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451 F.3d 104
Charles R. RIEGEL and Donna S. Riegel, Plaintiffs-Appellants,
v.
MEDTRONIC, INC., Defendant-Appellee.
Docket No. 04-0412-CV.
United States Court of Appeals, Second Circuit.
Argued: December 15, 2005.
Decided: May 16, 2006. 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.
Michael K. Brown, Reed Smith LLP, Los Angeles, CA (Richard Bakalor, Quirk and Bakalor, P.C., New York, NY, of counsel) for Defendant-Appellee.
Before: POOLER, KATZMANN, and B.D. PARKER, Circuit Judges.
Judge POOLER concurs in part and dissents in part in a separate opinion.
KATZMANN, Circuit Judge.
This case calls upon us to determine, inter alia, the scope of the preemption provision set forth in Section 360k(a) of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et. seq. Specifically, we must decide whether Section 360k(a) preempts common law tort claims regarding medical devices that have entered the market pursuant to the Food and Drug Administration's ("FDA") rigorous premarket approval ("PMA")...