Washington Law Review


Under the Medical Device Amendments of 1976 (MDA), Congress established a complex scheme for regulating medical devices. Congress also included an express preemption provision in the Amendments that prohibits states from imposing different or additional requirements on devices. Much controversy has focused on whether the preemption provision operates to preempt plaintiffs' state product liability claims against medical device manufacturers. Although in Medtronic, Inc. v. Lohr the U.S. Supreme Court recently attempted to resolve the controversy, its ruling left open the question of whether manufacturers of devices subject to the most rigorous form of Food and Drug Administration scrutiny, known as premarket approval review, should be immune from product liability lawsuits. This Comment argues that the overall purpose behind the MDA, the Lohr decision, and the federal interpretative regulations support preempting product liability claims involving devices subject to premarket approval review. This Comment concludes that product liability claims should be preempted to the extent that such claims involve aspects of devices addressed by premarket approval rules.

First Page


Included in

Torts Commons