Plaintiffs Push for Nexium, Prilosec “Bellwether” Trial Dates Over Kidney Injuries

As a growing number of Nexium lawsuits, Prilosec lawsuits, Protonix lawsuits, Prevacid lawsuits and other claims continue to be filed over kidney injuries allegedly caused by proton pump inhibitor (PPI) heartburn drugs, plaintiffs are asking the federal judge presiding over the litigation to adopt a “bellwether” schedule, which would set cases for trial starting within the next two years.

There are currently about 4,200 claims filed against manufacturers of the popular heartburn and acid reflux medications, each adopting similar allegations that users were not adequately warned about the potential kidney side effects of PPI drugs. However, as lawyers continue to review and file claims over the coming months and years, the size and scope of the litigation is expected to double, or even triple in size.

Each of the complaints raise claims that users developed chronic kidney disease, acute kidney injury, end-stage renal failure or other problems following use of Nexium, Prilosec, Protonix, Prevacid or another PPI, which have been used by millions of Americans amid aggressive marketing by the drug makers. Although many doctors and patients assume the medications are safe, lawsuits allege that the drug makers withheld important information about the kidney risks.

Given common questions of fact and law raised in cases brought throughout the federal court system, the litigation is centralized before U.S. District Judge Claire C. Cecchi in the District of New Jersey, who is presiding over coordinated discovery and pretrial proceedings. The parties are scheduled to meet with the court tomorrow for a status conference, which will address how to best manage and proceed with the federal multidistrict litigation (MDL).

In a proposal (PDF) submitted on April 27, Plaintiffs’ Co-Lead Counsel urged Judge Cecchi to adopt a “bellwether” program, where a small group of representative cases will be selected for early trial dates starting in February 2020. While the outcomes of these early trial dates would not be binding on other claims, they would be designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

The drug makers have filed a competing proposal (PDF), which asks the court to bifurcate the proceedings, setting aside individual cases while the court addresses motions to dismiss on the basis of general causation and federal preemption. The defendants alternatively propose allowing broader case-specific discovery to move forward, but delaying any trial or individual case work up.

Plaintiffs have objected to this bifurcated approach, which the Court previously rejected, indicating that the drug makers “blindsided Plaintiffs” by withdrawing a prior scheduling proposal and now asking that the Court resolve issues of general causation and preemption prior to preparing any individual cases for trial.

“[T]here is nothing to be gained by delaying a trial in this litigation, as the parties need trials to evaluate the strengths and weaknesses in their claims and defenses to bring resolution to the thousands of cases that have and will be filed,” according to the proposal submitted by the plaintiffs’ leadership counsel. “Moreover, under the Defendants’ proposal, it would be years before a single case is tried. Our clients, many of whom are elderly, should not have to wait years to have their cases heard. Nor should Defendants be permitted to engage in further gamesmanship and delay with respect to moving this litigation forward.”

According to a joint status report (PDF) submitted in advance of tomorrow’s conference, the parties intend to discuss these competing proposals, as well as other issues in the litigation, including an approaching “Science Day”, at which time the parties will make non-adversarial scientific presentations designed to educate the court.

Proton Pump Inhibitor Kidney Lawsuits

The proton pump inhibitor litigation has rapidly emerged following the publication of several studies, which suggest that users may face certain kidney risks that are not disclosed on the warning labels for the popular heartburn drugs.

In December 2014, the FDA required new warnings for the first time about a form of kidney damage associated with proton pump inhibitors, known as acute interstitial nephritis (AIN), which involves a sudden inflammation of the kidneys, which can lead to more severe problems.

More recent studies have highlighted the potential link between Nexium and kidney problems, suggesting that the popular drugs make also cause users to experience acute kidney injury, chronic kidney disease and end-stage kidney failure, often resulting in the need for dialysis treatment or a kidney transplant.

Last year, a study published in the medical journal JAMA Internal Medicine also found an increased risk of chronic kidney disease with the heartburn medications, indicating that users of Nexium, Prilosec and other PPI may be 50% more likely when compared to non-users.

These findings were supported by another study published in April 2016, in which researchers with the Department of Veterans Affairs found that users of Nexium, Prilosec or other PPIs may be 96% more likely to develop kidney failure and 28% more likely to develop chronic kidney disease after five years of use.

Following any pretrial proceedings in the MDL, as well as potential “bellwether” trials, if the parties fail to reach settlements or another resolution for the litigation, each individual lawsuit may eventually be remanded back to the U.S. District Court where it was originally filed for a separate trial date.