US ex rel. Wilson v. Bristol-Myers Squibb
2014 U.S. App. LEXIS 8159
| 1st Cir. | 2014Background
- Relator Michael A. Wilson, a former BMS sales rep, sued BMS (and later Sanofi) under the False Claims Act for allegedly promoting Plavix, Pravachol, and Monopril for off‑label uses, causing false Medicaid claims. Wilson settled certain BMS claims in 2007; the government later declined to intervene in the remaining claims.
- Wilson filed a Second Amended Complaint (SAC) adding Sanofi and alleging nationwide off‑label promotion schemes using research sponsorship, altered "faxbacks," sales‑force training, and CME programs; he later sought to file a Proposed Third Amended Complaint (TAC) adding a second relator and more allegations.
- Two earlier qui tam suits existed: Richardson (D.D.C., May 2006) alleged nationwide off‑label promotion of Plavix and Pravachol using the same mechanisms (faxbacks, CME targeting, sales training); Piacentile (D.N.J., June 2005) alleged kickbacks to push Plavix.
- The district court dismissed the SAC’s FCA claims as to Plavix and Pravachol under the FCA first‑to‑file rule (31 U.S.C. § 3730(b)(5)), applying the First Circuit’s “essential facts” test and concluding Richardson put the government on sufficient notice; Monopril allegations were dismissed under Rule 9(b) (not appealed).
- The district court denied leave to file the TAC for undue delay and because many new allegations derived from the proposed new relator (violating FCA filing/service rules); a motion for reconsideration was also denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether SAC was barred by FCA first‑to‑file rule under the "essential facts" test | Wilson: SAC alleges different/off‑label uses (e.g., Plavix for PAD in diabetics) so it raises new, distinct claims not covered by Richardson | BMS/Sanofi: Richardson’s complaint disclosed the same drugs, nationwide off‑label schemes, and promotion mechanisms, providing the government essential facts | Court: Richardson provided essential facts; SAC barred under § 3730(b)(5) and dismissed for lack of jurisdiction |
| Whether Duxbury compels a different result | Wilson: Duxbury shows later‑added off‑label promotion details can survive if earlier suit lacked scheme allegations | Defs: Duxbury is distinguishable—there the earlier suit lacked any off‑label promotion scheme; here Richardson alleged the scheme and mechanisms | Held: Duxbury supports district court; differences in specific diseases do not overcome essential‑facts bar |
| Whether district court abused discretion in denying leave to file TAC (Rule 15) | Wilson: Proposed TAC would add material allegations and a second relator; delay justified by investigation/seal | Defs: TAC filed after undue delay; many new allegations attributable to new relator and TAC was not filed/sealed per FCA requirements | Held: Denial affirmed—undue delay and FCA defects provided adequate basis to deny amendment |
| Whether denial of reconsideration was improper | Wilson: District court committed manifest error of law in denying reconsideration to allow portions of TAC based on Wilson’s knowledge | Defs: Wilson failed to show newly discovered evidence or manifest error; prior rulings stand | Held: Denial of reconsideration affirmed; no abuse of discretion |
Key Cases Cited
- United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13 (1st Cir. 2009) (adopts and explains the "essential facts" test under § 3730(b)(5))
- United States ex rel. Heineman‑Guta v. Guidant Corp., 718 F.3d 28 (1st Cir. 2013) (first‑to‑file rule is jurisdictional; earlier complaint need only supply essential facts)
- United States ex rel. LaCorte v. SmithKline Beecham Clinical Labs., Inc., 149 F.3d 227 (3d Cir. 1998) (formulates essential‑facts/material‑elements approach and rejects an "identical facts" test)
- United States ex rel. Lujan v. Hughes Aircraft Co., 243 F.3d 1181 (9th Cir. 2001) (rejects identical‑facts test; explains policy justifications for first‑to‑file rule)