Defendants' Motion to Compel (ECF No. 77)

*1 On March 17, 2020, the parties filed a Joint Stipulation (alternatively “JS” (ECF No. 77-1)) in support of their positions regarding defendants' Motion to Compel (“Motion to Compel” or “MTC” (ECF No. 77)) plaintiff to further respond to: (1) defendants' Request for Production (“RFP”) numbers 1-12, 16-21, 23-29, and 33-36; and (2) defendants' Interrogatory numbers 1-9 and 21 (collectively the “Subject Discovery”). (Mot. at 2). Defendants seek an order (a) overruling plaintiff's objections to the Subject Discovery; (b) compelling plaintiff to search for and produce all responsive documents, including all electronically stored information[1] (“ESI”) in response to RFP numbers 1-12, 16-21, 23-29, and 33-36, within five days of the hearing date; (c) compelling plaintiff to produce a privilege log within five days of the hearing date for any documents it withholds on privilege grounds; and (d) compelling plaintiff to provide further responses to the subject Interrogatories within five days of the hearing date. (Id.). On March 19, 2020, the Court took the April 8, 2020, hearing on the Motion to Compel off calendar. (ECF No. 82). On March 20, 2020, defendants filed a Supplemental Memorandum (alternatively “Supp'l Mem.” (ECF No. 85)), and a Request for Judicial Notice (alternatively “RJN” (ECF No. 86)). On March 24, 2020, plaintiff and defendants each filed a Request for Judicial Notice of various documents.[2] (ECF Nos. 87, 88). On March 25, 2020, plaintiff filed its Supplemental Memorandum. (ECF No. 90).

By way of background, on November 27, 2019, defendants served Interrogatories and RFPs on plaintiff. (MTC at 2). Defendants contend that plaintiff's deficient discovery responses have affected defendants' ability to complete discovery by the July 31, 2020, Scheduling Order deadline. (JS at 3; see also ECF No. 53 (“Scheduling Order”)). They contend that plaintiff (1) failed to produce any ESI; (2) unreasonably withheld its profit and loss statements on grounds of relevance, despite placing its financial condition at issue with allegations of monetary and property losses; (3) refused to identify its small clinic customers, despite the direct relevance of this information to plaintiff's claim regarding the “inelastic” demand for the product; (4) refused to produce any information regarding its ongoing clinical trials evaluating sodium thiosulfate as a treatment for calciphylaxis on relevance and confidentiality grounds; (5) refused to produce information regarding its communications with the FDA; (6) refused to provide any information regarding its other Hope companies that also sell sodium thiosulfate to dialysis providers; (7) refused to produce information regarding its FDA applications to sell sodium thiosulfate; and (8) improperly asserted relevance, undue burden, and vague and ambiguous objections without any explanation or supporting evidentiary declarations. (Id. at 3-4).

*2 The parties have grouped their disputed requests into several categories: (1) relevance and undue burden objections; (2) plaintiff's drug formulations, new drug applications (“NDAs”), and clinical trials; (3) identification of plaintiff's customers; (4) damages evidence; (5) plaintiff's communications with the FDA; (6) information about plaintiff's foreign affiliates; (7) production of ESI; and (8) confidentiality objections. Many of the Subject Requests fall into more than one of these categories.[3]

Legal Standard

The Court will examine the issues in the Motion to Compel using the general standard set forth in Federal Rule of Civil Procedure 26 (“Rule 26”). Rule 26 provides that a party 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[.]” Fed. R. Civ. P. 26(b)(1). Factors to consider include “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.” Id. Information need not be admissible in evidence to be discoverable. Id. However, a court “must limit the frequency or extent of discovery otherwise allowed by [the Federal] rules” if “(i) the discovery sought is unreasonably cumulative or duplicative, or can be obtained from some other source that is more convenient, less burdensome, or less expensive; (ii) the party seeking discovery has had ample opportunity to obtain the information by discovery in the action; or (iii) the proposed discovery is outside the scope permitted by Rule 26(b)(1).” Fed. R. Civ. P. 26(b)(2)(C). Finally, the Court is mindful of the imperative that the Federal Rules of Civil Procedure be “construed, administered, and employed by the court and the parties to secure the just, speedy, and inexpensive determination of every action and proceeding.” Fed. R. Civ. P. 1 (emphasis added); see also Landis v. N. Am. Co., 299 U.S. 248, 254-55, 57 S. Ct. 163, 81 L. Ed. 153 (1936) (a court has the inherent power “to control the disposition of the causes on its docket with economy of time and effort for itself, for counsel, and for litigants” and “[h]ow this can best be done calls for the exercise of judgment, which must weigh competing interests and maintain an even balance”).

