ing] that the 

entire treated plastic will completely break down and return to nature (i.e., decompose 

into elements found in nature) within one year after customary disposal (i.e., 

incinerator, landfill or recycling.” (McCarthy, Tr. 484–86; CCX 891 (McCarthy, 

Rep. at 5 n. 1)). 

1364. When asked if “Complaint Counsel asked [him] to use this definition?” Dr. McCarthy 

replied “Yeah. With regard to the marketing claim.” (McCarthy, Tr. 485). 

1365. When asked “is it true that you take the position that this is a scientific definition, that 

is, the definition in footnote 1?” Dr. McCarthy replied “they’re equivalent.” 

(McCarthy, Tr. 486). 

1366. When asked if the “definition in footnote 1 is interchangeable with the scientific 

definition of ‘biodegradable,’” Dr. McCarthy responded “yeah.” (McCarthy, Tr. 487; 

CCX 891 (McCarthy, Rep. at 5 n. 1)). 

1367. When asked if “under [his] expert report footnote 1 definition of the term 

‘biodegradable,’ if 365 days after customary disposal, 99 percent of a treated plastic 

has completely broken down and returned to nature... but 1 percent remains, the 

treated plastic is not biodegradable, is it?” Dr. McCarthy replied “for that unqualified 

marketing claim.” (McCarthy, Tr. 495-96). 

1368. When further asked “but you said it’s interchangeable with the scientific definition, 

right?” Dr. McCarthy stated “actually, I believe I would like to change that.”

(McCarthy, Tr. 496) (emphasis added). 

1369. Dr. McCarthy explained this desire to change his footnote 1 definition: “Yeah. 

Because it would – it was – ‘interchangeable’ I think is a bit strong.” (McCarthy, Tr. 

496). 

1370. Dr. McCarthy then stated that the footnote 1 definition was “just for one of the 

claims. That was just the first one of the claims.” (McCarthy, Tr. 497). 

1371. When asked “but isn’t it the case that in footnote 1 you indicate that that’s the 

definition that you’re going to abide by in your expert report?” Dr. McCarthy admits 

“that’s what it says, yeah.” (McCarthy, Tr. 497). 

1372. Dr. McCarthy has defined the term “biodegradable” or “biodegradation” in articles he 

has authored. (McCarthy, Tr. 487–88). 
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1373. When Dr. McCarthy has defined the “biodegradable” or “biodegradation” in articles 

he has authored, that definition has always been different than the definition he used 

in his expert report. (McCarthy, Tr. 488). 

1374. Dr. McCarthy authored a chapter entitled “Biodegradable Polymers” in the text 

entitled “Plastics and the Environment.” (McCarthy, Tr. 489; RX 924). 

1375. In his chapter entitled “Biodegradable Polymers,” Dr. McCarthy stated that “[t]he 

definition of biodegradable polymer varies greatly among scientists, manufacturers, 

and consumers.” (McCarthy, Tr. 489–90; RX 924). 

1376. No definition Dr. McCarthy has ever used in published scientific literature included a 

requirement that plastic completely break down and return to nature within one year 

of customary disposal in a landfill. (McCarthy, Tr. 494). 

1377. The ASTM does not define biodegradable to mean that there will be a complete 

breakdown and return to nature of the treated plastic within one year after customary 

disposal. (McCarthy, Tr. 494). 

1378. As of 2003, the ASTM defined “biodegradable plastic” as a “plastic designed to 

undergo a significant change in its chemical structure under specific environmental 

conditions resulting in a loss of some properties ... in which the degradation results 

from the action of naturally-occurring micro-organisms such as bacteria, fungi, and 

algae.” (McCarthy, Tr. 494–95; RX 924). 

1379. In scientific articles, Dr. McCarthy has described plastic as “biodegradable” when it 

biodegraded, in Dr. McCarthy’s own tests, to far less than one hundred percent. 

(McCarthy, Tr. 499). 

1380. According to Dr. McCarthy, a banana is biodegradable. (McCarthy, Tr. 506). 

1381. According to Dr. McCarthy, a tree trunk is biodegradable. (McCarthy, Tr. 508–09). 

1382. Dr. McCarthy is the editor of the Journal of Polymers and the Environment, formerly 

the Journal of Polymer Degradation. (McCarthy, Tr. 509). 

1383. Dr. McCarthy evaluates the scientific merits of articles published in the Journal of 

Polymers and the Environment. (McCarthy, Tr. 510). 

1384. Dr. McCarthy decides which articles are published in the Journal of Polymers and the 

Environment. (McCarthy, Tr. 511). 

1385. No article would appear in the Journal of Polymers and the Environment without Dr. 

McCarthy’s approval. (McCarthy, Tr. 513). 

1386. Dr. McCarthy edits and determines which articles are published in the Journal of 

Polymers and the Environment. (McCarthy, Tr. 527). 
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1387. Dr. McCarthy reviewed an article entitled “Biodegradable Polymers-A Review on 

Recent Trends and Emerging Perspectives” that was published in the Journal of 

Polymers and the Environment in June of 2011. (McCarthy, Tr. 511–12; RX 925). 

1388. In “Biodegradable Polymers-A Review on Recent Trends and Emerging 

Perspectives,” published in the Journal of Polymers and the Environment, the authors 

state that “[t]he various definitions of biodegradation depend on the field of 

application of the polymers (biomedical area or natural environment). Many different 

definitions have officially been adopted, depending on the background of the defining 

standard organizations and their particular interests.” (McCarthy, Tr. 527–28; RX 

925). 

1389. In “Biodegradable Polymers-A Review on Recent Trends and Emerging 

Perspectives” the authors list a serious of sources for the definition of 

“biodegradable” and “biodegradation” that are within the universe of biomedical and 

the natural environment literature. (McCarthy, Tr. 528; RX 925). 

1390. Dr. McCarthy, even though he evaluated the scientific merits of “Biodegradable 

Polymers-A Review on Recent Trends and Emerging Perspectives” before allowing it 

in the Journal of Polymers and the Environment, did not ask the authors of that article 

to include with the definition of biodegradation the requirement that the plastic 

completely break down and return to nature within one year of customary disposal. 

(McCarthy, Tr. 529). 

1391. No reviewer who reviewed “Biodegradable Polymers-A Review on Recent Trends 

and Emerging Perspectives” prior to publication changed the content of the article to 

require it to include that plastic will completely break down and return to nature 

within one year of customary disposal. (McCarthy, Tr. 529). 

1392. During his deposition, Dr. McCarthy testified that a product that biodegraded 95 

percent in 364 days would not satisfy the definition of biodegradable Dr. McCarthy 

uses in his expert report. (McCarthy, Tr. 525–26; RX 841 (McCarthy, Dep. at 28)). 

1393. According to Dr. McCarthy, a product that biodegraded by 95 percent in 365 days, 

and 100 percent in 366 days is not biodegradable under the definition he uses in his 

expert report. (McCarthy, Tr. 526). 

1394. At hearing, when asked “who makes the determination of whether [an article] is 

accepted for publication?” Dr. McCarthy testified: “the referees.” (McCarthy, Tr. 

526). 

1395. However, at deposition, when asked the same question, Dr. McCarthy testified to the 

contrary, stating: “it would be my decision, but it would be based on reviews.” 

(McCarthy, Tr. 526–27; RX 841 (McCarthy, Dep. at 38)). 

1396. Dr. McCarthy has accepted, on behalf of UMass, millions of dollars in funding from 

ECM competitors that offer bioplastics and compostable products. (CCX 891 

(McCarthy, Rep. at 42–44)). 
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1397. Some polymer blends which Dr. McCarthy invented are the subject of a United States 

patent, patent number 5,883,199. (McCarthy, Tr. 534–35; RX 928). 

1398. Dr. McCarthy has directly profited from research he performed for ECM competitors, 

receiving $4,000-$5,000 per year in royalties from a patent he invented that is 

licensed to Metabolix, an ECM competitor. (McCarthy, Tr. 523–24; RX 841 

(McCarthy, Dep. at 60)). 

1399. UMass is patent number 5,883,199’s assignee. (RX 761; RX 757). 

1400. Dr. McCarthy directly profits from compostable plastic resin patent royalties paid to 

UMass. (McCarthy, Tr. 524). 

1401. Metabolix Corporation is the exclusive licensee of a patented biodegradable polymer 

that Dr. McCarthy invented. (McCarthy, Tr. 523;RX 209; RX 928). 

1402. Metabolix’s potential royalties from licensing UMass patents surpass $100,000 per 

year. (RX 209). 

1403. Dr. McCarthy receives royalties from the patent he invented for which Metabolix 

Corporation is the exclusive licensee. (McCarthy, Tr. 524). 

1404. As of the date of the hearing, Dr. McCarthy had received about $28,000.00 in 

royalties as a result of the patent he invented for which Metabolix Corporation is the 

exclusive licensee. (McCarthy, Tr. 524, 612). 

1405. To the extent Metabolix’s sales increase based on incursions into ECM’s market, 

royalties from the patent will increase and Dr. McCarthy’s income from those 

royalties will increase as well. (McCarthy, Tr. 524; RX 841 (McCarthy, Dep. at 51–

52, 55–61)). 

1406. Dr. McCarthy has appeared as an expert for Metabolix Corporation twice. 

(McCarthy, Tr. 523-24). 

1407. UMass-Lowell has boasted of Dr. McCarthy’s income earning potential, noting in 

2012 that Dr. McCarthy “has obtained nearly $9 million in externally sponsored 

research grant and contracts, plus nearly $33 million in intellectual property donations 

to UMass Lowell.” (Aguirre, “Plastics Engineering Educator Praised for Research, 

Service” (Sep. 21, 2012), available at http://www.uml.edu/News/stories/2011-

12/University-Professor-reception.aspx). (McCarthy, Tr. 530-532). 

1408. Under an agreement with the University and in accordance with UMass policy, Dr. 

McCarthy assigned his patent rights in a compostable plastic resin he invented to 

UMass. (McCarthy, Tr. 523–24; RX 841 (McCarthy, Dep. at 57)). 

1409. In exchange, Dr. McCarthy receives a 10% profit share of the royalty stream. 

(McCarthy, Tr. 523–24, 535; RX 841 (McCarthy, Dep. at 59)). 
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1410. The intention of patent number 5,883,199 is to produce compostable products. 

(McCarthy, Tr. 536). 

1411. The companies which Metabolix Corporation sublicense patent number 5,883,199 to, 

such as BASF and NatureWorks, produce resin that is used in compostable products. 

(McCarthy, Tr. 536). 

1412. Dr. McCarthy acknowledged that Metabolix’s products compete directly with ECM’s 

technology for market share. (McCarthy, Tr. 538–408; RX 841 (McCarthy, Dep. 64–

66)). 

1413. For years ECM’s competitors, such as Metabolix, have directly lobbied FTC 

attorneys to pursue enforcement action against additive companies, including ECM. 

(RX 211). 

1414. Since 2008, Metabolix has also been lobbying the FTC to act against ECM. (RX 

211). 

1415. Metabolix is also a member of the Biodegradable Products Institute (“BPI”), a 

primary ECM competitor, and sells approximately a dozen products that are “BPI 

certified” in direct competition with ECM. (McCarthy, Tr. 564; RX 171; RX 172). 

1416. Groups like the BPI, and scientists affiliated with same, zealously lobbied the ASTM 

to incorporate limited language in biodegradability test standards that would 

(unscientifically) limit claim language based on test results. (RX 741). 

1417. Representatives from BPI had open channels to FTC attorneys and frequently 

reported marketing claims by additive companies, such as ECM and ECM’s 

customers. (RX 718–RX 733).

1418. BPI not only lobbied in favor of regulations that would hurt the biodegradable plastic 

additive industry, but it also told customers that ECM plastics are not truly 

biodegradable according to their standards of testing. (RX 124). 

1419. BPI harshly and publicly criticized biodegradable additive manufacturers, naming 

ECM specifically. (RX 125). 

1420. Many companies that have funded Dr. McCarthy’s UMass Lowell Bioplastics and 

Medical Plastics Research Center, such as Cargill and Eastman Chemical, are 

members of the BPI. (McCarthy, Tr. 531; RX 169). 

1421. The BPI has hired Dr. McCarthy to be a compostable product certifier. (McCarthy, 

Tr. 564). 

1422. From 2001 through 2011, Dr. McCarthy was paid by the BPI one thousand dollars for 

each of about thirty certification examinations he completed. (McCarthy, Tr. 564). 
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1423. At the hearing and at his deposition, Dr. McCarthy testified that his determination 

would result in either a certification or not certified determination. (McCarthy, Tr. at 

564–65; RX 841 (McCarthy, Dep. at 93)). 

1424. If Dr. McCarthy certified a company as compostable, that company was then allowed 

to place a logo or other form of certification on its products. (McCarthy, Tr. 565–66). 

1425. At the hearing, when asked what that certification or logo provides, Dr. McCarthy 

testified: “I don’t know.” (McCarthy, Tr. 566). 

1426. However, at deposition, when asked the same question, Dr. McCarthy testified 

differently: “[i]t provides a certification that it meets the standards of the D6400” and 

that it is “compostable.” (McCarthy, Tr. 566; RX 841 (McCarthy, Dep. at 94)). 

1427. Metabolix supplied grants to UMass of approximately $2.5 million, sponsored more 

than 50 students for their master’s and doctorate degrees, and has made substantial 

equipment donations (over $500,000) to UMass Lowell. (RX 210). 

1428. Dr. McCarthy is the director of the UMass Lowell Bioplastics and Medical Plastics 

Research Center. (McCarthy, Tr. 529–30). 

1429. Companies that have sponsored research at the UMass Lowell Bioplastics and 

Medical Plastics Research Center include ICI, Monsanto, National Starch, Eastman, 

Warner-Lambert, Bristol-Myers Squibb, Johnson & Johnson, Metabolix, BASF, and 

Cargill, the U.S. Army, EcoVerde, 3M Company, and Densified Solutions. 

(McCarthy, Tr. 531). 

1430. Metabolix Corporation essentially leased storage space from UMass Lowell. 

(McCarthy, Tr. 599–601; RX 962). 

1431. Metabolix Corporation donated an air compressor to UMass Lowell in order to offset 

costs incurred by the university. (McCarthy, Tr. 602–03; RX 963). 

1432. If Metabolix goes out of business, Dr. McCarthy hopes that the university would 

license patent number 5,883,199 to another institution. (McCarthy, Tr. at 606). 

1433. Metabolix has paid up to $200,000 per year to UMass-Lowell for fee-for-service 

projects. (McCarthy, Tr. 612–13). 

1434. Metabolix has paid the most money to the UMass Lowell Bioplastics and Medical 

Plastics Research Center. (McCarthy, Tr. 531). 

1435. Metabolix has paid approximately one and a half million dollars in grants to Dr. 

McCarthy’s university. (McCarthy, Tr. 531–32). 

1436. Metabolix has also reimbursed UMass Lowell for equipment purchased by UMass 

Lowell which Metabolix wanted to use. (McCarthy, Tr. 532). 
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1437. Metabolix employees have worked alongside Dr. McCarthy and his students at the 

UMass Lowell Bioplastics and Medical Plastics Research Center. (McCarthy, Tr. 

532, 608–09). 

1438. Dr. McCarthy’s students are available to Metabolix to work for Metabolix as 

requested by Metabolix to Dr. McCarthy’s secretary. (McCarthy, Tr. 532, 608–09). 

1439. When Dr. McCarthy’s students are working for Metabolix, Metabolix has an 

employee that oversees Dr. McCarthy’s students to ensure that the conditions of the 

work being performed by Dr. McCarthy’s students are the conditions that Metabolix 

wants. (McCarthy, Tr. 533). 

1440. The Metabolix employees take notes and give advice to Dr. McCarthy’s students 

while Dr. McCarthy’s students perform the work required by Metabolix. (McCarthy, 

Tr. 533). 

1441. When Dr. McCarthy’s students are performing the work requested by Metabolix, Dr. 

McCarthy’s students are being paid indirectly by Metabolix. (McCarthy, Tr. 533–

34). 

1442. Students at UMass Lowell use UMass Lowell equipment for services for Metabolix. 

(McCarthy, Tr. 604). 

1443. At the hearing, when asked whether “the products made under the ‘199 patent that are 

on the market are plastic compost bags, right?” Dr. McCarthy testified: “I’m not 

sure.” (McCarthy, Tr. 536). 

1444. At deposition, when asked the same question, Dr. McCarthy testified to the contrary, 

stating: “mainly compostable–compost bags.” (McCarthy, Tr. 537; RX 841 

(McCarthy, Dep. at 63–64)). 

1445. According to Dr. McCarthy, compostable bags are in competition with compostable 

biodegradable bags. (McCarthy, Tr. 538). 

1446. According to Dr. McCarthy, NatureWorks’ product, produced under patent number 

5,883,199, is in competition with other compostable and biodegradable products in 

the market. (McCarthy, Tr. 538–39; RX 841 (McCarthy Dep. at 65–66)). 

1447. According to Dr. McCarthy, NatureWorks’ product exists in a competitive 

marketplace. (McCarthy, Tr. 539–40; RX 841 (McCarthy Dep. at 65–66). 

1448. Dr. McCarthy admitted that the patent he invented is used by Metabolix which 

competes with ECM for business in the biodegradable plastic bag market. (McCarthy, 

Tr. 537-540). 

1449. In patent number 5,883,199, the test Dr. McCarthy used to demonstrate 

biodegradation of the polymer blends he invented was not an ASTM standard. 

(McCarthy, Tr. 540–41; RX 928). 
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1450. In Dr. McCarthy’s expert report, he states that biodegradation may only be shown 

based on satisfaction of either an ASTM standard specification test or a positive 14C 

radiolabeling test. (CCX 891 (McCarthy, Rep. at 23-4)). 

1451. In patent number 5,883,199, the test Dr. McCarthy used to demonstrate 

biodegradation of the polymer blends he invented was a method used at UMass 

Lowell which is not an ASTM method. (McCarthy, Tr. 541; RX 928). 

1452. In Dr. McCarthy’s expert report, he states that the only definitive test of 

biodegradation, other than an ASTM standard specification test, is a 14C radiolabeling 

test. (CCX 891 (McCarthy, Rep. at 24)). 

1453. In patent number 5,883,199, the test Dr. McCarthy used to demonstrate 

biodegradation of the polymer blends he invented did not use any 14C radiolabeling. 

(McCarthy, Tr. 541–43; RX 928; RX 841 (McCarthy, Dep. at 75). 

1454. Patent number 5,883,199 does not contain a requirement that polymer blends 

biodegrade 100%. (McCarthy, Tr. 543; RX 928). 

1455. In Dr. McCarthy’s expert report, he states that a claim of biodegradation for a plastic 

may only be made if the plastic biodegrades 100% within one year: “the entire treated 

plastic will completely break down and return to nature (i.e., decompose into 

elements found in nature) within one year after customary disposal (i.e., incinerator, 

landfill, or recycling).” (CCX 891 (McCarthy, Rep. at 5)). 

1456. However, at hearing, when asked “nowhere in the patent do you establish that any of 

the five plastic resins you invented completely break down and return to nature, that 

is, decompose into elements found in nature within one year after customary 

disposal?” Dr. McCarthy states “yeah, that’s correct.” (McCarthy, Tr. 544; RX 928). 

1457. In Dr. McCarthy’s expert report, he defines biodegradation in footnote 1 of the report 

as “the entire treated plastic will completely break down and return to nature (i.e., 

decompose into elements found in nature) within one year after customary disposal 

(i.e., incinerator, landfill, or recycling).” (CCX 891 (McCarthy, Rep. at 5)). 

1458. Dr. McCarthy did not test the polymer blends in patent number 5,883,199 to establish 

that they would biodegrade completely within one year after customary disposal. 

(McCarthy, Tr. 545–46; RX 841 (McCarthy, Dep. at 76–77)). 

1459. Patent number 5,883,199 is not limited to the five polymer blends tested in patent 

number 5,883,199. (McCarthy, Tr. 547; RX 928). 

1460. In Dr. McCarthy’s expert report, he states that it is scientifically invalid to extrapolate 

from plastics that are the subject of ASTM tests to those that were not subject to the 

tests: “Such extrapolation is scientifically invalid because biodegradation is not linear 

and typically slows down due to recalcitrance.” (CCX 891 (McCarthy, Rep. at 27)). 
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119 

1461. However, Dr. McCarthy extrapolated from the five blends tested in patent number 

5,883,199 to classify additional blends not tested as biodegradable. (McCarthy, Tr. 

549–50; RX 928). 

1462. In Dr. McCarthy’s expert report, he states that a plastic may not be deemed 

“biodegradable” unless it biodegrades by 100%. (CCX 891 (McCarthy, Rep. at 5)). 

1463. However, at trial, when asked whether the “‘polylactic acid degraded by only 14 

percent by loss in weight;’ right?” Dr. McCarthy replied “that would be after 45 days 

in soil. Yeah.” (McCarthy, Tr. 547–48; RX 928). 

1464. Although patent number 5,883,199 tested only five blends, the patent applies to many 

more blends. (McCarthy, Tr. 548; RX 928). 

1465. Dr. McCarthy reviewed each specification in patent number 5,883,199 and signed a 

declaration affirming the validity of each specification before submitting patent 

number 5,883,199 to the United States Patent and Trademark Office. (McCarthy, Tr. 

548). 

1466. Dr. McCarthy extrapolated from the five blends tested in patent number 5,883,199 to 

classify additional blends not tested as biodegradable. (McCarthy, Tr. 549–50; RX 

928). 

1467. In patent number 5,883,199 Dr. McCarthy ran test method UML-7645 for 45 days to 

determine the biodegradability of polymer blends. (McCarthy, Tr. 554; RX 928). 

1468. In patent number 5,883,199 Dr. McCarthy claims that PET mixed with PLA is 

biodegradable. (McCarthy, Tr. 555; RX 928). 

1469. According to Dr. McCarthy, PET is not biodegradable. (McCarthy, Tr. 557). 

1470. In his expert report, Dr. McCarthy wrote that a study to determine whether something 

is biodegradable “must last long enough for the sample to reach at least 60 percent 

biodegradation.” (McCarthy, Tr. 558; CCX 891 (McCarthy, Rep. at 15)). 

1471. However, the studies Dr. McCarthy conducted in patent number 5,883,199 did not 

last long enough for blends to reach at least 60 percent biodegradation, even though 

Dr. McCarthy identified those blends as biodegradable. (RX 928). 

1472. In his expert report, Dr. McCarthy wrote that a study to determine whether something 

is biodegradable must have a negative control. (McCarthy, Tr. 559; CCX 891 

(McCarthy, Rep. at 16)). 

1473. At hearing, Dr. McCarthy testified, in response to the question of whether he specifies 

a negative control anywhere in patent number 5,888,139, that “[a]gain that wasn’t to 

prove that it’s biodegradable.” (McCarthy, Tr. 559). 
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1474. However, at deposition, in response to the same question, Dr. McCarthy testified to 

the contrary, stating: “I don’t believe there’s a negative control mentioned in the 

patent.” (McCarthy, Tr. 560; RX 928; RX 841 (McCarthy, Dep. at 85)). 

1475. In his expert report, Dr. McCarthy argues that extrapolation from a short test to the 

conclusion that a polymer is biodegradable in the environment is improper. 

(McCarthy, Tr. 560–61; CCX 891 (McCarthy, Rep. at 22)). 

1476. However, the only test Dr. McCarthy reported in patent number 5,883,199 is a 45 day 

test used to determine that certain polymer blends are biodegradable. (McCarthy, Tr. 

561; RX 928). 

1477. Dr. McCarthy’s position, at least as outlined in his expert report, is that “absent an 

approved ASTM specification, it is [his] opinion that to scientifically prove a claim 

that the plastic—not merely the additive and inoculum—is biodegrading, the claimant 

must support its claim with at least one test with positive results from 14C labeling of 

the conventional plastic.” (McCarthy, Tr. 562; CCX 891 (McCarthy, Rep. at 24)). 

1478. However, Dr. McCarthy does not reference any 14C radio labeling testing in patent 

number 5,888,139. (McCarthy, Tr. 562–63; RX 928). 

1479. Dr. McCarthy has never performed any 14C radio labeling testing in any 

biodegradation experiments he has performed at UMass Lowell. (McCarthy, Tr. 

563). 

1480. Dr. McCarthy has not informed the United State Patent and Trademark Office of the 

definition of “biodegradation” or “biodegradable” that is in footnote 1 of his expert 

report that he identifies as interchangeable with the scientific definition. (McCarthy, 

Tr. 563–64). 

1481. Dr. McCarthy criticizes ECM testing materials for allegedly conflating the concepts 

of disintegration or degradation with biodegradation. (McCarthy, Tr. 566–68). 

1482. However, when asked “is it possible for the two processes, that is, degradation and 

biodegradation, to be inextricably intertwined?” Dr. McCarthy said, “I mean, they’re 

separate processes. You mean if they occur at similar times or...” (McCarthy, Tr. 

567). 

1483. McCarthy then admitted that he “know[s] of some instances like the biodegradation 

of polylactic acid” where the processes of degradation and biodegradation are 

inextricably intertwined. (McCarthy, Tr. 568). 

1484. Dr. McCarthy states that it is possible that a first stage process of biodegradation 

would be depolymerization of the macromolecules into shorter chains that are then 

made biodegradable. (McCarthy, Tr. 568). 
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1485. Furthermore, according to Dr. McCarthy extracellular enzymes and/or coenzymes 

and abiotic reactions are responsible for polymeric chain cleavage. (McCarthy, Tr. 

569). 

1486. Dr. McCarthy did not provide any specific citations in support of his opinions in 

paragraphs 25 and 27 of his expert report. (McCarthy, Tr. 569–70; RX 841 

(McCarthy, Dep. at 106); CCX 891 (McCarthy, Rep. at 9)). 

1487. Dr. McCarthy cites to no source at all for the proposition stated in his expert report 

that there is “overwhelming scientific consensus that conventional plastics are not 

biodegradable after customary disposal.” (CCX 891 (McCarthy, Rep. at 13)). 

1488. At deposition, Dr. McCarthy referred to RX 924 as peer reviewed support for the 

proposition that there is “overwhelming scientific consensus that conventional 

plastics are not biodegradable after customary disposal.” (McCarthy, Tr. 570; RX 

841 (McCarthy, Dep. at 112–13)). 

1489. At hearing, however, when asked whether RX 924 was peer reviewed, Dr. McCarthy 

testified to the contrary, stating: “Right. It wasn’t officially peer-reviewed.” 

(McCarthy, Tr. 571–73). 

1490. At hearing, when asked “you are familiar with peer-reviewed scientific publications 

that conclude that indeed conventional plastics are biodegradable, right?” Dr. 

McCarthy testified: “I’m not sure.” (McCarthy, Tr. 573–74). 

1491. However, at deposition, when asked the same question, Dr. McCarthy testified to the 

contrary, stating: “[t]here are publications concerning polyethylene ... [and] there are 

some on polypropylene ... [and] one on PET.” (McCarthy, Tr. 574–75; RX 841 

(McCarthy, Dep. at 115)). 

1492. Despite being aware of peer-reviewed publications that conclude that conventional 

plastics can biodegrade, Dr. McCarthy failed to provide any qualification in his expert 

report regarding his statement that there is “overwhelming scientific consensus that 

conventional plastics are not biodegradable after customary disposal.” (McCarthy, 

Tr. 575–76; CCX 891 (McCarthy, Rep. at 13)). 

1493. Dr. McCarthy admits that that there is a particular strain of fungi that biodegrades 

petroleum-based plastic. (McCarthy, Tr. 577; CCX 891 (McCarthy, Rep. at 29 n. 

20)). 

1494. In footnote 20 to his expert report, Dr. McCarthy stated without citation to a source 

that there was no evidence that a fungi that biodegrades petroleum-based plastic 

existed in the United States. (CCX 891 (McCarthy, Rep. at 29)). 

1495. At hearing, however, Dr. McCarthy admitted that he knows of no peer-reviewed 

article concluding that the strain of fungi that biodegrades petroleum-based plastic 

does not exist in the United States. (McCarthy, Tr. 577). 
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1496. Dr. McCarthy authored an article entitled “Advances in Properties and 

Biodegradability of Co-Continuous, Immiscible, Biodegradable, Polymer Blends.” 

(McCarthy, Tr. 577–78; RX 940). 

1497. In “Advances in Properties and Biodegradability of Co-Continuous, Immiscible, 

Biodegradable, Polymer Blends, Dr. McCarthy measured the biodegradability with 

the Proteinase K,” Dr. McCarthy explains testing on the soil and the composting for 

the blends which are the basis for patent number 5,883,199. (McCarthy, Tr. 578; RX 

940). 

1498. In measuring biodegradability of polymer blends in “Advances in Properties and 

Biodegradability of Co-Continuous, Immiscible, Biodegradable, Polymer Blends,” 

Dr. McCarthy did not use 14C radiolabeling testing. (McCarthy, Tr. 578–79; RX 

940). 

1499. In measuring biodegradability of polymer blends in “Advances in Properties and 

Biodegradability of Co-Continuous, Immiscible, Biodegradable, Polymer Blends,” 

Dr. McCarthy did not rely on an ASTM standard testing method. (McCarthy, Tr. 

579; RX 940). 

1500. In measuring biodegradability of polymer blends in “Advances in Properties and 

Biodegradability of Co-Continuous, Immiscible, Biodegradable, Polymer Blends,” 

Dr. McCarthy used his university’s own testing method. (McCarthy, Tr. 579; RX 

940). 

1501. In “Advances in Properties and Biodegradability of Co-Continuous, Immiscible, 

Biodegradable, Polymer Blends,” Dr. McCarthy concluded that certain test samples 

were biodegradable without proving that the samples completely biodegraded within 

one year after customary disposal. (McCarthy, Tr. 582; RX 940). 

1502. Dr. McCarthy authored an article entitled “Biodegradable Polymer Blends of 

Poly(lactic acid) and Poly(ethylene glycol).” (McCarthy, Tr. 583; RX 941). 

1503. In “Biodegradable Polymer Blends of Poly(lactic acid) and Poly(ethylene glycol),” 

Dr. McCarthy measured enzymatic degradation based solely on a weight loss 

calculation. (McCarthy, Tr. 583–84). 

1504. In “Biodegradable Polymer Blends of Poly(lactic acid) and Poly(ethylene glycol),” 

Dr. McCarthy measured enzymatic biodegradation without using an ASTM standard. 

(McCarthy, Tr. 584). 

1505. In “Biodegradable Polymer Blends of Poly(lactic acid) and Poly(ethylene glycol),” 

Dr. McCarthy measured enzymatic biodegradation without using any 14C 

radiolabeling testing. (McCarthy, Tr. 584). 

1506. Dr. McCarthy co-authored an article entitled “Degradation Ranking of Plastics in a 

Landfill Environment.” (McCarthy, Tr. 585; RX 942). 
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1507. In “Degradation Ranking of Plastics in a Landfill Environment,” Dr. McCarthy did 

not use 14C radiolabeling testing. (McCarthy, Tr. 858; RX 942). 

1508. In “Degradation Ranking of Plastics in a Landfill Environment,” Dr. McCarthy used 

weight loss to measure degradability. (McCarthy, Tr. 858; RX 942). 

1509. In “Degradation Ranking of Plastics in a Landfill Environment,” Dr. McCarthy did 

not use any ASTM method to determine degradability. (McCarthy, Tr. 858; RX 942). 

1510. In “Degradation Ranking of Plastics in a Landfill Environment,” Dr. McCarthy 

evaluated the appearance of samples to determine if they looked weathered. 

(McCarthy, Tr. 858; RX 942). 

1511. Dr. McCarthy authored an article entitled “Biodegradable Blends of Bacterial 

Polyesters with Polyethylene and Polystyrene.” (McCarthy, Tr. 586; RX 945). 

1512. No author of “Biodegradable Blends of Bacterial Polyesters with Polyethylene and 

Polystyrene” established that the polyethylene and polystyrene blends tested 

completely break down and return to nature within one year after customary disposal. 

(McCarthy, Tr. 586; RX 945). 

1513. Dr. McCarthy co-authored an article entitled “The Effect of Hyperbranched Polymers 

on Processing and Thermal Stability of Biodegradable Polyesters.” (McCarthy, Tr. 

587; RX 946). 

1514. In “The Effect of Hyperbranched Polymers on Processing and Thermal Stability of 

Biodegradable Polyesters,” Dr. McCarthy characterized polyhydroxybutyrate as 

wholly biodegradable. (McCarthy, Tr. 587; RX 946). 

1515. At hearing, when asked if the authors of “The Effect of Hyperbranched Polymers on 

Processing and Thermal Stability of Biodegradable Polyesters” established that 

polyhydroxybutyrate completely decomposed into elements found in nature within 

one year after customary disposal, Dr. McCarthy testified: “I believe that was 

demonstrated.” (McCarthy, Tr. 587). 

1516. However, at deposition, when asked the same question, Dr. McCarthy testified to the 

contrary, stating: “No.” (McCarthy, Tr. 589; RX 841 (McCarthy, Dep. at 180)). 

1517. Dr. McCarthy co-authored an article entitled “Microwave-Assisted Solvent-Free or 

Aqueous-Based Synthesis of Biodegradable Polymers.” (McCarthy, Tr. 591–92; RX 

948). 

1518. At hearing, when asked “does the article [“Microwave-Assisted Solvent-Free or 

Aqueous-Based Synthesis of Biodegradable Polymers”] establish that the polymers 

would biodegrade such that they would break down and return to nature, 

decomposing into elements found in nature within one year after customary 

disposal?” Dr. McCarthy testified: “Yes.” (McCarthy, Tr. 590). 
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1519. However, at deposition, when asked the same question, Dr. McCarthy testified to the 

contrary, stating: “No.” (McCarthy Tr. 592; RX 841 (McCarthy, Dep. at 185)). 

1520. At hearing, when asked “does all paper completely break down and return to nature, 

that is, decompose into elements found in nature within one year of customary 

disposal?” Dr. McCarthy testified: “Yeah. I think so.” (McCarthy, Tr. 592–93). 

1521. However, at deposition, when asked the same question, Dr. McCarthy testified to the 

contrary, stating: “No.” (McCarthy, Tr. 593; RX 841 (McCarthy, Dep. at 185)). 

1522. According to Dr. McCarthy, a tree trunk is biodegradable if it does not completely 

return to elements found in nature within one year after customary disposal. 

(McCarthy, Tr. 594). 

1523. According to Dr. McCarthy, an orange peel is biodegradable if it does not return to 

elements in nature within one year after customary disposal. (McCarthy, Tr. 594). 

1524. Dr. McCarthy cannot name each species of microbial life that dwell in a landfill. 

(McCarthy, Tr. 594). 

1525. Dr. McCarthy cannot explain the life cycle of all species of microbial life that dwell 

in a landfill. (McCarthy, Tr. 594). 

1526. Dr. McCarthy cannot identify all the stimuli that cause microbial life forms to 

produce enzymes. (McCarthy, Tr. 594). 

1527. There is a Fee-for-Service Agreement between UMass Lowell and Metabolix. 

(McCarthy, Tr. 595; RX 961). 

1528. The Fee-for-Service Agreement between UMass Lowell and Metabolix lists Dr. 

McCarthy as the principal investigator. (McCarthy Tr. 595–96; RX 961). 

1529. According to Dr. McCarthy, it is not necessary from a scientific perspective that 

“biodegradation” means only that substances break down into single elements. 

(McCarthy, Tr. 597). 

1530. According to Dr. McCarthy, PET is a homopolymer. (McCarthy, Tr. 597–98). 

1531. Patent number 5,883,199 allows a blend of a homopolymer to be biodegradable. 

(McCarthy, Tr. 598; RX 928). 

1532. Dr. McCarthy tailored his opinion in this matter to meet Complaint Counsel’s needs, 

even accepting the fundamental definition of what “biodegradation” means from 

Complaint Counsel, despite contrary representations in his own scientific articles and 

in his own patent. (McCarthy, Tr. 485–87, 488, 494). 
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1533. Dr. McCarthy testified that he prepared his expert report as a “collaborative effort 

between [himself] and complaint counsel.” (McCarthy, Tr. 487; RX 841 (McCarthy, 

Dep. at 20)). 

1534. Email correspondence from Complaint Counsel to ECM in July 2013 mirrored the 

content in Dr. McCarthy’s expert report. (RX 593; CCX 891 (McCarthy, Expert 

Report)). 

1535. Dr. McCarthy’s expert report stated that radiological marker 14C testing is the only 

test that can dispositively prove that ECM’s additive causes biodegradation of 

plastics, but he himself has relied on extrapolation and other tests (that neither adhere 

to an ASTM standard nor involve radiological markers), such as one he used at 

UMass., UML-7645, and measures of weight loss, to prove biodegradability of 

polymer products. (McCarthy, Tr. 540–42; RX 841 (McCarthy, Dep. 74–75, 148–

149, 165–172)). 

1536. In other materials, Dr. McCarthy was silent on the need for a product to biodegrade 

within a year to be biodegradable, and yet, for ECM’s additive, Dr. McCarthy is 

adhering to the one year rule contained in FTC’s Revised Green Guides in 

collaboration with Complaint Counsel. (McCarthy, Tr. 544–45; RX 841 (McCarthy, 

Dep. at 19–42)). 

1537. Dr. McCarthy did not adhere to the “One-Year Rule” in his ‘199 patent when 

defining biodegradable. (McCarthy, Tr. 544–45; RX 841 (McCarthy, Dep. at 69–76); 

RX 928). 

1538. Dr. McCarthy selectively applies the “One-Year Rule,” opining that a banana peel, 

tree trunk, and orange peel are biodegradable despite the fact that they may not fully 

biodegrade within a year. (McCarthy, Tr. 503–04, 506, 508; RX 841 (McCarthy, Dep. 

at 185–87)). 

1539. Dr. McCarthy’s report states that “evidence that a substance is biodegradable is not 

‘competent and reliable’ unless the tested sample reaches ‘at least 60% 

biodegradation,’ and there is both a ‘negative control’ and a ‘positive control.’” 

(McCarthy, Tr. 558–59; RX 891 (McCarthy, Rep. at 15)). 

1540. Dr. McCarthy asserts that extrapolation is prohibited under the current ASTM 

standards, thus 100% biodegradation in the laboratory would be required. (McCarthy, 

Tr. 477–78). 

1541. Dr. McCarthy further asserts that he is unaware of any circumstances where 

extrapolation would be appropriate when assessing the biodegradability of a product. 

(McCarthy, Tr. 478). 

1542. However, McCarthy’s ‘199 patent made biodegradable claims even though the rate of 

biodegradation was lower than 60%, reaching only 14% in 45 days, and where he did 

not use a negative control. (McCarthy, Tr. 558–560; RX 928). 
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1543. Dr. McCarthy’s prior research on biodegradable plastics did not meet the same 60% 

threshold that he now requires of ECM’s additive. (RX 928). There is no consensus in 

the peer-reviewed literature, or any requirement whatsoever, that a gas evolution 

should produce 60 percent biodegradation before a test article can be deemed 

biodegradable. (Sahu, Tr. 1793). 

1544. Complaint Counsel’s experts have provided no literature or documentary evidence 

showing that scientists in the field require 60 percent or greater biodegradation before 

a product can be deemed biodegradable. (McCarthy, Tr. 359-680). 

1545. Complaint Counsel’s rebuttal expert, Dr. Michel, unambiguously testified that a 

“material that only biodegrades 44 percent to elements found in nature is 

biodegradable.” (Michel, Tr. 2961). 

1546. The fact that a plateau formed in testing conditions before the biodegradation reached 

sixty percent did not prevent Dr. Michel from declaring the product still 

biodegradable. (Michel, Tr. 2961).Although Dr. McCarthy’s test data showed much 

less than 60% biodegradation, he extrapolated his gas evolution test data, and used it 

to say that the test material was fully biodegradable. (Sahu, Tr. 1894; RX 756 at 8-

12). 

1547. Dr. McCarthy has labeled a substrate “biodegradable” after observing just fourteen 

(14%) percent biodegradation in 45 days. (Sahu, Tr. 1894; RX 756 at 11). 

1548. Dr. McCarthy has said that polylactic acid (PLA) is “biodegradable.” According to 

Dr. McCarthy, “polylactic acid is a biodegradable polymer...” (RX 756 at 2; 

McCarthy, Tr. 376). 

1549. Although Dr. McCarthy has repeatedly acknowledged that PLA is biodegradable (RX 

756 at 2; McCarthy, Tr. 376), his testing revealed that PLA biodegraded only 14% 

after 45 days of biodegradation testing. (RX 756 at 11 (example 3)). 

1550. In another of Dr. McCarthy’s own composting tests, PLA degraded only 3% in 20 

days. (RX 756 at 11 (example 4)). 

1551. Dr. McCarthy takes the position that for any given polymer that the amorphous 

regions will biodegrade faster than the crystalline regions. (McCarthy, Tr. 613). 

1552. Dr. McCarthy does not know whether it is possible for an amorphous polymer with 

extremely high molecular weight and relatively low surface area to biodegrade slower 

than a crystalline polymer of relatively low molecular weight and with a relatively 

high surface area. (McCarthy, Tr. 616–17). 

1553. Dr. McCarthy’s expert report makes no explicit reference to amorphous and 

crystalline regions of a polymer. (McCarthy, Tr. 625–26). 

1554. Dr. McCarthy makes no statement whatsoever as to what percentage of a polymer is 

comprised of amorphous regions and what percentage of a polymer is comprised of 

crystalline regions. (McCarthy, Tr. 358–689; CCX 891 (McCarthy, Rep.); CCX 892 

(McCarthy, Rebuttal Rep.)). 
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1555. Polyethylene, polypropylene, polyvinyl chloride, and polystyrene are all 

thermoplastics (RX 855 at 31), which have an “overall structure that is generally 

amorphous” (RX 855, at 15 (quoting Lampman, S., Characterization and Failure 

Analysis of Plastics, ASM International, 2003, p.7)). 

1556. Dr. McCarthy believes that “one of the most serious flaws in the conclusion of 

[ECM’s] experts is that once biodegradation is established, it will continue to 

completion.” (McCarthy, Tr. 629; CCX 892 (McCarthy, Rebuttal Rep. at 9)). 

1557. However, in patent number 5,883,199, Dr. McCarthy concluded that a substance that 

biodegraded by 25% in 45 days was biodegradable. (McCarthy, Tr. 630–34; RX 

928). 

1558. Dr. McCarthy co-authored an article entitled “The Influence of Injection Molding 

Conditions on Biodegradable Polymers.” (McCarthy, Tr. 634; RX 969). 

1559. In “The Influence of Injection Molding Conditions on Biodegradable Polymers,” Dr. 

McCarthy analyzed certain polymers for their rates of biodegradation. (McCarthy, 

Tr. 635–36; RX 969). 

1560. Dr. McCarthy believes that a biodegradation study must last long enough for the same 

to reach at least 60 percent biodegradation. (McCarthy, Tr. 637; RX 891 (McCarthy, 

Rep. at 15)). 

1561. Dr. McCarthy agrees that ordinarily 60 percent biodegradation of a sample is not 

something that can occur in just a few minutes. (McCarthy, Tr. 637–38). 

1562. In “The Influence of Injection Molding Conditions on Biodegradable Polymers,” Dr. 

McCarthy measured rates of degradation by conducting a test that lasted five minutes. 

(McCarthy, Tr. 638; RX 969). 

1563. Dr. McCarthy relied on the tests he reported in “The Influence of Injection Molding 

Conditions on Biodegradable Polymers” to draw conclusions about the 

biodegradability of polymers. (McCarthy, Tr. 638–39; RX 969). 

1564. The testing reported in “The Influence of Injection Molding Conditions on 

Biodegradable Polymers” fails to demonstrate 60 percent biodegradation. 

(McCarthy, Tr. 639; RX 969). 

1565. Dr. McCarthy believes the photodegradation is not a form of biodegradation because 

photodegradation is abiotic. (McCarthy, Tr. 646–47). 

1566. However, in “A Review on Recent Trends and Emerging Perspectives,” published in 

the Journal of Polymers and the Environment that Dr. McCarthy edits, the authors 

include abiotic degradation within a diagrammatic representation of the chemistry of 

biodegradation. (McCarthy, Tr. 647; RX 925). 
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1567. Dr. McCarthy failed, in patent number 5,883,199, to provide any data demonstrating 

that the addition of an aliphatic chain segment to PET would make the PET 

biodegradable. (McCarthy, Tr. 653–54; RX 928). 

1568. Dr. McCarthy did not run any statistics for any D5511 studies on ECM plastic. 

(McCarthy, Tr. at 654). 

1569. At hearing, Dr. McCarthy testified that if a polymer loses a chlorine ion, the 

polymer’s overall molecular weight “will decrease... by like 1 percent.” (McCarthy, 

Tr. 661). 

1570. Then, when asked at hearing “so the molecular weight of a repeat unit of PVC is 62?” 

Dr. McCarthy testified: “Yeah.”. (McCarthy, Tr. 663). 

1571. When asked “and what is the molecular weight of a repeat unit of PVC after a loss of 

chlorine, Dr. McCarthy testified: “27.” (McCarthy, Tr. 663). 

1572. The difference between 62 and 27 is not one percent. (McCarthy, Tr. 664). 

1573. Since 2003, Dr. McCarthy has not conducted any surveys of scientists, 

manufacturers, or consumers concerning their understanding of the meaning of 

“biodegradation.” (McCarthy, Tr. 666). 

1574. Dr. McCarthy testified that the only way to make PE biodegradable is by adding a 

pro-oxidant to the PE or by having the PE achieve a molecular weight of 500. 

(McCarthy, Tr. 666). 

1575. However, in “A Review on Recent Trends and Emerging Perspectives,” published in 

the Journal of Polymers and the Environment that Dr. McCarthy edits, the authors 

state that the insertion of weak links into polymers can cause biodegradation. 

(McCarthy, Tr. 670–71; RX 925). 

1576. Furthermore, in “A Review on Recent Trends and Emerging Perspectives,” published 

in the Journal of Polymers and the Environment that Dr. McCarthy edits, the authors 

state that compounding polymers with photosensitizers can cause biodegradation. 

(McCarthy, Tr. 672; RX 925). 

1577. In “A Review on Recent Trends and Emerging Perspectives,” published in the 

Journal of Polymers and the Environment that Dr. McCarthy edits, the authors state 

“the most frequently adopted approach to degradability design of [Low Density 

Polyethylene] LDPE has been to introduce pro-degradant additives such as starch and 

cellulose into synthetic polymers.” (McCarthy, Tr. 673–74; RX 925). 

1578. Dr. McCarthy failed to inform the authors of “A Review on Recent Trends and 

Emerging Perspectives” that they had no basis for the claim that one can blend a 

biodegradable additive into an otherwise nonbiodegradable polymer and cause the 

nonbiodegradable polymer to become biodegradable. (McCarthy, Tr. 674), 
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1579. Dr. McCarthy has never performed any tests on ECM amended plastic. (McCarthy, 

Tr. 678). 

1580. Dr. McCarthy did not provide any specific scientific citation to support his statement 

that all of the ECM additive buried in crystalline phases would become instantly 

inaccessible for biodegradation. (McCarthy, Tr. 678). 

XI. COMPLAINT COUNSEL HAS NOT SHOWN THAT ECM’S 

BIODEGRADABILITY CLAIM IS FALSE 

A. Complaint Counsel Provided No Evidence Concerning What 

Competent and Reliable Scientific Evidence Can Show the Rate 

that a Product will Biodegrade in a Landfill 

1581. Complaint Counsel provided no testimony or evidence concerning what competent 

and reliable scientific evidence would be required to prove the rate that a product will 

biodegrade in an MSW landfill. (Tolaymat, Tr. 218-220; McCarthy, Tr. 359-480). 

1582. There is no record evidence showing which tests, if any, are competent and reliable to 

establish the rate of biodegradation in the highly variable landfill environment. 

(Tolaymat, Tr. 112-212, 213-358; McCarthy, Tr. 359-480, 523-680). 

1583. When questioned repeatedly concerning which tests, if any, can be used by a 

company to prove the rate of biodegradation in an MSW landfill, Dr. Tolaymat had 

not test to recommend. (Tolaymat, Tr. 219-21; 222-24). 

1584. Dr. Tolaymat has never seen any company use an in-situ study to determine 

biodegradability. (Tolaymat, Tr. 224). 

1585. Dr. Tolaymat never encountered any in-situ landfill experiment that tested a specific 

product for biodegradability, as opposed to waste generally. (Tolaymat, Tr. 224). 

1586. Dr. Tolaymat testified that no one test could support a rate of biodegradation in 

landfills, and that the rate of biodegradation is a matter of scientific judgment. 

(Tolaymat, Tr. 261-62). 

1587. Dr. McCarthy testified at length concerning types of scientific studies that might be 

used to assess biodegradability of polymers generally. (McCarthy, Tr. 359-480). 

1588. Dr. McCarthy did not, however, provide any testimony concerning the specific type 

of testing required to demonstrate the rate of biodegradation in an MSW landfill. 

(McCarthy, Tr. 359-480). 
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1589. Dr. Barlaz testified that there is no uniformly used method to extrapolate rate data 

from laboratory scale testing to field-scale landfills. (Barlaz, Tr. 2282). 

1590. Dr. Barlaz explained that “it’s very, very difficult to measure rates at either – at field 

scale either for individual components or for bulk waste, so all we have is the lab.” 

(Barlaz, Tr. 2282). 

1591. Dr. Barlaz explained that he would never use a BMP test to establish rate data. 

(Barlaz, Tr. 2231). 

1592. Dr. Barlaz has published a proposed theory that suggests an extrapolation method 

from the lab to the landfill, but that method has not been generally accepted and is not 

generally used. (Barlaz, Tr. 2281-82). 

1593. With respect to the rate of biodegradation, Dr. Barlaz wrote in his report that because 

the residence of waste in a landfill is essentially infinite, if a material is 

biodegradable, then it is not clear that it matters whether it biodegrades with a decay 

rate of 0.02 or 0.2. (RX 853 at 12). 

1594. Dr. Barlaz testified that if a material is disposed in a landfill, then for the purpose of 

whether it biodegrades, it does not matter whether it degrades in two, ten, or twenty 

years. (Barlaz, Tr. 2283-84). 

1595. Dr. Barlaz testified that a material which degrades slowly in a landfill is more 

environmentally beneficial than a product that biodegrades rapidly. (Barlaz, Tr. 

2284-85). 

1596. Methane is a greenhouse gas that contributes to climate change. (Barlaz, Tr. 2285). 

1597. As methane gas increases in the atmosphere, it contributes to warming of the 

atmosphere, which the preponderance of scientists would suggest is damaging to the 

planet. (Barlaz, Tr. 2286). 

1598. EPA regulations do not require landfill owners to install gas collection systems until 

five years after waste burial. (Barlaz, Tr. 2285). 

1599. In a typical case, a landfill owner begins collecting gas in about two years after waste 

burial. (Barlaz, Tr. 2285). 

1600. If a product biodegrades rapidly within two years (or five years), it will not take up 

space in a landfill, but the methane produced will not be captured and that will have 

less desirous environmental consequences than the simple storage of a product in a 

landfill for a longer period of time. (Barlaz, Tr. 2285-86). 
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1601. Dr. Barlaz has mapped (RX 853 at 26 (figure 8)) the global warming potential, which 

measures a system’s contribution to greenhouse gases. (Barlaz, Tr. 2286-87). 

1602. Dr. Barlaz testified, and wrote in peer reviewed publications, that based on decay rate 

the slower a product biodegrades in a landfill environment, the better that product is 

for the environment after disposal. (Barlaz, Tr. 2287-88). 

1603. Stated differently, Dr. Barlaz explained that: 

The reason we make products is for people to use them, not to 

throw them in a landfill... What we’re trying to do here is ask, 

given the fact that waste exists and waste is generated, what’s the 

best thing to do with it and what’s the best way to design a 

product, without impending its functionality, to minimize 

environmental impact.” 

(Barlaz, Tr. 2288). 

1604. A plastic product that completely biodegrades in a landfill within one year after 

customary disposal would be a net contributor to global methane emissions at a 

typical landfill. (Barlaz, Tr. 2289-90). 

1605. For the typical landfill that does not collect gas for years after disposal, a product that 

biodegraded completely within one year after disposal would be a net emitter of 

methane to the environment and therefore have negative environmental impact over a 

more slowly degrading substance. (Barlaz, Tr. 2289-90). 

B. Experts Agree that Gas Evolution Tests Are Competent and 

Reliable Evidence to Prove that a Product is “Biodegradable” 

1606. Numerous gas evolution tests have shown that plastics manufactured with ECM’s 

additive, which otherwise do not biodegrade, have biodegraded to a degree that is 

substantially more than biodegradation that could have been sourced solely by the 

ECM additive. (Barlaz, Tr. 2175; Sahu, Tr. 1934-37; RX 248; RX 254; RX 263; RX 

265; RX 266; RX 268; RX 273; RX 276; RX 392; RX 393; RX 394; RX 395; RX 

396; RX 398; RX 399; RX 401; RX 403; RX 402; RX 405; RX 465; RX 467; RX 

468; RX 836; RX 838; RX 839; CCX 534; CCX 546; CCX 547; CCX 548; CCX 

952). 

1607. Other studies, including qualitative tests and data, support the conclusions drawn 

from gas evolution testing, to wit, that plastics manufactured with the ECM additive 

render the otherwise non-biodegradable plastic biodegradable. (RX 254; RX 269; RX 

271; RX 274; RX 275; RX 278; RX 277; RX 388-91). 
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1608. Industry has relied on several test models to prove biodegradability, but all experts in 

this case agree that “gas evolution” data is competent and reliable evidence to prove 

biodegradability, and it is the most practical and widely used measure of 

biodegradation (both aerobic and anaerobic) in the scientific field. (RX 853 at 7-8). 

1609. Dr. Tolaymat testified that gas evolution tests are reliable evidence to show 

biodegradation in landfills. (Tolaymat, Tr. 171). 

1610. Dr. McCarthy testified that gas evolution or “respirometric” testing is used by 

scientists to assess biodegradability. (McCarthy, Tr. 413-14). 

1611. In fact, Dr. McCarthy himself relied on gas evolution data when assessing whether 

plastic polymers that he designed were biodegradable under anaerobic conditions. 

(McCarthy, Tr. 547-48; RX 756 at column 11). 

1612. Dr. McCarthy has never himself conducted carbon-14 radiolabeled testing on plastic 

polymers to demonstrate biodegradability. (McCarthy, Tr. 359-680). 

1613. Dr. Sahu testified that gas evolution testing was generally relied upon by scientists to 

show the biodegradability of materials. (Sahu, Tr. 1792). 

1614. Dr. Barlaz testified that data from gas evolution testing was competent and reliable 

evidence of biodegradability, and that scientists in the field generally rely on same. 

(Barlaz, Tr. 2245-46). 

1615. Dr. Burnette testified that gas evolution tests, like the D5511 test, are useful for 

predicting some baseline performance in landfill settings, albeit not optimal. 

(Burnette, Tr. 2435-39). 

1616. When assessing whether plastic materials were anaerobically biodegradable, Dr. 

Michel relied on ASTM D5511 gas evolution testing. (Michel, Tr. 2904-05). 

1617. Dr. Michel has never performed a radiolabeled test to measure biodegradation of 

plastic polymers or products. (Michel, Tr. 2906). 

1618. There are no practical tests that precisely simulate or replicate all landfill conditions, 

and Complaint Counsel has offered no such method through its experts, but tests 

showing that one or more common bacteria in a closed test environment do 

biodegrade plastic are generally accepted as predictive of biodegradation in landfills 

where many multiple kinds of biodegrading bacteria and fungi are present. (RX-756 

at 6–12; RX-853 at 7–9; RX-865 at 41–47). 

1619. Dr. Tolaymat was unable to give an example of a practical laboratory test that would 

simulate landfill conditions, but also be accelerated so that testing would not be 

required to continue for decades. (Tolaymat, Tr. 247-50). 
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1620. Dr. Sahu testified that accelerated testing was reasonably required to produce results 

within a reasonable time frame, and that accelerated testing is commonly done in 

many scientific fields. (Sahu, Tr. 1924). 

1621. Dr. Sahu explained that accelerated biodegradation testing, which may not mimic 

every aspect of the landfill, remains competent and reliable to demonstrate intrinsic 

biodegradability. (Sahu, Tr. 1924-26). 

1622. Dr. Barlaz explained that attempting to truly “simulate” a landfill environment might 

require testing that spans 100 years. (Barlaz, Tr. 2212). 

1623. Dr. Barlaz explained that “it’s not practical to try to simulate that kind of ecosystem 

at the time scale in the laboratory.” (Barlaz, Tr. 2212). 

1624. Dr. Barlaz explained that the biodegradability (or anaerobic biodegradability) nature 

of a product is a characteristic of the material generally. (Barlaz, Tr. 2217-18). 

1625. The biodegradability of a product describes a property of the material, much like its 

color or weight or density. (Barlaz, Tr. 2218). 

1626. That property will not change regardless of where the material is placed. (Barlaz, Tr. 

2218). 

1627. Tests like the ASTM D5511, and well-designed gas evolution tests, are competent 

and reliable to assess the intrinsic biodegradability of a test material. (Barlaz, Tr. 

2219). 

1628. A product that is “biodegradable” will biodegrade at various rates and to various 

extents based on the external environmental conditions, but will remain 

“biodegradable” regardless. (Barlaz, Tr. 2218-19). 

XII. DR. RANAJIT SAHU’S TESTIMONY 

A. Dr. Sahu Testified that Plastic Containing the ECM Additive is 

Biodegradable 

1629. Plastics manufactured using the ECM additive technology are shown to be 

biodegradable under conditions of customary disposal, including landfills. (Sahu, Tr. 

1752). 

1630. Plastics containing the ECM additive are expected to biodegrade at a rate faster than 

corresponding plastics without such additives. (Sahu, Tr. 1753-54). 
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1631. Dr. Sahu testified that a plastic containing the ECM additive would fully biodegrade 

under customary disposal conditions over time. (Sahu, Tr. 1754). 

1632. Dr. Sahu based his opinion on a thorough literature review of peer-reviewed literature 

published since the 1950s, as well as between 30-40 different tests collected during 

this case. (Sahu, Tr. 1754-56). 

1633. He reviewed several hundred peer-reviewed articles. (Sahu, Tr. 1791). 

1634. Dr. Sahu’s report includes many of the citations to, and discussions of, the literature 

that he relied on. (Sahu, Tr. 1791; RX 855). 

1635. Conventional plastics are those made from petroleum feedstocks or natural gas, as 

opposed to those manufactured from biological materials like starches. (Sahu, Tr. 

1758). 

1636. It is commonly accepted that conventional plastics last very long in the environment, 

perhaps tens of thousands of years. (Sahu, Tr. 1758-59; CCX 891 at ¶ 17). 

1637. Polyethylene can be considered a conventional plastic in the sense that it is ordinarily 

derived from feedstocks like petroleum or natural gas. (Sahu, Tr. 1784). 

1638. Conventional plastics have only existed in modern manufacturing for about ninety to 

one hundred years. (Sahu, Tr. 1879). 

1639. Biodegrading a substance into elements found in nature means to reduce the item 

from complex molecules into smaller molecules that may be broken down. (Sahu, Tr. 

1763-64). 

1640. Biodegradation processes are highly variable in the heterogeneous landfill 

environment, where you have different microenvironments throughout the landfill. 

(Sahu, Tr. 1768-69). 

1641. A landfill, by its nature, is different from a controlled laboratory reactor; in the latter 

scientists attempt to control the environment to eliminate variables. (Sahu, Tr. 1769). 

1642. A landfill cannot be standardized or homogenized. (Sahu, Tr. 1769-70). 

1643. That means the level of biodegradation and activity will be variable in the landfill 

environment. (Sahu, Tr. 1769-70). 

1644. The differing pockets of activity and varying conditions in a landfill will have an 

effect on the rate of biodegradation. (Sahu, Tr. 1770-71). 

1645. There are methods to degrade plastics that involve chemical agents, or even 

incineration. (Sahu, Tr. 1771-72). 
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1646. Biodegradation of materials is a different concept than chemical degradation. (Sahu, 

Tr. 1771-72). 

1647. There are many different grades of plastics in the commercial stream. (Sahu, Tr. 

1785). 

1648. For instance, polyethylene has at least ten different commercial grades. (Sahu, Tr. 

1788). 

1649. In general, because the end application of ECM plastics is not demanding (e.g., 

plastics made for carrying groceries vs. medical devices), the grade of polymer used 

in manufacturing ECM plastics is not high. (Sahu, Tr. 1877-78). 

1650. Plastics that are intended for garbage bags or packaging materials can be made of 

lesser grade than plastics intended for more specific uses. (Sahu, Tr. 1878). 

1651. Lesser grade plastics are more likely to contain impurities and inconsistencies that 

promote biodegradation. (Sahu, Tr. 1878-79). 

1652. Polyethylene is comprised of the monomer ethylene, which is a repeating unit in the 

polyethylene polymer. (Sahu, Tr. 1788). 

1653. Although scientists in the field ordinarily rely on gas evolution data to measure 

biodegradation in laboratory environments, they also rely on a range of test batteries 

for supporting data. (Sahu, Tr. 1792-93). 

1654. Tests of all durations can be useful in assessing biodegradability, including shorter 

term testing. (Sahu, Tr. 1795). 

1655. Dr. Sahu evaluated different polymers, including polyethylene, polypropylene, and 

polystyrene. (Sahu, Tr. 1800-01). 

1656. He focused on certain polymers because the vast majority of ECM plastics 

manufactured by customers (about three quarters) are polyethylene-based products. 

(Sahu, Tr. 1801; RX 471). 

1657. Conventional plastics like polyethylene have been proven to be biodegradable in the 

peer reviewed literature. (Sahu, Tr. 1848-53). 

1658. Inclusion of the ECM additive, a biodegradable substance and attractant for 

microbiological growth, contributes to an acceleration of biodegradation. (Sahu, Tr. 

1853-55). 

1659. Dr. Sahu’s opinion is consistent with the peer reviewed literature. (RX 855). 
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1660. Tokiwa, Y., et al. explained in the International Journal of Molecular Sciences (2009) 

that “the adherence of microorganisms on the surface of plastics followed by the 

colonization of the exposed surface is the major mechanisms involved in the 

microbial degradation of plastics.” (RX 582; RX 855 at 28). 

1661. Tokiwa, et al., further explained that many factors, including the polymer 

morphology, chemical and physical properties of the plastics, the surface conditions 

(e.g., surface area, hydrophilic and hydrophobic properties), the molecular weight and 

molecular weight distribution, glass transition temperature, melting temperature, and 

crystallinity are just some of the many factors that can affect the rate of 

biodegradability of plastics. (RX 855 at 28; RX 582). 

1662. Molecular weight is a basic concept in chemistry, and molecular weights are 

generally consistent. (Sahu, Tr. 1804-05). 

1663. For instance, the molecular weight of carbon dioxide is 44, no matter where it exists 

because it contains one carbon and two oxygen atoms. (Sahu, Tr. 1804-05). 

1664. However, polymers are different because they are not specifically defined molecules. 

(Sahu, Tr. 1805). 

1665. A polyethylene product does not have the same number of repeating monomer units 

in each strain. (Sahu, Tr. 1805). 

1666. Because polymer chains have varying lengths within a product, the strains have 

different molecular weights, and that creates a molecular weight distribution. (Sahu, 

Tr. 1805). 

1667. There is no way to manufacture a polymer and ensure that all the lengths of the 

individual chains in the same polyethylene product melt have the same molecular 

weight. (Sahu, Tr. 1807-08). 

1668. Molecular weight distribution will affect product characteristics such as tensile 

strength. (Sahu, Tr. 1808-09). 

1669. The ECM additive affects molecular weight as a system-wide “MasterBatch” additive 

that enters the structure of the plastic. (Sahu, Tr. 1809-10). 

1670. The ECM additive thus alters the plastic matrix, the polymer chains, and adds an 

attractant that permits microorganisms to take root at the surface and within the 

plastic. (Sahu, Tr. 1810-11). 
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B. Dr. Sahu Testified to the Manufacturing Process of Plastic 

Containing the ECM Additive 

1671. The ECM additive is introduced to the plastic as a pellet, which is melted together 

with the plastic resin to form a film or packaging material. (Sahu, Tr. 1813). 

1672. The melted compound is usually extruded or blown and then cooled. (Sahu, Tr. 

1813). 

1673. ECM plastics are also manufactured using injection molding. (Sahu, Tr. 1816-17). 

1674. When the ECM additive is melt-compounded into the final plastic, the goal is to 

disperse the additive evenly throughout the plastic, like a colorant (color additive). 

(Sahu, Tr. 1814-15). 

1675. High temperatures or scorching during the manufacturing process render the ECM 

additive ineffective. (Sahu, Tr. 1815). 

1676. If the additive was overheated or scorched, it may not be apparent or obvious to the 

plastic manufacturer. (Sahu, Tr. 1815). 

1677. Companies may leave the additive “on the screw” while manufacturing, which cooks 

the additive. (Sinclair, Tr. 762). 

1678. ECM customers frequently run test samples through a battery of performance testing 

to ensure proper manufacturing. (Sinclair, Tr. 761-62). 

1679. Companies become customers of ECM’s additive technology only after months, 

sometimes years, of negotiation and product testing. (Sinclair, Tr. 761-64). 

1680. ECM has to work with customers to get the manufacturing process right, so that 

customers do not scorch the material or manufacture it improperly. (Sinclair, Tr. 

762). 

1681. Because of the lengthy testing and verification processes, it takes on average 

approximately six months to a year (and in some cases several years) for ECM to 

acquire a customer account. (Sinclair, Tr. 767). 

1682. The temperatures used in manufacturing ECM plastics depend on the materials’ glass 

transition and melting temperatures. (Sahu, Tr. 1817). 

1683. The temperature will depend on how the manufacturer would like the viscosity 

properties of the plastic to be during manufacturing, and how they intend to handle 

the melt after heating. (Sahu, Tr. 1817). 
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1684. The ECM additive is introduced into the main plastic resin just like any other 

additive, such as a colorant. (Sahu, Tr. 1818). 

1685. Color additives are sometimes not properly mixed with the plastic, and the 

appearance of the final product clearly shows the inconsistent colors. (Sahu, Tr. 

1818). 

1686. The “dwell time” during manufacturing refers to the residence time, or how long the 

additive is exposed to temperatures during manufacturing. (Sahu, Tr. 1836-37). 

1687. Because ECM plastics are melt-compounded, longer dwell times can cause the plastic 

or additive to denature during manufacturing, which must be carefully avoided to 

ensure additive efficacy. (Sahu, Tr. 1837). 

1688. The “load rate” of the ECM additive is the mass or percent of the additive that 

manufacturers add to a melt. (Sahu, Tr. 1819). 

1689. The customary load ratings for color additives are anywhere from 0.5 percent to 2 or 

3 percent. (Sahu, Tr. 1819-20). 

1690. Plastics made with the ECM additive are manufactured differently than bioplastics. 

(Sahu, Tr. 1821). Bioplastics are more delicate. (Sahu, Tr. 1821). 

1691. The physical properties of a bioplastic also differ in material respects from plastics 

manufactured with the ECM additive. (Sahu, Tr. 1821). 

1692. The crystallinity of the bioplastic differs from the ECM additive. (Sahu, Tr. 1821). 

1693. Because bioplastics are designed to rapidly degrade, they are attractive for some uses 

but unattractive for many other uses. (Sahu, Tr. 1821). 

1694. A primary concern when manufacturing plastics is to make the product function for 

its intended use during the product’s lifespan. (Sahu, Tr. 1822). 

1695. A “biodegradable” plastic must still function as a consumer good during its ordinary 

use, effecting a biodegradable property after disposal. (Sahu, Tr. 1822). 

1696. Bioplastics may not be appropriate for all consumer uses where, for instance, shelflife is important, or where product use is intended for environments that could 

promote biodegradation early. (Sahu, Tr. 1822-23). 

1697. One of the advantages of using the ECM additive is that, at a 1% load rating (like a 

color additive), the additive should not substantially affect the fundamental properties 

of the plastic product. (Sahu, Tr. 1823). 
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1698. The ECM additive gives manufacturers the benefit of usability of the article along 

with biodegradation. (Sahu, Tr. 1823). 

C. Dr. Sahu Testified that Many Factors Can Affect the 

Biodegradable Feature of Plastic Containing the ECM Additive 

1699. Many factors affect the ability of a plastic to biodegrade. (Sahu, Tr. 1828). 

1700. The inclusion of impurities and other additives in a plastic polymer can influence the 

ultimate biodegradability of the plastic. (Sahu, Tr. 1828). 

1701. Some plastic additives (e.g., colorants) may include components that have an 

antimicrobial effect. (Sahu, Tr. 1828-29). 

1702. Impurities are included in the final plastic unintentionally. (Sahu, Tr. 1829-30). 

1703. Impurities may include byproducts from manufacturing. (Sahu, Tr. 1830). 

1704. Impurities affect the biodegradability of plastics by providing attack points in the 

polymer chains. (Sahu, Tr. 1830). 

1705. Those impurities become spots where the plastic is weaker than it would be without 

the impurities, and those weaknesses facilitate microbial attack. (Sahu, Tr. 1831). 

1706. Additives are intentionally added to plastics, but they similarly create heterogeneity in 

the polymer, and create opportunities for biological attack. (Sahu, Tr. 1831). 

1707. Additives may include articles like plasticizers, lubricants, impact modifiers, fillers, 

pigments, flame retardants, stabilizers, and antimicrobial agents. (Sahu, Tr. 1832-33). 

1708. There are additives that can have antimicrobial properties but are not specifically 

introduced to the plastic for antimicrobial purposes. (Sahu, Tr. 1835). 

1709. There are some catalysts, including copper- or zinc- or silver-based components that 

have antimicrobial properties but are not included intentionally as antimicrobials. 

(Sahu, Tr. 1835). 

1710. An antimicrobial additive or impurity would likely reduce or negate biodegradation. 

(Sahu, Tr. 1836). 

1711. Virtually all plastic articles have additives. (Sahu, Tr. 1836). 

1712. In all practical applications, many additives are typically present in the final plastic. 

(Sahu, Tr. 1836). 
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140 

1713. MSW landfills contain widely variable temperature conditions. (Sahu, Tr. 1842-44). 

1714. At a fundamental level, there is no difference in the way thermophilic bacteria 

metabolize waste versus the way mesophilic bacteria metabolize waste (Sahu, Tr. 

1844). 

1715. The particular enzymes involved, however, are different, as is the rate of 

biodegradation. (Sahu, Tr. 1843-44). 

1716. All MSW landfills have the potential to produce gases, and those gases are a 

signature of biological activity. (Sahu, Tr. 1846). 

1717. The gases generated from MSW landfills show that there are biological reactions 

occurring, and so the gases are indicative of underlying biological activity in the 

landfill. (Sahu, Tr. 1847). 

1718. In context with landfill or test gases, there can be no methane without anaerobic 

biodegradation. (Sahu, Tr. 1848). 

1719. Dr. Sahu examined the “threshold question” of whether plastics or polymers are 

capable of biodegrading. (Sahu, Tr. 1848). 

1720. He performed an extensive literature search. (Sahu, Tr. 1848-49). 

1721. Dr. Sahu’s research was memorialized in his expert report. (Sahu, Tr. 1849; RX 855 

at 24-40). 

1722. Dr. Sahu has described the mechanism of action by which the ECM additive 

accelerates biodegradation of plastics. (Sahu, Tr. 1857-58). 

1723. The rate of biodegradation of plastic polymers depends on many variables, including 

the various properties of the base plastic, the presence and types of amounts of 

biological organisms in the vicinity of the plastic material, and the properties of the 

local physical environment. (RX 855 at 27). 

1724. The ECM additive helps to set in motion the attraction/migration of microbes and 

biological agents to the plastic, and to the areas of the plastic where weaknesses or 

hydrophilic defects exist. (RX 855 at 27; Sahu, Tr. 1865-67). 

1725. The formation of biofilms near the additive sites promotes the development and 

growth of bacteria, which spreads to other areas of the plastic. (RX 855 at 27). 

1726. Depending on the linear chains and branches within a polymer, biological activity 

typically begins at the weak points and endings of a polymer chain, and works into 

the remaining portions of the polymer. (Sahu, Tr. 1866-67). 
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141 

1727. Microbes secrete enzymes and chemicals that degrade plastic where the biofilms are 

present, beginning with the weak links in plastic. (RX 855 at 27). 

1728. Dr. Sahu relied on peer reviewed literature to demonstrate that plastic polymers 

biodegrade, including crystalline regions therein. (RX 855 at 24-40). 

1729. Dr. Sahu reviewed hundreds of papers in preparation of his expert report, including 

the eleven that he quoted and relied upon in the text of his report. (RX 855 at 24-40). 

1730. Those include: (1) Tokiwa, Y., et al., Biodegradability of Plastics, Int. J. Mol. Sci. 

2009, 10, 3722-3742; (2) Tilstra, L., et al., The Biodegradation of Blends of 

Polycaprolactone and Polyethylene Exposed to a Defined Consortium of Fungi, 

Journal of Environmental Polymer Degradation, Vol. 1, No. 4, 1993; (3) Zheng, Y., et 

al., A Review of Plastic Waste Biodegradation, Critical Reviews in Biotechnology, 

25:243–250, 2005; (4) Bhardwaj H, Gupta R, Tiwari A (2012) Microbial Population 

Associated With Plastic Degradation. 1: 272. doi:10.4172/scientificreports; (5) 

Arutchelvi, J., et. al., Biodegradation of polyethylene and polypropylene, Indian 

Journal of Biotechnology, Vol. 7, January 2008, p. 9-22; (6) Mueller, R-J., Biological 

degradation of synthetic polyesters—Enzymes as potential catalysts for polyester 

recycling, Process Biochemistry, Volume 41, Issue 10, October 2006, p. 2124–2128; 

(7) Van der Zee, M., Analytical Methods for Monitoring Biodegradation Processes of 

Environmentally Degradable Polymers, Section 11.4.2; (8) Shah, A.A., et. al., 

Biological degradation of plastics: A comprehensive review, Biotechnology 

Advances Vol. 26, 2008, p. 246–265; (9) Pramila, R., et. al., Biodegradation of Low 

Density Polyethylene (LDPE) by Fungi Isolated from Municipal Landfill Area, J. 

Microbiol. Biotech. Res., 2011, 1 (4):131-136; (10) Albertsson, A-C., Biodegradation 

of synthetic polymers. II. A limited microbial conversion of 14C in polyethylene to 

14CO2 by some soil fungi, Journal of Applied Polymer Science, Volume 22, Issue 

12, p. 3419–3433, December 1978; and (11) Albertsson, A-C., et. al., Biodegradation 

of synthetic polymers. III. The liberation of 14CO2 by molds like fusarium redolens 

from 14C labeled pulverized high-density polyethylene, Journal of Applied Polymer 

Science, Volume 22, Issue 12, p. 3435–3447, December 1978. 

1731. Based on his experience and research, Dr. Sahu determined that peer reviewed 

literature demonstrated that beyond aerobic biodegradation, anaerobic processes are 

capable of biodegrading conventional plastics. (Sahu, Tr. 1858-59). 

1732. The biodegradation of plastic polymers involves, inter alia, hydrolytic cleavage of 

polymer bonds. (Sahu, Tr. 1859-60). 

1733. The hydroxyl radical (OH radical) is capable of facilitating hydrolytic reactions. 

(Sahu, Tr. 1860). 

1734. Oxidative reactions involve electron transfer. (Sahu, Tr. 1860). 
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1735. Oxidative reactions need not occur in the presence of oxygen. (Sahu, Tr. 1861). 

1736. Oxidative reactions occur in anaerobic systems. (Sahu, Tr. 1862). 

1737. Pro-oxidants can facilitate biodegradation, but they are not the only mechanisms that 

work to degrade polymers. (Sahu, Tr. 1870-73). 

1738. Many forms of polymer biodegradation have been documented in the peer reviewed 

literature. (Sahu, Tr. 1875). 

1739. Blending biodegradable and non-biodegradable polymers is one of the means 

documented in the peer reviewed literature by which polymers can be rendered 

biodegradable. (Sahu, Tr. 1876; RX 925 at 647). 

1740. The scientific literature shows that polymer chains with molecular weights as high as 

10,000 can be biodegraded. (Sahu, Tr. 1872-73). 

1741. As molecular weights decrease through microbial biodegradation, the susceptibility of 

polymers to further biodegradation increases. (Sahu, Tr. 1873). 

1742. Because the ECM additive is uniformly dispersed throughout an ECM plastic, the 

additive’s effect is not limited to a surface effect. (Sahu, Tr. 1863-64). 

1743. Because the ECM additive is uniformly dispersed throughout an ECM plastic, the 

additive provides a continued food source for microbial growth through plastic 

degradation. (Sahu, Tr. 1863-64). 

1744. The presence of the ECM additive throughout the plastic provides for continued and 

complete biodegradation of the conventional plastic. (Tr. 1864-65). 

1745. MSW landfills contain bacteria, fungi, and other microorganisms that secrete 

enzymes capable of completing the biodegrading processes that Dr. Sahu identified in 

his expert report. (Sahu, Tr. 1865-66). 

1746. Those microorganisms have evolved over time, and can evolve quickly, to adapt for 

plastics biodegradation. (Sahu, Tr. 1880-81). 

1747. Scientists in the field have published information concerning the types of bacteria and 

microorganisms that are found in nature (including MSW landfills), which have also 

been shown to biodegrade conventional plastics. (Sahu, Tr. 1867-68; RX 855 at 34). 

1748. Those microorganisms are found in landfills, sewage treatment plants, digesters, and 

compost piles. (Sahu, Tr. 1869). 
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1749. Plastic polymers can have amorphous and crystalline regions. (Sahu, Tr. 1883-84). 

Crystalline portions of the polymer can be biodegraded just as the amorphous regions 

can, but perhaps at a different rate. (Sahu, Tr. 1884-85). 

1750. Crystalline portions of polymers are still fundamentally composed of the same chains. 

(Sahu, Tr. 1884). 

1751. Those polymer regions are actually semi-crystalline. (Sahu, Tr. 1884). 

1752. Scientists have examined the biodegradability of crystalline portions of polymers and 

found that they do in fact biodegrade. (Sahu, Tr. 1885). 

1753. Literature in the peer review has discussed the loss of crystallinity or decreases in 

crystallinity, or loss of the lamellae that are the crystalline subcomponents as 

indicators that degradation has occurred in the crystalline portions of plastics. (Sahu, 

Tr. 1885). 

1754. In the article titled, Arutchelvi, J., et. al., Biodegradation of polyethylene and 

polypropylene, Indian Journal of Biotechnology, Vol. 7, January 2008, p. 9-22, the 

authors focused on polyethylene and polypropylene. (Sahu, Tr. 1885-85; RX 855 at 

35; RX 586). 

1755. The article included discussion and citations to other literature wherein scientists have 

observed loss of crystallinity in conventional plastics. (Sahu, Tr. 1885-86; RX 586; 

RX 855 at 35). 

1756. Scientists have posited that biodegradation begins in amorphous regions of the 

polymers. (RX 586 at 13). 

1757. However, the peer reviewed literature also supports that crystalline regions will 

biodegrade. (RX 855 at 28, 41 n. 62). 

1758. The amorphous regions of a polymer are more susceptible to degradation, but while 

the crystalline sections of a polymer are “more resistant than the amorphous region,” 

they will also degrade in kind. (RX 855 at 28 (quoting Tokiwa, Y., et al., 

Biodegradability of Plastics, Int. J. Mol. Sci. 2009, 10, 3722-3742; RX 582). 

1759. For example, Tokiwa, Y., et al. (RX 582) have explained that certain enzymes have 

been shown to biodegrade “both the amorphous and crystalline” portions of plastics. 

(RX 582 at 3732 (discussing the lipase enzymatic degradation of PCL)). 

1760. The degree of crystallinity is merely one of many factors that can influence the 

biodegradability of plastics. (RX 582 at 3722). 
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1761. Even plastics with high degrees of crystallinity can be more biodegradable than others 

with lesser degrees of crystallinity if other factors promote biodegradability, such as 

surface area, molecular weight distribution, melting point, etc. (Sahu, Tr. 1886; RX 

582 at 3722). 

1762. It is a scientific error to use the crystallinity of a polymer as the only factor or 

variable that governs whether a plastic will biodegrade. (Sahu, Tr. 1887). 

1763. “Thermoplastics are invariably composed of long, individual molecules that are 

bonded to each other by secondary chemical bonds, which are much weaker than the 

primary covalent bonds that hold the molecules together.” (RX 855 at 15 (quoting 

Lampman, S., Characterization and Failure Analysis of Plastics, ASM International, 

2003, p.7)). 

1764. Thermoplastics “overall structure is generally amorphous, but some thermoplastics 

can become partly crystalline.” (RX 855 at 15 (quoting Lampman, S., 

Characterization and Failure Analysis of Plastics, ASM International, 2003, p.7)) 

(emphasis added). 

1765. Polyethylene, polypropylene, polyvinyl chloride, and polystyrene are all 

thermoplastics (RX 855 at 31), which have an “overall structure that is generally 

amorphous” (RX 855 at 15 (quoting Lampman, S., Characterization and Failure 

Analysis of Plastics, ASM International, 2003, p.7)). 

XIII. GAS EVOLUTION TESTS ARE COMPETENT AND RELIABLE EVIDENCE, 

AND RADIOLABELED TESTING IS NOT REQUIRED 

1766. Dr. McCarthy’s use of gas evolution tests similar to the D5511 protocol to establish 

proof or biodegradability in his own technologies is in direct conflict with his 

testimony offered in this case, wherein he claims that such tests are only screening 

mechanisms. (Sahu, Tr. 1894-95). 

1767. Dr. McCarthy has not used radiolabeled testing to establish proof of biodegradability. 

(Sahu, Tr. 1895). 

1768. Dr. Sahu explained that gas evolution tests are competent and reliable scientific 

evidence to prove biodegradability. (Sahu, Tr. 1895-96). 

1769. Other methods of testing can help to provide supporting evidence, including, for 

instance, weight loss or gravimetric testing. (Sahu, Tr. 1895-96). 
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145 

1770. There is no indication in the scientific literature or from scientists in the field that 

radiolabeled testing is necessary to establish proof of biodegradability. (Sahu, Tr. 

1896). 

1771. When questioned about the type of evidence required to support biodegradability, Dr. 

Tolaymat did not mention radiolabeled testing. (Tolaymat, Tr. 112-347). 

1772. When assessing the biodegradability of plastic products, Dr. Michel chose to perform 

several gas evolution tests, but he did not perform radiolabeled testing. (Michel, Tr. 

2906). 

1773. Dr. Michel has never tested a plastic polymer using radiolabeled testing. (Michel, Tr. 

2906). 

1774. At his deposition, Dr. Tolaymat explained that radiolabeled testing “could be as 

expensive as doing it in a landfill – as doing the study in a landfill environment” and 

that “it’s not used frequently.” (RX 851 (Tolaymat, Dep. at 256)). 

1775. Dr. Michel testified that respirometric testing, like the D5511 test, is generally 

recognized in the field as competent and reliable evidence to show biodegradation. 

(Michel, Tr. 2907). 

1776. Dr. Sahu found no evidence that radiolabeled testing is generally accepted as a 

requirement to biodegradability testing for polymers. (Sahu, Tr. 1794-95). 

1777. In the pre-complaint phase of this case, Dr. Sahu searched for a commercial 

laboratory that could perform radiolabeled testing for ECM. (Sahu, Tr. 1897-98). 

1778. Dr. Sahu could not find any company able to radiolabel the polymer or create the 

radiolabeled polymer that would then be subject to further laboratory testing. (Sahu, 

Tr. 1897). 

1779. Many companies could offer radiolabeled pharmaceutical ingredients, but not 

polymers, which required a different manufacturing process. (Sahu, Tr. 1898-99). 

1780. Pharmaceutical ingredients are tested in minute quantities. (Sahu, Tr. 1899). 

1781. Radiolabeled testing starts when a laboratory receives a radiolabeled substance which 

is barium salt. (Sahu, Tr. 1900). 

1782. That barium salt is derived from research reactors. (Sahu, Tr. 1900). Only a few 

research facilities in the world can provide the radioactive source materials. (Sahu, 

Tr. 1900). 

1783. Carbon-14 is evolved from the salt in carbon dioxide. (Sahu, Tr. 1900). 
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146 

1784. Carbon-14 is then synthesized, and the laboratory will have minute quantities of 

radiolabeled carbon. (Sahu, Tr. 1900). 

1785. In plastics testing, a laboratory must then synthesize monomers with the radiolabeled 

carbon, then polymerize those monomers into a polymer chain that contains the 

radiolabeled carbon. (Sahu, Tr. 1900-01). 

1786. Most polymers, like polyethylene, are sourced by large scale facilities which derive 

the feedstock material from petrochemicals. (Sahu, Tr. 1901). 

1787. When a source plastic like polyethylene is radiolabeled, the entire source plastic can 

be radiolabeled. (Sahu, Tr. 1901). 

1788. That means both the amorphous and crystalline regions are radiolabeled. (Sahu, Tr. 

1901). 

1789. The manufacturer must then make the test plastic as it would appear in commerce, but 

with the radiolabeled base polymer. (Sahu, Tr. 1901). 

1790. Once the radiolabeled test plastic is assembled, it must still be tested in a standard 

biodegradation test. (Sahu, Tr. 1901). 

1791. That testing is the same gas evolution testing that would otherwise be done without 

the radiolabeled polymer. (Sahu, Tr. 1906). 

1792. The company that manufacturers the radiolabeled polymer is not the same company 

that would perform the biodegradation testing. (Sahu, Tr. 1902). 

1793. There are difficulties associated with handling radioactive carbon. (Sahu, Tr. 1903). 

1794. Aside from the regulatory issues, the laboratory must be capable and prepared to 

handle the radioactive material and ensuing decontamination. (Sahu, Tr. 1903). 

1795. A testing laboratory would require a considerable amount of carbon-14 to test plastics 

for biodegradation because the manufacturer must create a commercial-scale product 

for testing. (Sahu, Tr. 1903). 

1796. That amount is much more than pharmaceutical companies would use in a test of an 

active pharmaceutical ingredient. (Sahu, Tr. 1903-04). 

1797. Even assuming that Dr. McCarthy’s concerns over recalcitrant crystalline sections of 

the polymers was valid, carbon-14 testing would not address his points. (Sahu, Tr. 

1904). 

1798. A radiolabeled test would need to have carbon-14 radiolabeled throughout the 

amorphous and crystalline sections. (Sahu, Tr. 1904-05). 
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147 

1799. Complaint Counsel’s experts provided no testimony or evidence as to how, if at all, a 

company would radiolabel specifically the crystalline sections but not amorphous 

sections of a polymer. (McCarthy, Tr. 359–689). 

1800. Dr. Sahu testified that it would be impossible to radiolabel only the crystalline 

sections of a polymer. (Sahu, Tr. 1906). 

1801. There is no evidence in the market or in the peer reviewed literature that carbon-14 

radiolabeled testing is an industry standard. (Sahu, Tr. 1905). 

1802. In-situ landfill studies generally cannot be conducted as gas evolution tests. (Sahu, 

Tr. 1909). 

1803. A landfill test can measure changes to physical properties, but not gas evolution. 

(Sahu, Tr. 1909). 

1804. “Accelerated testing” is scientifically acceptable when trying to mimic a slow natural 

process in the lab; practicalities require that results come faster than would normally 

occur in nature. (Sahu, Tr. 1924). 

1805. Accelerated testing is done in engineering, biology, drug testing, and many other 

scientific fields. (Sahu, Tr. 1924). 

1806. In engineering studies, for example, abbreviated tests are designed to test against 

stresses that would be experienced over a lifetime of use. (Sahu, Tr. 1925). 

1807. Accelerated testing is appropriate for biodegradation studies because the results under 

normal time would otherwise require substantially extended test periods. (Sahu, Tr. 

1924). 

1808. Accelerated laboratory testing is a competent and reliable means to assess intrinsic 

biodegradability of materials. (Sahu, Tr. 1926-27). 

1809. Based on the totality of the scientific evidence, Dr. Sahu testified that conventional 

plastic containing the ECM additive render the plastic “biodegradable in a landfill.” 

(Sahu, Tr. 1943-44). 

XIV. DR. MORTON BARLAZ’S TESTIMONY 

A. Dr. Barlaz Testified that Biodegradation Occurs in MSW 

Landfills 
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148 

1810. Dr. Morton Barlaz testified that significant anaerobic biodegradation occurs in 

municipal solid waste landfills, and the prime evidence for that is the production of 

methane in those landfills. (Barlaz, Tr. 2174). 

1811. There are about 2,000 municipal waste landfills in the U.S., and commercial 

quantities of methane are recovered from at least 600, which evidences the significant 

anaerobic biodegradation occurring in the landfills. (Barlaz, Tr. 2174). 

1812. There is a significant amount of methane emissions that come from municipal solid 

waste. (Barlaz, Tr. 2174-75). 

1813. Methane is the end product of biodegradation in landfills. (Barlaz, Tr. 2174). 

1814. Dr. Barlaz testified that, based on his review of laboratory reports relevant to this 

case, there were numerous examples where specific ECM amended plastics were 

shown to anaerobically biodegrade to methane. (Barlaz, Tr. 2175). 

1815. Municipal solid waste is highly heterogeneous. (Barlaz, Tr. 2175). 

1816. Estimates of waste composition should be understood to be rough estimates. (Barlaz, 

Tr. 2175-76). 

1817. EPA’s estimates of waste composition should not be considered precise. (Barlaz, Tr. 

2177). 

1818. MSW is waste that is generated in the residential, commercial, and institutional 

sectors. (Barlaz, Tr. 2177). 

1819. Landfilling is really the only disposal alternative. (Barlaz, Tr. 2178). 

1820. Burning or incinerating is not a waste disposal alternative, it is waste treatment. 

(Barlaz, Tr. 2178). 

1821. Combustion and landfilling are the only two viable disposal alternatives. (Barlaz, Tr. 

2179). 

1822. Some part of the waste stream is recycled, and some is treated biologically either in 

composting or in a few cases anaerobic digestion. (Barlaz, Tr. 2179). 

1823. However, composting is largely confined to yard waste, grass, leaves, and branches, 

and there are very few communities in the U.S. that separate out compostable waste. 

(Barlaz, Tr. 2179). 

1824. Over the last five to ten years, many residential recycling programs have expanded to 

accept more materials. (Barlaz, Tr. 2179-80). 
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1825. Because paper is the largest component of municipal solid waste, the more paper that 

comes out of the waste stream for disposal means that the waste stream is enriched 

with other components, like food waste. (Barlaz, Tr. 2180). 

1826. Dr. Barlaz has summarized waste sort data from ten states in his published research. 

(Barlaz, Tr. 2181-82). 

1827. Paper still comprises about 20 percent of the total MSW composition, roughly 20 

percent is food waste, plastics comprise about 10 percent, and 3 to 5 percent is glass. 

(Barlaz, Tr. 2181). 

1828. Because consumers and commercial entities sort and recycle waste, the composition 

of waste generated will differ from the composition of waste disposed. (Barlaz, Tr. 

2182). 

1829. Municipal solid waste contains chemical compounds that have methane potential. 

(Barlaz, Tr. 2183). 

1830. Anaerobically biodegradable materials have the potential to generate methane. 

(Barlaz, Tr. 2183-84). 

1831. Stoichiometry is the relationship between the chemical composition of reactants of an 

equation (those materials on the left side), and the end products (the materials on the 

right side). (Barlaz, Tr. 2185). 

1832. Principles of stoichiometry deal with conservation of mass, and are applicable to the 

conversion of substrates to methane during anaerobic biodegradation. (Barlaz, Tr. 

2185-86). 

1833. To microorganisms, municipal solid waste represents a source of food or energy, so if 

there is energy to be gained by consuming or attacking a substrate, they will do it. 

(Barlaz, Tr. 2186). 

1834. In general, the process of anaerobic biodegradation involves hydrolysis reactions that 

eventually produce products such as butyric acid, acetic acid, hydrogen, and carbon 

dioxide. (Barlaz, Tr. 2186). 

1835. Butyric acid is then attacked by microorganisms referred to as acetogenic, which 

convert the butyric acid to acetic acid and carbon dioxide. (Barlaz, Tr. 2187). 

1836. Methanogenic archaea use either the acetic acid or hydrogen plus carbon dioxide and 

convert either of those substances to methane. (Barlaz, Tr. 2187). 

1837. The concerted activity of at least four trophic groups of microorganisms enable the 

conversion of materials to methane and carbon dioxide. (Barlaz, Tr. 2187). 
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1838. Microbes may secrete some waste products of metabolism to the environment as a 

product of biodegradation. (Barlaz, Tr. 2188). 

1839. Cell mass is also a product of biodegradation, meaning that carbon extracted from 

waste may consume the carbon for growth rather than convert carbon to methane or 

gas. (Barlaz, Tr. 2188). 

1840. Methane is only produced in a system that is strictly anaerobic. (Barlaz, Tr. 2188). 

1841. In an anaerobic test system, the ratio of methane gas to carbon dioxide is usually in 

the range of 1:1, but may appear more like 60% methane and 40% carbon dioxide 

because carbon dioxide can dissolve into the liquid phase. (Barlaz, Tr. 2189). 

1842. There is oxygen in landfills, to the extent that it comes from waste materials, water, 

and other chemicals. (Barlaz, Tr. 2189-90). 

1843. For example, there is oxygen in cellulose. (Barlaz, Tr. 2190). 

1844. Every reaction in which a microbe gains energy or has a source of energy is an 

oxidative reaction. (Barlaz, Tr. 2190). 

1845. Oxidative reactions need not involve oxygen, and they occur in anaerobic systems. 

(Barlaz, Tr. 2191-92). 

1846. Landfills can produce substantial amounts of methane gas emissions. (Barlaz, Tr. 

2192-93). 

1847. Dr. Barlaz has seen landfills that make 250 to 500 cubic feet of landfill gas (at 50% 

methane) per minute. (Barlaz, Tr. 2192). 

1848. The EPA’s Landfill Methane Outreach Program (LMOP) runs a voluntary database of 

landfills for recovering methane. (Barlaz, Tr. 2193-94). 

1849. Dr. Barlaz has been to landfills making eight to ten thousand cubic feet of landfill gas 

per minute. (Barlaz, Tr. 2193). 

1850. The volume of gas depends on the mass of waste disposed annually and other factors 

like the moisture content and waste composition. (Barlaz, Tr. 2193). 

1851. Dr. Barlaz explained that it is very, very difficult to describe a “typical” landfill. 

(Barlaz, Tr. 2193). 

1852. Dr. Barlaz explained that Dr. Tolaymat’s opinion was misleading because Dr. 

Tolaymat suggested that biodegradation only occurs in bioreactor landfills, and Dr. 

Tolaymat also adopted a very narrow definition of bioreactor landfill. (Barlaz, Tr. 

2196). 
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1853. The EPA’s definition of a bioreactor landfill is very narrow, and it is a misleading 

definition because Dr. Barlaz has been to many landfills that do not describe 

themselves as “bioreactors” but still produce substantial methane generation. (Barlaz, 

Tr. 2196-97). 

1854. Dr. Barlaz explained that the simplest analysis is that there are “620 landfills that are 

generating enough methane for people to make million-dollar investments in 

equipment to convert that methane to electrical energy or some other beneficial use. 

And that, to [Dr. Barlaz], contrasts considerably with this notion that there are only 

40 landfills with significant biodegradation occurring.” (Barlaz, Tr. 2197). 

1855. Dr. Barlaz testified that the term “dry tomb landfill” is misused because the 

implication of the term and the implication of Dr. Tolaymat’s report was that if a 

landfill is not actively adding moisture to a landfill, then it is a dry tomb landfill, 

which is false. (Barlaz, Tr. 2198). 

1856. Dr. Barlaz had been to many landfills that are not actively adding leachate or external 

liquids to the landfill, and yet by virtue of infiltration of rainwater alone the landfills 

have considerable moisture, and they are making considerable methane. (Barlaz, Tr. 

2198). 

1857. The EPA Subtitle D regulations do not specify the hydraulic conductivity of the soil 

that is used to cover the landfill waste daily or weekly or even annually. (Barlaz, Tr. 

2199). 

1858. The EPA Subtitle D regulations only specify hydraulic conductivity of the soil that 

used as a final cover on the landfill. (Barlaz, Tr. 2199). 

1859. The hydraulic conductivity is a measure of how much water infiltrates. (Barlaz, Tr. 

2199). 

1860. There are thus many landfills that by virtue of infiltration alone are not “dry tomb” 

landfills. (Barlaz, Tr. 2199). 

1861. The implication that those landfills are not making methane is misleading and not 

correct. (Barlaz, Tr. 2199). 

1862. More and more landfills are now recirculating leachate or taking in commercial 

liquids from other sources and adding it to waste. (Barlaz, Tr. 2200). 

1863. Those landfills are operating to enhance waste decomposition. (Barlaz, Tr. 2200). 

1864. Landfills are also spraying waste with leachate as the waste goes into the landfill, 

which also accelerates biodegradation. (Barlaz, Tr. 2200). 
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1865. Dr. Barlaz recently performed a landfill gas study on more than fifteen landfills 

around the country. (Barlaz, Tr. 2201). 

1866. He found that more than two-thirds of those landfills were spray-applying leachate to 

the working face of the landfill, although those landfills were not calling themselves 

“bioreactors.” (Barlaz, Tr. 2201). 

1867. Landfill operators have financial incentives to recycle leachate and increase moisture 

content. (Barlaz, Tr. 2202-03). 

1868. The cost of landfill leachate treatment is substantial, and landfill operators can save 

those costs by recirculating leachate. (Barlaz, Tr. 2202-03). 

1869. Wastewater treatment plants have started informing landfill operators that they will 

no longer accept landfill leachate, forcing landfill operators to consider alternatives 

like leachate recirculation. (Barlaz, Tr. 2203). 

1870. Some landfill operators must transport leachate hundreds of miles for processing, 

which adds to operating costs. (Barlaz, Tr. 2203). 

1871. Landfills contain pockets of dry and very moist areas. (Barlaz, Tr. 2205). 

1872. The range of moisture content in landfills can be considerable. (Barlaz, Tr. 2206). 

1873. The range of temperatures in MSW landfills is also significant. (Barlaz, Tr. 2207). 

1874. Dr. Barlaz has seen landfills where steam has been emitted from landfills, while on 

the other side of the same landfill, the temperatures at the gas heads might be in the 

range of 100 degrees Fahrenheit. (Barlaz, Tr. 2208). 

1875. Landfill recirculation increases overall moisture content, and also helps balance the 

moisture levels in the same landfill. (Barlaz, Tr. 2205). 

1876. Landfill leachate is diverse, and contains carboxylic acids, humic matter, ammonia, 

and other chemicals. (Barlaz, Tr. 2203-04). 

1877. Landfill leachate carries microorganisms. (Barlaz, Tr. 2204). 

1878. Landfill leachate has nutrients in the form of dissolved ammonia and phosphate, 

which are major nutrients or macronutrients, and it also contains trace metals which 

are nutrient sources for microorganisms. (Barlaz, Tr. 2204-05). 

1879. A landfill might collect around 300 gallons per acre per day of landfill leachate in a 

typical MSW landfill. (Barlaz, Tr. 2205-06). 

1880. The 300 gallon figure is conservative. (Barlaz, Tr. 2206). 
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1881. Dr. Barlaz testified that ten years ago the rule was about 1,100 gallons per acre per 

day. (Barlaz, Tr. 2206). 

1882. In the field (in actual landfills), Dr. Barlaz explained that there is no moisture level at 

which biodegradation would not occur. (Barlaz, Tr. 2208). 

1883. Research concerning the microbiology of refuse decomposition in the laboratory is 

“accelerated.” (Barlaz, Tr. 2212). 

1884. Without accelerated testing, lab tests for biodegradation could take anywhere from 5 

to 500 years. (Barlaz, Tr. 2212). 

1885. It is not practical to try to simulate the landfill ecosystem at that time scale in a 

laboratory. (Barlaz, Tr. 2212). 

1886. In a landfill environment, the microorganisms are capable of balancing the ecosystem 

if it becomes too acidic of basic. (Barlaz, Tr. 2213). 

1887. The average landfill accepts waste for about 35 years. (Barlaz, Tr. 2215). 

1888. The landfill is then closed with a “final cover” consisting of low-permeability layers 

to contain gas within the waste and restrict moisture infiltration. (Barlaz, Tr. 2216). 

1889. Some landfills will remain open for as long as 50 years, but the final number is sitespecific. (Barlaz, Tr. 2216). 

1890. Landfills continue to produce gas after closure. (Barlaz, Tr. 2217). 

1891. Dr. Barlaz explained that whether and to what extent a material biodegrades can be 

considered to be an intrinsic property of the material. (Barlaz, Tr. 2217-18). 

1892. Dr. Barlaz used the term “intrinsic anaerobic biodegradability” to describe a property 

of the material, much like its color or weight or density. (Barlaz, Tr. 2218). 

1893. The intrinsic biodegradability of a material will not change regardless of where the 

material is placed. (Barlaz, Tr. 2218). 

1894. Changes to environmental temperature or moisture do not change the intrinsic 

biodegradability of a material. (Barlaz, Tr. 2218). 

1895. Dr. Barlaz used the example of a piece of paper which, while biodegradable, would 

not biodegrade in a courtroom if held there for hundreds of years. (Barlaz, Tr. 2218). 

1896. The biodegradable nature of the paper will not change simply because it is in the 

courtroom setting. (Barlaz, Tr. 2218-19). 
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1897. The point of biodegradation testing is to put the material in an environment that is 

favorable for biodegradation. (Barlaz, Tr. 2219). 

1898. The ASTM D5511 test method is competent and reliable to test for intrinsic 

biodegradability. (Barlaz, Tr. 2219). 

B. Dr. Barlaz Testified that Gas Evolution Tests are Competent and 

Reliable to Prove Biodegradability 

1899. Dr. Barlaz differentiates between a “BMP” test (or “biochemical methane potential”) 

and “reactor-scale tests.” (Barlaz, Tr. 2220). 

1900. The BMP test is performed in a small 160 milliliter glass vial, while reactor-scale 

tests are larger and more dynamic environments. (Barlaz, Tr. 2220). 

1901. BMP testing can be modified from lab to lab. (Barlaz, Tr. 2220-21). 

1902. Some of the modifications commonly seen involve the preparation of the test sample, 

or screening the material by passing it through a 1mm screen. (Barlaz, Tr. 2221). 

1903. Passing a material through a 1mm screen renders the material the consistency of 

wheat flour. (Barlaz, Tr. 2221). 

1904. Other adaptations to the BMP test include changes to temperature or duration of the 

test. (Barlaz, Tr. 2221-22). 

1905. When running a BMP test, Dr. Barlaz uses about one gram of substrate to a hundred 

milliliters of liquid, so the environment is essentially “pure liquid,” a “liquid phase 

test.” (Barlaz, Tr. 2222). 

1906. The ASTM D5511 test is a laboratory-scale reactor test. (Barlaz, Tr. 2222-23). 

1907. As compared to the BMP test, a laboratory-scale reactor test is performed in a “highsolids environment,” and it is “more representative of a high-solids matrix as we see 

in a landfill.” (Barlaz, Tr. 2224). 

1908. Dr. Barlaz testified that “what we see in a reactor is representative of what’s possible 

in a landfill if conditions in the landfill are suitable for anaerobic biodegradation.” 

(Barlaz, Tr. 2224). 

1909. The methodology involved in laboratory-scale reactor testing starts with a 

composition of “inoculum” from well-decomposed refuse or municipal waste. 

(Barlaz, Tr. 2224-25). 
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1910. Water is added to the system to achieve the requisite moisture levels. (Barlaz, Tr. 

2225). 

1911. The laboratory monitors the pH, and other variables in the leachate or solution. 

(Barlaz, Tr. 2225). 

1912. The system is designed to capture gas that is generated in the vessels, including the 

methane and carbon dioxide in the gas, which is used to calculate the methane 

generation rate. (Barlaz, Tr. 2225). 

1913. Controls are used with the laboratory-scale reactors, including an inoculum blank that 

includes nothing but the decomposed municipal solid waste so that the laboratory can 

measure the background methane attributable to the inoculum alone. (Barlaz, Tr. 

2225-26). 

1914. The laboratory “corrects” for background methane attributable solely to the inoculum 

by subtracting the amount of gas produced by the inoculum blank. (Barlaz, Tr. 2225-

26). 

1915. Theoretical methane potential is calculated simply from the chemical formula and the 

chemical composition of the test materials using stoichiometry. (Barlaz, Tr. 2226). 

1916. The Buswell equation is used to calculate methane potential of a substrate. (Barlaz, 

Tr. 2227). 

1917. The Buswell equation is a balanced equation that looks at how much carbon, 

hydrogen, oxygen, nitrogen and sulfur is in a compound, and it stoichiometrically 

converts those amounts to methane and carbon dioxide (and ammonia and some 

hydrogen sulfide). (Barlaz, Tr. 2227). 

1918. “Mesophilic” refers to a class of microorganisms that have optimal temperature 

around 98.6 degrees Fahrenheit. (Barlaz, Tr. 2228). 

1919. At temperatures above 43 to 44 degrees, mesophiles are killed off or severely 

inhibited. (Barlaz, Tr. 2228). 

1920. “Thermophiles” have an optimal temperature closer to 60 degrees Centigrade. 

(Barlaz, Tr. 2228). 

1921. The Buswell equation does not factor temperature. (Barlaz, Tr. 2228). 

1922. Mesophilic versus thermophilic would primarily influence the rate of degradation. 

(Barlaz, Tr. 2228). 
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1923. In a laboratory-scale reactor test, the Buswell equation is used along with the actual 

methane observed to calculate the percentage of methane realized from the test 

substrate. (Barlaz, Tr. 2229). 

1924. Dr. Barlaz explained that BMP tests are traditionally run for 60 days, however over 

the years he has come to appreciate that shorter term testing for “more slowly 

degradable components of the waste” is likely not appropriate. (Barlaz, Tr. 2230). 

1925. By performing shorter term studies, the tests are not “in fact measure[ing] the total 

methane potential” of a substrate. (Barlaz, Tr. 2230). 

1926. A difference between a BMP and a reactor test is the frequency of gas measurement. 

(Barlaz, Tr. 2230). 

1927. In a laboratory-scale reactor test, the laboratory is typically measuring the gas weekly. 

(Barlaz, Tr. 2230). 

1928. Dr. Barlaz testified that the challenge with “slowly degradable material” is 

understanding that it is slowly degradable in designing the test. (Barlaz, Tr. 2231). 

1929. There are variables or conditions in laboratory-scale reactor tests, like system pH, that 

can depress the activity of microorganisms if not controlled. (Barlaz, Tr. 2231-32). 

1930. Laboratories must also ensure that they have suitable inoculum that is healthy enough 

to initiate anaerobic biodegradation. (Barlaz, Tr. 2232). 

1931. An inoculum that is over-digested before biodegradation testing would limit 

biodegradation because there may not be enough substrate to maintain healthy 

microbial populations and, so, the inoculum would not be effective for initiated tests. 

(Barlaz, Tr. 2232-33). 

1932. The most common compounds inhibitory of microorganisms in the closed-system 

biodegradation test are the carboxylic intermediates (the propionate, butyrate, and 

acetate) which can accumulate. (Barlaz, Tr. 2234; RX 853 at 20 (figure 2)). 

1933. Another class of inhibitory compounds could be a test substrate that has something 

inhibitory (e.g., additive or impurity) that leaches out and is a microbial inhibitor. 

(Barlaz, Tr. 2234; Sahu, Tr. 1836). 

C. Dr. Barlaz Testified that Complaint Counsel’s Theory on In Situ 

and Lysimeter Studies is Not Supported 
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1934. Dr. Barlaz “strongly disagree[d]” with Dr. Tolaymat’s opinion that in situ landfill 

testing was important to document the anaerobic biodegradability of a material. 

(Barlaz, Tr. 2236). 

1935. Dr. Barlaz testified that you cannot get quantitative information on anaerobic 

biodegradability out of an in situ landfill test even if it was done perfectly, and the 

possibility of doing it perfectly is slight at best. (Barlaz, Tr. 2236). 

1936. Dr. Barlaz explained that Dr. Tolaymat had referenced lysimeter testing that Dr. 

Barlaz himself performed with Chris Bareither at the University of Wisconsin. 

(Barlaz, Tr. 2236). 

1937. Dr. Tolaymat incorrectly implied that Dr. Barlaz and Chris Bareither had measured 

methane generation in the lysimeter test when in fact they did not measure methane 

generation at all. (Barlaz, Tr. 2237). 

1938. According to Dr. Barlaz, “whether it is that large-scale column [lysimeter] or whether 

you’re burying waste in a landfill, to me, the way that you document anaerobic 

biodegradability is you measure methane and CO2 production that you can attribute 

to that material.” (Barlaz, Tr. 2237). 

1939. When a researcher buries a product in a landfill, you cannot measure methane and 

CO2 emissions. (Barlaz, Tr. 2237). 

1940. In in situ studies, “[a]ll you’re going to do is put it in the landfill and then at some 

point later go dig it up and say it’s either here or it’s not here or it’s here and it lost 

this much weight.” (Barlaz, Tr. 2237). 

1941. There are many problems with the in situ landfill testing, including loss of product 

samples which frequently occurs. (Barlaz, Tr. 2237). 

1942. Also, during in-situ studies, the researcher cannot determine if weight loss was 

specifically attributed to biodegradation. (Barlaz, Tr. 2238). 

1943. Landfill in situ studies therefore allow only for qualitative information about a test 

sample. (Barlaz, Tr. 2238). 

1944. Practical difficulties also limit the availability of landfill in situ testing. (Barlaz, Tr. 

2238). 

1945. Those difficulties include finding cooperative landfills that will work with researchers 

to maintain access to landfill sites and samples, and agree not to deposit additional 

waste on top of the test area. (Barlaz, Tr. 2238). 
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1946. According to Dr. Barlaz, “to suggest that [in situ landfill studies] are what we have to 

do to make – to prove a material is biodegradable to me is, number one, technically 

it’s not sound because you can’t measure methane and CO2. And even if ... 

technically it were sound, you’re imposing this hurdle on people that’s completely 

unrealistic.” (Barlaz, Tr. 2238-39). 

1947. There is no set definition for a “lysimeter” as used in biodegradation testing. (Barlaz, 

Tr. 2239). 

1948. Dr. Barlaz has not performed lysimeter studies in his laboratory, although he had 

participated in several lysimeter projects at other sites. (Barlaz, Tr. 2240). 

1949. Dr. Barlaz disagreed with Dr. Tolaymat’s position that lysimeter studies should be 

used to test for biodegradation, and Dr. Barlaz “was surprised” that Dr. Tolaymat had 

used data on settlement and leachate quality to obtain data on the biodegradability of 

a specific material, which is not scientifically supported. (Barlaz, Tr. 2240-41). 

1950. Dr. Barlaz found Dr. Tolaymat’s suggested use of lysimeter studies to be unscientific 

because it would be extremely difficult to gather useable, representative 

biodegradability data from a large lysimeter design. (Barlaz, Tr. 2241-42). 

1951. Assuming it was even possible to get data showing anaerobic biodegradability from a 

lysimeter test, Dr. Barlaz explained that you would then need to test for multiple 

years to gather suitable data on a slowly degrading substrate. (Barlaz, Tr. 2242-43). 

D. Dr. Barlaz Testified that Complaint Counsel’s Reliance on 

Carbon-14 Testing Is Unsupported 

1952. Dr. Barlaz is familiar with carbon-14 testing for biodegradable substances. (Barlaz, 

Tr. 2243-44). 

1953. Dr. Barlaz explained that it is important to recognize that the carbon-14 reactor test 

has the “exact same premise or exact same conceptual experimental design as a 

reactor test where you’re using regular carbon that’s not radiolabeled.” (Barlaz, Tr. 

2244). 

1954. The advantage of using carbon-14 testing goes only to sensitivity of testing where the 

laboratory is measuring minute amounts of biodegradation. (Barlaz, Tr. 2244). 

1955. Dr. Barlaz testified that, where the laboratory is measuring substantial amounts of 

methane and carbon dioxide, the carbon-14 test does not “buy[] you anything.” 

(Barlaz, Tr. 2244). 
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1956. Dr. Barlaz also explained that where you have a polymer that consists of more than 

one compound, you have to carbon-14 label the molecule precisely where you want 

it, and that is not easy to accomplish. (Barlaz, Tr. 2244-45). 

1957. Dr. Barlaz has had people ask for carbon-14 testing, and he has not been able to direct 

them to a laboratory that can properly synthesize a C-14 labeled compound for 

plastics biodegradation testing. (Barlaz, Tr. 2245). 

1958. Dr. Barlaz would be surprised if any expert had performed C-14 testing on the plastic 

products at issue in this case, because he testified that it would be hard to find 

someone who could make the properly radiolabeled plastic for testing. (Barlaz, Tr. 

2245-46). 

1959. In the mid-1990s, Dr. Barlaz purchased radiolabeled products from a company, 

American Radiolabeled Chemicals, which company Complaint Counsel suggests was 

capable of providing radiolabeled polymers for testing. (Barlaz, Tr. 2321-22). 

1960. American Radiolabeled Chemicals incorrectly characterized the C-14 that they sold 

Dr. Barlaz. (Barlaz, Tr. 2322). 

1961. Dr. Barlaz discovered after months of testing that the radiolabeled product supplied 

by American Radiolabeled Chemicals was incorrect by an order of magnitude ten 

different from what they told Dr. Barlaz that they had sold him. (Barlaz, Tr. 2322). 

1962. Dr. Barlaz had used the C-14 radiolabeled product in a test of cellulose polymers—

not plastics. (Barlaz, Tr. 2321-22). 

1963. Dr. Barlaz testified that C-14 radiolabeled testing is not generally accepted in the 

relevant scientific community as necessary evidence to show biodegradation of 

materials. (Barlaz, Tr. 2246). 

E. Dr. Barlaz Testified that Gas Evolution Data from ECM 

Biodegradation Testing Proves that Plastic Containing the ECM 

additive are Biodegradable 

1964. In a gas evolution laboratory-scale reactor test, it is broadly accepted by the scientific 

community that biodegradation can be proven with data showing that the volume of 

methane produced in the test vessel is greater than the volume of gas produced in the 

inoculum. (Barlaz, Tr. 2246). 

1965. Dr. Barlaz reviewed many of the gas evolution studies involving ECM amended 

plastics. (Barlaz, Tr. 2247). 
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1966. Dr. Barlaz was “surprised” that Drs. McCarthy and Tolaymat were dismissive of gas 

evolution testing without having examined the data. (Barlaz, Tr. 2247). 

1967. Dr. Barlaz examined the raw data produced by certain laboratories, particularly the 

data concerning methane generation from the test substrate and methane generation 

from the inoculum that would be the background methane. (Barlaz, Tr. 2247-48). 

1968. For those tests where Dr. Barlaz had triplicate data (e.g., raw data), he performed 

statistical analysis, including T-tests, to determine whether there were statistically 

significant differences between the methane generation in the reactor with the test 

substrate and the methane attributable to the inoculum alone. (Barlaz, Tr. 2248). 

1969. “In many cases,” Dr. Barlaz determined from the data itself that the results were 

statistically significant, and that the data suggested that there was anaerobic 

biodegradability of the test plastic. (Barlaz, Tr. 2248). 

1970. For other studies where triplicate data was not available, Dr. Barlaz examined the 

ratios of methane generation in the test material plus inoculum to methane generation 

from the inoculum only. (Barlaz, Tr. 2248). 

1971. Dr. Barlaz concluded for those studies that ratios varied, but the ratios were generally 

significant even at the lower end. (Barlaz, Tr. 2248-49). 

1972. From those ratios, Dr. Barlaz determined that the methane generation in the test 

vessels could be attributable to the test substrate, which suggests that the substrate 

was undergoing anaerobic biodegradation and conversion to methane. (Barlaz, Tr. 

2249, 2260-62). 

1973. Dr. Barlaz prepared a spreadsheet of his statistical calculations. (Barlaz, Tr. 2250; 

RX 472). 

1974. Dr. Barlaz had also updated his spreadsheet to include additional calculations based 

on the data. (Barlaz, Tr. 2251; RX 968). 

1975. To address the question of whether only the ECM additive had biodegraded, Dr. 

Barlaz estimated the amount of methane that could theoretically be produced by the 

ECM additive alone. (Barlaz, Tr. 2251-53). 

1976. Dr. Barlaz made certain conservative assumptions about the ECM additive when he 

calculated the amount of potential methane. (Barlaz, Tr. 2252-53). 

1977. Dr. Barlaz’s conservative calculation was that one gram of ECM additive would 

produce 933 mL of methane gas. (Barlaz, Tr. 2253). 
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1978. Based on that calculation of 933 mL, Dr. Barlaz looked at the methane yields in the 

test vessels during biodegradation testing, and determined if the amount of 

biodegradation exceeded the amount that could potentially be sourced from the 

additive. (Barlaz, Tr. 2253-54). 

1979. Dr. Barlaz’s calculation of the potential methane yield of the ECM additive is likely 

conservative because of the assumptions he made. (Barlaz, Tr. 2254). 

1980. Dr. Barlaz assumed the additive was 50% carbon. (Barlaz, Tr. 2254). 

1981. Polyethylene, by contrast, is almost 90% carbon. (Barlaz, Tr. 2254). 

1982. Dr. Barlaz also calculated the methane yield of the ECM additive based on the 

formula for the ECM additive that Dr. McCarthy used in his expert report at page 24, 

footnote 17 of his report. (Barlaz, Tr. 2254-55; CCX 891 at 24 n.17). 

1983. Based on Dr. McCarthy’s description of the ECM additive allegedly based on reverse 

engineering, Dr. Barlaz calculated a methane yield for the ECM additive of 838 mL 

per gram. (Barlaz, Tr. 2255; RX 968). 

1984. Thus, using Dr. McCarthy’s assumptions, the data produced in the gas evolution tests 

suggests that even more of the substrate plastic (not the additive) biodegraded 

because the ECM additive would have had a lower potential methane yield. (Barlaz, 

Tr. 2255-56). 

1985. Using the Minigrips NE Lab study as an example (RX 838), Dr. Barlaz explained the 

arithmetic summarized in his spreadsheet. (Barlaz, Tr. 2256-57; RX 968). 

1986. Dr. Barlaz calculates the weight of the ECM additive (in grams) by multiplying the 

percentage of the ECM additive load rating (in the Minigrips test, 1.5%) by the 

starting weight of the entire test plastic. (Barlaz, Tr. 2256-57). 

1987. Because Dr. Barlaz has calculated the amount of total methane potential from one 

gram of ECM additive, he can then determine the total amount of methane possible in 

the ECM additive in each specific test by multiplying the actual weight of the ECM 

additive by the conservative 933 mL calculation (or 838 mL if using Dr. McCarthy’s 

assumptions). (Barlaz, Tr. 2256-58). 

1988. Dr. Barlaz also calculated the net methane for each test vessel, which he did by 

subtracting the mean triplicate methane data from the inoculum blanks from the test 

vessels. (Barlaz, Tr. 2257-58; RX 968 (Summary sheet)). 

1989. For those studies where Dr. Barlaz had raw data, he calculated T-tests. (Barlaz, Tr. 

2257). 
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1990. The T-statistic is the most common statistical test after a calculation of the average. 

(Barlaz, Tr. 2259). 

1991. Dr. Barlaz also calculated standard deviations for tests where he had triplicate data, 

however the T-test is superior in that it also takes into consideration the elements of 

standard deviation. (Barlaz, Tr. 2264). 

1992. Dr. Barlaz looked for a 95% certainty in the statistics that he ran, which would mean 

that the researchers are 95% “certain that you got the right answer.” (Barlaz, Tr. 

2260). 

1993. Dr. Barlaz’s t-statistics were generally well below the .05 that indicates statistical 

significance at the 95% level. (Barlaz, Tr. 2257). 

1994. Dr. Barlaz’s mathematical process is explained in his testimony. (Barlaz, Tr. 2257-

59). 

1995. Dr. Barlaz explained that where the methane produced from the test vessel is not 

attributable to the inoculum, and not attributable to the ECM additive, then the 

biodegradation must come from the plastic substrate itself. (Barlaz, Tr. 2258). 

1996. Dr. Barlaz’s calculations are also conservative because “it’s not proven” that the 

ECM additive would completely biodegrade on its own while locked within the 

plastic without also having the plastic biodegrade along with the additive. (Barlaz, 

Tr. 2258). 

1997. Dr. Barlaz also analyzed the ratios of methane to carbon dioxide in the lab tests. 

(Barlaz, Tr. 2261-62). 

1998. A ratio of methane to carbon dioxide that is greater than 1:1 respectively is a good 

indication that the anaerobic environment was behaving properly. (Barlaz, Tr. 2262-

63). 

1999. Gas evolution testing also does not account for carbon that may have been cleaved 

from the substrate but converted to cell mass instead of gas. (Barlaz, Tr. 2263-64). 

2000. Therefore, the biodegradation numbers calculated by the laboratories based on gas 

data alone are a lower limit of the carbon conversion that was actually realized. 

(Barlaz, Tr. 2263-64). 

2001. Based on his statistical analyses and the test data he reviewed concerning ECM 

amended plastics, Dr. Barlaz testified that competent and reliable scientific evidence 

exists to show that plastics manufactured with the ECM additive are anaerobically 

biodegradable. (Barlaz, Tr. 2264-65). 
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2002. Dr. Barlaz testified that “there are certainly many tests where there’s good scientific 

evidence that the material – that the material underwent anaerobic [biodegradation].” 

(Barlaz, Tr. 2265). 

2003. Dr. Barlaz also performs commercial BMP testing in his lab for interested companies. 

(Barlaz, Tr. 2265). 

2004. Dr. Barlaz has tested certain plastic articles that contained the ECM additive. (Barlaz, 

Tr. 2265). 

2005. Dr. Barlaz’s experience with BMP testing is primarily with cellulosic material, which 

means that the majority of his testing has involved municipal solid waste testing, and 

cellulose is a major biodegradable component of same. (Barlaz, Tr. 2266). 

2006. Dr. Barlaz’s “BMP” studies have been conducted mostly up to 60 days in duration. 

(Barlaz, Tr. 2267). 

2007. Dr. Barlaz testified that, with respect to slowly degrading materials, the BMP test that 

Dr. Barlaz runs is likely not representative of the total biodegradation expected from 

the material, and that it is quite possible that the material would have continued to 

biodegrade after Dr. Barlaz terminated his test. (Barlaz, Tr. 2267-68). 

2008. If the experimental goal of the test is to capture the maximum methane yield of a test 

substrate, then Dr. Barlaz testified that a 60-day test is too short to accomplish that 

objective. (Barlaz, Tr. 2267). 

2009. Document RX 952 represents an example BMP test that Dr. Barlaz performed on an 

ECM amended plastic. (Barlaz, Tr. 2269-70; RX 952). 

F. Dr. Barlaz Testified that the Plateau and Priming Effects are Not 

Bases to Reject ECM Testing 

1. The Plateau Effect 

2010. Dr. Barlaz has also reviewed tests in this case that were inconclusive with respect to 

the amount of biodegradation observed in the test environment. (Barlaz, Tr. 2272). 

2011. Inconclusive tests can be the result of an inoculum that is not viable. (Barlaz, Tr. 

2272-73). 

2012. For slowly degrading substances, there is risk that the inoculum may not remain 

viable over time in a closed-system laboratory reactor test. (Barlaz, Tr. 2273-74). 
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2013. The inconclusive test results relevant to this case do not alter Dr. Barlaz’s opinion 

concerning the evidence that shows plastics amended with ECM’s additive were 

shown to biodegrade anaerobically. (Barlaz, Tr. 2274). 

2014. Based on the totality of the scientific evidence, Dr. Barlaz concluded that, while there 

were some tests that did not conclusively show anaerobic biodegradation, “many 

more” did, and, so, “in totality there’s evidence that the material is anaerobically 

biodegrading.” (Barlaz, Tr. 2274). 

2. The Priming Effect 

2015. The scant information in the peer-reviewed literature concerning the “priming effect” 

of a substrate in the test environment has generally been limited to rapidly accessible 

or degrading substrates like glucose. (Sahu, Tr. 1888-89). 

2016. There is no consensus in the literature as to what the priming effect is, and the degree 

to which it could be in action during biodegradation testing of plastics. (Sahu, Tr. 

1889). 

2017. Dr. Barlaz is familiar with Dr. McCarthy’s theory on the “priming effect.” (Barlaz, 

Tr. 2277). 

2018. Dr. Barlaz testified that the priming effect theory is based on unsupported 

assumptions that when the ECM additive is degraded, it stimulates the inoculum and 

results in an increase in background methane. (Barlaz, Tr. 2277-78). 

2019. Dr. Barlaz testified that the priming effect, as described by Complaint Counsel’s 

witnesses, was “speculative,” stating that it was “quite a stretch to dismiss ... data on 

the basis of a priming effect.” (Barlaz, Tr. 2278). 

2020. Dr. Barlaz testified that the “priming effect” theory was first described in the peer 

reviewed literature in reference to aerobic systems only, and then only with readily 

degradable substrates. (Barlaz, Tr. 2278). 

2021. Dr. Barlaz explained that the priming effect theory described by Complaint Counsel’s 

witnesses has not been reported in the peer-reviewed literature with respect to 

anaerobic systems and slowly degradable substrates like the ECM additive. (Barlaz, 

Tr. 2278-79). 

2022. Dr. Barlaz explained that, per Dr. McCarthy’s report, the ECM additive was mostly 

polycaprolactone (PCL), and in Dr. Barlaz’s own research, the amount of degradation 

solely from PCL was not that significant to stimulate background methane. (Barlaz, 

Tr. 2279-80). 
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2023. Dr. Barlaz explained that, in the absence of any peer reviewed literature or 

evidentiary support, which Complaint Counsel’s experts did not provide, the priming 

effect theory was “quite speculative as a way to shoot down a test.” (Barlaz, Tr. 

2280). 

2024. Comparing a potential priming effect from a readily degradable substrate in an 

aerobic environment to a slowly degradable substrate in an anaerobic environment is 

not an appropriate comparison scientifically. (Barlaz, Tr. 2280-81). 

2025. Dr. Barlaz also explained that the amount of biodegradation observed in the ECM 

tests is much higher than any reasonable interpretation of a priming effect theory and, 

so, the so-called “priming effect” would need to be massive to swallow the test 

results. (Barlaz, Tr. 2280). 

2026. According to Dr. Barlaz, given the amount of biodegradation observed, “if someone 

is going to use [the priming effect] to throw out data, I’d like to see something more 

than this, what to me is [a] theoretical possibility without supporting data.” (Barlaz, 

Tr. 2280). 

2027. Dr. Sahu also explained in his testimony that the theory of a “priming effect” 

presented by Complaint Counsel’s witnesses was unsupported. (Sahu, Tr. 1936-37). 

2028. Dr. Sahu testified that the amount of methane and carbon dioxide gas emitted from 

the test vessels far exceeded that which could have been sourced by the inoculum and 

the ECM additive. (Sahu, Tr. 1936-37). 

2029. That amount of gas has to come from the test plastic. (Sahu, Tr. 1936). 

2030. Furthermore, as a way to check against the priming effect, Dr. McCarthy suggested 

that the laboratories test the ECM additive by itself to determine how much, if any, 

methane would be sourced from the additive alone. (McCarthy, Tr. 418, 449). 

2031. In one of his BMP tests, Dr. Barlaz actually did test the ECM additive by itself. 

(CCX 951; Barlaz, Tr. 2312-14). 

2032. In that test (CCX 951), Dr. Barlaz reported that the amount of methane produced 

from the ECM additive alone, under BMP testing conditions that favor 

biodegradation, was 151.2 mL CH4/g. (CCX 951 at 2). 

2033. Thus, the additive itself did not produce a priming effect equivalent to that which 

Complaint Counsel ascribes to other positive ECM tests. (CCX 951 at 2). 

2034. Moreover, the additive produced methane within the range that Dr. Barlaz had 

calculated based on his Buswell equation memorialized in RX 968. (RX 472; RX 

968). 
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2035. Based on Dr. McCarthy’s own suggestion, therefore, the data in CCX 951 contradicts 

the priming effect theory. (CCX 951 at 2). 

2036. Dr. McCarthy himself relied on gas evolution testing (not carbon-14 radiolabeled 

testing) to demonstrate that his polymer blends were biodegradable. (Sahu, Tr. 1893-

94; RX 756 at 8-12). 

2037. In his own biodegradation testing, Dr. McCarthy did not account for, or even 

mention, any biodegradation that might result from the theoretical priming effect. 

(RX 756). 

XV. DR. RYAN BURNETTE TESTIFIED TO THE KINDS, NATURE, AND 

FUNCTIONS OF MICROBES THAT BIODEGRADE PLASTICS 

2038. Dr. Ryan Burnette testified based on his extensive experience as a microbiologist and 

biochemist. (Burnette, Tr. 2360-71). 

2039. Dr. Burnette researched the peer reviewed literature concerning the microbes 

associated with plastics biodegradation. (Burnette, Tr. 2372). 

2040. Dr. Burnette testified that landfills have a wide variety of microorganisms capable of 

participating in biodegradation processes. (Burnette, Tr. 2372-73). 

2041. Dr. Burnette also testified that, while the ASTM D5511 test environment features 

many conditions similar to those in MSW landfills, the test is also not necessarily 

representative of all conditions in landfills and, so, the D5511 test environment is not 

necessarily “optimal” to show the full range of biodegradation that might occur in 

landfills. (Burnette, Tr. 2373). 

2042. Dr. Burnette testified that the D5511 or similar laboratory reactor testing is competent 

and reliable scientific evidence to assess biodegradability of materials in landfills. 

(Burnette, Tr. 2373). 

2043. However, Dr. Burnette also explained that it would be difficult to maintain adequate 

biological life in a closed-system laboratory environment for sustained periods of 

time and, so, the test environments have a finite life span that may not be adequate to 

assess the full spectrum of biodegradation possible. (Burnette, Tr. 2374-75). 

2044. Biodegradation involves microorganisms acting on substrates to break down same. 

(Burnette, Tr. 2376-77). 

2045. Bacteria are the most proliferative, abundant form of life known. (Burnette, Tr. 

2377). 
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2046. Bacteria can be prokaryotes or eukaryotes. (Burnette, Tr. 2377). 

2047. Bacteria are very small, single-celled organisms that primarily live in colonies. 

(Burnette, Tr. 2378). 

2048. There are bacteria that are specifically anaerobic, called obligate anaerobes, which 

can only proliferate in an anaerobic environment. (Burnette, Tr. 2378-79). 

2049. There is a broad class of bacteria, called facultative anaerobes, which possess the 

tools to live, proliferate, reproduce, and feed in both oxygen and non-oxygen 

containing environments. (Burnette, Tr. 2379). 

2050. The types of microorganisms relevant to biodegradation can be facultative anaerobes, 

obligate anaerobes, methanogens, and archaea bacteria. (Burnette, Tr. 2379-80). 

2051. Archaea bacteria are within a subclass of bacteria that contain many types of 

anaerobic organisms. (Burnette, Tr. 2380). 

2052. Enzymes are proteins by definition. (Burnette, Tr. 2380). 

2053. Enzymes catalyze reactions or expedite reactions that may move slowly without the 

enzyme. (Burnette, Tr. 2380). 

2054. Enzymes have active sites which structurally favor the substrate in a manner such that 

the reaction can be facilitated. (Burnette, Tr. 2381). 

2055. Enzymes in landfills come primarily from microorganisms, bacteria and fungi. 

(Burnette, Tr. 2382). 

2056. Enzymes in nature are not made without the presence of an organism to make them. 

(Burnette, Tr. 2382). 

2057. In an MSW landfill, with respect to the degradation of food sources, the goal of 

enzymatic production is to obtain carbon for microbial metabolism. (Burnette, Tr. 

2383-84). 

2058. There are bacteria that secrete certain chemicals, e.g., polysaccharide in nature, acidic 

or basic, that would result in chemical degradation of food sources. (Burnette, Tr. 

2384). 

2059. Methane production is clear evidence that MSW landfills are biologically active 

because methane is the direct result of anaerobic metabolism. (Burnette, Tr. 2385). 

2060. Microbial succession is the lifecycle of microorganisms. (Burnette, Tr. 2385). 
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2061. In the environment, it would be rare to find a singular species of bacteria. (Burnette, 

Tr. 2385). 

2062. In the natural environment multiple species of bacteria coexist and each has a discrete 

function in the overall cycle of life. (Burnette, Tr. 2385). 

2063. Microbial succession involves the lifecycle of a population of bacteria from initiation 

through proliferation until death. (Burnette, Tr. 2385). 

2064. Dr. Burnette testified to microbial succession in landfills from the initial stages of 

aerobic metabolism into acetogenesis, and eventually methane production. (Burnette, 

Tr. 1286-87). 

2065. Dr. Burnette testified that, with respect to microbial composition, it would be 

unreasonable to expect or identify a “one-size-fits-all” description of an MSW landfill 

because the diversity of potential environments presented in landfills is vast with too 

many variables, which, in turn, leads to proliferation of many different types of 

microorganisms. (Burnette, Tr. 2388). 

2066. Dr. Burnette explained that it would be scientifically impractical (if not impossible) to 

design a perfect closed-system test that would be representative of all the potential 

microenvironments in an MSW landfill. (Burnette, Tr. 2388). 

2067. In a laboratory closed-system reactor, the test article is not exposed to all of the 

conditions which it may be exposed to in an MSW landfill. (Burnette, Tr. 2389). 

2068. The closed-system test is also subject to design issues that impart certain limitations. 

(Burnette, Tr. 2389). 

2069. Limitations of the closed-system test environment are significant because, in the 

natural environment where those limitations are removed, the biodegradation of test 

substrates could be even greater. (Burnette, Tr. 2389-90). 

2070. Researchers have identified many specific microorganisms that populate MSW 

landfills. (Burnette, Tr. 2390). 

2071. Dr. Burnette summarized in his expert report the peer reviewed literature wherein 

scientists have used DNA sequencing to identify a non-exclusive list of many species 

existing in landfills which are capable of degrading plastics. (Burnette, Tr. 2390; RX 

854 at 10). 

2072. Landfills contain species within the phyla Proteobacteria, Firmicutes, and 

Thermotagae which are large families that contain many forms of individual bacteria. 

(Burnette, Tr. 2391-92). 
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2073. There are also fungi present in landfills that have been identified in the peer reviewed 

literature and are responsible for biodegradation. (Burnette, Tr. 2392, 2394). 

2074. The diversity of species in landfills is substantial, and it is likely that many of the 

bacterial species present in landfills are also present in D5511 test environments, and 

similarly responsible for biodegradation observed therein. (Burnette, Tr. 2392). 

2075. The process of biodegradation and bacterial metabolism can take several paths to 

access carbon in substrates, including, e.g., hydrolysis reactions, oxidative reactions, 

and fermentation. (Burnette, Tr. 2396-99). 

2076. From a microbiological standpoint, the terms “priming effect” and “plateau effect” 

have very different meanings from the way in which Complaint Counsel’s experts 

have used them in this case. (Burnette, Tr. 2399-2400). 

2077. Dr. Burnette has not seen any evidence in the peer reviewed literature or in his 

experience as a microbiologist that suggests the priming effect that Dr. McCarthy 

posited could be responsible for the biodegradation observed in ECM’s testing. 

(Burnette, Tr. 2400). 

2078. In terms of a “plateau” effect in the laboratory environment, as that phrase is used in 

this case, Dr. Burnette testified that the plateau is very likely caused by the test 

conditions and not the biodegradability of the test plastic. (Burnette, Tr. 2401-02). 

2079. No life is designed to live in a closed system for a sustained period of time. (Burnette, 

Tr. 2401-02). 

2080. In the closed-system laboratory there is no way to release or expel the waste products 

created by the bacterial metabolism. (Burnette, Tr. 2402). 

2081. If in a closed-system laboratory reactor the test material is slowly degrading, then you 

would not be expected to see prolonged biodegradation over time because the 

microorganisms that would act upon the substrate simply die. (Burnette, Tr. 2403). 

2082. Feedback inhibition is a common mechanism by which the product of a biochemical 

reaction itself will loop back and negatively impact further production of the product, 

like an accumulation event that prevents the reaction from going forward. (Burnette, 

Tr. 2403-04; RX 854 at 14 (figure 5)). 

2083. The buildup of inhibitory byproducts can begin to occupy binding sites of certain 

other enzymes. (Burnette, Tr. 2404-05). 

2084. When that happens, the byproducts of the microbiological metabolic functions will 

compete adversely with the substrate for enzymatic binding sites. (Burnette, Tr. 

2405). 
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2085. Virtually all microorganisms are susceptible to feedback inhibition effects. (Burnette, 

Tr. 2405). 

2086. Although the mechanism of feedback inhibition is identical in the natural landfill 

environment, the difference is that, in a closed system, the inhibitory byproducts 

cannot be expelled or cleared from the ecosystem, while in a landfill setting the 

byproducts are dispersed or flushed in an open system. (Burnette, Tr. 2405-06). 

2087. A biofilm is the formation of microbial colonies in a somewhat concerted manner 

which develop into films. (Burnette, Tr. 2406). 

2088. Bacteria can adhere to plastics, in part, by secreting polysaccharides which promote 

bonding to the food source. (Burnette, Tr. 2407-08). 

2089. The process of adhering to potential food substrates has been described as “docking 

and locking.” (Burnette, Tr. 2408). 

2090. The surface area of a plastic has a substantial influence on the ability of a biofilm to 

form and adhere. (Burnette, Tr. 2409). 

2091. Biofilms can contain hundreds to thousands of bacterial species. (Burnette, Tr. 2410). 

2092. Closed system laboratories may restrict the types of conditions that allow certain 

bacteria to thrive and, thus, the test environment may unintentionally limit the 

biodegradation that can be observed. (Burnette, Tr. 2412-13). 

2093. Dr. Burnette testified that biodegradation seen in a closed laboratory system is 

expected to be less overall than biodegradation in an open, natural system where the 

diversity of bacteria and conditions are more substantial. (Burnette, Tr. 2412-13). 

2094. Enzymes can weaken or break carbon-carbon bonds in plastic polymers (and other 

long-chain polymers) by lowering the energy required to break the bonds. (Burnette, 

Tr. 2414). 

2095. For instance, the increase in free chlorine ions in solution during the Environ BioPVC 

test was a clear indication that the carbon-carbon bonds were either broken or the 

bond breakage was imminent. (Burnette, Tr. 2415-16). 

2096. Dr. Burnette diagrammed his analysis of the PVC degradation extemporaneously at 

his deposition. (Burnette, Tr. 2415-16; CCX 1081). 

2097. When chlorine atoms are present in the solution of the BioPVC test, it indicates that 

the HCl group was cleaved from the polymer through a nucleophilic attack on the 

PVC molecule. (Burnette, Tr. 1415-17). 
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2098. The resulting PVC molecule is substantially weakened in that area, and the carboncarbon bonds will thus break because the remaining carbon-carbon bond is subject to 

a hydrolysis reaction that will, in fact, cause bond breakage. (Burnette, Tr. 2417; 

CCX 1081). 

2099. The fact that PVC becomes unstable and degraded after losing the HCl group is a 

textbook analysis of a nucleophilic attack; it is documented in the peer-reviewed 

literature, and it is “a fundamental of biochemistry.” (Burnette, Tr. 2418). 

2100. “Nucleophilic attack” means that the enzyme is looking for a positively charged 

substance to attack. (Burnette, Tr. 2418). 

2101. Depolymerases are a class of enzymes that reduce large polymers into smaller units. 

(Burnette, Tr. 2418-19). 

2102. Depolymerases are also responsible for biodegradation of plastic polymers, and they 

are ubiquitous in the environment. (Burnette, Tr. 2418-21). 

2103. Depolymerases use hydrolysis and nucleophilic attacks to break bonds, and they are 

involved in the reduction and oxidation reactions. (Burnette, Tr. 2419). 

2104. Dr. Burnette’s expert report (RX 854) documented several microorganisms that have 

been identified for their ability to biodegrade plastic polymers. (Burnette, Tr. 2420-

21). 

2105. For example, Rhodococcus rubber uses hydrolases and enzymes called esterases to 

break apart polyethylene polymers into smaller subunits. (Burnette, Tr. 2421). 

2106. Oxidation reactions are simply reactions that involve the addition of electrons. 

(Burnette, Tr. 2421). 

2107. An oxidative reaction can occur in anaerobic systems. (Burnette, Tr. 2421-22). 

2108. Oxidative reactions can play a role in anaerobic biodegradation of polymers. 

(Burnette, Tr. 2422). 

2109. Anaerobic and aerobic metabolisms in microorganisms are different concepts, but 

they share many key similarities, including certain Bs of action used to achieve the 

breakdown of substrates. (Burnette, Tr. 2423-25). 

2110. For example, the use of pyruvate dehydrogenase is a key ingredient and factor in both 

aerobic and anaerobic metabolism. (Burnette, Tr. 2424-25). 

2111. Dr. Burnette explained that one documented pathway to polyethylene biodegradation 

includes a common mechanism applicable to both aerobic and anaerobic systems, 
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including the cofactor NAD, and the oxidative reactions that occur in both 

environments. (Burnette, Tr. 2426). 

2112. The mechanisms of aerobic biodegradation are therefore useful to interpreting 

anaerobic biodegradation of polymers like polyethylene. (Burnette, Tr. 2426). 

2113. Dr. Burnette identified and testified to other mechanisms of enzymatic degradation of 

plastic polymers, including the degradation of polyethylene terephthalate, a more 

difficult to digest polymer, using the cutinase enzyme. (Burnette, Tr. 2428). 

2114. Hydrolysis reactions are not limited to environments with high moisture contents. 

(Burnette, Tr. 2429). 

2115. Digestion of certain polymer chains may require just a few molecules of water. 

(Burnette, Tr. 2429). 

2116. Dr. Burnette testified that mesophilic and thermophilic bacteria function at different 

temperatures and pace, but they use common and universal mechanisms of action to 

gain access to food sources. (Burnette, Tr. 2430-31). 

2117. Dr. Burnette explained that many bacteria identified in the peer reviewed literature as 

responsible for biodegrading plastics fall within the mesophilic range. (Burnette, Tr. 

2432). 

2118. Therefore, because bacteria capable of degrading plastics are mesophilic, test 

conditions (like the D5511) that promote only thermophilic bacteria may not provide 

a truly “optimal” environment for assessing total biodegradability. (Burnette, Tr. 

2432-33). 

2119. Certain mesophiles will die at higher temperatures, or become ineffective. (Burnette, 

Tr. 2432). 

2120. Dr. Burnette testified that the ECM additive likely promotes biodegradation in two 

ways: first by serving as an attractant for microbial growth on and within plastics; 

and second, by weakening or perturbing the carbon-carbon bonds through weaknesses 

in the chain or the addition of more weak points in the form of the additive. 

(Burnette, Tr. 2435-37). 

2121. Dr. Burnette testified that the D5511 test is a good measure of biodegradability in an 

MSW landfill because the biodegradation observed in the D5511 test has occurred 

despite the limitations of a closed-system, ecologically limited test environment. 

(Burnette, Tr. 2438-39). 
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2122. In the open landfill environment, while biodegradation may be at varying rates, the 

total biodegradation should be expected to increase or, at least, continue onward 

absent the limitations of a closed-system test. (Burnette, Tr. 2437-40). 

2123. The D5511 test represents still a subset of the conditions found in MSW landfills. 

(Burnette, Tr. 2439-40). 

2124. Dr. Burnette testified that “negative” tests are not the same thing as “inconclusive” 

tests, and a test is not truly “negative” until all of the variables have been explored 

and you still have replicability of results. (Burnette, Tr. 2442). 

2125. Dr. Burnette considers the likelihood of cell death in a closed-system laboratory test 

to be probable without refreshing the system with new nutrients or expelling the 

waste. (Burnette, Tr. 2442-43). 

2126. The untimely death of the microorganisms in the closed-system laboratory test makes 

for an inconclusive test with respect to biodegradation testing, and not a negative 

outcome adverse to the test article. (Burnette, Tr. 2443). 

2127. Dr. Burnette also testified that a direct comparison of the rate or extent of 

biodegradation in cellulose to the rate or extent of biodegradation in the test plastic is 

not appropriate scientifically because: (a) cellulose is degraded by an entirely 

different, and very ubiquitous enzyme called cellulace; and (b) cellulose is chosen as 

a positive control because it is rapidly degradable, while plastics with the ECM 

additive are comparatively slow degrading products. (Burnette, Tr. 2444-45). 

2128. In context with a discussion about microbiological pathways involved in polymer 

biodegradation, the persistent set of positive ECM test results reveals that the additive 

is, in fact, enhancing the biodegradation of the plastic itself. (Burnette, Tr. 2446). 

XVI. TESTING PROVES THAT PLASTIC CONTAINING THE ECM ADDITIVE IS 

BIODEGRADABLE 

2129. Numerous gas evolution tests have shown that plastics manufactured with ECM’s 

additive, which otherwise do not biodegrade, have biodegraded to a degree that is 

substantially more than biodegradation that could have been sourced solely by the 

ECM additive. (Barlaz, Tr. 2175). 

A. Aerobic Testing 
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2130. Dr. Barlaz testified that a portion of the “biodegradation” in MSW landfills occurs 

through aerobic processes. (Barlaz, Tr. 2214-15). 

2131. Complaint Counsel’s experts Drs. Tolaymat and McCarthy testified that conventional 

plastics such as polyethylene are otherwise not biodegradable without the ECM 

additive. (Tolaymat, Tr. 245; McCarthy, Tr. 414). 

2132. Dr. Sahu explained that both aerobic and anaerobic studies are useful when 

evaluating whether the ECM additive renders conventional plastics biodegradable. 

(Sahu, Tr. 1917-18). 

1. RX 465, 2009 SSCCP Aerobic Test 

2133. In 2009, the Stazione Sperimental Carta, Cartoni e Paste per Carta (SSCCP), or Pulp 

and Paper Experimental Station (an agency of the Chamber of Commerce in Milan), 

conducted an aerobic composting test of an ECM Plastic. (RX 465) 

2134. The 2009 SSCCP test was performed under ISO 14855, a standard titled 

“Determination of the ultimate aerobic biodegradability of plastic materials under 

controlled composing conditions—Method by analysis of evolved carbon dioxide.” 

(RX 827) 

2135. ISO 14855 describes a “solid-phase respirometric test system based on mature 

compost...” (RX 827 at v). 

2136. The method is “designed to simulate typical aerobic composting conditions for the 

organic fraction of solid mixed municipal waste.” (RX 827 at 1). 

2137. The test assesses biodegradation by measure of carbon dioxide emitted, adjusted for 

the amount of carbon dioxide produced in the “blank” vessels. (RX 827 at 9). 

2138. RX 465 involved a test PVC sample, a sample PET, and a sample “orange film.” 

(RX 465 at 114990). 

2139. Biodegradation of the test sample under aerobic conditions was recorded, including a 

substantial increase in biodegradation beginning, generally, after the twentieth day of 

the 90-day compost test. (RX 465 at 114990). 

2140. The average biodegradation among the triplicate data recorded for the PVC sample 

over the 90 day test period was more than 50%. (RX 465 at 114989). 

2141. The average biodegradation among the triplicate data recorded for the orange film 

sample was 4.8%. (RX 465 at 114989). 

2142. The average biodegradation among the triplicate data recorded for PET sample was 

4.95%. (RX 465 at 114989). 
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2143. The SSCCP test marked as RX 465 involved an ECM additive at a 1% load rating. 

(CCX 202 at 1). 

2144. Dr. Tolaymat testified that PVC, without the ECM additive, is not biodegradable 

under either aerobic or anaerobic conditions. (Tolaymat, Tr. 288). 

2. RX 467, 2012 SSCCP Aerobic Test 

2145. In 2012, the Stazione Sperimental Carta, Cartoni e Paste per Carta (SSCCP), or Pulp 

and Paper Experimental Station (an agency of the Chamber of Commerce in Milan), 

conducted another aerobic composting test of an ECM Plastic under ISO 14855 (RX 

827), on behalf of Colplast Srl. (RX 467). 

2146. The test was performed on a sample marked for identification as “BR-2010.” (RX 

467). 

2147. Test results were reported on January 8, 2013. (RX 467). 

2148. The test marked RX 467 revealed average biodegradation among the triplicate data of 

approximately 12% over the 90-day test period. (RX 467 at 112490). 

2149. The SSCCP test marked as RX 467 involved an ECM additive at a 1% load rating. 

(CCX-196 at 2). 

3. RX 468, 2012 SSCCP Aerobic Test

2150. In 2012, the Stazione Sperimental Carta, Cartoni e Paste per Carta (SSCCP), or Pulp 

and Paper Experimental Station (an agency of the Chamber of Commerce in Milan), 

conducted another aerobic composting test of an ECM Plastic under ISO 14855 (RX 

827), on behalf of Colplast Srl. (RX 468). 

2151. The test was performed on a sample marked for identification as “PR-2011.” (RX 

468). 

2152. Test results were reported on August 1, 2013. (RX 468). 

2153. The SSCCP test marked as RX 468 reflected an average biodegradation among the 

triplicate data of approximately 6.9% over the 90-day test period. (RX 268 at 4). 

2154. The SSCCP test marked as RX 468 involved an ECM additive used at 1.1% load 

rating. (CCX 196 at 4). 

4. RX 273, 2010 Ecologia Applicata Aerobic Test
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2155. In November 2010, Ecologia Applicata Srl., a laboratory based in Milano, Italy, 

reported results from an aerobic test of an ECM-amended plastic artifact (a full coffee 

capsule). (RX 273). 

2156. The test marked as RX 273 involved a polypropylene plastic with 1% ECM additive. 

(RX 273). 

2157. The test marked as RX 273 followed the international ISO 14855 standard for aerobic 

compostability testing. (RX 273 at 2; RX 827 (ISO standard)). 

2158. The test marked as RX 273 reported 19.3% biodegradation of the ECM amended 

plastic after 180 days of testing. (RX 273 at 3). 

2159. The test further calculated, based on the data observed, that the ECM-amended plastic 

would be biodegraded to more than 77% after approximately 2 years. (RX 273 at 3). 

2160. In the test marked RX 273, substantial biodegradation did not begin until after 30 

days of aerobic testing. (RX 273 at 3). 

2161. The rate of biodegradation, as measured through carbon dioxide emissions, revealed 

that at the close of testing on day 180, biodegradation was still continuing. (RX 273 

at 3). 

5. RX 276, 2011 Ecologia Applicata Aerobic Test 

2162. In January 2012, Ecologia Applicata Srl., a laboratory based in Milano, Italy, reported 

results from an aerobic test of an ECM-amended plastic artifact (polyamide nylon 

resin with ECM additive). (RX 276). 

2163. The 2011 Ecologia test marked as RX 276 involved an ECM additive at a 1% load 

rating. (CCX-196 at 2). 

2164. The 2011 Ecologia test marked as RX 276 followed the international ISO 14855 

standard for aerobic compostability testing. (RX 276; RX 827 (ISO standard)). 

2165. In the test marked RX 276, substantial biodegradation did not being until after 20 

days of aerobic testing. (RX 276 at 9). 

2166. The 2011 Ecologia test marked as RX 276 was conducted under 62.47% dry solids 

content, or about 38% moisture. (RX 276 at 4). 

2167. The test marked as RX 276 reported 46.67% biodegradation of the ECM amended 

plastic after 180 days of aerobic testing. (RX 276 at 11). 
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2168. The test further calculated, based on the data observed, that the ECM-amended plastic 

would be biodegraded to more than 88% after approximately 900 days (or about 2.5 

years). (RX 276 at 11). 

6. RX 263, 1998 OWS Aerobic Test 

2169. In August 1998, O.W.S. Inc. reported test results from an aerobic test involving a 5% 

ECM film and a 5% Natural Film (load ratings relating to the amount of ECM added 

by weight). (RX 263 at 1). 

2170. The test was stopped at 45 days. (RX 263 at 3). 

2171. The test was labeled by OWS as “OWS PFR-1,” and it was an aerobic biodegradation 

under controlled composing conditions. (RX 263 at 1). 

2172. In the test marked RX 263, the 5% ECM film showed 4.5% biodegradation, based on 

carbon dioxide readings, after 45 days. (RX 263 a 3). 

2173. The 5% ECM Natural Film showed 2.6% biodegradation over the 45 day period. 

(RX 263 at 3). 

2174. In the test marked RX 263, the average biodegradation of all three cellulose reactors 

reached only 61.1% after 45 days of testing. (RX 263 at 25). 

2175. The biodegradation of the cellulose samples plateaued around the sixth day of testing, 

with the three cellulose vessels demonstrating no more than sixty percent 

biodegradation. (RX 263 at 29). 

7. RX 266, 2000 OWS Aerobic Test 

2176. In March 2000, O.W.S. Inc. reported test results from an aerobic test involving 40-

gallon trash bags amended with the ECM additive. (RX 266 at 1). 

2177. The test was stopped at 45 days. (RX 266 at 3). 

2178. OWS labeled the test “PFR-5,” and it was an “aerobic biodegradation under 

controlled composting conditions.” (RX 266 at 1). 

2179. In the test marked RX 266, the 40-gallon trash bag amended with the ECM trash bag 

biodegraded 5.2% in 45 days of testing. (RX 266 at 3). 

B. Anaerobic Testing 

1. Eden Laboratories (“ERL”) Testing Generally 
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2180. Eden Laboratories (“ERL”) is a laboratory in New Mexico, owned and operated by 

Thomas Poth. (Poth, Tr. 1440-41). 

2181. Thomas Poth performs scientific studies alongside Dr. Brian Esau. (Poth, Tr. 1440-

41). 

2182. Dr. Esau has a master’s degree and a Ph.D. in biochemistry from the University of 

Illinois at Champaign-Urbana. (Poth, Tr. 1441). 

2183. Dr. Brian Esau participates in daily operation of the laboratory, and performs testing 

of products. (Poth, Tr. 1441). 

2184. ERL performs D5511 biodegradation testing for clients. (Poth, Tr. 1447-48). 

2185. ERL follows the D5511 protocol, but has made adjustments to that protocol to more 

closely simulate a landfill. (Poth, Tr. 1449-50). 

2186. ERL has increased the solids content in its D5511 test. (Poth, Tr. 1450). 

2187. Other than the adjustment to solids content (or moisture content), ERL does not alter 

the D5511 test protocol in any substantial way. (Poth, Tr. 1450). 

2188. ERL increased the solids content of its test so that its D5511 test would look more 

like a landfill as opposed to a digester. (Poth, Tr. 1450). 

2189. ERL explained to its customers that ERL’s testing is not performed at optimal 

moisture contents and, as a consequence, the performance of test samples in 

biodegradation testing are not going to be optimal. (Poth, Tr. 1451-52). 

2190. ERL explained that the higher solid content involved in ERL D5511 testing would be 

more appropriate because the testing was more indicative of performance in a landfill. 

(Poth, Tr. 1452). 

2191. ERL prepares its test “inoculum” with compost obtained from a local facility. (Poth, 

Tr. 1457-58). 

2192. ERL conditions its inoculum in an incubator to climatize it to temperature and 

promote selection of anaerobic microbes. (Poth, Tr. 1459-60). 

2193. ERL combines its compost with sewage sludge to form the final inoculum. (Poth, Tr. 

1461). 

2194. Sewage sludge, as used by ERL, consists of the solids that come from the digester in 

ERL’s laboratory. (Poth, Tr. 1461). 
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2195. ERL determines the moisture content of its inoculum, and adjusts the liquid added to 

the inoculum before placing it in the incubator, which helps control the specific 

moisture content in the final, test-ready inoculum. (Poth, Tr. 1463). 

2196. ERL reviews and controls for the carbon to nitrogen levels, the ammonia levels, and 

the pH. (Poth, Tr. 1463-64). 

2197. ERL runs all D5511 tests in triplicate, using three separate test vessels for each of the 

three controls in the D5511 standard, the two additional controls that ERL relies on, 

and the test vessels. (Poth, Tr. 1466). 

2198. ERL uses a gas chromatograph to analyze the gas emissions produced during the 

D5511 test. (Poth, Tr. 1468-69). 

2199. ERL calibrates its gas chromatograph monthly and as appropriate. (Poth, Tr. 1469). 

2200. ERL uses a graduated cylinder to record total gas volume and collect gas during the 

D5511 test. (Poth, Tr. 1468). 

2201. ERL does not use Mylar or Kevlar bags for gas collection because ERL previously 

determined that those bags leaked methane, and because the bags made gas transfer 

difficult. (Poth, Tr. 1468). 

2202. ERL calculates the percentage of biodegradation observed in a D5511 test by 

performing the necessary calculations of theoretical gas yields, and comparing those 

to the gas yield of the sample (excluding the gas produced by the inoculum blanks). 

(Poth, Tr. 1469-71). 

2203. ERL’s method of calculating the percentage of biodegradation follows the ASTM 

D5511 standard. (RX 356 at 4). 

2204. ERL has had difficulties in testing certain plastic polymers in the laboratory reactor 

tests. (Poth, Tr. 1472-73). 

2205. For example, with plastic foams, ERL testified that it was difficult to have decent 

surface area contact with the inoculum. (Poth, Tr. 1473). 

2206. ERL testified that the foam products frequently consumed too much space in the test 

vessel. (Poth, Tr. 1473). 

2207. ERL’s testing protocols, which follow the D5511 test, are not suitable for plastics that 

have components inhibitory to microorganisms. (Poth, Tr. 1471). 

2208. ERL does not refresh inoculum during D5511 tests that are run over a long duration. 

(Poth, Tr. 1474). 
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2209. ERL has seen plateaus in the biodegradation in long term tests, which last for a period 

of up to two months before biodegradation in the test system sometimes resumes. 

(Poth, Tr. 1474). 

2210. ERL uses a standard format for reporting data in a D5511 test. (Poth, Tr. 1480-81). 

2211. Dr. Barlaz visited Eden Laboratories in about December 2012 for a meeting. (Barlaz, 

Tr. 2274). 

2212. His visit to ERL predated and was unrelated to his participation as an expert witness 

in this case. (Barlaz, Tr. 2274-75). 

2213. Having reviewed ERL’s biodegradation testing, Dr. Barlaz was comfortable that 

ERL’s testing was strictly under anaerobic conditions and that Eden Labs had the 

appropriate capability to monitor gas volume and composition. (Barlaz, Tr. 2275). 

2214. Dr. Barlaz observed ERL’s test reactors. (Barlaz, Tr. 2275). 

2215. Dr. Barlaz reviewed ERL’s testing process with ERL’s owner, Thomas Poth. (Barlaz, 

Tr. 2275). 

2216. Dr. Barlaz was comfortable that ERL’s biodegradation testing was “legitimate 

anaerobic testing.” (Barlaz, Tr. 2275). 

a. RX 248, Eden Laboratories No. 092511B 

2217. In September 2011, Eden Laboratories reported test data from an anaerobic D5511 

biodegradation test in laboratory reactors. (RX 248). 

2218. ERL performed the test on behalf of FP International, using test samples that were 

provided by FP. (RX 248 at 1). 

2219. The test marked RX 248 followed the ASTM D5511 protocol. (RX 248 at 1). 

2220. The solid content of the test was 48.4%. (RX 248 at 1). 

2221. The study authors recorded gas evolution data on a weekly basis. (RX 248 at 2-4). 

2222. The study authors calculated pH volumes, volatile fatty acids, and ammonium 

nitrogen levels. (RX 248 at 1). 

2223. The test marked RX 248, as with all ERL D5511 tests, included the use of an 

inoculum blank, a negative control (polyethylene), a positive control (cellulose), a 

negative control consisting of an untreated plastic, and two test samples, all of which 

were run in triplicate. (RX 248; Poth, Tr. 1466-67). 
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2224. The test marked RX 248 included two “test” plastic samples both amended with the 

ECM additive at 1% by weight. (RX 248 at 1-2). 

2225. The two test samples, marked “ERL #223” and “ERL #224” in RX 248, were 

polyethylene “airbags.” (Blood, Dep. at 166-169) 

2226. The test marked RX 248 involved a negative control that was an “airbag control,” a 

plastic that was not amended with the ECM additive. (RX 248). 

2227. The test marked RX 248 revealed biodegradation of the two ECM amended plastics 

in the amount of 11.5% for sample “223” and 15.2% for sample “224” after 120 days 

of anaerobic testing. (RX 248 at 5). 

2228. In the test marked RX 248, the amount of methane recorded in sample 223 was 

3,884.2 mL. (RX 248 at 5). 

2229. The amount of methane recorded from sample 224 was 4,761.8 mL. (RX 248 at 5). 

2230. In the test marked RX 248, the total mass of the sample “223” was 20 grams. (RX 

248 at 5). 

2231. The ECM additive, at 1% by weight, had a mass of 0.2 grams. (RX 248). 

2232. Based on Dr. Barlaz’s conservative calculation, the total theoretical yield of methane 

from 0.2 grams of the ECM additive is 186.6 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968). 

2233. At 3,884.2 mL, the amount of methane recorded from test sample “223” in RX 248 

was nearly twenty times the biodegradation that could have been sourced from the 

ECM additive alone. (RX 248 at 5; RX 968; Barlaz, Tr. 2252-58). 

2234. In the test marked RX 248, the total mass of the sample marked “224” was 20 grams. 

(RX 248). 

2235. The ECM additive, at 1% by weight, had a mass of 0.2 grams. (RX 248). 

2236. Based on Dr. Barlaz’s conservative calculation, the total theoretical yield of methane 

from the 0.2 grams of the ECM additive is 186.6 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968). 

2237. At 4,761.8 mL, the amount of methane recorded from the test sample “224” is more 

than twenty five times the amount of biodegradation that could have been sourced 

from the ECM additive alone. (RX 248 at 5; RX 968; Barlaz, Tr. 2252-58). 
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2238. The cumulative amount of methane collected from test RX 248 represented about 

fifty percent of the total gas emissions. (RX 248 at 5). 

2239. The study author, Eden Laboratories, reported that it was “obvious that 

biodegradation has occurred on the treated sample. (RX 248 at 6). 

2240. Based on the data collected, the study author reported that, as if the date of the report, 

“the treated sample is continuing to biodegrade.” (RX 248). 

b. RX 839, Eden Laboratories No. 070312C 

2241. In July 2012, Eden Laboratories reported test data from an anaerobic D5511 

biodegradation test in laboratory reactors. (RX 839). 

2242. ERL performed the test on behalf of Shields Bag & Printing. (RX 839 at 113977). 

2243. The test marked RX 839 followed the ASTM D5511 protocol. (RX 839 at 113977). 

The solid content of the test was 48.4%. (RX 839 at 113977). 

2244. The study authors recorded gas evolution data on a weekly basis. (RX 839 at 

113978-80). 

2245. The study authors calculated pH volumes, volatile fatty acids, and ammonium 

nitrogen levels. (RX 839 at 113977). 

2246. The test marked RX 839, as with all ERL D5511 tests, included the use of an 

inoculum blank, a negative control (polyethylene), a positive control (cellulose), a 

negative control consisting of an untreated plastic, and one test sample, all of which 

were run in triplicate. (RX 839 at 113982; Poth, Tr. 1466-67). 

2247. The test marked RX 839 included a “test” plastic sample amended with the ECM 

additive at 1% by weight. (RX 839 at 113978). 

2248. The test sample, marked “476A” was a clear film. (RX 839 at 113982). 

2249. The test marked RX 839 involved a negative control that was a “control film,” a 

plastic that was not amended with the ECM additive. (RX 839 at 113982). 

2250. The test marked RX 839 revealed biodegradation of the ECM amended plastic in the 

amount of 7.9% after 22 weeks of anaerobic testing. (RX 839 at 113982). 

2251. In the test marked RX 839, the amount of methane recorded in sample 476A was 

2,053.2 mL. (RX 839 at 113982). 

2252. In the test marked RX 839, the total mass of the sample “476A” was 20 grams. (RX 

839 at 113982). 
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2253. The ECM additive, at 1% by weight, had a mass of 0.2 grams. (RX 839; Barlaz, Tr. 

2252-58). 

2254. Based on Dr. Barlaz’s conservative calculation, the total theoretical yield of methane 

from 0.2 grams of the ECM additive is 186.6 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 2252-58). 

2255. At 2,053.2 mL, the amount of methane recorded from test sample “476A” in RX 839 

was eleven times the amount of biodegradation that could have been sourced from the 

ECM additive alone. (RX 839 at 113982; RX 968; Barlaz, Tr. 2252-58). 

2256. The amount of methane recorded in the inoculum blanks was just 792.7 mL. (RX 

839 at 113982). 

2257. The study author, Eden Laboratories, reported that it was “obvious that 

biodegradation has occurred on the treated sample.” (RX 839 at 113982). 

2258. Based on the data collected, the study author reported that, as if the date of the report, 

“the treated sample is continuing to biodegrade.” (RX 839 at 113982). 

c. RX 403, Eden Laboratories Fellows Test 

2259. In October 2012 through February 2013, Eden Laboratories reported test data from an 

anaerobic D5511 biodegradation test in laboratory reactors. (RX 403). 

2260. ERL performed the test on behalf of Fellows. (RX 403 at 001048). 

2261. The test marked RX 403 followed the ASTM D5511 protocol. (RX 403 at 001048). 

2262. The test report is an ERL “update.” (RX 403). 

2263. ERL produces update reports to keep customers abreast of the status of testing. (Poth, 

Tr. 1477). 

2264. Update reports do not include all of the information relevant to the test, or all of the 

information included in a final report. (Poth, Tr. 1475). 

2265. The test marked RX 403, as with all ERL D5511 tests, included the use of an 

inoculum blank, a negative control (polyethylene), a positive control (cellulose), two 

negative controls consisting of an untreated plastics, and two test samples, all of 

which were run in triplicate. (RX 403 at 001048; Poth, Tr. 1466-67). 

2266. The test marked RX 403 included two “test” plastic samples amended with the ECM 

additive at 1% by weight. (RX 403 at 001048). 
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2267. One test sample designated “568-P1004” included a “1% ECM BioFilm Resin.” (RX 

403 at 001048). 

2268. One test sample designated “570-TPU” included a “1% ECM BioFilm Resin Pink.” 

(RX 403 at 001048). 

2269. The test marked RX 403 involved negative controls that were control resins, plastics 

that was not amended with the ECM additive and contained “0% ECM.” (RX 403 at 

001052). 

2270. ERL recorded data for the test marked RX 403 through 197 days. (RX 403 at 

001052). 

2271. In the test marked RX 403, ERL recorded biodegradation of the ECM amended 

sample “568-P1004” in the amount of 71.8% after 197 days of anaerobic testing. 

(RX 403 at 001052). 

2272. For the sample marked 568-P1004, Dr. Barlaz calculated a net methane yield of 

7,548.9 mL, meaning that the test produced 7,548.9 mL more than the inoculum 

blanks. (RX 403; RX 968; Barlaz, Tr. 2252-58). 

2273. The total mass of the sample “568-P1004” was 20 grams. (RX 403 at 001052). 

2274. The ECM additive, at 1% by weight, had a mass of 0.2 grams. (RX 403; Barlaz, Tr. 

2252-58). 

2275. Based on Dr. Barlaz’s conservative calculation, the total theoretical yield of methane 

from 0.2 grams of the ECM additive is 186.6 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 2252-58). 

2276. At a net methane production of 7,548.9 mL, the amount of methane recorded from 

test sample “568-P1004” in RX 403 was more than forty times the amount that could 

have theoretically been sourced from the ECM additive. (RX 403 at 113982; RX 

968; Barlaz, Tr. 2252-58). 

2277. In the test marked RX 403, ERL recorded biodegradation of the ECM amended 

sample “570-TPU” in the amount of 16.1% after 197 days of anaerobic testing. (RX 

403 at 001052). 

2278. For the sample marked 570-TPU, Dr. Barlaz calculated a net methane yield of 

2,337.5 mL, meaning that the test produced 2,337.5 mL more than the inoculum 

blanks. (RX 403; RX 968; Barlaz, Tr. 2252-58). 

2279. The total mass of the sample “570-TPU” was 20 grams. (RX 403 at 001052). 
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2280. The ECM additive, at 1% by weight, had a mass of 0.2 grams. (RX 403; Barlaz, Tr. 

2252-58). 

2281. Based on Dr. Barlaz’s conservative calculation, the total theoretical yield of methane 

from 0.2 grams of the ECM additive is 186.6 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 2252-58). 

2282. At 2,337.5 mL, the amount of methane recorded from test sample “570-TPU” in RX 

403 was more than twelve times the amount of biodegradation that could have been 

sourced from the ECM additive alone. (RX 403 at 113982; RX 968; Barlaz, Tr. 

2252-58). 

2283. The ratio of mean substrate methane to mean inoculum methane was more than 5:1, 

indicating that the biodegradation observed in the test environment was confidently 

ascribed to the test article. (RX 968; Barlaz, Tr. 2247-50). 

d. RX 402, Eden Laboratories FP International Testing

2284. In October 2013 through February 2014, Eden Laboratories reported test data from an 

anaerobic biodegradation test in laboratory reactors. (RX 402). 

2285. ERL performed the test on behalf of FP International. (RX 402 at 001046). 

2286. The test marked RX 402 followed a modernized and more recent ASTM protocol. 

(RX 402 at 001046). 

2287. The test report is an ERL “update.” (RX 402). 

2288. ERL produces update reports to keep customers abreast of the status of testing. (Poth, 

Tr. 1477). 

2289. Update reports do not include all of the information relevant to the test, or all of the 

information included in a final report. (Poth, Tr. 1475). 

2290. The test marked RX 402, as with ERL biodegradation tests modeled after D5511, 

included the use of an inoculum blank, a negative control (polyethylene), a positive 

control (cellulose), a negative control consisting of an untreated plastic, and two test 

samples, all of which were run in triplicate. (RX 402 at 001046; Poth, Tr. 1466-67). 

2291. The test marked RX 402 included two “test” plastic sample amended with the ECM 

additive at 1% and 1.75% by weight. (RX 402 at 001046). 

2292. One test sample designated “726” included a “Film with 1% ECM.” (RX 402 at 

001046). 
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2293. One test sample designated “727” included a “Film with 1.75% ECM.” (RX 402 at 

001046). 

2294. The test marked RX 402 involved a negative control that was a control film 

containing “0% ECM.” (RX 402 at 001046). 

2295. ERL recorded data for the test marked RX 402 through 290 days. (RX 402 at 

001042). 

2296. There is no provision of D5511 that limits the amount of time under which a D5511 

test can be run. (RX 356). 

2297. In the test marked RX 402, ERL recorded biodegradation of the ECM amended 

sample “728” in the amount of 11.5% after 290 days of anaerobic testing. (RX 402 at 

1042). 

2298. For the sample marked 727, Dr. Barlaz calculated a net methane yield of 1,352.2 mL, 

meaning that the test produced 1,352.2 mL more than the inoculum blanks. (RX 402; 

RX 968; Barlaz, Tr. 2252-58). 

2299. The total mass of the sample “727” was 20 grams. (RX 402 at 001042; RX 968). 

2300. The ECM additive, at 1% by weight, had a mass of 0.35 grams. (RX 402; RX 968; 

Barlaz, Tr. 2252-58). 

2301. Based on Dr. Barlaz’s conservative calculation, the total theoretical yield of methane 

from 0.35 grams of the ECM additive is 326.55 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 2252-58). 

2302. At a net methane production of 1,352.2 mL, the amount of methane recorded from 

test sample “727” in RX 402 was more than four times the amount of biodegradation 

that could have theoretically been sourced from the ECM additive alone. (RX 402 at 

001042; RX 968; Barlaz, Tr. 2252-58). 

e. CCX-548, Eden Laboratories FP International Testing 

2303. In October 2013 through February 2014, Eden Laboratories reported test data from an 

anaerobic biodegradation test in laboratory reactors. (CCX 548). 

2304. ERL performed the test on behalf of FP International. (CCX 548 at 1). 

2305. The test marked CCX 548 followed a modernized and more recent ASTM protocol. 

(CCX 548 at 1). 

2306. The test report is an ERL “update.” (CCX 548). 
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2307. ERL produces update reports to keep customers abreast of the status of testing. (Poth, 

Tr. 1477). 

2308. Update reports do not include all of the information relevant to the test, or all of the 

information included in a final report. (Poth, Tr. 1475). 

2309. The test marked CCX 548, as with other ERL biodegradation tests modeled after 

D5511, included the use of an inoculum blank, a negative control (polyethylene), a 

positive control (cellulose), a negative control consisting of an untreated plastic, and a 

test sample, all of which were run in triplicate. (CCX 548 at 1; Poth, Tr. 1466-67). 

2310. The test marked CCX 548 included a “test” plastic amended with the ECM additive 

and labeled “723 – Biodegradable EPS FloPak.” (CCX 548 at 1). 

2311. ERL recorded data for the test marked CCX 548 through 291 days. (CCX 548 at 1). 

2312. There is no provision of D5511 that limits the amount of time under which a D5511 

test can be run. (RX 356). 

2313. In the test marked CCX 548, ERL recorded biodegradation of the ECM amended 

sample “723” in the amount of 30.4% after 291 days of anaerobic testing. (CCX 548 

at 1). 

2314. For the sample marked 723, ERL reported 2,705.9 mL of total methane, compared to 

just 383.4 mL of methane in the inoculum blank. (CCX 548 at 1). 

2315. The net methane is therefore 2322.5 mL in the “723” sample vessels. (CCX 548 at 

1). 

2316. The sample mass of the “723” test sample was 7.5 grams. (CCX 548 at 1). 

2317. The amount of the ECM additive is not provided in the report marked CCX 548. 

(CCX 548 at 1). 

2318. FP International testified at deposition that FP had manufactured a polystyrene 

product containing the ECM additive at 1% by weight. (RX 871 (Blood, Dep. at 57-

58)). 

2319. Even assuming that the ECM additive was introduced at 5% by weight, the weight of 

the ECM additive in the 7.5 gram “723” sample tested in CCX 548 would have been 

0.375 grams. (CCX 548; RX 968; Barlaz, Tr. 2252-58). 

2320. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from 0.375 grams of the ECM additive is 349.875 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 2252-58). 
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2321. At a net methane production of 2322.5 mL, the amount of methane recorded from test 

sample “723” in CCX 548 was more than 6.5 times the amount of biodegradation that 

could have theoretically been sourced from the ECM additive alone. (CCX 548 at 1; 

RX 968; Barlaz, Tr. 2252-58). 

f. CCX 546, Eden Laboratories FP International Testing 

2322. In November 2013, Eden Laboratories reported test data from an anaerobic D5511 

biodegradation test in laboratory reactors. (CCX 546). 

2323. ERL performed the test on behalf of FP International. (CCX 546 at 1). 

2324. The test marked CCX 546 is an ERL “update.” (CCX 546). 

2325. ERL produces update reports to keep customers abreast of the status of testing. (Poth, 

Tr. 1477). 

2326. Update reports do not include all of the information relevant to the test, or all of the 

information included in a final report. (Poth, Tr. 1475). 

2327. The test marked CCX 546, as with other ERL biodegradation tests modeled after 

D5511, included the use of an inoculum blank, a negative control (polyethylene), a 

positive control (cellulose), a negative control consisting of an untreated plastic, and 

two test samples, all of which were run in triplicate. (CCX 546 at 1; Poth, Tr. 1466-

67). 

2328. The test marked CCX 546 included two “test” plastic containing the ECM additive, 

labeled “223A-TKN Green” and “224A-HOP Green.” (CCX 546 at 1). 

2329. The ERL test marked CCX 546 does not report the amount of ECM additive included 

in the test samples. (CCX 546 at 1). 

2330. James Blood, FP International, testified at deposition that the test would have 

involved a 1% ECM additive product. (RX 871 (Blood, Dep. at 164-65)). 

2331. James Blood of FP International testified that the primary difference between the test 

samples marked “TKN” and “HOP” was the location or factory where the samples 

were manufactured. (RX 871 (Blood, Dep. at 164-65)). 

2332. ERL recorded data for the test marked CCX 546 through 977 days. (CCX 546 at 1). 

2333. There is no provision of D5511 that limits the amount of time under which a D5511 

test can be run. (RX 356). 
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2334. In the test marked CCX 546, ERL recorded biodegradation of the ECM amended 

sample “223A” in the amount of 36.7% after 977 days of anaerobic testing. (CCX 

546 at 1). 

2335. In the test marked CCX 546, ERL recorded biodegradation of the ECM amended 

sample “224A” in the amount of 39.8% after 977 days of anaerobic testing. (CCX 

546 at 1). 

2336. For the sample marked 223A, ERL reported 9,268.8 mL of total methane, compared 

to just 1,805.9 mL of methane in the inoculum blank. (CCX 546 at 1). 

2337. The net methane is therefore 7,462.9 mL in the “223A” sample vessels. (CCX 546 at 

1; RX 968; Barlaz, Tr. 2252-58). 

2338. For the sample marked 224A, ERL reported 9,970.8 mL of total methane, compared 

to just 1,805.9 mL of methane in the inoculum blank. (CCX 546 at 1; RX 968; 

Barlaz, Tr. 2252-58). 

2339. The net methane is therefore 8,164.9 mL in the “224A” sample vessels. (CCX 546 at 

1; RX 968; Barlaz, Tr. 2252-58). 

2340. The sample mass of the “223A” test sample was 20 grams. (CCX 546 at 1). 

2341. The sample mass of the “224A” sample was 20 grams. (CCX 546 at 1). 

2342. At 1% by weight, the sample mass of the ECM additive in the 223A and 224A 

samples was 0.20 grams. (RX 968; Barlaz, Tr. 2252-58). 

2343. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from 0.2 grams of the ECM additive is 186.6 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 2252-58). 

2344. At a net methane production of 7,462.9 mL, the amount of methane recorded from 

test sample “223A” in CCX 546 was about forty (40) times the amount that could 

have possibly been sourced from the ECM additive. (CCX 546 at 1; RX 968; Barlaz, 

Tr. 2252-58). 

2345. At a net methane production of 8,164.9 mL, the amount of methane recorded from 

test sample “224A” in CCX 546 was about forty-four (44) times the amount of 

biodegradation that could have possibly been sourced from the ECM additive. (CCX 

546 at 1; RX 968; Barlaz, Tr. 2252-58). 

g. CCX 534, Eden Laboratories MicroTek Testing
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2346. In May 2012 through March 2013, Eden Laboratories reported test data from an 

anaerobic D5511 biodegradation test in laboratory reactors. (CCX 534). 

2347. ERL performed the test on behalf of MicroTek. (CCX 534 at 009017). 

2348. The test marked CCX 534 was performed on a polyethylene film. (CCX 534 at 

009017). 

2349. The test marked CCX 534 is an ERL “update.” (CCX 534). ERL produces update 

reports to keep customers abreast of the status of testing. (Poth, Tr. 1477). 

2350. Update reports do not include all of the information relevant to the test, or all of the 

information included in a final report. (Poth, Tr. 1475). 

2351. The test marked CCX 534, as with other ERL biodegradation tests modeled after 

D5511, included the use of an inoculum blank, a negative control (polyethylene), a 

positive control (cellulose), a negative control consisting of an untreated plastic, and a 

test sample, all of which were run in triplicate. (CCX 534 at 009017; Poth, Tr. 1466-

67). 

2352. The test marked CCX 534 included a “test” plastic amended with the ECM additive, 

labeled “BIO10115 ECM FILM.” (CCX 534 at 009017). 

2353. The ERL test marked CCX 534 does not report the amount of ECM additive included 

in the test samples. (CCX 534 at 009017). 

2354. ERL recorded data for the test marked CCX 534 through 485 days. (CCX 534 at 

009017). 

2355. There is no provision of D5511 that limits the amount of time under which a D5511 

test can be run. (RX 356). 

2356. In the test marked CCX 534, ERL recorded biodegradation of the ECM amended 

sample “BIO10115” in the amount of 45.2% after 485 days of anaerobic testing. 

(CCX 534 at 009017). 

2357. For the sample marked BIO10115, ERL reported 7,588.2 mL of total methane, 

compared to just 1,781.7 mL of methane in the inoculum blank. (CCX 534 at 

009017). 

2358. The net methane is therefore 5,806.5 between the test vessels and the inoculum 

vessels. (CCX 534 at 009017; RX 968; Barlaz, Tr. 2252-58). 

2359. The sample mass of the “BIO10115” test sample was 13 grams. (CCX 534 at 

009017). 
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2360. Even assuming that the ECM additive was included at 5% by weight, the sample 

mass of the ECM additive in the BIO10115 sample would have been 0.65 grams. 

(CCX 534 at 009017; RX 968; Barlaz, Tr. 2252-58). 

2361. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from 0.65 grams of the ECM additive is 606.45 mL of methane, calculated by 

multiplying the grams of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 2252-58). 

2362. At a net methane production of 5,806.5 mL, the amount of methane recorded from 

test sample “BIO10115” in CCX 534 was about nine and one half (9.5x) times the 

amount of biodegradation could have possibly been sourced from the ECM additive. 

(CCX 534 at 009017; RX 968; Barlaz, Tr. 2252-58). 

h. CCX 547, Eden Laboratories EcoLab Testing 

2363. In March 2013 through September 2013, Eden Laboratories reported test data from an 

anaerobic D5511 biodegradation test in laboratory reactors. (CCX 547). 

2364. ERL performed the test on behalf of EcoLab. (CCX 547 at 009008). 

2365. The test marked CCX 547 is an ERL “update.” (CCX 547). 

2366. ERL produces update reports to keep customers abreast of the status of testing. (Poth, 

Tr. 1477). 

2367. Update reports do not include all of the information relevant to the test, or all of the 

information included in a final report. (Poth, Tr. 1475). 

2368. The test marked CCX 547, as with other ERL biodegradation tests modeled after 

D5511, included the use of an inoculum blank, a negative control (polyethylene), a 

positive control (cellulose), and a test sample, all of which were run in triplicate. 

(CCX 547 at 009017; Poth, Tr. 1466-67). 

2369. The test marked CCX 547 included two “test” plastic containing the ECM additive, 

on sample labeled “538A BIO10115 ECM Film,” and another sample labeled “539A 

BIO10115 ECM Film.” (CCX 547 at 009008). 

2370. ERL recorded data for the test marked CCX 547 through 452 days. (CCX 547 at 

009004-08). 

2371. There is no provision of D5511 that limits the amount of time under which a D5511 

test can be run. (RX 356). 
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2372. In the test marked CCX 547, ERL recorded biodegradation of the ECM amended 

sample “538A” in the amount of 19.6% after 452 days of anaerobic testing. (CCX 

547 at 009008). 

2373. In the test marked CCX 547, ERL recorded biodegradation of the ECM amended 

sample “539A” in the amount of 46.5% after 452 days of anaerobic testing. (CCX 

547 at 009008). 

2374. The ERL test marked CCX 547 does not report the amount of ECM additive included 

in the test samples. (CCX 547 at 009008). 

2375. For the sample marked 538A, ERL reported 5,356.4 mL of total methane, compared 

to just 1093.3 mL of methane in the inoculum blank. (CCX 547 at 009008). 

2376. The net methane for sample 538A is therefore 4,263.1 mL between the test vessels 

and the inoculum vessels. (CCX 547 at 009008; RX 968; Barlaz, Tr. 2252-58). 

2377. For the sample marked 539A, ERL reported 9,778.7 mL of total methane, compared 

to 1093.3 mL of methane in the inoculum blank. (CCX 547 at 009008). 

2378. The net methane for sample 539A is therefore 8,685.4 mL between the test vessels 

and the inoculum vessels. (CCX 547 at 009008; RX 968; Barlaz, Tr. 2252-58). 

2379. The sample masses of the “538A” and “539A” test samples were 20 grams each. 

(CCX 547 at 009008). 

2380. Even assuming that the ECM additive was included at 5% by weight in the 538A 

sample (an amount higher than the 1-2% that customers ordinarily use), the sample 

mass of the ECM additive in the 538A sample would have been 1 gram. (CCX 547 at 

009008; RX 968; Barlaz, Tr. 2252-58). 

2381. Even assuming that the ECM additive was included in the 539A sample at 15% (an 

amount substantially higher than the 1-2% that customers ordinarily use), the sample 

mass of the ECM additive in the 539A sample would have been 3 grams. (CCX 547 

at 009008; RX 968; Barlaz, Tr. 2252-58). 

2382. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from 1 gram of the ECM additive is 933 mL of methane, calculated by multiplying 

the grams of ECM additive by Dr. Barlaz’s calculation of the mL of methane per 

gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 2252-58). 

2383. The total theoretical yield of methane from 3 grams of the ECM additive is 2,799 mL, 

calculated by multiplying the grams of ECM additive by Dr. Barlaz’s calculation of 

the mL of methane per gram of ECM additive in the sample. (RX 968; Barlaz, Tr. 

2252-58). 
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2384. At a net methane production of 4,263.1 mL, the amount of methane recorded from 

test sample “538A” in CCX 547 was more than four and one half (4.5x) times the 

amount of biodegradation (933 mL) that could have possibly been sourced from the 

ECM additive assuming even a 5% load rate for same. (CCX 547 at 009008; RX 

968; Barlaz, Tr. 2252-58). 

2385. At a net methane production of 8,685.4 mL, the amount of methane recorded from 

test sample “539A” in CCX 547 was more than three (3x) times the amount of 

biodegradation (2,799 mL) that could have possibly been sourced from the ECM 

additive assuming even a 15% load rate for same. (CCX 547 at 009008; RX 968; 

Barlaz, Tr. 2252-58). 

1. Northeast Laboratories Testing Generally 

2386. Alan Johnson testified as the owner of Northeast Laboratories (“NE Labs”) in Berlin, 

Connecticut. (Johnson, Tr. 1554-57). 

2387. Alan Johnson serves as the current laboratory director at Northeast Laboratories. 

(Johnson, Tr. 1554). 

2388. Mr. Johnson has a bachelor’s of science from the University of Connecticut where he 

majored in biology and minored in chemistry. (Johnson, Tr. 1555). 

2389. Northeast Laboratories houses several laboratory divisions at its offices, including 

chemistry and microbiology labs. (Johnson, Tr. 1556-58). 

2390. NE Labs environmental and chemistry laboratory divisions have been certified by 

several governmental bodies, including the EPA, FDA, CDC, and the State of 

Connecticut. (Johnson, Tr. 1558). 

2391. NE Labs’ biodegradation testing is a branch of NE Lab’s testing services, however 

NE Labs relies on its other laboratory divisions, including its chemistry lab, for 

portions of the biodegradation testing work. (Johnson, Tr. 1560-61). 

2392. With respect to its certifications, NE Labs has been inspected by governmental 

bodies, and NE Labs passed those inspections. (Johnson, Tr. 1559-61). 

2393. NE Labs began performing biodegradation testing around 2005. (Johnson, Tr. 1560). 

2394. NE Labs’ biodegradation testing business was initiated and operated by Dr. William 

Ullmann. (Johnson, Tr. 1560). 

2395. Dr. Ullmann founded NE Labs in 1977. (Johnson, Tr. 1562). 
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2396. He was the former director of the State of Connecticut’s Public Health Laboratory. 

(Johnson, Tr. 1562). 

2397. Dr. Ullmann had a Ph.D. in microbiology. (Johnson, Tr. 1562). 

2398. Dr. Ullmann was responsible for developing NE Lab’s biodegradation testing 

protocols, and he performed those studies until he passed away in 2011. (Johnson, 

Tr. 1563). 

2399. NE Labs would begin biodegradation testing by obtaining test samples directly from 

customers, and then calculating the carbon content of same. (Johnson, Tr. 1564). 

2400. NE Labs generally follows the ASTM D5511 protocol, but NE Labs uses metal 

canisters as reactor vessels instead of glass vessels. (Johnson, Tr. 1565). 

2401. NE Labs metal canisters are specially manufactured for biodegradation testing. 

(Johnson, Tr. 1565). 

2402. NE Labs drills into the metal canisters and threads a fitting into the can so that the test 

tubing is airtight and feeds directly from the reactor into the graduated cylinder, 

where gas volume is measured. (Johnson, Tr. 1565-1566). 

2403. The ASTM D5511 method specifically calls for the use of a graduated cylinder to 

measure total gas volume. (RX 356, at 2 § 6.1). 

2404. NE Labs uses lined paint cans to prevent corrosion. (Johnson, Tr. 1566). 

2405. The issue of corrosion was never an issue in NE Lab’s shorter-duration studies. 

(Johnson, Tr. 1565-66). 

2406. In longer duration studies during the early years when NE Labs used unlined 

canisters, corrosion may have been an issue to the extent that NE Labs observed rust 

forming on the can. (Johnson, Tr. 1566). 

2407. NE Labs seals its canisters with silicone caulking and then seals each container with a 

resin. (Johnson, Tr. 1567). 

2408. NE Labs never had any indications that its test systems leaked or were not gas tight. 

(Johnson, Tr. 1566-67). 

2409. A canister that was leaking would be quite obvious. (Johnson, Tr. 1567-68). 

2410. NE Labs could determine whether its test vessels leaked or were airtight because if 

the canisters had leaked, then the water level in the graduated cylinder (used for gas 

collection) would be lowered. (Johnson, Tr. 1566-67). 
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2411. NE Labs could determine that the test environment was not aerobic (or gaining 

oxygen) because the test vessels were producing methane, and the D5511 tests used 

methane as a marker for biodegradation. (Johnson, Tr. 1566-67). 

2412. The presence of methane means that the test environment is anaerobic. (Johnson, Tr. 

1566-67, 1570). 

2413. NE Labs extracted gas from the cylinder through an extraction valve in the test 

tubing. (Johnson, Tr. 1568-69). 

2414. NE Labs uses a Quantek analyzer to analyze carbon dioxide. (Johnson, Tr. 1569). 

2415. NE Labs uses an infrared (“IR”) spectrometer to measure methane content. (Johnson, 

Tr. 1569). 

2416. The precision of the IR spectrometer varies depending on the amount of methane 

detected in the system. (Johnson, Tr. 1586-87). 

2417. However, for the higher readings of methane that NE Labs was looking at, the 

precision of the instrument was probably around plus or minus 1 percent. (Johnson, 

Tr. 1587). 

2418. Because NE Lab’s test vessels have “head space” at the top of the canisters, the 

canisters contain ambient gases that are not produced from the biological processes in 

the tests. (Johnson, Tr. 1591-92). 

2419. The ambient gases in the headspace are also collected in the graduated cylinder so 

that the gas composition would include a percentage of ambient gas unassociated with 

the inoculum or biota. (Johnson, Tr. 1591-92). 

2420. The biodegradation process produces carbon dioxide and methane, the presence of the 

latter in relatively equal proportions to the carbon dioxide is an indication that the test 

environment is anaerobic (as opposed to aerobic). (Johnson, Tr. 1566-67; Barlaz, Tr. 

2188-89). 

2421. NE Labs uses a standard format for its biodegradation test reports. (Johnson, Tr. 

1571). Mr. Johnson testified that the reports in evidence from NE Labs are in the 

format of NE Lab’s standard reports. (Johnson, Tr. 1571-72). 

2422. NE Labs performed “extension” biodegradation testing for certain customers. 

(Johnson, Tr. 1573). 

2423. For longer-term extension testing over 45 days past the planned termination date, NE 

Labs would assess whether the activity in the triplicate vessels had levelled off. 

(Johnson, Tr. 1573-74). 
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2424. If the activity in the test vessels had leveled, and the positive control had already been 

digested, NE Labs would remove the test materials and negative controls from the 

stale testing environment, and place those materials into a new reactor canister with 

fresh inoculum. (Johnson, Tr. 1573-74). 

2425. To maintain anaerobic conditions during a long-term extension test, NE Labs would 

sparge (or flush) the new canisters with nitrogen to remove excess atmospheric gases. 

(Johnson, Tr. 1573-74). 

2426. When using fresh canisters with fresh inoculum to extend tests, NE Labs would 

always use fresh inoculum blanks, and often fresh negative control vessels. (Johnson, 

Tr. 1574-75). 

2427. There is no evidence in the record that NE Labs changed canisters during 

biodegradation testing of ECM amended plastics. (Johnson, Tr. 1560-1596). 

2428. There is no evidence in the record that corrosion of canisters occurred in 

biodegradation testing of ECM amended plastics. (Johnson, Tr. 1557-96). 

2429. There is no evidence in the record of leakage in the metal canisters that NE Labs used 

in biodegradation testing of ECM amended plastics. (Johnson, Tr. 1560-96). 

2430. Dr. Barlaz reviewed NE Lab’s testing protocol. (Barlaz, Tr. 2276). 

2431. Dr. Barlaz testified that NE Lab’s use of metal canisters in D5511 testing would not 

affect the validity of NE Lab’s test results. (Barlaz, Tr. 2276). 

2432. With respect to NE Lab’s use of metal canisters, Dr. Barlaz explained that “you either 

have a leak in your system or you don’t have a leak in your system, and if you don’t 

have a leak in your system, then a metal can should be fine.” (Barlaz, Tr. 2276). 

2433. “And the fact that [NE Labs] were getting methane generation from their positive 

controls indicate[d] to [Dr. Barlaz] that [NE Labs] have an ability to make a gas-tight 

system out of a metal can.” (Barlaz, Tr. 2276). 

2434. The presence of methane in NE Labs testing proves that the test environment was 

anaerobic “because oxygen kills methanogens” responsible for producing methane. 

(Barlaz, Tr. 2277). 

2435. Complaint Counsel presented no evidence through their experts that NE Labs use of 

metal canisters resulted in a methodologically flawed test. (Tolaymat, Tr. 112-213; 

McCarthy, Tr. 359-480). 

2436. With respect to D5511 tests that showed ECM amended plastics were biodegradable, 

Dr. McCarthy testified in vague and general terms simply that “there are some tests 
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that were conducted well and some tests that were conducted poorly.” (McCarthy, 

Tr. 452). 

2437. He also testified vaguely that the tests that are problematic “are the ones that are the 

5511 that were conducted at the very, very long periods of time and indicate a lot of 

leakage.” (McCarthy, Tr. 452). 

2438. Dr. McCarthy did not identify which tests he thought exhibited any leakage. 

(McCarthy, Tr. 452-54). 

2439. He did not identify any evidence of “leakage” in any of ECM’s supportive tests. 

(McCarthy, Tr. 359-480). 

2440. He rejected tests outright because they were run for periods of time longer than 30 

days. (McCarthy, Tr. 454-55). 

2441. Dr. Tolaymat, by contrast, testified that a D5511 test could be conducted for several 

years while remaining viable. (Tolaymat, Tr. 251). 

2442. Complaint Counsel’s rebuttal expert, Dr. Michel, performed biodegradation gas 

evolution studies in his laboratory that exceeded 500 days. (Michel, Tr. 2899). 

2443. Dr. McCarthy provided no evidence or explanation for how a small leakage in the NE 

Lab’s system, even assuming that occurred, would affect the evidence of 

biodegradation observed. (McCarthy, Tr. 359-480). 

2444. Dr. McCarthy did not explain whether a small leak in the NE Labs system would 

actually minimize the data on biodegradation, logically lowering the appearance of 

any observable affect. (McCarthy, Tr. 359-480). 

2445. Dr. McCarthy apparently failed to understand NE Labs’ display of averaged gas 

readings when he criticized test readings that were “exactly the same.” (McCarthy, 

Tr. 454). 

2446. NE Labs used weekly gas measurements and would report the data for individual 

days based on an average from the weekly readings. (RX 873 (Ullmann, Dep. at 61)). 

2447. The percentage of total biodegradation is based on total gas volume, which would not 

be influenced by NE Labs decision to display weekly gas readings in that fashion. 

(RX 356). 

2448. Dr. McCarthy criticized ECM studies, including NE Lab’s studies, because there 

were no “error bars or standard deviations or standard error given” in the tests. 

(McCarthy, Tr. 454-55). 
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2449. Although NE Labs raw data was available to Dr. McCarthy, he offered no statistical 

assessment of the data, and made no attempt to base his testimony on a specific 

review of the gas evolution data generated in the tests. (McCarthy, Tr. 359-480). 

2450. Dr. Sahu testified that he had no concerns with NE Lab’s methodology. (Sahu, Tr. 

1933-34). 

2451. Dr. Sahu was not concerned with the process of reinoculating the test vessels in longterm D5511 studies. (Sahu, Tr. 1933-34). 

2452. Dr. Sahu was satisfied that the amount of biogas produced in the ECM tests that was 

in excess of that which could come from the inoculum was sufficient to show that the 

plastic itself had been rendered biodegradable. (Sahu, Tr. 1934-35). 

2453. With respect to NE Labs testing, or any gas evolution testing relevant to the case, Dr. 

McCarthy did not perform statistical analyses of the data. (McCarthy, Tr. 359-480). 

2454. Although Dr. McCarthy possessed Dr. Barlaz’s statistical analyses of the data, Dr. 

McCarthy offered no evidence or testimony concerning Dr. Barlaz’s analysis of the 

gas evolution data. (McCarthy, Tr. 359-480). 

2455. Dr. McCarthy did not even mention Dr. Barlaz’s analysis of data. (McCarthy, Tr. 

359-480). 

a. RX 836, NE Labs N1048340 (PPC Industries, Inc.) Testing 

2456. From September 2010 through November 2013, NE Labs reported biodegradation 

test data from an anaerobic D5511 biodegradation test in laboratory reactors. (RX 

836). 

2457. NE Labs performed the test on behalf of PPC Industries, Inc. (RX 836 at 1). 

2458. The test marked RX 836 is an NE Labs analytical report of the type normally 

supplied by NE Labs. (RX 836; Johnson, Tr. 1571). 

2459. The test marked RX 836, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of an inoculum blank, a negative control (untreated plastic), a 

positive control (cellulose), and a test sample, all of which were run in triplicate. (RX 

836 at 2; Johnson, Tr. 1575). 

2460. The test marked RX 836 included a plastic amended with 1% ECM additive. (RX 

155; RX 156; RX 157). 
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2461. The plastic sample was labeled “EP Flex Renew Green Poly Bags Treated,” and the 

test involved an untreated “Clear Poly Bag” sample as a negative control. (RX 836 at 

2). 

2462. NE Labs recorded data for the test marked RX 836 through 900 days. (RX 836 at 126 

(10/21/2013 Report)). 

2463. There is no provision of D5511 that limits the amount of time under which a D5511 

test can be run. (RX 356). 

2464. In the test marked RX 836, NE Labs recorded biodegradation of the ECM amended 

sample “EP Flex Renew Green Poly Bags Treated” in the amount of 49.28% after 

900 days of anaerobic testing. (RX 836 at 126 (10/21/2013 Report)). 

2465. The negative control in RX 836 revealed just 0.1152% total biodegradation after 900 

days of anaerobic biodegradation testing. (RX 836 at 126 (10/21/2013 Report)). 

2466. Dr. Barlaz reviewed the raw data provided by NE Labs, including data pertaining to 

RX 836. (RX 836; RX 968; Barlaz, Tr. 2252-58). 

2467. For the sample “EP Flex Renew Green Poly Bags Treated,” NE Labs reported 4,716 

mL of total methane, compared to just 1,854 mL of methane in the inoculum blank. 

(RX 836; RX 472; RX 968). 

2468. The net methane yield between the inoculum and the test vessel in RX 836 was 

2,862.4 mL. (RX 836; RX 472; RX 968). 

2469. Dr. Barlaz calculated the mean substrate to inoculum ratio at 2.5 for this test, 

affirming that the methane content observed in the test vessels was from the test 

substrate (the plastic). (RX 836; RX 968; Barlaz, Tr. 2247-49, 2260-63). 

2470. Dr. Barlaz calculated methane and carbon dioxide t-statistics, and determined that the 

results of RX 836 were statistically significant. (RX 968; Barlaz, Tr. 2259-60). 

2471. The mass of the test sample in RX 836 was 20 grams. (RX 836 at 1). 

2472. At 1% by weight, the mass of the ECM additive in the sample test was approximately 

0.2 grams. (RX 836; RX 968; Barlaz, Tr. 2251-54). 

2473. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from the 1% ECM additive tested in RX 836 is 186.6 mL of methane, calculated by 

multiplying the weight of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive (933 mL). (RX 968; Barlaz, Tr. 2252-58). 

2474. At a net methane yield of 2,862.4 mL, the biodegradation of the test substrate in RX 

836 was more than fifteen (15x) times the amount of biodegradation that could have 
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possibly been sourced from the ECM additive alone. (RX 836; RX 968; Barlaz, Tr. 

2252-58). 

2475. Dr. Barlaz also calculated standard deviations for RX 836, which were within 

reasonable limits as expressed by the t-statistics. (RX 968; RX 472; Barlaz, Tr. 

2264). 

2476. Based, in part, on RX 836, Dr. Barlaz testified that the scientific evidence showed 

that plastic containing the ECM additive anaerobically biodegraded. (RX 968; 

Barlaz, Tr. 2274). 

b. RX 838, NE Labs 1149980 (MINIGRIP) Testing 

2477. From May 2011 through August 2012, NE Labs reported biodegradation test data 

from an anaerobic D5511 biodegradation test in laboratory reactors. (RX 838). 

2478. NE Labs performed the test on behalf of Minigrips in Kennesaw, GA. (RX 838 at 1). 

2479. The test marked RX 838 is an NE Labs analytical report of the type normally 

supplied by NE Labs. (RX 838; Johnson, Tr. 1571). 

2480. The test marked RX 838, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of an inoculum blank, a negative control (untreated plastic), a 

positive control (cellulose), and a test sample, all of which were run in triplicate. (RX 

838 at 2; Johnson, Tr. 1575). 

2481. The test marked RX 838 included a plastic amended with 1.5% ECM additive. (RX 

838). 

2482. The plastic sample was labeled “#1149980-01 Zip Bags, Green Line LDPE/LLDPE 

Treated, 1.5% ECM (25 Grams),” and the test involved an untreated control labeled 

“#1149980-02 Zip Bags, Red Line LDPE/LLDPE Untreated (25 Grams). (RX 838 at 

1). 

2483. NE Labs recorded data for the test marked RX 838 through 365 days. (RX 838 at 72 

(6/4/2012 Report)). 

2484. There is no provision of D5511 that limits the amount of time under which a D5511 

test can be run. (RX 356). 

2485. In the test marked RX 838, NE Labs recorded biodegradation of the ECM amended 

sample “#1149980-01” in the amount of 17.069% after 365 days of anaerobic testing. 

(RX 838 at 72 (6/4/2012 Report)). 
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2486. The negative control in RX 838 revealed just 0.1009% total biodegradation after 365 

days of anaerobic biodegradation testing. (RX 838 at 72 (6/4/2012 Report)). 

2487. Dr. Barlaz reviewed the raw data provided by NE Labs, including data pertaining to 

RX 838. (RX 838; RX 968; Barlaz, Tr. 2252-58). 

2488. For the sample “#1149980-01,” NE Labs reported 5,197 mL of total methane, 

compared to just 1,360 mL of methane in the inoculum blank. (RX 838; RX 472; RX 

968). 

2489. The net methane yield between the inoculum and the test vessel in RX 838 was 

3,837.3 mL. (RX 838; RX 472; RX 968). 

2490. Dr. Barlaz calculated the mean substrate to inoculum ratio at 3.8 for this test, 

affirming that the methane content observed in the test vessels was from the test 

substrate (the plastic). (RX 838; RX 968; Barlaz, Tr. 2247-49, 2260-63). 

2491. Dr. Barlaz calculated methane and carbon dioxide t-statistics, and determined that the 

results of RX 838 were statistically significant. (RX 472; RX 968; Barlaz, Tr. 2259-

60). 

2492. The mass of the test sample in RX 838 was 25 grams. (RX 838 at 1). 

2493. At 1.5% by weight, the mass of the ECM additive in the sample test was 

approximately 0.375 grams. (RX 838; RX 968; Barlaz, Tr. 2251-54). 

2494. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from the 1.5% ECM additive tested in RX 838 is 349.875 mL of methane, calculated 

by multiplying the weight of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive (933 mL). (RX 968; Barlaz, Tr. 2252-58). 

2495. At a net methane (CH4) yield of 3,837.3 mL, the biodegradation of the test plastic in 

RX 838 was about eleven (11x) times the amount of biodegradation that could have 

possibly been sourced from the ECM additive alone. (RX 838; RX 968; Barlaz, Tr. 

2252-58). 

2496. Dr. Barlaz also calculated standard deviations for RX 838, which were within 

reasonable limits as expressed by the t-statistics. (RX 968; RX 472; Barlaz, Tr. 

2264). 

2497. Based in part on RX 838, Dr. Barlaz testified that the scientific evidence showed that 

plastic containing the ECM additive anaerobically biodegraded. (RX 968; Barlaz, Tr. 

2274). 
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2498. Along with its RX 838 test, NE Labs also performed an Analytical Report under 

ASTM D6579 to determine the molecular weight averages and molecular weight 

distribution of the test sample after completion of the biodegradation test. (RX 838 at 

73 (8/1/2012 Report)). 

2499. In its August 1, 2012 Analytical Report (RX 838), NE Labs demonstrated that the 

plastic “zip bags” treated with the 1.5% ECM additive had lost molecular weight after 

biodegradation testing. (RX 838 at 73 (8/1/2012 Report)). 

2500. Both the “number average” and the “weight average” molecular weights of the 1.5% 

ECM treated plastic had declined by about 16%, as measured using a different ASTM 

standard, ASTM D6579. (RX 838 at 73 (8/1/2012 Report)). 

2501. For comparison, the biodegradation percentage recorded by NE Labs at the end of the 

RX 838 testing, measured by methane conversion, was listed at about 17%. (RX 838 

at 72 (6/4/2012 Report)). 

2502. In comments written on NE Lab’s certificate of analysis, NE Labs explained that 

“change in molecular weight is a measure of bulk deterioration. 

2503. As an analytical method it indicates that polymer chains are breaking down or 

cleaving during biodegradation.” (RX 838 at 73 (8/1/2012 Report)). 

2504. The NE Labs Minigrips test (RX 838) demonstrated about 6% biodegradation based 

on methane conversion after 30 days of testing, before ultimately continuing to 

biodegrade to more than 17% after 365 days of testing. (RX 838 at 6 (6/13/2011 

Report)). 

2505. Having reviewed the Minigrips data, Mr. Johnson testified that by the end of the test 

there was virtually no activity of any kind occurring in any of the test vessels. 

(Johnson, Tr. 1589-90). 

c. RX 398, NE Labs N0946510-01 (Masternet I) Testing 

2506. In December 2009, NE Labs reported biodegradation test data from an anaerobic 

D5511 biodegradation test in laboratory reactors. (RX 398). 

2507. NE Labs performed the test on behalf of Masternet Ltd. in Mississauga, Ontario, 

Canada. (RX 398 at 1). 

2508. The test marked RX 398 is an NE Labs analytical report of the type normally 

supplied by NE Labs. (RX 398; Johnson, Tr. 1571). 

2509. The test marked RX 398, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of an inoculum blank, a negative control (untreated plastic, here 
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polyethylene), a positive control (cellulose), and a test sample, all of which were run 

in triplicate. (RX 398 at 2; Johnson, Tr. 1575). 

2510. The test marked RX 398 included a polyethylene plastic amended with 1% ECM 

additive. (RX 398 at 1). 

2511. The plastic test sample had an initial weight of 25 grams. (RX 398 at 2). 

2512. NE Labs recorded data for the test marked RX 398 through 15 days. (RX 398 at 4). 

2513. In the test marked RX 398, NE Labs recorded biodegradation of the ECM amended 

polyethylene in the amount of 4.91% after 15 days of anaerobic testing. (RX 398 at 

4). 

2514. The 4.91% biodegradation within 15 days of anaerobic testing, calculated based on 

methane conversion, is more than the 3.65% biodegradation observed in the first 15 

days of testing in NE Labs RX 838, which test would later produce more than 17% 

biodegradation over 365 days. (RX 398 at 4; RX 838 at 6 (6/13/2011 Report)). 

2515. Dr. Barlaz reviewed the raw data provided by NE Labs, including data pertaining to 

RX 398. (RX 398; RX 472; RX 968; Barlaz, Tr. 2252-58). 

2516. For the ECM amended plastic, NE Labs reported 2,628 mL of total methane, 

compared to 1,554 mL of methane in the inoculum blank. (RX 398; RX 472; RX 

968). 

2517. The net methane yield between the inoculum and the test vessel in RX 398 was 

1,074.3 mL. (RX 398; RX 472; RX 968). 

2518. Dr. Barlaz calculated methane and carbon dioxide t-statistics, and determined that the 

results of RX 398 were statistically significant. (RX 472; RX 968; Barlaz, Tr. 2259-

60). 

2519. The mass of the 1% ECM amended polyethylene sample in RX 398 was 25 grams. 

(RX 398 at 1). 

2520. At 1% by weight, the mass of the ECM additive in the sample test was approximately 

0.25 grams. (RX 398; RX 968; Barlaz, Tr. 2251-54). 

2521. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from the 1% ECM additive tested in RX 398 is 233.25 mL of methane, calculated by 

multiplying the weight of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive (933 mL). (RX 968; Barlaz, Tr. 2252-58). 

2522. At a net methane (CH4) yield of 1,074.3 mL, the biodegradation of the test plastic in 

RX 398 was more than four and one half (4.5x) times the amount of biodegradation 
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that could have possibly been sourced from the ECM additive alone, all during the 

short fifteen (15) day test window. (RX 398; RX 968; Barlaz, Tr. 2252-58). 

d. RX 405, NE Labs 1048742-01 (Eco SmartPlastics) Testing 

2523. In November 2010, NE Labs reported biodegradation test data from an anaerobic 

D5511 biodegradation test in laboratory reactors. (RX 405). 

2524. NE Labs performed the test on behalf of Eco SmartPlastics in Bohemia, New York. 

(RX 405 at 1). 

2525. The test marked RX 405 is an NE Labs analytical report of the type normally 

supplied by NE Labs. (RX 405; Johnson, Tr. 1571). 

2526. The test marked RX 405, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of an inoculum blank, a negative control (untreated plastic, here 

polypropylene), a positive control (cellulose), and a test sample, all of which were run 

in triplicate. (RX 405 at 2; Johnson, Tr. 1575). 

2527. The test marked RX 405 included a low-density polyethylene plastic (LDPE) 

amended with 1.5% ECM additive. (RX 405 at 1). 

2528. The plastic test sample had an initial weight of 25 grams. (RX 405 at 1). 

2529. NE Labs recorded data for the test marked RX 405 through 45 days. (RX 405 at 3). 

2530. In the test marked RX 405, NE Labs recorded biodegradation of the ECM amended 

low-density polyethylene in the amount of 7.37% after 45 days of anaerobic testing. 

(RX 405 at 3). 

2531. The 7.37% biodegradation within 45 days of anaerobic testing, calculated based on 

methane conversion, is roughly equal to the 7.53% biodegradation observed in the 

first 45 days of testing in NE Labs RX 838 (Minigrips Test), which latter test would 

reveal more than 17% biodegradation over 365 days. (RX 405 at 3; RX 838 at 9 

(7/5/2011 Report)). 

2532. The 17% biodegradation of the test substrate in the NE Labs RX 838 Minigrips test 

was confirmed through molecular weight testing, and far exceeded the amount of 

biodegradation that could have been sourced from the ECM additive alone. (RX 838; 

RX 968; Barlaz, Tr. 2252-58). 

e. RX 396, NE Labs 1048819 (Eco SmartPlastics) Testing 

2533. In December 2010, NE Labs reported biodegradation test data from an anaerobic 

D5511 biodegradation test in laboratory reactors. (RX 396). 
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2534. NE Labs performed the test on behalf of Eco SmartPlastics in Bohemia, New York. 

(RX 396 at 1). 

2535. RX 396 is an NE Labs analytical report of the type normally supplied by NE Labs. 

(RX 396; Johnson, Tr. 1571). 

2536. The test marked RX 396, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of an inoculum blank, a negative control (untreated plastic, here 

polypropylene), a positive control (cellulose), and a test sample, all of which were run 

in triplicate. (RX 396 at 1-2; Johnson, Tr. 1575). 

2537. The test marked RX 396 included a polyethylene terephthalate (PET) plastic amended 

with the ECM additive. (RX 396 at 1; CCX 413). 

2538. The plastic test sample had an initial weight of 25 grams. (RX 396 at 1). 

2539. The test report (RX 396) does not specify the amount of ECM additive included in 

the test plastic. (RX 396). 

2540. Eco SmartPlastics used a 1.5% load rate for the ECM additive in other plastic 

applications. (RX 405 at 1). 

2541. NE Labs recorded data for the test marked RX 396 through 43 days. (RX 396 at 3). 

2542. In the test marked RX 396, NE Labs recorded biodegradation of the ECM amended 

polyethylene in the amount of 7.01% after 45 days of anaerobic testing. (RX 396 at 

4). 

2543. The 7.01% biodegradation within 45 days of anaerobic testing, calculated based on 

methane conversion, is roughly equal to the 7.53% biodegradation observed in the 

first 45 days of testing in NE Labs RX 838 (Minigrips Test), which latter test would 

reveal more than 17% biodegradation over 365 days. (RX 396 at 4; RX 838 at 9 

(7/5/2011 Report)). 

2544. For the ECM amended plastic, NE Labs reported 3,496 mL of total methane, 

compared to 1,821 mL of methane in the inoculum blank. (RX 396 at 4). 

2545. The net methane yield between the inoculum and the test vessel in RX 396 was 

therefore 1,675 mL. (RX 396 at 4). 

2546. Even assuming Eco Smartplastics included the ECM additive in the test PET plastic 

at an amount as high as 2%, a load rate higher than Eco SmartPlastics previously 

used, the mass of the sample would have been 0.5 grams. (Barlaz, Tr. 2251-54). 

2547. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from a 2% ECM additive (0.5 grams) tested in RX 396 is 466.5 mL of methane, 
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calculated by multiplying the weight of the ECM additive by Dr. Barlaz’s calculation 

of the mL of methane per gram of ECM additive (933 mL). (RX 968; Barlaz, Tr. 

2252-58). 

2548. At a net methane (CH4) yield of 1,675 mL, the biodegradation of the test plastic in 

RX 396 was more than three and on half (3.5x) times the amount of biodegradation 

that could have possibly been sourced from the ECM additive alone, all during the 

short forty five (45) day test window. (RX 396; RX 968; Barlaz, Tr. 2252-58). 

f. RX 395, NE Labs 1150851 (Sweet Tape Enterprise) Testing 

2549. In September 2011, NE Labs reported biodegradation test data from an anaerobic 

D5511 biodegradation test in laboratory reactors. (RX 395). 

2550. NE Labs performed the test on behalf of Sweet Tape Enterprise (M) Sdn. Bhd., in 

Malaysia. (RX 395 at 1). 

2551. RX 395 is an NE Labs analytical report of the type normally supplied by NE Labs. 

(RX 395; Johnson, Tr. 1571). 

2552. The test marked RX 395, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of an inoculum blank, a negative control (untreated plastic, here 

polyethylene), a positive control (cellulose), and a test sample, all of which were run 

in triplicate. (RX 395 at 1-2; Johnson, Tr. 1575). 

2553. The test marked RX 395 included a polypropylene (PP) clear tape plastic amended 

with the ECM additive. (RX 395 at 1; CCX 413). 

2554. The plastic test sample had an initial weight of 25 grams. (RX 395 at 1). 

2555. The test report (RX 395) does not specify the amount of ECM additive included in 

the test plastic. (RX 395). 

2556. NE Labs recorded data for the test marked RX 395 through 45 days. (RX 395 at 3). 

2557. In the test marked RX 395, NE Labs recorded biodegradation of the ECM amended 

PP sample in the amount of 4.54% after 45 days of anaerobic testing. (RX 395 at 3). 

g. RX 394, NE Labs 1150851 (Tycoplas Sdn. Bhd.) Testing

2558. In October 2011, NE Labs reported biodegradation test data from an anaerobic D5511 

biodegradation test in laboratory reactors. (RX 394). 

2559. NE Labs performed the test on behalf of Tycoplas Sdn Bhd. (RX 394 at 1). 
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2560. The test marked RX 394 is an NE Labs analytical report of the type normally 

supplied by NE Labs. (RX 394; Johnson, Tr. 1571). 

2561. The test marked RX 394, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of an inoculum blank, a negative control (untreated polyethylene), a 

positive control (cellulose), and a test sample, all of which were run in triplicate. (RX 

394 at 1; Johnson, Tr. 1575). 

2562. The test marked RX 394 included a plastic amended with the ECM additive. (RX 

394). 

2563. The plastic sample was labeled PS Foam Lunch Boxes with ECM Additive.” (RX 

394 at 1). 

2564. NE Labs recorded data for the test marked RX 394 through 15 days. (RX 394 at 3). 

2565. In the test marked RX 394, NE Labs recorded biodegradation of the ECM amended 

polystyrene sample in the amount of 5.89% after just 15 days of anaerobic testing. 

(RX 394 at 3). 

2566. Dr. Barlaz reviewed the raw data provided by NE Labs, including data pertaining to 

RX 394. (RX 394; RX 968; Barlaz, Tr. 2252-58). 

2567. For the test PS sample in RX 394, NE Labs reported 1,962 mL of total methane, 

compared to just 621 mL of methane in the inoculum blank. (RX 394 at 3; RX 472; 

RX 968). 

2568. The net methane yield between the inoculum and the test vessel in RX 394 was 

1,340.6 mL. (RX 394; RX 472; RX 968). 

2569. Dr. Barlaz calculated the mean substrate to inoculum ratio at 3.2 for this test (RX 

394), affirming that the methane content observed in the test vessels was from the test 

substrate (the plastic). (RX 394; RX 968; Barlaz, Tr. 2247-49, 2260-63). 

2570. Dr. Barlaz calculated methane and carbon dioxide t-statistics, and determined that the 

results of RX 394 were statistically significant. (RX 472; RX 968; Barlaz, Tr. 2259-

60). 

2571. The mass of the test sample in RX 394 was 25 grams. (RX 394 at 1). 

2572. The test report (RX 394) does not specify the load rate of the ECM additive in the test 

polystyrene product. (RX 394 at 3). 

2573. However, even assuming the additive was included at a 2% load rating, an amount 

higher than the 1.0-1.5% customers ordinarily use, the mass of the ECM additive 

would be 0.5 grams. (RX 394 at 3; RX 968; Barlaz, Tr. 2251-54). 
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2574. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from 0.5 grams of the ECM additive is 466.5 mL of methane, calculated by 

multiplying the weight of ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive (933 mL). (RX 968; Barlaz, Tr. 2252-58). 

2575. At a net methane (CH4) yield of 1,340.6 mL, the biodegradation of the test plastic in 

RX 394 was about three (3x) times the amount of biodegradation that could have 

possibly been sourced from the ECM additive alone. (RX 394; RX 968; Barlaz, Tr. 

2252-58). 

2576. Dr. Barlaz also calculated standard deviations for RX 394, which were within 

reasonable limits as expressed by the t-statistics. (RX 968; RX 472; Barlaz, Tr. 

2264). 

2577. Based in part on RX 394, Dr. Barlaz testified that the scientific evidence showed that 

plastic containing the ECM additive anaerobically biodegraded. (RX 968; Barlaz, Tr. 

2274). 

2578. The NE Labs Minigrips test (RX 838) demonstrated about 6% biodegradation based 

on methane conversion after 30 days of testing, before ultimately continuing to 

biodegrade to more than 17% after 365 days of testing. (RX 394 at 6 (6/13/2011 

Report)). 

2579. The NE Labs Tycoplas test (RX 394) exhibited nearly 6% biodegradation in roughly 

half the time, much of which could not have come from the ECM additive. (RX 394). 

h. RX 393, NE Labs 1253020 (National Tree Co.) Testing 

2580. In April 2012, NE Labs reported biodegradation test data from an anaerobic D5511 

biodegradation test in laboratory reactors. (RX 393). 

2581. NE Labs performed the test on behalf of National Tree Co. in Cranford, New Jersey. 

(RX 393 at 1). 

2582. RX 393 is an NE Labs analytical report of the type normally supplied by NE Labs. 

(RX 393; Johnson, Tr. 1571). 

2583. The test marked RX 393, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of inoculum blanks, negative controls (untreated plastic, PVC and 

PE), a positive control (cellulose), and two test samples, all of which were run in 

triplicate. (RX 393 at 1-2; Johnson, Tr. 1575). 

2584. The test marked RX 393 included two test samples amended with the ECM additive. 

(RX 393 at 1-2). 
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2585. One test sample was “PVC, Treated,” the other test sample was “PE, Treated.” (RX 

393 at 2). 

2586. Both test samples were 25 grams at the start of testing. (RX 393 at 2). 

2587. The negative controls involved untreated plastics, “PVC, Untreated” and “PE, 

Untreated.” (RX 393 at 2). 

2588. NE Labs recorded data for the test marked RX 393 through 15 days of anaerobic 

testing. (RX 393 at 4). 

2589. In RX 393, NE Labs recorded biodegradation of the ECM amended PVC sample in 

the amount of 9.89% after 15 days of anaerobic testing. (RX 393 at 4). 

2590. NE Labs recorded biodegradation of the ECM amended PE sample in the amount of 

5.75% after 15 days of anaerobic testing. (RX 393 at 4). 

2591. For the ECM amended PVC sample, NE Labs reported 1119 mL of total methane, 

compared to 254 mL of methane in the inoculum blank. (RX 393 at 4). 

2592. The net methane yield between the inoculum and the treated PVC sample in RX 393 

was therefore 865 mL. (RX 393 at 4). 

2593. For the amended PE sample, NE Labs reported 1451 mL of total methane, compared 

to 254 mL of methane in the inoculum blank. (RX 393 at 4). 

2594. The net methane production in the PE treated sample was therefore 1,197 mL of 

methane gas. (RX 393 at 4). 

2595. The negative controls for PVC and PE reported 238 mL and 219 mL of methane 

respectively, which is consistent with the 254 mL of methane produced in the 

inoculum blank. (RX 393 at 4). 

2596. The test report (RX 393) does not specify the amount of ECM additive included in 

the test plastic. (RX 393). 

2597. ECM recommends that its customers use close to 1% load rating. (CCX 10; Sinclair, 

Tr. 787-88). 

2598. Even assuming National Tree Co. included the ECM additive in the test plastics at an 

amount as high as 2%, a load rate higher than ECM recommended and higher than 

other customers ordinarily used, the mass of the additive in the samples would have 

been 0.5 grams. (Barlaz, Tr. 2251-54). 

2599. Based on Dr. Barlaz’s conservative calculations, the total theoretical yield of methane 

from 0.5 grams of the ECM additive is 466.5 mL of methane, calculated by 
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multiplying the weight of the ECM additive by Dr. Barlaz’s calculation of the mL of 

methane per gram of ECM additive (933 mL). (RX 968; Barlaz, Tr. 2252-58). 

2600. At a net methane (CH4) yield of 865 mL, the biodegradation of the treated PVC 

plastic in RX 393 was almost twice (2x) the amount of biodegradation that could have 

possibly been sourced from the ECM additive alone, all during the short fifteen (15) 

day test window. (RX 393; RX 968; Barlaz, Tr. 2252-58). 

2601. Similarly, at a net methane (CH4) yield of 1,197 mL, the biodegradation of the 

treated PE plastic sample in RX 393 was more than two and one half (2.5x) the 

amount of biodegradation that could have possibly been sourced from the ECM 

additive alone, all during the short fifteen (15) day test window. (RX 393; RX 968; 

Barlaz, Tr. 2252-58). 

i. RX 392, NE Labs 1048036 (Transilwrap Co.) Testing 

2602. In April 2011, NE Labs reported biodegradation test data from an anaerobic D5511 

biodegradation test in laboratory reactors. (RX 392). 

2603. NE Labs performed the test on behalf of Transilwrap Co. in Richmond, Indiana. (RX 

392 at 1). 

2604. RX 392 is an NE Labs analytical report of the type normally supplied by NE Labs. 

(RX 392; Johnson, Tr. 1571). 

2605. The test marked RX 392, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of inoculum blanks, negative controls (here polyethylene), a positive 

control (cellulose), and two test samples, all of which were run in triplicate. (RX 392 

at 1-2; Johnson, Tr. 1575). 

2606. The test marked RX 392 included two test samples amended with the ECM additive. 

(RX 392 at 1-2). 

2607. One test sample was a Thin HIPS (High Impact Polystyrene) Based Sheet, the other 

test sample was a “Two Layer Laminating Film.” (RX 392 at 1; CCX 273). 

2608. Both test samples were 25 grams at the start of testing. (RX 392 at 1). 

2609. Transilwrap described the samples as a “HIPS sheet allow with the ECM additive, 

and a thin film PETG coated with EVA (also both having [the ECM] additive).” 

(CCX 273 at 3). 

2610. NE Labs recorded data for the test marked RX 392 through 233 days of anaerobic 

testing. (RX 392 at 4). 
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2611. In RX 392, NE Labs recorded biodegradation of the ECM amended HIPS polystyrene 

sample in the amount of 7.85% after 233 days of anaerobic testing. (RX 392 at 4). 

2612. NE Labs recorded biodegradation of the ECM amended Two Layer Laminating Film 

sample in the amount of 8.53% after 233 days of anaerobic testing. (RX 392 at 4). 

2613. The test report (RX 392) does not specify the amount of ECM additive included in 

the test plastic. (RX 392). 

2614. ECM recommends that its customers use close to 1% load rating. (CCX 10; Sinclair, 

Tr. 787-88). 

j. RX 399, NE Labs N0843980 (Bio-Tec Environmental, LLC) 

Testing 

2615. In December 2008, NE Labs reported biodegradation test data from an anaerobic 

D5511 biodegradation test in laboratory reactors. (RX 399). 

2616. NE Labs performed the test on behalf of Bio-Tec Environmental, LLC in 

Albuquerque, New Mexico. (RX 399 at 1). 

2617. RX 399 is an NE Labs analytical report similar to the type ordinarily supplied by NE 

Labs. (RX 399; Johnson, Tr. 1571). 

2618. The test marked RX 399, as with other NE Labs ASTM D5511 biodegradation tests, 

included the use of an inoculum blank (called “sludge control”), a negative control, a 

positive control (cellulose), and a test sample, all of which were run in triplicate. (RX 

399 at 1-2; Johnson, Tr. 1575). 

2619. The test marked RX 399 included a polypropylene plastic sheet amended with the 

ECM additive. (RX 399 at 1; CCX 413). 

2620. The plastic test sample had an initial weight of 100 grams. (RX 399 at 1). 

2621. The test report (RX 399) does not specify the amount of ECM additive included in 

the test plastic. (RX 399). 

2622. ECM recommends that its customers use just above a 1% load rating. (CCX 10; 

Sinclair, Tr. 787-88). 

2623. NE Labs recorded data for the test marked RX 399 through 14 days. (RX 399 at 2). 

2624. In RX 399, one of the earlier NE Labs biodegradation tests, NE Labs used two 

endpoints to assess biodegradation, methane gas conversion and gravimetric weight 

loss. (RX 399 at 2). 
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2625. Although gas data was not available, NE Labs concluded in RX 399 that, based on 

the average weight loss of the triplicate test samples and the methane gas conversion, 

the “results indicate[d] that the treated PP Sheets was biodegradable.” (RX 399 at 2). 

3. Other Anaerobic Gas Evolution Testing 

a. CCX 952, NC State 2010 StarchTech BMP Testing 

2626. In March 2010, Dr. Barlaz reported his results from a biochemical methane potential 

(BMP) test involving recycled polystyrene loosefill peanuts with the ECM additive. 

(CCX 952 at 1). 

2627. The test was on behalf of StarchTech. (CCX 952). 

2628. Dr. Barlaz performed his BMP test as he did other BMP tests performed at his NC 

State laboratory. (Barlaz, Tr. 2220-22, 2269-72). 

2629. In the test memorialized as CCX 952, Dr. Barlaz tested two materials, a recycled 

polystyrene loosefill plastic with the ECM additive, and a starch-based biodegradable 

loosefill product. (Barlaz, Tr. 2270). 

2630. Dr. Barlaz’s results showed significant methane generation that was attributed to the 

test substrate, to wit, the plastic. (Barlaz, Tr. 2270; CCX 952). 

2631. Dr. Barlaz calculated the percent that each material was converted to methane, 

subtracting the methane produced from the inoculum blanks. (Barlaz, Tr. 2270-71; 

CCX 952). 

2632. Dr. Barlaz calculated the percentage of biodegradation by examining the percent loss 

of volatile solids, which was 7.4% of the ECM-amended polystyrene loosefill product 

in 60 days. (CCX 952; Barlaz, Tr. 2271). 

2633. Although Dr. Barlaz terminated his BMP test on day 60, he observed that the short 

term, laboratory scale biodegradation test was not an accurate representation of the 

biodegradation potential of the sample. (Barlaz, Tr. 2271-74). 

2634. Dr. Barlaz’s test report included methane production data at day 30 and day 60. 

(CCX 952 at 2). 

2635. Dr. Barlaz explained that “the methane generation on day 60 is double that of the 

methane generation on day 30, so there – the implication is that the measured 

methane is a lower limit and more methane would have been produced had we run the 

test for longer than 60 days.” (Barlaz, Tr. 2271). 
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2636. The fact that methane generated during days 31-60 was equal to or more than 

methane generated on days 1-30 was scientifically significant because it demonstrates 

that the test sample was likely to evidence more biodegradation than the 60-day BMP 

test would suggest. (Barlaz, Tr. 2271-72). 

2637. According to Dr. Barlaz, there was “no evidence that methane generation is slowing 

down, whereas, if you look at the second material [Starch-based product] there’s 

considerable evidence that methane generation is slowing down.” (Barlaz, Tr. 2271-

72). 

2638. Dr. Barlaz has concluded that this observed phenomena “speaks to the BMP as I’ve 

been using it with cutting it off at 60 days is perhaps imperfect or not appropriate if I 

have a slowly degradable substrate.” (Barlaz, Tr. 2272). 

b. RX 265, OWS Microtech Research Inc. Anaerobic 

Testing (Feb 1999) 

2639. In February 1999, O.W.S. Inc. reported the results of anaerobic testing on the ECM 

additive pellets. (RX 265 at 6). 

2640. OWS performed the test titled “High Solids Anaerobic Digestion (HSAD) Test of 

ECM pellets,” on behalf of Patrick F. Riley of Microtech Research. (RX 265). 

2641. The OWS test marked RX 265 was performed under the ASTM D5511-94 method. 

(RX 265). 

2642. The substance tested were the ECM pellets by themselves. (RX 265). 

2643. At the time, in 1999, the ECM pellets were comprised of approximately 50% active 

biodegradable components, and 50% of a traditionally non-biodegradable “carrier” 

resin. (CCX 818 (Sinclair, Dep. at 116)). 

2644. ECM would later change its “load rating” to a 70% load of the actively biodegradable 

components. (CCX 818 (Sinclair, Dep. at 118-20)). 

2645. OWS, like Eden Laboratories and Northeast Labs, measured total gas volume using a 

graduated cylinder. (RX 265 at 8). 

2646. The OWS RX 265 test was conducted at a 34.1% solids content (63.9% moisture). 

(RX 265 at 12). 

2647. After 15 days, the ECM pellets anaerobically biodegraded 24%. (RX 265 at 17). 

2648. The test was terminated after 15 days. (RX 265). 

c. RX 268, OWS Covidien Anaerobic Testing (May 2010) 
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2649. In May 2010, O.W.S. Inc. reported the results of anaerobic testing on polypropylene 

(PP) product labeled “polypropylene plaques.” (RX 268 at 6). 

2650. OWS performed the test titled “High Solids Anaerobic Digestion (HSAD) Test,” on 

behalf of Covidien in Mansfield, MA. (RX 268 at 1). 

2651. The OWS test marked RX 268 was performed under the ASTM D5511-02 method. 

(RX 268 at 3). 

2652. In the OWS test marked RX 268, the positive control, cellulose, reached a plateau at 

69.5%. (RX 268 at 4). 

2653. The failure to achieve 70% biodegradation in the positive control is an indication that 

the test environment was not suitable for biodegradation testing. (RX 356 at 3 § 

11.2.1.1). 

2654. The OWS test marked RX 268 revealed 3.9% biodegradation of the test sample in 15 

days of anaerobic degradation. (RX 268 at 7). 

2655. The test indicated that the sample vessels plateaued around the same time as the 

cellulose vessels plateaued at 69.5%. (RX 268 at 5-7). 

2656. In another OWS test in 1999 (RX 265), OWS wrote that cellulose should biodegrade 

at least to 85% through gas evolution, while at most 15% of the cellulose can be 

assimilated by microorganisms or left as other byproduct. (RX 265 at 16-17). 

2657. In the NE Labs Minigrips test (RX 838), 3.65% biodegradation of the test samples 

were observed after 15 days of D5511 anaerobic testing. (RX 838 at 3). 

2658. The 3.9% biodegradation observed in the OWS RX 268 test, before the entire system 

plateaued, is consistent with the test data observed after 15 days in RX 838. (RX 838 

at 3; RX 265 at 7). 

2659. The NE Labs Minigrips test (RX 838) reflected more than 17% biodegradation of the 

test sample after one year of sustained testing, based on gas conversion. (RX 838). 

C. Qualitative Testing 

2660. Qualitative testing is part of the totality of the scientific evidence in the case. (Sahu, 

Tr. 1910). 

2661. The qualitative studies provide multiple lines of proof. (Sahu, Tr. 1910-11). 

2662. In the Environ BioPVC study, the measurement of free chloride ions was a significant 

element. (Sahu, Tr. 1912-13). 
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2663. In the Environ test marked RX 254, Dr. Barber observed that the presence of chlorine 

atoms in solution had increased along with biodegradation of the polyvinyl chloride 

(PVC) substrate. (Sahu, Tr. 1912-13; RX 254). 

2664. The molecular weight of the PVC is due to the molecular weight of chlorine, which is 

heavy. (Sahu, Tr. 1912). 

2665. If the PVC molecule loses chloride, there would be an alteration of the chemical 

structure of PVC that indicates the carbon backbone will also degrade. (Sahu, Tr. 

1912-13). 

2666. Hydrogen chloride (HCl) is actually the group that is lost due to degradation. (Sahu, 

Tr. 1913). 

2667. If the molecule loses the HCl, the underlying carbon backbone is unavoidably altered 

too. (Sahu, Tr. 1913). 

2668. Double bonds are formed in the carbon backbones that are unavoidably reformed 

when the HCl group drops out. (Sahu, Tr. 1914). 

2669. Dr. Barber concluded in his published reports that the ECM additive would render 

plastics such as PVC fully degradable with a 1.9 year half-life. (RX 254 at 1). 

2670. He confirmed his gravimetric endpoints by looking at free chloride content in the test 

solution, noting that the chloride ions would have come from the degraded sections of 

the PVC plastic and that “an increase in soil leachate chloride content and reduction 

in tensile strength was observed, indicat[ing] the PVC molecules were being 

effectively degraded.” (RX 370 at 6; RX 259). 

2671. Dr. Barber also reviewed test data from other laboratories concerning ECM’s additive 

technology. (RX 269). 

2672. Dr. Barber had explained that ASTM protocols that are available are inappropriate for 

to test slowly degrading material and, so, he had to create his own test model. 

(Barber, Tr. 2062:8-9). 

2673. Conventional plastics are challenging materials that may take many years to 

biodegrade. (Barber, Tr. 2057:5-6). 

2674. ASTM did not conceive of this type of material when they were developing their 

standards, and these materials must be tested for longer periods of time. (Barber, Tr. 

2062:9-11). 

2675. Therefore, an in-house method of testing with similar reliability safeguards to ASTM 

(i.e., positive and negative control, and a significant level of replication and statistical 

testing) must be developed for these materials. (Barber, Tr. 2062:12-2063:3). 
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2676. Dr. Barber testified that to see if a slowly degrading material fully biodegrades in a 

lab, you would have to run a test for ten, fifteen, or twenty years. (Barber, Tr. 2057:7-

11). 

2677. Running a test for ten to twenty-five years would be very expensive. (Barber, Tr. 

2058:3-4). 

2678. In some cases, testing requires daily monitoring or interaction with the sample, and 

doing this for tens of years would be prohibitively expensive. (Barber, Tr. 2058:4-8). 

2679. A bigger issue with running tests of this duration is maintaining a viable culture for 

such a long period of time. (Barber, Tr. 2058:9-11). 

2680. Maintaining a viable culture requires monitoring of temperature, water, pH, and 

nutrients for ten or more years would be extremely difficult. (Barber, Tr. 2058:17-23). 

2681. Dr. Barber found it very difficult to maintain a real active biological system longer 

than twelve to eighteen months, and the concept of maintaining this level of activity 

for tens of years in a laboratory is next to impossible. (Barber, Tr. 2059:5-9). 

2682. Therefore, a test must be run for a discrete, reasonable period of time. (Barber, Tr. 

2057:12-13). 

2683. The tester must ensure that that the amount of material that has been biodegraded is 

much higher than the amount of additive to show that it isn’t just the additive that is 

biodegrading. (Barber, Tr. 2057:13-16). 

2684. This would indicate that the microbes are attacking the base polymer, and there would 

be no reason to believe this would not continue until the base material is completely 

biodegraded. (Barber, Tr. 2057:16-20). 

2685. Dr. Barber was convinced based on the test results that ECM’s technology produced a 

biodegradable plastic. (RX 870 (Barber, Dep. at 90)). 

2686. Dr. Barber has performed tests for five or six ECM customers concerning the 

biodegradability of ECM plastics that they manufacture. (Barber, Tr. 2028). 

2687. Dr. Barber had to create a testing methodology similar to the ASTM testing protocols 

but on a timescale more appropriate for conventional plastics testing (9 to 18 months) 

and using slightly different leachate. (Barber, Tr. 2030–31, 2034). 

2688. Dr. Barber’s tests were designed to simulate landfill conditions as closely as possible. 

(Barber, Tr. 2034, 2044–45). 

2689. Dr. Barber’s tests use special containers to maintain anaerobic conditions, and pH, 

temperature, and moisture content were monitored to maintain optimal levels. 

(Barber, Tr. 2037–39). 
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2690. Dr. Barber’s tests, like ASTM protocols, utilized both positive and negative controls. 

(Barber, Tr. 2036). 

2691. Dr. Barber performed testing for FP International to determine the biodegradability of 

their plastics when infused with the ECM additive under both aerobic and anaerobic 

conditions. (Barber, Tr. 2034. 2041, 2051, 2065, 2148). 

2692. The FP International Report summarized the findings of Dr. Barber’s tests, stating 

that ECM plastic “is biodegradable under laboratory conditions that simulate 

conditions expected to occur in a composting operation or in a municipal landfill 

managed to promote biological activity.” (Barber, Tr. 2047–48; RX 275). 

2693. Dr. Barber performed weight-loss testing for BioPVC to determine the 

biodegradability of their plastics when infused with the ECM additive under 

anaerobic conditions. (Barber, Tr. 2048–49; RX 120). 

2694. Dr. Barber’s testing showed weight loss of the ECM material, but not the negative 

control, indicating that the ECM material was biodegrading. (Barber, Tr. 2055; RX 

120). 

2695. Dr. Barber also had tensile strength and free chloride testing done on the material 

after nine months in a simulated landfill environment. (Barber, Tr. 2053–55). 

2696. Dr. Barber’s testing showed reduced tensile strength as compared to the negative 

control, indicating that the material was biodegrading. (Barber, Tr. 2055). 

2697. Dr. Barber’s testing also showed a higher free chloride concentration as compared to 

the negative control, indicating the breaking of covalent bonds by organic processes. 

(Barber, Tr. 2056). 

2698. Dr. Barber drafted a report summarizing the findings of his tests. (2049; RX 254). 

2699. Dr. Barber also provided analytical consulting for BIOtech Products, LLC, an ECM 

customer, of their test data on the biodegradability of the ECM infused plastics they 

produce. (Barber, Tr. 2056–57). 

2700. Dr. Barber stated in an email to BIOtech Products, LLC explaining his conclusions: 

After a significant level of biodegradation, five to ten times 

the level of the additive, the only reasonable assumption, 

assuming conditions supportive of biological activity 

continue, is that all of the base polymer will biodegrade. 

(Barber, Tr. 2056–57; RX 426). 
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218 

2701. Dr. Barber was contacted by Bill Walters of QC Product Development, an ECM 

customer, and asked to determine whether their polyethylene product infused with the 

ECM additive would biodegrade. (Barber, Tr. 2064–65; RX 430). 

2702. Dr. Barber, based on his findings for FP International and their polyethylene product, 

informed Mr. Walters that “PE film with ECM additive is biodegradable.” (Barber, 

Tr. 2065; RX 430). 

2703. ECM employees, including Mr. Sinclair, also performed tests of the ECM additive in 

gardens, backyard soils, and in 50-gallon drums to assess biodegradation in real-time. 

(CCX 818 (Sinclair, Dep. at 63-69); CCX 820 (Sullivan, Dep. at 8-9); Sullivan, Tr. 

725–728; Sinclair, Tr. 755–56). 

2704. Environ had also demonstrated through testing similar to the BioPVC work that 

polyethylene amended with a 1% ECM additive was biodegradable. (RX 275). 

2705. ECM also received microscopy with images that reflected changes to plastic and 

biodegradation after plastic articles had been exposed to test environments. (RX 254; 

RX 269; RX 270; RX 271). 

2706. Other companies and customers have similarly applied qualitative endpoints to verify 

that plastics made with the ECM additive had biodegraded. (RX 274; 277; RX 388-

91). 

XVII. DR. TOLAYMAT’S OPINIONS ARE NOT CREDIBLE 

2707. In drafting his expert opinion in this case, Complaint Counsel’s witness Dr. Tolaymat 

rejected dozens of scientific tests (including gas evolution tests) because he deemed 

them to be unreliable or methodologically flawed. (Tolaymat, Tr. 296; CCX 893 at 

39-46). 

2708. Dr. Tolaymat is an employee of the EPA, a sister agency of the FTC. (Tolaymat, Tr. 

216-17). 

2709. Dr. Tolaymat was paid an EPA salary for the work he performed in this case. 

(Tolaymat, Tr. 118-19, 215-16). 

2710. He worked on this case during regular business hours, from his EPA office. 

(Tolaymat Tr. 215-16). 

2711. Despite working on the case as an EPA employee, Dr. Tolaymat did not share his 

report or opinions with any other EPA employee or official before submitting them in 

this case. (Tolaymat, Tr. 216). 
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219 

2712. Dr. Tolaymat did not consult any other colleagues or persons at the EPA concerning 

his opinions in this case. (Tolaymat, Tr. 216-17). 

2713. The EPA has other individuals in their ranks that are considered landfill gas experts. 

(Tolaymat, Tr. 217). 

2714. One of those persons is Susan Thorneloe in the EPA’s Officer of Research and 

Development, who has more than 25 years of experience with landfills and landfill 

gas. (Tolaymat, Tr. 217). 

2715. Dr. Tolaymat has been with the EPA for eleven years. (Tolaymat, Tr. 217). 

2716. Dr. Tolaymat did not share his opinions in this case with Susan Thorneloe, or anyone 

at the EPA’s ORD, to determine whether his position was consistent with theirs or 

scientifically reasonable. (Tolaymat, Tr. 217). 

2717. Dr. Tolaymat was retained by Complaint Counsel as early as 2010 to assist with this 

case. (Tolaymat, Tr. 214). 

2718. From 2010 through the time when he testified at deposition, Dr. Tolaymat had 

performed just 80 hours of work on this case total. (Tolaymat, Tr. 214). 

2719. Most of his 80 hours were spent drafting his expert report. (Tolaymat, Tr. 214). 

2720. Dr. Tolaymat did not perform significant research into plastics before preparing his 

expert opinion. (Tolaymat, Tr. 214). 

2721. Although he had recommended to Complaint Counsel that they perform BMP testing 

on ECM plastics, Dr. Tolaymat did not test the Plastic containing the ECM additive 

or plastics made with same. (Tolaymat, Tr. 356, 214). 

2722. Dr. Tolaymat was unable to specifically identify what type of tests or testing would 

be considered competent and reliable evidence to show biodegradation in landfills. 

(Tolaymat, Tr. 218). 

2723. Dr. Tolaymat proposed an in-situ landfill study (Tolaymat, Tr. 218), which Dr. Barlaz 

later explained is impractical and erroneous. (Barlaz, Tr. 2237). 

2724. Dr. Tolaymat recognizes Dr. Barlaz as an authority in the field. (Tolaymat, Tr. 233). 

2725. Dr. Tolaymat has consulted Dr. Barlaz on a number of questions concerning landfill 

biodegradation, and Dr. Barlaz has been hired by the EPA as a consultant on 

biodegradation. (Tolaymat, Tr. 233). 

2726. Dr. Tolaymat has asked Dr. Barlaz to comment and review on Tolaymat’s work. 

(Tolaymat, Tr. 234). 

2727. Dr. Tolaymat has asked Dr. Barlaz to revise his work. (Tolaymat, Tr. 234). 
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220 

2728. No other expert in the case suggested that an in situ landfill study was required to 

show biodegradation. (Tr. 1-3005). 

2729. Dr. Tolaymat admitted that his proposal to use in situ landfill studies to measure 

biodegradation would not be appropriate because researchers would not be able to 

quantify or determine a specific amount of biodegradation. (Tolaymat, Tr. 222). 

2730. Dr. Tolaymat later testified that, in his proposed in situ landfill study, “weight loss” 

would be an appropriate measurement of biodegradation, because gas evolution data 

would not be possible. (Tolaymat, Tr. 224). 

2731. However, when attacking studies favorable to ECM, like the Environ tests, just hours 

before testifying on cross, Dr. Tolaymat was convinced that “mass loss as an 

indicator for biodegradation” was not appropriate. (Tolaymat, Tr. 183-84). 

2732. In fact, one of Dr. Tolaymat’s principle reasons for rejecting the Environ testing was 

because the study relied on mass loss as an indicator of biodegradation. (Tolaymat, 

Tr. 182-84). 

2733. Dr. Tolaymat had never encountered an in situ landfill experiment that tested a 

specific commercial product as opposed to waste generally. (Tolaymat, Tr. 224). 

2734. Dr. Tolaymat had never heard of any company specifically performing an in situ

study for purposes of evaluating biodegradation claims. (Tolaymat, Tr. 224-25). 

2735. Dr. Tolaymat admitted that in situ studies carry substantial difficulties and risks that 

complicate the ability to perform a successful test. (Tolaymat, Tr. 225-26). 

2736. Dr. Tolaymat testified that landfill in situ studies are “rarely” performed. (Tolaymat, 

Tr. 237). 

2737. Dr. Tolaymat also testified that lysimeter studies are possible. (Tolaymat, Tr. 228-

29). 

2738. Dr. Tolaymat stated that, to perform an adequate lysimeter study, he would make 12 

percent of the lysimeter composed of ECM amended plastics. (Tolaymat, Tr. 229). 

2739. Dr. Tolaymat could not explain how a lysimeter test composed of fully twelve percent 

ECM plastic would be representative of the typical landfill environment, particularly 

after he testified that plastics generally (not just ECM) ordinarily comprise twelve 

percent of the total waste. (Tolaymat, Tr. 229). 

2740. Dr. Tolaymat’s proposed lysimeter study would not rely on gas evolution data, but 

rather a series of qualitative endpoints like leachate quality and quantity. (Tolaymat, 

Tr. 230). 
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221 

2741. Dr. Tolaymat did not explain how, if at all, he could calculate the percentage of 

biodegradation in a landfill based on those endpoints he posited for the lysimeter 

study. (Tolaymat, Tr. 230). 

2742. In fact, although Dr. Tolaymat rejected entirely the Environ BioPVC study (and 

similar Environ studies) because Environ relied on weight loss as an endpoint, Dr. 

Tolaymat himself suggested that weight loss was an acceptable measurement when 

used in his in situ landfill studies. (Tolaymat, Tr. 279-80). 

2743. He testified that weight loss was an appropriate endpoint for in situ studies, but not 

for the Environ study, even though he agreed that for the in situ landfill studies there 

are more variables as far as possible confounders than in the laboratory test 

performed by Dr. Barber at Environ. (Tolaymat, Tr. 281). 

2744. In fact, Dr. Tolaymat testified that there are more concerns with “things that could go 

wrong” in an in situ landfill study than there would be in the Environ BioPVC study, 

which Dr. Tolaymat rejected outright. (Tolaymat, Tr. 281). 

2745. Without supporting data, Dr. Tolaymat testified that he could use mass loss endpoints 

for an in situ study, but not for a laboratory study. (Tolaymat, Tr. 282). 

2746. When specifically asked about what type of competent and reliable scientific 

evidence would be appropriate to prove that a product biodegrades at a certain rate in 

a landfill, Dr. Tolaymat explained that he would accept a “combination of tests.” 

(Tolaymat, Tr. 262). 

2747. He explained that, under the totality of scientific evidence, whether a biodegradation 

claim was supported was entirely a matter of scientific judgment. (Tolaymat, Tr. 

262). 

2748. Dr. Tolaymat has himself relied on less than perfect scientific data in his research. 

(Tolaymat, Tr. 262). 

2749. The EPA has guidance documents addressing how to glean information from less 

than perfect scientific information. (Tolaymat, Tr. 262-63). 

2750. Dr. Tolaymat did not consult the EPA’s guidance documents concerning data 

validation and verification before authoring his report. (Tolaymat, Tr. 262-63). 

2751. When specifically asked about what type of competent and reliable scientific 

evidence would be appropriate to prove that a product biodegrades at a certain rate in 

a landfill, Dr. Tolaymat explained that “one of the tests would be the biochemical 

methane potential test” or BMP. (Tolaymat, Tr. 218-19). 

2752. The BMP test is a gas evolution test performed in a laboratory. (Tolaymat, Tr. 219). 

2753. Dr. Tolaymat attempted to describe in vague terms how he would calculate a rate of 

biodegradation in an MSW landfill using a BMP test. (Tolaymat, Tr. 220-21). 
 PUBLIC DOCUMENT 

222 

2754. Dr. Tolaymat acknowledged that the rate of degradation would be “slower” in a 

landfill than in a BMP test. (Tolaymat, Tr. 221). 

2755. When asked how he could then determine the specific rate of biodegradation in the 

landfill from the BMP, in other words, how much slower the degradation would be, 

Dr. Tolaymat testified that he “would be speculating if I tell you.” (Tolaymat, Tr. 

221). 

2756. The BMP test does not “replicate or simulate” landfill conditions, as Dr. Tolaymat 

uses that phrase, because it does not have the same moisture content as many 

landfills, it is usually conducted at higher temperatures, the test is enriched with 

nutrients, and the test samples are often ground or passed through screens. 

(Tolaymat, Tr. 220, 237-38). 

2757. Dr. Tolaymat specifically testified that the BMP test “does not simulate” a landfill, 

and that the environment is optimized to show biodegradation. (Tolaymat, Tr. 237-

38). 

2758. Dr. Tolaymat testified that the BMP differs “dramatically” from the typical U.S. 

landfill. (Tolaymat, Tr. 238). 

2759. Dr. Tolaymat still testified that “the BMP test provides [competent and reliable] data 

to shed light on the degradation in a landfill.” (Tolaymat, Tr. 218). 

2760. He explained that, “if you run the appropriate controls, yes, the BMP could be a 

suitable test.” (Tolaymat, Tr. 237-38). 

2761. Dr. Tolaymat recommended to Complaint Counsel that they perform a BMP test to 

assess the biodegradability of plastics made with the ECM additive. (Tolaymat, Tr. 

356-57). 

2762. At hearing, Dr. Tolaymat deviated from prior testimony and testified that he could not 

have tested the ECM additive because of hardship. (Tolaymat, Tr. 353-54). 

2763. Contrary to his hearing testimony, Dr. Tolaymat testified at deposition that he offered 

to perform product testing of the ECM plastics for Complaint Counsel. (RX 851 

(Tolaymat, Dep. at 39)). 

2764. Specifically, Dr. Tolaymat testified as follows: 

Q: Do you have the capability of performing product testing of ECM’s 

products? 

A: Yes. 

Q: You could run any of the tests that you did that you cite to in the peerreviewed literature, right? 

A: Given enough time, we have the capability to run any tests we deem 

necessary. 

... 
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223 

Q: Did you ask to perform any of those tests? 

A: I suggested one time that it may be beneficial to do it, but that was it. 

... 

Q: What kind of test did you suggest? 

A: Whatever anaerobic tests we were conducting at the time, so it probably 

would be the biochemical methane potential test. 

(RX 851 (Tolaymat, Dep. at 38-39). 

2765. Then, at the hearing, Dr. Tolaymat testified contrary to his deposition that EPA could 

not have performed testing because they “would have to open it up for any other 

company out there that has a product that they claim is biodegradable.” (Tolaymat, 

Tr. 353). 

2766. Dr. Tolaymat conceded that the test protocol for a BMP test is not standardized and it 

varies considerably from one laboratory to another. (Tolaymat, Tr. 239). 

2767. Dr. Tolaymat stated that the deviation from one laboratory to another in the operation 

of the BMP study did not render data unreliable. (Tolaymat, Tr. 239). 

2768. Dr. Tolaymat himself chose to perform a BMP test to evaluate the biodegradability of 

commercial plastic products in about 2010. (Tolaymat, Tr. 238-39). 

2769. The point of Dr. Tolaymat’s BMP study was specifically to draw conclusions about 

“the performance of the plastics in a landfill environment.” (Tolaymat, Tr. 243). 

2770. At the same time, Dr. Tolaymat rejected “dozens” of favorable ECM D5511 gas 

evolution studies because, according to Dr. Tolaymat, they did not “simulate” landfill 

conditions. (Tolaymat, Tr. 235-37). 

2771. He testified that he rejected “all of ... ECM’s D5511 studies because they don’t 

simulate the landfill environment.” (Tolaymat, Tr. 243). 

2772. But Dr. Tolaymat himself relied on that same type of scientific information in his 

own assessments of plastics biodegradability in landfills. (Tolaymat, Tr. 243). 

2773. Despite that fact, Dr. Tolaymat testified that a test which deviates in any respect from 

a landfill environment through, e.g., temperature or moisture, is not competent and 

reliable scientific evidence to show that a product will biodegrade in a typical 

municipal solid waste landfill. (Tolaymat, Tr. 236-37). 

2774. Dr. Tolaymat agreed that biodegradation tests can be accelerated, but he did not know 

and would have needed to “speculate” how a researcher would accelerate the tests. 

(Tolaymat, Tr. 244). 

2775. Dr. Tolaymat was not sure whether a plastic that biodegraded in a landfill in twenty 

years was environmentally beneficial. (Tolaymat, Tr. 245-46). 
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224 

2776. In his expert report, Dr. Tolaymat did not understand how half-lives operate, and he 

repeatedly calculated the time for complete biodegradation of a material to be simply 

twice the half-life. (CCX 893 at 16 n.9, 27 ¶67). 

2777. He later corrected himself at the hearing after being confronted with his erroneous 

understanding of half-lives during his deposition. (RX 851 (Tolaymat, Dep. at 97-

99); Tolaymat, Tr. 246-47). 

2778. Based on Dr. Tolaymat’s insistence that a test must replicate or simulate a landfill 

environment, Dr. Tolaymat admitted that, to satisfy his standard, a test would need to 

be run for decades in order to show that a degradable plastic, which could reasonably 

biodegrade over 20 years, was completely biodegraded. (Tolaymat, Tr. 245-50). 

2779. Dr. Tolaymat testified that a test must precisely simulate the landfill environment to 

be competent and reliable, but, he also accepted that a biodegradation test could be 

“accelerated” so that it would not be required to run for decades. (Tolaymat, Tr. 

249). 

2780. When asked how tests could be accelerated while at the same time simulating a 

landfill environment, Dr. Tolaymat stated, “that is an open-ended question. I mean, 

we can spend hours and hours talking about it” and “it’s going to take more than this 

court has time to allow.” (Tolaymat, Tr. 250). 

2781. Dr. Tolaymat testified that the D5511 test is not an “accelerated” test. (Tolaymat, Tr. 

250-51). 

2782. He testified that a laboratory could conduct a D5511 test for several years while 

maintaining test conditions. (Tolaymat, Tr. 251). 

2783. However, Dr. Tolaymat rejected certain ECM D5511 tests that were longer in 

duration because, according to Dr. Tolaymat, they did not follow the D5511 method 

precisely. (Tolaymat, Tr. 251-52). 

2784. Dr. Tolaymat offered no explanation for why a D5511 test of longer duration would 

not follow the D5511 method. (Tolaymat, Tr. 250-53). 

2785. The ASTM D5511 method does not specify a cutoff time or duration for the test and, 

in fact, the method specifically contemplates tests of varying durations: “The 

incubation time shall be run until no net gas production is noted for at least five days 

from both the positive control and the test substance reactors.” (RX 356 at 3 § 

11.2.1.2) (emphasis added). 

2786. Although Dr. Tolaymat entirely rejected ECM D5511 tests that were run longer than 

60 days because those tests did not “follow the standard test method,” he offered no 

scientific basis to reject data on those grounds alone, and he acknowledged that the 

BMP test, upon which he himself used and recommended, did not even have a 

standard test method. (Tolaymat, Tr. 252-54). 
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225 

2787. Dr. Tolaymat admitted that he excluded “an entire class of studies” solely because 

they did not “simulate the landfill” and that he excluded those studies “regardless of 

how well-conducted those studies [were].” (Tolaymat, Tr. 296) (emphasis added). 

2788. On that basis, he rejected “dozens” of positive ECM studies. (Tolaymat, Tr. 296). 

2789. Dr. Tolaymat performed no research and reviewed no studies or articles concerning 

the limitations of closed-system laboratories. (Tolaymat, Tr. 290). 

2790. He reviewed no articles or literature on the principle of feedback inhibition. 

(Tolaymat, Tr. 290). 

2791. Dr. Sahu, by contrast, testified that extending the duration of a D5511 test does not 

render the data unreliable. (Sahu, Tr. 1928). 

2792. Dr. Sahu testified that, consistent with the D5511 standard itself, as long as the 

conditions of the test are maintained, then there is no reason to simply reject a test 

based on an increase in study duration. (Sahu, Tr. 1928). 

2793. Dr. Sahu had no concerns with the methodology of the various laboratory reactor tests 

performed on ECM plastics. (Sahu, Tr. 1932-33). 

2794. In his expert report, Dr. Tolaymat wrote that the conditions in a D5511 gas evolution 

test will cause activity by “different bacterial communities” in landfills. (Tolaymat, 

Tr. 263). 

2795. Dr. Tolaymat presented no data in his report or testimony concerning an assessment 

of bacterial communities in landfills. (Tolaymat, Tr. 264). 

2796. Dr. Tolaymat does not consider himself to be an expert in the kinds of microbial 

species that exist in landfills. (Tolaymat, Tr. 264). 

2797. Dr. Tolaymat was not aware of the type of enzymes produced by microbial species 

that might cause biodegradation. (Tolaymat, Tr. 264). 

2798. Dr. Tolaymat could not identify or explain the mechanisms of action used by 

microbes and colonies of microbes to biodegrade plastics. (Tolaymat, Tr. 264). 

2799. Dr. Tolaymat did not know whether there is an overlap in the temperatures where 

mesophilic and thermophilic bacteria function. (Tolaymat, Tr. 266). 

2800. Dr. Tolaymat did not evaluate whether thermophilic and mesophilic bacteria would 

use similar forms of enzymatic degradation or metabolism to break down substrates. 

(Tolaymat, Tr. 266). 

2801. Dr. Tolaymat could not name a single phyla of bacteria that exist in landfills. 

(Tolaymat, Tr. 266). 
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226 

2802. Dr. Tolaymat could not name a single phyla of fungi that exist in landfills. 

(Tolaymat, Tr. 266). 

2803. Dr. Tolaymat could not state whether types of bacteria in a D5511 test environment 

also exist in the MSW landfills. (Tolaymat, Tr. 266-67). 

2804. Dr. Tolaymat rejected the Environ BioPVC study (CCX 739) because, according to 

him, it contained several methodological flaws. (Tolaymat, Tr. 268-69). 

2805. He rejected the study (CCX 739) because the moisture content was too high. 

(Tolaymat, Tr. 268-69). 

2806. However, Dr. Tolaymat himself had relied on BMP studies that had higher moisture 

levels than the Environ BioPVC study, and Dr. Tolaymat testified that those BMP 

studies were competent and reliable. (Tolaymat, Tr. 218-19, 268-69). 

2807. Dr. Tolaymat also conceded that landfill systems are highly variable and have many 

different moisture levels throughout a single landfill, including pockets were waste is 

saturated. (Tolaymat, Tr. 270-71). 

2808. Dr. Tolaymat conceded that landfills have “ponding” or ponded areas where water 

content is saturated above the fifty percent (50%) mark. (Tolaymat, Tr. 273-74). 

2809. He admitted that a landfill could be almost dry on one side and then very wet on the 

other side. (Tolaymat, Tr. 274-75). 

2810. He also conceded that landfills receive moisture that infiltrates from rainwater, and 

that landfill moisture content varies considerable by geographic location. (Tolaymat, 

Tr. 276-77). 

2811. Dr. Tolaymat was also aware that certain landfills practice spray application of liquid 

to waste. (Tolaymat, Tr. 277-78). 

2812. In rejecting the Environ BioPVC study (CCX 739), Dr. Tolaymat testified that it was 

more likely that the mass loss resulted from fragmentation of the BioPVC than from 

biodegradation. (Tolaymat, Tr. 282). 

2813. However, Dr. Tolaymat observed no evidence that suggested fragmentation was 

possible or likely, such as agitation of the test vessels. (Tolaymat, Tr. 282). 

2814. Dr. Tolaymat could not explain the type of mechanical processes that he thought were 

responsible for fragmentation of the BioPVC in lieu of biodegradation. (Tolaymat, 

Tr. 283). 

2815. Dr. Tolaymat never determined whether the PVC plastic would be susceptible to 

fragmentation based on the PVC’s molecular structure. (Tolaymat, Tr. 283). 
 PUBLIC DOCUMENT 

227 

2816. He never considered the PVC molecule’s melting point, glass transition temperature, 

crystallinity, or modulus of elasticity. (Tolaymat, Tr. 283). 

2817. He was not aware whether the negative controls displayed similar results. (Tolaymat, 

Tr. 284). 

2818. Dr. Tolaymat was aware that Dr. Barber at Environ also relied on the presence of free 

chloride ions in solution to show that the PVC molecule had broken down. 

(Tolaymat, Tr. 284-85). 

2819. Dr. Tolaymat agreed that the BioPVC molecule would have originally contained 

chloride. (Tolaymat, Tr. 284). 

2820. Dr. Tolaymat was also aware that the negative control did not display a similar 

increase in chloride ions. (Tolaymat, Tr. 285). 

2821. Dr. Tolaymat dismissed the significance of the chloride ions. (Tolaymat, Tr. 285). 

2822. Dr. Tolaymat suggested that “the free chloride could have come from the ECM 

additive that was used since there was no ECM control by itself.” (Tolaymat, Tr. 

285). 

2823. However, he testified immediately thereafter that the ECM additive “shouldn’t” 

contain polyvinyl chloride. (Tolaymat, Tr. 285). 

2824. In fact, Dr. Tolaymat conceded that “if the ECM additive we are sure does not 

contain chloride, then the chloride obviously would be coming from potentially the 

degradation of the PVC.” (Tolaymat, Tr. 286) (emphasis added). 

