STATE OF WISCONSIN v. INDIVIOR INC.

District Court, E.D. Pennsylvania·Decided February 19, 2021·No. 2:16-cv-05073·Unknown

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA __________________________________________ : IN RE SUBOXONE (BUPRENORPHINE : MDL NO. 2445 HYDROCHLORIDE AND NALOXONE) : 13-MD-2445 ANTITRUST LITIGATION : : THIS DOCUMENT RELATES TO:, : : Wisconsin, et al. v. Indivior Inc. et al. : Case No. 16-cv-5073 : __________________________________________: STATE OF WISCONSIN : By Attorney General Brad D. Schimel, et al. : : CIV. A. NO. 16-5073 Plaintiffs, : v. : : INDIVIOR INC. f/k/a RECKITT BENCKISER : PHARMACEUTICALS, INC., et al. : : Defendants. : __________________________________________:

Goldberg, J. February 19, 2021 MEMORANDUM This Opinion resolves numerous motions brought in this multi-district, antitrust matter pursuant to Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). As with the first round of Daubert motions filed in this case, the challenges raised do not warrant exclusion of expert opinions, but rather are more appropriately left for cross-examination. I. FACTUAL AND PROCEDURAL HISTORY1 Defendant Reckitt Benckiser, Inc. (“Reckitt”) manufactures Suboxone, a drug commonly used to combat opioid addiction.2 Suboxone previously came in tablet form. In 2010, citing safety concerns and working in connection with Defendant MonoSol Rx, LLC (“MonoSol”)),3 Reckitt effectuated a change in the administration of this drug, switching from tablet to sublingual film. Various purchasers/consumers of Suboxone claim that this switch was anticompetitive and solely

designed to maintain Reckitt’s market exclusivity—a scheme known as a “product hop.” The Plaintiffs are comprised of a class of Direct Purchasers of Suboxone (“Direct Purchasers” or “DPPs”), a class of End Payors of Suboxone (“End Payors” or “EPPs”), and a group of States’ Attorneys General (the “States”) (collectively, “Plaintiffs”). Plaintiffs claim that Reckitt switched from a Suboxone tablet to a sublingual Suboxone film for the purpose of foreclosing generic competition. According to Plaintiffs, this switch (the “product hop”) was accompanied by Reckitt disparaging the tablet through fabricated safety concerns and ultimately removing Suboxone tablets from the market just as generic Suboxone tablets were able to begin competing. Reckitt is also accused of having manipulated FDA regulations to delay the entry of generic Suboxone onto the market through the filing of an unsubstantiated Citizen Petition and via “misconduct” during the

1 Rather than re-hashing the complicated regulatory background and factual basis of this case, I incorporate by reference the history set forth in my prior decision certifying a class for both the DPPs and EPPs, In re Suboxone, 421 F. Supp. 3d 12 (E.D. Pa. 2019), aff’d, 967 F.3d 264 (3d Cir. 2020), as well as my ruling on Reckitt’s Motion to Dismiss the States’ action. In re Suboxone, No. 13-md-2445, 2017 WL 3967911 (E.D. Pa. Sept. 8, 2017)

2 Reckitt is currently known as Indivior, Inc. In December 2014, Reckitt Benckiser Pharmaceuticals, Inc. was demerged from its prior parent, the Reckitt Benckiser Group PLC, into Indivior PLC. Although Indivior is technically the named defendant in this case, the pleadings and many of the relevant exhibits use the name “Reckitt.”

3 MonoSol is currently known as Aquestive Therapeutics, Inc. (“Aquestive”). Although Aquestive is technically the named defendant, the pleadings and many of the relevant exhibits use the name “MonoSol.” For clarity’s sake, I will therefore refer to Aquestive as “MonoSol.” shared Risk Evaluation and Mitigation Strategies (“REMS”) process. According to Plaintiffs, Reckitt’s conduct foreclosed competition, thereby allowing Reckitt to unlawfully maintain a monopoly in violation of Section 2 of the Sherman Act and overcharge for its Suboxone products. Reckitt readily acknowledges the product switch, but responds that the switch was done for the pro- competitive purpose of marketing and selling an improved, safer, and superior product. Reckitt achieved the switch from tablets to film in collaboration with Defendant MonoSol,

who is a party to the action by the States but not the actions by the DPPs or EPPs. According to the States’ action, MonoSol had patented a method of drug administration through a sublingual film. In December 2006, MonoSol and Reckitt signed an agreement to develop and market a sublingual film form of Suboxone, for which MonoSol would receive royalty payments on the sales of Suboxone film. The States posit that MonoSol effectively conspired with Reckitt to effectuate the entirety of its product hop scheme, foreclosing generic entry and resulting in an increase in its own profits. While Reckitt’s appeal of my class certification ruling was pending, I directed the parties to file any Daubert challenges for those experts whose opinions would not be impacted by the forthcoming ruling on the class issues (Phase I Daubert motions). On November 24, 2020, I issued an opinion granting in part and denying in part those motions. In re Suboxone Antitrust Litig., No.

13-md-2445, 2020 WL 6887885 (E.D. Pa. Nov. 24, 2020). Presently before me are the remaining Daubert challenges involving experts whose opinions were in fact implicated by the Third Circuit’s affirmance of my class certification decision (the Phase II Daubert motions). These Motions are: (1) Reckitt’s Motion to Exclude Certain of the Opinions of Russell Lamb, Ernst Berndt, Rena Conti, and Eric Emch, and Pricing-Related Opinions of Laurence Westreich and Yvonne Tso, and (2) MonoSol’s Motion to Exclude Dr. Ernst Berndt. For the following reasons, I will deny both motions in their entirety. II. STANDARD OF REVIEW Federal Rule of Evidence 702 provides: A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) The expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) The testimony is based on sufficient facts or data; (c) The testimony is the product of reliable principles and methods; and (d) The expert has reliably applied the principles and methods to the facts of the case

Fed. R. Evid. 702. Rule 702 places district courts in the role of “gatekeeper,” requiring courts to “‘ensure that any and all [expert] testimony . . . is not only relevant, but reliable.’” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 147 (1999) (quoting Daubert, 509 U.S. at 589). The party offering an expert must demonstrate, by a preponderance of the evidence, that the expert’s qualifications and opinions comply with Federal Rule of Evidence 702. See Daubert, 509 U.S. at 592–93 (citation omitted). Rule 702 has “a liberal policy of admissibility,” Pineda v. Ford Motor Co., 520 F.3d 237, 243 (3d Cir. 2008) (quotation omitted), and “the rejection of expert testimony is the exception rather than the rule.” Fed. R. Evid. 702, Advisory Comm Notes (2000). As the Court in Daubert stated: “Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.” 509 U.S. at 595.

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