Relevance “has been construed broadly to encompass any matter that bears on, or that reasonably could lead to other matter that could bear on, any issue that is or may be in the case.” Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 340, 351, 98 S. Ct. 2380, 57 L. Ed. 2d 253 (1978) (citing Hickman v. Taylor, 329 U.S. 495, 501, 67 S. Ct. 385, 91 L. Ed. 451 (1947)). Even so, the scope of discovery is not without limits as Rule 26(b) (as amended in 2015) now provides that discovery is limited to information that is relevant to a claim or defense in the lawsuit and proportional to the needs of the case. The party seeking to compel discovery “has the initial burden of demonstrating relevance” under Rule 26. See Integon Preferred Ins. Co. v. Saavedra, 2019 WL 4228372, at *2 (C.D. Cal. July 12, 2019) (citations omitted). Thereafter, “[t]he party who resists discovery has the burden to show discovery should not be allowed, and has the burden of clarifying, explaining, and supporting its objections.” Duran v. Cisco Sys., Inc., 258 F.R.D. 375, 378 (C.D. Cal. 2009) (citing Blankenship v. Hearst Corp., 519 F.2d 418, 429 (9th Cir. 1975); Sullivan v. Prudential Ins. Co. of Am., 233 F.R.D. 573, 575 (C.D. Cal. 2005)).

Relevance and Undue Burden Objections (RFP Nos. 4, 7, 9, 11, 21, 23, 24, 26, 33)

*3 Plaintiff devoted much of its preliminary statement to discussing why its relevance and undue burden objections to these RFPs -- and to the other Subject Discovery requests -- have merit. (JS at 4). It generally argues that its NDAs, clinical trials, communications with the FDA, financial information, drug formulations, and the identity of its customers are not relevant to any claim or defense and, because defendants are seeking trade secret information, the production of that information would not be proportional to the needs of the case. (Id. (citation omitted)).

In support, plaintiff specifically notes that it alleged in its First Amended Complaint (“FAC”) that defendants violated the unfair competition laws of the states of California, Florida, Tennessee, South Carolina, and Connecticut by selling drugs that are “essentially a copy” of plaintiff's FDA-approved drug, and by violating the individual prescription and customization requirements of Section 503A of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 353a and 353b. (Id. at 5-6). It notes that defendants “operate under the guise of ‘drug compounding,’ ” and that drugs generally need to be approved by the FDA prior to their sale, although an exemption to this approval requirement exists for lawfully compounded drugs. (Id. at 5). The exemptions are set forth in section 503A (for small compounding pharmacies) and section 503B (for large outsourcing facilities), of the FDCA. (Id.).

Plaintiff contends that defendants' drugs do not qualify for any exemption to the FDA approval requirement and that with respect to defendants' 503B outsourcing facilities, defendants use a bulk drug substance not on the FDA's clinical needs list. (Id.). They assert that “[n]othing about any of Plaintiff's drugs or business practices is relevant to this issue.” (Id.). Plaintiff also contends that defendants are violating § 503B's prohibition against selling drugs that are “essentially a copy” of Hope's FDA-approved drug, “because the practitioners who have prescribed Defendants' drugs have not determined (and have not documented any determination) that a compounded drug will produce for the individual patient a clinical difference.” (Id. (citation omitted) (internal quotation marks omitted)). Determining whether defendants' drugs are “essentially a copy” of plaintiff's FDA-approved drug “requires no discovery about [plaintiff's] [NDAs] or clinical trials or ‘formulation,’ discovery of which would require the disclosure of trade secrets.” (Id. at 5-6). Plaintiff asserts that under § 503B, a compounded drug made with the same bulk drug substance that is a component of an FDA-approved drug “is ‘essentially a copy’ and therefore illegal, unless there is a ‘change that produces a clinical difference for a patient as determined by the prescribing practitioner ... [and] the determination [must be] noted on the prescription or order ... for the compounded drug.’ ” (Id. at 6 (citing Pl.'s RJN Ex. A at 9) (italics and brackets in original)).

Plaintiff also argues that defendants' § 503A compounding pharmacies are selling drugs that are “essentially a copy” of plaintiff's sodium thiosulfate drug. Under § 503A, a drug is “essentially a copy” if the compounded drug “has the same active pharmaceutical ingredient, in same or similar dosage strength, with the same route of administration.” (Id. (citing Pl.'s RJN Ex. B at 5-6)). It states that its active ingredient, dosage strength, and route of administration are a matter of public record, and asserts that there is nothing in its NDAs, clinical trials, or communications with the FDA that could be of any relevance to this determination. (Id.). Plaintiff also submits that defendants are violating the individual prescription and customization requirements of § 503A that require a compounding pharmacy to obtain a valid prescription order that includes a statement from the prescribing practitioner that a compounded drug is medically necessary for the identified patient and that “an FDA-approved drug is not medically appropriate.” (Id. (citing Allergan v. Imprimis, 2019 WL 3029114, at *11 (C.D. Cal. July 11, 2019))). Plaintiff asserts that such a determination does not require discovery of plaintiff's NDAs, clinical trials, drug formulations, or communications with the FDA. (Id. at 6-7).

