Boîte à outils pour les litiges complexes dans le domaine de la santé : utilisation des fiches d'information du plaignant et des procès sommaires devant jury

On May 15 and 30, 2023, the Northern District of California conducted two “summary jury trials” in a pharmaceutical lawsuit brought by patients who claimed that taking the U.S. Food and Drug Administration (FDA)-approved HIV/AIDS medication developed and manufactured by defendant Gilead Sciences Inc. resulted in kidney and bone damages.

The two cases were brought by individuals who had taken medications developed by Gilead that contain the compound tenofovir disoproxil fumarate (TDF). These plaintiffs claim that Gilead’s drugs containing TDF are defective, that Gilead failed to warn patients concerning the risks of bone and kidney damage, and that Gilead’s decision to develop drugs containing TDF rather than the safer compound tenofovir alafenamide fumarate (TAF) resulted in unnecessary damages to patients. The cases were consolidated before Judge Jon S. Tigar in the Northern District of California. During the course of the litigation, thousands of plaintiffs across the nation have asserted similar claims against Gilead.

A “summary jury trial” is a unique form of alternative dispute resolution that allows the parties to present evidence to actual jurors in a non-binding proceeding before any binding trial proceeding takes place. As discussed in further detail below, the court’s use of this process, along with detailed Plaintiff Fact Sheets that all plaintiffs were required to complete, provides important lessons to defendants in complex, multi-plaintiff litigation.

Plaintiff Fact Sheets

Plaintiff Fact Sheets (PFSs) provide defendants with a crucial discovery tool when faced with consolidated cases brought by hundreds of individual plaintiffs. Here, the parties reached an early agreement on 24-page PFSs that each individual plaintiff would have to complete.

The Court ordered each individual plaintiff to complete the PFS in a set period of time, generally within sixty days of their case’s consolidation into the case before Judge Tigar. Additionally, they were required to produce responsive documents to certain requests contained in the PFS.

Following a review of the PFSs that were submitted, Gilead filed a motion to dismiss Plaintiffs’ claims for failure to prosecute and failure to comply with the Court’s Case Management Order. Gilead argued that it experienced prejudice as a result of the failure by plaintiffs to provide PFSs and to cure deficiencies in the ones that were submitted, and that dismissal was an appropriate sanction. Plaintiffs responded that they were in the process of supplementing initial PFSs and that Gilead had experienced no prejudice.

Eventually, the parties reached an agreement, entered by the court, in which 548 individual plaintiffs cured the deficiencies in their PFSs, 22 plaintiffs voluntarily dismissed their claims, counsel for 52 plaintiffs withdrew their appearances, and representatives for 27 deceased plaintiffs agreed to supplement their PFSs within 90 days.

For practitioners, this result is highly instructive. First, it demonstrates the critical importance of designing a thorough, fact-intensive PFS that also provides a mechanism for the production of documents by individual plaintiffs. Properly preparing for and completing fact discovery, including depositions of class representatives, requires as much information as possible.

Second, it underscores the importance of a detailed review of completed PFSs for missing information or other deficiencies. This is important for the service of deficiency notices to plaintiffs in order to either receive the missing information from the PFSs or to move for dismissal. As Gilead flagged to the court, federal appellate courts have affirmed the dismissal of claims where plaintiffs failed to timely submit PFSs. See, e.g., In re Phenylpropanolamine (PPA) Prods. Liab. Litig., 460 F.3d 1217, 1232-43 (9th Cir. 2006); In re Taxotere (docetaxel) Prods. Liab. Litig., 966 F.3d 351 (5th Cir. 2020)

As Gilead demonstrated to the court, its review provided a complete record of the deficiencies of the PFSs, including failures to provide information concerning the nature of injuries, failure to identify health care providers, failure to provide information concerning the use or discontinuance of use of the products at issue, failure to provide information concerning medical diagnostics, and failure to provide expenses. And putting in this work paid off for Gilead not just in additional information, but even in securing dismissal of a number of claims.

Summary Jury Trials

Early in the case, in January 2020, Judge Tigar issued a Case Management Order adopting a proposal from Plaintiffs to conduct a “summary jury trial” pursuant to Fed. R. Civ. P. 16 and N.D. Cal. ADR Local Rule 8-1(b). Despite Gilead’s objections that the court could not compel a summary jury trial, the court determined that it was within its discretion to order this process which it thought would “enable the Court and the parties to identify in advance any aspects of a full trial on the merits that might present manageability concerns.”

A summary jury trial permits the parties to present their cases over the course of one-day “trials” before jurors selected from their own voir dire process, with loosened evidentiary rules and, in theory, provides the court and the parties with an opportunity to facilitate settlement discussions. As Judge Tigar explained in his initial order, the “use of summary jury trials will: (1) give the parties good information about the value of these cases; (2) save the parties and the Court time and money by encouraging earlier settlement; and (3) inform the parties and the Court about the best way of conducting binding jury trials when the case reaches that stage.”

As Gilead argued, however, any perceived value to the parties and the court was significantly outweighed by the significant expenses that Gilead would incur in preparing for and conducting multiple summary jury trials, particularly while there remained outstanding issues that could be resolved on summary judgment. Further, Gilead observed that in a case such as a products liability litigation involving live witnesses, the utility of a one-day summary jury trial would be limited. Gilead also argued that summary jury trials are an incredibly rare occurrence, and there are less cost-intensive methods of alternative dispute resolution (ADR) available to the parties that may assist with evaluating the strength of the parties’ respective cases.

Although public information concerning the summary jury trials was restricted by the court, the essential structure of the two trials required the parties to:

• Each submit a five-page trial brief, summary jury instructions, and an agreed statement of the case to read to the jury 14 days before the summary jury trial.
• Each identify an individual plaintiff from a selected discovery pool.
• Not present live witnesses, but rather submit all evidence through attorneys for the parties, including physical exhibits such as documents produced in discovery and portions of deposition transcripts.
• Limit themselves to one hour and fifteen minutes to present their affirmative cases.
• Present fifteen-minute closing arguments.

Of particular interest is the jury process in this summary jury trial. Each trial was held before two six-member juries. The first jury, the “Group Jury,” was assigned to return a consensus verdict. The second jury, the “Individual Jury” was assigned to return a verdict on liability/damages. Another unique aspect was the jurors had the option after the summary jury trial to discuss the case with the attorneys if they desired.

Although it remains to be seen if these summary jury trials will have any impact on the litigation, the Gilead litigation demonstrates to counsel for defendants in multi-plaintiff litigations that plaintiffs may use summary jury trials as a potential tactic, and that courts may be amenable to them despite defendants’ objections. Practitioners should be prepared both to argue against their use early in the case, and to effectively present their case in the different format summary trials require, if needed.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.