ORDER
(1) DENYING LEAD PLAINTIFF'S MOTION TO COMPEL
AND
(2) GRANTING DEFENDANTS' MOTION TO COMPEL
[ECF Nos. 113, 117]
BARBARA L. MAJOR, Magistrate Judge.
Currently before the Court is Lead Plaintiff's "Motion to Compel" [ECF No. 117-1 ("Pl.'s MTC")], Defendants' "Motion to Compel Response to Interrogatory No. 8 Relating to Confidential Witnesses" [ECF No. 113-1 ("Defs.' MTC")], Defendants' opposition to Lead Plaintiff's motion [ECF No. 120 ("Defs.' Oppo.")], and Lead Plaintiff's opposition to Defendants' motion [ECF No. 121 ("Pl.'s Oppo.")]. For the reasons set forth below, Lead Plaintiff's motion is DENIED and Defendants' motion is GRANTED.
FACTUAL BACKGROUND
The facts set forth are taken from the Consolidated Amended Class Action Complaint [ECF No. 43 ("Compl.")] and Second Amended Complaint [ECF No. 59 ("SAC")] or documents incorporated therein. The Consolidated Amended Class Action Complaint and the SAC allege that Arena Pharmaceuticals, Inc. ("Arena") and its senior executives violated Section 10(b) and 20(a) of the Securities and Exchange Act of 1934 ("Exchange Act") and Rule 10b-5 promulgated thereunder by making materially false statements and/or omitting to disclose material facts concerning the safety and the completeness of the data needed for the U.S. Food and Drug Administration's ("FDA") approval of Arena's developmental weight loss drug, Lorcaserin.1 Compl.; SAC; see also Schueneman v. Arena Pharms., Inc., 840 F.3d 698, 709 (9th Cir. 2016) (finding that Lead Plaintiff's theory is that "Defendants intentionally withheld information material to the market's assessment of whether and when the FDA would likely approve [L]orcaserin").
To obtain FDA approval to market Lorcaserin, Arena had to demonstrate Lorcaserin's safety and efficacy based on non-clinical/pre-clinical animal studies and clinical trials on humans. Compl. at 12-13. As part of Lorcaserin's new drug application to the FDA, Arena was required to conduct a long-term study of the potential carcinogenesis on rats ("Rat Study"). Id. at 14. The Rat Study was a two-year non-clinical/pre-clinical carcinogenicity study on rats that began in 2007 and was designed to approximate a lifetime of human use and to assess the risk to humans. SAC at 5, 17.
By February 2007, the Rat Study indicated that Lorcaserin caused mammary, brain, skin, and nerve-sheath tumors, including lethal, malignant mammary and brain tumors. Id. at 6. In September 2007, the FDA told Arena it was concerned that the Rat Study data reflected potential effects in humans and that Arena needed to dispel this concern with data on animals and humans exposed to Lorcaserin. ECF No. 61-5 at 7, Exhibit D.
In April 2008, the FDA and Arena representatives met to discuss the causes of mammary tumors in rats and the FDA's concern about the tumors' significance to humans. ECF No. 61-5 at 8. The FDA approved Arena's written warning to humans in the clinical trials and told Arena that animal mechanistic studies and continued clinical studies of humans exposed to Lorcaserin could dispel its concern about the Rat Study data. Id. At that time, Arena representatives hypothesized that the tumors were attributable to a rodent-specific mechanism. Id. The FDA did not halt Lorcaserin's ongoing human clinical trials, but did request bi-monthly updates. SAC at 7-9, 18-20.
Arena provided the bi-monthly updates until completion of the Rat Study and submission of the draft report on the Rat Study to the FDA on February 3, 2009. ECF No. 61-4 at 14, Exhibit C. Arena's bi-monthly updates included "initial reads" of data that were not reviewed by outside pathologists. Compl. at 20-22. The Rat Study concluded that "breast tumors developed at all doses, and that Lorcaserin caused brain tumors as well as many other malignant tumors." SAC at 9, 22. Arena's final report to the FDA included a peer-reviewed analysis by "three [non-Arena] veterinary pathologists" who concluded there were fewer malignant tumors than Arena initially reported to the FDA, but there was an "apparent increase in aggressiveness of adenocarcinoma in rats administered Lorcaserin." Compl. at 5, 8. Plaintiffs allege that the data submitted to the FDA failed to show that the results of the Rat Study were irrelevant to humans. SAC at 22.
