Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd.

Background

The order concerned a discovery dispute about source documents, raw data, and medical records underlying Meril’s 30-person and 100-person Myval-1 clinical trials in India. Edwards served document requests in September 2020. Magistrate Judge Kandis A. Westmore overruled Meril’s objections, found the raw data relevant to Edwards’s claim that Meril falsely reported data about the Myval heart valve, and ordered Meril to produce the data.

After further disputes, Judge Westmore ruled on May 20, 2021, that Edwards was entitled to anonymized raw data. Edwards later filed a renewed motion for sanctions, arguing that Meril continued to withhold underlying patient medical records and other documents. Meril argued that it did not possess, control, or have custody of the patient medical records and had produced the raw data it collected.

On January 14, 2022, Judge Westmore granted in part and denied in part Edwards’s renewed sanctions motion. Based on Meril’s Clinical Trials Agreements with participating institutions and the Myval-1 Clinical Study Protocol, Judge Westmore determined that the underlying patient medical records were within Meril’s legal custody or control and ordered Meril to produce them, including records held by the institutions.

Meril’s Motion

Meril asked the district court for relief from Judge Westmore’s January 14 order. Meril argued that the conclusion that the records and documents were owned by Meril or in Meril’s legal possession was clearly erroneous.

Under Federal Rule of Civil Procedure 72(a), a district court may change a magistrate judge’s non-dispositive order only if it is clearly erroneous or contrary to law. The district court reviews the order for clear error rather than replacing the magistrate judge’s judgment with its own.

After reviewing the agreements and study protocol, the court concluded that Judge Westmore’s determination was not clearly erroneous or contrary to law. The court therefore denied Meril’s motion for relief.

Other Relief Addressed in the Order

The court stated that Meril had to provide the relief requested in Edwards’s first request by 5:00 p.m. on January 28, 2022. That production included anonymized echocardiograms, accompanying reports, and other medical records underlying the Myval-1 study.

The court said it would consider Edwards’s requests to supplement its experts’ opinions and obtain additional deposition testimony after the records were produced. Judge Westmore was to address Edwards’s request for attorneys’ fees and costs in the first instance.

The court denied Edwards’s requests for a show-cause order concerning contempt and coercive sanctions of $10,000 per day. It also denied Edwards’s request for an evidentiary hearing about possible destruction of approximately 500 echocardiograms, finding that request unreasonable and unwarranted.