IN RE: BAYER PHILLIPS COLON HEALTHPROBIOTICS SALES PRACTICES Civil Action No. 11-03017LITIGATION OPINION

John Michael Vazguez, U.S.D.J.

I. INTRODUCTION

This matter comes before the Court on Defendant Bayer Healthcare LLC’s (“Bayer” or

“Defendant”) motion for summary judgment. D.E. 157. Also pending before the Court isPlaintiffs Troy Yuncker and Dino Rikos’ (collectively “Plaintiffs”) motions for class certification(D.E. 143) and motion to strike portions of Defendant’s expert’s opinion (D.E. 165). Plaintiffsallege that Bayer made false and misleading claims regarding one ofits dietary supplements. TheCourt considered the written submissions of the parties’ and considered the motion without oralargument pursuant to Federal Rule of Civil Procedure 78(b) and Local Civil Rule 78.1(b). For the

reasons that follow, Bayer’s motion for summary judgment is granted. Because the Court grants

Bayer’s motion, Plaintiffs’ pending motions (D.E. 143, 165) are denied as moot.

II. BACKGROUND

Bayer’s brief in support of its motion for summary judgment will be referred to as “Def. Br.”

Plaintiffs opposition brief will be known as “P1. Opp.” Bayer’s reply brief will be referred to as

“Def. Rep.”
A. The Dietary Supplement

Plaintiffs filed this action on their own behalf and on behalf of all others similarly situated

who purchased Phillips’ Colon Health (“PCH”), a probiotic dietary supplement sold by Bayer.

Defendants Statement ofMaterial Facts not in Dispute (“DSOF”) ¶ 1 •2 The supplement is provided

to Bayer from another company, Wakunaga ofAmerica Co., Ltd.3 (“Wakunaga”). Plaintiffs allege

that Bayer made “false and misleading” representations in the marketing of PCH. Id. PCH’sproduct label stated as follows:

3 strains of good bacteria to promote

OVERALL DIGESTIVE HEALTH

Helps Defend Against Occasional:

CONSTIPATION

DIARRHEA

GAS AND BLOATING

Id. ¶ 2. Plaintiffs allege that these “statements are false and misleading and reasonably likely to

deceive the average consumer.” Id. At all relevant times, the PCH label contained the statement

2 The Court cites to Bayer’s Statement of Material Facts not in Dispute only when Plaintiffs have

admitted that such facts are undisputed.

The parties do not make clear the actual corporate name of Wakunaga in their moving papers or

the Complaint. The Court derives the name Wakunaga of America Co., Ltd. from the exhibitsthat the parties submitted.

2
when administered in adequate amounts, confer a health benefit on the host.” D.E. 145-7 at 8.

Probiotics are commonly used to “prevent overgrowth of potential pathogens in the gastrointestinal

tract.” Id. Probiotics can lead to better “host defense and nutritional benefits by increasing

indigenous beneficial bacteria and decreasing harmful bacteria.” Id. There are many other

benefits of probiotics and scientists are just beginning to understand all of the functions they

perform in the overall health of human beings. Declaration of Dr. Stefano Guandalini, M.D.

(“Guandalini Dec.”) ¶ 14 (D.E. 160-3). Bacteria are categorized by their genus, species, and strain.

P1. Opp. at 5. The genus, species, and strain for the three PCH bacteria are (1) Lactobacilttts

(genus) gasseri (species) KS-13 (strain); (2) Bzfidobacteriitm bUidum G9-1; and (3)

BJIdodbacterittm iongum MM-2. Id. The parties do not dispute that PCH is regulated as a dietary

supplement, as opposed to a drug.

Pursuant to the Dietary Supplement Health & Education Act of 1994 (“DSHEA”), the

approval process for dietary supplements is less onerous than that required for drugs. The DSHEA

permits the label on dietary supplements “to bear, among other types of statements, a statement

that describes the role of a nutrient or dietary ingredient intended to affect the structure or function

in humans or that characterizes the documented mechanism by which a nutrient or dietary

ingredient acts to maintain such structure or function.” Stanley v. Bayer Healthcare LLC, No. 11-

862, 2012 WL 1132920, at *7 (S.D. Cal. Apr. 3, 2012) (internal quotation marks omitted). These

statements, known as “structure/function claims, are not required to be pre-approved by the FDA.”

3
Dietary supplements need not meet these requirements. Id. Instead, “the only substantiation

requirement is that claims must be ‘truthful and not misleading,” id. (quoting 21 U.S.C. §

343(r)(6)(B)), and a statement “prominently displayed and in boldface type” which says, “This

statement has not been evaluated by the Food and Drug Administration. This product is not

intended to diagnose, treat, cure, or prevent any disease,” 21 U.S.C. § 343(r)(6)(C). “As long as

the supplement is not marketed as a drug -- i.e., it is not claimed to diagnose, mitigate, treat, cure,

or prevent a specific disease or class of diseases, -- it is not regulated like a drug.” FTC Opinion,at *3 (internal quotation marks and citations omitted).

C. Plaintiffs Troy Yuncker and Dino Rikos

Plaintiff Troy Yuncker alleges that he purchased one package of 30-count PCH in May

2011 at a Waigreens store in Chicago, Illinois based on “the digestive health representations” on

the package. Id. ¶ 7. Yuncker was shopping for a probiotic because he “was having bad gas and

digestive problems” due to consuming fast food. Id. ¶ 11. In particular, Yuncker testified that he

had been suffering from “gastrointestinal problems,” which he later identified as acid reflux, for

at least ten years prior to using PCH. Id. ¶ 12. Yuncker consumed one pill of PCH per day for a

period of nine days and then stopped taking the supplement. Id. ¶ 13-14. Yuncker believed that

PCH was ineffective because his “gas and constipation [had not] changed.” Deposition of Troy

Yuncker (“Yuncker Dep.”) at 85:3-7.

