United States Third Circuit

In state-law tort actions brought against drug manufacturers of antidepressants known as selective serotonin reuptake inhibitors ("SRRIs") based on a theory that the drugs' labeling failed to warn the risk of increased suicidal tendencies, the circuit court finds that the underlying failure-to-warn claims under state law conflicted with, and were thus preempted by FDA's regulatory actions pursuant to its authority under the Federal Food, Drug, and Cosmetic Act.

Appellate Information

• Argued 12/10/2007
• Decided 04/08/2008
• Published 04/08/2008

Judges

• Before:  SLOVITER, AMBRO, Circuit Judges, and RESTANI , Judge.

Court

• United States Third Circuit

Counsel

• For Appellant:
  
• Harris L. Pogust, Derek T. Braslow (Argued), T. Matthew Leckman, Pogust & Braslow, Conshohocken, PA, Attorneys for Appellant, No. 06-3107., M. Karen Thompson, Norris, McLaughlin & Marcus, Somerville, NJ, Malcolm E. Wheeler (Argued), Wheeler, Trigg & Kennedy Denver, CO, Attorneys for Appellant, No. 06-5148., Allison Zieve, Public Citizen Litigation Group Washington, DC, Attorney for Amicus-Appellants Public Citizens Litigation Group, Trial Lawyers for Public Justice and Association of Trial Lawyers of America, No. 06-3107., Shanin Specter, David J. Caputo, Charles L. Becker (Argued), Kline & Specter, Philadelphia, PA, Attorneys for Amicus-Appellant Pennsylvania Trial Lawyers Association, No. 06-3107., Frederick S. Longer, Arnold Levin, Matthew C. Gaughan, Levin, Fishbein, Sedran & Berman, Philadelphia, PA, Attorneys for Amicus-Appellants Michael H. Alderman, Jerry Avorn, Lisa Bero, Elizabeth A. Boyd, Adriane Fugh-Berman, and Curt D. Furberg, No. 06-3107., Arnold A. Vickery, Vickery & Waldner, Houston, TX, Attorney for Amicus-Appellants Steve Hulley, Richard A. Kronmal, Kirby Lee, Arthur A. Levin, Bruce M. Psaty, Wayne Ray, Jacquelyn Giles and Annabel Dobbs, No. 06-3107.


• For Appellees:
  
• Charles A. Fitzpatrick, III, Arthur B. Keppel (Argued), Rawle & Henderson, Philadelphia, PA, Attorneys for Appellee Apotex Corp., Apotex Corp. as Subsidiary of Apotex, No. 06-3107., Chilton D. Varner (Argued), Andrew T. Bayman, Erica M. Long, S. Samuel Griffin, King & Spalding, Atlanta, GA, Joseph E. O'Neil, Lavin, O'Neil, Ricci, Cedrone & DiSipio, Philadelphia, PA, Attorneys for Appellee Smithkline Beecham, d/b/a GlaxoSmithKline, No. 06-3107., Gregory S. Spizer, Sol H. Weiss (Argued), Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, Philadelphia, PA, Attorneys for Appellee Beth Ann McNellis, No. 06-5148., Michael A. Galpern, Law Offices of Gene Locks, Cherry Hill, NJ, Attorney for Amicus-Appellees Association of Trial Lawyers of America-New Jersey, No. 06-5148., Kenneth S. Geller, Mayer, Brown, Rowe & Maw, Washington, DC, Attorney for Amicus-Appellees Product Liability Advisory Council, Inc., No. 06-3107., Robert N. Weiner, Jeffrey L. Handwerker, Arnold & Porter, Washington, DC, Attorneys for Amicus-Appellees Pharmaceutical Research and Manufacturers of America, No. 06-3107., Michael X. Imbroscio, Covington & Burling Washington, DC, Attorney for Amicus-Appellees American Tort Reform Association, No. 06-3107., Douglas N. Letter, Sharon Swingle (Argued), United States Department of Justice, Washington, DC, Attorneys for Amicus-Appellee United States, No. 06-3107.