United States of America v. Medtronic PLC

District Court, C.D. California·Decided February 23, 2022·No. 2:17-cv-01903·Unknown

Opinion

Case 2:17-cv-01903-ODW-SS Document 119 Filed 02/23/22 Page 1 of 13 Page ID #:2160

1 O 2 3 4 5 6 7 United States District Court 8 9 Central District of California

UNITED STATES OF AMERICA, et al., Case № 2:17-cv-01903-ODW (SSx) ex rel. DR. KUO CHAO, ORDER DENYING DEFENDANTS’ Plaintiffs, MOTION TO DISMISS [106] v.

MEDTRONIC PLC, et al., Defendants. This is a case brought under the federal False Claims Act, 31 U.S.C. §§ 3729– 3733. Defendants Medtronic PLC; Medtronic Vascular, Inc.; Covidien LP, and Covidien Sales LLC (collectively, “Medtronic”) move to dismiss Plaintiff-Relator Dr. Kuo Chao’s Third Amended Complaint. (Mot., ECF No. 106; Third Am. Compl. (“TAC”), ECF No. 102.) The Motion is fully briefed. (Opp’n, ECF No. 109; Reply, ECF No. 111.) After carefully considering the papers filed in connection with the Motion, the Court deemed the matter appropriate for decision without oral argument. Fed. R. Civ. P. 78; C.D. Cal. L.R. 7-15. For the following reasons, the Court DENIES Medtronic’s Motion. Case 2:17-cv-01903-ODW-SS Document 119 Filed 02/23/22 Page 2 of 13 Page ID #:2161

2 For purposes of this Rule 12(b)(6) motion, the Court accepts Dr. Chao’s 3 well-pleaded allegations as true. Lee v. City of Los Angeles, 250 F.3d 668, 688 (9th Cir. 4 2001). 5 Medtronic is the manufacturer of a medical device called the Pipeline, a flexible 6 cylinder-shaped medical device that is surgically inserted at the site of a brain aneurysm 7 to help treat the aneurysm and its associated symptoms. (TAC ¶¶ 29–40.) Doctors 8 order Pipeline devices for their patients; Medtronic provides the devices to the hospitals 9 where the doctors work; and the hospitals seek reimbursement for the Pipeline device from Medicare, Medicaid, and other government health care programs. (See TAC ¶¶ 45–46.) Dr. Chao alleges that these reimbursements are tainted with fraud because they are the result of a multifaceted kickback scheme in which Medtronic compensates doctors to induce them to order a greater number of Pipeline devices for their patients. (See TAC ¶ 9.) The kickbacks Dr. Chao alleges take four forms. First, Dr. Chao alleges that Medtronic maintains a proctoring program through which it regularly overpays doctors for professional services. Through the proctoring program, Medtronic hires doctors with experience inserting Pipelines as proctors to teach other doctors how to perform the Pipeline procedure, in part by being present for and supervising the procedure when performed by the trainee doctor. These proctors are themselves doctors with their own practices, and the gravamen of Dr. Chao’s accusation is that Medtronic systematically and habitually overpays its proctors for their proctoring services, which functions as a disguised kickback meant to incentivize the doctors to order more Pipelines for their own practices. (TAC ¶¶ 107–130.) As an example, Dr. Chao sets forth allegations regarding one Dr. Woodward, who took excessive payments for both himself and his companies in exchange not only for his proctoring and medical data analysis services but also as a disguised kickback for continuing to use a high volume of Pipeline devices in his own practice. (TAC ¶¶ 248–257.)

2 Case 2:17-cv-01903-ODW-SS Document 119 Filed 02/23/22 Page 3 of 13 Page ID #:2162

1 Second, Dr. Chao alleges that Medtronic acquired, at an inflated rate, companies 2 in which doctors with a high volume of Pipeline usage held ownership interests. The 3 result of these acquisitions was that the doctors received a substantial windfall which 4 significantly exceeded the fair market value of their ownership interests. These 5 windfalls, Dr. Chao argues, constitute a kickback that improperly induced these doctors 6 to perform more Pipeline procedures. (TAC ¶¶ 204–240.) 7 Third, Dr. Chao alleges that Medtronic maintained two data collection registries, 8 IntrePED and ASPIRe, that it also used to disguise kickback payments to its Pipeline- 9 using doctors. Medtronic asked doctors who performed Pipeline procedures to upload a small amount of patient- and procedure-related data to these registries in exchange for a substantial payment. This data was very easy for doctors to gather, and Medtronic paid the doctors for this data in excess of both the fair market value of the data and the value of the doctors’ collection efforts. This excess, Dr. Chao alleges, constitutes a kickback. (TAC ¶¶ 170–203.) Fourth, Dr. Chao alleges that Medtronic distributed illegal kickbacks to doctors and hospitals disguised as fellowships, grants, and research funds. Medtronic distributed these funds based in part on the doctors’ or hospitals’ volume of Pipeline usage. Thus, Dr. Chao alleges, these fellowships, grants, and research funds functioned as improper direct compensation for using more Pipeline devices—the very definition of a kickback. (TAC ¶¶ 241–262.) Dr. Chao is a medical doctor with experience in the treatment of aneurysms and is currently affiliated with the Kaiser Permanente Los Angeles Medical Center. (TAC ¶ 17.) He became aware of Medtronic’s business practices through his personal experience as a doctor interacting with Medtronic personnel and proctors. (TAC ¶ 18.) On March 9, 2017, believing Medtronic’s business activity to constitute a violation of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, and the associated government health care program reimbursements to therefore constitute a fraud on the government, Dr.

3 Case 2:17-cv-01903-ODW-SS Document 119 Filed 02/23/22 Page 4 of 13 Page ID #:2163

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