US ex rel. Wilson v. Bristol-Myers Squibb

750 F.3d 111, 2014 WL 1688934, 2014 U.S. App. LEXIS 8159
CourtCourt of Appeals for the First Circuit
DecidedApril 30, 2014
Docket13-1948
StatusPublished
Cited by34 cases

This text of 750 F.3d 111 (US ex rel. Wilson v. Bristol-Myers Squibb) is published on Counsel Stack Legal Research, covering Court of Appeals for the First Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
US ex rel. Wilson v. Bristol-Myers Squibb, 750 F.3d 111, 2014 WL 1688934, 2014 U.S. App. LEXIS 8159 (1st Cir. 2014).

Opinion

LYNCH, Chief Judge.

This appeal primarily involves the scope of the first-to-file rule of the federal False Claims Act (“FCA”), 31 U.S.C. § 3730(b)(5), and the application of the “essential facts” test to determine whether a later-filed complaint is barred by earlier-filed complaints under this provision. See United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13, 32-33 (1st Cir.2009).

Relator Michael A. Wilson, a former Bristol-Myers Squibb, Co. (“BMS”) sales representative, alleged that BMS and SanofíAventis U.S., LLC (“Sanofi”) unlawfully promoted Plavix for off-label uses, that BMS also unlawfully promoted Pravachol and Monopril, and that both companies “knowingly” caused the submission of false claims to the government in violation of the FCA. See United States ex rel. Hutcheson v. Blackstone Med., Inc., 647 F.3d 377, 380 (1st Cir.2011). After the government (and Wilson) benefitted from the settlement of certain claims Wilson, brought in his original complaint against BMS, the government declined to intervene in the litigation of the remaining claims. The district court dismissed the remaining FCA claims as expressed in a Second Amended Complaint because they ran afoul of the first-to-file rule.

Wilson now appeals from the dismissal, as well as from the denial of his motion to file a Third Amended Complaint and from denial of his followmp motion to reconsider. We affirm.

I.

A. Background and First Amended Complaint

Wilson’s employment at BMS was terminated in September 2004. In September 2006, he filed his original FCA complaint in the Central District of California under seal, to allow the United States time to review the complaint and to decide whether to intervene in the action, 31 U.S.C. § 3730(b)(2). He filed an amended complaint (“First Amended Complaint” or “FAC”) in October 2006, which alleged, inter alia, 1 that BMS violated the federal criminal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b)(2)(B), and engaged in off-label promotion of Monopril, Plavix, and Pravachol, and that these actions caused false claims to be submitted to the government in violation of the FCA. Physicians may prescribe Plavix, Pravachol, and Monopril for non-FDA-approved indications, but the Food, Drug and Cosmetic Act, 21 U.S.C. § 321 et seq., prohibits companies from marketing medications for such “off-label” uses, 2 and Medicaid generally does not reimburse patients for off-label prescriptions. See 42 U.S.C. § 1396r-8(k)(3), (k)(6); United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 723 (1st Cir.2007), overruled in part by Allison Engine Co. v. United States ex rel. Sanders, 553 U.S. *114 662, 128 S.Ct. 2123, 170 L.Ed.2d 1030 (2008).

In December 2006, while the government’s investigation was ongoing and the FAC was still under seal, the case was transferred to the District of Massachusetts.

On September 28, 2007, Wilson entered into a partial settlement agreement with BMS that concluded part of the case. Under the agreement, Wilson voluntarily dismissed with prejudice all federal FCA claims against BMS “except for claims relating to off-label promotion, retaliation, and wrongful termination to the extent they are alleged in Paragraphs 3-6, 9-60, 161-174, 176-178, 180, and 190-191 of the [FAC].” In the settlement, BMS denied any liability or wrongdoing related to Wilson’s allegations, but agreed to execute an agreement with the United States, under which BMS would pay the government $317,436,081, plus 4.5% per year interest from January 1, 2007 until the settlement amount was paid in full. Wilson received a portion of that sum.

On October 22, 2008, the government declined to intervene in what remained of the case.

B. Second Amended Complaint

On April 9, 2009, Wilson filed his Second Amended Complaint (“SAC”), also under seal. The SAC expanded upon Wilson’s earlier (not settled) allegations against BMS, and added Sanofi as a defendant for the first time. The SAC alleged that BMS engaged in schemes to promote Plavix, Pravachol, and Monopril for certain off-label uses, and that Sanofi participated in those schemes that related to the promotion of Plavix only. It is the dismissal of this complaint which is primarily at issue.

More specifically, the SAC alleged that (1) BMS promoted Pravachol, a drug the FDA had approved for lowering cholesterol, for off-label uses related to diabetes or insulin resistance syndrome; (2) BMS and Sanofi promoted Plavix, a drug the FDA had approved for lowering the risk of stroke and heart attack for patients with atherosclerosis or acute coronary syndrome, for off-label use by diabetic patients to prevent peripheral arterial disease (“PAD”); and (3) BMS engaged in the off-label promotion of Monopril, which the FDA approved to treat hypertension.

As to the mechanisms of the off-label promotions, Wilson alleged that BMS used the following schemes to promote Plavix and Pravachol: (1) sponsoring and promoting off-label research for these drugs; (2) training its sales force to promote off-label prescriptions, including using altered “fax back” requests; 3 and (3) promoting off-label uses in continuing medical education programs. He alleged that Sanofi used the same methods to promote off-label use of Plavix. Finally, Wilson alleged that BMS trained its representatives to promote off-label prescriptions of Monopril.

In August 2009, the court granted a motion to unseal the case. At this point, the parties agreed, with court approval, that because Wilson intended to amend his complaint again, BMS and Sanofi did not need to answer it until the court determined which complaint would govern.

*115 C.Denial of Leave to File Third Amended Complaint

On June 24, 2010, Wilson filed a Motion for Leave to Amend and File a Third Amended Complaint, and attached his Proposed Third Amended Complaint (“TAC”) to the motion. The TAC sought to add a second relator, Lucius O. Allen, Jr., also a former BMS employee, and to substantially expand the allegations in the SAC. The court (Gertner, J.) denied Wilson’s motion on June 16, 2011, reasoning in a thoughtful opinion that the TAC did not meet the requirements for amendment of Fed. R.Civ.P.

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750 F.3d 111, 2014 WL 1688934, 2014 U.S. App. LEXIS 8159, Counsel Stack Legal Research, https://law.counselstack.com/opinion/us-ex-rel-wilson-v-bristol-myers-squibb-ca1-2014.