United States Ex Rel. Ibanez v. Bristol-Myers Squibb Co.
874 F.3d 905
| 6th Cir. | 2017Background
- Relators (former BMS sales reps Joseph Ibanez and Jennifer Edwards) sued BMS and Otsuka under the False Claims Act (FCA) and state analogues, alleging a nationwide scheme to promote the antipsychotic Abilify off‑label and to induce prescriptions via kickbacks, causing government reimbursement claims to be submitted.
- Relators relied on prior corporate‑integrity agreements and earlier enforcement actions for similar alleged misconduct, but claimed the improper promotion continued or restarted after those agreements.
- The government declined to intervene; relators filed a qui tam action. The district court dismissed the FCA claims under Rule 12(b)(6) for failure to meet Rule 9(b) particularity and denied leave to file a proposed third amended complaint as futile, leaving only retaliation claims.
- On appeal the Sixth Circuit reviewed (1) whether the second amended complaint satisfied Rule 9(b) as to § 3729(a)(1)(A) (presentment) and related provisions (§§ 3729(a)(1)(B),(C),(G)); and (2) whether the proposed third amended complaint was barred by the FCA public‑disclosure bar or would nonetheless survive Rule 12(b)(6).
- The court held relators failed to plead a representative false claim or adequate personal billing knowledge (the narrow Prather exception), and that the other FCA claims were too attenuated or inadequately alleged; it also found the proposed amendments would be futile and affirmed dismissal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether § 3729(a)(1)(A) presentment was pleaded with Rule 9(b) particularity (representative false claim) | Relators: scheme allegations + exhibits (state Medicaid reimbursements, example prescriptions, sales rep knowledge) suffice to identify representative claims or create strong inference that claims were submitted | Defendants: relators lacked any specific claim tied both to an allegedly tainted prescription and to a government reimbursement; relators lack billing knowledge required for relaxed standard | Court: dismissal affirmed — no adequately pleaded representative claim and Prather personal‑knowledge exception does not apply here |
| Whether Prather personal‑knowledge exception (relaxed 9(b)) applies | Relators: their inside sales rep knowledge + statistical evidence creates strong inference claims were submitted | Defendants: relators were not involved in billing or claim submission; personal knowledge limited to promotion | Court: exception limited to plaintiffs with direct billing documentation/knowledge (Prather); relators did not plead such billing knowledge; exception not met |
| Whether related claims under §§ 3729(a)(1)(B),(C),(G) survive | Relators: false statements, conspiracy, and reverse‑false‑claim theories tied to enforcement data and Corporate Integrity Agreements support claims | Defendants: connections between statements and government payment are too attenuated; conspiracy lacks agreement to defraud government; corporate‑integrity penalties are contingent (no present obligation) | Court: all three claims dismissed — (B) too attenuated, (C) insufficient conspiratorial agreement to get false claims paid, (G) obligations were contingent and not the type that create reverse false‑claim liability |
| Whether public‑disclosure bar precludes proposed third amended complaint | Relators: new post‑agreement misconduct allegations are not publicly disclosed and relators are original source of post‑agreement facts | Defendants: prior enforcement and CIAs publicly disclosed similar misconduct, barring claims | Court: partial concurrence — public‑disclosure bar does not automatically apply to post‑agreement allegations that the scheme continued or restarted; majority agrees public disclosure did not bar post‑agreement promotional allegations |
| Whether leave to amend should be denied as futile | Relators: proposed amendments cure earlier deficiencies and add representative examples and exhibits | Defendants: proposed third amended complaint still fails Rule 9(b) and public‑disclosure issues persist | Court: denial affirmed — proposed third amended complaint remains deficient under Rule 9(b) and related grounds; amendment would be futile |
Key Cases Cited
- United States ex rel. Prather v. Brookdale Senior Living Cmtys., Inc., 838 F.3d 750 (6th Cir. 2016) (personal‑knowledge exception to Rule 9(b) where relator had direct billing‑related knowledge)
- Chesbrough v. VPA, P.C., 655 F.3d 461 (6th Cir. 2011) (FCA fraud must meet Rule 9(b); mere scheme allegations insufficient without link to claims)
- United States ex rel. Bledsoe v. Cmty. Health Sys., Inc., 501 F.3d 493 (6th Cir. 2007) (representative false‑claim requirement under heightened pleading standards)
- United States ex rel. Marlar v. BWXT Y‑12, LLC, 525 F.3d 439 (6th Cir. 2008) (presentment element requires actual submission of a claim)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (complaints must state plausible claim; bare legal conclusions insufficient)
- Allison Engine Co. v. United States ex rel. Sanders, 553 U.S. 662 (2008) (connection between false statement and government payment must be non‑attenuated)
- Am. Textile Mfrs. Inst., Inc. v. The Ltd., Inc., 190 F.3d 729 (6th Cir. 1999) (reverse false claim requires a present obligation—contingent penalties typically do not qualify)
- United States ex rel. Polansky v. Pfizer, Inc., 822 F.3d 613 (2d Cir. 2016) (discussing practical difficulties of linking off‑label promotion to submission of knowingly false claims)
