The Supreme Court recently granted a petition for certiorari to review a Second Circuit decision holding that the FDA approval process does not preempt certain state common law claims.
The Second Circuit decision, Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2006), involved claimants who brought Michigan tort claims for injuries allegedly sustained from their use of Rezulin, a now-withdrawn drug for the treatment of diabetes. The tort claims included an allegation of fraud-on-the-FDA by the drug manufacturer during the drug approval process. Such an allegation was necessary to trigger a built-in exemption in the Michigan statute immunizing drug manufacturers from product liability claims when a drug has been approved by the FDA. The Second Circuit decided that the tort claims were not preempted by the FDA. In so holding, the court distinguished the Supreme Court decision in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), which held that federal law preempted “fraud on the FDA” as a standalone claim.
This is the second grant of certiorari in recent months of Second Circuit decisions involving FDA preemption, an issue that has resulted in a split among the federal circuit courts. This past July, the Supreme Court agreed to review the decision in Riegel v. Medtronic Inc., 451 F.3d 104 (2006) to determine whether the FDA’s premarket approval process preempts state law claims.
Discussion of a recent California federal court decision finding against FDA preemption can be found here.