By Jennifer M. Thomas –
We wanted to briefly update our readers on a case we blogged about in February of this year, United States ex rel. Barry Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014). To recap, in Omnicare the Fourth Circuit affirmed a lower court’s dismissal of the False Claims Act (“FCA”) for failure to state a claim – rejecting the relator’s theory that Omnicare had violated the FCA when it produced drugs in violation of FDA regulations. On October 6th, the U.S. Supreme Court denied Rostholder’s petition for certiorari in the case (Case No. 13-1411).
Omnicare is a leading case among several in which qui tam plaintiffs have tried to shoehorn an alleged FDCA violation – such as an alleged cGMP violation – into a FCA case. Many hoped that the Supreme Court would hear the Omnicare case to bring certainty to the question of whether that theory is viable. Given the Supreme Court’s refusal to hear this case, we will need to await further lower court rulings to see if the Court will take the issue up in another case.