UNITED STATES DISTRICT COURT DISTRICT OF KANSAS ... - EpiPen

Case 2:17-md-02785-DDC-TJJ Document 60 Filed 10/17/17 Page 1 of 400

UNITED STATES DISTRICT COURT DISTRICT OF KANSAS

In re EPIPEN (EPINEPHRINE

)

INJECTION, USP) MARKETING,

)

SALES PRACTICES AND ANTITRUST )

LITIGATION

)

)

This Document Relates To:

)

CONSUMER CLASS CASES

)

)

)

(1) Local 282 Welfare Trust Fund, (2) Rosetta )

Serrano, (3) Lesley Huston, (4) Kenneth Evans,)

(5) Cassandra Bredek, (6) Christopher Rippy, )

(7) Nikitia Marshall, (8) Elizabeth Huelsman, )

(9) Kimberly Corcoran, (10) Stacee Svites, )

(11) Lauren Coale, (12) Rachel Fernandez, )

(13) Raymond Buchta III, (14) Lee Seltzer, )

(15) Kimberly Dollander, (16) Linda Wagner, )

(17) Denya Anderson, (18) Vishal Aggarwal, )

(19) Erin Korte-Lamparter, (20) Alene

)

McDaniel, (21) Joy Shepard, (22) Eileen

)

Montet, (23) Lorraine Wight, (24) Teia Amell, )

(25) Todd Beaulieu, (26) Anastasia Johnston, )

(27) Annette Sutorik, (28) Heather DeStefano, )

(29) Elizabeth Williamson, (30) Shannon

)

Clements, (31) Mark Kovarik, (32) Miriam )

Clarke, (33) Laura Chapin, (34) Maria

)

Giurland, (35) Michael Gill, (36) Suzanne )

Harwood, (37) Donna Wemple, (38) Cassandra )

Cobb, (39) Sonya North, (40) Christina James, )

(41) David H. Smith, (42) Lori Collins,

)

(43) Jae Jones, (44) Jennifer Walton, (45) April )

Sumner, (46) Meredith Krimmel, (47) Landon )

Ipson, (48) Kenneth Steinhauser, (49) John )

Dodge, (50) Amie Vialet De Montbel,

)

)

No. 2:17-md-02785-DDC-TJJ (MDL No: 2785)

CONSOLIDATED CLASS ACTION COMPLAINT

DEMAND FOR JURY TRIAL

[Caption continued on following page]

Case 2:17-md-02785-DDC-TJJ Document 60 Filed 10/17/17 Page 2 of 400

(51) Donna Anne Dvorak, (52) Connie

)

Stafford, (53) Francis Myers, (54) Heather )

Ruland, (55) Curt Palmer, (56) Angie

)

Nordstrum, and (57) Carly Bowersock,

)

Individually and on Behalf of All Others

)

Similarly Situated,

)

)

Plaintiffs,

)

)

vs.

)

)

(1) Mylan N.V., (2) Mylan Specialty L.P., )

(3) Mylan Pharmaceuticals, Inc., (4) Heather )

Bresch, (5) Pfizer, Inc., (6) King

)

Pharmaceuticals, Inc., and (7) Meridian

)

Medical Technologies, Inc.,

)

Defendants. )

)

CONSOLIDATED CLASS ACTION COMPLAINT

Case 2:17-md-02785-DDC-TJJ Document 60 Filed 10/17/17 Page 3 of 400

TABLE OF CONTENTS

INTRODUCTION......................................................................................................................... 6 PARTIES..................................................................................................................................... 10 JURISDICTION AND VENUE ................................................................................................. 28 BACKGROUND AND FACTUAL ALLEGATIONS............................................................... 28

A. Allergies, Anaphylaxis, and Epinephrine ............................................................. 28 B. The EpiPen............................................................................................................ 30 C. Pharmaceutical Industry Market Overview .......................................................... 34 D. Mylan's History of Anti-Competitive Conduct .................................................... 38 E. The EpiPen Scheme: Mylan's Predatory Monopolization, Racketeering,

Unconscionable Sales, and Deceptive and Unfair Trade Practices ...................... 44 1. Defendants' Illegal Acquisition and Maintenance of Mylan's Monopoly 44

a. Mylan Abuses the EpiPen Monopoly by Paying PBMs to Exclude Competition............................................................................................... 45 b. Defendants' Manipulate Access to Schools through Lobbying and Illegal Exclusive Dealing Arrangements to Enhance and Protect the EpiPen Monopoly ..................................................................................... 58 c. Mylan's Use of Misleading Advertising to Exclude Competition..... 66 d. Defendants' Illegal Pay-for-Delay Settlements ................................. 71 e. Mylan Unlawfully Exercised Its Monopoly Power to Force American Consumers--and Only American Consumers--to Purchase EpiPens in Pairs........................................................................................................... 90 2. Mylan's Relentless EpiPen Price Increases .............................................. 98 3. Comparison to Prices and Markets for Epinephrine Auto-Injectors in Europe ..................................................................................................... 107 4. False Statements Regarding Coupons, Rebates, and the Generic EpiPen ................................................................................................................. 109 5. False Statements to Congress Under Oath on September 21, 2016........ 112 F. Relevant Market and Mylan's Market Power ..................................................... 121

