Riegel v. Medtronic, 2006 U.S. App. LEXIS 12181 (2d Cir. 2006)
Tort claims by a man who suffered injuries after a balloon catheter burst while being inflated in one of his arteries were preempted by § 360k(a) of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., because the catheter had obtained premarket approval from the Food and Drug Administration. The Supreme Court of the United States would later affirm, holding that Preemption clause of the Medical Device Amendments, 21 U.S.C.S. § 360k(a), barred a patient's state common-law tort claims that challenged the safety and effectiveness of a manufacturer's heart catheter that received premarket approval from the FDA; the premarket approval imposed "requirements," and the state tort duties constituted "requirements."
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