Appeals court upholds FDA's preemption rights

The U.S. District Court of Appeals for the Third Circuit in Philadelphia upheld FDA's power to preempt state product liability cases in two suits involving suicide in patients taking selective serotonin reuptake inhibitors (SSRIs) for depression. The court concluded that failure-to-warn claims brought by plaintiffs conflicted with, and are therefore preempted by, FDA's regulatory actions.

The appeals court affirmed a judgment of the U.S. District Court for the Eastern District of Pennsylvania dismissing Lois Colacicco's husband's claims that Apotex ( Weston, Ontario) and GlaxoSmithKline (LSE:GSK; NYSE:GSK) violated state common-law tort rules by failing to warn consumers of increased risk of emergent suicidality in adults taking paroxetine. GlaxoSmithKline markets paroxetine as Paxil, and Apotex markets a generic version, which Colacicco was taking at the time of her suicide. ...