Pretrial Schedule Outlined for First Nexium Bellwether Claim in Federal MDL

The first Nexium bellwether lawsuit is scheduled to go before a jury in October

The U.S. District Judge presiding over more than 13,000 federal Nexium lawsuits, Prilosec lawsuits, Prevacid lawsuits, and other claims involving kidney problems caused by proton pump inhibitors, has outlined the pretrial schedule for preparing the first bellwether claim for trial, which is expected to begin in October 2022.

Proton pump inhibitors are among the most widely recognized brand-name drugs on the market in the United States, including blockbuster treatments like Nexium, Prilosec, Prevacid, Protonix, Dexilant and others, which have been used by millions of Americans for treatment of acid reflux and heart burn.

While drugs have been promoted for years as safe and effective, leading many to believe they carry few serious side effects, the lawsuits allege the manufacturers failed to adequately warn about the risk of kidney complications, including acute kidney injury, chronic kidney disease, end-stage renal failure and other side effects.

Given common questions of fact and law raised in thousands of complaints brought throughout the federal court system, the litigation has been centralized before  U.S. District Judge Claire C. Cecchi in New Jersey since late 2019, as part of an MDL or multi-district litigation.

On February 17, Judge Cecchi issued a case management order (PDF), setting various deadlines for a Nexium bellwether trial, which will be the first of at least three claims expected to begin late this year through early 2023, to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

A Nexium kidney disease lawsuit brought by James Rieder was previously selected for the first trial date, which was set for early October or 30 days after the Court rules on final motions for summary judgment and requests to exclude certain expert witness testimony.

According to the recent scheduling order, a Special Master will hear oral arguments on preemption motions filed in all of the bellwether trial pool cases will be held on March 28, with oral arguments on Daubert motions set for April 4. The parties will then exchange exhibit and witness lists, and if Judge Cecchi determines that an additional hearing on summary judgment or expert motions is needed, it will be held on July 29, 2022. The Court will hold a final pretrial conference for Rieder on or before October 3, with jury selection scheduled to bein on October 6, 2022.

Nexium, Prilosec Kidney Risks

The proton pump inhibitor litigation first emerged several years ago, following the publication of studies suggesting users may face certain kidney problems from Nexium, Prilosec, Protonix, Prevacid and other similar heartburn medications, which was not disclosed to consumers and the medical community.

The FDA required new warnings about potential PPI kidney risks for the first time in December 2014, indicating use of the drugs may increase the risk of a form of kidney damage known as acute interstitial nephritis (AIN), which involves a sudden inflammation of the kidneys, which can lead to more severe problems. However, plaintiffs maintain this warning remains inadequate and vague, failing to mention the drugs may cause an acute kidney injury, chronic kidney disease or kidney failure.

In January 2016, an independent study published in the medical journal JAMA Internal Medicine found an increased risk of chronic kidney disease with the heartburn medications, indicating users of Nexium, Prilosec and other PPI may be 50% more likely when compared to non-users.

These findings were followed 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.

As consumers have learned about a link between their heartburn drug and kidney problems suffered in recent years, a rapidly growing number of lawsuits have been filed throughout the federal court system in recent years.

Following the series of bellwether trials set to begin later this year, if the parties fail to reach settlements or otherwise resolve large numbers of cases, Judge Cecchi is likely to start remanding cases back to U.S. District Courts nationwide for individual trial dates.