United States Second Circuit

Section 360(k)(a) of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts common law tort claims that allege liability regarding medical devices that have entered the market pursuant to the FDA's rigorous premarket approval process.

Appellate Information

• Decided 05/17/2006
• Published 05/17/2006

Judges

• Before:  POOLER, KATZMANN, and B.D. PARKER, Circuit Judges.

Court

• United States Second Circuit

Counsel

• For Appellant:
  
• Allison M. Zieve, Public Citizen Litigation Group, Washington, DC (Brian Wolfman, Public Citizen Litigation Group, Washington, DC;  Wayne P. Smith, Schenectady, NY, of counsel) for Plaintiffs-Appellants.


• For Appellees:
  
• Michael K. Brown, Reed Smith LLP, Los Angeles, CA (Richard Bakalor, Quirk and Bakalor, P.C., New York, NY, of counsel) for Defendant-Appellee.