• Federal Court Finds that FDA Drug Approval is not Complete Defense to False Claims Act Allegation Involving On-Label Promotion
  • March 7, 2013
  • Law Firm: Cadwalader Wickersham Taft LLP - New York Office
  • On January 30, 2013, in United States ex rel. v. Bristol Myers Squibb Company & Sanofi-Aventis U.S., LLC et al., Civ. No. 11-00246 (S.D. Ill.) (“BMS & Sanofi-Aventis”), the Court denied a motion to dismiss the relator’s second amended False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq. complaint alleging the defendants made false efficacy claims regarding Plavix, even though the United States Food and Drug Administration (“FDA”) approved Plavix for the promoted uses. This decision is significant for several reasons, including because (a) it will likely embolden the continued emergence of new FCA relator and government enforcement theories concerning the marketing of drugs; (b) it does not expressly distinguish another recent court decision suggesting that FDA approval for a promoted use will preclude FCA liability for promotional activities consistent with that approved use; and (c) it will require life-science companies to remain vigilant as they monitor the promotion of their products, even for approved uses.