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In re Epipen Epinephrine Injection, USP Marketing, Sales Practices and Antitrust Litigation

United States District Court, D. Kansas

June 13, 2018

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



         This matter is before the Court on Class Plaintiffs' Motion to Compel Compliance with the Subpoena Directed to Non-Party MedImpact Healthcare Systems, Inc. (ECF No. 276). Pursuant to Fed.R.Civ.P. 26 and 45, Class Plaintiffs seek an order requiring non-party MedImpact Healthcare Systems, Inc. Inc. to search for and produce documents responsive to Plaintiffs' subpoena served on December 11, 2017. MedImpact opposes the motion. As set forth below, the Court will grant in part and deny in part Plaintiffs' motion.

         I. Relevant Background

         On December 11, 2017, Plaintiffs served a Rule 45 subpoena on MedImpact. Under Rule 45(d)(2)(b), MedImpact's deadline for objections was 14 days after service of the subpoena.[1] On January 9, 2018, counsel for MedImpact served responses and objections to the subpoena, and twenty-two days later MedImpact served its first rolling production of documents.[2]

         Counsel held two meet and confer telephone sessions on January 23 and February 20, 2018. In addition to the January 31 production, MedImpact agreed to provide Plaintiffs a reasonable timeline in which it would complete production, and to produce remaining Committee Minutes no later than February 27, 2018. With a February 23 deadline to file a motion to compel, Class Plaintiffs and MedImpact discussed a possible agreement to extend the date. MedImpact agreed not to oppose an extension of time for Plaintiffs to challenge MedImpact's actual production, but would not agree to an extension of Plaintiffs' deadline regarding MedImpact's objections.[3]

         In their motion, Plaintiffs state their hope that MedImpact's forthcoming production would resolve the parties' disputes. MedImpact takes the position that the instant motion is not ripe because they have continued to produce documents, yet they stand by their objections. Since the time briefing on this motion concluded, MedImpact and Plaintiffs have not resolved their differences, as evidenced by Plaintiffs' repeated unopposed motions to extend their deadline to seek to compel MedImpact's production.[4] The Court finds it appropriate to rule on the instant motion without further delay. 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

         Because this motion is limited to challenges to MedImpact's objections, Plaintiffs' argument focuses only on MedImpact's response to the subpoena. Plaintiffs assert MedImpact's objections contain boilerplate and overly broad objections. MedImpact contends this Court lacks jurisdiction to decide this motion. Regarding the merits, MedImpact stands by its objections, arguing that collectively they demonstrate the subpoena imposes undue burden and expense on MedImpact.

         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. MedImpact disagrees and relies on arguments made by other subpoenaed non-parties that have challenged this Court's jurisdiction absent transfer from the district in which compliance is sought. Presumably, MedImpact relies on changes to Federal Rule of Civil Procedure 45 brought about by the 2013 amendment to the rule. 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 district in which compliance is requested.

         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

         MedImpact objects to several requests on relevance grounds, arguing Plaintiffs have the burden to demonstrate how the requests are not objectionable. 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 point out, Mylan has also issued a subpoena to MedImpact, indicating Mylan's belief that MedImpact possesses documents relevant to claims and/or defenses in this case. MedImpact is a pharmacy benefit manager (PBM), entities which Plaintiffs allege entered into rebate and kickback agreements with Mylan to corner the U.S. market for EAI devices and defraud the public regarding the pricing of the EpiPen. Plaintiffs contend “[t]hese PBMs exerted influence in their role as insurance-industry middle-men to dictate the success or failure of certain drugs, including EpiPen and harmed the competitive process to the detriment of competitors and consumers alike who are entitled to the benefits of robust and fair competition.”[27] Accordingly, Plaintiffs argue, MedImpact possesses documents relevant to the claims and defenses in this case.

         Given Plaintiffs' allegations, the Court finds relevant the categories of requests included in Plaintiffs' subpoena. As Plaintiffs describe these identical requests in arguing another motion to compel, the categories are as follows:

(i) EAI-related incentives and rebates, EAI formulary placement and decisions, and attendant EAI-related incentive, consideration and cost data and EAI related budgeting, plans and forecasting (Req. Nos. 1, 4, 7, 8, 10, 13 and 14); (ii) the EAI market, and EAI competitive conditions and demand (Req. Nos. 5 and 6); (iii) EAI-related marketing and other presentation materials (Req. No. 11); (iv) and documents sufficient to identify [United]'s employees and divisions with responsibility concerning EAI-related decisions (Req. No. 9). The Subpoena also seeks documents provided to any governmental entity investigating or conducting an EAI or EAI market-related inquiry (including documents concerning Mylan's misclassification of its EAI devices as non-innovator/generic drugs under Medicaid's Medical Drug Rebate Program) (Req. Nos. 2, 3 and 12).[28]

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

         VI. MedImpact'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] MedImpact argues that its objections to the subpoena's definitions and instructions, as well as its general and specific objections to document requests, reveal how complying with the subpoena would cause undue burden. In response to Plaintiffs' contention that its objections are boilerplate, MedImpact points to two objections it posed to Plaintiffs' definitions which are not conclusory but contain explanation. The first is MedImpact's objection to the definition of “you” and “your, ” which MedImpact states is so broadly written that it cannot identify all the individuals and entities within the definition's scope. The second is the same objection raised in response to Plaintiffs' definition of “Amedra, ” “Mylan, ” “Pfizer, ” “Sanofi, ” and “Shionogi.”

         Plaintiffs do not address these two objections, nor do they indicate they have conferred with MedImpact about this issue. The Court agrees that the definition of “you” and “your” is overly broad insofar as it “purport[s] to bind persons and entities other than MedImpact Healthcare Systems, Inc., and . . . seek[s] documents not within MedImpact's possession, custody or control.”[30] Likewise, the definitions of the five named companies are overly broad by purporting to include within their scope other entities and persons that MedImpact would have no means of being able to identify. The Court sustains MedImpact's objections that these definitions are overly broad. When the words appear in the subpoena requests, “you” and “your” shall refer to MedImpact Healthcare Systems, Inc.; “Amedra” shall refer to Amedra Pharmaceuticals LLC; “Mylan” shall refer to Mylan, N.V., Mylan Inc., and Mylan Specialty, L.P.; “Pfizer” shall refer to Pfizer, Inc., King Pharmaceuticals, Inc., and Meridian Medican Technologies, Inc.; “Sanofi” shall refer to Sanofi-Aventis U.S. LLC; and “Shionogi” shall refer to Shionogo Inc.

         Putting aside for the moment that MedImpact has produced documents responsive to five of the fourteen requests, confirmed it has no documents responsive to two others, and made four supplemental productions after filing its response to the instant motion, the Court is not persuaded by MedImpact's remaining objections on grounds that Plaintiffs' requests are overly broad, unduly burdensome, vague, and ambiguous. The Court agrees that MedImpact's objections on those grounds are boilerplate; they state an objection without offering an ...

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