2825. Dr. McCarthy, in his report at page 24 n.17, reported that the ECM additive contains 

polyethylene vinyl acetate (EVA), polycaprolactone (PCL), linear low-density 

polyethylene (LLDPE), calcium stearate, and starch, none of which contain chloride 

(CCX 891 at 24 n.17). 

2826. Dr. Tolaymat also concluded that a plateau in the test environment is evidence that 

the test plastic is no longer biodegradable. (Tolaymat, Tr. 287). 

2827. Dr. Tolaymat, without evidentiary support or a basis in fact, testified that exposing a 

partially biodegraded test sample to the atmosphere would render that product 

incapable of further biodegradation testing. (Tolaymat, Tr. 287). 

2828. Dr. Tolaymat conceded, however, that the test plastic is exposed to the atmosphere 

before biodegradation testing. (Tolaymat, Tr. 288). 

2829. He also conceded that if a test sample were returned to a test vessel, the production of 

methane gas would indicate the presence of continued anaerobic biodegradation. 

(Tolaymat, Tr. 289). 
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228 

2830. Dr. Tolaymat’s theory on the “plateau effect” is that once a plateau is observed, the 

ECM additive has been exhausted and there is nothing left to biodegrade. (Tolaymat, 

Tr. 289). 

2831. Without any scientific basis, Dr. Tolaymat rejected the logical idea that a lab could 

retest the partially degraded sample to test whether any portion remains 

biodegradable after the first test. (Tolaymat, Tr. 289). 

2832. Dr. Tolaymat conceded and agreed that, “if the additive is ... exhausted and there’s 

biodegradation, that would be reflective that the test article, the plastic, is degrading.” 

(Tolaymat, Tr. 289). 

2833. Dr. Tolaymat considers cellulose to be a “fully degradable material.” (Tolaymat, Tr. 

290). 

2834. Laboratories use cellulose as a positive control in gas evolution testing precisely 

because the product should be fully biodegradable. (Tolaymat, Tr. 291). 

2835. Dr. Tolaymat conceded that in studies that are in the record, evidence suggests that 

cellulose “plateaued” or stopped degrading well below 90% and in at least one test it 

plateaued under 50%. (Tolaymat, Tr. 292-93). 

2836. Dr. Tolaymat conceded that the material may have stopped biodegrading because “the 

environment that it is in [was] not conducive for complete biodegradation...” 

(Tolaymat, Tr. 292). 

2837. Dr. Tolaymat also rejected many positive ECM D5511 tests because, according to Dr. 

Tolaymat, they did not provide a means to distinguish biodegradation of the plastics 

and the additive. (Tolaymat, Tr. 296). 

2838. He could not explain how plastics are manufactured with the ECM additive. 

(Tolaymat, Tr. 297-98). 

2839. Dr. Tolaymat agreed that other additives, like colorants, which are introduced into the 

plastics in a similar method and at similar percentages as the ECM additive (Sahu, Tr. 

1818-20), appear to be mixed throughout the plastic uniformly. (Tolaymat, Tr. 298-

99). 

2840. Dr. Tolaymat had no reason to think that the ECM additive is not uniformly mixed 

throughout the plastic if manufactured as intended. (Tolaymat, Tr. 299). 

2841. He agreed that the goal of manufacturing the ECM plastic is to achieve a uniform 

distribution throughout the plastic. (Tolaymat, Tr. 299). 

2842. Dr. Tolaymat testified that much of the ECM additive will not, therefore, be 

accessible to the microbes at once. (Tolaymat, Tr. 299). 
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2843. Dr. Tolaymat agreed that the methane sourced from a D5511 test can only be sourced 

from anaerobic biodegradation. (Tolaymat, Tr. 302). 

2844. He testified that the presence of methane in the test environment is an indication that 

there is anaerobic biodegradation. (Tolaymat, Tr. 302). 

2845. The point of a D5511 test, or a “gas evolution” test, is to calculate a percentage of 

biodegradation based on the gas emissions. (Tolaymat, Tr. 303). 

2846. That percentage is calculated by first determining the theoretical yield of gas that 

could possibly be sourced from the test article, assuming complete conversion of 

carbon to gas. (Tolaymat, Tr. 303). 

2847. Dr. Tolaymat agreed that the theoretical yields are appropriate endpoints because 

“there can only be so much carbon in a test sample based on weight.” (Tolaymat, Tr. 

305). 

2848. He also agreed that it would be scientifically appropriate to calculate a maximum 

theoretical yield of gas from the ECM additive alone. (Tolaymat, Tr. 305). 

2849. Dr. Tolaymat did not attempt to calculate a theoretical yield of methane or gas from 

the ECM additive alone. (Tolaymat, Tr. 306). 

2850. Dr. Tolaymat did not consider whether the amount of methane recorded in ECM’s gas 

evolution tests would have been greater than the maximum amount of methane 

theoretically possible from the ECM additive alone. (Tolaymat, Tr. 308-10). 

2851. Dr. Tolaymat testified that a D5511 test of sound methodological quality that 

revealed a percentage of biodegradation in the range of 50%, with just 1% of the 

additive, would be evidence that the plastic was biodegrading and not the additive. 

(Tolaymat, Tr. 314). 

2852. Dr. Tolaymat’s statement that a methodologically sound D5511 test could produce 

evidence that the plastic and not the additive was degrading conflicts with his 

testimony and expert report where he testified that the D5511 test does not allow 

researchers to determine if the plastic degraded above the additive. (Tolaymat, Tr. 

296, 313-14). 

2853. Dr. Tolaymat did not perform any statistical analyses of the test data. (Tolaymat, Tr. 

314-15). 

2854. With respect to NE Labs testing, or any gas evolution testing relevant to the case, Dr. 

Tolaymat did not perform statistical analyses of the data. (Tolaymat, Tr. 316-17). 

2855. Dr. Tolaymat testified that the same raw data available to Dr. Barlaz was also 

available to him. (Tolaymat, Tr. 317). 
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2856. He testified that he was aware of Dr. Barlaz’s statistical calculations, but he did not 

perform the same calculations on his own, or any similar calculations. (Tolaymat, Tr. 

317). 

2857. Dr. Tolaymat was aware of Dr. Barlaz’s statistical calculations based on gas evolution 

data, but Dr. Tolaymat did not review Dr. Barlaz’s statistical calculations. (Tolaymat, 

Tr. 316-17). 

2858. Dr. Tolaymat claimed to have reviewed test data after his deposition, but before the 

hearing, but he testified that he “didn’t do any calculations.” (Tolaymat, Tr. 317). 

2859. Although the raw data was available to him, Dr. Tolaymat did not calculate the ratio 

of methane yield of the substrate to the inoculum yield. (Tolaymat, Tr. 320-21). 

2860. Dr. Tolaymat did not calculate the mean methane in milliliters for the inoculum. 

(Tolaymat, Tr. 320). 

2861. He did not calculate t-statistics for the methane or carbon dioxide readings. 

(Tolaymat, Tr. 321). 

2862. He did not calculate standard deviations. (Tolaymat, Tr. 321). 

2863. He did not calculate ranges. (Tolaymat, Tr. 321). 

2864. He did not calculate the theoretical yield of methane from the ECM additive 

(Tolaymat, Tr. 321-22), yet he testified that the D5511 tests cannot show that the 

biodegradation occurring from the test sample is from the additive. (Tolaymat, Tr. 

207). 

2865. Even when accepting the premise behind Dr. Barlaz’s opinion, and accepting that the 

amount of methane gas stemming from the additive is limited, Dr. Tolaymat still 

insisted that he could not determine whether biodegradation exceeded the maximum 

amount potentially supplied by the ECM additive. (Tolaymat, Tr. 307-10). 

2866. Dr. Tolaymat also rejected aerobic studies of ECM amended plastics solely because 

they were conducted under aerobic conditions. (Tolaymat, Tr. 324). 

2867. Dr. Tolaymat rejected the Ecologicia Applicata aerobic test which revealed 47% 

biodegradation over 180 days, solely because the test did not simulate landfill 

conditions. (Tolaymat, Tr. 324; RX 276). 

2868. Dr. Tolaymat had no basis to conclude that the test reported as RX 276 did not adhere 

to the IS0 14855 standard that was described in the report. (Tolaymat, Tr. 325; RX 

276). 
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2869. He testified that he had no reason to think that the test marked RX 276 was 

methodologically flawed. (Tolaymat, Tr. 326). 

2870. Dr. Tolaymat had no specific belief that the polyamide nylon plastic polymer tested in 

RX 276 was a product that would be aerobically biodegradable but not anaerobically 

biodegradable. (Tolaymat, Tr. 326-27). 

2871. Dr. Tolaymat also rejected all biodegradation studies that did not show “complete” 

biodegradation because, according to Dr. Tolaymat, the only way to prove complete 

biodegradation is to test and actually witness complete biodegradation. (Tolaymat, 

Tr. 329-30). 

2872. Dr. Tolaymat also rejected ASTM D5511 tests because the laboratories measured gas 

weekly. (Tolaymat, Tr. 329). 

2873. He provided no scientific basis to conclude that weekly gas measurements would 

render the data or study conclusions unreliable. (Tolaymat, Tr. 329-31). 

2874. In fact, Dr. Tolaymat himself published two peer reviewed articles wherein he 

employed gas evolution tests and recorded gas readings even less frequent than 

weekly. (Tolaymat, Tr. 330-32). 

2875. Although Dr. Tolaymat testified that he did not “see any scientific issues affecting the 

data from once-per-week gas measurement[s],” he rejected ECM tests that relied on 

weekly measurements. (Tolaymat, Tr. 329-31). 

2876. Dr. Tolaymat did not reject his own study data when he relied on weekly gas 

measurements and, in fact, he relied on that data to support his writings in the peer 

reviewed literature. (Tolaymat, Tr. 332-33). 

2877. The EPA’s Landfill Methane Outreach Program (LMOP) has a mission to reduce 

methane emissions from landfills. (RX 967). 

2878. One of the ways LMPO tries to accomplish its mission is by promoting successful 

recovery of landfill gas emissions. (RX 967). 

2879. In 2013, the EPA had estimated that landfills were supplying already over 102 billion 

cubic feet of usable methane landfill gas per year. (RX 967). 

2880. Dr. Tolaymat conceded that the amount of methane identified by LMOP mostly came 

from those landfills Dr. Tolaymat had described as “dry tomb” landfills. (Tolaymat, 

Tr. 343). 

2881. Dr. Tolaymat also accepted that the EPA LMOP has identified another 600 potential 

landfills for methane gas recovery for beneficial use, most of which would also be 

“dry tomb” landfills as Dr. Tolaymat described them. (Tolaymat, Tr. 343). 
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232 

2882. Dr. Tolaymat conceded that the presence of landfill gas, specifically methane, is an 

indication of biological activity because, in part, “methane can only be sourced in a 

landfill from anaerobic biodegradation.” (Tolaymat, Tr. 340). 

2883. Dr. Tolaymat never discussed his position concerning “dry tomb” landfills with 

colleagues in the EPA’s LMOP. (Tolaymat, Tr. 344). 

2884. Dr. Tolaymat did not share his report with any person in the EPA’s LMOP. 

(Tolaymat, Tr. 344). 

2885. Dr. Tolaymat did not consult with anyone in the EPA’s LMOP when preparing his 

opinion in this case. (Tolaymat, Tr. 344). 

XVIII. AN INCONCLUSIVE TEST IS NOT PROOF OF A NEGATIVE TEST 

2886. Any laboratory test used to measure real-world phenomena is an approximation of the 

real-world situation and, so, scientists must accept that the real world is more 

complex and subject to more factors that cannot be controlled for in the laboratory 

environment. (Sahu, Tr. 1915). 

2887. Dr. Sahu explained that because MSW landfills are so heterogeneous, and that the 

range of conditions are so vast, it would be impossible to “replicate” in one laboratory 

test the conditions present in landfills generally. (Sahu, Tr. 1915-16). 

2888. Gas evolution tests cannot scientifically be rejected simply because they do not 

perfectly replicate all conditions (or even average conditions) found in MSW 

landfills. (Sahu, Tr. 1016-17). 

2889. Many laboratories deviate slightly from the ASTM D5511 protocol. (Sahu, Tr. 1922-

23). Variations of the testing protocol do not render the test data unreliable. (Sahu, 

Tr. 1922-23). 

2890. Dr. Sahu testified that there are concerns with running a closed-system laboratory test 

over longer periods of time. (Sahu, Tr. 1928-29). The test ecosystem must be 

maintained, which is challenging. (Sahu, Tr. 1928-29). 

2891. Unlike in a landfill where biological systems are being replenished and renewed and 

have a greater propensity to thrive, a lab environment can quickly lose activity if the 

biota die. (Sahu, Tr. 1929). 

2892. Biological systems produce waste, and the closed-system laboratory test does not 

permit that waste to be rejected or expelled. (Sahu, Tr. 1930). 

2893. The closed-system laboratory test vessel is also limited in that there may be less 

biological diversity in the test sample than what might exist in the natural 

environment. (Sahu, Tr. 1931). 
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2894. Evidence that a plateau has formed in the laboratory tests can signal that the test 

environment is no longer conductive to biodegradation testing. (Sahu, Tr. 1929). 

That is particularly evident where the plateau forms in the positive control, an article 

known to be biodegradable. (Sahu, Tr. 1929-30). 

2895. Dr. Sahu testified that the presence of a “plateau effect” in the closed-system 

laboratory tests does not mean that biodegradation of the test substrate is no longer 

possible, or that the test substrate is finished biodegrading. (Sahu, Tr. 1931). 

2896. Dr. Sahu explained that there are multiple candidate answers to explain the plateau 

effect, and one of which is that the article has seemingly stopped biodegrading 

because the biological activity in the test vessel has diminished or is no longer 

present. (Sahu, Tr. 1931-32). 

2897. Dr. Sahu reviewed biodegradation tests of ECM plastics that were inconclusive with 

respect to biodegradation. (Sahu, Tr. 1937). 

2898. Dr. Sahu explained that there are many reasons that might point to the cause of an 

inconclusive test. (Sahu, Tr. 1938-39). 

2899. To properly understand an inconclusive test, the scientist must understand, inter alia, 

the biological activity in the test vessels; know whether the additive as in fact 

properly mixed and present in the plastic; know whether the plastic was manufactured 

with the additive properly such that the additive was not rendered ineffective; and 

know whether the presence of other additives or impurities may have hindered 

biodegradation. (Sahu, Tr. 1938-39). 

2900. For instance, Dr. Barber at Environ explained that polystyrene foams did not test well 

in his methodology that is based on weight loss because the foams collect and retain 

too much environmental material. Dolco and EDS produce products that use 

expanded polystyrene. (Barber, Tr. 2148:16-18, 2149:5-11, 2148:6-7). 

2901. Expanded polystyrene has a lot of pore space that can trap dirt and microorganisms, 

and flushing these materials out can be problematic. (Barber, Tr. 2148:16-18, 2149:5-

11). 

2902. The inability to clear out the dirt, bacteria and other materials from these pores can 

result in negative weight loss or weight gain during the exposure period. (Barber, Tr. 

2149:8-12). 

2903. Dispoz-o products are made of both expanded polystyrene and molded polystyrene. 

(Barber, Tr. 2148:8-9). 

2904. FP International produces a product that uses a combination of polyethylene film and 

expanded polystyrene. (Barber, Tr. 2148:10-12). 
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234 

2905. The manufacturing process with the ECM additive is subject to complexities that 

must be controlled for. (Sahu, Tr. 1938-39). 

2906. In the inconclusive studies, the laboratories generally did not follow-up or investigate 

why the study may have been inconclusive. (Sahu, Tr. 1939). 

2907. Even assuming that Complaint Counsel’s priming effect theory is supportable, that 

priming effect would be expected in all ECM studies because the ECM additive itself 

is biodegradable. (Sahu, Tr. 1942). 

2908. If a test shows no biodegradation, or very little biodegradation, then that data is 

inconsistent with Complaint Counsel’s theory on the priming effect. (Sahu, Tr. 1942-

43). That data is also consistent with the implication that manufacturing errors or 

other variables limited the ECM additive’s efficacy or presence in the final product. 

(Sahu, Tr. 1942-43). 

XIX. THIS COURT SANCTIONED COMPLAINT COUNSEL FOR A DISCOVERY 

OBLIGATION

2909. On February 28, 2014, Respondent filed a Motion for Sanctions, asserting that FTC 

Complaint Counsel failed to supplement its document production “in a timely 

manner,” pursuant to FTC Rule 3.31(e)(2). (Order Granting in part and Denying in 

part Resp. Mot. for Sanctions, Dkt. 9358 (March 21, 2014)). 

2910. Complaint Counsel filed an opposition to the Motion on March 10, 2014, and a 

Clarification Regarding Respondent’s Motion for Sanctions on March 13, 2014. 

(Order Granting in part and Denying in part Resp. Mot. for Sanctions, Dkt. 9358 

(March 21, 2014)). 

2911. On March 21, 2014, the Court granted in part Respondent’s Motion for Sanctions, 

because “Complaint Counsel violated its discovery obligation.” (Order Granting in 

part and Denying in part Resp. Mot. for Sanctions, Dkt. 9358 (March 21, 2014)). 

XX. DR. MICHEL, A LAST MINUTE SURPRISE REBUTTAL WITNESS, LACKED 

CREDIBILITY 

2912. On July 9, 2014, Respondent moved to exclude testimony of surprise Complaint 

Counsel Expert witness, Dr. Frederick Michel, to strike his rebuttal report, and for 

sanctions against Complaint Counsel under Rule 3.38(b). (Resp. Mot. for Sanctions 

1-3, (July 9, 2014)).
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235 

2913. Respondent alleged that Complaint Counsel had failed to comply with discovery 

obligations imposed by the rules, and that such conduct was sanctionable under Rule 

3.38(b).

2914. Dr. Michel co-authored a study entitled “Biodegradation of Conventional and BioBased Plastics and Natural Fiber Composites During Composting, Anaerobic 

Digestion and Long-Term Soil Incubation” (“Dr. Michel’s study”). (Michel, Tr. 

2903–04). 

2915. In Dr. Michel’s study, he assessed the anaerobic biodegradability of a wide range of 

commercial available materials used to manufacture plastic products. (Michel, Tr. 

2904). 

2916. One or two of the materials Dr. Michel tested in his study was the ECM additive. 

(Michel, Tr. 2904). 

2917. In order to measure the anaerobic biodegradation of plastics infused with the ECM 

additive, Dr. Michel’s study tested those materials based on a protocol similar to that 

described in ASTM D5511-02. (Michel, Tr. 2904–05). 

2918. At the hearing, Dr. Michel testified that he used the protocol similar to ASTM D5511 

only because that protocol mimicked really anaerobic digestion conditions. (Michel, 

Tr. 2905). 

2919. However, Dr. Michel’s study states that he chose the protocol similar to ASTM 

D5511 because “[t]hese conditions resemble those found in high-solids AD digesters 

and in biologically active landfills.” (Michel, Tr. 2905–06; CCX 880)) (emphasis 

added). 

2920. Dr. Michel further testified at the hearing that he did use the protocol similar to 

ASTM D5511 to test the anaerobic biodegradability of ECM amended plastics at least 

in part because that protocol resembles the environment in a biologically active 

landfill. (Michel, Tr. 2906). 

2921. In testing for anaerobic biodegradation of ECM amended plastics in his peerreviewed study, Dr. Michel used no C-14 radiolabeling testing. (Michel, Tr. 2906; 

CCX 880). 

2922. In fact, Dr. Michel has never tested any polymer using 14C radiolabeling testing. 

(Michel, Tr. 2906). 

2923. In testing for anaerobic biodegradation of ECM amended plastics in his peerreviewed study, Dr. Michel used no in situ testing. (Michel, Tr. 2906–07; CCX 880). 

2924. In testing for anaerobic biodegradation of ECM amended plastics in his peerreviewed study, Dr. Michel used no lysimeter testing. (Michel, Tr. 2906–07; CCX 

880). 
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236 

2925. According to Dr. Michel and Dr. Michel’s study, respirometric testing, like the 

D5511 tests, are generally recognized in the field as competent and reliable evidence 

to show biodegradation. (Michel, Tr. 2907; CCX 880). 

2926. In his study, Dr. Michel defines “biodegradation” as “the mineralization of materials 

as a result of naturally-occurring microorganisms such as bacteria and fungi.” 

(Michel, Tr. 2907–08; CCX 880). 

2927. In the definition of biodegradation that Dr. Michel writes in his study, there is no 

statement of rate of biodegradation or time for biodegradation. (Michel, Tr. 2908; 

CCX 880). 

2928. In fact, Dr. Michel has never defined biodegradation as having to result in a complete 

breakdown of material into elements found in nature within one year after customary 

disposal in any of his peer-reviewed articles. (Michel, Tr. 2908). 

2929. Furthermore, Dr. Michel has never stated in any of his peer reviewed article that 

biodegradation has to occur within any specific time period. (Michel, Tr. 2908). 

2930. However, in his rebuttal report, Dr. Michel conveniently states that: 

Biodegradation in the context of disposable consumer products 

must mean something different. It means that a material will 

biodegrade to natural products over a time frame used for 

municipal waste management via composting, anaerobic digestion 

and/or landfilling. It also implies that materials will biodegrade 

rapidly if they end up in natural environment and will not 

accumulate. 

(Michel, Tr. 2909–10; CCX 895). 

2931. At his deposition, Dr. Michel defined “rapidly,” in the context of the definition of 

biodegradation he stated in his rebuttal report, as: 

[D]uring the process of those waste management technologies, so 

during the composting process, which would be a period of 30 to 

60 days in anaerobic environment, which could include landfills or 

anaerobic digesters, it would be the course of 30 to 60 days. Or in 

a natural environment to the extent of maybe 60 to 90 days that 

material is broken down. 

(Michel, Tr. 2912; RX 970 (Michel, Dep. at 18)). 

2932. So, despite never defining biodegradation to include any rate or time frame in any of 

his peer reviewed articles, Dr. Michel defined biodegradation for purposes of this 

litigation as requiring material to break down within 90 days in any natural 

environment. (Michel, Tr. 2908–12; RX 970 (Michel, Dep. at 18)). 
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237 

2933. According to Dr. Michel, if a plastic product completely breaks down into elements 

found in nature one year after being disposed of in a landfill, that plastic product is 

not biodegradable. (Michel, Tr. 2912–13). 

2934. According to Dr. Michel, if a plastic product completely breaks down into elements 

found in nature 6 months after being disposed of in a landfill, then that plastic product 

is not biodegradable. (Michel, Tr. 2915–16). 

2935. According to Dr. Michel, if a plastic product completely breaks down into elements 

found in nature 3 months after being disposed of in a landfill, then that plastic product 

is not biodegradable. (Michel, Tr. 2916–17). 

2936. However, Dr. Michel is not aware of any plastic product that would always 

biodegrade within 90 in an anaerobic landfill. (Michel, Tr. 2923). 

2937. Dr. Michel is a paid consultant for multiple companies in the composting industry, 

such as DuPont, Indian Summer Composting, AllTreat Organics Composting, 

Amylex, and International Paper, and Myers Company. (Michel, Tr 2919–22). 

2938. Dr. Michel has also consulted for the Federal Trade Commission on two or three 

cases. (Michel, Tr. 2922–23). 

2939. In Dr. Michel’s study, Myers Company prepared the two sample materials 

purportedly containing the ECM additive. (Michel, Tr. 2925; CCX 880). 

2940. Dr. Michel readily admits that he is not an expert on the types of plastic processing 

that Myers used to prepare the samples allegedly blended with the ECM additive. 

(Michel, Tr. 2925). 

2941. Other than simply stating that the samples containing the ECM additive were 

produced by injection molding, Dr. Michel’s article does not indicate the conditions 

for the injection molding. (Michel, Tr. 2926; CCX 880). 

2942. There is nothing in Dr. Michel’s article that identifies anything regarding the 

particular processing conditions that were in the injection molding of the blends 

containing the ECM additive. (Michel, Tr. 2927; CCX 880). 

2943. There is nothing in Dr. Michel’s rebuttal report that discusses anything about the 

particular manufacturing methods and conditions that were used in the injection 

molding of the blends containing the ECM additive. (Michel, Tr. 2927; CCX 895 

(Michel, Rebuttal Rep.)). 

2944. Nothing in Dr. Michel’s study or Dr. Michel rebuttal report provides the molding 

conditions for the negative control employed in Dr. Michel’s study. (Michel, Tr. 

2927–28). 
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238 

2945. Myers Industries first paid Dr. Michel to conduct a study around 2008 or 2009. 

(Michel, Tr. 2928). 

2946. Myers Industries has paid around 40 or 50 thousand dollars for the work done by Dr. 

Michel. (Michel, Tr. 2929). 

2947. Myers’ financial support of 40 or 50 thousand dollars to Dr. Michel and his employer 

culminated in Dr. Michel’s article. (Michel, Tr. 2929). 

2948. Dr. Michel is aware, and has been aware since he first started doing work for Myers, 

that Myers sells pots made out of natural fibers, which means that Myers markets 

those pots as compostable or biodegradable without incorporating the ECM additive. 

(Michel, Tr. 2931–32). 

2949. Myers Industries provided Dr. Michel and his co-author Eddie Gomez with the 

products that were purportedly infused with the ECM additive that were the subject of 

Dr. Michel’s article. (Michel, Tr. 2932–33). 

2950. Dr. Michel does not have any certificate of ingredients regarding the samples 

provided to him by Myers Industries which purportedly contain the ECM additive. 

(Michel, Tr. 2933). 

2951. Dr. Michel never contacted ECM directly to ensure that Myers Industries properly 

manufactured the plastics purportedly containing the ECM additive. (Michel, Tr. 

2935). 

2952. Dr. Michel did no testing to ensure that the plastics Myers Industries told him 

contained the ECM additive actually contained the ECM additive. (Michel, Tr. 

2935–36). 

2953. Dr. Michel did no testing to ensure that the plastics Myers Industries told him 

contained the ECM additive was manufactured in strict accordance with the 

instructions for doing so given by ECM. (Michel, Tr. 2936). 

2954. Dr. Michel did no testing to determine whether the ECM additive had been scorched 

by Myers during the manufacturing process of the plastic products purportedly 

amended with the ECM additive. (Michel, Tr. 2936). 

2955. Dr. Michel did no testing of the test environment in his study to ensure that the 

inoculum contained microbes know to biodegrade plastics. (Michel, Tr. 2936). 

2956. Dr. Michel performed no tests on the samples purporting to contain the ECM additive 

to determine whether any ingredient in the plastic had an adverse effect on microbial 

life forms in the environment. (Michel, Tr. 2938). 

2957. Dr. Michel is not aware of whether or not Compost Science & Utilization Journal, 

which he edits, has a conflict of interest policy. (Michel, Tr. 2937). 
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2958. Dr. Michel is aware of the ethical standards that apply to peer-reviewed journal 

publications in his field. (Michel, Tr. 2939). 

2959. Dr. Michel submitted his article to Elsevier for peer review publication. (Michel, Tr. 

2940). 

2960. When Dr. Michel submitted his study for publication, he submitted only the article 

itself and no other documentation such as the underlying data that the study was 

based on. (Michel, Tr. 2940). 

2961. Elsevier based their decision to publish Dr. Michel’s article solely on the text of the 

article and no underlying data. (Michel, Tr. 2940). 

2962. The data underlying Dr. Michel’s study was not the subject of peer review. (Michel, 

Tr. 2940). 

2963. Myers Industries funded Dr. Michel’s article. (Michel, Tr. 2941). 

2964. Dr. Michel did not disclose to Elsevier that Myers funded his article. (Michel, Tr. 

2942). 

2965. Dr. Michel’s article does not disclose the fact that Myers Industries funded the article. 

(Michel, Tr. 2942; CCX 880). 

2966. Dr. Michel did not disclose the fact that Eddie Gomez, a co-author of Dr. Michel’s 

article, was financially supported mostly by Myers’ contributions to Ohio State 

University. (Michel, Tr. 2942). 

2967. Dr. Michel’s article does not disclose the fact that Myers’ Industries supported Eddie 

Gomez, one of the co-authors of that article. (Michel, Tr. 2942; CCX 880). 

2968. Under an agreement between Dr. Michel, Eddie Gomez, and Myers Industries, Dr. 

Michel could disseminate data obtained and used in the article only after revision by 

Myers Industries. (Michel, Tr. 2943–44; RX 223, at 15). 

2969. Dr. Michel did not disclose to Elsevier the fact that dissemination of the data, which 

was funded by Myers Industries, could only occur after revision by Myers Industries. 

(Michel, Tr. 2944). 

2970. At the hearing, Dr. Michel testified that Myers Industries did not approve his article 

before he sent it to Elsevier. (Michel, Tr. 2945–46). 

2971. However, Eddie Gomez sent Dr. Michel’s article directly to Myers Industries for 

approval before sending the article to Elsevier. (Michel, Tr. 2946–47; RX 244). 

2972. Dr. Michel did not send his article to Elsevier until after Myers Industries approved 

the article. (Michel, Tr. 2947). 
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240 

2973. Dr. Michel did not disclose the fact that Myers Industries approved the article before 

submitting it for peer review to either Elsevier or in the article itself. (Michel, Tr. 

2947). 

2974. Mr. Tarang Shah was an employee for Myers Industries at the time Dr. Michel 

conducted his studies for his article. (Michel, Tr. 2946–48). 

2975. Eddie Gomez asked Tarang Shah whether he had any suggestions for conducting the 

research for Dr. Michel’s article. (Michel, Tr. 2948). 

2976. Dr. Michel failed to disclose the fact that Eddie Gomez asked a Myers Industries 

employee for suggestions regarding the article either to Elsevier or in the article itself. 

(Michel, Tr. 2948). 

2977. Dr. Michel failed to disclose the fact that a Myers Industries employee worked with 

Mr. Gomez and Dr. Michel on the article to either Elsevier or in the article itself. 

(Michel, Tr. 2948). 

2978. Elsevier probably directed Dr. Michel to review the terms and conditions for 

authoring articles in its publications. (Michel, Tr. 2949). 

2979. Dr. Michel would expect that Elsevier, like most, if not all, reputable peer review 

publishers to have a conflict of interest policy. (Michel, Tr. 2949). 

2980. According to Dr. Michel, if Elsevier did not have a conflicts of interest policy, that 

fact would call into question Elsevier’s status as a reputable academic journal. 

(Michel, Tr. 2950). 

2981. Dr. Michel is aware that reputable peer review publishers, like Elsevier, require 

disclosures of conflicts of interest. (Michel, Tr. 2950). 

2982. Elsevier’s conflicts of interest policy requires that all funding sources be declared. 

(Michel, Tr. 2951–52). 

2983. Dr. Michel violated Elsevier’s conflict of interest policy by failing to disclose the fact 

that Myers Industries provided funding for Dr. Michel’s article. (Michel, Tr. 2941, 

2951–52). 

2984. It was so important to Dr. Michel that he and Eddie Gomez finish the report for 

Myers Industries on time that Dr. Michel actually told Eddie Gomez that he should 

drop a course he was taking so that he could complete the report in a timely manner. 

(Michel, Tr. 2953). 

2985. Dr. Michel considers cellulose to be fully biodegradable. (Michel, Tr. 2954). 

2986. In his article, Dr. Michel did not stop his biodegradation test at 365 days. (Michel, 

Tr. 2954–55). 
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241 

2987. In his article, cellulose degraded roughly 74% in approximately 400 days. (Michel, 

Tr. 2955). 

2988. According to Dr. Michel, if a positive control in a biodegradation test does not 

biodegrade, it indicates that the test environment failed. (Michel, Tr. 2959). 

2989. According to Dr. Michel, a material that biodegrades only 44 percent to elements 

found in nature is biodegradable: 

Q. So then a material that only biodegrades 44 percent to elements found in nature 

is biodegradable; right? 

Dr. Michel: Yes. 

 (Michel, Tr. 2961). 

2990. According to Dr. Michel, the fact that cellulose plateaued at 44 percent 

biodegradation in a test does not mean that the cellulose itself is not biodegrade. 

(Michel, Tr. 2961). 

2991. Dr. Michel conducted no investigation of the inoculum used in his article to 

determine if the inoculum remained viable halfway through the test. (Michel, Tr. 

2961–62). 

2992. Dr. Michel conducted no investigation to determine why the cellulose in his test 

stopped degrading at roughly 74 percent. (Michel, Tr. 2962). 

2993. Neither Dr. Michel’s article nor rebuttal report informs the reader as to the molecular 

weight of the polypropylene employed in the article. (Michel, Tr. 2962; CCX 880; 

CCX 895 (Michel, Rebuttal Rep.)). 

2994. Neither Dr. Michel’s article nor rebuttal report informs the reader as to the molecular 

weight of the polystyrene employed in the article. (Michel, Tr. 2962; CCX 880; CCX 

895 (Michel, Rebuttal Rep.)). 

2995. Neither Dr. Michel’s article nor rebuttal report informs the reader as to the level of 

crystallinity of the polypropylene or polystyrene that Dr. Michel employed in his 

article. (Michel, Tr. 2963; CCX 880; CCX 895 (Michel, Rebuttal Rep.)). 

2996. Dr. Michel’s article reveals no investigation to determine which kinds of bacteria 

were alive within the test environment at the conclusion of the test. (Michel, Tr. 

2963). 

2997. The only test of ECM amended plastic that Dr. Michel mentioned in his rebuttal 

report, besides the test he himself conducted, was an Environ BioPVC report. 

(Michel, Tr. 2965–66; CCX 895 (Michel, Rebuttal Rep.)). 

2998. The Environ BioPVC report is not a gas evolution test. (Michel, Tr. 2965). 
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2999. Dr. Michel’s rebuttal report does not contain any statistical analysis of any tests at 

issue in this case. (Michel, Tr. 2966; CCX 895 (Michel, Rebuttal Rep.). 

3000. During his direct examination, Dr. Michel discussed polyethylene succinate. (Michel, 

Tr. 2968). 

3001. In his rebuttal report, Dr. Michel does not mention polyethylene succinate. (Michel, 

Tr. 2968; CCX 895 (Michel, Rebuttal Rep.)). 

3002. Dr. Michel provided no documentation other than a one page estimate that he himself 

drafted regarding the possibility of, and costs associated, with conducting C-14 

radiolabeling testing on plastic polymers. (Michel, Tr. 2968–69; CCX 895 (Michel, 

Rebuttal Rep. at Appx. 2). 

3003. While Dr. Michel testified that its possible to conduct radiolabeled testing on 

polymers, Dr. Michel never testified that the scientific community requires 

radiolabeled testing to conclude that polymers are biodegradable. (Michel, Tr. 2829–

2998). 

3004. The Court accepted ECM’s offer of proof of Dr. Steven Grossman’s testimony as RX 

970, however RX 970 is a different exhibit; Dr. Grossman’s proffer should be 

marked as RX 971. (Tr. 2821; JX-1-A). 
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RESPONDENT’S ECM BIOFILMS’ PROPOSED CONCLUSIONS OF LAW 

OVERVIEW OF APPLICABLE LAW 

1. The FTC’s authority to regulate false or misleading claims derives from the Federal 

Trade Commission Act (“FTC Act”). Section 5 of the FTC Act prohibits “unfair or 

deceptive acts or practices in or affecting commerce.” 15 U.S.C. § 45. 

2. Complaint Counsel bears the burden of proving jurisdiction and liability by a 

preponderance of evidence. In the Matter of POM Wonderful LLC, 2012 WL 2340406, 

at *257 (F.T.C. May 17, 2012). 

COMPLAINT COUNSEL HAVE FAILED TO SATISFY THEIR BURDEN OF 

PROVING THAT ECM VIOLATED THE FTC ACT 

3. The parties’ burdens in this proceeding are governed by Federal Trade Commission Rule 

3.43(a), Section 556(d) of the APA, and case law. 

Complaint Counsel Have Failed To Satisfy Their Burden Of Production

4. “The general provision regarding the burden of proof in administrative hearings is found 

in the Administrative Procedure Act (APA), 5 U.S.C. § 556(d): ‘Except as otherwise 

provided by statute, the proponent of a rule or order has the burden of proof.’” State of 

Me. V. U.S. Dep’t of Labor, 669 F.2d 827, 829 (1st Cir. 1982) (quoting 5 U.S.C. § 

556(d)). 

5. The Court has clarified that the burden of proof in the APA context refers to both the 

burden of persuasion and burden of production. San Miguel Hosp. v. N.L.R.B., 697 F.3d 

1181, 1186 (D.C. Cir. 2012) (citing Dir., Office of Workers’ Compensation Programs, 

Dep’t of Labor v. Greenwich Collieries, 512 U.S. 267, 276 (1994)). “The burden of 

production is the obligation to come forward with evidence of a litigant’s necessary 
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propositions of fact.” Chicago Bridge & Iron Co. N.V. v. F.T.C., 534 F.3d 410, 425 

(D.C. Cir. 2008) (quotation omitted). 

6. At a minimum, that burden requires the calling of fact witnesses sufficient to state a 

prima facie case of deceptive advertising under Section 5 of the FTC Act. See, e.g., 

Cooper v. Salazar, 196 F.3d 809, 815 (7th Cir. 1999) (holding that an effective 

opportunity for cross-examination is required by the Due Process Clause where the 

ultimate decision necessarily requires important credibility determinations). 

7. In FTC administrative proceedings wherein Complaint Counsel is the proponent of a 

proposed order, such as here, Complaint Counsel must first present sufficient evidence to 

support a finding in favor of Complaint Counsel. See Creswell Trading Co. Inc. v. U.S., 

15 F.3d 1054, 1060 (Fed. Cir. 1994) (noting that the “burden of production is initially 

upon the party who bears the ultimate burden of proof and generally requires that a party 

produce sufficient evidence to support a finding in favor of that party”). 

8. In this case, Complaint Counsel failed to satisfy its burden of production because, among 

other reasons, Complaint Counsel failed to present any evidence whatsoever that any 

consumer relied on any claim made by ECM when making a purchasing decision. In 

fact, Complaint Counsel has not provided any evidence that any consumer actually 

purchased any plastic containing the ECM additive. Complaint Counsel has further 

failed to provide any evidence showing that any consumer or entity was harmed as a 

result of any claim made by ECM. 
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ECM has Conducted no Advertising Material to a Purchase; Therefore, ECM has Made no 

Claims that are Actionable 

9. The FTC defines advertisement “to mean a notice or announcement that is publicly 

published and is paid-for.” In the Matter of R.J. Reynolds Co., Inc., FTC Dkt. No. 9206, 

1988 WL 490114, at *2 (Mar. 4 1988). 

10. “Advertising is a form of promotion to anonymous recipients, as distinguished from faceto-face communication. In normal usage, an advertisement read by millions (or even 

thousands in a trade magazine) is advertising, while a person-to-person pitch by an 

account executive is not.” First Health Grp. Corp. v. BCE Emergis Corp., 269 F.3d 800, 

803–04 (7th Cir. 2001).1 Therefore, an in person statement by a company’s sales team is 

not “advertising.” Zurich Ins. Co. v. Amcor Sunclipse N. Am., 241 F.3d 605, 607 (7th 

Cir. 2001). Likewise, statements by a company’s executive made in person to other 

executives cannot be called “commercial advertising or promotion.” First Health, 269 

F.3d at 804. Similarly, in order to constitute “promotion,” materials must be 

“disseminated sufficiently.” Coastal Abstract Serv., Inc. v. First Am. Title Ins. Co., 173 

F.3d 725, 735 (9th Cir. 1999); Seven-Up Co. v. Coca-Cola Co., 86 F.3d 1379, 1384 (5th 

Cir. 1996) (same). 

11. Under the legal definition of advertising, the material basis for sale of the ECM additive 

does not depend on advertising. 

Complaint Counsel Have Failed To Satisfy Their Burden Of Proof 

12. Pursuant to Commission Rule 3.43(a), “Counsel representing the Commission . . . shall 

have the burden of proof, but the proponent of any factual proposition shall be required to 

                                                             1

 Black’s law definition defines an “advertisement” as “notice given in a manner 

designed to attract public attention.” 
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sustain the burden of proof with respect thereto.” 16 C.F.R. § 3.43(a); see also 5 U.S.C. 

§ 556(d) (explaining that “the proponent of a rule or order has the burden of proof”). 

13. Regardless of the level of substantiation required, the FTC will bear the burden of 

proving advertising claims are false or misleading. See Sterling Drug, Inc. v. F.T.C., 741 

F.2d 1146, 1150 (9th Cir. 1984); Porter & Dietsch, Inc. v. F.T.C., 605 F.2d 294, 305 (7th 

Cir. 1979); F.T.C. v. Garvey, 383 F.3d 891, 900 (9th Cir. 2004) (“we put the burden of 

proving falsity or deception on the FTC”). 

14. To prove that an advertisement is false or misleading, the FTC must show (1) the 

existence of a “representation, omission, or practice,” that is (2) “likely to mislead 

consumers acting reasonably under the circumstances,” and that 3) “the representation, 

omission, or practice is material.” F.T.C. v. Bronson Partners, LLC, 564 F. Supp. 2d 

119, 124 (D. Conn. 2008) (citation omitted). 

15. The determination of whether challenged claims are false or misleading, begins with 

ascertainment of the level of substantiation Respondents are required to have for their 

advertising claims. Respondents have the burden of establishing what substantiation they 

relied on for their product claims. Complaint Counsel has the burden of proving that 

Respondents' purported substantiation is inadequate. In the Matter of POM Wonderful 

LLC, 2012 WL 2340406, at *259 (F.T.C. May 17, 2012). 

16. An advertisement is deceptive under the FTC Act only if it is likely to mislead 

consumers, acting reasonably under the circumstances, in a material respect. In the 

Matter of POM Wonderful LLC, 2012 WL 2340406, at *258 (F.T.C. May 17, 2012). 

17. “The Commission shall have no authority under this section or section 57a of this title to 

declare unlawful an act or practice on the grounds that such act or practice is unfair 
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unless the act or practice causes or is likely to cause substantial injury to consumers

which is not reasonably avoidable by consumers themselves and not outweighed by 

countervailing benefits to consumers or to competition. In determining whether an act 

or practice is unfair, the Commission may consider established public policies as 

evidence to be considered with all other evidence. Such public policy considerations may 

not serve as a primary basis for such determination.” 15 U.S.C. § 45 (emphasis added). 

18. A consumer is defined as “an individual” or a “natural person.” 15 U.S.C. §§ 1681a, 

1693a, 6603, 1679a. In order to be considered a “consumer,” the individual or natural 

person must “obtain, through a transaction, products or services which are used primarily 

for personal, family, or household purposes.” 15 U.S.C. § 7006; 52 U.S.C. § 3501. In 

other words, “consumer” means “a buyer (other than for purposes of resale) of any 

consumer product, any person to whom such product is transferred during the duration of 

an implied or written warranty (or service contract) applicable to the product, and any 

other person who is entitled by the terms of such warranty (or service contract) or under 

applicable State law to enforce against the warrantor (or service contractor) the 

obligations of the warranty (or service contract).” 15 U.S.C. § 2301. Similarly, a 

consumer means a natural person who uses products for personal rather than business 

purposes. 40 C.F.R. § 721.8100; 15 C.F.R. § 16.3. A retailer buying consumer products 

for resale from the manufacturer is not within the definition of “consumer.” Black v. Don 

Schmid Motor, Inc., Kan.1983, 657 P.2d 517, 232 (Kan. 1983). Consumer cannot include 

any person “operating as a manufacturer, distributor, wholesaler, or retailer...” 15 U.S.C. 

§ 375. A consumer product 
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19. “Two theories have been used to prove that an advertisement is deceptive or misleading: 

(1) the ‘falsity’ theory or (2) the ‘reasonable basis’ theory.” In the Matter of Pom 

Wonderful LLC, 9344, 2012 WL 2340406 (F.T.C. May 17, 2012) (at 234) (citing Pantron 

I, 33 F.3d at 1096). 

20. Where the “issue of whether Respondents’ claims were deceptive turns on the nature and 

quality of Respondents’ substantiation ... the falsity and reasonable basis theories 

collapse into the same inquiry: did [Respondents] possess adequate substantiation to 

make such a claim?” Id. (quoting FTC v. QT, Inc., 448 F.Supp. 2d 908, 966 (N.D. Ill. 

2006)). 

21. Proof of deception requires an analysis of the evidence as follows: 

[T]he Court must first determine what level of substantiation Defendants 

were required to have for their advertising claims, and this determination is 

a question of fact. Then, the Court must determine whether the Defendants 

possessed that level of substantiation ... Defendants have the burden of 

establishing what substantiation they relied on for their product claims. The 

FTC has the burden of proving that the Defendants’ purported substantiation 

is inadequate... 

22. FTC v. QT, Inc., 448 F. Supp. 2d at 959 (citations omitted). For efficacy claims, the 

Commission must determine the level of substantiation by applying the Pfizer factors. In 

re Pfizer, Inc., 81 F.T.C. 23 (July 11, 1972). 

23. Complaint Counsel must prove each element of its case by a preponderance of the 

evidence. See, e.g., In re Adventist Health Sys./West, 117 F.T.C. 224, 297 (Apr. 1, 1994) 

(explaining that “[e]ach element of the case must be established by a preponderance of 

the evidence”); see also In the Matter of POM Wonderful, LLC, 2012 WL 2340406, at 

*171 (F.T.C. May 17, 2012) (noting that “Complaint Counsel has the burden of proving 

each of the foregoing factual issues by a preponderance of credible evidence”). 
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24. “The burden of showing something by a ‘preponderance of the evidence’ ... requires the 

trier of fact to believe that the existence of a fact is more probable than its nonexistence 

before he may find in favor of the party who has the burden to persuade the judge of the 

fact’s existence.” Concrete Pipe & Prods., Inc. v. Construction Laborers Pension Trust, 

508 U.S. 602, 622 (1993) (internal quotations and citations omitted). 

25. Complaint Counsel has the burden of proving by a preponderance of credible evidence 

that ECM made the alleged claims in the challenged advertising and did not have a 

reasonable basis for such claims. In the Matter of Bristol-Myers Co., 102 F.T.C. 21, 1983 

FTC LEXIS 64, at *143 (requiring proof by “preponderance of credible evidence”); FTC 

v. QT, Inc., 448 F. Supp. 2d 908, 959 (N.D. Ill. 2006) (holding that to prevail on a 

reasonable basis theory, the FTC must prove that the advertiser lacked a reasonable basis 

for asserting the challenged claim, that the advertiser has the burden of establishing the 

substantiation it relied on for its claim, and that the FTC has the burden of proving the 

advertiser’s substantiation is inadequate), aff’d 512 F.3d 858 (7th Cir. 2008). 

Complaint Counsel Failed to Satisfy Their Burden that ECM Made an Implied Claim that 

Plastic Containing the ECM Additive Will Decompose Into Elements Found in Nature 

Within One Year of Customary Disposal 

26. An advertisement is deemed to convey a claim if a significant minority of reasonable 

consumers would find the advertisement to contain that message. Whether an 

advertisement conveys a claim is a question of fact. In the Matter of POM Wonderful 

LLC, 2012 WL 2340406, at *257 (F.T.C. May 17, 2012). 

27. To determine whether an advertisement conveys an alleged claim, the first step is to 

examine the advertisement itself (a “facial analysis”). A proper facial analysis requires an 

evaluation of such factors as the entire document, the juxtaposition of various phrases in 
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the document, the nature of the claim, and the nature of the transaction. In the Matter of 

POM Wonderful LLC, 2012 WL 2340406, at *257 (F.T.C. May 17, 2012). 

28. “[I]n determining what claims are conveyed by a challenged advertisement, the 

Commission relies on two sources of information: its own viewing of the ad and 

extrinsic evidence. Its practice is to view the ad first and, if it is unable on its own to 

determine with confidence what claims are conveyed in a challenged ad, to turn to 

extrinsic evidence.” Kraft, Inc. v. F.T.C., 970 F.2d 311, 318 (7th Cir. 1992). 

29. If, after viewing the advertisement as a whole, examining the interaction of all the 

different elements in the advertisement, it can be concluded with confidence that an 

advertisement can reasonably be read to contain a particular claim, a facial analysis is a 

sufficient basis to conclude that the advertisement conveys the claim. However, an 

implied claim must be reasonably clear or conspicuous from the face of the 

advertisement. In the Matter of POM Wonderful LLC, 2012 WL 2340406, at *257 

(F.T.C. May 17, 2012). 

30. If, after a facial analysis, it cannot be concluded with confidence that a particular 

advertisement can reasonably be read to contain a particular implied message, the 

advertisement will not be deemed to have made the alleged claim unless extrinsic 

evidence supports the conclusion that such a reading of the advertisement is reasonable. 

In the Matter of POM Wonderful LLC, 2012 WL 2340406, at *257 (F.T.C. May 17, 

2012). 

31. The FTC must use extrinsic evidence to determine what the claim implies when the claim 

is not “reasonably clear from the face of the advertisement.” F.T.C. v. Bronson Partners, 

LLC, 564 F. Supp. 2d 119, 126 (D. Conn. 2008). And as another case clarified, “if the 
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language or graphic is susceptible to more than one reasonable interpretation . . . the 

district court must look to consumer data to determine what the person to whom the 

advertisement is addressed finds to be the message.” Time Warner Cable, Inc. v. 

DIRECTV, Inc., 497 F.3d 144, 158 (2d Cir. 2007). 

32. A facial analysis of the claim “biodegradable” does not reasonably lead to the conclusion 

that the term “biodegradable” implies decomposition into elements found in nature within 

one year after customary disposal. 

33. Complaint Counsel does not contend that ECM made any express claim that plastic 

containing the ECM additive will decompose into elements found in nature within one 

year after customary disposal. Furthermore, it is not “conspicuous and ‘reasonably clear 

from the face of the advertisements2

’” that the naked claim of “biodegradable” on a 

product implies that the product will decompose into elements found in nature within one 

year of customary disposal. See F.T.C. v. QT, Inc., 448 F. Supp. 2d 908, 958 (N.D. Ill. 

2006) (quoting Kraft, Inc. v. F.T.C., 970 F.2d 311, 320 (7th Cir. 1992)). Therefore, 

Complaint Counsel must present extrinsic evidence that provides proof by a 

preponderance of the evidence that a significant minority of consumers, Kraft, 114 F.T.C. 

at 60, understand the term “biodegradable” on a plastic product to mean that the product 

will decompose into elements found in nature within one year after customary disposal. 

F.T.C. v. Bronson Partners, LLC, 564 F, Supp. 2d 119, 127 (D. Conn. 2008) (citing In 

the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648 (1984) (explaining that, under 

Kraft and its progeny, the FTC requires extrinsic evidence “if its initial review of 

evidence from the advertisement itself does not allow the FTC to conclude with 

                                                             2

 Assuming arguendo that ECM has made any “advertisement.” 
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confidence that it is reasonable to read an advertisement as containing a particular 

implied message”). 

The Extrinsic Evidence Disproves the Notion that Consumers Interpret the Word 

“Biodegradable” to Mean Decompose into Elements Found in Nature Within One Year of 

Customary Disposal 

34. Express claims unequivocally state the representation at issue. No further proof about the 

meaning of an express claim is necessary because the express claim itself is explicitly 

stated. See FTC Deception Policy Statement, appended to Cliffdale Assocs., Inc., 103 

F.T.C. at 176; Thompson Medical Co., 104 F.T.C. at 788. 

35. Implied claims are any claims that are not express. See In the Matter of Kraft, Inc., 114 

F.T.C. 40, 120 (1991). Because implied claims are not stated explicitly, Complaint 

Counsel must prove that they are conveyed to a significant minority of reasonable 

consumers. Id. 

36. When an implied claim is at issue, “[t]he Commission will carefully consider any 

extrinsic evidence that is introduced, taking into account the quality and reliability of the 

evidence.” In re Stouffer Foods Corp., 118 F.T.C. 746, 799 (Sept. 26, 1994). Such 

extrinsic evidence includes “reliable results from methodologically sound consumer 

surveys.” Id. (emphasis added). In weighing survey evidence, the Commission “looks 

to whether such evidence is reasonably reliable and probative. Flaws in the methodology 

may affect the weight that is given to the results of the copy test or other consumer 

survey.” Id. (citation omitted). 

37. Extrinsic evidence includes survey results and other evidence governing how consumers 

may have perceived certain claims. Kraft, 114 F.T.C. at 121. The Commission can look 

at: 
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evidence not specifically showing how consumers understood 

the advertisements at issue before us, but showing 

how consumers might ordinarily be expected to perceive or 

understand representations like those contained in the ads we are 

reviewing. For example, we might look at the dictionary 

definition of a word to identify the word's common usages. Or 

we might look at principles derived from market research, as 

expressed by marketing experts, which show that 

consumers generally respond in a certain manner to ads that are 

presented in a particular way, and presume 

that consumer reactions to a particular ad before us would be 

consistent with the general response pattern. Where we apply 

such marketing principles, we will derive them from research 

presented in references generally accepted as reliable in the field 

of marketing. Such references may be cited by marketing experts 

called to testify in the proceeding. 

In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648 (1984). 

38. Implied claims may only be found where it is determined with confidence, after 

examining all of the constituent elements of the advertising, that the challenged claims 

are conspicuous, self-evident, or reasonably clear on the face of the ad. Stouffer, 118 

F.T.C. at 777 (citing Kraft, 970 F.2d at 318); Thompson Medical, 104 F.T.C. at 320. 

This Court Must Interpret ECM’s Claims, Both Implied and Express, through the 

Perspective of the Target Audience for Those Claims—Sophisticated Plastic 

Manufacturers 

39. “Target audiences,” for purposes of interpreting advertising, refer to special audiences 

who as a group have a greater or lesser capability to recognize deceptive advertising than 

ordinary members of the adult population or have a distinctive reaction to particular 

advertising claims. In the Matter of POM Wonderful LLC, 2012 WL 2340406, at *259 

(F.T.C. May 17, 2012). 

40. “In reviewing allegedly false and misleading statements, courts are to read the statements 

in their entirety and in context to determine whether they are actionable.” Schering-
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Plough Healthcare Prods., Inc. v. Schwartz Pharma, Inc., 547 F. Supp. 2d 939, 943 (E.D. 

Wisc. 2008) (citing Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134, 1139 (9th 

Cir 1997) (“[w]hen evaluating whether an advertising claim is literally false, the claim 

must always be analyzed in its full context”)); Castrol, Inc. v. Pennzoil Co., 987 F.2d 

939, 946 (3d Cir. 1993) (“in assessing whether an advertisement is literally false, a court 

must analyze the message conveyed in full context”); Schwarz Pharma, Inc. v. 

Breckenridge Pharm., Inc., 388 F.Supp.2d 967, 976 (E.D. Wis. 2005) (“To determine 

whether a particular representation is literally false, it must be analyzed with its full 

context”)). “In addition, the specific audience is part of the context that must be 

considered in deciding whether a statement is literally false.” Id. 

41. “Context can often be important in discerning the message conveyed and this is 

particularly true where, as here, the target of the advertising is not the consuming 

public but a more well informed and sophisticated audience.” Sandoz Pharms. Corp. 

v. Richardson-Vicks, Inc., 902 F.2d 222, 229 (3d Cir. 1990) (emphasis added) (citation 

and internal quotation marks omitted); see also DeSena v. Beekley Corp., 729 F. Supp. 2d 

375, 393 (D. Me. 2010) (“A target audience’s special knowledge of a class of products is 

highly relevant to any claim that it was misled by an advertisement for such a product”). 

42. Similarly, “[w]hen the practice [at issue] is targeted to a sophisticated purchaser, the 

question of whether it is misleading to the public will be viewed from the vantage point 

of members of the targeted group, not others to whom it is not primarily directed.” Ariz. 

Cartridge Remanufacturers Assoc., Inc. v. Lexmark Int’l, Inc., 290 F. Supp. 2d 1034, 

1041 (N.D. Cal. 2003). 
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ECM’s Claims Could Not Have Misled Because ECM’s Customers Are Sophisticated 

Plastic Manufacturers Who Evaluated the ECM Product Before Purchase 

43. In business transactions, when the selling company provides the purchasing company 

with specifications or data, such transactions are “classified as sophisticated.” John 

Crane Prod. Solutions, Inc. v. R2R and D, LLC, 861 F. Supp. 2d 792, 799 (N.D. Tex. 

2012). 

44. Even if “a company’s engineers may be distinct from the employees who purchased the 

[product] . . . [s]uch business transactions are at least as complex as transactions that 

other courts have classified as sophisticated.” John Crane Prod. Solutions, Inc. v. R2R 

and D, LLC, 861 F. Supp. 2d 792, 799 (N.D. Tex. 2012). 

45. There is less likelihood of confusion when the parties to a business transaction “have a 

close working relationship.” Id. at 801. In fact, “[c]ourts have found that the 

sophistication of the potential purchasers alone is enough to find that there is no 

likelihood of confusion even when all of the other digits [in the trademark context] weigh 

in favor of such a finding. See, e.g., Perini Corp. v. Perini Constr., 915 F.2d 121, 128 

(4th Cir.1990) (reversing summary judgment because district court did not consider how 

sophistication of purchasers of construction services affected analysis, even though all 

other digits weighed in favor of finding likelihood of confusion).” Id. at n. 16. 

46. Courts have classified transactions and purchasers as sophisticated in a number of 

contexts. See, e.g., Checkpoint Sys., Inc. v. Check Point Software Tech., 269 F.3d 270, 

285 (3d Cir.2001) (holding that purchasers of retail store security equipment and 

computer security software were sophisticated); Rust Env't & Infrastructure, Inc. v. 

Teunissen, 131 F.3d 1210, 1217 (7th Cir. 1997) (holding that purchasers of services from 

engineering consulting firms were sophisticated); Oreck v. U.S. Floor Sys., Inc., 803 F.2d 
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166, 173 (5th Cir. 1986) (“because these persons are buying [vacuums and extraction 

machines] for professional and institutional purposes at a cost in the thousands of dollars, 

they are virtually certain to be informed, deliberative buyers”); Armstrong Cork Co. v. 

World Carpets, Inc., 597 F.2d 496, 504 n. 10 (5th Cir. 1979) (“a person buying a ‘big 

ticket’ item such as carpeting would ordinarily be expected to be a more careful buyer 

than the impulse purchaser or the purchaser of a relatively inexpensive item”). 

47. In order to succeed in a fraud action, a challenger must establish that he or she reasonably 

relied on the alleged material representation. Terra Sec. Asa Konkursbo v. Citigroup, 

Inc., 740 F. Supp. 441, 448 (S.D.N.Y. 2010). “In assessing the reasonableness of a 

plaintiff’s alleged reliance, [courts] consider the entire context of the transaction, 

including factors such as its complexity and magnitude, the sophistication of the parties, 

and the content of any agreements between them.” Emergent Capital Inv. Mgmt., LLC v. 

Stonepath Grp., Inc., 343 F.3d 189, 195 (2d Cir. 2003). For example, [s]ophisticated 

investors must investigate the information available to them with the care and prudence 

expected from people with full access to information.” Terra, 740 F. Supp. 2d at 448 

(citing Hirsch v. du Pont, 553 F.2d 750, 763 (2d Cir. 1977)); see also Banque Franco–

Hellenique de Commerce Int’l., et Maritime, S.A. v. Christophides, 106 F.3d 22, 27 (2d 

Cir. 1997) (finding that analysis of reasonable reliance in fraud cases “has taken account 

of the degree to which the truth was accessible to the defrauded person”). The rationale 

being that the informed or sophisticated entity has the wherewithal to determine whether 

claims are supported and, so, the need to protect those sophisticated “consumers” is 

lessened. 
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48. Other courts outside of the Second Circuit have similar requirements to determine 

whether sophisticated purchasers reasonably relied on misrepresentations. See, e.g., 

Metavante Corp. v. Emigrant Sav. Bank, 619 F.3d 748, 767–68 (7th Cir. 2010) (finding 

that the plaintiff’s alleged reliance was unreasonable where “two sophisticated businesses 

negotiated an arms-length transaction of a period of several months”); Tom Hughes 

Marine, Inc. v. Am. Honda Motor Co., Inc., 219 F.3d 321, 324 (4th Cir. 2000) (affirming 

decision that reasoned that the plaintiff was “a sophisticated businessman ... and he [was] 

unable to establish that he had a right to rely on [the defendant’s] representation or that 

he justifiably relied upon it”); Gilchrist Timber Co. v. ITT Rayonier, Inc., 95 F.3d 1033, 

1035 (11th Cir. 1996) (collecting cases supporting the proposition that a fraud claim is 

not actionable where “the parties are equally sophisticated, and have an equal opportunity 

to discover a defect”); Cheney Bros., Inc. v Batesville Casket Co., Inc., 47 F.3d 111, 114 

(4th Cir. 1995) (citation omitted) (holding that “there is no right to rely, as required to 

establish fraud, where there is no confidential or fiduciary relationship, and there is an 

arm's length transaction between mature, educated people”); Kline v. First Western Gov’t 

Sec., Inc., 24 F.3d 480, 497–98 (3d Cir. 1994) (holding that the “investor could not 

justifiably rely on representations” where the transaction “was on the cutting edge of 

strategic planning”); Roberts v. United N. Mex. bank at Roswell, 14 F.3d 1076, 1080 at n. 

4 (5th Cir. 1994) (internal quotations and citations omitted) (“If an investor is 

sufficiently sophisticated and experienced, that may be evidence that he did not rely on 

the seller's representations but on his own expertise.”); Davidson v. Wilson, 973 F.2d 

1391, 1399 (8th Cir. 1992) (noting that the “sophisticated investors should have been on 

notice not to rely upon those representations”); Skeen v. C.I.R., 864 F.2d 93, 95 (9th Cir. 
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1989) (explaining that where the plaintiffs “are all sophisticated businessmen,” the court 

“simply do[es] not believe that they would enter into profit-motivated transactions with 

an unknown party and rely solely on the representations of such part with respect to the 

most crucial aspect affecting the viability of the proposed venture”). 

49. In the trademark context, courts find that there is a reduced likelihood that a sophisticated 

party, as opposed to an unsophisticated party, will be influenced by a similar mark in an 

advertisement. See, e.g., Mead Data Dent., Inc. v. Toyota Motor Sales, U.S.A., Inc., 875 

F.2d 1026, 1031–32 (2d Cir. 1989). “The degree of consumer care and sophistication can 

be proven by survey evidence, expert testimony, or inference.” Marketquest Grp., Inc. v. 

BIC Corp., 2011 WL 5360899, at *12 (S.D. Cal. Nov. 7, 2011) (citation omitted) (finding 

that the buyers were likely to be sophisticated because they were institutional buyers 

placing bulk orders and because the marketing materials “appear to be aimed at 

institutional purchasers”). 

50. The issue in Mead was whether the use of the term “Lexus” used by Toyota Motors 

would dilute the profitability of the term “Lexis” as used by Mead. Mead, 875 F.2d at 

1027. The Second Circuit explicitly made clear that “the recognized sophistication of 

attorneys, the principal users of [Lexis], has substantial relevance.” Id. at 1031 

(emphasis added). Given the fact that Lexis’ users were principally sophisticated 

attorneys, the court concluded that there would not “be any significant amount of blurring 

between the LEXIS and LEXUS marks.” Id. at 1032. 

51. In Mead, the court did not evaluate each individual attorney’s level of sophistication to 

ensure that each attorney was capable him or herself of differentiating between Lexus and 

Lexis. Rather, the court found that the mere fact that Mead’s customers were attorneys 
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had substantial relevance. Likewise, need not evaluate each of ECM’s customers to 

determine how sophisticated each is. Rather, the fact that the customers are plastic 

manufacturers has substantial relevance when determining whether any customer can 

possibly be misled when purchasing a product to be used for commercial purposes during 

the plastic manufacturing process. 

52. Numerous additional courts likewise find that purchasers are less likely to be confused 

when they are sophisticated, technical, experienced, retailers, or otherwise involved in the 

industry or have any relevant knowledge. See, e.g., In re Synthroid Mktg. Litig., 264 F.3d 

712, 717 (7th Cir. 2001) (noting that “[u]nlike members of the consumers class, [third 

party payors] are sophisticated purchasers”); Interstellar Starship Servs., Ltd. v. Epix Inc., 

184 F.3d 1107, 1110 (9th Cir. 1999) (citation omitted) (holding that confusion is less 

likely where the “customers are sophisticated industry and university researchers” and 

where the “goods cost in the range of several thousand to tens of thousands of dollars”);

Homeowners Grp., Inc. v. Home Mktg. Specialists, Inc., 931 F.2d 1100, 1111 (6th Cir. 

1991) (“A sophisticated purchaser exercises a high degree of care and is less likely to be 

confused as to a product's origin.”); Pride Family Brands, Inc. v. Carl’s Patio, Inc., 992 

F. Supp. 2d 1214, 1222 (S.D. Fla. 2014) (noting that “[as] industry participants, retailers 

are a sophisticated customer base”); Acxiom Corp. v. Axiom, Inc., 27 F. Supp. 2d 478, 

497 (D. Del. 1998) (citations omitted) (explaining that “courts recognize that generally” 

when a seller “sell[s] relatively expensive products and services to sophisticated and 

knowledgeable purchasers that typically involve relatively long sales cycles . . . these 

factors indicate that great care, effort, and attention go into the purchase decision making 

which lessens likelihood of confusion.”); Giorgio Beverly Hills, Inc. v. Revlon Consumer 
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Prods. Corp., 869 F. Supp. 176, 185 (S.D.N.Y. 1994) (citation omitted) (explaining that 

“[t]he more sophisticated the ordinary purchaser of a product is, the less likely it is that 

the use of similar marks or trade dress will lead to confusion” and holding that “women 

tend to be sophisticated purchasers of perfume”); Marketquest, 2011 WL5360899, at *11 

(noting that “experienced industry distributors or agents [] are likely to be sophisticated 

consumers and investigate any potential confusion”); In re Trans Union Corp. Privacy 

Litig., 2009 WL 4799954, at *11 (N.D. Ill. Dec. 9, 2009) (noting that insurance 

companies are sophisticated purchasers of legal services). 

53. Like in the trademark context, parties are held to different levels of duty of disclosure 

when conducting business with sophisticated purchasers as opposed to the general public. 

For example, a purchaser is under no duty to disclose the financial conditions of its 

business when “the parties are represented by sophisticated businessmen, who are active 

and experienced in the area, and are dealing at arm’s length without any fiduciary or 

confidential relationships or expectations.” Nationwide Book Indus., LLC v. A & S 

Booksellers, Inc., 950 F. Supp. 2d 264, 267 (D. Mass. 2013) (citations and quotations 

omitted). 

54. Similarly, in the securities context, securities issuers must disclose significantly more 

information when making public offering as opposed to selling the securities only to 

sophisticated qualified institutional buyers. Gustafson v. Alloyd Co., 513 U.S. 561, 569 

(1995) (citing 15 U.S.C. §§ 77b(11), 77d, 77e) (“By and large, only public offerings by 

an issuer of a security, or by controlling shareholders of an issuer, require the preparation 

and filing of registration statements.”). This is because the sophisticated purchaser, 

capable of fending for itself and determining the benefits and costs of entering a business 
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transaction, are held liable for their own decisions. See, e.g., Miller v. Berman, 289 F. 

Supp. 2d 1327, 1334 (M.D. Fla. 2003) (“Surely, as a sophisticated boat and sail maker, 

Mr. Miller relied on his own expertise in deciding to enter into a contract for the purchase 

of a highly customized catamaran boat with Cougar Marine”). 

55. ECM representations are targeted to plastic manufacturers. The plastic manufacturers, 

unlike consumers, are sophisticated buyers who technically evaluated samples of the 

ECM additive with the aid of scientists, engineers, lawyers, and marketers before 

purchasing it for infusion into their plastics and spent six months to two years performing 

an assessment. Based on that sophistication, they may be presumed impervious to 

deception related to the characteristics of biodegradability of the ECM plastic. Perini 

Corp., 915 F.2d at 128; Checkpoint Sys., 269 F.3d at 285; Oreck, 803 F.2d at 173; 

Armstrong Cork, 597 F.2d at 504 n. 10; Metavante Corp., 619 F.3d at 767–68; Tom 

Hughes, 219 F.3d at 324; Gilchrist Timber, 95 F.3d at 1035; Cheney Bros., 47 F.3d at 

114; Roberts, 14 F.3d at 1080 n. 4; Davidson, 973 F.2d at 1399; Skeen, 864 F.2d at 95; 

Mead, 875 F.2d at 1031–32; Synthroid Mktg., 264 F.3d at 717; Interstellar Starship, 184 

F.3d at 1110; Homeowners Grp., 931 F.2d at 1111; Pride Family, 992 F. Supp. 2d at 

1222; Acxiom Corp., 27 F. Supp. 2d at 497; Giorgio Beverly Hills, 869 F. Supp. at 185; 

Miller, 289 F. Supp. 2d at 1334; Marketquest, 2011 WL 5360899, at *12; In re Trans 

Union, 2009 WL 4799954, at *11. 

56. A manufacturer’s duty to warn of dangers in the products liability context is “precluded 

in situations where the purchaser has particular knowledge of or experience with the 

inherent dangers in the use of a product or in instances when the purchaser has designed 

and requested a product for a particular application.” Byrd v. Hunt Tool Shipyards, 650 
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F.2d 44, 47 at n. 1 (5th Cir. 1981); see also O’Neal v. Celanese Corp., 10 F.3d 249, 252 

(4th Cir. 1993) (“The [sophisticated purchaser] defense is available not only when the 

supplier actually warned the intermediary, but also when the supplier shows that it was 

reasonable to believe that a warning was unnecessary because the intermediary was 

already well aware of the danger”); Goodbar v. Whitehead Bros., 591 F. Supp. 552, 561 

(W.D. Va. 1984 ) (“Stated another way, when the supplier has reason to believe that the 

purchaser of the product will recognize the dangers associated with the product, no 

warnings are mandated”). This rule of law is known as the “sophisticated purchaser 

defense” which is “based upon the principles set forth in the Restatement (Second) of 

Torts.” Akin v. Ashland Chem. Co., 156 F.3d 1030, 1037 (10th Cir. 1998). “This 

exception absolves suppliers of the duty to warn purchasers who are already aware or 

should be aware of the potential dangers.” Id. (citing O’Neal, 10 F.3d 249, 251–52 (4th 

Cir. 1993); Davis v. Avondale Indus., 975 F.2d 169, 171 (5th Cir. 1992)). 

57. Indeed, in certain situations, a “manufacturer [may] reasonably [] rely on an intermediary 

purchaser to warn ultimate users of dangers associated with the use of a product.” Baker 

v. Monsanto Co., 962 F. Supp. 1143, 1151 (S.D. Ind. 1997). Such a situation arises 

where “it would be impossible for a manufacturer to access all ultimate users of a product 

because it had no control over the site of usage.” Id. 

58. Because ECM’s customers were aware of the dangers associated with selling a 

“biodegradable” product, ECM had no duty to the end use consumer. Akin, 156 F.3d at 

1037; O’Neal, 10 F.3d at 251–52; Davis 975 F.2d at 171. This is particularly true where, 

as here, ECM’s customer audience was free and able to test the products themselves, 
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consult with legal counsel, and where ECM does not have access to all ultimate users of a 

product and has no control over the usage of its product. Baker, 962 F. Supp. at 1151. 

Complaint Counsel Did Not Satisfy their Burden that ECM’s Claims Regarding Rate of 

Biodegradation, Whether Express or Implied (if made at all), were Material to Either 

ECM’s Customers or to Consumers 

59. The FTC must also establish materiality of a misleading claim in order to prevail. “A 

‘material’ misrepresentation is one that involves information that is important to 

consumers, and is therefore likely to affect a consumer's choice of or conduct regarding a 

product.” F.T.C. v. Bronson Partners, LLC, 564 F. Supp. 2d 119, 135 (D. Conn. 2008) 

(quoting In Re Kraft, Inc., 114 F.T.C. 40 (1991)); see also FTC Policy Statement on 

Deception, Federal Trade Commission (1983)). 

60. In order to determine whether an advertisement is material, “[t]he basic question is 

whether the act or practice is likely to affect the consumer’s conduct or decision with 

regard to a product or service.” Cliffdale Assocs., Inc., 103 F.T.C. 110, at 45 (1984)). 

“In other words, [information that is material] is information that is important to 

consumers.” Id. at 49. “A claim is considered material if it involves information that is 

important to consumers and, hence, likely to affect their choice of, or conduct regarding a 

product.” Kraft, Inc. v. F.T.C., 970 F.2d 311, 322 (7th Cir. 1992) (internal quotations and 

citations omitted); see also F.T.C. v. Colgate-Palmolive Co., 380 U.S. 374, 391 (1965) 

(citing F.T.C. v. Raladam Co., 316 U.S. 149, 152 (1942)) (“when the Commission finds 

deception it is also authorized, within the bounds of reason, to infer that the deception 

will constitute a material factor in a purchaser's decision to buy”). 

61. The FTC applies a presumption of materiality to “(1) express claims; (2) implied claims 

where there is evidence that the seller intended to make the claim; and (3) claims that 
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significantly involve health, safety, or other areas with which reasonable consumers 

would be concerned.” Id. The first situation applies “[w]here the seller knew, or should 

have known, that an ordinary consumer would need omitted information to evaluate the 

product or service, or that the claim was false,” and, in such a circumstance, “materiality 

will be presumed because the manufacturer intended the information or omission to have 

an effect.” Cliffdale, 103 F.T.C. 110, *49. The second situation applies “when evidence 

exists that a seller intended to make an implied, the commission will infer materiality.” 

Id. The third situation can apply when the advertisement concerns information that 

“pertain[s] to the central characteristics of the product or service.” Id.

62. “A representation is material if likely relied upon by a reasonable prospective purchaser.” 

F.T.C. v. Wash Data Ress., 856 F. Supp. 2d 1247, 1272 (M.D. Fla. 2010). Importantly, 

“[r]ather than an isolated word, phrase, or sentence, the representations net impression 

controls.” Id. at 1272 (citations omitted). “What is important in determining whether a 

statement is misleading is the over-all impression it tends to create on the public.” 

Country Tweeds, Inc. v. F.T.C., 326 F.2d 144, 148 (2d Cir. 1964) (citing Murray Space 

Shoe Corp. v. F.T.C., 304 F.2d 270 (2d Cir. 1956)). 

63. A respondent can counter a presumption of materiality with extrinsic evidence. See In 

the Matter of Pom Wonderful LLC, 2012 WL 2340406 (F.T.C. May 17, 2012). As 

explained in POM Wonderful and Novartis: 

Respondent can present evidence that tends to disprove the 

predicate fact from which the presumption springs (e.g., that the 

claim did not involve a health issue) or evidence directly 

contradicting the initial presumption of materiality. This is not a 

high hurdle. Unless the rebuttal evidence is so strong that the fact 

finder could not reasonably find materiality, the fact finder next 

proceeds to weigh all of the evidence presented by the parties on 

the issue. See id. at 516 (noting that after the presumption drops 
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out, “the inquiry ... turns from the few generalized factors that 

establish [the presumption] to the specific proofs and rebuttals ... 

the parties have introduced”). 

Id. at *235. 

64. “Materiality turns upon whether those consumers who have drawn the claim from the 

advertisement and have been misled by it are also likely to have their conduct affected 

by the misrepresentation.” In re Novartis Corp., 127 F.T.C. 580, 691 (1999) (emphasis 

added). 

The Pfizer Factors Demonstrate That Biodegradable Claims Need Not Meet a High 

Standard of Competent and Reliable Evidence 

65. The FTC has the burden of showing that a particular claim was made without a 

reasonable basis. See FTC v. Braswell, 2005 WL 4227194 (C.D. Cal. Sept. 27, 2005); 

F.T.C. v. Medlab, Inc., 615 F. Supp. 2d 1068, 1079 (N.D. Cal. 2009); FTC v. Pantron I 

Corp., 33 F.3d 1088, 1096 (9th Cir.1994). In order to have a reasonable basis to make 

the claim at issue, an advertiser must possess “competent and reliable scientific evidence” 

to substantiate that claim. Sterling Drug, Inc. v. FTC, 741 F.2d 1146, 1156–57 (9th 

Cir.1984). 

66. The FTC has not defined what constitutes “competent and reliable scientific evidence” in 

the context of biodegradable advertising. The FTC is using this litigation to define what 

competent and reliable scientific evidence is in the context of biodegradable advertising. 

Consistent with precedent, FTC may not set a high reasonable basis standard comparable 

to that applied in the drug context in the absence of evidence that the claim affects human 

health. Thompson, 104 F.T.C. 648, at ¶¶ 71–72; see also POM, 2013 WL 268926, at *48 

(noting that the respondents “made claims regarding serious diseases”); In the Matter of 

Removatron Int’l Corp., 111 F.T.C. 206, at *14 n. 20 (Nov. 4, 1988) (noting that a drug 
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or product that directly affects human safety requires more substantiation). Rather, the 

FTC must look to what the industry accepts as a reasonable basis of proof in support of 

the claim. F.T.C. v. Nat’l Urological Grp., Inc., 645 F. Supp. 2d 1167, 1190 (N.D. Ga. 

2008) (quotation omitted) (“the FTC has defined competent and reliable scientific 

evidence as tests, analyses, research, studies, or other evidence based on the expertise of 

professionals in the relevant area, that have been conducted and evaluated in an objective 

manner by persons qualified to do so, using procedures generally accepted in the 

profession to yield accurate and reliable results”) (emphasis added). 

67. Fully protected speech of a technical or scientific nature may not be subjected to cease 

and desist orders or limitations on the prospective right to communicate unless the FTC 

possesses a compelling state interest, a means that is narrowly tailored to achieve the 

interest, and proof that its chosen means is the least restrictive alternative. See, e.g.,

Citizens United v. Fed. Election Comm'n, 558 U.S. 310, 340 (2010); Am. Civil Liberties 

Union v. Reno, 31 F. Supp. 2d 473, 493 (E.D. Pa. 1999). On this record, the FTC goal of 

eliminating consumer deception is not served through imposition of a cease and desist 

order that has the effect of burdening the right of ECM or the ability of ECM to 

communicate that its additive is biodegradable. C.f. Am. Civil Liberties Union v. 

Mukasey, 534 F.3d 181, 204 (3d Cir. 2008) (holding that the Child Online Protection Act 

(COPA), which criminalized transmission over the Internet, for commercial purposes, of 

material “harmful to minors,” was not least restrictive alternative to advance 

government’s compelling interest in protecting minors from exposure to sexually explicit 

material because available filtering technology, which Congress could promote and 
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support in place of COPA, was more effective at blocking sexually explicit material, and 

unlike COPA, did not chill speech). 

68. Commercial speech is speech involving an offer for sale of a product. United States v. 

United Foods, Inc., 533 U.S. 405, 409 (2001); Bd. of Trustees of State Univ. of N.Y. v. 

Fox, 492 U.S. 469, 473–74 (1989); Hunt v. City of L.A., 638 F.3d 703, 715 (9th Cir. 

2011). 

69. “The States and the Federal Government are free to prevent the dissemination of 

commercial speech that is false, deceptive, or misleading, or that proposes an illegal 

transaction. Commercial speech that is not false or deceptive and does not concern 

unlawful activities, however, may be restricted only in the service of a substantial 

governmental interest, and only through means that directly advance that interest.” 

Zauderer v. Office of Disciplinary Counsel of Supreme Ct. of Ohio, 471 U.S. 626, 637 

(1985) (citing Central Hudson, 447 U.S. at 566) (other internal citations omitted). 

70. “[C]ommercial speech is . . . constitutionally protected so long as it concerns lawful 

activity and is not misleading. . .” Kiser v. Reitz, 13-3956, 2014 WL 4211193 (6th Cir. 

Aug. 27, 2014). 

71. The government may not prospectively impose limitations or burdens on the right to 

communicate speech by requiring excessively high levels of supporting scientific 

evidence, and a claim may not be barred “simply because the scientific literature is 

inconclusive.” Pearson v. Thompson, 141 F. Supp. 2d 105, 110 (D.D.C. 2001). In 

addition, even if some studies show efficacy, the fact that other studies produce no such 

result does not justify suppression of that information. See Whitaker v. Thompson, 248 F. 

Supp. 2d 1, 13 (D.D.C. 2002) (where only one-third of the studies showed benefit and 
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were criticized as procedurally flawed, the court held that suppression of information was 

improper and where the court stated that because there was “some” evidence of efficacy, 

“a complete ban of the [c]laim cannot be justified”). 

72. Even assuming the information exchanged by ECM is commercial speech, because the 

speech at issue is, at worst, only potentially (and not inherently) misleading, it may not be 

burdened, prospectively limited, or constrained absent satisfaction of the intermediate 

scrutiny test stated in Central Hudson, 447 U.S. 557 (1980), and its progeny. Zauderer v. 

Office of Disciplinary Counsel of Supreme Ct. of Ohio, 471 U.S. 626, 638 (1985) 

(citations omitted) (“There is no longer any room to doubt that what has come to be 

known as “commercial speech” is entitled to the protection of the First Amendment, 

albeit to protection somewhat less extensive than that afforded “noncommercial 

speech.”). 

73. Under that test, FTC must have a substantial state interest, there must be a reasonable fit 

between the means chosen and the ends, the chosen regulation must directly and 

materially advance the chosen ends, and there must not be obvious less speech restrictive 

alternatives. Id. In this case, there is not a reasonable fit between a cease and desist 

order or fencing in provisions and advancement of the FTC’s interest in avoiding 

deceptive advertising, nor do such means directly and materially advance that interest, 

because imposition of proof requirements beyond the credible evidence already 

supporting ECM’s biodegradation claim impairs communication between ECM and its 

customers about the primary characteristic of the ECM additive in a manner 

indistinguishable from a prior restraint. Moreover, there are obvious, less speech 

restrictive alternatives that directly advance the FTC’s interest, such as a claim 
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qualification that rates of biodegradation vary based on environmental conditions at the 

location where the plastic is disposed. See Fla. Bar v. Went For It, Inc., 515 U.S. 618, 

632 (1995) (quoting Cincinnati v. Disc. Network, Inc., 507 U.S. 410, 417 n. 13 (1993)) 

(noting that “the existence of ‘numerous and obvious less-burdensome alternatives to the 

restriction on commercial speech ... is certainly a relevant consideration in determining 

whether the ‘fit’ between ends and means is reasonable’”). 

74. Lesser constitutional protection is warranted for statements “made only in the context of 

commercial transactions,” because businesses “enjoy the full panoply of First 

Amendment protections for their direct comments on public issues.” Central Hudson 

Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557, 562 n. 5 

(1980); Bolger v. Youngs Drug Products Corp., 463 U.S. 60, 68(1983); Zauderer v. 

Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626, 637-38 n. 7 

(1985). 

75. Based on the Pfizer factors outlined below, the standard to be applied in this case must be 

lower than standards applied in other FTC proceedings considering advertisements 

related to medical or health claims. For example, in the medical context, advertising 

claims must be substantiated by double-blind, randomized, placebo-controlled clinical 

trials. Thompson Med. Co., Inc. v. Fed. Trade Comm'n, 791 F.2d 189 (D.C.Cir.1986); 

Bristol-Myers Co. v. Fed. Trade Comm'n, 738 F.2d 554 (2d Cir.1984). 

76. Similarly, the standard to apply in this case must necessarily be lower than the standard 

for advertising claims related to food products which purport to have health benefits—

“one well designed, randomized, and double-blind, placebo-controlled clinical trial 
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involving an appropriate sample population and endpoint.” POM, 2013 WL 268926, at 

*43. 

77. While those standards obviously cannot apply to biodegradability, they are important 

benchmarks to demonstrate that ECM’s “competent and reliable scientific evidence” need 

not be as high as that mandated in Thompson, Bristol-Myers, and POM. See Statement of 

Commissioner Ohlhausen, 2014 WL 587857, at *1 (F.T.C. Jan. 7, 2014) (“[T]he burden 

for substantiation for health- or disease-related claims about a safe product . . . should be 

lower than the burdens imposed on drugs and biologics because consumers face lower 

risks when consuming the safe product.”). Of course, the burden for substantiation for 

biodegradation related claim should be lower than the burdens imposed on health and 

disease related because consumers face no risk when deciding to obtain a product labeled 

as biodegradable. 

78. To help determine what constitutes “competent and reliable scientific evidence,” the FTC 

has recognized two types of claims: establishment and non-establishment claims. See

Thompson Med. Co., Inc. v. F.T.C., 791 F.2d 189, 194 (D.C. Cir. 1986). Establishment 

claims contain express or implied representations about the level of support for a 

particular claim (i.e., the claim states that a product has been found to be superior by 

scientific tests). Id. For such claims, the advertiser must possess the level of proof 

claimed in the ad. Id. 

79. By contrast, a non-establishment claim is a simple claim of efficacy. Id. A simple claim 

that a product is “biodegradable” is a claim of efficacy and therefore a non-establishment 

claim. 
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80. For such non-establishment claims, “the reasonable basis inquiry has been defined more 

flexibly.” Id. This standard is a “flexible standard” that calls for an evaluation of a 

variety of factors suited to the particular case at hand. Direct Mktg. Concepts, Inc. v. 

F.T.C., 581 F. Supp. 2d 115, 118 (D. Mass. 2008). Therefore, the Commission’s 

“reasonable basis cases have identified several factors that [the Commission] will weigh 

in determining the appropriate level of substantiation for objective advertising claims.” 

In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648, at ¶ 70 (Nov. 23, 1984). 

81. The relevant factors are: “(1) the product involved; (2) the type of claim; (3) the benefits 

of a truthful claim; (4) the ease of developing substantiation for the claim; (5) the 

consequences of a false claim; and 6) the amount of substantiation experts in the field 

would agree is reasonable.” Id. These factors are used to weigh the benefits and costs of 

developing substantiation for the claim. In the Matter of POM Wonderful LLC, 2013 WL 

268926, at *30 (F.T.C. Jan. 16, 2013).3

 The level of proof required to meet the Pfizer test 

in this case is significantly reduced because all of the Pfizer factors favor a more relaxed 

standard. 

The Nature of the Product Involved

82. Regarding the first factor, the product involved, the Commission has made clear that 

products like drugs—which improve physical welfare—as opposed to products that do 

not purport to improve physical welfare, “require[] a relatively high level of 

substantiation.” Thompson, 104 F.T.C. 648, at ¶¶ 71–72; see also POM, 2013 WL 

                                                             3

 ECM has not made any “establishment” claims to end-consumers. To ECM’s 

sophisticated manufacturing customers, it has disclosed the types of tests shown to have resulted 

in biodegradation. To the extent ECM’s disclosure of its test data and names of test standards is 

an establishment claim, the claim is truthful and non-misleading. ECM does possess the tests its 

claims to have, and those tests do show that ECM’s technology creates a biodegradable plastic. 
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268926, at *48 (noting that the respondents “made claims regarding serious diseases”); In 

the Matter of Removatron Int’l Corp., 111 F.T.C. 206, at *14 at n. 20 (Nov. 4, 1988) 

(noting that a drug or product that directly affects human safety requires more 

substantiation). 

83. ECM does not market products like drugs, foods, medical devices, or dietary supplements 

that improve physical welfare. ECM has not made claims concerning serious diseases or 

health conditions. Moreover, significantly, ECM has never sold product to endconsumers. ECM sells a plastic additive to plastics manufacturers that, when 

manufactured correctly, will help render the finished plastic biodegradable in a landfill 

over time. 

84. The first Pfizer factor weighs in favor of a finding that ECM has presented sufficient 

substantiation for its biodegradable claims. 

The Type of Claims Made 

85. The second factor is the type of claim being made. One type of claim that requires a high 

a level of substantiation “is a claim that refers to specific facts or figures, rather than 

making generalized descriptions of the product’s capabilities.” Thompson, 104 F.T.C. 

648, at ¶ 72. 

86. Therefore, a generalized claim, such as “biodegradable,” would require a lower level of 

substantiation than a more specific claim. 

87. The Second Pfizer factor weighs in favor of a finding that ECM has presented sufficient 

substantiation for its biodegradable claims. 
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The Benefits of a Truthful Claim and Ease of Developing Substantiation for the Claims

88. The third and fourth factors are often considered “in conjunction with each other.” Id. at 

¶ 74. The Commission’s “concern in analyzing these factors is to ensure that the level of 

substantiation [the Commission] require[s] is not likely to prevent consumers from being 

told potentially valuable information about product characteristics.” Id.; see also 

Removatron, 111 F.T.C. 206 at n. 20 (“These two factors together seek to ensure that the 

level of substantiation we require is not likely to deter product development or prevent 

consumers from being told potentially valuable information about product 

characteristics”). 

89. Consumers can be prevented from being told potentially valuable information about 

product characteristics when the cost of developing substantiation for these claims would 

be high in comparison to the amount of sales the product can earn. Id. at ¶¶ 74–75. So, 

the Commission will not require substantiation that, because of its prohibitive costs, will 

become non-feasible. POM, 2013 WL 268926, at *49. 

90. The third and fourth Pfizer factors weigh in favor of a finding that ECM has presented 

sufficient substantiation for its biodegradable claims. 

The Consequences of a False Claim 

91. Under the fifth factor, the consequences of a false claim can be divided into either health 

or economic consequences. See Thompson, 104 F.T.C. 648, at ¶¶75–76 (noting that false 

claims can be “injurious to health and economically harmful”). 

92. In order to be economically harmful, the economic harm suffered by consumers must be 

“material” and “substantial.” See POM, 2013 WL 268926, at *50, n. 31 (noting that a 
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one year supply of the POM Juice costs at least $780); Removatron, 111 F.T.C. 206 at n. 

20 (noting that the device at issue cost approximately $4,000, and required treatments 

that cost $35 per hour over a period of years). 

93. The fifth Pfizer factor weighs in favor of a finding that ECM has presented sufficient 

substantiation for its biodegradable claims. 

The Amount of Substantiation Experts in the Field Agree Is Reasonable

94. The final factor is the amount of substantiation experts in the field agree is reasonable. 

This factor “must be examined in relation to each field being evaluated.” POM, 2012 

WL 2340406, at *206. 

95. The sixth Pfizer factor weighs in favor of a finding that ECM has presented sufficient 

substantiation for its biodegradable claims.

COMPLAINT COUNSEL’S DEFINITION OF BIODEGRADATION IS ARBITRARY 

AND CAPRICOUS 

96. A court should “hold unlawful and set aside agency action, findings, and conclusions 

found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance 

with law.” 5 U.S.C. § 706. 

97. An agency's decision is arbitrary and capricious when the agency “entirely failed to 

consider an important aspect of the problem, offered an explanation for its decision that 

runs counter to the evidence before the agency, or is so implausible that it could not be 

ascribed to a difference in view or the product of agency expertise.” Motor Vehicle 

Manufacturers Association v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29 

(1983). 

98. Review of agency action is “not merely perfunctory,” the review should be a ‘searching 

and careful’ inquiry.’” Int’l Ladies' Garment Workers' Union v. Donovan, 722 F.2d 795 
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(D.C. Cir. 1983); Specialty Equip. Mkt. Ass’n v. Ruckelshaus, 720 F.2d 124, 132 (D.C. 

Cir. 1983) (“when reviewing agency's determinations under "arbitrary and capricious" 

standard, "we must make a substantial and searching inquiry to ensure that the agency's 

decisions are the product of reasoned thought and based upon a consideration of relevant 

factors”); Dickinson v. Zurko, 527 U.S. 150, 155 (1999) (“[t]he APA requires meaningful 

review; and its enactment meant stricter judicial review of agency fact finding than 

Congress believed some courts had previously conducted”). 

99. As applied to the ECM plastic here in issue, the One-Year Rule is arbitrary and 

capricious and lacking in any reasonable factual basis. Reliance upon it as a rule of 

decision would therefore be an abuse of agency discretion. See Motor Vehicle Mfrs. 

Ass’n v. State Farm Mut. Ins. Co., 463 U.S. 29, 43 (1983) (explaining that an agency 

abuses its discretion when its explanation runs counter to the evidence before the 

agency). 

COMPLAINT COUNSEL’S PRIMARY SCIENTIFIC EXPERT WITNESS HAS A 

DIRECT FINANCIAL INTEREST IN THE OUTCOME OF THIS LITIGATION AND 

HAS TAKEN INCONSISTENT POSITIONS THROUGHOUT THIS CASE; HIS 

OPINION SHOULD THEREFORE BE GIVEN NO WEIGHT. 

100. Expert witness testimony can be rebutted by evidence of the expert’s direct financial 

interest in the outcome of the litigation or by inconsistencies in the expert’s testimony. 

Mims v. U.S., 375 F.2d 135, 134–35 (5th Cir. 1967) (noting that [i]t has been recognized 

that expert opinion evidence may be rebutted by ... the interest or bias of the expert [] or 

inconsistences in his testimony as to material matters”) 

101. Where an expert witness has a direct financial interest in the outcome of the litigation, 

that expert witness’s opinion should be given no weight. Western Assur. Co. Inc. v. 
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Connors, 101 F. Supp. 2d 1111, 1116 (S.D. Ind. 1999) (giving no weight to expert 

opinion where expert had financial incentive in the outcome of the case). 

102. In FTC proceedings, credibility is always in issue. Chappell, Tr. 1526, 1706. It is for the 

judge to make character findings in instances where testimony, particularly of experts, is 

evasive, false, misleading, or perjurious. Cota v. Tucson Police Dep’t, 783 F. Supp. 458, 

464 (D. Ariz. 1992) (“When sitting as a finder of fact, a trial judge necessarily determines 

the credibility of expert witnesses.”). 

103. “[T]he nature and extent of a witness’s motives and his interest in the outcome of the case 

bear importantly upon an evaluation of the witness’s objectivity, his bias, and the weight 

to be accorded his testimony.” United States v. IBM Corp., 66 F.R.D. 215, 219 

(S.D.N.Y. 1974); Nemir v. Mitsubishi Motors Corp., 200 F.Supp.2d 770, 774 (E.D. MI 

2002) (“The more subjective and controversial the expert's inquiry, the more likely the 

testimony should be excluded as unreliable.”). 

A SURVEY MUST MEET STANDARDS IN ORDER TO BE CONSIDERED BY THE 

FTC OR ANY OTHER COURT OF LAW 

104. “[A] party seeking to admit survey evidence must show that the survey was conducted 

according to accepted principles.” Clicks Billiards, Inc. v. Sixshooters Inc., 251 F.3d 

1252, 1262 (9th Cir. 2001). 

105. Factors the FTC takes into account when determining whether to afford a survey any 

weight include whether the survey was performed in the usual manner for surveys of that 

type, whether the survey employed controls and validation procedures, whether the 

samples were reasonably representative, whether the respondents to the survey actually 

understood the questions being asked, and whether the respondent has sufficient 

experience with the product involved in the survey. In re Littelton Indus., Inc., 97 F.T.C. 
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1, at ¶¶ 69–73 (Jan. 5, 1981); In the Matter of Bristol-Myers, 85 F.T.C. 688 at n. 14 (Apr. 

22, 1975). 

COMPLAINT COUNSEL’S ENFORCMENT ACTION AGAINST ECM IS NOT IN THE 

PUBLIC INTEREST 

106. As a prerequisite to enforcement action, the Commission must determine whether there is 

a reason to believe that an unfair method of competition is being used, that the 

proceeding would be in the public interest, and that such interest is specific and 

substantial. See Federal Trade Commission v. Raladam Co., 283 U.S. 643 (1931). 

107. A proceeding by the Commission to prevent the use of unfair methods or unfair or 

deceptive acts or practices must appear to be in the interest of the public. Thomas v. 

FTC, 116 F.2d 347, 349 (10th Cir. 1940). 

108. In fact, the “commission is authorized to act only in the public interest, and to justify it in 

filing a complaint that public interest must be specific and substantial.” Arnold Stone Co. 

v. FTC, 49 F.2d 1017, 1019 (5th Cir. 1931). 

109. The “mere misrepresentation and confusion or deception of purchasers” is insufficient for 

FTC action. FTC v. Royal Milling Co., 288 U.S. 212, 216 (1933). 

110. FTC precedent establishes that where a sophisticated entity, and not a consumer, makes 

the decision whether to purchase the product at issue from a respondent, the respondent’s 

claims regarding that product cannot have any influence on the consumers, and therefore 

the public interest is not served by requiring corrective action. In the Matter of Charles 

F. Harad, 50 F.T.C. 300, 315–316 (1953). 

111. In Harad, the respondent claimed in a trade magazine that its product will be beneficial 

following patient surgeries or after specific medical treatment. Id. at 315. The experts in 

that case disagreed over whether or not the product was actually beneficial. Id. 
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112. However, the hearing examiner found “it unnecessary to resolve th[at] difference of 

opinion.” Id. The court first noted that because it was the physician’s decision whether 

or not to purchase the device, the respondent’s claim could not have “any significant 

influence on the[] patients.” Id. 

113. In recommending dismissal of the complaint, the court then went on to state: 

In any event, since the representation made with respect to the ... 

use of the device was concededly made in a publication intended 

for circulation among physicians only, who, it can be assumed, 

will not be misled by anything respondents might say regarding 

their product, and since there is no substantial evidence that the 

general consuming public would be misled thereby, it is the 

opinion of the undersigned that the public interest does not require 

the taking of any corrective action based on the alleged falsity of 

any representation that respondents’ device may be used postoperation or post-injection. 

Id. at 315–16 (contrasting Irwin v. F.T.C., 143 F.2d 316 (8th Cir. 1944)) (where the respondent 

made claims regarding its product in “periodicals and by booklets, pamphlets, circulars, letters, 

and other advertising material”). 

114. Just like in Harod, it is undisputed that ECM did not market its product directly to 

consumers. Rather, ECM, like the respondent in Harod, made claims to entities 

interested in purchasing the product for commercial and not personal use, namely plastic 

manufactures. Whether or not to purchase the ECM additive is a decision left entirely to 

the plastic manufacturers that actually purchases the ECM additive. Like physicians 

determining whether or not to purchase a controversial medical device, plastic 

manufacturers cannot be misled by any marketing claims regarding additives used in the 

manufacture of plastics, which is their specific profession and area of expertise. 
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115. Therefore, “the public interest does not require the taking of any corrective action based 

on the alleged falsity of any representation that” that ECM made only to plastic 

manufacturers. Harad, 50 F.T.C. at 316. 

116. The public interest is not served by having the Federal Trade Commission wade into 

areas of unsettled and complex science where the debate within industry and academia 

has yet to be resolved. See Koch v. FTC, 206 F.2d 311 (6th Cir. 1953). (“A principal test 

as to whether a particular case affects the public interest is whether the misleading or 

deception of the public is shown”). Here, there is no evidence that the public have been 

misled. 

117. In Arnold Stone, the Court held that action was not in the public interest or misleading 

because the FTC had failed to produce any evidence showing that a stone company’s use 

of the word “stone” deceived any of their sophisticated customers, even though the 

“stone” products sold were actually made of composite materials like concrete. Arnold 

Stone, 49 F.2d at 1018-19. 

118. Significant to this case, the Court explained that “none of the words employed by the 

petitioner to describe any of its manufactured products or materials had the effect of 

misleading or deceiving architects, contractors, or builders who were the only classes of 

persons to whom petitioner sold or offered to sell any such products or materials.” Id.

The Court continued, “[t]he sum and substance of all the evidence was that the words 

‘cast stone’ were understood by petitioner’s prospective customers and by its competitors 

to mean just such a product as petitioner manufactured and sold.” Id. 

119. In addition, “there must be a showing that the acts and practices sought to be proscribed 

are detrimental to the public interest in order to satisfy the statutory requirement that the 
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proceeding be in the public interest.” S. Buchsbaum & Co. v. FTC, 160 F. 2d 121, 123-

24 (7th Cir. 1947). 

120. That fact was dispositive in the Buchsbaum case, as the Court explained: 

[T]he Commission made no finding that the deception, if any, had 

ever resulted in or had any tendency to result in detriment to the 

purchasing public. We find nothing in the findings to support the 

conclusion that the acts and practices are all to the prejudice and 

injury of the public. 

Id. at 123-24. 

121. This ECM case is similar to Buchsbaum, where the FTC challenged a company making 

shatterproof “glass” products because, according to the FTC, the “glass” was actually 

made out of plastic. Id. at 123. The Court observed that, just like in this case where 

ECM can undercut the prices of the more expensive bioplastics: 

It is quite evident that [the] proceeding was actuated by the 

manufacturers of [competing] glass as contained in window panes, 

tumblers and the like. The trouble arises in trying to compete with 

petition in the sale of the same articles made of ‘Elasti-Grass’ by 

petition. Thus far, it appears from the record, the competition has 

not been successful for such manufacturers, because of the cheaper 

prices of petitioner’s products. 

Id. at 124. 

122. The ECM case is not materially different from Buchsbaum. Complaint Counsel alleges 

that the word “biodegradable” has a specific meaning (just like “glass” had a meaning in 

Buchsbaum), and that customers will be misled into thinking the “biodegradable” plastic 

is of a specific kind, to wit, a kind that rapidly degrades. In Buchsbaum the court rejected 

this very type of case for the same reason the Administrative Law Judge should deny 

Complaint Counsel its requested relief: “We find in this record no evidence of any injury 

to any dissatisfied customer, indeed, there are no dissatisfied customers so far as this 
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record discloses.” Id. at 123. The Court also wisely acknowledged that any theorized 

injury could be alleviated through a more proactive consumer: 

It is intimated that the injury will occur to those who have been 

‘long accustomed to the worth and use of glass.’ If this class of 

customers would consult their lexicons and inform the merchants 

as to the kind of glass they desire they will never be misled. 

Certainly they cannot be misled or injured by petitioner’s 

advertisements. 

Id. at 123. 

123. As the precedent makes clear, Complaint Counsel is obliged to identify some tangible or 

palpable injury in the market in order to establish that this case is in the public interest. 

They have not done so, and they cannot do so on this record. 

COMPLAINT COUNSEL’S CENSORSHIP OF “BIODEGRADABLE” CLAIMS 

VIOLATES THE FIRST AMENDMENT 

124. First Amendment protections directly apply to FTC orders and limit the expansion of 

FTC advertising regulation. See, e.g., Standard Oil C. of California v. F.T.C., 577 F.2d 

653, 662 (9th Cir. 1978) (“First Amendment considerations dictate that the Commission 

exercise restraint in formulating remedial orders which may amount to a prior restraint on 

protected commercial speech”); Sears, Roebuck and Co. v. F.T.C., 76 F2d 385, 399 n.31 

(9th Cir. 1982); Beneficial Corp, 542 F.2d at 611; F.T.C. v. Simeon Management Corp., 

532 F.2d 708, 713 (1976) (“[a]lthough commercial advertising may be subject to 

regulation serving an important public interest, it is not beyond the protection of the First 

Amendment”). 

125. The Constitution prohibits restriction of potentially misleading speech when there are 

obvious, less speech restrictive alternatives to imposing prospective speech burdens. See, 

Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999). 
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126. A burden on speech need not be a complete prior restraint in order to compel 

constitutional assessment under the commercial speech standard. See, e.g., Alliance for 

Natural Health U.S. v. Sebelius, 786 F. Supp. 2d 1, 24 (D.D.C. 2011) (“the FDA cannot 

require a disclaimer that simply swallows the claim . . .”). 

127. A cease and desist order that either prohibited use of the term “biodegradable” unless 

more than the credible evidence in this record was prospectively produced or unless 

confined to the impossible (such as a set rate within one year, despite the impossibility of 

reliably achieving same, or such as a demand for 100% break down of the plastic into 

elements in nature, despite the fact that science proves biodegradation of plastics 

inevitably leaves residues that still contain elements of plastic) would violate both the 

“reasonable fit” prong of the commercial speech test and the “obvious, less speech 

restrictive alternative” prong. See, e.g., City of Cincinnati v. Discovery Network, Inc., 

507 U.S. 410, 417 (1993) (holding that ban on news racks containing “commercial 

handbills,” which did not apply to news racks containing “newspapers” was not a 

“reasonable fit” between city’s legitimate interest in safety and esthetics and means 

chosen to serve interest); Western States Medical Center, 535 U.S. 357, 371 (2002) 

(explaining that the Court has “in previous cases addressing this final prong of the 

Central Hudson test, . . . made clear that if the Government could achieve its interests in 

a manner that does not restrict speech, or that restricts less speech, the Government must 

do so”). 

128. In particular, a cease and desist order that prohibits commercial speech that is backed by 

credible evidence on the demand that more evidence exist before government will allow 

the claim is a burden on speech already held unconstitutional by our Court of Appeals in 
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Pearson v. Shalala and its progeny (and that, in a public health context). See, e.g., ANH, 

786 F. Supp. 2d at 24 (“Where the evidence supporting a [health] claim is inconclusive, 

the First Amendment permits the claim to be made . . .”). 

129. In Pearson I, the D.C. Circuit held that perceived deficiencies in the scientific record 

must be proven incapable of being rendered non-misleading by resort to reasonable claim 

qualifications before the government may burden speech with a prospective speech ban. 

See Pearson I, 164 F.3d at 658 (holding that “[i]t is clear ... that when government 

chooses a policy of suppression over disclosure—at least where there is no showing that 

disclosure would not suffice to cure misleadingness—government disregards a ‘far less 

restrictive’ means”); see also Whitaker v. Thompson, 248 F.Supp. 2d 1 (D.D.C. 2002); 

Alliance for Natural Health U.S. v. Sebelius, 714 F.Supp. 2d 48, 53 (D.D.C. 2010) (“ANH 

I”); Alliance for Natural Health U.S. v. Sebelius, 786 F.Supp. 2d 1, 8 (D.D.C. 2011) 

(“ANH II”). The same law and logic applies to FTC orders that restrain future speech 

through cease and desist and fencing in orders or other burdens. 

130. A government mandated claim qualification is constitutional only if it is reasonable. See, 

e.g. Whitaker v. Thompson, 248 F. Supp. 2d 1, 2 (D.D.C. 2002) (enjoining FDA from 

taking any action that would prevent the use of the antioxidant vitamin health claim at 

issue as proffered or with reasonable disclaimers). 

131. Although the government may have an interest in protecting consumers from misleading 

claims, that interest cannot overcome the First Amendment’s preference for disclosure 

(compelled or voluntary) over suppression when claim qualification is a suitable, less 

speech-restrictive alternative. See Whitaker, 248 F. Supp. 2d at 10. As in this case, when 

“credible evidence supports a claim, that claim may not be absolutely prohibited.” See 
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id. (citing Pearson I, 164 F.3d at 659). Moreover, significantly, “[t]he mere absence of 

significant affirmative evidence in support of a particular claim ... does not translate into 

negative evidence against it.” Pearson v. Shalala, 130 F.Supp. 2d 105, 115 (D.D.C. 

2001) (“Pearson II”); Edenfield v. Fane, 507 U.S. 761, 770 (1993) (“[I]t is well 

established that the party seeking to uphold a restriction on commercial speech carries the 

burden of justifying it”). 

132. Moreover, significantly, “[t]he mere absence of significant affirmative evidence in 

support of a particular claim ... does not translate into negative evidence against it.” 

Pearson v. Shalala, 130 F.Supp. 2d 105, 115 (D.D.C. 2001) (“Pearson II”); Edenfield v. 

Fane, 507 U.S. 761, 770 (1993) (“[I]t is well established that the party seeking to uphold 

a restriction on commercial speech carries the burden of justifying it”). 

133. A limitation on the use of a broad, but scientifically accepted, definition of 

“biodegradable” must comply with the First Amendment commercial speech doctrine as 

articulated in Pearson I.

THE FTC’S PROSECUTION OF ECM IS ULTRA VIRES BECAUSE FTC IS 

ASSUMING REGULATORY POWER VESTED BY CONGRESS IN THE EPA 

134. Government action is ultra vires if the agency or other government entity “is not doing 

the business which the sovereign has empowered him to do or he is doing it in a way 

which the sovereign has forbidden.” Ancient Coin Collectors Guild v. U.S. Customs & 

Border Prot., Dep't of Homeland Sec., 698 F.3d 171, 179 (4th Cir. 2012) (quoting Larson 

v. Domestic & Foreign Commerce Corp., 337 U.S. 682, 689 (1949)). 

135. Courts review ultra vires agency action when an agency “patently misconstrues a statute, 

disregards a specific and unambiguous statutory directive, or violates a specific command 

of a statute.” Hunter v. F.E.R.C., 569 F. Supp. 12, 16–17 (D.D.C. 2008). Put differently, 
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“[a]n ultra vires act is one performed without any authority to act...” Sahaviriya Steel 

Indus. Public Co. Ltd. v. U.S., 601 F. Supp. 2d 1355, 1366 (C.I.T. 2009). The APA 

further contemplates that agency action is void if found to be “in excess of statutory 

jurisdiction, authority, or limitations, or short of statutory right.” See 5 U.S.C. § 706 

(2)(C). 

136. The U.S. EPA has primary responsibility for enforcing the environmental statutes and 

regulations of the United States. Under the federal Resource Conservation and Recovery 

Act (RCRA), Congress delegated to the EPA the task of managing solid waste disposal. 

See, e.g., 42 U.S.C. § 6901. Congress passed the RCRA, in part, to address the “evermounting increase ... of the mass material discarded by the purchaser of ... products.” 

42 U.S.C. § 6901(a)(1). Moreover, with respect to energy, Congress explained that 

“solid waste represents a potential source of solid fuel, oil, or gas that can be converted 

into energy.” 42 U.S.C. § 6901(d)(1). 

137. Complaints Counsel’s definition of “biodegradable,” which limits the naked term to 

products that degrade completely into elements found in nature within one year after 

customary disposal, is patently arbitrary and capricious and in conflict with 

environmental policies set by the federal Environmental Protection Agency. 

THE “ONE-YEAR” RULE IS AN INDUSTRY-WIDE TRADE REGULATION 

UNLAWFULLY PROMULGATED 

138. The “One-Year” Rule promulgated in the 2012 revision of the Green Guides is not an 

interpretative, non-binding statement of policy, but an industry-wide rule that redefines 

the kind and scope of products that can be marketed. 16 C.F.R.§ 260(V). The rule 

inherently favors short-term degradable products to the prejudice of those products that 
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would biodegrade slowly in a landfill, but still within a reasonably short period of time 

compared to conventional plastics. 16 CFR §§ 260.7–260.8. 

139. Furthermore, because Complaint Counsel has explained through this proceeding that no 

test can accurately substantiate the time for disposal in an MSW landfill, and the rule 

expressly states that it is “deceptive to make an unqualified degradable claim for items 

entering the solid waste stream if the items do not completely decompose within one year 

after customary disposal,” the Green Guides prohibit technologies that do not, in fact, 

disappear in landfills within one year. See 16 C.F.R. § 260.8(c). In other words, the 

Commission has condemned the use of landfill-able technologies in toto. That is an 

environmental policy that declares landfill-able products undesirable—not a position with 

respect to consumer deception. The FTC has thus enacted a new industry-wide rule 

without complying with the requirements of 15 U.S.C. § 57. 

140. 15 U.S.C. § 57 requires that FTC proceed through Magnuson-Moss rulemaking when 

promulgating rules defining practices which are unfair or deceptive. See 15 U.S.C. § 57a 

(requiring heightened procedural safeguards in FTC rulemaking proceedings); see also 5 

U.S.C. § 553 (requiring federal agencies, with limited exceptions, to follow notice-andcomment rulemaking procedures when promulgating a new rule, regulation, or 

interpretation of a regulation). Because the Commission has not complied with all of the 

requirements of Section 57a (in particular, provide an informal hearing under 15 U.S.C. § 

57a(c), and submit notice to the Committee on Commerce, Science, and Transportation 

of the Senate and to the Committee on Energy and Commerce of the House of 
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Representatives under 15 U.S.C. § 57a(b)(B)), the trade regulation rule implemented and 

now enforced against ECM is invalid and should be given no weight in this proceeding.4

141. The FTC has thus enacted a new industry-wide rule equivalent to the FDA’s prior 

restraint the United States Court of Appeals condemned as unconstitutional in Pearson I. 

See Pearson I, 164 F.3d at 655–60. 

THIS FTC PROCEEDING VIOLATES THE SEPARATION OF FUNCTIONS 

DOCTRINE 

142. Due Process is required in administrative proceedings. See Withrow v. Larkin, 421 U.S. 

35, 46 (1975); Utica Packing Co. v. Block, 781 F.2d 71, 76 (6th Cir. 1986). 

143. Under 5 U.S.C. § 556 of the Administrative Procedures Act, Congress requires 

administrative agencies to conduct hearings mandatory under §§ 553 and 554 “in an 

impartial manner.” 5 U.S.C. § 556. “A fair trial in a fair tribunal is a basic requirement 

of due process. Fairness of course requires an absence of actual bias in the trial of cases. 

But our system of law has always endeavored to prevent even the probability of 

unfairness." In re Murchison, 349 U.S. 133 (1955). As the D.C. Circuit has stated: “With 

regard to judicial decision making, whether by court or agency, the appearance of bias or 

pressure may be no less objectionable than the reality.” D.C. Federation of Civic Ass'ns 

v. Volpe, 459 F.2d 1231, 1246–47 (D.C. Cir. 1971), cert. denied, 405 U.S. 1030 (1972). 

144. “When governmental agencies adjudicate or make binding determinations which directly 

affect the legal rights of individuals, it is imperative that those agencies use the 

                                                             4

 For example, because the FTC did not properly characterize the industry rule as a Trade 

Regulation Rule under Section 57a, the Commission did not apparently notify and seek input 

from the Committee on Commerce, Science, and Transportation of the Senate and the 

Committee on Energy and Commerce of the House of Representatives. See 15 U.S.C. § 57a(2). 
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procedures which have traditionally been associated with the judicial process.” Utica 

Packing, 781 F.2d at 78. 

145. In administrative proceedings, “the requirement of a fair trial before a fair tribunal has 

not been eliminated. This concept requires the appearance of fairness and the absence of 

a probability of outside influences on the adjudicator; it does not require proof of actual 

partiality.” Id. at 76 (citing Withrow, 421 U.S. at 35). 

146. In order to enforce separation of functions and impartiality in administrative hearings, 

Congress included 5 U.S.C. § 554(d) in the APA. That statute restricts the 

investigator/prosecutor from being involved in the decision making process. “The clear 

purpose of [5 U.S.C. § 554(d)] is to separate the investigative and prosecutorial functions 

from the adjudicative function” in administrative hearings. Utica Packing, 781 F.2d at 76

(citing Wong Yang Sung v. McGrath, 339 U.S. 33, 41 (1950)). 5 U.S.C. § 556(d) cannot 

be read narrowly. Id. 

147. While the Commission is obligated to acknowledge the ALJ’s findings, there is no 

requirement that the Commission credit those findings or give them any weight. The 

Commission brought the allegations against ECM and will be the ultimate adjudicator 

against ECM. Thus, the Commission necessarily has an interest in the outcome sufficient 

to violate the doctrine of separation of functions. See Leer Elec., Inc. v. Penn. Dep’t of 

Labor and Indus., 597 F. Supp. 2d 470, 481 (M.D. Pa. 2009) (noting that the officials’ 

multiple roles as investigators, prosecutors, and adjudicators were sufficient to present a 

risk of actual bias). 

148. Due process affords parties the right to introduce certain evidence. See Chambers v. 

Mississippi, 410 U.S. 284 (1973); Epstein v. MCA , Inc., 54 F.3d 1422 (9th Cir. 1995) 
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(the federal rules ordinarily contemplate a “broad right of discovery”); Berger v. United 

States, 295 U.S. 78, 88 (1935) (“[The Government] is the representative not of an 

ordinary party ... but of a sovereignty ... whose interest is not that it shall win cases, but 

that justice be done”) (emphasis original). 

149. Where information from persons not present at hearing concerns an important issue in 

dispute, a due process objection may well be valid. See, e.g., Prebble v. Brodrick, 535 

F.2d 605, 616 (10th Cir. 1976). 

150. Fair rebuttal testimony is only “that which is precisely directed to rebutting new matter or 

new theories presented by the defendant’s case-in-chief.” Bowman v. Gen. Motros Co., 

427 F.Supp. 234, 240 (E.D. Pa. 1977) (emphasis added). 

Respectfully submitted, 

/s/ Jonathan W. Emord 

 Jonathan W. Emord 

 Peter A. Arhangelsky 

 Bethany R. Kennedy 

 Eric J. Awerbuch 

 EMORD & ASSOCIATES, P.C. 

 Telephone: 202-466-6937 

 Fax: 202-466-6938 

 Email: jemord@emord.com 

DATED: September 25, 2014 

 
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CERTIFICATE OF SERVICE 

I hereby certify that on September 25, 2014, I caused a true and correct copy of the 

foregoing to be served as follows: 

One electronic copy to the Office of the Secretary through the e-filing system: 

Donald S. Clark, Secretary 

Federal Trade Commission 

600 Pennsylvania Ave., NW, Room H-113 

Washington, DC 20580 

Email: secretary@ftc.gov 

One electronic courtesy copy to the Office of the Administrative Law Judge: 

The Honorable D. Michael Chappell 

Administrative Law Judge 

600 Pennsylvania Ave., NW, Room H-110 

Washington, DC 20580 

One electronic copy to Counsel for Complainant: 

Katherine Johnson 

Division of Enforcement 

Bureau of Consumer Protection 

Federal Trade Commission 

600 Pennsylvania Avenue, NW 

Mail stop M-8102B 

Washington, D.C. 20580 

Email: kjohnson3@ftc.gov 

Arturo Decastro 

Division of Enfoncement 

Bureau of Consumer Protection 

Federal Trade Commission 

600 Pennsylvania Avenue, NW 

Mail stop M-8102B 

Washington, D.C. 20580 

Email: adecastro@ftc.gov 

Jonathan Cohen 

Division of Enforcement 

Bureau of Consumer Protection 

Federal Trade Commission 

600 Pennsylvania Avenue, NW 

Mail stop M-8102B 

Washington, D.C. 20580 

Email: jcohen2@ftc.gov 

I certify that I retain a paper copy of the signed original of the foregoing document that is 

available for review by the parties and adjudicator consistent with the Commission’s Rules. 

 
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 Respectfully submitted, 

 

 Jonathan W. Emord (jemord@emord.com) 

 EMORD & ASSOCIATES, P.C. 

 11808 Wolf Run Lane 

 Clifton, VA 20124 

 Telephone: 202-466-6937 

Facsimile: 202-466-6938 

DATED: September 25, 2014 
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-00 AMPAC Advertisement JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-01 AMPAC Living Green JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-02 SENTRY Green Advertisement JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-03 Buckeye/Beauty.com Advertisement JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-04 Covidien e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-06 Document with OWS JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-08 Covidien e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-10 Letter from SNR Denton JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-11 Muthu Article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-12 Live Report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-13 Geneva Watch Group e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-15 Island Plastic Bags Flier JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-17 Plastic bag JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-18 Lancelot Compendium of References JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-19 TJ's biodegradable bag JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-20 GOMMUS E-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-21 7/20 Environ internal e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-22 Umbra advertisement JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-23 ECM letter to Poly-America JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-24 Umbra e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-25 Umbra Catalog JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-26 Eaton Flier JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-27 Enviroware label JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-28 Sansei bag JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-31 Eaton e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-32 Flexible Plastics Inc.: Logo JX-1-A, dated Sept. 4, 2014; Tr. 521

Respondent's RX Exhibit Index

RX-09 Command Packaging promotional materials JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

1
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-33 FP International website screen capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-34 FP International press release JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-35 e-mail to Aladina JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-36 e-mail to American Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-37 e-mail to Americo Mfg JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-38 e-mail to Bodyglovemobile JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-39 e-mail to Brooks Sports JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-40 e-mail to Clark Container JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-41 e-mail to Contempo Card JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-42 e-mail to Dole and Bailey JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-43 e-mail to Down to Earth JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-44 e-mail to Eaton JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-45 e-mail to Eco Golf JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-46 e-mail to Ecorite Imaging JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-47 e-mail to Epsilon Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-48 e-mail to E-Z Products JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-49 e-mail to Gilman Bros JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-50 e-mail to Global Garden Friends JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-51 e-mail to Global Resource International JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-52 e-mail to Gommus JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-53 e-mail to Green Packaging JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-54 e-mail to Howard Packaging JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-55 e-mail to Hunter Amenities JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-56 e-mail to Island Plastic Bags JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-57 e-mail to Italcom JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-58 e-mail to JL Clark JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-59 e-mail to Kleertech JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-60 e-mail to Ladycare Amenities JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-61 e-mail to Marietta Corp JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-62 e-mail to McNeil Engineering Corp. JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

2
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-63 e-mail to minigrip JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-64 e-mail to Odorno JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-65 e-mail One2Products JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-66 e-mail to Opiline JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-67 e-mail to PAC Worldwide JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-68 e-mail to PrimexPlastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-69 e-mail to Regal Lager JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-70 e-mail to Selan Bioscience JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-71 e-mail to Shell Packaging Corp JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-72 e-mail to Shields Bag JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-72 e-mail to Sigma Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-73 e-mail to SL Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-74 e-mail to Sondor JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-75 e-mail to Sunway Kordis JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-76 e-mail to TekPak Solutions JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-77 e-mail to Victory Plastic JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-78 1/22 3M e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-79 2/4 3M e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-80 6/4 3M e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-81 8/12 3M e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-82 8/16 3M e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-83 10/5 3M e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-84 10/28 3M e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-85 5/5 BER and customer e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-86 9/16 Dispozo e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-87 10/21 Dispozo e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-88 11/2 Dispozo e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-89 1/9 D&W Fine Pack e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-90 1/11 D&W Fine Pack e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-91 2/6 D&W Fine Pack e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

3
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-92 11/3 e-mail to D & W Fine Pack JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-93 11/16 e-mail to D & W Fine Pack JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-94 Dispozo Brochure JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-95 7/1 Eagle e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-96 6/27 Eagle e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-97 10/8 Eagle e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-98 4/23 Flexible Plastics e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-99 2/10 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-100 2/12 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-101 4/4 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-102 9/18 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-103 8/10 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-104 11/3 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-105 11/8 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-106 11/22 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-107 4/22 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-108 8/2 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-109 12/13 FP e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-110 4/10 FP e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-111 FP's The Science of Biodegradable Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-112 1/27 Island Plastic Bags e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-113 9/28 Island Plastic Bags e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-114 7/20 Island Plastic Bags e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-115 1/5 Island Plastic Bags e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-116 7/4 Island Plastic Bags e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-117 10/8 Island Plastic Bags e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-118 1/22 Island Plastic Bags e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-119 1/21 Island Plastic Bags e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-120 Barber letter to Kappus JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-121 3/22 Kappus e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

4
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-122 9/12 Kappus e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-123 10/22 Kappus e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-124 11/23 e-mail from Sigma Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-125 11/4 e-mail chain from Green Genius JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-136 3/28 Geneva Watch Group e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-138 ECM Marketing Materials JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-140 12/28 e-mail chain with Pueri Elemental JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-141 Guide for RONA Suppliers JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-142 7/21 e-mail to Earth Cure JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-134

RX-135 Collection of e-mails wherein ECM qualifies or 

refuses to provide rate of JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-139 JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-137 2/20 e-mail to Green Tech Partner Solutions JX-1-A, dated Sept. 4, 2014; Tr. 521

10/27 e-mail chain with S. Patrick Morgan

Yes

Collection of e-mails from ECM customers asking 

about shelf life of ECM products JX-1-A, dated Sept. 4, 2014; Tr. 521

Collection of e-mails from ECM customers asking 

if ECM products are biodegradable

Collection of e-mails from ECM customers asking 

questions on manufacturing process or other 

practical questions

Yes

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

Collection of e-mails from ECM customers 

inquiring on environmental friendliness of ECM 

products

JX-1-A, dated Sept. 4, 2014; Tr. 521

Collection of e-mails from ECM customers 

inquiring on whether ECM Master is FDA 

approved and/or safe for food products

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

Collection of e-mails from ECM customers 

inquiring about ECM's Masterbatch's ingredients JX-1-A, dated Sept. 4, 2014; Tr. 521

Collection of e-mails from ECM customers 

inquiring about whether ECM plastics biodegrade 

in water

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-126

RX-127

RX-128

RX-129

RX-130

RX-131 E-mail from Island Plastic Bag; customers want to 

know if foam products are biodegradable

RX-132

RX-133

Collection of e-mails from ECM customers asking 

ECM multiple questions not about rate of 

biodegradation

ECM Rule 3.46 Index

5
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-143 9/13 e-mail chain with Transilwrap JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-144 7/5 e-mail chain with Nu-Methods JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-145 1/2 e-mail chain with Begg & Co. JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-146 10/3 e-mail chain with Westchem JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-147 12/8 e-mail from BPI to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-148 12/15 e-mail from BPI to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-150 Proposal to BPI JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-151 10/23 e-mail from Mojo to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-153 9/6 e-mail from Michel to Wilshire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-154 3/5 PPC e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-155 8/20 PPC e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-156 11/24 PPC e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-157 9/13 PPC e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-158 3/30 PPC e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-159 6/1 Pregis e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-160 Dispozo Enviroware Advertisement JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 20

RX-161 Lagasse Sweet Advertisement JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-162 Ohio's Country Journal Article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-163 Licking County Article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-164 1/29 e-mail from Mojo to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-169 Who is the BPI JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-170 11/10 e-mail from Buzz to Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-171 BPI Comments on Marketing Guides JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-149 11/20 e-mail chain between Mojo and Michel

RX-165 11/13 e-mail chain between Mojo and Michel

RX-166 12/10 e-mail chain between Mojo and 

RX-167 6/25 e-mail chain between Michel and Malaree JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-168 4/18 e-mail chain between Mojo and Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

6
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-172 BPI comments on Green Guides JX-1-A, dated Sept. 4, 2014; Tr. 521

EX-173 Excerpt from Green Guides JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-174 2/27 BPI letter to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-178 BPI presentation JX-1-A, dated Sept. 4, 2014; Tr. 521

Collection of e-mails between Mojo and

RX-179 Davis

RX-180 FTC Green Packaging Claims JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-181 2/7 letter from Mojo to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-182 7/10 letter from Mojo to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-183 3/30 letter from Mojo to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-185 10/14 e-mail from Narayan to Mantri JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-187 10/21 e-mail from Mojo to Stromberg JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-188 8/29 e-mail from Narayan to Fine JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-190 BPI FAQ JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-191 7/17 Mojo e-mail to Cal Gov't JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-192 9/21 letter from Mojo to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-193 9/12 letter from Mojo to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-194 FTC goals and proposed agenda items JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-204 Aguirre Article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-177 Collection of e-mails between Mojo and Koss

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-175 Collection of e-mails between Mojo and Frankle JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-176 Collection of e-mails between Mojo and 

McCormick

RX-184 Collection of e-mails between Narayan and Mojo

RX-186 4/30 e-mail from Narayan to Russo and Sheets JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-189 7/28 e-mail chain between Mojo and Vernon JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-195 FTC: The Green Guides Statement of Basis and 

Purpose

ECM Rule 3.46 Index

7
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-207 Collection of McCarthy's patents JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-209 Umass-Lowell Press Release JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-211 6/26 e-mail from Igoe to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-213 11/15 e-mail from Wilshire to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-215 2/2 Letter from Shah to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-216 2/26 e-mail from Shah to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-220 Grant application JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-221 7/27 Shah and Michel e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-222 10/21 e-mail from Gomez to Shah JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-223 Gomez PHD Proposal JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2943

RX-225 10/10 Gomez and Michel e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-228 6/9 Gomez and Shah e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

8/6 e-mail chain between Gomez and Shah

Biodegradability and Life Cycle Analysis of Plastic 

and Bioresin Nursery Pots RX-218

2/23 e-mail chain between Shah, Michel, and 

Thomas RX-217

RX-226 2/26 e-mail chain between Michel and Shah JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-229 6/14 e-mail chain between Gomez and Shah

RX-230

RX-231

RX-227 5/19 e-mail chain between Gomez and Shah

JX-1-A dated Sept 4 2014; Tr 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

7/28 e-mail chain between Gomez and Shah

RX-214 11/18 e-mail chain between Shah and Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-224 7/7 e-mail chain between Gomez and Shah JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-219 8/18 e-mail chain between Shah and Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

8
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-236 2/1 Gomez e-mail to Shah JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-241 6/29 e-mail from Gomez to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-242 4/25 e-mail from Shah to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-243 Presentation by Michel and Gomez JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-245 Gomez Dissertation Draft JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-246 Draft report for Myers JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-247 Draft article by Gomez and Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-248 Eden 9/25 test to FP JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1475, 1491‐92, 1500, 1503‐

04, 1507, 1538, 1543‐45

RX-249 120 day test analysis JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-250 ATSDR Chapter 2: Landfill Gas Basics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-251 Eden Manual JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1455, 1464, 1471

RX-231 8/6 e-mail chain between Gomez and Shah

RX-232 8/16 e-mail chain between Gomez and Michel

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-234 1/8 e-mail chain between Gomez and Shah

RX-233

JX-1-A, dated Sept. 4, 2014; Tr. 521

10/27 e-mail chain between Gomez and Shah JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-235

RX-244 1/31 e-mail chain between Gomez and Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-240

RX-239

RX-238

5/27 e-mail chain between Gomez and Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

12/28 e-mail chain between Gomez and Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

1/31 e-mail chain between Gomez and shah JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

Tr. 2946

5/9 e-mail chain between Gomez and Shah JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-237 4/1 e-mail chain between Gomez and Shah JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

9
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-252 Eden Inoculum manual JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1456, 1461

RX-253 Article by Yagi et al produced by Eden JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-254 Environ report for BIOPVC JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1911, 2049

RX-255 Letter from Environ to Kappus 3/11 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-256 Bodycote Test cert JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-257 Bodycote Test cert JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-258 Memo for Warner to Advent Environ JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-259 Letter from Environ to Kappus 8/12 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-261 OWS protocol for study PFR-4 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-262 OWS Protocol for study PFR-3/1 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-267 OWS Final Report Infrared Analysis JX-1-A, dated Sept. 4, 2014; Tr. 521

ChemRisk Ecological Assessment of JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-269 ECM Plastic

RX-270 UNM 12/12 test JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-271 UNM 3/6 test JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-272 SSCCP Italcom test JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-272A SSCCP Italcom test translated JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-273 Ecologia Report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-274 Biofoam Degradation Test JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-275 Environ Letter to FP 3/2 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2030, 2045, 2113‐16, 2152

RX-276 Ecologia Test to 180 days JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-277 Intertek Isoe Printpack JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-278 SEM Examination of ECM Plastic JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-279 12/3 Letter from ECM to 3M JX-1-A, dated Sept. 4, 2014; Tr. 521

BPI's Background Biodegradable

RX-280 Additives to 3M

RX-265 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-264

Tr. 2015, 2071

OWS final Report; Composting test, followed by 

ecotoxicity tests

OWS Final Report; High solids Anaerobic 

Digestion (HSAD) Test

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2014

ECM Rule 3.46 Index

10
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-281 3M internal notes and e-mails JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-282 1/27 e-mail from Joseph to Baker JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-283 BER Plastic's faxes JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-284 The Truth About Biodegradable Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-285 Dispoz-o Press Release JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-286 Enviroware Premier Contract PP-DI-427 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-287 Enviroware Stages of Degradation JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-288 dispoz-o products enviroware JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-290 Enviroware FAQ JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-291 enviroware leading the Drive to "Green" JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-293 Enviroware slideshow JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-294 NACUFS newsletter JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-295 5/23 e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-297 4/26 e-mail from Leiti to Ellsworth JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-298 2/23 D&W internal e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-300 8/19 e-mail from Leiti to Hartman JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-301 5/10 e-mail from Glymph to Beecroft JX-1-A, dated Sept. 4, 2014; Tr. 521

7/11 e-mail chain between Schultz, Leiti, JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-302 and Staton

RX-303 3/20 internal D&W e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-304 Enviroware facts JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-305 Reprint of a letter to an Interested Party JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-296 10/13 e-mail chain between Swiger and green 

issues

RX-299 8/4 e-mail chain between Leiti and Swiger

RX-292 Enviroware answering FAQ and other JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-289 Questions you may concerning enviroware

ECM Rule 3.46 Index

11
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-306 5/19 Letter to Councilman Molina JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-307 1/19 Letter to Yoshimoto JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-309 4/23 e-mails from Collins to Mathias JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-310 4/23 e-mail from Collins to Mathias JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-311 6/23 e-mail chain from Eagle JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-312 4/16 e-mail chain from Eagle JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-315 Flexible Plastic Advertisement JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-317 3/14 e-mail from Hong to Flynn JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-318 3/20 e-mail from Hong to Sumira JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-320 3/5 e-mail from Hong to bby JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-324 Masternet 9/5 e-mail chain between NE Labs and 

Sweettape

RX-325 6/23 e-mail from NE Labs to ECM

RX-326 ECM Pricing Sheets JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-327 ECM Material Safety Data Sheet JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-330 ECM 6.0701 pricing sheet JX-1-A, dated Sept. 4, 2014; Tr. 521 Yes

RX-331 ECM 6.0404 pricing sheet JX-1-A, dated Sept. 4, 2014; Tr. 521 Yes

RX-332 ECM web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-308 5/25 e-mail chain between Sinclair and Santana

10/18 e-mail from Hong to Ohana Sales and 

Marketing RX-316

RX-314 1/23 Letter from Flexible Plastic to Customer

RX-323

RX-322

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-321 9/29 e-mail chain between Blood and Ghosh email chain between NE Labs and JX-1-A, dated Sept. 4, 2014; Tr. 521

Dansko e-mail chain between NE Labs and JX-1-A, dated Sept. 4, 2014; Tr. 521

NE Labs and Masternet Email chain JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

12
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-333 About ECM web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-334 Green Impact web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-335 ECM Comparison web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-336 Barber Biography JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-337 Barber C.V. JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2142-43

RX-338 9/3 e-mail from Nealis JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-342 Schwarzenegger veto JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-343 Interoffice Memorandum JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-344 9/29 e-mail from Tim to Nealis JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-345 Levis and Barlaz article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-346 Barlaz declaration JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-347 Green Guides Green Guide's statement of basis 

and JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-349 Article by Gattin et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-350 Environ letter to Albert JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-351 12/20 e-mail from Barber to Langen JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-352 ETC Report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-353 Article by Shen and Bartha JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-354 Article by Albertsson et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-355 Article by Albertsson et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-356 Designation: D5511-12 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-357 Designation: D5511-12 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-358 Designation: D5526-12 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-359 Designation: D5526-12 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-360 Article by Tokiwa et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-340

RX-341 9/23 e-mail chain between Sinclair and Tyrone JX-1-A, dated Sept. 4, 2014; Tr. 521

Standard Mutual Confidentiality Agreement JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-348 Green Guide's statement of basis and purpose JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

13
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-361 Article by Iwamoto & Tokiwa JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-362 199 Patent JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-363 Article by Fontaine et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-364 Sahu white paper JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-365 Article by Tilstra and Johnsonbaugh JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-366 10/16 Hall and Barber e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-369 7/19 e-mail chain Alire and Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-371 Report by Sinclair JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-372 11/20 Environ internal e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-373 11/17 Environ internal e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-374 7/23 Barber and Kappus e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-375 3/1 e-mails from Kappus and Pennington JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-376 6/5 e-mails from Kappus and Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-377 3/1 Kappus e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-378 Environ terms and conditions JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-379 US Greenhouse Gas Emissions JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-382 FP Web Capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-383 FP Web Capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-384 Plastics & Packaging News JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-387 Eden response to Subpoena JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-388 Clemson Test Results Phase I JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-389 Clemson Test Protocol JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-390 Clemson Test Conclusion JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-391 Clemson Test Results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-380

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-367 JX-1-A, dated Sept. 4, 2014; Tr. 521

Chapter IX to Monitored Natural Attenuation

RX-386 4/21 e-mail chain between Young and Barber

Standard test method for determining mass loss 

from plastics exposed to activated aerobic and 

anaerobic compost and landfill environments

ECM Rule 3.46 Index

14
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-392 NE Labs Report # 1048036 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-394 NE Labs Report # 1150851 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-395 NE Labs Report # 1150851 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-396 NE Labs Report # 1048819 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-397 NE Labs Report #N0946510-02 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-398 NE Labs Report #N0946510-01 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-399 NE Labs Report #N0843980 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-400 Eden Labs ASTMD5511-12 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-401 Eden Test to Smithers Oasis JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-402 Eden test to FP JX-1-A, dated Sept. 4, 2014; Tr. 521 1537

RX-403 Eden test to Fellows JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-404 Eden test to Shields JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1534-35

RX-405 NE Labs Report # 1048742-01 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-406 10/21 letter and test results from Environ JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-407 6/2 Letter and test from Environ to Kizer JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-408 OWS test for Shields JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-410 Environ Dispozo test data JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-412 OWS report for Funsam JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-413 11/3 Letter from Environ to FP JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-414 P.C. Richardson advertisement JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-416 Article by Ruiz JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-417 FP Super 8 Loosefill JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-418 FP Cell-O Air cushions JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-419 FP Speed Feeder JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-420 FP Pillow Pack JX-1-A, dated Sept. 4, 2014; Tr. 521

RX‐421 Biodegradable Plastic Packaging JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-422 Material by Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-423 Earth Aware Promotional Materials JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-424 Anderson Die & Mfg Article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-426 12/17 e-mail from Barber to Sulano JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2056

ECM Rule 3.46 Index

15
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-429 10/16 Barber and Shahar e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-430 12/8 Barber and Walters e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2064

RX-431 7/20 e-mail from Alire to Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-432 2000 article by ECM JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-434 Barber Affidavit JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-435 10/17 Environ internal e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-436 2/17 Barber e-mail to Porter JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-437 Dansko and Ecologic Gas Production JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-438 Dansko and Ecologic Gas Totals JX-1-A, dated Sept. 4, 2014; Tr. 521

Minigrip, Ecologic, Lather, Polimernet

RX-439 Gas Totals

RX-440 Minigrip Continued Gas Totals JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-441 Minigrip Data JX-1-A, dated Sept. 4, 2014; Tr. 521

Minigrip, Ecologic, Lather, Polimernet

RX-442 Gas Production

RX-443 PP Chart JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-444 PPC Gas Totals JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-445 PPC Gas Totals Continued 545 + Days JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-446 PPC Sheets JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-447 PPC-Ecologic-Transil Gas Production JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-448 PPC-ECO-TRAN Gas Totals JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-449 ppc-transil-eco 108 day totals JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-450 Tycoplas and Sweettape Gas Production JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-451 Tycoplas Gas totals JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-452 Narayan's Summary JX-1-A, dated Sept. 4, 2014; Tr. 521

3/14 e-mail chain between Katherine

RX-427 10/3 e-mail chain between Barber and Ranyi

RX-428 9/25 e-mail chain between Barber and Ranyi

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A dated Sept 4 2014; Tr 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

Tr. 2061

ECM Rule 3.46 Index

16
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-453 Johnson and Dana Rosenfeld

RX-454 EPA Facts and Figures for 2008 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-455 Initial prehearing Conference excerpt JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-456 Green Guides Excerpt JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-457 Statement of Basis and Purpose excerpt JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-460 Methane Generation in Landfills JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-462 Environ Dispozo Test Results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-463 Environ Dispozo Test Results II JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-465 SSCCP Test Report 75/2 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-466 SSCCP Test Report 9 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-469 SSCCP Test Report 10 JX-1-A, dated Sept. 4, 2014; Tr. 521

Translation certificate from Day

RX-470 Translations

RX-471 Orders by customer JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-472 Summary of Testing Data JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2251‐52, 2264, 2331, 2334‐

35, 2342

RX-473 e-mail from Barlaz to Poth on 5/13 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-474 e-mail chain between Barlaz and Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-475 e-mail chain between Barlaz and Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-475A attachment to Barlaz 8-17 e-mail to Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-476 e-mail chain between Barlaz and Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-477 e-mail chain between Barlaz and Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-478 Letter from Barlaz to Poth JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-479 BMP FP International data JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-480 Letter from Barlaz to Khalil JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-481 FP International Data Summary JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-482 Letter from Barlaz to Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-483 Letter from Barlaz to Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-484 e-mail chain between Barlaz and Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-485 Letter from Barlaz to Pech JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-486 Baldwin et al JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

17
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-487 Bareither et al JX-1-A, dated Sept. 4, 2014; Tr. 521

Performance of N. Am. Bioreactors

RX-488 Landfills II

RX-489

RX-492 Levis and Barlaz JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-493 Deipser and Stegmann JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-494 De La Cruz and Barlaz JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-495 Vermont Waste Composition Study JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-496 Eleazer et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-497 Finlay and Fenchel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-498 Hanson et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-499 Hilger and Barlaz JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-500 Solid Waste Disposal JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-501 Kjeldsen et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-502 LandGEM Version 3.02 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-503 Levis and Barlaz JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-504 Levis and Barlaz JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-505 Levis and Barlaz JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-506 Mormile et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-507 Pohland and Gould JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-508 Ress et al JX-1-A, dated Sept. 4, 2014; Tr. 521

Wake County Waste Characterization

RX-509 Study

RX-510 Shelton and Tiedje JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-511 EPA Facts and Figures for 2011 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-491

RX-490

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

Bacterial Population Development and Chemical 

Characteristics of Refuse Decomposition in a 

Simulated Sanitary Landfill

JX-1-A, dated Sept. 4, 2014; Tr. 521

Methane production from municipal refuse: A 

review of enhancement techniques and microbial 

dynamics

Forest products decomposition in municipal solid 

waste landfills

ECM Rule 3.46 Index

18
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

Inventory of US Greenhouse Gas

RX-512 Emissions and Sinks 1990-2010

Inventory of US Greenhouse Gas

RX-513 Emissions and Sinks 1990-2011

RX-514 Wang et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-515 Wang et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-516 Wang et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-517 Yesiller et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-518 Ecology of Methane Formation JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-519 Physiological Ecology of Methanogens

ECM article entitled Biodegradable

RX-520 Plastic products

RX-521

RX-522

RX-523 Environ BioPVC Final Summary JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-524 Letter from Barber to Kappus JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-525 Letter from Barber to Kappus JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-526 Letter from Barber to Kappus JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-527 Half life calculations JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-529 e-mail from Scott Hall JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-530 e-mail from Scott Hall JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-531 e-mail from Kappus to Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-532 e-mail from Hall to Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-533 e-mail from Hall to Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-534 e-mail between Kappus and Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-535 e-mail between Barber and Kappus JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-536

ECM technology for the biodegradation of plastic 

products

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Kuykindall, Barber, and Hall

JX-1-A, dated Sept. 4, 2014; Tr. 521

Life expectancy of Products manufactured with 

ECM JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

19
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-537 Barber and Kappus e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2069

RX-538 Barber and Kappus e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-539 Letter from Barber to Kizer JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-540 e-mail chain between Kizer and Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-541 e-mail chain between Barber and Hall JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-542 e-mail chain between Barber and Hall JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-543 Ramirez, Barber, and Grove e-mails JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Barber and

RX-544 Ramirez

RX-545 e-mail chain between Lichtle and Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Hall, Sutton, and

RX-546 Moore

RX-547 Image of Aerobic Condition JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-548 Image of Anaerobic Condition JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-549 Standard Test Method document JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-550 e-mail from Scott Hall JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-551 OWS Final Report PFR-3 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-552 PC Analysis JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-553 Heterephobic Plate Count Summary JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-554 e-mail chain between Barber and Hall JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-555 Barber e-mails JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-556 Dolco test data JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-558 Letter from Barber to Alire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-559 NAD Finding on Masternet JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-561 e-mail chain between Barber and Zhu JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2060, 2080

RX-562 e-mail chain between Barber and Green JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-563 e-mail from Harty to Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-565 e-mail chain between Curren and Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-566 e-mail chain between Curren and Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-564 e-mail chain between Clayton and Barber

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

20
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-567 e-mail chain between Barber and Zhu JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-568 e-mail chain between Barber and Albert JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-569 e-mail chain between Barber and Zhu JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2060

e-mail chain between Barber and

RX-571 McGregor

RX-572 e-mail chain between Sulano and Barber JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-574 e-mail chain between Barber and Albert JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-575 Additives in Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-576 Demir et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-577 EM 200 1 10 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-578 EPA G8 Final JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-579 Ling et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-580 Pramila and Ramesh JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-581 Shah et al JX-1-A, dated Sept. 4, 2014; Tr. 521

Intro to Polymer Additives and

RX-583 Stabilization

RX-584 Chap. 11 by van der Zee JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-586 Arutchelvi et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-587 Bhardwaj et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-588 EPA web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-589 Plastipedia web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-590 Tilstra and Johnsonbaugh JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Johnson and

RX-591 Rosenfeld

e-mail chain between Johnson and

RX-592 Rosenfeld

RX-570 e-mail chain between Barber and McGregor

RX-573 e-mail chain between Barber and Langen

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

Tr. 2066

ECM Rule 3.46 Index

21
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-593 e-mail from Johnson to Rosenfeld JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-594 Letter from Narayan to Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-595 E-mail from Narayan to Monica JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-596 APCO Study JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-597 APCO questions JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2511

RX-598 APCO data JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-599 APCO survey JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-600 Survey responses JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-601 Appendix A to Stewart Report JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2494

RX-602 Appendix B to Stewart report JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2568‐69, 2573, 2576

RX-603 Appendix C1 to Stewart Report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-604 Appendix C2 to Stewart Report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-605 Appendix D to Stewart Report JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2571‐72

RX-606 Appendix E to Stewart Report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-607 Appendix F1 to Stewart Report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-608 Appendix F2 to Stewart Report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-609 Data for survey JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-610 Codes JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-611 Manufacturers Survey JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-612 Verbatim answers JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-613 Environment Questionnaire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-614 Environment Tabs JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-615 Read et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-616 Frederick and Mochon JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-617 Mochon and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1030

RX-618 Automated Choice Heuristics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-619 Lee et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-620 Frederick and Shafir JX-1-A, dated Sept. 4, 2014; Tr. 521

Cognitive Reflection and Decision

RX-621 Making

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

22
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-622 Frederick and Loewenstein JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-623 Read et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-624 Read et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-625 Frederick et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-626 Simmons et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-627 Kahneman and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-628 Frederick et al JX-1-A, dated Sept. 4, 2014; Tr. 521

Valuing future life and future lives: A

RX-629 framework for understanding discounting

RX-630 Persuasive Power of Opportunity Costs

RX-631 Hedonic Adaptation JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-632 Hedonic Treadmill JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-633 Frederick et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-634 Mochon and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-635 Frederick et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-636 Fischoff et al JX-1-A, dated Sept. 4, 2014; Tr. 521

Measuring Intergenerational Time

RX-637 Preference

RX-638 Kahneman and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-639 Frederick et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-640 Soman et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-641 Kahneman and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-642 Frederick and Read JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-643 Frederick et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-644 Loewenstein and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-645 Songer et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-646 Weaver and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-647 Frederick et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-648 Frederick and Fischoff JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

23
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-649 Kahneman and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-650 Time Preference & Personal Identity JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-651 Redden and Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-652 Frederick and Peterman JX-1-A, dated Sept. 4, 2014; Tr. 521

Overestimating Others' Willingness to

RX-653 Pay

RX-654 Of Frogs and men JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-655 ACC survey JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-657 Lead Customer Contacts JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-658 Ecologic Sustainability Study Data JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-659 Ecologic Sustainability Study Data JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-670 Ecologic Sustainability Study Data JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-671

RX-671A attachment 1 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-671B attachment 2 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-673 Synovate study JX-1-A, dated Sept. 4, 2014; Tr. 521

E-mails and documents considered by

RX-674 Stewart

RX-675 Reduced customer list JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-676 Reprint of a Letter to an Interested Party JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-678 ECM Marketing Materials JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-679 ECM Sample Claims JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-680 ECM web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-681 ECM web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-682 ECM web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-683 ECM Technical Sheet JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-684 Coding JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-685 Coding JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-686 Gelman article JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

Saeed, Meyer and Frederick e-mail chain JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

24
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-687 Morgan Article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-688 Busby Article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-690 Kahan article JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-691 Kahan article II JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-692 Partial manufacturing data JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-693 Wilshire to Michel e-mail JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-694 Pessalano and Merenda e-mails JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-695 e-mail from Michel to Wilshire JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-696 e-mail from Wilshire to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-697 e-mail from Thompson to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-698 e-mail from Michel to FTCPayment JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-699 e-mail from Wilshire to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-701 e-mail from Pessalano to Michel JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-706 OSU Compost Research group JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-708 Article by Knebusch JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-709 Umass Lowell Faculty and Staff JX-1-A, dated Sept. 4, 2014; Tr. 521

Center for biodegradable Polymer

RX-710 Research

RX-711 Center for Sustainable Research JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-712 Center for Sustainable Research JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-713 Center for Green Chemistry excerpt JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-714 OWS biogas plants JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Wilshire and Michel

RX-700 e-mail from Michel Thompson and Wilshire

RX-705 e-mail chain between Wilshire and Michel

RX-704 e-mail chain between Wilshire and Michel

RX-703

RX-702

e-mail chain between Michel and Wilshire

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2991

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

25
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-715 OWS Household Waste JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-716 US Patent 5883199 A JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-717 Certain Docs considered by Volokh JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-718 e-mail from Mojo to Davis JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-719 e-mail from Mojo to Davis JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-720 e-mail from Mojo to Koss JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-721 e-mail from Mojo to Frankle JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-722 e-mail chain between Frankle to Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-723 e-mail chain between Koss and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-724 e-mail chain between Frankle and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-725 e-mail chain between Frankle and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-726 e-mail chain between Frankle and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-727 e-mail chain between Frankle and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-728 e-mail chain between Frankle and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-729 e-mail chain between Frankle and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-730 e-mail chain between Frankle and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-731 Letter from FTC to Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-732 e-mail chain between Koss and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-733 e-mail chain between Frankle and Mojo JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-734 Article by Aguirre JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-735 Submission # 00334 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-736 Song et al JX-1-A, dated Sept. 4, 2014; Tr. 521

E-mail chain between De Wilde and

RX-737 Mojo

RX-738 OWS Comments JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-740 Aliphatic-aromatic copolyester JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Johnson and

Narayan

e-mail chain between Johnson and

Brookover

RX-741

RX-742

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

26
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-743 e-mail from Narayan to Johnson JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-744 Letter from Mojo to Frankle JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-745 e-mail from Mojo to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-746 e-mail from Mojo to Koss JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-747 e-mails from Johnson JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-748 FTC Green guides for BioPlastics JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Johnson and

RX-749 Narayan

RX-750 Compilation of McCarthy Patents JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-751 Luckachan and Pillai JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-753 McCarthy declaration JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-754 Response to Action JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-756 Patent Number 5,883,199 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1892

RX-757 Metabolix steps up for UML JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-758 EASTER BIO news release JX-1-A, dated Sept. 4, 2014; Tr. 521

Center for biodegradable Polymer

Research 05

RX-760 BPI and Metabolix web capture JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-761 Metabolix affiliations JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-762 Solutia becomes Eastman JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-763 Warner Lambert and BPI JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-764 Zheng et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-765 Iwamoto and Tokiwa JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-766 Roy et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-767 Shin et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-768 Linos et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-769 Russell et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-770 Vandevivere et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-771 McCarthy et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-752

RX-759

JX-1-A, dated Sept. 4, 2014; Tr. 521

Considerations affecting biodegradability of PVC JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

27
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-772 Tutorial on Biodegradable Plastics JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-773 Gu et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-774 Gross and Gu JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-775 McCarthy et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-776 Farrell et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-777 Sheth et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-778 Gu et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-779 McCarthy et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-780 Kemnitzer et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-781 Wang et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-782 Koroskenyi and McCarthy JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-783 Shaked et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-784 Bhalakia et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-785 Parandoosh et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-786 Li and McCarthy JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-787 Biodegradable Polymers JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-788 Koroskenyi and McCarthy JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-789 Dave et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-790 Gross et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-791 Smith et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-792 Rios et al JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Meyer and

RX-793 Frederick

RX-794 Pew Research report JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-795 e-mail from APCO to FTC JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Meyer and

RX-796 Frederick

RX-797 5/12/14 survey results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-798 2/14/14 survey results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-799 3/23/14 survey results JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

28
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-800 5/12/14 survey results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-801 3/23/14 survey results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-802 5/15/14 survey results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-803 Ecologic Comments JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Meyer and

Frederick

e-mail chain between Meyer and

Frederick

RX-806 e-mail from Saeed to Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521

e-mail chain between Meyer and

Frederick

e-mail chain between Meyer and

Frederick

e-mail chain between Meyer and

Frederick

RX-811 e-mail from FTC to APCO JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-812 5/12/14 survey results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-813 Google Consumer Surveys overview JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-814 e-mail from Klein to Frederick JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1287

e-mail chain between Meyer and

Frederick

e-mail chain between Meyer and

Frederick

RX-817 5/15/2014 survey results JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-818 Chapman and Johnson JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-819 Tversky and Kahneman JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-820 Jacowitz and Kahneman JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-821 Englich et al JX-1-A, dated Sept. 4, 2014; Tr. 521

Compilation of e-mails between Frederick, Meyer, 

and Saeed

RX-804

RX-810

RX-815

RX-816

RX-805

RX-809

RX-807

RX-808

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

29
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

Compilation of articles Critiquing Google

Surveys

RX-824 Tolaymat notes JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-825 Tolaymat notes JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-826 Tolaymat notes JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-827 ISO 14855-1 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-828 Tolaymat et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-829 Tolaymat et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-831 Barlaz et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-832 Musson et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-833 EPA Presentation JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-834 Tolaymat et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-835 Final Report for 3M test JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-836 NE Labs Report # N1048340 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1587‐88, 1591

RX-837 Colplast test JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-838 NE Labs Report # 1149980 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1571

RX-839 Eden report to Shields JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1534-35

RX-840 Deposition transcript of Ryan Burnette JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-0841 Deposition Transcript of Dr. McCarthy JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-0842 Deposition Transcript of Dr. Sahu JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-0843 Deposition Transcript of Dr. Stewart JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-0844 Survey Data JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2748, 2757, 2800

RX-0844A Subset of Survey Data RX-844 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2748

RX-0846 Table of Contents JX-1-A, dated Sept. 4, 2014; Tr. 521

Tr. 1086, 1088, 2718, 2724, 

2771-72, 2779, 2795, 2801, 

2810-11 

RX-823

RX-822 How the Questions Shape the Answers

Tr. 1412, 2694, 2737, 2758,

2775, 2795 RX-0847 Environment Study Screenshot CSRS #32240

Tr. 2698, 2703, 2719, 2724 Progress Report CSRS #32240 Environmental 

Study to D. Stewart from Y. Linares RX-0845

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

ECM Rule 3.46 Index

30
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-0849 Data from Manufacturers' Survey JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-0851 Deposition Transcript of Dr. Tolaymat JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 242

RX-0853 Expert Report of Dr. Morton Barlaz JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2170, 2175, 2194, 2196, 

2294, 2299

RX-0854 Expert Report of Dr. Ryan Burnette JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2370

RX-0855 Expert Report of Dr. Ranajit (Ron) Sahu JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1737

RX-0856 Expert Report of Dr. David Stewart JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1080, 2493, 2548, 2555, 

2571, 2649-50, 2684, 2686

RX-0857 Expert Report of Dr. Alexander Volokh JX-1-A, dated Sept. 4, 2014; Tr. 521-

---Withdrawn from evidence Tr. 2475

RX-859 Eden Report to FP JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-860 Eden Report to FP JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-861 Eden Report to MicroTek JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-862 Eden Report to EcoLab JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-863 NE Labs Report to Dansko JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-866 Article by Brown and Marlar JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-867 US Census Bureau page JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-868 Article by Hamilton JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-869 Report by Keeter, et al JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-878

4 mos after launch, pitiful Google Consumer Surveys 

struggles to find its footing JX-1-A, dated Sept. 4, 2014; Tr. 521

Exhibit 4 to Frederick Deposition - Table of Survey

Characteristics

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-0852

Progress Report CSRS #32241 Environmental 

Study to D. Stewart from Y. Linares RX-0850 Tr. 2815

RX-879

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

Google fixes 5 problems

RX-0858

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-865

RX-877 Feature or Bug? Google Consumer Surveys pre-fills in 

the Answer for You

RX-0848 Manufacturers' Survey Screenshot CSRS #32241

Deposition Transcript of Dr. Shane Frederick

E-mail chain between Katherine Johnson and 

Mark Leen

Tr. 1105‐06

Tr. 1189

ECM Rule 3.46 Index

31
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-880

Cure for Color Blindness Being Explored on Google 

Consumer Surveys JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-881

Google Consumer Surveys Begins to Hit Stride 

Locating Low-Incidence Populations JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-882

BBB Latest Group to Throw Away Money on Google 

Consumer Surveys JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-883

If we Deliver the Garnet Hill Catalog to you in 

Microfiche, would you think less of us then? JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-885

Throw away all of these questions and start over... JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-889

If at first you don’t succeed with google consumer 

surveys, fail fail again JX-1-A, dated Sept. 4, 2014; Tr. 521

Tr. 1109

RX-891

Jobs? Did someone say job? JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-893

All things being equal... JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-899

Tolaymat Depo 4A JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 337

RX-900

Tolaymat Depo 4B JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 337

RX-901

Tolaymat Depo 4C JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 337

RX-902

Tolaymat Depo Exhibit 5 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-904

Tolaymat Depo Exhbit 7 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 304

RX-905

Tolaymat Depo Exhibit 8 JX-1-A, dated Sept. 4, 2014; Tr. 521

Tr. 267

RX 906

Tolaymat Depo Exhibit 9 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 240

RX-908

Tolaymat Depo Exhibit 11 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 291, 293

RX-909

Tolaymat Depo Exhibit 12 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 291

RX-911

Tolaymat Depo Exhibit 14 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 311

What part of Yes don’t you understand?

RX-884

RX-886

RX-887

RX-888

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1370-01, 1373, 1376

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-890

RX-892

RX-894

RX-895

Google Consumer Surveys allows DIY Researchers to 

confuse check one and check all that apply

Intuit Labs using Google Consumer

How many GCS are being taken by Google

Obsession with Junk Clicks Continues to

Google Consumer Surveys Hidden Revenue Stream

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

The essence of DIY Google Consumer Surveys

Harris Poll using Interns to analyze Google Consumer 

Surveys

ECM Rule 3.46 Index

32
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-918

Tolaymat Depo Exhibit 21 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 325

RX-919

Tolaymat Depo Exhibit 22 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 324-25

RX-920

Tolaymat Depo Exhibit 23 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 327

RX-921

Tolaymat Depo Exhibit 24 JX-1-A, dated Sept. 4, 2014; Tr. 

521* Tr. 330

RX-923

McCarthy Depo Exhibit 1 JX-1-A, dated Sept. 4, 2014; Tr. 521

Tr. 636, 1772

RX-924

McCarthy Depo Exhibit 2 JX-1-A, dated Sept. 4, 2014; Tr. 521

Tr. 488, 494, 514, 570-71, 

RX-925

McCarthy Depo Exhibit 3 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 511, 527, 643, 646, 667, 

1873, 1875

RX-926

McCarthy Depo Exhibit 4 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-927 McCarthy Depo Exhibit 5 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-928 McCarthy Depo Exhibit 6 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 535, 598, 649

RX-929 McCarthy Depo Exhibit 7 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-930 McCarthy Depo Exhibit 8 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-931 McCarthy Depo Exhibit 9 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-932 McCarthy Depo Exhibit 10 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-933 McCarthy Depo Exhibit 11 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-934 McCarthy Depo Exhibit 12 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-935 McCarthy Depo Exhibit 13 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-936 McCarthy Depo Exhibit 14 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-937 McCarthy Depo Exhibit 15 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-938 McCarthy Depo Exhibit 16 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-939 McCarthy Depo Exhibit 17 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-940 McCarthy Depo Exhibit 18 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 578, 581

RX-941 McCarthy Depo Exhibit 19 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 583

RX-942 McCarthy Depo Exhibit 20 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 585

RX-943 McCarthy Depo Exhibit 21 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-944 McCarthy Depo Exhibit 22 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-945 McCarthy Depo Exhibit 23 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 586

RX-946 McCarthy Depo Exhibit 24 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 587

RX-947 McCarthy Depo Exhibit 25 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-948 McCarthy Depo Exhibit 26 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 589

ECM Rule 3.46 Index

33
RX Description Where Admitted Tr. Pages Where 

Discussed In Camera

RX-949 Frederick Depo Exhibit 1 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1192, 1269

RX-950 Frederick Depo Exhibit 2 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1255

RX-951 Frederick Depo Exhibit 3 JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 1300‐02

RX-952 Frederick Depo Exhibit 4 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-953 Frederick Depo Exhibit 5 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-954 Frederick Depo Exhibit 6 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-955 Frederick Depo Exhibit 7 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-956 Frederick Depo Exhibit 8 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-957 Frederick Depo Exhibit 9 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-958 Frederick Depo Exhibit 10 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-959 Frederick Depo Exhibit 11 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-960 Frederick Depo Exhibit 12 JX-1-A, dated Sept. 4, 2014; Tr. 521

RX-962 Metabolix 2008 – License Agreement JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 599

RX-963 Metabolix 2012 - Letter JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 602

RX-964 Metabolix 2014 - Letter JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 606

RX-965 Umass-Metabolix License execution JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 599, 609

RX-966 Metabolix e-mails JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 607

RX-967 EPA web page JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 341

RX-969 The Influence of Injection Molding Conditions on 

Biodegradable Polymers Tr. 644-45 Tr. 643‐45

RX-970 Michel Deposition Transcript JX-1-A, dated Sept. 4, 2014; Tr. 521 Tr. 2821

RX-968

RX-961 Metabolix 2006 – Fee for Service Agreement Tr. 595

The attached excel sheet (can call ECM 

Anaerobic Degradability Analysis Summary Data) JX-1-A, dated Sept. 4, 2014; Tr. 521

JX-1-A, dated Sept. 4, 2014; Tr. 521

*Referenced at hearing as RX document, but on JX-1-A as CCX document

ECM Rule 3.46 Index

34
UNITED STATES OF AMERICA 

BEFORE THE FEDERAL TRADE COMMISSION 

OFFICE OF THE ADMINISTRATIVE LAW JUDGES 

Washington, D.C. 

In the Matter of 

ECM BioFilms, Inc., 

a corporation, also d/b/a 

Enviroplastics International, 

Respondent. 

 

Docket No. 9358 

PUBLIC 

 

RESPONDENT ECM BIOFILMS’ POST-TRIAL BRIEF 

Jonathan W. Emord, Esq. 

Emord & Associates, P.C. 

11808 Wolf Run Lane 

Clifton, VA 20124 

Ph: 202-466-6937 

Fx: 202-466-6938 

Em: jemord@emord.com 

Peter A. Arhangelsky, Esq. 

Eric J. Awerbuch, Esq. 

Bethany R. Kennedy, Esq. 

Joshua Furman 

Emord & Associates, P.C. 

3210 S. Gilbert Road, Ste 4 

Chandler, AZ 85286 

Ph: 202-466-6937 

Fx: 602-393-4361 

Em: parhangelsky@emord.com, eawerbuch@emord.com, 

 bkennedy@emord.com 
    PUBLIC DOCUMENT 

ii 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

TABLE OF CONTENTS 

I. SUMMARY OF THE CASE ............................................................................................. 1 

II. PRESENTATION OF EVIDENCE ................................................................................. 14 

A. Respondent’s Experts ................................................................................................... 15 

1. Dr. Ranajit Sahu ....................................................................................................... 17 

2. Dr. Morton Barlaz..................................................................................................... 19 

3. Dr. Ryan Burnette ..................................................................................................... 20 

4. Dr. David Stewart ..................................................................................................... 22 

B. Respondent’s Fact Witnesses ....................................................................................... 24 

1. Robert Sinclair (ECM).............................................................................................. 24 

2. Kenneth Sullivan (ECM) .......................................................................................... 27 

3. Thomas Poth (Eden Laboratories) ............................................................................ 28 

4. Alan Johnson (Northeast Laboratories) .................................................................... 28 

5. Dr. Timothy Barber (Environ Corp.) ........................................................................ 29 

C. Complaint Counsel’s Experts ....................................................................................... 30 

1. Thabet Tolaymat ....................................................................................................... 30 

2. Steven McCarthy ...................................................................................................... 31 

3. Shane Frederick ........................................................................................................ 31 

4. Frederick Michel (Rebuttal) ..................................................................................... 32 

D. Complaint Counsel’s Fact Witnesses ........................................................................... 33 

III. ARGUMENT ................................................................................................................... 35

A. Complaint Counsel Has the Burden of Production on Charges in the 

Complaint ..................................................................................................................... 36 
    PUBLIC DOCUMENT 

iii 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

B. Complaint Counsel Has The Burden of Proof to Show that ECM Made 

Claims, That those Claims Were False or Misleading, and that the 

Claims Were Material .................................................................................................. 37 

C. Complaint Counsel Has Failed to Meet Their Burden to Prove that ECM 

Conveyed Implied Biodegradability “Rate” Claims .................................................... 39 

1. Extrinsic Evidence of High Methodological Quality Reveals that 

ECM Did Not Make Implied Claims Concerning the Rate or Extent of 

Biodegradation.......................................................................................................... 43 

a. Dr. Stewart’s Telephone Survey Was Well-Designed, 

Incorporated Open-Ended Clear Questions, And Incorporated 

Established Principles Of Survey Research. ..................................................... 44 

b. Dr. Stewart’s Survey Confirms that Not Even a Significant 

Minority of End-Use Consumers or ECM Customers Have a 

Single Definition of Biodegradation or Expectation as to the Rate 

at Which ECM Plastics Will Biodegrade .......................................................... 47 

c. Complaint Counsel’s Survey Expert Relies on Incompetent 

Google Survey to “Correct” Incompetent Synovate and APCO 

Surveys .............................................................................................................. 49 

2. ECM Permanently Discontinued the ........................................................................ 54 

3. Complaint Counsel’s Straw Man Definition of “Biodegradable” Is 

Unsupported by Science, and Arbitrary and Capricious .......................................... 59 

a. The Scientific Definition of Biodegradation Conflicts with 

Complaint Counsel’s Definition ........................................................................ 61 

b. The Anti-Competitive Effect of Enforcement of Complaint 

Counsel’s Biodegradation Definition ................................................................ 66 

c. The So-Called “One Year” Rule Was Based on Deliberately 

Skewed Market Data that Is Not Reflective of Actual Consumer 

Impression ......................................................................................................... 73 

D. Complaint Counsel Failed to Meet Their Burden of Showing that 

ECM’s Unqualified Biodegradation Claim Is False or Misleading in 

Any Material Respect ................................................................................................... 77 
    PUBLIC DOCUMENT 

iv 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

4. ECM Additive Efficacy Depends on Strict Adherence to ECM 

Manufacturing Instructions ....................................................................................... 82 

5. The Type of Scientific Evidence That Experts Agree is Competent 

and Reliable to Prove Biodegradability .................................................................... 86 

6. The Absence of Any Standards or Tests to Prove Rates of 

Biodegradation in Landfills ...................................................................................... 87 

7. Competent and Reliable Biodegradation Testing Methods Relevant to 

This Case .................................................................................................................. 92

a. Gas Evolution Reactor Tests (e.g., ASTM D5511) ........................................... 94 

b. BMP Testing ...................................................................................................... 98 

c. Qualitative Testing .......................................................................................... 100 

d. Radiolabeling Tests Are Not Required ............................................................ 102 

E. ECM Possesses a Reasonable Basis, and at Least Competent and 

Reliable Scientific Evidence, that the ECM Additive Causes Plastics to 

Biodegrade in Landfills .............................................................................................. 107 

1. The Products Involved Do Not Affect Consumer Health or Safety, or 

the Performance of the Products While Used by Consumers ................................. 108 

2. The Type Of Claims Made Are General Efficacy Claims that Are 

Subjective ............................................................................................................... 110 

3. The Benefits of a Truthful Claim and Ease of Developing 

Substantiation for the Claims ................................................................................. 110 

4. The Consequences of a False Claim Are Negligible and Complaint 

Counsel Has Provided No Record Evidence Suggesting that Any 

Consumer Could Have Been Harmed Through a False Claim ............................... 114 

5. The Competent and Reliable Scientific Evidence Proves that ECM’s 

Additive Renders Conventional Thermoplastics “Biodegradable” ........................ 116 

a. Testing of the ECM Additive Confirms that It Accelerates the 

Biodegradation Process ................................................................................... 121 

b. Complaint Counsel’s Criticisms of ECM’s Testing Are 

Theoretical and Lack Empirical Support ......................................................... 127 
    PUBLIC DOCUMENT 

v 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

i. ECM’s testing conditions adequately simulate or replicate 

landfill settings ......................................................................................... 127 

ii. Microbes Are Capable of Biodegrading Conventional 

Plastics ...................................................................................................... 129 

iii. Complaint Counsel’s Theory that Biodegradation Does Not 

Occur in Landfills Is Scientifically Erroneous ......................................... 131 

iv. The Positive Laboratory Tests Do not Have Fatal 

Methodological Flaws .............................................................................. 135 

v. The Limited Number of Inconclusive Tests Do Not Rise to 

the Level of Evidence that ECM’s Product Is Inefficacious .................... 138 

vi. The Priming Effect Is an Unproven Myth ................................................ 140 

6. Complaint Counsel’s Scientific Experts Tolaymet, McCarthy, and 

Michel Are Not Credible ........................................................................................ 144 

a. Dr. Thabet Tolaymat’s “Expert” Opinion Is Not Credible or 

Reliable ............................................................................................................ 144 

b. Dr. Steven McCarthy’s “Expert” Opinion Is Not Credible or 

Reliable ............................................................................................................ 149 

i. Dr. McCarthy’s Shifting Positions ........................................................... 149 

ii. Dr. McCarthy’s Hypocritically Demands that ECM Rely on 

Experimental Testing Methods and Standards that Dr. 

McCarthy Neither Uses Nor Requires for His Own Claims of 

Biodegradability in Plastics ...................................................................... 152 

iii. Dr. McCarthy’s Failure to Consider Scientific Data ................................ 157 

iv. Dr. McCarthy’s Adoption of a Litigation Definition for 

“Biodegradable” that Is Not Supported by Science ................................. 158 

v. Dr. McCarthy Is a Biased Witness with Financial Interests in 

the Outcome of This Litigation, and His Testimony 

Reflected That Bias .................................................................................. 161 

F. Complaint Counsel Has Failed to Prove that Claims Concerning 

Biodegradation Rate Are Material to Purchasing Decisions ...................................... 167 
    PUBLIC DOCUMENT 

vi 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

1. To Determine Whether A Claim Is False Or Misleading, The Trier of 

Fact Must View the Claim from the Perspective of the Target 

Audience ................................................................................................................. 176 

2. ECM’s Target Audience and Actual Customers Were Sophisticated 

Purchasers That Studied the Product and Engaged in Sophisticated 

Transactions ............................................................................................................ 177 

3. The Bases for Purchase Among Sophisticated Customers Differ from 

Those of End Use Consumers ................................................................................ 182 

4. Complaint Counsel Has Failed to Prove that Any Consumer Was 

Misled ..................................................................................................................... 184 

5. The Sophisticated Purchaser Defense Is Applicable in This Case ......................... 187 

G. Complaint Counsel’s Censorship of “Biodegradable” Claims Violates 

the First Amendment .................................................................................................. 188 

H. Complaint Counsel’s Enforcement Action Against ECM Is Not in the 

Public Interest ............................................................................................................. 195 

I. The FTC’s Suggested Remedy Is Unlawful and Unsupported by the 

Facts ........................................................................................................................... 201 

1. The FTC’s Proposed Order Requires Proof of a “Rate” for 

Biodegradation When There Is No Competent and Reliable Evidence 

to Prove Any Set Rate ............................................................................................ 201 

2. Complaint Counsel Has Failed Prove to That the “Extent” of 

Biodegradation Is Relevant to a Consumer Claim ................................................. 203 

3. Complaint Counsel’s Proposed Order Is Vague and Ambiguous, and 

It Would Impose Unworkable Standards................................................................ 203 

J. Complaint Counsel’s Case Against ECM Constitutes Ultra Vires 

Agency Action and Is an Assumption of Regulatory Power Not Vested 

in FTC, but in the EPA ............................................................................................... 205 

K. The “One-Year” Rule Is An Unlawful Industry-Wide Trade Regulation 

Rule ............................................................................................................................ 209 

L. Complaint Counsel’s Case Against ECM Violates Due Process ............................... 211 
    PUBLIC DOCUMENT 

vii 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

1. The FTC Proceedings Violate the Separation of Functions Doctrine .................... 211 

2. Complaint Counsel’s Abusive Discovery Practices ............................................... 213 

3. Unfair Surprise ....................................................................................................... 217 

IV. CONCLUSION .............................................................................................................. 220 

 
    PUBLIC DOCUMENT 

viii 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

TABLE OF AUTHORITIES 

Cases

Acxiom Corp. v. Axiom, Inc., 27 F. Supp. 2d 478 (D. Del. 1998) .......................................... 185 

Akin v. Ashland Chem. Co., 156 F.3d 1030 (10th Cir. 1998) ................................................ 187 

Alliance for Natural Health U.S. v. Sebelius, 714 F.Supp. 2d 48 (D.D.C. 2010) .................. 193 

Am. Civil Liberties Union v. Mukasey, 534 F.3d 181 (3d Cir. 2008) .................................... 190 

Ancient Coin Collectors Guild v. U.S. Customs & Border Prot., Dep't of 

Homeland Sec., 698 F.3d 171 (4th Cir. 2012) ........................................................... 205, 209 

Archer Daniels Midland Co. v. Aon Risk Services, Inc. of Minnesota, 187 F.R.D. 

578 (D.Minn. 1999) ............................................................................................................ 214 

Ariz. Cartridge Remanufacturers Assoc., Inc. v. Lexmark Int’l, Inc., 290 F. Supp. 

2d 1034 (N.D. Cal. 2003) ................................................................................................... 177 

Armstrong Cork Co. v. World Carpets, Inc., 597 F.2d 496 (5th Cir. 1979) .......................... 178 

Arnold Stone Co. v. FTC, 49 F.2d 1017 (5th Cir. 1931) ................................................ 195, 198 

Baker v. Monsanto Co., 962 F. Supp. 1143 (S.D. Ind. 1997) ................................................ 187 

Banque Franco–Hellenique de Commerce Int’l., et Maritime, S.A. v. 

Christophides, 106 F.3d 22 (2d Cir. 1997) ......................................................................... 183 

Bd. of Trustees of State Univ. of New York v. Fox, 492 U.S. 469 (1989) .............................. 189 

Beneficial Corp. v. FTC, 542 F.2d 611 (3d Cir. 1976) .......................................................... 189 

Berger v. United States, 295 U.S. 78 (1935) .......................................................................... 214 

Bolger v. Youngs Drug Products Corp., 463 U.S. 60 (1983) ................................................ 189 

Bowman v. Gen. Motros Co., 427 F.Supp. 234 (E.D. Pa. 1977) ............................................ 219 

Bristol-Myers Co. v. Fed. Trade Comm'n, 738 F.2d 554 (2d Cir.1984) .................................. 86 

Byrd v. Hunt Tool Shipyards, 650 F.2d 44 (5th Cir. 1981) .................................................... 187 

Castrol, Inc. v. Pennzoil Co., 987 F.2d 939 (3d Cir. 1993) ................................................... 176 

Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 

447 U.S. 557 (1980) ........................................................................................... 189, 191, 193 

Chambers v. Mississippi, 410 U.S. 284 (1973) ...................................................................... 214 

Checkpoint Sys., Inc. v. Check Point Software Tech., 269 F.3d 270 (3d Cir.2001) ............... 177 

Cheney Bros., Inc. v Batesville Casket Co., Inc., 47 F.3d 111 (4th Cir. 1995) ...................... 183 

Chicago Bride & Iron Co. N.V. v. F.T.C., 534 F.3d 410 (D.C. Cir. 2008) .......................... 1, 36 
    PUBLIC DOCUMENT 

ix 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

Citizens United v. Fed. Election Comm'n, 558 U.S. 310 (2010) ........................................... 190 

City of Cincinnati v. Discovery Network, Inc., 507 U.S. 410 (1993) ..................................... 192 

Cliffdale Assocs., Inc., 103 F.T.C. 110 (1984) ...................................................................... 167 

Coastal Abstract Serv., Inc. v. First Am. Title Ins. Co., 173 F.3d 725 (9th Cir. 

1999) ..................................................................................................................................... 41 

Cooper v. Salazar, 196 F.3d 809 (7th Cir. 1999) ....................................................................... 1 

Cota v. Tucson Police Dep’t, 783 F. Supp. 458 (D. Ariz. 1992) ............................................. 81 

Country Tweeds, Inc. v. F.T.C., 326 F.2d 144 (2d Cir. 1964) ............................................... 168 

D.C. Federation of Civic Ass'ns v. Volpe, 459 F.2d 1231 (D.C. Cir. 1971) .......................... 211 

Davidson v. Wilson, 973 F.2d 1391 (8th Cir. 1992) .............................................................. 184 

Davis v. Avondale Indus., 975 F.2d 169 (5th Cir. 1992) ....................................................... 187 

DeSena v. Beekley Corp., 729 F. Supp. 2d 375 (D. Me. 2010) ............................................. 176 

Dickinson v. Zurko, 527 U.S. 150 (1999) ................................................................................ 60 

Direct Mktg. Concepts, Inc. v. F.T.C., 581 F. Supp. 2d 115 (D. Mass. 2008) ....................... 108 

Edenfield v. Fane, 507 U.S. 761 (1993) ................................................................................. 194 

Emergent Capital Inv. Mgmt., LLC v. Stonepath Grp., Inc., 343 F.3d 189 (2d Cir. 

2003) ................................................................................................................................... 182 

Epstein v. MCA , Inc., 54 F.3d 1422 (9th Cir. 1995) ............................................................. 214 

F.T.C. v. Bronson Partners, LLC, 564 F. Supp. 2d 119 (D. Conn. 2008) ................... 37, 39, 42 

F.T.C. v. Colgate-Palmolive Co., 380 U.S. 374 (1965) ......................................................... 167 

F.T.C. v. Garvey, 383 F.3d 891 (9th Cir. 2004) ....................................................................... 37 

F.T.C. v. Medlab, Inc., 615 F. Supp. 2d 1068 (N.D. Cal. 2009) ............................................ 107 

F.T.C. v. NHS Syss., Inc., 936 F. Supp. 2d 520 (E.D. Pa. 2013) ............................................ 167 

F.T.C. v. Raladam Co., 316 U.S. 149 (1942) ................................................................. 167, 195 

F.T.C. v. Simeon Management Corp., 532 F.2d 708 (1976) .................................................. 189 

F.T.C. v. Wash Data Ress., 856 F. Supp. 2d 1247 (M.D. Fla. 2010) ..................................... 168 

First Health Group Corp. v. BCE Emergis Corp., 269 F.3d 800 (7th Cir. 2001) ............. 41, 54 

First Health Grp. Corp. v. BCE Emergis Corp., 269 F.3d 800 (7th Cir. 2001) ................ 41, 54 

FTC v. Braswell, 2005 WL 4227194 (C.D. Cal. Sept. 27, 2005) .......................................... 107 

FTC v. Direct Marketing Concepts, 569 F.Supp. 2d 285 (D.Mass. 2008) .............................. 35 
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ECM’s Post-Trial Brief 

FTC v. Pantron I Corp., 33 F.3d 1088 (9th Cir. 1994) ........................................ 35, 77, 87, 107 

FTC v. QT, Inc., 448 F.Supp. 2d 908 (N.D. Ill. 2006) ....................................................... 77, 78 

FTC v. Royal Milling Co., 288 U.S. 212 (1933) .................................................................... 195 

FTC v. Tashman, 318 F.3d 1273 (11th Cir. 2003) ................................................................... 37 

Gilchrist Timber Co. v. ITT Rayonier, Inc., 95 F.3d 1033 (11th Cir. 1996) .......................... 183 

Giorgio Beverly Hills, Inc. v. Revlon Consumer Prods. Corp., 869 F. Supp. 176 

(S.D.N.Y. 1994) ................................................................................................................. 185 

Goodbar v. Whitehead Bros., 591 F. Supp. 552 (W.D. Va. 1984 ) ....................................... 187 

Gustafson v. Alloyd Co., 513 U.S. 561 (1995) ....................................................................... 186 

Hirsch v. du Pont, 553 F.2d 750 (2d Cir. 1977) .................................................................... 183 

Homeowners Grp., Inc. v. Home Mktg. Specialists, Inc., 931 F.2d 1100 (6th Cir. 

1991) ................................................................................................................................... 185 

Hunter v. F.E.R.C., 569 F. Supp. 12 (D.D.C. 2008) .............................................................. 206 

In re Adventist Health Sys./West, 117 F.T.C. 224 (Apr. 1, 1994) ............................................ 37 

In Re Kraft, Inc., 114 F.T.C. 40 (1991) .................................................................................... 39 

In re Murchison, 349 U.S. 133 (1955) ................................................................................... 211 

In re Novartis Corp., 127 F.T.C. 580 (1999) ......................................................................... 169 

In re Pfizer Inc., 81 F.T.C. 23 (1972) ................................................................................ 72, 78 

In re Stouffer Foods Corp., 118 F.T.C. 746 (Sept. 26, 1994) .................................................. 42 

In re Synthroid Mktg. Litig., 264 F.3d 712 (7th Cir. 2001) .................................................... 185 

In re Trans Union Corp. Privacy Litig., 2009 WL 4799954 (N.D. Ill. Dec. 9, 

2009) ................................................................................................................................... 186 

In the Matter of Charles F. Harad, 50 F.T.C. 300 (1953) ............................................. 196, 197 

In the Matter of Pom Wonderful LLC, 9344, 2012 WL 2340406 (F.T.C. May 17, 

2012) .............................................................................................................................. passim 

In the Matter of Pom Wonderful LLC, Roll Global LLC, Stewart A. Resnick, Lynda 

Rae Resnick & Matthew Tupper, 155 F.T.C. 1 (2013) ......................................................... 86 

In the Matter of R.J. Reynolds Co., Inc., FTC Dkt. No. 9206, 1988 WL 490114 

(Mar. 4 1988) ........................................................................................................................ 54 

In the Matter of Removatron Int’l Corp., 111 F.T.C. 206 (Nov. 4, 1988) ............. 108, 110, 114 

In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648 (1984) ........................... 39, 40, 108 
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ECM’s Post-Trial Brief 

Int’l Ladies' Garment Workers' Union v. Donovan, 722 F.2d 795 (D.C. Cir. 1983) ............... 59 

Interstellar Starship Servs., Ltd. v. Epix Inc., 184 F.3d 1107 (9th Cir. 1999) ....................... 185 

Irwin v. F.T.C., 143 F.2d 316 (8th Cir. 1944) ........................................................................ 196 

John Crane Prod. Solutions, Inc. v. R2R and D, LLC, 861 F. Supp. 2d 792 (N.D. 

Tex. 2012) .................................................................................................................... 49, 177 

Kiser v. Reitz, 13-3956, 2014 WL 4211193 (6th Cir. Aug. 27, 2014) ................................... 191 

Kline v. First Western Gov’t Sec., Inc., 24 F.3d 480 (3d Cir. 1994) ...................................... 183 

Koch v. FTC, 206 F.2d 311 (6th Cir. 1953) ................................................................... 198, 220 

Kraft, Inc. v. FTC, 970 F.2d 311 (7th Cir. 1992) .............................................................. passim 

Larson v. Domestic & Foreign Commerce Corp., 337 U.S. 682 (1949) ....................... 205, 209 

Leer Elec., Inc. v. Penn. Dep’t of Labor and Indus., 597 F. Supp. 2d 470 (M.D. Pa. 

2009) ................................................................................................................................... 213 

lliance for Natural Health U.S. v. Sebelius, 786 F. Supp. 2d 1 (D.D.C. 2011) ............. 192, 193 

Marketquest Group Inc. v. BIC Corporation, et al., No. 11-cv-618, 2011 

WL5360899 (S.D. Cal. Nov. 7, 2011) ................................................................................ 186 

Marketquest Grp., Inc. v. BIC Corp., 2011 WL 5360899 (S.D. Cal. Nov. 7, 2011) ............. 184 

Matter of Cliffdale, 103 F.T.C. 110 (1984) .................................................................... 167, 168 

Mead Data Dent., Inc. v. Toyota Motor Sales, U.S.A., Inc., 875 F.2d 1026 (2d Cir. 

1989) ................................................................................................................................... 184 

Metavante Corp. v. Emigrant Sav. Bank, 619 F.3d 748 (7th Cir. 2010) ................................ 183 

Miller v. Berman, 289 F. Supp. 2d 1327 (M.D. Fla. 2003) .................................................... 186 

Motor Vehicle Manufacturers Association v. State Farm Mutual Automobile 

Insurance Co., 463 U.S. 29 (1983) ....................................................................................... 59 

Murray Space Shoe Corp. v. F.T.C., 304 F.2d 270 (2d Cir. 1956) ........................................ 168 

Nationwide Book Indus., LLC v. A & S Booksellers, Inc., 950 F. Supp. 2d 264 (D. 

Mass. 2013) ........................................................................................................................ 186 

Nemir v. Mitsubishi Motors Corp., 200 F.Supp.2d 770 (E.D. MI 2002) ................................. 81 

O’Neal v. Celanese Corp., 10 F.3d 249 (4th Cir. 1993) ................................................ 187, 188 

Oreck v. U.S. Floor Sys., Inc., 803 F.2d 166 (5th Cir. 1986) ................................................. 177 

Pearson v. Shalala, 130 F.Supp. 2d 105 (D.D.C. 2001) ........................................................ 194 

Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) .......................................................... passim 
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Perini Corp. v. Perini Constr., 915 F.2d 121 (4th Cir.1990) ................................................. 177 

Porter & Dietsch, Inc. v. F.T.C., 605 F.2d 294 (7th Cir. 1979) ............................................... 37 

Prebble v. Brodrick, 535 F.2d 605 (10th Cir. 1976) .............................................................. 217 

Price v. Trans Union, LLC, 847 F.Supp. 2d 788 (E.D. Pa. 2012) ......................................... 214 

Pride Family Brands, Inc. v. Carl’s Patio, Inc., -- F. Supp. 2d --, 2014 WL 186902 

(S.D. Fla. Jan. 30, 2014) ..................................................................................................... 185 

Roberts v. United N. Mex. bank at Roswell, 14 F.3d 1076 (5th Cir. 1994) ........................... 183 

Rust Env't & Infrastructure, Inc. v. Teunissen, 131 F.3d 1210 (7th Cir. 1997) ..................... 177 

S. Buchsbaum & Co. v. FTC, 160 F. 2d 121 (7th Cir. 1947) ......................................... 199, 200 

Sahaviriya Steel Industries Public Co. Ltd. v. U.S., 601 F. Supp. 2d 1355 (C.I.T. 

2009) ........................................................................................................................... 206, 209 

Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990) ................... 176 

Schering-Plough Healthcare Prods., Inc. v. Schwartz Pharma, Inc., 547 F. Supp. 

2d 939 (E.D. Wisc. 2008) ................................................................................................... 176 

Schwarz Pharma, Inc. v. Breckenridge Pharm., Inc., 388 F.Supp.2d 967 (E.D. 

Wis. 2005) .......................................................................................................................... 176 

Sears, Roebuck and Co. v. F.T.C., 76 F2d 385 (9th Cir. 1982) ............................................. 189 

Seven-Up Co. v. Coca-Cola Co., 86 F.3d 1379 (5th Cir. 1996) .............................................. 41 

Skeen v. C.I.R., 864 F.2d 93 (9th Cir. 1989) .......................................................................... 184 

Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134 (9th Cir 1997) .............................. 176 

Specialty Equip. Mkt. Ass’n v. Ruckelshaus, 720 F.2d 124 (D.C. Cir. 1983) .......................... 59 

Standard Oil C. of California v. F.T.C., 577 F.2d 653 (9th Cir. 1978) ................................. 188 

Sterline Drug, Inc. v. F.T.C., 741 F.2d 1146 (9th Cir. 1984) .................................................. 37 

Terra Sec. Asa Konkursbo v. Citigroup, Inc., 740 F. Supp. 441 (S.D.N.Y. 2010) ................ 182 

Thomas v. FTC, 116 F.2d 347 (10th Cir. 1940) ..................................................................... 195 

Time Warner Cable, Inc. v. DIRECTV, Inc., 497 F.3d 144 (2d Cir. 2007) ............................. 42 

Tom Hughes Marine, Inc. v. Am. Honda Motor Co., Inc., 219 F.3d 321 (4th Cir. 

2000) ................................................................................................................................... 183 

United States v. IBM Corp., 66 F.R.D. 215 (S.D.N.Y. 1974) .................................................. 81 

Utica Packing Co. v. Block, 781 F.2d 71 (6th Cir. 1986) .............................................. 211, 212 

Western States Medical Center, 535 U.S. 357 (2002) ........................................................... 192 
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Whitaker v. Thompson, 248 F.Supp. 2d 1 (D.D.C. 2002) .............................................. 193, 194 

Withrow v. Larkin, 421 U.S. 35 (1975) .................................................................................. 211 

Wong Yang Sung v. McGrath, 339 U.S. 33 (1950) ................................................................ 212 

Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 

U.S. 626 (1985) .......................................................................................................... 189, 190 

Zurich Ins. Co. v. Amcor Sunclipse N. Am., 241 F.3d 605 (7th Cir. 2001) .............................. 41 

Statutes

15 U.S.C. § 57a .................................................................................................................. 8, 210 

42 U.S.C. § 6901 .................................................................................................................... 206 

5 U.S.C. § 553 ............................................................................................................ 8, 210, 211 

5 U.S.C. § 556 ...................................................................................................... 1, 37, 211, 212 

5 U.S.C. § 706 .......................................................................................................... 59, 206, 209 

Other Authorities

Black’s Online Law Dictionary (2d Ed.) ................................................................................. 41 

Collins English Dictionary, 10th Ed. 2009 .............................................................................. 62 

FTC Policy Statement on Deception, Federal Trade Commission (1983) ............................... 39 

Trial Practice, 35 Stetson L. Rev. 1139 (2006) ....................................................................... 35 

Rules

Fed. R. Evid. 804 ................................................................................................................... 182 

Regulations

16 C.F.R. § 260.1 ....................................................................................................................... 7 

16 C.F.R. § 260.8 .............................................................................................................. passim 

16 C.F.R. § 3.11 ..................................................................................................................... 212 

16 C.F.R. § 3.31A .................................................................................................................. 218 

16 C.F.R. § 3.43 ................................................................................................................... 1, 37 

16 CFR § 260.7 ...................................................................................................... 60, 68, 73, 74 

8

CCX 1 .................................................................................................................................... 6, 7 

CCX 234 .................................................................................................................................. 27 

CCX 266E .............................................................................................................................. 118 
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CCX 268A .............................................................................................................................. 118 

CCX 48 .................................................................................................................................. 180 

CCX 534 ................................................................................................................................ 121 

CCX 546 ................................................................................................................................ 120 

CCX 547 ................................................................................................................................ 121 

CCX 548 ................................................................................................................................ 120 

CCX 791 ................................................................................................................................ 100 

CCX 800 ................................................................................................................................ 170 

CCX 803 ................................................................................................................................ 170 

CCX 811 ........................................................................................................................... passim 

CCX 812 ................................................................................................................................ 170 

CCX 817 ................................................................................................................................ 171 

CCX 818 .................................................................................................................. 40, 102, 169 

CCX 820 ................................................................................................................................ 102 

CCX 83 .................................................................................................................................... 97 

CCX 84 .............................................................................................................................. 94, 95 

CCX 882 ................................................................................................................................ 171 

CCX 890 .................................................................................................................................. 13 

CCX 891 ........................................................................................................................... passim 

CCX 892 ........................................................................................................................ 150, 166 

CCX 893 .......................................................................................................................... 92, 144 

CCX 91 .................................................................................................................................... 68 

CCX 943 .......................................................................................................................... 68, 109 

CCX 951 ................................................................................................................................ 142 

RX 130 ..................................................................................................................................... 84 

RX 159 ................................................................................................................................... 179 

RX 171 ................................................................................................................................... 164 

RX 172 ............................................................................................................................. 67, 164 

RX 178 ............................................................................................................................. 84, 178 
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RX 195 ................................................................................................................. 49, 75, 76, 170 

RX 209 ................................................................................................................................... 162 

RX 210 ................................................................................................................................... 164 

RX 211 ............................................................................................................................. 70, 164 

RX 248 ................................................................................................................................... 119 

RX 254 ........................................................................................................................... 101, 120 

RX 259 ................................................................................................................................... 101 

RX 263 ................................................................................................................................... 121 

RX 265 ................................................................................................................................... 121 

RX 266 ................................................................................................................................... 121 

RX 268 ................................................................................................................................... 121 

RX 269 ........................................................................................................................... 101, 118 

RX 273 ................................................................................................................................... 119 

RX 274 ................................................................................................................................... 119 

RX 275 ................................................................................................................................... 119 

RX 276 ................................................................................................................................... 119 

RX 277 ................................................................................................................................... 119 

RX 278 ................................................................................................................................... 119 

RX 326 ..................................................................................................................................... 85 

RX 335 ..................................................................................................................................... 84 

RX 356 ......................................................................................................................... 95, 96, 97 

RX 362 .............................................................................................................................. passim 

RX 367 ..................................................................................................................................... 67 

RX 370 ................................................................................................................................... 101 

RX 371 ............................................................................................................................. 83, 117 

RX 388 ................................................................................................................................... 119 

RX 392 ................................................................................................................................... 120 

RX 393 ................................................................................................................................... 120 

RX 394 ................................................................................................................................... 120 
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RX 395 ................................................................................................................................... 120 

RX 396 ................................................................................................................................... 120 

RX 398 ................................................................................................................................... 120 

RX 399 ................................................................................................................................... 120 

RX 401 ................................................................................................................................... 120 

RX 402 ................................................................................................................................... 120 

RX 403 ................................................................................................................................... 119 

RX 405 ................................................................................................................................... 120 

RX 412 ..................................................................................................................................... 85 

RX 413 ..................................................................................................................................... 85 

RX 458 ..................................................................................................................................... 84 

RX 465 ................................................................................................................................... 118 

RX 467 ................................................................................................................................... 119 

RX 468 ................................................................................................................................... 119 

RX 472 ................................................................................................................................... 122 

RX 511 ..................................................................................................................................... 73 

RX 520 ..................................................................................................................................... 85 

RX 522 ..................................................................................................................................... 84 

RX 56 ....................................................................................................................................... 51 

RX 573 ................................................................................................................................... 100 

RX 585 ..................................................................................................................................... 51 

RX 593 ................................................................................................................................... 161 

RX 601 ............................................................................................................................... 22, 23 

RX 656 ..................................................................................................................................... 83 

RX 673 ..................................................................................................................................... 75 

RX 678 ..................................................................................................................................... 84 

RX 680 ............................................................................................................................. 13, 117 

RX 681 ......................................................................................................................... 36, 56, 83 

RX 718 ..................................................................................................................................... 70 
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RX 725 ..................................................................................................................................... 84 

RX 741 ..................................................................................................................................... 70 

RX 744 ................................................................................................................................... 164 

RX 748 ..................................................................................................................................... 84 

RX 755 ............................................................................................................................. 65, 130 

RX 756 ........................................................................................................................... 128, 166 

RX 757 ............................................................................................................................. 81, 162 

RX 772 ..................................................................................................................................... 68 

RX 836 ........................................................................................................................... 112, 121 

RX 838 .............................................................................................................................. passim 

RX 839 ................................................................................................................................... 119 

RX 841 .............................................................................................................................. passim 

RX 842 ........................................................................................................................... 104, 130 

RX 851 .............................................................................................................................. passim 

RX 853 .............................................................................................................................. passim 

RX 854 ............................................................................................................. 99, 129, 131, 150 

RX 856 .............................................................................................................................. passim 

RX 858 ......................................................................................................................... 49, 51, 53 

RX 863 ........................................................................................................................... 121, 126 

RX 864 .............................................................................................................................. passim 

RX 865 ................................................................................................................................... 117 

RX 87 ....................................................................................................................................... 57 

RX 870 ............................................................................................................... 96, 99, 101, 130 

RX 871 ............................................................................................................................. 58, 180 

RX 875 .............................................................................................................................. passim 

RX 928 ........................................................................................................... 105, 151, 153, 154 

RX 940 ........................................................................................................................... 105, 154 

RX 942 ................................................................................................................................... 105 

RX 945 ................................................................................................................................... 156 
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RX 948 ................................................................................................................................... 156 

RX 952 ..................................................................................................................................... 99 

RX 967 .............................................................................................................................. passim 

RX 968 .............................................................................................................................. passim 

RX-756 ................................................................................................................................... 127 

 
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In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

I. SUMMARY OF THE CASE 

As the charging party for the agency, Complaint Counsel bears the burden of production. 

Chicago Bridge & Iron Co. N.V. v. F.T.C., 534 F.3d 410, 425 (D.C. Cir. 2008) (quotation 

omitted) (“The burden of production is the obligation to come forward with evidence of a 

litigant’s necessary propositions of fact”). At a minimum, that burden requires the calling of fact 

witnesses sufficient to state a prima facie case of deceptive advertising under Section 5 of the 

FTC Act. See, e.g., Cooper v. Salazar, 196 F.3d 809, 815 (7th Cir. 1999) (holding that an 

effective opportunity for cross-examination is required by the Due Process Clause where the 

ultimate decision necessarily requires important credibility determinations). Complaint Counsel 

has failed to satisfy that fundamental burden. Despite deposing over 19 fact witnesses in the prehearing phase, Complaint Counsel called not a single one at hearing, resting their case 

exclusively on the testimony of four expert witnesses. That decision has proven fatal because the 

resulting record is devoid of foundational facts necessary for Complaint Counsel to meet the 

elements of their case. Having not pled facts sufficient to meet the elements of their case, 

Complaint Counsel must undergird their legal argument with speculation, thus failing to meet 

their burden of proof. 16 C.F.R. § 3.43(a) (“Counsel representing the Commission . . . shall have 

the burden of proof, but the proponent of any factual proposition shall be required to sustain the 

burden of proof with respect thereto.”); see also 5 U.S.C. § 556(d) (explaining that “the 

proponent of a rule or order has the burden of proof”); In re ECM Biofilms, Order on Post-Trial 

Briefs, Dkt. 9358 (Sep. 3, 2014), at 3 (The parties were instructed to “not cite to expert testimony 

to support factual propositions that should be established by fact witnesses or documents”). 

The following facts had to be adduced from testimony at the hearing to meet Complaint 

Counsel’s burden of production, but were not: (1) facts sufficient to show that at least a 
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significant minority of those who purchased the ECM additive did so in reliance on a rate claim 

(the now defunct claim that plastics infused with the additive would biodegrade within 9 months 

to 5 years or the claim that plastics so diffused would biodegrade in some period greater than a 

year); (2) facts sufficient to show that at least a significant minority of those who purchased the 

ECM additive did so with the expectation that it would cause plastics so infused to biodegrade 

completely within one year after customary disposal, meaning that it would cause 100% of the 

plastic to be broken down into elements in nature within that time period; (3) facts sufficient to 

show that at least a significant minority of those who purchased the ECM additive considered the 

rate of biodegradation material to their purchase; (4) facts sufficient to show that at least a 

significant minority of those who purchased the ECM additive considered material to their 

purchase a complete break down of the ECM additive infused plastic into elements found in 

nature; and (5) facts sufficient to show that ECM lacked a reasonable basis for the claim that the 

ECM additive causes plastics to biodegrade faster than plastics not containing the additive. On 

those five essential elements of factual proof Complaint Counsel has not a shred of credible 

evidence in the record. Accordingly, based solely on a failed burden of production, the 

Complaint should be denied because in light of that failure Complaint Counsel cannot satisfy 

their burden of proof and any cease and desist order and any fencing in provision would 

therefore be arbitrary and capricious, an abuse of agency discretion, and a violation of the free 

speech rights of the respondent on this record. 

Complaint Counsel’s case collapses in the end because Complaint Counsel never did 

prove at all, let alone by the requisite preponderance of the evidence, that ECM’s actual 

customers, or a significant minority of them, were recipients of a deceptive advertising message 

material to their purchasing decisions. Not one shred of reliable evidence exists that actual 
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customers considered any claim made by ECM material to a purchase, other than the general 

claim of biodegradability. See Respondent ECM’s Proposed Finding of Facts at ¶¶ 1–3003 

(hereinafter “RPFF”). Not even a significant minority of ECM customers has been shown to 

have made a purchasing decision on the basis of anything other than an understanding that 

plastics infused with the ECM additive are more biodegradable than plastics not so infused, 

which the scientific record reveals to be demonstrably true (i.e., to be supported by at least a 

reasonable basis). (RPFF ¶¶ 296–725). Not even a significant minority of end use consumers 

has been shown to purchase ECM infused plastics, as opposed to obtain them for free, and to be 

aware of ECM, its claims, or the fact that any of the plastics they have obtained and used are 

those of ECM. Of those who obtain plastics at retail, there is no evidence that even a significant 

minority have any common understanding of the term biodegradable or any common conception 

of a set rate for biodegradation of plastics. (RPFF ¶¶ 1105–1344). 

The record confirms that ECM spends only about $12,000 per year on advertising, the 

vast majority of which goes to pay to maintain the ECM web site. (RPFF ¶ 300). The web site 

is designed for its plastic manufacturer customers; ECM does not sell to end use consumers and 

its product is not available for purchase to them in any online venue, including, e.g., 

Amazon.com. (Sullivan, Tr. 765–66). The record confirms that ECM’s customers are not lay 

consumers but are sophisticated plastics manufacturers who themselves have downstream 

business or retail customers, often two or three levels removed from end use consumers. 

(Sullivan, Tr. 904; RPFF ¶¶ 296–432). The record confirms that these customers test the ECM 

additive and engage in a period of assessment in reliance on their own scientists, engineers, 

lawyers, and marketing people that spans a period of six months to several years before ever 

purchasing and including the ECM additive in their plastic products. (RPFF ¶ 355). The record 
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In re ECM Biofilms, Dkt. No. 9358 

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confirms that in almost every, if not in every, case those customers predicate their purchasing 

decisions not on what ECM tells them but on their own assessment of the ECM product. (RPFF 

¶¶ 355–367). Given their sophistication and the fact that they base their purchase on their own 

evaluation, including testing, this case is fundamentally one in which advertising material to a 

purchase is not in issue. Indeed, because the record reveals the purchase to be made based on a 

sophisticated independent assessment and not a paid for advertising message, the content here in 

issue does not even meet the definition of “advertising” and, even if it did, the facts do not 

support a conclusion that the “advertising” was material to a purchase (which materiality hinges 

instead on these sophisticated purchasers own, lengthy evaluations of actual samples of the 

product). (RPFF ¶¶ 296–739). 

There is scant evidence that any claim made by ECM to its actual customers ever reaches 

end use consumers when they receive a plastic product containing the ECM additive, and there is 

no evidence that end use consumers purchase the finished plastic products here in issue or, if 

they do, purchase ones that bear overt labeling that associates the products with ECM or any 

claim. (RPFF ¶¶ 296–725). Complaint Counsel came up with several rare exceptions at hearing, 

but those examples represent a very small fraction of ECM products in the market, those 

products were given away and not “sold” to any consumer, and there is no evidence of any kind 

in the record that, in those limited situations, customers considered those claims material to any 

purchasing decision. 

Most, if not all, of the ultimate retail customers of ECM’s plastic manufacturer customers 

distribute the ECM infused plastic products, such as plastic bags, to end use consumers free of 

charge. (Sinclair, Tr. 765–67). The record fails to show that even a significant minority of 

ECM’s customers who manufacture plastics or those manufacturer’s ultimate wholesale and 
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In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

retail customers include on plastics any identification of ECM and any claim whatsoever, 

including any claim of biodegradation or rate of biodegradation. (RPFF ¶¶ 296–725). 

Complaint Counsel offered no evidence of the frequency or amount of ECM rate claims and 

logos that appear in the market, except to offer several rare examples. Certainly Complaint 

Counsel offered no proof to establish that even a significant minority of end use consumers has 

any knowledge of ECM or any claim made by ECM and, indeed, the only survey evidence on 

that point, from ECM survey expert Dr. David Stewart, confirms that they lacked that familiarity. 

(RPFF ¶¶ 1105–1344). 

To be sure, based on the Stewart survey evidence, those end use consumers do not have 

any common understanding of the meaning of the term biodegradation or any common 

understanding that plastics labeled biodegradable will biodegrade within any specific time frame. 

(RPFF ¶¶ 1105–1344). 

The uncontroverted record establishes that ECM’s actual plastic manufacturer customers 

are indeed sophisticated, having their own engineers, scientists, lawyers, and marketing 

departments. (RPFF ¶¶ 356, 417–18). They take between 6 months to several years to evaluate 

the ECM additive before making a decision to purchase the ECM product. (Sullivan, Tr. 703–

04). ECM’s customers test the ECM product themselves before infusing it into the plastics they 

sell. (Sinclair, Tr. 761–63; Sullivan, Tr. 704–05). The record confirms that ECM engages in 

extensive communication with its customers, encouraging them to test the product to determine 

its biodegradability, transparently supplying them with the scientific evidence ECM possesses, 

explaining that biodegradation of any particular piece of plastic infused with the ECM additive 

will occur over time and that no set rate or time can be predicted for any given piece of ECM 

additive infused plastic (that being dependent upon where the plastic ends up in the environment 
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and the ambient temperature, moisture, and other biodegrading matter conditions at that 

location). (See e.g., RPFF ¶¶ 419–426). Nearly all of the 30+ of the positive ASTM D5511 tests 

concerning biodegradation that are in evidence, (RPFF ¶¶ 2129–2706), are not ones ECM 

ordered but are independent, critical evaluations of ECM additive infused plastics by ECM 

customers that wished to determine before purchase if the additive would cause their plastics to 

biodegrade. Note well that not a single one of those tests endeavored to determine an actual rate 

of biodegradation rather than intrinsic biodegradability, evincing vital secondary, confirmatory 

proof that ECM’s customers purchased the product based on concern for the fact of 

biodegradation, not the rate of biodegradation. (RPFF ¶¶ 2129–2706). 

 When it comes to the meaning of biodegradation, the record is likewise very clear. The 

meaning ECM conveyed to its customers in association with that term is spelled out, quite 

literally, in the certificate of biodegradability ECM issued to every one of its customers after they 

confirmed manufacture of their plastics in strict accord with ECM’s manufacturing instructions. 

(RPFF ¶ 320; CCX 1). That definition given to ECM’s customers reads as follows: 

A Degradable Plastic is defined (ASTM 1991) as a plastic that is designed to 

undergo a significant change in its chemical structure under specific 

environmental conditions resulting in a loss of some properties that may vary 

as measured by standard test methods appropriate to the plastic and the 

application in a period of time that determines its classification. A 

Biodegradable Plastic is defined as a degradable plastic in which the 

degradation results from the action of naturally occurring microorganisms 

such as bacteria, fungi and algae. 

(See, e.g., CCX 1 (ECM Certificate of Biodegradability)). 

 That definition does not mirror the one adopted by the Commission in the Green Guides 

at 16 C.F.R. § 260.8(c), which reads: “Unqualified claims for items that are customarily disposed 

in landfills, incinerators, and recycling facilities are deceptive because these locations do not 

present conditions in which complete decomposition will occur within one year.” 16 C.F.R. § 
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260.8(c); In re ECM Biofilms, Complaint, Dkt. No. 9358, at 12 ¶ 4(A)–(B). It is that Green 

Guides’ definition that Complaint Counsel insists must be adopted by the Administrative Law 

Judge in this case, despite the fact that no ECM customer was ever told by ECM that the Green 

Guides’ definition applied to the ECM product and despite the fact that competent survey 

evidence refutes the notion that either consumers or ECM’s own customers shared any common 

expectation that the term biodegradable connotes complete break down of the plastic into 

elements in nature within one year after customary disposal. 

Rather, the only definition given to each customer by ECM is the one contained in 

ECM’s Certificate of Biodegradability. (CCX 1; see also RX 35–77 (example emails sent by 

ECM to customers explaining the regulatory landscape following revisions to the Green 

Guides)). That definition, which is the present ASTM definition for the term and comports with 

the definitions contained in the scientific literature in this case (RPFF ¶¶ 767–817), sets no time 

limit on the process of biodegradation and does not require 100% break down of the plastic into 

elements found in nature.1

 

 This Court need not adopt the definition in the Green Guides if, indeed, it is understood 

not to be a Commission rule but, rather, a guidance, as the Green Guides itself proclaims: “The 

guides ... do not confer any rights on any person and do not operate to bind the FTC or the 

public.” 16 C.F.R. § 260.1(a). That is because the given definition of ECM is, itself, a 

qualification revealing no rate limit and no assurance of 100% break down. 

                                                             1 Compare RPFF ¶¶ 767–817 (citing broad definitions of “biodegradable” accepted by 

the scientific community), and Tolaymat, Tr. 130 (citing broad definition of “biodegradable”), 

and Michel, Tr. 2907–08 (broad definition of “biodegradable”), and Sahu, Tr. 1760 (broad 

definition of “biodegradable”), and Barlaz, Tr. 2281 (same), and Burnette, Tr. 2376 (same), and 

Barber, Tr. 2069 (same), with (RX 841 (McCarthy, Dep. at 20)) (McCarthy and Complaint 

Counsel’s narrow definition of “bioedegradable”). 
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 Were the Administrative Law Judge to hold, as Complaint Counsel insists, that the Green 

Guides’ definition is despite its Green Guides’ label, an actual rule of decision and to apply it in 

this case (hereinafter we refer to it as the “One Year Rule”), then the Administrative Law Judge 

must of necessity must evaluate that rule under the rulemaking requirements of Magnusson 

Moss, see 15 U.S.C. § 57a, and under the Administrative Procedure Act. See 5 U.S.C. § 553. 

Under the rulemaking requirements, the adoption of the One Year Rule by guidance and not 

through the process specified in 15 U.S.C. § 57a violates the law and, thus, the One Year Rule 

still cannot serve as a rule of decision.2 Even if it were deemed to satisfy the rulemaking 

requirements, the One Year Rule is nevertheless arbitrary and capricious as applied in this case, 

because the record reveals that it results in absurd distinctions and is grossly inconsistent with 

not one, not most, but all of the peer-reviewed scientific definitions of biodegradable plastics in 

the record. (RPFF ¶¶ 460–510). Indeed, adherence to the One Year Rule results in absurd 

conclusions that bananas, banana peels, orange peels, tree trunks, and paper are not 

biodegradable when generally accepted scientific evidence is to the contrary. (McCarthy, Tr. 

506–509). Adherence to the One Year Rule results in the draconian and irrational rule of 

decision that a plastic which biodegrades to 95% on the 365th day after customary disposal is not 

biodegradable even if biodegradation of that same plastic reaches 100% on the 366th day. 

(McCarthy, Tr. 495–96, 525–26; RX 841 (McCarthy, Dep. at 28)). Indeed, the record evidence 

reveals that virtually no substance, and certainly no plastic, can reliably break down into 

elements found in nature within one year after customary disposal, thus exposing the rule to be 

indistinguishable with an actual ban on every biodegradable plastics claim (and by dint thereof 

                                                             2

 For example, because the FTC did not properly characterize the industry rule as a Trade 

Regulation Rule under Section 57a, the Commission did not apparently notify and seek input 

from the Committee on Commerce, Science, and Transportation of the Senate and the 

Committee on Energy and Commerce of the House of Representatives. See 15 U.S.C. § 57a(2). 
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every biodegradable plastic product) for the record reveals no evidence that any plastic can 

reliably biodegrade to the extent of breaking down completely into elements found in nature 

within one year.3 The record reveals no evidence that when biodegradable plastics (or 

compostable products for that matter) break down in nature they do so to the point of causing 

every molecule of plastic to be converted into an element found in nature, rather than for some of 

the plastic to remain as a residue (a residue that is in nearly every respect indistinguishable from 

common dirt). (Michel, Tr. 2960–62). What public interest is served by the FTC banning the 

term biodegradable from products that effect biodegradation of plastics in 2 years, 3 years, 4 

years, a decade, or even 100 years, when conventional plastics not treated may remain in the 

environment for hundreds or thousands of years? (Sahu, Tr. 1758–59; CCX 891 at ¶ 17). What 

public interest is served by the FTC banning the term biodegradable from products that effect 

biodegradation of plastics to the extent of eliminating most or nearly all of them but not 100% of 

them? 

 Moreover, the agency’s own experts are hopelessly conflicted in their efforts to defend 

the One Year Rule. That effort to defend the One Year Rule against the prevailing science to the 

contrary revealed FTC’s lead scientific expert McCarthy to be a biased and unreliable witness. 

At trial McCarthy was impeached repeatedly when he testified in conflict with his deposition 

testimony that certain obviously natural and biodegradable substances are not “biodegradable.” 

(McCarthy, Tr. 503, 506, 508–09, RX 841 (McCarthy, Dep. at 187)). Following testimony 

revealing that he could not cite a single peer-reviewed scientific article in which scientists 

defined biodegradation as FTC had in the Green Guides (or as he himself did in Footnote 1 to his 

Expert Report)—that despite the false affirmative avowal in his Expert Report at footnote 1 that 

                                                             3 See, e.g., Tolaymat, Tr. 247–48 (explaining that even “rapidly degrading” waste is 

expected to take no less than ten years to biodegrade in a landfill). 
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Complaint Counsel’s One Year Rule and the scientific definition of the term biodegradable were 

“interchangeable,” (McCarthy, Tr. 486)—Dr. McCarthy asked if it was too late to change his 

definition of the penultimate term in issue “biodegradable.” (McCarthy, Tr. 496). Even in 

McCarthy’s own professional writings, he never once defined biodegradation as the FTC has in 

the Green Guides (and as Complaint Counsel did in footnote 1 to McCarthy’s Expert Report). 

(RPFF ¶¶ 1362–1369). Moreover, no other scientist at hearing or in this field defined the term as 

FTC has. (RFPP ¶¶ 460–510). 

There is no evidence that a significant minority of ECM customers ever considered 

material to a purchasing decision any claim here in issue other than the one that plastics infused 

with the ECM additive would biodegrade. (RFPP ¶¶ 798–1037). Indeed, the evidence 

overwhelmingly confirms that ECM’s actual customers did not consider rate of biodegradation 

material to their decision to purchase and did not rely on any claims of rate in making a 

purchase. (RFPP ¶¶ 1038–1328). The purchase was predicated on their view, informed most 

commonly by their own critical testing of plastics infused with the ECM additive, that the ECM 

additive causes plastics to biodegrade faster than untreated plastics. (RFPP ¶¶ 1038–1328). 

They were not concerned with the rate of biodegradation, and with good reason. Rapid 

biodegradation within one year of customary disposal (to the level of breaking down the plastic 

into elements in nature) increases greenhouse gases, adversely affecting the environment. (RFPP 

¶¶ 1592–1603). 

Consequently, Complaint Counsel is obliged to construct their case based on assumptions 

and inferences which are neither factually nor legally competent. They recite the following sets 

of claims they say ECM made to its customers: 
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 ECM Plastics are biodegradable, i.e., will completely break down and 

decompose into elements found in nature within a reasonably short period of 

time after customary disposal; 

 ECM Plastics are biodegradable in a landfill; 

 ECM Plastics are biodegradable in a stated qualified timeframe; and 

 ECM Plastics have been shown to be biodegradable, biodegradable in a 

landfill, or biodegradable in a stated qualified timeframe under various 

scientific tests including, but not limited to, ASTM D5511. 

See In re ECM Biofilms, Complaint, at 8, Dkt. 9358. 

They presume the claims were all material to a purchasing decision by those customers 

but, despite ECM survey evidence confirming no materiality, they never rebut that proof. By 

contrast, multiple forms of evidence from direct customer testimony to Dr. Stewart’s surveys of 

ECM customers and consumers prove that claims of rate of biodegradation were neither relevant 

nor material to even a significant minority of either. 

Complaint Counsel presume that a subset of inconclusive test results involving plastics 

infused with the ECM additive is the same as affirmative proof that the ECM additive does not 

cause plastics to biodegrade, but they never competently investigated the inconclusiveness in any 

of those tests, including that of their own consultant, Dr. Frederick Michel. They never 

undertook any scientific evaluations to determine the actual cause of the inconclusive results to 

rule out the commonly expected failings arising from: death of the microbes in the inoculum, 

mis-manufacture of the plastic, or the presence in the test plastic of other additives or fillers that 

may contain anti-microbial agents, to name a few. They condemn all 30+ independent tests of 

the ECM additive that show biodegradation of the plastic infused with the additive without 

scientific foundation and without any analysis of the data derived from the tests. 
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Having failed to prove that the product does not biodegrade, they nevertheless presume 

that at least a significant minority of ECM customers purchased the ECM additive on the 

assumption that it would cause the plastics to biodegrade within one year after customary 

disposal or, if not that, within 9 months to 5 years after customary disposal, and yet even their 

own depositions of ECM customers fail to support that conclusion with deponent after deponent 

denying that rate claims were either material or relevant to their purchase of the ECM additive. 

(RPFF ¶¶ 1038–1350). 

Having failed to prove that plastics infused with the ECM additive do not biodegrade and 

having failed to prove that ECM’s actual customers depend on rate claims as a basis for their 

purchase of the additive, Complaint Counsel presume that at least a significant minority of those 

to whom ECM does not sell its product, i.e., end use consumers, harbor an understanding that 

plastics containing the ECM additive biodegrade within one year after customary disposal. 

Fundamentally, however, Complaint Counsel has not presented factual evidence, let alone 

proven, that at least a significant minority of end use consumers even understand whether 

plastics they have obtained (most commonly not by purchase) are ECM plastics or are 

biodegradable. Complaint Counsel’s survey expert, Dr. Shane Frederick, asked no screening 

questions in his single question Google Consumer Surveys and, thus, did not qualify his survey 

respondents in a way that would reveal whether any of them were aware of whether any of the 

plastic products with which they have come into contact are biodegradable or contain ECM’s 

additive or bear an ECM claim. (Frederick, Tr. 1224–25; RPFF ¶ 602). 

In that regard, there is no record evidence revealing what quantity of plastics in the 

market are ones infused with the ECM additive and, of those, which ones contain any logo or 

claim by ECM. ECM itself is not aware of that information because its customers are ordinarily 
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too far removed from retail.4 There is no record evidence establishing whether a significant 

minority of consumers has ever seen an ECM claim on a plastic infused with an ECM additive or 

has ever visited the ECM web site and associated an ECM claim there with a plastic product in 

the market that they have obtained (the web site presents no such information in any event). (RX 

-82) (ECM website captures)). 

Although Dr. Shane Frederick performed Google Consumer Surveys and represents that a 

significant minority of consumers understand the term biodegradable to mean that products will 

biodegrade in one year or less, (CCX 890 (Frederick, Rep. at 1)), he is biased and his surveys are 

unreliable (as explained more fully below), failing to satisfy any of the principles required for 

competent survey research. (RPFF ¶¶ 572–798). The only competent survey research in this 

case, that of Dr. Stewart whose surveys and opinions the FTC and Administrative Law Judges 

within the FTC have repeatedly credited, reveals that consumers do not by a significant minority 

share any common definition of biodegradation or any common view of the rate at which plastics 

biodegrade. (RPFF ¶¶ 799–1038). In the end, however, the critical basic element of evidence, 

that a significant minority of consumers have even seen, let alone acquired, a plastic bearing an 

ECM logo or claim in the market is lacking. 

In the end, Complaint Counsel has failed to prove by a preponderance of the evidence 

that a significant minority of ECM customers or consumers were deceived by any claim made by 

ECM. The only claim made to ECM’s actual customers, and not proven to be associated in the 

market by even a significant minority of consumers who have obtained plastics containing the 

ECM additive, is that the ECM additive causes plastics infused with it to be more biodegradable 

than plastics without it, which claim is demonstrably true based on the testimony of three experts 

                                                             4 See, e.g., Sinclair, Tr. 703–04, 707, 759; Sullivan, Tr. 696; RPFF ¶¶ 386–392. 
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(an environmental scientist, a plastics engineer, and a biochemist) and over 30+ independent 

tests showing biodegradation. The evidence concerning product efficacy points decidedly in 

favor of the Respondent, establishing its claim of biodegradation to have more than a reasonable 

basis sufficient to support the biodegradation claim. The totality of the scientific evidence 

establishes more than a reasonable basis, and at least competent and reliable scientific evidence, 

that plastics infused with the ECM additive (in accordance with ECM manufacturing instructions 

and at a 1% load rate) will biodegrade within a reasonably short period of time under conditions 

of customary disposal, particularly when compared with conventional, untreated plastics. (RPFF 

¶¶ 1964–2009, 2129–2885). The totality of the scientific evidence, including generally accepted 

science on microbiological mechanisms that degrade plastics and on biodegradation in landfills 

as well as at least dozens of separate biodegradation tests and assessments of the ECM additive 

by the plastics industry, establish more than a reasonable basis, and at least competent and 

reliable scientific evidence, that ECM’s additive causes biodegradation of the most widely used 

plastic resins in the external environment, including in landfills. 

II. PRESENTATION OF EVIDENCE 

The hearing convened in Docket Number 9358 on August 5, 2014. (RPFF ¶ 33). The 

evidentiary hearing was completed on August 29, 2014, and the record closed on September 4, 

2014. (RPFF ¶ 36–7). Complaint Counsel chose to call no fact witnesses in support of its case. 

(RPFF ¶ 256). Although having taken 29 depositions, and having designated all of those 

witnesses in its final witness list, Complaint Counsel never called a single one to testify. (RPFF 

¶¶ 31, 256). In many instances, because of the massive cost involved with the over-burdensome 

deposition schedule, ECM was not financially able to have its counsel appear at deposition, or 

had to limit its counsel’s appearance to telephone. (RPFF ¶ 32). Although that was ECM’s 
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choice, it was borne of economic necessity and Complaint Counsel sought to exploit that fact by 

leaving fact witnesses out of the courtroom, thus preventing ECM from having an effective 

opportunity to cross examine those witnesses at hearing. Regardless, as explained in more detail 

below, those deposition transcripts must be devalued because the FTC has made no showing that 

the witnesses were unavailable to appear at hearing, the Administrative Law Judge has been 

denied an opportunity to adjudge in person their testimony (essential for credibility findings), 

and opposing counsel has been denied a full and fair opportunity to adduce additional material 

facts through cross-examination at hearing necessary to determine the relative weight of 

testimony given. Nevertheless, in the vast majority of cases, the deposition transcripts actually 

cut against Complaint Counsel and support ECM’s case in that witness after witness stated that 

his or her company had no concern for the rate of biodegradation. (RPFF ¶¶ 360, 1114–17, 

1219–22, 1226–27, 1239–42, 1248, 1250–53, 1259–63, 1279–82, 1284, 1295–1301).

A. Respondent’s Experts 

ECM called four expert witnesses to testify in its defense. (RPFF ¶¶ 151, 182, 201, 217). 

Dr. Ranaji Sahu, an environmental, mechanical, and chemical engineer, testified concerning the 

mechanisms of action involved in plastics biodegradation and the totality of the scientific 

evidence concerning biodegradation of plastics in general and biodegradation of ECM additive 

infused plastics in particular, concluding that competent and reliable scientific evidence in the 

form of 30+ biodegradation tests of plastics containing the ECM additive confirm that the 

additive causes plastics to biodegrade faster than they would without the additive. (RPFF ¶¶ 

152, 1631–32, 1722). Dr. Morton Barlaz, a civil and chemical engineer considered an authority 

on landfills and biodegradation of plastics in landfills, testified that landfills are not dry tombs 

but are biologically active and hospitable environments where biodegradation of plastics can and 
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does occur; that statistical analysis of the tests of biodegradation of plastic containing the ECM 

additive proves that the plastics themselves (and not simply the ECM additive) biodegraded by 

statistically significant amounts; and that the so-called “priming effect” (wherein only the 

additive is said to biodegrade) is not applicable in the anaerobic context and, in any event, is 

refuted by the evidence of plastic biodegradation in the 30+ tests of the ECM containing plastics 

that he reviewed. (RPFF ¶¶ 187–8, 1810, 1855–56, 2021, 2025–27). 

Dr. Barlaz also testified to direct familiarity with the testing labs that performed tests on 

ECM additive containing plastics, Eden Labs and Northeast Labs, confirmed the propriety of 

their testing methods, and explained that the D5511 tests performed there are appropriate tests to 

determine whether the ECM additive predictably causes biodegradation of plastics in landfills. 

(RPFF ¶¶ 2211–16, 2430–31). Dr. Ryan Burnette, a biochemist, explained the mechanism of 

action by which microbial life attracted by the ECM additive to plastics biodegrade those 

plastics, identifying in detail the precise species of microbial life that are in landfills which 

produce enzymes known to biodegrade plastics and the precise role played by the ECM additive 

in attracting that life (bacteria and fungi), enabling them to affix themselves to the plastic, 

facilitating their formation of colonies, and resulting in the production by those life forms in 

those colonies of specifically identified enzymes scientifically documented to break down the 

carbon chains of plastics and result in the dissolution of them (biodegradation). (RPFF ¶¶ 202, 

204, 2040, 2050, 2071, 2087-91, 2117, 2120). 

Dr. David Stewart, a survey expert, testified concerning the telephone surveys with live 

interviews he caused to be conducted of 400 randomly selected and age-adjusted respondents 

concerning the extent to which the public (and, in a second survey, plastic company purchasers 

of the ECM additive), was aware of the ECM claims, had a common understanding of the term 
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biodegradation, and had a common view of the time plastics take to biodegrade in nature, (RPFF 

¶¶ 217–55, 980–81, 997). He concluded that there was no common awareness or common 

definition among even a significant minority of respondents. Dr. Stewart also evaluated the 

Google Consumer Surveys performed by Dr. Shane Frederick for Complaint Counsel, 

concluding those surveys to be incompetent for failure to satisfy the seven accepted principles of 

survey research. (RPFF ¶¶ 217, 611). Dr. Stewart additionally testified about the APCO and 

Synovate surveys referenced as a basis for the One Year Rule specified in the FTC’s Green 

Guides, deeming both incompetent. (RPFF ¶ 805). 

ECM moved this Court for leave to call a surrebuttal expert, Dr. Grossman, a colleague 

of Complaint Counsel expert Dr. Stephen McCarthy, who teaches in the same department at 

UMass Lowell as Dr. McCarthy and is a professor of plastics engineering and a patent attorney. 

This Court ruled that Dr. Grossman not be permitted to testify in surrebuttal.5

 Had he testified, 

Dr. Grossman would have refuted key sections of Dr. McCarthy’s scientifically erroneous 

testimony and revealed additional key inconsistencies in his testimony as compared to the patent 

he swore to be true and complete to the United States Patent and Trademark Office. An offer of 

proof for the reviewing authority was made, consisting of the report and affidavit of Dr. 

Grossman, which contains the substance of what he would have testified. (Tr. 2821). 

1. Dr. Ranajit Sahu 

Dr. Ranajit “Ron” Sahu, Ph.D. has more than twenty years of experience in 

environmental, mechanical, and chemical engineering. (RPFF ¶ 164). Dr. Sahu obtained his 

M.S. and Ph.D. in Mechanical Engineering from Caltech in Pasadena, CA. (RPFF ¶¶ 152, 155). 

                                                             5 See In re ECM Biofilms, Order on Respondent’s Combined Motion for Sanctions, To 

Exclude Expert Witness, and for Leave, Dkt. No. 9358 (July 23, 3014). 
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Dr. Sahu studied polymer chemistry as part of his undergraduate and graduate coursework in 

material sciences (requisite to his degrees in mechanical engineering). (RPFF ¶¶ 153–54, 156). 

As a consultant and researcher, Dr. Sahu has been involved in, inter alia, landfill containment 

and remediation, emissions studies, and plastic polymer degradation with a focus on 

containment. (RPFF ¶¶ 168–72). He has worked for multinational engineering and technical 

firms like Parsons Corporation. (RPFF ¶¶ 161–63, 166). He has held various adjunct teaching 

positions at several California Universities including UCLA, UC Riverside, Loyola Marymount 

University, USC, Cal State Fullerton, and Caltech. (RPFF ¶ 174). 

Dr. Sahu consults for private and government clients, including the U.S. EPA, the U.S. 

Department of Justice, and the states of New York, New Jersey, Connecticut, Pennsylvania, and 

New Mexico, among others. (RPFF ¶ 173). Concerning polymer science, Dr. Sahu has 

performed numerous projects over the past sixteen years involving aspects of polymer behavior 

in the environment. (RPFF ¶¶ 165–67). Some of those projects included plastics compatibility 

with fuels, safety issues related to plastics and fire, and environmental containment issues like 

permeation. (Sahu, Tr. 1740). Those projects required a well-developed knowledge of plastics 

chemistry, morphology, and function. (Sahu, Tr. 1740–41). 

Dr. Sahu supported his opinion in this case not only with his knowledge of chemistry and 

material science but also with peer reviewed literature, much of which is quoted in his expert 

report. (RX 855 (Sahu, Rep.)). He reviewed hundreds of scientific publications concerning the 

degradability of plastic polymers and the biological mechanisms that support same. (RPFF ¶¶ 

1632–33, 1729). Dr. Sahu reviewed all of the relevant tests concerning ECM plastics, and 

reviewed all available underlying raw data. (RPFF ¶ 1632). He contacted laboratories as part of 

his research on testing methodologies. 
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Dr. Sahu offered an opinion on the biodegradability of plastics. (RPFF ¶ 1731). 

Specifically, he testified that conventional plastics are capable of biodegradation, although at 

slow, almost negligible rates. (RPFF ¶¶ 1731–32). He explained that the ECM additive 

accelerates the natural biodegradation mechanisms for those plastics and creates additional weak 

points in the plastic that facilitate biodegradation. (RPFF ¶¶ 1722, 1724–27) He examined the 

relevant test data in this case, and he concluded that competent and reliable evidence proves that 

the ECM additive substantially accelerates plastics biodegradation, creating “biodegradable” 

polymers. (RPFF ¶ 1809) 

2. Dr. Morton Barlaz 

Dr. Morton Barlaz, Ph.D., has a B.S. in Chemical Engineering, and an M.S. and Ph.D. in 

Civil and Environmental Engineering. (RPFF ¶ 187). The academic focus of his graduate 

degrees was on biodegradation in landfills. (RPFF ¶ 188). He is the head of the Department of 

Civil, Construction, and Environmental Engineering at North Carolina State University. (RPFF 

¶¶ 185–86). He has published at least 115 articles in the peer reviewed literature, most of which 

concern landfill science, biodegradation, landfill gas, or similar issues related to waste disposal 

and material degradation. (RPFF ¶ 189). Dr. Barlaz has been involved in researching solid waste 

issues since 1983. (RPFF ¶¶ 186, 191–95). An award-winning professor and researcher, Dr. 

Barlaz has also served as an editor for two prominent journals in the field of waste management 

and environmental engineering. Dr. Barlaz has been hired by the EPA as an expert in the fields 

of waste management and biodegradation. (RX 853 (Barlaz, Rep. at 27–8)). As a leading global 

authority in the field of waste management, Dr. Barlaz has advised Complaint Counsel’s own 

witness (Dr. Tolaymat) on issues of biodegradation. (RPFF ¶¶ 197–200). 
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Dr. Barlaz offered an expert opinion concerning biological activity in modern landfills, 

finding landfills not to be “dry tombs” but to be replete with biological activity. (RPFF ¶¶ 1810, 

1833, 1846-–56, 1860–61). Dr. Barlaz explained that the amount of biological activity in most 

U.S. landfills is substantial, as evidenced by the significant rates of methane production in 

landfills across the country. (RPFF ¶¶ 1836–37, 1840–41, 1846–49). Dr. Barlaz rejected many 

aspects of Complaint Counsel’s landfill expert, Dr. Tolaymat’s opinion, finding Dr. Tolaymat’s 

discussion of “dry tomb” landfills to be misleading and erroneous. (RPFF ¶¶ 1860–61). 

Dr. Barlaz also offered an opinion concerning the biodegradation testing performed on 

ECM plastics. (RPFF ¶¶ 1965–69). Dr. Barlaz performed a detailed statistical analysis of test 

data provided by laboratories that tested ECM plastics. (RPFF ¶¶ 1968, 1973, 1976–93). He 

testified that test evidence showing biodegradation of plastics infused with the ECM additive 

was of the same kind and quality of evidence upon which competent experts in the field often 

rely. (RPFF ¶¶ 1694–65, 1967–69). He concluded that, based on the data, the ECM infused 

plastics had clearly biodegraded far in excess of any amount that could be attributed solely to the 

additive or the test environment. (RPFF ¶¶ 1972, 1978, 1984, 2000–02). He testified that the 

D5511 tests performed on the ECM additive wherein biodegradation of the additive containing 

plastics was shown were appropriate predictors of biodegradation of those same plastics in 

landfills. (RPFF ¶¶ 1906–09). He concluded, therefore, that competent and reliable scientific 

evidence exists showing that ECM plastics are biodegradable in landfills. (RPFF ¶ 2001). 

3. Dr. Ryan Burnette 

Dr. Ryan N. Burnette, has a B.S. in Biochemistry, with minors in chemistry and 

environmental science, and a Ph.D. in Biochemistry and Molecular Biology—all from Virginia 

Tech’s Department of Biochemistry and the Fralin Biotechnology Center at V.A. Tech. (RPFF 
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¶¶ 202, 204). He was an NIH fellow at Vanderbilt University’s School of Medicine in the 

Department of Molecular Physiology and Biophysics. (RPFF ¶ 207). His biochemistry studies 

at Virginia Tech focused on biochemistry in the Department of Biochemistry which was 

commonly termed the “anaerobe lab,” one of the nation’s oldest and well-respected anaerobic 

microbiology departments, where he focused his research on signal transduction in anaerobic 

facultative bacteria. (RPFF ¶¶ 205–06, 209; Burnette, Tr. 2365). 

Dr. Burnette has worked as an environmental consultant for multi-national companies 

like Hatcher-Sayre, Inc. (RPFF ¶ 211). He has performed substantial work in industrial, 

commercial, and landfill environments characterizing soil and groundwater. (RPFF ¶ 211). He 

was worked as a scientist on EPA superfund landfill establishment sites and remediation of 

same. He has been hired by the CDC and foreign governments. (RPFF ¶¶ 213–14). 

Dr. Burnette regularly consults on issues of microbiology, including anaerobic 

microbiology. (RPFF ¶¶ 212–14). He has worked in microbiology labs across the country 

concerning issues of biological contamination, containment, and remediation. (Burnette, Tr. 

2366–67). He has been hired by pharmaceutical corporations to address safety and containment 

issues related to “live” therapies like vaccinations. (RPFF ¶¶ 213–14; Burnette, Tr. 2367–68). 

Dr. Burnette’s work experience and training has afforded him a broad expertise in the pathology 

of microorganisms and how bacteria interact with their environment. Almost none of his work 

(perhaps just 2%) involves serving as a consultant in legal cases. (Burnette, Tr. 2370). 

Dr. Burnette offered an opinion concerning the various laboratory test environments used 

to assess biodegradation of materials. He explained that the test environments likely include 

many of the same microbiological species that would be found in a Municipal Solid Waste 

landfill and, so, it was appropriate to extrapolate data from the lab test into the landfill 
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environment. (RPFF ¶ 2074). Dr. Burnette also testified that the closed-system laboratory test 

has limitations, including the likelihood that microorganisms may die off or become ineffective 

for reasons that would not apply in the natural landfill environment. (RPFF ¶¶ 2041, 2043, 

2079–93). Finally, he identified many species and enzymes capable of biodegrading plastics, 

and he explained that the test environment may actually lack the ecological depth to properly 

measure the full biodegradable potential of a material under narrow, controlled conditions. 

(RPFF ¶¶ 2045–59, 2070–73). Dr. Burnette was therefore of the opinion that test environments 

like the D5511 are competent and reliable to measure biodegradation in shorter tests, but the 

amount of biodegradation that eventually occurs in the natural setting is likely to be greater and 

continual. (RPFF ¶ 2042). 

4. Dr. David Stewart 

Dr. David Stewart is the President’s Professor of Marketing and Law at Loyola 

Marymount University. (RPFF ¶ 218). He has served as a tenured member of the faculty and in 

various administrative roles at Vanderbilt University, the University of Southern California, and 

the University of California, Riverside. (RPFF ¶¶ 222–24). He has served on the editorial 

boards of twenty journals and regularly reviews all manuscripts submitted. (RX 601 (Stewart, 

C.V.)). He is the current editor of the Journal of Public Policy and Marketing and he is the past 

editor of the Journal of Marketing and the Journal of the Academy of Marketing Science. (RPFF 

¶¶ 229–30). 

Dr. Stewart holds three academic degrees in psychology, including a Ph.D. in personality 

psychology from Baylor University. (RPFF ¶¶ 219–20). His research has extensively examined 

how consumers and managers search for and use information in decision making, effectively 
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communicate with consumers, employ methods for the study of consumers and their behavior, 

and adopt effective and efficient marketing programs. (RX 601 (Stewart, C.V.)). He has taught 

courses to undergraduates, MBA students, Ph.D. students, and practicing managers for over 

thirty years. (RPFF ¶¶ 225–26). His expert opinions in the fields of consumer behavior, 

branding, marketing communications, marketing strategy, deceptive advertising, and intellectual 

property have been accepted and credited by the Federal Trade Commission and in Federal and 

State Courts. (RPFF ¶¶ 245, 252–54). In the late 1980’s, a survey that he designed and 

implemented for the FTC in connection with a deceptive advertising case against Kraft was 

credited by the ALJ and cited by the full commission in its decision. (RPFF ¶¶ 246–47). He has 

also been retained by the FTC in cases against Novartis, POM Wonderful, QVC, Neurologic 

Labs, and John Beck. (RPFF ¶¶ 248–50). He has also been retained by Respondents in prior 

FTC matters, including Pantron, Schering, and Guaranty Life. (RPFF ¶ 251). 

Dr. Stewart was asked to evaluated consumer impression of the unqualified 

“biodegradable” claim, among other claims. He was asked to evaluate the APCO and Synovate 

surveys, which the FTC relied upon in fashioning the Green Guides. (RPFF ¶ 805). He also 

provided an opinion concerning Dr. Shane Frederick’s work, which included the use of a 

fundamentally and fatally flawed Google Consumer web application. (RPFF ¶¶ 598–99, 605–

71). 

Dr. Stewart discussed the survey results from his own well-designed and conducted 

telephonic survey. (RPFF ¶¶ 799–1038). He explained that consumers lack any consistent 

definition of the term biodegradable at issue in this case and share no common notion as to the 

rate at which plastics biodegrade. (RPFF ¶¶ 1004, 1009–12, 1025–26). He testified that Dr. 

Shane Frederick’s survey results were flawed and unreliable. (RPFF ¶¶ 598–99, 605–71). 
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Finally, he explained that the APCO and Synovate studies were flawed and unreliable. (RPFF ¶¶ 

550, 571, 661). 

B. Respondent’s Fact Witnesses 

1. Robert Sinclair (ECM) 

Robert “Bob” Sinclair is ECM’s President and Chief Executive Officer. (RPFF ¶¶ 70, 

72). Mr. Sinclair explained that ECM does not market or sell any product to any consumer. 

(RPFF ¶ 387). Rather, ECM markets and sells only one product, the ECM additive, and only to 

sophisticated plastic manufacturers. (RPFF ¶¶ 299, 365, 370, 392, 398). Indeed, a consumer has 

no use for the ECM additive because the additive can only be used during the manufacturing 

process of a plastic product. (RPFF ¶¶ 299). There is no way for consumers to purchase the 

ECM additive, which is not available online, e.g., via Amazon.com, for public purchase. (RPFF 

¶¶ 361–62, 367). ECM’s customers often have in-house counsel or outside counsel. (RPFF ¶ 

416). They also usually either employ plastic engineers or are owned by a plastic engineer. 

(RPFF ¶¶ 417–19). Mr. Sinclair explained that no consumer can simply walk into a store front to 

purchase the additive, or even place an order online. (RPFF ¶ 361). ECM customers must 

directly contact ECM in order to purchase the additive, which can be done via facsimiles, emails, or telephone calls. (RPFF ¶ 362). 

Mr. Sinclair explained the extensive relationship that ECM must develop with each 

potential new customer before the customer actually decides to purchase the ECM additive. 

(RPFF ¶¶ 301–08). ECM’s new customers usually become aware of the ECM additive through 

others in the plastics industry, articles in trade magazines, or discussions at trade shows. (RPFF 

¶¶ 305–07). After a potential customer initially contacts ECM to inquire about the additive, 
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In re ECM Biofilms, Dkt. No. 9358 

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ECM provides the potential customer with a packet of information. (RPFF ¶ 353). Mr. Sinclair 

often provides the McLaren/Hart report and other materials to ECM’s potential customers to help 

the customer determine for itself whether the ECM additive is sufficient for the manufacturer’s 

purposes. (RPFF ¶¶ 353–54, 356). Mr. Sinclair invited customers to perform independent 

testing of the ECM additive, corroborated by the record which reveals in excess of 33 

independent tests performed by plastic company purchasers of the ECM additive. (RPFF ¶ 403). 

Prospective ECM customers were given, free of charge, a small sample of the ECM additive in 

order to test the additive and make sure that the additive was usable with the manufacturer’s 

equipment and products. (RPFF ¶ 404). Mr. Sinclair works with customers to help customers 

understand how properly to integrate the ECM additive into their products. (RPFF ¶¶ 451–52). 

Once all of the potential customer’s concerns and questions were answered, which took between 

six months and several years, the customer would then purchase the ECM additive. (RPFF ¶ 

308). ECM provides a certificate of biodegradability to each customer if the customer desires 

and if the customer signs a statement stating that it will follow ECM’s detailed manufacturing 

instructions for the additive. (RPFF ¶¶ 1344–45). ECM’s certificate of biodegradability certifies 

that the plastic containing the ECM additive is “biodegradable” under the ASTM definition of 

“biodegradable,” which definition reads: 

"A degradable plastic is defined as a plastic that is designed to undergo a 

significant change in its chemical structure under specific environmental 

conditions resulting in a loss of some properties that may vary as 

measured by standard test methods appropriate to the plastic and the 

application in a period of time that determines its classification. A 

Biodegradable Plastic is defined as a degradable plastic in which the 

degradation results from the action of naturally occurring microorganisms 

such as bacteria, fungi and algae.” 

(RPFF ¶¶ 1346–47). 
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In re ECM Biofilms, Dkt. No. 9358 

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Until three years ago, ECM represented that plastics manufactured with the ECM 

additive would biodegrade in between nine month and five years. (RPFF ¶ 309). That statement 

was based on the scientific conclusions supplied to ECM’s prior owner, Patrick Riley. (RPFF ¶ 

49). The prior owner performed aerobic and anaerobic testing of the ECM additive and 

concluded, based on the scientific results, that the additive would cause biodegradation of 

plastics within 9 months to 5 years. (RPFF ¶¶ 45-48). Robert Sinclair also performed aerobic 

and anaerobic testing of the ECM additive via placement of additive infused plastics in drums 

where aerobic and anaerobic testing took place as well as directly in garden plots, and witnessed 

the biodegradation of those plastics within the 9 month to 5 year time frame. (RPFF ¶¶ 51–54). 

The nine month to five year statements were never intended to be definitive statements of 

biodegradation rates, but were rather a discussion starter and a way to distinguish the ECM 

additive from quickly degrading and competing products such as oxo-degradable and 

compostables. (RPFF ¶ 309). The nine month to five year claims was qualified in the course of 

interactions during the six month to two year time frame of new customer consideration of the 

product. (e.g., RPFF ¶ 474; RX 35–77). When customers inquired about the rate of 

biodegradation of their specific plastics if infused with the ECM additive, ECM explained that 

the specific rate of biodegradation varied greatly depending on a number of factors arising from 

where the plastic ends up after disposal and that, depending on those factors, could be much 

longer than 5 years. ECM permanently discontinued making the 9 months to five year claim 

three years ago. (RPFF ¶ 315). ECM now states that plastic containing the ECM additive “will 

biodegrade in any biologically-active environment (including most landfills) in some period 

greater than a year.” (RPFF ¶ 318). ECM did not lose any customers when it changed its 
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qualifier from nine months to five years to greater than one year.6 Mr. Sinclair explained that 

ECM did not lose business when it changed its qualifier because plastic manufacturers simply do 

not care how long it takes plastic containing the ECM additive to biodegrade so long as the 

plastic in fact biodegrades. (RPFF ¶¶ 322, 341, 360, 396). ECM customers want to know that 

plastic containing the ECM additive will biodegrade but do not want plastics containing the 

additive to biodegrade too quickly, because rapid biodegradation of plastics is associated with 

problems of plastic utility in the market, rendering the plastic’s shelf life insufficient for 

commercial purposes. (RPFF ¶¶ 322, 341–42, 360, 396). 

2. Kenneth Sullivan (ECM) 

Ken Sullivan is ECM’s Chief Financial Officer. (RPFF ¶¶ 86–7). Mr. Sullivan testified 

that ECM’s customers are almost always much larger than ECM. (RPFF ¶ 395). Mr. Sullivan 

also testified that bioplastics, which compete with ECM plastics, come at a substantially greater 

cost than plastics containing the ECM additive. (RPFF ¶¶ 339–40, 388). Furthermore, Mr. 

Sullivan explained that companies choosing to invest in bioplastics must change their entire 

manufacturing process to accommodate the use of the new natural resins. (RPFF ¶¶ 333–34). 

ECM’s customers purchase the ECM additive in part because it provides them with a 

biodegradable product without many of the drawbacks that come from bioplastics. (RPFF ¶¶ 

329–31). Therefore, ECM offers a cost-effective means to achieve biodegradable plastics. 

(RPFF ¶¶ 41, 338–39). 

Mr. Sullivan also testified regarding ECM’s marketing efforts. (RPFF ¶¶ 301-07). ECM 

employs no sale force, but only one sales manager. (RPFF ¶¶ 351–52). Mr. Sullivan reiterated 

                                                             6 Compare RX 35-77 (typical emails sent to all customers advising of the change to 

qualifiers), with CCX 234 (orders by customer by year) (the content of CCX 234 is in camera;

but the general discussion of customers is not). 
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that ECM does not target consumers in any of its advertising or marketing, and that ECM’s 

customers are sophisticated industrial manufacturers. (RPFF ¶ 298). In all, ECM’s advertising 

budget is less than $12,000 per year, which expense is primarily for website maintenance. 

(RPFF ¶ 301). ECM has no advertising plan and does not purchase any advertisements. (RPFF 

¶¶ 302–04). 

3. Thomas Poth (Eden Laboratories) 

Thomas Poth owns and operates Eden Laboratories (“ERL”) in Albuquerque, New 

Mexico. (RPFF ¶ 115). He runs ERL alongside Brian Essau, a Ph.D. in biochemistry. (RPFF ¶¶ 

123-24). Mr. Poth and Dr. Essau performed a number of biodegradation tests of ECM amended 

plastics, including D5511 tests and similar tests modeled after the D5511 standard. (RPFF ¶¶ 

406, 2218–19, 2241–42, 2259–60, 2284–85, 2303–04, 2322–23, 2346–47, 2363–65). In many 

(but not all) of those tests, the ECM additive was shown to produce a plastic that biodegraded 

substantially when compared with a negative control. (RPFF ¶¶ 2239–40, 2257–58, 2283, 2302, 

2321, 2344–45, 2362, 2384–85). 

Mr. Poth testified at the hearing and described, inter alia: his testing protocol; ERL’s 

equipment and facilities; ERL’s calculation of biodegradation; ERL’s inoculum; and ERL’s 

standard operating procedures with respect to biodegradation testing. (RPFF ¶¶ 2184–2210). Dr. 

Mort Barlaz testified that he visited ERL’s laboratory (unrelated to this case), and that he had no 

reason to doubt that ERL’s testing was reliable. (RPFF ¶¶ 2211–16). 

4. Alan Johnson (Northeast Laboratories) 

Alan Johnson owns and operates Northeast Laboratories, Inc., in Berlin, Connecticut. 

(RPFF ¶¶ 133–34, 2386–87). Northeast Labs (“NE Labs”) performed a number of 
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biodegradation tests of ECM amended plastics, including D5511 tests based on the ASTM 

D5511 standard. (RPFF ¶¶ 2456–57, 2477–78, 2506–07, 2523–24, 2533-34, 2549–50, 2558–59, 

2580–81, 2602–03, 2615–16). NE Labs designed its test protocol based on the input from Dr. 

William Ullman, a Ph.D. in microbiology and the former Director of the State of Connecticut’s 

Public Health Laboratory. (RPFF ¶¶ 2396–98; Johnson, Tr. 1562). In many (but not all) of 

those D5511 tests, the ECM additive was shown to produce a plastic that biodegraded 

substantially when compared with a negative control. (RPFF ¶¶ 2474–76, 2500–05, 2521–22, 

2530–32, 2548, 2557, 2577–79, 2600–01, 2611–12, 2625). 

Mr. Johnson testified at the hearing and described, inter alia: NE Lab’s testing protocol; 

NE Lab’s equipment and facilities; NE Lab’s calculation of biodegradation; NE Lab’s inoculum; 

and its standard operating procedures with respect to biodegradation testing. (RPFF ¶¶ 2399–

2429). 

5. Dr. Timothy Barber (Environ Corp.) 

Dr. Timothy Barber is a principal in the global research company Environ. (RPFF ¶ 

104). He has a B.S. in chemistry and a Ph.D. in marine science with a specialization in 

chemistry. (RPFF ¶¶ 93–4; Barber, Tr. 2004). Dr. Barber is a well-qualified and credentialed 

scientist in the field of environmental science. (RPFF ¶¶ 95–109). Dr. Barber designed 

biodegradation studies that he then performed on plastics infused with the ECM additive. (RPFF 

¶¶ 549, 2687). Based on the results of that testing, which used various endpoints to assess 

biodegradation, Dr. Barber concluded repeatedly that the ECM additive rendered plastics 

biodegradable. (RPFF ¶¶ 2701–03). He also conveyed that conclusion to ECM customers based 

on his testing. (RPFF ¶¶ 2701–03. 
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Dr. Barber testified at the hearing concerning the reports given to ECM, explaining why 

his laboratory results were sufficient to establish that the ECM amended plastics had 

biodegraded. (RPFF ¶¶ 2670, 2684–86, 2688–91). Dr. Barber also explained why closedsystem laboratory tests are often inadequate to test for biodegradability long-term. (RPFF ¶¶ 

2673–83). Dr. Barber also explained why certain types of plastics (e.g., polystyrene foams) were 

not conducive to his testing protocol. (RPFF ¶¶ 2901–05). 

C. Complaint Counsel’s Experts 

1. Thabet Tolaymat 

Dr. Tolaymat is an agency employee for the United States Environmental Protection 

Agency. (RPFF ¶ 2709). Not an independent expert, he is an employee of a sister government 

agency. (RPFF ¶ 2709). Dr. Tolaymat worked as an “expert” witness in this case while paid by 

the EPA. (RPFF ¶¶ 2710–11). He is not a senior scientist in EPA with expertise in landfill 

gases, although the EPA has scientists who are. (RPFF ¶¶ 2714–15). Although Dr. Tolaymat’s 

opinion with respect to landfill activity ostensibly contradicts the EPA’s published documents on 

methane production, Dr. Tolaymat did not consult with anyone at the EPA before authoring his 

report. (RPFF ¶ 2712). He did not discuss his opinion or testimony with a single colleague in 

the EPA. (RPFF ¶ 2717). Despite having been retained in this case to assist Complaint Counsel 

since 2010, Dr. Tolaymat spent just eighty (80) total hours on the case before testifying at his 

deposition. (RPFF ¶¶ 2719–20) 

As discussed below, Dr. Tolaymat testified inconsistent with Complaint Counsel’s other 

experts, testified inconsistently with ECM’s expert Dr. Barlaz (who Dr. Tolaymat considers to be 

an expert in the field), contradicted himself repeatedly, and demonstrated a general lack of 

sophisticated knowledge in the relevant scientific areas. 
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2. Steven McCarthy 

Dr. Steven McCarthy is a professor at UMass Lowell in Massachusetts. (McCarthy, Tr. 

359). Dr. McCarthy testified for Complaint Counsel as to the ability of ECM amended plastics 

to biodegrade in a landfill. (McCarthy, Tr. 359–690). As explained in detail below (supra at 

147), Dr. McCarthy has materially changed his position on the science throughout this case, 

creating a moving target with virtually no citation to apposite peer reviewed scientific literature 

and a preference for broad conclusory statements over detailed scientific explanation. (RPFF ¶¶ 

1354–1581). Dr. McCarthy’s theoretical criticisms of ECM plastics are unsupported by basic 

science or peer reviewed literature. (RPFF ¶¶ 784, 786–87, 789, 805–07, 1481–93, 1520–31, 

1565–66). Dr. McCarthy has attempted to impose standards on ECM plastics that he does not 

require of himself when supporting his own competing biodegradable technologies and does not 

follow in his own published scientific research on biodegradable plastics. (RPFF ¶¶ 1449–80, 

1539–64). Dr. McCarthy failed to consider whole areas of data when fashioning his expert 

opinion. (RPFF ¶¶ 1490–93, 1567-68). He adopted a litigation definition for the term 

“biodegradable” given to him by Complaint Counsel that is not supported by the science but that 

conveniently does mirror the Green Guides’ definition. (RPFF ¶¶ 1360–69, 1532–34). He is a 

biased party with financial interests in the outcome of this litigation, and his testimony reflected 

that bias. (RPFF ¶¶ 1396–1448). 

3. Shane Frederick 

Dr. Shane Frederick testified as an “expert” witness for Complaint Counsel in the areas 

of consumer impression. (RPFF ¶ 275). Dr. Frederick attempted to validate the Commission’s 

prior reliance on flawed consumer surveys through a new survey methodology, his Google 

Consumer Surveys. (RPFF ¶ 279, 826, 904–05). Dr. Frederick relied on a single question 
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approach via Google Consumer Survey, a flawed, untested, and unreliable approach that has 

never been used before in litigation of any kind to support a legal determination of consumer 

impression. (RPFF ¶¶ 278, 906, 979–88). Dr. Frederick chose to rely on such methods in an 

effort to save costs, which may have been motivated by the fact that Complaint Counsel paid him 

on a flat fee basis. (RPFF ¶¶ 895–903). Dr. Frederick’s survey methodology suffered from a 

number of fatal flaws including, for example, the fact that he failed to blind his coders, failed to 

collect essential screening information from survey respondents, and asked only one question to 

each survey respondent. (RPFF ¶¶ 907–86). As discussed in more detail below, Dr. Frederick’s 

so-called “survey” was a biased attempt to support Complaint Counsel’s case, rather than to 

ascertain consumer impression objectively. (RPFF ¶¶ 279, 826, 904–05). 

4. Frederick Michel (Rebuttal) 

Dr. Frederick Michel testified in rebuttal to testimony offered by ECM experts Drs. Sahu 

and Burnette. (RPFF ¶ 281). Dr. Michel had been retained by Complaint Counsel since at least 

2012, and Complaint Counsel had relied in this case on his single study of plastics in the market 

since at least February 2014. (RPFF ¶¶ 2997–3003). That single study was based on a test 

product contributed to Dr. Michel by an ECM competitor, Myers Company, (RPFF ¶¶ 2939, 

2944–49), and said to contain an ECM additive (but there is no chain of custody present and no 

proof that the additive was properly manufactured). (RPFF ¶¶ 2916, 2941–44, 2950–54). 

Complaint Counsel first disclosed Dr. Michel as a “rebuttal” witness after the time ECM could 

have amended its own expert reports.7

 Dr. Frederick Michel testified almost exclusively based 

on the single study that he performed. (RPFF ¶¶ 907–86). Dr. Michel’s study was an ASTM 

                                                             7 See In re ECM Biofilms, Order on Respondent’s Combined Motion for Sanctions, To 

Exclude Expert Witness, and for Leave, Dkt. No. 9358 (July 23, 3014).
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D5511 test that he conducted on various commercial plastics. (RPFF ¶¶ 1616, 1772). Although 

he published his study in the peer reviewed literature, Dr. Michel failed to disclose financial 

interests with competitors of ECM, which would have constituted an actual or potential conflict 

of interest under the publisher’s conflicts policy. (RPFF ¶¶ 2963–83). That failure to disclose 

information to the peer-reviewer was a violation of the peer reviewed publication’s, Elsevier’s, 

rules governing the submission of peer reviewed literature. (RPFF ¶¶ 2957–60). Moreover, the 

peer reviewers never reviewed raw data from Dr. Michel’s study, but only reviewed the 

manuscript that included Dr. Michel’s summary of information. (RPFF ¶¶ 2960–62). Dr. 

Michel chose to run a D5511 gas evolution test to measure anaerobic biodegradability of the 

ECM plastic. (RPFF ¶¶ 1616, 1772). He also testified that experts in the field rely on gas 

evolution tests like the D5511 test to determine biodegradability. (RPFF ¶¶ 1775, 2925). The 

Michel test yielded inconclusive results. It showed no biodegradation of the test plastic (not 

even an amount equal to the biodegradation of the additive), but Michel undertook no effort to 

determine the precise cause of test failure, thus not ruling out mis-manufacture of the test plastic, 

death of the microbes in the inoculum, or the presence of a contaminant, such as an antimicrobial agent, in the test plastic itself, etc. (RPFF ¶¶ 2991–96). The inconclusive Michel test 

is therefore unreliable and cannot reasonably be credited as competent evidence in this 

proceeding. 

D. Complaint Counsel’s Fact Witnesses 

Complaint Counsel elected not to call a single fact witness at hearing in support of its 

case, depending solely on deposition transcripts for certain witnesses, including mostly ECM 

customers. (RPFF ¶ 257). ECM objected on due process grounds, among others, explaining that 

while the FTC Rules of Practice technically permit the introduction of deposition testimony, the 
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sheer volume of fact depositions (20), in locations around the country (e.g., Honolulu, San 

Francisco, Minneapolis, Michigan, Connecticut, New York, Ohio, etc.), rendered it nearly 

impossible for a small corporation like ECM to afford legal representation at each deposition. 

Knowing that ECM was unable to provide attorneys at depositions, or that ECM was forced to 

appear telephonically, Complaint Counsel elected not to call any of its fact witnesses and, 

instead, opted to introduce what they (erroneously) considered one-sided testimony. (RPFF ¶¶ 

256, 258). Although testimony of an out of court fact witness is entitled to little, if any, weight, 

when the witness could have been called to appear at trial,8 in point of fact on the relevant 

question of the basis for purchases of the ECM plastic, almost every witness testified (even in the 

face of leading examinations) that it bought the ECM additive for infusion in plastics because it 

rendered the plastics biodegradable, not because it achieved biodegradation within any set time 

or by a set rate. (RPFF ¶¶ 605–725). 

Deposition testimony derived from examination by counsel from one party only is 

viewed with skepticism by the courts, particularly, as here, where Complaint Counsel relied 

almost exclusively on leading inquiries, not affording the witness an opportunity to present all 

relevant background facts and circumstances. Direct, in the absence of cross, has always been 

viewed as dubious.9

 When out of court witnesses are available to testify but are not called, 

Courts routinely give little, or no, weight to the out of court statements in the deposition 

transcripts.10 That is in no small part because it is critical for the finder of fact, here the 

                                                             8

Pub. Serv. Co. of N.M., 11 FERC ¶ 63,002 (1980) (Harfeld, ALJ) (finding that although 

certain hearsay statements (i.e., depositions) are not excludable from administrative proceedings, 

they may be given little weight.) 

9

 Id

10 Id.
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Administrative Law Judge, to see the witness testify and assess his or her credibility on the stand 

to determine the extent to which the witness is credible.11 By calling no fact witnesses in support 

of its case, Complaint Counsel has denied the Administrative Law Judge the requisite basis to 

make critical character findings based on observation of the witness testifying, as well as the 

Administrative Law Judge’s opportunity, and opposing counsel’s, to make inquiry of the witness 

at trial on points for which elaboration would reveal factual underpinnings and responses 

indicative of credibility not arising from one-sided questioning at deposition.12

III. ARGUMENT 

“The determination of whether Respondent’s disseminated false advertisements in 

violation of the FTC Act requires a three-part inquiry: (1) whether Respondent’s disseminated 

advertisements conveying the claims alleged in the Complaint; (2) whether those claims were 

false or misleading; and (3) whether those claims are material to prospective consumers.” In the 

Matter of Pom Wonderful LLC, 9344, 2012 WL 2340406 (F.T.C. May 17, 2012) (Initial Decision 

at 211) (quoting Kraft, Inc. v. FTC, 970 F.2d 311, 313 (7th Cir. 1992)); FTC v. Pantron I Corp., 

33 F.3d 1088, 1095 (9th Cir. 1994); FTC v. Direct Marketing Concepts, 569 F.Supp. 2d 285, 297 

(D. Mass. 2008). In this case, the claims in question are few in number and accompanied by 

claim qualifications, which are further underscored by additional qualifications made by ECM 

president Robert Sinclair before purchases were made by sophisticated plastic manufacturer 

customers. This dialogue resulted in a transformation of the claims away from those listed by 

                                                             11 Trial Practice, 35 Stetson L. Rev. 1139, 1140 (2006) (explaining that thorough crossexamination is necessary to allow the fact-finder to consider the witness’s responses to such 

questions and to ultimately determine the thoroughness and credibility of the witness’s 

testimony) 

12 Id.
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Complaint Counsel in the Complaint to ones that are accompanied by transparent and complete 

revelations concerning the product. ECM claimed that its additive would hasten biodegradation 

of plastics infused with it, but qualified the claim explaining that the rate of biodegradation for 

any piece of plastic was entirely dependent on the location where the plastic came to rest after 

customary disposal, the ambient environmental conditions present there, and the extent to which 

other biodegrading matter was present. (RPFF ¶¶ 378–79, 1080; RX 681 at 61). The 

representations made were neither false nor misleading, particularly in light of the fact that the 

sophisticated customers, the plastics manufacturers that purchased ECM’s products, commonly 

conducted their own testing of the product and did not rely on any ECM claims, beyond that of 

biodegradation, as a basis for purchase but rather depended on the company’s own testing and 

proof of product functionality and biodegradation before making a purchase. (RPFF ¶¶ 1083, 

2129–2885). In the end, given these sophisticated purchasers well-versed in plastics 

manufacture and in testing of the ECM additive, claims made by ECM beyond biodegradation 

had no materiality and, even the claim of biodegradation carried with it little materiality to 

ultimate purchases in those common instances where the plastic manufacturer tested the product 

to determine on its own whether the product caused the company’s own plastic to biodegrade. 

(RPFF ¶¶ 296–739). 

A. Complaint Counsel Has the Burden of Production on Charges in the 

Complaint 

Complaint Counsel has an irreducible burden of production for each element of the 

causes of action they bring in the Complaint. “The burden of production is the obligation to 

come forward with evidence of a litigant’s necessary propositions of fact.” Chicago Bride & 

Iron Co. N.V. v. F.T.C., 534 F.3d 410, 425 (D.C. Cir. 2008) (quotation omitted). Having rested 

its case without presenting a single fact witness in support of its case, Complaint Counsel has 
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failed to meet its fundamental burden of production in support of the charges in the Complaint. 

On that basis, alone, the Complaint can and should be dismissed. See, e.g., FTC v. Tashman, 318 

F.3d 1273, 1283 (11th Cir. 2003) (holding that FTC failed to meet its burden because limited 

testimony presented was not enough). 

