INTERNATIONAL UNION OF OPERATING ENGINEERS LOCAL 542 v. Mallinckrodt ARD, Inc. f/k/a Questcor Pharmaceuticals, Inc.

CourtDistrict Court, E.D. Pennsylvania
DecidedMarch 10, 2021
Docket2:21-cv-00114
StatusUnknown

This text of INTERNATIONAL UNION OF OPERATING ENGINEERS LOCAL 542 v. Mallinckrodt ARD, Inc. f/k/a Questcor Pharmaceuticals, Inc. (INTERNATIONAL UNION OF OPERATING ENGINEERS LOCAL 542 v. Mallinckrodt ARD, Inc. f/k/a Questcor Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
INTERNATIONAL UNION OF OPERATING ENGINEERS LOCAL 542 v. Mallinckrodt ARD, Inc. f/k/a Questcor Pharmaceuticals, Inc., (E.D. Pa. 2021).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

INTERNATIONAL UNION OF : OPERATING ENGINEERS : CIVIL ACTION LOCAL 542, : Plaintiff, : : v. : : MALLINCKRODT ARD, INC., et al., : No. 21-114 Defendants. :

MEMORANDUM

Schiller, J. March 10, 2021

This lawsuit is one of numerous cases filed throughout the country involving Mallinckrodt’s Acthar medication. In this particular case, Plaintiff claims that Defendants engaged in a scheme to raise the price of Acthar, couching all of their claims as violations of state law and filing this lawsuit in the Montgomery County Court of Common Pleas. Towards the end of 2020, years after this case began, Mallinckrodt filed for bankruptcy. Shortly thereafter, Mallinckrodt filed a notice of removal arguing that its bankruptcy filing brings this litigation within this Court’s subject matter jurisdiction. Mallinckrodt seeks to transfer this matter to the District of Delaware so that the Bankruptcy Court can address Plaintiff’s claims. Plaintiff wants the Court to remand the case back to state court. The Court will transfer this case to the District of Delaware with the expectation that the case will be sent to the Bankruptcy Court in that District. The Bankruptcy Court should decide whether Plaintiff’s claims will remain before it or will be remanded to state court. Therefore, the Court will deny without prejudice the motion to remand and will grant the motion to transfer to allow the Bankruptcy Court to determine how best to proceed. I. BACKGROUND

This litigation commenced in the Montgomery County Court of Common Pleas on May 25, 2018.1 The gist of this case, as stated in the notice of removal, is that Defendants allegedly engaged in an unlawful scheme to raise the price of Mallinckrodt’s pharmaceutical product, Acthar Gel. In addition to Mallinckrodt, the lawsuit names Express Scripts Holding Co., Express Scripts, Inc. CuraScript, Inc. d/b/a CuraScript SP Specialty Pharmacy, Priority Healthcare Distribution, Inc. d/b/a CuraScript SD Specialty Distribution, Accredo Health Group, Inc., and United BioSource LLL f/k/a United BioSource Corp. (collectively, the “Express Scripts Entities” and together with Mallinckrodt, “Defendants”). Mallinckrodt makes, markets, distributes, and sells Acthar, the only therapeutic adrenocorticotropic hormone product sold in the United States. (Mallinckrodt Defs.’ Notice of Removal Ex. 1a [Compl.] ¶ 2.) Acthar is a “specialty pharmaceutical,” which means that it is distributed only though “specialty pharmacy distributors” (“SPD”) and “specialty pharmacy providers.” (Id. ¶ 6.) One of the largest SPD is Defendant Express Scripts, Inc.’s CuraScript, which

is also a defendant. (Id. ¶¶ 7, 28.) The International Union of Operating Engineers Local 542 represents heavy equipment operators in the building and construction industry. (Id. ¶ 19.) It provides health and welfare benefits to its members and their families. (Id. ¶ 18.) Three of those members use Acthar to treat medical conditions. (Id. ¶ 20.) Those members received their Acthar from Express Scripts; Plaintiff pays the health care benefits of its members and paid for the Acthar for those three members. (Id.)

