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In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation

United States District Court, E.D. Pennsylvania

September 26, 2019



          Goldberg, Judge

         The Plaintiffs in this multi-district litigation case allege anticompetitive conduct by Defendant Reckitt Benckiser, Inc. (“Reckitt”)[1] in connection with their Suboxone product-a drug used to combat opioid addiction. Plaintiffs’ claims focus on a relatively new theory of antitrust liability, referred to as a “product hop, ” pursuant to the unique regulatory and statutory scheme that governs the marketing and distribution of pharmaceutical drugs. Under this theory, a pharmaceutical company makes modest reformulations to a brand-name drug prior to the expiration of its market exclusivity for the purpose of stymieing generic competition and preserving monopoly profits.

         The Plaintiffs are the Direct Purchasers of Suboxone (“Direct Purchasers” or “DPPs”) and the End Payors of Suboxone (“End Payors” or “EPPs”), who claim that Reckitt switched from sublingual Suboxone tablets 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 alleged to have manipulated FDA regulations to delay the entry of generic Suboxone onto the market, thereby unlawfully maintaining a monopoly in violation of Section 2 of the Sherman Act. According to all Plaintiffs, Reckitt’s conduct foreclosed competition and resulted in the overpayment for Suboxone. Reckitt acknowledges the product switch, but strenuously asserts that the switch was done to market and sell an improved and superior product.

         Both the DPPs and the EPPs have now sought class certification. For the following reasons, 1 will certify the DPP class under Federal Rule of Civil Procedure 23(b)(3), deny certification of the EPP class under Federal Rule of Civil Procedure 23(b)(2), and grant certification of the EPP class under Federal Rule of Civil Procedure 23(c)(4).


         To fully understand the basis of Plaintiffs’ antitrust theories and their requests for class certification, a review of the regulatory background and the alleged anticompetitive conduct is necessary. The pertinent facts alleged by Plaintiffs are as follows:[2]

         A. Regulatory Framework – Hatch-Waxman Act

         1. Generic Drug Approval Process

         Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301–92 (“FDC Act”), a manufacturer who creates a new drug must obtain the approval of the Food and Drug Administration (“FDA”) to sell the new drug by filing a New Drug Application (“NDA”). An NDA must include submission of specific data concerning the safety and efficacy of the drug, as well as any information on applicable patents. (Direct Purchaser Plaintiffs’ (“DPP”) Sec. Am. Compl. ¶ 43.)

         In an effort to speed the entry of generic drugs into the market, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman”), 12 U.S.C. § 355. Hatch-Waxman provides brand-name manufacturers with several means, in addition to traditional patent rights, to obtain protection from generic competition for set, and specifically limited, periods of time. For example, for truly new and innovative pioneer drugs, the FDA may grant a brand manufacturer a “new chemical entity” (“NCE”) exclusivity period of five years. (Id.) If an NDA drug treats a rare condition, the FDA may grant seven years of orphan drug exclusivity during which time no corresponding generic drug may be approved or commercialized. (Id. ¶¶ 44–45.)

         The Hatch-Waxman Act also simplified the regulatory hurdles for prospective generic manufacturers by eliminating the need for them to duplicate the clinical studies used to obtain approval for the brand-name counterpart drug. Under the Act, generic manufacturers may file and gain approval for their drugs through filing an Abbreviated New Drug Application (“ANDA”), which relies on the scientific findings of safety and efficacy included by the brand-name drug manufacturer in the original NDA. The ANDA filer must scientifically establish that the generic drug it intends to market is just as safe and effective as the corresponding brand-name drug through demonstrations of bioequivalence, i.e., that the generic product delivers the same amount of active ingredient into a patient’s blood stream for the same amount of time as does the corresponding brand-name drug, and hence has the same clinical effect. (Id. ¶¶ 46–47.)

         Oral drugs proven to be both bioequivalent and pharmaceutically equivalent-meaning the generic drug has the same active ingredient as the branded oral drug-receive an “AB” rating from the FDA, indicating they are therapeutically equivalent to other drugs with the same rating in the same category. In most cases, only oral generic drugs with an AB rating may be substituted by pharmacists for a physician’s prescription of a brand-name drug without the physician’s approval. Once the FDA approves an ANDA and determines that the generic drug is AB-rated to the branded drug, state laws govern how the generic may be substituted for the brand-name drug prescribed by physicians. In most states and under most health plans, a pharmacist may, and in many cases must, substitute an AB-rated generic drug for a prescribed brand-name drug. (Id. ¶¶ 48–49, 55.)

         Competition from low cost AB-rated generic drugs saves consumers billions of dollars a year. When an AB-rated generic drug enters the market, the brand-name company often suffers a rapid, steep decline in sales. AB-rated generic competition enables direct and indirect purchasers to obtain both the generic drugs and the brand-name drugs at substantially lower prices. (Id ¶¶ 56– 58.)

         2. The SSRS/REMS Process

         Under the FDA Amendments Act of 2007, the FDA has the authority to require Risk Evaluation and Mitigation Strategies (“REMS”) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. A REMS can include a medication guide, a package insert, and potential restrictions on the distribution of the drug. If a REMS is required for a particular generic product, the FDA will withhold ANDA approval until such time that an appropriate REMS has been created by the ANDA sponsor. The FDA can also require that ANDA sponsors coordinate with the manufacturer of the branded counterpart drug for the purposes of creating a Single Shared REMS program (“SSRS”), which is a single REMS program to be used by both the sellers of the brand drug and AB-rated generic equivalents. Congress has specifically prohibited brand-name drug manufacturers from using REMS “to block or delay approval of” ANDAs. (Id. ¶¶ 62–65.)

         3. Citizen Petitions

         Pharmaceutical companies have multiple avenues and opportunities through which to communicate their views to the FDA. One such avenue is by filing a “Citizen Petition, ” which provides a forum for individuals or businesses to express and support genuine concerns about the safety, scientific, or legal issues regarding a product at any time before, or after, market entry. To move the FDA to take action regarding drug approval requirements, the petition must include supportive, clinically meaningful data, and the requested relief must be consistent with the Hatch-Waxman statutory and regulatory framework. The FDA must respond to each Citizen Petition within 180 days after the date on which the petition was submitted, and the response may approve the request in whole or in part, or deny the request. A response to a Citizen Petition may be appealed under the Administrative Procedures Act. (Id. ¶¶ 66–70.)

         Plaintiffs claim that abusive and anticompetitive Citizen Petitions have become an increasingly common problem in the last several years and, in some cases, are filed with the intended effect of delaying the approval of generic drugs while the FDA evaluates the Citizen Petition. To deal with the potential anticompetitive abuse of the citizen petition process, Congress passed the Food and Drug Administration Amendments Act (“FDAAA”), enacted on September 27, 2007, which adds new section 505(q) to the FDC Act. This section provides that the FDA may not delay approval of an ANDA application because of a requirement to take action related to the pending Citizen Petition unless the delay is necessary to protect the public health. (Id. ¶¶ 73, 75, 77.)