4
a diagnosis of colon and rectal cancer, chemotherapy, radiation, and colon resection surgery. Id.

¶ 20. Rikos believed that PCH “wasn’t doing anything” to cure his symptoms, and as a result,

decide to file suit against Bayer for false advertising. Deposition of Dino Rikos (“Rikos Dep.”)

48:18 to 49:6.

D. The Scientific Studies

There are three scientific studies that both Plaintiffs and Defendant claim play a significant

role in the outcome ofthis motion. Each study was a double-blind, placebo randomized controlled

trial (“RCT”).4 RCTs are known in the scientific community as the “gold standard” for scientificstudies. Mttltins v. Premier Nutrition Corp., 178 F. Supp. 3d 867, $82 (N.D. Cal. 2016)

(“Randomized clinical trials are ‘the gold standard for determining the relationship of an agent to

a health outcome.” (quoting Federal Judicial Center, Reference Manual on ScientUic Evidence

555 (3d ed. 2011))).

‘ An RCT is defined as

[am experimental study to assess the effects of a particular variable

(e.g., a drug or treatment) in which subjects are assigned randomly

to an experimental, placebo, or control group. The experimental

group receives the drug or procedure; the placebo group’s

medication is disguised to resemble the drug being investigated.

The control group receives nothing. Laboratory tests or clinical

evaluations are performed on the groups (usually using the double

blind technique) to determine the effects ofthe drug procedure.

Taber ‘s Cyclopedic Medical Dictionaiy 1847-48 (20th ed. 2006).

5
of an investigational Probiotic on Irritable Bowel Syndrome.” Id. The study used the same threestrain bacteria that make up Bayer’s PCH. Id. at Ex. 54. The results of the Canada I Study

indicated that the active group5 and placebo group both experienced “significant improvements”in Irritable Bowel Syndrome (“lBS”).6 Id. at Ex. 54. The study found that “the greatest difference

in effect between active and placebo groups [was] seen in the [d]iarrhea subtype.” Id. The greatesteffect regardless of whether the participant was in the active or placebo group was seen in theconstipation subtype. Id. However, despite these positive trends, the Canada I Study concluded

that the “difference between the groups is not statistically significant” and the “sample size

amongst the subtypes is not large enough to draw a definite conclusion.” Id.

The second RCT took place in 2013 and “was performed to test the effect of [PCH] on the

severe sufferers of [IBS].” Id., Ex. 58 (the “Canada II Study”). The analysis of the Canada II

Study was conducted by the Centre for Quantitative Analysis and Decision Support at Carleton

University. Id. The study concluded that the use ofPCH on severe lBS participants did not “reveal

a statistically significant treatment effect.” Id. at 2. The Canada II Study acknowledged that the

differences in improvement between the active and placebo groups “were nearly significant,” but

ultimately found that “the large placebo effect and high fluctuating nature of lBS on a day-to-day

The “active group” designates the participants that took the three bacteria strains.

6 is a “chronic, reoccurring gastrointestinal disorder. . . characterized by abdominal pain,

bowel dysfunction and bloating in the absence of any structure abnormalities.” Cecchi Dec., Ex.

54.

6
The third RCT, known as the “Florida Study,” was conducted by researchers at the

University of Florida and published in 2015. Id., Ex. 59. The Florida Study used the same threestrain bacteria contained in PCH. Id. at 1. The objective of the study was to determine “whether

older adults who consumed a probiotic mixture would have a greater proportion of circulatingCD4+ lymphocytes, altered cytokine production, and a shifi in intestinal microbiota toward a

healthier microbial community.” Id. The study consisted of 32 healthy adults between the ages

of 65 and 80. Id. at 5. It was designed not to detect changes in clinical symptoms, but in“biomarkers.” Id. at 1. Biomarkers are defined as a “detectable cellular or molecular indicator ofexposure, health effects, or susceptibility, which can be used to measure the absorbed,

metabolized, or biologically effective dose of a substance, the response to the substance including

susceptibility and resistance, idiosyncratic reactions, and other factors or conditions.” Stedman ‘s

Medical Dictionary 221 (28th ed. 2006).

The Florida Study concluded that the probiotic mixture “maintained CD4+ lymphocytes

and produced a less inflammatory cytokine profile in healthy older adults.” D.E. 145, Ex. 59 at9. The study found that the “changes may have been due to changes in the microbial communities,

which more closely resemble those observed in healthy younger populations.” Id. While theFlorida Study concluded that “healthy older adults may benefit from ingesting this probiotic mix,”it suggested that “future studies should explore inflammatory changes and health-related outcomesin an at-risk population.” Id.

7
research testing probiotics, authored more than 200 peer-reviewed publications, and presented

more than 300 invited lectures. Id. ¶ 3-5.

