United States Ex Rel. Heineman-Guta v. Guidant Corp.

718 F.3d 28, 85 Fed. R. Serv. 3d 1264, 2013 WL 2364172, 2013 U.S. App. LEXIS 11017
CourtCourt of Appeals for the First Circuit
DecidedMay 31, 2013
Docket12-1867
StatusPublished
Cited by23 cases

This text of 718 F.3d 28 (United States Ex Rel. Heineman-Guta v. Guidant Corp.) 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
United States Ex Rel. Heineman-Guta v. Guidant Corp., 718 F.3d 28, 85 Fed. R. Serv. 3d 1264, 2013 WL 2364172, 2013 U.S. App. LEXIS 11017 (1st Cir. 2013).

Opinion

THOMPSON, Circuit Judge.

Appellant Heidi Heineman-Guta (“Heineman-Guta”), on behalf of the United States, brought a qui tam action under the False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq., against Guidant Corporation (“Guidant”) and Boston Scientific Corporation (“BSC”) alleging they engaged in a kickback scheme to promote'the sale and use of their cardiac rhythm management devices. The district court dismissed Heineman-Guta’s complaint for lack of subject matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1) on the basis that an earlier-filed complaint barred consideration of Heineman-Guta’s complaint under the first-to-file rule of the FCA, id. § 3730(b)(5). Heineman-Guta challenges the dismissal, arguing on appeal, as she did below, that the earlier-filed complaint cannot adequately serve as a preclusive first-filed complaint to trigger the first-to-file bar because it does not meet the heightened pleading standard under Rule 9(b). 1

Heineman-Guta raises an issue of first impression in this circuit; that is, whether § 3730(b)(5) requires the first-filed complaint to meet the heightened pleading standards of Rule 9(b) to bar a later-filed *30 complaint. We-hold it does not and affirm the district court.

BACKGROUND

A. The FCA

To set the stage, we start with a brief overview of the FCA and the provisions that are relevant to this case. The FCA prohibits the knowing submission of false or fraudulent claims for payment, or causing the submission of such claims, to the federal government and prescribes fines and treble damages to penalize offenders. 31 U.S.C. § 3729(a). 2 The FCA’s qui tam provisions “supplement federal law enforcement resources by encouraging private citizens to uncover fraud on the government.” United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 727 (1st Cir. 2007). Such provisions permit private persons (known as relators) to bring certain fraud claims on behalf of the United States Government. 31 U.S.C. § 3730(b). 3 Qui tam actions are filed under seal and remain that way for at least 60 days. Id. § 3730(b)(2). This procedure gives the government an opportunity to assess the relator’s complaint and decide whether to intervene and assume primary responsibility for prosecuting the case. Id. § 3730(b)(2), (b)(4), (c)(1). A relator is entitled to recover a share of the proceeds from the action, subject to the requirements of the statute, regardless of whether the government decides to intervene. Id. § 3730(d).

The FCA also, however, includes certain jurisdictional bars, limiting a district court’s subject matter jurisdiction over qui tam actions. United States ex rel. Duxbury v. Ortho Biotech Prods., 579 F.3d 13, 16 (1st Cir.2009). As relevant to this case, the “first-to-file” rule bars a “person other than the Government” from “bring[ing] a related action based on the facts underlying the pending action.” 31 U.S.C. § 3730(b)(5). With this statutory scheme in mind, we turn to the two complaints against Guidant and BSC and detail the allegations made in each below. 4

B. The FCA Allegations Against BSC

1. The Bennett Complaint

On October 16, 2008, Elaine Bennett filed a qui tam action against BSC in the United States District Court for the District of Maryland. 5 In that action, Bennett, a former employee of BSC, claimed that between 2003 and early October 2008, BSC engaged in an unlawful kickback scheme within its Cardiac Rhythm Management (“CRM”) division to induce physi- *31 dans and hospitals to use BSC’s pacemakers, internal cardiac defibrillators, .and cardiac resynchronization therapy (“CRT”), thereby increasing the company’s market share of these devices. BSC has allegedly offered various types of remuneration to hospitals and physicians in exchange for their use of BSC’s devices in violation of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, and has caused physicians who received kickbacks to make false claims for reimbursement under Medicare in violation of the FCA.

BSC furthers its alleged kickback scheme in a number of ways: first, by “provid[ing] doctors and hospitals with kickbacks in the form of follow-up medical services in exchange for the providers’ use of BSC’s cardiac rhythm devices”; second, by “induc[ing] doctors and hospitals to bill for medical services and procedures they d[id] not perform”; third, by “requiring] BSC sales personnel to provide medical care in the absence of a licensed physician or staff member”; fourth, by “improperly conducting] Medicare billing for physicians and hospitals through non-licensed, non-medical staff’; fifth, by “providing] monetary ‘grants’ to foundations set up by physicians and physician groups in return for favored status by such physicians,” and; sixth, by “sponsoring] dinner meetings for implanting physicians to invite potential ‘referring physicians’ to, in order for the implanting physician to increase the number of patients he receives for implants from those referring physicians.” In most instances, “the benefitting implanting physician also receives an ‘honorarium’ for speaking about his or her expertise at the program.”

BSC provides physicians access to an internet-based monitoring system called “The Latitude Patient Management System” (“Latitude”), which allows patients to receive post-implant care from their residences without having to meet with a physician in-person. Latitude transmits information obtained from the implanted device through the internet to the physician’s office. The physician can then use the information to determine whether the device is working properly, and whether any adjustments are necessary. Part of BSC’s representatives’ follow-up care for a patient’s device includes office visits, “phone checks,” and driving to rural areas to conduct follow-up site visits. Because phone checks cost less than office visits, BSC representatives often conduct more phone consultations so that physicians can increase their billing to Medicare. BSC representatives advise physicians’ offices on how to bill Medicare for the maximum reimbursement for Latitude services.

In addition, BSC organizes networking events where surgeons can meet physicians who might provide referrals.

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Bluebook (online)
718 F.3d 28, 85 Fed. R. Serv. 3d 1264, 2013 WL 2364172, 2013 U.S. App. LEXIS 11017, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-heineman-guta-v-guidant-corp-ca1-2013.