         B. FDA Approval of Suboxone Tablets

         Defendant Reckitt developed two buprenorphine products for the treatment of opioid addiction: (a) a single-entity buprenorphine product, Subutex, intended for a brief induction stage, and (b) Suboxone, a buprenorphine-naloxone combination for post-induction maintenance treatment. At the time of their introduction, Subutex tablets and Suboxone tablets were the only pharmaceuticals on the market that provided maintenance treatment for patients suffering from opioid addiction that could also be prescribed in an office setting for the patient’s home use. All other opioid addiction maintenance treatments, such as methadone, could only be dispensed at a clinic. (Id. ¶ 82.)

         Although the FDA approved Reckitt’s NDA for Suboxone tablets in 2002, Reckitt had no patent protection and relied primarily on seven years of orphan drug exclusivity. Orphan drug designation is granted where (a) a product is intended to treat a disease or condition that has a U.S. prevalence of less than 200, 000 persons; or (b) where the sponsor can show that there is no reasonable expectation that the costs of developing and making the drug will be recovered from U.S. sales, despite the fact that the product treats a disease or condition that has a U.S. prevalence of 200, 000 or more individuals. FDC Act § 526(a)(2)(A & B). Suboxone’s orphan drug exclusivity expired on October 8, 2009. (Id. ¶ 84.)

         C. Alleged Anticompetitive Conduct

         1. Product-Hopping: Development of Suboxone Film and the Alleged Destruction of the Tablet Market

         In early 2006, in an effort to avoid generic competition with its Suboxone product, Reckitt allegedly began searching for a way to replace Suboxone tablets with a product not subject to automatic generic substitution. Reckitt opted to develop a Suboxone sublingual film, which, even though bioequivalent to tablets, would not be AB-rated to tablets-and thus not automatically substitutable by pharmacists due to a difference in dosage form. Although Suboxone film cost more to make, Reckitt allegedly started exploring a strategy in the United States to coerce doctors to prescribe and pharmacists to dispense film in lieu of tablets. (Id. ¶¶ 86–87, 89.)

         The NDA for Suboxone film was submitted on October 20, 2008, and was approved on August 30, 2010. The three-year exclusivity for Suboxone film extended to August, 2013. In addition, the film is covered by patent 8, 017, 150 (“the ’150 patent”), which will not expire until September 2023. (Id. ¶¶ 91–92.)

         Plaintiffs allege that there are few differences between Suboxone film and Suboxone tablets, and that film is not superior to tablets. Plaintiffs point out that the two products are so similar that Reckitt submitted safety and efficacy studies performed on Suboxone tablets when seeking approval of the Suboxone film NDA. The tablets and film are alleged to have equivalent bioavailability, meaning that the products release the same amount of active ingredients into a patient’s bloodstream. (Id. ¶ 93.)

         Although Reckitt indicated in its NDA that the film’s individual packaging reduced the risk for accidental pediatric exposure to the drug, Plaintiffs assert that the evidence provided by Reckitt on this issue was flawed. Indeed, the FDA expressed concerns that the film may present increased risk for accidental pediatric exposure because the filmstrip dissolves more quickly than the tablet and, therefore, may be more difficult for a child to spit out in the event of exposure. The FDA also had concerns that film had a higher risk of abuse than tablets because film is easier to conceal, dissolve, and inject. Finally, the FDA informed Reckitt that it did “not agree that the packaging for [Suboxone film] provides meaningful incremental protection against pediatric exposure.” (Id. ¶¶ 94–97.)

         Once the FDA approved Suboxone film NDA in 2010, Reckitt allegedly launched a fraudulent sales and marketing campaign against the tablet for the purpose of diverting sales from the tablet, which would soon face generic competition, to the patent-protected film. After Suboxone was originally launched in 2002, Reckitt spent several years building the market by (a) generating public acceptance/demand for office-based treatment; and (b) building a network of doctors that were able and willing to offer Suboxone treatment to addicts. This network of doctors had more influence over the product selection than is usually the case because only 12, 800 doctors have government certification to treat Suboxone patients, and even fewer actually treat Suboxone patients. Moreover, there are limits on how many Suboxone patients a doctor can treat at any one time. These factors make it difficult for patients to find and/or switch doctors. (Id. ¶¶ 102, 105, 109–110.)

         Understanding the crucial role doctors played in the distribution of Suboxone, Reckitt allegedly began creating economic disincentives to penalize doctors who did not push their patients to film. Reckitt also developed a program providing economic incentives to doctors who did push their patients to use film. Even though tablets were purportedly cheaper to produce, Reckitt priced tablets higher than film. (Id. ¶¶ 111–115, 120.)

         According to Plaintiffs, Reckitt then implemented a massive fraudulent sales and marketing campaign to advance the conversion of all Suboxone prescriptions from tablets to film. This “product-hopping marketing campaign” included several tactics, including: (a) a wide-ranging fraudulent marketing campaign in which Reckitt’s sales representatives promoted only the film formulation and discouraged physicians from writing prescriptions for the original tablet formulation under the pretext of alleged safety concerns with the tablet; (b) publicly announcing that Reckitt was pulling Suboxone tablets from the market due to the false safety issues; and (c) publicly seeking an FDA determination that Suboxone tablets were voluntarily pulled from the market by Reckitt due to “safety” issues (even though Reckitt had not actually pulled the tablets from the market). On September 25, 2012, Reckitt publicly announced that it would discontinue selling branded Suboxone tablets in the U.S. based on purported safety reasons. Yet, Reckitt continued selling the tablets until early March 2013, while it implemented the conversion to film. (Id. ¶¶ 130–132.)

         2. Abuse of the SSRS/REMS Process

         Aside from the product switch and concurrent attempted destruction of the tablet market, Reckitt purportedly engaged in a series of actions to delay generic competition, one of which was abuse of the SSRS/REMS process. (Id. ¶ 134.)

         In 2009 and 2011, Actavis, Inc. (“Actavis”) and Amneal Pharmaceuticals, LLC (“Amneal”) (collectively, the “Generics”), respectively, filed ANDAs for generic Suboxone tablets. On December 22, 2011, the FDA approved a REMS performed by Reckitt on the issue of the risk of pediatric exposure to Suboxone tablets. Through the REMS, the FDA required that Reckitt address pediatric exposures via FDA-approved labeling. On January 6, 2012, the FDA sent all sponsors of pending ANDAs for Suboxone tablets a notification letter stating that all branded and generic Suboxone products would be subject to a Single Shared REMS program (“SSRS”). ANDA filers were directed to contact Reckitt to collaborate on the creation of an SSRS program. The FDA set a compliance date of May 6, 2012 for the SSRS. The FDA gave a short turn-around time, assuming that the recently approved REMS performed by Reckitt would simply be amended to add the bioequivalent generic products. (Id. ¶¶ 135–138, 140.)

