Fourth Circuit dismisses False Claims Act case based on FDA cGMP Violations

Reed Smith Partner Larry Sher authored a post on the Drug and Device Law Blog about a recent decision in which the U.S. Court of Appeals for the Fourth Circuit affirmed the dismissal of a False Claims Act (“FCA”) case brought against Omnicare, United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, 2014 WL 661351 (4th Cir. Feb. 21, 2014). Rostholder is significant for the pharmaceutical industry and FCA jurisprudence because it shows that the court of appeals will carefully review statutes and regulations when relators attempt to use violations to make out an FCA claim, and will prevent efforts such as Rostholder’s to turn regulatory violations into FCA violations.

Click here to read the Reed Smith client alert about the same decision.