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.

Middle District of Louisiana: Rule 37(a)(1), Opposing Counsel Must Refuse to Confer After Reasonable

This past Thursday, in Lewis v. E. Baton Rogue Parish, 16-352-JWD-RLB, 2018 U.S. Dist. LEXIS 134433 (M.D. La. Aug. 9, 2018), Magistrate Judge Richard L. Bourgeois, Jr. denied the Plaintiff's Third Motion to Compel Against Sheriff Gautreaux.

The parties in this case held multiple conferences on ESi search terms used by the parties without coming to an agreement on which terms should be used. The parties exchanged screen shots regarding the searches. The Defendants filed a brief objecting to the Plaintiff's search terms and proposing alternative search terms. Sheriff Gautreaux opposed the motion on the basis of the Plaintiff's failure to comply with Fed. R. Civ. P. 37(a).

After the defense counsel contended at oral argument that it would take 2-3 weeks to agree on search terms, and 3 months to collect, review and produce relevant ESI, the Court suspended all discovery deadlines. Fed. R. Civ. P. 37(a)(1) requires that a motion to compel include a certification that the party attempted to confer with the party failing to make a production. No such certification was submitted in this case, but the Plaintiff did submit an affidavit stating that he was unable to meet and confer with defense counsel. Since defense counsel continued to negotiate on the terms of the ESI protocol, the Court found that the Plaintiff violated Fed. R. Civ. P. 37(a)(1) and also failed to comply with a scheduling order that a meet and confer was conducted to resolve the dispute, and that opposing counsel refused to do so after a reasonable notice.

The Court concluded that, "Any future Rule 37 certificate filed in this action must specifically set forth the following: (1) how the conference was scheduled and agreed upon, (2) who participated in the conference, (3)when the conference took place, (4) whether the conference was conducted by phone or in person, (5)the duration of the conference, (6) the specific, itemized topics that were addressed at the conference, and (7) whether any issues were resolved by the parties. In the alternative, the Rule 37 certificate must detail the moving counsel's good faith attempts to confer with opposing counsel and provide evidence that opposing counsel refused to confer after reasonable notice." Id. at *8.

Northen District of Illinois: Random Sampling of Null Set Reasonable and Proportional

On Tuesday Judge Iain D. Johnston issued a ESI protocol order in City of Rockford v. Mallinckrodt ARD, Inc., No. 17 CV 50107; No. 18 CV 379, 2018 U.S. Dist. LEXIS 133332 (N.D. Ill. Aug. 7, 2018). This is a breach of contract case concerning Acthar, a drug used to treat multiple sclerosis. The case involves millions of documents, and the Defendants will produce most of them. The parties in this case agreed to use keyword searching, and conferred on specific search terms. Hit reports were exchanged, and the producing party permitted the requesting party to review a statistical sample to confirm the percentage of responsive documents that the keyword searches returned.

The Defendants want to resolve a dispute about whether or not responsive documents were included in the search results with a meet and confer, and the Plaintiffs proposed reviewing a random sample of the 'null set' (the documents not included in the search results) to determine how many documents in it are relevant - a process called elusion.

Judge Johnston acknowledged the growing consensus that TAR is superior to keyword searching, but also cited several sources that asserted that keyword searching could more effectively identify responsive documents. "Indeed, when being pitched on the virtues of TAR, some parties, attorneys and courts may feel —albeit without any evidence-based reason — as though they are being sold a monorail." Id. at *12.

The Court concluded that sampling a null set is reasonable means under Fed. R. Civ. P. 26(g) to verify that discovery is complete and correct. The review of the null set in this case confirmed that the review process was defensible. "The defendants provided that less than 5 percent of the documents reviewed each defendant's 'null set' sample(the documents not hit upon in their search efforts) were deemed potentially responsive upon additional QC. This would mean that 95 percent were not relevant and therefore appropriately cast aside. Certainly that should be considered a reasonable result under the rules." Id. at *15.

Judge Johnston also concluded that sampling a null set was proportional and not burdensome under Fed. R. Civ. P. 26(b)(1). He noted the extraordinary circumstances of this case:

1. Acthar was prescribed to infants at the cost of tens of thousands of dollars.

2. The case has attracted national media attention.

3. The amount in controversy consisted of a potential sum of damages which made this a 'bet the company' case.

4. The Defendants have access to the vast majority of relevant documents.

5. ESI plays a key role in the case.

6. The burden of random sampling of the null set is outweighed by the benefit of reasonable, but not perfect production.

The Court ruled that a confidence level of 95% and a margin of error of 2% was valid to calculate the size of the random sample set. This means one can be confident, at the 95% level, that out of every 100 simple random samples taken from a given population, 95 of them will contain the true percentage, within a margin of error of plus or minus 2 %.