In his deposition, Dr. Guandalini opined that PCH “has been clinically proven to be

ineffective” for people with 13$. Deposition of Dr. Stefano Guandalini, M.D. (“Guandalini Dep.”)

at 69:14-16; 176:13-18. Dr. Guandalini explained that for a claim about a dietary supplement,such as PCH, to be true it must be supported by “competent and reliable scientific evidence,” which

requires “well conducted clinical trials.” Id. at 68:17-21; 150:2-12. Dr. Guandalini defined “wellconducted clinical trial” to mean, among other things, that the study should not be initiated by the

industry, possibly be conducted “in a multi-center fashion, be double blind and placebo controlled,

consist of a sufficient number of sufficient participants to reach statistically significant results, becarefully analyzed, and be subject to.peer review. Id. at 137:6 to 138:1; see also id. at 161:4-8

(stating that an RCT would be required to state that a product “helps promote digestion”). Dr.Guandalini stated that the reason he believes “well-conducted clinical trials” are necessary is

because doing so is “good clinical practice.” Id. at 140:9-19. According to Dr. Guandalini, the

testing required to determine the efficacy of a product is the same whether the product is classified

as a drug or a dietary supplement. Id. at 6 1:6-10. Dr. Guandalini also testified that he did not“have enough authority to express a judgment on” the difference between the Food and Drug

Administration’s regulations on drugs compared to dietary supplements. Id. at 62:24 to 63:5.

$
7. However, Dr. Guandalini recognized some limitations in the results ofthe Canada I and Florida

Studies. In regard to the Canada I Study, Dr. Guandalini noted that the study’s results were limited

to showing that PCH did not cause a statistically significant improvement in adults with symptoms

of IBS, as opposed to less severe gastrointestinal issues or general health maintenance. Id. at

163:22 to 164:9. Dr. Guandalini agreed that PCH’s effect on lBS symptoms and its effect on

overall digestive health are distinct inquiries:

Q. Okay. Now, whether a therapy shows significant changes in lBSsymptom severity does not necessarily tell us whether or not a

therapy supports overall digestive health in a healthy population,right?

A. Yeah, right.

Id. at 165:10-14. Additionally, as to the Florida Study, Dr. Guandalini explained that its results of

PCH’s ineffectiveness were limited to the particular patient population of “70 years and older.”

Id. at 158:9-14.

Dr. Guandalini was asked whether he believed that PCH effectively promoted overall

digestive health in adults who do not have IBS, to which he provided inconsistent responses. first,

he opined that there was sound scientific evidence that PCH is ineffective for adults with lBS.

while leaving open the possibility that PCH could be effective for someone without IBS:

In his deposition, Dr. Guandalini said he relied only on these two studies. Guandalini Dep. at

69:10-11; 164:3-7. It appears, however, that Dr. Guandalini subsequently considered the CanadaII study as it was discussed in his declaration submitted in connection with this motion. See D.E.

160-3 ¶35.

9
Q. You are not opining that PCH is incapable o

e

p

g to p

overall digestive health, you just don’t how one way or the other?

A. I don’t know.

Id. at 175:18-21; 177:2-5. Then Dr. Guandalini clarified that he would “be surprised if [PCH

promoted overall digestive health] considering the small amount of bacteria contained in the

preparation.” Id. at 177:2-9. Next, Dr. Guandalini stated that he believed that PCH was

“incapable ofprotecting against” symptoms ofoccasional constipation, diarrhea, gas, and bloating.

Id. at 178:7-23. The colloquy took place as follows:

Q. Okay. Let’s go back. My original question was, you are not

opining that PCH is incapable of helping to defend againstoccasional constipation, diarrhea, gas, and bloating?

A. In my opinion, it is incapable of protecting against those

symptoms as well, based on the fact that is was so clearly negativein the population of lBS sufferers, which, once again, are a

population closely resembling, overlapping those that the claims aremade for. I hope I made myself clear. So the strong evidence of

lack of efficacy, clinical proven ineffective to treat patients with

irritable bowel syndrome, on that I stand firm. I want to add, in

addition, my opinion is that given this proof of inefficiency, it’s

extremely likely that we’ll also not be able to protect from the

occasional onset of symptoms. I really see no evidence to support

that.

Id. Finally, Dr. Guandalini was asked:

Q. Can you completely rule out that PCH provides health benefits

to some people?

A. No, I cannot.

10
F. Defendant’s Expert

Defendant’s Expert, Dr. Daniel I. Merenstein, M.D. is a tenured associate professor at

Georgetown University where he focuses his research on probiotics and sinusitis and also teaches

in both the undergraduate and medical schools. Declaration of Daniel J. Merenstein, M.D.

(“Merenstein Dec.”) ¶J 1, 3, 5. (D.E. 157-9). In the past six years, Dr. Merenstein was the principal

investigator on seven probiotic clinical trials. Id. ¶ 6. Dr. Merenstein also works as a family

physician with specialties in pediatrics and infectious and gastrointestinal diseases. Id. ¶ 4.

Dr. Merenstein opined that PCH helps alleviate diarrhea, constipation, gas, and bloating.

Deposition of Daniel J. Merenstein, M.D (“Merenstein Dep.”) 180:13 to 182:19. (D.E. 160-1). In

particular, Dr. Merenstein “believe[s] that PCH can effectively help individuals who are generallyhealthy but suffer from occasional constipation, diarrhea, gas, and bloating.” Merenstein Dec. ¶

50. However, Dr. Merenstein acknowledged that although PCH promotes overall digestive health

for some users, it may not do so for all people. Dr. Merenstein explained his position as follows:

Q. Does Phillips Colon Health promote overall digestive health foreveryone?

A. No. We talked about that I think in the last hour, that there isnothing out there that does it for everyone. People can exercise

and have a heart attack. People can get a flu vaccine and get

the flu. And people can take Phillips Colon Health and havediarrhea.

Q. Okay. Does PCH promote overall digestive health at least forsome users?

11
Q. But it does for some users, correct?

A. It does for some users.

Id. at 337:7 to 338:2.