B. Complaint Counsel Has The Burden of Proof to Show that ECM Made 

Claims, That those Claims Were False or Misleading, and That the Claims 

Were Material 

 “Counsel representing the Commission . . . shall have the burden of proof, but the 

proponent of any factual proposition shall be required to sustain the burden of proof with respect 

thereto.” 16 C.F.R. § 3.43(a); see also 5 U.S.C. § 556(d) (explaining that “the proponent of a 

rule or order has the burden of proof”). Regardless of the level of substantiation required, the 

FTC will bear the burden of proving advertising claims false or misleading. See Sterling Drug, 

Inc. v. F.T.C., 741 F.2d 1146, 1150 (9th Cir. 1984); Porter & Dietsch, Inc. v. F.T.C., 605 F.2d 

294, 305 (7th Cir. 1979); F.T.C. v. Garvey, 383 F.3d 891, 900 (9th Cir. 2004) (“we put the 

burden of proving falsity or deception on the FTC”). To prove that an advertisement is false or 

misleading, the FTC must show (1) the existence of a “representation, omission, or practice,” 

that is (2) “likely to mislead consumers acting reasonably under the circumstances,” and that (3) 

“the representation, omission, or practice is material.” F.T.C. v. Bronson Partners, LLC, 564 F. 

Supp. 2d 119, 124 (D. Conn. 2008) (citation omitted). Complaint Counsel must prove each 

element of its case by a preponderance of the evidence. See, e.g., In re Adventist Health 

Sys./West, 117 F.T.C. 224, 297 (Apr. 1, 1994) (explaining that “[e]ach element of the case must 

be established by a preponderance of the evidence”); see also In the Matter of POM Wonderful, 

LLC, 2012 WL 2340406, at *171 (F.T.C. May 17, 2012) (noting that “Complaint Counsel has 
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the burden of proving each of the foregoing factual issues by a preponderance of credible 

evidence”). 

Fundamentally, Complaint Counsel has failed to demonstrate that the sophisticated 

customers to whom ECM sells its additive were likely to be misled “under the circumstances.” 

In particular, not even a significant minority of those customers has been shown to have relied on 

any claim made by ECM other than the biodegradability claim, which the evidence proves was 

true. (RPFF ¶¶ 799–1038). In that regard, the evidence in issue comes not from tests ECM 

commissioned but from tests commissioned by those same customers on the very plastics those 

customers infused with the ECM additive. (RPFF ¶¶ 1964–2885). In short, given the lack of 

reliance on any claim made by ECM (even the biodegradation claim because the sophisticated 

customers most commonly performed independent tests of the ECM additive), there is no basis 

in fact, science, or law to conclude that these sophisticated customers were likely to be misled 

under the circumstances.13 Finally, the only issue the evidence reveals was material to ECM 

customers was that of biodegradation. (RPFF ¶¶ 1039–1351). But, again, biodegradation was 

not taken at face value before a customer made a purchase decision. Rather, the record 

establishes that ECM customers tested the ECM product on biodegradation grounds before 

choosing to purchase it for infusion in their plastic products. (RPFF ¶¶ 1039–1210, 1964–2885). 

Consequently, certainly biodegradation was the only subject matter material to a purchasing 

decision by even a significant minority of ECM customers, but any representation of 

biodegradation by ECM was not accepted without independent tests by the customers that, in 

reality, became the predicate for a purchase decision. (RPFF ¶¶ 1039–1210, 1964–2885). 

                                                             13 See, e.g., RPFF ¶¶ 1039–1351. 
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There are two ways the FTC can prove that an advertisement is likely to mislead 

consumers. “One [way] is to carry the burden of proving that the express or implied message 

conveyed by the ad is false. The other [way] is to show that the advertiser lacked a reasonable 

basis for asserting that the message was true.” F.T.C. v. Bronson Partners, LLC, 564 F. Supp. 2d 

119, 135 (D. Conn. 2008) (citing In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648 

(1984)). The FTC must also establish materiality. “A ‘material’ misrepresentation is one that 

involves information that is important to consumers, and that is therefore likely to affect a 

consumer's choice of or conduct regarding a product.” F.T.C. v. Bronson Partners, LLC, 564 F. 

Supp. 2d 119, 135 (D. Conn. 2008) (quoting In Re Kraft, Inc., 114 F.T.C. 40 (1991)); see also

FTC Policy Statement on Deception, Federal Trade Commission (1983)). As explained above, 

the ads in context of the sales presentations by ECM, which involved extensive interaction with 

customers over six months to several years, were between sophisticated parties that shared full 

disclosure of all material facts. (RPFF ¶¶ 297–433, 1039-1351. ECM had at all times a 

reasonable basis for every material statement made to its customers derived from its own testing 

and experience with the product and its customers independent testing and experience with the 

product prior to purchase. (RPFF ¶¶ 1964–2885). 

C. Complaint Counsel Has Failed to Meet Their Burden to Prove that ECM 

Conveyed Implied Biodegradability “Rate” Claims 

Extrinsic evidence includes survey results and other evidence governing how consumers 

perceive certain claims. In Re Kraft, Inc., 114 F.T.C. 40, 121 (1991). The Commission can look 

at: 

Evidence not specifically showing how consumers understood 

the advertisements at issue before us, but showing how consumers might 

ordinarily be expected to perceive or understand representations like those 
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contained in the ads we are reviewing. For example, we might look at the 

dictionary definition of a word to identify the word's common usages. Or we 

might look at principles derived from market research, as expressed by 

marketing experts, which show that consumers generally respond in a certain 

manner to ads that are presented in a particular way, and presume 

that consumer reactions to a particular ad before us would be consistent with 

the general response pattern. Where we apply such marketing principles, we 

will derive them from research presented in references generally accepted as 

reliable in the field of marketing. Such references may be cited by marketing 

experts called to testify in the proceeding. 

In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648 (1984). The Commission may also 

consider evidence of how consumers would interpret an advertisement in a particular manner. 

Id.

ECM spends less than $12,000 per year on advertising, almost all of which is devoted to 

website maintenance. (RPFF ¶ 300).14 ECM’s claims are shared with specific, sophisticated 

customers during the long six month to several years’ pre-purchase negotiations leading to a 

corporate sales agreement between the two entities. Mr. Sinclair credibly testified that the bulk 

of his discussions with customers is through verbal communication, or targeted emails.15 

Brochures and flyers are not shared with the public at large, but dispatched to specific 

corporations who have expressed interest in ECM’s technology. (RPFF ¶¶ 329–432). 

 “Advertising is a form of promotion to anonymous recipients, as distinguished from 

face-to-face communication. In normal usage, an advertisement read by millions (or even 

thousands in a trade magazine) is advertising, while a person-to-person pitch by an account 

executive is not.” First Health Grp. Corp. v. BCE Emergis Corp., 269 F.3d 800, 803–04 (7th 

                                                             14 As is clear from the record, there is literally no evidence in this case that ECM’s claims 

were designed to target end-consumers, that end-consumers have visited ECM’s website, or that 

ECM receives considerable traffic to its website. To the contrary, the website is clearly designed 

for manufacturers of plastics. (RPFF ¶¶ 300–06, 367–69). 

15 See, e.g., CCX 818, at 45, 52–53, 202. 
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Cir. 2001).16 Therefore, an in person statement by a company’s sales team is not 

“advertising.” Zurich Ins. Co. v. Amcor Sunclipse N. Am., 241 F.3d 605, 607 (7th Cir. 

2001). Likewise, statements by a company’s executive made in person to other executives 

cannot be called “commercial advertising or promotion.” First Health Group Corp. v. BCE 

Emergis Corp., 269 F.3d 800, 804 (7th Cir. 2001). Similarly, in order to constitute “promotion,” 

materials must be “disseminated sufficiently.” Coastal Abstract Serv., Inc. v. First Am. Title Ins. 

Co., 173 F.3d 725, 735 (9th Cir. 1999); Seven-Up Co. v. Coca-Cola Co., 86 F.3d 1379, 1384 (5th 

Cir. 1996) (same). 

Concerning claims made directly to, and between, ECM’s customers that were not passed 

through the chain of commerce to a substantial audience, Complaint Counsel’s theory of liability 

creates substantial policy concerns over the reach and scope of the FTC’s jurisdiction. At the 

very least, prudential considerations should govern whether the FTC is empowered to regulate 

the terms of transactions or sales agreements between two sophisticated corporate entities and 

the weight given any such communications which were not “disseminated sufficiently.”

“[I]n determining what claims are conveyed by a challenged advertisement, the 

Commission relies on two sources of information: its own viewing of the ad and extrinsic 

evidence. Its practice is to view the ad first and, if it is unable on its own to determine with 

confidence what claims are conveyed in a challenged ad, to turn to extrinsic evidence.” Kraft, 

Inc. v. F.T.C., 970 F.2d 311, 318 (7th Cir. 1992). Therefore, the FTC does not need to point to 

extrinsic evidence to determine whether an advertisement makes an objectionable claim. 

Generally the FTC’s own view of the advertisement is sufficient. Id. at 319. 

                                                             16 Black’s law definition defines an “advertisement” as “notice given in a manner 

designed to attract public attention.” See Black’s Online Law Dictionary (2d Ed.), available at, 

http://thelawdictionary.org/advertisement/ (last visited September 25, 2014). 
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The FTC must use extrinsic evidence to determine what the claim implies when the claim 

is not “reasonably clear from the face of the advertisement.” F.T.C. v. Bronson Partners, LLC, 

564 F. Supp. 2d 119, 126 (D. Conn. 2008). Similarly, Thompson held that the FTC must have 

extrinsic evidence when “the advertisement itself does not allow [the FTC] to conclude with 

confidence” that the advertisement at issue contains a particular implied claim. 104 F.T.C. 648, 

at ¶ 7. And as another case clarified, “if the language or graphic is susceptible to more than one 

reasonable interpretation . . . the district court must look to consumer data to determine what the 

person to whom the advertisement is addressed finds to be the message.” Time Warner Cable, 

Inc. v. DIRECTV, Inc., 497 F.3d 144, 158 (2d Cir. 2007). 

When an implied claim is at issue, “[t]he Commission will carefully consider any 

extrinsic evidence that is introduced, taking into account the quality and reliability of the 

evidence.” In re Stouffer Foods Corp., 118 F.T.C. 746, 799 (Sept. 26, 1994). Such extrinsic 

evidence includes “reliable results from methodologically sound consumer surveys.” Id. In 

weighing survey evidence, the Commission “looks to whether such evidence is reasonably 

reliable and probative. Flaws in the methodology may affect the weight that is given to the 

results of the copy test or other consumer survey.” Id. (citation omitted). 

In this case, for the vast majority of products that eventually reach end-consumers, 

consumers only receive a “biodegradable” claim, often in the form of a logo or a small stamp on 

the packaging. Using the unscientific positions expressed in the Green Guides, Complaint 

Counsel has inferred that every unqualified “biodegradable” claim is actually a claim that a 

product will fully degrade within one year in the environment. The evidence directly refutes the 

notion that the political definition of “biodegradation” (complete break down into elements in 

nature within one year after customary disposal) matches the scientific definition and that the 
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political definition is commonly accepted by even a significant minority of ECM customers or 

plastics consumers. (RPFF ¶¶ 767–817). 

1. Extrinsic Evidence of High Methodological Quality Reveals that ECM 

Did Not Make Implied Claims Concerning the Rate or Extent of 

Biodegradation 

In order to determine what consumers believe “biodegradable” means, ECM retained the 

services of survey expert Dr. David Stewart, an expert whose surveys have often been credited 

by the ALJs at the agency and by the Commission itself. (RPFF ¶¶ 217–255, 1286). Dr. Stewart 

conducted a well-designed, live telephone interview survey based on established principles of 

survey research that are consistent with the guidelines for survey research offered in litigation as 

articulated in the Manual for Complex Litigation. (RPFF ¶¶ 1105, 1176–78; RX 856, at 16). In 

sum, Dr. Stewart concluded that consumers have no common understanding of the term 

“biodegradable.”17 In fact, consumers were asked “if something is degradable, how long do you 

think it would take for it to decompose or decay?” (RPFF ¶ 1306). In response, 39% of survey 

respondents stated that it depends on the material or type of product. (RX 856 at 25). No other 

single response was offered by more than 6% of the respondents. (RX 856 at 25). As proven by 

Dr. Stewart’s survey, no significant percentage of consumers think that products labeled 

“biodegradable” will degrade within one year or any specific time frame. (RPFF ¶¶ 1300–22). 

No significant percentage of consumers have enough understanding or knowledge of the concept 

of biodegradation to properly assess those claims. (RPFF ¶¶ 1300–22). Therefore, when ECM 

claims that their plastic products are “biodegradable,” ECM is not implying to consumers that 

the products will biodegrade within one year or any other specific time frame or that the products 

                                                             17 See RPFF ¶ 1302 (Ninety-eight percent of the respondents to Dr. Stewart’s survey do 

not believe that there is a uniform rate for materials biodegrading and that the rate really depends 

on the material); Stewart, Tr. 2577. 
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will completely break down into elements found in nature. Indeed, an overwhelming 98% of 

respondents believe that different types of products take different amounts of time to biodegrade, 

decompose, or decay (RPFF ¶ 1322; RX 856 at 26), thus vitiating any notion that consumers 

harbor a common view that plastics of all kinds should achieve a complete break down into 

elements in nature within one year after customary disposal. 

a. Dr. Stewart’s Telephone Survey was Well-Designed, Incorporated 

Open-Ended Clear Questions, and Closely Adhered to Established 

Principles of Survey Research. 

A survey expert whose work has repeatedly been credited by ALJs of the FTC and the 

Commission itself, Dr. David Stewart designed a live interview telephone survey in order to 

determine how consumers who purchase products made from or packaged in plastic actually 

perceive the meaning of the term “biodegradability.” (RX 856 at 15). Phone surveys are the 

most common form of survey used in marketing research. (RPFF ¶¶ 1106–08, 1176–78). The 

primary reason Dr. Stewart opted for a live telephone interview survey is because he was 

interested in “meaning.” (RPFF ¶¶ 1106–08, 1288). In order to understand what people believe 

a term means, particularly a term for which little survey research exists, a competent researcher 

needs a real life interviewer appropriately trained to conduct research. (RPFF ¶¶ 1108–10). This 

survey also assessed the message that consumers take away from claims made by ECM. (RPFF 

¶ 1296; RX 856 at 15). Dr. Stewart’s survey used well-designed, non-leading, and clear openended questions that allowed real consumers to answer in their own words and to provide 

qualifications, contextual information, or other information that established a richer meaning of 

consumer responses than is typically obtained when only closed-ended questions appear (or 

single questions are posed without human interface) in a survey. (RPFF ¶¶ 1293; RX 856 at 15). 
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Dr. Stewart designed and conducted this survey in accordance with well-established 

principles of survey research offered in litigation, as articulated in the Manual for Complex 

Litigation. (RPFF ¶ 1289). To that end, the survey defined the relevant population as men and 

women over the age of 18 in the United States who reported that they had personally purchased a 

product in the past month that came in a plastic container or was made of plastic. (RX 856 at 17; 

RPFF ¶ 1243, 1292). From this sample, respondents were disqualified if they stated in response 

to screening questions that they did not have a general understanding of what the term 

“biodegradable” means. (RPFF ¶ 1209; RX 856 at 17). The actual sampling frame was 

constructed from a random digit dialing sample obtained from Scientific Telephone Sampling 

and an age enhanced list was obtained from Survey Sampling, Inc. (RPFF ¶¶ 1236–37; RX 856 

at 17). Both of those companies are highly respected, well-known providers of samples for use 

in survey research. (RPFF ¶ 1242; RX 856 at 17).

Dr. Stewart determined that a sample size of 400 respondents was the sufficient amount 

of participants because that sample size provides, in the worst case, approximately plus or minus 

5% of the true population statistics 95% of the time. (RPFF ¶¶ 1231–33; RX 856 at 18). The 

respondents’ answers were accurately reported by well-trained interviewers who had been 

specifically trained in interviewing methodology, were under the supervision of highly qualified 

and experienced research supervisors, had been debriefed on the specific requirements and 

protocol for this survey, and had completed at least one practice interview. (RPFF ¶¶ 1260–63). 

Importantly, the interviewers were also randomly monitored by supervisors to assure that the 

interviews were conducted in the prescribed manner. (RPFF ¶¶ 1261–63). These interviewers 

and their supervisors were blind in the sense that they did not know for whom the survey was 

being conducted. (RPFF ¶¶ 1251–59). 
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Once the respondents were appropriately selected from a list of telephone numbers based 

on an algorithm employed by the Computer-Assisted Telephone Interviewing (CATI) system, 

interviewers clarified to potential respondents that the call was for research purposes and not 

telemarketing. (RPFF ¶¶ 1290–91). The interviewers and respondents then went through both 

parts of the survey. The first part contained screening questions, a “screener” in the survey 

vernacular (RPFF ¶¶ 1291–1292), and the second part was the main questionnaire. The screener 

was used to determine whether the respondent met the screening criteria and was a member of 

the relevant population. (RPFF ¶¶ 1269–70, 1279, 1292). Those questions ensured that the 

respondent was over 18, was age and gender representative within the sample, avoided those 

who work for a manufacturer of plastic products or a waste disposal organization, (RPFF ¶ 

1292),18 ensured that respondents had purchased a product in a plastic container or containing 

plastic within the past month, and ensured that respondents had a general understanding of the 

term biodegradable. (RPFF 1196, 1292–94). 

Respondents who qualified in the survey sample based on the screen questions were 

asked a series of substantive questions in the main questionnaire. (RPFF ¶ 1202). All but two of 

the questions in the main questionnaire were open-ended questions, which have the advantage of 

allowing respondents to offer answers that are qualified, provide context, or are otherwise 

nuanced, and which are useful for clarifying terminology by gauging the meanings of words and 

for informing variability among respondents. (RPFF ¶ 1293). 

The questions in the main questionnaire were clear and not leading. (RPFF ¶ 1278). The 

first few questions asked respondents about their perceptions of biodegradability generally. 

                                                             18 This exclusion was justifiable on the ground that these respondents would have 

atypical knowledge of the issues, and therefore would not be representative of the larger 

population. (RX 856 at 19–20). 
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(RPFF ¶ 1294). For example, Q4 asked, “If something is biodegradable, how long do you it 

would take for it to decompose or decay?” (RPFF ¶ 1295). The next set of questions asked the 

respondents to indicate in their own words what claims adapted from claims used by ECM mean 

to them. (RPFF ¶ 1295). 

The survey was conducted by qualified persons following proper procedures. Dr. Stewart 

himself personally designed the survey. (RPFF ¶ 1320). A well-known survey research agency, 

California Survey Research Services (CSRS), coordinated interviewing and data tabulation. 

(RPFF ¶ 1325). The field work for the survey cost $37,500. (RPFF ¶ 1297). In addition, the 

survey was pre-tested by conducting a small pilot project, which confirmed that no changes to 

the survey design were necessary. (RPFF ¶ 1298). The coding of the responses to the openended questions was carried out by experienced staff members at CSRS who were doubleblinded, and the codebook used was suggested by CSRS and approved by Dr. Stewart. (RPFF ¶¶ 

1257–59, 1299). The coders themselves were blind to both the sponsor and the purpose of the 

survey (i.e., they were double blinded). (RPFF ¶¶ 1253–59). All verbatim responses were coded 

independently by two coders and any disagreements were resolved in discussion. (RPFF ¶ 

1257). 

b. Dr. Stewart’s Survey Confirms that Not Even a Significant 

Minority of End-Use Consumers or ECM Customers Have a Single 

Definition of Biodegradation or Expectation as to the Rate at 

Which ECM Plastics Will Biodegrade 

Dr. Stewart’s survey first concluded that while consumers do have a conceptual 

understanding of what biodegradability is, that understanding is not material to any significant 

minority of consumers. (RPFF ¶¶ 1314–22). The survey also concluded that 68% of the 

respondents recognize differences in the rate of decomposition depending on the type of material 
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or the context. (RPFF ¶ 1332). The results also made very clear that the vast majority of 

consumers have an understanding that the process of biodegradability is highly varied and that it 

is not often a rapid process. (RPFF ¶ 1333). Furthermore, 98% of respondents believe that 

different types of products take different amounts of time to biodegrade, decompose, or decay. 

(RPFF ¶¶ 1308, 1311, 1322). Such differences, according to the respondents, include the type or 

size of the material, the context, or the environment. (RPFF ¶¶ 1308, 1311, 1322). Dr. Stewart 

concluded that consumers recognize significant time variances in decomposition, and that there 

is insufficient evidence to conclude that their understanding of the term biodegradability is 

restricted to decomposition processes that occur within one year or less. (RPFF ¶¶ 1300–22). 

As for the questions which incorporated ECM’s claims made to industrial purchasers, Dr. 

Stewart found that a common response included a lack of understanding, expressions of 

confusion, expressions of skepticism or disbelief, or a simple restatement of the claim. (RPFF ¶ 

1337). That lack of understanding, confusion, and skepticism make it highly unlikely that these 

claims would be material to an end use consumer, even if the claims were directed right at the 

end use consumer. (RPFF ¶ 1338). In sum, Dr. Stewart’s survey clarified that two of three 

criteria required for a finding of deception, a false belief attributable to actions of the marketer 

and that the claim be material to consumers, are not present in ECM’s alleged advertising. 

(RPFF ¶ 1339). 

Dr. Stewart also conducted a limited Manufacturers Pilot Survey in an attempt to 

ascertain whether more knowledgeable purchasers have a more common understanding of 

biodegradability. (RPFF ¶ 1340–41). To that end, ECM provided Dr. Stewart a list of 

representatives from customer organizations that were involved in the purchase of materials for 

the manufacturer of plastics. See John Crane Prod. Solutions, Inc. v. R2R and D, LLC, 861 F. 
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Supp. 2d 792, 799 (N.D. Tex. 2012) (citations omitted) (explaining that even if “a company’s 

engineers may be distinct from the employees who purchased the [product] . . . [s]uch business 

transactions are at least as complex as transactions that other courts have classified as 

sophisticated”); (RPFF ¶ 1341). 

Representatives from 10 of ECM’s customers participated in this survey, which was also 

carried out by CSRS. (RPFF ¶ 1342). Like the consumer survey, this survey concluded that 

even among more knowledgeable and sophisticated customers there is substantial variation in 

opinions about how quickly a biodegradable product should take to decompose. (RPFF ¶ 1342). 

Dr. Stewart stopped conducting this survey after receiving only ten responses because Dr. 

Stewart believed he would run out of time before he could complete the survey and obtain any 

meaningful results. (RPFF ¶ 1344). 

c. Complaint Counsel’s Survey Expert Relies on an Incompetent 

Google Survey to “Correct” Incompetent Synovate and APCO 

Surveys 

In support of the One Year Rule, the Commission relies on a survey conducted by APCO 

Insight, and dismisses a survey conducted by Synovate. (RX 195 at 121). According to the 

Commission, the APCO survey concluded that 60% of respondents expect that an item marketed 

as degradable will fully decompose in one year or less. The problem with the Commission’s 

reliance on the APCO study is that the APCO study is rife with flaws, as acknowledged by both 

Dr. Stewart and Complaint Counsel’s own expert, Dr. Shane Frederick. (RPFF ¶¶ 818–77). For 

example, the APCO study uses close-ended questions, which are unhelpful and misleading, as 

here when there are many possible answers among respondents.19 Importantly, when beginning 

                                                             19 RPFF ¶ 846; RX 856, at 7; RX 858 (Frederick, Dep. at 165). 
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consumer perception work in a new area, open-ended questions are an essential tool. (RPFF ¶¶ 

848–49). 

One of the critical limitations of close-ended questions is particularly important where, as 

here, the FTC is trying to pigeon hole a consumers’ perception of the term “biodegradability” 

into one uniform definition. Close-ended questions inherently suggest greater homogeneity 

within a sample of respondents than may actually exist because closed ended questions exist in a 

universe with only four or five possible response. (RPFF ¶¶ 859–865). Self-evident is the fact 

that even where there is maximum disagreement, 20% of respondents will nevertheless appear to 

agree on an answer to a question in which there are only five possible answers. (RPFF ¶¶ 860–

63). This fact makes the FTC’s “significant minority” argument problematic when they 

conclude that a significant minority of consumers believe something, when that alleged uniform 

belief is based upon a question that, if people answered wholly randomly, would be expected to 

yield 20% agreement on any one of the possible five answers. (RPFF ¶¶ 869–872). 

Dr. Stewart explains that an example of misleading homogeneity is found in the APCO 

survey question regarding how long it should take for something to decompose if it is labeled 

biodegradable. (RPFF ¶¶ 869–72). In that question, four of the six response options are a year 

or less, so it is not surprising that 60% of respondents chose an option of one year or less. 

Indeed, random responses spread among the six options would result in 66% of the responses 

falling in one of the four categories related to one year or less. (RPFF ¶¶ 869–72). That is what 

one must expect when people are asked a question about which they have little knowledge—a 

near perfect proportion of random responses. 

Well aware of the problems in the APCO survey, Complaint Counsel engaged the 

services of Dr. Shane Frederick in an attempt to support the One Year Rule. (RPFF ¶¶ 275–77). 
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Dr. Frederick, who, like Dr. Stewart, proclaims that open-ended questions are superior to closedended questions, performed his own “survey” using largely open-ended questions. (RPF ¶¶ 277–

80). The problem for Complaint Counsel, however, is that unlike Dr. Stewart’s survey, Dr. 

Frederick’s survey still endeavored to pigeonhole responses into numerical categories after the 

fact and does not meet generally accepted standards for survey research. (RPFF ¶¶ 904–1104; 

RX 56 at 10). In fact, Dr. Frederick readily admits that he is not familiar with the standards that 

are used to determine the qualifications of survey experts in federal court or in proceedings 

before the FTC. (RPFF ¶¶ 878–84). Dr. Frederick is unfamiliar with the Reference Manual on 

Scientific Evidence, and has no “specific criterion in mind” as to what makes a survey valid. 

(RX 858 (Frederick, Dep. at 186)). In fact, Dr. Frederick does not “know what other people have 

written” regarding what constitutes acceptable survey principles that define a valid survey. (RX 

585 (Frederick, Dep. at 186–187)). Complaint Counsel drafted substantial portions of Dr. 

Frederick’s expert report, including citations and substantive content. (RPFF ¶¶ 885–94). 

Perhaps Dr. Frederick’s documented lack of knowledge about what constitutes valid 

surveys in the litigation context is the reason why he chose to conduct a Google Consumer 

Survey with no screening questions and with only one question per respondent in an attempt to 

support the One Year Rule.20 He chose the Google Survey interface despite the fact that no 

Google Consumer Survey has ever been relied upon as evidence in an FTC proceeding, and that 

its use has never been approved of or validated in any peer reviewed literature. (RX 858 

(Frederick, Dep. at 189); RPFF ¶ 903). Google Consumer Survey is simply unproven at best. 

                                                             20 Cost was also another factor. (RX 858 (Frederick, Dep. at 123–5)). This must be 

especially true because the FTC paid Dr. Frederick a flat fee of $40,000, of which Dr. Frederick 

was entitled to keep whatever amount he did not spend. (RX 858 (Frederick, Dep. at 8:11–15)). 

Of the $40k allocated to Dr. Frederick, he profited approximately $32,010, mostly by choosing 

cheap survey methodologies. (RPFF ¶¶ 899–904). 
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As Dr. Frederick recognizes, there are well constructed consumer internet panels available, that, 

for example, Dr. Stewart often uses. (RPFF ¶¶ 896–98). The reasons for the lack of support for 

Dr. Frederick’s Google Consumer Surveys are obvious. (RPFF ¶¶ 915–1104). For one, there is 

no way to ascertain the degree to which the sample of respondents used in Dr. Frederick’s 

Google Consumer Surveys are representative of any identifiable population. (RPFF ¶¶ 922, 

1090). The sample itself is unknown and unknowable. That is because there is no verification of 

respondents with Dr. Frederick’s Google Consumer Surveys; rather, information on respondents 

to Dr. Frederick’s Google Consumer Surveys is merely inferred by Google from information 

associated with or that resides on a computer. (RPFF ¶ 1090). Dr. Frederick used no screener 

questions to assure that he knew who in fact was responding to any particular question and what 

the age was of the respondent. (RPFF ¶ 1092). He declined to pay the additional fee to include 

two-part questions that might have provided more direct information about the respondent 

population. (RPFF ¶ 1091). 

Google survey generally works by giving internet users access to “premium content” in 

exchange for answering a question, as opposed to paying for a subscription. Therefore, the 

questions in Dr. Frederick’s survey were, at best, a distraction and barrier to respondents whose 

objective it is to access information, not complete a survey. (RPFF ¶ 1095). That type of 

questioning creates a disinterest bias; a concept alien to Dr. Frederick at the time of his 

deposition. (RPFF ¶¶ 1095–96). That explains why so many respondents answered Dr. 

Frederick’s survey with nonsensical answers. (RPFF ¶ 1096). 

In addition, Dr. Frederick, and his students who acted as his coders, failed to accurately 

report the data received from the Google Survey. (RPFF ¶¶ 1097–1104). For example, Dr. 

Frederick coded nonsensical answers such as “1 second” as “less than one year.” (RPFF ¶¶ 
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1041–44). That may be because, unlike Dr. Stewart’s survey which used well-trained coders, 

Dr. Frederick believes that coders only need to be able to read and follow directions.21 

Moreover, Dr. Frederick’s survey failed to code accurate and relevant responses such as “don’t 

know.” (RPFF ¶¶ 1099–1100). Even more troublesome, however, is the fact that Dr. 

Frederick’s supervising coder, Andrew Meyer, was aware that Dr. Frederick’s research was 

going to be used by Complaint Counsel against ECM. (RPFF ¶ 1101). Dr. Frederick was 

likewise aware and yet he did most of the coding work. (RPFF ¶¶ 1034–1104). In short, the 

coders were not blinded, so bias infected the study. (RPFF ¶¶ 1034–1104). 

In addition, as Dr. Stewart makes clear, even if Dr. Frederick’s survey was valid—it is 

not—its results, like Dr. Stewart’s survey results, suggest that there is considerable diversity 

among respondents in terms of their claimed knowledge about biodegradable products and their 

views about the time it takes various materials to biodegrade. (RX 856 at 13–14). Therefore, 

because Dr. Frederick’s “survey” is plainly not valid as judged against generally accepted survey 

principles, and because its results do not show any uniform understanding amongst consumers 

about how long a biodegrade product takes to decompose, the concerns that both he and Dr. 

Stewart have regarding the APCO study cannot be alleviated by the existence of Dr. Frederick’s 

“survey.” (RPFF ¶¶ 878–1104; RX 858 (Frederick, Dep. at 151–52). 

Dr. Stewart explained in detail that Dr. Frederick’s Google Consumer Surveys failed to 

satisfy all seven of the generally accepted principles of survey research. In particular, Dr. 

Stewart found: (1) the survey did not properly choose and define a population because it was not 

clear what the population was (RPFF ¶ 918); (2) the sample population was not representative of 

                                                             21 See RX 858 (Frederick, Dep. at 168–169). Based on some of the initial coding 

disclosed to ECM by Dr. Frederick, it appears that Dr. Frederick’s coders were even unable to 

read and follow directions correctly. (RX 856 at 13). 
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the population, or could not be determined to be representative (RPFF ¶¶ 918–923); (3) Dr. 

Frederick did not accurately report the data gathered (RPFF ¶¶ 923–26); (4) the data was not 

analyzed in accordance with accepted statistical principles (RPFF ¶¶ 927–32); (5) the questions 

that were asked were not clear (RPFF ¶¶ 933–35); (6) the survey was not conducted by unbiased 

qualified persons (RPFF ¶¶ 936–56); and (7) the process was not conducted to ensure objectivity 

(RPFF ¶¶ 936–64). 

2. ECM Permanently Discontinued the “9 Month to 5 Year” Claim Three 

Years Ago and, So, It Is Not a Basis for Equitable Relief 

Complaint Counsel bases this case on the mistaken assumption that it is a typical 

deceptive advertising case, but the record reveals this case to be sui generis. In nearly every 

deceptive advertising case brought before the agency save this one, advertising22 involves paid 

solicitations of business to an audience of lay consumers who then purchase the product in issue 

without substantive investigation of its composition and utility. In stark contrast here, there is no 

advertising material to a purchase within the legal definition of the term.23 (RPFF ¶¶ 300–303). 

Most companies hear of ECM by word of mouth from other companies or at networking 

functions. (RPFF ¶ 304). The customers are not lay consumers but sophisticated plastics 

manufacturers possessed of their own scientists, engineers, lawyers, and marketing departments. 

(RPFF ¶¶ 415–418; 433–604). Purchases are not made based on ECM’s web site, ECM 

                                                             22 “Advertising” is defined by the FTC “to mean a notice or announcement that is 

publicly published and is paid-for.” In the Matter of R.J. Reynolds Co., Inc., FTC Dkt. No. 9206, 

1988 WL 490114, at *2 (Mar. 4 1988); see also First Health Grp. Corp. v. BCE Emergis Corp., 

269 F.3d 800, 803–04 (7th Cir. 2001) (explaining that “advertising is a form of promotion to 

anonymous recipients, as distinguished from face-to-face communication. In normal usage, an 

advertisement read by millions (or even thousands in a trade magazine) is advertising, while a 

person-to-person pitch by an account executive is not”). 

23 Indeed, ECM spends less than $12,000 per year on advertising, mainly for the 

maintenance of its web site. (RPFP ¶ 300). 
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information disseminated, or even ECM discussions but only after a six month to multi-year 

process of evaluation in which the company investigating the product actually manufactures a 

test batch of the plastic with the ECM additive infused, testing it to determine its utility for itself. 

(RPFF ¶¶ 296, 307). That process is not optional for ECM’s plastic manufacturer customers, but 

a necessity because without actually manufacturing the company’s own plastic with the additive 

included they cannot know whether the resulting plastic will be capable of mass production using 

the company’s existing equipment, will be affordably produced, will result in a product that has 

the same functionality as the existing product, and will meet consumer expectations for the 

product. (RPFF ¶¶ 355, 401, 404).24 Thus, we here deal principally not with commercial 

speech, but with fully protected non-commercial information exchange that is open (ECM 

encourages customers to test its additive in their plastic) between sophisticated parties, based on 

the customers’ own evaluative testing, which forms the actual basis for each purchase, wherein 

the truths of utility and functionality are discerned through independent customer ascertainment. 

The web site is of no utility to lay consumers because the additive is a pellet unusable 

except by plastics manufacturers; interest, if at all, from an individual not within a plastics 

company, is thus academic. (RPFF ¶ 298). 

Over the past decade, the information ECM has exchanged with its prospective and actual 

customers has necessarily changed to accommodate an evolution of scientific understanding 

concerning how its additive technology works in landfill environments. In the first instance, 

ECM offered its “9 month to 5 year” degradable claim not as a performance claim, but as a 

means to distinguish its technology from competing technologies claiming to satisfy the short-

                                                             24 RX 875, at 258 (the “vast majority” of ECM’s customer “are very large and 

sophisticated companies”). 
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term compostability standards,25 a claim reasonably based on testing performed by the additive’s 

inventor, Patrick Riley, (RPFF ¶¶ 43–48, 51), and by ECM’s current President Robert Sinclair. 

(RPFF ¶¶ 51–54). Later, the FTC revised its Green Guides to recommend qualifications. (RPFF 

¶ 313).26 ECM has always qualified its marketed claims27 and has explained to customers that 

the time frame for biodegradation is entirely dependent on a multiplicity of environmental 

factors. (RPFF ¶¶ 310–12).28 ECM updated its website to include the following explanation: 

The basic concept is that biodegradation is a natural process that occurs 

around the world but at various speeds due to various conditions. Plastics with 

our additives behave like sticks, branches or trunks of trees. Due to this fact, 

we do not guarantee any particular time because the time depends on the same 

factors that the biodegradation of woods and most other organic materials on 

earth depend – ambient biota and other environmental conditions. Under 

specific composting conditions with additional accelerants sprayed on them, 

some customers have reported biodegradation in as little as a couple of 

months. Under the more usual, commercial composting conditions using high 

heat processes, a time frame of around some period greater than a year is a 

reasonable expectation.29

(RPFF ¶ 377). That type of information is characteristic of ECM’s communications 

with all of its customers. (RPFF ¶¶ 378).30 

 Troubled with the concept that the FTC would require a specific rate of biodegradation 

(an impossible task given real world environmental variances), ECM has used disclaimer 

language that is consistent with the scientific evidence, conveying to every customer that, for 

each individual piece of plastic produced, the rate of biodegradation will vary, most often using 

                                                             25 RX 875 (Sinclair, Dep. at 274) (the 9 month to 5 year claim is intended “to distinguish 

[ECM] from shorter biodegradable alternatives—in other words, the composters”). 

26 RX 173. 

27 RX 875 (Sinclair, Dep. at 277) (ECM “always qualified the claims”). 

28 See, e.g., RX 135. 

29 RX 681, at 61. 

30 See id. (“It is not a ‘poof, it’s gone’ system but simply makes the plastic product 

biodegrade as if it were a stick or a branch off a tree rather than ‘sticking around’ for hundreds of 

years”). 
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the example that a piece of plastic that ultimately ends up in a landfill in a frigid and dry climate 

will biodegrade at a much different rate than that ending up in a warm and moist climate. (RPFF 

¶ 311). The evidence suggests that ECM customers are, in fact, only concerned with marketing a 

“biodegradable” plastic and, so, they did not base a purchase decision on rate of biodegradation 

at all (and considered ECM’s statements concerning the “rate” of biodegradation only to the 

extent those claims were apparently mandated by the Federal Trade Commission).31 We note 

further, that ECM’s plastic manufacturing clients are veterans in the plastics business, very 

familiar with their products’ functionality and disposition in the market and with the wide variety 

of competing biodegradable and compostable products in the market. (RPFF ¶¶ 433–604). They 

are the most well-informed as to biodegradation of their own products because they have to 

know whether their products will meet functional and environmental expectations. (RPFF ¶¶ 

398–400). 

 Following the revisions to the Green Guides, ECM dispatched a truthful and nonmisleading email to all of its customers explaining the FTC’s requirements concerning 

biodegradable claims.32 This e-mail, in response to the Green Guide revisions, explained: 

If you have evidence that your products with our additives will fully 

biodegrade in one year or less in the environment where it will be customarily 

disposed you may still make an unqualified claim of “biodegradable” for 

those products. But for most of our customers’ plastic products with our 

additives whose customary disposal is in a landfill, they will not be able to use 

that unqualified claim.33

ECM continued by discussing the benefits of its product: “Municipal Solid Waste that 

biodegrades slowly but surely over periods from a few years to tens of years provides the 

                                                             31 See RX 87 (Blood, Dep. at 193). 

32 See, e.g., RX 35–RX 77. 

33 See RX 35–RX 77. 
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(sic) [landfill gases] that is captured, processed and sold to the public renewable energy or even 

new chemical source. This is the end-of-life scenario that has made plastic products with our 

additives so ever-increasingly popular.”34 

Sophisticated ECM customers have understood that each product is unique, and 

biodegradation testing is likely required to assess how each specific product performs. 

The evidence reveals that ECM has truthfully and accurately informed customers that the 

rate of degradation in the environment is highly variable and uncertain, and dependent on many 

factors. (RFPP ¶¶ 310, 311, 377, 421). ECM’s customers were aware of the FTC’s requirements 

in the Green Guides, and they tailored their advertising content according to those policies. (RX 

35–RX 77; RX 871 (Blood, Dep. at 193)). 

ECM always explained the actual rate of biodegradation for each specific plastic to 

customers as being an approximation that was, of course, subject to numerous disposal 

conditions. (RPFF ¶ 310). ECM explained to customers that it had seen products biodegrade in 

less than nine months in some conditions, however, conditions in an extremely dry or cold 

climate might result in biodegradation in far more than five years. (RPFF ¶ 311). 

The time frame was always expressed as possible but not probable with the probability being 

dependent on actual conditions of the location where the plastic would ultimately be discarded. 

(RPFF ¶ 312). The FTC revised its Green Guides to prohibit unqualified biodegradable claims 

without suitable qualifications in 2012. (RPFF ¶ 313). 

ECM stopped using the nine months to five year time frame approximately three years 

ago after the revision of the Green Guides was released. (RPFF ¶ 314). Mr. Sinclair felt that the 

literal interpretation of ECM’s timeframe claims was more of an obstacle than a benefit, and 

                                                             34 RX 35–RX 77 (emphasis added) (collection of the same notice email send to customers 

after Green Guide Revisions). 
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ECM discontinued making such claims. (RPFF ¶ 315). Once the most recent revision of the 

Green Guides required a product to fully biodegrade within one year to make an unqualified 

“biodegradable” claim, ECM determined that it had to qualify its claim to satisfy the FTC 

regulation. (RPFF ¶ 316). 

From that point on, ECM has stated that its plastics infused with the ECM additive would 

biodegrade in some timeframe greater than one year. (RPFF ¶ 317). ECM has no intention of 

ever making the nine month to five year claim again. (RPFF ¶ 318). As explained above, it is 

clear from the record evidence that ECM customers did not consider material to their purchase 

any claim of rate but, instead, depended on the general claim of biodegradability, which is borne 

out by those company’s own tests, 33 of which are in the record and show the additive hastening 

biodegradation of the plastic itself. (RPFF ¶¶ 357–59, 431, 605–725; infra at 117). 

3. Complaint Counsel’s Straw Man Definition of “Biodegradable” is 

Unsupported by Science, and Arbitrary and Capricious 

A court should “hold unlawful and set aside agency action, findings, and conclusions 

found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with 

law.” 5 U.S.C. § 706. An agency's decision is arbitrary and capricious when the agency “entirely 

failed to consider an important aspect of the problem, offered an explanation for its decision that 

runs counter to the evidence before the agency, or is so implausible that it could not be ascribed 

to a difference in view or the product of agency expertise.” Motor Vehicle Manufacturers Assoc. 

v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29 (1983). 

Review of agency action is “not merely perfunctory,” the review should be a ‘searching 

and careful’ inquiry.’” Int’l Ladies' Garment Workers' Union v. Donovan, 722 F.2d 795 (D.C. 

Cir. 1983); Specialty Equip. Mkt. Ass’n v. Ruckelshaus, 720 F.2d 124, 132 (D.C. Cir. 1983) 
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(“when reviewing agency's determinations under "arbitrary and capricious" standard, "we must 

make a substantial and searching inquiry to ensure that the agency's decisions are the product of 

reasoned thought and based upon a consideration of relevant factors”); Dickinson v. Zurko, 527 

U.S. 150, 155 (1999) (“[t]he APA requires meaningful review; and its enactment meant stricter 

judicial review of agency fact finding than Congress believed some courts had previously 

conducted”). 

Complaint Counsel’s action against ECM is predicated on an arbitrary and capricious 

definition of “biodegradation” that results in a bias that favors rapidly degrading over more 

slowly degrading substances. Compare 16 C.F.R. § 260.7(b) (allowing “compostable” claims if 

the marketer has “competent and reliable scientific evidence that all the materials in the item will 

break down into, or otherwise become part of usable compost in a safe and timely manner in an 

appropriate composting facility, or in a home compost pile or device”) with 16 C.F.R. § 260.8(c) 

(prohibiting “biodegradable” claims “if the items do not completely decompose within one year

after customary disposal”) (emphasis added). That definition does not arise from science, (RPFF 

¶¶ 774–814), but is a policy choice, one that affects basic environmental policy nationally and, as 

explained below, although it is sought by Complaint Counsel to be a rule of decision in this case, 

cannot be because it is beyond the jurisdiction of the FTC, it being a regulatory province 

squarely within the enabling statutory powers of the EPA, not the FTC, to decide. See infra at 

202 (Ultra Vires agency action). 

In their Proposed Order, Complaint Counsel specifically explained that “[f]or unqualified 

biodegradability claims, any scientific technical protocol (or combination of protocols) 

substantiating such claims must assure complete decomposition within one year and replicate, 

i.e., simulate, the physical conditions found in landfills, where most trash is disposed.” See
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Complaint, at 12 (¶4). In other words, for a product to be considered “biodegradable,” the 

product must fully biodegrade within one year. Adoption of this One Year Rule is arbitrary (all 

manner of commonly recognized “biodegradable” substances, such as banana peels, orange 

peels, tree trunks, and paper, do not reliably break down into elements in nature within one year 

after customary disposal); adoption of the One Year Rule is capricious (it deviates from the peer 

reviewed scientific literature on “biodegradation” which in not a single instance of record 

includes the definition of biodegradation presented by Complaint Counsel); adoption of the One 

Year Rule is an abuse of agency discretion (it is not for the FTC, but for the EPA, to determine 

standards of biodegradability in relationship to landfills and by proscribing use of this essential 

term in identifying products of import for landfill disposal, the agency interferes, wittingly or 

not, with national environmental policy). (RPFF ¶¶ 774–814, 1522, 1523, 1538, 1895). 

Complaint Counsel therefore creates out of whole cloth a “definition” of biodegradability 

for purposes of unqualified claims that is alien to the common definition of the term in the 

dictionary and to the scientific definition of the term in the peer reviewed literature, and 

compounds the error by failing to acknowledge that in the real world there is literally no product 

or substance commonly recognized as biodegradable that can reliably satisfy the definition: not 

a banana peel, not an orange peel, not a tree trunk, not paper, and certainly not a common plastic 

polymer. 

a. The Scientific Definition of Biodegradation Conflicts with 

Complaint Counsel’s Definition 

The scientific experts in this case testified that many scientifically accurate definitions 

exist for terms like “biodegradable,” “biodegrade,” and “biodegradation.” (RPFF ¶¶ 782–95, 

797–805). The definitions for those terms are necessarily broad to accommodate a range of 
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potential mechanisms. For example, the Merriam-Webster dictionary defines “biodegradable” as 

something “capable of being slowly destroyed and broken down into very small parts by natural 

processes, bacteria, etc.” or “capable of being broken down especially into innocuous products 

by the action of living things (as microorganisms).” (RPFF ¶ 780).35 Other sources have defined 

“biodegradable” to mean “capable of being decomposed by bacteria or other biological means.” 

(RPFF ¶ 781).36 The definitions universally describe a biological process of breakdown and 

equally universally do not include either a time limit on the process or a specified degree of 

disintegration or elimination of the degrading product. (RPFF ¶¶ 774–81). 

ECM’s experts have testified that “biodegradation” is properly described as an ongoing

process, and the word “biodegradable” refers, simply, to a material capable of undergoing that 

process. (RPFF ¶¶ 791, 793, 794, 798–800). Noticeably absent from scientific definitions of 

“biodegradation” or “biodegradable” is any reference to a specified rate, extent, or time period 

for degradation. (RPFF ¶¶ 798–800). Outside of this case, Complaint Counsel’s experts have 

never used time or rate limitations in their published definitions of “biodegradation.” (RPFF ¶¶ 

806–07). It is a contrived distinction, an artificial construct divorced from the real world. It is a 

superimposed policy judgment, not a reflection of accepted meaning known to consumers or to 

ECM customers. 

As understood in science, the term “biodegradation” refers to the process by which 

microorganisms, bacteria, fungi, etc., combined with their natural mechanisms of action, effect 

the breakage of plastic bonds through acids and enzymatic action. (RPFF ¶¶ 774–82, 790, 794). 

                                                             35 See "Biodegradable." Merriam-Webster.com. Merriam-Webster, n.d. Web. 22 July 

2014, available at http://www.merriam-webster.com/dictionary/biodegradable. 

36 See “Biodegradable.” Collins English Dictionary, 10th Ed. 2009 (July 22, 2014), 

available at http://dictionary.reference.com/browse/biodegradation. 
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By contrast, Complaint Counsel’s experts were asked by Complaint Counsel to adopt a 

peculiar, artificial construct alien to the scientific literature for the definition of “biodegradable,” 

to wit: “that the entire plastic will completely break down and return to nature (i.e., decompose 

into elements found in nature) within one year after customary disposal (i.e., incinerator, landfill, 

or recycling).” (RPFF ¶ 771).37 Dr. McCarthy, Complaint Counsel’s expert, testified that he 

prepared his expert report as a “collaborative effort between [himself] and complaint counsel.” 

(RPFF ¶ 1360).38 He testified that the definition of “biodegradable” which included the one-year 

limitation “was the definition that [he] used with respect for this case” throughout his report and 

in his expert opinion.39 He admits that Complaint Counsel wrote that definition presented in 

footnote 1 of his expert report as: 

[B]iodegradable means that the entire treated plastic will completely break 

down and return to nature (i.e. decompose into elements found in nature) 

within one year after customary disposal (i.e. incinerator, landfill, or 

recycling). 

(RPFF ¶¶ 269–70). 

His contribution was the last sentence of the footnote, which presumptively equates 

without attribution this superimposed agency definition of the term with the scientific definition 

of the term. (RPFF ¶ 272). But during cross examination, Dr. McCarthy dissembled, admitting 

that he was entirely unaware of any instance in which a peer reviewed article concerning plastics 

biodegradation ever defined the term biodegradation as Complaint Counsel had. (RPFF ¶ 273). 

Indeed, Dr. Barlaz explained that the definition given by Complaint Counsel was nowhere 

present in the scientific literature. (RPFF ¶ 799). That understanding was mirrored by other 

experts who testified. (RPFF ¶¶ 798, 800). 

                                                             37 See RX 841 (McCarthy, Dep. at 20–21); CCX 891 (McCarthy’s Rep, at p. 5, n.1). 

38 RX 841 (McCarthy, Dep. at 20). 

39 RX 841 (McCarthy, Dep. at 21).
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 The inherent absurdity of the definition came to the fore repeatedly throughout the 

hearing, as it had in Dr. McCarthy’s deposition. (RPFF ¶¶ 1365–73, 1536–38). Asked whether a 

product could be considered “biodegradable” if it degraded 95 percent in 364 days, Dr. 

McCarthy testified that it “would not satisfy the definition.” (RPFF ¶ 1392).40 He maintained 

that position even though all other qualified experts in this case have accepted that a product will 

almost never biodegrade to one hundred percent, as most substances will leave behind some 

residue or humus. Dr. McCarthy’s strained attempt to defend Complaint Counsel’s erroneous 

definition of “biodegradable” continued: 

Q: Assuming that on day 365 [a product] was only 95 percent 

[biodegraded] still, but on day 366 it becomes 100 percent, would that 

satisfy the definition of biodegradable in [McCarthy’s report]? 

A: That wouldn’t satisfy the definition.41

(RPFF ¶ 1392). 

Consider the implications, from a scientific perspective, of an FTC policy that limits the 

definition of “biodegradability” in that manner, excluding products that are obviously—and 

scientifically proven to be—“biodegradable” simply because the achievement cannot be 

documented within an arbitrarily one year time limit. 

 Perhaps most troubling is that no scientific article supports Dr. McCarthy’s definition of 

biodegradable. Complaint Counsel’s purported expert in landfills explained that even “rapidly 

degrading wastes” such as food waste and sewage sludge might take between 9 and 14 years to 

biodegrade fully.42 Moreover, Dr. McCarthy himself has labeled “biodegradable” plastic 

polymers that he did not prove through testing would reliably biodegrade 100% within one year. 

                                                             40 RX 841 (McCarthy, Dep. at 28). 

41 RX 841 (McCarthy, Dep. at 29). 

42 Tolaymat, Tr. 153–54. 
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(RPFF ¶¶ 1451–64).43 Indeed, under a sworn affidavit to the United States Patent and 

Trademark Office, Dr. McCarthy affirmed the validity of scientific evidence supporting as 

“biodegradable” a plastic polymer resin that by testing of only 45 days biodegraded by only 

14%, Dr. McCarthy’s ‘199 patent. (RPFF ¶¶ 1454, 1458, 1463, 1465, 1467, 1542). 

 Complaint Counsel’s definition of “biodegradable” entraps every business in this field 

that it cares to charge, regardless of the scientific merits. The definition cannot be reliably 

satisfied by any company in the plastics biodegradation business and, so, any company charged 

will necessarily fail the arbitrary One Year Rule. Complaint Counsel’s approach therefore 

becomes one where no unqualified claim concerning “biodegradation” can ever exist in the 

market, even if the products are, in fact, “biodegradable.” Simply put, no company can establish 

a “rate” or “extent” of biodegradation because the environmental factors existing in MSW 

landfills are highly variable and uncertain, thus causing the One Year Rule to form a de facto 

absolute barrier to any biodegradation claim for products destined for disposal in landfills. 

(RPFF ¶¶ 1582, 1640–43, 1713, 1723, 1815, 1851, 1871–76). Significantly, Complaint Counsel 

put forth no evidence of any kind showing how a company in ECM’s position should have, or 

even could have, established scientifically a set rate and extent of biodegradation in an MSW 

landfill. Just like a piece of paper, which may degrade rapidly or not at all—depending on 

environmental conditions—the concept of biodegradability is an intrinsic property of the 

material and not a process quantifiable by an arbitrary time limit of one year. (RPFF ¶¶ 65, 

1893). Living things, microbes have their own predispositions to metabolize carbon chains and 

those predispositions are affected by many variables but one that certainly does not affect their 

actions is an FTC time clock. 

                                                             43 RX 362; RX 755, at 13. 
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Because plastics manufactured with ECM’s additive satisfy the generally accepted 

scientific definitions of “biodegradable,” and because there is no competent survey evidence to 

establish that a significant minority of ECM customers or lay consumers share a common 

understanding of the term or a set time period within which they expect 100% biodegradation of 

plastics to occur, the evidence does not support a conclusion of deception. The use of the claim 

“biodegradable” in marketing is, at worst, potentially misleading commercial speech for which 

the constitutional resort remains imposition of a reasonable and succinct claim qualification 

(such as, the actual rate of biodegradation depends on numerous environmental variables which 

may or may not be present in any given disposal location), not cease and desist orders that 

arbitrarily limit the right to communicate the term biodegradation because a set rate is not 

provided (which would be impossible to prove and misleading in every case) or because a set 

degree of decomposition is not provided (which would also be impossible to prove and 

misleading in every case). 

b. The Anti-Competitive Effect of Enforcement of Complaint 

Counsel’s Biodegradation Definition 

Complaint Counsel’s arbitrary and capricious definition of “biodegradable” substantially 

assures the defeat of competitive markets in biodegradable plastics by erecting an impenetrable 

barrier to use of the term “biodegradable” in those markets for all products except compostable 

bioplastics. In the case of compostables, the FTC has adopted a lenient definition that sets no 

time limit for the process of degradation and no complete requirement of elimination or 

dissolution of the compostable product. See 16 C.F.R. § 260.7 (allowing marketers to market 

their products as compostable if the marketer has “competent and reliable scientific evidence that 

all the materials in the item will break down into, or otherwise become part of usable compost in 
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a safe and timely manner in an appropriate composting facility, or in a home compost pile or 

device”). 

Private interest groups heavily lobbied the FTC to enact more demanding regulations for 

biodegradable plastics than for compostables, succeeding in that endeavor in the 2012 

amendments to the Green Guides. (RPFF ¶¶ 1416–17). Among those groups were organizations 

like the Biodegradable Products Institute (BPI), which is a member-based organization 

representing compostable technologies,44 and Metabolix, Dr. McCarthy’s principal benefactor at 

UMass Lowell. (RPFF ¶¶ 1413–19). Indeed, both BPI and Metabolix also lobbied the FTC to 

take enforcement action against their competitor ECM. (RPFF ¶¶ 1413–18). 

“Biodegradable” plastics are not the same as “compostable” products. While a 

“compostable” product might also be considered part of the “biodegradable” universe, the 

opposite is not true because the process of composting involves different environmental elements 

than those present in landfill environments.45 Composting involves aerobic processes (with 

oxygen) as opposed to anaerobic processes common in landfills.46 Because composters, 

including commercial systems, are actively managed to promote optimal conditions, composting 

is expected to yield higher rates of degradation at a faster interval than biodegradation in 

anaerobic environments such as landfills. (RPFF ¶¶ 327, 1693). 

The ASTM has established testing protocols that assess the compostability of products 

including plastic polymers in the anaerobic environment. (RPFF ¶ 1426).47 Partly because 

compostable systems benefit from rapidly degrading waste, the standards concerning 

“compostability” are generally pass/fail, whereby a product must degrade past a certain extent 

                                                             44 See, e.g., RX 172. 

45 RX 875 (Sinclair, Tr. at 85). 

46 Id. 

47 See, e.g., RX 367. 
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within a specified period of time before the product can be called “compostable.”48 Ironically, 

the FTC rules are the opposite, setting no time limit or extent of degradation for compostable 

biodegradation and setting an arbitrary one year time limit and a complete biodegradation 

requirement for biodegradable plastics. Compare 16 C.F.R. § 260.7 with 16 C.F.R. § 260.8. 

The ASTM D6400 protocol is the “Standard Specification for Labeling of Plastics 

Designed to be Aerobically Composted in Municipal or Industrial Facilities.”49 That standard 

requires 60% biodegradation by biological processes during composting within 180 days.50 

Other similar standards (e.g., EN 13432) require 90% biodegradation in that time period.51 

Under the D6400 standard, a product that degrades only 59% in 180 days is not considered 

“compostable,” but a product that degrades 61% would be “compostable.”52 

Witnesses (fact and expert) testified in this case that the ASTM body is a political and 

scientific arena, where methods/standards are sometimes driven principally by financial 

interests.53 There are no membership requirements in the ASTM working groups that 

promulgate standards.54 Any company or individual with a vested interest, and financial support, 

can participate in the voting process that results in industry standards.55 Those standards have no 

legal precedence, and language in the standards that relates to legal standards can be ignored. 

The ASTM testing standards are relevant to the extent they embody methodologically sound 

methods to gather scientific data, which must then be interpreted. 

                                                             48 CCX 91. 

49 CCX 91. 

50 Id. 

51 See RX 772. 

52 CCX 91. 

53 Sinclair, Tr. 799–80; CCX 943 (Barlaz, Dep. at 95–98). 

54 CCX 943 (Barlaz, Dep. at 95–98). 

55 RX 875 (Sinclair, Dep. at 285). 
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Members of the compostable industry have heavily influenced the publication and 

revision of certain ASTM standards relating to plastics biodegradability testing.56 Tests like the 

D6400 are tailored to rapidly degrading products that can perform well enough within the narrow 

180 day testing period.57 Those tests, however, are inadequate to measure the long-term 

biodegradability of more slowly degrading products, like plastics manufactured with ECM’s 

technology. (RPFF ¶ 2672).58 While it is not the case that ECM plastics are non-biodegradable, 

those products are not expected to degrade rapidly and, so, manufacturers of compostable 

technologies can use the unscientific claim language in the ASTM protocols to limit marketing 

claims by competitors. 

The same outcome occurs with Complaint Counsel’s definition of “biodegradable” which 

includes the narrow one-year limit. If Complaint Counsel succeeds in this case, products that 

cannot achieve rapid degradation in short periods of time will essentially be outlawed because 

under the One Year Rule they cannot lawfully communicate to the market that they are 

biodegradable when they degrade in a period of time greater than a year. Makers of compostable 

products, like some bioplastics or oxodegradable polymers, stand to gain a substantial market 

advantage as a direct and predictable result of the One Year Rule and Complaint Counsel’s 

campaign of enforcement. (RPFF ¶¶ 322–23, 1412). After all, compostable products cost 

substantially more than the biodegradable additives (of which ECM is just one of many 

companies selling similar technologies) and without agencies of the government doing their 

bidding, the market favors ECM’s technology from a cost-benefit standpoint. (RPFF ¶¶ 328, 

330, 338, 345, 387, 706). Plastics manufacturers are less inclined to use the expensive 

                                                             56 Id. at 172. 

57 Id. at 263–264, 56. 

58 Id. at 89. 
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technology if a cheaper alternative exists that will produce an environmentally friendly, 

biodegradable plastic. (RPFF ¶¶ 636, 667, 671, 706). One solution is to restrict the market for 

“biodegradable” plastics such that only those expensive technologies qualify. Because the 

marketing interest lies primarily with “biodegradable” products, as opposed to biodegradable 

products that disappear within certain time periods, manufacturers are willing to pay for the most 

cost-effective product that satisfies the FTC’s definition of “biodegradable.” By eliminating 

alternatives through administrative regulation, ECM’s competitors gain market share. (RPFF ¶¶ 

322–23, 1412). 

That process was evident here, where for years ECM’s competitors directly lobbied FTC 

attorneys to pursue enforcement action against additive companies, including ECM. (RPFF ¶¶ 

1413–19).59 Representatives from BPI had open channels to FTC attorneys and frequently 

reported marketing claims by additive companies. (RPFF ¶ 1417).60 ECM competitors, like 

Metabolix, Inc., the benefactor of Complaint Counsel’s expert Stephen McCarthy, also lobbied 

for enforcement against additive companies and, in particular, against ECM. (RPFF ¶¶ 1413–

15).61 Groups like the BPI, and scientists affiliated with same, zealously lobbied the ASTM to 

incorporate limited language in biodegradability test standards that would (unscientifically) limit 

claim language based on test results. (RPFF ¶ 1416).62 Finally, organizations like the BPI 

commissioned biased and methodologically unsound consumer perception studies in an attempt 

to persuade the FTC that end-consumers preferred rapidly degrading plastic products. (RPFF ¶¶ 

826, 854). Whether wittingly or not, the Commission has rewarded those efforts by directly 

incorporating sections of BPI’s comments (almost verbatim) into the 2012 Green Guide 

                                                             59 See, e.g., RX 211. 

60 See, e.g., RX 718–RX 733. 

61 RX 211. 

62 See, e.g., RX 741. 
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revisions, and through enforcement actions such as that against ECM memorializing the arbitrary 

concept that a product must fully degrade within one year before it can be considered 

“biodegradable.” 

Perhaps in an effort to limit exposure to an apparent constitutional infirmity, the FTC 

explained in 16 C.F.R. § 260.8(c) that “unqualified” biodegradability claims were deceptive 

unless evidence showed complete degradation within one year, perhaps leaving room for 

qualified claims. In Section 260.8(d), the FTC explained that: 

Degradable claims should be qualified clearly and prominently to the extent 

necessary to avoid deception about: 

(1) The product’s or package’s ability to degrade in the environment 

where it is customarily disposed; and 

(2) The rate and extent of degradation. 

See 16 C.F.R. § 260.8(d). That language is illusory, however, because there are no test methods 

sufficient to satisfy Complaint Counsel’s heavy standards to prove a precise rate and extent of 

degradation occurring in a landfill environment (whether in landfills generally, specific landfills, 

or specific locations within individual landfills), nor could there ever be because so many 

variables affect the rate of biodegradation that it must be accepted as varying from location to 

location and time to time. (RPFF ¶¶ 1582, 1640–43, 1713, 1723, 1815, 1851, 1871–76). 

In this case, Complaint Counsel has criticized ECM’s reliance on ASTM standards 

because they do not “simulate or replicate” the landfill environment63 (contradicting their own 

experts; Dr. Michel cleaves to ASTM standard D5511 as a demonstrative test of biodegradation 

and Dr. McCarthy has relied on gas evolution tests to prove biodegradability throughout his 

career). (RPFF ¶ 2919). Complaint Counsel’s own experts have repeatedly used the very 

                                                             63 See, e.g., RX 851 (Tolaymat, Dep. at 126–127).
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methodologies Complaint Counsel condemn to prove that products biodegrade. (RPFF ¶¶ 1546 

(McCarthy), 2768 (Tolaymat), 2917 (Michel)).64 More significantly, Complaint Counsel and its 

experts have never explained precisely what type of scientific testing would be sufficient to show 

that a product biodegrades at a certain rate or to a certain extent within variable landfill 

environments (nor can they given that variability). (RPFF ¶¶ 1581–1605). When asked directly 

to explain what type of testing would be sufficient, an element to which Complaint Counsel has 

the burden, Complaint Counsel’s experts demur, answering evasively and inconsistently. (RPFF 

¶¶ 1581–88).65 

Under its demanding (and unrealistic) definition of “biodegradation,” no expert for 

Complaint Counsel has been able to identify the type, and accessibility, of evidence adequate to 

form a reasonable basis for making claims of biodegradability. See In re Pfizer Inc., 81 F.T.C. 

23 (1972). Its construct is a straw man, bereft of a competent scientific or survey evidentiary 

foundation, and calls for a set rate when nature delivers only variable rates. Indeed, even were 

the one year time limit applied to compostables, which the Commission in its rules and 

Complaint Counsel in its enforcement have assiduously avoided, the one year limit and the 

complete degradation requirement would not be capable of satisfaction. That is because the 

variable conditions in the environment, and particularly in landfills, make presupposition of a 

precise rate and extent of biodegradation impossible. (RPFF ¶¶ 1581–1605). 

                                                             64 See RX 362. 

65 Tolaymat, Tr. 218–19, 237–38, 239–54, 262–63, 296; McCarthy, Tr. 359–480. 
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The narrow FTC definition of biodegradation, and the absence of defined standards to 

support it, effects a change in national environmental policy due to its suppression of the entire 

non-compostable biodegradable plastics industry.66 

c. The So-Called “One Year” Rule Was Based on Deliberately 

Skewed Market Data that Is Not Reflective of Actual Consumer 

Impression 

For more than twenty years the FTC has required in 16 C.F.R. §§ 260.7–260.8 that 

companies possess evidence that a product or package “will completely break down and return to 

nature, i.e., decompose into elements found in nature within a reasonable short period of time 

after customary disposal.” However the concept of a “reasonably short period of time” was 

never defined, until 2012 when the FTC expressly stated: 

It is deceptive to make an unqualified degradable claim for items entering the 

solid waste stream if the items do not completely decompose within one year 

after customary disposal. Unqualified degradable claims for items that are 

customarily disposed in landfills, incinerators, and recycling facilities are 

deceptive because these locations do not present conditions in which complete 

decomposition will occur within one year. 

See 16 C.F.R. § 260.8(c) (emphasis added). Because the overwhelming majority of products are 

destined for Municipal Solid Waste (MSW) landfills (73.89%),67 that so-called “One Year Rule” 

effectively defined the term “biodegradable” for nearly all disposable consumer goods. As 

                                                             66 The FTC’s nearly flawless record in administrative enforcement actions only adds to 

any apprehension. See David Balto, “FTC’s winning streak is over,” TheHill.com (Feb. 11, 

2014) (quoting Chairman of the House Judiciary antitrust subcommittee Spencer Bachus (RAla.): “With this kind of record and an unbeaten streak that Perry Mason would envy, a company 

might wonder whether it is worth putting up a defense at all in a system in which the FTC brings 

a complaint, the case is tried before an administrative law judge at the FTC, and the FTC holds 

the authority to overturn a decision adverse to the agency”). 

67 RX 511, at 13. 
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explained below, the One Year Rule contradicts generally accepted peer-reviewed science on 

biodegradation, which defines biodegradation as a process without an arbitrary one year limit. 

The landfill environment is highly variable and heterogeneous, from one landfill to the 

next, but also within each landfill itself, making commonly known biodegradable substances, 

like banana peels, orange peels, tree trunks, and paper not reliably biodegradable within a single 

year or to the extent of a complete break down into elements found in nature.68 (RPFF ¶¶ 1582, 

1640–43, 1713, 1723, 1815, 1851, 1871–76). Predicting precise rates of degradation sufficient 

to satisfy the Commission is thus scientifically impossible, whether the product is an additive, 

like ECM’s, or a compostable product, like those favored by the FTC’s compostable rule, 16 

C.F.R. § 260.7(b), which contrary to the biodegradation rule, 16 C.F.R. § 260.8, includes neither 

a time limit nor a complete break down into elements found in nature requirement. 

 The One Year Rule is scientifically baseless. Experts agree that even the most 

biodegradable substances (including food waste, etc.) will not biodegrade in an MSW landfill 

within one year. (RPFF ¶¶ 804, 805, 1523, 1538).69 That means the FTC’s “One Year Rule,” 

which defines the “reasonably short period of time” for degradation, is unattainable for every 

single product on the market. Although the rule effects national environmental policy governing 

waste disposal, the rule was based not on sound science, but on what the FTC claimed was 

consumer perception of degradable claims.70 When national environmental policy is effectively 

struck based on consumer perception (which, as we shall see is a misperception of public opinion 

in any event), it replaces rational science with arbitrary and capricious decision-making and it 

                                                             68 See CCX 893, at 8 (noting that composting accounts for just 11% of disposal waste 

when recycling is excluded). 

69 See RX 853, at 11; CCX 893, at 16. 

70 See Green Guide Policies, at 3.2 
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succeeds in aggravating rather than militating the environmental goal of lessening pollution. 

(RPFF ¶¶ 1594–1605). 

 The FTC explained that its One Year Rule was supported by “[t]he available consumer 

perception evidence.” 71 FTC explained that: 

In a survey by APCO Insight, 60 percent of respondents expected that an item 

marketed as degradable without qualification will fully decompose in less 

than one year. The Commission concludes that this survey is a more reliable 

indicator of consumer perception than the Synovate study in which only 25 

percent of respondents had the same expectation.72

In doing so, the Commission rejected another survey that had a higher sample size (the Synovate 

study).73 In the Synovate study, ninety-three percent (93%) of all respondents thought it was 

acceptable to label a product “biodegradable” provided the product would decompose in a 

landfill.74 The FTC rejected the Synovate study and based its Green Guide recommendations on 

the APCO study instead.75 FTC explained that “[b]oth studies may be faulted for lacking control 

groups and presenting the timeframe questions with close-ended, rather than open-ended, 

answers, but they nevertheless are the only studies in the record.”76 Based on a well-designed 

telephone survey from Dr. David Stewart, ECM here presents current and reliable survey 

evidence that establishes the One Year Rule to be void of a basis in consumer perception and, 

thus, wholly arbitrary and capricious. (RPFF ¶¶ 1105–1344).77

 The FTC chose the APCO study because, “[u]nlike the APCO study, the Synovate study 

results suggest that respondents’ answers may have been not only biased, but also influenced by 

                                                             71 RX 195, at 121. 

72 RX 195. 73 RX 195 at 118–122. 

74 RX 673. 

75 RX 195, at 118–122. 

76 Id. at 121 n. 409 (emphasis added). 

77 RX 856. 
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a tendency to avoid extreme answers.”78 FTC also explained that “respondents were informed 

that ‘non-biodegradable plastic products take hundreds of years to decompose,’” but “[s]uch 

statements are absent from most marketing contexts, and did not appear in the APCO 

questionnaire.”79 Moreover, according to FTC, the design of the Synovate study revealed a 

“pattern of responses, together with the absence of choices in the range of less than one year,” 

which “suggests that some respondents were avoiding an extreme response.”80 Accordingly, the 

“Commission conclude[d] that the proportion of consumers expecting full decomposition in 

under one year would be closer to 60 percent rather than 25 percent.”81 

 ECM’s expert in consumer psychology often relied upon by the Commission and FTC 

Administrative Law Judges, Dr. David Stewart, testified that the One Year Rule was based on 

flawed evidence and remains uncured by the patently unreliable Google Consumer Survey 

evidence from Complaint Counsel’s expert, Dr. Shane Frederick. (RPFF ¶¶ 826, 848, 850–55, 

865, 870–71, 877).82 Dr. Stewart testified, and his consumer survey data revealed, that no 

consensus exists (not even from a significant minority of consumers) as to the meaning of the 

term biodegradable or as to an expectation of a precise time within which a plastic would 

biodegrade. (RPFF ¶¶ 1315–18, 1331–36). Indeed, a whopping 98% of respondents explained 

that they expected biodegradation rates to vary dependent upon variable environmental 

conditions and the type of plastic involved. (RPFF ¶ 1311). In short, as to rate of 

biodegradation, consumers expect it to vary and do not expect reliable achievement of complete 

biodegradation within one year after customary disposal. (RPFF ¶ 1312). 

                                                             78 RX 195, at 121. 

79 Id. at 122. 

80 Id. at 195.

81 RX 195. 82 RX 856. 
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The so-called “reasonably short period of time” for degradation after customary disposal 

must be examined through the scientific evidence, which reveals that void of biodegradable 

additives conventional plastics will last, at least, for thousands of years in the environment. 

Thus, plastics which biodegrade in decades, or even hundreds of years, are environmentally 

beneficial as they degrade in reasonably short periods of time when compared with nonbiodegradable plastics. The evidence shows that ECM plastics should be compared not with an 

arbitrary and capricious “One Year Rule,” but with untreated plastics that have an almost 

indefinite existence in the environment. 

D. Complaint Counsel Failed to Meet Their Burden of Showing that ECM’s 

Unqualified Biodegradation Claim Is False or Misleading in Any Material 

Respect 

ECM Biofilms has proven that plastics made with its additive technology will biodegrade 

within a reasonably short period of time under conditions of customary disposal, particularly 

when compared with conventional, untreated plastic products. “Two theories have been used to 

prove that an advertisement is deceptive or misleading: (1) the ‘falsity’ theory or (2) the 

‘reasonable basis’ theory.” In the Matter of Pom Wonderful LLC, 9344, 2012 WL 2340406 

(F.T.C. May 17, 2012) (at 234) (citing Pantron I, 33 F.3d at 1096). Where the “issue of whether 

Respondents’ claims were deceptive turns on the nature and quality of Respondents’ 

substantiation ... the falsity and reasonable basis theories collapse into the same inquiry: did 

[Respondents] possess adequate substantiation to make such a claim?” Id. (quoting FTC v. QT, 

Inc., 448 F.Supp. 2d 908, 966 (N.D. Ill. 2006)). 

Proof of deception requires an analysis of the evidence as follows: 

[T]he Court must first determine what level of substantiation Defendants 

were required to have for their advertising claims, and this determination is 

a question of fact. Then, the Court must determine whether the Defendants 
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possessed that level of substantiation ... Defendants have the burden of 

establishing what substantiation they relied on for their product claims. The 

FTC has the burden of proving that the Defendants’ purported substantiation 

is inadequate... 

FTC v. QT, Inc., 448 F. Supp. 2d at 959 (citations omitted). For efficacy claims, the 

Commission must determine the level of substantiation by applying the Pfizer factors. In re 

Pfizer, Inc., 81 F.T.C. 23 (July 11, 1972). 

In sum, ECM has produced competent and reliable scientific evidence proving that 

plastics manufactured with its additive biodegrade anaerobically and aerobically. ECM’s 

laboratory testing, in light of the totality of scientific evidence, prove that ECM’s additive causes 

plastics infused with it to be biodegradable in biologically active landfills.83

First, ECM has produced 30+ independently performed gas evolution studies that tested 

various ECM-infused plastics of ECM customers against negative controls (i.e., untreated, 

conventional plastics that are known to degrade very slowly). Those tests included anaerobic lab 

work (e.g., ASTM D5511, BMP), and aerobic lab work related to composting (e.g., ISO 14855, 

UNI EN 14046). (RPFF ¶¶ 2129–2659). Results in those 30+ tests revealed biodegradation of 

the ECM plastic, not the additive alone. (RPFF ¶¶ 1899–1933, 1964–2037, 2129–2659). The 

biodegradation was measured by the amount of gas produced. (RPFF ¶¶ 1964–2009, 2129–

2659). Researchers can determine the amount of biodegradation in the test article by comparing 

the carbon in the gas emitted from treated vessels with the carbon emitted in the blank inoculum 

and the control vessels. (RPFF ¶¶ 1964, 2202). The amounts of biodegradation observed in 

ECM’s many positive tests was sufficient to conclude that the plastic polymer, and not just the 

ECM additive, had biodegraded substantially. (RPFF ¶¶ 1964–2009; 2129–2659). The accuracy 

                                                             83 See infra at 117 (table). 
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of those results was also confirmed by D6579 testing that compared molecular weights of the 

negative control versus the test plastic after biodegradation testing. (RX 838 at 73). 

Second, ECM supported its gas evolution data with qualitative analyses performed by 

leading environmental scientists. (RPFF ¶¶ 2660–2706). Tests of the ECM additive infused 

plastics in landfill simulated conditions demonstrated that the plastic was biodegradable by 

gravimetric endpoints. (RPFF ¶¶ 2693–94). Dr. Timothy Barber (Environ Labs) further 

concluded that the ECM additive caused PVC polymers to degrade under simulated landfill 

conditions based, in part, on gravimetric endpoints, but also through an evaluation of free 

chloride atoms present in the test vessels. (RPFF ¶¶ 2694–2697). 

Third, ECM confirmed that anaerobic biodegradation witnessed in the laboratory 

environment would translate into the real word conditions of a landfill. ECM has proven that 

Municipal Solid Waste (MSW) landfills are biologically active enough to support significant 

biodegradation in most instances. (RPFF ¶¶ 1810–1898). The anaerobic processes that result in 

landfill biodegradation are similarly present in the laboratory tests. (RPFF ¶¶ 2041–42). 

Moreover, the laboratory tests demonstrate that ECM plastics are intrinsically biodegradable 

when compared with untreated plastics. (RPFF ¶ 1814). As a biodegradable material, the 

plastics will biodegrade when environmentally favorable conditions exist for biodegradation. 

(RPFF ¶ 1628). 

Fourth, ECM determined through various studies, including extended gas evolution 

studies and those where labs re-inoculated, that biodegradation of plastics would continue 

beyond the short testing periods so long as living biota remained present. The primary question 

is whether plastic made with the ECM additive is intrinsically biodegradable, to which one of the 

leading authorities in landfill science, Dr. Barlaz, testified in the affirmative. (Barlaz, Tr. 2218). 
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Because if the plastic is “biodegradable,” it will continue to biodegrade whenever the 

environmental conditions support same, just like a piece of copy paper. (Barlaz, Tr. 2217-18). 

Where tests have shown a decrease in biodegradability, ECM’s experts have explained that the 

test environment is almost always the cause, because closed-system laboratory tests are not 

designed to be operated for long duration tests, and the microorganisms will die over time. 

Fifth, ECM determined based on peer-reviewed literature and expert opinion that 

conventional plastics of the type most ECM customers use can be enzymatically biodegraded by 

enzymes naturally produced by bacteria and microorganisms. (RPFF ¶¶ 1629–70, 1699–1765). 

Sixth, ECM has debunked the scientific theories posited by Complaint Counsel’s experts 

in their efforts to prove that additive technologies (not just ECM’s) are inefficacious. Each of 

those arguments are theoretical, never once proven through actual testing. For example, 

Complaint Counsel speculates (together with its experts Drs. McCarthy and Michel) that a 

“priming effect” could have been responsible for positive test data in ECM’s testing. (RPFF ¶¶ 

2010–37, 2083–85, 2121–28). However, they present no scientific evidence of the effect 

occurring in anaerobic environments and make no attempt through the record evidence to prove 

the theory. They also offer no proof in the peer-reviewed literature for their theory, and each of 

ECM’s experts believed the theory unproven and unreliable. Indeed, Dr. Barlaz affirmatively 

proved based on a statistical analysis of the results contained in tests of ECM additive containing 

plastics that the amount of biodegradation present could not be attributed to the additive alone 

but had to arise from the plastics themselves. (RPFF ¶¶ 2129–2885). 

Complaint Counsel’s expert Dr. McCarthy, the foremost proponent of the “priming 

effect” theory in this case is not a credible witness. Dr. McCarthy essentially works for ECM’s 

competitors, most notably Metabolix, his primary sponsor at UMass-Lowell. (RPFF ¶¶ 1398–
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1406). He has received substantial research funding (millions of dollars) from Metabolix. The 

intellectual property he invented that was patented in the ‘199 patent (RX 761; RX 757) is 

exclusively licensed to Metabolix, and provided McCarthy and UMass Lowell royalties. (RPFF 

¶¶ 1399–1404). He is, therefore, personally and financially interested in the success of ECM’s 

competitors, who, in turn, stand to profit if the FTC forecloses the biodegradable additive 

industry. The same competitors who hire Dr. McCarthy have directly lobbied the FTC to act 

against additive manufacturers, including ECM by name. (RPFF ¶¶ 1413–14). 

In FTC proceedings, credibility is always in issue. (ALJ, Tr. 1526, 1706). It is for the 

judge to make character findings in instances where testimony, particularly of experts, is evasive, 

false, misleading, or perjurious. Cota v. Tucson Police Dep’t, 783 F. Supp. 458, 464 (D. Ariz. 

1992) (“When sitting as a finder of fact, a trial judge necessarily determines the credibility of 

expert witnesses.”). Dr. McCarthy’s expert opinions are unreliable not only because he has a 

direct financial stake in the outcome of the litigation (which, itself, is disqualifying84), but also 

because his testimony repeatedly dissembled with numerous contradictions evinced between his 

statements at hearing and those at deposition. (RPFF ¶¶ 1360–1580). 

ECM’s experts, including the proffered expert Dr. Grossman (Dr. McCarthy’s colleague), 

have all testified to fundamental flaws and lack of scientific integrity in Dr. McCarthy’s 

scientific analysis in this case.85

                                                             84 “[T]he nature and extent of a witness’s motives and his interest in the outcome of the 

case bear importantly upon an evaluation of the witness’s objectivity, his bias, and the weight to 

be accorded his testimony.” United States v. IBM Corp., 66 F.R.D. 215, 219 (S.D.N.Y. 1974); 

Nemir v. Mitsubishi Motors Corp., 200 F.Supp.2d 770, 774 (E.D. MI 2002) (“The more 

subjective and controversial the expert's inquiry, the more likely the testimony should be 

excluded as unreliable.”). 

85 See, e.g., Sahu, Tr. 1772–73 (explaining that Dr. McCarthy’s litigation definition of 

“biodegradable” is not found anywhere in the peer reviewed literature); Sahu, Tr. 1871 

(testifying that Dr. McCarthy’s theory on pro-oxidants as an exclusive means to promote 
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Finally, no test failing to show biodegradation of a plastic infused with the ECM additive 

was subject to any causal analysis sufficient to prove that the additive failed to biodegrade as 

opposed to other causative bases for test failing, such as death of the bacteria in the inoculum, 

mis-manufacture of the test plastic, the presence of anti-microbial additives in the test plastic, or 

other ambient environmental conditions in the test environment not hospitable to biodegradation. 

(RPFF ¶¶ 2886–2908). Thus, each test failing to show biodegradation of the test plastic begets a 

question, not an answer, unless an evaluation is undertaken to determine causality. Failed tests 

without a causal nexus remain inconclusive, not negative, and cannot be deemed proof that the 

ECM additive itself failed to cause the plastic in issue to biodegrade. (RPFF ¶¶ 2886–2908). 

Moreover, in light of Dr. Barlaz’s analysis of the tests that do show biodegradation of 

plastics infused with the ECM additive, ECM has particular proof that the plastic, and not the 

additive alone, biodegraded. That affirmative proof is causally based and definitive. Thus, the 

totality of the scientific evidence, consists of numerous tests showing plastics themselves 

biodegrading when infused with the ECM additive and a subset of tests that were inconclusive. 

The inconclusive tests do not in any way negate the affirmative proof because they do not 

involve causal proof that the ECM additive was incapable of performing as opposed to other 

ambient test conditions required for a valid assessment. (RPFF ¶¶ 2886–2908). 

 

1. ECM Additive Efficacy Depends on Strict Adherence to ECM 

Manufacturing Instructions 

                                                                                                                                                                                               

biodegradation is not supported); Sahu, Tr. 1894–97 (explaining that Dr. McCarthy’s use of gas 

evolution testing contradicts Dr. McCarthy’s own testimony); Barlaz, Tr. 2247 (explaining that 

Dr. McCarthy’s decision to completely dismiss all ECM testing was surprising and unscientific); 

Barlaz, Tr. 2277–80 (explaining that Dr. McCarthy’s priming effect theory is not supported); 

Burnette, Tr. 2400 (explaining that, as a microbiologist, Dr. Burnette had never observed or seen 

in research a priming effect theory that Dr. McCarthy posited). 
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ECM sells a “MasterBatch Pellet” that includes a biodegradable component along with an 

otherwise non-biodegradable (or conventional) plastic carrier resin. (RPFF ¶¶ 1671; RX 371; RX 

656; RX 681). The formula for the “active” component is a trade secret. (RPFF ¶ 2; RX 371). 

ECM offers a “load rate” of 70% in its pellets, meaning that every pellet will contain 

approximately 70% of the “active” biodegradable formula, along with 30% conventional 

polymer resin. (RPFF ¶ 744). ECM prescribes that plastics manufacturers blend the pellet into 

their plastics according to precise instructions and at a 1% rate, resulting in a uniform 

distribution of the pellet throughout the plastic and at a level that ensures maximum utility 

without compromising the plastic or the additive’s integrity. (RPFF ¶ 745).

Like many other plastic additives (e.g., coloring agents), manufacturers introduce the 

ECM additive into the plastic during the initial blending process. (RPFF ¶¶ 747–49). Plastics 

are commonly manufactured using one of several techniques, including extrusion molding, 

injection molding, or blow molding. (RPFF ¶ 750). For instance, extrusion molding involves a 

heated plastic compound continuously injected through a long die cast in the desired shape. 

(RPFF ¶ 751). The plastic is cooled under blown air and hardens into items such as thin films 

which are eventually coiled or cut. The manufacturing process, while common to many plastics 

manufacturers, can be complicated as the manufacturer must achieve a uniform distribution of 

the ECM additive in the final product for the additive to work. (RPFF ¶ 745). ECM issues 

certificates of biodegradability to customers only after those customers have signed letters 

pledging to maintain the 1% load at a uniform distribution in the plastic. (RPFF ¶ 1345). 

Moreover, ECM customers have experienced burning and scorching of the additive as they 
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attempt to adjust their manufacturing process. (RPFF ¶¶ 363, 1675–77; RX 130).86 Burning or 

scorching of the additive is one manufacturing error that can render the ECM additive 

inefficacious. (RPFF ¶ 1675). Similarly, failing to include the additive in sufficient amounts or 

in a uniform distribution would also render the additive ineffective. (RPFF ¶¶ 764–65). Because 

the additive is hydroscopic, leaving open ECM’s moisture sealed container in which the additive 

is transported can also render the additive ineffective. (RPFF ¶¶ 762–63). 

ECM’s customers manufacture many plastic polymers, but the bulk of the plastics 

incorporating ECM’s technology consist of three: polypropylene (PP), polystyrene (PS), and 

polyethylenes (PE). (RX 458; RX 522). Over seventy (70) percent of ECM plastics are PE 

plastics. (RPFF ¶ 754). 

ECM offers a cost-effective means to achieve biodegradable plastics. (RPFF ¶ 41; RX 

335). There are competing technologies available, such as “bioplastics,” which are 

biodegradable plastic polymers or resins derived from biological substances instead of 

petroleum. (RPFF ¶¶ 325–26); RX 748; RX 678). Bioplastic can be non-biodegradable, such as 

bio-based polyethylene, or they can be biodegradable such as PHA. Many of those technologies 

will produce an end-product that biodegrades more rapidly or readily in an industrial composting 

operation than plastics made with the ECM additive in a landfill. (RPFF ¶ 327; RX 725; RX 

178). However, those competing technologies come at a substantial cost and risk to 

functionality. (RPFF ¶ 328; RX 335). Companies choosing to invest in most bioplastics must 

change their entire manufacturing process to accommodate the use of the new natural resins. 

                                                             86 Customers have observed difficulties in manufacturing plastics with the ECM additive, 

and have needed to incrementally adjust their manufacturing system to avoid burning. See, e.g., 

RX 130 at 007221 (based on temperature and other manufacturing settings, the ECM customer 

“had poor adhesion as well as unacceptable edge weave and pulsing in the die. The outer edges 

of the resin coming out of the die were brown in color” which would indicate burning). 
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(RPFF ¶ 333; RX 520). The bio-based polymers are almost always significantly more 

expensive. (RPFF ¶¶ 333, 338). Additional additives are needed to stabilize the bioplastics for 

the intended use of the end product. (RPFF ¶ 335). After all, the primary purpose of a plastic 

product is to serve a function in the market which may demand considerable tensile strength and 

rigidity, not to biodegrade in landfills. The bioplastics are often suitable only for certain limited 

uses in the market. (RPFF ¶¶ 346, 328–48). There are thus many reasons why a plastics 

manufacturer might not be able (or not want) to use competing technologies that come at 

substantial cost and may compromise plastic strength or functionality. (RPFF ¶¶ 328–48). 

ECM’s customers balance the need for their product’s performance (i.e., tensile strength, 

shelf-life, etc.) with the objective of achieving greater plastic biodegradability. (RPFF ¶¶ 344–

45).87 They must ensure that the product meets consumer use expectations first and foremost and 

thereafter ensure that biodegradability is hastened after customary disposal. Favoring a too rapid 

biodegradation ordinarily necessitates diminution of tensile strength, shelf-life, etc. (RPFF ¶¶ 

334, 340, 347). ECM customers perform testing on their finished ECM-infused plastic before 

ordering product precisely to determine if biodegradability occurs in ways that will not 

compromise product functionality when in use. (RPFF ¶ 401; RX 413; RX 412). Because the 

ECM additive can accomplish a biodegradable plastic with load rates of just over 1% by weight 

and ordinarily do so without compromising plastic functionality when in use, plastics 

manufacturers’ dual goals of functionality and biodegradability can be satisfied. (RPFF ¶¶ 338–

48; RX 326; RX 520). On balance, then, they can satisfy customer demand for functionality and 

                                                             87 See, e.g., CCX 811 (Hong, Dep. at 44)) (noting that the company experimented for one 

year with ECM’s additive to determine if it could be incorporated into their process). As 

explained by the manufacturer, “ECM at that time said it’s biodegradable, but it doesn’t do us 

any good if we can’t use it through our machines. So what we were doing was putting the 

additive inside of our plastics to see if it could actually run through our extruders and then be cut 

and sealed as plastic bags.” Id.
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also promote their interest in lessening environmental impact by causing a plastic to break down 

faster than it otherwise would without the ECM additive present after that plastic is discarded. 

The ECM additive thus offers manufacturers the flexibility to add a biodegradable plastic to their 

line, without having to substantially alter business operations or disappoint consumers. (RPFF 

¶¶ 339–40). 

2. The Type of Scientific Evidence That Experts Agree is Competent and 

Reliable to Prove Biodegradability 

The amount of substantiation experts in the field would agree is reasonable “must be 

examined in relation to each field being evaluated.” POM, 2012 WL 2340406, at *206. 

Currently, for “biodegradation” studies, all experts agree that gas evolution laboratory-scale 

reactor tests are competent and reliable evidence, which evidence ECM has produced more than 

two dozen favorable tests. (RPFF ¶¶ 2129–2659). 

The FTC has not defined what constitutes “competent and reliable scientific evidence” in 

the context of biodegradable advertising. However, based on the Pfizer factors, the standard to 

be applied in this case must be lower than standards applied in other FTC proceedings that 

concern advertisements containing medical or health claims. For example, in the medical 

context, the Commission demands that advertising claims be substantiated by double-blind, 

randomized, placebo-controlled clinical trials. Thompson Med. Co., Inc. v. Fed. Trade Comm'n, 

791 F.2d 189 (D.C.Cir.1986); Bristol-Myers Co. v. Fed. Trade Comm'n, 738 F.2d 554 (2d 

Cir.1984); In the Matter of Pom Wonderful LLC, Roll Global LLC, Stewart A. Resnick, Lynda 

Rae Resnick & Matthew Tupper, 155 F.T.C. 1, 28 (2013). The standard to apply in this case 

must necessarily be lower than the standard for advertising claims related to food products which 

purport to have health benefits—“one well designed, randomized, and double-blind, placebo-
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controlled clinical trial involving an appropriate sample population and endpoint.” POM, 2013 

WL 268926, at *43. While these standards obviously cannot apply to biodegradability, they are 

important benchmarks to demonstrate that ECM’s “competent and reliable scientific evidence” 

need not be as high as that mandated in Thompson, Bristol-Myers, and POM, which standard 

was, essentially, of the more demanding thresholds suggested by the experts. See Statement of 

Commissioner Ohlhausen, 2014 WL 587857, at *1 (F.T.C. Jan. 7, 2014) (“[T]he burden for 

substantiation for health- or disease-related claims about a safe product . . . should be lower than 

the burdens imposed on drugs and biologics because consumers face lower risks when 

consuming the safe product.”). In assaying what is “reasonable” to prove efficacy claims, the 

proper point of reference is what the scientific community considers reliable proof. In that 

regard, the record from ECM experts and Complaint Counsel’s own is clear: gas evolution 

testing, of the kind relied upon by ECM here, is generally accepted (even relied upon by 

McCarthy in practice despite his expert report statements to the contrary). (RPFF ¶¶ 1467, 

1766). That evidence, complemented by a detailed explanation of the mechanism of action 

derived from basic science, support the conclusion that the ECM additive causes plastics to 

biodegrade faster than plastics lacking infusion of the additive. (RPFF ¶¶ 1581-2706). 

3. The Absence of Any Standards or Tests to Prove Rates of Biodegradation 

in Landfills 

In assessing whether a Respondent possessed a reasonable basis, this Court must first 

determine what level of substantiation the advertiser is required to have for advertising claims. 

FTC v. Pantron I Corp., 33 F.3d 1088, 1096 (9th Cir. 1994); FTC v. Sabal, 32 F.Supp. 2d 1004, 

1008-09 (N.D. Ill. 1998). Complaint Counsel has offered no proof whatsoever of what scientific 

evidence would be sufficient to support biodegradable “rate” claims in landfills. (RPFF ¶¶ 
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1581–1605). Because Complaint Counsel contends that ECM should have made a qualified 

claim that involved the “rate” of biodegradation under the “One Year Rule,” and the absence of a 

“rate” is a central issue in their request for relief, the absence of record evidence on “rate” testing 

means Complaint Counsel cannot support essential aspects of its case. Moreover, because there 

is no generally accepted method to test for “rate,” the scientific materiality of rate claims is nil. 

Dr. Barlaz testified that the primary scientific concern related to biodegradability is 

whether a material is intrinsically biodegradable, not whether it biodegrades within a certain time 

period in a particular location on earth, or particular location within a landfill. (RPFF ¶¶ 1891–

1898). For example, a piece of copy paper may biodegrade at varying rates and, in fact, it may 

never biodegrade unless the environmental conditions are appropriate, (Barlaz, Tr. 2218–19), yet 

no expert in this case disputes that paper is “biodegradable.” (Barlaz, Tr. 2218–19). ECM’s 

product testing, as explained below, proves that plastics properly infused with the ECM additive 

are intrinsically biodegradable, meaning that they will biodegrade in a reasonably short period of 

time compared with conventional plastics, provided the environmental conditions are suitable for 

biodegradation of biodegradable materials. (RPFF ¶¶ 1899–1933, 1964–2009, 2129–2885). 

That, indeed, is the qualified claim ECM gives to its customers wherein it routinely explains that 

the ECM additive will cause plastics to biodegrade in environments where organic matter is 

biodegrading. (RPFF ¶¶ 320, 377, 1352). 

Landfill environments are alive with biodegrading material but are highly variable in the 

rates of biodegradation from one location to the next and even within points in a single landfill. 

(RPFF ¶¶ 1582, 1640–44). Moisture levels, temperature, and surrounding materials (e.g., foods 

waste, paper, wood, yard clippings, etc.) vary dramatically even within the same landfill. (RPFF 

¶¶ 1582, 1640–44, 2065, 2807). That variability renders a precise prediction of rates of 
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biodegradation impossible, because the very same article may biodegrade almost not at all on 

one side of a landfill, but rapidly biodegrade on the other. (RPFF ¶¶ 1581–1605, 1723). 

Because of that variability, no one can predict the precise environmental conditions of disposal, 

ergo adding to the illogic and arbitrariness of Complaint Counsel’s definition of biodegradation 

as necessitating 100% break down into elements in nature within one year of customary disposal. 

Complaint Counsel provided no testimony or evidence concerning what competent and 

reliable evidence would be required to prove the rate that a product will biodegrade in an MSW 

landfill. (RPFF ¶¶ 1581–1605). No expert, including none of Complaint Counsel’s experts, 

provided any evidence establishing the type or sufficiency of scientific proof that ECM should 

have possessed to support rate claims. (RPFF ¶¶ 1581–1605). Rather, biodegradation rate is 

generally understood to be a variable condition, dependent upon numerous environmental 

factors. (RPFF ¶¶ 1581–1605, 1723). 

When questioned repeatedly concerning which tests, if any, can be used to prove the rate 

of biodegradation in an MSW Landfill, Dr. Tolaymat testified evasively, providing no clear 

answer. (Tolaymat, Tr. 219–21). He explained that no one test could establish the rate of 

biodegradability. (Tolaymat, Tr. 261–62). He made no attempt to explain what kind and 

quantity of evidence, if any, would support the type of rate qualifiers in Complaint Counsel’s 

proposed Order filed earlier in this case. (RX 851 (Tolaymat, Dep. at 120)). He did, however, 

concede, against the avowed position of Complaint Counsel, that gas evolution studies like the 

ASTM D5511 and BMP tests were competent and reliable to test for intrinsic biodegradability. 

(RPFF ¶¶ 2751–52). 

Dr. McCarthy did not provide testimony concerning the specific type of testing required 

to demonstrate the rate of biodegradation in an MSW landfill. (McCarthy, Tr. 359–480). He 
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did, however, testify at length concerning the types of scientific studies that might be used to 

assess biodegradability of polymers generally, including gas evolution tests of the type ECM 

presented in this case. (McCarthy, Tr. 359–480). Dr. McCarthy even testified that the “rate” of 

biodegradation can vary within a plastic, with faster rates for certain regions and slower rates for 

others (e.g., crystalline regions). (McCarthy, Tr. 477). Because the formation of crystalline 

regions of a polymer is unpredictable, variable, and depends on the manufacturing process, that 

means each specific plastic, like a fingerprint, could have a different overall lifespan and rate of 

biodegradation even if disposed under the identical conditions. 

Dr. Morton Barlaz testified that there was no uniformly accepted method to extrapolate 

rate data from laboratory scale testing to field-scale landfills. (Barlaz, Tr. 2282). He explained 

that it is “very, very difficult to measure rates at either – at field scale either for individual 

components or for bulk waste, so all we have is the lab.” (Barlaz, Tr. 2282). 

Dr. Barlaz also testified that the rate of biodegradation in landfills is largely irrelevant. 

(Barlaz, Tr. 2283–84; RX 853 (Barlaz, Dep. at 12). Because the residence of waste in a landfill 

is intended to be infinite, if a material is biodegradable, then it would not matter from a landfill 

science perspective if that material biodegrades within ten years or many years. (RX 853 

(Barlaz, Rep. at 12); Barlaz, Tr. 2283–84). In fact, products that would very rapidly biodegrade 

in landfills present environmental concerns because the methane released during that short and 

rapid biodegradation would not be captured by landfill operators. (Barlaz, Tr. 2284–85). 

Methane is produced when products biodegrade. (RPFF ¶¶ 1813, 1840). Methane is a 

powerful greenhouse gas emission that contributes to climate change. (Barlaz, Tr. 2285). As 

methane gas increases in the atmosphere, it contributes to warming of the atmosphere, which 

most environmental scientists believe damaging to the planet. (Barlaz, Tr. 2286). The EPA’s 
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Landfill Methane Outreach Program (LMPO) has an express mission to reduce greenhouse gases 

emitted from landfills. (RPFF ¶ 2877). Landfills remain one of the largest man-made sources 

for methane emissions on the planet. (RX 967). Yet EPA regulations do not require landfill 

owners to install gas collection systems until five years after waste burial. (Barlaz, Tr. 2285). 

If a product biodegrades completely within one year, that product will not take up space 

in a landfill, but the methane produced will not be captured and will have less desirous 

environmental consequences than simply storing the product in a landfill for a longer period of 

time. (Barlaz, Tr. 2285–86). Thus, through critically acclaimed research published in the peerreviewed literature, Dr. Barlaz demonstrated that based on decay rates the slower a product 

biodegrades in a landfill environment, the better that product is for the environment after 

disposal. (Barlaz, Tr. 2287–88). Dr. Barlaz explained: 

The reason we make products is for people to use them, not to throw them in a 

landfill... What we’re trying to do here is ask, given the fact that waste exists 

and waste is generated, what’s the best thing to do with it and what’s the best 

way to design a product, without impending its functionality, to minimize 

environmental impact.” 

(Barlaz, Tr. 2288). Complaint Counsel has offered no evidence that contradicts or rebuts that 

logical conclusion, which causes EPA policy in favor of reducing greenhouse gas emissions 

squarely at odds with Complaint Counsel’s biodegradation definition in favor of complete 

biodegradation of plastics within one year after customary disposal. Compare RX 967 (LMOP 

citing methane emissions as problematic greenhouse gases), and RPFF ¶¶ 1593–1605 (rapidly 

biodegrading products present a risk of increased methane emissions), with 16 C.F.R. § 260.8(c) 

(promoting rapidly degrading materials under mistaken theory that physical disappearance is, by 

itself, the only environmental objective). 
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4. Competent and Reliable Biodegradation Testing Methods Relevant to 

This Case 

Every expert in this case agreed that gas evolution laboratory testing is competent and 

reliable to assess biodegradability. (RPFF ¶¶ 1608–1628). In fact, each of Complaint Counsel’s 

relevant witnesses (Drs. Tolaymat, McCarthy, and Michel) actually relied on gas evolution 

testing when performing their own biodegradation tests outside of this litigation. (RPFF ¶¶ 

1608–1628). 

In 2010, Dr. Tolaymat chose a biomethane potential test, or “BMP,” to determine 

whether commercially available plastic products were biodegradable. (RPFF ¶ 2768). The BMP 

test is not at all representative of a landfill—at least not the landfill that Dr. Tolaymat envisions 

in his testimony. (RPFF ¶¶ 2756–2772). The BMP is a “liquid state” test operated under almost 

completely saturated moisture levels. (Barlaz, Tr. 2222). In many tests, the BMP also involves 

grinding or screening the test material, the use of nutrients to bolster the bacteria, and higher 

temperatures. (RPFF ¶¶ 1902–1904). Yet, Dr. Tolaymat himself chose to use that BMP test to 

specifically verify whether commercially available plastic products were biodegradable as they 

claimed. (RPFF ¶ 2768). Dr. Tolaymat even conceded in his expert report that ASTM D5511 

tests are competent and reliable to measure a product’s intrinsic biodegradability. (CCX 893) 

(“ASTM D5511 ... can provide data about anaerobic biodegradation”). Dr. Tolaymat has never 

run a carbon-14 test to determine the biodegradability of plastic polymers. (RPFF ¶ 2852). 

In 2012, Dr. Michel chose to run an ASTM D5511 gas evolution test to determine if 

various plastic polymers were anaerobically biodegradable. (RPFF ¶ 1772). Dr. Michel did not 

run a carbon-14 test. He has never run a carbon-14 radiolabeled test on plastic polymers. (RPFF 

¶ 1773). In fact, in his testimony, Dr. Michel zealously defended the use of a D5511 test to 

determine the biodegradable nature of a plastic product. (RPFF ¶ 1775). 
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Dr. McCarthy testified that gas evolution, or “respirometric” testing is used by scientists 

to assess biodegradability. (RPFF ¶ 1618; (McCarthy, Tr. 413–14). In 1999, Dr. McCarthy 

relied on gas evolution testing similar to the D5511 test to assess whether his plastic polymer 

blend with certain polyester plastics was biodegradable. Dr. McCarthy relied on that data, 

including evidence of only partial biodegradation, to conclude that his plastics were fully 

biodegradable without limitation. (RPFF ¶¶ 1540–50). In one such test, Dr. McCarthy observed 

14% biodegradation of a polymer (polylactic acid or PLA) after 45 days, which Dr. McCarthy 

defined in his ‘199 patent and in his testimony as a “biodegradable polymer.” (RPFF ¶¶ 1540–

50). 

ECM’s experts each testified that gas evolution tests are competent and reliable scientific 

evidence to assess biodegradation. Dr. Sahu testified that the laboratory reactor tests were 

generally relied upon by scientists to show the biodegradability of materials. (Sahu, Tr. 1792). 

Dr. Barlaz testified that data from gas evolution testing was competent and reliable evidence of 

biodegradability, and that scientists in the field generally rely on same, including D5511 tests. 

(Barlaz, Tr. 2245–46). Dr. Burnette testified that gas evolution tests, like the D5511 test, are 

useful for predicting some baseline performance in landfill settings. (Burnette, Tr. 2435–39). 

Thus, while other tests exist and are helpful to provide support of affirmation, none is 

generally used for proof of biodegradation other than the gas evolution tests used here in proof of 

ECM product efficacy. The competent and reliable evidence recognized by experts in the field 

remains gas evolution, laboratory-scale reactor testing. (RPFF ¶¶ 1766–1809). Carbon-14 

radiolabeled testing, even if feasible or practical, is experimental and is in fact ultimately a gas 

evolution test that is run just like an ASTM D5511 test only with the carbon-14 markers 

included. (RPFF ¶¶ 1771–1801). 
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Figure 2. Carbon dioxide diagram

(demonstrative)

a. Gas Evolution Reactor Tests (e.g., ASTM D5511) 

A gas evolution reaction is a chemical reaction that produces gas, in this case, methane 

and carbon dioxide.88 The process of biodegradation involves the cleavage of carbon bonds from 

the substrate, which are then combined with available hydrogen and oxygen to produce methane 

and carbon dioxide. (RPFF ¶ 1732).89 In a gas evolution test, the laboratory exposes test articles 

to conditions that theoretically favor biodegradation, and then gas emissions are monitored. 

(RPFF ¶ 1883–84, 1897). By comparing the levels of gas emitted from the test vessel, the 

laboratory can measure the amount of gas produced from the test articles themselves. (RPFF ¶ 

1912).90 Figures of methane and carbon dioxide gas are shown below: 

Gas evolution tests generally have several common characteristics. Within a closed, 

watertight vessel, test articles are exposed to “inoculum” that is comprised, in part, of leachate 

from local municipal waste stations. (RPFF ¶ 1909).91 The leachate therefore contains microbes 

that would also be present in the environment.92 Some tests bolster the inoculum by adding 

minerals and food to grow the bacterial colonies before the test period begins.93 Laboratories 

                                                             88 See RX 853 (Barlaz, Dep. at 8). 

89 Id. at 8–9. 

90 Id. at 8–9. 

91 See RX 385, at 3. 

92 See, e.g., RX 854 (Burnette, Rep. at 5–6). 

93 See CCX 84, at 3 (§ 9) (ASTM D5511 Standard). 

Figure 1. Methane diagram

(demonstrative)
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usually incubate the inoculum for a period beforehand to stabilize the material for testing. 

(RPFF ¶¶ 2192, 2785).94 The test articles are mixed with the inoculum in the test vessel and, for 

anaerobic testing, the vessels are flushed with gases like Nitrogen to eliminate most oxygen 

content that might remain. (RPFF ¶ 2425).95 Gas collection tubes are connected to the test 

vessel, and gas produced by the vessel is gathered and later measured. (RPFF ¶ 2645).96 The 

laboratory records the total amount of gas produced, and the ratios of methane gas to carbon 

dioxide. (RPFF ¶ 1915, 2202).97 A diagram of the typical ASTM D5511 gas evolution test is 

presented below: 

See RX 356, at 2 (ASTM D5511-12). 

 Results of the tests are based, in part, on the theoretical carbon yield for a test sample. 

(RPFF ¶¶ 1975, 2202, 2847, 2848).98 A sample can contain only so much carbon, and the 

amount of carbon in a sample can be calculated based on the molecular formulas for the substrate 

                                                             94 Id. 

95 See, e.g., RX 873 (Ullman, Dep. at 46). 

96 See RX 356, at 2 (D5511 test method, summary and apparatus). 

97 See CCX 84. 

98 See RX 864 (Barlaz, Dep. at 119–20). 

Figure 3. ASTM D5511 Setup (RX 356 at 2)
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plastic. (RPFF ¶¶ 1967–68).99 The gas evolution tests, like ASTM D5511, also test against 

negative controls, positive controls, and inoculum blanks. (RPFF ¶¶ 1913–14). As is relevant 

here, the negative control is often a copy of the test plastic without the additive technology. (See 

e.g., RPFF ¶¶ 2223, 2246).100 The inoculum blank is a test vessel that simply records gas 

production from the inoculum by itself. (RPFF ¶ 1933). The positive control is always 

cellulose, which is a rapidly biodegrading substance like filter paper. (RPFF ¶ 2127).101 The 

positive control serves only to indicate whether the test environment had sufficient life (e.g., 

fungi, microbes, bacteria, etc.) to adequately measure biodegradation. 102 The positive control is 

important because closed-system laboratory vessels are inhospitable to long-term testing. (RPFF 

¶ 2820).103 However, the positive control is not an indication of how the test article should 

perform comparatively.104 Biodegradation should be assessed relative to the negative control 

instead. (See e.g., RPFF ¶¶ 2544, 2567, 2591, 2593). 

 The laboratory can determine the level of gas attributable to the samples by subtracting 

the gas known to have been produced by the inoculum blank. (RPFF ¶ 2631).105 The inoculum 

contains living organisms that will emit gases while digesting other parts of the solid waste 

within the inoculum mixture.106 The laboratory can determine the proper gas level attributable to 

the test vessel by comparing the overall gas levels of the inoculum blank to those of the test 

article and negative control. (RPFF ¶ 2202–03).107

                                                             99 See RX 356, at 4 (§ 12). 

100 See, e.g., RX 860; RX 839; RX 836; RX 838. 

101 See RX 864 (Barlaz, Dep. at 17); RX 356, at 4 (§ 13). 

102 See RX 356, at 4 (§ 13.2); 

103 See RX 870 (Barber, Dep. at 125–127); RX 854, at 23 ¶ 64. 

104 See RX 854, at 24, 25 ¶ 74. 

105 See RX 356, at 4 (§ 12). 

106 Tolaymat, Tr. 300. 

107 See RX 356, at 4 (§ 12).
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 The laboratory calculates the percentage of biodegradation by comparing the level of gas 

attributable to the test sample with the theoretical maximum yield of gas from that same 

sample.108 In sum, because the gas emissions contain carbon, the test sample can only contain so 

much carbon, and the inoculum will produce only a certain amount of carbon. Based on those 

calculated limits, researchers can conclude that excess carbon recorded in the gas emissions 

represent a certain fraction of the carbon that had once been locked within the test article.109

 Gas evolution tests for biodegradation come in many iterations, but industry has 

consistently relied on variations of the ASTM D5511 standard because it is efficient and costeffective.110 In 1994, the ASTM first published the standard titled “Determining Anaerobic 

Biodegradation of Plastic Materials Under High-Solids Anaerobic-Digestion Conditions, ASTM 

D5511.” The purpose of the ASTM D5511 standard was to test for intrinsic anaerobic 

biodegradability of samples. (RPFF ¶ 1898). The D5511 test is designed to record data under 

accelerated conditions.111 Thus, the test calls for environmental conditions that hasten the 

appearance of measurable biodegradation effects.112 The temperature of the test is increased to 

around 52 degrees centigrade.113 The solids content is lowered to 20%, meaning the test is 

performed under rather wet conditions (80% moisture).114

                                                             108 Id. 

109 See, e.g., RX 864 (Barlaz, Dep. at 134–41). 

110 In fact, when measuring the anaerobic biodegradability of various plastics, one of 

Complaint Counsel’s proposed experts, Dr. Frederick Michel, also used an ASTM D5511 

protocol. Similarly, Complaint Counsel’s other experts, Dr. McCarthy and Dr. Tolaymat, have 

used gas evolution tests similar to the ASTM D5511 test to support claims of biodegradability 

for his bioplastic polymers. (RPFF ¶¶ 1546 (McCarthy), 2768 (Tolaymat), 2917 (Michel)). 

111 CCX 83. 

112 Id.. 

113 Id..

114 See RX 356; RX 855, at 41–49. 
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Landfill conditions are highly variable, and differ greatly from one landfill to the next, 

and even within each individual landfill. (RPFF ¶¶ 1582, 1640–43, 1713, 1723, 1815, 1851, 

1871–76).115 In any landfill, there are pockets that likely exhibit conditions similar to the D5511, 

but also pockets that may be considered less conducive to microbial or fungal life. (RPFF ¶¶ 

1644, 1781, 2807). The variable and unpredictable nature of landfills substantially limits the 

ability to predict with certainty how the D5511 test data would transfer into the natural 

environment. (RPFF ¶¶ 1582, 1640–43, 1713, 1723, 1815, 1851, 1871–76). However, scientists 

can and do predict that the mechanisms of action observed in the D5511 test also occur in the 

natural environment, including in landfills. (RPFF ¶ 2109–13).116

b. BMP Testing 

 Biomechanical Methane Potential (or “BMP”) testing is a gas evolution test that is 

designed to measure potential biodegradability of a test sample. The BMP test is performed in a 

liquid environment, with very high moisture content. (RPFF ¶¶ 1899–1905).117 BMP testing 

varies significantly from one laboratory to another. (RPFF ¶ 1901).118 In many instances, BMP 

testing calls for grinding the test product and screening it through a 1 mm screen. (RPFF ¶ 

1903).119 That process, if used with ECM’s products, would likely dissociate much of the ECM 

additive from the host plastic, thus nullifying the product’s efficacy. 

                                                             115 See RX 864 (Barlaz, Dep. at 38–40). 

116 See RX 854 (Burnette, Rep. at 26–27). 

117 See RX 864, at 73–75. 

118 See RX 851 (Tolaymat, Dep. at 146). 

119 See id., at 134. 
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 The ASTM D5511 test is comparable to the BMP test and the D5511 test presents 

conditions more like the natural environment. (RPFF ¶¶ 1907–08).120 Dr. Tolaymat agreed that 

the D5511 test is likely more representative of the landfill environment than the BMP test that 

Dr. Tolaymat himself used to test plastics for biodegradability in landfills. (RPFF ¶¶ 2756–58, 

2781). 

Dr. Barlaz, ECM’s expert witness, had performed several tests of ECM plastics including 

the ECM additive. He performed those tests prior to, and independent of, his role as an expert 

witness in this case. (RPFF ¶¶ 2626–2638). In at least one of those tests (RX 952), Dr. Barlaz 

obtained data showing that the plastic article had biodegraded substantially more than the 

amount reasonably attributed to the additive.121 Moreover, Dr. Barlaz observed that the gas 

production was consistent throughout the 60-day test window, indicating that when he stopped 

the test at 60 days the product had likely not finished biodegrading.122 

Drs. Sahu, Burnette, and Barlaz also testified that the presence of inconclusive tests does 

not nullify favorable tests, which clearly indicate that the ECM plastic has degraded. (RPFF ¶¶ 

2886–2908).123 A test may produce inconclusive results for many reasons that have nothing to 

do with the plastic substrate, not least of which is the death of the bacteria in the inoculum, a 

persistent problem. (RPFF ¶¶ 2890, 2894–96).124 In particular, variables in the manufacturing 

process could result in a product that lacks the ECM additive in substantial parts, or the test 

environment may not be conducive to the longer duration testing required. (RPFF ¶¶ 2905–06). 

The ECM additive can be “scorched” or burned during the manufacturing process, and that 

                                                             120 See, e.g., RX 851 (Tolaymat, Dep. at 138); RX 870 (Barber, Tr. at 101–02); RX 864 

(Barlaz, Dep. at 74–75). 

121 Barlaz, Tr. 2269-72; RX 952. 

122 Barlaz, Tr. 2269-72; RX 952. 

123 See, e.g., RX 864 (Barlaz, Dep. at 140–41). 

124 See RX 854 (Burnette, Rep. at 27 ¶ 82). 
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burning would render the additive ineffective. (RPFF ¶¶ 363, 758, 761, 1675, 1676, 1680). 

Similarly, the manufacturer’s inability to mix the ECM additive uniformly could result in plastics 

that actually lack the additive, or include it at lower amounts (or on the surface only). (RPFF ¶¶ 

337, 745, 752, 764, 1742–43). In addition, a lack of care in storage of the ECM additive 

resulting in the moisture protective seals being removed and the additive exposed to dry 

conditions can render the additive ineffectual. (RPFF ¶¶ 762–63). 

c. Qualitative Testing 

 ECM has produced qualitative testing that demonstrates the presence of biodegradation 

through qualities such as mass loss or gravimetric calculations. (RPFF ¶¶ 2660–2706). Dr. 

Timothy Barber is a renowned environmental scientist at Environ Corp.125 Environ is a global 

leader in environmental and human health testing. Dr. Timothy Barber is a principal working 

out of Environ’s Ohio group. (RPFF ¶ 104).126 He designed a test based on the conditions of an 

ASTM D5526 test that would measure biodegradation of test samples based on weight loss over 

time. (RPFF ¶¶ 2687–90).127 Dr. Barber testified credibly that the gas evolution tests had 

limitations when testing slowly degrading substances over long duration studies. (RPFF ¶ 

2672).128 His test results demonstrated that ECM’s additive would render plastics such as PVC 

                                                             125 See (Barber, Dep. at 246–61). 

126 See id. at 256–57. 

127 See, e.g., RX 573; CCX 791. 

128 See RX 870 (Barber, Dep. at 106) (“The measurement of carbon dioxide and methane 

are required under those test protocols are designed for relatively short periods of time. Because 

we needed to run these test out to 17, 23 months, we needed to use a protocol that did not require 

the capture and analysis of metabolic gases...”); Id. at 125–26 (“One of the challenges ... of 

trying to maintain an active microbial community in a static enclosure is how long you can 

maintain a functioning microbial community, and this was something in part of why we made 

modifications to some of the pre-existing ASTM protocols, because we knew we would have to 

run these tests 12 to 18 months”). 
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fully degradable with a 1.9 year half–life. (RPFF ¶ 2704).129 He confirmed his gravimetric 

endpoints by looking at free chloride content in the test solution, noting that the chloride ions 

would have come from the degraded sections of the PVC plastic. (RPFF ¶ 2670).130 Dr. Barber 

also reviewed test data from other laboratories concerning ECM’s additive technology.131 He 

was convinced based on the test results that ECM’s technology produced a biodegradable plastic. 

(RPFF ¶ 2685).132 He conveyed that opinion to ECM customers, stating expressly that ECM’s 

additive rendered plastics biodegradable. (RPFF ¶¶ 2700–02). 

 Dr. Barber also measured the presence of free chloride molecules in his BioPVC study. 

(RPFF ¶ 2695). He used the chloride ions to determine whether the biodegradation observed 

based on weight loss was a product of the source plastic degrading at the level of the carbon 

chain. (RPFF ¶ 2670). Drs. Sahu and Burnette both confirmed that the measurement of free 

chloride was a significant element, which adds further scientific confirmation that the ECM 

additive results in the biodegradation of the actual plastic by deconstructing the carbon chain. 

(RPFF ¶¶ 2662, 2670). 

 Other qualitative tests included electron microscopy performed of degraded ECM 

samples. Those tests revealed visual evidence of microbiological formation and attack on the 

ECM-treated plastics. (RPFF ¶ 2705).133 Several other laboratories have demonstrated ECM’s 

effects through qualitative evidence as well. ECM employees, including the inventor and the 

                                                             129 See RX 254, at 1 (“[t]he environmental half-life of bioPVC under aerobic conditions 

is estimated at 1.9 years”). 

130 See RX 370, at 6; RX 259 (“Certification of Results,” noting that “an increase in soil 

leachate chloride content and reduction in tensile strength was observed, indicated the PVC 

molecules were being effectively degraded”). 

131 See RX 269 (“ChemRisk” report). 

132 See, e.g., RX 870, at 90 (“the polyethylene film provided to me ... purportedly 

containing the ECM additive was determined to be biodegradable in our study”). 

133 See infra at 117 (table). 
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former owner of ECM, Mr. Riley, and the current president Mr. Sinclair and the Chief Financial 

Officer Mr. Sullivan, performed tests of the ECM additive in gardens, backyard soils, and in 50-

gallon drums to assess aerobic and anaerobic biodegradation in real-time. (RPFF ¶¶ 45–47, 51–

54, 2703).134 In most instances biodegradation was observed and, in the case of the tests by Mr. 

Riley, Mr. Sinclair, and Mr. Sullivan, complete biodegradation of the test plastic occurred within 

a 9 month to 5 year interval. (RPFF ¶¶ 49, 54). 

d. Radiolabeling Tests Are Not Required 

 At the outset, radiolabeled carbon-14 testing is not a unique testing method, as it involves 

the same type of gas evolution testing that ECM had run, and that Complaint Counsel’s experts 

had run, to assess biodegradability. (RPFF ¶¶ 1790–91, 1953). The radiolabeled carbon-14 test 

is simply a “marker” test, whereby the test is able to more accurately record biodegradation of 

test samples when the amount of biodegradation is perceived to be very small. (RPFF ¶¶ 1954–

55). Dr. Barlaz testified, by contrast, that when the amount of biodegradation in the test vessel is 

substantial, as it was in many ECM tests, the conclusion that the test plastic is biodegrading can 

be clearly established without the need for carbon-14 testing. (RPFF ¶ 1955). 

 In fact, no expert who testified in this case has ever run a carbon-14 radiolabeled test of 

plastic polymers to assess biodegradation. (RPFF ¶¶ 1612, 1617, 1767, 1771, 1773). ECM’s 

experts along with Dr. Tolaymat testified that radiolabeled testing is unnecessary and not the 

industry standard. (RPFF ¶¶ 1771, 1774, 1776–1809, 1952–1963). Dr. Sahu had investigated 

whether radiolabeled testing was possible for the ECM product. (RPFF ¶ 1778). He discovered 

that it was not, and, while test sites are available to run the actual tests, he was unable to readily 

                                                             134 See CCX 818, at 63–69; CCX 820, at 8–9. 
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find a manufacturer that would synthesize the proper polymer with the carbon-14 marker. (RPFF 

¶ 1779). 

Complaint Counsel’s rebuttal expert casually included an “estimate” for carbon-14 

testing, ostensibly to suggest that such testing was possible. (RPFF ¶ 3002). But Dr. Michel 

included no supporting documentation concerning that estimate or its applicability in the context 

of polymer testing. (RPFF ¶ 3002). His estimate was clearly a hypothesis based on lab time, 

without any consideration of the practicalities of that testing in the context of plastic polymers. 

(RPFF ¶ 3002). Significantly, Dr. Michel has never performed a carbon-14 test on plastic 

polymers and, so, his estimate does not mention or address the difficulties mentioned in detail by 

ECM’s witnesses. (RPFF ¶ 2922). Dr. Michel also recommended the use of a company that 

produces radiolabeled material, and that company, American Radiolabeled Chemicals, was 

shown through Dr. Barlaz to have improperly labeled radioactive material in prior projects. 

(RPFF 1959–1962). 

Complaint Counsel’s experts have suggested that ECM should have performed 14C 

radiolabeling tests to demonstrate that the plastic itself degrades during the gas evolution tests.135 

Complaint Counsel’s reliance on 14C radiolabeling tests is misplaced for several reasons. First, 

the test is entirely impractical, and no one runs it. (RPFF ¶¶ 1775, 1963). Not even Complaint 

Counsel’s expert, Dr. McCarthy, who competes against ECM in the market, has performed 14C 

testing on his technology (yet it is he who describes it as definitive in his expert report). (RPFF ¶ 

1767).136 Radiolabeling is very expensive and difficult to perform. (RPFF ¶ 1774).137 ECM 

would need to find a plastics manufacturer capable of manufacturing a radiolabeled polymer 

                                                             135 See, e.g., CCX 891, at ¶ 891. 

136 See RX 841 (McCarthy, Dep. at 90); RX 362. 

137 See RX 853 (Barlaz, Rep. at 9); RX 855 (Sahu, Rep. at 47–48). 
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with the ECM additive included in such a way that the 14C content does not mix with the 

additive. (RPFF 1778–79, 1789).138 Many laboratories can perform 14C testing if given a 

suitable sample, but few if any companies are willing to prepare the radioactive plastic sample 

for eventual testing.139 Because 14C is a radioactive isotope, the manufacture would need to 

operate under strict radioactive hazard containment conditions, and undertake massive burdens to 

decontaminate their facility following production. (RPFF 1893–94).140 The costs associated 

with that form of testing are extreme; Complaint Counsel has not been able to produce a single 

example of a competitor using 14C testing to support biodegradation claims, although there are 

many competing companies selling biodegradable technologies. 

 Furthermore, even assuming that 14C testing was feasible, the ultimate test of the plastic 

must still be performed for biodegradation. That test would still be a gas evolution test similar or 

identical to the D5511 test. (RPFF ¶¶ 1790–91, 1953).141 So the insistence on 14C testing 

actually contradicts Complaint Counsel’s central theory of this case, which is that gas evolution 

studies do not simulate or replicate the landfill environment. Radiolabeled testing is just one 

kind of gas evolution study, run under similar conditions as the tests now in the record. If 

Complaint Counsel’s concern is that ASTM D5511 tests do not simulate landfills, then the 

radiolabeling test does not alleviate those concerns. Put simply, the kind of testing needed to 

provide Complaint Counsel what it considers competent and reliable scientific evidence of 

plastics biodegradation does not exist. 

                                                             138 See RX 842 (Sahu, Dep. at 113–16). 

139 See Id. (explaining that ECM had attempted to obtain prices for radiolabeling testing 

but was unable to find manufacturers capable or willing to manufacture the radioactive 

components for testing). 

140 See id., at 116–23. 

141 See id., at 321–22 (expressing concerns that Complaint Counsel had not seemed to 

appreciate that radiolabeled products must still undergo gas evolution testing, like ASTM D5511 

testing, to test for biodegradability). 
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 Dr. Barlaz testified that the only advantage to carbon-14 testing comes where the 

laboratory is measuring “minute” amounts of biodegradation. (RPFF ¶ 1954). According to Dr. 

Barlaz, where the laboratory is measuring substantial amounts of methane and carbon dioxide, 

the carbon-14 test does not “buy[] you anything.” (RPFF ¶1955). Dr. Barlaz confirmed Dr. 

Sahu’s testimony, and explained that it would be hard to find someone who could make the 

properly radiolabeled plastic for testing. (RPFF ¶ 1958). He testified that carbon-14 testing is 

not generally accepted in the relevant scientific community as necessary to show biodegradation 

of materials. (RPFF ¶ 1963). 

 Dr. McCarthy attempted to dismiss positive ECM test results because, according to Dr. 

McCarthy, they cannot show whether crystalline or recalcitrant sections of the polymer had 

degraded. (RPFF ¶ 1460). Dr. McCarthy’s reliance on carbon-14 testing as a solution is 

erroneous for at least three reasons: 

 First, Dr. McCarthy has himself used straight gas evolution testing, not carbon-14 testing, 

to conclude that a plastic which degrades less than 50% (in some cases less than 15%) is 

completely biodegradable. (RPFF ¶¶ 1453, 1498, 1507, 1509). Dr. McCarthy makes no mention 

of his crystallinity theory when it comes to his own testing of his own products.142

 Second, Complaint Counsel offered no evidence showing that the carbon-14 testing 

would even address Dr. McCarthy’s concerns and, in fact, it would not. Dr. Barlaz testified that 

when you have a polymer that consists of more than one compound, the researcher must carbon14 label the molecule precisely where you want it, and that is very difficult to accomplish. 

(RPFF ¶ 1956). Dr. Sahu explained that the formation of amorphous v. crystalline sections of a 

                                                             142 See, e.g., RX 928; RX 940; RX 942. 
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polymer is unpredictable, variable, and subject to the manufacturing process.143 Thus, a 

manufacturer would carbon-14 label a polymer not knowing whether the radiolabeled sections 

are within amorphous or crystalline regions, defeating Dr. McCarthy’s premise altogether. 

(RPFF ¶ 1800). Complaint Counsel has provided no specific evidence on how this type of 

testing would be accomplished to overcome those concerns. 

 Finally, Dr. McCarthy’s entire theory of amorphous v. crystalline regions is contradicted 

by the scientific evidence. Unsurprisingly, Dr. McCarthy made no attempt to explain what 

percentage of a thermoplastic polymer might be “amorphous” vs. “crystalline.”144 He testified 

erroneously that amorphous and crystalline regions do not overlap but are separate and distinct 

within a plastic and conveyed the equally erroneous notion that crystalline regions are 

impenetrable such that carbon chains within them could not be broken by enzymatic activity of 

microbes.145 That theory was rejected based on commonly accepted biochemistry (a field in 

which McCarthy admitted he is not expert, RPFF ¶ 1355)) in the testimony of ECM’s expert Dr. 

Sahu.146 Dr. McCarthy, self-admittedly not a chemist (RPFF ¶ 1355), testified that “the polymer 

has a crystalline region and an amorphous region...”147 McCarthy never explained that 

“thermoplastic” polymers of the kind manufactured by ECM customers (e.g., LLDPE bags) are 

amorphous or at most semi-crystalline. (RPFF ¶¶ 1554–55). In any event, McCarthy’s theory of 

the impenetrability of crystalline regions and of their complete segregation of the amorphous was 

refuted based on generally accepted biochemistry in Dr. Sahu’s testimony when Dr. Sahu 

                                                             143 Sahu, Tr. 1797–1800. 

144 McCarthy, Tr. 359–690. 

145 McCarthy, Tr. 618–620. 

146 Sahu, Tr. 1797–1800. 

147 McCarthy, Tr. 477. 
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explained that “crystalline portions and amorphous portions randomly occur[] within each other 

in the same article.”148

E. ECM Possesses a Reasonable Basis, and at Least Competent and Reliable 

Scientific Evidence, that the ECM Additive Causes Plastics to Biodegrade in 

Landfills 

The Pfizer factors demonstrate that biodegradable claims need not meet a high standard 

of competent and reliable evidence. The FTC has the burden of showing that a particular claim 

was made without a reasonable basis. See FTC v. Braswell, 2005 WL 4227194 (C.D. Cal. Sept. 

27, 2005); F.T.C. v. Medlab, Inc., 615 F. Supp. 2d 1068, 1079 (N.D. Cal. 2009); FTC v. Pantron 

I Corp., 33 F.3d 1088, 1096 (9th Cir.1994). In order to have a reasonable basis to make the 

claim at issue, an advertiser must possess “competent and reliable scientific evidence” to 

substantiate that claim. Sterling Drug, Inc. v. FTC, 741 F.2d 1146, 1156–57 (9th Cir.1984). To 

help determine what constitutes “competent and reliable scientific evidence,” the FTC has 

recognized two types of claims: establishment and non-establishment claims. See Thompson 

Med. Co., Inc. v. F.T.C., 791 F.2d 189, 194 (D.C. Cir. 1986). Establishment claims contain 

express or implied representations about the level of support for a particular claim (i.e., the claim 

states that a product has been found to be superior by scientific tests). Id. For such claims, the 

advertiser must possess the level of proof claimed in the ad. Id. 

In contrast, a non-establishment claim is a simple claim of efficacy. Id. For such nonestablishment claims, “the reasonable basis inquiry has been defined more flexibly.” Id. This 

standard is a “flexible standard” that calls for an evaluation of a variety of factors suited to the 

particular case at hand. Direct Mktg. Concepts, Inc. v. F.T.C., 581 F. Supp. 2d 115, 118 (D. 

                                                             148 Sahu, Tr. 1800. 
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Mass. 2008). Therefore, the Commission’s “reasonable basis cases have identified several 

factors that [the Commission] will weigh in determining the appropriate level of substantiation 

for objective advertising claims.” In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648, at 

¶ 70 (Nov. 23, 1984). The relevant factors are: “(1) the product involved; (2) the type of claim; 

(3) the benefits of a truthful claim; (4) the ease of developing substantiation for the claim; (5) the 

consequences of a false claim; and 6) the amount of substantiation experts in the field would 

agree is reasonable.” Id. These factors are used to weigh the benefits and costs of developing 

substantiation for the claim. In the Matter of POM Wonderful LLC, 2013 WL 268926, at *30 

(F.T.C. Jan. 16, 2013).149

The level of proof required to meet the Pfizer test in this case is significantly reduced 

because all of the Pfizer factors favor a more relaxed standard. 

1. The Products Involved Do Not Affect Consumer Health or Safety, or the 

Performance of the Products While Used by Consumers 

Regarding the first factor, the product involved, the Commission has made clear that 

products like drugs—which improve physical welfare—as opposed to products that to those not 

claimed to have drug effects, “require[] a relatively high level of substantiation.” Thompson, 104 

F.T.C. 648, at ¶¶ 71–72; see also POM, 2013 WL 268926, at *48 (noting that the respondents 

“made claims regarding serious diseases”); In the Matter of Removatron Int’l Corp., 111 F.T.C. 

206, at *14 at n. 20 (Nov. 4, 1988) (noting that a drug or product that directly affects human 

safety requires more substantiation). 

                                                             149 ECM has not made any “establishment” claims to end-consumers. To ECM’s 

sophisticated manufacturing customers, it has disclosed the types of tests shown to have resulted 

in biodegradation. To the extent ECM’s disclosure of its test data and names of test standards is 

an establishment claim, the claim is truthful and non-misleading. ECM does possess the tests its 

claims to have, and those tests do show that ECM’s technology creates a biodegradable plastic. 
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ECM does not market products like drugs, foods, medical devices, or dietary 

supplements; it sole product is designed to cause plastics to biodegrade more rapidly than 

plastics not containing the ECM additive. (RPFF ¶ 40). ECM has not made any claims that its 

product effects human or animal health; it has made no claims concerning serious diseases or 

health conditions. Moreover, significantly, ECM has never sold product to end-consumers. 

(RPFF ¶ 389). ECM sells a plastic additive to plastics manufacturers that, when manufactured 

correctly, will help render the finished plastic biodegradable in a landfill over time. 

The intended use of ECM’s product is of relevance only after end use consumers have 

discarded it in customary disposal. Whatever benefit is achievable through ECM’s product 

comes after the customer or user has relegated the product for disposal. ECM’s product has no 

performance benefit or utility to consumers at the time of purchase or during their productive use 

of it. For this reason, Dr. Mort Barlaz credibly testified that the actual product performance in a 

landfill environment was almost irrelevant to a consumer. When discussing rates of degradation, 

he explained: 

I estimate a half-life of three years and the actual half-life is six years or oneand-a-half years, it’s inconsequential for the performance of the landfill. 

Either way there is biodegradation occurring because the material is in the 

landfill, in essence, forever. That’s what I mean by infinite retention time. 

Whether we are off a few years in either direction, it doesn’t really seem to 

matter.150

So, too, here, where the question involves the nature of the product, an item advertised only for 

its benefit after customers throw it away should be subject to much less scrutiny than other 

products that have a chance to hurt or harm consumers during use. 

                                                             150 CCX 943 (Barlaz, Dep. at 109–110). 
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2. The Type Of Claims Made Are General Efficacy Claims that Are 

Subjective 

The second factor is the type of claim being made. One type of claim that requires a high 

a level of substantiation “is a claim that refers to specific facts or figures, rather than making 

generalized descriptions of the product’s capabilities.” Thompson, 104 F.T.C. 648, at ¶ 72. 

Therefore, a generalized claim, such as “biodegradable,” would require a lower level of 

substantiation than a more specific claim. 

ECM’s claims presented to sophisticated manufacturing corporations conveyed the 

simple point that ECM plastics were “biodegradable” within a reasonably short period of time. 

Those corporations only considered material to a purchase the fact of biodegradation, not rate, 

which fact they themselves discerned upon independent confirmatory testing. (RPFF ¶¶ 605–

725). Such claims are thus of little consequence to purchases made based on a customer’s own 

independent evaluation and are, at most, general efficacy claims, and should be regarded as 

nothing more under the Pfizer analysis. 

3. The Benefits of a Truthful Claim and Ease of Developing Substantiation 

for the Claims 

The third and fourth factors are often considered “in conjunction with each other.” 

Thompson, 104 F.T.C. 648, at ¶ 74. The Commission’s “concern in analyzing these factors is to 

ensure that the level of substantiation [the Commission] require[s] is not likely to prevent 

consumers from being told potentially valuable information about product characteristics.” Id.; 

see also Removatron, 111 F.T.C. 206 at n. 20 (“These two factors together seek to ensure that the 

level of substantiation we require is not likely to deter product development or prevent 

consumers from being told potentially valuable information about product characteristics”). 
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Consumers can be prevented from being told potentially valuable information about product 

characteristics when the cost of developing substantiation for these claims would be high in 

comparison to the amount of sales the product can earn. Id. at ¶¶ 74–75. So, the Commission 

will not require substantiation that, because of its probative costs, will become infeasible. POM, 

2013 WL 268926, at *49. 

ECM’s product provides an environmentally-friendly alternative to conventional plastics. 

Unlike companies selling compostable technologies, or more expensive bioplastics, ECM’s 

technology lives within the reality that the bulk of waste is deposited in landfills. While waste 

reduction and alternative processing techniques are laudable, they are in the minority today. 

Moreover, because financial considerations are always paramount to ongoing businesses, most 

companies are unable to undertake the extreme costs associated with emergency technologies 

like bioplastics. ECM offers a middle ground alternative, permitting companies to improve the 

environment in the long-term without incurring substantial increases to their cost bases. The 

ECM additive works, and it reduces the environment lifespan of many conventional plastics by a 

very substantial margin. 

Because the technology works, many manufacturers gain access to a commercially viable 

solution that might encourage more plastics manufacturers to choose environmentally-friendly 

upgrades over conventional plastics used today. 

Imposition of strict, and unobtainable standards here will chill innovation and prevent 

plastic manufacturers’ access to valuable information concerning products that biodegrade in a 

progressive manner, over time. A product that biodegrades over a period of decades is not 

irrelevant in the market simply because it will not degrade within one year. ECM and its 

customer base have taken steps to evaluate biodegradability through laboratory testing and a 
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fully informed industry has chosen to buy the ECM products cognizant of the test results 

showing that it causes biodegradation of plastics and not dependent upon proof of any particular 

rate of that biodegradation. (RPFF ¶ 355). Moreover, the testimonial evidence reveals 

biodegradation that is slow and progressive actually inures to the benefit of the environment and 

to all life on earth because it reduces greenhouse gas emissions deleterious to the environment 

and opposed by national environmental policy set by the EPA. (RPFF ¶¶ 1593–1605). 

Complaint Counsel’s experts have failed to identify any generally accepted and 

practicable alternative form of biodegradability testing to the gas evolution testing performed on 

ECM additive containing plastics. Dr. McCarthy’s statements, however, are revealing. Dr. 

McCarthy wrote that a “study must last long enough for the sample to reach at least 60% 

biodegradation” in a D5511 context. (CCX 891 (McCarthy, Rep. at 15–16)). That, of course, 

contradicts Complaint Counsel’s argument which depends on proof of 100% biodegradation. 

(RPFF ¶¶ 1455, 1462, 1540). According to Dr. McCarthy, companies can also perform 14C 

radiolabeling tests. (CCX 891 (McCarthy, Rep. at 15–16)). In the end, both of Dr. McCarthy’s 

requirements are excessive and impractical, and not even McCarthy uses them in his own 

original scientific research or patent. (RPFF ¶¶ 1542–50). Rather, in his own work outside of 

his testimony to the Court, Dr. McCarthy accepts as little as 14% biodegradation over 45 days to 

support a conclusion that the plastic is biodegradable. (RPFF ¶ 1547). 

First, because ECM’s product slowly degrades when compared to more rapidly degrading 

items like cellulose, the ECM product would need to perform very long-term testing to reach the 

60% value. For instance, in one ECM test of a polyethylene polymer, the test revealed about 

50% biodegradation over 900 days of testing. (RPFF ¶¶ 2456–2476; RX 836). Extensive testing 
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is expensive and, obviously, time consuming and, given the inherent vulnerabilities of death of 

the bacteria in the inocula, very difficult to maintain. 

Note, also, that Dr. McCarthy would require test conditions that mirror the landfill sites 

(e.g., temperature, moisture content, etc.). McCarthy is actually proposing that a company come 

as close to an in situ landfill study as possible. What if a product results in biodegradation in a 

landfill in 25 years? When compared with a conventional plastic that takes thousands of years to 

biodegrade, that 25 year span is a substantial benefit but it would not be within the arbitrary and 

capricious one year limit advocated by Complaint Counsel and ensconced as an effective rule in 

the Green Guides. However, under McCarthy’s strict criteria, he would need testing of at least 

15 years duration before those products could hit the market.151 Most pharmaceutical cancer 

drugs are tested and approved in half that time.152 

In the meantime, consumers would be purchasing and using conventional plastics without 

the additive, having been deprived of predictable biodegrading benefits, predictable based on 

accelerated gas evolution tests. (RPFF ¶¶ 338–39). Some degree of accelerated testing is 

necessary, therefore, in the real world. That accelerated testing includes generally accepted 

protocols like the D5511 test, which ECM customers ran repeatedly with positive results. (RPFF 

¶¶ 1619–21, 1804–08). The D5511 testing, and similar gas evolution testing, provides a 

reasonable basis for biodegradability claims as the scientific literature in this field reflects, and 

ECM possesses that requisite level of proof. 

                                                             151 See also Tolaymat, Tr. 245-50 (suggesting, without scientific support, that a company 

may need to test a product for 20 years to make a biodegradable claim). 

152 See Frequently Asked Questions, The University of Arizona Cancer Center, m 

azcc.arizona.edu (“[m]any standard treatments used today are the result of past clinical trials, 

which involve a strict and rigorous, multi-step process that takes eight years on average to 

complete.”), at http://azcc.arizona.edu/patients/clinical-trials/faq (last visited Sep. 25, 2014). 
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Dr. McCarthy also posits that 14C radiolabeling should be required. That level of testing 

is impractical, excessively costly, and largely unavailable. (RPFF ¶¶ 1775–1800, 1952–1963 

(Barlaz)). Dr. McCarthy himself has labeled products “biodegradable” without resort to 

radiolabeling testing. ECM’s experts each agree (and apparently also one of Complaint 

Counsel’s experts, Dr. Tolaymat, based on his testimony in deposition)153 that radiolabeling tests 

are not required to prove the type of claims at issue here. 

4. The Consequences of a False Claim are Negligible and Complaint 

Counsel has Provided No Record Evidence Suggesting that any 

Consumer Could Have Been Harmed Through a False Claim 

Under the fifth factor, the consequences of a false claim can be divided into either health 

or economic consequences. See Thompson, 104 F.T.C. 648, at ¶¶75–76 (noting that false claims 

can be “injurious to health and economically harmful”). In order to be economically harmful, 

the economic harm suffered by consumers must be “material” and “substantial.” See POM, 2013 

WL 268926, at *50, n. 31 (noting that a one year supply of the POM Juice costs at least $780); 

Removatron, 111 F.T.C. 206 at n. 20 (noting that the device at issue cost approximately $4,000, 

and required treatments that cost $35 per hour over a period of years). 

Here the consequences of a false claim are not demonstrated in the record. Complaint 

Counsel has offered no proof of any consumer harm, which is understandable given that the 

product benefit of biodegradation occurs after a consumer has permanently discarded, or thrown 

away, the plastic, i.e., after the consumer has finished his or her productive use of the plastic. 

Assuming, for this factor only, that ECM’s product was ineffective, the consequences of a false 

claim would not be material or significant to anyone. Complaint Counsel has not offered 

                                                             153 Dr. Tolaymat testified that radiolabeling was not used frequently because it “could be 

as expensive as doing [testing] in a landfill.” See Tolaymat Tr. at 246-47. 
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evidence of an environmental detriment. Landfill operators are not designing landfills, or 

making waste management decisions, on the basis of whether ECM additive containing plastics 

biodegrade within one year or a hundred. Plastic products treated with ECM additive are 

disposed of in the normal course, along with other non-degradable plastics. As Dr. Barlaz 

testified, because the intended use is for infinite retention in the landfill, a false or misleading 

claim has no material consequence. (RPFF ¶¶ 1593–94; Barlaz, Tr. 2283–84). Whether the 

product performs precisely as advertised in the landfill is impossible to confirm in the real world 

because of the inherent variability of disposal conditions. 

Dr. Barlaz testified that materials which degrade slowly over time in landfills are far 

better for the environment than fast degrading materials that may produce methane before the 

landfill operators are prepared to harvest landfill gases. (Barlaz, Tr. 2280–84). The result of that 

fast degrading product would be a net contribution to methane gas emissions. (Barlaz, Tr. 2280–

90). Thus, according to Dr. Barlaz’s well-supported testimony, if ECM’s biodegradable claims 

are false, then there is no environmental detriment, injury, or harm caused by the landfilling of 

the ECM products. (Barlaz, Tr. 2280–90). In other words, a product that degrades fast has a 

higher global warming potential than slowly degrading products (or those that do not degrade at 

all). (Barlaz, Tr. 2286–90). 

Moreover, if the product does not biodegrade rapidly (e.g., rate), the end consumer never 

discovers that fact and experiences no consequential injury of any kind. That is in 

contradistinction with other commercial products, whereby the consumer suffers direct loss or 

injury during use of the product. The purchasers or consumers here are the corporate entities that 

infuse their plastics with ECM’s product in commerce. There is no evidence that those 

companies sell ECM plastics to end-consumers for the biodegradable performance of the plastic; 
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indeed, most products containing the ECM additive are invisible in that respect to the end-use 

consumer or, if identified as biodegradable, as Dr. Stewart’s survey confirms, are not understood 

to mean anything in particular by consumers. (RPFF ¶¶ 1105–1344). Even if we assume ECM’s 

product does not perform as well as advertised, none of ECM’s customers have been denied the 

economic benefit of a bargained for transaction; to the contrary, they receive the plastic they seek 

and it performs as they expect it; after they discard of it, it retains no value to them and, so, they 

are not harmed if it fails to biodegrade by any set rate in a landfill. 

That point notwithstanding, ECM has always indicated to its direct customers that the 

period for biodegradation is highly variable and depends on environmental factors. (RPFF ¶¶ 

309–12, 320, 377–78, 1352). ECM’s customers reasonably understood, therefore, that 

biodegradation could occur over significant periods of time. Those customers have even tested 

ECM’s product and reviewed ECM’s scientific literature. Customers purchasing the ECM 

additive for altruistic environmental reasons had the information necessary to assess ECM’s 

claims, and suffered no economic injury as they made claims based on that information. 

5. The Competent and Reliable Scientific Evidence Proves that ECM’s 

Additive Renders Conventional Thermoplastics “Biodegradable” 

More than thirty individual tests from multiple laboratories show plastics made with 

ECM’s additive will biodegrade in various environments, including MSW landfills. (RPFF ¶¶ 

2129–2706). ECM’s test data (including the inconclusive test results) reveal that Complaint 

Counsel’s criticisms are unfounded or unsupported. Here we address the various levels of proof 

ECM supplied proving that its additive technology renders non-degradable plastics 

“biodegradable” in landfill conditions. We will then address each of the scientific criticisms 

upon which Complaint Counsel erroneously rely to condemn ECM’s product. 
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When compared with conventional plastics, plastics manufactured with ECM’s additive 

degrade over varying lengths of time in MSW landfills. ECM has consistently explained to its 

customers that the ECM additive is “not a poof and it’s gone” technology.154 The test data and 

peer-reviewed literature demonstrate that ECM plastics will, in fact, biodegrade where untreated 

plastics will not. (RPFF ¶¶ 1964–2009, 2129–2706). Complaint Counsel posits a number of 

criticisms without the benefit of testing or peer reviewed literature in support, but ultimately their 

position distills to the following points not supported by the scientific evidence: (a) that ECM’s 

accelerated testing has not shown that ECM’s technology causes the conventional plastic to 

become biodegradable in a landfill environment because the tests do not precisely mirror 

conditions in a landfill, (b) no test has been run long enough to show complete degradation of a 

plastic containing an ECM additive; and (c) the results of ECM’s positive tests are attributable to 

factors other than plastics biodegrading.155 Given the many tests favoring ECM, and the 

overwhelming weight of the scientific evidence on both the mechanism of action present and the 

proof of biodegradation in a wide range of plastics, those positions are scientifically invalid and 

contradicted by the totality of the scientific evidence. 

The crux of Complaint Counsel’s position is that test data revealing amounts of 

biodegradation less than cellulose, a very rapidly degrading substance, are irrelevant because 

ECM cannot extrapolate test results beyond the four corners of each test report. However, ECM 

has shown through peer-reviewed literature, expert testimony, and test data that the relative 

amounts of biodegradation observed in ECM tests are quite substantial when compared to non-

                                                             154 See, e.g., RX 680 (“It’s not a ‘poof it’s gone’ system but simply makes the plastic 

product biodegradable as if it were a stick or a branch off a tree rather than ‘sticking around’ for 

hundreds of years.”); RX 371, at 4 (same); RPFF ¶ 378. 

155 See, e.g., RX 865 (Complaint Counsel stating to another regulated entity that “we have 

serious concerns about these additives and whether they work at all,” and later explaining that 

the additive companies “would have to shut down and close [their] doors”). 
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degrading conventional plastics and are generally accepted by experts as predictive of 

biodegradation of plastics in landfill environments (even consistent with Dr. McCarthy’s own 

extrapolation methodology undergirding his ‘199 patent for “biodegradable” plastic 

polymers).156 ECM has established through test data and other scientific evidence that products 

manufactured with ECM’s additive will continue biodegrading to completion in the landfill 

environment. (RPFF ¶¶ 1621, 1891–1898). 

The following representative tests have shown that plastics manufactured with ECM’s 

technology biodegrade significantly: 

Test Year Method Duration Plastic/ECM % Biodeg. 

McLaren/Hart 

(RX 269)157 1999 

Scientific Evaluation and 

Review of existing study data 

(anaerobic/aerobic report) 

15 days 

22 months 

ECM Pellet 

5% ECM Film 

24% (pellet) 

Qualitative 

evidence of 

biodegradation 

(film) 

Univ. of NM 

Electron 

Microscopy 

2006 

Scanning Electron Microscope 

(SEM) images of treated test 

samples 

n/a Treated 

bubblewrap 

Qualitative 

evidence of 

biodegradation 

Univ. of NM 

Electron 

Microscopy 

2007 

Scanning Electron Microscope 

(SEM) images of treated test 

samples 

n/a Treated PS 

foam 

Qualitative 

evidence of 

biodegradation 

SSCCP 

(RX 465) 2009 

UNI EN 14043/2003,158

aerobic159 degradation test of 

Italcom product 

91 days 

PET 

PVC 

Film 

4.95% (PET)160

50.09% (PVC) 

4.80 (Film) 

                                                             156 See RX 362. 

157 Respondent/Complaint Counsel Exhibit Nos. RX 269, CCX 266E, CCX 268A. 

158 Some of the SSCCP tests involved the grinding of test samples in liquid nitrogen to 

obtain particles with sizes of <1 mm. The grinding process, which could separate the additive 

components from the plastic, is likely to significantly reduce, if not nullify, any expected 

biodegradable effect achieved through biofilm formation and quorum effects. 

159 Aerobic tests are relevant to prove the mechanism of action and intrinsic 

biodegradability of ECM plastics. 

160 Averages of three datasets recorded. 
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Test Year Method Duration Plastic/ECM % Biodeg. 

SSCCP 

(RX 467) 2013 ISO 14855, UNI EN 14046, aerobic degradation ,Colplast 91 days Unknown 11.9% 

SSCCP 

(RX 468) 2013 ISO 14855, UNI EN 14046, aerobic degradation, Colplast 91 days Unknown 6.96% 

Ecologia 

Applicata s.r.l. 

(RX 273) 

2010 UNI EN ISO 14855, aerobic 

degradation, for Co.ind. s.c. 180 days PP/1% 19.3% 

Sondor 

(RX 274) 2011 Sondor Biofoam degradation test 775 days Various/2% 

Qualitative 

evidence of 

biodegradation 

(mass loss, etc.) 

Environ 

(RX 275) 2012 

Environ PS & PE testing for FP 

International (modeled after 

ASTM D5338 & D5511) 

120 days PS & PE/1% >5% 

Ecologia 

Applicata s.r.l. 

(RX 276) 

2011 UNI EN ISO 14855, aerobic 

degradation, for Colplast S.r.l. 180 days 

Polyammide & 

Nylon/% 

unknown 

46.67% 

Intertek India 

(RX 277) 2012 

D5511, ISOE Printpack 

Industries, PVT, LTD, sample 

sheet 

45 days Sample sheet 

unknown 

Qualitative 

evidence of 

biodegradation; 

gas data; no 

negative control 

Clemson Univ. 

Study 

(RX 388-91) 

2009 

In situ testing of various treated 

samples for Dispozo Products 

Inc. 

477 days EcoPure 

Qualitative 

evidence of 

biodegradation 

Case Western 

(RX 278) n/a Prof. Morton Litt SEM Examination of ECM plastic in n/a/ n/a/ 

Qualitative 

evidence of 

biodegradation 

Eden 092511B 

(RX 248) 2011 ASTM D5511, for FP International 120 days Airbag film/1% 

11.5% 

15.2% 

Eden 070312C 

(RX 839) 2012 ASTM D5511, for Shields Bag & Printing 22 weeks Film/1% 7.9% 

Eden Fellows 

(RX 403) 2012 ASTM D5511 for Fellows 197 days Amended film/1%161

71.8% 

16.1% 

                                                             161 The Fellows product was treated with additional biodegradable elements. 
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Test Year Method Duration Plastic/ECM % Biodeg. 

Eden FPI 

(RX 402) 2014 Updated ASTM D5511 standard for FP International 290 days 

1% ECM film 

1.75% ECM 

film 

5.5% 

11.5% 

Eden FPI 

(CCX 548) 2013 Modified ASTM D5511 for FPI EPS Samples 291 days Expanded PS/1% 30.4% 

Eden Smithers 

(RX 401) 2013 ASTM D5511 for Smithers Oasis 148 days Foam/1.1% Foam/3% 

2.4% 

5.8% 

Eden FPI 

(CCX 546) 2011 ASTM D5511 for FP International 977 days 

Air bag 

(TKN)/1% 

Air bag 

(HOP)/1% 

36.7% 

39.8% 

Environ 

(RX 254) 2008 Anaerobic study based on ASTM D5526 180 days Amended PVC 2.7% (based on gravimetric data) 

NE Labs 

N0843980 

(RX 399) 

2008 ASTM D5511 study for BioTec Environmental LLLC 14 days PP Sheet 8.4% (based on 

gravimetric data) 

NE Labs 

N0946510-01 

(RX 398) 

2009 ASTM D5511 study for 

Masternet Ltd. 15 days PE/1% 4.91% 

NE Labs 

1048742-01 

(RX 405) 

2010 ASTM D5511 study for Eco 

SmartPlastics 45 days LDPE/1.5% 7.37% 

NE Labs 

1048819 

(RX 396) 

2010 ASTM D5511 study for Eco 

SmartPlastics 43 days PET 7.01% 

NE Labs 

1150851 

(RX 395) 

2011 ASTM D5511 study for Sweet 

Tape Enterprise (M) Sdn. Bhd. 45 days PP 4.54% 

NE Labs 

1150851 

(RX 394) 

2011 ASTM D5511 study for 

Tycoplas Sdn Bhd 15 days PS foam 5.89% 

NE Labs 

1253020 

(RX 393) 

2012 ASTM D5511 study for 

National Tree Co. 15 days PVC PE 

9.89% 

5.75% 

NE Labs 

1048036 

(RX 392) 

2011 ASTM D5511 study for 

Transilwrap Co. 233 days Film Laminate 

7.85% 

8.53% 
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Test Year Method Duration Plastic/ECM % Biodeg. 

NE Labs 

N1048340 

(RX 836) 

2013 ASTM D5511 study for Pregis 

(PPC) 900 days PE Poly Bags/1% 49.28% 

OWS PFR-1 

(RX 263) 1998 

Aerobic Biodegradation under 

controlled composting 

conditions (ISO 14855) 

45 days 

5% film 

5% natural 

film 

4.5% 

2.6% 

OWS PFR-4 

(RX 265) 1999 High Solids Anaerobic Digestion (HSAD) concept test 15 days ECM pellet 24.0% 

OWS PFR-5 

(RX 266) 2000 

Aerobic Biodegradation Under 

Controlled Composting 

Conditions (40 Gal Trash Bag) 

45 days Treated bag 5.2% 

OWS BFI-1 

(RX 268) 2010 

High Solids Anaerobic 

Digestion (HSAD) Test for 

Covidien 

15 days PP 3.9% 

Eden 

MicroTek 

(CCX 534) 

2011 ASTM D5511 test for 

MicroTek 811 days PE 17.9% 

Eden EcoLab 

(CCX 547) 2013 ASTM D5511 test for EcoLab 452 days Film 19.6% 46.5% 

NE Labs 

1149980 

(RX 838) 

2011 ASTM D5511 & D6579 tests 

for Minigrip 365 days LDPE/LLDPE/1.5% 17.07% 

NE Labs 

1048215 

(RX 863) 

2010 ASTM D5511 test for Dansko 15 days Rubber/2.5% 1.5%162

a. Testing of the ECM Additive Confirms that It Accelerates the 

Biodegradation Process 

Dr. Barlaz reviewed many of the gas evolution studies involving the ECM amended 

plastics. (Barlaz, Tr. 2247). He examined the raw data produced by Northeast Laboratories and 

                                                             162 The unconventional use of the ECM additive in a rubber polymer produced a 

degradation rate of 1.5% (which was less than the percentage of the additive), which supports the 

reliability of the Northeast Labs results by demonstrating that tests results have been varied. 
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Eden Laboratories, particularly the data concerning methane generation from the test substrate 

and methane generation from the inoculum that would be the background methane. (Barlaz, Tr. 

2247–48). For those tests where Dr. Barlaz had triplicate data (e.g., raw data), Dr. Barlaz 

performed statistical analyses, including T-tests, to determine whether there were statistically 

significant differences between the methane generation in the reactor with test substrate and the 

methane attributable to the inoculum alone. (Barlaz, Tr. 2248). 

For other studies where triplicate data was not available, Dr. Barlaz examined the ratios 

of methane generation in the test material plus inoculum to methane generation from the 

inoculum only. (Barlaz, Tr. 2248). Dr. Barlaz concluded for those studies that ratios varied, but 

the ratios were generally significant even at the lower end. (Barlaz, Tr. 2248–49). From those 

ratios, Dr. Barlaz determined that the methane generation in the test vessels could be attributable 

to the test substrate, which suggests that the substrate was undergoing anaerobic biodegradation 

and conversion to methane. (Barlaz, Tr. 2249, 2260–62). Dr. Barlaz prepared a spreadsheet of 

his statistical calculations. (Barlaz, Tr. 2250; RX 472). Dr. Barlaz had also updated his 

spreadsheet to include additional calculations based on the data. (Barlaz, Tr. 2251; RX 968). 

To address the question of whether only the ECM additive had biodegraded, Dr. Barlaz 

estimated the amount of methane that could theoretically be produced by the ECM additive 

alone. (Barlaz, Tr. 2251–53). Dr. Barlaz made certain conservative assumptions about the ECM 

additive when calculating the amount of potential methane. (Barlaz, Tr. 2252–53). Dr. Barlaz’s 

conservative calculation was that one gram of ECM additive would produce 933 mL of methane 

gas. (Barlaz, Tr. 2253). Based on that calculation of 933 mL, Dr. Barlaz looked at the methane 

yields in the test vessels during biodegradation testing, and determined that the amount of 

biodegradation exceeded the amount that could potentially be sourced from the additive. 
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(Barlaz, Tr. 2253–54). Dr. Barlaz’s calculation of the potential methane yield of the ECM 

additive is likely conservative because of the assumptions he made. (Barlaz, Tr. 2254). Dr. 

Barlaz assumed the additive was 50% carbon. (Barlaz, Tr. 2254). Polyethylene, by contrast, is 

almost 90% carbon. (Barlaz, Tr. 2254). 

Dr. Barlaz also calculated the methane yield of the ECM additive based on the formula 

for the ECM additive that Dr. McCarthy used in his expert report at page 24, footnote 17 of his 

report, which was said to be the result of reverse engineering of the ECM product. (Barlaz, Tr. 

2254–55; CCX 891 at 24 n.17). Based on Dr. McCarthy’s assumptions about the ECM 

additive’s contents, Dr. Barlaz calculated a methane yield for the ECM additive of 838 mL per 

gram. (Barlaz, Tr. 2255; RX 968). Using Dr. McCarthy’s assumptions, the data produced in the 

gas evolution tests suggests that even more of the substrate plastic (not the additive) biodegraded 

because the ECM additive would have had a lower potential methane yield. (Barlaz, Tr. 2255–

56). Using the Minigrips NE Lab study as an example (RX 838), Dr. Barlaz explained the 

arithmetic summarized in his spreadsheet. (Barlaz, Tr. 2256–57; RX 968). Dr. Barlaz calculates 

the weight of the ECM additive (in grams) by multiplying the percentage of the ECM additive 

load rating (in the Minigrips test, 1.5%) by the starting weight of the entire test plastic. (Barlaz, 

Tr. 2256–57). Because Dr. Barlaz has calculated the amount of total methane potential from one 

gram of ECM additive, he can then determine the total amount of methane possible in the ECM 

additive in each specific test by multiplying the actual weight of the ECM additive by the 

conservative 933 mL calculation (or 838 mL if using Dr. McCarthy’s assumptions). (Barlaz, Tr. 

2256–58). His calculation of the ECM additive methane potential is set forth below, using a 

1.5% load rating as an example: 

 (25 g Plastic Sample) x 1.5% (ECM Additive) = 0.375g (the weight of the ECM 

Additive) 
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 (933 mL CH4/gm ECM additive) x (0.375g ECM additive) = 349.875 mL total 

CH4 possible from ECM Additive 

 3,837.3 mL of net CH4 (subtracting out inoculum) – 349.875 mL CH4 from ECM 

= 3,487.425 mL CH4 (which came from the test plastic). 

(RPFF ¶¶ 1973–1988). 

Dr. Barlaz also calculated the net methane for each test vessel, which he did by 

subtracting the mean triplicate methane data from the inoculum blanks from the test vessels. 

(Barlaz, Tr. 2257–58; RX 968 (Summary Sheet)). For those studies where Dr. Barlaz had raw 

data, he calculated T-tests. (Barlaz, Tr. 2257). The T-statistic is the most common statistical test 

after a calculation of the average. (Barlaz, Tr. 2259). Dr. Barlaz also calculated standard 

deviations for tests where he had triplicate data, however the T-test is superior in that it also 

takes into consideration the elements of standard deviation. (Barlaz, Tr. 2264). Dr. Barlaz 

looked for a 95% certainty in the statistics that he ran, which would mean that the researchers are 

95% “certain that you got the right answer.” (Barlaz, Tr. 2260). Dr. Barlaz’s t-statistics were 

generally well below the .05 that indicates statistical significance at the 95% level. (Barlaz, Tr. 

2257). Dr. Barlaz’s mathematical process is explained in his testimony. (Barlaz, Tr. 2257–59). 

Dr. Barlaz explained that where the methane produced from the test vessel is not attributable to 

the inoculum, and not attributable to the ECM additive, then the biodegradation must come from 

the plastic substrate itself. (Barlaz, Tr. 2258). Dr. Barlaz’s calculations are also conservative 

because “it’s not proven” that the ECM additive would completely biodegrade on its own while 

locked within the plastic without also having the plastic biodegrade along with the additive. 

(Barlaz, Tr. 2258). Dr. Barlaz also analyzed the ratios of methane to carbon dioxide in the lab 

tests. (Barlaz, Tr. 2261–62). A ratio of methane to carbon dioxide that is greater than 1:1 
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respectively is a good indication that the anaerobic environment was behaving properly. (Barlaz, 

Tr. 2262–63). Gas evolution testing also does not account for carbon that may have been 

cleaved from the substrate but converted to cell mass instead of gas. (Barlaz, Tr. 2263–64). 

Therefore, the biodegradation numbers calculated by the laboratories based on gas data alone are 

a lower limit of the carbon conversion than was actually realized. (Barlaz, Tr. 2263–64). 

Based on his statistical analyses and the test data he reviewed concerning ECM amended 

plastics, Dr. Barlaz testified that competent and reliable scientific evidence confirms that plastics 

manufactured with the ECM additive are anaerobically biodegradable. (Barlaz, Tr. 2264–65). 

Dr. Barlaz testified that “[b]ased on checking of the lab reports, there were numerous examples 

where specific plastics were shown to anaerobically biodegrade to methane.” (Barlaz, Tr. 2175). 

Stated differently, the test data clearly proves that, for many tests, the test plastic biodegraded far 

in excess of the biodegradation that could have possibly been due to degradation of the ECM 

additive alone, even assuming that the microbes could have completely digested the additive first 

(a scientific non sequitur because the additive when properly manufactured is evenly mixed 

throughout the plastic). 

Significantly, the Northeast Labs test results were confirmed through other standards, 

including the ASTM D6579, which is a standard for calculating molecular weight averages and 

molecular weight distribution in the test sample vs. the negative control. (RX 838). The NE 

Lab’s Minigrips test (RX 838) had reported approximately 17% biodegradation of the test 

sample after 365 days of testing. (RX 838). The test sample consisted of LLDPE plastic bags 

with a 1.5% ECM additive. (RX 838). In its August 1, 2012 Analytical Report (RX 838), NE 

Labs demonstrated that the plastic “zip bags” treated with the 1% ECM additive had a molecular 

weight that was approximately 16% less than the untreated test sample. (RX 838 at 73 (8/1/2012 
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Report)). Both the “number average” and the “weight average” molecular weights of the 1.5% 

ECM treated plastic had declined by about 16%, as measured using a different ASTM standard, 

ASTM D6579. (RX 838 at 73 (8/1/2012 Report)). NE Labs reported in its analysis that the 

“change in molecular weight is measure of bulk deterioration.” (RX 838 at 73 (8/1/2012 

Report)). Thus, the molecular weight testing under ASTM D6579 confirmed the gas evolution 

endpoint, which Dr. Barlaz had already determined was (a) statistically significant and (b) was 

clear, competent, and reliable evidence that the plastic and not the additive was biodegrading. 

(RX 968). 

A large majority of the ECM tests reveal positive evidence of biodegradation in excess of 

what can be attributed to the additive alone. (RPFF ¶¶ 2129–2706). Moreover, not every NE 

Labs test showed evidence of substantial biodegradation. In 2010, the NE Labs testing for 

Dansko on rubber shoe parts produced evidence of 1.5% biodegradation in 15 days of testing, at 

an ECM load rating of 2.5%, undermining any claim that NE Labs testing is always positive. 

(RX 863). 

Although the data was available to Complaint Counsel’s experts just as it was for ECM’s 

experts, none of Complaint Counsel’s experts performed the expected expert task of statistical 

analyses of the data at issue in this case. (RPFF ¶¶ 2449, 2454–55, 2853–57, 2999). They did 

not perform the calculation that Dr. Barlaz performed concerning the methane potential of the 

ECM additive, even though Complaint Counsel’s witnesses agreed that it would be scientifically 

logical to do so. (RPFF ¶¶ 2449, 2454–55, 2853–57, 2999). 

 
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b. Complaint Counsel’s Criticisms of ECM’s Testing are Theoretical and 

Lack Empirical Support 

 Despite the overwhelming evidence of ECM’s additive causing plastics to biodegrade, 

Complaint Counsel presents a variety of theories, including ones that are inconsistent with one 

another, in an effort to discredit the entire body of scientific evidence. None of those theories, 

taken alone or in combination, overcome the totality of the evidence showing that ECM’s 

additive, when properly blended within major plastic resins (e.g., PP, PS, and PE), will produce a 

biodegradable plastic that biodegrades in landfills. In short, Complaint Counsel would have the 

Administrative Law Judge rule that each of the dozens of independent, positive ECM tests is 

flawed to the point of irrelevance, and that the ALJ should construe inconclusive tests to be what 

they are not, negative tests proving the additive ineffectual, in order to credit Complaint 

Counsel’s theory of the case. Consider the following arguments crucial to Complaint Counsel’s 

position: 

i. ECM’s testing conditions adequately simulate or replicate landfill 

settings 

There are no practical tests that precisely simulate or replicate all landfill conditions, and 

Complaint Counsel has offered no such method through its experts, but tests showing that one or 

more common bacteria in a closed test environment do biodegrade plastic and are generally 

accepted as predictive of biodegradation in landfills where far greater numbers and kinds of 

biodegrading bacteria and fungi are present. (RX-756 at 6–12; RX-853 at 7–9; RX-865 at 41–

47). Dr. Barlaz testified that attempting to “simulate” precisely a landfill environment might 

require testing that spans 100 years. (Barlaz, Tr. 2212). He explained that “it’s not practical to 

try to simulate that kind of ecosystem at the time scale in the laboratory.” (Barlaz, Tr. 2212). 
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Dr. Sahu agreed that accelerated testing was the generally accepted means to measure 

biodegradability, essentially a time accelerated microcosm of part of the landfill environment. 

(Sahu, Tr. 1924). Although Complaint Counsel’s witnesses repeatedly stressed the need to 

“simulate” precisely a landfill, they provided no evidence or example of a test that would 

actually achieve that measure of simulation. (RPFF ¶ 1619). With the high variability of landfill 

conditions, it would be impossible to truly simulate the natural environment. (RPFF ¶¶ 1618–23, 

1885). 

According to Complaint Counsel, no test can actually simulate or replicate the landfill 

environment and, so, every test must be rejected. That position is contrary to the generally 

accepted scientific evidence which routinely extrapolates from closed system tests to the landfill 

environment. (RPFF ¶¶ 1620–21). The flawed nature of that argument is most apparent when 

considering that Complaint Counsel’s own experts relied on the same testing methodologies as 

ECM to prove that products were biodegradable in the landfill environment. For instance, Dr. 

Frederick Michel performed an ASTM D5511 to assess whether seven plastics would be 

considered anaerobically biodegradable in the environment. (RPFF ¶¶ 1609–1611, 1616). Dr. 

McCarthy, Complaint Counsel’s lead scientific witness, performed similar gas evolution studies 

to determine that his own technology was aerobically and anaerobically biodegradable. (RPFF ¶ 

1611; RX 756). Dr. Tolaymat, Complaint Counsel’s landfill expert, testified that a BMP test 

should be used to measure biodegradability, which is a gas evolution test arguably less 

representative of a landfill than the D5511 standard. (RPFF ¶¶ 2721, 2751-2761). 

 In short, Complaint Counsel has failed to identity a single test or analysis that it 

concludes is generally accepted evidence of biodegradation in a landfill other than the gas 

evolution tests actually performed on the ECM additive containing plastics. Therefore, their 
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theory appears to be that no such claim could ever be substantiated based on what the scientific 

community accepts, which is a false premise built on a constitutionally infirm preference for 

blanket censorship. 

ii. Microbes Are Capable of Biodegrading Conventional Plastics 

 

Complaint Counsel argues that extrapolation of data from the D5511 test environment 

into the landfill is scientifically inappropriate because (1) the test environment does not simulate 

or replicate the landfills; and (2) several studies involving ECM plastic appear to “plateau.” 

ECM expert Dr. Ryan Burnette, a microbiologist with expertise in anaerobic microbiology, 

testified that landfills (and most environments) have been shown to contain an assortment of 

microbiological life, and that biodegrading microorganisms present in the D5511 laboratory 

environments are a subset of those present in landfills. (RPFF ¶¶ 2038–2128; RX 854 at 6–14). 

He and Dr. Sahu testified that microorganisms have been shown to degrade polymers through 

processes such as enzymatic digestion, and that microorganisms responsible for biodegradation 

in laboratory environments thrive and metabolize matter in landfill settings. (RPFF ¶¶ 1629–

1670, 2038–2128). 

Moreover, Dr. Burnette explained that the so-called “plateau” effect (wherein evidence of 

biodegradation levels off during testing) is likely the result of limitations of the close-system lab 

test. (RPFF ¶¶ 2076–2093). The lab environment is a closed, finite system that prevents 

microbial growth and succession, like a fish tank that is never cleaned or emptied. Thus, it is not 

accurate to describe the conditions of a D5511 test as “optimal” in long term tests. (RPFF ¶ 

2118). For instance, feedback inhibition occurs much more rapidly (and is permanent) in a 

laboratory environment, whereas in the natural environment the flow of liquid and the settlement 
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of materials would be expected to disperse or diffuse levels of enzymes and byproducts that limit 

cellular metabolism. (RPFF ¶¶ 2082–2086). 

Finally, in some instances, the evidence suggests that the testing conditions to begin with 

were never adequate to support biodegradability testing. For instance, in at least several of the 

tests that did not show biodegradation of plastics said to be infused with the ECM additive, the 

positive control (cellulose) plateaued prematurely along with the test article.163 That is what 

happened with Complaint Counsel rebuttal expert Dr. Frederick Michel’s test, albeit other 

methodological problems also plague his testing.164 Because cellulose is well-established to 

completely mineralize and biodegrade, the plateau is a sure sign of death of microbial life in the 

test environment.165

ECM’s additive permits the biodegradability of otherwise non-biodegradable plastics by 

(1) facilitating the breakdown of plastic polymers into smaller chains suitable for enzymatic 

digestion and (2) fostering the formation of biofilms at or around the plastic, which, in turn, 

weaken and break the carbon bonds in polymers through enzymatic and acidic digestive 

processes. (RPFF ¶ 1722; RX 855, at 27–29). ECM’s expert, Dr. Ranajit Sahu, is an expert in 

environmental and applied sciences. (RPFF ¶¶ 151–179). He has over twenty years of 

experience in environmental, mechanical, and chemical engineering, much of which includes 

work related to landfills and materials used in landfill construction (e.g., plastic polymers). 

(RPFF ¶ 164; see also RX 842 (Sahu, Rep. at 26–32)). He explains that the peer-reviewed 

literature and testing data shows plastics to be biodegradable in time, and that the ECM additive 

acts to exponentially increase the rate of biodegradation. (RPFF ¶¶ 1629-1765). 

                                                             163 See id. at ¶ 33; RX 755, at 4. 

164 Id. 

165 See RX 870 (Barber, Dep. at 153–54). 
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Dr. Sahu explained that bacteria can achieve initial adherence to plastics via weak 

interactions, such as hydrophobic, van der Waals, temperature, and other variable interactions. 

(RPFF ¶¶ 1658–61; RX 854, at 14). All plastics contain these weak points, but the ECM 

additive multiples the weak points for invasion by diffusing the biodegradable additive 

throughout the plastic. (RPFF ¶¶ 1726–27). Biofilms have been shown to grow and accumulate 

on substrates, including plastics, for purposes of degradation, arising at these points of weakness 

in the plastic. (RPFF ¶¶ 1724–27). Studies in the peer-reviewed literature have documented that 

bacteria and fungi are able to use natural and synthetic plastics as food sources. (RPFF ¶¶ 1728–

1731). Much research has been dedicated to the ability of microbes to degrade plastics such as 

Polyethylene (PE).166 Anaerobic bacteria in landfills (and present in the laboratory tests) release 

enzymes that have the ability to weaken and eventually break carbon bonds. (RPFF ¶¶ 2042–

2074). The breakage of carbon bonds results in the destruction of plastic polymers which are 

capable of retaining their integrity as plastic only if carbon bonds remain intact. (RPFF ¶¶ 2094–

2098). 

iii. Complaint Counsel’s Theory that Biodegradation Does Not Occur 

in Landfills Is Scientifically Erroneous 

Dr. Morton Barlaz is Professor and Head of the Department of Civil, Construction, and 

Environmental Engineering at North Carolina State University. (RPFF ¶¶ 182–200). He has a 

B.S. in chemical engineering and an M.S. and Ph.D. in Civil and Environmental Engineering. 

(RPFF ¶¶ 182–200; RX 853, at Exh. 3 (Barlaz, M., Curriculum Vitae)). His M.S. and Ph.D. 

research focused on biodegradation in landfills. Complaint Counsel’s witness, Dr. Tolaymat, 

recognizes Dr. Barlaz as an authority in the area of biodegradation. (RPFF ¶¶ 2724–2727). Dr. 

                                                             166 Id. at 18 (citing, e.g., Phanerochaete chrysosoporium, Rhodococcus rubber, A. oryzae, 

Brevibacillus borstelensis, Penicillum simplicissim YK). 
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Barlaz testified that Dr. Tolaymat’s view of landfill science was flawed and anachronistic. Dr. 

Barlaz explained that landfills are characterized by their biological activity and are not, as Dr. 

Tolaymat describes them, “dry tombs.” As Dr. Barlaz testified, most U.S. landfills produce a 

substantial amount of methane and carbon dioxide gas—directly resulting from biological 

activity in the form of biodegradation. (RPFF ¶¶ 1846-1849, 2877–2885). 

Thus, Complaint Counsel misleads by characterizing modern landfills as “dry tombs” 

wherein little or no biodegradation can occur. Landfills do indeed permit biodegradation in 

substantial quantities. (RPFF ¶¶ 1846–1849, 2877–2885). 

Landfills are also characterized, however, by their environmental diversity. (RPFF ¶¶ 

1640–43, 1851). The moisture content, temperature, density, and composition of MSW landfills 

change constantly, differ substantially from one landfill to another, and differ significantly from 

one cell in a landfill to another in the same landfill. (RPFF ¶¶ 1640–43, 1851). There is also 

variability in the actual time required before the microbiological system becomes established for 

anaerobic biodegradation following waste disposal. (RX 853, at 6). 

That high degree of variability makes difficult any exact prediction of the time for 

biodegradation. (RPFF ¶¶ 1640–44). Nonetheless, Dr. Barlaz explains that gas evolution tests 

(such as the ASTM D5511) are useful and accepted as indicative of a substance’s ability to 

biodegrade anaerobically, albeit not as a test of rate of biodegradation. (RPFF ¶ 1627). 

Moreover, if a product is shown to degrade anaerobically in a test environment, then it is also 

likely to biodegrade in a landfill, but perhaps at a slower rate. Thus, the dichotomy between the 

landfill and the test environment relates to the speed with which biodegradation occurs, not 

whether biodegradation occurs at all. (RPFF ¶¶ 1922; RX 853, at 7–8). 
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Landfills are responsible for mostly anaerobic degradation, but also a limited amount of 

aerobic degradation. For instance, the emission of carbon dioxide gases from landfills around 

the country indicates the presence of oxygen, which can be trapped within the landfill or released 

during the degradation of other MSW components. (RPFF ¶ 1842). 

Dr. Barlaz has also assessed many of the scientific studies for which the parties possessed 

raw data. (RPFF ¶ 1965). Moreover, Dr. Barlaz explained that outside the context of this 

litigation he actually visited Eden Laboratories to review the sufficiency of that lab’s test 

methods and facilities, finding the lab well and properly run. (RPFF ¶¶ 221–16). Dr. Barlaz 

explained that the positive tests in the record before this Court are indicative of biodegradation in 

excess of the ECM additive (contrary to Dr. McCarthy’s “priming effect” theory). (RPFF ¶ 

1969; RX 864 (Barlaz, Dep. at 175–76)). He explained that “reactor tests” of the kind ECM 

presents provide “results on what is possible in a landfill given appropriate environmental 

conditions.” (RX 853 (Barlaz, Rep. at 8)). 

Complaint Counsel’s purported expert in landfills, Dr. Thabet Tolaymat, lacks the 

education, experience, or training sufficient to opine on the issues central to this case. (RPFF ¶¶ 

2707–2885). Dr. Tolaymat admittedly lacks an understanding of the microbiology and bacterial 

communities at work in the landfills or test environments. (RPFF ¶¶ 2796–2803; RX 851 

(Tolaymat, Dep. at 225–26)). Although he testified as an “employee of the federal government,” 

his antiquated opinions concerning “dry tomb” landfills are inconsistent with the EPA’s 

regulation of those landfills and the EPA’s statutory goals, not to mention the testimony of a man 

he identified as an authority, Dr. Morton Barlaz. (RPFF ¶¶ 2707–16, 2724–27, 2877–85). Dr. 

Tolaymat prepared his expert report, which may have far-reaching consequences for 

environmental policy, without consulting anyone expert in the areas he is not at the U.S. EPA. 
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(RPFF ¶¶ 2711–16). Not a single EPA employee or representative reviewed Dr. Tolaymat’s 

work product to determine if his views were consistent with those of that agency. (RPFF ¶¶ 

2711–16). Dr. Barlaz testified that Dr. Tolaymat’s report is erroneous on certain fundamental 

points concerning landfills, landfill management, and biodegradation testing. 

Dr. Barlaz testified that Dr. Tolaymat’s report is erroneous on certain fundamental points 

concerning landfills, landfill management, and biodegradation testing. For example, Dr. Barlaz 

explained that Dr. Tolaymat’s opinion was misleading because Dr. Tolaymat suggested that 

biodegradation only occurs in bioreactor landfills, and Dr. Tolaymat also adopted a very narrow 

definition of bioreactor landfill. (RPFF ¶ 1852). Dr. Barlaz testified that the term “dry tomb 

landfill” is misused because the implication of the term and the implication of Dr. Tolaymat’s 

report was that if a landfill is not actively adding moisture to a landfill, then it is a dry tomb 

landfill, which is false. (RPFF ¶ 1855). Dr. Barlaz “strongly disagree[d]” with Dr. Tolaymat’s 

opinion that in situ landfill testing was important to document the anaerobic biodegradability of a 

material. (RPFF ¶ 1394). Dr. Barlaz also explained that Dr. Tolaymat had referenced lysimeter 

testing that Dr. Barlaz himself performed with Chris Bareither at the University of Wisconsin 

and had incorrectly implied that Dr. Barlaz and Chris Bareither had measured methane 

generation in the lysimeter test when in fact they did not measure methane generation at all. 

(RPFF ¶¶ 1936–37). Lastly, Dr. Barlaz found Dr. Tolaymat’s suggested use of lysimeter studies 

to be unscientific because it would be extremely difficult to gather useable, representative 

biodegradability data from a large lysimeter design. (RPFF ¶ 1950). 
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iv. The Positive Laboratory Tests do not Have Fatal Methodological 

Flaws 

 Complaint Counsel failed to produce any evidence concerning why the methodology of 

ECM’s gas evolution studies was flawed.167 Although Complaint Counsel’s witnesses dismissed 

the tests as inadequate, they did so largely without explanation and in no instance did they 

provide an empirical analysis explaining precisely what made any test result invalid. (See, e.g., 

RPFF ¶¶ 2443–44). By contrast, ECM experts testified in detail why they viewed the test results 

revealing biodegradation of test plastics caused by the ECM additive to be consistent with 

generally accepted scientific principles and practices for determining biodegradation. (See, e.g.. 

RPFF ¶¶ 1967–1971, 2541). 

Complaint Counsel, through argument of counsel, previously identified a series of socalled methodological “flaws” to justify its categorical rejection of the over 33 tests showing the 

ECM additive causes biodegradation. Significantly, almost all of those “flawed” tests employed 

suitable negative controls. (See e.g., RPFF ¶¶ 2197, 2223, 2226, 2246, 2249, 2265, 2269, 2290, 

2294, 2309, 2327, 2351, 2368, 2424, 2426, 2459, 2461, 2465, 2480, 2486, 2509, 2526, 2536, 

2552, 2561, 2583, 2587, 2595, 2605, 2618). ECM experts explained that the use of negative 

controls in those tests mitigated Complaint Counsel’s perceived issues in the methodology, as 

explained below.168

                                                             167 Tr. 1–3005; CCX 0–1108. 

168 Sahu, Tr. 1921; Barlaz, Tr. 2246; Complaint Counsel also refers to their own “welldocumented studies” conducted by laboratories like O.W.S. and North Carolina State University. 

See CC Pretrial Br. at 37. However Complaint Counsel is unclear what they mean by “welldocumented.” Unlike many of ECM’s studies, those studies to which Complaint Counsel 

referenced were not accompanied by raw data. Most of them included just final reports or 

results. Complaint Counsel apparently thinks that the conclusory data is of more quality despite 

the absence of methods simply because the reports were inconclusive. 
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 For example, Complaint Counsel contends that tests did not maintain anaerobic 

conditions throughout the test. That is incorrect. In certain situations, laboratories (e.g., 

Northeast Labs) would “re-innoculate” the test vessel with fresh inoculum. The labs reinoculated specifically to test the theory that a plateau effect indicated that the test article had 

finished degrading. NE Labs would flush the vessels with Nitrogen after adding inoculum, 

which effectively purges the system of oxygen and restores immediately the anaerobic 

environment. Dr. Sahu testified that the reinoculation process was not a concern in long term 

D5511 studies. (RPFF ¶ 2541). 

 Complaint Counsel’s theories on “leakage” in the system are entirely theoretical. There 

is no evidence in the record that any of the ECM test vessels leaked. For instance, Alan Johnson 

at NE Labs testified that it would be immediately apparent if a leak arose in the system because 

the graduated cylinder would not be able to maintain proper pressure and the water levels would 

fall. (RPFF ¶ 2409). There is no evidence of that in any of the tests. Complaint Counsel also 

suggested that small leaks could factor in the testing results. That point is misleading for at least 

two reasons. First, the test vessels have a positive pressure, which is why they emit gas that can 

be collected.169 If there was a “small” leak in the system, the leakage would be pushing gas out 

of the container and not permitting atmospheric gases into the container. Second, and relatedly, 

a “small” leak would only serve to diminish the results of a positive test because methane gas 

that would otherwise be collected and used to calculate the percentage of biodegradation would 

have been lost through the leak. If Complaint Counsel’s point was to suggest that a leak 

introduces oxygen, than that point is also without merit because all experts agree that the 

presence of methane is exclusive to anaerobic systems, and oxygen would destroy anaerobic 

                                                             169 McCarthy, Tr. 300. 
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bacteria. (See, e.g., RPFF ¶¶ 1718, 1810, 1840, 2059 In all of the positive anaerobic ECM tests, 

the labs and ECM’s experts calculated the percentage of biodegradation largely through the 

methane content in the test samples. (RPFF ¶¶ 2180–2659). 

 For several tests where ECM received the raw datasets, Dr. Barlaz completed statistical 

analyses to determine standard deviations, t-tests, ratios, and other relevant calculations to test 

the sufficiency of the data. (RPFF ¶¶ 1967–70). Based on the raw data provided, Dr. Barlaz 

determined that the tests revealed that methane generation from the test materials was 

significantly (p<0.05) greater than what could be attributed to the inoculum. (RPFF ¶ 1967).170 

Moreover, based on calculations of the theoretical carbon yield from ECM’s additive (by 

weight), the tests reveal that significantly more carbon would have come from the test article 

than what could reasonably have been supplied by the ECM additive. (RPFF ¶ 1969). In other 

words, the plastic substrate had biodegraded. (See, e.g., RPFF ¶ 2469). 

 Complaint Counsel claims that tests were not run for periods of time validated under the 

methodology. Again, that criticism is invalid, considering that the methodologies are unsuited to 

measure slowly degrading substances. In addition, the method itself does not specify an actual 

time period for the test, and actually contemplates that the test will be run longer as necessary. 

(RPFF ¶ 2484). 

 Dr. Barlaz has visited Eden Laboratories and reviewed their testing operations. (RPFF ¶ 

2211). He also reviewed NE Lab’s protocols and testimony. (RPFF ¶¶ 2213, 2215, 2430). Dr. 

Barlaz found no reason to doubt the validity or reliability of the data from either laboratory. 

(RPFF ¶ 2216). 

                                                             170 See RX 853, at 14. 
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v. The Limited Number of Inconclusive Tests Do Not Rise to the Level 

of Evidence that ECM’s Product Is Inefficacious 

 Complaint Counsel selectively relies on a lesser number of tests said to have shown no 

biodegradation of plastics infused with the ECM additive. Those tests are in the minority and are 

mischaracterized by Complaint Counsel to be negative. They are, in point of fact, inconclusive, 

because not in a single one has there been evaluative testing thereafter to establish the true cause 

of test failure and there are many potential reasons for failure. Either the actual cause must be 

proven or all other potential causes ruled out before one could conclude that the ECM additive 

did not render the plastic infused with it biodegradable. Among the many potential causes not 

ruled out in any of these tests are death of the bacteria in the inoculum, mis-manufacture of the 

plastic containing the ECM additive, and the presence of anti-bacterial additives in the plastic. 

(RPFF ¶¶ 760–66). Complaint Counsel’s argument also reveals hypocrisy and inconsistency. 

First, the tests were conducted under largely the same conditions and protocols as the positive 

tests upon which ECM relies.171 It is disingenuous to argue that ECM’s favorable tests are 

worthless because they are flawed methodologically or do not simulate the landfill environment, 

but then embrace the inconclusive tests simply because the outcome better fits Complaint 

Counsel’s theory of the case. 

 Second, those tests that reported zero or negative biodegradation totals are highly suspect. 

For context, Complaint Counsel has argued that favorable results in ECM testing are owed to 

something called the “priming effect.” As used by Complaint Counsel, the “priming effect” 

allegedly occurs when the inoculum gears up to digest the ECM additive, which, as Complaint 

Counsel concedes, is composed of biodegradable material. We address the flaws in the priming 

                                                             171 Dr. Michel conducted his “peer-reviewed” study under a protocol similar to ASTM 

D5511. (RPFF ¶ 2917). 
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effect theory below. The crucial point, however, is that the ECM additive is biodegradable. Any 

legitimate test should therefore show a statistically higher rate of biodegradation in the test 

sample to account for the degradable nature of the ECM additive. If the test shows zero or event 

negative degradation, then questions immediately arise as to (1) the manufacturing quality of the 

test sample; (2) the inclusion of the additive in the test article uniformly (as ECM requires); or 

(3) the viability of the laboratory environment. For instance, on that latter point, several of the 

inconclusive tests Complaint Counsel rely upon showed that the positive control (cellulose) 

stopped degrading prematurely and plateaued. Cellulose is indisputably biodegradable, so the 

plateau is a true indication that the test was inadequate (the microbial life apparently ceased 

biological activity or died). Such is true of the Michel test, for example. (RPFF ¶ 2987). Closed 

systems have inherent limitations that might skew data. While those variables may not be to 

blame in every instance of inconclusive test data, evidence of improper testing conditions should 

be ascribed the proper weight.172 Moreover, in systems dependent on a subset of microbial life 

to sustain them, the delicate nature of that life invites inconclusive tests because maintaining that 

life in a closed environment is difficult. (RPFF ¶¶ 2043, 2680–81). 

 One of the more considerable issues is the manufacture of the ECM product, which must 

be done correctly to keep the additive efficacious. The inconclusive tests do not include chain of 

custody data sufficient to prove that, indeed, the ECM additive was properly infused into the test 

plastic in strict accordance ECM manufacturing instructions. (See, e.g., RPFF ¶¶ 2939–2944). 

                                                             172 For example, a fish tank is also a closed ecological system. Imagine a fish tank that 

was never cleaned or cared for. Over a short period of time, that closed system would develop 

feedback inhibition conditions (e.g., accumulation of waste bi-products) that would render 

certain processes or life untenable. Those similar limiting factors would not be expected in an 

environment open to the cleansing force of elements, like the ocean or a landfill in active use. 
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vi. The Priming Effect Is an Unproven Myth 

 Complaint Counsel’s experts have tried to diminish ECM’s positive test data by arguing 

that any reported biodegradation is owed to a supposed “priming effect.” They argue, also, that 

the small amounts of biodegradation reported in ECM’s studies are insignificant and should be 

disregarded. Although unclear from Complaint Counsel’s presentation, their experts appear to 

argue that the degradation reported in ECM’s favorable tests is a result of the inoculum 

increasing metabolic activity when exposed to the ECM additive. Dr. Barlaz has testified that 

the concept of “priming effect” has not been seen in anaerobic systems and is invalid in relation 

to tests on the ECM product. (RPFF ¶¶ 2020, 2024). 

The major flaw in that theory is that it depends on the idea that the biodegradation 

recorded is solely attributed to the additive, or catalyzed by the additive. The test data upon 

which ECM relies show amounts of degradation far in excess of the amount of additive present 

in the test plastic. (RPFF ¶¶ 2180–2659). Thus, if the theory is that the inoculum is triggered by 

the ECM additive, then Complaint Counsel fail to explain why the amounts of degradation 

continue beyond the amount fairly attributed to the additive (e.g., 1% degradation). Moreover, 

Complaint Counsel’s theory presupposes that all of the ECM additive is available to the biota at 

the start of the test, which is untrue. The ECM additive is uniformly mixed throughout the 

plastic and, so, only a small percentage of the additive is immediately available for consumption 

at the outset. (RPFF ¶¶ 745, 764, 1742–43). The biota may opportunistically find the additive or 

a defect in the plastic at or near the surface but must then consume the plastic substrate to reach 

new additive, a food source, which does occur and results in the biodegradation recorded. (RPFF 

¶ 1724). 
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Dr. Barlaz testified that the priming effect theory is based on unsupported assumptions 

that when the ECM additive is degraded, it stimulates the inoculum and results in an increase in 

background methane. (RPFF ¶ 2018). Dr. Barlaz testified that the priming effect, as described 

by Complaint Counsel’s witnesses, was “speculative” and “quite a stretch to dismiss ... data on 

the basis of a priming effect.” (RPFF ¶ 2019). Dr. Barlaz testified that the “priming effect” 

theory was first described in the peer reviewed literature in context with aerobic systems only, 

and then only with readily degradable substrates. (RPFF ¶ 2020). Dr. Barlaz explained that the 

priming effect theory described by Complaint Counsel’s witnesses has not been reported in the 

peer-reviewed literature with respect to anaerobic systems and slowly degradable substrates like 

the ECM additive. (RPFF ¶ 2021). Dr. Barlaz explained that, per Dr. McCarthy’s report, the 

ECM additive was mostly polycaprolactone (PCL), and in Dr. Barlaz’s own research, the amount 

of degradation solely from PCL was not that significant to stimulate background methane. 

(RPFF ¶ 2022). Dr. Barlaz explained that, in the absence of any peer reviewed literature or 

evidentiary support, which Complaint Counsel’s experts did not provide, the priming effect 

theory was “quite speculative as a way to shoot down a test.” (RPFF ¶ 2023). Comparing a 

potential priming effect from a readily degradable substrate in an aerobic environment to a 

slowly degradable substrate in an anaerobic environment is not an appropriate comparison 

scientifically. (RPFF ¶ 2024). Dr. Barlaz also explained that the amount of biodegradation 

observed in the ECM tests is much higher than anything that can be attributed to a priming effect 

and, so, the so-called “priming effect” would need to be massive to swallow the test results. 

(RPFF ¶ 2025). According to Dr. Barlaz, given the amount of biodegradation observed, “if 

someone is going to use [the priming effect] to throw out data, I’d like to see something more 
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than this, what to me is this is [a] theoretical possibility without supporting data.” (RPFF ¶ 

2026). 

Dr. Sahu testified in a complementary manner that the theory of a “priming effect” 

presented by Complaint Counsel’s witnesses was unsupported. (RPFF ¶ 2027). Dr. Sahu 

testified, as did Dr. Barlaz, that the amount of methane and carbon dioxide gas emitted from the 

test vessels far exceeded that which could have been sourced by the inoculum and the ECM 

additive. (RPFF ¶ 2028). Dr. Sahu testified that the amount of gas generated in the tests had to 

come from the test plastic. (RPFF ¶ 2029). 

Furthermore, as a way to check against the priming effect, Dr. McCarthy suggested that 

the laboratories test the ECM additive by itself to determine how much, if any, methane would 

be sourced from the additive alone. (RPFF ¶ 2030). Unbeknownst to McCarthy that was 

actually done. In one of his BMP tests, Dr. Barlaz actually did test the ECM additive by itself 

and did discover the amount of methane produced. (RPFF ¶ 2031). 

In that test (CCX 951), Dr. Barlaz reported that the amount of methane produced from 

the ECM additive alone, under BMP testing conditions that favor biodegradation, was 151.2 mL 

CH4/g. (RPFF ¶ 2032). Thus, the additive, when tested by itself, did not produce a priming 

effect equivalent to that which Complaint Counsel ascribes to other positive ECM tests. (RPFF ¶ 

2033). Moreover, the additive produced methane within the range that Dr. Barlaz had calculated 

based on his Buswell equation memorialized in RX 968. (RPFF ¶ 2034). Based on Dr. 

McCarthy’s own suggestion, therefore, the data in CCX 951 contradicts Dr. McCarthy’s (and 

Complaint Counsel’s) priming effect theory. (RPFF ¶ 2035). 

 Put differently, even assuming a priming effect existing in these systems, there is no 

evidence that the effect is quantifiable, consistent, or sufficient to account for the amount of 
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methane generated. There is no evidence that any of the test standards developed for the testing 

of plastics biodegradation ever included controls to address the so-called priming effect. There 

is no evidence that Complaint Counsel’s own witnesses factored or controlled for the priming 

effect when they performed their own biodegradation gas evolution tests. 

 Finally, Complaint Counsel’s dismissal of ECM tests that reported single digit 

biodegradation is erroneous. Tests must be compared to negative controls, or untreated plastics 

without the ECM additive. For instance, a 2011 test of ECM’s additive in a Low Density 

Polyethylene plastic bag revealed 5.94% biodegradation in 30 days. (RPFF ¶ 2504). The 

product contained 1.5% of the ECM additive. (RPFF ¶ 2493). When compared to the cellulose 

positive control the rates seem low (the cellulose had degraded to more than 86% in the same 

time period).173 However, in that same 30-day period, and under so-called “optimal” conditions, 

the negative control had degraded just 0.09%.174 Therefore, 5.94% biodegradation in a short 

term lab test is powerful validation for a product that is not otherwise biodegradable. In fact, in 

this test, the laboratory extended the duration to one calendar year, and recorded total 

degradation of the test plastic of about 17%. (RPFF ¶ 2504). The rate of biodegradation slowed, 

but continued consistently well beyond the amount that could fairly be attributable to ECM’s 

additive.175 

                                                             173 RX 838. 

174 RX 838. 175 RX 838.
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6. Complaint Counsel’s Scientific Experts Tolaymet, McCarthy, and Michel 

Are Not Credible 

a. Dr. Thabet Tolaymat’s “Expert” Opinion Is Not Credible or Reliable 

When fashioning his expert opinion in this case, Complaint Counsel’s witness Dr. 

Tolaymat rejected dozens of scientific tests (including gas evolution tests) outright because he 

deemed them to be unreliable or methodologically flawed. (Tolaymat, Tr. 296; CCX 893 

(Tolaymat, Rep. at 39–46)). 

He took positions that were in conflict with the EPA’s statements concerning landfills, 

including, for example, his position on “dry tomb” landfills. (RX 967). Dr. Tolaymat never 

bothered to consult with colleagues at the EPA, even though he was aware that there were others 

in EPA with substantially more experience with landfills and landfill gases. (Tolaymat, Tr. 216–

17). Furthermore, Dr. Tolaymat is an agent of a sister government agency. (Tolaymat, Tr. 216–

17). Far from an objective witness, Dr. Tolaymat represents the U.S. Government, the same 

entity prosecuting ECM for false or misleading claims. 

Complaint Counsel retained Dr. Tolaymat back in 2010. (Tolaymat, Tr. 214). Although 

he guided Complaint Counsel as a consultant, and now a testifying witness, Dr. Tolaymat 

performed no research of the major issues in this case. (Tolaymat, Tr. 214). He spent a total of 

80 hours on the case in almost four years of work, and much of that was spent drafting portions 

of his expert report. (Tolaymat, Tr. 214). 

Dr. Tolaymat’s efforts to shape testimony in Complaint Counsel’s favor are obvious and 

unsupported by facts or science. For example, he testified repeatedly that ECM’s gas evolution 

testing was wholly inadequate to substantiate biodegradable claims because those tests did not 

“replicate” the landfill environment. (Tolaymat, Tr. 235–37). In fact, he admitted that his sole

reason for rejecting most those studies was because they did not “simulate” the landfill. 
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(Tolaymat, Tr. 243). He explained that he would have rejected those studies even if they were 

perfectly run—which he cannot know, because he did not perform any analysis of the study data. 

(Tolaymat, Tr. 296, 314–15). Dr. Tolaymat never performed any statistics, and ignored the 

statistical calculations in Dr. Barlaz’s work. (Tolaymat, Tr. 314–17). 

 Then, in a volte face, Dr. Tolaymat later testified that he would accept a BMP gas 

evolution study as competent and reliable evidence of biodegradation in landfills. (Tolaymat, Tr. 

220–21). He would accept that test despite it being less representative of the landfill 

environment than the D5511 tests which he rejected on the sole basis that they did not simulate 

the typical landfill. (RPFF ¶¶ 2751–59). He admitted at the hearing that the BMP test “does not 

simulate” a landfill and it differs “dramatically” from the typical U.S. landfill. (RPFF ¶¶ 2757–

58). Yet, while the BMP test was somehow acceptable to Dr. Tolaymat, the D5511 test was not. 

Those two positions are impossibly conflicted, and reveal just how tortured Dr. Tolaymat’s 

“expert” analysis had become. 

 Dr. Tolaymat could not abandon the BMP testing, because he himself (and many others) 

had used it to assess biodegradability of plastics, another contradiction in his testimony. (RPFF ¶ 

2768). Instead, he argued that more evidence in addition to the gas evolution studies would be 

required. To get there, Dr. Tolaymat argued that field studies (in-situ landfill studies) or 

lysimeter studies were required. (RPFF ¶¶ 2723, 2729–42). But Dr. Tolaymat had never seen 

such a study conducted, and he was ill-prepared to advocate for same. (RPFF ¶¶ 2728–45). In 

fact, Dr. Tolaymat admitted that the field studies suffered from fatal design flaws and had more 

potential variables than tests he had rejected precisely for having too many variables (e.g., 

Environ PVC). (RPFF ¶¶ 2743). No other expert in the case advocated for in situ studies 
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because they were impractical and unnecessary. (Barlaz, Tr. 2236) (Dr. Barlaz “strongly 

disagree[d] with Dr. Tolaymat’s theory on in situ landfill testing). 

 In advocating for in situ studies, Dr. Tolaymat testified that weight loss was a valid 

endpoint to measure biodegradation. (RPFF ¶ 2745). Dr. Tolaymat again contradicted himself, 

as he had argued originally that the Environ BioPVC testing was flawed precisely because it 

relied on gravimetric (weight loss) endpoints. (RPFF ¶¶ 2742–45). In order to support his in situ

testing theory, Dr. Tolaymat completely reversed his opinion on weight loss endpoints without 

any reasoned basis. (RPFF ¶¶ 2742–45). He later conceded that weight loss was an acceptable 

end point; which was a complete contradiction to what he had stated under oath just hours 

earlier. (RPFF ¶¶ 2742–45). 

 Dr. Tolaymat had recommended to Complaint Counsel that he perform a BMP test of the 

ECM additive. (RPFF ¶ 2761). He testified at length during his deposition that he could run 

tests, and that he had recommended to Complaint Counsel that he should run a BMP (i.e., the gas 

evolution test which is less representative of a landfill than a D5511 reactor test) to assess the 

performance of the ECM additive. (RPFF ¶¶ 2761–65). Then, in another contradiction, Dr. 

Tolaymat testified during re-direct that he could not have tested the ECM additive because it was 

suddenly against the EPA’s policy. (RPFF ¶¶ 2761–65). 

 Dr. Tolaymat set impossibly high standards for biodegradation testing that were not 

corroborated by any expert or peer reviewed literature. In fact, he admitted that, to meet his 

impossibly high standards, a company seeking to market a “biodegradable” plastic would likely 

need to test their product for 20 years. (RPFF ¶ 2778). Although he agreed that biodegradation 

tests are ordinarily “accelerated” to show an effect within reasonable time constraints, he also 

testified that a test must precisely mirror the landfill environment. (RPFF ¶¶ 2778–80). 
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Otherwise, if tests did not mirror the landfill environment, he would outright reject the tests as he 

did with all 30 ECM gas evolution tests. That point notwithstanding, Dr. Tolaymat literally 

could not explain the contradictory positions in his testimony, to wit, how a test could both be 

accelerated to show biodegradation but also simulate the landfill precisely. (RPFF ¶¶ 2787–88). 

In response to questions concerning how a test can be a replication and accelerated at the same 

time, Dr. Tolaymat refused to answer, and simply stated that his explanation would “take more 

than this court has time to allow.” (Tolaymat, Tr. 250). Indeed. 

 Following the many contradictions and untenable explanations, Dr. Tolaymat proved that 

his “expert” opinion is not reliable. (RPFF ¶¶ 2707–85). He either lacks the requisite expertise 

to offer a sound opinion, or he biased his opinions beyond repair to promote Complaint 

Counsel’s case. Among the many other errors well-documented in ECM’s Proposed Findings of 

Fact (RPFF ¶¶ 2707–85), consider the following: 

 Dr. Tolaymat did not perform any research to familiarize himself with concepts 

relevant to the case. (RPFF ¶¶ 2720, 2789). 

 He admitted to having no expertise or knowledge of the bacterial communities in 

landfills (even though he wrote about same in his report). (RPFF ¶¶ 2795–02). 

 He admitted to having no expertise or knowledge of the enzymatic processes that 

occur in landfills (he could not even name the enzyme that degraded cellulose). 

(RPFF ¶¶ 2795–02). 

 He did not consult with anyone at the EPA concerning the areas where he was lacking 

in knowledge. (RPFF ¶¶ 2711–16). 

 He did not perform any statistical analyses of the tests or raw data relevant to the 

case. (RPFF ¶¶ 2853–57). He did not calculate or consider the theoretical gas yields 
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from the ECM additive and, so, he also did not consider whether the amount of 

methane recorded in the ECM tests would necessarily be attributed to the test plastic. 

(RPFF ¶¶ 2857–64). Indeed, none of Complaint Counsel’s experts reviewed the 

raw data or performed statistical analyses required to interpret same. 

(McCarthy, Tr. 654; Michel, Tr. 2966). 

 He could not reconcile his “dry tomb” landfill theory with the undisputed evidence of 

methane production in landfills nationwide, including the data that comes from EPA. 

(RPFF ¶¶ 2877–85; RX 967). 

 He recommended the use of scientific tests that had never been used by the relevant 

scientific community (or industry) to show biodegradation of specific materials (e.g., 

in situ studies and lysimeter studies). (RPFF ¶¶ 2733–34). 

 He rejected positive ECM tests because researchers took “weekly” gas measurements, 

when Dr. Tolaymat himself had performed gas evolution studies using weekly gas 

measurements (and sometimes less frequent measurements). (RPFF ¶¶ 2872–76). 

 Repeatedly in his “expert” report, Dr. Tolaymat revealed that he did not understand 

how “half-lives” work. (RPFF ¶¶ 2776–77). He consistently calculated the lifespan 

of materials by doubling the half-lives, which he later admitted was erroneous at the 

hearing, but only after having been confronted with his mistake at his deposition. 

(RPFF ¶¶ 2776–77). 

 He was unfamiliar with test standards at issue in this case. For instance, he entirely 

excluded D5511 studies when they exceeded 60 days, solely because he thought 

extended testing was not permitted by the D5511 test protocol, yet the D5511 test 
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method does not set a durational limit and actually encourages testing to continue. 

(RPFF ¶¶ 2784–86). 

 He discounted the use of chloride ions in the Environ BioPVC study because he 

thought that the chloride ions came from the ECM additive (rather than the plastic). 

(RPFF ¶¶ 2821–25). He held to that position despite also testifying that the ECM 

additive “shouldn’t” contain polyvinyl chloride. (RPFF ¶ 2823). 

 Those errors are only a subset of the errors apparent in his testimony. However, each of 

those errors is substantial and reveal Dr. Tolaymat not credible as an expert in this case. His 

testimony is unreliable, and his opinions should be devalued. 

b. Dr. Steven McCarthy’s “Expert” Opinion Is Not Credible or Reliable 

i. Dr. McCarthy’s Shifting Positions 

Dr. McCarthy submitted an expert report in this case on June 4, 2014. (RPFF ¶ 266). In 

his report, without the benefit of citation to the scientific literature, he stated that 

“microorganisms do not produce enzymes that metabolize plastic.”176 He gave short shrift to the 

notion that naturally produced enzymes could metabolize conventional plastics, which, he 

argued, “remain resistant to microbial attack.”177 Dr. McCarthy also stated unequivocally that 

conventional plastics are not biodegradable, again without citation to the scientific literature. 

(RPFF ¶ 1487). He explained that the “evidence indicates that the minimal biodegradation 

observed in the tests ECM relies on is the result of the ‘priming effect,’ i.e., biodegradation of 

the additive (which contains organic compounds highly susceptible to biodegradation) and the 

                                                             176 CCX 891 (McCarthy, Rep. at 29–30). 

177 See id.
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organic materials of the test medium (the bacteria used for testing) rather than the plastic.”178 Dr. 

McCarthy offered those opinions without the benefit of a single supportive citation; indeed, he 

generally avoided citations throughout his report.179

ECM’s experts countered with a large body of peer-reviewed literature showing that 

conventional plastics can be, and are in fact, enzymatically degraded. ECM’s experts explained 

that the phenomena observed in ECM’s tests were supported by the peer reviewed literature.180 

In response, Dr. McCarthy presented a rebuttal report on June 30, 2014, wherein he did not 

defend his original position but instead developed the argument that ECM’s additive was not 

efficacious due to amorphous versus crystalline structures of plastic polymers.181 Therein he did 

a volte face explaining that conventional plastics may be biodegradable after all, however, only 

amorphous sections of the plastic could biodegrade: “The material to biodegrade is the 

amorphous region of a polymer, which biodegrades at a fast rate. If the material were 50% 

crystalline, then the biodegradation rate would be very rapid until it reached 50% 

biodegradation.”182 Of course, Dr. McCarthy never posits or explains the percentage he actually 

thinks is “amorphous” in ECM’s plastic products tested; nor does he rely on scientific literature 

to establish a foundation for his amorphous versus crystalline opinion. (RPFF ¶¶ 1553–54).183 

He likewise fails to explain what percentage of crystalline polymers are present in his patented 

“blends” of polyesters that are manufactured using blending techniques like ECM’s technology 

                                                             178 CCX 891 at 36. 

179 See generally, id. 180 See RX 855 (Sahu Rep. at 29–40 (collecting references demonstrating the enzymatic 

biodegradability of certain plastics)); RX 854 (Burnette, Rep. at 17–22). 

181 See 892 (McCarthy, Rebuttal Rep. at 10). 

182 Id. 183 See generally, CCX 891 (McCarthy, Rep.); CCX 892 (McCarthy, Rebuttal Rep.); 

McCarthy, Tr. 359–690. 
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or the contradictory fact that he deemed the patented blends “biodegradable” in their entirety 

without regard to the percentage of amorphous and crystalline structures within them.184 

Complaint Counsel also presented the rebuttal testimony of Dr. Frederick Michel. 

Complaint Counsel had negotiated stipulations concerning Dr. Michel’s testimony as a fact 

witness, and held him out as a potential fact witness.185 On June 30, 2014, Complaint Counsel 

suddenly added without prior notice Dr. Michel as a rebuttal expert witness, all within 24 hours 

of the expert discovery cutoff.186 

In response, ECM moved to add a surrebuttal witness, Dr. Steven Grossman.187 Dr. 

Grossman is a professor of plastics engineering and a colleague of Dr. McCarthy, Complaint 

Counsel’s scientific expert.188 Dr. Grossman works in the same department as Dr. McCarthy.189 

The court denied leave to allow Dr. Grossman’s surrebuttal.190 Dr. Grossman would have 

provided crucial concerning false or misleading statements in Dr. McCarthy’s expert report and 

testimony as revealed in an offer of proof supplied to the Court. (RPFF ¶ 3004). 

                                                             184 RX 928. 

185 See Resp.’s Mot. For Sanctions, to Exclude Complaint Counsel’s Concealed Expert 

Rebuttal Witness, and For Leave to Include Surrebuttal Expert (July 9, 2014). 186 See id. 

187 See id. 

188 See id.

189 See id.

190 Order on Resp.’s Combined Mot. For Sanctions, to Exclude Expert Witness, and for 

Leave (July 23, 2014). 
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ii. Dr. McCarthy’s Hypocritically Demands that ECM Rely on 

Experimental Testing Methods and Standards that Dr. 

McCarthy Neither Uses Nor Requires for His Own Claims of 

Biodegradability in Plastics 

Dr. McCarthy’s expert report stated that any deviation from the protocol prescribed in 

ASTM D5511 invalidates biodegradation testing, but he himself does not use ASTM testing in 

his own biodegradation tests at UMass-Lowell or in his scientific publications, using instead a 

different gas evolution test he designed, referred to as UML-7645 in his ‘199 patent. (RPFF ¶ 

1467).191 Moreover, Dr. McCarthy testified that carbon 14 radiological testing is the only test 

that can definitively prove plastic biodegradation, but he himself has never used carbon 14 

radiological testing and has instead relied on extrapolation and other tests (that neither adhere to 

an ASTM standard nor involve radiological markers) to prove biodegradation, such as one he 

used at UMass., UML-7645; he also uses measures of weight loss to prove biodegradability of 

polymer products. (RPFF ¶¶ 1449–1453, 145–60, 1503, 1508). Dr. McCarthy also claims, again 

without any support in the peer-reviewed literature, that in order to prove biodegradation “[t]he 

study must last long enough for the sample to reach at least 60% biodegradation.”192 Dr. 

McCarthy makes that assertion after authoring peer-reviewed literature and a patent wherein he 

concludes that polymers are biodegradable when they have biodegraded only 14% in 45 days. 

(RPFF ¶ 1542). 

Dr. McCarthy broadly asserts that extrapolation is prohibited, thus substantively 

condemning his own published work and patent, deeming here for the first time 100% 

biodegradation in the laboratory to be required. (RPFF ¶¶ 1540, 1542). Similarly, Dr. McCarthy 

believes that “one of the most serious flaws in the conclusion of [ECM’s] experts is that once 

                                                             191 CCX 891 (McCarthy, Rep. at 34). 

192 Id. at 15. 
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biodegradation is established, it will continue to completion.” (RPFF ¶ 1556). However, Dr. 

McCarthy’s ‘199 patent made biodegradable claims even though the rate of biodegradation was 

lower than 60%, reaching only 14% in 45 days, and where he did not use a negative control. 

(RPFF ¶¶ 1542, 1557). Further, much of Dr. McCarthy’s prior research on biodegradable 

plastics did not meet the same 60% threshold that he states in his report is required of ECM’s 

additive. (RPFF ¶ 1543). 

Dr. McCarthy authored the scientific content of patent number 5,883,199. (RPFF ¶ 

1397). In that patent, Dr. McCarthy tested the biodegradation rates of five different polymer 

blends and claimed that those and various additional polymer blends are biodegradable. (RPFF ¶ 

1449). In order to do so, Dr. McCarthy used not an ASTM standard method, but a gas evolution 

test method he developed at UMass-Lowell, known as UML-7645. (RPFF ¶¶ 1467, 1541). Dr. 

McCarthy ran UML-7645 for only 45 days and on only five polymer blends. (RPFF ¶¶ 1459, 

1467). Despite running the test for only 45 days, Dr. McCarthy extrapolated the results to 

conclude that all five blends and additional blends are biodegradable. (RPFF ¶ 1459). UML7645 does not require radiolabeling. (RPFF ¶ 1453). UML-7645 is not even an ASTM test 

method. (RPFF ¶ 1451). UML-7645, like ASTM D5511, is simply a gas evolution test.193 

During the 45 day test, some of the polymer blends biodegraded by more than 60% and others 

did not.194 For example, the polylactic acid blend degraded by about 14% in 45 days. (RPFF ¶ 

1463). Patent ‘199 contains no requirement that polymer blends fully biodegrade in order to be 

considered biodegradable. (RPFF ¶ 1454).195 Patent ‘199 contains no requirement that polymer 

                                                             193 RX 928. 

194 Id., at fig. 11. 

195 RX 928. 
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blends biodegrade by 60% in order to be considered biodegradable.196 Nowhere in the patent 

does Dr. McCarthy establish that any of the five polymer blends decompose into elements found 

in nature within one year after customary disposal. (RPFF ¶ 1456). Nevertheless, Dr. McCarthy 

concluded that all five of the blends, and additional blends, are biodegradable. (RPFF ¶ 1461).197

Dr. McCarthy does not consider PET to be biodegradable. (RPFF ¶ 1469). In the ‘199 

patent, however, Dr. McCarthy claims that PET blended with PLA is biodegradable. (RPFF ¶ 

1468).198 Similarly, Dr. McCarthy considers PET to be a homopolymer. (RPFF ¶ 1530). 

Nevertheless, patent ‘199 deems a blend of a homopolymer to be biodegradable. (RPFF ¶ 1531). 

Dr. McCarthy also asserts in his expert report that a study used to determine whether something 

is biodegradable must include a negative control, (RPFF ¶ 1472) , yet patent ‘199 does not 

include a negative control in the underlying tests despite the patent representation that the blends 

are biodegradable. (RPFF ¶¶ 1472–1474).199 

Dr. McCarthy authored an article entitled “Advances in Properties and Biodegradability 

of Co-Continuous, Immiscible, Biodegradable, Polymer Blends.” (RPFF ¶ 1496; RX 940). In 

that article, Dr. McCarthy measured the biodegradability with proteinase K in soil and 

composting for the blends which are the basis for the ‘199 patent. (RPFF ¶¶ 1496–1501). In 

measuring biodegradability of polymer blends in that article, Dr. McCarthy did not use carbon 14 

radiolabeling testing. (RPFF ¶¶ 1496–1501). In measuring biodegradability of polymer blends 

in that article, Dr. McCarthy did not rely on an ASTM standard testing method. (RPFF ¶¶ 1496–

1501). Like in patent ‘199, Dr. McCarthy used his university’s own testing method to determine 

                                                             196 Id. 

197 Id..

198 One must wonder why, then, Dr. McCarthy is so quick to dismiss data evidencing that 

a blend of PET and ECM Additive renders a biodegradable plastic. (RPFF ¶ 1966). 

199 RX 928.
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biodegradability of polymers. (RPFF ¶¶ 1496–1501; RX 940). In that article, Dr. McCarthy 

concluded that certain test samples were biodegradable without proving that they completely 

biodegraded within one year after customary disposal. (RPFF ¶ 1501; RX 940). 

Dr. McCarthy also authored an article entitled “Biodegradable Polymer Blends of 

Poly(lactic acid) and Poly(ethylene glycol).” (RPFF ¶ 1502). In that article, Dr. McCarthy 

measured enzymatic degradation based solely on a weight loss calculation. (RPFF ¶ 1503). Like 

in his patents and other articles, and contrary to his positions in this case, Dr. McCarthy 

measured enzymatic biodegradation without using an ASTM standard and without using any 

radiolabeling testing. (RPFF ¶¶ 1504–05). 

 Dr. McCarthy co-authored an article entitled “Degradation Ranking of Plastics in a 

Landfill Environment.” (RPFF ¶ 1506). Once again, in that article, Dr. McCarthy measured 

degradation rates. (RPFF ¶¶ 1507–09). This time, like Dr. Barber, Dr. McCarthy used weight 

loss to measure degradability. (RPFF ¶ 1508). Dr. McCarthy used qualitative measurements, 

such as looking at the samples to evaluate whether the samples looked weathered, in order to 

determine the samples’ degradability. (RPFF ¶ 1510). Once again, in that article, Dr. McCarthy 

did not use any ASTM method or any radiolabeling to determine degradation. (RPFF ¶¶ 1507, 

1509). 

Dr. McCarthy authored an article entitled “Biodegradable Blends of Bacterial Polyesters 

with Polyethylene and Polystyrene.” (RPFF ¶ 1511). No author of Biodegradable Blends of 

Bacterial Polyesters with Polyethylene and Polystyrene established that the polyethylene and 

polystyrene blends tested completely break down and return to nature within one year after 
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customary disposal. (RPFF ¶ 1512). Nevertheless, the authors concluded that the polyethylene 

and polystyrene blends were biodegradable.200

Dr. McCarthy co-authored an article entitled “The Effect of Hyperbranched Polymers on 

Processing and Thermal Stability of Biodegradable Polyesters.” (RPFF ¶ 1513). In that article, 

Dr. McCarthy characterized polyhydroxybutyrate as wholly biodegradable. (RPFF ¶ 1514). At 

his deposition, Dr. McCarthy testified that the authors of that article did not determine that 

existence of biodegradation predicated upon establishment that the polyhydroxybutyrate 

completely broke down and returned to nature decomposing into elements found in nature within 

one year after customary disposal. (RPFF ¶ 1516). Dr. McCarthy contradicted himself at trial, 

stating that the authors of that article established that polyhydroxybutyrate completely 

decomposed into elements found in nature within one year after customary disposal. (RPFF ¶¶ 

1514–16). Nothing in the article so states. (RPFF ¶ 1515). 

Dr. McCarthy co-authored an article entitled “Microwave-Assisted Solvent-Free or 

Aqueous-Based Synthesis of Biodegradable Polymers.” (RPFF ¶ 1517). At his deposition, Dr. 

McCarthy testified that this article did not establish that the polymers would biodegrade such that 

they would break down and return to nature decomposing into elements found in nature within 

one year after customary disposal. (RPFF ¶ 1519). However, once again, Dr. McCarthy 

contradicted himself at trial, testifying that the article established that the polymers would 

biodegrade such that they would break down and return to nature, decomposing into elements 

found in nature within one year after customary disposal. (RPFF ¶ 1518). Nothing in the article 

so states.201

                                                             200 RX 945. 

201 RX 948. 
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Dr. McCarthy believes that a biodegradation study must last long enough for the same to 

reach at least 60 percent biodegradation. (RPFF ¶ 1539). Dr. McCarthy also agrees that 

ordinarily 60 percent biodegradation of a sample is not something that can occur in a just a few 

minutes. (RPFF ¶ 1561). Dr. McCarthy also co-authored an article entitled “The Influence of 

Injection Molding Conditions on Biodegradable Polymers.” (RPFF ¶ 1558). In that article, Dr. 

McCarthy analyzed certain polymers for their rates of biodegradation. (RPFF ¶ 1562). 

Remarkably, Dr. McCarthy measures rates of degradation in that study by conducting a test that 

lasted only five minutes. (RPFF ¶ 1562). Yet, Dr. McCarthy relied on those five minute tests to 

draw conclusions about the biodegradability of polymers. (RPFF ¶ 1562). The five minute tests 

failed to demonstrate 60 percent biodegradation. (RPFF ¶ 1562). 

iii. Dr. McCarthy’s Failure to Consider Scientific Data 

In his expert report, Dr. McCarthy makes sweeping conclusions regarding the ECM 

additive, such as that “after blending the ECM additive with conventional plastic, the 

conventional plastic remains non-biodegradable.”202 However, Dr. McCarthy does not base that 

specific conclusion, or any of his sweeping conclusions, on either product testing or reference to 

any peer-reviewed scientific article.203 Furthermore, unlike Dr. Barlaz, Dr. McCarthy conducted 

no statistical analyses of any tests measuring the biodegradation of plastics infused with the 

ECM additive. (RPFF ¶ 1568). 

                                                             202 CCX 891 (McCarthy, Rep. at 250). 

203 Id. 
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iv. Dr. McCarthy’s Adoption of a Litigation Definition for 

“Biodegradable” that Is Not Supported by Science 

For purposes of this litigation, Dr. McCarthy decided to define biodegradable to mean 

precisely what the Green Guides defines biodegradation to mean: “that the entire treated plastic 

will completely break down and return to nature (i.e., decompose into elements found in nature) 

within one year after customary disposal (i.e., incinerator, landfill or recycling).” (RPFF ¶ 

1361). Dr. McCarthy further stated that this definition of “biodegradable” is “interchangeable” 

with the scientific definition of “biodegradable.” (RPFF ¶ 272). 

No published peer-reviewed scientific definition of “biodegradable” includes either a one 

year time limit or a requirement that the treated plastic completely break down and return to 

nature (i.e., decompose into elements found in nature). (RPFF ¶¶ 798–800). In fact, Dr. 

McCarthy in his own scientific publications on biodegradation of plastics has never defined 

biodegradable in the same way he defines biodegradable for purposes of this litigation. (RPFF ¶ 

1372). Consistent with the scientific definition, Dr. McCarthy has previously written that the 

“the definition of biodegradable polymer varies greatly among scientists, manufacturers, and 

consumers.” (RPFF ¶ 1375). At trial, Dr. McCarthy admitted that “[m]any different definitions 

[of biodegradation] have officially been adopted, depending on the background of the defining 

standard organizations and their particular interests.” (RPFF ¶ 786). Dr. McCarthy’s own 

writings, outside of this litigation, defining biodegradation do not include the qualifier that an 

item must completely breakdown within a period of one year. (RPFF ¶ 787). Under cross 

examination, when pressed for any evidence that the definition he uses “for purposes of this 

litigation” was replicated anywhere in the scientific literature, Dr. McCarthy stated, “actually, I 

believe I would like to change that.” (RPFF ¶ 1368). 
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Unlike Dr. McCarthy’s and Complaint Counsel’s arbitrary definitions, scientific literature 

defines the term “biodegradable” as an on-going process: “the chemical dissolution of materials 

by bacteria or by other biological means.” (RPFF ¶ 774). “Biodegradation takes place by the 

action of enzymes, chemical degradation with living organisms.” (RPFF ¶ 775). Biodegradation 

has been described as a “two step” process. ((RPFF ¶ 776). “The first step is the fragmentation 

of the polymers into lower molecular mass species by means of abiotic reactions, like oxidation, 

photodegradation or hydrolysis, or biotic reactions, like degradations by microorganisms.” 

(RPFF ¶ 777). The second step is “the bioassimilation of polymer fragments by the 

microorganisms and their mineralization.” (RPFF ¶ 778). Degradation results “from the action 

of naturally occurring microorganisms such as bacteria, fungi, and algae.” (RPFF ¶ 779). 

Similarly, the Merriam-Webster dictionary defines “biodegradable” as something 

“capable of being slowly destroyed and broken down into very small parts by natural processes, 

bacteria, etc.” or “capable of being broken down especially into innocuous products by the action 

of living things (as microorganisms).” (RPFF ¶ 780). Other sources have defined 

“biodegradable” to mean “capable of being decomposed by bacteria or other biological means.” 

(RPFF ¶ 781). 

Some standards have been put in place by various organizations that attempt to define a 

time span for this process, but biodegradation is not subject to a time span limitation because it is 

an ongoing process. (RPFF ¶ 810). Still, the ASTM definition of “degradable plastics” mirrors 

the accurate scientific definition which is that a degradable plastic is a plastic that will break 

down into different chemical materials. (RPFF ¶ 811). Slightly different, the ASTM definition 

of “biodegradable plastics” is a plastic which breaks down by natural biota. (RPFF ¶ 812). The 

ASTM definition of “biodegradation” contains no requirement that the test plastic completely 
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break down into elements found in nature within one year of customary disposal. (RPFF ¶ 813). 

Indeed, the ASTM has never defined biodegradation as the test plastic completely breaking down 

into elements found in nature within one year of customary disposal. (RPFF ¶ 796). Further, the 

plastics industry has never adopted a definition of biodegradation that requires a plastic product 

to completely decompose and break down into elements found in nature within one year after 

customary disposal in a landfill. (RPFF ¶ 814). 

Likewise, fact witnesses and expert witnesses for both parties in this litigation have 

defined biodegradable to be unrelated to any temporal restraint. (RPFF PP 782 –814). 

Complaint Counsel’s expert witness Dr. Tolaymat testified that “[b]iodegradation is the 

conversion of organic matter through the action of bacteria and fungi into more elementary 

components or elements.” (RPFF ¶ 782). Dr. Tolaymat’s definition of biodegradation includes 

no time limit or time constraint. (RPFF ¶ 783). Contrary to Dr. McCarthy’s time restricted 

definition of biodegradation, Complaint Counsel’s expert witness Dr. Michel testified that 

“biodegradation is the mineralization of materials as a result of the action of naturally-occurring 

microorganisms such as bacteria and fungi.” (RPFF ¶ 788). 

Dr. Timothy Barber, a neutral fact witness, testified that biodegradation is a process by 

which microbial organisms sustain their life by eating and metabolizing a material. (RPFF ¶ 

792). He also testified that whether something is “biodegradable” requires the determination of 

whether biological organisms, microbial organisms, sustain their life functions and eat and 

metabolize this material. (RPFF ¶ 809). 

Dr. Sahu testified that the common scientific definition of biodegradation is degradation 

by biological means and that “biodegradation means different things to different researchers ... 

or in different contexts.” (RPFF ¶¶ 790–91). Dr. Sahu also testified that “in all contexts 
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[biodegradation] simply means the breakdown of whatever is the object of interest using 

biological means, using essentially biota such as bacteria or fungi or other type of naturally 

occurring or evolving biota in the environment.” (RPFF ¶ 794). Dr. Burnette testified that “from 

a microbiological standpoint [biodegradation] really is [] the conversion of ... one substance to 

another substance as the result of biological activity.” (RPFF ¶ 793). 

Despite his definition of “biodegradable” used “for purposes of this litigation,” Dr. 

McCarthy readily admits that not even tree trunks, orange peels, or banana peels, all generally 

accepted to be biodegradable in the environment, can reliably break down into elements found in 

nature within one year after customary disposal. (RPFF ¶ 805). 

v. Dr. McCarthy Is a Biased Witness with Financial Interests in 

the Outcome of This Litigation, and His Testimony Reflected 

That Bias 

Complaint Counsel retained Dr. Steven McCarthy approximately two years ago as a 

consultant, and eventually as a testifying witness against ECM in this case. (CCX 891) Dr. 

McCarthy’s scientific positions were apparent in Complaint Counsel’s pre-complaint decisions. 

Email correspondence from Complaint Counsel to ECM in July 2013 mirrored the content in Dr. 

McCarthy’s expert report. (RPFF ¶ 1534; Compare e.g., RX 593 with CCX 891). Dr. McCarthy 

is a professor at UMass Lowell in Massachusetts (“UMass”). (RPFF ¶ 1428; RX 841 

(McCarthy, Dep. at 15)). He is not a reliable expert witness. (RPFF ¶ 1353–80). He has 

accepted on behalf of UMass millions of dollars in funding from ECM competitors that offer 

bioplastics and compostable products. (RPFF ¶ 1396; CCX 891, at 42–44 (McCarthy’s CV)). 

Dr. McCarthy has directly profited from research he performed for ECM competitors. (RPFF ¶ 

1398–05, 1408–11). UMass-Lowell has boasted of Dr. McCarthy’s income earning potential, 
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noting in 2012 that Dr. McCarthy “has obtained nearly $9 million in externally sponsored 

research grant and contracts, plus nearly $33 million in intellectual property donations to UMass 

Lowell.” (RPFF ¶ 1407). Dr. McCarthy’s success at UMass appears directly linked with his 

ability to generate income through IP “donations” and grant money. 

For instance, Dr. McCarthy directly profits from compostable plastic resin patent 

royalties paid to UMass. (RPFF ¶¶ 1403–04). Under an agreement with the University and in 

accordance with UMass policy, Dr. McCarthy assigned his patent rights in a compostable plastic 

resin he invented to UMass. (RPFF ¶ 1408; RX 841 (McCarthy, Dep. at 57). In exchange, he 

receives a profit share of the royalty stream. (RPFF ¶ 1409; RX 841 (McCarthy, Dep. at 59). 

One of Dr. McCarthy’s patents was purchased, and has been used, by an ECM competitor, 

Metabolix Inc. (RPFF ¶ 1401; RX 362 (U.S. Patent No. 5,883,199 (issued Mar. 16, 1999)). To 

the extent Metabolix’s sales increase based on incursions into ECM’s market, royalties from the 

patent will increase and Dr. McCarthy’s income from those royalties will increase as well. 

(RPFF ¶ 1405; RX 841 (McCarthy, Dep. at 51–52, 55–61). Once again, UMass is the patent’s 

assignee. (RPFF ¶ 1399; RX 761; RX 757 (Metabolix Website Article)). Metabolix is the 

exclusive licensee of the technology. (RPFF ¶ 1401; RX 209). Metabolix’s potential royalties 

from licensing UMass patents exceed $100,000 per year. (RPFF ¶ 1402; RX 209). Dr. McCarthy 

testified that he receives money directly from the ‘199 patent, which is licensed by Metabolix. 

(RPFF ¶¶ 1403–04, 1409; RX 841 (McCarthy, Dep. at 59–60). He acknowledged that 

Metabolix’s products compete directly with ECM’s technology for market share. 204 (RPFF ¶ 

1412). To date, Dr. McCarthy has received about $28,000 in royalties from the patent. (RPFF ¶ 

                                                             204 RX 841 (McCarthy, Dep. at 64–66) (acknowledging that it is a competitive 

marketplace and that products based on the ‘199 patent are in competition with other products 

marketed as biodegradable, compostable, and recyclable). 
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1404). Metabolix has paid more than any other funder to the UMass Lowell Bioplastics and 

Medical Plastics Center. (RPFF ¶ 1434). Overall, Metabolix has paid approximately one and a 

half million dollars in grants to UMass Lowell. (RPFF ¶ 1435). Metabolix has also reimbursed 

UMass Lowell for equipment the university purchased. (RPFF ¶ 1436). 

Ignoring conflicts of interest concerns, Metabolix employees have worked directly 

alongside both Dr. McCarthy and his students. (RPFF ¶ 1437). Dr. McCarthy’s students are 

available to work for Metabolix whenever Metabolix requests. (RPFF ¶ 1438). Metabolix 

employees actually oversee the work of Dr. McCarthy’s students to ensure that the conditions are 

those that Metabolix wants. (RPFF ¶¶ 1439–40). Metabolix then pays the university for the 

students’ time, and the university subsequently pays the students with the money paid by 

Metabolix. (RPFF ¶ 1441; McCarthy, Tr. 533–34). In essence, Metabolix pays Dr. McCarthy’s 

students to perform work for Metabolix. (RPFF ¶ 1441). Metabolix has paid up to $200,000 per 

year as part of this “fee for service” agreement between UMass Lowell and Metabolix. (RPFF ¶ 

1433). UMass Lowell and Metabolix’s relationship is such that Metabolix essentially leased 

storage space from the university and has donated items, such as air compressors, to the 

university. (RPFF ¶ 1430). In sum, one of ECM’s competitors is paying Dr. McCarthy’s 

students through the fee for service agreement, Dr. McCarthy’s employer through grants, leases, 

and royalties, and Dr. McCarthy himself through royalties. If the Commission is successful 

against ECM in this matter (and by extension against similar additive products), Metabolix’s 

market share increases along with the return to Dr. McCarthy from his royalty payments. 

Although this patent reveals a direct financial interest by Dr. McCarthy in the outcome of the 

litigation, it is not the only evidence revealing such an interest. 
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Dr. McCarthy collects a share of research grant money that he secures for UMass Lowell 

from compostable product competitors of ECM, such as Metabolix and other compostable 

product manufacturers.205 

Metabolix supplied grants to UMass of approximately $2.5 million, sponsored more than 

50 students for their master’s and doctorate degrees, and has made substantial equipment 

donations (over $500,000). (RPFF ¶ 1427; RX 210). Since 2008, Metabolix has also lobbied the 

FTC to act against ECM. (RPFF ¶ 1414; RX 211 (requesting FTC to investigate Good Earth and 

ECM for alleged deceptive environmental claims)). Natureworks, one of the companies 

Metabolix sublicenses the patent to, is ECM’s competitor. (RPFF ¶¶ 323, 1411). Dr. McCarthy 

has worked with BPI, and collected substantial revenue (approximately $40,000), performing 

BPI “certifications” for trade customers in the compostable industry which compete with ECM. 

(RPFF ¶¶ 1421–22; RX 841 (McCarthy, Dep. at 92). Metabolix is also a member of the 

Biodegradable Products Institute (“BPI”), a primary ECM competitor, and sells approximately a 

dozen products that are “BPI certified” in direct competition with ECM. (RPFF ¶ 1415; RX 171; 

RX 172). BPI is a vocal opponent of ECM, and has lobbied the FTC repeatedly since at least 

2005 to act against ECM and ECM’s customers. (RPFF ¶ 1417–19; RX 744 (BPI 

Correspondence to FTC of April 25, 2005)). 

Dr. McCarthy’s personal affiliations and financial interest in ECM’s competitors makes 

his scientific opinions unreliable because he has well established financial interests in opposition 

to those of ECM. He is an agent of ECM’s competitors, profiting directly from their success 

either by the receipt of royalties, payment for services (such as his service for years as a certifier 

                                                             205 RX 841 (McCarthy, Dep. at 52–55) (explaining that a project account receives fortysix percent (46%) of the research grants Dr. McCarthy secures, and that he is in control of that 

account when he is the principal investigator). 
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for BPI, or grants to UMass-Lowell in support of his research). A successful prosecution of 

ECM and the additive market would bestow a substantial windfall on Metabolix, BPI and related 

compostable product manufacturers, who would immediately stand to gain market advantage. 

Dr. McCarthy is compensated $100/hour for his work in this matter (except deposition and trial 

testimony). (CCX 891). The idea that he would enter an opinion in a high profile FTC case that 

cut against the businesses that support him financially defies credulity. Indeed, the evidence 

suggests that he tailored his opinion to meet Complaint Counsel’s needs, even accepting the 

fundamental definition of what “biodegradation” means from Complaint Counsel, despite 

contrary representations in his own scientific articles and in his own patent. (RPFF ¶¶ 269–74, 

1360–71). 

Dr. McCarthy has adopted positions that contradict prior work he performed for ECM’s 

competitors. For example, his expert report stated that carbon 14 radiolabeling testing is the only 

testing that can dispositively prove that ECM’s additive causes biodegradation of plastics, but he 

himself has relied on extrapolation and other tests (that neither adhere to an ASTM standard nor 

involve radiological markers), such as one he created himself, UML-7645, and measures of 

weight loss, to prove biodegradability of polymer products. (RPFF ¶¶ 1449–80, 1539–64; RX 

841 (McCarthy, Dep. at 74–75, 148–149, 165–172). In his published works outside of this 

litigation, Dr. McCarthy has never mentioned the need for a product to biodegrade within a year 

to be deemed biodegradable, and yet, for ECM’s additive, Dr. McCarthy is adhering to the one 

year rule contained in FTC’s Revised Green Guides in collaboration with Complaint Counsel.

(RPFF ¶¶ 1538–64).206

                                                             206 RX 841 (McCarthy, Dep. at 19, 20–42, 69–76 (explaining that the ‘199 patent used 

the term “biodegradability” without requiring complete biodegradation within a year), 185–187 
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Moreover, Dr. McCarthy’s report stated that “evidence that a substance is biodegradable 

is not ‘competent and reliable’ unless the tested sample reaches ‘at least 60% biodegradation,’ 

and there is both a ‘negative control’ and a ‘positive control,’” but Dr. McCarthy’s ‘199 patent 

made biodegradable claims even though the rate of biodegradation was far less than 60%. (RPFF 

¶¶ 1539–64; RX 756, at Figure 11). 

Dr. McCarthy himself has used the very same test methods ECM has used to demonstrate 

a “biodegradable” product before the U.S. Patent and Trademark Office. Dr. McCarthy’s prior 

research on biodegradable plastics did not meet the same 60% threshold that he now requires of 

ECM’s additive. (RPFF ¶¶ 1539–64, 1611; RX 756, at Figure 11). Dr. McCarthy’s insistence on 

carbon 14 testing is not the consensus in the relevant scientific community. (RPFF ¶¶ 1608–17). 

Perhaps caught on the science, Dr. McCarthy’s June 30, 2014 rebuttal report eventually 

presented new theories in response to ECM’s expert testimony that had not before been 

presented by Complaint Counsel. For instance, Dr. McCarthy had previously contended that the 

“priming effect” would have accounted for the positive results in ECM’s testing. (RPFF ¶ 267). 

When the priming effect was eventually debunked by ECM’s experts, Dr. McCarthy developed a 

new theory, that it was the split between amorphous and crystalline properties of plastic 

polymers that prevented complete biodegradation. (RPFF ¶¶ 1551–54; CCX 892, at ¶ 22). He 

also posited that polyethylene polymer chains could only be reduced through the use of prooxidants, which ECM’s technology did not involve. (CCX 892, at ¶ 11) Truth be told, ECM’s 

additive falls within the types of alternative technologies that have been shown to facilitate 

polyethylene degradation, (RPFF ¶¶ 2131, 2180–2706), and, contrary to Dr. McCarthy’s 

testimony, amorphous and crystalline structures are not separate and distinct in plastics but 

                                                                                                                                                                                               

(explaining that a banana peel, tree trunk, and orange peel are biodegradable even if they do not 

biodegrade within a year of customary disposal). 
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overlap and are inextricably intertwined, (RPFF ¶¶ 1749–53). While crystalline structures may 

slow down biodegradation, it is a false assertion that they stop or prevent it. (RPFF ¶¶ 1757–62). 

 Consequently, the evidence reveals that Dr. McCarthy has fashioned his scientific 

opinion to suit Complaint Counsel’s purposes and further Dr. McCarthy’s financial interests. Dr. 

McCarthy is not an objective expert in this case, and his opinion should be rejected as biased, 

impeached through inconsistency, and lacking a foundation in supportive peer reviewed 

scientific evidence. 

F. Complaint Counsel Has Failed to Prove that Claims Concerning 

Biodegradation Rate Are Material to Purchasing Decisions 

“To establish that an act or practice is deceptive under Section 5, the FTC must 

demonstrate that ‘(1) there was a representation; (2) the representation was likely to mislead 

customers acting reasonably under the circumstances; and (3) the representation was material.’” 

F.T.C. v. NHS Syss., Inc., 936 F. Supp. 2d 520, 531 (E.D. Pa. 2013) (citations omitted). In order 

to determine whether an advertisement is material, “[t]he basic question is whether the act or 

practice is likely to affect the consumer’s conduct or decision with regard to a product or 

service.” Cliffdale Assocs., Inc., 103 F.T.C. 110, at *45 (1984)). “In other words, [information 

that is material] is information that is important to consumers.” Id. at *49. As the Seventh 

Circuit stated, “[a] claim is considered material if it involves information that is important to 

consumers and, hence, likely to affect their choice of, or conduct regarding, a product.” Kraft, 

Inc. v. F.T.C., 970 F.2d 311, 322 (7th Cir. 1992) (internal quotations and citations omitted); see 

also F.T.C. v. Colgate-Palmolive Co., 380 U.S. 374, 391 (1965) (citing F.T.C. v. Raladam Co., 

316 U.S. 149, 152 (1942)) (“when the Commission finds deception it is also authorized, within 
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the bounds of reason, to infer that the deception will constitute a material factor in a purchaser's 

decision to buy”). 

The FTC applies a presumption of materiality to “(1) express claims; (2) implied claims 

where there is evidence that the seller intended to make the claim; and (3) claims that 

significantly involve health, safety, or other areas with which reasonable consumers would be 

concerned.” Id. The first situation applies “[w]here the seller knew, or should have known, that 

an ordinary consumer would need omitted information to evaluate the product or service, or that 

the claim was false,” and, in such a circumstance, “materiality will be presumed because the 

manufacturer intended the information or omission to have an effect.” Matter of Cliffdale, 103 

F.T.C. 110 (1984). The third situation can apply when the advertisement concerns information 

that “pertains to the central characteristics of the product or service.” Id. 

“A representation is material if likely relied upon by a reasonable prospective purchaser.” 

F.T.C. v. Wash Data Ress., 856 F. Supp. 2d 1247, 1272 (M.D. Fla. 2010). Importantly, “[r]ather 

than an isolated word, phrase, or sentence, the representations net impression controls.” Id. at 

1272 (citations omitted). “What is important in determining whether a statement is misleading is 

the over-all impression it tends to create on the public.” Country Tweeds, Inc. v. F.T.C., 326 

F.2d 144, 148 (2d Cir. 1964) (citing Murray Space Shoe Corp. v. F.T.C., 304 F.2d 270 (2d Cir. 

1956)). 

A respondent can counter a presumption of materiality with extrinsic evidence. See In 

the Matter of Pom Wonderful LLC, 2012 WL 2340406 (F.T.C. May 17, 2012). As explained in 

POM Wonderful and Novartis: 

Respondent can present evidence that tends to disprove the predicate fact from 

which the presumption springs (e.g., that the claim did not involve a health 

issue) or evidence directly contradicting the initial presumption of materiality. 

This is not a high hurdle. Unless the rebuttal evidence is so strong that the fact 
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finder could not reasonably find materiality, the fact finder next proceeds to 

weigh all of the evidence presented by the parties on the issue. See id. at 516 

(noting that after the presumption drops out, “the inquiry ... turns from the few 

generalized factors that establish [the presumption] to the specific proofs and 

rebuttals ... the parties have introduced”). 

Id. at *235. “Materiality turns upon whether those consumers who have drawn the claim from 

the advertisement and have been misled by it are also likely to have their conduct affected by 

the misrepresentation.” In re Novartis Corp., 127 F.T.C. 580, 691 (1999) (emphasis added). 

 ECM’s claims concerning the rate of biodegradation are not material because (1) ECM 

and its customers made those claims ostensibly for regulatory compliance purposes, and not as 

performance claims; (2) the claims largely were not passed along in commerce, and rarely to end 

users and, in any event, consumer survey evidence proves that consumers did not regard rate 

claims as material; (3) ECM’s customers were only concerned with having the ability to market a 

“biodegradable” product and not with the rate of biodegradation; and (4) the specific rate of 

degradation is not scientifically or environmentally material. 

 First, ECM identified a specific rate of biodegradation not as a comparative or 

performance claim in the market. The testimony revealed that ECM began using its “5 year” 

claim as a means to differentiate its technology from more rapidly degrading compostable 

products and predicated on testing results obtained by additive inventor and former ECM owner 

Patrick Riley and those of ECM President Robert Sinclair and Chief Financial Officer Ken 

Sullivan. (RPFF ¶¶ 45–54, 308).207 In those tests in 50 gallon drums, the ECM infused plastics 

broke down within 9 months to 5 years. (RPFF ¶ 53–54). ECM wanted to be clear that its 

products would not perform like the compostable products, which were expected to fully degrade 

in aerobic conditions in under 6 months (180 days). (RPFF ¶ 308). ECM chose a period of 9 

                                                             207 See CCX 818 (Sinclair, Dep. at 77–79, 85–88). 
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months to 5 years at a time when the scientific understanding of landfills and biodegradation was 

evolving, thinking that the 5 year qualification would provide an adequate buffer. In 2012, when 

the FTC revised the Green Guides, ECM changed its claim language (permanently discontinuing 

the “9 month to 5 year claim,” added more qualifications, and informed customers that 

biodegradation claims should only be made if the specific customer had evidence sufficient to 

meet the Green Guide recommendations. (RPFF ¶ 309).208 

 ECM customers therefore considered ECM’s “rate” claims only with respect to 

regulatory compliance. The record reveals that ECM customers did not consider rate claims 

material but instead sought to discern if the additive enabled plastics to become more 

biodegradable than plastics without the additive. (RPFF ¶¶ 321, 329, 330, 359). 

There is literally no evidence that the actual rate of biodegradation was ever important to 

ECM customers or their subsequent customers. (RPFF ¶ 729).209 One customer, BER Plastics, 

was asked about whether the ECM additive “would make plastic biodegrade in nine months to 

five years” and, tellingly, the witness replied: “Never really thought about the – how long it 

would take to biodegrade.” (RPFF ¶ 605).210 Still more customers testified that rate of 

biodegradation was only significant to the extent it showed the products were “biodegradable” 

                                                             208 See RX 195, at 121 n.409 (noting that studies supporting the “one year” rule “may be 

faulted for lacking control groups and presenting the timeframe questions with closed-ended, 

rather than open-ended, answers, but they nevertheless are the only studies in the record”). 

209 Island Plastic Bag’s customer, Down to Earth, testified through its agent only that the 

rate claims was a significant part of the reason for purchasing ECM’s product, but also noted that 

“price” was a major factor. See CCX 803 (Santana, Dep. at 39–40). Complaint Counsel never 

asked “why” the rate claim was important to the customer. 

210 See CCX 800 (Ringley, Dep. at 32). Another customer, Kappus Plastics, was asked 

whether they considered the “nine months to five years” claim a “rigid standard,” and the witness 

responded apathetically: “Again, we’re not really saying anything. We took information that 

was provided and moved it from one piece of paper to the other. It says it on the piece of paper.” 

See CCX 812 (Kappus, Dep. at 50) (noting that the rate claim was not perceived by the witness 

as “rigid”). 
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generally or “green.” (See generally, RPFF ¶¶ 605–725). 211 Similarly, another customer, Quest 

Plastics, was generally uninterested in the “rate” of degradation. When asked about ECM’s five 

year claim, the witness testified: 

Q: So your assumption, when you read the claims on the website, 

was that if it stated it was fully biodegradable in nine months to 

five years, that it would fully biodegrade in nine months to five 

years? 

A: I didn’t know, and I left it up to my customer to decide whether 

this is what he wanted to use.212

 

(RPFF ¶ 707). 

According to the witness, his customer was simply “looking for an additive to make the 

biodegradable – the gold tee biodegradable.” (RPFF ¶ 705).213 

 That lack of interest in the rate claim is reflected in the advertising before the Court. 

Throughout the hundreds of thousands of pages of advertising and correspondence in Complaint 

Counsel’s possession, the so-called “rate” claim for biodegradation has appeared relatively 

infrequently, and rarely when compared to the more general “biodegradation” claim. If the rate 

claim was material and important to purchasing decisions, then ECM’s customers would pass 

that information along in commerce routinely, but they didn’t. Indeed, doing so, was the rare 

exception. The claim was unimportant.214 In fact, Complaint Counsel has recorded pictures and 

samples of many ECM goods that actually reached the end consumer, and, with very few 

                                                             211 See CCX 882, at 12–13. 

212 See CCX 817 (Bean, Dep. at 32). 

213 Id. at 33. 

214 The majority of advertisements do not mention rates of biodegradation: RX 00, RX 

02, RX 03, RX 14, RX 15 (focus on cost), RX 16 (logo only), RX 17 (general biodegradable 

claim), RX 22, RX 26, RX 28, RX 29, RX 30, RX 315 (cost the focus), CCX 30 (general focus 

on biodegradability); CCX 31 (same), CCX 32, CCX 36 (labeling instructions to downstream 

customers without including rate); CCX 39, CCX 43, CCX 46, CCX 47, CCX 49, CCX 50, CCX 

52, CCX 59 (focus on shelf life), CCX 60 (same), CCX 63, CCX 64, CCX 65 (focus on “green), 

CCX 66, CCX 79. 
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exceptions, every product includes only a generalized “biodegradable” claim without reference 

to, or reliance on, the rate of biodegradation.215 Complaint Counsel acknowledges that, more 

than selling just an additive, ECM really “sells the purported ability to make a ‘biodegradable’ 

advertising claim.”216 Exactly—which is indicative of the fact that ECM’s customers are 

unconcerned about the rate of biodegradation, except to the extent it would influence their ability 

to make a “biodegradable” claim broadly. (RPFF ¶¶ 605–725). That means ECM’s customers 

did not base their purchasing decisions on ECM’s rate claims, but on the fact of biodegradation 

without regard to the precise rate. Customers were primarily concerned just with the 

“biodegradable” claims, and testified as such. (RPFF ¶¶ 605–725).217 More importantly, 

however, the customers were interested in a “biodegradable” product that could work with their 

manufacturing systems, because the plastic had to serve a function foremost. (RPFF ¶ 340). 

Small companies particularly devoted substantial test resources to that inquiry, as Island Plastic 

Bags explained: 

Q: And in the email David Hong is stating that he was experimenting with 

ECM plastic for over a year. 

A: So what we—what I believe he was doing was—and we didn’t, like, test 

it or anything, what we were doing is seeing if we could actually run it 

through our machines, because it could—you know, ECM at that time 

said it’s biodegradable, but it doesn’t do us any good if we can’t use it 

through our machines. So what we were doing was putting the additive 

                                                             215 All of the following exhibits represent photos of the actual consumer goods that are 

eventually labeled “biodegradable,” but without reference or focus on the rate of biodegradation: 

CCX 97, CCX 98, CCX 99, CCX 100, CCX 10, CCX 103, CCX 104, CCX 107, CCX 109, CCX 

110, CCX 111, CCX 112, CCX 113, CCX 114, CCX 115, CCX 116, CCX 117, CCX 118, CCX 

119, CCX 120, CCX 121, CCX 122, CCX 123, CCX 124, CCX 125, CCX 126, CCX 127, CCX 

128, CCX 129, CCX 130 (specifically says time “will vary due to local conditions”), CCX 131, 

CCX 132, CCX 133, CCX 135, CCX 136, CCX 138, CCX 139, CCX 140, CCX 142, CCX 143, 

CCX 144, CCX 145, CCX 146, CCX 147, CCX 148, CCX 149, CCX 150, CCX 151. 

216 See, e.g., CC Pretrial Br. at 15. 

217 See, e.g., CCX 811 (Hong, Dep.). 
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inside of our plastics to see if it could actually run through our extruders 

and then be cut and sealed as plastic bags.218

(RPFF ¶ 340). 

 The lack of materiality is also confirmed through expert testimony. Dr. Stewart testified 

that, based on several surveys of high methodological value, end users or consumers have no 

uniform understanding of “how long” it should take an item to decompose in landfills. (RPFF ¶¶ 

1315–16).219 There is also an understanding among many consumers that the length of time 

required for an item to degrade is dependent on a variety of factors including the material from 

which it is made and the conditions under which degrading occurs. (RPFF ¶ 1311).220 

Consumers also expressed considerable skepticism over rate claims that were presented to them 

in relation to plastic products. (RPFF ¶ 1337).221 Thus, according to Dr. Stewart, the results of 

his survey evidence make clear that consumers are highly unlikely to be misled by ECM’s 

product claims because “(1) there is no shared understanding among consumers of the length of 

time required for an item to decompose and (2) the lack of understanding and skepticism of the 

claims make it highly unlikely that the claims will have a material influence on the consumer.”222 

Put simply, if the consumer has no reasonable or accurate knowledge of how long a plastic 

should take to biodegrade in the environment, then they cannot adequately or reasonably 

interpret whether ECM’s rate claim is good or bad.223 The rate claim is very different from other 

familiar rate claims, for example miles-per-gallon (MPG), where consumers can correlate a rate 

                                                             218 CCX 811 at 44. 

219 RX 856, at 15 (Stewart Rep.). 

220 RX 856. 221 Id. 222 Id.

223 Assuming, arguendo, that consumers really do expect a product to biodegrade within 

one year, then ECM’s 5-year claim would have a negative influence on purchasing decisions. 

Those customers would think the product did not meet their expectations. 
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with performance. Furthermore, there is no evidence in this case that ECM’s competitors have 

offered rate claims that differ from ECM’s, such that a consumer would be drawn to an ECM 

product through comparative advertising. 

 In deposition testimony, Dr. Barlaz described his attempts to calculate rates of 

degradation in landfill environments.224 He testified that his work was experimental, and that the 

precision of his rates fluctuated sometime by a factor of two.225 Complaint Counsel questioned 

whether the fluctuations would be considered significant, and Dr. Barlaz explained that it was 

not all that important: 

Q: Is a factor of two large or small? I really don’t know. 

A: Sure. My opinion would be that, for a landfill, a factor of two is fine, 

because the retention time is infinite. If I were in an engineered tank 

where I were putting stuff in, I needed it to biodegrade at a certain rate 

so I knew when to take it out so I could put more in, then the rate affects 

the size of the tank, and the size of the tank affects the cost of the tank. 

Then people would be interested in something better than a factor of 

two. 

Q: So can you just give me an example—I work better with hard numbers, 

so just an example of how—and I understand that you don’t recall the 

specific results were, but the difference between inocula coming from an 

anaerobic digester versus inocula coming from a sewage treatment plant, 

if those were two different types of inocula that you were looking at? 

A: They were. 

Q: Did you understand my question? 

A: Let me—you are asking me, as I understand it, for an example of the 

difference in laboratory scale decay rate as calculated for a substrate, for 

example, copy paper, on two different inocula, for example, anaerobic 

sewage sludge and leachate? 

Q: Yes. 

                                                             224 See RX 864 (Barlaz, Dep. at 106–108). 

225 RX 864 at 107. 
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... 

Q: Okay. You said your testimony was a factor of two is fine for landfills 

because their retention time is infinite. So meaning it could take longer 

than whatever the average is? 

A: What I mean is that, if I estimate a half-life of three years and the actual 

half-life is six years or one-and-a-half years, it’s inconsequential for the 

performance of the landfill. Either way, there is biodegradation 

occurring because the material is in the landfill, in essence, forever. 

That’s what I mean by infinite retention time. Whether we are off a few 

years in either direction, it doesn’t really seem to matter.226

The salient point made by Dr. Barlaz is that there is no material benefit to a product that 

biodegrades in a landfill in, say, 15 years versus another that degrades in 30 years. The more 

rapidly degrading product offers no material environmental benefit, and indeed, a plastic product 

that completely biodegrades in a landfill within one year after customary disposal actually harms 

the environment as a net contributor to global methane emissions. (RPFF ¶¶ 1604–05). Landfill 

operators do not change waste management techniques based on the biodegradable speed of 

plastics and, in turn, plastics manufacturers are not motivated by a need to somehow ensure any 

particular rate of biodegradation. What, then, is the materiality of a rate claim other than to 

satisfy the FTC’s flawed and unscientific standards in 16 C.F.R. § 260.8? 

 Finally, ECM permanently discontinued use of the “9 months to 5 years” rate claim at the 

center of Complaint Counsel’s case in 2012 when the FTC revised its Green Guides. (RPFF ¶¶ 

315–15).227

                                                             226 RX 864 at 109–110; RPFF ¶¶ 1604–05). 

227 Complaint Counsel has identified several limited instances where ECM distributed the 

9 month–5 year rate claim accidentally by releasing outdated brochures or flyers to customers, 

but those have not been shown to have been intentional or material to the ECM customer and 

were against the direction of Robert Sinclair, ECM’s President. 
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1. To Determine Whether A Claim is False or Misleading, the Trier of Fact 

Must View the Claim from the Perspective of the Target Audience 

“In reviewing allegedly false and misleading statements, courts are to read the statements 

in their entirety and in context to determine whether they are actionable.” Schering-Plough 

Healthcare Prods., Inc. v. Schwartz Pharma, Inc., 547 F. Supp. 2d 939, 943 (E.D. Wisc. 2008) 

(citing Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134, 1139 (9th Cir 1997) (“When 

evaluating whether an advertising claim is literally false, the claim must always be analyzed in 

its full context”)); Castrol, Inc. v. Pennzoil Co., 987 F.2d 939, 946 (3d Cir. 1993) (“in assessing 

whether an advertisement is literally false, a court must analyze the message conveyed in full 

context”); Schwarz Pharma, Inc. v. Breckenridge Pharm., Inc., 388 F.Supp.2d 967, 976 (E.D. 

Wis. 2005) (“To determine whether a particular representation is literally false, it must be 

analyzed with its full context”)). “In addition, the specific audience is part of the context that 

must be considered in deciding whether a statement is literally false.” Id. “Context can often be 

important in discerning the message conveyed and this is particularly true where, as here, 

the target of the advertising is not the consuming public but a more well informed 

and sophisticated audience.” Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 

229 (3d Cir. 1990) (emphasis added) (citation and internal quotation marks omitted); see also 

DeSena v. Beekley Corp., 729 F. Supp. 2d 375, 393 (D. Me. 2010) (“A target audience’s special 

knowledge of a class of products is highly relevant to any claim that it was misled by an 

advertisement for such a product”). 

Similarly, under state anti-competition laws, “[w]hen the practice [at issue] is targeted to 

a sophisticated purchaser, the question of whether it is misleading to the public will be viewed 

from the vantage point of members of the targeted group, not others to whom it is not primarily 
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directed.” Ariz. Cartridge Remanufacturers Assoc., Inc. v. Lexmark Int’l, Inc., 290 F. Supp. 2d 

1034, 1041 (N.D. Cal. 2003). 

2. ECM’s Target Audience and Actual Customers Were Sophisticated 

Purchasers That Studied the Product and Engaged in Sophisticated 

Transactions 

In business transactions, when the selling company provides the purchasing company 

with specifications or data, such transactions are “classified as sophisticated.” John Crane Prod. 

Solutions, Inc. v. R2R and D, LLC, 861 F. Supp. 2d 792, 799 (N.D. Tex. 2012). In addition, 

there is less likelihood of confusion when the parties to a business transaction “have a close 

working relationship.” Id. at 801. In fact, “[c]ourts have found that the sophistication of the 

potential purchasers alone is enough to find that there is no likelihood of confusion even when all 

of the other digits [in the trademark context] weigh in favor of such a finding. See, e.g., Perini 

Corp. v. Perini Constr., 915 F.2d 121, 128 (4th Cir.1990) (reversing summary judgment because 

district court did not consider how sophistication of purchasers of construction services affected 

analysis, even though all other digits weighed in favor of finding likelihood of confusion).” Id. 

at n. 16. 

Courts have classified transactions and purchasers as sophisticated in a number of 

contexts. See, e.g., Checkpoint Sys., Inc. v. Check Point Software Tech., 269 F.3d 270, 285 (3d 

Cir.2001) (holding that purchasers of retail store security equipment and computer security 

software were sophisticated); Rust Env't & Infrastructure, Inc. v. Teunissen, 131 F.3d 1210, 1217 

(7th Cir. 1997) (holding that purchasers of services from engineering consulting firms were 

sophisticated); Oreck v. U.S. Floor Sys., Inc., 803 F.2d 166, 173 (5th Cir. 1986) (“Because these 

persons are buying [vacuums and extraction machines] for professional and institutional 
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purposes at a cost in the thousands of dollars, they are virtually certain to be informed, 

deliberative buyers.”); Armstrong Cork Co. v. World Carpets, Inc., 597 F.2d 496, 504 n. 10 (5th 

Cir. 1979) (“[A] person buying a ‘big ticket’ item such as carpeting would ordinarily be expected 

to be a more careful buyer than the impulse purchaser or the purchaser of a relatively 

inexpensive item”). 

ECM customers are sophisticated manufacturers often several layers removed from endconsumers.228 Moreover, Complaint Counsel has not identified precisely who the “endconsumer” might be here. ECM sells its additive to plastics manufacturers.229 Most (if not all) 

of ECM’s customers extensively test the ECM product before determining whether to 

incorporate ECM’s technology into their plastics.230 All 30+ of the gas evolution tests used in 

this case are not sponsored by ECM but by customers critically evaluating whether the product 

effected biodegradation of their own plastics before deigning to make a purchase. (RPFF ¶¶ 35, 

477, 1606, 2133, 2145, 2150, 2155, 2162, 2169, 2176, 2218, 2242, 2260, 2285, 2304, 2323, 

2347, 2364, 2457, 2478, 2507, 2524, 2534, 2550, 2559, 2581, 2603, 2616, 2627, 2640, 2650.) 

Those manufacturers generally sell to sub-manufacturers or distributors as bulk plastic 

products.231 The mid-level distributors market and sell items like plastic bags or packaging 

cushions to corporations (e.g., grocery stores or common carriers).232 A so-called “end 

consumer” thus never actually purchases an ECM plastic. They receive the ECM plastic either 

in the mail (for packaging products) or at the grocery store (for plastic grocery bags). Moreover, 

                                                             228 See, e.g., RX 178, at 34 (page labeled as “BPI 004025”). 

229 RX 875 (Sinclair, Tr. at 217:16–17) (ECM’s “customer[s] [are] plastic product 

manufacturers”). 

230 See, e.g., CCX 802 (Leiti, Dep. at 92) (noting that Dispoz-o conducted its own tests). 

231 See, e.g., RX 178, at 34 (page labeled as “BPI 004025”). 

232 See, e.g., CCX 811 (Hong, Dep. at 9–10) (explaining that Island Plastic Bags 

manufactures and sell plastic bags and plastic cutlery). 
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the ECM plastic is received by the end consumer after a sale in commerce. Thus, there is no 

evidence at all in this case that, for the bulk of the products ECM manufactures, a consumer ever 

makes a purchasing decision based on a single ECM claim or a single claim made by an ECM 

customer. 

