The purpose of this paper is to explore the relationship between federal medical device regulation and state common law tort actions. Specifically, the issue to be addressed is whether the Medical Devices Act and regulations promulgated thereunder preempt state law damage actions brought by injured consumers against device manufacturers. An analysis of the preemptive provision of the Medical Devices Act and case law construing this provision is set forth below. The United States Supreme Court's recent preemption analysis in Cipollone v. Liggett Group, Inc. will be used as a guide in establishing a useful method for determining whether state tort claims arising out of consumer injuries resulting from defective medical devices are preempted by the Medical Devices Act.
Susan M. Mesner, Medical Device Technology: Does Federal Regulation of This New Frontier Preempt the Consumer's State Common Law Claims Arising from Injuries Related to Defective Medical Devices?, 7 J.L. & Health 253 (1992-1993)