Dr. Merenstein was asked for his opinion regarding the results of the Canada I, Canada II,

and Florida Studies. Dr. Merenstein described the two Canada Studies as “null studies.” Id. at

237:5-11. Dr. Merenstein found them to be “null studies” because they did not support the theory

that PCH had a different effect on the active participants when compared to those who took the

placebo. Id. at 237:18-21. Dr. Merenstein opined that although the two Canada Studies did not

demonstrate that PCH “helps defend against occasional diarrhea, constipation, gas, or bloating,”

Id. at 237:5-11; 239:19 to 240:4, the testing in these studies was targeting PCH’s effect on

participants with lBS as opposed to its effect on digestive health outcomes, Id. at 23 7:22 to 23 8:4.

In other words, Dr. Merenstein believed that each of the Canada Studies “tell us nothing about the

cause and effect between probiotic use and helping to promote overall digestive health (as opposed

to IBS), which is what the PCH label claims.” Merenstein Dec. ¶ 55. As to the Florida Study, Dr.

Merenstein stated that it “support[ed] Bayer’s claims as part ofthe totality ofscientific evidence.

and proved PCH to be beneficial for the maintenance of gut homeostasis.” Merenstein Dec. ¶

56.

G. Procedural History

12
unlawful business acts and practices in violation of California Business & Professions Code

Section 17200, et seq. (on behalf of Plaintiff Rikos and the California subclass), (4) violation of

Illinois’ Consumer Fraud Act, 815 ILCS 505/1, et seq. (on behalf of Plaintiffs Rikos, Yuncker,

and the Illinois subclass), (5) breach ofimplied warranty ofmerchantability,8 (6) unjust enrichment

(on behalf of Plaintiffs Rikos, Yuncker, and all class members). D.E. 94.

Defendant filed a motion to dismiss the complaint, which the Court granted in part and

denied in part. D.E. 114. The Court denied the motion as to Counts Two through Six, but

dismissed Plaintiffs’ claim under the New Jersey Consumer Fraud Act. Id. Then, after discovery,Bayer moved for summary judgment on the remaining counts, which Plaintiffs oppose.

III. LAW AND ANALYSIS

A. Standard of Review

A moving party is entitled to summary judgment where “the movant shows that there is no

genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”

Fed. R. Civ. P. 5 6(a). A fact is “material” when a dispute over that fact “might affect the outcome

of the suit under the governing law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).Importantly, “[f]actual disputes that are irrelevant or unnecessary will not be counted.” Id. A

material fact raises a “genuine” dispute “if the evidence is such that a reasonable jury could return

a verdict for the non-moving party.” Williams i’. Borough of W. Chester, $91 F.2d 458, 459 (3d

8 In Plaintiffs opposition brief, they clarified that they are not seeking certification of this claim.

13
the facts and any reasonable inferences drawn therefrom in the light most favorable to the party

opposing summary judgment.” Inter Vest, Inc. v. Bloomberg, L.P., 340 F.3d 144, 159-60 (3d Cir.

2003) (citing Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 456 (1992)).

Summary judgment is appropriate “against a party who fails to make a showing sufficient

to establish the existence of an element essential to that party’s case, and on which that party will

bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Under those

circumstances, “there can be ‘no genuine issue as to any material fact,’ since a complete failure of

proof concerning an essential element of the nonmoving party’s case necessarily renders all other

facts immaterial.” Id. at 322-23. However, to withstand a motion for summary judgment, the

nonmoving party need only “come forward with evidence which, if believed, would support a

finding in its favor.” In re Bressman, 327 f.3d 229, 237 (3d Cir. 2003).

B. The Federal Trade Commission Opinion

In September 2015, Judge Linares issued an opinion relevant to the issues arising in this

case. See United States v. Bayer Corp., No. 07-01, 2015 WL 5822595 (D.N.J. Sept. 24, 2015) (the“FTC Opinion”). In particular, the FTC Opinion analyzed (1) the different regulatory standardsapplicable to a dietary supplement as opposed to a drug, (2) the type of scientific evidence

necessary to demonstrate that a dietary supplement, such as PCH, is “truthful and not misleading,”

and (3) the significance of the Canada I and Florida Studies.

14
that Bayer was barred “from making any representation, directly or by implication, concerning the

need for or benefits to be derived from consumption of such [dietary supplements], unless, at the

time such representation is made, [Bayer] possesses and relies upon a reasonable basis consisting

of competent and reliable scientific evidence to substantiate the representation.” Id. At issue was

whether Bayer possessed adequate substantiation for its claims that PCH “prornote[s] overall

digestive health” and that it “helps defend against occasional constipation, diarrhea, gas, and

bloating.” Id. at *2, 5.

Judge Linares first recognized the regulatory differences between a dietary supplement and

a drug. He explained that drugs are held to a higher standard requiring pre-approval from the FDA

and usually must be supported randomized, placebo controlled, double-blind clinical trials, while

dietary supplements do not. Id. at *3• Judge Linares determined that Bayer did not market PCH

as a drug because it never made claims that PCH treats, prevents, or cures any diseases. The court

noted that “[e]very package of PCH and every advertisement contains a disclaimer that that PCHis ‘not intended to diagnose, treat, cure or prevent any disease.” Id. at *12. Additionally, there

was no evidence that the language on PCH’s packages and advertisements would expressly orimpliedly make a consumer believe PCH was making a disease claim. Id. at * 13. Therefore, the

court concluded that substantiation of PCH was evaluated by the lower standard used for dietary

supplements. Id.

