Pardi v. Tricida, Inc.

District Court, N.D. California·Decided October 10, 2024·No. 4:21-cv-00076·Unknown

Opinion

MICHAEL PARDI, et al., Case No. 21-cv-00076-HSG (LJC)

Plaintiffs, ORDER REGARDING DISCOVERY v. LETTER BRIEFS

TRICIDA, INC., et al., Re: Dkt. Nos. 166, 185 Defendants.

This case concerns allegations that misrepresentation by Defendant Gerrit Klaerner regarding FDA review of a pharmaceutical product called veverimer that Tricida, Inc. was developing affected the value of Tricida stock, including stock purchased by Lead Plaintiff Jeffrey Fiore. Klaerner was Tricida’s founder and CEO. Tricida was initially named as a defendant in this case, but Plaintiffs voluntarily dismissed their claims against Tricida when it entered bankruptcy proceedings. Judge Gilliam has referred all discovery disputes to the undersigned magistrate judge, and the parties have filed two joint letters regarding discovery disputes: a letter addressing several requests for production that Fiore served on Klaerner (ECF No. 166), and a letter addressing a subpoena that Fiore served on Tricida (ECF No. 185). For the reasons discussed below, the Court limits the scope of documents that Klaerner must produce in response to Fiore’s requests for production under Rule 34, but declines to limit the scope of Tricida’s production in response to Fiore’s subpoena, except to ensure that Klaerner will have an opportunity to screen that production for his own attorney-client communications. As Judge Gilliam recently explained in his Order granting class certification, “[t]wo such Defendant Klaerner’s failure to disclose issues flagged by the FDA at a May 1, 2020 meeting with Tricida” where the FDA allegedly raised concerns about “the magnitude and durability of the treatment effect,” the extent to which certain clinical data applied to the United States, and potentially outsized influence of a single site in Bulgaria. ECF No. 188 at 3. Judge Gilliam identified the two statements at issue as follows:

The first allegedly false and misleading statement was made during a May 7, 2020 earnings call in which Klaerner stated: In our late-cycle meeting with [the] FDA, we took the opportunity to address outstanding review issues. We presented our data and rationale as to why we think [veverimer] satisfied the requirements for initial approval under the Accelerated Approval Program, including the magnitude and durability of the treatment effect on the surrogate mark[er] serum bicarbonate demonstrated in the TRCA-301 and TRCA-301E trials. Id. ¶ 80. The Court held that Plaintiff adequately alleged that Klaerner misled investors by telling them about only one of two “outstanding review issues” discussed at the May 1 meeting: “the magnitude and durability of the treatment effect on the surrogate marker.” FAC Order at 22. The Court noted that “by disclosing this key detail, Klaerner was obligated to share the other significant review issue raised by the FDA—the ‘applicability of data from the TRCA-301 and TRCA-301E trials to the U.S. population’ discussed with the FDA.” Id. The second allegedly false and misleading statement was made during the same call. Klaerner stated:

In our late-cycle meeting with the FDA, held in May 2020, the FDA indicated it currently does not plan to hold an AdCom to discuss veverimer due in part to the logistical challenges posed by COVID-19. SAC ¶ 158. The Court held that Plaintiff adequately alleged that Klaerner intentionally or recklessly misrepresented the true reasons for the cancellation of the AdCom meeting because “‘[t]he FDA did not cite logistical challenges stemming from COVID-19 as even a contributing factor in canceling the AdCom meeting in its communications with Tricida.’” SAC Order at 17. The Court cited Plaintiff’s allegations that the FDA identified “‘significant issues” with the trial and their impact on a potential AdCom meeting” that would not “warrant convening an Advisory Committee.” Id. ECF No. 188 at 3–4 (alterations in original; footnote omitted). Judge Gilliam emphasized that omission of the FDA’s concern about a single site in issue of whether Tricida’s clinical data applied to the United States. ECF No. 188 at 16. “A fully corrective disclosure [would] have informed the market of the three substantive concerns raised by the FDA”: (1) magnitude and durability of the treatment effect; (2) application to the U.S. population and medical practice generally, given that most of the clinical data came from Eastern Europe; and (3) the influence of a single site in Bulgaria. Id. at 16–17. For the purpose of class certification, Judge Gilliam determined that a corrective disclosure on February 25, 2021 was the first to address all of those issues. Id. at 17. Judge Gilliam previously dismissed claims based on optimistic statements of opinion by Klaerner regarding the quality of Tricida’s data and the likelihood of FDA approval, ECF No. 145 at 10–16, as well as claims based on factual (and apparently accurate) statements regarding treatment data that did not reflect concerns raised by the FDA, id. at 18. Judge Gilliam dismissed claims based on statements that Tricida conducted trials in “Europe” (without specifying Eastern Europe), statements that did not discuss the location of clinical trials and spoke only generally about potential risk of the FDA denying approval, and statements that characterized the trials as “multicenter,” for failure to provide allegations raising a sufficient inference of scienter. Id. at 20– 23. A. Legal Standards for Discovery and Underlying Claims “Unless otherwise limited by court order,” Rule 26 of the Federal Rules of Civil Procedure provides that “[p]arties may obtain discovery regarding any nonprivileged matter that is relevant to any party’s claim or defense and proportional to the needs of the case, considering the importance of the issues at stake in the action, the amount in controversy, the parties’ relative access to relevant information, the parties’ resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit.” Fed. R. Civ. P. 26(b)(1) The elements of Fiore’s claims for securities fraud are: “(1) a material misrepresentation or omission by [Klaerner]; (2) scienter; (3) a connection between the misrepresentation or omission (5) economic loss; and (6) loss causation.” ECF No. 145 at 8 (quoting Macomb Cty. Emps. Ret. Sys. v. Align Tech., Inc., 39 F.4th 1092, 1098 (9th Cir. 2022)) (alteration in original). Scienter requires a showing of either “intent to deceive, manipulate, or defraud,” or “deliberate recklessness” where the “danger of misleading buyers or sellers . . . is either known to the defendant or is so obvious that the actor must have been aware of it.” Id. at 19 (quoting E. Ohman J:or Fonder AB v. NVIDIA Corp., 81 F.4th 918, 937 (9th Cir. 2023); Nguyen v. Endologix, Inc., 962 F.3d 405, 414 (9th Cir. 2020)). B. Document Requests at Issue “Plaintiff seeks to compel production of documents in response to RFP Nos. 2, 5, 7–12, 15–18, 21, 27-30, and 36–39.” ECF No. 166 at 1. The Court addresses those requests in the following categories: (1) requests regarding FDA proceedings, i.e., Request Nos. 11, 12, 15–17, 21, and 27–29; (2) requests related to stock sales, i.e., Request Nos. 7–10; (3) requests regarding communications with investors, analysts, and the press, i.e., Request Nos. 36–39; and (4) other miscellaneous requests, i.e

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