Fourth Circuit Rejects Inferential Pleading in False Claims Act Qui Tam Suit Regarding Off Label Marketing

Summary: Last month the Fourth Circuit issued a decision that alters the landscape of rulings regarding pleading requirements for an off label promotion claim under the Federal False Claims Act (FCA). In US ex rel. Nathan v. Takeda Pharmaceuticals North America, Inc., No. 11-2077, 2013 WL 136030 (4th Cir. Jan. 11, 2013), the Fourth Circuit affirmed the district court’s dismissal of a relator’s qui tam complaint alleging that the pharmaceutical manufacturer engaged in off label marketing of its heartburn medication Kapidex, resulting in the submission of false claims for reimbursement in violation of the FCA. In dismissing relator’s claim, the Court rejected the notion that relator could satisfy Rule 9(b)’s heightened standard by pleading only the existence of an off label promotion scheme without plausibly alleging that particular, identifiable false claims were actually presented to the government.