ECM’s direct customers are ordinarily far larger than and equipped with more knowledge 

of plastics and degradation of their own plastics than ECM possesses.233 ECM’s customers, 

unlike ECM, are plastics manufacturing companies ordinarily with their own scientists, 

engineers, and lawyers. As plastics manufacturers, those companies are keenly aware of plastics 

chemistry. Moreover, the evidence suggests that most ECM competitors actively review 

competing products, and even test competing products to determine if ECM is the best fit from a 

performance and biodegradation perspective.234 

 Given that ECM has fully disclosed the nature of its products, there is transparency in 

ECM’s advertising and a distinct lack of deception in the market. ECM customers are given 

samples to test and testing is encouraged. ECM’s prospective customers often spend six months 

to two years evaluating the ECM product before deciding to infuse it into their plastics. 

Complaint Counsel argued in its Pretrial Brief that “[c]ustomers buy the ECM additive because 

they want biodegradable plastic—and they want to be able to advertise their plastic as 

biodegradable.”235 In fact, with the exception of several isolated instances, among what 

Complaint Counsel calls “millions” of customer contacts, claims concerning the rate of 

biodegradation have rarely appeared in the end-consumer market. Almost invariably, the end-

                                                             233 RX 875 (Sinclair, Dep. at 258) (ECM’s customer “have all the resources, ten times, 

hundred times the resources that [ECM] may have”). 

234 See, e.g. RX 159. 

235 See CC Pretrial Br. at 14 
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customer is provided with no claim at all or a naked “biodegradable” claim, which is the only 

claim ECM has in its certificate of biodegradability.236 

 Second, ECM has routinely provided its scientific testing in full to corporations and 

customers. That information has included clearly favorable data, but also tests that Complaint 

Counsel has used to suggest that ECM’s product is inefficacious. (RPFF ¶¶ 439, 465, 520, 683, 

2707). ECM’s willingness to share information in its negotiations with customers is evidence 

that ECM has in good faith attempted to explain the level of science supporting its product. It 

also reveals that ECM’s customers have had the information necessary to evaluate ECM’s claims 

and determine, just as ECM has, whether those claims are adequately supported. Unlike 

traditional retail sales where end-customers are often presented with little more than the product 

and a claim, in this case ECM’s sales have been preceded (and followed) by substantial 

interaction with corporate customers, including critical scientific and engineering evaluations by 

company purchasers before making a purchase decision. Significantly, many of the claims 

conveyed in the stream of commerce are not ECM’s claims but are those derived from company 

purchasers own experience with the product. Those claims are constructed by ECM’s customers 

based on information generated and reviewed by corporate customers and based on their finished 

plastic products, not ECM’s additive alone.237 

 ECM’s customers were aware of the FTC’s requirements in the Green Guides, and they 

tailored their advertising content according to those policies.238 One of ECM’s leading 

                                                             236 See, e.g., RX 17. 

237 See, e.g., CCX 48 (EcoSmart Plastic advertising that its products will “compost” in “9 

months–7 years”). 

238 See, e.g., RX 871 (Blood, Dep. at 193:10–21) (explaining that one of the reasons FP 

International changed its claim was “The FTC’s green guides [] even though [FP] didn’t agree 

necessarily with the one-year time frame that the FTC decided was appropriate”). 
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customers testified that they adapted advertising claims to fit their perception of the Green 

Guides: 

Q: How did FP come to the decision to transition its claims from the ones 

we discussed earlier to the claim that ECM plastic will biodegrade in 

landfills in one to five years or more? 

A: There were several contributing factors. One of them was the FTC’s 

green guides. And even though we didn’t agree necessarily with the 

one-year time frame that the FTC decided was appropriate, we decided 

that we would incorporate that to make it clear to our customers that it 

was not under a year. And so that was an element where we decided to 

go ahead and make that component of the claim, instead of the nine 

months.239

ECM customers have thus demonstrated that they understand the nature of ECM’s advertising 

claims, and have been guided substantially in their decision to choose certain marketing language 

by the FTC’s positions, which have skewed the claims in the market and effected a new national 

environmental policy. 

Recognizing those facts, Complaint Counsel struggles to define ECM’s purchasers 

misleadingly as “mom and pop”-type businesses that also apparently manufacture bulk plastic 

polymers, such as Island Plastic Bags. At sixteen (16) employees, Island Plastic Bags is more 

than twice the size of ECM, which has just six employees. That was the best example of a “mom 

and pop” manufacturer Complaint Counsel could marshal. In fact, Island Plastic Bags (“IPB”) 

has a sophisticated operation whereby they manufacture high- and low-density polyethylene 

products through various manufacturing plants in Hawaii and China.240 IPB learned of ECM’s 

product not through website materials or marketing, but through conversations with ECM 

representatives at a trade show.241 Although Island Plastic Bag testified (through extensive 

                                                             239 RX 871 (Blood, Dep.) 

240 See CCX 811 (Hong, Dep. at 10–11). 

241 Id., at 11–12. 
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leading questions), that it did not have experience to review scientific literature concerning 

biodegradability, they could not deny that they were provided that literature over the course of 

detailed discussions with ECM.242 And, certainly, they were able to test the ECM product for 

their intended uses. 

3. The Bases for Purchase Among Sophisticated Customers Differ from 

Those of End Use Consumers 

In order to succeed in a fraud action, a challenger must establish that he or she reasonably 

relied on the alleged material representation. Terra Sec. Asa Konkursbo v. Citigroup, Inc., 740 

F. Supp. 441, 448 (S.D.N.Y. 2010). “In assessing the reasonableness of a plaintiff’s alleged 

reliance, [courts] consider the entire context of the transaction, including factors such as its 

complexity and magnitude, the sophistication of the parties, and the content of any agreements 

between them.” Emergent Capital Inv. Mgmt., LLC v. Stonepath Grp., Inc., 343 F.3d 189, 195 

(2d Cir. 2003). For example, “[s]ophisticated investors must investigate the information 

available to them with the care and prudence expected from people with full access to 

information.” Terra, 740 F. Supp. 2d at 448 (citing Hirsch v. du Pont, 553 F.2d 750, 763 (2d 

                                                             242 As in many of the customer depositions that occurred throughout the country, this one 

in Hawaii, ECM was unable to have counsel appear and instead offered a corporate 

representative. While that decision was ultimately ECM’s, the lack of ECM’s counsel should not 

excuse Complaint Counsel’s objectionable examination throughout. Through leading questions, 

counsel essentially testified for the witness. See, e.g., CCX 811 (Hong, Dep. at 35–39). The 

flawed examinations limit the credibility of witness testimony. Out of court testimony from a 

witness that could have been called, and thus not subject to cross-examination or to judicial 

assessment of the character of the witness on the stand, is discredited because having not 

undergone the rigors of cross and judicial scrutiny, it cannot be presumed credible or complete. 

See, e.g., Fed. R. Evid. 804(b)(1) (deposition testimony is admissible as an exception to the 

evidentiary hearsay exclusion so long as the declarant is unavailable as a witness at the hearing , 

the deposition proceeded in compliance with law, and the party against whom the testimony is 

offered had an opportunity to develop the testimony by cross-examination). 
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Cir. 1977)); see also Banque Franco–Hellenique de Commerce Int’l., et Maritime, S.A. v. 

Christophides, 106 F.3d 22, 27 (2d Cir. 1997) (finding that analysis of reasonable reliance in 

fraud cases “has taken account of the degree to which the truth was accessible to the defrauded 

person”). The rationale is that the informed or sophisticated entity has the wherewithal to 

determine whether claims are supported and, so, the need to protect those sophisticated 

“consumers” is lessened. 

Other courts outside of the Second Circuit have similar requirements to determine 

whether sophisticated purchasers reasonably relied on misrepresentations. See, e,g,, Metavante 

Corp. v. Emigrant Sav. Bank, 619 F.3d 748, 767–68 (7th Cir. 2010) (finding that the plaintiff’s 

alleged reliance was unreasonable where “two sophisticated businesses negotiated an armslength transaction of a period of several months”); Tom Hughes Marine, Inc. v. Am. Honda 

Motor Co., Inc., 219 F.3d 321, 324 (4th Cir. 2000) (affirming decision that reasoned that the 

plaintiff was “a sophisticated businessman ... and he [was] unable to establish that he had a right 

to rely on [the defendant’s] representation or that he justifiably relied upon it”); Gilchrist Timber 

Co. v. ITT Rayonier, Inc., 95 F.3d 1033, 1035 (11th Cir. 1996) (collecting cases supporting the 

proposition that a fraud claim is not actionable where “the parties are equally sophisticated, and 

have an equal opportunity to discover a defect”); Cheney Bros., Inc. v Batesville Casket Co., Inc., 

47 F.3d 111, 114 (4th Cir. 1995) (citation omitted) (holding that “there is no right to rely, as 

required to establish fraud, where there is no confidential or fiduciary relationship, and there is 

an arm's length transaction between mature, educated people”); Kline v. First Western Gov’t 

Sec., Inc., 24 F.3d 480, 497–98 (3d Cir. 1994) (holding that the “investor could not justifiably 

rely on representations” where the transaction “was on the cutting edge of strategic planning”); 

Roberts v. United N. Mex. bank at Roswell, 14 F.3d 1076, 1080 at n. 4 (5th Cir. 1994) (internal 
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quotations and citations omitted) (“If an investor is sufficiently sophisticated and experienced, 

that may be evidence that he did not rely on the seller's representations but on his own 

expertise.”); Davidson v. Wilson, 973 F.2d 1391, 1399 (8th Cir. 1992) (noting that the 

“sophisticated investors should have been on notice not to rely upon those representations”); 

Skeen v. C.I.R., 864 F.2d 93, 95 (9th Cir. 1989) (explaining that where the plaintiffs “are all 

sophisticated businessmen,” the court “simply do[es] not believe that they would enter into 

profit-motivated transactions with an unknown party and rely solely on the representations of 

such part with respect to the most crucial aspect affecting the viability of the proposed venture”). 

4. Complaint Counsel Has Failed to Prove that Any Consumer Was Misled 

An “advertisement is deceptive under the [FTCA] Act if it is likely to mislead consumers, 

acting reasonably under the circumstances, in a material respect.” Kraft, Inc. v. FTC, 970 F.2d 

311, 314 (7th Cir. 1992). Courts have held that there is a reduced likelihood that a sophisticated 

party, as opposed to an unsophisticated party, will be influenced by a similar mark in an 

advertisement. See, e.g., Mead Data Dent., Inc. v. Toyota Motor Sales, U.S.A., Inc., 875 F.2d 

1026, 1031–32 (2d Cir. 1989). “The degree of consumer care and sophistication can be proven 

by survey evidence, expert testimony, or inference.” Marketquest Grp., Inc. v. BIC Corp., 2011 

WL 5360899, at *12 (S.D. Cal. Nov. 7, 2011) (citation omitted) (finding that the buyers were 

likely to be sophisticated because they were institutional buyers placing bulk orders and because 

the marketing materials “appear to be aimed at institutional purchasers”). 

The issue in Mead was whether the use of the term “Lexus” used by Toyota Motors 

would dilute the profitability of the term “Lexis” as used by Mead. Mead, 875 F.2d at 1027. 

The Second Circuit explicitly made clear that “the recognized sophistication of attorneys, the 
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principal users of [Lexis], has substantial relevance.” Id. at 1031 (emphasis added). Given the 

fact that Lexis’ users were principally sophisticated attorneys, the court concluded that there 

would not “be any significant amount of blurring between the LEXIS and LEXUS marks.” Id. at 

1032. 

Numerous additional courts likewise find that purchasers are less likely to be confused 

when they are sophisticated, technical, experienced, retailers, or otherwise involved in the 

industry or have any relevant knowledge. See, e.g., In re Synthroid Mktg. Litig., 264 F.3d 712, 

717 (7th Cir. 2001) (noting that “[u]nlike members of the consumers class, [third-party payers] 

are sophisticated purchasers”); Interstellar Starship Servs., Ltd. v. Epix Inc., 184 F.3d 1107, 1110 

(9th Cir. 1999) (citation omitted) (holding that confusion is less likely where the “customers are 

sophisticated industry and university researchers” and where the “goods cost in the range of 

several thousand to tens of thousands of dollars”); Homeowners Grp., Inc. v. Home Mktg. 

Specialists, Inc., 931 F.2d 1100, 1111 (6th Cir. 1991) (“A sophisticated purchaser exercises a 

high degree of care and is less likely to be confused as to a product's origin.”); Pride Family 

Brands, Inc. v. Carl’s Patio, Inc., -- F. Supp. 2d --, 2014 WL 186902, at *7 (S.D. Fla. Jan. 30, 

2014) (noting that “[as] industry participants, retailers are a sophisticated customer base”); 

Acxiom Corp. v. Axiom, Inc., 27 F. Supp. 2d 478, 497 (D. Del. 1998) (citations omitted) 

(explaining that “courts recognize that generally” when a seller “sell[s] relatively expensive 

products and services to sophisticated and knowledgeable purchasers that typically involve 

relatively long sales cycles . . . these factors indicate that great care, effort, and attention go into 

the purchase decision making which lessens likelihood of confusion.”); Giorgio Beverly Hills, 

Inc. v. Revlon Consumer Prods. Corp., 869 F. Supp. 176, 185 (S.D.N.Y. 1994) (citation omitted) 

(explaining that “[t]he more sophisticated the ordinary purchaser of a product is, the less likely it 
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is that the use of similar marks or trade dress will lead to confusion” and holding that “women 

tend to be sophisticated purchasers of perfume”); Marketquest Group Inc. v. BIC Corporation, et 

al., No. 11-cv-618, 2011 WL5360899, at *11 (S.D. Cal. Nov. 7, 2011) (noting that “experienced 

industry distributors or agents [] are likely to be sophisticated consumers and investigate any 

potential confusion”); In re Trans Union Corp. Privacy Litig., 2009 WL 4799954, at *11 (N.D. 

Ill. Dec. 9, 2009) (noting that insurance companies are sophisticated purchasers of legal 

services). 

Like in the trademark context, parties are held to different levels of duty of disclosure 

when conducting business with sophisticated purchasers as opposed to the general public. For 

example, a purchaser is under no duty to disclose the financial conditions of its business when 

“the parties are represented by sophisticated businessmen, who are active and experienced in the 

area, and are dealing at arm’s length without any fiduciary or confidential relationships or 

expectations.” Nationwide Book Indus., LLC v. A & S Booksellers, Inc., 950 F. Supp. 2d 264, 

267 (D. Mass. 2013) (citations and quotations omitted). Similarly, in the securities context, 

securities issuers must disclose significantly more information when making public offering as 

opposed to selling the securities only to sophisticated qualified institutional buyers. Gustafson v. 

Alloyd Co., 513 U.S. 561, 569 (1995) (citing 15 U.S.C. §§ 77b (11), 77d, 77e) (“By and large, 

only public offerings by an issuer of a security, or by controlling shareholders of an issuer, 

require the preparation and filing of registration statements.”). This is because the sophisticated 

purchaser, capable of fending for itself and determining the benefits and costs of entering a 

business transaction, is held liable for his or her own decisions. See, e.g., Miller v. Berman, 289 

F. Supp. 2d 1327, 1334 (M.D. Fla. 2003) (“Surely, as a sophisticated boat and sail maker, Mr. 
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Miller relied on his own expertise in deciding to enter into a contract for the purchase of a highly 

customized catamaran boat with Cougar Marine”). 

5. The Sophisticated Purchaser Defense Is Applicable in This Case 

A manufacturer’s duty to warn of dangers in the products liability context is “precluded 

in situations where the purchaser has particular knowledge of or experience with the inherent 

dangers in the use of a product or in instances when the purchaser has designed and requested a 

product for a particular application.” Byrd v. Hunt Tool Shipyards, 650 F.2d 44, 47 at n. 1 (5th 

Cir. 1981); see also O’Neal v. Celanese Corp., 10 F.3d 249, 252 (4th Cir. 1993) (“The 

[sophisticated purchaser] defense is available not only when the supplier actually warned the 

intermediary, but also when the supplier shows that it was reasonable to believe that a warning 

was unnecessary because the intermediary was already well aware of the danger”); Goodbar v. 

Whitehead Bros., 591 F. Supp. 552, 561 (W.D. Va. 1984 ) (“Stated another way, when the 

supplier has reason to believe that the purchaser of the product will recognize the dangers 

associated with the product, no warnings are mandated.”). This rule of law is known as the 

“sophisticated purchaser defense” which is “based upon the principles set forth in the 

Restatement (Second) of Torts.” Akin v. Ashland Chem. Co., 156 F.3d 1030, 1037 (10th Cir. 

1998). “This exception absolves suppliers of the duty to warn purchasers who are already aware 

or should be aware of the potential dangers.” Id. (citing O’Neal, 10 F.3d 249, 251–52 (4th Cir. 

1993); Davis v. Avondale Indus., 975 F.2d 169, 171 (5th Cir. 1992)). 

Indeed, in certain situations, a “manufacturer [may] reasonably [] rely on an intermediary 

purchaser to warn ultimate users of dangers associated with the use of a product.” Baker v. 

Monsanto Co., 962 F. Supp. 1143, 1151 (S.D. Ind. 1997). Such a situation arises where “it 
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would be impossible for a manufacturer to access all ultimate users of a product because it had 

no control over the site of usage.” Id. 

In this context, the sophisticated purchase defense precludes a finding that ECM’s 

representations to its plastic manufacturer customers were misleading. Assuming arguendo that 

harm results from making misleading advertisements to end consumers regarding a 

biodegradable claim (a difficult assumption given that there is no record evidence that an end 

consumer ever actually purchases a plastic infused with the ECM additive that bears an ECM 

claim), that harm is the harm of the target audience being misled. ECM’s target audience, 

however, is not end consumers but wholly sophisticated manufacturers of plastics. Therefore, 

because ECM’s customers were aware of the dangers associated with selling a “biodegradable” 

product, ECM had no duty to the end use consumer. Akin, 156 F.3d at 1037; O’Neal, 10 F.3d at 

251–52; Davis 975 F.2d at 171. That is particularly true where, as here, ECM’s customer 

performed independent testing on the products themselves, consulted with scientists, engineers, 

and legal counsel, and where ECM does not have access to all ultimate users of a product (or 

event knowledge of who they are) and has no control over the products made with its additive or 

the usage of the products made. Baker, 962 F. Supp. at 1151. 

G. Complaint Counsel’s Censorship of “Biodegradable” Claims Violates the 

First Amendment 

First Amendment protections directly apply to FTC orders and limit the expansion of 

FTC advertising regulation. See, e.g., Standard Oil C. of California v. F.T.C., 577 F.2d 653, 662 

(9th Cir. 1978) (“First Amendment considerations dictate that the Commission exercise restraint 

in formulating remedial orders which may amount to a prior restraint on protected commercial 
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speech”); Sears, Roebuck and Co. v. F.T.C., 76 F2d 385, 399 n.31 (9th Cir. 1982); Beneficial 

Corp v. FTC, 542 F.2d 611 (3d Cir. 1976); F.T.C. v. Simeon Management Corp., 532 F.2d 708, 

713 (1976) (“[a]lthough commercial advertising may be subject to regulation serving an 

important public interest, it is not beyond the protection of the First Amendment”). 

In the context of communications between ECM and its sophisticated customers, the 

basis for a purchasing decision is not advertising but, instead, is a classic information exchange 

leading to a customer obtaining a small portion of the product for preliminary independent 

testing whereupon if itself convinced of the product’s utility, it purchases and generally infuses 

its plastic with it. That scenario does not involve commercial speech (“speech that proposes a 

commercial transaction,” Bd. of Trustees of State Univ. of New York v. Fox, 492 U.S. 469, 482 

(1989)) but involves the exchange of fully protected technical and scientific information. As 

such, the material speech here in issue is appropriately entitled to full First Amendment 

protection and is not appropriately subjected to intermediate scrutiny that is the realm in which 

FTC speech regulation constitutionally occurs. See, e.g., Central Hudson Gas & Electric Corp. 

v. Public Service Commission of New York, 447 U.S. 557, 562 n. 5 (1980) (explaining that lesser 

constitutional protection is warranted for statements “made only in the context of commercial 

transactions,” because businesses “enjoy the full panoply of First Amendment protections for 

their direct comments on public issues”); Bolger v. Youngs Drug Products Corp., 463 U.S. 60, 

68(1983); Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 

626, 637-38 n. 7 (1985). 

Fully protected speech may not be the subject of government constraint unless the 

government can prove a compelling state interest and that the regulatory means are narrowly 

tailored (that is, the least restrictive means) to achieve the interest. See, e.g., Citizens United v. 
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Fed. Election Comm'n, 558 U.S. 310, 340 (2010). In this case, any order that would forbid use 

of the term biodegradable in reference to ECM additive infused plastics or would compel a level 

of proof beyond the credible evidence supplied in support of biodegradability in this case would 

constitute an overbroad regulatory intervention suppressive of speech for which there is no proof 

of falsity. Thus the means would not be narrowly tailored to achieve a substantial state interest 

in avoidance of deception in advertising. Moreover, there are obvious, less speech restrictive 

alternatives, such as reliance on claim qualification to reveal that rates of biodegradation vary 

depending on ambient environmental circumstances, which qualification, if reasonable, would be 

fully acceptable to ECM (indeed, has long been in use by the company). C.f. Am. Civil Liberties 

Union v. Mukasey, 534 F.3d 181, 204 (3d Cir. 2008) (holding that the Child Online Protection 

Act (COPA), which criminalized transmission over the Internet, for commercial purposes, of 

material “harmful to minors,” was not least restrictive alternative to advance government’s 

compelling interest in protecting minors from exposure to sexually explicit material because 

available filtering technology, which Congress could promote and support in place of COPA, 

was more effective at blocking sexually explicit material, and unlike COPA, did not chill 

speech). 

Although the speech here in issue fails to fall within either classic advertising or the 

context of commercial speech defined by the Supreme Court, if it is nevertheless deemed 

commercial because it, like a magazine, is loosely tethered to an ultimate purchase, any 

prospective order that would restrict future use of the claim of biodegradation on a demand for 

more proof than the credible evidence presented in this case would likewise offend the 

intermediate scrutiny standard applied in commercial speech cases. See, e.g., Zauderer, 471 U.S. 

at 637 (“The States and the Federal Government are free to prevent the dissemination of 
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commercial speech that is false, deceptive, or misleading, or that proposes an illegal transaction. 

Commercial speech that is not false or deceptive and does not concern unlawful activities, 

however, may be restricted only in the service of a substantial governmental interest, and only 

through means that directly advance that interest”) (citing Central Hudson, 447 U.S. at 566) 

(other internal citations omitted). 

ECM plastics are “biodegradable” under scientific definitions of the phrase in the peerreviewed literature.243 The addition of ECM’s product to conventional plastic polymers results 

in an end-product that will “biodegrade.” While rates of biodegradation vary, the evidence 

supporting biodegradation of ECM additive infused plastics is credible and, thus, protected 

commercial speech. See, e.g., Kiser v. Reitz, 13-3956, 2014 WL 4211193 (6th Cir. Aug. 27, 

2014) (“[C]ommercial speech is . . . constitutionally protected so long as it concerns lawful 

activity and is not misleading. . .”) (internal quotations omitted). 

Complaint Counsel contends that ECM’s truthful description of its product is misleading 

because a small group of consumers allegedly think the word “biodegradable” should mean that 

a product disappears completely within one year, albeit no competent evidence of that small 

group exists. Never mind that those consumers have no reasonable understanding of the term 

biodegradable. Never mind that the concept of 100% biodegradation of a product within one 

year is nearly impossible for most materials known to be rapidly biodegradable. Complaint 

Counsel maintains that industry should aspire to that unscientific and implausible standard, 

simply because some unreasonable consumers thinks it so. 

                                                             243 The dictionary also defines “biodegradable” as that which is “capable of being 

decomposed by bacteria or other living organisms.” ECM plastics have been shown capable of 

being decomposed and, so, the “biodegradable” claim is literally true. 
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Even assuming Complaint Counsel were correct, ECM’s biodegradable claim would only 

then be potentially misleading, not inherently misleading, because the claim is literally true even 

if it could potentially be misunderstood by unreasonable consumers expecting a scientifically 

impossible result. The Constitution prohibits restriction of potentially misleading speech when 

there are obvious, less speech restrictive alternatives to imposing prospective speech burdens. 

See, Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999). 

A burden on speech need not be a complete prior restraint in order to compel 

constitutional assessment under the commercial speech standard. See, e.g., Alliance for Natural 

Health U.S. v. Sebelius, 786 F. Supp. 2d 1, 24 (D.D.C. 2011) (“the FDA cannot require a 

disclaimer that simply swallows the claim . . .”). 

Rather, a cease and desist order that either prohibited use of the term “biodegradable” 

unless more than the credible evidence in this record was prospectively produced or unless 

confined to the impossible (such as a set rate within one year, despite the impossibility of 

reliably achieving same, or such as a demand for 100% break down of the plastic into elements 

in nature, despite the fact that science proves biodegradation of plastics inevitably leaves 

residues that still contain elements of plastic) would violate both the “reasonable fit” prong of the 

commercial speech test and the “obvious, less speech restrictive alternative” prong. See, e.g.,

City of Cincinnati v. Discovery Network, Inc., 507 U.S. 410, 417 (1993) (holding that ban on 

news racks containing “commercial handbills,” which did not apply to news racks containing 

“newspapers” was not a “reasonable fit” between city’s legitimate interest in safety and esthetics 

and means chosen to serve interest); Western States Medical Center, 535 U.S. 357, 371 (2002) 

(explaining that the Court has “in previous cases addressing this final prong of the Central 
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Hudson test, . . . made clear that if the Government could achieve its interests in a manner that 

does not restrict speech, or that restricts less speech, the Government must do so”). 

In particular, a cease and desist order that prohibits commercial speech that is backed by 

credible evidence on the demand that more evidence exist before government will allow the 

claim is a burden on speech already held unconstitutional by our Court of Appeals in Pearson v. 

Shalala and its progeny (and that, in a public health context). See, e.g., ANH, 786 F. Supp. 2d at 

24 (“Where the evidence supporting a [health] claim is inconclusive, the First Amendment 

permits the claim to be made . . .”). Moreover, there are obvious, less speech restrictive 

alternatives to satisfy government concerns that purchasers not be led to believe that claims of 

biodegradation imply either a rapid rate of disintegration or a complete return to elements in 

nature (no matter how absurd those assumptions may be in the present context) and that would 

be a claim qualification that advises purchasers that rates of biodegradation and the extent of 

biodegradation will vary depending on ambient environmental circumstances. A qualification of 

that kind would not be deemed objectionable by ECM but would be accepted (and is in fact akin 

to what ECM has long conveyed to its customers, RPFF ¶ 270). 

In Pearson I, the D.C. Circuit held that perceived deficiencies in the scientific record 

must be proven incapable of being rendered non-misleading by resort to reasonable claim 

qualifications before the government may resort to a prospective speech ban. See Pearson I, 164 

F.3d at 658 (holding that “[i]t is clear ... that when government chooses a policy of suppression 

over disclosure—at least where there is no showing that disclosure would not suffice to cure 

misleadingness—government disregards a ‘far less restrictive’ means”); see also Whitaker v. 

Thompson, 248 F.Supp. 2d 1 (D.D.C. 2002); Alliance for Natural Health U.S. v. Sebelius, 714 

F.Supp. 2d 48, 53 (D.D.C. 2010) (“ANH I”); Alliance for Natural Health U.S. v. Sebelius, 786 
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F.Supp. 2d 1, 8 (D.D.C. 2011) (“ANH II”). The same law and logic applies to FTC orders that 

restrain future speech through “fencing in” orders or other burdens. 

Although the government may have an interest in protecting consumers from misleading 

claims, that interest cannot overcome the First Amendment’s command for disclosure over 

suppression when claim qualification is a suitable, less speech-restrictive alternative. See 

Whitaker, 248 F.Supp. 2d at 10. As in this case, when “credible evidence supports a claim, that 

claim may not be absolutely prohibited.” See id. (citing Pearson I, 164 F.3d at 659). Moreover, 

significantly, “[t]he mere absence of significant affirmative evidence in support of a particular 

claim ... does not translate into negative evidence against it.” Pearson v. Shalala, 130 F.Supp. 

2d 105, 115 (D.D.C. 2001) (“Pearson II”); Edenfield v. Fane, 507 U.S. 761, 770 (1993) (“[I]t is 

well established that the party seeking to uphold a restriction on commercial speech carries the 

burden of justifying it”). Thus, in the penultimate case of ordering paragraphs, any cease and 

desist order requiring more proof than the credible evidence extant to permit prospective 

unmolested use of a biodegradable claim would be unconstitutional in light of the fact that the 

FTC has not, and cannot, meet its burden of proof under the First Amendment commercial 

speech standard. 

A government mandated claim qualification is constitutional only if it is reasonable. See, 

e.g. Whitaker v. Thompson, 248 F. Supp. 2d 1, 2 (D.D.C. 2002) (enjoining FDA from taking any 

action that would prevent the use of the antioxidant vitamin health claim at issue as proffered or 

with reasonable disclaimers). A mandated claim qualification that requires an affirmative 

statement of a set time or rate for biodegradation or for the achievement of 100% elimination of 

the plastic is scientifically infeasible and, in light of the inherent variability of the environment, 
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entirely impracticable, and, so, it fails constitutional muster under apposite precedent because the 

mandate is unreasonable. 

Unlike other FTC proceedings where the inherently misleading nature of speech 

overcomes the First Amendment analysis, the use of the “biodegradable” claim here is literally 

true and, at worst, only potentially misleading; thus the First Amendment trumps the attempt to 

prosecute the speaker and limit prospective speech. Accordingly, the complaint here in issue 

should be dismissed because no cease and desist and fencing in provisions may constitutionally 

be adopted. 

H. Complaint Counsel’s Enforcement Action Against ECM Is Not in the Public 

Interest 

Requisite to enforcement action, the Commission must determine whether there is a 

reason to believe that an unfair method of competition is being used, that the proceeding would 

be in the public interest, and that such interest is specific and substantial. See Federal Trade 

Commission v. Raladam Co., 283 U.S. 643 (1931). A proceeding by the Commission to prevent 

the use of unfair methods or unfair or deceptive acts or practices must appear to be in the interest 

of the public. Thomas v. FTC, 116 F.2d 347, 349 (10th Cir. 1940). In fact, the “commission is 

authorized to act only in the public interest, and to justify it in filing a complaint that public 

interest must be specific and substantial.” Arnold Stone Co. v. FTC, 49 F.2d 1017, 1019 (5th Cir. 

1931). The “mere misrepresentation and confusion or deception of purchasers” is insufficient for 

FTC action. FTC v. Royal Milling Co., 288 U.S. 212, 216 (1933). 

FTC precedent establishes that where a sophisticated entity, and not a consumer, makes 

the decision whether to purchase the product at issue, the respondent’s claims regarding that 

product cannot have any influence on the consumers, and therefore the public interest is not 
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served by requiring corrective action. In the Matter of Charles F. Harad, 50 F.T.C. 300, 315–

316 (1953). In Harad, the respondent claimed in a trade magazine that its product would be 

beneficial following patient surgery or after specific medical treatment. Id. at 315. Just as in this 

case, the experts in that case disagreed over whether or not the product was actually beneficial. 

Id. However, the hearing examiner found “it unnecessary to resolve th[at] difference of 

opinion.” Id. The court first noted that because it was the physician’s decision whether or not to 

purchase the device, the respondent’s claim could not have “any significant influence on the[] 

patients.” Id. In recommending dismissal of the complaint, the court then went on to state: 

In any event, since the representation made with respect to the ... use of the 

device was concededly made in a publication intended for circulation among 

physicians only, who, it can be assumed, will not be misled by anything 

respondents might say regarding their product, and since there is no 

substantial evidence that the general consuming public would be misled 

thereby, it is the opinion of the undersigned that the public interest does not 

require the taking of any corrective action based on the alleged falsity of any 

representation that respondents’ device may be used post-operation or postinjection. 

Id. at 315–16 (contrasting Irwin v. F.T.C., 143 F.2d 316 (8th Cir. 1944)) (where the 

respondent made claims regarding its product in “periodicals and by booklets, pamphlets, 

circulars, letters, and other advertising material”). 

Just like in Harod, here it is undisputed that ECM did not market its product directly to 

end use consumers. (RPFF ¶ 297). Rather, ECM, like the respondent in Harod made claims to 

entities interested in purchasing the product for commercial and not personal use, namely plastic 

manufactures. (RPFF ¶ 297). Whether or not to purchase the ECM additive is a decision left 

entirely to the plastic manufacturers that actually purchases the ECM additive. Like physicians 

determining whether to purchase a controversial medical device, plastic manufacturers are not 

misled by any marketing claims regarding additives used in the manufacture of plastics, which is 
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their specific profession and area of expertise. Therefore, “the public interest does not require 

the taking of any corrective action based on the alleged falsity of any representation that” that 

ECM made only to plastic manufacturers. Harad, 50 F.T.C. at 316. 

In addition, consider the FTC’s position that products which do not completely and 

totally biodegrade within one year cannot be labeled “biodegradable” without placing rate and 

extent qualifiers on the product that are likely infeasible to calculate with any accuracy. Because 

scientists cannot agree that there is a viable method to establishing the rate of biodegradation in a 

landfill (and Complaint Counsel has offered no such evidence), the FTC’s position favors rapidly 

degrading substances. Furthermore, by placing an emphasis on the speed at which a product 

biodegrades, the FTC has prioritized rapidly degrading technologies. Those same rapidly 

degrading products, however, actually harm the environment when deposited in a landfill. The 

more rapidly a product biodegrades, the less likely the landfill operator will be able to capture 

the methane gas emissions. Therefore, the rapidly degrading material is a net contributor to 

atmospheric methane gas after disposal, whereas the landfill has a much better chance of 

capturing (and perhaps applying to beneficial use) the methane emitted from a slowly degrading 

material. 

Yet despite those realities, Complaint Counsel is now enforcing through litigation a 

standard that favors rapidly degrading materials, in part, because the uniformed end-consumer 

erroneously believes that shorter is better when it comes to the disappearance of waste material. 

Similarly, Complaint Counsel has predicated critical components of its case on faulty and 

unscientific “consumer impression,” to wit, the existing of implied biodegradable rate claims. 

The consumer impression data is misleading and erroneous, having been obtained through 

flawed studies. The FTC lacked the opportunity to discover the varying understanding and belief 
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of consumers, which would have been essential in this area of complex scientific issues. (RPFF 

¶¶ 1110-1132). Complaint Counsel effectively replaces good science and judgment with the 

opinions of end-consumers, almost all of whom have no practical understanding of the detailed 

scientific concepts and debates. 

 There can be no consumer deception in an area where consumers so lack foundational 

bases to fully understand the concepts involved as to have no common net impression from the 

advertising message. The public interest is not served by having the Federal Trade Commission 

wade into areas of unsettled and complex science where the debate within industry and academia 

has yet to be resolved. See Koch v. FTC, 206 F.2d 311 (6th Cir. 1953). (“A principal test as to 

whether a particular case affects the public interest is whether the misleading or deception of the 

public is shown”). Here, as discussed above, there is no evidence that the public has been 

misled. 

In Arnold Stone, the Court held that action was not in the public interest or misleading 

because the FTC had failed to produce any evidence showing that a stone company’s use of the 

word “stone” deceived any of their sophisticated customers, even though the “stone” products 

sold were actually made of composite materials like concrete. Arnold Stone, 49 F.2d at 1018-19. 

Significant to this case, the Court explained that “none of the words employed by the petitioner 

to describe any of its manufactured products or materials had the effect of misleading or 

deceiving architects, contractors, or builders who were the only classes of persons to whom 

petitioner sold or offered to sell any such products or materials.” Id. The Court continued, “[t]he 

sum and substance of all the evidence was that the words ‘cast stone’ were understood by 

petitioner’s prospective customers and by its competitors to mean just such a product as 

petitioner manufactured and sold.” Id. So too, here, ECM’s sophisticated plastics customers, 
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who are the only classes of persons to which ECM sells its additive, were seeking just 

“biodegradable” plastics, and that is exactly what they received. (RPFF ¶ 606–09, 620–25, 636–

37, 647, 657–58, 661–62, 677–79, 694-95, 704, 706, 712–14). There is no evidence that ECM’s 

customers desired any specific rate of biodegradation, or that biodegradation rate (even if 

changed) would have influenced their purchasing decisions. (RPFF ¶¶ 605–609, 613–16, 620–

25, 633–35, 644–46, 653–56, 664–65, 673–76, 689–92, 700-03, 707, 710, 717–23). If ECM’s 

customers cared at all about the “rate” of biodegradation, it was because they needed to be sure 

that the product would last long enough on the shelf, or because they were aware that the FTC 

demanded a rate. (RPFF ¶¶ 309–10, 724-–25). There is thus no evidentiary record in this case to 

show that action on ECM rate claims (or lack thereof) is at all in the public interest. 

Having the FTC set environmental policy determinations within the context of a 

consumer deception/protection is not in the public interest, particularly when, as here, there are 

largely no actual commercial sales to end-consumers. That begs the question, if the FTC 

jurisdiction is limited to activity that affects commerce, who is the FTC protecting in this case? 

It is unclear if Complaint Counsel fully comprehends the answer to that question. 

 Underlying this entire discussion is the fact that a more slowly biodegrading product is 

actually better for the environment than a product that would disappear within, say, five years. 

(Barlaz, Tr. 2287–90). “[T]here must be a showing that the acts and practices sought to be 

proscribed are detrimental to the public interest in order to satisfy the statutory requirement that 

the proceeding be in the public interest.” S. Buchsbaum & Co. v. FTC, 160 F. 2d 121, 123–24 

(7th Cir. 1947). That fact was dispositive in the Buchsbaum case, as the Court explained: 

[T]he Commission made no finding that the deception, if any, had ever 

resulted in or had any tendency to result in detriment to the purchasing public. 

We find nothing in the findings to support the conclusion that the acts and 

practices are all to the prejudice and injury of the public. 
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Id. at 123-24. This ECM case is similar to the Buchsman case, where the FTC challenged a 

company making shatterproof “glass” products because, according to the FTC, the “glass” was 

actually made out of plastic. Id. at 123. The Court observed that, just like in this case where 

ECM can undercut the prices of the more expensive bioplastics: 

It is quite evident that [the] proceeding was actuated by the manufacturers of 

[competing] glass as contained in window panes, tumblers and the like. The 

trouble arises in trying to compete with petition in the sale of the same articles 

made of ‘Elasti-Grass’ by petition. Thus far, it appears from the record, the 

competition has not been successful for such manufacturers, because of the 

cheaper prices of petitioner’s products. 

Id. at 124. The ECM case is not substantially different from the Buchsbaum case. Complaint 

Counsel alleges that the word “biodegradable” has a specific meaning (just like “glass” had a 

meaning in Buchsbaum), and that customers will be misled into thinking the “biodegradable” 

plastic is of a specific kind, to wit, a kind that rapidly degrades. In Buchsman the Court rejected 

that very type of case for the same reasons this Court should deny Complaint Counsel relief: 

“We find in this record no evidence of any injury to any dissatisfied customer, indeed, there are 

no dissatisfied customers so far as this record discloses.” Id. at 123. The Court also wisely 

acknowledged that any theorized injury could be alleviated through a more proactive consumer: 

It is intimated that the injury will occur to those who have been ‘long 

accustomed to the worth and use of glass.’ If this class of customers would 

consult their lexicons and inform the merchants as to the kind of glass they 

desire they will never be misled. Certainly they can not be misled or injured 

by petitioner’s advertisements. 

Id. at 123. As the precedent makes clear, Complaint Counsel is obliged to identify some tangible 

or palpable injury in the market in order to establish that this case is in the public interest. They 

have not done so, and they cannot do so with this record. 
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I. The FTC’s Suggested Remedy Is Unlawful and Unsupported by the Facts 

1. The FTC’s Proposed Order Requires Proof of a “Rate” for 

Biodegradation When There Is No Competent and Reliable Evidence to 

Prove Any Set Rate 

Logically, if Complaint Counsel would require a specific “rate” of biodegradation to 

qualify “biodegradable” claims, e.g., one year, Complaint Counsel must demonstrate what type 

of evidence, if any, ECM must rely on to prove satisfaction of that one year rule. (RPFF ¶¶ 

1581–1605). Complaint Counsel has been unable to produce that evidence. (RPFF ¶¶ 1581–

1605). In fact, no witness in this case (including Complaint Counsel’s witnesses) has testified 

that it is possible to make a “rate” claim due to the variable environmental conditions that affect 

rate. (RPFF ¶¶ 1581–1605). Dr. Barlaz testified that there is no generally accepted method to 

calculate rate of biodegradation in landfills, in part, because the rates fluctuate so substantially 

based on the environmental conditions of disposal. (Barlaz, Tr. 2281–83). 

The relief requested by Complaint Counsel, to wit, a specified “rate” of biodegradation in 

advertisements, is therefore not a scientific possibility. The lack of evidence showing how a 

company could potentially meet Complaint Counsel’s requirement is therefore problematic and 

objectionable on at least two grounds. First, if there is no scientific consensus with respect to 

establishing a uniform “rate” of biodegradation, then ECM cannot logically comply with 

Complaint Counsel’s proposed relief, and the relief is therefore a total bar to ECM’s 

biodegradable claim. ECM would risk making a “rate” claim that is both deceptive and 

unsubstantiated, as Dr. Barlaz has explained that “it’s very, very difficult to measure rates at 

either – at field scale either for individual components or for bulk waste...” (Barlaz, Tr. 2282). 

Moreover, even assuming that a “rate” of biodegradation could be established through evidence 

that would somehow satisfy Complaint Counsel, that “rate” would inherently mislead, because 
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the record is clear that the rate itself depends on many variables, and it will fluctuate drastically 

depending on the ambient environmental conditions even within a single landfill. (RPFF ¶¶ 

1640–45, 1713, 1723, 2807–09). The rates of biodegradation also depend on the characteristics 

of each specific plastic, including the crystallinity of plastics (which is a characteristic developed 

through the manufacturing process and unique to each plastic batch, like a fingerprint). (RPFF 

¶¶ 1640–45, 1713, 1723, 1749–65, 2807–09). Predicting even a conservative rate would be 

impossible or misleading, because there may be sterile areas within MSW landfills where even 

the most biodegradable materials will not biodegrade. (Sahu, Tr. 1769). Finally, Complaint 

Counsel has not explained how a laboratory test could “simulate” or “replicate” landfill 

environments such that the data gleaned from a laboratory test could be extrapolated into the 

landfill for the purpose of calculating “rate.” (RPFF ¶ 1885). Complaint Counsel’s witnesses 

struggled with that concept. (RPFF ¶¶ 2721–23, 2753–62, 2773–80). 

Second, because Complaint Counsel’s proposed qualifier is scientifically impossible, the 

relief will violate the First Amendment. The FTC’s required disclaimer in its proposed order (¶ 

4.B) is scientifically incompetent and also infeasible; thus, adoption of it would serve as a fully 

effective prior restraint on all future biodegradable claims in this market. That restriction would 

be overbroad and in violation of the Pearson I doctrine. 164 F.3d 650 (D.C. Cir. 1999). More 

particularly, the proposed relief precludes the truthful and obvious claim that the “rate” of 

biodegradation is uncertain and depends on many intrinsic and extrinsic factors, including the 

composition of the plastic and the environmental conditions following disposal. That latter 

statement, which is scientifically accurate and non-misleading, would be mutually exclusive to 

the qualification required under Complaint Counsel’s proposed order.
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2. Complaint Counsel has Failed to Prove That the “Extent” of 

Biodegradation is Relevant to a Consumer Claim 

Complaint Counsel’s proposed Order in Paragraph 4.B would alternatively require ECM 

to specify the “extent” to which a product is biodegraded within a certain period of time. As 

with the “rate” qualifiers suggested by Complaint Counsel, there is no evidence in the record to 

establish how a company could predict the “extent” of biodegradation given the many 

environmental variables that affect rate. It is decidedly the case that a biodegradable plastic will 

necessarily biodegrade at a different rate in one location than the next and even in different 

locations within the same landfill. (RPFF ¶¶ 1581–1605, 1640–45, 1713, 1723, 2807–09). 

Moreover, all experts agree that even the most “biodegradable” substances, like cellulose 

or food waste, may not completely biodegrade under certain environmental conditions. (RPFF 

¶¶ 2833–34, 2985, 2990; Sahu, Tr. 1767–69). Yet that does not affect whether the material is 

“biodegradable” from a scientific perspective. (Barlaz, Tr. 2217–19). Complaint Counsel’s 

proposed relief would therefore apply an unscientific and infeasible standard to the 

“biodegradable” claim with respect to ECM plastics which is not logical or consistent with the 

scientific understanding of “biodegradability.” In the scientific community, the “extent” and 

“rate” of biodegradation are not relevant because they are uncertain and unpredictable. (RPFF ¶¶ 

1581–1605, 1593, 1640-45, 1713, 1723, 2807–09). 

3. Complaint Counsel’s Proposed Order Is Vague and Ambiguous, and It 

Would Impose Unworkable Standards 

The two operative standards in Complaint Counsel’s Proposed Order (¶ 4.B) require an 

advertiser to prove that a plastic product will “completely decompose into elements found in 

nature” within “stated timeframe,” and the testing used to support those claims must “replicate” 
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or “simulate” the physical conditions found in the type of disposal facility or method stated in the 

representation.” Id. This requirement is scientifically incompetent and entirely impracticable 

because, as stated above, there is no universal time frame provable for any biodegradable plastic 

and there is no biologically homogenous landfill environment; landfills are biologically 

heterogeneous by their very nature. (RPFF ¶¶ 1581–1605, 1593, 1640–45, 1713, 1723, 2807–

09). As discussed supra at 198, Complaint Counsel has offered no evidence explaining what 

type and quality of evidence an advertiser could feasibly generate to support the rate and extent 

claims, while maintaining a perfectly “replicated” test environment. The Order would thus 

require more than Section 5 of the FTC Act requires to avoid deception and would substantively 

effect an absolute prior restraint or complete prospective speech ban on biodegradable claims. 

See, e.g., In the Matter of Pom Wonderful LLC, 9344, 2012 WL 2340406 (F.T.C. May 17, 2012) 

(at 324) (citing Daniel Chapter One, 2009 FTC LEXIS 259, at *70)). 

First, Complaint Counsel has provided no evidence concerning how a product can be 

classified as having “completely decompose[d] into elements found in nature.” The evidence 

suggests that the amount of a product that is converted through biodegradation to gas versus the 

smaller amounts converted to humus and other recalcitrant portions varies considerably. (RPFF 

¶¶ 2989–90). In fact, Complaint Counsel’s rebuttal witness, Dr. Michel, testified that even 

cellulose (a material generally accepted to be “biodegradable”) can degrade anywhere between 

44% to 100% and still be considered “fully” biodegraded at those respected amounts. (RPFF ¶¶ 

2989–90). The point at which a material could be said to have “fully” biodegraded is therefore 

vague and ambiguous, and, so too, is the phrase “complete” biodegradation or decomposition. 

Complaint Counsel and their experts have not attempted to support paragraph 4.B of their 
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proposed order with any evidence showing how the scientific or consumer community would 

understand the terminology, which is complex and controversial. 

Second, Complaint Counsel has not provided evidence to support the position that 

biodegradable testing can “simulate” or “replicate’ the conditions found in a typical landfill, 

while remaining at all practical or feasible. In fact, Complaint Counsel’s witnesses were unable 

to even define what constitutes “typical” landfill conditions, or explain how an “accelerated” 

biodegradation test (which is generally accepted) could similarly “simulate” the conditions in 

every landfill. However, Complaint Counsel’s proposed order (Complaint, at 12) would require 

ECM to test under conditions that “simulate” the physical conditions “found in landfills.” What 

are those conditions? If anything, the record shows that the conditions are highly variable and 

heterogeneous, making the characterization of a “typical” landfill nearly impossible. (RPFF ¶¶ 

1581–05, 1593, 1640-45, 1713, 1723, 2807-09). 

Thus, Complaint Counsel’s theories with respect to testing that “simulates” landfills are 

unsupported by the evidence and the relevant science, which includes testimony given by 

Complaint Counsel’s own witnesses. (RPFF ¶¶ 1581–1605, 1593, 1640–45, 1713, 1723, 2807–

09). 

J. Complaint Counsel’s Case Against ECM Constitutes Ultra Vires Agency 

Action and Is an Assumption of Regulatory Power Vested Not in FTC, but in 

the EPA 

Government action is ultra vires if the agency or other government entity “is not doing 

the business which the sovereign has empowered him to do or he is doing it in a way which the 

sovereign has forbidden.” Ancient Coin Collectors Guild v. U.S. Customs & Border Prot., Dep't 

of Homeland Sec., 698 F.3d 171, 179 (4th Cir. 2012) (quoting Larson v. Domestic & Foreign 

Commerce Corp., 337 U.S. 682, 689 (1949)). Courts review ultra vires agency action when an 
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agency “patently misconstrues a statute, disregards a specific and unambiguous statutory 

directive, or violates a specific command of a statute.” Hunter v. F.E.R.C., 569 F. Supp. 12, 16–

17 (D.D.C. 2008). Put differently, “[a]n ultra vires act is one performed without any authority to 

act...” Sahaviriya Steel Industries Public Co. Ltd. v. U.S., 601 F. Supp. 2d 1355, 1366 (C.I.T. 

2009). The Administrative Procedures Act (APA) further contemplates that agency action is 

void if found to be “in excess of statutory jurisdiction, authority, or limitations, or short of 

statutory right.” See 5 U.S.C. § 706 (2)(C). 

Complaints Counsel’s definition of “biodegradable,” which limits the naked term to 

products that completely degrade, returning to elements found in nature, within one year, is 

patently arbitrary and capricious and in conflict with environmental policies set by the federal 

Environmental Protection Agency. Because through an order prohibiting use of the term 

biodegradation on ECM’s product for which there is credible scientific evidence of 

biodegradation, the FTC has effectively altered national environmental policy. Beyond 

adjudication of false or misleading advertising, the FTC has acted ultra vires and in excess of its 

statutory authority by establishing a market definition for biodegradation that differs 

fundamentally from what the scientific community and the EPA regard as biodegradable 

products that contribute to waste management. By effectively removing the market identifier 

“biodegradable” from slowly degrading landfillable products, the FTC necessarily alters national 

policy set by the EPA that, contrary to that FTC action, discourages promotion of rapidly 

degrading plastics, resulting in greater adverse environmental consequences through the 

production of more greenhouse gas emissions, as explained above. (RPFF ¶¶ 1596–1605). 

The U.S. EPA has primary responsibility for enforcing the environmental statutes and 

regulations of the United States. 42 U.S.C. § 6901. Under the federal Resource Conservation 
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and Recovery Act (RCRA), Congress delegated to the EPA the task of managing solid waste 

disposal. See, e.g., 42 U.S.C. § 6901. Congress passed the RCRA, in part, to address the “evermounting increase ... of the mass material discarded by the purchaser of ... products.” 42 

U.S.C. § 6901(a)(1). Moreover, concerning energy, Congress explained that “solid waste 

represents a potential source of solid fuel, oil, or gas that can be converted into energy.” 42 

U.S.C. § 6901(d)(1). 

ECM experts testified that U.S. landfills have become a major source of harvestable 

natural gas in the form of methane emissions. (RPFF ¶¶ 1846–61). The major byproduct of 

biodegradation in landfills is methane and carbon dioxide gas. Methane is released as a result of 

the biodegradation process as microorganisms in the landfill disassemble carbon bonds from the 

solid waste, often through enzymatic digestion. Methane is formed with one carbon atom and 

four hydrogen atoms. As experts explained in this case, many modern landfills, operated under 

the auspices of the EPA and local regulations, are now designed to harvest gases emitted from 

landfills in conformity with national environmental regulations established by the EPA. (RPFF 

¶¶ 1598–99). For instance, 1 million tons of waste within a landfill generally creates 550,000 

cubic feet per day of landfill gas, or one megawatt of electricity, which is enough to power 700 

homes for one year. (RX 967). Moreover, by collecting and using those methane emissions for 

beneficial use, the landfill operators remove methane gas from the atmosphere equal to taking 

about 8,800 cars off the road for a year. (RX 967). 

Rapidly degrading waste is inconsistent with the ideals for the operation and maintenance 

of landfills. (RPFF ¶¶ 1593–1605). Landfills pass through several phases in their life cycle. In 

the first phase, the landfill is open and accepting waste into “cells.” During that period there is 

both anaerobic and aerobic activity. However, the systems designed for landfill gas collection 
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are not active or functional during the open phase of landfill cells. Traditional landfill gas 

collection models are usually not equipped to collect gas emissions for two years. (RPFF ¶ 

1599; RX 853, at 12). Thus, products that rapidly degraded within one year would cause 

methane gas to be released directly into the atmosphere, contributing to atmospheric greenhouse 

gases where they would otherwise be collected or flared. (RPFF ¶ 1600). 

Dr. Morton Barlaz is one of the nation’s leading experts in environmental sciences with 

respect to MSW landfills and biodegradation. (RPFF ¶¶ 182–200). Complaint Counsel’s 

purported landfill expert, Dr. Tolaymat, recognized Dr. Barlaz as an authority in the field and 

would defer to Dr. Barlaz. (RPFF ¶¶ 2724–27). Dr. Barlaz testified that increasing the rates of 

biodegradation for landfilled products is antithetical to the EPA goals of gas collection and are 

detrimental to the environment. (RPFF ¶¶ 1593–1605). He testified that more rapidly degrading 

substances in landfills provide no appreciable environmental benefit, in part, because landfilled 

products are intended for nearly infinite storage, and landfill sites expect to provide same. He 

explained that plastic products that degrade in an MSW landfill within a matter of decades are 

preferable, and that decades would be a reasonably short period of time for degradation based on 

scientific principles. (RPFF ¶¶ 1593–1605). 

It is decidedly within the enabling statute of the EPA for that agency, and not the FTC, to 

effect national environmental policy as it pertains to biodegradable plastics in landfills. Acts by 

the FTC to misidentify in the market products that effect biodegradation over periods greater 

than a year and instances where the products do not biodegrade 100% by returning to elements 

within nature before the passage of a year conflict directly with national environmental policy as 

set by the EPA which favors the gathering and conversion of greenhouse gas emissions from 
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slowly biodegrading products rather than rapidly biodegrading ones favored by the FTC’s 

biodegradation and compostable product rules. (RX 967; RPFF ¶¶ 1593–1605). 

Government action is ultra vires if the agency or other government entity “is not doing 

the business which the sovereign has empowered him to do or he is doing it in a way which the 

sovereign has forbidden.” Ancient Coin Collectors Guild v. U.S. Customs & Border Prot., Dep't 

of Homeland Sec., 698 F.3d 171, 179 (4th Cir. 2012) (quoting Larson v. Domestic & Foreign 

Commerce Corp., 337 U.S. 682, 689 (1949)). “An ultra vires act is one performed without any 

authority to act...” Sahaviriya Steel Industries Public Co. Ltd. v. U.S., 601 F. Supp. 2d 1355, 

1366 (C.I.T. 2009). The Administrative Procedures Act (APA) further contemplates that agency 

action is void if found to be “in excess of statutory jurisdiction, authority, or limitations, or short 

of statutory right.” See 5 U.S.C. § 706 (2)(C). When agencies of the government adopt rules 

that trench upon a regulatory province delegated to a sister agency, the action is considered 

unlawful because it is ultra vires. 

K. The “One-Year” Rule Is An Unlawful Industry-Wide Trade Regulation Rule 

The “One-Year” Rule promulgated in the 2012 revision of the Green Guides is not an 

interpretative, non-binding statement of policy, but an industry-wide rule that redefines scope of 

products that can be marketed. The rule favors short-term degradable products to the prejudice 

of those products that would biodegrade slowly in a landfill, but still within a reasonably short 

period of time compared to conventional plastics. Furthermore, because Complaint Counsel has 

explained through this proceeding that no test can accurately substantiate the time for disposal in 

an MSW landfill, and the rule expressly states that it is “deceptive to make an unqualified 

degradable claim for items entering the solid waste stream if the items do not completely 
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decompose within one year after customary disposal,” the Green Guides prohibit technologies 

that do not, in fact, disappear in landfills within one year. See 16 C.F.R. § 260.8(c). In other 

words, the Commission has condemned the use of landfill-able technologies in toto. That is an 

environmental policy that says landfill-able products are not desirable—not a position with 

respect to consumer deception. The FTC has thus enacted a new industry-wide rule equivalent to 

the FDA’s prior restraint the United States Court of Appeals condemned as unconstitutional in 

Pearson I. See Pearson I, 164 F.3d at 655–60. 

15 U.S.C. § 57 requires that FTC proceed through Magnuson-Moss rulemaking when 

promulgating rules defining practices which are unfair or deceptive. See 15 U.S.C. § 57a 

(requiring heightened procedural safeguards in FTC rulemaking proceedings); see also 5 U.S.C. 

§ 553 (requiring federal agencies, with limited exceptions, to follow notice-and-comment 

rulemaking procedures when promulgating a new rule, regulation, or interpretation of a 

regulation). Because the Commission has not complied with all of the requirements of Section 

57a (in particular, Section 57a(b)(2)), the trade regulation rule implemented and now enforced 

against ECM is unlawful and should be given no weight in this proceeding.244

                                                             244 For example, because the FTC did not properly characterize the industry rule as a 

Trade Regulation Rule under Section 57a, the Commission did not apparently notify and seek 

input from the Committee on Commerce, Science, and Transportation of the Senate and the 

Committee on Energy and Commerce of the House of Representatives. See 15 U.S.C. § 

57a(b)(2). 
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L. Complaint Counsel’s Case Against ECM Violates Due Process 

1. The FTC Proceedings Violate the Separation of Functions Doctrine 

Due Process is required in administrative proceedings. See Withrow v. Larkin, 421 U.S. 

35, 46 (1975); Utica Packing Co. v. Block, 781 F.2d 71, 76 (6th Cir. 1986). Under 5 U.S.C. § 

556 of the Administrative Procedures Act, Congress requires administrative agencies to conduct 

hearings mandatory under §§ 553 and 554 “in an impartial manner.” 5 U.S.C. § 556. “A fair 

trial in a fair tribunal is a basic requirement of due process. Fairness of course requires an 

absence of actual bias in the trial of cases. But our system of law has always endeavored to 

prevent even the probability of unfairness." In re Murchison, 349 U.S. 133 (1955). As the D.C. 

Circuit has stated: “With regard to judicial decision making, whether by court or agency, the 

appearance of bias or pressure may be no less objectionable than the reality.” D.C. Federation of 

Civic Ass'ns v. Volpe, 459 F.2d 1231, 1246–47 (D.C. Cir. 1971), cert. denied, 405 U.S. 1030 

(1972).

“When governmental agencies adjudicate or make binding determinations which directly 

affect the legal rights of individuals, it is imperative that those agencies use the procedures which 

have traditionally been associated with the judicial process.” Utica Packing, 781 F.2d at 78. In 

administrative proceedings, “the requirement of a fair trial before a fair tribunal has not been 

eliminated. This concept requires the appearance of fairness and the absence of a probability of 

outside influences on the adjudicator; it does not require proof of actual partiality.” Id. at 76 

(citing Withrow, 421 U.S. at 35). 

In order to enforce this separation of functions and impartiality in administrative 

hearings, Congress included 5 U.S.C. § 554(d) in the APA. That statute restricts the 

investigator/prosecutor from being involved in the decision making process. “The clear purpose 
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of [5 U.S.C. § 554(d)] is to separate the investigative and prosecutorial functions from the 

adjudicative function” in administrative hearings. Utica Packing, 781 F.2d at 76 (citing Wong 

Yang Sung v. McGrath, 339 U.S. 33, 41 (1950)). Section 556(d) (5 U.S.C. § 556(d)) cannot be 

read narrowly. Id.

In this case, ECM is in danger of losing an important legal right without traditional 

judicial process. Indeed, unlike other companies prosecuted by the FTC for alleged violations of 

the Green Guides, ECM is at risk of losing its right to effectively market the only product it 

sells—the ECM additive. (RPFF ¶ 41). Complaint Counsel, through the Green Guides and 

through this litigation, intends to prohibit ECM from making any unqualified “biodegradable” 

claim. See In re ECM Biofilms, Complaint, at 12. Without the ability to effectively market its 

only product, ECM will, of course, go out of business. ECM is willing to make reasonable 

qualifications of its biodegradable claim. (RPFF ¶¶ 314–15). However, the qualifications 

Complaint Counsel demands—namely that ECM state how long each plastic product containing 

the ECM additive will take to biodegrade—is simply impossible. (RPFF ¶¶ 1581–1605, 1593, 

1640-45, 1713, 1723, 2807-09). ECM does not know and cannot not know all of the plastic 

products that are manufactured with the ECM additive. Further, the rates of biodegradation of 

plastics containing the ECM additive vary greatly depending on the environment in which the 

product ultimately comes to rest. (RPFF ¶¶ 1581–1605, 1593, 1640–45, 1713, 1723, 2807–09). 

The FTC is the judge, jury, and executioner in this case. The only “trial” available is 

before the ALJ—an adjudicatory body with no authority to issue a final decision. After a 

decision is reached by the ALJ, the decision is submitted to the FTC commissioners for de novo 

review, yet the Commission is the charging party because it has approved the staff’s Complaint 

for issuance to the respondent. 16 C.F.R. § 3.11(a). If the Commission does not agree with the 
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ALJ, the Commission is free to overturn the decision and create a ruling as it so chooses. This 

system does not give individuals sufficient due process in situations, where, as here, entire 

companies and livelihoods are wholly at risk. ECM was afforded the right to argue its position 

before a neutral referee, but the ultimate decision maker—the Commission—was not present to 

evaluate the arguments or the testimony offered by the parties and is in fact the ultimate charging 

party. While the Commission is obligated to acknowledge the ALJ’s findings, there is no 

requirement that the Commission give those findings any weight. The Commission brought the 

allegations against ECM and will be the ultimate adjudicator against ECM. Thus, the 

Commission necessarily has an interest in the outcome sufficient to violate the doctrine of 

separation of functions. See Leer Elec., Inc. v. Penn. Dep’t of Labor and Indus., 597 F. Supp. 2d 

470, 481 (M.D. Pa. 2009) (noting that the officials’ multiple roles as investigators, prosecutors, 

and adjudicators were sufficient to present a risk of actual bias). 

2. Complaint Counsel’s Abusive Discovery Practices 

In this proceeding, Complaint Counsel failed to produce documents responsive to ECM’s 

requests of considerable import in this action.245 This Court Sanctioned Complaint Counsel for 

failing to disclose information to ECM that was later used against ECM’s principles in 

depositions through a planned “gotcha” moment.246 That document was Dr. Michel’s analysis of 

several competing biodegradable technologies. Although Dr. Michel has been an FTC 

consulting witness since 2012, Complaint Counsel feigned any knowledge of his work, but when 

ECM subpoenaed Dr. Michel for information concerning his study, Complaint Counsel 

                                                             245 See In re ECM Biofilms, Order Granting in Part and Denying in Part Respondent’s 

Motion for Sanctions, Dkt. No. 9358 (Mar. 21, 2014). 

246 Id. at 6. 
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intervened and instructed him not to timely respond to ECM’s non-party subpoena.247 Those 

acts are illegal, as they deprived ECM of the documents in question and thereby violated ECM’s 

basic right to Due Process.248 Courts have long held far less subtle attempts by party opponents 

to dissuade subpoena response to be sanctionable conduct in violation of the Due Process rights 

of the movant. See, e.g., Price v. Trans Union, LLC, 847 F.Supp. 2d 788, 794 (E.D. Pa. 2012). 

Complaint Counsel has also escalated costs in an effort to limit ECM’s defense. The cost 

of Complaint Counsel’s erratic, meandering and ill-timed discovery practice has been 

considerable.249 Complaint Counsel has performed twenty (20) fact depositions of testing 

laboratories and ECM customers all over the country, in Hawaii, California, New York, Ohio, 

and the District of Columbia, to name a few.250 Those depositions included the following 

persons and entities: 

 Northeast Labs (May 9, 2014) (in New Haven, CT) 

 BER Plastics (May 8, 2014) (in New York, NY) 

 D&W Fine Pack, LLC (May 5, 2014) (in Washington, DC) 

 Down to Earth (Apr. 29, 2014) (in Honolulu, HI) 

 Eagle File Extruders (May 14, 2014) (in Grand Rapids, MI) 

 Eden Labs (May 19, 2014) (in Albuquerque, NM) 

                                                             247 See In re ECM Biofilms, Order Denying Respondent’s Motion for Sanctions for 

Unauthorized Dissuasion of Response to Subpoena Duces Tecum, Dkt. No. 9358 (Apr. 9, 2014). 

248 See Chambers v. Mississippi, 410 U.S. 284 (1973) (due process affords parties the 

right to introduce certain evidence); Epstein v. MCA , Inc., 54 F.3d 1422 (9th Cir. 1995) (the 

federal rules ordinarily contemplate a “broad right of discovery”); Berger v. United States, 295 

U.S. 78, 88 (1935) (“[The Government] is the representative not of an ordinary party ... but of a 

sovereignty ... whose interest is not that it shall win cases, but that justice be done”) (emphasis 

original). 

249 The transcripts alone in this case cost over $1,000 per document. Other costs include 

attorney fees, costs of travel and lodging, and document costs. 

250 By contrast, to eliminate extraordinary burden, the Federal Rules of Civil Procedure 

generally prohibit a party from seeking more than ten (10) depositions. See Fed. R. Civ. Pro 

30(a)(2)(A)(i). Parties seeking to expand that number must justify the necessity of each 

deposition. See, e.g., Archer Daniels Midland Co. v. Aon Risk Services, Inc. of Minnesota, 187 

F.R.D. 578, 586 (D.Minn. 1999) (collecting cases). 
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 Elsevier (May 30, 2014) (telephonic) 

 Flexible Plastics (May 15, 2014) (in St. Paul, MN) 

 Island Plastic Bags (April 28, 2014) (in Honolulu, HI) 

 Kappus Plastic Company (May 6, 2014) (in New York, NY) 

 Quest Plastics (May 7, 2014) (in New Haven, CT) 

 3M Corporation (May 16, 2014) (in St. Paul, MN) 

 ANS Plastic (May 5, 2014) (New York, NY) 

 FP International (May 1, 2014) (in San Francisco, CA) 

 Timothy Barber, Ph.D. (May 7, 2014) (in Cleveland, OH) 

 Thomas Nealis, ECM Employee (March 5, 2014) (in Painesville, OH) 

 Alan Poje, former ECM Employee (March 6, 2014) (in Painesville, OH) 

 Robert Sinclair, ECM President (February 18, 2014) (in Painesville, OH) 

 ECM Biofilms (February 19, 2014) (in Painesville, OH) 

 Kenneth Sullivan, ECM Officer (February 20, 2014) (in Painesville, OH) 

Each of the foregoing depositions were noticed and conducted by Complaint Counsel. 

Also, Complaint Counsel noticed and took five additional expert depositions, bringing their total 

for the case to twenty four (25) total depositions in its case against ECM, which has just six total 

employees and two officers: 

 Dr. Ron Sahu (June 30, 2014) (in Los Angeles, CA) 

 Dr. David Stewart (July 1, 2014) (in Los Angeles, CA) 

 Dr. Ryan Burnette (July 2, 2014) (in Washington, DC) 

 Dr. Morton Barlaz (July 14, 2014) (in Raleigh, NC) 

 Dr. Sasha Volokh (July 15, 2014) (in Atlanta, GA) 

The burdens and costs associated with the many fact depositions forced ECM to appear 

unrepresented, or have counsel appear telephonically at a distinct disadvantage. Knowing that 

ECM could not appear at the depositions themselves, or entered limited telephone appearances, 

Complaint Counsel relies exclusively on the transcripts from those very depositions in lieu of 
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live witness testimony, thus ensuring that ECM lacks an opportunity to perform any meaningful 

cross-examination of witnesses Complaint Counsel will rely upon at trial. 

Complaint Counsel’s many fact depositions also created an in terrorem effect in the 

market as ECM’s customers fear FTC enforcement. On October 29, 2013 the FTC announced 

six enforcement actions against companies, including ECM, for violating the revised Green 

Guides and the One Year Rule.251 The FTC has already secured two consent orders from ECM 

former customers. Parties participating in depositions have been forced to disclose their business 

records to the FTC. Those customers now reasonably fear FTC action, which renders them more 

willing to please the FTC and offer testimony unfavorable to ECM and less willing to do 

business with ECM. 

Knowing that ECM was unable to provide live counsel during depositions of ECM 

customers, Complaint Counsel lead witnesses excessively, effectively testifying for those 

witnesses through counsel’s questions.252 

 Complaint Counsel now presents that testimony in written form only, where ECM lacked 

the ability to cross-examine the witnesses, and the Court cannot make assessments of witness 

credibility, or determine (crucially) whether the manner and format of Complaint Counsel’s 

questions influenced the witnesses’ testimony. Complaint Counsel essentially asks the Court to 

take these witnesses’ statements at face value. 

It is axiomatic to basic notions of Due Process that at trial all fact witnesses whose 

testimony may be relied upon if available to testify be called at hearing, be subjected not only to 

direct but also cross examination, and be witnessed in their demeanor by the presiding judge who 

                                                             251 http://www.ftc.gov/news-events/press-releases/2013/10/ftc-cracks-down-misleadingunsubstantiated-environmental 

252 See, e.g., CCX 811 (Hong, Dep. at 33–38). 
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may, on that basis, evaluate the character and credibility of the testifying witness. Out of court 

statements thus lack the reliability and completeness required to be credited at trial because they 

are not subjected to the crucible of cross or the direct examination of the fact finder.253

 Accordingly, this Court should give no dispositive weight to any content in the transcripts 

of fact witnesses relied upon by Complaint Counsel who did not appear as witnesses at trial. 

Moreover, this Court should find that ECM’s due process rights have been violated by 

Complaint Counsel’s interference with subpoenas in this case and establish a clear precedent to 

prohibit similar conduct in future. 

3. Unfair Surprise 

Although having been aware of Dr. Michel’s study of ECM plastic (and other 

commercial plastics since Complaint Counsel contracted with Dr. Michel in 2012, in this case 

Complaint Counsel elected not to list Dr. Michel as a witness on any of their proposed witness 

lists. Despite having five (5) distinct opportunities in the case to list Dr. Michel as a witness, 

Complaint Counsel never suggested he would testify in any capacity. Complaint Counsel even 

secured a stipulated agreement with ECM’s counsel to preclude Dr. Michel’s deposition 

testimony on the basis that he would not be called as a fact witness. Meanwhile, Complaint 

Counsel took a number of actions to bolster Dr. Michel’s anticipated testimony, including taking 

the deposition of Elsevier, the company that staffed the reviewer for Dr. Michel’s article. 

                                                             253 See, e.g., Prebble v. Brodrick, 535 F.2d 605, 616 (10th Cir. 1976) (where information 

from persons not present at hearing concerns an important issue in dispute, a due process 

objection may well be valid). 
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Complaint Counsel eventually listed Dr. Michel as a rebuttal witness only, and the 

testimony offered in Dr. Michel’s “rebuttal” report was information that could have, and should 

have, been presented in Complaint Counsel’s affirmative case. 

That strategy violated the meaning of Rule 3.31A, as well as principles of due process 

and fairness. The Rules prohibited Complaint Counsel from calling any expert witness to testify 

at the hearing that it failed to list on its expert witness list. Parties to an FTC administrative 

action are required to “serve each other with a list of experts they intend to call as witnesses at 

the hearing not later than 1 day after the close of fact discovery, meaning the close of discovery 

except for depositions and other discovery permitted under §3.24(a)(4), and discovery for 

purposes of authenticity and admissibility of exhibits.” 16 C.F.R. § 3.31A(a). Therefore, any 

expert not designated in the expert witness list is not permitted to testify at the evidentiary 

hearing, and cannot be later designated a rebuttal expert. See In the Matter of POM Wonderful, 

2011 WL 1429882, at n. 1 (F.T.C. Apr. 5, 2011) (Chappell, A.L.J.) (“an expert must first be 

designated and provide an expert report in order to be allowed to testify”) (emphasis added, 

citing Rule 3.31A(b)); 16 C.F.R. § 3.31A(b) (‘No party may call an expert witness at the hearing 

unless he or she has been listed ...’”). 

Application of the rules in a way that permits surprise rebuttal witnesses (who have not 

previously been identified) is erroneous and leads to fundamental fairness issues for at least two 

reasons. First, Respondent is not entitled to file surreply reports as a matter of course, and

Respondent’s expert testimony is limited at the hearing to what experts wrote in their original 

expert reports. Accordingly, the prospect of a “new” witness leaves Respondent incapable of 

addressing the material raised by that new witness prospectively. Second, even assuming that 

Respondent’s experts could testify beyond the four corners of their original report to address 
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material raised by a surprise rebuttal witness, that concept is inconsistent with judicial efficiency 

and logic because Complaint Counsel is not required actually present the testimony of their 

rebuttal experts. Respondents may therefore be addressing information that will never be 

presented into evidence. In fact, Dr. Michel’s testimony was not fair rebuttal, because it was not 

limited to “that which is precisely directed to rebutting new matter or new theories presented by 

the defendant’s case-in-chief.” Bowman v. Gen. Motros Co., 427 F.Supp. 234, 240 (E.D. Pa. 

1977) (emphasis added). Literally all of Dr. Michel’s testimony covered areas of scientific 

dispute that Complaint Counsel knew of before expert witness lists were due months before trial, 

because all of the issues he testified to either bolstered Complaint Counsel’s initial expert 

testimony, or addressed factual issues (e.g., scientific studies) that should have been part of 

Complaint Counsel’s affirmative case. 

Similarly, ECM was denied an opportunity to present a surrebuttal expert, Dr. Steven 

Grossman, who would have responded to false and scientifically incorrect statements made by 

Dr. McCarthy during his hearing testimony. This case concerned the credibility of expert 

opinion and, yet, ECM was not afforded the same benefits that Complaint Counsel were given 

concerning the presentation of expert testimony. Dr. Grossman’s proffered testimony involved 

an exceptional situation. Dr. Grossman is a colleague of Dr. McCarthy’s. Dr. Grossman is a 

polymer engineer and teaches in the same department as Dr. McCarthy at UMass Lowell. Dr. 

Grossman, if permitted to testify, would have explained that Dr. McCarthy’s scientific positions 

are entirely without merit, in conflict with Dr. McCarthy’s own research, and incompetent with 

respect to basic scientific issues. The relative importance of that crucial testimony renders the 
    PUBLIC DOCUMENT 

220 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

denial of same a considerable violation of rights, as this case may now be determined on an 

incomplete scientific record.254

IV. CONCLUSION

For the foregoing reasons, ECM respectfully requests that this Court deny each of 

Complaint Counsel’s requests for relief, dismiss the Complaint, and enter judgment in ECM’s 

favor. 

 Respectfully submitted, 

/s/ Jonathan W. Emord 

 Jonathan W. Emord 

 Peter A. Arhangelsky 

 Bethany R. Kennedy 

 Eric J. Awerbuch 

 EMORD & ASSOCIATES, P.C. 

 Telephone: 202-466-6937 

 Fax: 202-466-6938 

 Email: jemord@emord.com 

DATED: September 25, 2014 

 

                                                             254 Outright disqualification of an expert is rare and should involve an assessment of the 

public interest in permitting the expert to testify. Koch Refining Co. v. Jennifer L. Boudreau 

M/V, 85 F.3d 1178, 1181-82 (5th Cir. 1996). 
    PUBLIC DOCUMENT 

221 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

CERTIFICATE OF SERVICE 

I hereby certify that on September 25, 2014, I caused a true and correct copy of the 

foregoing to be served as follows: 

One electronic copy to the Office of the Secretary through the e-filing system: 

Donald S. Clark, Secretary 

Federal Trade Commission 

600 Pennsylvania Ave., NW, Room H-113 

Washington, DC 20580 

Email: secretary@ftc.gov 

One electronic courtesy copy to the Office of the Administrative Law Judge: 

The Honorable D. Michael Chappell 

Administrative Law Judge 

600 Pennsylvania Ave., NW, Room H-110 

Washington, DC 20580 

One electronic copy to Counsel for Complainant: 

Katherine Johnson 

Division of Enforcement 

Bureau of Consumer Protection 

Federal Trade Commission 

600 Pennsylvania Avenue, NW 

Mail stop M-8102B 

Washington, D.C. 20580 

Email: kjohnson3@ftc.gov 

Arturo Decastro 

Division of Enfoncement 

Bureau of Consumer Protection 

Federal Trade Commission 

600 Pennsylvania Avenue, NW 

Mail stop M-8102B 

Washington, D.C. 20580 

Email: adecastro@ftc.gov 

Jonathan Cohen 

Division of Enforcement 

Bureau of Consumer Protection 

Federal Trade Commission 

600 Pennsylvania Avenue, NW 

Mail stop M-8102B 

Washington, D.C. 20580 

Email: jcohen2@ftc.gov 

I certify that I retain a paper copy of the signed original of the foregoing document that is 

available for review by the parties and adjudicator consistent with the Commission’s Rules. 

 
    PUBLIC DOCUMENT 

222 

In re ECM Biofilms, Dkt. No. 9358 

ECM’s Post-Trial Brief 

 

 Respectfully submitted, 

 

 Jonathan W. Emord (jemord@emord.com) 

 EMORD & ASSOCIATES, P.C. 

 11808 Wolf Run Lane 

 Clifton, VA 20124 

 Telephone: 202-466-6937 

Facsimile: 202-466-6938 

DATED: September 25, 2014 
RESPONDENT’S WEBSITE APPENDIX

Exhibit Document Description Where Cited

1 "Biodegradable." Merriam-Webster.com. Merriam-Webster, n.d. 

Web. 22 July 2014, available at http://www.merriamwebster.com/dictionary/biodegradable

Post-Trial Brief, p. 

62

2 “Biodegradable.” Collins English Dictionary, 10th Ed. 2009 (July 

22, 2014), available at 

http://dictionary.reference.com/browse/biodegradation

Post-Trial Brief, p. 

62

3 Frequently Asked Questions, The University of Arizona Cancer 

Center, m azcc.arizona.edu (“[m]any standard treatments used today 

are the result of past clinical trials, which involve a strict and 

rigorous, multi-step process that takes eight years on average to 

complete.”), at http://azcc.arizona.edu/patients/clinical-trials/faq (last 

visited Sep. 25, 2014)

Post-Trial Brief, p. 

113

4 “FTC Cracks Down on Misleading and Unsubstantiated 

Environmental Marketing Claims.”FTC.gov, (October 29, 2013). 

Web. 25 September 2014, available at http://www.ftc.gov/newsevents/press-releases/2013/10/ftc-cracks-down-misleadingunsubstantiated-environmental

Post-Trial Brief, p. 

215

5 Aguirre, “Plastics Engineering Educator Praised for Research, Service” 

(Sep. 21, 2012), available at http://www.uml.edu/News/stories/2011-

12/University-Professor-reception.aspx

RPPF ¶ 1407

6 “FTC’s winning streak is over.” The Hill (February 11, 2014), available at 

https://thehill.com/blogs/congress-blog/economy-budget/197969-ftcswinning-streak-is-over

Post-trial Brief, p. 

73
EXHIBIT 1
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biodegradable

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bio·de·grad·able adjective \-di-ˈgrā-də-bəl\

: capable of being slowly destroyed and broken down into 

very small parts by natural processes, bacteria, etc.

Full Definition of BIODEGRADABLE

: capable of being broken down especially into innocuous 

products by the action of living things (as microorganisms) 

<biodegradable trash bags>

— bio·de·grad·abil·i·ty noun

— biodegradablenoun

— bio·deg·ra·da·tion noun

— bio·de·grade verb

See biodegradable defined for English-language learners »

See biodegradable defined for kids »

First Known Use of BIODEGRADABLE

1961

Other Biochemistry Terms

bile, capsaicin, keratin, metabolism

Rhymes with BIODEGRADABLE

photodegradable

bio·de·grad·able adjective \-di-ˈgrād-əbəl\ (Medical Dictionary)

Medical Definition of BIODEGRADABLE 

: capable of being broken down especially into innocuous 

products by the action of living things (as 

microorganisms) 

—bio·de·grad·abil·i·ty noun, 

pluralbio·de·grad·abil·i·ties

—bio·deg·ra·da·tion noun

—bio·de·grade verb, bio·de·grad·edbio·de·grad·ing

Learn More About BIODEGRADABLE 

Spanish Central Translation: "biodegradable" in Spanish

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YuGenn Garcia · Jose Rizal Memorial State University

lisuda 

Reply · Like · July 19 at 9:21pm

Bilal Safdar · Works at NoT yeT woRkiNg !! iM stiLl stUdYinG !!

hehe, im still youth

sometime we use the term biodegrat]dable nano partical what 

are they actually ??

Reply · Like · May 6 at 11:46am

Gwen Craig · Top Commenter

If something "biodegradable" is put into a landfill, such as a 

plastic bag, does it biodegrade? Doesn't it require exposure to 

the elements, in addition to microorganisms?

Reply · Like · · 1 January 16 at 7:32pm

Nwosu Blessing Livinus Jr. · Africa methodist episcopal zion 

university

i really appreciate the work 

Reply · Like · December 13, 2013 at 5:14am

AAliyah MsLady Eaves

Need a sentence 

Reply · Like · October 14, 2013 at 6:11pm

Like 202k

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EXHIBIT 2
(http://blog.dictionary.com/could-care-less/)

Dictionary.com Unabridged

Based on the Random House Dictionary, © Random House, Inc. 2014.

Cite This Source (http://dictionary.reference.com/cite.html?qh=biodegradation&ia=luna)

bi-o-de-grade

[bahy-oh-di-greyd] 

Word Origin 

1.

verb (used without object), biodegraded, biodegrading.

to decay and become absorbed by the environment:

"toys that will biodegrade when they're discarded."

1970-75; back formation from biodegradable

(http://dictionary.reference.com/browse/biodegradable)

biodegradation [bahy-oh-deg-ruh-dey-shuh n] (Show IPA), noun

(http://static.sfdict.com/staticrep/dictaudio/B03/B0345100.mp3)

Origin

1970-1975

Related forms

(http://static.sfdict.com/staticrep/dictaudio/B03/B0345200.mp3)

bi-o-de-grade in Medicine 

How IT Professionals Can Stay Relevant in a Mobile 

by Kaplan University

Thesaurus (http://www.thesaurus.com/browse/biodegradation)

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Cite This Source (http://dictionary.reference.com/cite.html?qh=biodegradation&ia=ahsmd)

biodegradation bi·o·deg·ra·da·tion (bī'ō-děg'rə-dā'shən)

n.

See biotransformation (/search?q=biotransformation). 

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EXHIBIT 3
Patient Care Research Academics

Home Health Plan Spanish Directory Contact Us UA

Patient Care

Make an Appointment

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For New Patients

Multidisciplinary Clinics & 

Treatment

Supportive Care for Healing

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Screening and Prevention

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Questions

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Quick Links

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Locations

UACC Blog 

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En Español

Info by Disease

The University of Arizona Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center, is one of 

the leading sites in the country for the treatment of cancer. In addition to receiving state-of-the-art, evidence-based 

multidisciplinary cancer care, our patients have access to novel targeted therapy medications and innovative treatments 

through clinical trials.

Clinical trials are scientific studies in which people volunteer to participate under the supervision of physicians and research 

professionals. In the realm of cancer, therapeutic clinical trials examine new medications, new combinations of drugs or 

new approaches to surgery or radiation therapy. However, clinical trials may also study new diagnostic and screening 

methods as well as prevention and quality of life strategies.

In therapeutic trials, new treatments, which on average have at least six years of research behind them, are tried in a small 

number of patients in order to determine safety and effectiveness before they can be made widely available. Many standard 

treatments used today are the result of past clinical trials, which involve a strict and rigorous, multi-step process that takes 

eight years on average to complete. Clinical trials are monitored by the National Institutes of Health and the U.S. Food and 

Drug Administration as well as by local oversight boards that ensure volunteers’ rights are preserved.

Inclusion and exclusion criteria, such as age, disease type, medical history and current medical condition, are used to 

identify appropriate participants for a clinical trial and help researchers ensure they can answer the questions they plan to 

study. Before patients decide to enroll in a trial, they learn about a study's treatments and tests, and possible benefits and 

risks, but participants can also withdraw from a study at any time.

Choosing to participate in a clinical trial is an important personal decision. Patients interested in clinical trials should read 

these frequently asked questions and talk to their physician. For more information about clinical trials at the University of 

Arizona Cancer Center, please call (866) 278-1554.

How does a clinical trial work?

A volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational 

treatment or drug while other volunteers may receive a standard treatment, sometimes a placebo, an inactive product, is 

used with a standard treatment to assess the effectiveness of the experimental treatment. The group in which a volunteer is 

placed may not be known to those involved in the study, which allows researchers to objectively observe and evaluate the 

volunteers. Regardless of which treatment volunteers receive, the level of medical attention and care received is the same.

What are the different types of clinical trials?

• Treatment trials – test experimental treatments, new combinations of drugs or new approaches to surgery or 

radiation therapy.

• Prevention trials – look for better ways using medicines, vaccines, vitamins, minerals or lifestyle changes to 

prevent a disease from occurring or returning.

• Diagnostic trials – look for better tests or procedures for diagnosing a disease or condition.

• Screening trials – look for better methods to detect diseases or health conditions.

• Quality of Life trials (or Supportive Care trials) – look for ways to improve comfort and the quality of life for 

individuals with chronic illnesses.

What are clinical trial phases? 

Each phase of the clinical trial process has a different purpose and is treated as a separate study. After completion of a 

phase, investigators must submit data for approval from the FDA before continuing to the next phase.

• Phase I - researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to 

evaluate its safety, determine a safe dosage range and identify side effects.

• Phase II - the experimental drug or treatment is given to a larger group of people (100-300) to see if it is effective 

and to further evaluate its safety.

• Phase III - the experimental drug or treatment is given to large groups of people (1,000-3,000) to confirm its 

effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow 

it to be used safely.

• Phase IV – studies occur after an approved drug is on the market to delineate additional information including the 

drug's risks, benefits and optimal use.

Frequently Asked Questions

About the Center Patient Care Community Outreach Research Academic Programs News & Media Giving Appointments

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Who can participate in a clinical trial? 

Eligible participants are determined by a clinical trial’s inclusion and exclusion criteria, which are based on factors such as

age, disease type, medical history and current medical condition. Some studies seek volunteers with a particular illness to 

be studied, while other trials recruit healthy volunteers. The criteria are used to identify appropriate participants and help 

researchers ensure they can answer the questions they plan to study.

What protections exist for clinical trial participants? 

An Institutional Review Board comprised of scientists and non-scientists of varied backgrounds, genders and ethnicities 

review all human subject research conducted at the Arizona Cancer Center to ensure that studies are ethical and 

participants are not likely to be harmed. The IRB can stop a study if it appears to be causing unexpected harm to 

participants or if it is clear that the new treatment is effective and should be made more widely available.

What is informed consent? 

Doctors and nurses involved in a trial explain the details of a study to interested candidates using terms the potential 

participants will understand. Candidates receive an informed consent document that includes a detailed description of 

what's expected of a volunteer as well as details such as the trial’s purpose, duration, required procedures, risks, potential 

benefits and key contacts. Candidates then decide whether to sign the document and agree to participate in the trial. A 

participant can withdraw from a study at any time without penalty.

What questions should be asked before choosing to participate?

• How long will the trial last?

• Where is the trial being conducted?

• What treatments will be used and how?

• What is the main purpose of the trial?

• How will patient safety be monitored?

• Are there any risks involved?

• What are the possible benefits?

• What are the alternative treatments besides the one being tested in the trial?

• Who is sponsoring the trial?

• Do I have to pay for any part of the trial?

• What happens if I am harmed by the trial?

• Can I opt to remain on this treatment, even after termination of the trial?

What are the possible benefits of joining a trial?

• Access to promising new interventions that are generally not yet available to the public and may be more effective 

than standard therapy.

• Receive highly specialized and monitored medical care and attention.

• Help others by contributing to medical research.

What are the possible risks of joining a trial?

• Experimental treatment may not be more effective than standard treatment or may have unexpected side effects.

• May require more trips to the study site or more treatments.

What happens after the trial?

The data collected from the study is used to determine the therapy’s effectiveness, safety and side effects. Researchers 

then determine whether to move on to the next phase of study. After Phase III of a study is complete, data may be 

submitted to the FDA for approval. If a drug is approved, pharmaceutical companies may continue to conduct studies that 

compare the new drug to other drugs already on the market or assess a drug's long-term effectiveness and impact on the 

quality of a person's life.

How can I find out more? 

Choosing to participate in a clinical trial is an important personal decision. Patients interested in clinical trials should talk to 

their physician. Search a list of open therapeutic trials at the University of Arizona Cancer Center. A searchable registry of 

clinical trials around the world is available at www.clinicaltrials.gov.

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Please contact us with any questions or problems

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Frequently Asked Questions | University of Arizona Cancer Center Page 3 of 3

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EXHIBIT 4
MAIN MENU SEARCH

FTC Cracks Down on Misleading and Unsubstantiated 

Environmental Marketing Claims

Actions Challenge Deceptive Biodegradable Plastics Claims for the First Time 

FOR RELEASE

October 29, 2013

TAGS: restrictions on advertising Retail Merchandise & Clothing Bureau of Consumer Protection

Consumer Protection Advertising and Marketing Environmental Marketing

The Federal Trade Commission today announced six enforcement actions, including one that imposes a 

$450,000 civil penalty and five that for the first time address biodegradable plastic claims, as part of the 

agency’s ongoing crackdown on false and misleading environmental claims.

The plastic cases include a complaint against a company that markets an additive it claims makes plastic 

products biodegradable and four complaints and proposed consent orders against companies that marketed 

various plastics with allegedly false and unsupported claims that their products were biodegradable. In the 

civil penalty case, the FTC filed a complaint and consent order against a company for violating a 1994 FTC 

order that prohibited it from making unsupported green claims for its paper plates and bags.

All of these cases are part of the FTC’s program to ensure compliance with the agency’s recently revised 

Green Guides. The Commission publishes the Guides to help businesses market their products accurately, 

providing guidance as to what constitutes deceptive and non-deceptive environmental claims.

“It’s no secret that consumers want products that are environmentally friendly, and that companies are trying to 

meet that need,” said Jessica Rich, Director of the Federal Trade Commission’s Bureau of Consumer 

Protection. “But companies that don’t have evidence to support the environmental claims they make about 

their products erode consumer confidence and undermine those companies that are playing by the rules.”

Each of the FTC’s plastics matters and, where appropriate, the proposed consent order, and the paper 

products civil penalty settlement are detailed below.

ECM Biofilms, Inc. is based in Ohio and markets its additives (which allegedly make plastic products 

biodegradable) under the trade name MasterBatch Pellets. It advertises its additives on its website and 

through marketing materials, such as fliers and brochures that are available to distributors and manufacturers 

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that incorporate ECM additives into their products. According to the complaint, ECM also issues its own 

“Certificates of Biodegradability of Plastic Products,” which ECM allegedly uses to convince its customers and 

end-use consumers that its additive makes plastic products biodegradable. 

ECM allegedly claimed, for example, that “plastic products made with [its] additives will break down in 

approximately nine months to five years in nearly all landfills or wherever else they may end up.” The 

complaint alleges that these purportedly biodegradable plastics do not in fact biodegrade within a reasonably 

short period of time after disposal in a landfill. Moreover, the complaint alleges that ECM has no 

substantiation to support its claims that its additive makes plastic biodegradable. 

The Commission complaint charges ECM with violating the FTC Act by misrepresenting that: 1) ECM plastics 

(plastics made with ECM additives) are biodegradable and will completely break down within a reasonably 

short period of time after customary disposal; 2) ECM plastics are biodegradable in a landfill; 3) ECM plastics 

are biodegradable in a stated qualified timeframe; and 4) that various scientific tests prove ECM’s 

biodegradability claims. Finally, the complaint charges ECM with providing its customer and independent 

distributors – through the distribution of its promotional materials – with the means to deceive consumers. The 

notice order attached to the complaint would, among other things, prohibit ECM from engaging in each 

violation alleged in the complaint.

The FTC’s complaints against the following companies charge them with misrepresenting that plastics treated 

with additives are biodegradable, biodegradable in a landfill, biodegradable in a certain timeframe, or shown to 

be biodegradable in a landfill or that various scientific tests prove their biodegradability claims. The FTC also 

alleges that the companies lacked reliable scientific tests to back up these claims.

American Plastic Manufacturing is based in Seattle, Washington, and was an ECM customer until at least 

December 2012. The FTC alleges that APM advertised its plastic shopping bags on its website as 

biodegradable, and sold them to distributors nationwide. APM’s marketing materials claimed that its products 

were biodegradable based on the use of the additives sold by ECM.

CHAMP, located in Marlborough, Massachusetts, also was an ECM customer, and advertised on its website 

that its plastic golf tees were biodegradable. CHAMP sold the tees both online and in brick and mortar stores 

throughout the United States. The company’s marketing materials claimed that the ECM additive made its 

products biodegradable.

Clear Choice Housewares, Inc. based in Leominster, Massachusetts, was a customer of an additive 

manufacturer called Bio-Tec Environmental. Clear Choice sold what it claims are biodegradable, reusable 

plastic food storage containers on its website, as well as in retail stores nationwide. Clear Choice’s marketing 

materials claimed its products were biodegradable based on the application of a Bio-Tec product called Eco 

Pure. The FTC alleges that Clear Choice made false and unsubstantiated claims that Eco Pure made its 

products “quickly biodegradable in landfills.”

Carnie Cap, Inc., based in East Moline, Illinois, incorporated Eco-One, an additive manufactured and 

marketed by Ecologic, into its plastic rebar cap covers. Carnie Cap advertised the caps on its website and sold 

them through various distributors nationwide. It claimed, with no qualification, that the Eco-One product 

makes it plastic rebar cap covers “100 % biodegradable.”

The proposed consent orders settling the FTC’s complaints are essentially the same. They prohibit the four 

companies from making biodegradability claims unless the representations are true and supported by 

competent and reliable scientific evidence. Consistent with the Green Guides, the companies must have 

FTC Cracks Down on Misleading and Unsubstantiated Environmental Marketing Claims |... Page 2 of 8

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evidence that the entire plastic product will completely decompose into elements found in nature within one 

year after customary disposal (defined as disposal in a landfill, incinerator, or recycling facility) before making 

any unqualified biodegradable claim. 

For qualified claims, the companies must state the time required for compete biodegradation in a landfill or the 

time to degrade in a disposal environment near where consumers who buy the product live. Alternatively, the 

companies may state the rate and extent of degradation in a landfill or other disposal facility accompanied by 

an additional disclosure that the stated rate and extent do not mean that the product will continue to 

decompose.

The proposed consent orders also make it clear that ASTM D5511 (a test standard commonly used in the 

additive industry) cannot substantiate unqualified biodegradable claims or claims beyond the results and 

parameters of the test, and that any testing protocol used to substantiate degradable claims must simulate the 

conditions found in the stated disposal environment.

AJM Packaging Corporation. AJM manufactures paper 

products, including paper plates, cups, bowls, napkins, 

and bags, for sale throughout the United States. Based in 

Bloomfield Hills, Michigan, the company touts itself as a 

“leading manufacturer of these products,” and refers to its 

lunch bags and Green Label paper plates as national 

brand leaders.

According to the FTC, through its recent marketing 

practices, AJM violated a July 19, 1994, Commission 

consent order that barred it from representing that any 

product or package is degradable, biodegradable, or 

photodegradable unless it had competent and reliable 

scientific evidence to substantiate the claims. The order 

defines the terms “competent and reliable scientific 

evidence,” as well as what constitutes a “product or 

package,” including plates and bags. 

Despite the terms of the order, AJM began making new environmental claims for a number of its papers 

products, including claims that they were “biodegradable,” “compostable” or both. AJM made these claims for 

some of its most popular products, including: Nature’s Own Green Label and Gold Label papers plates, AJM 

lunch bags, AJM grocery bags, and Bio-Save Lawn & Leaf Bags. The packaging for AJM’s paper plates also 

prominently stated that they are “recyclable.”

Based on this conduct, the FTC’s complaint charges AJM with violating the 1994 order by failing to have 

competent and reliable evidence to substantiate claims that: its products will biodegrade within one year when 

disposed in a landfill; its products will compost in a safe and timely manner in a home composting pile; and its 

paper plates are recyclable.

In settling the FTC’s current complaint, AJM agrees to vacate the prior Commission

order and enter into a new order that contains new language and definitions that reflect updates to the Green 

Guides that were finalized last year. Specifically, the updated order bars AJM from making unsubstantiated 

claims that a product or package is biodegradable, compostable, recyclable, or offers an environmental benefit 

and requires AJM to disclose information needed to qualify certain green claims to avoid deception. 

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The court order also requires AJM to pay a $450,000 civil penalty for violating the 1994 order and enjoins AJM 

from violating the new order. The FTC can seek additional penalties if AJM violates the new order in the 

future.

Green Marketing Consumer and Business Education

The FTC recently released several business and consumer education resources designed to help users 

understand its Green Guides and environmental marketing in general. These include: 1) “Environmental 

Claims – Summary of Green Guides,” a four-page summary of the changes in the Guides; 2) “The Green 

Guides,” a video explaining highlights of the changes; 3) a new page on the FTC Business Center, with links 

to legal documents, the Guides and other “green” content; 4) a Business Center blog post; and 5) related 

consumer information.

In addition, the FTC today posted a new blog for consumers to help them understand the issues surrounding 

biodegradable plastics claims in order to make informed purchasing decisions. The post, “Green” Claim 

Check,” can be found on the FTC’s website. The Commission also has new information for businesses, 

“Grading your degradability claims: The latest for green marketers.”

The Commission Votes

The Commission vote to issue the administrative complaint against ECM Biofilms was 4-0. The case will be 

heard before an administrative law judge at the FTC, with the proceeding scheduled to begin on June 18, 

2014.

The Commission vote to accept the consent agreement packages containing the proposed consent orders for 

public comment in each of the four biodegradable plastics cases was 4-0. The FTC will publish a description 

of the consent agreement packages in the Federal Register shortly. The agreements will be subject to public 

comment for 30 days, beginning today and continuing through November 29, 2013, after which the 

Commission will decide whether to make the proposed consent orders final. 

Interested parties can submit written comments electronically or in paper form by following the instructions in 

the “Invitation to Comment” part of the “Supplementary Information” section. Comments in paper form should 

be mailed or delivered to: Federal Trade Commission, Office of the Secretary, Room H-11, and 600 

Pennsylvania Avenue, N.W., Washington, DC 20580. Comments also can be filed electronically:

Comment on the APM matter.

Comment on the CHAMP case.

Comment on the Clear Choice case.

Comment on the Carnie Cap case.

The Commission vote approving the complaint against AJM was 5-0, with former Chairman Jon Leibowitz and 

former Commissioner J. Thomas Rosh participating. The vote to approve the stipulated final order was 4-0. 

 The complaint was referred to the Department of Justice and then back to the FTC. The FTC filed the 

complaint and stipulated order in the U.S. District Court for the District of Columbia on October 1, 2013.

NOTE: The Commission authorizes the filing of a complaint when it has “reason to believe” that the law has 

been or is being violated, and it appears to the Commission that a proceeding is in the public interest.

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NOTE: The Commission refers a complaint to the DOJ for filing when it has “reason to believe” that the law 

has been or is being violated and it appears to the Commission that a proceeding is in the public interest. The 

order has the force of law when approved and signed by the district court judge.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business 

practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or 

Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC 

enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and 

criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a 

variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases

for the latest FTC news and resources.

CONTACT INFORMATION 

MEDIA CONTACT:

Mitchell J. Katz

Office of Public Affairs 

202-326-2161

STAFF CONTACTS:

Megan Bartley

Bureau of Consumer Protection

202-326-3424

(AJM Packaging Corporation)

Katherine Johnson

Bureau of Consumer Protection

202-326-2185

Related Cases

MacNeill Engineering Company, Inc., d/b/a CHAMP, In the Matter of

Carnie Cap, Inc., In the Matter of 

Clear Choice Housewares, Inc., also d/b/a FARBERWARE® EcoFresh, In the Matter of

AJM Packaging Corporation

American Plastic Manufacturing, Inc., In the Matter of 

ECM BioFilms, Inc., also d/b/a Enviroplastics International, In the Matter of

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For Consumers

Blog -“Green” Claim Check

Going Green

For Businesses

Blog - Grading your degradability claims: The latest for green marketers

Environmental Marketing

Video - Green Guides

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Our Media Resources library provides one-stop collections of materials on numerous issues in which the FTC 

has been actively engaged. These pages are especially useful for members of the media.

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EXHIBIT 5
Prof. Stephen McCarthy, 

second from right, is shown 

with, from left, Provost 

Ahmed Abdelal, Chancellor 

Marty Meehan and Prof. 

Robert Parkin.

McCarthy Honored as Newest University 

Professor

Home > News > University Professor reception

Plastics Engineering Educator Praised for Research, Service

09/21/2012

By Edwin L. Aguirre

Chancellor Marty Meehan joined University administrators, 

faculty and staff as well as friends and family members in 

honoring plastics engineering Prof. Stephen McCarthy, who 

was named this year’s University Professor, during a 

reception held at the UMass Lowell Inn & Conference Center 

on Sept. 20. 

Meehan lauded McCarthy for his “exemplary teaching, 

outstanding research and extraordinary service to UMass 

Lowell for nearly three decades.”

“It’s a great honor to receive this award,” said McCarthy. 

“I’m very grateful to Chancellor Meehan, Provost Ahmed 

Abdelal, Dean John Ting and Prof. Bob Parkin, who 

nominated me for this prestigious title. I also want to thank my family for their support and 

understanding, especially for putting up with the long hours I spend working in the 

University.”

A resident of Tyngsboro, McCarthy joined the UMass Lowell faculty in 1984. Among his many 

accomplishments as an innovative educator, he has graduated 25 doctoral students in 

plastics engineering and biomedical engineering as well as several times this number of 

master’s students.

As a world-class researcher, he has obtained nearly $9 million in externally sponsored 

research grants and contracts, plus nearly $33 million in intellectual property donations to 

UMass Lowell. He also founded the Massachusetts Medical Device Development Center

(M2D2), a signature program for the campus. To date, he has published more than 100 peer

-reviewed papers and holds eight U.S. and two international patents. He is also instrumental 

in establishing global partnerships with institutions in Ireland, Northern Ireland, Israel and 

Egypt.

McCarthy’s three-year term will run from September 2012 through August 2015. Previous 

University Professors include Susan Braunhut (biology), 2008–11; Ken Geiser (work 

environment), 2009–12; Robert Giles (physics), 2010–13; and Regina Panasuk (education), 

2011–14.

McCarthy will deliver an annual University Professor lecture next spring about his work on 

biodegradable plastics and medical devices.

To see photos from the reception, visit UMass Lowell’s Photo Gallery.

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University Relations - Cumnock Hall, 31 University Ave., Lowell, MA 01854

Phone: 978-934-3224 Fax: 978-934-3033 Contact Us

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EXHIBIT 6
The Hill 1625 K Street, NW Suite 900 Washington DC 20006 | 202-628-8500 tel | 202-628-8503 fax

The contents of this site are ©2014 Capitol Hill Publishing Corp., a subsidiary of News Communications, Inc.

February 11, 2014, 04:00 pm

FTC’s winning streak is over

Six months ago in Can the FTC be a fair umpire? I wrote in the The Hill's Congress blog about the concerns arising from the Federal 

Trade Commission’s dual role as prosecutor and final decision maker in its administrative litigation. I noted that for 19 years in every case 

brought by the Commission it had found an antitrust violation. I observed “One must wonder about fairness when the pitcher is also the 

umpire - - and is always calling strikes.” This winning streak did not mean a perfect record – indeed in the cases appealed to Courts of 

Appeal the FTC was reversed 20 percent of the time (compared to a 5 percent reversal rate for federal court judges). 

Congress noticed. In two antitrust oversight hearings last fall the FTC was questioned about their “perfect” record. As the Chairman of the 

House Judiciary antitrust subcommittee Spencer Bachus (R-Ala.) said “With this kind of record and an unbeaten streak that Perry Mason 

would envy, a company might wonder whether it is worth putting up a defense at all in a system in which the FTC brings a complaint, the 

case is tried before an administrative law judge at the FTC, and the FTC holds the authority to overturn a decision adverse to the agency.”

Last week, that winning streak ended. In a case involving McWane, a firm that manufactures ductile iron pipe fittings, the Commission 

dismissed all of the complaint counts alleging collusion and all but one of the counts alleging monopolization. (The Commission

deadlocked 2-2 on party lines on two conspiracy counts). 

The Commission did find that exclusive dealing by McWane violated the antitrust laws. On that count, the Commission divided 3-1, with a 

blistering exhaustive 52-page dissent by Commissioner Joshua Wright.

What is the significance of the Commission’s decision?

First, this is an example of good government and common sense. The FTC’s generation long winning streak was indefensible and 

undermined the credibility of the Commission. Courts were increasingly skeptical of the FTC’s administrative process. This decision 

begins to restore a sense of procedural fairness and substantive rationality.

Second, the dissent is the main course. The most compelling jurisprudence is in Commissioner Wright’s dissent. He marshaled the case 

law, economic theory, antitrust policy and a copious recitation of the facts to demonstrate there was no illegal monopolization. His dissent 

demonstrates that the basics of any antitrust case – higher prices, less output or choice, or greater barriers to entry are simply missing. 

Indeed, the most probative evidence – the successful entry of a rival – suggested there was no harm to the market.

Third, don’t bet on the FTC on appeal. As mentioned earlier, when the FTC finds a violation they are often reversed by the appellate 

courts (at a much higher rate than other agencies of district courts). In this case the Commission not only has to overcome the increasing 

skepticism of the courts about fairness in FTC administrative litigation but also Commissioner Wright’s dissent which provides a detailed 

roadmap to reversal. Commissioner Wright’s dissent will be even more compelling because he was one of the leading authorities on the 

new learning on exclusive dealing before he went to the Commission. 

Fourth, reforms matter. Probably no one noticed when in the last month of the Bush II Administration the FTC implemented procedural 

reforms to streamline administrative litigation under the leadership of former Chairman Bill Kovacic. One of the reforms was to require the 

Commission to issue decisions in 180 days after the ALJ initial decision. But for the time limit the Democratic Commissioners could have 

delayed the decision in this case until the fifth Commissioner (a Democrat) took office and they had a majority on the collusion counts. 

That might have been expedient but it would have been poor public policy and further diminished the credibility of the agency.

Finally, Congress matters. The FTC turns 100 years old this year. When its creation was proposed Louis Brandeis, one of the authors of 

the Federal Trade Commission Act said "sunlight is said to be the best of disinfectants." In this case Congressional sunlight on the FTC 

administrative process helped set the Commission on a more prudent course. That’s a valuable lesson for everyone.

Balto is an antitrust attorney and former policy director at the Federal Trade Commission.

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FTC v. Braswell, Not Reported in F.Supp.2d (2005)

2006-1 Trade Cases P 75,267

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2005 WL 4227194

United States District Court,

C.D. California.

FEDERAL TRADE COMMISSION, Plaintiff,

v.

A. Glenn BRASWELL, et al., Defendants.

No. CV 03-3700 DT (PJWX). | Sept. 27, 2005.

Attorneys and Law Firms

Alysa S. Bernstein, Christine Jean Lee, David P. Frankel, David K. Koehler, James A. Trilling, Lawrence DemilleWagman, Mamie Kresses, Marilyn E. Kerst, Richard L. Cleland, Rosemary Rosso, Theodore H. Hoppock,

William E. Kovacic, Federal Trade Comission, Washington, DC, Kenneth H. Abbe, Federal Trade Commission,

Los Angeles, CA, for Plaintiff.

Andrew B. Lustigman, Sheldon S. Lustigman, Lustigman Law Offices, New York, NY, Casey Cooper, Michael

L. Calhoon, Baker Botts, Washington, DC, D. Jay Ritt, Kerry R. Bensinger, Bensinger Ritt & Botterud, Pasadena,

CA, Bryan D. Daly, Charles L. Kreindler, Edward E. Alon, Beck De Corso Daly Kreindler & Harris, G. Cresswell

Templeton, III, Hill Farrer & Burrill, Eugenie L. Warner, Michael L. Mallow, Kirkpatrick and Lockhart, Peter

Morris, Altman and Morris, Los Angeles, CA, for Defendants.

ORDER DENYING DEFENDANT CHASE REVEL'S MOTION FOR

SUMMARY JUDGMENT OR PARTIAL SUMMARY JUDGMENT

TEVRIZIAN, J.

I. BACKGROUND

A. Factual Summary

*1 Plaintiff, the Federal Trade Commission (“FTC” or “Commission”), is an independent agency of the

United States Government created by statute. 15 U.S.C. §§ 41-58. It brings this action against Defendants

A. Glenn Braswell (“Braswell”), JOL Management Co. (“JOL”), G.B. Data Systems, Inc. (“G.B.Data”), Gero

Vita International, Inc. (“Gero Vita”), Theraceuticals, Inc. (“Theraceuticals”), Halsey Holdings LLC (“Halsey”),

Health Quest Publications, Inc. (“Health Quest”), G.B. Data Systems, Inc. (Canada), Ron Tepper (“Tepper”),

Ronald M. Lawrence, M.D., Ph.D. (“Lawrence”), Hans Kugler, Ph.D. (“Kugler”), Chase Revel a/k/a Marcus

Welbourne, John Wellburn, James Wellburn, Martin Wellner, John Meggenhorn, and John Burke (“Revel”).

The following facts are found to be undisputed: 1

1 The Court sets forth these facts based on its review of Revel's Statement of Uncontroverted Facts and Conclusions of

Law, the FTC's Statement of Genuine Issues and Revel's Reply Statement. While many facts were set forth in Revel's

Separate Statement in support of his Motion for Summary Judgment, the Court sets forth only those undisputed facts

relevant to the analysis set forth herein. Other disputed facts are discussed within the analysis portion or were not

relevant based on the Court's determinations of the issues presented in this Motion.

On or about May 27, 2003, the FTC filed its original complaint against Defendants for violations of Sections 5 and

12 of the Federal Trade Commission Act (“FTC Act”). On or about March 30, 2004, the FTC sought leave to add
FTC v. Braswell, Not Reported in F.Supp.2d (2005)

2006-1 Trade Cases P 75,267

 © 2014 Thomson Reuters. No claim to original U.S. Government Works. 2

Revel as a defendant. On or about July 26, 2004, the FTC filed its Second Corrected First Amended Complaint

for Permanent Injunction and Other Equitable Relief (“FAC”).

The FTC alleges that Braswell, Tepper, JOL, G.B. Data, Canada, Gero Vita, Theraceuticals, Health Quest, and

Halsey are part of the “Braswell Common Enterprise.” The FTC does not allege that Revel is part of the Braswell

Common Enterprise. It alleges that the Braswell Common Enterprise “advertised, labeled, offered for sale, sold,

and distributed a variety of dietary supplements and other health-related products to the public, and that its total

sales exceeded $798 million.” Among the products that Defendants are alleged to have advertised, labeled, offered

for sale, sold and distributed in recent years are: Lung Support Formula, Gero Vita G.H.3, and Testerex, all

marketed since at least 1998; ChitoPlex, marketed since at least 1999; AntiBetic Pancreas Tonic, marketed since at

least 2000; and Theraceuticals G.H.3 Romanian Youth Formula, marketed since at least 2001. The FTC has settled

with all of the entities comprising the Braswell Common Enterprise with the exception of Braswell individually.

Revel drafted advertising copy for the Gero Vita companies pursuant to the contract between his company,

Campaign Media Corporation (“CMC”) 2 and Vita Industries (“Contract”). CMC agreed to create advertising

material for direct mail or space advertising to promote Gero Vita's products. Under this Contract, CMC was to

receive royalty payments based on a percentage of the sales generated by the advertising material created by CMC.

Revel ceased working for the Gero Vita companies in early 2001.

2 CMC later became Admax, Inc.

The FAC alleges three counts against Revel for the advertising he wrote for Lung Support Formula, AntiBetic

Pancreas Tonic and Gero Vita GH3. Revel does not dispute that he wrote advertising for these products. The FAC

alleges that Revel made claims that Gero Vita products will “cure, treat, or alleviate” certain conditions; and that

they have been “scientifically tested and proven to be effective;” and that these representations violation Sections

5(a) and 12 of the FTC Act.

*2 More specifically, with respect to the three product claims at issue here, the FTC alleges the following in

its FAC:

(1) Revel “represented, expressly or by implication, that Lung Support: a. Cures or significantly alleviates lung

diseases and respiratory problems, including asthma, colds, influenza, bronchitis, chest congestion, emphysema,

smoking damage, and shortness of breath; b. Reverses existing lung damage in persons with emphysema and

significantly improves their breathing; c. Prevents breathing problems for many persons who do not have existing

respiratory problems; and d. Is clinically proven to eliminate or cure allergies, asthma, colds, influenza, bronchitis,

sinus problems, chest congestions, emphysema, smoking damage, and shortness of breath.”

(2) Revel “represented, expressly or by implication, that AntiBetic: a. Can cure Type I and Type II diabetes; b. is

an effective or superior alternative to insulin or other diabetes medications for the treatment of Type I and Type

II diabetes; and c. is clinically proven to regenerate or repair the pancreatic cells that produce insulin and to lower

blood sugar levels in persons with diabetes.”

(3) Revel “represented, expressly or by implication, that: a. GH3 reverses and prevents age-related memory loss,

dementia, and Alzheimer's disease; b. Persons who use GH3 or Theraceuticals GH3 can live 29% longer; and c.

GH3 is clinically proven to prevent and reverse age-related memory loss, dementia and Alzheimer's disease.”

The FTC alleges that the above-stated representations regarding Lung Support, Antibetic and the GH3 Products

(“Representations”) were made “expressly or by implication” and that they were “false or were not substantiated

at the time [they] were made.” The FTC contends that the “overall net impression” of Revel's advertisements

convey such Representations.
FTC v. Braswell, Not Reported in F.Supp.2d (2005)

2006-1 Trade Cases P 75,267

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B. Procedural Summary

The procedural history in this case is lengthy, as the original Complaint was filed on May 27, 2003, and it has

been set out in previous orders of this Court. This Court hereby incorporates by reference the Procedural Histories

set forth in prior Orders of this Court.

Currently before this Court is Defendant Chase Revel's Motion for Summary Judgment or Partial Summary

Judgment, filed on August 29, 2005.

II. DISCUSSION

A. Standard

Under the Federal Rules of Civil Procedure, summary judgment is proper only where “the pleadings, depositions,

answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine

issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P.

56(c). The moving party has the burden of demonstrating the absence of a genuine issue of fact for trial. See

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 256, 106 S.Ct. 2505, 2514, 91 L.Ed.2d 202 (1986). If the moving

party satisfies the burden, the party opposing the motion must set forth specific facts showing that there remains

a genuine issue for trial. See id.; Fed.R.Civ.P. 56(e).

*3 A non-moving party who bears the burden of proof at trial to an element essential to its case must make a

showing sufficient to establish a genuine dispute of fact with respect to the existence of that element of the case

or be subject to summary judgment. See Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91

L.Ed.2d 265 (1986). Such an issue of fact is a genuine issue if it reasonably can be resolved in favor of either

party. See Anderson, 477 U.S. at 250-51, 106 S.Ct. at 2511. The non-movant's burden to demonstrate a genuine

issue of material fact increases when the factual context renders her claim implausible. See Matsushita Electric

Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 1356, 89 L.Ed.2d 538 (1986). Thus,

mere disagreement or the bald assertion that a genuine issue of material fact exists no longer precludes the use of

summary judgment. See Harper v. Wallingford, 877 F.2d 728 (9th Cir.1989); California Architectural Building

Prods., Inc. v. Franciscan Ceramics, Inc., 818 F.2d 1466, 1468 (9th Cir.1987).

If the moving party seeks summary judgment on a claim or defense on which it bears the burden of proof at trial,

it must satisfy its burden by showing affirmative, admissible evidence.

Unauthenticated documents cannot be considered on a motion for summary judgment. See Hal Roach Studios v.

Richard Feiner and Co., 896 F.2d 1542, 1550 (9th Cir.1990).

On a motion for summary judgment, admissible declarations or affidavits must be based on personal knowledge,

must set forth facts that would be admissible evidence at trial, and must show that the declarant or affiant is

competent to testify as to the facts at issue. See Fed.R.Civ.P. 56(e). Declarations on “information and belief” are

inappropriate to demonstrate a genuine issue of fact. See Taylor v. List, 880 F.2d 1040, 1045 (9th Cir.1989).

B. Analysis

Revel seeks judgment or partial judgment as a matter of law on the following bases:

(1) The FTC cannot meet its burden of proving that any advertisements drafted by Revel contained statements

that were expressly false or deceptive or created a net impression that was false or deceptive;
FTC v. Braswell, Not Reported in F.Supp.2d (2005)

2006-1 Trade Cases P 75,267

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(2) The FTC cannot meet its burden of proving that Revel lacked a reasonable basis for all statements made in

advertising copy drafted by him regarding the products at issue in this case;

(3) The FTC cannot meet its burden of demonstrating the proper calculation of any restitution award against Revel

regarding Lung Support Formula;

(4) The FTC cannot meet its burden of demonstrating that Revel should be subject to any injunctive relief;

(5) Revel has demonstrated that he acted in good faith in drafting the advertisements for Lung Support Formula,

GH3 and AntiBetic.

1. Applicable standards for Sections 5 and 12 of the FTC Act

As set forth above, the FTC alleges that the advertisements drafted by Revel with respect to Lung Support Formula,

GH3 and Antibetic contain representations which are false or were not substantiated at the time they were made,

constituting a deceptive practice, and the making of false advertisements in violation of Sections 5(a) and 12 of

the FTC Act, 15 U.S.C. §§ 45(a) and 52.

*4 Section 5 of the FTC Act declares unlawful “unfair methods of competition in or affecting commerce, and

unfair and deceptive acts or practices in or affecting commerce.”

In support of his Motion, Revel argues that the FTC must meet its burden of demonstrating “substantial consumer

injury” as set forth in 15 U.S.C. § 45(n).

3

 However, the FTC responds that such a showing is the liability

standard for “unfair practices,” and it alleges “deceptive”, not “unfair” practices. See Complaint at ¶¶ 36, 38,

40, 44 (“Therefore, the making of the representations ... constitutes a deceptive practice, and the making of false

advertisements, in or affecting commerce, in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a)

and 52.”) This Court agrees with the FTC.

3 Under § 45(n), an act or practice cannot be declared unlawful on the grounds that such act or practice is unfair unless

the act or practice “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by

consumers themselves and not outweighed by countervailing benefits to consumers or to competition.” 15 U.S.C. §

45(n).

“[T]he ‘cardinal factor’ in determining whether an act or practice is deceptive under § 5 is the likely effect the

promoter's handiwork will have on the mind of the ordinary consumer.” Federal Trade Comm'n v. Sterling Drug,

Inc., 317 F.2d 669, 674 (2d Cir.1963). Under Section 5, the FTC must show that the business entity made material

representations likely to mislead ordinary consumers to their detriment. F.T.C. v. Freecom Communications, Inc.,

401 F.3d 1192, 1203 (10 th Cir.2005); see also Southwest Sunsites, Inc. v. Federal Trade Comm'n, 785 F.2d 1431,

1436 (9 th Cir.1986). Proof of consumer reliance or consumer injury is not necessary to establish a Section 5

violation. Freecom, 401 F.3d at 1203. As such, the FTC's burden of proof does not include “substantial consumer

injury.” 4

4

In his Reply, Revel admits that “the Commission is correct that it may establish a technical violation of the FTC

Act without proof of consumer injury.” However, he contends “the consequences of such a showing are virtually

meaningless for the purposes of the FTC's case against Revel.” He argues that because the only monetary relief that

the FTC seeks from Revel is restitution based on injury to consumers, then the FTC still needs to prove “injury to

consumers.” However, as explained hereinbelow, triable issues of fact exist with respect to the issue of restitution.
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Section 12 of the Act makes it unlawful “to disseminate, or cause to be disseminated, any false advertisement

(1) by United States mails, in or having an effect upon commerce, by any means, for the purpose of inducing,

or which is likely to induce, directly or indirectly the purchase of food, drugs, devices, services, or cosmetics; or

(2) by any means, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase in

or having an effect upon commerce, of food, drugs, devices, services, or cosmetics.” 15 U.S.C. § 52(a). A “false

advertisement” is any advertisement that is misleading in a material respect. 15 U.S.C. § 55; see also F.T.C. v.

Pantron I Corp., 33 F.3d 1088, 1099 (9 th Cir.1994)(“Indeed, a ‘false advertisement’ need not be ‘false’; it need

only be ‘misleading in a material respect.’ ”). In determining whether any advertisement is false or misleading,

the Court must take “into account, among other things, not only representations made or suggested by statement,

word, design, device, sound, or any combination thereof, but also the extent to which the advertisement fails to

reveal facts material in the light of such representations.” 15 U.S.C. § 55.

2. Summary judgment is not warranted on the basis of the net impressions of the advertisements

The FTC's allegations against Revel are based on claims derived from the net impressions created by the

challenged advertisements written by Revel for Defendant Braswell and his companies. Based on the FTC's

allegations, then, the question is whether the net impression of the representation is such that the representation

would be likely to mislead reasonable consumers. FTC v. Gill, 71 F.Supp.2d 1030, 1046 (C.D.Cal.1999).

*5 In seeking summary judgment, Revel argues that the FTC cannot meet its burden of proving that any

advertisements drafted by him contained statements that created a net impression that was false or deceptive. He

contends that his drafted advertisements contain appropriate qualifying language, and that the ads clearly describe

the type of studies that are being relied on. In opposition, the FTC argues that there are genuine issues of fact

regarding the falsity of the net impression claims conveyed by Revel's advertisements. This Court agrees with the

FTC. In other words, a reasonable trier of fact could determine that the net impression of the representations in

Revel's advertisements is such that the representations would be likely to mislead reasonable consumers.

At the outset, this Court notes that contrary to Revel's arguments, individual statements need not be false or

misleading to render a net impression false or misleading. See Sterling Drug, 317 F.2d at 675 (“The courts are

no longer content to insist simply upon the ‘most literal truthfulness' for we have increasingly come to recognize

that ‘Advertisements as a whole may be completely misleading although every sentence separately considered is

literally true.’ ” (citations omitted)); FTC v. Arlington Press, Inc., 1999 WL 33562452 *9 (C.D.Cal.1999)(“Even

if literally true, a representation will be found to be deceptive and in violation of Section 5 of the FTCA is its net

impression is likely to mislead consumers.”). As such, this Court views the representations alleged to be made

by the advertisements and determines whether the fact finder could determine that its net impression is likely to

mislead consumers.

a. Lung Support Formula advertisement

The claims that the FTC alleges are made by this advertisement (see Koehler Decl., Exh. 1) are that Lung

Support Formula: (1) cures or significantly alleviates lung diseases and respiratory problems, including asthma,

colds, influenza, bronchitis, chest congestion, emphysema, smoking damage, and shortness of breath; (2) reverses

existing lung damage in persons with emphysema and significantly improves their breathing; (3) prevents

breathing problems for many persons who do not have existing respiratory problems; and (4) is clinically proven

to eliminate or cure asthma, colds, influenza, bronchitis, and emphysema. (FAC at ¶¶ 35-36.)

A review of the ad shows that the fact finder could determine that these claims are conveyed, either expressly

or impliedly. The ad claims on the cover page that “Scientists Find Amazing Remedy for: Asthma, Bronchitis,

Emphysema and Smoking Damage.” The word “remedy” can communicate a “significant alleviation” for those

diseases. The majority of the ad concerns how individual ingredients have been proven to cure or alleviate
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the symptoms of these conditions and others, including colds, flu and shortness of breath. The claims are

reinforced by expert endorsements touting Lung Support as “scientifically proven to rejuvenate the important lung

function” (Weissman) and “proven” to rejuvenate lungs (Kugler).

*6 Regarding the claim that Lung Support reverses existing lung damage in persons with emphysema and

significantly improves their breathing, the ad reports on a study where researchers reported that they “were able

to reverse ... damage to the alveoli of animals ....” and emphasizes that “They actually reversed emphysema!” In

a conclusion, the ad claims: “It is obvious that asthma, bronchitis, and now, even emphysema, are reversible or

avoidable, if you feed the body [Lung Support].”

Regarding the claim that Lung Support prevents breathing problems for many persons who do not have existing

respiratory problems, the ad conveys this message through its discussion of the extreme dangers that air pollutants

pose to the respiratory system, particularly the destruction of fibers in the lungs. According to the ad, the

ingredients in Lung Support deter damage to the lung, thereby implying that Lung Support will prevent the

development of breathing problems.

The ad represents that Lung Support is clinically proven to eliminate or cure asthma, colds, influenza, bronchitis,

emphysema, and smoking damage. In addition to the express representations on the cover page and the expert

endorsements, the ad develops this claim through the discussion of at least nine scientific or clinical tests that

purportedly support the efficacy of the ingredients found in Lung Support.

Thus, this Court concludes that a fact finder could determine that the express statements and the reasonable

inference therefrom, in the context of the advertisement as a whole, convey to reasonable consumers the claims

regarding Lung Support alleged by the FTC.

b. AntiBetic Pancreas Tonic advertisement

The claims that the FTC alleges are made by this advertisement (see Koehler Decl., Exh. 2) are that AntiBetic

Pancreas Tonic: (1) can cure Type I and Type II diabetes; (2) is an effective or superior alternative to insulin

or other diabetes medications for the treatment of Type I and Type II diabetes; and (3) is clinically proven to

regenerate or repair the pancreatic cells that produce insulin and to lower blood sugar levels in persons with

diabetes. (FAC at ¶¶ 37-38.)

A review of the ad shows that the fact finder could determine that these claims are conveyed, either expressly or

impliedly. The substance of the ad is that the various ingredients in AntiBetic have been demonstrated through

purported scientific tests to be effective in the regeneration of pancreatic cells that produce insulin or regulation

of blood sugar levels. Regarding the implication that AntiBetic cures Type I and Type II diabetes, the ad states

“Formula Can Eliminate the Need for Drugs”; “treatment can be discontinued after between about four and twelve

months, for type I and type II diabetes”; “the formula will cure diabetes”; “clinical tests show that we've finally

found the answer” (expert endorsement); and “wipe one of the worst diseases off the list” (expert endorsement).

*7 Regarding the claim that AntiBetic is an effective or superior alternative to insulin or other diabetes

medications for the treatment of Type I and Type II diabetes, the ad asserts that unlike AntiBetic, conventional

treatments are dangerous and do not provide a cure for diabetes. The ad states:

Whether you are type I or type II diabetic, you know the drugs your doctor gives you aren't

curing the disease; they are only trying to keep your system in balance so you can function and

live, {bold subline: you never get better on drugs} Unfortunately, you never get better using

drugs. The longer you have the disease, the worse it gets because it is almost impossible to
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keep your blood sugar perfectly balanced with drugs.... Now, thanks to the wonders of nature

and an ancient but very wise old doctor, you can stop the awful pillaging of your body ...

Regarding the claim that AntiBetic is clinically proven to regenerate or repair the pancreatic cells that produce

insulin and to lower blood sugar levels in persons with diabetes, the ad references at least nine tests or studies

relating to the regeneration or repair of pancreatic cells, the lowering of blood sugar levels, or the alleviation of

the symptoms of diabetes. The express statement is made that “Clinical tests show that a minimum of four months

is required for those with newly acquired adult-onset blood sugar problems and that it could take up to 15 months

before those dependent on drugs can stop the need for injections.”

Thus, this Court concludes that a fact finder could determine that the express statements and the reasonable

inference therefrom, in the context of the advertisement as a whole, convey to reasonable consumers the claims

regarding AntiBetic alleged by the FTC.

c. Gero Vita GH3 advertisement

The claims that the FTC alleges are made by this advertisement (see Koehler Decl., Exh. 3) are that: (1) GH3

reverses and prevents age-related memory loss, dementia, and Alzheimer's disease; (2) Persons who use GH3 can

live 29 longer; and (3) GH3 is clinically proven to prevent and reverse age-related memory loss, dementia and

Alzheimer's disease. (FAC at ¶¶ 39-40.)

A review of the ad shows that the fact finder could determine that these claims are conveyed, either expressly or

impliedly. Revel's ad informs consumers that age-related memory loss, dementia, and Alzheimer's disease are the

result of brown slime or lipofuscin (age spots) on brain neurons, which is caused by an excess of an enzyme called

monoamine oxidase (MAO), among other things. The ad reveals that excessive MAO can be reduced significantly

by paraminobenzoic acid (PABA) and dimethylaminoethanol (DMAE), ingredients contained in Gero Vita GH3.

Regarding the clinically proven claim, the ad states, on page one in bold: “IF YOU HAVE AGE SPOTS ...

Don't Wait Until Your Memory Gets Worse! Clinical Tests Show The Condition Can Be Reversed!” In addition,

throughout the ad there are references to scientific research linking age-related memory loss, dementia and

Alzheimer's disease to excess lipofuscin and MAO levels and implying that the studies prove that PABA and

DMAE reduce MAO levels.

*8 Regarding the claim that “persons who use G.H.3. can live 29% longer,” the front page headlines proclaims

“STOP THE CLOCK! Scientists Say: You Can Live 29% Longer”. A bold subheadline in the text of the

advertisement declares, “Patients Lived 29% Longer!” The text describes the results of a purported “test” of a

procaine product reporting “that the test group lived an average of 29% longer than the normal life expectancy.”

In addition, the ad includes a discussion of a study involving DMAE (an ingredient in Gero Vita G.H.3) where

mice fed DMAE “extended their life spans by 30% to 40%, even though they were very old when given [the]

nutrient.” The ad connects this test on mice to humans by stating that the report's apparent author “concluded that

those results suggest that humans' life spans may also be increased by taking DMAE regularly.”

Thus, this Court concludes that a fact finder could determine that the express statements and the reasonable

inference therefrom, in the context of the advertisement as a whole, convey to reasonable consumers the claims

regarding Gero Vita GH3 alleged by the FTC.
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In light of the above, then, this Court concludes as a matter of law that the FTC has shown the existence of

triable issues of fact. Therefore, summary judgment in favor of Revel is not warranted on the basis that Revel's

advertisements do not create a net impression that was false or deceptive. 5

5

In his Reply, Revel urges this Court to make a determination as to the net impression claims upon this Motion for

Summary Judgment since the Court will be the trier of fact at the bench trial. However, this Court declines to do so.

Instead, the Court believes that the proper way to proceed it to allow the parties to establish a complete record on

this issue at the time of trial and then render findings and conclusions at that time. In addition, Federal Rule of Civil

Procedure 52(c) (Judgement on Partial Findings) provides:

If during a trial without a jury a party has been fully heard on an issue and the court finds against the party on that

issue, the court may enter judgment as a matter of law against that party with respect to a claim or defense that cannot

under the controlling law be maintained or defeated without a favorable finding on that issue, or the court may decline

to render any judgment until the close of all the evidence.

3. Summary judgment is not warranted on the ground that Revel had a reasonable basis for the

advertisements

Revel argues that the FTC cannot prove that Revel lacked a reasonable basis for his advertising copy. In response,

the FTC argues that genuine issues of fact regarding whether Revel had a reasonable basis for his advertising copy

preclude summary judgment. As explained below, this Court agrees with the FTC.

In Section 12 cases involving objective product claims, the FTC can rely on a “reasonable basis” theory. FTC

v. Garvey, 383 F.3d 891, 901 (9 th Cir.2004)(quoting Pantron I, 33 F.3d at 1096). Under the reasonable basis

theory, the FTC must show that the advertiser lacked a reasonable basis for asserting that the message was true.

Id. (quoting Pantron I, 33 F.3d at 1096). “In determining whether an advertiser has satisfied the reasonable basis

requirement, the Commission or court must first determine what level of substantiation the advertiser is required

to have for his advertising claims. Then, the adjudicator must determine whether the advertiser possessed that

level of substantiation.” Pantron I, 33 F.3d at 1096.

With respect to determining the level of substantiation required, at issue are objective product claims. Objective

product claims contain affirmative information about a product's attributes, performance or efficacy and require

some level of substantiation in support. In re Removatron, 111 F.T.C. 206 (1988). In other words, objective

product claims imply support by a reasonable basis. In the Matter of Thompson Medical Co., 104 F.T.C. 648,

813 (1984), aff'd, 791 F.2d 189 (D.C.Cir.1986), cert. denied, 479 U.S. 1086, 107 S.Ct. 1289, 94 L.Ed.2d 146

(1987). If the ad contains express representations regarding the particular level of support that the advertiser has

for the claim or implies a particular level of substantiation to reasonable consumers, then the reasonable basis

consists of the amount and type of substantiation the advertiser claimed to have. Id. Typically, advertising that

expressly or impliedly represents support by a scientific level of substantiation contains such words as “tested,”

“established,” “here's proof” or “medically proven.” Removatron, 111 F.T.C. 206. If such advertisement represents

that a particular claim has been scientifically established, then the advertiser must possess a level of proof sufficient

to satisfy the relevant scientific community of the claim's truth. Thompson, 104 F.T.C. at 821-22 n. 59.

*9 In this case, this Court concludes that the Revel ads expressly or impliedly represent support by a scientific

level of substantiation. For example:

The GH3 advertisement contains the following statements: “Clinical Tests Show ...”; “Scientists have found ...”;

“American Scientists Confirm ...”; “Considerable clinical evidence is showing ...”; in addition, as detailed above

in subsection 2(c), the ad discusses scientific research and tests. (Koehler Decl., Exh. 3.)
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The AntiBetic ad contains the following statements: “World-Renowned Clinic Involved in Tests”; “clinical tests

have shown ...”; in addition, as detailed above in subsection 2(c), the ad references expert endorsements and tests.

(Id. at Exh. 2.)

The Lung Support ad contains the following statements: “Scientists Find Amazing New Remedy”; “scientists

have recently found ...”; “clinical tests reveal”; in addition, as detailed above in subsection 2(c), the ad discusses

expert endorsements as wells as scientific and clinical tests. (Id. at Exh. 1.) As such, these are claims that the

representations are supported by scientific evidence. The question presented is, then, is what level of scientific

substantiation is needed.

In seeking summary judgment, Revel first asserts that he should not be considered a “full service ‘advertising

agency’ ”, and that instead, he should be considered akin to a commercial “spokesperson”, relying on F.T.C. v.

Garvey, 383 F.3d 891 (9 th Cir.2004), and therefore be subject to the substantiation requirement in that capacity.

This Court concludes that Garvey is inapplicable. In Garvey, Steve Garvey, retired first baseman for the L.A.

Dodgers, was hired by Enforma Natural Products, Inc., creator of a weight loss system, to promote its system

through infomercials and radio and television appearances. The FTC filed a complaint against Garvey alleging

that in marketing the Enforma System, Garvey violated Sections 5(a) and 12 of the FTCA. After a bench trial,

the district court entered judgment in favor of Garvey concluding that Garvey could not be held liable under a

“participant” theory of liability or as an “endorser.” Id. at 896. Importantly, in making its determination, the Ninth

Circuit noted:

The Garvey defendants note that there is no settled standard for the level of inquiry to which

a commercial spokesperson is held when he or she is hired to participate in a television

advertisement. In the context of the knowledge requirement, we find that the fact that the

individual is merely a spokesperson is relevant.

Id. at 902-903 n. 12. Here, Revel cannot seriously contend that he was “merely a spokesperson.”

Indeed, Revel does not dispute that he was responsible for conceiving and drafting advertisements for Lung

Support Formula, AntiBetic Pancreas Tonic and Gero Vita GH3. The FTC offers examples of instances where

Revel exercised control over things such as specific font types, font sizes, and the ages of models in the

photographs. (See Koehler Decl., Exhs. 14-16.) Revel's correspondence and the written “guidelines for handling

[his] work” demonstrate the control he asserted over the advertising he drafted: “There will be NO changes or

additions to my copy other than the normal proofing and editing.... A copy of the typeset piece must be faxed or

[sent] to me for my approval before being sent to the printer.” (Id. at Exh. 15; see also id. at Exh. 16.) According to

Revel: “[F]rom the onset, in fact, ... I wrote all of the advertisements that would go out to acquire new customers”

from 1990 to 1998. (Id. at Exh. 33 at 132-133.) As such, Revel is not comparable to Steve Garvey in Garvey

who was hired merely as a celebrity spokesperson. To the contrary, Revel's actions and duties reflect his role as

an advertiser.

*10 Revel asserts next that even if Revel/Admax is considered to be an advertising agency, he was entitled to rely

on the studies provided by the client to satisfy the reasonable basis requirement. In response, the FTC contends that

the reasonable basis standard for the claims at issue here consist of double-blind, placebo-controlled, randomized

clinical studies. This Court concludes that the FTC has set forth sufficient evidence to establish a genuine issue

for trial as to the applicable standard.

In support of its claim regarding the need for double-blind, placebo-controlled, randomized clinical studies, the

FTC relies on its expert witnesses who each have opined that the adequate substantiation required by qualified

experts in the relevant fields for the efficacy claims at issue in the Complaint for Lung Support Formula, AntiBetic
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Pancreas Tonic and GH3 would include at least one double-blind, placebo-controlled, randomized clinical study.

(Koehler Decl., Exh. 6 at 13-16; 7 at 7-13; 8 at 13-16.) The Court can look to what experts in the relevant area

of study would consider to be adequate in determining the amount of and type of evidence that is sufficient. See

Thompson Medical, 104 F.T.C. at 821. The FTC also points to other courts which have found or upheld that doubleblind, placebo controlled studies are required to provide adequate substantiation for various efficacy claims,

including claims for dietary supplements. See, e.g., Pantron I, 33 F.3d at 1097-98 (placebo control required for hair

growth product); FTC v. SlimAmerica, Inc., 77 D. Supp.2d 1263, 1274 (S.D.Fla.1999)(“Scientific validation of

the defendants' product claims requires a double blind study of the combination of ingredients used in [the product

formula].”); FTC v. Sabal, 32 F.Supp.2d 1004, 1008-09 (N.D.Ill.1998)(rejecting study as valid substantiation, in

part, because it was not blinded or placebo controlled); FTC v. California Pacific Research, Inc., 1991 U.S. Dist.

LEXIS 12967 at *12-13 (D.Nev. Aug. 27, 1991) (only placebo-controlled, double-blind clinical studies meet “the

most basic and fundamental requirements for scientific validity and reliability”).

Finally, the FTC points out that Revel himself acknowledges the importance of a double-blind, placebo controlled,

randomized clinical study. In the opening paragraphs of a 1999 book he co-authored, he acknowledges the

importance of double-blind, placebo controlled testing because “[u]nfortunately, most [stories about the benefits

of nutritional supplements] are written by vitamin companies or herbalists who are touting their own products,

often stretching the truth.” He states:

Today we live in a scientific world where technology has reached a point that we can test the

use of a medicine or nutritional supplement and carefully evaluate its effects in an unbiased

way. The accepted method of evaluating a substance by scientists worldwide is called a

‘double blind’ study. A scientist must eliminate the possibility of bias and the placebo effect.

*11 (Hans Kugler and Chase Revel, Amazing Medicines the Drug Companies Don't Want You to Discover at vii

(1999), excerpts attached as Exh. 25 to Koehler Decl.) Similarly, at his deposition, when Revel testified regarding

his “concept of an appropriate clinical study” that he “would want to rely on in making a claim,” he addressed the

importance of “choosing the participants randomly,” as well as “a double blind situation ... and placebo controlled,

of course.” (Koehler Decl., Exh. 33 at 126-128.)

Revel cites to Federal Trade v. Enforma Natural Products, 362 F.3d 1204 (9 th Cir.2004), for the proposition

that “the Ninth Circuit has not adopted such a rigid standard [double blind, placebo controlled clinical tests] when

adjudicating whether an individual or entity had a reasonable basis for making a claim.” This Court does not

disagree. In Enforma, the defendant appealed the district court's issuance of a preliminary injunction against it,

restricting the sale and marketing of its diet supplement products. Id. at 1208. The Ninth Circuit, however, was

unable to make any determinations because of the insufficiency of the district court's findings of fact. Id. at 1215.

It acknowledged that “[t]here are genuine disputes about the scientific requirements underlying [the defendant's]

substantiation claims.” Id. at 1217. It therefore remanded to the district court for “factual findings sufficient to

determine the basis on which the district court rejected [the defendant's] studies.” Id. Thus, the only guidance that

Enforma offers is that the scientific requirements underlying substantiation claims depend on the facts of the case

and the evidence presented. 6

6

Revel also cites Litton Indus., Inc. v. FTC, 676 F.2d 364 (9 th Cir.1982). However, Litton addresses findings

concerning comparison advertising of “independent microwave oven service technicians” ' preferences and not the

efficacy of health claims. Further, the Ninth Circuit noted that “[t]he order covered only microwave ovens.” Id. at 368.

Thus, in sum, Revel seeks summary judgment on the basis that the FTC cannot establish that he lacked a

reasonable basis for the advertisements. However, by offering unrefuted evidence that the standard should be

double-blind, placebo-controlled tests, the FTC has offered sufficient evidence to withstand summary judgment.
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Further, because the legal determination of the level of substantiation required will be determined by the Court

based upon the evidence at trial, this Court cannot presently address whether Revel has met the standard. The

Court, as the trier of fact, will determine that issue at the time of trial once the standard is determined. Revel is

therefore not entitled to summary judgment on the ground that the FTC cannot prove that he lacked a reasonable

basis.

4. Summary judgment is not warranted on the issue of restitution

Revel argues that the FTC cannot meet its burden of demonstrating any proper restitution award against Revel

regarding Lung Support Formula. This Court construes this argument as Revel seeking partial summary judgment

on the issue of restitution. 7

7 This argument is insufficient for Revel to seek summary judgment as to Count I because the FTC seeks not only

restitution but also a finding of liability, injunctive relief, the costs of bringing this action and any other discretionary

equitable relief. (See FAC at 44-45.)

In support of his argument, Revel asserts that the FTC's reliance on the database from former defendant JOL is

insufficient to provide a reasonable calculation of a restitution award against him. Revel relies on testimony from

JOL's director of information who testified that for the period of time before 2000, there are no back-up tapes

of the data; one can search the accounts payable system only back to 2000; he (JOL's director of information)

cannot testify whether the information in the database is true, complete and accurate; and there were corruption

problems with the database during the period of 1998-2000. Revel also asserts that there are no available financial

documents that show that Admax received any payments for Lung Support Formula.

*12 In response, the FTC contends that it is undisputed that the Gero Vita Companies had total sales of

$35,786,574.73 for Lung Support Formula during the relevant period from 1998 through 2001; Revel was paid a

royalty of 5% on every sale made (less refunds) of Lung Support Formula attributable to the advertisements he

drafted; and Revel was paid approximately $5 million for advertising copy he wrote for the Gero Vita Companies

during the relevant period from 1998 through 2001. The FTC also points out that Revel has not provided any

financial information in response to the FTC's discovery requests, and that the FTC's motion to compel production

of this financial information is currently pending before Magistrate Judge Walsh.

Based on the foregoing, this Court concludes that summary adjudication on the issue of restitution is not warranted.

Triable issues of fact exist regarding, at a minimum, the existence of records and the adequacy of those records.

5. Summary judgment is not warranted on the issue of injunctive relief

Finally, Revel seeks summary judgment on the basis that the FTC cannot meet its burden of proof to show that

Revel should be subject to any injunctive relief. More specifically, he argues that he acted in good faith, and

therefore there is no basis to subject him to a permanent injunction.

As the FTC cites, good faith is not a defense to relief sought under Section 13(b) for violation of Section 5 of the

FTC Act. See Federal Trade Commission v. World Travel Vacation Brokers, 861 F.2d 1020, 1029 (7 th Cir.1988)

(“An advertiser's good faith does not immunize it from responsibility for its misrepresentations.”); Beneficial

Corp. v. Federal Trade Commission, 542 F.2d 611, 617 (3d Cir.1976). Instead, good faith may be offered as an

affirmative defense to the granting of a permanent injunction. See FTC v. Medicor, LLC, 2001 WL 765628, ----2-3

(C.D.Cal.2001); FTC v. Hang-Ups Art Enterprises, Inc., 1995 WL 914179, *3 (C.D.Cal.1995).

As such, in asserting the affirmative defense of “good faith,” Revel bears the burden of proving said defense.

Here, this Court concludes that Revel has not established he is entitled to such a determination as a matter of law.
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The granting of a permanent injunction requires that “there exist some cognizable danger of recurrent violation.”

See Hang-Ups, 1995 WL 914179 at *3 (citing United States v. W.T. Grant Co., 345 U.S. 629, 633, 73 S.Ct.

894, 97 L.Ed. 1303 (1953)). The determination of whether the alleged violations are likely to recur requires the

Court to look at: (1) the deliberateness ... of the present violation, and (2) the violator's past record.” Id. (citing

Sears, Roebuck & Co. v. FTC, 676 F.2d 385, 392 (9 th Cir.1982)). The FTC provides evidence that Revel was

aware of, and knew or should have known, the appropriate standard for making the kinds of claims at issue in the

Complaint. More specifically, Revel had prior experience with the FTC through a Stipulated Final Judgment and

Order signed by him in FTC v. LaserVision, Inc., 94-CV-1961 WJT (C.D.Cal. March 23, 1994). Among other

things, this Order put Revel on notice that it was a violation to “misrepresent[ ], in any manner, directly or by

implication, the existence, contents, validity, results, conclusions or interpretations of any test or study.” (Koehler

Decl., Exh. 12 at 8.) Thus, Revel is not entitled to summary adjudication with respect to injunctive relief.

III. CONCLUSION

*13 Accordingly, this Court DENIES Defendant Chase Revel's Motion for Summary Judgment or Partial

Summary Judgment.

IT IS SO ORDERED.

Parallel Citations

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In re Trans Union Corp. Privacy Litigation, Not Reported in F.Supp.2d (2009)

 © 2014 Thomson Reuters. No claim to original U.S. Government Works. 1

2009 WL 4799954

Only the Westlaw citation is currently available.

United States District Court,

N.D. Illinois,

Eastern Division.

In re TRANS UNION CORP. PRIVACY LITIGATION.

This Document Relates to: All Case.

No. 00 C 4729. | MDL Docket No. 1350. | Dec. 9, 2009.

MEMORANDUM OPINION AND ORDER

ROBERT W. GETTLEMAN, District Judge.

*1 The remaining issues in this multi-district litigation arise from an overabundance of greed by two sets of

lawyers recognized by the court as among the attorneys representing the plaintiff class. After many years of

litigation and hammering out a successful global settlement, 1 this court and Magistrate Judge Michael Mason

encouraged plaintiffs' attorneys to agree on the amount of fees that would be sought, and Magistrate Judge Mason

attempted to mediate an agreement among the various groups of lawyers as to amount and allocation. That

attempt failed because Texas counsel 2 demanded $2.85 million in fees, which was greater than the (undisclosed)

allocation agreed by the remaining attorneys, who sought a total fee award of $15.1 million.

1 The settlement created a $75 million cash fund (the “Fund”) to be distributed to a nationwide class pursuant to a

complex formula (see Order entered September 17, 2008, Doc. No. 515) and capped attorneys' fees at 25% of the

Fund ($18.5 million) subject to approval by the court. The settlement also included substantial in-kind relief.

2 Michael A. Caddell, Cynthia B. Chapman and Corey Fein of Caddell & Chapman, and Mitchell A. Toups of Weller,

Green, Toups & Terrell, L.L.P.

By order dated April 6, 2009 (the “April 6 Order”), this court decided to award a total of $10.83 million in

fees. In re Trans Union Corp. Privacy Lit., 2009 WL 937158. When that order was vigorously contested by

Texas and Louisiana counsel, 3 by order dated June 11, 2009 (Doc. No. 635) the court vacated the award and

appointed Edward W. Feldman as Special Master pursuant to Fed.R.Civ.P. 53 to: (a) examine the time records

of all counsel; (b) recommend a fee award; (c) investigate any ethical issues, including those related to Louisiana

counsel identified in the April 6 Order; and (d) perform additional inquires related to the duties specified above.

3 Dawn Adams Wheelahan, and Steven J Lane, Stephen I. Herman and Soren E. Gisleson of Herman, Herman, Katz

& Cotlar, L.L.P.

On October 1, 2009, the Special Master submitted (but did not file in the public record) a 76 page Report and

Recommendation (the “R & R”), which the court finds to be remarkable not only for its content, but for its

style, thoroughness and overall excellence. Consequently, because the court approves and adopts the R & R in its

entirety, the court attaches and incorporates the R & R to this opinion.

The R & R recommends a total fee award of $12,980,000, representing 17.3% of the Fund, allocated as follows:

$7,836,683 to MDL and Frey counsel (hereafter, together, “MDL counsel”); 4 $2,722,360 to Louisiana counsel;

$1,815,319 to Texas counsel; $550,000 to liaison counsel; 5 and $55,638 to the Special Master. The award to

liaison counsel was agreed by all parties and has been distributed, as have approved out-of-pocket expenses. The
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award to the Special Master represents1⁄2 of his fees and expenses, and was so ordered by this court's June 11,

2009, order. The other half is to be paid from the proceeds remaining to be distributed to the class.

4

Joy Ann Bull and Eric J. Niehaus of Coughlin, Stoia, Geller, Rudman & Robbins, L.L.P.; Jon W. Borderud of Law

Offices of Jon W. Borderud; Matthew Righetti of Righetti Law Firm and John N. Zarian of Zarian, Midgley & Johnson

PLLC.

5 Terry Rose Saunders and Thomas A. Doyle of Saunders & Doyle.

The only parties to object to the R & R were, not surprisingly, Louisiana and Texas counsel. In addition to seeking

even more fees, Louisiana counsel seeks to suppress the Special Master's discussion of the ethical issues that this

court directed him to investigate. For the reasons discussed below, the objections to the R & R are overruled,

Louisiana counsel's request to suppress the portions of the R & R dealing with attorney Dawn Wheelahan's ethical

lapses is denied, and MDL counsel are directed to distribute the money remaining in the Fund to the attorneys

pursuant to the allocation recommended by the Special Master, with the remaining funds to be distributed to the

plaintiff class as specified in the order approving the settlement agreement.

Louisiana and Texas Counsels' Objections to the R & R

*2 Louisiana counsel's principal objection to the R & R can be summed up simply: they (principally attorney

Dawn Wheelahan) believe that they should be credited with most if not all of the difference between the original

and final settlement agreements, and awarded a generous percentage of that difference (and 75% of the fees

associated with that difference). Texas counsel's objection to the R & R is limited to the Special Master's conclusion

that MDL counsel should be awarded 50% of the difference. These arguments ignore many factors that distinguish

this case from the cases these lawyers—particularly Ms. Wheelahan—rely on. 6 These factors are unique to the

instant litigation and are well known to this court through its extensive involvement in the contested proceedings

as well as the settlement negotiations. These include:

6 These cases include In re Synthroid Marketing Litigation, 264 F.3d 712 (7th Cir.2001), and In re Synthroid Marketing

Litigation, 325 F.3d 974 (7th Cir.2003), and their progeny.

(a) Trans Union's liability in the instant case, at least for its target marketing activities, was never in doubt,

as this court noted in its April 6 Order. The 2001 opinion by the United States Court of Appeals for the

District of Columbia confirmed Trans Union's liability for violating the FCRA. See, Trans Union Corp. v.

FTC, 245 F.3d 809, (D.C.Cir.2001). The principal challenges facing plaintiffs' counsel were how to structure

the class(es) and achieve a recovery that would be collectible without forcing Trans Union (which had a net

worth of approximately $1 billion) into bankruptcy.

(b) Louisiana and Texas counsels' entry into the MDL litigation was relatively late, 7 after many of the

issues had been litigated and narrowed through the efforts of MDL counsel.

7 The instant litigation began in 1999, and was approved as an MDL in 2000. Louisiana counsel filed the Andrews

action (03 C 4331) in 2003, and successfully sought to remand it to state court in Louisiana. It was not until December

2004 that Louisiana counsel filed the Morse action (05 C 831) in the U.S. District Court for the Eastern District of

Louisiana, which that counsel unsuccessfully sought to remove from the MDL. Louisiana counsel later brought in

Texas counsel, who had filed their case (Jowers, 06 C 3074) in the Eastern District of Texas in April 2006.

(c) The increase in the Fund resulted as much from the tireless, patient efforts by Magistrate Judge Mason as

from the efforts of any of plaintiffs' counsel. 8 Magistrate Judge Mason, with the concurrence of this court,

made it quite clear that the original settlement offers were inadequate, and that Trans Union would have
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to put substantially more money on the table if the court were to seriously consider a proposed class-wide

settlement. As detailed below and in the R & R, the course of these discussions took some rather unusual turns.

8 Unlike Louisiana counsel, MDL counsel is gracious enough in its fee petition briefs to acknowledge this indisputable

fact.

(d) The path that led the parties and the court to the ultimate settlement in this case took some novel, unexpected

twists and turns that belie Louisiana counsel's attempts to denigrate and minimize the contribution of other

attorneys to the settlement ultimately achieved. First, shortly after Pretrial Order No. 1 was entered by Judge

Aspen (who preceded the undersigned judge) in late 2000, at Judge Aspen's urging the parties attempted to

mediate a settlement with Judge Abner J. Mikva (Ret.). Next, in 2002, based on the circuit court precedent

then existing, this court denied a nationwide statutory damages class under the FCRA, dismissed claims

for declaratory and injunctive relief and nominal damages, and dismissed state law claims for invasion of

privacy and misappropriation. 9 These holdings were reaffirmed by the court in connection with the second

amended complaint filed in November 2002. 10 These rulings obviously diminished the settlement value of

the case at that time.

9

In Re Trans Union Privacy Litigation, 211 F.R.D. 328 (N.D.Ill.2002).

10 In Re: Trans Union Privacy Litigation, 326 F.Supp.2d 893 (N.D.Ill.2004).

*3 (e) Despite these setbacks, MDL counsel aggressively pursued this litigation, taking extensive discovery,

resisting a series of motions filed by the defendants, and successfully seeking a certification of a statewide

firm offer class. In re Trans Union, 2005 WL 2007157. These efforts, among others pursued by MDL counsel,

kept this litigation alive throughout the years that led to the March 2008 hearing in which this court informed

the parties that, in light of recent changes in precedent and other matters, it might reconsider the denial of

a nationwide class (even if that meant putting Trans Union out of business), and encouraged the parties to

reconsider their settlement positions. 11 As detailed in the R & R and in MDL counsels' briefs, this event

was a major factor that led the parties to the ultimate settlement. 12

11 Indeed, as the Special Master has noted, at a January 15, 2009, hearing the court discussed the change in precedent

and the possibility of revisiting certification of a nationwide class.

12 For these reasons, Texas counsel's narrow objection to the R & R's conclusion that MDL counsel should receive 50%

of the enhancement of the Fund is overruled.

(f) Louisiana counsel's initial efforts in the MDL were aimed at displacing the MDL counsel who had been

appointed by Judge Aspen in Pretrial Order No. 1. Failing that, Ms. Wheelahan then devoted most of her

energy trying to extricate her Louisiana case (Morse ) from the MDL. A great deal of time and judicial

resources were wasted in these activities.

(g) As described in the court's April 6 Order and in detail by the Special Master in his R & R,

Ms. Wheelahan has engaged in unprofessional and marginally unethical behavior. Ms. Wheelahan's

inexcusable padding of her time records would be cause enough to cut her fees substantially or deny

them outright. Brown v. Stackler, 612 F.2d 1057, 1059 (7th Cir.1980). Indeed, the lack of integrity of

those time records was one of the principal reasons that the court appointed a special master to examine

the fee petitions, thus delaying the final resolution of this case and distribution of the Fund to the class,

and causing added expense to the class and other counsel. Ms. Wheelahan's ceaseless and irresponsible

attacks on MDL and Texas counsel, Magistrate Judge Mason, 13 and even the Special Master, 14 and her

needlessly prolonging this litigation would justify sanctions cutting her fees far more than the Special
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Master recommends. See Mirfasihi v. Fleet Mortgage Corp., 551 F.3d 682, 687 (7th Cir.2008), cert.

denied., Perry v. Mirfasihi, ––– U.S. ––––, 129 S.Ct. 2767, 174 L.Ed.2d 271 (2009).

13 It has recently come to the court's attention that, in her submissions to the Special Master, Ms. Wheelahan disparaged

Magistrate Judge Mason's motivations and judicial behavior. As just one example, in an improper October 1, 2009,

ex parte email to the Special Master, Ms. Wheelahan states: “Judge Mason seems to have a chip on his shoulder as

big as the world, where I'm concerned, simply because I opposed two inadequate settlements that he wanted—and

he wanted them because he just didn't know any better, and wouldn't listen in the way that Judge Gettleman, who is

intelligent, did. That is what Mason resents.”

14 In her latest maneuver, Ms. Wheelahan filed a “Motion for a Status Report” in which she erroneously claimed that the

Special Master, through his law firm's representation of an entity related to certain individuals who controlled Trans

Union, was somehow disqualified from acting as Special Master. As this court ruled on November 17, 2009 (Doc.

No. 687), Mr. Feldman's response to this attack clearly established that no such conflict existed.

As previously recognized by this court, Ms. Wheelahan and her colleagues no doubt contributed to the settlement

that was ultimately achieved in this case. They are being rewarded handsomely for their efforts. Their objections to

the Special Master's R & R are unseemly and, frankly, embarrassing to the legal profession that has taken enough

hits in the public perception. Although this court would have been inclined to impose sanctions on Ms. Wheelahan

for her conduct in this case, in light of the thorough and well reasoned discussion by the Special Master, the court

chooses to exercise its discretion to forego such sanctions, approve the report in its entirety, and allow the class

to receive the relief for which its members have waited far too long.

*4 For these reasons, rather than prolong this opinion unnecessarily, the court incorporates the Special Master's

thorough analysis of the arguments advanced by the various sets of lawyers, his analysis of the case law

(particularly the Synthroid cases relied upon by Louisiana counsel) and the history of this litigation, his application

of a percentage basis of recovery, “cross checked” by a “rough” lodestar analysis, and his allocation of fees among

counsel. It would be difficult to improve on the Special Master's report, and the court will not endeavor to do so.

Ethical Issues Related to Attorney Wheelahan

With respect to the ethical issues raised by attorney Dawn Wheelahan's conduct, the court, in the exercise of

its discretion, reluctantly adopts the Special Master's recommendation not to impose sanctions against her. The

R & R thoroughly analyzes the emails Wheelahan sent to her co-counsel in an attempt to threaten them with

a circuitous, ill-advised and likely to fail effort to torpedo the settlement to enhance her own fees. The Special

Master concluded that, although her conduct was reprehensible, unprofessional and “stray[ed] far beyond conduct

becoming of an attorney” (R & R at 61), Wheelahan should not be sanctioned because she took no action to carry

out the threats and likely would not have succeeded to defeat the settlement even if she had done so.

This court remains disturbed (and disappointed) by conduct of a lawyer that would even come close to the line of

betraying the interests of a client (especially a consumer class for which the court has recognized the lawyer as

its representative) in order to augment the lawyer's fees. Even more disturbing is the Special Master's conclusion,

amply supported by the record, that Wheelahan made misrepresentations to him in her attempt to explain the emails

by claiming that the use of the term “motion to dismiss” in the November 19, 2008, email was an “accident,” and

that she did not intend to convey a threat to Texas counsel to undermine the settlement in an effort to convince

them to lower their fee demand (R & R at 46–61). While the court agrees with the Special Master that Wheelahan's

conduct did not rise (or sink) to the level of extortion or sanctionable deception (R & R at 62–69), coupled with

her unseemly attacks on her co-counsel and the integrity of both the Special Master and the Magistrate Judge, as

well as her grossly excessive time sheets, her conduct deserves censure by the court. 15
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15 In her arguments to the Special Master and in her objections to the R & R, Ms. Wheelahan contends that discussion

of her ethical transgressions should be held in confidence pursuant to L.R. 83.25 (governing disciplinary proceedings

before the court's Executive Committee). As pointed out in the R & R, L.R. 83.25 does not include “sanctions or

contempt” proceedings.

CONCLUSION

For the foregoing reasons, the court approves, adopts and incorporates herein the attached Report and

Recommendation of Special Master submitted to the court on October 1, 2009, and orders a total fee award of

$12,980,000 to be allocated as follows: $7,836,683 to MDL counsel; $2,722,360 to Louisiana counsel; $1,815,319

to Texas counsel; $550,000 to liaison counsel; and $55,638 to the Special Master. MDL counsel are directed to

pay these fees forthwith and distribute the balance to the plaintiff class and the Special Master pursuant to the

settlement agreement and the order appointing the Special Master. MDL counsel are further directed to file a

report indicating compliance with this order within 28 days.

ATTACHMENT

REPORT AND RECOMMENDATION OF SPECIAL MASTER

EDWARD W. FELDMAN, Special Master.

*5 Edward W. Feldman

Special Master Pursuant to Order of June 11, 2009

Miller Shakman & Beem, LLP

180 North La Salle Street, Suite 3600

Chicago, IL 60601

(312) 263–3700

TABLE OF CONTENTS

I. INTRODUCTION .......... 1

A. Summary of Order and Assignment .......... ...................1

B. Summary of Steps Taken to Carry out the Assignment .......... ...................1

C. Summary of Recommendations .......... ...................2

1. Total fee recommendation.................................................................................................... 2
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2. Allocation recommendation.................................................................................................. 2

3. Summary of recommendations regarding ethical and billing issues........................................ 3

II. FEE AWARD DETERMINATION .......... 3

A. Litigation Background .......... ...................3

B. Legal Standards for Determining Common Fund Fee Awards .......... ...................6

C. Relevant Market Data .......... ...................8

1. Actual fee agreements.......................................................................................................... 9

2. Awards in other cases.......................................................................................................... 10

3. Class Counsel Auctions........................................................................................................ 12

D. Application .......... .................15

E. Cross–Checks .......... .................21

% F. Allocation .......... .................31

1. The amounts requested by counsel....................................................................................... 31

2. Allocation standards............................................................................................................. 33

3. Allocation analysis............................................................................................................... 34

III. INVESTIGATION OF THE WHEELAHAN NOVEMBER 19 E–MAILS AND OTHER ETHICAL

ISSUES ..........

40

A. Summary of the Issue and Recommendation .......... .................40

B. Ms. Wheelahan's Procedural Objections .......... .................41

C. Description of the Relevant E–Mails .......... .................43
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D. Ms. Wheelahan Did Not Actually Betray or Harm the Settlement Class .......... .................46

1. Ms. Wheelahan's denial is supported by the record and common sense.................................. 47

2. Texas Counsel's theory that Ms. Wheelahan actually tried to undermine the settlement is

implausible and unsupported.................................................................................................

50

E. Ms. Wheelahan's Intent .......... .................55

1. The e-mails were intended as threats.................................................................................... 56

2. Ms. Wheelahan acted alone in making the threat................................................................... 61

3. The threats do not warrant a sanction................................................................................... 61

IV. OTHER ETHICAL ISSUES—BILLING PRACTICES .......... 70

A. Charges for Travel .......... .................70

B. Supreme Court Argument .......... .................73

C. Other Items Flagged by the Court .......... .................74

D. General Review of Billing Records .......... .................75

V. CONCLUSION .......... 75

*6 Special Master Edward W. Feldman, appointed pursuant to the Court's order of June 11, 2009 (Doc. 635,

“June 11 Order”), respectfully submits the following Report and Recommendation.

I. INTRODUCTION

A. Summary of Order and Assignment

In the June 11 Order, the Court provided that my duties were to include (i) examining the time records of all

counsel, (ii) recommending whether to base the fee award on a lodestar or percentage basis, (iii) investigating any

ethical issues raised by Louisiana Counsel's (or any other counsel's) time records and communications discussed

in the court's April 6, 2009 memorandum opinion and order (Doc. 591, “April 6 Order”), and (iv) any other similar

issues that may be raised during the performance of my duties. By Order dated July 30, 2009 (Doc. 637), the

Court clarified that assignment (ii) included making a recommendation as to the total amount of an award and an

allocation of that amount among plaintiffs' counsel.
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B. Summary of Steps Taken to Carry out the Assignment

Throughout the assignment I was assisted by Roger Perlstadt of my firm. (My partner Diane Klotnia also provided

helpful comments on a draft of this Report.) Our work included the following: review of various pertinent

pleadings in the record; conducting phone conferences with counsel; requesting from counsel and then reviewing

documents, such as detailed time and billing records and communications among counsel relevant to the ethical

issues; examining several counsel of record (Ms. Wheelahan and Messrs. Toups, Zarian, Fein, Borderud and

O'Neil); researching applicable law; and drafting this Report. All counsel cooperated fully with my investigation.

Plaintiffs' counsel fall generally into four groups, which are discussed herein: MDL Counsel, Louisiana Counsel,

Texas Counsel and Liaison Counsel. Louisiana Counsel consists of Dawn A. Wheelahan LLC and Herman,

Herman, Katz & Cotlar. Texas Counsel consists of Caddell & Chapman; Weller, Green, Toups & Terrell, LLP,

and Edelman, Combs, Latturner & Goodwin, LLC, their local counsel in Chicago. Liaison Counsel is Saunders &

Doyle. MDL Counsel consists of all other plaintiffs' counsel in this matter, including Zarian Midgley & Johnson,

who may be referred to individually as (“Frey Counsel”). Collectively, Louisiana Counsel, Texas Counsel, Liaison

Counsel and MDL Counsel will be referred to as “Plaintiffs' Counsel.”

C. Summary of Recommendations

1. Total fee recommendation

The Stipulation of Settlement establishes a cap on attorneys' fees of $18.75 million. In the fee petitions previously

filed with the Court, plaintiffs' counsel collectively requested $17.95 million. In its April 6 Order, which the Court

later vacated, the Court applied the percentage-of-fund method and awarded $10.83 million. For reasons explained

below, I recommend that the total attorneys' fee award be determined on the percentage-of-fund method. Having

received detailed time records from counsel, which had not been provided to the Court by most counsel, I also used

a rough lodestar analysis as a cross-check on the reasonableness of the fees determined by the percentage method.

Applying that methodology, I recommend a total attorneys' fee award of $12,980,000. This figure represents

17.3% of the cash settlement fund of $75 million and 11.8% of the total settlement value of $109.6 million.

2. Allocation recommendation

*7 After determining that the total recommended fee would be $12.98 million, I disclosed the figure to plaintiffs'

counsel and gave them a short period to determine whether they could agree on an allocation based on that figure.

They could not do so. They then submitted briefs regarding a proposed allocation. After careful consideration of

their briefs and review of applicable portions of the record, I recommend the following allocation of the $12.98

million award, should the Court adopt it:

• By prior agreement and court order, $550,000 to Liaison Counsel.

• Pursuant to the June 11, 2009 Order, one-half of the Special Master's fees and expenses, $55,638, to the

Special Master.

• For the balance, $12,374,362:

# $7,836,683 to MDL Counsel (including Frey Counsel).

# $2,722,360 to Louisiana Counsel.

# $1,815,319 to Texas Counsel.
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3. Summary of recommendations regarding ethical and billing issues

I investigated each of the ethical issues raised in the Court's April 6, 2009 Order, with primary emphasis on the

November 19, 2008 e-mails attached as Appendix B to that opinion. While those e-mails were wholly inappropriate

and, as the Court put it, “reprehensible,” under the totality of the circumstances I do not recommend that any formal

sanction be imposed on Ms. Wheelahan. Likewise, Ms. Wheelahan's inclusion of travel time in her billing detail,

although unreasonable and based on an untenable reading of Seventh Circuit case law, was not so egregious as to

warrant a sanction. Finally, the other billing issues noted by the Court, while involving excessive or unreasonable

time entries, also do not warrant any sanction. It is disappointing that none of Plaintiffs' Counsel appear to have

exercised any billing judgment to review duplication or inefficiencies and reduce their raw lodestars. However,

I did not find any sanctionable transgression.

II. FEE AWARD DETERMINATION

A. Litigation Background

Because the history of the case is relevant to determining the fee award under the ex ante market-based approach

prescribed by the Seventh Circuit, I give a brief summary. In August 1998, a putative class action was filed by

Frey Counsel in California state court (the “Frey Action”), alleging various violations by Trans Union Corp.

(“Trans Union”) of the Fair Credit Reporting Act (“FCRA”), 15 U.S.C. § 1681 et seq. A similar action against

Trans Union was also filed shortly thereafter in California state court (the “Martinelli Action”). In early 1999, the

Martinelli Action was removed to federal court in California. Other cases making similar allegations were filed by

various MDL Counsel in other federal district courts in 1999 and 2000. In 2000, the Judicial Panel on Multidistrict

Litigation transferred the Martinelli Action and the other federal cases to this district. Ultimately, fourteen cases

were consolidated in this district, including one filed by Louisiana Counsel in federal court in Louisiana in 2005

(the “Morse Action”), and one filed by Texas Counsel in federal court in Texas in 2006 (the “Jowers” Action).

The fourteen consolidated federal cases will be referred to collectively herein as the “MDL Action.” In addition,

Louisiana Counsel filed a similar case in Louisiana state court in December 2002 (the “Andrews Action”).

*8 In 2004, a “target marketing” class was certified in the Andrews Action. In 2005, a “firm offer” class was

certified in the MDL Action. In 2006, MDL Counsel, Liaison Counsel and Trans Union agreed in principle to a

class settlement (the “First Proposed Settlement”), and a motion for preliminary approval of the First Proposed

Settlement was filed in November 2006. The amount of the First Proposed Settlement was $20 million cash, plus

in-kind relief. Louisiana Counsel objected to the motion for preliminary approval, and the motion was ultimately

withdrawn in April 2007.

After further negotiations, a motion for preliminary approval of another proposed settlement (the “Second

Proposed Settlement”) was filed in September 2007. Under the Second Proposed Settlement, Trans Union agreed

to provide to a nationwide class of consumers free online credit monitoring services valued at around $50 per

consumer, and establish a $20 million fund to provide cash payments of $25 each to class members without

internet access. Louisiana Counsel again objected to the motion for preliminary approval, this time joined by

Texas Counsel. In January 2008, Magistrate Judge Mason recommended that the Second Proposed Settlement

not be approved. The Court overruled all objections to the recommendation, and ordered a settlement conference

before the Magistrate Judge.

Further negotiations quickly led to a third proposed settlement in April 2008 (the “Final Settlement”). The Court

granted preliminary approval of the Final Settlement in May 2008 and final approval in September 2008. 16 The

Final Settlement provided $75 million cash, plus “basic” and “enhanced” in-kind relief, the retail value of which

ultimately redeemed by class members totaling just over $34.6 million.
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16 Several objectors filed appeals of the final approval, all of which have now been resolved.

The Final Settlement capped the potential attorneys' fee award at 25% of the cash settlement fund of $75 million,

i.e., $18.75 million. After the Final Settlement was approved, in October and November 2008, Magistrate Judge

Mason attempted to mediate an agreement among Plaintiffs' Counsel as to the total amount of attorneys' fees

that would be sought from the Court, and the allocation of such fees. No agreement was reached, and Plaintiffs'

Counsel moved for a fee award. All Counsel except Texas Counsel jointly requested $15.1 million in fees, to

be allocated pursuant to an undisclosed agreement among them. Texas Counsel requested a total fee award of

$2.85 million. Only Louisiana Counsel submitted hourly detail in support of the request. Other Plaintiffs' Counsel

alleged total hours worked and amounts claimed, breaking the work down in seven broad categories without

supporting billing detail.

On April 6, 2009, the Court entered an order awarding all Plaintiffs' Counsel a total attorneys' fee of $10.83

million. This award was based on the “percentage-of-fund” method notwithstanding the Court's general preference

for the “lodestar” approach. The Court directed Plaintiffs' Counsel to determine whether they could agree on an

allocation of the $10.83 million award. They were unable to agree. In addition, Louisiana Counsel filed a Rule

59(e) motion to amend the fee award. The Court ultimately vacated the April 6 Order. Among the tasks assigned

to me was to recommend whether to use the percentage or lodestar method, and recommend an appropriate award

and allocation based on the chosen method.

B. Legal Standards for Determining Common Fund Fee Awards

*9 In common fund cases such as this, a court has the equitable power to compensate attorneys from the recovery

won for plaintiffs. Harman v. Lyphomed, Inc., 945 F.2d 969, 973 (7th Cir.1991). Because the payment of attorneys'

fees comes from the common fund, after attorneys secure a settlement, their role with respect to fees changes

from one of fiduciary for their clients to that of claimants against the fund created for their clients' benefit. Cook

v. Niedert, 142 F.3d 1004, 1011 (7th Cir.1998). Consequently, “the court becomes the fiduciary for the fund's

beneficiaries and must carefully monitor disbursement to the attorneys by scrutinizing the fee applications.” Id.

Basically, “the district court must ensure that plaintiffs pay no more than what is reasonable.” Id. at 1012. As an

agent of a court, a special master necessarily assumes the same fiduciary function.

Courts in common fund cases have discretion to choose either the lodestar or percentage method of calculating

fees. Florin v. Nationsbank of Ga., N.A., 34 F.3d 560, 566 (7th Cir.1994). The Seventh Circuit has noted

advantages and disadvantages to both approaches. The chief advantage of the percentage approach is simplicity

of administration. See, e.g., Florin, 34 F.3d at 566; In re Continental Ill. Sec. Litig., 962 F.2d 566, 572–73 (7th

Cir.1992). The chief advantage of the lodestar approach is accountability. See, e.g., Harmon, 945 F.2d at 974;

Cook, 142 F.3d at 1013 (citing Harmon ).

Ultimately, in the Seventh Circuit, the market controls. Thus, the Seventh Circuit is less concerned with the choice

between the lodestar or percentage method than with approaching the determination through the lens of the market.

The analysis should be determined from what an arms-length negotiation between the class and the lawyers at the

beginning of the case would have likely produced. In re Synthroid Marketing Litig., 264 F.3d 712, 718–19 (7th

Cir.2001) (“Synthroid I” ) (“Timing is more important than the choice ... between percentage and hourly rates,

for [both] of these systems have their shortcomings.”). Thus, under either approach, the Seventh Circuit requires

that “when deciding on appropriate fee levels in common-fund cases, courts must do their best to award counsel

the market price for legal services, in light of the risk of nonpayment and the normal rate of compensation in the

market at the time.” Id. at 718.

While the Seventh Circuit is agnostic as between the lodestar and percentage methods, this Court expressed a

preference for the former, although it ultimately employed the latter in the April 6 Order because of the inadequacy
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of the time records submitted by Plaintiffs' Counsel. Now that Plaintiffs' Counsel have produced hourly billing

records pursuant to my request, it would now be possible to engage in a thorough and detailed lodestar analysis.

However, I chose to employ the percentage method and recommend that to the Court. I did this for two reasons.

*10 The first is time and expense. As noted above, the percentage method is much less burdensome than the

lodestar method to administer. As a fiduciary to the class, I am particularly sensitive to that factor here. I do not

wish to charge the class what it would cost for me to pore line by line through the billing records of over thirty

law firms recording time in some sixteen lawsuits. In most lodestar cases, the district court judge presiding over

the class action assesses the reasonableness of the hours and an adversary has culled the billings to flag issues.

I have no familiarity with the efforts of Plaintiffs' Counsel in the MDL Action during the litigation and there is

no adversary. And neither I nor the Court is familiar with the work that was done in the separate lawsuits outside

of the proceedings in the MDL Action. Engaging in detailed line-by-line review, including review of activities

in other venues, which would be required to assess reasonableness, would be expensive under any circumstances

and even more so here. These burdens do not outweigh any purported advantage of the lodestar approach over the

percentage approach. Rather, by employing a rougher “lodestar cross-check” below, I have retained most of the

“accountability” of that approach, while preserving the administrative ease of the percentage approach.

A second advantage to the percentage approach in this case is that it is more consistent with the market-mimicking

approach endorsed by the Seventh Circuit. As discussed below, that approach suggests that an ex ante arms-length

negotiation between a hypothetical class representative and a hypothetical single law firm would have resulted

in a contingent, percentage-based fee agreement rather than an hourly fee arrangement. While that fact is not

determinative, see Cook, 142 F.3d at 1013 (“market's preference” for percentage-based fee is only one of several

factors), it does lend additional support to following the percentage approach.

C. Relevant Market Data

In Synthroid, determining a market-based percentage fee was relatively easy. One group of sophisticated plaintiffs

had, at the outset of their relationship, negotiated an arms-length fee agreement. Thus, there was an actual marketbased transaction in the record that, in that case, “define[d] the market.” Synthroid I, 264 F.3d at 720 (emphasis

in original). No such luck here. Instead, I must hypothesize an arms-length negotiation at the outset between

a sophisticated party representing the interests of the class and counsel seeking to represent the class. While

recognizing the mistiness of trying to determining ex post (nearly 10 years later) what an ex ante fee agreement

would have looked like, the Seventh Circuit has suggested three guiding lights: (1) any actual fee agreements

between plaintiffs and their attorneys, (2) data from other common fund cases, and (3) information on classcounsel auctions, in which judges solicit bids from different attorneys seeking the right to represent a class. See

Synthroid I, 264 F.3d at 719; Taubenfeld v. Aon Corp., 415 F.3d 597, 599 (7th Cir.2005). I address each of these

guides in turn.

1. Actual fee agreements

*11 This is the least helpful guide in this case. At my request, Plaintiffs' Counsel provided their contingent fee

agreements with individual plaintiffs in the various actions here, which range from 25% to 45%. Such agreements

shed only a flicker of light here, for two reasons.

First, Synthroid I' s reference to negotiated fee agreements is not well-suited beyond the type of facts in that

case. The fee agreements in Synthroid were negotiated by insurance companies, “sophisticated purchasers of legal

services,” at the outset of their engagement of counsel. Synthroid I, 264 F.3d at 720. See also In re Synthroid

Marketing Litig., 325 F.3d 974, 976 (7th Cir.2003) (“Synthroid II” ) (“All of the [insurance companies] are

sophisticated financial intermediaries with in-house counsel who can (and do) shop for legal services in a national

market.”). As noted above, such agreements, where they exist, can “define the market.” Synthroid I, 264 F.3d at
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720 (emphasis in original). Here, in contrast, the fee agreements were entered into by presumably less sophisticated

individual consumers. See id. (“The [insurance company] contracts provide little guidance on how to compute

fees for the consumer class.”).

Second, the contingent fee agreements here are between the lawyers and individual plaintiffs, not the entire

class. 17 As one district court applying the Seventh Circuit's market-mimicking approach has noted, “the

paramount question remains what the lawyer would hypothetically charge in a class action specifically.” Nilsen

v. York County, 400 F.Supp.2d 266, 279 (D.Me.2005) (emphasis in original). 18 In Synthroid, the insurance

companies were negotiating over their money. The fees were going to come out of any award to the clients

negotiating the agreements. Here, in contrast, no individual plaintiffs were negotiating over the class's money, and

thus, “no member of the class ha[d] a sufficient stake to drive a hard-or any-bargain with the lawyer.” Continental,

962 F.2d at 572. See also In re Comdisco Sec. Litig., 150 F.Supp.2d 943, 949–50 (N.D.Ill.2001) (Shadur, J.).

Thus, in this context, the fee agreements have minimal relevance to determining a proper award. See Nilsen, 400

F.Supp.2d at 279–80. See also Vizcaino v. Microsoft Corp., 290 F.3d 1043, 1049 (9th Cir.2002).

17 Indeed, one of the fee agreements submitted to me expressly declines to establish a fee if a class is certified, noting

that the attorneys will ask the Court to award attorneys' fees if a class is certified.

18 Although obviously not bound by Seventh Circuit precedent, the court in Nilsen “adopt[ed] the methodology of the

Seventh Circuit as most reflective of what a judge does instinctively in setting a fee as well as most amenable to

predictability and an objective external constraint on a judge's otherwise uncabined power.” 400 F.Supp.2d at 278.

2. Awards in other cases

In Synthroid I, the Seventh Circuit's consideration of fees in other common fund cases appeared to be limited to

other cases in which fees had been privately negotiated. 264 F.3d at 720 (“A second benchmark for determining

legal fees is data from securities suits where large investors have chosen to hire counsel up front.”). Thus,

under the market-based approach, the pertinent awards in other common fund cases may be limited to cases in

the securities or similar contexts where there were institutional or sophisticated plaintiffs to negotiate fees up

front. 19 Our research uncovered no FCRA suits in which sophisticated plaintiffs negotiated attorneys' fees up

front. Nevertheless, awards in other class actions generally (even where no fees were negotiated ex ante ) may

provide some marginally useful information about hypothetical market negotiations, because they may influence

the expectations of lawyer and client engaging in the hypothetical negotiation. See Nilsen, 400 F.Supp.2d at 282–

83 (“Other courts' awards necessarily affect the expectations of lawyers and, therefore, what they might agree to

in voluntary negotiation.”).

19 For example, in the Enron securities litigation, a large sophisticated lead plaintiff (the Regents of the University of

California) negotiated an ex ante fee agreement with one of the MDL Counsel law firms (Coughlin Stoia), which

provided an increasing sliding scale of an 8% fee on the first billion dollars, 9% on the second billion, and 10%

on recoveries above $2 billion. The Court ultimately approved a fee award of $688 million, representing 9.52% of

the total recovery. See In re Enron Corp. Securities, Derivative & ERISA Litigation, 586 F.Supp.2d 732, 766–79

(S.D.Tex.2008). The Enron fee agreement is of limited guidance here, since the balance of risks and rewards were

much higher in that case (there was never any realistic prospect of a recovery in the billions here), and the work

and out-of-pocket expenditures required to litigate the matter dwarfed what was required here. See id. at 771 et seq.

(detailing the risks and work).

*12 A body of academic literature analyzes data on attorneys' fees in various class actions. A few recent published

opinions attempt to sift through some of the literature, with varying conclusions. The court in Nilsen found that

“[m]edian attorney fee awards in other class actions generally ... range within a few percentage points on either

side of 30%.” 400 F.Supp.2d at 281. Another court determined that “considerable authority (both statistical and

judicial) exists to support a finding that the prevalent percentage attorney fee awards range from a low of around
In re Trans Union Corp. Privacy Litigation, Not Reported in F.Supp.2d (2009)

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20 percent ... to a high of between 25 to 30 percent....” In re Cabletron Sys. Inc. Sec. Litig., 239 F.R.D. 30, 42

(D.N.H.2006).

20 The court in Cabletron pointed out, however, that one of the studies it cited determined that

awards were typically lower in non-securities common fund cases as compared to securities cases. Id. at 42 (citing

Theodore Eisenberg & Geoffrey P. Miller, Attorney Fees in Class Action Settlements: An Empirical Study, 1

J. Empirical Legal Stud. 27 (Mar.2004)). Indeed, Eisenberg and Miller determined that the mean fee award in

common fund consumer class actions ranges from 16.2% to 24.3%. 1. J. Empirical Legal Stud. at 51, Table 1.

20 Like Nilsen, the court in Cabletron was not bound by Seventh Circuit precedent, but nonetheless adopted its marketmimicking approach. 239 F.R.D. at 40–41.

Eisenberg and Miller further found that “the level of client recovery is by far the most important determinant of

the attorney fee amount [and that a] scaling effect exists, with fees constituting a lower percent of the client's

recovery as the client's recovery increases.” 1 J. Empirical Legal Stud. at 28. As noted above, the client recovery

here was $75 million cash, plus in-kind relief valued at over $34 million. The Eisenberg and Miller study reports

the mean fee award for a recovery of $109 million to be 17.6% to 19.5%, and, looking only at the cash component

here, the mean fee for a recovery of $75 million to be 16.9% to 23.9%. Id. at 73, Table 7. 21 Eisenberg and Miller

propose that an attorneys' fee award within one standard deviation of the mean for any particular recovery level

should be viewed as generally reasonable. Id. at 74. Applying the standard deviations reported by Eisenberg and

Miller suggests a reasonable range of 8.4% to 27.8% of the $109 million total, or 6.7% to 32.9% of just the cash

component. Id. at 73, Table 7. 22

21 Table 7 of the Eisenberg and Miller study reports mean fee award percentages based on two data sets: published federal

and state opinions reporting class action fee determinations, and an article in Class Action Reports that surveyed more

than 600 common fund class actions. The award percentages reported from each data set are broken into deciles by

size of client recovery, which is measured in 2002 dollars. The percentages based on the Class Action Reports data

further breaks out non-securities cases. Thus, the figures noted above were taken from the mean fee award percentages

reported in Table 7 based on the published opinion data and the non-securities Class Action Reports data for client

recoveries in the ninth decile ($79 to $190 million) for the total value of the settlement here, and the eighth decile ($38

to $79 million) for only the cash portion of the settlement. See Turner v. Murphy Oil USA, Inc., 472 F.Supp.2d 830,

864 n. 30 (E.D.La.2007) (“[Looking to Eisenberg and Miller's data sets to determine an average percentage for cases

of similar magnitude] is similar to the ‘market-mimicking approach’ employed by courts within the Seventh Circuit.”).

22 The standard deviation reported for the 17.6% mean fee award on a $109 million recovery in the published opinion

data set is 9.2. The standard deviation reported for 19.5% mean fee award on a $109 million recovery in the Class

Action Reports data set for non-securities cases is 8.3. The standard deviation reported for the 16.9% mean fee award

on a $75 million recovery in the published opinion data set is 10.2. The standard deviation reported for the 23.9% fee

award on a $75 million recovery in the Class Action Reports data set for non-securities cases is 9.0.

3. Class Counsel Auctions

The Seventh Circuit has described class counsel auctions as follows:

[T]he word “auction” is an imprecise description of the process that judges have used

to choose lead counsel in class actions. Judges don't look for the lowest bid; they look

for the best bid-just as any private individual would do in selecting a law firm, an

advertising firm, or a construction company. Bidding law firms provide the judge with firm

profiles, testimonials of former clients, predictions of expected recovery, fee proposals,

and arguments on why their firm provides good value. The judge in turn acts as an agent

for the class, selecting the firm that seems likely to generate the highest recovery net of

attorneys' fees.
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*13 Synthroid I, 264 F.3d at 720 (internal citations omitted). One district court in 2006 reported the winning

bid structures of seven auction cases from various other courts. Cabletron, 239 F.R.D. at 43–44. Although the

court did not attempt to survey every case in which an auction was used, it reported “bidding cases for which

information relating to the fee structure was readily accessible electronically.” Id. at 43 n. 21. The results of that

survey are reprinted below:

In re: Oracle Securities Litigation

No. 3:90–cv–0931–VRW (N.D.Cal.)

Recovery 0–12 Months 13+ Months

First $1M 24% 30%

Next $4M 20% 25%

Next $ 10M 16% 20%

Excess of $15M 12% 15%

In re: Wells Fargo Securities Litigation

No. 3:91–cv–1944–VRW (N.D.Cal.)

Recovery <12 Months >12 Months Trial Forward

First $3M 24% 27% 32%

Next $7M 22% 25% 30%

Excess of $10M 20% 23% 28%

In re: Amino Acid Lysine Antitrust Litigation

No. 1:95–cv–7679 (N.D.Ill.)

Recovery

First $5M 20%

Next $10M 15%

Next $10M 10%

Excess of $25M no additional fee

Wenderhold v. Cylink Corp.

No. 3:98–cv–4292–VRW (N.D.Cal.)

Recovery Pleading–MTD MTD–SJ SJ–Trial Posttrial–Final Appeal
In re Trans Union Corp. Privacy Litigation, Not Reported in F.Supp.2d (2009)

 © 2014 Thomson Reuters. No claim to original U.S. Government Works. 15

$0–$.5M 10% 25% 30% 35%

Next $.5M 10% 17.5% 25% 30%

Next $4M 5% 15% 17.5% 20%

Next $5M 5% 10% 15% 12.5%

Next $5M 5% 7.5% 12.5% 12.5%

Next $5M 5% 5% 10% 10%

Excess of $20M 5% 2.5% 5% 10%

In re: Bank One Shareholders Class Actions

No. 1:00–cv–880 (N.D.Ill.)

Recovery

First $5M 17%

Next $10M 12%

Next $10M 7%

Excess of $25M no additional fee

In re: Comdisco Securities Litigation

No. 1:01–cv–2110 (N.D.Ill.)

Recovery

Any sum recovered 7.5%

In re: Quintas Corp. Securities Litigation

No. 3:00–cv–4263–VRW (N.D.Cal.)

Recovery Pleading–MTD MTD–SJ SJ–Trial Posttrial–Final Appeal

First $4M 7.5% 8.5% 9% 9%

Next $4M 7% 8% 8.5% 8.5%

Next $4M 6.5% 7.5% 8% 8%

Next $4M 6% 7% 7.5% 7.5%

Next $4M 5.5% 6% 6.5% 6.5%

Excess of $20M 5% 5.5% 6% 6%
In re Trans Union Corp. Privacy Litigation, Not Reported in F.Supp.2d (2009)

 © 2014 Thomson Reuters. No claim to original U.S. Government Works. 16

Id. at 43–44. Applying these fee structures to the present settlement would result in fee awards ranging from 4.4%

to 23.3% if only the $75 million cash portion is considered, or from 3.8% to 23.2% of the entire $109.6 million

cash plus in-kind amount. 23

23 As former math and physics majors, respectively, who fled a life of mathematical rigor for the law, Mr. Perlstadt and I

arguably should not be trusted with a calculator. Nevertheless, if we are right, our calculations reveal that application

of the auction case fee structures to the settlement here would result in the following fee awards: Wenderhold: 4.4% of

cash, 3.8% of total; Bank One: 7.0% of cash, 6.4% of total; Amino Acid Lysine: 8.0% of cash, 7.1% of total; Quintas:

6.0% of cash, 5.8% of total; Comdisco: 7.5% of cash, 7.5% of total; Oracle: 16.4% of cash, 16.0% of total; Wells

Fargo: 23.3% of cash, 23.2% of total. In the cases of Bank One and Amino Acid Lysine, we modified the scale slightly.

The winning bids in each case had a self-imposed cap on fees. The Seventh Circuit criticized that result in Synthroid

I, 264 F.3d at 720–21, as eliminating an incentive for class counsel to increase recoveries for the class. Thus, our

calculations assumed a 5% fee recovery at the highest tier in each of those two cases.

It should be kept in mind that, except for Amino Acid Lysine, an antitrust case, these auction cases were all in

securities litigation, which Eisenberg and Miller noted generally result in higher fee awards. (A typical securities

or antitrust case involves more risk than was present in this case; I discuss risk below.) In any event, as with the

ex post fee awards in other cases considered above, the fee structures in the auction cases considered here are, at

best, only illustrative. Each case has unique facts and risk factors. Yet the auction cases do offer insight into what

attorneys may be willing to accept to represent a class before the outcome of litigation is known. These cases belie

common rules of thumb or conventional wisdom, such as a “norm” of a 25% or 33% contingent fee, which underlie

some of the ex post fee awards from other Circuits analyzed in the Eisenberg & Miller study discussed earlier.

D. Application

*14 In trying to apply Synthroid I' s imperative to “do [my] best to award counsel the market price for legal

services, in light of the risk of nonpayment and the normal rate of compensation in the market at the time,”

264 F.3d at 718, I now try to imagine a hypothetical negotiation at the outset of the litigation between a single

sophisticated representative of the potential class and a single-group of lawyers proposing to represent the potential

class. This approach obviously omits much of the complexity present in this litigation, but my goal here is not

the impossibility of replicating exactly an ex ante market transaction, but simply to approximate one as best I

can given the information available. See Synthroid I, 264 F.3d at 719 (noting that it is “impossible” to derive

the ex ante result years later, but consideration of other market transactions is a “starting point”); Nilsen, 400

F.Supp.2d at 279.

First, I believe a negotiation likely would have resulted in a contingent, rather than a pure hourly, fee arrangement,

as were most of the insurer agreements in Synthroid. See Synthroid II, 325 F.3d at 976. The fact that the individual

fee agreements here were contingent lends further support to this conclusion. 24

24 It is not uncommon that a blended arrangement might be negotiated, e.g., a discounted or blended hourly rate combined

with a contingent bonus at a smaller percentage than would pertain to a pure contingency fee situation. However,

such arrangements are negotiated when the client has the funds to pay a reduced hourly rate. That is not the case in

a consumer class action like this case.

Next, I believe that a negotiation likely would have resulted in a downward sliding scale, such that, as in most

of the auction cases noted above, the attorneys' fee award percentage decreases as total class recovery increases.

While some judges in the auction cases told bidding law firms that they preferred a sliding scale, Judge Shadur in

Bank One and Amino Acid Lysine left it within the discretion of bidding counsel to determine how to formulate

their proposals. See Laura L. Hooper & Marie Leary, Auctioning the Role of Class Counsel in Class Action Cases:

A Descriptive Study, 32 (Fed. Judicial Ctr.2001) (reprinted at 209 F.R.D. 519). Whether as a result of judicial

pressure or on counsel's own initiative, the auction cases suggest (consistent with the Eisenberg and Miller study)
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that counsel competing in the market are willing to accept class action representations on a downward sliding

fee basis. A hypothetical sophisticated representative of the class here would likely have demanded it. See also

Synthroid II, 325 F.3d at 975 (“[T]he market rate, as a percentage of recovery, likely falls as the stakes increase.”).

Further, in its own application of the market-mimicking approach in Synthroid II, the Seventh Circuit ultimately

awarded fees to consumer class counsel on a downward sliding scale. 325 F.3d at 980 (awarding class counsel

30% of the first $10 million in class recovery, 25% of the next $10 million, 22% of the next $26 million, and 15%

of all amounts over $46 million up to the $88 million recovery).

Finally, I believe that a hypothetical ex ante negotiation would have resulted in a lower contingent fee percentage

for in-kind relief. Presumably, the class here (indeed, probably most classes) would rather have cash than in-kind

relief. A check for $60 is more valuable to most people than getting free credit monitoring services with a retail

value of that amount. The consumer might prefer to spend the money on groceries or something else. Thus, the

class would want to incentivize counsel to push for more cash relative to in-kind relief. The class also would not

want attorneys' fees on in-kind relief to drain the cash portion of any settlement. And they would want the in-kind

recovery forming the basis for a fee award to be valued at the amount of in-kind benefits actually redeemed, not

those potentially available. Valuing a coupon recovery based on redeemed value is now required for percentage

fee awards under the Class Action Fairness Act (“CAFA”), 28 U.S.C. § 1712(a). While not applicable to this case,

CAFA's objective of tying the attorneys' fee to the actual redeemed recovery is likely a point the negotiator for

the class would have insisted on. Thus, the ex ante agreement would assign a lower percentage to the redeemed

in-kind recovery of the class.

*15 Determining the foregoing criteria (contingent fee, sliding scale, lower fee for in-kind relief) was the

easy part. Now comes the hard part. In an exercise that is clearly more art than science, I must attach actual

numbers to the hypothetical downward sliding contingent fee agreement. To summarize the three types of data

discussed above (with their varying relevance and utility), the actual fee agreements here entered into between

individual plaintiffs and their counsel range from 25% to 45%, fee awards from other (mostly ex post, non-market

based) cases suggest a total fee award here of anywhere from 6.7% to 32.9%, and the auction cases suggest a

total fee award of anywhere from 3.8% to 23.3%. The breadth of these ranges reveals an irony. The Seventh

Circuit criticized the non-market approach of other Circuits as “chopped salad” because they relied on vague

and ultimately arbitrary notions of fairness without the objectivity and discipline of the market. Synthroid I, 264

F.3d at 719. However, as is evident from the above discussion, when trying to imagine a hypothetical market

transaction nearly a decade after the fact, the market data provide only limited and inconsistent guidance. In this

case, the market approach may not produce “chopped salad,” but the variety of data it generated still seems to

yield something akin to a vegetable stir-fry.

Culinary metaphors aside, one additional, important factor advances the analysis and helps narrow the range of

market information: consideration of the ex ante risks and potential rewards of the litigation. See Sutton v. Bernard,

504 F.3d 688, 693 (7th Cir.2007) (market price is determined, in part, by risk of nonpayment and the stakes of

the litigation), citing Synthroid I, 264 F.3d at 721.

25

25 Obviously other factors would affect the final outcome of any negotiation, such as skill of the negotiators on each side,

the relationship between the parties, and the class negotiator's assessment of the attorneys' quality. Such intangibles

are impossible to consider in the absence of actual ex ante negotiations, and their omission here does not undermine

this approach, which, as noted above, is market-mimicking, not market-replicating.

The potential rewards here were substantial. If a nationwide class could be certified, and statutory damages were

available, the potential exposure to Trans Union was in the billions. 26 Facing potentially company-destroying

exposure, a settlement of eight or low-nine figures appears to have been a reasonable ex ante prospect, anywhere

from $20 million at the low end, to $40 or $50 million in the middle, to $75 to $100 million or more at the high end.
In re Trans Union Corp. Privacy Litigation, Not Reported in F.Supp.2d (2009)

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26 The FCRA provides for statutory damages from $100 to $1,000 for willful violation of the act. 15 U.S.C. § 1681n(a)

(1)(A). A nationwide class reportedly could have covered 190 million people.

In contrast, regarding risk, the Court determined in its April 6 Order that the risk to the attorneys in taking on

this litigation was relatively low. By 1994, the FTC had determined that Trans Union was violating the FCRA.

Although that decision was reversed by the D.C. Circuit in 1996, the FTC on remand again held in 2000 that

Trans Union was violating the FCRA, which was ultimately upheld by the D.C. Circuit in 2001. See generally

Trans Union Corp. v. FTC, 245 F.3d 809 (D.C.Cir.2001). Up to this point, I have not specified exactly when

the hypothetical negotiation should be considered to have taken place, other than to describe it as ex ante or “at

the outset.” Recall that the Frey Action and the Martinelli Action were filed in 1998 and 1999. In 1998, the

FTC action appears to have been in the remand stage following the D.C. Circuit's original reversal. Thus, Trans

Union's liability for FCRA violations had not been definitively determined at that time. However, since we are

considering a negotiation concerning a nationwide recovery, I think it is reasonable to assume that the hypothetical

negotiation would have occurred some time during 2001, after the MDL assignment to this Court and coordinated,

nationwide proceedings were commencing. Given the FTC's continued litigation against Trans Union, and the

ultimate affirmance of Trans Union's liability by the D.C. Circuit in 2001, I believe that the negotiating parties

would assess the risk of a ruling that Trans Union did not violate the FCRA as relatively low. See April 6 Order at

9 (“[T]he risk of no recovery was virtually nonexistent due to the FTC action.”). The anticipated costs of discovery

and experts would have been less here than in many large class cases with complicated technical issues, such as

securities, product liability or antitrust cases. As the Court found, id. at 3, the ex ante risks in the actions here would

have revolved around the scope and structure of class certification, and establishing willfulness for purposes of

statutory damages, matters that go to the amount rather than fact of recovery. I am unable to quantify these risks

with precision, but the total ex ante risks to counsel in accepting these representations were relatively low, certainly

lower than most contingent class actions. That conclusion is borne out by the fact that over thirty law firms here

ultimately participated as plaintiffs' counsel. Many law firms plainly perceived a favorable risk/reward ratio here.

*16 In any event, the risks to Plaintiffs' Counsel here appear to be lower than the risks facing the consumer

class counsel in Synthroid. See Synthroid II, 325 F.3d at 978 (“Consumer class counsel ... took the risk that they

would come away with nothing ... [and] that was a significant risk, for the consumer class did not have an easy

road.”). In Synthroid, the district court had divided plaintiffs into two classes, one of consumers, and one of thirdparty payors such as insurers. Synthroid II, 325 F.3d at 976. After noting that the consumer class faced much

more risk than the third-party payor class, the Seventh Circuit held that in order to compensate for risk-bearing,

the marginal attorneys' fee rates for each band of recovery should be higher for consumer class counsel than for

the third-party payor class counsel, who had negotiated a flat 22% rate. Id. at 978. Applying that concept here,

given the lower risks to counsel here than to class counsel in Synthroid and the absence of any market data other

than the broad ranges discussed earlier, I conclude that a reasonable and plausible ex ante negotiation here would

have resulted in something akin to the Synthroid fee structure awarded to consumer class counsel, with reduced

percentages of 5% to 7% at each potential band of recovery. Further, as discussed above, I believe a reasonable

ex ante negotiation here would have resulted in a lower percentage fee for in-kind than cash relief. Therefore, I

believe the following fee structure is a reasonable approximation of what an ex ante arms-length market transaction

would have produced in this action, as compared to that determined by the Court in Synthroid II:

Recommendation Synthroid II

Recovery Fee Percentage Recovery Fee Percentage

$ 0–10 million 25% $ 0–10 million 30%
In re Trans Union Corp. Privacy Litigation, Not Reported in F.Supp.2d (2009)

 © 2014 Thomson Reuters. No claim to original U.S. Government Works. 19

$10–20 million 20% $10–20 million 25%

$20–45 million 15% $20–46 million 22%

$45+ million 10% $46+ million 15%

In–Kind Relief 5%

Plugging these percentages into the $75 million cash recovery and the $34.6 million value of the in-kind relief

yields a total attorney fee award of $12.98 million.

Of course, it is possible that an actual negotiation might have resulted in a higher scale or a lower scale. It might

have yielded a formula resulting in something like the $10.83 million award in the Court's April 6 Order, or

something closer to the $18.75 million cap. But no one can know here what the market-based result would have

been in a transaction that never occurred. There are no market tables, Kelly Blue Books or Ebay auctions to

consult to gauge the going rate in 2001 for multi-district FCRA lawsuits. However, the above analysis yields a

plausible and reasonable market-based result consistent with the criteria set forth in the Seventh Circuit cases.

That is sufficient under the cases. In addition, the cross-checks discussed below confirm the reasonableness of

the recommended award.

E. Cross–Checks

*17 On an overall percentage basis, the award of $12.98 million represents 17.31 % of the $75 million cash

portion of the settlement, and 11.84% of the $109.6 total settlement amount (cash plus in-kind). These numbers

fall comfortably within the ranges suggested by Eisenberg and Miller (6.7% to 32.9% of the cash, 8.4% to 27.8%

of the total) and the auction cases (4.4% to 23.3% of the cash, 3.8% to 23.2% of the total). I recognize, as the

Court in Nilsen noted, “that the fact that my award falls within the range of other judicial awards serves mostly

to give me comfort against embarrassing comparisons.” 400 F.Supp.2d at 283 n. 41.

As a further check on the reasonableness of this recommended award of $12.98 million, I think it is useful to

run “cross-checks.” First, as a final exercise of ex ante imagination, I have tried to gauge how the hypothetical

plaintiffs' law firm would have evaluated the tiered percentages recommended above. Any rational firm engaged

in such an ex ante negotiation would want to estimate the opportunity cost of the engagement: How many hours

would it need to invest that might be more profitably spent elsewhere? What likely lodestar would be generated

and would the engagement probably provide a premium over the forecast lodestar to compensate for the risk? As

noted above, the plaintiffs' firm would probably have valued the case at about $20 million at the low end, $50

million in the middle and $75 to $100+ million at the high end. The tiering suggested above would yield a fee of

$4.5 million on a cash recovery of $20 million, $8.75 million on a cash recovery of $50 million, and $11.25 to

$13.75 million on a cash recovery of $75 to $100 million. At an assumed blended 2001 hourly rate of about $300

(which is probably generous), the lower recovery would support a projected hourly investment of about 15,000

hours (without multiplier) while the top recovery would support an hourly investment of 25,000 to 33,000 hours

(without multiplier). The hypothetical plaintiffs' firm would find a fair amount of cushion for these investments

of time and find the suggested tiering attractive in this case. 27

27 Here, Plaintiffs' Counsel reported a combined total of over 38,000 hours worked, but, as discussed below, that figure

is excessive.

As an additional cross-check, I turn now to an ex post analysis, based on the actual historical lodestars. I first

discuss the lodestars claimed by Plaintiffs' Counsel, and then I discuss my estimate of what the actual lodestars

would be after a more rigorous analysis, which I believe provides a more valid cross-check than simply taking

the claimed lodestars at face value.
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Many courts, including at least one court in this district, have used a lodestar cross-check against a percentage

fee award. See, e.g., In re Rite Aid Corp. Sec. Litig., 396 F.3d 294, 305 (3rd Cir.2005); Goldberger v. Integrated

Resources, Inc., 209 F.3d 43, 50 (2d Cir.2000); Abrams v. Van Kampen Funds, Inc., No. 01 C 7538, 2006 WL

163023, at *7–*8 (N.D.Ill. Jan.18, 2006) (Hart, J.).

The purpose of a lodestar cross-check is simply to determine whether a proposed fee award is excessive relative

to the hours reportedly worked by counsel, or whether the fee is within some reasonable multiple of the lodestar.

Rite Aid, 396 F.3d at 306 (“The lodestar cross-check serves the purpose of alerting the trial judge that when the

multiplier is too great, the court should reconsider its calculation under the percentage-of-recovery method....”);

Vizcaino, 290 F.3d at 1050 (“[T]he lodestar may provide a useful perspective on the reasonableness of a given

percentage award.”). 28 When used merely as a cross-check, the lodestar analysis can be “abridged.” Rite Aid,

396 F.3d at 305; see also id. at 306–07; Goldberger, 209 F.3d at 50.

28 But see In re Comdisco Sec. Litig., 150 F.Supp.2d 943, 948 n. 10 (N.D.Ill.2001) (“To be sure, when a fee award

is enormously disproportionate to the lawyers' expenditure of time ..., it may be useful for a court to express the

disapproval of that disparity in terms of pointing to a correspondingly staggering lodestar multiplier-a sort of Jacobellis

v. Ohio (‘I know it when I see it’) demonstration. But when the issue comes down to whether a multiplier of 2 or 5 or 7

(or what have you) is or is not ‘reasonable,’ so as to serve as some sort of check on the reasonableness of a percentageof-recovery fee award, candor compels recognition of the fact that the process has become wholly subjective....”).

*18 I believe there is a role for a lodestar cross-check, notwithstanding the statement in Synthroid II that the

efficiency (or lack thereof) of counsel should not be used “to reduce class counsel's percentage of the fund that their

work produced.” 325 F.3d at 979–80. Consistent with Synthroid II, the ex ante percentages above were derived

from the Synthroid II tiers and without regard to any lack of efficiency of counsel during the lawsuit. However, as

noted above, this case lacks the type of actual, arms-length agreement that “defined” the market in Synthroid, and

we were forced to engage in the imprecise estimation of the ex ante agreement. That approach relied on several

assumptions and widely dispersed data from other cases. The uncertainty here is greater than in Synthroid II. In

this context, then, there is a proper role for considering the actual hours spent in the case as a cross-check on the

proposed percentages. A wide divergence between the lodestar and the percentage might indicate a problem that

would warrant revisiting the assumptions underlying the percentage method. As discussed below, as it turns out,

there is no wide divergence here, and no reason to reconsider the percentages.

MDL Counsel, Liaison Counsel, Frey Counsel, and Louisiana Counsel reported a total lodestar of $18.25 million.

(Doc. 564–2 at 18.) Texas Counsel, after my request to remove time related to the attorneys' fee proceedings,

reported a lodestar of $1.49 million. (Texas Counsel's Response to Special Master's Request, Aug. 18, 2009, at

2.) Combined, all counsel reported a total lodestar of $19.74 million. The actual award of $12.98 million thus

represents a multiplier of 0.66 on the lodestar claimed by Plaintiffs' Counsel. This fractional multiplier does not

raise a red flag for me to suggest that the $12.98 million award is unreasonable for several reasons.

First, Plaintiffs' Counsel (except Texas Counsel), in their joint fee petition, acknowledged that their total fee

request of $15.1 million was significantly less than their claimed lodestar. Courts employing a lodestar crosscheck have entered percentage awards that did not fully compensate counsel for their claimed lodestar. See In

re Insurance Brokerage Antitrust Litig., MDL No. 1663, 2009 WL 2855855, at *32, *35 (3d Cir. Sept.8, 2009)

(lodestar multiplier of 0.4); Blackman v. O'Brien Envtl. Energy, Inc., No. Civ.A. 94–5686, 1999 WL 397389, at

*2 (E.D.Pa. May 12, 1999) (0.82 multiplier); Fanning v. Acromed Corp. (In re Orthopedic Bone Screw Products

Liability Litig.), No. 1014, C.A. 97–381, 2000 WL 1622741, at *8 (E.D.Pa. Oct.23, 2000) (0.62 multiplier).

Second, and more importantly, even without conducting a detailed lodestar analysis, it is readily apparent that

the lodestars claimed by Plaintiffs' Counsel are excessive. The 0.66 multiplier is, essentially, a fiction resulting
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from plugging an excessive lodestar into the denominator. While some courts take claimed lodestars at face value

for purposes of running the cross-check, see, e.g., Rite Aid, 396 F.3d at 307; Goldberger, 209 F.3d at 50; In re

Prudential Ins. Co. Am. Sales Practice Litig. Agent Actions, 148 F.3d 283, 342 (3d Cir.1998), courts are not

required to do so. Indeed, under the venerable principle “garbage-in-garbage-out,” the cross-check itself can have

little validity if the lodestar itself is invalid. Thus, “any lodestar cross check should be based on billings that have

some semblance of reasonableness.” In Re Keyspan Corp. Sec. Litig., No. 01 CV 5852(ARR), 2005 WL 3093399,

at *18 (E.D.N.Y. Sept.30, 2005) (reducing claimed fee lodestar by 20% to account for excessive rates, excessive

hours and failure to bill certain tasks at lower rates, resulting in a 1.42 multiplier as compared to 1.14 multiplier

based on claimed lodestar); Abrams, 2006 WL 163023, at *7–*8 (Hart, J.) (reducing claimed fee lodestar by about

40% to account for excessive hourly rates and top-heavy staffing, resulting in a multiplier of 1.88 as compared to

1.14 multiplier on claimed lodestar). I therefore consider the claimed hourly rates and hours billed to determine

an adjusted lodestar with “some semblance of reasonableness.”

*19 The lodestar reported by Plaintiffs' Counsel reflects a total blended hourly rate of roughly $514. 29 This

appears excessive relative to normal Chicago area rates (assuming Chicago market rates apply to all counsel,

which is debatable 30 ). For example, of the four Chicago law firms responding to a 2008 survey of the nation's

largest law firms by The National Law Journal, none reported a firm-wide average hourly rate of more than $500.

See A Nationwide Sampling of Law Firm Billing Rates, The National Law Journal (Dec. 8, 2008) (available at

http://www.law.com/jsp/nlj/PubArticleNLJ.jsp? id=1202426491559) (last visited Sept. 19, 2009). 31 Indeed, only

seven of the 127 law firms responding to the survey reported a firm-wide average hourly rate of more than $500. 32

And these firms represent the peak of the market. In a lodestar analysis, counsel is entitled to a reasonable, marketbased rate, not the highest rates that lawyers can cherry-pick from the market. Some recent decisions in this

district in statutory fee cases have approved of market rates substantially below those claimed by many Plaintiffs'

Counsel here. See, e.g., Dupuy v. McEwen, No. 97 C 4199, 2009 WL 2498197, at *5–*6 (N.D.Ill. Aug.13, 2009)

(Pallmeyer, J.) (approving 2007 attorney rates ranging from $230 to $520, with two experienced lead counsel

at $460 and $415) 33 ; Robinson v. City of Harvey, No. 99 C 3696, 2008 WL 4534158, at *7 (N.D.Ill. Oct.7,

2008) (Lefkow, J.) (finding reasonable and below market an hourly rate of $395 for “singularly formidable” civil

rights trial lawyer). And in 2004, this Court approved rates ranging from $175 to $375 for the Edelman firm, who

serve as local counsel for Texas Counsel. Zaghloul v. DaimlerChrysler Services, LLC, No. 03 C 4499, 2004 WL

2203427, at *2 (N.D.Ill. Sept.29, 2004).

29 MDL Counsel, Liaison Counsel, Frey Counsel, and Louisiana Counsel reported over 35,800 hours worked. Texas

Counsel reported over 2,600 hours worked. Dividing the $19.74 million total lodestar by the 38,400 hours claimed

by all counsel equals approximately $514 per hour.

30 One might question whether Chicago rates should be used, as opposed to the rates prevailing in each of the cities in

which the various lawsuits here were filed or of the cities in which each Plaintiffs' Counsel normally practices. The law

is not entirely clear on this point. In statutory fee shifting cases, the Seventh Circuit presumes that the attorney's actual

billing rate, rather than a local forum market billing rate, applies, although a court has some discretion to use forum

rates in some circumstances, such as where an attorney (like Ms. Wheelahan, whose practice is entirely contingent) is

unable to provide evidence of actual billing rates. See Mathur v. Bd. of Trustees of Southern Ill. Univ., 317 F.3d 738,

743–44 (7th Cir.2003). Matters are more complex in an MDL matter. This is not a single lawsuit. It may not make

sense for the hourly rates to depend upon the fortuity of the venue chosen by the MDL Panel, as opposed to the venues

in which the individual lawsuits were filed or the “hometown” rates of Plaintiffs' Counsel. However, since I am merely

looking to the lodestar as a cross-check against the market-mimicking application of a percentage recovery, and not

rigorously examining the hours and rates and each of the dozens of counsel from across the country, my simplifying

comparison to a single market is not unreasonable. Cf. In re “Agent Orange” Product Liability Litig., 818 F.2d 226,

232 (2d Cir.1987) (“[W]e conclude that, in an exceptional multiparty case such as this, where dozens of non-local

counsel from all parts of the country are involved, public policy and administrative concerns call for the district court
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to be given the necessary flexibility to impose a national hourly rate when an adequate factual basis for calculating the

rate exists.”); Eli Lilly & Co. v. Zenith Goldline Pharmaceuticals, Inc., 264 F.Supp.2d 753, 764 (S.D.Ind.2003) (MDL

cases may justify use of a single “national” rate scale). For present purposes, a comparison to the Chicago market,

with which I am most familiar, is not unfair either to Plaintiffs' Counsel or the class. See In re Folding Carton Antitrust

Litig., 84 F.R.D. 245, 264–65 (N.D.Ill.1979) (adopting a report recommending that “a proper hourly rate structure for

a national class action would reflect the rates prevalent for attorneys in the Chicago Metropolitan Area”).

31 Jenner & Block, one of the four responding Chicago firms, did not report a firmwide average. It did, however, report

an average billing rate of $616 for partners, and $393 for associates. Brinks Hofer Gilson & Lione reported a firmwide

average billing rate of $392, Vedder Price reported a firmwide average billing rate of $385, and Winston & Strawn

reported a firmwide average billing rate of $448.

32 Though I note that two of those seven, Milwaukee firm Foley & Lardner ($508/hour) and New York firm Loeb &

Loeb ($534/hour) do have offices in Chicago.

33 Disclosure: I represented plaintiffs' counsel regarding the fee petition in Dupuy, and my 2007 hourly rate of $410 was

among the rates approved by Judge Pallmeyer. My 2009 rate is $440.

A comparison to the so-called Laffey Matrix, adjusted for the Chicago market, also suggests that a total

blended hourly rate of $514 is too high. The Laffey Matrix is a chart of hourly rates for attorneys of varying

experience prepared and updated by the Civil Division of the United States Attorney's Office for the District of

Columbia. See Laffey Matrix 2003–2009 (available at http:// www.usdoj.gov/usao/dc /Divisions/Civil_Division/

Laffey_Matrix_7.html) (last visited Sept. 19, 2009). Although the Laffey Matrix was designed for use in statutory

fee-shifting cases, see id. (explanatory note 1), it has been used in lodestar cross-checks of awards in common

fund cases. See, e.g., Martin v. FedEx Ground Package Sys., Inc., No. C 06–6883, 2008 WL 5478576, at *6–

*8 (N.D.Cal. Dec.31, 2008).

34 Because the Laffey Matrix is tailored to the Washington D.C. market, an upward

adjustment of 1.1% is appropriate. 35 This adjustment yields a range of $227 per hour for attorneys with one to

three years of experience, to $470 per hour for attorneys with over twenty years of experience. As with the National

Law Journal Survey results, the adjusted Laffey Matrix suggests that a total blended hourly rate of $514 is too high.

34 Judge Lefkow also considered the Matrix in reviewing the hourly rates for a statutory fee award in Robinson, supra.

35 The 1.1% figure comes from comparing the U.S. Office of Personnel Management's 2009 General Schedule Locality

Pay Tables for Chicago and Washington D.C., available at http:// www.opm.gov/oca/09tables/indexGS.asp. See

generally In re HPL Techs., Inc. Sec. Litig., 366 F.Supp.2d 912, 921–22 (N.D.Cal.2005) (adjusting Laffey Matrix to

San Francisco market).

*20 The excessiveness of the blended rate becomes more apparent when one makes a brief granular inspection

of claimed rates of individual lawyers and firms. Louisiana and Texas Counsel provide clear examples. Ms.

Wheelahan, who logged most of the hours claimed by Louisiana Counsel, claims an hourly rate of about $625.

Even if we assume Chicago rates apply to her, as opposed to something closer to the hourly rate of $225 approved

in 2005 by the court in her home district, see White v. Imperial Adjustment Corp., No. Civ.A. 99–3804, 2005

WL 1578810, at *8 (E.D.La. June 28, 2005), and see n. 15 above, it is likely that a reasonable Chicago market

rate for her would be at least 25–30% lower. Similarly, the claimed rates of Houston lawyers Caddell ($725),

Chapman ($600), and Fein ($450), are about 20% or more above what I would recommend in a lodestar analysis

based on their respective years of experience. Indeed, the Chicago rates of Liaison Counsel, Ms. Saunders ($575),

and local counsel for Texas Counsel, Mr. Edelman ($550), are in the ballpark of reasonableness for attorneys

of their experience, which coincides with the $575 rate of Texas Counsel's Mr. Toups. Finally, while the rates

of some MDL Counsel appear reasonable and may be below the Chicago market (e.g., Boise attorney and Frey

counsel, John Zarian, who claims a $395 rate and is one of the few counsel in the case who has clients actually

paying that rate), other claimed MDL Counsel rates are too high and would warrant a reduction similar to that of

Texas Counsel. For example, the blended hourly rate of The Righetti Law Firm was nearly $670 and Coughlin

Stoia nearly $517.
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Turning from rates to claimed hours, it is clear that deep cuts in hours would be made if a formal lodestar analysis

were used. The most obvious case is the more than 7,000 hours claimed by Ms. Wheelahan. Even after eliminating

the obvious excesses identified by the Court in its April 6 Order (the travel time of about 400 hours and hours

for clerical tasks), the hours appear excessive. There are vast numbers of hours spent on research and writing,

for example. Not only is it likely that fewer hours could have been expended, much of that time should have

been billed at lower rates than the single “partner-level” rate she charges for all of her tasks. 36 I conservatively

estimate that a detailed review of Ms. Wheelahan's claimed hours would result in a reduction of at least 25–33%,

and possibly much more. See White, 2005 WL 1578810, at *15–*16 (reducing Ms. Wheelahan's research and

writing time by 25% and reducing total time by about 34%). 37

36 Sometimes partners can do research more efficiently than associates, due to greater experience or familiarity with a

case. However, it is often the case that research tasks can and should be done by associates at lower rates, and feepaying clients sometimes insist on that. A practitioner is free to make a business decision not to hire associates, but

neither a paying client, nor a court acting as a fiduciary to a class, must accept partner-level rates for associate-level

work where such work can be more efficiently done at the lower level.

37 I note that this reduction gives Ms. Wheelahan the benefit of a substantial doubt. I have not deducted from her lodestar

the more than 1,300 hours she claims to have spent on the state court Andrews Action. MDL Counsel point out that

in persuading this Court to remand that action to Louisiana state court in 2003, Ms. Wheelahan “ ‘disclaim[ed] any

right to recover attorney's fees in the state law [complaint],’ either from defendant or from any recovery by the class

members by way of common fund or otherwise.” Dec. 3, 2003 Op. and Order at 4. Ms. Wheelahan acknowledges

this disclaimer, but contends that the waiver was only of the namedplaintiff's right to seek a statutory fee award,

which would have increased the amount in controversy, not counsel's right to seek a fee from a common fund, which

does not bear on the amount in controversy. Further, she argues that the Stipulation of Settlement put the Andrews

lodestar back in play because the Stipulation's definitions included that case within the settled “Actions” and it further

provided that the fee award would cover fees “incurred in connection with prosecuting and settling the Actions.” Doc.

462–3 at 24, § 4.1. These definitions, however, do not answer whether fees, if previously waived, can be unwaived,

particularly where they were arguably waived in order to convince a court that federal jurisdiction was lacking. This

raises a question of judicial estoppel, which, if valid, would reduce the claimed Louisiana lodestar by about another

$800,000. However, since I am only performing a rough cross-check, I am giving Louisiana Counsel the benefit of

the doubt and am not resolving the issue or making any deduction.

While Texas Counsel made some use of professionals billed at lower rates where appropriate, my cursory review

of their billing records reveals some duplication, top-heaviness and excess that would result in moderate hourly

cuts of at least 10% on top of the rate cuts of about 20%. The same is true of MDL Counsel, and one could

legitimately question whether substantial cuts would be made in the hours they expended unsuccessfully pursuing

the First and Second Proposed Settlements. Finally, all counsel had duplication in the parallel motions for final

approval of the Final Settlement, which resulted from the failure of counsel to agree on a common approach.

Without assigning blame for that result, I nevertheless am confident that a detailed lodestar analysis would not

charge the class for the consequences of counsels' failure to agree, and substantial reductions would be made.

*21 For the foregoing reasons, the more realistic and reasonable lodestar of Plaintiffs' Counsel is well below

the claimed amount of $19.74 million. While Louisiana Counsel claim a lodestar of about $4.7 million based on

7,524.6 hours, the reductions in hours and rates noted above would result in a total lodestar reduction of at least

50–60%, to around $1.88 to $2.35 million. Texas Counsel's claimed lodestar of $1.49 million would probably be

reduced by about 25–33%, to around $990,000 to $1.12 million. The claimed lodestar of about $12.9 million by

MDL/Frey Counsel would also likely be reduced by about 25–33%, to about $8.6 to $9.7 million. Thus, adding in

the $550,000 agreed payment to Liaison Counsel (whose lodestar was claimed to be about $613,000) the lodestar

that reflects a “semblance of reasonableness” would range from about $12 to $13.7 million (and quite possibly

lower). As compared to the recommended percentage-based award of $12.98 million, this yields a multiplier
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of 0.95 to 1.08. Accordingly, I am satisfied that the recommended fee award of $12.98 million derived from

application of the market-mimicking approach is comfortably within the range of reasonableness.

F. Allocation

1. The amounts requested by counsel

“Allocating a limited pot of common benefit fees among numerous counsel, all of whom are talented and capable

attorneys and many of whom have made a significant contribution to the ultimate success of this case, is an

unenviable task that is sure to lead to hurt feelings and bruised egos. Nevertheless, it has to be done.” Turner

v. Murphy Oil U.S.A., Inc., 582 F.Supp.2d 797, 812 (E.D.La.2008) (internal citation omitted). To avoid the

“unenviable task,” I gave Plaintiffs' Counsel advance notice that I would recommend a total fee award of $12.98

million, so that they could make another attempt at agreeing to an allocation. After the attempt failed, I requested

briefs.

The allocation briefs were remarkable for the size of the requests. While I expected counsel to aim high, I did

not expect them to ask for more than they had previously requested from the Court. Nor, in light of the $12.98

million pie they were asked to divide, did I expect them collectively to shoot for more than the settlement cap of

$18.75 million. Yet they did ask for more. Much more.

Most remarkable was the swelling of Texas Counsel's request. In their fee petition to the Court, Texas Counsel

requested $2,850,000 in fees. They claimed their lodestar was $1,613,578.75. (Doc. 570–2 at 15.) This request was

made when it was unknown what total fee the Court might award, subject only to the overall cap of $18.75 million.

When I reviewed Texas Counsel's billing records (which had not been provided to the Court), I determined that

they had incorrectly included in their lodestar a substantial amount of fees related to the attorneys' fee proceedings,

which are not recoverable from common fund awards. See April 6 Order at 7. I asked them to revise their billing

statement to eliminate such time. Their revised, adjusted claimed lodestar dropped to $1.49 million. Even though

the funds potentially available for allocation had dropped from $18.75 million to $12.98 million, and their claimed

lodestar had fallen by about $121,000, Texas Counsel increased their requested share of the fees by nearly a million

dollars, from $2,850,000 to $3,729,212.50. The claimed lodestar multiplier implicit in this request increased from

1.77 in the initial request to 2.50. Texas Counsel provided no explanation for this tacit amendment of their original

fee petition, nor any explanation for why their share should have increased by $1 million in the face of a shrunken

available pie.

*22 Not to be outdone, Louisiana Counsel's allocation brief requests $7,915,000, which represents about 61 % of

the total recommended fee award. As part of that request, as if to provide a new definition of the term “chutzpah,”

Louisiana Counsel claims an entitlement to the entire increase of about $2 million between my recommended

award and the award in the Court's vacated April 6 Order. Louisiana Counsel attributes the increase entirely to

the Rule 59(e) motion she filed, which is not only incorrect, but ignores her involvement in the ethical issues

prompting my appointment.

The allocation position of MDL/Frey Counsel, who consist of about thirty law firms, is more realistic under the

circumstances. They seek $9,380,000, about 72% of the total. All told, the fees sought by Plaintiffs' Counsel,

including the $550,000 allocated to Liaison Counsel by agreement, total $21,574,212.50, nearly $3 million over

the settlement cap and nearly $9 million more than the pie they were asked to divide. Clearly, something has to

give.

The following chart summarizes the proposed allocations of counsel and the recommended allocation I determine

below. 38
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38 The figures in the chart do not include the $550,000 allocated to Liaison Counsel or one-half of the Special Master's

fees and expenses (which I had told them to assume would be about $50,000, and turned out to be $55,638), and,

thus, do not add up to $12.98 million. Texas counsel only suggested a figure for themselves, without recommending

allocation between MDL and Louisiana Counsel. Louisiana and MDL Counsel proposed allocations among all counsel.

Louisiana's figures apparently did not subtract anything for Special Master fees.)

MDL Louisiana Texas Total

MDL Proposal $9,380,000 $1,800,000 $1,200,000 $12,380,000

Louisiana Proposal $3,115,000 $7,915,000 $1,400,000 $12,430,0 00

Texas Proposal N/A N/A $3,729,212.50 N/A

Special Master's

Recommendation

$7,836,683 (63.33%) $2,722,360 (22%) $1,815,319 (14.67%) $12,374,362 (100%)

I approach the allocation issue mindful of my limitations. Of all of the relevant participants (the Court, Plaintiffs'

Counsel, and me), I know the least about the history of the case and the relative contributions of counsel to the

outcome. I was not there. I have gleaned a fair amount from review of the court record, the billing records, some

of the statements of counsel made in e-mails produced to me, and the allocation briefs. But this after-the-fact

education is no match for the Court's immersion in the case and knowledge of the participants. Nevertheless,

sometimes the perspective of an outsider has value, and I hope the following analysis is helpful to the Court.

2. Allocation standards

I directed counsel to include in their allocation briefs citations to cases setting forth the standards applicable to

the allocation analysis. Only MDL Counsel attempted to comply with this request, and the authority they cited

was not directly apposite. They cited Sutton, 504 F.3d at 692–93, which reaffirmed the Synthroid standards that,

in approximating the ex ante market determination of fees at the outset of the litigation, the Court should consider

factors such as the “risk of nonpayment,” “amount of work necessary to resolve the litigation,” and “the stakes

of the case.” But the allocation analysis here cannot be based on the ex ante approach of Synthroid and Sutton. In

some cases, it might be possible to approximate what allocation terms might have been negotiated at the outset of

a lawsuit, but here no one would have predicted that outside lawyers would parachute into the case, successfully

object to a proposed class settlement, become involved in negotiating the final settlement, and earn an entitlement

to share in the common fund recovery. Little can be said other than it would reasonable to assume that the class

would agree at the outset that the allocation be based on relative contributions of counsel to the ultimate recovery.

Beyond that broad generalization, the allocation analysis must be done on an ex post rather than ex ante basis.

*23 “There is very little case law concerning the allocation of attorneys' fees among co-counsel.” In re FPI/

Agretech Securities Litigation, 105 F.3d 469, 473 (9th Cir.1997). Relevant criteria include whether the attorney's

services benefitted the fund by helping create, increase, protect or preserve it, as well whether the allocation is

reflective of the relative work performed (i.e., lodestars). Id. See also id. at 474 (“we hold that the relative efforts

of, and benefits conferred upon the class by, co-counsel are proper bases for refusing to approve a fee allocation

proposal”). This is an equitable determination as to which the Court necessarily has broad discretion and which

requires no more than a concise explanation. Id. at 473. Some of the ex ante factors noted in Sutton thus appear

to remain relevant after all to the ex post analysis: risk of nonpayment, quality of performance and amount of

work (lodestar). All of these relate to the overarching factor noted above: the extent to which each group of

lawyers contributed to the ultimate success of the case. Thus, the analysis below will focus on this question of

“contribution,” with attention paid to additional factors such as relative risk and lodestars. I note that Plaintiffs'

Counsel implicitly assumed that “contribution to the outcome” is the most important inquiry, since that was the

focus of their briefs.

3. Allocation analysis
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The competing groups of counsel gave widely divergent accounts of their relative contributions to the overall

settlement. Louisiana Counsel and Texas Counsel rely heavily on the fact that they successfully objected to the

prior proposed cash settlement of $20 million, which resulted in the ultimate realization of $55 million of additional

cash relief and about $14 million of “enhanced” in-kind relief. They argue that MDL Counsel is entitled to little

or no credit for fees based on the additional settlement value Louisiana and Texas allegedly procured for the class.

Their agreement ends there. As for allocating fees between them, Louisiana and Texas Counsel train their fire on

each other. Louisiana Counsel claims that they (primarily Ms. Wheelahan) bore most of the risk and did most of

the work. They argue that Texas Counsel were opportunistic latecomers, who stood on the sidelines, jumping into

the fray in earnest only after the Second Proposed Settlement was rejected and a bigger settlement and ultimate

payday for counsel were a virtual certainty. (MDL Counsel also point out that about 70% of Texas Counsel's hours

were incurred after a March 4, 2008 status hearing, in which the landscape and risks changed dramatically.) In

contrast, Texas Counsel claims that Louisiana Counsel is writing revisionist history, and is ignoring the substantial

contributions they made to the ultimate outcome, which they made at the behest of Louisiana Counsel, who

repeatedly praised their efforts in e-mails.

MDL Counsel, on the other hand, acknowledge the contributions of Louisiana and Texas Counsel to the ultimate

outcome, but argue that they contributed substantially as well to the final result notwithstanding their unsuccessful

promotion of the earlier proposed settlements. They point out that they began filing their initial lawsuits in 1998

(Frey ) and 1999, when the risk was greatest and outcome least certain. They sought and achieved the MDL

reassignment. They conducted extensive discovery. They catalog various additional tasks they performed. As for

the failed First and Second Proposed Settlements, they say they took a reasonable, albeit unsuccessful, position,

based on the then-current risk analysis, which included the fact that the Court had held in 2002 that it would

not certify a national “target marketing” class due to the potentially catastrophic liability it would impose on

Trans Union and the fact that the Magistrate Judge had supervised the mediation that resulted in the proposed

settlements. It was not until March 4, 2008, after the Court adopted the Magistrate Judge's recommendation that

the Second Proposed Settlement be rejected, that the landscape changed. At that hearing, the Court stated that

it was open to reconsideration of the denial of a national target marketing class, Mar. 4, 2008 Tr. at 8; and that

Trans Union needed to put “a lot more money on the table.” Id. Although not noted by MDL Counsel, the Court

had suggested a few months earlier that class certification law had evolved since 2002, and reconsideration of the

denial of a national class might be warranted. Jan. 15, 2008 Tr. at 7 (“my original opinion on class certification is

going to be influenced by later case law from this circuit that calls into question my original conclusion, because

I think it was based on current case law at the time. But things have changed since then.”) In any event, MDL

Counsel contend that the steep increase in the value of the settlement resulted primarily from these comments

by the Court, which had much more influence on increasing the settlement value of the case than the efforts of

Louisiana and Texas Counsel, and the ultimate outcome resulted primarily from the foundation MDL Counsel

had laid by prosecuting the case up to that point.

*24 I think the truth lies somewhere between these positions. I agree with Louisiana and Texas Counsel that they

are entitled to credit for being “right” about the First and Second Proposed Settlements and judging that this case

had much greater value than MDL Counsel had thought. They reached that correct conclusion before the Court

changed the landscape in early 2008 with comments about potentially reconsidering class certification. Indeed,

internal e-mails submitted by Texas Counsel indicate that Texas Counsel had recognized the evolution in class

action law and were urging the filing of a reconsideration motion. However, I disagree that their correct analysis

vested them with an entitlement to 100% credit for the additional $69 million ($55 million cash and $14 million

enhanced in-kind relief) in settlement value that was realized. MDL Counsel are right that they laid the foundation

and created much of that value.
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The argument of Louisiana and Texas Counsel proves too much and would, in my judgment, result in a windfall

to them. Their premise is that the first two proposed settlements did not reflect the true value of the case for the

class. But who “created” that extra value? It was principally the efforts of MDL Counsel, enhanced somewhat

later by the Court's comments in early 2008, and also by the certification of a target marketing class in Louisiana.

The argument of Louisiana and Texas Counsel tacitly acknowledges that the value was already there when they

made their objections. Under their logic, MDL Counsel should be deemed to have forfeited any right to share

in the value MDL Counsel created because they miscalculated the value or did not anticipate the Court's later

comments about reconsidering a nationwide class. I do not believe such a forfeiture would be fair or reasonable.

Louisiana and Texas Counsel may have correctly adduced and helped unlock the true enhanced value in this case,

but they did not solely create it. MDL Counsel remain entitled to share in the value of the case above and beyond

the original $20 million in cash and $20 million of in-kind value embodied in the rejected settlement.

That brings us, again, to the hard part, the actual calculation of an allocation. As with the determination of the

total fee award, this cannot possibly be done with scientific precision. Rather, it is based on broad estimates. In

light of the foregoing discussion, I assign the relative contributions of counsel to the settlement as follows.

Regarding the cash value of the settlement, $75 million, MDL Counsel are entitled to full credit for having created

the first $20 million of value through their efforts leading up to the prior proposed settlements. Under the analysis

above, it would also be fair to give them credit for 50% of the additional $55 million in cash settlement value

ultimately realized. Louisiana and Texas Counsel therefore get credit for the remaining 50% of the additional $55

million in cash value realized through their objections and subsequent efforts. Thus, MDL Counsel get credit for

“creating” 63.33% of the total cash settlement value. 39

39 This is calculated as follows: 100% credit times $20 million in value, plus 50% credit times $55 million in value,

yields $47.5 million in created cash value. That is 63.33% of the $75 million cash recovery.

*25 That leaves 36.67% of cash value created jointly by Louisiana and Texas Counsel, to be divided between

them. I recommend a 60/40 split, respectively, resulting in an assignment of 22% “credit” to Louisiana Counsel

and 14.67% to Texas Counsel. I am persuaded by the arguments of Texas Counsel, supported by time records and

contemporaneous e-mails, that they came into the case at the behest of Louisiana Counsel, in part because of the

additional firepower and credibility they would bring to her status as lonely objector; that Ms. Wheelahan was

responsible in part for their relatively passive role before the rejection of the Second Proposed Settlement; and

that they contributed substantially to the final result, including by conducting essential legal analysis and fronting

the expenses of hiring helpful expert witnesses.

Louisiana Counsel exaggerate their contribution relative to that of Texas Counsel. The ratio Louisiana proposes,

of about 5.5 to 1, is excessive. A ratio of 3 to 2 (a 60/40 split) more accurately and fairly reflects their relative

contributions, including the fact that Louisiana Counsel were involved longer, bore greater risk, secured a class

certification in Andrews, and fought for a time from the difficult and lonely position of being a solitary objector.

Ms. Wheelahan gets credit for correctly determining that the initial settlements were inadequate and for bringing

Texas Counsel into the case. Notwithstanding her unorthodox ways, and her alienation of her co-counsel and,

sometimes, the Court and the Magistrate Judge, the simple and undeniable fact remains that she was instrumental

in increasing the class cash recovery by $55 million. Results count, and she delivered. Thus, allocating a somewhat

larger share to Louisiana Counsel than to Texas Counsel is appropriate under the circumstances.

Next, I conclude that the same percentages should apply to assigning “credit” for the in-kind portion of the

settlement. Texas Counsel suggest that their “credit” (and, implicitly, that of Louisiana Counsel) should be based

on the value of about $14 million in “enhanced” in-kind relief added to the final settlement. One could try to derive

different percentages to apply to the in-kind portion of the recovery, but I conclude that the foregoing percentages
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(63.33%, 22%, 14.67%), being themselves rough approximations, are close enough to the relative contributions

to the in-kind portion of the award. There is no reason to complicate the analysis further by estimating different

percentages for that portion. Thus, those are the percentages I recommend for assigning “credit” for relative

contributions to the total settlement value. The allocation figures set forth in the table on page 33 above represent

a simple application of these percentages to the $12,374,362 recommended fee award remaining after deducting

fees of Liaison Counsel and Special Master.

As with the determination of the total fee award, a cross-check of the lodestars against these figures is useful to

determine whether any assumptions in the analysis might warrant reconsideration. Earlier, I concluded that after

applying reductions for appropriate hourly rates and elimination of excessive or duplicative time, the lodestars

would be roughly as follows (and perhaps lower): MDL, $8.6 to $9.7 million; Louisiana, $1.88 to $2.35 million;

Texas $990,000 to $1.12 million. The allocation suggested above is reasonable when compared to these estimated

lodestars. MDL Counsel would receive a slight discount on their adjusted lodestar. The lack of an enhancement

fairly accounts for the misjudgment they made regarding the proposed settlement. In contrast, my recommended

allocation would give each of Louisiana and Texas Counsel moderate multipliers on their approximate adjusted

lodestars. Although they had less risk than MDL Counsel (especially Texas Counsel), they “bet right” on the

earlier proposed settlements, so some enhancement over lodestar is appropriate under the circumstances.

*26 MDL Counsel have asked me to recommend that the Court enter separate judgments with respect to the fees

allocated to each of the counsel groups because they expect Ms. Wheelahan to appeal any award lower than her

request. I sympathize with the motivation for their request. They want to get paid. But I do not see how separate

judgment orders would give MDL Counsel the realistic option of avoiding participation in an appeal and getting

paid their fees. Unless Louisiana Counsel were to limit the appeal to seeking for themselves fees in excess of

the $12.98 million I have recommended, any appeal will almost certainly implicate the allocation issues and drag

MDL Counsel in. Also, this request may ultimately touch upon Rule 62 matters such as appeal bonds or stays

pending appeal, and as such, I decline to make any recommendation regarding the form of judgment(s) unless

asked to do so by the Court.

III. INVESTIGATION OF THE WHEELAHAN NOVEMBER 19 E–MAILS AND OTHER ETHICAL

ISSUES

A. Summary of the Issue and Recommendation

Attached to the Court's April 6 Order was a copy of a series of e-mails sent on November 19, 2008 by Louisiana

Counsel Ms. Wheelahan to Texas Counsel Mr. Toups. Texas Counsel had given the e-mails to the Magistrate

Judge during an ex parte mediation session on November 20, 2008. Because of the ethical issues raised in the emails and their potential implications for the certified settlement class, the Magistrate Judge subsequently gave a

copy of the e-mails to the Court. The Court characterized the e-mails as “reprehensible.” April 6 Op. at 8. As part

of its assignment to me, the Court directed me to “investigat[e] any ethical issues raised by Louisiana counsel's ...

communications.” June 11 Order (Doc. 535) at 2.

When I first read the e-mails my initial reaction is that Ms. Wheelahan's conduct was sanctionable. However,

I came to view this as a close question. While I agree that the e-mails were “reprehensible,” as I understand it,

my assignment is not to evaluate the e-mails on a tactical, logical or civility level, but rather to investigate and

recommend whether any Court Rules or ethical or fiduciary duties were broken such that a sanction should be

imposed on Ms. Wheelahan. In carrying out this task, my principal concerns were whether there was ever any

real danger to the rights that had been secured for the settlement class, any serious violation of applicable rules of

professional conduct, or any serious affront to the integrity and administration of the judicial process. As I explain

below, based on my review of the documents produced to me by counsel, my examinations of Ms. Wheelahan

and Mr. Toups, my inquiries of other counsel for plaintiffs and Trans Union, and my analysis of the context in
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which the remarkable e-mails were sent, while I do not condone her conduct in any respect, I do not recommend

that the Court sanction Ms. Wheelahan in connection with the sending of the e-mails or conduct relating to the

subject matter of the e-mails.

B. Ms. Wheelahan's Procedural Objections

*27 Ms. Wheelahan raises several procedural objections to the ethics inquiry. First, Ms. Wheelahan questions

the propriety of Texas Counsel giving a copy of the November 19 e-mails to the Magistrate Judge. She claims that

doing so violated Local Rule 83.5, which provides generally for the confidentiality of statements made in “ADR”

proceedings. I disagree, but, more importantly, the Court has already implicitly rejected this argument. See May

1, 2009 Order at 2 (Doc. 613) (denying Motion of Louisiana Counsel to Strike from the Record Confidential

Materials based on LR 83.5). The shroud that generally covers settlement communications does not and cannot

envelop potential ethical violations or other misconduct that may have occurred in such proceedings. Having

received the November 19 e-mails on November 20, it was proper for Texas Counsel to give a copy promptly to

the Magistrate Judge. Although, as discussed below, Texas Counsel were perplexed as to what Ms. Wheelahan

was up to, they rightly concluded that, read literally, the e-mails did appear to raise a potential violation of ethical

duties owed by an attorney to the same certified settlement class they represented. In that circumstance, it was

appropriate to disclose that communication to the tribunal with jurisdiction over the settlement and duties to the

class. I also disagree with Ms. Wheelahan's assertion that Texas Counsel's motivation for disclosing the e-mails

was entirely tactical. Texas Counsel were motivated, at least in part, by ethical rather than parochial concerns. 40

40 Contrary to Mr. Toups's testimony (Toups Tr. 77–78), however, I doubt they were motivated entirely by duty: I think

it likely that they also believed that giving the e-mails to the Magistrate Judge might produce a collateral benefit to

them in the negotiation process or litigation over fees thereafter. Further, it would have been a better practice for Texas

Counsel to have informed Ms. Wheelahan that they had given the Magistrate Judge a copy of the e-mails, although

Mr. Toups testified that they believed that the Magistrate Judge had discussed the e-mails separately with her and they

therefore thought there was no need to notify her.

Second, Ms. Wheelahan asserts that the investigation of her alleged ethical transgressions was required to be

conducted in confidence pursuant to Local Rule 83.25(e). She misreads the Rule. The confidentiality provision

in that Rule pertains to “[p]roceedings before the Executive Committee.” Such proceedings concern whether

“discipline” should be imposed on a lawyer practicing in this district.

The term “discipline” shall include disbarment, suspension from practice before this

Court, reprimand or censure, and such other disciplinary action as the circumstances may

warrant, including, but not limited to, restitution of funds, satisfactory completion of

educational programs, compliance with treatment programs, and community service. The

term discipline is not intended to include sanctions or contempt.

Local Rule 83.25(a)(3) (emphasis added). Local Rule 83.25(c) and the Committee Comment also make clear that

the rules are not intended to usurp the authority of a judge over conduct in proceedings before him or her. While

the Court could have chosen to refer this matter to the Executive Committee to investigate whether “discipline”

is appropriate, it was not required to do so. It plainly had not been stripped by Local Rule of its inherent authority

to investigate whether to “sanction” a lawyer for a possible ethical transgression, occurring under the auspices of

a mediation conducted by a Magistrate Judge, which had implications for a settlement class that the Court had

certified and to which it owed fiduciary obligations. The e-mails also had potential implications for the fee award

and allocation questions at issue before the Court, since a full or partial fee forfeiture might have been an available

sanction if Ms. Wheelahan had actually engaged in a “clear and serious violation of duty to a client.” Restatement

(Third) of the Law Governing Lawyers, § 37 (2000).
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*28 Finally, Ms. Wheelahan objects that the Court publicly aired the e-mails and criticized her without prior

notice and an opportunity to explain her position regarding the e-mails and other matters cited by the Court.

However, the Court imposed no sanction, vacated the April 6 Order containing the criticism, and appointed a

Special Master to investigate the ethical issues. Ample notice and process have been afforded Ms. Wheelahan.

Throughout my assignment, I have allowed Ms. Wheelahan to present whatever evidence and arguments she

wanted in connection with my investigation and report, and she was represented by counsel for at least part of

the proceedings before me.

C. Description of the Relevant E–Mails

The following facts are drawn from the November 19 e-mails and Ms. Wheelahan's testimony. The relevant e-mail

string contains four e-mails, written seriatim by Ms. Wheelahan and sent to Mr. Toups without any intervening

response. She acted alone. She had no input from any other counsel. She thumbed the first three on her BlackBerry

while having a solitary late dinner the night of November 19, 2008. This followed a long and frustrating mediation

session conducted by the Magistrate Judge, during which he tried to facilitate an agreement regarding the amount

and allocation of fees among the various groups of Plaintiffs' Counsel. The settlement talks were stalling, and Ms.

Wheelahan was particularly upset that Texas Counsel's position was higher than a lodestar she considered already

inflated, while she was being asked to take less than what she considered to be her lodestar and her contribution

to the success of the lawsuits.

Although the printed document states that the first three e-mails were sent during the wee hours of November 20,

it appears there was a problem with the clock on her BlackBerry. I find credible Ms. Wheelahan's testimony that

she typed the first three messages during her late dinner, probably between 9 and 10 p.m. She then apparently

forwarded the three e-mails to her America Online e-mail address, and sent a fourth e-mail shortly before midnight

to Mr. Toups from her laptop in her Chicago hotel. Mr. Toups did not see the e-mails until the next morning.

The first two e-mails, which are fairly innocuous, state Ms. Wheelahan's displeasure with the then-current state of

the fee negotiations. She wanted to persuade Texas Counsel to reduce their requested share of the fee pie, which

she felt was not only inflated, but unfair relative to her contribution to the class settlement outcome. She drank at

least three glasses of wine at dinner while sending the e-mails, and it is apparent that her frustration with the day's

events increased. The third e-mail upped the temperature from the first two. It said:

But here's what can happen. The 7th van [sic ] find that class claims for statutory. Damages

[sic ] were abandoned after cert. denied in 2002 when MDL coins [sic ] didn't move to

certify them, and cert of the punitives was denied in 2005. Leaving no live class claims.

Then I'll amend my LA suit to add FCRA claims and settle w TU for less than 75M but

plenty. More to me than 4.5.

*29 This e-mail, on the surface and standing alone, is illogical in the context of the negotiation, since it does

not make sense that the outcome of the objectors' appeal should affect the settlement position of Texas Counsel

in the fee negotiations. By itself this e-mail does not raise ethical red flags, since it does not overtly threaten to

undermine the class settlement. The fourth e-mail, on the other hand, expanded on the third, and gave rise to this

investigation (italics added):

And the more I think about this, the better it's looking to me. The 7th rejects the settlement,

on a motion to dismiss, and there are then no live class claims that can be certified, because

the statute has run on them. LA asserts additional claims that relate back to our original

filing in 2002 for the co-extensive LA class, and we settle with TU for around 40M. TU

saves a pile of money, and we get paid in a very friendly LA court, 25% of 40M. So my LA

co-counsel get 3M, and I get 7M. And TU saves 35M, and their lawyer looks great. And
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the MDL counsel who abandoned the statutory damages claims, and failed to certify the

punitives, are left with an Illinois class of firm offer claims that they cannot prove up, bec

they are not and never were classwide violations—and TU will not settle them. Tell me why

4.5M shd look better to me than that scenario?

The meaning of this e-mail is plain: it purports to threaten Texas Counsel. As the Court put it, it “seem[s] to

express an intention to manipulate the court proceedings in connection with the settlement for the sole purpose

of augmenting the fee award.” April 6 Order at 8. Ms. Wheelahan, who was then working on a motion to dismiss

the pending appeal, appears to be threatening to somehow cause the Seventh Circuit, via her motion to dismiss,

to reject the settlement. Because the settlement had extended the limitations period for many claims, its rejection

would put limitations issues back in play. Ms. Wheelahan's Louisiana state case, in which a “target marketing”

class had been certified, did not present the same limitations problems. Thus, her e-mail suggested that the rejection

of the MDL settlement might actually be “better” for her (and Trans Union) than the $4.5 million fee then on

the table in the negotiations, since she claimed she could make a deal with Trans Union in Louisiana that would

provide less money for nationwide class members and more attorneys' fees for her. The e-mail does not specify

how a motion to dismiss would cause the Seventh Circuit to reject the settlement, but other e-mails sent before

and after this e-mail (discussed later) establish that she was contemplating raising the statute of limitations (viz.

the objectors) in a motion to dismiss the appeal, which she thought could prompt the Seventh Circuit to sua sponte

reject the settlement on jurisdictional grounds.

D. Ms. Wheelahan Did Not Actually Betray or Harm the Settlement Class.

Notwithstanding the clearly threatening tone and content of the November 19 e-mails, Ms. Wheelahan denies that

she intended the e-mails to convey any threat to undermine the settlement. I discuss the issue of her intent in the

next section. As a threshold matter, regardless of her testimony about her intent, I sought to determine whether

or not Ms. Wheelahan ever actually engaged in any conduct to undermine the settlement, whether pursuant to

the plan outlined in the November 19 e-mails or otherwise. If Ms. Wheelahan had taken any step to implement

such a scheme—i.e., to plant a limitations or other issue in a motion to dismiss the appeal, designed to scuttle

the approved settlement so that she could cut a deal with Trans Union in Louisiana that would pay her more and

class members less—there is no question she would thereby have earned a severe sanction and a referral to the

Executive Committee for additional “discipline.” The duty of loyalty to a client is perhaps the most basic duty

of a lawyer, especially of one appointed counsel for a certified settlement class. Among the applicable ethical

rules such conduct would implicate are Rule 1.1(a) (duty of competent representation); Rule 1.2(a) (duty to abide

by client's decision whether to accept an offer to settle a matter); Rule 1.7(a)-(b) (regarding conflicts of interest

between clients and between lawyer and client, here conflicting interests among the Louisiana state court class,

the national MDL class and Ms. Wheelahan herself); Rule 1.8(b) (regarding conflicts of interest and prohibited

transactions, here the use of information regarding the statute of limitations to the disadvantage of a client);

Rule 8.4(a) (4) (conduct involving dishonesty, fraud, deceit or misrepresentation, here the appearance of acting

on behalf of the Settlement Class in the course of filing a motion planting a time bomb calculated to blow up

the settlement). 41 However, for several reasons, I am convinced that Ms. Wheelahan did not actually attempt

to overturn the Settlement. She remained loyal to the Settlement Class. Despite the November 19 e-mails, the

Settlement Class was never in any genuine danger of betrayal.

41 I cite to the Rules via the nomenclature of the ABA's Model Rules of Professional Conduct. The Rules applicable

here to Ms. Wheelahan are part of the Court's Local Rule 83.50.1 et seq. Thus, the actual cite, for example, to Rule

1.7 is Local Rule 83.51.7.

1. Ms. Wheelahan's denial is supported by the record and common sense.
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*30 The record and surrounding circumstances corroborate Ms. Wheelahan's categorical denial of taking any

step intended to harm or betray the class. None of the documents produced to me suggest that she took any step

to undermine the settlement, including during the time period from November 20 to April 6, when she had no

reason to think that the Court or anyone other than Texas Counsel had seen the e-mails. To the contrary, it appears

that, in fact, she opposed the objectors in the Court of Appeals and participated to some extent in the settlement

proceedings in that Court with the goal of ending the appeal and preserving the settlement.

I also conclude that the class was never in danger because the scenario Ms. Wheelahan spun out to Mr. Toups

made no sense. What she proposed there could not have been pulled off, and Ms. Wheelahan is more than smart

enough to have understood that.

First, it is unlikely that the Seventh Circuit would “reject the settlement” based on a motion to dismiss the appeal.

Such a motion, if successful, would lead to dismissal of the appeal, not rejection of the settlement. (Ms. Wheelahan

testified that the “motion to dismiss” phrase was nonsensical and a mistake; that is discussed further below.)

Although it is not unheard of for the Seventh Circuit to opine on issues not presented by the parties, particularly

jurisdictional issues, it is almost inconceivable here that it would have vacated a settlement—resolving a nearly

decade-old MDL matter—on limitations grounds that had been knowingly waived by Trans Union and that were

not pressed by the objectors. Indeed, a fundamental premise of the “threat scenario” in the November 19 e-mails

was incorrect: that the Seventh Circuit might decide sua sponte that the statute of limitations was a jurisdictional

impediment to the settlement that could not be waived. Although to my knowledge the Seventh Circuit had not

addressed this issue in the context of FCRA, it has emphatically declared that federal statutes of limitation are

generally non-jurisdictional; private parties may waive them. In Lawyers Title Ins. Corp. v. Dearborn Title Corp.,

118 F.3d 1157, 1165–67 (7th Cir.1997) (Posner, J.), the Seventh Circuit held that the one-year statute of limitations

of the Real Estate Settlement Procedures Act (“RESPA”), 12 U.S.C. § 2601, is non-jurisdictional and waivable.

In so ruling, the Court wrote: “we cannot find any case that holds a federal statute of limitations jurisdictional on

this ground. With one exception to be noted, courts hold federal statutes of limitations to be jurisdictional only

when the United States is a defendant-that is, out of regard for the defendant (and in keeping with the general

reluctance of courts to estop the government to assert its statutory rights) rather than out of regard for the courts or

for the social interest in burying old claims.” Id. at 1166. The Seventh Circuit also observed that federal statutes of

limitations are “universally regarded as nonjurisdictional,” including the limitations period of the Truth in Lending

Act, and it declined to follow the “one exception,” a D.C. Circuit TILA case going against the “universal” rule.

Id. Hence, while RESPA and TILA are not FCRA, the likelihood was virtually nil that the Seventh Circuit would

sua sponte issue a decision finding FCRA not subject to the “universal” rule. 42 The FCRA statute of limitations

is waivable and presented no jurisdictional risk in the appeal. If the e-mails were threatening sabotage by raising

a limitations question (which Ms. Wheelahan denies), the threat was empty.

42 I also asked plaintiffs' counsel to provide me any authority of which they were aware holding that the FCRA statute

of limitations is jurisdictional. None was provided.

*31 Second, it is speculative and highly doubtful that Trans Union would have agreed to the sweetheart deal

imagined in the e-mail or that Ms. Wheelahan could have secured the large fee based on it. Ms. Wheelahan and Mr.

Toups testified, and I have no doubt, that Trans Union was represented by excellent lawyers. The Settlement they

negotiated contains a statute of limitations waiver. They certainly knew what their client was waiving, and what

the applicable limitations law is. If the limitations period here were jurisdictional and if Trans Union could have

defeated much of this lawsuit on that ground and secured a more favorable resolution in Louisiana, its sophisticated

counsel would have pursued that path before agreeing to settle the MDL matter for over $100 million in cash and

in-kind benefits. Any notion that Ms. Wheelahan had a silver bullet unbeknownst to Trans Union was fantasy.

And Trans Union in fact worked to settle the appeals with the objectors rather than take any risk of the settlement

being overturned. It clearly believed the settlement was in its best interest, better than cutting some sweetheart
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deal in Louisiana. Finally, there may have been no sweetheart deal to cut. When Ms. Wheelahan wrote the e-mail

she probably had forgotten that the Court had stated that she had waived a fee recovery in Andrews in connection

with persuading the Court to remand that case to Louisiana. See n. 22 above. But Trans Union would not have

forgotten that arguable waiver, and so the prospect of a better fee recovery in Andrews was doubtful.

Third, notwithstanding what the November 19 e-mails say, it was plainly not in Ms. Wheelahan's interest—it was

not really “better” for her—to seek to undermine the MDL settlement. Her ultimate share of the $109 million

MDL settlement, if upheld on appeal, even the $4.5 million fee then apparently on the negotiating table (or, as

it turns out, the much lower fee I recommend above), was more valuable than gambling on derailing the MDL

settlement to land a better fee (even if one had not been disclaimed) from a speculative Louisiana settlement.

Finally, there is no plausible way in which Ms. Wheelahan could actually have succeeded in betraying the class.

Any attempt to have done so would have been bizarre and subject to an immediate coordinated attack from at

least some of her co-counsel, and probably from Trans Union as well. Texas Counsel had already taken a step

in that direction by giving the e-mails to the Magistrate Judge. The prospect of a lawyer betraying the class she

represented would have ensured that the betrayal would quickly flame out. Accordingly, I conclude that there was

neither actual harm nor realistic threat of harm to the settlement class occasioned by the sending of the e-mails or

Ms. Wheelahan's subsequent conduct relating to the threat in the e-mails.

2. Texas Counsel's theory that Ms. Wheelahan actually tried to undermine the settlement is implausible

and unsupported.

*32 As noted, if Ms. Wheelahan had done anything to try to undermine the settlement, it is unlikely that other

counsel would not have found out about it and immediately taken action to squelch it. To confirm that she had

not done so, I specifically directed Plaintiffs' Counsel (after reminding them of their duties to the Settlement

Class and the Court) to advise me if they “know or have reason to suspect that the drafting or transmission of the

Wheelahan November 19–20, 2008 emails caused any harm to the settlement class, or that Ms. Wheelahan ever

took any affirmative step to undermine the approved MDL settlement in order to pursue a separate settlement in

the Louisiana lawsuit?” July 30, 2009 Memo from Special Master to Counsel. I also asked them to produce any

documents relating to this question. No counsel other than Texas Counsel claimed there was any such evidence.

The single fact identified by Texas Counsel in its written response was, in my judgment, irrelevant and nonresponsive. (It was Ms. Wheelahan's recent purported refusal to dismiss the Louisiana lawsuit that prompted a

motion by Trans Union's counsel (Doc. 641) that was later withdrawn. (Doc. 647.))

However, Mr. Toups contended during my examination of him that he had recently concluded that Ms. Wheelahan

did, in fact, try to undermine the settlement in a manner outlined in the November 19 e-mails. Toups Tr. at 53–

57. He claimed she did so in a motion to dismiss the appeal, which she ultimately filed on June 15, 2009, nearly

seven months after sending the November e-mails, two months after this Court rebuked her for sending the emails, and four days after my appointment as Special Master. When Ms. Wheelahan filed the motion, the appeal

had been stalled in mediation for several months under the auspices of the Seventh Circuit's mediation program.

Mr. Toups identified the following paragraph from page 2 of Ms. Wheelahan's motion to dismiss as a “Trojan

Horse” through which he believes she was providing the Seventh Circuit ammunition to overturn the settlement

on jurisdictional grounds:

The conduct that is the subject of all of the actions in the MDL ceased in 2001 pursuant

to an injunction imposed after the Federal Trade Commission's successful enforcement

action. Other than the claims of the certified Louisiana Andrews class that are included

in the settlement, no state law claims have been asserted based on the conduct that is the

subject of the MDL actions, after the district court's dismissal of state law claims in July,

2004. Objectors have not appealed that order.
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Motion to Dismiss Appeals (Examination Exhibit 21) at 2 (internal citations omitted). I am unpersuaded that

this paragraph was written to initiate the demise of the settlement, or could have done so. While a reader of the

statement might infer that newer state law claims might be untimely (if one knew the applicable state limitations

period), I believe the point of the paragraph, like other statements in the brief, is to make the factual and equitable

point that the settlement is good for the class and for the objectors. Later in the motion, Ms. Wheelahan refers

to the fact that the settlement does not release individual claims and extends the limitations period to bring such

claims. See id. at 4. Part of her argument for dismissal was that the appeals were moot since the objectors' rights

to bring individual claims would not be improved by overturning the settlement; they could only be harmed by

overturning the settlement. The limitations waiver in the settlement was germane to that argument. And, as noted

earlier, the law is quite clear that the FCRA statute of limitations is non-jurisdictional. Thus, although one could

question the legal strategy of filing the motion to dismiss during the midst of a mediation, I detect no whiff of foul

play in this filing. Indeed, the possibility that Ms. Wheelahan would try to undermine the settlement in June 2009,

after the Court had publicly aired the November 19 e-mails and appointed a Special Master to investigate the

matter, is remote. Ms. Wheelahan may sometimes march to the beat of her own drummer, but she is not suicidal,

as Mr. Toups's argument implies.

*33 Although I found Mr. Toups's theory improbable and born, at least in part, from deep mistrust of Ms.

Wheelahan arising from the deterioration of their working relationship, I found his belief in it sincere and I took it

seriously, particularly because he has much greater familiarity than I with the case and with Ms. Wheelahan. Thus,

in addition to questioning Mr. Toups on the subject, I questioned his co-counsel Mr. Fein, Trans Union counsel

Mr. O'Neil, and MDL Counsel Mr. Borderud. I also requested on short notice and received promptly from counsel

documents (principally e-mails) concerning Ms. Wheelahan's filing of the motion to dismiss and its impact, if any,

on the settlement of the appeals. The additional testimony and documents do not support Mr. Toups's conclusion,

and do not suggest to me that Ms. Wheelahan tried to undermine the settlement.

Mr. Toups says that Mr. Fein had reported to him a conversation he had with Trans Union counsel, Mr. O'Neil,

about whether Ms. Wheelahan's motion to dismiss was detrimental to the settlement. Both Mr. Fein and Mr. O'Neil

confirmed that they spoke in August 2009, after the settlement of the appeal had concluded. Mr. O'Neil called

Mr. Fein, probably in connection with the motion he was then preparing concerning Ms. Wheelahan having not

agreed to dismiss the Louisiana lawsuit on terms satisfactory to Trans Union. Mr. Fein recalls Mr. O'Neil stating

that something in the motion to dismiss “might be geared towards getting the 7th Circuit to take a closer look

at the case and maybe dismiss the whole settlement,” and that was one reason they settled so quickly with the

objectors. Toups Tr. at 143. According to Mr. Fein's account, “[t]hey [Trans Union] were concerned that that

was Dawn's secret purpose and it was a risk.” Id. at 144. Up until the call, Mr. Fein had not suspected anything

nefarious about the motion to dismiss. “When I read her motion ... I took it for what it was, that she was trying

to get rid of the objectors.” Id. at 143.

Mr. O'Neil does not know whether Ms. Wheelahan had any specific intent to derail the settlement. He believed

that her filing of the motion to dismiss was a mistake, since it created the possibility that the Seventh Circuit

might set a briefing schedule and address the merits of the appeal, and he and plaintiffs' counsel wanted to avoid

any risk of the settlement being overturned. He thought the filing placed the settlement at risk because it recited

facts concerning the merits of the settlement, creating the possibility that the Seventh Circuit might be tempted

to address the merits and perhaps render an unfavorable ruling. To avoid any such risk, even a small one, he,

MDL Counsel and Texas Counsel worked together to finalize quickly a settlement with the objectors that mooted

the appeals. (Ms. Wheelahan did not participate in the final phase of the settlement process, although she had

participated in earlier phases.) After the settlement was finalized, Mr. O'Neil was looking anew at the November

19 e-mails and suspected that perhaps the motion to dismiss, because it discussed matters other than the standing

issue raised in the motion, might have had a hidden agenda. Sept. 11, 2009 Tr. at 11–18.
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*34 Messrs. O'Neil and Borderud's recollections of their conversation were sketchy, and shed no additional

light. They agreed, however, that they shared a concern to avoid the unpredictability inherent in a review by the

Seventh Circuit of the merits of the appeal. 9/11/09 Tr. at 14. None of MDL Counsel stated that they believed Ms.

