First Nexium, Prilosec Bellwether Trial Proposals Submitted Ahead of Status Conference

Lawyers involved in the federal litigation over kidney injuries linked to Nexium, Prilosec and other popular heartburn drugs have reached an agreement on a proposed scheduling order, which may result in the first bellwether trial beginning in May 2020.

There are currently about 4,500 Nexium lawsuits, Prilosec lawsuits, Protonix lawsuits, Prevacid lawsuits and other claims pending in the federal court system against the manufacturers of popular proton pump inhibitor (PPI) drugs, each raising similar allegations that users and the medical community were not adequately warned about the potential kidney risks.

Although it is widely assumed that the medications are safe and carry few serious side effects, independent studies published in recent years have suggested that users may be more likely to develop an acute kidney injury, chronic kidney disease, renal failure and other serious side effects.

Given common questions of fact and law raised in cases, the federal litigation has been centralized before U.S. District Judge Claire C. Cecchi in the District of New Jersey, for coordinated discovery and pretrial proceedings. The parties are scheduled to meet today for a status conference, at which time it is expected that the Court will address how to best manage and proceed with the federal multidistrict litigation (MDL).

On June 8, plaintiffs and defendants both submitted letters to the Court on both a proposed scheduling order and trial date, as well as issues of file production and depositions.

Initially, the parties disagreed about when the first bellwether trial should take place, with plaintiffs calling for a February 2020 trial date, and defendants calling for the first case not to go to trial until June 2020. However, according to the plaintiffs letter (PDF), the parties have reached an agreement, setting May 2020 as the proposed date the first case will go before a jury.

According to a proposed agenda (PDF) for the status conference today, the parties will also review with Judge Checchi a tolling agreement, updates on plaintiff fact sheets and defense fact sheets, schedules for depositions, discovery limits and other issues.

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.

As lawyers continue to review and file cases over the coming months, it is widely expected that more than 10,000 cases may be filed nationwide. In addition, amid recent studies suggesting a link between stomach cancer and Nexium, Prilosec and other PPI drugs, it is possible that the scope of the litigation may expand to cover additional injuries associated with the medication.