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United States ex rel. Heineman-Guta v. Guidant Corp.
874 F. Supp. 2d 35
D. Mass.
2012
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Background

  • Relator filed a qui tam FCA action against Guidant Corp. and Boston Scientific Corp. (BSC) alleging kickbacks to promote cardiac rhythm management devices.
  • US declined to intervene in Oct. 2011; complaint unsealed and relator filed a first amended complaint (FAC) in Jan. 2012 focusing on kickbacks.
  • Relator, a Guidant/BSC account manager (2003–2007), witnessed and participated in a scheme offering trips, meals, honoraria, grants, and other benefits to referring physicians and residents.
  • Allegations claim violations of the Anti-Kickback Statute and false claims/records to Medicare/Medicaid under FCA (Counts I and II).
  • Defendants move to dismiss based on the first-to-file rule; Bennett and George earlier complaints are invoked as bar, with Bennett alleging a broad kickback scheme and charges in the CRM device area.
  • Court concludes Bennett provides an essential-facts bar to the FAC, while George does not, and the FAC is dismissed for lack of subject matter jurisdiction.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether the FAC is precluded by the first-to-file rule. Heineman-Guta argues Bennett bars later actions. Defendants contend Bennett is a proper prior action that displaces the FAC. Yes, Bennett bars the FAC.
Whether Bennett qualifies as a proper bar despite Rule 9(b) concerns. Heineman-Guta contends Bennett is not jurisdictionally proper due to Rule 9(b) particularity failures. Bennett sufficiently discloses essential facts; Rule 9(b) not required for first-to-file bar. Bennett can preclude the FAC despite Rule 9(b) issues.
Whether George precludes the FAC as a bar. George is not a kickback-scheme complaint and does not bar the FAC. George, though related, does not disclose the kickback scheme at issue. George does not preclude the FAC.
Whether the court should address alternative grounds for dismissal. Unnecessary since Bennett provides an absolute bar.

Key Cases Cited

  • United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13 (1st Cir. 2009) (essential-facts standard for first-to-file bar)
  • United States ex rel. Lujan v. Hughes Aircraft Co., 243 F.3d 1181 (9th Cir. 2001) (first-to-file bar concept and notice to government)
  • United States ex rel. Walburn v. Lockheed Martin Corp., 431 F.3d 966 (6th Cir. 2005) (first-to-file bar requires pending action and prevents related actions)
  • United States ex rel. Campbell v. Redding Med. Ctr., 421 F.3d 817 (9th Cir. 2005) (limits of first-to-file applicability; Rule 9(b) not necessary for preemption)
  • United States ex rel. Batiste v. SLM Corp., 659 F.3d 1204 (D.C.Cir. 2011) (D.C. Circuit rejects strict Rule 9(b) barrier to first-to-file bar; government-notice focus)
  • United States ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503 (6th Cir. 2009) (importance of essential-facts standard for first-to-file)
Read the full case

Case Details

Case Name: United States ex rel. Heineman-Guta v. Guidant Corp.
Court Name: District Court, D. Massachusetts
Date Published: Jul 5, 2012
Citation: 874 F. Supp. 2d 35
Docket Number: Civil Action No. 09-11927-RGS
Court Abbreviation: D. Mass.