Wheelahan had a specific intent to undermine the settlement. Rather, they believe that she viewed the Louisiana

case as a backup if the settlement should fall apart, but would not go so far as to claim that she tried to make that

happen through the motion to dismiss or otherwise. 9/11/09 Tr. at 23–25.

For her part, Ms. Wheelahan explained her strategy in an e-mail to her fellow Louisiana Counsel the day she filed

the motion to dismiss, and in other e-mails: she filed the motion to dismiss because the mediation process had

languished for half a year. She believed Trans Union had no interest in accelerating the process because delay

deferred implementation of the settlement. She concluded that filing the motion to dismiss made sense because

(i) it might succeed, (ii) it carried no risk to the merits of the appeal, and (iii) the standing issue might pressure

the objectors to come to the table with a more reasonable demand. Document HHKC Trans Union 000296–297

(6/15/09 e-mail from Ms. Wheelahan to other Louisiana Counsel explaining her reasons for filing).

In the final analysis, I view the disagreement among counsel over the filing of the motion to dismiss as one of

strategy, not ethical propriety. One could argue that the collective judgment of Trans Union, MDL Counsel and

Texas counsel—that the motion to dismiss should not have been filed—was more sound (certainly it was more

conservative) than Ms. Wheelahan's, which was, as is her wont, to go it alone and file the motion. But I was

not appointed to second-guess strategy. What is important is that the disagreement here is a legitimate one over

strategy, and the evidence does not support the notion that Ms. Wheelahan had a hidden agenda to lose the appeal

and kill the settlement. 43 Counsel's relationship with Ms. Wheelahan (especially that of Texas Counsel) has so

deteriorated that little trust remains and her motives are usually viewed with suspicion and in the worst light.

That lack of trust appears to have led some counsel to suspect an unethical motive behind the filing of the motion

to dismiss. However, finding no significant evidence to support the suspicion, I respectfully disagree with Mr.

Toups's theory and conclude that Ms. Wheelahan did not file the motion to dismiss the appeal as a subterfuge

to undermine the settlement.

43 Ironically, whatever one thinks of Ms. Wheelahan's strategy, it led to a result that all counsel wanted: a settlement

with the objectors and the dismissal of the appeal. While certain counsel may be unhappy with the particular terms

of the settlement (which are subject to a confidentiality provision and will not be discussed herein), it appears from

the e-mails produced to me that Ms. Wheelahan's motion did catalyze the remaining parties to come to terms quickly

and end the appeal.

E. Ms. Wheelahan's Intent

Having concluded that Ms. Wheelahan took no steps to harm the class, I turn to Ms. Wheelahan's intent. I find

credible her testimony that, notwithstanding what the November e-mails say, she never actually intended to betray

the class or undermine the approved settlement in the Seventh Circuit. Her success in defeating the prior proposed

settlements and helping to achieve the much greater final settlement was a significant professional achievement

she had every right to be proud of. “The supposition was never that I would do anything to overturn the settlement

that is frankly the pinnacle of my career. I am very proud of that settlement.” Wheelahan Tr. 48–49. I am persuaded

that Ms. Wheelahan never harbored any genuine intent to detonate the pinnacle she believed she had just climbed,

and, as discussed above, did not try to do so.

*35 But that does not end the analysis. While I have concluded that Ms. Wheelahan never intended or attempted to

betray the settlement class, the most natural reading of the November 19 e-mails is that she nevertheless threatened

to do so. This raises the question of whether it is sanctionable for a lawyer during a negotiation to threaten to

commit an illegal or unethical act as bargaining leverage.
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1. The e-mails were intended as threats.

Ms. Wheelahan denies the premise of this question. She testified that her e-mails were not intended as a threat

or bluff. Rather, she claimed that she was merely trying to communicate to Mr. Toups, albeit carelessly due to

the late hour and her anger, “the problems in his case.” Wheelahan Tr. 79. She also testified that the phrase in

the e-mails, “motion to dismiss,” was simply a careless mistake, and what she really meant to do was explain the

course of events that could ensue from a successful appeal by the objectors, not from anything she would insert

in a motion to dismiss.

For several reasons, I find that portion of her testimony strained and not credible. The e-mails read as a threat.

I see no innocent construction. And Ms. Wheelahan's testimony was not entirely consistent on this point. While

objecting to the term “threat,” she first denied and then acknowledged that there were elements of attempted “armtwisting” in the e-mails. Wheelahan Tr. 57–59, 72. I questioned her at length about her intent, and, while she did

not articulate it clearly, her explanation as to what she was trying to say to Mr. Toups, and why it supposedly was

not a threat to blow up the settlement, appears to be: (i) she wanted to keep a “food fight” among Plaintiffs' Counsel

out of the record because something said in a public fight might be seized upon by the objectors to overturn the

settlement; (ii) if the settlement were overturned on appeal, Texas counsel would lose the limitations protection of

the settlement (their suit was filed in 2006), but the certified Louisiana lawsuit would have no limitations problem;

and (iii) therefore, Texas Counsel should lower their fee demand because they have more to lose by not settling

and risking the public food fight that could give ammunition to the objectors. Thus, she described the e-mails

as merely a poorly worded and clumsy attempt to point out to Texas Counsel the problems and risks in their

negotiating position. Wheelahan Tr. 67–71.

This explanation is weak, because it does not square with the threatening language or tone of the e-mails (e.g., “the

better it looks”), and it does not make sense that a “public fight” over fees should have influenced Texas Counsel's

thinking about what fee to negotiate. Any public briefing about fees would be outside the appellate record and

irrelevant to the issue on appeal: the Court's decision, well before any public fee fight occurred, to approve the

settlement. Because the fee decision was independent of the issues on appeal, there would be no reason for Texas

counsel to base their negotiation position on the fate of the appeal. In contrast, the most natural reading of the emails—as a threat to sabotage the settlement in the appeal if Texas counsel did not lower its fee demand—does

logically link the fate of the appeal to Texas's negotiating position. In this reading, the “threat” makes some internal

logical sense because an intentional destruction of the settlement would result in a vacatur of any fee award.

*36 I also reject Ms. Wheelahan's position that the phrase “motion to dismiss” in the November 19 e-mail was

a mistake. If the November 19 e-mails were an aberration, a poorly drafted and not entirely coherent product

of anger and exhaustion, perhaps Ms. Wheelahan's “mistake” explanation might have some plausibility. But the

concept expressed in the e-mail had been germinating for some time before November 19 and similar threats were

conveyed or hinted at before and after November 19, during normal business hours and under less exhausting

circumstances.

On October 23, 2008, nearly a month before the November 19–20 mediation, Ms. Wheelahan and Mr. Caddell got

into an argument via e-mail over a $250,000 refund check from Hilsoft, the third-party involved in providing class

notice. Mr. Caddell had asked Hilsoft to send the money to his firm's client funds account and Ms. Wheelahan

thought the money should be sent to the Escrow Agent for the settlement. The exchange became personal and,

frankly, juvenile, and included some sniping over attorneys' fees and some threats. Ms. Wheelahan dismissed the

exchange as “two angry lawyers throwing threats at one another,” Wheelahan Tr. 93, and said they “were sent

back and forth between us in anger with the intention of annoying one another.” Id. at 99. Mr. Caddell bragged

that his firm had recovered a lot in fees during the past year, while needling Ms. Wheelahan for not having done

so. Having tweaked her financially, he said that “we are considering suggesting to Mason and Gettleman that we

wait until the settlement is complete [i.e., all claims finalized]
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Ms. Wheelahan took the bait, suggested that Texas Counsel had ulterior motives for delaying an attorneys' fee

award, and then followed up with an e-mail in the early afternoon:

And by the way, if the Settlement Agreement is not adhered to, we won't be asking the

Louisiana court to dismiss the certified Louisiana class—or perhaps the Louisiana court

will decide that the settlement does not release the Louisiana claims, or should not—and

then I do not believe there will be any attorney's fees coming from it, now or ever. It would

be a simple thing for me to tell [Trans Union counsel] Brian [Brooks] exactly how his client

is in a better position than they know, if the Settlement were overturned. And the judgment

of a district court without subject matter jurisdiction is worth exactly nothing.

Examinations Exhibit 5 (italics added). This e-mail alludes to the “jurisdiction” issue noted above and threatens

to “tell Brian” how Trans Union could be put in a better position if the settlement were overturned. The references

in this e-mail are oblique, and I do not believe any counsel at the time fully understood what she was implying or

took it seriously. None responded to the substance of this last e-mail. 44 This e-mail too was an empty threat, and

an unclear one as well. However, its significance is that the concept later expressed more clearly in the November

19 e-mails was in Ms. Wheelahan's mind several weeks earlier and foreshadowed in these e-mails.

44 Ms. Wheelahan did not realize at the time that defense counsel (although not Mr. Brooks) had been copied on and

were privy to the e-mail string. However, I do not believe that this oversight caused any harm because, as discussed

earlier, there was no genuine jurisdiction issue.

*37 And the concept remained in play after the November 19–20 mediation. On November 26, 2008 at 10:34

a.m., she sent an e-mail to John Zarian, one of the Frey counsel aligned with the MDL Counsel group. Following

the failure of the fee mediation, he was acting as a go-between to Toups and Texas Counsel, since they no longer

wanted to communicate directly with Ms. Wheelahan. She e-mailed him to offer ammunition for those discussions.

Her first paragraph of the November 26 e-mail said:

Hi, John. Thanks, again, for all your efforts. If it helps you at all to get Tx to come down

some-because I'm still not seeing why they're entitled to a multiplier over their lodestar,

when everyone else is taking a cut, and when they only submitted one pleading in the entire

case-I've attached the Order lifting the stay in our certified state law case. We remain willing

to seek fees there. And if the MDL settlement falls apart, bec the statute has run on the

claims, or for another reason, our state law case is ready to go forward, in a very favorable

court, as I explained to you.

Examination Exhibit 10 (italics added). Again, she linked the limitations issue to the MDL settlement “falling

apart,” followed by pursuing the Louisiana state case “in a very favorable court.” Similarly, in a December 1,

2008, 6:24 p.m. e-mail to her Louisiana co-counsel, Mr. Lane, she wrote about the status of Mr. Zarian's efforts

to negotiate with Mr. Toups. In relevant part, she wrote:

I told John [Zarian] that, since I'd be traveling, I thought Friday was my own deadline for

filing motions to dismiss the appeals in the 7th Cir. These are the same motions that would

raise the issue that the statute of limitations has run on all claims except ours and John

Zarian's. Mitch might be particularly concerned about this, bec he lost something in the

LA 4th Cir on just this issue ....
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Examination Exhibit 11 (italics added). Finally, in a December 5, 2008 e-mail, at 10:21 a.m., Ms. Wheelahan wrote

directly to Mr. Toups about the apparent collapse of the fee negotiations. The third and fourth paragraphs said:

And I also think there is a serious chance the 7th Cir. might find a statute problem with all the cases and

class statutory damages claims filed after September, 2004, when those were arguably abandoned by the MDL

counsel after the Sept 2002 ruling. I think the tolling provision in the settlement might be the only thing keeping

those claims alive, but the court had no jurisdiction to enter a judgment approving the settlement if the statute

had run and the claims were moot before it did. LA's certified unjust enrichment claims, and John Zarian's CA

state claims, might be all that's left. Which is not what I stayed in Chicago to see happen.

John said you've worked hard to bring your group along. We're just about ready to take another road, but hope

you can make some progress with them today. Let me know if I can help.

Examination Exhibit 13.

*38 These e-mails establish that the November 19 e-mails were not a mere aberration fueled by anger, wine

and exhaustion. Neither was the use of the phrase “motion to dismiss” an accident, since she had been drafting

such a motion and thought it might mention the limitations issue. As a general matter, Ms. Wheelahan considered

the certified Louisiana lawsuit to be an ace in the hole. It was a fallback for her if the MDL settlement should

fall apart (through legitimate process and without her assistance). She also considered it a possible avenue to

obtain a separate fee award through a legitimate process involving prior approval of the MDL court. 45 And, as

evidenced by the series of e-mails listed above, she tried to use the pendency of the Louisiana lawsuit as leverage

to try to persuade Texas Counsel to lower their fee demand, with the threat that a motion to dismiss might cause

several dominoes to fall, the last being a rejection of the settlement on limitations/jurisdictional grounds by the

Seventh Circuit. Ms. Wheelahan's current characterization of the e-mails as not conveying a threat to undermine

the settlement is, under all of the circumstances, unconvincing.

45 Ms. Wheelahan sent several e-mails to her colleagues, and also suggested to the Magistrate Judge during settlement

talks, that perhaps the parties and the Court would agree to entry of a lower fee judgment in the MDL Action and

permit her to seek additional fees in Louisiana in the Andrews Action, so long as the total fees awarded did not exceed

the $18.75 million cap in the settlement. The Magistrate Judge immediately rejected the concept and no other counsel

showed any support for it. This concept, while it had no genuine chance at being approved, presents no ethical issue.

2. Ms. Wheelahan acted alone in making the threat.

It should be noted that none of plaintiffs' other counsel were party to or, in most cases privy to, the threats.

Specifically, Mr. Zarian and Mr. Toups agree that Mr. Zarian did not convey to Mr. Toups any of the “ammunition”

Ms. Wheelahan had tried to feed him. Mr. Zarian was neither aware of the November 19 e-mails nor of any

intent by Ms. Wheelahan to threaten to undermine the settlement to gain a negotiating advantage. He largely

ignored her suggestions, sometimes because he didn't understand them and sometimes because he thought them

meritless, and his settlement communications with Mr. Toups were focused on numbers. I do not believe he or

other MDL Counsel were privy to or supported the concept of threatening to undermine the settlement. Likewise,

Ms. Wheelahan's Louisiana co-counsel, Mr. Lane and others at his firm, were unaware of the November 19 emails. While they were privy to some communications with Ms. Wheelahan regarding a possible motion to dismiss

the appeals, the limitations issue and the negotiations with Texas counsel, I do not believe that they were aware

of or supportive of any clear threat by Ms. Wheelahan to scuttle the settlement.

3. The threats do not warrant a sanction.
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Having rejected Ms. Wheelahan's argument that the e-mails were not intended as a threat to undermine the

settlement, I turn, finally, to whether the threats in the November 19 e-mails are sanctionable. My conclusion that

they are not should not be viewed as condoning Ms. Wheelahan's conduct. I have never seen anything quite like the

e-mails. The notion that a lawyer would even threaten to betray a client, let alone a class, is indeed “reprehensible,”

and strays far beyond conduct becoming of an attorney. However unseemly the conduct, I conclude that it did not

violate any specific rule of professional conduct or fiduciary duty. It was disrespectful of Texas Counsel, but not

directly contemptuous of the Court. 46 Accordingly, I recommend no sanction.

46 I note that in certain other e-mails produced to me by counsel, Ms. Wheelahan sometimes used sharp and disrespectful

language to certain describe rulings or statements by this Court or the Magistrate Judge with which she disagreed.

Some of the statements were intemperate, but I do not believe they violated Local Rule 83.58.2(a).

*39 The applicable Rules of Professional Conduct deal extensively with a lawyer's duties to her client and her

conduct before a tribunal, but they say little about her conduct with other counsel in the context of a negotiation.

There is little question that the Rules and legal culture tolerate and expect less decorum when lawyers bargain in

private than when they battle in public. In the hurly-burly of negotiation, depending on the style of the lawyer, it

is not uncommon to encounter posturing, brinkmanship, bluster, puffing, bluffing, braggadocio, and some sharp

elbows. Styles differ. Some lawyers are quiet persuaders and others are yellers. All lawyers in negotiations make

what might be called “threats,” to the extent that it is common to point out to the other side the consequences of

not agreeing. Many such “threats” cross no ethical boundary, such as a promise to take legal action (“settle for

our demand or we'll sue”) or assert a legal or factual position in a case (“settle or we'll depose your client and seek

summary judgment”). Certain other threats are clearly sanctionable, such as a threat to seek criminal prosecution

or disciplinary action (see Rule 1.2(e)) or a threat that would itself constitute criminal extortion. See State v. Hynes,

No.2008–371, 2009 WL 2382550 (N.H. Aug.5, 2009) (affirming conviction of lawyer under New Hampshire

extortion statute for obtaining $500 settlement from store owner by threatening a suit he had no right to bring

because, inter alia, he had no client); 720 ILCS 5/12–6 (Illinois crime of “intimidation,” defined as including, inter

alia, threats without lawful authority to inflict physical injury or to defame); Ethical Guidelines for Settlement

Negotiations, American Bar Association (August 2002), Section 4.3.2 (available at http:// www.abanet.org/

litigation/ethics/settlementnegotiations.pdf) (last visited Sept. 24, 2009) (listing as unethical threats that would be

extortion or defamatory); but see In re Finkelstein, 901 F.2d 1560 (11th Cir.1990) (reversing suspension of civil

rights lawyer for writing a letter threatening his opponent in a race discrimination case with a product boycott and

embarrassing publicity campaign if a settlement were not reached); United States v. Pendergraft, 297 F.3d 1198,

1205 (11th Cir.2002) (threats to file a lawsuit based on a false affidavit do not violate the Hobbs Act).

Here, Ms. Wheelahan's threat fell somewhere between these poles. I have construed the e-mails as a threat, made

to attempt to gain a negotiating advantage over co-counsel to the class, to assert a non-frivolous legal proposition

in a case for an improper, veiled motive—to betray the class they both represented. At first blush, one might

think the threat implicates Rule 1.2(f)(1), which provides that “[i]n representation of a client, a lawyer shall not ...

assert a position ... or take other action on behalf of the client when the lawyer knows or reasonably should know

that such action would serve merely to harass or maliciously injure another.” However, the threat here was not

made “on behalf of the client,” and the action would not “serve merely to harass or maliciously injure another.”

Similarly, without any action to carry out the threat, I do not believe that the conflict of interest rules, Rules 1.7

or 1.8, were violated.

*40 While a lawyer would not necessarily have to commit criminal extortion to be subject to a civil sanction

or discipline for making a threat, extortion cases discussing threats to pursue litigation shed some light on the

analysis. Most cases considering the issue hold that threats to sue or file legal papers, even if made in bad faith, do

not constitute criminal extortion. See, e.g., Pendergraft, 297 F.3d at 1205 (collecting cases). Threatening to file

court papers is not considered “wrongful” under the Hobbs Act because courts do not want to discourage parties
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from using courts to resolve disputes, and civil remedies (such as malicious prosecution or Rule 11 sanctions) are

considered sufficient to police abuses. Id. at 1206–07.

The recent Hynes case did affirm a conviction of a lawyer for sending extortionate demand letters, but the conduct

there differs as well from that of Ms. Wheelahan. Hynes's letters threatened to sue hair salons for discriminatory

pricing (for men, women's and children's haircuts) if he was not paid $1,000 to settle. Hynes had neither a

client nor any standing to sue individually. One hair salon agreed to pay him $500 to avoid the threatened

suit. He was convicted under the New Hampshire theft-by-extortion statute, which provides in relevant part that

extortion includes a threat to do any “act which could not in itself substantially benefit him but which would harm

substantially any other person with respect to that person's ... business.” Hynes, 159 N.H. 187, 978 A.2d 264, 2009

WL 2382550, at *2. Hynes had no claim of right to the proceeds or to use the means threatened to procure them.

In contrast, as noted, Ms. Wheelahan did have a claim of right to the moneys she was demanding (a higher share

of the fee allocation), and the threatened means were in part legitimate (filing a motion to dismiss the appeal).

In sum, the e-mails do not constitute criminal extortion, and, while they have an extortionate flavor, I found no

authority suggesting that they are sanctionable as a civil matter. Texas Counsel took it upon themselves to cite

a few authorities, which they suggest support the proposition that a threat to breach a fiduciary duty is itself

sanctionable. Two of the authorities do indicate that a noncriminal threat itself can be unethical, although in each

case the threat was acted upon. More importantly, however, in each case the threat was made directly to the client,

to whom the lawyer owed the fiduciary duties, not to a sophisticated co-counsel in an arms-length negotiation. In

that context, the threat itself was an act of direct disloyalty to the client. See In re Whitney Dove Hardy, Comm.

No. 03 SH 104 (Ill. ARDC Oct. 27, 2005) (available at http://www.iardc.org/03SH0104RB.HTML) (last visited

Sept. 24, 2009) (lawyer threatened client that he would (and later did) reveal confidential information damaging

to client's case if client did not pay fee balance); Sessions & Co., P.S. v. Carlson, 119 Wash.App. 1066, 2003

WL 23019953, at *3 (Dec. 29, 2003) (unpublished opinion) (lawyer threatened client that he would, without

withdrawing, cease work for the client, to the client's detriment, if unpaid bill were not paid). As discussed further

below, the fact that the recipient of the threat here was not the client, the opponent or a third party, but rather a

sophisticated attorney, who was co-counsel to the same class, is an important factor cutting against a conclusion

that the threat should be sanctioned.

*41 Apart from the question of extortion, one might contend that the e-mails were deceptive, and, therefore,

potentially sanctionable under Rule 4.1(1) (lawyer “shall not knowingly ... make a false statement of material

fact to a third person”) or Rule 8.4(a)(4) (a “lawyer shall not ... engage in conduct involving dishonesty, fraud,

deceit or misrepresentation”). Because Rule 8.4(a)(4) does not prohibit conduct that is permissible under Rule 4.1,

see ABA Formal Op. 06–439, Lawyer's Obligation of Truthfulness When Representing a Client in Negotiation:

Application to Caucused Mediation, at 5 n. 2 (April 12, 2006), I focus on Rule 4.1.

The Rule 4.1 argument would be that, as I've construed them, the e-mails were a deceptive bluff. Ms. Wheelahan

made a threat to do something improper that she had no genuine intent to carry out. But the proscriptions of Rule

4.1 apply to statements of fact. The Committee Comments to the Rule state:

Whether a particular statement should be regarded as one of fact can depend on the

circumstances. Under generally accepted conventions in negotiation, certain types of

statements ordinarily are not taken as statements of material fact. Estimates of price or value

placed on the subject of a transaction and a party's intentions as to an acceptable settlement

of a claim are in this category, and so is the existence of an undisclosed principal except

where nondisclosure of the principal would constitute fraud.

This comment defines away, as a matter of formal professional ethics, much of the feinting that occurs in some

negotiations. In this case, the statement or promise at issue is about future conduct, not historical fact. Such
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future-oriented statements are typically not considered “factual” under fraud case law. See, e.g., Continental

Bank, N.A. v. Meyer, 10 F.3d 1293, 1298 (7th Cir.1993) (“A statement ... which relates to future or contingent

events, expectations or probabilities, rather than to pre-existent or present facts, ordinarily does not constitute an

actionable misrepresentation under Illinois law.”) (internal quotations omitted); Restatement (Second) of the Law,

Contracts, § 159 cmt. c (“facts” include past events or present circumstances, but not future events unless there is

an implication of false present or past fact). Thus, while an attorney can be disciplined for lying in a negotiation

about an objective material fact, such as the amount of available insurance coverage or the death of the client, see

ABA Formal Op. 06–439 at 3, 47 a threat to take particular legal action is a statement about the future and is not

generally received as a hard promise, but rather as something the speaker “might” do.

47 Other examples of misrepresentations of fact in a negotiation include lying about how much a particular term will cost

a party or falsely claiming that certain documentary evidence exists. Formal Op. 06–439 at 1.

Context is everything:

Whether a statement should be so characterized [as one of fact] depends on whether the

person to whom the statement is addressed would reasonably regard the statement as one

of fact or based on the speaker's knowledge of facts reasonably implied by the statement, or

instead regard it as merely an expression of the speaker's state of mind. Assessment depends

on the circumstances in which the statement is made, including the past relationship of the

negotiating persons, their apparent sophistication, the plausibility of the statement on its

face, the phrasing of the statement, related communication between the persons involved,

the known negotiating practices of the community in which both are negotiating, and similar

circumstances.”

*42 Restatement (Third) of The Law Governing Lawyers, § 98, cmt. c (2000). These factors, particularly

consideration of the audience receiving the threats, cut strongly in favor of construing the threats as non-factual.

• “Past relationship” and “apparent sophistication.” Ms. Wheelahan did not threaten a stranger, the opponent

to her client, her client, or a vulnerable non-lawyer. She had worked with Mr. Toups on previous matters and

was still his co-counsel in this case. He is a very experienced and sophisticated lawyer. He impressed me as

someone who would not be intimidated or snookered easily.

• “Plausibility” and “phrasing of the statement.” As discussed earlier, the statement was hardly “plausible on

its face” and its phrasing was not a model of clarity. Indeed, the “threat,” such as it was, baffled Mr. Toups

at the time. He testified that he understood the gist as a threat to betray the class, but could not figure out

what Ms. Wheelahan was planning or how she could pull it off. He only later came to understand the internal

logic of the threat after this investigation began and documents were produced. Toups Tr. 45–46. On the

morning he received the threat, he and his co-counsel Mr. Fein exchanged e-mails in which Mr. Fein opined

that he thought “she's just making nonsensical threats.” Examination Exhibit 20. Mr. Toups testified that he

did not concur with that assessment, but he also did not understand at the time how she could carry out the

threat. Toups Tr. 81–87.

• “Related communication between the persons involved.” As noted above, Ms. Wheelahan sent other e-mails

that had other threats, or unorthodox suggestions, such as the suggestion that the MDL Court might agree

to enter a lower fee judgment while granting Louisiana Counsel permission to seek additional fees from

the Louisiana Court. The paper record reveals that no counsel specifically responded to these suggestions,

and none agreed to them. Mr. Toups himself did not respond to her December 5 e-mail that again raised

the limitations issue. See above at 59–60. In general, it appears that Plaintiffs' Counsel generally let Ms.

Wheelahan blow off steam from time to time and ignored her more unusual statements or unorthodox

procedural ideas.
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• “Known negotiation practices in the community.” I cannot comment on negotiation practices in Louisiana

or Texas, but doubt that the culture diverges greatly from that in Chicago in this context. In my experience,

most lawyers take with a grain of salt statements by adversaries about what they might do in the future in a

lawsuit, and do not consider them in the same light as a representation of objective fact.

These considerations lead to the conclusion that, while the threat was imbued with an element of deception, it

was not a dishonest misrepresentation of “fact” as meant in the ethical Rules. Making outrageous or misleading

statements about future conduct (bluffing) might ultimately damage a lawyer's credibility or poison a relationship

with a colleague or opposing counsel. Doing so would be eschewed by many lawyers as “reprehensible” and

contrary to their personal ethics and standards for the appropriate practice of law. But they are not per se a violation

of the applicable Rules of Professional Conduct, and were not so in this factual situation.

*43 Accordingly, I concur with Mr. Fein's initial impression of the e-mails the morning after they were sent.

They were “nonsensical threats.” They had no real bite. They did not influence Texas Counsel. They caused no

harm to the class. They were not acted upon. They were not “prejudicial to the administration of justice.” Rule

8.4(a)(5). 48 In light of all of these circumstances, including the fact that there is no rule or clear legal authority

specifically addressing this situation, cf. Finkelstein, 901 F.2d at 1565 (reversing suspension of lawyer because

there was no clear authority prohibiting overreaching threats he made to his opponent), I do not recommend that

the Court sanction Ms. Wheelahan for what was, at the end of the day, outrageous “nonsense” spouted to her

co-counsel. And, for what it is worth, I also believe that this investigation in and of itself, as well the criticisms

expressed above, has already exacted a substantial de facto toll on Ms. Wheelahan.

48 The e-mails might have hastened the demise of the fee mediation, but it seems clear that it was heading for impasse

in any event.

One last loose end: Texas Counsel cite authority holding that a lawyer who breaches a fiduciary duty to a client

might be subject to a full or partial forfeiture of fees. 49 Burrow v. Arce, 997 S.W.2d 229, 238–245 (Tex.1999).

There is indeed authority, in Illinois and elsewhere, sometimes referred to as the “disloyal servant” doctrine,

stating that an agent or other fiduciary can forfeit compensation earned during the period of a willful breach of

duty. See, e.g., Clinton Imperial China, Inc. v. Lippert Marketing, Ltd., 377 Ill.App.3d 474, 481–82, 316 Ill.Dec.

8, 878 N.E.2d 730, 737 (1st Dist.2007); Dowd & Dowd, Ltd. v. Gleason, 352 Ill.App.3d 365, 385, 287 Ill.Dec. 787,

816 N.E.2d 754, 771 (1st Dist.2004). This includes lawyers' breaches of fiduciary duties to clients. See generally

Restatement (Third) of the Law Governing Lawyers, § 37 (discussing when a forfeiture of “some or all” of a

lawyer's fee is warranted when there has been a “clear and serious violation of duty to a client”). This authority is

irrelevant here, since I have concluded that Ms. Wheelahan did not breach her fiduciary duty to a client. Further,

even if sending the e-mails were unethical, I do not believe a fee forfeiture would be an appropriate sanction

(as opposed to a lesser sanction such as a reprimand or her removal as class counsel), where she took no action

intended to betray the class by undermining the settlement. See Restatement, § 37 cmts. d & e (and cases cited in

Reporter's Note) (describing criteria informing whether any fee forfeiture is proper).

49 At the outset of my appointment, to avoid a feeding frenzy, I had informed Plaintiffs' Counsel that if the ethical issues

resulted in any recommended reduction of fees, the reduction would inure to the benefit of the class, not other counsel.

Texas Counsel are aware of that, and I believe they did not cite this authority to benefit themselves financially.

IV. OTHER ETHICAL ISSUES—BILLING PRACTICES

I now turn to the remaining issues to which the Court referred in the April 6 Order.

A. Charges for Travel
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When Louisiana Counsel and Counsel other than Texas Counsel filed their joint fee petition, they sought fees

under the percentage method. However, as discussed above, they also made summary claims as to their lodestars

in an effort to justify the percentage they were seeking. Ms. Wheelahan also submitted detailed hourly billing

records in support of her claimed lodestar. In its April 6 Order, the Court criticized some of the categories of time,

most notably a list of nearly 400 hours of time “travel time in Chicago,” which it attached as Appendix A. These

were recorded in 12–hour increments, one 12–hour entry for each trip to Chicago, regardless of how many days

she spent in Chicago for any trip. These charges were in addition to any charges for time actually spent in transit

or on work for this matter. Thus, for example, if Ms. Wheelahan spent six hours traveling to Chicago on Day 1

and six hours returning to New Orleans on Day 2, she would bill the twelve hours for the actual travel time to

and from Chicago, and would also add one flat twelve hour charge, on either Day 1 or Day 2, for travel time in

Chicago. If Ms. Wheelahan worked while traveling to or from Chicago, she did not “double bill” that time with

the travel time “to” or “from” Chicago, but the twelve hour flat charges were entered regardless of the number of

hours she was actually working on any matter or in transit. Wheelahan Tr. 165. The consequence of this practice

is that there were travel days on which she billed close to, or even more than, 24 hours.

*44 Ethical rules mandate that “[a] lawyer's fee shall be reasonable.” Rule 1.5(a). See also Cripe v. Leiter, 184

Ill.2d 185, 198, 234 Ill.Dec. 488, 703 N.E.2d 100, 107 (1998) (“[T]he attorney's fiduciary position prohibits the

attorney from charging an excessive fee.”). These travel time charges are excessive and unreasonable. In general,

if a lawyer tried to charge such time to her fee-paying clients, she would quickly generate a roster of angry exclients. Indeed, Ms. Wheelahan testified that if she had fee-paying clients, she would ask for approval before

billing for travel as she did here. Wheelahan Tr. 171. Ms. Wheelahan should have treated the Court (which sits

as fiduciary for the class on this issue) in the same fashion by raising the issue. However, as explained below,

I do not believe a sanction is warranted for Ms. Wheelahan's failure to explicitly raise the issue or delete these

charges from her fee detail.

Ms. Wheelahan's law practice is almost entirely contingent and she generally does not bill fee paying clients for

travel or anything else. Even in the context of timekeeping for contingent matters, it was not Ms. Wheelahan's

regular practice to record travel time in this manner. She did so for the first time in this case, based on her reading

of two Seventh Circuit opinions, In re Maurice, 69 F.3d 830 (7th Cir.1995), and Henry v. Webermeier, 738 F.2d

188 (7th Cir.1984). Ms. Wheelahan explained that these twelve-hour charges were meant to compensate her for

the opportunity cost of travel—for time that she was out of her office in New Orleans and away from home. She

read Maurice and Henry to authorize her to bill “for the entire time, door-to-door, that the matter took her out of

her offices,” and implied that she is being generous to the class in only billing a flat twelve-hour fee (in addition

to actual travel and work time) even if her time away from New Orleans was much longer. See Mot. to Amend

Judgment (Doc. 597 at 22); Wheelahan Tr. 168–72.

Ms. Wheelahan ultimately acknowledged in her testimony that she misread Maurice and Henry, since the cases

“don't say that I can do that [i.e., bill portal-to-portal]. But they don't say that I can't do it either.” Wheelahan Tr.

172. The cases plainly do not support her practice. See Henry, 738 F.2d at 194 (dictum stating that “opportunity

cost is equal to the fee [lawyer] would have charged that or another client if he had not been traveling”); Maurice,

69 F.3d at 834 (stating that a “trip to Chicago that diverts time from other paying engagements” is compensable,

but not saying anything about a flat travel charge for time “in” Chicago).

Ms. Wheelahan misunderstood the concept of “opportunity cost” as discussed in those cases. If a lawyer has to be

on a plane or in another city on behalf of client, and away from her desk during time when she would otherwise be

billing clients, charging her client for the travel time for that client may be reasonable as a lost opportunity cost.

But the mere time spent in another city away from family or home, while a personal cost of travel, is not normally

a chargeable opportunity cost, unless it is “time [diverted] from other paying engagements,” Maurice, 69 F.3d at
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834, because, while at home, the lawyer doesn't bill a client for eating dinner with her family or sleeping. Ms.

Wheelahan's billing practice effectively charged time for sleeping in a hotel.

*45 Most clients would not tolerate such a practice, and it would be an easy decision for a court doing a formal

lodestar analysis to eliminate all such entries as unreasonable and excessive. However, the fact that the charges

were unreasonable does not make them per se sanctionable as a violation of professional ethics. First, in doing

lodestar analyses courts routinely delete charges that are labeled “unreasonable,” “excessive” or “duplicative.”

The mere fact that time entries are so labeled does not mean the lawyer submitting them has acted unethically.

Second, the practice, while based on a fundamental misunderstanding of the “opportunity cost” concept, is not

per se prohibited. In theory, an attorney who hated traveling and rarely took out-of-town representations and a

sophisticated client who strongly desired that attorney's representation in an out-of-town matter could agree to a

billing arrangement that included a travel premium, perhaps even in the form of an additional twelve-hour flat

fee per trip. It would be a sort of retainer. Third, Ms. Wheelahan did not act deceptively. While she did not raise

the issue, neither did she try to hide or disguise the charges. Although based on a poor reading of the law, they

appeared in plain view in her fee detail.

In my view, this is principally a Rule 11 issue. Maurice and Henry offer such flimsy support for Ms. Wheelahan's

interpretation that, if she did not violate it, she skated to the brink of Rule 11(b)(2) (legal contentions must be

warranted by existing law or by a non-frivolous argument for extending the law or establishing new law). The

Court has authority to impose Rule 11 sanctions on its own initiative, Fed.R.Civ.P. 11(c)(3), but any sanction must

be “limited to what suffices to deter repetition of the conduct or comparable conduct by others similarly situated.”

I believe the criticism of her position set forth herein already suffices to deter repetition by Ms. Wheelahan (who

has already admitted her reading of the cases was mistaken) or others. Thus, I do not think it necessary to decide

whether her reading was so strained that Rule 11(b)(2) was actually violated.

In the final analysis, then, I conclude that Ms. Wheelahan is guilty of very poor judgment, but not dishonest or

sanctionable misconduct. She should have realized that billing 25–hour days would appear grossly overreaching,

damage her credibility and anger the Court. She should not have included the time or at least should have explained

why it was there. Instead, I suspect that she recorded the time based on her misreading of the law and then forgot

about it when submitting her time records. That is, at best, sloppy practice. Nevertheless, because I found her

misreading of the law sincere and her conduct non-deceptive, I do not recommend that the Court sanction her.

B. Supreme Court Argument

The Court also criticized Ms. Wheelahan for including in her fee detail time spent traveling to Washington, D.C.

to attend a Supreme Court argument in a FCRA case that was not part of this MDL proceeding. April 6 Order

at 7. Ms. Wheelahan defends the entries as appropriate because the argument involved the key FCRA issue of

“wilfulness,” and Trans Union counsel traveled to attend the argument. To the extent this time was for travel time

“in” Washington, it presents the same issue discussed above. To the extent this time was for attendance at the

argument, the fact that Trans Union's counsel also attended the argument gave Ms. Wheelahan a good faith basis

to include the time, although again she should have anticipated that the time would raise a serious question as to

reasonableness and she should have explained why it was included. But her inclusion of the Supreme Court time

does not, in my view, warrant any sanction.

C. Other Items Flagged by the Court

*46 The Court referred to a few additional billing problems that, along with the preceding ones, caused it to

“lack[ ] all faith in the veracity of the hours billed,” April 6 Order at 8, not only of Ms. Wheelahan, but all Plaintiffs'

Counsel. These involved billing for clerical tasks, billing for unsuccessful tasks (such as MDL billing for the

unsuccessful first and second settlements or Louisiana Counsel billing for certain pleadings that were stricken),
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billing for duplicative work, and vague billing entries. Id. at 4–8. As with the preceding issue, I do not believe

these problems present any substantial question of sanctionable unethical conduct. Rather, the issues noted by the

Court are ones commonly encountered in lodestar litigation, and result in lodestar reductions. Because they were

seeking a recovery under the percentage method, it appears that all Counsel simply dumped their raw lodestars on

the Court (perhaps relying on cases, cited above, in which courts did cross-checks based on raw lodestars) and did

little or nothing in the way of any review to eliminate administrative, duplicative, inefficient, or unreasonable deadend time. In my rough lodestar cross-checks above, I accounted for such excesses in conservatively estimating

substantial cuts in the putative lodestars. Although Counsel's approach is not sanctionable, if Counsel wish to

present lodestar figures or data in support of a common fund percentage fee request, a better practice in the future

would be to review and reduce raw lodestars before presenting them to the Court, or to acknowledge to the Court

that the lodestar data is raw and unreviewed and attempt to defend that practice.

D. General Review of Billing Records

The June 11 Order appointing me as Special Master directed me to “examin[e] the time records of all counsel.”

The foregoing discussion makes evident that I requested and examined counsel's time records. Specifically, I

asked for (or already had) time records of Louisiana Counsel, Texas Counsel, Liaison Counsel, Frey Counsel,

Lead MDL Counsel and a representative sample of non-lead MDL Counsel firms. Because I ultimately decided to

do a lodestar cross-check rather than a full-blown lodestar analysis, I did not scrutinize every time entry. Rather, I

conducted enough of a review to make the rough estimates needed for the check. I also made spot-check reviews

of various time entries of Counsel to see whether there were billing irregularities other than those flagged by the

Court. I reviewed Louisiana Counsel's time entries in much greater detail. Having done so, I saw no other issues

of an ethical nature to report.

V. CONCLUSION

For the foregoing reasons, I recommend that the Court (i) order a fee award of $12.98 million including an

allocation of $7,836,683 to MDL Counsel, $2,722,360 to Louisiana Counsel, and $1,815,319 to Texas Counsel,

and (ii) impose no sanction on Ms. Wheelahan or other Plaintiffs' Counsel. I thank the Court for the opportunity

to be of assistance.

*47 Pursuant to the June 11, 2009 Order appointing me, a statement detailing the time and expenses of me and

my firm through September 30, 2009 is attached as Exhibit 1and is submitted for the Court's review and approval.

Please note that in the exercise of billing judgment, I reduced our raw time of $117,234.50 by $12,000 for a total

request of $105,234.50 in fees and $6,041.56 in expenses, for a total request (after dropping the cents) of $111,276.

The expenses were incurred principally to pay court reporters for my examinations of counsel and to transcribe

telephone conferences with counsel. Charges for hosting conference calls (including for the examinations) and

Westlaw research comprise most of the remainder.

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2012 WL 2340406 (F.T.C.)

Federal Trade Commission (F.T.C.)

In the Matter of POM WONDERFUL LLC and ROLL GLOBAL LLC, as successor in interest

to Roll International Corporation, companies, and STEWART A. RESNICK, LYNDA RAE

RESNICK, and MATTHEW TUPPER, individually and as officers of the companies, Respondents.

Docket No. 9344

May 17, 2012

PUBLIC

INITIAL DECISION

TABLE OF CONTENTS

I. INTRODUCTION........................................................................................................................ 1

A. Summary of Complaint and Answer............................................................................................ 1

B. Procedural History........................................................................................................................ 2

C. Evidence........................................................................................................................................ 3

D. Summary of Initial Decision........................................................................................................ 5

II. FINDINGS OF FACT................................................................................................................ 6

A. The Respondents........................................................................................................................... 6

1. POM Wonderful LLC................................................................................................................... 6

2. Respondent Roll Global LLC....................................................................................................... 7

3. Respondents Stewart and Lynda Resnick..................................................................................... 8

4. Respondent Matthew Tupper........................................................................................................ 10

B. The POM Products....................................................................................................................... 12

1. Description of the POM Products................................................................................................. 12

a. POM Juice..................................................................................................................................... 12

b. POMx Liquid................................................................................................................................. 13

c. POMx Pills.................................................................................................................................... 13

2. Safety of the POM Products......................................................................................................... 14

3. Sales of the POM Products........................................................................................................... 15
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C. Background Facts......................................................................................................................... 16

1. History of POM and science program.......................................................................................... 16

a. Overview........................................................................................................................................ 16

b. Early research................................................................................................................................ 17

c. Relevant studies............................................................................................................................. 18

2. Advertising process....................................................................................................................... 20

a. Overview........................................................................................................................................ 20

b. Development of advertising.......................................................................................................... 21

c. Creative briefs................................................................................................................................ 22

3. Target audience for POM Products advertising............................................................................ 24

D. Testifying Experts......................................................................................................................... 26

1. Complaint Counsel's experts......................................................................................................... 26

a. Dr. Meir Stampfer......................................................................................................................... 26

b. Dr. Frank Sacks............................................................................................................................. 28

c. Dr. James Eastham........................................................................................................................ 30

d. Dr. Arnold Melman....................................................................................................................... 31

2. Respondents' experts..................................................................................................................... 32

a. Dr. Denis Miller............................................................................................................................ 32

b. Dr. David Heber............................................................................................................................ 33

c. Dr. Dean Ornish............................................................................................................................ 34

d. Dr. Arthur Burnett......................................................................................................................... 35

e. Dr. Irwin Goldstein........................................................................................................................ 36

f. Dr. Jean deKernion........................................................................................................................ 37

g. Dr. Ronald Butters........................................................................................................................ 39

h. Dr. David Reibstein....................................................................................................................... 39

3. Complaint Counsel's rebuttal experts............................................................................................ 41

a. Dr. Michael Mazis......................................................................................................................... 41

b. Dr. David Stewart.......................................................................................................................... 42

E. Alleged Advertising Claims.......................................................................................................... 43
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1. Facial analysis............................................................................................................................... 43

a. Alleged “clinically proven” claims............................................................................................... 43

i. Print advertisements....................................................................................................................... 43

ii. Newsletters.................................................................................................................................... 51

(a) Heart Newsletter.......................................................................................................................... 52

(b) Prostate Newsletter...................................................................................................................... 53

iii. Website advertising...................................................................................................................... 53

(a) Website background facts............................................................................................................ 53

(b) Website claims............................................................................................................................. 55

(i) Pomwonderful.com....................................................................................................................... 55

(ii) Pompills.com............................................................................................................................... 58

(iii) Pomegranatetruth.com................................................................................................................ 63

iv. Press releases................................................................................................................................ 64

b. Alleged efficacy claims................................................................................................................. 67

2. Extrinsic evidence regarding advertisement interpretation........................................................... 71

a. Summary of expert opinions......................................................................................................... 71

i. Respondents' expert Dr. Butters..................................................................................................... 71

ii. Complaint Counsel's rebuttal expert Dr. Stewart......................................................................... 75

b. Findings of fact regarding advertising interpretation, based upon testimony of Dr. Butters and

Dr. Stewart.........................................................................................................................................

76

c. Bovitz Billboard Survey................................................................................................................ 78

3. Television interviews..................................................................................................................... 83

4. Summary of findings on advertising claims................................................................................. 84

F. Level of Required Substantiation................................................................................................. 87

1. Types of studies............................................................................................................................ 87

a. In vitro studies............................................................................................................................... 87

b. Animal studies............................................................................................................................... 88

c. Human observational studies......................................................................................................... 88

d. Human clinical studies.................................................................................................................. 89

2. Randomized clinical trials............................................................................................................. 90
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3. Testimony from Complaint Counsel's experts on whether RCTs are required............................. 93

a. Dr. Meir Stampfer......................................................................................................................... 93

b. Dr. Frank Sacks............................................................................................................................. 95

c. Dr. James Eastham........................................................................................................................ 96

d. Dr. Arnold Melman....................................................................................................................... 97

4. Testimony from Respondents' experts on whether RCTs are required......................................... 98

a. Dr. Denis Miller............................................................................................................................ 98

b. Dr. David Heber............................................................................................................................ 99

c. Dr. Dean Ornish............................................................................................................................ 100

d. Dr. Jean deKernion........................................................................................................................ 101

e. Dr. Arthur Burnett......................................................................................................................... 101

f. Dr. Irwin Goldstein........................................................................................................................ 101

5. Determinations on the required level of substantiation................................................................ 102

a. Type of claims............................................................................................................................... 102

b. Type of product............................................................................................................................. 102

c. Feasibility of RCTs....................................................................................................................... 103

d. Conditions where RCTs are necessary......................................................................................... 104

e. Necessary substantiation................................................................................................................ 104

G. Substantiation for Respondents' Heart Disease Claims............................................................... 104

1. Substantiation standard for heart disease claims.......................................................................... 104

2. Overview of cardiovascular disease.............................................................................................. 105

3. Respondents' basic science studies............................................................................................... 107

a. Dr. Aviram's in vitro and in vivo studies...................................................................................... 107

b. In vitro and in vivo studies on nitric oxide................................................................................... 108

c. Experts' analysis on Respondents' basic research......................................................................... 109

d. Determinations on Respondents' basic research........................................................................... 110

4. Overview of Respondents' clinical trials and surrogate markers in clinical studies on heart

disease................................................................................................................................................

110

5. Cardiovascular studies sponsored by Respondents....................................................................... 112
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a. Aviram 2000 Study....................................................................................................................... 112

b. Aviram ACE/BP Study................................................................................................................. 113

i. About the Aviram ACE/BP Study................................................................................................. 113

ii. Experts' analysis on the Aviram ACE/BP Study.......................................................................... 113

iii. Determination on the Aviram ACE/BP Study............................................................................. 114

c. Aviram CIMT/BP Study................................................................................................................ 115

i. About the Aviram CIMT/BP Study............................................................................................... 115

ii. Experts' analysis on the Aviram CIMT/BP Study........................................................................ 116

iii. Determination on the Aviram CIMT/BP Study........................................................................... 117

d. Ornish MP Study........................................................................................................................... 117

i. About the Ornish MP Study.......................................................................................................... 117

ii. Experts' analysis on the Ornish MP Study................................................................................... 119

iii. Determination on the Ornish MP Study...................................................................................... 125

e. Ornish CIMT Study....................................................................................................................... 125

i. About the Ornish CIMT Study...................................................................................................... 125

ii. Experts' analysis of the Ornish CIMT Study................................................................................ 126

iii. Determination on the Ornish CIMT Study.................................................................................. 127

f. Davidson CIMT Study................................................................................................................... 127

i. About the Davidson CIMT Study.................................................................................................. 128

ii. Experts' analysis of the Davidson CIMT Study........................................................................... 130

iii. Determination on the Davidson CIMT Study............................................................................. 134

g. Davidson BART/FMD Study........................................................................................................ 134

i. About the Davidson BART/FMD Study....................................................................................... 134

ii. Experts' analysis of the Davidson BART/FMD Study................................................................. 135

iii. Determination on the Davidson BART/FMD Study................................................................... 136

6. Additional biomarker studies sponsored by Respondents............................................................ 136

a. The Overweight Studies................................................................................................................ 136

i. About the Denver Study................................................................................................................ 136

ii. About the San Diego Study.......................................................................................................... 137
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iii. Experts' analysis of the Overweight Studies............................................................................... 139

iv. Determination on the Overweight Studies................................................................................... 139

b. The Diabetes Studies..................................................................................................................... 139

i. About the Diabetes Studies............................................................................................................ 139

ii. Experts' analysis of the Diabetes Studies..................................................................................... 140

iii. Determination on the Diabetes Studies....................................................................................... 140

7. Experts' opinions based on the totality of the evidence................................................................ 140

a. Summary of Complaint Counsel's experts' opinions..................................................................... 140

b. Summary of Respondents' experts' opinions................................................................................. 141

8. Conclusions.................................................................................................................................... 142

H. Substantiation for Respondents' Prostate Cancer Claims............................................................. 143

1. Substantiation standard for prostate claims.................................................................................. 143

2. Background facts on prostates and the effects of pomegranates on prostates............................... 143

a. Prostate function and prostate cancer............................................................................................ 143

b. Mechanism of action of pomegranates in the prostate................................................................. 145

i. In vivo research reporting reduced inflammation in prostate tumors............................................. 146

ii. In vivo research reporting nuclear factor #B decreased................................................................ 146

3. Basic science studies..................................................................................................................... 148

a. Summary of the studies................................................................................................................. 148

b. Complaint Counsel's experts' opinions of basic research on prostate cancer................................ 150

c. Respondents' experts' opinions of basic research on prostate cancer............................................ 150

d. Determination on Respondents' basic research............................................................................. 150

4. Human clinical studies.................................................................................................................. 151

a. Pantuck Phase II Prostate Cancer Study....................................................................................... 151

i. Background to the Pantuck Study................................................................................................. 151

ii. About the Pantuck Study.............................................................................................................. 152

iii. Follow up to the Pantuck Study.................................................................................................. 153

iv. Statements by Dr. Pantuck about the Pantuck Study.................................................................. 154

b. Carducci Study.............................................................................................................................. 156
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i. Background to the Carducci Study................................................................................................ 156

ii. About the Carducci Study............................................................................................................. 156

iii. Results of the Carducci Study..................................................................................................... 157

iv. Statements by Dr. Carducci about the Carducci Study............................................................... 157

c. Expert opinion on the human clinical studies............................................................................... 158

i. Complaint Counsel's experts on the Pantuck Study...................................................................... 158

ii. Complaint Counsel's experts on the Carducci Study.................................................................... 160

iii. Complaint Counsel's experts on PSA doubling time................................................................... 160

iv. Respondents' experts on both clinical studies.............................................................................. 161

(a) PSA doubling time....................................................................................................................... 161

(b) Placebo control arm..................................................................................................................... 162

(c) Respondents' experts' conclusions............................................................................................... 162

5. Determinations on the human clinical studies.............................................................................. 164

a. PSA doubling time........................................................................................................................ 164

b. Research results............................................................................................................................. 166

6. Conclusions.................................................................................................................................... 166

I. Substantiation for Respondents' Erectile Dysfunction Claims...................................................... 167

1. Substantiation standard for erectile dysfunction claims................................................................ 167

2. Background facts on erectile health and dysfunction................................................................... 167

a. Erectile health distinguished from erectile dysfunction................................................................ 167

b. Physiology of human penile erection............................................................................................ 168

c. The role of nitric oxide in human penile erection........................................................................ 169

d. Antioxidant activity of pomegranate juice.................................................................................... 171

3. Erectile dysfunction studies.......................................................................................................... 171

a. Tools for human clinical studies evaluating erectile function...................................................... 172

i. The IIEF......................................................................................................................................... 172

ii. The GAQ....................................................................................................................................... 173

b. The Forest/Padma-Nathan Study................................................................................................... 174

i. About the Forest/Padma-Nathan Study.......................................................................................... 174
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ii. Results of the Forest/Padma-Nathan Study.................................................................................. 176

iii. Expert opinion on the Forest/Padma-Nathan Study.................................................................... 177

iv. Determinations on the Forest/Padma-Nathan Study.................................................................... 179

c. Davidson BART/FMD Study........................................................................................................ 180

d. Nitric oxide studies....................................................................................................................... 181

i. Studies sponsored by Respondents................................................................................................ 181

(a) Dr. Aviram's Study...................................................................................................................... 181

(b) Dr. Azadzoi's Study..................................................................................................................... 182

(c) Dr. de Nigris Study One.............................................................................................................. 183

(d) Dr. de Nigris Study Two............................................................................................................. 184

(e) Dr. Ignarro's Study....................................................................................................................... 185

ii. Expert opinions on the basic science relied upon by Respondents.............................................. 185

4. Determinations............................................................................................................................... 187

5. Conclusions.................................................................................................................................... 188

J. Materiality...................................................................................................................................... 188

1. Overview........................................................................................................................................ 188

2. OTX A&U Study and Zoomerang survey.................................................................................... 190

3. Reibstein Survey............................................................................................................................ 192

K. Remedy......................................................................................................................................... 197

1. Roll Global and POM entities....................................................................................................... 197

2. The Resnicks................................................................................................................................. 199

3. Matthew Tupper............................................................................................................................ 201

III. ANALYSIS................................................................................................................................. 204

A. Burden of Proof............................................................................................................................ 204

B. Jurisdiction.................................................................................................................................... 205

C. Scope of Challenged Advertisements in this Case....................................................................... 206

1. “Advertisements”........................................................................................................................... 206

2. “Food” or “drug”........................................................................................................................... 210

D. Overview of Applicable Law....................................................................................................... 211
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E. Whether Respondents Disseminated Advertisements Conveying the Alleged Claims................. 211

1. General principles.......................................................................................................................... 211

a. Facial analysis................................................................................................................................ 213

b. Extrinsic evidence......................................................................................................................... 214

c. Intent of the advertiser.................................................................................................................. 216

d. Target audience............................................................................................................................. 218

2. Respondents disseminated advertisements making the claims alleged in the Complaint............. 220

a. Summary of findings..................................................................................................................... 220

b. “Establishment” claims vs. “efficacy” claims............................................................................... 225

c. Heart disease claims...................................................................................................................... 225

d. Prostate cancer claims................................................................................................................... 228

e. Erectile dysfunction....................................................................................................................... 229

f. Respondents' arguments as to advertisement interpretation.......................................................... 230

F. Whether the Challenged Claims are False or Misleading............................................................ 234

1. Overview of applicable legal standards........................................................................................ 234

2. Appropriate level of substantiation generally............................................................................... 238

a. RCTs are not a legal requirement................................................................................................. 238

b. Summary of expert testimony on the appropriate level of substantiation..................................... 241

c. Overview as to the appropriate level of substantiation................................................................. 242

i. Expert testimony does not establish that RCTs are required in this case...................................... 242

ii. Expert testimony on the appropriate level of substantiation........................................................ 243

(a) The products involved................................................................................................................. 244

(b) The type of claim........................................................................................................................ 246

(c) The benefits of a truthful claim and the ease of developing substantiation for the claim............ 247

(d) The consequences of a false claim.............................................................................................. 248

(e) The amount of substantiation experts in the field would agree is reasonable............................. 250

3. Substantiation for Respondents' heart disease claims................................................................... 250

a. Overview........................................................................................................................................ 250

i. Summary of expert opinions.......................................................................................................... 250
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ii. Standard for substantiation............................................................................................................ 253

b. Scientific evidence relied upon..................................................................................................... 253

i. Overview of cardiovascular heart disease..................................................................................... 253

ii. In vitro and in vivo studies........................................................................................................... 254

iii. Clinical trials; overview............................................................................................................... 256

iv. Clinical trials; improving blood pressure..................................................................................... 256

(a) About the studies......................................................................................................................... 256

(b) Expert opinions on the studies.................................................................................................... 257

(c) Determination............................................................................................................................... 259

v. Clinical trials; reducing arterial plaque......................................................................................... 260

(a) About the Aviram CIMT/BP Study............................................................................................. 260

(b) Expert opinions on the Aviram CIMT/BP Study........................................................................ 260

(c) About the Davidson CIMT Study............................................................................................... 261

(d) Expert opinions on the Davidson CIMT Study........................................................................... 262

(e) The Ornish CIMT Study.............................................................................................................. 264

(f) Determination............................................................................................................................... 265

vi. Clinical trials; improving blood flow.......................................................................................... 265

(a) About the Ornish MP Study........................................................................................................ 265

(b) Expert opinions on the Ornish MP Study................................................................................... 266

(c) Determination............................................................................................................................... 269

c. Conclusion..................................................................................................................................... 270

4. Substantiation for Respondents' prostate cancer claims............................................................... 270

a. Overview........................................................................................................................................ 270

i. Summary of expert opinions.......................................................................................................... 270

ii. Standard for substantiation............................................................................................................ 273

b. Scientific evidence relied upon..................................................................................................... 273

i. In vitro and in vivo studies............................................................................................................ 273

ii. Clinical trials................................................................................................................................. 275

(a) The Pantuck Study....................................................................................................................... 275
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(b) The Carducci Study..................................................................................................................... 277

(c) Expert Opinions of the Pantuck and Carducci Studies............................................................... 278

c. Conclusion..................................................................................................................................... 282

5. Substantiation for Respondents' erectile dysfunction claims........................................................ 283

a. Overview........................................................................................................................................ 283

i. Summary of expert opinions.......................................................................................................... 283

ii. Standard for substantiation............................................................................................................ 285

b. Scientific evidence relied upon..................................................................................................... 285

i. In vitro and in vivo studies............................................................................................................ 286

ii. Clinical trial................................................................................................................................... 287

c. Conclusion..................................................................................................................................... 288

6. Summary........................................................................................................................................ 289

G. Whether Respondents' Claims are Material................................................................................. 290

1. Overview........................................................................................................................................ 290

2. Evidence of materiality................................................................................................................. 292

3. Respondents' evidence of immateriality........................................................................................ 295

4. Conclusion..................................................................................................................................... 296

H. Remedy......................................................................................................................................... 296

1. General legal principles................................................................................................................. 296

2. Respondents' preliminary arguments............................................................................................. 297

a. Outliers........................................................................................................................................... 298

b. Liability of Roll............................................................................................................................. 299

3. Liability of Individual Respondents.............................................................................................. 300

a. Applicable legal principles............................................................................................................ 300

b. Stewart and Lynda Resnick.......................................................................................................... 301

c. Matthew Tupper............................................................................................................................. 302

i. “Control” as a mandatory prerequisite to finding individual liability of corporate officer............ 302

ii. Mr. Tupper's participation in and control over the practices at issue in this case......................... 305

iii. Breadth of cease and desist order................................................................................................ 308
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4. Provisions of the Order................................................................................................................. 309

a. Multi-product coverage (Order, Definitions para. 5).................................................................... 309

b. Part I of the Order......................................................................................................................... 314

c. Part I of the proposed order (FDA pre-approval substantiation requirement)............................... 315

d. Part II of the Order....................................................................................................................... 324

e. Part III of the Order...................................................................................................................... 324

f. Miscellaneous provisions............................................................................................................... 324

5. Conclusion..................................................................................................................................... 325

IV. SUMMARY OF CONCLUSIONS OF LAW......................................................................... 326

ORDER............................................................................................................................................. 331

APPENDIX

I. INTRODUCTION

A. Summary of Complaint and Answer

*1 The Complaint, issued September 24, 2010, alleges that Respondents POM Wonderful LLC, Roll Global

LLC, Stewart A. Resnick, Lynda Rae Resnick, and Matthew Tupper (“Respondents”) disseminated advertising

and promotional materials representing that the consumption of eight ounces of POM Juice, one POMx Pill, or

one teaspoon of POMx Liquid (the “POM Products”) daily “prevents or reduces the risk of” or “treats” heart

disease, prostate cancer or erectile dysfunction. Complaint ¶¶ 9, 10, 19. Because, according to the Complaint,

Respondents represented that they possessed and relied upon, but in fact did not possess or rely upon a reasonable

basis substantiating such claims, Respondents' representations were false or misleading. Complaint ¶¶ 19-21.

The Complaint further alleges that Respondents disseminated advertising and promotional materials representing

that “clinical studies, research, and/or trials prove” that consuming the POM Products “prevents or reduces the risk

of” or “treats” heart disease, prostate cancer or erectile dysfunction. Complaint ¶ ¶ 9, 10, 12, 14, 16. The Complaint

further asserts that these representations are false or misleading because, in fact, clinical studies, research, and/or

trials do not prove that consuming the POM Products, “prevents or reduces the risk of” or “treats” heart disease,

prostate cancer or erectile dysfunction. Complaint ¶¶ 13, 15, 17, 18.

The Complaint concludes that the foregoing acts and practices of Respondents constitute unfair or deceptive acts

or practices, and false advertising, in violation of sections 5(a) and 12 of the Federal Trade Commission Act.

Complaint ¶ 22.

Respondents filed their Answer to the Complaint on October 18, 2010. While admitting that they disseminated the

advertising and promotional materials attached as exhibits to the Complaint, they denied that such materials make

the claims alleged. Answer ¶¶ 9, 10, 12, 14, 16, 19. Respondents also deny making false or misleading claims,
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and further aver that “there is substantial scientific research indicating the health benefits of [the POM Products]

and substantiating their advertising and promotional materials.” Answer ¶¶ 13, 15, 17, 18, 21, 22.

B. Procedural History

The administrative hearing (also referred to herein as the “trial” or “administrative trial”) in the instant case began

on May 24, 2011 and concluded on November 4, 2011. By Order dated November 18, 2011, the hearing record

was closed. The hearing record is voluminous. Nearly 2000 exhibits were admitted. Among these exhibits are

the advertisements and promotional materials upon which Complaint Counsel relies to prove that Respondents

made the representations alleged in the Complaint. These consist of: 27 print advertisements, some of which

comprise multiple pages; 2 multi-page newsletters; 7 separate “web captures” of Respondents' 3 websites, recorded

at multiple points in time; 2 internet “banner” advertisements; 4 press releases; and 4 television interviews (the

“Challenged Advertisements”); see Complaint Counsel's Post-Hearing Brief, Appendix A. Also included in the

exhibits are more than 46 scientific studies sponsored by Respondents and offered on the issue of substantiation,

numerous consumer surveys, and 14 expert reports. In addition, 24 witnesses testified, either live or by deposition,

including 14 expert witnesses, and there are 3,273 pages of trial transcript. The parties submitted 3,929 proposed

findings of fact (1,130 by Complaint Counsel and 2,799 by Respondents). The parties' proposed findings of fact

and conclusions of law, replies to proposed findings of fact and conclusions of law, post-trial briefs, and reply

briefs total 3,396 pages.

Commission Rule 3.51(a) states that the Administrative Law Judge (“ALJ”) shall file an initial decision within

70 days after the filing of the last filed initial or reply proposed findings of fact, conclusions of law and order

pursuant to Commission Rule 3.46 and that the Administrative Law Judge may extend this time period by up to

30 days for good cause. 16 C.F.R. § 3.51(a). The parties filed concurrent post-trial briefs and proposed findings of

fact on January 7, 2012. The parties filed replies to the other's proposed findings and briefs on February 7, 2012.

Pursuant to Commission Rule 3.41(b)(6), closing arguments were held on March 6, 2012. 1

Seventy days from the last filed reply proposed findings and conclusions and briefs was April 17, 2012 and, absent

an order pursuant to Rule 3.51, the Initial Decision was to be filed on or before April 17, 2012. Based on the

voluminous and complex record in this matter and other grounds, an Order was issued on April 16, 2012 finding

good cause for extending the time period for filing the Initial Decision by 30 days. Accordingly, issuance of this

Initial Decision on May 17, 2012 is in compliance with Commission Rule 3.51(a).

C. Evidence

This Initial Decision is based on a consideration of the whole record relevant to the issues, including the exhibits

properly admitted into evidence, deposition transcripts, and the transcripts of testimony at trial, and addresses

the material issues of fact and law. The briefs and proposed findings of fact and conclusions of law, and the

replies thereto, submitted by the parties were thoroughly reviewed. Proposed findings of fact submitted by the

parties, but not included in this Initial Decision were rejected, either because they were not supported by the

evidence or because they were not dispositive or material to the determination of the allegations of the Complaint

or the defenses thereto. The Commission has held that Administrative Law Judges are not required to discuss the

testimony of each witness or all exhibits that are presented during the administrative adjudication. In re Amrep

Corp., No. 9018, 102 F.T.C. 1362, 1670, 1983 FTC LEXIS 17, *566-67 (Nov. 2, 1983). Further, administrative

adjudicators are “not required to make subordinate findings on every collateral contention advanced, but only

upon those issues of fact, law, or discretion which are ‘material.”’ Minneapolis & St. Louis Ry. Co. v. United

States, 361 U.S. 173, 193-94 (1959); accord Stauffer Labs., Inc. v. FTC, 343 F.2d 75, 82 (9th Cir. 1965). See also

Borek Motor Sales, Inc. v. National Labor Relations Bd., 425 F.2d 677, 681 (7th Cir. 1970) (holding that it is

adequate for the Board to indicate that it had considered each of the company's exceptions, even if only some of the
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exceptions were discussed, and stating that “[m]ore than that is not demanded by the [Administrative Procedure

Act] and would place a severe burden upon the agency”).

Under Commission Rule 3.51(c)(1), “[a]n initial decision shall be based on a consideration of the whole record

relevant to the issues decided, and shall be supported by reliable and probative evidence.” 16 C.F.R. § 3.51(c)

(1); see In re Chicago Bridge & Iron Co., No. 9300, 138 F.T.C. 1024, 1027 n.4, 2005 FTC LEXIS 215, at *3 n.4

(Jan. 6, 2005). Under the Administrative Procedure Act (“APA”), an Administrative Law Judge may not issue an

order “except on consideration of the whole record or those parts thereof cited by a party and supported by and

in accordance with the reliable, probative, and substantial evidence.” 5 U.S.C. § 556(d). All findings of fact in

this Initial Decision are supported by reliable, probative, and substantial evidence. Citations to specific numbered

findings of fact in this Initial Decision are designated by “F.” 2

Pursuant to Commission Rule 3.45(b), several orders were issued in this case granting in camera treatment to

material, after finding, in accordance with the Rule, that its public disclosure would likely result in a clearly

defined, serious injury to the entity requesting in camera treatment. 16 C.F.R. § 3.45(b). Commission Rule 3.45(a)

allows the Administrative Law Judge “to grant in camera treatment for information at the time it is offered

into evidence subject to a later determination by the [administrative] law judge or the Commission that public

disclosure is required in the interests of facilitating public understanding of their subsequent decisions.” In re

Bristol-Myers Co., Nos. 8917-19, 90 F.T.C. 455, 457, 1977 FTC LEXIS 25, at *6 (Nov. 11, 1977). As the

Commission later reaffirmed in another leading case on in camera treatment, since “in some instances the ALJ or

Commission cannot know that a certain piece of information may be critical to the public understanding of agency

action until the Initial Decision or the Opinion of the Commission is issued, the Commission and the ALJs retain

the power to reassess prior in camera rulings at the time of publication of decisions.” In re General Foods Corp.,

No. 9085, 95 F.T.C. 352, 356 n.7; 1980 FTC LEXIS 99, at *11 n.7 (March 10, 1980). Thus, in instances where a

document had been given in camera treatment, but the portion of the material cited to in this Initial Decision does

not in fact require in camera treatment, such material is disclosed in the public version of this Initial Decision,

pursuant to Commission Rule 3.45(a) (the ALJ “may disclose such in camera material to the extent necessary

for the proper disposition of the proceeding”). This Initial Decision does not contain any material that requires

in camera treatment.

D. Summary of Initial Decision

The preponderance of the evidence shows that some of the Challenged Advertisements disseminated by

Respondents would reasonably be interpreted by consumers to contain an implied claim that the POM Products

treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, and further, as to some of

these advertisements, that these effects were clinically proven, as alleged in the Complaint. These advertisements

are attached to this Initial Decision as an Appendix. As to other Challenged Advertisements disseminated by

Respondents, the preponderance of the evidence fails to demonstrate that such advertisements would reasonably

be interpreted by consumers as containing such claims.

The evidence further shows that the appropriate level of substantiation for claims that a product treats, prevents,

or reduces the risk of a disease is competent and reliable scientific evidence. The evidence also demonstrates that

where such claims are made in connection with a food, or food-derived product, that is safe, and that is not being

offered as a substitute for medical treatment, double-blind, randomized, placebo-controlled clinical trials, such as

those required by the Food and Drug Administration, are not required. However, for claims that a food or foodderived product treats, prevents, or reduces the risk of a disease, experts in the relevant fields would agree that

competent and reliable scientific evidence must include clinical studies, although not necessarily double-blind,

randomized, placebo-controlled clinical trials, that are adequate to show that the product did treat, prevent, or

reduce the risk of disease.
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Notwithstanding the fact that double-blind, randomized, placebo-controlled clinical trials are not required to

substantiate Respondents' implied claims for the POM Products, the evidence demonstrates that Respondents'

substantiation was, nevertheless, inadequate. Regardless of whether competent and reliable scientific evidence

existed to substantiate highly qualified or generalized health claims about the POM Products, the weight of the

persuasive expert testimony demonstrates that there was insufficient competent and reliable scientific evidence to

support the implied claims in some of the Challenged Advertisements disseminated by Respondents, that the POM

Products treat, prevent or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, or were clinically

proven to do so. Whether or not Respondents' substantiation was adequate to support the express language of

the advertisements is not the material issue. Because Respondents' substantiation was inadequate to support the

implied claims, such claims were false or misleading within the meaning of Section 12 of the Federal Trade

Commission Act (“FTC Act”), as interpreted by applicable case law. The evidence further shows that such healthrelated efficacy claims are material to consumers. Accordingly, the preponderance of the evidence supports the

conclusion that Respondents violated Sections 5 and 12 of the FTC Act.

Pursuant to Section 5(b) of the FTC Act, a cease and desist order is entered herewith (the “Order”), the provisions

of which will serve to prevent Respondents from engaging in deceptive advertising practices in the future, are

reasonably related to the unlawful acts or practices found to exist, and are sufficiently clear and precise. The

Order is binding upon the corporate Respondents as well as the individual Respondents, and covers any food,

drug or dietary supplement that may be advertised by Respondents in the future. Neither applicable law nor the

evidence in this case supports Complaint Counsel's proposed provision prohibiting Respondents from making any

disease claim in the future, unless the claim has received prior approval from the Food and Drug Administration

in accordance with Food and Drug Administration statutes and regulations.

II. FINDINGS OF FACT

A. The Respondents

1. POM Wonderful LLC

1. POM Wonderful (“POM Wonderful” or “POM”) is a limited liability company organized under the laws of the

State of Delaware. (Complaint ¶ 1; CX1367 at 0002 (S. Resnick, Welch's Dep. at 8); CX1437; Answer ¶ 1).

2. POM Wonderful's principal office or place of business is at 11444 West Olympic Boulevard, Los Angeles,

California 90064. (Complaint ¶ 1; Answer ¶ 1).

3. POM Wonderful is wholly owned by the Stewart and Lynda Resnick Revocable Trust, dated December 27,

1988 (the “Resnick Trust”). (Complaint ¶ 1; Answer ¶ 1; CX1384 at 0008).

4. Respondent POM Wonderful is a member-managed company, and the Resnick Trust is the sole member.

(Complaint ¶ 1; Answer ¶ 1).

5. In 2002, POM first launched POM Wonderful 100% Pomegranate Juice, a premium, all-natural pomegranate

juice made from pomegranates grown from POM's orchards. (L. Resnick, Tr. 145-46).

6. POM Wonderful is currently in the business of selling fresh pomegranates and pomegranate-related products,

including 100% pomegranate juice (“POM Juice”) and pomegranate extract products known as POMx pills and

POMx liquid (“POMx”) (“the POM Products”). (S. Resnick, Tr. 1630-31; CX1364 at 0005 (Tupper, Coke Dep.

at 20); CX1374 (Tupper, Ocean Spray Dep. at 26); CX1363 at 0012 (S. Resnick, Coke Dep. at 45-46)).
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2. Respondent Roll Global LLC

7. Roll International Corporation is a separate corporation organized under the laws of the State of Delaware.

(Complaint ¶ 2; Answer ¶ 2).

8. Roll International Corporation was reorganized at the end of 2010 and is currently known as Roll Global

(“Roll”). (S. Resnick, Tr. 1629).

9. Roll is wholly owned by the Resnick Trust. (Complaint ¶ 2; Answer ¶ 2).

10. Roll is a privately held corporation. (S. Resnick, Tr. 1630).

11. POM Wonderful, FIJI Water, Suterra, Paramount Farms, Paramount Citrus, Teleflora, Neptune Shipping,

Paramount Farming, and Justin Winery are among the separate operating businesses under Roll's ownership

umbrella (hereafter “affiliated companies”). (CX1364 at 0004-05 (Tupper, Coke Dep. at 16-17); CX1374 (Tupper,

Ocean Spray Dep. at 36); Perdigao, Tr. 593-94).

*2 12. Stewart and Lynda Resnick are the sole owners of Roll and its affiliated companies, including POM

Wonderful. (S. Resnick, Tr. 1629; CX1360 (S. Resnick, Dep. at 15); CX1376 (S. Resnick, Ocean Spray Dep.

at 13-14)).

13. Roll's affiliated companies pay Roll for certain provided services. (CX1376 (S. Resnick, Ocean Spray Dep. at

24-25); L. Resnick, Tr. 89; CX1359 (L. Resnick, Dep. at 26); Perdigao, Tr. 616-17).

14. Fire Station acts as Roll's in-house advertising agency. Fire Station bills POM and other Roll affiliated

companies separately. (CX1376 (S. Resnick, Ocean Spray Dep. at 24-25); L. Resnick, Tr. 88-89; CX1359 (L.

Resnick, Dep. at 26); Perdigao, Tr. 616-17).

3. Respondents Stewart and Lynda Resnick

15. POM Wonderful is owned solely by Stewart and Lynda Resnick (“the Resnicks”). (S. Resnick, Tr. 1629;

CX1360 (S. Resnick, Dep. at 15).

16. The Resnicks have been, and currently are, the sole trustees and beneficiaries of the Resnick Trust. (Complaint

¶ 1; Answer ¶ 1; CX1421 at 0002-03; CX1384 at 0008).

17. The Resnick Trust had owned Roll International Corporation and POM. (JX0001 ¶¶ 10-11, 18; Complaint

¶¶ 1-2; Answer ¶¶ 1-2).

18. The Resnicks are the sole owners of Roll Global, the successor-in-interest to Roll International Corporation,

and its affiliated companies, including POM. (JX0003 ¶ B.2; S. Resnick, Tr. 1629; CX1360 (S. Resnick, Dep. at

15); CX1376 (S. Resnick, Ocean Spray Dep. at 13)).

19. Stewart Resnick (“Mr. Resnick”) is, and at all times relevant to this action has been, the Chairman and President

of Roll. (JX0001 ¶¶ 12, 18; S. Resnick, Tr. 1629; Complaint ¶ 3; Answer ¶ 3; CX1384 at 0008; CX1363 at 0014

(S. Resnick, Coke Dep. at 54-55)).
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20. Mr. Resnick is, and at all times relevant to this action has been, the Chairman of POM Wonderful. (Complaint

¶ 3; Answer ¶ 3).

21. Mr. Resnick is the Chief Executive Officer of POM. (S. Resnick, Tr. 1869).

22. Mr. Resnick's responsibilities include making final decisions about POM's investments and corporate

expansion. (S. Resnick, Tr. 1631; CX1360 (S. Resnick, Dep. at 20-21); see also CX1357 (Kuyoomjian, Dep. at

154-56) (testifying that Mr. Resnick's participation in POM's business included involvement in strategic planning

and financial decisions as well as providing feedback on POM's advertising)).

23. Mr. Resnick spends the second greatest amount of his time on the POM business and, among other activities,

sets the overall budgets for POM, including the marketing and advertising and medical research budgets. He has

been intimately involved in the development of POM's scientific research program. (S. Resnick, Tr. 1631-32; CX

1363 at 0014 (S. Resnick, Coke Dep. at 56); CX1367 at 0014 (S. Resnick, Welch Dep. at 55)).

24. Mr. Resnick's authority includes “any decisions made with respect to what ... [POM] talk[s] about, [and] how ...

[POM] talk[s] about it,” including “authority for advertising the benefits of POM.” (Tupper, Tr. 2975).

*3 25. Mr. Resnick leaves the marketing of POM mostly to Mrs. Lynda Resnick. He considers himself ultimately

responsible for whether advertising should or should not go out, although he delegated day-to-day responsibility

to Mr. Matthew Tupper. (Tupper, Tr. 2975; S. Resnick, Tr. 1869-70).

26. When Mrs. Lynda Resnick has chosen to involve him, Mr. Resnick has been involved at a high level with

POM's advertising and marketing campaigns, including on occasion seeing headlines before advertisements were

disseminated. (CX1376 (S. Resnick, Ocean Spray Dep. at 140-42); CX1360 (S. Resnick, Dep. at 50-51)).

27. Lynda Resnick (“Mrs. Resnick”) was, at all times relevant to this action, a director and was Vice Chairman

of Roll International Corporation. (JX0001 ¶ 18; Complaint ¶ 4; Answer ¶ 4; L. Resnick, Tr. 287; CX1359 (L.

Resnick, Dep. at 24-25).

28. Mrs. Resnick is Vice Chairman of Roll Global. (L. Resnick, Tr. 287; CX1359 (L. Resnick, Dep. at 24-25)).

29. Mrs. Resnick is involved in POM's marketing, branding, public relations, and product development. (CX1363

at 0011 (S. Resnick, Coke Dep. at 41); CX1364 at 0007 (Tupper, Coke Dep. at 27); CX1347 (Glovsky, Dep. at 36)).

30. Mrs. Resnick participated in POM's business on almost a daily basis in the company's early years, and on a

weekly or biweekly basis thereafter and through 2010, although Mrs. Resnick reduced her day-to-day involvement

in POM's business beginning in 2007 (L. Resnick, Tr. 86, 93, 157-58; see also CX1375 (L. Resnick, Tropicana

Dep. at 19-22, 78); CX1359 (L. Resnick, Dep. at 22, 108)).

31. As of 2011, Mrs. Resnick was still the chief marketing person at POM. (L. Resnick, Tr. 289), and this was

also her role in 2010 and 2009. (CX1375 (L. Resnick, Tropicana Dep. at 24); CX1362 (L. Resnick, Coke Dep.

at 47, 77-78)).

32. Mrs. Resnick commissioned, helped develop, and used consumer and marketing research for POM's business.

(CX1359 (L. Resnick, Dep. at 76-78).
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33. Mrs. Resnick has worked with POM's marketing department and Roll's advertising agency, Fire Station, along

with scientists and public relations personnel, to implement creative concepts for POM marketing pieces and

campaigns. It was a team approach. (L. Resnick, Tr. 87-89; see also CX0409; CX0410; CX1359 (S. Resnick,

Dep. at 70)).

34. Mrs. Resnick has the “final say” with respect to POM's marketing and advertising content and concepts.

(CX1368 at 0003 (L. Resnick, Welch's Dep. at 9); L. Resnick, Tr. 93).

35. According to Mrs. Resnick, when it comes to marketing and creative issues, everyone has a “dotted line” to

her, meaning she is in a position of authority even though she may not have day-to-day responsibilities for each

employee. (CX1375 (L. Resnick, Tropicana Dep. at 24); L. Resnick, Tr. 287-88).

4. Respondent Matthew Tupper

36. Respondent Matthew Tupper (“Mr. Tupper”) joined Roll in May 2001 as Vice President of strategy. (JX0003

¶ B.5).

37. Mr. Tupper joined POM as a full-time employee in 2003, as Chief Operating Officer. (JX0001 ¶¶ 12, 18;

Tupper, Tr. 886-87).

*4 38. In 2005, his title at POM changed to President, but his responsibilities did not change from those in his

position as Chief Operating Officer. (JX0001 ¶¶ 12, 18; Tupper, Tr. 886-87).

39. Mrs. Resnick considers Mr. Tupper as having been her “partner at POM since 2003.” (CX0001 at 0037; L.

Resnick, Tr. 230).

40. Mr. Tupper retired from POM at the end of the 2011. (Tupper, Tr. 2973).

41. Mr. Tupper will not be working for Roll Global or any other company owned by the Resnicks after his

retirement from POM. (Tupper, Tr. 2974).

42. In his capacity as an officer of POM, Mr. Tupper, together with others, formulated, directed, or controlled the

policies, acts, or practices of POM. (Complaint ¶ 5, Answer ¶ 5).

43. Mr. Tupper reported to the Resnicks. Mr. Tupper reported directly to Mr. Resnick. Mr. Tupper had a “dotted

line” reporting to Mrs. Resnick. (CX1367 at 0014 (S. Resnick, Welch Dep. at 53); CX1364 at 0007, 0027 (Tupper,

Coke Dep. at 27-28, 107); CX1375 (L. Resnick, Tropicana Dep. at 23-24)).

44. Mr. Tupper was responsible for managing the day-to-day affairs of POM, which employs roughly 350 people

worldwide, including management of the day-to-day operations of the POM marketing team. (JX0003 ¶ B.6;

Tupper, Tr. 2974; CX1363 at 0011 (S. Resnick, Coke Dep. at 42)).

45. Mr. Tupper oversaw and administered POM's budget for all departments, and had authority to sign checks and

contracts on behalf of the company. (Tupper, Tr. 903-04, 912-13; CX0606 at 0003).

46. Mr. Tupper's activities included hiring and firing POM employees, including the head of POM's marketing

department, on his own, or, depending on the situation, in consultation with either Mr. or Mrs. Resnick. (Tupper,
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Tr. 902-03; see also CX1360 (S. Resnick, Dep. at 22-23); CX1359 (L. Resnick, Dep. at 41, 45); CX1353 (Tupper,

Dep. at 24-25)).

47. At POM, nine or ten people have directly reported to Mr. Tupper, including the Vice President of Marketing

(including former Senior Vice President of Marketing, Diane Kuyoomjian, (“Ms. Kuyoomjian”), the Vice

President of Clinical Development (currently Bradley Gillespie (“Dr. Gillespie”)), and the head of the Operations

Department. (Tupper, Tr. 888-89, 2974; CX1353 (Tupper, Dep. at 24-25); CX1378 at 0008 (Kuyoomjian, Ocean

Spray Dep. at 27)).

48. Mark Dreher, Ph.D. (“Dr. Dreher”), POM's former Vice President of Scientific and Regulatory Affairs,

reported to Mr. Tupper. (Dreher, Tr. 527, 529; L. Resnick, Tr. 249).

49. Fiona Posell (“Ms. Posell”), former Vice President of Corporate Communications at Roll and POM, reported

to Mr. Tupper and Mrs. Resnick. (Posell, Tr. 299, 321, 325).

50. The head of POM's Marketing department reported to Mr. Tupper, as did the departments with sales

responsibilities. (Tupper, Tr. 891).

51. Mr. Tupper's responsibilities within POM included implementing POM's direction with regard to health benefit

advertising and the use of science in connection with the advertising. With respect to this advertising, Mr. Tupper

was the “connecting piece” between the marketing vision and the communication of the science. It was Mr.

Tupper's job to work with all parts of the POM team, including marketing, scientists, and lawyers, to make sure

that the advertising was done in “the right way.” (Tupper, Tr. 2975-76).

*5 52. One of Mr. Tupper's responsibilities was to be a liaison between the marketing staff of POM and the

researchers in studies sponsored by POM, to help the marketing team “wade through” the science, of which Mr.

Tupper had some understanding. (L. Resnick, Tr. 261; Tupper, Tr. 899, 914).

53. Mr. Tupper had a significant degree of involvement in the research aspects of POM's business, and his

responsibilities included discussing which research areas are appropriate for funding, participating in the internal

decision-making as to what research to fund, and overseeing for POM the clinical trials on POM's products that

were conducted by research institutions. (Tupper, Tr. 895-96, 906; see also CX0770; CX0779; CX0800; CX0919;

CX0920 (showing Tupper's participation in managing POM's medical and scientific research)).

B. The POM Products

1. Description of the POM Products

54. Respondents have manufactured, advertised, labeled, offered for sale, sold, and distributed products to the

public, including POM Juice, POMx Pills, and POMx Liquid. (Answer 6; Complaint 6).

55. The Complaint in this case challenges Respondents' advertisements with respect to three products: POM Juice,

POMx Pills, and POMx Liquid. (Complaint 6, 9, 10).

56. Respondents also manufacture, advertise, and sell other products containing pomegranate, including various

POM Juice blends, Lite POM Juice, POMx bars, POMx iced tea and iced coffee, and a POMx sports recovery

beverage. (JX0003 B.8).
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a. POM Juice

57. POM Juice is a 100% juice product derived from whole pomegranate fruits. (PX0353 (Heber, Dep. at 124);

CX1362 (L. Resnick, Dep. at 85-86); CX1363 (S. Resnick, Dep. at 46-47)).

58. POM Juice is produced by pressing whole pomegranates, including the arils and peels. (CX0967at 0014, in

camera). The subsequent cloudy juice is filtered and/or enzyme treated before concentrating. (CX0537 at 0003).

59. The concentrate from POM Juice is stored in 52-gallon drums. (CX1369 (Tupper, Welch Dep. at 22)).

60. To make it ready for sale, the concentrate is reconstituted with water to make “100 percent pomegranate juice,”

pasteurized, and bottled for sale. (JX0003 B.9; CX1369 (Tupper, Welch Dep. at 19-23)).

61. The final POM Juice product contains “85.4% water, 10.6% total sugars, 1.4% pectin, 0.2-1.0% polyphenols,

and organic acids.” (CX0537 at 0003).

62. POM Juice does not contain dietary fiber or vitamin C. (CX0537 at 0014; CX0716 at 0041).

63. POM Juice contains a variety of polyphenols, including 80 to 90% ellagitannins and gallotannins, 8 to 15%

anthocyanins and 2 to 5% ellagic acid. (CX0163 at 0007).

64. A single serving of POM Juice is eight ounces. (CX1379 at 0008, in camera). A serving of POM Juice provides

140 calories and 34 grams of sugar. (CX1306 (Weidner, Decl. at 0020)).

65. POM Juice is sold in the refrigerated produce section of the grocery store. (CX1367 (S. Resnick, Welch Dep.

at 122); CX1374 (Tupper, Ocean Spray Dep. at 56-57)). Consumers must go to the fresh produce aisle of a store

to purchase any POM Juice product. (CX1362 (L. Resnick, Coke Dep. at 135-36).

*6 66. POM Juice is not sold in the “drug” or “over the counter” section of any establishment. (CX1362 (L.

Resnick, Coke Dep. at 135-36); CX1367 (S. Resnick, Welch Dep. at 122; CX1374 (Tupper, Ocean Spray Dep.

at 56-57)).

b. POMx Liquid

67. POMx Liquid “is the product of the pressed whole fruit after most of the juice is extracted and the polyphenols

are concentrated by filtering and concentrating using juice processing.” (CX0096 at 0014, in camera).

68. Consumers can purchase POMx Liquid via the company website or through a telephone call center. (JX0003

B.14).

69. POM's website states that the company's recommended daily serving of POMx Liquid is one teaspoon and

recommends consumers take one teaspoon of POMx Liquid daily. (CX1379 at 0008-09, in camera).

c. POMx Pills
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70. POMx is an extract from the pomegranate, made through a process by which POMx Liquid is first derived

from the whole fruit, and then POMx is extracted from the POMx Liquid. (CX1363 (S. Resnick, Dep. at 46-47)).

71. POMx was created to use up the “tens of thousands of tons of discarded, mashed-up pomegranates left over

from the juicing process.” (CX0001 at 0013; CX0967 at 0014).

72. Consumers can purchase POMx Pills via the company website or through a telephone call center. POMx Pills

also are available through a few U.S. Retail outlets that sell dietary supplement products. (JX0003 B.14).

73. Pomegranate extracts, because of the production process, contain no anthocyanins. (CX1352 (Heber, Dep. at

358); see also CX1258 at 0003 (POMx has only “trace” anthocyanins)).

74. Mrs. Resnick stated “[m]y marketing team and I were eager to learn if we could produce a pomegranate extract

that could deliver the power of eight ounces of POM juice in a capsule.” (CX0001 at 00013).

75. POMx caters to those consumers who want the benefits of the juice, without the calories or sugar to get, “The

Power of POM, in one little pill.” (CX0169 at 0001).

76. POM's website recommends consumers take one POMx Pill daily, preferably with eight ounces of water and

food. (CX1379 at 0008, in camera).

2. Safety of the POM Products

77. Pomegranates have been safely consumed as nutritious food by humans for thousands of years. (PX0192

(Heber Expert Report at 0013, 0018)).

78. Pomegranate juice and pomegranate extract have a “high degree of safety.” (PX0192 (Heber Expert Report

at 0013)).

79. Pomegranate juice is safe for human consumption if consumed within the nutritional range. (PX0192 (Heber

Expert Report at 0018)).

80. POMx is safe for human consumption if consumed within the nutritional range. (PX0192 (Heber Expert Report

at 0018)).

81. Unlike some drugs, pomegranate juice has no adverse side effects. (PX0192 (Heber Expert Report at 0042)).

82. The FDA maintains a list of substances that are identified by the FDA as generally regarded as safe (“GRAS”).

(Heber, Tr. 2008-09).

*7 83. Before a substance can be GRAS identified, the FDA reviews the scientific literature and the traditional

intake of the substance. (Heber, Tr. 2009).

84. Both pomegranate juice and pomegranate extract are GRAS identified. (Heber, Tr. 2009, 2032; 21 C.F.R. §

182.20).

85. There have been no reported cases of persons being harmed by eating a pomegranate or drinking pomegranate

juice. (Heber, Tr. 1947-48).
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86. There have been no reported cases of toxicity where pomegranates or pomegranate juice have been consumed

in nutritional amounts. (Heber, Tr. 1948).

87. In all the studies that have been conducted on pomegranate juice and pomegranate extract, there have never

been any reports of any material harm caused to the subjects by consuming the products. (Heber, Tr. 2007-08;

PX0353 (Heber, Dep. at 115)).

88. None of the clinical studies conducted on pomegranate juice and pomegranate extract found any serious risk

to human health from consuming the products. (PX0192 (Heber Expert Report at 0018)).

89. Pomegranate juice is a food. (PX0192 (Heber Expert Report at 0011)).

90. Pomegranate extract is a food-based dietary supplement that has substances found in pomegranate juice at

levels within the nutritional range. (PX0192 (Heber Expert Report at 0011)).

91. In 2007, in a peer-reviewed study titled, “Pomegranate Juice Does Not Impair Clearance of Oral or

Intravenous Midazolam, a Probe for Cytochrome P450-3A Activity: Comparison With Grapefruit Juice,” by

Farkas D, Oleson L, Zhao Y, Harmatz, J, Zinny M, Court M, and Greenblatt D (J Clin. Pharmocol 2007;

47:286-294), Dr. Greenblatt and his colleagues examined the effect of POM Juice and grapefruit juice on inhibiting

enteric cytocrhome P450-3A activity in healthy human volunteers. The study showed POM Juice did not cause

drug interaction in humans. (PX0136 at 0008).

92. In 2007, in a peer-reviewed study titled, “Safety and Antioxidant Activity of a Pomegranate EllagitanninEnriched Polyphenol Dietary Supplement in Overweight Individuals With Increased Waist Size,” by Heber

D, Seeram N, Wyatt H, Henning S, Zhang Y, Ogden L, Dreher M, and Hill J (J Agric. Food Chem. 2007;

55:-10050-10054), Dr. Heber and his colleagues examined the safety in humans of consuming POMx Pills. The

study reported: Although there were 11 minor adverse events reported by 9 of the 64 subjects, none of these minor

adverse effects were deemed to be related to POMx Pills. The study further reported: no adverse events related

to the POMx Pill consumption or changes in blood count, serum chemistry, or urinalysis were observed in the

subjects. (PX0139 at 0001, 0003, 0004).

93. Complaint Counsel's expert, Dr. Sacks, testified that the issue of the safety of the POM Products was not

within the scope of his assignment in this case, that his expert report contains no opinions on the safety of the

POM Products, and that he has “no opinion about whether [the POM Products are] safe or not.” (PX0361 (Sacks,

Dep. at 74, 76); CX1291 (Sacks Expert Report at 0008-09)).

*8 94. Complaint Counsel's expert, Professor Meir Stampfer, admitted that there are no safety concerns with

consuming pomegranate juice apart from “the usual harm that comes with fruit juice, sugary beverages ... but that

is not specific to pomegranate juice.” (PX0362 (Stampfer, Dep. at 195-96)).

3. Sales of the POM Products

95. Respondents began selling POM Juice in 2002. POM Juice is sold in supermarkets nationally and is a major

seller in the premium juice category. (CX0967 at 0014, in camera).

96. POM's U.S. Sales of 100% Juice, from September 2002 to November 2010, totaled approximately

$247,739,776. (JX0001 15).
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97. For the 52 weeks ending July 20, 2008, the weighted average base price per unit for POM Juice was $2.93 for

an 8-ounce bottle or $4.29 for a 16-ounce bottle. (CX0221 at 0007).

98. In 2007, POM began selling POMx Pills and POMx Liquid. (CX1347 (Glovsky, Dep. at 29-30)).

99. POM's Total POMx Pill Gross Revenue, from May 2007 to November 2010, totaled approximately

$4,017,681. (JX0001 16).

100. POM's Total POMx Liquid Gross Revenue, from May 2007 to November 2010, totaled approximately

$209,820. (JX0001 17).

101. If bought directly from POM's website, POM charges $29.95 (excluding shipping) for a 30-count bottle of

POMx Pills and $77.85 (excluding shipping) for a 90-count bottle of POMx Pills. (CX1379 at 0009-10, in camera).

102. If bought directly from POM's website, POM charges $29.95 (excluding shipping) for a five-ounce bottle of

POMx Liquid. (CX1379 at 0010-11, in camera).

C. Background Facts

1. History of POM and science program

a. Overview

103. In 1987, the Resnicks acquired farmland containing over 100 acres of mature pomegranate trees. (CX0105

at 0002).

104. Between 1989 and 2001, Paramount Farming Company, one of the Roll affiliated companies (F. 11),

continued to acquire and plant additional pomegranate acreage, bringing the total to 6,000 acres by 2001. (CX0105

at 0002-08).

105. In 1998, the Resnicks began collaborating with researchers to determine whether, and to what extent, there

was any truth to the folklore surrounding the health properties of the pomegranate. (L. Resnick, Tr. 150; CX1363

at 0016-17 (S. Resnick, Coke Dep. at 61-66); CX0105 at 0003; CX1362 at 0018 (L. Resnick, Coke Dep. at 71-72);

S. Resnick, Tr. 1853-56); CX1359 (L. Resnick, Dep. at 82); CX1360 (S. Resnick, Dep. at 84-85); CX1372 (S.

Resnick, Tropicana Dep. at 32-33; CX1374 (Tupper, Ocean Spray Dep. at 87); CX1358 (Aviram, Dep. at 4);

CX1367 at 0004(S. Resnick, Welch's Dep. at 15); PX0004).

106. In 2000, the Resnicks formed Paramount Juice Company and, shortly thereafter, in 2001, changed the name

to POM Wonderful LLC. (CX1418 at 0001-03).

107. By spring 2001, the yield from the Resnicks' 6,000 acres of pomegranates “ha[d] progressed exponentially ...

making it essential to immediately begin a marketing program for the POM Juice product.” (CX0004 at 0001).

*9 108. POM began bottling, selling, and marketing POM Juice on a regional basis in the fall of 2002, and in

national markets in 2003. (CX1353 (Tupper, Dep. at 41-42); CX1395 at 0003).
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109. Currently, the Resnicks own approximately 18,000 acres of pomegranate orchards and are the largest growers

of pomegranates in the United States. (CX1374 (Tupper, Ocean Spray Dep. at 29-30)).

110. According to Mrs. Resnick, when Respondents went about creating a market for pomegranate juice, “only

about one in ten Americans said they were familiar with pomegranates, and fewer than half of that group said

they had eaten one in the past year.” (PX0370 at 2).

111. According to Mr. Resnick, a primary part of POM's messaging to consumers is about the health benefits of

its products. (S. Resnick, Tr. 1653; CX1372 (S. Resnick, Tropicana Dep. at 31-32)).

112. Mrs. Resnick has stated her belief that POM juice is “health in a bottle” and that this is part of POM Juice's

unique selling proposition. (CX0001 at 0006; L. Resnick, Tr. 77-78).

113. POM uses the results of studies it has sponsored for marketing purposes, as part of “[POM's] unique selling

proposition.” At least part of the reason for sponsoring studies was for marketing and public relations purposes.

(CX1375 (L. Resnick, Tropicana Dep. at 87); CX1372 (S. Resnick, Tropicana Dep. at 74-75; CX0003 at 0001)).

b. Early research

114. POM began its pomegranate research under the direction of POM's former Medical Director, and the

Resnicks' personal friend and family physician, Dr. Leslie Dornfeld (“Dr. Dornfeld”), a professor of Internal

Medicine at the University of California, Los Angeles (UCLA). (L. Resnick, Tr. 150; CX1350 (Liker, Dep. at

29); CX0105 at 0003).

115. In 1998, Respondents and Dr. Dornfeld collaborated with Dr. Michael Aviram, the Head of the Technion

Lipid Research Laboratory at the Rambam Medical Center in Haifa, Israel, known for his work exploring the

antioxidant properties of red wine, to understand the antioxidant effect and potential cardiovascular benefits of

pomegranate juice. (CX1374 (Tupper, Ocean Spray Dep. at 87); CX1358 (Aviram, Dep. at 4); CX1363at 0016-17

(S. Resnick, Coke Dep. at 61-66); CX1367 at 0004 (S. Resnick, Welch Dep. at 15); CX0001 at 0010-11; L.

Resnick, Tr. 150; PX0004). Dr. Aviram's initial research paper showed that pomegranates possess antioxidative

and antiatherosclerotic properties. (CX1358 (Aviram, Dep. at 7); PX0004).

116. Dr. Dornfeld initially oversaw the development of POM's research program until he was no longer able to

do so for health-related reasons. In 2001, Dr. Dornfeld recruited Dr. Harley Liker (“Dr. Liker”), a physician and

faculty member at UCLA, to be his successor as POM's Medical Director. Dr. Dornfeld and Dr. Liker worked

together until 2002, when Dr. Liker became POM's Medical Director. (Liker, Tr. 1873, 1877; CX1350 (Liker,

Dep. at 15, 27-28); S. Resnick, Tr. 1858).

117. Dr. Liker also became the Resnicks' personal physician and company wellness coordinator and wellness

director in 2001. (Liker, Tr. 1876-77).

*10 118. Respondents hired Risa Schulman, who was POM's Director of Research and Development from

approximately 2002 to 2005. POM subsequently hired Dr. Mark Dreher (“Dr. Dreher”) in 2005 as Vice President

of Scientific and Regulatory Affairs. (CX0105 at 0016; Dreher, Tr. 527).

119. After identifying an area of scientific interest, Dr. Liker works with Mr. Tupper and Mr. Resnick to determine

the leading experts in that scientific field and contacts them to conduct research for Respondents. (Liker, Tr.

1878-80).
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120. Dr. Dreher's duties primarily entailed exploratory research, which was looking at new products such as POMx

and developing clinical and basic science for new applications for POM products. “Basic science” refers to testtube, animal studies, and preclinical research. Dr. Dreher also arranged for contracts and funding of research with

universities and contract research organizations, provided the materials for testing, and helped to organize the

objectives for the studies and for carrying out the studies. (Dreher, Tr. 528).

121. Dr. Dreher reported to Mr. Tupper and also reported, to a certain extent, to Dr. Liker, to help Dr. Liker

manage the logistics associated with some of the larger studies. Dr. Dreher and Dr. Liker met weekly for the first

two-and-a-half to three years Dr. Dreher was at POM, and then less frequently in the last year of his employment.

(Dreher, Tr. 529-30).

122. After Dr. Dreher left, POM hired Dr. Bradley Gillespie in 2009 as its Vice President of Clinical Development.

(CX1349 (Gillespie, Dep. at 10-11); CX1353 (Tupper, Dep. at 28)).

123. POM has also hired scientific consultants, including Dr. Aviram and Dr. David Heber. (CX1380 at 0005;

CX1349 (Gillespie, Dep. at 264-65); Heber, Tr. 1941; S. Resnick, Tr. 1637).

c. Relevant studies

124. Respondents' studies have explored the effect of POM products on many different areas of health, including

the cardiovascular system, immunity, athletic performance, erectile health, prostate cancer, skin care, cognitive

function, dental health, and urinary tract health. (CX1353 (Tupper, Dep. at 48-52); Tupper, Tr. 2979-81).

125. Respondents' research efforts branch in various directions in order to examine the role that oxidation and

inflammation play in many seemingly unrelated diseases and conditions. (CX1353 (Tupper, Dep. at 47-49);

Tupper, Tr. 2979-81; Heber, Tr. 1957, 2112-13, 2185).

126. The results of five POM-sponsored studies have been referred to in the Challenged Advertisements. The

studies are:

a. A study by Dr. Aviram, published in 2001 titled, Pomegranate Juice Consumption Inhibits Serum Angiotensin

Converting Enzyme Activity and Reduces Systolic Blood Pressure (“Aviram ACE/BP Study”). The Aviram ACE/

BP Study, conducted on ten patients, examined the effect of POM Juice consumption on angiotensin converting

enzyme (“ACE”). (CX0542; see e.g., CX0013 at 0003; CX0031; CX0473 (Compl. Ex. E-2 at 00:30, 1:25)).

*11 b. A study by Dr. Aviram, published in 2004 titled, Pomegranate Juice Consumption for 3 Years by

Patients with Carotid Artery Stenosis Reduces Common Carotid Intima-Media Thickness, Blood Pressure and

LDL Oxidation (“Aviram CIMT/BP Study”). The Aviram CIMT/BP Study, conducted on 19 patients, examined

the effect of POM Juice consumption on carotid intima-media thickness (“CIMT”). (CX0611; see, e.g., CX0029;

CX0280 CX0328/CX0331/CX0337; CX0473 (Compl. Ex. E-2 at 00:24)).

c. A study by Dr. Dean Ornish, published in 2005 titled, Effects of Pomegranate Juice Consumption on Myocardial

Perfusion in Patients with Coronary Heart Disease (“Ornish MP Study”). The Ornish MP Study, examined

the effect of POM Juice consumption on 45 patients with coronary heart disease. (CX1198; see, e.g., CX0351;

CX0355; CX0473 (Compl. Ex. E-2 at 00:30)).

d. A study by Dr. Allan Pantuck, published in 2006 titled, Phase II Study of Pomegranate Juice for Men with

Rising Prostate-Specific Antigen Following Surgery or Radiation for Prostate Cancer (“Pantuck Study”). The
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Pantuck Study examined the effect of POM Juice consumption on 46 men previously treated for prostate cancer by

radiation therapy or surgery. (CX0815; see, e.g., CX0351; CX0355; CX0314 at 0004; CX0372 at 0002; CX0379

at 0002; CX0380 at 0002; CX0473 (Compl. Ex. E-2 at 00:24)).

e. A Study by Dr. C.P. Forest and Dr. H. Padma-Nathan, published in 2007 titled, Efficacy and Safety of

Pomegranate Juice on Improvement of Erectile Dysfunction in Male Patients with Mild to Moderate Erectile

Dysfunction: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study (“Forest/Padma Nathan

Study”). The Forest Erectile Dysfunction Study (2007) examined the effect of POM Juice consumption on 53

men with mild to moderate erectile dysfunction. (CX1193; see, e.g., CX0351; CX0355; CX0473 (Compl. Ex.

E-2 at 00:24)).

127. POM also sponsored a study by Dr. Michael Davidson titled, Effects of Consumption of Pomegranate Juice

on Carotid Intima-Media Thickness in Men and Women at Moderate Risk for Coronary Heart Disease, published

in 2009 (“Davidson CIMT Study”). The Davidson CIMT Study (2009) tested the effect of POM Juice on CIMT

progression rates in 289 subjects at moderate risk for moderate coronary heart disease. (CX1065).

128. In over a decade, Respondents sponsored over 100 studies at 44 different institutions. (Liker, Tr. 1887-88).

129. Of the studies POM had conducted as of 2010, approximately 40 percent were performed at UCLA or by Dr.

Aviram at the Technion Faculty of Medicine. (See CX1241; CX1360 (S. Resnick, Dep. at 113-17)).

130. More than 70 of the studies sponsored by the Respondents have been published in peerreviewed scientific

journals. Seventeen of these published studies are human clinical trials. (Liker, Tr. 1888; CX0611; CX0908;

PX0004; PX0005; PX0014; PX0060; PX0061; PX0020; PX0021; PX0023; PX0073; PX0074; PX0075; PX0127;

PX0136; PX0139; PX0146 (Trombold JR, Barnes JN, Critchley L, and Coyle EF, Ellagitannin Consumption

Improves Strength Recovery 2-3 d after Eccentric Exercise, Med. Sci. Sports Exerc., Vol. 42, No. 3, pp. 493-98,

2010)).

*12 131. Respondents continue to sponsor medical research to determine the benefits of their pomegranate

products. Respondents have invested over 35 million dollars in their research program. (S. Resnick, Tr. 1752,

1861-64; CX1363 (S. Resnick, Coke Dep. at 74)).

132. Respondents currently have ongoing research in the areas of cardiovascular health and prostate health.

(Tupper, Tr. 984-85, 994; PX0014; PX0023; PX0060; PX0061).

2. Advertising process

a. Overview

133. Roll has a full-service internal advertising agency called Fire Station. (JX0001 18; L. Resnick, Tr. 88-89;

Leow, Tr. 493; Perdigao, Tr. 593-94).

134. George Michael Perdigao (“Mr. Perdigao”) is the president of Roll's advertising agency, Fire Station, and

Roll's corporate communications department, and reports to the Resnicks. (CX1376 (S. Resnick, OS Dep. at 145);

JX0001 18; Perdigao, Tr. 590, 594).
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135. Elizabeth Leow Hendry (“Ms. Leow”) has been a creative director at Roll since 2005, with POM as one of

her clients. Ms. Leow is currently the creative director for Fire Station, one of Roll's companies. She has continued

to work on POM's advertising. (Leow, Tr. 415; CX1356 (Leow, Dep. at 16-18, 22)).

136. Prior to Fire Station's creation in approximately January 2008, Roll provided advertising services to its

affiliated companies through advertising personnel employed by Teleflora, another Roll affiliate. (F. 11; Perdigao,

Tr. 592).

137. This group of advertising professionals at Teleflora and later Fire Station has also been known as “The

Agency.” (Perdigao, Tr. 592; L. Resnick, Tr. 88-89).

138. POM uses Fire Station for all or virtually all of its domestic advertisement agency needs. (Tupper, Tr. 920-21).

139. Generally, Fire Station would be responsible for coming up with specific creative ideas or media plans, and

POM's marketing department would help guide the process and provide input. (CX1357 (Kuyoomjian, Dep. at

88-89)).

140. The creation of POM marketing and advertising was a collaborative effort between Fire Station and POM

that entailed coming up with ideas for print, outdoor, or television campaigns, as well as writing copy, creating

graphics, and putting the ideas together for a final execution. (Leow, Tr. 420-21; Tupper, Tr. 920).

b. Development of advertising

141. Mrs. Resnick held regular creative meetings with the senior in-house representatives of POM and Roll,

including representatives of POM's marketing department (“POM Marketing”), Roll's public relations department,

and Roll's advertising agency, Fire Station. Staff members at POM and Roll informally refer to these meetings

with Mrs. Resnick as “LRR Meetings.” (JX0003 A.12; L. Resnick, Tr. 87-88, 92)).

142. In addition to Mrs. Resnick, Mr. Tupper and employees from POM's marketing and scientific departments,

Fire Station employees and someone from Roll's Corporate Communications department regularly attend LRR

meetings. (Rushton, Tr. 1366; Perdigao, Tr. 624-25; Tupper, Tr. 929-30; L. Resnick, Tr. 249; CX1351 (McLaws,

Dep. at 33-34).

*13 143. At LRR Meetings and during other interactions with POM Marketing and Fire Station, Mrs. Resnick

would approve a general direction for POM's advertising and also approved the lion's share of POM's advertising

concepts. (CX1362 at 0008 (L. Resnick, Coke Dep. at 30-31); see also Perdigao, Tr. 604, 628 (agreeing that it is

fair to say that Mrs. Resnick has final authority on advertising campaigns); Rushton, Tr. 1369-71 L. Resnick, Tr.

99-100, 186-87; Leow, Tr. 470; CX0023 at 0001 (stating that “LRR is going to take a more active role in writing

copy[]” and that “[i]f [Mrs. Resnick] writes it, it will be approved”); CX1351 (McLaws, Dep. at 23-24) (stating

that the “decision to either move forward or make adjustments [on marketing on advertising] came from Lynda”)).

144. Mr. Tupper attended most of the LRR Meetings, at which the highest-level executives involved in marketing

discussed how to better market POM's products. (Perdigao, Tr. 624-25).

c. Creative briefs
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145. The first step in the creative process for POM advertising is a “creative brief,” prepared by POM's marketing

department and provided to Fire Station. (L. Resnick, Tr. 123; Loew, Tr. 451; CX1368 at 0024 (L. Resnick, Welch

Dep. at 95)).

146. The creative brief was the document used to formally initiate an advertising project. (Perdigao, Tr. 616-17).

147. A creative brief is an outline of the assignment, with the purpose of providing an overview of the assignment.

A creative brief might include information on the key message(s) to be conveyed, a suggested target audience

for the advertisement, demographics, and media. (Leow, Tr. 451-52; L. Resnick, Tr. 123; see CX0409 (creative

briefs ranging from January 2004 to October 2009); see also CX0129 to CX0131 (2007 creative briefs for POMx

print advertisements)).

148. The creative brief outline addresses matters such as “Objective,” “Target Audience,” “Insights,” “Main

Message,” “Benefit” or “Benefits,” and “Tonality,” among other matters. (CX0409).

149. Creative briefs are developed for new marketing campaigns that POM undertakes. (Tupper, Tr. 921).

150. POM's online marketing department prepares creative briefs for online components of POM's marketing

initiatives. Such briefs are then submitted to Fire Station. (Rushton, Tr. 1353-54, 1391-92).

151. A creative brief is a concept document, to give the advertising agency (Fire Station) insight on how to start a

campaign. The substance of a creative brief may or may not ultimately be reflected in an advertisement. (Tupper,

Tr. 921; Leow, Tr. 484-85).

152. By their nature, creative briefs were brief and general, and there would be one or more follow-up meetings

to discuss the project. (Rushton, Tr. 1396; Perdigao, Tr. 618).

153. The creative process is a collaborative process in which participants share and mold concepts, thoughts and

ideas. “It's not like ... you get a creative brief, a guy goes in a room, and then comes out with an ad. It's not quite

that simple.” (Perdigao, Tr. 621-22).

*14 154. Mr. Tupper participated in discussions with the marketing department about individual parts or elements

of creative briefs. (Tupper, Tr. 924).

155. Once the creative brief was received by Fire Station, it would be assigned to appropriate personnel at the

agency, depending on the project. (Leow, Tr. 452-53).

156. The creative team(s) at Fire Station would then work together to start creating advertisement concepts, which

would be reviewed first by Ms. Leow, then by Mr. Perdigao, and finally by POM Marketing. It is a fluid process,

including multiple revisions. Depending on the assignment, the concepts were sometimes also reviewed by Mr.

Tupper. These reviews at the concept stage involved the general creative direction, look, tone, and idea of the

advertising, rather than body copy. (Leow, Tr. 457-60).

157. Advertising concepts would include the graphics and headlines. A headline is the main message of an

advertisement and usually appears in larger type. Body copy is the smaller print usually appearing at the bottom

of an advertisement. (Leow, Tr. 462-63, 467).
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158. After the creative concepts were approved, the creative team at Fire Station would draft body copy with

direction from POM Marketing, using the creative brief as an outline and including any additional input marketing

might add. (Leow, Tr. 462-64).

159. There are no scientists or technical writers on Fire Station's staff. Therefore, if the body copy of an

advertisement were to contain information on studies and POM Marketing wanted specific wording, it would be

provided by POM Marketing. (Leow, Tr. 464-65).

160. After the copy of an advertisement was drafted, it would go to the head of marketing for approval, and

sometimes, depending on the project, to Mr. Tupper and Mrs. Resnick for approval. (Leow, Tr. 463-64; L. Resnick,

Tr. 187-188).

161. Once the concepts for a big advertising campaign were approved, they would ultimately go to Mrs. Resnick

for approval. Fire Station presented advertising concepts to Mrs. Resnick during LRR Meetings. (Leow, Tr. 461;

Perdigao, Tr. 623-25; Rushton, Tr. 1358).

162. In addition to approving the body copy, POM Marketing would also thereafter provide final review of the

completed advertisement, and depending on the project, Mr. Tupper might approve it as well. (Leow, Tr. 464-66).

163. After proofreading by Fire Station personnel, POM's advertisement would be sent to Fire Station's production

department to create the “mechanical” — the completed advertisement in final electronic form that is ready to be

sent to publications. (Leow, Tr. 466-67).

164. The process POM uses to connect the science to the advertising includes a “checklist of individuals who need

to review and sign off on those ads, ultimately culminating in the legal review.” (Tupper, Tr. 2977-78).

165. POM approves final executions of advertisements created by Fire Station before dissemination. (Leow, Tr.

466; Perdigao, Tr. 637).

*15 166. Mrs. Resnick would sometimes review finished advertisements. (Leow, Tr. 466).

167. Mrs. Resnick's participation in the creative process included briefing POM Marketing, as well as meeting

with POM and Fire Station personnel to review proposed creative pieces developed by Fire Station. (CX1368 at

0003 (L. Resnick, Welch Dep. at 9-10)).

168. Mrs. Resnick has reviewed and provided detailed edits and suggestions for POMx Pill advertisements

(CX0126 at 0002) and the POM Wonderful website (CX0024 at 0009-38); approved designs and headlines for

advertisements in various media (CX0247 at 0002; CX0248 at 0002); and suggested and reviewed concepts for

new advertisements (CX0266 at 0002-03; CX0320 at 0002).

3. Target audience for POM Products advertising

169. The POM Juice print advertisements at issue in this case were disseminated in a wide variety of

locally and nationally distributed publications, including but not limited to: the Chicago Tribune (CX0016),

Prevention (CX0029, CX0034, CX0260), Details (CX0031), Rolling Stone (CX0033, CX0036), Health (CX0103,

CX0251), InStyle (CX0109), Town and Country (CX0109) Men's Health (CX0192, CX0260), and Men's Fitness

(CX0274). See also CX0474; CX0371 (declarations describing capture of print advertisements and dissemination

information).
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170. The POMx Pills print advertisements at issue in this case were disseminated in a wide variety of locally and

nationally distributed publications, including but not limited to: Fortune (CX0120), the New York Times (CX0169,

CX0337), Discover (CX0122), Men's Health (CX0348), Popular Science (CX0348), Time (CX0350) and Playboy

(CX0355, CX0470 at 0002; Leow Tr. 496).

171. The POM Products have been advertised in print advertisements in magazines, freestanding inserts (“FSIs”)

in newspapers, out of home media such as billboards and bus shelters, posters in health clubs and doctors'

offices, advertising on prescription drug bags, Internet websites, online banner advertisements, medical outreach,

radio, television, and press releases. (L. Resnick, Tr. 81-82 (radio), 186 (FSIs); Leow, Tr. 426-28, 457 (out

of home, health clubs, banner ads, television); Perdigao, Tr. 597-98 (press releases), 608-09 (prescription drug

bags); Tupper, Tr. 927 (magazine wraps); CX1375 (L. Resnick, Trop. Dep. at 167 (medical outreach)); CX1357

(Kuyoomjian, Dep. at 85-86 (posters in doctors' offices)), 122 (radio)).

172. POM placed advertising in such magazines as Health Magazine, Men's Health, and Men's Fitness, because

these publications are geared toward the health-conscious consumer. (Leow, Tr. 425-26).

173. POM has purchased online banner advertisements on websites, including specific websites with audiences

interested in personal health, fitness, and physical well-being such as Men's Health, ESPN, Livestrong, and

WebMD. (Rushton, Tr. 1397-98; CX0463; CX0466; CX0468; Leow, Tr. 428-29).

*16 174. Current POM Juice buyers tend to be in their forties, possibly older, and are sophisticated to some

extent about their health. (L. Resnick, Tr. 127-28).

175. For purposes of a creative brief (see F. 145-151) “target audience” refers to the audience to whom the

advertisement would appeal. (Leow, Tr. 451-52).

176. Seven creative briefs for POM Juice advertising projects, dating between January 2004 and July 2006,

described the “target audience” for the subject advertisement as: “Hip Gen X 25-39. Skews female (60/40) likely

to be affluent, professional, college grads who are very health-conscious (hypochondriacs) and live in urban areas.

Either single or married without kids.” (CX409 at 0001; see also CX0409 at 0003, 0005, 0006, 0008, 0010, and

0022). In July 2006, this description was prefaced with the comment, “same as general POM consumer.” (CX409

at 0022)

177. Two creative briefs dated June 28, 2006 and July 13, 2006, which stated that they were to be used for all

future POMx Pill projects, identified the target audience for POMx Pills as “Age and Gender: 25-64 year old men

and women (50/50 split) Psychographic: (1) Core POM Consumer, (2) Consumer who won't drink the juice or tea

but who is seeking a natural cure for current ailments or to maintain health and prevent future ailments[.]” These

creative briefs further noted, under “tonality,” in part, “catchy headlines but serious copy that reflects the fact that

antioxidants are important for health. The pill form is more medicinal by nature and attracts consumers that are

looking for health benefits but won't drink the juice or tea.” (CX0409 at 0016, 0018).

178. A creative brief for POMx Pills, dated September 1, 2006, referred to “a handful of different creative

approaches targeting different consumers that include men, seniors and young health conscious females.” Under

target consumer audience,” this creative brief stated: “Age & Gender: Start with men 40+, HH income $75K+,

primarily men who are scared to get prostate cancer ... Two other targets based on this plan include seniors 55+

who are heavy supplement users (AARP & Readers' Digest) and young health conscious women (Oprah, More,

Health) — both of whom will benefit from the antioxidants (cardiovascular, anti-aging, etc.).” (CX0409 at 0023).
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179. In a creative brief for the “Health Benefits” section of the POM Wonderful website, from June 2008, the

“target audience” was described as “General population (35+, 60% Female): Consumers ... Who are looking

for general information about Pomegranate Health, Antioxidant, Polyphenol or related topics and want to learn

more ... or find out the truth about Pomegranates[,] Who have seen articles about pomegranates or antioxidants [,]

With an ailment that pomegranates have been rumored to help[.]” The “target audience” for the website was also

identified to include “Health Care Professionals” including “Primary care physicians[,] Urologists[,] Dieticians

[,] Nutritionalists[,] Other healthcare industry professionals.” (CX0200 at 0002).

*17 180. Ms. Leow, a creative director for Roll, expressed her opinion that scientific information in advertising

and marketing material helps sell the products, because the scientific information provides the consumer with a

“reason to believe.” (Leow, Tr. 512-13).

181. A creative brief attached to an email from Michael Perdigao to Lynda Resnick dated June 25, 2008, noted that

the “primary target consumer” for an unidentified referenced POM Juice campaign “should be the 30-something

health conscious (hypochondriac?) who is educated and affluent.” (CX0211 at 0002).

D. Testifying Experts

1. Complaint Counsel's experts

a. Dr. Meir Stampfer

182. Dr. Meir J. Stampfer is a Professor of Epidemiology and Nutrition, Harvard School of Public Health; Faculty

Member, Division of Biological Sciences, Harvard School of Public Health; Professor of Medicine, Harvard

Medical School; and Faculty Member, Dana Farber Harvard Cancer Center. (Stampfer, Tr. 689-91; CX1293

(Stampfer Expert Report at 0001)). He teaches epidemiology, advanced epidemiology, and preventive medicine.

(CX1293 (Stampfer Expert Report at 0001)). Epidemiology is the study of the determination and distribution of

disease in humans. (Stampfer, Tr. 691).

183. Dr. Stampfer has been an investigator in several large studies focused on the relationship between nutrition

and cancer and cardiovascular disease (“CVD”), and their precursors. (CX1293 (Stampfer Expert Report at

0003-04)). These include: Nurses' Health Study (started 1976, 121,700 women, cancer prevention, CVD, diabetes,

and other health issues); Nurses' Health Study II (started 1989, 116,800 women, same as Nurses' Health Study);

Physicians' Health Study (started 1982, 29,000 men, multivitamin supplements, and aspirin, and beta carotene for

prevention of CVD and cancer); and Health Professionals Follow-up Study (started 1986, 51,529 men, nutritional

factors as related to cancer, including prostate cancer, and heart disease). (CX1293 (Stampfer Expert Report at

0003-04); Stampfer, Tr. 692-94). Additionally, he has participated in research investigating risk factors (including

food intake and dietary factors) associated with prostate cancer and conducted randomized clinical trials involving

nutrition and health, including dietary interventions to reverse atherosclerosis. (Stampfer, Tr. 698-700).

184. Dr. Stampfer has published more than 850 articles in medical journals, including the New England Journal

of Medicine, American Journal of Epidemiology, Epidemiology, and Journal of American Medical Association.

(CX1293 (Stampfer Expert Report at 0002)). Over 300 of these articles relate to the relationship between nutrition

and the prevention or treatment of CVD or prostate cancer. (Stampfer, Tr. 701; see also CX1293 (Stampfer Expert

Report at 0002)).

185. In 2003, the Institute for Scientific Information identified Dr. Stampfer as the most cited researcher in clinical

medicine and epidemiology in the world during the past 20 years. (CX1293 (Stampfer Expert Report at 0002)).
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In 2005, the Institute for Scientific Information identified him as the most cited researcher in clinical medicine

over the previous decade. (CX1293 (Stampfer Expert Report at 0002)).

*18 186. Dr. Stampfer currently is an editor for leading medical journals, including the Journal of the American

College of Nutrition, American Journal of Epidemiology, American Journal of Medicine, and Clinical Chemistry.

Dr. Stampfer also had editorial positions on the American Journal of Clinical Nutrition, New England Journal of

Medicine, and American Journal of Medicine. (Stampfer, Tr. 701; CX1293 (Stampfer Expert Report at 0001-02)).

Dr. Stampfer is a member of professional organizations relating to epidemiology, cancer, and CVD, including the

Society of Epidemiological Research, the American College of Nutrition, the American Heart Association, and

the American Association for Cancer Research. (Stampfer, Tr. 701-03). He also has consulted for the government

on the U.S. Dietary Guidelines. (Stampfer, Tr. 703).

187. Dr. Stampfer was accepted as an expert on: 1) epidemiology; 2) nutrition, including its relation to the

prevention and treatment of CVD and prostate cancer; and 3) clinical testing related to the prevention of prostate

cancer and CVD. (Stampfer, Tr. 704-05; see also CX1293 (Stampfer Expert Report at 0005)).

188. Dr. Stampfer was asked to evaluate, from his perspective as an expert in the fields of epidemiology, nutrition,

and clinical testing, whether the following claims were supported by the materials submitted by the Respondents:

• drinking eight ounces of POM Juice, or taking one POMx Pill or one teaspoon of POMx Liquid, daily, treats,

prevents, or reduces the risk of heart disease, including by decreasing arterial plaque, lowering blood pressure,

and/or improving blood flow to the heart;

• tests prove that drinking eight ounces of POM Juice or taking one POMx Pill or one teaspoon of POMx Liquid,

daily, treats, prevents, or reduces the risk of heart disease, including by decreasing arterial plaque, lowering blood

pressure, and/or improving blood flow to the heart;

• drinking eight ounces of POM Juice, or taking one POMx Pill or one teaspoon of POMx Liquid, daily, treats,

prevents, or reduces the risk of prostate cancer, including by prolonging prostate-specific antigen doubling time

(“PSADT”); and

• tests prove that drinking eight ounces of POM Juice, or taking one POMx Pill or one teaspoon of POMx Liquid,

daily, treats, prevents, or reduces the risk of prostate cancer, including by prolonging “PSADT.”

(CX1293 (Stampfer Expert Report at 0005-06)).

189. To form his opinions, in addition to drawing upon his own expertise, Dr. Stampfer reviewed materials

submitted by Respondents and affiliated researchers, including published and unpublished study reports,

protocols, data and data analyses from Respondents' sponsored research, information about ingredients contained

in the POM Products, and deposition transcripts of researchers who conducted studies for Respondents and related

deposition exhibits and reports. Dr. Stampfer also reviewed materials he found through his independent literature

search. (CX1293 (Stampfer Expert Report at 0006-07); Stampfer, Tr. 734-36; CX1294).

*19 190. Dr. Stampfer opined that the materials relied upon by Respondents do not provide competent and

reliable scientific evidence to support claims that: (1) drinking eight ounces of POM Juice or taking a daily serving

of POMx is clinically proven to treat, prevent, or reduce the risk of heart disease or prostate cancer; (2) a daily

eight ounce serving of POM Juice or a serving of POMx treats, prevents, or reduces the risk of heart diseases,

including by prolonging PSADT (defined infra F.1042); or (3) a daily eight ounce serving of POM Juice or a
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serving of POMx treats, prevents, or reduces the risk of heart disease, including by decreasing arterial plaque,

lowering blood pressure, and/or improving blood flow to the heart. (CX1293 (Stampfer Expert Report at 0007)).

b. Dr. Frank Sacks

191. Dr. Frank M. Sacks is a Professor of Cardiovascular Disease Prevention, Department of Nutrition, Harvard

School of Public Health, and Professor of Medicine, Harvard Medical School. (Sacks, Tr. 1411-12; CX1291

(Sacks Expert Report at 0001)). He has taught pharmacology, epidemiology, and nutrition courses related to

human disease, CVD, biochemistry, or preventative medicine. (Sacks, Tr. 1412-13; CX1291 (Sacks Expert Report

at 0002)).

192. Dr. Sacks has researched CVD and coronary heart disease (“CHD”) and their risk factors, including

lipid profiles, hypertension, obesity, and diabetes, and the effects of potential risk-modifying diets, foods, food

components, and drugs. (CX1291 (Sacks Expert Report at 0002); Sacks, Tr. 1415-18). He is the principal

investigator of several National Institute of Health studies focusing on dietary nutrients and weight loss,

carbohydrate amount and type affecting risk of CVD and diabetes, and dietary fat and high-density lipoprotein

(“HDL”) metabolism in humans. (CX1291 (Sacks Expert Report at 0005-06)).

193. Dr. Sacks has published more than 160 articles in peer-reviewed scientific journals relating to CVD, CHD,

and the relationship between nutrition and these diseases. (Sacks, Tr. 1412-13, 1424-25; CX1291 (Sacks Expert

Report at 0002-04)). Dr. Sacks has also written over 60 reviews, reports, editorials, and book chapters, addressing

CVD, CHD, and the relationship between nutrition and these diseases or their risk factors. (CX1291 (Sacks Expert

Report at 0004)).

194. Through his professional memberships and activities, Dr. Sacks keeps current on new developments and

research in the areas of nutrition, CVD, cholesterol disorders, and hypertension. (Sacks, Tr. 1424). He served as an

editor for the American Journal of Clinical Nutrition, Journal of Clinical Lipidology, a Nutrition Journal (BioMed

Central), and The Journal of Lipid Research. (CX1291 (Sacks Expert Report at 0006)). In these positions, he

reviewed the adequacy of the design, the conduct of clinical research, and the appropriateness and accuracy of

the statistical methodology in hundreds of papers submitted for publication. (Sacks, Tr. 1424-25; CX1291 (Sacks

Expert Report at 0006)).

*20 195. Dr. Sacks serves as a chair of the Nutrition Committee of the American Heart Association (AHA),

which advises the AHA on matters of science and public policy and devises guidelines and advisory statements

to the government, health professionals, and the public on nutrition. (Sacks, Tr. 1426; CX1291 (Sacks Expert

Report at 0006-07)). Dr. Sacks is also a member of the National Cholesterol Education Program of the National

Heart, Lung and Blood Institute of NIH, which revises national guidelines on prevention and treatment of CVD.

(CX1291 (Sacks Expert Report at 0007); Sacks, Tr. 1426).

196. Dr. Sacks was accepted as an expert in the areas of nutrition, CVD, CHD, cholesterol disorders, hypertension,

and analysis of clinical studies. (Sacks, Tr. 1429-30; CX1291 (Sacks Expert Report at 0008)).

197. Dr. Sacks was asked to determine whether the materials he reviewed were sufficient to support claims that:

(1) drinking eight ounces of POM Juice, or taking one POMx Pill, or one teaspoon of POMx Liquid, daily, treats,

prevents, or reduces the risk of heart disease, including by decreasing arterial plaque, lowering blood pressure, and/

or improving blood flow to the heart; and (2) clinical studies, trials, and/or tests prove that drinking eight ounces

of POM Juice, or taking one POMx Pill, or one teaspoon of POMx Liquid, daily, treats, prevents, or reduces the

risk of heart disease. (CX1291 (Sacks Expert Report 0008-09)).
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198. To form his opinions, in addition to drawing upon his own expertise in nutrition and CVD treatment,

Dr. Sacks reviewed materials submitted by Respondents and affiliated researchers, including published and

unpublished study reports, protocols, data, and data analysis from Respondents' sponsored research, information

about ingredients contained in the POM Products, and deposition transcripts of researchers who conducted

studies for Respondents and related deposition exhibits. Dr. Sacks also reviewed materials he found through an

independent literature search. (Sacks, Tr. 1447-49; CX1291 (Sacks Expert Report at 0008-09); CX1292, Apps.

2, 3, 4).

199. Dr. Sacks opined that: (1) the materials relied upon by Respondents do not support claims that drinking eight

ounces of POM Juice or taking one POMx Pill or one teaspoon of POMx Liquid, daily, prevents, reduces the

risk of, or treats heart disease, including by decreasing arterial plaque, lowering blood pressure and/or improving

blood flow to the heart; and (2) clinical studies, research, and/or trials do not prove that drinking eight ounces

of POM Juice or taking one POMx Pill or one teaspoon of POMx liquid, daily, prevents or reduces the risk of

or treats heart disease, including by, decreasing arterial plaque, lowering blood pressure and/or improving blood

flow to the heart. (CX1291 (Sacks Expert Report at 0010)).

c. Dr. James Eastham

200. Dr. James A. Eastham is the Chief of Urology in the Department of Surgery at Memorial Sloan-Kettering

Cancer Center in New York. He serves as the Director of Clinical Research, Urology and chairs the protocol

review committee for clinical trials in the Department of Surgery. (CX1287 (Eastham Expert Report at 0001);

Eastham, Tr. 1207-08). He is a board-certified urological surgeon who has treated more than 2,000 patients with

prostate cancer, including some who experienced a rise in prostate-specific antigen (“PSA”) after receiving initial

therapy. (CX1287 (Eastham Expert Report at 0002); Eastham, Tr. 1206, 1225-28, 1233).

*21 201. Dr. Eastham has extensive experience, including as an investigator, in the design and conduct of clinical

trials studying prostate cancer. (Eastham, Tr. 1215-17). As a member of the Data Safety Monitoring Board for

the Selenium and Vitamin E Cancer Prevention Trial, he is familiar with the design and performance of the

largest prevention trials studying antioxidants and prostate cancer. (CX1287 (Eastham Expert Report at 0002-03);

Eastham, Tr. 1210-11).

202. Dr. Eastham is a member of several professional associations, including the American Urological

Association, the Society of Urologic Oncology, and the National Comprehensive Cancer Network (“NCCN”)

Prostate Cancer Guidelines Committee. He regularly attends and speaks at national and international meetings of

professional societies that specialize in urology and prostate cancer. (CX1287 (Eastham Expert Report at 0003);

Eastham, Tr. 1211-13).

203. Dr. Eastham has peer-reviewed numerous papers involving randomized, doubleblinded, controlled human

clinical studies that were submitted to medical journals, such as Urology, Journal of Urology, and Journal of

Clinical Oncology. (CX1287 (Eastham Expert Report at 0003); Eastham, Tr. 1224-25). Dr. Eastham has published

over 200 peer-reviewed articles in scientific journals, as well as dozens of book chapters or reviews pertaining

to urology and the treatment of prostate cancer. (CX1287 (Eastham Expert Report at 0003-04); CX1288, Ex. A;

Eastham, Tr. 1214-15).

204. Dr. Eastham was accepted as an expert in the areas of: (1) urology specializing in prostate cancer, including

the prevention and treatment of prostate cancer; and (2) clinical testing related to the prevention and treatment of

prostate cancer. (Eastham, Tr. 1234; CX1287 (Eastham Expert Report at 0004)).
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205. Dr. Eastham was asked to determine whether the materials he reviewed were sufficient to support claims

that: (1) drinking eight ounces of POM Juice, or taking one POMx Pill, or one teaspoon of POMx Liquid, daily,

treats, prevents, or reduces the risk of prostate cancer, including by prolonging prostate-specific antigen doubling

time (“PSADT”); and (2) tests prove that drinking eight ounces of POM Juice, or taking one POMx Pill, or one

teaspoon of POMx Liquid, daily, treats or prevents prostate cancer, including by prolonging PSADT. (CX1287

(Eastham Expert Report at 0004-05)).

206. To form his opinions in addition to drawing upon his own expertise in the field of urology, specializing

in prostate cancer, including the prevention and treatment of prostate cancer, and clinical testing relating to the

treatment and prevention of prostate cancer, Dr. Eastham reviewed the materials submitted by Respondents and

affiliated researchers, including published and unpublished study reports, protocols, data and data analysis from

Respondents' sponsored research, and information about ingredients contained in the POM Products. Dr. Eastham

also reviewed materials he found through an independent literature search. (CX1287 (Eastham Expert Report at

005); Eastham, Tr. 1287-88; CX1288, Ex. B).

*22 207. Dr. Eastham provided the following opinion: the materials relied upon by Respondents do not provide

reliable scientific evidence that POM Juice, POMx Pills, or POMx Liquid effectively prevents, reduces the risk

of, or treats prostate cancer or are clinically proven to do so. (CX1287 (Eastham Expert Report at 006, 012)).

d. Dr. Arnold Melman

208. Dr. Arnold Melman is a Professor and Chairman of the Department of Urology at Albert Einstein College of

Medicine and Montefiore Medical Center in New York. (Melman, Tr. 1072-73). Dr. Melman is a board-certified,

practicing clinical urologist at Montefiore Medical Center and has treated thousands of patients with erectile

dysfunction. (Melman, Tr. 1071-73).

209. Dr. Melman has extensive experience in designing and reviewing protocols for well-designed clinical trials.

As an editor of Sexuality and Disability, the Journal of Urology, and the International Journal of Impotence

Research, Dr. Melman reviewed hundreds of articles involving erectile dysfunction by evaluating, among other

factors, the design, data collection and reporting, and statistical analysis of clinical studies. (Melman, Tr. 1075-77;

CX1289 (Melman Expert Report at 0002)). Furthermore, Dr. Melman was a principal investigator on two National

Institutes of Health research grants relating to erectile dysfunction. (Melman, Tr. 1079-80; CX1289 (Melman

Expert Report at 0002-03)).

210. Dr. Melman was chairman of the U.S. Food and Drug Administration's Gastroenterology and Urology

Devices Panel of the Medical Devices Advisory Committee, and was a member of the National Institutes of

Health's Urology Special Emphasis Panel. (Melman, Tr. 1077-78; CX1289 (Melman Expert Report at 0001-02)).

Dr. Melman is a member of several professional organizations, including the American Federation for Clinical

Research, Society of University Urologists, American Urological Association, American Association of Clinical

Urologists, International Society of Urology, and International Academy of Sex Research; and has spoken at

national and international meetings of professional societies that specialize in urology and erectile dysfunction.

(Melman, Tr. 1077-79; CX1289 (Melman Expert Report at 0001-02)). Dr. Melman has published more than 200

peer-reviewed articles relating to urology in scientific journals. Many of these published articles relate to erectile

dysfunction. (Melman, Tr. 1076-77; CX1289 (Melman Expert Report at 0002)).

211. Dr. Melman was accepted as an expert in: (1) urology as it relates to the treatment, prevention, and reduction

of risk of erectile dysfunction; and (2) clinical testing involving erectile dysfunction. (Melman, Tr. 1080-81).
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212. Dr. Melman was asked to determine whether the materials he reviewed were sufficient to support claims that:

(1) drinking eight ounces of POM Juice, daily, prevents, reduces the risk of, or treats erectile dysfunction; and (2)

clinical studies, research, and/or trials prove that drinking eight ounces of POM Juice, daily, prevents, reduces the

risk of, or treats erectile dysfunction. (CX1289 (Melman Expert Report at 0003)).

*23 213. To form his opinions, in addition to relying on his expertise in urology as it relates to the treatment,

prevention, and reduction of risk of erectile dysfunction, and clinical testing involving erectile dysfunction,

Dr. Melman reviewed materials submitted by Respondents and affiliated researchers, including published and

unpublished study reports, protocols, and data and data analyses from Respondents' sponsored research. (CX1289

(Melman Expert Report at 0003); Melman, Tr. 1083). Dr. Melman also reviewed articles he found through his

independent research of peer-reviewed journals. (Melman, Tr. 1083; CX1289 (Melman Expert Report at 0003)).

214. Dr. Melman opined that POM Wonderful pomegranate juice has not been proven to prevent, reduce the risk

of, or treat erectile dysfunction. (CX1289 (Melman Expert Report at 0005)).

2. Respondents' experts

a. Dr. Denis Miller

215. Dr. Denis R. Miller is a board certified pediatrician and pediatric hematologist and oncologist licensed to

practice medicine in the state of New Jersey. (PX0206 (Miller Expert Report at 1); PX0354 (Miller, Dep. at 16)).

He directs one of the largest pediatric oncology/ hematology programs in the world and holds an endowed chair.

(PX0206 (Miller Expert Report at 3)).

216. Dr. Miller has, for over 40 years, directed clinical care, education, laboratory and clinical research, and

administration, and led departments at some of the most prestigious hospitals in the world. (PX0206 (Miller Expert

Report at 2); Miller, Tr. 2190). Dr. Miller has designed, managed, and directed many different research studies

calculated to develop new anti-cancer agents. (PX0206 (Miller Expert Report at 2-3)).

217. Dr. Miller has authored or co-authored over 300 book chapters, peer-reviewed articles, and abstracts mostly

on cancer and blood disorders. (PX0206 (Miller Expert Report at 4); Miller, Tr. 2191).

218. Complaint Counsel has retained Dr. Miller on several matters, and he testified for Complaint Counsel

previously in the matter of Daniel Chapter One. (PX0206 (Miller Expert Report at 5, 18)).

219. Dr. Miller was accepted as an expert in the design of clinical research protocols and asked to testify on the

areas of the applicable standards of substantiating evidence for fruit and fruit juice or food products in general as

opposed to the standard that is applicable to drugs. (Miller, Tr. 2192, 2218).

220. Dr. Miller provided the following opinions: pomegranates are a food that have been eaten for thousands

of years and its consumption as a food is without known risks; the appropriate level of scientific substantiation

regarding the health benefit claims of pomegranates should be flexible and consider several factors (including risk

of harm) with the desirability of getting information to the public; the standard for substantiating foods that are

clearly safe need not be as rigorous as that for a new drug or anticancer agent, but should be based on reliable and

competent scientific data; and POM Wonderful is not being put forth as a substitute or alternative to conventional

and approved drug therapies and medical care. (PX0206 (Miller Expert Report at 15)).
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b. Dr. David Heber

*24 221. Dr. David Heber received his Ph.D. in Physiology from UCLA, an MD from Harvard Medical School,

and a B.S. in Chemistry from UCLA. (PX0192 (Heber Expert Report at 0005)). Dr. Heber is the founding director

of the UCLA Center for Human Nutrition, which is a center for clinical research, education, and public health

endeavors. (Heber, Tr. 1937).

222. Dr. Heber is a treating physician with patients, and has been a member of the faculty of UCLA Medical

School for 33 years. He is currently a Professor of Medicine in Public Health. (Heber, Tr. 1937; CX1407 (Heber,

Tropicana Tr. 76)).

223. Dr. Heber has co-authored over 200 peer-reviewed publications in the field of nutrition and its relation to

various diseases and written 25 chapters in other scientific texts. (Heber, Tr. 1939-40). He was the editor-in-chief

of the leading text on nutritional oncology and has written a book on the importance of diet in maintaining health

and resisting diseases. (Heber, Tr. 1939).

224. Dr. Heber was accepted as an expert in the relationship between nutrition and various diseases, including

coronary heart disease and prostate cancer, as well as other diseases. (Heber, Tr. 1941).

225. Dr. Heber was asked to testify on Dr. Stampfer's expert report and provide opinions on issues related to

pomegranate juice and extract, including: (1) antioxidants found in pomegranates, their potency, and how they act

in the body (their mechanisms of action); (2) the health and safety effects; and (3) nutritional research methodology

relating to the evaluation of scientific research on health benefits. (PX0192 (Heber Expert Report at 0004)).

226. Dr. Heber provided the following opinions: it is not appropriate to require the use of double-blind placebocontrolled studies for evaluating the health benefits of foods; translational nutritional science looks at the best

available evidence, as a totality, rather than just one type of clinical study; and the body of research on pomegranate

juice and extract, revealing how they act in the body, provides support for potential benefits for heart disease and

prostate cancer. (PX0192 (Heber Expert Report at 0013-15)).

c. Dr. Dean Ornish

227. Dr. Dean Ornish is a medical doctor and Clinical Professor of Medicine at the University of California at

San Francisco. (Ornish, Tr. 2314).

228. Dr. Dean Ornish is the Founder and President of the Preventative Medicine Research Institute (“PMRI”) in

Sausalito, CA. (PX0025 (Ornish Expert Report at 0001)).

229. For over 34 years, Dr. Ornish directed clinical research on the relationship between diet and lifestyle and

coronary heart disease. He was the first to prove by a series of RCTs that heart disease could be reversed by

making changes in diet and lifestyle. (Ornish, Tr. 2316-17).

230. Dr. Ornish has written six published books on the subject of the effect of diet and lifestyle on heart disease

and other diseases. (Ornish, Tr. 2318). Dr. Ornish's research has been reported in many prestigious journals, and

he has written numerous articles for distinguished peer-reviewed journals. (Ornish, Tr. 2318-19).
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*25 231. Dr. Ornish was accepted as an expert in the relationship between the heart and nutrition and in

cardiovascular disease and its relationship to nutrition and nutrients. (Ornish, Tr. 2321-22).

232. Dr. Ornish was asked to evaluate: (1) whether drinking eight ounces of POM Juice or taking one POMx

Pill or one teaspoon of POMx Liquid may be beneficial in maintaining cardiovascular health and lessening the

risk of cardiovascular disease; and (2) whether basic science, clinical studies, research, and/or trials show that the

consumption of POM Juice, POMx Pill, or POMx Liquid may be beneficial in maintaining cardiovascular health

and lessening the risk of cardiovascular disease. Dr. Ornish was further asked to review the report titled, “Expert

Report of Frank M. Sacks” and to evaluate the claims and statements made in that document. (PX0025 (Ornish

Expert Report at 0004-05)).

233. Dr. Ornish provided the following opinion: the scientific evidence from basic science studies, animal research,

and clinical trials in humans indicates that pomegranate juice in its various forms (including POM Wonderful

100% Pomegranate Juice, POMx Pill, or POMx Liquid) is likely to be beneficial in maintaining cardiovascular

health and is likely to reduce the risk of cardiovascular disease. (PX0025 (Ornish Expert Report at 0005)).

d. Dr. Arthur Burnett

234. Dr. Arthur Burnett is a Professor of Urology serving on the faculty of the Department of Urology at the

Johns Hopkins University School of Medicine/Johns Hopkins Hospital. (PX0149 (Burnett Expert Report at 0001);

Burnett, Tr. 2241). Dr. Burnett holds a faculty appointment in the Cellular and Molecular Medicine Training

Program of the Johns Hopkins University School of Medicine and is the Director of the Basic Science Laboratory

in Neuro-urology of the James Buchanan Brady Urological Institute and Director of the Male Consultation Clinic/

Sexual Medicine Division of the Department of Urology at Johns Hopkins. (PX0149 (Burnett Expert Report at

0001); Burnett, Tr. 2241).

235. Dr. Burnett obtained his medical degree from the Johns Hopkins University School of Medicine in Baltimore,

Maryland and completed his internship, residency and fellowship at the Johns Hopkins Hospital. (PX0149 (Burnett

Expert Report at 0001); Burnett, Tr. 2240-41).

236. Dr. Burnett has authored and published over 180 original peer-reviewed articles and 40 book chapters.

(PX0149 (Burnett Expert Report at 0003)).

237. Dr. Burnett has treated between 10,000 and 15,000 patients for erectile dysfunction. (Burnett, Tr. 2244).

238. Dr. Burnett has conducted world renowned research on nitric oxide (“NO”). (PX0149 (Burnett Expert Report

at 0003)).

239. Dr. Burnett was accepted as an expert in the field of urology and sexual medicine to offer opinions on: (1)

the science of nitric oxide biology; (2) the mechanisms by which nitric oxide is formed and acts in penile erection

and in the promotion of erectile health, erectile function and treatment of erectile dysfunction; (3) the impact of

pomegranate juice and antioxidants and nitric oxide on erectile health, erectile function and erectile dysfunction;

and (4) scientific studies involving erectile function and dysfunction. (PX0149 (Burnett Expert Report at 0001-07);

Burnett, Tr. 2243-44, 2249-51, 2255-56, 2270-74; PX0349 (Burnett, Dep. at 23-25, 103, 112, 116-118, 137)).

*26 240. Dr. Burnett was asked to provide expert testimony regarding POM's basic science and clinical study, as

well as pomegranate juice's effect on the nitric oxide regulatory mechanism, the vascular system/function, and on
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erectile health, erectile function and erectile dysfunction. (PX0149 (Burnett Expert Report at 0004-07); PX0349

(Burnett, Dep. at 103, 112, 116-118); Burnett, Tr. 2243-44, 2255-56, 2270-74).

241. To form his opinions, Dr. Burnett reviewed studies on erectile function and nitric oxide, including POMsponsored studies such as the Forest Erectile Dysfunction Study (2007) and a few in vitro and animal studies.

(PX0149 (Burnett Expert Report at 0004)). Dr. Burnett relied upon his “education, experience, and knowledge

of developments in the fields of urology and sexual medicine, including the promotion of erectile health and

treatment of erectile dysfunction.” (PX0149 (Burnett Expert Report at 0004)).

242. Dr. Burnett provided the following opinion: pomegranate juice possesses potent antioxidative endothelial

NO mechanisms in vasculature. These mechanisms serve potential beneficial effects on vascular blood flow

and promote vascular biologic health. Basic scientific and clinical evidence supports the probable benefit of

pomegranate juice on the vascular structures involved in penile erection. (PX0149 (Burnett Expert Report at

0005-06)).

e. Dr. Irwin Goldstein

243. Dr. Irwin Goldstein is a sexual medicine physician who has been practicing medicine since 1976 and has been

involved in sexual medicine clinical practice, clinical research and basic science research since 1980. (PX0189

(Goldstein Expert Report at 0001-02); PX0352 (Goldstein, Dep. at 14)).

244. Dr. Goldstein has been certified by the American Board of Urology since 1982. He was a Professor of Urology

and Professor of Gynecology at the Boston University School of Medicine from 1990 to 2005 and 2002 to 2005,

respectively. (PX0189 (Goldstein Expert Report at 0001-03)).

245. Dr. Goldstein has published over 250 original peer-reviewed manuscripts in male and female sexual medicine.

(PX0189 (Goldstein Expert Report at 0002-03)).

246. Dr. Goldstein was part of the original advisory board to Pfizer that engaged in an extensive drug development

plan that developed sildenafil (Viagra), and was also on the advisory boards of Bayer and Eli Lilly for the

development of vardenafil (Levitra) and tadalafil (Cialis). (Goldstein, Tr. 2590-91).

247. Dr. Goldstein was accepted as an expert in the field of sexual medicine, the studies that have been done

on sexual medicine and the impact of pomegranate juice and antioxidants and nitric oxide on erectile function

and dysfunction. (Goldstein, Tr. 2592). Dr. Goldstein was asked to provide testimony on: (1) sexual medicine;

(2) the study, design, and treatment of men with sexual health problems; (3) the studies that have been done on

sexual medicine particularly regarding the promotion of erectile health and treatment of erectile dysfunction; (4)

the mechanisms by which nitric oxide is formed and acts in penile erection and in the promotion of erectile health

and treatment of erectile dysfunction; (5) urology as it relates to the treatment, prevention, and reduction of risk

of erectile dysfunction; (6) the impact of pomegranate juice and antioxidants and nitric oxide on erectile health,

erectile function and erectile dysfunction; and (7) scientific testing involving erectile health, erectile function and

erectile dysfunction. (PX0352 (Goldstein, Dep. at 19-22, 37-42); PX0189 (Goldstein Expert Report at 0003-15);

Goldstein, Tr. 2592, 2600-05, 2611, 2620).

*27 248. To form his opinions, Dr. Goldstein reviewed studies on erectile function, nitric oxide, and the

Mediterranean diet, including POM-sponsored studies such as the Forest Erectile Dysfunction Study (2007), an

article titled, Recreational Use of Phsphodiesterase Type 5 Inhibitors by Healthy Young Men (2010), and several

in vitro and animal studies. (PX0189 (Goldstein Expert Report at 0005); PX0352 (Goldstein, Dep. at 125)).
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249. Dr. Goldstein offered the following opinions: (1) the available body of scientific literature, including in vitro,

and preliminary clinical trials, strongly suggests that consuming pomegranate juice promotes erectile health; and

(2) the use of pomegranate juice to promote erectile health is a separate and distinct concept from the use of a

neutraceutical as a safe and effective treatment for the medical condition of erectile dysfunction such as with a

PDE5 inhibitor. (PX0189 (Goldstein Expert Report at 0004-05)). Dr. Goldstein concluded that reasonable and

competent scientific evidence shows that pomegranate produced a definite benefit to proper and effective erectile

function. (Goldstein, Tr. 2605).

f. Dr. Jean deKernion

250. Dr. Jean deKernion is a practicing urologist certified by both the American Board of Surgery and the

American Board of Urology. He obtained his medical degree in 1965 from Louisiana State University School of

Medicine in New Orleans, Louisiana and did his residencies in surgery and urology at the university hospitals of

Cleveland and the National Cancer Institute. (deKernion, Tr. 3039-40, 3127; PX0161 (deKernion Expert Report)).

251. Dr. deKernion was, from 1981 until his retirement in 2011, Chairman of the Department of Urology and

Senior Associate Dean for Clinical Affairs (2001-2011) at the David Geffen UCLA School of Medicine. Dr.

deKernion's responsibilities included the urological clinical and research education of students, residents, and

fellows at all levels; a busy practice in urologic oncology, primarily related to prostate cancer but also bladder and

kidney cancer; growth and oversight of large and diverse research programs; and administration of programs for

the Dean's office and hospital. (deKernion, Tr. 3039; PX0161 (deKernion Expert Report at 0001)).

252. During Dr. deKernion's tenure as Chair of the Department of Urology at UCLA, he built a multidisciplinary

research portfolio, which ranks among the largest and best in the United States. (PX0161 (deKernion Expert

Report at 0003)).

253. Dr. deKernion's career in urologic oncology has involved both clinical and basic/translational research.

(PX0161 deKernion Expert Report at 0001)).

254. Dr. deKernion co-authored the first book on urologic oncology and has co-authored 133 chapters since. His

research has involved both basic laboratory research and clinical research publishing 228 papers to date in peerreviewed journals and many other invited manuscripts. For six years, Dr. deKernion was the associate editor of

the Journal of Urology and has been a reviewer for approximately 20 other peer-reviewed journals. (PX0161

(deKernion Expert Report at 0002); deKernion, Tr. 3041-43).

*28 255. Dr. deKernion has served on a number of national committees and was a founding member of the

Society of Urologic Oncology, was elected as a trustee of the American Board of Urology, and numerous

committees of national urological societies and was appointed to the National Cancer Advisory board by President

Bush. (deKernion, Tr. 3040; PX0161 (deKernion Expert Report at 0002)).

256. Dr. DeKernion was accepted as an expert in the field of urology and prostate health to offer opinions on

research done on pomegranate juice and POM Products as they relate to the prostrate. He was also asked to provide

expert opinions on the validity of PSA doubling time in assessing response to POM Products and on the strength

of the science supporting the role of POM in prostate health and prostate cancer. In addition, Respondents asked

Dr. DeKernion to rebut the opinions in Dr. Eastham's expert report. (deKernion, Tr. 3043-44; 3108-09; PX0161

(deKernion Expert Report at 0003)).
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257. To form his opinions, Dr. deKernion reviewed the expert reports of Dr. Eastham and Dr. Miller, the FTC

depositions of Dr. Pantuck and Dr. Carducci, protocols for the Pantuck Phase II Prostate Cancer Study (2006), the

Carducci Dose Study, and the Pantuck Phase III Study, articles cited in Dr. Eastham's report, scientific articles

found by conducting a literature search, and marketing materials. (PX0351 (deKernion, Dep. at 6-8, 27-29);

PX0351a04; PX0351a05).

258. Dr. de Kernion provided the following opinions: (1) based on the data available, it is reasonable to state

that POM products have shown an effect on prostate cancer with little or minimal toxicity; (2) given the current

evidence, Dr. deKernion would suggest to patients and friends who have early prostate cancer that they consider

taking POM, among other measures such as exercise, restrict intake of fatty foods, and weight control, to improve

their probability for prevention or control of a tumor. (PX0161 (deKernion Expert Report at 0011-12)).

g. Dr. Ronald Butters

259. Dr. Ronald Butters is Professor Emeritus at Duke University and has been on faculty at Duke for over 40

years. He served as the Chairman of the Linguistics Department at Duke and Chairman of Duke University's

English Department. (Butters, Tr. 2812).

260. Dr. Butters is a member of the advisory board of the New Oxford American Dictionary and has served as

editor and co-editor of multiple prestigious scientific and academic publications. He participates in numerous

professional associations and is the past president of the International Association of Forensic Linguistics. (Butters,

Tr. 2812-13).

261. Dr. Butters has written textbooks and other books on the subjects of linguistics, which is the study of all

forms of human language: semantics and semiotics. (Butters, Tr. 2814-15).

262. Dr. Butters was accepted as an expert in linguistics, including the meaning of language and symbols and the

context in which they appear. (Butters, Tr. 2816, 2954-55).

*29 263. Dr. Butters offered his opinions as a linguistics expert on the meanings of Respondents' advertisements.

(Butters, Tr. 2816-17).

264. Dr. Butters concluded that Respondents' advertisements do not convey, either expressly or by implication:

that scientific research proves that the use of certain recommended amounts, in recommended frequencies, of Pom

Wonderful products successfully treats, prevents, or reduces: (1) the risk of heart disease, including decreasing

arterial plaque, lowering blood pressure, and/ or improving blood flow to the heart; (2) the risk of prostate

cancer, including by prolonging prostate-specific antigen doubling time (“PSADT”); and (3) the risk of erectile

dysfunction. (PX0158 (Butters Expert Report at 0002-03)).

265. Dr. Butters also opined that Respondents' advertisements convey that (1) pomegranate juice is a healthy

beverage and (2) Pom Wonderful products contain “antioxidants,” for which there has been preliminary scientific

research regarding their potential beneficial properties, and (3) readers and hearers are generally encouraged to

investigate scientific research and draw their own conclusions. (PX0158 (Butters Expert Report at 0002-03)).

h. Dr. David Reibstein
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266. Dr. David Reibstein is a tenured Professor of Marketing at the University of Pennsylvania in The Wharton

School. Dr. Reibstein has taught courses in marketing management, marketing strategy and marketing metrics to

MBA Program and Executive MBA Program students; marketing research courses to MBA Program students; and

other marketing courses to undergraduate students. Many of these courses involve the use and design of surveys.

(Reibstein, Tr. 2482; PX0356a01 at 0002-03).

267. Dr. Reibstein has been a visiting professor at Stanford Business School, Harvard Business School and

Purdue University where he taught marketing courses. Dr. Reibstein has taught courses in marketing strategy

and advanced industrial marketing strategy at INSEAD, a top business school in Europe. (Reibstein, Tr. 2483;

PX0356a01 at 0002, 0003).

268. Dr. Reibstein received his Doctor of Industrial Administration from the Herman C. Krannert Graduate School

of Industrial Administration at Purdue University with a major in marketing and a minor in behavioral science.

(Reibstein, Tr. 2481). Dr. Reibstein's doctoral dissertation was titled, “An Empirical Study of Brand Choice

and Switching Behavior.” (PX0356a01 at 0001). Dr. Reibstein attended the Master of Business Administration

Program at the Graduate Business School at Tulane University. (Reibstein, Tr. 2480-81; PX0356a01 at 0001). Dr.

David Reibstein received a B.S. in Business Administration and a B.S. in Statistics and Political Science from the

University of Kansas. (Reibstein, Tr. 2480; PX0356a01 at 0001). Dr. Reibstein has been awarded an Honorary

Master of Science by The Wharton School at the University of Pennsylvania. (PX0356a01 at 0001).

269. Dr. Reibstein was the Executive Director for the Marketing Science Institute, an organization of 72 companymembers. The Marketing Science Institute works closely with its members to identify the major marketing

issues confronting them. The Marketing Science Institute prepares reports on various marketing issues which

are disseminated to its members and the general business community. The Marketing Science Institute sets the

research agenda for marketing academia globally. (Reibstein, Tr. 2483-84; PX0356a01 at 0002).

*30 270. Dr. Reibstein has published extensively in prestigious peer-reviewed marketing journals, including

many articles on marketing and marketing research. Those journals include, among others, the Journal of

Consumer Research, Journal of Marketing Research, Marketing Science and the Harvard Business Review.

(Reibstein, Tr. 2484; PX0356a01 at 0004-07).

271. Dr. Reibstein has written over seven books and numerous chapters in books on marketing and marketing

research. (Reibstein, Tr. 2484; PX0356 (Reibstein, Dep. at 14; (PX0356a01 at 0007, 0008)). Dr. Reibstein authored

the book “Marketing Metrics: 50+ Metrics Every Executive Should Master (2006)” which was named as the “Best

Business Book: Marketing” by Strategy & Business in 2007. (PX0356a01 at 0004).

272. Dr. Reibstein has provided management education in the field of marketing to more than 300 companies. He

has designed, executed, and supervised hundreds of market research studies for over 30 years, including surveys

concerning consumer behavior. (Reibstein, Tr. 2485-86).

273. Dr. Reibstein has performed consulting research for a variety of companies where his work focuses on

understanding the reasons that customers buy, what motivates customers to buy, and the interface with customer

behavior and a company's marketing activities, price, product, place, and promotion. (Reibstein, Tr. 2484-85;

PX0356 (Reibstein, Dep. at 14-15)). Dr. Reibstein's consulting work for companies involves collecting and

processing information to better inform the company about what has or might influence customers to make the

purchase decisions they do, and in the manner they do to reduce uncertainty in the decisions they make. Dr.

Reibstein's consulting work also involves determining the messages consumers take from certain advertising.

(PX0356 (Reibstein, Dep. at 16)). Dr. Reibstein has also provided extensive management education in the field

of marketing to more than 300 companies over his career. (Reibstein, Tr. 2485).
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274. Dr. Reibstein serves on the board of the Marketing Accountability Standards Board. This board sets the

standards on what are the most important marketing metrics and how to measure them both in the United States

and globally. (Reibstein, Tr. 2485).

275. Dr. Reibstein was accepted as an expert witness in marketing and marketing research. (Reibstein, Tr. 2485).

276. Dr. Reibstein prepared for Respondents a survey analysis titled, Survey of POM Wonderful 100%

Pomegranate Juice Users (“Reibstein Survey”) to understand the underlying motivations that consumers had for

purchasing pomegranate juice and what those motivations might have been. (PX0356 (Reibstein, Dep. at 11, 39);

Reibstein, Tr. 2487).

277. As stated in the Reibstein Survey, the primary objective of the survey was to evaluate the main factors driving

the purchasing decision for POM Wonderful 100% Pomegranate juice buyers, including whether and to what

extent POM Wonderful 100% Pomegranate juice buyers purchase the product based on their belief that the product

cures or prevents a particular disease. Dr. Reibstein's finding and opinion is that there is a very small percentage

of people that bought, would buy again, or would recommend to a friend POM Wonderful Pomegranate Juice

because they believed it was beneficial to any disease. (PX0223 at 0003).

*31 278. Dr. Reibstein also reviewed the Bovitz Survey and the OTX Attitudes & Usages (“A&U”) Study. (See

Section II.J, infra). Dr. Reibstein opined that these studies have methodological flaws, cannot be relied on, and

do not invalidate the results of the Reibstein Survey. (Reibstein, Tr. 2517; PX0223 at 0003).

3. Complaint Counsel's rebuttal experts

a. Dr. Michael Mazis

279. Dr. Michael Mazis is a Professor Emeritus of Marketing at the Kogod School of Business, American

University. (PX0296 (Mazis Expert Report at 0002); Mazis Tr. 2653). He was a Professor of Marketing at

American University from 1981 to 2008, serving ten years as chair of the Department of Marketing. (PX0296

(Mazis Expert Report at 0002); Mazis, Tr. 2653).

280. Dr. Mazis has served as a paid consultant for numerous federal government agencies, including the FTC,

FDA, Consumer Product Safety Commission, Department of Justice, Federal Deposit Insurance Corporation,

Bureau of Alcohol, Tobacco and Firearms and U.S. Mint. (Mazis, Tr. 2656, 2697).

281. Dr. Mazis was employed by the FTC from July 1977 through August 1979. During that time, he was Chief

of Marketing and Consumer Research in the Office of Policy and Planning. In addition, Dr. Mazis was employed

by the FTC one day per week for a period of five or six years, beginning in the mid-1990's. He has also served as

the FTC's principal marketing witness in several cases. Dr. Mazis has been a testifying expert witness in at least

24 legal proceedings during the last four years. (PX096a001 at 0001; Mazis, Tr. 2653, 2696-98; PX0296 (Mazis

Expert Report at 0002-03, 0012); PX0359 (Mazis, Dep. at 22-24)).

282. Dr. Mazis is a former director of the Association for Consumer Research. He was Editor of the Journal of

Public Policy & Marketing from 1992 to 1995 and Associate Editor of The Journal of Consumer Affairs from 1998

to 2001. (PX0296 (Mazis Expert Report at 0002); Mazis, Tr. 2654). Among his duties as an editor and associate

editor, Dr. Mazis would review and critique survey research. (Mazis, Tr. 2655-56). Dr. Mazis has conducted
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hundreds of surveys and research studies, including over one hundred surveys for use in legal proceedings. (Mazis,

Tr. 2657).

283. Dr. Mazis was called as an expert rebuttal witness in marketing and marketing research to rebut the expert

testimony of Dr. Reibstein. (Mazis, Tr. 2659; CX1297 (Mazis Expert Report at 0002)).

284. Dr. Mazis opinioned that the Reibstein Survey contains substantial defects in its design and interpretation and

that, as a result of these flaws, no reliable conclusions can be drawn from the Reibstein Survey, with regard either

to the materiality of any of the challenged claims or to whether any of the challenged advertisements communicate

any of the challenged claims. (CX1297 (Mazis Expert Report at 0004)).

b. Dr. David Stewart

285. Dr. David W. Stewart is a full Professor of Marketing in the A. Gary Anderson Graduate School of

Management, University of California at Riverside, where he served as dean of the business school for four years

before being asked to step down. (PX0295a01 at 0002, 0041; Stewart, Tr. 3161, 3224-25; CX1295 (Stewart Expert

Report at 0002)). During his academic career, Dr. Stewart has taught a variety of graduate and undergraduate

level courses related to advertising, consumer behavior, marketing research, and marketing strategy. (PX0295a01

at 0050-51; Stewart, Tr. 3160-61; CX1295 (Stewart Expert Report at 0003-04)).

*32 286. Dr. Stewart has authored or co-authored eight books on advertising related issues and has written over

125 articles which have been accepted in peer-reviewed academic journals. (Stewart, Tr. 3162-63; PX0295a01 at

0002, 0005, 0008-17; CX1295 (Stewart Expert Report at 0002)). Dr. Stewart has served as the editor, associate

editor, or member of the editorial board of numerous academic journals. (PX0295a01 at 0043-47; CX1295

(Stewart Expert Report at 0002); Stewart, Tr. 3161). Dr. Stewart has served as the President of the Academic

Council of the American Marketing Association and chairman of the Section on Statistics in Marketing of the

American Statistical Association. (Stewart, Tr. 3161-62; PX0295a01 at 0002, 0043). He is a past president of the

Society of Consumer Psychology of the American Psychological Association. (Stewart, Tr. 3162; PX0295a01 at

0002, 0045; CX1295 (Stewart Expert Report at 0003)).

287. Dr. Stewart was accepted as an expert in advertising, marketing, consumer behavior, and survey methodology.

(Stewart, Tr. 3168).

288. Dr. Stewart was called as a rebuttal witness to respond to Respondents' expert, Dr. Butters. (Stewart, Tr.

3168).

289. Dr. Stewart opined that Dr. Butters' conclusions are inconsistent with the extant literature on consumer

response to advertising, POM Wonderful's own internal planning documents, and empirical evidence, and thus

Dr. Butters' conclusions have no merit with regard to the determination of what claims are communicated by any

challenged POM Wonderful advertisement. (CX1295 (Stewart Expert Report at 0017-18)).

E. Alleged Advertising Claims

1. Facial analysis

a. Alleged “clinically proven” claims
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i. Print advertisements

(a) CX0016 (“Drink and be healthy” print advertisement)

290. CX0016 is a POM Juice advertisement with a headline “Drink and be healthy.” CX0016 is reprinted in the

Appendix to this Initial Decision. (Appendix at 1). (CX0016 at 0001).

291. CX0016 ran once in the Chicago Tribune on October 12, 2003. (CX0016 at 0002).

292. CX0016 ran in 2003 as part of the original launch of the POM Juice product and has not been disseminated

since 2003. It was one of the first advertisements Respondents ever ran. (Tupper, Tr. 2995; L. Resnick, Tr. 157).

293. Based on the overall, common-sense, net impression of the advertisement, including the statements and

representations set forth below, a significant minority of consumers, acting reasonably under the circumstances,

would interpret CX0016 to contain the message that it is clinically proven that drinking eight ounces of POM Juice

daily prevents or reduces the risk of heart disease, by reducing arterial plaque. (CX0016 at 0002; F. 294-296).

294. CX0016 draws a clear and direct connection between consumption of POM Juice and prevention or reduction

of risk for heart disease by juxtaposing statements and representations that (a) POM Juice has more antioxidants

than other drinks, (b) antioxidants protect against free radicals, (c) free radicals can cause “heart disease,” (d)

“medical studies have shown” that consumption of POM Juice “minimizes factors that lead to atherosclerosis,”

which the advertisement defines for the reader as “plaque buildup in the arteries,” and (e) such plaque buildup is

“a major cause of heart disease.” (CX0016 at 0001).

*33 295. The statement in the advertisement that “[m]edical studies have shown that drinking 8 oz. of POM

Wonderful pomegranate juice daily minimizes factors that lead to atherosclerosis (plaque buildup in the arteries),

a major cause of heart disease” uses definitive and unambiguous language. This language draws a clear and direct

connection between the referenced proof and the claimed effect on heart disease. (CX0016 at 0001 (emphasis

added)).

296. In the context of CX0016, the elements of the advertisement communicating that POM is a food product,

including the large image of the pomegranate fruit, the reference to POM Juice as “delicious” and “refreshing,”

and the reference to POM being “[i]n the refrigerated produce section of your grocer[,]” do not materially alter

the message conveyed, described in F. 293. (CX0016 at 0001).

(b) CX0029 (“10 OUT OF 10 PEOPLE DON'T WANT TO DIE” print advertisement)

297. The advertisement for POM Juice identified as CX0029 is a POM Juice advertisement with a headline “10

OUT OF 10 PEOPLE DON'T WANT TO DIE” that ran in Prevention magazine in or about November 2004 and

January 2005. The advertisement also ran in Martha Stewart Living magazine in or about May 2005. (CX0029

at 0001-03).

298. CX0029 is reprinted in the Appendix to this Initial Decision. (Appendix at 2-3).

299. Based on the overall, common-sense, net impression of the advertisement, including the statements and

representations set forth below, a significant minority of consumers, acting reasonably under the circumstances,

would interpret CX0029 to contain the message that drinking eight ounces of POM Juice daily treats, prevents,
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or reduces the risk of heart disease, and is clinically proven to do so, by reducing arterial plaque. (CX0029 at

0001-02; F. 300-305).

300. There are elements in CX0029 that weigh against the interpretation described in F. 299. These include an

irreverent and/or humorous headline, “10 OUT OF 10 PEOPLE DON'T WANT TO DIE,” the bold notation on

the first page indicating that POM Juice is found “in the refrigerated produce section of your grocer,” the image

of the pomegranate, the reference to a study as a “pilot” study, and the language in the last paragraph which

refers to keeping “your heart healthy” with regular exercise and a healthy diet, in addition to drinking POM Juice.

(CX0029 at 0001-02).

301. Notwithstanding the elements described in F. 300, other elements in CX0029 dominate the communication,

and result in the overall net impression that consuming POM Juice prevents, reduces the risk of, or treats heart

disease, and is clinically proven to do so by reducing arterial plaque. These elements include statements and

representations that: (1) free radicals “lead to” “heart disease”; (2) antioxidants “neutralize” free radicals; (3)

“scientific research shows” that POM Juice has a superior ability to prevent LDL oxidation and a “clinical pilot

study shows that” consuming an “8 oz. glass” of POM Juice “daily” “reduces plaque in the arteries up to 30%”

with a footnoted citation to a study by Dr. Aviram published in Clinical Nutrition in 2004; (4) “heart attacks are

due to ... plaque in the arteries”; and (5) “heart disease” is America's number one killer. The language used is

affirmative and non-qualified. (CX0029 at 0001-02).

*34 302. Interspersed with the language described in F. 301 are an image of a human heart and an image of a

graph asserting POM Juice's superior abilities to prevent oxidation of LDL, which the advertisement defines as

“bad cholesterol” that “clogs arteries.” In the context of this advertisement, these images reinforce the message

conveyed by the language described in F. 301. (CX0029 at 0001-02).

303. Through the language and images described in F. 301 and F. 302, the advertisement draws a clear connection

between the consumption of POM Juice and prevention, treatment or reduction of the risk of heart disease. The

advertisement also draws a clear connection for the reader between reduced arterial plaque, as shown by the

referenced study, and prevention of heart disease. (CX0029 at 0001-02).

304. Notwithstanding the irreverent or humorous headline, “10 OUT OF 10 PEOPLE DON'T WANT TO DIE,”

the overall tone of the advertisement is serious. In addition, the advertisement resembles a news article. (CX0029

at 0001-02).

305. In the context of the language and images described in F. 301 and F. 302, the fact that the advertisement

pertains to a food product does not materially alter the message conveyed. (CX0029 at 0001-02).

(c) CX0314; CX0372; CX0379; CX0380 (“Magazine Wrap” Advertisements)

306. A “magazine wrap” is a type of advertisement that covers, or wraps, the actual magazine cover. (CX1357

at 87 (Kuyoomjian, Dep. at 86)).

307. POM disseminated a New York Times “magazine wrap” advertisement, identified as CX0314, in fall 2008,

which included the headline, “Drink to prostate health[]” with an image of the POM Juice bottle on the cover.

(CX0314 at 0003).

308. CX0372, CX0379, and CX0380 are Time magazine wraps, disseminated in August 2009 (CX0379) and

September 2009 (CX0372 and CX0380). The cover of each of these magazine wraps uses the image of the POM
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bottle “speaking” the headline, “Lucky I have super Health Powers!” The body copy of each advertisement,

CX0372, CX0379, and CX0380, is virtually identical to the body copy of CX0314. (CX0372 at 0001-04; CX0379

at 0001-04; CX0380 at 0001-06).

309. CX0314, CX0372, CX0379 and CX0380 are reprinted in the Appendix to this Initial Decision. (Appendix

at 4-26).

310. Based on the overall, common-sense, net impression of these advertisements, including the statements and

representations set forth below, a significant minority of consumers, acting reasonably under the circumstances,

would interpret CX0314, CX0372, CX0379, and CX0380 to contain the message that drinking eight ounces of

POM Juice daily treats, prevents, or reduces the risk of prostate cancer, by slowing PSA doubling times, and

that these effects have been demonstrated in clinical testing. (CX0314; CX0372; CX0379; CX0380; F. 307-308,

311-319).

311. The text on the inside front cover of each of these magazine wrap advertisements describes the results of

a published study involving POM Juice, which “followed 46 men previously treated for prostate cancer ....”

“After drinking eight ounces of POM Wonderful 100% Pomegranate Juice daily for at least two years, these men

experienced significantly slower” “PSA doubling times.” The text then draws for the viewer a clear link between

PSA levels and prostate cancer by immediately informing the viewer that “PSA (Prostate-Specific Antigen) is a

biomarker that indicates the presence of prostate cancer. ‘PSA doubling time’ is a measure of how long it takes

for PSA levels to double. A longer doubling time may indicate slower progression of the disease.” (CX0314 at

0004; CX0372 at 0002; CX0379 at 0002; CX0380 at 0002).

*35 312. CX0314 further states: “In addition, in-vitro testing using blood serum from the patients who drank

pomegranate juice showed a 17% increase in prostate cancer cell death and a 12% decrease in cancer cell growth.”

This language does not materially detract from the overall net impression that the efficacy of POM Juice has been

demonstrated in clinical testing; however, the language does represent that the degree of clinical proof is not fully

conclusive. (CX0314 at 0004).

313. The magazine wrap further states: “Backed by Science. Only POM is backed by $25 million in medical

research conducted at the world's leading universities.” The page on which these claims appeared was titled, “The

proof is in the POM.” In the context of this advertisement, these statements contribute to and reinforce an overall

net impression that efficacy for prostate cancer has been demonstrated by clinical testing. (CX0314 at 0005).

314. The text on the inside front cover of each of these magazine wrap advertisements quotes Dr. Allan Pantuck,

“lead author” of the study referenced in F. 311, as stating: “This is a big increase.” This language bolsters the

strength and authoritative nature of the study referenced in the advertisements. (CX0314 at 0004; CX0372 at 0002;

CX0379 at 0002; CX0380 at 0002).

315. The inside front cover of each of the magazine wraps states in part, “Results from this study were so promising

that many of the original patients continued to drink pomegranate juice daily, and their PSA doubling times

remained suppressed.” This statement further bolsters the strength of the referenced PSA study. Moreover, the

additional statements in this paragraph that the “[r]esearch [c]ontinues” and that “[t]hree more clinical studies are

now underway to further investigate the effects of POM on prostate health” do not materially detract from the

overall net impression that the claimed efficacy of POM Juice for prostate cancer is based upon clinically testing.

(CX0314 at 0004; CX0372 at 0002; CX0379 at 0002; CX0380 at 0002).

316. Amid the text on the inside front cover of each of these magazine wrap advertisements is the “caduceus”

symbol, showing snakes curling around a staff. In the context of this advertisement, the symbol, considered to be
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a symbol of medicine or medical practice, creates a “medical” tone and contributes to the overall net impression

described in F. 310. (CX0314 at 0004; CX0372 at 0002; CX0379 at 0002; CX0380 at 0002; see also F. 541).

317. The overall tone of each of the magazine wraps is serious. With respect to the relationship between POM Juice

and prostate cancer, the language of the advertisements is clear and affirmative, and not meaningfully qualified.

(CX0314; CX0372; CX0379; CX0380).

318. The italicized statements in the middle of the inside front cover of each magazine wrap, that “[p]rostate

cancer is the most commonly diagnosed cancer in men in the United States. After lung cancer, it's the second

leading cause of cancer death in men,” further reinforce the already serious tone of the advertisement. (CX0314

at 0004; CX0372 at 0002; CX0379 at 0002; CX0380 at 0002).

*36 319. There are elements of these magazine wraps which, in a different context, could militate against the

message described in F. 310. These include: (1) generalized references to “health,” “prostate health,” and (2)

general descriptions of POM's antioxidant characteristics and relationship to free radicals. In the context of these

advertisements, however, these elements do not materially detract from the message described in F. 310. Similarly,

in the context of these advertisements, the reference to POM Juice being “available in your supermarket produce

section” does not materially alter the overall net impression described in F. 310. (CX0314 at 0004-05; CX0372

at 0002-03; CX0379 at 0002-03; CX0380 at 0002-03).

320. In the context of these advertisements, the use of humor and/or hyperbole, such as (1) the image of the

POM bottle dressed as a caped superhero (CX0314 at 0006); and (2) the POM bottle announcing “Lucky I have

super HEALTH POWERS!” “HOLY HEALTH” and “100% PURE pomegranate juice to the rescue!” (CX0372 at

0001-02, 0004; CX0379 at 0001- 02; CX0380 at 0001-02, 0005-06) does not materially detract from the message

described in F. 310.

(d) CX0351/CX0355 (“The Only Antioxidant Supplement Rated X” print advertisement)

321. The advertisements identified as CX0351 and CX0355, with the headline, “The Only Antioxidant Supplement

Rated X,” were disseminated, respectively, in the publication the Advocate on or about June 1, 2010, and in

Playboy magazine on or about July 1, 2010. (CX0351 at 0001-02; CX0355 at 0001-02). These advertisements are

reprinted in the Appendix to this Initial Decision. (Appendix at 27-28).

322. The imagery and advertisements in CX0351 and CX0355 are substantially identical to each other. (CX0351

at 0001; CX0355 at 0001).

323. These advertisements state and represent (1) antioxidants keep you healthy by protecting against free radicals,

which “emerging science suggests” can damage the body; (2) POMx Pills give you in supplement form “superpotent,” and the best available, antioxidants, that are the same antioxidants contained in POM Juice; (3) POMx

is “backed by” millions of dollars in research, showing unique and superior antioxidant power and also revealing

“promising results for” “prostate, cardiovascular and erectile health.” (CX0351 at 0001; CX0355 at 0001).

324. These advertisements further state that “[i]n a preliminary study on erectile function, men who consumed

POM Juice reported a 50% greater likelihood of improved erections as compared to placebo. ‘As a powerful

antioxidant, enhancing the actions of nitric oxide in vascular endothelial cells, POM has potential in the

management of ED ... further studies are warranted’. International Journal of Impotence Research, '07.” (CX0351

at 0001; CX0355 at 0001).
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325. Based on the overall, common-sense net impression of CX0351 and CX0355, a significant minority of

consumers, acting reasonably under the circumstances, would interpret these advertisements as claiming that a

clinical study has shown that taking one POMx Pill daily treats, prevents or reduces the risk of, erectile dysfunction.

The advertisements specifically reference “improved erections” and “ED” and draw a direct connection between

taking POMx Pills and “improved erections” and “managing” “ED.” (CX0351 at 0001; CX0355 at 0001; F.

323-324).

*37 326. In the context of these advertisements, the use of the phrase “erectile health” or “erectile function,”

rather than the express term, “erectile dysfunction” is insufficient to alter the overall net impression that the

advertisement is conveying a message about erectile dysfunction. (CX0351 at 0001; CX0355 at 0001; see also

F. 537).

327. The headline (F. 321), and the sub-headlines “[a]lways use protection,” “[s]uper-potent just like you” and

“[w]e're not just playing doctor,” although humorous or irreverent, in the context of these advertisements, fail to

detract from the overall, net impression described in F. 325. (CX0351 at 0001; CX0355 at 0001).

(e) CX1426 at 00038-42/Compl. Ex. I (POMx “Antioxidant Superpill” Package Insert)

328. CX1426 at 0038-0042 (POMx “Antioxidant Superpill” package insert), which is attached to the Complaint in

this matter as Exhibit I, is a brochure that was disseminated by Respondents as a package insert for shipment with

POMx Pills, in or about June 2007. (CX1426 at 0038-42 (Compl. Ex. I); Answer ¶ 10; L. Resnick, Tr. 177-78:

CX1356 at 180 (Leow, Dep. at 179)).

329. The package insert consists of five pages of text and images. (CX1426 at 0038-42 (Compl. Ex. I)).

330. The package insert is reprinted in the Appendix to this Initial Decision. (Appendix at 29-33).

331. Based on the overall, common-sense, net impression of CX1426 at 0038-42, including the statements and

representations set forth below, a significant minority of consumers, acting reasonably under the circumstances,

would interpret the package insert to contain a claim that drinking eight ounces of POM Juice or taking one POMx

Pill daily treats, prevents, or reduces the risk of prostate cancer, by slowing PSA doubling times, and that these

effects have been demonstrated in clinical testing. (CX1426 at 0041 (Compl. Ex. I); F. 332, 334-336).

332. The first page of the package insert features the POMx bottle, with the headline “Antioxidant Superpill” and

the sub-headline, “POM in a Pill.” The second page of the package insert represents that POMx is safe, has been

reviewed for safety by the FDA, and that POMx has the same “polyphenol antioxidants” contained in POM Juice.

The third page of the package insert then clearly represents a link between consuming the antioxidants provided

by the POM products and prevention or reduction of the risk of disease, specifically including heart disease and

cancer, by stating or representing: (1) POMx contains the same antioxidant power as POM Juice; (2) antioxidants

fight free radicals, which “emerging science tells us” destroy healthy cells and “may be linked to ... serious health

threats like cancer and heart disease”; and (3) antioxidants “neutralize” free radicals, thereby “helping to prevent

the damage that can lead to disease.” (CX1426 at 0038-40 (Compl. Ex. I)).

333. The fourth page of this package insert begins with a headlined quotation attributed to the July 4, 2006

New York Times that findings from a small study suggest that pomegranate juice “may one day prove” an

effective weapon against prostate cancer and statements that “new studies are under way to further investigate.”

This headline does not materially detract from the overall net impression that the efficacy of POMx has been
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demonstrated in clinical testing; however, the headline does indicate that the degree of clinical proof is not fully

conclusive. (CX1426 at 0041 (Compl. Ex. I)).

*38 334. The fourth page of the package insert states or represents that (1) “Prostate cancer is the most commonly

diagnosed cancer ... and the second-leading cause of cancer death” among men in the United States; (2) POMx

is a “time pill” because “stable levels of PSA,” which is defined for the reader as “prostate-specific antigens,”

are “critical for men with prostate cancer,” “[p]atients with quick PSA doubling times are more likely to die

from their cancer,” and “[a]ccording to a UCLA study of 46 men age 65 to 70 with advanced prostate cancer,

drinking an 8oz glass of POM Wonderful 100% Pomegranate Juice every day slowed their PSA doubling time by

nearly 350%. 83% of those who participated in the study showed a significant decrease in their cancer regrowth

rate”; and (3) “basic studies” indicate POMx may have the same effects as POM Juice with respect to “prostate

health.” (CX1426 at 0041 (Compl. Ex. I)).

335. The package insert expressly refers to “prostate cancer.” Moreover, the representations in F. 334, especially

in the context of previous representations regarding the effect of POM antioxidants on cancer (F. 332), represent

a connection between the consumption of POMx, a slowing of PSA doubling times, and a beneficial effect on the

progress of prostate cancer, including avoiding death from prostate cancer. (CX1426 at 0041 (Compl. Ex. I)).

336. In addition, references on the final page of the advertisement to “backed by $20 Million in medical research”

and “clinically tested on adults” tend to bolster the nature and amount of clinical research or testing supporting

the efficacy of the POM products for prostate cancer. (CX1426 at 0042 (Compl. Ex. I)).

337. In the context of this advertisement, use of the phrase “promote prostate health” is insufficient to alter the

overall net impression that the advertisement is conveying a message about prostate cancer. (CX1426 at 0041

(Compl. Ex. I)).

338. Based on the overall, common-sense, net impression of CX1426 at 0038-42, including the statements and

representations set forth below, a significant minority of consumers, acting reasonably under the circumstances,

would interpret this package insert to contain a claim that drinking eight ounces of POM Juice or taking one

POMx Pill daily treats, prevents or reduces the risk, of heart disease, by reducing arterial plaque or improving

blood flow to the heart, and that these effects have been demonstrated by clinical testing. (CX1426 at 0038-42

(Compl. Ex. I); F. 339-342).

339. The final page of the package insert begins with a headline, which represents that POMx may have the

same “cardiovascular health benefits” as POM Juice, which has been “proven” to “promote cardiovascular

health.” This page further represents: (1) “groundbreaking” “preliminary studies” showed that “patients” who

drank POM Juice “experienced impressive cardiovascular results”; including (2) a “pilot” study on 19 “patients”

with “atherosclerosis,” which the text defines for the reader as “clogged arteries,” showed that “arterial plaque

decreased 30%” for those that consumed 8 oz. of POM Juice daily”; (3) an “additional study” of 45 “patients”

with “impaired blood flow to the heart” who drank POM Juice daily “experienced a 17% improvement in blood

flow”; (4) POMx has “similar promise” for heart health; (5) POMx is high in antioxidants; and (6) “backed by $20

Million in medical research” and “clinically tested on adults.” Depicted within these representations is an image

captioned as “the heart.” (CX1426 at 0042 (Compl. Ex. I)).

*39 340. The representations regarding “impressive cardiovascular results,” a decrease in “clogged arteries”

and “improvement in blood flow to the heart” in “patients,” appear in the context of preceding representations

regarding the effect of POM antioxidants on heart disease. Moreover, the representations of “proven” heart health

benefits in the headline are juxtaposed to the descriptions of these study results. (CX1426 at 0042 (Compl. Ex.

I); F. 339).
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341. The package insert represents a link between consumption of POM-provided antioxidants, the referenced

study results, and effectiveness for heart disease. (F. 339-340).

342. In the context of this advertisement, describing studies as “preliminary,” (particularly when described as

“groundbreaking”), “initial” or “pilot” is insufficient to modify the overall net impression that the claimed efficacy

is based upon clinical testing; however, such language does indicate that the nature of the referenced clinical

testing is not fully conclusive. (CX1426 at 0038-42 (Compl. Ex. I); F. 338-341).

ii. Newsletters

343. The advertisements identified as CX1426 at 0046-48, which comprises Exhibit M to the Complaint in this

matter, and CX1426 at 0049-51, which comprises Exhibit N to the Complaint, were disseminated by Respondents.

(CX1426 at 0046-51; Complaint ¶ 10; Answer ¶ 10). These advertisements are reprinted in the Appendix to this

Initial Decision. (Appendix at 34-39).

344. Exhibit M to the Complaint contains a notation, “POMx Heart Newsletter, Pills and Liquid, Monthly, 2nd

Continuity Shipment, Summer ‘07-present (ongoing)” (hereafter, “Heart Newsletter”). Exhibit N to the Complaint

contains the notation, “POMx Prostate Newsletter, Pills and Liquid, Monthly, 3rd Continuity Shipment, Fall ‘07-

present (ongoing)” (hereafter, “Prostate Newsletter”) (collectively, the “Newsletters”). (CX1426 at 0046, 0049

(Compl. Exs. M, N)).

345. Each Newsletter consists of two pages, and is dense with text. (CX1426 at 0047-48, 0050-51(Compl. Exs.

M, N)).

(a) Heart Newsletter

346. Based on the overall, common-sense, net impression of the Heart Newsletter, including the statements and

representations in F. 347-349, a significant minority of consumers, acting reasonably in the circumstances, would

interpret the Heart Newsletter as claiming that that drinking eight ounces of POM Juice or one POMx Pill taken

daily, prevents, treats, or reduces the risk of heart disease, by decreasing arterial plaque, or by improving blood

flow to the heart, and that these effects are based upon clinical testing. (CX1426 at 0047-48 (Compl. Ex. M);

F. 347-350).

347. The Heart Newsletter begins with the heading “What's New in the Lab by Dr. Mark Dreher” followed by a

photograph of Dr. Dreher next to his title: Mark Dreher, PhD, Chief Science Officer, POM Wonderful, LLC. The

introductory text, by Dr. Dreher, represents that the purpose of the Heart Newsletter is to advise readers of POM

Wonderful's “latest research.” This beginning to the Heart Newsletter implies a scientific or medical message.

(CX1426 at 0047 (Compl. Ex. M)).

*40 348. The Heart Newsletter states or represents that (1) “58.8 million Americans suffer from some form of

heart disease” and that reducing the risk of “cardiovascular disease” is a core part of lifelong wellness; (2) that diet

and exercise are the best weapons against “heart disease”, but may not be enough, and that supplementation with

antioxidants is “your ally” in fighting “heart disease”; (3) antioxidants fight free radicals and help prevent cell and

tissue damage that lead to “disease”; (4) POM Juice and POMx have polyphenol antioxidants, which are unique

and superior; and (5) POMx provides antioxidant supplementation without adding the calories of POM Juice.
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These representations draw a connection for the reader between POM antioxidants and prevention or reduction

of the risk of heart disease. (CX1426 at 0047-48 (Compl. Ex. M)).

349. The Heart Newsletter further states that POM's “scientists have found” that POM Juice “may help counteract

factors leading to arterial plaque build up, as well as inhibit a number of factors associated with heart disease.”

The text then proceeds to describe these findings, from “new research,” including (1) a “pilot” study involving

19 “patients” with “clogged arteries” which found a “30% decrease in arterial plaque,” among those drinking

eight ounces of POM Juice daily; and (2) a study involving 45 “patients” with “impaired blood flow to the

heart,” showing “17% improved blood flow” among those who consumed eight ounces of POM Juice daily. The

Heart Newsletter further states that “the antioxidants in POMx are supported by $20 million in initial scientific

research.” (CX1426 at 0048 (Compl. Ex. M)).

350. The representations set forth in F. 349, in the context of the representations in F. 348, draw a connection

between reducing arterial plaque and treating, preventing, or reducing the risk of heart disease. (CX1426 at 0048

(Compl. Ex. M)).

(b) Prostate Newsletter

351. Based on the overall, common-sense, net impression of the Prostate Newsletter, including the statements and

representations described in F. 352 and F. 353, below, a significant minority of consumers, acting reasonably in

the circumstances, would interpret the Prostate Newsletter as claiming that drinking eight ounces of POM Juice

or one POMx Pill taken daily, prevents, treats, or reduces the risk of prostate cancer, by prolonging PSA doubling

time, and that these effects are clinically proven. (CX1426 at 0050-51 (Compl. Ex. N); F. 352-354).

352. The Prostate Newsletter draws a clear link for the reader between antioxidants and reduction of the

risk of prostate cancer, including through the following statements or representations: The Prostate Newsletter

states prominently “Prostate Cancer Affects 1 Out of Every 6 Men,” and that “Prostate cancer is the second

leading cause of cancer related death in men in the United States ...” The associated text discusses “risk

factors” for prostate cancer, including “diet,” and advises a diet that includes, among other things, “fruits rich in

antioxidants.” (CX1426 at 0050-51 (Compl. Ex. N)).

*41 353. The Prostate Newsletter draws a connection for the reader between research results showing prolonged

PSA doubling time and effectiveness for prostate cancer, including through statements or representations that:

early detection, including through a PSA test, increases prostate cancer survival rates; a “preliminary UCLA

medical study” on 46 men treated for prostate cancer, showed that a majority of those consuming eight ounces

of POM Juice daily “experienced a significantly extended PSA doubling time. Doubling time is an indicator

of prostate cancer progression — extended doubling time may indicate slower disease progression”; testing on

“patient” blood serum showed a decrease in “cancer cell proliferation,” and “increase in cancer cell death”; in

another study, “in vitro laboratory testing at UCLA showed that POMx significantly decreased human prostate

cancer cell growth and increased cancer cell death” and that POMx has the same active ingredients in POM Juice.

(CX1426 at 0050-51 (Compl. Ex. N)).

354. In the context of the Prostate Newsletter, reference to research as “preliminary” or “in vitro” is insufficient

to modify the claim described in F. 351 that the claimed efficacy is based upon clinical testing, particularly in

light of other statements and representations promoting the strength and credibility of the research, as part of $25

million in “world-class research” including “clinical studies published in top peer-reviewed medical journals.”

Such language does, however, indicate that the degree of proof provided by the referenced studies is not fully

conclusive. (CX1426 at 0050-51 (Compl. Ex. N)).
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iii. Website advertising

(a) Website background facts

355. POM's websites include pomwonderful.com, pomegranatetruth.com, and pompills.com (collectively, the

“websites”). (JX0003 ¶ B.11; Rushton, Tr. 1354-55; Leow, Tr. 433).

356. POM has maintained the pomwonderful.com website since approximately January 2003. (CX0013 at 0004).

It has maintained the pomegranatetruth.com website since approximately January 2008. (CX0170 at 0002). POM

launched pompills.com in early 2007. (CX1347 (Glovsky, Dep. at 135-36)).

357. Since at least September 2007, POM has had an online department. The online department is part of POM's

marketing department and handles anything related to the Internet, including marketing, engagement, interaction,

and development. (Rushton, Tr. 1353-54).

358. Jeffrey Rushton was the Director of Marketing for Online for POM Wonderful, from September 2007 through

March 2010. (Rushton, Tr. 1353).

359. In approximately 2008, POM converted pomwonderful.com from a traditional static format to a blog format

that sought engagement from external sources. (Rushton, Tr. 1354). POM launched this “Community” version of

pomwonderful.com in approximately December 2009. (CX0473 (Dec. 2009, pomwonderful.com)).

360. In October 2009, one of the rotating frames on the pomwonderful.com homepage welcomed consumers

to its “new community site.” (CX0473 (Oct. 2009, pomwonderful.com at 00:25)). The “community” design

encouraged website visitors to “participate,” including by “Tell[ing] Us Your Health Story.” (CX0473 (Oct. 2009,

pomwonderful.com at 00:25)).

*42 361. Testimonials appeared on the POM Wonderful website briefly, for much less than a year. (L. Resnick,

Tr. 134).

362. The “Community” section of the pomwonderful.com site also featured blog posts and videos by “POM

Experts” like Dr. Aviram, Dr. Heber, and Susan Bowerman, Assistant Director at the UCLA Center for Human

Nutrition. (CX0473 (Oct. 2009, pomwonderful.com at 06:52)). POM paid Susan Bowerman to, among other

things, write blog posts for pomwonderful.com. (CX0203 at 0001; CX1346 (Rushton, Dep. at 145)).

363. To direct traffic to its website, POM used keyword advertising with search engines. With keyword

advertising, marketers can pay for their advertisements to appear on the search results pages of search engines

such as Google, Yahoo, Bing, among others, by purchasing keywords that consumers may search for. (Rushton,

Tr. 1357-58).

364. Examples of keywords POM has used in its search engine advertising include: “prostate cancer prevention,”

“prostate cancer info,” “prostate cancer research,” and “cancer prostate.” (CX0427 at 0004-05, 0007-08; Rushton,

Tr. 1387-89).

(b) Website claims
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365. CX0473 consists of electronically recorded “captures” of Respondents' websites on particular dates, as

follows:

Pomwonderful.com — April, October, December, 2009 and January 2010;

Pompills.com — April 2009 and January 2010; and

Pomegranatetruth.com — April 2009

(CX0473).

366. Each website capture reflects an electronic recording of navigation through the pages of the subject website,

“clicking” on various hyperlinks to other pages. The web captures total approximately 95 minutes of material, with

each capture totaling approximately 15 minutes in length, except for CX0473 Ex. E-1 (pomegranatetruth.com),

which is approximately 5 minutes in length. (CX0473).

367. Printouts of those pages referred to in the following findings are reprinted in the Appendix to this Initial

Decision. (Appendix at 40-93).

(i) Pomwonderful.com

368. Based on the overall, common-sense, net impression of the pomwonderful.com website, including the “health

benefits” or “health” pages and links therefrom, a significant minority of consumers, acting reasonably in the

circumstances, would interpret the pomwonderful.com website as claiming that drinking eight ounces of POM

Juice daily treats, prevents, or reduces the risk of heart disease, prostate cancer, and/or erectile dysfunction, and

that these effects are shown in clinical testing, as more fully explained below. (CX0473 (pomwonderful.com

website: April 2009 (Compl. Ex. E-2); October 2009, December 2009, January 2010); F. 369-381).

369. In April 2009, the pomwonderful.com homepage included a link to a “health benefits” page. (CX0473

(Compl. Ex. E-2 at 00:04 and 00:15)).

370. In April 2009, the linked “health benefits” webpage displayed a large graphic depicting the POM Juice bottle

hanging upside down on a pole, with the juice running through a tube at the bottom of the bottle, in the manner of a

hospital intravenous line, while the juxtaposed text refers to POM Juice being “backed by” $25 million in “medical

research” and “clinically tested.” The page then introduces the “medical results” in separate areas designated

“cardiovascular health,” “prostate health,” and “erectile function” sections. Introductory text in each such section

summarizes research, with the cardiovascular section providing a further link to “read more.” (CX0473 (Compl.

Ex. E-2 at 00:17)).

*43 371. In April 2009, the “Prostate Health” section of the health benefits webpage described “[a] preliminary

UCLA medical study” on “46 men previously treated for prostate cancer,” published by “The American

Association for Cancer Research,” showing that after drinking eight ounces of POM Juice daily for two years,

“these men experienced significantly slower PSA doubling times.” The description clearly links the significance of

this research finding to prostate cancer, stating “PSA is a biomarker for prostate cancer, and slower PSA doubling

time may indicate slower disease progression.” (CX0473 (Compl. Ex. E-2 at 00:24)).
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372. In April 2009, the “Erectile Function” section of the health benefits webpage reported a 2007 “pilot” study,

published in the International Journal of Impotence Research, involving 61 male subjects with “mild to moderate

erectile dysfunction,” showing that those men drinking eight ounces of POM Juice daily for four weeks “were

50% more likely to experience improved erections.” (CX0473 (Compl. Ex. E-2 at 00:24)).

373. In April 2009, the “Cardiovascular” section of the health benefits webpage described the results of studies as

follows: (1) a 2005 study published in the American Journal of Cardiology, involving 45 “patients” with “coronary

heart disease who had reduced blood flow to the heart,” showed that “patients” who drank eight ounces of POM

Juice daily had “improved blood flow to the heart,” while those who did not drink POM Juice got worse; and (2)

a “pilot” study on 19 “patients” with “atherosclerosis,” which the text defines for the reader as “clogged arteries,”

showing that those “patients” who drank eight ounces of POM Juice daily for one year showed a decrease in

arterial plaque, while those who did not drink POM Juice got worse. Each of these study descriptions offered a

“read more” link. (CX0473 (Compl. Ex. E-2 at 00:24)).

374. In April 2009, the “read more” link from the “Cardiovascular” section of the health benefits webpage took

the viewer to a page titled, “Heart Health-Emerging Science.” The text advises the reader that “heart disease” is

a leading killer of men and women in the United States, that “atherosclerosis,” which is defined for the readers

as too much “plaque,” is a leading factor in “heart attacks” and further describes the role of antioxidants in

reducing LDL (defined as “bad” cholesterol) oxidation. The text then invites the reader who wants to learn more

about consumption of POM Juice and cardiovascular health, to “click on” the links to a 2005 study on effect of

pomegranate on myocardial perfusion published in the American Journal of Cardiology; a 2004 study on reduction

of carotid intima-media thickness, blood pressure and LDL oxidation, published in the journal, Clinical Nutrition;

and a 2001 study on reduction of systolic blood pressure, published in the journal, Atherosclerosis. This page draws

a clear connection for the reader between “heart health” and “heart disease,” and between the effects referenced

in the studies and effectiveness for heart disease. (CX0473 (Compl. Ex. E-2 at 00:30)).

*44 375. While the link to the 2005 myocardial perfusion study (F. 374) took the viewer to a reprint of a copy of

the actual published study, (CX0473 (Compl. Ex. E-2 at 00:45)), the link to the 2004 study on reduction of carotid

intima-media thickness, blood pressure and LDL oxidation (F. 374)) took the viewer to a further description of

the study with highlighted commentary by Dr. Aviram and graphs emphasizing the reduced plaque and “antiatherosclerotic” effects of POM Juice. At the top of this page was a quote attributed to Dr. Aviram that “[t]he

present study clearly demonstrates for the first time that pomegranate juice consumption by patients with carotid

artery stenosis possesses anti-atherosclerotic properties.” (CX0473 (Compl. Ex. E-2 at 01:00, 01:06)).

376. The link to the 2001 study on reduction of systolic blood pressure (F. 374) took the viewer to a further

description of the study. The description begins: “This pilot study demonstrates that pomegranate juice lowers

blood pressure in patients with hypertension.” A quote attributed to Dr. Aviram states that the “potent inhibitory

effect on lipid peroxidation” and the “inhibitory effect of pomegranate juice on serum ACE activity” “suggest[]

that pomegranate juice consumption may offer wide protection against cardiovascular diseases.” The decreased

ACE (angiotensin converting enzyme) activity is illustrated by a graph. (CX0473 (Compl. Ex. E-2 at 01:25)).

377. In April 2009, the “Health Benefits” section of pomwonderful.com also included links to other pages,

including one titled, “Cancer.” (CX0473 (Compl. Ex. E-2 at 01:44)).

378. In April 2009, the linked “Cancer” page stated: “Emerging science has shown that diets rich in fruits and

vegetables that contain antioxidants, along with regular exercise, might slow or help prevent the development

of cancer. Two great sources of antioxidants are POM Wonderful Pomegranate Juice and POM Tea.” The page

featured a link to the “Clinical Cancer Research.” (CX0473 (Compl. Ex. E-2 at 03:45)).
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379. In April 2009, pomwonderful.com included a “Glossary,” which was linked to the “Health Benefits” page.

A number of definitions reasserted and reinforced the study results referred to F. 374-376. For example, the

definitions of “Atherosclerosis,” “ACE” (i.e., angiotensin-converting enzyme), and “plaque” provided in the

glossary explain for the reader the purported connection between the effects shown by the study results and effects

for heart disease. (CX0473 (Compl. Ex. E-2 at 01:44, 04:15-07:08)).

380. Having fully reviewed later versions of the pomwonderful website, captured in October and December in

2009, and January 2010, they are not materially different with respect to linking viewers to text summarizing

research results, under the categories of cardiovascular, prostate cancer, and erectile “function,” and drawing a

connection for the reader between consumption of POM antioxidants, the research results summarized, and the

prevention, treatment, or reduction of the risk of diseases associated with the conditions addressed in the research

results. Thus, these later versions of the pomwonderful website also convey the claims described in F. 368 as to

the April 2009 website. (CX0473; F. 381).

*45 381. As an example that later versions of the pomwonderful website also convey the claims described

in F. 368 as to the April 2009 website, in October 2009, links from the “health” page directed the viewer to a

“research study synopses,” link, which page further stated inter alia: (1) under “cardiovascular,” the rate of “CIMT

progression” slowed in nearly one-third of the “patients” having “cardiovascular risk factors,” (CX0473 (Oct.

2009, pomwonderful.com at 02:43)); (2) under “prostate cancer,” that “PSA doubling time increased” among the

POM Juice drinkers, and that “PSA doubling time is an indicator of prostate cancer progression, (Id.); and (3)

under “Erectile Function,” that POM Juice drinkers “reported 50% greater likelihood of experiencing improved

erections.” (Id. at 02:52; see also CX0473 (January 2010, pomwonderful.com at 00:26; 00:50, “Featured Scientific

Studies” page)); CX0473 (December 2009, pomwonderful.com, “Let's Talk about Prostate Cancer” video, in

which Dr. Heber states, inter alia, that “pomegranate inhibits inflammation in the prostate gland, that it also inhibits

prostate cancer growth in animals, both in early prostate cancer and advanced prostate cancer. And in humans, we

were able to reduce the rate of rise of PSA in men with prostate cancer”); CX0473 (Dec. 2009, pomwonderful.com

at 08:06; CX0473 (Jan. 2010, pomwonderful.com at 00:54, and CX0473 (October 2009 pomwonderful.com

at 7:25 (Dr. Aviram stating, regarding “The Unique Antioxidants of Pomegranates,” that pomegranates inhibit

“atherosclerosis development, ... as well as its consequent cardiovascular events”)).

382. The “POM Community” section of pomwonderful.com in December 2009 included consumer testimonials.

(CX0336 at 0011-19).

383. Testimonials were in the “POM Community” section of pomwonderful.com for much less than a year. (L.

Resnick, Tr. 134).

384. Attached to the expert report of Respondents' linguistic expert, Dr. Butters, is a copy of what Dr. Butters

identified as printouts from the pomwonderful.com website in 2011, taken on or before March 25, 2011, the date

of Dr. Butters' report. As of that date, the “health” page omits reference to “protective effects,” does not refer to

any diseases, and does not summarize research results. The linked “glossary” omits the references described in F.

379. (PX0158 (Butters Expert Report at 0042); PX0160 at 0029-36, 0038-53, attachment 3) (“2011 website”)).

385. The health page of the 2011 website (F. 384) does provide a link to “view studies” on the POM products,

which when activated brings up a disclaimer that the studies are not “intended to make express or implied

health or disease claims, ... do not constitute ... advertising for any POM Wonderful product .... Instead

they are intended solely for general educational and informational purposes.” The linked website is titled

“wonderfulpomegranateresearch.com.” (PX0158 (Butters Expert Report); PX0160 at 0036-37, attachment 3)).
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(ii) Pompills.com

*46 386. The pompills.com website is an e-commerce site that contains everything from learning about the

product to ordering the product. (CX1347 (Glovsky, Dep. at 135)).

387. Based on the overall, common-sense, net impression of the pompills.com website, including the “health

benefits” or “medical research” sections and the links to other information included therein, a significant minority

of consumers, acting reasonably in the circumstances, would interpret the pompills.com website to be claiming that

taking one POMx Pill, or one teaspoon of POMx Liquid, daily, treats, prevents, or reduces the risk of heart disease,

prostate cancer, and/or erectile dysfunction, and that these effects are shown in clinical testing, as explained more

fully below. (CX0473 (Pompills.com website: April 2009 (Compl. Ex. E-8)), January 2010 (Compl. Ex. E-9);

F. 388-410).

388. In April 2009, the menu bar on the home page of pompills.com contained links, inter alia, to “POMx Pills,”

“POMx Liquid,” “health benefits” and “Buy Now.” In January 2010, the menu bar was the same but the “health

benefits” link is replaced by a link to “medical research.” (CX0473 (Compl. Ex E-8 at 00:10); CX0473 (Compl.

Ex E-9 at 00:04)).

389. A review of the April 2009 and January 2010 web captures show that the pompills.com website made

substantially the same representations as those contained in POMx Pill print advertising, described in F. 323 and F.

332, including that POMx Pills provide the same antioxidant “power” as POM Juice, without the calories (CX0473

(Compl. Ex. E8 at 00:15-00:25); CX0473 (Compl. Ex. E-9 at 00:16)); that POMx Pills have the best available,

polyphenol antioxidants (CX0473 (Compl. Ex. E-8 at 00:25); CX0473 (Compl. Ex. E-9 at 00:16, 00:30)); and that

antioxidants “fight” free radicals which are linked to, among other things, “cancer and heart disease.” (CX0473

(Compl. Ex. E-8 at 04:37); CX0473 (Compl. Ex. E-9 at 01:01); see also CX0351; CX0355; CX1426 at 0040

(Compl. Ex. I) (POMx package insert)).

390. In April 2009, the POMx Liquid page on pompills.com stated that POMx Liquid is “the most concentrated

source of pomegranate antioxidants available,” and that “POMx Liquid is a highly concentrated, incredibly

powerful blend of all-natural polyphenol antioxidants made from the very same pomegranates in POM Wonderful

100% Pomegranate Juice.” The page also depicted the POMx Liquid bottle and teaspoon with the caption, “One

teaspoon = the antioxidant power of 8oz. of POM Wonderful 100% Pomegranate Juice” and a link to “BUY

NOW.” The menu bar on the POMx Liquid webpage also included a link to “health benefits.” (CX0473 (Compl.

Ex. E-8 at 01:00 1:38)).

391. In April 2009, under the subheading “Science, Not Fiction,” the POMx Pills page represented, inter alia, that

POMx is “backed by $25 million in medical research,” and is “[c]linically tested.” (CX0473 (Compl. Ex. E-8 at

00:35); see also January 2010 pompills.com (CX0473 (Compl. Ex. E-9 at 00:16 ($32 million); CX1426 at 0040

(Compl. Ex. I) (POMx package insert ($20 Million in research)).

*47 392. In April 2009 and January 2010, the POMx Liquid page on pompills.com contained the same language

as set forth in F. 392 that appeared on the POMx Pills page. (Compare CX0473 (Compl. Ex. E-8 at 00:35) with

CX0473 (Compl. Ex. E-8 at 01:15); see also January 2010 pompills.com (CX0473 (Compl. Ex. E-9 at 00:30)

($32 million in research)).

393. In April 2009, and in January 2010, the “Health Benefits” section of pompills.com offered further links to

web pages titled, “Research,” “Antioxidant Benefits,” “Heart Health,” and “Prostate Health.” (CX0473 (Compl.

Ex. E-8 at 01:38); CX0473 (Compl. Ex. E-9 at 00:36)).
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394. In April 2009, and in January 2010, the “Heart Health” section advised the reader that arterial plaque buildup

is one of a number of factors “associated with heart disease” that POM Juice consumption may help “counteract.”

In the context of this webpage, the term, “heart health” implies “heart disease.” (CX0473 (Compl. Ex. E-8 at

05:05); CX0473 (Compl. Ex. E-9 at 00:36).

395. In April 2009, the “Learn more” link on the “Heart Health” webpage took the consumer to a page titled “The

Heart of The Matter.” This page, in April 2009 and in January 2010, noted that atherosclerosis, defined for the

reader as “too much plaque in the arteries[]is a leading cause of heart disease” and that “pomegranate antioxidants

neutralize free radicals,” which “can oxidize LDL (also known as ‘bad’ cholesterol turning it into plaque that clogs

up arteries.” This page then summarizes results of the Aviram Carotid Intima-media Thickness/Blood Pressure

(“CIIMT/BP”) Study and the Ornish Myocardial Perfusion (MP) Study in a manner that is substantially similar

to the summaries on pomwonderful.com. (CX0473 (Compl. Ex. E-8 at 05:09-05:10); CX0473 (Compl. Ex. E-9

at 01:22); see F. 373-374).

396. In April 2009, and in January 2010, the linked “Heart of The Matter” page on pompills.com displayed a

large image of the caduceus symbol, juxtaposed to a subheading “Amaze your cardiologist. Take POMx.” This

language and imagery convey a medical message. (CX0473 (Compl. Ex. E-8 at 05:09-05:10); CX0473 (Compl.

Ex. E-9 at 01:22)).

397. The language on the “Heart of The Matter” page of the pompills.com website that POMx is made from

pomegranates “supported by $25 million of initial scientific research” reinforces the message that the efficacy

of POMx for heart disease is demonstrated by the results of clinical research. (CX0473 (Compl. Ex. E-8 at

05:09-05:10); see also CX0473 (Compl. Ex. E-9 at 01:22 (“supported by $32 million”)).

398. In April 2009, the “Antioxidant Benefits” page of the pompills.com website advised the reader that

“antioxidants neutralize free radicals,” which are “linked to [among other things] cancer and heart disease,” and

that POMx is made from pomegranates having “$25 million in medical research behind them.” This language,

which also appears in the January 2010 version of pompills.com (“$32 million”), draws a connection for the

viewer between antioxidants and disease, and conveys the message of scientific support for the website's claims.

(CX0473 (Compl. Ex. E-8 at 04:37, 04:50); CX0473 (Compl. Ex. E-9 at 01:01)).

*48 399. In April 2009, the “Research” link on the “Health Benefits” section of pompills.com took the viewer

to a list of linked studies, including “Cardiovascular” studies and “Cancer” studies. The text of the links include:

“Pomegranate juice improves myocardial perfusion in coronary heart patients,” “Pomegranate juice pilot research

suggests anti-atherosclerosis benefits,” “Pomegranate juice helps promote normal systolic blood pressure.” The

“Research” page of the January 2010 version of pompills.com contains the same text. (CX0473 (Compl. Ex. E-8

at 01:38); CX0473 (Compl. Ex. E-8 at 01:43-04:23); CX0473 (Compl. Ex. E-9 at 00:55))

400. Some of the linked study titles referred to in F. 399 appear to be paraphrases of the studies' actual

titles. (CX0473 (Compl. Ex. E-8 at 01:43-04:23); see, e.g., CX0473 (Compl. Ex. E-8 at 02:10) (study listed

as “Pomegranate juice improves myocardial perfusion in coronary heart patients,” was published with the title,

“Effects of Pomegranate Juice Consumption on Myocardial Perfusion in Patients with Coronary Heart Disease”);

CX0473 (Compl. Ex. E-8 at 02:45) (study listed as “Pomegranate juice delays PSA doubling time in humans,”

was published with the title “Phase II Study of Pomegranate Juice for Men with Rising Prostate-Specific Antigen

following Surgery or Radiation for Prostate Cancer”)).

401. In April 2009, and in January 2010, the “Prostate Health” section of the “Health Benefits” page on

pompills.com stated: “A preliminary UCLA medical study on POM Wonderful 100% Pomegranate Juice showed

hopeful results for men with prostate cancer who drank an 8oz. glass of pomegranate juice daily. And every
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POMx capsule provides the antioxidant power of an 8oz. glass of POM Wonderful 100% Pomegranate Juice.

Learn more.” (CX0473 (Compl. Ex. E-8 at 05:50); CX0473 (Compl. Ex. E-9 at 00:36) (underlined hyperlink in

original)). The “Learn more” link took the consumer to a page titled “Pomegranates and Prostate Health.” (CX0473

(Compl. Ex. E-8 at 05:55)).

402. Like “The Heart of the Matter” page (F. 397), in April 2009, the “Pomegranates and Prostate Health” page

displayed the caduceus symbol. (CX0473 (Compl. Ex. E-8 at 05:55)).

403. In April 2009, on the “Pomegranates and Prostate Health” page of the pompills.com website, the explanatory

text under the subheading “Prostate Health” states or represents: “Prostate cancer is the most commonly diagnosed

cancer among men in the United States, and the second leading cause of cancer death in men, after lung cancer.”

In the context of this webpage, the reference to “prostate health” clearly implies “prostate cancer.” The text then

describes a study in which “A majority of the 46 men participating in the study experienced a significantly extended

PSA doubling time .... Before the study of pomegranate juice, the average PSA doubling time for the participants

was 15 months. After drinking 8oz. of juice daily, the average PSA doubling time increased to 54 months. That's

a 350% increase.” (CX0473 (Compl. Ex. E-8 at 05:55)).

*49 404. The April 2009 the “Pomegranates and Prostate Health” page of the pompills.com website further

linked the study results showing prolongation of PSA doubling time to the progress of prostate cancer, explaining

“PSA (prostate-specific antigen) is a marker that is thought to be associated with the progression of prostate

cancer; a slower PSA doubling time may reflect slower progression of the disease.” Placing the mouse over the

hyperlinked word “doubling time” produced a pop-up text box that reiterated: “The amount of time it takes for

the prostate-specific antigen[s] (also called PSA levels) to double in men with prostate cancer may reflect the

progression of the disease. A longer doubling time may indicate a slower growing cancer.” (CX0473 (Compl. Ex.

E-8 at 05:55-05:59, underlined hyperlink in original)).

405. The April 2009 the “Pomegranates and Prostate Health” page further represented that study results for POM

Juice should apply to POMx by quoting Dr. Heber, identified as “Director of UCLA's Center for Human Nutrition,”

as stating: “The most abundant and most active ingredients in Pomegranate Juice are also found in POMx. Basic

studies in our laboratory so far indicate that POMx and Pomegranate Juice have the same effect on prostate health.”

The foregoing text was printed in bold font and was italicized. (CX0473 (Compl. Ex. E-8 at 05:59)).

406. In April 2009, the pompills.com website also featured a “FAQs” page. (CX0473 (Compl. Ex. E-8 at 07:51)).

407. In April 2009, the response to the FAQ “Heart Disease: How does drinking pomegranate juice help the fight

against cardiovascular disease?” stated: (1) “Improved Cardiac Blood flow,” juxtaposed to the representation that

a “published human study ... [on] 45 patients with impaired blood flow to the heart” showed that “[p]atients” who

drank eight ounces of POM Juice “daily” experienced “improved blood flow” while the blood flow of the placebo

group declined; and (2) “Decrease in Arterial Plaque” juxtaposed to the representation that “[a]nother published

human study ... [on] 19 patients with atherosclerosis (clogged arteries) showed that, for those who drank eight

ounces of POM Juice “daily,” “artery plaque decreased 30%” while the placebo group experienced a worsening

of arterial plaque buildup. This page further represented that results for POM Juice are applicable to POMx by

quoting Dr. Aviram, identified as “one of the world's preeminent cardiovascular researchers,” as commenting:

“The results of our pre-clinical studies showed that POMx is as potent an antioxidant as pomegranate juice, and

just like pomegranate juice may promote cardiovascular health.” The foregoing quotation was italicized. (CX0473

(Compl. Ex. E-8 at 09:05)).

408. In April 2009, the response to the FAQ “Erectile Dysfunction” stated: “Can pomegranate juice benefit men

with erectile dysfunction?” stated: “Initial results linking POM Wonderful 100% Pomegranate Juice and erectile
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performance are promising. In a soon-to-be-published clinical study on men with erectile dysfunction, the group

who consumed 8oz. of POM Juice daily experienced better erectile performance than the group who drank a

placebo.” (CX0473 (Compl. Ex. E-8 at 9:05)).

*50 409. In April 2009, the response to the FAQ “Prostate Cancer” stated: “There has been promising news

on the benefits of pomegranate juice in the fight against prostate cancer. Is this really true?” summarized study

results showing the effect of POM Juice on extending PSA doubling times (the Pantuck Phase II Prostate Cancer

Study (2006)). (CX0473 (Compl. Ex. E-8 at 09:05)). The answer went on to state that “[a] new study is underway

to more fully investigate the potential of POMx to extend PSA doubling time” and quoted Dr. Heber, identified

as “Director of UCLA's Center for Human Nutrition,” as commenting, “The most abundant and most active

ingredients in pomegranate juice are also found in POMx. Basic studies in our laboratory so far indicate that POMx

and pomegranate juice may have the same effects.” The foregoing quotation was italicized. (CX0473 (Compl.

Ex. E-8 at 09:05)).

410. In April 2009, the response to the FAQ, “Dosage: How much POMx should I take?” stated: “Whether you

choose pills or liquid, it is important to remember that to reap POMx's full health benefits: you must take it every

day.” (CX0473 (Compl. Ex. E-8 at 11:03)).

(iii) Pomegranatetruth.com

411. Based on the overall, common-sense, net impression of the pomegranatetruth.com website, including the

“backed by science” and “heart health-emerging science” sections and links therefrom, a significant minority of

consumers, acting reasonably in the circumstances, would interpret the pomegranatetruth.com website as claiming

that drinking eight ounces of POM Juice daily treats, prevents, or reduces the risk of heart disease, and that these

effects are clinically proven, as explained more fully below. (CX0473 pomegranatetruth.com (Compl. Ex. E-1);

F. 412-414)).

412. In April 2009, the home page of pomegranatetruth.com stated or represented that POM is 100% authentic

pomegranate juice, obtained through a unique process, and is the only pomegranate juice “backed by $25 million in

medical research” including “clinical studies” documenting its benefits, including heart benefits, prostate health,

and “better erectile function.” Each subsection contained a “read more” link. This page displayed the caduceus

symbol next to the “backed by science” reference. (CX0473 (Compl. Ex. E-1 at 00:10)).

413. The linked “Backed By Science” page on the pomegranatetruth.com website proceeded to introduce the

“medical results” on POM Juice, dividing into subsections on “Heart Health,” “Prostate Health” and “Erectile

Dysfunction.” The “Heart Health” section provided a “read more” link. (CX0473 (Compl. Ex. E-1 at 01:15)).

414. The linked “heart health” page on the pomegranatetruth.com website contained the headline “Heart Health

— Emerging Science.” The text advises the reader that “heart disease” is a leading killer of men and women

in the United States, that “atherosclerosis,” which is defined for the reader as too much “plaque,” is a leading

factor in “heart attacks” and the role of antioxidants in reducing LDL (defined as “bad” cholesterol) oxidation.

The text then invites the reader who wants to learn more about consumption of POM and cardiovascular health

to review research studies on the effects of pomegranate on myocardial perfusion, reduction of carotid intimamedia thickness, blood pressure, and LDL oxidation; and reducing systolic blood pressure. This page draws a

clear connection for the reader between “heart health” and “heart disease,” and between the effects shown by the

studies and the prevention, treatment or reduction of the risk of heart disease. (CX0473 (Compl. Ex. E-1 at 01:45)).
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*51 415. CX0473 Compl. Ex. E-1 does not show the content of the “prostate” page or the “erectile health” page,

referred to in F. 413.

iv. Press releases

(a) January 2003 Press Release (CX0013)

416. POM issued a press release in January 2003 titled “Consumer Demand for POM Wonderful's

Refrigerated All-Natural Pomegranate Juice Grows as the Health Benefits of Pomegranate Juice Become

Recognized.” (CX0013 at 0002-05). A copy of this press release is reprinted in the Appendix to this Initial

Decision. (Appendix at 94-97).

417. Based on the overall, common-sense, net impression of CX0013, a significant minority of reasonable

consumers would interpret this press release as claiming that drinking eight ounces of POM Juice daily treats,

prevents, or reduces the risk of heart disease, by reducing arterial plaque, and that the effects have been clinically

proven. (CX0013 at 0002-05; F. 418-420).

418. This press release had the subtitle, “Scientific support indicates that drinking pomegranate juice provides the

body with an active source of antioxidants and shows promise against cardiovascular disease.” (CX0013 at 0002).

419. This press release further states or represents that “cardiovascular diseases rank as America's No. 1 killer,”

and that 61.8 million Americans have some form of “cardiovascular disease such as diseases of the heart, high

blood pressure, and hardening of the arteries.” This release further states that “[m]edical research shows that daily

consumption” of eight ounces of POM Juice “confers heart health benefits by lessening factors that contribute to

atherosclerosis,” which is defined for the reader as “plaque in the arteries.” (CX0013 at 0002).

420. A paragraph titled “Effects on Heart Health” asserts that “[n]ew research is showing that antioxidants

can play a highly beneficial role in reducing one of the major risk factors in heart disease: atherosclerosis

(plaque in the arteries),” and explains the connection between “progression of atherosclerosis,” “oxidation of

LDL cholesterol” and “adhesion of LDL molecules” to the blood vessel. The paragraph further explains that (1)

“one human study” showed that drinking eight ounces of POM Juice for two weeks “lowered” LDC oxidation,

“clumping and adhesion” and (2) an “additional human study showed that consuming pomegranate juice reduces ...

ACE (angiotensin converting enzyme)” which “lessens the progression of atherosclerosis.” “Pomegranate juice

inhibited ACE by 36% after two weeks of juice consumption” and a “5% decrease in systolic blood pressure ...

a known risk factor for atherosclerosis.” (CX0013 at 0003).

(b) September 2005 Press Release (CX0044)

421. POM issued a press release in September 2005 titled, “Pomegranate Juice May Affect the Progression of

Coronary Heart Disease,” which highlighted the results of the Ornish MP Study (2005). (CX0044 at 0001). A

copy of this press release is reprinted in the Appendix to this Initial Decision. (Appendix at 98-99).

*52 422. Based on the overall, common-sense, net impression of CX0044, a significant minority of reasonable

consumers would interpret this press release as claiming that drinking eight ounces of POM Juice daily treats,

prevents, or reduces the risk of heart disease, by improving blood flow to the heart, and that clinical studies prove

these effects. (CX0044 at 0001; F. 423-427).
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423. This press release stated that “Men and women with coronary heart disease who drink one glass of

pomegranate juice daily may improve blood flow to their heart, according to a new study.” (CX0044 at 0001).

424. This press release described “the first randomized, double-blind, placebo-controlled trial showing that

pomegranate juice may affect the progression of coronary heart disease, which is the #1 cause of death in the U.S.

and in most of the world” and that “results ... [would] be published in ... the American Journal of Cardiology, one

of the leading peer-reviewed cardiology journals.” (CX0044 at 0001).

425. This press release described the study as involving 45 “patients” with “coronary heart disease” having

“reduced blood flow to the heart” and reported that the results showed “blood flow to the heart improved” in those

drinking a daily glass of pomegranate juice, but showed worsening in the comparison group. (CX0044 at 0001).

426. The press release explained that “[p]omegranate juice from POM Wonderful was used in this

study.” (CX0044 at 0002).

427. Dr. Ornish, identified as senior author of the referenced study (F. 424), founder of the Preventive Medicine

Research Institute, and clinical professor of medicine at UCSF, is quoted as stating that although the study sample

was “relatively small,” “the strength of the design and the significant improvements in blood flow to the heart

observed after only three months suggest that pomegranate juice may have important clinical benefits in those

with coronary heart disease” and that “[a]lso, it may help to prevent it.” In the context of Dr. Ornish's entire

statement, and in the context of the press release as a whole, the reference to a small sample, and use of words

“suggest” and “may have” do not materially modify the overall net impression from the press release described

in F. 422. (CX0044 at 0002).

(c) July 2006 Press Release (CX0065)

428. POM issued a press release in July 2006 titled, “POMx, a Highly Concentrated Form of Healthy Pomegranate

Antioxidants, Becomes Available to Consumers for the First Time.” (CX0065 at 0001-02). A copy of this press

release is reprinted in the Appendix to this Initial Decision. (Appendix at 100-101).

429. Based on the overall, common-sense, net impression of CX0065, a significant minority of reasonable

consumers would interpret this press release as claiming that that drinking eight ounces of POM Juice or taking

one POMx Pill daily, treats prostate cancer by prolonging PSADT and that these effects have been demonstrated

by clinical studies. (CX0065 at 0001-02; F. 430-431).

*53 430. This press release discussed research published by the American Association for Cancer Research

“indicat[ing] that a daily pomegranate regimen has a positive effect for men with prostate cancer” and that

“[s]pecifically, drinking 8 ounces of POM Wonderful pomegranate juice daily prolonged post-prostate surgery

PSA doubling time from 15 to 54 months (Clinical Cancer Research, July 1, 2006). PSA is a protein marker for

prostate cancer and the faster PSA levels increase in the blood of men after treatment, the greater their potential

for dying of prostate cancer.” (CX0065 at 0002).

431. This press release represented that study results using POM Juice are applicable to POMx, by quoting Dr.

Heber, identified as “Professor of Medicine and Director, UCLA Center for Human Nutrition,” as stating, “[b]asic

studies indicate that the effects of POMx and POM Wonderful pomegranate juice on prostate cancer are the same.

The most abundant and most active ingredients in pomegranate juice are also found in POMx.” (CX0065 at 0002).
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(d) June 2007 Press Release (CX0128)

432. POM issued a press release in June 2007 titled, “POM Wonderful 100% Pomegranate Juice May Improve

Mild to Moderate Cases of Erectile Dysfunction, Study Finds.” (CX0128 at 0002-04). A copy of this press release

is reprinted in the Appendix to this Initial Decision. (Appendix at 102-104).

433. Based on the overall, common-sense, net impression of CX0128, a significant minority of reasonable

consumers would interpret this press release as claiming that drinking eight ounces of POM Juice treats erectile

dysfunction, and that this effect has been demonstrated by clinical studies. (CX0128 at 0002-04; F. 434-439).

434. This press release stated, “[r]esearch shows 8 ounces a day of POM Wonderful 100% Pomegranate Juice

may help the management of erectile dysfunction” and “[a]ccording to a pilot study released in the International

Journal of Impotence Research (http://www.nature.com/ijir), POM Wonderful 100% Pomegranate Juice was

found to have beneficial effects on erectile dysfunction (ED), a disorder that affects 1 in 10 men worldwide and

10 to 30 million men in the United States alone.” (CX0128 at 0002).

435. This press release describes the study as a “randomized, placebo-controlled, doubleblind, crossover pilot

study” on the “efficacy of pomegranate juice,” and notes that “to qualify” for the study, among other things, the

“participants had to experience mild to moderate ED for at least 3 months.” The press release defined “mild” and

“moderate” ED in relation to the extent of the “decreased ability to get and keep an erection.” (CX0128 at 0002).

436. This press release reported the results as showing that “[f]orty-seven percent of the subjects reported that

their erections improved with POM Wonderful Pomegranate Juice.” (CX0128 at 0003).

437. The press release attributed the study results of improved erections to “enhance[d] blood flow,” which is an

effect of “potent pomegranate antioxidants,” noting that in “previously published medical studies, pomegranate

juice has been shown to enhance blood flow.” (CX0128 at 0003).

*54 438. The press release disclosed that the “study did not achieve overall statistical significance”; however, in

the context of the press release as a whole, this disclosure does not materially modify the overall net impression

described in F. 433. (CX0128 at 0002-04).

439. Use of the phrase, “may help,” in the overall context of this press release, is insufficient to modify the net

impression of the press release as a whole, described in F. 433. (CX0128 at 0002-04).

b. Alleged efficacy claims

(a) CX0031 (“Floss your arteries. Daily”)

440. The advertisement identified as CX0031 (Floss your arteries. Daily) was disseminated on or about December

1, 2004. (CX0031at 0001-02).

441. CX0031 is reprinted in the Appendix to this Initial Decision. (Appendix at 105).

442. POM first ran this advertisement in 2004 and stopped running it that same year. The “Floss your arteries”

headline, image and body copy have not run as part of any advertisement since 2004. (Tupper, Tr. 2995-96).
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443. Based on the overall, common-sense, net impression of the advertisement, a significant minority of

consumers, acting reasonably under the circumstances, would interpret CX0031 to contain the message that

drinking eight ounces of POM Juice daily treats, prevents or reduces the risk of heart disease, by reducing arterial

plaque. (CX0031 at 0001; F. 444-445).

444. This advertisement draws a connection between the consumption of POM Juice and the prevention, treatment

or reduction of the risk of heart disease, through statements and/or representations that (1) POM Juice has more

antioxidants than other drinks; (2) antioxidants fight free radicals; (3) free radicals cause “artery clogging plaque”;

(4) consumption of POM Juice “can reduce plaque by up to 30%!”; and (5) “Clogged arteries lead to heart trouble.

It's that simple. That's where we come in.” (CX0031 at 0001).

445. The headline, “Floss your arteries. Daily,” is clearly an exaggeration which would not be taken literally;

however, in the context of this advertisement, the headline contributes to the overall net impression described in

F. 433. (CX0031 at 0001).

446. An implied claim that consuming POM Juice is “clinically proven” to prevent, treat, or reduce the risk of heart

disease is not reasonably clear or conspicuous on the face of the advertisement. A review of the advertisement

alone, considering all its elements, does not lead to a confident conclusion that a significant minority of reasonable

consumers would interpret CX0031 as claiming that POM Juice is “clinically proven” to prevent, treat or reduce

the risk of “heart disease.” (CX0031 at 0001).

447. Among other things, in the context of this advertisement, the language that POM Juice “can” reduce plaque

by “up to 30%” is qualified and non-definitive, and the citation to a study appears in a small print footnote, which

states: “Aviram, M. Clinical Nutrition, 2004. Based on a clinical pilot study.” (CX0031 at 0001).

*55 448. Having fully examined CX0031 in its totality, and having further considered any extrinsic evidence in

the record pertaining thereto (see Section II. E. 2, infra), the preponderance of the evidence fails to demonstrate

that CX0031 conveys a claim that drinking eight ounces of POM Juice daily is “clinically proven” to prevent,

treat, or reduce the risk of heart disease. (CX0031 at 0001; F. 446-447).

(b) CX0033 (“Life Support”)

449. CX0033 (“Life Support”) is an advertisement for POM Juice that was disseminated on or about December

30, 2004 in Rolling Stone magazine, and on or about February 1, 2005 in Details magazine. (CX0033 at 0001-02).

450. CX0033 is reprinted in the Appendix to this Initial Decision. (Appendix at 106).

451. The advertisement's headline is “Life Support,” next to a large image of a POM Juice bottle hanging upside

down on a pole, with the juice running through a tube at the bottom of the bottle, in a manner reminiscent of an

intravenous line. (CX0033 at 0001).

452. The body copy of this advertisement juxtaposes the statements and representations that (a) POM Juice

possesses “more ... antioxidants” than other drinks; (b) antioxidants “fight hard” against free radicals that “can

cause heart disease”; and (c) if you drink POM Juice daily, “you'll be on life support — in a good way.” (CX0033

at 0001).

453. Through the language and images described in F. 451 and F. 452, CX0033 draws a connection for the reader

between consuming POM Juice and efficacy for heart disease. (CX0033 at 0001).
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454. In the context of this advertisement, the reference to POM Juice as “refreshing” and “delicious” does not

materially alter the overall message conveyed. (CX0033 at 0001; F. 453, 455).

455. Based on the overall, common-sense, net impression of CX033, a significant minority of reasonable

consumers, would interpret CX0033 to be claiming that drinking eight ounces of POM Juice daily prevents or

reduces the risk of heart disease. (CX0033 at 0001; F. 451-454).

(c) CX0034 (“Amaze your cardiologist”)

456. The POM Juice advertisement identified as CX0034 (“Amaze your cardiologist”) was disseminated in

Prevention magazine in February 2005. (CX0034 at 0001-02).

457. CX0034 is reprinted in the Appendix to this Initial Decision. (Appendix at 107).

458. This advertisement stopped running in 2005. (Tupper, Tr. 2996-97).

459. The headline of the advertisement is “Amaze your cardiologist.” The headline is juxtaposed to an image of

a POM Juice bottle with electrocardiogram (EKG) leads attached to it, in the manner of a patient having a heart

exam. (CX0034 at 0001).

460. The body copy of CX0034 includes the statements or representations: (a) “Ace your EKG: just drink 8 ounces

of delicious POM Wonderful Pomegranate Juice a day”; (b) POM Juice has more “antioxidants” than other drinks;

(c) antioxidants fight free radicals that “can cause ... artery clogging plaque”; (d) a glass of POM Juice a day “can

reduce plaque by up to 30%!”; and (e) “your cardiologist will be amazed.” (CX0034 at 0001).

*56 461. The advertisement draws a clear connection between consumption of POM Juice and reduction of

arterial plaque. (CX0034 at 0001).

462. The advertisement draws a further connection between reduction of arterial plaque and effectiveness for

heart disease through the juxtaposition of (1) the dressed bottle image undergoing an EKG (F. 459) and (2) the

references to pleasing “your cardiologist” with positive EKG results. (CX0034 at 0001).

463. Based on the overall, common-sense, net impression of this advertisement, a significant minority of

consumers, acting reasonably under the circumstances, would interpret CX0034 to contain the message that

drinking eight ounces of POM Juice daily treats, prevents, or reduces the risk of heart disease, by reducing arterial

plaque. (CX0034 at 0001; F. 459-462).

464. The depiction of the POM Juice bottle with an EKG, even if itself humorous or not to be taken literally, does

not materially alter the message conveyed by the advertisement. (CX0034 at 0001; F. 463).

465. An implied claim that consuming POM Juice is “clinically proven” to prevent, treat, or reduce the risk of heart

disease is not reasonably clear or conspicuous on the face of the advertisement. A review of the advertisement

alone, considering all its elements, does not lead to a confident conclusion that a significant minority of reasonable

consumers, would interpret CX0034 as claiming that POM Juice is “clinically proven” to prevent, treat or reduce

the risk of “heart disease.” (CX0034 at 0001).
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466. Among other things, in the context of this advertisement, the language that POM Juice “can” reduce plaque

by “up to 30%” is qualified and non-definitive, and the citation to a study is appears in a small print footnote,

which states: “Aviram, M. Clinical Nutrition, 2004. Based on a clinical pilot study.” (CX0034 at 0001).

467. In the context of this advertisement, the fact that the advertisement cites studies in connection with the

arterial plaque representation is not enough to conclude, based on the face of the advertisement alone, that the

advertisement claims POM Juice is clinically proven to prevent, treat, or reduce the risk of heart disease, including

by reducing arterial plaque. (CX0034 at 0001).

468. Having fully examined CX0034 in its totality, and having further considered any extrinsic evidence in the

record pertaining thereto (see Section II.E.2, infra), the preponderance of the evidence fails to demonstrate that

CX0034 conveys a claim that POM Juice is “clinically proven” to prevent, treat, or reduce the risk of heart disease,

including by reducing arterial plaque. (CX0034 at 0001; F. 465-467).

(d) CX0036 (“Cheat Death”)

469. In 2005 and 2006, POM disseminated a POM Juice advertisement with the headline, “Cheat Death.” The

advertisement ran in Rolling Stone magazine in March, June, and July 2005; in Prevention magazine in May 2005;

and in Fitness magazine in January 2006. (CX0036 at 0001-02).

*57 470. CX0036 is reprinted in the Appendix to this Initial Decision. (Appendix at 108).

471. The headline, “Cheat Death,” is juxtaposed to a large image of the POM Juice bottle with a noose around

the bottle's neck. (CX0036 at 0001).

472. The text of CX0036, which is brief, includes the statement that POM Juice “can help prevent” “heart

disease.” (CX0036 at 0001).

473. This “Cheat death” advertisement, with the above-quoted body copy that POM “can help prevent” certain

diseases stopped running in or around 2005. (Tupper, Tr. 2987-90).

474. Based upon the overall, common-sense, net impression of CX0036, particularly the statement that

consumption of POM Juice “can help prevent ... heart disease,” CX0036 would convey to a significant minority

of reasonable consumers, a claim that that drinking eight ounces of POM Juice daily reduces the risk of heart

disease. (CX0036 at 0001; F. 471-473).

475. In the context of this advertisement, use of the qualifying phrase “can help” does not alter the overall, common

sense, net impression of CX0036 set forth in F. 474.

476. The headline and noose imagery, even if constituting humor or hyperbole, does not, in the context of the

entirety of the advertisement, materially detract from the overall net impression of the advertisement, as described

in F. 474.

2. Extrinsic evidence regarding advertisement interpretation

a. Summary of expert opinions
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i. Respondents' expert Dr. Butters

477. Dr. Butters offered his opinion as a linguistics expert on the meanings of Respondents' advertisements.

(Butters, Tr. 2816-17).

478. Linguistics is the study of human language in all its forms and manifestations. (Butters, Tr. 2813). Linguistics

encompasses a number of often intersecting scientific subfields, including semantics, the study of word and

sentence meanings; pragmatics, the study of how such meaning is affected by nonlinguistic contexts; and

semiotics, the study of extra-linguistic and paralinguistic meaning systems that individuals assign to nonlinguistic

signs, such as pictures, colors, visual patterns, and icons. (PX0158 (Butters Expert Report at 0006-07)).

479. To draw his conclusions in this case, Dr. Butters applied all the subdivisions of linguistics, including

semantics, pragmatics, and semiotics, and considered the nature of the product advertised, as part of the overall

context for the advertisement. (Butters, Tr. 2814-15, 2817-18).

480. Dr. Butters reviewed an extensive number of POM advertisements, including the advertisements included

as exhibits to the Complaint and representative samples of other advertisements admitted into evidence. (PX0158

(Butters Expert Report at 0008); Butters, Tr. 2817, 2847).

481. Dr. Butters offered opinions on Respondents' advertising in general, and also offered opinions on the

meanings of many of the Challenged Advertisements in this case. (PX0158 (Butters Expert Report)).

482. In summary, Dr. Butters opined that the Challenged Advertisements do not expressly convey or convey by

implication that the Challenged Products prevent, reduce the risk of, or treat heart disease, prostate cancer or

erectile dysfunction, or that such alleged medical effects or benefits are scientifically established facts. (PX0158

(Butters Expert Report at 0003, 0042)).

*58 483. In Dr. Butters' opinion, none of Respondents' advertisements that he reviewed stated or implied that

POM products treated any disease. (Butters, Tr. 2822, 2825).

484. In linguistic terms, an advertisement “implies” a message if it is the meaning that a reasonable consumer

“takes away,” or infers, from the words and context of the advertisement. (Butters, Tr. 2826-2829).

485. Dr. Butters further opined, among other things, that the POM advertisements and POM communications he

reviewed, make no definitive health claims, beyond the general accepted notion that consuming fruit products as

part of an overall healthy diet is a healthy thing to do, including in order to reduce the risk of various diseases.

(PX0158 (Butters Expert Report at 0042)).

486. Dr. Butters expressed his opinion that, at most, Respondents' advertising conveys that pomegranate juice is a

healthy beverage; that POM products are high in antioxidants; that antioxidants are believed to fight free radicals

and promote health; and that preliminary research performed on POM products indicates potential beneficial

properties. (PX0158 (Butters Expert Report at 0003-04, 0043)).

487. In Dr. Butters' opinion, the POM advertisements he reviewed depend upon parody, exaggeration, and humor

to bring their message to the potential purchaser. (PX0158 (Butters Expert Report at 0033)).

488. In Dr. Butters' opinion, the use of humor and parody in the advertisements work to “block” any inference

that the advertisements are “intended to make definitive health claims” with respect to disease. (PX0158 (Butters

Expert Report at 0004)).
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489. Dr. Butters opined that hyperbole and humor block literal interpretation of such headings as “I'm off to save

prostates” because these are absurd terms which would not be viewed as making disease claims. (Butters, Tr.

2958; PX0158 (Butters Expert Report at 0004)).

490. In drawing his conclusions, Dr. Butters relied, in part, on the use of such words as “promising,” “pilot

studies,” or “preliminary results” and that the advertisements generally encourage those reading and hearing the

advertisements to investigate the research and draw their own conclusions. (PX0158 (Butters Expert Report at

0003-04, 0043)).

491. In Dr. Butters' opinion, what people might infer with respect to a food product might be different than what

they might infer with respect to a drug. (Butters, Tr. 2818).

492. In Dr. Butters' opinion, an advertisement promoting the consumption of food is far less likely to be interpreted

by a reasonable consumer as conveying a treatment claim, than an advertisement promoting a drug. (Butters, Tr.

2825; see also Butters, Tr. 2818).

493. Dr. Butters analyzed the Challenged Advertisements from the perspective of the ordinary adult user of the

English language in America. (Butters, Tr. 2816-17, 2831-32).

494. Dr. Butters did not take into account education or income level of the viewer of an advertisement, or whether

the advertisement viewer was concerned about health issues. (Butters, Tr. 2832-34).

*59 495. Dr. Butters stated that his conclusions about the Challenged Advertisements would be no different if

analyzed from the perspective of more educated, affluent people, who are concerned about their health. (Butters,

Tr. 2829-30).

496. In Dr. Butters' opinion, the phrase, “I'm off to save prostates” could be interpreted by outliers (i.e., viewers

that are not ordinary or reasonable) to mean protect or rescue from disease but that interpretation is unlikely.

(Butters, Tr. 2898; PX0350 (Butters, Dep. at 125)).

497. Dr. Butters stated that use of the term “may” would not cause a reasonable person to believe that the product

will produce that result. (Butters, Tr. 2822-23).

498. In Dr. Butters' opinion the representation that POM Juice will “fight for” “cardiovascular, prostate, erectile

health” does not imply that the product will “treat cardiovascular, prostate, and erectile disease, or even give you

cardiovascular, prostate, and erectile health.” Dr. Butters further opined that a closer possible inference is that

pomegranate juice “improves your odds of maintaining” health in those areas, in a general way like any other food

that is good for you, and to this extent, the language implies some kind of health benefit. (Butters, Tr. 2885-86,

2888; see also Butters, Tr. 2893 (phrase “fight for” “doesn't necessarily mean that you are going to win it”).

499. Dr. Butters acknowledged that a reasonable viewer could take away from CX0016 (“Drink and be healthy”)

that pomegranate juice, in general, and POM Wonderful, in particular, can help to reduce the risk of heart disease.

(Butters, Tr. 2929-30).

500. According to Dr. Butters, a reasonable viewer could not take away from the entire advertisement comprising

CX0016 “Drink and be healthy” that pomegranate juice, in general, and POM Wonderful in particular, will treat

atherosclerosis. (Butters, Tr. 2930).
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501. In Dr. Butters' opinion, CX0274/1426 Ex. C (“I'm off to save PROSTATES”), could communicate to viewers,

among other things, that POM Juice is protecting or defending prostates from disease. (Butters, Tr. 2899-2901).

502. Regarding CX0274/1426 Ex. C (“I'm off to save PROSTATES”), Dr. Butters opined that “the parodic method

of presentation [use of parody] is so frivolous that no definite or clear claims will be understood, beyond the

general notion that pomegranate juice is a good source of [anti]oxidants, and a healthy drink to include in one's

diet.” Dr. Butters has the same opinion with respect to CX0034 (“Amaze Your Cardiologist”); CX0031 (“Floss

Your Arteries”) and CX0351/CX0355 (“The Only Antioxidant supplement Rated X”). (PX0158 (Butters Expert

Report at 0019-22)).

503. Regarding CX0034 Dr. Butters opined that the headline, “Amaze Your Cardiologist” is hyperbolic and cannot

be taken literally. According to Dr. Butters, this language serves to “make explicit the theme of the importance of

heart health using advertising-cliché language.” (CX0034; PX0158 (Butters Expert Report at 0019-20)).

*60 504. Dr. Butters opined that CX0351 and CX0355 (both having the title, “The Only Antioxidant Supplement

Rated X”), convey the message that preliminary initial studies suggest that pomegranate extract, a strong source

of antioxidants, could help alleviate erectile dysfunction. (Butters, Tr. 2943).

505. Regarding CX0351 and CX0355 (“The Only Antioxidant Supplement Rated X”), Dr. Butters opined that

the advertisement only suggests that emerging science suggests that antioxidants are “critically important,” and

that “preliminary ... initial studies” suggest that pomegranate extract, a strong source of antioxidants, could help

alleviate erectile dysfunction. (Butters, Tr. 2943).

506. Regarding CX0260 (“Drink to Prostate Health”), Dr. Butters acknowledged that one inference that would

be drawn is that POM Juice might be beneficial for people who have had prostate cancer, because this is what

has been found in the preliminary medical study referenced in the advertisement. (Butters, Tr. 2943-44; PX0158

(Butters Expert Report at 0024); PX0350 (Butters, Dep. at 121-22)).

507. Regarding CX0260 (“Drink to Prostate Health”), Dr. Butters expressed the opinion that ordinary consumers

would not find that the advertisement communicates that POM Juice could treat, prevent, or reduce the risk of

disease. Dr. Butters further testified that there may be some outliers who may interpret the advertisement to make

such claims, but those outliers would, by definition, not be ordinary or normal. (PX0350 (Butters, Dep. at 121-25)).

508. Regarding CX0036 (“Cheat Death”), Dr. Butters opined that based on use of the words and phrases “can”

and “help” with respect to heart disease, which words have intrinsic meaning in the English language, reasonable

consumers would not interpret this advertisement to communicate that drinking eight ounces of POM Juice

prevents or reduces the risk of heart disease. (PX0350 (Butters, Dep. at 102-05)).

509. Regarding CX0103 (“Decompress”), Dr. Butters testified that it would be a gross exaggeration for anybody

to think that the image of a blood pressure cuff around the POM Juice bottle and the headline “Decompress” could

literally mean drink a glass of pomegranate juice and your blood pressure will go down. (Butters, Tr. 2933).

510. According to Dr. Butters, the headline “Decompress,” juxtaposed to the “blood pressure cuff” dressed bottle

image, and a sub-headline “the antioxidant power of pomegranate juice, would not likely communicate that

drinking POM Juice lowers blood pressure, and it would be far-fetched to interpret this text and imagery as making

a medical claim. (PX0350 (Butters, Dep. at 148-50)).
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511. Regarding CX0348 and CX0350 (“24 Scientific Studies”), Dr. Butters testified that a viewer of the “24

Scientific Studies” advertisement would find it reasonable to believe that the headline is accurate and that there

must be 24 scientific studies on POMx. (Butters, Tr. 2940).

ii. Complaint Counsel's rebuttal expert Dr. Stewart

*61 512. Complaint Counsel offered Professor David Stewart as a rebuttal witness to Dr. Butters. Dr. Stewart's

area of expertise is advertising, marketing, consumer behavior, and survey methodology. Dr. Stewart is not an

expert in linguistics, the subject of Dr. Butters' testimony. (Stewart, Tr. 3168-69).

513. Dr. Stewart was not asked by Complaint Counsel to conduct a facial analysis of the Challenged

Advertisements to opine on what the advertisements meant. Dr. Stewart was asked to read and critique Dr. Butters'

report, and to reach a conclusion as to whether or not he agreed with Dr. Butters' conclusions, and why. (Stewart,

Tr. 3169, 3226).

514. Dr. Stewart opined that “[I]t is not possible to determine that an advertisement does or does not communicate

certain implied messages simply from linguistic analysis.” (CX1295 (Stewart Expert Report at 0006)).

515. According to Dr. Stewart, linguistic analysis fails to take into account the individual characteristics of the

viewer and how that consumer processes information; it looks only at the advertisement stimulus. (Stewart, Tr.

3171-73).

516. According to Dr. Stewart, Dr. Butters' analysis ignores research related to how consumers use information,

process advertising messages, and make decisions in the market place. (CX1295 (Stewart Expert Report at 0006);

Stewart, Tr. 3170-71).

517. According to Dr. Stewart, well-educated, affluent, health-conscious consumers are more likely to be more

attentive to health claims and more likely to draw pragmatic inferences about the benefits of POM products.

(CX1295 (Stewart Expert Report at 0012-13)). However, Dr. Stewart defined a “pragmatic” inference as a

meaning that is neither express, nor implied by the advertisement, and may or may not even follow, logically.

(Stewart, Tr. 3227-28).

518. Dr. Stewart disagreed with Dr. Butters that a typical consumer would necessarily discern a difference between

“can” and “will.” According to Dr. Stewart, when viewing an advertisement the typical consumer is looking at the

totality of the advertisement including: the illustration, the headline, the text, and carrying away a net impression

based on all of that information. The potential meaning of “can” versus “will” is defined by its context, according

to Dr. Stewart. (Stewart, Tr. 3190-91).

519. Dr. Stewart disagreed with Dr. Butters over the effect of such words as “initial” or “pilot.” In Dr. Stewart's

opinion, the typical consumer would likely have little understanding of what “initial” or “pilot” means, particularly

in the context of being referred to as having been published in a major journal. In such circumstances, according

to Dr. Stewart, juxtaposing terms such as “initial” or “pilot” with mentions of a well-respected medical school

(UCLA), “leading universities,” reference to professional journals in which support of the claims is found,

reference to a Nobel laureate, and reference to the sum of money spent on research that is represented as supporting

the advertising claims (e.g., $25 million), have the effect of establishing the credibility of claims for the POM

products. (CX1295 (Stewart Expert Report at 0016-17); Stewart, Tr. 3191).
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*62 520. Dr. Stewart opined that the Bovitz Study (see subsection c, infra), which studied headlines from

billboard advertisements, contradicts the notion that humorous headlines, such as “Amaze your cardiologist” and

“Floss your arteries,” do not communicate any claims, as Dr. Butters concluded. (Stewart, Tr. 3202, 3204-06,

3230-31; see F. 497-489, 502-503).

b. Findings of fact regarding advertising interpretation, based upon testimony of Dr. Butters and Dr.

Stewart

521. More educated, affluent people, who are concerned about their health, are likely to be more discerning and

careful readers of an advertisement. (Butters, Tr. 2829-30).

522. Better educated people are more likely to better understand an advertisement. (Stewart, Tr. 3240).

523. According to the New Oxford Dictionary (“NOAD”) the meaning of “defend” (see CX0274/1426 Ex. C),

includes to “resist an attack made on (someone or something) and protect from harm or danger.” (Butters, Tr.

2899-2901).

524. In linguistic terms, “I'm off to save prostates” would not imply that a product will protect or rescue from

disease. (Butters, Tr. 2898; PX0350 (Butters, Dep. at 125)).

525. In linguistics terms, the word “may” is a shortened way of saying “may or may not.” (Butters, Tr. 2822-23).

526. According to an ordinary desktop dictionary, “can” does not mean “will.” (Butters, Tr. 2915).

527. Whether a consumer will discern a difference between “can” and “will” depends on the context and the

totality of the advertisement. (Stewart, Tr. 3190-91).

528. Some academic literature indicates that the use of qualifiers, such as “can,” “could,” “might,” or “up to”

“encourage the audience of the advertisements to infer that a stronger claim is intended than the one that is actually

entailed.” Dr. Butters disagrees with this assertion. (Butters, Tr. 2916-19; see also CX1295 (Stewart Expert Report

at 0016-17) (discussing study finding use of the word “may” rather than the stronger term “will” created greater

credence for the claim)).

529. In linguistic terms, to “prevent” a disease means to keep the disease from happening. (Butters, Tr. 2818).

530. In linguistic terms, the word “treat” means medical treatment. (Butters, Tr. 2825).

531. In linguistic terms, the phrase, “backed by research” totaling a certain dollar amount, such as used in

CX0475/1426 Ex. A, could be interpreted to mean there has been completed research with some results, or that

there has been a certain dollar amount of research done so far and that research is ongoing. (Butters, Tr. 2876-78).

532. In the field of linguistics, hyperbole is a term used to refer to extreme exaggeration, and is not meant literally.

(Butters, Tr. 2824).

533. Readers discount puffery and hyperbole because an advertisement using either, on its face, is an exaggeration;

however, the fact that puffery and hyperbole are not to be taken literally does not mean that they cannot convey

a claim that is serious. (Butters, Tr. 2824; Stewart, Tr. 3230).
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*63 534. Parody and humor have the effect of capturing the attention of the advertisement viewer, to help them

connect with the message in the printed portion of the advertisement. (Butters, Tr. 2866).

535. Humor can induce further processing of an advertisement and a search for further information. (Stewart,

Tr. 3229-30).

536. Contemporary speakers of American English would include “heart disease” within their understanding of

the meaning of “heart trouble.” (Butters, Tr. 2850-51).

537. Contemporary speakers of American English could interpret the phrase “erectile function” to relate to the

ability of men to achieve and maintain erections. Erectile function and the absence of erectile dysfunction are

closely related. (Butters, Tr. 2851 (discussing CX0351 and CX0355).

538. Contemporary speakers of American English could interpret the phrase “prostate health” to include the

condition of not being diseased. (Butters, Tr. 2851).

539. Contemporary speakers of American English could interpret the phrase “heart health” to include the condition

of not being diseased. (Butters, Tr. 2851).

540. In the proper context, a visual of an intravenous drip bottle could be a symbol for drugs and medicine.

(Butters, Tr. 2947).

541. The caduceus symbol, showing snakes curling around a staff, is a symbol that people associate with medicine.

(Butters, Tr. 2944). 3

542. Academic marketing and psychology literature indicate that the meaning of a particular communication really

resides in the recipient, not in the actual stimulus. Consumers are not simply passive recipients of messages but

are active processors. (Stewart, Tr. 3170).

543. To determine what a consumer would take away from the POM advertising, it is very important to know

the characteristics of the viewer of the advertisements, including prior beliefs and prior knowledge, and how the

consumer would process the information, and generally what the consumer brings to the viewing situation —

all of which are really important in understanding the totality of what people will take away from an advertising

message. (Stewart, Tr. 3171-73).

c. Bovitz Billboard Survey

544. In March 2009, at the request of Ms. Resnick, POM engaged the Bovitz Research Group (“Bovitz”) to design

a consumer survey to evaluate the relative effectiveness of the then-running “Super Hero” advertising campaign

compared to POM's earlier “Dressed Bottle” advertising campaign. (CX0286; CX1378 at 0049 (Kuyoomjian,

Ocean Spray Dep. at 191-92)).

545. The target POM consumer for purposes of the survey was identified for Bovitz as “Higher HH income $75k

+”, 25 to 64, concerned about their health and willing to buy premium, health products.” In recruiting participants,

the survey eliminated individuals with incomes below $75,000. Individuals who did not score high on a scale

measuring certain attitudes and lifestyle choices related to health and diet were also disqualified from participation.

(CX0286 at 0002-03; CX0369 at 0003).
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*64 546. The Bovitz Survey used a forced exposure methodology (i.e., showing the advertisement for which one

wants to ascertain the consumer takeaway, to the survey respondents) which, although not the typical, natural way

that consumers are exposed to advertising, is a valid method for a survey measuring advertising communication.

(CX0369 at 0004-07; Mazis, Tr. 2693-95; Reibstein, Tr. 2509-10).

547. The Bovitz Survey exposed survey respondents only to POM's billboard advertising. (Reibstein, Tr. 2572-73,

2575; Stewart, Tr. 3207, 3209; PX0295a15 at 0005-06).

548. The Bovitz Survey compared consumers' perceptions of the following ten billboard advertisements from

POM's Super Hero and Dressed Bottle advertising campaigns (hereinafter, “Bovitz Stimuli”), as follows:

Super Hero campaign advertisements:

Holy Health! $25 million in medical research.

I'm off to save PROSTATES!

100% PURE pomegranate juice to the rescue!

BACK OFF ... impostor juices!

Risk your health in this economy? NEVER!

Dressed Bottle campaign advertisements:

Cheat Death.

The Antioxidant Superpower.

Decompress.

Heart therapy.

Forever young.

(PX0295a15 at 0010-11).

549. The billboard advertisements from the Dressed Bottle campaign use humorous headlines and images.

(Stewart, Tr. 3205).

550. Each of the Bovitz Stimuli also included a tagline related to antioxidants, such as “The Antioxidant

Superpower” and the “The antioxidant power of pomegranate juice.” The Bovitz Stimuli contained no additional

text. (PX0225 at 0005-06).

551. In the Bovitz Survey, a total of 150 target consumers and 100 existing POM users were exposed to the

billboard advertisements from each campaign, identified in F. 544. (PX0225 at 0003-04).
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552. Four of the billboard advertisements described in F. 548 (i.e., “Heart therapy,” “Decompress,” “Cheat

death” and “I'm off to save prostates”) share headlines and imagery that appear in certain of the Challenged

Advertisements in this case. (See CX0109 at 0001 and CX0463 (“Heart therapy banner advertisement”), CX0103

at 0001 (“Decompress”), CX0036 at 0001 and CX0188 at 0001 (“Cheat death”), and CX0274 at 0001 and CX0466

(“I'm off to save PROSTATES!” banner advertisement)).

553. The headline of one test billboard included a reference to “$25 million in ... medical research,” (F. 548),

which reference appears in some of the Challenged Advertisements. (See, e.g., CX0274).

554. The participants were shown various advertisements, in a variety of configurations, and asked a series of

questions, including: “Other than trying to get you to buy the product, what do you think is the main idea” that

the advertisement “is trying to get across to you?” (CX0369 at 0005-11).

555. Fourteen percent of the general target audience and seventeen percent of POM Juice users in the Bovitz

Survey, when shown an advertisement picturing a POM Juice bottle inside a blood pressure cuff, with the headline

“Decompress” and a sub-headline “POM Wonderful Pomegranate Juice. The Antioxidant Superpower,” said the

ad's main idea was “helps/lowers blood pressure.” (PX0295a15 at 0011, 0018, 0046; Stewart, Tr. 3213-14).

*65 556. Other “main ideas” identified in the Bovitz Survey by those shown the billboard advertisement picturing

a POM Juice bottle inside a blood pressure cuff, with the headline “Decompress” and a sub-headline “POM

Wonderful Pomegranate Juice. The Antioxidant Superpower,” include: (1) 64% of the general population and

73% of the POM population stated that the “main idea” of the billboard was “healthy/health benefits/juice is good

for you”; (2) 16% of the general population and 20% of the POM population responded “antioxidants”; and (3) 6%

of the general population and 13% of the POM population said “calming/relieves stress/relaxing.” (PX0295a15

at 0018, 0046).

557. Forty-three percent of the general target audience and forty-eight percent of POM Juice users in

the Bovitz Survey, when shown an advertisement picturing a POM Juice bottle saying, “I'm off to save

PROSTATES!” and a sub-headline “The Antioxidant Superpower,” said the advertisement's main idea was “good

for prostates.” (PX0295a15 at 0010, 0017, 0045).

558. Other “main ideas” identified in the Bovitz Survey by those shown the billboard advertisement picturing a

POM Juice bottle saying, “I'm off to save PROSTATES!” and a sub-headline “The Antioxidant Superpower,”

include: (1) 31% of the general population and 48% of the POM population said the “main idea” of the “I'm off

to save PROSTATES!” billboard was “healthy/health benefits/juice is good for you” and (2) 12% of the general

population and 28% of the POM population said “antioxidants.” (PX0295a15 at 0017, 0045).

559. Twenty-two percent of the general target audience and thirty-one percent of POM Juice users in the Bovitz

Survey, who were shown an advertisement picturing a POM Juice bottle saying, “HOLY HEALTH! $25 million

in medical research” and a sub-headline “The Antioxidant Superpower,” said the advertisement's main idea was

“$25 million spent on research/research based.” (PX0295a15 at 0010, 0017, 0045).

560. Other “main ideas” identified in the Bovitz Survey by those shown the “HOLY HEALTH!” billboard

advertisements were: (1) 57% of the general population and 46% of the POM population said “healthy/health

benefits/juice is good for you;” (2) 12% of the general population and 9% of the POM population responded

“antioxidants.” (PX0295a15 at 0017, 0045).

561. According to Dr. Stewart, a test of headlines and images in the context of a billboard advertisement provides

some insight into understanding what messages were communicated by the image and the headline. Other text that
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is added to a lengthier print advertisement might modify the messages communicated by the image and headline.

(Stewart, Tr. 3205-06).

562. Bovitz Survey respondents were also exposed to all five tested advertisements from the “Super Hero”

campaign or all five tested advertisements from the “Dressed Bottle” campaign and asked: “Based on the ads

you just saw, what are the specific benefits, if any, of drinking POM Wonderful?” (CX0369 at 0008-09; Stewart,

Tr. 3214-16).

*66 563. Professor Reibstein testified that the question posed in F. 562 was a leading, biased question because it

directed the survey participants to select a “specific benefit” which pressures them to identify a “specific benefit”

even if they had not perceived a particular benefit. (Reibstein, Tr. 2515-16). Dr. Stewart testified that this question

was open-ended and not leading. (Stewart, Tr. 3216).

564. Of the survey respondents exposed to the five “Dressed Bottle” advertisements, which included the images

and headlines of the “Decompress” print advertisement (CX0103) and the “Heart Therapy” print and banner

advertisements (CX0109; CX0463), 38% of the general target audience said that a benefit of drinking POM Juice

was “good for your heart” and 21% said a benefit was “helps/lowers blood pressure.” (PX0225 at 0014; Stewart,

Tr. 3216-17).

565. Bovitz Survey respondents who were exposed to the five “Super Hero” advertisements, which included an

advertisement picturing a POM Juice bottle saying, “HOLY HEALTH! $25 million in medical research,” were

asked a close-ended question, “Based on the ads you just saw, which of the following do you think are true about

POM Wonderful?” Survey respondents were provided a multiple-choice list and told to select as many or as few

that applied. (CX0369 at 0010-11). Specifically, question 16 provided the following choices:

1. Backed by medical research

2. Is good for cardiovascular health

3. 100% pure pomegranate juice

4. Contains all natural ingredients

5. Is good for prostate health

6. Like “health in a bottle”

7. Contains naturally occurring antioxidants

8. Is the original pomegranate juice

9. Is good for you

10. Will help you stay healthy

11. Will help you live longer

12. Is better than other pomegranate juices

13. Has proven health benefits
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14. Tastes good

566. In response to Question 16, 63% of the general population and 78% of POM Juice users included the choice,

“has proven health benefits.” (PX0295a15 at 0033, 0034).

