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From Health Law Daily, December 29, 2014

Witnesses, not lawyers, must answer technical questions

By Michelle L. Oxman, J.D., LL.M.

Medtronic and its codefendant must produce witnesses to explain the differences and similarities of earlier and later models to the insulin infusion device that allegedly injured a patient. The companies also must answer questions about their procedures for recording and memorializing communications with the FDA and other regulatory agencies and whether they are aware of adverse events that are not reported in the FDA’s public database. The plaintiff’s request for documents relating to all infusion devices in the product line over a 15-year period was denied, however (Kubicki v. Medtronic, December 23, 2014, Facciola, J.).

The device and the injuries. Caroline Kubicki used a Medtronic MMT-522 insulin pump in conjunction with the Paradigm Infusion Set Model MMT-396 to manage her Type I, i.e., insulin-dependent diabetes. In 2007, she sustained permanent brain damage when the device delivered too much insulin. She sued Medtronic and Unomedical Devices S.A. (Defendants), the manufacturers, for negligence, breach of express warranties, strict liability, and punitive damages.

The legal dispute. Kubicki claimed that: (1) Defendants were aware of adverse events caused by defects in the Paradigm Infusion Set and the insulin pump but did nothing to prevent further injuries; (2) the model she used was a successor to earlier models first marketed in 1999; and (3) under 21 U.S.C. §360e, Defendants were allowed simply to notify the FDA their intent to market a new device similar to the previously approved device and were not required to obtain approval of her device by proving that the model she used were safe and effective. Therefore, she sought discovery concerning earlier and later models of the Paradigm Infusion. The Defendants claimed that the model Kubicki used was different from earlier and later models, so that discovery should be limited to the one Kubicki used.

Kubicki’s argument extended not only to the depositions involved in the current discovery request, but also to Defendants’ obligations to produce document concerning all of the Paradigm products from 1999 to the present. She also sought financial information related to her claim for punitive damages.

The court’s ruling. The court limited its ruling to the pending depositions. It reasoned that it could not measure either the burden on the Defendants or Kubicki’s need for the information she sought without a particular discovery request. First, Defendants must respond to Kubicki’s questions about all earlier and later models. The similarities and differences from Kubicki’s device were scientific and technical matters; therefore, Kubicki was entitled to explanations from the persons who evaluated the scientific and technical issues. Kubicki also was entitled to answers to her questions about how the manufacturers documented their communications with the FDA and other regulatory agencies, both foreign and domestic. Once she had that information, she could request documents relevant to the issues; she would not be allowed to request every communication between the Defendants and all regulatory agencies over a 15-year period.

To the extent that information about adverse events involving the devices was available in the FDA’s MAUDE database, Kubicki should obtain it there first. She could, however, ask Defendants whether they were aware of any incidents not in the database. The court rejected the manufacturers’ argument that they were protected from the use of adverse event reports in court under 21 U.S.C. §360i(b). The court noted that the limitation applied to reports made by professionals and facilities that used the devices, not to reports by manufacturer, which were required by 21 U.S.C. §360i(a). However, the court noted, 21 C.F.R. Sec. 20.63 required the manufacturers to redact any information that would reveal the identity of the user who made the report. Finally, the court would review financial information in chambers, but would not allow the plaintiff to have it unless and until the court determined that punitive damages were at issue .

The case number is 12-734 (KBJ/JMF).

Attorneys: Adam R. Leighton (Cohen & Cohen, PC) for John Kubicki. Eric Lawrence Alexander (Reed Smith LLP) for Medtronic, Inc., Medtronic Diabetes, and Medtronic MiniMed, Inc. Kelly Marie Lippincott (Carr Maloney PC), and Leslie J. Suson (Thompson Hine LLP) for Unomedical A/S, and Unomedical Devices SA De CV.

Companies: Medtronic; Unomedical Devices S.A. de C.V.; Unomedical A/S; Medtronic Diabetes; Medtronic MiniMed, Inc.

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