The Second Circuit this week overturned the conviction of a pharmaceutical sales representative for conspiracy to engage in “off-label” marketing in violation of the Food, Drug & Cosmetic Act (the “Act”) in a decision that has implications for “whistleblower” cases brought against pharmaceutical employers by their employees.  In United States v. Caronia, No. 09-5006-cr, 2012 WL 5992141 (2d Cir. Dec. 2, 2012), a divided panel held that the Act could not be interpreted to criminalize truthful “off-label” marketing because such a reading would render the Act an unconstitutional violation of the drug manufacturer’s First Amendment rights.  “Off-label” marketing occurs when a drug or device is approved for one purpose but is marketed for other, non-approved purposes.


Continue Reading Second Circuit Off-Label Marketing Decision May Herald More Protection to Pharmaceutical Employers Facing Whistleblower Claims