15
procedures generally accepted in the profession to yield accurate and reliable results.” Id. (quoting

PX—1 Dieta,’y Sttpplements: An Advertising Guide for Indttstry at 3). The FTC makes clear thatRCTs are not required to meet the standard of “competent and reliable scientific evidence.” Id.“Instead, competent and reliable scientific evidence is a flexible standard, and there is no fixed

formula for the number or type ofstudies required.” Id. In short, dietary supplements are evaluated

by looking to the “totality ofthe evidence.” Id. at *4 The court noted that the FTC’s requirement

of “competent and reliable scientific evidence,” was the same level ofproofrequired by the consentdecree for Bayer to substantiate its claims regarding PCH. Id. at *3•

Judge Linares also discussed many of the studies Bayer relied upon to substantiate its

claims about PCH. Two of those studies were the Canada I and Florida Studies. The courtexplained that the Florida Study “showed a positive impact in its primary outcome” and that PCH“was proven to be beneficial for maintenance of gut horneostasis” such as “digestive health and

the absence of symptoms like constipation, diarrhea, gas and bloating.” Id. at *9 (internal

quotation marks omitted). As to the Canada I Study, Judge Linares found that it was a “primarily

neutral study but showed results that trended positive for digestive health benefits.” Id. (internal

quotation marks omitted). The court noted that “the study was underpowered meaning there were

not enough people to show a statistically significant benefit,” but that Bayer’s substantiation of

PCH was not undercut “because many successful products, including FDA-approved drugs have

neutral studies.” Id.

16
standard. Bayer needed to subject PCH to a double-blind, placebo controlled RCT. Id. at *9 The

Government’s expert admitted that “his study design did not distinguish between drugs or

supplements.” Id. Significantly, the Government’s expert was not familiar with the regulations

for dietary supplements nor was he familiar with FTC guidance concerning the “substantiation

necessary for dietary supplement claims.” Id. at *10.

Judge Linares concluded that Bayer did not violate the consent decree by failing to rely

upon RCTs to support its claims about PCH. Id. at *14. Judge Linares explained that, contrary to

the opinion ofthe Government’s expert, proof of “competent and reliable scientific evidence” does

not require RCTs pursuant to the regulations and FTC guidance. Id. Moreover, nothing in the

consent decree required Bayer to conduct RCTs to support its claims concerning PCH. Id. at * 16.

Judge Linares also ruled that the Government’s expert’s opinion failed to satisfy the Government’s

burden. Id. at *1516. The court criticized the Government’s expert for “not paying attention to

the law or regulations about the difference between dietary supplements and drugs’ in formulating

his opinion.” Id. at *16. Judge Linares explained that the Government’s expert opinion that an

RCT was necessary was “directly contrary” to the legal requirement as well as contrary to FTC

guidance. Id. Judge Linares further concluded that Bayer possessed and relied upon competentand reliable scientific evidence in support its claims about PCH. Id. at *1819. Bayer’s medical

lead for PCH “reviewed and relied upon [relevant] scientific studies in the public domain.” Id. at

* 18.

17
material fact to preclude summary judgment. However, the FTC Opinion is instructive. Like the

Government’s expert in the FTC Opinion, Plaintiffs’ expert testified that a double-blind, placebocontrolled RCT was necessary. Not only does this testimony misstate the correct legal

requirements for dietary supplements, it also confuses the burden of proof. Plaintiffs must prove

that Defendant’s claims concerning PCH are false and misleading. Significantly, Plaintiffs did not

conduct their own double-blind, placebo controlled RCT to support their position. In addition,

like the Government’s expert in the FTC Opinion, it does not appear that Plaintiffs’ expert was

aware of the different legal standards that govern dietary supplements as opposed to drugs.

C. California and Illinois Consumer Protection Statutes

Plaintiffs allege causes of action under the Consumers Legal Remedies Act, California

Civil Code § 1750, et seq. (“CLRA”), false or deceptive advertising in violation of CaliforniaBusiness and Professions Code, Cal. Bus. & Prof. Code § 17200 et seq. (“UCL”), and violation of

the Illinois Consumer Fraud Act, 815 ILCS 505/1, et seq. (“ICFA”).

California’s CLRA generally prohibits “unfair methods of competition and unfair or

deceptive acts or practices.” Cal Civ. Code § 1770. California’s UCL prohibits any “unlawful,

unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading

advertising.” Cal. Bus. & Prof. Code § 17200. In evaluating a claim under the CLRA and UCL,

the court must determine whether a reasonable consumer is likely to be deceived by the defendant’s

unlawful conduct. Williams v. Gerber Prod. Co., 552 F.3d 934, 938 (9th Cir. 2008). When

18
caimot prevail by arguing that the defendant’s claims are itnstthstantiated and therefore

misleading.” Mttllins, 178 F. Supp. 3d at 892 (emphasis added); see also Alottdi v. Intramedic

Research Grp., LLC, 2015 WL 4148381, at *4 (N.D. Cal. July 9, 2015) (dismissing UCL and

CLRA claims averring that defendant failed “to provide adequate substantiation” that its

advertising claims were true); Stanley, 2012 WL 1132920, at *3 (“Private individuals may not

bring an action demanding substantiation for advertising claims. . . only prosecuting authorities

may require an advertiser to substantiate its advertising claims.”).

The third consumer protection statute at issue, the ICFA, “protects consumers against

‘unfair or deceptive acts or practices,’ including ‘fraud,’ ‘false promise,’ and the

‘misrepresentation or the concealment, suppression or omission of any material fact.” Wigod v.

Wells Fargo Bank, NA., 673 F.3d 547, 574 (7th Cir. 2012) (quoting 815 ILCS 505/2). The

elements of a claim under the ICFA are “(1) a deceptive or unfair act or practice by the defendant;

(2) the defendant’s intent that the plaintiff rely on the deceptive or unfair practice; and (3) the

unfair or deceptive practice occurred during a course of conduct involving trade or commerce.”