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G. Barriers to Entry.................................................................................................. 124 H. Tying the EpiPen 2-Pak ...................................................................................... 129 I. Antitrust Injury and Harm to Plaintiffs and Competition ................................... 130 J. Effect on Interstate and Intrastate Commerce..................................................... 131 K. Equitable Tolling, Discovery Rule, and Fraudulent Concealment ..................... 132 CLASS ACTION ALLEGATIONS ......................................................................................... 135 CLAIMS FOR RELIEF ............................................................................................................ 139 COUNT I Violation of Sections 1 & 2 of the Sherman Act Against All Defendants .... 139 COUNT II Violation of Section 3 of the Clayton Act Against All Defendants ............. 141 COUNT III Violation of State Antitrust Statutes: Conspiracy ....................................... 142 COUNT IV Violation of State Antitrust Statutes: Monopolization............................... 147 COUNT V Violation of State Antitrust Statutes: Attempted Monopolization .............. 150 COUNT VI Violation of State Antitrust Statutes: Tying............................................... 154 COUNT VII Violation of The Racketeer Influenced And Corrupt Organizations Act, 18 U.S.C. ? 1962.................................................................................................................. 159

A. The EpiPen Pricing Enterprise............................................................................ 160 1. The Mylan Defendants............................................................................ 161 2. The Pfizer Defendants............................................................................. 165 3. The PBM Conspirators ........................................................................... 166

B. The EpiPen Pricing Enterprise Sought to Illegally Dominate the Market and to Increase Profits and Revenues By Forcing Consumers to Purchase the EpiPen at an Inflated Price and, Since 2011, in a 2-Pak ..................................................... 168

C. The Pattern of Racketeering: Mail Fraud, Wire Fraud, and Corruption of an Official Proceeding ............................................................................................. 170 1. The RICO Defendants' Engaged in Predicate Acts to Defraud Consumers and Third-Party Payors and Exclude Competitors from the Market ...... 171 2. Agreements Between the RICO Defendants and the PBM Conspirators Served to Formalize the RICO Defendants' Fraudulent and AntiCompetitive Market Behavior................................................................. 176 3. The 2-Pak Arrival on the Market in 2011 Benefited the RICO Defendants Page 3

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and Illustrates a Piece of the EpiPen Pricing Enterprise......................... 177

4. The RICO Defendants' and PBM Conspirators' Pattern of Racketeering ................................................................................................................. 179

D. Causation and Damages ...................................................................................... 181 COUNT VIII Violation of State Consumer Protection Laws ......................................... 181

A. Violations Of The Alabama Deceptive Trade Practices Act ......................... 186 B. Violations Of The Arizona Consumer Fraud Act .......................................... 189 C. Violations of The Arkansas Deceptive Trade Practice Act............................ 194 D. Violation of California Consumers Legal Remedies Act .............................. 198 E. Violations of California False Advertising Law ............................................ 204 F. Violations of The California Unfair Competition Law .................................. 206 G. Violations of The Colorado Consumer Protection Act .................................. 212 H. Violations of Connecticut Unlawful Trade Practices Act.............................. 216 I. Violations of The Delaware Consumer Fraud Act .......................................... 221 J. Violations of Florida's Unfair & Deceptive Trade Practices Act ................... 225 K. Violations of Georgia's Fair Business Practices Act ..................................... 229 L. Violations of Georgia's Uniform Deceptive Trade Practices Act .................. 233 M. Unfair and Deceptive Acts In Violation of Hawaii Law ............................... 237 N. Violations of The Idaho Consumer Protection Act........................................ 241 O. Violations of Illinois Consumer Fraud And Deceptive Business Practices Act ............................................................................................................................. 246 P. Violations of The Indiana Deceptive Consumer Sales Act ............................ 250 Q. Violations of The Kansas Consumer Protection Act ..................................... 255 R. Violations of The Kentucky Consumer Protection Act ................................. 260 S. Violations of The Louisiana Unfair Trade Practices And Consumer Protection Law ..................................................................................................................... 263 T. Maine Unfair Trade Practices Act (MUTPA) and Uniform Deceptive Trade Practices Act (MUDTPA)................................................................................... 266 U. Violations of The Maryland Consumer Protection Act ................................. 271 V. Deceptive Acts or Practices Prohibited By Massachusetts Law.................... 275 W. Violations of The Michigan Consumer Protection Act................................. 280 Y. Violations of Minnesota Uniform Deceptive Trade Practices Act ................ 289 Z. Violations of Mississippi Consumer Protection Act ...................................... 293

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