MDL Judge Refuses To Split Nexium, Prilosec Kidney Injury Litigation Into Two Phases

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, the federal judge presiding over the litigation has indicated that case-specific fact discovery in individual cases will proceed, after rejecting a proposal by the drug makers to first address challenges based on preemption and general causation.

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, the size and scope of the litigation is expected to double, or even triple in size over the coming months and years.

Each of the complaints involve 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. 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).

Last month, plaintiffs and defendants filed competing proposals on how to move forward with the litigation, with defendants calling for the court to bifurcate the proceedings. This would have set aside individual cases, while the court addressed motions to dismiss on the basis of federal preemption and whether the heartburn drugs generally pose an increased risk of kidney injury.

Plaintiffs objected to splitting the litigation into two phases, which had already been rejected by the court once before, calling for Judge Cecchi to quickly move to adopt a bellwether program, where a small group of representative cases would be selected for trial dates starting in early 2020. While the outcomes of these bellwether trials 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 likely to be repeated throughout the litigation.

In a case management order (PDF) issued on May 18, Judge Cecchi denied the defendants’ motion to bifurcation approach, and ordered the parties to meet and confer on the plan proposed by plaintiffs. The order does not explain Judge Cecchi’s decision, simply stating that it came out of discussions of various issues with the parties in a May 1 case management conference.

The next status conference is scheduled for June 12, and Judge Cecchi has called for parties to submit a joint status report and agenda ahead of that conference, by June 8.

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.

In January 2016, 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.