Arthur J. Tarnow, Senior United States District Judge.
Before the Court is a securities fraud class action against Esperion, a clinical stage pharmaceutical company, and its Chief Executive Officer, Tim M. Mayleben. Plaintiffs, a class of investors who purchased Esperion common stock between August 18, 2015 and September 28, 2015, allege that Defendants violated §§ 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 promulgated thereunder. The underlying question that drives this dispute is whether FDA approval of ETC-1002, Esperion's lead product, requires Esperion to conduct a cardiovascular outcomes trial ("CVOT") to assess the drug's lipoprotein cholesterol-lowering efficacy in patients who suffer from certain types of cardiovascular problems.
Esperion allegedly made false statements to Plaintiffs about what occurred at an August 2015 meeting between Esperion and the U.S. Food and Drug Administration ("FDA"), and failed to disclose material facts about the development of ETC-1002, a medication designed to lower elevated levels of lipoprotein cholesterol ("LDL-C"). Esperion's deceit regarding its business, according to Plaintiffs, operated as a fraud and caused Plaintiffs to transact in Esperion common stock at artificially inflated prices. Essentially, "[h]ad Plaintiffs ... known the truth regarding the problems
Defendants argue that Plaintiffs' action is a "fraud by hindsight" case, exactly the
The Court will
Because Defendants move to dismiss Plaintiffs' complaint under Federal Rule of Civil Procedure 12(b)(6), the Court sets forth Plaintiffs' non-conclusory allegations as fact. See Ashcroft v. Iqbal, 556 U.S. 662, 677, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009); LULAC v. Bredesen, 500 F.3d 523, 527 (6th Cir. 2007) (explaining that the plaintiff's factual allegations, while "assumed to be true, must do more than create speculation or suspicion of a legally cognizable cause of action; they must show entitlement to relief) (emphasis in original)".
The FDA regulates drugs and the drug development process under the Federal Food, Drug, and Cosmetic Act ("FDCA"). Before a drug is marketed in the U.S., a drug sponsor, such as Esperion, must, among other things, complete nonclinical laboratory tests and submit a New Drug Application ("NDA") to the FDA. Navigating the approval process requires the expenditure of substantial time and financial resources. The process is often complex, expensive, and uncertain, and, depending on how the development of the product advances, may be subject to delays, limits, or changes.
In its short lifespan,
Esperion met with the FDA after completing Phase 2b clinical trials for ETC-1002 in August 2015. It subsequently issued a press release on August 17, 2015, in which it provided updates on the ETC-1002 development program. The press release contained the following relevant statements:
The final section of the press release informed readers that "[f]orward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including ... the risk that FDA may require additional studies or data prior to approval that might cause approval to be delayed." (Dkt. 30-5, Defs.' Ex. D at Pg. ID 640). It also stated: "Esperion may need to change the design of its Phase 3 program once final minutes from the FDA meeting are received." Id.
Esperion held a conference call and webcast with investors on August 17, after issuing the press release, to discuss the contents of the press release and Esperion's meeting with the FDA. In his opening remarks, CEO Mayleben confirmed that the FDA had determined that "LDL cholesterol lowering remains an acceptable clinical surrogate endpoint for the potential approval of a therapy such as 1002." (Dkt. 30-6, Defs.' Ex. E at Pg. ID 644). He also assured participants that the company's commitment to conducting a cardiovascular outcomes trial ... remains intact," both for commercial purposes and
Esperion received the FDA's End-of-Phase 2 final meeting minutes on September 28, 2015, and promptly issued a press release with an update on the ETC-1002 development program. Esperion declared "[the] FDA has
Esperion convened another conference call and webcast for investors later that day. CEO Mayleben began the call by telling participants that Esperion's "commitment to initiating a cardiovascular out-comes trial and having it well underway at the time of NDA submission remains intact." (Dkt. 30-8, Defs.' Ex. G at Pg. ID 663). Mayleben also cautioned,
Id. at Pg. ID 665.
In response to a question regarding the need for a completed cardiovascular out-comes trial prior to FDA approval, and the inconsistency in language between the two press releases, Mayleben explained, "we're trying to ... balance the ... history of using LDL-cholesterol as an accepted surrogate... with what the future may be given the fact that there are at least 4 CV outcomes trials ongoing now that will certainly read on whether LDL remains an accepted surrogate." Id. at Pg. ID 666. Mayleben also repeatedly emphasized that the development of ETC-1002 "is a very dynamic therapeutic area." Id. at Pg. ID 665.
