United Healthcare Services, Inc. v. AmerisourceBergen Corporation

CourtDistrict Court, D. Minnesota
DecidedApril 24, 2024
Docket0:23-cv-02890
StatusUnknown

This text of United Healthcare Services, Inc. v. AmerisourceBergen Corporation (United Healthcare Services, Inc. v. AmerisourceBergen Corporation) is published on Counsel Stack Legal Research, covering District Court, D. Minnesota primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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United Healthcare Services, Inc. v. AmerisourceBergen Corporation, (mnd 2024).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

United Healthcare Services, Inc., Civil No. 23-2890 (DWF/ECW)

Plaintiff,

v. MEMORANDUM AmerisourceBergen Corporation; OPINION AND ORDER AmerisourceBergen Drug Corporation; AmerisourceBergen Specialty Group, LLC; ASD Specialty Healthcare, LLC d/b/a Oncology Supply Company; and Medical Initiatives, Incorporated d/b/a Oncology Supply Pharmacy Services,

Defendants.

INTRODUCTION This matter is before the Court Defendants’ Motion to Dismiss Plaintiff’s Complaint (Doc. No. 27). For the reasons set forth below, the Court grants Defendants’ motion. BACKGROUND Plaintiff United Healthcare Services, Inc. (“UHS” or “Plaintiff”) is a Minnesota corporation that services commercial insurance and managed-care programs for members and beneficiary plans offered by its subsidiaries and affiliates. (Doc. No. 1 (“Compl.”) ¶ 26.) Defendant AmerisourceBergen Corporation (“AmerisourceBergen”) is a pharmaceutical sourcing and distribution company with a pharmaceutical distribution segment that includes subsidiaries AmerisourceBergen Drug Corporation (“ABC Drug”) and AmerisourceBergen Specialty Group, LLC (“ABC Specialty”) (collectively, “ABC” or “ABC Defendants”). (Id. ¶¶ 28-30.) ABC Specialty provides oncology distribution and related serves to hospitals and oncology centers nationwide. (Id. ¶ 30.) Defendant

ASD Specialty Healthcare, LLC d/b/a Oncology Supply (“Oncology Supply”), formerly a division or subsidiary of ABC Specialty, was a pharmaceutical wholesaler but is no longer in business. (Id. ¶ 31.) Defendants Medical Initiatives, Inc. d/b/a Oncology Supply Pharmacy Services (“MII”) operated out of Oncology Supply’s Alabama facility and was acquired by AmerisourceBergen in 2001. (Id. ¶ 32.)

Plaintiff alleges that between 2001 and 2014, AmerisourceBergen, along with its Defendant subsidiaries, perpetrated an unlawful scheme (the “Program” or “PFS Program”) to distribute and sell doses of adulterated oncology drugs to be administered to patients in Minnesota and nationwide, many that were insured under programs operated by UHS.1 The Program involved MII, which created pre-filled syringes (“PFS”) of

oncology drugs for ABC Specialty to sell or distribute to healthcare providers. (Id. ¶ 32.) Plaintiff further alleges that AmerisourceBergen did not register MII with the FDA as required by law as a manufacturer or re-packager of prescription medications and that MII did not act as a pharmacy selling the PFSs. (Id.) Under the Program, when filling a healthcare provider’s order for a PFS, MII

would draw the product from vials produced by the manufacturer into a syringe for

1 The PFS Program operated between 2001 and 2014. (Compl. ¶¶ 2, 128, 205.) MII ceased operations on January 31, 2014. See Teamsters Local 442 Health Servs. & Ins. Plan v. Chou, Civ. No. 2019-0816, 2023 WL 7986729, at *17 (Del. Ch. Nov. 17, 2023). shipping to the customer and would then keep any excess product (the “overfill”). (Id. ¶ 139.) MII would then use the overfill to fill later prescriptions. (Id.) Per the Complaint, MII breached sterile vials of oncology drugs, pooled their contents, and

created PFSs in Oncology Supply’s unsterile facilities in Alabama. (Id. ¶¶ 125, 128.) The practice of pooling and repackaging the overfill from syringes for clinical use was common in the industry, but Plaintiffs allege that MII’s equipment and quality controls were in violation of federal manufacturing requirements and therefore that the syringes were “adulterated, dangerous, tainted, effectively worthless, and had no market

value.” (Id. ¶¶ 7, 9.) In addition, Plaintiffs allege the products’ FDA-approved labels were false and misleading and violated CDC safety standards. (Id.) Also according to the Complaint, Defendants pushed physicians to purchase PFSs for a medicine called Procrit by paying them “kickbacks” in the form of rebates that violated federal and state law. (Id. ¶¶ 14, 112, 130.)

