UNITED STATES DISTRICT COURT 

DISTRICT OF NEW HAMPSHIRE 

KAREN L. BARTLETT, 

 Plaintiff, 

 v. 

MUTUAL PHARMACEUTICAL 

COMPANY, INC. and UNITED 

RESEARCH LABORATORIES, INC., 

 Defendants. 

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Case No.: 08-cv-358-JL 

Judge Joseph N. Laplante 

DEFENDANTS’ MOTION TO EXCLUDE THE TESTIMONY OF 

PLAINTIFF’S EXPERT WITNESSES 

 Pursuant to Federal Rules of Evidence 402, 403, and 702, defendants Mutual 

Pharmaceutical Company, Inc.; and United Research Laboratories, Inc., move the Court to 

exclude the proffered expert testimony of plaintiff’s expert witnesses, Randall Tackett, Ph.D., 

and Roger Salisbury, M.D., and that of plaintiff’s treating physicians to the extent their testimony 

is outside the course and scope of each witness’s care and treatment of plaintiff. 

 Neither Dr. Tackett, Dr. Salisbury nor any of plaintiff’s treating physicians are qualified 

to offer various opinions they attempt to proffer. Furthermore, the subject opinions do not 

satisfy the requirements for admissibility of expert testimony. The opinions at issue will not 

assist the trier of fact in understanding the evidence or determining a fact in issue as they are not 

based on generally accepted scientific principles or methodology, and are purely speculative. 

 This motion is supported by the accompanying memorandum and the documents 

accompanying the Declaration of Paul J. Cosgrove, filed contemporaneously herewith. 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 1 of 59
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Respectfully submitted, 

/s/ Paul J. Cosgrove 

Paul J. Cosgrove 

(OH Bar No. 0073160) 

Pro hac vice 

Joseph P. Thomas (OH Bar No. 0040379) 

Pro hac vice 

Linda E. Maichl (OH Bar No. 0042042) 

Pro hac vice 

ULMER & BERNE LLP 

600 Vine Street, Suite 2800 

Cincinnati, Ohio 45202-2409 

(513) 698-5000 

(513) 698-5001 FAX 

Stephen Judge 

(NH Bar No. 1292) 

WADLEIGH, STARR & PETERS, P.L.L.C. 

95 Market Street 

Manchester, NH 03101 

(603) 669-4140 

Attorneys for Defendants 

Mutual Pharmaceutical Company, Inc., and 

United Research Laboratories, Inc. 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 2 of 59
UNITED STATES DISTRICT COURT 

DISTRICT OF NEW HAMPSHIRE 

KAREN L. BARTLETT, 

 Plaintiff, 

 v. 

MUTUAL PHARMACEUTICAL 

COMPANY, INC. and UNITED 

RESEARCH LABORATORIES, INC., 

 Defendants. 

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Case No.: 08-cv-358-JL 

Judge Joseph N. Laplante 

MEMORANDUM IN SUPPORT OF 

DEFENDANTS’ MOTION TO EXCLUDE THE TESTIMONY OF 

PLAINTIFF’S EXPERT WITNESSES

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 3 of 59
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TABLE OF CONTENTS 

I. INTRODUCTION .............................................................................................................. 7 

II. PLAINTIFF’S EXPERT OPINIONS ................................................................................. 7 

A. Randall Tackett, Ph.D............................................................................................. 8 

B. Roger Salisbury, M.D. .......................................................................................... 13 

C. Plaintiff’s Treating Physicians.............................................................................. 16 

1. Tahsin Ergin, M.D. ................................................................................... 17 

2. Karen Mello, M.D..................................................................................... 18 

3. John T. Shulz, M.D................................................................................... 19 

4. Joel Stein, M.D. ........................................................................................ 21 

5. Claes Dohlman, M.D. ............................................................................... 22 

6. James Chodosh, M.D. ............................................................................... 23 

7. Bijan Sadrnoori, M.D................................................................................ 24 

III. LAW AND ARGUMENT ................................................................................................ 24 

A. Standard for Admissibility of Expert Testimony.................................................. 30 

B. Plaintiff’s Experts Opinions Are Not Proper Expert Testimony .......................... 31 

1. Dr. Tackett Is Attempting to Offer Impermissible Legal 

Opinions Regarding the FDCA and FDA Regulations............................. 32 

2. Dr. Salisbury Is Attempting to Offer Impermissible Legal 

Opinions.................................................................................................... 34 

3. Drs. Tackett and Salisbury Are Attempting to Offer 

Impermissible Legal Opinions Regarding Mutual’s Duty and 

Breach of that Duty................................................................................... 35 

C. The Court Must Evaluate the Expert’s Qualifications.......................................... 36 

1. Dr. Tackett Does Not Have the “Knowledge, Skill, 

Experience, Training, or Education” to Offer Opinions 

Regarding Regulatory Issues .................................................................... 36 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 4 of 59
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2. Dr. Salisbury Does Not Have the “Knowledge, Skill, 

Experience, Training, or Education” to Offer Opinions 

Regarding Regulatory Issues .................................................................... 39 

D. The Court Must Evaluate the Expert’s Methodology........................................... 40 

1. Dr. Tackett’s Opinions Are Not Admissible............................................. 42 

a. Dr. Tackett’s Opinions Are No More Than Personal 

Opinions........................................................................................ 42 

b. Dr. Tackett’s Opinions Are Unreliable......................................... 46 

2. Dr. Salisbury’s Opinions Are Not Admissible ......................................... 48 

E. The Testimony of Plaintiff’s Treating Physicians Should Be 

Excluded to the Extent such Testimony Cannot Satisfy the Daubert 

Standard. ............................................................................................................... 52 

1. Plaintiff’s Treating Physicians Have Not Been Retained to 

Develop Expert Opinions as Required by Federal Rule of 

Civil Procedure 26 and the Decisions of this Court.................................. 52 

2. Plaintiff’s Treating Physicians Must Be Precluded from 

Testifying as Experts to the Extent They Have No Opinions 

About the Cause of Plaintiff’s Condition.................................................. 54 

IV. CONCLUSION................................................................................................................. 55 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 5 of 59
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TABLE OF AUTHORITIES 

Cases

A.E. v. Indep. Sch. Dist. No. 25, 

936 F.2d 472 (10th Cir. 1991) .................................................................................................. 35 

Babcock v. GMC, 

299 F.3d 60 (1st Cir. 2002)....................................................................................................... 30 

Baker v. Dalkon Shield Claimants Trust, 

156 F.3d 248 (1st Cir. 1998)..................................................................................................... 42 

Barrett v. Atlantic Richfield Co., 

95 F.3d 375 (5th Cir. 1996) ...................................................................................................... 45 

Brown v. Best Foods, Inc., 

169 F.R.D. 385 (N.D. Ala. 1996) ............................................................................................. 53 

Bucher v. Gainey Transp. Serv., 

167 F.R.D. 387 (M.D. Pa. 1996)............................................................................................... 53

Burkhart v. Washington Metro. Area Transit Auth., 

112 F.3d 1207 (D.C. Cir. 1997)................................................................................................ 33 

Carrier v Am. Bankers Life Assur. Co., 

2007 U.S. Dist LEXIS 81395 (D.N.H. October 25, 2007) ....................................................... 32 

Cipollone v. Yale Indus. Prods., 

202 F.3d 376 (1st Cir. 2000)..................................................................................................... 30 

Daubert v. Merrell Dow Pharms., Inc., 

43 F.3d 1311 (9th Cir. 1995) .................................................................................................... 41 

Daubert v. Merrell Dow Pharms., Inc., 

509 U.S. 579 (1993).................................................................................... 30, 31, 40, 41, 45, 46 

Dinco v. Dylex, Ltd., 

111 F.3d 964 (1st Cir. 1997)..................................................................................................... 35 

General Elec. Co. v. Joiner, 

522 U.S. 136 (1997).................................................................................................................. 41 

Gomez v. Rivera Rodriguez, 

344 F.3d 103 (1st Cir. 2003)..................................................................................................... 52 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 6 of 59
iv

Hall v. Sykes, 

164 F.R.D. 46 (E.D. Va. 1995)................................................................................................. 53 

Hayes v. Douglas Dynamics, Inc., 

8 F.3d 88 (1st Cir. 1993)........................................................................................................... 32 

Healthpoint, Ltd. v. Stratus Pharms. Inc, 

2002 U.S. Dist. LEXIS 28206 (W.D. Tex., Feb. 2, 2002)........................................................ 44 

Holesapple v. Barrett, 

5 Fed. Appx. 177 (4th Cir. 2001).............................................................................................. 42 

Hypertherm, Inc. v. Am. Torch Tip Co., 

2009 U.S. Dist. LEXIS 22774 (D.N.H. Feb. 27, 2009)............................................................ 35 

In re: Baycol Prod. Liab. Litig., 

532 F. Supp. 2d 1029 (D. Minn. 2007)..................................................................................... 45 

In re: Meridia Products Liability Litigation, 

328 F. Supp. 2d 791 (N.D. Ohio 2004)............................................................................... 31, 36 

In re: Rezulin Prods. Liab. Litig., 

309 F. Supp. 2d 531 (S.D.N.Y. 2004) .................................................................... 43, 44, 45, 49 

Kumho Tire Co., Ltd. v. Carmichael, 

526 U.S. 137 (1999).................................................................................................................. 41 

Loeb v Hammond, 

407 F.2d 779 (7th Cir. 1969) .................................................................................................... 32 

Lofton v. McNeil Consumer & Specialty Pharms., 

2008 U.S. Dist. LEXIS 94391 (N.D. Tex., July 25, 2008)....................................................... 43 

McCorvey v. Baxter Healthcare Corp., 

298 F.3d 1253 (11th Cir. 2002) ................................................................................................ 31 

McNamara v. Bre-X Minerals, Ltd., 

2003 U.S. Dist. LEXIS 25641 (E.D. Tex., Mar. 31, 2003) ...................................................... 43 

Nieves-Villanueva v. Soto-Rivera, 

133 F.3d 92 (1st Cir. 1997)....................................................................................................... 32 

Norris v. Baxter Healthcare Corp., 

397 F.3d 878 (10th Cir. 2005) .................................................................................................. 41 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 7 of 59
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Powers v. Lazy Days’ R.V. Center, Inc., 

2007 U.S. Dist. LEXIS 25085 (M.D. Fla.) ............................................................................... 46 

Rider v. Sandoz Pharmaceuticals Corp., 

295 F.3d 1194 (11th Cir. 2002) ................................................................................................ 41 

Rivera v. Turabo Med. Ctr. P'ship, 

415 F.3d 162 (1st Cir. 2005)..................................................................................................... 46 

Ruiz-Troche v. Pepsi Cola of P.R. Bottling Co., 

161 F.3d 77 (1st Cir. 1998)....................................................................................................... 46 

Salas v. United States, 

165 F.R.D. 31 (W.D.N.Y. 1995)............................................................................................... 53 

Seahorse Marine Supplies, Inc. v. Puerto Rico Sun Oil Co., 

295 F.3d 68, (1st Cir. 2002)...................................................................................................... 40 

Shapardon v. West Beach Estates, 

172 F.R.D. 415 (D. Hawaii 1997)............................................................................................. 53 

Sprague v. Liberty Mut. Ins. Co., 

177 F.R.D. 78 (D.N.H. 1998) .................................................................................................. 52 

Sullivan v. Glock, Inc., 

175 F.R.D. 497 (D. Md. 1997).................................................................................................. 52 

Torres v. County of Oakland, 

 758 F.2d 147 (6th Cir. 1985) ................................................................................................... 32 

United States v. Mikutowicz, 

365 F.3d 65 (1st Cir. 2004)....................................................................................................... 32 

United States v. Sepulveda, 

15 F.3d 1161 (1st Cir. 1993), cert. denied, 114 S. Ct. 2714 (1994) ......................................... 36 

United States v. Shay, 

57 F.3d 126 (1st Cir. 1995)....................................................................................................... 42 

Vosburgh v. O’Mara, 

2008 DNH 133 (D.N.H. August 5, 2008)................................................................................. 52 

Washington v. Arapahow County Dep’t of Soc. Servs., 

197 F.R.D. 439 (D. Colo. 2000) ............................................................................................... 52

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 8 of 59
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Young v. United States, 

181 F.R.D. 344 (W.D. Tex. 1997) ............................................................................................ 53 

Statutes and Regulations

21 C.F.R. §314.3........................................................................................................................... 37 

21 U.S.C. §355(j).......................................................................................................................... 37 

Rules

Fed. R. Civ. P. 26.......................................................................................................................... 52 

Fed. R. Evid. 401 .......................................................................................................................... 42 

Fed. R. Evid. 403 .......................................................................................................................... 42 

Fed. R. Evid. 702 ........................................................................................................ 30, 31, 36, 54 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 9 of 59
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I. INTRODUCTION 

This diversity action was removed to this Court on August 29, 2008. Karen Bartlett 

suffered serious injuries from SJS/TEN following her alleged prescription use of a generic 

NSAID, sulindac. Her doctor prescribed the branded form of the drug (Clinoril) to her, but her 

pharmacy dispensed generic sulindac. (See generally First Amended Complaint.) According to 

plaintiff, defendants are liable for marketing a defective product with inadequate labeling and for 

failing to test or otherwise investigate the alleged association between sulindac and SJS/TEN. 

