In United States v. Caronia, 703 F.3d 149, 168-69 (2d Cir. 2012), the government had not argued "that the promotion in question was false or misleading." Id. at 165 n.10.
Indeed, the court observed that "off-label promotion that is false or misleading is not entitled to First Amendment protection." Id.
The court also observed that "physicians and pharmaceutical manufacturers can be held accountable for off-label drug use through medical malpractice and negligence theories of liability." Id. at 168 n.11.