Prevacid and Nexium Lawsuit Filed Over Acute Kidney Injury

According to allegations raised in a product liability lawsuit filed this week against AstraZeneca and Takeda Pharmaceuticals, side effects of Nexium and Prevacid caused a long-term user of the popular heartburn medications to suffer an acute kidney injury. 

The complaint (PDF) was filed by Terry Buzbee in the U.S. District Court for the Eastern District of New York on June 13, alleging that the drug makers failed to adequately warn users and the medical community about the risk that users may suffer serious kidney damage after using medications that are part of a class of drugs known as proton pump inhibitors (PPI).

Nexium (esomeprazole) and Prevacid (lansoprazole) are among the best selling members of this popular class of drugs used for treatment of heartburn and acid reflux, generating billions a year in sales. Other proton pump inhibitors (PPIs) include Prilosec, Protonix, Dexilant, AcipHex, Zegerid and generic equivalents.

Although the medications are widely believed to be safe, a number of studies published in recent years suggest that users face kidney risks from Nexium and other PPIs, including increased incidence acute interstitial nephritis, acute kidney injury, chronic kidney disease and end-stage renal failure.

According to the lawsuit, Buzbee began taking Nexium and Prevacid in October 2006 for the treatment of peptic disorders including gastroesophageal reflux disease (GERD), peptic ulcer disease, and nonsteroidal anti-inflammatory drug induced gastropathy. He continued to use the drugs until April 2016.

As a result of the medications, Buzbee indicates that he suffered acute kidney injury requiring hospitalization, and has been left with severe and permanent injuries that will require life-long medical care and monitoring.

The complaint comes as a growing number of individuals throughout the United States are preparing to file similar Nexium lawsuits, Prevacid lawsuits, Prilosec lawsuits and other claims involving kidney injuries suffered following use of the popular heartburn drugs.

The litigation has arisen following a warning label change required by the FDA in December 2014, which added information for the first time to Nexium and other PPIs about the risk of acute interstitial nephritis seen among users of the heartburn drugs. This condition involves inflammation that can lead to kidney injury or kidney failure if not promptly treated.

In April 2015, a study published in the medical journal CMAJ Open found that in addition to acute interstitial nephritis, Nexium and other similar drugs may also increase risk of acute kidney injury, which involves an abrupt loss of kidney function.

That research was followed by a study published earlier this year in the medical journal JAMA Internal Medicine, which found an increased risk of chronic kidney disease with use of proton pump inhibitors. That study suggested that users of Nexium, Prilosec and other heartburn drugs may face a 50% higher kidney disease risk when compared to non-users.

Last month, yet another study published in the Journal of the American Society of Nephrology, found an increased risk of kidney failure and chronic kidney disease associated with long-term use of Nexium and other PPIs.

Buzbee’s complaint indicates that the manufacturers of Nexium and Prevacid knew or should have known about the kidney problems since at least 2004, when adverse event reports began to pour into the FDA.

“Specifically, Defendants had received numerous case reports of kidney injuries in patients that had ingested Nexium by as early as 2004,” the lawsuit states. “These reports of numerous kidney injuries put Defendants on notice as to the excessive risks of kidney injuries related to the use of Nexium. However, Defendants took no action to inform Plaintiff or Plaintiff’s physicians of this known risk. Instead, Defendants continued to represent that Nexium did not pose any risks of kidney injuries.”

The lawsuit accuses both manufacturers of concealing and failing to provide crucial safety information about the popular drugs in order to maximize profits.

Prescription PPIs were used by more than 15 million Americans in 2013, bringing in more than $10 billion. Some estimates indicate that between 25% to 70% of those prescriptions may be inappropriate. Nexium is the third best selling drug in the world, with sales in 2008 exceeding $5.2 billion at its peak.

Buzbee’s lawsuit presents claims of negligence, strict product liability, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, seeking both compensatory and punitive damages.