(Id., ¶¶ 27-33.) 

 To support her claims, plaintiff has designated two experts: Randall Tackett, Ph.D., and 

Roger Salisbury, M.D.1

 Dr. Tackett attempts to offer opinions regarding regulatory matters and 

causation. Dr. Salisbury also attempts to offer opinions regarding regulatory matters and 

causation. However, for various reasons, many of the opinions of those experts are not 

admissible. 

II. PLAINTIFF’S EXPERT OPINIONS 

 Plaintiff originally identified Robert C. Nelson, Ph.D., a former Food and Drug 

Administration (“FDA”) official, as an expert witness in regulatory affairs. However, shortly 

after that designation, plaintiff hastily withdrew him. Plaintiff was forced to withdraw 

Dr. Nelson as her regulatory expert because Dr. Nelson testified in other litigation (as an expert 

for the plaintiffs) that (1) FDA requires generic drug labeling to be the same as the branded 

company labeling; and (2) that FDA does not want generic drug companies to send FDA 

 1

 Plaintiff designated three other purported retained experts on damages as opposed to liability issues: (1) 

Stephen Pliskow, M.D., concerning the nature and extent of plaintiff’s alleged vaginal injuries, (2) Thomas Barocci, 

Ph.D., concerning lost wages and economic damages, and (3) Carol Hyland, a life care planner. To the extent 

plaintiff purports to rely on expert testimony from plaintiff’s treating physicians, that testimony is inherently 

unreliable, as explained below, due to the fact any such opinions were generated only for purposes of litigation and 

are outside each respective treating physician’s course and scope of treatment. 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 10 of 59
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scientific literature on products they sell. (See Deposition of Robert C. Nelson, Ph.D., in Gibbs 

v. Wyeth, Case No. 04-CV-235739, Jackson Cty. Cir. Ct., MO; and in Cousins v. Wyeth, Case 

No. 03:08-CV-310-N, N.D. TX (testifying generic drug companies have no ability to change 

labels to add or strengthen warnings and that FDA does not want copies of scientific literature 

submitted to individual ANDAs), Ex. 1.)2

 Without Dr. Nelson, who agrees with defendants on the key regulatory issues in this 

litigation, plaintiff is forced to rely upon her other witnesses, who simply are not knowledgeable 

in this area. 

A. RANDALL TACKETT, PH.D. 

Dr. Tackett is a pharmacologist and toxicologist. (See Report of Randall Tackett, Ph.D., 

(“Tackett Rpt.”), ¶2, Ex. 2.) Dr. Tackett is not an epidemiologist, dermatologist, immunologist, 

or allergist. (See Exhibit 1 to Tackett Rpt.) He has never been an employee of a pharmaceutical 

company or FDA. (See id.) 

 Dr. Tackett was retained by plaintiff to offer opinions regarding federal regulatory 

requirements governing generic drug manufacturers, the adequacy of sulindac labeling, and 

specific causation. Specifically, Dr. Tackett attempts to offer opinions as to proper surveillance 

activities, what Mutual knew or should have known, what actions Mutual should or could have 

taken, as well as what effects those efforts might have had. (See generally Tackett Rpt.) 

 Dr. Tackett claims to have significant knowledge regarding FDA’s regulations gained 

through his academic pursuits. (See id., ¶6-9.) Although his report states that he has made 

presentations regarding “FDA regulations in labeling and warnings,” has “reviewed federal 

 2

 All “Ex.” references are to the exhibits attached to the Declaration of Paul J. Cosgrove filed 

contemporaneously herewith, unless otherwise noted. 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 11 of 59
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regulations as they pertain to drug ... labeling issues,” taught courses involving “FDA 

regulations about ... labeling issues,” and what “FDA regulations mean and their 

interpretations,” (Id., ¶¶6, 7, 8), his deposition testimony reveals that his knowledge of those 

issues is superficial at best. (See Deposition of Randall Tackett, Ph.D., (“Tackett Dep.”), pp. 64-

66, 69, 203-205, 209-10, Ex. 3.) While Dr. Tackett may have some very fundamental 

understanding regarding federal regulations as they apply to “drug development, clinical trials, 

pharmacoepidemiology,” “pharmacology, pharmacokinetics, and basic principles of drug design 

and development” (Tackett Rpt., ¶¶6, 7), those regulations are not relevant to the issues 

presented in this case. Dr. Tackett is attempting to bootstrap whatever knowledge he has of FDA 

regulations relating to product design and development to offer opinions regarding FDA’s 

approval process for generic drugs. However, whatever experience he may have in the former 

does not qualify him to offer opinions regarding the latter. 

Unlike the former FDA officials who were deposed in this case and testified, based on 

their personal experience in FDA’s Office of Generic Drugs (“OGD”), regarding FDA’s policies 

and procedures applicable to generic drugs, Dr. Tackett has no knowledge of those policies and 

procedures. In fact, many of Dr. Tackett’s opinions are personal opinions of what he believes 

the federal regulations should require, personal opinions of the ethical and moral duties of 

pharmaceutical companies, and attempts to offer legal interpretations that are outside the 

permissible scope of expert testimony. In fact, Dr. Tackett goes so far as to cite legal case 

decisions as authority for his opinions. Dr. Tackett also improperly attempts to second-guess 

FDA’s risk/benefit analysis with regard to sulindac. 

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Dr. Tackett’s report is replete with his thoughts about what federal statutes and 

regulations provide. Dr. Tackett “believes” the requirements in 21 U.S.C. §355(j) and 21 C.F.R. 

§314.94(a)(8)(iv) that generic drug labeling be the “same as” the labeling for the reference listed 

drug (“RLD”) are “clearly directed to the labeling process only at the time that the ANDA is 

being filed.” (Id., ¶40; see also ¶75.) However, he then contends that FDA “recognized that 

there could be differences” between the generic drug’s labeling and the labeling of its RLD 

“even at the time of the submission of [the] ANDA.” (Id., ¶ 64; see also ¶77.) Dr. Tackett is not 

needed for interpretation of statutes and regulations. Indeed, it is improper for him to offer his 

interpretations of statutes and regulations. 

Dr. Tackett also believes that “[r]esponsible and ethical companies usually provide 

information that not only meets [FDA] requirements, but exceeds them in order to assure that the 

FDA has all the information it needs to monitor the safety and effectiveness of a drug product.” 

(Id., ¶25.) Yet, he offers pages of opinions that FDA is woefully understaffed and underfunded 

and does not and cannot monitor the safety and effectiveness of drug products. (Id., ¶¶ 19-27.) 

Again, these are personal views that have no place in a courtroom. 

The legal opinions Dr. Tackett attempts to offer are numerous. For example, he states 

that “[s]ince October 1, 2007, it has been the law that a drug company continues to have ‘the 

responsibility ... to maintain its label,’ including making unilateral changes to its label as new 

safety information is learned.” (Id., ¶88 (Dr. Tackett does not indicate the source of his quote, 

but presumably it is from a legal case opinion).) He also attempts to offer testimony regarding 

his interpretation of federal statutes and regulations; i.e., “21 C.F.R. §201.56 imposes an 

independent duty” (Id., ¶45); “21 C.F.R. §201.57 imposes specific requirements” (id., ¶46); 

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“federal regulations impose an affirmative duty” (id., ¶47); “defendants had [a] duty and 

obligation” to submit with the initial ANDA different warnings than those on the RLD’s label 

(id., ¶47). The instances are too numerous to list. 

Similarly, Dr. Tackett attempts to offer various legal conclusions in the guise of expert 

opinions. Specifically, he attempts to offer opinions that Mutual was negligent in various 

respects; i.e., “[i]t was negligence” for Mutual not to develop a Medication Guide (id., ¶95); 

“Mutual was negligent for failing to conduct any due diligence regarding whether they should 

initially apply for an ANDA for sulindac” (id., ¶134); “Mutual was also negligent” after 

obtaining its ANDA by “failing to remove sulindac from the market....”; (id., ¶134, see also

¶136); Mutual was “negligent for not communicating” the results of an article to FDA, not 

advocating for a label change or dear doctor letter, and not filing a citizen’s petition (id., ¶136); 

“Mutual was negligent and grossly negligent” for allegedly knowing the risks of SJS/TEN and 

“still proceeding with conscious indifference towards Karen Bartlett and others similarly situated 

to her” for a variety of reasons (id., ¶138). He also attempts to offer opinions that “defendants’ 

prescription package insert [for the] Sulindac product ... was an inadequate warning, defective, 

and misleading....” (id., ¶48); “sulindac was an unreasonably dangerous drug” (id., ¶149); and 

“defendants did not adequately warn” (Id., ¶149). During his deposition, Dr. Tackett testified 

that it is his “interpretation” that Mutual had a duty and was negligent under New Hampshire 

law. (Id., pp. 326-27.) His “interpretation” of New Hampshire law and his sole basis for his 

opinions on defendants’ “negligence” derives from his conversations with plaintiff’s counsel. 

(Tackett Dep., pp. 327-29, 331-32.) 

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Many of Dr. Tackett’s opinions regarding what Mutual should have done are based on a 

single article in the literature. According to Dr. Tackett, an article published in 2003 should have 

placed Mutual on notice that there was a far greater risk of SJS/TEN from the use of sulindac 

than from other NSAIDs. (Tackett Rpt., ¶122.) However, that article contains no data regarding 

the relative risk of developing SJS/TEN from sulindac, a fact which Dr. Tackett concedes. 

(Tackett Dep., pp. 306-07.) Instead, the authors included the minimal data relating to sulindac in 

a group with other NSAIDs that also did not have sufficient data to determine relative risk and 

calculated the relative risk for the entire group as a whole. (Id., pp. 307-08.) As Dr. Tackett 

admitted, the authors as easily could have included sulindac in a different category, which likely 

would have resulted in a different relative risk calculation, but neither calculation is valid as to 

sulindac alone. (Id., p. 308.) 

Dr. Tackett also attempts to rely on adverse events in FDA’s adverse event database as 

support for his opinions that there are significantly more reports of SJS/TEN associated with 

sulindac use than other NSAIDs and the sheer quantity of those reports should have alerted 

Mutual to a need for a labeling change. (Tackett Rpt., ¶121.) However, Dr. Tackett uses only 

raw numbers. He does not include an analysis of the reports, usage data, number of prescriptions 

written, or length of time the products have been on the market. Nor does he consider that 

Mutual had no adverse events for sulindac relating to SJS/TEN. 

Similarly, Dr. Tackett attempts to support his opinions by reference to data regarding 

Bactrim, an antibiotic, the NDA of which Mutual acquired. According to Dr. Tackett, 

information in the Bactrim NDA regarding SJS/TEN should have placed Mutual on notice of the 

need to change the sulindac labeling because both Bactrim and sulindac are sulpha-related drugs. 

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However, Dr. Tackett does not factor into his opinions that Mutual acquired the NDA for 

Bactrim in late November, 2004, and Karen Bartlett received and filled her prescription for 

sulindac only one month later. 

In addition to his initial report, Dr. Tackett has issued two supplemental reports. In his 

first supplemental report, Dr. Tackett does no more than regurgitate testimony of four treating 

physicians and gratuitously “agrees” with their conclusions. He also provides no reliable basis 

for quantifying the risk of SJS and TEN from sulindac based on the risk of SJS and TEN posed 

by a completely different drug. 

In his second supplemental report, Dr. Tackett does much the same as he did in his 

supplemental report, except in the second supplement he is regurgitating the testimony of the 

former FDA-officials. In his second supplement he also attempts to offer his interpretation of 

decisions from federal courts of appeal, as well as his belief of “congressional intent.” Further, 

he attempts to offer speculative conclusions regarding what is and is not permitted under FDA 

regulations regarding generic drugs based on documents, which in some instances are 

unidentified, regarding interactions between other pharmaceutical companies and FDA. 

B. ROGER SALISBURY, M.D. 

 In two reports and 28 pages, plaintiff’s putative expert Dr. Salisbury, like Dr. Tackett, 

purports to offer opinions on a number of topics, including: 

• General and specific causation; 

• The nature and scope of plaintiff’s alleged injuries resulting from SJS/TEN; 

• Mutual’s alleged failure to warn about the risks associated with sulindac; 

• Mutual’s alleged failure to disseminate health information to patients and the 

healthcare communities; 

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• Mutual’s failure to file a citizen’s petition, allegedly resulting in the failure to 

inform and/or underinform plaintiff’s prescribing physician; and

• Personal opinions about Mutual’s qualitative conduct and state of mind. 

(See Report of Roger Salisbury, M.D., (“Salisbury Rpt.”), pp. 5-6, Ex. 4.) 

Dr. Salisbury is a physician who specialized in burn surgery, but is now more of an 

administrator (and litigation consultant). (See Deposition of Roger E. Salisbury (“Salisbury 

Dep.”), pp. 12-15, Ex. 5.) As a burn surgeon, he claims he has had the opportunity to treat 

approximately 400 patients with SJS or TEN, and one of those 400 “maybe” (he simply is “not 

positive”) was from sulindac. (Id., p. 20.) His experience in the treatment of burn victims is of 

little consequence, however, because the care and treatment of patients who have been diagnosed 

with SJS/TEN is not an issue in this case. 

