throbber
Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 1 of 54 PageID: 1401
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IN THE DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`Case No. 3:20-cv-3426-BRM-LHG
`
`
`Document Filed Electronically
`
`ORAL ARGUMENT REQUESTED
`
`Motion return date: May 3, 2021
`
`
`IN RE: DIRECT PURCHASER
`INSULIN PRICING LITIGATION
`
`
`
`
`
`
`
`
`
`
`
`PHARMACY BENEFIT MANAGER DEFENDANTS’ BRIEF
`SUPPORTING THEIR RULE 12(b)(6) MOTIONS TO DISMISS THE
`FIRST AMENDED CLASS ACTION COMPLAINT
`
`
`
`
`
`
`
`
`(Counsel Listed on Next Page)
`
`
`
`
`
`
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 2 of 54 PageID: 1402
`
`
`
`Thomas P. Scrivo
`O’TOOLE SCRIVO, LLC
`14 Village Park Road
`Cedar Grove, NJ 07009
`T: (973) 239-5700
`tscrivo@oslaw.com
`
`Brian D. Boone (pro hac vice)
`ALSTON & BIRD LLP
`101 S. Tyron St., Ste. 4000
`Charlotte, NC 28280
`T: (704) 444-1000
`brian.boone@alston.com
`
`John M. Snyder (pro hac vice)
`ALSTON & BIRD LLP
`950 F. Street, NW
`Washington, D.C. 20004
`T: (202) 239-3300
`john.snyder@alston.com
`
`D. Andrew Hatchett (pro hac vice)
`ALSTON & BIRD LLP
`1201 W. Peachtree St. NW, Ste. 4900
`Atlanta, GA 30309
`T: (404) 881-7000
`andrew.hatchett@alston.com
`
`Attorneys for Defendants OptumRx, Inc., Optum, Inc., OptumRx Holdings, LLC,
`United Healthcare Services, Inc., and UnitedHealth Group
`
`
`Enu A. Mainigi (pro hac vice)
`Daniel M. Dockery (pro hac vice)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, D.C. 20005
`T: (202) 434-5000
`F: (202) 434-5029
`emainigi@wc.com
`ddockery@wc.com
`
`
`Kevin H. Marino
`John D. Tortorella
`MARINO, TORTORELLA &
`BOYLE, P.C.
`437 Southern Boulevard
`Chatham, New Jersey 07928
`T: (973) 824-9300
`F: (973) 824-8425
`kmarino@khmarino.com
`jtortorella@khmarino.com
`
`
`
`Attorneys for Defendants CVS Health Corporation, CaremarkPCS Health LLC,
`Caremark LLC, and Caremark RX LLC
`
`
`ii
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 3 of 54 PageID: 1403
`
`
`
`
`Drew Cleary Jordan
`MORGAN, LEWIS & BOCKIUS
`LLP
`502 Carnegie Center
`Princeton, NJ 08540-6289
`T: (202) 739-5962
`F: (609) 919-6701
`drew.jordan@morganlewis.com
`
`
`Jason R. Scherr (pro hac vice)
`Patrick A. Harvey (pro hac vice)
`MORGAN, LEWIS & BOCKIUS
`LLP
`1111 Pennsylvania Avenue, NW
`Washington, DC 20004
`T: 202.739.3000
`F: 202.739.3001
`jr.scherr@morganlewis.com
`patrick.harvey@morganlewis.com
`
`Attorneys for Defendants Express Scripts Holding Company, Express Scripts
`Inc., and Medco Health Solutions, Inc.
`
`
`iii
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 4 of 54 PageID: 1404
`
`
`
`B.
`
`C.
`
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION ..................................................................................................... 1
`BACKGROUND ....................................................................................................... 2
`LEGAL STANDARD ................................................................................................ 4
`ARGUMENT ............................................................................................................. 5
`I.
`THE ANTITRUST CLAIMS AGAINST THE PBMS FAIL RULE
`8’S PLAUSIBILITY STANDARD. ................................................................ 5
`A.
