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Key Pre-emption Ruling in Third Circuit
On April 8, 2008, the Third U.S. Circuit Court of Appeals issued a significant decision concerning the authority of federal regulatory agencies to pre-empt state tort claims, Colacicco v. Apotex Inc., No. 6-5148. The decision, authored by the former chief judge of the Third Circuit, holds that when the Food and Drug Administration (the 'FDA') publicly concludes that a specific warning is unnecessary for a prescription pharmaceutical, state tort law cannot supply a cause of action for failure to include the rejected warning in the product's labeling.
The plaintiffs in the two cases consolidated for appeal were the husband and daughter, respectively, of two adults who committed suicide after taking anti-depressant drugs known as selective serotonin reuptake inhibitors ('SSRIs'). The drugs in question were Zoloft', Paxil', and the generic drug containing the active ingredient in Paxil, paroxetine hydrochloride. The plaintiffs argued that, under state law, the manufacturers should have warned physicians of the association between these drugs and an increased risk of suicidal thoughts and behavior ('suicidality'). The FDA, however, had repeatedly rejected the scientific basis for the warning suggested by the plaintiffs. The defendants argued that the FDA's actions pre-empted the plaintiffs' state-law failure-to-warn claims.
The FDA filed an amicus brief in which it argued that the basis for federal pre-emption was not the FDA's labeling guidelines themselves but rather the FDA's broad authority ' and responsibility ' to accept or reject a warning based on its evaluation of the safety and efficacy of the drug and the balancing of its risks and benefits. The court ruled that the FDA's rejection of the warning the plaintiffs proffered pre-empted the plaintiffs' state-law tort actions.
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