District of Nebraska Ruling on Motion to Compel ESI in Medical Device Product Liability and Negligen
Last week in Beller v. Colopast A/S, 8:16-CV-09, 2018 U.S. Dist. LEXIS 135928 (D. Neb. Aug. 13, 2018), Magistrate Judge Michael D. Nelson granted in part the Plaintiff's Motion to Compel Defendants' Discovery Answers. The product liability and negligence action concerned a Colopast device called Virtue which is designed to treat urinary incontinence.
The Motion to Compel included a request for the Defendants to produce the search terms, date ranges, and custodians used in their ESI review, and then conduct a search using terms, date ranges, and custodians that the two parties agreed to.
Magistrate Nelson faulted the Plaintiffs for failing to conduct an in person meet & confer with the Defendants on the disputed discovery issues (they only exchanged correspondence and participated in an informal telephone conference with the court) and noted that, "Failure to show personal consultation as required by NECivR7 .1(i) is grounds alone to deny a motion to compel." Id. at *11. (The cited rule is from the District Court of Nebraska Civil Rules.) Nevertheless the Court chose to construe correspondence from the Plaintiffs as an attempt to resolve the discovery dispute before filing the motion to compel. Its consideration of the motion to compel was limited to the issues raised in the Plaintiffs' letter.
The Court ordered the Defendants to disclose their search terms, date ranges, and custodians, and instructed to the parties to meet in an ESI discovery conference to select parameters for a new search. The Court set the date range for the review itself. It begins at the date Colopast began developing the medical device and ends on the date on which it was implanted into Beller.
The Court ruled that the Plaintiffs' request for proposed preclinical and clinical studies was not burdensome. The Plaintiffs made the argument that such information would show what Colopast should have done before marketing the device. The Plaintiffs requested information on the Defendants' procedures for the collection, evaluation, and dissemination of adverse event reports, and the Court ordered the production of this information beginning on the date Colopast began to develop the device, but did not compel the production of databases or spreadsheets on such reports . "Plaintiffs have all adverse event reports, and their request for production for the entire underlying database of adverse reports is not proportional to the needs of this case." Id. at *43.
Judge Nelson denied a request to compel the production of documents related to the design of the device. Noting that the Plaintiffs' claims with respect to the design of the device are a negligence and a strict liability claim, he concluded that, "Plaintiffs have not made a threshold showing of relevance to their claims in this case that would necessitate Defendants to search for and produce every single email related to the design of the Virtue from 2007 through 2015, and such request is not proportional to the needs of this case. Defendants represent they have produced comprehensive design documents concerning all versions of the Virtue, which is the information relevant for Plaintiffs to prove that the Virtue, as designed, failed to perform safely as expected by an ordinary consumer." Id. at *46.
The Court did order the production of Standard Operating Procedure documentation relating to the manfacture, post-marketing surveillance, and package inserts for the device. The Court rejected the Defendants' position that a master complaint list and associated notes were sufficient production for documentation on complaints and malfunctions of the device, and ordered the production of such documentation despite that fact that it would necessitate a substantial search and production.
Judge Nelson ordered the production of emails related to pre-clinical trials and testing of the device despite the production of other documents regarding such testing. He also ordered the production of internal communications regarding the safety of the device and informed consent forms.
The Court granted the motion to compel the production of third party agreements concerning the safety of the device; comparison of it with similar devices; and package inserts and product labels for the device because of the failure of the Defendants to contest the Plaintiffs' arguments for production of such documents.