`Plaintiffs do not allege that the PBMs participated in a
`horizontal price-fixing conspiracy. ....................................................... 6
`Plaintiffs fail to allege anticompetitive vertical agreements
`plausibly violating the rule of reason. ................................................... 7
`Plaintiffs fail to plausibly allege that the PBMs joined an
`“overarching conspiracy” to fix WAC prices. ...................................... 8
`THE ROBINSON-PATMAN ACT CLAIM FAILS ON ITS FACE. ..........12
`A.
`The Robison-Patman Act claims fail because Plaintiffs do not
`allege a buyer-seller relationship, a fiduciary duty, or sham
`payments. .............................................................................................12
`Plaintiffs lack standing to assert a claim under Section 2(c). .............14
`B.
`III. THE RICO CLAIMS FAIL THE APPLICABLE PLEADING
`STANDARDS. ..............................................................................................15
`A.
`Plaintiffs fail to allege predicate acts of racketeering. ........................16
`1.
`The Anti-Kickback Statute is not a RICO predicate. ...............17
`2.
`A rebate-based AKS violation does not violate the Travel
`Act. ............................................................................................17
`Even if the AKS could serve as a RICO predicate,
`Plaintiffs do not allege an AKS violation. ................................19
`
`3.
`
`iv
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 5 of 54 PageID: 1405
`
`
`
`4.
`
`2.
`
`B.
`
`C.
`
`D.
`
`Plaintiffs fail to allege mail and wire fraud with
`particularity. ..............................................................................22
`Plaintiffs fail to allege proximate causation or injury. ........................27
`1.
`Plaintiff wholesalers were not directly injured by an
`alleged RICO scheme premised on the AKS or mail or
`wire fraud. .................................................................................27
`Plaintiffs’ failure to allege reliance also defeats their
`RICO claims predicated on mail and wire fraud. .....................30
`Plaintiffs fail to allege any concrete financial injury. ...............32
`3.
`Plaintiffs fail to plausibly allege that each PBM operated and
`managed a RICO enterprise’s affairs rather than its own affairs. .......33
`Plaintiffs fail to allege the existence of a RICO enterprise
`distinct from the alleged racketeering. ................................................38
`IV. PLAINTIFFS FAIL TO ALLEGE A RICO CONSPIRACY. ......................40
`CONCLUSION ........................................................................................................40
`
`
`
`
`
`v
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 6 of 54 PageID: 1406
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`CASES
`2660 Woodley Road Joint Venture v. ITT Sheraton Corp.,
`369 F.3d 732 (3d Cir. 2004) ................................................................... 12, 14, 15
`Annulli v. Panikkar,
`200 F.3d 189 (3d Cir. 1999) ............................................................................... 17
`Anza v. Ideal Steel Supply Corp.,
`547 U.S. 451 (2006) ................................................................................ 16, 27, 29
`Arthur v. Guerdon Indus.,
`827 F. Supp. 273 (D. Del. 1993) ......................................................................... 32
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) .............................................................................................. 4
`Baar v. Jaguar Land Rover N. Am., LLC,
`295 F. Supp. 3d 460 (D.N.J. 2018) ....................................................................... 7
`Baglio v. Baska,
`940 F. Supp. 819 (W.D. Pa. 1996) ...................................................................... 28
`Barton & Pittinos, Inc. v. SmithKline Beecham Corp.,
`118 F.3d 178 (3d Cir. 1997) ............................................................................... 15
`Beck v. Prupis,
`529 U.S. 494 (2000) ...................................................................................... 16, 17
`Bell Atl. Corp. v. Twombly,
`550 U.S. 544 (2007) .....................................................................................passim
