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Gary S. Lincenberg Jeremy D. Matz BIRD, MARELLA, BOXER

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Gary S. Lincenberg Jeremy D. Matz BIRD, MARELLA, BOXER Case 2:19-cv-06926-CAS-MRW Document 1 Filed 08/08/19 Page 1 of 49 Page ID #:1 1 Gary S. Lincenberg Jeremy D. Matz 2 BIRD, MARELLA, BOXER, WOLPERT, NESSIM, DROOKS, LINCENBERG & RHOW P.C. 3 1875 Century Park East, 23rd Floor Los Angeles, CA 90067 4 Telephone: 310−201−2100 Fax: 310−201−2110 5 Email: [email protected] [email protected] 6 Scott C. Solberg (pro hac vice application forthcoming) 7 James W Joseph (pro hac vice application forthcoming) Benjamin E. Waldin (pro hac vice application forthcoming) 8 EIMER STAHL LLP 224 South Michigan Ave., Suite 1100 9 Chicago, IL 60604 Telephone: (312) 660-7600 10 Fax: (312) 692-1718 Email: [email protected] 11 [email protected] [email protected] 12 Attorneys for Plaintiff Humana Inc. 13 14 UNITED STATES DISTRICT COURT 15 CENTRAL DISTRICT OF CALIFORNIA, WESTERN DIVISION 16 17 HUMANA INC., 18 Plaintiff, 19 v. 20 Case No. ______________________2:19-cv-06926 21 MALLINCKRODT ARD LLC (f/k/a DEMAND FOR JURY TRIAL 22 Mallinckrodt ARD Inc., f/k/a Questcor 23 Pharmaceuticals, Inc.), and 24 MALLINCKRODT PLC, 25 Defendants. 26 27 28 COMPLAINT Case 2:19-cv-06926-CAS-MRW Document 1 Filed 08/08/19 Page 2 of 49 Page ID #:2 1 TABLE OF CONTENTS 2 I. INTRODUCTION ............................................................................................ 1 3 II. PARTIES .......................................................................................................... 5 4 III. JURISDICTION AND VENUE ....................................................................... 9 5 IV. FACTUAL ALLEGATIONS ......................................................................... 10 6 A. Humana ........................................................................................................ 10 7 B. Acthar .......................................................................................................... 12 8 C. Mallinckrodt’s Monopoly Power with Acthar ............................................ 13 9 1. Direct Evidence of Monopoly Power .......................................................... 13 10 2. Further Evidence of Monopoly Power ........................................................ 14 11 3. Anticompetitive Conduct in the Acquisition of Synacthen ........................ 16 12 4. Mallinckrodt’s Sales of Acthar to Humana and its Members ..................... 18 13 5. Scope of the Antitrust Allegations .............................................................. 20 14 D. Mallinckrodt’s Kickback and Racketeering Schemes................................. 20 15 1. Patient Co-Pay Subsidies Through Sham Charitable Funds ....................... 20 16 2. Physician Kickbacks .................................................................................... 25 17 3. False Representations and Certifications .................................................... 27 18 4. Use of the Mails and Wires ......................................................................... 29 19 E. Mallinckrodt’s Fraudulent Concealment of the Illegal Scheme ................. 29 20 F. Damages ...................................................................................................... 30 21 Count I Violation of the Sherman Antitrust Act, 15 U.S.C. § 2 ............................. 31 22 Count II Violation of the Sherman Antitrust Act, 15 U.S.C. § 1 ........................... 32 23 Count III Violation of State Antitrust Laws ............................................................ 32 24 Count IV Violation of the RICO Act, 18 U.S.C. § 1962(c) .................................... 34 25 Count V Conspiracy to Violate the RICO Act, 18 U.S.C. § 1962(d) ...................... 36 26 Count VI State Unfair Competition Law Claims..................................................... 38 27 Count VII State Consumer Fraud and Deceptive Trade Practice Law Claims ....... 40 28 Count VIII State Insurance Fraud Claims ............................................................... 43 i COMPLAINT Case 2:19-cv-06926-CAS-MRW Document 1 Filed 08/08/19 Page 3 of 49 Page ID #:3 1 Count IX Tortious Interference with Contractual Relations .................................... 44 2 Count X Unjust Enrichment ..................................................................................... 45 3 V. PRAYER FOR RELIEF ................................................................................. 45 4 VI. JURY DEMAND ............................................................................................ 