Nearly 14,000 Lawsuits Over Nexium, Prilosec and Other PPI Heartburn Drugs Pending in Federal MDL

The makers of Nexium, Prilosec, and Prevacid face nearly 14,000 product liability lawsuits filed throughout the federal court system, involving allegations that side effects of the widely used heartburn drugs may cause kidney damage and other health problems.

According to a report submitted to the U.S. District Judge presiding over all federal Nexium lawsuits, Prilosec lawsuits and other complaints involving kidney problems linked to proton pump inhibitor (PPI) heartburn drugs there are at least 13,919 lawsuits filed, involving 13,950 different plaintiffs.

Each of the claims raise similar allegations that users and the medical community were not adequately warned the widely used heartburn medications may increase the risk of chronic kidney disease, acute kidney injury, kidney failure and other side effects.

Given common questions of fact and law raided in complaints filed throughout the federal court system, coordinated pretrial proceedings have been established before U.S. District Judge Claire C. Cecchi in the U.S. District Court for the District of New Jersey, as part of a multidistrict litigation (MDL). The claims are centralized to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings and serve the convenience of common witnesses, parties and the judicial system.

In addition to claims pending in the federal MDL, there are also more than 200 similar lawsuits filed in various state courts, including Delaware, Illinois, New Jersey and Ohio.

On April 17, parties involved in the litigation filed a joint status report (PDF) on the PPI litigation, updating the court about the number of cases involved in the growing litigation. The report also proposed various agenda items for a status conference scheduled for the April 22, at which time the parties are expected to update Judge Cecchi on the status of bellwether trial pool selections, update the discovery proceedings, and take other actions to move the litigation forward.

The conference is being held by telephone, due to the ongoing coronavirus pandemic.

Late last year, the parties were ordered to select 20 representative cases for a discovery pool, which will be reduced down to a group of six claims that will be eligible for early trial dates in the MDL. The first trial was slated to begin in November 2021, but it is unclear whether the pandemic will delay that trial.

Nexium, Prilosec Kidney Problems

The proton pump inhibitor litigation first emerged several years ago, following the publication of studies that suggested users may face certain kidney risks that were not disclosed on the warning labels for popular heartburn drugs, including Nexium, Prilosec, Protonix, Prevacid and other medications.

The FDA required new warnings about potential kidney risks for the first time in December 2014, indicating that 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.

While the outcome of the early bellwether trials before Judge Cecchi will not be binding on other Nexium and Prilosec cases pending in the litigation, they will be closely watched and may have a big influence on any eventual settlement negotiations, which would be necessary to avoid thousands of individual cases being set for separate trial dates nationwide in the coming years.