*4 Plaintiff further submits that defendants (1) have not asserted any counterclaim regarding plaintiff's drugs or business practices; (2) have pleaded eight affirmative defenses; and (3) have “made no effort to link the contested discovery requests to any of their affirmative defenses, either in the meet and confer process or in th[e] joint stipulation.” (Id. at 7). Plaintiff argues that its “drugs and business practices are not on trial here,” and that as plaintiff's primary competitor, defendants are “trying to use the discovery process to steal trade secrets about Plaintiff's drugs, its manufacturing and testing processes, and information regarding Plaintiff's clinical trials, in order to copy Plaintiff's drugs and compete unfairly.” (Id. (citing Sherman Decl. ¶¶ 4-14)). It further argues that the attorneys' eyes only protective order in place in this case does not safeguard the confidentiality of documents at trial and if irrelevant documents are disclosed to defendants' attorneys, “Plaintiff has no doubt that Defendants will publish them at trial on some pretext for the purposes of stripping them of their protected status.” (Id.).

Plaintiff states that it has supported its relevance and undue burden objections with the declarations of Craig Sherman, the president of plaintiff Hope Medical Enterprises, Inc. (ECF No. 78-1, 79); and plaintiff's counsel, Joseph N. Akrotirianakis (ECF No. 77-3). (JS at 28). It argues that it has “narrowly tailored its objections to each request,” and that its objections are not boilerplate. Plaintiff generally states with respect to its undue burden objections, that the undue burden is “in the form of having to disclose its trade secret information to its principal competitor.” (Id. at 29).

With respect to plaintiff's relevance and undue burden objections asserted as to RFP numbers 4, 7, 9, 11, 21, 23, 24, 26, and 33, defendants submit only that these objections should be overruled because plaintiff asserted these objections without explanation (relevance objections) or evidentiary declarations (undue burden objections).[4] (Def'ts' Supp'l Mem. at 5).

Having analyzed plaintiff's and defendants' contentions submitted with respect to RFP numbers 4, 7, 9, 11, 21, 23, 24, 26, and 33, the Court finds that the terms of the stipulated Protective Order are sufficient to address plaintiff's undue burden concerns. Additionally, plaintiff has provided sufficient explanation to the Court showing that its NDA applications, its clinical trials, its communications with the FDA, and its profit and loss statements (at least under some circumstances as discussed in more detail below) -- which are the subject of RFP numbers 4, 7, 9, 11, 21, 23, 24, 26, and 33 -- are not relevant to the claims and defenses in this action and proportional to the needs of the case.

Accordingly, defendants' Motion to overrule plaintiff's relevance objections with respect to RFP numbers 4, 7, 9, 11, 21, 23, 24, 26, and 33 for lack of an explanation is denied. The parties' additional arguments on relevance and other grounds relating to plaintiff's drug formulations, NDAs, clinical trials, customer identification, damages evidence, communications with the FDA, and foreign entity information, are discussed in more detail below. Defendants' Motion to overrule plaintiff's undue burden objections to RFP numbers 4, 7, 9, 11, 21, 23, 24, 26, and 33 is granted.

Drug Formulations, NDAs, and Clinical Trials (RFP Nos. 4-12, 20-21; Interrogatory Nos. 3-9)

Defendants note that RFP numbers 4-12, 20-21, and Interrogatory numbers 3-9 seek information regarding plaintiff's drug formulations, NDAs, and clinical trials. (Def'ts' Supp'l Mem. at 1). They disagree that their potassium-free sodium thiosulfate is a copy of plaintiff's drug, as there are differences in the products' formulations. (Id.). Thus, according to defendants, the formulations of plaintiff's drug over the time period it claims that defendants were selling copies of the drug, “are directly relevant to the claims and defenses” in this action. (Id.). They note that plaintiff requested defendants' drug formulation in discovery and that this Court previously compelled production.[5] (Id. (citing ECF Nos. 68-1 at 73, 76 at 4)). They further assert that plaintiff's interpretation of FDA regulations and guidance documents to limit discovery of relevant formulation information “is improper because Plaintiff is not qualified to provide expert testimony on this issue, and in any event, the interpretation of the FDA rules is a legal issue solely within the province of this Court.” (Id. (citing Wilson v. Odawall, Inc., 2018 WL 3250161, at *4 (C.D. Cal. June 22, 2018))).

*5 Defendants state that plaintiff's trade secret objection to producing NDAs containing its product formulations is improper because: (1) the stipulated Protective Order issued in this action is sufficient to address plaintiff's trade secret concerns; and (2) the Code of Federal Regulations provides that once an NDA has been approved, “significant amounts of information summarizing the safety and effectiveness data submitted by the manufacturer and detailing the agency's basis for approval become available to the public.” (Id. (quoting 21 C.F.R. § 314.430; Citizens Comm'n on Human Rights v. FDA, 1993 WL 1610471, at *7 (C.D. Cal. May 10, 1993))). Defendants also submit that plaintiff's trade secret objection to producing clinical trial information is also unavailing because details regarding plaintiff's clinical trials have been “located on a variety of public websites for years,” including plaintiff's own website and clinicaltrials.gov, a website provided by the United States National Library of Medicine. (Id. at 2 (citing RJN Exs. C, D)). They also suggest that plaintiff's statements in its “multiple FDA applications regarding sodium thiosulfate formulations, particularly its Orphan Drug Application to use its product to treat calciphylaxis, are also directly relevant to the disputed issue of whether Defendants' product is essentially a copy of Plaintiff's product.” (JS at 24).

