Historically, pharmaceutical companies have enjoyed some success in arguing that state law failure-to-warn claims are pre-empted by the Food Drug & Cosmetics Act (“FDCA”) and federal regulations.[1] However, on March 4, 2009, the United States Supreme Court announced limitations regarding the applicability of the preemption defense to a pharmaceutical company in Wyeth v. Levine.[2]

A Vermont trial court awarded Plaintiff, Diana Levine, $6.7 million in damages on her failure-to-warn claim against Wyeth after the administration of Wyeth’s drug Phenergan via the “IV push” method (as opposed to an intravenous drip method) caused her arm to develop gangrene and require amputation. Wyeth appealed, first to the Vermont Supreme Court, then to the United States Supreme Court, arguing that Levine’s failure-to-warn claims must be preempted because (1) Wyeth could comply with state law only by violating federal law, and (2) Levine’s claims “stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress”[3] since Congress intended the FDA to be the expert in pharmaceutical regulation and allowing a jury to second its decisions would frustrate the intent of Congress.

The underlying problem in the Levine case related to drug labeling. Pharmaceutical firms like Wyeth must obtain FDA approval of their labels, and they cannot deviate from the approved labels when they later sell their products. The FDA exercises its regulatory expertise by determining what label is best for patients and their medical providers. This involves delicate balancing of disclosing the right amount of usually needed information without overwhelming the label's reader. In essence, Levine's claim was that Wyeth should have provided additional information that was not included in the FDA-approved labels, and that a state jury could in effect overrule the FDA's determination that the Phenergan label was adequate.

The Supreme Court rejected Wyeth’s contention that it could comply with Vermont law only by making the label stronger, but federal law prohibited it from changing the label without prior FDA approval. The Court held that Wyeth could have changed the label without prior FDA approval pursuant to the “changes being effected” ("CBE") regulation,[4] so long as the change added or strengthened a warning or an instruction about administration and was based on newly-acquired information. Even though both Wyeth and the FDA knew of the risks of gangrene associated with using the IV push method of administering since the 1960’s, the Court determined that Wyeth had newly-acquired information because it could have conducted a new analysis of previously submitted data.

While the Court's majority conceded that the FDA could reject a company’s label change made pursuant to the CBE, "absent clear evidence that the FDA would not have approved a change to Phenergan's label,”[5] they refused to conclude that the FDA would have rejected the change that Plaintiff argued Wyeth should have made.

The Court also found no merit in Wyeth’s argument that Congress intended the FDA to serve as a panel of experts who can effectively balance the risks and benefits of prescription drugs and approve drug labels that reflect such a balance. The Court disregarded statements made in the Federal Register that FDA approval “pre-empts conflicting or contrary State law”[6] and derived the intent of Congress from other sources. The majority looked at the legislative history of the FDCA and noted that Congress enacted and amended that law in order to protect consumers from dangerous products. The Court also considered congressional failure to include an express preemption provision in the FDCA (like the express preemption provision it included for medical devices) as evidence that it did not intend preemption.

Despite the holding in Wyeth v. Levine, the preemption defense is not a hopeless effort. A pharmaceutical company may successfully assert such a defense to a failure-to-warn claim in some circumstances.

  • Preemption would be a valid defense if the pharmaceutical company can establish that the FDA rejected or would have rejected the proposed label change.
  • The CBE does not apply where a defendant has no "newly-acquired information." But based on the Wyeth Court’s interpretation of that term, such an argument would likely be successful only if no new data (including new adverse events, studies and/or analyses) indicating a greater risk of harm became available subsequent to the most recent label change.
  • CBE may not apply to generic drug manufacturers. As the Federal Register states, “CBE changes are not available for generic drugs approved under an abbreviated new drug application.”[7] Notably, within days of the Supreme Court’s decision, two courts held that failure-to-warn claims against generic drug manufacturers were not preempted, based at least in part on Wyeth v. Levine.[8]