FWK Holdings LLC v. Shire PLC (Direct Purchaser Antitrust Class Action Complaint)

District Court, D. Massachusetts·Decided July 24, 2020·No. 1:16-cv-12653·Unknown

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

* * * * In re INTUNIV ANTITRUST LITIGATION * Civil Action No. 1:16-cv-12653-ADB (Direct Purchasers) * * * *

MEMORANDUM AND ORDER ON MEIJER’S MOTION TO INTERVENE

BURROUGHS, D.J. On July 8, 2020, the Court found that Rochester Drug Co-Operative Inc. (“RDC”) could no longer adequately represent a class of Direct-Purchaser Plaintiffs (the “DPPs”). [ECF No. 456]. Perhaps anticipating the need for a new class representative, Meijer, Inc. and Meijer Distribution, Inc. (collectively “Meijer”), members of the DPP class, moved to intervene under Rule 24 of the Federal Rules of Civil Procedure before the Court issued its order. [ECF No. 439]. For the reasons explained herein, the motion to intervene, [ECF No. 439], is GRANTED. I. BACKGROUND A. The Case Thus Far This case arises from an alleged anticompetitive agreement made between the brand and generic manufacturers of an ADHD medication. Defendants Shire LLC and Shire U.S., Inc. (collectively, “Shire”) manufacture Intuniv, the brand-name for extended release guanfacine hydrochloride. Defendants Actavis Elizabeth LLC, Actavis Holdco US, Inc., and Actavis LLC (collectively, “Actavis” and, together with Shire, “Defendants”) manufacture Intuniv’s generic counterpart. DPPs allege that they paid inflated prices for Intuniv due to Defendants’ having improperly agreeing to delay competition for both brand Intuniv and generic Intuniv in violation of Sections 1 and 2 of the Sherman Act, 15 U.S.C. §§ 1–2. See generally [ECF No. 140 (“Consolidated Amended Complaint” or “CAC”)]. For purposes of this motion, the following facts, as summarized from the Court’s previous order on the DPPs’ motion for class certification,

[ECF No. 343], will suffice. On September 2, 2009, the Food and Drug Administration (“FDA”) approved a New Drug Application (“NDA”) for Shire’s brand-name drug, Intuniv. [ECF No. 343 at 2]. A few months later, on December 29, 2009, Actavis filed an Abbreviated New Drug Application (“ANDA”) for its proposed generic version of Intuniv. [Id.]. Several other companies subsequently sought FDA approval to manufacture their own generic alternatives to Intuniv. [ECF No. 343 at 3]. As the first generic manufacturer to file an ANDA, Actavis would have enjoyed “a 180-day period of exclusivity during which no other generic” manufacturer could have manufactured an Intuniv alternative. In re Loestrin 24 Fe Antitrust Litig., 814 F.3d 538, 543 (1st Cir. 2016). During that exclusivity period, Shire and Actavis would have been the only

manufacturers approved by the FDA for Intuniv or a generic alternative. Shire filed suit against Actavis pursuant to 21 U.S.C. § 335(j)(5)(B)(iii), which triggered a 30-month stay of the FDA’s approval of Actavis’ ANDA for generic Intuniv. See F.T.C. v. Actavis, Inc., 570 U.S. 136, 143 (2013) (“If the brand-name patentee brings an infringement suit within 45 days, the FDA then must withhold approving the generic, usually for a 30-month period, while the parties litigate patent validity (or infringement) in court.” (citing 21 U.S.C. § 355(j)(5)(B)(iii))). After a bench trial, the 30-month stay of the FDA’s consideration of Actavis’ ANDA expired and the FDA approved generic Intuniv. [ECF No. 343 at 3]. Before the trial court could issue its opinion, however, Shire and Actavis entered into a settlement agreement. [Id.]. The DPPs argue that it appeared likely that the verdict was going to be in Actavis’ favor and that the settlement was a reverse payment agreement, which guaranteed Actavis a 180-day exclusivity period in return for its delaying the launch of generic Intuniv until

December 1, 2014. [Id.]. FWK Holdings, LLC (“FWK”) filed this action on December 30, 2016, [ECF No. 1], and RDC filed similar claims on January 11, 2017. The Court granted a joint motion to consolidate the two actions. [ECF No. 19]. The case has proceeded in coordination with claims originally brought on behalf of a putative class of indirect purchasers of Intuniv. See Picone v. Shire, LLC, No. 16-cv-12396 (D. Mass. June 8, 2020).1 On September 24, 2019, the Court granted the DPPs’ motion to certify the following class: All persons or entities in the United States and its territories, or subsets thereof, that purchased Intuniv and/or generic Intuniv in any form directly from Shire or Actavis, including any predecessor or successor of Shire or Actvais, from October 19, 2012 through June 1, 2015 (the “Class”).

[ECF No. 343 at 4, 23]. The Court, however, dismissed FWK as a class representative after finding that the relationship between FWK and class counsel was too entangled. [Id. at 16]. The Court had reservations about RDC’s adequacy as a class representative given that it had entered into a deferred prosecution agreement and settled civil claims with the United States in connection with failures to report suspicious opioid purchases, but ultimately agreed that it could serve as class representative. [Id. at 17–18]. As the case progressed, the parties filed a number

1 On August 21, 2019, the Court denied the indirect purchaser’s motion to certify two classes of indirect purchasers. [ECF No. 230]. The indirect purchasers filed a petition with the First Circuit to appeal the Court’s decision. The Court of Appeals has not yet ruled on the petition. See generally Picone, et al. v. Shire, No. 19-8023 (1st Cir. 2019). of evidentiary motions, as well as motions for summary judgment, which remain pending. [ECF Nos. 294, 295, 296, 297, 298, 299, 327, 329, 331, 333, 335, 337, 339, 341, 382, 412, 413, 416, 418]. On March 12, 2020, RDC filed for bankruptcy under Chapter 11 in the United States

Bankruptcy Court for the Western District of New York. See In re Rochester Drug Co- Operative, Inc., No. 20-cv-20230 (Bankr. W.D.N.Y.). Defendants moved to decertify the DPP class, in light of RDC’s bankruptcy. [ECF No. 404]. The Court granted the motion in part and found that RDC could no longer adequately represent the interests of absent class members due to a conflict of interests arising from its bankruptcy. [ECF No. 456]. The Court declined to decertify the class, however, and allowed motions to intervene. [Id. at 14–15]. Meijer is a pharmacy retailer headquartered in Michigan. As a member of the DPP class, it received notice of the class action on January 24, 2020. [ECF No. 440-1 ¶ 6]. Meijer claims to have “purchased many millions of dollars of brand and generic Intuniv throughout the class period.” [ECF No. 440 at 8; ECF No. 440-1 ¶ 5]. Additionally, it holds a long-standing

agreement for assignment of direct-purchaser claims for brand Intuniv from Frank W. Kerr Co. [ECF No. 440 at 8; ECF No. 440-1 ¶ 5]. Meijer has prepared a complaint in intervention, which is nearly identical to the second amended complaint, but adds Meijer as a class representative. [ECF No. 440-1 ¶ 9; ECF No. 440-3]. B. Procedural History Meijer filed its motion to intervene on June 2, 2020, [ECF No. 439], and Defendants opposed, [ECF No. 449]. On July 8, 2020, the Court found that RDC could no longer adequately represent the DPP class due to its bankruptcy and informed the parties that it would consider the pending motion to intervene. [ECF No. 456].

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