In Colacicco v. Apotex, et al, plaintiff alleged that his wife committed suicide as a result of taking Paroxetine, an anti-depressant. She had been prescribed Paxil, the brand name drug manufactured by GSK, but received the generic drug manufactured by Apotex. He alleged a failure to warn of an increased risk of suicide in patients taking the anti-depressant. Messrs. Fitzpatrick and Keppel filed a motion to dismiss in response to the complaint setting forth the preemption defense. Following extensive briefing, including briefing by the FDA, Judge Michael Baylson of the Eastern District of Pennsylvania dismissed the suit. The Third Circuit upheld the dismissal, becoming the first federal appellate court to uphold the preemption defense for a prescription drug manufacturer.

The court held that federal preemption applies when “the FDA has publicly rejected the need for a warning that the plaintiffs argue that state law requires.” The court rejected plaintiff’s argument that preemption did not apply because the defendant had not specifically sought the warning at issue and that the FDA had not formally rejected the warning plaintiff alleged was required. It also rejected the argument that the defendants could be liable for failing to add a supplemental warning despite the FDA’s scientific determination.

The decision was based upon the specific facts of the case. Therefore, the implications of the case in other factual settings remain to be seen. But the case specifically recognized the difficult dilemma which manufacturers face and stated that a legal system in which companies must submit numerous label changes and have them rejected by the FDA or face continuing lawsuits alleging that an endless variety of warnings should have been provided is most undesirable.