Barclay Damon
Barclay Damon

Legal Alert

Supreme Court Limits Preemptive Effect of FDA Labeling

The Federal Food, Drug and Cosmetic Act, 21 U.S.C. §301 et seq. (“FDCA”) and its underlying regulations set forth a rigorous procedure that prescription drug manufacturers must follow to obtain approval of their products from the Food and Drug Administration (“FDA”). Included in those approvals is the labeling that the manufacturer is to place on the product. The United States Supreme Court, in Wyeth v. Levine, recently held that a manufacturer’s compliance with those regulations and the FDA’s subsequent approval of the labeling did not preempt a state-court products liability action for failure to warn.

In Wyeth, plaintiff, a professional musician, lost her forearm to gangrene when a drug manufactured by defendant Wyeth was not administered properly. Plaintiff argued that the warnings contained on the drug were insufficient. Wyeth argued that the failure to warn claim was preempted by the FDCA because (1) it was impossible for Wyeth to comply with the state court requirement for stricter warnings without violating federal law and (2) allowing state court actions for inadequate warnings would frustrate the federal regulatory scheme. The United States Supreme Court, in a 6-3 decision, rejected those defenses.

Initially, the Supreme Court found that under FDA regulations, a prescription drug manufacturer could provide stricter warnings for a product and then submit such a warning to the FDA for approval. “Impossibility,” therefore, was not a defense.

Secondly, and more importantly, the Supreme Court found that allowing state court tort actions based on inadequate warnings on prescription drugs did not frustrate the federal regulatory scheme for such products. In fact, the Court found that Congress, in enacting the FDCA, relied on such actions as an enforcement mechanism for the Act’s requirements.

Wyeth had relied on a preamble to a 2006 FDA regulation that declared the FDCA established both a “floor” and a “ceiling” for labeling so that FDA approval of labeling preempted conflicting or contrary state law. The preamble also stated that certain state-law actions, including failure-to-warn claims, threatened FDA’s statutorily prescribed role as an expert federal agency. The Supreme Court, however, refused to give any deference to the FDA finding of preemption.

In a discussion that is applicable to any assertion by a federal administrative agency that finds preemptive effect for its regulations, the Supreme Court held that the FDA, prior to the 2006 regulation, had repeatedly taken the position that such state court actions were an important enforcement tool under the FDCA and that FDA approval would not preempt state law tort claims. The FDA failed to provide any justification for the radical change in position. In addition, the Court found that the FDA’s assertion of preemption was contrary to the clear Congressional intent that the FDCA not preempt state court tort actions.

The Court distinguished Wyeth from Geier v. American Honda Motor Co., where the Court held that Department of Transportation (“DOT”) regulations regarding passive restraint systems preempted a state court design defect claim based on Honda’s failure to install air bags that the plaintiff claimed were required. The Court stated that in the Geier case, the DOT had developed a comprehensive passive restraint policy after extensive studies and formal rule-making.

That policy had rejected the all airbag system argued by the plaintiff in favor of a gradual phase-in of a mix of passive restraints. The plaintiff’s claim that Honda’s failure to install the airbags, therefore, presented an obstacle to achieving the variety and mix of restraints sought by the federal regulation.

The Supreme Court found no such problem with the Plaintiff’s claim in Wyeth and affirmed the Vermont Supreme Court’s ruling that the FDCA did not preempt the Plaintiff’s claim.