In December 2009, Defendants filed Lorcaserin's New Drug Application ("NDA") and the FDA appointed the Advisory Committee, comprised of physicians and scientists, to discuss and vote on whether to recommend FDA approval for Lorcaserin. Compl. at 7. The Advisory Committee was scheduled to meet on September 16, 2010. Id. Investors first learned about the Rat Study data in September 2010, when the Advisory Committee voted 9-5 against recommending approval for Lorcaserin. Id. at 6-8.
In October 2010, Arena publicly disclosed that the FDA completed its review of the NDA and found that it could not approve the NDA "in its present form" because it failed to demonstrate that the Rat Study was irrelevant to humans. Id. at 19-22.
Plaintiffs allege that Defendants knew by the beginning of the Class Period (March 17, 2008 through January 27, 2011) that the Rat Study indicated that Lorcaserin caused cancer and yet failed to disclose that information to investors. Compl. at 14. Plaintiffs further allege that the negative results of the Rat Study and the FDA's concerns over the data constituted material facts that should have been, but were not, disclosed to investors and that instead of disclosing this information, Defendants repeatedly falsely represented that Lorcaserin was safe and made materially false and misleading representations about non-clinical study results. Id. at 54-55. Additionally, Plaintiffs allege that when the misrepresentations were disclosed and became apparent on the market, Arena's securities declined precipitously. Id. Plaintiffs allege that as a result of their purchases of Arena securities during the Class Period, they suffered economic loss. Id.
LEGAL STANDARD
The scope of discovery under the Federal Rules of Civil Procedure is defined as follows: Parties 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 discovery in resolving issues, and whether the burden or expense of the proposed discovery outweighs the likely benefit. Information within this scope of discovery need not be admissible in evidence to be discoverable.2
Fed. R. Civ. P. 26(b)(1).
District courts have broad discretion to determine relevancy for discovery purposes. See Hallet v. Morgan, 296 F.3d 732, 751 (9th Cir. 2002). District courts also have broad discretion to limit discovery to prevent abuse. See Fed. R. Civ. P. 26(b)(2) (instructing that courts must limit discovery where the party seeking the discovery "has had ample opportunity to obtain the information by discovery in the action" or where the proposed discovery is "unreasonably cumulative or duplicative," "obtain[able] from some other source that is more convenient, less burdensome, or less expensive," or where it "is outside the scope permitted by Rule 26(b)(1)").
Pursuant to Federal Rule of Civil Procedure 37, "a party may move for an order compelling disclosure of discovery." Fed. R. Civ. P. 37(a)(1). The party seeking to compel discovery has the burden of establishing that its request satisfies the requirements of Rule 26. Soto v. City of Concord, 162 F.R.D. 603, 610 (N.D. Cal. July 17, 1995). Thereafter, the party opposing discovery has the burden of showing that the discovery should be prohibited, and the burden on "clarifying, explaining, and supporting its objections." DIRECTV, Inc. v. Trone, 209 F.R.D. 455, 458 (C.D. Cal. 2002) (citing Blankenship v. Hearst Corp., 519 F.2d 418, 429 (9th Cir. 1975)).
DISCUSSION
The Court will first address Lead Plaintiff's motion to compel the production of documents responsive to requests 34-37. Then, the Court will address Defendants' motion to compel a response to Interrogatory Number 8.
A. LEAD PLAINTIFF'S MOTION TO COMPEL
The documents at issue concern Arena's application to market Lorcaserin in the European Union. Pl.'s MTC at 4. In March 2012, Arena applied to market Lorcaserin within the European Union. Defs.' Oppo. at 8. A committee of the European Medicines Agency ("EMA") provided Arena with a list of "outstanding issues" in 2013, which included concerns about the Rat Study, valvulopathy, and other matters that "the FDA believed Arena had adequately addressed given its approval of the drug." Id. Arena determined that it could not resolve the issues in the time prescribed by the EMA and withdrew its application. Id.
