Lawsuits Alleges Prilosec OTC Resulted in Kidney Failure Diagnosis

Millions of Americans take Prilosec, Nexium and other proton pump inhibitor (PPI) drugs, assuming that the other-the-counter heartburn and acid reflux drugs carry few, if any, serious side effects. However, hundreds of lawsuits have been filed on behalf of individuals nationwide, alleging that side effects of Prilosec or other similar medications caused the development of serious kidney problems.

In a product liability complaint (PDF) filed in the U.S. District Court for the District of New Jersey last week, Jesse Ivey indicates that he developed kidney failure following users of using Prilosec OTC (over-the-counter), which is widely available in drug stores nationwide.

Ivy used Prilosec OTC from December 2011 through April 2012, indicating that Proctor & Gamble and AstraZeneca knew or should have known about the kidney risks associated with their drug, yet provided false and misleading information for consumers and doctors, which suggested the medication was safe.

Prilosec is one of the most widely recognized brand name medications in the U.S., and is part of the same class of heartburn medications as Nexium, Prevacid, Protonix and others, known as proton pump inhibitors (PPIs). The medications generate billions in sales each year for the drug manufacturers, and have been aggressively marketed in recent years as over-the-counter treatments. However, several studies released in recent years have highlighted that users may face increased risks of acute kidney injury (AKI), acute interstitial nephritis (AIN), chronic kidney disease (CKD) and kidney failure, which are not disclosed on the product labels.

“Defendants, at all relevant times, knew or should have known of the problems and defects with Prilosec products, and the falsity and misleading nature of Defendants’ statements, representations, and warranties with respect to Prilosec products,” the lawsuit states. “Defendants concealed and failed to notify Plaintiff and the public of such defects.”

The case filed by Ivey joins a growing number of similar Prilosec lawsuits, Nexium lawsuits, Prevacid lawsuits and other claims against makers of PPI drugs, which have all be centralized in the federal court system before U.S. District Judge Claire C. Cecchi in the District of New Jersey, for coordinating the discovery and pretrial proceedings.

Proton Pump Inhibitor Kidney Risks

In December 2014, the FDA required new warnings for the first time about a form of kidney damage associated with proton pump inhibitors, known as acute interstitial nephritis (AIN), which involves a sudden inflammation of the kidneys, which can lead to more severe problems.

More recent studies have highlighted the potential link between Nexium and kidney problems, suggesting that the popular drugs make also cause users to experience acute kidney injury, chronic kidney disease and end-stage kidney failure, often resulting in the need for dialysis treatment or a kidney transplant.

Last year, a study published in the medical journal JAMA Internal Medicine also found an increased risk of chronic kidney disease with the heartburn medications, indicating that users of Nexium, Prilosec and other PPI may be 50% more likely when compared to non-users.

These findings were supported 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 part of the MDL proceedings, it is expected that Judge Cecchi will eventually establish a “bellwether” program, where small groups of cases against each drug maker will be prepared for early trial dates. While the outcomes of such trials are not binding on other plaintiffs, they are designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.