Astellas US Holding, Inc. v. Starr Indemnity and Liability Company

CourtDistrict Court, N.D. Illinois
DecidedMay 30, 2018
Docket1:17-cv-08220
StatusUnknown

This text of Astellas US Holding, Inc. v. Starr Indemnity and Liability Company (Astellas US Holding, Inc. v. Starr Indemnity and Liability Company) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Astellas US Holding, Inc. v. Starr Indemnity and Liability Company, (N.D. Ill. 2018).

Opinion

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

ASTELLAS US HOLDING, INC., and ASTELLAS PHARMA US, INC.,

Plaintiffs, No. 17 CV 8220 v. Judge Manish S. Shah STARR INDEMNITY AND LIABILITY COMPANY, BEAZLEY INSURANCE COMPANY, INC., and FEDERAL INSURANCE COMPANY,

Defendants.

MEMORANDUM OPINION AND ORDER

The government issued a subpoena to Astellas Pharma, Inc., demanding the production of documents, and later entered into an agreement with Astellas Pharma US to toll the statute of limitations on possible violations of criminal law. Plaintiffs Astellas US Holding and Astellas Pharma US bring this action against their insurers, Starr Indemnity and Liability Company, Beazley Insurance Company, and Federal Insurance Company, for denying coverage for the expenses incurred in response to the government’s investigation. Each of the defendants move to dismiss plaintiffs’ amended complaint because, they say, the policies cover losses from claims for wrongful acts and neither the subpoena nor the tolling agreement count as covered claims. For the following reasons, those motions are denied. I. Legal Standards A motion to dismiss under Rule 12(b)(1) challenges the court’s subject-matter jurisdiction. Fed. R. Civ. P. 12(b)(1). The plaintiff bears the burden of establishing

the elements necessary for subject-matter jurisdiction. Scanlan v. Eisenberg, 669 F.3d 838, 841–42 (7th Cir. 2012). By contrast, a Rule 12(b)(6) motion “tests whether the complaint states a claim on which relief may be granted.” Richards v. Mitcheff, 696 F.3d 635, 637 (7th Cir. 2012). The complaint must contain factual allegations that plausibly suggest a right to relief. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). When analyzing a motion under Rule 12(b)(1) or Rule 12(b)(6), the court accepts all well-pleaded factual allegations as true and draws all reasonable inferences in favor

of the plaintiff. Scanlan, 669 F.3d at 841; Virnich v. Vorwald, 664 F.3d 206, 212 (7th Cir. 2011). The court need not accept legal conclusions or conclusory allegations, however. Virnich, 664 F.3d at 212. II. Background Historically, pharmaceutical companies sponsored patient assistance programs that subsidized the purchase of drugs for certain Medicare beneficiaries.

[39] ¶ 19.1 For example, plaintiffs made charitable contributions to organizations that assisted financially needy patients, and some of those patients may have taken drugs sold by plaintiffs. Id. ¶ 26. The Department of Health and Human Services, Office of Inspector General, announced that these programs risked violating the anti-kickback statute, and beginning January 1, 2006, Medicare Part D

1 Bracketed numbers refer to entries on the district court docket. Page numbers are taken from the CM/ECF header placed at the top of filings. beneficiaries would no longer be eligible to participate in patient assistance programs. Id.¶ 19. In May 2014, the OIG issued a supplemental bulletin to provide additional guidance regarding patient assistance programs that were operated by

independent charities and that provided cost-sharing assistance for prescription drugs. Id. ¶ 20. On March 3, 2016, the United States Department of Justice issued a subpoena to plaintiffs demanding certain documents relating to the DOJ’s industry- wide investigation of pharmaceutical companies for alleged “Federal health care offenses.” Id. ¶ 21. The subpoena commanded plaintiffs to appear before government officials and to produce documents about plaintiffs’ payments to

charitable organizations that provided financial assistance to patients taking plaintiffs’ drugs. Id. ¶ 24; [39-4]. It advised plaintiffs that failure to comply exposed them to liability in judicial enforcement proceedings and punishment for disobedience. [39-4]. Although the DOJ formally addressed the subpoena to Astellas Pharma, Inc., plaintiffs’ Japanese parent company, the subpoena also used the term “You,” which the subpoena defined as including the parent company’s subsidiaries.

[39] ¶ 22; see also [39-4]. Astellas Pharma US, the U.S.-based subsidiary, was the only relevant entity for purposes of the subpoena because plaintiffs’ parent company never provided charitable contributions to the patient assistance programs at issue in the subpoena.2 [39] ¶ 22.

2 The complaint also alleges that the DOJ entered into an agreement with plaintiffs that the subpoena would apply to plaintiffs, not just plaintiffs’ parent company. [39] ¶ 22. Although the government’s position is not stated in the subpoena, the DOJ alleged that plaintiffs’ contributions to independent charity patient assistance programs violated applicable law. Id. ¶¶ 27–29. The investigation is ongoing; and

the DOJ has subpoenaed additional documents from plaintiffs. Id. ¶ 30. On October 26, 2017, the DOJ entered into a “Limited Tolling Agreement on Statute of Limitations” with Astellas Pharma US, which states that the DOJ “is currently conducting a joint criminal and civil investigation of [] Astellas, and its officers, employees, and agents,” and that “[t]he conduct being investigated includes, without limitation, the possible violation by Astellas . . . of various federal criminal statutes . . . in connection with Astellas’s payments to ‘501(c)(3)’ organizations that

provide financial assistance to Medicare beneficiaries.” Id. ¶ 31; see also [21-4]. The parties agreed to toll the applicable statutes of limitation for Astellas’s possible violations of law in making payments to organizations that gave financial assistance to Medicare beneficiaries. [21-4]. After receiving the first subpoena, plaintiffs provided each of the defendants—the insurance companies—timely written notice of the subpoena. [39]

¶ 34. Plaintiffs’ primary insurance policy came from Starr; that policy had a $5 million limit of liability excess of a $500,000 self-insured retention, id. ¶ 11, and it provided: “The Insurer shall pay on behalf of the Company the Loss arising from a Claim first made during the Policy Period . . . against the Company for any Wrongful Act, and reported to the Insurer in accordance with the terms of this policy,” [39-1] at 18. In addition to its primary policy with Starr, plaintiffs also had excess insurance policies with Beazley and Federal Insurance. Beazley’s policy provided a $5 million limit of liability excess of the Starr policy’s $5 million limit of liability and the applicable $500,000 self-insured retention. [39] ¶ 17. In order for

the Beazley policy to apply, all of the underlying limits had to have been exhausted through payments of amounts covered under the Starr policy. Id. Federal provided a $10 million limit of liability excess of the Starr policy’s and the Beazley policy’s combined limits of $10 million and the applicable $500,000 self-insured retention. Id. ¶ 18. The Federal policy only covers a loss if all of the underlying limits have been exhausted through payments of amounts covered under the Starr and Beazley policies. Id.

In response to plaintiffs’ notice of the subpoena, Beazley reserved its rights, noting that “[a]s an excess carrier, Beazley cannot have any coverage obligations until the underlying layer is exhausted,” id. ¶ 35, and Federal acknowledged receipt of the notice, but stated that “it must reserve the right to raise all of the defenses available to it under the policy and the law,” id. ¶ 36.

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Astellas US Holding, Inc. v. Starr Indemnity and Liability Company, Counsel Stack Legal Research, https://law.counselstack.com/opinion/astellas-us-holding-inc-v-starr-indemnity-and-liability-company-ilnd-2018.