On January 20, 2017, Lead Plaintiff served Requests for the Production of Documents ("RFP") on Defendants. Pl.'s MTC at 6. Requests 34-37 seek "all documents concerning" 1) the application for approval from the EMA to market the drug in the European Union, 2) the EMA's objections to the "nonclinical and clinical issues concerning Lorcaserin," 3) Defendants' belief that they could not resolve the EMA's objections, and 4) the reasons for Defendants' withdrawal of their application. Id. at 6-7. Defendants timely objected to RFPs 34-37 on May 26, 2017, on the grounds that the information sought is irrelevant and disproportional. Id. at 6; Defs.' Oppo. at 9. The parties met and conferred on June 5, 2017 and June 13, 2017, but were unable to resolve the dispute. Pl.'s MTC at 7.
Lead Plaintiff argues that the requested documents are relevant because they involve the same Rat Study evidence presented to the FDA and "the EMA's objections and discussion of the relevance of the Rat Study to humans directly bear on the issue of Defendants' interpretation of the nonclinical studies and whether Defendants had a `good faith' basis to make their misstatements." Pl.'s MTC at 9. Lead Plaintiff also asserts that the requested documents are relevant "to the issue of whether the misleading statements `were rebutted by contrary information' . . . . [,] whether Defendants' statements were truthful[,] and whether Defendants were `justified' in making these misstatements." Id. Lead Plaintiff further asserts that the fact that the documents post-date the Class Period is irrelevant because they discuss events that occurred during the Class Period and may shed light on the veracity of statements made during the Class Period. Id. Lead Plaintiff does not address the proportionality of his requests. See Pl.'s MTC.
Defendants counter that Lead Plaintiff's "theory `is that Defendants intentionally withheld information material to the market's assessment of whether and when the FDA would likely approve [L]orcaserin.'" Defs.' Oppo. at 9 (citation omitted) (emphasis in original). Accordingly, Defendants argue that only the FDA's concern about Lorcaserin is relevant and that "[w]hatever other regulators may have later thought, based on their own standards and guidelines, cannot change that in the slightest." Id. (citation omitted). Defendants also argue that the requested discovery is not proportional to the needs of this case as it seeks "`all' documents that `concern'" four broad categories of documents and the requested documents have limited, if any, relevance. Id. at 10-11.
To the extent Lead Plaintiff is arguing that the Ninth Circuit's decision in this case requires the production of the requested documents relating to Arena's application to market Lorcaserin in the European Union, Lead Plaintiff is incorrect. See Pl.'s MTC at 4. While the Ninth Circuit's decision held that Defendants had an obligation to disclose the Rat Study results when they made representations regarding other animal studies which indicated a likelihood of FDA approval, the Ninth Circuit did not address the relevance, if any, of the effect of the Rat Study on the EMA and Arena's application for approval within the European Union. See Schueneman, 840 F.3d at 704-709 (9th Ci r. 2016) ("Defendants may not have had a duty to disclose the Rat Study had they not been representing that animal studies supported [L]orcaserin's safety and therefore its likelihood of being approved."). Lead Plaintiff states that the EMA's objections bear on the veracity of Defendants' statements made during the FDA approval process and whether Defendants were justified in making the statements, but Lead Plaintiff does not explain that conclusion given the different standards utilized by the EMA and the FDA and the different time frames of the statements. Moreover, Lead Plaintiff's requests are very broad and he does not explain how documents presented to the EMA, especially those unrelated to the Rat Study, are relevant to the issue in this case of whether Defendants "intentionally withheld information material to the market's assessment of whether and when the FDA would likely approve [L]orcaserin." Id. at 709. Finally, with regard to the Rat Study documents, Lead Plaintiff does not explain what discovery already has been produced in relation to the FDA application and the relevance of non-repetitive documents provided to the EMA. The Court therefore finds that the four document requests are overbroad and seek a large amount of irrelevant information, and the relevance of the remaining responsive documents is minimal given the EU medical standards and the time frames.
