Parallel Claims: Exact Contours Will Continue to Be Litigated
In Riegel v. Medtronic, Inc., 552 U.S. 312, 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 pre-market 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:
Fraud on the FDA and Other Claims of Violating FDA Reporting Requirements
Manufacturing Defect Claims
Design Defect and Failure to Warn Claims
Express Warranty Claims
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