568 F. App'x 783
11th Cir.2014Background
- Relator Michael Keeler filed a qui tam action under the False Claims Act on August 4, 2009 alleging Eisai promoted off-label drug uses and paid kickbacks.
- The Government declined to intervene; district court later dismissed the complaint with prejudice for failure to plead with Rule 9(b) particularity.
- Allegations focus on Ontak and Dacogen (and related drugs Aloxi, Fragmin) and include off-label promotion, physician/hospital payments, and reimbursement guarantees.
- Relator contends Eisai’s scheme caused submission of false claims to Medicare/Medicaid through promotions, grants, consulting payments, and an Oncology Reimbursement Assistance program.
- Court’s analysis centers on whether Relator linked the promotional conduct to actual submission of false claims with the required specificity under Rule 9(b).
- The court granted Eisai’s motion to dismiss with prejudice and later denied Relator’s motion to amend/reconsider; case closed for administrative purposes.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether off-label promotion allegations plead a false-claim theory | Keeler argues promotion caused false claims for reimbursement. | Eisai contends promotion alone cannot establish falsity without specifics linking to submitted claims. | No; claims fail for lack of particularity linking promotion to submitted claims. |
| Whether kickback allegations support FCA liability under express/implied certification | Kickbacks to physicians/hospitals undermine compliance with anti-kickback laws and certification to receive payment. | Allegations lack sufficient detail tying payments to actual claims or certifications. | No; pleading insufficient to show actual submissions or clear certifications. |
| Whether Best Price/price-reporting allegations meet Rule 9(b) pleading | Eisai falsified best price data to obtain higher rebates. | Plaintiff fails to identify specific pricing data or misreported statements tied to particular claims. | No; insufficient specifics to satisfy 9(b). |
| Whether a relaxed pleading standard is warranted for insider claims | As an insider, Relator should be allowed discovery-based relaxation of 9(b). | 9(b) should not be relaxed; claims require precise details regardless of insider status. | No; relaxation rejected; insufficient detailed allegations. |
Key Cases Cited
- Clausen v. Laboratory Corp. of Am., Inc., 290 F.3d 1301 (11th Cir. 2002) (centrally constrains Rule 9(b) pleading in FCA cases; requires specifics of actual claims)
- Solvay Pharmaceuticals, Inc. v. Hopper, 588 F.3d 1318 (11th Cir. 2009) (promotion schemes require linking to actual claims; 9(b) emphasized)
- Atkins v. McIntire, 470 F.3d 1350 (11th Cir. 2006) (requires showing that defendants submitted reimbursement claims; 9(b) linkage)
- Corsello v. Lincare, Inc., 428 F.3d 1008 (11th Cir. 2005) (highlights failure to plead before actual submission of claims)
- Wilkins v. United Health Gp., Inc., 659 F.3d 295 (3d Cir. 2011) (explains express/implied certification theory for anti-kickback violations)