Apotex and Pfizer Win Preemption Cases

The Third Circuit Court of Appeals has ruled that Apotex, GlaxoSmithKline (GSK) and Pfizer cannot be sued in two separate liability cases because the FDA’s labeling regulations preempt state failure-to-warn claims.

The court’s 2-1 decision concludes that the FDA actively monitored the risk of suicide from taking Apotex’s generic Paxil (paroxetine hydrochloride) and Pfizer’s Zoloft (sertraline HCl), antidepressant drugs classified as selective serotonin re-uptake inhibitors.

In a majority opinion, Judge Dolores K. Sloviter calls preemption “an area of the law that need delicately balance federal interests and those of the states,” which “is not a doctrine that lends itself to a black-letter-rule.” She also notes, “The decision must be based on the circumstances presented in the particular situation.”

The decision affects two consolidated cases. In Colacicco v. Apotex, a suit brought in Pennsylvania, Lois Colacicco was prescribed GSK's Paxil in October 2003, took a generic version made by Apotex and committed suicide less than a month later. Both Paxil’s and Apotex’s labeling included suicide precautions, but Colaccico’s husband alleged that the companies’ labeling failed to warn consumers of the increased risk of suicidality and worsening depression in adults. The U.S. District Court for the Eastern District of Pennsylvania had dismissed the complaint on the basis of FDA preemption.

In McNellis v. Pfizer, Theodore DeAngelis was prescribed Zoloft in January 2003 and committed suicide that month. His daughter, Beth Ann McNellis, filed suit against Pfizer in New Jersey state court, which denied Pfizer’s motion for summary judgment based on preemption.