United States Ex Rel. Nathan v. Takeda Pharmaceuticals North America, Inc.
707 F.3d 451
| 4th Cir. | 2013Background
- Relator filed a qui tam FCA action alleging Takeda caused false claims for off-label Kapidex prescriptions.
- The district court dismissed the amended complaint under Rule 12(b)(6) for failure to plead presentment and causation; Relator amended.
- The court applied Rule 9(b) with Iqbal plausibility to FCA fraud claims, requiring particularity about presentment of false claims.
- Relator alleged four schemes: promoting Kapidex to rheumatologists, distributing 60 mg samples, PCPs’ prescriptions, and affidavits from physicians—all linked to off-label use.
- The court held the amended complaint failed to plausibly allege presentment of any false claim to the government and denied Relator leave to file a fourth amendment; the causal element was not reached on appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Pleading presentment under FCA and Rule 9(b) | Relator argues a detailed fraudulent scheme suffices to show presentment. | Takeda argues specific, identifiable presentment of false claims to the government is required. | Dismissal affirmed; presentment must be plausibly pled. |
| Leave to amend fourth time | Relator seeks another amendment to cure deficiencies. | Repeated amendments would be prejudicial and futile; finality concerns. | District court did not abuse discretion in denying fourth amendment. |
Key Cases Cited
- United States ex rel. Wilson v. Kellogg Brown & Root, Inc., 525 F.3d 370 (4th Cir. 2008) (Rule 9(b) particularity required for FCA claims; identify time, place, content of misrepresentation and person)
- Harrison v. Westinghouse Savannah River Co., 176 F.3d 776 (4th Cir. 1999) (False Claims Act liability hinges on actual presentment of a true government claim)
- Ashcroft v. Iqbal, 556 U.S. 662 (Supreme Court 2009) (Plausibility standard for pleading; complaints must include more than mere consistency with liability)
- Clausen v. Lab. Corp. of Am., 290 F.3d 1301 (11th Cir. 2002) (Rule 9(b) required allegations of presentment; cannot rely on mere conjecture)
- Grubbs v. KanNEGanti, 565 F.3d 180 (5th Cir. 2009) (Specific dates of services support inference of claims presented; context supports presentment)