Health Choice Alliance v. Eli Lilly

4 F.4th 255
CourtCourt of Appeals for the Fifth Circuit
DecidedJuly 7, 2021
Docket19-40906
StatusPublished
Cited by12 cases

This text of 4 F.4th 255 (Health Choice Alliance v. Eli Lilly) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fifth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Health Choice Alliance v. Eli Lilly, 4 F.4th 255 (5th Cir. 2021).

Opinion

Case: 19-40906 Document: 00515928635 Page: 1 Date Filed: 07/07/2021

United States Court of Appeals for the Fifth Circuit United States Court of Appeals Fifth Circuit

FILED July 7, 2021 No. 19-40906 Lyle W. Cayce Clerk

United States of America, Ex Rel., Health Choice Alliance, L.L.C., on behalf of United States of America and 31 States (AR; CA; CO; CT; DE; DC; FL; GA; HI; IL; IN; IA; LA; MD; MA; MI; MN; MT; NV; NH; NJ; NM; NY; NC; OK; RI; TN; TX; VT; VA; WA),

Plaintiffs—Appellants,

versus

Eli Lilly and Company, Incorporated; VMS BioMarketing; Covance, Incorporated; United BioSource Corporation; HealthSTAR Clinical Education Solutions, L.L.C.; Covance Market Access Services, Incorporated,

Defendants—Appellees,

United States of America,

Appellee,

______________________________

United States of America, Ex Rel., Health Choice Group, L.L.C., on behalf of United States of America and 31 States (AR; CA; CO; CT; DE; DC; FL; GA; HI; IL; IN; IA; LA; MD; MA; MI; MN; MT; NV; NH; NJ; NM; NY; NC; OK; RI; TN; TX; VT; VA; WA), Case: 19-40906 Document: 00515928635 Page: 2 Date Filed: 07/07/2021

No. 19-40906

Plaintiff—Appellant,

Bayer Corporation; Amgen, Incorporated; Onyx Pharmaceuticals, Incorporated; AmerisourceBergen Corporation; Lash Group,

Appellee.

Appeals from the United States District Court for the Eastern District of Texas USDC No. 5:17-CV-123 USDC No. 5:17-CV-126

Before Higginbotham, Elrod, and Haynes, Circuit Judges. Jennifer Walker Elrod, Circuit Judge: * The appellants Health Choice Alliance and Health Choice Group brought qui tam actions under the False Claims Act on behalf of the United States alleging violations of the Anti-Kickback Statute by pharmaceutical companies. The United States moved to dismiss the actions, and the district court granted the motion. Because the actions were properly dismissed, we AFFIRM.

I. Health Choice Alliance and Health Choice Group (collectively Health Choice) are both entities created by the National Health Care Analysis Group

* Judge Haynes concurs in the judgment only.

2 Case: 19-40906 Document: 00515928635 Page: 3 Date Filed: 07/07/2021

for the purpose of filing qui tam actions alleging instances of fraud in medicine and pharmaceuticals. Health Choice and affiliated entities brought eleven qui tam actions under the False Claims Act against a total of thirty-eight defendants alleging similar violations of the Anti-Kickback Statute. 31 U.S.C. § 3730(b); 42 U.S.C. § 1320a-7b(b). This appeal concerns two of those qui tam cases, against Eli Lilly and Company and Bayer Corporation. 1 The complaints in both the Eli Lilly and Bayer cases allege that the defendants illegally provided patient-education services to providers before a prescription had been written in violation of the Anti-Kickback Statute and certain state laws. Health Choice filed two similar complaints against Eli Lilly and (initially) four other defendants and against Bayer and four other defendants

