Stevens v. AtriCure, Inc.

CourtDistrict Court, S.D. Ohio
DecidedSeptember 12, 2024
Docket1:22-cv-00284
StatusUnknown

This text of Stevens v. AtriCure, Inc. (Stevens v. AtriCure, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Stevens v. AtriCure, Inc., (S.D. Ohio 2024).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF OHIO WESTERN DIVISION AT CINCINNATI

JOEL STEVENS, et al., : : Plaintiffs, : Case No. 1:22-cv-284 : vs. : Judge Jeffery P. Hopkins : ATRICURE, INC., et al., : : Defendants. :

OPINION & ORDER

Relator Joel Stevens brings this qui tam action under the federal False Claims Act, 31 U.S.C. § 3729(a)(1)(A), (B), and (C) (“FCA”), predicated on alleged violations of the federal Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b), and supplemental claims under various state and local False Claims Act statutes and ordinances.1 This matter is now before the Court on Defendants’ motions to dismiss the Fourth Amended Complaint (Doc. 88) under Rules 12(b)(6) and 9(b) of the Federal Rules of Civil Procedure. Docs. 91, 92. Relator has responded to the motions (Docs. 99, 100) and Defendants have replied (Docs. 101, 102). For the reasons set out below, the Court GRANTS the motions, DISMISSES the federal claims WITH PREJUDICE and the supplemental claims WITHOUT PREJUDICE, and DENIES Relator’s request for leave to further amend the complaint.

1 The United States has filed a notice of declination of intervention, as well as that of several state and local jurisdictions whose laws Relator invokes. Doc. 29. No state or local jurisdiction has entered an appearance. I. BACKGROUND Relator is a former sales manager employed by Defendant AtriCure, Inc. (“Defendant AtriCure”). Doc. 88, ¶ 13, PageID 175. Defendant AtriCure is “a medical device company that specializes in creating equipment used to treat atrial fibrillation.” Id. at ¶ 14, PageID 175.

Defendant Adventist Health is a healthcare organization that operates approximately twenty hospitals in various states, including Defendant St. Helena Hospital, which operates in California (collectively, “the Hospital Defendants”) Id. at ¶ 15, PageID 176. Relator presents his claims in connection with Defendant AtriCure’s (“with the knowledge, involvement and participation of” the Hospital Defendants) alleged “promotion of its medical devices through the offer and payment of illegal kickbacks to surgeons, electrophysiologists [“EPs”], and health care facilities, including hospitals and clinics,” causing “false claims for payment to be submitted to and paid for by federal, state, city and county government healthcare programs” from “at least 2011 to the present.” Id. at ¶¶ 2–3, PageID 173. Specifically, Relator alleges the

following: First, AtriCure paid kickbacks in the form of cash payments that included lucrative consulting agreements through which it paid hourly and event-based fees to select groups of surgeons and EPs. These providers in turn promoted both the on-label and off-label use of AtriCure’s expensive products at conferences, trainings and patient outreach events. AtriCure additionally made cash payments to surgeons and EPs to induce them to perform off-label procedures that would expand the surgical patient population, and to appear on AtriCure’s behalf at promotional events for the ostensible purpose of providing or receiving educational information. Hospitals and their affiliated physician practices that agreed to host such events were awarded cash payments from AtriCure in the guise of “educational grants.” Second, AtriCure extended in-kind kickbacks to customers by paying third parties to perform consulting and professional credentialing and advertising services free of charge for surgeons and electrophysiologists who promoted AtriCure’s products for use in off-label procedures. AtriCure’s remuneration in the form of paid third-party consulting services included reimbursement services, placement of providers on the patient referral website https://www.stopafib.org/ and radio advertisements. Third, AtriCure gave kickbacks to hospitals in the form of free capital equipment and free disposable medical device products, conditioned on further purchasing and/or off-label use. AtriCure’s free capital equipment arrangements were routinely disguised as allegedly lawful loan agreements. Id., ¶¶ 5–7, PageID 174. These actions, Relator charges, “resulted in the submission of millions of dollars in false claims to the Government, to the detriment of taxpayers.” Id. ¶ 10, PageID 175. Relator seeks monetary damages, civil penalties, costs, expenses, and attorneys’ fees. Id. PageID 270–71. II. STANDARDS OF REVIEW All Defendants move to dismiss the Fourth Amended Complaint for failure to state a claim under Rule 12(b)(6) and, specifically, for failure to sufficiently plead fraud under Rule 9(b) of the Federal Rules of Civil Procedure.2 A party may move to dismiss a complaint for “failure to state a claim upon which relief can be granted” under Rule 12(b)(6) of the Federal Rules of Civil Procedure. Fed. R. Civ. P. 12(b)(6). To survive a motion to dismiss under this provision, a complaint must include “only enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). This, however, requires “more than labels and conclusions [or] a formulaic recitation of the elements of a cause of action,” and the “[f]actual allegations must be enough to raise a right to relief above the speculative level.” Id. at 555. “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal,

556 U.S. 662, 678 (2009). Indeed, under the plausibility standard set forth in Twombly and

2 The Hospital Defendants also invoke Rule 12(b)(1) in their motion to dismiss, but only to the extent that they ask that the Court decline to exercise jurisdiction over the supplemental claims if those claims are not dismissed with prejudice for failure to state a claim under Rule 12(b)(6). Iqbal, courts play an important gatekeeper role, ensuring that claims meet a plausibility threshold before defendants are subjected to the potential rigors (and costs) of the discovery process. “Discovery, after all, is not designed as a method by which a plaintiff discovers whether he has a claim, but rather a process for discovering evidence to substantiate plausibly-

stated claims.” Green v. Mason, 504 F. Supp. 3d 813, 827 (S.D. Ohio 2020). In deciding a motion to dismiss, the district court must “construe the complaint in the light most favorable to the plaintiff, accept its allegations as true, and draw all reasonable inferences in favor of the plaintiff.” Directv, Inc. v. Treesh, 487 F.3d 471, 476 (6th Cir. 2007). See also United States ex rel. Ibanez v. Bristol-Myers Squibb Co., 874 F.3d 905, 914 (6th Cir. 2017) (holding that, in a qui tam action, the court must construe the complaint in the light most favorable to the plaintiff, accept all factual allegations as true, and determine whether the complaint contains enough facts to state a plausible claim to relief on its face).

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Bluebook (online)
Stevens v. AtriCure, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/stevens-v-atricure-inc-ohsd-2024.