Navigating Between Scylla and Charybdis: Preemption of Medical Device 'Parallel Claims'

Abstract

The scope of federal preemption of state common law medical device claims has been vigorously debated since the Medical Device Amendments were enacted in 1976. Currently, a hot-button topic is the extent to which either express or implied preemption may bar state device claims that parallel duties imposed by the federal government’s Food, Drug, and Cosmetic Act. The author analyzes a selection of recent lower court cases in light of Congressional intent and Supreme Court precedent. This article provides some guiding principles to achieve greater consistency and predictability in parallel claim preemption decisions. The author then concludes that preemption doctrine and sound public policy mandate that some parallel claims should survive implied preemption and that medical device manufacturers should not be immune from all state-law claims simply because the device received marketing approval from the United States Food and Drug Administration.

Keywords: preemption, medical devices, health law, product liability, parallel claims

JEL Classification: K13