Wrongful Death Lawsuit Filed Over Prilosec Side Effects

A product liability lawsuit filed against AstraZeneca blames the side effects of Prilosec for the wrongful death of a New York woman, who suffered multi-organ failure, respiratory arrest and pneumonia after suffering kidney failure allegedly caused by the popular heartburn drug. 

The complaint (PDF) was filed by Patrick Rusaw in the U.S. District Court for the District of New Jersey on August 23, on behalf of the estate of his month, Mary Manley, who died in August 2015.

Manley was prescribed Prilosec on numerous occasions starting in 2006, and the lawsuit indicates that neither she nor her doctors could have known about the potential kidney risks due to omissions and misrepresentations made by the drug maker.

“Defendant concealed and continue to conceal their knowledge of Prilosec’s unreasonably dangerous risks from Plaintiff, the FDA, the public and the medical community including Plaintiff’s prescribing physicians,” 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 Prilosec.”

Prilosec is a member of a popular class of acid reflux and heartburn medications known as proton pump inhibitors (PPIs), which also includes the blockbuster drugs Nexium, Prevacid, Protonix, Dexilant and others. The medications are used by millions of individuals worldwide and generate billions in sales each year for the drug manufacturers.

While the drugs are aggressively marketed as safe, and widely assumed to carry few serious side effects, several studies released in recent years have suggested that users may face an increased risk of kidney problems from proton pump inhibitors, including acute kidney injury (AKI), acute interstitial nephritis (AIN), chronic kidney disease (CKD) and kidney failure.

In December 2014, the FDA required the drug makers to add information to the label for the first time about the risk of acute interstitial nephritis (AIN) from Prilosec, but many critics have suggested that the information was not prominent enough to raise awareness about the kidney risks associated with proton pump inhibitors.

In April 2015, a study published in the medical journal CMAJ Open found that 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.

Last 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 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 case joins dozens of other lawsuits over Prilosec side effects, as well as similar Nexium lawsuits, Protonix lawsuits, Prevacid lawsuits and other claims brought on behalf of individuals nationwide in recent months.

Given similar questions of fact and law raised in the litigation, the Prilosec wrongful death lawsuit filed by Rusaw will be consolidated with cases filed against other drug makers, which are centralized before U.S. District Judge Claire C. Cecchi in the District of New Jersey as part of a federal MDL, or multidistrict litigation.

As individuals continue to learn about the link between the heartburn drugs and kidney problems suffered in recent years, it is widely expected that thousands of additional cases may be filed in the coming months and years.