On December 2, 2016, the United States Court of Appeals for the Second Circuit denied rehearing by the Panel and rehearing en banc. On December 5, 2016, the Court withdrew its previous opinion, which was to have been published with the reporter cite 836 F.3d 153, and directed that it will be republished as an … Continue reading
In our September 28, 2016 blog post, and subsequent Law360 Article, we reported that an internal Second-Circuit split had arisen regarding the deference owed to allegedly false and misleading pharmaceutical/medical device advertising where the FDA had considered and approved similar claims for labeling. The earlier decision involved in the split, Apotex, Inc. v. Acorda Therapeutics, Inc. 823 F.3d 51 (2d … Continue reading
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, … Continue reading