United States ex rel. Ge v. Takeda Pharm. Co. Ltd., No. 13-1089 (1st Cir. 2013)Annotate this Case
Appellant filed two amended qui tam actions against her employer, a pharmaceutical company and its subsidiary (collectively, Appellees), under the federal False Claims Act (FCA), alleging that Appellees failed adequately to disclose the risks associated with some of their drugs and that this failure resulted in the submission of false claims by third-party patients and physicians for government payment. The district court dismissed both of Appellant's actions under Fed. R. Civ. P. 9(b) for failure to plead fraud with particularity and under Fed. R. Civ. P. 12(b)(6) for failure to state a claim. Appellant subsequently sought to amend the second amended complaint, asserting more theories of FCA liability, but the district court refused to allow further amendment. The First Circuit Court of Appeals affirmed the district court's rulings regarding the dismissal of Appellant's claim under Rule 9(b) and the denial of Appellant's proposed amendments, holding (1) Appellant's claims on all theories which were presented failed under Rule 9(b); and (2) the district court did not err in denying Appellant's motion to amend.