Plaintiff argues that notwithstanding the existence of the stipulated Protective Order in this action, where the burden to a litigant from disclosing its trade secret or confidential information to a direct competitor outweighs the litigation benefit the competitor may derive from the information, a motion to compel will be denied. (JS at 25 (citations omitted)). It states that its NDAs by definition contain trade secret information about how a pioneer drug product is formulated, composed, manufactured, and quality controlled. (Id. at 26 (citing Citizens Comm'n on Human Rights, 1993 WL 1610471, at *7)). Plaintiff also asserts that trade secrets are exempt from disclosure by the FDA. (Id. (citing 21 C.F.R. § 20.61)). It states that the information in the NDAs “would be incredibly valuable to competitors like Defendants,” that the NDAs are not relevant to any of plaintiff's claims, and that, according to the FDA, whether a drug is “essentially a copy” requires only three pieces of information: “the active ingredient, the dosage, and the route of administration” -- all of which is publicly available information. (Id. at 27 (citing Pl.'s RJN Exs. 1-2)). Plaintiff argues that it has accused defendants of selling “a copy of Plaintiff's drug in contravention of 503A and 503B,” and that this allegation does not open the door to discovery of all aspects of plaintiff's drug, “including the information set forth in Plaintiff's new drug and orphan drug applications to the FDA, Plaintiff's clinical trials, and the formulation of Plaintiff's drug.” (Pl.'s Supp'l Mem. at 1). It also states that FDA guidance published in January 2018, “make[s] clear that non-public information about Plaintiff's drug is not relevant to a determination whether Defendants' drugs are ‘essentially a copy’ of Hope's Sodium Thiosulfate Injection.” (Id.).

Based on the foregoing, the Court determines that other than with respect to the active ingredient, dosage, and route of administration of plaintiff's drug -- which is publicly available information and relevant to plaintiff's claim that defendants' drug is “essentially a copy” pursuant to § 503A -- information and documents relating to plaintiff's NDAs, drug formulations, and clinical trials is not relevant to the claims and defenses in this action and proportional to the needs of the case. Defendants' Motion to Compel a further response to RFP numbers 4-12 and 20-21, and Interrogatory numbers 3-9 is granted in part. No later than April 21, 2020, plaintiff shall produce documents reflecting the active ingredient, dosage, and route of administration of its drug. In all other respects, defendants Motion to Compel a further response to RFP numbers 4-12 and 20-21, and Interrogatory numbers 3-9 is denied. However, to the extent that plaintiff agreed to produce documents or information in response to individual requests (see, e.g., response to RFP number 20 (plaintiff agreed to produce documentation regarding communications between it and dialysis companies that operate community dialysis centers in the five subject states “other than communications relating to Hope's clinical trials”)), and the information or documents plaintiff agreed to produce has not yet been produced,[6] plaintiff shall provide all responsive information or documents in its possession, custody or control no later than April 21, 2020.

Customer Identification (RFP No. 17)

*6 RFP number 17 asked plaintiff to produce documents relating to the marketing and sale of sodium thiosulfate to dialysis providers by Hope and any of its entities, including its entities in Canada and the UK. (JS at 91).

Plaintiff explains that it generated a report of its sales to dialysis customers in the five states, but redacted the names of its smaller dialysis customers “whose identities are trade secret and irrelevant to the litigation.” (Id. at 97). It notes that customer lists are routinely afforded trade secret protection, and states that it agreed to produce, “and then did produce, a report showing the quantity, dates and locations of its sales of sodium thiosulfate to dialysis companies in the five states.” (Id. at 98). It also states that the identity of its customers is irrelevant to the damages calculation, and to whether defendants' drugs are essentially a copy of plaintiff's FDA-approved drug. (Id. at 98, 99). Plaintiff asserts that its affiliates in Canada and the UK “do not sell any sodium thiosulfate anywhere in the United States, let alone in the five states ... at issue here.” (Id. at 100). Plaintiff further argues that defendants have not articulated why the identities of plaintiff's customers are relevant to damages and discoverable. (Pl.'s Supp'l Mem. at 4).

