Post-decision diagnosis: medical device preemption alive and mostly well after Medtronic, Inc. v. Lohr.
In Medtronic, Inc. v. Lohr, the United States Supreme Court, in a five-to-four split, held that the Medical Device Amendments of 1976 did not preempt state tort claims against a pacemaker manufacturer. A careful reading of the factually specific holding of this case suggests that manufacturers of medical devices distributed pursuant to premarket approval requirements and investigational device exemption can still successfully raise preemption as a defense to state common law tort claims.
Sayler
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Shook, Hardy & Bacon LLP, Kansas City, MO, USA.
Thomas
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SM
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D007221:Industry / Q000331:legislation & jurisprudence*; D016365:Liability, Legal; D010138:Pacemaker, Artificial / Q000592:standards*; D013219:State Government; D014481:United States; D014486:United States Food and Drug Administration