Wisconsin v. Indivior Inc. (In re Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litig.), MDL NO. 2445
| Decision Date | 19 February 2021 |
| Docket Number | MDL NO. 2445,CIV. A. NO. 16-5073,13-MD-2445 |
| Parties | IN RE SUBOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE) 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. Plaintiffs, v. INDIVIOR INC. f/k/a RECKITT BENCKISER PHARMACEUTICALS, INC., et al. Defendants. |
| Court | U.S. District Court — Eastern District of Pennsylvania |
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.
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 theshared 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.
Federal Rule of Evidence 702 provides:
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.
The Daubert inquiry "embodies a trilogy of restrictions on expert testimony: qualification, reliability, and fit." Schneider ex re. Estate of Schneider v. Fried, 320 F.3d 396, 404 (3d Cir. 2003) (citations omitted).
In Waldorf v. Shuta, 142 F.3d 601 (3d Cir. 1998), the United States Court of Appeals for the Third Circuit articulated the "qualification" standard for an expert:
Rule 702 requires the witness to have "specialized knowledge" regarding the area of testimony. The basis of this specialized knowledge "can be practical experience as well as academic training and credentials." . . . We have interpreted the specialized knowledge requirement liberally, and have stated that this policy of liberal admissibility of expert testimony "extends to the substantive as well as the formal qualification of experts." . . . However, "at a minimum, a proffered expert witness . . . must possess skill or knowledge greater than the average layman . . . ."
Id. at 625 (citations omitted).
Construing this standard, the Third Circuit has "eschewed imposing overly rigorous requirements of expertise and [has] been satisfied with more generalized qualifications." In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d Cir. 1994). In other words, "an expert's qualifications should be assessed 'liberally,' recognizing that 'a broad range of knowledge, skills, and training qualify an expert as such.'" Thomas v. CMI Terex Corp., No. 07-3597, 2009 WL 3068242, at *5 (D.N.J. Sept. 21, 2009) (quoting Paoli, 35 F.3d at 741). An expert will not be excluded "simply because [the court] does not deem the proposed expert to be the best qualified or because the proposed expert does not have the specialization that the court considers most appropriate." Holbrook v. Lykes, Bros. S.S. Co., 80 F.3d 777, 782 (3d Cir. 1996). The focus, instead, is on whether the qualifications that an expert does have provide a foundation for the witness to testify meaningfully on a given matter. See Buzzerd v. Flagship Carwash of Port St. Lucie, Inc., 669 F. Supp. 2d 514, 522 (M.D. Pa. 2009).
The reliability restriction requires that the testimony be based upon "the 'methods and procedures of science' rather than on 'subjective belief or unsupported speculation'" and that theexpert have "'good grounds' for his or her belief." Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 321 (3d Cir. 2003) (quotations omitted). In that respect, reliability mandates an examination into the expert's conclusions in order to determine "whether [the conclusions] could reliably flow from the facts known to the expert and [the] methodology used." In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Prod. Liab. Litig., 706 F.3d 217, 225 n.7 (3d Cir. 2013) (quoting Oddi v. Ford Motor Co., 234 F.3d 136, 146 (3d Cir. 2000) (internal quotation marks omitted)).
The Third Circuit has identified the following non-exhaustive factors to be taken into consideration when evaluating the reliability of a particular methodology: (1) whether a method consists of a testable hypothesis; (2) whether the method has been subject to peer review; (3) the known or potential rate of error; (4) the existence and maintenance of standards controlling the technique's operation; (5) whether the method is generally accepted; (6) the relationship of the technique to methods which have been established to be reliable; (7) the qualifications of the expert witness testifying based on the methodology; and (8) the non-judicial uses to which the method has been put. Elcock v. Kmart Corp., 233 F.3d 734, 745-46 (3d Cir. 2000). Although this list of factors is lengthy, not each factor will be relevant to every reliability analysis. The "test of reliability is 'flexible.'" Kumho, 526 U.S. at 141. According to the Supreme Court, "Daubert's list of specific factors neither necessarily nor exclusively applies to all experts." Id. The relevance of the Daubert factors depends "on the nature of the issue, the expert's...
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