`Bible v. United Student Aid Funds, Inc.,
`799 F.3d 633 (7th Cir. 2015) .............................................................................. 36
`Bonilla v. Volvo Car Corp.,
`150 F.3d 62 (1st Cir. 1998) ................................................................................. 26
`Bowen v. Georgetown Univ. Hosp.,
`488 U.S. 204 (1988) ............................................................................................ 22
`
`vi
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 7 of 54 PageID: 1407
`
`
`
`Bridges v. MacLean-Stevens Studios, Inc.,
`201 F.3d 6 (1st Cir. 2000) ................................................................................... 13
`Brittingham v. Mobil Corp.,
`943 F.2d 297 (3d Cir. 1991) ............................................................................... 37
`Burtch v. Milberg Factors, Inc.,
`662 F.3d 212 (3d Cir. 2011) ................................................................................. 5
`Bus. Elecs. Corp v. Sharp Elecs. Corp.,
`485 U.S. 717 (1988) .............................................................................................. 6
`City of Rockford v. Mallinckrodt ARD, Inc.,
`360 F. Supp. 3d 730 (N.D. Ill. 2019) .................................................................. 26
`Coleman v. Commonwealth Land Title Ins. Co.,
`318 F.R.D. 275 (E.D. Pa. 2016) .......................................................................... 31
`Crest Constr. II, Inc. v. Doe,
`660 F.3d 346 (8th Cir. 2011) .............................................................................. 39
`CZ Servs., Inc. v. Express Scripts Holding Co.,
`2020 WL 4368212 (N.D. Cal. July 30, 2020) .................................................... 14
`Devon Drive Lionville, LP v. Parke Bancorp, Inc.,
`2018 U.S. Dist. LEXIS 125011 (E.D. Pa. July 26, 2018) .................................. 31
`Devon Drive Lionville, LP v. Parke Bancorp, Inc.,
`791 F. App’x 301 (3d Cir. 2019) ............................................................ 29, 30, 31
`Dist. 1199P Health & Welfare Plan v. Janssen, L.P.,
`784 F. Supp. 2d 508 (D.N.J. 2011) ............................................................... 31, 32
`Eller v. EquiTrust Life Ins. Co.,
`778 F.3d 1089 (9th Cir. 2015) ............................................................................ 26
`Elliott v. Foufas,
`867 F.2d 877 (5th Cir. 1989) .............................................................................. 16
`Env’t. Tectonics v. W.S. Kirkpatrick, Inc.,
`847 F.2d 1052 (3d Cir. 1988) ............................................................................. 13
`
`vii
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 8 of 54 PageID: 1408
`
`
`
`Gross v. Waywell,
`628 F. Supp. 2d 475 (S.D.N.Y. 2009) ................................................................ 15
`H. J., Inc. v. Nw. Bell Tel. Co.,
`492 U.S. 229 (1989) ............................................................................................ 27
`Hamm v. Rhone-Poulenc Rorer Pharms.,
`187 F.3d 941 (8th Cir. 1999) .............................................................................. 30
`Hemi Grp., LLC v. City of New York,
`559 U.S. 1 (2010) ................................................................................................ 27
`Holmes v. Secs. Inv. Prot. Corp.,
`503 U.S. 258 (1992) ............................................................................................ 27
`Humphrey v. GlaxoSmithKline PLC,
`905 F.3d 694 (3d Cir. 2018) ............................................................................... 38
`Ill. Farmers Ins. Co. v. Mobile Diagnostic Imaging, Inc.,
`2014 WL 4104789 (D. Minn. Aug. 19, 2014) .............................................. 17, 39
`In re Aetna UCR Litig.,
`2015 U.S. Dist. LEXIS 84600 (D.N.J. June 30, 2015) ....................................... 37
`In re EpiPen ERISA Litig.,
`2020 U.S. Dist. LEXIS 139066 (D. Minn. Aug. 5, 2020) .................................. 10
`In re Express Scripts, Inc., PBM Litig.,
`2008 WL 2952787 (E.D. Mo. July 30, 2008) ............................................... 14, 42
`In re Ins. Brokerage Antitrust Litig.,
`618 F.3d 300 (3d Cir. 2010) ................................................................................. 9
