Sides Disagree About Trial Plan for Byetta, Januvia, Victoza Lawsuits

Competing case management proposals have been submitted by the leadership lawyers involved in the federal multidistrict litigation (MDL) established for all Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits filed by individuals diagnosed with pancreatic cancer after using the incretin mimetic diabetes drugs.

In August 2013, the U.S. Judicial Panel on Multidistrict Litigation established consolidated proceedings in the federal court system for cases filed by individuals who allege the makers of the Byetta, Januvia, Janumet and Victoza failed to adequately warn consumers and the medical community about the risk of pancreatic cancer.

There are currently at least 262 cases centralized before U.S. District Judge Anthony J. Battaglia in the Southern District of California, to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As part of the coordinated proceedings, Judge Battaglia ordered the parties to submit a joint proposal regarding various deadlines for discovery in the litigation and the selection of a small group of cases to serve as “bellwether” trials, which are generally designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout a large number of cases.

After lawyers appointed to leadership roles for the plaintiffs and defendants failed to reach an agreement on a joint proposal, competing memorandum were submitted earlier this week, which will be reviewed with the Court during a status conference scheduled for February 18.

Incretin Mimetic Pancreatic Cancer Bellwether Proposals

According to the memorandum (PDF) submitted by the defendants on February 10, the makers of the diabetes drugs are pushing for an unorthodox trial plan, which asks for submission of Plaintiffs’ general causation expert reports in less than 90 days, prior to completion of discovery into common issues surrounding the design and research of the medications.

Lawyers for Merck, Amylin Pharmaceuticals, Eli Lilly and Novo Nordisk are requesting that the Court schedule “general causation” expert discovery and challenges to the admissibility of that testimony early in the litigation, rather than waiting until the eve of the first trials, as is common in complex pharmaceutical litigation.

The drug makers claim that the scientific consensus in the medical community is that Byetta, Victoza, Janumet and Januvia do not cause pancreatic cancer, indicating that this litigation is different because none of the products have been recalled and there no studies have definitively concluded that the medications increase the risk of pancreatic cancer. Therefore, the defendants ask the Court to take up general causation prior to a lengthy litigation process.

“No matter the outcome, early resolution of the general causation question will advance the ultimate objection of the MDL process – the resolution of issues common to all cases,” wrote Defendants in their proposal. “If plaintiffs cannot produce reliable expert testimony to support their general causation claims, defendants will have the grounds for summary judgement (to dismiss cases). If, on the other hand, the Court finds that plaintiffs’ experts’ opinions on general causation are based on reliable science, the issue will have been resolved, the parties will have gained valuable information about the cases, and both the Court and the parties can move on to other issues.”

Plaintiffs’ lawyers appointed to leadership roles in the incretin mimetic litigation have filed a brief (PDF) urging the Court to reject the drug makers’ proposals, indicating that the defendants are attempting to bring the issue of general causation before former users will have an opportunity to fully investigate the case and select the appropriate experts.

Plaintiffs point out in their memorandum that drug makers have substantially more information about a medications safety than all other publicly available sources combined, including government records. Therefore, discovery of internal documents and data may greatly impact the question of general causation.

“As the Plaintiffs explained at Science Day (on February 5 and 6), all Plaintiffs request is that causation be evaluated on the ‘sum of all the evidence,’” wrote attorneys in the response filed by users. “Defendants, in turn, request that causation be evaluated on ‘all’ the evidence… except the evidence in their possession.”

The proposal put forth by the plaintiffs follows the more conventional case management plan in complex litigation where a large number of claims have been filed by users of similar medications who claim to have suffered similar injuries. This would involve general discovery, followed by expert discovery, motions and a schedule for early bellwether trials.

Plaintiffs are asking the court to enter separate case management orders that call for a series of early trial dates involving each of the medications, starting with two Byetta trials starting in late November 2015 and February 2016. This would be followed by trial beginning in October 2016 involving Januvia, with trials involving either Januvia or Janumet set for January 2017 and July 2017. Victoza trials would begin in April 2017 and October 2017.

To prepare for first Byetta cases for trial, Plaintiffs are asking the Court to establish a deadline for later this year, where each side will select three cases to go through case-specific discovery between September 2014 and March 2015. Following completion of this fact discovery, two Byetta cases would be selected to serve as the early bellwether trials by April 2015, and expert disclosures would be required in those cases by May 1, 2015. Expert discovery would be concluded by July 1, 2015, with all dispositive motions addressing challenges to the reliability of expert testimony filed by July 31, 2015.

Judge Battaglia is expected to discuss these competing case management proposals during a status conference currently scheduled for February 18, 2014.

In addition to pancreatic cancer cases, there are currently at least 35 Byetta thyroid cancer lawsuits being pursued in the federal court system, which are not currently part of the MDL. However, a motion was filed last month with the U.S. Judicial Panel on Multidistrict Litigation (JPML), asking that these cases also be centralized before Judge Battaglia to reduce duplicative discovery into common issues, to avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.