567. Complaint Counsel's expert, Dr. Stewart, acknowledged that because Question 16 was a closed-ended

question, there is the possibility of yea-saying, i.e., the tendency to give a yes or more socially desirable response

in an effort to be agreeable. (Stewart, Tr. 3218-19).

568. According to Dr. Reibstein, by providing respondents with a list of choices in response to Question 16 of the

Bovitz Survey, survey respondents were cued to select from attributes that they may not otherwise have thought

of, and do not have the option of attributes that do not appear on the list. This tends to inflate results. (Reibstein,

Tr. 2518-19).

569. According to Dr. Reibstein, the Bovitz Survey is methodologically flawed and unreliable because it had no

control and, thus survey respondents might have had preconceived perceptions about pomegranate juice before

being exposed to POM's billboard advertisements. (Reibstein, Tr. at 2510-11).

*67 570. Dr. Stewart testified he was “comfortable” with open-ended questions without a control, although he

also testified that, without a control, you cannot draw a firm inference that an advertisement had a particular effect.

(Stewart, Tr. 3241-42).

571. Dr. Reibstein opined that the Bovitz Survey is methodologically flawed and unreliable because the sample

size of only 100 POM users and 150 target consumers exposed to each category of advertisements was too small

to reach statistical significance at the 95% confidence level. (Reibstein, Tr. 2512-13).

572. None of the survey respondents in the Bovitz Survey answered that the main idea of the billboard

advertisements was prevention, risk reduction, or treatment of any specific disease. The most common “main

idea” communicated (at least 90%) was that POM Juice had general health benefits. (Reibstein, Tr. 2516-17;

PX0225 at 0012-13).

573. Dr. Reibstein testified that the Bovitz Survey is methodologically flawed and unreliable because Question

E (F. 574), which asked about health-related beliefs, resulted in accepting only recruits who were extremely

health-focused, rather than merely healthoriented. According to Dr. Reibstein, such respondents would be more

inclined to find health-oriented messages, particularly in light of the methodology of forced exposure and copy

test questions cueing health. (Reibstein, Tr. 2511-12).

574. Question E of the Bovitz Survey stated as follows:

Listed below are some statements that may or may not describe you. Using the scale provided, please indicate the

extent to which each of the following statements describes you.

(RANDOMIZE

ROWS)

Describes

me perfectly

Describes me well Describes me

somewhat

Describes me a little Does not

describe me at all
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I use my diet to

manage my health

5 4 3 2 1

High fiber foods are a

regular part of my diet

5 4 3 2 1

I regularly work out to

stay fit

5 4 3 2 1

I try to include plenty

of fruits and vegetables

in my diet

5 4 3 2 1

I believe that what I

eat can directly affect

my health

5 4 3 2 1

I am the first of

my friends to try

new gadgets and

technology

5 4 3 2 1

I prefer to watch

movies at home

instead of a theater

5 4 3 2 1

I am adjusting

my lifestyle to be

conscious of the

environment

5 4 3 2 1

I enjoy cooking and

trying new recipes that

I find online

5 4 3 2 1

I like to stay up on

current events

5 4 3 2 1

*68 To qualify for participation in the survey, respondents had to respond with a “5” or a “4” on the rating scale

with respect to at least three of the five health-related statements (i.e., Questions 1 through 5). (CX0369 at 0002).

3. Television interviews

575. On November 20, 2008, Mrs. Resnick appeared on NBC's The Martha Stewart Show. Martha Stewart invited

Mrs. Resnick to be interviewed on The Martha Stewart Show. (CX1426, Ex. E-6; L. Resnick, Tr. 137).

576. On February 19, 2009, Mrs. Resnick appeared on CBS' The Early Show in a segment on Cashing in on Ideas.

(CX472 at 0003).

577. On March 20, 2009, Newsweek published on its website two pages of excerpts from an interview with Mrs.

Resnick titled, “Striking Out On Your Own. Is now a good time to start a company?” (CX1426, Ex. F).
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578. On June 17, 2008, Mr. Tupper provided a television interview on the Fox Network Business Channel.

(CX1426, Ex. E-7; Tupper, Tr. 919). 4

4. Summary of findings on advertising claims

579. In determining whether Respondents disseminated advertisements and promotional materials making the

claims alleged in the Complaint, each of the Challenged Advertisements has been reviewed. Extrinsic evidence as

to how the Challenged Advertisements would be interpreted by a reasonable consumer has also been considered.

580. Respondents disseminated advertisements and promotional materials that impliedly represented either that

drinking eight ounces of POM Juice daily, taking one POMx Pill daily, and/or taking one teaspoon of POMx

Liquid daily, is clinically proven to treat, prevent, or reduce the risk of heart disease, by reducing arterial plaque,

lowering blood pressure, and/or improving blood flow to the heart, as alleged in paragraph 12 of the Complaint.

The following advertisements and promotional materials contain one or more of the foregoing representations:

• CX0016 (print advertisement) (prevent/reduce the risk only) (F. 293);

• CX0029 (print advertisement) (F. 299);

• CX1426 (Compl. Ex. I) (package insert) (F. 338);

• CX1426 (Compl. Ex. M) (POMx Heart Newsletter)(F. 346);

• CX0473 (Pomwonderful.com website: April 2009 (Compl. Ex. E-2); October 2009, December 2009 and January

2010 (F. 368, 380); Pompills.com website: April 2009 (Compl. Ex. E-8), January 2010 (Compl. Ex. E-9) (F. 387);

pomegranatetruth.com website (Compl. Ex. E-1)(F. 411));

• CX0013 (press release) (F. 417); and

• CX0044 (press release) (F. 422).

581. Respondents disseminated advertisements and promotional materials that impliedly represented either that

drinking eight ounces of POM Juice daily, taking one POMx Pill daily, and/or taking one teaspoon of POMx Liquid

daily, is clinically proven to treat, prevent or reduce the risk of prostate cancer by prolonging prostate-specific

antigen (“PSA”) doubling time, as alleged in paragraph 14 of the Complaint. The following advertisements and

promotional materials contain one or more of the foregoing representations:

*69 • CX0314 (magazine wrap) (F.310);

• CX0372 (magazine wrap) (F. 310);

• CX0379 (magazine wrap) (F. 310);

• CX0380 (magazine wrap) (F. 310);

• CX1426 (Compl. Ex. N) (POMx Prostate Newsletter) (F. 351);

• CX1426 (Compl. Ex. I) (package insert) (F. 331);
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• CX0473 (Pomwonderful.com website: April 2009 (Compl. Ex. E-2); October 2009, December 2009, and January

2010 (F 368, 380); Pompills.com website: April 2009 (Compl. Ex. E-8), January 2010 (Compl. Ex. E-9) (F. 387));

and

• CX0065 (press release) (F. 429).

582. Respondents disseminated advertisements and promotional materials that impliedly represented either that

drinking eight ounces of POM Juice daily, taking one POMx Pill daily, and/or taking one teaspoon of POMx

Liquid daily, is clinically proven to treat, prevent or reduce the risk of erectile dysfunction, as alleged in paragraph

16 of the Complaint. The following advertisements and promotional materials contain one or more of the foregoing

representations:

• CX0351 (print advertisement) (F. 325);

• CX0355 (print advertisement) (F. 325);

• CX0473 (Pomwonderful.com website: April 2009 (Compl. Ex. E-2); October 2009, December 2009, and January

2010 (F. 368, 380); Pompills.com website: April 2009 (Compl. Ex. E-8), January 2010 (Compl. Ex. E-9) (F.

387)); and

• CX0128 (press release) (treatment only) (F. 433).

583. Respondents disseminated advertisements and promotional materials that impliedly represented either that

drinking eight ounces of POM Juice daily, taking one POMx Pill daily, and/or taking one teaspoon of POMx

Liquid daily, treats, prevents or reduces the risk of heart disease, by reducing arterial plaque, lowering blood

pressure, and/or improving blood flow to the heart, without also representing clinical proof of these effects, as

alleged in paragraph 19 of the Complaint. The following advertisements contain one or more of the foregoing

representations:

• CX0031 (print advertisement) (F. 443);

• CX0033 (print advertisement) (F. 455);

• CX0034 (print advertisement) (F. 463); and

• CX0036 (print advertisement) (F. 474).

584. The findings described in F. 580-583 are based upon the overall, common-sense, net impression of the

advertisements themselves, and full consideration of any applicable extrinsic evidence. As to advertisements cited

in F. 580-583, the weight of the applicable extrinsic evidence fails to sufficiently contradict the overall, commonsense, net impression gleaned from the advertisements themselves.
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585. The following Challenged Advertisements were found to have made claims alleged in the Complaint, but the

preponderance of the evidence fails to prove that these advertisements made all the claims asserted by Complaint

Counsel. See Appendix A to Complaint Counsel's Post-hearing Brief. These advertisements and claims are:

CX0031 (“clinically proven” claim not found); CX0034 (“clinically proven” claim not found); CX0065 (press

release) (heart disease claim not found); CX0351 and CX0355 (prostate cancer and heart disease claims not found).

It is not reasonably clear from the face of the advertisements alone that a significant minority of consumers,

acting reasonably under the circumstances, would interpret these advertisements as making the identified claims.

A review of each of these advertisements, considering the interplay of all the elements of each such advertisement,

failed to allow a confident conclusion that a significant minority of reasonable consumers would interpret the

advertisements as making the identified claims. Among other reasons, the foregoing advertisements: do not

mention heart disease, prostate cancer, or erectile dysfunction; use vague, nonspecific, substantially qualified,

and/or otherwise non-definitive language; use language and/or images that, in the context of the advertisement,

are inconsistent with the alleged claim; and/or do not draw a sufficiently clear connection for the reader, such as

through associated explanatory text, between the health effects or study results referred to in the advertisements

and the diseases alleged in the Complaint. Moreover, applicable extrinsic evidence fails to demonstrate that these

advertisements make the identified claims.

*70 586. Based on a thorough review of all the Challenged Advertisements, none expressly (i.e., unequivocally

and directly) states that “drinking eight ounces of POM Juice daily” or “taking one POMx Pill daily,” or “taking

one teaspoon of POMx Liquid daily”(1) “treats,” “prevents,” or “reduces the risk” of “heart disease,” including by

reducing arterial plaque, lowering blood pressure, and/or improving blood flow to the heart, or that these effects

are “clinically proven”; (2) “treats,” “prevents” or “reduces the risk” of “prostate cancer,” including by prolonging

prostate-specific antigen doubling time, or that these effects are “clinically proven”; or (3) “treats,” “prevents,”

or “reduces the risk” of erectile dysfunction, or that these effects are “clinically proven.”

587. As to the Challenged Advertisements not identified in F. 580-583 as making the representations alleged in the

Complaint, after a thorough review it is not reasonably clear from the face of these advertisements that a significant

minority of consumers, acting reasonably under the circumstances, would interpret these advertisements as

making the claims alleged in the Complaint. A review of these advertisements, considering the interplay of

all the elements of each such advertisement, failed to allow a confident conclusion that a significant minority

of reasonable consumers would interpret these advertisements as making the claims alleged in the Complaint.

These advertisements, which are all print advertisements except where noted, are: CX0103; CX0109; CX0188,

CX0192; CX0260; CX0274; CX0475; CX0120; CX0122; CX0169; CX0180; CX0279; CX0280; CX0328;

CX0331; CX0337; CX0342; CX0348; CX0350; CX0353; CX0463 (banner advertisement) and CX0466 (banner

advertisement).

588. Among other reasons, the advertisements identified in F. 587: use language that is vague, non-specific,

substantially qualified, and/or otherwise non-definitive; use language and/or imagery that in the context of the

advertisements is inconsistent with the alleged claims; fail to mention specific diseases; and/or fail to draw a

sufficiently clear connection for the reader, such as through associated explanatory text, between health effects or

study results referred to in the advertisements and the diseases alleged in the Complaint.

589. As to the advertisements identified in F. 587, the weight of the applicable extrinsic evidence (see Section

II.E.2, infra) fails to demonstrate that these advertisements make the claims alleged in the Complaint.

590. Having fully considered each of the advertisements identified in F. 587, as well as any extrinsic evidence

pertaining thereto (see Section II.E.2, infra), the preponderance of the evidence fails to demonstrate that a
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significant minority of reasonable consumers would interpret these advertisements as making the claims alleged

in the Complaint.

*71 591. The evidence fails to show that CX0473 (pomegranatetruth.com website) made the prostate cancer

and erectile dysfunction claims alleged in the Complaint because the web capture of this website did not include

content pertaining to such claims. (F. 415).

F. Level of Required Substantiation

1. Types of studies

592. There are four study types for examining the relation between a food or nutrient and a disease outcome:

(a) in vitro studies; (b) animal studies; (c) human observational studies; and (d) human clinical studies. (CX1293

(Stampfer Expert Report at 0008)).

593. “Basic science” refers to test-tube, animal studies, and preclinical research. (Dreher, Tr. 528).

a. In vitro studies

594. In vitro studies are those where blood elements or cells are removed from the body and tested in a controlled

laboratory environment, such as a test tube. They are used to identify potential biologic mechanisms and generate

hypotheses for studies in humans. (CX1293 (Stampfer Expert Report at 0008); CX1291 (Sacks Expert Report

at 0015-16); see Melman, Tr. 1112). Human metabolism and disease processes are very complicated and cannot

be replicated in a petri dish, and therefore, many in vitro studies produce results that cannot be replicated in

humans. (CX1291 (Sacks Expert Report at 0015-16); Sacks, Tr. 1450; see also Stampfer, Tr. 725-26; deKernion,

Tr. 3063-64).

b. Animal studies

595. Animal studies are tools for identifying potential treatments, mechanisms, and side effects. Animals are not

the same as humans, either biologically or psychologically, and therefore, many findings of dietary or drug effects

in animals are not confirmed in human testing. (CX1291 (Sacks Expert Report at 0016); Sacks, Tr. 1451; Melman,

Tr. 1112-13; CX1289 (Melman Expert Report at 0011); see PX0355 (Ornish, Dep. at 66)).

596. Animal studies alone are not sufficient to show that a tested product will prevent or treat human disease.

(Sacks, Tr. 1451-52; Melman, Tr. 1112-13; CX1289 (Melman Expert Report at 0011); Goldstein, Tr. 2644;

PX0349 (Burnett, Dep. at 57, 112-13)).

597. Animal studies are very informative and provide for some clinical insights. (PX0349 (Burnett, Dep. at 111);

PX0352 (Goldstein, Dep. at 122-24); Goldstein, Tr. 2644; Heber, Tr. 2086, 2149; CX1352 (Heber, Dep. at 243);

Heber, Tr. 2086; 2149, 2182; PX0192 (Heber Expert Report at 0015, 0041-42, 0051-59). In an animal study,

researchers can isolate mechanisms of action and accomplish toxicity or safety testing, as well as examine specific

mechanisms by taking out their organs and cells, which cannot be done in humans. (PX0361 (Sacks, Dep. at

89-91). Results from such animal studies have potential for benefit of therapy at the human level. (PX0206 (Miller

Expert Report at 10-11, 13); Miller Tr. 2194; PX0349 (Burnett, Dep. at 112); Burnett, Tr. 2262-63; Heber, Tr.
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2086, 2149; CX1352 (Heber, Dep. at 243); Heber, Tr. 2086; 2149, 2182; PX0192 (Heber Expert Report at 0015,

0041-42, 0051-59).

*72 598. Although there are limitations to extrapolating from animal studies to human studies, studies on animals

have value in determining therapeutic efficacy. (PX0025 (Ornish Expert Report at 0007)).

599. Dr. Sacks, Complaint Counsel's cardiology expert, testified that he considers all levels of science in issuing

national guidelines for the prevention or treatment of cardiovascular disease. (PX0361 (Sacks Dep. at 71)).

Similarly, Complaint Counsel's erectile dysfunction expert, Dr. Melman, testified that based on the results of his

gene therapy erectile dysfunction product in an animal model, he was “personally satisfied” that it would also

work in humans. (PX0360 (Melman, Dep. at 56-57)).

c. Human observational studies

600. Human observational studies are large human studies that compare intake of various levels of nutrients (for

example, low vitamin C versus high vitamin C) with various endpoints, such as disease outcomes, over time.

(CX1293 (Stampfer Expert Report at 0008); Stampfer, Tr. 719; see Heber, Tr. 2168).

601. Human observational studies can support a conclusion that there is an association between a nutrient and

a disease of interest, but generally do not prove causation, due to the potential, even in well-designed studies,

for unidentified biases or inadequately controlled confounding factors. (CX1293 (Stampfer Expert Report at

0008-09); Stampfer, Tr. 720-21; see Sacks, Tr. 1418-19).

d. Human clinical studies

602. Human clinical studies are those in which investigators assign the exposure level to participant — meaning

that the investigators tell the subjects how much of a particular nutrient to consume, in contrast to observational

studies, where the investigators study existing exposure levels within a particular population. (CX1293 (Stampfer

Expert Report at 0009)).

603. There is a typical progression in human clinical studies, from exploratory research to randomized clinical

trials. (PX0025 (Ornish Expert Report at 0010, 0024) (“Science usually progresses when someone publishes a

study of a series of patients with a nonrandomized control group that shows an unprecedented finding which is

then replicated by one or more subsequent randomized controlled trials[;]” “[t]here is a logical progression in

science which often begins with a pilot study that has no control group”)).

604. Some researchers describe the progression of research in terms of “phases,” where: a Phase I trial tests

treatments in a small number of patients to find a safe dose; a Phase II trial tests the intervention in a larger number

of people to identify specific effects; a Phase III trial tests the treatment in a larger number of people, to compare

it to “standard treatment”; and a Phase IV trial tests a treatment in several hundred to thousands of people to

assess long-term safety and effectiveness. (CX1287 (Eastham Expert Report at 0009); CX1341 (Pantuck, Dep.

at 28-29); see also Burnett, Tr. 2262).

*73 605. Typically, researchers conduct pilot or exploratory studies. A pilot study is designed to investigate

whether there is any evidence of a treatment effect. Such research can reveal potential changes from an

intervention, allows the researchers to see if people can tolerate the intervention or if it causes unexpected side
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effects, and paves the way for more definitive research. (CX1338 (Padma-Nathan, Dep. at 87-88, 155); CX1193

at 0001; Melman, Tr. 1116; Stampfer, Tr. 747-48; CX1342 (Hill, Dep. at 45-48)).

606. Pilot studies are generally considered by scientists and clinicians in the scientific community to be valid,

accurate, and reliable studies. (CX1336 (Davidson, Dep. at 232-33); CX1342 (Hill, Dep. at 48-49, 53); CX1339

(Ornish, Dep. at 23); CX1358 (Aviram, Dep. at 17)).

607. A “pilot” study does not mean that it is not as scientifically valid as a larger study. (CX1339 (Ornish, Dep.

at 23, 119-20)). A small number of participants do not weaken the importance of the results, especially if they are

in agreement with in vitro, mechanistical studies and in animal models. (CX1358 (Aviram, Dep. at 18)).

608. A reason a researcher conducts a “pilot” study is because he or she is not certain how many subjects it will

take to adequately power the study. If there is no effect shown, then this allows the investigators to address any

concerns regarding the study. (CX1342 (Hill, Dep. at 46-48)).

2. Randomized clinical trials

609. Well-designed, well-conducted, randomized, double-blinded, placebo-controlled human clinical studies are

referred to by experts in the field of clinical testing as “RCTs.” (CX1291 (Sacks Expert Report at 10)).

610. It is standard practice, in human research, to begin with a protocol. (Stampfer, Tr. 760; Sacks, Tr. 1436-37;

Heber, Tr. 2044-45). A protocol describes the key features of a study, such as objectives, methodology, statistical

analysis plan, the definition of the p value (probability), and primary outcome variables (endpoints). (Sacks, Tr.

1436-37; Stampfer, Tr. 760; see Ornish, Tr. 2367). The purpose of identifying the primary outcomes in advance is

to prevent a researcher from using positive results and ignoring negative ones, resulting in bias. (Sacks, Tr. 1475;

CX1291 (Sacks Expert Report at 0021)).

611. A controlled study is one that includes a group of patients receiving the purported treatment (“treatment” or

“active” group) and a control group (“placebo” or “control” group). (CX1291 (Sacks Expert Report at 0011)). A

control group provides a standard by which results observed in the treatment group can be evaluated. (CX1287

(Eastham Expert Report at 0013)). A control group allows investigators to distinguish between real effects from

the intervention, and other changes, including those due to the mere act of being treated (“placebo effect”), the

passage of time, change in seasons, other environmental changes, and equipment changes (such as calibration

changes). (CX1291 (Sacks Expert Report at 0011); Burnett, Tr. 2265; Eastham, Tr. 1268; see CX1293 (Stampfer

Expert Report at 0009); Ornish, Tr. 2367). The control group should be approximately the same size and meet the

same criteria as the treatment group. (Eastham, Tr. 1268-69; CX1287 (Eastham Expert Report at 0013); CX1291

(Sacks Expert Report at 0011); Melman, Tr. 1095; CX1289 (Melman Expert Report at 0009)). It also should

receive the same measurements and attention from the researchers as the treatment group. (CX1291 (Sacks Expert

Report at 0011)).

*74 612. Randomization means assigning subjects to the active product group or the control group in a random

fashion, whether using a computer program, random number table, or coin toss. It is another way to control for

bias. (Burnett, Tr. 2264-65; CX1291 (Sacks Expert Report at 0011); CX1339 (Ornish, Dep. at 20); Eastham, Tr.

1266; Melman, Tr. 1096). It increases the likelihood that the treatment and control groups are similar in relevant

characteristics, so that any difference in the outcome between the two groups can be attributed to the treatment.

(CX1291 (Sacks Expert Report at 0011-12); CX1293 (Stampfer Expert Report at 0009); CX1287 (Eastham Expert

Report at 0012-13); CX1339 (Ornish, Dep. at 20) (“[B]y randomizing people, if there were some unknown factor

that was biasing your outcomes, it would be likely to be distributed across both groups”)). It also prevents the
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investigator from deciding who gets which treatment, which can introduce bias into the study. (CX1345 (deGroof,

Dep. at 62); Melman, Tr. 1096).

613. A placebo is an inactive product or treatment given to the control group, in lieu of the intervention being

tested. (Stampfer, Tr. 708; Eastham, Tr. 1267-68; Melman, Tr. 1094-95). For example, in a study of a pill, the

placebo would be a pill that looks like the intervention, but does not contain the active ingredient. (Stampfer, Tr.

708). A placebo should be identical, in all ways possible, to the active treatment. (CX1291 (Sacks Expert Report

at 0011); Melman, Tr. 1095). A double blind study, see F. 614, blinds participants and investigators as to whether

study participants are in the active or placebo group. (CX1293 (Stampfer Expert Report at 0009); Melman, Tr.

1095-96).

614. Blinding refers to steps taken to ensure that neither the study participants nor the researchers conducting the

outcome measurements are aware of whether a patient is in the active group or the control group. (CX1291 (Sacks

Expert Report at 0012); Melman, Tr. 1097).

615. Double-blinding, that is, blinding of both the patients and investigators, is optimal to prevent bias arising

from actions of the patients or investigators. (CX1293 (Stampfer Expert Report at 0009); Stampfer Tr. 708-09;

Eastham, Tr. 1267; Melman, Tr. 1098; CX1287 (Eastham Expert Report at 0013); see also Heber, Tr. 2044). In

some instances, the blinding of patients is not possible. A study that is unblinded can still have value. (Sacks, Tr.

1435-36; PX0361 (Sacks, Dep. at 104-05); Ornish, Tr. 2345; Eastham, Tr. 1327, 1339).

616. Once a randomized controlled trial is completed and all the data is collected, data for the control and

active treatment groups is compared through use of appropriate statistical analyses. (Eastham, Tr. 1272; CX1287

(Eastham Expert Report at 0014); CX1291 (Sacks Expert Report at 0012-13)). If the results of the treatment group

are statistically significant from those of the control group at the end of the trial, it can be concluded that the

tested product is effective. This analysis is called a between-group analysis. (CX1291 (Sacks Expert Report at

0012-13); Burnett, Tr. 2269).

*75 617. A within-group analysis, where a researcher compares the treatment group participants' “before” data to

their “after” data, has much less scientific value, because it relies on the assumption that without the intervention

there would have been no change in the study participants' condition. (Stampfer, Tr. 714).

618. Evaluating data from a clinical trial for statistical significance is the standard practice to demonstrate that

a study's hypothesis has been proven. (Burnett, Tr. 2269; CX1287 (Eastham Expert Report at 0014)). Statistical

significance is recognized as being attained if the statistical test for probability, referred to as the “p” value, is

less than or equal to 0.05 (p # 0.05), which means that there is only a 5 percent or less chance that the difference

between the treatment and placebo groups is due to chance. (CX1291 (Sacks Expert Report at 0012); Eastham,

Tr. 1273; Ornish, Tr. 2368; Melman, Tr. 1102-03; CX1289 (Melman Expert Report at 0010)). It eans that the

results demonstrated would occur no more than one time out of 20, and therefore, other causes of the result, such

as chance, are less likely as an explanation. (Stampfer, Tr. 710-11).

619. Statistical significance is an arbitrary convention in the context of studying a whole food. (Ornish, Tr. 2340,

2368; Goldstein, Tr. 2598-99 (choosing a significance level is technically an arbitrary task, and “in specific

situations a different value could be utilized”)).

620. Results that do not have a p-value of less than 0.05 can still evidence a clinically meaningful benefit that is

scientifically supportable. (PX0352 (Goldstein, Dep. at 108-09); Goldstein, Tr. 2599; PX0189 (Goldstein Expert

Report at 0013); PX0349 (Burnett, Dep. at 67, 138-39); Burnett, Tr. 2270-71; CX1350 (Liker, Dep. at 190-91);

PX0361 (Sacks, Dep. at 109); Sacks, Tr. 1608-09).
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621. Validated endpoints or surrogate markers are those outcomes that, while not direct endpoints, have been

shown to be so closely linked to a direct endpoint that a change in the surrogate marker is confidently predictive of

a change in the disease. (See CX1291 (Sacks Expert Report at 0013); see CX1287 (Eastham Expert Report at 0010)

(“Changes in a surrogate are expected to reflect changes in a clinically meaningful endpoint”)). Validated measures

or assessment tools are those that have been established as reliable through rigorous assessments involving a large

number of individuals. (Burnett Tr. 2266-67; Melman, Tr. 1100).

622. Certain validated measures, like the International Index of Erectile Function (“IIEF”), were originally

intended for pharmaceutical products and “not necessarily designed for a nutraceutical [a food product that

provides medical or health benefits].” (PX0352 (Goldstein, Dep. at 67-69); Goldstein, Tr. 2603-04, 2633).

623. Certain non-validated measures are very “informative and ... valuable to use in clinical studies.” (Burnett,

Tr. 2294).

*76 624. Clinical significance means that the treatment makes a real difference in a patient's life. (Melman, Tr.

1103; Eastham, Tr. 1274; PX0361 (Sacks, Dep. at 109)). A result may also be clinically significant even if it did not

reach statistical significance. (PX0352 (Goldstein, Dep. 108-09); Goldstein, Tr. 2599; PX0189 (Goldstein Expert

Report at 0013); PX0349 (Burnett, Dep. at 67, 138-39); Burnett, Tr. 2270-71; CX1350 (Liker, Dep. at 190-91).

A result may be statistically significant, but not clinically significant. (Melman, Tr. 1104; Eastham, Tr. 1274).

625. Replication is intended to ensure that the results obtained in one study are not due to chance. Even with

the safeguards contained in an RCT, the results contained in any one study may be due to chance or may not be

generalizable due to uniqueness of the study sample. (Sacks, Tr. 1446; CX1291 (Sacks Expert Report at 0014-15)).

3. Testimony from Complaint Counsel's experts on whether RCTs are required

a. Dr. Meir Stampfer

626. Dr. Stampfer provided the following opinion regarding the appropriate level of evidence of substantiation:

randomized, double blind, placebo-controlled trials are needed for nutrient supplements when they are used as

medical interventions to prevent or treat diseases. (CX1293 (Stampfer Expert Report at 0029)).

627. Dr. Stampfer testified that if there is a claim that a cause and effect relationship (causal link) between a nutrient

or food and a disease has been established, then one has to have evidence to back it up. (Stampfer, Tr. 830-31).

628. Dr. Stampfer testified that the level of scientific evidence required to support a claim depends on the claim

being made. (Stampfer, Tr. 830-31).

629. Dr. Stampfer explained that it is an efficacy claim to say that a product reduces the risk of a disease, but

it is not an efficacy claim to say that users of a product have a lower incidence of a particular disease. To state

that users of a product have a lower incidence does not mean that use of the product caused them to have a lower

incidence. (Stampfer, Tr. 798).

630. Dr. Stampfer further testified that a statement that studies indicate that a product lowers the risk of heart

disease and diabetes does not imply that a causal link is established. (Stampfer, Tr. 817).
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631. Dr. Stampfer testified that if the claim does not imply a causal link, for example, if the claim is that there is

some evidence to suggest the possibility that nuts may reduce the risk of diabetes, then evidence short of RCTs can

support that claim. (Stampfer, Tr. 830-31; CX1293 (Stampfer Expert Report at 0029-30) (it may be appropriate

to use evidence short of randomized clinical trials for crafting public health recommendations regarding nutrient

guidelines even when causality cannot be established, because everyone eats and the public should be given advice

based on the best evidence available. This advice should distinguish between recommendations based on good

evidence of a causal relation from those that are based on evidence that is suggestive but falls short of a firm

casual conclusion.)).

*77 632. Dr. Stampfer further testified that in a nutritional context, a hypothesis about disease causation can,

rarely, if ever, be directly tested in humans using the RCT design. (Stampfer, Tr. 831-32; PX0362 (Stampfer, Dep.

at 73, 99); CX1293 (Stampfer Expert Report at 0030) (long term trials of diet and disease outcomes are often

unfeasible due to the financial and participant burden required to perform such studies, but it is indisputable the

randomized clinical trial is the best study design that permits strong causal inference concerning the relationship

between an administered agent (whether drug or nutrient) and any specific outcome)).

633. Dr. Stampfer also testified, that the failure to act, in the absence of conclusive RCT evidence, increases the risk

of forgoing benefits to the public that might have been achieved with little risk and little cost and that one should

“definitely” make that potential benefit available to the public rather than withhold it. (Stampfer, Tr. 837-38).

634. In a recently published article titled “Evidence-based criteria in the nutritional context,” Dr. Stampfer opined

that the general principles of evidence-based nutrition “can provide a sufficient foundation for establishing nutrient

requirements and dietary guidelines in the absence of RCTs for every nutrient and food group.” (Stampfer, Tr. 831;

RX5007 at 483). Dr. Stampfer also opined that because RCT study designs may not be “available” (economically

or scientifically) for nutrients, “nutrient related decisions could be made at a level of certainty somewhat below

that required for drugs.” (RX5007 at 481).

635. Dr. Stampfer also stated in the article “Evidence-based criteria in the nutritional context” that some of

the intellectual fathers of evidence based medicine “stressed” that evidence based medicine was “not restricted

to randomized trials and meta-analyses.” (RX5007 at 483). Dr. Stampfer further stated that “certain features of

[evidence-based medicine] seem ill-suited to the nutrition context.” (RX5007 at 479). He also opined that “to fail

to act in the absence of conclusive RCT evidence increases the risk of forgoing benefits that might have been

achieved with little risk and at low cost.” (RX5007 at 481).

636. In the article “Evidence-based criteria in the nutritional context,” Dr. Stampfer noted that some of the

differences between the evaluation of drugs and nutrients are: “(i) medical interventions are designed to cure a

disease not produced by their absence, while nutrients prevent dysfunction that would result from their inadequate

intake; (ii) it is usually not plausible to summon clinical equipoise for basic nutrient effects, thus creating ethical

impediments to many trials; (iii) drug effects are generally intended to be large and with limited scope of action,

while nutrient effects are typically polyvalent in scope and, in effect size, are typically within the “noise” range of

biological variability; (iv) drug effects tend to be monotonic, with response varying in proportion to dose, while

nutrient effects are often of a sigmoid character, with useful response occurring only across a portion of the intake

range; (v) drug effects can be tested against a nonexposed (placebo) contrast group, whereas it is impossible and/

or unethical to attempt a zero intake group for nutrients; and (vi) therapeutic drugs are intended to be efficacious

within a relatively short term while the impact of nutrients on the reduction of risk of chronic disease may require

decades to demonstrate — a difference with significant implications for the feasibility of conducting pertinent

RCTs.” ‘28RX5007 at 479; PX0362 (Stampfer, Dep. at 78)).
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*78 637. Dr. Stampfer admitted that he has made public health recommendations about foods that were not

supported by RCTs. (Stampfer, Tr. 810, 813-14; PX0362 (Stampfer, Dep. at 173)).

b. Dr. Frank Sacks

638. Dr. Sacks provided the following opinion regarding the appropriate level of evidence of substantiation:

appropriately analyzed results of well-designed, well-conducted, randomized, double-blinded, controlled human

clinical studies, demonstrating significant changes in valid surrogate markers of cardiovascular health would be

necessary (a) to substantiate that a product, including a conventional food or dietary supplement, can treat, prevent

or reduce the risk of heart disease and/or (b) to support a claim that clinical studies, research, or trials prove that

a product treats, prevents or reduces the risk of heart disease. In addition, Dr. Sacks opined that at least two welldesigned studies, conducted by different researchers, and each showing strong results, are needed to constitute

reliable evidence. (CX1291 (Sacks Expert Report at 0010-11, 0014-15)).

639. Dr. Sacks testified that most scientists in the fields of nutrition, epidemiology and the prevention of disease

believe that at least two well-designed RCTs, conducted by independent researchers, and each showing strong

results, are needed to constitute reliable evidence that an intervention causes a result. (Sacks, Tr. 1446; CX1291

(Sacks Expert Report at 0014-15)).

640. Dr. Sacks testified that pomegranate juice has not been proven for safety and that double-blinded, placebocontrolled tests would be necessary to prove pomegranate juice to be safe. (Sack, Tr. 1534).

641. Dr. Sacks acknowledges that in some instances, such as studies on foods, the blinding of patients is not

possible, and that if a study becomes unblinded or does not have a placebo, it can still have value. (Sacks, Tr.

1435; PX0361 (Sacks, Dep. at 104-105, 111, 137)).

642. In an article titled “The Importance of Population-Wide Sodium Reduction as a Means to Prevent

Cardiovascular Disease and Stroke: A Call to Action From the American Heart Association” published in their

journal (Circulation. 2011 Mar 15;123(10):1138-43), Dr. Sacks, as one of the authors, wrote: “Some scientists still

question the evidence supporting population-wide sodium reduction. Common arguments include the absence of

a major trial with hard clinical outcomes. It is well-known, however, that such trials are not feasible because of

logistic, financial, and often ethical considerations.” (Sacks, Tr. 1561; PX0361a03). In writing about “financial

considerations” in this article, Dr. Sacks conceded that he meant the cost of conducting a major trial. (Sacks, Tr.

1561).

643. Dr. Sacks has never researched whether a single fruit, such as the pomegranate, has health benefits, but

instead has only studied “fruits and vegetables as a category.” (PX0361 (Sacks, Dep. at 54, 56)).

644. Dr. Sacks served as the Chairman of the Design and Analysis Committee for the DASH (“Dietary Approaches

to Stop Hypertension”) diet sponsored by the National Heart, Lung and Blood Institute, part of the National

Institute of Health. The DASH study was a multi-center study to look at the effect of fruits and vegetables in

lowering blood pressure and the effect of a total dietary approach in lowering blood pressure, including the

reduction of sodium intake. The DASH diet showed that diets high in fruits and vegetables, among other things,

substantially lowered blood pressure in subjects compared to the control group. (PX0361a03 at 002; PX0361

(Sacks, Dep. at 48-49); Sacks, Tr. 1417-18).
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*79 645. Dr. Sacks testified that you do not need RCTs to test the benefit of food categories that are included

in a diet already tested, like the DASH diet, which includes pomegranates. However, Dr. Sacks also opined that

you do need two RCTs to test pomegranate juice. (Sacks, Tr. 1546-47).

646. Dr. Sacks also testified that in vitro studies can be competent and reliable evidence of an agent's effect on a

particular mechanism. (Sacks, Tr. 1578; PX0361 (Sacks, Dep. at 123-24)).

647. Dr. Sacks further testified that there are common clinical recommendations today that have not been proven

by RCTs and that major trials with hard clinical outcomes are often not feasible because of the costs of conducting

them. (Sacks, Tr. 1559-61).

c. Dr. James Eastham

648. Dr. Eastham provided the following opinion regarding the appropriate level of evidence of substantiation:

qualified experts in the field of urology, including the prevention and treatment of prostate cancer, and in the field

of clinical testing relating to the prevention and treatment of prostate cancer, would require claims that the POM

Products treat, prevent, or reduce the risk of prostate cancer, or are clinically proven to do so, to be supported by

at least one well-conducted, randomized, double-blind, placebo-controlled clinical trial involving an appropriate

sample population and with an appropriate endpoint. (CX1287 (Eastham Expert Report at 006, 012)).

649. Dr. Eastham testified that even if a product is safe and might create a benefit, like a fruit juice, he would still

require an RCT to justify claims that Respondents are charged with making. (Eastham, Tr. 1325-31).

650. Dr. Eastham testified that studies of disease prevention should involve 10,000 to 30,000 men and that such

studies are “incredibly expensive” and in the range of $600 million. (Eastham, Tr. 1328).

651. Dr. Eastham testified additionally that animal or in vitro studies alone do not provide sufficient scientific

evidence to support a claim that a product prevents or treats prostate cancer, even where the agent being tested

is nontoxic. (Eastham, Tr. 1284-85).

652. Dr. Eastham has performed over 200 radical prostatectomies per year for a number of years before there

were any RCTs showing that they worked. (Eastham Tr. 1331-32; PX0358 (Eastham, Dep. at 154-55)). Dr.

Eastham performed these radical operations without RCTs despite the fact that the side-effects of this operation

are significant and include impotence, incontinence, bleeding, embolisms, and infection, plus risks of general

anesthetic. (Eastham, Tr. 1331-32).

653. Dr. Eastham testified that he has removed hundreds of prostates despite all the above stated risks and without

RCT substantiation, yet he would not consider the use of pomegranate juice to treat, prevent or reduce the risk of

prostate cancer unless supported by RCTs. (Eastham, Tr. 1332).

d. Dr. Arnold Melman

654. Dr. Melman provided the following opinion regarding the appropriate level of evidence of substantiation:

to constitute competent and reliable scientific evidence demonstrating efficacy in preventing, reducing the risk

of, or treating erectile dysfunction, experts in the field of erectile dysfunction would require at least one clinical

trial, involving several investigatory sites, which is well-designed, randomized, placebo-controlled, and doubleblinded. (CX1289 (Melman Expert Report at 0004-05)).
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*80 655. Dr. Melman testified that the only kind of science to support claims that a product helps with erectile

dysfunction are two double-blind placebo based randomized trials, conducted in two separate institutions, with a

group large enough to produce a statistically significant (p < 0.05) result. Dr. Melman testified that you cannot

properly make public claims that a product helps with erectile dysfunction in absence of such trials. (Melman, Tr.

1135, 1138-39; CX1289 (Melman Expert Report at 0008-11)).

656. Dr. Melman also testified that the men's sexual partners must also confirm the result; that for a study to claim

any improvement in participants, the men must have reached orgasm; and that the sexual partner must achieve

sexual satisfaction. (Melman, Tr. 1139-43).

657. Dr. Melman testified that “pomegranate juice is a drug,” and therefore the FDA standard for pharmaceutical

drugs should apply. (PX0360 (Melman, Dep. at 17-19); Melman, Tr. 1141).

658. Dr. Melman conceded that he has never conducted any clinical work on a food product, including

pomegranates. (Melman, Tr. 1164-65).

659. Dr. Melman is developing a gene-transfer therapy for erectile dysfunction called hMaxi-K which is injected

into the penis. (Melman, Tr. 1148, 1192). Dr. Melman announced to the public, in an interview with the New York

Observer, that his hMaxi-K produced spontaneous normal erections in men suffering from erectile dysfunction.

(Melman, Tr. 1154). Dr. Melman acknowledged that people have died or gotten very sick from gene-transfer

therapy. (Melman, Tr. 1158).

660. While Dr. Melman testified that Respondents must have at least one clinical trial, involving several

investigatory sites, which is well-designed, randomized, placebo-controlled, and double-blinded before they can

publicize the positive effects of pomegranate juice on men with erectile dysfunction, Dr. Melman publicized

preliminary results of studies on his gene-transfer therapy based only on the results of an animal study. (Melman,

Tr. 1149-55).

4. Testimony from Respondents' experts on whether RCTs are required

a. Dr. Denis Miller

661. Dr. Miller provided the following opinion regarding the appropriate level of evidence of substantiation:

because pomegranates are a food, an appropriate level of scientific substantiation regarding the health benefit

claims of pomegranates should be flexible, and consider several factors (including the risk of harm) with the

desirability of getting information to the public, the validity of the science, costs of the science, and the nature of

the claim. (PX0206 (Miller Expert Report at 15)).

662. Dr. Miller opined that the standard for substantiating claims for pure foods which are clearly safe need not

be as rigorous as that for a new drug or anticancer agent, but should be based on reliable and competent scientific

data that confirm its safety, and support a relevant and beneficial effect; and that valid, scientifically conducted

basic science could be enough to support a claim, depending on the claim, so long as the product is not claimed

to be a substitute for conventional drug therapies or medical care. (PX0206 (Miller Expert Report at 15); Miller,

Tr. 2194).

*81 663. Dr. Miller opined that if the product is a whole food or a derivative of a whole food and it is obviously

safe, there should be a cost benefit analysis to determine whether it makes sense to report possible, or probable
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benefits of consumption, and to err on the side of giving more information to the public and medical community,

so long as the claim does not suggest (by use of absolutes or in other ways) that an individual forgo conventional

medical care or treatment based on the consumption of the product and/or suggest that the underlying science is

valid. (PX0206 (Miller Expert Report at 7-8)).

664. Dr. Miller opined that retrospective or prospective observational cohort or case-control studies are not

feasible to study the benefits of a food and that a double-blind, placebo controlled trial evaluating POM Products

as prostate cancer protective agents would take decades and thousands of patients and would have to control

for other naturally occurring, dietary antioxidants, anti-inflammatory, and anticancer agents as well as life-style

activities (e.g., exercise, smoking, alcohol use), genetic predisposition, racial and ethnic factors, benign prostatic

hypertrophy, and other factors that might have an effect on carcinogenesis of prostate cancer. (PX0206 (Miller

Expert Report at 0014)).

665. Dr. Miller opined that the claim being made about a product is relevant to the level of substantiation required.

(Miller, Tr. 2195, 2210).

666. Dr. Miller opined that even if a food were marketed for the treatment or prevention of a disease, the level

needed to substantiate claims about a food is more relaxed or less rigorous than it would be for a drug because

with a drug, one would have to consider the safety of the agent, the efficacy of the agent, and the risk-benefit

ratio. (Miller, Tr. 2210-11).

667. Dr. Miller testified that if one were claiming a fruit juice prevents prostate cancer, and there was reliable

scientific data to support that claim, one could make that claim without an RCT. (Miller, Tr. 2201).

668. Dr. Miller testified that you do not need to go through the process of clinical testing and randomized clinical

trials to establish the safety and efficacy of a food when there is already reliable scientific evidence supporting

that. (Miller, Tr. 2205-06).

669. Dr. Miller opined that if a dietary supplement is derived from a pure food it should require the same level

of substantiation as a food. In the alternative, if a dietary supplement is “a mixture of fifty different minerals

and elements and vitamins,” then it is different than a food and would require a different level of substantiation.

(Miller, Tr. 2213).

670. Dr. Miller testified that because a food is not patentable, it is not reasonable to require the maker of a

potentially beneficial foodstuff to conduct a prohibitively expensive RCT to claim that it is beneficial to health.

(PX0206 (Miller Expert Report at 16)).

b. Dr. David Heber

*82 671. Dr. Heber provided the following opinions regarding the appropriate level of evidence of substantiation:

(1) double-blind placebo-controlled trials have limited usefulness for nutritional research; (2) the nutritional

complexity of pomegranate juice and extract makes controlled studies less suitable for researching the health

benefits of pomegranate juice and extract; (3) prospective randomized controlled trials demand that a nutrient act

like a drug and that is an unreasonable requirement for nutritional studies because nutrients occur in a food matrix;

and (4) the prospective randomized trial cannot practically be imposed as a requirement for nutritional science.

(PX0192 (Heber Expert Report at 0013-16)).
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672. Dr. Heber testified that most experts in the field of nutrition consider competent and reliable science to support

health claims for pomegranate juice based upon the totality of evidence, which does not necessarily include RCTs.

(Heber, Tr. 2166, 2182).

673. Dr. Heber testified that in dealing with nutrients, RCTs are often infeasible and too expensive; that the drug

standard should not be applied to nutrients; and that most experts in the field of nutrition believe that RCTs have

some significant drawbacks when it comes to the study of nutrient substances like pomegranates. (Heber, Tr.

1948-50).

c. Dr. Dean Ornish

674. Dr. Ornish provided the following opinion regarding the appropriate level of evidence of substantiation: it

is important to carefully examine the totality of scientific evidence in determining whether or not pomegranate

juice in its various forms is beneficial and that in a nutritional context, in vitro and animal studies may be more

effective in testing the efficacy of a nutrient. (PX0025 (Ornish Expert Report at 0005); Ornish, Tr. 2327-31).

675. Dr. Ornish testified that new drugs, which always have toxicities and side effects, need to be held to a higher

standard than a juice that is derived from a fruit that has been around for thousands of years. (Ornish, Tr. 2324-25,

2340, 2381).

676. Dr. Ornish testified that if a fruit or beverage is held to the standard required of drugs, no one would be

able to meet that standard. No manufacturer would spend billions of dollars to test a fruit unless it is a drug like

Lipitor, where one could make billions of dollars a year and it would be worthwhile to make such an investment.

(Ornish, Tr. 2324-25).

677. Dr. Ornish opined that there is a world of difference between offering juice as a healthy lifestyle choice or as

an adjunct to conventional treatments versus offering it as a replacement for conventional medical care. (PX0025

(Ornish Expert Report at 0008)).

678. Dr. Ornish also opined that “it is an extreme position to state that the therapeutic efficacy of a fruit juice or

extract of pomegranate juice should be held to the same standard of evidence as a new drug.” Dr. Ornish further

opined that the study of pomegranates or pomegranate juice is different than studying a new drug, in which harmful

side-effects, both short-term and long-term, are the rule rather than the exception. (PX0025 (Ornish Expert Report

at 0008)).

*83 679. Dr. Ornish opined that RCTs, even when conducted perfectly, do not control for all sources of bias

and may inject new ones unique to RCTs. For example, in studying a fruit or food, it is hard to do double-blind,

randomized, placebo-controlled trials. Once a participant is assigned to the control group, and they know what

the intervention is, they can consume the food or juice anyway, whereas one would not be able to do so with an

experimental drug. (PX0025 (Ornish Expert Report at 0008); Ornish, Tr. 2328-29, 2356).

680. Dr. Ornish also testified that RCTs have shown that angioplasties and stents do not prevent heart attacks or

prolong life, yet the number of these procedures performed is greater than ever. (PX0025 (Ornish Expert Report

at 0007); Ornish, Tr. 2380-81).

681. Dr. Ornish opined that while there are limitations to extrapolating from in vitro and animal studies to human

studies, it is false to say this research has no value in determining therapeutic efficacy. (PX0025 (Ornish Expert

Report at 0007)).
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d. Dr. Jean deKernion

682. Dr. deKernion provided the following opinion regarding the appropriate level of evidence of substantiation:

if you have a drug with toxicities, it is extremely important to have a test with a placebo group, because it gives

one a valid measure of the toxicity of the drug. But in the case of something like fruit juice, that has low or no

toxicity at all, is it not necessary to use an RCT or placebo-controlled kind of test. (deKernion, Tr. 3060).

e. Dr. Arthur Burnett

683. Dr. Burnett provided the following opinion regarding the appropriate level of evidence of substantiation:

(1) because pomegranate juice is a harmless fruit product that creates no material risk of harm and assuming

that drinking pomegranate juice is not advocated as an alternative to following medical advice, information of

pomegranate juice's likely benefit may be communicated to consumers; and (2) studies such as double blinded,

placebo-based tests are not required before permitting this information to be given to the public. (Burnett, Tr.

2272-74; PX0149 (Burnett Expert Report at 0006-07)).

684. Dr. Burnett testified that the standard of substantiation is different for a product that is directly associated as

a treatment for erectile dysfunction and for a product that claims to have helpful benefits for or improves one's

erectile function. (Burnett, Tr. 2260-62, 2303).

f. Dr. Irwin Goldstein

685. Dr. Goldstein provided the following opinion regarding the appropriate level of evidence of substantiation:

health care practitioners who treat patients concerned with erectile health would not hold pomegranate juice to

the standards of safety and efficacy traditionally required by the FDA for approval of a pharmaceutical (including

performance of large, double-blind, placebo-controlled pivotal clinical trials) before recommending pomegranate

juice to their patients. (PX0189 (Goldstein Expert Report at 0003, 0014)).

*84 686. Dr. Goldstein testified that when studying pomegranate juice and its effect on erectile function, RCT

studies are not necessary because the safety of natural fruit juice is not questionable. Furthermore, Dr. Goldstein

questioned whether one could make a placebo pomegranate juice. By contrast, Dr. Goldstein testified that RCTs

are needed for pharmaceutical drugs, which are unnatural and developed in laboratories, to assess safety and

efficacy. (Goldstein, Tr. 2599-01, 2619).

687. Dr. Goldstein testified that an article he co-authored stated that RCTs are considered the criterion standard

for determining causality, but that that article was written in the context of the pharmaceutical industry and

pharmaceutical drugs like Viagra, Levitra and Cialis that have been studied with randomized clinical trials for

determination of their safety and efficacy. Dr. Goldstein further testified that it would be ideal if there could

be randomized clinical control data for nutraceuticals, but that in reality, that is not going to happen or it is not

possible. (Goldstein, Tr. 2613-14).

5. Determinations on the required level of substantiation

a. Type of claims
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688. The level of scientific evidence required to support a claim depends on the claim being made. (Stampfer,

Tr. 830-31; Miller, Tr. 2195, 2210).

689. Claims of efficacy can be made only when a causal relation with human disease is established. (CX1293

(Stampfer Expert Report at 0030)).

690. A claim that users of a product have a lower incidence of disease is not the same thing as a claim that use of

the product caused them to have a lower incidence of disease. (Stampfer, Tr. 798).

691. A claim that studies indicate that a product lowers the risk of heart disease and diabetes does not imply that

a causal link is established, i.e., that the product caused users to have lower risk of heart disease and diabetes.

(Stampfer, Tr. 817).

692. If the claim does not imply a causal link, for example, if the claim is that there is some evidence to suggest

the possibility that nuts may reduce the risk of diabetes, then evidence short of RCTs can support that claim.

(Stampfer, Tr. 830-31; CX1293 (Stampfer Expert Report at 0029-30)).

693. If the claim does not suggest (by use of absolutes or in other ways) that an individual should forgo

conventional medical care or treatment based on the consumption of a safe product, one can relax the requirement

for an RCT. (Miller, Tr. 2201-02; PX0206 (Miller Expert Report 7-8)).

b. Type of product

694. The level of scientific evidence required to support a claim depends on the product being promoted. (Miller,

Tr. 2196, 2198; PX0206 (Miller Expert Report at 8)).

695. The potential risk of the product must be weighed against the potential benefit and harm of keeping

information from the public. (Sacks, Tr. 1559; PX0361 (Sacks, Dep. at 137)). In recommending a food or drug,

you have to take into account the risk of harm from the product. (Stampfer, Tr. 829).

*85 696. RCTs are needed for pharmaceutical drugs to assess safety and efficacy because pharmaceutical drugs

are unnatural, developed in laboratories, and have toxicities. (Goldstein, Tr. 2600-01, 2620; deKernion, Tr. 3060).

697. Pharmaceutical drugs, which are not known to be safe and always have toxicities and side effects, are held

to a higher standard than a juice that is derived from a fruit that has been around for thousands of years. (Ornish,

Tr. 2324-25, 2340, 2381; PX0025 (Ornish Expert Report at 0008); Goldstein, Tr. 2600-01, 2620; deKernion, Tr.

3060).

698. The standard applied to new drugs should not be applied to nutrients as long as the product is not claimed

to be a substitute for conventional drug therapies or medical care. (PX0206 (Miller Expert Report at 15); Miller,

Tr. 2194; Heber, Tr. 1948-50; PX0025 (Ornish Expert Report at 0008)).

699. Pomegranate juice is a natural fruit product with health promoting characteristics. The safety of pomegranate

juice is not in doubt. (Miller, Tr. 2194, 2201; PX0206 (Miller Expert Report at 10); Heber, Tr. 1948-50; PX0025

(Ornish Expert Report at 0007)).
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c. Feasibility of RCTs

700. RCTs can be beneficial, but they are not perfect and, when dealing with nutrition, they have their own set

of limitations as well. (Ornish, Tr. 2329).

701. In a nutritional context, a hypothesis about disease causation can rarely, if ever, be directly tested in humans

using the RCT design. (Stampfer, Tr. 832-33; PX0362 (Stampfer, Dep. at 73, 98); CX1293 (Stampfer Expert

Report at 0029-30); PX0361 (Sacks, Dep. at 111, 137); PX0192 (Heber Expert Report at 0009-12)).

702. In studying a drug, RCTs are possible because placebos can be used and subjects, therefore, do not know if

they are getting a drug or not. (Ornish, Tr. 2328).

703. In studying a fruit or food, it is difficult to do double-blind, randomized, placebo-controlled trials because

the subjects know what they are consuming. Once a participant is assigned to the control group, and they know

what the intervention is, the participant can consume the food or juice anyway, whereas one would not be able to

do so with an experimental drug. (PX0025 (Ornish Expert Report at 0008); Ornish, Tr. 2328-29, 2356; Goldstein,

Tr. 2600-01, 2620).

704. In a nutritional context, RCTs are extremely expensive and often not feasible because of the costs of

conducting them. (Sacks, Tr. 1559-61; Stampfer, Tr. 810, 813-14; Heber, Tr. 1948-50; PX0192 (Heber Expert

Report at 0013-16); Goldstein, Tr. 2613-14; (Eastham, Tr. 1328) (the standard studies for chemoprevention should

involve 10,000 to 30,000 and are “incredibly expensive,” costing in the range of $600 million)).

705. Because a food, unlike a pharmaceutical drug, is not patentable, it is not reasonable to require the maker of a

potentially beneficial foodstuff to conduct an RCT to claim that it is beneficial to health. (PX0206 (Miller Expert

Report at 16)). No manufacturer would spend billions of dollars to test a fruit unless it is a drug where one could

make billions of dollars a year and was worthwhile to make such an investment. (Ornish, Tr. 2324-25).

d. Conditions where RCTs are necessary

*86 706. RCTs are needed for a nutrient supplement if one makes a claim that the product causes the effect of

treating, preventing, or reducing the risk of a disease and offers the nutrient supplement as a replacement to medical

care to prevent, treat or reduce the risk of disease. (PX0206 (Miller Expert Report at 15); Miller, Tr. 2194; PX0025

(Ornish Expert Report at 0008); see also CX1293 (Stampfer Expert Report at 0029); Stampfer, Tr. 830-31).

707. RCTs are not required to convey information about a food or nutrient supplement where: the safety of

the product is known; the product creates no material risk of harm; and the product is not being advocated as

an alternative to following medical advice. (PX0149 (Burnett Expert Report at 0006-07); deKernion, Tr. 3060;

Goldstein, Tr. 2600-01, 2620; PX0025 (Ornish Expert Report at 0008)).

e. Necessary substantiation

708. If a dietary supplement is derived from a pure food, it should require the same level of substantiation as a

food. By contrast, if a dietary supplement is “a mixture of fifty different minerals and elements and vitamins,”

then it is different than a food and requires a different level of substantiation. (Miller, Tr. 2213).
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709. Because pomegranate juice is a food, the appropriate level of scientific substantiation regarding health benefit

claims of pomegranate juice in its various forms should be flexible, and consider several factors, including the

risk of harm, the validity of the science, costs of the science, and the nature of the claim, including whether it

is offered as a substitute or replacement for a conventional therapy. (Miller, Tr. at 2201; PX0206 (Miller Expert

Report at 11, 15). See also PX0025 (Ornish Expert Report at 0005); Ornish, Tr. 2329-31).

G. Substantiation for Respondents' Heart Disease Claims

1. Substantiation standard for heart disease claims

710. Experts in the field of cardiovascular health would not require RCTs to substantiate health benefit claims for

harmless pure fruit products like pomegranate juice. (Ornish, Tr. 2327-30; see also Miller, Tr. 2194, 2201; but

see Sacks, Tr. 1545-48) (testifying that RCT trials are not necessary to test the benefit of food categories that are

included in a diet that has already been tested, like the DASH diet; that pomegranates are in the fruit category

and, thus, do not need to be tested with RCTs; but that pomegranate juice is different from pomegranates and

thus held to a higher standard).

711. Experts in the field of cardiovascular health would require that a product be scientifically evaluated through

rigorous scientific and clinical studies, which does not necessarily include RCTs, to make claims that the product

can treat, prevent or reduce the risk of heart disease. (Heber, Tr. 1948-49, 2058, 2085, 2166, 2182 (food products

must be evaluated on the totality of the scientific evidence that is competently performed, which includes in vitro

animal studies and human studies, along with basic science about nutritional uptake on metabolism). But see Sacks

CX1291 (Sacks Expert Report at 0010) (requiring “well-designed, well-conducted, randomized, double-blinded,

controlled human clinical studies” with strong “p” values)).

*87 712. To substantiate a claim that a food or a diet supplement can treat heart disease, one needs

appropriately analyzed data showing significant changes in valid surrogate markers of cardiovascular health and

the study subjects must have established cardiovascular disease (“CVD”) or coronary heart disease (“CHD”). To

substantiate a claim that a food or a diet supplement can prevent or reduce the risk of heart disease, the study

subjects may be persons with or without CVD or CHD. (See CX1291 (Sacks Expert Report at 0010-11 (also

stating requirement of RCTs)).

713. The same level of evidence stated in F. 711-712 is needed to show that clinical studies, research, or trials

prove that a product treats heart disease. (See CX1291 (Sacks Expert Report at 0011).

714. There must be a sufficient number and diversity of subjects tested in a study to conclude that the measured

effect of a product on heart disease can be generalized to a larger population. The study also must be of sufficient

duration to show that the effect will last. (CX1291 (Sacks Expert Report at 0014)).

2. Overview of cardiovascular disease

715. A heart attack occurs when there is a sudden rupture of inflamed plaque which covers about 50 percent of

the inner surface (lumen) of a coronary vessel. (Heber, Tr. 1959).

716. Plaque is the end result of decades of damage to the blood vessel, which begins with oxidation. The process

of plaque formation begins when a protein called low-density lipoprotein (“LDL”) or so-called “bad cholesterol,”

which circulates through the blood, becomes oxidized. (Heber, Tr. 1959).
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717. When the LDL cholesterol gets oxidized, the chemical nature of the protein changes, causing the protein

to reside and deposit in the wall of the blood vessel, where it accumulates. (Heber, Tr. 1959; CX1358 (Aviram,

Dep. at 5)).

718. Regular cholesterol passes in and out of the arteries, but the oxidized cholesterol remains there. (Heber, Tr.

1959-60).

719. Macrophages (white blood cells that respond to inflammation by digesting cellular debris) come in and they

eat up this oxidized cholesterol. (Heber, Tr. 1960).

720. Macrophages have ravenous appetites which do not stop, and they continue to accumulate until they become

what are called foam cells, which are full of cholesterol and actually burst into the area, bringing in more cells

and more inflammation. (Heber, Tr. 1960).

721. Oxidation is followed by inflammation, which is followed by damage to the interior of the blood vessel. This

damage is detected as yellow streaks in the coronary arteries. As this process progresses, plaque forms and begins

to fill those lumen. (Heber, Tr. 1960).

722. Plaque can have different characteristics; it can be stable or unstable. Unstable plaque is full of oxidized

cholesterol and macrophages, reft with inflammation. (Heber, Tr. 1960).

723. By blocking inflammation and oxidation, it is possible to stabilize plaque. (Heber, Tr. 1960; PX0192 (Heber

Expert Report at 0033)).

*88 724. Inhibitors of the oxidation process are called antioxidants. (CX1358 (Aviram, Dep. at 5)). Punicalagin,

an ellagitannin, is the most abundant polyphenol that accounts for more than 50% of the antioxidant activity.

(PX0025 (Ornish Expert Report at 0008)).

725. Several studies have indicated that pomegranate juice has antioxidant and anti-atherosclerotic properties

due to the presence of multiple polyphenols such as tannins, flavonols, anthocyanins and ellagic acid. (PX0025

(Ornish Expert Report at 0008)).

726. Antioxidants are well known to enhance the biological actions of nitric oxide (“NO”) by virtue of their

capacity to improve endothelial NO synthase (“eNOS”). (PX0055 at 0002; PX0056).

727. Antioxidants are well known to increase and prolong cellular concentrations of NO by protecting it from

oxidation. Antioxidants accomplish this task by neutralizing free radicals. (PX0055 at 0002; PX0056 at 0002;

PX0057; PX0059 at 0001, 0004; PX0190 at 0006).

728. The negative effects on NO caused by shear stress (the force of friction caused by perturbed blood flow around

atherosclerosis) and on the expression of oxidation-sensitive genes can be mitigated by antioxidants. (PX0055

at 0002; PX0056).

729. Dr. Louis Ignarro demonstrated that POM Juice and POMx were able to attenuate the effects of perturbed

shear stress and atherogenisis. However, POMx was significantly more effective at enhancing the expression of

endothelial nitric oxide synthase (eNOS — an enzyme necessary for cellular NO production), decreasing oxygensensitive gene expression, and reducing lesion size. (PX0056).
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730. Antioxidants enhance the bioavailability of NO. (Heber, Tr. 1816; CX0908 at 0001, 0002; PX0058).

731. NO helps maintain healthy blood vessels, which improves blood flow to almost every organ in the body,

including the heart. (Heber, Tr. 1816, 1969).

3. Respondents' basic science studies

732. Respondents have sponsored many published studies in cellular and animal models evaluating the effects of

pomegranate juice and/or its extracts on cardiovascular function. (PX0007; PX0008; PX0010; PX0015; CX0543;

PX0017; PX0022; PX0055; PX0056, PX0057; PX0058; PX0059; CX0053).

a. Dr. Aviram's in vitro and in vivo studies

733. The earliest heart studies on pomegranate juice were carried out by Dr. Aviram at the Technion Institute in

Israel. (Heber, Tr. 1957).

734. Dr. Aviram is a professor and head of the Lipid Research Laboratory at the Technion Faculty of Medicine,

Rappaport Institute for Research in the Medical Sciences and Rambam Medical Center, in Haifa, Israel. (CX1116

at 0001).

735. Dr. Aviram is considered an internationally renowned researcher, pioneer, and one the leading experts in

the world on cholesterol, lipid oxidation and the protective role of dietary antioxidants related to cardiovascular

disease. (Heber, Tr. 1957-58).

736. Dr. Frank Sacks, Complaint Counsel's expert on cardiovascular health, acknowledges that Dr. Aviram's basic

science is good and that Technion is a good research institution. (Sacks, Tr. 1571).

*89 737. For the last 30 years, Dr. Aviram's major research focus has been on dietary antioxidants and

antioxidants in general, especially their role in cardiovascular disease. (CX1358 (Aviram, Dep. at 5)).

738. Before studying pomegranates, Dr. Aviram examined a number of antioxidants from plants, including

lycopene from tomatoes, green tea, citrus fruits, and red wine. (Heber, Tr. 1958).

739. Dr. Aviram published a red-wine study, which explained partially the “French paradox,” that people in

France, even though they eat fatty foods like people in Finland, they do not get heart attacks in France compared

to Finland. It was shown epidemiologically that it has to do with drinking red wine, because red wine contains

antioxidants from the skin of the grape. (CX1358 (Aviram, Dep. at 5)).

740. Dr. Aviram was approached by POM and asked to do the same type of study that he did for red wine, and

other fruits and vegetables, but now for pomegranates. (CX1358 (Aviram, Dep. at 6)).

741. After a year of studying in 1998 or 1999, Dr. Aviram concluded that pomegranate juice had greater antioxidant

potencies than red wine. (CX1358 (Aviram, Dep. at 6)).

742. High-density lipoprotein cholesterol (“HDL” or so-called “good cholesterol”) contains an antioxidant

enzyme, called “paraoxonase” or “PON1” which acts to protect the body against oxygen radicals. (Heber, Tr.

1961).
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743. Dr. Aviram found that pomegranate juice benefits the activity of paraoxonase or PON1 by increasing its

binding to HDL cholesterol. (Heber, Tr. 1961).

744. Beginning in 2000 and continuing until as recently as 2010, Dr. Aviram's in vitro and in vivo research on

pomegranate juice and/or POMx pills showed reduction in oxidation of LDL cholesterol; lessening the uptake of

oxidized and native LDL cholesterol by macrophage foam cells; diminishing the size of atherosclerotic lesions and

foam cells; inhibition of macrophage cholesterol biosynthesis; decrease in macrophage oxidative stress; protection

against cellular lipid peroxidation; reduction of serum lipids and glucose levels; improvement of PON1; and

lessening of platelet aggregation. (PX0007; PX0008; PX0010; PX0015; CX0543; PX0017; PX0022; CX0053).

745. Dr. Sacks acknowledges that some of Respondents' in vitro studies have shown pomegranate juice's favorable

effects on the mechanisms involved in cardiovascular disease and that in vitro studies, like Dr. Aviram's, can be

competent and reliable evidence of an agent's effect on a particular mechanism. (Sacks, Tr. 1578).

746. Dr. Sacks agrees that Dr. Aviram's in vitro studies showed that pomegranate juice inhibits macrophage uptake

of oxidized LDL, which is one component of atherosclerosis, and a significant reduction in atherosclerotic vessels,

but that changes in macrophage levels are not a reliable surrogate marker of heart health. (Sacks, Tr. 1572, 1579,

1622).

b. In vitro and in vivo studies on nitric oxide

*90 747. Respondents have also sponsored research in the area of nitric oxide and understanding its role in

cardiovascular health. (PX0055; PX0056; PX0057; PX0058; PX0059).

748. Respondents have sponsored in vitro and in vivo research by Dr. deNigris, Dr. Napoli, and, Dr. Ignarro to

conduct basic research on the effects of pomegranate juice on nitric oxide in the human body. (PX0055; PX0056;

PX0057; PX0058; PX0059).

749. Nitric oxide is produced by the cells lining the heart blood vessels and by the cells lining the blood vessels of

many organs around the body. Nitric oxide opens up tiny blood vessels and helps, among other things, preserve

blood flow to the heart. (Heber, Tr. 1966-68).

750. Nitric oxide is beneficial in that it improves blood flow to almost every organ in the body that is dependent

upon blood flow. (Heber, Tr. 1969-70).

751. In their in vitro and in vivo studies, Dr. deNigris, Dr. Napoli, Dr. Ignarro, and others found that pomegranate

juice and/or POMx pills demonstrated: increasing and preserving levels of nitric oxide and decreasing expression

of genes associated with stress and progression of atherosclerosis; reducing LDL oxidation, size of atherosclerotic

plaques, and formation of foam cells; reversing effects of shear stress, which can damage the endothelial cells

or thin layer of cells that line the interior of blood vessels; decreasing cellular production and release of oxygen

radicals in the vascular wall; inhibiting activation of oxidation-sensitive genes; and improving biological activity

of nitric oxide. (PX0055; PX0056; PX0057; PX0058; PX0059).

c. Experts' analysis on Respondents' basic research

752. Complaint Counsel's expert witness, Dr. Sacks, opined the following regarding Respondents' basic research:
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• in vitro studies do not provide reliable scientific evidence of what effects a treatment will have inside the human

body;

• animal studies cannot be generalized to describe what effects a treatment has on human subjects and, thus, do

not provide reliable scientific evidence on whether an agent can treat, prevent or reduce the risk of cardiovascular

disease in humans;

• in vitro and animal studies need to be replicated in humans to show an effect on preventing or treating a disease;

and

• there is value in conducting in vitro and animal studies because it is possible to isolate mechanisms of action

and accomplish toxicity or safety testing.

(CX1291 (Sacks Expert Report at 0015-16); PX0361 (Sacks, Dep. at 91)).

753. Respondents' expert witness, Dr. Ornish, opined the following regarding Respondents' basic research:

• in vitro and animal studies are important in considering the totality of evidence in determining whether or not

pomegranate juice in its various forms is beneficial; and

• in vitro and animal studies have value in determining therapeutic value, but there are limitations to extrapolating

from in vitro and animal studies to humans.

*91 (PX0025 (Ornish Expert Report at 005, 007)).

d. Determinations on Respondents' basic research

754. Respondents' basic and animal science shows that pomegranate juice and/or its extract may be beneficial

toward cardiovascular health by, among other things, reducing the oxidation of LDL cholesterol and its uptake,

diminishing the size and scope of atherosclerotic legions, macrophages, and foam cells, lessening platelet

aggregation, and enhancing the presence of nitric oxide. (PX0007, PX0008, PX0010, PX0015, CX0543, PX0017,

PX0022, CX0053, PX0055, PX0056, PX0057, PX0058, PX0059).

755. The basic research relied upon by Respondents is part of the totality of evidence that must be examined in

evaluating the effects of the POM Products, but in vitro and animal studies need to be replicated in humans to

show an effect on preventing or treating a disease. F. 752-753.

4. Overview of Respondents' clinical trials and surrogate markers in clinical studies on heart disease

756. Respondents have sponsored approximately ten published studies on humans evaluating the effect of

pomegranate juice and/or its extracts on cardiovascular health. (PX0004; PX0005; CX0611; PX0014; PX0020;

PX0021; PX0023; PX0038; PX0127; PX0139). Two of these published human studies, the Davidson CIMT Study

and the Ornish MP Study (discussed below), were designed as RCTs. In addition, Respondents conducted several

unpublished human studies on POM Juice and POMx Pills related to cardiovascular health, also discussed below.
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757. Respondents worked with Dr. Aviram and two other pre-eminent research scientists in the field of

cardiovascular health to evaluate the potential benefits of pomegranate juice and/or its derivatives in humans: Dr.

Dean Ornish and Dr. Michael Davidson. (PX0014; PX0023).

758. The qualifications of Dr. Ornish, who also testified as an expert for Respondents, are set forth in F. 227-230.

759. Dr. Davidson is the Clinical Professor of Medicine and Director of Preventive Cardiology at the University of

Chicago Medical Center, Medical Director of Radiant Research, Chicago, and a practicing physician who typically

treats patients with cholesterol abnormalities, coronary artery disease, or clinical atherosclerosis. Dr. Davidson

has been involved, in some manner, in over 700 clinical studies over the past 25 years. (JX0003 at 0004; CX1134

at 0001; CX1336 (Davidson, Dep. at 218-21)).

760. Dr. Sacks regards Dr. Davidson as one of the foremost clinical researchers in the cardiovascular field with a

superb reputation for top-quality clinical trial research in cardiovascular disease. (Sacks, Tr. 1490).

761. In considering whether a study shows a benefit to cardiovascular disease, it is important to look at what

endpoints have been measured. There are two kinds of endpoints: direct endpoints and surrogate markers. (CX1291

(Sacks Expert Report at 0013)).

762. In the case of heart disease, direct endpoints are heart attack, unstable angina, or the need for coronary artery

bypass or angioplasty. Surrogate markers are measurements that are closely linked to the disease process such

that a change in a surrogate marker can confidently be predictive of a change in the disease. (CX1291 (Sacks

Expert Report at 0013)).

*92 763. Blood pressure and LDL cholesterol are recognized as valid surrogate markers of cardiovascular health

in clinical guidelines and by the FDA. (Ornish, Tr. 2334; Sacks, Tr. 1441; CX1291 (Sacks Expert Report at 0013)).

764. LDL cholesterol is a risk factor for heart disease, but is not actually heart disease. For that reason, Dr. Ornish

testified, LDL cholesterol cannot be a valid surrogate. (Ornish, Tr. 2334). Dr. Heber further explained, when a

person has a biomarker such as high LDL cholesterol which increases his or her risk, it is very distal or far away

from the actual event of a heart attack which may be affected by many other factors, such as inflammation and

oxidation. (Heber, Tr. 1974). There are a number of people who have low cholesterol levels, but get heart disease.

(Ornish, Tr. 2334-35). About 50 percent of the people who die from a heart attack actually have cholesterol in

the normal range. (Heber, Tr. 1974). There are people who have high cholesterol levels who do not have heart

disease, and the same is true with high blood pressure. (Ornish, Tr. 2334-35).

765. While the FDA, for the purposes of drug registration and testing, only accepts a limited number of surrogate

markers, the number of indicators that physicians and scientists use is much greater and indicators can be at many

points along the pathway of heart disease. (Heber, Tr. 1973).

766. Most experts (but not all) also recognize C-reactive protein, HDL cholesterol, and triglycerides as valid

surrogate markers. (Sacks, Tr. 1441; CX1291 (Sacks Expert Report at 0013)).

767. Carotid intima media thickness, or “CIMT,” testing measures the combination of the vessel muscle and

atherosclerosis (arterial plaque). There is a moderate connection between a reduction in the intima-media thickness

and a reduction in atherosclerosis. (CX1291 (Sacks Expert Report at 0013); Sacks, Tr. 1442-43)).
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768. Dr. Sacks acknowledged that the CIMT test is “a worthy test” and is relevant to cardiovascular health, but

noted there is disagreement among experts on the prognostic value of CIMT. (Sacks, Tr. 1589-90; CX1291 (Sacks

Expert Report at 0013)).

769. Dr. Sacks opined that if CIMT measures show consistent improvement, this would be an indicator that a

treatment may be beneficial, but that he would be reluctant to rely on CIMT improvements alone, if these were

the only evidence that an intervention treated heart disease. Dr. Sacks referenced a recent article in a leading

cardiology journal that analyzed CIMT in relation to cardiovascular events and found that among a metaanalysis

of 41 randomized trials, “there was no significant relationship between IMT regression and CHD [coronary heart

disease] ... events ... CBV [cerebrovascular] events ... and for all-cause death.” From this, Dr. Sacks opined, there

is broad consensus that at least two types of imaging studies must be obtained to make inferences on benefit to

cardiovascular disease. (CX1291 (Sacks Expert Report at 0014)).

*93 770. Myocardial perfusion (MP) is a measure of blood flow to the heart. Dr. Sacks opined that change in

MP is not recognized as a surrogate marker of therapeutic effects on CHD. Even where blood flow is shown to

be improved, it will not necessarily result in improved cardiovascular health, such as reductions in heart attack

and stroke. (CX1291 (Sacks Expert Report at 0020-21)).

771. Dr. Ornish opined that when researchers measure myocardial perfusion, researchers are actually measuring

what matters most. How much blood flow the heart receives is really the “bottom line” in coronary heart disease.

(PX0025 (Ornish Expert Report at 0012); Ornish, Tr. 2334-35).

5. Cardiovascular studies sponsored by Respondents

a. Aviram 2000 Study

772. In 2000, in a study titled, “Pomegranate juice consumption reduces oxidative stress, atherogenic

modifications to LDL, and platelet aggregation: studies in humans and in atherosclerotic apolipoprotein Edeficient mice” by Aviram M, Dornfeld L, Rosenblat M, Volkova N, Kaplan M, Coleman R, Hayek T, Presser D,

and Fuhrman B (Am. J. Clin. Nutr. 2000: 71;1062-76), (“Aviram 2000 Study”), Dr. Aviram and his colleagues

examined the effect of pomegranate juice consumption on the atherogensis process (the development of fatty

plaques in the walls of arteries) in humans, animal models, and cells.

773. The Aviram 2000 Study consisted of two human studies: one involving 13 subjects who consumed

pomegranate juice daily for two weeks; and one involving 3 subjects who consumed increasing doses for 10

weeks. The authors concluded that the study “showed the antiatherogenic capabilities of PJ [pomegranate juice]

in 3 related components of atherosclerosis, plasma lipoproteins, arterial macrophages, and blood platelets. The

potent antioxidative capacity of PJ against lipid peroxidation may be the central link for the antiatherogenic effects

of PJ on lipoproteins, macrophages, and platelets.” (PX0004 at 0001-02, 0004-05, 0014).

b. Aviram ACE/BP Study

i. About the Aviram ACE/BP Study

774. In 2001, in a study titled, “Pomegranate juice consumption inhibits serum angiotensin converting enzyme

activity and reduces systolic blood pressure” by Aviram M and Dornfeld L, (Atherosclerosis 158 (2001) 195-198)

(“Aviram ACE/BP Study”), Dr. Aviram and his co-workers conducted a study with ten elderly, hypertensive
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patients who drank 50 ml. of pomegranate concentrate daily, for two weeks. (CX0542 at 0002; CX1358 (Aviram,

Dep. at 21)).

775. The Aviram ACE/BP Study measured angiotensin converting enzyme (“ACE”) activity and blood pressure.

(CX0542 at 0001). ACE is an enzyme that alters the function of angiotensin, which relates to blood pressure for

each patient. (Stampfer, Tr. 742).

776. The Aviram ACE/BP Study was unblinded and had no control group; instead, each patient's “before”

measures were compared to his or her “after” measures. (CX1358 (Aviram, Dep. at 22-24); CX0025 at 0012).

*94 777. According to the Aviram ACE/BP Study, seven of the ten patients experienced a statistically significant

36% reduction in serum ACE activity from their baseline measure. (CX0542 at 0001). The article does not

reveal what happened to the ACE levels of the other three patients or analyze the overall results in all ten

patients. (CX1291 (Sacks Expert Report at 0016-17); CX0542 at 0002-03; see also Stampfer, Tr. 741-42; CX1293

(Stampfer Expert Report at 0017-18)). Dr. Aviram testified that there was “no effect” from pomegranate juice on

the other three patients' ACE levels. (CX1358 (Aviram, Dep. at 23)).

778. The Aviram ACE/BP Study reports that all ten patients experienced a statistically significant 5% reduction in

systolic blood pressure from their baseline blood pressure measure. (CX0542 at 0002-03; CX1291 (Sacks Expert

Report at 0016-17)).

779. The Aviram ACE/BP Study concludes that, “pomegranate juice consumption can offer a wide protection

against cardiovascular disease.” (CX0542 at 0003).

ii. Experts' analysis on the Aviram ACE/BP Study

780. Complaint Counsel's experts criticized the Aviram ACE/BP Study on the following grounds:

• the sample size of ten patients is too small to provide reliable evidence that the observed effects would be

generally applicable to a larger population

• the two-week period of the study was too short to provide reliable evidence that the reported improvement in

ACE activity and blood pressure would be enduring; and

• ACE (one of the study endpoints) is not a recognized surrogate marker of cardiovascular disease.

(CX1291 (Sacks Expert Report at 0017); see also Stampfer, Tr. 748).

781. Complaint Counsel's experts also testified that although blood pressure reduction is a validated surrogate for

heart disease, the Aviram ACE/BP Study does not provide competent and reliable evidence to support a claim of

effectiveness for heart disease because it was not a blinded, placebo-controlled study. According to these experts,

given the lack of a control group, it is not possible to conclude what caused the reported improvements in the

subjects' blood pressure levels; and without a control group, this study was simply an observational study on

patients given pomegranate juice concentrate. (CX1291 (Sacks Expert Report at 0017); Sacks, Tr. at 1452-54; see

also Stampfer, Tr. 748, 771; CX1293 (Stampfer Expert Report at 0019)).
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782. Dr. Ornish's response to Complaint Counsels' experts' criticism (F. 780-781) is that the Aviram ACE/BP

Study should be viewed in the larger context of other studies in this area, as its findings are congruent with, and

supportive of, other research. (PX0025 (Ornish Expert Report at 0009)).

783. Dr. Ornish testified that there is a common misconception that a larger study is a better study, but the opposite

can be argued. When a study has a smaller number of patients, the treatment has to be that much more powerful

and that much more consistent for it to be statistically significant. (Ornish, Tr. 2362-63; CX1339 (Ornish, Dep.

at 22-23)).

*95 784. Dr. Aviram explains that comparing the statistics from each patient after treatment to his or her own

statistics before treatment is a valid method to conduct a study. (CX1348 (Aviram, Dep. at 12-13)).

785. A study with a small number of subjects or conducted without a placebo does not weaken the importance

of the result, especially if the results are in agreement with previously published findings conducted through in

vitro, mechanistic, and animal models. (CX1348 (Aviram, Dep. at 18)).

iii. Determination on the Aviram ACE/BP Study

786. The Aviram ACE/BP Study does not provide competent and reliable scientific evidence to support claims

that the POM Products treat, prevent or reduce the risk of heart disease. (See F. 774-785).

c. Aviram CIMT/BP Study

i. About the Aviram CIMT/BP Study

787. The carotid arteries are located on each side of the neck and provide the main blood supply to the brain.

Carotid artery stenosis (“CAS”) is a narrowing or constriction of the inner surface (lumen) of the carotid artery,

usually caused by atherosclerosis. (JX0003 at 0001).

788. Stenosis occurs when a person has more than a 50 percent blockage in one of the carotid arteries. To remove

a blockage in the carotid artery, a person undergoes an operation called an endarterectomy, where the buildup is

removed and a graft is placed in the artery. CAS is a risk factor for heart disease. (Heber, Tr. 1963).

789. In 2004, Dr. Aviram and his co-workers investigated, among other things, the effects of pomegranate juice

consumption by patients with CAS in a study titled, “Pomegranate juice consumption for 3 years by patients with

carotid artery stenosis reduces common carotid intima-media thickness, blood pressure and LDL oxidation” by

Aviram M, Rosenblat M, Gaitini D, Nitecki S, Hoffman A, Dornfeld L, Volkova N, Presser D, Attias J, Liker H,

and Hayek T, (Clin Nutr. 2004; 23:423-33), (“Aviram CIMT/BP Study”). (CX0611).

790. In the Aviram CIMT/BP Study, a group of ten patients with severe CAS consumed 50 ml. of concentrated

pomegranate juice daily for one year and five of them continued for up to three years. A second group of nine

patients who did not consume pomegranate juice acted as a control. (CX0611 at 0001-02).

791. In the Aviram CIMT/BP Study, in the control group that did not consume pomegranate juice, the patients'

carotid intima-media thickness increased by 9% during one year, whereas, pomegranate juice consumption

resulted in a significant CIMT reduction, by up to 30%, after one year. (CX0611).
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792. In the Aviram CIMT/BP Study, in two out of the ten patients on pomegranate juice (after 3 and 12 months)

due to clinical deterioration, carotid endartherectomy surgery was performed. Their carotid lesions were analyzed

and compared to lesions obtained from seven patients that did not consume pomegranate juice (not the patients of

the placebo group). The cholesterol content in carotid lesions from the two patients that consumed pomegranate

juice was lower by 58% and 20%, respectively, in comparison to lesions obtained from CAS patients that did not

consume pomegranate juice. The lipid peroxides content in lesions obtained from the patients after pomegranate

juice consumption for 3 or 12 months was significantly reduced by 61% or 44%, respectively, as compared to

lesions from patients that did not consume pomegranate juice. (PX0025 (Ornish Expert Report at 0011)).

*96 793. Dr. Ornish testified that the findings in the Aviram CIMT/BP Study suggest that oxidative stress,

including oxidation of LDL to a form that makes it more likely to cause arterial blockages and cause foam cell

production in macrophages (macrophage-derived foam cells play integral roles in all stages of atherosclerosis)

may have been reduced by pomegranate juice consumption in these patients. (PX0025 (Ornish Expert Report at

0011)).

794. The Aviram CIMT/BP Study reports that the pomegranate juice group members' systolic blood pressure

was significantly (p < 0.05) reduced by 12% after one year of pomegranate juice consumption compared to their

baseline values. In the group that did not consume pomegranate juice, blood pressure was unchanged. (CX0611

at 0005).

795. The CIMT and blood pressure changes described in the Aviram CIMT/BP Study are within-group analyses.

The Study did not provide any between-group statistical analysis, that is, analysis of changes in CIMT and blood

pressure between the active and control groups at the end of the study. (Sacks, Tr. 1456-57; CX0163 at 0017

(stating that between group analysis was not performed for any of the outcomes)). Dr. Aviram explained that each

subject in the study served as his or her own control. (CX1358 (Aviram, Dep. at 27-28, 32)).

796. The Aviram CIMT/BP Study concluded: “pomegranate juice consumption (by patients with carotid artery

stenosis) possess anti-atherosclerotic properties, as it substantially decreased serum oxidative stress and, in

parallel, reduced common carotid intima-media thickness.” (CX0611 at 0009).

797. The Aviram CIMT/BP Study also concluded that the “results of the present study thus suggest that PJ

[pomegranate juice] consumption by patients with CAS decreases carotid IMT and systolic blood pressure and

these effects could be related to the potent antioxidant characteristics of PJ polyphenols.” (CX0611 at 0002).

ii. Experts' analysis on the Aviram CIMT/BP Study

798. Dr. Sacks testified that a qualified scientist would not be able to conclude with any credibility that the

Aviram CIMT/BP Study's reported improvements in the treatment group were caused by their consumption of

pomegranate juice and not some other factor because of: the lack of a randomized, placebo-controlled group; the

fact that the patients in the active and control groups received different treatment; the small sample size, and the

lack of any between-group statistical analysis. (Sacks, Tr. at 1459, 1585; CX1291 (Sacks Expert Report at 0019)).

799. Dr. Sacks concedes that he has no basis to disagree with Dr. Aviram's numbers. (Sacks, Tr. 1589-90).

800. Dr. Stampfer concluded the Aviram CIMT/BP Study does not support Respondents' heart disease prevention

and treatment claims or their lower blood pressure claims. (CX1293 (Stampfer Expert Report at 0018)).
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801. Dr. Ornish responds to Complaint Counsels' experts' criticism (F. 798-800) that the Aviram CIMT/BP Study

should be viewed in the larger context of other studies in this area, as its findings are congruent with and supportive

of other research. (PX0025 (Ornish Expert Report at 0010-11)).

*97 802. Dr. Ornish agreed that the Aviram CIMT/BP Study was limited in scope and opined: “Thus, while not

at all conclusive, the study suggests a benefit.” He further testified that the Aviram CIMT/BP Study (2004) was

“very provocative and interesting and laid the groundwork for even more conclusive studies.” (PX0025 (Ornish

Expert Report at 0010-11); PX0355 (Ornish, Dep. at 107)).

803. Dr. Heber also testified that small studies can be more informative than large studies. (Heber, Tr. 1963).

iii. Determination on the Aviram CIMT/BP Study

804. The Aviram CIMT/BP Study does not provide competent and reliable scientific evidence to support claims

that the POM Products treat, prevent or reduce the risk of heart disease. (See F. 789-803).

d. Ornish MP Study

805. Dr. Dean Ornish and the Preventative Medicine Research Institute (“PMRI”) conducted two studies for

Respondents: (1) Sumner M, et al., Effects of Pomegranate Juice Consumption on Myocardial Perfusion in

Patients with Coronary Heart Disease, 96 Am. J. Cardiology 810 (2005) (“Ornish MP Study”) (CX1198; see

JX0003 ¶ B.16); and (2) the Ornish CIMT Study (unpublished, 2005). (CX0754; see JX0003 ¶ B.16).

806. These studies (F. 805) were the only studies ever conducted by Dr. Ornish to consider whether a single food

product has health benefits. (Ornish, Tr. 2464).

807. The contract setting forth the terms of the two studies conducted by Dr. Ornish (F. 805) was a September

19, 2003, letter agreement between the Resnicks, as Trustees of the Stewart and Linda Resnick Revocable Trust,

and Dr. Ornish's organization, PMRI. (CX0613 at 0001). Attached to the letter agreement were protocols for the

two studies. Although the Ornish MP Study budget was $708,436, and the CIMT Study budget was $496,390, the

funding of these studies was cut short. (Ornish, Tr. 2431-35, 2436, 2441, 2454).

i. About the Ornish MP Study

808. In the Ornish MP Study, Dr. Ornish and his colleagues investigated whether the daily consumption of

pomegranate juice for three months would affect myocardial perfusion (or blood flow) in 45 patients who had

coronary heart disease and myocardial ischemia (narrowing of the arteries) in a randomized, placebo-controlled,

double-blind study. (PX0023 at 0001; Ornish, Tr. 2336).

809. In the Ornish MP Study, patients were randomly assigned into one or two groups: a pomegranate juice group

(240 ml./day, approximately 8 ounces) or a placebo group that drank a beverage of similar caloric content, amount,

flavor, and color. (PX0023 at 0001-02).

810. The Ornish MP Study provides data on three imaging measures at baseline and three months for myocardial

perfusion: the summed rest score, or “SRS” (imaging results before the pharmacologic or exercise challenge), the

summed stress score, or “SSS” (imaging results after the pharmacologic or exercise challenge) and the summed
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difference score, “SDS” (calculated by subtracting the SRS from the SSS). (CX1198 at 0003 (Table 2); CX1291

(Sacks Expert Report at 0020)).

*98 811. The Ornish MP Study indicated that after three months there was a significant (p = 0.05) improvement

of 17% in the SDS score in the POM Juice group, as compared to an average worsening of 18% in the control

group. The comparative benefit of the pomegranate juice group to the placebo group in the Ornish MP Study was

about 35 percent. (PX0023 at 0001; Ornish, Tr. 2337-38; Heber, Tr. 1972).

812. Those differences (F. 811) were statistically significant and the results were published in the American

Journal of Cardiology. (PX0023; Ornish, Tr. 2337-39; Heber, Tr. 1971-72).

813. The Ornish MP Study also indicated that there were no statistically significant differences between the two

groups in SSS and SRS, and no significant changes in blood pressure, cholesterol, LDL, HDL, or triglycerides.

(CX1198 at 0003-04, Table 3 (notation below table); CX1291 (Sacks Expert Report at 0024)).

814. A conclusion of the Ornish MP Study was that “[t]he results of this study demonstrate, for the first time, that

daily consumption of pomegranate juice for 3 months may decrease myocardial ischemia and improve myocardial

perfusion in patients who have ischemic CHD [coronary heart disease] as measured by the SOS.” (PX0023 at

0004).

815. Another conclusion of the Ornish MP Study was that “[a]lthough the sample in this study was relatively small,

the strength of the design and the clinically significant and statistically significant improvements in myocardial

perfusion observed in the experimental group over a rather short period suggest that daily consumption of

pomegranate juice may have important clinical benefits in this population. (PX0023 at 0004).

816. The American Heart Association (“AHA”) rejected the Ornish MP Study abstract in August 2004. Dr.

Ornish asked the AHA's chairman of scientific sessions to reconsider, but the chairman responded that “[m]ultiple

qualified, blinded graders scored this abstract below acceptable range.” (CX0672, CX0680).

817. In November 2004, the Journal of the American Medical Association (“JAMA”) rejected the Ornish MP

Study manuscript. In response to Dr. Ornish's request for feedback, the Deputy Editor of JAMA responded that

“the study appears very preliminary, with small sample size, apparent baseline imbalances between groups, use

of an intermediate endpoint as main outcome measure, and modest differences with large variability.” (CX0699

at 0001-02).

818. Dr. Ornish then submitted the Ornish MP Study manuscript to the American Journal of Cardiology. The

editor accepted it without external peer-reviews. (CX1339 (Ornish, Dep. at 200); CX0715).

ii. Experts' analysis on the Ornish MP Study

819. In trial testimony and in his expert report, Dr. Ornish acknowledged that “some problems” occurred during

the Ornish MP Study that were not “optimal.” (Ornish, Tr. 2394; PX0025 (Ornish Expert Report at 0016)).

820. In the Ornish MP Study, although 41 patients completed the study, the published report provided data on

only 39 patients. Complaint Counsel's experts opined that alterations in the original sample size may be critical

when there is a borderline “p” value. (CX1291 (Sacks Expert Report at 0022); Sacks Tr. 1478-79; Ornish, Tr.

2394; see CX1198 at 0003 (Table 2); CX0664 at 0001).
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*99 821. Dr. Ornish agrees that a mistake was made in the Ornish MP Study in not reporting data on 41 patients,

but opined that when data on all 41 patients was analyzed, the difference in SDS remained statistically significant

and, therefore, the conclusions of the study remain valid. If anything, according to Dr. Ornish, the results were

more statistically significant and even stronger because the sample size was slightly larger. (PX0025 (Ornish

Expert Report at 0015); Ornish, Tr. 2347-48; 2394).

822. Dr. Sacks criticized the Ornish MP Study because two subjects in the placebo group did not receive a placebo

treatment. They were tested at baseline and three months, with no intervention, and their data was included in the

final study results. (Sacks, Tr. 1475-77; CX1339 (Ornish, Dep. at 168-70); CX0580 (patients' names in camera)).

823. Dr. Ornish explained that, initially, the two patients had been randomized to the control group in the Ornish

MP Study and their measurements taken at baseline. As a result of funding issues, however, the study was put

on hold. Three months later, the myocardial perfusion study resumed. Because these patients were already in the

control group and their measurements taken at baseline, the decision was made to include them in the control

group. Dr. Ornish explained his rationale for doing so as follows: “effectively, having nothing is the same as

having a placebo beverage. I think it is probably worth putting in context that in any study there are things that

are not optimal because you are dealing with human beings and all the vagaries of that and particularly in a study

where the funding was changed midstream .... But the question is whether those things are considered likely to

have impacted the validity of the study, including in this case the answer is no.” (CX1339 (Ornish, Dep. at 169-71);

PX0025 (Ornish Expert Report at 0016)).

824. Complaint Counsel's experts criticize the Ornish MP Study on the additional ground that that six patients were

unblinded before their three-month test dates — meaning the study patients discovered which beverage they were

consuming. Dr. Ornish testified that the unblinding of the patients did not undermine the validity of the study or its

conclusions. Dr. Ornish further testified that the expectation that an intervention is beneficial has the potential for

confounding the outcome of a study, but such an outcome was unlikely to have occurred in this study because at

the time that the study was conducted, there was not an awareness in the general population that pomegranate juice

was beneficial or even that the subjects were drinking pomegranate juice (the study was titled a “beverage study”).

(Ornish, Tr. 2345-46, 2403-09; (CX1339 (Ornish, Dep. at 146-49); PX0025 (Ornish Expert Report at 0016)).

825. Drs. Sacks and Stampfer testified that the Ornish MP Study did not use a recognized surrogate marker of heart

disease. (CX1291 (Sacks Expert Report at 0020-21); Sacks, Tr. 1464 (myocardial perfusion, a measure of blood

flow, is not used as the primary outcome in studies of treatment efficacy for coronary heart disease); Stampfer, Tr.

771-72 (blood flow is a research tool but not a recognized surrogate marker)). Even where blood flow is shown to

have been improved, it will not necessarily result in improved cardiovascular health, such as reductions in heart

attack and stroke. (CX1291 (Sacks Expert Report at 0020-21)).

*100 826. Dr. Sacks also testified that proper blood flow from the coronary artery and to the heart is fundamental

to lowering the risk of cardiovascular disease. (Sacks, Tr. 1593).

827. Dr. Ornish opined that blood flow is essential to life, an important measure of heart disease, and the “bottom

line” in coronary heart disease (along with how well the heart is pumping blood) and, thus, when researchers

measure myocardial perfusion, researchers are actually measuring what matters most. (PX0025 (Ornish Expert

Report at 0012); Ornish, Tr. 2331-35).

828. Dr. Ornish further explained: Blood carries oxygen and nutrients that feed the heart. If the blood flow the

heart (perfusion) is reduced, then the heart is no longer receiving enough blood flow to maintain itself. Coronary

heart disease, which is the most common form of heart disease, occurs when the heart does not get enough blood

to fuel itself and blood carries oxygen, which is the fuel for the heart. If the reduction in blood flow is temporary,
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then the person often experiences angina, or chest pain. If this reduction in blood to the heart lasts more than a few

hours, then that portion of the heart that is underperfused may die and turn in to scar tissue — this is commonly

referred to as a “heart attack.” (PX0025-0012; Ornish, Tr. 2331-35).

829. Respondents' experts testified that in comparing myocardial perfusion and LDL cholesterol, myocardial

perfusion is more closely connected as a surrogate marker for cardiovascular disease. When a person has a

biomarker like high LDL cholesterol which increases his or her risk, that is far away from the actual event of a heart

attack, which may be affected by many other factors, such as inflammation and oxidation. There are a number of

people who have low cholesterol levels, but get heart disease. About 50 percent of the people who die from a heart

attack actually have cholesterol in the normal range. There are people who have high cholesterol levels who do

not have heart disease, and the same is true for blood pressure. When measuring myocardial perfusion, researchers

are actually measuring what matters most, which is how much blood flow the heart is receiving. (Ornish, Tr.

2334-35; Heber, Tr. 1974).

830. Dr. Ornish also opined that the degree of blockage is only one of several mechanisms that affect perfusion,

or blood flow to the heart. Other mechanisms include changes in vasomotor tone (how dilated or constricted

the coronary arteries are), platelet aggregation (how sticky the platelets are that can form blood clots that may

partially or completely occlude the flow of blood to the heart), and collateral blood flow (the heart can grow new

blood vessels that provide additional blood flow around partial or even completely blocked arteries if the blockage

occurs slowly overtime). (PX0025 (Ornish Expert Report at 0012)).

831. Dr. Sacks testified that another problem with the Ornish MP Study was that the primary endpoint

measurement indicated in the published study as the main proof of benefit (SDS) was not identified as the primary

endpoint in the protocol. The protocol for the Ornish MP Study provided for measurement of perfusion, but did not

identify whether the primary endpoint would be SSS, SRS, SDS or some other imaging measurement. (CX1291

(Sacks Expert Report at 0021); see also CX0613 at 0009-10). Dr. Ornish conceded that he did not specify that

changes in SDS would be the primary endpoint measure. (PX0025 (Ornish Expert Report at 0014); see also Sacks,

Tr. 1475).

*101 832. Dr. Ornish explained in response to Dr. Sacks' criticism (F. 831) that although the Ornish MP Study

did not specify that changes in SDS would be the primary endpoint measure, it was not necessary to do so since

SDS is a measure of how much of the heart was not receiving enough blood flow. Because SDS is derived by

subtracting SRS from SSS, it is a way of factoring out the amount of infarcted or hibernating myocardium, so Dr.

Ornish could focus on what he was most interested in: SDS. PX0025 (Ornish Expert Report at 0014)).

833. The 35 percent improvement in myocardial perfusion indicated in the Ornish MP Study pertained only to

the SDS scores, and not to the SRS and SSS data. (Sacks, Tr. 1622-24). Dr. Sacks and Dr. Stampfer both stated

that the .05 “p” value of the reported SDS improvement is not very persuasive where, as here, there were three

possible outcome measures (SSS, SRS, and SDS) and only one just met significance. (CX1198 at 0003; Sacks, Tr.

1467 (“when there are ... multiple outcomes ... then a p-value of .05 ... doesn't convey the same level of confidence

than in a situation where there is one primary outcome”); CX1291 (Sacks Expert Report at 0021-22); Stampfer,

Tr. 751 (“[T]he second reason I don't put a lot of weight on this is that the results were only slightly significant

just for one of the three endpoints that was not specified as the primary outcome in advance.”)).

834. Dr. Ornish testified that while the Ornish MP Study did indicate a statistically significant change in the

SDS, Dr. Ornish did not ignore the SSS and SRS measures that were shown in Table 2 of the study. The Ornish

MP Study examined all three measurements in an effort to divine the SDS, as the primary hypothesis was that

pomegranate juice would result in an improvement in SDS, a measure of the heart not receiving enough blood.

(PX0023 at 0003; PX0025 (Ornish Expert Report at 0001); PX0355 (Ornish, Dep. at 128-29; 139)).
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835. Complaint Counsel's experts also criticized the Ornish MP Study based on the large discrepancy in the blood

flow values between the placebo and active groups at baseline. The baseline SSS for the placebo group was 9.6

± 6.5, and the baseline SSS of the juice group was 6.4 ± 3.5, meaning that the placebo group was sicker than the

juice group when the study started. (CX1198 at 0003 (Table 2); CX1291 (Sacks Expert Report at 0022-23); Sacks,

Tr. 1469-72, 77; Stampfer, Tr. 750-52). Study documents from Dr. Ornish's clinic files show that the difference

between the baseline SSS values of the placebo and juice groups was so large as to be statistically significant.

(CX0701 at 0001 (email from M. Sumner to M. Eller, forwarded to D. Ornish, stating, “[t]here was a baseline

difference in SSS between the experimental and the control groups (p <. 04). We don't have to mention this, but

we should keep this in mind.”)).

836. Complaint Counsel's experts further opined that the imbalance in baseline values in the Ornish MP Study

shows that randomization did not produce an active group and a placebo group that were similar on relevant

characteristics. (Stampfer, Tr. 751-52; CX1293 (Stampfer Expert Report at 0019); CX1291 (Sacks Expert Report

at 0023)). It could be predicted that the control group, having worse coronary perfusion than the POM Juice group

at baseline, would have a more accelerated form of the disease and show worsening on follow-up. (CX1291 (Sacks

Expert Report at 0022-23); Sacks, Tr.1469-72, 77; see also Stampfer, Tr. 751 (“[H]ere, the placebo group was

worse off at the start, and it's easy to imagine that if you're worse off at the start, you are going to get worse faster

over time. So, the evidence isn't persuasive.”)). Dr. Sacks stated that the baseline difference should have been

reported in the publication. (Sacks, Tr. 1477; CX1291 (Sacks Expert Report at 0023)).

*102 837. Dr. Ornish testified that although there was a difference in SSS at baseline, the Ornish MP Study

employed an “analysis of variance,” which took into account any baseline differences. The Ornish MP Study

stated: “To test for the effects of experimental condition and time (and their interaction) on medical characteristics,

2 (experimental vs. placebo) X 2 (baseline vs. 3 months) analyses of variance for repeated measurements were

run,” which built into the analysis controlling for baseline differences. Further, when researchers recruit randomly

and look at a number of different measures, it is not uncommon that one difference may be statistically significant

in the group. Even if there had been a difference in SSS at baseline, this would not have undermined the validity

of the study, particularly since it was not Dr. Ornish's primary endpoint measure. (Ornish, Tr. 2343-44, 2394;

PX0025 (Ornish Expert Report at 0015)).

838. Dr. Sacks criticized the Ornish MP Study on the additional basis that blood pressure, cholesterol,

inflammatory biomarkers, and oxidative stress were not improved. (CX1291 (Sacks Expert Report at 0024)).

839. Dr. Ornish himself concluded that “blood pressure ... did not improve” in the Ornish MP Study. (PX0025

(Ornish Expert Report at 17)).

840. Dr. Ornish also explained, the fact that other factors such as blood pressure and cholesterol did not improve

in the Ornish MP Study does not in any way provide evidence that pomegranate juice was not beneficial, as its

effects may have been mediated via other pathways. (PX0025 (Ornish Expert Report at 0017-18)).

841. Dr. Heber testified that in the Ornish MP Study, even though there was no change in blood pressure, one

could not conclude that there was no effect of pomegranate juice on blood pressure, because the primary endpoint

was blood flow, not blood pressure. (Heber, Tr. 2101-02).

842. In any clinical study, it is routine to take a blood pressure, pulse, body temperature, among others, to make

sure patients are healthy. Although blood pressure is measured in many studies, a specific claim on blood pressure

requires a very specific study involving special equipment and personnel. (Heber, Tr. 2101, 2040).
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843. Dr. Sacks notes that Dr. Ornish's study originally was designed to last for 12 months, with measurements

at baseline, three months, and 12 months, but was halted after three months. Dr. Sacks opined that the study

was terminated under unusual circumstances because, according to correspondence, at the time, the p-value was

considered significant rather than at the time the trial was originally set to end. Dr. Sacks further opined that the

shortened study period and failure to report the planned duration is inconsistent with widely-accepted standards

for conduct of clinical trials and undermines any confidence in the findings. (CX1291 (Sacks Expert Report at

0023-24); Sacks, Tr. 1474-75).

*103 844. Dr. Ornish testified that the Ornish MP Study was terminated after three months only because the

Resnicks did not provide the funding that they had previously committed to this study, not because the p-value was

statistically significant at three months. Dr. Ornish further opined that while he did not have 12 months of followup data, this does not undermine the confidence in the three-month findings of the Ornish MP Study. (PX0025

(Ornish Expert Report at 0017)).

845. Complaint Counsel's experts concluded: The interpretation of the Ornish MP Study that is most consistent

with principles of clinical study design and conduct is that the pomegranate juice treatment had no effect on any

measure of cardiac health. (CX1291 (Sacks Expert Report at 0024)). Experts in the field of cardiovascular disease

would not consider the Ornish MP Study to support the proposition that pomegranate juice provides a heart disease

benefit, either in terms of prevention or treatment. (Sacks, Tr. 1472, 1526-28). In light of the problems in the

design and conduct of the study, and the discrepant results of the SSS, SDS, and SRS measures, the study does

not even support the conclusion that pomegranate juice had a favorable effect on coronary perfusion (blood flow

to the heart). CX1291 (Sacks Expert Report at 0024); CX1293 (Stampfer Expert Report at 0018-19)).

846. Respondents' experts concluded the following about the Ornish MP Study:

• Myocardial perfusion (or blood flow to the heart) is a good predictor or surrogate for cardiac events and a better

scientific test than coronary angiography. (PX0025 (Ornish Expert Report at 0012); Ornish, Tr. 2331-34; Heber,

Tr. 1973-74).

• SDS is considered a valid surrogate for coronary heart disease and the Ornish MP Study showed SDS, but

not SRS or SSS, because SDS measures the primary endpoint, how much blood flow the heart is getting when

compared to rest and stress. (Ornish, Tr. 2341-42).

• Differences at baseline for SRS and SSS did not affect the outcome of the Ornish MP Study. (Ornish, Tr. 2343-44,

2394; PX0025 (Ornish Expert Report at 0015).

• Omissions of patient data did not alter the results of the Ornish MP Study. (PX0025 (Ornish Expert Report at

0015); Ornish, Tr. 2347-48; 2394).

• The unblinding of patients or lack of a placebo does not diminish the validity of the Ornish MP Study. (Ornish,

Tr. 2345-46; PX0025 (Ornish Expert Report at 0016); CX1339 (Ornish, Dep. at 148-49)).

• The results of the Ornish MP Study are valid even though they were tested over only a three-month period.

(PX0025 (Ornish Expert Report at 0017).

847. Dr. Ornish concluded that the Ornish MP Study constitutes credible and reliable science showing that

pomegranate juice lessens the risk of cardiovascular problems, that in people who have already had heart disease,

it improves the blood flow and reverses the progression of heart disease; and if you can begin to reverse a disease,
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it would only make sense that pomegranate juice would work even better to help prevent heart disease in the first

place. (Ornish, Tr. 2354-55).

iii. Determination on the Ornish MP Study

*104 848. The Ornish MP Study does not provide competent and reliable scientific evidence to support claims

that the POM Products treat, prevent or reduce the risk of heart disease. (See F. 808-846).

e. Ornish CIMT Study

i. About the Ornish CIMT Study

849. The second study Dr. Ornish conducted for Respondents, the Ornish CIMT Study, was completed in 2005

and is unpublished. (JX0003 ¶ B.16).

850. The Ornish CIMT Study was a randomized, double-blind, placebo-controlled 73-person study that measured

CIMT, blood pressure, and other related mechanisms for 12 months. The primary endpoint of the Ornish CIMT

Study was to investigate the effects of pomegranate juice on CIMT and indices of arterial stiffness for the common

carotid arteries (CCA) in patients with at least one cardiovascular risk factor. The treatment group drank one cup

(eight ounces) of pomegranate juice concentrate daily, and the control group drank one cup of placebo beverage,

daily, for one year. (CX0754 at 0002; CX0613 at 0020).

851. The Ornish CIMT Study was designed to include 200 patients, not 73 patients. Dr. Ornish estimated that

he would need at least 200 patients to show a statistically significant difference in CIMT however, because

recruitment took longer than anticipated (since most patients with heart disease ended up having angioplasty,

stents, and/or bypass surgery at a much higher rate than anticipated), the funding was cut, so Dr. Ornish was only

able to recruit 73 patients, from which 56 patients' pre and post data was collected. (Ornish, Tr. 2352; PX0355a007

at 0002).

852. The primary purpose of the Ornish CIMT Study was to determine if pomegranate juice will affect the

progression of early/subclinical carotid atherosclerosis. (PX355a0006 at 0004; PX0355a007 at 0010).

853. On or about October 21, 2004, PMRI finished its data collection. (CX0697). Commenting on the study data,

Dr. Sumner of PMRI stated, “very few significant interactions ... a mixed, but relatively disappointing bag so

far.” (CX0717 at 0001; CX1344 (Sumner, Dep. at 151-52)).

854. On March 24, 2005, Dr. Sumner stated, “I am looking into additional ways to analyze the data” and

suggested sending “the IMT results to [another researcher] to check before [sending] them to Harley [Liker]/the

Resnicks.” (CX0717 at 0001; see also CX0718 at 0001). The next day, another PMRI employee suggested having

a biostatistician analyze the data “before concluding the juice had a null effect.” (CX0719 at 0001).

855. Dr. Ornish testified that it would be wrong to classify the Ornish CIMT Study as a “null” study. Instead,

Dr. Ornish explained that the study was underpowered because PMRI knew from the beginning that they needed

200 patients. Thus, the study ended with an indeterminate finding, not a clearly nonsignificant finding. (Ornish,

Tr. 2456-61).
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856. The final analysis for the Ornish CIMT Study results was conducted in approximately June 2005 and the

results of the study were provided to Dr. Ornish. (CX1344 (Sumner, Dep. at 168-69); CX0752).

*105 857. In the Ornish CIMT Study, Dr. Ornish observed an improvement in the carotid artery significant to

the 0.13 level as opposed to the 0.15 level. Dr. Ornish testified that if that degree of change had occurred in the

larger number of patients he had projected (i.e., 200 instead of 73), it would have been at the 0.05 level or less

and, thus, would have reached statistical significance. (Ornish, Tr. 2352-54).

858. According to the Ornish CIMT Study unpublished final report, there were no significant changes in the

treatment group relative to the placebo for CIMT thickness or elastic properties. (CX0754 (transmitting “Bev 2

Summary 6-16-05.doc”)).

859. In the Ornish CIMT Study unpublished final report, there also were no significant differences in the treatment

group relative to the placebo group over time for any of the other heart-related measurements, including systolic

and diastolic blood pressure, cholesterol, LDL, HDL, or triglycerides. (CX0754 at 0003, 0005; CX1291 (Sacks

Expert Report at 0024-25); Stampfer, Tr. 754-55; CX1293 (Stampfer Expert Report at 0019-20)).

ii. Experts' analysis of the Ornish CIMT Study

860. Complaint Counsel's expert opined that the Ornish CIMT Study appears to have been well-designed and

well-conducted. (Sacks, Tr. 1485-88, 1603; CX1291 (Sacks Expert Report at 0026)).

861. Dr. Sacks described the results of this study as “convincingly null, showing that pomegranate juice treatment

did not improve CIMT or the other tested parameters” including elasticity of the arteries, blood pressure, or

cholesterol. (Sacks, Tr. 1484-86; CX1291 (Sacks Expert Report at 0026); see also CX1293 (Stampfer Expert

Report at 0019-20); Stampfer, Tr. 755).

862. Dr. Sacks opined that the null results of the Ornish CIMT Study confirm that the purportedly positive results

of Dr. Aviram's unrandomized, uncontrolled 19-patient CIMT/BP Study lack credibility. (Sacks, Tr. 1486-88;

CX1291 (Sacks Expert Report at 0026)).

863. Dr. Ornish opined that it would be more accurate to see the Ornish CIMT Study as a validation of the studies

by Dr. Aviram and Dr. Davidson, since the differences in CIMT would have been statistically significant if the

findings measured in 73 patients were found in the 200 patients that Dr. Ornish originally planned to enroll.

(PX0025 (Ornish Expert Report at 0019)).

864. Dr. Ornish testified that the Ornish CIMT Study was an indeterminate study that cannot be relied upon: “It

neither proves or disproves. It would be, again, as wrong to say that it proves as it would be for Dr. Sacks to assert

that it disproves it.” (PX0355 (Ornish, Dep. at 192-93)).

865. Dr. Heber did not consider the results of the Ornish CIMT Study in reaching his conclusions on the adequacy

of Respondents' substantiation, because it was “incomplete.” Dr. Heber observed that the Ornish CIMT Study

“had inadequate power at that number of subjects,” so no conclusions could be drawn from the study. (PX353

(Heber, Dep. at 180-81); Heber, Tr. 2133-34).

*106 866. Dr. Heber opined: “The failure of any clinical trial to show a difference cannot be interpreted as a

negative finding, however. Only a probability that any difference has been excluded can be calculated, using the
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so-called beta type II error calculation, which was not done by Dr. Stampfer.” (PX0192 (Heber Expert Report

at 0053)).

867. Dr. Sacks admits that the lack of statistical significance for a positive result in the Ornish CIMT Study is not

proof of a negative and does not mean pomegranate juice is not beneficial. (Sacks, Tr. 1608-09).

iii. Determination on the Ornish CIMT Study

868. The Ornish CIMT Study does not provide competent and reliable scientific evidence to support claims that

the POM Products treat, prevent or reduce the risk of heart disease. (See F. 849-867).

f. Davidson CIMT Study

869. In 2003, Dr. Liker approached Dr. Davidson about conducting a CIMT study and a brachial artery reactivity

testing study for Respondents. From the beginning, Dr. Liker indicated that the he wanted the study to be

randomized, double-blind, and placebo-controlled. (CX1336 (Davidson, Dep. at 92-93); CX0586).

870. In a summary of cardiovascular studies sent to a scientific consultant for POM, Dr. Liker described the

Aviram ACE/BP Study, the Aviram CIMT/BP Study, the Ornish MP Study (2005), and the unpublished Ornish

CIMT Study, and stated that POM was still exploring its research options “in its efforts to understand whether or

not the consumption of pomegranate juice offers cardiovascular benefits.” (CX0579 at 0003-04).

871. Dr. Davidson conducted two studies for Respondents: (1) Davidson MH., et al., Effects of Consumption

of Pomegranate Juice on Carotid Intima-Media Thickness in Men and Women at Moderate Risk for Coronary

Heart Disease, 104 Am. J. Cardiology 936 (2009) (“Davidson CIMT Study”) (CX1065; see JX0003 ¶ B.17);

and (2) Davidson MH, The Effects of Pomegranate Juice on Flow-Mediated Vasodilation (unpublished, 2004)

(“Davidson BART/FMD Study”) (CX0684; see JX0003 ¶ B.17). The cost for the two studies, sponsored by the

Stewart and Lynda Resnick Revocable Trust, was $2,940,494. (CX1134 at 0001).

i. About the Davidson CIMT Study

872. The Davidson CIMT Study was an 18-month, 289-person randomized, double-blinded, placebo-controlled

clinical trial conducted at two clinical research sites in accordance with good clinical practice guidelines and under

a protocol approved by an institutional review board. (PX0014 at 0001-02).

873. The Davidson CIMT Study was designed to test the effect of pomegranate juice on CIMT progression rates

in subjects at moderate coronary heart disease risk. (PX0014 at 0001-02).

874. The Davidson CIMT Study analyzed the results of 289 persons, but actually screened and enrolled 876 and

383 subjects, respectively. (PX0014 at 0002; CX1065 at 0001; CX1291 (Sacks Expert Report at 0027)).

875. Participants in the Davidson CIMT Study were middle-aged men and women with one or more coronary heart

disease risk factors (high LDL, low HDL, hypertension or use of hypertension medication, or cigarette smoking)

and were required to have a baseline posterior wall common CIMT measurement of > 0.7 and < 2.0 mm on # 1

side (right or left). The study excluded persons with actual coronary heart disease or diabetes. (PX0014 at 0002;

CX1065 at 0001-02; CX1291 (Sacks Expert Report at 0027)).
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*107 876. Participants in the Davidson CIMT Study drank eight ounces of pomegranate juice or placebo juice

daily. Adherence to study product consumption was assessed at each visit by reviewing daily consumption diaries

maintained by the subjects. (CX1065 at 0002).

877. The protocol for the Davidson CIMT Study called for ultrasound testing of the carotid artery at baseline,

at 12 months, and at 18 months. (CX0716 at 0018-19). The primary outcome variable identified in the protocol

was the difference between placebo and pomegranate juice in posterior wall common CIMT progression rate in

mm/year, using non-contrast images, and a secondary outcome measurement was the difference between placebo

and pomegranate juice in the anterior wall common CIMT progression rate in mm/year, using contrast images.

(CX0716 at 0028). Exploratory endpoints included changes in blood pressure, lipids, and various measures of

inflammation and oxidative stress. (CX0716 at 0011; CX1291 (Sacks Expert Report at 0027)).

878. The Davidson CIMT Study indicated the following:

• With the exception of apolipoprotein-B100, which decreased more with pomegranate juice than with control ...,

there were no differences between treatment groups for changes from baseline in traditional cardiovascular risk

markers, including fasting lipoprotein lipids, blood pressures, or smoking status (data not shown).

• Of the 152 subjects (52%) agreeing to the optional administration of intravenous contrast agent for anterior wall

imaging, as expected, baseline values for the anterior wall of the common carotid artery were larger than for the

posterior wall.

• Anterior and posterior wall CIMT values and progression rates did not differ significantly between treatment

groups at any time point.

• The composite measurement of CIMT showed a significantly smaller value at 12 months in the pomegranate

juice group compared to the control group ... However, this difference was no longer significant at the end of

the treatment period.

• Exploratory analyses of several subgroups indicated significantly lower values for pomegranate juice versus

control after treatment for anterior wall and/or composite CIMT values: subjects in the top tertiles for baseline

triglycerides (TG), ... total cholesterol/HDL cholesterol ratio ...; composite ..., TG/HDL cholesterol ratio ... and

apolipoprotein-B100 and the lowest tertile for HDL cholesterol. There were no significant differences between

treatments in any of these subgroups at baseline for any CIMT measurements or after treatment in posterior wall

CIMT values.

• Results of the present study showed no significant influence of 18 months of pomegranate juice consumption

on CIMT progression in the overall study sample. However, results from post hoc exploratory analyses, which

should be interpreted with caution, suggest that the rate of CIMT progression may have been slowed in subgroups

characterized by more rapid CIMT progression, including those with increased levels of TG-rich lipoproteins, low

levels of HDL cholesterol, and greater oxidative stress.

*108 • Whether possible benefits of pomegranate juice consumption on CIMT progression in some subgroups

relate to antioxidant activity is uncertain. A lack of significant improvements in most markers of oxidative stress

argues against an important role for antioxidant activity. However, specific reactive oxygen/nitrogen species may

be scavenged by pomegranate unique polyphenolic hydrolysable tannins. Indeed, a subgroup for whom there was

an apparent benefit was the top tertile for baseline PD — AAPH, suggesting that antioxidant effects may have

played a role in the protection against CIMT progression by pomegranate juice consumption.
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• Pomegranate juice and/or polyphenol consumption might favorably influence CIMT progression through effects

on platelet activity, endothelial function, or shifts in the production of prostacyclin production. However, because

none of these variables were measured in the present trial, their potential roles here are unknown.

(PX0014 at 0005-06).

879. The Davidson CIMT Study included a post hoc analysis of changes in the CIMT measurements for some of the

study subpopulations and stated that there were significantly lower anterior and/or composite CIMT progression

rates with higher CVD risk factors. (CX1065 at 0001, 0006; CX1336 (Davidson, Dep. at 57-69)).

880. Dr. Davidson initially submitted a manuscript of the study to the journal, Arteriosclerosis, Thrombosis, and

Vascular Biology, in late 2008. That journal rejected the manuscript, concluding that it was a negative study.

(CX1336 (Davidson, Dep. at 202-03) (discussing CX1016)).

881. In May 2009, Dr. Davidson submitted the manuscript (F. 880) to the American Journal of Cardiology. Two

expert reviewers provided recommendations and comments. (CX1336 (Davidson, Dep. at 77-78); see CX1057

at 0024-27).

882. One reviewer of the manuscript (F. 880) stated that, given the large number of post hoc analyses performed,

it would be appropriate to conduct a statistical correction for multiple comparisons. (CX1057 at 0025; CX1336

(Davidson, Dep. at 80-81)). Dr. Davidson did not do the statistical correction, but committed to revise the

discussion section to emphasize “[t]he possibility of type I errors, the exploratory nature of these findings, and

caution regarding interpretation of post-hoc subgroup analyses.” (CX1336 (Davidson, Dep. at 73); CX1057 at

0025).

883. Another reviewer of the manuscript (F. 880) advised that “The study needs to be reported as a negative study

as it is.” (CX1057 at 0027). In response, Dr. Davidson “affirm[ed] that it was a negative study,” and committed to

revise the manuscript to emphasize that “caution is warranted” with regard to the subgroup findings, and that those

findings “should be considered hypotheses that will need to be replicated in future trials designed to assess the

efficacy of pomegranate juice consumption” in those subgroups. (CX1336 (Davidson, Dep. at 78-85); CX1057

at 0027).

ii. Experts' analysis of the Davidson CIMT Study

*109 884. Dr. Sacks testified that the Davidson CIMT Study is the largest of the heart studies conducted on

pomegranate juice; was carefully designed, in that the protocol identified the endpoints to be measured, the

procedures to be followed, inclusion and exclusion criteria, and the statistical analysis to be conducted; and that

there was no evidence of critical problems in the conduct or analysis of the study (except its over-emphasis on

the subgroup results). Dr. Sacks concluded that the Davidson CIMT Study is “competent and reliable evidence

that consumption of pomegranate juice did not improve CIMT in subjects with one or more cardiovascular risk

factors.” (CX1291 (Sacks Expert Report at 0029)).

885. Dr. Ornish and Dr. Heber testified that the Davidson CIMT Study constitutes competent and reliable evidence

that the consumption of POM Juice is beneficial to cardiovascular health by, among other things, reducing arterial

plaque. (PX0025 (Ornish Expert Report at 0019-22); PX0192 (Heber Expert Report at 0039, 0053); Heber Tr.

1979-86; PX0014).
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886. In his expert report, Dr. Sacks expressly stated the following regarding the Davidson CIMT Study:

• According to the Davidson [C]IMT report, at the end of the study, there were no significant differences in CIMT

progression rates between the subjects in the pomegranate juice and control groups.

• The “composite rate” for all measured carotid artery walls had shown a significantly smaller value at 12 months

in the pomegranate juice group, but this difference was no longer significant at the end of the study.

• Further, the anterior wall values and rates, and the posterior wall values and progression rates did not differ

significantly at any point in the trial.

• There were also no statistically significant changes in the measured indicators of inflammation and oxidative

stress, or in fasting lipoprotein lipids or blood pressure.

(CX1291 (Sacks Expert Report at 0028)).

887. Dr. Ornish agreed with Dr. Sacks' conclusion that the Davidson CIMT Study showed no significant

differences in the overall CIMT progression rates between the active and placebo groups at 18 months. (PX0025

(Ornish Expert Report at 0019-20)).

888. In his expert report, Dr. Ornish expressly stated the following regarding the Davidson CIMT Study:

• the fact that these differences in CIMT measurements were not statistically significant at 18 months does not

change the fact that these differences were statistically significant after 12 months;

• the bottom line is that pomegranate juice did show a statistically significant improvement in CIMT after 12

months in the measure that was most clinically relevant; and

• the Davidson CIMT Study does provide supporting evidence that there was statistically significant lower CIMT

progression rates for pomegranate versus control subjects in those with higher cardiovascular disease risk factors.

(PX0025 (Ornish Expert Report at 0020-22)).

*110 889. Dr. Heber acknowledged that the results at 18 months suggest that in subjects at risk with moderate

coronary heart disease, pomegranate juice consumption had no significant effect on overall CIMT progression

rate, opining as follows:

• No significant difference in overall CIMT progression rate was observed between pomegranate juice and control

treatments.

• In exploratory analyses, in subjects in the most adverse tertiles for baseline serum lipid peroxides, triglycerides

(TGs), high-density lipoprotein (HDL) cholesterol, TGs/HDL cholesterol, total cholesterol/HDL cholesterol, and

apolipoprotein-B100, those in the pomegranate juice group had significantly less anterior wall and/or composite

CIMT progression versus control subjects.
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• In conclusion, these results suggest that in subjects at moderate coronary heart disease risk, pomegranate juice

consumption had no significant effect on overall CIMT progression rate, but may have slowed CIMT progression

in subjects with increased oxidative stress and disturbances in the TG-rich lipoprotein/HDL axis.

(PX0192 (Heber Expert Report at 0039)).

890. Dr. Ornish opined that a potential reason for lack of a change in the CIMT progression rate at 18 months

was that participants in the Davidson CIMT Study may have stopped drinking the juice after 12 months. In his

34 years of directing RCTs, Dr. Ornish notes that it is very challenging to motivate patients to continue following

any intervention for more than one year. Dr. Ornish further observes that it is not unusual for patients to be less

than honest in describing their compliance as patients often describe that it is embarrassing and even humiliating

to report that they have not done what they were supposed to do. (PX0025 (Ornish Expert Report at 0020-21);

PX0355 (Ornish, Dep. at 202-03)).

891. Dr. Davidson evaluated the compliance with product consumption guidelines during the Davidson CIMT

Study. He testified that his review of compliance diaries showed high levels of compliance with product

consumption. (CX1336 (Davidson, Dep. at 151-52); CX0788).

892. Dr. Stampfer provided the opinion that that the main result from the Davidson CIMT Study (2009) provides

substantial evidence against the hypothesis that pomegranate juice can reduce the progression of CIMT. (CX1293

(Stampfer Expert Report at 0020-21); Stampfer, Tr. 758-59 (“So it seems clear that this is a null study, and that's

what the authors concluded”)).

893. Dr. Heber expressly disagrees with Dr. Stampfer's conclusion in (F.892) above: Dr. Stampfer contends

that the CIMT benefit demonstrated in the subgroup of individuals at increased oxidant stress with increased

triglycerides and low HDL does not override his conclusion that “the main result from this large trial provides

substantial evidence against the hypothesis that pomegranate juice can reduce progression of CIMT.” I disagree.

The subgroup data is particularly important because the CIMT benefit was associated with the specific subgroup

that had increased risk factors. (PX0192 (Heber Expert Report at 0053)).

*111 894. The Davidson CIMT Study included a post hoc analysis of changes in the CIMT measurements

for some of the study subpopulations. The Davidson CIMT Study described the subgroup analyses as “post

hoc exploratory analyses, which should be interpreted with caution[.]” It stated that, “[b]ecause the decrease in

CIMT progression in these subgroups was based on analyses that were not preplanned and had no correction for

multiple comparisons ..., these findings will need to be confirmed in future investigations.” (CX1065 at 0001,

0006; CX1336 (Davidson, Dep. at 57-69)).

895. A post hoc analysis is one that is conceived after the researchers have seen the data and, thus, is generally a

less valid approach than one planned for in the protocol, because it is more subject to bias. (Sacks, Tr. 1500-01).

896. Respondents' experts opined that in scientific research, post hoc analysis is routine. (Heber, Tr. 1984).

Although the exploratory analysis was not called for by the protocol, such analyses, including those on subgroups,

are commonly done. (CX1336 (Davidson, Dep. at 57, 221)).

897. With respect to the Davidson CIMT Study, Dr. Ornish opined: “While this is post hoc analysis, and thus not

as rigorous as one stated a priori, it does provide supporting evidence that there was statistically significant lower
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CIMT progression rates for pomegranate versus control subjects in those with higher cardiovascular disease risk

factors.” (PX0025 (Ornish Expert Report at 0021)).

898. Dr. Sacks also noted that the subgroup analysis had not been corrected for multiple comparisons, as stated

in the Davidson CIMT Study. (CX1291 (Sacks Expert Report at 0030)). When multiple endpoints are being

measured, the p-value needs to be adjusted downward to correct for multiple comparisons. Without the correction,

with each additional subgroup analyzed, the chances increase that one or more will turn out to have a p-value of

less than .05, by chance alone. (Sacks, Tr. 1505-06; Stampfer, Tr. 760-61). Dr. Davidson never did a correction

for multiple comparisons on the subgroup analysis. (CX1336 (Davidson, Dep. at 73)).

899. Dr. Sacks further opined: because the subgroup data is hypothesis generating only, and has not been corrected

for multiple comparisons, a qualified scientist could not rely on the post hoc analysis of the subgroup populations

as reliable scientific evidence to support claims that POM Juice or POMx prevent, reduce the risk of, or treat heart

disease in the subpopulations identified in Figure 3 of the Davis CIMT Study. (CX1291 (Sacks Expert Report

at 0029-30)).

iii. Determination on the Davidson CIMT Study

900. The Davidson CIMT Study does not provide competent and reliable scientific evidence to support claims

that the POM Products treat, prevent or reduce the risk of heart disease. (See F. 872-899).

g. Davidson BART/FMD Study

i. About the Davidson BART/FMD Study

901. The brachial artery is a major blood vessel of the arm. Brachial artery reactivity testing (“BART”) is a

measurement of how much the brachial artery dilates (enlarges) after a blood pressure cuff is inflated, and then

released. This is also called flow mediated dilation (“FMD”) testing. (JX0003 ¶ A.1-2; CX1336 (Davidson, Dep.

at 34-35)).

*112 902. Flow mediated dilation is the amount by which the brachial artery dilates (gets larger) after the blood

pressure cuff is deflated. (JX0003 ¶ A.8).

903. Dr. Davidson conducted the Davidson BART/FMD Study on a subset of 45 Davidson CIMT Study

participants. It was a 13-week, randomized, double-blind, placebo-controlled trial to evaluate the effect of

consuming POM Juice or placebo on BART, also referred to as FMD testing. (JX0003 ¶ A.1; CX0684; CX0716

at 0010-11, 0074-81; CX1336 (Davidson, Dep. at 37, 102-03); Sacks, Tr. 1508-10; Stampfer, Tr. 764-66).

904. At the conclusion of the Davidson BART/FMD Study, there were no significantant differences between the

treatment and placebo groups and no written report was prepared. (PX0019; CX0684 at 0001; CX1336 (Davidson,

Dep. at 87-89); Sacks, Tr. 1510-13; CX1291 (Sacks Expert Report at 0030-31); CX1293 (Stampfer Expert Report

at 0021); CX0695 at 0001; CX1336 (Davidson, Dep. at 125)).

905. The Davidson BART/FMD Study also took measurements of blood pressure and other vital signs. However,

blood pressure, cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, ACE, paraoxonase (PON), and

thiobarbituric acid reactive substances (TBARS) were not primary or secondary endpoints of the Davidson BART/

FMD Study. (CX0684; CX0716 at 0010-11, 0074-81; Sacks, Tr. 1508-10; Stampfer, Tr. 764-66).
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906. At the end of the Davidson BART/FMD Study, there were no significant differences between treatment and

placebo groups in blood pressure, cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, ACE, PON,

and two TBARS measurements. (CX1336 (Davidson, Dep. at 86-88; CX0684 at 0005-13, 0019; CX1291 (Sacks

Expert Report at 0031)).

ii. Experts' analysis of the Davidson BART/FMD Study

907. Complaint Counsel's expert, Dr. Sacks, opined that the Davidson BART/FMD Study appears to have been

properly designed and conducted. The protocol identifies the endpoints to be measured, the procedures to be

followed, inclusion and exclusion criteria, and the statistical analysis to be conducted. There is no indication of

critical problems in the conduct of the study. (CX1291 (Sacks Expert Report at 0032)).

908. Dr. Sacks opined that although BART/FMD is not a valid or generally recognized surrogate marker of

coronary heart disease, it does provide relevant information because FMD is a measure of nitric oxide. Dr. Sacks

further opined that if pomegranate juice meaningfully affected nitric oxide metabolism, one would have expected

to see a positive result in the FMD testing. (CX1291 (Sacks Expert Report at 0032); Sacks, Tr. 1510-12).

909. Dr. Sacks further opined that the Davidson BART/FMD Study finding of no statistically significant difference

in blood pressure or ACE due to POM Juice consumption is inconsistent with Dr. Aviram's ACE/BP Study

findings. (F. 774-779; Sacks, Tr. 1512-13; CX1291 (Sacks Expert Report at 0032)).

910. Dr. Heber testified that in the Davidson BART/FMD Study, the primary endpoint was flow-mediated dilation,

not blood pressure, and, therefore, any results for blood pressure cannot be relied upon as negative evidence.

(Heber, Tr. 2106-07).

*113 911. Dr. Sacks concedes that just because the Davidson BART/FMD Study does not show statistically

significant changes with respect to blood pressure and ACE, among other measurements, the absence of such

evidence is not proof there is no effect. (PX0361 (Sacks, Dep. at 230)).

912. Respondents' experts explain that the absence of evidence is not evidence of absence, so the fact that a

statistically significant change in ACE or blood pressure was not found does not mean that the result does not

exist. (Heber, Tr. 1981; see also Sacks, Tr. 1608).

913. Respondents' experts opined that no conclusion can be drawn from the absence of statistically significant

changes in the Davidson BART/FMD Study. (Heber, Tr. 1981; Sacks, Tr. 1608-09).

iii. Determination on the Davidson BART/FMD Study

914. The Davidson BART/FMD Study does not constitute competent and reliable scientific evidence supporting

a claim that the POM Products treat, prevent or reduce the risk of heart disease. (See F. 903-913)

6. Additional biomarker studies sponsored by Respondents

a. The Overweight Studies
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915. In 2006, POM sponsored Dr. James Hill, University of Colorado, Denver, to examine the safety and

antioxidant activity of POMx on overweight individuals with increased waist size (“Denver Study”). Also in 2006,

POM sponsored Dr.Heber and Accelovance to study the safety of POMx and the effect of POMx on biomarkers

and inflammation in overweight people (“San Diego Study”) (collectively, the “Overweight Studies”) (CX0934;

CX0819 at 0021-22; CX0859 at 0001).

i. About the Denver Study

916. In 2006, Dr. Hill and his colleagues conducted an unblinded, uncontrolled study of POMx capsules in Denver,

Colorado, known as the Denver Study. (CX1291 (Sacks Expert Report at 0032-35); see Sacks, Tr. 1513-14).

917. The Denver Study enrolled 24 adults (19 females, 5 males) ages 40 to 70 with abdominal adiposity. Subjects

received two POMx capsules per day for 28 days. (CX0877 at 0002-10; CX0934 at 0003-04).

918. The Denver Study measured a “wide range of biomarkers for oxidative stress and inflammation” at baseline

and at four weeks, including TBARS (thiobarbituric acid reactive substances) and PON1 activity. TBARS is an

important biomarker of oxidative stress in humans and strongly predictive of cardiovascular events in people

with stable coronary artery disease, independent of traditional risk factors and inflammatory markers. Highdensity lipoprotein cholesterol (“HDL” or so called “good cholesterol”) contains an antioxidant enzyme, called

“paraoxonase” or “PON1” which acts to protect the body against oxygen radicals. Additional measurements

included blood pressure, triglycerides, cholesterol, and C-reactive protein. Although the subjects' triglycerides,

cholesterol, and C-reactive protein were measured, the study was not designed to assess those factors. (CX0877

at 0002-10; CX1342 (Hill, Dep. at 42-44); Heber, Tr. 1961; CX0934 at 0003-04).

*114 919. Twenty-two subjects completed the Denver Study. According to the Preliminary Data Analysis, dated

February 15, 2007, the participants gained an average of 1.3 pounds during the study, which Dr. Hill attributed to

its being conducted during the holiday season. (CX0877 at 0002-03; CX1291 (Sacks Expert Report at 0032-33);

CX1342 (Hill, Dep. at 99-103)).

920. TBARS was the primary endpoint chosen to assess the antioxidant activity of the POMx capsules in the

Denver Study. (CX1342 (Hill, Dep. at 41-42)). The authors of the study concluded that POMx is safe and that

there was evidence of antioxidant activity through a significant reduction in TBARS linked with cardiovascular

disease risks. (CX0934 at 0004).

921. After adjusting the statistical analysis for the weight change, during the Denver Study TBARS decreased and

free fatty acids increased. The study statistician stated that the change in TBARS was “of borderline significance

[and had] not been adjusted for the number of comparisons made.” (CX0877 at 0002-03, 0008 (TBARS); CX1291

(Sacks Expert Report at 0032-33)).

922. In the Denver Study, there was no change in PON1 and there were no statistically significant changes in

blood pressure. The subjects' blood pressure was taken as a safety measure to protect the subjects, as the study

was not designed to assess whether or not POMx capsules had an effect on blood pressure. (CX0877 at 0002-03,

0008, 0010; CX1291 (Sacks Expert Report at 0032-33); CX1342 (Hill, Dep. at 71-72, 97-103, 111-13, 118-19).

923. Although inflammation was not explored as the primary endpoint, the Denver Study concluded, “[w]e did

not detect any effect of POMx on inflammation but identification of better biomarker assays for inflammation is

needed .... [T]his pilot project suggests that a larger trial is warranted in abdominally obese subjects who may be
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at risk for development of metabolic diseases.” (CX0877 at 0002-03; CX1291 (Sacks Expert Report at 0032-33);

CX1342 (Hill, Dep. at 41-42); CX0934 at 0001).

ii. About the San Diego Study

924. The protocol for the San Diego Study was titled, A Placebo-Controlled, Randomized, Double-Blind Study

to Compare Antioxidant Levels in Normal Subjects with Elevated Waist Circumference When Administered 1 or

2 Pomegranate Dietary Supplement Capsules for 4 Weeks. (CX0819 at 0014 (Protocol, July 14, 2006); CX1291

(Sacks Expert Report 0033-34)).

925. The San Diego Study was designed as a safety assessment. (CX0934 at 0001).

926. The San Diego Study recruited 64 generally healthy male and female subjects who took either two POMx

capsules, two placebo capsules, or one placebo and one POMx capsule, per day, for four weeks. (CX0859 at 0010

(Clinical Study Report); CX1291 (Sacks Expert Report at 0033-34)).

927. Measurements in the San Diego Study included blood pressure, oxidized phospholipids, oxidized LDL/HDL,

serum nitric oxide, and PON, but these were not primary endpoints. (CX0934 at 0001; CX0859 at 0003; CX1291

(Sacks Expert Report at 0033-34)).

*115 928. A portion of the San Diego Study data was presented in a January 11, 2007 Clinical Study Report.

(See CX0859). This document described the conduct of the study, adverse events, vital signs, and blood pressure

data. It stated that “[t]here were no apparent treatment related changes in weight, systolic blood pressure, diastolic

blood pressure, pulse rate, respirations, or temperature.” The San Diego Study report also stated that the efficacy

results of antioxidant and anti-inflammatory levels were shown separately. (CX0859 at 0018, 0020).

929. Dr. Heber prepared a slide presentation about the results of the San Diego Study in which he stated: “there

were no changes in ... markers of oxidative stress or inflammation that were studied,” including in C-reactive

protein, oxidized phospholipids, lipoprotein (a), and nitric oxide and that “[t]he variation among subjects suggests

that a more focused study would be more likely to demonstrate significant changes.” (CX1254 at 0026; CX1254

at 0001, 0006-26; Heber, Tr. 2119-21).

930. Dr. Heber sent this presentation (F. 929) to POM employees on January 9, 2007 with an accompanying

email stating, “we have not proved or disproved efficacy at this point.” By efficacy, Dr. Heber meant changes in

biomarkers of oxidant stress or inflammation. (CX0858 at 0001). (CX1352 (Heber, Dep. at 107-11) (discussing

CX1254)).

931. Dr. Heber's article on the San Diego Study results was published in late 2007 as Heber D. et al., Safety

and Antioxidant Activity of a Pomegranate Ellagitannin-Enriched Polyphenol Dietary Supplement in Overweight

Individuals with Increased Waist Size, J. Agric Food Chem., Vol. 55, No. 24 (2007). (See CX0934).

932. Dr. Hebers's article (F. 931) on the Overweight Studies stated that “[p]reliminary evidence of a reduction in

TBARS was seen in the subjects who were studied at the Denver site .... TBARS are an important biomarker of

oxidative stress .... [T]hese pilot studies demonstrate both the safety and efficacy of POMx ... in humans. However,

further studies need to be done to confirm the antioxidant properties of pomegranate ellagitannins administered

as a dietary supplement.” (CX0934 at 0003-04).
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933. Dr. Heber acknowledged that the published article (F. 931) did not provide all of the results of the San Diego

Study, including those concerning antioxidant stress or inflammation. Dr. Heber explained that the San Diego

Study was primarily studying safety, “with the idea that we would explore the idea of whether any inflammatory

markers or oxidant stress markers were elevated in those subjects.” Dr. Heber further stated that they found that

the studied population had a “great deal of variability” at baseline and four-week measurements. Dr. Heber further

explained that there was no interest in publishing the results because the findings concerning anti-inflammatory

effects were “indeterminate results, not negative results.” (Heber, Tr. 2116-17).

iii. Experts' analysis of the Overweight Studies

*116 934. Drs. Sacks and Stampfer concluded that the methodological shortfalls in the Denver Study —

especially the lack of a control group — render its findings unreliable. (CX1291 (Sacks Expert Report at 0035);

see also Sacks, Tr. 1519-21; Stampfer, Tr. 768-72).

935. Dr. Ornish agreed that there are limitations to the Denver Study and that it was a pilot study, which only

provides preliminary findings to justify doing a larger study. Dr. Ornish further opined that the San Diego Study

did not demonstrate efficacy since there were no significant changes in biomarkers. (PX0025 (Ornish Expert

Report at 0024-25)).

936. Dr. Heber stated in his expert report that the Denver Study demonstrated the efficacy of POMx as

an antioxidant. (CX0934 at 0004). At trial, however, he described the Denver Study as a “pilot study ...

not a conclusive demonstration.” (Heber, Tr. 2116). Dr. Heber explained, anti-inflammatory effects “were

indeterminate results, not negative results.” (Heber, Tr. 2117).

937. With respect to the lack of statistically significant changes to blood pressure and other biomarkers, such as

triglycerides, HDL, LDL, C-reactive protein, and PON, Dr. Sacks acknowledges that the absence of information

does not prove the negative. (PX0361 (Sacks, Dep. at 223-24, 238, 243)).

iv. Determination on the Overweight Studies

938. The Overweight Studies do not constitute competent and reliable scientific evidence to support claims that

the POM Products treat, prevent or reduce the risk of heart disease. (See F. 915-937).

b. The Diabetes Studies

i. About the Diabetes Studies

939. Respondents have also sponsored studies evaluating the effect of pomegranate juice and/or its derivatives on

persons with diabetes, discussed below, (collectively, “the Diabetes Studies”). (PX0038; PX0127; CX0765).

940. The first of the Diabetes Studies, conducted by Dr. Rock, a member of Dr. Aviram's team, published as

Rock, W, et al., Consumption of Wonderful Variety Pomegranate Juice and Extract by Diabetic Patients Increases

Paraoxonase I Association with High-Density Lipoprotein and Stimulates Its Catalytic Activities, 56 J. Agric.

Food Chem. (2008), looked at the relationship of PON1 and HDL cholesterol activity in 30 diabetic patients who

used pomegranate juice or POMx Liquid for four to six weeks. It indicated a reduction in oxidative stress as
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measured by TBARS and improved PON. All measurements were comparisons to baseline. (PX0127; CX1291

(Sacks Expert Report at 0036-37); PX0192 (Heber Expert Report at 0038-39)).

941. The other two Diabetes Studies were conducted by Dr. Heber and Dr. Hill and were randomized, double-blind,

placebo-controlled studies to evaluate the antioxidant effect of pomegranate extract capsule and pomegranate

juice, respectively, in diabetic patients. (Heber, Tr. 2048-49, 2054; CX1352 (Heber, Dep. at 124-25); CX0949 at

0007-26 (protocol for diabetes extract study); CX1082 at 0007-21 (protocol for diabetes juice study); CX1284).

*117 942. The POMx protocol called for enrolling 30 diabetics for 12 weeks. (CX949 at 0013). The POM Juice

study protocol called for an enrollment of 40 diabetics for 12 weeks. (CX1082 at 0012).

943. The two Diabetes Studies conducted by Dr. Heber and Hill were completed, but the results were not published.

(CX1352 (Heber, Dep. at 132-33); CX1342 (Hill, Dep. at 157)).

ii. Experts' analysis of the Diabetes Studies

944. Dr. Sacks testified that the Diabetes Studies do not constitute competent and reliable scientific evidence to

support claims that POM Juice or POMx treat, prevent, or reduce the risk of heart disease because they are not

RCTs, the study size is too small, and the duration is too limited in scope. (CX1291 (Sacks Expert Report at

0035-37); Sacks, Tr. 1521-24).

945. According to Dr. Heber, the two diabetes studies he conducted did not show a significant change in

malondialdehyde, which is a TBARS measure, or in PON, both of which are heart-related biomarkers. (Heber,

Tr. 2124 (malondialdehyde), 2137-38 (PON); CX1352 (Heber, Dep. at 161-70)).

946. Dr. Heber did not include the results of his two diabetes studies in his analysis of available human clinical

evidence to substantiate heart benefits of POM Products. (PX0192 (Heber Expert Report at 0052-54)).

iii. Determination on the Diabetes Studies

947. The Diabetes Studies do not constitute competent and reliable scientific evidence to support claims that the

POM Products treat, prevent or reduce the risk of heart disease. (See F. 939-946).

7. Experts' opinions based on the totality of the evidence

a. Summary of Complaint Counsel's experts' opinions

948. Dr. Sacks and Dr. Stampfer both opined that Respondents' research on pomegranate juice provides no

evidence that POMx Pills or POMx Liquid will treat, prevent, or reduce the risk of heart disease or that they are

clinically proven to do so. (CX1291 (Sacks Expert Report at 0010, 0038); CX1293 (Stampfer Expert Report at

0017)).

949. Dr. Stampfer opined: Respondents' human clinical studies, including a large randomized clinical trial, failed

to confirm the results of the animal and in vitro studies. Although some promising results appear in several of the

smaller studies with important design limitations, the weight of the evidence strongly favors the null hypothesis
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of no effect .... The current data does not support the claims for heart disease prevention or treatment. (CX1293

(Stampfer Expert Report at 0022)).

950. Dr. Sacks opined: the evidence is not sufficient to support the conclusion that consumption of POM Juice,

POMx Pills, or POMx Liquid treat, prevent, or reduce the risk of heart disease. (CX1291 (Sacks Expert Report

at 0038-39)).

951. Dr. Sacks further opined: there is no reliable evidence that POM Juice, POMx Pills, or POMx Liquid reduce

or delay the development of arterial plaque; improve blood flow to the heart (or other blood vessels); or reduce

blood pressure. (CX1291 (Sacks Expert Report at 0038-39)).

*118 952. Dr. Sacks opined, in addition, that clinical studies, research and/or trials do not prove that drinking

POM Juice or taking one POMx Pill or one teaspoon of POMx Liquid, daily, prevents or reduces the risk of or

treats heart disease, including by decreasing arterial plaque, lowering blood pressure, and/or improving blood flow

to the heart. (CX1291 (Sacks Expert Report at 0010)).

b. Summary of Respondents' experts' opinions

953. Dr. Heber opined that based on basic scientific studies focusing on the hydrolysable tannins family, especially

punicalagins and ellagitannins, POMx Pills and POMx Liquid are equivalent to POM Juice in providing health

benefits to humans. (Heber, Tr. 2002-03; see also Heber, Tr. 2186-87 (studies show there is no difference between

the antioxidant effect in pomegranate juice and that in POMx and that pomegranate juice and POMx have the

same impact on oxidative stress)).

954. Dr. Heber also opined: the body of research on pomegranate juice and extract provides support for potential

heart benefits for heart disease. (PX0192 (Heber Expert Report at 0015)).

955. Dr. Heber, in addition, opined that competent and reliable evidence shows that POM and POMx are likely

to reduce the risk of cardiovascular disease. (Heber, Tr. 2012, 2087).

956. Dr. Heber further opined: there is credible scientific evidence that pomegranate juice and pomegranate

extracts have significant health benefits for human cardiovascular systems, including: (1) decreases in arterial

plaque; (2) lowering of blood pressure; and (3) improvement of cardiac blood flow, based on the biological

mechanism of prolonging the half-life of nitric oxide in the vasculature. (PX0192 (Heber Expert Report at

0044-45)).

957. Dr. Heber also stated in his expert report that he agreed with Dr. Stampfer that “claims that pomegranate juice

and extract have not been proven absolutely effective to treat, prevent, or reduce the risk of heart disease ... based

solely on evidence from large double-blind placebo-controlled trials ... But the entire body of scientific evidence

should be considered when evaluating nutritional science.” (PX0192 (Heber Expert Report at 0044)).

958. Dr. Ornish opined that in evaluating scientific research related to a whole food, as opposed to a drug, it is not

necessary to reach statistical significance to convey information about the product; the convention of a finding

that there be a five percent or less likely due to chance finding is an arbitrary convention; and that when you have

a p-value of 0.05, there is a 95 percent probability of validity as opposed to chance and when you have a p-value

of 0.058, there is a 94 percent validity as opposed to chance. (Ornish, Tr. 2340).
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959. Dr. Ornish opined: taken as a whole, the preponderance of the scientific evidence from basic scientific studies,

animal research, and clinical trials in humans reveals that the pomegranate in its various forms (including POM

Wonderful 100% Pomegranate Juice, POMx Pills, or POMx Liquid) is likely to be beneficial in maintaining

cardiovascular health and is likely to help reduce the risk of cardiovascular disease. (PX0025 (Ornish Expert

Report at 0005)).

*119 960. Dr. Ornish also opined: the universe of existing science provides significant evidence that pomegranate

juice is likely to (1) reduce arterial plaque, (2) improve blood flow, and (3) reduce blood pressure. (PX0025

(Ornish Expert Report at 0005); PX0355 (Ornish, Dep. at 42); Ornish, Tr. 2374-75).

8. Conclusions

961. In considering whether a conventional food or dietary supplement is likely to have an effect on the risk or

treatment of a disease, it is important to first look at the individual items of evidence, to determine whether they

are reliable and probative. Then, it is important to look at the evidence as a whole. (CX1291 (Sacks Expert Report

at 0038)).

962. There is insufficient competent and reliable scientific evidence to support the conclusion that the POM

Products treat, prevent, or reduce the risk of heart disease, including by decreasing arterial plaque, lowering blood

pressure, and/or improving blood flow to the heart; no clinical studies, research and/or trials prove these effects.

(CX1291 (Sacks Expert Report at 0010, 0038-39); CX1293 (Stampfer Expert Report at 0022)).

H. Substantiation for Respondents' Prostate Cancer Claims

1. Substantiation standard for prostate claims

963. Because pomegranate juice is derived from a fruit, is known to be safe, and is not a pharmaceutical drug,

physicians who treat patients concerned with prostate health would not hold pomegranate juice to the standards

of safety and efficacy traditionally required by the FDA for approval of a pharmaceutical (performance of a

large, randomized, double-blind, placebo controlled clinical trial) before recommending pomegranate juice to

their patients. (PX0206 (Miller Expert Report)).

964. A claim that a fruit juice that is known to be safe, treats or prevents prostate cancer, if not offered as a

substitute or a replacement for a conventional therapy, can be supported if there is reliable and competent scientific

data that support the claimed beneficial effect. (PX0206 (Miller Expert Report at 11); Miller, Tr. at 2201).

965. Experts in the field of prostate health would not require RCTs to substantiate health benefit claims for

harmless pure fruit products like pomegranate juice. (deKernion, Tr. 3060; see also Miller, Tr. 2201).

966. Experts in the field of prostate health would require that a product be scientifically evaluated through rigorous

scientific and clinical studies, and believe that animal and in vitro studies alone are not sufficient to conclude that

the POM Products treats, prevents, or reduces the risk of prostate cancer or that they have been clinically proven

to do so. (CX1287 (Eastham Expert Report at 0006, 0012-15); CX1293 (Stampfer Expert Report at 0009-10)).

2. Background facts on prostates and the effects of pomegranates on prostates
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a. Prostate function and prostate cancer

967. The prostate is a gland located in the male pelvis that is an organ of sexual function and fertility. (Eastham,

Tr. 1236).

*120 968. Prostate cancer occurs when cells of the prostate, typically the glandular cells, become cancerous,

which means they have uncontrolled cell growth. (Eastham, Tr. 1236).

969. Last year about 220,000 men were diagnosed with prostate cancer in the United States. Approximately one

in six men over the age of 60 will be diagnosed with prostate cancer each year. The average age of prostate cancer

diagnosis is in the sixties. About 30,000 men die from prostate cancer each year. (Eastham, Tr. 1237-39).

970. Prostate cancer does not have a typical course. There are many prostate cancers that, while they are seen

under the microscope, they do not represent a threat to the life expectancy or the quality of life of the patient.

(Eastham, Tr. 1236).

971. Blood levels of prostate specific antigen (PSA) are measured in healthy men to assess their risk of prostate

cancer. (Stampfer, Tr. 774).

972. PSA is a protein that is derived almost exclusively from the prostate and is widely used for screening for the

risk of prostate cancer. (Stampfer, Tr. 774).

973. PSA is also used after diagnosis of prostate cancer to monitor the progression of disease. (Stampfer, Tr. 774).

974. The two mainstays of cure for prostate cancer are either radical prostatectomy (surgical removal of the

prostate) or radiation therapy to the prostate. (Eastham, Tr. 1237; PX0060 at 0001).

975. Although the mainstays described in F. 974 are adequate for permanent disease control in many patients, a

significant number of patients relapse and ultimately develop metastatic disease. (PX0060 at 0001).

976. Approximately one third of prostate cancer patients with clinically confined cancer that are treated with

radical prostatectomy will develop a biochemical recurrence. (PX0060 at 0001).

977. There are limited treatment options for patients who have undergone primary therapy with curative intent

and who have progressive elevation of their PSA without documented evidence of metastatic disease. (PX0060

at 0002).

978. Androgens are male steroid hormones that regulate prostate cancer cell growth. Hormone-type products

increase testosterone levels and, basically, stop the conversion of testosterone to a more potent hormone, androgen.

Compounds that contain hormonetype products can impact the PSA if they are used in large quantities. (Stampfer

Tr. 773; Eastham Tr. 1242-44).

979. Early initiation of hormonal ablation is associated with significant morbidity and effect on quality of life,

including fatigue, hot flashes, loss of libido, decreased muscle mass, and osteoporosis with long-term use. (PX0060

at 0002).

980. Strategies to delay clinical prostate cancer progression and prolong the interval from treatment failure to

hormonal ablation would be of paramount importance. (PX0060 at 0002).
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981. A combination of epidemiologic and basic science evidence strongly suggests that diet and plant-derived

phytochemicals may play an important role in prostate cancer prevention or treatment. (PX0060 at 0002).

*121 982. Epidemiologic studies suggest that a reduced risk of cancer is associated with the consumption of a

phytochemical-rich diet that includes fruits and vegetables. (PX0060 at 0002).

983. Fresh and processed fruits and food products contain high levels of a diverse range of phytochemicals

of which polyphenols, including hydrolyzable tannins (ellagitannins and gallotannins) and condensed tannins

(proanthocyanidins), and anthocyanins and other flavonoids make up a large proportion. (PX0060 at 0002).

984. Several phytochemicals have been proposed as potential chemoprevention agents based on animal and

laboratory evidence of antitumor effects. (PX0060 at 0002).

985. Suggested mechanisms of anticancer effects of polyphenols include the inhibition of cancer cell growth by

interfering with growth factor receptor signaling and cell cycle progression, promotion of cellular differentiation,

modulation of phosphodiesterase/cyclooxygenase pathways, inhibition of kinases involved in cell signaling, and

inhibition of inflammation. (PX0060 at 0002).

b. Mechanism of action of pomegranates in the prostate

986. The pomegranate (punica granatum L.) fruit has been used for centuries in ancient cultures for its medicinal

purposes. (PX0060 at 0002).

987. Pomegranate fruits are widely consumed fresh and in beverage forms as juice and wines. Commercial

pomegranate juice shows potent antioxidant and antiatherosclerotic properties attributed to its high content of

polyphenols, including ellagic acid in its free and bound forms (as ellagitannins and ellagic acid glycosides),

gallotannins, and anthocyanins (cyanidin, delphinidin, and pelargonidin glycosides) and other flavonoids

(quercetin, kaempferol, and luteolin glycoside). (PX0060 at 0002).

988. Atherosclerosis means a build-up of plaque in arteries. (Stampfer, Tr. 700).

989. The most abundant of the polyphenols in pomegranates is punicalagin, an ellagitannin implicated as the

bioactive constituent responsible for > 50% of the potent antioxidant activity of the juice. Punicalagin is abundant

in the fruit husk and, during processing, is extracted into pomegranate juice in significant quantities reaching

levels of > 2g/L juice. (PX0060 at 0002).

990. Ellagic acid and tannins have been shown previously to exhibit in vitro and in vivo anticarcinogenic properties,

such as induction of cell cycle arrest and apoptosis, as well as the inhibition of tumor formation and growth in

animals. (PX0060 at 0002).

i. In vivo research reporting reduced inflammation in prostate tumors

991. A large body of literature has linked inflammation to prostate carcinogenesis at all stages of the development

of prostate cancer from normal tissue to advanced cancer. (PX0192 (Heber Expert Report at 0029); PX0070 at

0001).
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992. Inflammation in the human is a key step in prostate cancer progression. (CX1352 (Heber, Dep. at 257-58);

PX0070 at 0001).

993. Areas of chronic inflammation are almost universally present in pathologic specimens of the prostate,

including biopsy cores in men prior to the diagnosis of prostate cancer, transurethral resection chips, and total

prostatectomy specimens. (PX0192 (Heber Expert Report at 0029)).

*122 994. Ninety-eight percent of prostate tumors removed at surgery for cancer have evidence of inflammation.

(CX1352 (Heber, Dep. at 257-58); PX0192 (Heber Expert Report at 0029-30)).

995. In vivo research has demonstrated that pomegranate polyphenols reduce inflammation in prostate tumors.

(CX1352 (Heber, Dep. at 257-58); Heber, Tr. 1992).

ii. In vivo research reporting nuclear factor #B decreased

996. One well-established signaling pathway mediating inflammatory responses relevant to cancer is the nuclear

factor-kappaB (NF-#B) pathway. (PX0192 (Heber Expert Report at 0030); deKernion, Tr. 3046-47; Heber, Tr.

1992; PX0070 at 0001).

997. The unique protein NF-#B was the subject of Nobel Prize-winning research by Dr. David Baltimore who

identified the protein's unique ability to both receive a signal from the outside of a cell and translate that signal

into genetic programming of inflammatory proteins that are secreted by cells (“Dr. Baltimore's study”). (PX0192

(Heber Expert Report at 0030); Heber, Tr. 1992).

998. Dr. Baltimore's study involved in vitro and animal research. (PX0192 (Heber Expert Report at 0030)).

999. Dr. Baltimore's study showed that the activity of NF-#B is regulated by another protein inhibitor called I#B,

which binds to and sequesters NF-#B family members in the fluid part of the cell away from DNA, called the

cytoplasm. (PX0192 (Heber Expert Report at 0030); PX0070 at 0001).

1000. Dr. Baltimore's study showed that when the NF-#B pathway is activated, I#B is chemically modified by

an enzyme called I#B kinase, which adds a phosphorus atom at specific amino acids on the IkB protein (serine

residues 32 and 36). (PX0192 (Heber Expert Report at 0030); PX0070 at 0001).

1001. Dr. Baltimore's study showed that once altered, the inhibitory protein I#B is degraded and NF-#B is free

to move to the nucleus, where it functions to activate genetic mechanisms after binding to DNA, resulting in the

secretion of proinflammatory signaling proteins. (PX0192 (Heber Expert Report at 0030); PX0070 at 0001).

1002. Dr. Baltimore's study showed that while normal activation of NF-#>B is temporary in response to a stimulus

meant to activate immune function, constant or constitutive activation has been observed in breast cancer, liver

cancer, melanoma, Hodgkin's disease, and cervical cancer. (PX0192 (Heber Expert Report at 0030); PX0070 at

0001).

1003. Dr. Baltimore's study stated that direct genetic evidence in mouse models of colon and liver cancer have

established that NF-#B activation within tumor cells or infiltrating inflammatory cells is required for tumor

initiation or promotion. (PX0192 (Heber Expert Report at 0030); PX0070 at 0001).
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1004. Dr. Baltimore's study reported that activation of NF-#B is observed in primary prostate cancer specimens as

evidenced by its presence in the nucleus of cells where the genes reside and represents an independent risk factor

for recurrence of prostate cancer after radical prostatectomy. (PX0192 (Heber Expert Report at 0030); PX0070

at 0001).

*123 1005. Dr. Baltimore's study reported that pomegranate extract has been shown to inhibit NF-#B in normal

human cells, including chondrocytes, epidermal keratinocytes, and vascular endothelial cells. (PX0192 (Heber

Expert Report at 0031); PX0070 at 0002).

1006. Dr. Baltimore's study concluded that pomegranate extract inhibits both continuous (constitutive) and

stimulated (cytokineinduced) NF-#B activity in prostate cancer cells in vitro and that the NF-#B inhibitory effect

of pomegranate extract was necessary for the maximal cell killing effects of pomegranate extract. (PX0192 (Heber

Expert Report at 0031); Heber, Tr. 1993; PX0070 at 0002).

1007. Respondents' experts testified that in tumors treated with pomegranate extract, the NF-#B decreased,

therefore causing decrease of tumor growth. (deKernion, Tr. 3046-47; Heber, Tr. 1993).

1008. Respondents' experts testified that there is an absolute linear connection between the polyphenol

mechanisms in pomegranate extract and the decrease in tumor growth. (deKernion, Tr. 3046-47; Heber, Tr. 1993).

1009. The mechanisms of action of the POM Products on inflammation and NF-#>B contributes to the total body

of research relied upon by Respondents. (PX0161 (deKernion Expert Report at 0011-12); PX0192 (Heber Expert

Report at 0031); PX0206 (Miller Expert Report at 12); PX0070).

3. Basic science studies

a. Summary of the studies

1010. Respondents have conducted four in vitro studies and four animal studies relating to prostate cancer,

according to their January 13, 2009 summary of their prostate cancer research to date. (CX1029 at 0004).

1011. POM's initial studies involved in vitro growing of human tumor cells in petri dishes in laboratories, adding

POM and POM products and evaluating the effect on the human tumor cells. These initial studies showed a

significant decrease in growth, increase in apoptosis, (programmed tumor death), and decrease in inflammation,

factors which are all related to cancer. (deKernion, Tr. 3044).

1012. Subsequent research involved in vivo study wherein a human tumor was grown in immune deficient mice,

an environment, which behaves as though it were in a human. In these studies which used LAPC4, a particular

prostate tumor line, researchers demonstrated that when a prostate tumor is grown in mice and pomegranate extract

and pomegranate products are added, the tumors markedly decreased. (deKernion, Tr. 3045). These studies were

not of animal glands, but were studies of human prostate tissue put in animals. All of these studies indicated that

POM had an antitumor effect on human tumors. (deKernion, Tr. 3049).

1013. In 2001, Agensys, a biotech company, performed early preclinical research for POM investigating the

effect of pomegranate juice and prostate cancer. Agensys' unpublished research found that in vitro pomegranate

juice consumption “substantially inhibits the proliferation of prostate cancer cells” and that pomegranate juice

consumption “retards the growth of subcutaneous and orthotopic prostate tumors in mice.” (deKernion, Tr. 3115;

Tupper Tr. 1034; PX0065 at 0036-37).
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*124 1014. In a study titled, “Pomegranate Ellagitannin-Derived Metabolites Inhibit Prostate Cancer Growth

and Localize to the Mouse Prostate Gland,” Doctors Navindra Seeram, Arie Belledegrum, David Heber,

and colleagues evaluated the effects of pomegranate extract on prostate cancer growth in severe combined

immunodeficient mice injected with human prostate cancer cells. The study showed that pomegranate extract

significantly inhibited prostate cancer in the mice as compared to the control. Researchers also found that ellagic

acid and synthesized urolithins from the pomegranate extract were shown to inhibit the growth of human prostate

cancer cells in vitro. The researchers concluded that the chemopreventive potential of pomegranate ellagitannins

and localization of their bioactive metabolites in mouse prostate tissue suggest that the pomegranate may play a

role in prostate cancer treatment and chemoprevention. The researchers also stated “[t]his warrants future human

tissue bioavailability studies and further clinical studies in men with CaP [prostate cancer].” (PX0069).

1015. In a study titled, “Pomegranate polyphenols down-regulate expression of androgensynthesizing genes in

human prostate cancer cells overexpressing the androgen receptor,” Doctors Hong, Seeram, and Heber examined

the effects of pomegranate polyphenols from POMx Pills and POM Wonderful 100% pomegranate juice on the

expression of androgen enzymes and androgen receptors. The study stated: recurrent prostate tumors advance to

an androgen-independent state where they progress in the absence of circulating testosterone, leading to advanced

cancer. The study also stated: during the development of the androgen-independent state, prostate cells are known

to increase intracellular testosterone synthesis, which maintains cancer cell growth in the absence of significant

amounts of circulating testosterone and that over-expression of androgen receptor to produce testosterone occurs

in androgen-independent prostate cancer. The study found that POM polyphenols from either POMx Pills or

POM Wonderful 100% pomegranate juice significantly inhibited gene expression and androgen receptors as a

potential mechanism for maintaining healthy prostate cells. The researchers concluded that, “these results suggest

that pomegranate polyphenols may be particularly helpful in the subgroup of patients with androgen-independent

prostate cancer.” (PX0068).

1016. A study by Doctors Rettig, Heber, et al., titled, “Pomegranate extract inhibits androgen-independent

prostate cancer growth through a nuclear factor-kappaB-dependent mechanism,” evaluated POMx Pills and POM

Wonderful 100% pomegranate juice and found that their consumption was linked to reduction in cancer growth

and decreased plasma PSA levels. The study found that one of the most well-established signaling pathways

mediating inflammatory responses relevant to cancer is the NF-kB pathway, which serves as a predictor for

recurrence of prostate cancer after radical prostatectomy, and that POMx inhibited NF-kB and cancer cell viability

in a dose response fashion in vitro and Human LAPC4 prostate cancer xenograft mouse model. Based on the

results reported, the researchers concluded “that pomegranate juice could have potential as a dietary agent to

prevent the emergence of androgen-independence,” thus potentially prolonging life expectancy of prostate cancer

patients, and suggested “that this may be a high priority area for future clinical investigation.” (PX0070).

*125 1017. In a study by Dr. Sartippour, et al., titled, “Ellagitannin-Rich Pomegranate Extract Inhibits

Angiogenesis In Prostate Cancer In Vitro And In Vivo,” the in vivo results showed that POMx Pills inhibit prostate

tumor growth compared to control in immunodeficient mice injected with human prostate cancer cells. The mice

were given a dose comparable, using caloric demand scaling, to that found in POMx and taken by humans. The

study reported that POMx was shown to significantly decrease the overall blood vessel density in mouse tumors.

The study also stated that in vitro results showed that POMx Pills significantly inhibited proliferation of human

prostate cancer cells at low ug/ml. concentrations. The researchers concluded, “these findings strongly suggest the

potential of pomegranate ellagitannins for prevention of the multi-focal development of prostate cancer as well

as to prolong survival in the growing population of prostate cancer survivors of primary therapy.” (PX0071).

b. Complaint Counsel's experts' opinions of basic research on prostate cancer
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1018. Complaint Counsel's experts testified that to substantiate a claim that a food or dietary supplement is an

effective treatment for prostate cancer, experts in the field would require an RCT trial with an appropriate sample

population of patients with the stage of the disease targeted by the study, and measuring a proper endpoint.

(CX1287 (Eastham Expert Report at 0015)).

1019. Complaint Counsel's experts reviewed the available in vitro and animal research and concluded that RCTs

with proper endpoints are needed to confirm the potential antioxidant effect on prostate cancer observed in a test

tube or laboratory setting. (CX1293 (Stampfer Expert Report at 0022); CX1287 (Eastham Expert Report at 0021)).

c. Respondents' experts' opinions of basic research on prostate cancer

1020. Dr. deKernion explained that Respondents' animal studies were on human prostate tissue inserted in the

animals and were not merely a study of animal glands. (deKernion, Tr. 3049).

1021. Dr. DeKernion testified that Respondents' in vitro and animal studies showed that pomegranate juice

inhibited the growth of prostate cancer cells and actually killed cancer cells from humans that had been inserted

into mice. (deKernion, Tr. 3044-47, 3120; PX0351 (deKernion, Dep. at 110).

1022. Dr. deKernion testified that while one cannot always extrapolate from in vitro and animal results to what

the results would be in humans, the pre-clinical studies he reviewed indicated a strong likelihood that, in humans,

pomegranate juice would at least inhibit the growth of prostate cancer cells. (deKernion, Tr. 3063-64; PX0161

(deKernion Expert Report at 0011-12)).

1023. Dr. deKernion also testified that that even where the animal and in vitro evidence is strong and shows that

an agent's mechanism of action works, this evidence does not prove that an agent works in humans. (deKernion,

Tr. 3063-64).

d. Determination on Respondents' basic research

*126 1024. Experts in the field agree that even where the animal and in vitro evidence is strong and shows that an

agent's mechanism of action works, this evidence alone does not prove that an agent works in humans. (deKernion,

Tr. 3063-64; Stampfer, Tr. 722-25 (animal studies do not always correspond with what will occur in humans; one

cannot assume that if an in vitro assay shows a certain result, the same result will occur in the human body)).

4. Human clinical studies

1025. Respondents have one human clinical study completed and published, the Pantuck Phase II Cancer Study

(2006), and one ongoing human clinical study, the Carducci Dose Study, according to their January 13, 2009

summary of their prostate cancer research as of that date. (CX1029 at 0004).

a. Pantuck Phase II Prostate Cancer Study

i. Background to the Pantuck Study
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1026. Dr. Allan J. Pantuck is an associate professor of Urology at UCLA Medical School and maintains a clinical

practice at UCLA. He attended college at Columbia University, medical school at Robert Woods Johnson Medical

School, and has a Masters Degree in Clinical Research from UCLA Medical School. (CX1090 at 0001; CX1341

(Pantuck Dep. at 20-21)).

1027. Dr. Pantuck's clinical appointments include: Attending Urologist at Harbor-UCLA Medical Center,

Attending Urologist Wadsworth Veterans Affairs Medical Center, and Attending Urologist, UCLA Medical

Center. (CX1090 at 0004).

1028. Dr. Pantuck's professional societies and memberships include the American Society of Clinical Oncology,

American Urological Association, Jonsson Comprehensive Cancer Center, and the Society of Urologic Oncology.

(CX1090 at 0002).

1029. Dr. Pantuck served as editor of Advances in the Management of Renal Cell Carcinoma and Proceedings

of the Irish Society of Surgical Oncology (2003). Dr. Pantuck has been a reviewer for medical journals such as

the British Journal of Urology International, The Journal of Urology, Clinical Cancer Research, and Urologic

Oncology. (CX1090 at 0003).

1030. In 2001, Dr. Pantuck wrote a letter to Dr. Dornfeld and Dr. Harley Liker (Respondents' scientific advisors)

setting forth his protocol concepts for two clinical studies studying the benefits of pomegranate juice in populations

of men with prostate cancer. (CX0544 at 0001). According to the letter, “these pilot studies are designed to provide

preliminary data to justify further development of pomegranate juice as a chemopreventative agent for prostate

cancer.” (CX0544 at 0001). One of the two proposed protocol concepts became the Phase II Study of Pomegranate

Juice for Men with Rising Prostate-Specific Antigen following Surgery or Radiation for Prostate Cancer (“Pantuck

Study”). (CX1341 (Pantuck, Dep. at 57)).

1031. The Pantuck Study began in 2003. (CX1128 at 0001). According to the protocol, the study was a singlecenter, three-year study in which approximately 40 patients with prostate cancer treated by radical prostatectomy

or radiotherapy with a rising PSA would receive eight ounces of pomegranate juice daily. (CX0666 at 0004-05).

*127 1032. By 2006, the Pantuck Study was complete and ready for publication. Dr. Pantuck first submitted the

manuscript for the study to the Journal of Clinical Oncology. (CX1341 (Pantuck, Dep. at 107)). It was initially

rejected. (CX1341 (Pantuck, Dep. at 107)). He subsequently submitted it to Clinical Cancer Research. (CX1341

(Pantuck, Dep. at 107)). One peer reviewer called the manuscript “excessively advocatory of pomegranate juice

as a treatment for prostate cancer.” (CX0790 at 0001). Dr. Pantuck addressed this concern and other comments

by making various changes to the manuscript. (CX0790; CX0786).

1033. The Pantuck Study, titled, “Phase II Study of Pomegranate Juice for Men with Rising Prostate-Specific

Antigen Following Surgery or Radiation for Prostate Cancer,” Pantuck, et al., was published in the journal Clinical

Cancer Research in July 2006. (CX0815).

1034. Clinical Cancer Research is an extremely well regarded peer-reviewed journal. The process and rigor for

being published in Clinical Cancer Research is very high. It is considered one of, if not the, finest clinical cancer

journals. (CX1352 (Heber Dep. at 268-69).

1035. Dr. Heber testified that the Pantuck Study is considered, “a very highly esteemed paper.” (CX1352 (Heber,

Dep. at 268)).
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1036. The Pantuck Study was the first clinical trial of pomegranate juice in patients with prostate cancer. (CX0815

at 0001).

1037. According to the published study report, the Pantuck Study was “an open-label, single-arm clinical trial,”

meaning it was not an RCT and did not have a placebo group. (CX0815 at 0002).

1038. The Pantuck Study cost $479,236.50. (CX1128 at 0001).

ii. About the Pantuck Study

1039. The Pantuck Study included 46 patients who had been diagnosed with prostate cancer. The majority of

the patients (68%) had been previously treated for prostate cancer by undergoing radical prostatectomy. The

remainder had been treated by radiation (10%), brachytherapy (10%), a combination of surgery and radiation

(7%), or cryotherapy (5%). (CX0815 at 0003).

1040. All 46 patients in the Pantuck Study drank eight ounces of pomegranate juice daily until meeting disease

progression endpoints. Clinical endpoints were effect on serum prostate specific antigen (PSA), serum-induced

proliferation and apoptosis of prostate cancer cells, serum lipid peroxidation, and serum nitric oxide levels. The

primary endpoint was the effect on PSA variables, such as change in prostate specific antigen doubling time

(PSADT). (CX0815 at 0002).

1041. The presence of detectable PSA after radical prostatectomy or other radical treatment usually indicates

cancer is present. (deKernion, Tr. 3051).

1042. PSADT is a mathematical expression of the rapidity with which the prostate specific antigen is rising, and

an expression of the rapidity of growth and number of prostate tumor cells. (deKernion, Tr. 3050).

1043. Patients in the Pantuck Study had their blood drawn every three months to have their PSA determined.

Disease progression was defined as either a greater than 100% increase in PSA (with a minimum value of 1.0 ng/

ml.) compared with the best response observed or any documentation of metastatic or recurrent disease. (CX0815

at 0002).

*128 1044. Patients in the Pantuck Study who consumed POM Juice experienced a significant statistical increase

in PSADT when compared to their own baseline pre-treatment PSADT. (CX0815 at 0001, 0004).

1045. In the Pantuck Study, the average pre-treatment PSADT before intervention was approximately 15 months,

and after 33 months, the average post-treatment PSADT was approximately 54 months. Thus, mean PSA doubling

time significantly increased from a mean of 15 months at baseline to 54 months post-treatment. (CX1080 at 0004).

1046. The Pantuck Study reported: in vitro assays comparing pre-treatment and post-treatment patient serum on

the growth of the prostate cancer line LNCaP showed a 12% decrease in cell proliferation and a 17% increase in

apoptosis, a 23% increase in serum NO, and significant reductions in oxidative state and sensitivity to oxidation

of serum lipids after pomegranate juice consumption versus before pomegranate juice consumption. (CX0815 at

0001).

1047. The Pantuck Study concluded: the statistically significant prolongation of PSA doubling time, coupled with

corresponding laboratory effects on prostate cancer in vitro cell proliferation and apoptosis, as well as oxidative

stress, warrant further testing in a placebo-controlled study. (CX0815 at 0001).
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iii. Follow up to the Pantuck Study

1048. In 2008, Dr. Pantuck released the following abstract: Pantuck, AJ, et al., “Long term follow up of

pomegranate juice for men with prostate cancer and rising PSA shows durable improvement in PSA doubling

times,” American Society of Clinical Oncology (“Pantuck Phase II Follow-Up Results”) which summarized

follow-up results for the Pantuck Study. (PX0061).

1049. The Pantuck Phase II Follow-Up Results reported that fifteen (31%) active patients remained on the study.

(PX0061). All of the men who had dropped out of the study did so because their PSA had increased. (CX0918 at

0001). As of June 2010, only 12 patients remained active in the study. (CX1128 at 0001).

1050. The Pantuck Phase II Follow-Up Results reported that those who continued on pomegranate juice

maintained a lengthening of their PSA doubling time compared to men who did not continue on pomegranate

juice. (PX0061; Eastham, Tr. 1305; CX1341 (Pantuck, Dep. at 136)).

1051. The Pantuck Phase II Follow-Up Results reported: mean PSA doubling time for the entire cohort continued

to show a significant increase following treatment, from a mean of 15.4 at baseline to 60 months post-treatment,

while the median PSA slope decreased 60% from 0.06 to 0.024. Patients remaining on study (“active”) were

compared to those no longer on study (“non-active”). At baseline, mean PSA doubling times were similar between

Active and Non-Active patients. However, post-treatment PSADT prolongation was greater and the decline in

median PSA slope was larger in active compared to non-active patients. (PX0061).

1052. The Pantuck Phase II Follow-Up Results concluded that long-term follow up of pomegranate juice

consumption in men with prostate cancer and rising PSA following primary therapy demonstrates a durable

increase in PSA doubling time and stated that a multi-center, randomized phase III study is ongoing to further

evaluate the benefits of pomegranate in a placebo-controlled manner. (PX0061).

iv. Statements by Dr. Pantuck about the Pantuck Study

*129 1053. Dr. Pantuck explained that the design of the study was for subjects to serve as their own control.

Patients had a specific PSA doubling time prior to treatment; patients would then be treated and measured for any

change in their doubling time after treatment. (CX1341 (Pantuck, Dep. at 78)).

1054. When the Pantuck Study report was released in 2006, Dr. Pantuck was quoted in an American Association

for Cancer Research press release, as stating: “[w]e don't believe we are curing anyone from prostate cancer.”

He pointed out that “although a third of patients experienced a decrease in PSA during the study, nobody's PSA

went to zero.” Dr. Pantuck further explained: “The PSA doubling time, however, was longer. For many men,

this may extend the years after surgery or radiation that they remain recurrence free and their life expectancy is

extended. They may be able to prevent the need to undergo additional therapies, such as radiation, hormonal or

chemotherapies.” (CX0816 at 0002).

1055. Dr. Pantuck stated that the Pantuck Study did not prove that pomegranate juice prevents or reduces the risk

of prostate cancer because all the patients in the study already had prostate cancer, thus his study did not address

anything related to causation. (CX1341 (Pantuck, Dep. at 108)).
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1056. Dr. Pantuck did not claim that the Pantuck Study proved that pomegranate juice can treat prostate cancer, but

explained that the study showed that the doubling time for PSA was prolonged. (CX1341 (Pantuck, Dep. at 108)).

1057. Dr. Pantuck testified that the Pantuck Study showed evidence that the growth of the cancer had been altered

by POM Juice. (CX1341 (Pantuck, Dep. at 118-19)).

1058. Dr. Pantuck stated that the feedback from the scientific community with regard to the peer-reviewed

published Pantuck Study has primarily been favorable, and that some doctors have discussed the findings with

patients. (CX1341 (Pantuck, Dep. at 268-69)).

1059. Dr. Pantuck also stated: “[i]t remains controversial whether modulation of PSA levels represents an equally

valid clinical end point.” (CX0815 at 0008). According to Dr. Pantuck, “PSA has not been validated prospectively

as a surrogate endpoint for a meaningful prostate cancer outcome.” (CX1080 at 0001). Dr. Pantuck has also stated

that “although PSA changes are thought to be prognostically important, it is based on level 2 evidence, and nobody

has ever shown conclusively that changes in PSA kinetics arising from therapeutic intervention is meaningful.”

(CX1080 at 0001).

1060. Dr. Pantuck testified that the greatest limitation of the Pantuck Study was the lack of a blinded control arm.

(CX1341 (Pantuck, Dep. at 110)). In the published study report, Dr. Pantuck specifically pointed to the published

study, Rosiglitizone versus Placebo for Men with Prostate Carcinoma and a Rising Serum Prostate-Specific

Antigen Level after Radical Prostatectomy and/or Radiation Therapy, Cancer 2004: 101:1569-74 (“Rosiglitizone

Study”). (CX0815 at 0008).

*130 1061. The Rosiglitazone Study was a randomized, double-blind placebo-controlled study examining the

effect of rosiglitazone in a population of men similar to the patients studied in the Pantuck Study, namely men

who had been treated by radical prostatectomy or radiation with a rising PSA. (PX0172 at 0001; CX0815 at 0001;

deKernion, Tr. 3069). The Rosiglitazone Study found that 40% of the placebo group and 38% of the treatment

group experienced a prolongation in PSADT. (PX0172 at 0001; deKernion, Tr. 3071).

1062. The Rosiglitizone Study authors stated that “[t]he discordance between baseline and post-treatment PSADT

in our placebo group suggests caution is required when using changes in PSADT as an outcome in uncontrolled

trials and reinforces the value of randomized, placebo-controlled trials in this setting.” The Rosiglitazone Study

authors concluded that, “the current results do not diminish the potential value of changes in PSADT as an outcome

variable for the early evaluation of novel therapeutic agents. In randomized studies of similar design, more active

agents may demonstrate the value of PSA kinetics as a screen for biologic activity.” (PX0172 at 0006).

1063. Dr. Pantuck stated that the Rosiglitazone Study “highlights the potential limitations of PSA variables in

monitoring patients and the need for confirmatory prospective studies using a blinded control arm.” (CX0815 at

0008).

b. Carducci Study

i. Background to the Carducci Study

1064. Respondents have also sponsored a human study looking at POMx use in men who have already been treated

for prostate cancer. The study is completed and an abstract summarizing the results has been published. See M.A.

Carducci, et al., A Phase II Study of Pomegranate Extract for Men with Rising Prostate-Specific Antigen Following

Primary Therapy (“Carducci Study”), J Clin Oncol 29: 2011 (suppl 7; abstr 11). (PX0175; see also CX1174). A
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final, peer-reviewed study report had not been published at the start of trial in this matter. (See Nonparties Johns

Hopkins University and Michael A. Carducci, M.D.'s Motion for In Camera Treatment, at 5).

1065. The Carducci Study was conducted by Dr. Michael A. Carducci, a professor of oncology and urology at the

Johns Hopkins School of Medicine, in Baltimore, Maryland. Within the Cancer Center, he leads two programs,

the prostate cancer/genitourinary cancer program and chemical therapeutics. (CX1340 (Carducci, Dep. at 14-15);

CX1120).

1066. Dr. Carducci is a graduate of Georgetown University and Wayne State University Medical School. Dr.

Carducci did a residency in internal medicine at the University of Colorado in Denver. After completing a year as

chief resident at the University of Colorado, he accepted a fellowship in oncology at Johns Hopkins University.

(CX1340 (Carducci, Dep. at 13-14)).

1067. Dr. Carducci has conducted 40 to 50 clinical trials relating to prostate cancer and has published

approximately 80 articles related to prostate cancer. (CX1340 (Carducci, Dep. at 15-16)).

*131 1068. In 2006, Dr. Carducci began working with Respondents to design the Carducci Study. (CX0806).

Dr. Carducci submitted a proposed protocol for the Carducci Study to Respondents for a larger randomized threearm study, with two treatment arms and one placebo arm. (CX1340 (Carducci, Dep. at 28-29; CX0064 at 0002,

in camera).

1069. Respondents conducted a feasibility and cost analysis and decided that the study proposed by Dr. Carducci

was too costly. The placebo arm was dropped from the study due to costs, and, in part, due to poor patient

acceptance of a placebo. (CX1340 (Carducci, Dep. at 28-29)).

ii. About the Carducci Study

1070. The Carducci Study began in January 2008. (CX1138 at 0002). According to the protocol, the Carducci

Study was an 18-month, multi-center, randomized, double-blind, dose-finding study of the effect of two different

doses of POMx capsules (one or three capsules) on PSADT in men who had received initial therapy for prostate

cancer. (CX1110 at 0007).

1071. An interim analysis of the Carducci Study was conducted in 2009 and shared with Respondents in 2010.

(See CX1088, in camera; CX1102, in camera). The final analysis was conducted in August 2010. (CX1146, in

camera).

1072. In 2011, Dr. Michael Carducci presented the abstract of his clinical research study titled, “A Phase II Study

of Pomegranate Extract for Men with Rising Prostate-specific Antigen Following Primary Therapy” at the disease

specific meeting of the American Society of Clinical Oncology (“Carducci abstract”). (PX0175). Dr. Carducci's

abstract was peer-reviewed prior to being selected for presentation. (CX1340 (Carducci, Dep. at 176)).

1073. The Carducci Study was a multi-center, double blind Phase II randomized trial that studied 104 men with

rising PSA and without metastases. They were given either a high or low dose (one capsule or three capsules)

of POMx, stratified by baseline PSADT and Gleason score, and with no restrictions for PSADT and no upper

limit PSA value. (PX0175).

1074. In the Carducci Study, men were treated until progression or for 18 months. PSA levels were obtained every

three months. (PX0175).
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iii. Results of the Carducci Study

1075. According to the Carducci abstract, 104 men were enrolled and treated for up to six months (92%), 12

months (70%), and 18 months (36%). There was no significant treatment difference (p = .920) in PSADT between

the one capsule and three capsule dose groups. (CX1174 at 0001).

1076. The Carducci abstract reported: median PSADT lengthened from 11.9 months at baseline to 18.5 months

after treatment (p < .001), a within group measurement. Thus, it showed that POMx treatment significantly

increased the PSA doubling time by over six months in both treatment arms. (CX1174 at 0001).

1077. The Carducci abstract also reported that 13 patients (13%) had declining PSA levels during the study.

(CX1174 at 0001).

1078. The Carducci abstract concluded that POMx demonstrates “promising antitumor effects in prostate

cancer.” (CX1174 at 0001).

iv. Statements by Dr. Carducci about the Carducci Study

*132 1079. Dr. Carducci testified that the use of PSA doubling time as a primary endpoint to determine if POMx

has an effect on the disease state was a scientifically valid way to conduct the study. (CX1340 (Carducci, Dep.

at 181-82)).

1080. Dr. Carducci also testified that the endpoint of PSA doubling time is not a standard for regulatory approval of

drugs at the FDA level and PSA doubling time as a marker or surrogate has not been proven. (CX1340 (Carducci,

Dep. at 89-90)).

1081. Dr. Carducci stated that the Carducci Study was not designed to use endpoints that were “drug-like,” but

was specifically designed for a natural product and that researchers were looking at safety and whether POMx

had an effect on rising PSA. (CX1340 (Carducci, Dep. at 50-51)).

1082. Dr. Carducci testified that the Carducci Study results, as designed and planned, were statistically significant.

(CX1340 (Carducci, Dep. at 183)).

1083. Dr. Carducci also testified that without a placebo, he cannot be sure that the effect on PSADT observed in

the Carducci Study is attributable to POMx. (CX1340 (Carducci, Dep. at 95)).

1084. According to Dr. Carducci, the Carducci Study was never designed to prove, and did not prove, that POMx

prevents or reduces the risk of prostate cancer. (CX1340 (Carducci, Dep. at 87-88)).

1085. According to Dr. Carducci, the Carducci Study was never designed to prove that POMx treats prostate

cancer but the study showed that PSA doubling time increased by over six months in both arms of the study.

(CX1340 (Carducci, Dep. at 87).

c. Expert opinion on the human clinical studies
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i. Complaint Counsel's experts on the Pantuck Study

1086. Complaint Counsel's experts testified that the Pantuck Study fails to provide support for prostate cancer

treatment claims for two major reasons: the lack of a placebo control group and the lack of an accepted endpoint

marker. (Eastham, Tr. 1295-97; CX1287 (Eastham Expert Report at 0018-19); CX1293 (Stampfer Expert Report

at 0024-25); Stampfer, Tr. 782-83).

1087. According to Dr. Stampfer, without a placebo control group in the Pantuck Study, it is not possible to know

whether the same change in PSADT would have been observed in this patient group if they had never received

POM Juice. (Stampfer, Tr. 869-70; CX1293 (Stampfer Expert Report at 0024)).

1088. According to Dr. Eastham, if the Pantuck Study had included a control group, it is possible that no statistical

difference between groups would have been observed. Without a placebo, there is no way to eliminate confounding

factors that may have impacted PSADT — such as changes in diet, exercise, or the reduction of stress. (Eastham,

Tr. 1295-97; CX1287 (Eastham Expert Report at 0018)).

1089. The Pantuck Study used mean PSA doubling time as an endpoint. (PX0060). Complaint Counsel's experts

testified that in a prostate cancer treatment trial, PSA doubling time is not a relevant surrogate marker for prostate

cancer prevention. Instead, in a prostate cancer treatment trial, overall survival or prostate cancer-specific mortality

is the endpoint generally accepted by experts in the field. (CX1293 (Stampfer Expert Report at 0025); Eastham, Tr.

1280; CX1287 (Eastham Expert Report at 0006-09, 0014) (“The primary endpoint in a prostate cancer prevention

trial for measuring whether a product has been effective is the prevalence or incidence of prostate cancer between

the treatment and placebo groups at the conclusion of the study.”).

*133 1090. Dr. Eastham criticized the Pantuck Study for the additional reason that the patients studied, with an

average pre-treatment PSADT of 15 months, are considered to have a far lower risk of clinical progression, and

because of this, it is unclear whether the increase in PSADT observed in the Pantuck Study is clinically significant.

(Eastham, Tr. 1297-98).

1091. Complaint Counsel's experts also testified that the Pantuck Study was designed as a treatment study (i.e.,

study was conducted in men with prostate cancer) and does not provide any evidence that POM Juice is a prostate

cancer preventative. (CX1293 (Stampfer Expert Report at 0025); Eastham, Tr. 1294-99).

1092. Dr. Eastham opined that the appropriate sample population for a cancer prevention trial “would involve

more than 10,000 healthy men, ages 50 to 65, having no sign of prostate cancer.” (CX1287 (Eastham Expert

Report at 0012)).

1093. Dr. Eastham further opined that a “prostate cancer prevention study must be conducted over a long enough

period of time to see an effect over time.” CX1287 (Eastham Expert Report at 0014)).

1094. Complaint Counsel's experts also state that the Pantuck Study on POM Juice cannot provide reliable

evidence to support claims about POMx Pills' or POMx Liquid's benefit for prostate cancer. (Eastham, Tr. 1306;

CX1293 (Stampfer Expert Report at 0025); CX1287 (Eastham Expert Report at 0020)). According to Dr. Eastham,

POM Juice is not identical to POMx Pills and POMx Liquid. (CX1287 (Eastham Expert Report at 0020)). POM

Juice has more than one active ingredient. Processing may result in eliminating a needed ingredient. (Eastham, Tr.

1306-07). Even if the active ingredient is known and the alternate compound contains the same amount of active

ingredient, the alternate compound may contain some other as yet unknown compound that might counter-act the

benefit of the active agent. (CX1287 (Eastham Expert Report at 0020)).
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1095. Dr. Eastham is not an expert in bioavailability and did not review any of the equivalency studies or articles

on POM Juice, POMx Pills or POMx Liquid. (PX0358 (Eastham, Dep. at 94)).

ii. Complaint Counsel's experts on the Carducci Study

1096. Complaint Counsel's experts testified that the Carducci Study cannot provide support for treatment claims

because it lacked a placebo-control group and that without a placebo-control group, it is not possible to conclude

that POMx caused the change in the patients' PSADT. (Eastham, Tr. 1310; CX1287 (Eastham Expert Report at

0022); Stampfer, Tr. 789-90; CX1293 (Stampfer Expert Report at 0028)).

1097. Complaint Counsel's experts testified also that the Carducci Study cannot provide support for treatment

claims because the primary endpoint in the study is PSADT, which has not been accepted by experts in the field as

a surrogate for overall survival. (Eastham, Tr. 1310; CX1287 (Eastham Expert Report at 0022); CX1293 (Stampfer

Expert Report at 0028)).

1098. As found in F. 1075, the Carducci Study showed no difference between a one pill dose and a three pill dose.

Complaint Counsel's expert testified that the lack of a dose response despite a three-fold difference in dosage

does not support a causal relationship between POMx and change in PSADT. (Stampfer, Tr. 789-90; CX1293

(Stampfer Expert Report at 0028)).

*134 1099. Complaint Counsel's experts also testified that the Carducci Study cannot provide support for

prevention claims because it evaluated the effect of POMx in men who already had prostate cancer. (Eastham, Tr.

1309-10; see also CX1293 (Stampfer Expert Report at 27)).

iii. Complaint Counsel's experts on PSA doubling time

1100. Complaint Counsel's experts testified that in a prostate cancer treatment trial, PSA doubling time is not a

relevant surrogate marker for prostate cancer prevention. (Eastham, Tr. 1280; CX1287 (Eastham Expert Report

at 0006-09); CX1293 (Stampfer Expert Report at 0025)).

1101. In his testimony, Dr. Eastham stated: modulation of PSA doubling times has not been proven to be of any

utility and that no one would propose that changes or modulation of PSA doubling time is a prognostic factor in

men with biochemical recurrence after primary therapy for prostate cancer. (Eastham, Tr. 1342, 1345).

1102. Dr. Eastham has also written, in an article titled, “Prostate-specific antigen doubling time as a prognostic

marker in prostate cancer,” Nature Clinical Practice (2005): “PSA doubling time has emerged as an important

factor in the evaluation of men with newly diagnosed prostate cancer or prostate cancer that recurs after treatment.

PSA doubling time can also be used as a surrogate marker for prostate cancer-specific death.” Dr. Eastham's article

concluded “PSADT is an important prognostic marker in men with biochemical failure after local therapy for

prostate cancer, and it predicts the probable response to salvage radiotherapy, progression to metastatic disease

and prostate cancer specific death.” (PX0178 at 0001, 0009).

1103. In his expert report, Dr. Stampfer opined “it is unknown if PSADT predicts overall survival in prostate

cancer patients throughout its range.” (CX1293 (Stampfer Expert Report at 0026)).

1104. Dr. Stampfer also testified that PSA doubling time is a “predictor of disease and mortality” and that, if the

extension of PSA doubling time is true, it would substantially prolong lives. (Stampfer, Tr. 869, 873).
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iv. Respondents' experts on both clinical studies

(a) PSA doubling time

1105. Dr. deKernion testified that the presence of detectable PSA after radical prostatectomy or other radical

treatment usually indicates cancer is present and that PSADT provides an expression of how those tumor cells are

going to behave. The longer the PSADT, the less dangerous the growth of the cancer. (deKernion, Tr. 3051-52).

1106. Dr. deKernion testified that the Pantuck Study and the Carducci Study showed that POM Juice and POMx,

respectively, slowed down the growth of the tumor cells as expressed by the longer time it took for those tumor

cells to double. (deKernion, Tr. 3057).

1107. Dr. deKernion testified that the Pantuck Study and the Carducci Study both showed a dramatic lengthening

of PSA doubling time. (deKernion, Tr. 3052-58).

1108. Dr. deKernion opined that PSA doubling time is used to determine success or failure of prostate cancer

treatment and that multiple studies support that PSADT is correlated with the risk of clinical tumor and recurrence

and, therefore, must have some association with longevity. (PX0161 (deKernion Expert Report-0004; deKernion,

Tr. 3050-58).

*135 1109. Dr. deKernion stated that PSA doubling time is clearly a useful marker in determining risk or outcome

in patients following prostate cancer treatment. (deKernion, Tr. 3055).

1110. Dr. deKernion testified that given the understanding of PSA doubling time in predicting risk of clinical

recurrence and to some extent survival, it is logical to use changes in PSADT as indicative of an intervention's

effectiveness regarding prostate tumor behavior. (PX0161 (deKernion Expert Report at 0007, 0011-12)).

1111. Dr. deKernion also testified that the PSA doubling time is not accepted by experts in the field of prostate

cancer as a surrogate endpoint for clinical benefit in chemotherapy trials. (deKernion, Tr. 3096).

1112. Dr. Heber testified that PSA doubling time is a “very important clinically utilized marker of clinical

status.” (CX1352 (Heber, Dep. at 314)).

1113. Dr. Heber testified that there is a lot of support from the urological community to get the FDA to accept

PSA doubling time as a surrogate endpoint and that there is “a lot of feeling in the urological community and

scientific agreement that [the] rate of rise of PSA is an important biomarker.” (CX1352 (Heber, Dep. at 316-17)).

(b) Placebo control arm

1114. Dr. deKernion testified that a control arm is not necessary for an objective Phase II study that is exploratory

in nature. Many studies on food and many other categories in science are observational type studies without use of

a control—a control is important when there is a high risk that the observed effect could be attributed to something

other than the substance being tested. (PX0161 (deKernion Expert Report at 0009); deKernion, Tr. 3059-60, 3066;

PX0351 (deKernion, Dep. at 97-99)).
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1115. Dr. deKernion testified that in both the Pantuck Study and the Carducci Study, the control was the previous

doubling time prior to treatment. The researchers measured the doubling time before patients took POM Juice

or POMx and then measured doubling time afterwards, comparing one to the other. This was done in lieu of a

separate placebo group. (deKernion, Tr. 3059).

1116. Dr. deKernion testified that a control arm is often used to control for the placebo effect, that one purpose

of a placebo control group is to limit confounding factors, and that the use of a placebo group is more important

when you have a subjective reporting, as opposed to an objective reporting. (deKernion, Tr. 3059-60, 3066-67;

PX0351 (deKernion, Dep. at 97-99)).

1117. Dr. deKernion specifically testified that a placebo control arm is not needed when PSADT is the study

endpoint to assess the efficacy of the product or therapy being studied. In the Pantuck Study and the Carducci

Study, the researchers were looking and testing objective blood results, and there is no evidence to suggest the

placebo effect plays any role in modulating the PSADT of the subject. (deKernion, Tr. 3059-60, 3081; PX0351

(deKernion, Dep. at 97-99).

*136 1118. Dr. deKernion also testified that without a placebo, one cannot be certain that the effect on PSA

doubling time seen in the Carducci Study is attributable to POMx. (deKernion, Tr. 3103).

(c) Respondents' experts' conclusions

1119. Dr. Heber testified that in laboratory studies he conducted, he found no difference in the antioxidant effect

between POM Juice and POMx products and that animal studies indicate that the effects of pomegranate juice

and POMx Pills on prostate cancer are equivalent. (CX1352 (Heber, Dep. at 336); Heber, Tr. 2002; Heber, Tr.

2186-87).

1120. At trial, Dr. Heber testified that there is competent and reliable science showing that the POM Juice and

POMx lengthen the PSA doubling time for men who have had prostate cancer and, thus, it is likely for those men

to have a deferred recurrence or death from that disease; and that POM Juice and POMx are likely to lower the

risk of prostate problems for men who have not yet been diagnosed with prostate cancer. (Heber, Tr. 2012-13).

1121. In his expert report, Dr. Heber opined: the statistically significant prolongation of PSA doubling time,

corresponding laboratory effects on prostate cancer in vitro cell proliferation and apoptosis, as well as oxidative

stress and inflammation, provide strong scientific rationale for the statement that pomegranate juice promotes

prostate health. (PX0192 (Heber Expert Report at 0027)).

1122. Dr. deKernion testified that in order to show an effect of POM Products on prostate cancer, the best way to

do that research is on patients whose prostate had been removed because the presence of PSA elevation is almost

always an indication of remaining cancer. This is how the Pantuck Study and Carducci Study were conducted.

(deKernion, Tr. 3057).

1123. Dr. deKernion opined that all “evidence supports that PSA changes including doubling time after failure of

definitive therapy truly reflect a change in the tumor cell growth; no evidence exists to suggest that a biochemical

effect on PSA measurement can account for changes; and no evidence exists that PSA doubling time significantly

and spontaneously lengthens in a patient with known biochemical or clinical cancer.” (PX0161 (deKernion Expert

Report at 0008)). Therefore, in the Pantuck Study, it is only logical to conclude that the agent causing the change in

PSA doubling time is POM Juice, especially given the pre-clinical evidence of the effect of the POM Products on
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prostate cancer, “and the results of these studies could not be explained otherwise.” (PX0161 (deKernion Expert

Report at 0011-12)).

1124. Dr. deKernion opined that POM Products are beneficial to prostate health and although there is not 100%

proof that POM Products reduce the risk of prostate cancer, the same mechanism shown in the in vitro and animal

studies and in the Pantuck and Carducci human studies showed, with a “high degree of probability,” that POM

Juice and POMx would inhibit the clinical development of prostate cancer in men who have not been diagnosed

with that disease. (deKernion, Tr. 3119-20, 3126; PX0351 (deKernion, Dep. at 41-42)).

*137 1125. Dr. deKernion testified that there is a high degree of probability that POM Products inhibit the

clinical development of prostate cancer cells even in men not diagnosed with prostate cancer. (deKernion, Tr.

3126; PX0351 (deKernion, Dep. at 76-77) (in healthy men, who have never been diagnosed with prostate cancer,

POM Juice and POMx could possibly play a role in preventing them from getting prostate cancer).

1126. Dr. deKernion testified that there is a high probability that the POM Products provide a special benefit to

men with PSA after radical prostatectomy. (deKernion, Tr. 3126).

1127. Dr. deKernion also testified that the Carducci Study did not follow patients for a long enough time, especially

for those with a long PSA doubling time, to prove that POMx will prolong their lives. (deKernion, Tr. 3103).

5. Determinations on the human clinical studies

a. PSA doubling time

1128. Clinicians use PSADT as a prognostic tool at the time of biochemical recurrence of prostate cancer to predict

the odds of clinical progression of the disease in prostate cancer patients who have undergone initial treatment.

(Eastham, Tr. 1260; PX0351 (deKernion, Dep. at 93)). See also PX0178 at 001 (Complaint Counsel's expert

writing: “PSA doubling time has emerged as an important factor in the evaluation of men with newly diagnosed

prostate cancer or prostate cancer that recurs after treatment. PSA doubling time can also be used as a surrogate

marker for prostate cancer-specific death.”).

1129. Clinicians accept PSADT as a useful marker in determining risk or outcome in patients following prostate

cancer treatment and measuring the likelihood of recurrence of the tumor after a man has had his prostate removed.

(deKernion, Tr. 3051, 3055); see also CX1341 (Pantuck Dep. at 254-55) (clinicians find PSADT to be clinically

important for prostate cancer treatment and one of the most important variables that a doctor can discuss to

characterize a prostate cancer patient).

1130. Some published studies demonstrate acceptance of PSA doubling time as a valid predictor of disease:

• In a study titled, “Does PSADT After Radical Prostatectomy Correlate With Overall Survival?” in the January

2011 edition of the Journal of Urology, Dr. Anna Teeter and her colleagues wrote of the “widespread acceptance”

that PSADT after radical prostatectomy predicts prostate cancer mortality; that this has been “well established”;

that PSADT is a “useful tool for identifying men at increased risk of all-cause mortality early in their disease

course”; and that PSADT is “a powerful predictor of overall survival.” (PX0167).

• In a study titled, “Stratification of Patient Risk Based on Prostate-Specific Antigen Doubling Time after Radical

Retropublic Prostatectomy” in the April 2007 issue of Mayo Clinic Proceedings, Dr. Tollefson and colleagues

wrote that PSADT was “a highly significant and reliable test” to determine the likelihood of disease recurrence and

death, an “excellent indicator of clinical disease recurrence” and the only significant factor that predicts clinical
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progression.” The researchers concluded that, “prostate-specific antigen doubling time is an independent predictor

of clinical disease recurrence and mortality after surgical biochemical failure.” (PX0166).

*138 • In a study titled, “Risk of Prostate Cancer-Specific Mortality Following Biochemical Recurrence

After Radical Prostatectomy,” Dr. Freedland and colleagues used PSADT to “define risk factors for prostate

cancer death following radical prostatectomy and to develop tables to risk stratify for prostate cancer-specific

survival.” The researchers found that clinical parameters such as PSADT can help risk stratify patients for prostate

cancerspecific mortality following biochemical recurrence after radical prostatectomy. (PX0165).

• In a study titled, “Recurrence Patterns After Radical Retropubic Prostatectomy: Clinical Usefulness of Prostate

Specific Antigen Doubling Times and Log Slope Prostate Specific Antigen” published in the October 1997 edition

of the Journal of Urology, Drs. Patel, deKernion, et al., studied the correlation between prostate specific antigen

doubling time and clinical recurrence in patients with detectable PSA after radical retropubic prostatectomy

and concluded that, after PSA became detectable, PSA doubling time was a better indicator of the risk and

time to clinical recurrence after radical retropubic prostatectomy than other factors including preoperative PSA.

(PX0162).

1131. There are no studies proving that modulating PSADT (i.e., changing the rate of the PSA doubling time)

changes the natural history of prostate cancer by delaying the development of metastases or death from the disease.

(Eastham, Tr. 1261; CX1287 (Eastham Expert Report at 0011, 0019); PX0161 (deKernion Expert Report at 0004);

PX0351 (deKernion, Dep. at 52-53)).

1132. The FDA has not accepted PSADT as a surrogate endpoint for clinical benefit in chemotherapy trials.

(deKernion, Tr. 3096; CX1352 (Heber, Dep. at 316-17); CX1340 (Carducci, Dep. at 89-90)).

1133. Respondents acknowledged in a report on their expert panel on prostate cancer: “To date, all POM

Wonderful clinical evaluations of pomegranate-derived products in prostate cancer have used PSADT as the

primary endpoint. While data obtained using this approach has generated a high degree of interest from patients

and urologists, it is unclear whether PSADT is acceptable as a registrational endpoint for a drug designed to

prolong the time to disease progression after initial therapy for prostate cancer.” (CX1104 at 0004).

1134. Experts in the field of prostate cancer agree that PSADT is not an accepted surrogate endpoint for survival

or prostate cancer-specific mortality in prostate cancer treatment clinical trials. (Eastham, Tr. 1297; Stampfer,

Tr. 782-83; deKernion, Tr. 3096; CX1287 (Eastham Expert Report at 0010); CX1293 (Stampfer Expert Report

at 0025); CX1340 (Carducci, Dep. at 88-90); CX1341 (Pantuck, Dep. at 253-54)). Many men with increases in

PSA after initial therapy do not die of prostate cancer. On the other hand, some men succumb to prostate cancer

without an increase in PSA. (Stampfer, Tr. 783; Eastham, Tr. 1258; deKernion, Tr. 3088).

b. Research results

*139 1135. There is no clinical study, research or trial that provides 100% proof that the POM Products prevent

prostate cancer in humans. (deKernion, Tr. 3062, 3119).

1136. There is no clinical study, research or trial that provides 100% proof that the POM Products reduce the risk

of prostate cancer in humans. (deKernion, Tr. 3062-63, 3119).
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1137. There is clinical research demonstrating that patients who were given POM Products had their PSA go

down, which is significant evidence that something is happening to those tumor cells. (deKernion, Tr. 3065).

1138. Although one cannot make a firm claim that the POM Products are absolutely preventative, given the data

presented in the Pantuck Study and the Carducci Study, it is reasonable to state that POM Products have shown

an effect on prostate cancer with little or minimal toxicity. (PX0161 (deKernion Expert Report at 0011)).

6. Conclusions

1139. Pomegranate consumption can potentially be used to prevent or delay clinical recurrence of prostate cancer

once a patient experiences biochemical recurrences (PSA recurrences) after a radical prostatectomy. (PX0192

(Heber Expert Report at 0027)).

1140. No Phase III randomized trial has been completed to prove that POM Products prolong the life of patients

who have recurrence of prostate cancer after supposedly curative therapy. Effective trials are ongoing. As reflected

by changes in PSA doubling time, the POM Products are a reasonable adjunct for a patient who wishes to help

their general health and possibly avoid a clinical recurrence of prostate cancer. (See PX0161 (deKernion Expert

Report at 0011)).

1141. The statistically significant prolongation of PSA doubling time, coupled with corresponding laboratory

effects on prostate cancer in vitro cell proliferation and apoptosis as well as oxidative stress, and inflammation

provides strong scientific rationale for the statement that pomegranate juice promotes prostate health and has led

to ongoing phase III clinical trials. (PX0192 (Heber Expert Report at 0027)).

1142. Competent and reliable scientific evidence supports the conclusion that the POM Products support prostate

health, including by prolonging PSA doubling time in men with rising PSA after primary treatment for prostate

cancer. (PX0161 (deKernion Expert Report); (PX0192 (Heber Expert Report at 0027); deKernion, Tr. 3126;

PX0351 (deKernion, Dep. at 41-42); Heber, Tr. 2012).

1143. There is insufficient competent and reliable scientific evidence to support the conclusion that the POM

Products treat, prevent, or reduce the risk of prostate cancer or that clinical studies, research and/or trials

establish these effects. (CX1287 (Eastham Expert Report at 0024-26); Stampfer, Tr. 790-91; CX1293 (Stampfer

Expert Report at 0029-30); see also Eastham, Tr. 1317-19)); see also deKernion, Tr. 3062-63; see also PX0161

(deKernion Expert Report at 0011)).

I. Substantiation for Respondents' Erectile Dysfunction Claims

1. Substantiation standard for erectile dysfunction claims

*140 1144. Clinical evidence supported by basic scientific evidence is sufficient to support claims that

pomegranate juice has a potential benefit for vascular blood flow and the vascular health of the penis. (PX0149

(Burnett Expert Report at 0006)).

1145. Experts in the field of erectile dysfunction would not require RCTs to substantiate health benefit claims for

harmless pure fruit products like pomegranate juice. (PX0149 (Burnett Expert Report at 0006-07); Burnett, Tr.

2272, 2303; PX0189 (Goldstein Expert Report at 0003); Goldstein, Tr. 2600-02, 2611, 2620).
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1146. Experts in the field of erectile dysfunction would not require that pomegranate juice or its derivatives be

subjected to RCTs before concluding that pomegranate juice has a beneficial effect on preserving erectile function.

(PX0149 (Burnett Expert Report at 0006-07); Burnett, Tr. 2272-74, 2303; PX0189 (Goldstein Expert Report at

0003); Goldstein, Tr. 2600-02, 2611, 2620).

1147. Experts in the field of erectile dysfunction would not require that pomegranate juice or derivatives

be subjected to RCTs before concluding that pomegranate juice has a potential beneficial effect on erectile

dysfunction. (Burnett, Tr. 2272-74, 2303).

1148. Experts in the field of erectile dysfunction would require that a product be scientifically evaluated through

rigorous scientific and clinical studies, and believe that animal and in vitro studies alone are not sufficient, before

concluding that pomegranate juice treats erectile dysfunction in a clinical sense. (Burnett, Tr. 2261-64; 2285-86;

2303).

2. Background facts on erectile health and dysfunction

a. Erectile health distinguished from erectile dysfunction

1149. Erectile health is having a healthy erectile mechanism. (PX0189 (Goldstein Expert Report at 0008)).

1150. Erectile health is promoted when the male practices strategies that encourage endothelial health, such as

exercise, use of the Mediterranean diet, and use of endothelial-healthy medications (such as aspirin, statins, and

PDE5-inhibitors). (PX0189 (Goldstein Expert Report at 0008); PX0190; PX0352 (Goldstein, Dep. at 148)).

1151. Erectile health is distinguished from erectile dysfunction. (PX0189 (Goldstein Expert Report at 0008)).

1152. Erectile dysfunction is the consistent or persistent inability to obtain and/or sustain an erection adequate for

sexual intercourse. (Burnett, Tr. 2257; PX0189 (Goldstein Expert Report (Goldstein Expert Report at 0008-09)).

1153. Improving ones erectile function may also help improving ones erectile dysfunction. (Burnett, Tr. 2303).

1154. A clinical treatment for erectile dysfunction is different than the concept of something having a potential

beneficial effect on erectile tissue function and health. (PX0349 (Burnett, Dep. at 56-57)).

1155. Erectile dysfunction has been estimated to affect up to 30 million men in the United States. (PX0189

(Goldstein Expert Report at 0008-09)).

1156. The most common cause of erectile dysfunction is cardiovascular disease. (PX0189 (Goldstein Expert

Report at 0009)).

*141 1157. “Subjects with ED seem to have a vascular mechanism similar to that seen in atherosclerosis [ ... ]

and therefore, a diagnosis of ED may be seen as a sentinel event that should prompt investigation for coronary

heart disease (CHD) in asymptomatic men.” (PX0190 at 0002).

1158. Cardiovascular disease is strongly associated with endothelial cell dysfunction. (PX0189 (Goldstein Expert

Report at 0009)).
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1159. Endothelial cell dysfunction may act to adversely affect the structure and function of the critical arterial

inflow mechanism, the critical expandability of the erectile tissue and the critical integrity of the veno-occlusive

mechanism. (PX0189 (Goldstein Expert Report at 0009)).

1160. The erectile mechanism is largely dependent on the health, integrity, structure and function of the arterial

vascular and corporal erectile tissue systems. (PX0189 (Goldstein Expert Report at 0008)).

b. Physiology of human penile erection

1161. The penis consists of two corpora cavernosa or erectile chambers and a corpus spongiosum or erectile tissue

surrounding the urethra. The corpora cavernosa erectile tissue are contained by a thick and strong fibrous lining

called the tunica albuginea that stretches to some extent during penile erection but also acts as a container to

provide axial rigidity to the erect penis. (PX0189 (Goldstein Expert Report at 0006); Burnett, Tr. 2245).

1162. The erectile tissue includes numerous interconnecting lacunar spaces that fill with blood during erection,

and are lined by vascular endothelial cells. The lacunar spaces are surrounded by vascular smooth muscle and

connective tissue such as collagen and elastin. (PX0189 (Goldstein Expert Report at 0006)).

1163. Arterial blood enters the corpora cavernosa via the right and left cavernosal arteries. There are numerous

small regulatory arteries off the cavernosal artery called helicine arterioles that open into the lacunar spaces. At

the peripheral edge of the erectile tissue, underneath the tunica albuginea, there are small veins called sub-tunical

venules that drain blood from the peripheral lacunar spaces through the tunica into draining veins at the side of

the penis to eventually return blood back to the heart. (PX0189 (Goldstein Expert Report at 0006); Burnett, Tr.

2245-46).

1164. In the flaccid state, smooth muscle in the helicine arterioles and surrounding the lacunar spaces are

contracted allowing only small amounts of blood to enter the erectile chambers. Relaxation of the vascular smooth

muscle of the corpora cavernosa leads to penile erection. Dilation of the helicine arterioles increases perfusion

of high pressure arterial blood into the lacunar spaces. Relaxation of the smooth muscle surrounding the lacunar

spaces results in engorgement of the erectile tissue and expansion of the erectile tissue against the tunca albuginea.

This erectile tissue expansion results in compression of the sub-tunical venules that restricts blood outflow from

the corporal erectile chambers. This venous trapping mechanism is the corporal veno-occlusive mechanism. Due

to the hydraulic nature of increasing blood inflow and perfusion pressure and restricting blood outflow, there

is an increase in intracavernosal pressure to a value approximating the mean systemic arterial blood pressure.

The containment of pressure within the tunica albuginea leads to axial rigidity and penile hardness that enables

functional penile penetration. (PX0189 (Goldstein Expert Report at 0006-07); Burnett, Tr. 2246-48).

c. The role of nitric oxide in human penile erection

*142 1165. Nitric oxide (“NO”) has a beneficial effect on blood flow. (Heber, Tr. 1969, 2140; Burnett, Tr. 2250).

1166. Blood vessels and the flow of blood to the penis are important to erectile function. (Melman, Tr. 1169).

1167. While many types of molecules participate in the erection process, NO “is the key molecule that

governs penile erection,” and is “known to be of paramount importance in the maintenance of good erectile

function.” (PX0149 (Burnett Expert Report at 0004); Burnett, Tr. 2249-50, 2276; PX0190 at 0006). Complaint

Counsel's erectile dysfunction expert, Dr. Melman, agreed that NO employs a critical role in the erectile process
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and that there are men whose erectile dysfunction is caused by the inadequate production of NO. (Melman, Tr.

1169; PX0360 (Melman, Dep. at 32)).

1168. The physiologic mechanism of penile erection involves release of NO in the corpus cavernsosum during

sexual stimulation. (PX0149 (Burnett Expert Report at 0004-05); PX0189 (Goldstein Expert Report at 0007)).

1169. The NO is released from shear stress off the endothelial cells in the lacunar spaces within the corpora

cavernosa and from autonomic nerves that innervate the erectile tissue and are activated during sexual stimulation.

(PX0189 (Goldstein Expert Report at 0007); Burnett, Tr. 2248-49; PX0349 (Burnett, Dep. at 88-90)).

1170. Upon its synthesis and release from their cellular sources, NO diffuses to neighboring vascular and trabecular

smooth muscle cells lining the lacunar spaces. (PX0149 (Burnett Expert Report at 0004-05); PX0189 (Goldstein

Expert Report at 0007); PX0349 (Burnett, Dep. at 87-90)).

1171. The NO activates the enzyme guanylate cyclase within the vascular smooth muscle cells that results in

increased levels of cyclic guanosine monophosphate (cGMP), an effector of smooth muscle relaxation via protein

kinase G (PKG) actions. (PX0149 (Burnett Expert Report at 0004-05); PX0189 (Goldstein Expert Report at 0007);

PX0349 (Burnett, Dep. at 87-90)).

1172. NO, cGMP and PKG mediate the relaxation of the cavernous smooth muscle and vasodilation of blood

vessels. (PX0149 (Burnett Expert Report at 0004); PX0189 (Goldstein Expert Report at 0007)).

1173. Persistent smooth muscle relaxation leads to tissue engorgement within the corpora cavernosa and penile

erection. (PX0189 (Goldstein Expert Report at 0007)).

1174. Cyclic guanosine monophosphate is hydrolyzed by the phosphodiesterases, predominantly type 5 (“PDE5”),

to inactive 5'-GMP, terminating penile erection. (PX0149 (Burnett Expert Report at 0004-05); PX0349 (Burnett,

Dep. at 92-93)).

1175. PDE5 inhibitors such as sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis) inhibit PDE5, thereby

augmenting cGMP levels. (PX0149 (Burnett Expert Report at 0004-05); PX0349 (Burnett, Dep. at 93)).

1176. Endothelial NO function is fundamental to the vascular process of penile erection. (Burnett, Tr. 2290).

1177. The vascular function of vessels in various parts of the body behave similarly. (Burnett, Tr. 2290).

d. Antioxidant activity of pomegranate juice

*143 1178. Oxidative stress molecules in the body, which are produced by various kinds of conditions of

inflammatory change, disease states, etc., have deleterious effects throughout the body in the vasculature and in

the penis that actually counter-effect the body's NO regulatory mechanism, not just for transient effects to bring

about erection, but also to maintain the wellness of the erectile tissue. (PX0349 (Burnett, Dep. at 89-90); Burnett,

Tr. 2250-51; Goldstein, Tr. 2604-05; PX0190 at 0006).

1179. Antioxidants are well known to enhance the biological actions of NO by virtue of their capacity to stabilize

NO by protecting against the oxidative destruction of NO by oxidative stress molecules. (PX0056 at 0002; PX0059

at 0001, 0004; PX0190 at 0006; PX0149 (Burnett Expert Report at 0005-06); PX0189 (Goldstein Expert Report

at 0004-05); Goldstein, Tr. 2604-05).
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1180. The antioxidant effect described in F. 1179 results in much higher and more prolonged cellular

concentrations of NO, leading to markedly increased biological actions of NO. (PX0056 at 0002; PX0059 at 0001,

0004; PX0149 (Burnett Expert Report at 0005-06)).

1181. Antioxidants play a potential role in preserving erectile tissue health and function. (Burnett, Tr. 2285-86;

Goldstein, Tr. 2604-05).

1182. Pomegranate juice possesses potent flavonoid antioxidants. (PX0149 (Burnett Expert Report at 0005-06);

Burnett, Tr. 2250-51; PX0189 (Goldstein Expert Report at 0011); PX0056; PX0058; PX0051; PX0004).

1183. Pomegranate juice enhances the production of endothelial NO formation by suppressing the oxidative

stress molecules that oppose the endothelial NO synthase function. (PX0149 (Burnett Expert Report at 0005-06);

PX0349 (Burnett, Dep. at 103, 119); Burnett, Tr. 2251-54).

1184. Pomegranate juice possesses anti-oxidative molecular effects and these effects activate endothelial NO

mechanisms in vasculature which serve potential beneficial effects on vascular blood flow and promote vascular

biologic health of the penis. (PX0149 (Burnett Expert Report at 0005-06)).

3. Erectile dysfunction studies

1185. Respondents have sponsored two human studies addressing erectile dysfunction-related endpoints and

at least six in vitro and animal studies looking at NO metabolism in an effort to identify a potential erectile

dysfunction benefit from pomegranate juice. (CX1193 at 0001; CX0716 at 0029; PX0051 at 0001; PX0056 at

0001; PX0057 at 0001; PX0059 at 0001; PX0004 at 0001; PX0058 at 0001).

a. Tools for human clinical studies evaluating erectile function

1186. Both Complaint Counsel's and Respondents' erectile dysfunction experts agree it is important to use a

validated tool when conducting a human clinical trial investigating whether a product treats, prevents, or reduces

the risk of erectile dysfunction. (Melman, Tr. 1099; CX1289 (Melman Expert Report at 0010); Burnett, Tr. 2266

(agreeing that experts would rely on a validated tool when conducting a human clinical trial investigating whether

a product treats erectile dysfunction)).

*144 1187. A validated tool is “established as measuring erectile dysfunction through rigorous assessments

involving reliability testing, validity testing, construct validity, and other criteria.” (Burnett, Tr. 2266; see also

Melman, Tr. 1100 (stating that validation means that a measure has been shown to have statistical reliability)).

1188. Validation is important because “[r]igorous assessment of patient-reported outcomes is necessary to ensure

reliability, responsiveness, and discriminant and predictive validity. These attributes ensure that the instrument

measures what it states it measures, and that the results are reproducible and sensitive to change.” (PX0352a02

at 0002; PX0352 (Goldstein, Dep. at 55-56)).

1189. Dr. Melman testified that a study to support a treatment for erectile dysfunction must show that a man can

complete intercourse with sexual satisfaction and achieve orgasm. (Melman, Tr. 1141-43). See also Melman, Tr.

1146-47 (In the hypothetical case of “a man [that] hasn't been able to have an erection for five years, then he

tries [a] product and he now has an erection and he can penetrate his wife and bring her to sexual satisfaction,
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but he doesn't have an orgasm himself,” the maker of the product “can't tell the public about what [the product

has] done.”).

i. The IIEF

1190. The International Index of Erectile Function (“IIEF”) is a validated measure for evaluating change in erectile

function. (JX0003 ¶ A.9; Melman, Tr. 1099; CX1289 (Melman Expert Report at 0010); Burnett, Tr. 2293; PX0352

(Goldstein, Dep. at 65); CX1193 at 0002; see also CX1240 at 0003, in camera (stating in a pre-investigational

new drug application for POMx that the FDA considered the “erectile function domain of the IIEF ... as the most

appropriate measure of the efficacy of the product for treating erectile dysfunction”)).

1191. The IIEF is a 15 question psychometrically validated instrument designed to assess a man's overall erectile

and sexual function via the individual domains of erectile function, orgasmic function, sexual desire, intercourse

satisfaction and overall satisfaction. (PX0189 (Goldstein Expert Report at 0009); Melman, Tr. 1099-1101;

CX0686 at 0026-29; CX1193 at 0002 (stating that the “IIEF is a validated questionnaire whose erectile function

domain score has been demonstrated to correlate with ED [erectile dysfunction] intensity”)).

1192. The erectile function domain relates only to erectile performance and does not evaluate orgasm or

ejaculation. (Goldstein, Tr. 2604).

1193. The IIEF was designed for evaluating pharmaceuticals, not natural botanical products. (Goldstein, Tr.

2603-04).

1194. Dr. Goldstein, who was at the Pfizer Drug Company meeting where the IIEF was developed for its

pharmaceutical product Viagra, testified that the IIEF was originally intended for pharmaceutical products in

patients with IIEF scores consistent with erectile dysfunction. (PX0352 (Goldstein, Dep. at 67-69)).

*145 1195. The IIEF has some ambiguous questions. For example, one question asks how often do you get an

erection, but does not qualify as to what type of erection, i.e., mild erection; moderate erection, etc. (Goldstein,

Tr. 2603). Also, IIEF has deficiencies as it requires patient recall and involves patients' subjective interpretation

of their erection physiology. (Burnett, Tr. 2293-94).

ii. The GAQ

1196. The Global Assessment Questionnaire (“GAQ”) is not a validated measure for assessing erectile function.

(Melman, Tr. 1118; Burnett, Tr. 2294; PX0352 (Goldstein, Dep. at 73)).

1197. By itself, experts would not consider the GAQ to be a sufficient endpoint in a clinical study evaluating a

treatment for erectile dysfunction. (Burnett, Tr. 2294-95) (agreeing that the GAQ was more vague and nonspecific

than a validated tool in measuring whether a therapy had an effect on the ability to achieve and maintain erections).

1198. The GAQ is commonly accepted as a standardized instrument among those conducting erectile dysfunction

research. The GAQ's “clinical meaningfulness based on its simplicity makes it extremely widely used and very

important in assessing erectile function.” (Goldstein, Tr. 2602-03, 2634; Burnett, Tr. 2304; PX0349 (Burnett, Dep.

at 127); CX1337 (Forest, Dep. at 79)).
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1199. In the development of pharmaceutical products for sexual medicine, the FDA widely approves of nonvalidated, patient-reported outcomes, such as the GAQ. (PX0352 (Goldstein, Dep. at 57)).

1200. The GAQ does not measure the degree of improvement, indicate how often a study participant experienced

improved erections, or show whether he was able to complete sexual intercourse. (Melman, Tr. 1120, 1122;

CX1289 (Melman Expert Report at 0014)).

1201. The GAQ is a single yes/no question designed to assess the individual self-evaluation of the study treatment

(e.g., pomegranate juice consumption versus placebo consumption) effect on the patient's sexual health concern.

(PX0189 (Goldstein Expert Report at 0009); Goldstein, Tr. 2603).

1202. The GAQ is a very easy evaluation and written for a high school educated person to understand. (Goldstein,

Tr. 2603; CX1337 (Forest, Dep. at 151-52)).

1203. The GAQ is used in all sexual medicine trials. (Goldstein, Tr. 2603; PX0352 (Goldstein, Dep. at 57)).

1204. The GAQ was used by Pfizer in testing sildenafil (Viagra) and in every vardenafil (Levitra) and tadalafil

(Cialis) trial. (Burnett, Tr. 2304; Goldstein, Tr. 2602; PX0352 (Goldstein, Dep. at 57)).

1205. The GAQ is a very “acceptable,” informative,” and “valuable” tool to use for testing pomegranate juice.

(Burnett, Tr. 2294, 2304).

b. The Forest/Padma-Nathan Study

i. About the Forest/Padma-Nathan Study

1206. POM sponsored a study by Mr. Christopher Forest, Dr. Harin Padma-Nathan, and Dr. Harley Liker, titled,

Efficacy and Safety of Pomegranate Juice on Improvement of Erectile Dysfunction in Male Patients with Mild

to Moderate Erectile Dysfunction: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study (“Forest/

Padma-Nathan Study”). (CX1147 at 0004; CX1193 at 0001, 0004). The clinical trial was conducted in 2004 to

2005, and the results were later published in the International Journal of Impotence Research in 2007. (CX1193

at 0001; CX1147 at 0004).

*146 1207. Dr. Padma-Nathan, the principal investigator of the Forest/Padma-Nathan Study, received the

first fellowship from the American Foundation for Urologic Disease that was awarded in the area of erectile

dysfunction. The prestigious fellowship is awarded to two urologists annually. His work involved two years of

basic lab and in vitro scientific research in smooth muscle pharmacology cosponsored by the Department of

Urology and the Department of Cardiology at Boston University. (CX1338 (Padma-Nathan, Dep. at 23, 32-33)).

Dr. Padma-Nathan is a man of repute in the field of urology. (Heber, Tr. 2000).

1208. Mr. Forest, at the time of the Forest/Padma-Nathan Study, was Physician Assistant and Director of Clinical

Trials, working for Dr. Padma-Nathan. (CX1337 (Forest Dep. at 20)).

1209. Dr. Liker, POM's medical director, was involved with the design and conduct of the Forest/Padma-Nathan

Study. (See CX 1350 (Liker, Dep. at 191); CX0637 at 0001; CX0622 at 0001; CX0704 at 0001; CX0644 at

0001-02; CX0834 at 0001-02). Dr. Liker also reviewed and approved changes to the article prior to publication.

(CX0881 at 0001-02; see also CX0856 at 0001) (sending revised draft of manuscript to Dr. Liker)).
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1210. The Forest/Padma-Nathan Study was a randomized, double-blinded, placebo-controlled pilot study that

examined the efficacy of POM Juice versus placebo in improving erections in 53 men with mild to moderate

erectile dysfunction. (CX1193 at 0001; CX1289 (Melman Expert Report at 0012-13)).

1211. The Forest/Padma-Nathan Study used a crossover design, and the 53 participants who completed the study

received a different beverage during the two 28-day treatment periods. (CX1289 (Melman Expert Report at

0012-13); CX1193 at 0002-03). Participants in cohort one consumed POM Juice in period one and then switched

to the placebo beverage in period two. (CX1193 at 0002-03). Participants in cohort two consumed the placebo

beverage in period one and POM Juice in period two. (CX1193 at 0002-03).

1212. The Forest/Padma-Nathan Study used the GAQ as the primary outcome measure and the IIEF as the

secondary outcome measure. (CX1337 (Forest, Dep. at 84); CX1193 at 0002; Melman, Tr. 1120; CX0686 at 0008).

1213. The Forest/Padma-Nathan Study hypothesized that treatment of the participants with POM Juice would

produce: 1) statistically significant positive GAQ scores when compared to placebo-controlled patients, and 2)

changes in the erectile function domain of the IIEF when the values are compared with the baseline and between

the two groups. (CX0686 at 0008).

1214. The Forest/Padma-Nathan Study's GAQ asked participants the following yes or no question: “While using

the study beverage, did you feel that your erections improved?” (CX0686 at 0025).

1215. Dr. Padma-Nathan, the lead researcher, testified that while the GAQ is not a validated measure for measuring

erectile function, “it's not unreasonable to have it as a single question, to try to capture a signal for any evidence

of [erectile] treatment effect.” (CX1338 (Padma-Nathan Dep. at 90-91, 94)).

*147 1216. The erectile function domain questions of the IIEF have graded response scales and ask specific

questions relating to erectile function, such as “Over the last month, when you attempted sexual intercourse,

how often were you able to penetrate (enter) your partner?” and “Over the last month, during sexual intercourse,

how often were you able to maintain your erection after you had penetrated (entered) your partner?” (CX0686

at 0026-27; see also Melman, Tr. 1123).

1217. Dr. Padma-Nathan testified that the IIEF was a validated measure and the “gold standard.” (CX1338

(Padma-Nathan, Dep. at 90)).

1218. Dr. Padma-Nathan considered the Forest/Padma-Nathan RCT Study “a scientifically rigorous

study.” (CX1338 (Padma-Nathan Dep. at 196-97)).

1219. A study as scientifically rigorous as the Forest/Padma-Nathan RCT Study is almost unheard of in the food

industry. (Goldstein, Tr. 2601-02, 2613-14).

1220. Dr. Goldstein, indicated that as editor in chief of the International Journal of Impotence Research, the

Forest/Padma-Nathan Study “is the first and only nutraceutical clinical trial that is randomized and double-blind

that [he has] ever come across in [the] field.” (Goldstein, Tr. 2598).

ii. Results of the Forest/Padma-Nathan Study
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1221. Of the 53 participants who completed the Forest/Padma-Nathan Study, a total of 42 subjects demonstrated

improved GAQ scores, 25 after drinking pomegranate juice. (PX0189 (Goldstein Expert Report at 0012-13);

CX0908).

1222. In the pomegranate juice-placebo sequence, 56% demonstrated improvement of GAQ score versus 33% in

the placebo-pomegranate juice sequence. (PX0189 (Goldstein Expert Report at 0012-13); CX0908).

1223. In the placebo-pomegranate juice sequence, 38% versus 29% reported improvement in GAQ score. (PX0189

(Goldstein Expert Report at 0012-13); CX0908).

1224. Overall, the GAQ scores demonstrated that pomegranate juice drinkers enjoyed a nearly 50% better

improvement in erections over the placebo drinkers. (CX0908 at 0003; PX0352 (Goldstein, Dep. at 109, 144);

CX1338 (Padma-Nathan, Dep. at 191-92)).

1225. The Forest/Padma-Nathan Study's GAQ results achieved a probability value (“p-value”) of 0.058, which is

not statistically significant, as it is slightly above the statistical significance measure of 0.050. (PX0189 (Goldstein

Expert Report at 0012-13); CX0908; Heber, Tr. 1978; Goldstein, Tr. 2598). This means the study had a 94%,

rather than 95%, probability of being valid and not the result of chance. (Heber, Tr. 1978; Goldstein, Tr. 2599;

Burnett, Tr. 2305).

1226. The Forest/Padma-Nathan RCT Study's IIEF erectile function domain results achieved a p-value of 0.72,

which is not statistically significant. (Melman, Tr. 1120-21; Burnett, Tr. 2297 (agreeing that a p-value of 0.72 is

“nowhere near approaching statistical significance”); PX0352 (Goldstein, Dep. at 65); CX1193 at 0003; CX1213

at 0001 (comparing the change from baseline for the treatment group versus the control group)).

*148 1227. The Forest/Padma-Nathan Study report noted the treatment period was a limitation because it might

not have been long enough to allow for a clinical response. (CX1193 at 0004). See also Melman, Tr. 1125, 1127;

CX1289 (Melman Expert Report at 0014) (the study not conducted over a sufficient duration to show a sustained

clinically significant effect on erectile function).

1228. Dr. Padma-Nathan also testified that the Forest/Padma-Nathan RCT Study was “[u]nder-powered to achieve

statistical significance ... [but] that shouldn't be misconstrued to mean that the study was a deficient one.” (CX1338

(Padma-Nathan, Dep. at 106, 108)). Dr. Padma-Nathan further testified that he did not think they were “trying to

achieve [statistical significance] and didn't believe [they would] get statistical significance.” (CX1338 (PadmaNathan, Dep. at 106)).

1229. Dr. Padma-Nathan testified that the study concluded that there was a potential for pomegranate juice to

have beneficial effects on erectile dysfunction, with the caveat of the need for further studies to confirm. (CX1338

(Padma-Nathan, Dep. at 184)).

1230. Dr. Padma-Nathan and Mr. Forest testified that the study did not conclude that POM Juice treats, prevents,

or reduces the risk of erectile dysfunction. (CX1338 (Padma-Nathan, Dep. at 157-58); CX1337 (Forest, Dep. at

165-66)).

1231. After the Forest/Padma-Nathan Study was submitted for publication, a peer reviewer for the International

Journal of Impotence Research stated that it was “a negative study, not a positive study, and should be presented

that way.” (CX0856 at 0001).
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1232. A published review by Dr. Jacob Rajfer, Professor of Urology at UCLA, Pomegranate Juice: Is It the New,

All-Natural Phosphodiesterase Type 5 Inhibitor?, 10 Rev. Urol. 168-69 (2008), also stated that the Forest/PadmaNathan Study had negative results. (CX1290 at Ex. C; Melman, Tr. 1128-29; CX1289 (Melman Expert Report

at 0016)).

iii. Expert opinion on the Forest/Padma-Nathan Study

1233. Dr. Melman testified that the GAQ is not a validated measure for assessing erectile function; has not

been tested for statistical reliability; and does not measure the degree of improvement, indicate how often a

study participant experienced improved erections, or show whether he was able to complete sexual intercourse.

(Melman, Tr. 1118-22; CX1289 (Melman Expert Report at 0014)). Dr. Melman further testified that without

the ability to show meaningful change of erectile function, the GAQ does not provide clinically significant

information. (Melman, Tr. 1118-22; CX1289 (Melman Expert Report at 0014)).

1234. Dr. Melman had not heard of the term GAQ until being involved as an expert in this case and he formed

his opinions about the GAQ after being involved in this case. (Melman, Tr. 1180-81).

1235. Dr. Melman testified that the Forest/Padma-Nathan Study was not conducted over a sufficient duration to

show a sustained clinically significant effect on erectile function. (Melman, Tr. 1125, 1127; CX1289 (Melman

Expert Report at 0014)). Dr. Melman further opined that experts in the erectile dysfunction field would require that

a study be conducted over an appropriate duration because, even if there is improvement in the quality of erection,

a treatment is not efficacious when the participant is still unable to complete intercourse. (CX1289 (Melman

Expert Report at 0011-12)).

*149 1236. Dr. Melman testified that the Forest/Padma-Nathan Study's IIEF erectile function domain results

achieved a p-value of 0.72 and GAQ results achieved a p-value of 0.058, which are not statistically significant.

(Melman, Tr. 1120-21). Dr. Melman further testified that nearly achieving statistical significance is insufficient to

prove a product's efficacy in treating, preventing, or reducing the risk of erectile dysfunction in humans. (Melman,

Tr. 1103, 1121).

1237. Dr. Melman also testified that based on the results of an animal study and one study on 11 men, Dr. Melman

has made public statements that a gene-transfer therapy for erectile dysfunction called hMaxi-K would help erectile

dysfunction. (Melman, Tr. 1148, 1150, 1155).

1238. Respondents' experts testified that even though the statistical significance was not reached, the Forest/

Padma-Nathan Study “provides very valuable information” regarding erectile health and function and is absolutely

“clinically significant” because “it supports the conclusion that the positive results in the basic science are borne

out in human function.” (Goldstein, Tr. 2598-99, 2605, 2608; PX0352 (Goldstein, Dep. at 34-47, 105-09)).

1239. Dr. Goldstein testified that the results of the Forest/Padma-Nathan Study showed that “there were 50 percent

more people than the placebo who thought that there was erectile benefit from using this drug. And I will call

that clinically significant in conjunction with the fact that there are no deaths, no priapisms, no heart attacks, no

strokes, no flushing, no nasal congestion, none of the traditional side effects seen by PDE5 inhibitors. No need for

stents, drug-eluting stints, no need for surgery. No need for penile prosthetic procedures.” (PX0352 (Goldstein,

Dep. at 109)).

1240. Dr. Goldstein also testified that the Forest/Padma-Nathan Study “is of extreme relevance to the clinician

and consumer” and is “suggestive evidence that use of pomegranate juice would benefit [a] patient with erectile
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dysfunction.” (PX0189 (Goldstein Expert Report at 0014); Goldstein, Tr. 2605; PX0352 (Goldstein, Dep. at 34,

105-06)).

1241. Dr. Goldstein opined that the short treatment period in the Forest/Padma-Nathan Study “actually resulted

in less favorable findings such that one would anticipate that a more robustly designed study would certainly

have obtained statistically significant results.” (PX0189 (Goldstein Expert Report at 0013); PX0352 (Goldstein,

Dep. at 80)).

1242. Dr. Burnett testified that the results of the Forest/Padma-Nathan Study provide support that pomegranate

juice “may be an intervention that would complement conventional ED treatment, and [he] would support its use

by patients.” (Burnett, Tr. 2298).

1243. Dr. Burnett opined that the Forest/Padma-Nathan Study supports the conclusion that pomegranate juice has a

beneficial effect on erectile tissue physiology, health, and function, and is “a potential treatment for ED.” (PX0149

(Burnett Expert Report at 0006); Burnett, Tr. 2255-56, 2270; PX0349 (Burnett, Dep. at 103, 112, 116-18, 138-39,

142)).

*150 1244. Dr. Heber opined that the Forest/Padma-Nathan Study showed that consumption of POM juice

created a marked improvement in erectile function among men who had experienced erectile dysfunction, and

it had major clinical significance in showing a benefit from pomegranate juice despite barely missing statistical

significance. (Heber, Tr. 1830-31, 1979).

1245. Dr. Heber testified that the Forest/Padma-Nathan Study “could [not] be disregarded” and that “it is a positive

in providing important scientific information consistent with the basic science that pomegranate juice may be

helpful for men with erectile dysfunction.” (Heber, Tr. 2001).

iv. Determinations on the Forest/Padma-Nathan Study

1246. The GAQ is an adequate tool for testing a product like pomegranate juice. (Burnett, Tr. 2303-04).

1247. The Forest/Padma-Nathan Study's IIEF erectile function results of a p-value of 0.72 is not statistically

significant. (Melman, Tr. 1120-21; Burnett, Tr. 2297).

1248. The Forest/Padma-Nathan Study's GAQ results of a p-value of 0.058 was a few thousandths of a percentage

point short of the 95% threshold, and thus not “statistically significant.” (PX0189 (Goldstein Expert Report at

0012-13); CX0908; Heber, Tr. 1978; Goldstein, Tr. 2598-99; Burnett, Tr. 2305).

1249. As noted in the Forest/Padma-Nathan Study itself, the treatment period was a limitation because it might

not have been long enough to allow for a clinical response. (CX1193 at 0004).

1250. Despite the limitations stated in F. 1247-1249, the Forest/Padma-Nathan Study has clinical significance in

showing a benefit from pomegranate juice on erectile tissue physiology and health. (PX0189 (Goldstein Expert

Report at 0013); PX0149 (Burnett Expert Report at 0006); CX0908; Heber, Tr. 1979, 2001; Goldstein, Tr.

2598-99; PX0352 (Goldstein, Dep. at 108-09); Burnett, Tr. 2256; PX0349 (Burnett, Dep. at 138-39)).

1251. The Forest/Padma-Nathan Study supports the conclusion that pomegranate juice has a beneficial effect on

erectile tissue physiology, health, and function. (PX0149 (Burnett Expert Report at 0006); Burnett, Tr. 2255-56;

PX0349 (Burnett, Dep. at 103, 112, 116-18, 138-39, 142)).
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1252. The Forest/Padma-Nathan Study supports the conclusion that pomegranate juice is a potential treatment for

erectile dysfunction. (PX0349 (Burnett, Dep. at 142); CX1338 (Padma-Nathan, Dep. at 184)).

1253. The Forest/Padma-Nathan Study does not support the conclusion that POM Juice treats, prevents, or reduces

the risk of erectile dysfunction. (CX1338 (Padma-Nathan, Dep. at 157-58); CX1337 (Forest, Dep. at 165-66);

PX0349 (Burnett, Dep. at 142)).

c. Davidson BART/FMD Study

1254. A subset of 27 participants from the Davidson BART/FMD Study, a randomized, double blind, and placebocontrolled cardiovascular study funded by Roll (discussed in F. 903), also completed the IIEF questionnaire.

(CX1065 at 0001; CX0716 at 0029; CX0684 at 0001, 0014). This analysis was planned for in the protocol for the

Davidson BART/FMD Study. (CX0716 at 0029).

*151 1255. The Davidson BART/FMD Study was primarily a cardiovascular study and therefore its protocols did

not include any of the type of inclusion or exclusion criteria one would expect to see in a basic erectile dysfunction

clinical trial. (CX0716; PX0019; Melman, Tr. 1092).

1256. The unpublished IIEF results from the Davidson BART/FMD Study were not statistically significant for the

intent to treat population. (Melman, Tr. 1130-31; CX1289 (Melman Expert Report at 0017); CX1336 (Davidson,

Dep. at 88-89)). The p-value was 0.7887 when comparing the intent to treat population's change in IIEF erectile

function domain scores for the treatment group versus the control group. (CX0684 at 0014).

1257. The erectile dysfunction findings in the Davidson BART/FMD Study were flawed since one of the two study

sites was unable to collect any data for the baseline IIEF measurement. (CX0654 at 0001 (“IIEF data not collected

on most subjects at site 2; Mary Sue was aware of this and site staff reported that subjects are uncomfortable

completing this questionnaire in the office (close quarters) so they tried to send it to them prior to their visit for

them to bring in completed, yet it still was incomplete. Unfortunately, this baseline data will be missing.”)).

1258. Neither Dr. Burnett nor Dr. Goldstein reviewed the IIEF data from the Davidson BART/FMD Study.

(PX0352 (Goldstein, Dep. at 142); PX0349 (Burnett, Dep. at 170)).

1259. The IIEF results from Davidson BART/FMD study do not support the conclusion that drinking eight ounces

of POM Juice daily treats, prevents, or reduces the risk of erectile dysfunction. (Melman, Tr. 1130-31; CX1289

(Melman Expert Report at 0017)).

d. Nitric oxide studies

i. Studies sponsored by Respondents

1260. Respondents have sponsored at least six in vitro and/or in vivo studies investigating the effects of

pomegranate juice on NO levels, including:

• Pomegranate Juice Consumption Reduces Oxidative Stress, Atherogenic Modifications to LDL, and Platelet

Aggregation: Studies in Humans and in Atherosclerotic Apolipoprotein E-Deficient Mice, by Dr. Aviram;

• Oxidative Stress in Arteriogenic Erectile Dysfunction: Prophylactic Role of Antioxidants, by Dr. Azadzoi;
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• Effects of a Pomegranate Fruit Extract Rich in Punicalagin on Oxidation-Sensitive Genes and eNOS Activity at

sites of Perturbed Shear Stress and Atherogenesis, by Dr. de Nigris;

• The Influence of Pomegranate Fruit Extract in Comparison to Regular Pomegranate Juice and Seed Oil on

Nitric Oxide and Arterial Function in Obese Zucker Rats, by Dr. de Nigris;

• Beneficial Effects of Pomegranate Juice on Oxidation-Sensitive Genes and Endothelial Nitric Oxide Synthase

Activity at Sites of Perturbed Shear Stress, by Dr. de Nigris; and

• Pomegranate Juice Protects Nitric Oxide Against Oxidative Destruction and Enhances the Biological Actions

of Nitric Oxide, by Dr. Ignarro.

*152 (PX0051 at 0001; PX0056 at 0001; PX0057 at 0001; PX0059 at 0001; PX0004 at 0001; PX0058 at 0001).

1261. Respondents' in vitro and in vivo studies are “basic science” or “pre-clinical.” (PX0149 (Burnett Expert

Report at 0005-06); PX0189 (Goldstein Expert Report at 0010-13) (describing the de Nigris, Aviram, Ignarro,

and Azadzoi studies as in vitro or in vivo); CX0982 at 0011-14 (describing the de Nigris, Aviram, Ignarro, and

Azadzoi studies as “pre-clinical” studies)).

(a) Dr. Aviram's Study

1262. Dr. Aviram is a distinguished professor of biochemistry and researcher at the Technion Faculty of Medicine

and the Rambam Medical Center in Haifa, Israel, and head of the Lipid Research Laboratory. (PX0004; CX1358

(Aviram, Dep. at 7-8)).

1263. Dr. Melman, described Technion Institute in Haifa, Israel as a “terrific” institution. (Melman, Tr. 1168).

1264. For over 30 years, Dr. Aviram's major research focused on antioxidants in general, and on its dietary role

in cardiovascular disease. (CX1358 (Aviram, Dep. at 5)).

1265. Dr. Aviram has concluded, based on his medical research, that pomegranate juice had greater antioxidant

potencies than red wine, which he believed at the time possessed the most potent antioxidant. (CX1358 (Aviram,

Dep. at 5-6)).

1266. Dr. Aviram's Study, titled, Pomegranate juice consumption reduces oxidative stress, atherogenic

modifications to LDL, and platelet aggregation: studies in humans and in atherosclerotic apolipoprotein Edeficient mice, reported that dietary supplementation with nutrients rich in antioxidants was associated with

inhibition of atherosclerosis. (PX0189 (Goldstein Expert Report at 0012); PX0004).

1267. Dr. Aviram and his colleagues studied, in healthy male volunteers and in atherosclerotic apolipoprotein

E-deficient mice, the effect of consumption of pomegranate juice on such outcomes as lipoprotein oxidation,

aggregation and retention, macrophage atherogenicity, platelet aggregation and atherosclerosis. (PX0189

(Goldstein Expert Report at 0012); PX0004).
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1268. Dr. Aviram and colleagues found that in humans, pomegranate juice consumption decreased low-density

lipoprotein (“LDL”) susceptibility to aggregation and retention and increased an high-density lipoprotein (“HDL”)

associated esterase that can protect against lipid peroxidation. (PX0189 (Goldstein Expert Report at 0012);

PX0004).

1269. Similar positive anti-atherosclerosis effects were seen in the E-deficient mice. (PX0189 (Goldstein Expert

Report at 0012); PX0004).

1270. Dr. Aviram and colleagues concluded that pomegranate juice had potent antiatherogenic effects in humans

(and atherosclerotic mice) that may be attributable to its antioxidative properties. (PX0189 (Goldstein Expert

Report at 0012); PX0004).

1271. Dr. Goldstein noted that Dr. Aviram's Study is “a very fascinating and very important piece of

information.” (PX0352 (Goldstein, Dep. at 127)).

(b) Dr. Azadzoi's Study

*153 1272. Dr. Azadzoi is a distinguished research professor of urology and pathology at the Boston University

School of Medicine and Director of Urology Research at the Veterans Affairs Boston Healthcare System.

(PX0051).

1273. Dr. Azadzoi, along with Dr. Goldstein, developed an atherosclerotic animal model for erectile dysfunction.

(Goldstein, Tr. 2595).

1274. Dr. Azadzoi has published extensively on studies using atherosclerotic animal models with erectile

dysfunction. (Goldstein, Tr. 2595).

1275. Dr. Azadzoi's Study, titled, Oxidative Stress in Arteriogenic Erectile Dysfunction: ProphylacticRrole of

Antioxidants, studied the antioxidant properties of various fruit juices, such as orange juice, blueberry juice,

and cranberry juice, and other known antioxidant beverages such as green tea and red wine, and reported that

pomegranate juice possessed the highest free radical scavenging capacity. (PX0189 (Goldstein Expert Report at

0011-12); PX0051; PX0352 (Goldstein, Dep. at 123-24); Goldstein, Tr. 2595).

1276. Dr. Azadzoi and colleagues examined that effect of various antioxidant beverages on arteriogenic erectile

dysfunction in rabbits that demonstrated decreased intracavernous blood flow, erectile dysfunction, loss of smooth

muscle relaxation, decreased endothelial NO synthase, and neuronal NO synthase, diffuse cavernosal fibrosis and

increased cavernous levels of the oxidative product isoprostane 8 — epi — prostaglandin F 2 alpha. (PX0189

(Goldstein Expert Report at 0011-12); PX0051).

1277. Dr. Azadzoi and colleagues found that long term pomegranate juice intake increased intracavernosal blood

flow, improved erectile responses, improved smooth muscle relaxation, and decreased erectile tissue fibrosis.

(PX0189 (Goldstein Expert Report at 0011-12); PX0051; PX0352 (Goldstein, Dep. at 123); Goldstein, Tr.

2595-97).

1278. Dr. Azadzoi and colleagues concluded that arteriogenic erectile dysfunction accumulates oxidative products

in erectile tissues and that oxidative stress may be of great importance in the pathophysiology of erectile

dysfunction. (PX0189 (Goldstein Expert Report at 0011-12); PX0051).
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1279. Dr. Azadzoi and colleagues found that antioxidant therapy may be useful as a prophylactic for preventing

smooth muscle dysfunction and fibrosis in erectile dysfunction. (PX0189 (Goldstein Expert Report at 0011-12);

PX0051).

(c) Dr. de Nigris Study One

1280. Dr. de Nigris, of the Department of General Pathology and Excellence Research Center on Cardiovascular

Diseases of the 1st School of Medicine at the II University of Naples, Italy, and colleagues, including Dr. Louis

Ignarro, evaluated the effects of intervention with pomegranate juice on oxidation-sensitive genes and endothelial

NO synthase expression induced by high shear stress in vitro and in vivo. (PX0059). The study was titled,

Beneficial effects of pomegranate juice on oxidation-sensitive genes and endothelial nitric oxide synthase activity

at sites of perturbed shear stress, and is referred to herein as “de Nigris Study One.” (PX0059).

*154 1281. Cultured human coronary artery endothelial cells exposed to high shear stress in vitro and

hypercholesterolemic mice were used in the de Nigris Study One. (PX0059).

1282. Dr. de Nigris and colleagues found that pomegranate juice concentrate reduced the activation of redoxsensitive genes and increased endothelial NO synthase expression in cultured human coronary artery endothelial

cells and hypercholesterolemic mice. (PX0059; Burnett, Tr. 2290).

1283. Dr. de Nigris and colleagues also found that oral administration of pomegranate juice to

hypercholesterolemic mice at various stages of disease reduced significantly the progression of atherosclerosis.

(PX0059).

1284. The de Nigris Study One indicates that polyphenolic antioxidants contained in pomegranate juice can

contribute to the reduction of oxidative stress and atherogenesis. (PX0059; Burnett, Tr. 2290).

(d) Dr. de Nigris Study Two

1285. In a study titled, Effects of a Pomegranate Fruit Extract rich in punicalagin on oxidation-sensitive genes and

eNOS activity at sites of perturbed shear stress and atherogenesis, (referred to herein as de Negris Study Two),

Dr. de Nigris and colleagues showed that atherosclerosis is enhanced in arterial segments exposed to perturbed

shear stress as a result of increased expression of oxidation-sensitive responsive genes. (PX0189 (Goldstein Expert

Report at 0010-11); PX0056).

1286. The authors of the de Nigris Study Two studied the effect of pomegranate fruit extract and pomegranate

juice antioxidant activity on reduction of oxidative stress and atherogenesis during disturbed shear stress flow

using cultured human coronary artery endothelial cells. (PX0189 (Goldstein Expert Report at 0010-11); PX0056).

1287. The de Nigris Study Two showed that pomegranate fruit extract and pomegranate juice reduced the

activation of oxidation-sensitive genes and increased endothelial NO synthase expression. (PX0189 (Goldstein

Expert Report at 0010-11); PX0056).

1288. The de Nigris Study Two also showed that pomegranate fruit extract and pomegranate juice increased cyclic

GMP levels. (PX0189 (Goldstein Expert Report at 0010-11); PX0056).
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1289. The de Nigris Study Two further showed that administration of pomegranate juice reduced the progression

of atherosclerosis in hypercholesterolemic mice. (PX0189 (Goldstein Expert Report at 0010-11); PX0056).

1290. The authors of the de Nigris Study Two concluded that the proatherogenic effects of perturbed shear stress

can be reversed with chronic administration of pomegranate fruit extract. (PX0189 (Goldstein Expert Report at

0010-11); PX0056).

1291. The authors of the de Nigris Study Two also stated that some large clinical trials for different antioxidants

have failed to show any beneficial effect in terms of preventing major cardiovascular events. (PX0056 at 0008).

(e) Dr. Ignarro's Study

1292. Dr. Louis Ignarro has won a Nobel prize for his discoveries concerning NO. Dr. Ignarro conducted an

in vitro study, titled, Pomegranate juice protects nitric oxide against oxidative destruction and enhances the

biological actions of nitric oxide, to evaluate pomegranate juice's capacity to protect nitric oxide against oxidative

destruction. (PX0189 (Goldstein Expert Report at 0011); PX0058; Goldstein, Tr. 2593-95; Heber, Tr. 1995-96;

Burnett, Tr. 2252-53).

*155 1293. Dr. Ignarro has tested pomegranate juice for its capacity to protect NO against oxidative destruction

and found that pomegranate juice was around 5,000 times more potent than the other antioxidants he has tested

and possesses more antioxidant activity than grape juice, blueberry juice, red wine and ascorbic acid. (PX0189

(Goldstein Expert Report at 0011); Goldstein, Tr. 2594-95; Heber, Tr. 1967; Burnett, Tr. 2253; PX0058).

1294. Based on a series of studies that were performed on vascular endothelial cells, Dr. Ignarro concluded

that pomegranate juice possesses potent antioxidant activity that results in marked protection of NO against

oxidative destruction, thereby augmenting the biologic actions of NO. (PX0189 (Goldstein Expert Report at 0011);

PX0058).

1295. Dr. Goldstein testified that the “Ignarro study is another part of the sequence of evidence that supports that

a nutraceutical, specifically pomegranate juice, has incredible vascular-sparing properties that ultimately, when

you follow this path leads to the improvement of erectile function in men with erectile health issues.” (PX0352

(Goldstein, Dep. at 133)).

1296. Dr. Goldstein testified also that “you have to study humans to make statements about humans.” (PX0352

(Goldstein, Dep. at 124)).

1297. Complaint Counsel's expert, Dr. Melman, recognizes that Dr. Ignarro is highly respected and that UCLA

School of Medicine, where Dr. Ignarro is a professor in molecular and medical pharmacology, has a good

reputation. (Melman, Tr. 1167-68).

ii. Expert opinions on the basic science relied upon by Respondents

1298. Dr. Burnett, offered the following expert opinions regarding the basic science relied upon by Respondents:

• “basic scientific evidence exists that establishes that pomegranate juice possesses potent antioxidative molecular

effects and these effects operate by activating endothelial NO mechanisms in vasculature [structures involved in

human penile erection].” (PX0149 (Burnett Expert Report at 0005-06));
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• basic science alone “support[s] the potential benefit at the human level to improve the physiology of erectile

tissue preserving erect tissue health.” (PX0149 (Burnett Expert Report at 0004-05); PX0349 (Burnett, Dep. at

103, 112, 116-18)); and

• on the basis of animal studies or in vitro studies, pomegranate juice has a “potential benefit ... to likely improve

one's erection physiology.” (Burnett, Tr. 2262-63).

1299. Dr. Goldstein provided the following expert opinions regarding the basic science relied upon by

Respondents:

• “pomegranate juice has excellent basic science both in animal tissue and human tissue and excellent animal

model data.” (PX0352 (Goldstein, Dep. at 51-52)); and

• POM's “strong in vitro and in vivo studies ... suggest a probable benefit of pomegranate juice on erectile health,”

and that “in and of itself it has shown huge pieces of information that will be helpful in understanding how it

would work in humans ....” (PX0189 (Goldstein Expert Report at 0013); Goldstein, Tr. 2644).

*156 1300. Dr. Goldstein also provided the following expert opinions:

• competent and reliable scientific evidences shows that pomegranate juice provides a benefit to erectile function.

(Goldstein, Tr. 2605); and

• competent and reliable scientific evidence exists upon which clinicians who treat men with erectile health

concerns would rely in concluding that pomegranate juice promotes erectile health. (PX0189 (Goldstein Expert

Report at 0014)).

1301. Dr. Melman provided the following expert opinions regarding the basic science relied upon by Respondents:

• basic research studies about antioxidants' effects on NO levels may relate to the biochemical process for erectile

function. (CX1289 (Melman Expert Report at 0017-18)); and

• basic research studies do not directly involve erectile function in humans and cannot alone prove that POM

Juice treats, prevents, or reduces the risk of erectile dysfunction in humans. (CX1289 (Melman Expert Report

at 0017-18)).

1302. Notwithstanding Dr. Melman's opinion in F. 1301, Dr. Melman also testified that based on the results in an

animal model testing gene therapy erectile dysfunction product (see F. 653), he was “personally satisfied” that it

would also work in humans. (PX0360 (Melman, Dep. at 56-57)).

4. Determinations

1303. There is no true preventative intervention for erectile dysfunction. There are a wide variety of interventions

believed to have some potential benefit, anything from dietary changes to weight loss and perhaps things that
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are still being evaluated, although the role played is not sure. Because these interventions seem to be potentially

beneficial and do not necessarily have harms, physicians feel comfortable in promoting them. (PX0349 (Burnett

Dep. at 79); Burnett, Tr. 2301, 2272-73).

1304. “[T]reatment can have different meanings .... [T]reatment in the context of a pharmaceutical drug that is

approved by the FDA as an intervention for a disease may have a different meaning ... than the broad term of

treatment, which is to intervene for a condition.” (Burnett, Tr. 2312).

1305. Pomegranate juice “could be a treatment [to erectile dysfunction] in the sense that it offers some potential

health benefits.” (Burnett, Tr. 2312).

1306. Urologists would recommend pomegranate juice as a management tool to promote erectile health in men

who are aware that their erectile function is declining but who do not yet meet the clinical definition of erectile

dysfunction under the IIEF and therefore do not qualify for pharmacologic treatment. (PX0189 (Goldstein Expert

Report at 0014-0015); PX0352 (Goldstein, Dep. at 42-45); Goldstein, Tr. 2609).

1307. Urologists would recommend pomegranate juice as a complement to conventional erectile dysfunction

treatment. (Burnett, Tr. 2298, 2313; PX0349 (Burnett, Dep. at 78-79)) (“To the extent that any intervention out

there has some potential benefit of a better benefit than harm that meets some level of safety, I would support that

intervention, at least as a complimentary intervention and not a mainstay of ED treatment.”) (PX0352 (Goldstein,

Dep. at 80) (there are patients in whom there are erectile dysfunction and/or erectile health problems related to

inflammatory endothelial dysfunctions, and ... pomegranate juice has a logical context in the treatment of those

patients.”).

*157 1308. Dr. Goldstein “would strongly suggest and encourage” use of pomegranate juice to treat erectile

dysfunction in a subpopulation of men who have had an insufficient response to PDE5 inhibitors (like Viagra,

Levitra and Cialis) and who wish to reestablish erectile function without invasive or mechanical technology or

therapies. (PX0352 (Goldstein, Dep. at 37-42, 46)). Dr. Goldstein opined that the consumption of pomegranate

juice is a logical option for men who are not responsive to conventional drugs designed to treat erectile dysfunction

and who are unwilling to consider invasive or mechanical therapies for treatment of their erectile dysfunction.

(PX0189 (Goldstein Expert Report at 0005); PX0352 (Goldstein, Dep. at 37-42); Goldstein, Tr. 2605, 2641).

1309. Pomegranate juice costs far less than Viagra and there are no side effects to drinking pomegranate juice.

(PX0352 (Goldstein, Dep. at 44).

5. Conclusions

1310. The available body of scientific literature — including in vitro, in vivo, and preliminary clinical trials —

suggests that consuming pomegranate juice promotes erectile health. (PX0189 (Goldstein Expert Report at 0003)).

1311. The use of pomegranate juice to promote erectile health is a separate and distinct concept from the use of

this neutraceutical as a safe and effective treatment for the medical condition of erectile dysfunction such as with

a PDE5 inhibitor. (PX0189 (Goldstein Expert Report at 0004) (emphasis in original)).

1312. Competent and reliable scientific evidence shows that pomegranate juice provides a benefit to promoting

erectile health and erectile function. (Goldstein, Tr. 2605, 2608; PX0189 (Goldstein Expert Report at 0014);

PX0149 (Burnett Expert Report at 0006); Burnett, Tr. 2255-56).
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1313. There is insufficient competent and reliable scientific evidence to show that pomegranate juice prevents

or reduces the risk of erectile dysfunction or has been clinically proven to do so. (Burnett, Tr. 2274, 2300-01;

CX1289 (Melman Expert Report at 0018)).