Dr. Salisbury is not a dermatologist, epidemiologist, immunologist, allergist, or 

pharmacologist. (See Salisbury CV attached to Salisbury Rpt., Ex. 4; see also Salisbury Dep., 

pp. 110-112, Ex. 5.) He has never been an employee of a pharmaceutical company, consulted 

for FDA, participated in any FDA advisory committee meetings, and has no knowledge of 

FDA’s drug safety evaluators or the Agency’s ability to evaluate SJS cases as they come into the 

agency. (See Salisbury Dep., pp. 154, 203-205.) He is not a regulatory expert. (Id., p. 147.) He 

has never spoken to any current or former FDA employees about his opinion that generic 

manufacturers can change their labels to be different from the labeling of the reference listed 

drug to determine whether those opinions comport with FDA policy. (Id., p. 211.) 

He is not familiar with and does not know what the standard of practice is for labeling of 

generic drugs in the pharmaceutical industry. (Id., pp. 155-156.) Moreover, Dr. Salisbury has 

never published any papers that address FDA’s practices and policies as they concern generic 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 17 of 59
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drug companies; he has never lectured on the topic of regulations affecting generic drugs; and 

has never been called upon to provide consulting services to generic pharmaceutical companies 

with regard to any regulatory issue about generic drugs. (Id., pp. 264-265.) He does not know 

the difference between a supplement and an amendment to an ANDA. (Id., p. 170.) He does not 

know how labeling changes are made. (Id., p. 171.) 

Indeed, he has never even expressed an opinion with regard to the labeling of generic 

drugs in writing except for expert reports in civil litigation. (Id., p. 265.) The one educational 

course that Dr. Salisbury took concerning FDA regulations for generic drugs, he took because 

plaintiff’s counsel Keith Jensen brought it to his attention and paid for him to take it during the 

course and for the purpose of his testimony in this lawsuit. (Id., pp. 265-266.) In short, 

Dr. Salisbury’s opinions did not grow naturally and directly from research and practice 

conducted independent of litigation; rather, he developed those opinions to testify in this case. 

Dr. Salisbury’s legal conclusions also are numerous. He attempts to argue that Mutual 

was negligent in multiple respects. (Salisbury Rpt., pp. 21-23.) For instance, “Mutual was 

negligent for not [conducting surveillance]” or “safety oriented due diligence regarding whether 

Mutual should initially apply for an ANDA for sulindac.” (Id., p. 19.) “Mutual is negligent for 

not taking all of these actions [i.e., actions Pfizer took with respect to a branded drug] on an 

equally and likely more dangerous drug from an SJS/TEN perspective – sulindac.” (Id., p. 20.) 

“Mutual was negligent and grossly negligent for . . . [an enumeration of 17 unsubstantiated 

duties or obligations].” (Id., pp. 21-22.) As with Dr. Tackett, virtually his entire report is filled 

with improper conclusions. 

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16

Most of Dr. Salisbury’s opinions, at least from a science perspective, are based on the 

Mockenhaupt 2003 study. Dr. Salisbury has admitted that the study provides no evidence that 

sulindac’s risk of SJS/TEN is greater than any other NSAID at the time. (See Salisbury Dep., p. 

117 (“[I]t doesn’t tell you what the relative risk was. . . .”).) 

And, in the end, Dr. Salisbury admits that the medical community has known since the 

1970s that NSAIDs can cause SJS/TEN. (Id., p. 222.) Dr. Salisbury likewise agrees that 

SJS/TEN is a hypersensitivity reaction. (Id., pp. 24-25.) He also agrees that physicians should 

read the package insert or PDR for medications they prescribe. (Id., p. 40.) And that only FDA 

has authority to require a black box warning. (Id.,, p. 134.) Indeed, Dr. Salisbury has agreed that 

Mutual’s label warned of severe skin reactions. 

Q. [] Does the sulindac label state that “severe skin reactions have occurred 

during therapy with sulindac. Fatalities have occurred in these patients”? 

A. Yes. 

(Salisbury Dep., p. 138.) 

C. PLAINTIFF’S TREATING PHYSICIANS 

This Court set September 15, 2009, as the deadline for plaintiff to comply with their Rule 

26 expert disclosures. In addition to the experts identified above, plaintiff disclosed no less than 

21 different treating physicians as non-retained purported experts. Plaintiff then continued to 

abuse the discovery process by providing many if not most of those treating physicians with 

reams of scientific literature and other materials on the eve of their depositions, and then 

attempted to solicit from them, as if on cross-examination with improper questions filled with 

argument, mischaracterizations, and misrepresentations, testimony about issues that clearly were 

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17

not in the course and scope of their treatment of the patient plaintiff. A few of those examples 

are set forth here. 

1. Tahsin Ergin, M.D. 

Before Dr. Ergin ever saw plaintiff, he was aware that SJS and TEN could be reactions to 

NSAIDs as a result of his general education as a physician. (Deposition of Tahsin Ergin, M.D., 

(“Ergin Dep.”), pp. 116-118, Ex. 6.) He prescribed Clinoril 200 mg twice daily to plaintiff for 

shoulder bursitis on December 30, 2004. (Id., p. 10.) That was the sum total of his treatment of 

plaintiff. (Id.) Notably, plaintiff’s counsel provided a declaration to Dr. Ergin well outside the 

course and scope of his treatment of plaintiff, which Dr. Ergin essentially repudiated at 

deposition.3

 He retracted the opinion framed for him by plaintiff’s counsel in his declaration that 

warnings were insufficient because the data he was provided by plaintiff’s counsel did not 

comprise a definitive scientific review and he is not an expert in the area. (Id., p. 71.) Dr. Ergin 

further testified that the information he was asked to review by plaintiff’s counsel was not 

information he had when he prescribed Clinoril in 2004, and thus was outside the course and 

scope of his treatment of plaintiff. (Id., pp. 108-109.) Further, he had not seen any of plaintiff’s 

medical records. (Id., p. 148.) In fact, none of the discussion of scientific literature offered by 

plaintiff in Dr. Ergin’s declaration and at Dr. Ergin’s deposition are related to his care and 

treatment of plaintiff. (Id., p. 113.) 

As of his August 11, 2009, deposition, including when he saw plaintiff, Dr. Ergin had not 

seen the package insert for sulindac; the package insert did not influence his prescription 

 3

The declarations plaintiff’s counsel prepared for Dr. Ergin purported to identify Dr. Ergin as declaring 

about insufficient warnings to physicians concerning the immediate withdrawal of sulindac if symptoms developed 

and that if FDA had stronger warnings about increased risk for SJS/TEN, it is highly likely he (Dr. Ergin) would 

have prescribed a different NSAID. See Exhibits 49 and 50 to Ergin Dep. 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 20 of 59
18

decision; and, did not influence what he did or did not say to plaintiff. (Id., pp. 136-137.) He is 

not an expert on epidemiology, pharmacology or dermatological reactions to NSAIDs. (Id., p. 

58.) He is not an expert in biostatistics. (Id., p. 64.) He is not an expert on who has the ability 

to change a drug label or what is required to change a label. (Id., p. 97.) He has no intent to be 

an expert witness and has not agreed to testify as an expert witness. (Id., p. 110.) He has not 

presented himself as an expert witness, has not analyzed materials from an epidemiological 

standpoint, and has not done an exhaustive review of literature. Furthermore, he does not intend 

to conduct that analysis. (Id., p. 131.) 

2. Karen Mello, M.D. 

Dr. Mello is an infectious disease specialist that treated plaintiff briefly at Tufts Medical 

Center on February 2, 2005. (See Deposition of Karen Mello, M.D., (“Mello Dep.”), p. 30, Ex. 

7.) She did not learn that plaintiff allegedly had used sulindac until her deposition. (Id., p. 38.) 

She did not learn that plaintiff’s condition had evolved to TEN until after she was discharged 

from her care. (Id., p. 81.) Plaintiff’s counsel attempted to force Dr. Mello to ratify the 

substance of a multitude of medical literature that she did not review in connection with her care 

and treatment of plaintiff. (Id., p. 102.) Dr. Mello was not aware of that literature. (Id., pp. 96-

97, 99, 100-101, 109-110.) Indeed, at least one article post-dated her treatment of plaintiff by 

four years. (Id., pp. 96-97.) Dr. Mello had not seen any of the medical records presented to her 

until her deposition, well outside the course and scope of her treatment of plaintiff. (Id., p. 127.) 

Dr. Mello has no expert opinions to offer in this case. (Id., p. 127.) While Dr. Mello may testify 

as a treating physician to those matters within the course and scope of her treatment of plaintiff, 

she was not familiar with virtually any of the records and literature plaintiff’s counsel presented 

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19

to her. Those materials and her testimony about them were contrived by counsel for purposes of 

litigation. 

3. John T. Shulz, M.D. 

Except for his discrete care and treatment of plaintiff as a burn patient, which is a 

damages issue, Dr. Shulz’s testimony is neither relevant nor reliable for any issue, as the care 

and treatment of patients who have been diagnosed with SJS/TEN is not an issue in this case. 

Dr. Shulz was a burn surgeon at Mass General Hospital (now at Bridgeport Hospital). 

(See Deposition of John T. Shulz, M.D., (“Shulz Dep.”) pp. 6-7, Ex. 8.) He treated plaintiff at 

Mass General Burn Unit intermittently from February through October, 2005. (Id., pp. 149-150.) 

As with the other treating physicians, plaintiff’s counsel supplied him with a compendium of 

medical literature and records that were not part of the course and scope of his treatment of 

plaintiff in connection with his deposition. (Id., pp. 141-142 (Q: Just so I’m clear, though, the 

articles that were provided to you were not part of the chart as you understood it; right? A: 

Correct, correct.”).) Indeed, Dr. Shulz presumed Mr. Jensen was paying for his testimony at the 

rate of $450 hour, and spent eleven hours reviewing the additional materials (not part of his 

chart) supplied by plaintiff’s counsel for his deposition, in addition to meeting with plaintiff’s 

counsel for several hours. (Id., p. 145.) Yet, no expert report was disclosed for Dr. Shulz. (See 

Plaintiffs’ Expert Witness Disclosure, Ex. 14; see also Shulz Dep., p. 145.) 

Dr. Shulz never reviewed the literature concerning SJS/TEN causation or treatment of 

SJS/TEN patients in connection with his treatment of plaintiff. (Shulz Dep., pp. 151-156.) 

Moreover, as Ms. Bartlett’s burn surgeon, Dr. Shulz disavowed any ability to testify as an expert 

on issues such as her alleged post-traumatic stress disorder. 

Q: Are you a psychiatrist? 

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20

 A: No. 

Q: Are you a psychologist? 

A: No. 

Q: Are you the person on the burn team when you’re treating a patient who 

makes a diagnosis of PTSD? 

A: No. 

Q: Are you familiar with the DSM IV criteria for PTSD? 

A: Yes, but I cannot repeat them. 

Q: Are you aware as you sit here today, one way or another, if Ms. Bartlett 

has been diagnosed with PTSD? 

A: I believe that she has been diagnosed with that or posttraumatic stress 

symptomatology. I don’t know if she’s got - - if she was diagnosed with fullblown PTSD, but I know she’s had some difficulty. 

Q: Could you point me to a record in Exhibit 133 that says that? 

A: No, but can I clarify? 

Q: Sure. 

A: It is impossible to have posttraumatic distress syndrome during the acute 

stress event, so it wouldn’t be in here. 

Q: So that’s not something that you would be in apposition to comment about 

specifically for Mrs. Bartlett as of today? 

A: No. 

Q: You’re agreeing with me? 

A: Yes, I am. 

(Id., pp. 162-163.) 

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21

 Dr. Shulz’s testimony outside the course and scope of his treatment of plaintiff was 

largely contrived for purposes of the litigation. Moreover, it appears he believes he is a retained 

expert, but has not produced any expert report. 

4. Joel Stein, M.D. 

Dr. Stein was plaintiff’s attending physician at Spaulding Rehabilitation, where she 

convalesced following her discharge from Mass General. (See Deposition of Joel Stein, M.D. 

(“Stein Dep.”), p. 12, Ex. 9.) His testimony about any issue outside the course and scope of 

plaintiff’s rehabilitation is irrelevant and unreliable. As Dr. Stein testified, “I have indicated that 

I’m not an expert in this area [i.e., causation].” (Id., p. 94.) Nonetheless, plaintiff’s counsel, as 

with practically every other physician, provided Dr. Stein with materials that were outside the 

course and scope of his treatment of plaintiff. “One was a document entitled, “What Causes 

TEN,” which is a list of references and some, what I presume are, excerpts from those papers 

Mr. Jensen provided me.” (Id., p. 103.) 

Q: Now, Dr. Stein, you may recall that we began the deposition today with a 

group of exhibits that were premarked, Exhibits 22 through 35 and identify for 

me, if you can, which ones were not, to your specific knowledge, part of your 

record at Spaulding Rehab? 

A: Sure. Exhibit 22 was not. Exhibit 23, to my knowledge, was not. Exhibit 

24 was not. Exhibit 25 was not. Exhibit 26 was not. Exhibit 27 was not. Exhibit 

28 presumably was. I don’t think I saw it in the abstract, but it typically would 

have been. Exhibit 29 most likely was not. Exhibit 30 was, again, most likely 

not. Exhibit 31 was a part of the record. Exhibit 32 was. Exhibit 33 was. 

Exhibit 34 was. And Exhibit 35 was part of the record, as well. 

 Q: For those records that you have identified as being outside of your file at 

Spaulding Rehab, would you agree with me, sir, that those records include 

observations that you did not make? 