Defendants contend that plaintiff's trade secret objection to producing information regarding its customers is improper because this information is “directly relevant to the disputed issue of customers' demand for sodium thiosulfate, which affects the parties' respective sales,” and to plaintiff's claim of customer confusion. (Def'ts' Supp'l Mem. at 2 (citing ECF No. 22-3 ¶ 11; Virco Manuf'g Corp. v. Hertz Furniture Systs., 2014 WL 12591482, at *4-5 (C.D. Cal. Jan. 21, 2014) (compelling customer identification information because “the information is, at a minimum, relevant to the issue of consumer confusion.”))).

Plaintiff acknowledges that it “provided the Court with examples of consumer confusion in connection with Plaintiff's withdrawn motion for a preliminary injunction,” as evidenced by certain clinics contacting plaintiff about orders the clinic had placed with defendants and then did not receive. (Pl.'s Supp'l Mem. at 4). It states that in addition to the report of its sales, it has produced the communications referenced by Dr. Sherman between Hope and employees of DaVita and Fresnius (the two biggest dialysis companies in the United States (JS at 88 n.1)), but submits that evidence of consumer confusion does not open the door to forcing plaintiff to disclose the identity of its smaller customers. (Pl.'s Supp'l Mem. at 4). Plaintiff also states that it has already produced (1) a report of its sales in the five states showing the quantity, dates, and locations of its sales, and (2) communications with DaVita and Fresnius reflecting consumer confusion. This implies, however, that plaintiff did not produce evidence reflecting consumer confusion on the part of its smaller customers, if any exists.

Defendants' Motion to Compel plaintiff to produce additional documents in response to RFP number 17 is granted in part. To the extent plaintiff has not produced all documents in its possession, custody or control that reflect “consumer confusion” on the part of its smaller customers, no later than April 21, 2020, it shall produce all such responsive documents, with the name of the customer(s) redacted. If plaintiff contends that there are no such responsive documents in its possession, custody or control, then no later than April 21, 2020, plaintiff must submit to defendants a declaration signed under penalty of perjury by a corporate officer so stating.

Damages Evidence (RFP No. 33)

*7 RFP number 33 seeks profit and loss statements from Hope and its entities. (JS at 150).

Defendants claim that plaintiff's refusal to provide its profit and loss statements after putting its financial condition at issue by claiming substantial lost profits is contrary to well-established law. (Def'ts' Supp'l Mem. at 3 (citations omitted)). Defendants contend that this information is “particularly relevant” in this case, “where Plaintiff claims that it is a very small company, yet alleges that it would have made every sale Defendants made over the past 8 years but for Defendants' sale of copies of Plaintiff's drug.” (Id. (citing FAC ¶ 96)). Defendants also point out that plaintiff “now claims [in the JS] that the information is irrelevant because its profit and loss statements contain information about the company's performance as a whole and [plaintiff] is waiting for Defendants' production of its sales and profits.” (Id. (citing JS at 153-54)). They note that Dr. Sherman's declaration that was filed over six months ago “specifically includes information regarding Plaintiff's profitability” and that Dr. Sherman stated that “[d]uring the period without competition from Defendants' compounded sodium thiosulfate product, Hope's sales were 44% higher in California, 146% higher in Connecticut, 67% higher in Florida, 134% higher in South Carolina, and 20% higher in Tennessee.” (Id. (citing ECF No. 22-3 ¶ 19)).

Plaintiff submits that its annual profit and loss statements are not relevant to any issue in this case, including whether plaintiff has suffered any damages relating to the profitability of its sodium thiosulfate injection. (JS at 153, 154). It notes that its profit and loss statements contain information about the company's performance as a whole, and not information about the profitability of plaintiff's sodium thiosulfate injection specifically. (Id. at 153). It states that it has not yet determined whether the monetary damages it will seek under the unfair practices acts of each of the five states “will take the form of [plaintiff's] lost profits for sales it would have made but for Defendants' violations of the laws” of those states, “or whether it will seek disgorgement of Defendants' profits.” (Id.). Plaintiff states that if it decides to seek its own lost profits, then it will produce information regarding its “revenues, costs, and profits from its sales of its own FDA-approved Sodium Thiosulfate Injection in sufficient time to enable Defendants to complete discovery.” (Id. at 154 (citing Sherman Decl. ¶ 15)). Plaintiff further argues that there is no blanket rule that a claim for damages makes a plaintiff's profit and loss statements discoverable. (Id.). Plaintiff acknowledges that in the declaration previously submitted from Dr. Sherman, he discussed plaintiff's increasing sales in each of the five states at issue during a seven-month period when defendants' “unlawful drugs were unavailable,” in order to show under the unfair competition laws of the five states that it has lost money and property in each state as a result of defendants' unlawful sales. (Pl.'s Supp'l Mem. at 4-5). It argues, however, that “there is no nexus between this fact and Plaintiff's profit and loss statements.” (Id.).

