While advertising off-label claims for medical devices and pharmaceuticals may be like sailing into stormy waters, companies might assume that advertising their products based on FDA-vetted labeling is, if not a safe harbor, at least a reasonably sheltered cove. The recent Second Circuit decision in Church & Dwight Co. Inc., v. SPD Swiss Precision Diagnostics, GMBH, Dkt. No. 15-241, 12016 WL 4708179 (2d Cir. Sept. 9, 2016), affirming a finding of Lanham Act false advertising liability based on an over-the-counter home-pregnancy test’s “Weeks Estimator” advertising, challenges this seafaring assumption:
The fact that the FDA has satisfied itself that a product’s labeling is sufficiently accurate to secure FDA approval gives no assurance that the intervention of a competitor would not reveal problematic misleading messaging that is harmful to the competitor’s interests . . . .
The Second Circuit’s ruling that FDA approval “gives no assurance” that advertising claims based on approved labeling are not “misleading” appears contrary to another unanimous Second Circuit decision issued less than four months earlier. Apotex, Inc. v. Acorda Therapeutics, Inc. Dkt. No. 14-4353, ___F.3d___, 2016 WL 2848911 (2d Cir. May 16, 2016), held “that representations commensurate with information in an FDA labelgenerally cannot form the basis for Lanham Act liability.” (emphasis added). Given these contradictory directions from the Second Circuit, advertisers of products whose promotional and labeling claims are subject to FDA vetting and oversight – including the manufacturers and distributors of foods, medical foods, drugs, cosmetics, medical devices, and biologics – must navigate cautiously even when basing their advertising on FDA approved labeling.