DDS No. 14-2-3779

APRIL 30, 2014 (Date Decided)

Judge Jordan

FOR APPELLANTS: Brandon L. Bogle (argued) (Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor); Scott D. Levensten.

For Merck Sharp & Dohme Corp.: Karen A. Confoy, (Fox Rothschild).

for Barr Pharmaceuticals Inc., RP, Barr Laboratories, and Teva Pharmaceuticals USA, Inc.: John K. Crisham (Kirkland & Ellis); Glenn S. Kerner, Katherine D. Seib (Goodwin Procter); Jay P. Lefkowitz (argued) (Kirkland & Ellis); George E. McDavid (Reed Smith).

For Watson Laboratory and Watson Pharmaceuticals Inc.: Terry M. Henry (Blank Rome).

For Mylan Inc. and Mylan Pharmaceutals Inc.: Kelly E. Jones, Steven A. Stadtmauer (Harris Beach); Harvey L. Kaplan (Shook, Bardy, Bacon).

For Apotex Corp.: Charles A. Fitzpatrick, III, Arthur B. Keppel (Rawle & Henderson).

For Sun Pharma Global and Sun Pharmaceutical Industries Inc.: Jeffrey A. Cohen (Flaster Greenberg); Sandra J. Wunderlich.

For Watson Pharmaceuticals Inc. FKA Cobalt Pharmaceuticals Co. aka Watson Pharmaceuticals Inc. and Cobalt Laboratories Inc.: Terry M. Henry (Blank Rome).

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. Plaintiffs sued Merck Sharp & Dohme, Corp., the manufacturer of Fosamax®, and several entities that manufacture the generic equivalent (generic defendants). The District Court for the District of New Jersey granted judgment on the pleadings in favor of the Generic Defendants because it determined the state-law claims against them were pre-empted by federal law.

Appellants challenge only the judgment entered against them on their design-defect claims, which were held to be pre-empted. Appellants state that the claims at issue do not necessarily require the generic defendants to unilaterally change the labeling for alendronate sodium, so the generic defendants’ state-law duties do not conflict with any specific provisions of the Food Drug and Cosmetic Act (“FDCA”) and thus do not raise impossibility pre-emption. Read together, PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett establish that under the FDCA a generic drug manufacturer may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability. Thus, to the extent it is impossible for a generic drug manufacturer to comply with its duty under a state tort law unless it takes one of those actions, that law is pre-empted by the FDCA.

The generic defendants emphasized that the claims were brought under the laws of 28 different states and they could only avoid liability by taking one of the options that Mensing and Bartlett say they cannot be forced to take: (1) changing alendronate sodium’s labeling, (2) changing the drug’s design, or (3) ceasing sales of the drug altogether. In the end, appellants were forced to concede that point in effect if not in words. They tried to avoid the scope of Mensing’s reach by saying that their design-defect claims are not intended to relate to any drug warnings accompanying alendronate sodium, and they do not seek a “change” in alendronate sodium’s design which is precluded by federal law in any event. Appellants are left with their “stop-selling” theory, under which the generic defendants can only avoid state-law liability by halting their sales of alendronate sodium. However, Bartlett categorically rejected that theory, ending the argument. Appellants’ strict-liability design-defect claims are preempted.