UHS reimbursed claims filed by providers or patients for syringes administered to UHS insureds. UHS acknowledges that Defendants did not themselves submit claims for payment to government healthcare programs or insurers. (Id. ¶ 151.) Instead, physicians and other healthcare providers who purchased PFSs from Defendants sought reimbursement from UHS.

The PFS Program was the subject of prior civil actions and government investigations. Beginning in 2010, these investigations were disclosed in Defendants’ filings with the Securities and Exchange Commission (“SEC”) and in other public sources. One such action began in October 2010, when a former employee of ABC Specialty filed under seal a qui tam action under the False Claims Act, 31 U.S.C. § 3730(b), relating to MII and the PFS Program.2 (Compl. ¶ 114.) AmerisourceBergen disclosed the existence of this action in its publicly filed SEC annual report, noting that

the action involved allegations of kickbacks by the oncology distribution business. (Doc. No. 30 (“Mundel Decl.”) ¶ 4, Ex. 2, AB Form 10-K at 3.3 In 2012, AmerisourceBergen disclosed in its annual report that the Alabama facility where MII and Oncology Supply were located was the subject of a related government investigation. (Id. ¶ 5, Ex. 3, AB Form 10-K at 3.) Further, there was media coverage of the investigation, which involved

a raid of the Alabama facility by the Department of Health and Human Services and the FDA. (Id. ¶ 10, Ex. 8, Timothy W. Martin et al., Wholesaler Subpoenaed Over Controlled Drugs, Wall Street Journal (Aug. 9, 2012) (reporting that AmerisourceBergen received a subpoena “over an oncology supply distribution center and pharmacy in Dothan, [Alabama]” and that investigators served a search warrant at the facility.)4

AmerisourceBergen continued to disclose that the Alabama facility was under federal investigation in its 2013 and 2014 annual reports. (Id. ¶ 6, Ex. 4, AB Form 10-K at 3;

2 The U.S. Attorney intervened in the qui tam action on August 31, 2017, and the action was unsealed on October 1, 2018. (Compl. ¶ 114.) 3 The Court takes judicial notice of SEC filings, as well as materials posted on government websites. See, e.g., In re Resideo Techs., Inc., Sec. Litig., Civ. No. 19-2863, 2021 WL 1195740, at *3 (D. Minn. Mar. 30. 2021); United States v. Garcia, 855 F.3d 615, 621,22 (4th Cir. 2017). 4 The Court takes judicial notice of news reports to the extent that a report demonstrates that certain information was publicly available at a certain time. See, e.g., Von Saher v. Norton Simon Museum of Art at Pasadena, 592 F.3d 954, 960 (9th Cir. 2010). ¶ 7, Ex. 5, AB Form 10-K at 3.) In 2015, AmerisourceBergen again specifically noted that the investigation related to the “former pharmacy’s pre-filled syringe program.” (Id. ¶ 8, Ex. 6, AB Form 10-K at 3. Specifically, AmerisourceBergen stated:

Since fiscal 2012, the Company and AmerisourceBergen Specialty Group (“ABSG”) have been responding to subpoenas from the United States Attorney’s Office for the Eastern District of New York (“USAO-EDNY”) requesting production of documents and information relating to ABSG’s oncology distribution center and former pharmacy in Dothan, Alabama (including the practices and procedures of the former pharmacy’s pre-filled syringe program), its group purchasing organization for oncologists, and intercompany transfers of certain oncology products, which the Company believes could be related in whole or in part to one or more of the qui tam actions that remain under seal. The Company continues to engage in dialogue with the USAO-EDNY.

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