`In re Insulin Pricing Litig.,
`2019 U.S. Dist. LEXIS 25185 (D.N.J. Feb. 15, 2019) ..................... 24, 25, 37, 38
`In re Insulin Pricing Litig.,
`No. 3:17-cv-00699 (D.N.J. Mar. 29, 2018), ECF No. 131 ................................. 38
`In re Intuniv Antitrust Litig.,
`2019 WL 4645502 (D. Mass. Sept. 24, 2019) .................................................... 16
`
`viii
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 9 of 54 PageID: 1409
`
`
`
`In re Processed Egg Prods. Antitrust Litig.,
`821 F. Supp. 2d 709 (E.D. Pa. 2011) .................................................................... 7
`InterVest, Inc. v. Bloomberg, L.P.,
`340 F.3d 144 (3d Cir. 2003) ............................................................................... 11
`Kolar v. Preferred Real Estate Invs., Inc.,
`361 F. App’x 354 (3d Cir. 2010) ........................................................................ 27
`Langford v. Rite Aid of Ala., Inc.,
`231 F.3d 1308 (11th Cir. 2000) .......................................................................... 26
`Leegin Creative Leather Prods. v. PSKS, Inc.,
`551 U.S. 877 (2007) .............................................................................................. 7
`Lightning Lube v. Witco Corp.,
`4 F.3d 1153 (3d Cir. 1993) ................................................................................. 40
`Lum v. Bank of Am.,
`361 F.3d 217 (3d Cir. 2004) ............................................................... 4, 16, 22, 23
`Lupian v. Joseph Cory Holdings LLC,
`905 F.3d 127 (3d Cir. 2018) ............................................................................... 22
`Malvino v. Delluniversita,
`840 F.3d 223 (5th Cir. 2016) .............................................................................. 26
`McCullough v. Zimmer, Inc.,
`2009 WL 775402 (W.D. Pa. Mar. 18, 2009) ...................................................... 36
`Menzies v. Seyfarth Shaw LLP,
`943 F.3d 328 (7th Cir. 2019) .............................................................................. 27
`N.V.E., Inc. v. Palmeroni,
`2015 U.S. Dist. LEXIS 192712 (D.N.J. Feb. 23, 2015) ............................... 34, 40
`Naporano Iron & Metal Co. v. Am. Crane Corp.,
`79 F. Supp. 2d 494 (D.N.J. 1999) ....................................................................... 23
`Nelson v. Nelson,
`833 F.3d 965 (8th Cir. 2016) .............................................................................. 38
`
`ix
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 10 of 54 PageID: 1410
`
`
`
`Reves v. Ernst & Young,
`507 U.S. 170 (1993) ............................................................................................ 33
`Rolo v. City Investing Co. Liquidating Tr.,
`155 F.3d 644 (3d Cir. 1998) ............................................................................... 24
`Russello v. United States,
`464 U.S. 16 (1983) .............................................................................................. 26
`Santomenno ex rel. John Hancock Tr. v. John Hancock Life Ins. Co.,
`768 F.3d 284 (3d Cir. 2014) ............................................................................... 22
`Santos v. Beeler,
`40 F. Supp. 2d 566 (D.N.J. 1999) ....................................................................... 22
`Seaboard Supply Co. v. Congoleum Corp.,
`770 F.2d 367 (3d Cir. 1985) ......................................................................... 12, 13
`Shaw v. Nissan N. Am., Inc.,
`220 F. Supp. 3d 1046 (C.D. Cal. 2016) .............................................................. 36
`Silverstein v. Percudani,
`422 F. Supp. 2d 468 (M.D. Pa. 2006) ................................................................. 23
`Smith v. Jones, Gregg, Creehan & Gerace LLP,
`2008 WL 5129916 (W.D. Pa. Dec. 5, 2008) ...................................................... 33
`Stephens, Inc. v. Geldermann, Inc.,
`962 F.2d 808 (8th Cir. 1992) ........................................................................ 39, 40
`Total Benefits Planning Agency, Inc. v. Anthem Blue Cross & Blue
`Shield,
`552 F.3d 430 (6th Cir. 2008) ................................................................................ 6
`
`United Ass’n of Plumbers & Pipefitters Local 322 of S. N.J. v.
