Hot Off the Presses – Third Circuit Resolves Conflicting Drug Labeling Preemption Decisions; Rules in Favor of Preemption

April 8, 2008

Earlier today, the U.S. Court of Appeals for the Third Circuit issued its much anticipated opinion in Colacicco v. Apotex, Inc.  (Several parties, including FDA, entered and argued the case as amici for the appellee.)  The case concerns whether actions taken by FDA pursuant to the FDC Act and the Agency’s implementing regulations preempt plaintiffs’ state law failure-to-warn claims against two drug manufacturers (Apotex and Pfizer) with respect to two selective serotonin reuptake inhibitors – paroxetine HCl (PAXIL) and sertraline HCl (ZOLOFT).  The plaintiffs alleged that the companies had violated state common law by selling their products with labeling that failed to warn consumers of the increased risk of suicidality and worsening depression in adults taking the drug products. 

The case was on appeal from two district court decisions.  First, in Colacicco v. Apotex, the U.S. District Court for the Eastern District of Pennsylvania dismissed a complaint in May 2006 on the basis of preemption.  Second, in McNellis ex rel. DeAngelis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006), the U.S. District Court for the District of New Jersey, after denying Pfizer’s motion for summary judgment that McNellis’s claim was preempted by federal law, denied in September 2006 (after to the district court’s decision in Colacicco) Pfizer’s motion to vacate the court’s denial of the summary judgment motion.  The New Jersey court framed the question for appeal as whether:

[FDA’s] requirements for the form and content of the labeling for the prescription antidepressant Zoloft preempted New Jersey’s failure-to-warn law, under the doctrine of conflict preemption, where the FDA’s regulations at 21 C.F.R. 201.57(e) [(2003)] and 314.70(c)(6)(iii) [(2007)] permit a manufacturer to unilaterally enhance its warning when the manufacturer has reasonable evidence of an association of a serious hazard with a drug. 

In affirming the Pennsylvania District Court’s decision dismissing Colacicco’s complaint, the Third Circuit held that “based on our own review of the FDCA, the FDA’s regulations, and the FDA’s actions taken pursuant to its statutory authority, we conclude that the failure-to-warn claims brought by Colacicco and McNellis conflict with, and are therefore preempted by, the FDA’s regulatory actions.”  This decision will likely loom large as the U.S. Supreme Court gears up to consider Wyeth v. Levine, which also concerns whether prescription drug labeling preempts state law product liability claims. 

By Kurt R. Karst    

Categories: Drug Development