Lead Plaintiff also fails to establish that requests 34-37 are proportional to the needs of this case as required by Fed. R. Civ. P. 26(b)(1). See Pl.'s MTC. As previously stated, the requests at issue are extremely broad. See Pl.'s MTC, Declaration of Mario M. Choi in Support of Lead Plaintiff's Motion to Compel ("Choi Decl."), Exhibit B. Defendants indicate that they already have produced thousands of documents and are currently reviewing 200,000 emails and attachments from 16 custodians to produce. Defs.' Oppo. at 11. Defendants explain that they ran test searches on documents already collected and identified 43,000 emails and attachments potentially responsive to Plaintiff's requests at issue. Id. Moreover, Defendants estimate that reviewing material responsive to requests 34-37 for relevance and privilege would take weeks and cost more than $80,000. Id. Given the extremely broad discovery requests, including the fact that the requests are not limited to the Rat Study, the minimal relevance of statements made after the class period in an application in the European Union involving drug standards that are different from those in the United States, and the large number of potentially responsive documents, the Court finds that requests 34-37 are not proportional to the needs of the case.
The Court therefore DENIES Plaintiff's motion to compel a response to RFP numbers 34-37 on the grounds that the requested documents have little, if any, relevance to Lead Plaintiff's theory that "Defendants intentionally withheld information material to the market's assessment of whether and when the FDA would likely approve [L]orcaserin" and are not proportional to the needs of this case. See Schueneman, 840 F.3d at 709.
B. DEFENDANTS' MOTION TO COMPEL
Plaintiffs relied heavily in their SAC on six Confidential Informants ("CI") to plead their claims with particularity. SAC at 5-10, 18-22. These CIs allegedly have information supporting Plaintiffs' claims that Defendants made misrepresentations of material facts which caused economic damages to Plaintiffs. See SAC. Plaintiffs did not identify the CIs by name. See id.
At issue in Defendants' motion to compel is Defendants' Interrogatory 8, which states: "Identify each person identified as a confidential informant in the complaint, including but not limited to, (i) the name of each confidential informant, (ii) the telephone number of each confidential informant, and (iii) the address of each confidential informant." Defs.' MTC, Declaration of Ryan E. Blair in Support of Defendants' Motion to Compel Response to Interrogatory No. 8 Relating to Confidential Witnesses ("Blair Decl."), Exhibit 1 at 10. In response, Lead Plaintiff objects on the grounds that identifying the CIs would violate the attorney work product doctrine. Pl.'s Oppo. at 7.
Lead Plaintiff's initial disclosures list more than 60 individuals, 52 of which are current and former Arena employees, who are believed to have discoverable information. Defs.' MTC at 11; Pl.'s Oppo. at 15. While Lead Plaintiff concedes that the six CIs are on that list, Defendants argue they should not be required to depose dozens of witnesses to determine who the CIs are. Defendants also dispute Lead Plaintiff's objections.
1. Relevance
The threshold discovery issue is whether identifying the CIs is relevant information. Defendants assert that this information is relevant because Lead "Plaintiff quotes or paraphrases the CIs in nearly two dozen paragraphs of the Complaint and they "`unquestionably have relevant information.'" Id. at 9 (citing In re Amgen Inc. Sec. Litig., 2013 WL 12139088, at *3 (C.D. Cal. Dec. 2, 2013)). Notably, Lead Plaintiff does not dispute that the identities of the six CIs are relevant. See Pl.'s Oppo.
The Court finds that the SAC demonstrates that the identities of the six CIs are relevant. The SAC quotes and/or paraphrases the CIs extensively regarding the Rat Study, Arena's knowledge of the Rat Study data, and Arena's alleged misrepresentation of Lorcaserin. SAC at at 5-10, 18-22. The SAC also devotes several footnotes setting out, to various degrees, the backgrounds and qualifications of each of the CIs. Id. at 5 ns.1 & 2, 7 n.3, 8 n.4, 9 n.5, 10 n.6.