Siegel v. Shell Oil Co.. 612 F.3d 932, 934 (7th Cir. 2010). Similar to the UCL and CLRA, to

demonstrate a deceptive act or practice under the ICFA, the plaintiff has the burden to show that

the defendant’s alleged misrepresentations were actually false. Baldwin v. Star Sd., Inc., 78 F.

Supp. 3d 724, 738 (N.D. Ill. 2015) (concluding that plaintifffailed to state a claim under the ICFA

when he failed to allege “how [dJefendant’s alleged misrepresentations were false”); see also

19
presented proof of falsity regarding Bayer’s claims that PCH “promotes overall digestive health”

and “helps defend against occasional constipation, diarrhea, gas, and bloating.” Merely proving

that the claims are unsubstantiated is insufficient. Two cases from the Southern and Northern

Districts ofCalifornia illustrate the necessary level ofproofto defeat summary judgment in a claim

for false advertising.

In Mttllins, the court addressed claims under the UCL and CLRA alleging that the

defendant made false or misleading representations in selling its product “Joint Juice.” 17$ F.

Supp. 3d at 875. Joint Juice was a liquid dietary supplement that was marketed to remedy pain

and stiffness in arthritic joints, but according to the plaintiff, was actually nothing more than “snakeoil.” Id. The active ingredients in Joint Juice were glucosarnine hydrochloride (“glucosamine”)

and chondroitin sulfate (“chondroitin”).

The court in Mttllins concluded that the plaintiff “advanced evidence which directly

supports the contention that certain of [the defendant’s] representations are false or misleading.”

Id. at 876. The plaintiff presented evidence ofJoint Juice’s inefficacy through numerous RCTs in

the form ofrandomized double-blind, placebo-controlled studies. Id. at 882-84. The plaintiff alsoproduced meta-analyses9 clinical treatment protocols, and bioavailability studies in support of her

theory. Id. at 884-887. Among various types ofmedical evidence, meta-analyses are “considered

‘ “Meta-analyses pool the results of clinical trials to arrive at a single figure to represent the

totality of the studies reviewed.” Mitilins, 17$ F. Supp. 3d at $84 (internal quotation marksomitted).

20
reached the targeted joint cartilage and, even if they did, the amount was too small to have any

meaningful effect on the joints. Id. at 886-87.

The district judge in Mttllins acknowledged that the defendant’s expert advanced some

evidence, such as in vitro and preclinical animal studies, to refute the plaintiffs position, but that

many ofthe sources relied upon by the defendant’s expert could be deemed unreliable. Id. at 895.

For example, the defendant’s expert failed “to take into consideration the hierarchy of scientific

evidence, which places meta-analyses and randomized clinical trials at the top” and also relied on

certain studies “characterized by poor design” or industry bias. Id. The Multins court found thatdue to the competent evidence presented by the plaintiff, and because the plaintiff “offered

principled, supported critiques of the studies [the defendant’s experti used to form his opinions,

and a jury may reasonably adopt those same views, [the plaintiff] may be able to convince a jury

that [the defendant’s] claims are literally false.” Id. at 896. Therefore, the district court denied

the defendant’s motion for summary judgment.

In Stanley, the Southern District of California addressed claims under the CLRJ& and UCL,

which alleged that Bayer made false and misleading statements regarding PCH, the same product

at issue in the instant matter. 2012 WL 1132920, at *1.2. The plaintiff alleged that Bayer violated

the CLRA and UCL by stating, among other things, that PCH “promote[s] overall digestive health”

and “helps defend against occasional constipation, diarrhea, gas, and bloating.” Id. at *5

21
(internal quotation marks omitted). The Stanley court noted, however, that none of the plaintiffsexperts actually opined that the claims about PCH were false or explained how the contestedstatements might mislead a reasonable consumer. Id. Instead, the plaintiffs experts repeatedlyasserted that the statements were false or misleading due to a lack of substantiation. Id. forexample, one expert was asked whether he could “rule out that probiotics do work for some

people,” to which he responded, “it’s inconclusive.” Id. at *6. Additionally, the plaintiffs expertswere not aware of the different regulations for drugs and dietary supplements. Id. at *7• To the

contrary, one expert opined that “he believe[d] [d]efendant should have the same support for itsPCH claims as drug companies must have for their drug claims, i.e. proof of efficacy in placebocontrolled double-blind human studies.” Id.

The district court held that the plaintiff had not met her burden in demonstrating that

Bayer’s statements about PCH were actually false or misleading. Id. In granting Bayer’s motion

for summary judgment, the court in Stanley concluded by noting that the plaintiff “cannot create a

genuine issue ofmaterial fact regarding whether Defendant met the level ofsubstantiation required

under federal law by presenting opinions from experts who are not aware ofthe relevant regulatory

standards.” Id.

D. Analysis

Here, Plaintiffs failed to meet their burden of proof of showing that PCH’s claims of

promoting “overall digestive health” and “defend[ing] against occasional constipation, diarrhea,

22
Opinion, Dr. Guandalini does not recognize the difference in proof required to substantiate a

dietary supplement as compared to a drug. As noted, drugs require pre-approval from the FDA

and generally “must be supported by randomized, placebo controlled, double-blind clinical trials.”

FTC Opinion, at *3 Dietary supplements, in comparison, require only that the statements made

regarding their properties are “truthful and not misleading.” 21 U.S.C. § 343(r)(6)(B). To be

“truthful and not misleading,” the statements must be supported by “competent and reliable

scientific evidence.” FTC Opinion, at *3• Importantly, RCTs may be used to satisfy this standard,

but they are not required. Id.