*8 Defendants' Motion to Compel a further response to RFP number 33 is granted in part. The expert discovery cut-off in this action is set for June 15, 2020, and the fact discovery cut-off is set for July 31, 2020, i.e., both dates are rapidly approaching. Information reflecting plaintiff's “revenues, costs, and profits from its sales of its own FDA-approved Sodium Thiosulfate Injection” is relevant to plaintiff's damages calculation in the event it seeks monetary damages based on its lost profits. Accordingly, no later than April 21, 2020, plaintiff shall produce all documents reflecting its “revenues, costs, and profits from its sales of its own FDA-approved Sodium Thiosulfate Injection” in the five states at issue, unless it affirmatively confirms, in a declaration signed under penalty of perjury by a corporate officer and by counsel, that it will not under any circumstances seek its lost profits at trial.

Communications with the FDA (RFP No. 23; Interrogatory No. 21)

RFP number 23 seeks the production of documents regarding any communications between “current and former agents, representatives or employees of Hope and the FDA regarding any Defendant” (JS at 126); Interrogatory number 21 asks plaintiff to provide the name and identifying information of any current or former agent, representative or employee who communicated with the FDA regarding defendants. (Id. at 180).

Defendants contend that plaintiff's refusal to produce information regarding its communications with the FDA based on relevance and trade secret grounds is unjustified because plaintiff's prior statements to the FDA, “including those ... regarding allegedly unlawful sales of copies of Plaintiff's product, bear on important factors in the case -- Plaintiff's credibility and the underlying merits of the case.” (Def'ts' Supp'l Mem. at 3-4). Defendants also take issue with plaintiff's characterization of its discussions with the FDA regarding defendants as constituting “trade secrets.” (Id. at 4 (citing JS at 180-81)). They assert that “through their investigation” they learned that plaintiff “contacted the FDA regarding Defendants' product, which prompted an unwarranted inquiry from the agency.” (JS at 180 (citing Francis Decl. ¶ 18)).

Plaintiff argues that its communications with the FDA are non-public and made in the context of plaintiff's NDAs and clinical trials. (Id.). It states that defendants' arguments about the relevance of plaintiff's communications with the FDA boil down to “we want to know what Plaintiff might have said about us because we want to know,” and argues that defendants have put forth no legitimate or good faith argument for how this information relates to any claim or defense in this litigation. (Id.). Plaintiff also submits that these discovery requests “appear[ ] to be a fishing expedition, pure and simple,” and that there is no reasonable basis to think that plaintiff said anything to the FDA about defendants that is exculpatory. (Id. (stating that “Plaintiff certainly is not telling FDA behind the scenes that what Defendants are doing is legal”); Pl.'s Supp'l Mem. at 5).

Defendants have not demonstrated that the information being sought is relevant to the claims or defenses in this action and proportional to the needs of the case. The Court will not permit what appears to be a fishing expedition into documents with little to no apparent probative value. See Riveria v. NIBCO, 364 F.3d 1057, 1072 (9th Cir. 2004) (noting that district courts “need not condone the use of discovery to engage in fishing expeditions”). Defendants' Motion to Compel a further response to RFP number 23 and Interrogatory number 21 is denied.

Foreign Entity Information (RFP Nos. 1-6, 8-11, 16-18; Interrogatory Nos. 1-9)

Defendants assert that information regarding plaintiff's “foreign entities is directly relevant to the nature and extent of Plaintiff's alleged lost sales over the course of 8 years,” as they all sell sodium thiosulfate to dialysis providers and receive product directly from plaintiff's Arizona headquarters. (Def'ts' Supp'l Mem. at 4). Revenues and profits generated from these sales provide information regarding plaintiff's historic business performance “and the extent to which factors other than Defendants' alleged sales of copies of Plaintiff's product, contributed to or caused Plaintiff's alleged lost profits.” (Id.).

*9 Plaintiff argues that its affiliates in Canada and the UK do not sell any sodium thiosulfate product in the United States, “let alone in the five states ... at issue here,” and that only “Plaintiff sells Hope's drugs in the Five States.” (JS at 11; Sherman Decl. ¶ 16). It states that its affiliates in Canada and the UK only sell in those countries and that whether its foreign affiliates receive product directly from plaintiff's Arizona headquarters “has no bearing on the claim[s] or defense[ ]s in this case or on Plaintiff's lost profits.” (Pl.'s Supp'l Mem. at 5; Sherman Decl. ¶ 16). Plaintiff asserts that it has provided defendants with information “about all of the sales made by any Hope entity to dialysis companies in the Five States.” (JS at 11; Sherman Decl. ¶ 20). As noted, Dr. Sherman has attested to each of these facts in his Declaration, signed under penalty of perjury.

Plaintiff's sale of its drug by its foreign entities or outside of the five states at issue here is not relevant to the parties' claims or defenses or proportional to the needs of the case. To the extent defendants are seeking production of documents or information regarding sales outside of the five states by Hope or its Canada or UK affiliates, defendants' Motion to Compel a further response to RFP numbers 1-6, 8-11, and 16-18, and Interrogatory numbers 1-9 is denied.