         Plaintiffs allege that Reckitt used the SSRS as a means to undermine and delay generic entry by feigning cooperation in the SSRS development process. During the next six months, ANDA applicants for generic Suboxone Tablets sought to negotiate the SSRS process in good faith, but Reckitt allegedly delayed by making unreasonable demands on the generic companies as a precondition of Reckitt’s cooperation in the SSRS, despite the fact that such delay tactics are expressly prohibited by 21 U.S.C. § 355-1(f)(8). Reckitt reportedly turned down numerous invitations to participate in meetings with the Generics, and refused to engage in substantive discussions until the Generics agreed to a number of conditions, including “an upfront agreement that all manufacturers would share the costs of product liability for future potential lawsuits.” Plaintiffs further allege that Reckitt refused to share non-public information from its REMS program until its demands were met. (Id. ¶¶ 142–145.)

         The Generics complained to the FDA about Reckitt’s alleged delay tactics, and a meeting was held on June 18, 2012. The FDA acknowledged during this meeting that it could not compel Reckitt to share its non-public REMS program, and suggested that the Generics develop a new SSRS without using Reckitt’s information. Although the FDA implored Reckitt and the Generics to work together in good faith and not attempt to block or delay, Plaintiffs claim that Reckitt’s obstructionist actions continued, and that Reckitt refused to cooperate unless the Generics agreed to provide Reckitt veto authority or a super-majority vote on all issues relating to the SSRS. Two days before the SSRS was submitted, Reckitt allegedly argued, for the first time, that an important element of the REMS had been omitted, and it refused to sign the SSRS. In mid-September 2012, the FDA provided comments regarding the proposed new SSRS, and Reckitt maintained that it desired to continue collaborating. Ultimately, on October 3, 2012, given Reckitt’s intransigence, the Generics sought a waiver for approval of their Generics-only SSRS on October 3, 2012. (Id. ¶¶ 145–150.)

         3. Sham Citizen Petition

         Reckitt learned that the FDA planned to grant final approval to several generic tablets in the fall of 2012. By that time, Reckitt had not converted all of its Suboxone unit sales from tablet to film. (Id. ¶ 151.)

         On September 25, 2012, Reckitt formally announced its intent to permanently withdraw Suboxone tablets from the U.S. market for purported reasons of safety. That same day, Reckitt filed a Citizen Petition with the FDA to block approval of all pending Suboxone ANDAs on alleged safety grounds. The Citizen Petition requested that the FDA take three actions: (a) refrain from approving any buprenorphine NDA or ANDA for the treatment of opioid addiction that did not include a targeted pediatric exposure education program; (b) refrain from approving applications for buprenorphine for opioid addiction that lacked unit-dosage packaging; and (c) refrain from approving any buprenorphine/naloxone ANDA for addiction treatment until the FDA determined whether the reference listed drug, Suboxone tablets, had been discontinued for safety reasons. (Id. ¶¶ 152–154.)

         As to the first requested action, Plaintiffs allege that it was baseless since Reckitt was well aware (a) that its “targeted pediatric exposure education program” was not part of the FDA-approved REMS or labeling for Suboxone tablets, and (b) that the FDA-approved REMS and labeling for Suboxone tablets already contained the substantive material that had to be mimicked by ANDA filers in order for them to gain final FDA approval. Thus, the FDA had no statutory or regulatory ability to require ANDA filers to mimic non-approved labeling and REMS materials in order to obtain approval. As to the third request, Plaintiffs allege that it was baseless because Reckitt had not actually discontinued its sale of Suboxone tablets, and the FDA had no authority to engage in advisory opinions about the reasons why a drug had been discontinued when, in fact, it had not actually been discontinued. Finally, as to the second request, Plaintiffs allege that it was baseless because Reckitt had successfully sold Suboxone tablets in bulk containers for over ten years, the tablets were sold in child-resistant bottles, the tablets had FDA-approved labeling and REMS, the FDA did not believe that unit-dose packaging was superior to child-resistant bottles, and Reckitt did not present clinically significant, well-controlled studies demonstrating that Suboxone tablets in bulk containers were unsafe. (Id. ¶¶ 157, 162–163.)

         In short, according to Plaintiffs, Reckitt failed to provide well-controlled, statistically-significant scientific support for its call for the FDA to refuse to approve ANDAs for generic Suboxone tablets, which made the Citizen Petition a sham. Indeed, Reckitt was aware of pediatric exposure issues regarding Suboxone as early as 2002, having sold Suboxone tablets in blister packaging in Canada and Europe for years, yet purportedly used the packaging issue to delay the launch of generic competitors by raising the safety issues at the last possible moment. (Id. ¶¶ 171, 173–74.)

         Ultimately, on February 22, 2003, the FDA denied the Citizen Petition, noting the lack of evidentiary support and acknowledging the inconsistency between Reckitt’s Citizen Petition and its prior behavior. It referred Reckitt’s conduct to the Federal Trade Commission (“FTC”) for antitrust investigation. In the interim, however, Reckitt made millions in additional Suboxone sales. (Id. ¶¶ 155, 182.)

         4. The Tablet Withdrawal

         Immediately after the denial of Reckitt’s Citizen Petition, the FDA granted final approval to the ANDAs of two generic manufacturers, Amneal and Actavis, for generic versions of Suboxone tablets. Three weeks later, on March 18, 2013, Reckitt withdrew its Suboxone tablets from the market. As a result, a patient would receive the generic Suboxone tablets only if a doctor specifically prescribed the generic tablets, which doctors were less likely to do because of Reckitt’s disparagement of generic tablets. (Id. ¶¶ 184–185.)

         D. Effects on Competition and Damages

         Plaintiffs allege that Reckitt’s actions had the effect of substantially destroying demand for Suboxone tablets before generic tablets entered the market. Absent Reckitt’s actions, the generic Suboxone tablets would theoretically have entered the market and competed with branded Suboxone tablets, resulting in migration from the more expensive brand to the less-expensive generic. Both the Direct Purchaser Class and the End Payor Class allege that this conduct has caused their members to pay inflated prices for co-formulated buprenorphine/naloxone products. (Id. ¶¶ 186– 187, 189.)

         E. Causes of Action

         In their Second Amended Complaint, the Direct Purchasers bring claims under § 2 of the Sherman Act for: (1) unlawful maintenance of monopoly power through an overarching scheme to prevent or delay generic competition (“Count I”); (2) unlawful maintenance of monopoly power by conversion of the market from tablet to film formulation (“Count II”); (3) unlawful maintenance of monopoly power by intentionally delaying the SSRS process and violating 21 U.S.C. § 355-1(f)(8) (“Count III”); (4) unlawful maintenance of monopoly power by filing a sham Citizen Petition (“Count IV”); and (5) unlawful maintenance of monopoly power by fraudulently delaying the filing of the Citizen Petition until the eve of generic ANDA approval (“Count V”).

