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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 is pushing the litigation forward, despite limitations caused by the ongoing COVID-19 global pandemic, with a series of status conferences to be held via telephone and witness depositions continuing remotely.
Makers of the popular heartburn drugs face nearly 14,000 product liability lawsuits brought by individuals throughout the federal court system, each raising similar allegations that users and the medical community were not adequately warned that side effects of proton pump inhibitors may increase the risk of chronic kidney disease, acute kidney injury, kidney failure and other side effects.
Given common questions of fact and law raised in the complaints, 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 federal 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.
Prior to the COVID-19 pandemic, the parties were preparing a small group of representative claims for early trial dates, which were expected to begin in November 2021.
While the outcomes of these cases would not binding on other claims, the “bellwether” trials are intended to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout thousands of claims in the litigation, and facilitate eventual Nexium and Prilosec settlement negotiations that may avoid the need for each case to go to trial.
In a case management order (PDF) issued on May 11, Judge Cecchi called for parties to meet and confer on a wide variety of issues in the coming weeks via remote communications methods. The Court indicated it will not require witnesses directly impacted by COVID-19 to sit for their depositions, but others can proceed on a remote basis.
In a letter to the court (PDF), plaintiffs’ attorneys indicated both sides are narrowing their differences on how the remote depositions should be conducted. However, they have come to a crossroads over witness exhibits, with Defendants asking for paper copies despite the ease at which electronic copies could be distributed.
“Defendants seek to take advantage of present conditions by demanding that witnesses and their counsel be provided with hard-copy copies of all exhibits greater than 25 pages, in advance of the deposition,” they wrote. “This is not only unnecessary but inconsistent with the Federal Rules, the parties’ prior practice during depositions, and the very concept of conducting depositions remotely.”
The letter indicates the defendants’ request creates safety risks for attorneys, staff, witnesses, and even those who have to deliver the documents physically, due to the ongoing pandemic.
A letter from defense attorneys (PDF) representing the drug manufacturers claims it is too cumbersome for them to review electronic copies of lengthy and complex documents.
Judge Cecchi has scheduled a telephone case management conference for May 20, where the issue will be discussed. It remains unclear whether delays and disruptions caused by the coronavirus pandemic may require postponement of the November 2021 trial dates.
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.
Following coordinated discovery and a series of bellwether trials, if the parties fail to settle or resolve large numbers of cases, Judge Cecchi may ultimately remand thousands of individual claims back to U.S. District Courts nationwide for individual trial dates in the coming years.