In Riegel v. Medtronic, Inc ., 128 S. Ct. 999 (2008), decided in February 2008, the United States Supreme Court held that the Medical Device Amendments (“MDA”) to the Food Drug and Cosmetic Act (“FDCA”) expressly pre-empted common-law state claims involving Class III medical devices that had received FDA premarket approval. Relying on an express pre-emption clause contained in the MDA, 21 U.S.C. Section 360k(a), the Court held that state lawsuits were expressly pre-empted because they would impose requirements on Class III medical device manufacturers that were “different from, or in addition to,” the requirements already imposed by the FDA. But, relying on language in Medtronic v. Lohr, 518 U.S. 470, 495 (1996), the Court stopped just short of holding that all personal injury actions involving Class III medical devices were expressly pre-empted. As the Court explained:
Thus, Section 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.
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