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With more than 13,000 Nexium lawsuits, Prilosec lawsuits and other claims pending throughout the federal court system over side effects of proton pump inhibitor (PPI) drugs, the U.S. District Judge presiding over the litigation has identified nine cases that will go through case specific discovery and be eligible for early trial dates expected to begin late next year.
Each of the claims raise similar allegations against manufacturers of the popular class of heartburn medications, which include Nexium, Prilosec, Prevacid, Protonix, Dexilant and others, indicating users and the medical community were not adequately warned about the risk of acute kidney injury, chronic kidney disease, end-stage renal failure and other complications associated with the medications.
Given common questions of fact and law raised in the complaints, U.S. District Judge Claire C. Cecchi has been presiding over the coordination of all discovery and federal pretrial proceedings in the U.S. District Court for the District of New Jersey, where a series of “bellwether” trials are expected to begin in November 2021.
Earlier this year, each side was directed to select 16 cases from an Eligible Case List, for a total of 32 potential bellwether cases. Each side was then allowed to strike six cases, for a maximum bellwether discovery pool of 20 cases.
On December 4, Judge Cecchi issued a case management order (PDF) announcing the Court and parties reduced the pool of potential bellwether cases to nine, which are expected to have all core discovery complete by January 21, 2021.
To ensure the cases move forward swiftly, Judge Cecchi put a “soft cap” on depositions, limiting each side to four depositions each. Afterwards, the pool will be reduced again to only six cases by January 29, 2021, which will be set for trial.
“The parties shall meet and confer regarding additional Core Discovery if they believe such discovery is needed beyond this date, so long as the additional discovery does not delay the selection of the final six (6) Bellwether Trial Cases, and recognizing that additional discovery is permitted in the final six (6) Bellwether Trial Cases,” Judge Cecchi wrote. “The parties will raise any disputed issues with the Court as the need may arise.”
To cut the nine cases down to six actual bellwether trial cases, plaintiffs will get to select one from the cases originally chosen by themselves and one chosen defendants, for a total of two cases. Similarly, defendants will get to select one of their own cases, and one case chosen by plaintiffs. The last two cases will be selected boy Special Master Ellen Reisman, who will select one case chosen by plaintiffs and one originally picked by defendants, based on claims that are most representative of other cases pending in the litigation.
The first in a series of bellwether trials is currently expected to begin on November 15, 2021, with additional trials likely to follow in early 2022.
While the outcome of these early test cases will not be binding on thousands of other Nexium and Prilosec claims pending in the MDL, they will be closely watched by parties involved in the litigation, as it will gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the claims.
Nexium, Prilosec Kidney Problems
The proton pump inhibitor litigation first emerged several years ago, following the publication of studies suggesting users may face certain kidney risks 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 in recent years.
Following the series of bellwether trials, 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.