Asher Block and Megan Grossman of Segal McCambridge Singer & Mahoney.
On March 1, the U.S. Court of Appeals for the Third Circuit addressed an issue of first impression: how courts should apply an express pre-emption provision to state law tort claims challenging the design and manufacture of a hybrid medical device, defined as a medical device comprised of differently classified components.
In Shuker v. Smith & Nephew, the Third Circuit affirmed a district court’s ruling that common law claims against a medical device manufacturer are expressly pre-empted by the Medical Device Amendments of 1976. At its essence, the Third Circuit’s holding finds that when dealing with a multicomponent medical device, pre-emption must be addressed on a component-by-component basis.
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