`Mallinckrodt ARD, LLC.,
`2020 U.S. Dist. LEXIS 148343 (D.N.J. Aug. 18, 2020) .................................... 26
`
`United Food & Com. Worker Unions & Emps. Midwest Health
`Benefits Fund v. Walgreen Co.,
`719 F.3d 849 (7th Cir. 2013) ............................................................ 33, 35, 36, 37
`
`x
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 11 of 54 PageID: 1411
`
`
`
`United States ex rel. Arnstein v. Teva Pharms. USA, Inc.,
`2019 WL 1245656 (S.D.N.Y. Feb. 27, 2019) .................................................... 28
`United States ex rel. Fox Rx, Inc. v. Dr. Reddy’s Inc.,
`2014 WL 6750786 (S.D.N.Y. Dec. 1, 2014) ...................................................... 20
`United States v. Turkette,
`452 U.S. 576 (1981) ............................................................................................ 39
`Young v. E. Tex. Med. Ctr. Reg’l Healthcare Sys.,
`2017 U.S. Dist. LEXIS 218257 (N.D. Okla. Nov. 6, 2017) ............................... 17
`RULES
`Fed. R. Civ. P. 8 ..................................................................................................... 4, 5
`Fed. R. Civ. P. 9(b) ........................................................................................ 4, 22, 24
`Fed. R. Civ. P. 12(b)(6) ............................................................................................ 22
`STATUTES
`15 U.S.C. § 13(c) ................................................................................... 12, 13, 14, 15
`18 U.S.C. § 1952(b) ................................................................................................. 18
`18 U.S.C. §1961(1) ............................................................................................ 16, 17
`18 U.S.C. § 1962(c) ................................................................................. 5, 32, 37, 40
`18 U.S.C. § 1962(d) ............................................................................................. 5, 40
`18 U.S.C. §1964(c) .................................................................................................. 27
`42 U.S.C. §1320a-7b ..................................................................................... 17, 18 19
`42 U.S.C. § 1395w-3a(c)(6)(B) ............................................................................... 25
`PHILLIP E. AREEDA & HERBERT HOVENKAMP, ANTITRUST LAW ............................... 6
`OTHER AUTHORITIES
`42 C.F.R. §1001.952(h)(5) ....................................................................................... 20
`42 C.F.R. §1001.952(j) ............................................................................................ 20
`
`xi
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 12 of 54 PageID: 1412
`
`
`
`42 CFR § 1001.952(h)(3) ......................................................................................... 18
`42 CFR § 1001.952(h)(4) ......................................................................................... 18
`84 Fed. Reg. 2340 (Feb. 6, 2019) ............................................................................ 21
`85 Fed. Reg. 76666 (Nov. 30, 2020)........................................................................ 21
`CBO’s Budget Projections, CONGRESSIONAL BUDGET OFFICE (May
`2019) ................................................................................................................... 21
`Exec. Order No. 13939, Lowering Prices for Patients by Eliminating
`Kickbacks to Middlemen,
`85 Fed. Reg. 45759, 45759 (July 24, 2020) ....................................................... 21
`Medicare and State Health Care Programs: Fraud and Abuse,
`64 Fed. Reg. 63518, 63518 (Nov. 19, 1999) ...................................................... 20
`OIRA Conclusion of EO 12866 Regulatory Review: Removal of Safe
`Harbor Protection for Rebates to Plans or PBMs Involving
`Prescription Pharmaceuticals and Creation of New Safe Harbor
`Protection, Office of Info. & Reg. Affs. (July 10, 2019) ................................... 21
`OIG Compliance Program Guidance for Pharmaceutical
`Manufacturers,
`68 Fed. Reg. 23731, 23734, 23736 (May 5, 2003) ............................................. 20
`The Prescription Drug Landscape Explored - A look at retail
`pharmaceutical spending from 2012 to 2016 THE PEW
`CHARITABLE TRS. (Mar. 2019) ........................................................................... 11
`
`
`
`xii
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 13 of 54 PageID: 1413
`
`
`
`INTRODUCTION
`Plaintiffs Professional Drug Company and Frank W. Kerr Holdings make the
`
`sweeping allegation that three drug manufacturers and three pharmacy benefit
`
`managers (PBMs) engaged in an industry-wide, “overarching conspiracy” to inflate
`
`insulin prices. This is not a typical conspiracy case; Plaintiffs ask this Court to hold
`
`that the normal operation of the country’s pharmaceutical reimbursement system—
`
`including
`
`the PBMs’
`
`respective arm’s-length
`
`rebate negotiations with
`
`manufacturers—constitutes racketeering and violates the antitrust laws. Whatever
`
`one’s policy views about the most effective way to lower drug costs, the
`
`pharmaceutical-rebate system is neither criminal nor illegal.