Dr. Guandalini testified that in order for Bayer’s statements about PCH to be true, they

must be supported by double-blind, placebo controlled “well conducted clinical trials,” which he

equates to RCTs. Guandalini Dep. at 6$: 17-21; 150:2-12; 161:4-8. Dr. Guandalini believes RCTs

are necessary because they are “good clinical practice.” Id. at 140:12-19. However, RCTs are not

required for a dietary supplement. Further to the point, Dr. Guandalini testified that his opinion

about a product’s efficacy would not change regardless of whether it is a drug or a dietary

supplement. Id. at 61:6-10. In his words, “[e]ither a compound works or it doesn’t.” Id. Dr.

Guandalini candidly admitted that he did not have enough knowledge “to express a judgment” on

the different types of regulations and requirements for drugs versus dietary supplements. Id. at

62:24 to 63:2. Dr. Guandalini was asked whether he was aware that in the FTC Opinion, the Court

“already found that dietary supplements do not need to be supported by randomized, placebo

23
undercuts Plaintiffs’ argument that “[t]his is not a lack of substantiation case because Plaintiffs

present evidence that PCH does not work as advertised.” P1. Opp. at 26. Dr. Guandalini’s opinion

is nothing more than a lack-of-substantiation theory. In essence, Plaintiffs’ expert opines that

absent an RCT showing PCH’s efficacy, Bayer’s claims that PCH promotes digestive health are

false. This lack-of-substantiation theory is not the legal standard. Without understanding the

proper legal requirements to demonstrate whether Bayer’s statements about PCH are false and

misleading, Dr. Guandalini cannot offer an informed opinion as to whether that standard has been

met. See Stanley, 2012 WL 1132920 at *7 (“Plaintiff cannot create a genuine issue of material

fact regarding whether Defendant met the level of substantiation required under federal law by

presenting opinions from experts who are not aware of the relevant regulatory standards.”).

Certainly, using RCTs to substantiate PCH may be a reliable scientific method to show its efficacy

(or lack thereof), but such studies are not required as a matter of law. See FTC Opinion, at *3

Second, Dr. Guandalini’s interpretation of the Canada I & II and Florida Studies does not

prove actual falsity. The purpose of the Canada Studies was to determine the effect of PCH on

people who have lBS and severe lBS. The studies were not designed to test whether PCH

“promote[s] overall digestive health” and “helps defend against occasional constipation, diarrhea,

gas, and bloating.” DSOF ¶ 2 (emphasis added). The difference in the symptoms of those withlBS and the syn-iptoms that PCH purports to defend against are materially different in terms of

severity. lBS is a “chronic, reoccurring gastrointestinal disorder... characterized by abdominal

24
symptom severity does not necessarily tell us whether or not a therapy supports overall digestive

health in a healthy population.” Guandalini Dep. 165:10-14. Dr. Guandalini implied multipletimes that PCH could potentially be effective for someone without 13$:

Q. So then your opinion leaves open the possibility that PCH may

work for someone without IBS, correct?

A. Well, yeah.

Id. at 175:18-21.

Q. But for people who do not [have 13$] we do not have proof that

the claims are false, correct?A. Neither that they are correct, yes, that’s correct, but neither do we

have proof that the statement is true.

Id. at 176:8-12.

Q. You are not opining that PCH is incapable of helping to promoteoverall digestive health, you just don’t know one way or the other?

A. I don’t know.

Id. at 177:2-5. In short, Dr. Guandalini did not offer a definitive opinion as to whether PCH’s

claims that it promotes overall digestive health and helps defend against occasional constipation,

diarrhea, gas, and bloating were actually false.

Dr. Guandalini attempted to backtrack from his equivocal answers by claiming PCH is

ineffective in treating occasional digestive problems. Dr. Guandalini stated that he “would be

surprised” if PCH promoted overall digestive health “considering the small amount of bacteria

25
added).

Yet, even Dr. Guandalini’s modified opinion is nothing more than a theory of lack of

substantiation. At worse, it is pure speculation in light of the fact that he never clinically tested

his views, and, at best, it is an educated guess. However, either is insufficient to carry Plaintiffs’

burden of showing that the PCH’s statements are actually false or misleading. Dr. Guandalini

stated that he saw “no evidence to support” the statement that PCH helps promote digestive health.

As discussed above, the question is not whether there is sufficient evidence to support PCH’s

claims, but rather whether Plaintiffs have presented proof that PCH’s claims are in fact false or

misleading. Moreover, Dr. Guandalini’s testimony that “he would be surprised” if PCH was

effective is a far cry from the scientific proof necessary to show actual falsity.

Dr. Guandalini’s attempt to extrapolate the results ofthe lBS Canada Studies to those with

occasional symptoms of constipation. diarrhea, gas, and bloating is unavailing. The Canada I

Study concluded that it was conducted with too small of a sample size to draw a definite

conclusion. Yet, there were indications of affirmative results for general digestive health. Cecchi

Dec., Ex. 55; see also FTC Opinion at *9 (noting that Canada I Study was “primarily a neutral

study but showed results that trended positive for digestive health benefits . . . [except that] the

study was underpowered meaning there were not enough people to show a statistically significant

benefit” (internal quotation marks omitted)). Dr. Guandalini offers no explanation why

extrapolating from an inconclusive study about lBS to draw a conclusion about a different

26
Bayer’s claims about PCH fail to meet the standard of “truthful and not misleading.”

The third and final RCT, the Florida Study, also does not show that the PCH claims are

false or misleading. In the FTC Opinion, Judge Linares found that the Florida Study “showed a

positive impact in its primary outcome” and that PCH “was proven to be beneficial for

maintenance of gut homeostasis” such as “digestive health and the absence of symptoms like

constipation, diarrhea, gas and bloating.” FTC Opinion, at *9• But even assuming that the Florida

Study showed that PCH was ineffective, its results nonetheless do not prove that Bayer’s claims

about PCH are in fact false. The Florida Study was limited to adults between the age of 65 to $0.

