Sneed Jr. v. AcelRx Pharmaceuticals, Inc.

CourtDistrict Court, N.D. California
DecidedSeptember 28, 2022
Docket5:21-cv-04353
StatusUnknown

This text of Sneed Jr. v. AcelRx Pharmaceuticals, Inc. (Sneed Jr. v. AcelRx Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sneed Jr. v. AcelRx Pharmaceuticals, Inc., (N.D. Cal. 2022).

Opinion

1 2 3 UNITED STATES DISTRICT COURT 4 NORTHERN DISTRICT OF CALIFORNIA 5 SAN JOSE DIVISION 6 7 AARON SNEED JR., Case No. 21-cv-04353-BLF

8 Plaintiff, ORDER GRANTING MOTION TO 9 v. DISMISS WITH LEAVE TO AMEND

10 ACELRX PHARMACEUTICALS, INC., et [Re: ECF No. 57] al., 11 Defendants. 12 13 Now before the Court is Defendants’ Motion to Dismiss this putative securities class 14 action. MTD, ECF No. 57. Plaintiffs oppose the Motion. Opp., ECF No. 63. For the reasons 15 discussed at the September 1, 2022 motion hearing and further explained below, the Court 16 GRANTS Defendants’ Motion to Dismiss WITH LEAVE TO AMEND. 17 I. BACKGROUND 18 On June 8, 2021, Plaintiff Aaron Sneed Jr. filed a securities class action suit in this Court 19 alleging violations of various securities laws by AcelRx Pharmaceuticals, Inc. (“AcelRx”), AcelRx 20 Chief Executive Officer Vincent J. Angotti, and AcelRx Chief Financial Officer Raffi Asadorian. 21 Complaint, ECF No. 1. The Court appointed Aaron Sneed Jr. and Yaacov Musry as co-lead 22 plaintiffs and Pomerantz LLP as lead counsel. ECF No. 47. 23 On March 3, 2022, Plaintiffs filed an amended complaint. FAC, ECF No. 54. The FAC 24 adds one additional Defendant, AcelRx Chief Health Officer Pamela Palmer. Id. Plaintiffs assert 25 four counts under the Securities and Exchange Act of 1934 (“Exchange Act”) on behalf of a class 26 including all individuals who purchased or otherwise acquired AcelRx securities (ticker symbol 27 ACRX) between March 20, 2019 and February 12, 2021. Id. ¶ 1. 1 pain. Id. ¶ 32. DSUVIA, the product at the center of this suit, is an opioid painkiller that is 2 administered sublingually, and therefore particularly useful in circumstances where patients 3 cannot swallow oral medication and access to intravenous pain relief is not possible. Id. ¶¶ 32-33. 4 In November 2018, the U.S. Food and Drug Administration (“FDA”) approved AcelRx’s 5 application for DSUVIA. Id. ¶ 54. In so doing, the FDA also approved the DSUVIA Risk 6 Evaluation and Mitigation Strategy (“REMS”), which is “a drug safety program that the [FDA] 7 can require for certain medications with serious safety concerns to help ensure the benefits of the 8 medication outweigh its risks.” Id. ¶¶ 35, 54. As an FDA-approved drug, DSUVIA is subject to 9 the Federal Food, Drug, and Cosmetic Act (“FDCA”), which prohibits the introduction into 10 interstate commerce of any drug that is “misbranded.” Id. ¶ 7, 85; see 21 U.S.C. § 331. 11 On February 11, 2021, AcelRx received a warning letter from the FDA (“Warning Letter”) 12 indicating that two of AcelRx’s promotional materials—a banner advertisement and a tabletop 13 display—made “false or misleading claims and representations about the risks and efficacy of 14 DSUVIA” and therefore violated the FDCA. Id. ¶ 15. After AcelRx publicly disclosed this letter 15 on February 16, 2021, the stock price fell $0.21 per share, or 8.37%. Id. ¶ 18. Plaintiffs allege 16 that “Defendants made materially false and misleading statements regarding the Company’s 17 business, operations, and compliance policies.” Id. ¶ 14. Plaintiffs point to the Warning Letter in 18 claiming that Defendants made false and/or misleading statements or failed to disclose information 19 indicating that “(1) AcelRx failed to implement and/or maintain sufficient disclosure controls and 20 procedures regarding the marketing of DSUVIA; (2) as a result, the Company engaged in the 21 Misbranding Violations; and (3) the Company was therefore subject to increased risk of regulatory 22 investigations or enforcement actions.” Id. Plaintiffs also assert that Defendants engaged in a 23 scheme to market DSUVIA beyond its permitted label. Id. ¶ 13. Finally, Plaintiffs claim that the 24 individual Defendants engaged in insider trading by selling shares of the stock after receiving the 25 Warning Letter but before disclosing it to the public. Id. ¶ 18. 26 II. LEGAL STANDARD 27 “A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) for failure to state a 1 Force v. Salazar, 646 F.3d 1240, 1241–42 (9th Cir. 2011) (quoting Navarro v. Block, 250 F.3d 2 729, 732 (9th Cir. 2001)). When determining whether a claim has been stated, the Court accepts 3 as true all well-pled factual allegations and construes them in the light most favorable to the 4 plaintiff. Reese v. BP Expl. (Alaska) Inc., 643 F.3d 681, 690 (9th Cir. 2011). But the Court need 5 not “accept as true allegations that contradict matters properly subject to judicial notice” or 6 “allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable 7 inferences.” In re Gilead Scis. Sec. Litig., 536 F.3d 1049, 1055 (9th Cir. 2008) (internal quotation 8 marks and citations omitted). While a complaint need not contain detailed factual allegations, it 9 “must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible 10 on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 11 550 U.S. 544, 570 (2007)). A claim is facially plausible when it “allows the court to draw the 12 reasonable inference that the defendant is liable for the misconduct alleged.” Id. 13 In addition to the pleading standards discussed above, a plaintiff asserting a private 14 securities fraud action must meet the heightened pleading requirements imposed by Federal Rule 15 of Civil Procedure 9(b) and the Private Securities Litigation Reform Act of 1995 (“PSLRA”). In 16 re VeriFone Holdings, Inc. Sec. Litig., 704 F.3d 694, 701 (9th Cir. 2012). Rule 9(b) requires a 17 plaintiff to “state with particularity the circumstances constituting fraud . . . .” Fed. R. Civ. P. 9(b); 18 see also In re VeriFone Holdings, 704 F.3d at 701. Similarly, the PSLRA requires that “the 19 complaint shall specify each statement alleged to have been misleading, [and] the reason or 20 reasons why the statement is misleading . . . .” 15 U.S.C. § 78u-4(b)(1)(B). The PSLRA further 21 requires that the complaint “state with particularity facts giving rise to a strong inference that the 22 defendant acted with the required state of mind.” Id. § 78u-4(b)(2)(A). “To satisfy the requisite 23 state of mind element, a complaint must allege that the defendant[] made false or misleading 24 statements either intentionally or with deliberate recklessness.” In re VeriFone Holdings, 704 25 F.3d at 701 (internal quotation marks and citation omitted) (alteration in original). The scienter 26 allegations must give rise not only to a plausible inference of scienter, but to an inference of 27 scienter that is “cogent and at least as compelling as any opposing inference of nonfraudulent III. REQUEST FOR JUDICIAL NOTICE 1 Ordinarily, a district court's inquiry on a Rule 12(b)(6) motion to dismiss is limited to the 2 pleadings.

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Sneed Jr. v. AcelRx Pharmaceuticals, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/sneed-jr-v-acelrx-pharmaceuticals-inc-cand-2022.