PREEMPTION OF STATE PRODUCT LIABILITY CLAIMS INVOLVING MEDICAL DEVICES - PREMARKET APPROVAL AS A SHIELD AGAINST LIABILITY

Under the Medical Device Amendments of 1976 (MDA), Congress establishe d a complex scheme for regulating medical devices. Congress also inclu ded an express preemption provision in the Amendments that prohibits s tates from imposing different or additional requirements on devices. M uch controversy has focused on whether the preemption provision operat es to preempt plaintiffs' state product liability claims against medic al device manufacturers. Although in Medtronic, Inc. v. Lohr the U.S. Supreme Court recently attempted to resolve the controversy, its rulin g left open the question of whether manufacturers of devices subject t o the most rigorous form of Food and Drug Administration scrutiny, kno wn as premarket approval review, should be immune from product liabili ty lawsuits. This Comment argues that the overall purpose behind the M DA, the Lohr decision, and the federal interpretative regulations supp ort preempting product liability claims involving devices subject to p remarket approval review. This Comment concludes that product liabilit y claims should be preempted to the extent that such claims involve as pects of devices addressed by premarket approval rules.