Third Circuit Finds Pre-Emption in Prescription Drug Labeling Case

April 15, 2008

The pre-emption precedent based on FDA’s regulatory scheme continues to evolve. Applying a conflict pre-emption analysis, the U.S. Circuit Court of Appeals for the Third Circuit has held, in a 2-1 split decision, that plaintiffs’ failure-to-warn product liability claims are pre-empted by FDA’s rejection of the need for plaintiffs’ proposed warning. Colacicco v. Apotex Inc., et al., No. 06-3107 and McNellis v. Pfizer Inc., et al., No. 06-5148, (3rd Cir. April 8, 2008). The cases involved a class of anti-depressants known as selective serotonin reuptake inhibitors (“SSRIs”). In wrongful death actions arising from suicides, plaintiffs claimed that SSRI manufacturers failed to warn of the increased risk of emergent suicidality and worsening depression in adults taking SSRIs.

The ruling was explicitly narrowed to the regulatory history of SSRIs. The Third Circuit distinguished and did not decide the issue whether FDA’s mere approval of drug labeling pre empts state law failure-to-warn claims or whether, in the absence of FDA’s express rejection of a specific warning, FDA approval of drug labeling constitutes a minimum standard. The Third Circuit distinguished Levine v. Wyeth, 2006 WL 3041078 (Vt. 2006), cert. granted, 128 S. Ct. 1118 (2008), a case currently before the U.S. Supreme Court and scheduled for argument this fall. It is widely expected that the FDA pre-emption case law will reach a crescendo in Levine v. Wyeth.

The dissent, aggressively applying the presumption against pre-emption, would have declined to find pre-emption and left to Congress the choice to pre-empt state tort law.