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The U.S Judicial Panel on Multidistrict Litigation (JPML) has rejected a request to consolidate and centralize all federal proton pump inhibitor lawsuits before one judge for coordinate management, indicating that the claims filed over kidney problems associated with Nexium, Prilosec, Protonix and other related drugs involve too many different defendants and products to justify a single multidistrict litigation (MDL).
Proton pump inhibitors (PPI) are a popular class of heartburn and acid reflux medications, including some of the top selling drugs in the world.
Over the past year, a growing number of Nexium lawsuits, Prilosec lawsuits, Prevacid lawsuits, Protonix lawsuits,Dexilant lawsuits and other claims have been filed against the manufacturers of PPI medications, alleging that information was withheld from consumers and the medical community about the risk of chronic kidney disease, kidney failure and other serious health complications linked to the medications.
Given the related scientific issues raised in the cases, a group of plaintiffs filed a motion last year with the U.S. JPML, seeking to transfer cases pending in U.S. District Courts nationwide to one judge for coordinated discovery, to avoid contradictory pretrial rulings from different courts and to serve the convenience of witnesses that will testify in multiple cases.
Following oral arguments heard by a panel of federal judges on January 26, the JPML issued an order denying transfer (PDF) yesterday, indicating that there are currently too few cases pending nationwide, and too many different competing drug makers involved in the litigation to require coordinated pretrial proceedings among all of the cases.
“Although all the subject drugs are PPIs, they are not identical,” wrote the Judge Sarah S. Vance, Chair of the JPML. “Some are available by prescription only, whereas others are sold over-the-counter. Each has a unique development, testing, and marketing history, and each was approved by the FDA at different times.”
The panel also pointed out that it is typically hesitant to centralize litigation involving multiple, competing defendants selling similar products, as the need to protect trade secrets and confidential information complicates case management.
Given the widespread use of these medications, as proton pump inhibitor lawyers continue to review cases in the coming months and years, it is widely expected that several thousand lawsuits will be filed throughout the federal court system. However, there are currently only about four dozen cases pending, suggesting that the request may be refiled in the future or separate MDLs involving different manufacturers may be considered if the litigation continues to expand.
Proton Pump Inhibitor Kidney Risks
The lawsuits over proton pump inhibitors include plaintiffs who have suffered various degrees of kidney injuries, including acute interstitial nephritis (AIN), acute kidney injury, chronic kidney disease, end-stage renal failure and wrongful death.
The first warnings about any kidney issues with PPIs were added to the drug labels in December 2014, indicating that there may be a risk of acute interstitial nephritis (AIN) risk from Nexium, Prilosec and other proton pump inhibitors. This condition involves inflammation of the kidneys, but plaintiffs maintain that the warnings do not go far enough to raise awareness about the serious risks associated with these medications.
In April 2015, a study published in the medical journal CMAJ Open found that Nexium, Prilosec, and other PPIs cause a 3 times higher risk of acute interstitial nephritis, but were also associated with a 2.5 times higher risk of acute kidney injury, which involves an abrupt loss of kidney function.
Earlier this year, a study published in the medical journal JAMA Internal Medicine built on these findings, examining data on more than 10,000 participants over a period of more than 10 years, finding that the drugs were also associated with a higher incidence of chronic kidney disease.
In April 2016, 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.
The decision to deny the creation of the MDL means the cases will continue forward as individual lawsuits in federal and state courts across the country.