The Mature Product Preemption Doctrine: The Unitary Standard and the Paradox of Consumer Protection

Abstract

The history of the U.S. Supreme Court's product preemption doctrine has been characterized by inconsistency and confusion. Product regulation and common-law product liability actions are primarily concerned with assuring the health and safety of the consuming public, and it is not surprising that the Court's product preemption decisions have focused substantially on medical devices and drugs. Recent government studies have shown, however, that the FDA is hampered in reaching its safety goals by insufficient resources and increasing demands. This article reassesses the Court's product preemption doctrine in the light of a triad of new decisions issued in 2008 and 2009. This article argues, first, that the new decisions demonstrate that the Court has embraced a unitary standard for product preemption, which merges previously discrete elements into a single, discretionary analytical process. The unitary standard lacks the desirable structure of a doctrine of this magnitude and leaves itself open to being applied in an arbitrary and unpredictable manner. This article then argues that although the Court continues to express respect for the traditional role of state tort actions in advancing consumer protection, a disconnect exists between those policy goals and the analytical process the Court uses, which places those goals in jeopardy. The unitary standard, paradoxically, invites arbitrary and unpredictable results and poses a threat to the public in the area of product safety.

Keywords: preemption, product liability, torts, tort law, constitutional law, supreme court, product safety, consumer protection

JEL Classification: K13