In light of these details, Rule 26(b)(1) requires that the names of the six CIs be produced, unless they are held to be privileged. Knowing identities of the CIs will help the defense find and interview and/or depose them. Lead Plaintiff has represented that the six CIs have firsthand knowledge of specific facts tending to establish Defendants' liability for securities fraud and such interviews or depositions are likely to constitute or reveal admissible, and possibly highly probative, evidence. It is also reasonable to expect that Defendants would pursue leads from information provided by the CIs, and that this might yield other admissible evidence. See In re Marsh & McLennan Sec. Litig., 2008 WL 2941215, at *3 (S.D.N.Y. July 30, 2008) ("[b]ecause Lead Plaintiffs relied upon the CWs in drafting the [Complaint], the CWs possess discoverable information") (citations omitted); In re Harmonic, Inc. Secs. Litig., 245 F.R.D. 424, 427 (N.D. Cal. 2007) (holding that "the identities of the [confidential witnesses] are relevant to Plaintiff's claims," and required to be revealed in response to interrogatories); In re Aetna, Inc. Sec. Litig., 1999 WL 354527, at *2 (E.D. Pa. May 26, 1999) (names and addresses of confidential informants to whom factual allegations are attributed in the Complaint are "obviously `relevant to the subject matter involved in the pending action'"). Additionally, identifying the CIs might help Defendants assess the strength of the SAC's claims. Finally, Lead Plaintiff has not argued or established that Defendants' request is not proportional. See Pl.'s Oppo.
2. Work-Product Doctrine
The Court therefore turns to whether the names of the six CIs referenced in the SAC are protected from disclosure under the attorney-work product doctrine.
"[A] party may not discover documents and tangible things that are prepared in anticipation of litigation or for trial by or for another party or its representative (including the other party's attorney, consultant, surety, indemnitor, insurer, or agent)." Fed. R. Civ. P. 26(b)(3)(A). Nevertheless, those materials may be discovered if "(i) they are otherwise discoverable under Rule 26(b)(1); and (ii) the party shows that it has substantial need for the materials to prepare its case and cannot, without undue hardship, obtain their substantial equivalent by other means." Id. However, even when substantial need for work product has been shown, the court must still "protect against disclosure of the mental impressions, conclusions, opinions, or legal theories of a party's attorney or other representative concerning the litigation." Fed. R. Civ. P. 26(b)(3)(B).
The work product doctrine does not protect materials assembled in the ordinary course of business. Rather, the primary motivating purpose behind the creation of the materials must be as an aid in possible future litigation. See Griffith v. Davis, 161 F.R.D. 687, 698-99 (C.D. Cal. June 9, 1995) (citations omitted). That is, work product protection applies only to material "that would not have been generated but for the pendency or imminence of litigation." See id. (citing Kelly v. City of San Jose, 114 F.R.D. 653, 659 (N.D. Cal. Feb. 26, 1987)). Further, "a mere allegation that the work product rule applies is insufficient to invoke its protection." Medina v. County of San Diego, 2014 WL 4793026, at *17 (S.D. Cal. Sept. 25, 2014) (citation omitted).
Defendants contend that the attorney work product doctrine does not protect the identity of witnesses when their statements appear in the complaint. Defs.' MTC at 10. Even if the work product doctrine were to apply, Defendants argue that the qualified protection is overcome because they have a substantial need for the information and obtaining the information by other means would result in an undue hardship. Id. at 9-10. Lead Plaintiff argues that the disclosure of the CIs' identities would reveal counsel's opinions regarding the importance of these witnesses, thereby violating the work product doctrine. Pl.'s Oppo. at 11. Further, Lead Plaintiff asserts that Defendants cannot show a substantial need or undue burden required to overcome the qualified privilege. Id. at 12-16. Finally, Lead Plaintiff argues that disclosure of the CIs' identities would go against public policy. Id. at 16-17.