The market reacted negatively in the days following Esperion's September 28 press release and conference call. The company's stock price fell from $35.09 per share to $18.33 per share; Plaintiffs say that this is a "one-day decline of 48% on massive volume of 9.9 million shares, or almost 8 times the average daily trading volume during the Class Period [August 18, 2015-September 28, 2015]." (Compl. at ¶ 52).
"To survive a motion to dismiss, [plaintiffs] must allege `enough facts to state a claim to relief that is plausible on its face.'" Traverse Bay Area Intermediate Sch. Dist. v. Mich. Dep't of Educ., 615 F.3d 622, 627 (6th Cir. 2010) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570,
"Section 10(b) of the Securities and Exchange Act ... and Rule 10b-5 prohibit fraudulent, material misstatements in connection with the sale or purchase of a security." Zaluski v. United Am. Healthcare Corp., 527 F.3d 564, 570 (6th Cir. 2008) (internal quotations omitted). Securities cases demand heightened pleading requirements. In order to state a claim for securities fraud under Section 10(b) of the Exchange Act and Rule 10b-5, a plaintiff must allege: "(1) a material misrepresentation or omission by the defendant; (2) scienter (3) a connection between the misrepresentation or omission and the purchase or sale of a security (4) reliance upon the misrepresentation or omission (5) economic loss and (6) loss causation." Ind. State Dist. Council of Laborers & Hod Carriers Pension and Welfare Fund v. Omnicare, Inc., 583 F.3d 935, 942 (6th Cir. 2009) (internal quotations omitted). Because § 10(b) claims involve fraud, the strict pleading requirements of Fed. R. Civ. P. 9(b) apply. The Sixth Circuit has stated that fraud must be plead with particularity, and that the complaint must "(1) specify the statements that the plaintiff contends were fraudulent (2) identify the speaker (3) state where and when the statements were made, and (4) explain why the statements were fraudulent." Id. at 942-43. Furthermore, a plaintiff must "specify each statement alleged to have been misleading" and "the reason or reasons why the statement is misleading." See 15 U.S.C. § 78u-4(b)(1). Plaintiff must also "state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind." See Konkol v. Diebold, Inc., 590 F.3d 390, 396 (6th Cir. 2009) (citing 15 U.S.C. § 78u-4(b)(2)).
Defendants set forth the following arguments in their Motion to Dismiss:
Both parties agrees that the PSLRA's heightened pleading standard governs this case. The Court will address each of Defendants' remaining arguments in turn.
Plaintiffs claiming a violation of the PSLRA "shall, with respect to each act or omission alleged ... state with particularity facts giving rise to a strong inference that the defendant acted with the required state of mind" in violating the securities laws. 15 U.S.C. § 78u-4(b)(2)(A); see also Tellabs, 551 U.S. at 314, 127 S.Ct. 2499. "A strong inference of scienter `must be more than merely plausible or reasonable — it must be cogent and at least as compelling as any opposing inference of non-fraudulent intent.'" Doshi v. General Cable Corp., 823 F.3d 1032, 1039 (6th Cir. 2016) (citing Tellabs, 551 U.S. at 314, 127 S.Ct. 2499). As the Tellabs Court advised, "[t]he strength of an inference cannot be decided in a vacuum. The inquiry is inherently comparative: How likely is it that one conclusion, as compared to others, follows from the underlying facts?" Tellabs, 551 U.S. at 323, 127 S.Ct. 2499. Courts evaluating a plaintiff's allegations of scienter
The Sixth Circuit has held that scienter includes a "knowing and deliberate intent to manipulate, deceive, or defraud, and recklessness." Ley v. Visteon Corp., 543 F.3d 801, 809 (6th Cir. 2008), abrogated on other grounds by Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 48-50, 131 S.Ct. 1309, 179 L.Ed.2d 398 (2011). "Recklessness is ... highly unreasonable conduct which is an extreme departure from the standards of ordinary care" and requires more than negligence; it is "akin to conscious disregard." Frank, 646 F.3d at 959. "Before drawing an inference of recklessness, courts typically require `multiple, obvious red flags,' demonstrating `an egregious refusal to see the obvious, or to investigate the doubtful.'" Doshi, 823 F.3d at 1039 (quoting PR Diamonds, Inc. v. Chandler, 364 F.3d 671, 686-87, 695 (6th Cir. 2004), abrogated on other grounds by Matrixx, 563 U.S. at 48-50, 131 S.Ct. 1309)).
