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Kubicki v. Medtronic

United States District Court, District of Columbia

December 23, 2014

MEDTRONIC et al., Defendants.


JOHN M. FACCIOLA, Magistrate Judge.

Currently pending and ready for resolution are the following two motions: 1) Plaintiffs' Motion for Relief [#86] and 2) Defendants Unomedical Devices S.A. de C.V.'s and Unomedical A/S's Motion for Protective Order [#89].


The gravamen of the plaintiffs' complaint is that on September 9, 2007, Caroline suffered permanent brain damage as a result a hypoglycemic event (over delivery of insulin), caused by her use of the Medtronic MMT-522 Pump ("the 522 Pump"), a device designed to manage Type I diabetes in individuals requiring insulin therapy, in conjunction with the Paradigm Infusion Set Model MMT-396 ("the 396 Infusion Set"), a device designed to connect an insulin pump to an individual's body. Id . ¶¶ 2, 14, 15, 16, 24, 27, 37.

The plaintiffs assert six theories of liability against the defendants:[1] 1) negligence (Counts I-VI); 2) strict liability/Restatement of Torts § 402(A) (Counts VII-XII); 3) express warranties (Counts XIII-XVIII); 4) failure to warn - Restatement of Torts § 388 (Counts XIX-XXIV); 5) punitive damages (Counts XXV-XXX); and 6) damages (Count XXXI).


I. The Unsuccessful Meet and Confer

Beginning on August 15, 2014, counsel for the parties began to meet and confer to prepare for the Rule 30(b)(6) deposition of the defendants by defining the topics for those depositions. [#89-1] at 23. On September 22, 2014, the parties conferred with Judge Ketanji Jackson by telephone and she then directed them to meet and confer regarding their differences. Id . The parties did so, but were unable to reach any final agreement.

According to Medtronic, although plaintiffs previously agreed to withdraw their demand for information about "the corporate entities and individuals responsible for calculating and monitoring Medtronic's sales, market share and profits information, " they now seek to expand that topic to include "information concerning sales, market share and profits.'" [#88-3] at 19. In addition, Medtronic also contends that, although it offered to "consider a more reasonable request for adverse event information tailored to the devices and claims at issue in the case, " plaintiffs rejected its proposal and instead insisted on "all adverse events for all models of insulin pumps in the Paradigm family, and all models of Paradigm Quick-set infusion sets, for a period covering 15 years." Id. at 19-20. Finally, Medtronic contends that, although it provided plaintiffs with an additional outline of its proposal, plaintiffs did not respond and instead filed the instant motion. Id. at 20.

According to Unomedical, the parties reached agreement as to certain issues but could not agree on the definition of the following terms in the Rule 30(b)(6) deposition notices: 1) "Relevant Time Period"; and 2) "Paradigm Infusion Set." Id. at 25-26. Unomedical further contends that the parties were unable to agree as to whether the depositions would include testimony as to the following topics: 1) "Unomedical's relationship with any other entity' having any role in connection' with the [Infusion Set]"-Unomedical offered to provide testimony regarding such entities in the distribution and sale of the device (the one Caroline used) in the United States but not as to activities outside of the United States by entities other than the named defendants; 2) "Unomedical's policies and procedures for recording or memorializing communications or interactions with regulatory agencies beyond the United States"-Unomedical agreed to provide testimony as to "its procedures for memorializing communications between Unomedical and the FDA related to the design, manufacturing, and marketing" of the device (the one Caroline used) but not as to foreign regulators; and 3) "the identity of corporate entities and individuals, '... "who might calculate or monitor sales, market share, and profits not only as to the subject infusion set, but also as to other irrelevant infusion sets."[2] Id. at 26-28. At some point thereafter, the meet and confer process broke down and the instant motions were filed.

II. The Parties' Positions

As the Memorandum of Points and Authorities in Support of Plaintiffs' Motion for Relief [#86-1] and, more particularly, Plaintiffs' Reply Memorandum in Support of Motion for Relief and In Opposition to Medtronic's Cross-Motion for Protective Order [#92] make clear, plaintiffs want the Court to go much further than denominating what are the proper topics for the Rule 30(b)(6) depositions. Rather, plaintiffs seek to have the court specify the proper scope of discovery from this point on "irrespective of the mode or phase of the discovery at issue." [#92] at 2. Building on that basis, plaintiffs first want to expand the scope of discovery beyond simply information pertaining to the devices that Caroline used on September 9, 2007. Id. at 12-21.

According to plaintiffs, the predicate devices, which were first manufactured in 1999, were antecedents of the devices that Caroline used. Id. at 21. Specifically, plaintiffs contend that representations made by defendants in their submissions to the FDA, in which defendants claimed that the new devices were the substantial equivalent of predicate devices, are admissions by defendants that yield the conclusion that information about the earlier devices is relevant to or likely to lead to information relevant to the devices Caroline used. Id. at 15-21. Plaintiffs further contend that information about the successor devices is similarly discoverable. Id. at 12-21. Thus, according to plaintiffs, the scope of discovery should be fifteen years long, from 1999, when the first predicate device was introduced, to the present. Id. at 21. Finally, plaintiffs contend that the following information about the subject devices, during that same time period, is also discoverable: 1) information concerning post-manufacture and post-injury remedial events and measures; 2) information concerning defendants' communications and interactions with foreign regulatory agencies; 3) information concerning sales, market share, and profit; and 4) information concerning adverse events. Id. at 22-30.

Both Medtronic and the Unomedical protest that plaintiffs are misreading their FDA submissions and approvals and that the predicate and successor devices were different in significant ways from the two devices used by Caroline. See [#88-3] at 20-52; [#89-1] at 32-50. Rather, they insist that discovery be limited to information about the devices Caroline actually used and resist any further discovery. Id.

III. Analysis

A. Legal Standard

Rule 26 of the Federal Rules of Civil Procedure provides the following:

Unless otherwise limited by court order, the scope of discovery is as follows: Parties may obtain discovery regarding any nonprivileged matter that is relevant to any party's claim or defense-including the existence, description, nature, custody, condition, and location of any documents or other tangible things and the identity and location of persons who know of any discoverable matter. For good cause, the court may order discovery of any matter relevant to the subject matter involved in the action. Relevant ...

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