Preemption of State Law Claims Involving Medical Devices: Why Increasing Liability for Manufacturers is a Perilous but Pivotal Proposition Right

Neil M. Issar · 17 Vand. J. Ent. & Tech. 4

Abstract

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA’s express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit Court of Appeals’ cases that have ruled against federal preemption to buttress new or existing product liability claims. Device manufacturers are also changing their approach to tackle the large number of impending lawsuits. This Note proposes resolving the circuit split by condensing the scope of federal preemption and further increasing liability for manufacturers to an unprecedented scale such that the tort regime substantially supplements federal agency enforcement.