Electronically Stored Information (RFP Nos. 1-12, 16-21, 23-29, 33-36)

Defendants argue that plaintiff has failed to comply with Rule 34 of the Federal Rules of Civil Procedure with respect to the production of ESI. (Def'ts' Supp'l Mem. at 4 (citing Fed. R. Civ. P. 34(b)(2)(E))). They note that plaintiff has “produced only 212 pages of documents in a case in which they allege 8 years' worth of lost sales in 5 states” (id.) and complain that plaintiff's production was “in multipage PDF form without metadata.” (JS at 8). They further note that plaintiff has stated that the reason for the small number of documents it has produced is that “they are a very small company and have produced all responsive information.” (Id.). Defendants suggest that there should be far more responsive documents because, as a pharmaceutical company, plaintiff is subject to stringent record-keeping requirements regarding its drug sales; its “inspection records” indicate that its distribution and sales records are kept onsite; and it has acknowledged having more records than it has produced. (Id. at 4-5 (citing ECF No. 31-1 ¶¶ 3, 5; JS at 9)).

Plaintiff states that defendants' Local Rule 37-1 letter did not make any mention of ESI, and the requests themselves did not ask for metadata, or specify the format of plaintiff's document production and, therefore, the issue is not properly before the Court in this Motion to Compel. (JS at 8, 28). It explains that it has not produced any documents or ESI in response to certain requests “because th[e] request seeks information about New Drug Applications for sodium thiosulfate -- information that is unrelated to any claim or defense but contains Plaintiff's trade secrets.” (Id. at 28). In his Declaration, Dr. Sherman detailed the steps he took to search for ESI in response to RFP numbers 1-29 and 34-36.[7] (Sherman Decl. ¶¶ 17-28).

Defendants respond that plaintiff did not produce any documents until February 1, 2020, and February 12, 2020, which was after defendants had already served their January 23, 2020, Rule 37 letter. (JS at 17). They state that, in any event, they raised this issue with plaintiff's counsel in a detailed e-mail on February 10, 2020, “well before this Joint Stipulation.” (Id.). In their Supplemental Memorandum, defendants do not raise the issues of plaintiff's alleged failure to include metadata in its production or the format of plaintiff's production.

*10 In this instance, the Court will not elevate form over substance with respect to defendants' failure to mention ESI in its initial Local Rule 37-1 letter. It appears, however, that defendants did not request metadata or specify any format for the production of ESI. Indeed, in their Joint Rule 26(f) Report, the parties agreed only that “discovery should be produced in the form required by the Federal Rules of Civil Procedure.” (ECF No. 52 ¶ IV(3)(c)). Defendants' Motion to Compel a further response in the form of ESI to RFP numbers 1-12, 16-21, 23-29,[8] and 33-36, is granted in part. Except to the extent that any of these requests seek ESI relating to information that falls outside of the scope of the Court's Order herein (e.g., relating to plaintiff's NDAs, clinical trials, or communications with the FDA), no later than April 21, 2020, plaintiff shall search for and produce all responsive ESI in its possession, custody or control that has not already been produced. Because defendant did not “specify a form for producing” ESI, plaintiff may produce the responsive ESI “in a form or forms in which it is ordinarily maintained or in a reasonably usable form or forms,” without metadata (as defendants have provided no basis for the production of metadata), in accordance with Rule 34(b)(2)(E) of the Federal Rules of Civil Procedure. If plaintiff contends that it has already produced all responsive ESI in its possession, custody or control, then no later than April 21, 2020, plaintiff must submit to defendants a declaration signed under penalty of perjury by a corporate officer, so stating.

Confidentiality Objections (RFP Nos. 3-12, 16-17, 21, 23)

Defendants assert that plaintiff's withholding of documents on confidentiality grounds is improper because the stipulated Protective Order issued on December 30, 2019 (ECF No. 62) is sufficient to address issues regarding the confidential and proprietary nature of the parties' documents. (Def'ts' Supp'l Mem. at 5 (citing ECF No 76 at 4)).

Plaintiff responds that it has not withheld any documents on this ground. (JS at 19). Instead, it has redacted the names of its smaller dialysis customers, whose identities are trade secret and irrelevant to the litigation. (Id.; see also discussion above regarding Formulations, and Customer Identification for additional arguments made by plaintiff).

For the reasons discussed above relating to customer identification (RFP No. 17), defendants' Motion to Compel further response to RFP numbers 3-12, 16-17, 21, and 23 is denied. However, no later than April 21, 2020, plaintiff must submit to defendants a declaration signed under penalty of perjury by a corporate officer, attesting that it has not withheld any documents responsive to these RFPs on the ground of confidentiality.

Privilege Log

If plaintiff withholds any documents on the basis of attorney-client privilege or the work product doctrine, no later than April 28, 2020, plaintiff shall provide a sufficiently detailed privilege log to enable defendants to evaluate the applicability of the privilege or other protection asserted. Fed. R. Civ. P. 26(b)(5); Clarke v. Am. Comm. Nat'l Bank, 974 F.2d 127, 129 (9th Cir. 1992); see The Rutter Group, Cal. Practice Guide, Fed. Civ. Proc. Before Trial, Form 11:A (Privilege Log). Failure to provide sufficient information may constitute a waiver of the privilege. See Eureka Fin. Corp. v. Hartford Acc. & Indem. Co., 136 F.R.D. 179, 182-83 (E.D. Cal. 1991).