`
`Plaintiffs are not the first to sue over insulin prices. This Court has considered
`
`variants of a supposed insulin “scheme” three times before. But those earlier cases
`
`were exclusively against the insulin manufacturers who set the list price—not PBMs.
`
`And although some factual allegations here resemble those earlier cases, Plaintiffs
`
`press claims never litigated before this Court—including under the Robinson-
`
`Patman Act and the Sherman Act—and allege different RICO predicates not raised
`
`in other cases. Plaintiffs do so because, as wholesalers that resell insulin at a markup,
`
`they cannot fit their claims in traditional boxes. All of Plaintiffs’ claims fail the
`
`applicable pleading standards, and in many instances, Plaintiffs’ own allegations
`
`betray them.
`
`1
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 14 of 54 PageID: 1414
`
`
`
`BACKGROUND
`Plaintiff Professional Drug Company is a drug wholesaler who purchased
`
`certain insulin products in 2010 and earlier. Compl. ¶¶ 14, 15. Plaintiff Frank W.
`
`Kerr Holdings is a shell company that acquired antitrust claims from a defunct drug
`
`wholesaler that went bankrupt in 2016. Id. ¶¶ 12, 55. Drug wholesalers like Plaintiffs
`
`purchase pharmaceutical products from manufacturers and then resell them at a
`
`mark-up to pharmacies, which then dispense the products to patients. Id. ¶ 57.
`
`PBMs are not in the same business as drug wholesalers (or manufacturers).
`
`Id. ¶ 60. Instead, PBMs contract with health plans and third-party payors (the PBMs’
`
`clients) to administer their clients’ prescription-drug benefits. Id. In that role, PBMs
`
`develop formularies (lists of approved drugs) that their clients may adopt or
`
`customize when designing their prescription benefits and plan coverage. Id. ¶¶ 68–
`
`71. PBMs also negotiate rebates with drug manufacturers to lower their clients’ net
`
`drug costs. Id. ¶ 61.
`
`The PBMs’ role in formulary development “forces drug companies to engage
`
`in price negotiation.” Id. ¶ 61. In contrast to “open” formularies that included
`
`“virtually all available FDA-approved drugs,” PBMs in recent years allegedly
`
`switched to “closed” formularies enabling them to exclude a given drug if its
`
`manufacturer refuses to offer favorable pricing. Id. ¶¶ 73–80. Drug manufacturers
`
`fear exclusion because “if a drug is excluded, it can dramatically hobble sales.” Id.
`
`2
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 15 of 54 PageID: 1415
`
`
`
`¶ 76. Plaintiffs allege that PBMs “pit[] [drug companies] against each other” and
`
`“will move market share” to the companies that offer “the best price.” Id. ¶ 78.
`
`At issue here is a subset of insulin products: Novo Nordisk’s NovoLog and
`
`Levemir, Eli Lilly’s Humalog, and Sanofi’s Lantus. Id. ¶ 2. Plaintiff Professional
`
`Drug Company did not purchase any of those products during the relevant period.1
`
`Plaintiffs allege that beginning in 2012, the Insulin Manufacturers increased
`
`the price of Insulin Drugs in lockstep (id. ¶ 120) as part of a price-fixing conspiracy.
`
`Id. ¶ 149. Plaintiffs never explain what role, if any, the PBMs played in that alleged
`
`conspiracy. They do not allege that the PBMs controlled, knew about, or had input
`
`into the Manufacturers’ list prices (the wholesale acquisition cost or “WAC”).
`
`Instead, Plaintiffs allege that the Manufacturers—acting independently—increased
`
`their list prices in response to, not in concert with, the PBMs’ negotiations for
`
`increased rebates. Id. ¶¶ 101–03. Although Plaintiffs allege that the PBMs benefited
`
`from higher WAC prices because manufacturers pay rebates as a percentage of WAC
`
`(id. ¶ 93), they do not allege that the Manufacturers increased WAC prices at the
`
`PBMs’ direction, nor could they.