The names, phone numbers, and addresses of the persons identified in the SAC as CIs are not entitled to work product protection. Lead Plaintiff disclosed the fact that the six CIs (as well as approximately 54 other people) likely possess discoverable information because they identified them by name in the initial disclosures. See Pl.'s Oppo. at 15. The SAC also already disclosed important aspects of what the six CIs have stated about the events at issue in this case and their backgrounds and qualifications. See SAC. All that Defendants seek are the names, phone numbers, and addresses of the six CIs described in the SAC. Defs.' MTC, Blair Decl., Exhibit 1 at 6. This would expedite the discovery process by allowing Defendants to focus its depositions immediately on these important witnesses, rather than having to engage in a costly process of elimination in which it would take numerous depositions simply to determine which of the disclosed names are the six CIs.
Contrary to Lead Plaintiff's argument, revealing the identity of the CIs would not reveal Lead Plaintiff's counsel's mental impressions, opinions, or trial strategy.3 See Plumbers & Pipefitters Local Union No. 630 Pension-Annuity Trust Fund v. Arbitron, Inc., 278 F.R.D. 335, 340 (S.D.N.Y. Nov. 14, 2011) (finding the work product doctrine inapplicable to the identity of confidential informants listed in a complaint). It is both proper and common for a plaintiff to rely on CIs in a complaint, however, "once the discovery phase begins, the balance of interests shifts. The priority becomes reciprocal and robust fact-gathering as the parties seek to discover relevant evidence." Novak v. Kasaks, 216 F.3d 300, 314 (2d Cir. 2000); Plumbers & Pipefitters Local Union No. 630 Pension-Annuity Trust Fund, 278 F.R.D. at 341 (citing IPO Securities Litigation, 220 F.R.D. 30, 37 (S.D.N.Y. Oct. 30, 2003)). A party who attempted to satisfy the pleading requirements by including statements from CIs "may not thereafter refuse to disclose who they are" on the grounds of work product. Ross v. Abercrombie & Fitch Co., 2008 WL 821059, at *3 (S.D. Ohio Mar. 24, 2008).
Accordingly, the Court finds that the work product doctrine is not implicated by granting Defendants' motion to compel. See In re Grand Jury Subpoena Dated July 6, 2005, 510 F.3d 180, 183-84 (2d Cir. 2007); Plumbers & Pipefitters Local Union No. 630 Pension-Annuity Trust Fund, 278 F.R.D. at 340; In re Aetna, 1999 WL 354527, at *2 (enforcing interrogatories that sought the names of witnesses identified in the complaint by such terms as "a former regional general manager at Aetna" or "a former Aetna vice-president of sales and customer service" and finding that the names of these individuals were not protected by the work product doctrine); In re Theragencies Corp. Secs. Litig., 205 F.R.D. 631 (N.D. Ga. 2002) (enforcing interrogatories which sought the names of persons referenced, but not named, in the complaint and rejecting the claim that the information was core work product); In re Harmonic, 245 F.R.D. at 427 (enforcing interrogatories as to the names of five CIs, finding the work product doctrine inapplicable and noting that CI identities constitute factual, as opposed to opinion, work product, and contain "minimal substantive content"); In re Marsh & McLennan, 2008 WL 2941215, at *3 n.5 (S.D.N.Y. July 30, 2008) (enforcing a discovery demand seeking production of "documents sufficient to identify each and every" of the 17 CIs referenced in the complaint" and rejecting Plaintiff's contention that revelation of the identity of a CI reveals more about an attorney's mental processes than does the identification of a witness by name in the complaint itself).
3. Conclusion
Because the identities of the six CIs listed in the SAC are relevant and do not implicate protection under the work product doctrine, the Court GRANTS Defendants' motion to compel.
CONCLUSION
For the reasons stated herein, the Court finds that:
1. Lead Plaintiff's motion to compel production of documents responsive to requests 34-37 [ECF No. 117] is DENIED; and
2. Defendants' motion to compel disclosure of the names, addresses, and phone numbers of the CIs [ECF No. 113] is GRANTED. The CIs' names, addresses, and phone numbers are to be provided to the defense by July 28, 2017.
IT IS SO ORDERED.