Defendants' Motion to Strike (ECF No. 80)

On March 18, 2020, defendants filed a “Motion to Strike Settlement Discussions from Plaintiff's Portion of Joint Stipulation on Defendants' Motion to Compel” (“Motion to Strike” or “MTS” (ECF No. 80)). On March 19, 2020, the Court took the April 15, 2020, hearing on defendants' MTS off calendar. (ECF No. 83). On March 25, 2020, plaintiff filed an Opposition (“Opp'n”) to the MTS. (ECF No. 91). On March 27, 2020, defendants filed a Reply. (ECF No. 94).

Defendants seek to strike “the substance of the settlement negotiations from Plaintiff's portion of the Joint Stipulation and Plaintiff's counsel's accompanying declaration” on the grounds that (1) the settlement negotiations are irrelevant under Rule 401, (2) the public disclosure of the settlement negotiations violates public policy and unfairly prejudices Defendants, and (3) the settlement negotiations are inadmissible under Rule 408. (MTS at 2).

*11 Plaintiff responds that settlement negotiations are not privileged communications; Rule 408 only bars the use of settlement discussions at trial; and, even if Rule 408 was applicable, “the Rule on its face only makes evidence of compromise discussions inadmissible when offered to ‘prove or disprove the validity or amount of a disputed claim’ and certain impeachment scenarios not relevant here.” (Opp'n at 3 (citing Fed. R. Evid. 408)). Plaintiff also argues that its “evidence related to the purported ‘settlement discussions’ is offered to explain Defendants' true motive in seeking Hope's profit and loss statements.” (Id.).

Plaintiff's proffer, however, is nothing more than pure speculation. Plaintiff also failed to address defendants' public policy and unfair prejudice arguments. In any event, defendants' Motion to Strike (ECF No. 80) is granted. All references to the parties' settlement negotiations, whether in the Joint Stipulation or in the Declaration of plaintiff's counsel Joseph N. Akrotirianakis (ECF No. 77-3) are stricken and were not considered by the Court in deciding whether defendants are entitled to plaintiff's profit and loss statements or for any other reason.

As set forth herein, defendants' Motion to Compel (ECF No. 77) is granted in part and denied in part.

IT IS SO ORDERED.

As described in Rule 34 of the Federal Rules of Civil Procedure, ESI includes “writings, drawings, graphs, charts, photographs, sound recordings, images, and other data or data compilations -- stored in any medium from which information can be obtained either directly or, if necessary, after translation by the responding party into a reasonably usable form.” Fed. R. Civ. P. 34(a)(1). If a request does not specify a form for producing ESI, “a party must produce it in a form or forms in which it is ordinarily maintained or in a reasonably usable form or forms.” Fed. R. Civ. P. 34(b)(2)(E).

The parties' Requests for Judicial Notice (ECF Nos. 86, 87, 88) are granted.

RFP number 17, for instance, seeks documents regarding the marketing and sale of sodium thiosulfate to dialysis providers by Hope and any of its affiliated entities. (JS at 91). Plaintiff objected to this RFP on confidentiality grounds (with respect to its smaller customers), and this RFP also falls into the categories relating to customer identification, information from plaintiff's foreign affiliates, and ESI. The Court is confident that the parties will be able to resolve issues arising from the Court's Order, if any, as a result of the multiple categorization of the RFPs or Interrogatories, without the need for additional Court intervention.

Plaintiff's relevance objections and defendants' responses to those objections are also separately discussed with respect to each of the other categories of requests into which the parties grouped the RFPs (as reflected in their Supplemental Memoranda) and which are reflected in the headings in this Order.

The circumstances surrounding plaintiff's prior motion to compel are different from those herein. In that instance, defendants had already agreed to produce drug formulations subject to their objections. (See ECF No. 68-1 at 73). The Court found defendants' objections regarding the overbreadth of plaintiff's requests to be well taken, and granted plaintiff's motion in part, ordering that the responsive documents be produced pursuant to certain geographical and other limitations. (ECF No. 76 at 4). In the Motion to Compel at issue herein, plaintiff has demonstrated why its drug formulations are not relevant or proportional to the needs of the case.

This applies to any RFP or Interrogatory discussed herein for which plaintiff agreed to produce documents and/or information.

As discussed elsewhere in this Order, RFP number 33 asked for plaintiff's profit and loss statements.

Although defendants appear to be including RFP numbers 1-29 in this category (Def'ts' Supp'l Mem. at 4), they specifically stated in their Motion to Compel that only RFP numbers 1-12, 16-21, and 23-29 were at issue. (MTC at 2).