Mallinckrodt plc

CourtUnited States Bankruptcy Court, D. Delaware
DecidedOctober 19, 2021
Docket20-12522
StatusUnknown

This text of Mallinckrodt plc (Mallinckrodt plc) is published on Counsel Stack Legal Research, covering United States Bankruptcy Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mallinckrodt plc, (Del. 2021).

Opinion

IN THE UNITED STATES BANKRUPTCY COURT FOR THE DISTRICT OF DELAWARE

In re: ) Chapter 11 ) MALLINCKRODT PLC, et al., ) Case No. 20-12522 (JTD) ) (Jointly Administered) ) Debtors. ) Re: Docket No. 4054

MEMORANDUM OPINION AND ORDER

On April 30, 2021, Attestor Limited, on behalf of itself and its affiliated entities, (“Attestor”), and Humana, Inc. (“Humana”) (collectively the “Acthar Insurance Claimants” or “AICs”), creditors of the Debtors, filed a Motion for Entry of an Order Allowing Administrative Expense Claims pursuant to Section 503(b) of the Bankruptcy Code (the “Administrative Expense Motion”).1 The Debtors objected to the Administrative Expense Motion (the “Objection”),2 and on August 31, 2021, filed a Motion for Partial Summary Judgment on the Objection (the “Motion”).3 The Motion was fully briefed,4 and a hearing was held on September 22, 2021. For the reasons set forth below, and as I ruled at the hearing held on September 29, 2021, the Motion is denied. BACKGROUND I. The Parties The Debtors operate a global specialty biopharmaceutical company that produces and sells both generic and branded pharmaceutical products.5 The Debtors’ flagship product and the

1 D.I. 2159. See also D.I. 2496, 3399, and 4436, indicating that since the Administrative Expense Motion was filed, Attestor has acquired the rights to the claims of other insurers, including United Healthcare, CVS, and Aetna. 2 D.I. 3529. 3 D.I. 4054. 4 D.I. 4054, 4243, 4301. 5 Declaration of Stephen A. Welch, Chief Transformation Officer, In Support of Chapter 11 Petitions and First Day Motions, D.I. 128. most valuable product in their portfolio is H.P. Acthar Gel (“Acthar”). Acthar is a natural adrenocorticotropic hormone (ACTH) drug that is used in the treatment of infantile spasms, lupus, rheumatoid arthritis, and certain ophthalmic conditions such as uveitis.6 At more than $38,000 per vial, sales of Acthar represent 30% of the Debtors’ overall business. Perhaps

unsurprisingly, the high price of Acthar has spawned several lawsuits, which I will discuss in detail below. While relatively small in number, the Acthar-related lawsuits assert as much as $15 billion in liabilities. In addition to Acthar and other less controversial drugs, the Debtors also produce and sell opioids. With the rise of the opioid abuse and overdose crisis in this country, the Debtors saw an onslaught of lawsuits asserting claims that the Debtors overstated the benefits of opioids while understating their risks and marketed the drugs in a manner that increased addiction, misuse, and abuse. As of the Petition Date, the Debtors had been named in over 3,000 such suits. Defending this number of lawsuits fast became cost prohibitive and impacted the Debtors’ ability to finance all of their businesses, contributing in large part to their need to reorganize.

The AICs are plaintiffs in some of the Acthar-related lawsuits.7 The AICs provide healthcare services, including insuring the risk of prescription drug costs, to more than seventeen million members throughout the United States.8 Since 2010, the AICs have paid billions of dollars for prescriptions for Acthar for their members.9

6 Id. 7 In addition to lawsuits initiated by insurance companies who pay for Acthar prescribed to their patients, there are also lawsuits initiated by private or “third party” payors. Those plaintiffs are not seeking to have administrative expense claims allowed here. 8 D.I. 2159 at 2. 9 D.I. 2159, 2496, 3399, and 4436. II. The Acthar-Related Prepetition Lawsuits On August 8, 2019, the AICs initiated litigation against Mallinckrodt alleging that the Debtors engaged in “one of the most outrageous price-gouging schemes in the history of American medicine.”10 This alleged scheme began in 2001, when Mallinckrodt’s predecessor

Questcor Pharmaceuticals, Inc. acquired the exclusive right to manufacture and sell Acthar from Aventis Pharmaceuticals for $100,000. Because the drug was expensive to make, had limited uses and was not fetching a high price, Aventis had been considering discontinuing production of Acthar.11 At the time of the acquisition, Acthar was sold for $40 a vial.12 The Complaint alleges that immediately after their acquisition of Acthar, the Debtors began to increase the price of the drug, raising it immediately to $750, then to $1,650 shortly thereafter and again in 2007, at which time it jumped up to $23,269 per vial. The price was then increased eight more times between 2007 and 2018, until the price reached $38,892 per vial. Since treatment with Acthar usually requires at least three vials, a single course of treatment can cost nearly $120,000.13

The Complaint alleges that the Debtors were able to effectuate this price increase and maintain it through three types of improper conduct. First, they eliminated the competition by acquiring and then allegedly shelving the rights to Acthar’s synthetic equivalent, a drug called Synacthen Depot (“Synacthen”). The Debtors allegedly outbid the competition for the right to

10 Second Amended Complaint, Humana v. Mallinckrodt ARD LLC, Case No. 2:10-cv-06926 (C.D. CA) (the “Complaint”), D.I. 2159, Ex. B. Though the suit was initiated by Humana alone, as discussed above, Humana has since entered into agreements with other insurers to share in the proceeds of any damages awards arising out of this action. Accordingly, for ease of reference in this Opinion, I will refer to the allegations as made by the AICs. Likewise, though the suit only named Mallinckrodt ARD and the AICs proofs of claim are only against Mallinckrodt ARD, for ease of reference in this Opinion I will refer to the defending party as “the Debtors.” 11 Id. 12 Id. 13 Id. Synacthen, but then “rather than undertake the process of obtaining FDA approval for the only drug that was a direct competitor of its best-selling product, Mallinckrodt never seriously attempted to bring Synacthen to market for any clinical use for which Acthar was approved,” keeping the price of Acthar artificially high.14 Second, the Debtors allegedly increased demand

for Acthar through the use of improper marketing techniques in violation of the False Claims Act, the Anti-Kickback Statute, and other laws. Third, the Debtors “maintained this artificially high demand through a pervasive bribery scheme to doctors.”15 While the AICs asserted multiple claims arising out of these allegations, including violations of state and federal antitrust laws, violations of the RICO Act, state unfair competition laws, state consumer fraud and deceptive trade practices laws, state insurance fraud claims, tortious interference claims, and unjust enrichment, the only claims at issue in this Motion are the antitrust claims (Counts I-III).16 Count I is a claim for violation of section 2 of the Sherman Antitrust Act, 15 U.S.C. § 2. Section 2 “makes it unlawful to monopolize, attempt to monopolize, or conspire to monopolize, interstate or international commerce.” United States v.

Grinnell Corp., 384 U.S. 563, 570-71 (1966); 15 U.S.C. § 2. The AICs allege that the Debtors violated section 2 by: (1) possessing monopoly power in the market for the sale of long-acting ACTH drugs in the United States; (2) intervening in the bidding process for Synacthen and purchasing the exclusive license to market Synacthen in the U.S., thereby eliminating the potential competitive threat posed by an independently owned Synacthen license (which contributed to the preservation of Mallinckrodt’s monopoly power and monopoly pricing); (3)

14 Id. 15 Id.

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