`
`
`1 Professional Drug Company alleges that it purchased only Levemir and Lantus but
`does not say when those purchases occurred. Compl. ¶15. In a prior complaint that
`PDC voluntarily dismissed, PDC alleged making only three relevant purchases, the
`last in 2010. See Complaint, Pro. Drug Co. v. Sanofi-Aventis U.S. LLC, No. 3:19-
`cv-18326 (D.N.J. Sept. 25, 2019), ECF No. 1, at ¶¶ 2, 51, 364. Accordingly, PDC’s
`last relevant purchase was two years before the alleged price inflation began. Its
`claims should be dismissed for lack of standing. See Mfr. Br. at 39–40.
`
`3
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 16 of 54 PageID: 1416
`
`
`
`
`
`LEGAL STANDARD
`To survive a motion to dismiss, “a complaint must contain sufficient factual
`
`matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’”
`
`Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550
`
`U.S. 544, 570 (2007)). “Threadbare recitals of the elements of a cause of action,
`
`supported by mere conclusory statements, do not suffice.” Iqbal, 556 U.S. at 678. In
`
`a case alleging conspiracy, the “need at the pleading stage for allegations plausibly
`
`suggesting (not merely consistent with) agreement reflects the threshold requirement
`
`of Rule 8(a)(2) that the ‘plain statement’ possess enough heft ‘to sho[w] that the
`
`pleader is entitled to relief.’” Twombly, 550 U.S. at 557 (quoting Rule 8).
`
`
`
`Plaintiffs’ fraud claims must also satisfy Rule 9(b), which requires “plead[ing]
`
`with particularity the circumstances of the alleged fraud in order to place the
`
`defendants on notice of the precise misconduct with which they are charged, and to
`
`safeguard defendants against spurious charges of immoral and fraudulent behavior.”
`
`Lum v. Bank of Am., 361 F.3d 217, 223–24 (3d Cir. 2004) (internal quotations
`
`omitted). To satisfy Rule 9(b), a plaintiff must allege facts describing “the ‘date,
`
`place or time’ of the fraud,” or otherwise offer enough facts to “inject[] precision
`
`and some measure of substantiation into their allegations of fraud.” Id. They “also
`
`must allege who made a misrepresentation to whom and the general content of the
`
`misrepresentation.” Id. at 224.
`
`4
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 17 of 54 PageID: 1417
`
`
`
`I.
`
`ARGUMENT
`THE ANTITRUST CLAIMS AGAINST THE PBMS FAIL RULE 8’S
`PLAUSIBILITY STANDARD.
`Plaintiffs’ central Sherman Act claim—captioned “Violation of the Sherman
`
`Act”—is directed solely against the Manufacturers (Count Two). As to the PBMs,
`
`Plaintiffs attempt to repackage those allegations as a “Conspiracy to Violate the
`
`Sherman Act” (Count Three). Plaintiffs do not advance a clear legal theory against
`
`the PBMs,2 but whatever their theory, it does not work.
`
`A plaintiff suing under Section 1 must plead, among other things, that “(1) the
`
`defendant was a party to a contract, combination . . . or conspiracy” and “(2) the
`
`conspiracy to which the defendant was a party imposed an unreasonable restraint on
`
`trade.” Burtch v. Milberg Factors, Inc., 662 F.3d 212, 221–22 (3d Cir. 2011).
`
`Plaintiffs don’t satisfy those requirements against the PBMs.
`
`Plaintiffs allege that the PBMs joined some ill-defined “overarching
`
`conspiracy to artificially fix, raise, maintain and/or stabilize the prices of the Insulin
`
`Drugs.” Compl. ¶ 212. But the nine pages in the Complaint devoted to the price-
`
`fixing claims barely mention the PBMs—leaving them to guess about their role in
`
`
`2 Unlike RICO, which includes both a substantive violation and a separate claim for
`conspiracy (see 18 U.S.C. § 1962(c), (d)), there is no separate claim for “conspiracy”
`to violate Section 1. Because Section 1 is itself a conspiracy claim, Plaintiffs’ claim
`for “Conspiracy to Violate the Sherman Act” is effectively a claim for conspiracy to
`conspire. It makes no sense.
