United States Third Circuit

The Court affirmed summary judgment for defendants, finding that plaintiff's state common law claims were premepted by the Food Drug and Cosmetic Act, 21 U.S.C. section 360k(a), because plaintiff's success on her state law claims would be in direct conflict with the FDA's determination that the product was suitable for use.

Appellate Information

• Argued 12/11/2003
• Decided 07/20/2004
• Published 07/20/2004

Judges

• GARTH, Circuit Judge., Before AMBRO, FUENTES, and GARTH, Circuit Judges.

Court

• United States Third Circuit

Counsel

• For Appellant:
  
• Allison Zeive (Argued), Public Citizen Litigation Group, Washington, John M. Humphrey, Rieders, Travis, Mussina, Humphrey, Harris, Waters & Waffenschmidt, Williamsport, for Appellant Barbara E. Horn., Douglas Letter, Appellate Litigation Counsel, Peter R. Maier, Attorney, Civil Division, Department of Justice, Washington, for Amicus Curiae United States of America., Robert N. Weiner, Arnold & Porter, Washington, for Amicus Curiae Product Liability Advisory Council, Inc., Daniel G. Jarcho, McKenna Long & Aldridge LLP, Washington, for Amicus Curiae Chamber of Commerce of the United States of America.


• For Appellees:
  
• Gary A. Winters, Mayer, Brown, Rowe & Maw, Washington, Alan E. Untereiner (Argued), Robbins, Russell, Englert, Orseck & Untereiner LLP, Washington, Charles W. Rubendall, II, Keefer, Wood, Allen & Rahal, Harrisburg, Arnd N. von Waldow, Reed Smith, Pittsburgh, for Appellee Thoratec Corporation.