American Bar Association
Media Alerts
Media Alerts - In re: Fosamax Products - Third Circuit
Decrease font size
Increase font size
May 12, 2014
  In re: Fosamax Products - Third Circuit
Headline: Third Circuit concludes that federal law pre-empts state design defect and strict liability claims

Area of Law: Federal Preemption

Issue(s) Presented: Whether state law claims against Generic Defendants in a products liability case were pre-empted by federal law?

Brief Summary:
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. ("Merck"), the manufacturer of Fosamax, as well as several entities that manufacture the generic equivalent (the "Generic Defendants"). The district court 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 that order as final under Federal Rule of Civil Procedure 54(b), and a number of the plaintiffs then appealed. The Third Circuit affirmed.

Significance (if any):

Extended Summary (if applicable):
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 district court 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 that order as final under and a number of the plaintiffs then appealed. The Third Circuit affirmed.

Plaintiffs brought state law product liability claims under theories of design defect, failure-to-warn, negligence, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, and negligent misrepresentation. This action was centralized by the U.S. Judicial Panel on Multidistrict Litigation in the U.S. District Court for the District of New Jersey. The Generic Defendants moved for judgment on the pleadings, arguing that the plaintiffs' claims were pre-empted by federal law under the Supremacy Clause of the United States Constitution. The district court concluded that the claims against the Generic Defendants were pre-empted because, just as those defendants could not lawfully change drug labeling for alendronate sodium, they also could not lawfully change the active ingredient design of the drug either. The district court then dismissed all of the Generic Defendants from the case.

Plaintiffs argued that their negligence-based design-defect claims were grounded on the theory that the Generic Defendants were negligent "because of their failure to properly analyze the drug to discover the product's defects and for negligently continuing to sell the drug after they were, or should have been aware, that it was defectively designed. The Generic Defendants argued that plaintiffs waived this argument by raising it for the first time in their reply brief. The Third Circuit agreed. The Court has consistently held that an argument is waived unless it is raised in the party's opening brief. Thus, plaintiffs' reply brief arguments, which were outside of anything addressed in the opening brief, were waived.

The Supremacy Clause of the U.S. Constitution provides that federal law shall be the supreme law of the land. There are three circumstances for when a state law is pre-empted by federal law: (1) when a federal statute includes "an express provision for pre-emption;" (2) "[w]hen Congress intends federal law to 'occupy the field'" in an area of law; or (3) when a state and federal statute are in conflict. Two recent Supreme Court opinions hold that certain state law claims against manufacturers of generic drugs directly conflict with federal law and are pre-empted. The Court explained 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." Drager, 741 F.3d at 476. Thus, state tort law is pre-empted by the FDCA. Because there was nothing the Generic Defendants could have done to change the labeling or the drug, plaintiffs' strict liability design-defect claims were pre-empted. The Third Circuit, thus, affirmed the district court's decision. A copy of the Court's opinion can be found here: http://www2.ca3.uscourts.gov/opinarch/122250p.pdf

Panel (if known): Jordan, Vanaskie, and Greenberg, Circuit Judges

Argument (if known): December 18, 2013

Date of Issued Opinion: April 30, 2014

Docket Number: 12-2250

Decided: April 30, 2014

Case Alert Author: Alexandra Perry

Counsel (if known):
Brandon L. Bogle, Esq. [ARGUED]
Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor
316 S. Baylen Street, Suite 600
Pensacola, FL 32502

Scott D. Levensten, Esq.
1420 Walnut Street, Suite 801
Philadelphia, PA 19102
Counsel for Appellants

Karen A. Confoy, Esq.
Fox Rothschild
997 Lenox Dr.
Princeton Pike Corporate Center, Bldg. 3
Lawrenceville, NJ 08648
Counsel for Merck Sharp & Dohme Corp.

John K. Crisham, Esq.
Kirkland & Ellis
655 15th St., N.W., Suite 1200
Washington, DC 20005

Glenn S. Kerner, Esq.
Katherine D. Seib, Esq.
Goodwin Procter
620 Eighth Avenue
The New York Times Bldg.
New York, NY 10018

Jay P. Lefkowitz, Esq. [ARGUED]
Kirkland & Ellis
601 Lexington Ave.
New York, NY 10022

George E. McDavid, Esq.
Reed Smith
136 Main Street, Suite 250
Princeton, NJ 08540
Counsel for Barr Pharmaceuticals Inc., RP,
Barr Laboratories, and Teva Pharmaceuticals USA,
Inc.

Terry M. Henry, Esq.
Blank Rome
130 N. 18th Street
One Logan Square
Philadelphia, PA 19103
Counsel for Watson Laboratory and
Watson Pharmaceuticals Inc.

Kelly E. Jones, Esq.
Steven A. Stadtmauer, Esq.
Harris Beach
One Gateway Center , Suite 2500
Newark, NJ 07102

Harvey L. Kaplan, Esq.
Shook, Bardy, Bacon
2555 Grant Bldg.
Kansas City, MO 64108
Counsel for Mylan Inc. and
Mylan Pharmaceuticals Inc.

Charles A. Fitzpatrick, III, Esq.
Arthur B. Keppel, Esq.
Rawle & Henderson

1339 Chestnut Street, The Widener Bldg.
One South Penn Square, 16th Floor
Philadelphia, PA 19107
Counsel for Apotex Corp.

Jeffrey A. Cohen, Esq.
Flaster Greenberg
1810 Chapel Ave. West
Cherry Hill, NJ 08002

Sandra J. Wunderlich, Esq.
Stinson Leonard Street
7700 Forsyth Blvd., Suite 1100
St. Louis, MO 63105
Counsel for Sun Pharma Global and
Sun Pharmaceutical Industries Inc.

Terry M. Henry, Esq.
Blank Rome
130 N. 18th St.
One Logan Square
Philadelphia, PA 19103

Author of Opinion: Jordan, Circuit Judge

Case Alert Circuit Supervisor: Professor Mary E. Levy

    Posted By: Susan DeJarnatt @ 05/12/2014 01:09 PM     3rd Circuit  

FuseTalk Enterprise Edition - © 1999-2018 FuseTalk Inc. All rights reserved.

Discussion Board Usage Agreement

Back to Top