96 F. Supp. 3d 504
E.D. Pa.2015Background
- Relator Gohil, a former Aventis employee, brings a qui tam FCA action on behalf of the United States alleging off-label marketing of Taxotere and kickbacks to induce prescriptions for reimbursable federal programs.
- Aventis allegedly promoted off-label Taxotere uses and paid illicit kickbacks to providers to expand sales, resulting in increased federal reimbursements for non-reimbursable uses.
- Taxotere received FDA approval for second-line NSCLC and breast cancer and later first-line NSCLC; there were no other approved indications at issue.
- Gohil's CEPA action against Aventis proceeded in New Jersey; a broad settlement and release disposed of post-employment claims, with related litigation occurring in this FCA matter.
- The Government elected not to intervene initially; the SAC was filed under seal, unsealed, and jurisdictional discovery followed, culminating in Aventis’s 12(b)(1) and 12(b)(6) challenges.
- The court granted in part Aventis’s motion, dismissing Counts III and IV without prejudice, denied the remainder, and allowed a third amended complaint.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Public disclosure bar jurisdiction | Gohil's claims are not based on publicly disclosed fraud. | SAC relies on public disclosures (SoF and WSJ article) triggering the bar. | Public disclosure bar not controlling; jurisdiction retained. |
| CEPA pre-filing release effect | CEPA settlement did not extinguish FCA rights; release invalid under public policy. | CEPA release bars the FCA action. | CEPA release not enforceable; action can proceed. |
| Pleading of false claims under Medicare/Medicaid (Counts III/IV) | SAC shows scheme to market off-label uses; claims plausibly rendered false. | Pleading is insufficiently specific under Rule 9(b) about unaccepted indications. | Counts III and IV dismissed without prejudice; leave to amend with specific medical indications. |
| Count II – Anti-Kickback Act and false certification | Wilkins permits express and implied false certification theories; AKS violations plausibly caused false claims. | No explicit false certification pleaded and some circuits disagree. | Count II survives; pleading sufficient under Wilkins/Grubbs/Foglia framework. |
| Count I – Conspiracy to submit false claims | SAC alleges unlawful agreement and acts to further it with kickbacks. | No adequate showing of a conspiratorial agreement. | Count I survives; sufficient circumstantial evidence alleged. |
Key Cases Cited
- U.S. ex rel. Paranich v. Sorgnard, 396 F.3d 326 (3d Cir. 2005) (articulates public disclosure bar framework)
- Springfield Terminal Ry. Co. v. Quinn, 14 F.3d 645 (D.C. Cir. 1994) (public disclosure analysis for FCA bar)
- Mistick PBT v. Housing Auth. of City of Pittsburgh, 186 F.3d 376 (3d Cir. 1999) (definition of 'based upon' public disclosures)
- U.S. ex rel. Zizic v. Q2Administrators, LLC, 728 F.3d 228 (3d Cir. 2013) (substantial similarity standard for public disclosures)
- U.S. ex rel. Foglia v. Renal Ventures Mgmt., LLC, 754 F.3d 153 (3d Cir. 2014) ( Rule 9(b) pleading standard for scheme to submit false claims)
- U.S. ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295 (3d Cir. 2011) (express and implied false certification theories; precondition to payment)
- Rodriguez v. Our Lady of Lourdes Med. Ctr., 552 F.3d 297 (3d Cir. 2008) (false certification theory analysis)
- Town of Newton v. Rumery, 480 U.S. 386 (1987) (public policy balancing in settlement enforcement)
- Grubbs v. Kanneganti, 565 F.3d 180 (5th Cir. 2009) (pleading a plausible scheme to submit false claims)
- Foglia v. Renal Ventures Mgmt., LLC (cited within), 2014 WL 1418293 (D.N.J. 2014) (context for Rule 9(b) and off-label evidence)