1314. There is insufficient competent and reliable scientific evidence to show that pomegranate juice treats erectile

dysfunction in a clinical sense or has been clinically proven to do so. (Burnett Tr. 2285, 2300; Goldstein, Tr. 2611;

CX1289 (Melman Expert Report at 0018). See also Burnett, Tr. 2261-64).

J. Materiality

1. Overview

1315. Mrs. Resnick believes that part of the intrinsic value of pomegranate juice is that it has been shown to reduce

arterial plaque and factors leading to atherosclerosis and was shown to have a “powerful effect against prostate

cancer.” (L. Resnick, Tr. 75-76).

1316. Mr. Resnick testified that POM communicates to consumers the “[company's] belief that pomegranate juice

is beneficial in treating some causes of impotence, for the purpose of promoting sales of its product.” (CX1372

(S. Resnick, Tropicana Dep. at 45)).

1317. Mr. Resnick acknowledged that the kinds of benefits revealed by POM's research results are the

primary reason people buy pomegranate juice. (CX1372 (S. Resnick, Tropicana Dep. at 31)). Mr. Resnick also

acknowledged that consumers buy pomegranate juice “because they believe and in fact it does postpone the onset

of prostate cancer, which postpones the onset of death.” (CX1376 (S. Resnick, Ocean Spray Dep. at 217)).

*158 1318. Mr. Resnick expressed his belief that a great deal of consumers are buying POM Juice because they

believe “that we've proven that ... [POM Juice] really does prolong people's lives if they are getting the onset of

prostate cancer.” (CX1376 (S. Resnick, Ocean Spray Dep. at 218-19)).

1319. According to a draft creative brief for POMx dated October 12, 2006, the concept behind communicating

the amount of money the company spent on research is: “We don't just say our product is great, we have clinical

studies that prove its efficacy.” (CX0409 at 0057).

1320. POM was aware that among those purchasing the POM products were “people that have heart disease or

prostate cancer in their family, or have a fear of having it themselves.” (CX1368 at 17 (L. Resnick, Welch Dep.

at 67)).

1321. According to a September 2006 press article, Ms. Posell, POM's then vice president of corporate

communications, said “every time new research is released touting” a health benefit of pomegranate juice, “there

is a spike in sales. The study ... linking the consumption of pomegranate juice to a reduction in prostate cancer

was especially helpful, she said ... Pom Wonderful can see the results in increased sales every time a new study

surfaces.” (CX0433 at 0004).

1322. According to a July 2004 e-mail from John Regal, POM's head of marketing at the time, with the subject line

“POM Medical research timing and advertising”, POM's goal for its 2-page Prevention “advertorial” (CX0029,

F. 297-305, supra) was to convey “how POM is particularly good for clean & healthy arteries. We also wanted

to highlight the new Aviram study regarding plaque reduction in humans.” (Leow, Tr. 437; CX0667 at 0001).
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1323. In evaluating how copy dense or medically oriented to make a planned POMx Pill advertisement, Ms.

Kuyoomjian, Senior Vice President of Marketing for POM from 2008 to 2009, reminded Mrs. Resnick in a January

2009 e-mail: “you'll recall that a previous ad test with less copy did not generate as many orders. That would

suggest we keep the research info in the new ad, which would make it information dense as well.” (CX1357

(Kuyoomjian Dep. at 22); CX0266 at 0002).

1324. Mr. Perdigao, the head of Fire Station, Roll's in-house advertising agency used by POM (F. 134, 138), noted

in an e-mail dated June 11, 2009, that the “consumer benefit” of proposed advertisements that did not reference

prostate health or heart health was less compelling than more general references to POM being good for you

because it offers antioxidants that reduce free radicals. As Mr. Perdigao explained, less specific advertising is

generally less provocative. (CX0320 at 0002; L. Resnick, Tr. 90; see also Perdigao, Tr. 670-73).

1325. A creative brief (see F. 145-151) for the POM Wonderful website, from June 2008, stated the objective for

the assignment was to “tell the story (health benefits, research & how POM fits).” For the “Health Benefits” section

of the POM Wonderful website, the creative brief further stated that, to engage viewers, the page should identify

“What are the health benefits?”, including “heart health,” “prostate health,” and “E.D.”; “How does it work?”,

including antioxidant and anti-inflammatory properties, the “commitment” to research; “What the experts say,”

on such matters as heart and prostate, and a “comprehensive research database,” searchable by subject matter,

including heart and prostate, and by results. The directed tone and manner included “authoritative.” (CX0200 at

0001-02).

*159 1326. Ms. Leow, a creative director for Roll, stated that scientific information in advertising and marketing

material helps sell the products, because the scientific information provided the consumer with a “reason to

believe.” (Leow, Tr. 512-13; CX0095).

1327. A creative brief for POMx Pills, dated September 1, 2006, included the sentence in an opening narrative

paragraph, as a bullet point: “main creative focus is prostate cancer.” (CX0409 at 0023).

1328. A creative brief for POMx Pills, dated September 5, 2006, stated under “benefit,” in bold type, “Main

creative focus for 1st round is prostate cancer. (The benefits are from the studies — which showed a decrease in the

doubling time of PSA levels).” The “benefit” section continued: “The other versions of the creative [brief] should

definitely focus on the other benefits of POM — antioxidant, anti-aging, heart health, etc.” (CX0409 at 028).

1329. Respondents' marketing expert, Dr. David Reibstein, stated that it was indeed possible, and he would

expect that, consumers in POM's target audience who were concerned about heart disease would find a claim that

drinking a bottle of POM Juice a day prevents or treats heart disease to be important, that those concerned about

prostate cancer would find a prostate cancer prevention or treatment claim important, and that those concerned

about erectile dysfunction would find an erectile dysfunction prevention or treatment claim important. (PX0356

(Reibstein, Dep. at 117-19)).

2. OTX A&U Study and Zoomerang survey

1330. In the ordinary course of business, POM conducted consumer research to understand the characteristics,

attitudes and usage habits of their customers and to identify barriers and opportunities for increasing consumption,

particularly vis-à-vis other brands of pomegranate juice. (CX0370 at 0002; CX0292; CX0136; CX0453 at 0004).

1331. In June 2009, OTX, a consumer research firm, conducted an Attitudes and Usage consumer survey (“OTX

A&U Study”) on POM's behalf. (CX0370 at 0002, 0004; PX0227). The A&U Study's sample included current and
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former POM Juice drinkers, other pomegranate juice drinkers and users of other antioxidant fruit juices. (CX0370

at 0003).

1332. In the OTX A&U Study, among other things, current pomegranate juice users, including users of POM

Juice, were asked why they drink pomegranate juice, and were given a list of options, including: “It's healthy/good

for my health,” “I like the taste,” “I like pomegranates,” “it's all natural,” or “Other (specify”), and were directed

to select all that applied. (PX0227 at 0006). Among the POM Juice drinkers, 85% said they drank pomegranate

juice because “it's healthy good for my health,” 75% said “I like the taste,” 59% said “I like pomegranates,” 50%

said “it's all natural,” 29% said “it's new/interesting food trend,” and 4% said “other.” (CX0370 at 0011).

1333. Those in the OTX A&U Study that responded, “It's healthy/good for my health,” were asked a follow-up

question, “Which specific health reasons below describe why you personally drink pomegranate juice?” and were

presented with a list of reasons, depending on whether they were male or female. (CX0370 at 0012; PX0227 at

0006; Reibstein, Tr. 2558-59; Mazis, Tr. 2682-84).

*160 1334. The choices given to the survey respondents identified in F. 1333 were: helps promote heart health;

helps protect against prostate cancer [for males only]; helps protect against other cancers (besides prostate);

contains naturally occurring antioxidants; will help me live longer; helps improve thinking and memory; good

for bone and joint health; helps protect against urinary tract infections; provides immunity from colds and

flu; promotes healthy pregnancy [for females only]; promotes menstrual health [for females only] and “[o]ther

(specify).” (PX0227 at 0006).

1335. Among the POM Juice drinkers responding to the question in F. 1334, 91% said “contains naturally

occurring antioxidants,” 57% said “helps promote heart health,” 47% of men said “helps protect against prostate

cancer,” 45% said “provides immunity from colds and flu,” 43% said “helps protect against other cancers

(besides prostate); 38% said “helps protect against urinary tract infections,” 28% said “will help me live

longer,” 28% said “good for bone and joint health,” 25% said “helps improve thinking and memory,” 14% said

“promotes menopausal/post-menopausal health,” 6% said “promotes healthy pregnancy,” and 2% said “other.”

The percentages attributed for the different responses attributable to non-POM Juice and other antioxidant

beverage drinkers were slightly less. (CX0370 at 0012).

1336. POM's Senior Vice President of Marketing, Ms. Kuyoomjian, was not surprised by the OTX A&U Study

result that, for 47% of male POM users, part of the reason they drink POM Juice is because they believe it helps

protect against prostate cancer. (CX1357 (Kuyoomjian, Dep. at 259-60)).

1337. Dr. Reibstein reviewed the OTX A&U Study and concluded that although it presented some information

contradictory to the conclusions he drew from his own survey (see F. 1344-1372), the OTX A&U Study had

methodological flaws, cannot be relied upon, and does not invalidate the results of Dr. Reibstein's survey. (PX0223

(Reibstein Expert Report at 0021)).

1338. In rebuttal to the opinion of Respondents' expert Dr. Reibstein, that the OTX A&U Study was not reliable

or relevant (F. 1337), Complaint Counsel's expert, Dr. Mazis, reviewed the OTX A&U Study and expressed his

opinion that the OTX A&U Study was highly relevant and demonstrated that the heart disease and prostate cancer

claims are important to consumers, and are reasons that POM Juice users choose to purchase POM Juice. (Mazis,

Tr. 2688-89, 2760; CX1297 (Mazis Expert Report at 0012-13)).

1339. Dr. Mazis testified that, with respect to the likely importance that the challenged claims would have on

consumers' purchase or use decisions, he finds the OTX A&U Study more reliable than the Reibstein Survey (see

F. 1344-1372; Mazis, Tr. 2689).
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1340. In Dr. Reibstein's opinion, the OTX A&U Study used closed-ended questions, in that it provided respondents

with a list of five choices as to why they drink pomegranate juice, and that this method “cues” the survey

respondent to certain answers, excludes other potential answers that were not included on the list of choices, and

inflates results. (PX0227 at 0006; Reibstein, Tr. at 2518-20).

*161 1341. Dr. Mazis opined that, when studying purchase motivations, the use of closed-ended questions have

an advantage because it allows the researcher to get some specificity, and, therefore, closed-ended questions tend

to be used in most of these types of studies. Although close-ended questions have a disadvantage in that they may

lead to some upward bias, in a study like the OTX A&U Study, one accounts for this by giving a long list of choices,

as was done in the OTX A&U Study, and examining the relative ranking of responses. (Mazis Tr. 2662-63).

1342. In August 2007, Respondents commissioned a Zoomerang online survey of the general public, “to better

understand pomegranate and non-pomegranate juice consumers,” with respect to, among other things, “importance

of certain health benefits.” The survey included 287 heavy pomegranate juice drinkers. Six health benefits were

listed and these respondents were asked to rank which health benefit was the most important to them personally.

For heavy pomegranate juice drinkers, the number one response, for both males and females was “cardiovascular,”

and the number two choice for men was “prostate.” (See CX0292 at 0025; CX0136 at 0001, 0003, 0006).

1343. For members of the general public responding to the Zoomerang survey question regarding ranking of health

benefits (F. 1342), 60% ranked cardiovascular health as the first or second most important benefit, 40% of males

ranked prostate health as the first or second most important benefit, and approximately 18% of males did so for

erectile dysfunction. (CX0136 at 0002, 07-08; CX0453 at 0004).

3. Reibstein Survey

1344. The Reibstein Survey was conducted on behalf of POM Wonderful in connection with this litigation, by an

independent market research company, Horizon Consumer Science (“HCS”) under the direction of Dr. David J.

Reibstein. (PX0223 (Reibstein Expert Report at 0001, 0003); F. 266-275).

1345. HCS maintains an online panel of over one million subjects. From this population, a stratified sample of

2,164 was drawn from the United States population. (PX0223 (Reibstein Expert Report at 0004)).

1346. The Reibstein Survey sought to reveal (i) a buyer's motivation for purchasing pomegranate juice; (ii) whether

having previously seen POM Juice advertisements in the normal sequence of viewing advertisements and not in

an artificial setting, the advertisements affected the buyer's motivations for buying pomegranate juice; and (iii)

whether the buyer's awareness of the legal issues around the case might have affected their motivation for buying

pomegranate juice. (PX0223 (Reibstein Expert Report at 0005); Reibstein, Tr. 2487; PX0356 (Reibstein Dep. at

11, 38-39, 51)).

1347. The Reibstein Survey was conducted in October 2010. (Reibstein, Tr. 2541).

1348. Dr. Reibstein's Survey did not address POMx or the purchase motivations of POMx purchasers, and Dr.

Reibstein did not undertake to extrapolate the results of his survey to POMx purchasers. (Reibstein, Tr. 2565-66).

*162 1349. To qualify for the Reibstein Survey, respondents had to meet the following criteria: (i) purchased

pomegranate juice in the six months prior to the survey; (ii) had not completed any online survey within the

3 months prior to the survey for any beverage products; (iii) did not work in any of the following industries:
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advertising, public relations, beverages, marketing or market research; and (iv) was over 18 years old. This was

accomplished through a series of screening questions. (PX0223 (Reibstein Expert Report at 0004); PX0237 at

0001-02; PX0356 (Reibstein, Dep. at 50-51, 57-58)).

1350. Of the 2,164 panelists that completed the online Reibstein Survey, 750 of them met the qualification criteria,

and actually completed the survey. (PX0223 (Reibstein Expert Report at 0004)).

1351. The Reibstein Survey surveyed two groups, 406 respondents who purchased POM Juice in the past six

months (“POM Juice consumers”) and 344 respondents who purchased brands of pomegranate juice other than

POM in the past six months. (PX0223 (Reibstein Expert Report at 0004); Reibstein, Tr. 2493-94).

1352. The Reibstein Survey employed two types of controls. The first control was to draw a sample of nonPOM Juice buyers and ask them the same questions as the POM Juice buyers to see if these buyers had different

motivations for purchasing pomegranate juice. The second control was to compare the responses of people who

had seen POM advertisements against those who had not seen any POM advertisements. (PX0223 (Reibstein

Expert Report at 0004-05); Reibstein, Tr. 2488-89, 2493; PX0356 (Reibstein, Dep. at 73-74)).

1353. For the sample of 406 POM Juice consumers, the Reibstein Survey asked three primary open-ended

questions in Questions E through G, set forth below in F. 1354-1356. (PX0223 (Reibstein Expert Report at 0005)).

1354. Question E asked “Why did you purchase POM Wonderful 100% Pomegranate Juice? Please include as

many specific details.” (PX0237 at 0002 (italics in original); PX0223 (Reibstein Expert Report at 0006)).

1355. Question F asked “Would you consider purchasing POM Wonderful 100% Pomegranate Juice again?

(SELECT ONE ONLY)

1. Yes a. Why? Please include as many specific details as to why you would?

2. No a. Why not? Please include as many specific details as to why you would not?

3. Don't know.”

(PX0237 at 0002 (emphases in original); PX0223 (Reibstein Expert Report at 0007)).

1356. Question G asked “Would you recommend POM Wonderful 100% Pomegranate Juice to a friend?

(SELECT ONE ONLY)

1. Yes a. Why? Please include as many specific details as to why you would?

2. No a. Why not? Please include as many specific details as to why you would not?

3. Don't know.”

(PX0237 at 0002 (emphases in original); PX0223 (Reibstein Expert Report at 0008)).
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1357. For the 344 non-POM Juice pomegranate juice consumers, the Reibstein Survey asked three primary openended questions in Questions H through J, set forth below in F. 1358-1360. (PX0223 (Reibstein Expert Report

at 0005)).

*163 1358. Question H asked “You indicated that you have purchased pomegranate juice. Please include as

many specific details as to why you purchased it. Please be as detailed as possible.” (PX0237 at 0002 (emphases

in original); PX0223 (Reibstein Expert Report at 0006)).

1359. Question I asked “Would you consider purchasing pomegranate juice again?

(SELECT ONE ONLY)

1. Yes a. Why? Please include as many specific details as to why you would again?

2. No. a. Why not? Please include as many specific details as to why you would not again?

3. Don't know.”

(PX0237 at 0003 (emphases in original)).

1360. Question J asked “Would you recommend pomegranate juice to a friend?

(SELECT ONE ONLY)

1. Yes a. Why? Please include as many specific details as to why you would?

2. No. a. Why not? Please include as many specific details as to why you would not?

3. Don't know.”

(PX0237 at 0003 (emphases in original)).

1361. A summary of the results of the responses to Questions E-J was set forth by Dr. Reibstein in Figure 5 in

his expert report. Figure 5 is set forth below:

Question Percentage of POM Wonderful

Juice Buyers whose response

mentions a specific disease

reference n=406

Percentage of Pomegranate

Juice Buyers whose response

mentions a specific disease

reference n=344

E/H

(Why did you purchase?) 1.0% (4/406) .9% (3/344)

F/I

(Why would you purchase/not

purchase again?)

.5% (2/406) 0% (0/344)
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G/J

(Why would/would not

recommend?)

.3% (1/406) .9% (3/344)

NET 1.48% (6/406) 1.74% (6/344)

*164 (PX0223 (Reibstien Expert Report at 0020)).

1362. The “specific disease” references, as reported by respondents to the Reibstein Survey (F. 1361) included:

heart disease, getting rid of plaque, cancer, urinary tract infections, bowel movements, diabetes, kidney stones,

and arthritis pain. (PX0223 (Reibstein Expert Report at 0011-12)).

1363. The above findings (F. 1361-1362) reflect 12 unique survey respondents, because one participant responded

to both Question E and Question F with a disease reference. This respondent is counted only once in the “net”

results. (PX0223 (Reibstein Expert Report at 0011, 0020 n.1-6)).

1364. Questions E through J of the Reibstein Survey were in open-ended format, to reduce any biasing of the

survey respondents. (PX0223 (Reibstein Expert Report at 0005); PX0356 (Reibstein Dep. at 84-85)).

1365. In response to questions E and H of the Reibstein Survey, respectively, 35.2% of POM Juice purchasers

stated that they purchased or would repurchase POM Juice because it was “healthy” and 46.8% stated that they

would recommend it to a friend because it was “healthy.” In addition, 43.6% of POM Juice purchasers stated they

purchased because of the taste, and 74% stated they would repurchase because of the taste. (PX0223 (Reibstein

Expert Report at 0006-07)).

1366. Question K asked respondents: “Have you ever seen a POM Wonderful 100% Pomegranate Juice

advertisement?

(SELECT ONE ONLY)

1. Yes a. Please include as many specific details as to what you remember about the ad. Please be as detailed

as possible.

2. No

3. Don't know.”

(PX0237 at 0003 (emphases in original); PX0223 (Reibstein Expert Report at 0016); Reibstein, Tr. 2507, 2567).

1367. In response to Question K of the Reibstein Survey, 39.6% of people (297 out of 750) who consumed

pomegranate juice in the prior six months had seen a POM advertisement. (PX0223 (Reibstein Expert Report at

0009, 0016); PX0233 at 0028; Reibstein, Tr. 2536).

1368. In response to Question K of the Reibstein Survey, while 20% of the respondents reported “healthy,” none

of the respondents who saw a POM advertisement responded that they remember the advertisement making a

specific disease claim. Other common details reported by POM Juice purchasers were bottle appearance (22.4%);

people or objects in the advertisement (20.6%); and “don't know/no response” ‘2820%). (PX0223 (Reibstein

Expert Report at 0009); PX0233 at 0029).
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1369. In the Reibstein Survey, among the 12 unique respondents out of 750 total respondents, including non-POM

Juice buyers, who mentioned a specific disease as a reason for purchasing or recommending pomegranate juice,

4 reported having seen a POM advertisement at some point and 8 reported not ever having seen an advertisement.

(PX0223 (Reibstein Expert Report 0009, 0016-19)).

1370. Based on the Reibstein Survey findings, Dr. Reibstein, expressed the opinion that POM advertisements had

no impact on buyers' purchase motivations. (PX0223 (Reibstein Expert Report at 0020)).

*165 1371. Dr. Reibstein did not expose consumers to the Challenged Advertisements. (Reibstein, Tr. 2494).

1372. Based on the Reibstein Survey results, Dr. Reibstein, expressed the opinion that there is a very small

percentage of people that bought, would buy again, or would recommend POM Juice to a friend because they

believe that it cures or prevents a specific disease. (PX0223 (Reibstein Expert Report at 0020)).

1373. In rebutting the opinions of Dr. Reibstein, Dr. Mazis opined that the Reibstein Survey did not employ a

valid measure of materiality of the challenged claims in this case because the survey was a general assessment

of consumer motivations but did not assess whether any one of the challenged claims in the complaint would

be important in the decision to purchase or to use POM Juice. According to Dr. Mazis, what a consumer might

identify as a motivation for purchasing a product is not the same thing as assessing whether, if a consumer knew

of a claim, that claim would be important in his or her decision to purchase the product. (CX1297 (Mazis Expert

Report at 0008); Mazis, Tr. 2673).

1374. According to Dr. Mazis, in order to do a survey on materiality, “you don't have to show them the ad, but

you have to give them a statement about what the claim was and you have to ask them how important they think

that claim would be in their potential purchase decision.” (Mazis, Tr. 2728).

1375. Dr. Mazis further opined that Dr. Reibstein's methodology was flawed because he asked only open-ended

questions but did not follow-up with questions probing further what the respondents meant when referring to POM

Juice being “healthy” or having “health benefits” as their motivation for purchasing. According to Dr. Mazis, the

Reibstein Survey should have explored what survey respondents meant by their “healthy” response and whether

there were specific reasons or benefits that underlay “healthy” responses. (Mazis, Tr. 2756-57, 2707-09; PX0296

(Mazis Expert Report at 0009-10)).

1376. Dr. Mazis agreed that open-ended questions make it “significantly less likely that the respondents will be

led into giving a particular answer.” (Mazis, Tr. 2732).

1377. Dr. Mazis expressed the opinion that “the impact of advertising on beliefs about a product is not an

appropriate measure of materiality or ad claim communication.” (CX1297 (Mazis Expert Report at 0009)).

K. Remedy

1. Roll Global and POM entities

1378. Roll Global (“Roll”) is an approximately $2 billion corporation that includes under its umbrella the

companies Teleflora, Fiji Water, Paramount Farms (which sells Wonderful Pistachios and Wonderful Almonds),

Paramount Citrus (which sells Cuties), Justin Vineyards and Winery, and Suterra. (JX0003 ¶ B.3; S. Resnick, Tr.

1629-30; Perdigao, Tr. 593-94).
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1379. POM manufactures, advertises, and sells other products containing pomegranate, including various POM

Juice blends, Lite POM Juice, POMx bars, POMx iced tea and iced coffee, and a POMx sports recovery beverage.

(JX0003 ¶ B.8).

*166 1380. POM is headquartered in the same building as Roll, in many cases with employees of both companies

occupying the same floor. For example, Mr. Perdigao, the president of Roll's in-house advertising agency, Fire

Station and Roll's Corporate Communications department (F. 134, 138), and Ms. Leow, Fire Station's Creative

Director, are located on the same floor as the offices of Mrs. Resnick, Mr. Resnick, and Mr. Tupper, among other

POM employees. (Tupper, Tr. 888; Leow, Tr. 418; PX0277 at 0002-03).

1381. Mrs. Resnick describes Roll as “the umbrella company for all of our businesses” and others that work for

Respondents describe Roll similarly and consider POM to be part of Roll. (CX0001 at 00011; Posell, Tr. 298,

305; Tupper, Tr. 894; Perdigao, Tr. 593).

1382. Mr. and Mrs. Resnick each maintain a business address at 11444 West Olympic Blvd., 10th Floor, Los

Angeles, CA 90064, which is also the business address for POM and Roll. (PX0277 at 0002-03; see also PX0276

at 0002).

1383. Mrs. Resnick does not have a specific corporate title at POM. (L. Resnick, Tr. 287-88; CX1359 (L. Resnick,

Dep. at 37)).

1384. Although Roll's affiliated companies' pay Roll for certain provided services, including advertising (F.

13-14), not all expenses, such as advertising and marketing services, provided to POM were reimbursed. Roll has

provided various services over the years to POM relating to POM Juice, POMx Pills, and POMx Liquid “with

some portion charged back to POM ....” (CX1383 at 0014; CX1357 (Kuyoomjian, Dep. at 235)). For example,

the former Vice President of Corporate Communications at Roll testified she was not required to keep track of

her time based on whether she was working on a POM project or a project for another Roll company. (Posell,

Tr. 325). In addition, Roll provides risk management, human resources, consulting, and travel services to POM

without any reimbursement. (CX1354 (Bryant, Dep. at 41-42, 48-50, 55-64)).

1385. When Fire Station acts as Roll's in-house advertising agency, Fire Station bills POM and other Roll entities

separately, and each client pays for advertising and marketing expenses incurred. (CX1376 (S. Resnick, Ocean

Spray Dep. at 24-25); L. Resnick, Tr. 88-89; CX1359 (L. Resnick, Dep. at 26); Perdigao Tr. 616-17).

1386. The Resnicks have had ultimate say over all business functions of Roll and POM. They have set policy and

supervised the senior executives of both companies, disregarding corporate formalities. For example, Mrs. Resnick

has had complete oversight over POM's business, despite lacking any formal position with the company. (CX1368

at 0002-03 (L. Resnick, Welch Dep. at 8-9); CX1362 at 0012 (L. Resnick, Coke Dep. at 45-46); CX1374 (Tupper,

Ocean Spray Dep. at 18-19); S. Resnick, Tr. 1631 (stating that Mrs. Resnick is very involved in setting POM's

marketing and advertising budget); L. Resnick, Tr. 184 (stating that she has interviewed candidates for the chief

marketing officer or other senior vice president positions at POM); JX0001 ¶ 18 (showing overlapping officers

between POM and Roll); Posell, Tr. 321, 325 (stating that while Vice President of Corporate Communications,

Ms. Posell reported to Mr. Tupper and Mrs. Resnick)).

*167 1387. For accounting purposes, Roll and its affiliated companies, including POM, were represented as being

under common control or ownership and have been included together on consolidated financial and tax statements.

(CX1354 (Bryant, Dep. at 23, 27, 52-53), in camera; see also CX1355 (Hemmati, Dep. at 52-54) (stating that Roll

provided information about the Resnick Trust's payments for medical research to POM); CX1276 at 0003).
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1388. POM's Consumer Affairs representative would typically respond to consumer complaints; however, “if

necessary, [they] might get escalated” to others at POM or Roll, such as Roll's Corporate Communications, which

may respond directly to the consumer. (CX1357 (Kuyoomjian, Dep. at 204-10)

1389. Roll also interacts with POM for the purposes of joint cash management, as noted by Roll's Chief Financial

Officer, Robert Bryant, who stated that Roll “pool[s] together the cash from each one of [its] operating companies

and will invest that cash ... overnight for purposes of investments ... [o]r if [Roll has] debt outstanding on [its]

working capital lines, then [Roll] will use that cash to pay down those working capital ... lines.” (CX1354 (Bryant,

Dep. at 67)).

1390. POM's medical research program was sponsored and funded by various Resnick entities (e.g., Roll, POM,

and the Resnick Trust). (CX1118 at 0001; CX0604 at 0022 (stating that “Roll Int'l will reimburse Technion

[Institute] directly,” even though POM was listed as the research sponsor); CX0628 at 0001 (describing a study

on pomegranate juice as the “Roll Beverage Study”); see also F. 1391).

2. The Resnicks

1391. The Stewart and Lynda Resnick Revocable Trust entered into contracts to fund research; however, regardless

of which Resnick-controlled organization has paid for pomegranate research, the money ultimately comes from

the Resnicks. (CX0610; S. Resnick, Tr. 1657, 1675-76, 1722-23; CX1363 at 0016 (S. Resnick, Coke Dep. at 61)

(whether a study is sponsored by Roll or POM, “[t]he money comes out of the same pockets”); see also CX1376

(S. Resnick, Ocean Spray Dep. at 229-30 (the $34 million referenced in a POM advertisement is ultimately “our

money, however it comes”)); L. Resnick, Tr. 198-99).

1392. Mr. Resnick has been directly involved in the development of POM's scientific research program by

engaging and communicating with scientific consultants, participating in scientific advisory board meetings, and

convening company-sponsored research summits. (CX1360 (S. Resnick, Dep. at 85, 110-12); Tupper, Tr. 1027-28;

Liker, Tr. 1880, 1889, 1891; CX0589).

1393. With regard to the medical research budget, Mr. Resnick reviews and approves the POM research budget

annually, and when necessary if any changes occur during the year. (CX1376 (S. Resnick, Ocean Spray Dep. at

227)).

1394. Mr. Resnick reviews the results of the scientific research he sponsors, and has seen the results of all the

important tests and also some of the draft manuscripts before they were published. (S. Resnick, Tr. 1656-57).

*168 1395. Mr. Resnick meets with POM and its scientific advisors about POM-sponsored research ten to

twelve times a year “officially” and three to four additional times to review what has been learned and where the

company's research may go. (CX1376 (S. Resnick, Ocean Spray Dep. at 223-24).

1396. Mrs. Resnick participated in POM's business on almost a daily basis in the company's early years, and on a

weekly or biweekly basis thereafter and through 2010. (L. Resnick, Tr. 93, 157-58; see also CX1375 (L. Resnick,

Tropicana Dep. at 19-22, 78); CX1359 (L. Resnick, Dep. at 108)).

1397. If there were disputes or issues to resolve regarding advertising decisions, the final authority was either Mr.

or Mrs. Resnick. As the overseer of all branding and marketing, Mrs. Resnick had the “final word” on advertising

content and concepts. (CX1365 (Perdigao, Coke Dep. at 36-37)); CX1368 at 0003 (L. Resnick, Welch's Dep. at

9); L. Resnick, Tr. 93; CX1347 (Glovsky, Dep. at 36); CX1357 (Kuyoomjian, Dep. at 84)).
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1398. Mrs. Resnick has participated in the hiring and firing of heads of marketing at POM. (L. Resnick, Tr. 183-84,

227-28).

1399. Mrs. Resnick has had a principal role in approving advertising content since POM's inception. For example,

Mrs. Resnick requested that copies of all advertising campaigns be submitted to her for final approval including

the headlines used in POM's advertisements. (CX1368 at 0003 (L. Resnick, Welch Dep. at 9); see also CX1357

(Kuyoomjian, Dep. at 56-57, 77, 127); CX1346 (Rushton, Dep. at 42 (approval of website designs)); CX0147).

1400. At LRR Meetings (F. 141) and during other interactions with POM Marketing and Fire Station, Mrs. Resnick

would approve a general direction for POM's advertising and also approved the lion's share of POM's advertising

concepts. (see F. 143).

1401. Mrs. Resnick was “very involved” in developing the POMx brochure, identified as CX1426, Exhibit I

“Antioxidant Superpill” package insert, when it was first produced. (L. Resnick, Tr. 246; see F. 328-342).

1402. Mrs. Resnick was involved in the approval of the print advertisement identified as CX0029 (“10 OUT OF

10 PEOPLE DON'T WANT TO DIE”) (CX0471 at 0007-08; L. Resnick, Tr. 158; CX0029; see F. 299-305).

1403. Mrs. Resnick approved the headline for the POMx print advertisement headlined “The Only Antioxidant

Supplement Rated X.” (L. Resnick, Tr. 266; see CX0351 and CX0355; see F. 321-327)).

1404. Mrs. Resnick approved the print advertisement identified as CX0031 (“Floss your arteries” print

advertisement); CX0471 at 0010; L. Resnick, Tr. 158-59; CX0031; see F. 440-448).

3. Matthew Tupper

1405. Mr. Tupper has never had any ownership interest in POM Wonderful and has no expectation of ever having

such an interest. (CX1353 (Tupper, Dep. at 14-15); Tupper, Tr. 2973).

1406. Mr. Tupper had no more authority at POM than was delegated to him by Mr. Resnick. Mr. Resnick delegated

to Mr. Tupper the authority to decide which advertisements should run. (S. Resnick, Tr. 1870).

*169 1407. When Mrs. Resnick reduced her day-to-day involvement in POM's business beginning in 2007, Mrs.

Resnick felt confident that Mr. Tupper would be able to take care of the marketing aspects of the business, as she

had previously done. (L. Resnick, Tr. 229).

1408. Mr. Tupper reviewed work on each of POM's large advertising campaigns at the concept stage, before they

were shown to Mrs. Resnick. (Leow, Tr. 459-60).

1409. With respect to health benefit advertising, Mr. Tupper was the “connecting piece” or “liaison” between the

marketing vision and the communication of the science. (Tupper, Tr. 2975-76).

1410. Mr. Tupper led meetings to review advertising copy from a scientific perspective prior to its dissemination.

(Dreher, Tr. 530).
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1411. Mr. Tupper was engaged in the medical research aspect of POM's business from the time he first joined

POM full-time in 2003. Beginning in late 2006 or early in 2007, he became more engaged as the “connecting

piece” between research and marketing. (Tupper, Tr. 2975-77; see F. 1409).

1412. As POM's president, Mr. Tupper attended most of the marketing review meetings with Mrs. Resnick,

which included discussions of POM's scientific research. (Tupper, Tr. 929-30; CX1351 (McLaws, Dep. at 33-34);

CX1347 (Glovsky, Dep. at 149-50)).

1413. Mr. Tupper was significantly involved in the research aspects of POM's business, the internal decisionmaking as to what research to fund, and overseeing for POM the clinical trials on POM's products that were

conducted by research institutions. (Tupper, Tr. 895-96, 906; see also CX0770; CX0779; CX0800; CX0919;

CX0920).

1414. POM's former Senior Vice President of Marketing, Ms. Diane Kuyoomjian, relied on her conversations

with Mr. Tupper to understand the content in POM's advertising regarding the relationship between POM

advertisements and the scientific support for these advertisements. She relied on Mr. Tupper to be the “arbiter”

of whether people felt POM's advertising was accurate. (CX1378 (Kuyoomjian, Ocean Spray Dep. at 71-72)).

1415. Ms. Kuyoomjian, “would never do something [Mr. Tupper] wasn't involved in. He was [her] boss.” (CX1357

(Kuyoomjian, Dep. at 51)).

1416. As one of the senior leaders at POM, Mr. Tupper organized meetings to review advertising copy from a

scientific perspective. (Dreher, Tr. 530).

1417. Mr. Tupper reviewed and gave direction to POM's marketing staff on parts or elements of creative briefs.

(Tupper, Tr. 924).

1418. According to POM's former Senior Vice President of Marketing, Ms. Kuyoomjian, Mr. Tupper was the

primary person from whom she received information on POM's medical research, including information that

would appear in consumer advertising copy, and Mr. Tupper in general would provide input as to how to describe

the medical research used in advertisement copy. (CX1357 (Kuyoomjian, Dep. at 164-66); see also CX0906 at

0001-02 (providing guidance on what types of studies should be used in newsletters and websites)).

*170 1419. Mr. Tupper participated in meetings in which Fire Station and POM personnel presented and

reviewed advertising concepts and advertising. (L. Resnick, Tr. 91-92; Tupper, Tr. 929).

1420. Mr. Tupper reviewed advertising copy (including headlines), made changes to copy, and, depending on

the project, had final say over POM advertising content and which advertisements should or should not run. (L.

Resnick, Tr. 87; Leow, Tr. 423-24, 464-66; Tupper, Tr. 925-27; S. Resnick, Tr. 1870; CX1357 (Kuyoomjian,

Dep. at 141-42)).

1421. Sometimes, Mr. Tupper would provide the specific words to use when presenting medical research facts,

and in other instances, POM Marketing or Fire Station employees would “take a stab at writing [this information]

and send it to [Mr. Tupper] to approve.” (CX1357 (Kuyoomjian, Dep. at 169-70)).

1422. On average, Mr. Tupper has interacted with Mr. Perdigao, head of Fire Station creative agency, once a

week. (Perdigao, Tr. 613).
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1423. During periods when the position of head of marketing at POM was vacant, Mr. Tupper would step

in to some extent, and if the subject matter required a high level person, Mr. Tupper would take the lead in

communicating with Fire Station. (L. Resnick, Tr. 185; Perdigao, Tr. 611-12).

1424. Mr. Tupper had direct contact with research scientists who were working on POM's products, including

substantive discussions of the underlying science. (Tupper, Tr. 899, 914).

1425. Mr. Tupper worked with Dr. Dreher in preparing summaries of POM's research portfolio. Mr. Tupper

offered the business perspective by drafting the “where do we go from here” sections of POM's medical research

summaries. He also edited the research summaries. (Dreher, Tr. 555-56, 558; CX1015 at 0001; CX1029).

1426. Mr. Tupper, along with Mr. Resnick, would meet on occasion with Dr. Liker, POM's Medical Director, to

communicate the scientific research areas that POM was interested in exploring. (Liker, Tr. 1880).

1427. Mr. Tupper's responsibilities included keeping up to date on the status of medical research on POM's

products, as well as reviewing the unpublished and published data that resulted from studies on POM's products.

(Tupper, Tr. 913-14, 941; S. Resnick, Tr. 1720-21).

1428. Mr. Tupper, along with Mr. Resnick, participated in meetings with POM's scientific advisors to review

research summaries, discuss research results, and come up with future plans for additional research. (Liker, Tr.

1889, 1915, 1925; Dreher, Tr. 555-56). Some of these scientific research meetings also included POM's scientific

director at the time (either Risa Schulman, Dr. Dreher, or Dr. Gillespie), Dr. Liker, Dr. Heber, or Dr. David Kessler

(“Dr. Kessler”), an advisor to POM. (Liker, Tr. 1889; Heber, Tr. 2068, 2072; Heber, Tr. 2072; S. Resnick, Tr.

1859).

1429. Mr. Tupper participated in regular research summits, which were meetings with scientists that helped POM

interpret the results of scientific research and facilitated discussions about future research. (Liker, Tr. 1890-92).

*171 1430. Mr. Tupper reviewed press releases prior to issuance. (Posell, Tr. 368; CX0062; CX0127).

1431. Mr. Tupper participated in drafting the Time magazine cover wraps found herein to have made the claims

alleged in the Complaint (see F. 308-320, 581; CX1378 (Kuyoomjian, Ocean Spray Dep. at 88-90)).

III. ANALYSIS

A. Burden of Proof

The parties' burdens of proof are governed by Rule 3.43(a) of the Federal Trade Commission's Rules of Practice,

Section 556(d) of the Administrative Procedure Act (“APA”), and case law. Pursuant to Commission Rule 3.43(a),

“[c]ounsel representing the Commission ... shall have the burden of proof, but the proponent of any factual

proposition shall be required to sustain the burden of proof with respect thereto.” 16 C.F.R. § 3.43(a). Under the

APA, “[e]xcept as otherwise provided by statute, the proponent of a rule or order has the burden of proof.” 5

U.S.C. § 556(d).

It is well established that the preponderance of the evidence standard governs Federal Trade Commission (“FTC”)

enforcement actions. In re Telebrands Corp., No. 9313, 140 F.T.C. 278, 426, 2004 FTC LEXIS 154, at *76 (Sept.

15, 2004) (Initial Decision), aff'd, 140 F.T.C. 278, 2005 FTC LEXIS 178 (Sept. 19, 2005), aff'd, 457 F.3d 354 (4th

Cir. 2006); In re Automotive Breakthrough Sciences, Inc., No. 9275, 1998 FTC LEXIS 112, at *38 n.45 (Sept.
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9, 1998) (holding that each finding must be “supported by a preponderance of the evidence in the record”); In re

Adventist Health System/West, No. 9234, 117 F.T.C. 224, 1994 FTC LEXIS 54, at *28 (Apr. 1, 1994) (“[e]ach

element of the case must be established by a preponderance of the evidence”); In re Bristol-Meyers Co., No. 8917,

102 F.T.C. 21, 1983 FTC LEXIS 64, at *143 (Sept. 28, 1979) (Initial Decision) (stating that complaint counsel has

“the burden of proving by a preponderance of credible evidence that the challenged advertising claims have not

been established or did not have a reasonable basis”), aff'd, 1983 FTC LEXIS 21, at *242 (July 5, 1983), aff'd, 738

F.2d 554 (2d Cir. 1984). See also Steadman v. SEC, 450 U.S. 91, 102 (1981) (holding that the APA establishes

preponderance of the evidence standard of proof for formal administrative adjudicatory proceedings).

The Complaint in this case alleges that Respondents disseminated advertising and promotional materials

representing that the consumption of eight ounces of POM Juice, one POMx Pill, or one teaspoon of POMx

Liquid (the “POM Products”) daily “prevents or reduces the risk of” or “treats” heart disease, prostate cancer

or erectile dysfunction. Complaint ¶¶ 9, 10, 19. The Complaint further alleges that Respondents represented that

they possessed and relied upon, but in fact did not possess or rely upon, a reasonable basis substantiating such

claims, and thus, Respondents' representations were false or misleading. Complaint ¶¶ 19-21. In addition, the

Complaint alleges that Respondents have disseminated advertising and promotional materials representing that

“clinical studies, research, and/or trials prove” that consuming the POM Products “prevents or reduces the risk

of” or “treats” heart disease, prostate cancer or erectile dysfunction, Complaint ¶¶ 9, 10, 12, 14, 16, but that these

representations were false or misleading because clinical studies, research, and/or trials do not in fact prove that

consuming the POM Products, “prevents or reduces the risk of” or “treats” heart disease, prostate cancer or erectile

dysfunction. Complaint ¶¶ 13, 15, 17, 18. Complaint Counsel has the burden of proving each of the foregoing

factual issues by a preponderance of credible evidence. In re Bristol-Myers Co., 1983 FTC LEXIS 64, at *143-44.

See also FTC v. QT, Inc., 448 F. Supp. 2d 908, 959 (N.D. Ill. 2006), aff'd, 512 F.3d 858 (7th Cir. 2008).

B. Jurisdiction

*172 Section 5 of the Federal Trade Commission Act (“FTC Act”) grants the Federal Trade Commission the

authority to “prevent unfair or deceptive acts or practices in or affecting commerce” by “persons, partnerships, or

corporations.” 15 U.S.C. § 45(a)(1)-(2) (2012). Section 4 of the FTC Act defines “corporation,” in part, as “any

company, trust, so-called Massachusetts trust, or association, incorporated or unincorporated, which is organized

to carry on business for its own profit or that of its members, and has shares of capital or capital stock or certificates

of interest ....” 15 U.S.C. § 44.

POM Wonderful (“POM Wonderful” or “POM”) is a limited liability company. F. 1. Roll International

Corporation, which was reorganized at the end of 2010 and is currently known as Roll Global (“Roll”), is a separate

corporation. F. 7-8. POM Wonderful is one of several separate operating businesses under Roll's ownership

umbrella. F. 11. Mr. Stewart Resnick (“Mr. Resnick”) and Mrs. Lynda Resnick (“Mrs. Resnick”) are the sole

owners of Roll and its affiliated companies, including POM Wonderful. F. 12. Mr. Resnick is the Chairman and

President of Roll and the Chairman and Chief Executive Officer of POM Wonderful. F. 19-21. Mrs. Resnick is

Vice Chairman of Roll. F. 27-28. She is the chief marketing person at POM, with responsibilities for marketing,

branding, public relations, and product development. F. 29-31. Mr. Matthew Tupper was the President of POM

and managed the day-to-day operations of POM Wonderful, including the POM marketing team, prior to his

retirement in 2011. F. 37-38, 40, 44. Thus, POM Wonderful and Roll Global are partnerships or corporations and

Mr. and Mrs. Resnick and Mr. Tupper are individuals over which the FTC has jurisdiction.

POM Wonderful is currently in the business of selling fresh pomegranates and pomegranate-related products,

including 100% pomegranate juice (“POM Juice”) and pomegranate extract products known as POMx Pills and

POMx Liquid (“POMx”). F. 6. Respondents began selling POM Juice in 2002. F. 5, 95. POM Juice is sold in

supermarkets nationally and is a major seller in the premium juice category. F. 95. POM's U.S. Sales of 100%
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POM Juice, from September 2002 to November 2010, totaled approximately $247,739,776. F. 96. Respondents

admit that “[t]he acts and practices of respondents alleged in this complaint have been in or affecting commerce, as

‘commerce’ is defined in Section 4 of the Federal Trade Commission Act.” Answer ¶ 8. In addition, Respondents

promoted the POM Products through various methods, including print advertisements in magazines, freestanding

inserts in newspapers, out of home media such as billboards and bus shelters, posters in health clubs and doctors'

offices, Internet websites, online banner advertisements, press releases, and television advertisements. F. 171. The

acts and practices charged in the Complaint in this matter are in or affecting commerce within the meaning of

the FTC Act, as amended. 15 U.S.C. § 41 et seq. Accordingly, the Commission has jurisdiction over the conduct

challenged in the Complaint, pursuant to Sections 4 and 5 of the FTC Act. 15 U.S.C. §§ 44, 45.

C. Scope of Challenged Advertisements in this Case

1. “Advertisements”

*173 The Complaint charges Respondents with violating Sections 5 and 12 of the FTC Act. Complaint ¶ 22.

Section 5(a) of the FTC Act provides that “unfair or deceptive acts or practices in or affecting commerce are hereby

declared unlawful.” 15 U.S.C. § 45(a)(1). Section 12 of the FTC Act prohibits the dissemination of “any false

advertisement” in order to induce the purchase of “food, drugs, devices, services, or cosmetics.” 15 U.S.C. § 52(a)

(2). For the purposes of Section 12, “false advertisement” is defined as “an advertisement, other than labeling,

which is misleading in a material respect[.]” 15 U.S.C. § 55(a).

The interrelation between Section 5(a) and Section 12 of the FTC Act was recently described by the Court of

Appeals for the First Circuit as follows:

[T]he FTC statute ... provides that both “unfair or deceptive acts or practices in or affecting commerce” (15 U.S.C.

§ 45(a)(1)) and “disseminat [ing], or caus[ing] to be disseminated, any false advertisement ... in or having an effect

upon commerce” (15 U.S.C. § 52(a)) are “unlawful.” 15 U.S.C. § 55 defines the term “false advertisement” as

“an advertisement, other than labeling, which is misleading in a material respect ....” Given the strong similarity

between the terms “deceptive” and “misleading,” it is no surprise that sections 45 and 52 are sometimes applied

in tandem as the basis for an FTC action against an alleged false advertiser; indeed, such a tandem reading is

expressly allowed by 15 U.S.C. § 52(b).

FTC v. Direct Marketing Concepts, Inc., 624 F.3d 1, 7-8 (1st Cir. 2010).

Complaint Counsel in this case has challenged 43 items, which Complaint Counsel describes as “Respondents' ads

and promotional pieces,” as violating Sections 5 and 12 of the FTC Act. CCB at 19; CCB Appendix A, Tables 1 and

2 (hereafter, “CCB Appendix A”). Specifically, Complaint Counsel challenges print advertisements, newsletters,

website advertising, and “public relations” promotional pieces, including press releases and press interviews.

CCB Appendix A; see also CCB at 13. Complaint Counsel asserts that all of the challenged promotional pieces

constitute “advertisements” within the scope of Section 12 of the FTC Act, 15 U.S.C. § 52, and deceptive acts or

practices within the scope of Section 5 of the FTC Act, 15 U.S.C. § 45. CCB at 14.

*174 Respondents contend that the following four challenged items do not constitute “advertisements” in

violation of Sections 5 and 12 of the FTC Act: 5

1. Mrs. Resnick's November 2008 television appearance on The Martha Stewart Show, during which she shared

personal recipes for a POMtini cocktail and Thanksgiving stuffing, (CX1426 (Compl. Ex. E-6));

2. Mrs. Resnick's February 2009 television appearance on The Early Show, during which she shared some

marketing ideas for POM and FIJI Water, (CX0472 at 0003);
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3. an interview of Mrs. Resnick in Newsweek magazine, dated March 20, 2009, discussing the economy, her

business acumen, and promoting the sale of her book, Rubies in the Orchard, (CX1426 (Compl. Ex. F)); and

4. a June 2008 television interview of Mr. Tupper on FOX Business discussing the newest “hot” wave in foods

— the pomegranate — and the pomegranate juice industry, (CX1426 (Compl. Ex. E-7)).

Respondents assert that these four interviews are not actionable under the FTC Act because they do not constitute

“advertising.” RB at 92. Complaint Counsel charges that these media appearances constitute “advertisements”

within the scope of Section 12, CCB at 14, and contends that neither Section 5 nor Section 12 limits the FTC's

reach to paid for advertising. CCRB at 44. Complaint Counsel further argues that the Commission's authority

to regulate advertising is circumscribed only by its statutory authority and the limits of the commercial speech

doctrine. CCRB at 44 (citing In re R.J. Reynolds Tobacco Co., No. 9206, 111 F.T.C. 539, 542 (Mar. 4, 1988)).

The term “advertisement” is not defined in the FTC Act. However, in R.J. Reynolds Tobacco, the Commission

made clear that it “understands[] [the term advertisement] to mean a notice or announcement that is publicly

published or broadcast and is paid-for.” R.J. Reynolds Tobacco Co., 1988 FTC LEXIS 9, at *20. Complaint

Counsel does not contend and has not pointed to any evidence to support a conclusion that Respondents paid

anyone for their participation in the interviews or to allow them to speak about their products. See CCFF 570-577.

Moreover, these media interviews were conducted by individuals working with The Martha Stewart Show, The

Early Show, Newsweek, and FOX Business — entities other than the Respondents — and were not sponsored by

Respondents. See F. 575-578. By contrast, the radio program that was found to constitute an “advertisement” in

Daniel Chapter One ran on a radio network founded and funded by respondents, was titled “Daniel Chapter One

HealthWatch,” and was co-hosted by the individual respondents who were responsible for its content. In re Daniel

Chapter One, No. 9329, 2009 FTC LEXIS 157, *21-22, 48, 163, 169-70 (Aug. 5, 2009) (Initial Decision), aff'd,

2009 FTC LEXIS 259 (Dec. 24, 2009). 6See also In re Witkower Press, Inc., 57 F.T.C. 145, 1960 FTC LEXIS

186, *157 (July 19, 1960) (finding “respondents' newspaper advertisements, book jackets and the television shows

sponsored by them unquestionably constitute commercial advertising”) (emphasis added).

*175 Complaint Counsel has cited no cases where the Commission charged a respondent with violating Section

12 of the FTC Act based on public statements that were not paid for or sponsored by the respondent. E.g., In re R.

J. Reynolds Tobacco Co., 1988 FTC LEXIS 9, *1 (“This case involves an advertisement, entitled ‘Of Cigarettes

and Science,’ allegedly disseminated by Reynolds in the course of its business of manufacturing, advertising and

selling cigarettes.”); FTC v. Nat'l Comm'n on Egg Nutrition, 517 F.2d 485, 487-88 (7th Cir. 1975) (“[P]ublished

and broadcast statements, in the form of paid advertisements, representing in substance that there is no scientific

evidence that eating eggs increases the risk of heart disease or a heart attack ... were advertisements within the

meaning of that term as used in the [FTC] Act, because they were representations concerning the qualities of a

product and promoting its purchase and use.”); Nat'l Comm'n on Egg Nutrition v. FTC, 570 F.2d 157, 159 (7th

Cir. 1977) (enforcing, in part, order imposed on industry association which “mounted an advertising and public

relations campaign to convey the message that eggs are harmless and are needed in human nutrition”).

The only case found involving statements made in a public speaking engagement, cited by Respondents and

addressed by Complaint Counsel, is FTC v. Koch, 206 F.2d 311 (6th Cir. 1953). The court there, without addressing

whether promotional materials must be paid for to constitute advertising, found that a challenged book, which

“set forth primarily matter of opinion,” did “not fall within the provisions of the statutes involved here.” Id. at

317. The court explained:
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We also think that if these provisions of the statutes were construed so as to prohibit dissemination of such

a book they would violate the First Amendment to the Constitution of the United States. It was not error for

the Commission to consider this book and to quote extracts from it as throwing light upon the existence or

non-existence of facts supporting the charge in the complaint, for the book was introduced by the respondents.

However, we hold that it is not an advertisement covered by Sections 5, 12, or 15(a). We make a similar conclusion

with reference to Dr. Koch's address before the College of Physicians and Surgeons of Quebec in 1939. If the

record contained only these two exhibits, the Commission would not have jurisdiction in this proceeding.

Id.

Complaint Counsel has offered no authority to support a conclusion that publicly disseminated information that

is not paid for or sponsored by Respondents constitutes “advertisements” within the scope of Section 12 of the

FTC Act. Under the Commission's precedent regarding the statutory term “advertisement,” the media appearances

and interviews by Respondents in this case do not constitute “advertisements” within the scope of Section 12

of the FTC Act because they were not paid for or sponsored by Respondents. Therefore, the issue of whether

the media interviews constitute constitutionally protected speech need not be, and is not, decided. Because the

following exhibits — CX1426 (Compl. Ex. E-6) (Mrs. Resnick's November 2008 television appearance on The

Martha Stewart Show); CX0472 at 0003 (Mrs. Resnick's February 2009 television appearance on The Early Show);

CX1426 (Compl. Ex. F) (interview of Mrs. Resnick in Newsweek magazine); and CX1426 (Compl. Ex. E-7)

(television interview of Mr. Tupper on FOX Business) — do not constitute “advertisements,” this Initial Decision

does not evaluate whether Respondents made any of the alleged claims in those exhibits. Moreover, the term,

“Challenged Advertisements,” as used herein, does not include these four media appearances and interviews.

2. “Food” or “drug”

*176 The FTC Act defines the words “food” and “drug” broadly for purposes of Section 12. 15 U.S.C. § 55(b),

(c) (defining “food” as, among other things, “articles used for food or drink for man,” and defining “drug” as,

among other things, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

in man”). Courts have repeatedly held that these definitions of “food” or “drug” cover dietary supplements. In

re Daniel Chapter One, 2009 FTC LEXIS 157, at *171-73 (Initial Decision) (citing FTC v. Natural Solution,

Inc., 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. 2007); FTC v. Nat'l Urological Group, 645 F. Supp. 2d

1167, 1190 (N.D. Ga. 2008); Direct Marketing, 569 F. Supp. 2d at 300-03). POM Juice is a juice derived from

pomegranate fruits. F. 57-58. POMx Pills and Liquid are extracts derived from the pomegranate. F. 67, 70-71,

89-90. Accordingly, each of the POM Products are a “food” or “drug” (F. 60, 61, 67, 70-71, 89-90) as defined

in Section 12 of the FTC Act.

D. Overview of Applicable Law

An “advertisement is deceptive under the [FTC] Act if it is likely to mislead consumers, acting reasonably under

the circumstances, in a material respect.” Kraft, Inc. v. FTC, 970 F.2d 311, 314 (7th Cir. 1992) (citing In re

Thompson Medical Co., No. 9149, 104 F.T.C. 648, 788, 1984 FTC LEXIS 6, at *311 (Nov. 23, 1984), aff'd, 791

F.2d 189 (D.C. Cir. 1986)); In re Cliffdale Assocs., No. 9156, 103 F.T.C. 110, 164-66, 1984 FTC LEXIS 71, at

*104 (Mar. 23, 1984)). The determination of whether Respondents disseminated false advertisements in violation

of the FTC Act requires a three-part inquiry: (1) whether Respondents disseminated advertisements conveying the

claims alleged in the Complaint; (2) whether those claims were false or misleading; and (3) whether those claims

are material to prospective consumers. Kraft, 970 F.2d at 314;FTC v. Pantron I Corp., 33 F.3d 1088, 1095 (9th

Cir. 1994); Direct Marketing, 569 F. Supp. 2d at 297. Each of these elements is addressed below.

E. Whether Respondents Disseminated Advertisements Conveying the Alleged Claims
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1. General principles

“The Commission will deem an advertisement to convey a claim if consumers, acting reasonably under the

circumstances, would interpret the advertisement to contain that message.” Thompson Medical, 104 F.T.C. at

788; Cliffdale Associates, Inc., 103 F.T.C. at 164-66; Federal Trade Commission Policy Statement on Deception,

appended to Cliffdale Associates, Inc., 103 F.T.C. 110, 1984 FTC LEXIS 71, at *176-77 (1984) (the “Deception

Statement”); In re Kraft, Inc., 114 F.T.C. 40, 1991 FTC LEXIS 38, at *10 (1991).

*177 Advertising claims may be conveyed either expressly or impliedly. Express claims directly state the

representation at issue. Kraft, 970 F.2d at 319 n.4;Thompson Medical, 104 F.T.C. at 788, 1984 FTC LEXIS 6, at

*311; Cliffdale, 1984 FTC LEXIS 71, at *108 (1984). Because the claim is stated unequivocally, the statement

itself establishes its meaning, and it is, therefore, reasonable to interpret such advertisement as making the alleged

claim. Thompson Medical, 104 F.T.C. at 788, 1984 FTC LEXIS 6, at *311-12. Implied claims are made in an

oblique or indirect way. Kraft, 970 F.2d at 319 n.4.

An interpretation of an advertisement may be reasonable even though it is not shared by a majority of consumers.

Kraft, 1991 FTC LEXIS 38, at *14; Deception Statement, 1984 FTC LEXIS 71, at *177 n.20. A reasonable

interpretation is one that would be shared by a “significant minority” of reasonable consumers. Id.; In re Novartis

Corporation, No. 9279, 127 F.T.C. 580, 1999 FTC LEXIS 63, at *22-23 (May 13, 1999); Kraft, 1991 FTC LEXIS

38, at *14; see also Telebrands Corp., 140 F.T.C. at 291 (“An ad is misleading if at least a significant minority

of reasonable consumers are likely to take away the misleading claim.”).

“[F]indings with respect to what representations are made in advertisements are factual. See, e.g., Thompson

Medical v. FTC, 791 F.2d 189, 197 (D.C. Cir. 1986) (quoting from the FTC's brief); AHP [American Home

Products], 695 F.2d [681,] 686 [(3rd Cir. 1982)]; Beneficial Corp. v. FTC, 542 F.2d 611, 617 (3d Cir. 1976).”

Removatron Int'l Corp. v. FTC, 884 F.2d 1489, 1496 (1st Cir. 1989). In the instant case, it has been found as a fact

that none of the Challenged Advertisements expressly (i.e., unequivocally and directly) states that “drinking eight

ounces of POM Juice daily” or “taking one POMx Pill daily,” or “taking one teaspoon of POMx Liquid daily” (1)

“treats,” “prevents,” or “reduces the risk” of “heart disease,” including by reducing arterial plaque, lowering blood

pressure, and/or improving blood flow to the heart, or that these effects are “clinically proven”; (2) “treats,”

“prevents,” or “reduces the risk” of “prostate cancer,” including by prolonging prostate-specific antigen doubling

time, or that these effects are “clinically proven”; or (3) “treats,” “prevents,” or “reduces the risk” of erectile

dysfunction, or that these effects are “clinically proven.” F. 586. Thus, the issue is whether any of the Challenged

Advertisements made the alleged claims implicitly; that is, whether a significant minority of consumers, acting

reasonably in the circumstances, would interpret any of the Challenged Advertisements to convey the claims

alleged in the Complaint. The methodology used in making this factual determination is further explained in below.

a. Facial analysis

*178 To determine whether an advertisement conveys an alleged claim, the first step is to examine the

advertisement itself (a “facial analysis”). Thompson Medical, 1984 FTC LEXIS 6, at *313; Cliffdale, 1984 FTC

LEXIS 71, at *108. A proper facial analysis requires “an evaluation of such factors as the entire document, the

juxtaposition of various phrases in the document, the nature of the claim, and the nature of the transaction.”

Deception Statement, 103 F.T.C. 110, 1984 FTC LEXIS 71, at *172. The advertisement must be viewed as a

whole “without emphasizing isolated words or phrases apart from their context.” Removatron, 884 F.2d at 1496

(quoting AHP), 695 F.2d at 687;see also FTC v. Sterling Drug, Inc., 317 F.2d 669, 674 (2d Cir. 1963) (“The entire

mosaic should be viewed rather than each tile separately.”). “But the Commission may not inject novel meanings

into ads and then strike them down as unsupported; ads must be judged by the impression they make on reasonable
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members of the public.” In re Bristol-Meyers Co., No. 8917, 102 F.T.C. 21, 1983 FTC LEXIS 64, *249 (July 5,

1983), aff'd, 738 F.2d 554 (2d Cir. 1984).

“If, after examining the interaction of all the different elements in the ad, the Commission can conclude with

confidence that an advertisement can reasonably be read to contain a particular claim, a facial analysis is sufficient

basis to conclude that the advertisement conveys the claim. See Kraft, 114 F.T.C. at 121; Thompson Medical, 104

F.T.C. at 789.” In re Stouffer Foods Corp, No. 9250, 118 F.T.C. 746, 1994 FTC LEXIS 196, at *9 (Sept. 26, 1994).

However, the alleged claim must be reasonably clear or conspicuous from the face of the advertisement. Kraft,

970 F.2d at 319 (holding that the Commission can rely on its own reasoned analysis to determine what claims,

including implied ones, are conveyed in a challenged advertisement “so long as those claims are reasonably clear

from the face of the advertisement”); accord Nat'l Urological Group, 645 F. Supp. 2d at 1189 (holding that facial

analysis is sufficient basis to find alleged claim was made if claims are “clear and conspicuous” or “apparent”

on the face of the advertisement); QT, Inc., 448 F. Supp. 2d at 958 (“Where implied claims are conspicuous and

reasonably clear from the face of the advertisements, extrinsic evidence is not required.”).

*179 If, after a facial analysis, it cannot be concluded with confidence that a particular advertisement can

reasonably be read to contain a particular implied message, “the Commission will not find the ad to have made the

claim unless extrinsic evidence allows the conclusion that such a reading of the ad is reasonable. Kraft, 114 F.T.C.

at 121; Thompson Medical, 104 F.T.C. at 789.” Stouffer, 1994 FTC LEXIS 196, at *10. In all cases, however,

if extrinsic evidence has been introduced, that evidence “must be considered by the Commission in reaching its

conclusion on the meaning of the advertisement.” Bristol-Meyers, 1983 FTC LEXIS 64, at *247-48; see Deception

Statement, 1984 FTC LEXIS 71, at *172-73; Thompson Medical, 1984 FTC LEXIS 6, at *324-25 (holding that

because Thompson offered extrinsic evidence, the Commission was “obliged to consider it”). The Commission

will carefully consider any extrinsic evidence that is introduced, taking into account the quality and reliability of

the evidence. See Kraft, 114 F.T.C. at 122, 1991 FTC LEXIS 38, at *14; Stouffer, 1994 FTC LEXIS 196, at *10.

b. Extrinsic evidence

Extrinsic evidence includes, but is not limited to, “reliable results from methodologically sound consumer

surveys.” Kraft, 114 F.T.C. at 121, 1991 FTC LEXIS 38, at *13; Cliffdale, 103 F.T.C. at 164-66, 1984 FTC LEXIS

71, at *108-09. In determining whether a consumer survey is methodologically sound, the Commission will look

to whether it “draws[s] valid samples from the appropriate population, ask[s] appropriate questions in ways that

minimize bias, and analyze[s] results correctly.” Thompson Medical, 104 F.T.C. at 790, 1984 FTC LEXIS 6, at

*315. “The Commission does not require methodological perfection before it will rely on a copy test or other type

of consumer survey, but looks to whether such evidence is reasonably reliable and probative. See Bristol-Myers

Co., 85 F.T.C. 688, 743-44 (1975). Flaws in the methodology may affect the weight that is given to the results of

the copy test or other consumer survey.” Stouffer, 1994 FTC LEXIS 196, at *10-11.

In addition to consumer surveys, another type of extrinsic evidence the Commission will look at is:

evidence not specifically showing how consumers understood the advertisements at issue before us, but showing

how consumers might ordinarily be expected to perceive or understand representations like those contained in the

ads we are reviewing. For example, we might look at the dictionary definition of a word to identify the word's

common usages. Or we might look at principles derived from market research, as expressed by marketing experts,

which show that consumers generally respond in a certain manner to ads that are presented in a particular way,

and presume that consumer reactions to a particular ad before us would be consistent with the general response

pattern. Where we apply such marketing principles, we will derive them from research presented in references

generally accepted as reliable in the field of marketing. Such references may be cited by marketing experts called

to testify in the proceeding.
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*180 Thompson Medical, 1984 FTC LEXIS 6, at *315-16.

A third type of evidence the Commission “will consider if offered is the opinion of expert witnesses in the

proceeding as to how an advertisement might reasonably be interpreted. For example, we might consider the

opinion of a marketing expert who stated his or her view that consumers would interpret an advertisement in a

particular manner. However, where the opinions voiced by experts are not adequately supported we ordinarily

give them little weight.” Thompson Medical, 1984 FTC LEXIS 6, at *316-17.

Whether examining the advertisement itself, extrinsic evidence, or both, the Commission considers the overall,

common-sense, net impression made by the advertisement in determining whether the alleged claim may

reasonably be ascribed to it. FTC v. Tashman, 318 F.3d 1273, 1283 (11th Cir. 2003); Kraft, 114 F.T.C. at 122;

Thompson Medical, 104 F.T.C. at 790; Stouffer 118 F.T.C. 746, 1994 FTC LEXIS 196, at *11. Ultimately,

“[t]he meaning of an advertisement, the claims or net impressions communicated to reasonable consumers, is

fundamentally a question of fact .... This question of fact may be resolved by the terms of the advertisement itself

or by evidence of what consumers interpreted the advertisement to convey.” Nat'l Urological Group, 645 F. Supp.

2d at 1189;QT, 448 F. Supp. 2d at 957-58;see also Removatron, 884 F.2d at 1497 (holding that findings with

respect to what representations are made in advertisements are factual).

c. Intent of the advertiser

Complaint Counsel urges that the evidence shows that Respondents intended to make the claims alleged in

the Complaint. Citing Telebrands Corp., 140 F.T.C. at 304 and Novartis Corp., 127 F.T.C. at 683, Complaint

Counsel argues that such intent constitutes extrinsic evidence that the Challenged Advertisements in fact conveyed

the claims alleged. Respondents deny any intent to make the disease claims alleged in the Complaint. This

Initial Decision need not, and does not, determine whether or not Respondents intended to make the disease

claims alleged in the Complaint because the evidence is sufficient to conclude that Respondents disseminated

advertisements containing the alleged claims, without regard to Respondents' alleged intent. See Section III.E.2,

infra. Moreover, to the extent Complaint Counsel is arguing that advertiser intent alone can support interpreting an

advertisement to contain an alleged claim, absent a facial analysis and/or other extrinsic evidence demonstrating

that such claim was made, that argument is rejected, as more fully explained below.

*181 It is well established that liability under Section 5 of the FTC Act does not require proof of intent to deceive.

FTC v. World Travel Vacation Brokers, Inc., 861 F.2d 1020, 1029 (7th Cir. Ill. 1988); Chrysler Corp. v. FTC,

561 F.2d 357, 363 & n.5 (D.C. Cir. 1977); Kraft, 114 F.T.C. at 121. Similarly, it is no defense to an action for

deceptive advertising that the advertiser did not intend to make the claim alleged. World Travel Vacation Brokers,

861 F.2d at 1029;FTC v. Sabal, 32 F. Supp. 2d 1004, 1007 (N.D. Ill. 1998). It would be incongruous, at best, if

intent could be used as a sword but not a shield.

Moreover, the law is clear that the goal of advertising interpretation is to determine whether reasonable consumers

would interpret an advertisement to convey an alleged claim. See, e.g., Thompson Medical, 104 F.T.C. at 788,

1984 FTC LEXIS 6, at *311 (holding that an advertisement conveys a claim if consumers, acting reasonably

under the circumstances, would interpret the advertisement to contain that message); Nat'l Urological Group, 645

F. Supp. 2d at 1189 (question of advertisement's meaning “may be resolved by the terms of the advertisement

itself or by evidence of what consumers interpreted the advertisement to convey”). Complaint Counsel's suggested

approach is contrary to law because it would have the analysis of the Challenged Advertisements focus on the

perspective of the advertiser, based on the intent of a respondent, rather than focus on the perspective of the

audience, i.e., the consumer who sees or hears the advertisement. It is also noteworthy that, while extrinsic

evidence of consumer interpretation is appropriate to consider, advertiser “intent” is not mentioned among the

types of extrinsic evidence that is considered in determining how consumers would interpret an advertisement. As
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the Commission explained in the Deception Statement, extrinsic evidence “can consist of expert opinion, consumer

testimony (particularly in cases involving oral representations), copy tests, surveys, or any other reliable evidence

of consumer interpretation.” 1984 FTC LEXIS 71, at *173 n.8 (emphasis added); see also Thompson Medical,

1984 FTC LEXIS 6, at *315-16.

In Telebrands, upon which Complaint Counsel relies, the Commission held: “Based on our own review of the

challenged advertising, we conclude that consumers would reasonably interpret respondents' Ab Force ads to

mean that the device (1) causes loss of weight, inches, or fat; (2) creates well-defined abdominal muscles; and

(3) is an effective alternative to regular exercise ....” 140 F.T.C. at 301. The Commission further held that “other

considerations,” including “ample evidence that respondents intended to convey the challenged claims,” provided

further support for the conclusions of the facial analysis. Telebrands Corp., 140 F.T.C. at 304. Similarly, in

Novartis, 127 F.T.C. at 683, also cited by Complaint Counsel, the Commission stated that “evidence of intent to

make a claim may support a finding that the claims were indeed made.” The Commission held, however, similar

to Telebrands, that the challenged claim was “plain from a facial analysis of the challenged ads alone” and that the

“extrinsic evidence” indicating respondent intended to make the challenged claim “provide[d] additional support

for [the] finding that the superiority claims” were made. Novartis, 127 F.T.C. at 683-84. Indeed, in Novartis, “the

issue of whether the claim was made [was] not a close one.” Id. at 683.

*182 Thus, while Telebrands and Novartis indicate that evidence of an advertiser's intent to make a claim

can bolster or confirm a finding that a claim was in fact made, the law does not indicate that advertiser intent

alone is a valid basis for finding that a claim was made, absent a facial analysis and/or other extrinsic evidence

demonstrating that such claim was made. In the instant case, the evidence is sufficient to conclude that Respondents

disseminated advertisements containing the alleged claims, and it is, therefore, not necessary to determine, or rely

upon, Respondents' alleged intent.

d. Target audience

Complaint Counsel argues that the Challenged Advertisements must be interpreted from the perspective of the

target audience for POM Product advertising which, according to Complaint Counsel, consists of “consumers

concerned about preventing or reducing their risk of illness.” CCB at 18. See Telebrands, 140 F.T.C. at 291

(stating that “[i]f an ad is targeted at a particular audience, the Commission analyzes ads from the perspective

of that audience” (citing Deception Statement, 1984 FTC LEXIS 71, at *178-79)); Thompson Medical, 1984

FTC LEXIS 6, *321 n.15 (recognizing precedent that persons with health-related problems can be a target

audience). In support of the argument that consumers concerned about preventing or reducing their risk of illness

constitute a “target audience” for purposes of interpreting the Challenged Advertisements, Complaint Counsel

relies principally on certain “creative briefs” prepared by POM Marketing and provided to the in-house advertising

agency, Fire Station, which served to guide Fire Station's work in developing advertising for POM Juice, POMx

Pills and Pomwonderful.com. CCFF 299-308; CX0409; F. 145-152. These creative briefs include a section titled,

“target audience,” which, for the purpose of these documents, meant the audience to whom the advertisement

would appeal. F. 148, 175. Complaint Counsel also notes that Respondents placed advertising in health-oriented

magazines, such as Prevention and Men's Fitness, in health clubs, on prescription drug bags, and on medicaloriented websites (e.g., WebMD). CCB at 19.

Respondents dispute that the creative briefs or POM's alleged focus on healthconscious consumers are probative

in this matter, and further note that the POM Products were advertised in a wide variety of local and national

publications that are not devoted to health. RRB at 49-50. Respondents do not appear to dispute, however, that

health-conscious consumers are among POM's target consumers.
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The creative briefs, as well as the fact that Respondents sought to reach healthconscious consumers by placing

advertising in such magazines as Health Magazine, Men's Health, and Men's Fitness, and in health clubs, on

prescription drug bags, and on medical219 oriented websites (e.g., WebMD), show that Respondents endeavored

to reach educated, affluent, and health-conscious individuals. F. 171, 179, 181. 7 Although at least one creative

brief for POM Pills specifically included within the “target audience,” among others, middleaged men or seniors

who are concerned or “scared” about prostate cancer, e.g., F. 178, Complaint Counsel's extrapolation from such

evidence that POM's target group was “consumers concerned about preventing or reducing their risk of illness”

in general is unpersuasive and is, therefore, rejected. Moreover, the evidence shows that Respondents' advertising

was also directed to a more general audience. F. 169-171. In particular, the evidence shows that the Challenged

Advertisements were disseminated in a wide variety of locally and nationally distributed publications, well beyond

health-oriented publications, including the Chicago Tribune, Details, Rolling Stone, InStyle, Town and Country,

Fortune, the New York Times, Discover, Popular Science, and Time. F. 169-170.

*183 In any event, even if Respondents' advertising sought to appeal to educated, affluent, and health-conscious

individuals, this conclusion has no practical utility in the instant case. As the Commission stated in Thompson

Medical, with respect to “target audiences”: “[A]lmost all advertising is targeted at some demographic group,

such as farmers, housewives, or residents of a particular area. This alone does not mean that we apply a standard

different from our customary one.” Thompson Medical, 1984 FTC LEXIS 6, *321 n.15. The term, “target

audiences,” for purposes of interpreting advertising, refers to “special audiences who as a group have a greater or

lesser capability to recognize deceptive advertising than ordinary members of the adult population or a distinctive

reaction to particular advertising claims [.]” Id. Complaint Counsel does not cite to any evidence in the record

indicating how, if at all, “educated, affluent, health-conscious consumers” would be more capable or more likely

than ordinary consumers to infer the alleged disease claims from the Challenged Advertisements. See CCB

at 18-19. In fact, what little evidence there is on the characteristics of this group indicates, if anything, that

educated, affluent, health-conscious consumers are more likely to be more discerning and careful readers of an

advertisement, and more likely to better understand an advertisement, F. 521-522, all of which weigh against a

conclusion that such consumers would be more susceptible to inferring disease claims.

In addition, the only evidence of a “distinctive reaction to particular advertising claims” among educated, affluent,

health-conscious consumers is the opinion of Complaint Counsel's rebuttal expert on, inter alia, advertising and

consumer behavior, Dr. David Stewart (see F. 285, 288), that such consumers are more likely to be “more attentive

to health claims” and more likely to “draw pragmatic inferences” about the benefits of the POM Products. F.

517. However, Dr. Stewart defined such “pragmatic inferences” as meanings that are neither expressed in the

advertisements, nor implied by the advertisements, and may or may not even follow, logically. F. 517. Finally,

as Dr. Stewart also noted, consumers are not simply passive recipients of messages, but are active processors,

and in determining how a consumer would interpret an advertisement, it is critical to consider prior beliefs,

prior knowledge, what the consumer may regard as relevant, how the consumer will process the information,

and generally what the consumer brings to the viewing situation. F. 542-543. Complaint Counsel introduced no

evidence on these considerations cited by Dr. Stewart.

In summary, while the evidence shows that Respondents' advertising may have been geared, at least in part,

toward educated, affluent, health-conscious consumers, Complaint Counsel has failed to prove that this group

would be more likely to interpret, or in fact did interpret, the Challenged Advertisements differently than ordinary

consumers, or in what manner that group would do so. Accordingly, to meaningfully analyze the Challenged

Advertisements from the perspective of the asserted target group would require unacceptable speculation, because

what constitutes such perspective, or how such perspective would be applied to the group's interpretation of

advertising, has not been proven.

2. Respondents disseminated advertisements making the claims alleged in the Complaint
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a. Summary of findings

*184 As noted above, the determination of what claims are made in an advertisement is a factual one. Removatron

Int'l Corp., 884 F.2d at 1496;AHP, 695 F.2d at 686;Nat'l Urological Group, 645 F. Supp. 2d at 1189;QT, 448 F.

Supp. 2d at 957-58. In Thompson Medical, the Administrative Law Judge (“ALJ”) described the approach that

he employed in making such determination as follows:

In determining the meaning of individual advertisements, I have primarily relied on my knowledge and experience

to determine what impression or impressions an advertisement as a whole is reasonably likely to convey to a

consumer. When my initial determination is confirmed by the expert testimony of complaint counsel or respondent,

I rested. When my initial determination disagreed with that of expert testimony, which was often conflicting, I

reexamined the advertisement in question, and further considered other record evidence such as copy tests and

other consumer research before reaching a final determination. I have not relied on such extrinsic evidence when,

after careful study and reflection, I found it to be unpersuasive and contrary to the weight of evidence.

Thompson Medical, 1984 FTC LEXIS 6, *82-83 (Initial Decision).

Employing and applying the above methodology, based upon a facial analysis and having considered all

applicable extrinsic evidence, this Initial Decision finds that certain Challenged Advertisements disseminated by

Respondents made the claims alleged in the Complaint. F. 579-584. Therefore, Complaint Counsel has satisfied

the first element of its deceptive advertising claim. See Kraft, 970 F.2d at 314. Detailed findings of fact are set forth

in Section II.D, supra and summarized, as applicable, in the following analysis. See also Initial Decision Appendix

(containing advertisements found to have made the alleged claims). The reasoning for these findings is further

explained below. The evidence upon which Respondents rely to argue that none of the Challenged Advertisements

should be interpreted as making the challenged claims, including the opinions of their linguistics expert, Dr.

Ronald Butters (F. 259-263), have been fully considered. F. 579. With respect to those Challenged Advertisements

found to have made the alleged claims, such evidence fails to outweigh the evidence demonstrating that the claims

were in fact made, including the overall net impression of the advertisements themselves. F. 584. Respondents'

arguments are further addressed in Section III.E.2.f, infra.

As to those of the Challenged Advertisements that were not found to have made the challenged claims, this

Initial Decision finds that such claims were not reasonably clear or conspicuous on the face of the advertisements,

and that considering the interplay of all the elements of such advertisements, it could not be concluded with

confidence, on the face of the advertisements alone, that a significant minority of reasonable consumers would

interpret the advertisements to make the claims alleged in the Complaint. F. 585, 587. Among other reasons, these

advertisements: do not mention heart disease, prostate cancer, or erectile dysfunction; use vague, non-specific,

substantially qualified, and/or otherwise non-definitive language; use language and/or images that, in the context

of the advertisement, are inconsistent with the alleged claim; and/or do not draw a connection for the reader,

such as through associated explanatory text, between health benefits, or study results, and effectiveness for heart

disease, prostate cancer, or erectile dysfunction. F. 588; see also F. 585. See In re Sterling Drug, Inc., No. 8919,

102 F.T.C. 395, 1983 FTC LEXIS 66, at *477-78 (July 5, 1983) (holding that claim that Bayer aspirin relieved

tension was not apparent in advertisement depicting Bayer relieving a headache caused by tension). In the context

of these advertisements, the nature of the transaction, i.e., the purchase of a food product, or a supplement derived

therefrom, as opposed to the purchase of a drug (F. 57, 65-68, 70-72), further weighs against interpreting such

advertisements as making the alleged claims. See Deception Statement, 103 F.T.C. 110, 1984 FTC LEXIS 71,

at *172 (noting that in evaluating whether implied claim was made, the Commission will consider, among other

factors, the nature of the transaction). To this extent, the facial analysis is confirmed by the opinion of Respondents'

expert, Dr. Butters, that an advertisement promoting the consumption of food is far less likely to be interpreted

by a reasonable consumer as conveying a treatment claim, than an advertisement promoting a drug. F. 491-492.
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*185 Furthermore, as to those of the Challenged Advertisements, described above, for which the alleged claims

are not reasonably clear from a facial analysis, the weight of the applicable extrinsic evidence also fails to

demonstrate that such advertisements would be reasonably interpreted to make the claims alleged in the Complaint.

F. 589; see also F. 585. For example, Complaint Counsel relies on the Bovitz Survey, a 2009 study of billboard

headlines, commissioned by Respondents to assess the impact of their advertising campaigns. F. 544-548; see

CCFF 588. In particular, Complaint Counsel relies on the fact that forty-three percent of survey respondents in

POM's general target audience and forty-eight percent of those survey respondents that were POM Juice users,

when shown an advertisement picturing a POM Juice bottle saying, “I'm off to save PROSTATES!” and a subheadline “The Antioxidant Superpower,” said the advertisement's main idea was “good for prostates.” F. 557.

However, this vague and general interpretation is not persuasive evidence that a significant minority of reasonable

consumers would draw the further inference, when viewing an advertisement containing such language and

imagery, that the POM Products treat, prevent, or reduce the risk of “prostate cancer.” See also F. 524 (In linguistic

terms, “I'm off to save prostates” would not imply that a product will protect or rescue one from disease). Similarly,

Complaint Counsel relies on the fact that fourteen percent of survey respondents in POM's general target audience,

when shown an advertisement picturing a POM Juice bottle inside a blood pressure cuff, with the headline

“Decompress” and a sub-headline “POM Wonderful Pomegranate Juice [ ] The Antioxidant Superpower,” said

the advertisement's main idea was “helps/lowers blood pressure.” F. 555. This vague and ambiguous conclusion

is not enough to support a finding that a significant minority of reasonable consumers would draw the further

inference, when viewing an advertisement containing this language and imagery, that the POM Products treat,

prevent, or reduce the risk of “heart disease.” None of the survey respondents in the Bovitz Survey answered

that the main idea of these billboard advertisements was prevention, risk reduction, or treatment of any specific

disease. F. 555-558, 572. The most common “main idea” communicated (at least 90%) was that POM Juice had

general health benefits. F. 572. Moreover, the Bovitz Survey examined only advertisement headlines and images,

as shown on the billboard advertisements. F. 547. Thus, the Bovitz Survey did not examine the headlines, images

and text, as shown on any of the Challenged Advertisements. F. 547. As Complaint Counsel's rebuttal expert,

Dr. Stewart, acknowledged, other text that is added in a lengthier print advertisement might modify a message

communicated by the image and headline of a billboard. F. 561. For this reason as well, the findings of the Bovitz

Survey are entitled to little weight.

*186 Complaint Counsel also places too much weight on opinions that Complaint Counsel obtained from Dr.

Butters on cross-examination that phrases such as “prostate health” and “heart health” would be interpreted to

mean the absence of disease. F. 538-539. While the meaning of “health” may well include the absence of disease,

the meaning of “health” is surely not so limited as to include only treatment, prevention or reduction of the risk

of disease, and to the extent Dr. Butters opined as such, that opinion is rejected.

Accordingly, because, as to certain Challenged Advertisements, the alleged claims are not reasonably clear or

conspicuous on the face of the advertisements themselves, and because the applicable extrinsic evidence of the

meaning of those advertisements is insufficient or unpersuasive, this Initial Decision finds that the evidence fails

to demonstrate that such advertisements made the claims alleged in the Complaint. F. 587-590; see also F. 585. See

Sterling Drug, 1983 FTC LEXIS 66, at *477-78 (stating Commission was “unwilling in the absence of extrinsic

evidence to find that consumers infer from these ads that Bayer will relieve tension” where such claim was “not

apparent ... from a careful examination of the ads”); Thompson Medical, 104 F.T.C. at 339-40 (holding that

Commission “cannot find the ad to convey” implied claim that Aspercreme contained aspirin where Commission

was unable to “conclude with adequate confidence” based on the advertisement itself “whether or not one message

conveyed to consumers” was that Aspercreme contained aspirin and where extrinsic evidence was insufficient

to find such claim). It is worth emphasizing that this is not a finding that the advertisements do not convey the

alleged claims, but merely that the evidence was insufficient to conclude that they do. As the Commission stated

in Thompson Medical:
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Here we merely say that complaint counsel failed to provide extrinsic evidence demonstrating that [the

advertisements] created a net impression which did [make the challenged claim]. We do not attempt to use our

judgment to reach any substantive conclusion. Where the implied meanings of an advertisement are unclear absent

extrinsic evidence, our expertise is no more reliable in permitting conclusions that an interpretation is unreasonable

than that it is reasonable.

Thompson Medical, 1984 FTC LEXIS 6, at *371.

To be clear, Complaint Counsel has demonstrated, based on a number of the Challenged Advertisements, that

Respondents did, in fact, disseminate some advertisements making the claims alleged in the Complaint. It is not

necessary to find that all the Challenged Advertisements made the alleged claims in order to warrant injunctive

relief for deceptive advertising. Bristol-Meyers, 1983 FTC LEXIS 64, at *250-51 (disagreeing with ALJ findings

that certain advertisements made the challenged claims, and stating: “Although we find a smaller number of

violative ads than did the ALJ, there is certainly an adequate number to support the order ...”); Fedders Corp., No.

8932, 85 F.T.C. 38, 71-72, 1975 FTC LEXIS 282, *72 (Jan. 14, 1975) (“The Commission has previously issued

orders in cases involving no more than one or a few deceptive advertisements.”).

b. “Establishment” claims vs. “efficacy” claims

*187 Advertisements that claim a certain type or level of support are considered “establishment claims.”

Thompson Medical, 791 F.2d at 194. An establishment claim includes a claim that the effectiveness of a product

has been shown by clinical proof. Removatron, 884 F.2d at 1492 n.3. As the Commission stated in Thompson

Medical: “There is no conceptual or practical reason to single out such claims [ ] for special treatment. They are

but one example of an express or implied claim that an advertiser possesses a particular level of substantiation.”

1984 FTC LEXIS 6, at *387 n.59; see also Bristol-Meyers, 1983 FTC LEXIS 64, at *253 (noting that a claim

of clinical proof can be express or implied). A claim that a product is effective, without expressly or impliedly

representing a particular level of support, is not an establishment claim, but is an efficacy claim. Removatron,

884 F.2d at 1491 n.3.

The majority of the Challenged Advertisements that have been found herein to have made the claims alleged in

the Complaint represented that clinical studies supported the claimed effectiveness of the POM Products, and,

therefore, are referred to herein as “establishment claims.” The remainder of the Challenged Advertisements found

to have made the claims alleged in the Complaint made non-establishment, “efficacy” claims.

c. Heart disease claims

The evidence shows that Respondents disseminated advertisements that impliedly represented that the POM

Products treat, prevent, or reduce the risk of heart disease and, in many of these same advertisements, are clinically

proven to do so, by lowering blood pressure, reducing arterial plaque, and/or increasing blood flow to the heart.

F. 580, 583. Respondents made these claims indirectly and obliquely, typically by presenting, through words and

images, a logical syllogism that: free radicals cause or contribute to heart disease; the POM Products contain

antioxidants that neutralize free radicals; and, therefore, the POM Products are effective for heart disease. F.

294-295, 301-303, 348, 374, 394-396, 398, 407, 414, 444, 452-453, 460-462. Against this background, many of

the advertisements further state or represent that the POM Products have been shown in one or more clinical,

medical, or scientific studies, to reduce plaque, lower blood pressure, and/or improve blood flow to the heart,

in a context where it is readily inferable that the referenced study results involve heart disease risk factors and,

therefore, constitute clinical support for the effectiveness claim. F. 295, 301, 303, 349, 373, 376, 379, 395-397,

400, 407, 414, 420.
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For example, in April 2009, the “Cardiovascular” section of the health benefits webpage of pomwonderful.com

had a “read more” link that took the viewer to text stating that “heart disease” is a leading killer of men and

women in the United States, that “atherosclerosis,” which is defined for the reader as too much “plaque,” is a

leading factor in “heart attacks,” and further describes the role of antioxidants in reducing LDL (defined as “bad”

cholesterol) oxidation. F. 373-374. The “read more” links from this page connect to a 2005 study on the effect

of pomegranate juice on myocardial perfusion published in the American Journal of Cardiology; a 2004 study

on reduction of carotid intima-media thickness, blood pressure (CIMT-BP) and LDL oxidation; and a 2001 study

on reduction of systolic blood pressure. F. 374. The “Cardiovascular” section of the health benefits webpage of

pomwonderful.com also advised the reader that POM Juice was shown in one study to improve blood flow to

the heart in “coronary heart disease” “patients”; and, in another study, to reduce arterial plaque. F. 373. In this

context, asserting clinical proof of a beneficial effect on the underlying conditions of the body (blood flow, arterial

plaque, CIMT-BP, and LDL) would reasonably be interpreted as representing clinical proof of effectiveness for

heart disease. F. 373-375, 381.

*188 Another example is the Heart Newsletter (CX1426 (Compl. Ex. M); F. 346-350), which states or represents

that (1) “58.8 million Americans suffer from some form of heart disease”; (2) supplementation with antioxidants is

“your ally” in fighting “heart disease”; (3) antioxidants fight free radicals and help prevent cell and tissue damage

that lead to “disease”; (4) POM Juice and POMx have polyphenol antioxidants, which are unique and superior;

and (5) POMx provides antioxidant supplementation without adding the calories of POM Juice. F. 348. The Heart

Newsletter further states that POM's “scientists have found” that POM Juice “may help counteract factors leading

to arterial plaque buildup, as well as inhibit a number of factors associated with heart disease.” F. 349. The text then

proceeds to describe these findings, from “new research,” including (1) a “pilot” study involving 19 “patients”

with “clogged arteries” which found a “30% decrease in arterial plaque” among those drinking eight ounces of

POM Juice daily; and (2) a study involving 45 “patients” with “impaired blood flow to the heart,” showing “17%

improved blood flow” among those who consumed eight ounces of POM Juice daily. F. 349. By connecting

POM-provided antioxidants to benefits for “heart disease,” and by further connecting the study results to heart

disease risk factors, the advertisement implies that the POM Products are effective for heart disease, and that such

effectiveness is based upon clinical testing. F. 350. See also F. 301 (CX0029 print advertisement representing,

inter alia, that “heart attacks are due to ... plaque in the arteries” and “scientific research shows” that POM Juice

prevents LDL oxidation and reduces plaque); F. 414 (CX0473 Ex. E-1 (pomegranatetruth.com)), representing

that “atherosclerosis,” which is defined for the reader as too much “plaque,” is a leading factor in “heart attacks”

and linking to research studies on the effects of pomegranate juice on myocardial perfusion, reduction of carotid

intima-media thickness, blood pressure, and LDL oxidation); F. 339-340, 419-420.

The Challenged Advertisements that were not found to have made establishment claims, as alleged by Complaint

Counsel, but which were found to have made heart disease efficacy claims only, either do not reference any

clinical testing or refer to clinical testing in such a way, and in such context, that it cannot be concluded with

confidence that a significant minority of reasonable consumers would take away the message that the efficacy

claim is “clinically proven.” See F. 440-448 (CX0031 (“Floss your arteries”)); F. 456-468 (CX0034 (“Amaze your

cardiologist”)). For example, CX0031 represents that “clogged arteries lead to heart trouble,” free radicals cause

“artery clogging plaque,” and that drinking eight ounces of POM Juice a day “can reduce plaque up to 30%!*”

F. 444. While this advertisement makes an efficacy claim, the only reference to any scientific support is in very

small print, at an asterisk at the bottom of the page, which states: “Aviram, M. Clinical Nutrition, 2004. Based on

a clinical pilot study.” F. 447. CX0034 is a similar advertisement. F. 466.

*189 As the Commission stated in Bristol Meyers, not “every reference to a test necessarily gives rise to an

establishment claim. The key, of course, is the overall impression created by the ad.” 1983 FTC LEXIS 64,

at *253. In CX0031 and CX0034, this small print, single reference to a study, particularly in the context of

a qualified assertion that POM Juice “can” reduce plaque, is insufficient to conclude with confidence that a
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significant minority of reasonable consumers would interpret these advertisements to be claiming that POM Juice

is “clinically proven” to be effective for heart disease. F. 446-447, 466-467. Moreover, the applicable extrinsic

evidence does not support a conclusion that consumers would interpret these advertisements to be making a

“clinically proven” claim. F. 579, 585. Accordingly, the evidence fails to demonstrate that these advertisements,

which do make efficacy claims, convey the additional message that POM Juice's efficacy is demonstrated by

clinical proof. F. 448, 468, 585.

d. Prostate cancer claims

The evidence shows that Respondents disseminated advertisements that impliedly represented that the POM

Products are clinically proven to treat, prevent, or reduce the risk of prostate cancer, by prolonging prostatespecific antigen (“PSA”) doubling time. F. 581. These advertisements typically communicate the claim by

juxtaposing statements and representations that prostate cancer is a leading cause of death in men; antioxidants,

such as those provided by the POM Products, may help prevent cancer; that PSA is an indicator of prostate cancer;

that PSA doubling time is an indicator of prostate cancer progression; and that the POM Products have been

shown in clinical testing to slow PSA doubling time. F. 310-318, 332, 334-336, 352-353, 371, 381, 389-392, 398,

400-405, 409, 429-430. Thus, similar to those advertisements found herein to have made heart disease claims,

these advertisements specifically refer to prostate cancer, and connect both POM-provided antioxidants, and the

study results, to effectiveness for prostate cancer. Id.

For example, CX1426 (Compl. Ex. I) (POMx Pill package insert) juxtaposes statements and representations that:

(1) antioxidants fight free radicals, which may be linked to “serious health threats like cancer ...”; (2) “Prostate

cancer is the most commonly diagnosed cancer ... and the second-leading cause of cancer death” among men in

the United States; (3) POMx is a “time pill” because “stable levels of PSA,” which is defined for the reader as

“prostate-specific antigens,” “are critical for men with prostate cancer,” and “[p]atients with quick PSA doubling

times are more likely to die from their cancer”; (4) “[a]ccording to a UCLA study of 46 men age 65 to 70 with

advanced prostate cancer, drinking an 8oz glass of POM Wonderful 100% Pomegranate Juice every day slowed

their PSA doubling time by nearly 350%. 83% of those who participated in the study showed a significant decrease

in their cancer regrowth rate”; and (5) “basic studies” indicate POMx may have the same effects as POM Juice.

F. 332, 334.

*190 Similarly, the Prostate Newsletter (CX1426 (Compl. Ex. N)) states and represents that: (1) “Prostate

cancer is the second leading cause of cancer related death in men in the United States ...”; (2) “risk factors” for

prostate cancer include “diet,” and advises a diet that includes, among other things, “fruits rich in antioxidants”;

(3) a “preliminary UCLA medical study” on 46 men treated for prostate cancer, showed that a majority of

those consuming eight ounces of POM Juice daily “experienced a significantly extended PSA doubling time.

Doubling time is an indicator of prostate cancer progression — extended doubling time may indicate slower

disease progression”; testing on “patient” blood serum showed a decrease in “cancer cell proliferation,” and

“increase in cancer cell death”; (4) in another study, “in vitro laboratory testing at UCLA showed that POMx

significantly decreased human prostate cancer cell growth and increased cancer cell death”; and (5) POMx has

the same active ingredients in POM Juice. F. 352-353. See also F. 311 (regarding CX0314, CX0372, CX0379,

CX0380, representing, inter alia, that according to a published study on men treated for prostate cancer, those

consuming POM Juice “experienced significantly slower” “PSA doubling times,” and that PSA “is a biomarker

that indicates the presence of prostate cancer. ‘PSA doubling time’ is a measure of how long it takes for PSA levels

to double. A longer doubling time may indicate slower progression of the disease”); F. 371, 380-381, 403-404,

409, 430.

e. Erectile dysfunction
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The evidence demonstrates that Respondents disseminated advertisements that impliedly represented that the

POM Products are clinically proven to treat, prevent or reduce the risk of erectile dysfunction (“ED”). F. 582.

Respondents disseminated print advertisements that stated and represented, for example, that: (1) the superior

antioxidants in the POM Products protect against free radicals, which can damage the body; (2) powerful

antioxidants enhance the actions of nitric oxide in vascular endothelial cells, showing potential for management

of “ED”; and (3) a preliminary study on “erectile function” showed that men who consumed POM Juice reported

“a 50% greater likelihood of improved erections,” as compared to a placebo. F. 323-324. Similarly, in April

2009, the “Erectile Function” section of the health benefits webpage on pomwonderful.com reported that a

2007 “pilot” study, published in the Journal of Impotence Research, involving 61 male subjects with “mild to

moderate erectile dysfunction,” showed that those men drinking eight ounces of POM Juice daily for four weeks

were “50% more likely to experience improved erections.” F. 372. See also F. 380-381, 433-437. Presenting a

study on “erectile function” showing “improved erections” is reasonably read to imply effectiveness for erectile

dysfunction, particularly when juxtaposed to an express reference to management of “ED.” F. 323-325. See also F.

408 (response to the FAQ “Erectile Dysfunction” “Can pomegranate juice benefit men with erectile dysfunction?”

stating, “Initial results linking POM Wonderful 100% Pomegranate Juice and erectile performance are promising.

In a soon-to-be-published clinical study on men with erectile dysfunction, the group who consumed 8oz. of

POM Juice daily experienced better erectile performance than the group who drank a placebo”). Moreover, as

Respondents' expert, Dr. Butters, acknowledged, contemporary speakers of American English could interpret the

phrase “erectile function” to relate to the ability of men to achieve and maintain erections. Erectile function and

the absence of erectile dysfunction are closely related. F. 537.

f. Respondents' arguments as to advertisement interpretation

*191 As noted above, the determination of whether any of the Challenged Advertisements conveyed the implied

claims alleged in the Complaint is a question of fact. Removatron, 884 F.2d at 1496;AHP, 695 F.2d at 686;Nat'l

Urological Group, 645 F. Supp. 2d at 1189;QT, 448 F. Supp. 2d at 957-58. As to those Challenged Advertisements

found herein to have made the challenged claims, this factual question has been resolved against Respondents.

This determination is based upon all the evidence, including full consideration and weighing of all the evidence,

inferences, and arguments raised by Respondents in opposition to finding that the challenged claims were made.

As to those Challenged Advertisements found herein to have made the challenged claims, Respondents' opposing

evidence, inferences and arguments, have been rejected as unpersuasive, unsupported, or otherwise outweighed by

other evidence, including the overall net impression of the advertisements themselves. Respondents' contentions

that require further elaboration are discussed below.

Respondents contend that the challenged claims are not reasonably clear or conspicuous on the face of any of

the Challenged Advertisements, and that Complaint Counsel failed to present any reliable extrinsic evidence

showing that reasonable consumers would interpret the advertisements to make the alleged claims. Therefore,

Respondents argue, Complaint Counsel failed to meet its burden of proving that the challenged claims were

made. See, e.g., RB at 71-74. Respondents accurately assert that Complaint Counsel did not offer a copy test

on the Challenged Advertisements. Complaint Counsel also did not proffer any expert opinion or analysis

of the Challenged Advertisements to demonstrate that reasonable consumers would interpret the Challenged

Advertisements as making the alleged claims. F. 513. As to those Challenged Advertisements for which the alleged

claims were not reasonably clear or conspicuous on the face of the advertisements alone, see F. 587-588; see also

F. 585, such a copy test or expert analysis provided by Complaint Counsel might have made a material difference.

However, the failure of Complaint Counsel to proffer such extrinsic evidence is not fatal to Complaint Counsel's

case because, for those Challenged Advertisements found to have made the alleged claims, the claims are, in

fact, apparent from the overall, common-sense, net impression, of the words and images of the advertisements

themselves. F. 293, 299, 310, 325, 331, 338, 346, 351, 368, 387, 411, 417, 422, 429, 433, 443, 455, 463, 474.
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Moreover, Complaint Counsel adduced some extrinsic evidence relevant to consumer interpretation, albeit on

cross-examination and rebuttal, which has also been considered. F. 579; see, e.g., F. 527, 533-537, 540-541.

*192 Respondents further contend that the Challenged Advertisements must be interpreted in the context of the

purchase of food, or a food-derived product, as opposed to the purchase of a drug, and that when viewed from this

perspective, the advertisements are not reasonably interpreted, including by a facial analysis alone, as conveying

the claim that the POM Products “prevent,” “treat,” or “reduce the risk” of any disease. See, e.g., RB at 72, 78-82.

Respondents argue in the alternative that, to the extent consumers would interpret the Challenged Advertisements

as claiming that the POM Products “may help prevent” or “reduce the risk” of heart disease, prostate cancer or

erectile dysfunction, it is in the same sense that broccoli, a healthy diet, or exercise “reduce the risk” of disease,

and not in the sense of a drug, with a single target of action. Id.; see also RRB at 20-22. Further, Respondents argue

that to the extent reasonable consumers would interpret the Challenged Advertisements as making a “treatment”

claim, it would not be in the sense of a substitute for medical treatment. RB at 72. Respondents fail to explain how

such a limited interpretation is legally significant since such claims would still appear to be within the scope of

the claims alleged in the Complaint. In any event, Dr. Butters, whose testimony Respondents cite, did not testify

to the interpretation urged by Respondents. RB at 73-74, 78-82 (citing Butters, Tr. 2817-18, 2821). In the cited

testimony, Dr. Butters opined that what people might infer with respect to a food product might be different than

what they might infer with respect to a drug; that an advertisement promoting the consumption of food is far less

likely to be interpreted by a reasonable consumer as conveying a treatment claim; and that the word “treatment”

means medical treatment. See F. 491-492. Dr. Butters simply did not opine that consumers would interpret the

Challenged Advertisements in the manner claimed by Respondents. Moreover, as noted above, the nature of the

transaction (i.e., the purchase of a food product or food-derived supplement) has been considered in determining

the meaning of the Challenged Advertisements. With respect to those of the Challenged Advertisements for which

the challenged claims were not reasonably clear or conspicuous on the face of the advertisements themselves,

the opinions of Dr. Butters, set forth above, have been taken into account. As to other advertisements, the nature

of the POM Products as food, or food-derived, was insufficient to outweigh the overall net impression that such

advertisements conveyed the alleged claims. See, e.g., F. 296, 305. 8

Respondents argue that the Challenged Advertisements are not reasonably interpreted as making “broad”

establishment claims, because they simply report study results, in a qualified manner with words such as

“preliminary,” “promising,” “encouraging,” or “hopeful,” and are not reasonably interpreted as implying that the

study results prove that the POM Products treat, prevent, or reduce the risk of disease. See, e.g., RB at 75-82; RRB

at 10-15. However, in the context of the Challenged Advertisements found to have made establishment claims,

the foregoing language fails to materially alter the overall net impression that such advertisements were claiming

clinical proof. E.g., F. 300-301, 312, 333, 342, 349-350, 354; see also F. 519 (Dr. Stewart opining that the typical

consumer would likely have little understanding of what “initial” or “pilot” means, particularly in the context of

being referred to as having been published in a major journal).

*193 Similarly, Respondents assert that advertising that a study on POM Juice showed “prolongation of PSA

doubling times” does not convey the claim that POM Juice has been clinically proven to treat, prevent, or reduce

the risk of “prostate cancer,” and that advertising a study that POM Juice consumption resulted in “significant

reduction of ... arterial plaque” or “improvement in blood flow” does not convey a claim of clinical proof of

prevention, treatment, or reduction of the risk of “heart disease.” RRB at 10. However, as explained above,

those of the Challenged Advertisements found to have made “clinically proven” claims expressly referred to

“heart disease,” e.g., F. 294, 301, 348, 374, 407, 414, “prostate cancer,” e.g., F. 334, 352, 381, 403, and “erectile

dysfunction,” F. 408, 413, or “erectile function” together with the phrase, “ED,” F. 324, 434, and drew a

logical connection for the reader, including through associated explanatory text, between the study results and

effectiveness for the referenced maladies. E.g., F. 301-303, 323-325, 348-350, 353, 374, 379-380, 414. Thus, in
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the context of these advertisements, reasonable consumers would readily infer that the study results constituted

clinical proof of effectiveness for the referenced maladies.

In addition, contrary to Respondents' argument, the preponderance of the evidence does not support a finding

that the use of qualified language, such as “may” or “can” necessarily prevents communication of a more

definitive claim. To the extent Dr. Butters opined to this effect, see F. 497, that opinion is rejected as unsupported

and inconsistent with common-sense. First, there is academic literature in the record indicating that qualifiers

such as “can,” “could,” “might,” or “up to” can create the inference of a stronger claim. F. 589. Moreover,

whether a consumer will interpret “may” or “can” to mean “will” depends on the context, and the totality of the

advertisement. F. 527.

Finally, Respondents contend that interpreting any of the Challenged Advertisements to make the alleged claims

ignores the role of humor, parody, or hyperbole present in Respondents' advertising. Notwithstanding Dr. Butters'

opinion on this issue, F. 487-489, the preponderance of the evidence demonstrates that humor, parody, or

hyperbole within an advertisement does not necessarily “block” communication of a serious message within that

advertisement. Rather, as Dr. Butters acknowledged, parody and humor have the effect of capturing the attention of

the advertisement viewer, to help the viewer connect with the message in the printed portion of the advertisement.

F. 534. Humor can induce further processing of an advertisement and a search for further information. F. 535.

While readers may discount puffery and hyperbole as an exaggeration, the fact that puffery and hyperbole are

not to be taken literally does not mean that advertisements using such elements cannot convey a serious claim. F.

532-533. Thus, the fact that a number of the Challenged Advertisements found to have made the alleged claims

made partial use of humor or hyperbole is insufficient, in the context of the other elements of those advertisements,

to prevent conveying the challenged claims. See, e.g., F. 300-301, 320, 327, 464, 476. 9

F. Whether the Challenged Claims are False or Misleading

1. Overview of applicable legal standards

*194 Having found that Respondents disseminated advertisements making the claims alleged in the Complaint,

the next step is to determine whether the claims are false or misleading. Kraft, 970 F.2d at 314;Pantron I Corp.,

33 F.3d at 1095;Direct Marketing Concepts, 569 F. Supp. 2d at 297. Two theories have been used to prove that an

advertisement is deceptive or misleading: (1) the “falsity” theory or (2) the “reasonable basis” theory. Pantron I, 33

F.3d at 1096;Thompson Medical, 1984 FTC LEXIS 6, at *380-81. Complaint Counsel contends that Respondents'

claims are deceptive because they are both “false” and “unsubstantiated.” CCB at 36. Notwithstanding Complaint

Counsel's contention, as further explained below, the issue of whether Respondents' claims were deceptive turns

on the nature and quality of Respondents' substantiation, and, therefore, “the falsity and reasonable basis theories

collapse into the same inquiry: did [Respondents] possess adequate substantiation to make such a claim?” QT,

Inc., 448 F. Supp. 2d at 966.

The Complaint charges that Respondents have represented that clinical studies, research, and/or trials prove that

the POM Products treat, prevent, or reduce the risk of heart disease, prostate cancer, and/or erectile dysfunction,

when in fact, studies, research and/or trials do not prove such claims, and, therefore, Respondents' representations

are false or misleading. Complaint ¶¶ 12-18. Complaint Counsel refers to these claims as “false establishment

claims.” CCB at 20-24. The Complaint also charges that Respondents represented that the POM Products treat,

prevent, or reduce the risk of heart disease, prostate cancer, and/or erectile dysfunction without a reasonable

basis to substantiate those representations. Complaint ¶¶ 19-21. Complaint Counsel refers to these charges as

“unsubstantiated efficacy claims.” CCB at 25-26.
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Establishment claims are those that contain representations regarding the amount and type of evidence the

advertiser has for its product claims. In re Daniel Chapter One, No. 9329, 2009 FTC LEXIS 259, at *55 (Dec.

24, 2009); Direct Marketing Concepts, 569 F. Supp. 2d at 298 (citing FTC Policy Statement on Advertising

Substantiation, appended to Thompson Medical, 104 F.T.C. at 839, 1984 FTC LEXIS 6, at *434). The

establishment claim theory “is based on the straightforward notion that when an advertiser represents in its ads

that there is a particular level of support for a claim, the absence of that support makes the claim false.” Sterling

Drug, 1983 FTC LEXIS 66, at *436. Common examples of establishment claims include statements such as “tests

prove,” “doctors recommend,” or “studies show.” Direct Marketing Concepts, 569 F. Supp. 2d at 298-99 (citing

Policy on Advertising Substantiation; Thompson Medical, 791 F.2d at 194) (other citations omitted). Complaint

Counsel bears the burden of demonstrating that the level of support represented by Respondents was false, i.e.,

that Respondents did not have the amount and type of substantiation they claimed to have had. See Sterling Drug,

1983 FTC LEXIS 66, at *437; Thompson Medical, 791 F.2d at 194;Bristol-Meyers, 1983 FTC LEXIS 64, at *252.

*195 Non-establishment claims, or “efficacy claims,” are those about a product's attributes, performance, or

efficacy, without indicating any particular level of support for such claim. Thompson Medical, 1984 FTC LEXIS

6, at *368; Removatron 884 F.2d at 1492 n.3 (“‘Non-establishment’ claims are statements to the effect that a

product works.”). Under the reasonable basis theory of deception, because claims about a product's attributes,

performance, or efficacy carry with them the express or implied representation that the advertiser had a reasonable

basis substantiating such claims, failure to have a reasonable basis for the claim is deceptive or misleading. Pantron

I, 33 F.3d at 1096;QT, Inc., 448 F. Supp. 2d at 959-60;Direct Marketing Concepts, 569 F. Supp. 2d at 298;

Thompson Medical, 1984 FTC LEXIS 6, at *367; Daniel Chapter One, 2009 FTC LEXIS 157, at *222 (Initial

Decision). Under the reasonable basis theory, the government has the burden of proving by a preponderance of

evidence that the Respondents did not have a reasonable basis for asserting that the challenged claims are true.

Pantron I, 33 F.3d at 1096;QT, Inc., 448 F. Supp. 2d at 959;Thompson Medical, 1984 FTC LEXIS 6, at *379.

Thus, as to both the alleged “false establishment claims” and the alleged “unsubstantiated efficacy claims,” proof

of deception requires proof that Respondents' substantiation failed to meet the level of substantiation required.

The district court in FTC v. QT, Inc. described the shifting burdens as follows:

[T]he Court must first determine what level of substantiation Defendants were required to have for their advertising

claims, and this determination is a question of fact. Then, the Court must determine whether Defendants possessed

that level of substantiation .... Defendants have the burden of establishing what substantiation they relied on for

their product claims. The FTC has the burden of proving that Defendants' purported substantiation is inadequate,

and the FTC need not conduct or present clinical studies showing that the product does not work as claimed.

448 F. Supp. 2d at 959 (citations omitted).

For efficacy claims, the Commission, in Thompson Medical, held that determining the appropriate level of

substantiation requires weighing the following factors: (1) the product involved; (2) the type of claim; (3) the

benefits of a truthful claim; (4) the ease of developing substantiation for the claim; (5) the consequences of a false

claim; and (6) the amount of substantiation experts in the field would agree is reasonable. 1984 FTC LEXIS 6,

at *387 (citing In re Pfizer, Inc. No. 8819, 81 F.T.C. 23, 1972 FTC LEXIS 13, at *91 (July 11, 1972)). Those

factors, known as the “Pfizer factors,” have been applied to determine the appropriate level of substantiation for

non-establishment claims in numerous cases since Pfizer was decided. E.g., Direct Marketing Concepts, 569 F.

Supp. 2d at 299 (citing Removatron, 884 F.2d at 1492 n.3);QT, Inc., 448 F. Supp. 2d at 959 (citing Policy on

Advertising Substantiation).

*196 For establishment claims, the Commission does not require application of the Pfizer factors to determine the

required level of substantiation, on the theory that the advertiser must be held to whatever level of substantiation

is represented in the advertisement. In re Removatron Intl Corp., No. 9200, 111 F.T.C. 206, 1985 FTC LEXIS 21,
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at *190 (Sept. 30, 1985); Thompson Medical, 1984 FTC LEXIS 6, at *387 n.59. If an advertisement represents

that a particular claim has been scientifically established, the advertiser must possess a level of proof sufficient to

satisfy the relevant scientific community of the claim's truth. Removatron, 1985 FTC LEXIS 21, at *191 (citing

Thompson, 104 F.T.C. at 821-22 n.59; Bristol-Meyers, 102 F.T.C. at 321, 331).

Complaint Counsel charges that Respondents knew that their scientific studies were insufficient to support their

efficacy and establishment claims. CCB at 3. See also e.g., CCB at 41 (Complaint Counsel contending that

Respondents “recognize[d] that they lack[ed] proof that the POM Products prevent or treat” heart disease).

However, any opinions Respondents may have had regarding the adequacy of their substantiation do not constitute

expert opinion on what “experts in the field would agree is reasonable” or on whether “the level of proof [relied

upon is] sufficient to satisfy the relevant scientific community of the claim's truth.” Accordingly, such evidence

is not material or probative to the issue of whether Respondents possessed an adequate level of substantiation.

With these generally applicable principles in mind, to determine whether the challenged claims are false or

misleading, it must first be determined what level of substantiation Respondents were required to have for their

advertising claims. QT, Inc., 448 F. Supp. 2d at 959. This determination is a question of fact to be determined

based upon the evidence adduced at trial. QT, Inc., 448 F. Supp. 2d at 959;FTC v. Braswell, CV 03-3700 DT, 2005

U.S. Dist. LEXIS 42976, at * 35 (C.D. Cal. 2005). Next, it must be determined whether Respondents possessed

that level of substantiation. QT, Inc., 448 F. Supp. 2d at 959. Respondents have the burden of establishing what

substantiation they relied on for their product claims. Id. Complaint Counsel has the burden of proving that

Respondents' purported substantiation is inadequate. Id.

2. Appropriate level of substantiation generally

*197 A review of the briefs in this case reveals that there is no dispute that the appropriate level of substantiation

is “competent and reliable scientific evidence,” both for Respondents' establishment claims and for Respondents'

efficacy claims. The parties' dispute centers upon what constitutes “competent and reliable scientific evidence.”

See, e.g., CCB at 2-3, 30, 40; CCRB at 18; RB at 32-38.

Complaint Counsel asserts that competent and reliable scientific evidence must include “RCTs,” which experts

define as well-designed, well-conducted, randomized, double-blind, placebo-controlled human clinical trials, (F.

608) in order to provide adequate substantiation for both the alleged establishment claims and efficacy claims

in this case. CCB at 32; CCRB at 18. Respondents dispute this notion, asserting that, in examining the totality

of the evidence, basic science and “pilot” studies, not just RCTs, can be relied upon as competent and reliable

evidence. RB at 32-38. “Basic science” refers to test-tube (in vitro) studies, in vivo animal studies, and pre-clinical

research. F. 593.

As explained below, neither the FTC Act nor applicable case law imposes a requirement of RCTs to substantiate all

“health-related efficacy claims,” as urged by Complaint Counsel. CCB at 32. Rather, and as Complaint Counsel's

cited cases make clear, the determination of the appropriate level of substantiation is a question of fact to be

determined based upon the expert testimony adduced at trial. QT, Inc., 448 F. Supp. 2d at 959;FTC v. Braswell,

2005 U.S. Dist. LEXIS 42976, at *35.

a. RCTs are not a legal requirement

In its Post-Trial Brief, Complaint Counsel asserts that “[c]ourts have consistently found or upheld that doubleblind, randomized, placebo-controlled trials (“RCTs”) are required to provide adequate substantiation for the

truthfulness of health-related claims.” CCB at 32. As a matter of law, “[n]othing in the Federal Trade Commission

Act ... requires placebo-controlled, double-blind studies.” FTC v. QT, Inc., 512 F.3d 858, 861 (7th Cir. 2008).
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Further, contrary to Complaint Counsel's assertion, the cases upon which Complaint Counsel rely do not compel

a conclusion that RCTs are required.

Complaint Counsel cites FTC v. Direct Marketing Concepts, Inc., 569 F. Supp. 2d at 303, for the proposition that

double-blind, placebo controlled studies are required to substantiate health-related efficacy claims. Although the

district court in Direct Marketing stated, “it seems well-accepted that double-blind, placebo-controlled studies

are necessary to substantiate health-related efficacy claims,” id. at 303, the First Circuit Court of Appeals,

when reviewing the district court's opinion, expressly noted that while the FTC had argued and produced expert

testimony that the claims at issue should be substantiated by double-blind, placebo-controlled studies, “there may

be other scientific evidence that could be sufficient, and we may assume for these purposes that a double-blind

study is not necessarily required.” FTC v. Direct Marketing Concepts, Inc., 624 F.3d 1, 9 (1st Cir. 2010).

*198 Complaint Counsel next cites National Urological Group, 645 F. Supp. 2d at 1202-03. However, in that

case, which was before the court on the FTC's motion for summary judgment, the court did not hold that claims for

erectile dysfunction “required” double-blind placebo-controlled studies, as Complaint Counsel suggests. Instead,

the court stated, “what constitutes competent and reliable scientific evidence in this case is a question of fact for

expert interpretation.” Id. at 1190. In National Urological Group, the expert testimony was undisputed that the

erectile dysfunction claims made in that case required well-designed, placebo-controlled, randomized, doubleblind clinical trials for substantiation. Because the “defendants ha[d] not countered the testimonies of the FTC's

expert regarding what level of substantiation is required for the claims made,” the court concluded that there was

no genuine dispute of fact on the requisite level of substantiation. Id. at 1202. In the instant case, by contrast,

expert testimony on whether RCTs are required was clearly disputed and conflicting.

In FTC v. Braswell, 2005 U.S. Dist. LEXIS 42976, also cited by Complaint Counsel, defendants advertised

the dietary supplements Lung Support Formula, AntiBetic Pancreas Tonic and Gero Vita GH3, one of which

was advertised as a substitute for medical treatments. Id. at *4, *20-21 (AntiBetic). The court found that, by

offering unrefuted evidence that the standard should be double-blind, placebo-controlled tests, the FTC had

offered sufficient evidence to withstand summary judgment. Id. at *35. The court further noted that the ultimate

determination of the level of substantiation required would be determined by the court based upon the evidence

at trial. Id.

Complaint Counsel also relies on Removatron, 884 F.2d 1489 (1st Cir. 1989), where the Court of Appeals

upheld the Commission's determination that a well-controlled scientific study was necessary to substantiate the

respondent's claims that a radio frequency energy hair removal device would permanently remove hair. Id. at

1498. The court explained the basis for its holding as follows: “The FTC's expert, Dr. Van Scott, testified that,

in this field, at least one well-controlled test would be needed to establish a permanency claim. He also testified

that two tests would be better and three superb. The ALJ found that petitioners needed two well-controlled tests

in order to establish their claims; the Commission decided one was sufficient. Thus, petitioners needed to present

evidence that they possessed at least one well-controlled scientific study that supported their permanency claim.”

Id. Since the only substantiation evidence in that trial was a single experiment which, according to the doctor

who conducted it, did not actually demonstrate permanent hair removal, the respondent's substantiation was

found to be inadequate. Id. Removatron, therefore, is consistent with the requirement that the appropriate level of

substantiation is determined by the evidence, and does not hold that RCTs are required as a general matter.

*199 Additionally, in another case relied upon by Complaint Counsel, Thompson Medical 1984 FTC LEXIS

6, which involved an arthritis medication, Aspercreme, the Commission evaluated the efficacy of an over-thecounter analgesic drug, utilizing the six Pfizer factors, to conclude that the proper level of substantiation was

two well-controlled clinical tests. 1984 FTC LEXIS 6 at *291, 398. However, there the Commission also noted,
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“we do not preclude ourselves from also permitting advertisers to use other types of evidence to comply with our

substantiation requirement.” Id. at *399.

Finally, Complaint Counsel relies on QT, Inc., 448 F. Supp. 2d at 961. In determining the appropriate level

of substantiation in that case, the court stated at the outset: “The Court must first determine what level of

substantiation Defendants were required to possess for [the claim that an ‘ionized’ bracelet was proven, by

scientific tests, to provide immediate pain relief]. This is a question of fact.” Id. (emphasis added). The expert

testimony in that case was that “at least one well-conducted, placebo-controlled, randomized, double-blind or

sham-controlled clinical trial would be required by qualified experts in the field of pain due to rheumatic disease to

support a claim that a product relieves or treats musculoskeletal pain,” and that “a placebo-controlled, randomized,

double-blind trial is the gold standard in the scientific community and depending on the claims an advertiser

wishes to make, such a gold-standard study should be attempted to support those claims.” Id. at 961-62. The court

concluded that “with medical, health-related claims, a well-conducted, placebo-controlled, randomized, doubleblind study, the gold standard, should have been conducted.” Id. at 962. On appeal, the court expressly rejected

the notion that RCTs are required as matter of law, stating: “Placebo-controlled, double-blind testing is not a legal

requirement for consumer products.” QT, Inc., 512 F.3d at 861. Thus, QT does not stand for the proposition that

RCTs are necessarily required, but is consistent with the proposition that the appropriate level of substantiation is

determined by what the evidence shows that experts in the relevant field would deem adequate.

b. Summary of expert testimony on the appropriate level of substantiation

Detailed findings of fact on the expert testimony adduced at trial on the appropriate level of substantiation

are set forth in Section II.F, supra. In summary, Complaint Counsel's experts in the fields of antioxidants and

epidemiology (Dr. Meir Stampfer), heart disease (Dr. Frank Sacks), prostate cancer (Dr. James Eastham), and

erectile dysfunction (Dr. Arnold Melman) each separately opined on the level of substantiation they would expect,

as experts in their respective fields, to support claims that the POM Products treat, prevent, or reduce the risk of

heart disease, prostate cancer, or erectile dysfunction, and claims that Respondents' clinical research proves such

benefits. These experts all testified that well-designed, well-conducted RCTs showing statistically and clinically

significant improvements in valid endpoints are necessary to make claims that: (1) the Challenged Products treat,

prevent, or reduce the risk of heart disease, prostate cancer, and/or erectile dysfunction; or (2) studies show that the

Challenged Products treat, prevent, or reduce the risk of heart disease, prostate cancer, and/or erectile dysfunction.

F. 626, 638, 648, 654.

*200 Respondents' experts in the fields of the design of clinical research protocols (Dr. Denis Miller), nutrition

(Dr. David Heber), cardiovascular health (Dr. Dean Ornish), urology and prostate health (Dr. Jean deKernion),

and urology and sexual medicine (Dr. Arthur Burnett and Dr. Irwin Goldstein) offered rebuttal to Complaint

Counsel's experts' testimony. Dr. Miller testified that Respondents do not need RCTs to substantiate POM's claims

because the POM Products are absolutely safe, pure fruit products and Respondents have not suggested that the

Challenged Products be used as substitutes for conventional medical treatment. F. 661; see also F. 662-670. Dr.

Heber opined that experts in nutrition evaluate whether competent and reliable science supports health claims for

safe, pure fruit products, such as pomegranate juice, based on the totality of evidence, which does not necessarily

include RCTs. F. 671-673. Dr. Ornish testified that, in a nutritional context, in vitro and animal studies may be

more effective in testing the efficacy of a nutrient and that the totality of Respondents' scientific evidence must

be considered in evaluating cardiovascular health claims, which need not be substantiated by expensive RCTs. F.

674; see also F. 675-679. Dr. deKernion testified that in the case of a fruit juice, which has low or no toxicity, it is

not necessary to use an RCT. F. 682. Dr. Burnett opined that a safe pure fruit juice, like pomegranate juice, which

is not used as a substitute for proper medical treatment, does not require RCTs to substantiate health claims. F.

683. Dr. Goldstein testified that RCT studies are not required to substantiate claims that pomegranate juice can

aid in erectile health. F. 685-686.
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c. Overview as to the appropriate level of substantiation

i. Expert testimony does not establish that RCTs are required in this case

The expert testimony in this case demonstrates that competent and reliable scientific evidence is required for claims

about nutritional supplements when such products are advertised to treat diseases or medical conditions. E.g., F.

662, 711, 964. See also Daniel Chapter One, 2009 FTC LEXIS 157, at *233-35 (Initial Decision) (summarizing

expert testimony and citing Natural Solution, 2007 U.S. Dist. LEXIS 60783, at *11-12; National Urological

Group, 645 F. Supp. 2d at 1190;Direct Marketing Concepts, 569 F. Supp. 2d at 300, 303). The greater weight of

the persuasive expert testimony adduced at trial does not, however, support Complaint Counsel's position that, in

order to have the required competent and reliable scientific evidence, Respondents must have had RCTs. F. 706,

707. Instead, the more persuasive expert testimony shows that RCTs are needed for a nutrient supplement if one

makes a claim that the product causes the effect of treating, preventing, or reducing the risk of a disease and one

offers the nutrient supplement as a replacement to medical care to treat, prevent, or reduce the risk of diseases.

F. 706. The evidence further shows that RCTs are not required to convey information about a food or nutrient

supplement where, as here, the safety of the product is known; the product creates no material risk of harm; and

the product is not being advocated as an alternative to following medical advice. F. 707.

ii. Expert testimony on the appropriate level of substantiation

*201 Having determined that RCTs are not required in this case, the next step is to determine what level of

substantiation Respondents were required to have for their advertising claims. QT, Inc., 448 F. Supp. 2d at 959.

As stated above, for efficacy claims, the appropriate level is determined by weighing the six Pfizer factors, one

of which is “the amount of substantiation experts in the field would agree is reasonable.” Thompson Medical,

1984 FTC LEXIS 6, at *387. For establishment claims, the appropriate level of substantiation is determined by

what would “satisfy the relevant scientific community that the claim[s are] true.” Removatron, 111 F.T.C. at *246,

1985 FTC LEXIS 21 at *195.

As asserted by Complaint Counsel, by virtue of their very nature, the advertisements containing establishment

claims also make the efficacy claims that are challenged as unsubstantiated in the Complaint. CCB at 31. Experts

in the relevant scientific communities would require the same level of evidence to support claims that a product

treats, prevents, or reduces the risk of a disease or dysfunction, as they would require to support claims that clinical

studies, research, or trials prove the same claims. E.g., F. 713. All four of Complaint Counsel's experts in the

relevant fields applied the same standards in evaluating Respondents' level of substantiation without regard to

whether the claims at issue were “clinically proven” establishment claims or whether the claims at issue were

efficacy claims without reference to any studies. E.g., F. 190, 199, 207, 214. As discussed below, the experts,

including Complaint Counsel's experts, considered evidence relating to the nature of the product, the nature of

the claim, and the feasibility of conducting RCTs. See F. 688-705. Thus, while application of the Pfizer factors

is not necessarily required, because the experts considered essentially the same factors in determining the “proof

sufficient to satisfy the relevant scientific community of the claim's truth” (Removatron, 1985 FTC LEXIS 21 at

*190), and because, with respect to Respondents' heart disease claims, Respondents did make non-establishment

claims, a review of the Pfizer factors is appropriate.

Under Pfizer, “the amount of substantiation experts in the field would agree is reasonable,” is one of six factors that

must be evaluated to determine the appropriate level of substantiation for non-establishment claims. Thompson

Medical, 1984 FTC LEXIS 6, at *387. That evaluation is discussed in the three subsequent sections of the Initial

Decision specific to what experts in each of the relevant fields believe to be reasonable substantiation for claims

regarding heart disease, prostate cancer, and erectile dysfunction, respectively. The remaining five Pfizer factors
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are applicable in determining the required level of substantiation regardless of the relevant field, and are, therefore,

addressed below as a preliminary matter, before the evaluation of the evidence on what experts in the fields of

heart disease, prostate cancer, and erectile dysfunction would agree is reasonable substantiation. Those five Pfizer

factors, analyzed below, are: (1) the products involved; (2) the type of claim; (3) the benefits of a truthful claim; (4)

the ease of developing substantiation for the claim; and (5) the consequences of a false claim. Thompson Medical,

1984 FTC LEXIS 6, at *387.

(a) The products involved

*202 The POM Products are either food products or dietary supplements wholly derived from the pomegranate

fruit. F. 57-58, 61, 67, 70-71. POM Juice is produced by pressing the whole fruit containing both arils (pomegranate

berries) and the peel (husk) and internal membrane. F. 57-58. POMx is an extract from the pomegranate, made

through a process by which POMx Liquid is first derived from the whole fruit, and then POMx is extracted from

the POMx Liquid. F. 67, 70. POM Juice is sold in the refrigerated produce section of grocery stores. F. 65.

Pomegranate juice and its extract have a “high degree” of safety and are safe for human consumption. F. 78.

Humans have consumed pomegranates for centuries as a safe and nutritious food. F. 77. The U.S. Food and Drug

Administration (“FDA”) identifies pomegranate as being “generally recognized as safe” for human consumption.

F. 82, 84; see 32 U.S.C. § 231(s). To establish such recognition, it must be shown that there is a consensus of

expert opinion regarding the safety of the use of the substance. 21 C.F.R. § 170.30(a); see F. 83. Respondents'

expert, Dr. Heber, confirmed that pomegranate juice has no adverse side effects, in contrast to drugs. F. 85-88.

Complaint Counsel's expert, Dr. Sacks, testified that the issue of the safety of the POM Products was not within the

scope of his assignment in this case, that his expert report contains no opinions on the safety of the POM Products,

and that he has “no opinion about whether [the POM Products are] safe or not.” F. 93. Complaint Counsel's expert,

Dr. Stampfer, admitted that there are no safety concerns with consuming pomegranate juice apart from “the usual

harm that comes with fruit juice, sugary beverages ... but that is not specific to pomegranate juice.” F. 94.

Scientific studies also confirm that POM Juice and POMx are safe for human consumption. F. 87, 88. Researchers

validated the safety of POMx Pills in a clinical study where no adverse events or changes in blood count, serum

chemistry or urinalysis were observed in the human subjects after consuming the extract for four weeks. F. 92.

Researchers confirmed in a clinical study that the consumption of pomegranate juice had no drug interaction in

the human volunteers. F. 91.

Complaint Counsel's experts agreed that the level of scientific evidence required to support a claim considers the

product being promoted. F. 695. The greater weight of the persuasive expert testimony is that RCTs are needed

for pharmaceutical drugs to assess safety and efficacy because pharmaceutical drugs are unnatural, developed in

laboratories, and have toxicities. F. 666, 675, 682, 686, 696. Pharmaceutical drugs, which are not known to be

safe and always have toxicities and side effects, are held to a higher standard than a juice that is derived from

a fruit that has been around for thousands of years. F. 666, 675, 682, 686, 697. Complaint Counsel's expert,

Dr. Sacks, testified that you do not need RCT trials to test the benefit of food categories that are included in a

diet already tested, like the DASH diet, which includes pomegranates. F. 645. Complaint Counsel's expert, Dr.

Stampfer, conceded that RCTs are not required (or better) for nutritional-based research and admitted that he has

made public statements or recommendations that food and beverage products lower the risk of certain diseases

in the absence of RCTs. F. 631, 632.

*203 The standard applied to new drugs should not be applied to nutrients as long as the product is not claimed

to be a substitute for conventional drug therapies or medical care and is shown to be safe. F. 666, 682, 697, 698.
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Thus, the facts that the POM Products are derived from a fruit and are known to be safe weigh in favor of a

standard for substantiation that is less than that required for pharmaceutical drugs.

(b) The type of claim

The type of claim Respondents have been found to have made — that the POM Products treat, prevent, or reduce

the risk of heart disease, prostate cancer, or erectile dysfunction and that the POM Products are clinically proven to

do so — weighs in favor of a high standard for substantiation. Where defendants make a “medical, health-related

claim, ... such a claim must be based on a heightened level of substantiation.” QT, 448 F. Supp. 2d at 962. In

QT, where the expert testimony established that “a well-conducted, placebo-controlled, randomized, double-blind

study, the gold standard, should have been conducted,” the court held that “Defendants would not be required to

have a gold-standard study to substantiate the Q-Ray bracelet if they did not make such a strong, medical claim.”

QT, 448 F. Supp. 2d at 962. In addition, where defendants claim that a product's efficacy has been “test-proven,”

such a statement must be substantiated by “a reliable test” with “statistically significant results achieved.” QT, 512

F.3d at 862;Removatron, 884 F.2d at 1498 (“reasonable basis” for establishment claims meant well-controlled

scientific studies).

While Respondents here have been found to have made claims that the POM Products treat, prevent, or reduce

the risk of diseases or dysfunction, it is significant to note that Respondents did not advertise or market the POM

Products as an alternative to medical treatment. “The Complaint does not allege, and it is neither Complaint

Counsel's contention nor its burden, to demonstrate that Respondents are selling the POM Products as a substitute

for conventional medical treatment.” CCRB at 40 n.36.

The greater weight of the persuasive expert testimony in this case confirms that the appropriate level of

substantiation depends on the claims. If the claim does not suggest that an individual should forgo conventional

medical care or treatment based on the consumption of a safe product and does not imply that a causal link

between the product and the effect has been established, then evidence short of RCTs can be sufficient. F. 631, 707.

Complaint Counsel's expert, Dr. Stampfer, testified that if, for example, nuts are not being offered as a substitute

to medical care, and the claim is that there is some evidence to suggest the possibility that nuts may reduce the

risk of diabetes, then evidence short of RCTs can support that claim. F. 631. While claims of efficacy can be made

only when a causal relationship with human disease is established by competent and reliable scientific evidence

(F. 627; see also F. 629-631), based on the evidence and the law as applied to this case, competent and reliable

scientific evidence does not mean RCTs.

(c) The benefits of a truthful claim and the ease of developing substantiation for the claim

*204 “These two factors -- the benefits of a truthful claim and the ease of developing substantiation for the claim

-- are typically considered together.” Daniel Chapter One, 2009 FTC LEXIS 157, at *232-33 (Initial Decision).

“The consideration of these factors seeks to ensure that the level of substantiation required is not likely to deter

product development or prevent disclosure of potentially valuable information about product characteristics to

consumers.” Id. at *233 (citing Removatron, 1985 FTC LEXIS 21, at *212 n.20; Thompson Medical, 104 F.T.C.

at 823-24, 1984 FTC LEXIS 6, at *391).

The fact that individuals could benefit from truthful claims about a product's ability to treat, prevent, or reduce

the risk of diseases or medical conditions is obvious. Complaint Counsel's expert, Dr. Stampfer, conceded that he

“believe [s] that it may be appropriate to use evidence short of an RCT for crafting public health recommendations

regarding nutrient guidelines even when causality cannot be established, because everyone eats and the public

should be given advice based on the best evidence available.” F. 631. Dr. Stampfer further testified that the

failure to act, in the absence of conclusive RCT evidence, increases the risk of forgoing benefits to the public
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that might have been achieved with little risk and little cost and that one should “definitely” make that potential

benefit available to the public rather than withhold it. F. 633. Although advertising is not a “public health

recommendation,” it does convey a message and provides “potentially valuable information” about products.

Thompson Medical, 1984 FTC LEXIS 6, at *391.

In a nutritional context, RCTs are prohibitively expensive and often not feasible because of the costs of conducting

them. F. 632, 647, 673, 704. Complaint Counsel's expert, Dr. Eastham, testified that disease prevention studies

should involve ten to thirty thousand participants which are “incredibly expensive” and in the range of $600

million. F. 704. Foods, unlike pharmaceutical drugs, are not patentable, and manufacturers cannot recoup the costs

of conducting RCTs through profits from exclusive intellectual property rights. F. 705.

Complaint Counsel's expert, Dr. Sacks, acknowledged that RCTs may also not be feasible because of logistical

and ethical considerations. F. 641, 704. In studying a fruit or food, it is difficult to do double-blind, randomized,

placebo-controlled trials because the subjects know what they are consuming. F. 641, 679, 703. Once a participant

is assigned to the control group and they know what the intervention is, the participant can consume the food

or juice anyway, whereas one would not be able to do so with an experimental drug. F. 703. Moreover, in a

nutritional context, a hypothesis about disease causation can rarely, if ever, be directly tested in humans using

the RCT design. F. 701.

*205 The greater weight of the persuasive expert testimony in this case leads to the conclusion that where the

product is absolutely safe, like the POM Products, and where the claim or advertisement does not suggest that the

product be used as a substitute for conventional medical care or treatment, then it is appropriate to favor disclosure.

See F. 633, 709; see also Pearson, 164 F.3d at 657 (under the First Amendment commercial speech doctrine, there

is a “preference for disclosure over outright suppression”).

(d) The consequences of a false claim

The consequences of a false claim do not compel requiring a high level of substantiation. As analyzed above,

there is no evidence to suggest, and Complaint Counsel does not argue, that Respondents urge individuals to

consume the POM Products in place of conventional medical treatment. CCRB at 40 n.36. Compare Daniel

Chapter One, 2009 FTC LEXIS 157, at *234, *282 (Initial Decision) (finding that where representations in some

instances suggested that individuals forego traditional cancer treatments in favor of purchasing and consuming

the challenged products and evidence showed that foregoing a proven cancer treatment in favor of an ineffective

treatment would be injurious to a patient's health, the consequences of a false claim required a higher level of

substantiation). Moreover, the evidence shows that the POM Products are safe. F. 77-78. See also F. 94.

In Pearson v. Shalala, 164 F.3d 650, 656 n.6 (D.C. Cir. 1999), the court of appeals explained that courts should

distinguish between products (e.g., dietary supplements) that do not “in any fashion threaten consumer's health

and safety” and “drugs,” “wherein the potential harm presumably is much greater,” when evaluating restrictions

on commercial speech. The court in Whitaker v. Thompson, 248 F. Supp. 2d 1 (D.D.C. 2002) further explained:

It is especially important to recognize that, in the present case, the potential harm to consumers from deception is

severely limited ... At worst any deception resulting from Plaintiffs' health claim will result in consumers spending

money on a product that they might not otherwise have purchased.

Id. at 16 (noting also that the economic injury is not insignificant).

Spending money on an ineffective remedy is considered an economic injury for purposes of this Pfizer factor.

Daniel Chapter One, 2009 FTC LEXIS 157, at *234 (Initial Decision) (citing In re Schering Corp., No. 9232,

1991 FTC LEXIS 427, at *134 (Sept. 16, 1991)); Removatron, 1985 FTC LEXIS 21, at *212 n.20). In this case,
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for the 52 weeks ending July 20, 2008, the weighted average base price per unit for POM Juice was $2.93 for

an 8-ounce bottle or $4.29 for a 16-ounce bottle. F. 97. A serving size of POM Juice is eight ounces and, thus, a

one year supply costs at least $780. See F. 64, 97. A one year supply of POMx costs approximately $315. See F.

97. Although the cost of the POM Products may not be insignificant, when you take into account the fact, at least

with respect to POM Juice, that consumers are buying what is considered to be a premium fruit juice (F. 95), the

economic injury to consumers is not a material factor in determining the required level of substantiation.

(e) The amount of substantiation experts in the field would agree is reasonable

*206 The last of the six Pfizer factors, the amount of substantiation experts in the field would agree is reasonable,

must be examined in relation to each field being evaluated. In addition, for Respondents' claims that were

establishment claims only, Respondents must “satisfy the relevant scientific community that the claim is true.”

Removatron, 1985 FTC LEXIS 21, at *195. Accordingly, the amount of substantiation experts would agree is

reasonable, the amount of evidence that would satisfy the relevant scientific community, and whether Respondents

possessed that level of substantiation in regard to each of the three diseases or dysfunction, is evaluated in the

following three sections of the Initial Decision.

3. Substantiation for Respondents' heart disease claims

a. Overview

As discussed in Section III.E.2.c, supra, the evidence demonstrates that Respondents disseminated advertisements

that impliedly represented that the POM Products treat, prevent, or reduce the risk of heart disease and, in many

of these same advertisements, are clinically proven to do so, by lowering blood pressure, reducing arterial plaque

and/or increasing blood flow to the heart. Complaint Counsel contends that (1) Respondents did not possess and

rely upon a reasonable basis to substantiate their efficacy claims that the POM Products treat, prevent, or reduce

the risk of heart disease; and (2) clinical studies, research, and/or trials do not prove Respondents' establishment

claims that the POM Products treat, prevent, or reduce the risk of heart disease. CCB at 37-44.

i. Summary of expert opinions

In support of its position, Complaint Counsel submitted the expert report and testimony of Dr. Meir Stampfer and

Dr. Frank Sacks. Dr. Stampfer is a Professor of Epidemiology and Nutrition, Harvard School of Public Health;

Faculty Member, Division of Biological Sciences, Harvard School of Public Health; Professor of Medicine,

Harvard Medical School; and Faculty Member, Dana Farber Harvard Cancer Center. F. 182. Dr. Stampfer has

been an investigator in several large studies focused on the relationship between nutrition and cardiovascular

disease and has published more than 850 articles in medical journals. F. 183, 184. Dr. Sacks is a Professor of

Cardiovascular Disease Prevention, Department of Nutrition, Harvard School of Public Health, and Professor

of Medicine, Harvard Medical School. F. 191. Dr. Sacks has researched cardiovascular disease (“CVD”) and

coronary heart disease (“CHD”) and their risk factors, including lipid profiles, hypertension, obesity, and diabetes,

and the effects of potential risk-modifying diets, foods, food components, and drugs. F. 192. Dr. Sacks has

published more than 160 articles in peer-reviewed scientific journals relating to CVD, CHD, and the relationship

between nutrition and these diseases. F. 193.

*207 According to Dr. Stampfer, for products such as the POM Products, claims of efficacy can be made only

when a causal relationship with human disease has been established and the RCT is the best study design that

permits a strong causal inference concerning the relationship between an administered agent and any specific

outcome. F. 631, 632. According to Dr. Sacks, to substantiate a claim that a product, including a conventional

food or dietary supplement, can treat, prevent, or reduce the risk of heart disease, one must rely on appropriately
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analyzed results of well-designed, well-conducted RCTs. F. 638. Dr. Sacks further opined that the findings of

the RCTs must be statistically significant (i.e., have strong “p” values). F. 711. In addition, Dr. Sacks opined

that the results of the RCTs must demonstrate significant changes in valid surrogate markers of cardiovascular

health, such as blood pressure and LDL cholesterol (two surrogate markers recognized by the FDA) or Creactive

protein, HDL cholesterol, and triglycerides (three surrogate markers recognized by many experts in the field). F.

712, 761-763, 765-766.

In Dr. Sacks' opinion, the same level of evidence is needed to show that clinical studies, research, or trials prove

that a product treats, prevents, reduces the risk of heart disease, as is needed to substantiate a heart disease efficacy

claim. F. 713.

Dr. Sacks acknowledged that there are common clinical recommendations today that have not been proven by

RCTs, that in some instances, such as studies on foods, the blinding of patients is not possible, and that if a study

becomes unblinded or does not have a placebo, the study can still have value. F. 641, 647. Moreover, Dr. Sacks

testified that you do not need RCTs to test the benefit of food categories that are included in a diet already tested,

like the DASH diet, which includes pomegranates. F. 645. These positions weaken Dr. Sacks' opinion in this case

that Respondents must have had two RCTs to support their claims.

In support of their position that they possessed and relied upon a reasonable basis to substantiate their claims,

Respondents submitted the expert reports and testimony of Dr. David Heber and Dr. Dean Ornish. Dr. David

Heber is a practicing physician, Professor of Medicine and Public Health at UCLA, and the founding Director of

the UCLA Center for Human Nutrition, a center for clinical research, education, and public health endeavors. F.

221, 222. Dr. Heber has co-authored over 200 peer-reviewed publications in the field of nutrition and its relation

to various diseases and written 25 chapters in other scientific texts. F. 224. Dr. Ornish is a well-known medical

doctor and Clinical Professor of Medicine at the University of California at San Francisco. F. 227. Dr. Ornish

is also the founder and President of the Preventative Medicine Research Institute (“PMRI”). F. 228. Dr. Ornish

has directed clinical research on the relationship between diet and lifestyle and coronary heart disease for over 34

years and has written numerous books and articles for peer-reviewed journals. F. 229, 230.

*208 Both Dr. Heber and Dr. Ornish opined that there is credible scientific evidence showing that pomegranate

juice and pomegranate extracts have significant health benefits for human cardiovascular systems, including: (1)

decreases in arterial plaque; (2) lowering of blood pressure; and (3) improvement in cardiac blood flow, based

on the biological mechanism of prolonging the half-life of nitric oxide in the vasculature. F. 956, 960. Dr. Ornish

opined that, taken as a whole, the preponderance of the scientific evidence from basic scientific studies, animal

research, and clinical trials in humans reveals that the pomegranate in its various forms (including POM Wonderful

100% Pomegranate Juice, POMx Pills, or POMx Liquid) is likely to be beneficial in maintaining cardiovascular

health and is likely to help reduce the risk of cardiovascular disease. F. 959. Dr. Heber also opined that the body

of research on pomegranate juice and extract provides support for potential heart benefits for heart disease. F.

954. Dr. Heber explained that although claims that pomegranate juice and extract have not been proven absolutely

effective to treat, prevent, or reduce the risk of heart disease, the entire body of scientific evidence should be

considered when evaluating nutritional science. F. 957.

Dr. Ornish disagreed that study results must be “statistically significant” with “strong ‘p’ values” (i.e., p # 0.05

or a 5 percent or less chance that the change is due to chance), testifying that: (1) in evaluating scientific research

related to a whole food, it is not necessary to reach statistical significance, as opposed to a prescription drug with

potential side effects; and (2) the convention that there be a five percent or less finding due to chance is an arbitrary

number. F. 958. Respondents' experts further dispute Dr. Sacks' opinion that significant changes must be shown

in valid surrogate markers and opine that myocardial perfusion (or blood flow to the heart) and carotid intima-
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media thickness are more closely related to, and predictive of, cardiovascular disease than blood pressure or LDL

cholesterol. F. 764, 765, 771.

ii. Standard for substantiation

Having considered the evidence on all the relevant factors, including the other five Pfizer factors analyzed in

Section III.F.2, supra, the evidence demonstrates that competent and reliable scientific evidence is required to

support claims that the POM Products treat, prevent, or reduce the risk of heart disease and that they have been

clinically proven to do so. F. 711, 713; see also F. 710, 712. Based on the greater weight of the persuasive evidence

from the experts at trial, to support claims that the POM Products treat, prevent, or reduce the risk of heart disease,

or have been clinically proven to do so, competent and reliable evidence must include clinical studies, although not

necessarily RCTs, that show that the POM Products did treat, prevent, or reduce the risk of heart disease. See id.

As analyzed below, Complaint Counsel has demonstrated that Respondents did not possess adequate competent

and reliable scientific evidence to substantiate the implied claims that the POM Products treat, prevent, or reduce

the risk of heart disease or that clinical tests show the same. Complaint Counsel has, therefore, met its burden of

proving that Respondents' claims are false or misleading. See QT, 448 F. Supp. 2d at 959.

b. Scientific evidence relied upon

i. Overview of cardiovascular heart disease

*209 Heart disease, including heart attacks or angina, occurs as the result of decades-long damage to blood

vessels. F. 715, 716. The process begins with the oxidation of the protein known as low density lipoprotein (“LDL”

or bad cholesterol) which circulates in the blood. F. 716. Once LDL becomes oxidized, the chemical nature of the

protein changes, causing it to reside and accumulate in the blood vessel. F. 717. Macrophages, white blood cells

that respond to inflammation by digesting cellular debris, begin to engulf and devour the oxidized cholesterol. F.

719. These macrophages continue to accumulate until they develop into “foam cells.” F. 720. These foam cells

become full of cholesterol and actually burst, bringing in more macrophages and more inflammation. F. 720. As

this process progresses, plaque begins to form as yellow streaks in the coronary arteries. F. 721.

Antioxidants play an important role in mitigating heart disease by, among other things, inhibiting oxidative stress,

including reducing LDL oxidation (and its uptake) and inflammation. F. 726, 727. In addition, the presence of nitric

oxide in the body also helps offer protection against atherosclerosis by regulating blood flow and contributing to

smooth muscle relaxation. F. 723-725, 751. Nitric oxide helps maintain healthy blood vessels, which improves

blood flow to almost every organ in the body, including the heart. F. 731. Several studies have indicated that

pomegranate juice has antioxidant and anti-atherosclerotic properties due to the presence of multiple polyphenols

such as tannins, flavonols, anthocyanins and ellagic acid. F. 725.

ii. In vitro and in vivo studies

Respondents sponsored several in vitro and in vivo animal studies to examine the effect of POM Juice and POMx

Pills on cardiovascular health. In vitro studies are those where blood elements or cells are removed from the

body and tested in a controlled laboratory environment, such as a test tube. F. 593. In vivo studies are those

conducted within the living. Respondents acknowledge that their in vitro and in vivo studies are “basic science”

or “pre-clinical.” RRCCFF 1083. Detailed findings on these studies are set forth in Section II.G.3, supra, and are

summarized below.

Respondents have sponsored many published studies in cellular and animal models evaluating the effects of

pomegranate juice and/or its extracts on cardiovascular function. F. 732. Beginning around 2000, and continuing
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to the present time, Dr. Michael Aviram began studies investigating pomegranate juice's potential benefits to the

cardiovascular system. F. 744. Dr. Aviram and his colleagues observed several beneficial effects of pomegranate

juice and its extracts at the cellular and animal stage including, but not limited to: (1) reduction in oxidation of

LDL cholesterol; (2) lessening the “uptake” of oxidized LDL by macrophage foam cells; (3) decrease in size of

atherosclerotic lesions and foam cells; and (4) diminishing of platelet aggregation. F. 744.

*210 Respondents have also sponsored research in the area of nitric oxide and understanding its role in

cardiovascular health in vitro and in animals. F. 747. Dr. deNigris, Dr. Napoli, and, Dr. Ignarro conducted a number

of studies in which they found that POM Juice and/or POMx Pills demonstrated: increasing and preserving levels

of nitric oxide, decreasing expression of genes associated with stress, and progression of atherosclerosis; reducing

LDL oxidation, size of atherosclerotic plaques, and formation of foam cells; reversing effects of shear stress,

which can damage the endothelial cells or thin layer of cells that line the interior of blood vessels; decreasing

cellular production and release of oxygen radicals in the vascular wall; inhibiting activation of oxidation-sensitive

genes; and improving biological activity of nitric oxide. F. 751.

Complaint Counsel's expert, Dr. Sacks, acknowledges that some of Respondents' in vitro studies have shown

pomegranate juice's favorable effects on the mechanisms involved in cardiovascular disease and that in vitro

studies, like Dr. Aviram's, can be competent and reliable scientific evidence of an agent's effect on a particular

mechanism. F. 745, 746. However, Dr. Sacks also opined regarding Respondents' basic research that in vitro and

animal studies do not provide reliable scientific evidence of what effects a treatment will have inside the human

body and, thus, do not provide reliable scientific evidence on whether an agent can treat, prevent or reduce the risk

of cardiovascular disease in humans. F. 752. Respondents' expert, Dr. Ornish, testified that in vitro and animal

studies are important in considering the totality of evidence in determining whether or not pomegranate juice in

its various forms is beneficial, but that there are limitations to extrapolating from in vitro and animal studies to

humans. F. 753.

Respondents' basic science indicates that pomegranate juice may be beneficial to cardiovascular health. F. 754. The

basic research relied upon by Respondents is part of the totality of evidence that must be examined in evaluating

the effects of the POM Products. F. 755. However, experts in the field agree that in vitro and animal studies need

to be replicated in humans to show an effect on preventing or treating a disease. F. 755.

iii. Clinical trials; overview

Complaint Counsel charges that Respondents did not have a reasonable basis and did not have clinical studies,

research, or trials to prove that the POM Products prevent, reduce the risk of, or treat heart disease, by: (1) lowering

blood pressure; (2) decreasing arterial plaque; and/or (3) improving blood flow to the heart. (Complaint ¶¶ 17-19).

Respondents have sponsored approximately 10 published and several unpublished studies on humans, evaluating

the effect of pomegranate juice and/or its extracts on cardiovascular health. F. 756. The results of the studies relied

upon by Respondents and the conflicting expert opinions on these studies are found in Section II.G.5, supra, and

discussed below.

iv. Clinical trials; improving blood pressure

*211 In support of claims that the POM Products treat, prevent, or reduce the risk of heart disease by lowering

blood pressure, in addition to the basic science discussed above, Respondents rely on the Aviram ACE/BP Study 10

and the Aviram CIMT/BP Study 11 of POM Juice. RRB at 106.

(a) About the studies
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The Aviram ACE/BP Study was a study with ten elderly, hypertensive patients who drank 50 ml. of pomegranate

concentrate daily, for two weeks. F. 774. The Aviram ACE/BP Study was unblinded and had no control group;

instead, each patient's “before” measures were compared to his or her “after” measures. F. 776. The Aviram

ACE/BP Study indicated that all ten patients experienced a statistically significant 5% reduction in systolic

blood pressure from their baseline blood pressure measure. F. 778. The Aviram ACE/BP Study concluded that

“pomegranate juice consumption can offer a wide protection against cardiovascular disease.” F. 779.

In the Aviram CIMT/BP Study, a group of ten patients with severe carotid artery stenosis consumed 50 ml. of

concentrated pomegranate juice daily for one year and five of them continued for up to three years. F. 790. A

second group of nine patients who did not consume pomegranate juice acted as a control. F. 790. The Aviram

CIMT/BP Study indicated that the pomegranate juice group members' systolic blood pressure was significantly

(p < 0.05) reduced by 12% after one year of pomegranate juice consumption, compared to their baseline values.

F. 794. In the group that did not consume pomegranate juice, blood pressure was unchanged. F. 794.

(b) Expert opinions on the studies

Complaint Counsel's experts criticized the Aviram ACE/BP Study on the following grounds: the sample size of

ten patients was too small to provide reliable evidence that the observed effects would be generally applicable to

a larger population; the two-week period of the study was too short to provide reliable evidence that the indicated

improvement in blood pressure would be enduring; and the Aviram ACE/BP Study did not have a control group,

thus, it is not possible to conclude what caused the indicated improvements in the subjects' blood pressure levels.

F. 780. Complaint Counsel's experts criticized the Aviram CIMT/BP Study for the lack of a randomized, placebocontrolled group; the fact that the patients in the active and control groups received different treatment; the small

sample size; and the lack of any between-group statistical analysis. F. 798.

Respondents' expert, Dr. Ornish, responded that there is a common misconception that a larger study is a better

study, but the opposite can be argued; with a smaller number of patients, the treatment has to be more powerful

and consistent in order to show a statistically significant effect. F. 783, 803; see also F. 785. Dr. Aviram testified

that it is entirely appropriate for each patient to serve as his or her own control and that if a study is conducted

without a placebo, that fact does not weaken its importance. F. 784.

*212 Complaint Counsel's experts additionally opined that one cannot extrapolate the results of the two Aviram

studies of POM Juice to the POMx products. See F. 948. Respondents counter this criticism by stating that,

with respect to POMx Pills and POMx Liquid, Respondents detailed the findings of eight scientific studies

that document the beneficial effects of POMx Pills and POMx Liquid on cardiovascular health. RRCCFF 965

(citing CX0053; PX0057; PX0056; PX0008; PX0017; PX0038; PX0139; PX0127; RFF 831-840, 924, 930-957,

1100). Furthermore, Dr. Heber, the only expert who opined on the bioavailability of pomegranate polyphenols,

explained that because both the 100% Pomegranate Juice product and the POMx products contain ellagitannins

that contribute to the antioxidant activity of the products (and because both are bioavailable (absorbed) in humans),

there is no difference in the antioxidant effect between POM Juice and POMx products in laboratory studies. F.

953.

Lastly, Complaint Counsel charges that five subsequent RCTs sponsored by Respondents showed no benefit to

blood pressure. These include the Ornish MP Study; 12 the Ornish CIMT Study; 13 the Davidson BART/FMD

Study; 14 the Davidson CIMT Study; 15 and the San Diego Study. 16 Complaint Counsel's expert, Dr. Sacks,

opined that the Ornish CIMT Study's and the Davidson BART/FMD Study's findings of no statistically significant

difference in blood pressure due to POM Juice consumption undermine the credibility of the results of the Aviram

ACE/BP Study and Aviram CIMT/BP Study. F. 862, 909.
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Respondents counter this criticism by stating that none of Respondents' subsequent studies examined blood

pressure as a primary endpoint and, as a result, one cannot conclude that there was no effect of POM Juice or

POMx on blood pressure. RRB at 94; F. 864, 866, 912. In any clinical study, it is routine to record blood pressure,

pulse, body temperature, among other measurements, to make sure patients are healthy. F. 842. Although blood

pressure is measured in many studies, a specific claim on blood pressure requires a very specific study involving

special equipment and personnel. F. 842. Thus, Dr. Heber testified, where blood pressure was not the endpoint,

any results for blood pressure cannot be relied upon as negative evidence. F. 841, 912. Complaint Counsel's expert,

Dr. Sacks, concedes that in subsequent studies showing no statistically significant changes in blood pressure, the

absence of such evidence is not proof that there is no effect. F. 867, 911.

(c) Determination

As discussed above, the expert testimony regarding the Aviram ACE/BP Study and Aviram CIMT/BP Study

is conflicting. The greater weight of the persuasive expert testimony on the studies sponsored by Respondents

measuring blood pressure demonstrates that the scientific evidence relied upon by Respondents is not adequate

to substantiate a claim that the POM Products treat, prevent, or reduce the risk of heart disease through reducing

blood pressure, or that clinical studies show the same.

v. Clinical trials; reducing arterial plaque

(a) About the Aviram CIMT/BP Study

*213 In support of claims that the POM Products treat, prevent, or reduce the risk of heart disease by reducing

arterial plaque, in addition to the basic science discussed above, Respondents rely on the Aviram CIMT/BP Study

and the Davidson CIMT Study. RRB at 106.

Carotid intima media thickness (“CIMT”) testing measures the combination of the vessel muscle and

atherosclerosis (arterial plaque). F. 767. Measures of CIMT are usually relevant to cardiovascular health, and if

CIMT measures show consistent improvement, this would be an indicator that a treatment may be beneficial. F.

769. However, such measures alone are not conclusive evidence that an intervention treats existing heart disease.

F. 769.

In the Aviram CIMT/BP Study, a group of ten patients with severe carotid artery stenosis (“CAS”) consumed 50

ml. of concentrated pomegranate juice daily for one year and five of them continued for up to three years. F. 790. A

second group of nine patients who did not consume pomegranate juice acted as a control. F. 790. The results of the

Aviram CIMT/BP Study showed that, in the control group that did not consume pomegranate juice, the patients'

CIMT increased by 9% during one year, whereas, pomegranate juice consumption resulted in a significant CIMT

reduction, by up to 30%, after one year. F. 791. The Aviram CIMT/BP Study concluded that the “results of the

present study ... suggest that [pomegranate juice] consumption by patients with CAS decreases carotid IMT and

systolic blood pressure and these effects could be related to the potent antioxidant characteristics of [pomegranate

juice] polyphenols.” F. 797.

(b) Expert opinions on the Aviram CIMT/BP Study

Complaint Counsel's expert, Dr. Sacks, testified that a qualified scientist would not be able to conclude with any

credibility that the improvements in the treatment group indicated by the Aviram CIMT/BP Study were caused

by the group's consumption of pomegranate juice and not some other factor because of: the lack of a randomized,

placebo-controlled group; the fact that the patients in the active and control groups received different treatment;

the small sample size; and the lack of any between-group statistical analysis. F. 798.
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Dr. Ornish testified that the findings in the Aviram CIMT/BP Study suggest that oxidative stress may have been

reduced by pomegranate juice consumption in these patients. F. 793. Respondents assert that the fact that the

Aviram CIMT/BP Study is considered “unblinded and uncontrolled” by Complaint Counsel does not invalidate

the results. RRB at 95. However, Respondents' expert, Dr. Ornish, agreed that the Aviram CIMT/BP Study was

limited in scope and opined: “Thus, while not at all conclusive, the study suggests a benefit.” F. 802. He further

testified that the Aviram CIMT/BP Study was “very provocative and interesting and laid the groundwork for even

more conclusive studies.” F. 802.

(c) About the Davidson CIMT Study

*214 The Davidson CIMT Study was an 18-month, 289-person randomized, double-blinded, placebo-controlled

clinical trial conducted at two clinical research sites in accordance with good clinical practice guidelines and

under a protocol approved by an institutional review board. F. 872. Participants in the Davidson CIMT Study

drank eight ounces of pomegranate juice or placebo juice daily. F. 876. Adherence to product consumption was

assessed at each visit by reviewing daily consumption diaries maintained by the subjects. F. 876. The protocol

for the Davidson CIMT Study called for ultrasound testing of the carotid artery at baseline, at 12 months, and

at 18 months. F. 877.

Among other findings, the Davidson CIMT Study indicated the following:

• Anterior and posterior wall CIMT values and progression rates did not differ significantly between treatment

groups at any time point.

• The composite measurement of CIMT showed a significantly smaller value at 12 months in the pomegranate

juice group compared to the control group ... However, this difference was no longer significant at the end of the

treatment period [18 months].

• Results of the present study showed no significant influence of 18 months of pomegranate juice consumption

on CIMT progression in the overall study sample. However, results from post hoc exploratory analyses, which

should be interpreted with caution, suggest that the rate of CIMT progression may have been slowed in subgroups

characterized by more rapid CIMT progression, including those with increased levels of TG-rich lipoproteins, low

levels of HDL cholesterol, and greater oxidative stress.

• Whether possible benefits of pomegranate juice consumption on CIMT progression in some subgroups relate to

antioxidant activity is uncertain. A lack of significant improvements in most markers of oxidative stress argues

against an important role for antioxidant activity. However, specific reactive oxygen/nitrogen species may be

scavenged by pomegranate unique polyphenolic hydrolysable tannins. Indeed, a subgroup for whom there was

an apparent benefit was the top tertile for baseline PD — AAPH, suggesting that antioxidant effects may have

played a role in the protection against CIMT progression by pomegranate juice consumption.

F. 878.

(d) Expert opinions on the Davidson CIMT Study

Complaint Counsel charges that Respondents “cherry-picked observations from the Davidson CIMT Study” by,

inter alia, (1) relying on the results at 12 months, rather than the results at 18 months; and (2) focusing on results
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of an exploratory sub-group analysis performed post hoc. CCB at 38. Respondents rejoin that: (1) the fact that

differences in the composite measurement of CIMT were not statistically significant at 18 months does not change

the fact that these differences were statistically significant at 12 months; and (2) findings related to subgroups

cannot be ignored merely because they were formed in a post hoc analysis. RRB at 94-95.

*215 Complaint Counsel's expert, Dr. Sacks, testified that the Davidson CIMT Study is the largest of the heart

studies conducted on pomegranate juice; was carefully designed, in that the protocol identified the endpoints to

be measured, the procedures to be followed, inclusion and exclusion criteria, and the statistical analysis to be

conducted; and that there was no evidence of critical problems in the conduct or analysis of the study (except its

over-emphasis on the subgroup results). F. 884. Based on the findings of the Davidson CIMT Study (summarized

above), particularly that, at the end of the study, there were no significant differences in CIMT progression rates

between the subjects in the pomegranate juice and control groups, Dr. Sacks concluded that the Davidson CIMT

Study is “competent and reliable evidence that consumption of pomegranate juice did not improve CIMT in

subjects with one or more cardiovascular risk factors.” F. 884. Dr. Stampfer agreed and opined that that the main

result from the Davidson CIMT Study provides substantial evidence against the hypothesis that pomegranate juice

can reduce the progression of CIMT. F. 892.

Respondents' experts opine that the Davidson CIMT Study constitutes competent and reliable scientific evidence

that the consumption of POM Juice is beneficial to cardiovascular health by, among other things, reducing arterial

plaque. F. 885. Dr. Ornish stated that the bottom line of the Davidson CIMT Study is that pomegranate juice did

show a statistically significant improvement in CIMT after 12 months in the measure that was most clinically

relevant; the fact that these differences in CIMT measurements were not statistically significant at 18 months does

not change the fact that these differences were statistically significant after 12 months. F. 888.

Dr. Ornish explained that a potential reason for lack of a change in the CIMT progression rate at 18 months

was that participants in the Davidson CIMT Study may have stopped drinking the juice after 12 months. F. 890.

Dr. Ornish observed that it is not unusual for patients to be less than honest in describing their compliance, as

patients often describe that it is embarrassing and even humiliating to report that they have not done what they

were supposed to do. F. 890. However, Dr. Davidson, who evaluated compliance with the product consumption

guidelines during the Davidson CIMT Study, testified that his review of compliance diaries showed high levels

of compliance with the product consumption guidelines. F. 891.

Respondents' experts also opine that the Davidson CIMT Study provides supporting evidence that there were

statistically significant lower CIMT progression rates for pomegranate versus control in the subgroup of persons

with higher cardiovascular disease risk factors. F. 888. The Davidson CIMT Study described the subgroup analyses

as “post hoc exploratory analyses, which should be interpreted with caution[.]” F. 878. Respondents' experts

opined that in scientific research, post hoc analysis is routine. F. 896.

*216 Complaint Counsel's expert, Dr. Sacks, opined that a post hoc analysis is one that is conceived after the

researchers have seen the data and is, thus, generally a less valid approach than one planned for in the protocol,

because it is more subject to bias. F. 895. Dr. Sacks further opined: because the subgroup data is hypothesis

generating only, and has not been corrected for multiple comparisons, a qualified scientist could not rely on the

post hoc analysis of the subgroup populations as reliable scientific evidence to support claims that POM Juice or

POMx prevent, reduce the risk of, or treat heart disease in the subgroup populations identified. F. 899.

(e) The Ornish CIMT Study

Complaint Counsel further charges that Respondents, in making claims that the POM Products can treat or prevent

heart disease by reducing arterial plaque, discount the outcome of the Ornish CIMT Study. CCB at 38. The Ornish
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CIMT Study was an unpublished, randomized, double-blind, placebo-controlled 73-person study, conducted by

Dr. Ornish, one of Respondents' experts in this case. F. 850. The primary endpoint of the Ornish CIMT Study was

to investigate the effects of pomegranate juice on CIMT in patients with at least one cardiovascular risk factor. F.

850. The treatment group drank eight ounces of pomegranate juice concentrate daily, and the control group drank

eight ounces of placebo beverage daily, for one year. F. 850. According to the Ornish CIMT Study unpublished

final report, there were no significant changes in the treatment group relative to the placebo for CIMT thickness

or elastic properties. F. 858.

Dr. Sacks described the results of the Ornish CIMT Study as “convincingly null, showing that pomegranate juice

treatment did not improve CIMT” and opined that the Ornish CIMT Study confirmed that the purportedly positive

results of Dr. Aviram's unrandomized, uncontrolled 19-patient CIMT/BP Study lacked credibility. F. 861, 862.

However, Dr. Sacks admitted that the lack of statistical significance for a positive result in the Ornish CIMT Study

is not proof of a negative. F. 867.

Dr. Ornish testified that the Ornish CIMT Study was an indeterminate study that cannot be relied upon; “it neither

proves or disproves.” F. 864. Dr. Ornish explained that the protocol for the Ornish CIMT Study called for 200

patients, but ultimately, only 73 patients were recruited, 56 of whom completed one-year testing. F. 851. Dr.

Ornish further stated: Even in this smaller group, we found improvements in right CIMT that approached statistical

significance and that if these changes had been seen in a sample of 200 patients, then it would have been statistically

significant. F. 857, 863. Dr. Heber observed that the Ornish CIMT Study “had inadequate power at that number

of subjects,” so no conclusions could be drawn from the study. F. 865.

(f) Determination

As discussed above, the expert testimony regarding the studies measuring CIMT to support Respondents' claims

is conflicting. The greater weight of the persuasive expert testimony on the studies sponsored by Respondents

measuring CIMT demonstrates that the scientific evidence relied upon by Respondents is not adequate to

substantiate a claim that the POM Products treat, prevent, or reduce the risk of heart disease through reducing

arterial plaque, or that clinical studies show the same.

vi. Clinical trials; improving blood flow

*217 In support of claims that the POM Products treat, prevent, or reduce the risk of heart disease by improving

blood flow (myocardial perfusion), in addition to the basic science discussed above, Respondents rely on the

Ornish MP Study. RRB at 106.

(a) About the Ornish MP Study

In the Ornish MP Study, Dr. Ornish and his colleagues investigated whether the daily consumption of pomegranate

juice for three months would affect myocardial perfusion (“MP”) in 45 patients who had coronary heart disease

and myocardial ischemia (narrowing of the arteries) in a randomized, placebo-controlled, double-blind study,

which was subsequently published. F. 805, 808. The Ornish MP Study indicated that after three months there was a

significant (p = 0.05) improvement of 17% in the summed differences score (“SDS”) 17 in the POM Juice group, as

compared to an average worsening of 18% in the control group. F. 811. Thus, after three months, the comparative

benefit in blood flow of the pomegranate juice group to the placebo group in the Ornish MP Study was about

35 percent. F. 811. The Ornish MP Study concluded: “Although the sample in this study was relatively small,

the strength of the design and the clinically significant and statistically significant improvements in myocardial

perfusion observed in the experimental group over a rather short period suggest that daily consumption of

pomegranate juice may have important clinical benefits in this population.” F. 815.
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(b) Expert opinions on the Ornish MP Study

Complaint Counsel criticizes the Ornish MP Study, inter alia, on the following grounds: (1) change in myocardial

perfusion is not a recognized surrogate marker of therapeutic effects on coronary heart disease; (2) the Ornish

MP Study indicates significant changes in only one of three measures of blood flow — in summed difference

score (SDS), but not summed rest score (SRS) or summed stress score (SSS); (3) the study was designed to last

12 months, but was cut short at 3 months; (4) the study showed no improvement in other measures, such as blood

pressure, cholesterol, inflammatory biomarkers, and oxidative stress; and (5) there were problems in the design

and conduct of the study. Respondents' replies to each of these challenges to the adequacy of the Ornish MP Study

to substantiate claims regarding improving blood flow are addressed, in order, below.

First, the Ornish MP Study measured improvements in myocardial perfusion. F. 808. Complaint Counsel's experts

opined that myocardial perfusion is a research tool, but is not recognized as a surrogate marker for heart disease

and is not used as the primary outcome in studies of treatment efficacy for coronary heart disease. F. 825. Dr.

Sacks further opined that even where blood flow is shown to have been improved, it will not necessarily result

in improved cardiovascular health, such as reductions in heart attack and stroke. F. 825. However, Dr. Sacks

conceded that proper blood flow from the coronary artery and to the heart is fundamental to lowering the risk of

cardiovascular disease. F. 826.

*218 Dr. Ornish, for Respondents, opined that blood flow is essential to life, an important measure of heart

disease, and the “bottom line” in coronary heart disease (along with how well the heart is pumping blood) and,

thus, when researchers measure myocardial perfusion, researchers are measuring what actually matters most. F.

827. As Dr. Ornish explained, blood carries oxygen and nutrients that feed the heart. F. 828. If the blood flow

to the heart (perfusion) is reduced, then the heart is no longer receiving enough blood flow to maintain itself. F.

828. Coronary heart disease, which is the most common form of heart disease, occurs when the heart does not get

enough blood to fuel itself and blood carries oxygen, which is the fuel for the heart. F. 828.

In addition, Respondents' experts opined that myocardial perfusion is more closely connected as a surrogate marker

for cardiovascular disease than LDL cholesterol, which has been accepted by the FDA as a surrogate marker. F.

829. Dr. Ornish explained that when a person has a biomarker such as high LDL cholesterol, which increases his

or her risk, that is far away from the actual event of a heart attack, which may be affected by many other factors,

such as inflammation and oxidation. F. 829. There are a number of people who have low cholesterol levels, but

get heart disease. F. 829. About 50 percent of the people who die from a heart attack actually have cholesterol

in the normal range. F. 829. There are people who have high cholesterol levels who do not have heart disease,

and the same is true for blood pressure. F. 829.

Second, the Ornish MP Study report indicates significant changes in only one of three measures of blood flow. F.

833. Complaint Counsel's experts testified that the .05 “p” value of the SDS improvement is not very persuasive

where, as in the Ornish MP Study, there were three possible outcome measures (SSS, SRS, and SDS), and only

one just met significance. F. 833.

Responding to these criticisms, Dr. Ornish explained that he did not ignore the SRS and SSS measures, but that

those were not the objective of the Ornish MP Study because they measure infarcted or dead heart tissue. F. 832,

834. SDS is derived by subtracting SRS from SSS and the finding of statistically significant changes in SDS

confirmed what the researchers were hoping to find -- an improvement in blood flow to the heart when compared

to rest and stress. F. 832, 834.
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Complaint Counsel's experts also opined that there was a large discrepancy between the pomegranate juice and the

control groups in the baseline values of SRS and SSS, the two components of the SDS. F. 835. The control group's

baseline values were worse than those of the pomegranate group, and, thus, it could be predicted that the control

group, having worse coronary perfusion than the pomegranate group at baseline, would have a more accelerated

form of the disease and show worsening on follow-up, according to Dr. Sacks. F. 836.

*219 Dr. Ornish explained that there was a difference in SSS at baseline, but no statistically significant

differences in SRS or SDS. F. 837. Dr. Ornish further testified that the Ornish MP Study employed an “analysis

of variance,” which took into account any baseline differences. F. 837.

Third, the Ornish MP study was originally designed to last 12 months, with measurements at baseline, 3 months,

and 12 months. F. 843. Complaint Counsel charges that the study was cut short when the three-month data came

in favorably and Dr. Ornish faced cost overruns. CCB at 39. Dr. Sacks opined that the shortened study period and

failure to report the planned duration are inconsistent with widely-accepted standards for conduct of clinical trials

and undermine any confidence in the findings. F. 843.

Dr. Ornish testified that the Ornish MP Study was terminated after three months only because the Resnicks did

not provide the funding that they had previously committed to this study, not because the p-value was statistically

significant at three months. F. 844. Dr. Ornish further opined that while he did not have 12 months of follow-up

data, this does not reduce the confidence in the three-month findings of the Ornish MP Study. F. 844.

Fourth, Complaint Counsel's expert criticized the Ornish MP Study on the additional basis that blood pressure,

cholesterol, inflammatory biomarkers, and oxidative stress were not improved. F. 838. Dr. Ornish himself

concluded that “blood pressure ... did not improve” in the Ornish MP Study. F. 839. However, Dr. Ornish

explained, the fact that other factors such as blood pressure and cholesterol did not improve does not in any

way provide evidence that pomegranate juice was not beneficial, as its effects may have been mediated via other

pathways. F. 840.

Fifth, Complaint Counsel's experts point out various other problems in the design and conduct of the study,

including providing data on only 39 of the 41 patients and unblinding of 6 patients mid-way through the Ornish

MP Study. F. 820, 824. In trial testimony and in his expert report, Dr. Ornish acknowledged that “some problems”

occurred during the Ornish MP Study that were not “optimal,” but opined that the difference in SDS remained

statistically significant and, therefore, the conclusions of the study remain valid. F. 819, 821.

Complaint Counsel's expert, Dr. Sacks, concluded, “the interpretation of [the Ornish MP] study that is most

consistent with the principles of clinical study design and conduct is that the treatment had no effect on any

measure of cardiac health” and that experts in the field of cardiovascular disease would not consider the Ornish

MP Study to support the proposition that pomegranate juice provides a heart disease benefit. F. 845.

Respondents' expert, Dr. Ornish, the author of the study, concluded that the Ornish MP Study constitutes credible

and reliable science showing that pomegranate juice lessens the risk of cardiovascular problems; that in people

who have already had heart disease, it improves blood flow and reverses the progression of heart disease; and if

you can begin to reverse a disease, it would only make sense that pomegranate juice would work even better to

help prevent heart disease in the first place. F. 847.

(c) Determination

*220 As discussed above, the expert testimony regarding the Ornish MP Study is conflicting. The greater weight

of the persuasive expert testimony on the Ornish MP Study demonstrates that the scientific evidence relied upon
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by Respondents is not adequate to substantiate a claim that the POM Products treat, prevent, or reduce the risk of

heart disease through improving blood flow, or that clinical studies show the same.

c. Conclusion

Having fully considered and weighed all the evidence and the conflicting expert testimony on Respondents'

basic science and clinical trials, the greater weight of the persuasive expert testimony demonstrates that there is

insufficient competent and reliable scientific evidence to substantiate a claim that the POM Products treat, prevent,

or reduce the risk of heart disease, by lowering blood pressure, reducing arterial plaque and/or increasing blood

flow to the heart, or are clinically proven to do so. F. 962. Accordingly, Complaint Counsel has met its burden of

proving that Respondents' substantiation was inadequate to make the implied heart disease claims found to have

been made in this case, and that, therefore, such claims were false or misleading.

4. Substantiation for Respondents' prostate cancer claims

a. Overview

As discussed in Section III.E.2.d, supra, the evidence demonstrates that Respondents disseminated advertisements

that impliedly represented that the POM Products are clinically proven to treat, prevent, or reduce the risk of

prostate cancer, by prolonging prostate-specific antigen (“PSA”) doubling time. Complaint Counsel contends that

(1) Respondents did not possess and rely upon a reasonable basis to substantiate their efficacy claims that the POM

Products treat, prevent, or reduce the risk of prostate cancer; and (2) clinical studies, research, and/or trials do

not prove Respondents' establishment claims that the POM Products treat, prevent, or reduce the risk of prostate

cancer. CCB at 44-50. With respect to claims made about prostate cancer, although Respondents have been found

to have made establishment claims only, by virtue of their very nature, the advertisements containing establishment

claims also make the efficacy claims that are challenged as unsubstantiated in the Complaint. CCB at 31.

i. Summary of expert opinions

In support of its position, Complaint Counsel submitted the expert report and testimony of Dr. James Eastham and

Dr. Stampfer. Dr. Eastham is Chief of Urology, Department of Surgery, and Director of Clinical Research, Urology

Department at Memorial Sloan Kettering Cancer Center. F. 200. He is a board-certified urological surgeon who has

treated more than 2,000 patients with prostate cancer and has extensive experience, including as an investigator,

in the design and conduct of clinical trials studying prostate cancer. F. 200, 201. Dr. Eastham is an expert in the

fields of urology, including the prevention and treatment of prostate cancer, as well as clinical testing related to

the prevention and treatment of prostate cancer. F. 204. Dr. Stampfer has participated in research investigating

risk factors (including food intake and dietary factors) associated with prostate cancer. F. 183. An expert in

nutrition, including its relation to the prevention and treatment of prostate cancer, and clinical testing related to

the prevention of prostate cancer, Dr. Stampfer also reviewed Respondents' prostate cancer research and provided

his independent opinion. F. 190.

*221 Dr. Eastham and Dr. Stampfer state that to support claims that the POM Products prevent prostate cancer,

or that they have been clinically proven to do so, experts in the field of prostate cancer would require at least

one well-designed, randomized, double-blind, placebo-controlled clinical trial involving an appropriate sample

population and endpoint. F. 626, 648. Dr. Eastham opined that the appropriate sample population for a cancer

prevention trial “would involve more than 10,000 healthy men, ages 50 to 65, having no sign of prostate cancer.”

F. 1092. Dr. Eastham also testified that “[a] prostate cancer prevention study must be conducted over a long

enough period of time to see an effect over time.” F. 1093. Dr. Eastham states that “[t]he primary endpoint in a
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prostate cancer prevention trial for measuring whether a product has been effective is the prevalence or incidence

of prostate cancer between the treatment and placebo groups at the conclusion of the study.” F. 1089.

Dr. Eastham and Dr. Stampfer also state that to support claims that the POM Products treat prostate cancer, or

that they have been clinically proven to do so, experts in the field of prostate cancer would require a randomized,

placebo-controlled, double-blind clinical trial with an appropriate sample population and endpoint. F. 626, 648.

Dr. Eastham and Dr. Stampfer further opine that PSA doubling time is not recognized by experts in the field as

a surrogate endpoint in prostate cancer clinical trials. F. 1100.

Complaint Counsel's experts concluded that evidence relied upon by Respondents does not constitute adequate

substantiation for claims that the POM Products treat, prevent, or reduce the risk of prostate cancer or have been

clinically proven to do so. F. 1019, 1086-1094, 1096-1099.

In support of their position that they possessed and relied upon a reasonable basis to substantiate their claims,

Respondents submitted the expert reports and testimony of Dr. David Heber and Dr. Jean deKernion. Dr. Heber is

a practicing physician, Professor of Medicine and Public Health at UCLA, and the Director of the UCLA Center

for Human Nutrition. F. 221, 222. Dr. Jean deKernion is the Chairman of the Department of Urology and Senior

Associate Dean for Clinical Affairs at the UCLA School of Medicine and served as the Dean of Urology at the

UCLA School of Medicine for twenty-six years. F. 251. Dr. deKernion is also a practicing urologist certified by

both the American Board of Surgery and the America Board of Urology. F. 250.

Dr. Heber reviewed Respondents' science in the area of prostate cancer and testified at trial that there is competent

and reliable science showing that POM Juice and POMx Pills lengthen the PSA doubling time for men who have

had prostate cancer and, thus, it is likely for those men to have a deferred recurrence or death from that disease;

and that POM Juice and POMx Pills are likely to lower the risk of prostate problems for men who have not yet

been diagnosed with prostate cancer. F. 1120. Dr. Heber's expert report, however, was more limited than his trial

testimony, opining: the statistically significant prolongation of PSA doubling time, coupled with corresponding

laboratory effects on prostate cancer in vitro cell proliferation and apoptosis [programmed cell death], as well as

oxidative stress and inflammation, provides strong scientific rationale for the statement that pomegranate juice

promotes prostate “health.” F. 1121.

*222 Dr. deKernion testified that the POM Products are beneficial to prostate health. F. 1124. Dr. deKernion

opined that although there is not 100% proof that the POM Products reduce the risk of prostate cancer, the

same mechanism shown in the in vitro and animal studies and in the Pantuck and Carducci human studies

(discussed below) showed, with a “high degree of probability,” that POM Juice and POMx would inhibit the

clinical development of prostate cancer in men who have not been diagnosed with that disease. F. 1124. Dr.

deKernion testified also that there is a high probability that the POM Products provide a special benefit to men

with detectable PSA after radical prostatectomy. F. 1125.

ii. Standard for substantiation

Having fully considered and weighed the evidence adduced at trial, the evidence demonstrates that competent and

reliable scientific evidence is required to support claims that the POM Products treat, prevent, or reduce the risk of

prostate cancer, or that they have been clinically proven to do so. See F. 963-966. Based on the greater weight of

the persuasive evidence from the experts at trial, to support claims that the POM Products treat, prevent, or reduce

the risk of prostate cancer, or that they are clinically proven to do so, competent and reliable evidence must include

clinical studies, although not necessarily RCTs, that show that the POM Products did treat, prevent, or reduce

the risk of prostate cancer. See id. As analyzed below, Complaint Counsel has demonstrated that Respondents

did not possess adequate competent and reliable scientific evidence to substantiate the implied claims that the
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POM Products treat, prevent, or reduce the risk of prostate cancer or that clinical tests show the same. Complaint

Counsel has, therefore, met its burden of proving that Respondents' claims are false or misleading. See QT, 448

F. Supp. 2d at 959.

b. Scientific evidence relied upon

i. In vitro and in vivo studies

The mechanism by which pomegranates promote prostate health is through potent antioxidant and

antiatherosclerotic properties 18 attributed to pomegranates' high content of polyphenols, including ellagic acid

and tannins. F. 725. Ellagic acid and tannins have been shown to exhibit in vitro and in vivo anticarcinogenic

properties, such as induction of cell cycle arrest and apoptosis, as well as the inhibition of tumor formation and

growth in animals. F. 990. In vivo research has demonstrated that pomegranate polyphenols reduce inflammation in

prostate tumors. F. 995. In vitro and in vivo research has also demonstrated that in tumors treated with pomegranate

extract, the nuclear factor-kappaB decreased (see below), thereby causing decrease of tumor growth. F. 1007.

Working from these foundations, Respondents sponsored several in vitro and animal studies to examine the effect

of POM Juice and POMx Pills on prostate health. F. 1010. Detailed findings of fact on these studies are set forth

in Section II.H.3, supra. In summary, in this pre-clinical research, which studied human prostate cancer cells in

the lab and inside of mouse models, POM Juice was found to inhibit cancer cell growth, promote prostate cell

death, and inhibit the inflammatory process, which is correlated with the growth of cancer. See id.

*223 For example, in a study titled, “Pomegranate Ellagitannin-Derived Metabolites Inhibit Prostate Cancer

Growth and Localize to the Mouse Prostate Gland,” Dr. David Heber and colleagues evaluated the effects of

pomegranate extract on prostate cancer growth in severe combined immunodeficient mice injected with human

prostate cancer cells. F. 1014. The study showed that pomegranate extract significantly inhibited prostate cancer in

the mice, as compared to the control. F. 1014. Researchers also found that ellagic acid and synthesized urolithins

from the pomegranate extract were shown to inhibit the growth of human prostate cancer cells in vitro. F. 1014.

The researchers concluded that the chemopreventive potential of pomegranate ellagitannins and localization of

their bioactive metabolites in mouse prostate tissue suggest that the pomegranate may play a role in prostate cancer

treatment and chemoprevention. F. 1014 (emphasis added). The researchers also stated that “[t]his warrants future

human tissue bioavailability studies and further clinical studies in men with CaP [prostate cancer].” F. 1014.

Another study by Dr. Rettig and Dr. Heber, et al., titled, “Pomegranate extract inhibits androgen-independent

prostate cancer growth through a nuclear factor-kappaB-dependent mechanism,” evaluated POMx Pills and POM

Juice and found that their consumption was linked to reduction in cancer growth and decreased plasma PSA

levels. F. 1016. The study found that one of the most well-established signaling pathways mediating inflammatory

responses relevant to cancer is the nuclear factor-KappaB (“NF-kB”) pathway, which serves as a predictor for

recurrence of prostate cancer after radical prostatectomy, and that POMx inhibited NF-kB and cancer cell viability

in a dose response fashion in vitro and in a human LAPC4 prostate cancer xenograft mouse model. F. 1016.

Based on the results, the researchers concluded “that pomegranate juice could have potential as a dietary agent

to prevent the emergence of androgen-independence,” thus, potentially prolonging life expectancy of prostate

cancer patients, and suggested “that this may be a high priority area for future clinical investigation.” F. 1016

(emphasis added).

As testified to by Dr. deKernion, Respondents' in vitro and animal studies showed that pomegranate juice inhibited

the growth of prostate cancer cells and actually killed cancer cells from humans that had been inserted into mice.

F. 1020. However, as Dr. deKernion also testified, and Complaint Counsel's experts concurred, one cannot always

extrapolate from in vitro and animal results to what the results would be in humans. F. 1022. Experts in the field
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agree that even where the animal and in vitro evidence is strong and shows that an agent's mechanism of action

works, this evidence alone does not prove that an agent works in humans and, thus, does not show that the POM

products treat, prevent, or reduce the risk of prostate cancer. F. 1024.

ii. Clinical trials

*224 Respondents have sponsored one human clinical study, which is completed and published, and one human

clinical study that is not yet published. F. 1025. The published study, titled, Phase II Study of Pomegranate Juice

for Men with Rising Prostate-Specific Antigen Following Surgery or Radiation for Prostate Cancer by Pantuck,

et. al, was published in the journal Clinical Cancer Research in 2006. (“Pantuck Study”). F. 1030. The ongoing

human clinical study, by Dr. Michael A. Carducci, is completed, and an abstract summarizing the results has

been published, but a final, peer-reviewed study report had not been published at the start of trial in this matter.

The abstract is titled, A Phase II Study of Pomegranate Extract for Men with Rising Prostate-Specific Antigen

Following Primary Therapy, J Clin Oncol 29: 2011 (suppl 7; abstr 11) (“Carducci Study”). Detailed findings of

fact on the Pantuck Study and the Carducci Study are set forth in Section II.H.4, supra, and summarized here.

(a) The Pantuck Study

The Pantuck Study was conducted by Dr. Allan Pantuck, an Associate Professor of Urology at UCLA Medical

School who maintains a clinical practice at UCLA. F. 1026. Dr. Pantuck's study was the first clinical trial of

pomegranate juice in patients with prostate cancer. F. 1036. According to the published study report, the Pantuck

Study was “an open-label, single-arm [one treatment group] clinical trial,” meaning it was not an RCT and did

not have a placebo group. F. 1037. The Pantuck Study included 46 patients who had been diagnosed with prostate

cancer. F. 1039. All 46 patients in the Pantuck Study drank eight ounces of pomegranate juice daily and had their

blood drawn every three months to have their PSA determined. F. 1043. The presence of detectable PSA after

radical prostatectomy or other radical treatment usually indicates cancer is present. F. 1041. PSA doubling time

(“PSADT”) is a mathematical expression of the rapidity with which the prostate specific antigen is rising, and an

expression of the rapidity of growth and number of prostate tumor cells. F. 1042.

Patients in the Pantuck Study who consumed POM Juice experienced a statistically significant increase in PSADT,

when compared to their own baseline pre-treatment PSADT. F. 1044. In the Pantuck Study, the average pretreatment PSADT before intervention was approximately 15 months, and after 33 months, the average posttreatment PSADT was approximately 54 months. F. 1054. Thus, mean PSADT significantly increased from a mean

of 15 months at baseline to 54 months post-treatment. F. 1045. The Pantuck Study concluded that the statistically

significant prolongation of PSA doubling time, coupled with corresponding laboratory effects on prostate cancer

in vitro cell proliferation and apoptosis, as well as oxidative stress, warrant further testing in a placebo-controlled

study. F. 1047.

In 2008, Dr. Pantuck presented a follow-up report and released the abstract titled, Pantuck, AJ, et al., “Long

term follow up of pomegranate juice for men with prostate cancer and rising PSA shows durable improvement

in PSA doubling times,” American Society of Clinical Oncology (“Pantuck Phase II Follow-Up Results”), which

summarized follow-up results for the Pantuck Study. F. 1048. According to the published abstract, fifteen active

patients (31%) remained on the study. F. 1049. All of the men who had dropped out of the Pantuck Study did

so because their PSA had increased. F. 1049. The Pantuck Phase II Follow-Up Results stated that those who

continued on pomegranate juice maintained a lengthening of their PSA doubling time compared to men who did

not continue on pomegranate juice. F. 1050. The Pantuck Phase II Follow-Up Results found that long-term follow

up of pomegranate juice consumption in men with prostate cancer and rising PSA following primary therapy

demonstrates a durable increase in PSA doubling time and concluded that a multi-center, randomized phase III

study is ongoing to further evaluate the benefits of pomegranate in a placebo-controlled manner. F. 1052.
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*225 When the Pantuck Study report was released in 2006, Dr. Pantuck was quoted in an American Association

for Cancer Research press release, as stating: “[w]e don't believe we are curing anyone from prostate cancer.” F.

1054. He pointed out that “although a third of patients experienced a decrease in PSA during the study, nobody's

PSA went to zero.” F. 1054. Dr. Pantuck further explained: “The PSA doubling time, however, was longer. For

many men, this may extend the years after surgery or radiation that they remain recurrence free and their life

expectancy is extended.” F. 1054.

(b) The Carducci Study

The Carducci Study was conducted by Dr. Michael Carducci, a Professor of Oncology and Urology at the Johns

Hopkins University School of Medicine, in Baltimore, Maryland. F. 1065. Dr. Carducci has conducted 40 to 50

clinical trials relating to prostate cancer and has published approximately 80 articles related to prostate cancer.

F. 1067.

In 2006, Dr. Carducci began working with Respondents to design the Carducci Study. F. 1068. Dr. Carducci

submitted a proposed protocol for the Carducci Study to Respondents for a larger randomized three-arm (three

groups) study, with two treatment arms and one placebo arm. F. 1068. Respondents conducted a cost and feasibility

analysis and decided that the study proposed by Dr. Carducci was too costly, and, thus, the placebo arm was

dropped from the study. F. 1069. The Carducci Study began in January 2008. F. 1070. In 2011, Dr. Carducci

presented the abstract of his clinical research study titled, “A Phase II Study of Pomegranate Extract for Men with

Rising Prostate-specific Antigen Following Primary Therapy” at the disease specific meeting of the American

Society of Clinical Oncology (“Carducci abstract”). F. 1072.

The Carducci Study was a multi-center, double blind Phase II randomized trial that studied the effect of two

different doses of POMx Pills (one or three capsules) on PSADT in men who had received initial therapy for

prostate cancer. F. 1070. One hundred and four (104) men were enrolled and treated for up to six months (92%),

12 months (70%), and 18 months (36%). F. 1075. PSA levels were obtained every three months. F. 1074.

The Carducci abstract stated: median PSADT lengthened from 11.9 months at baseline to 18.5 months after

treatment, a within group measurement, which showed that POMx treatment significantly increased the PSA

doubling time by over six months in both treatment arms. F. 1076. There was no significant treatment difference

in PSADT between the group who took one capsule and the group who took three capsules of POMx. F. 1075.

The Carducci abstract also stated that 13 patients (13%) had declining PSA levels during the study. F. 1077. The

Carducci abstract concluded that POMx demonstrates “promising antitumor effects in prostate cancer.” F. 1078.

(c) Expert Opinions of the Pantuck and Carducci Studies

Complaint Counsel's experts, Dr. Eastham and Dr. Stampfer, opined that the Pantuck Study and Carducci Study

do not constitute adequate substantiation for Respondents' claims that the POM Products treat, prevent or reduce

the risk of prostate cancer, for a number of reasons, including: (1) the studies lacked a placebo-control group;

(2) PSA doubling time is not a valid endpoint; (3) the studies do not assess whether the POM Products prevent

prostate cancer; and (4) the results of the Pantuck Study on POM Juice cannot be used to support claims made

about POMx Pills. Respondents' replies to each of these challenges to the adequacy of Respondents' substantiation

are addressed, in order, below.

*226 First, the Pantuck Study and Carducci Study did not have a placebo-control group. F. 1037, 1069, 1070.

Complaint Counsel's experts opined that without a control group, it is not possible to conclude that the POM

Products alone had an effect on the patients' PSA. F. 1087, 1088, 1096. Respondents' expert, Dr. deKernion
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testified that in both the Pantuck Study and the Carducci Study, the control was the previous PSA doubling time

prior to treatment. F. 1115. The researchers measured the doubling time before patients took POM Juice or POMx

and then measured doubling time afterwards, comparing one to the other. F. 1115. Dr. deKernion further testified

that a control arm is often used to control for the placebo effect and that the use of a placebo group is more

important when you have a subjective reporting (such as level of pain), as opposed to an objective reporting

(such as PSADT). F. 1116, 1117. However, Dr. deKernion also acknowledged that without a placebo, one cannot

be certain that the effect on PSA doubling time seen in the Carducci Study is attributable to POMx. F. 1118.

Furthermore, Dr. Pantuck testified that the lack of a “blinded control” group was the “greatest limitation” of his

study, and Dr. Carducci testified that without a placebo, he cannot be sure that the effect on PSADT observed in

the Carducci Study is attributable to POMx. 19 F. 1060, 1083.

Second, the Pantuck Study and the Carducci Study used mean PSA doubling time as the primary endpoint. F.

1040, 1070. The expert testimony on the validity of PSA doubling time as a primary endpoint is conflicting.

Complaint Counsel's experts, Dr. Stampfer and Dr. Eastham, both criticized this method, opining that it is unknown

if PSADT predicts overall survival in prostate cancer patients throughout its range, PSADT is not a surrogate for

overall survival, and PSADT is not a relevant surrogate marker for prostate cancer prevention. F. 1089, 1097.

However, Dr. Stampfer also testified that PSA doubling time is a “predictor of disease and mortality” and that,

if the extension of PSA doubling time is true, it would substantially prolong lives. F. 1104. Dr. Eastham, too,

offered a contradictory opinion to his opinion at trial in an article wherein he concluded, “PSADT is an important

prognostic marker in men with biochemical failure after local therapy for prostate cancer, and it predicts the

probable response to salvage radiotherapy, progression to metastatic disease and prostate cancer specific death.”

F. 1102.

Respondents' expert, Dr. Heber, testified that PSA doubling time is a “very important clinically utilized marker

of clinical status.” F. 1112. See also F. 1113 (Dr. Heber testifying that there is a lot of support from the urological

community to get the FDA to accept PSA doubling time as a surrogate endpoint). Dr. deKernion testified that

given the understanding of PSA doubling time in predicting risk of clinical recurrence and to some extent survival,

it is logical to use changes in PSADT as indicative of an intervention's effectiveness regarding prostate tumor

behavior. F. 1110. Dr. deKernion also acknowledged, however, that PSA doubling time is not accepted by experts

in the field of prostate cancer as a surrogate endpoint for clinical benefit in chemotherapy trials. F. 1111.

*227 As testified to by Dr. Pantuck, “[i]t remains controversial whether modulation of PSA levels represents

an equally valid clinical end point.” F. 1059. On the one hand, Dr. Pantuck testified that “PSA has not been

validated prospectively as a surrogate endpoint for a meaningful prostate cancer outcome.” F. 1059. On the other

hand, Dr. Pantuck stated that “although PSA changes are thought to be prognostically important, it is based on

level 2 evidence, and nobody has ever shown conclusively that changes in PSA kinetics arising from therapeutic

intervention is meaningful.” F. 1059. Dr. Carducci's testimony on this point also underscores this conflict. While

Dr. Carducci testified that the use of PSA doubling time as a primary endpoint to determine if POMx has an effect

on the disease state was a scientifically valid way to conduct the Carducci Study, he also acknowledged that PSA

doubling time as a marker or surrogate has not been proven and that the endpoint of PSA doubling time is not a

standard for regulatory approval of drugs at the FDA level. F. 1079, 1080.

There are no studies proving that changing the rate of PSA doubling time changes the natural history of prostate

cancer by delaying the development of metastases or death from the disease. F. 1131. Experts in the field of prostate

cancer agree that PSADT is not an accepted surrogate endpoint for survival or prostate cancer-specific mortality

in prostate cancer treatment clinical trials. F. 1134. Although this Initial Decision does not require Respondents to

meet FDA standards for clinical trials to substantiate claims about a food or food-derived product that is safe and

not being sold as an alternative to medical treatment, because the use of PSA doubling time as a valid endpoint is

controversial, this factors into evaluating the adequacy of Respondents' substantiation.
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Third, Complaint Counsel's experts point out that the clinical studies examining the effect of the POM Products

on prostate cancer have been conducted on men who either have prostate cancer, or have been treated for prostate

cancer and have experienced a biochemical recurrence. F. 1039, 1070. Because the Pantuck Study and Carducci

Study were designed as treatment studies, Dr. Eastham and Dr. Stampfer opine that there is no competent and

reliable scientific evidence supporting a claim that the POM Products prevent prostate cancer. F. 1091, 1099.

Respondents' expert, Dr. deKernion, explained that in order to show an effect of POM Products on prostate cancer,

the best way to do that research is on patients whose prostate had been removed, because the presence of PSA

elevation is almost always an indication of remaining cancer. F. 1122. Dr. deKernion further opined that although

there is not proof that POM Products reduce the risk of prostate cancer, the same mechanism shown in the in vitro

and animal studies and in the Pantuck and Carducci human studies showed, with a “high degree of probability,”

that POM Juice and POMx would inhibit the clinical development of prostate cancer in men who have not been

diagnosed with that disease and that POM Juice and POMx could possibly play a role in preventing them from

getting prostate cancer. F. 1124; see also F. 1123.

*228 Dr. Pantuck acknowledged that the Pantuck Study did not prove that pomegranate juice prevents or reduces

the risk of prostate cancer because all the patients in the study already had prostate cancer and, thus, his study did

not address anything related to causation. F. 1055. Dr. Carducci similarly testified that the Carducci Study was

never designed to prove, and did not prove, that POMx prevents or reduces the risk of prostate cancer. F. 1084.

Fourth, Complaint Counsel's experts state that the Pantuck Study on POM Juice cannot provide reliable evidence

to support claims about POMx Pills' benefit for prostate cancer. F. 1094. According to Dr. Eastham: POM Juice

is not identical to POMx Pills and POMx Liquid; POM Juice has more than one active ingredient; processing may

result in eliminating a needed ingredient; and even if the active ingredient is known and the alternate compound

contains the same amount of active ingredient, the alternate compound may contain some other as yet unknown

compound that might counter-act the benefit of the active agent. F. 1094. However, Dr. Eastham is not an expert

in bioavailability and did not review the equivalency studies or articles on POM Juice, POMx Pills or POMx

Liquid. F. 1095.

Dr. Heber, the only expert who opined on the bioavailability of pomegranate polyphenols, explained that because

both the 100% Juice and POMx contain ellagitannins that contribute to the antioxidant activity of the products

(and because both are bioavailable (absorbed) in humans), there is no difference in the antioxidant effect between

POM Juice and POMx products in laboratory studies. F. 953, 1119. Dr. Heber testified that in laboratory studies

he conducted, he found no difference in the antioxidant effect between POM Juice and POMx products and that

animal studies indicate that the effects of pomegranate juice and POMx Pills on prostate cancer are equivalent. F.

1119. Moreover, the Carducci Study obtained a result similar to the Pantuck Study regarding the effect of POMx

on PSADT. Compare F. 1076 with F. 1045.

c. Conclusion

As discussed above, the expert testimony regarding the studies relied upon by Respondents is conflicting.

The greater weight of the persuasive expert testimony demonstrates the following: The basic research, the

Pantuck Study, and the Carducci Study, relied on by Respondents, support the conclusion that pomegranate

juice has a beneficial effect on prostate health. F. 1142. Competent and reliable scientific evidence supports

the conclusion that the consumption of pomegranate juice and pomegranate extract supports prostate health,

including by prolonging PSA doubling time in men with rising PSA after primary treatment for prostate cancer.

F. 1142. However, the greater weight of the persuasive expert testimony shows that the evidence relied upon by

Respondents is not adequate to substantiate claims that the POM Products treat, prevent, or reduce the risk of
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prostate cancer or that they are clinically proven to do so. F. 1143. Indeed, the authors of the Pantuck Study and

the Carducci Study each testified that their study did not conclude that POM Juice treats, prevents, or reduces

the risk of prostate cancer. F. 1055, 1056, 1084, 1085. And, as Respondents' expert conceded, no clinical studies,

research and/or trials show definitively that the POM Products treat, prevent, or reduce the risk of prostate cancer.

F. 1135-1138.

*229 Having fully considered and weighed all the evidence and the conflicting expert testimony on Respondents'

basic research and clinical trials, the greater weight of the persuasive expert testimony demonstrates that there is

insufficient competent and reliable scientific evidence to substantiate a claim that the POM Products treat, prevent,

or reduce the risk of prostate cancer or that clinical studies, research, and/or trials prove that the POM Products

treat, prevent, or reduce the risk of prostate cancer. F. 1143. Accordingly, Complaint Counsel has met its burden

of proving that Respondents' substantiation was inadequate to make the implied prostate cancer claims found to

have been made in this case, and that, therefore, such claims were false or misleading.

5. Substantiation for Respondents' erectile dysfunction claims

a. Overview

As discussed in Section III.E.2.e, supra, the evidence demonstrates that Respondents disseminated advertisements

that impliedly represented that drinking eight ounces of POM Juice daily, or taking one POMx Pill daily, is

clinically proven to treat, prevent or reduce the risk of erectile dysfunction. Complaint Counsel contends that (1)

Respondents did not possess and rely upon a reasonable basis to substantiate their efficacy claims that the POM

Products treat, prevent, or reduce the risk of erectile dysfunction; and (2) clinical studies, research, and/or trials do

not prove Respondents' establishment claims that the POM Products treat, prevent, or reduce the risk of erectile

dysfunction. CCB at 50-54. With respect to claims made about erectile dysfunction, although Respondents have

been found to have made establishment claims only, by virtue of their very nature, the advertisements containing

establishment claims also make the efficacy claims that are challenged as unsubstantiated in the Complaint. CCB

at 31.

i. Summary of expert opinions

In support of its position, Complaint Counsel submitted the expert report and testimony of Dr. Arnold Melman,

M.D., a Professor and Chairman of the Department of Urology at the Albert Einstein College/Montefiore Medical

Center in New York. F. 208. Dr. Melman has extensive experience in designing and reviewing protocols for

clinical trials. F. 209. Dr. Melman is an expert in the evaluation of whether a product treats, prevents, or reduces

the risk of erectile dysfunction, and in the design and conduct of clinical trials involving erectile dysfunction. F.

211. Dr. Melman opined that to constitute a reasonable basis for the claims that the POM Products treat, prevent, or

reduce the risk of erectile dysfunction, or have been clinically proven to do so, at least one well-designed, human

RCT involving several investigatory sites is required. F. 654. Dr. Melman also opined that a well-designed, human

RCT must use a validated tool for measuring treatment outcomes and that the clinical trial must have a total sample

population large enough to produce clinically significant results and a statistical significance of p < 0.05. F. 655.

*230 Dr. Melman's opinions are attenuated for several reasons. Although Dr. Melman testified that the Global

Assessment Questionnaire (“GAQ”) is not a validated measure for assessing erectile function, Dr. Melman had

not heard of the term “GAQ” prior to forming his opinions in this case. F. 1196, 1233, 1234. Also, although Dr.

Melman testified that Respondents are required to conduct RCTs before making erectile dysfunction claims about

the POM Products, Dr. Melman has made claims about a gene transfer therapy for erectile dysfunction called

“hMaxi-K,” which he patented and hoped to market, based on an animal study and one study of 11 men. F. 659,
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660, 1237. In addition, Dr. Melman testified that a study to support a treatment for erectile dysfunction must show

that a man can complete intercourse to orgasm. F. 659.

In support of their position that they possessed and relied upon a reasonable basis to substantiate their claims,

Respondents submitted the expert reports and testimony of Dr. Arthur Burnett and Dr. Irwin Goldstein. Dr. Burnett

is an expert in the area of erectile health, a Professor of Urology at the Johns Hopkins University School of

Medicine/Johns Hopkins Hospital, and is well-known for his groundbreaking work on nitric oxide. F. 234, 238,

239. Dr. Burnett has treated between 10,000 and 15,000 patients for erectile dysfunction. F. 237. Dr. Burnett

opined that Respondents' basic scientific and clinical evidence supports the conclusion that pomegranate juice's

high antioxidant content improves erectile health and function by increasing the level and preservation of nitric

oxide. F. 242. Dr. Burnett also concluded that a safe pure fruit juice, like pomegranate juice, which is not used as a

substitute for proper medical treatment, does not require RCTs to substantiate erectile health claims. F. 683, 684.

Dr. Irwin Goldstein is an expert in sexual medicine who opined on the impact of pomegranate juice, antioxidants,

and nitric oxide on erectile function and dysfunction. F. 243, 247. Dr. Goldstein is a board certified urologist

and sexual medicine physician who has been involved in sexual medicine clinical practice, clinical research, and

basic research since 1980. F. 243, 244. Dr. Goldstein testified that competent and reliable scientific evidence fully

supports the conclusion that pomegranate juice produces a benefit to proper and effective erectile function. F.

249. Dr. Goldstein opined that RCT studies are not required to substantiate claims that pomegranate juice can aid

in erectile health and that in vitro and animal studies demonstrated a likelihood that pomegranate juice improves

erectile health. F. 686. Dr. Goldstein also opined that the consumption of pomegranate juice is a logical option

for men who are not responsive to conventional drugs or who are unwilling to consider invasive or mechanical

therapies for treatment of their erectile dysfunction. F. 1307, 1308.

ii. Standard for substantiation

Having fully considered and weighed the evidence adduced at trial, the evidence demonstrates that competent

and reliable scientific evidence is required to support claims that the POM Products treat, prevent, or reduce the

risk of erectile dysfunction or that they have been clinically proven to do so. See F. 1144-1148. Based on the

greater weight of the persuasive evidence from the experts at trial, to support claims that the POM Products treat,

prevent, or reduce the risk of erectile dysfunction, competent and reliable evidence must include clinical studies,

although not necessarily RCTs, that show that the POM Products did treat, prevent, or reduce the risk of erectile

dysfunction. See id. As analyzed below, Complaint Counsel has demonstrated that Respondents did not possess

adequate competent and reliable scientific evidence to substantiate the implied claims that the POM Products

treat, prevent, or reduce the risk of erectile dysfunction or that clinical tests show the same. Complaint Counsel

has, therefore, met its burden of proving that Respondents' claims are false or misleading. See QT, 448 F. Supp.

2d at 959.

b. Scientific evidence relied upon

*231 The mechanism by which pomegranates promote erectile health and function is through potent antioxidant

components and the impact on nitric oxide, which is of “paramount importance” to good erectile health and

function and is the key molecule that governs penile erections. See F. 1165-1184. Detailed findings of fact on

Respondents' six in vitro and in vivo studies and one human clinical study are set forth in Section II.I.3, supra.

Respondents' studies demonstrate the potential benefits of pomegranate juice on erectile health and function. F.

1310, 1312. These studies do not, however, show that the POM Products treat, prevent, or reduce the risk of

erectile dysfunction or show that clinical tests demonstrate that the POM Products treat, prevent, or reduce the

risk of erectile dysfunction. F. 1313, 1314.
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i. In vitro and in vivo studies

Dr. Louis Ignarro is highly respected and won a Nobel prize for his discoveries concerning nitric oxide (“NO”).

F. 1292, 1297. He conducted an in vitro study to evaluate pomegranate juice's capacity to protect NO against

oxidative destruction. F. 1292. Based on his findings, Dr. Ignarro concluded that pomegranate juice possesses

potent antioxidant activity that results in marked protection of NO against oxidative destruction, thereby resulting

in augmentation of the biological actions of NO. F. 1293, 1294. Other studies show similar results. See Section

II.I.3, supra. For example, using an animal model, Dr. Kazem Azadzoi and colleagues found that, due to high

antioxidant capacity, long-term pomegranate juice intake increased intracavernosal blood flow in the penis,

improved erectile responses, improved smooth muscle relaxation, and decreased erectile tissue fibrosis. F.

1275-1279. In addition to these in vitro and in vivo studies, multiple other significant scientific studies exist that

not only demonstrate the antioxidative powers of pomegranates in enhancing and preserving NO, but also support

the general proposition that antioxidants positively influence erectile health. See Section II.I.3, supra.

Complaint Counsel's expert, Dr. Melman, opined that basic research studies about antioxidants' effects on NO

levels may relate to the biochemical process for erectile function, but that basic research studies do not directly

involve erectile function in humans and cannot alone prove that POM Juice treats, prevents, or reduces the risk of

erectile dysfunction in humans. F. 1301. Respondents' experts reviewed the basic science relied upon Respondents

and concluded: basic science alone supports the potential benefit at the human level to improve the physiology

of erectile tissue preserving erect tissue health and, thus, suggests a probable benefit of pomegranate juice on

erectile health. F. 1298-1300.

ii. Clinical trial

Respondents also sponsored a clinical study, performed by Dr. H. Padma-Nathan, and published in the

International Journal of Impotence Research in 2007 (“Forest/Padma-Nathan Study). F. 1206. The Forest/PadmaNathan Study was an RCT of pomegranate juice versus placebo in men with erectile dysfunction. F. 1210.

The Forest/Padma-Nathan Study engaged 53 completed subjects with mild-to-moderate erectile dysfunction who

underwent two four-week treatment periods separated by a two-week “washout.” 20 F. 1211.

*232 Using a global assessment questionnaire (“GAQ”), Dr. Padma-Nathan found that participants rated

pomegranate juice 50% more effective than a placebo at improving erections. F. 1212, 1224. The GAQ results

achieved a probability value (“p-value”) of 0.058, meaning that the positive results of the study were 94.2% likely

to be the result of something other than “chance.” F. 1225. Although the p-value was a few thousandths of a

percentage point short of achieving statistical significance of 95%, the study has clinical significance in showing

a benefit from pomegranate juice on erectile tissue physiology and health. F. 1248, 1250.

Dr. Melman, Complaint Counsel's expert, criticized the Forest/Padma Nathan Study on grounds that the GAQ is

not a validated measure and does not provide clinically significant information; the study was not conducted over

a sufficient duration to show a sustained clinically significant effect on erectile function; and the study results

did not achieve statistical significance. F. 1233, 1235-1236. Respondents' experts reviewed the clinical evidence

that Respondents relied upon and concluded that even though statistical significance was not reached, the Forest/

Padma-Nathan Study “provides very valuable information” regarding erectile health and function and is “clinically

significant” because “it supports the conclusion that the positive results in the basic science are borne out in human

function.” F. 1238, 1239, 1245. See also F. 1240-1245.

c. Conclusion
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The greater weight of the persuasive expert testimony demonstrates the following: The basic research relied

upon by Respondents and the Forest/Padma-Nathan Study support the conclusion that pomegranate juice has a

beneficial effect on erectile tissue physiology, health, and function. F. 1310, 1312. The evidence relied upon by

Respondents also supports the conclusion that pomegranate juice is a potential treatment for erectile dysfunction.

F. 1147, 1243, 1252. The evidence relied upon by Respondents is not, however, adequate to substantiate a claim

that clinical studies show that the POM Products treat, prevent, or reduce the risk of erectile dysfunction or that

clinical studies show the same. F. 1253, 1313, 1314. Indeed, the authors of the Forest/Padma-Nathan Study each

testified that the study did not conclude that POM Juice treats, prevents, or reduces the risk of erectile dysfunction.

F. 1230.

Respondents' defense on this issue is that they did not make any claims that the POM Products treat, prevent, or

reduce the risk of erectile dysfunction. As such, Respondents' experts did not provide expert opinion on whether

Respondents' science was adequate to support a claim that the POM Products treat, prevent, or reduce the risk of

erectile dysfunction. Rather, the expert report of Dr. Goldstein states: “The available body of scientific literature

— including in vitro, in vivo, and preliminary clinical trials — strongly suggests that consuming pomegranate

juice promotes erectile health.” F. 249. The expert report of Dr. Burnstein concludes that the basic scientific and

clinical evidence is sufficient to support the use of pomegranate juice as a potential benefit for vascular blood flow

and the vascular health of the penis. F. 242, 1184. Thus, Respondents have failed to provide expert opinion on the

central issue of whether Respondents' science was adequate to support an implied claim that the POM Products

treat, prevent, or reduce the risk of erectile dysfunction, or that they are clinically proven to do so. See Daniel

Chapter One, 2009 FTC LEXIS 157, at *243 (Initial Decision).

*233 Based on the more persuasive expert testimony at trial, competent and reliable scientific evidence

demonstrates that pomegranate juice in its various forms provides a positive benefit to erectile health and erectile

function. F. 1312. However, as testified to by Respondents' expert, the use of pomegranate juice to promote erectile

health is a separate and distinct concept from the use of this neutraceutical as a safe and effective treatment for

the medical condition of erectile dysfunction such as with a PDE5 inhibitor. F. 249, 1311 (emphasis in original).

Having fully considered and weighed all the evidence and the conflicting expert testimony on Respondents'

basic science and clinical trial, the greater weight of the persuasive expert testimony demonstrates that there is

insufficient competent and reliable scientific evidence to substantiate claims that the POM Products treat, prevent,

or reduce the risk of erectile dysfunction or that they are clinically proven to do so. F. 1313, 1314. Accordingly,

Complaint Counsel has met its burden of proving that Respondents' substantiation was inadequate to make the

implied erectile dysfunction claims found to have been made in this case, and that, therefore, such claims were

false or misleading.

6. Summary

To summarize, in finding that Respondents' substantiation was not adequate, the facts that the POM Products

are derived from a fruit, are safe, and are not advocated as an alternative to medicine were all considered. In

addition, the cost and feasibility of conducting RCTs and the benefits of truthful claims were also considered.

Ultimately, however, the determination as to what “amount of substantiation experts in the field would agree is

reasonable” and “the level of proof sufficient to satisfy the relevant scientific community of the claim's truth”

must, in accordance with applicable law, turn on the nature of the claims made by Respondents.

In this case, as found in Section III.E.2., supra, Respondents disseminated advertisements that impliedly

represented that the POM Products treat, prevent, or reduce the risk of heart disease, prostate cancer, and/or erectile

dysfunction, and/or that “clinical studies, research, and/or trials prove” that the POM Products treat, prevent, or

reduce the risk of the same. As to these advertisements, whether or not Respondents' substantiation was adequate
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to support general and highly qualified health claims is not the material issue. Having crossed the line from making

general and highly qualified health claims to making implied disease claims, “the level of proof sufficient to

satisfy the relevant scientific community of the claim's truth” and “the amount of substantiation experts in the

field would agree is reasonable” were necessarily heightened. QT, 448 F. Supp. 2d at 962 (where defendants

make a “medical, health-related claim,” ... such a claim must be based on a heightened level of substantiation”).

With respect to both the establishment and efficacy claims that Respondents have been found to have made,

Respondents' substantiation failed to meet the level of substantiation required. Because Complaint Counsel met its

burden of proving that Respondents' substantiation was inadequate, the advertisements compiled in the Appendix

to this Initial Decision are false and misleading.

G. Whether Respondents' Claims are Material

1. Overview

*234 Having found that Respondents disseminated advertisements conveying the claims alleged in the Complaint

and that those claims were false or misleading, the next step is to determine whether those claims are material to

prospective consumers. Kraft, 970 F.2d at 314. “The basic question” on the issue of materiality “is whether the

act or practice is likely to affect the consumer's conduct or decision with regard to a product or service. If so, the

practice is material, and consumer injury is likely, because consumers are likely to have chosen differently but

for the deception.” Deception Statement, 1984 FTC LEXIS 71, at *171; see also Joint Stipulations of Law and

Facts, Stipulations of Law ¶ 4 (stipulating that “[a] ‘material’ misrepresentation or practice is one which is likely

to affect a consumer's choice of or conduct regarding a product”). In other words, information is material if it is

“important to consumers.” Deception Statement, 1984 FTC LEXIS 71, at *188.

Materiality is a test of the likely effect of the claim on the conduct of a consumer. Novartis Corp., 127 F.T.C. at

691. “Materiality turns upon whether those consumers who have drawn the claim from the advertisement and been

misled by it are also likely to have their conduct affected by the misrepresentation.” Id. To be material, “a claim

does not have to be the only factor or the most important factor likely to affect a consumer's purchase decision, it

simply has to be an important factor.” Id. at 683 (emphasis in original).

Complaint Counsel contends that the challenged claims are presumed to be material because, among other reasons,

the claims are “health-related efficacy claims.” CCB at 26-27. See Daniel Chapter One, 2009 FTC LEXIS 157,

at *245 (Initial Decision). Moreover, Complaint Counsel asserts, there is evidence, including Respondents' own

marketing surveys, demonstrating that the challenged claims are material. CCB at 28-29. Respondents contend that

regardless of whether a presumption of materiality applies in this case, Respondents have rebutted the presumption,

with survey evidence and expert opinion that the claims are not material to consumers' purchase decisions, and

that Complaint Counsel has failed to adduce evidence that the challenged claims are, in fact, material. Therefore,

Respondents argue, Complaint Counsel has failed to meet its burden of proof on materiality. RB at 82-92.

The presumption of materiality simply reflects the “general judgment that substantive claims in advertisements

(in other words, claims other than “puffery” or window-dressing) would not have been made except to affect a

consumer's choice of or conduct regarding a product. Thus, the very existence of the claim ordinarily is sufficient

evidence for the Commission to conclude it is material. “However, respondent is always free to counter this

evidence either with arguments pertaining to the content of the ad itself or with extrinsic evidence.” Thompson

Medical, 1984 FTC LEXIS 6, at *374 n.45.

*235 In Novartis, the Commission explained the operation of the presumption of materiality as follows:

Certain categories of information are presumptively material, including, but not limited to, express claims, claims

significantly involving health or safety, and claims pertaining to the central characteristic of the product. Deception
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Statement, 103 F.T.C. at 182. Similarly, the Commission will infer materiality where the record shows that

respondent intended to make an implied claim.

Id. ...

“To establish a ‘presumption’ is to say that a finding of the predicate fact, here, any of the factors listed above,

produces a required conclusion in the absence of explanation,” here, materiality. St. Mary's Honor Ctr. v. Hicks,

509 U.S. 502, 506 (1993) (internal quotation marks omitted). In order to rebut the presumption, respondent must

come forward with sufficient evidence to support a finding that the claim at issue is not material. Respondent can

present evidence that tends to disprove the predicate fact from which the presumption springs (e.g., that the claim

did not involve a health issue) or evidence directly contradicting the initial presumption of materiality. This is not

a high hurdle. Unless the rebuttal evidence is so strong that the fact finder could not reasonably find materiality,

the fact finder next proceeds to weigh all of the evidence presented by the parties on the issue. See id. at 516

(noting that after the presumption drops out, “the inquiry ... turns from the few generalized factors that establish

[the presumption] to the specific proofs and rebuttals ... the parties have introduced”). While the presumption itself

is negated by sufficient rebuttal evidence, as previously noted, the predicate facts that gave rise to the presumption

are not. These facts remain evidence from which materiality can be inferred. See Boise Cascade, 113 F.T.C. at

975 (1990). However, this evidence is simply part of the entire body of evidence considered. See also21 Charles

Alan Wright and Kenneth W. Graham, Jr., Federal Practice and Procedure: Evidence §§ 5122 et seq. (1977 and

1998 Supp.) (discussing the history and application of presumptions).

Novartis, 127 F.T.C. at 686-87.

Applying the principles of Novartis to the evidence in this case, it is unnecessary to rely on any presumption

because, as further discussed below, the preponderance of the evidence shows that the challenged claims are

material. Even if a presumption arises, and even if Respondents' evidence sufficiently rebuts the presumption, a

“weigh[ing] of all of the evidence presented by the parties on the issue” shows that the challenged claims would

be important to consumers, and likely to affect consumers' conduct or decisions. Novartis, 127 F.T.C. at 686.

Accordingly, because the evidence is sufficient to prove materiality in the instant case, irrespective of any legal

presumption, logic dictates that this Initial Decision need not, and it does not, analyze the effect of a presumption

of materiality in this case.

2. Evidence of materiality

*236 The evidence shows, and Respondents have failed to effectively rebut, the “predicate fact” that the

advertising claims at issue involve health-related matters; specifically, efficacy for disease or dysfunction,

and clinical proof of such efficacy. F. 580-583; see Novartis, 127 F.T.C. at 686-87. Common sense and

experience readily support the conclusion that Respondents' claims in this regard would be important to consumers

considering a purchase and likely affected consumers' decisions. Such a conclusion requires “no great leap.”

Novartis, 127 F.T.C. at 687.

Moreover, the evidence shows that advertising the results of studies related to heart disease, prostate cancer, and

erectile dysfunction resulted in sales and that Respondents were aware of this fact. F. 1317, 1321, 1323-1324, 1326.

See Kraft, 114 F.T.C. 40, 1991 FTC LEXIS 38, at *46 (finding that materiality was shown by evidence that the

challenged advertisement copy led to increased sales). For example, in evaluating how copy-dense or “medically

oriented” to make a planned POMx Pill advertisement, Diane Kuyoomjian, Senior Vice President of Marketing for

POM from 2008 to 2009, reminded Mrs. Resnick in a January 2009 e-mail: “[y]ou'll recall that a previous ad test

with less copy did not generate as many orders. That would suggest we keep the research info in the new ad, which

would make it information dense as well.” F. 1323. In addition, Ms. Leow, a creative director for Roll, stated
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that scientific information in advertising and marketing material helps sell the products, because the scientific

information provided the consumer with a “reason to believe.” F. 1326. See also F. 1321. (September 2006 press

article, stating “every time a new study [was] released touting” a health benefit of pomegranate juice, there was a

“spike in sales. The study ... linking the consumption of pomegranate juice to a reduction in prostate cancer was

especially helpful.”). Further, Mr. Resnick testified that POM communicates to consumers the “[company's] belief

that pomegranate juice is beneficial in treating some causes of impotence, for the purpose of promoting sales of

its product,” F. 1316, and he further acknowledged that the kinds of benefits revealed by POM's research results

are the primary reason people buy pomegranate juice. F. 1317; see also F. 1319 (draft creative brief describing

concept behind advertising dollars spent on research as, “We don't just say our product is great, we have clinical

studies that prove its efficacy”). Mr. Resnick also acknowledged that consumers buy pomegranate juice “because

they believe and in fact it does postpone the onset of prostate cancer, which postpones the onset of death.” F.

1317-1318.

In addition, in the ordinary course of business, POM conducted consumer research to understand the

characteristics, attitudes and usage habits of POM customers and to identify barriers and opportunities for

increasing consumption, particularly in relation to other brands of pomegranate juice. F. 1330. These studies also

support a conclusion that the challenged claims are material to consumers. See Kraft, 1991 FTC LEXIS 38, at *40

(relying on consumer survey evidence to finding of materiality). The 2009 OTX Attitudes and Usage Study (“OTX

A&U Study”) (F. 1331) found that, of the survey respondents that identified “health” as a reason for drinking

pomegranate juice, 47% of the POM Juice drinkers chose the further response, “helps protect against prostate

cancer.” F. 1332-1335. Similarly, in August 2007, Respondents commissioned a Zoomerang online survey of

the general public, “[t]o better understand pomegranate and non-pomegranate juice consumers,” with respect to,

among other things, “[i]mportance of certain health benefits.” F. 1342. Six health benefits were listed and these

survey respondents were asked to rank which was the most important to them personally. F. 1342. For heavy

pomegranate juice drinkers, the number one response, for both males and females was “cardiovascular,” and

the number two choice for men was “prostate.” F. 1342. For members of the general public responding to the

Zoomerang question regarding ranking of health benefits, 60% ranked cardiovascular health as the first or second

most important benefit, 40% of males ranked prostate health as the first or second most important benefit, and

approximately 18% of males did so for erectile dysfunction. F. 1343. While Respondents' marketing expert, Dr.

David Reibstein, criticized the methodology of using closed-ended questions, such as were used in the OTX A&U

Study, because they can “cue” the survey respondent to certain answers and inflate results, F. 1340, closed-ended

questions tend to be used when studying purchase motivations and have the advantage of allowing the researcher

to obtain specificity in the responses. F. 1341. The materiality survey relied on in Kraft also made use of similar

closed-ended questions. 1991 FTC LEXIS 38, at *40 (relying on survey asking respondents to rate the importance

of a claim that cheese was “a source of calcium”).

*237 Additional evidence of the materiality of Respondents' advertising claims is demonstrated by Respondents'

“creative briefs,” which served to direct the content of their advertising. F. 145-151. For example, a creative brief

for the POM Wonderful website, from approximately June 2008, shows that the purpose of the “Health Benefits”

section of the POM Wonderful website was to communicate the “heart health,” “prostate health,” and “E.D.”

“health benefits,” including by explaining how such benefits are provided. F. 1325. Further, in order to engage

website viewers, the “Health Benefits” section was to provide “expert” information on heart and prostate matters,

as well as a database of studies and results, searchable by subject matter, including heart and prostate. F. 1325;

see also F. 1327-1328 (creative briefs describing main creative focus for advertising assignments as “prostate

cancer”). Respondents' arguments that creative briefs cannot be relied upon because they reflect the opinions of

low level employees, is unsupported by the evidence, see e.g., F. 154, 181, and is unpersuasive.

Finally, in over a decade, POM sponsored over 100 studies at 44 different institutions, and over $35 million

has been invested in POM's research program. F. 128, 131. POM uses the results of studies it has sponsored
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for marketing purposes, as part of POM's “unique selling proposition.” F. 113. Considering these circumstances,

particularly that POM was aware that among those purchasing the POM Products were “people that have heart

disease or prostate cancer in their family, or have a fear of having it themselves,” F. 1320, it defies credulity to

suggest that Respondents would advertise study results related to these conditions if such advertising did not affect

consumer behavior. In fact, Respondents' marketing expert, Dr. Reibstein, stated that it was indeed possible, and he

would expect that, to consumers who were concerned about heart disease, prostate cancer, or erectile dysfunction,

a claim that drinking a bottle of POM Juice a day was effective for these conditions would be important to their

purchasing decisions. F. 1329.

3. Respondents' evidence of immateriality

Respondents rely on the results of the Reibstein Survey, which showed, among other things, that a very small

number of survey respondents (12 out of 750), when asked to identify their reasons for purchasing, repurchasing,

or recommending pomegranate juice, including POM Juice, identified a specific disease, and of those who did,

fewer still mentioned “heart disease” or “cancer.” F. 1344, 1351-1365. Based on these study results, Dr. Reibstein

expressed the opinion that there is a very small percentage of people that bought, would buy again, or would

recommend POM Juice to a friend because they believe that it cures or prevents a specific disease. F. 1372.

The Reibstein Survey obtained these results by asking a series of open-ended questions, such as: “Why did

you purchase POM Wonderful 100% Pomegranate Juice?” and asking survey respondents to provide “specific

details.” F. 1354. In this regard, the Reibstein Survey was flawed because it only assessed consumer motivations

generally; it did not actually assess whether any of the challenged claims in the Complaint would be important to

the survey respondent's decision to purchase the products. F. 1373. Moreover, the survey did not ask any followup questions, including of the 35.2% of POM Juice purchasers who stated that they bought or would repurchase

POM Juice because it was “healthy.” F. 1354, 1361, 1375. The failure to probe further as to what these survey

respondents meant by “healthy” and whether there were specific reasons or benefits that underlay their “healthy”

responses, constitutes methodological flaws that render the Reibstein Survey insufficiently probative to outweigh

the substantial, probative evidence, summarized above, showing that disease claims are likely to be important to,

and to influence, consumer decision making. See Kraft, 1991 FTC LEXIS 38, at *47 (rejecting materiality survey

as insufficiently probative because limited response options offered to survey participants failed to adequately

elicit all of the ways in which consumer conduct with respect to the product might be affected by the implied

claims at issue). A more probative survey on materiality would have provided survey respondents with a statement

about what the claim was, and inquired how important they think that claim would be to their potential purchase

decision, F. 1374, as did the survey in Kraft, 1991 FTC LEXIS 38, at *40. Also affecting the relative weight of

the Reibstein Survey is the fact that it was commissioned and designed for use in litigation, F. 1344, while the

OTX A&U Study and the Zoomerang online survey were conducted in the ordinary course of business. F. 1330,

1331, 1342.

4. Conclusion

*238 The evidence of materiality in the record outweighs Respondents' evidence of immateriality and, therefore,

Complaint Counsel has met its burden of proof on the third element of its deceptive advertising claim. Accordingly,

because Complaint Counsel has met its burden as to all three elements of a deceptive advertising claim, liability

has been established. The Initial Decision next addresses the appropriate remedy.

H. Remedy

1. General legal principles
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Having concluded that Respondents violated the FTC Act, that Act authorizes an order requiring respondents to

cease and desist from such acts or practices. 15 U.S.C. § 45(b); FTC v. Nat'l Lead Co., 352 U.S. 419, 428 (1957).

“As the Court has said many times before, the Commission may exercise only the powers granted it by the Act.

The relevant sections empower the Commission to prevent the use of unfair methods of competition and authorize

it, after finding an unfair method present, to enter an order requiring the offender ‘to cease and desist’ from using

such unfair method.” Nat'l Lead Co., 352 U.S. at 428 (1957) (internal citation omitted).

The purpose of a cease and desist order is to prevent the violations from being repeated, including by “creating

stringent monetary incentives (in the form of civil penalties) for its observance.” In re Litton Indus., Inc., No.

9123, 97 F.T.C. 1, 1981 FTC LEXIS 94, at *147 (Jan. 5, 1981); accord Thompson Medical, 1984 FTC LEXIS 6,

at *405-06 (describing order as appropriate “to prohibit and prevent [the respondent] from engaging in deceptive

acts or practices”). Thus, “‘[t]he Commission is not limited to prohibiting the illegal practice in the precise form in

which it is found to have existed in the past.”’ FTC v. Colgate-Palmolive Co., 380 U.S. 374, 395 (1965) (quoting

FTC v. Ruberoid Co., 343 U.S. 470, 473 (1952)). The FTC is permitted “to frame its order broadly enough to

prevent respondents from engaging in similarly illegal practices in future advertisements.” Colgate-Palmolive Co.,

380 U.S. at 395. “Having been caught violating the Act, respondents ‘must expect some fencing in.”’ Id. (quoting

Nat'l Lead, 352 U.S. at 431). The cease and desist order must be sufficiently clear so that it is comprehensible to the

violator, and must be reasonably related to the violations found to exist. Colgate-Palmolive, 380 U.S. at 392, 395.

Applying the foregoing principles, and after consideration of all the arguments of the parties and the entire record

of the case, the attached order, to be entered herewith (hereafter, “Order”), will serve to prohibit and prevent

Respondents from engaging in deceptive advertising practices in the future, is reasonably related to the unlawful

acts or practices found to exist, and is sufficiently clear and precise. The scope and terms of the Order are

substantially the same as was entered by the Commission, and upheld on appeal to the United States Court of

Appeals, to redress unsubstantiated disease claims in Daniel Chapter One, No. 9329, 2010 FTC LEXIS 11 (Jan.

25, 2010), review denied, Daniel Chapter One v. FTC, No. 10-1064, 2010 U.S. App. LEXIS 25496 (D.C. Cir.

Dec. 10, 2010), cert. denied, 131 S. Ct. 2917 (2011).

2. Respondents' preliminary arguments

*239 Respondents argue on various grounds that no cease and desist order should issue in this case, despite

violations having been found. These arguments are addressed below

a. Outliers

Respondents assert that no cease and desist order may issue in this case based on eight of the Challenged

Advertisements, which Respondents assert should be considered “outliers.” Respondents define these “outliers”

as advertisements run in the 2003-2006 timeframe, and not thereafter, in which the images and the language

regarding the health benefits of POM Juice were “more aggressive than was typical of Respondents.” RB at 67-68.

According to Respondents, no relief can be based upon these “outliers” because such advertisements have stopped

and Complaint Counsel has failed to demonstrate that such conduct will be repeated. RB at 68-69, citing FTC v.

Evans Products Co., 775 F.2d 1084, 1087 (9th Cir. 1985) (stating that past wrongs are not enough for the grant

of an injunction, and that an injunction will issue only if the wrongs are ongoing or likely to recur).

Respondents' argument is unconvincing. Of the eight asserted “outliers,” only four are among the Challenged

Advertisements found to have made the implied claims alleged in the Complaint: (1) CX0036 (“Cheat Death”

print advertisement); (2) CX0016 (“Drink and be healthy” print advertisement); (3) CX0314 (magazine wrap

advertisements); and (4) CX0034 (“Amaze your cardiologist” print advertisement). See F. 580-583. In addition,

even if the exact same advertisements have not been repeated, this does not mean that Respondents' violations
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will not be repeated, particularly in light of the fact that numerous advertisements disseminated after 2006 were

found to have made implied disease claims, without adequate substantiation. F. 307-308, 321, 328, 344, 365, 432,

580-583, 962, 1143, 1313-1314. That the form of the advertisements communicating these implied claims may

have changed is not persuasive evidence that Respondents' past wrongs are not likely to reoccur. Furthermore,

even if the “outliers” were not considered violations for purposes of injunctive relief, there would be sufficient

violations based upon other advertisements to justify injunctive relief in this case. Bristol-Meyers, 1983 FTC

LEXIS 64, at *250-51 (finding adequate number of deceptive advertisements to support the order, even though

the number was fewer than the number found by the ALJ); In re Fedders Corp., No. 8932, 85 F.T.C. 38, 71-72

(Jan. 14, 1975) (holding that one or two advertisements can be sufficient number of violations to support order).

Accordingly, Respondents' “outlier” defense is rejected.

b. Liability of Roll

Complaint Counsel argues that both POM and Roll are liable for the violations in this case and should both be

subject to a cease and desist order, based upon two alternative theories: the “common enterprise” theory, based

on the interrelated nature of the two corporate Respondents; and the “active participant” theory, based on Roll's

direct activities with regard to POM's advertising, including through Roll's internal advertising agency, allegedly

with knowledge of the deceptive nature of the POM advertisements. CCB at 54-56. Respondents contend that no

cease and desist order should issue against Roll. RRB at 169-171.

*240 It is well established that “[w]here one or more corporate entities operate in a common enterprise, each

may be held liable for the deceptive acts and practices of the others.” FTC v. Bay Area Bus. Council, Inc., No.

02-C-5762, 2004 U.S. Dist. LEXIS 6192, at *33-34 (N.D. Ill. Apr. 8, 2004) (finding a common enterprise where

the corporate defendants were owned by the same person, were operated by the same people, often shared offices,

did business under each other's names, accessed the same customer databases, shared and transferred proceeds as

needed, and were considered a collaborative effort by the owner), aff'd, 423 F.3d 627 (7th Cir 2005); Telebrands

Corp., 140 F.T.C. at 451 (Initial Decision) (“Corporate respondents acting in concert to further a common

enterprise are each liable for the acts and practices of the others in furtherance of the enterprise.”). To determine

whether a common enterprise exists, courts will consider a variety of factors including: “common control; the

sharing of office space and officers; whether business is transacted through a maze of interrelated companies;

the commingling of corporate funds and failure to maintain separation of companies; unified advertising; and

evidence that reveals that no real distinction exists between the corporate defendants.” Nat'l Urological Group,

645 F. Supp. 2d at 1182. Courts look for vertical or horizontal commonality. FTC v. Network Servs. Depot, Inc.,

617 F.3d 1127, 1142-43 (9th Cir. 2010) (noting evidence showing that the companies pooled resources, staff, and

funds; shared common owners and managers; and participated to some extent in a common venture).

Applying the foregoing principles, the evidence demonstrates that POM and Roll are a “common enterprise.” F.

12, 19-21, 27-28, 1380, 1382, 1384, 1386-1390. Among other things, Respondents Stewart and Lynda Resnick are

the sole owners of Roll and its affiliated companies, including POM Wonderful. F. 12. Mr. Resnick is Chairman

and President, and Mrs. Resnick is a director and Vice Chairman of Roll. F. 19. Mr. Resnick is also Chairman and

Chief Executive Officer of POM. F. 20-21. POM is headquartered in the same building as Roll, in many cases

with employees of both companies occupying the same floor. F. 1380. Roll provides risk management, human

resources, consulting, and travel services to POM without any reimbursement, and advertising and marketing

services have been provided by Roll to POM without necessarily receiving reimbursement. F. 1385. In addition, for

accounting purposes, Roll and its affiliated companies, including POM, were represented as being under common

control or ownership and have been included together on consolidated financial and tax statements. F. 1387.

Moreover, the Resnicks have had ultimate say over all business functions of both Roll and POM, including setting

policy and supervising the senior executives of both companies, disregarding corporate formalities. F. 1386.
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*241 Respondents fail to make any discernable argument that POM and Roll are not a common enterprise,

focusing their argument instead on whether Roll was an “active participant” in POM's advertising and/or had

actual or constructive knowledge of any deception. RRB at 169-171. Considering the facts clearly supporting

liability of Roll based on the common enterprise theory, Roll is jointly liable with POM and will be held to the

provisions of the attached Order. It is, therefore, unnecessary to determine whether or not Roll is also liable under

the “active participant” theory. Thus, this Initial Decision need not, and does not, include any conclusions or

analysis regarding that issue.

3. Liability of Individual Respondents

a. Applicable legal principles

“To obtain injunctive relief against an individual for a business entity's acts or practices, the FTC first must prove

the entity violated § 5. See Federal Trade Comm'n v. Think Achievement Corp., 144 F. Supp. 2d 993, 1009-11

(N.D. Ind. 2000), aff'd, 312 F.3d 259 (7th Cir. 2002). The FTC must further show the individual participated

directly in the business entity's deceptive acts or practices, or had the authority to control them. See Federal Trade

Comm'n v. Publishing Clearing House, Inc., 104 F.3d 1168, 1170 (9th Cir. 1997).” FTC v. Freecom Communs.,

Inc., 401 F.3d 1192, 1202-03 (10th Cir. 2005); FTC v. Amy Travel Serv., Inc., 875 F.2d 564, 573 (7th Cir. 1989).

An individual's authority to control the corporation's deceptive acts may be “evidenced by active involvement in

business affairs and the making of corporate policy, including assuming the duties of a corporate officer.” Amy

Travel Serv., 875 F.2d at 573.

b. Stewart and Lynda Resnick

While Respondents assert generally that no liability should attach to any of the individual respondents,

Respondents specifically address their argument only to the liability of Respondent Matthew Tupper, which is

discussed below. Applying the well-established principles of individual liability, summarized above, the evidence

amply supports the conclusion that both Respondents Lynda Resnick and Stewart Resnick actively participated

in the acts and practices found to have violated the FTC Act and/or had the authority over them. The Resnicks

are the sole owners of POM and Roll. F. 12. Mr. Resnick is the Chairman of both corporate entities, and the

Chief Executive Officer of POM with overall responsibility and control over the business, including setting the

budgets for marketing, advertising and medical research. F. 19-20, 22-23, 1393. He considers himself ultimately

responsible for whether advertising should or should not go out, although he delegated day-to-day responsibility

to Mr. Tupper. F. 25. In addition, Mr. Resnick has been involved at a high level with POM's advertising and

marketing campaigns, including on occasion seeing headlines before advertisements were disseminated, when

Mrs. Resnick has chosen to involve him, and has been intimately involved in POM's scientific research program.

F. 23, 26, 1392-1395. The facts support Mr. Resnick being subject to a cease and desist order in this case.

*242 Mrs. Resnick is a director and Vice Chairman of Roll. F. 27-28. According to Mrs. Resnick, when it comes

to marketing and creative issues, everyone has a “dotted line” to her. F. 35. Although Mrs. Resnick was not an

officer of POM, Mrs. Resnick participated in POM's business on almost a daily basis in the company's early years,

and on a weekly or biweekly basis thereafter and through 2010. F. 30. As of 2011, Mrs. Resnick was still the

chief marketing person at POM. F. 31. Mrs. Resnick has had a principal role in approving advertising content

since POM's inception. F. 143, 160-161, 166-168, 1399. For example, Mrs. Resnick requested that copies of all

advertising campaigns be submitted to her for final approval including headlines used in POM's advertisements.

F. 1399. Mrs. Resnick held regular creative meetings with the senior in-house representatives of POM and

Roll, including representatives of POM's marketing department, Roll's public relations department and Roll's

advertising agency, Fire Station, to review and approve advertising concepts. F. 33, 141-143. If there were disputes
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or issues to resolve regarding advertising decisions, the final authority was either Mr. or Mrs. Resnick; however, as

the overseer of all branding and marketing, Mrs. Resnick had the “final word” on advertising content and concepts.

F. 1397, 1400. See also F. 33-34. Moreover, Mrs. Resnick was involved in several of the specific advertisements

found herein to have violated the FTC Act. Mrs. Resnick was “very involved” in developing the POMx brochure,

identified as CX1426, Exhibit I “Antioxidant Superpill” package insert, when it was first produced; Mrs. Resnick

was involved in the approval of the print advertisement identified as CX0029 (“10 OUT OF 10 PEOPLE DON'T

WANT TO DIE”); Mrs. Resnick approved the headline for the POMx print advertisement headlined “The Only

Antioxidant Supplement Rated X”; and Mrs. Resnick approved the print advertisement identified as CX0031

(“Floss your arteries” print advertisement). F. 1401-1404. The evidence is more than sufficient for Mrs. Resnick

to be subject to a cease and desist order.

As the Commission stated in Telebrands Corp., “it is not only appropriate but sometimes preferable to make the

principal of a corporation subject to fencing-in so that the individual cannot circumvent the order by establishing a

new company with a different name.” 140 F.T.C. 278, 344 n.62. Accordingly, based on the Resnicks' participation

in and control over the acts and practices in this case, it is appropriate for them to be subject to a cease and desist

order individually, along with the corporate Respondents. Indeed, as to Mr. and Mrs. Resnick, Respondents fail

to articulate any factual or legal basis for a contrary result.

c. Matthew Tupper

i. “Control” as a mandatory prerequisite to finding individual liability of corporate officer

*243 Mr. Tupper has been an officer of POM since 2003, first with the title of Chief Operating Officer and

then with the title of President. F. 37-38. Mr. Tupper acknowledges that he was involved in POM's operations,

science research, and marketing. However, according to Mr. Tupper, none of these aspects of POM's business

were under his ultimate control, but rather were under the ultimate control of Mr. and/or Mrs. Resnick. RTB at 2,

6-8. Mr. Tupper acknowledges, as he must, that the applicable test for individual liability is met by evidence of

either participation in the deceptive practices at issue or authority to control them. RTB at 3-5. See, e.g., Freecom

Communs., 401 F.3d at 1203;Amy Travel Serv., 875 F.2d at 573. Mr. Tupper contends, however, that despite

being stated in the alternative, “in practice,” authority to control is the key factor for liability, not participation.

RTB at 3. To the contrary, “[e]ither participation or control suffices.” QT, 512 F.3d at 864. In Direct Marketing

Concepts, a case upon which Mr. Tupper relies, the court reaffirmed the “either/or” nature of the individual liability

test by rejecting the argument by the defendant co-owner of the corporation “that he did not edit the content

of advertising.” Relying on Freecom Communications, the court held it sufficient that the co-owner controlled

the corporations, and, therefore, “could have nipped the offending infomercials in the bud ....” 624 F.3d at 13.

Similarly, in Freecom Communications, upon which Mr. Tupper also relies, the court held that the lower court's

“finding that [the individual defendant] never personally [made the misrepresentations at issue] is beside the point

because the law did not require the FTC to make such a showing. To justify the imposition of injunctive relief

against the individual, the FTC is required to show the individual participated directly in the business entity's

deceptive acts or practices, or had the authority to control such acts or practices.” 401 F.3d at 1204.

21

Mr. Tupper further maintains that, despite the well-established rule that evidence of either participation or control

can support imposing individual liability, he is “unaware of any case” in which individual liability of a corporate

officer was based on participation alone, and cites cases in which the corporate officer was found liable based

on evidence of both participation by the corporate officer and authority to control the corporation. RTB at 4-5.

E.g., In re Universal Electronics Corp., No. 8815, 78 F.T.C 265, 1971 FTC LEXIS 55, at *65-66 (Jan. 28, 1971)

(Initial Decision) (finding that evidence demonstrated that officer formulated, directed, and controlled the acts and

practices of the corporate respondent; and that he was responsible for, familiar with, and personally participated

in, the specific acts and practices at issue); FTC v. Neovi, Inc., 598 F. Supp. 2d 1104, 1117 (S.D. Cal 2008) (stating
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that “the Court agrees with the FTC that [the individual defendants] had the authority to control the corporate

Defendants' unfair practices, [and] that they participated in those activities ....”); FTC v. Transnet Wireless Corp.,

506 F. Supp. 2d 1247, 1271-1272 (S.D. Fla. 2007) (concluding, based on evidence, that individual defendants had

“authority to control the corporation” and directly participated in the practices at issue); Amy Travel Serv., 875

F.2d at 574 (affirming individual liability of principal officers and shareholders where it was found they controlled

the corporations and where it was also “clear that [the individual defendants] were the ones behind the vacation

passport scheme,” including writing telemarketing scripts); FTC v. Publ'g Clearing House, Inc., 104 F.3d 1168,

1171 (9th Cir. 1997) (noting that individual defendant's activities as corporate officer “included obtaining and

signing PCH's business license and signing the fund-raising agreement between PCH and [a fraudulent charity

whose] application to conduct charitable solicitation identified [her] as the person in ‘direct charge of conducting

the solicitation”’). See generally cases cited at RTB 4-5. Mr. Tupper's cited cases do not support interpreting the

rule that “[e]ither participation or control suffices,” QT, Inc., 512 F.3d at 864, to mean that only “authority to

control” will suffice. Furthermore, consistent with the above-cited cases, individual liability is warranted in this

case because, as further discussed below, Mr. Tupper both participated in the deceptive advertising practices at

issue and had the authority to control POM's practices in this regard. See also FTC v. Consumer Alliance, Inc.,

No. 02C2429, 2003 U.S. Dist. LEXIS 17423, at *20-22 (N.D. Ill. Sept. 29, 2003) (finding individual liability

where the defendants reviewed, approved, and drafted telemarketing scripts used to deceive consumers and had

authority to supervise and discipline employees).

ii. Mr. Tupper's participation in and control over the practices at issue in this case

*244 On the issue of participation, the evidence shows that Mr. Tupper's responsibilities within POM included

implementing POM's direction with regard to health benefit advertising and the use of science in connection

with the advertising. F. 51. With respect to this advertising, Mr. Tupper was the “connecting piece” between

the marketing vision and the communication of the science. F. 51-52, 1409, 1411. Mr. Tupper participated in

meetings in which Fire Station and POM personnel presented and reviewed advertising concepts and advertising.

F. 156, 1419. Mr. Tupper has reviewed and given direction to POM's marketing staff on parts or elements of

creative briefs. F. 1417. Mr. Tupper reviewed advertising copy (including headlines), made changes to copy, and,

depending on the project, had final say over POM advertising content and which advertisements should or should

not run. F. 160, 162, 1420. Mr. Tupper led meetings to review advertising copy from a scientific perspective prior

to dissemination of the advertising. F. 1410, 1416. Sometimes, Mr. Tupper would provide the specific words to

use when presenting medical research facts, and in other instances, POM Marketing or Fire Station employees

would “take a stab at writing [this information] and send it to [Mr. Tupper] to approve.” F. 1421. Mr. Tupper

participated in drafting the Time magazine cover wraps found herein to have made the claims alleged in the

Complaint. F. 306-310, 581, 1431. Mr. Tupper also reviewed press releases prior to issuance. F. 1430. In addition,

as POM's President, Mr. Tupper attended most of the marketing meetings with Mrs. Resnick, which included

discussions of POM's scientific research. F. 142, 144, 1412. In fact, Mr. Tupper had a significant degree of

involvement in the research aspects of POM's business, and his responsibilities included discussing which research

areas are appropriate for funding, participating in the internal decision-making as to what research to fund, and

overseeing for POM the clinical trials on POM's products that were conducted by research institutions. F. 53,

1424-1429; see also F. 119 (finding and contacting scientific experts to conduct research). POM's former Senior

Vice President of Marketing, Ms. Kuyoomjian, relied on her conversations with Mr. Tupper to understand content

in POM's advertising regarding the relationship between POM advertisements and the scientific support for these

advertisements. She also relied on Mr. Tupper to be the “arbiter” of whether people felt POM's advertising was

accurate. F. 1414, 1418, 1421. Accordingly, Mr. Tupper's level of participation is more than adequate to support

individual liability for POM's deceptive advertisements. See Amy Travel Serv., 875 F.2d at 573 (affirming finding

proof of participation based on individual defendants' writing telemarketing script used in deception); Publ'g

Clearing House, 104 F.3d at 1171 (affirming lower court's finding of proof of participation based on individual

defendant's signing a contract used in a fraudulent scheme); Consumer Alliance, 2003 U.S. Dist. LEXIS 17423,
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at *20-22 (finding individual liability where the defendant reviewed, approved, and drafted telemarketing scripts

used to deceive); In re Griffin Sys., Inc., No. 9249, 117 F.T.C. 515, 1994 FTC LEXIS 76, at *25 (April 29,

1994) (finding participation based upon individual respondents' preparing solicitation materials that contained

misrepresentations, including making changes in the content of those materials). 22

*245 The evidence also demonstrates that Mr. Tupper had authority to control the practices of POM. Mr. Tupper

was an officer of POM and, in his capacity as an officer, Mr. Tupper, together with others, formulated, directed,

or controlled the policies, acts, or practices of POM. F. 37-38, 42. Mrs. Resnick considered Mr. Tupper her

partner at POM since 2003 and relied on him to oversee POM's marketing when she reduced her day-to-day

involvement beginning in 2007. F. 39, 1407. Mr. Resnick delegated the authority to decide which advertisements

should run to Mr. Tupper. F. 1406. Mr. Tupper was responsible for managing the day-to-day affairs of POM,

including management of the day-to-day operations of the POM marketing team. F. 25, 44. Mr. Tupper oversaw

and administered POM's budget for all departments, and had authority to sign checks and contracts on behalf

of the company. F. 45. Mr. Tupper had numerous POM employees reporting to him directly, including the vice

presidents for marketing, corporate communications, clinical development, and operations. F. 47-50. Mr. Tupper

had the authority to hire and fire POM employees, including the head of POM's marketing department, on his

own, or, depending on the situation, in consultation with either Mr. or Mrs. Resnick. F. 46. Thus, the evidence is

sufficient to show authority to control. Benrus Watch Co. v. FTC, 352 F.2d 313, 325 (8th Cir. 1965) (affirming

individual liability against officers who “formulated, directed, and controlled” the policies and practices of the

corporate respondents); accord In re Universal Electronics Corporation, 1971 FTC LEXIS 55, at *65-66 (Initial

Decision); FTC v. World Media Brokers, 415 F.3d 758, 764-65 (7th Cir. 2005) (finding that individual defendants'

assumption of duties of corporate officers, such as corporate signing authority, “establishe[d] a level of corporate

involvement sufficient to demonstrate” authority to control); FTC v. Bay Area Bus. Council, Inc., 423 F.3d 627,

636-38 (same); Consumer Alliance, 2003 U.S. Dist. LEXIS 17423, at *20-21 (finding liability where individual

had authority to control based upon hiring, supervision, and disciplinary authority over employees). Compare

QT, Inc., 448 F. Supp. 2d at 973-74 (finding FTC failed to meet burden under test for individual liability where

corporate secretary “did not participate directly in the deceptive acts and practices carried out by the corporate

Defendants” or “possess ‘a level of corporate involvement sufficient to demonstrate the requisite authority to

control the corporate defendants.”’ (citation omitted)).

Mr. Tupper's contention that he did not have “sole” or “ultimate” control of POM, RTB at 2, 7, even if true, is

not determinative. A similar argument was made and rejected in Griffin Systems, Inc., 1994 FTC LEXIS 76. In

that case, the evidence showed that the corporate officer, Mr. Giordano, like Mr. Tupper in this case, administered

the day-to-day affairs of the office, and, like Mr. Tupper, had duties including, among other things, hiring and

supervising employees, and advising employees about the challenged solicitation materials. 1994 FTC LEXIS 76,

at *4; see F. 25, 44, 46-50, 1414, 1418, 1421. The Commission found these facts sufficient to support individual

liability, despite evidence showing that the officer shared his authority with the other individual respondents in

that case. Id. at *23. The Commission explained:

*246 In support of their argument that it is inappropriate to hold Mr. Giordano individually liable for the actions

of Griffin, the respondents emphasize that Mr. Giordano was not in sole control of Griffin. We are not aware of

any authority indicating that sole control of a company is necessary to establish individual liability. Indeed, there

have been a number of cases in which more than one individual has been held to formulate, direct, and control

the practices of a single corporation.

Id. at *24. In the instant case, the evidence, summarized above, amply demonstrates that Mr. Tupper had sufficient

authority, particularly with regard to the content of advertisements, to control the practices at issue. Moreover,

Mr. Tupper does not cite to any evidence that he ever expressed concerns about, or objections to, the POM

advertisements at issue to Mr. or Mrs. Resnick or that any such concerns or objections were overruled by either
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of them. As in Griffin Systems, the evidence is clear that Mr. Tupper “was part of the inner circle that formulated,

controlled, and directed” POM and “therefore it is appropriate to place him under order.” Id.

iii. Breadth of cease and desist order

Mr. Tupper contends that it is unnecessary and unreasonable to bind him to a cease and desist order in addition

to the other Respondents. He asserts that extending the proscriptions in the order to any food, drug, or dietary

supplement would “potentially attach to any company he is associated with for the next twenty years” and, thereby,

“effectively ensure that no company, with interests in foods, drugs or supplements would ever employ” Mr.

Tupper. RTB at 9-10. This argument is unpersuasive. The Order binds Mr. Tupper personally, and his successors

or assigns. Order, Definitions para. 2. The cease and desist Order does not, by its terms, bind Mr. Tupper's future

employers. 23

In addition, Mr. Tupper contends that the proposed order is unreasonable and overbroad as applied to him,

based upon his asserted limited control over and participation in the challenged practices, when considering the

seriousness of the conduct, the deliberateness of the conduct and its transferability to other products. RTB at 10-12;

see Telebrands, 457 F.3d at 358. As noted above, Mr. Tupper's participation in and control over the deceptive

practices at issue in this case is more than sufficient to justify a cease and desist order against him. The Telebrands

factors are analyzed below in Section III.H.4.a.

4. Provisions of the Order

Having determined that a cease and desist order is required against POM, Roll, Mr. and Mrs. Resnick, and Mr.

Tupper, this section of the Initial Decision addresses the specific provisions of the Order. The provisions of the

Order are substantially the same as Complaint Counsel's proposed order, which is the Notice Order that was

attached to the Complaint issued in this case (hereafter, “proposed order”), except that the Order does not include

Complaint Counsel's proposed part I, as further explained in Section III.H.4.b.

a. Multi-product coverage (Order, Definitions para. 5)

*247 The FTC's authority includes power to issue orders “encompassing all products or all products in a broad

category, based on violations involving only a single product or group of products.” ITT Continental Baking Co.

v. FTC, 532 F.2d 207, 223 (2d Cir. 1976).

Coverage of all products in a broad category is a means of “fencing-in” one who has violated the statute. Fencingin provisions serve to “close all roads to the prohibited goal, so that (the FTC's) order may not be by-passed with

impunity.” FTC v. Ruberoid Co., 343 U.S. 470, 473, 72 S. Ct. 800, 803, 96 L. Ed. 1081 (1952) (footnote omitted).

Fencing-in provisions must bear a “reasonable relation to the unlawful practices found to exist.” FTC v. ColgatePalmolive Co., 380 U.S. at 394-95, 85 S. Ct. at 1047-1048 (footnote omitted).

Litton Indus., Inc. v. FTC, 676 F.2d 364, 370 (9th Cir. 1982).

In determining whether a fencing-in order bears a “reasonable relationship” to a violation of the FTC Act,

courts and the Commission consider: (1) the degree of transferability of the violation to other products; (2) the

deliberateness and seriousness of the violation; and (3) any history of prior violations. Telebrands, 457 F.3d at

358;Kraft, 970 F.2d at 326. “The reasonable relationship analysis operates on a sliding scale -- any one factor's

importance varies depending on the extent to which the others are found. In other words, the more serious a

violation, the less important transferability and prior history become .... All three factors need not be present for a

reasonable relationship to exist.” Telebrands Corp., 457 F.3d at 358-59 (citation omitted). “[T]he more egregious
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the facts with respect to a particular element, the less important it is that another negative factor be present. In

the final analysis, [courts] look to the circumstances as a whole and not to the presence or absence of any single

factor.” Sears, Roebuck & Co. v. FTC, 676 F.2d 385, 392 (9th Cir. 1982); see also Kraft, 970 F.2d at 327.

Applying the foregoing principles to the facts of this case, and as discussed below, the Order's provisions will

apply to the POM Products as well as to any other food, drug or dietary supplement products sold by POM and

the other Roll entities. See Order, Definitions para. 5.

(i) Transferability

As the Commission stated in Litton Industries,

The rationale for entry of a multi-product order based upon violations in the advertising of only one or a few

products is that many kinds of deceptive advertising are readily transferrable to a variety of products, and it would

serve the public poorly to halt the use of a deceptive tactic in the advertising of one product if the respondent

remained free to repeat the deceptive practice in another guise, with no threat of sanction save for another order

to cease and desist. FTC v. Colgate-Palmolive Co., 380 U.S. at 394-95 (1965).

*248 Litton Indus., Inc., 1981 FTC LEXIS 94, at *147. Indeed, the “prevention of ‘transfers' of unfair trade

practices is a fundamental goal of the Commission's remedial work.” Sears, Roebuck, 676 F.2d at 394. Where

a violation has been demonstrated, “the Commission need not wait until a ‘transfer’ occurs” to other products.

Id. at 395.

A violation is considered transferable when other products could be sold utilizing similar techniques. ColgatePalmolive, 380 U.S. at 394-95;Sears, Roebuck, 676 F.2d at 392. For example, “misrepresenting that doctors prefer

a product, or that tests prove the product's superiority, is a form of deception that could readily be employed for

any non-prescription drug product.” American Home Prods. v. FTC, 695 F.2d 681, 708 (3rd Cir. 1982). In the

instant case, this transferability factor weighs strongly in favor of a multi-product order. As in Daniel Chapter

One, Respondents' advertising techniques “could readily be employed” for any food, drug or dietary supplement.

Daniel Chapter One, 2009 FTC LEXIS 157, at *284 (Initial Decision).

Respondents argue that the POM Products are only a small portion of the products Respondents sell. RRB at

204-205. Such assertion, even if true, is not material to whether the advertising claims made for the POM Products

are nevertheless transferable to the other categories of products that are covered by the Order and that are sold by

POM and/or the affiliated Roll entities, such as other pomegranate-based products (sold by POM); citrus fruits

(sold by Paramount Citrus), nuts (sold by Paramount Farms); bottled water (sold by FIJI Water); and wine (sold by

Justin Vineyards). F. 56, 1378. Standard Oil v. FTC, 577 F.2d 653 (9th Cir. 1978), upon which Respondents rely,

is readily distinguishable because in that case, as the court stated, “[t]he over-breadth of the order results from its

coverage of “any ... product in commerce” which is advertised by Standard ....” Id. at 661. In the instant case, the

Order is limited to Respondents' advertising of food, drugs and dietary supplements. Order, Definitions para. 5.

Respondents further contend that their other products that do not involve pomegranates, such as citrus fruits,

water, nuts and wine, are so “dramatically different” from the POM Products that Respondents would not use

POM research to understand any components of such products. RRB at 205-206. Even if true, this contention

is beside the point because the advertising technique, i.e., sponsoring research of a product's health benefits and

using the results to make disease claims, is readily transferable to advertising any food, drug or dietary supplement.

In this regard, Respondents admit that they have sponsored “research exploring the health benefits of Wonderful

Pistachios and Fiji Water” but assert that they have a “history” of “not advertising those benefits until the science

is sufficiently developed.” RRB at 207. This case demonstrates, however, that Respondents' judgment as to what
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constitutes advertising “health benefits” as opposed to what constitutes advertising a scientifically proven effect

for disease, has not always been exercised appropriately.

*249 Finally, Respondents assert that the deceptive claims found to have been made in this case are “peripheral”

to their advertising strategy, and that their central advertising and marketing strategy has evolved away from health

advertising and more toward “history” and “sexuality.” RRB at 208. However, Respondents' asserted change of

strategy does not make their past advertising themes and techniques any less transferable. As previously noted,

such themes and the techniques used to communicate them are fully transferable — whether Respondents may

opt to engage in other strategies in the future is not determinative.

Thus, the ease of transferability strongly supports the provisions in the Order making the Order applicable to any

food, drug, or dietary supplement products.

(ii) Seriousness and deliberateness

The seriousness of the Respondents' conduct is evidenced by the fact that the deceptive advertising claims found

to have been made in this case pertained to serious diseases and dysfunction of the body, including cancer. See

Daniel Chapter One, 2009 FTC LEXIS 157, at *282 (Initial Decision); see also Stouffer, 1994 FTC LEXIS 196,

at *39 (holding that deceptive low sodium health claim was serious because of overall health ramifications). The

seriousness of Respondents' conduct is further demonstrated by the inability of consumers to evaluate whether

Respondents' implied disease claims are true or actually supported by cited studies. Id.; Thompson Medical, 1984

FTC LEXIS 6, at *417. Thus, Respondents' claims concerning product effectiveness and clinical proof are “ones

to which consumers were particularly susceptible.” Id.; see also Litton Indus. Inc., 1981 FTC LEXIS 94, at *150

(holding that use of survey results to support claim of product superiority has considerable potential to deceive,

and, therefore, misuse of surveys in this regard is a serious violation). Respondents' assertion that consumers can

access the identified studies themselves, RRB at 181, even if true, is not persuasive evidence that consumers can

accurately assess the significance of the studies, much less in relation to Respondents' advertising claims.

