• Recent Decision by the United States Court of Appeals for the Second Circuit: United States v. Caronia
  • December 12, 2012 | Author: Mark C. Levy
  • Law Firm: Eckert Seamans Cherin & Mellott, LLC - Philadelphia Office
  • In a much anticipated decision, the United States Court of Appeals for the Second Circuit, in United States v. Caronia, 09-5006-CR (2d Cir. December 3, 2012), reversed the conspiracy conviction of a pharmaceutical sales representative for his off-label promotion of an approved prescription drug. The Second Circuit held that the government’s use of the misbranding provisions of the Food, Drug and Cosmetic Act ( the “FDCA”) to prosecute speech by a product manufacturer’s representative who promotes an approved drug for an unapproved use violates the First Amendment. While doctors can prescribe approved products for unapproved uses without restriction, e.g., those indications not listed on the product’s approved label, the government has taken the position for more than a decade that pharmaceutical and device companies, as well as their representatives, cannot promote these same products for off-label use. Government enforcement of the FDCA to prohibit off-label promotion has resulted in high profile prosecutions and convictions of drug and device companies as well as billions of dollars in payments by drug and device companies to both state and federal governments, qui tam relators, and civil plaintiffs.