Warner-Lambert Company LLC, et al. v. Kent, et al.

Case Updates

An equally-divided Supreme Court affirmed the decision below that federal law does not preempt a Michigan statute that affords a pharmaceutical manufacturer complete immunity against a product liability action if it can demonstrate that the allegedly defective product received the Food and Drug Administration’s approval, unless the approval was obtained by fraud. Because the Supreme Court decision was equally split, the Court’s opinion has no precedential value and confusion may persist among the lower courts.

NCLC urged the Supreme Court to clarify once and for all that the presumption against preemption simply does not apply to the analysis of whether state law conflicts with federal law. By statute, Michigan law affords a pharmaceutical manufacturer complete immunity against a product liability action if it can demonstrate that the allegedly defective product at issue received the Food and Drug Administration’s approval. This statutory immunity does not apply, however, if the plaintiff can demonstrate that the manufacturer made any misrepresentations in the course of obtaining approval. The court below applied the presumption against preemption, finding that the Michigan statute did not conflict with federal law. In addition to attacking the presumption against preemption’s place in conflict preemption analysis, NCLC also relied on the Court’s precedent in Buckman Co. v. Plaintiffs’ Legal Committee for the proposition that states are not permitted to police fraud on a federal agency