1 The nine cases which are not at issue in this appeal are: United States ex rel. CIMZNHCA v. UCB, Inc., 970 F.3d 835, 852, 854 (7th Cir. 2020) (remanding and instructing the district court to dismiss the case on the government’s motion and stating that “[w]herever the limits of the government’s power lie, this case is not close to them”), remanded to No. 3:17-CV-765 (S.D. Ill. Sept. 28, 2020), cert. denied, No. 20-1138, 2021 WL 2637991 (June 28, 2021); United States ex rel. SMSPF, LLC v. EMD Serono, Inc., 370 F. Supp. 3d. 483, 491 (E.D. Pa. 2019) (granting government’s motion to dismiss); United States ex rel. NHCA-TEV, LLC v. Teva Pharm. Prods. Ltd., No. 17-CV-2040, 2019 WL 6327207, at *6 (E.D. Pa. Nov. 26, 2019) (granting government’s motion to dismiss); United States ex rel. SAPF, LLC v. Amgen, Inc., No. 16-CV-5203 (E.D. Pa. Feb. 11, 2019) (dismissing case on voluntary consent of the government and relators); United States ex rel. SCEF, LLC v. AstraZeneca PLC, No. 17-CV-1328, 2019 WL 5725182, at *4 (W.D. Wash. Nov. 5, 2019) (granting government’s motion to dismiss); United States ex rel. Miller v. AbbVie, Inc., No. 16-CV-2111 (N.D. Tex. May 09, 2019) (dismissing case on voluntary consent of relator and the government); United States ex rel. Carle v. Otsuka Holdings Co., No. 17-CV-966 (N.D. Ill. Jan. 29, 2019) (dismissing case on voluntary consent of the government and relators); United States ex rel. SMSF, LLC v. Biogen, Inc., No. 16-CV-11379 (D. Mass. Dec. 17, 2018) (granting defendant’s unopposed motion to dismiss for failure to state a claim); United States ex rel. Health Choice Advocates, LLC v. Gilead, et al., No. 5:17- CV-121 (E.D. Tex. July 27, 2018) (dismissing case on voluntary consent of relator and the government).

3 Case: 19-40906 Document: 00515928635 Page: 4 Date Filed: 07/07/2021

in the United States District Court for the Eastern District of Texas. 2 Prior to filing these complaints, Health Choice submitted pre-filing notices to and met with attorneys from the United States Attorney’s Office for the Eastern District of Texas. After filing the complaints, Health Choice met with officials at the Department of Justice Civil Division in Washington, D.C. The United States declined to intervene in either case. Health Choice then amended each of its complaints. Shortly thereafter, Eli Lilly, Bayer, and the other defendants filed motions to dismiss for failure to state a claim. See Fed. R. Civ. P. 9(b), 12(b)(6). The magistrate judge held a consolidated hearing on the motions to dismiss in both cases. The magistrate judge recommended the motions be denied in part and granted in part, and the district court adopted these recommendations. Health Choice amended its complaints once more to address the pleading deficiencies identified by the district court. In October of 2018, approximately a year after declining to intervene in the Eli Lilly and Bayer cases, the government sent notice to Health Choice that it intended to move to dismiss the complaints. See 31 U.S.C. § 3730(c)(2)(A). Over the next two-and-a-half months, Health Choice and the government conferred by meeting, letter, and teleconference to discuss the government’s stated concerns about the case. During a teleconference with Health Choice, the government identified four specific concerns about

2 In its negotiations with the government, Health Choice agreed to voluntarily dismiss its claims against the non-pharmaceutical defendants in the Eli Lilly case in order to “streamline” the case and reduce the administrative burden on the government. In January of 2019, Health Choice dismissed its claims, without prejudice, against all the defendants except Eli Lilly in the Eli Lilly case. Health Choice did not voluntarily dismiss any claims in the Bayer case. Amgen, Inc., Onyx Pharmaceuticals, Inc., AmerisourceBergen Corp., and Lash Group remain codefendants in the Bayer case. For simplicity, we refer only to Eli Lilly and Bayer.

4 Case: 19-40906 Document: 00515928635 Page: 5 Date Filed: 07/07/2021

the Eli Lilly and Bayer cases: “(1) whether there [was] sufficient factual and legal support to prove violations of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b

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4 F.4th 255, Counsel Stack Legal Research, https://law.counselstack.com/opinion/health-choice-alliance-v-eli-lilly-ca5-2021.