A: Yes. 

* * * 

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Q: Did you reach any conclusion to a reasonable degree of medical or 

scientific certainty about the cause of Mrs. Bartlett’s condition? 

A: No. 

(Id., pp. 105-106, 110.) 

As Dr. Stein said, “it was not the purpose of my care to identify the cause [of her 

condition] or to take any specific other actions,” (id., p. 117), and the pharmacology of NSAIDs 

as it relates to SJS or TEN is not his area of expertise. (Id., p. 120.) Much of the testimony 

plaintiff seeks to elicit from Dr. Stein is outside the course and scope of his treatment of plaintiff. 

5. Claes Dohlman, M.D. 

Dr. Dohlman treated plaintiff’s eyes following SJS/TEN at the Mass Eye & Ear 

Infirmary. He is not an expert on SJS/TEN. (See Deposition of Claes Dohlman, M.D. 

(“Dohlman Dep.”), p. 18, Ex. 10.) The only aspect of plaintiff’s condition that interested him 

was the damage to plaintiff’s eyes, and consequently, he did not review plaintiff’s medical 

history in connection with his care and treatment of her, including her diagnosis of TEN (as 

opposed to SJS). (Id., pp. 19-20.) He cannot comment on “mechanism of action” of drug 

induced SJS/TEN as he is not an expert in biology of SJS, epidemiology, or statistical 

correlations with medications. (Id., pp. 27, 170.) All that he knows of SJS/TEN causation and 

etiology is “vague medical hearsay” (id., p. 27), and “I certainly don’t have any opinion on 

etiology. This is notoriously difficult to find [] and identify. And I have not been involved with 

her original hospitalization at MGH and so I cannot comment one way or the other.” (Id., 

p. 183). He does not know why blindness follows later in SJS cases. (Id., p. 53.) Although he 

reads the patient histories and evaluations of referring physicians in his chart, he is not “an expert 

dermatologist, or infection or inflammation scientist,” and would “rather stay away from that 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 25 of 59
23

area.” (Id., p. 162.) He has no written opinions outside of his medical record binder. (See id., 

p. 165.) He has never reviewed any labeling for sulindac, id., p. 169. He would rather not give 

expert opinions in this case, id., pp. 170-171 and thus has no opinions beyond “what [he] kn[e]w 

about the treatment of” plaintiff’s eyes and those outcomes. (See id., p. 171.) In sum, 

Q. Do you remember when you said that you were not an expert on SJS and 

that you would have very little to add to this? Do you recall that comment, sir? 

A. Well, I should -- I should say I am -- I am not an expert on the treatment 

of S – of Stevens-Johnson syndrome in general and the etiology of StevensJohnson. This is not my field. My field is ophthalmology and the ophthalmic 

consequences of Stevens-Johnson and the ophthalmic treatment. 

Q. Sure, the sequellae of Stevens-Johnson, correct? 

A. Correct. 

(Id., p. 168.) 

Much of the testimony plaintiff seeks to elicit from Dr. Dohlman is outside the course 

and scope of his treatment of plaintiff. 

6. James Chodosh, M.D. 

Dr. Chodosh also treated plaintiff at Mass Eye & Ear Infirmary. He has never been 

involved directly in the “figuring out part” of what caused SJS or TEN. (See Deposition of 

James Chodosh, M.D. (“Chodosh Dep.”), pp. 159-160, Ex. 11.) (“I am not involved in the 

determination of its cause . . . That is not my role”).) By the time patients get to him, they 

already have been told what caused their condition, (id., p. 161), and that was the case for 

plaintiff, and thus that determination was outside the course and scope of his medical treatment. 

(Id., p. 162.) In the course of his treatment of plaintiff, Dr. Chodosh never once undertook a 

search of the world’s scientific literature to ascertain and evaluate the potential causes of 

SJS/TEN. (Id., pp. 171.) Dr. Chodosh did not make any independent determination about 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 26 of 59
24

causation of plaintiff’s condition during the course and scope of his treatment of her. He merely 

propagated a note in the chart that was forwarded to him. (Id., pp. 141-143.) ([] I wasn’t present 

during that care. I didn’t prescribe it. I didn’t see her when she entered Mass General Hospital. 

So I can only go from the same records that everyone else has . . . . I can’t guarantee you 

personally that sulindac was the cause . . . ”). Much of the testimony plaintiff seeks to elicit from 

Dr. Chodosh is outside the course and scope of his treatment of plaintiff. 

7. Bijan Sadrnoori, M.D. 

Dr. Sadrnoori is a pulmonologist that treated plaintiff for the first time in October 2007 

for evaluation of respiratory distress. (See Deposition of Bijan Sadrnoori, M.D. (“Sadrnoori 

Dep.”), pp. 8-9, Ex. 12.) His testimony that plaintiff has SJS due to sulindac is not a finding that 

he made based on his care and treatment. (See id., pp. 86-87.) His testimony about a multitude 

of other issues also is irrelevant and unreliable. He is not an expert in dermatology, 

pharmacology, gastroenterology or ophthalmology. (See id., pp. 87-89.) Much of the testimony 

plaintiff seeks to elicit from Dr. Sadrnoori is outside the course and scope of his treatment of 

plaintiff for respiratory distress. 

* * * * * 

 There are multitudes of similar testimony from the litany of other treaters identified by 

plaintiffs as purported “unretained” experts. Each physician’s testimony should be limited as 

irrelevant and unreliable to the extent it proffers opinions outside the course and scope of the 

physician’s treatment of plaintiff. 

III. LAW AND ARGUMENT 

As a threshold matter, plaintiff’s retained experts Drs. Tackett, Salisbury, and Pliskow 

should be excluded because each failed to comply with Rule 26(a)(2)(B) and each failed to 

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25

comply with subpoenas served on them. Each was required to produce the data or other 

information he considered in forming his opinions. Defendants issued subpoenas duces tecum to 

plaintiff’s experts in connection with their depositions. Defendants requested all their reliance 

materials and other relevant materials such as prior depositions and reports. (See Multiple 

communications to plaintiff’s counsel, Ex. 13.) Though plaintiff’s experts are all professional 

expert witnesses, none produced a single prior deposition transcript. (See e.g., Tackett Dep., 

pp. 269-270; Salisbury Dep., pp. 10-11, 243 (“Q: Can we agree that you will provide those to 

counsel so he can provide them to us? A: Sure. Mr. Jensen: Subject to plaintiff’s objections. It 

might happen; it might not.”).) Sometime after Dr. Tackett’s deposition, plaintiff’s counsel 

produced just three prior reports, for matters which did not involve pharmaceutical product 

liability, though he testifies in these matters frequently. Dr. Salisbury and Dr. Pliskow produced 

no materials. Dr. Salisbury’s testimony is instructive: 

 Q. Did you bring with you today any prior transcripts or reports from 

other litigation? 

 A. You mean from other cases? 

 Q. Yes. 

 A. No sir. 

 * * * 

 Q. And what is the reason why you didn’t bring transcripts or reports 

from other cases? 

 A. I – I’m sorry, I saw this [the subpoena] and looked at it briefly 

yesterday . . . 

 Q. You do have transcripts and other reports that you’ve given in 

other SJS cases, is that correct? 

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26

 A. That’s correct. 

(Salisbury Dep., pp. 10-11, Ex. 5.) There is no doubt Dr. Salisbury has the requested materials, 

he simply refused to produce them, despite a subpoena. 

Moreover, each witness was supposed to “prepare his own report” as required by Rule 

26(a)(2)(B). Plaintiff cannot argue in good faith that occurred. Dr. Tackett already has admitted 

that portions of his report were prepared by counsel: 

Q: So you sent him [plaintiff’s counsel, Keith Jensen] drafts and he then sent 

them back to you? 

A: There were maybe two drafts that were forwarded, yes. 

Q: You forwarded them to him? 

A: Correct. 

Q: And then what happened? They came back to you? 

A: With some editing, yes. 

Q: [] [S]o did you look to see whether he had inserted whole paragraphs into 

your report? 

A: Yeah, there were some changes that were made. . . And I read and okayed 

them. I said, “I have no problem with these.” 

Q: So multiple paragraphs by Mr. Jensen incorporated into your report? 

A: Yes. 

(See Tackett Dep., pp. 73-74.) In fact, paragraphs 36, 37, 38 and 39 of Dr. Tackett’s report 

appear verbatim in a Motion to Take Certain Depositions After the Close of Discovery and for an 

Order Requiring Ms. Corrine Gamper to Appear[Doc. 101] plaintiff filed prior to the disclosure 

of Dr. Tackett’s report. 

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 Furthermore, it is worth noting that Dr. Tackett’s and Dr. Salisbury’s reports in some 

instances are virtually identical as shown in the table below. 

Dr. Tackett (Tackett Rpt., ¶ 138.) 

“[T]hat Mutual was negligent and grossly 

negligent for . . .” 

Dr. Salisbury (Salisbury Rpt., pp. 21-23.) 

“[T]hat Mutual was negligent and grossly 

negligent for . . .”

1) Mutual knowing that the regulations require 

them to review the adverse experience reports, 

assess them and report them to the FDA by 

virtue of the 356h form and approvable letter 

telling them to do so, and not doing so; 

1) Mutual failed to review the adverse 

experience reports, assess them and report 

them to the FDA by virtue of the 356h form 

and approvable letter telling them to do so; 

2) Mutual knowing about 314.80 and 314.81 

and that these regulations require them to 

review and to submit the scientific literature to 

the FDA based on the postmarketing reporting 

regulations, and not doing so until 2006 or 

2007 (Mutual failed to do so for 15 years); 

2) Mutual failed to review and to submit the 

scientific literature to the FDA based on the 

postmarketing reporting regulations, and not 

doing it until about 2006 (having failed to do it 

for about 15 years); 

4) Mutual knowing that 21 C.F.R. 201.57 

required the disclosure of serious adverse 

events, and then admitting that SJS and TEN 

were serious adverse events, and doing nothing 

to warn about SJS and TEN as serious adverse 

events associated with Sulindac in the warning 

section of the label; 

3) Mutual knowing that 21 C.F.R. 201.57 

required the disclosure of serious adverse 

events, and then admitting that SJS and TEN 

were serious adverse events, and doing nothing 

to warn about SJS and TEN as serious adverse 

events associated with Sulindac; 

5) Mutual knowing that the regulations require 

them to review their labeling at least annually, 

and to make sure that it was accurate, and not 

false or misleading, but not doing so; 

4) Mutual failed to review their labeling, and 

to make sure that it was accurate, and not false 

or misleading; 

7) Mutual knowing that it was important that 

labels not understate the risks associated with a 

drug when it may have affected prescribing 

decisions, and when it knew that it was not 

assessing any risks associated with Sulindac 

was reckless; 

5) Mutual knowing that it was important that 

labels not understate the risks associated with a 

drug when it may have affected whether the 

doctor prescribing decisions, and when it knew 

that it was not assessing any risks associated 

with Sulindac was unconscionable;

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 30 of 59
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Dr. Tackett (Tackett Rpt., ¶ 138.) 

“[T]hat Mutual was negligent and grossly 

negligent for . . .” 

Dr. Salisbury (Salisbury Rpt., pp. 21-23.) 

“[T]hat Mutual was negligent and grossly 

negligent for . . .”

8) Mutual knowing that labeling needs to be 

reviewed and that it changes over time, but 

didn’t review or update their label, or ensure 

that accurate safety information contained in 

their WARNINGS, PRECAUTIONS, 

INFORMATION FOR PATIENTS, or 

ADVERSE REACTIONS sections of their 

Sulindac label from 1991-2006, when they 

knew that SJS and TEN were adverse events 

associated with their product based on their 

labeling, but never doing so until 2006; 

6) Mutual failed to update their label, or 

ensure that accurate safety information 

contained in their WARNINGS, 

PRECAUTIONS, INFORMATION FOR 

PATIENTS, or ADVERSE REACTIONS 

sections of their Sulindac label from 1991-

2006, when they knew that SJS and TEN were 

adverse events associated with their product 

based on their labeling; 

10) Mutual did not submit any scientific 

literature to the FDA as part of their 

postmarketing reporting obligations, but 

assumed that the NDA holder or the FDA were 

assessing for them, despite the fact that they 

now submit such literature for Sulindac. They 

failed to specifically submit substantial and 

important literature over the course of many 

years while they marketed Sulindac; 

7) Mutual did not submit any scientific 

literature to the FDA as part of their 

postmarketing reporting obligations but 

assumed that the NDA holder or the FDA were 

assessing for them, despite the fact that they 

now submit such literature for Sulindac. They 

failed to assess and submit substantial and 

important literature over the course of many 

years while they marketed Sulindac; 

11) continuing to market (failing to suspend 

sales) of sulindac; 

8) continuing to market (failing to suspend 

sales) of sulindac; 

12) not communicating the results of 

Mockenhaupt et al. 2003, to the medical and 

patient community; 

9) not communicating the results of 

Mockenhaupt et al. 2003, to the medical and 

patient community; 

13) not advocating to the FDA for label 

changes and/or dear healthcare professional 

letters; 

10) not advocating to the FDA for label 

changes and/or dear healthcare professional 

letters; 

14) failing to file a citizen’s petition seeking 

such affirmative action; 

11) failing to file a citizen’s petition seeking 

such affirmative action (eg., including but not 

limited to dissemination of risk and safer 

alternative information to patient and medical 

communities and/or for a label change); 

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Dr. Tackett (Tackett Rpt., ¶ 138.) 

