Cerveny v. Aventis, Inc.

Case Updates

The Tenth Circuit affirmed the district court’s decision granting summary judgment to Aventis on plaintiffs’ claim that the drug manufacturer had a duty to warn of the risks of taking Clomid prior to pregnancy. The court explained that the FDA’s rejection of a citizen petition containing arguments virtually identical to the plaintiffs’ constitutes “clear evidence” that the FDA would not have approved plaintiffs’ proposed warning.

However, the court reversed the dismissal of plaintiffs’ claim that Aventis should have warned of the risks of taking Clomid during pregnancy, and remanded for the district court to address that claim, as well as plaintiffs’ claims of fraud, negligent misrepresentation, and breach of implied warranty.

The U.S. Chamber filed an amicus brief in an appeal to the Tenth Circuit addressing whether the FDA’s rejection of a citizen petition seeking a drug label change can satisfy the “clear evidence” standard set forth in Wyeth v. Levine, 555 U.S. 555 (2009). That is, if the FDA has denied a petition seeking the label change that a state failure-to-warn suit would require, is such a state suit preempted under federal law? The Chamber’s brief, filed with the American Tort Reform Association and National Association of Manufacturers, urged the Court to affirm the district court’s judgment holding plaintiffs’ claims to be preempted by federal law.

The brief argued that courts assessing conflict preemption must ask whether federal law authorized the defendant to do what the plaintiff claims state law required. The brief further explained that regardless of whether there was a denied citizen petition, the manufacturer could not have effected a label change under federal law, and therefore the state law suit was properly found to be preempted.

Jeffrey S. Bucholtz, Sheldon Bradshaw, Andrew T. Bayman, and Heather M. Howard of King & Spalding LLP served as counsel for the amici in this case.