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In re Onglyza (Saxagliptin) and Kombiglyze XR (Saxagliptin and Metformin) Products Liability Litigation

United States District Court, E.D. Kentucky, Central Division, Lexington

November 5, 2019


         ALL CASES



         This matter comes before the undersigned pursuant to a referral from Judge Caldwell to handle the discovery disputes in this case. Plaintiffs filed a Motion to Compel supplemental discovery responses. [DE 349]. Defendants filed a Response [DE 363] and Plaintiffs replied [DE 365]. The Court conducted a hearing to better understand the arguments of the parties. Having reviewed the written materials as well as the arguments presented by counsel, the matter is fully ripe. Plaintiffs' Motion to Compel will be granted in part and denied in part for the reasons stated below.


         This case is a multidistrict litigation arising from allegations that the Type 2 diabetes medication saxagliptin, sold under the brand names Onglyza and Kombliglyze XR, allegedly caused heart failure and/or increased the risk of adverse cardiac events. Defendants Bristol-Myers Squibb Company (“BMS”) and AstraZeneca (“AZ”) jointly studied, developed, and made submissions to the Food and Drug Administration (“FDA”). [DE 363 Page ID# 2205]. According to Defendants, “AstraZeneca acquired BMS's interest in saxagliptin in February 2014; as part of that acquisition, BMS subsequently transferred its data from the development of saxagliptin to AstraZeneca.” [DE 363 Page ID# 2205].

         The District Court bifurcated discovery in this case to address general causation first. [DE 179]. As part of Plaintiffs' causation discovery, they requested all clinical and non-clinical (e.g., animal studies) trial documents, all pharmacovigilance documents other than the MedWatch Reports and Detailed Case Reports (DCRs), and custodial communication files for seventeen employees. Plaintiffs further requested that all documents be produced in “eCTD format” where that format is available.[1] Defendants argued that much of this information had been produced; they did not understand or know what additional information Plaintiffs were seeking; the information was not readily available in eCTD format and did not have to be produced that way regardless; the clinical and non-clinical trials requested were irrelevant; the request for custodial files was disproportionate to the needs of general causation discovery. [See, generally, DE 363]. Plaintiffs respond that the data received to date is “unusable” because it is missing metadata and parent/child information. Both parties highlighted the delays of the other, as well as the numerous meetings they have conducted in (failed) efforts to resolve the discovery disputes without judicial interference.

         At the hearing, the Court questioned the parties, taking each of the three broad categories- clinical/non-clinical trials, pharmacoviligence, custodial files-in turn. Both parties' positions at the hearing were not wholly consistent with their positions in their briefs, although this appeared to be due to the parties' trying to resolve the dispute. The parties were able to agree on some points at the hearing. The Court's rulings on the contested items are below.

         II. ANALYSIS

         Rule 26(b)(1) allows discovery of “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). In the discovery context, relevance is “construed broadly to encompass any matter than bears on, or that reasonably could lead to other matter that could bear on any party's claim or defense.” Albritton v. CVS Caremark Corp., 2016 WL 3580790 (W.D. Ky. June 28, 2016). Keeping in mind the balance between allowing broad discovery and the proportional discovery needs at the general causation phase of this litigation, the Court finds as follows:

         A. Clinical and Non-Clinical Trials

         1. Non-clinical Data

         At the hearing, Defendants stated they have identified 15 non-clinical studies that appear to be responsive to Plaintiffs' request for production of documents 13-24 and relevant to the issues in this lawsuit. Defendants have identified over 100 non-clinical studies involving saxagliptin, most of which did not study heart failure. To the extent Defendants have not produced any of these 15 studies and/or their supporting, underlying data, they must do so as soon as practicable. The Court will not require Defendants to produce additional non-clinical studies and data beyond the 15 Defendants identified. Defendants may redact documents as appropriate; however, because these are not clinical trials involving patients, the Court expects these redactions will be very limited. It appeared that the parties reached an agreement at the hearing consistent with this ruling, but in an effort to avoid further dispute on this point, the Court grants the Motion to Compel as to the 15 non-clinal studies Defendants identified.

         2. Clinical Trial Data

         The parties disagree on two points regarding clinical trial data: (1) what should be produced; ...

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