“[T]hat Mutual was negligent and grossly 

negligent for . . .” 

Dr. Salisbury (Salisbury Rpt., pp. 21-23.) 

“[T]hat Mutual was negligent and grossly 

negligent for . . .”

15) failing to advise the medical community 

and the public that safer alternatives to 

sulindac, specifically for bursitis or shoulder 

pain existed, and that they need not 

unnecessarily incur the risk of disabling ocular 

lesions, corneal melting, symblephara (fusion 

of the eyeball to the eyelid), coma, esophageal 

strictures and multiple surgeries when aspirin 

or acetaminophen were equally effective and 

far less disabling and deadly alternatives; 

12) failing to advise the medical community 

and the public that safer alternatives to 

sulindac, specifically for bursitis or shoulder 

pain existed, and that they need not 

unnecessarily incur the risk of blindness, 

corneal melting, symblephara (fusion of the 

eyeball to the eyelid), ocular lesions, coma, 

esophageal strictures and multiple surgeries 

when aspirin or acetaminophen were equally 

effective and far less disabling and deadly 

alternatives; 

16) failing to institute Pfizer-advocated actions 

to decrease SJS/TEN (on a different NSAID 

drug, Bextra, that was pulled from the market 

in large part due to SJS/TEN), including but 

not limited to a) limit use to patients who have 

failed to respond or could not tolerate other 

NSAIDs; b) requiring patient and physician 

educational efforts for more frequent and 

intense monitoring during the first 8 weeks of 

use (because prompt withdrawal of the 

offending agent is the most effective treatment 

for SCAR); c) requiring information and 

patient/physician education materials to stress 

importance of immediate discontinuation at 

first evidence of dermal and/or mucosal signs 

or symptoms; and d) work with regulatory 

authorities to assure compliance with these 

measures; 

13) failing to institute Pfizer-advocated actions 

to decrease SJS/TEN (on a different NSAID 

drug, Bextra, that was pulled from the market 

in large part due to SJS/TEN), including but 

not limited to a) limit use to patients who have 

failed to respond or could not tolerate other 

NSAIDs; b) requiring patient and physician 

educational efforts for more frequent and 

intense monitoring during the first 8 weeks of 

use (because prompt withdrawal of the 

offending agent is the most effective treatment 

for SCAR); c) requiring information and 

patient/physician education materials to stress 

importance of immediate discontinuation at 

first evidence of dermal and/or mucosal signs 

or symptoms; and d) work with regulatory 

authorities to assure compliance with these 

measures; 

17) failing to institute, circulate and require a 

patient medication guide which would advise 

patients to stop sulindac when any rash or 

fever occurred; 

14) failing to institute, circulate and require a 

patient medication guide which would advise 

patients to stop sulindac when any rash or 

fever occurred; 

18) failing to study whether the benefits of 

sulindac outweigh its risks in relation to safer 

alternative medications for the same 

indications; 

15) failing to study whether the benefits of 

sulindac outweigh its risks in relation to safer 

alternative medications for the same 

indications; 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 32 of 59
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Dr. Tackett (Tackett Rpt., ¶ 138.) 

“[T]hat Mutual was negligent and grossly 

negligent for . . .” 

Dr. Salisbury (Salisbury Rpt., pp. 21-23.) 

“[T]hat Mutual was negligent and grossly 

negligent for . . .”

20) failing to advocate that Sulindac should 

have had a “Black Box Warning” about the 

causal relationship for SJS/TEN at least by 

1991, immediately after Mutual got approval to 

market the drug, and that Mutual should have 

started to advocate for a black box warning 

both upon completion of its due diligence 

before its initial ANDA filing and after its 

generic drug was approved for sale. 

Accordingly, it is my opinion that Mutual was 

negligent for not advocating for a Black Box 

Warning and a warning regarding SJS & TEN 

containing incidence information and 

subpopulation warnings from the day it filed its 

initial ANDA through the date of approval and 

to date. 

17) failing to advocate that Sulindac should 

have had a “Black Box Warning” about the 

causal relationship for SJS/TEN at least by 

1991, immediately after Mutual got approval to 

market the drug, and that Mutual should have 

started to advocate for a black box warning 

both upon completion of its due diligence 

before its initial ANDA filing and after its 

generic drug was approved for sale. 

Accordingly, it is my opinion that Mutual was 

negligent for not advocating for a Black Box 

Warning and a warning regarding SJS & TEN 

containing incidence information and 

subpopulation warnings from the day it filed its 

initial ANDA through the date of approval and 

to date. 

Leaving aside how that could have happened when each witness presumably “proposed his own 

report,” the fact is that there reports and testimony are both fatally flawed. 

A. STANDARD FOR ADMISSIBILITY OF EXPERT TESTIMONY

Federal Rule of Evidence 702 serves as the starting point for the evaluation of expert 

testimony. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589 (1993); Cipollone v. 

Yale Indus. Prods., 202 F.3d 376, 380 (1st Cir. 2000); Babcock v. GMC, 299 F.3d 60, 67 (1st 

Cir. N.H. 2002). Rule 702 provides as follows: 

If scientific, technical, or other specialized knowledge will assist the trier of fact 

to understand the evidence or to determine a fact in issue, a witness qualified as 

an expert by knowledge, skill, experience, training, or education may testify 

thereto in the form of an opinion or otherwise. 

Fed. R. Evid. 702. 

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Trial courts, as the gatekeepers to the admission of all expert testimony, must ensure that 

improper, speculative, and unreliable opinions do not reach the jury. See Daubert, 509 U.S. at 

589 (1993). The trial court has a duty to ensure that experts are qualified and that all scientific 

testimony or evidence admitted is relevant and reliable. See id. 

 The party offering the expert has the burden of demonstrating reliability, and 

admissibility must be shown by a preponderance of the evidence. See Hypertherm, Inc. v. Am. 

Torch Tip Co., 2009 U.S. Dist. LEXIS 22774 (D.N.H. Feb. 27, 2009); see also Fed. R. Evid. 

104(a); Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 592 n.10, 113 S. Ct. 2786, 125 L. 

Ed. 2d 469 (1993). Expert testimony may be admitted only if the offering party establishes (1) 

the expert is qualified to testify regarding the matter he intends to address; (2) the methodology 

used by the expert is reliable as determined by the Daubert inquiry; and (3) the testimony will 

assist the trier of fact through the application of expertise to understand the evidence or 

determine a fact in issue. See Fed. R. Evid. 702; Daubert, 509 U.S. at 589. When a party offers 

expert testimony and the opposing party raises a Daubert challenge, the trial court must make 

certain that the expert employs in the courtroom the same level of intellectual rigor that 

characterizes the practice of an expert in the relevant field. As part of the court’s gatekeeping 

function under Rule 702, as amended to incorporate the United States Supreme Court’s opinion 

in Daubert, the court must evaluate both the scope and the content of the proposed expert’s 

testimony. See In re: Meridia Products Liability Litigation, 328 F. Supp. 2d 791, 804 (N.D. 

Ohio 2004). 

B. PLAINTIFF’S EXPERTS OPINIONS ARE NOT PROPER EXPERT TESTIMONY

 Expert witnesses are not permitted to usurp the function of the court. Witnesses are not 

permitted to offer opinions that are tantamount to legal conclusions. See United States v.

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Mikutowicz, 365 F.3d 65, 73 (1st Cir. 2004)(noting expert may not offer opinion concerning a 

legal question); Hayes v. Douglas Dynamics, Inc., 8 F.3d 88, 92 (1st Cir. 1993)(stating “expert 

opinion must be more than a conclusory assertion about ultimate legal issues”); NievesVillanueva v. Soto-Rivera, 133 F.3d 92, 99 (1st Cir. 1997) (citing Marx & Co. v. Diners’ Club, 

Inc., 550 F.2d 505 (2d Cir. 1977))(noting expert testimony on such purely legal issues is rarely 

admissible: “The danger is that the jury may think that the ‘expert’ in the particular branch of the 

law knows more than the judge – surely an impermissible inference in our system of law”); 

Carrier v Am. Bankers Life Assur. Co., 2007 U.S. Dist LEXIS 81395 (D.N.H. October 25, 

2007)(finding company’s expert, opinions merely restated law, which was province of court and 

therefore, were excluded; Torres v. County of Oakland, 758 F.2d 147, 150 (6th Cir. 

1985)(holding that expert testimony couched in terms of a “legal conclusion” is “not helpful to 

the jury”); Loeb v Hammond, 407 F.2d 779 (7th Cir. 1969)(holding expert may not testify as to 

legal effect of conduct, such as legal effect of contract, as that is matter for judge). 

1. Dr. Tackett Is Attempting to Offer Impermissible Legal Opinions 

Regarding the FDCA and FDA Regulations 

 Here, Dr. Tackett attempts to offer “opinion,” after “opinion” that in reality are attempts 

to offer purported statements of law. For instance, in his report, Dr. Tackett states that “[s]ection 

314.80 requires manufacturers of both brand name and generic drugs who hold NDAs or 

ANDAs to promptly review all adverse experience information obtained from any source (21 

C.F.R. §314.80(b)), including medical literature.” (Tackett Rpt., ¶32.) He then quotes from the 

Code of Federal Regulations, but conveniently replaces with ellipsis the applicants who are 

required to comply with the regulation. The omitted language provides that it is “[e]ach

applicant having an approved application under 314.50 or, in the case of a 505(b)(2)application, 

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an effective approved application,” who must comply with the provision. 21 C.F.R. §314.80(b). 

Both §314.50 and 505(b)(2) apply to NDAs, which are not at issue in this case. 

 Other examples of Dr. Tackett’s legal opinions include: 

• “21 C.F.R. §201.56 imposes an independent duty upon generic manufacturers to 

ensure that the labeling for their generic drugs is accurate and not false or 

misleading.” (Tackett Rpt., ¶45.) 

• “21 C.F.R. §201.57 imposes specific requirements on both innovator and generic 

drug companies for the content of the labeling for prescription drugs, ....” 

(Tackett Rpt., ¶46.) 

• “[M]anufacturers of generic drugs approved pursuant to an ANDA may alter a 

drug’s labeling ‘to add or strengthen a contraindication, warning, precaution or 

adverse reaction,’ without prior FDA approval. (21 C.F.R. 314.70(c)(6)(iii); see 

also Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994).” 

(Tackett Rpt., ¶55.) 

• “A generic drug manufacturer is expressly provided with authority to unilaterally, 

without prior FDA approval, to add warnings that ‘add or strengthen a 

contraindication, warning, precaution, or adverse reaction,’ through a Changes 

Being Effected-CBE. (21 C.F.R. §314.70(c)(6)(iii)).” (Tackett Rpt., ¶57.) 

• “21 U.S.C. §355(G)(2)(a)(v) [sic], the statutory provision on which Mutual may 

rely, by its terms applies only to the generic manufacturer’s original abbreviated 

new drug application, submitted to gain initial market approval, not to postapproval labeling supplements.” (Tackett Rpt., ¶75.) 

 Every one of those and the numerous other similar opinions Dr. Tackett attempts to offer 

infringes on the Court’s territory. As noted by the District of Columbia Circuit Court of Appeals 

“[e]ach courtroom comes equipped with a ‘legal expert,’ called a judge, and it is his or her 

province alone to instruct the jury on the relevant legal standards.” Burkhart v. Washington 

Metro. Area Transit Auth., 112 F.3d 1207, 1213 (D.C. Cir. 1997). Dr. Tackett should not be 

permitted to offer testimony regarding law, especially given that many of his “legal opinions” do 

not properly reflect the law. 

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2. Dr. Salisbury Is Attempting to Offer Impermissible Legal Opinions 

 Dr. Salisbury, likewise, is attempting to offer legal opinions. In fact, Dr. Salisbury 

confirmed that his sole purpose is to render legal opinions. He admitted that he has no 

knowledge of FDA’s practices and procedures. (See Salisbury Dep., pp. 155-156, Ex. 5)(“I don’t 

know the standard of practice in the pharmaceutical industry, what the - - I - - I can’t answer 

that”).) However, he does purport to know the law. He “believes” he knows “FDA practices and 

procedures [] for the labeling of generic drugs” from having “read the Hatch-Waxman Act.” 

(Id., pp. 1533-54.) He similarly “believes” he “understood the intent of the Hatch-Waxman Act” 

and has “read the final rules and regulations.” (Id.) However, he admits he does not know the 

“inner workings of the FDA.” (Id.) 

Q: [] I’m asking you if you would have first hand knowledge of FDA 

practices and procedures within the agency, what they do, what they allow, what 

they permit, not based upon regulations or anything, but based on knowledge of 

the operations of the Food and Drug Administration. 

A: I only know what the rules are, what the regs are, what the - - what the 

regs are. I do not know the inner workings of the FDA. 

(Id., pp. 153-154, Ex. 5.) 

 The distinction here, between testimony about FDA’s or a company’s standards and 

practices on the one hand as opposed to the law on the other, is a subtle but important one. 

Plaintiff’s experts attempt to usurp this Court’s role and discuss the law. They have no choice 

because they do not know and are not familiar with the relevant standards or practices, i.e., the 

“inner workings” of the FDA and generic pharmaceutical industry, as Dr. Salisbury put it. 

