Oral Argument in Wyeth v. Levine Marks Change in Drug Litigation Preemption Debate

February 16, 2009
On November 3, 2008, the Supreme Court heard oral argument in Wyeth v. Levine to decide the extent to which FDA approval of drug marketing and labeling should preempt personal injury lawsuits brought against prescription drug manufacturers. As of the drafting of this article, the Court has yet to hand down its ruling, and the outcome of the dispute between the two litigating parties is far from clear. What is clear, however, is that there has been a fundamental shift in the nature of the preemption debate. While prescription drug product liability plaintiff s historically have argued that FDA regulatory oversight imposes only “minimum standards” that state common law can exceed without any preemptive conflict, in the Levine argument plaintiff ’s counsel conceded that state tort law claims would be preempted by some types of FDA regulatory action. In so conceding, counsel eff ectively abandoned the “minimum standards” shibboleth, opening the door to case-by-case determinations of preemption focused on the nature of FDA’s drug-specific regulatory decisions....