         The End Payors assert the following causes of action in their Second Amended Complaint: (1) monopolization and monopolistic scheme under state law (“Count I”); (2) attempted monopolization under state law (“Count II”); (3) unfair and deceptive trade practices under state law (“Count III”); (4) injunctive and declaratory relief under section 16 of the Clayton Act for Reckitt’s violations of section 2 of the Sherman Act (Count IV), and (5) unjust enrichment under state law (“Count V”).[3]


         The Direct Purchaser Plaintiffs’ (“DPPs”) Motion for Class Certification relies, in large part, on the expert report of Dr. Russell Lamb. Dr. Lamb opines that the DPPs can prove-using evidence common to the class-that the direct purchasers of Suboxone Tablets suffered antitrust injury on a class-wide basis. Dr. Lamb has also calculated damages the class incurred as a result of Reckitt’s hard switch scheme. Reckitt argues that Dr. Lamb’s opinions and report are fundamentally unsound and should be excluded from consideration. The DPPs respond that Reckitt’s Motion is nothing more than an attack on the merits of Plaintiffs’ claims rather than a legitimate Daubert challenge to Dr. Lamb’s methodology.

         The United States Supreme Court has strongly suggested that a full examination pursuant to the decision in Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), is necessary prior to class certification. See WalMart Stores, Inc. v. Dukes, 564 U.S. 338, 354 (2011) (“The District Court concluded that Daubert did not apply to expert testimony at the certification stage of class-action proceedings. We doubt that is so . . .” (internal citation omitted)). Interpreting Dukes, the United States Court of Appeals for the Third Circuit has held that “a plaintiff cannot rely on challenged expert testimony, when critical to class certification, to demonstrate conformity with Rule 23 unless the plaintiff also demonstrates, and the trial court finds, that the expert testimony satisfies the standard set out in Daubert.” In re Blood Reagents Antitrust Litig., 783 F.3d 183, 187 (3d Cir. 2015).

         Because my ruling on Reckitt’s Daubert motion affects the outcome of my class certification decision, I will address that issue at the outset.

         A. 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) (citation omitted), and “embodies a trilogy of restrictions on expert testimony: qualification, reliability, and fit.” Schneider v. Fried, 320 F.3d 396, 404 (3d Cir. 2003) (citations omitted).

         Reckitt does not challenge either Dr. Lamb’s qualification or the “fit” of his testimony, but rather focuses solely on the reliability of his methodology.

         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 the expert 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).

         Importantly, the rule does not require the party proffering the expert to demonstrate the “correctness” of the expert’s opinion. In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 744 (3d Cir. 1994) (concluding that the “evidentiary requirement of reliability” amounts to a lower burden “than the merits standard of correctness”). Rather, the party need only demonstrate “by a preponderance of the evidence” that the expert’s opinion bears adequate indicia of reliability. Id. Indeed, “[a] judge will often think that an expert has good grounds to hold the opinion . . . even though the judge thinks the opinion otherwise incorrect.” Id. Therefore, “[t]he focus . . . must be solely on principles and methodology, not on the conclusions that they generate.” Daubert, 509 U.S. at 595. “When the methodology is sound, and the evidence relied upon sufficiently related to the case at hand, disputes about the degree of relevance or accuracy (above this minimum threshold) may go to the testimony’s weight, but not its admissibility.” i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 852 (Fed. Cir. 2010), aff'd, 564 U.S. 91 (2011).

         B. Discussion

         The challenged portion of Dr. Lamb’s report analyzes whether the DPPs can prove that the direct purchasers of Suboxone Tablets suffered an antitrust injury on a class-wide basis using evidence common to the class. Dr. Lamb considers the DPPs’ claim that Reckitt’s scheme involved three major anticompetitive components: inflation of the brand tablet prices paid by all class members, delay of generic entry, and inflation of the film’s share of the Suboxone market that prevented generic tablets from being dispensed. These practices, according to the DPPs, helped Reckitt shift the market from tablet to film. Assuming these facts, Dr. Lamb concludes that all class members suffered three types of aggregate classwide damages corresponding to the above effects: (1) overcharges relating to Reckitt’s increase of brand tablet prices before generic tablets launched; (2) overcharges relating to Reckitt’s delay of the entry of generic tablets into the market; and (3) overcharges relating to the hard switch of the market from tablets to film, meaning that when lower-priced generic tablets came on the market, prescriptions were already being written for film.

         Reckitt presses five challenges to the reliability of Dr. Lamb’s report: (1) Dr. Lamb’s methodology improperly attributes damages to lawful, pro-competitive pricing practices; (2) Dr. Lamb’s but-for price calculations reflect “chargeback” sales revenue that has no place in a calculation of alleged overcharges; (3) Dr. Lamb’s report fails to show a link between the alleged “hard switch scheme” and the “but-for” market share of generic products; (4) Dr. Lamb’s calculation of but-for market share using analogs is arbitrary; and (5) Dr. Lamb’s methodology does not account for generic bypass. I address each argument separately.

         1. Whether Dr. Lamb’s Improperly Attributes Damages to Lawful Pro-Competitive Pricing Practices

         Reckitt first argues that Dr. Lamb’s methodology for determining class-wide injury and damages is flawed because it relies upon the assumption that Plaintiffs can claim antitrust injury from Reckitt’s practice of selling Suboxone film at a lower price than Suboxone tablets. Reckitt reasons that unilateral above-cost pricing is lawful, unless there are allegations of predatory pricing. According to Reckitt, there is no legal basis to conclude that Suboxone film pricing was excessively low, as even Dr. Lamb concedes that Reckitt was not selling film below its cost. Reckitt also posits that there is no legal basis to conclude that it was required to price tablets at parity with film. Thus, Reckitt urges that Dr. Lamb’s faulty assumption of antitrust injury due to pricing practices invalidates all elements of his damages and injury analysis.

         In support of this argument, Reckitt relies heavily on the Supreme Court decision in Comcast Corp. v. Behrend, 569 U.S. 27 (2013). There, the plaintiffs sought to certify an antitrust class of Comcast subscribers, under Rule 23(b)(3), and proposed four theories of antitrust impact. Id. at 30. On class certification review, the district court certified only one of the theories for class treatment. Id. at 36. In calculating damages, however, the plaintiffs’ expert assumed the validity of all four theories of antitrust impact initially advanced by the plaintiffs and sought to establish a “but for” baseline to show what competitive prices would have been if there had been no antitrust violations. The expert admitted that his model calculated damages resulting from “the alleged anticompetitive conduct as a whole” and did not attribute damages to any one particular theory of competitive impact. Id. at 36–37. The Third Circuit found no problem in this methodology, stating that “[a]t the class certification stage we do not require that Plaintiffs tie each theory of antitrust impact to an exact calculation of damages, but instead that they assure us that if they can prove antitrust impact, the resulting damages are capable of measurement and will not require labyrinthine individual calculations.” Id. at 37.

         The Supreme Court rejected the Third Circuit’s reasoning, holding that “such assurance is not provided by a methodology that identifies damages that are not the result of the wrong.” Id. at 37. It found that “at the class-certification stage . . . any model supporting a plaintiff’s damages case must be consistent with its liability case, particularly with respect to the alleged anticompetitive effect of the violation.” Id. at 35 (quotations omitted). The Court went on to note that the expert’s methodology might have been sound and produced commonality of damages if all four of the alleged antitrust theories remained in the case. Id. at 37. But because only one of the theories was certified as appropriate for class treatment, the plaintiffs’ model could not reliably demonstrate impact to the class from the sole remaining theory. Id. Rather, in order for the plaintiffs’ model to provide any probative evidence of antitrust impact or damages from the single theory found appropriate for class treatment, the model needed to have been able to isolate that single theory’s effect from the effects of the three theories not suitable for class treatment. Id. at 38.

