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In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II)

United States Court of Appeals, Third Circuit

April 30, 2014

IN RE: FOSAMAX (ALENDRONATE SODIUM) PRODUCTS LIABILITY LITIGATION (NO. II) PATRICK WELCH, et. al, Appellants

Argued December 18, 2013

On Appeal from the United States District Court for the District of New Jersey (D.C. No. 3-11-cv-3045; MDL No. 2243 and 3-08-cv-00008) District Judge: Hon. Joel A. Pisano

Brandon L. Bogle, Esq. [ARGUED] Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor Scott D. Levensten, Esq. Counsel for Appellants

Karen A. Confoy, Esq. Fox Rothschild Counsel for Merck Sharp & Dohme Corp.

John K. Crisham, Esq. Kirkland & Ellis Glenn S. Kerner, Esq. Katherine D. Seib, Esq. Goodwin Procter Jay P. Lefkowitz, Esq. [ARGUED] Kirkland & Ellis George E. McDavid, Esq. Reed Smith Counsel for Barr Pharmaceuticals Inc., RP, Barr Laboratories, and Teva Pharmaceuticals USA, Inc.

Terry M. Henry, Esq. Blank Rome Counsel for Watson Laboratory and Watson Pharmaceuticals Inc.

Kelly E. Jones, Esq. Steven A. Stadtmauer, Esq. Harris Beach Harvey L. Kaplan, Esq. Shook, Bardy, Bacon Counsel for Mylan Inc. and Mylan Pharmaceuticals Inc.

Charles A. Fitzpatrick, III, Esq. Arthur B. Keppel, Esq. Rawle & Henderson Counsel for Apotex Corp.

Jeffrey A. Cohen, Esq. Flaster Greenberg Sandra J. Wunderlich, Esq. Stinson Leonard Street Counsel for Sun Pharma Global and Sun Pharmaceutical Industries Inc.

Terry M. Henry, Esq. Blank Rome Counsel for Watson Pharmaceuticals Inc., fka Cobalt Pharmaceuticals Co., aka Watson Pharmaceuticals Inc. and Cobalt Laboratories Inc.

Before: JORDAN, VANASKIE and GREENBERG, Circuit Judges

OPINION

JORDAN, Circuit Judge

This case involves product liability claims by individuals who allegedly suffered bone fractures because they took Fosamax® – a drug used to treat or prevent osteoporosis and Paget's Disease – or the generic equivalent of that drug, alendronate sodium. Those plaintiffs sued Merck Sharp & Dohme, Corp. ("Merck"), the manufacturer of Fosamax®, as well as several entities that manufacture the generic equivalent (the "Generic Defendants"). The United States District Court for the District of New Jersey granted judgment on the pleadings in favor of the Generic Defendants because it determined that the state-law claims against them were pre-empted by federal law. The District Court certified the finality of that order pursuant to Federal Rule of Civil Procedure 54(b), and a number of the plaintiffs have appealed. For the reasons that follow, we will affirm.

I. Background

A. Statutory and Regulatory Background[1]

The Food, Drug, and Cosmetic Act ("FDCA"), ch. 675, 52 Stat. 1040 (codified as amended at 21 U.S.C. § 301 et seq.), provides the framework for federal regulation of prescription drugs in the United States. Under the FDCA, a manufacturer must seek approval from the United States Food and Drug Administration ("FDA") to market a new drug and, in doing so, must first file a New Drug Application ("NDA") and then prove the drug's safety and efficacy and propose accurate and adequate labeling. 21 U.S.C. ยง 355(b)(1), (d). As the Supreme Court has recognized, "[m]eeting those ...


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