46 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ii COMPLAINT Case 2:19-cv-06926-CAS-MRW Document 1 Filed 08/08/19 Page 4 of 49 Page ID #:4 1 COMPLAINT 2 Plaintiff Humana Inc. (“Plaintiff” or “Humana”), complains against Defendants 3 Mallinckrodt ARD LLC, formerly known as Questcor Pharmaceuticals, Inc. 4 (“Questcor”), and its parent corporation Mallinckrodt plc (collectively “Defendants,” 5 “Mallinckrodt,” or the “Company”), as follows: 6 I. INTRODUCTION 7 1. This action arises from one of the most outrageous price-gouging schemes 8 in the history of American medicine. 9 2. H.P. Acthar Gel (“Acthar”) is a drug that has been available since 1952, 10 and for nearly half a century, its price was modest. In 2001, a vial of the drug cost $40. 11 3. But by 2018, the same vial cost over $39,000. This is a 97,500% price 12 increase. It is as if the price of milk increased from $3 to over $2,900 per gallon, or a 13 mortgage payment rose from $2,000 to over $2 million per month. 14 4. These eye-popping price increases are not an accident, a market anomaly, 15 or a necessary byproduct of legislation. They are the intended result of purposeful and 16 illegal conduct by Acthar’s producers, Mallinckrodt and its predecessor Questcor. This 17 conduct consists of a complex, multipart scheme involving monopoly, bribery, 18 racketeering, fraud, and other deceptive and unfair practices that have imposed 19 exorbitant and pointless costs on those financially responsible for the costs of the drug, 20 including not just patients but also health and Medicare insurers like Humana, the 21 plaintiff here. 22 5. Though Acthar may be a billion-dollar golden goose for Mallinckrodt 23 today, its origins were humble. The drug is an adrenocorticotropic hormone (“ACTH”) 24 analogue produced from the pituitary gland of pigs. It was invented in the late 1940s by 25 the meat company Armour, as a byproduct of pork-processing operations. At the time, 26 Acthar was considered a miracle drug because it stimulated the body’s production of 27 cortisol, provoking a natural anti-inflammatory response that was beneficial for the 28 treatment of various conditions. Acthar was given broad approval by the FDA in 1952 1 COMPLAINT Case 2:19-cv-06926-CAS-MRW Document 1 Filed 08/08/19 Page 5 of 49 Page ID #:5 1 to treat a wide range of ailments at a time when such broad approvals were 2 commonplace and did not require support from clinical trials. 3 6. This also occurred before the commercial development of synthetic steroid 4 drugs (corticosteroids) and many popular non-steroidal anti-inflammatory drugs 5 (NSAIDs), such as ibuprofen. The advent of these safe, cheap alternative treatments in 6 pill form reduced the need for an injectable drug derived from the pituitary gland of 7 pigs. By the 1990s, only a few key uses remained for Acthar. For example, Acthar 8 remains the standard of care for infantile spasms, a rare but catastrophic epileptic 9 syndrome affecting babies and toddlers two years old or younger. But other than this 10 and a handful of similarly rare conditions, Acthar is—especially for older patients who 11 are Medicare beneficiaries, such as Humana members—either a drug of last resort or 12 not known to be clinically effective. 13 7. Consequently, the drug became unprofitable for its manufacturer, Aventis 14 Pharmaceuticals, Inc., which had considered stopping production. But the drug was 15 saved in 2001, when Mallinckrodt’s predecessor Questcor purchased the right to 16 produce this unprofitable and largely outdated drug for $100,000 plus modest royalties, 17 seeing it as a potential gold mine for exploitation. 18 8. Thereafter began a run of outrageous price increases. The cost of Acthar 19 ballooned from $40 in 2001, to $750 immediately after it was acquired, to $1,650 by 20 2007. In that year the price was jacked up to $23,269 per vial. But the increases did not 21 stop or reverse course: instead the price of Acthar was increased eight more times so 22 that by 2018, the drug cost $38,892 per vial. And since treatment with Acthar usually 23 requires at least three vials, a single course of treatment can cost nearly $120,000. The 24 following charts the course of Acthar pricing: 25 26 27 28 2 COMPLAINT Case 2:19-cv-06926-CAS-MRW Document 1 Filed 08/08/19 Page 6 of 49 Page ID #:6 1 2 3 4 5 6 7 8 9 10 11 12 9. In just over a decade, Acthar went from a nearly extinct, financial sinkhole 13 to a billion-dollar cash machine. In August 2014—in the midst of this meteoric price 14 rise—Questcor merged into Mallinckrodt in a deal worth approximately $5.6 billion. At 15 the time, Acthar was the only drug product sold by Questcor. 16 10. Mallinckrodt has been able to inflate and maintain the shocking price 17 increases of Acthar mainly through three types of improper conduct. 18 11. First, Mallinckrodt eliminated the competition. It did so by acquiring and 19 then shelving the rights to Acthar’s much cheaper synthetic equivalent ACTH, a drug 20 called Synacthen Depot (“Synacthen”). Drug giant Novartis AG (“Novartis”)
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