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In re EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation

United States District Court, D. Kansas

June 11, 2018

IN RE EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation This Document Applies to Alls

          MEMORANDUM AND ORDER

          Teresa J. James U.S. Magistrate Judge.

         This matter is before the Court on Class Plaintiffs' Amended Motion to Compel Compliance with Subpoena Directed to Non-Party Humana, Inc. (ECF No. 292). Pursuant to Fed.R.Civ.P. 26 and 45, Class Plaintiffs seek an order requiring non-party Humana, Inc. to search for and produce documents responsive to Plaintiffs' subpoena served on December 11, 2017. Humana opposes the motion. As set forth below, the Court will grant Plaintiffs' motion.

         I. Relevant Background

         On December 11, 2017, Plaintiffs served a Rule 45 subpoena on Humana. Under Rule 45(d)(2)(b), Humana's deadline for objections was 14 days after service of the subpoena.[1] On December 22, 2017, counsel for Humana contacted Plaintiffs' counsel to request an extension of the response and production deadlines. Plaintiffs agreed to an extension as long as Humana committed to begin producing responsive materials by January 31, 2018. Humana served its objections on January 17, 2018, and counsel conferred five days later. Plaintiffs state that, during the January 22 telephone conference, Humana's counsel confirmed the January 31 rolling production start.[2] Humana does not dispute the statement, but points to a January 29, 2018 telephone conversation during which Plaintiffs agreed to a delay in the start of production in light of Humana's concerns about its HIPAA obligations and members' privacy rights.[3]

         Counsel continued to communicate, but as of the date Plaintiffs filed the instant motion, Humana had produced no responsive documents. On March 1, 2018, Humana produced 17 documents relating to six subpoena requests, with no indication whether additional documents exist that are responsive to those requests. Humana has not produced any documents in response to another six requests, nor has it indicated when it will do so.[4]

         The parties have engaged in extensive written and oral communication regarding the subpoena. Based on the parties' efforts, the Court finds they have complied with the requirements of D. Kan. R. 37.2.

         II. Summary of the Parties' Arguments

         Plaintiffs assert this Court has jurisdiction to decide this motion, while Humana contends the motion should be heard in the Western District of Kentucky, the district that includes the place for compliance. Regarding the merits, Plaintiffs contend all their requests are relevant and Humana should be compelled to produce responsive documents. Humana stands by its objections, arguing that collectively they demonstrate the subpoena imposes undue burden and expense on Humana.

         III. Legal Standard

         In issuing a subpoena, a party must “take reasonable steps to avoid imposing undue burden or expense on a person subject to the subpoena.”[5] Non-parties responding to Rule 45 subpoenas generally receive heightened protection from discovery abuses.[6]

         Federal Rule of Civil Procedure 45 governs both motions to compel compliance with and motions to quash a subpoena served on a non-party.[7] Under Rule 45(d)(2)(B), if the entity commanded to produce documents serves written objections to the subpoena, the serving party may seek compliance by filing a motion to compel production of the documents. If the non-party wishes to challenge the subpoena, it does so by filing a motion to quash. Rule 45(d)(3) sets forth circumstances under which a court must quash or modify a subpoena, including when the subpoena “requires disclosure of privileged or other protected matter, if no exception or waiver applies, ” and when the subpoena “subjects a person to undue burden.”[8] The rule also allows a court discretion to quash or modify a subpoena that requires the disclosure of a “trade secret or other confidential research, development, or commercial information.”[9]

         “The scope of discovery under a subpoena is the same as party discovery permitted by Fed.R.Civ.P. 26.”[10] In other words, the relevancy standards set forth in Rule 26 define the permissible scope of a Rule 45 subpoena. Relevancy is to be “construed broadly to encompass any matter that bears on, or that reasonably could lead to other matter that could bear on” any party's claim or defense.[11] Information still “need not be admissible in evidence to be discoverable.”[12] When the discovery sought appears relevant, the party resisting discovery has the burden to establish the lack of relevancy by demonstrating that the requested discovery (1) does not come within the scope of relevancy as defined under Fed.R.Civ.P. 26(b)(1), or (2) is of such marginal relevancy that the potential harm occasioned by discovery would outweigh the ordinary presumption in favor of broad disclosure.[13] Conversely, when the relevancy of the discovery request is not readily apparent on its face, the party seeking the discovery has the burden to show the relevancy of the request.[14] Relevancy determinations are generally made on a case-by-case basis.[15]

         IV. Jurisdiction

         Plaintiffs assert that as the MDL transferee court, this Court has jurisdiction to rule on their motion to compel. Humana disagrees and although it does not say so directly, hints that the authorities Plaintiffs cite are no longer good law after the 2013 amendment to Rule 45. Prior to the amendment, Rule 45 required that subpoenas issue from the district where compliance was required.[16] The issuing court retained the authority to modify or quash the subpoena.[17] After the 2013 amendment, however, subpoenas must be issued from the court where the action is pending, [18] but the authority to quash or modify the subpoena remains with “the court for the district where compliance is required.”[19] Although transfer of a motion to quash or other subpoena-related motion from the court where compliance is required to the issuing court is permitted in certain circumstances, any such transfer is not initiated by the issuing court.[20]