         Here, similar to Comcast, the DPPs have multiple theories of antitrust impact. The DPPs contend that the entirety of Reckitt’s “hard switch” scheme resulted in the antitrust injury at issue. That conduct included not only the increase in the price of tablets and decrease in the price of film, but also the introduction of Suboxone film onto the market, the removal of Suboxone tablets from the market several months prior to generic approval, the dissemination of false safety concerns with Suboxone tablets, and the disparagement of Suboxone tablets. Dr. Lamb relies on the combination of those theories to set forth his model of antitrust damages. Reckitt presses that because one of these theories-the pricing of Suboxone film and/or Suboxone tablets-is not actionable under antitrust law, Dr. Lamb’s report, which is premised on the cumulative anticompetitive conduct, cannot reliably show antitrust damages.

         Reckitt’s argument disregards the distinction between this case and Comcast. Here, notwithstanding Reckitt’s challenge to the DPPs’ pricing allegations, none of the DPPs’ theories has been invalidated or deemed unsuitable for class determination. Indeed, considering the validity of these allegations at the motion to dismiss stage, I previously found that Plaintiffs’ allegations, considered collectively, stated a plausible claim of exclusionary conduct as required for an antitrust violation. And I reached this conclusion even though the pricing practices allegations alone could not give rise to such a claim. In re Suboxone, 64 F.Supp.3d 665, 683–84 n.9 (E.D. Pa. 2014); see also ZF Meritor, LLC v. Eaton Corp., 696 F.3d 254, 277 (3d Cir. 2012) (holding that, even absent allegations of predatory pricing, an antitrust plaintiff may rely on the exclusionary effect of prices together with other forms of anticompetitive conduct in order to state a plausible antitrust claim), cert denied, 569 U.S. 958 (2013).

         Reckitt’s challenge to Dr. Lamb’s reliance on Reckitt’s pricing practices for Suboxone film would require a broad inquiry into the merits of the DPPs’ antitrust allegation-an inquiry in which I need not engage at this stage of the litigation. The recent decision of In re Processed Egg Products Antitrust Litigation, 312 F.R.D. 171 (E.D. Pa. 2015) is instructive on this point. There, the plaintiffs sought class certification of several classes, relying in part on expert testimony that assumed the viability of plaintiffs’ theory of liability. Id. at 190–91. Citing Comcast, the defendants sought to exclude the expert’s opinions because of alleged legal defects in plaintiffs’ theory on which the expert’s damages model was premised. Id. at 191. The district court rejected this argument, noting that the “posture of [the] case is different from Comcast, because none of the alleged [antitrust theories] have been found inappropriate for class treatment.” Id. at 192. The court went on to explain:

Defendants would have it that Plaintiffs must, at this stage, disaggregate each alleged anticompetitive action and isolate its effect. Such a requirement, Defendants argue, is the only way to ensure that the Court does not face the same difficulties that arose in Comcast- that is, “[i]f one or more modes of challenged conduct are found to be lawful, [the expert’s] damage model . . . becomes entirely useless, as did the damage model in Comcast.” . . . But Comcast does not stand for the broad proposition Defendants ascribe to it. Although the Court must engage with the merits of the case when they weigh upon the Court’s analysis of Rule 23, the Court must not engage in “free– ranging merits inquiries at the certification stage.” . . . Here, Defendants’ proposed disaggregation requirement is based on hypotheticals that the Court has no basis to consider at this moment, as there was no argument at the class certification stage from Defendants that any disaggregated part of the alleged conspiracy should be found lawful or otherwise incapable of common proof. Defendants nevertheless assert that because “now is the time to demonstrate compliance with Rule 23, ” the Court should refuse certification because of the possibility that some conduct that [the expert] included in his damages measurement will be found to relate to “damages” ultimately held to be unrecoverable. But Defendants are asking the Court to do more than ensure compliance with Rule 23-Defendants ask the Court to ensure that compliance with Rule 23 will withstand any possible development moving forward. That is not what Comcast required, as implied by the Supreme Court’s note that the plaintiffs’ methodology in Comcast “might have been sound . . . if all four of those alleged distortions remained in the case.” Id. . . . That is, likewise, not what Rule 23 requires as Rule 23(c)(1)(C) provides that “[a]n order that grants or denies class certification may be altered or amended before final judgment”-such a provision would have little utility if the Court had to ensure that a class certification ruling could withstand any potential future developments in a case. The Court would, under Defendants’ reading of Rule 23, need to determine not just that common issues are likely to predominate over individual ones, but that Plaintiffs have indeed proven the merits of every aspect of their case, such that no development in the case could threaten the initial decision on certification of the class. Class certification is not such a free–ranging inquiry.

In re Processed Egg Prods., 312 F.R.D. at 192–93.

         This case falls into a similar posture. While the parties debate whether Reckitt’s increase in the price of Suboxone tablets and concurrent sale of Suboxone film at a lower price constitutes unlawful antitrust activity, this dispute is not at issue in either this Daubert motion or the Motion for Class Certification. “Daubert does not require a plaintiff to prove causation of damages ‘twice- they do not have to demonstrate to the judge by a preponderance of the evidence that the assessments of their experts are correct, they only have to demonstrate by a preponderance of evidence that their opinions are reliable’ and fit the facts of the case.” In re Linerboard Antitrust Litig., 497 F.Supp.2d 666, 675 (E.D. Pa. 2007) (emphasis in original) (quoting In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 744 (3d Cir. 1994)). Indeed, “the standard for admitting expert testimony on antitrust damages is lower than a plaintiff’s burden of proof in establishing antitrust damages.”[4] Id. at 676.

         Here-where the DPPs’ theory is not that any one act itself was unlawful, but that all the acts taken together constituted an antitrust violation-an expert need not segregate and attribute a fixed amount of damages to any one act. Rather, “[i]n constructing a hypothetical world free of defendants’ exclusionary activities, the plaintiffs are given some latitude in calculating damages, so long as their theory is not wholly speculative.” Bonjorno v. Kaiser Aluminum & Chem. Corp., 752 F.2d 802, 812 (3d Cir. 1984). Once a jury finds that some unlawful activity by the defendant caused the antitrust injury, the damages may be determined without strict proof of which act caused the injury, so long as the damages calculation is free from speculation or guesswork. Id. at 813.