Ironically, plaintiff’s counsel has cemented that admission by objection repeatedly to the 

questions put to both Dr. Tackett and Dr. Salisbury on those issues as “legal conclusions.” In 

other words, they have opined on purely legal issues where it is impermissible for them to do so 

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and they have refused to opine on industry practices and procedures (which neither is qualified to 

do), where they must do so if they are going to provide admissible testimony. 

3. Drs. Tackett and Salisbury Are Attempting to Offer Impermissible 

Legal Opinions Regarding Mutual’s Duty and Breach of that Duty 

 Although Rule 704 of the Federal Rules of Evidence has relaxed the prohibition of 

experts offering opinions regarding ultimate issues in a case, it does not permit an expert to tell a 

jury what conclusion to reach. The First Circuit Court of Appeals has noted that although the 

“bar on “ultimate issue” opinions has been abolished in civil cases, Fed. R. Evid. 704(a); [] that 

is not a carte blanche for experts to substitute their views for matters well within the ken of the 

jury.” Dinco v. Dylex, Ltd., 111 F.3d 964, 973 (1st Cir. 1997) (citing United States v. Duncan,

42 F.3d 97, 101 (2d Cir. 1994)). 

 Other courts likewise acknowledge that expert testimony that “invades the province of 

the jury to find facts and that of the court to make ultimate legal conclusions,” must be excluded. 

Hypertherm, Inc. v. Am. Torch Tip Co., 2009 U.S. Dist. LEXIS 22774 (D.N.H. Feb. 27, 2009). 

So, even though an expert witness may testify in the form of an opinion that embraces an 

ultimate issue in the case, the witness “may not apply the law to the facts of the case to form 

legal conclusions.” A.E. v. Indep. Sch. Dist. No. 25, 936 F.2d 472 (10th Cir. 1991) (citing United 

States v. Jensen, 608 F.2d 1349, 1356 (10th Cir. 1979)). 

 It is patently improper for Drs. Tackett and Salisbury to offer opinions that Mutual was 

“negligent” or “grossly negligent.” Those issues are solely for the jury’s consideration and 

determination. 

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C. THE COURT MUST EVALUATE THE EXPERT’S QUALIFICATIONS

In performing the gatekeeping role with regard to the scope of an expert’s testimony, the 

district court must determine whether the expert witness is qualified and has specialized 

knowledge that will “assist the trier of fact to understand the evidence or to determine a fact in 

issue.” Fed. R. Evid. 702. See also United States v. Sepulveda, 15 F.3d 1161, 1183 (1st Cir. 

1993) (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 591 (1993), cert. denied, 114 

S. Ct. 2714 (1994)); In re: Meridia, 328 F. Supp. 2d at 804 (noting district court must ensure 

“the actual testimony does not exceed the scope of the expert’s expertise, which if not done can 

render testimony unreliable under Rule 702”)(quoting Wheeling Pittsburgh Steel Corp. v. 

Beelman River Terminals, Inc., 254 F.3d 706, 715 (8th Cir. 2001)); Marquardt v. Joseph, No. 

98-5163, 1999 WL 196569 (6th Cir. Mar. 30, 1999)(stating “if a trial court allows an expert to 

testify beyond her expertise it failed to perform its gatekeeping function under the Daubert

case”). 

Plaintiff’s experts Drs. Tackett and Salisbury have no opinions to offer the jury on issues 

involving regulatory affairs, FDA practices and procedures, or industry standards. They have no 

specialized knowledge in those areas. 

1. Dr. Tackett Does Not Have the “Knowledge, Skill, Experience, 

Training, or Education” to Offer Opinions Regarding Regulatory 

Issues 

Dr. Tackett attempts to provide expert opinions regarding a host of regulatory issues. 

Generally speaking, those opinions fall into two categories. First, he wants to opine regarding 

Mutual’s alleged statutory and regulatory duties. Second, he wants to opine as to what he 

believes FDA would have done had Mutual taken certain actions that he claims were required by 

statute or FDA’s regulation. 

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However, Dr. Tackett has never held a position at a pharmaceutical company or FDA and 

has never had any responsibility for pharmacovigilance. (See Tackett Rpt., CV, Ex. 2.) 

Furthermore, his deposition testimony reveals how little Dr. Tackett actually knows about the 

FDCA and FDA provisions about which he attempts to offer “opinions.” 

Dr. Tackett demonstrated his unfamiliarity with relevant FDA regulations and 

terminology during his deposition. According to Dr. Tackett, an “applicant” is the “initial 

person” who submits a drug application. (Tackett Dep., pp. 202-203.) After the application is 

approved, Dr. Tackett believes they are designated as the “sponsor.” (Id., p. 203.) In reality, the 

term “applicant” is defined in FDA’s regulations as “any person who submits an application or 

abbreviated application or an amendment or supplement to them ... to obtain FDA approval of a 

new drug or an antibiotic drug and any person who owns an approved application or abbreviated 

application.” 21 C.F.R. §314.3. 

Similarly, Dr. Tackett has no idea what an amendment to an NDA or ANDA is, or what a 

supplement to an NDA or ANDA is. (Tackett Dep., p. 204.) He testified that a supplement is 

submitted when the applicant is requesting a “new indication,” and specifically admitted that he 

has no idea what an amendment to an application is. (Id., p. 204, 205.) Then he testified that 

some distinction exists between a supplement to an ANDA and a “supplemental ANDA.” 

According to Dr. Tackett, “if they [ANDA holders] need to do clinical studies, they have to put 

an SANDA [supplemental ANDA] out.” (Id., p. 205.) However, the FDCA provisions 

applicable to generic drug companies specifically exempt them from conducting clinical studies 

and in fact, FDA may not approve even a suitability petition under 21 U.S.C. §355(j)(2)(C) if 

clinical studies are required. See 21 U.S.C. §355(j)(2)(C)(i). Furthermore, there is no difference 

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in the FDCA or FDA regulations between a “supplement’ to an ANDA “ and a “supplemental 

ANDA.” 

Dr. Tackett likewise was completely unaware of FDA’s policy regarding the submission 

of ANDAs, amendments to ANDAs, and supplements to ANDAs. (Tackett Dep., pp. 209-210, 

212.) However, he agreed that an ANDA manufacturer is required to include a certification with 

every supplement making a labeling change that the “proposed labeling is the same as the 

labeling of the reference listed drug.” (Id., p. 215.) He also agreed that it was impossible for a 

generic drug manufacturer to submit a labeling supplement making the required certification and 

at the same time submit proposed labeling that differed from the RLD labeling. (Id., p. 216.) 

Yet, he offers to opine that generic drug manufacturers are free to change label language at any 

time, even before they obtain approval. According to Dr. Tackett, ANDA holders “[t]o start off 

with [] do have to have [the certification that the labeling is the same as the RLD labeling]. But 

if you’re making a labeling change, it will -- you can change a generic without the change in the 

RLD.” (Id., p. 218.) His testimony not only is contradictory, but also is nonsensical. 

Furthermore, while Dr. Tackett opines regarding notifications he believes Mutual should 

have provided to FDA, he has no idea how adverse event reports submitted by generic drug 

companies are handled. (Id., p. 64.) Dr. Tackett believes that when OGD receives adverse event 

reports from generic drug manufacturers, it send the reports to the RLD manufacturer and to 

FDA’s department of pharmacovigilance. (Id., p. 65.) He was completely unaware that OGD 

has a policy and procedure specifically addressed to the handling of adverse event reports 

received by OGD. (Id., pp. 64-66.) After being presented with a copy of OGD’s policy and 

procedure from FDA’s Manual of Policies and Procedures (“MAPP”) addressed to adverse 

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events reported to OGD, which does not provide that a copy of adverse events be sent to the 

RLD manufacturer, Dr. Tackett back-pedaled and testified, “I misspoke.” (Id., p. 69.) 

When reviewed as a whole, it becomes abundantly clear that Dr. Tackett has a cursory 

knowledge of FDA regulations gleaned from some source. His responses during deposition 

show that he was guessing at responses and then attempted to clarify his responses when shown 

actual FDA documents or regulations. Dr. Tackett simply does not have the knowledge, training, 

or experience regarding FDA regulatory provisions applicable to generic drugs to qualify him to 

offer opinions regarding those issues. Dr. Tackett’s qualifications fall woefully short of the 

requirements of Rule 702, and he should not be permitted to testify as a “regulatory expert.” 

2. Dr. Salisbury Does Not Have the “Knowledge, Skill, Experience, 

Training, or Education” to Offer Opinions Regarding Regulatory 

Issues 

When we turn to Dr. Salisbury, we find many of the same deficiencies as with 

Dr. Tackett. Dr. Salisbury is not qualified by knowledge, skill, experience, training, or education 

to opine as to compliance or lack thereof with any regulations promulgated by FDA. Included in 

Dr. Salisbury’s opinions are the following: 

• Mutual’s alleged failure to warn about the risks associated with sulindac; 

• Mutual’s alleged failure to disseminate health information to patients and the 

healthcare communities; 

• Mutual’s failure to file a citizen’s petition, allegedly resulting in the failure to 

inform and/or underinform plaintiff’s prescribing physician; and

• personal opinions about Mutual’s qualitative conduct and state of mind. 

(See Salisbury Rpt., pp. 5-6, 21-23, Ex. 4.) 

At his deposition, Dr. Salisbury as much as admitted that he is not a regulatory expert. 

(Salisbury Dep., p. 147, Ex. 5.) He read the relevant regulations three or four years ago. (Id., 

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p. 149.) Most of what he relied on in this case was provided to him by plaintiff’s counsel. (See, 

e.g., id., pp. 274-275.) He has never worked for FDA. (Id., pp. 154, 203, 205.) He has never 

published regarding FDA regulations as they relate to pharmaceuticals. (Id., pp. 264-265.) He 

has never served on an FDA advisory committee, and has never worked for a pharmaceutical 

company. (Id., pp. 154, 203.) It appears that his only substantive experience regarding FDA 

regulations is connected to his litigation testimony and his involvement in a Citizen’s Petition 

concerning ibuprofen.4

 (Id., p. 203.) From that limited exposure, Dr. Salisbury thinks he is 

somehow qualified to testify regarding FDA regulations, sulindac’s labeling, and Mutual’s 

corporate conduct. In sum, Dr. Salisbury is a paid advocate, not an FDA or regulatory expert. 

He has no grounds for claiming expertise with respect to generic pharmaceuticals. 

D. THE COURT MUST EVALUATE THE EXPERT’S METHODOLOGY

In addition to qualifications, the court must examine the purported expert’s methodology. 

The Supreme Court has identified various factors to assist courts in evaluating whether a 

particular methodology is reliable. Daubert, 509 U.S. at 593-94. Those factors include whether 

the methods can or has been tested, whether the theory has been subject to peer review and 

publication, the known or potential rate of error, and whether the methods are generally accepted 

in the scientific community. Id. See also Seahorse Marine Supplies, Inc. v. Puerto Rico Sun Oil 

Co., 295 F.3d 68, 80 (1st Cir. 2002) (noting Daubert factors to assist the court in determining 

admissibility of expert testimony). Other factors courts have considered include whether an 

 4

 The Citizen’s Petition was a document prepared by Dr. Salisbury and six other petitioners (many of which 

are and were retained plaintiff’s experts in the litigation concerning ibuprofen. The Citizen’s Petition requested that 

FDA take a variety of action with respect to ibuprofen products. In its response to the Citizen’s Petition, the FDA – 

topic by topic – rejected numerous allegations and requests in the Citizen’s Petition. For example, Dr. Salisbury 

testified as follows: 

 Q: Now, with regard to your citizen’s petition, the FDA rejected the idea of a black box warning, right? 

 A: That’s correct. 

(Salisbury Dep., p. 134, Ex. 5.) 

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expert has properly accounted for alternative explanations, Kumho Tire Co., Ltd. v. Carmichael, 

526 U.S. 137, 154-55 (1999), whether the conclusions were reasoned as carefully as they would 

have been outside litigation, Norris v. Baxter Healthcare Corp., 397 F.3d 878, 886 (10th Cir. 

2005), and whether an accepted premise is being extrapolated to unfounded claims, General 

Elec. Co. v. Joiner, 522 U.S. 136, 144-46 (1997). 

“Conclusions and methodology are not entirely distinct from one another.” Joiner, 522 

U.S at 146. The court must examine the expert’s conclusions to determine whether they reliably 

follow from the facts known to the expert and the methodology used. See Rider v. Sandoz 

Pharmaceuticals Corp., 295 F.3d 1194, 1197 (11th Cir. 2002). In so doing, a court may exclude 

expert testimony when there is “simply too great an analytical gap between the data and the 

opinion proffered.” Id., quoting Joiner, 522 U.S. at 146. 

In order for an opinion to be admitted, the expert must show that the conclusions “have 

been subjected to normal scientific scrutiny through peer review and publication,” or explain 

how those conclusions were reached and identify “some objective source . . . to show that [the 

expert has] followed the scientific method, as it is practiced by (at least) a recognized minority of 

scientists in [the expert’s] field.” Daubert v. Merrell Dow Pharms., Inc. (Daubert II), 43 F.3d 

1311, 1318-19 (9th Cir. 1995). A proffered expert may not simply self-validate the reliability of 

his or her testimony. “Nothing in either Daubert or the Federal Rules of Evidence requires a 

district court to admit opinion evidence which is connected to existing data only by the ipse dixit

of the expert.” Joiner, 522 U.S. at 146. An expert’s methodology must be consistent with the 

accepted methods and procedures relevant to the expert’s discipline, and not merely founded on 

subjective belief or unsupported speculation. See Daubert, 509 U.S. at 592. 

