On Drugs: Preemption, Presumption, & Remedy

Abstract

This essay explores the role of litigation in drug safety regulation and the role of drug safety regulation in litigation, exemplified by the 2017 National Health Law Moot Court Problem. Using the example of failure-to-update claims against generic drug manufacturers, this essay argues that pharmaceutical preemption doctrine would benefit from a tailored application of the presumption against preemption. It proposes a presumption that Congress does not intend to displace historic state remedies for injury without clearly saying so, focusing on the role of remedy to account for the evolving overlap in federal and state police powers over health and to more precisely calibrate the federalism values inherent in the remedy-regulation relationship.

Keywords: preemption, presumption, remedy, litigation, drugs, pharmaceuticals, prescription drugs, generic drugs, attorney fees, Federal Rule 41, failure to update

JEL Classification: I18, K13, K23, K32, K41