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
FDA approval
Intra-Circuit split should give advertisers pause
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…