DRI The Voice of the Defense Bar

In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (“Lohr”), the Supreme Court rejected preemption arguments against product liability claims involving medical devices cleared by FDA for marketing as “substantially equivalent” under §510(k) of the Medical Device Amendments of 1976 (“MDA”) (21 U.S.C.A. §360(k)).

Lohr held that that §510(k) did not impose device-specific federal requirements warranting express preemption under 21 U.S.C. §360k(a).  Id. at 503.  However, the relevant statutory, regulatory, and legal framework of §510(k) has evolved considerably since FDA considered the device in Lohr in 1982.  So has the law applicable to express preemption.  This evolution warrants a ground-up reconsideration of 510(k) express preemption under MDA §360k(a).

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