The deliberateness of Respondents' conduct is also shown by the consistency of Respondents' advertising themes

over the years, which supports a conclusion that the advertisements found herein to have violated the FTC Act did

not constitute accident or an “isolated instance.” Thompson Medical, 1984 FTC LEXIS 6 at *417. Respondents'

contention that representations in certain advertisements were the result of mistake, RRB at 182; see RB at 67-68,

even if assumed to be true, is insufficient to support a conclusion that Respondents' violations on the whole were

accidental or inadvertent. Moreover, while it is arguable that the language used to make their advertising claims

became less “aggressive” over the years, as Respondents contend, RB at 67-68; RRB at 182, there is little doubt

that a central, and persistent, theme of Respondents' advertising was the POM Products' purported ability to affect

diseases and dysfunction, and the scientific studies purportedly showing such effects. See, e.g., Appendix to Initial

Decision; F. 145-151. In addition, the advertising appeared in a wide variety of national and local media, for

multiple years. F. 169-170, 291, 297, 307-308, 321, 328, 344, 365, 416, 421, 428, 432, 440, 449, 456, 469, 580-583.

See Sears, Roebuck, 676 F.2d at 394 (in upholding multi-product order, noting that advertising campaign cost $8

million, ran for four years, and appeared in magazines, newspapers and on television throughout the country);

Daniel Chapter One, 2009 FTC LEXIS 157, at *281 (Initial Decision) (noting that respondents made numerous

deceptive representations over the Internet, in their publications, and through the DCO radio program, over the

course of several years).

*250 Respondents contend that POM's internal procedures for evaluating its advertisements and science should

also be considered. Specifically, Respondents point to testimony that since 2007, POM has implemented a more

formalized vetting process for advertisements relating to the health benefits of its products, which requires multiple

stages of review that ultimately culminate in approval by the legal department before any advertisement is run.
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(Tupper, Tr. 2977-78). The evidence shows, however, that a number of the advertisements found to have violated

the FTC Act were disseminated after 2007, when Respondents' review process was purportedly implemented. F.

307-308, 321, 365, 580-583, 962, 1143, 1313-1314. Therefore, it cannot be concluded, as Respondents urge, that

their internal processes will ensure that only accurate information will be presented to the public in the future. 24

(iii) Prior violations

There is no evidence of prior violations of the FTC Act by Respondents. However, as noted above, all of the

three relevant elements need not be present to warrant a multi-product order. Telebrands Corp., 457 F.3d at

358-59. Courts look to the circumstances as a whole “and not to the presence or absence of any single factor.”

Sears, Roebuck, 676 F.2d at 392. In Telebrands, the Court of Appeals upheld the Commission's conclusion

that the strength of the evidence as to the first two factors sufficiently established that there was a reasonable

relationship between the remedy and the violation, and it was not necessary to also consider any prior consent

orders. Telebrands Corp., 457 F.3d at 362. Thus, while here there is no history of violations in this case, that

factor is less important, taking into account the strength of the other relevant factors, particularly the ease of

transferability to other products.

b. Part I of the Order

Part I of the Order prohibits Respondents from making representations that any Covered Product, as defined

in the Order, “is effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease, including,

but not limited to, any representation that the product will treat, prevent, or reduce the risk of” heart disease,

prostate cancer, or erectile dysfunction, “unless, at the time it is made, the representation is non-misleading and,

Respondents possessed and relied upon competent and reliable scientific evidence that is sufficient in quality and

quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the

entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.” Order, Part I.

“Competent and reliable scientific evidence” is defined in the Order to mean “tests, analyses, research, or studies,

that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures

generally accepted in the profession to yield accurate and reliable results.” Definitions, para. 4. Commission orders

requiring respondents to have competent and reliable scientific evidence, as defined in this Order, that is based on

the expertise of professionals in the relevant area and that has been conducted and evaluated by persons qualified

to do so, are typical and have been consistently upheld by the appellate courts. E.g., Daniel Chapter One, 2010

FTC LEXIS 11, review denied, 2010 U.S. App. LEXIS 25496 (D.C. Cir. 2010); Telebrands Corp., 140 F.T.C. at

347, aff'd, 457 F.3d 354 (4th Cir. 2006); In re Kraft, 1991 FTC LEXIS 38, at *59-60, aff'd, 970 F.2d 311 (7th Cir.

1992). Such a requirement in this case serves the purpose of preventing future violations, is reasonably related

to the violations found to exist, is sufficiently clear and precise, and is amply supported by legal precedent and

the facts of this case.

c. Part I of the proposed order (FDA pre-approval substantiation requirement)

(i) Overview

*251 Part I of the Order entered herewith differs from Part I of Complaint Counsel's proposed order. Part I

of the proposed order would prohibit Respondents from making any representation that any POM Product “is

effective in the diagnosis, cure, mitigation, treatment, or prevention of any disease, including, but not limited to,

any representation that the product will treat, prevent, or reduce the risk of” heart disease, prostate cancer, or

erectile dysfunction, unless, at the time it is made, the representation is non-misleading and:

A. the product is subject to a final over-the-counter (“OTC”) drug monograph promulgated by the Food and Drug

Administration (“FDA”) for such use, and conforms to the conditions of such use;
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B. the product remains covered by a tentative final OTC drug monograph for such use and adopts the conditions

of such use;

C. the product is the subject of a new drug application for such use approved by FDA, and conforms to the

conditions of such use; or

D. the representation is specifically permitted in labeling for such product by regulations promulgated by the FDA

pursuant to the Nutrition Labeling and Education Act of 1990 [“NLEA”].

As Complaint Counsel explains, part I of the proposed order:

provides that the necessary substantiation for future claims that any POM Product is effective in the diagnosis,

cure, mitigation, treatment, or prevention of any disease — including heart disease, prostate cancer, or erectile

dysfunction — is FDA approval, which may be provided in the form of a tentative final or final over-the-counter

(“OTC”) drug monograph, a new drug application, or labeling approval under regulations promulgated pursuant

to the Nutrition Labeling and Education Act of 1990 (“NLEA”). For example, a claim that POM Juice reduces

the risk of heart disease would need to be supported by an FDA regulation authorizing such a claim in labeling.

CCB at 62-63. Complaint Counsel refers to these provisions as the “requirement of FDA preapproval.” CCB at

64-65. (hereafter, “FDA pre-approval requirement”).

Complaint Counsel further explains that, under the proposed order, if Respondents “make a qualified claim, one

that characterizes the limited scientific evidence supporting a relationship between a POM product and reductions

in disease risk in a careful manner that eliminates any misimpression that a POM product actually reduces risk,”

then the substantiation they must possess is “competent and reliable scientific evidence,” as provided under part III

of Complaint Counsel's proposed order. CCRB at 50-51 (emphasis in original). However, “[i]f Respondents make

[an] unqualified disease claim” in the future that any POM Product “is effective in the diagnosis, cure, mitigation,

treatment, or prevention of any disease,” then the “substantiation [Respondents] must possess for their claims

would be FDA preapproval.” CCRB at 50 (emphasis in original). Thus, pursuant to part I of the proposed order,

the FTC would determine (and ultimately have to prove at a contempt proceeding in court) whether Respondents

made an “unqualified” disease claim, as opposed to a “qualified” “limited” and “careful” claim, and unless the

FDA has already determined, applying FDA regulations, that Respondents' substantiation was adequate for that

claim, then Respondents would be in violation of the FTC order. March 6, 2012 Tr. 67 (closing arguments).

*252 As more fully discussed below, Complaint Counsel argues that its proposed FDA pre-approval framework

is a form of fencing-in that is reasonably related to the violations in this case, is clear and concise, and provides

a necessary “bright-line” rule for future claims. Id. at 66-67; CCB at 62-65. Respondents oppose the FDA preapproval requirement on a variety of grounds, including that the requirement is unlawful because it exceeds

the authority granted the FTC under the FTC Act and would violate Respondents' First Amendment freedom to

engage in commercial speech. RB at 98-99; RRB at 210-218. Complaint Counsel has failed to demonstrate that

the proposed FDA pre-approval requirement is necessary or appropriate for this case, as further explained below.

No previous decision by the Commission or any court has required FDA pre-approval as the required level of

substantiation, including for purposes of a cease and desist order. Most recently, in Daniel Chapter One, in which
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the respondents were found to have made unsubstantiated disease claims in violation of Sections 5 and 12 of the

FTC Act, the Commission entered an order prohibiting them from making such claims in the future “unless the

representation is true, non-misleading, and, at the time it is made, Respondents possess and rely upon competent

and reliable scientific evidence that substantiates the representation.” 2010 FTC LEXIS 11, at *3. This is also

the standard adopted in the Order entered herewith. See Order Parts I and III. “Competent and reliable scientific

evidence” was defined in the order entered in Daniel Chapter One, as in the instant Order, as “tests, analyses,

research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been

conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted

in the profession to yield accurate and reliable results.” 2010 FTC LEXIS 11, at *1. 25 See Order, Definitions

para. 5. Daniel Chapter One is clear authority for entering an order in this case requiring competent and reliable

scientific evidence to substantiate disease claims. Indeed, the competent and reliable scientific evidence standard

was deemed sufficient to redress the conduct in Daniel Chapter One, which was arguably more egregious than that

presented by the instant case. The implied claims in Daniel Chapter One, unlike the instant case, were found to

have been “so strongly implied as to be virtually express.” 2009 FTC LEXIS 157, at *53, 55 (Initial Decision). In

addition, unlike the instant case, the respondents in Daniel Chapter One conducted no testing on the effects of the

challenged products, much less clinical testing, and the scientific substantiation relied upon by those respondents

consisted of nothing more than compilations of citations to literature, mostly non-peer-reviewed papers, on the use

of herbal medicines for a number of different diseases. Id. at *237-39; compare F. 732, 756, 1010, 1185. Moreover,

in Daniel Chapter One, unlike the instant case, the respondents urged their customers to forgo medical treatment

and instead use their products to treat cancer as an alternative to pursuing established medical treatments. Id. at

*282-83. Complaint Counsel's arguments in support of deviating from the order entered and upheld in Daniel

Chapter One are addressed below. 26

(ii) Complaint Counsel's “reasonably related” justification for FDA pre-approval requirement

*253 Complaint Counsel contends that requiring FDA pre-approval for disease claims is “reasonably related”

to the violations in this case because (1) the FDA's standard for labeling approval for a food-disease relationship

claim under NLEA (“significant scientific agreement” by experts that the claim is supported) is “cited” in the

FTC Enforcement Policy Statement on Food Advertising; and (2) the FDA standard for drug approval under the

Food, Drug and Cosmetic Act (“adequate and well-controlled” clinical investigations by experts demonstrating

effectiveness), is “similar” to the “competent and reliable scientific evidence” standard applied in Daniel Chapter

One, and referred to in the FTC publication, Dietary Supplements: An Advertising Guide for Industry. However,

the foregoing FTC publications do not constitute regulatory law, which is made either by adjudication, 15 U.S.C.

§45(b); 5 U.S.C. § 556, or by promulgated regulation, 15 U.S.C. §57b-3; 5 U.S.C. §553.

27 See Ford Motor Co. v.

FTC, 673 F.2d 1008, 1009 (9th Cir. 1981) (noting that an administrative agency such as the FTC may announce

principles through adjudication or rulemaking (citing NLRB v. Bell Aerospace Co., 416 U.S. 267, 294 (1974)).

The standard for substantiation for disease claims that has been reflected in adjudication is the “competent and

reliable scientific evidence” standard, based on the opinions of experts in the relevant fields, as applied in this

case and as affirmed most recently in Daniel Chapter One.

Moreover, as explained in Section III.F.2 of this Initial Decision, applicable case law clearly establishes that the

required level of substantiation is a question of fact, based upon evidence on numerous factors, including the

nature of the product, the safety of the product, the overall context in which the transaction occurs, and what

experts in the relevant field would consider sufficient to support the claim at issue. E.g., QT, Inc., 448 F. Supp.

2d at 959;FTC v. Braswell, 2005 U.S. Dist. LEXIS 42976, at *35; Thompson Medical, 1984 FTC LEXIS 6, at

*387. In the instant case, after conducting the trial, and thoroughly reviewing the evidence and the voluminous

transcript and record, it has been determined that the required level of substantiation for Respondents' implied

disease claims is “competent and reliable scientific evidence,” as defined by experts in the respective fields, and

that such evidence does not require RCTs, such as those that would be required under FDA standards, because
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such claims were made for a safe food product that was not being urged as a substitute for medical treatment

or advice. See F. 693, 694-710, 963, 1147-1148. This Initial Decision has not determined that FDA standards

are the required level of substantiation for the implied disease claims found to have been made in this case, nor

have Respondents been held liable herein for failing to meet FDA standards. Rather, it has been determined that,

applying the competent and reliable scientific evidence standard, as defined by the experts in the respective fields,

Respondents' substantiation was inadequate to support the implied disease claims found to have been made in

this case and, therefore, Respondents violated the FTC Act. To the extent that part I of the proposed order seeks

to impose a different and/or higher level of substantiation for future implied disease claims, which it effectively

would do, part I of the proposed order is not reasonably related to the violations found to exist. See Daniel Chapter

One, 2009 FTC LEXIS 259, at *70 (stating that order's requirement that “Respondents possess and rely upon

competent and reliable scientific evidence that substantiates” their claims “only obliged [them] to do that which

the case law under Sections 5 and 12 of the FTC Act has defined as necessary to avoid deception”). 28

*254 Similarly, Complaint Counsel asserts that it is proper to defer to FDA standards and evaluation of scientific

evidence because such deference “is consistent with prior Commission practice.” CCB at 63-64. Complaint

Counsel cites Thompson Medical, in which the Commission noted that it was “additionally persuaded” that two

well-controlled clinical tests was the correct level of substantiation for drug efficacy claims because “this is the

standard currently being required ... by the FDA” and advertisers of drug products will benefit from “greater

regulatory certainty.” Thompson Medical, 104 F.T.C. at 826, 1984 FTC LEXIS 6, at *398. In the instant case,

however, as noted above, the evidence failed to show that RCTs were required to substantiate Respondents' implied

claims because, among other reasons, the POM Products are food, or food-derived products, and were not being

urged as an alternative to medical care or advice. F. 693, 694-710, 963, 1147-1148. Thus, Thompson Medical does

not support imposing the proposed FDA pre-approval requirement in the Order in this case. 29

(iii) Complaint Counsel's “bright-line rule” justification for FDA pre-approval requirement

Complaint Counsel further argues that the FDA pre-approval requirement is justified because it is “clear and

precise,” as required under Colgate-Palmolive. According to Complaint Counsel, FDA pre-approval is a “brightline rule” that will “significantly increase ... enforceability,” “eliminate any confusion or ambiguities over the

appropriate standard that Respondents must have to make disease claims” and prevent litigation. CCB at 64-65,

67. However, neither FDA pre-approval, nor FDA standards for obtaining such approval, constitutes the required

level of substantiation under the FTC Act or applicable case law. Nor have FDA standards been found to constitute

the required level of substantiation based on the evidence in the instant case. Thus, the “bright-line” proposed

by Complaint Counsel would be imprudently drawn in this case. Moreover, “the complexity of the scientific

issues, the unquestioned expertise of the FDA to evaluate scientific evidence relating to disease claims, and the

Commission's interest in harmonizing with the FDA,” CCB at 67, do not constitute sufficient reasons to create

a new level of substantiation, through a cease and desist order against Respondents, a fortiori, considering the

level of substantiation found to be required in this case. Indeed, the Second Circuit Court of Appeals has indicated

that a “bright-line” of FDA approval for FTC cease and desist orders is “unnecessary, if not undesirable.” BristolMeyers Co. v. FTC, 738 F.2d 554, 560 (2d Cir. 1984). In that case, the court rejected Bristol-Meyers' request to

modify the FTC's cease and desist order to permit it to rely on demonstrating FDA approval of claims for its overthe-counter analgesics, stating: “FDA determinations are usually complex and subject to varying interpretations.

To allow [respondents] to rely on its evaluation of these determinations could conceivably lead to more deceptive

advertisements and to more disputes with the FTC.” Id. The reasoning in Bristol-Meyers is equally applicable

in the instant case, where Complaint Counsel seeks to replace the governing “competent and reliable scientific

evidence” standard with FDA approval standards. 30

*255 In addition, Complaint Counsel misconstrues the purpose of the requirement that FTC orders be “clear and

precise.” The Court in Colgate-Palmolive explained that “an order's prohibitions ‘should be clear and precise in
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order that they may be understood by those against whom they are directed ....”’ 380 U.S. at 392 (emphasis added)

(citation omitted). This language does not indicate that the “clarity and precision” requirement is designed for

the benefit of the FTC in litigating potential future enforcement actions. Moreover, some level of uncertainty is

contemplated by the FTC Act, as noted by the Supreme Court in Colgate-Palmolive: “If, however, a situation arises

in which respondents are sincerely unable to determine whether a proposed course of action would violate the

present order, they can, by complying with the Commission's rules, oblige the Commission to give them definitive

advice as to whether their proposed action, if pursued, would constitute compliance with the order.” 380 U.S. at

394;Kraft, 970 F.2d at 326 (citing the ability to seek an advisory opinion under 16 C.F.R. § 2.41(d) as a method

of reducing advertiser uncertainty). 31 Moreover, whatever bright-line rule might be applied to substantiation

will not necessarily reduce the risk of future litigation over whether Respondents made disease claims in the

first place. As this case demonstrates, there is ample room for disagreement over whether or not advertisements

make “unqualified” disease claims, as opposed to “qualified” “health benefit” claims, and the task of interpreting

advertisements clearly does not lend itself to a bright-line rule.

In any event, Complaint Counsel cites no authority supporting a conclusion that the competent and reliable

evidence standard, as provided in the Order upheld in Daniel Chapter One, is insufficiently clear or precise.

In Colgate-Palmolive, the Supreme Court upheld the FTC order's requirement of a “test, experiment or

demonstration” to substantiate future claims, and rejected the lower court's finding that such provision was invalid

as too difficult to interpret. 380 U.S. at 393-94. The Court stated: “We believe that respondents will have no

difficulty applying the Commission's order to the vast majority of their contemplated future commercials.” Id.

at 394.See also Bristol-Meyers Co., 738 F.2d at 560 (rejecting argument that order's requirement of “reasonable

basis” substantiation “to consist of ‘competent and reliable scientific evidence”’ was unduly vague). Indeed,

Complaint Counsel's proposed order expressly relies on the competent and reliable evidence standard, albeit for

claims other than disease claims, pursuant to proposed part III, and this standard has been incorporated into the

Order for all claims governed by the Order. For all the foregoing reasons, there is no basis for concluding that the

competent and reliable evidence standard is insufficiently clear or precise for purposes of enforcement.

*256 Complaint Counsel further argues that a “bright-line” rule is necessary because, according to Complaint

Counsel, Respondents have shown a willingness to “flout the law,” including, among other allegations, that

Respondents failed to make any specific changes to their advertising in response to an FTC warning letter sent to

Respondents in January 2008 and an FDA warning letter sent in January 2010. CCB at 65-66. The evidence upon

which Complaint Counsel relies, even if true, indicates a disagreement between the Respondents and regulatory

authorities regarding whether Respondents' advertising made disease claims and if so, whether those claims were

adequately substantiated. See id. The disagreement with the FTC culminated in this litigation, in which neither

side's position, as to the claims made or the adequacy of the substantiation, has been totally vindicated. Under

these circumstances, Respondents' choice not to “heed warnings” and instead to litigate is not fairly interpreted as

a willingness to “flout the law” but could be interpreted as an allowable choice made within the system as it exists.

(iv) Summary

Considering the entire record in this case, implementing Complaint Counsel's proposed FDA pre-approval

requirement would constitute unnecessary overreaching. The competent and reliable evidence standard is

established precedent, is reasonably related to the violations found to exist, and is sufficiently clear and precise to

guide Respondents' future advertising practices. Precedent does not support implementing an FDA pre-approval

requirement as a “bright-line” rule in this case. If Respondents choose to go “perilously close to an area of

proscribed conduct,” then they will “take the risk that [they] may cross the line.” Colgate-Palmolive, 380 U.S.

at 393.

32

d. Part II of the Order
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Part II of the Order, consistent with the proposed order, prohibits Respondents from misrepresenting “the

existence, contents, validity, results, conclusions, or interpretations of any test, study, or research.” One of the

violations alleged and proved in this case is that Respondents impliedly represented they had clinical proof of the

effectiveness of the POM Products, when such clinical proof was not, in fact, adequate to substantiate this implied

claim. Requiring Respondents to ensure that any advertised research results are fully accurate and non-misleading

is reasonably related to this violation. In their Post-Hearing Briefs, Respondents do not articulate any argument

for concluding that the provision is not reasonably related to the violations found in this case.

e. Part III of the Order

Part III of the Order, consistent with the proposed order, prohibits Respondents from making any representation

about the “health benefits, performance, or efficacy of any Covered Product” unless the claim is not misleading,

and supported by “competent and reliable scientific evidence that is sufficient in quality and quantity based on

standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant

and reliable scientific evidence, to substantiate that the representation is true.” This provision is reasonable and

appropriate, and obliges Respondents only “to do that which the case law under Sections 5 and 12 of the FTC Act

has defined as necessary to avoid deception.” Daniel Chapter One, 2009 FTC LEXIS 259, at *70. Respondents,

in their Post-Hearing Briefs, do not articulate any argument against applying this standard to future advertising

claims within the scope of Part III.

f. Miscellaneous provisions

*257 Part IV of the Order, consistent with the proposed order, provides that nothing in the Order prohibits

Respondents from making claims that are specifically permitted in labeling, pursuant to FDA standards and

regulations. In contrast to Complaint Counsel's proposed and rejected FDA pre-approval requirement, which made

FDA standards the minimum substantiation for disease claims, this provision properly gives Respondents a “safe

harbor” against any future FTC challenge to Respondents' advertising representations, by enabling Respondents

to demonstrate FDA approval. Substantially the same provisions were entered in the Order in Daniel Chapter

One, 2010 FTC LEXIS 11, at *4-5 (Part IV) and are also appropriate in this case.

Parts V-IX of the Order, consistent with the proposed order, impose certain record-keeping, notification, and

reporting requirements, and properly serve to facilitate administration of the Order. Finally, part X of the Order,

consistent with the proposed order, provides for the termination of the Order in twenty (20) years. Respondents

assert that a twenty-year period is “unconscionable” given that a portion of the advertising at issue occurred,

and according to Respondents ceased, more than five years ago. However, as indicated in subsection 2.a., above,

numerous advertisements disseminated after 2006 were found to have made implied disease claims, without

adequate substantiation. F. 307-308, 321, 328, 344, 365, 432, 580-583, 962, 1143, 1313-1314. Accordingly, a

twenty-year duration is not unconscionable for the reason asserted by Respondents. See also Daniel Chapter One,

2010 FTC LEXIS 11, at *9-10 (Part XI) (providing for termination of order in twenty years).

5. Conclusion

The Order entered herewith will serve to prevent Respondents from engaging in deceptive advertising practices in

the future, is reasonably related to the unlawful acts or practices found to exist, and is sufficiently clear and precise.

IV. SUMMARY OF CONCLUSIONS OF LAW

1. Complaint Counsel bears the burden of proving jurisdiction and liability by a preponderance of evidence.
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2. Respondents POM Wonderful (“POM”) and Roll Global (“Roll”) are corporations within the meaning of

Sections 4 and 5 of the Federal Trade Commission Act (“FTC Act”).

3. Respondents Stewart Resnick (“Mr. Resnick”), Lynda Resnick (“Mrs. Resnick”) and Matthew Tupper (“Mr.

Tupper”), are “persons” within the meaning of Section 5 of the FTC Act.

4. Respondents' sales of POM Wonderful 100% pomegranate juice (“POM Juice”), and pomegranate extract

products known as POMx Pills and POMx Liquid (“POMx”) (collectively, the “POM Products”), are in or

affecting commerce, as required by the FTC Act, 15 U.S.C. § 45(a)(1).

*258 5. The Commission has jurisdiction over Respondents, and the conduct challenged in the Complaint, under

Sections 4 and 5 of the FTC Act. 15 U.S.C. § 44, 45.

6. Under the Commission's precedent regarding the statutory term “advertisement,” the media appearances

and interviews by Respondents, challenged in this case as advertisements, do not constitute “advertisements”

within the scope of the FTC Act because they were not paid for or sponsored by Respondents. 15 U.S.C. § 45,

52. Respondents do not dispute that the remaining advertisements and promotional materials disseminated by

Respondents and challenged in this case (the “Challenged Advertisements”) constitute “advertisements” within

the meaning of the FTC Act.

7. The POM Products constitute “food” or “drugs,” under Section 12 of the FTC Act. 15 U.S.C. § 55.

8. An advertisement is deceptive under the FTC Act if it is likely to mislead consumers, acting reasonably under the

circumstances, in a material respect. The determination of whether Respondents disseminated false advertisements

in violation of the FTC Act requires a three-part inquiry: (1) whether Respondents disseminated advertisements

conveying the claims alleged in the Complaint; (2) whether those claims were false or misleading; and (3) whether

those claims are material to prospective consumers.

9. An advertisement is deemed to convey a claim if a significant minority of reasonable consumers would interpret

the advertisement to contain that message. Whether an advertisement conveys a claim is a question of fact.

10. To determine whether an advertisement conveys an alleged claim, the first step is to examine the advertisement

itself (a “facial analysis”). A proper facial analysis requires an evaluation of such factors as the entire document,

the juxtaposition of various phrases in the document, the nature of the claim, and the nature of the transaction.

11. If, after viewing the advertisement as a whole, examining the interaction of all the different elements in the

advertisement, it can be concluded with confidence that an advertisement can reasonably be read to contain a

particular claim, a facial analysis is sufficient basis to conclude that the advertisement conveys the claim. However,

an implied claim must be reasonably clear or conspicuous from the face of the advertisement.

12. If, after a facial analysis, it cannot be concluded with confidence that a particular advertisement can reasonably

be read to contain a particular implied message, the advertisement will not be deemed to have made the alleged

claim unless extrinsic evidence allows the conclusion that such a reading of the advertisement is reasonable.

*259 13. “Target audiences,” for purposes of interpreting advertising, refer to special audiences who as a group

have a greater or lesser capability to recognize deceptive advertising than ordinary members of the adult population

or have a distinctive reaction to particular advertising claims. Complaint Counsel has failed to prove that its

asserted “target audience” of educated, affluent, health-conscious consumers would be more likely to interpret,
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or in fact did interpret, the Challenged Advertisements differently than ordinary consumers, or in what manner

that group would do so.

14. The evidence demonstrates that Respondents disseminated advertisements that a significant minority of

reasonable consumers would interpret to contain an implied claim that drinking eight ounces of POM Juice daily,

taking one POMx Pill daily, and/or taking one teaspoon of POMx Liquid daily, treats, prevents, or reduces the

risk of heart disease, prostate cancer and/or erectile dysfunction, and/or is clinically proven to do so, as alleged

in the Complaint. It is not necessary to demonstrate that every Challenged Advertisement conveyed one or more

of the alleged claims. Accordingly, even though the evidence failed to demonstrate that all of the Challenged

Advertisements made the alleged claims, Complaint Counsel met its burden of proving the first element of a false

advertising claim.

15. Two theories have been used to prove that an advertisement is deceptive or misleading: (1) the “falsity”

theory or (2) the “reasonable basis” theory. As to both the alleged “false establishment claims” and the alleged

“unsubstantiated efficacy claims,” proof of deception requires proof that Respondents' substantiation failed to

meet the level of substantiation required. Because whether Respondents' claims were deceptive turns on the nature

and quality of Respondents' substantiation, the falsity and reasonable basis theories collapse into the same inquiry:

did Respondents possess adequate substantiation to support their claims?

16. To determine whether the challenged claims are false or misleading, it must first be determined what level of

substantiation Respondents were required to have for their advertising claims. This determination is a question of

fact to be determined based upon the evidence adduced at trial. Next, it must be determined whether Respondents

possessed that level of substantiation. Respondents have the burden of establishing what substantiation they

relied on for their product claims. Complaint Counsel has the burden of proving that Respondents' purported

substantiation is inadequate.

17. Neither the FTC Act nor applicable case law requires well-designed, well-conducted, randomized, doubleblind, placebo-controlled human clinical trials (“RCTs”) to substantiate all health-related efficacy claims.

18. The evidence shows that the appropriate level of substantiation for the implied claims in this case that a

product can treat, prevent, or reduce the risk of a disease is competent and reliable scientific evidence. Where such

claims are made in connection with a food, or food-derived product, that is safe, and that is not being offered as

a substitute for medical treatment, well-designed, well-conducted, randomized, double-blind, placebo-controlled

human clinical trials, such as those required by the Food and Drug Administration are not required. However, for

claims that a food or food-derived product treats, prevents, or reduces the risk of a disease, experts in the field

would agree that competent and reliable scientific evidence must include clinical studies, although not necessarily

double-blind, randomized, placebo-controlled clinical trials, adequate to show that the product did treat, prevent,

or reduce the risk of disease.

*260 19. The weight of the persuasive expert testimony demonstrates that there was insufficient competent and

reliable scientific evidence to support the implied claims, made in advertisements disseminated by Respondents,

that the POM Products treat, prevent or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, or

are clinically proven to do so. Therefore, such claims were false or misleading within the meaning of Section 12

of the FTC Act, and Complaint Counsel met its burden of proving the second element of a false advertising claim.

20. An act or practice is material if it is likely to affect the consumer's conduct or decision with regard to a product

or service. Information is material if it is important to consumers.
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21. To be material, a claim does not have to be the only factor or the most important factor likely to affect a

consumer's purchase decision; it need only be an important factor.

22. The implied claims found to have been made in this case are material because they are health-related and

resulted in increased product sales for Respondents. In addition, consumer research of the attitudes and usage

habits of POM customers, conducted in the ordinary course of POM's business, shows that such claims are

material to consumers. Accordingly, Complaint Counsel has met its burden of proving the third element of a false

advertising claim.

23. Because Complaint Counsel has met its burden as to all three elements of a false advertising claim (see

Conclusion No. 8, above), liability has been established.

24. Having concluded that Respondents violated the FTC Act, that Act authorizes an order requiring Respondents

to cease and desist from such acts or practices.

25. Where one or more corporate entities operate in a common enterprise, each may be held liable for the deceptive

acts and practices of the others. POM and Roll are liable as a “common enterprise” and, accordingly, both are

held liable herein.

26. Injunctive relief may be obtained against an individual for a business entity's deceptive acts or practices if

the individual either participated directly in the business entity's deceptive acts or practices, or had the authority

to control them. The evidence demonstrates that Mr. Resnick, Mrs. Resnick, and Mr. Tupper each participated

directly in the business entity's deceptive acts or practices, and/or had the authority to control them, and, therefore,

each individual is held liable herein, along with POM and Roll.

27. Sole or ultimate control of a company is not necessary to establish individual liability. To establish liability

on the basis of authority to control, it is sufficient that Mr. Tupper was part of the inner circle that formulated,

controlled, and directed POM.

28. The purpose of a cease and desist order is to prohibit and prevent liable parties from engaging in deceptive

acts or practices in the future. The cease and desist order must be sufficiently clear that it is comprehensible to the

violator, and must be reasonably related to the violations found to exist.

*261 29. The Commission's authority includes power to issue cease and desist orders encompassing all products

or all products in a broad category, based on violations involving only a single product or group of products.

Coverage of all products in a broad category is a means of “fencing-in” one who has violated the statute.

30. In determining whether a fencing-in order bears a “reasonable relationship” to a violation of the FTC Act,

courts and the Commission consider: (1) the deliberateness and seriousness of the violation; (2) the degree of

transferability of the violation to other products; and (3) any history of prior violations. All three factors need not

be present for a reasonable relationship to exist. The more egregious the facts with respect to a particular factor,

the less important it is that another negative factor be present.

31. A violation of the FTC Act is considered transferable where other products could be sold utilizing similar

techniques. In the instant case, this transferability factor weighs strongly in favor of a multi-product order covering

any food, drug or dietary supplement, not just the POM Products. Respondents' advertising techniques could

readily be employed for any food, drug or dietary supplement.
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32. The seriousness of Respondents' violations is shown by the fact that the claims pertained to serious diseases

and dysfunction of the body, including cancer, and the inability of consumers to evaluate whether Respondents'

implied disease claims were true or actually supported by cited studies. The deliberateness of Respondents' conduct

is shown by the consistency of Respondents' advertising themes over the years and by the fact that Respondents'

advertising appeared in a wide variety of national and local media, for multiple years, which facts support the

conclusion that the advertisements found herein to have violated the FTC Act did not constitute accident or an

“isolated instance.”

33. Although Respondents have no prior violations, the strength of the other relevant fencing-in factors,

particularly transferability, is sufficient to establish a reasonable relation between the multi-product remedy and

Respondents' violations found in this case.

34. The provision in the Notice Order prohibiting Respondents from making any disease claims in the future,

unless such claim has been first approved by the Food and Drug Administration (“FDA”) (the “FDA pre-approval

requirement”) is rejected as unsupported by governing precedent and the facts of this case, and is not reasonably

related to the violations of the FTC Act found herein.

35. No previous decision by the Commission or any court has required FDA pre-approval as the required level of

substantiation for disease claims, including for purposes of a cease and desist order.

36. The required level of substantiation is a question of fact, and the evidence in this case demonstrates

that Respondents' implied disease claims require “competent and reliable scientific evidence,” which does not

necessarily require well-designed, well-conducted, randomized, double-blind, placebo-controlled human clinical

trials, such as those required by the FDA.

*262 37. The requirement in the order that respondents possess “competent and reliable scientific evidence” was

deemed sufficient to redress unsubstantiated disease claims in Daniel Chapter One, No. 9329, 2010 FTC LEXIS

11 (Jan. 25, 2010), review denied, Daniel Chapter One v. FTC, No. 10-1064, 2010 U.S. App. LEXIS 25496 (D.C.

Cir. Dec. 10, 2010), in which the violations were arguably more egregious than in the instant case.

38. The requirement in the Order in this case that Respondents possess competent and reliable evidence, as defined

in the Order, to substantiate their claims is consistent with established precedent, is reasonably related to the

violations found to exist in this case, is sufficiently clear and precise to guide Respondents' future advertising

practices, and is adequate to prohibit and prevent Respondents from engaging in the same or similar violations

in the future.

39. The Order attached herewith will serve to prohibit and prevent Respondents from engaging in deceptive

advertising practices in the future, is reasonably related to the unlawful acts or practices found to exist, and is

sufficiently clear and precise.

ORDER

DEFINITIONS

For purposes of this Order, the following definitions shall apply:

1. Unless otherwise specified, “individual respondents” shall mean Stewart A. Resnick, Lynda Rae Resnick, and

Matthew Tupper, individually and as officers of POM Wonderful LLC (“POM Wonderful”) and Roll Global

(“Roll”).
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2. Unless otherwise specified, “Respondents” shall mean POM Wonderful and Roll, their officers, agents,

successors and assigns; and the individual respondents and each of their successors, assigns, agents, and

representatives.

3. “Commerce” shall mean as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. § 44.

4. “Competent and reliable scientific evidence” shall mean tests, analyses, research, or studies, conducted and

evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the

profession to yield accurate and reliable results.

5. “Covered Product” shall mean any food, drug, or dietary supplement, including, but not limited to, the POM

Products.

6. “Food” and “drug” shall mean as defined in Section 15 of the Federal Trade Commission Act, 15 U.S.C. § 55.

7. “Endorsement” shall mean as defined in 16 C.F.R. § 255.0.

8. “POM Product” shall mean any food, drug, or dietary supplement containing pomegranate or its components,

including, but not limited to, POM Wonderful 100% Pomegranate Juice and pomegranate juice blends, POMx

Pills, POMx Liquid, POMx Tea, POMx Iced Coffee, POMx Bars, and POMx Shots.

*263 9. The term “including” in this Order shall mean “without limitation.”

10. The terms “and” and “or” in this Order shall be construed conjunctively or disjunctively as necessary, to make

the applicable phrase or sentence inclusive rather than exclusive.

I.

IT IS ORDERED that Respondents, directly or through any corporation, partnership, subsidiary, division, trade

name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale,

sale, or distribution of any Covered Product, in or affecting commerce, shall not make any representation in

any manner, expressly or by implication, including through the use of a product name, endorsement, depiction,

illustration, trademark, or trade name, that such product is effective in the diagnosis, cure, mitigation, treatment,

or prevention of any disease, including, but not limited to, any representation that the product will treat, prevent,

or reduce the risk of heart disease, including by decreasing arterial plaque, lowering blood pressure, or improving

blood flow to the heart; treat, prevent, or reduce the risk of prostate cancer, including by prolonging prostatespecific antigen doubling time (“PSADT”); or treat, prevent, or reduce the risk of erectile dysfunction; unless, at

the time it is made, the representation is non-misleading and, Respondents possessed and relied upon competent

and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted

in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific

evidence, to substantiate that the representation is true.

II.

IT IS FURTHER ORDERED that Respondents, directly or through any corporation, partnership, subsidiary,

division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion,

offering for sale, sale, or distribution of any Covered Product, in or affecting commerce, shall not misrepresent,
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in any manner, expressly or by implication, including through the use of a product name, endorsement, depiction,

or illustration, trademark, or trade name, the existence, contents, validity, results, conclusions, or interpretations

of any test, study, or research.

III.

IT IS FURTHER ORDERED that Respondents, directly or through any corporation, partnership, subsidiary,

division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion,

offering for sale, sale, or distribution of any Covered Product, in or affecting commerce, shall not make any

representation, in any manner, expressly or by implication, including through the use of a product name,

endorsement, depiction, illustration, trademark, or trade name, about the health benefits, performance, or

efficacy of any Covered Product, unless the representation is non-misleading, and, at the time of making such

representation, Respondents rely upon competent and reliable scientific evidence that is sufficient in quality and

quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the

entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.

IV.

*264 IT IS FURTHER ORDERED that:

A. Nothing in this Order shall prohibit Respondents from making any representation for any product that

is specifically permitted in labeling for such product by regulations promulgated by the Food and Drug

Administration pursuant to the Nutrition Labeling and Education Act of 1990; and

B. Nothing in this Order shall prohibit Respondents from making any representation for any drug that is permitted

in the labeling for such drug under any tentative final or final standard promulgated by the Food and Drug

Administration, or under any new drug application approved by the Food and Drug Administration.

V.

IT IS FURTHER ORDERED that POM Wonderful, Roll, and their successors and assigns, and individual

respondents shall, for five (5) years after the last date of dissemination of any representation covered by this Order,

maintain and upon request make available to the Commission for inspection and copying:

A. All advertisements, labeling, packaging, and promotional materials containing the representation;

B. All materials that were relied upon in disseminating the representation;

C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession or control that

contradict, qualify, or call into question the representation, or the basis relied upon for the representation,

including complaints and other communications with consumers or with governmental or consumer protection

organizations; and

D. All acknowledgments of receipt of this Order, obtained pursuant to Part VI.

VI.

IT IS FURTHER ORDERED that POM Wonderful, Roll, and their successors and assigns, and individual

respondents shall deliver a copy of this Order to all of their current and future principals, officers, directors,
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and managers, and to all of their current and future employees, agents, and representatives having managerial

responsibilities with respect to the subject matter of this Order, and shall secure from each such person a signed

and dated statement acknowledging receipt of the Order. POM Wonderful, Roll, and their successors and assigns,

and individual respondents shall deliver this Order to such current personnel within thirty (30) days after the

effective date of this Order, and to such future personnel within thirty (30) days after the person assumes such

position or responsibilities.

VII.

IT IS FURTHER ORDERED that POM Wonderful, Roll, and their successors and assigns, shall notify the

Commission at least thirty (30) days prior to any change in the corporations or any business entity that POM

Wonderful, Roll, and their successors and assigns, and individual respondents directly or indirectly control, or

have an ownership interest in, that may affect compliance obligations arising under this Order, including but

not limited to formation of a new business entity; a dissolution, assignment, sale, merger, or other action that

would result in the emergence of a successor entity; the creation or dissolution of a subsidiary, parent, or affiliate

that engages in any acts or practices subject to this Order; the proposed filing of a bankruptcy petition; or a

change in the business or corporate name or address. Provided, however, that, with respect to any proposed change

about which POM Wonderful, Roll, and their successors and assigns, and individual respondents learn less than

thirty (30) days prior to the date such action is to take place, POM Wonderful, Roll, and their successors and

assigns, and individual respondents shall notify the Commission as soon as is practicable after obtaining such

knowledge. Unless otherwise directed by a representative of the Commission, all notices required by this Part

shall be sent by overnight courier to the Associate Director for Enforcement, Bureau of Consumer Protection,

Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580, with the subject line FTC v.

POM Wonderful. Provided, however, that, in lieu of overnight courier, notices may be sent by first-class mail, but

only if electronic versions of such notices are contemporaneously sent to the Commission at DEbrief@ftc.gov.

VIII.

*265 IT IS FURTHER ORDERED that each individual respondent, for a period of ten (10) years after the

date of issuance of this Order, shall notify the Commission of the discontinuance of any current business or

employment, or of an affiliation with any new business or employment. The notice shall include the individual

respondent's new business address and telephone number and a description of the nature of the business or

employment and all duties and responsibilities. Unless otherwise directed by a representative of the Commission,

all notices required by this Part shall be sent by overnight courier to the Associate Director for Enforcement,

Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC

20580, with the subject line FTC v. POM Wonderful. Provided, however, that, in lieu of overnight courier, notices

may be sent by first-class mail, but only if electronic versions of such notices are contemporaneously sent to the

Commission at DEbrief@ftc.gov.

IX.

IT IS FURTHER ORDERED that POM Wonderful, Roll, and their successors and assigns, and individual

respondents within sixty (60) days after the effective date of this Order, shall each file with the Commission a true

and accurate report, in writing, setting forth in detail the manner and form of their compliance with this Order.

In addition, within ten (10) days of receipt of written notice from a representative of the Commission, they shall

submit additional true and accurate written reports.

X.
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This Order will terminate twenty (20) years from the date of its issuance, or twenty (20) years from the most

recent date that the United States or the Commission files a complaint (with or without an accompanying consent

decree) in federal court alleging any violation of the Order, whichever comes later; provided, however, that the

filing of such a complaint will not affect the duration of:

A. Any Part in this Order that terminates in less than twenty (20) years;

B. This Order's application to any proposed respondent that is not named as a defendant in such complaint; and

C. This Order, if such complaint is filed after the Order has terminated pursuant to this Part.

Provided, further, that if such complaint is dismissed or a federal court rules that Respondents did not violate

any provision of the Order, and the dismissal or ruling is either not appealed or upheld on appeal, then the Order

will terminate according to this Part as though the complaint had never been filed, except that the Order will not

terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or

ruling and the date such dismissal or ruling is upheld on appeal.

ORDERED:

D. Michael Chappell

Chief Administrative Law Judge

Date: May 17, 2012

APPENDIX TO INITIAL DECISION

FTC DOCKET 9344

TABULAR OR GRAPHIC MATERIAL SET FORTH AT THIS POINT IS NOT DISPLAYABLE

FTC

Footnotes

1 Although Commission Rule 3.41(b)(6) states that “[e]ach side shall be permitted to make a closing argument no later

than 5 days after the last filed proposed findings,” by Order dated January 26, 2012, good cause was found for moving

the closing arguments to March 6, 2012.

2 References to the record are abbreviated as follows:

CX — Complaint Counsel's Exhibit

PX — Respondents' Exhibit

JX — Joint Exhibit

Tr. — Transcript of testimony before the Administrative Law Judge

Dep. — Transcript of Deposition

CCB — Complaint Counsel's Post-Trial Brief

CCRB — Complaint Counsel's Post-Trial Reply Brief

CCFF — Complaint Counsel's Proposed Findings of Fact

CCRRFF — Complaint Counsel's Reply to Respondent's Proposed Findings of Fact

RB — Respondents' Post-Trial Brief

RRB — Respondents' Reply Brief
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RTB — Respondent Matthew Tupper's Post-Trial Brief

CCRRTB — Complaint Counsel's Reply to Respondent Matthew Tupper's Reply Brief

RFF — Respondents' Proposed Findings of Fact

RRCCFF — Respondents' Reply to Complaint Counsel's Proposed Findings of Fact

3 The following is an image of a caduceus symbol:

TABULAR OR GRAPHIC MATERIAL SET FORTH AT THIS POINT IS NOT DISPLAYABLE

4 As explained in Section III.C, infra, the four television interviews that Complaint Counsel challenges as

“advertisements” (see Complaint ¶ 9, I-J; CCB Appendix A) are not actionable as “advertisements” under the FTC

Act. See Section III.C.1. Thus, the interviews are hereinafter not included in the term, “Challenged Advertisements,”

and this Initial Decision does not include any findings regarding any claims allegedly made in those interviews.

5 Respondents also assert that an April 2009 discussion by Mrs. Resnick at USC's Annenberg School of Communication

with Dean Ernest J. Wilson III, on “How to Uncover the Hidden Gems in Your Business,” (CX0472 at 0002), does

not constitute “advertising.” RB at 92-95. Complaint Counsel responds that it does not challenge CX0472 at 0002

as deceptive under the FTC Act. CCRB at 43, n.41; CCRRFF ¶ 2546. Accordingly, an analysis of that exhibit is

not undertaken. Except as described in this section, Respondents do not dispute that the other advertisements and

promotional materials challenged in this case are “advertisements” for purposes of Sections 5 and 12 of the FTC Act.

6 In a case it brought against a telemarketer, the FTC, as prosecutor, acknowledged the distinction between “an

independent television program,” and an infomercial, which was a “paid advertisement.” FTC v. Direct Marketing

Concepts, Inc., 569 F. Supp. 2d 285, 304-05 (D. Mass. 2008).

7 Complaint Counsel's assertion that advertisements were distributed in the reception area of urologists' offices is not

supported by the evidence cited by Complaint Counsel. See CCFF 226.

8 The nature of the POM Products as food, or food-derived, is relevant to, and is considered in connection with, the

substantiation analysis in Section III.F.2, infra.

9 Respondents' contention that the evidence fails to show the date that certain advertisements were disseminated is moot,

to the extent that, with one exception, such advertisements are not among those found to have made the challenged

claims. See RFF 2252. As to that exception, CX0314, the evidence shows that this advertisement was disseminated

in 2008. F. 307. Respondents' further contention that some advertisements found herein to have made the challenged

claims are “outliers” that cannot support an injunctive order is addressed in Section III.H, infra, with respect to remedy.

Finally, Respondents assert that certain advertisements should be eliminated from consideration because of an alleged

admission by Complaint Counsel's rebuttal expert on marketing and market research, Dr. Michael Mazis, (F. 279-283)

that such advertisements were not being challenged. Having fully reviewed the testimony and Dr. Mazis' report in this

regard, that assertion is rejected as unsupported by the evidence.

10 The Aviram ACE/BP Study, conducted by Dr. Michael Aviram and his co-workers, was published as “Pomegranate

juice consumption inhibits serum angiotensin converting enzyme activity and reduces systolic blood pressure,” 158

Atherosclerosis 195-98 (2001). F. 774.

11 The Aviram CIMT/BP Study, conducted by Dr. Aviram and his co-workers, was published as, “Pomegranate juice

consumption for 3 years by patients with carotid artery stenosis reduces common carotid intima-media thickness

(CIMT), blood pressure and LDL oxidation” by Aviram M, Rosenblat M, Gaitini D, Nitecki S, Hoffman A, Dornfeld

L, Volkova N, Presser D, Attias J, Liker H, and Hayek T, (Clin Nutr. 2004; 23:423-33). F. 789.

12 The Ornish MP Study was conducted by Dr. Dean Ornish and colleagues and published as Sumner M, et al., Effects

of Pomegranate Juice Consumption on Myocardial Perfusion (MP) in Patients with Coronary Heart Disease, 96 Am.

J. Cardiology 810 (2005). F. 805. The Ornish MP Study was a randomized, placebo-controlled, double-blind study of

45 patients. F. 808. The Ornish MP Study indicated that there were no statistically significant differences between the

two groups in blood pressure. F. 813.

13 The Ornish CIMT Study was an unpublished, randomized, double-blind, placebo-controlled 73-person study that

measured carotid intima-media thickness (CIMT), blood pressure, and other related mechanisms for 12 months. F.

850. The Ornish CIMT Study indicated that there were no significant differences in the treatment group relative to

the placebo group, over time, for any of the other heart-related measurements, including systolic and diastolic blood

pressure. F. 859.

14 The Davidson BART/FMD Study, titled, The Effects of Pomegranate Juice on Flow-Mediated Vasodilation, is a

published study. F. 871. Brachial artery reactivity testing (“BART”) is a measurement of how much the brachial artery

dilates (enlarges) after a blood pressure cuff is inflated, and then released. F. 901. This is also called flow mediated
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dilation (“FMD”) testing. F. 901. The Davidson BART/FMD Study took measurements of blood pressure, although

blood pressure was not a primary or secondary endpoint of the study. F. 905. At the end of the Davidson BART/FMD

Study, there were no significant differences between treatment and placebo groups in blood pressure. F. 906.

15 The Davidson CIMT Study, was published as Davidson MH., et al., Effects of Consumption of Pomegranate Juice

on Carotid Intima-Media Thickness in Men and Women at Moderate Risk for Coronary Heart Disease, 104 Am. J.

Cardiology 936 (2009). F. 871. In the Davidson CIMT Study, exploratory endpoints included changes in blood pressure,

and the study indicated: “there were no differences between treatment groups for changes from baseline in traditional

cardiovascular risk markers, including ... blood pressures ....” F. 877, 878.

16 The San Diego Study was published as Heber D. et al., Safety and Antioxidant Activity of a Pomegranate EllagitanninEnriched Polyphenol Dietary Supplement in Overweight Individuals with Increased Waist Size, J. Agric Food Chem.,

Vol. 55, No. 24 (2007). F. 924. The San Diego Study measured blood pressure, but this was not a primary endpoint.

F. 927. The study indicated: “[t]here were no apparent treatment related changes in weight, systolic blood pressure,

diastolic blood pressure, pulse rate, respirations, or temperature.” F. 928.

17 The Ornish MP Study provides data on three imaging measures at baseline and three months for myocardial perfusion:

the summed rest score, or “SRS” (imaging results before the pharmacologic or exercise challenge), the summed stress

score, or “SSS” (imaging results after the pharmacologic or exercise challenge), and the summed difference score,

“SDS” (calculated by subtracting the SRS from the SSS). F. 810.

18 Atherosclerosis is a buildup of plaque in arteries. F. 988.

19 In addition, the Carducci Study showed no difference between a one pill dose and a three pill dose. Complaint Counsel's

expert, Dr. Stampfer, testified that the lack of a dose response, despite a three-fold difference in dosage, does not

support a causal relationship between POMx and change in PSADT. F. 1075.

20 The Forest/Padma-Nathan Study used a crossover design, and the 53 participants who completed the study received a

different beverage during the two 28-day treatment periods. Participants in cohort one consumed POM Juice in period

one and then switched to the placebo beverage in period two. Participants in cohort two consumed the placebo beverage

in period one and POM Juice in period two. F. 1211.

21 Mr. Tupper also relies on an initial decision in an FTC case from 1974, In re Auslander Decorator Furniture, Inc., 83

F.T.C. 1542, 1974 WL 175916 (April 23, 1974), in which the hearing examiner declined to find individual liability on

the part of two nominal officers because “the record [was] devoid of evidence of actual control or responsibility by

[the two individuals] ... over the affairs of ADF, and ... their participation in the unlawful acts and practices of ADF

was that of employees working under the direction and supervision of” the owner of the company. That case pre-dates

by many years the long line of federal appellate court cases, from Amy Travel to QT, cited above, which make clear

that participation is one of two grounds that justify individual liability. Auslander is contrary to such cases. Under

these circumstances, Auslander cannot reasonably be deemed controlling authority. In any event, unlike Auslander,

both participation and control have been demonstrated in this case, as more fully discussed below, and for that reason

as well, Auslander is not dispositive.

22 Mr. Tupper also argues that he was less involved in POM's advertising during the period 2003 to 2006, and for this

reason, he cannot be deemed to have “participated” in any deceptive advertisements from this period. RTB at 10.

However, the evidence shows that Mr. Tupper was, in fact, engaged in the medical research aspect of POM's business

from the time he first joined POM full time in 2003, although beginning in late 2006 or 2007, he became more engaged,

as the “connecting piece” between research and marketing. F. 37, 1411. In any event, as explained above in connection

with Respondents' “outlier” argument, even if advertisements from 2003 to 2006 are not considered, the violations

would be sufficient to justify a cease and desist order against Mr. Tupper. See Bristol-Meyers, 1983 FTC LEXIS 64,

at *250-51; Fedders Corp., 85 F.T.C. at 71-72. Thus, whether or not Mr. Tupper was less involved in these earlier

advertisements is not determinative as to whether a cease and desist order may issue against him.

23 Of course, Mr. Tupper's future employers would be bound, as would any business, to compliance with the FTC Act. As

noted above, the “competent and reliable evidence” substantiation standard for disease or efficacy claims only obliges

advertisers “to do that which the case law under Sections 5 and 12 of the FTC Act has defined as necessary to avoid

deception.” Daniel Chapter One, 2009 FTC LEXIS 259, at *70.

24 Complaint Counsel argues that deliberateness is also demonstrated by what Complaint Counsel asserts is evidence

that “[d]espite concerns expressed by the New York State Attorney General's Office, the Council for Better Business

Bureaus' National Advertising Division (“NAD”), NBC television, Dr. Pantuck, several IRBs [Institutional Review

Boards], the FTC, and the FDA that POM's advertising claims misled consumers, POM continued to make the same

or similar claims.” CCB 59-60. Complaint Counsel further contends that “Respondents' own internal assessments
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recognized that their research was not sufficient to substantiate POM's claims,” citing evidence regarding Respondents'

evaluation of their research in relation to FDA approval standards. CCB at 60. See, e.g., F. 1133 (internal document

stating, “it is unclear whether PSADT is acceptable as a registrational endpoint for a drug designed to prolong the

time to disease progression after initial therapy for prostate cancer”). Respondents strongly dispute the evidence upon

which Complaint Counsel relies to make these charges, and/or the inferences Complaint Counsel draws from the cited

evidence. RRB at 183-201. However, this Initial Decision need not, and does not, decide whether or not these additional

potential grounds for finding deliberateness have been demonstrated because the evidence already demonstrating

seriousness and deliberateness, and particularly transferability, more than adequately supports the multi-product Order

entered in this case. Moreover, whether or not Respondents knew their studies were inadequate to obtain FDA drug

approval for the POM Products, as Complaint Counsel contends, is not material since, as this Initial Decision has

determined, Respondents were not required to substantiate their claims with the type of clinical trials that might be

deemed necessary for drugs. E.g., F. 693, 694-710, 963, 1147-1148; Analysis Section III.F.2-5, supra.

25 Complaint Counsel's proposed order would apply the competent and reliable evidence standard, as set forth above,

to representations “about the health benefits, performance, or efficacy of any Covered Product” under part III. Thus,

Complaint Counsel acknowledges that this standard is sufficient for those claims, but nevertheless contends that FDA

pre-approval should be the required substantiation for disease claims.

26 Relying, inter alia, on Jacob Siegel Co. v. FTC, 327 U.S. 608 (1946), Complaint Counsel appears to argue that the

Commission is empowered to include virtually any provision in a cease and desist order, so long as it is “reasonably

related” to the violations in the case and is sufficiently clear and precise. CCB at 57-58. It is, of course, well

established that Congress, through the FTC Act, has granted the Commission “wide discretion in its choice of a remedy

deemed adequate to cope with ... unlawful practices” and that “the courts will not interfere except where the remedy

selected has no reasonable relation to the unlawful practices found to exist.” Jacob Siegel Co., 327 U.S. at 611-613.

However, this should not be seen as a directive that any and all “reasonably related” remedies are to be ordered. The

“reasonable relation” test is an outside limit on the permissible exercise of the FTC's discretion, rather than a standard

for determining what remedy will serve the purpose of prohibiting and preventing the recurrence of deceptive trade

practices. See In re Litton Indus., Inc., 1981 FTC LEXIS 94, at *147 (“The purpose of a cease and desist order is to

prevent the violations from being repeated, including by creating stringent monetary incentives (in the form of civil

penalties) for its observance.”).

27 Complaint Counsel also notes that the Commission has entered into consent orders with other respondents requiring

similar FDA pre-approval requirements. CCB at 64. Consent orders do not constitute legal precedent. “The

circumstances surrounding ... negotiated [consent decrees] are so different that they cannot be persuasively cited in

a litigation context.” United States v. E. I. du Pont de Nemours & Co., 366 U.S. 316, 331 n.12 (1961). Rather, as

confirmed by the express terms of the consent orders cited by Complaint Counsel, a consent order “is for settlement

purposes only and does not constitute an admission by the respondent that the law has been violated.” In re Dannon Co.,

151 F.T.C. 62, 91 (2011); In re Nestle Healthcare Nutrition, Inc., 151 F.T.C. 1, 10 (2011); see also In re Iovate Health

Sciences U.S.A., Inc., No. 10-CV-587 (W.D.N.Y. July 29, 2010) (stating that Commission and Defendants “stipulate

and agree to entry of this Order” but “do not admit or deny any of the allegations ....”) (available at http:// www.ftc.gov/

os/caselist/0723187/100729iovatestip.pdf).

28 In support of its argument that FDA drug approval standards are “similar” to FTC requirements, Complaint Counsel

cites to the portion of the Daniel Chapter One Initial Decision that found as a fact, based on the weight of the

expert testimony presented in that case, that “competent and reliable scientific evidence” to support the respondents'

cancer effectiveness claims required “well-designed, controlled, clinical trials ....” 2009 FTC LEXIS 157, at *109-11.

Consistent with that evidence, the order in Daniel Chapter One, like the Order in this case, defined competent and

reliable scientific evidence as “tests, analyses, research, [or] studies, ... conducted and evaluated in an objective manner

by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable

results.” Thus, Daniel Chapter One is not authority for requiring Respondents in this case to substantiate claims in

accordance with FDA approval standards.

29 However, were Respondents to advertise a “drug” in the future, Thompson Medical clearly shows how application of

the competent and reliable scientific evidence standard, as defined in the Order, could well result in a required level of

substantiation that is consistent with FDA standards for drug approval.

30 It must also be noted that there is no evidence in the record of any coordination with, or acceptance by, the FDA with

respect to requiring the FDA to pre-approve advertising claims challenged under the FTC Act.
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31 Rule 2.41 states in pertinent part: “(d) Any respondent subject to a Commission order may request advice from the

Commission as to whether a proposed course of action, if pursued by it, will constitute compliance with such order.

The request for advice should be submitted in writing to the Secretary of the Commission and should include full and

complete information regarding the proposed course of action. On the basis of the facts submitted, as well as other

information available to the Commission, the Commission will inform the respondent whether or not the proposed

course of action, if pursued, would constitute compliance with its order.” 16 C.F.R. § 2.41(d).

32 Because Complaint Counsel has failed to adequately justify departing from established precedent to provide for the

proposed FDA pre-approval requirement, that requirement is not included in the Order. Thus, this Initial Decision need

not, and does not, address whether or not the proposed FDA pre-approval requirement should also be rejected because it

exceeds the Commission's authority under the FTC Act and/or violates Respondents' First Amendment rights. It should

be noted, however, that Respondents' generalized assertion that none of its commercial speech should be “barred” is

without merit. RRB at 177. Requiring adequate substantiation for advertising claims does not “bar” commercial speech,

but serves to prevent dissemination of misleading claims. E.g., Bristol-Meyers, 738 F.2d at 562 (“Even in the absence

of a finding of actual deception, agencies may properly regulate speech that is merely potentially deceptive.”); Sears,

Roebuck, 676 F.2d at 399 (“[T]he Commission may require prior reasonable substantiation of product performance

claims after finding violations of the Act, without offending the [F]irst [A]mendment.”); Jay Norris, Inc. v. FTC,

598 F.2d 1244, 1252 (2d Cir. 1979) (“[B]ecause the FTC here imposes the requirement of prior substantiation as a

reasonable remedy for past violations of the Act, there is no unconstitutional prior restraint of petitioners' protected

speech.”). See also Zauderer v. Office of Disciplinary Council, 471 U.S. 626, 638 (1985) (holding that “[t]he States

and the Federal Government are free to prevent the dissemination of commercial speech that is false, deceptive, or

misleading”); In re R. M. J., 455 U.S. 191, 207 (1982) (stating that “the States retain the authority to regulate advertising

that is inherently misleading or that has proved to be misleading in practice”).

2012 WL 2340406 (F.T.C.)

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In the Matter of R.J. REYNOLDS TOBACCO COMPANY,..., 1988 WL 490114 (1988)

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1988 WL 490114 (F.T.C.)

FEDERAL TRADE COMMISSION (F.T.C.)

In the Matter of

R.J. REYNOLDS TOBACCO COMPANY, INC., a corporation.

Docket No. 9206

ISSUED: March 4, 1988

*1 COMMISSIONERS:

Daniel Oliver, Chairman

Patricia P. Bailey

Terry Calvani

Mary L. Azcuenaga

Andrew J. Strenio, Jr.

ORDER

This matter has been heard by the Commission upon the appeal of counsel supporting the complaint from the

initial decision, and upon briefs and oral argument in support of and in opposition to the appeal. For the reasons

stated in the accompanying opinion, the Commission has determined to reverse the initial decision and remand

the matter for further proceedings. Therefore,

IT IS ORDERED that the initial decision of the Administrative Law Judge is reversed and the matter remanded

for further proceedings in accordance with this order and accompanying opinion.

By the Commission, Chairman Oliver dissenting.

Benjamin I. Berman

Acting Secretary

OPINION OF THE COMMISSION

By Strenio, Commissioner.

The issue presented here is whether the Administrative Law Judge (“ALJ”) erred when he granted respondent

R.J. Reynolds Tobacco Company, Inc.'s (“Reynolds”) motion to dismiss on the ground that “Of Cigarettes and

Science” was not commercial speech and, thus, not subject to the Commission's jurisdiction. We find that the

ALJ erred when he granted the motion to dismiss. We also find that the ALJ erred when he ruled that further

opportunity to discover and present facts relating to jurisdiction was not permitted. His order is reversed and the

matter remanded for further proceedings consistent with this opinion.
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I. Procedural History.

This case involves an advertisement, entitled “Of Cigarettes and Science,” allegedly disseminated by Reynolds

in the course of its business of manufacturing, advertising and selling cigarettes. Complaint, ¶ ¶ 2-4. The

advertisement discusses, among other things, the procedures that scientists use to test scientific hypotheses and

sets forth information about a scientific study known as the Multiple Risk Factor Intervention Trial (“MR FIT”).

Complaint, Attachment A.

On June 16, 1986, the Federal Trade Commission (“Commission” or “FTC”) issued a complaint alleging that

the Reynolds advertisement falsely and misleadingly represents: that the purpose of the MR FIT study was to

determine whether heart disease is caused by cigarette smoking; that the MR FIT study provides credible scientific

evidence that smoking is not as hazardous as the public or the reader has been led to believe; and that the MR FIT

study tends to refute the theory that smoking causes coronary heart disease. Complaint, ¶ ¶ 5-6. In addition, the

complaint alleges that the advertisement fails to disclose certain material facts about the MR FIT study. Complaint,

¶ 7.

Respondent filed a motion to dismiss the complaint on June 26, 1986. The motion sought dismissal on the ground

that the Commission had no subject matter jurisdiction over the “Of Cigarettes and Science” advertisement because

“the acts and practices complained of are expressions of opinion on issues of social and political importance which

cannot be regulated by the Federal Trade Commission consistent with the First Amendment.” 1 Motion to Dismiss,

¶ 1. According to Reynolds, the ALJ was required to determine the jurisdictional issue on the basis of the pleadings

alone; consideration of extrinsic evidence was both irrelevant and itself violative of the First Amendment. 2

*2 Complaint counsel opposed the motion to dismiss, arguing alternatively that the motion should be denied

because the challenged advertisement was properly classified as commercial speech and, thus, properly subject

to the Commission's jurisdiction or because the motion raised issues that required further factual development. 3

After hearing argument on the motion, the ALJ concluded that the advertisement was not commercial speech but

rather speech fully protected by the First Amendment. The ALJ thus ruled that the advertisement was outside the

jurisdiction of the Commission. Order, dated August 4, 1986. In his decision, the ALJ rejected the argument that

complaint counsel should be granted further opportunity to discover and present facts relating to jurisdiction. Id.

at 14-15. He concluded that further discovery was “contrary to law and unacceptable” because categorization of

speech as either commercial or noncommercial has been “customarily resolved by the courts on the basis of what is

contained in the ads” and, in any event, he had already granted complaint counsel “ample time” for discovery. Id.

Counsel supporting the complaint appealed the ALJ's initial decision to the Commission.

II. FTC Jurisdiction.

We agree with the parties and the ALJ that unless the Reynolds advertisement can be classified as commercial

speech, it is not subject to the Commission's jurisdiction. Thus, consideration of whether the ALJ erred when

he concluded, at this stage of the proceeding, that the complaint should be dismissed necessarily begins with an

analysis of the legal standards applicable to classification of speech as commercial or noncommercial.

Following that analysis, the facts of this case will be applied to the legal framework. When making this analysis,

the procedural standards applicable to motions to dismiss apply. Under those standards, the complaint must allege

facts sufficient to confer jurisdiction. For purposes of this analysis, all of the factual allegations of the complaint

concerning jurisdiction are presumed true. See, e.g., Scheuer v. Rhodes, 416 U.S. 232, 236 (1974). See also 2A
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J. Moore, J. Lucas & G. Grotheer, Moore's Federal Practice, ¶ 12.07 [2.-1] at 12-46 to 12-47 (2d ed. 1987). If the

complaint does not allege sufficient facts to confer jurisdiction, it must be dismissed.

If, on the other hand, the complaint does allege facts which if true would be sufficient to establish jurisdiction,

then another inquiry is required. Specifically, the question then becomes whether the facts alleged are supported

by the evidence. In making this determination, there is no presumption that the allegations are true, and the burden

is on complaint counsel to prove jurisdiction by a preponderance of the evidence. See, e.g., Menchaca v. Chrysler

Credit Corp., 613 F.2d 507, 511 (5th Cir.), cert. denied, 449 U.S. 953 (1980); Mortensen v. First Federal Savings

& Loan Ass'n, 549 F.2d 884 (3d Cir.1977).

*3 Finally, we also address whether, and to what extent, consideration of extrinsic evidence is permitted to

resolve the jurisdictional issue.

A. The First Amendment Guarantee of Freedom of Speech.

The protections afforded by the First Amendment guarantee against laws “abridging the freedom of speech” are of

fundamental importance to a democratic society. Justice Cardozo once characterized the First Amendment as “the

matrix, the indispensible condition of nearly every other form of freedom.” 4 The reach of the First Amendment

extends to individuals as well as to corporations and other entities. First National Bank of Boston v. Bellotti, 435

U.S. 765 (1978).

The Constitution, however, accords different degrees of protection based upon the type of speech at issue. The

core examples of speech entitled to the highest level of protection are political discourse and expressions about

philosophical, religious, artistic, literary or ethical matters. In light of its high societal value, regulation of such

“fully protected” speech generally is limited to reasonable time, place and manner restrictions.

Commercial speech, by contrast, is accorded less constitutional protection, but protection that is “nonetheless

substantial.” Bolger v. Youngs Drug Products Corp., 463 U.S. 60, 68 (1983).

5

 Unlike fully protected speech,

commercial speech can be regulated on the basis of its content.

The more limited protection accorded commercial speech permits the FTC to act when necessary to challenge

false or deceptive advertising. 6 See, e.g., Thompson Medical Co. v. FTC, 791 F.2d 189 (D.C.Cir.1986), cert.

denied, 107 S.Ct. 1289 (19 87); Sears, Roebuck & Co. v. FTC, 676 F.2d 385 (9th Ci r.1982); Warner-Lambert Co.

v. FTC, 562 F.2d 749 (D. C.Cir.1977), cert. denied, 435 U.S. 950 (1978); Beneficial Corp. v. FTC, 542 F.2d 611

(3d Cir.1976), cert. denied, 430 U.S. 983 (1977). Commission action to prevent false or deceptive advertising, in

turn, serves the important public interest in informed commercial decision-making.

B. Commercial Speech.

The Supreme Court has referred to the “core notion” of commercial speech as speech proposing a commercial

transaction. Bolger v. Youngs Drug Products, 463 U.S. at 66 (citing Virginia State Board of Pharmacy v. Virginia

Citizens Consumer Council, Inc., 425 U.S. 748, 762 (1976) and Pittsburgh Press Co. v. Pittsburgh Comm'n on

Human Relations, 413 U.S. 376, 385 (1973)). See also Central Hudson Gas & Electric Corp. v. Public Service

Comm'n, 447 U.S. 557, 562 (1980); Linmark Associates, Inc. v. Township of Willingboro, 431 U.S. 85 (1977).

In Central Hudson, the Court also discussed commercial speech as speech solely related to the economic interests

of both the speaker and the speaker's audience. 447 U.S. at 561.

The Court also has made it clear that commercial speech may include speech that links a product to important

public issues or matters subject to current public debate. Central Hudson, 447 U.S. at 562 n. 5; Bolger v. Youngs
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Drug Products Corp., 463 U.S. at 67-68; Zauderer v. Office of Disciplinary Counsel of the Supreme Court of

Ohio, 471 U.S. 626, 637 n. 7 (1985). Indeed, in Central Hudson, the Court majority found that the New York

State Public Service Commission order banning all advertising intended to promote the sale of utility services or

electricity involved “only commercial speech.” 447 U.S. at 561. The majority expressly rejected Justice Stevens'

suggestion that the category “promotional advertising” would also include fully protected speech if, for example,

the speech touted the environmental benefits of electricity, noting:

*4 [Justice Stevens' approach] would grant broad constitutional protection to any advertising that links a product

to a current public debate. But many, if not most, products may be tied to public concerns with the environment,

energy, economic policy, or individual health and safety.

Id. at 562 n. 5. The Court observed that companies have full constitutional protection for their direct comments

on public issues and thus, there did not appear to be a need for similar protection “when such statements are

made only in the context of commercial transactions. In that context, the State retains the power to ‘ensur[e]

that the stream of commercial information flow[s] cleanly as well as freely.’ ” Id. (citing Virginia State Board

of Pharmacy, 425 U.S. at 772).

The Supreme Court has not established a bright line test for ascertaining the boundary between commercial speech

that may also include information about matters of important public interest and speech that constitutes direct

comments on public issues. Indeed, the Court has noted the complexities of delineating the boundary. See Zauderer

v. Office of Disciplinary Counsel, 471 U.S. at 637 (the “precise bounds” of commercial speech are “subject to

doubt”); In re Primus, 436 U.S. 412, 438 n. 32 (1978) (line between commercial and noncommercial speech “will

not always be easy to draw”). Moreover, the Court has recognized that “the diverse motives, means, and messages

of advertising may make speech ‘commercial’ in widely varying degrees.” Bigelow v. Virginia, 421 U.S. 809,

826 (1975).

The Court, however, has offered guidance for determining what constitutes commercial speech by mentioning

a number of characteristics of commercial speech. The Commission considers it premature, particularly in the

absence of a full record, to say which characteristics will be determinative in deciding whether the Reynolds

advertisement constitutes commercial speech. It is appropriate, however, to start with those characteristics that

the Court has considered in its relatively few commercial speech decisions. 7

We begin with the content of the speech in question. See Bates v. State Bar of Arizona, 433 U.S. 350, 363 (1977).

The Court in Central Hudson identified speech containing a message promoting the demand for a product or

service as speech that can be classified as commercial. See 447 U.S. at 559-62.

In addition, commercial speech typically refers to a specific product or service. Bolger v. Youngs Drug Products,

463 U.S. at 66. In many cases, the product reference includes the brand name of a product offered for sale.

However, the Bolger Court stated that a generic reference to a product would not necessarily remove it from the

category of commercial speech: “For example, a company with sufficient control of the market for a product

may be able to promote the product without reference to its own brand name. Or, a trade association may make

statements about a product, without reference to specific brand names.” 463 U.S. at 66-67 n. 13 (citing with

approval National Commission on Egg Nutrition v. FTC, 570 F.2d 157 (7th Cir .1977), cert. denied, 439 U.S.

821 (1978)). 8

*5 In Friedman v. Rogers, 440 U.S. 1, 11 (1979), the Court noted that information about attributes of a product

or service offered for sale, such as type, price, or quality, is also indicative of commercial speech. 9 Likewise,

the Court has indicated that information about health effects associated with the use of a product can properly be

classified as commercial speech. 10 See Bolger v. Youngs Drug Products, 463 U.S. at 66-67 (claims discussing
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the benefits of condoms for the prevention of venereal disease). See also National Commission on Egg Nutrition,

570 F.2d at 163 (deceptive claims to the effect that no scientific evidence supported the claim that eating eggs

increases the risk of heart disease).

In addition to content, the Court has found that the means used to publish speech is relevant to the classification

issue. For example, the Court has recognized that commercial speech frequently takes the form of paid-for

advertising. See Bolger v. Youngs Drug Products, 463 U.S. at 66 (citing New York Times Co. v. Sullivan, 376

U.S. 254, 265-66 (1964)). See also Bates v. State Bar of Arizona, 433 U.S. at 363-64; Virginia State Board of

Pharmacy, 425 U.S. at 761.

The Court also has indicated that the speaker's economic or commercial motivation is germane to the issue of

whether speech is commercial. In re Primus, 436 U.S. at 438 n. 32 (line between commercial and noncommercial

speech is “based in part on the motive of the speaker”); Bolger v. Youngs Drug Products, 463 U.S. at 67. See also

National Commission on Egg Nutrition, where the Seventh Circuit held that commercial speech should not “be

narrowly limited to the mere proposal of a particular commercial transaction but [should] extend to false claims

as to the harmlessness of the advertiser's product asserted for the purpose of persuading members of the reading

public to buy the product.” 570 F.2d at 163.

It would appear for purposes of this analysis that an important consideration will be whether the speech is

promotional in nature. Does the speech benefit or seek to benefit the economic interests of the speaker by

promoting sales of its products? And, does the speech affect or seek to affect purchasing decisions by the receivers

of the information?

This type of speech can be contrasted with speech that does not benefit the economic interests of the speaker by

influencing the reader or listener in the role of consumer, but instead provides, for example, information relevant

to individual political decisions, or to artistic or cultural choices. Such speech may not further the informational

function of commercial decision-making. See, e.g., Consolidated Edison Co. of N.Y., Inc . v. Public Service

Comm'n, 447 U.S. 530 (1980) (billing insert was not addressed to informed decision-making about the purchase

of a specific product, i.e., nuclear-generated electricity, but concerned the human and environmental risks that

could result from a malfunction or accident at a nuclear power plant); First National Bank of Boston v. Bellotti,

435 U.S. 765 (1978) (speech in question was limited to expression directed to the reader or listener as a voter). 11

*6 Although it may be difficult in some cases, the Commission thinks that it is possible to determine whether a

specific advertisement that includes information connected to public issues nonetheless addresses the concerns of

a purchaser of the advertiser's product or service. To conclude otherwise would allow sellers of certain products

to avoid the proscription against false and misleading advertising merely by linking their product to a public issue.

Indeed, in National Commission on Egg Nutrition, the product eggs was inextricably linked to the cholesteroland-heart-disease issue. Despite the connection, the Seventh Circuit ruled that the advertisements, including

“Cholesterol and the Egg: A Mystery,” were commercial speech.

C. The ALJ's Decision to Grant Respondent's Motion.

The question remains, of course, whether the ALJ erred when he granted respondent's motion to dismiss. In

reaching his decision, the ALJ was required to consider the various “messages, means, and motives” of the

advertisement (see Bigelow, 421 U.S. at 826), including the presence or absence of the characteristics identified

by the case law as relevant to whether speech is commercial.

Accepting the allegations of the complaint concerning jurisdiction as true for purposes of this appeal, 12 the content

of the Reynolds advertisement includes words and messages that are characteristic of commercial speech. The
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advertisement refers to a specific product, cigarettes. Complaint, ¶ ¶ 2, 4; Bolger v. Youngs Drug Products, 463

U.S. at 66. Moreover, the advertisement discusses an important product attribute the alleged connection between

smoking and heart disease. Complaint, ¶ ¶ 4, 5; Friedman v. Rogers, 444 U.S. at 11; National Commission on Egg

Nutrition, 570 F.2d at 1 63. A message that addresses health concerns that may be faced by purchasers or potential

purchasers of the speaker's product may constitute commercial speech. See Bolger v. Youngs Drug Products, 463

U.S. at 66-67; National Commission on Egg Nutrition, 570 F.2d at 163.

Similarly, the complaint alleges that “Of Cigarettes and Science” is an advertisement (Complaint, ¶ 2), which

we understand to mean a notice or announcement that is publicly published or broadcast and is paid-for. Thus,

viewed in light of the allegations of the complaint, the “means” used to disseminate the Reynolds advertisement

paid-for advertising is typical of commercial speech. Bolger v. Youngs Drug Products, 463 U.S. at 66; Virginia

State Board of Pharmacy, 425 U.S. at 761.

Finally, the complaint alleges that respondent is in the business of selling cigarettes. Complaint, ¶ 4. It is reasonable

to infer that Reynolds, as a seller of cigarettes, had a direct, sales-related motive for disseminating the “Of

Cigarettes and Science” advertisement. As discussed above, economic motivation also may be indicative of

commercial speech. In re Primus, 436 U.S. at 438 n. 32; Bolger v. Youngs Drug Products, 463 U.S. at 67; National

Commission on Egg Nutrition, 570 F.2d at 163.

*7 Thus, viewed in light of the allegations contained in the complaint, we conclude that the ALJ erred when he

granted respondent's motion to dismiss at this stage of the proceeding.

It should be clear, however, that the Commission makes no final determination of jurisdiction. As we noted above,

supra at 4-5, any such conclusion requires proof that the complaint allegations concerning jurisdiction are true.

Inasmuch as respondent has not answered the complaint, the record does not indicate what factual allegations

concerning jurisdiction, if any, are controverted. Thus, final findings of fact with respect to jurisdiction at this

stage of the proceeding would be premature.

Instead, we think it is appropriate to remand the matter to the ALJ for the purpose of determining whether

application of the facts to the appropriate legal standards supports a finding of jurisdiction. Upon remand, the

ALJ may weigh the evidence and resolve any factual disputes. If the ALJ determines that additional evidence is

needed to make a final determination on jurisdiction, 13 he shall permit further opportunity to develop and present

evidence on the issue. See Part II.D, infra at 1 7-22. We emphasize, however, that we have not concluded that

presentation of extrinsic evidence is necessarily required for determining whether the Reynolds advertisement is

commercial speech. The decision of what evidence to present in order to attempt to meet their burden of proving

jurisdiction is a decision to be made properly by counsel supporting the complaint.

D. Consideration of Extrinsic Evidence.

Another issue that arose below is whether, and to what extent, consideration of extrinsic evidence is permitted

to resolve the jurisdictional issue. As a general matter, a party may establish the existence of subject matter

jurisdiction through the use of extrinsic evidence. 14 Respondent, however, contends that reliance upon extrinsic

evidence is irrelevant and itself violative of the First Amendment.

We agree that consideration of extrinsic evidence is permitted only if the evidence is relevant to the issues

presented and is not barred by any evidentiary privilege. 15 Nonetheless, we disagree with respondent's sweeping

assertion that this standard prohibits any and all consideration of extrinsic evidence in determining whether

the Reynolds advertisement is subject to the Commission's jurisdiction. We are aware of no decision holding
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that consideration of extrinsic evidence is impermissible in determining whether an advertisement constitutes

commercial speech.

Indeed, the Supreme Court in In re Primus, 436 U.S. 412 (1978), clearly relied upon extrinsic evidence for its

finding that application by the Supreme Court of South Carolina of its Disciplinary Rules to appellant's solicitation

by letter on the American Civil Liberties Union's (“ACLU”) behalf violated the First Amendment. In addition to

considering the solicitation letter, the Court looked to evidence relating to the circumstances that led to appellant's

letter and the events that took place after the letter was sent, the aims and practices of the ACLU, and the appellant's

lack of any economic motivation a characteristic which the Court noted distinguished the appellant's solicitation

from the purely commercial solicitation present in Ohralik v. Ohio State Bar Ass'n, 436 U.S. 447 (1978), decided

the same day.

*8 Moreover, in Herbert v. Lando, 441 U.S. 153, 175 (1979), the Supreme Court held that the First Amendment

did not bar a plaintiff in a defamation action from inquiring into the editorial processes of the respondent members

of the press because the information sought to be discovered was directly relevant to proof of a critical element

of the plaintiff's cause of action. 16 Instead, the Court found that the relevancy requirement of Rule 26(b)(1) was

sufficient protection against improper forays into the respondents' thought processes. We find the reasoning in

Herbert v. Lando applicable here. 17 Thus, we find no basis for concluding that discovery and presentation of

relevant and non-privileged evidence concerning jurisdiction must be categorically barred.

Evidence that may be relevant to deciding whether the Reynolds advertisement is commercial speech includes

facts concerning the publication or dissemination of the advertisement, such as whether it was paid-for, where

and in which publications it was disseminated, whether it was placed in editorial space (such as an opened page)

or advertising space in the publication, whether it was prepared as a letter to the editor, whether it was sent to

representatives of the media for selection on merit by editorial boards, and to whom it was disseminated outside

the media.

Evidence about the promotional nature of the advertisement also may be relevant. Therefore, it might be useful

to consider the circumstances surrounding the development of the advertisement, such as whether it was targeted

to consumers or legislators; whether it was intended to affect demand for Reynolds' cigarettes or brands or to

affect particular legislative or regulatory proposals; whether the advertisement was subjected to copy testing or

to review by focus groups and, if so, the nature of the questions used in the copy tests or focus group sessions;

and the results of those procedures both in terms of what they showed and what changes, if any, Reynolds made

in response to those showings. Evidence relating to the message(s) Reynolds itself intended to convey through

the advertisement also may be relevant. In addition, Reynolds' share of the cigarette market may be relevant to

deciding whether including a brand name reference is a prerequisite to a determination that the advertisement

constitutes commercial speech. 18

Of course, to the extent that any specific facts are protected by an evidentiary privilege, their use would not be

permitted even if relevant. Determination of whether or not evidence is privileged, however, should be made on

an individual basis. In this connection, we disagree with respondent's contention that use of all evidence other

than the “Of Cigarettes and Science” advertisement would violate the First Amendment. See Herbert v. Lando,

441 U.S. at 175.

In sum, other than the relevancy and privilege requirements, we find no categorical evidentiary bar against

discovery or presentation of extrinsic evidence that might assist in determining on the record whether the

Reynolds advertisement constitutes commercial speech, and consequently, would be subject to the Commission's

jurisdiction.
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*9 III. Conclusion.

For the reasons discussed above, we reverse the Administrative Law Judge's order granting respondent's motion

to dismiss for lack of subject matter jurisdiction, and remand for further proceedings consistent with this opinion.

*10 SEPARATE STATEMENT OF CHAIRMAN OLIVER, DISSENTING

I. INTRODUCTION

The First Amendment prohibits the federal government from acting as umpire in the contest of ideas. The

government cannot select which issues are worth debating nor selectively exclude certain participants from that

debate. Under the First Amendment, individuals and corporations alike have a fully protected right to engage in

direct comment on public issues free from governmental regulation or censorship.

First Amendment protection of public debate generally coexists very peacefully with the Federal Trade

Commission's exercise of its authority to ban deceptive commercial speech. While the First Amendment protects

unfair and false statements in the public marketplace of ideas, it does not protect such statements in the commercial

marketplace for goods and services. The Commission's jurisdictional authority extends to the hawking of wares,

not the hawking of ideas.

The American marketplace for ideas is decentralized and occurs in numerous arenas: in Congress, in academia,

in books and pamphlets, in newspapers, over the airways, over backyard fences, at the workplace, door-to-door.

Seldom does the government step in to crown a victor or promulgate an official version of the truth. In the debate

over public policies regarding smoking, however, the government has not only based its policies on an official

version of the truth, it has compelled private citizens to propagandize in favor of that version of the truth. 1 In this

case, the Federal Trade Commission is attempting to go one step further and regulate a challenge to the official

orthodoxy.

At issue in this case is whether R.J. Reynolds Tobacco Co. (RJR) has a fully protected right under the First

Amendment to question the officially accepted view regarding the link between cigarette smoking and heart

disease. In March 1985, RJR paid various newspapers and magazines to publish a communication captioned

“Of Cigarettes and Science,” in which RJR questioned the objectivity of the scientists who examine the issue

of smoking and health. 2 Relying on data from a governmentally funded study, RJR argued that there is still a

scientific question about the link between cigarettes and heart disease.

The Federal Trade Commission responded by issuing a complaint that alleges that the RJR communication is

deceptive. RJR has in turn challenged the subject matter jurisdiction of the FTC, arguing that the publication at

issue is fully protected under the First Amendment. The Administrative Law Judge ruled that RJR is correct, that

the publication is an editorial rather than commercial speech, and dismissed the complaint for lack of subject

matter jurisdiction.

In my opinion, RJR and the Administrative Law Judge are clearly correct. The RJR publication is, without

doubt, a direct comment on a matter of public concern the link between cigarette smoking and heart disease.

Any commercial effect of the RJR communication is inextricably intertwined with RJR's participation in the

contest of ideas. Accordingly, the RJR publication is fully protected by the First Amendment, even if one of the

consequences of the publication is to affect cigarette consumption. R.J. Reynolds cannot be disqualified from

questioning scientific certitude merely because its potential success in persuading the general public that the

question remains open could also have an effect on sales of its product.
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*11 The Commission majority attempts to finesse the issue of whether the RJR communication is commercial

speech (which the Commission has subject matter jurisdiction over) or fully protected speech (thus requiring

dismissal). The Administrative Law Judge is reversed, and the case remanded, but the reasons for doing so

are not immediately apparent. Although finding that the words and message of the RJR communication are

characteristic of commercial speech, the Commission majority purportedly declines to decide whether the

communication is commercial speech. Further, without ruling that additional extrinsic evidence is needed to decide

the key jurisdictional issue, 3 the majority nonetheless sets forth the facts it believes may be relevant. On closer

examination, it becomes apparent that the majority makes determinations that logically compel it to conclude

that the piece is commercial speech, but seeks to duck the issue, sending the matter back to the ALJ for further

discovery that might bolster a finding that the Commission has subject matter jurisdiction.

In my considered opinion there is no reason why the Commission cannot make an explicit determination today.

The text and the context of RJR's communication are before the Commission. From the face of the document itself

we can determine that the communication is a direct comment on a matter of public debate. The piece is not a

solicitation for a commercial transaction with a gratuitous reference to a public debate thrown in to evade laws

relevant to commercial advertising. RJR's direct comment on a matter of public debate is inextricably intertwined

with any commercial effect that may result from RJR's participation in that debate. As Supreme Court precedent

establishes, direct comment on a matter of public debate is fully protected under the First Amendment, even if it

has a commercial effect, unless the comment on the public issue is merely gratuitously linked with a commercial

message. No discovery is needed or justified prior to a ruling on the Commission's subject matter jurisdiction. The

factual inquiry that the majority proposes would either produce unnecessary background information or engage

the Commission in an irrelevant quest to establish RJR's “intent” in running this piece. The facts before the

Administrative Law Judge and the Commission establish that we lack subject matter jurisdiction. Consistent with

the First Amendment, we have no choice but to dismiss the complaint.

II. RELEVANT BACKGROUND FACTS

The RJR piece, 4 “Of Cigarettes and Science,” was published in March 1985 in a number of newspapers and

magazines. (Abrams Aff. ¶ 2) In that communication, RJR argues that one set of scientific principles is being

used to judge most scientific matters but that a different set is being used for experiments involving cigarettes. In

support of this thesis, RJR cites its version of the scientific treatment of a study called the Multiple Risk Factor

Intervention Trial (MR FIT). The study, funded by the federal government, cost $115,000,000 and took ten years.

RJR's communication describes the study as follows:

*12 The subjects were over 12,000 men who were thought to have a high risk of heart disease because of three risk

factors that are statistically associated with this disease: smoking, high blood pressure and high cholesterol levels.

Half of the men received no special medical intervention. The other half received medical treatment that

consistently reduced all three risk factors, compared with the first group.

It was assumed that the group with lower risk factors would, over time, suffer significantly fewer deaths from

heart disease than the higher risk factor group.

But that is not the way it turned out.

After 10 years, there was no statistically significant difference between the two groups in the number of hear

disease deaths.
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The Commission does not allege that this description of the study is inaccurate. 5 Nor is it disputed that the results

of the MR FIT were not as expected. 6

After describing the study, RJR provides its view of the scientific reaction to that study:

We at R.J. Reynolds do not claim this study proves that smoking doesn't cause heart disease. But we do wish

to make a point.

Despite the results of MR FIT and other experiments like it, many scientists have not abandoned or modified their

original theory, or re-examined its assumptions.

They continue to believe these factors cause heart disease. But it is important to label their belief accurately. It

is an opinion. A judgment. But not scientific fact.

We believe in science. That is why we continue to provide funding for independent research into smoking and

health.

But we do not believe there should be one set of scientific principles for the whole world, and a different set for

experiments involving cigarettes. Science is science. Proof is proof. That is why the controversy over smoking

and health remains an open one. 7

The Administrative Law Judge determined that the characterization of “Of Cigarettes and Science” as commercial

speech or fully protected speech can be made from the face of the publication. 8 In summary, his conclusion was:

“From a common sense approach, Reynolds' ‘Of cigarettes and science’ is clearly an editorial; it is not commercial

speech by any stretch of the imagination.” 9

III. CONTROLLING SUPREME COURT PRECEDENT

The Supreme Court has recognized that corporations are free to engage in public debate and have a fully protected

right to do so, noting that: “[t]he inherent worth of the speech in terms of its capacity for informing the public does

not depend upon the identity of its source, whether corporation, association, union, or individual.” First National

Bank of Boston v. Belotti, 435 U.S. 765, 777 (1978), rehearing denied, 438 U.S. 907 (1978). Corporations, like

others, do not lose the protection of the First Amendment by virtue of the fact that they pay to make their views

known. In rejecting a claim that libelous statements received no protection because they had been paid for in an

advertisement attempting to raise funds, the Supreme Court stated:

*13 That the Times was paid for publishing the advertisement is as immaterial in this connection as is the fact

that newspapers and books are sold. Any other conclusion would discourage newspapers from carrying “editorial

advertisements” of this type, and so might shut off an important outlet for the promulgation of information and

ideas by persons who do not themselves have access to publishing facilities who wish to exercise their freedom

of speech even though they are not members of the press. The effect would be to shackle the First Amendment in

its attempt to secure the “widest possible dissemination of information from diverse and antagonistic sources.”

New York Times v. Sullivan, 376 U.S. 254, 266 (1964) (citations omitted). 10

Public debate is protected because, “above all else, the First Amendment means that government has no power to

restrict expression because of its message, its ideas, its subject matter, or its content.” 11 The government may not
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“select which issues are worth discussing or debating” and “must afford all points of view an equal opportunity

to be heard.” 12 “Selective exclusions from a public forum may not be based on content alone, and may not be

justified by reference to content alone.” 13

The First Amendment evidences a deliberate policy choice to limit the government's ability to control speech and

to rely instead on the abilities of the citizenry to judge the facts and opinions offered by themselves. That choice

is made with a clear view of the consequences, that “erroneous statement of fact is ... inevitable in free debate....

The First Amendment requires that we protect some falsehood in order to protect speech that matters.” Gertz v.

Robert Welch, Inc., 418 U.S. 323, 340-41 (1974). Such an accommodation is necessary to give freedom of speech

the “breathing space” which is necessary for its “fruitful exercise” (Id. at 342) and “survival.” NAACP v. Button,

371 U.S. 415, 433 (1963). Indeed, “[u]nder the First Amendment there is no such thing as a false idea .” Gertz,

supra, 418 U.S. at 339. This does not imply that the truth is not preferred, but that the arbiters should be the public

rather than the government. “If there be time to expose through discussion the falsehood and fallacies, to avert the

evil by the processes of education, the remedy to be applied is more speech, not enforced silence.” 14

Commercial speech, like debate over ideas, is protected under the First Amendment, but it receives a lower level

of protection. 15 The distinction is drawn to avoid “dilution, simply by a leveling process, of the force of the

Amendment's guarantee with respect to [noncommercial speech].” 16

Unlike noncommercial speech, commercial speech can be regulated to prohibit false and deceptive advertising.

The Supreme Court has cited two aspects of commercial speech that justify regulation based on the content of

the message:

First, commercial speakers have extensive knowledge of both the market and their products. Thus, they are well

situated to evaluate the accuracy of their messages and the lawfulness of the underlying activity. Bates v. State

Bar of Arizona, 433 U.S. 350, 381 (1977). In addition, commercial speech, the offspring of economic self-interest,

is a hardy breed of expression that is not “particularly susceptible to being crushed by overbroad regulation.”

*14 Central Hudson Gas & Electric Corp. v. Public Service Comm'n of New York, 447 U.S. at 564 n. 6.

The first basis for affording less protection to commercial speech, the relative costs of avoiding injury from

untruthful speech, is discussed more fully in Bates:

the advertiser seeks to disseminate information about a product or service that he provides, and presumably he

can determine more readily than others whether his speech is truthful and protected.

Bates v. State Bar of Arizona, 433 U.S. 350, 381 (1977).

The second basis for affording less protection to commercial speech, its hardiness because it is the offspring of

economic self-interest, was discussed in Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council,

Inc., 425 U.S. 748, n. 24 at 771-72 (1976):

Also, commercial speech may be more durable than other kinds. Since advertising is the sine qua non of

commercial profits, there is little likelihood of its being chilled by proper regulation and foregone entirely.

Since commercial speech is used to sell goods and services and is “related solely to the economic interests of the

speaker and its audience,” Central Hudson, supra, at 561, an advertiser expects to be able to capture a large percent

of the value of his commercial speech. By contrast, speech dealing with matters of public concern is potentially

of value to a much broader audience, i.e., to the public at large. Self-censorship is more likely to occur when
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speech relates to matters of public concern. To provide the necessary breathing space for vigorous public debate

involving matters of public controversy, potentially false statements in communications relating to such matters

receive a greater degree of protection under the First Amendment. 17

To aid in the process of distinguishing commercial speech from more traditional First Amendment expression, the

Supreme Court has provided two definitions of commercial speech. First, there is a “ ‘common-sense’ distinction

between speech proposing a commercial transaction, which occurs in an area traditionally subject to government

regulation, and other varieties of speech,” 18 or, as restated, the “core notion of commercial speech” is “speech

which does ‘no more than propose a commercial transaction’.” Bolger v . Youngs Drug Products Corp., 463 U.S.

60, 66 (1983). The other definition of commercial speech is “expression related solely to the economic interest

of the speaker and its audience.” Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S.

557, 561 (1980).

These two definitions of commercial speech may not comprehend all commercial speech, as evidenced by Bolger

v. Youngs Drug Products Corp., supra. Bolger involved a challenge to the application of a federal statute that

prohibited the mailing of unsolicited advertisements for contraceptives. After the Postal Service had advised

Youngs that certain proposed mailings would violate the statute, Youngs sought a ruling that the statute was

unconstitutional as applied to the mailings in question. The district court held that the three types of mailings in

question were all commercial solicitations but that the statutory prohibition was more extensive than necessary

to protect the interests asserted by the Government. 19 Accordingly, the district court held that the statute was

unconstitutional as applied.

*15 The Supreme Court affirmed the district court's ruling, but in the process addressed the question whether

the mailings were commercial speech. The Supreme Court concluded that the mailings were commercial speech.

Most of the mailings, it held, fell “within the core notion of commercial speech” since they did ‘no more than

propose a commercial transaction.’ Id. at 66. But the informational pamphlets could not “be characterized merely

as proposals to engage in commercial transactions.” 20

The Court concluded that the pamphlets could not be classified as commercial speech merely because they were

“conceded to be advertisements” (id. at 66), merely because of a “reference to a specific product” (id. at 66), or

merely because “Youngs has an economic motivation for mailing the pamphlets” (id. at 67). These three facts taken

together, in this particular case, were, however, enough to satisfy the Court that the pamphlets were commercial

speech: “The combination of all these characteristics, however, provides strong support for the District Court's

conclusion that the informational pamphlets are properly characterized as commercial speech.” (id. at 67).

The Bolger Court noted that the pamphlets at issue “contain[ed] discussions of important public issues,” Id.

at 67-68, but held that the informational pamphlets were commercial speech notwithstanding the discussion of

important public issues:

The mailings constitute commercial speech notwithstanding the fact that they contain discussions of important

public issues such as venereal disease and family planning. We have made clear that advertising which “links a

product to a current public debate” is not thereby entitled to the constitutional protection afforded noncommercial

speech. A company has the full panoply of protections available to its direct comments on public issues, so there

is no reason for providing similar constitutional protection when such statements are made in the context of

commercial transactions. Advertisers should not be permitted to immunize false or misleading product information

from government regulation simply by including references to public issues.

Id. at 67-68 (emphasis provided) (quoting Central Hudson Gas & Electric Corp. v. Public Service Commission

of New York, 447 U.S. 563, n. 5).
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The Bolger Court's distinction between “direct comments on public issues” and “advertising which ‘links a product

to a current public debate’ ” is best understood by reference to two Supreme Court decisions cited in Bolger:

Consolidated Edison Co. v. Public Service Commission, supra, and Central Hudson Gas & Electric Corp. v. Public

Service Commission of New York, supra.

In Consolidated Edison, Con Ed challenged a rule forbidding it from mailing, along with its billing statements,

leaflets discussing controversial issues of public policy. The rule had been promulgated in response to a Con Ed

leaflet proclaiming the benefits of nuclear power. The Supreme Court held that the rule conflicted with the First

Amendment, emphasizing that “[t]he First Amendment's hostility to content-based regulation extends not only to

restrictions on particular viewpoints, but also to prohibition of public discussion of an entire topic.” Consolidated

Edison Co. v. Public Service Commission, 447 U.S. at 537. The Court discussed its Consolidated Edison holding

in the companion Central Hudson case, stating: “[w]e rule today in Consolidated Edison Co. v. Public Service

Commission ... that utilities enjoy the full panoply of First Amendment protections for their direct comments on

public issues.” Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 477 U.S. at

563 n. 5.

*16 In the Central Hudson case, the plaintiff utility company challenged a rule that banned an electric utility from

advertising to promote the use of electricity. The rule was enacted in response to the perceived energy shortage.

The Supreme Court struck down the rule, holding that the public utility commissions' rule was more extensive

than necessary to further the state's interest in energy conservation.

In a concurring opinion, Justice Stevens criticized the regulation as banning all promotional advertising and thus

being overly broad:

This ban encompasses a great deal more than mere proposals to engage in certain kinds of commercial transactions.

It prohibits all advocacy of the immediate or future use of electricity. It curtails expression by an informed and

interested group of persons of their point of view on questions relating to the production and consumption of

electrical energy questions frequently discussed and debated by our political leaders.

Id. at 580-81 (Stevens, J., concurring in judgment).

In a footnote, the majority in Central Hudson discussed Justice Stevens' concerns. The majority concluded that the

advertising ban “was restricted to all advertising ‘clearly intended to promote sales'.” Id. at 562 n. 5. Further, while

the complaint and the lower court opinions viewed the litigation as involving only commercial speech, the majority

addressed the issue whether full First Amendment protection should be afforded to “all promotional advertising

that includes claims ‘relating to ... questions frequently discussed and debated by our political leaders' ”:

Although this approach responds to the serious issues surrounding our national energy policy as raised in this case,

we think it would blur further the line the Court has sought to draw in commercial speech cases. It would grant

broad constitutional protection to any advertising that links a product to a current public debate. But many, if not

most, products may be tied to public concerns with the environment, energy, economic policy, or individual health

and safety. We rule today in Consolidated Edison Co. v. Public Service Comm'n, ante, 530, that utilities enjoy

the full panoply of First Amendment protection for their direct comments on public issues. There is no reason

for providing similar constitutional protection when such statements are made only in the context of commercial

transactions.

Id. at 563 n. 5.
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A simple message flows from these cases. In Consolidated Edison the Court held that the First Amendment did

not allow the government to foreclose discussion of an entire topic the benefits of nuclear power. In dealing with

broad categories of messages, the Court has gone no further than deciding that those ‘clearly intended to promote

sales' could be treated as commercial speech. Central Hudson, supra, at 565 n. 5. Moreover, if companies attempt

to evade regulation of commercial speech by including gratuitous references to public issues the court will not

countenance it. Bolger, supra, at 68. There is no need to allow that sort of subterfuge because companies have full

First Amendment rights to make their views known in other ways. Id.

*17 The dividing line is thus clear if, by a common sense view, the advertisement is clearly intended to promote

sales it is commercial speech. If, in addition, there is a public message incorporated, the advertisement can be

regulated if inclusion of that public message is simply a gratuitous linkage. If, however, the message is direct

comment on a public issue, the full protection of the First Amendment applies. If direct comment on public issues

cannot be severed from speech that otherwise might be characterized as commercial speech because it may affect

sales, i.e., if the two parts are inextricably intertwined, the full protection of the First Amendment must be afforded

to direct comment on public issues. Otherwise, the speaker would be selectively excluded from participating in a

public discussion of an entire topic, an outcome precluded by the First Amendment.

I point out, however, that my reading of the controlling Supreme Court precedent is not shared by the Commission

majority. The Commission majority (pp. 13-14) reasons as follows:

Although it may be difficult in some cases, the Commission thinks that it is possible to determine whether a

specific advertisement that includes information connected to public issues nonetheless addresses the concerns of

a purchaser of the advertiser's product or service. To conclude otherwise would allow sellers of certain products

to avoid the proscription against false and misleading advertising merely by linking their product to a public issue.

Note that the Commission majority uses the words “whether” and “nonetheless.” In the view of the Commission

majority, a communication that “addresses the concerns of a purchaser of the advertiser's product or service” can

never be fully protected speech, no matter how close the link between the public issue addressed and the potential

commercial effect that may arise because the communication deals in part with a characteristic of the speaker's

product or service of interest to consumers. Under the Commission majority's analysis, a product manufacturer

loses its fully protected right to engage in debate over a matter of public concern whenever the public issue is

the manufacturer's product.

On this critical issue, the Commission majority and I part company. On my reading of the controlling Supreme

Court precedent, a product manufacturer cannot be selectively excluded from participating in a public discussion

of an entire topic. I conclude that product manufacturers, like everyone else, “enjoy the full panoply of First

Amendment protection for their direct comments on public issues,” Central Hudson, supra, at 563 n. 5; that

they cannot be singled out for “[s]elective exclusions from a public forum ... based on content alone ... [or]

justified by reference to content alone,” Police Department of Chicago v. Mosely, supra, at 96; that they cannot

be barred from “public discussion of an entire topic,” Consolidated Edison Co. v. Public Service Commission,

supra, at 537; and that this full First Amendment protection is not lost unless the consequence would be to allow a

product manufacturer “to immunize false or misleading product information from government regulation simply

by including references to public issues.” Bolger, supra, at 68 (emphasis supplied).

III. CHARACTERIZATION OF THE RJR COMMUNICATION

*18 RJR's “Of Cigarettes and Science” does not come within either of the two Supreme Court definitions of

commercial advertising. It does more far more than propose a commercial transaction. It does not relate solely to

the economic interest of the speaker and its audience.
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Nor would regulation of the RJR piece come within the rationales provided for the commercial speech distinction.

The verifiability rationale does not apply because the claims made in “Of Cigarettes and Science” do not address

an aspect of cigarettes uniquely within the knowledge of RJR. Since the MR FIT study was not conducted by

RJR, others can determine as readily as RJR whether the statements in “Of Cigarettes and Science” are truthful. 21

Nor does the hardiness rationale apply. Since the subject matter discussed by RJR is a matter of public concern,

this type of speech by RJR is particularly susceptible to being crushed by regulation. Noncommercial speech by a

firm such as RJR about public issues related to its products may well be chilled by discriminatory governmental

regulation or by the threat of expensive investigations or litigation. Indeed, RJR terminated its entire series of

editorial-like communications once the FTC began this proceeding.

In addition to not fitting within the definitions or the rationales of commercial speech, the RJR communication

does not fit within the three Bolger criteria. Although RJR undoubtedly had an economic motivation in paying

for its publication, “Of Cigarettes and Science” is hardly an advertisement in the ordinary sense of that word; 22

indeed, it refers only to a generic rather than a particular product. 23

Even if “Of Cigarettes and Science” affects the sales of cigarettes, there is no question that it is also a direct

comment on a matter of public concern. 24 The question thus arises whether “Of Cigarettes and Science”

gratuitously invokes a matter of public concern. The answer is clear. There is no gratuitous link. The effect of

cigarettes on health is itself the issue of public concern. RJR cannot possibly make its argument about the correct

conclusions to be drawn from MR FIT without at the same time discussing an attribute of cigarette smoking of

concern to purchasers of its product.

If RJR is not permitted to publish a piece such as “Of Cigarettes and Science” without the fear of government

censorship, then there is simply no way for RJR to engage effectively in the debate over cigarette smoking and

health free from governmental oversight determining the truth or falsity of RJR's arguments. 25 RJR cannot argue

about the lack of conclusiveness of scientific evidence without at the same time potentially influencing consumers'

purchase decisions.

Virtually every other person and corporation in America is free to participate in the debate about cigarette

smoking and health, without government evaluation whether their claims are true or false. Whether or not RJR's

participation in the debate is “unfair or deceptive,” its speech challenged by this proceeding is undoubtedly a part

of the contest of ideas. Under the First Amendment, RJR cannot be selectively excluded from participating in that

debate merely because it produces cigarettes.

*19 Since “Of Cigarettes and Science” is a direct comment on a public issue, RJR cannot, consistent with the

First Amendment, be precluded from publishing that comment. Can anyone doubt that a Congressional ban on all

cigarette advertising 26 could not constitutionally be applied to the type of statement at issue in this case? And if

Congress cannot ban such a communication, how can the Federal Trade Commission regulate its content?

Consider the ironic result if “Of Cigarettes and Science” were held to be commercial speech. In that event, the

RJR communication would be deemed to be a cigarette advertisement. As such, it would have to carry one of the

four Surgeon General rotational health warnings. 27 Thus, an RJR editorial arguing that there is lack of definitive

evidence on smoking and heart disease would have to be accompanied by a governmentally mandated warning

that “Smoking Causes ... Heart Disease ...”

Quite simply, this case involves attempted federal regulation of the content of a communication that engages in

a debate over ideas. RJR is forced to undergo this proceeding in part because it has the temerity to argue, in the

words of the Commission's complaint, that “[a] major government study about smoking and coronary heart disease
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(the MR FIT study) provides credible scientific evidence that smoking is not as hazardous as the public or the

reader has been led to believe ...” 28 RJR is in a distinct minority. It has challenged the official position taken by

the Surgeon General and the United States Congress. RJR may be wrong. But on my reading of the Constitution,

that determination is to be made by each individual, not by the government.

IV. THE MAJORITY'S BASES FOR NOT DISMISSING THE COMPLAINT

A. Propriety of Postponing a Ruling on Jurisdiction

Although this case in on appeal from an Administrative Law Judge's determination that the Commission lacks

subject matter jurisdiction because the communication is fully protected speech, the majority has declined

to determine whether the RJR communication is commercial speech or noncommercial speech. Postponing a

ruling on the determinative First Amendment question might be understandable (even if wrong) if the majority

had determined that further discovery were necessary before the Commission could make such a ruling. The

Commission majority has not, however, made any such determination. Absent a holding that the Commission

needs more evidence to decide whether the communication is commercial speech, the majority has no justifiable

basis for not ruling on that issue.

The apparent explanation for the majority's action (or inaction) is their assertion: “Accepting the allegations of the

complaint concerning jurisdiction as true for purposes of this appeal, the content of the Reynolds advertisement

includes words and messages that are characteristic of commercial speech.” (p. 15, citation omitted) This

explanation, however, provides no basis for not ruling on the commercial speech question. The complaint's

allegations referred to by the majority discuss facts that are apparent from the face of the RJR communication

itself. Since the RJR communication is itself attached to and incorporated within the complaint, the complaint by

itself, under the majority's own reasoning, provides a full basis for ruling on the question of commercial versus

noncommercial speech.

*20 Consider the complaint allegations cited by the majority. First, the majority cites the complaint for the

proposition that RJR's communication “refers to a specific product, cigarettes” and “discusses an important

product attribute the alleged connection between smoking and heart disease.” (p. 15) These facts are apparent

from the face of the communication. Second, the majority states: “the Complaint alleges that ‘Of Cigarettes and

Science’ is an advertisement (Complaint ¶ 2), which we understand to mean a notice or announcement that is

publicly published or broadcast and is paid-for.” (pp. 15-16) The communication evidences on its face that it

was publicly published. RJR's name at the bottom of the communication indicates that the communication was

paid for by RJR. Finally, the majority states: “the Complaint alleges that Respondent is in the business of selling

cigarettes.” The communication itself reveals that it was presented by R.J. Reynolds Tobacco Company; the name

and the content of the communication indicate that RJR is in the business of selling cigarettes.

On the basis of the complaint allegations cited above, the majority asserts, “the content of the Reynolds

advertisement includes words and messages that are characteristic of commercial speech.” Having made this

determination, the Commission majority must logically conclude that the communication is commercial speech

unless (1) there is some step between having the characteristics of commercial speech and being commercial

speech or (2) there is a possible characteristic of a communication that will cause it be fully protected even though

it also has the characteristics of commercial speech. Since the Commission majority has already excluded the

second possibility, 29 only the first possibility could possibly remain. As to that possibility, I can only ask: what

step could there be between having the characteristics of commercial speech and being commercial speech? As I

read the complaint and the majority opinion, the Commission majority has, whether it realizes it or not, already

concluded that the communication is commercial speech.
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B. Propriety of Further Discovery

As a means of possibly garnering additional support for a finding that the Commission has subject matter

jurisdiction, the majority has instructed the Administrative Law Judge to permit further discovery. The further

discovery suggested by the majority is irrelevant. Accordingly, such discovery itself would be an unjustifiable

burden on RJR's exercise of the First Amendment rights.

The Commission majority suggests two lines of discovery. The first line relates to the publication itself (p. 20):

Evidence that may be relevant to deciding whether the Reynolds advertisement is commercial speech includes

facts concerning the publication or dissemination of the advertisement, such as whether it was paid-for, where

and in which publications it was disseminated, whether it was placed in editorial space (such as an op-ed page)

or advertising space in the publication, whether it was prepared as a letter to the editor, whether it was sent to

representatives of the media for selection on merit by editorial boards, and to whom it was disseminated outside

the media.

*21 No discovery is necessary or relevant regarding background information of this type. 30 From the face of the

publication, it is self-evident where it was published. The communication was not on an opened page nor a “letter

to the editor.” Since RJR's name appears at the bottom of the communication, the indication is that RJR paid for the

publication. Whether the communication “was disseminated outside the media” is irrelevant. If the communication

as published is commercial speech, it does not become any less so by virtue of having been disseminated outside

the media. If the communication as published is not commercial speech, dissemination outside the media would

not provide a basis for Commission action because such dissemination is not alleged in the complaint.

The second line of discovery suggested by the majority relates to RJR's intent in publishing the communication.

(p. 20-21):

Evidence about the promotional nature of the advertisement also may be relevant. Therefore, it might be useful

to consider the circumstances surrounding the development of the advertisement, such as whether it was targeted

to consumers or legislators; whether it was intended to affect demand for Reynolds' cigarettes or brands or to

affect particular legislative or regulatory proposals; whether the advertisement was subjected to copy testing or

to review by focus groups and, if so, the nature of the questions used in the copy tests or focus group sessions;

and the results of those procedures both in terms of what they showed and what changes, if any, Reynolds made

in response to those showings. Evidence relating to the message(s) Reynolds itself intended to convey through

the advertisement also may be relevant. In addition, Reynolds' share of the cigarette market may be relevant to

deciding whether including a brand name reference is a prerequisite to a determination that the advertisement

constitutes commercial speech.

In deciding whether a publication is commercial speech, the Supreme Court has never looked to the subjective

intent of the speaker. 31 Objective standards are essential. Otherwise, there will be a chilling of fully protected

speech. If the Commission cannot determine from the face of a publication that it is commercial speech, it has no

basis for challenging such a publication. A fishing expedition to determine the subjective intent of particular RJR

employees would impose an unjustifiable burden on RJR and chill its right to engage in free speech.

V. CONCLUSION

R.J. Reynolds has full First Amendment rights for its direct comments on public issues. “Of Cigarettes and

Science” is patently direct comment on a public issue. In this case, it is precisely the product that is the public

issue. Discussion of the health consequences of smoking can hardly be labeled a mere gratuitous linking of a
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product with a current public debate. 32 If corporations have full First Amendment rights they must be allowed

to participate in the public debate about issues involving their products, at least in an editorial format. Effectively

removing a company from a debate by contending that its message about its product is deceptive would infringe

on its basic constitutional rights. In such a public debate the decision regarding truth and falsity must be made by

the public, not the government. This is particularly true when the government itself has taken a public position and

established its own orthodoxy. Having done so, it cannot then prohibit challenges to the governmentally approved

version of the truth.

*22 Publication of RJR's communication may or may not have an effect on cigarettes sales and such an effect

may or may not have been intended. In my view, that is irrelevant. Extrinsic evidence of RJR's intentions is not

needed to decide whether this communication is fully protected. It is, on its face, direct comment on a public

issue and not commercial speech. To conclude otherwise would turn a common-sense distinction into an intrusive

inquiry into facts about the motives of the speaker. If the editorial is deceptive, or not believable, or runs counter

to other information on the health question that the public is aware of, consumers are free to reject the message

in the editorial. But it is critical for First Amendment purposes that the public, and not the government, decide

the answer to this question. To conclude otherwise would erode First Amendment protection by extending the

commercial speech doctrine into areas traditionally thought to be fully protected. Governmental inquiry into the

motives of the speaker to determine if his views are to be constitutionally protected seems to me completely

antithetical to the goals the First Amendment as intended to further. I would affirm the Administrative Law Judge

and dismiss the complaint.

EXHIBIT 1

*23 Of cigarettes and science.

This is the way science is supposed to work.

A scientist observes a certain set of facts. To explain these facts, the scientist comes up with a theory.

Then, to check the validity of the theory, the scientist performs an experiment. If the experiment yields positive

results, and is duplicated by other scientists, then the theory is supported. If the experiment produces negative

results, the theory is re-examined, modified or discarded.

But, to a scientist, both positive and negative results should be important. Because both produce valuable learning.

Now let's talk about cigarettes.

You probably know about research that links smoking to certain diseases. Coronary heart disease is one of them.

Much of this evidence consists of studies that show a statistical association between smoking and the disease.

But statistics themselves cannot explain why smoking and heart disease are associated. Thus, scientists have

developed a theory: that heart disease is caused by smoking. Then they performed various experiments to check

this theory.

We would like to tell you about one of the most important of these experiments.

A little-known study
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It was called the Multiple Risk Factor Intervention Trial (MRFIT).

In the words of the Wall Street Journal, it was “one of the largest medical experiments ever attempted.” Funded

by the Federal government, it cost $115,000,000 and took 10 years, ending in 1982.

The subjects were over 12,000 men who were thought to have a high risk of heart disease because of three risk

factors that are statistically associated with this disease: smoking, high blood pressure and high cholesterol levels.

Half of the men received no special medical intervention. The other half received medical treatment that

consistently reduced all three risk factors, compared with the first group.

It was assumed that the group with lower risk factors would, over time, suffer significantly fewer deaths from

heart disease than the higher risk factor group.

But that is not the way it turned out.

After 10 years, there was no statistically significant difference between the two groups in the number of heart

disease deaths.

The theory persists

We at R.J. Reynolds do not claim this study proves that smoking doesn't cause heart disease. But we do wish

to make a point.

Despite the results of MR FIT and other experiments like it, many scientists have not abandoned or modified their

original theory, or re-examined its assumptions.

They continue to believe these factors cause heart disease. But it is important to label their belief accurately. It

is an opinion. A judgment. But not scientific fact.

We believe in science. That is why we continue to provide funding for independent research into smoking and

health.

But we do not believe there should be one set of scientific principles for the whole world, and a different set for

experiments involving cigarettes. Science is science. Proof is proof. That is why the controversy over smoking

and health remains an open one.

*24 R.J. Reynolds Tobacco Company

EXHIBIT 2-A

Can we have an open debate about smoking?

The issues that surround smoking are so complex, and so emotional, it's hard to debate them objectively.

In fact, many of you probably believe there is nothing to debate.
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Over the years, you've heard so many negative reports about smoking and health and so little to challenge these

reports that you may assume the case against smoking is closed.

But this is far from the truth.

Studies which conclude that smoking causes disease have regularly ignored significant evidence to the contrary.

These scientific findings come from research completely independent of the tobacco industry.

We at R.J. Reynolds think you will find such evidence very interesting. Because we think reasonable people who

analyze it may come to see this issue not as a closed case, but as an open controversy.

We know some of you may be suspicious of what we'll say, simply because we're a cigarette company.

We know some of you may question our motives.

But we also know that by keeping silent, we've contributed to this climate of doubt and distrust. We may also

have created the mistaken impression that we have nothing to say on these issues.

That is why we've decided to speak out now, and why we intend to continue speaking out in the future.

During the coming months we will discuss a number of key questions relating to smoking and health. We will

also explore other important issues including relations between smokers and non-smokers, smoking among our

youth, and “passive smoking.”

Some of the things we say may surprise you. Even the fact that we say them may prove controversial.

But we won't shy away from the controversy because, quite frankly, that's our whole point.

We don't say there are no questions about smoking. Just the opposite. We say there are lots of questions but, as

yet, no simple answers.

Like any controversy, this one has more than one side. We hope the debate will be an open one.

R.J. Reynolds Tobacco Company

EXHIBIT-2B

What not to do in bed.

You can read.

You can rest.

You can sleep.

You can make phone calls.

You can eat breakfast.
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You can watch television.

You can listen to music.

You can exercise.

You can snore.

You can even eat crackers provided you're alone.

And yes, you can snuggle.

But don't ever light up a cigarette when you're in bed.

Because if you doze off just once, all your dreams can go up in smoke.

R.J. Reynolds Tobacco Company

EXHIBIT 2-C

A message from those who don't to those who do.

We're uncomfortable.

To us, the smoke from your cigarettes can be anything from a minor nuisance to a real annoyance.

We're frustrated.

Even though we've chosen not to smoke, we're exposed to second-hand smoke anyway.

We feel a little powerless.

Because you can invade our privacy without even trying. Often without noticing.

*25 And sometimes when we speak up and let you know how we feel, you react as though we were the bad guys.

We're not fanatics. We're not out to deprive you of something you enjoy. We don't want to be your enemies.

We just wish you'd be more considerate and responsible about how, when, and where you smoke.

We know you've got rights and feelings. We just want you to respect our rights and feelings, as well.

A message from those who do to those who don't.

We're on the spot.

Smoking is something we consider to be a very personal choice, yet it's become a very public issue.
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We're confused.

Smoking is something that gives us enjoyment, but it gives you offense.

We feel singled out.

We're doing something perfectly legal, yet we're often segregated, discriminated against, even legislated against.

Total strangers feel free to abuse us verbally in public without warning.

We're not criminals. We don't mean to bother or offend you. And we don't like confrontations with you.

We're just doing something we enjoy, and trying to understand your concerns.

We know you've got rights and feelings. We just want you to respect our rights and feelings, as well.

Brought to you in the interest of common courtesy by

R.J. Reynolds Tobacco Company

EXHIBIT 2-D

Smoking in public:

Let's separate fact

from friction.

There has always been some friction between smokers and non-smokers. But lately this friction has grown more

heated.

The controversy has been fueled by questionable reports which claim that “second-hand smoke” is a cause of

serious diseases among non-smokers.

But, in fact, there is little evidence and certainly nothing which proves scientifically that cigarette smoke causes

disease in non-smokers.

Skeptics might call this the wishful thinking of a tobacco company. But consider the scientific judgment of some

of the leading authorities in the field including outspoken critics of smoking.

For example, in 1983 the organizer of an international conference on environmental tobacco smoke (ETS)

summarized the evidence on lung cancer as follows: “An overall evaluation based upon available scientific data

leads to the conclusion that an increased risk for non-smokers from ETS exposure has not been established.”

Even the chief statistician of the American Cancer Society, Lawrence Garfinkel, has gone on record as saying,

“passive smoking may be a political matter, but it is not a main issue in terms of health policy.”

Which brings us back to our original point: cigarette smoke can be very annoying to non-smokers.
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But how shall we as a society deal with this problem?

Confrontation? Segregation? Legislation?

No. We think annoyance is neither a governmental problem nor a medical problem. It's a people problem.

Smokers and non-smokers have to talk to one another. Not yell, preach, threaten, badger or bully. Talk.

Smokers can help by being more considerate and responsible. Non-smokers can help by being more tolerant. And

both groups can help by showing more respect for each other's rights and feelings.

*26 But eliminating rumor and rhetoric will help most of all.

Because when you stick to the facts, it's a lot easier to deal with the friction.

R.J. Reynolds Tobacco Company

EXHIBIT 2-E

We don't advertise to children.

Who are you kidding?

The newspapers and magazines and billboards are filled with cigarette ads. Kids can't help but see them.

How can you expect us to believe you're not trying to reach and influence our children?

We're not surprised if many people feel this way especially when years of negative publicity have made them

totally cynical about our industry.

Nevertheless, we'd like to set the record straight.

First of all, we don't want young people to smoke. And we're running ads aimed specifically at young people

advising them that we think smoking is strictly for adults.

Second, research shows that among all the factors that can influence a young person to start smoking, advertising

is insignificant. Kids just don't pay attention to cigarette ads, and that's exactly as it should be.

Finally and this is sometimes hard for people outside the marketing field to understand all of our cigarette ads are

what we call “brand advertising.” Its purpose is to get smokers of competitive products to switch to one of our

brands, and to build the loyalty of those who already smoke one of our brands.

At the present there are some 200 different cigarette brands for sale in the U.S. Many of them have only a very

small fraction of the total cigarette market. Getting smokers to switch is virtually the only way a cigarette brand

can meaningfully increase its business.

That's why we don't advertise to young people.

Of course, if you'd like to share this ad with your children, that would be just fine with us.
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R.J. Reynolds Tobacco Company

EXHIBIT 2-F

Second-Hand Smoke:

The Myth

and The Reality.

Many non-smokers are annoyed by cigarette smoke. This is a reality that's been with us for a long time.

Lately, however, many non-smokers have come to believe that cigarette smoke in the air can actually cause disease.

But, in fact, there is little evidence and certainly nothing which proves scientifically that cigarette smoke causes

disease in non-smokers.

We know this statement may seem biased. But it is supported by findings and views of independent scientists

including some of the tobacco industry's biggest critics.

Lawrence Garfinkel of the American Cancer Society, for example. Mr. Garfinkel, who is the Society's chief

statistician, published a study in 1981 covering over 175,000 people, and reported that “passive smoking” had

“very little, if any” effect on lung cancer rates among non-smokers.

You may have seen reports stating that in the course of an evening, a non-smoker could breathe in an amount of

smoke equivalent to several cigarettes or more.

But a scientific study by the Harvard School of Public Health, conducted in various public places, found that nonsmokers might inhale anywhere from 1/1000th to 1/100th of one filter cigarette per hour. At that rate, it would

take you at least 4 days to inhale the equivalent of a single cigarette.

*27 Often our own concerns about our health can take an unproven claim and magnify it out of all proportion;

so, what begins as a misconception turns into a frightening myth.

Is “second-hand smoke” one of these myths? We hope the information we've offered will help you sort out some

of the realities.

R.J. Reynolds Tobacco Company

EXHIBIT 2-G

Second-hand smoke:

Let's clear the air.

Can cigarette smoke in the air cause disease in non-smokers?
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That's an emotional question for smokers and non-smokers alike. So we'll try to set the record straight in the most

direct way we know.

There is little evidence and certainly nothing which proves scientifically that cigarette smoke causes disease among

non-smokers.

You don't have to take our word for it.

U.S. Surgeon General Julius B. Richmond who was no friend of smoking said in his 1979 Report: “Healthy nonsmokers exposed to cigarette smoke have little or no physiologic response to the smoke, and what response does

occur may be due to psychological factors.”

And in the 1982 Report, Surgeon General C. Everett Koop could not conclude that passive smoking is a cause

of cancer in non-smokers.

The director of the National Heart, Lung and Blood Institute, Dr. Claude Lenfant, has been one of the tobacco

industry's sharpest critics. Yet Dr. Lenfant stated in 1980 (and we believe it remains true today) that “the evidence

that passive smoking in a general environment has health effects remains sparse, incomplete and sometimes

unconvincing.”

We've decided to speak out on passive smoking because there is so much rumor and rhetoric on this subject today.

And we intend to continue, from time to time, to speak out on other topics of concern to you and to us.

Our critics may try to discredit these messages as self-serving. In a sense, they will be right. We will challenge

allegations that are unproven and attacks we think are unfounded. If that is self-serving, so be it.

The questions that surround smoking raise many important issues. We believe that you're entitled to hear all sides

of these controversies.

R.J. Reynolds Tobacco Company

EXHIBIT 2-H

How to handle

peer pressure.

If some of your friends smoke, and they make you feel like you should smoke, too, that's “peer pressure.”

But even though we're a cigarette company, we think young people shouldn't smoke. Even the decision to smoke

or not to smoke should wait until you're an adult.

So we put together these ideas to help you recognize peer pressure and resist it.

Tactic # 1: Go ahead and take a puff what's the matter, are you chicken?

Answer: You must think I'm pretty dumb to fall for that one. It takes a lot more guts to do your own thing than

to just go along with the crowd.

Tactic # 2: Come on, all the cool kids smoke.
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Answer: Maybe the kids who smoke are trying to look cool. But if they really were cool, maybe they wouldn't

have to try so hard.

*28 Tactic # 3: Hey, I'm your friend would I steer you wrong?

Answer: Friends are people who like you for who you are, not for what they want you to be. If you're really my

friend, back off.

Tactic # 4: Do you want everybody to think you're a nerd?

Answer: Sure I care what other kids think of me. But if they base their opinions on stuff like smoking, their

opinions aren't worth much.

Tactic # 5: I bet you're just scared your parents will find out.

Answer: I wouldn't blame my parents for getting teed off. How can I expect them to treat me like an adult if I

sneak around and act like a kid?

It's natural for you to want to be just like your friends.

But if you don't smoke, maybe your friends will want to be just like you.

R.J. Reynolds Tobacco Company

EXHIBIT 2-I

Some surprising advice to young people from R.J. Reynolds Tobacco.

Don't smoke.

For one thing, smoking has always been an adult custom. And even for adults, smoking has become very

controversial.

So even though we're a tobacco company, we don't think it's a good idea for young people to smoke.

Now, we know that giving this kind of advice to young people can sometimes backfire.

But if you take up smoking just to prove you're an adult, you're really proving just the opposite.

Because deciding to smoke or not to smoke is something you should do when you don't have anything to prove.

Think it over.

After all, you may not be old enough to smoke. But you're old enough to think.

R.J. Reynolds Tobacco Company
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EXHIBIT 2-J

Passive smoking:

An active controversy.

Periodically the public hears about an individual scientific study which claims to show that “environmental tobacco

smoke” (ETS) may be harmful to non-smokers. These reports usually receive sensational media coverage.

Yet, three times within two years, groups of distinguished experts have gathered to review not just one study but

the whole body of evidence on this subject. In all three cases, the scientists came to similar and far less sensational

conclusions.

Yet the media have remained almost silent.

In March 1983 there was the “Second Workshop on Environmental Tobacco Smoke” in Geneva, Switzerland.

In May 1983 there was the “Workshop on Respiratory Effects of Involuntary Smoke Exposure” in Bethesda,

Maryland.

And, most recently, in April 1984, leading experts from around the world gathered in Vienna for a symposium,

“Passive Smoking from a Medical Point of View.”

After this symposium was over, the presidents of the two organizing groups issued a press release summarizing

their findings.

The summary said, “the connection between [ETS] and lung cancer has not been scientifically established to date.”

It also said “there is a high probability that cardiovascular damage due to [ETS] can be ruled out in healthy people.”

And it went on to say, “Should law-makers wish to take legislative measures with regard to [ETS], they will, for

the present, not be able to base their efforts on a demonstrated health hazard from [ETS].”

*29 Perhaps the media would say they cannot be blamed for devoting little attention to what some would consider

“non-news.” But we at R.J. Reynolds are concerned about the effects such one-sided coverage may be having

on the public.

For today, many non-smokers who once saw cigarette smoke merely as an annoyance now view it as a threat to

their health. Their growing alarm is being translated into heightened social strife and unfair anti-smoker legislation.

We believe these actions are unwarranted by the scientific facts and that it is rhetoric, more than research, which

makes passive smoking an active controversy.

R.J. Reynolds Tobacco Company

EXHIBIT 2-K

Of cigarettes and science.

This is the way science is supposed to work.
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A scientist observes a certain set of facts. To explain these facts, the scientist comes up with a theory.

Then, to check the validity of the theory, the scientist performs an experiment. If the experiment yields positive

results, and is duplicated by other scientists, then the theory is supported. If the experiment produces negative

results, the theory is re-examined, modified or discarded.

But, to a scientist, both positive and negative results should be important. Because both produce valuable learning.

Now let's talk about cigarettes.

You probably know about research that links smoking to certain diseases. Coronary heart disease is one of them.

Much of this evidence consists of studies that show a statistical association between smoking and the disease.

But statistics themselves cannot explain why smoking and heart disease are associated. Thus, scientists have

developed a theory: that heart disease is caused by smoking. Then they performed various experiments to check

this theory.

We would like to tell you about one of the most important of these experiments.

A little-known study

It was called the Multiple Risk Factor Intervention Trial (MRFIT).

In the words of the Wall Street Journal, it was “one of the largest medical experiments ever attempted.” Funded

by the Federal government, it cost $115,000,000 and took 10 years, ending in 1982.

The subjects were over 12,000 men who were thought to have a high risk of heart disease because of three risk

factors that are statistically associated with this disease: smoking, high blood pressure and high cholesterol levels.

Half of the men received no special medical intervention. The other half received medical treatment that

consistently reduced all three risk factors, compared with the first group.

It was assumed that the group with lower risk factors would, over time, suffer significantly fewer deaths from

heart disease than the higher risk factor group.

But that is not the way it turned out.

After 10 years, there was no statistically significant difference between the two groups in the number of heart

disease deaths.

The theory persists

We at R.J. Reynolds do not claim this study proves that smoking doesn't cause heart disease. But we do wish

to make a point.

*30 Despite the results of MRFIT and other experiments like it, many scientists have not abandoned or modified

their original theory, or re-examined its assumptions.
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They continue to believe these factors cause heart disease. But it is important to label their belief accurately. It

is an opinion. A judgment. But not scientific fact.

We believe in science. That is why we continue to provide funding for independent research into smoking and

health.

But we do not believe there should be one set of scientific principles for the whole world, and a different set for

experiments involving cigarettes. Science is science. Proof is proof. That is why the controversy over smoking

and health remains an open one.

R.J. Reynolds Tobacco Company

EXHIBIT 2-L

Smoking in public:

A radical proposal.

These days the level of social discourse between smokers and non-smokers is approaching that of a tag-team

wrestling match.

While some people try to solve this problem through segregation or confrontation, we at R.J. Reynolds have been

proposing a more daring solution: greater courtesy.

For these outlandish views we might be called dreamers and cockeyed optimists. But we continue to believe in

the power of politeness to change the world.

We can almost imagine how it might begin.

A smoker is about to light a cigarette in public. He pauses in mid-match, suddenly conscious of the non-smoker

next to him. Bracing himself for a hostile response, he asks, “Excuse me, do you mind if I smoke?”

The non-smoker is momentarily stunned by this unexpected act of courtesy. She stifles several witty replies that

leap to mind; she cannot let his politeness go unchallenged. “I don't mind,” she answers, “as long as you don't

let your smoke blow in my face.”

Her flagrant tolerance puts the smoker on the defensive. But he tries to regain the upper hand. “I'll do my best,”

he responds. “Let me know if the smoke bothers you.”

A deft comeback. But the non-smoker presses her attack: “I will and thanks for asking.” Not to be outdone, the

smoker brazenly replies, “Thanks for being so understanding.”

An unlikely dialogue? Perhaps. But, who knows? If this sort of thing ever caught on, it might lead to a sudden

outbreak of civil decency. Or even escalate into full-scale friendliness.

Common courtesy. It's just crazy enough, it might work.

Brought to you in the interest of common courtesy by
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R.J. Reynolds Tobacco Company

EXHIBIT 2-M

The most inflammatory question of our time.

“Hey, would you put out that cigarette?”

Just seven little words. But in today's over-heated climate of opinion, they can make sparks fly.

For with all the rhetoric about “second-hand smoke,” many non-smokers are beginning to feel not just bothered

but threatened by cigarettes.

And with all the talk about anti-smoking legislation, many smokers are beginning to feel threatened by nonsmokers.

*31 This is not exactly a recipe for social harmony. In fact, it's practically a guarantee of further discord.

Since we have discussed scientific aspects of the “passive smoking” controversy in previous messages, we'd like

to focus here on the social questions.

Will more confrontation or more segregation produce less abrasion? Do we solve anything by creating yet another

way to divide our society? Shouldn't all of us be wary of inviting government to involve itself further in our

private lives?

At R.J. Reynolds, we see an alternative.

We think we should start not by raising barriers, but by lowering our voices. We think smokers and non-smokers

can work out their differences together, in a spirit of tolerance and fairness and respect for each other's rights and

feelings. We think common courtesy can succeed where coercion is bound to fail.

And maybe, after we have learned peaceful coexistence by talking to each other civilly and sensibly, we can apply

the same approach to our many other problems.

Because, after all, this is hardly the most inflammatory question of our time.

Brought to you in the interest of common courtesy by

R.J. Reynolds Tobacco Company

EXHIBIT 2-N

Does smoking really make you look more grown up?

It's a crazy world.

Most adults we know would love to look younger than they really are. While most young people are busy trying

to look more adult.
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This is one reason why many young people take up smoking.

Well, we wish they wouldn't.

For one thing, it doesn't work. A fifteen-year-old smoking a cigarette looks like nothing more or less than a fifteenyear-old smoking a cigarette.

Even though we're a tobacco company, we don't think young people should smoke. There is plenty of time later

on to think about whether or not smoking is right for you.

Besides, when you think about it, being grown up is highly overrated. You have to go to work, pay taxes, wear

normal clothes and raise kids who grow up to be teenagers.

Why be in such a hurry?

R.J. Reynolds Tobacco Company

EXHIBIT 2-O

The second-hand smokescreen.

For decades, public and private organizations have waged a massive campaign to discourage cigarette smoking.

For most of that time, the target of this effort has been the smoker.

Recently, however, the emphasis has undergone a major shift. Today there are scientists who claim that cigarette

smoke in the air can actually cause disease in non-smokers. We hear a great deal about “second-hand smoke”

and “passive smoking.”

But is this new approach wholly motivated by concern for the non-smoker, or is it the same old war on smoking

in a new guise?

These doubts are raised when we recall statements like the following, by a spokesperson for the American Lung

Association:

Probably the only way we can win a substantial reduction [in smoking] is if we can somehow make it nonacceptable

socially.... We thought the scare of medical statistics and opinions would produce a major reduction. It really didn't.

*32 Obviously, one way to make smoking “nonacceptable socially” would be to suggest that second-hand smoke

could cause disease. So it is not surprising that we are now seeing a flurry of research seeking scientific support

for these suggestions.

Many independent experts believe the scientific evidence on passive smoking is questionable. But a zealous group

of anti-smokers are using this issue in their campaign against tobacco as if the claims were established scientific

fact.

We deplore the actions of those who try to manipulate public opinion through scare tactics. As the late, respected

pathologist, Dr. H. Russell Fisher, stated in testimony submitted to a Congressional hearing on passive smoking:

... [I]n the absence of any scientific proof of harm from atmospheric tobacco smoke, we are dealing with a social

question and not a medical one. In this regard it should be noted that, since fears and phobias can lead to ill health,
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those who urge policies based on fear and not scientific facts could be making a medical problem out of a social

one. This is indeed a strange prospect to see coming from the efforts of members of the medical profession.

We are not ignoring the fact that cigarette smoke can be bothersome to many non-smokers. But we believe this

problem is best solved not by governments but by individuals, and not with more rhetoric but more common sense

and courtesy.

Of course, if anti-smoking advocates want to work for the abolition of smoking, that is their right. We only wish

they would come out from behind their second-hand smokescreen.

R.J. Reynolds Tobacco Company

EXHIBIT 2-P

Some straight talk about smoking for young people.

We're R.J. Reynolds Tobacco, and we're urging you not to smoke.

We're saying this because, throughout the world, smoking has always been an adult custom. And because today,

even among adults, smoking is controversial.

Your first reaction might be to ignore this advice. Maybe you feel we're talking to you as if you were a child. And

you probably don't think of yourself that way.

But just because you're no longer a child doesn't mean you're already an adult. And if you take up smoking just

to prove you're not a kid, you're kidding yourself.

So please don't smoke. You'll have plenty of time as an adult to decide whether smoking is right for you.

That's about as straight as we can put it.

R.J. Reynolds Tobacco Company

EXHIBIT 2-Q

Workplace smoking restrictions:

A trend that never was.

Reports in the news media may have given you the impression that restrictive corporate smoking policies are the

wave of the future.

But, when the facts are analyzed, the wave shrinks to just a ripple.

Today, most of corporate America continues to rely on the common sense and common courtesy of employees

not on formal policy to resolve differences arising out of smoking in the workplace.
In the Matter of R.J. REYNOLDS TOBACCO COMPANY,..., 1988 WL 490114 (1988)

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This is the key finding of a major new survey of America's leading companies. The survey, commissioned by the

Tobacco Institute and completed early in 1985, was conducted by the Human Resources Policy Corporation of

Los Angeles among the Fortune 1000 service and industrial companies and Inc. magazine's 100 fastest-growing

companies.

*33 Only about one-third of the responding companies said they had any official smoking guidelines in effect.

Furthermore, the reasons most frequently given centered around common-sense situations where workers dealt

with hazardous substances, sensitive equipment or food. And almost half of these policies had been in effect for

over five years.

Two-thirds of the companies reported they prefer to encourage individual workers to settle smoking issues with

mutual respect for each other's legitimate rights and feelings.

We at R.J. Reynolds think this is not just common sense, but good business. Because it also gives managers the

flexibility they need to make decisions in the best interest of the company as a whole.

That's the way it's worked in the past. And we think it's the best blueprint for the future.

R.J. Reynolds Tobacco Company

EXHIBIT 2-R

Workplace smoking restrictions:

A trend that never was.

Reports in the news media may have given you the impression that restrictive corporate smoking policies are the

wave of the future.

But, when the facts are analyzed, the wave shrinks to just a ripple.

Today, most of corporate America continues to rely on the common sense and common courtesy of employees

not on formal policy to resolve differences arising out of smoking in the workplace.

This is the key finding of a major new survey of America's leading companies. The survey, commissioned by the

Tobacco Institute and completed early in 1985, was conducted by the Human Resources Policy Corporation of Los

Angeles among the top 1000 service and industrial companies ranked by Fortune magazine and Inc. magazine's

100 fastest-growing companies.

Only about one-third of the responding companies said they had any official smoking guidelines in effect.

Furthermore, the reasons most frequently given centered around common-sense situations where workers dealt

with hazardous substances, sensitive equipment or food. And almost half of these policies had been in effect for

over five years.

Two-thirds of the companies reported they prefer to encourage individual workers to settle smoking issues with

mutual respect for each other's legitimate rights and feelings.

We at R.J. Reynolds think this is not just common sense, but good business. Because it also gives managers the

flexibility they need to make decisions in the best interest of the company as a whole.
In the Matter of R.J. REYNOLDS TOBACCO COMPANY,..., 1988 WL 490114 (1988)

 © 2014 Thomson Reuters. No claim to original U.S. Government Works. 34

That's the way it's worked in the past. And we think it's the best blueprint for the future.

R.J. Reynolds Tobacco Company

FTC

Footnotes

1 The motion also sought to stay further proceedings until after the motion was decided and to dismiss on the ground

that Section 5 of the FTC Act violated the constitutional requirements of separation of powers. Motion to Dismiss, ¶

¶ 2, 3. The ALJ denied respondent's motion on the separation of powers ground (Order, dated August 4, 1986), and

the issue was not appealed. In light of the ALJ's order, which the Commission has found to be sufficient to constitute

an initial decision, an order staying the proceeding was unnecessary and beyond the authority of the ALJ to grant or

deny. Commission Order, dated August 8, 1986.

2 Reply Memorandum of Law of R.J. Reynolds Tobacco Co. in Support of its Motion to Dismiss Complaint and to Stay

Proceedings Pending Dismissal at 2-10, 22-25 (July 21, 1986).

3 Memorandum of Law in Opposition to Respondent's Motion to Dismiss Complaint and to Stay Proceedings at 5-13

(July 17, 1986).

4 Palko v. Connecticut, 302 U.S. 319, 327 (1937) .

5 Until fairly recently, commercial speech was thought to be unprotected by the First Amendment. See Valentine v.

Chrestensen, 316 U.S. 52 (1942). Beginning in the mid-1970's, the Court indicated that commercial speech was entitled

to some constitutional protection. See Bigelow v. Virginia, 421 U.S. 809 (1975); Pittsburgh Press Co. v. Pittsburgh

Comm'n on Human Relations, 413 U.S. 376 (1973). In Virginia State Board of Pharmacy v. Virginia Citizens Consumer

Council, Inc., 425 U.S. 748 (1976), the Court expressly held that commercial speech was entitled to First Amendment

protection.

6 One permitted category of content-based restriction consists of regulations that prohibit false or misleading commercial

advertising. Because of its hardier nature, requiring truthfulness and accuracy for commercial speech runs less risk

of self-censorship and, thus, there is “little need to sanction some falsehood in order to protect speech that matters.”

Virginia State Board of Pharmacy, 425 U.S. at 777-78 (Stewart, J., concurring) (citing Gertz v. Robert Welch, Inc.,

418 U.S. 323 (1974)).

7 Bolger v. Youngs Drug Products illustrates how the Supreme Court has relied upon the factors discussed infra when

the speech at issue does more than merely propose a commercial transaction, and in fact, discusses matters of important

public interest. 463 U.S. at 66- 67. In analyzing the “Plain Facts About Venereal Disease” pamphlet, the Court indicated

that the combined presence of three characteristics led it to characterize the pamphlet as commercial: (1) the speech was

a paid-for advertisement; (2) it referred to a specific product; and (3) the advertisement was motivated by economic

gain. Id. The Court stated, however, that it was not holding that each characteristic must be present in order to classify

speech as commercial. Id. at 67 n. 14.

8 The Bolger Court expressed “no opinion as to whether reference to any particular product or service is a necessary

element of commercial speech.” 463 U.S. at 67 n. 14.

9 The Supreme Court found in Friedman that a trade name is a form of advertising because after the name has been used

for some period of time, it conveys information about a certain quality of goods and services. 440 U.S. at 11.

10 Respondent contends that commercial speech includes only information about positive product characteristics and,

thus, does not encompass speech that, for example, claims that a product is less dangerous than another product or is

useful for the prevention of disease. See, e.g., Respondent's Answering Brief on Appeal at 25-26, 28-29; Abrams Tr.

at 83-85. We disagree. Claims that a product or service is less dangerous than consumers perceive it to be are likely

to be potent selling messages. Under respondent's standard, for example, any comparative cigarette tar and nicotine

claim would constitute fully protected speech because it does not relate to any positive attribute of the advertised

cigarette, but only to its (comparative) lack of harm. Compare FTC v. Brown & Williamson Tobacco Corp., 778 F.2d

35 (D.C.Cir.1985) (regulating deceptive tar claims as commercial speech).

11 The insurance industry advertisements at issue in Rutledge v. Liability Insurance Industry, 487 F.Supp. 5

(W.D .La.1979) and Quinn v. Aetna Life & Casualty Co., 616 F.2d 38 (2d Cir.1980) similarly can be distinguished.
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Those advertisements urged the public to support limits on jury awards in tort liability actions. The advertisements

did have a commercial aspect because insurance companies would benefit economically from reduced jury awards.

However, the advertisements did not attempt to sell insurance nor did they contain factual information addressed to

informed decision-making concerning consumers' purchases of insurance.

12 As noted above (supra at 4-5), under the standards applicable to motions to dismiss, the allegations of the complaint

are presumed to be true. The factual allegations concerning jurisdiction include ¶ ¶ 2 and 4 of the complaint and the

Reynolds advertisement, which is incorporated by reference as Attachment A. Similarly, whether an advertisement

makes a claim is an issue of fact. See FTC v. Colgate-Palmolive Co., 380 U.S. 374, 386 (1965); Thompson Medical

Co. v. FTC, 791 F.2d at 197. As a result, complaint ¶ ¶ 5 and 7 also contain factual allegations relating to jurisdiction.

13 The ALJ granted complaint counsel's motion for an additional 10 days in which to file a response to the motion to

dismiss. We find that 10 days is not a reasonable opportunity for discovery. Nonetheless, complaint counsel did obtain

and present an affidavit from Dr. Dennis L. McNeill. Attachment A to Complaint Counsel's Memorandum of Law in

Opposition to Respondent's Motion to Dismiss and to Stay Proceedings. Respondent has not filed a response to the

affidavit. We note simply at this stage of the proceeding that the unrebutted affidavit of Dr. McNeill is consistent with

our finding that the ALJ erred when he granted respondent's motion to dismiss.

14 Land v. Dollar, 330 U.S. 731, 735 n. 4 (1947). See also 2A J. Moore, J. Lucas & G. Grotheer, Moore's Federal Practice,

¶ 12.07[2.-1] at 12-47 (2d ed. 1987); 4 J. Moore, J. Lucas & G. Grotheer, Moore's Federal Practice ¶ 26.56[6] at 26-154

(2d ed. 1987); 5 C. Wright & A. Miller, Federal Practice and Procedure § 1350 at 549 (1969); 8 C. Wright & A. Miller,

Federal Practice and Procedure § 2009 (1970).

15 See Fed.R.Civ.P. 26(b)(1); Fed.R.Evid. 402. Although the Commission is an administrative agency which is not bound

by the Federal Rules, the Commission has held that the Rules “can provide an analytical framework for the disposition

of related issues.” Crush International, Ltd., 80 F.T.C. 1023, 1028 (1972).

16 Like respondent, the defendants in Herbert v. Lando contended that permitting such discovery would chill their First

Amendment rights. The Court disagreed, noting:

But if the claimed inhibition flows from the fear of damages liability for publishing knowing or reckless falsehoods,

those effects are precisely what New York Times and other cases have held to be consistent with the First Amendment.

Spreading false information in and of itself carries no First Amendment credentials.

441 U.S. at 171.

17 We recognize that Herbert v. Lando involved discovery of evidence relevant to proving the plaintiff's case in chief,

while the issue presented here concerns discovery of evidence relevant to proving the preliminary issue of jurisdiction.

Nonetheless, Rule 26(b)(1) clearly does not distinguish between information relevant to proving jurisdiction and

evidence relevant to proving a party's cause of action. Further, in both situations, the plaintiff bears the burden of proof,

and in both situations, failure to meet that burden requires dismissal of the proceeding.

18 The examples of relevant evidence discussed above are illustrative only and are not intended as an exclusive list of

facts that may be relevant to the jurisdictional issue raised in this proceeding.

1 The Comprehensive Smoking Education Act, 15 U.S.C. §§ 1331 et seq., requires four health warnings to be affixed

on a rotational basis to each pack of cigarettes and contained on a rotational basis in all cigarette advertising. The four

warnings are:

SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May

Complicate Pregnancy.

SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.

SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth,

And Low Birth Weight.

SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.

2 This piece was one of a series introduced by RJR to discuss various smoking issues. RJR ceased the entire campaign

when the complaint was issued. Abrams Aff. ¶ ¶ 6-8. The other communications are attached.

3 The majority states at page 9: “The Commission considers it premature, particularly in the absence of a full record, to

say which characteristics will be determinative in deciding whether the Reynolds advertisement constitutes commercial

speech.” Later, at page 17, the opinion says: “We emphasize, however, that we have not concluded that presentation of

extrinsic evidence is necessarily required for determining whether the Reynolds advertisement is commercial speech.”

Nonetheless, the majority finds that the ALJ did not allow a “reasonable opportunity for discovery” page 19, n. 14,

and provides a list of the evidence that “may be relevant.” Pages 20-21. The majority does not, however, suggest that

resolution of the jurisdictional question must await resolution of the deception issues.
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4 The Commission majority continually refers to the RJR communication as an “advertisement,” a characterization that

may, by itself, cause the majority to conclude that the RJR communication is commercial speech.

5 The Commission has alleged, however, that RJR misrepresented the purpose of the study.

6 Multiple Risk Factor Intervention Trial, 248 J.A.M.A. 1465 (1982).

7 The Commission has alleged that this analysis falsely or misleadingly represents that “[a] major government study

about smoking and coronary heart disease (the MR FIT study) provides credible scientific evidence that smoking is

not as hazardous as the public or the reader has been led to believe” and “[t]he MR FIT study, a major government

study, tends to refute the theory that smoking causes coronary heart disease.”

8 Initial Decision at 14. The Administrative Law Judge also allowed the parties to introduce evidence (affidavits were,

in fact, submitted and received) and heard oral argument on the jurisdictional issue. Id. at 1, 15 n. 18, 16. In addition,

at oral argument before the Administrative Law Judge complaint counsel agreed that Judge Hyun could decide the

jurisdictional question on the basis of the record before him.

9 Initial Decision at 7. Order of Administrative Law Judge Montgomery K. Hyun.

10 See also Pittsburgh Press Co. v. Pittsburgh Commission on Human Relations, 413 U.S. 376, 391 (1973), rehearing

denied, 414 U.S. 881 (1973) ( “[N]othing in our holding allows government at any level to forbid Pittsburgh Press to

publish and distribute advertisements commenting on the Ordinance, the enforcement practices of the Commission,

or the propriety of sex preferences in employment.”); Buckley v. Valeo, 424 U.S. 1, 16 (1976) ( “Yet this Court has

never suggested that the dependence of a communication on the expenditure of money operates itself to introduce a

nonspeech element or to reduce the exacting scrutiny required by the First Amendment.”)

11 Police Department of Chicago v. Mosely, 408 U.S. 92, 95 (1972). See also Consolidated Edison Co. v. Public Service

Comm'n, 477 U.S. 530, 536 (1980) (“But when regulation is based on the content of speech, governmental action

must be scrutinized more carefully to ensure that communication has not been prohibited ‘merely because public

officials disapprove the speaker's view's'.” quoting Niemotko v. Maryland, 340 U.S. 268, 282 (1951) (Frankfurther,

J., concurring in result).

12 Police Dept. of Chicago v. Mosely, supra, at 96.

13 Id.

14 Central Hudson Gas & Electric Corp. v. Public Service Comm'n, 477 U.S. 557, 582 (Stevens, J., concurring) (quoting

Mr. Justice Brandeis in Whitney v. California, 272 U.S. 357, 376-77).

15 Central Hudson Gas & Electric Corp. v. Public Service Comm'n, 447 U.S. 557 (1980).

16 Ohralok v. Ohio State Bar Ass'n, 436 U.S. 447, 456 (1978), rehearing denied, 439 U.S. 883 (1978).

17 Dun & Bradstreet, Inc. v. Greenmoss Builders, Inc., 472 U.S. 749, 757-61 (1985). The Court's determination that

greater breathing space is required for speech that deals with a matter of public concern is seen most clearly in libel

cases. When speech does not involve matters of public concern, injured parties can recover presumed and punitive

damages for false statements made negligently and without malice. Id. at 755. By contrast, when speech involves a

matter of public concern, only actual damages are recoverable by public figures or officials and only if the plaintiff

shows “actual malice,” that is, “knowledge of falsity or reckless disregard for the truth.” Id.

18 Ohralok v. Ohio State Bar Ass'n, 436 U.S. 447, 455-56 (1978), rehearing denied, 439 U.S. 883 (1978).

19 Young Drug Products Corp. v. Bolger, 526 F.Supp. 823 (1981) (“In this case all three types of proposed mailings

are commercial solicitations. Accordingly, this Court must consider this case ... within the framework set forth by the

Supreme Court for commercial speech cases.”) Id. at 826.

20 Id. at 66. The informational pamphlets were described as follows: “The first, entitled ‘Condoms and Human Sexuality,’

is a 12-page pamphlet describing the use, manufacture, desirability, and availability of condoms, and providing

detailed descriptions of various Trojan-brand condoms manufactured by Youngs. The second, entitled ‘Plain Talk

about Venereal Disease,’ is an eight-page pamphlet discussing at length the problem of venereal disease and the use and

advantages of condoms in aiding the prevention of venereal disease. The only identification of Youngs or its products

is at the bottom of the last page of the pamphlet, which states that the pamphlet has been contributed as a public service

by Youngs, the distributor of Trojan-brand prophylactics.” Id. at 62-63, n. 4.

21 Product characteristics such as price, weight, and composition can generally be easily verified by a manufacturer. In

this case RJR does not provide that type of product information; it discusses evidence developed by a governmentally

funded study and implicitly questions the categorical statements contained in the government's health warnings.

22 Only in a highly cerebral sense of the word could it be said that the RJR publication promotes the sale of RJR products.

RJR products are not shown in an attractive light, and consumers are not assured that smoking will not lead to heart
In the Matter of R.J. REYNOLDS TOBACCO COMPANY,..., 1988 WL 490114 (1988)

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disease. The piece tells consumers explicitly that there are “studies that show a statistical association between smoking

and [heart disease].” At best consumers are told that the case against cigarettes is not conclusive.

23 Although reference to a generic product obviously is not dispositive, it is an added factor corroborating the conclusion

that the publication is not, in the ordinary sense of the term, an advertisement. In Bolger, the commercial speech referred

to a specific brand and, nota bene, the brochures were “conceded [by Youngs] to be advertisements.” Bolger, supra,

at 66.

24 The majority opinion does not question that the publication in issue is direct comment on a public issue.

25 Complaint Counsel have suggested that RJR could frame the communication as a letter to the editor, testify before

legislative bodies, or have representatives appear on talk shows. Even if these were equally effective means for RJR to

engage in the debate of ideas, they could not constitutionally be limited to these means. As the Supreme Court stated in

Consolidated Edison, supra, at 541 n. 10, “we have consistently rejected the suggestion that a government may justify

a content-based prohibition by showing that speakers have alternative means of expression.”

26 Such a ban has been proposed. See, H.R. 1272, 100th Cong., 1st Sess. (1987) (a bill that would prohibit any “tobacco

sales promotion.”).

27 See note 1, infra.

28 Complaint, ¶ 5b.

29 As pointed out above, the Commission majority has concluded that a product manufacturer does not enjoy full First

Amendment protection for direct comment on a matter of public concern if that comment also “addresses the concerns

of a purchaser of the advertiser's product or service.” In addition, there is no hint in the Commission opinion of any other

ground under which a communication that is “characteristic of commercial speech” can receive full First Amendment

protection.

30 If this information were needed, RJR would undoubtedly stipulate to the facts. In addition, if the Commission majority

truly believes that this evidence is necessary to its decision it could simply receive it without remanding. See Chrysler

Corp. v. FTC, 561 F.2d 357, 362 (D.C.Cir .1977).

31 As the Court has noted: “Normally the purpose or motive of the speaker is not central to First Amendment protection,

but it does bear on the distinction between conduct that is ‘an associational aspect of “expression”,’ and other activity

subject to plenary regulation by government.” In re Primus, 436 U.S. 412, 438 n. 32 (citation omitted). In Primus the

conduct at issue (client solicitation by an ACLU attorney) was association for the advancement of ideas or beliefs. Id.

Thus the Court concluded that the “motive of the speaker” was relevant only because that factor determined whether

or not the expression was associational. Id. First Amendment rights of association are not present in the case before us.

Thus the majority's conclusion (at p. 12) that Primus holds that the “motive of the speaker” is relevant to determining

whether speech is commercial or fully protected is simply incorrect.

32 That might be the case if a cigarette company talked about the need for clean air and incorporated false information

about discount prices.

1988 WL 490114 (F.T.C.)

End of Document © 2014 Thomson Reuters. No claim to original U.S. Government Works.
Kiser v. Reitz, --- F.3d ---- (2014)

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2014 WL 4211193

Only the Westlaw citation is currently available.

United States Court of Appeals,

Sixth Circuit.

Russell KISER, Plaintiff–Appellant,

v.

Lili REITZ et al., Defendants–Appellees.

No. 13–3956. | Argued: May 8, 2014. | Decided and Filed: Aug. 27, 2014.

Synopsis

Background: Dentist brought § 1983 action seeking declaratory and injunctive relief against members of Ohio

State Dental Board, alleging that Board's regulations chilled his exercise of First Amendment commercial speech

rights by restricting his ability to advertise as specialist in endodontics while also practicing as general dentist.

The United States District Court for the Southern District of Ohio, Algenon L. Marbley, J., 2013 WL 4080734,

dismissed for lack of subject matter jurisdiction. Dentist appealed.

[Holding:] The Court of Appeals, Karen Nelson Moore, Circuit Judge, held that allegations of future threat of

enforcement supported injury in fact element for Article III standing.

Reversed and remanded.

Attorneys and Law Firms

ARGUED:Todd W. Newkirk, Frank R. Recker & Associates, Columbus, Ohio, for Appellant. Katherine J.

Bockbrader, Office of the Ohio Attorney General, Columbus, Ohio, for Appellees. ON BRIEF:Todd W. Newkirk,

Frank R. Recker & Associates, Columbus, Ohio, for Appellant. Katherine J. Bockbrader, Office of the Ohio

Attorney General, Columbus, Ohio, for Appellees.

Before: MOORE and ROGERS, Circuit Judges; NIXON, District Judge. *

OPINION

KAREN NELSON MOORE, Circuit Judge.

*1 Dr. Russell Kiser is trained as a general dentist and as an endodontist specializing in root canal procedures.

The Ohio State Dental Board (the “Board”), of which the Defendants are members, promulgated regulations that

restrict his ability to advertise as a specialist in endodontics while also practicing as a general dentist. Kiser asserts

that the regulations are unconstitutional because they chill his exercise of his First Amendment commercial speech

rights. On this appeal, we must determine whether Kiser has adequately demonstrated that he has standing to bring

his claim under the Supreme Court's recent opinion in Susan B. Anthony List v. Driehaus, –––U.S. ––––, 134 S.Ct.

2334, 189 L.Ed.2d 246 (2014). Because Kiser has alleged facts demonstrating that he faces a credible threat that

the Board's advertising regulations will be enforced against him in the future, we conclude that he has standing to

assert his pre-enforcement challenge to the regulations. Accordingly, we REVERSE the district court's dismissal

of Kiser's complaint for lack of subject-matter jurisdiction and REMAND for further proceedings.
Kiser v. Reitz, --- F.3d ---- (2014)

 © 2014 Thomson Reuters. No claim to original U.S. Government Works. 2

I. BACKGROUND

Dr. Russell Kiser is a licensed dentist practicing in Mansfield, Ohio. R. 2 (Compl. ¶ 19) (Page ID # 9). He is

thus subject to the regulation of the Ohio State Dental Board, which is authorized by statute to regulate the dental

profession in Ohio by promulgating rules, investigating violations of the rules, and administering discipline. Ohio

Rev.Code §§ 4715.02 and 4715.03. One regulation promulgated by the Board relates to dentists' advertising: it

provides that if a dentist chooses to advertise as a “specialist” in a recognized field, he may not practice or advertise

services outside the scope of that specialty. Ohio Admin. Code §§ 4715–5–04, 4715–13–05. Kiser completed an

accredited post-doctoral program in endodontics and he is a Diplomate of the American Board of Endodontics.

He accordingly may be recognized as a “specialist” in endodontics pursuant to Ohio Administrative Code § 4715–

5–04(B)(3) and (4). R. 2 (Compl. ¶ 20) (Page ID # 10).

Kiser opted to advertise himself as a specialist in endodontics, but he also continued to perform general dentistry

services. On August 17, 2009, the Board issued a written warning to Kiser for practicing “outside the scope” of his

declared specialty in endodontics, in violation of Ohio Administrative Code § 4715–5–04(B)(2). Id. ¶ 22 (Page

ID # 10–11); R. 8–1 (Warning Ltr.) (Page ID # 88–89). In relevant part, the letter stated as follows:

The Ohio State Dental Board (Board) recently concluded an investigation regarding the treatment rendered by

you to a particular patient. Based on information received during the course of the investigation, and information

that the Board had received previous thereto, concerns have arisen regarding the scope of your practice as an

endodontist.

...

[A]s a specialist, one can only advertise services associated with the specialty declared.

*2 ...

You have limited your license to the specialty of endodontics. Although you are qualified to perform procedures

outside the scope of endodontics, you are NOT permitted to perform procedures that are not part of the specialty

training of an ADA [American Dental Association] accredited program in endodontics.

Therefore, if you wish to continue to declare yourself as a specialist in endodontics, you must advertise

accordingly, and limit your practice per the ADA's definition. If you would prefer to practice in areas outside

the scope of endodontics, you may do so by no longer holding yourself out as a specialist in endodontics. You

can be a general dentist, and then advertise and perform specialty services you are qualified to perform, so long

as you also state you are a general dentist.

R. 8–1 (Warning Ltr.) (Page ID # 88–89). The Board did not take any further action at that time.

In May 2012, Kiser requested that the Board approve proposed signage for his office, which included the terms

“endodontist” and “general dentist.” R. 2 (Compl. ¶ 23) (Page ID # 11). The Board neither approved nor rejected

Kiser's proposed signage. Instead, on May 24, 2012, the Board sent Kiser a second letter recommending that he

consult legal counsel. Id. Enclosed with the letter were a copy of the regulations at issue and a copy of the first

warning letter. Id.

Kiser filed a complaint in the United States District Court for the Southern District of Ohio pursuant to 42

U.S.C. § 1983 alleging that the provisions of the Ohio Administrative Code regulating dentists' advertising

unconstitutionally restrict his First Amendment rights by limiting his truthful advertisement of the full range of
Kiser v. Reitz, --- F.3d ---- (2014)

 © 2014 Thomson Reuters. No claim to original U.S. Government Works. 3

services for which he is licensed. 1 He sought injunctive and declaratory relief. On the Board's motion, the district

court dismissed Kiser's complaint for lack of subject matter jurisdiction because “the Board has not yet enforced

the regulations at issue against Dr. Kiser, [and] his claim is not ripe for adjudication.” Kiser v. Reitz, No. 2:12–cv–

574, 2013 WL 4080734, at *3 (S.D.Ohio Aug. 13, 2013). The district court explained that Kiser's challenge to the

regulations was not ripe because “[i]t is uncertain whether the Dental Board will ever initiate any formal charges

against Dr. Kiser, and if it does, there are mechanisms in place at the administrative level for Dr. Kiser to challenge

the Board's disciplinary action.” Id. at *4. Kiser timely appealed the district court's dismissal of his complaint.

II. STANDARD OF REVIEW

[1] [2] [3] [4] We review de novo a district court's grant of a motion to dismiss for lack of subject matter

jurisdiction. McCormick v. Miami Univ., 693 F.3d 654, 658 (6th Cir.2012). When considering a challenge to a

complaint based on lack of subject-matter jurisdiction, we “must take the material allegations of the [complaint]

as true and construe[ ] [them] in the light most favorable to the nonmoving party.” United States v. Ritchie, 15

F.3d 592, 598 (6th Cir.1994). It is the plaintiff's burden, however, to prove that this court has jurisdiction over his

claim, Rogers v. Stratton Indus., Inc., 798 F.2d 913, 915 (6th Cir.1986), and that the complaint contains sufficient

factual matter to state a claim for relief that is plausible on its face, see Ashcroft v. Iqbal, 556 U.S. 662, 678,

129 S.Ct. 1937, 173 L.Ed.2d 868 (2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555–57, 127 S.Ct. 1955, 167

L.Ed.2d 929 (2007).

III. STANDING

*3 [5] [6] [7] [8] [9] The jurisdiction of federal courts is limited by Article III of the Constitution to

“Cases” and “Controversies.” U.S. Const. art. III, § 2. The standing doctrine delineates the boundary between

justiciable cases and controversies and those disputes that are not appropriately resolved through judicial process.

Although “the core component of standing is an essential and unchanging part of the case-or-controversy

requirement of Article III,” the Supreme Court has recognized that “some of [the standing doctrine's] elements

express merely prudential considerations that are part of judicial self-government.” Lujan v. Defenders of Wildlife,

504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). The ripeness doctrine is one of several justiciability

doctrines “drawn both from Article III limitations on judicial power and from prudential reasons for refusing to

exercise jurisdiction.” Reno v. Catholic Soc. Servs., Inc., 509 U.S. 43, 57 n. 18, 113 S.Ct. 2485, 125 L.Ed.2d

38 (1993). The “basic rationale” of ripeness doctrine “is to prevent the courts, through avoidance of premature

adjudication, from entangling themselves in abstract disagreements ... and also to protect ... from judicial

interference until a[ ] ... decision has been formalized and its effects felt in a concrete way by the challenging

parties.” Abbott Labs. v. Gardner, 387 U.S. 136, 148–49, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967). In addition, “[a]

claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated, or

indeed may not occur at all.” Texas v. United States, 523 U.S. 296, 300, 118 S.Ct. 1257, 140 L.Ed.2d 406 (1998)

(internal quotation marks omitted).

[10] Although the ripeness doctrine traditionally incorporates both constitutional and prudential elements, the

Supreme Court has recently suggested that prudential justiciability doctrines are “in some tension with ... the

principle that a federal court's obligation to hear and decide cases within its jurisdiction is virtually unflagging.”

Lexmark Int'l, Inc. v. Static Control Components, Inc., ––– U.S. ––––, 134 S.Ct. 1377, 1386, 188 L.Ed.2d 392

(2014) (internal quotation marks omitted). Thus, the Supreme Court has cast into some doubt “the continuing

vitality” of the long-established prudential aspects of the ripeness doctrine, specifically the aspects that concern

hardship to the parties and fitness of the dispute for resolution. Susan B. Anthony List v. Driehaus, ––– U.S. ––––,

134 S.Ct. 2334, 2346–47, 189 L.Ed.2d 246 (2014). Instead, the Court addressed the constitutional component of
Kiser v. Reitz, --- F.3d ---- (2014)

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ripeness in terms of standing. Id. at 2341 n. 5. Accordingly, we will address Kiser's claim, which was dismissed

as unripe by the district court, using the constitutional standing framework. 2

[11] [12] A plaintiff must demonstrate that he has standing to pursue his claim in federal court by showing

three elements: (1) that he has suffered an “injury in fact,” (2) that there is a “causal connection between the injury

and the conduct complained of,” and (3) that it is “likely, as opposed to merely speculative, that the injury will be

redressed by a favorable decision.” Lujan, 504 U.S. at 560–61, 112 S.Ct. 2130 (internal citations and quotation

marks omitted). In a pre-enforcement challenge, whether the plaintiff has standing to sue often turns upon whether

he can demonstrate an “injury in fact” before the state has actually commenced an enforcement proceeding against

him. “In the context of a free-speech overbreadth challenge like this one, [however,] a relaxed ripeness standard

applies to steer clear of the risk that the law ‘may cause others not before the court to refrain from constitutionally

protected speech or protection.’ ” Carey v. Wolnitzek, 614 F.3d 189, 196 (6th Cir.2010) (quoting Broadrick v.

Oklahoma, 413 U.S. 601, 612, 93 S.Ct. 2908, 37 L.Ed.2d 830 (1973)); see also Laird v. Tatum, 408 U.S. 1, 11, 92

S.Ct. 2318, 33 L.Ed.2d 154 (1972) (“[C]onstitutional violations may arise from the deterrent, or ‘chilling,’ effect

of governmental regulations that fall short of a direct prohibition against the exercise of First Amendment rights.”).

*4 [13] [14] [15] [16] A plaintiff suffers an “injury in fact” when his legally protected interest has

been invaded and the injury is both “concrete and particularized” and “actual or imminent, not ‘conjectural’ or

‘hypothetical.’ ” Lujan, 504 U.S. at 560, 112 S.Ct. 2130 (citations omitted). Although most federal claims assert

allegations that the plaintiff has suffered a past injury, “[a]n allegation of future injury may suffice if the threatened

injury is certainly impending, or there is a substantial risk that the harm will occur.” SBA List, 134 S.Ct. at 2341

(internal quotation marks omitted). A plaintiff satisfies this requirement when he alleges “an intention to engage

in a course of conduct arguably affected with a constitutional interest, but proscribed by a statute, and there exists

a credible threat of prosecution thereunder.” Babbitt v. United Farm Workers Nat'l Union, 442 U.S. 289, 298, 99

S.Ct. 2301, 60 L.Ed.2d 895 (1979). When a plaintiff has engaged in a course of conduct and the state has instructed

him to stop or face disciplinary action, we may infer a threat of prosecution that is neither “chimerical,” Steffel

v. Thompson, 415 U.S. 452, 459, 94 S.Ct. 1209, 39 L.Ed.2d 505 (1974) (internal quotation marks omitted), nor

“imaginary or wholly speculative,” Babbitt, 442 U.S. at 302, 99 S.Ct. 2301. Under such circumstances, a plaintiff

has adequately alleged a concrete and imminent harm sufficient to meet the “injury in fact” requirement.

[17] In the instant case, Kiser alleges that he has been harmed by the Board's “unlawful[ ] restrict[ion] [of his]

First Amendment commercial free speech rights.” R. 2 (Compl. ¶ 34) (Page ID # 14). He asserts that the Board's

threatened enforcement of its regulations has “exert[ed] a chilling effect on his attempt to advertise” because he

“would ... like to advertise that he performs [general dentistry] services, but is prohibited from doing so by the

[Board's] regulation[s].” Id. ¶¶ 23, 26 (Page ID # 11–12). Because the Board has not yet enforced its regulations

in a disciplinary action against Kiser, he cannot demonstrate past injury. However, Kiser has alleged a credible

threat of future prosecution sufficient to demonstrate that he is suffering an injury in fact.

[18] [19] First, Kiser has alleged “an intention to engage in a course of conduct arguably affected with a

constitutional interest.” Babbitt, 442 U.S. at 298, 99 S.Ct. 2301. Kiser alleged that he has advertised both general

dentistry and endodontic services in the past and that he intends to do so in the future. Although advertisements

and other commercial speech enjoy less rigorous First Amendment protection than other forms of expression, see

United States v. Edge Broadcasting Co., 509 U.S. 418, 426, 113 S.Ct. 2696, 125 L.Ed.2d 345 (1993), commercial

speech is nonetheless constitutionally protected so long as it “concerns lawful activity and is not misleading,”

Thompson v. W. States Med. Ctr., 535 U.S. 357, 367, 122 S.Ct. 1497, 152 L.Ed.2d 563 (2002). Therefore,

Kiser's intended advertisement of his general dentistry and endodontic services—both of which he is licensed and

qualified to perform—implicates a constitutional interest. See Elrod v. Burns, 427 U.S. 347, 373, 96 S.Ct. 2673,

49 L.Ed.2d 547 (1976) (concluding that First Amendment freedoms are affected when speech is “either threatened

or in fact being impaired at the time relief [is] sought”).
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*5 Second, Kiser's intended conduct is “arguably ... proscribed by” the regulations issued by the Board. Babbitt,

442 U.S. at 298, 99 S.Ct. 2301. The Board's regulations provide that a dentist may practice and advertise either

as a generalist or as a specialist; however, if the dentist chooses to “seek[ ] specialty recognition,” his practice

and advertising “must be limited exclusively to the indicated specialty area(s).” Ohio Admin. Code § 4715–5–

04(B)(2). Kiser wishes to advertise himself as a specialist in endodontics while also advertising and performing

general dentistry procedures. This is the same speech that the Board has in the past warned Kiser that it considers

a violation, “[a]nd, there is [thus] every reason to think that similar speech in the future will result in similar

proceedings.” SBA List, 134 S.Ct. at 2345. Accordingly, Kiser's intended conduct arguably violates the Board's

regulations.

[20] [21] Finally, Kiser has alleged that a credible threat of prosecution under the regulations exists. A plaintiff

asserting standing to challenge a law before it has been enforced against him must show a “credible fear” that the

state or its agents will in fact enforce the law in his case. Norton v. Ashcroft, 298 F.3d 547, 554 (6th Cir.2002). A

threat of future enforcement may be “credible” when the same conduct has drawn enforcement actions or threats

of enforcement in the past. See Steffel, 415 U.S. at 459, 94 S.Ct. 1209. Such a threat is considered especially

substantial when the administrative agency “ha[s] not disavowed enforcement if [the plaintiffs] make similar

statements in the future.” SBA List, 134 S.Ct. at 2345; see also Holder v. Humanitarian Law Project, 561 U.S.

1, 16, 130 S.Ct. 2705, 177 L.Ed.2d 355 (2010). Moreover, the threat need not stem from a criminal action:

“[A]dministrative action, like arrest or prosecution, may give rise to harm sufficient to justify pre-enforcement

review.” SBA List, 134 S.Ct. at 2345 (noting that the threat of administrative proceedings was “a substantial one”

but declining to “decide whether that threat standing alone gives rise to an Article III injury”); see also Ohio

Civil Rights Comm'n v. Dayton Christian Schs., Inc., 477 U.S. 619, 625–26 n. 1, 106 S.Ct. 2718, 91 L.Ed.2d 512

(1986) (“If a reasonable threat of prosecution creates a ripe controversy, we fail to see how the actual filing of the

administrative action threatening sanctions in this case does not.”).

Here, Kiser has alleged that the Board has in the past threatened to enforce the regulations against him when he

advertised or practiced general dentistry services in addition to endodontic specialty services. On one occasion,

the Board sent a letter to Kiser explaining that it had investigated his practice and determined that his advertising

or services were “outside the scope” of his specialty, and thus in violation of the regulations. R. 2 (Compl. ¶¶

22–23) (Page ID # 10–11); R. 8–1 (Warning Ltr.) (Page ID # 88–89). On a second occasion, after Kiser sought

approval of proposed signage for his office, the Board reiterated its warning that Kiser was advertising beyond

the scope of his specialty, and recommended that Kiser seek the advice of counsel. R. 2 (Compl. ¶ 23) (Page ID #

11). Although these letters did not commence an official enforcement action, they may fairly be read to threaten

implicitly enforcement of the regulations if Kiser persisted in practicing or advertising outside the scope of his

specialty. Moreover, the Board has not represented that it will decline to enforce the regulations against Kiser

should he continue to advertise as both an endodontist and a general dentist. Thus, the Board's warning regarding

Kiser's past advertisements and its response to the signage that he wishes to display in the future together constitute

a credible threat that Kiser will be subject to an enforcement action.

*6 Furthermore, the injury Kiser would suffer from an enforcement action is not insubstantial merely because

it is not accompanied by a threat of criminal sanctions. An administrative action carries significant consequences

for Kiser: the Board is empowered to suspend or revoke Kiser's license to practice dentistry in the State of Ohio,

see Ohio Rev.Code § 4715.03(B)(1), and thus Kiser faces a threat to his livelihood should he persist in flouting

the Board's regulations. The potential administrative sanctions are therefore serious enough on their own, absent

any potential criminal penalties, to create a constitutional injury in fact.

[22] [23] We conclude that Kiser has alleged facts demonstrating that he has suffered an injury in fact because

he faces a credible threat that the regulations will be enforced against him in violation of his First Amendment
Kiser v. Reitz, --- F.3d ---- (2014)

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right to engage in commercial speech. He has also alleged a causal connection between his injury and the

allegedly unconstitutional regulations—it is the threatened enforcement of the regulations that chills his truthful

advertisement of his services. Finally, Kiser has alleged that it is likely that his “injury will be redressed by a

favorable decision.” Lujan, 504 U.S. at 561, 112 S.Ct. 2130 (internal quotation marks omitted). If warranted, the

court may issue a declaratory judgment that the regulations are unconstitutional or it may enjoin enforcement of

the regulations against Kiser. Accordingly, Kiser's claim is ripe for adjudication, and he has standing to assert

his claim in federal court.

IV. CONCLUSION

For the foregoing reasons, we REVERSE the district court's dismissal of Kiser's complaint and REMAND for

further proceedings consistent with this opinion.

* The Honorable John T. Nixon, Senior United States District Judge for the Middle District of Tennessee, sitting by

designation.

1 Kiser made additional constitutional claims in his complaint, but he has not raised those issues on appeal. Accordingly,

we will not consider whether those claims are ripe for adjudication. Robinson v. Jones, 142 F.3d 905, 906 (6th

Cir.1998).

2 The “prudential” ripeness factors—hardship to the parties and fitness of the record for review—are also satisfied

in the instant case. Kiser will suffer continuing injury every day that he is unable to engage in constitutionally

protected commercial speech. See Elrod v. Burns, 427 U.S. 347, 373, 96 S.Ct. 2673, 49 L.Ed.2d 547 (1976) (“The

loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.”).

Moreover, we would not benefit from allowing the factual record to develop further because this case presents a purely

legal question. The regulations are not subject to refinement on a case-by-case basis: either a dentist's advertisement

conforms to the regulations or it does not. Compare Abbott Labs., 387 U.S. at 152, 87 S.Ct. 1507 (concluding that a

challenge to regulations relating to the labeling of pharmaceuticals did not need further factual development because

the regulations were “clear-cut” and not subject to further agency discretion or refinement), with Ohio Forestry Ass'n,

Inc. v. Sierra Club, 523 U.S. 726, 735, 118 S.Ct. 1665, 140 L.Ed.2d 921 (1998) (concluding that immediate judicial

review would interfere with administrative efforts to refine logging policies because the agency's regulations called for

administrative approval of site-specific proposals). Accordingly, the prudential ripeness factors do not pose a barrier

to judicial review of Kiser's claim.

End of Document © 2014 Thomson Reuters. No claim to original U.S. Government Works.
Marketquest Group, Inc. v. BIC Corp., Not Reported in F.Supp.2d (2011)

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2011 WL 5360899

Only the Westlaw citation is currently available.

United States District Court,

S.D. California.

MARKETQUEST GROUP, INC., Plaintiff,

v.

BIC CORPORATION; BIC USA, Inc.; Norwood Promotional Products, LLC; et al., Defendants.

No. 11–CV–618 JLS (WMC). | Nov. 7, 2011.

ORDER: (1) DENYING PLAINTIFF'S MOTION FOR PRELIMINARY

INJUNCTION; (2) DENYING DEFENDANTS' MOTION TO STRIKE

JANIS L. SAMMARTINO, District Judge.

*1 Presently before the Court is Plaintiff Marketquest Group, Inc.'s (Marketquest) motion for a preliminary

injunction. (ECF No. 27.) Also before the Court are Defendants BIC Corp., BIC USA, and Norwood Promotional

Products' (BIC) opposition (ECF No. 33), Marketquest's reply (ECF No. 35), and BIC's motion to strike (ECF

No. 40). The motion hearing set for November 10, 2011, is HEREBY VACATED, and the matter is taken under

submission without oral argument pursuant to Civil Local Rule 7.1(d)(1). Having considered the parties' arguments

and the law, the Court DENIES Marketquest's motion for a preliminary injunction and DENIES BIC's motion

to strike.

BACKGROUND

Plaintiff Marketquest is a California corporation engaged in the production, advertising, and sale of customizable

promotional products, including writing instruments such as pens, using the registered trademarks “ALL–IN–

ONE” and “THE WRITE CHOICE.” (FAC ¶ 10–12.) 1 According to Marketquest, in late 2010 Defendant BIC,

comprised of Connecticut and Delaware corporations, began advertising and selling products, including pens and

related products and services, using marks similar to Marketquest's. (FAC ¶ 21–25.) Specifically, BIC began using

the phrase “The Write Pen Choice” in an online advertising campaign for writing instruments, including pens, in

or around October, 2010. (FAC ¶ 23.) BIC also began advertising customizable promotional products, including

pens, in 2011 Catalogues using the phrase “All in ONE.” (FAC ¶ 24.)

1 Marketquest lists five separate registered trademarks (four for the “ALL–IN–ONE” mark, and one for “THE WRITE

CHOICE” mark; collectively, “the Infringing Marks”):

1. The mark “ALL–IN–ONE,” registered in connection with its sale of products including “writing instruments,

namely pens, pencils, markers, highlighting markers.” Registration No. 2,422,967 (registered Jan. 23, 2001).

(FAC ¶ 13, Ex. A.)

2. The mark “ALL–IN–ONE–LINE,” registered in connection with its sale of products including “writing

instruments, namely pens, pencils, markers.” Registration No. 2,426,417 (registered Feb. 6, 2001). (FAC ¶ 14,

Ex. B.)

3. The mark “ALL–IN–ONE stylized design,” registered in connection with its sale of products and services

including “writing instruments, namely pens, pencils, markers, highlighting markers” and “dissemination of

advertising matter.” Registration No. 3,153,089 (registered Oct. 10, 2006). (FAC ¶ 15, Ex. C.)
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4. The mark “THE WRITE CHOICE,” registered in connection with its sale of products including “writing

instruments, namely pens, pencils, markers, highlighting markers.” Registration No. 3,164,707 (registered Oct.

31, 2006). (FAC ¶ 16, Ex. D.)

5. The mark “ALL–IN–ONE stylized design,” registered in connection with its sale of services including

“customized imprinting of equipment, merchandise and accessories for business promotion.” Registration No.

3,718,333 (registered Dec. 1, 2009). (FAC ¶ 17, Ex. E.)

By way of relevant background, in 2009 Defendant BIC USA acquired what became Defendant Norwood

Promotional Products, LLC, a competitor in the promotional products business. (Def.'s Opp'n 2.) Norwood has

its own trademark registrations for the NORWOOD mark and logo/design. 2 (Id.) In late 2010, BIC printed a

number of NORWOOD catalogues for 2011, one of which was the “NORWOOD All in ONE” catalogue, which

“consolidated all of Norwood's available hard goods products in one catalogue.” (Def.'s Opp'n 3.) As of the date of

BIC's opposition to this motion, on October 3, 2011, BIC claims that this “NORWOOD All in ONE” catalogue is

no longer in print and is no longer being distributed. (Id.) “Norwood will be changing the name of its NORWOOD

Catalogue for 2012 and will no longer use the phrase ‘All in ONE.’ “ (Id. at 4.)

2 BIC lists two relevant registered trademarks:

1. The mark “NORWOOD,” registered in connection with “preparation of custom advertisements and custom

promotional products for others,” Registration No. 2,894,578 (registered Oct. 14, 2004). (Def.'s Opp'n 2.)

2. The mark “NORWOOD logo/design,” registered in connection with “custom imprinting for others of company

name, trade name, logo or other copy, namely, words, phrases, and decorative designs on promotional products,

namely, promotional merchandise, apparel, and corporate gifts; custom printing for others of company name,

trade name, logo or other copy, namely, words, phrases, decorative designs on advertising matter,” Registration

No. 3,575,173 (registered Feb. 17, 2009). (Def.'s Opp'n 2–3.)

On March 28, 2011, Marketquest filed this action for trademark infringement and unfair competition against

BIC. (ECF No. 1.) On May 5, 2011, Marketquest filed the operative First Amended Complaint. (ECF No. 14.)

Marketquest alleges what are essentially three causes of action: (1) trademark infringement under 15 U.S.C.

§ 1114(1) of its ALL–IN–ONE mark (Count I) and its THE WRITE CHOICE mark (Count III); (2) unfair

competition under 15 U.S.C. § 1125(a) for its ALL–IN–ONE mark (Count II) and its THE WRITE CHOICE mark

(Count IV); and (3) unfair competition in violation of Cal. Bus. & Prof.Code § 17200 (Count V). Marketquest

requests a preliminary and permanent injunction to enjoin BIC from using the Infringing Marks in any manner, to

order BIC to remove any products bearing the Infringing Marks from sale or display, and to order BIC to deliver

any such goods to the Court for destruction. (FAC 8–10.) Marketquest claims BIC's use of the Infringing Marks is

likely to confuse consumers, causing irreparable injury. (FAC ¶ 28–34.) On August 26, 2011, Marketquest moved

for a preliminary injunction. (ECF No. 27.)

LEGAL STANDARD

*2 A preliminary injunction is an equitable remedy aimed at preserving the status quo and at preventing the

occurrence of irreparable harm during the course of litigation. SeeFed.R.Civ.P. 65. The Ninth Circuit has recently

modified its preliminary injunction analysis in response to the Supreme Court's rejection of its previous standard.

Now, it is clear that “[a] plaintiff seeking a preliminary injunction must establish that he is likely to succeed on the

merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities

tips in his favor, and that an injunction is in the public interest.” Winter v. Natural Res. Def. Council, Inc. (NRDC),

555 U.S. 7, 20 (2008) (citing Munaf v. Geren, 553 U.S. 674, 689–90 (2008)); see also Am. Trucking Ass'ns, Inc.

v. City of L.A., 559 F.3d 1046, 1052 (9th Cir.2009). A preliminary injunction is an “extraordinary remedy that

may only be awarded upon a clear showing that the plaintiff is entitled to such relief.” NRDC, 555 U.S. at 22.

This “clear showing” requires the plaintiff to show more than a mere “possibility” of irreparable harm; instead, he
Marketquest Group, Inc. v. BIC Corp., Not Reported in F.Supp.2d (2011)

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must “demonstrate that irreparable injury is likely in the absence of an injunction.” Id. at 22 (emphasis in original);

American Trucking, 559 F.3d at 1052.

Federal Rule of Civil Procedure 65(d) requires that every order granting an injunction must “state the reasons why

it issued; state its terms specifically; and describe in reasonable detail—and not by referring to the complaint or

other document—the act or acts restrained or required.” This mandate for specificity ensures that those against

whom an injunction is issued receive fair and precise notice of what conduct is prohibited. See Halo Mgmt., LLC

v. Interland, Inc., 308 F.Supp.2d 1019, 1027 (N.D.Cal.2003) (citing Union Pac. R.R. v. Mower, 219 F.3d 1069,

1077 (9th Cir.2000)). 3

3 Rule 65 also requires the movant to give security in an amount that the Court considers proper to pay the costs and

damages sustained by any party found to have been wrongfully enjoined or restrained. Fed.R.Civ.P. 65(c). Marketquest

has requested the Court dispense with the security requirement or provide for a nominal bond. (Pl.'s Mem. ISO Mot.

16–17.) BIC has not requested Marketquest give security, nor has it submitted any evidence regarding its likely

damages if the Court grants Marketquest's motion for a preliminary injunction. Thus, the Court will not address the

security question here. Cf. Halo Mgmt., 308 F.Supp.2d at 1027 n. 11 (declining to consider the question of bond where

the defendant did not request it); see also Connecticut General Life Ins. Co. v. New Images of Beverly Hills, 321

F.3d 878, 882 (9th Cir.2003) (refusing to address a bond-related question on appeal where the district court was not

presented with the bond issue).

ANALYSIS

The Ninth Circuit, as noted, has elaborated a four-part test for determining whether a moving party is entitled to a

preliminary injunction. See, e.g., American Trucking, 559 F.3d at 1052. To succeed on a motion for a preliminary

injunction, the movant must show: (1) likelihood of success on the merits; (2) likelihood of irreparable harm in

the absence of a preliminary injunction; (3) that the balance of equities tips in his favor; and (4) that an injunction

is in the public interest. Id. (citing NRDC, 555 U.S. at 20.) The Court will address each aspect of this test below.

1. Likelihood of Success on the Merits

In order to establish a claim for trademark infringement and unfair competition, Marketquest must show: (1) that

it has a protectable ownership interest in the mark; and (2) that BIC's use of the mark is likely to cause consumer

confusion. 4 Network Automation, Inc. v. Advanced Sys. Concepts, Inc., 638 F.3d 1137, 1144 (9th Cir.2011) (citing

Dep't of Parks & Recreation v. Bazaar Del Mundo Inc., 448, F.3d 1118, 1124 (9th Cir.2006). “The core element of

trademark infringement is the likelihood of confusion, i.e., whether the similarity of the marks is likely to confuse

consumers about the source of the products.” E. & J. Gallo Winery v. Gallo Cattle Co., 967 F.2d 1280, 1290

(9th Cir.1992). Likelihood of confusion is determined by a fact-intensive, non-exclusive, eight-factor test. AMF

Inc. v. Sleekcraft Boats, 599 F.2d 341, 348–49 (9th Cir.1979); Surfvivor Media, Inc. v. Survivor Prods., 406 F.3d

625, 631 (9th Cir.2005).

4 Trademark infringement under Section 32 of the Lanham Act and unfair competition under both Section 43 of the

Lanham Act and California Bus. & Prof.Code § 17200 are in this sense coextensive. Cleary v. News Corp., 30 F.3d

1255, 1262–63 (9th Cir.1994) (“This Circuit has consistently held that state common law claims of unfair competition

and actions pursuant to California Business and Professions Code § 17200 are ‘substantially congruent’ to claims

made under the Lanham Act.”); Enesco Corp. v. Price/Costco Inc., 146 F.3d 1083, n. 1 (9th Cir.1998); Mattel, Inc.

v. MCA Records, Inc., 296 F.3d 894 (9th Cir.2002), cert. denied, 537 U.S. 1171 (2003) (“The likelihood of confusion

test also governs [plaintiff's] [California] state law claims of unfair competition.”) Section 32(1) of the Lanham Act

applies to federally registered marks and provides:

Any person who shall, without the consent of the registrant—
Marketquest Group, Inc. v. BIC Corp., Not Reported in F.Supp.2d (2011)

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(a) use in commerce any reproduction, counterfeit, copy, or colorable imitation of a registered mark in connection

with the sale, offering for sale, distribution, or advertising of any goods or services on or in connection with

which such use is likely to cause confusion, or to cause mistake, or to deceive; ... shall be liable in a civil action

by the registrant for the remedies hereinafter provided.

15 U.S.C. § 1114(1). Essentially the same standard is embodied in Section 43(a)(1) of the Lanham Act, which

applies to both registered and unregistered trademarks. 15 U.S.C. § 1125(a)(1).

*3 Marketquest argues that it is likely to succeed on the merits of its federal claims because BIC's use of “All in

ONE” is “likely to cause, and has, in fact, caused consumer confusion” because of its similarity to Marketquest's

ALL–IN–ONE mark. 5 (Pl.'s Mem. ISO Mot. 6.) BIC counters that Marketquest's ALL–IN–ONE marks were

obtained fraudulently or have been abandoned and are thus invalid, and also that no likelihood of confusion exists.

(Def.'s Opp'n 7–8.) Finally, BIC argues that even if a likelihood of confusion exists, its use of the phrase “All in

One” is a protected fair use. (Def.'s Opp'n 14.) The Court addresses each of these arguments in turn.

5 Marketquest's motion for a preliminary injunction focuses almost entirely on its ALL–INONE mark, referencing only

cursorily its THE WRITE CHOICE mark. (see Pl.'s Mem. ISO Mot. 5–7.) None of its arguments or evidence in support

of the instant motion pertain to BIC's use of THE WRITE CHOICE mark. Thus, the Court deems Marketquest's request

for a preliminary injunction as to THE WRITE CHOICE mark waived, and focuses entirely on the use of the ALL–

IN–ONE mark.

(A) Validity of the ALL–IN–ONE Marks

To determine whether BIC's use of “All in ONE” constitutes trademark infringement or unfair competition, the

Court must first resolve whether Marketquest has a valid, protectable trademark interest in the ALL–IN–ONE

mark. 6

6 Before entering into its analysis, the Court notes that it has “discretion to consider otherwise inadmissible evidence

in ruling on an application for temporary restraining order or preliminary injunction.” Glow Indus. v. Lopez, 252

F.Supp.2d. 962, 966 n. 1 (C.D.Cal.2002) (citing Sierra Club v. F.D.I.C., 992 F.2d 545, 551 (5th Cir.1993) (“At the

preliminary injunction stage, the procedures in the district court are less formal, and the district court may rely on

otherwise inadmissible evidence, including hearsay evidence. Thus, the district court can accept evidence in the form

of deposition transcripts and affidavits” (citations omitted)); see also Flynt Distrib. Co., Inc. v. Harvey, 734 F.2d 1389,

1394 (9th Cir.1984) (“The Harveys argue that Flynt's evidence is hearsay. The urgency of obtaining a preliminary

injunction necessitates a prompt determination and makes it difficult to obtain affidavits from persons who would

be competent to testify at trial. The trial court may give even inadmissible evidence some weight, when to do so

serves the purpose of preventing irreparable harm before trial”); see also Mattel, Inc. v. MCA Records, Inc., 1998 WL

422641, * 1 (C.D.Cal. Feb. 18, 1998) (denying both parties' motions to strike declarations because “strict evidentiary

rules” do not apply at the preliminary injunction phase (citations omitted)). For these reasons, BIC's motion to strike

Marketquest's evidence in support of its motion for preliminary injunction (ECF No. 40) IS DENIED.

Marketquest's registration of the four ALL–IN–ONE marks on the Principal Register in the Patent and Trademark

Office (PTO) constitutes prima facie evidence of the validity of each registered mark and of Marketquest's

exclusive right to use the marks on the goods and services specified in the registration. See 15 U.S.C. §§ 1057(b);

1115(a). Further, both parties agree that two of the four ALLIN–ONE registrations have achieved “incontestable”

status, having been in continuous use for five consecutive years subsequent to the date of registration. 15 U.S.C.

§ 1065; (see also Pl.'s Mem. ISO Mot. 8; Def.'s Opp'n 5.) To the extent that the right to use a registered mark

has become incontestable under Section 1065, “the registration serves as conclusive evidence of the validity of

the registered mark and of the registration of the mark, of the registrant's ownership of the mark, and of the

registrant's exclusive right to use the registered mark in commerce.” 15 U.S.C. § 1115(a). However, even marks

with incontestable status remain subject to the defenses set forth in Section 1115(b).
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BIC claims all four of Marketquest's ALL–IN–ONE registrations were procured fraudulently or have been

abandoned, and are thus invalid under Section 1115(b). (Def.'s Opp'n 7.) Specifically, Section 1115(b)(1) provides

the defense “[t]hat the registration or the incontestable right to use the mark was obtained fraudulently,” and

Section 1115(b)(2) provides the defense “[t]hat the mark has been abandoned by the registrant.” The Court

examines both of these asserted defenses.

(i) Fraudulent Procurement of Mark

A trademark registration, even if incontestable, is invalid if it was fraudulently obtained. See 15 U.S.C. § 1115(b)

(1). “Fraud in procuring a trademark registration or renewal occurs when an applicant knowingly makes false,

material representations of fact in connection with his application.” In re Bose Corp., 91 U.S.P.Q.2d 1938, 1939

(Fed.Cir.2009). A party seeking cancellation of a mark due to fraud bears a heavy burden. The party must identify

a deliberate attempt by the registrant to mislead the PTO, and must show that misstatements were made with

respect to material fact. Halo Mgmt., 308 F.Supp.2d at 1031 (citing Woodstock's Enter., Inc. v. Woodstocks' Enter.,

Inc., 43 U.S.P.Q .2d 1440 (T.T.A.B.1997) (“Fraud in a trademark cancellation is something that must be ‘proved

to the hilt’ ....”).

*4 Here, BIC provides very little evidence to support its theory that Marketquest's ALL–IN–ONE marks were

fraudulently procured, especially in the face of such a heavy burden. BIC merely states that there is “a serious

question” as to whether the registrations were obtained fraudulently. (Def.'s Opp'n 7.) As its one example, BIC

points to Marketquest's submission to the PTO of specimens of use that BIC states, “on information and belief,

appear to be computer renderings of products that Plaintiff never intended to sell in commerce.” (Def.'s Opp'n

7–8.) In other words, BIC objects that Marketquest provided the PTO with mock-ups of its products bearing the

ALL–IN–ONE design/logo, when in fact Marketquest never intended to sell its products bearing its own logo;

rather, it intended to sell and in fact did sell versions of these products customized with the marks of clients. (Id.

at 8; Ex. 14.) However, BIC does not explain how these catalogues fail to constitute use in commerce of the logo

in conjunction with the sale of goods.

The Lanham Act defines “use in commerce” as “the bona fide use of a mark in the ordinary course of trade.” 15

U.S.C. § 1127. BIC has not shown that failure to actually sell pens and other items with the ALL–IN–ONE logo

imprinted exactly as depicted in its advertisements necessarily means Marketquest did not use the mark in the

ordinary course of trade. A trademark need not “appear in any particular position on the goods.” In re Morganroth,

208 U.S.P .Q. 284, 288 (T.T.A.B.1980). Instead, the key to the use in commerce inquiry is whether Marketquest

used the mark as a trademark, to identify the source of its goods or services. Id.

Through its extensive use of the mark on its internet website and catalogues to identify its customizable product

lines, Marketquest is likely to succeed in establishing it has used the mark in commerce sufficiently extensively to

merit some manner of trademark protection. Further, Marketquest has provided evidence that at least some of its

customizable products, such as pens and luggage tags, were in fact sold with the ALL–IN–ONE mark embossed

on them, in addition to the customer's imprinted mark. (Pl.'s Reply 2; Pl.'s Mem. ISO Mot, Ex. 5.) Thus, BIC

has failed to provide the Court with a sufficient basis to find Marketquest did not use its ALL–IN–ONE mark in

commerce as a designation of source. As a result, the Court finds BIC has not satisfied its heavy burden to identify

a deliberate attempt by Marketquest to mislead the PTO, nor has it identified a material misstatement required

for a finding of fraudulent procurement.

(ii) Abandonment

Under the Lanham Act, a mark may be deemed “abandoned” in one of two situations: (1) “[w]hen its use has been

discontinued with intent not to resume such use,” and (2) “[w]hen any course of conduct of the owner, including
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acts of omission as well as commission, causes the mark to become the generic name for the goods or services on

or in connection with which it is used or otherwise to lose its significance as a mark.” 15 U.S.C. § 1127.

*5 BIC's argument that the ALL–IN–ONE marks were abandoned relies upon the same unsupported reasoning as

its argument that the marks were fraudulently procured. BIC asserts that Marketquest “may very well use the ALL

IN ONE marks as its trade name or service mark, but no longer in association with its physical products.” (Def.'s

Opp'n 8.) However, BIC provides no proof of this contention. Further, even if the Court takes as true BIC's

statement that Marketquest no longer imprints its mark on its customized goods, BIC still does not provide support

for the proposition that Marketquest's extensive use of the mark in advertising its customizable products fails to

constitute use in commerce for the purposes of the Lanham Act.

For these reasons, the Court concludes Marketquest is likely to succeed in showing it has valid, protectable rights

in the ALL–IN–ONE marks.

(B) Likelihood of Confusion

Next, the Court turns to the issue of customer confusion. As previously noted, the Ninth Circuit has used an

eight-factor test to analyze the likelihood of confusion in trademark cases, building on the rubric first elaborated

in Sleekcraft, 599 F.2d 341 (9th Cir.1979). The eight factors are: (1) strength of the mark, (2) proximity of the

goods, (3) similarity of the marks, (4) evidence of actual confusion, (5) marketing channels used, (6) type of

goods and degree of care likely to be exercised by the purchaser, (7) defendant's intent in selecting the mark, and

(8) likelihood of expansion of the product lines. Id. at 348–49. To determine likelihood of confusion, the Court

must apply the Sleekcraft factors in “a flexible manner, keeping in mind that the eight factors it recited are not

exhaustive, and that only some of them are relevant to determining whether confusion is likely” in any given case.

Network Automation, 638 F.3d at 1145; Sleekcraft, 599 F.2d at 348 n. 11. The Lanham Act places the burden

of proving likelihood of confusion on the party charging infringement even when relying on an incontestable

registration. KP Permanent Make–Up, Inc. v. Lasting Impression I, Inc., 543 U .S. 111, 118 (2004).

(i) Strength of the Mark

The strength of the mark, in terms of its ability to link products to their source, determines the amount of protection

from infringement that mark should be afforded. See Sleekcraft, 559 F.2d at 349; Brookfield Commc'ns, Inc. v.

West Coast Entm't Corp., 174 F.3d 1036, 1058 (9th Cir.1999) (“The stronger a mark—meaning the more likely

it is to be remembered and associated in the public mind with the mark's owner—the greater the protection it is

accorded by the trademark laws.”)

In determining the strength of the mark, courts may look to two relevant measurements: conceptual strength and

commercial strength. Network Automation, 638 F.3d at 1149. A mark's conceptual strength depends largely on the

obviousness of the connection between the mark and the goods or services to which it refers. Fortune Dynamic,

Inc. v. Victoria's Secret Stores Brand, 618 F.3d 1025, 1032 (9th Cir.2010). Marks may be classified according to

a spectrum of five categories originally formulated by Judge Friendly, ranging from weakest to strongest: generic,

descriptive, suggestive, arbitrary, or fanciful. Id. The other relevant measurement, commercial strength, is based

on “actual marketplace recognition, and thus advertising expenditures can transform a suggestive mark into a

strong mark.” Network Automation, 638 F .3d at 1149 (quotations omitted).

*6 Conceptual strength attempts to quantify the inherent distinctiveness of the mark. At one end of the spectrum,

“generic marks refer to the genus of which the particular product is a species, such as ‘bread’ or ‘door,’ and are

not registerable as trademarks.” Fortune Dynamic, 618 F.3d at 1033 (quotations omitted). At the other end of the

spectrum are arbitrary marks, “actual words with no connection to the product—such as Apple computers and

Camel cigarettes,” and fanciful marks, “made-up words with no discernable meaning—such as Kodak film and
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Sony electronics that are inherently distinctive and therefore receive maximum trademark protection.” Id. In the

middle are descriptive and suggestive marks. Descriptive marks “tell [ ] something about the product; [they] will

be protected only when secondary meaning is shown.” Sleekcraft, 599 F.2d at 349. Suggestive marks, one step

further along the spectrum of conceptual strength, “subtly connote something about the products. Although less

distinctive than an arbitrary or fanciful mark and therefore a comparatively weak mark, a suggestive mark will

be protected without proof of secondary meaning.” Id. In the conceptual strength inquiry, registration of the mark

“adds something on the scales,” but is not determinative. Zobmondo Entertainment, LLC v. Falls Media, LLC,

602 F.3d 1108, 1115 (9th Cir.2010).

In terms of conceptual strength, BIC correctly points out that the incontestable status of two of the ALL–IN–ONE

marks does not, alone, establish a strong mark. Miss World (UK), Ltd. v. Mrs. America Pageants, Inc., 856 F.2d

1445, 1449 (9th Cir.1988); (see also Def.'s Opp'n 9.) BIC argues that the ALL–IN–ONE mark is a descriptive

term that is weak and should merit only limited trademark protection. (Def.'s Opp'n 9–10.) BIC frames the ALL–

IN–ONE mark as a description of Marketquest's services “as a one-stop source for a variety of customizable

products.” (Def.'s Opp'n 10.)

Although it is true that incontestable status does not determine whether a mark is strong or weak, incontestable

marks are conclusively presumed to have secondary meaning. Miss World, 856 F.2d at 1448 n. 4; 15 U.S.C.

§ 1115(b). Further, Marketquest persuasively argues that the ALL–IN–ONE mark is at least suggestive, rather

than descriptive, and as such is inherently distinctive. (Pl .'s Reply 4.) Marketquest contends that “[n]othing in

the phrase ALL IN ONE immediately conveys knowledge to a consumer that [Marketquest] offers customized

imprinting services on the business promotion merchandise it supplies to wholesale distributors.” (Id.) Instead,

Marketquest argues that “ALL IN ONE suggests or connotes, rather than describes, a characteristic of its services

and requires consumer imagination to determine what those services are.” (Id.)

In determining the conceptual strength of a mark, the Court may be aided by the “imagination test” and the “need

test.” Miss World, 856 F.2d at 1449. The imagination test asks “how much imagination a consumer must use to

associate a given mark with the goods or services it identifies.” Id. Essentially, the more imagination required to

make the association, the stronger the mark. The need test approaches the question “from the opposite end.” Id.

It asks “to what extent a mark is actually needed by competitors to identify their goods or services.” Id. If “the

message conveyed by the mark about the goods or services is so direct and clear that competing sellers would be

likely to [need to] use the term in describing or advertising their goods [or services], then this indicates the mark

is descriptive.” Id. There is an inverse relationship between the imagination test and the need test; as the amount

of imagination required increases, the need decreases. Id.

*7 Here, the Court agrees with Marketquest that ALL–IN–ONE is at least a suggestive mark because it “requires

a mental leap from the mark to the product,” and as a registered trademark it is inherently distinctive. Brookfield,

174 F.3d at 1058; see also Network Automation, 638 F.3d at 1150. Categorizing trademarks is “necessarily an

imperfect science. Far from being neatly distinct and discrete, trademark categories often blur at the edges and

merge together.” Fortune Dynamic, 618 F.3d at 1033. However, here the mark's need aspect is plainly quite low.

In describing a company that sells customizable business promotion merchandise, the phrase “all in one” is not

needed. Correspondingly, the mark's imagination aspect is high. The Court could imagine a connection between

the phrase “all in one” and a service, like Marketquest's, that offers merchandise and advertising combined—a

useful item and an advertisement, all in one product, perhaps—but this connection is far from obvious, nor was it

supplied by either party. While BIC is correct that the phrase “all in one” comes closest to describing the “one-stop

source” aspect of Marketquest's service, it does not explain how the phrase in any way describes customizable

business promotion merchandise, which is in essence the heart of Marketquest's service.
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The Court's determination that the ALL–IN–ONE mark is inherently distinctive when applied to customizable

promotional merchandise may not end the inquiry into the strength of the mark. Network Automation, 638 F.3d

at 1150. As stated above, commercial strength and the sophistication of the consumer may also play a role. See

id. However, the Court cannot discern from the proffered evidence a basis to adequately determine commercial

strength here. Further, as an evidence-intensive inquiry, consideration of commercial strength is unnecessary at

the preliminary injunction stage. Id. Therefore, the Court finds that this factor weighs in favor of Marketquest.

(ii) Proximity of the Goods

The more closely related the goods, the higher the danger that the consumer public will “mistakenly assume there

is an association between the producers of the related goods, though no such association exists.” Sleekcraft, 599

F.2d at 350. In determining the relatedness of goods, courts consider: (1) whether the goods are complementary;

(2) whether the products are sold to the same class of purchasers; and (3) whether the goods are similar in use

and function. Id.

Here, BIC acknowledges that the goods and services at issue are similar. (Def.'s Opp'n 10.) Both parties sell

customizable promotional merchandise such as pens, USB flash drives, computer peripherals, and other officerelated products. (Pl.'s Mem. ISO Mot. 10.) Because the products at issue here are virtually interchangeable,

this factor “may be helpful, but it must be considered in conjunction with the labeling and appearance of the

advertisements and the degree of care exercised by the consumers.” Network Automation, 638 F.3d at 1150;

see also Playboy Enters., Inc. v. Netscape Commc'ns Corp., 354 F.3d 1020, 1035 (9th Cir.2004) (Berzon, J.,

concurring) (emphasizing that the proximity of the goods becomes less important if advertisements are clearly

labeled or consumers exercise a high degree of care, because rather than being confused, the consumer would

merely be confronted with choices among similar products.)

*8 Thus, although the Court finds that this factor decidedly weighs in favor of Marketquest, the Court should

not view this factor in isolation, and must consider whether the parties' status as direct competitors would actually

lead to a likelihood of confusion in light of the following factors.

(iii) Similarity of the Marks

This is an important factor in the current analysis because, “[w]here two marks are entirely dissimilar, there is no

likelihood of confusion.” Perfumebay.com Inc. v. eBay, Inc., 506 F.3d 1165, 1174 (9th Cir.2007). The similarity

of the marks used by both parties is measured in terms of appearance, sound, and meaning. Sleekcraft, 559 F.2d

at 351. Each of these aspects should be considered as they are encountered by consumers in the market for that

good or service. Id.

Standing alone the words used are identical in all respects. Marketquest uses the phrase and logo “ALL–IN–

ONE” or “All in One” to mark its catalogues and products, while BIC uses the phrase “All in ONE” on its 2011

NORWOOD Catalogue. (See Pl.'s Reply Appx. A.) Aside from slight variations in capitalization and punctuation,

the words are the same.

BIC emphasizes that the words appear differently on the two companies' catalogues. (Def.'s Opp'n 11.) The Court

agrees that the font and graphical appearance of the phrase as used by the two parties is distinguishable. The ALL–

IN–ONE logo/design used by Marketquest contains distinctive colors and graphics, consisting of a red slanted

box with white outlined lettering, with the word “IN” backed by a yellow box, all encircled by a curling white

line. (See Pl.'s Mem. ISO Mot., Ex. 5.) BIC's use, on the other hand, is not graphically distinctive, consisting of

the words “All in ONE” in plain yellow or black type. (See Pl.'s Mem. ISO Mot ., Ex. 6.)
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However, Marketquest's use of its ALL–IN–ONE marks is not confined to the logo/design. For example, it also

uses the phrase as its web domain name, and apparently imprints some of its products with the words “All–In–

One” in plain type. (See Pl.'s Mem. ISO Mot., Ex. 5.) Thus, even the appearance of the mark is often similar. In

the similarity analysis, “similarities weigh more heavily than differences.” Sleekcraft, 599 F.2d at 351.

Lastly, BIC argues that its use of the NORWOOD mark wherever the phrase “All in ONE” appears on its

catalogues should weigh in its favor in the similarity analysis, as it identifies its products in the marketplace as

clearly originating from BIC, and differentiates the products in the consumer's eye. (Def.'s Opp'n 11.)

In Sleekcraft, the Ninth Circuit noted that the use of a housemark can reduce the likelihood of confusion, but

concluded that the effect was negligible where the housemark was inconspicuous and the logo often absent.

Sleekcraft, 599 F.2d at 351. Here, BIC's use of its housemark, NORWOOD, is not inconspicuous, nor is the logo

often absent. To the contrary, the NORWOOD logo appears as the largest words on the cover of the Catalogue,

with the phrase “All in ONE” appearing in slightly smaller type, below and to the side. Even on the first page of

the Catalogue, where “All in ONE” is larger than the NORWOOD mark, the NORWOOD mark appears at least

five times on the page. (Pl.'s Mem. ISO Mot. Ex. 6.)

*9 However, Courts have found that “the addition of a celebrity ‘housemark’ to an allegedly infringing mark

may heighten confusion rather than reduce it,” especially in cases where reverse confusion is alleged. Glow Indus.

v. Lopez, 252 F.Supp.2d 962, 995 (C.D.Cal.2002) (citing Americana Trading, Inc. v. Russ Berrie & Co., 966

F.2d 1284, 1288 (9th Cir.1992) (“[T]he prominence of Russ's housemark may serve to create reverse confusion

that Russ, and not Amtra, is the source of Amtra's ‘Wedding Bears.’ Russ's housemark therefore does not, as a

matter of law, render its use of ‘Wedding Bear’ non-similar to Amtra's trademark.... Indeed, use by Russ of its

housemark along with Amtra's trademark may be an aggravation and not a justification, for it is openly trading

in the name of another.”))

Marketquest argues that, as in Americana Trading, BIC's usage of the ALL–IN–ONE mark in conjunction with

its own well-known mark actually heightens the likelihood of confusion in the similarity analysis. (Pl.'s Reply 6–

7.) Marketquest further asserts that, viewing all of the 2011 NORWOOD Catalogues in context, the placement

of the phrase “All in ONE” below the NORWOOD mark, compared to the similar placement of other phrases

(trademarked brands such as Atchison, RCC Koozie, Triumph Calendars, Good Value Calendars, etc.) below the

NORWOOD mark on the cover of other catalogues, could imply the use of “All in ONE” as a mark to designate

source. (See Pl.'s Reply 6–7, Ex. 13.) Marketquest also notes that the phrase “All in ONE” appears again on the

first page of the NORWOOD Catalogue, this time at the top of the page, as the largest words on the page. (See

Pl.'s Mem. ISO Mot. Ex. 6.)

The Court agrees that such reverse confusion is possible here. However, the context Marketquest depicts for BIC's

use of the phrase does not tell the whole story. The phrase “All in ONE” appears in a different position on the

cover of that Catalogue than the other marks on the catalogues Marketquest points to, such that the covers are not

directly analagous. (See Pl.'s Reply Ex. 13.) Instead of directly below the NORWOOD mark, the phrase “All in

ONE” appears smaller, lower, and to the side. (Id.) In addition, on the first page of the NORWOOD Catalogue, in

which “All in ONE” appears in large font at the top of the page, a blurb on the side of that same page explains that

this is the “NEW! Norwood All in ONE Catalog. Our primary product resource, featuring all product lines in ONE

catalog.” (Pl.'s Mem. ISO Mot., Ex. 6.) On page 14 of what is presumably the same 2011 NORWOOD Catalogue,

text further explains the use of the phrase: “2011 Catalog: Your all-in-one product resource! The new All in ONE

Norwood Catalog includes 14 different product categories and the brands you trust, including Atchison—now

exclusive to Norwood.... All categories in ONE Flyer ...” (Id.) These descriptions may do some work in clarifying

potential consumer confusion as to whether or not NORWOOD was using the phrase “All in ONE” as a mark to

designate the source of the goods in the catalogue.
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*10 In the context of these facts, BIC's use of the NORWOOD mark may mitigate against a finding of similarity

as consumers encounter the phrase in the marketplace. BIC's marketing materials clearly explain its use of the

phrase as the title of its Catalogue, such that consumers could deduce BIC intended to use the phrase in its

descriptive sense, referring to the Catalogue's omnibus contents, not as a mark indicating the source of the products

contained therein. However, given the reverse confusion context that Marketquest alleges (see Pl.'s Reply 5 n.

13), and the extreme similarity in proximity of goods and marketing channels of both parties (see infra.), the

Court cannot conclude that BIC's addition of the NORWOOD housemark renders the parties' uses of the phrase

“All in One” completely dissimilar. See, e.g., Glow, 252 F.Supp.2d at 995 (“[I]n the absence of survey or other

evidence of consumer reaction to the products as encountered in the marketplace, [the Court declines to find that]

the addition of the ‘J.Lo’ housemark mitigates the likelihood of consumer confusion.”)

For these reasons, balancing the extreme similarity of the marks in many respects with the mitigating facts tending

to belie this similarity, the Court concludes that this factor weighs slightly in favor of Marketquest.

(iv) Evidence of Actual Confusion

“Evidence that use of the two marks has already led to confusion is persuasive proof that confusion is likely.”

Sleekcraft, 559 F.2d at 352. However, such evidence is difficult to provide, and courts often discount it as unclear

or insubstantial. Id. As a result, providing evidence of actual confusion is not necessary to a finding of likelihood of

confusion. Network Automation, 638 F.3d at 1151. At the preliminary injunction stage of litigation, such evidence

is more likely to be sparse or nonexistent. See id. Some courts have found that, because reliable evidence of actual

confusion is difficult to obtain in trademark infringement cases, any such evidence is “substantial evidence that

confusion is likely .” See, e.g., Jockey Int'l, Inc. v. Burkard, 185 U.S.P.Q. 201, 207 (S.D.Cal.1975).

Here, Marketquest has provided what is akin to anecdotal evidence of several instances of actual confusion. (Pl.'s

Mem. ISO Mot. 11; Pl.'s Reply 6.) Marketquest provides declarations from three agents who were confused by the

NORWOOD Catalogue and thought the two companies were either the same or affiliated. (Id.; Strong Decl. ¶ 4;

Smidt Decl. ¶ 4; Moreno Decl. ¶ 3.) In addition, Marketquest provides the declaration of Harris Cohen, founder and

President of Marketquest, who states that on August 11, 2011, the company received an e-mail from a distributor

who found BIC's “use of All–In–One's Mark there to be ‘odd and confusing,’ and thought that a ‘majority’ of

industry distributors who were not as experienced as him could be confused by the advertising.” (Pl.'s Mem. ISO

Mot. 11–12; Cohen Decl. ¶ 30; Ex. 9.) Marketquest also points to two instances in which BIC representatives

referred to the NORWOOD Catalogue intentionally as its “All in ONE” Catalogue at trade shows when talking

to other industry representatives. (Pl.'s Mem. ISO Mot. 12; Land Decl. ¶ 4; Cohen Decl. ¶ 29.)

*11 Although five or six instances of actual customer confusion might be enough to find substantial evidence

that confusion is likely in some circumstances, the facts here do not support such a finding. All of Marketquest's

anecdotes involve experienced industry distributors or agents, who are likely to be sophisticated consumers and

investigate any potential confusion. See, e.g., Glow, 252 F .Supp.2d at 1000 (“Here, at most, Glow, Inc. present

(sic ) de minimis evidence of actual confusion; some of it, moreover, involves ‘sophisticated’ wholesalers who

might be expected to inquire about the affiliation, if any, between the companies.”) Although it is well established

that initial interest confusion may be actionable, these few instances of alleged initial confusion are nonetheless

weak evidence of actual confusion. Brookfield, 174 F.3d at 1062–64;see also Moose Creek, Inc. v. Abercrombie &

Fitch Co., 331 F.Supp.2d 1214, 1230 n. 9 (C.D.Cal.2004), aff'd 114 Fed. Appx. 921 (9th Cir.2004). Furthermore,

the importance of this factor is diminished at the preliminary injunction stage. Network Automation, 638 F.3d at

1151. Accordingly, the Court finds this factor weighs only very slightly in Marketquest's favor.

(v) Marketing Channels Used
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“Convergent marketing channels increase the likelihood of confusion.” Network Automation, 638 F.3d at 1151.

In Sleekcraft, the two products were sold in niche marketplaces, including boat shows, specialty retail outlets, and

local and national trade magazines, using similar sales methods and price ranges. Sleekcraft, 599 F.2d at 353. This

factor becomes less important “when the marketing channel is less obscure.” Network Automation, 638 F.3d at

1151 (finding the Internet to be too broad a shared marketing channel to merit any weight in this factor.)

Here, BIC concedes that the parties occupy similar marketing channels, but instead attempts to blur the issue

by emphasizing that the marketing channels consist of sophisticated customers. (Def.'s Opp'n 13.) The Court

considers the sophistication of customers next. However sophisticated, the pool of potential customers is virtually

identical for both parties. The two companies are direct competitors, as both supply customizable promotional

merchandise. Both companies advertise their products and services via the Internet, through printed catalogues,

and at trade shows. (Pl.'s Mem. ISO Mot. 12.) Accordingly, the Court finds this factor favors Marketquest.

(vi) Type of Goods and Degree of Care Likely to be Exercised by the Purchaser

Courts look at the likelihood of confusion through the lense of the reasonably discriminating purchaser. See,

e.g., Network Automation, 638 F.3d at 1152. “When the buyer has expertise in the field, a higher standard is

proper though it will not preclude a finding that confusion is likely.” Sleekcraft, 599 F.2d at 353. When goods

are expensive, the buyer might be expected to exercise greater care, though confusion may still be likely. Id.

Thus, the Court must examine how discriminating the average buyer of customizable promotional merchandise

is likely to be.

*12 BIC argues the targeted consumers of both parties' products are sophisticated. (Def.'s Opp'n 14.) BIC cites

the fact that the minimum order of each customized item listed in Marketquest's catalogue is 250 or 300, and that

consumers seeking branded merchandise are likely to be institutions and companies rather than individuals. (Id.)

Marketquest failed to address this factor in its motion, stating that it had yet to “fully investigate this factor.” (Pl.'s

Mem. ISO Mot. 13.) Instead, Marketquest points to the previously referenced instances of actual confusion to

counter BIC's allegations of sophistication. (Pl.'s Reply 8.)

The degree of consumer care and sophistication can be proven by survey evidence, expert testimony, or inference.

See, e.g., Star Indus., Inc. v. Bacardi & Co. Ltd., 412 F.3d 373 (2d Cir.2005), cert. denied, 126 S.Ct. 1570 (2006).

Here, the parties have provided no survey evidence or expert testimony. Thus, the Court must rely on its own

inference to determine whether the reasonably discriminating purchaser of customizable promotional merchandise

should be held to a heightened standard.

The evidence currently before the Court indicates that buyers are likely to be sophisticated, institutional buyers

placing bulk orders for corporate promotional purposes. The marketing materials of both parties appear to be

aimed at institutional purchasers. However, the parties have barely addressed the factor, presenting the Court with

very little evidence from which to form a solid conclusion.

It is possible, for example, that the average customer, although institutional, is not likely to exercise a heightened

standard of care when making a purchase of 300 branded pens which will cost its company 50 cents each. (See,

e.g., Pl.'s Mem. ISO Mot. Ex. 5.) Further, customers, although institutional, may be likely to be companies whose

main business has no relation to the purchase of customized promotional products, differentiating this situation

from others in which courts have found professional consumers are likely to exercise a high degree of care. See,

e.g., Moose Creek, 331 F.Supp.2d at 1231 (“Plaintiff's customers are professional commercial clothing buyers

and they are therefore likely to be familiar with the retail clothing market, likely to exercise a high degree of care

in selecting wholesale clothing to purchase and thus unlikely to be easily confused by both parties' use of a moose

on their marks.”) In the alternative, it is possible that customers are more likely to be marketing representatives

or agents who may have a lot of specific knowledge about customizable promotional products.
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Given Marketquest's failure to contest BIC's assertion that the average customer is highly sophisticated and the

lack of evidence pertaining to this issue, the Court finds this factor weighs slightly in favor of BIC but should be

accorded little weight in the present analysis.

(vii) Defendant's Intent in Selecting the Mark

*13 “When the alleged infringer knowingly adopts a mark similar to another's, reviewing courts presume that

the defendant can accomplish his purpose: that is, that the public will be deceived.” Sleekcraft, 599 F.2d at 354.

Thus, if Marketquest can show that BIC deliberately adopted the ALLIN–ONE mark in order to obtain advantage

from Marketquest's goodwill, this may weigh heavily in favor of finding a likelihood of confusion.

Marketquest argues that bad faith is “the only reasonable explanation for Defendants' choice” of the phrase “All

in ONE” for its NORWOOD Catalogue. (Pl.'s Mem. ISO Mot. 13.) Marketquest alleges that BIC was “well aware

of All–In–One in advance” of choosing the phrase for its catalogue, and that the choice was an “attention getting

symbol.” (Pl.'s Reply 9.) To show bad faith, Marketquest alludes to several other marks it claims BIC “raided,”

including its THE WRITE CHOICE mark, which it originally claimed was infringed in the present action but has

not pursued in the instant motion. (Id.; see also FAC ¶ 16.) BIC counters that it used the phrase “in good faith

in an effort to streamline the number of catalogues Norwood would have to distribute, and to describe what the

catalogue contains.” (Def.'s Opp'n 14; Bauer Decl. ¶ 7.) In addition, BIC emphasizes that it displays the phrase

next to its NORWOOD trademark, which indicates it did not intend to deceive consumers. (Id.)

The Ninth Circuit has recently emphasized that intent should not be considered in isolation, and that, “much like

the proximity of the goods, the defendant's intent may be relevant here, but only insofar as it bolsters a finding

that the use of the trademark serves to mislead consumers rather than truthfully inform them of their choice of

products.” Network Automation, 638 F.3d at 1153. In Network Automation, the district court failed to consider

whether the defendant's intentional choice to use the plaintiff's mark was based on a bad faith intent to deceive,

or a permissible intent to compare the two products. Id. Here, BIC has not alleged its use was based on an intent

to compare. Instead, BIC asserts its use was unintentional and that it did not mean to conjure up Marketquest's

products or services in any way in the minds of consumers. (Def.'s Opp'n 14–15.)

In the absence of any evidence that BIC acted with a bad faith intent when it used the phrase “All in ONE” on

its 2011 NORWOOD Catalogue, the Court does not impute such intent based on Marketquest's circumstantial

allegations. Accordingly, this factor weighs in favor of BIC.

(viii) Likelihood of Expansion of the Product Lines

The parties agree the Court need not consider this factor here, where the product lines already entirely overlap.

(Pl.'s Mem. ISO Mot. 14; Def.'s Opp'n 14.) “Where two companies are direct competitors, this factor is

unimportant.” Network Automation, 638 F.3d at 1153; cf. Brookfield, 174 F.3d at 1060. Accordingly, the Court

finds this factor should be accorded no weight.

(ix) Sleekcraft Factors Weigh in Favor of Finding a Likelihood of Confusion

*14 The Court notes that this likelihood of confusion test is fact-intensive, and many of the factors considered

above are dependent upon factual conclusions that ultimately should be sent to trial for resolution. However,

the Court must make a preliminary decision here for the purposes of this motion. Upon weighing the Sleekcraft

factors, the Court concludes that the majority weigh in favor of finding a likelihood of confusion. Each of the first

through fifth factors weighs at least slightly in favor of Marketquest, and only the sixth and seventh factors weigh
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against. Having found some likelihood of confusion, the Court now turns to BIC's argument that the affirmative

defense of fair use should bar liability here.

(C) Fair Use

BIC argues that even if the Court finds the likelihood of confusion factors weigh in favor of Marketquest, the “fair

use” defense should shield BIC from infringement liability. (Def.'s Opp'n 15.) An affirmative defense of fair use

is available to a party who uses a descriptive word “otherwise than as a mark ... [and] fairly and in good faith only

to describe the goods or services of such party, or their geographic origin.” 15 U.S.C. § 1115(b)(4). This Section

of the Lanham Act codifies a longstanding common law principle that “[t]he use of a similar name by another to

truthfully describe his own product does not constitute a legal or moral wrong, even if its effect be to cause the

public to mistake the origin ... of the product.” William R. Warner & Co. v. Eli Lilly & Co., 265 U.S. 526, 529

(1924); Fortune Dynamic, 618 F.3d at 1039. Subjective good faith is relevant to the inquiry, but the main focus

of the analysis is on whether the use of the mark was “objectively fair.” Fortune Dynamic, 618 F.3d at 1039.

The Supreme Court recently clarified that the affirmative defense of fair use may be validly asserted even in cases

where some degree of likelihood of confusion exists. KP Permanent Make–Up, 543 U.S. at 120 (“If a plaintiff

succeeds in making out a prima facie case of trademark infringement, including the element of likelihood of

consumer confusion, the defendant may ... raise an affirmative defense to bar relief ... [including fair use].”).

However, the Ninth Circuit has explained that the degree of customer confusion remains a factor in evaluating fair

use. KP Permanent Make–Up Inc. v. Lasting Impression I, 408 F.3d 596, 609 (9th Cir.2005). Among the relevant

factors for consideration in determining the fairness of the use are “the degree of likely confusion, the strength of

the trademark, the descriptive nature of the term for the product or service being offered by [the plaintiff] and the

availability of alternate descriptive terms, the extent of the use of the term prior to the registration of the trademark,

and any differences among the times and contexts in which [the plaintiff] has used the term.” Id.

Here, although the Court has found that the phrase ALL–IN–ONE is an inherently distinctive mark that is not

merely descriptive of Marketquest's service providing customizable promotional products, it is nonetheless a

phrase commonly used by companies in general to describe the comprehensive nature of their services. The

Supreme Court has explained that the Lanham Act exhibits a certain leniency where a descriptive phrase was

selected to be a mark. Id. at 122. “If any confusion results, that is a risk the plaintiff accepted when it decided

to identify its product with a mark that uses a well known descriptive phrase.” Id. (citing Park ‘N Fly, Inc.

v. Dollar Park and Fly, Inc., 469 U.S. 189 (1985) (noting safeguards in Lanham Act to prevent commercial

monopolization of language); Car–Freshener Corp. v. S.C. Johnson & Son, Inc., 70 F.3d. 267, 269 (2d Cir.1995)

(noting importance of “protect[ing] the right of society at large to use words or images in their primary descriptive

sense”)).

*15 The question remains whether BIC's use of the phrase “All in ONE” on its 2011 NORWOOD Catalogue was

otherwise than as a mark and only to describe its goods and services. To determine whether a term is being used as

a mark, courts may look for indications that the term is being used to associate goods with a certain manufacturer.

Fortune Dynamic, 618 F.3d at 1040 (citing Sierra On–Line, Inc. v. Phoenix Software, Inc., 739 F.2d 1415, 1423

(9th Cir.1984)). Other indications of trademark use include “whether the term is used as a symbol to attract public

attention, which can be demonstrated by the lettering, type style, size and visual placement and prominence of

the challenged words, ... [and] whether the allegedly infringing user undertook precautionary measures such as

labeling or other devices designed to minimize the risk that the term will be understood in its trademark sense.”

Fortune Dynamic, 618 F.3d at 1040 (citations omitted).

Here, the Court finds BIC likely used the phrase “All in One” otherwise than as a mark and solely in its descriptive

sense, to distinguish one particular catalogue as a catch-all catalogue containing all of BIC's customizable

promotional products. The NORWOOD mark was prominently displayed wherever the words “All in One”
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appeared, and BIC also explained its use of the phrase in several places in the catalogue, such as: “Our primary

product resource, featuring all product lines in ONE catalog.” (Pl.'s Mem. ISO Mot., Ex. 6.) Although Marketquest

has offered evidence that BIC's use could be confused for an indication of source by comparison to NORWOOD's

other catalogues tailored to the sale of other trademarked items or through a few instances of documented actual

confusion, the Court finds this evidence unpersuasive.

The last factor in the fair use analysis asks whether BIC has exercised “good faith.” This inquiry is similar

to the intent factor in the likelihood of confusion analysis, focusing on whether BIC intended to capitalize on

Marketquest's good will in adopting its mark Fortune Dynamic, 618 F.3d at 1043. Marketquest offers no evidence

of malicious intent on the part of BIC, other than assertions that BIC must have known about the ALL–IN–ONE

mark and thus must have had bad faith. (Pl.'s Reply 9.) However, as above, this is not sufficient indication of bad

faith to impute malicious intent. Further, using an objective fairness standard, the explanations BIC included in

its catalogue of its use of the phrase “All in One” persuade the Court that use was likely fair. Thus, the Court finds

BIC is likely to succeed on its affirmative defense of fair use.

2. The Other Preliminary Injunction Factors

Because the Court finds BIC is likely to succeed in asserting a fair use defense, it concludes Marketquest is unlikely

to succeed on the merits of its trademark infringement case. Thus, the Court need not examine the other preliminary

injunction factors: the likelihood of irreparable harm in the absence of a preliminary injunction; the balance of

equities; and the public interest. See Network Automation, 638 F.3d at 1154 (finding that there is no need to reach

the three remaining preliminary injunction elements where there is no likelihood of confusion.) Marketquest has

fallen short of making the required showing that it is likely to succeed on the merits of its trademark infringement

action. As a result, the Court finds the relief Marketquest seeks is better left to a trial on the merits and, if successful,

an appropriately tailored permanent injunction.

CONCLUSION

*16 For the foregoing reasons, the Court DENIES Marketquest's motion for a preliminary injunction.

IT IS SO ORDERED.

Footnotes

End of Document © 2014 Thomson Reuters. No claim to original U.S. Government Works.
Pride Family Brands, Inc. v. Carl's Patio, Inc., Slip Copy (2014)

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2014 WL 347040

Only the Westlaw citation is currently available.

United States District Court,

S.D. Florida.

PRIDE FAMILY BRANDS, INC., Plaintiff,

v.

CARL'S PATIO, INC., Carl's Patio West, Inc., Woodard–Cm, Inc., and Scott Coogan, Defendants.

No. 12–21783–CIV. | Jan. 30, 2014.

Attorneys and Law Firms

Yale Lance Galanter, Galanter Law, P.A., Aventura, FL, for Plaintiff.

Andrew J. Daire, Boca Raton, FL, Oliver Alan Ruiz, Benjamin Michael Hanrahan, Malloy & Malloy, P.L. Miami,

FL, for Defendants.

ORDER GRANTING DEFENDANTS' SECOND AND FINAL MOTION FOR SUMMARY JUDGMENT

PATRICIA A. SEITZ, District Judge.

*1 THIS CAUSE comes before the Court on Defendants Woodard–CM, LLC. (“Woodard”) and Scott Coogan's

Second and Final Motion for Summary Judgment [DE 111] wherein Defendants seek summary judgment on the

remaining claims in this case. 1 Pride and Woodard are competing patio furniture manufacturers. Pride alleges

Woodard infringed its unregistered trade dress by copying the design of Pride's Coco Isles and Cabana Bay

furniture collections in a confusingly similar product line Woodard calls Jumby Bay. Pride claims that Woodard's

copying violated § 43(a) of the Lanham Act (Claim II). Pride has also asserted common law claims for Unfair

Competition (Claim III) and Unjust Enrichment (Claim IV), and a Florida statutory claim of Deceptive Acts and

Practices (Claim V). 2

1 The Court previously granted summary judgment for Defendants on Plaintiff's claim of design patent infringement

(Claim I). [DE 132].

2 Though Defendants also seek the entry of summary judgment as to Defendant Coogan on legal grounds of individual

non-liability, the merits of that argument are not reached because summary judgment is granted for both Defendants

on other grounds. Defendants also seek a finding under 15 U.S.C. § 1117 that the action qualifies as an “exceptional

case” which if granted would entitle Defendants to its attorney's fees. That issue is not reached here because an Order

to Show Cause on the imposition of sanctions is forthcoming.

Having considered the motion, Pride's opposition [DE 121], and the reply [DE 130], summary judgment must

be granted for Defendants. When the record evidence is viewed in the light most favorable to Pride, it cannot

prevail on its trade dress infringement claim for three, separately dispositive reasons. First, the record evidence

overwhelmingly shows that Pride's trade dress is functional and therefore not protectable. Second, the record

evidence fails to demonstrate that either Pride collection achieved secondary meaning. Finally, there is no evidence

that the relevant customers were likely to confuse Pride's and Woodard's collections. Because Claims III, IV,

and V are predicated on Pride alleging a viable trade dress infringement claim, summary judgment must also be

granted on those claims.
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BACKGROUND 3

3 Unless otherwise noted the facts are taken from the undisputed record evidence.

a. Business Backdrop of the Dispute

Coco Isles, Cabana Bay, and Jumby Bay are each patio furniture collections in a tropical motif. 4 Defendant Scott

Coogan designed all three collections. Coogan worked for Pride between 2004 and 2006 and joined Woodard

in 2010. Pride contends that the Jumby Bay designs “are substantially identical and confusingly similar to the

designs of the corresponding pieces of the [Coco Isles and Cabana Bay] collection[s].” [DE 6, ¶ 23]. 5

4 The collections include chairs, bar stools, sofas and love seats, dining tables, occasional tables, and ottomans.

According to Plaintiff's CEO Steven Lowsky, Cabana Bay differs from Coco Isles in that the tubing used in Cabana

Bay's frames is larger, Cabana Bay has a more nautical feel, and that Cabana Bay was intended for a different audience.

(Deposition of Steven Lowsky, DE 111–4, 196:4–8).

5

It is undisputed that Woodard brought certain pieces of Coco Isles furniture to its factory in Michigan when it fabricated

its Jumby Bay prototypes. Woodard's chief engineer Reed Stauffer testified in his deposition that Woodard brought

the Coco Isles pieces to its factory to ensure that the products Woodard was making surpassed Pride's comfort level.

(Deposition of Reed Stauffer, 130–2, 71:8–18).

For several years Pride sold the Coco Isles and Cabana Bay collections to an outdoor furniture retailer called

Carl's Patio (“Carl's”). In October or November 2011, Carl's decided to carry Woodard's Jumby Bay line and

stopped buying Coco Isles or Cabana Bay. The patio furniture business is competitive. It is commonplace for

manufacturers to involve large retailers in the design phase to ensure that new collections will sell. (Deposition

of Greg Ecoff, DE 111–12, 74:5–17). Sometime after November 2010, when Coogan joined Woodard, Woodard

approached Carl's with the prototype for its Jumby Bay collection. Carl's directed Woodard to change its designs

to add lashing and flare the chairs' armrests. Woodard made the changes. Carl's bought Jumby Bay and abandoned

Coco Isles and Cabana Bay. Pride now alleges that Defendant Coogan and Woodard conspired with Carl's to

produce a cheaper “knock off' of Coco Isles and Cabana Bay. 6

6

Plaintiff named Carl's Patio and Carl's Patio West as Defendants. The Carl's entities filed a suggestion of bankruptcy

on February 27, 2013. [DE 40, 41]. The Court stayed the case against Carl's [DE 43] and required status reports on the

bankruptcy to be filed every sixty days. Carl's filed its last report on July 1, 2013 wherein it advised the bankruptcy

case would be resolved by a global settlement which the Bankruptcy Court would review later that month. Carl's has

not filed an additional report since the one in July and no party has moved to lift the stay against Carl's.

b. The Claimed Trade Dress

*2 Trade dress is the “the total image of a product and may include features such as size, shape, color or color

combinations, textures, graphics, or even particular sales techniques.” Hyman v. Nationwide Mut. Fire Ins. Co.,

304 F.3d 1179 (11th Cir.2002). Pride claims trade dress rights in an expansive, yet vague list of elements from

the Coco Isles and Cabana Bay collections. 7 Pride marketed Coco Isles and Cabana Bay under three different

brand names-Prestige, Castelle, and Expressions. 8 However, when Carl's displayed the collections in its stores, it

displayed the pieces only with Carl's Patio hangtags and not with tags that had any brand identifier. With respect

to the color or color combinations, Pride's offerings are highly customizable. Depending on collection and piece,

retailers could choose up to seventeen different frame finishes and nineteen different fabrics. [DE 111–11].

7

In its complaint Pride alleges that its “chair design,” “leg ornamentation,” “table and chair design,” “arm wrapping,”

“paint finish,” and “fabric” are protected trade dress. [DE 6, ¶ 19]. In a response to an interrogatory Plaintiff answered

that its protected trade dress consists of “[f]abrication and design of the aluminum, including the curvature and the
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aluminum lashings as [sic] various points on the products as well as the frame finish and cushion design and color

and the overall unique product design of the collection.” [DE 111–2, ¶ 17]. Moreover, when asked in depositions

what features of the Coco Isles collection were distinctive Plaintiff's CEO Steven Lowsky responded “[i]t's got a very

tropical feeling. It's got hand lashings in nine different areas. It's got a very plush, thick cushion. It's got great comfort.

It's got a wonderful tortoise shell paint job.” [DE 111–4, 192:12–15].

8 Carl's co-founder Gary Eckoff stated in his deposition that for a few years Carl's Patio put its own brand name on

Pride's collections. [DE 111–12, pp. 89–90]. The record does not contain evidence of a consumer survey regarding

consumer's association of any Pride brand to the Pride Family Brands company. [DE 111–19, ¶ 7]. However, in his

deposition, Gary Ecoff stated that a study Carl's Patio commissioned regarding brand recognition in the patio furniture

industry generally found very little brand recognition in industry. Only one manufacturer, Brown Jordan, had achieved

recognition of over 3%, the statistical relevance threshold, and even then, Brown Jordan's recognition was only 3.5%.

[DE 111–12, pp. 88–89].

Certain design elements are common to the tropical genre. [DE 111–12, pp. 83–84]. These include the use of

brown and beige finishes, natural fabric colors, cast embellishments that resemble bamboo nodes, and lashings.

Such elements intended to evoke bamboo and rattan, materials that furniture in the tropics is traditionally made

from. (See Deposition of Paul Otowchits, DE 111–16, 82:10–22). The record evidence includes photographs of

outdoor furniture collections by Tommy Bahama [DE 111–8], Lane Venture [DE 111–3], and Lloyd Flanders

[111–10]. Many of these design elements are present in the collections of those manufacturers.

c. Relevant Market Factors

Pride's customers are furniture retailers. (Deposition of Steven Lowsky, DE 111–4, 218:4–8). Pride markets its

collections at industry-wide trade shows in Chicago in July and September. (Deposition of Gary Ecoff, DE 111–

12, 125:7–10). Like other players in the casual furniture industry, Pride displays its collection in large showrooms

it leases at the Chicago Merchandise Mart. Buyers for retailers walk through the showrooms to view a particular

manufacturer's collection and are presented with the manufacturer's marketing materials and, on request, its price

lists. Pride also markets its furniture by using sales representatives to call on retailers at their stores. Retailers are

aware that a manufacturer's representative only sells the manufacturer's products. [DE 111–4, 218:4–9].

II. SUMMARY JUDGMENT STANDARD

Summary judgment is appropriate when “the pleadings, depositions, answers to interrogatories, and admissions

on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that

the moving party is entitled to a judgment as a matter of law.” Anderson v. Liberty Lobby, Inc., All U.S. 242,

247 (1986). Once the moving party demonstrates the absence of a genuine issue of material fact, the non-moving

party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’ “ Matsushita Elec.

Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (quoting Fed.R.Civ.P.

56(e)). The Court must view the record and all factual inferences therefrom in the light most favorable to the nonmoving party and decide whether “ ‘the evidence presents a sufficient disagreement to require submission to a

jury or whether it is so one-sided that one party must prevail as a matter of law.’ ” Allen v. Tyson Foods, Inc., 121

F.3d 642, 646 (11th Cir.1997) (quoting Anderson, 477 U.S. at 251–52)).

*3 Summary Judgment must be granted for Defendants on Plaintiff's trade dress infringement claim (Claim II)

because when the record evidence is viewed in the light most favorable to Plaintiff, it does not support that there is

a disputed material issue of fact as to whether (i) Plaintiff's trade dress is non-functional and therefore protectable;

or whether (ii) Plaintiff's trade dress had acquired secondary meaning; or whether (iii) Defendant's products were

likely to cause confusion in the market as to their designation of origin. Because the remaining claims-Unfair

Competition (Claim III), Unjust Enrichment (Claim IV), and Deceptive Acts and Practices (Claim V)—are each

factually predicated on the viability of its trade dress infringement claim, summary judgment must also be granted

as to those claims.
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III. TRADE DRESS INFRINGEMENT

Plaintiff alleges that the design elements of its products constitute protected trade dress. Where a plaintiff alleges

a defendant infringed its trade dress by copying designs rather than packaging, the claim can only go forward if

the plaintiff shows the claimed design elements are nonfunctional and have secondary meaning such that they

identify the producer. Wal–Mart Stores, Inc. v. Samara Bros., 529 U.S. 205, 120 S.Ct. 1339, 146 L.Ed.2d 182

(2000). Once the plaintiff has established that its design constitutes protectable trade dress, it still must show that

customers are likely to confuse the defendant's products for their own to prevail. Dippin' Dots, Inc. v. Frosty Bites

Dist., LLC, 369 F.3d 1197, 1202 (11th Cir.2004). Each of these is a “threshold” element. Id. Therefore, Plaintiff's

inability here to show a genuine factual dispute in record evidence as to non-functionality, secondary meaning,

or market confusion means its trade dress claim fails thrice over.

a. The Claimed Elements are Functional

Because Pride does not own a registered trademark for the Coco Isles of Cabana Bay designs, pursuant to 15

U.S.C. § 1125(a)(3), it has the “burden of proving that the matter sought to be protected is not functional.” There

are two categories of functionality. Dippin' Dots, Inc., 369 F.3d at 1203. First, an element is functional if “it

is essential to the use or purpose of the article ... or affects the cost or quality of the article[.]” Qualitex Co. v.

Jacobson Prods. Co., Inc., 514 U.S. 159, 165, 115 S.Ct. 1300, 131 L.Ed.2d 248 (1995). Second, under the doctrine

of aesthetic functionality, an element is functional if its “exclusive use ... would put competitors at a significant

non-reputation-related disadvantage.” Id. As such, courts look to the whether a competitor necessarily needs to

use the claimed dress to compete in the field. See Dippin' Dots, Inc., 369 F.3d at 1204, n. 7 (“Likewise, the color,

shape, and size of dippin' dots are ‘aesthetic functions' that easily satisfy the competitive necessity test because

precluding competitors like FBD from copying any of these aspects of dippin’ dots would eliminate all competitors

in the flash-frozen ice cream market, which would be the ultimate non-reputation-related disadvantage.”). The

record evidence overwhelmingly supports that Plaintiff's trade dress is functional under the doctrine of aesthetic

functionality. 9 10

9 One of the claimed elements, a lashing that connects the leaf to the arm of the Coco Isle chair is essential to the

construction of the chair as Plaintiff's CEO even conceded and it is therefore functional under the first category. [DE

111–4, 185:11–21.]

10 Despite carrying the burden to prove its trade dress is non-functional, Plaintiff's opposition brief inexplicably ignores

that requirement. In lieu of addressing Defendant's argument that Plaintiff's trade dress is functional, Plaintiff, at

considerable length, argues that Defendants copied its designs. In so doing, Plaintiff has put the cart before the horse.

Until Plaintiff shows its trade dress is protectable, Woodard, or anyone else, would be free to copy Plaintiff's claimed

trade dress. See TraFix Devices, Inc. v. Mkt'g Displays, Inc., 532 U.S. 23, 29, 121 S.Ct. 1255, 149 L.Ed.2d 164

(2001) (“Trade dress protection must subsist with the recognition that in many instances there is no prohibition against

copying goods and products. In general, unless an intellectual property right such as a patent or copyright protects an

item, it will be subject to copying.”).

*4 The design elements Plaintiff seeks to claim as protected trade dress are common to the tropical motif. Plaintiff

claims, inter alia, that its “chair design,” “leg ornamentation,” “table and chair design,” “arm wrapping,” “paint

finish,” “fabric,” and “lashings” are protected trade dress. The tropical motif is referential of rattan and bamboo

furniture of the tropics and, among other features, includes curving, naturalistic frame forms, fabrics in natural

colors like brown and beige, and cast ornament applications meant to resemble natural features in bamboo. It is

well-documented in the record that Plaintiff is simply one of many producers of tropical furniture that currently

uses these techniques. For example, Tommy Bahama's Hibiscus Grove Collection uses natural, undulating frame

forms and cast bamboo knots. Lane Venture's Summer Porch and Transitions Collection each incorporate lashings.

Lloyd Flanders's “cane” and “penshell” finishes are brown and mahogany respectively.
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If Plaintiff were granted the sweeping trade dress protection it seeks, all other manufacturers would be foreclosed

from utilizing curving, naturalistic frame forms, natural color fabrics, cast ornamental applications that simulate

natural features in bamboo, simulated lashings, or finishes evocative of tropical materials. Granting Plaintiff a

monopoly on these features would put competitors in the tropical patio furniture industry at a significant nonreputation-related disadvantage. Therefore, applying the comparative necessity test, these elements are functional.

Consequently, summary judgment must be granted for Defendants.

b. There is No Record Evidence of Secondary Meaning

Assuming that Plaintiff could have shown its claimed trade dress was non-functional, it would also have to show

its trade dress has achieved secondary meaning. 11 Secondary meaning is acquired when “in the minds of the

public, the primary significance of a product feature ... is to identify the source of the product rather than the

product itself.” See Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 851, n. 11, 102 S.Ct. 2182, 72 L.Ed.2d

606 (1982). Whether a product has established secondary meaning is a question of fact. Here, the record does not

contain direct evidence that the claimed design elements of Coco Isles or Cabana Bay had achieved secondary

meaning, nor can such a finding be made by simple inference.

11 A producer seeking trade dress protection must prove its product is distinctive. Miller's Ale House, Inc. v. Boynton

Carolina Ale House, LLC, 702 F.3d 1312, 1322 (11th Cir.2012). Previously, a producer could prove distinctiveness

either by showing its product to be inherently distinctive or upon showing it had achieved secondary meaning.

However, in Wal–Mart Stores, Inc. v. Samara Bros., 529 U.S. 205, 120 S.Ct. 1339, 146 L.Ed.2d 182 (2000), the

Supreme Court held a product's design could never be inherently distinctive and therefore, a producer seeking trade

dress protection needed to show secondary meaning. Id. at 216. Plaintiff's opposition overlooks the Wal–Mart rule and

argues, erroneously, that Plaintiff's designs are entitled to trade dress protection by virtue of inherent distinctiveness.

[DE 121, pp. 5–6].

The burden to establish that a product achieved secondary meaning lies with the Plaintiff. Gift of Learning

Foundation Inc. v. TGC, Inc., 329 F.3d 792 (11th Cir.2003). The Eleventh Circuit's predecessor court indicated

that the best way for a plaintiff to prove its product has achieved secondary meaning is survey evidence. Aloe

Creme Labs., Inc. v. Milsan, Inc., 423 F.2d 845, 849 (5th Cir.1970) 12 (“The chief inquiry is the attitude of the

consumer toward the mark; does it denote to him a, ‘single thing coming from a single source?’ Short of a survey,

this is difficult of direct proof”) (internal citation omitted). The record contains neither consumer survey evidence

nor other direct evidence probative of secondary meaning such as testimony from consumers attesting to their

recognition that the collections' designs are associated with Pride Family Brands. 13

12 In Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th Cir.1981) (en banc), the Eleventh Circuit adopted as binding

precedent all decisions of the former Fifth Circuit handed down prior to October 1, 1981.

13 To the extent that the record evidence contains statements by Plaintiff's principals testifying to Pride's products'

superior quality or innovation, those statements are insufficient to raise a genuine disputed issue for trial. Plaintiff's

obligation is to show proof that “establishes the public mind” as to whether its products are associated with their

producer. Aloe Creme Labs., Inc. 423 F.2d at 849. As such, Plaintiff cannot rely on self-serving statements made by

a principal regarding his own impressions of Pride's products, their renown, or reputation as these assertions are nonprobative of the public mind.

*5 Where a Plaintiff cannot marshal direct evidence of secondary meaning, secondary meaning can still be

proven by inference, but the burden is high. For evidence that a product has attained secondary meaning the

Eleventh Circuit looks to: 1) the length and manner of the product's use; 2) the nature and extent of advertising and

promotion; 3) the efforts made by plaintiff to promote a conscious connection in the public's mind between the

trade dress and plaintiff's business; and 4) the extent to which the public actually identifies the name with plaintiffs
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goods and services. Gift of Learning Foundation, Inc., 329 F.3d at 800. An inference of secondary meaning cannot

be drawn from this record evidence.

First, the length and manner of use factors strongly cut against a finding of secondary meaning. The Coco Isles

collection had been on the market for ten years, Cabana Bay for nine. In that time Carl's Patio sold both, but

when Carl's displayed the furniture, it affixed its own hangtags. Despite the overall design, a Carl's customer

would likely, and reasonably, believe, that Carl's made the furniture; very little, if anything, indicates Pride Family

Brands actually manufactured it. Because Pride enabled its retailer customers to customize frame finishes and

fabrics to their liking, offering as many as seventeen different finishes and nineteen different fabrics depending on

collection and piece, it is even less likely that customers could identify a particular piece as being a Pride product

based on its design elements alone.

Skipping for the moment the second factor and turning to the third, Pride's efforts to draw a connection between its

trade dress and its business, by offering its collections under three separate brands, Plaintiff has made it less likely

that a given customer would link Pride furniture's trade dress with its Pride Family Brands origin. For example, a

customer who bought a Coco Isles chair under Castille brand and knew Castille to be associated with Pride Family

Brands, might see the same chair at different retailer but sold under the Prestige brand. This customer would be

less likely to associate the Prestige brand chair with Pride, than if Pride had uniform branding.

The second factor, advertising and promotion, and the fourth factor, extent of actual identification, are not useful

to the analysis because the record evidence is insufficient to draw any meaningful conclusions about secondary

meaning. 14 Given that Plaintiff cannot show its claimed trade dress achieved secondary meaning summary

judgment must be granted for Defendants.

14 Pride's collections were pictured in sales catalogs the company produced at an annual cost of $75,000 and also in the

magazines Hearth & Home, Casual Living, Luxe, and Florida Design. With respect to the catalog expenditures, the

relevant inquiry is not how much Plaintiff spent on advertising, but how effective it was in fostering a consciousness

of origin. Aloe Creme Labs., Inc. 423 F.2d at 850 (5th Cir.1970). There is no record evidence to suggest what, if any,

affect the catalogs had on the public, nor is there any objective evidence from which to infer what that impact might

have been. The record is silent as to how many catalogs were produced, where they were distributed apart from the

trade shows, to whom they were distributed, and how they were distributed. Similarly, there is insufficient evidence

as to the distribution of Hearth & Home, Casual Living, Luxe, and Florida Design magazines to make any reliable

conclusions. There is no record evidence concerning how frequently the collections were advertised or the extent to

which the advertisements linked either the Coco Isles or Cabana Bay collections to Pride Family Brands. With respect

to the fourth factor, evidence of actual identification of the manufacturer by the public based on the mark, there is no

evidence in the record that would support such a conclusion.

c. There is No Record Evidence of Product Confusion

Assuming further still that non-functionality and secondary meaning had been established, the entry of summary

judgment for Defendants would nonetheless be required for a third reason—the record evidence does not support

a finding of customer confusion based on Woodard's using similar trade dress. In the Eleventh Circuit, courts must

weigh each of the following seven factors to determine if a consumer is likely to be confused by similarity in the

parties' trade dress: (1) the strength of the trade dress, (2) the similarity of design, (3) the similarity of the product,

(4) the similarity of retail outlets and purchasers, (5) the similarity of advertising media used, (6) the defendant's

intent, and (7) actual confusion. AmBrit, Inc. v. Kraft Inc., 812 F.2d 1531 (11th Cir.1986). Of these seven factors,

the first, strength of trade dress, and last, actual confusion, are the most important. Star Steakhouse and Saloon,

Inc. v. Lone Star Steakhouse & Saloon of Georgia, Inc., 122 F.3d 1379, 1382 (11th Cir.1997). The burden of

showing confusion is on the Plaintiff. Leigh v. Warner Bros., Inc. ., 212 F.3d 1210, 1216 (11th Cir.2000).

15 The
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seven factors are discussed out of order. Factors one and seven are discussed first, factors three, four, five, and

two are discussed next, and factor six is discussed last.

15 Plaintiff claims Defendant carries the burden on likelihood of confusion. [DE 121, p. 6]. Plaintiff seems to have

overlooked that when the Federal Circuit reviews Lanham Act claims it applies the law of the regional circuit in which

the claim originated. CPG Prods. Corps. v. Pegasus Luggage, Inc., 776 F.2d 1007, 1011 (Fed.Cir.1985). As such,

Eleventh Circuit law, not the Second Circuit case law on which Plaintiff has relied, controls.

i. Factors One and Seven

*6 Strong trade dress indicates the product's source. For example, by observation of just the Coca Cola contoured

bottle, a consumer knows the origin of that soda. See Rock and Roll Hall of Fame and Museum, Inc. v. Gentile

Prods., 134 F.3d 749 (6th Cir.1998). It follows that where a product has a strong trade dress and a rival appropriates

it, the consumer is more likely to be confused as to the rival product's origin. Turning to Pride's claimed trade

dress, it is apparent that is not the case here. As discussed above in relation to secondary meaning, the features

Pride claims as trade dress are generic aesthetic elements of the tropical motif. There is no evidence from which

to conclude that if a hypothetical consumer saw an unlabelled Coco Isles or Cabana Bay furniture piece he would

recognize, based on its design alone, that it was made by Pride.

Nor is there any evidence that any actual consumer has mistaken a Jumby Bay piece for one made by Pride.

Plaintiff claims that “there was definitely confusion on the part of the consumer” and cites to the deposition of CEO

Steve Lowsky for factual support. [DE 121–1, ¶ 2]. Lowsky discusses two instances from Pride's investigation,

but neither amounts to actual consumer confusion. [DE 111–4 199:5–10; pp. 197–198]. In the first instance, a

Pride investigator posed as a consumer and was told by different retailers that Jumby Bay furniture was better and

cheaper than Coco Isles or was told that Pride could no longer supply the store. In the second instance, a retailer in

New York called Lowsky to report that a Woodard salesman offered to sell him a “Coco Isle look-alike.” Neither

of these is evidence of actual confusion by a consumer based on Woodard's use of similar trade dress. As such,

the seventh prong counsels against a finding of consumer confusion.

ii. Factors Two, Three, Four, and Five

Trade dress cannot be viewed in a vacuum. How the trade dress functions in the market place is an important

consideration in determining market confusion. See e.g., Dippin' Dots, Inc., 369 F.3d at 1028 (11th Cir.2004)

(Noting that design similarity increased likelihood of confusion because ice cream novelties are impulse items,

sold to hurried shoppers.); Gray v. Meijer, Inc., 295 F.3d 641 (6th Cir.2001) (Finding a low likelihood of confusion

between store brand popcorn and national brand popcorn with similar labels because store brand popcorn was on

a shelf with other store brand snack food.) Thus, when evaluating factors two, three, four, and five-similarity of

design, similarity of the product, similarity of retail outlets and purchasers, and similarity of advertising media

used-the way the trade dress actually works in the market influences each facet of the analysis.

Factors three, four, and five, do not strongly favor a likelihood of confusion. Factor three considers the similarity

of the product. Here, the products are both outdoor furniture collections in the tropical motif. Similarly, the record

evidence as to the fourth factor, similarity of retail outlets and purchasers, shows both Pride and Woodard sold

their collections to the same customers, outdoor furniture retailers including Carl's Patio. The record evidence is

insufficient to draw any conclusions as to factor five, the similarity of Pride's and Woodard's advertising.

*7 The second factor, similarity of design, strongly disfavors that there was confusion between Plaintiff's and

Woodard's collections. Plaintiff alleges that Woodard's Jumby collection is identical in every way to Plaintiff's

Coco Isle and Cabana Bay collections. 16 Even if it were assumed that Woodard's and Plaintiff's collections were

identical, the Eleventh Circuit requires that similarity of design is evaluated in the “context of the trade dress as
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whole.” AmBrit, Inc., 812 F.2d at 1540. Here, the way the collections are marketed makes confusion between

the two highly unlikely. Pride sells its furniture exclusively to retailers. 17 As industry participants, retailers are

a sophisticated customer base who, it can be assumed, know the different market players and are familiar with

developments in designs and changes in pricing. The marketing channels in the patio furniture industry are wellestablished. Manufacturers, including Pride, show their collections at twice-yearly trade shows, a pre-show in

July and a main show in September. Pride leased large display showrooms at these trade events where only its

collections were displayed. Additionally, a manufacturer might send a sales representative to call on a retailer

customer. Sales representatives only sold one manufacturer's line of furniture. As Steven Lowsky testified, “you

know when a sales rep walks in from Woodard, he's selling Woodard product.” [DE 111–4, 218:4–9].

16 Plaintiff does not address the apparent logical inconsistency of its position given that Plaintiff's CEO explained that

Cabana Bay is different from Coco Isles in that it is made from larger tubing, has a more “nautical feel,” and was

designed to appeal to a different customer.

17 Even if the relevant customer demographic for the confusion analysis were end-use consumers, the likelihood of

confusion is low. First, as is noted elsewhere, brand recognition in the patio furniture industry is low. Steven Lowsky

stated in his deposition that the most important factors in a customer's buying decision were price, comfort, and

appearance. This suggests that a consumer does not make purchasing decisions based on brand. Second, outdoor patio

furniture is not an impulse item. The record evidence shows that outdoor furniture pieces can retail for more than

$1,000 dollars. So while Pride and Woodard might be considered by the same end-user, a consumer looking for Pridemade furniture would likely undertake some investigation given what the product costs.

iii. Factor Six

Finally, the sixth factor considers a defendant's intent in co-opting Plaintiff's trade dress. Plaintiff has vigorously

argued that Defendants Coogan and Woodard copied Pride's designs, not just to capitalize on Pride's goodwill in

the industry, but out of bad faith. Jamie Lowsky, Pride's President, goes so far as to state in his deposition that

Coogan was “so hateful of Pride that no matter where he went he was vengeful to come after us ...” (Deposition

of Jamie Lowsky, DE 61, 94:1–10). Lowsky's speculations as to Coogan's motives are unsupported by the record

evidence. Moreover, though Pride reads Woodard's successful effort to displace Pride's collections in the market

as evidence of bad faith, the record evidence supports a finding that Woodard engaged in fair competition.

The Supreme Court recognized in TrafFix Devices, Inc. v. Mkt'g Displays, Inc., 532 U.S. 23, 29, 121 S.Ct. 1255,

149 L.Ed.2d 164 (2001), that in the trade dress realm “in many instances there is no prohibition against copying

goods and products.” This is especially true where the claimed trade dress is the product's design. As the Court

explained: “Allowing competitors to copy will have salutary effects in many instances. Reverse engineering of

chemical and mechanical articles in the public domain often leads to significant advances in technology.” Id.

(internal quotation marks and citation omitted).

Woodard developed the Jumby Bay line in consultation with Carl's, who previously bought Pride's collections.

Woodard changed its prototype designs based on Carl's recommendation to add lashings and to flare the chair

arms. As is discussed above, Pride does not have a monopoly on the application of lashing or any other generic

element of the tropical motif. Without more, Woodard's efforts to reengineer products to conform to a customer

demands cannot be found to be a bad faith attempt to engage in deliberate confusion.

*8 To the extent Plaintiff attempts to claim that Coogan's reservations about adding lashings are indicative of his

knowledge that Woodard deliberately copied Pride's products for the purpose of confusing customers, Plaintiff

overextends the record evidence. Coogan stated that he did not want to add lashings simply because he had done

that before while designing for Pride. [DE 83–2, pp. 52–53.]. While Plaintiff seems to impute consciousness of

guilt to that sentiment, Coogan's hesitance might equally be ascribed to a designer's desire not to tread ground

he has already covered. Plaintiff also cites Woodard's use of a Coco Isles chair in the development of the Jumby
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Bay collection. As noted above, reverse engineering is not uncommon is a valuable tool which often furthers

competition in the marketplace. Here, Defendant's chief engineer Reed Stauffer testified Woodard's design team

studied the Coco Isles chair in order to surpass its level of comfort. On balance, it is evident that the record evidence

does not support Plaintiff's contention that defendants engaged in bad faith to the extent they incorporate elements

of Plaintiff's trade dress. Overall, based on the record evidence, Plaintiff cannot show a likelihood of confusion in

the minds of consumers between Jumby Bay and Coco Isles or Cabana Bay furniture. For this additional reason,

summary judgment on Plaintiff's trade dress infringement claim must be entered for Defendants.

IV. THE REMAINING CLAIMS

None of Plaintiff's remaining claims, Common Law Unfair Competition (Claim III), Unjust Enrichment (Claim

IV), and Unfair or Deceptive Acts and Practices (Claim V), allege any facts or injury independent of those related

to Plaintiff's Patent Infringement (Claim I) and False Designation of Origin claims (Claim II). Because Defendant's

did not infringe Plaintiff's design patents or trade dress, these claims necessarily fail and summary judgment must

be entered for Defendants on each claim.

V. CONCLUSION

Given that the record evidence fails to establish (i) that Plaintiff's trade dress is nonfunctional; (ii) that Plaintiff's

products had achieved secondary meaning; (iii) and that Defendant's Jumby Bay collection would cause consumers

to be confused about its designation of origin, based on the foregoing, summary judgment must be entered for

defendant as to Claim I. In light of this and the earlier finding that two of Plaintiff's design patents were invalid and

Defendants did not infringe Plaintiff's valid design patents, summary judgment must be granted as to all remaining

claims. Therefore, it is

ORDERED THAT

(1) Defendant's Second and Final Motion for Summary Judgment [DE 111] is GRANTED.

(2) Except for Docket Entry 22, Agreed Plaintiff's Motion to Seal DE 121 and Exhibits, which is resolved by

separate Order, all pending motions are DENIED AS MOOT.

(3) The Court shall separately enter judgment following the resolution of the forthcoming Order to Show Cause.

[See DE 132, p. 1., n.l].

*9 DONE AND ORDERED in Miami, Florida, this 29th day of January 2014.

End of Document © 2014 Thomson Reuters. No claim to original U.S. Government Works.