1 An amended complaint was filed on August 27, 2018, though it did not substantively change the factual allegations from the original complaint. The Court will briefly describe the history of Acthar’s development, distribution, and pricing as outlined in the Complaint. Acthar was approved by the FDA in 1952, and it is currently approved to treat nineteen different conditions. (Id. ¶ 41.) Although Acthar previously enjoyed a broad distribution network, Mallinckrodt significantly restricted that network in 2007 to just Express Scripts, the agent of Mallinckrodt’s largest customers. (Id. ¶¶ 24, 30 (“CuraScript is

Mallinckrodt’s exclusive SPD for Acthar.”); see also id. 48-49.) “All aspects of Acthar distribution were handled by Express Scripts.” (Id. ¶ 49.) Mallinckrodt manages this exclusive arrangement with Express Scripts through the Acthar Support and Access Program. (Id. ¶ 51.) The Acthar Support and Access Program is operated by Defendant United BioSource Corporation (“UBC”), which manages Express Scripts’s exclusive distribution, sales, and reimbursement of Acthar. (Id. ¶ 35.) “In effect, Mallinckrodt contracted with the agent of its leading customers, and the largest SPD at the time, in order to create an exclusive arrangement whereby both companies would share the financial rewards of the Acthar monopoly through exorbitantly higher prices.” (Id. ¶ 8.) After Mallinckrodt and Express Scripts agreed to this exclusive arrangement, the two companies agreed

to significantly raise the price of Acthar. This agreement forced Plaintiff to pay much higher prices for Acthar. (Id. ¶ 10.) For example, three members of Plaintiff had a serious medical condition for which Acthar was indicated as a treatment option. (Id. ¶ 20.) These members received Acthar from Express Scripts. (Id.) Plaintiff paid $153,775.95 directly to Express Scripts for its members’ Acthar. (Id. ¶ 22.) This money was then transferred to Mallinckrodt, after Express Scripts deducted its share of the revenues. (Id.) According to the Complaint, “[o]nce the patient (or their physician) contacts Mallinckrodt for a prescription of Acthar, they are directed to UBC. UBC then serves as the self-described ‘hub’ for Mallinckrodt and Express Scripts’ exclusive arrangement. It confirms the patient’s insurance coverage or other source of payment, and then arranges for Acthar to be delivered directly to the patient by CuraScript.” (Id. ¶¶ 52, 61.) As the Complaint phrases it, CuraScript acts as a delivery service for specialty prescription drugs. (Id. ¶ 62.) Plaintiff also coordinates with Defendant Accredo, another SPD, to get Acthar to its members. (Id. ¶ 68.) “In reality, however, the use of Accredo only insured that [Plaintiff] would pay the inflated prices for Acthar that Express Scripts

agreed with Mallinckrodt to charge.” (Id. ¶ 66.) When a doctor submitted a prescription to the Acthar Support and Access Program using the Acthar Start Form, which was used to coordinate reimbursement and to direct the prescription to Accredo, the Program would deal with Plaintiff’s members. (Id. ¶ 68.) The member has insurance coverage through a health plan, which has a contract with Express Scripts to provide Plaintiff’s members with pharmacy benefit management services and which requires Express Scripts to collect payment for the price of Acthar as a specialty drug. (Id. ¶¶ 71, 78.) Plaintiff charges that Mallinckrodt has used its monopoly power to limit the distribution of a specialty drug to one SPD, CuraScript, and used CuraScript’s agents to coordinate all aspects of the distribution and sales of Acthar. (Id. ¶ 74.) “This allowed Mallinckrodt to raise

its prices tenfold initially, and nearly double in the ensuing years, without any pushback from Express Scripts.” (Id.) Express Scripts serves as Plaintiff’s exclusive specialty pharmacy provider and distributor, in an effort to contain costs. (Id. ¶¶ 79-80.) Express Scripts failed to disclose to Plaintiff its exclusive relationship with Mallinckrodt. (Id. ¶ 81.) It failed to act to lower costs despite regularly touting its ability to do so. (Id. ¶¶ 102-04.) When Mallinckrodt acquired the rights to Acthar in 2001, the end-payor price of a vial was $40. (Id. ¶ 92.) After it acquired the rights to Acthar, the price per vial rose to $748. (Id.) From 2001 until Mallinckrodt executed its new strategy in 2007, the end-payor price was $1980. (Id.) When it implemented its new strategy in August of 2007, the price skyrocketed to $27,922.80 per vial, a 69,707% increase from the time Mallinckrodt acquired Acthar. (Id. ¶ 93.) By 2012, the end payor paid $34,150 per vial and by 2017, Acthar cost $43,658.40 per vial. (Id.

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INTERNATIONAL UNION OF OPERATING ENGINEERS LOCAL 542 v. Mallinckrodt ARD, Inc. f/k/a Questcor Pharmaceuticals, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/international-union-of-operating-engineers-local-542-v-mallinckrodt-ard-paed-2021.