         In LePage’s Inc. v. 3M, 324 F.3d 141 (3d Cir. 2003), the Third Circuit addressed a similar attack on an expert damage report. The defendant, challenging a jury’s verdict for the plaintiff under § 2 of the Sherman Act, contended that “a plaintiff cannot succeed in a § 2 monopolization case unless it shows that the conceded monopolist sold its product below cost.” Id. at 144. As part of the defendant’s argument, it claimed that the plaintiff’s damages expert opinion was based on improper assumptions and should have been excluded, and that the expert’s theory failed to disaggregate the damages based on lawful versus unlawful conduct by defendant. Id. at 164–65. Finding no error in the admissibility of the expert, the Third Circuit remarked that “[t]he relevant inquiry is the anticompetitive effect of [defendant’s] exclusionary practices considered together, ” and not the legality of its individual actions.” Id. at 162. Because the jury found that defendant’s actions as a whole violated § 2 of the Sherman Act, the expert’s disaggregation of damages-i.e., separating damages arising from defendant’s lawful conduct or other facts from damages arising from defendant’s unlawful conduct-was “unnecessary, if not impossible.” Id. at 166. In turn, the Court found no error in the trial court’s admission of the expert testimony.[5] Id.

         In short, unlike in Comcast, where three of the four theories on which the expert relied were deemed inappropriate for class treatment, the DPPs’ pricing allegations here remain a viable part of their overall antitrust theory.[6] The relevant inquiry here requires that I “look to the monopolist’s conduct taken as a whole rather than considering each aspect in isolation.” Philadelphia Taxi Assoc., Inc. v. Ubert Techs., Inc., 886 F.3d 332, 339 (3d Cir. 2018) (quoting LePage’s, 324 F.3d at 162); see also In re Niaspan Antitrust Litig., No. 13-mdl-2460, 2019 WL 3816829, at *15 (Aug. 14, 2019) (admitting expert damages model premised on the entire anticompetitive scheme and declining to require expert to parse each type of conduct). Under such a theory, “it would be extremely difficult, if not impossible, to segregate and attribute a fixed amount of damages to any one act as the theory was not that any one act in itself was unlawful, but that all the acts taken together showed a [Sherman Act] violation.” LePage’s, 324 F.3d at 166. Dr. Lamb’s measurement of “class-wide damages” relies on the totality of this alleged exclusionary conduct. (Lamb Report ¶ 125–167.) Accordingly, I will deny Reckitt’s Daubert Motion to Exclude Dr. Lamb’s Opinions on this ground.

         2. Whether Dr. Lamb’s But-For Price Calculations Improperly Reflect “Chargeback” Sales Revenue

         Reckitt next challenges Dr. Lamb’s use of “chargebacks” in his attempts to calculate the real-world price of generic tablets.

         Chargebacks are “payments wholesalers [direct purchasers] receive from manufacturers when they sell at a discounted price to downstream customers [end payors] – as a price discount to the direct purchaser class.” (Report of Reckitt’s Expert Parker Normann (“Normann Expert Report”) ¶ 133.) Chargebacks arise when a manufacturer has an arrangement with a downstream purchaser to sell a drug at a specific price, often below the price paid by the wholesaler. The wholesaler/direct purchaser sells the drug to the downstream purchaser at the lower price and then “charges back” to the manufacturer the difference between the price it paid and the price at which it sold the drug in order to be made whole on the transaction. (Lamb Dep. 276:13–277:3.)

         According to Reckitt, chargebacks are a type of sales revenue and not part of the purchase transaction-i.e., it is only through a potential subsequent sale to a downstream purchaser that chargebacks are properly understood as part of the sales transaction-and thus they should only be considered in a lost profits analysis, not an overcharge analysis. It asserts that Dr. Lamb’s damages calculation purports to be an “overcharge” analysis, but is, in actuality, a “lost profits” analysis due to his consideration of “chargebacks” in determining the but-for generic tablet price. More specifically, in calculating what direct purchasers paid for generic tablets, Dr. Lamb subtracts out the amount the direct purchasers received in chargebacks from the manufacturers, thus creating the appearance that direct purchasers paid less for generic tablets than they actually did. Reckitt posits that such chargebacks cannot be part of the overcharge analysis because their inclusion “substantially understate[s] generic pricing, resulting in grossly inflated ‘overcharge’ calculations.” (Reckitt’s Reply Br. 8.) Reckitt’s expert, Dr. Normann, opines that a chargeback is “not a discount on the purchase price paid, but a reimbursement from the generic manufacturer to the wholesaler for a separate service, ” making it “irrelevant as a matter of definition, to an ‘overcharge’ damages methodology that seeks to compare the prices paid to the prices that would have been paid in the but-for world.” (Normann Report ¶¶ 137–138 (emphasis in original).)

         Dr. Lamb responds that Dr. Normann is mistaken as “chargebacks constitute reductions in the prices paid by direct purchasers of branded Suboxone tablets and film and generic Suboxone tablets.” (Lamb Rebuttal Report ¶ 170.) He acknowledges that his damages analysis focuses on whether proposed class members were overcharged as a class and does not calculate lost profits. (Dep. Of Charles Lamb (“Lamb Dep.”) 155:22–156:24.) He explains, however, that an “overcharge” analysis in an antitrust context looks at the price paid in the actual world compared with the price that would have been paid in a but-for world free of the alleged misconduct. (Id. at 157:19–158:3, 159:22–160:3.) Dr. Lamb then notes numerous sources which define the net price of a generic as including chargebacks received from wholesalers. (Lamb Rebuttal Report ¶¶ 170– 174.)

         The conflicting opinions on the soundness of including chargebacks in an overcharge analysis bear not on the reliability of Dr. Lamb’s analysis, but rather on the correctness of his opinion. When conducting a Daubert analysis, a court may not “evaluate the credibility of opposing experts or the persuasiveness of their conclusions. Walker v. Gordon, 46 Fed.App’x 691, 695 (3d Cir. 2002); see also In re Chocolate Confectionary Antitrust Litig., 289 F.R.D. 200, 210 (M.D. Pa. 2012) (“Obviously, Defendants vigorously dispute Dr. Tollison’s conclusions, but the court finds that these disputes go to the weight, and not the admissibility, of Dr. Tollison’s expert testimony.”). Rather, it is enough to find that the methodology used by the expert is reliable. Walker, 46 Fed.App’x at 695.

         Reckitt has not cited any case law establishing that Dr. Lamb’s methodology is inherently unscientific or unreliable. “When calculating damages, ‘[t]he usual measure in an over-charge case is the difference between the illegal price that was actually charged and the price that would have been charged ‘but for’ the violation ..... ’” In re Chocolate Confectionary, 289 F.R.D. at 222 (quoting Comcast, 655 F.3d at 203 (further quotations omitted)). “Because of the practical difficulties in calculating damages based on an illusory ‘but-for’ world, courts do not require damages to be reduced to a mathematical certainty. Rather courts require that damages be established ‘as a matter of just and reasonable inference.’” Id. (quoting Comcast, 655 F.3d at 203– 04). In other words, at the class certification stage, district courts need not search for “hard factual proof, but [instead] for a more thorough explanation of how the pivotal evidence behind plaintiff’s theory can be established.” In re New Motor Vehicles Canadian Export Antitrust Litig., 522 F.3d 6, 29 (1st Cir. 2008) (emphasis in original).

         As Dr. Lamb’s report provides a plausible method for calculating damages, and as credibility disputes between experts cannot be resolved at this stage, I decline, under Daubert, to exclude Dr.

         Lamb’s opinions on the chargeback issue.