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Finally, to be admissible, evidence must be relevant; and its unfair prejudicial effects can 

not substantially outweigh its probative value. See Fed. R. Evid. 401, 403; Baker v. Dalkon 

Shield Claimants Trust, 156 F.3d 248, 252 (1st Cir. 1998). Courts enjoy reasonable discretion in 

determining whether evidence, although relevant, should be excluded because its probative value 

is “substantially” outweighed by the potential to confuse or mislead the jury. See United States 

v. Shay, 57 F.3d 126, 132 (1st Cir. 1995). 

1. Dr. Tackett’s Opinions Are Not Admissible 

a. Dr. Tackett’s Opinions Are No More Than Personal Opinions 

Even if Dr. Tackett possessed the qualifications to offer testimony related to FDA’s 

regulatory practices, he is not doing so here. When he is not trying to give legal opinions or 

legal conclusions, the opinions he offers are personal opinions regarding alleged “ethical” or 

moral obligations of Mutual or drug manufacturers in general and regarding Mutual’s motives, 

state of mind, and asserted knowledge. (See, e.g., Tackett Rpt., ¶¶ 17-20, 25, 95, 134, 136, 138, 

Ex. 2.) Such “opinions” are not admissible. They are not based on any objective data. 

 Rather, Dr. Tackett’s opinions are his personal beliefs which he attempts to pass off as an 

“expert opinion.” Courts exclude opinions that are connected to data only by the ipse dixit of 

the expert. See McLain, 401 F.3d 1244, citing Joiner, 522 U.S. at 147; see also Holesapple v. 

Barrett, 5 Fed. Appx. 177 (4th Cir. 2001) ( holding “[i]t is a requirement that the expert opinion 

evidence be connected to existing data by something more than the ‘it is so because I say it is so’ 

of the expert”). “The trial court’s gatekeeper function requires more than simply taking the 

expert’s word for it.” McLain, 401 F.3d 1244. 

 The bases for Dr. Tackett’s opinions that Mutual’s pharmacovigilance was inadequate are 

pure ipse dixit. Dr. Tackett claims Mutual should have monitored the world’s literature for 

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reports of adverse events associated with sulindac, as well as other products with similar 

chemical structures. Similar proffered testimony by Dr. Tackett recently was held inadmissible. 

See Lofton v. McNeil Consumer & Specialty Pharms., 2008 U.S. Dist. LEXIS 94391 (N.D.Tex., 

July 25, 2008). In Lofton, Dr. Tackett sought to assert opinions, inter alia, regarding the 

defendant drug manufacturers’ “ethical obligations, motive, state of mind, asserted knowledge, 

and alleged conduct concerning Motrin’s history and FDA labeling requirements.” The 

magistrate judge hearing a Daubert challenge to that testimony held those opinions were 

inadmissible. 

The statements are often conclusory and unsupported by evidence; they also 

exceed the scope of the experts’ scientific, technical, and specialized 

knowledge . . . . Dr. [Tackett] testified that Defendants were negligent in several 

respects, such as failing to disclose safety information, failing to provide an 

adequate warning label, and failing to notify health professionals regarding the 

degree of risk of SJS/TEN. Under Daubert these statements are not reliable 

because there is no explanation of the reasoning or methodology underlying what 

appear to be personal opinions or legal conclusions based on Defendants’ alleged 

behavior. The statements therefore are inadmissible. See 509 U.S. at 590. 

Additionally, the submission of the personal view of [Dr. Tackett] as expert 

testimony supplants the roles of counsel in making argument at trial and the role 

of the jury in interpreting the evidence. 

Lofton, 2008 U.S. Dist. LEXIS 94931 at *20-21.5

 See also In re: Rezulin Prods. Liab. Litig., 309 

F. Supp. 2d 531 (S.D.N.Y. 2004) (holding testimony regarding ethical obligations of 

pharmaceutical companies inadmissible as subjective belief); McNamara v. Bre-X Minerals, 

Ltd., 2003 U.S. Dist. LEXIS 25641 (E.D. Tex., Mar. 31, 2003) (holding proffered expert opinion 

concerning alleged ethical violations inadmissible because it amounted to an interpretation of 

law); Healthpoint, Ltd. v. Stratus Pharms. Inc, 2002 U.S. Dist. LEXIS 28206 at *13, 23, 27 

 5

 The magistrate judge in Lofton did permit Dr. Tackett to testify regarding the FDA regulatory process, 

finding that Dr. Tackett had experience with FDA labeling requirements. See Lofton, 2008 U.S. Dist. LEXIS 94931 

at *27-28. However, it is unclear whether the defendants in that case obtained from Dr. Tackett or presented to the 

court testimony regarding Dr. Tackett’s more-limited FDA experience that Mutual obtained in this case. 

Case 1:08-cv-00358-JL Document 142 Filed 03/23/10 Page 46 of 59
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(W.D. Tex., Feb. 2, 2002) (granting motion to strike opinions regarding “any matter involving 

the FDCA or FDA regulation,” such as whether the products in question were entitled to 

“grandfather status” under the FDCA, whether FDA considers the products generic, or FDA 

requirements for safety and efficacy). 

 Other courts also have excluded similar opinions. The MDL court’s opinion in the 

prescription drug Rezulin cases is particularly applicable to the proposed testimony here. See In 

re Rezulin Prod. Liab. Litig., 309 F. Supp. 2d 531 (S.D.N.Y. 2004). The court observed “experts 

should not be permitted to ‘supplant the role of counsel in making argument at trial, and the role 

of the jury in interpreting the evidence.’” Id. at 541 (citing Primavera Familienst ng v. Askin,

130 F. Supp. 2d 450, 527, amended on reconsideration on other grounds, 137 F. Supp. 2d 438 

(S.D.N.Y. 2001)). The Rezulin Court excluded testimony of several experts offered on various 

subjects, including: (1) the defendant acted in an unethical manner; (2) the defendant’s motive, 

intent and state of mind; (3) the defendant’s conduct as measured against FDA regulations; 

(4) the history of the product; and (5) alleged suppression of research. In re Rezulin, 309 F. 

Supp. 2d at 542-51. Fundamentally, the court concluded the proposed testimony on these 

subjects was not helpful, not reliable, not relevant, or was unfairly prejudicial. The court found 

that evidence of the history of the product, to the extent admissible, “is properly presented 

through percipient witnesses and documentary evidence,” id. at 551, and the offered testimony 

“does no more than counsel for plaintiff will do in argument, i.e. propound a particular 

interpretation of [defendant]’s conduct.” Id. The court also decided that, to the extent the expert 

testimony related to the factual accuracy of the defendant’s submissions to the FDA, it 

constituted lay matter that the fact-finder could understand without expert assistance. Id. at 549. 

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Finally, the court excluded expert testimony concerning suppression of research because “it is for 

counsel to make the arguments about the significance of [defendant’s] conduct or omissions with 

respect to its researchers and not for an expert to testify as to whether the company did or did not 

do something.” Id. at 554. 

 Similarly, in consolidated cases involving prescription drug Baycol, the court considered 

admissibility of expert testimony on the question of a pharmaceutical defendant’s state of mind 

and ethics. In re: Baycol Prod. Liab. Litig., 532 F. Supp. 2d 1029 (D. Minn. 2007). Citing In re 

Rezulin, the court held “[p]ersonal views on corporate ethics and morality are not expert 

opinions.” Id. at 1053. The court also ruled “expert testimony that is merely speculation or pure 

conjecture based on the expert’s impressions of the physical evidence must be excluded as not 

based on any reliable methodology or scientific principle.” Id. (citing J.B. Hunt Transport, Inc. 

v. Gen. Motors Corp., 243 F.3d 441, 444-45 (8th Cir. 2001)). 

 Dr. Tackett intends to offer exactly the sort of testimony the Rezulin and Baycol courts 

held inadmissible. Under the guise of expertise, those opinions are no more than attempt to 

make plaintiff’s closing argument. His testimony should be excluded. 

 The second aspect of Dr. Tackett’s regulatory opinions – that FDA might have taken 

certain actions (e.g., changed the sulindac label) had Mutual provided an analysis of the 

scientific literature – is no more than pure speculation on his part, not any form of reliable expert 

testimony. 

 To be admissible, a proffered expert’s opinion must be “more than speculative belief or 

unsupported speculation.” Daubert, 509 U.S. at 590; Barrett v. Atlantic Richfield Co., 95 F.3d 

375, 382 (5th Cir. 1996) (upholding exclusion of expert testimony where it “would consist of 

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unsupported speculation”). Overall “possibility, speculation, and surmise” is insufficient to 

support expert testimony regarding causation. See Rivera v. Turabo Med. Ctr. P'ship, 415 F.3d 

162, 168 (1st Cir. 2005)( jury normally cannot find causation based on mere speculation and 

conjecture; expert testimony is generally essential); Ruiz-Troche v. Pepsi Cola of P.R. Bottling 

Co., 161 F.3d 77, 81 (1st Cir. 1998) (expert testimony must impart “scientific knowledge” rather 

than guesswork). Mere conjecture does not satisfy the standard for general acceptance. 

 The word “knowledge” in Rule 702 of the Federal Rules of Evidence connotes more than 

subjective belief or unsupported speculation. See Daubert, 509 U.S. at 590. An expert’s opinion 

must be disregarded when that opinion is based on speculation and would not assist the jury to 

understand evidence or determine a fact at issue. See Powers v. Lazy Days’ R.V. Center, Inc., 

2007 U.S. Dist. LEXIS 25085 *9-10 (M.D. Fla.). 

 Neither plaintiff nor Dr. Tackett has any evidence that FDA would have approved a label 

change for sulindac as Dr. Tackett speculates. Clearly, Dr. Tackett’s “expert testimony” is no 

more than personal opinions and uninformed guesswork. Such testimony is not helpful to the 

jury and must be excluded. 

b. Dr. Tackett’s Opinions Are Unreliable 

Finally, Dr. Tackett’s opinions are unreliable and not based on acceptable methodology. 

According to Dr. Tackett, an article published in 2003 (“Mockenhaupt 2004”)6 should have 

placed Mutual on notice that there was a far greater risk of SJS/TEN from the use of sulindac 

than from other NSAIDs. (Tackett Rpt., ¶122, Ex. 2.) However, that article contains no data 

regarding the relative risk of developing SJS/TEN from sulindac, a fact which Dr. Tackett 

 6

Mockenhaupt, M., Kelly,, J.P., Kaufman, D., et al. The Risk of SJS and TEN in Association with 

Nonsteroidal Anti-Inflammatory Drugs: A Multinational Perspective. J. Rheumatol 2003:30: 2234-2240.. 

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concedes. (Tackett Dep., pp. 306-07, Ex. 3.) Accordingly, it contains no data from which one 

can conclude that the risk of SJS/TEN was greater for sulindac than for other NSAIDs. In fact, 

the authors has such limited data on sulindac that they included the minimal data relating to 

sulindac in a group with other NSAIDs that also did not have sufficient data to determine relative 

risk and calculated the relative risk for the entire group as a whole. (Id., pp. 307-08.) As 

Dr. Tackett admitted, the authors as easily could have grouped sulindac with different drugs, 

which likely would have resulted in a different relative risk calculation, but neither calculation is 

valid as to sulindac alone. (Id., p. 308.) Defendant’s expert on pharmacoepidemiology, 

Dr. Valuck, explains that reliance on Mockenhaupt 2003 for the proposition that sulindac 

presents any greater risk of SJS/TEN than any other NSAID is not scientifically valid. (Valuck 

Dep., p. 3.) 

Dr. Tackett also attempts to rely on adverse events in FDA’s adverse event database as 

support for his opinions that there are significantly more reports of SJS/TEN associated with 

sulindac use than other NSAIDs and the sheer quantity of those reports should have alerted 

Mutual to a need for a labeling change. (Tackett Rpt., ¶121.) However, Dr. Tackett uses only 

raw numbers. He does not include an analysis of the individual reports, usage data, number of 

prescriptions written, or length of time the products have been on the market. Nor does he 

consider that Mutual had no adverse events for sulindac relating to SJS/TEN. Instead, he makes 

the remarkable assertion that Mutual should have obtained from FDA the data already in FDA’s 

possession and subject to FDA’s analysis and that Mutual then presumably should have 

reanalyzed that same data and sent it back to FDA. Curiously, Dr. Tackett would have every 

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manufacturer of every generic drug repeat that burdensome and redundant process with little 

concern for its utility or impact on FDA. 

Similarly, Dr. Tackett attempts to support his opinions by reference to data regarding 

Bactrim, an antibiotic, the NDA of which Mutual acquired. According to Dr. Tackett, 

information in the Bactrim NDA regarding SJS/TEN should have placed Mutual on notice of the 

need to change the sulindac labeling because both Bactrim and sulindac are sulpha-related drugs. 

However, Dr. Tackett does not factor into his opinions that Mutual acquired the NDA for 

Bactrim in late November, 2004, and Karen Bartlett received and filled her prescription for 

sulindac only one month later. Further, Dr. Stern, a world-renowned authority on SJS/TEN 

explains the short-sightedness of the notion that one could come to reasoned conclusions about 

the risk of SJS/TEN from sulindac based on data on Bactrim, a completely unrelated antibiotic. 

