United States Ex Rel. Ge v. Takeda Pharmaceutical Co.
737 F.3d 116
| 1st Cir. | 2013Background
- Dr. Ge filed two FCA qui tam actions against Takeda (Actos, Uloric, Kapidex/Dexilant, Prevacid) in June 2010; government did not intervene.
- Allegations center on Takeda's reporting of adverse events and alleged failures to disclose safety risks post-approval.
- District court dismissed for failure to plead fraud with particularity under Rule 9(b) and for failure to state a claim under Rule 12(b)(6).
- Ge moved to amend; district court denied amendments; she appealed the Rule 9(b) dismissal and denial of amendment.
- Court affirms dismissal and denial of leave to amend; reaches only Rule 9(b) and amendment issues, not Rule 12(b)(6).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does Ge plead Rule 9(b) fraud with particularity? | Ge alleges who, what, where, when of misconduct and its impact on claims. | Takeda contends Ge provides insufficient specifics to tie misconduct to any false claims. | Yes, primarily no; district court properly dismissed for lack of specifics. |
| Was the district court’s denial of two amendment requests abuse of discretion? | Ge should be allowed to amend; new data could cure pleading defects. | Dismissal should stand; amendment requests were improperly timed or waived. | No abuse; post-judgment amendments not allowed; pre-judgment amendment not properly requested. |
| Were Ge's new theories waived and thus not reviewable on appeal? | New theories support Rule 9(b) sufficiency. | Waived because not properly raised below and argued perfunctorily. | Waived; theories would not be considered and were deemed insufficient even if raised. |
| Did Ge properly advance theories of per se ineligibility, reasonable/necessary, or misbranding to support FCA liability? | The theories show all claims were false or not payable due to misconduct. | The theories were not properly presented or developed; waived. | Waived; no reversible error on these theories; Rule 9(b) deficiencies remain. |
Key Cases Cited
- United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720 (1st Cir. 2007) (public-domain damages and general fraud considerations; requires specific links to false claims)
- United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13 (1st Cir. 2009) (limits on parasitic relators; need for particulars for FCA claims)
- United States ex rel. Karvelas v. Melrose-Wakefield Hospital, 360 F.3d 220 (1st Cir. 2004) (details identifying false claims; some information required for Rule 9(b))
- United States ex rel. Clausen v. Lab. Corp. of Am., 290 F.3d 1301 (11th Cir. 2002) ( Rule 9(b) requirement does not relax for FCA; need specific allegations)
- United States ex rel. Gagne v. City of Worcester, 565 F.3d 40 (1st Cir. 2009) (applies Rule 9(b) to FCA claims; clarifies pleading standard)