The Lawletter Vol 36 No 11
The U.S. Court of Appeals for the Fifth Circuit recently decided a case involving the issue of federal preemption of a state products liability statute requiring a plaintiff in a failure-to-warn case against a drug manufacturer to assert that the manufacturer withheld material information from the Food and Drug Administration ("FDA") or misrepresented such information to the agency. See Lofton v. McNeil Consumer & Specialty Pharms., No. 10-10956, 2012 WL 579772 (5th Cir. Feb. 22, 2012). The family of a man who died of a severe autoimmune allergic reaction after taking the defendant's over-the-counter drug, Motrin, brought an action against the manufacturer, alleging that the defendant had failed to warn consumers about the risk of such severe autoimmune reactions to the drug. The plaintiffs sued under Texas state law, alleging negligence and strict products liability.
The court of appeals noted that under Texas statutory law, there is a rebuttable presumption that a drug manufacturer is not liable for failing to warn about the risks of its product if the FDA has approved the warnings or information furnished in the sale of the drug. The Texas statute allows a plaintiff to rebut this presumption by establishing that the manufacturer withheld from, or misrepresented to, the FDA required information material and relevant to the performance of the product and that the manufacturer's act was causally related to the plaintiff's injury. The defendant manufacturer raised the Texas statutory presumption of nonliability as an affirmative defense, and the district court determined that the prerequisites to the presumption were satisfied because the manufacturer had complied with all FDA requirements governing the labels of the drug. The district court then held that the rebuttal portion of the statute was preempted by federal law. The court concluded that the Supreme Court's decision in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), extended preemption to fraud-on-the-FDA claims involving drugs, and noted that the FDA had rejected a 2005 Citizen's Petition requesting that the FDA strengthen labeling requirements for the defendant's drug. Because the plaintiffs were asking the court to reach a conclusion opposite to that reached by the FDA, the district court determined that the Texas rebuttal statute that potentially allowed such claims was preempted.The court of appeals affirmed. The court found that the Texas rebuttal statute was a fraud-on-the-FDA provision. According to the court, the rebuttal statute eliminates the presumption that a drug manufacturer is not liable only in cases where the defendant committed the same fraud that federal law empowers the FDA to punish and to deter. The court observed that state tort claims are impermissible if they exist solely by virtue of disclosure requirements contained in the Federal Food, Drug, and Cosmetic Act. The court concluded that in cases like the one under consideration, where the FDA has not found fraud, the threat of imposing state liability on a drug manufacturer for committing fraud on the FDA intrudes on the competency of the FDA and its relationship with regulated drug manufacturers. The court held, therefore, that the Texas rebuttal statute is preempted unless the FDA has itself found fraud on the part of a drug manufacturer.