SANDOZ, INC., et ano., Plaintiffs, v. UNITED THERAPEUTICS CORP., et ano. Defendants Civil Action No. 19-10170 United States District Court, D. New Jersey Filed June 10, 2021 Counsel Steven L. Penaro, Jenny R. Kramer, Alston & Bird Llp, New York, NY, Thomas D. Pease, Quinn Emanuel Urquhart & Sullivan, LLP, New York, NY, for Plaintiff. Stephen M. Orlofsky, Michael Ray Darbee, Blank Rome LLP, Princeton, NJ, for Defendant. Linares, Jose L., United States District Judge (Ret.) OPINION AND ORDER OF THE SPECIAL DISCOVERY MASTER REGARDING DEFENDANT'S MOTION TO COMPEL PLAINTIFFS TO PRODUCE ADDITIONAL PUMP AND CARTRIDGE DISCOVERY *1 This matter comes before the Special Master by way of Defendant United Therapeutics Corp.’s Motion to Compel Plaintiffs Sandoz, Inc. and RareGen, LLC (now Liquidia PAH)[1] to produce a discrete subset of documents from March 5, 2021 to April 2, 2021. (See Defendant UTC's May 17, 2021 Letter Brief (“Def. Br.”)). On May 25, 2021, Plaintiffs opposed Defendant's Motion. (See Plaintiffs’ Joint May 25, 2021 Opposition Letter Brief (“Pl. Br.”)).[2] The Special Master has reviewed the submissions and relevant controlling law, and, for the reasons set forth below, hereby GRANTS Defendant's Motion. I. FACTS The Special Master presumes the parties’ familiarity with the facts and procedural posture of this matter. As such, the Special Master will only recite the facts pertinent to the subject dispute. Defendants seek certain documents from March 5, 2021 to March 30, 2021 that relate to Plaintiffs’ recent FDA approval of Plaintiffs’ cartridge. In making this demand, Defendant argues that a central issue in this matter is Plaintiffs’ claim for damages based on the fact that “they came to market without securing a supply of cartridges for the CADD-MS 3.” (Def. Br. at 1 (citing ECF No. 1 ¶¶ 51-52)). That claim is based on the assertion the Defendant did not permit Plaintiffs to utilize Defendant's own cartridges. (Id.). As such, and as Judge Martinotti recognized, inquiry into Plaintiffs’ efforts to research and develop their own cartridge is central to the resolution of this case. (See Preliminary Injunction Hearing Transcript at 12:20-23). Accordingly, discovery into Plaintiffs’ conduct in relation to the development of their own cartridges was appropriate. Recognizing this need, Defendant sought discovery pertaining to Plaintiffs’ cartridge development and approval process. (See generally Def. Br. at 2) (explaining the knowledge Defendant has regarding this process). For example, Defendant is aware that Plaintiffs filed an application for a cartridge with the FDA [Redacted] However, on March 30, 2021, the FDA finally approved Plaintiffs’ cartridge. (Id. (citing Ex. 5 (March 30, 2021 Liquidia Press Release))). Upon learning of the cartridge approval, Defendant sought information as it pertains to this central issue. (Id.). Specifically, Defendant desired to learn “[w]hat transpired between March 5, 2021 and March 30, 2021 to get Plaintiffs’ cartridge over the final FDA hurdles.” (Id.). Plaintiffs objected to Defendant's request asserting that same was untimely because the request was beyond the discovery end date of April 2, 2021 and that Defendant has taken conflicting positions regarding the temporal limitations of discovery in this matter. (See generally Pl. Br.). *2 Hence, the parties were at an impasse, causing Defendant to file the within application. After careful consideration, and for the reasons set forth below, the Special Master grants Defendant's Motion. II. LEGAL STANDARD Rule 26 explains that “[p]arties may obtain discovery regarding any matter, not privileged, which is relevant to the subject matter involved in the pending action.... It is not ground for objection that the information sought will be inadmissible at the trial if the information sought appears reasonably calculated to lead to the discovery of admissible evidence.” Fed. R. Civ. P. 26(b)(1). The broad scope of the discovery rules and liberal interpretation given them by Courts shows that Congress realized that a “[m]utual knowledge of all the relevant facts gathered by both parties is essential to proper litigation.” Hickman v. Taylor, 329 U.S. 495, 507-08 (1947) (emphasis added). III. ANALYSIS The arguments pertaining to this motion are straightforward. Defendant believes it is entitled to supplemental document discovery related to the changes that led the FDA to finally approve Plaintiffs’ cartridge. (See generally Def. Br.). In making this argument, Defendant