         3. Whether Dr. Lamb’s Failure to Show a Link Between the Alleged “Hard Switch Scheme” and the “But-for” Market Share of Generic Products Requires Exclusion of His Report

         Reckitt next contends that Dr. Lamb’s methodology contains a fundamental disconnect. On one hand, the alleged anticompetitive conduct all occurred prior to generic entry in March 2003, and was designed to switch potential prescriptions of branded Suboxone tablets to film. On the other hand, Dr. Lamb’s largest category of damages calculates injury flowing from the decisions of physicians-made after the end of the allegedly anticompetitive course of conduct-to prescribe film instead of generic tablets. According to Reckitt, Dr. Lamb leaves unanswered the question of what, after generic entry, prevented doctors from prescribing generic tablets as opposed to branded film. Moreover, Reckitt alleges that Dr. Lamb gives no reason to conclude that pre-2013 “Hard Switch Conduct” (prior to generic entry) continues to affect market prices and shares today. As such, Reckitt asserts that Dr. Lamb’s calculation-which assumes that the anti-competitive conduct is responsible for the current high price and low market share of generics-is unsupported.

         Reckitt’s argument is effectively a challenge to causation. “A consumer alleging antitrust violations cannot obtain damages without showing that he actually paid more than he would have paid in the absence of the violation.” City of Pittsburgh v. West Penn Power Co., 147 F.3d 256, 265 (3d Cir. 1998) (citing Phillip E. Areeda & Herberet Hovenkamp, Antitrust Law, at 200 (1995)). Thus, “one pursuing antitrust recovery must establish that the damages suffered were caused by the defendant’s participation in a scheme repugnant to the antitrust laws.” In re Lower Lake Erie Iron Or. Antitrust Litig., 998 F.2d 1144, 1176 (3d Cir. 1993) (citing Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc., 429 U.S. 477 (1977)). “Once causation is determined, . . . the actual amount of damages may result from a reasonable estimate, as long as the jury verdict is not the product of speculation or guess work.” Id. at 1176 (internal quotation marks and quotations omitted).

         A challenge to causation is premature in a Daubert motion. “The standard for admitting expert testimony on antitrust damages is lower than a plaintiff’s burden of proof in establishing antitrust damages.” Linerboard, 497 F.Supp.2d at 675. As noted above, “Daubert does not require a plaintiff to prove causation of damages ‘twice-they do not have to demonstrate to the judge by a preponderance of the evidence that the assessments of their experts are correct, they only have to demonstrate by a preponderance of the evidence that their opinions are reliable’ and fit the facts of the case.” Id. at 675 (quoting Paoli, 35 F.3d at 744). As such, the failure of a plaintiff to adequately prove the causation theory on which the damages expert relies does not mean that the expert opinion is inadmissible under Daubert.

         This distinction was addressed in Stelwagon Manufacturing v. Tarmac Roofing Systems, Inc., 63 F.3d 1267 (3d Cir. 1995). There, the Third Circuit faced a similar causation challenge and agreed that plaintiff’s damages expert “failed to sufficiently link” any decline in the plaintiff’s sales to the alleged anticompetitive conduct. Id. at 1275. The Court found that while the expert’s opinions did not support a finding of actual damages, the district court properly rejected a challenge to the expert’s admissibility. Id.; see also Callahan v. A.E.V., Inc., 182 F.3d 237, 256 (3d Cir. 1999) (summarizing Stelwagon’s holding).

         Reviewing the admissibility of Dr. Lamb’s report under these standards, I find that his reliance on Plaintiffs’ causation theory does not render his report unreliable. Dr. Lamb explains that the entire “hard switch” campaign was a generic defense strategy launched by Reckitt in order to “prolong the life of the Suboxone franchise in the face of this expected generic competition.” (Lamb Report ¶ 71.) Dr. Lamb opines that Reckitt’s own November 2007 “Strategy Overview, ” regarding how to “fill the gap” in Suboxone net revenue expected to be caused by generic entry, described the strategy of launching a Suboxone film product in order to “[p]revent loss of brand share to generic.” (Lamb report ¶ 71 n.205.) He reasons that, as part of Reckitt’s hard switch scheme, Reckitt “planned to prepare the market generally, and MCOs in particular, for the eventual withdrawal of Suboxone tablets prior to its launch of Suboxone film, ” noting that Reckitt identified one of the “[c]ritical success factors” as an “[e]ffective tablet withdrawal communication strategy to pharmacists, patients, and physicians.” (Lamb Report ¶ 37.) Relying on this theory, Dr. Lamb then attributes damages to Reckitt’s alleged movement of the market from tablet to film, the effect of which continued after generic entry.

         Reckitt remains free to offer its countervailing view that “generics’ lagging share can be entirely explained by the fact that film was preferred by patients and doctors . . . and it was less expensive than the generic tablet entrants.” (Reckitt Reply Br. 6.) This argument, however, “implicates the weight a jury may give [Dr. Lamb’s report], not its admissibility.” In re Blood Reagents Antitrust Litig., No. 09-2081, 2015 WL 6123211, at *12 (E.D. Pa. Oct. 19, 2015). Accordingly, I will deny the Daubert motion on this ground.

         4. Whether Dr. Lamb’s Calculation of But-For Market Share is Arbitrary

         Reckitt’s next argument again attacks the viability of Dr. Lamb’s “Branch-Generic (Film)” damages calculation, which requires the calculation of actual and but for prices of the products at issue. Reckitt notes that Dr. Lamb measured the market share of Suboxone film but-for the allegedly anticompetitive conduct by averaging the market share gained by four “analog” comparator products. An analog or “yardstick” approach is where a model is constructed based upon analogous markets that are not subject to the anticompetitive conduct. See Castro v. Sanofi Pasteur, Inc., 134 F.Supp.3d 820, 838 (D.N.J. 2015). According to Reckitt, however, Dr. Lamb made no effort to determine whether the analogs were similar to each other or to Suboxone film in any metric that would successfully predict market share. In other words, Reckitt claims that Dr. Lamb failed to determine what factors tend to make a product line extension more or less successful, or to locate analogs that share significant characteristics with Suboxone film. Ultimately, Reckitt posits that Dr. Lamb’s assertion that film would have achieved less than half its actual share but for alleged anticompetitive conduct ignores evidence that film was simply a cheaper and preferred product.

         In response, Plaintiff explains that Dr. Lamb used analogs to estimate both the share of the Class’s purchases that would have been film and the share of the Class’s purchases that would have been tablets but for Reckitt’s hard switch scheme. In calculating these shares, Dr. Lamb identified drugs that could be used as analogs for Suboxone film. (Lamb Rebuttal Report ¶ 116.) To identify these analogs, Dr. Lamb used a set of objective selection criteria.[7] For each of the identified drugs, he calculated the percentage of the total share that the line extension captured thirty months and twenty-four months after the launch of the line extension, and then took the average across each of the drugs for the thirty-month time period and the twenty-four-month time period. (Lamb Rebuttal Report ¶ 119.) He then applied those percentages to the Suboxone line extension. (Id.)

