Dougherty v. Esperion Therapeutics, Inc.

District Court, E.D. Michigan·Decided November 19, 2020·No. 2:16-cv-10089·Unknown

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION

KEVIN L. DOUGHERTY, ET AL., Case No. 16-10089 Plaintiffs, SENIOR U.S. DISTRICT JUDGE v. ARTHUR J. TARNOW

ESPERION THERAPEUTICS, INC., ET AL., U.S. MAGISTRATE JUDGE R. STEVEN WHALEN Defendants. /

ORDER OVERRULING DEFENDANTS’ OBJECTIONS [159] AND ADOPTING MAGISTRATE JUDGE WHALEN’S REPORT & RECOMMENDATION [152]

This is a securities fraud case brought pursuant to sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (“SEA”), 15 U.S.C. §§ 78j(b), 78t(a), and Securities and Exchange Commission (“SEC”) Rule 10b-5, 17 C.F.R. § 240. On May 31, 2020, Magistrate Judge R. Steven Whalen granted Plaintiffs’ Motion for Class Certification and to Appoint Class Representatives and Class Counsel [66]. (ECF No. 152). On June 19, 2020, in response to a Joint Motion to Amend/Correct [154], Magistrate Judge Whalen issued a follow-up Order [157] designating the original Order [152] a Report and Recommendation (“R&R”) pursuant to 28 U.S.C. § 636(b)(1)(B). (ECF No. 157, PageID.7502). Defendants filed Objections to the R&R on July 6, 2020. (ECF No. 159). Plaintiffs responded on July 20, 2020. (ECF No. 161). Defendants filed a reply on July 27, 2020. (ECF No. 162). The Court heard arguments on October 6, 2020. For the reasons stated below, the Court OVERRULES Defendants’

Objections [159] and ADOPTS the R&R [152]. FACTUAL BACKGROUND Defendant, Esperion Therapeutics, Inc. (“Esperion”), is a pharmaceutical

company whose “sole focus is the development of ECT-1002, a first-in-class oral medication designed to lower LDL-cholesterol, also known as ‘bad cholesterol.’” Dougherty v. Esperion Therapeutics, Inc., 905 F.3d 971, 975 (6th Cir. 2018). “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.” (ECF No. 152, PageID.7462). “Plaintiffs, the purchasers of Esperion common stock between

August 18 and September 28, [2015,] brought this class action against Esperion and Mayleben for violating §§ 10(b) and 20(a) of the [SEA], as well as SEC Rule 10b- 5.” Dougherty, 905 F.3d at 977. The thrust of Plaintiffs’ claim is that, following an August 2015 meeting

between Esperion executives and FDA officials, Esperion and Mayleben made false statements about ETC-1002’s approval trajectory, misleading investors and “causing Esperion stock to trade at artificially inflated levels during the class period.” Id. at

976, 978. Specifically, Esperion issued a press release on August 17, 2015, stating 1) that “[t]he FDA [had] confirmed that LDL-C remain[ed] an acceptable clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-

1002 in patient populations [with HeFH or ASCVD],” and 2) that “[b]ased upon feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations [would] not require the completion of a cardiovascular outcomes trial.”

(ECF No. 152, PageID.7462). Additionally, in a conference call with market analysts that same day, Mayleben stated that “[ETC-]1002 will not require a CV outcomes trial to be completed prior to approval in patients with [HeFH] and ASCVD.” Dougherty, 905 F.3d at 976-77 (alterations in original).

As the Sixth Circuit noted in its order reversing this Court’s initial dismissal of Plaintiffs’ complaint: 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.

Id. at 976. The problem, however, was that the FDA’s minutes of the August 11, 2015 meeting—the official record—were contrary to Esperion’s and Mayleben’s

assertions. (ECF No. 152, PageID.7464). As Magistrate Judge Whalen explained: When the minutes were released [publicly], Esperion issued another press release . . . stating, contrary to its earlier position, that the “FDA ha[d] encouraged the Company to initiate a cardiovascular outcomes trial promptly . . . 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.

(Id.). Plaintiffs thus filed this suit for damages on January 12, 2016. (ECF No. 1). The Court appointed Ronald E. Wallace and Walter J. Minett as Lead Plaintiffs on April 5, 2016. (ECF No. 25). Plaintiffs amended their complaint on May 20, 2016, and on July 5, 2016, Defendants moved to dismiss. (ECF No. 29; ECF No. 30). On December 27, 2016, the Court granted Defendants Motion to Dismiss [30]. (ECF No. 38). The Sixth Circuit reversed on September 27, 2018 and remanded the case back to this Court. Daugherty, 905 F.3d at 984. LEGAL STANDARD Plaintiffs argue that “Defendants’ Objections simply regurgitate their class certification Opposition” and that, consequently, a “clear error” standard of review is appropriate. (ECF No. 161, PageID.7665). While it is true that “[a] district court need not provide de novo review where the objections are ‘frivolous, conclusive or

general,’” that exception does not apply here. Mira v. Marshall, 806 F.2d 636, 637 (6th Cir. 1986) (quoting Nettles v. Wainwright, 677 F.2d 404, 410 n.8 (5th Cir. 1982)). Defendants’ Objections each point to specific, allegedly defective, sections

of the R&R. Accordingly, the Court reviews them de novo pursuant to 28 U.S.C. § 636(b)(1). See, e.g., DiPonio Constr. Co. v. Int’l Union of Bricklayers & Allied Craftworkers, Local 9, 739 F. Supp. 2d 986, 992 (E.D. Mich. 2010). ANALYSIS

OBJECTION I: THE FRAUD-ON-THE MARKET PRESUMPTION OF RELIANCE DOES NOT APPLY BECAUSE PLAINTIFFS HAVE FAILED TO PROVE THAT THE MARKET FOR ESPERION STOCK WAS EFFICIENT DURING THE CLASS PERIOD.

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

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