Second Circuit Adopts False Advertising Safe Harbor For Statements Made On FDA-Approved Labeling

In a dispute between rival pharmaceutical manufacturers, the Second Circuit affirmed summary judgment for defendant Acorda Therapeutics, adopting the rule that "representations commensurate with information in an FDA label generally cannot form the basis for Lanham Act liability." The court noted that the rule reflects proper deference to FDA expertise and insulates companies from liability when they engage in commercial speech consistent with labeling requirements. It rejected plaintiffs' challenges to defendant's advertising statements that did not appear on the FDA-approved label, as the statements were consistent with the information on the label. After agreeing with the district court that a reasonable juror could understand one of Acorda's marketing brochures to communicate a literally false message, the appellate court nevertheless affirmed summary judgment, holding that plaintiff Apotex had failed to demonstrate materiality by adducing "evidence that this