STORY FROM: Drugs & Medical Devices

Express Preemption Adheres to FDA-Approved Hip Component, 3rd Cir. Rules

PHILADELPHIA - Negligence, strict liability, and breach of warranty claims filed against Smith & Nephew Inc. in connection with its R3 metal liner hip implant component are preempted by federal law, even though the component was used in a system other that for which it was indicated, a federal appeals court has affirmed.

In a March 1 opinion, the 3rd Circuit U.S. Court of Appeals concluded that when a single component of a Class III device is used on its own, rather than in the premarket-approved system, express preemption adheres to the individual premarket-approved component. In the instant case, the ...

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