United States Ex Rel. Nargol v. Depuy Orthopaedics, Inc.

KAYATTA, Circuit Judge.

In this action brought by two private individuals under the False Claims Act (“FCA”), 31 U.S.C. § 3729, and various state analogues, we review de novo the dismissal of a complaint under Federal Rules of Civil Procedure 9(b) and 12(b)(6). Applying and extending our holding in United States ex rel. D’Agostino v. ev3, Inc., 845 F.3d 1 (1st Cir. 2016), we affirm the dismissal of the complaint to the extent it relies on the alleged falsity of statements made by the product manufacturer in securing approval from the U.S. Food and Drug Administration (“FDA”) to market a…