         The language in Rule 45 which assigns enforcement to “the court for the district where compliance is required” refers only to orders quashing or modifying a subpoena.[21] It is no surprise that Rule 45 makes no mention of where a party must file a motion to compel compliance with a Rule 45 document subpoena, as that is determined by another rule. Rule 37(a), which applies to motions for an order compelling disclosure or discovery, directs that “[a] motion for an order to a nonparty must be made in the court where the discovery is or will be taken.”[22] This language is not new, but has been part of Rule 37 since its inception. Were the Court to decide this issue by looking only to the Federal Rules of Civil Procedure, the Court would deny Plaintiffs' motion without prejudice to its refiling in the Western District of Kentucky.

         However, the basis for ruling that an MDL transferee court has authority to rule on a motion to compel in this situation (where a Rule 45 subpoena is issued by the MDL court but compliance is sought in another district) is not Rule 45 or Rule 37. Instead, courts find authority in 28 U.S.C. § 1407, the statute authorizing the MDL Panel to transfer civil actions involving one or more common questions of fact for coordinated pretrial proceedings.[23] Section 1407(b) expressly empowers an MDL court to “exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions.”[24] The statute's remedial purpose of eliminating the potential for conflicting contemporaneous pretrial rulings would be frustrated if the MDL court could not entertain motions to compel. In this case, Class Plaintiffs have served subpoenas on numerous non-parties, each containing the same requests. To enable this Court to fully exercise its power under § 1407, it is necessary to assume enforcement powers in relation to these subpoenas. Doing so is also consistent with the transfer order in this case wherein the MDL panel noted that “centralization . . . will eliminate duplicative discovery [and] prevent inconsistent pretrial rulings.”[25] As the Court presiding over the MDL, this Court has authority to decide the motion to compel.

         V. Relevancy

         Although Humana does not object to any of the requests on the basis of relevancy, the Court finds it appropriate to examine the relevancy of the requests to afford Humana the heightened protection a non-party deserves. Construing relevancy broadly, as the standard directs, the Court finds Plaintiffs' document requests clearly encompass matters that bear on their claims in this case. This is an antitrust, civil RICO, and consumer-protection class action brought on behalf of those who purchased or used the EpiPen, an epinephrine auto-injector (“EAI”). The Complaint's allegations make relevant a number of topics for discovery, including the EAI market, EAI device coverage and formulary placement or exclusion, usage, claims, consumer costs, demand and competitive conditions, and EAI-related payments and costs along the distribution and pharmaceutical supply chain.[26] As Plaintiffs describe it, “[r]elevant discovery subjects also include documents and information related to EAI manufacturer marketing, educational and presentation materials, concerning their and competitor EAI devices as it is alleged that Mylan engaged in a massive misinformation campaign concerning EpiPen and competitor EAIs directed at the healthcare industry and consumers.”[27]

         Given Plaintiffs' allegations, the Court finds relevant the categories of requests included in Plaintiffs' subpoena. As Plaintiffs describe their requests, they include: (i) rebate and formulary information, including agreements, communications and other deliberative materials relating to those agreements; and (ii) documents concerning consideration paid or received related to the marketing, distribution, or sale of any EAI Drug Device. See Ex. 1, Req. No. 1 (documents regarding rebate or incentive agreements); id., Req. No. 4 (consideration related to marketing, distribution or sale of EAI Drug Devices); id., Req. No. 7 (documents concerning agreements with EAI Drug Device Manufacturers regarding sale, reimbursement, formulary placement, etc.); and id., Req. No. 14 (decision or consideration to include or exclude any EAI Drug Device from formularies).[28]

         Having found the document requests facially relevant, the Court turns to Humana's objections.

         VI. Humana's objections

         Citing Rule 45's directive that courts must enforce the serving party's obligation to take “reasonable steps to avoid imposing undue burden or expense, ”[29] Humana argues it should be protected from responding to the subpoena. First, Humana argues Plaintiffs' requests are facially overbroad because they seek “any” or “all” documents “concerning” broad categories of items in the possession of those who have ever had a “joint venture or partnership relationship” with affiliates of Humana.[30]

         Humana's objections to the individual requests are boilerplate; they state an objection without offering an explanation. In response to Humana's boilerplate objections, Plaintiffs point out that Humana recognizes the documents Plaintiffs seek are uniquely within Humana's possession or control.[31] In addition, Plaintiffs have provided Humana with a specific list of data fields to assist in data production, narrowed the relevant time period at Humana's request, [32] and made suggestions where responsive documents may ...


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