Products Liability Update - May 2012 - Part 1

SUPREME COURT DECISION OPENS DOOR FOR POSSIBLE IMPLIED CONFLICT PREEMPTION OF OVER-THE-COUNTER DRUGS

By David B. Sudzus, B. Todd Vinson and Russell J. Chibe

The United States Supreme Court's most recent pronouncement on federal preemption, decided in the context of generic prescription drugs, appears destined to be at the forefront in future battles over unsettled questions regarding preemption in the context of nonprescription, over-the-counter (OTC) drugs. In PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law preempted state law failure to warn claims asserted against generic drug manufacturers. The Court's preemption holdings, couched in terms of "impossibility" borne out of federal regulatory requirements of "sameness," could arguably have similar applicability in the context of OTC drugs regulated under the FDA's "monograph" regime.