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

United States District Court, D. Kansas

May 31, 2018

IN RE: EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation This Document Applies to All Cases UNITED HEALTHCARE SERVICES, INC., Plaintiff,
CONSUMER CLASS PLAINTIFFS, IN RE EpiPen Epinephrine Injection, USP Marketing, Sales Practices and Antitrust Litigation



         This matter is before the Court on (1) Class Plaintiffs' Motion to Compel Compliance with Subpoena Directed to Non-Party United Healthcare Services, Inc. (ECF No. 206) in No. 17-md-2785-DDC-TJJ, and (2) United Healthcare Services, Inc.'s Motion to Quash Plaintiff's Rule 45 Subpoena (ECF No. 1) in No. 18-mc-205-DDC-TJJ. Pursuant to Fed.R.Civ.P. 45, Class Plaintiffs seek an order requiring non-party United Healthcare Services, Inc. (“United”) to search for and produce documents responsive to Plaintiffs' subpoena served on December 11, 2017. United opposes the motion. Also pursuant to Rule 45, United seeks an order quashing Class Plaintiffs' subpoena. Class Plaintiffs oppose United's motion. As set forth below, the Court will grant Plaintiffs' motion and deny United's motion.

         I. Relevant Background

         On December 8, 2017, Plaintiffs issued a Rule 45 subpoena to United and served it three days later. Under Rule 45(d)(2)(b), United's deadline for objections was 14 days after service of the subpoena.[1] On December 18, 2017, counsel for United contacted Plaintiffs' counsel to request an extension of the deadlines to serve objections and respond to the subpoena. Counsel agreed to a January 11, 2018 deadline for objections, and to meet and confer ahead of that date to identify potentially responsive documents. Counsel conferred by telephone on January 2 and 10, 2018, but were unable to reach a compromise on any of the requests. On January 11, 2018, United served its objections on Plaintiffs' counsel. Counsel conferred again by telephone on January 25, 2018, exchanged letters in the following days, and continued to be in touch by both email and telephone. On February 7, 2018, United filed a motion to quash the subpoena in the U.S. District Court for the District of Minnesota.[2] On February 14, 2018, Plaintiffs moved to transfer the motion to quash to this district and filed the instant motion. On March 5, 2018, with United's consent, the Minnesota District Court granted Plaintiffs' motion and transferred United's motion to quash to this district.[3]

         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

         The parties raise symmetrical issues and arguments in United's motion to quash and in Plaintiffs' motion to compel.[4] Plaintiffs contend their subpoena is reasonable and narrowly tailored, and that the Court should overrule United's conclusory and boilerplate objections and require United to produce responsive documents. United objects that complying with the subpoena would impose undue burden and expense on United, the latter of which should be remedied by requiring Plaintiffs to pay United's cost of compliance. United also objects to the subpoena as premature and unnecessary.[5]

         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.”[6] Non-parties responding to Rule 45 subpoenas generally receive heightened protection from discovery abuses.[7]

         Federal Rule of Civil Procedure 45 governs both motions to compel compliance with and motions to quash a subpoena served on a non-party. 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. Relevancy

         Although United 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 United 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. Plaintiffs allege Defendants created and exploited an EpiPen monopoly by providing aggressive rebates and incentives to pharmacy benefits managers (PBM), including Optum, to exclude EpiPen competitors from drug formularies. Plaintiffs describe PBMs as the gatekeepers between drug and medical supply manufacturers on the one hand, and health insurers and patients on the other. Plaintiffs allege Mylan paid to keep other epinephrine auto- injector (EAI) competitors out, with the result being harm to the competitive process to the detriment of both competitors and consumers.

         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).[16]

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

         V. United's objection that the requests are overbroad and unduly burdensome

         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, ”[17] United argues it should be protected from responding to the subpoena. First, United contends the subpoena is premature because Plaintiffs may obtain the subpoenaed information during discovery between the parties to this lawsuit, thereby obviating the need for Rule 45 discovery. The Court rejects United's characterization of the subpoena as calling for discovery that “will likely duplicate evidence” Plaintiffs will receive from parties.[18] To the extent Plaintiffs seek United's internal communications and deliberations, as well as documents, agreements, and communications with non-party manufacturers, there would be no duplication. In addition, United is not in a position to know what other parties will produce, nor whether a particular document may differ in version or have additions or omissions when coming from two different sources. As a result, the authority United cites is inapposite.

         United's second argument is similar, suggesting it would suffer undue burden by having to respond to a subpoena that seeks information the parties to the litigation possess. United concedes, however, that Plaintiffs have agreed to limit their requests to documents Plaintiffs are not able to obtain from another party to this litigation. Because Plaintiffs are seeking only United's internal documents, United has not demonstrated complying with Plaintiffs' requests will cause undue burden.

         United next argues that the subpoena is overbroad by virtue of its definitions, which it asserts “would require United to identify and search at least 500 corporate entities (including legacy entities and acquisitions for which gathering electronic information can be difficult) for vast amounts of epinephrine-related information from an eleven-year period.”[19] United also objects to each individual request, repeatedly stating that the requested information is more readily available from the parties to the litigation, and that the requests are overly broad, unduly burdensome, vague, ambiguous, prohibitively expense, and excessively time-consuming.[20] In addition, United objects that the following words and phrases are vague and ambiguous: “actual or potential demand, ” “competitive conditions, ” “understanding, ” “other data, ” “presentation(s), ” “educational material, ” “marketing material, ” “classification, ” “misclassification, ” “budgets, ” “projections, ” “forecasts, ” “plans, ” “agreements, ” “guidelines, ” “policies, ” “standards, ” and “clinical or financial analysis or recommendations.”[21]

         “Whether a subpoena imposes an undue burden upon a respondent raises a case-specific inquiry. It turns on such factors as relevance, the need of the party for the documents, the breadth of the document request, the time period covered by it, the particularity with which the documents are described and the burden imposed.”[22] A court is to balance the relevance of the information sought against the burden imposed.[23] The Goodyear Tire & Rubber Co. case goes on to describe the concept of relevancy:

Relevancy is broadly construed, and a request for discovery should be considered relevant if there is “any possibility” that the information sought may be relevant to the claim or defense of any party. A request for discovery should be allowed “unless it is clear that the information sought can have no possible bearing” on the claim or defense of a party. When the discovery sought appears relevant on its face, the party resisting the discovery has the burden to establish the lack of relevance by demonstrating that the requested discovery (1) does not come within the broad scope of relevance as defined under Rule 26(b)(1), or (2) is of such marginal relevance that the potential harm the discovery may cause would outweigh the ...

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