Courts in this circuit use nine factors to holistically review a plaintiff's allegations for securities fraud:
Helwig v. Vencor, Inc., 251 F.3d 540, 552 (6th Cir. 2001) (en banc). This list is not intended to be exhaustive, but rather is helpful in evaluating the sufficiency of securities fraud pleadings. Id. Moreover, the fact that Plaintiff does not mention allegations with respect to all nine of the Helwig factors is not dispositive. See, e.g., City of Monroe Emps. Ret. Sys. v. Bridgestone Corp., 399 F.3d 651, 684-86 (6th Cir. 2005); In Re Hayes Lemmerz Int'l, Inc. Equity Sec. Litig., 271 F.Supp.2d 1007, 1014-17 (E.D. Mich. 2003).
Kuyat v. BioMimetic Therapeutics, Inc., a similar Sixth Circuit case from 2014, is on point. There, the plaintiffs alleged that Defendant BioMimetic made materially false statements when it spoke optimistically about FDA-approval prospects for its lead product, Augment, even though the company knew of multiple deficiencies in Augment's clinical trials. 747 F.3d 435, 440 (6th Cir. 2014). They further argued "that the FDA had privately communicated that it expected BioMimetic to obtain statistically significant results based on an analysis of the ITT [intent-to-treat] population, but that the company characterized those results as less important than the analysis of the mITT [modified-intent-to-treat] population." Id. at 441. The plaintiffs identified numerous statements made by the company that shed a favorable light on Augment's clinical trials; the company told investors that it "characterized the study as producing positive top line results," for
The Sixth Circuit concluded that the plaintiffs' allegations did not give rise to a strong inference of scienter. A holistic review of the pleadings convinced the court that "a reasonable person would conclude that the inference of scienter in this case is not as strong as the opposing inference. BioMimetic could legitimately believe that the ... results it achieved based on an analysis of the mITT population would be sufficient to obtain approval by the FDA." Id. The court found that the May 2007 and September 2010 letters, upon which the plaintiffs relied, were simply ambiguous rather than fraudulent, and that "nothing in [either letter] indicates that the FDA told BioMimetic to use an ITT population for the primary effectiveness analysis." Id. at 442. Furthermore, the court held, "the complaint did `not allege any facts showing that,
Likewise, here, Plaintiffs have not adequately pled a strong inference of scienter because they have not alleged with particularity facts showing what Esperion and/or Mayleben did or did not know on August 17, 2015, when the allegedly misleading statements were made. Plaintiffs have neither pointed to anything in the record to suggest that Esperion or Mayleben knew that they were mistaken in their August 17 communications, nor have they identified facts demonstrating that Esperion actually understood the FDA's communications in a way that was different than what was publicly disclosed.
Plaintiffs argue that even if Defendants did not operate with a knowing and deliberate intent to defraud, their actions constituted "absolute recklessness." (Mot. Hr'g Tr. 35). The Court disagrees. Defendants' statements were made based on their knowledge that the FDA has never before required a company seeking approval of a drug that claims to lower cholesterol levels to conduct a CVOT. (Dkt. 30-4, Defs.' Ex. C, at Pg. ID 637). That Defendants did not accurately predict that the FDA would deviate from its normal practices with respect to the need to conduct a CVOT for this purpose hardly constitutes an "egregious refusal to see the obvious, or to investigate the doubtful." PR Diamonds, Inc., 364 F.3d at 693. Additionally, although Esperion may have ultimately been mistaken about the scope of the CVOT — in terms of whether the trials were necessary to measure ETC-1002's ability as to both lowering cholesterol levels and improving overall heart health — "there are no facts suggesting the company knew this at the time its representatives spoke." Kuyat, 747 F.3d at 442. Defendants did not engage in such "highly unreasonable conduct which an extreme departure from the standards of ordinary care." PR Diamonds, Inc., 364 F.3d at 681. Moreover, the Court finds that "[i]t is hard to imagine that [Defendants] would risk the [FDA's] ire" by lying about the steps in the development process with which it was required to comply. Kuyat, 747 F.3d at 442.