`
`5
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 18 of 54 PageID: 1418
`
`
`
`the “conspiracy.” See Compl. ¶¶120–42. After Twombly (550 U.S. at 557) that sort
`
`of threadbare pleading does not suffice. See Total Benefits Planning Agency, Inc. v.
`
`Anthem Blue Cross & Blue Shield, 552 F.3d 430, 436 (6th Cir. 2008) (“Generic
`
`pleading, alleging misconduct against defendants without specifics as to the role
`
`each played in the alleged conspiracy, was specifically rejected by Twombly.”).
`
`In any antitrust case, courts must ensure that a plaintiff alleges “who was in
`
`agreement with whom” and “about what” before “mov[ing] on to look for the
`
`necessary agreement.” PHILLIP E. AREEDA & HERBERT HOVENKAMP, ANTITRUST
`
`LAW: AN ANALYSIS OF ANTITRUST PRINCIPLES AND THEIR APPLICATION (5th ed.
`
`2020), at ¶ 1409 (hereinafter, “Hovenkamp”). The complaint fails to answer those
`
`basic questions. As to the PBMs, Plaintiffs do not even allege whether the
`
`supposedly unlawful agreements fall into recognized horizontal or vertical
`
`categories. Whether viewed as an alleged horizontal or vertical conspiracy or a
`
`nebulous and far-fetched “overarching” conspiracy, Plaintiffs’ claims fall short.
`
`A.
`
`Plaintiffs do not allege that the PBMs participated in a horizontal
`price-fixing conspiracy.
`A horizontal agreement is an agreement between competitors at the same level
`
`
`
`of the distribution chain. Bus. Elecs. Corp v. Sharp Elecs. Corp., 485 U.S. 717, 730
`
`(1988). PBMs and Manufacturers do not compete with each other because PBMs do
`
`not make or sell insulin. See Compl. ¶¶ 56, 60. Manufacturers and PBMs thus cannot
`
`horizontally conspire with each other.
`
`6
`
`

`

`Case 3:20-cv-03426-BRM-LHG Document 131-1 Filed 01/13/21 Page 19 of 54 PageID: 1419
`
`
`
`
`
`And Plaintiffs do not even attempt to allege a horizontal price-fixing
`
`conspiracy among the PBMs. At most, Plaintiffs allege that PBMs were “members
`
`of trade associations” like the Pharmaceutical Care Management Association
`
`(PCMA) and that they attended multiple PCMA conferences. Compl. ¶¶ 130–33.
`
`But participating in those types of routine business activities is, without more,
`
`presumptively legitimate. In re Processed Egg Prods. Antitrust Litig., 821 F. Supp.
`
`2d 709, 722 (E.D. Pa. 2011), aff’d, 962 F.3d 719 (3d Cir. 2020) (“[L]egal authority
`
`is clear that participation in a trade group association and/or attending trade group
`
`meetings, even those meetings where key facets of the conspiracy allegedly were
`
`adopted or advanced, are not enough on their own to give rise to the inference of
`
`agreement to the conspiracy.”).
`
`B.
`
`Plaintiffs fail to allege anticompetitive vertical agreements
`plausibly violating the rule of reason.
`If, instead, Plaintiffs’ Section 1 theory is predicated on a vertical agreement
`
`between each PBM and each Manufacturer, that theory also fails. Vertical
`
`arrangements are analyzed under the rule of reason, not the per se rule. Leegin
`
`Creative Leather Prods. v. PSKS, Inc., 551 U.S. 877, 898 (2007). Plaintiffs do not
`
`allege any of the facts necessary to establish an unlawful vertical arrangement under
`
`the rule of reason. See, e.g., Baar v. Jaguar Land Rover N. Am., LLC, 295 F. Supp.
`
`3d 460, 464 (D.N.J. 2018) (claims analyzed under the rule of reason require factual
`
`allegations supporting all four elements of a Section 1 claim, including “concerted
`
`7
`
`

`

`Case

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket