Legal Opinion
Walter Shuker v. Smith & Nephew PLC
Court of Appeals for the Third Circuit
Decided March 1, 2018No. 16-3785PublishedCited by 270 opinions
1Opinion of the Court
KRAUSE, Circuit Judge.
With the Medical Device Amendments of 1976, Congress added comprehensive medical device approval processes to the Federal Food, Drug, and Cosmetic Act, prescribing tiers of federal requirements for certain devices corresponding to the device's inherent risk level. In exchange for compliance with the strictest federal mandates, Congress afforded manufacturers express preemption from state laws imposing different or additional "safety or effectiveness" requirements for those devices. 21 U.S.C. § 360k(a)(2). This case presents an issue of first impression among the Courts…
2Cases cited56 opinions
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- Sandra Connelly v. Lane Construction CorpCourt of Appeals for the Third Circuit · 2016
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