explains that the discovery it seeks is essentially a continuation of the discovery that has already been exchanged. (Def. Br. at 2). Moreover, Defendant explains that the recent developments surrounding the approval of Plaintiffs’ cartridge is crucial to the disposition of this action. (Id.). As such, Defendant claims it will be prejudiced if it is not allowed to fully understand all of Plaintiffs’ efforts relating to the cartridge approval. (Id.). On the other hand, Plaintiffs assert that Defendant's request is out of time since same was made after the discovery period expired. (See generally Pl. Br.). Pointing to Rule 37, Plaintiffs begin by arguing that Defendant's motion is inappropriate since it was made after the close of discovery. (Id. at 1). Plaintiffs also claim Defendant had ample opportunity to explore this topic, but did not do so. (Id. at 1-2). Along the same lines, Plaintiffs claim Defendant has failed to show good cause for reopening discovery. Finally, Plaintiffs argue that Defendant's current position conflicts with prior positions Defendant has taken because previously Defendant sought to limit document discovery to information generated before April 2020. (Id. at 3). The Special Master agrees with Defendant in this circumstance. While Defendant's request and motion may technically be beyond the discovery deadline, the reality is the discovery sought is a continuation of discovery that has already been exchanged between the parties. A brief review of the discovery proves this true, as Defendant has been fully apprised of all of Plaintiffs’ efforts in connection with the cartridge approval process up to March 5, 2021. [Redacted] As such, it only seems fair that Defendant be allowed to learn what transpired between March 5, 2021 and March 30, 2021 that finally persuaded the FDA to approve Plaintiffs’ cartridge. This conclusion is further bolstered by the important role Plaintiffs’ efforts in securing an appropriate cartridge so they can bring their drug to market plays in the overall resolution of this case. Indeed, Plaintiffs’ access, or lack thereof, to an appropriate cartridge to administer the drug is a crucial issue that must be fleshed out thoroughly if this action is going to be properly presented to the fact finder. Accordingly, providing Defendant with all discovery pertaining to same is consistent with the purpose of the discovery rules. *3 It should be noted that the Special Master is in no way ordering that discovery be reopened. Rather, this Order is limited in its scope and is designed to assure that Defendant has all the necessary facts that it is entitled to. Finally, the Special Master is not persuaded by Plaintiffs’ argument that Defendant has taken conflicting positions regarding the temporal limitations of discovery at different points in the case. Simply, Defendant previously explained that it applied the April 2020 cutoff date in order for it to comply with the substantial completion date of July 24, 2020. By no means did Defendant also agree that by applying the April 2020 cutoff date that it would also no longer be entitled to discovery pertaining to late-breaking events that go to one of the main issues raised by Defendant in this case. Thus, for the foregoing reasons, the Special Master grants Defendant's Motion to Compel. IV. ORDER For the foregoing reasons, it is on this 8th day of June, 2021, ORDERED that Defendant's Motion to Compel Plaintiffs’ to Produce Cartridge Related Discovery from March 5, 2021 to March 30, 2021 is hereby GRANTED; and it is further ORDERED that Plaintiffs shall produce the supplemental discovery pertaining to the approval of the their cartridge within seven days; and it is further ORDERED that, in the event this additional discovery reveals information that necessitates supplemental expert reports, either party may, upon good cause, file a letter request to the Special Master to supplement its expert reports. SO ORDERED. Footnotes [1] Plaintiff RareGen officially changed its name to Liquidia PAH, LLC. (ECF Nos. 294, 295). [2] The Special Master notes that both Defendant and Plaintiffs submitted additional unauthorized submissions. (See Defendants May 26, 2021 email; Plaintiffs’ May 26, 2021 responsive email). The Special Master will consider both of these submissions, but cautions the parties in continuing to make submissions of this nature in the future. Thus, going forward, any party interested in providing supplemental briefing shall first seek the Special Master's approval.