Dougherty v. Esperion Therapeutics, Inc.

CourtDistrict Court, E.D. Michigan
DecidedMay 31, 2020
Docket2:16-cv-10089
StatusUnknown

This text of Dougherty v. Esperion Therapeutics, Inc. (Dougherty v. Esperion Therapeutics, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Michigan primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Dougherty v. Esperion Therapeutics, Inc., (E.D. Mich. 2020).

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION KEVIN L. DOUGHERTY, ET AL., Plaintiffs, No. 16-10089 v. District Judge Arthur J. Tarnow Magistrate Judge R. Steven Whalen ESPERION THERAPEUTICS, INC., ET AL., Defendants. / OPINION AND ORDER GRANTING CLASS CERTIFICATION AND APPOINTING CLASS REPRESENTATIVES AND CLASS COUNSEL This is a securities fraud case brought under Sections 10(b) and 20(a) of the Securities Exchange Act, 15 U.S.C. §§ 78j(b) and 78t(a), and Securities and Exchange Commission (“SEC”) Rule 10b-5, 17 C.F.R. § 240.10b-5. Before the Court is Plaintiffs’ Motion for Class Certification, and to Appoint Class Representatives and Class Counsel [ECF No. 66], which has been referred for hearing and determination under 28 U.S.C. § 636(b)(1)(A). Plaintiffs define the proposed class as follows: “All persons who purchased or otherwise acquired the common stock of Esperion Therapeutics, Inc. between August 18, 2015 and September 28, 2015 (inclusive) and were damaged thereby. Excluded from the Class are the Defendants; the officers and directors of the Company; memebers of their immediate families, their legal rpresentatives; their heirs, successors or assigns; and any entity in which Defendants have or had a controlling interest.” For the reasons discussed below, the motion will be GRANTED. I. BACKGROUND Defendant Esperion Therapeutics, Inc. (“Esperion”) is a pharmaceutical company -1- that was engaged in the development of ETC-1002, a drug aimed at lowering high- density-lipoprotein cholesterol. Defendant Tim M. Mayleben is Esperion’s CEO and a member of its Board of Directors. As such, he was heavily involved in Esperion’s efforts to secure Food and Drug Administration (“FDA”) approval for ETC-1002.1 An important factor in determining the likelihood and time line for FDA approval was whether the FDA would require a cardiovascular outcomes trial (“CVOT”), a lengthy and costly study. On August 11, 2015, Esperion had an End of Phase 2 Meeting (“EOP2 Meeting”) with the FDA. Six days later, on August 17, 2015 Esperion published a press release containing the following two statements: "The FDA confirmed that LDL-C remains an acceptable clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patient populations who have a high unmet medical need, including patients with [HeFH] ... or [ASCVD]." “Based upon feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations will not require the completion of a cardiovascular outcomes trial.” In its opinion reversing this Court’s dismissal of the complaint2, the Sixth Circuit 1 In N.J. Carpenters Pension & Annuity Funds v. Biogen IDEC Inc., 537 F.3d 35, 39 (1st Cir. 2008), the Court described the FDA’s clinical trial process: “If approved by the FDA, human clinical trials proceed in three phases: Phase I studies generally involve twenty to eighty subjects, and are designed to determine how the drug works in humans and the side effects associated with increasing doses. [21 C.F.R.] § 312.21(a)(1). Phase II studies usually involve no more than several hundred subjects, and are designed to evaluate the effectiveness of the drug, as well as common short-term side effects and risks. Id. § 312.21(b). Phase III studies are large-scale trials, usually involving several hundred to several thousand subjects, and are intended to gather the information necessary to provide an adequate basis for labeling the drug. Id. § 312.21(c).... After Phase III, the FDA considers the results of all of the clinical trials in determining whether to approve a drug for market. See id. §§ 314.125(b), 314.126(a).” 2 The Sixth Circuit held that this Court erred in finding that Plaintiffs had failed to show the element of scienter. -2- explained the import of Esperion’s public statements: “These statements require some explanation to be fully understood in context. A cardiovascular outcomes trial (CVOT) is a costly, lengthy study that measures a drug's effectiveness in reducing cardiovascular risk over several years. Because lower LDL-cholesterol is presumed to improve overall heart health, the FDA does not typically require companies seeking approval of a new cholesterol-lowering drug to complete a CVOT and prove that the drug actually reduces cardiovascular risk. Instead, the FDA treats LDL-cholesterol as a “surrogate endpoint,” or proxy, for cardiovascular risk. In other words, if a new drug is shown to lower LDL-cholesterol, the FDA assumes that it also improves overall cardiovascular health. By saying that the FDA would continue to use LDL-cholesterol as a proxy for cardiovascular risk, and that the FDA would not require a completed CVOT prior to approving ETC-1002, Esperion was essentially telling its investors that ETC-1002 had a clear path to regulatory approval.” Dougherty v. Esperion Therapeutics, Inc., 905 F.3d 971, 976 (6th Cir. 2018). (Emphasis added). Following this press release, Defendant Mayleben participated in a conference call with market analysts. In that call, he reiterated that the FDA would not require a CVOT in target populations. The Sixth Circuit described Mayleben’s statements: “In a follow-up conference call with market analysts, CEO Tim Mayleben stated that Esperion issued the release ‘because we felt that some of the information we learned last week at our End-of-Phase II meeting about the regulatory path forward for [ETC-]1002 was important for you to know sooner rather than later, even *977 though we don't yet have meeting minutes back from the FDA.’ Regarding the possibility of a CVOT, Mayleben said that ‘[w]e know that [ETC-]1002 will not require a CV outcomes trial to be completed prior to approval in patients with heterozygous FH and ASCVD, those patient populations that the FDA considers to have an appropriate benefit/risk ratio.’ Thus, Mayleben confirmed what Esperion had stated in its earlier press release—the company believed the FDA would not require a completed CVOT prior to approval of ETC-1002 for use in patients whose high cholesterol could not be managed using statins alone. However, Mayleben indicated that the company still intended to conduct a CVOT at some point, in hopes that the FDA would later approve ETC-1002 for broader use in patients seeking an overall reduction in the risk of cardiovascular disease.” -3- Dougherty, 905 F.3d at 976–77. (Emphasis added).3 However, the FDA’s final minutes of the EOP2 Meeting were at odds with Esperion’s press release and Mayleben’s statements to the market analysts regarding the necessity of a CVOT. When the minutes were released, Esperion issued another press release on September 28, 2015, stating, contrary to its earlier position, that the “FDA has encouraged the Company to initiate a cardiovascular outcomes trial promptly, which would be well underway at the time of the New Drug Application submission and review, since any concern regarding the benefit/risk assessment of ETC-1002 could necessitate a completed cardiovascular outcomes trial before approval.” In a subsequent conference call, Mayleben characterized Esperion’s latest press release as “slightly different” than the language used in the August release. As the Sixth Circuit observed, “Market analysts seized on this change in position, and Esperion’s stock dropped 48% the next day, from $35.09 per share to $18.33 per share.” Dougherty, 905 F.3d at 977.

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Dougherty v. Esperion Therapeutics, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/dougherty-v-esperion-therapeutics-inc-mied-2020.