Plaintiffs seeking recovery under § 10(b) and Rule 10b-5 must show both an omission or misstatement and its materiality. A misrepresentation or omission is material if there is a "substantial likelihood that the disclosure of the omitted fact would have been viewed by a reasonable investor as having significantly altered the total mix of information made available." See Basic, Inc. v. Levinson, 485 U.S. 224, 231-32, 108 S.Ct. 978, 99 L.Ed.2d 194 (1988). The Sixth Circuit has said that when a company speaks, it must "provide complete and non-misleading information." Omnicare, Inc., 583 F.3d at 943; see also Rubin v. Schottenstein, Zox & Dunn, 143 F.3d 263, 268 (6th Cir. 1998). It is important to recognize, though, that "liability does not attach to mere corporate puffery or statements of corporate optimism." Omnicare, Inc., 583 F.3d at 943. Moreover, there is a safe-harbor that excuses liability for specific statements made by a defendant, including "projections, statements of plans and objectives, and estimates of future economic performance." Helwig, 251 F.3d at 547-48 (citing 15 U.S.C. § 78u-5(i)(1)). A plaintiff may defeat the safe-harbor only "if the statement was material; if defendants had actual knowledge that it was false or misleading; and if the statement was not identified as `forward-looking' or lacked meaningful cautionary statements." Helwig, 251 F.3d at 548 (citing 15 U.S.C. § 78u-5(c)(1)).
Plaintiffs claim that Defendants' August 17, 2015 statements were false or misleading, and that there are material differences between the August 17 and the September 28 statements. Plaintiffs first point to Esperion's August 17 press release, which states:
In the following sentence, Esperion indicates:
Esperion set forth two goals: the first and primary goal was to obtain FDA approval for ETC-1002 as a drug that effectively lowers LDL cholesterol. The second, broader goal, that would hopefully occur at a later stage of development, was to seek FDA approval for ETC-1002 as a drug that can reduce the likelihood of heart disease and improve heart health overall. (Mot. Hr'g Tr. 6-7).
Plaintiffs note that during the August 17 conference call, Defendant Mayleben "made it clear that based on the information from the FDA, the Company had `a clear regulatory path forward' for ETC-1002 use with HeFH and ASCVD patients,'" meaning that completing a CVOT to assess ETC-1002's LDL-cholesterol lowering abilities was unnecessary. (Dkt. 32, Pls.' Br. at Pg. ID 713). This is true: Mayleben told investors on the call that:
(Dkt. 30-6, Defs.' Ex. E at Pg. ID 645).
Mayleben also said:
Id. (emphasis added).
Mayleben's comments during the August conference call suggest two things: first, that it was Esperion's understanding that it would not be required by the FDA to complete a CVOT prior to approval in HeFH and ASCVD patients as to the drug's ability to lower LDL-C levels; and second, that Esperion still intended, at some point, to initiate a CVOT to determine whether ETC-1002 could be used to improve an individual's overall heart health and reduce the risk of cardiovascular disease. Mayleben also emphasized to participants that Esperion expected "to
Esperion followed up on its prior statements regarding the development of ETC-1002 on September 28, 2015, after receiving the final meeting minutes from the FDA. Plaintiffs argue that it was at this time that they discovered that Defendants' earlier statements were false and misleading. In its press release, Esperion declared that the "FDA encouraged the Company to
Id.
Plaintiffs argue that Defendants made false and misleading statements and omissions "by representing the future prospects for Esperion's drug ETC-1002 and engaging in a scheme to deceive the market." (Compl. ¶ 53). The Court finds no evidence supporting Plaintiffs' claims. It is certainly true that on August 17, Esperion represented that FDA approval of ETC-1002, as to its effectiveness in lowering levels of LDL-C in HeFH and ASCVD patient populations specifically, would not require the completion of a CV outcomes trial, and that on September 28, Esperion said that the FDA was in fact interested in getting a CVOT underway. See Dkt. 30-5, Defs.' Ex. D at Pg. ID 639; Dkt. 30-6, Ex. E at Pg. ID 645; Dkt. 30-8, Ex. G at Pg. ID 663. It is also true, however, that throughout the class period,
The fact that Esperion consistently communicated the risks of drug development and the inherently dynamic nature of the FDA approval process is also worthy of mention. Both the August and September press releases include the following language: "This press release contains forward-looking statements that are made pursuant to the safe-harbor provisions of the federal securities laws ...
Plaintiffs' arguments are unavailing. They have not set forth sufficient evidence to bypass the protection of the safe harbor provision. In addition to the fact that these statements are protected and non-actionable, Plaintiffs have failed to show that the defendants had actual knowledge that these statements were false or misleading. See Omnicare, Inc., 583 F.3d at 943.
Section 20(a) of the 1934 Act states:
15 U.S.C. § 78t(a) (2006). "Section 20(a) claims are predicated upon at least one underlying violation committed by a controlled party." Ley, 543 F.3d at 818. Moreover, "[w]hen a primary violation of securities law is shown, that provision imposes joint and several liability on `controlling persons.'" Omnicare, Inc., 583 F.3d at 948.
Because the Court will
Accordingly,