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The makers Nexium, Prilosec Prevacid and similar heartburn drugs face a steadily growing number of lawsuits brought by users who have suffered serious kidney damage, with more than 13,000 cases pending throughout the federal court system.
A complaint (PDF) filed last week against AstraZeneca, Merck and Takeda Pharmaceuticals raises allegations similar to those presented by individuals nationwide, indicating that a New Hampshire man experienced kidney damage after several years of using different forms of the popular heartburn drugs, known as proton pump inhibitors (PPI).
The plaintiff, Wayne Samuels, says he began taking the medications in the early 1990s, and at different times through 2016 he used Nexium, Prilosec, Prevacid and Dexilant, which are all part of the same class of medications. However, the lawsuit alleges the long-term use resulted in the development of chronic kidney disease (CKD) in 2010.
Proton pump inhibitors (PPIs) include some of the best selling brand name drugs on the market in the United States, such as Nexium, Prilosec, Prevacid and others, which work by reducing the amount of stomach acid produced, helping prevent symptoms of heartburn and acid reflux.
While the drugs are widely believed to be safe, and often used for years by consumers, a number of studies have raised concerns about the potential side effects of the heartburn drugs, including both a risk of bone fractures, as well as kidney problems, cancer and infection risks.
Like other plaintiffs, Samuels claims the drug manufacturers failed to provide adequate warning about the risks of kidney damage, and other adverse health risks, to patients or the medical community.
“Defendants concealed and continue to conceal their knowledge of PPIs’ unreasonably dangerous risks from Plaintiff, Plaintiff’s physicians, other consumers, and the medical community,” the lawsuit states. “Specifically, Defendants failed to adequately inform consumers and the prescribing medical community about the magnified risk of kidney injuries related to the use of PPIs.”
The proton pump inhibitor litigation first emerged several years ago, following the publication of studies suggesting users may face certain kidney risks which 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 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.
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.