On November 3, 2008, the U.S. Supreme Court heard oral arguments in Wyeth v. Levine. This case involves the question whether the Food and Drug Administration’s (“FDA”) regulation of prescription drug labeling pursuant to Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”) preempts state common law tort claims. The Supreme Court granted a petition for certiorari after the Supreme Court of Vermont rejected the preemption argument.
The Vermont Supreme Court decision involved claimant Diana Levine, who brought a common law negligence and products liability action against drug manufacturer Wyeth, for serious injuries sustained after her health care provider administered the anti-nausea medication Phenergan through the “IV push method.” Levine contended that the Phenergan label was inadequate in warning consumers about its possible risks when administered through the IV push method. Wyeth countered that the common law claims were preempted because: (1) the warning label was mandated by the FDA pursuant to its authority under the FDCA, making it impossible for Wyeth to simultaneously satisfy the requirements of both the FDA regulations and Vermont’s common law; and (2) federal objectives of the FDCA would be undermined if use of FDA-approved labels still left companies open to state liability.
In the arguments to the Supreme Court Justices, former Solicitor General Seth Waxman, representing Wyeth, argued that the FDA was aware of the risks involved in administering Phenergan through an IV push method and, after consideration of these risks, addressed such risks in the drug’s label that existed at the time Levine’s injuries occurred. He stated that Wyeth proposed a label with stronger language as to the risk associated with the drug, but the FDA rejected it. Waxman also argued that once a drug label is approved, the FDA requires drug manufacturers to use the precise FDA-approved label and they are prohibited from changing a label without prior FDA approval. The FDA's long-standing interpretation of the regulations allows such revisions when there is new information. Waxman argued that Wyeth did not acquire any new information about the risks of Phenergan not already known by the FDA, and therefore, could not change the FDA-approved label. Thus, the Vermont determination that Wyeth could have changed or supplemented the FDA mandated label directly conflicted with the requirements of federal law, and, accordingly, the state common law should be preempted.
Edwin S. Kneedler, the Deputy Solicitor General representing the United States, concurred with Wyeth’s arguments. In addition, Kneedler specifically asserted that state determinations as to the adequacy of drug labeling are preempted when the FDA has already considered information in approving a drug label and has made a determination that the drug is safe and effective under the conditions of recommended use suggested in the labeling.
Levine's attorney argued against preemption, stating that, under the FDA regulations, drug manufacturers are free to modify labels as necessary to comply with state products liability laws. He asserted that Wyeth could have complied with both federal and state law by simply supplementing the FDA-approved label. Levine's attorney also argued that the FDA regulations do not release drug manufacturers from liability after market approval, and, as such, they are responsible for monitoring post-market information and revising drug labels if there is evidence of serious risk associated with a marketed drug. He countered Wyeth’s assertion that there was evidence establishing the FDA weighed the comparative risks of the administration of Phenergan through the IV push versus the IV drip method, and that the FDA was aware of all the risks associated with Phenergan.
During the proceedings, the majority of questions from the Supreme Court Justices focused on narrow questions of whether (1) the FDA considered the different risks involved in the IV push versus the IV drip method; (2) warnings of the risks associated with the IV push method were already on the label; (3) Wyeth submitted all the information as to the risks of Phenergan, specifically in connection with the IV push method, to the FDA; and (4) Wyeth had the authority to change the label.