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Key Pre-emption Ruling in Third Circuit

By Alan Klein and Thomas A. Lincoln
May 28, 2008

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.

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