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

CourtDistrict Court, D. Massachusetts
DecidedJuly 8, 2020
Docket1:16-cv-12653
StatusUnknown

This text of FWK Holdings LLC v. Shire PLC (Direct Purchaser Antitrust Class Action Complaint) (FWK Holdings LLC v. Shire PLC (Direct Purchaser Antitrust Class Action Complaint)) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
FWK Holdings LLC v. Shire PLC (Direct Purchaser Antitrust Class Action Complaint), (D. Mass. 2020).

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 DEFENDANTS’ MOTION TO DECERTIFY THE CLASS

BURROUGHS, D.J. Direct-Purchaser Plaintiff Rochester Drug Co-Operative, Inc. (“RDC”) filed this antitrust action on behalf of a putative class comprised of entities that purchased the pharmaceutical Intuniv (the brand name for extended release guanfacine hydrochloride) from the drug’s brand manufacturer Shire LLC and Shire U.S., Inc. (collectively, “Shire”) or from the drug’s generic manufacturer Actavis Elizabeth LLC, Actavis Holdco US, Inc., and Actavis LLC (collectively, “Actavis” and, together with Shire, “Defendants”). The Direct-Purchaser Plaintiffs (“DPPs”) allege that Defendants improperly delayed 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, causing the DPPs to pay an inflated price for Intuniv. See generally [ECF No. 140 (“Consolidated Amended Complaint” or “CAC”)]. Presently before the Court is Defendants’ motion to decertify the DPP Class in light of RDC’s bankruptcy. [ECF No. 404]. For the reasons explained herein, the motion is GRANTED in part and DENIED in part. I. BACKGROUND The Court has previously discussed the facts that brought about this class-action antitrust action in its memorandum and order on Defendants’ motion to dismiss, [ECF No. 92-1], and its memorandum and order on the DPPs’ motion for class certification, [ECF No. 343]. For

purposes of considering Defendants’ motion to decertify the DPP Class, the Court provides the following limited background. On September 2, 2009, the Food and Drug Administration (“FDA”) approved a New Drug Application (“NDA”) for Defendant Shire’s ADHD medication Intuniv. [ECF No. 343 at 2]. On December 29, 2009, Defendant Actavis filed an Abbreviated New Drug Application (“ANDA”) for a proposed generic version of Intuniv. [Id.]. As the first generic manufacturer to file an ANDA, Actavis would have enjoyed “a 180-day period of exclusivity during which no other generic” manufacturers 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. See Sanofi-Aventis v. Apotex Inc., 659 F.3d 1171, 1175 (Fed. Cir. 2011). After Actavis filed its ANDA, several other companies also sought FDA approval to manufacture generic Intuniv. [ECF No. 343 at 3]. Shire filed suit against Actavis pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), triggering “an automatic 30-month stay of any FDA approval of . . . generic Intuniv.” [ECF No. 343 at 2–3]. After a bench trial, the 30-month stay expired and the FDA approved Actavis’ ANDA. [Id. at 3]. The DPPs argue that it appeared likely that Actavis would receive a favorable verdict. [Id.]. “On April 25, 2013, before any judgment or opinion had entered on [Shire’s] claim, [however,] Shire and Actavis entered into a settlement agreement.” [Id.]. The DPPs argue that the settlement agreement was a reverse payment agreement, which guaranteed Actavis a 180-day exclusivity period in return for Actavis delaying the launch of its generic Intuniv until December 1, 2014. [Id. at 4]. Therefore, the DPPs allege, the Defendants were able to guarantee monopolistic profits which resulted in the DPPs paying artificially

inflated prices for both brand and generic Intuniv. [Id.]. A. The Court’s Order on Class Certification 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 Actavis, from October 19, 2012 through June 1, 2015 (the “Class”).

[ECF No. 343 at 4, 23]. After noting that RDC’s adequacy as a class representative was “a close call,” the Court appointed RDC as the class representative. [Id. at 18, 23]. Though RDC had “entered into a deferred prosecution agreement [(“DPA”)] and settled civil claims brought by the United States in connection with [its alleged] failures to report suspicious opioid purchases,” [id. at 17], “RDC [wa]s under new management, its conduct in this case to date seem[ed] conscientious, and there [wa]s no obvious credibility issue that w[ould] impinge on its ability to adequately represent the class,” [id. at 18]. Finally, there was no evidence of “any conflict among the class as a result of the allegations against RDC . . . .” [Id.]. B. RDC Declares Bankruptcy As part of its DPA with the Government, RDC agreed to forfeit $20 million, providing an initial payment of $10 million, and then an annual payment of $2 million for five years. [ECF No. 406-2 at 3]. In January 2020, RDC informed the Government that it could not make its first $2 million payment. [ECF No. 433-1 at 3]. 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.). Upon RDC’s filing for bankruptcy, the Government rescinded its forbearance in order to protect its rights in bankruptcy. [ECF No. 433-1 at 3–4]. The Government has not indicated that

it will reinstate the underlying criminal prosecution. [Id. at 4]. The parties agree that RDC owes roughly $114 million in total. [ECF No. 405 at 20; ECF No. 433 at 10]. The Defendants argue that RDC “presently has assets totaling $70 million,” [ECF No. 405 at 20], while RDC claims that it has assets of $112 million, [ECF No. 433 at 10].1 The Defendants argue that RDC presently owes them almost $2 million as unsecured creditors. [ECF No. 405 at 12]. RDC responds that it does not owe Actavis anything and only owes Shire $185,666. [ECF No. 433 at 10]. C. Procedural History FWK Holdings, LLC (“FWK”) originally filed this action on December 30, 2016. [ECF No. 1]. On January 11, 2017, RDC filed similar claims, and on March 1, 2017, the Court granted

a joint motion to consolidate the two actions. [ECF No. 19]. RDC is a regional distributor of pharmaceuticals and FWK holds, by assignment, the antitrust claims of Frank W. Kerr Co., a former pharmaceutical wholesaler that entered bankruptcy and subsequently closed. This consolidated action has proceeded in coordination with claims brought on behalf of a putative

1 The Defendants rely on a previous declaration from RDC’s interim Chief Executive Officer which included an estimation of RDC’s assets, [ECF No. 406-1 at 17], whereas RDC references its Summary of Assets and Liabilities filed with the Bankruptcy Court, [ECF No. 433 at 10 n.13]. class of indirect purchasers of Intuniv. See Picone v. Shire U.S. Inc. (Indirect Purchaser Antitrust Class Action), No. 16-cv-12396 (D. Mass).2 After RDC declared bankruptcy in March 2020, Defendants filed their motion to decertify the class on April 3, 2020, [ECF No. 404], and RDC opposed on May 4, 2020, [ECF

No. 433]. II. LEGAL STANDARD Under Rule 23 of the Federal Rules of Civil Procedure

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FWK Holdings LLC v. Shire PLC (Direct Purchaser Antitrust Class Action Complaint), Counsel Stack Legal Research, https://law.counselstack.com/opinion/fwk-holdings-llc-v-shire-plc-direct-purchaser-antitrust-class-action-mad-2020.