Medical Device Business Services, Inc., fka DePuy Orthopaedics, Inc., et al. v. United States, ex rel. Antoni Nargol and David Langton, et al.

The False Claims Act (“FCA”) imposes a civil penalty and treble damages on any person who presents, or causes a third party to present, a false or fraudulent claim to the United States government. Federal Rule of Civil Procedure 9(b) requires a party pleading an FCA case to “state with particularity the circumstances constituting fraud.” The Relators in this FCA qui tam action are not insiders with a government contractor and have never submitted a claim to the government; they are two British doctors who are serving as expert witnesses in ongoing product-liability actions against DePuy. Seeking to recover the FCA’s bounty, Relators have repurposed the product-liability allegations into an FCA complaint, which contains extensive detail about alleged defects in DePuy hip implants, but does not allege the details of any specific false claim submitted to the government. Instead, Relators simply allege that some hip implants were defective, that many hipimplant recipients are on Medicare and Medicaid, and that it is therefore statistically likely that at least some false claims were submitted to the government. The First Circuit held that those allegations satisfied Rule 9(b), even though Relators did not plead any particularized details about any specific false claim. The question presented, which has divided the courts of appeals, is: Whether a False Claims Act relator can satisfy Federal Rule of Civil Procedure 9(b)’s particularity requirement without alleging details about any specific false claim.