         Such an analysis is a well-accepted scientific method and implicates no reliability concerns. “The before-and-after ‘yardstick’ methodology has been accepted by courts as a means to measuring damages in both indirect and direct purchaser actions.” In re Flonase Antitrust Litig., 284 F.R.D. 207, 232 (E.D. Pa. 2012); see also Nichols v. SmithKline Beecham Corp., No. 00-6222, 2003 WL 302352, at *4 (E.D. Pa. Jan. 29, 2003) (upholding expert’s use of benchmark at class certification stage as a “generally accepted methodology for determining impact”); In re Rubber Chems. Antitrust Litig., 232 F.R.D. 346, 354 (N.D. Cal. 2005) (noting that “yardstick” approach is a “reasonable and commonly-used approach”). The approach “is especially useful in cases where the pre-conspiracy prices are unreliable predictors of future prices–-that is, in cases where the before-and-after approach is unavailing. IIA Phillip E. Areeda et al., Antitrust Law ¶ 395b3 (3d ed. 2007). Nonetheless, “[i]t is also necessary that the yardstick market be as comparable as possible in all respects.” Id.

         “The selection of comparators will seldom approach the ‘Utopian ideal’ of identifying the perfect clone.” Celebrity Cruises Inc. v. Essef Corp., 434 F.Supp.2d 169, 189 (S.D.N.Y. 2006). “Arguments about what factors an expert should have controlled for in conducting a yardstick analysis generally go to the weight, rather than the admissibility, of the expert’s testimony.” Tawfilis v. Allergan, Inc., No. 15-307, 2017 WL 3084275, at *6 (C.D. Cal. June 26, 2017); see also In re Prograf, No. 2014 11-2242, WL 7641156, at *3 (D. Mass. Dec. 23, 2014) (same).[8]

         In short, Reckitt’s challenge to Dr. Lamb’s selection of analogs has no place in a Daubert analysis. To the extent Reckitt believes that Dr. Lamb’s methodology fails to adequately account for a range of factors that affect market shares, those issues are properly raised on cross-examination.

         5. Whether Dr. Lamb Failed to Account for Generic Bypass

         Reckitt’s final attack on Dr. Lamb’s expert report argues that he failed to account for generic bypass. Reckitt explains that while wholesalers’ customers, such as pharmacies and other retailers, tend to purchase the brand products exclusively from the wholesalers, many downstream customers prefer to buy their generic products directly from generic manufacturers, bypassing the wholesalers, i.e., generic bypass. Reckitt contends that this “generic bypass” phenomenon held true for buprenorphine products where the wholesaler members of the putative DPP class bought 100% of all branded Suboxone tablets, but they purchased less than half of all generic tablets. Reckitt contends that because Dr. Lamb did not make any adjustments to account for generic bypass, he improperly inflated the volume of purchases to the direct purchaser class and therefore inflated damages.

         “Generic bypass refers to the phenomenon in which retail pharmacies buy their brand drugs from wholesalers, . . . but purchase some or all of their generic drugs directly from generic manufacturers, thereby ‘bypassing’ the wholesaler. In such a situation, the wholesalers lose sales volume, and thus do not need to stock the generic drug at the same inventory level as the brand.” In re Neurontin Antitrust Litig., No. 02-1390, 2011 WL 286118, at *8 (D.N.J. Jan. 25, 2011); see also In re Wellbutrin XL Antitrust Litig., No. 08-2431, 2011 WL 3563385, at *15 (E.D. Pa. Aug. 11, 2011) (“Generic bypass refers to the situation whereby direct purchasers may lose sales volume because end purchasers often buy generics directly from the generic manufacturer and ‘cut out the middle man’ or ‘bypass’ the wholesaler.”) “At its most extreme, generic bypass may result in a wholesaler not making any purchases of the generic.” In re Neurontin, 2011 WL 286118, at *8.

         Repeatedly, courts have held that a generic bypass deduction need not be done at the class certification stage. Because the plaintiff’s burden at this stage is to demonstrate a reliable methodology to estimate class wide damages, deductions for generic bypass can be accomplished at later stages of the case. See, e.g., In re Loestrin 24 Fe Antitrust Litig., No. 13-2472, 2019 WL 3214257, at *6 (D.R.I. July 2, 2019) (declining, in a product hop antitrust case, to exclude expert for failing to account for generic bypass in damages analysis); In re Lidoderm Antitrust Litig., No. 14-2521, 2017 WL 679367, at *12 (N.D. Cal. Feb. 21, 2017) (finding that the expert’s failure to account for generic bypass did not impact the class certification analysis where the model could be adjusted to account for bypass); King Drug Co. of Florence, Inc. v. Cephalon, Inc., 309 F.R.D. 195, 209 (E.D. Pa. 2015) (“Insofar as Defendants argue that Plaintiffs’ damages calculations would vary based upon generic bypass, ‘[s]uch hypothetical conflicts regarding proof of damages are not sufficient to defeat class certification at this stage of the litigation.’”), vacated on other grounds, In re Modafinial Antitrust Litig., 837 F.3d 238 (3d Cir. 2016); In re Wellbutrin, 2011 WL 3563385, at *16 (finding that plaintiffs had adequately shown a reliable method to prove damages on a class-wide basis even though expert had not accounted for generic bypass); In re K-Dur Antitrust Litig., No. 01-1652, 2008 WL 2699390, at *15 (D.N.J. Apr. 15, 2008) (“Defendants’ arguments regarding the effects of generic bypass relate to the quantum of damages, rather than the fact of injury.”).

         Here, Dr. Lamb’s lack of accounting for generic bypass has no impact on either the admissibility of his report under Daubert or on whether damages can be proven with evidence common to the class. Moreover, in his rebuttal report, Dr. Lamb states that he “could apply the same damages methodology” as contained in his initial report and “simply adjust (reduce) purchase volumes to account for bypass. That is, [he] could simply reduce the Class’s share of the but-for volumes by the amount of the bypass (to account for volume that is purchased directly by entities that buy generic Suboxone tablets directly from manufacturers but are not Class members because they did not buy branded Suboxone tablets directly from Reckitt).” (Lamb Rebuttal Report ¶ 176.) As Dr. Lamb’s report offers a judicially-recognized method for calculating damages and has shown that the data needed to account for generic bypass is available and can be accommodated by the methodology, I decline to exclude his report on this basis.

         6. Conclusion as to Daubert Motion to Exclude Dr. Lamb’s Opinions

         In light of the foregoing, I will deny Reckitt’s Motion to Exclude Dr. Lamb in its entirety. The alleged deficiencies in Dr. Lamb’s report go not to its admissibility, but rather to its weight. Although Reckitt is free to raise such alleged problems during summary judgment briefing or at trial, they do not require exclusion of the report under Daubert.


         A. Standard of Review

         To obtain certification, a class must satisfy the requirements of Federal Rule of Civil Procedure 23(a) and 23(b). Rule 23(a) sets forth four prerequisites to class certification:

(1) the class is so numerous that joinder is impracticable;
(2) there are questions of law or fact common to ...

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