Therefore, the study provides no basis to conclude that Bayer’s claims about PCH are untrue for

people who fall outside this age range.’°

Lastly, Plaintiffs’ reliance on In re Neitrontin Marketing & Sates Practices Litigation, 712

F.3d 21(1st Cir. 2013) is misplaced. In that case, the first Circuit held that where “numerous

[double-blind randomized controlled trials] indicate that a drug is ineffective, that provides

powerful scientific evidence of inefficacy.” Id. at 49. Here, the only RCTs are the three studies

discussed above. The Canada Studies tested PCH’s effectiveness on individuals with lBS and

10 Plaintiffs also cite a report from the European Food Safety Authority (“EF$A”) which found

there is no evidence that “PCH ingredients support respiratory tract defenses or resulted in a

decrease in duration or severity of the common cold.” P1. Opp. at 12. Plaintiffs present no legalargument regarding the significance, if any, ofthis report to the claims at issue concerning overall

digestive health. This matter concerns digestive health. The common cold and the respiratory

tract are not the issue.

27
symptoms. Therefore, In re Neurontin Marketing & Sales Practices Litigation is inapposite.

This matter is very similar to Stan1ev, not only because the same product is involved but

also due to the nature of Plaintiffs’ proofs. Moreover, Plaintiffs’ case suffers from many of thesame infirmities found by Judge Linares in the FTC Opinion. Plaintiffs’ expert is incorrect as to

the medical evidence necessary for a dietary supplement. Furthermore, and unlike Mullins,

Plaintiffs have presented no meta-analyses or bioavailability studies.

Plaintiffs also argue that Bayer’s internal documents indicate that Bayer marketed PCH

toward women aged 35 or older who suffer from lBS and that Bayer anticipated that 15% of its

customers would use PCH for lBS. PL. Opp. at 4. In Mullins, the court explained that evidence

of targeting a specific group of consumers maybe considered to show that a dietary supplement’s

implied claims are false or misleading, but it may not be used to substantiate the falsity of general

health claims. 178 F. Supp. 3d at 896. There, the plaintiff hired an expert to analyze the

defendant’s marketing materials, advertisements, marketing research, and customer surveys todetermine why consumers purchased Joint Juice. Id. at 8 80-82. The plaintiff’s expert concluded

that “the primary appeal and driving reason consumers purchase Joint Juice are joint health and

joint pain” and that “consumers understand [the defendant’s] implied claims about the palliative

and structural benefits of drinking the product.” Id. at 880-8 1 (internal quotation marks omitted).

In other words, the plaintiff in Mttllins presented evidence that the “vast majority of consumers

28
digestive health and helping to defend against occasional constipation, diarrhea, gas, and bloating.Instead, Plaintiffs point to Bayer’s internal documents which indicate that Bayer targeted

individuals with lBS and that it believed 15% of its customers would purchase PCH to alleviate

lBS. This evidence is insufficient to overcome summary judgment for two reasons.

First, the fact that Bayer anticipates 15% of its customers will buy PCH to alleviate lBS

symptoms does not prove what motivates those consumers to purchase PCH. More specifically,

it is not clear whether Bayer’s marketing of PCH conveys an implied message that the product

alleviates lBS or whether consumers buy PCH believing that it helps with lBS for some other

unknown reason. Unlike the plaintiff in Mullins, Plaintiffs here did not commission an expert to

determine if PCH conveyed an implied message. Second, and more importantly, Plaintiffs do not

argue that Bayer made any false implied claims about PCH. Therefore, Bayer’s anticipation that

lBS sufferers may purchase PCH, without more, is insufficient to overcome summary judgment.1’

Plaintiffs also argue that Bayer admits in some of its internal documents that PCH “does

nothing.” P1. Opp. at 12. Some examples are from a May 2009 presentation where Bayer stated,

“[t]here is no information about [PCH’s] subspecies and thus the product” and “[t]here is noclinical support for any of the claims that we make with regard to our specific subspecies.” D.E.

144-32 at 197097. Another example is a May 2011 email where a Bayer representative asks the

Chief Sales Officer from Wakunaga whether there is any additional infonTlation to substantiate

the claims about PCH, to which the Chief Sales Officer replied, “I believe you have everything.”

D.E. 161-1 at 14359. Bayer also acknowledged that there was a “[w]eak scientific base for

[PCH] bacteria strains.” D.E. 150, Ex. 2 at 196802. These statements potentially support a lack

of-substantiation theory, but they fall short of acknowledging that Bayer’s statements about PCHare actually false or misleading. Therefore, they do not provide a basis for Plaintiffs to overcome

summary judgment.

29
IV. CONCLUSION

For the reasons set forth above, Bayer’s motion for summary judgment is granted.

Plaintiffs’ motions for class certification and to strike portions of Bayer’s expert’s opinion are

denied as moot. An appropriate Order accompanies this Opinion.

Dated: April 17, 2017

John Michael Vazquei D.J.

12 Plaintiffs’ claims for breach of the implied warranty of merchantability and unjust enrichment

fail for the same reasons as the consumer protection statutes. See Gaul v. Bayer Healthcare LLC,

No. 12-5110,2013 WL 12181778 (D.N.J. Feb. 11,2013) (dismissingNewJerseyConsumerFraud

Act, unjust enrichment, breach of express warranty, and breach of implied warranty ofmerchantability claims because the complaint failed to properly allege that a product was falsely

advertised).

30