Meta-Analysis in Pharmaceutical Cases

The Third Edition of the Reference Manual on Scientific Evidence attempts to cover a lot of ground to give the federal judiciary guidance on scientific, medical, and statistical, and engineering issues.  It has some successes, and some failures.  One of the major problems in coverage in the new Manual is its inconsistent, sparse, and at points out-dated treatment of meta-analysis.   See The Treatment of Meta-Analysis in the Third Edition of the Reference Manual on Scientific Evidence” (Nov. 14, 2011).

As I have pointed out elsewhere, the gaps and problems in the Manual‘s coverage are not “harmless error,” when some courts have struggled to deal with methodological and evaluative issues in connection with specific meta-analyses.  SeeLearning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011).

Perhaps the reluctance to treat meta-analysis more substantively comes from a perception that the technique for analyzing multiple studies does not come up frequently in litigation.  If so, let me help dispel the notion.  I have collected a partial list of drug and medical device cases that have confronted meta-analysis in one form or another.  In some cases, such as the Avandia MDL, a meta-analysis was a key, or the key, piece of evidence.  In other cases, meta-analysis may have been treated more peripherally.  Still, there are over 20 pharmaceutical cases in the last two decades that have dealt with the statistical techniques involved in meta-analysis.  In another post, I will collect the non-pharmaceutical cases as well.


Aredia – Zometa

Deutsch v. Novartis Pharm. Corp., 768 F. Supp. 2d 420 (E.D.N.Y. 2011)



In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011)

Avon Pension Fund v. GlaxoSmithKline PLC, 343 Fed.Appx. 671 (2d Cir. 2009)



In re Baycol Prods. Litig., 532 F.Supp. 2d 1029 (D. Minn. 2007)



Daubert v. Merrell Dow Pharm., 43 F.3d 1311 (9th Cir. 1995) (on remand from Supreme Court)

DePyper v. Navarro, 1995 WL 788828 (Mich.Cir.Ct. 1995)



Vinitski v. Adler, 69 Pa. D. & C.4th 78, 2004 WL 2579288 (Phila. Cty. Ct. Common Pleas 2004)


Celebrex – Bextra

In re Bextra & Celebrex Marketing Sales Practices & Prod. Liab. Litig., 524 F.Supp.2d 1166 (2007)

E5 (anti-endotoxin monoclonal antibody for gram-negative sepsis)

Warshaw v. Xoma Corp., 74 F.3d 955 (1996)


Excedrin vs. Tylenol

McNeil-P.C.C., Inc. v. Bristol-Myers Squibb Co., 938 F.2d 1544 (2d Cir. 1991)


Fenfluramine, Phentermine

In re Diet Drugs Prod. Liab. Litig., 2000 WL 1222042 (E.D.Pa. 2000)



In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164 (S.D.N.Y. 2009)



In re Gadolinium-Based Contrast Agents Prod. Liab. Litig., 2010 WL 1796334 (N.D. Ohio 2010)



In re Neurontin Marketing, Sales Pracices, and Products Liab. Litig., 612 F.Supp.2d 116 (D. Mass. 2009)


Paxil (SSRI)

Tucker v. Smithkline Beecham Corp., 2010 U.S. Dist. LEXIS 30791 (S.D.Ind. 2010)


Prozac (SSRI)

Rimberg v. Eli Lilly & Co., 2009 WL 2208570 (D.N.M.)



In re Seroquel Products Liab. Litig., 2009 WL 3806434 *5 (M.D. Fla. 2009)


Silicone – Breast Implants

Allison v. McGhan Med. Corp., 184 F.3d 1300, 1315 n. 12 (11th Cir. 1999)(noting, in passing that the district court had found a meta-analysis (the “Kayler study”) unreliable “because it was a re-analysis of other studies that had found no statistical correlation between silicone implants and disease”)

Thimerosal – Vaccine

Salmond v. Sec’y Dep’t of Health & Human Services, 1999 WL 778528 (Fed.Cl. 1999)

Hennessey v. Sec’y Dep’t Health & Human Services, 2009 WL 1709053 (Fed.Cl. 2009)



In re Trasylol Prods. Liab. Litig., 2010 WL 1489793 (S.D. Fla. 2010)



Merck & Co., Inc. v. Ernst, 296 S.W.3d 81 (Tex. Ct. App. 2009)
Merck & Co., Inc. v. Garza, 347 S.W.3d 256 (Tex. 2011)


X-Ray Contrast Media (Nephrotoxicity of Visipaque versus Omnipaque)

Bracco Diagnostics, Inc. v. Amersham Health, Inc., 627 F.Supp.2d 384 (D.N.J. 2009)


E.R. Squibb & Sons, Inc. v. Stuart Pharms., 1990 U.S. Dist. LEXIS 15788 (D.N.J. 1990)(Zestril versus Squibb’s competing product,


Zoloft (SSRI)

Miller v. Pfizer, Inc., 356 F.3d 1326 (10th Cir. 2004)



Senju Pharmaceutical Co. Ltd. v. Apotex Inc., 2011 WL 6396792 (D.Del. 2011)



In re Zyprexa Products Liab. Litig., 489 F.Supp.2d 230 (E.D.N.Y. 2007) (Weinstein, J.)

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