(See generally Stern Supplemental Rept.) 

A single article and a total number of adverse events allegedly reported with respect to a 

particular drug over an unknown number of years, based on an unknown number of prescriptions 

simply cannot form the basis for a reliable expert opinion that a company had any particular 

knowledge or should have taken some particular action. 

2. Dr. Salisbury’s Opinions Are Not Admissible 

 Dr. Salisbury’s report is replete with unfounded rhetoric about Mutual’s alleged conduct 

under the FDA’s regulations. Among other alleged shortcomings, Dr. Salisbury claims that 

Mutual failed to review adverse experience reports; failed to report relevant literature to FDA; 

failed to review its labeling; failed to update its label. (See Salisbury Rpt., pp. 21-23.) Those 

opinions are not reliable, not helpful, improperly invade the province of the jury, and do not 

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satisfy Rule 702 or Daubert’s requirements. Any potential probative value is far outweighed by 

the potential for confusion or undue prejudice under Rule 403. 

As noted, the court in In re Rezulin Prod. Liab. Litig., 309 F. Supp. 2d at 541, observed 

that “experts should not be permitted to ‘supplant the role of counsel in making argument at trial, 

and the role of the jury in interpreting the evidence.” Fundamentally the court held that proposed 

expert testimony construing FDA regulations and commenting on a pharmaceutical company’s 

adherence to those regulations was unreliable and thus inadmissible in products liability actions 

against pharmaceutical companies. Id. at 549. Specifically, the court noted that because the 

experts in the question disavowed expertise on the subject of FDA regulations, “[t]he proffer 

opinions on FDA standards and regulations therefore are inherently unreliable.” 

 Like Dr. Tackett, Dr. Salisbury is offering his own personal opinions regarding alleged 

“ethical” or “public health” obligations of Mutual or drug manufacturers in general and 

regarding Mutual’s motives, state of mind, and asserted knowledge. (See, e.g., Salisbury Report, 

pp. 23-27, Ex. 4.) Under the guise of expertise, those opinions are no more than another attempt 

to make plaintiff’s closing argument. Such “opinions” are not admissible. They are not based on 

any objective data. The bases for Dr. Salisbury’s opinions that Mutual’s pharmacovigilance was 

inadequate are pure ipse dixit. Dr. Salisbury claims Mutual should have monitored the world’s 

literature for reports of adverse events associated with sulindac, as well as other products with 

similar chemical structures. 

Furthermore, the inherent unreliability of Dr. Salisbury’s testimony is evidenced 

repeatedly in his testimony. As with Dr. Tackett, Dr. Salisbury purports to offer the opinion that 

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generic pharmaceutical companies are obliged to unilaterally seek changes in the form of their 

products’ labeling, however, Dr. Salisbury’s knows the contrary is true: 

Q: So the FDA would not permit the change absent a corresponding change 

by the NDA holder, correct? 

[Objection: Calls for speculation, legal conclusion, beyond his report.] 

Q: Is that your understanding having read this document? 

A: Yes. 

Q: [] And are you aware of any circumstances where the FDA would permit 

or ever has permitted a change to a generic drug label absent a corresponding 

change to the NDA holder’s product? 

[Objection: Compound. The first question calls for a legal conclusion. The 

second question is vague.] 

A: I’m not aware. 

(Salisbury Dep., p. 182, Ex. 5.) 

Dr. Salisbury’s opinion that FDA might have taken certain actions (e.g., changed the 

sulindac label) had Mutual provided an analysis of the scientific literature – is no more than pure 

speculation on his part, not any form of reliable expert testimony. Dr. Salisbury in effect also 

claims that Mutual could have and should have sent “Dear Doctor” letters to prescribing 

physician concerning sulindac. (Salisbury Rpt., pp. 22-23, Ex. 4.) However, he knows that there 

is no basis for that opinion. 

Q: [] [A]re you aware of any guidance for Dear Doctor letters that applies to 

generic drugs? 

A: That’s what I was looking for, and I can’t seem to find it. 

Q: [] Are you aware that there is one that applies to branded drugs? 

A: Yes. 

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Q: And you think you might have one that applies to generic drugs? 

A: No, I didn’t say that. 

Q: I though you were looking for it? 

A: No, I was looking for one for prescription - - branded drugs. 

* * * 

Q: The question is whether you are aware of a guidance for generic drugs 

with respect to Dear Doctor letters, Dear Healthcare Professional letters? 

A: I’m not aware of a guidance. 

(Salisbury Dep., pp. 214-215, Ex. 5.) 

 Dr. Salisbury’s opinions gain in the telling. Indeed, he purports to cite an example of a 

generic company that sent an alleged “Dear Doctor” letter, but then as much as conceded it was a 

promotional piece, which according to him had the same effect as a Dear Doctor letter. (Id., pp.

216-217.) He then agreed that FDA “worked with the innovator, Ortho-McNeil, in correcting 

the problem,” not the generic company at issue. (Id., p. 217.) All his testimony in this regard 

was based on material supplied to him by Mr. Jensen, not his independent investigation. (Id., 

p. 218.) 

 Neither plaintiff nor Dr. Salisbury has any evidence that FDA would have approved a 

label change for sulindac as Dr. Salisbury speculates. Clearly, Dr. Salisbury’s “expert 

testimony” is no more than personal opinions and uninformed guesswork. Such testimony is not 

helpful to the jury and must be excluded. 

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E. THE TESTIMONY OF PLAINTIFF’S TREATING PHYSICIANS SHOULD BE 

EXCLUDED TO THE EXTENT SUCH TESTIMONY CANNOT SATISFY THE DAUBERT 

STANDARD. 

1. Plaintiff’s Treating Physicians Have Not Been Retained to Develop 

Expert Opinions as Required by Federal Rule of Civil Procedure 26 

and the Decisions of this Court 

Federal Rule of Civil Procedure 26(a)(2) applies to all witnesses retained to provide 

expert testimony. The Rule requires a party to disclose the identity of experts who may be used 

to present evidence under Rules 702, 703, or 705 of the Federal Rules of Evidence. Fed. R. Civ. 

P. 26(a)(2)(A). The disclosing party also must produce a written report prepared and signed by 

the retained expert containing “a complete statement of all opinions to be expressed and the basis 

and reasons therefor.” Fed. R. Civ. P. 26(a)(2)(B). 

Otherwise, a treating physician may only testify to causation, diagnosis, and prognosis, so 

long as the opinion derives from the course of treatment. See Sprague v. Liberty Mut. Ins. Co., 

177 F.R.D. 78, 80 (D.N.H. 1998); Gomez v. Rivera Rodriguez, 344 F.3d 103, 113 (1st Cir. 

2003)(recognizing the course and foundation of treating physician’s testimony must be “based on 

the personal knowledge acquired before any litigation had begun”); Vosburgh v. O’Mara, 2008 

DNH 133 (D.N.H. August 5, 2008)(treating physician may only offer opinion on causation if it 

was formed during examination and treatment of plaintiff); Sullivan v. Glock, Inc., 175 F.R.D. 

497, 501 (D. Md. 1997)(holding a treating physician may testify to “the extent that the source of 

the facts which form the basis for a treating physician’s opinions derive from information learned 

during the actual treatment of the patient -- as opposed to being subsequently supplied by an 

attorney involved in litigating a case involving the condition or injury); Washington v. Arapahow 

County Dep’t of Soc. Servs., 197 F.R.D. 439, 442 (D. Colo. 2000)(holding a treating physician 

may offer expert testimony concerning matters if based on his or her observations during course 

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of treating party designating them); Shapardon v. West Beach Estates, 172 F.R.D. 415, 417 (D. 

Hawaii 1997)(noting “[t]he relevant question is whether these treating physicians acquired their 

opinions as to the cause of the plaintiff’s injuries directly through their treatment of the 

plaintiff”); Salas v. United States, 165 F.R.D. 31, 33 (W.D.N.Y. 1995)(same); Brown v. Best 

Foods, Inc., 169 F.R.D. 385, 388 (N.D. Ala. 1996)(holding treating physicians may testify to 

opinions formed during treatment); Bucher v. Gainey Transp. Serv., 167 F.R.D. 387, 390 (M.D. 

Pa. 1996)(holding treating physicians may testify to opinions on causation if they are based on 

examination, diagnosis, and treatment); Hall v. Sykes, 164 F.R.D. 46, 48 (E.D. Va. 1995)(holding 

opinions about causation and prognosis that are based on treatment are admissible). 

Young v. United States, 181 F.R.D. 344, 345 (W.D. Tex. 1997) is particularly well 

reasoned. In that case, plaintiff attempted to designate her treating physicians as both fact and 

expert witnesses. The court stated, “[a]s applied to the medical profession, these discovery rules 

mean that a treating physician generally must be considered an ordinary fact witness, and should 

not be considered an expert unless the physician has been specifically retained to develop an 

expert opinion.” Id. at 346 (citing Salas v. United States, 165 F.R.D. 31, 33 (W.D.N.Y. 1995)) 

(emphasis in the original). The Court held that the plaintiff in Young improperly designated her 

treating physicians as experts because they were not retained to provide expert opinions. Id.

Plaintiff has designated almost all her treating physicians as purported expert witnesses. 

(See Plaintiff’s Designation of Expert Witnesses.) Assuming arguendo that those doctors have 

any opinions to offer, plaintiff’s designation of them as experts for matters outside the course and 

scope of their treatment without any accompanying written report stating the bases and reasons 

for their opinions, as required by Rule 26(a)(2)(B), is improper. As demonstrated by the 

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testimony above, virtually every treating physician was provided with materials and asked 

questions about matters outside the course and scope of their treatment for which no report was 

provided. Those treating physician cannot testify as experts about those issues unless they have 

been specifically retained and provided a report. Simply put, if they were not retained, they 

attempt to go way outside the course and scope of their medical treatment of plaintiff, and if they 

were retained, they failed to produce any report. Rule 26(a)(2)(B) requires all retained experts 

to produce a report. Since plaintiff has not provided the required reports, none of plaintiff’s 

treating physicians should be permitted to testify about matters outside the course and scope of 

their treatment of plaintiff. 

2. Plaintiff’s Treating Physicians Must Be Precluded from Testifying as 

Experts to the Extent They Have No Opinions About the Cause of 

Plaintiff’s Condition 

Federal Rule of Evidence 702 allows a designated expert to testify as to his opinion if it 

“will assist the trier of fact to understand the evidence or to determine a fact in issue.” By 

definition, proposed expert testimony should include an opinion, and to be admissible it must 

meet the requirements of Rule 702 and Daubert. Without an opinion to offer, a designated 

expert is no different than a fact witness. 

Most of plaintiff’s treating physicians have no opinion as to the cause of plaintiff’s 

condition. Indeed, at least one physician that saw plaintiff at the outset of her condition failed to 

elicit a history of her use of sulindac, during the course and scope of her treatment, and was thus 

unaware that plaintiff allegedly had used sulindac until her deposition, and thus could form no 

opinion in the course of her treatment about the matter. Furthermore, at their depositions, 

virtually every doctor specifically acknowledged they had come to no independent conclusion as 

to whether plaintiff’s ingestion of sulindac played any role in her condition. In other situations, 

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plaintiff’s treating physicians have admitted that the testimony sought to be elicited by plaintiff’s 

counsel on matters such as causation and damages are well beyond their expertise and their 

respective treatment of plaintiff. Their designations as experts are improper, and they must be 

stricken. At the very least, every treating physician should be limited to testimony that is based 

on that physician’s treatment of plaintiff. 

IV. CONCLUSION 

For the foregoing reasons, defendants request the Court grant their Motion. 

Respectfully submitted, 

/s/ Paul J. Cosgrove ____ 

Paul J. Cosgrove 

(OH Bar No. 0073160) 

Pro hac vice 

Joseph P. Thomas 

(OH Bar No. 0040379) 

Pro hac vice 

Linda E. Maichl 

(OH Bar No. 0042042) 

Pro hac vice

ULMER & BERNE LLP 

600 Vine Street, Suite 2800 

Cincinnati, Ohio 45202-2409 

(513) 698-5000 

(513) 698-5001 FAX 

pcosgrove@ulmer.com

jthomas@ulmer.com

lmaichl@ulmer.com 

Stephen Judge 

(NH Bar No. 1292) 

WADLEIGH, STARR & PETERS, P.L.L.C. 

95 Market Street 

Manchester, NH 03101 

(603) 669-4140 

Attorneys for Defendants 

Mutual Pharmaceutical Company, Inc., and 

United Research Laboratories, Inc. 

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CERTIFICATE OF SERVICE

 I hereby certify that on this 23rd day of March 2010, a true and correct copy of the 

foregoing document was electronically filed with the Clerk of Court using the ECF system, and 

notice of the filing was given via electronic notice to the following: 

Christine M. Craig 

P.O. Box 977 

140 Washington Street 

2nd Floor 

Dover, NH 03821-0977 

ccraig@shaheengordon.com 

Keith M. Jensen 

Bryan Ballew 

JENSEN, BELEW & GONZALEZ, PLLC 

1024 N. Main Street 

Fort Worth, TX 76164 

kj@kjensenlaw.com 

/s/ Paul J. Cosgrove ____

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