The Change in Knowledge Proposal: Repairing Preemption Doctrine in Medical Products Liability

Yite John Lu

Abstract

This Article proposes a new rule that would allow the FDA to achieve the best balance of medical product availability and safety without interference from tort law when the agency has adequately reviewed the safety science. After an analysis of the FDA’s competency to review, and manufacturers’ ability to hide, safety concerns, this Article argues that FDA review is adequate during the initial approval process, but the agency cannot adequately respond to newly acquired safety information that arises post-market. To take advantage of this finding, the change in knowledge proposal would require tort plaintiffs to show a change in the state of safety knowledge from FDA approval to the time of the injury.