Riegel v. Medtronic, Inc.

The Medical Device Amendments, of 1976 (MDA or Act), 90 Stat. 539, as construed by the Court, cut deeply into a domain historically occupied by state law. The MDA’s preemption clause, 21 U. S. C. § 360k(a), the Court holds, spares medical device manufacturers from personal injury claims alleging flaws in a design or label once the application for the design or label has gained premarket approval from the Food and Drug Administration (FDA); a state damages remedy, the Court instructs, persists only for claims “premised on a violation of FDA regulations.” Ante, at 330.1 I dissent from today’s…