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The side effects of Prilosec, a popular heartburn drug, allegedly caused the wrongful death of a Texas man, who developed end stage renal disease after using the medication for more than a decade, according to a recently filed lawsuit.
The complaint (PDF) was filed against AstraZeneca in the U.S. District Court for the District of New Jersey on July 3, by Marie Orcutt and the estate of her husband, Earl Orcutt, in New Jersey federal court.
According to the lawsuit, Earl Orcutt died of end stage renal disease after using Prilosec from 1994 to 2016, presenting claims for strict product liability, design defect, failure to warn, negligence and negligence per se, breach of warranty, negligent misrepresentation, fraud and fraudulent misrepresentation, fraudulent concealment, loss of consortium and wrongful death.
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 class of medications generate billions in sales each year, and are now widely available over-the-counter.
Although most individuals assume that the drugs are safe, and carry few serious side effects, a growing number of Prilosec lawsuits, Nexium lawsuits, Prevacid lawsuits and other claims have been filed against the makers of PPI drugs in recent years, alleging that they failed to adequately warn about the risk that users may develop an acute kidney injury (AKI), acute interstitial nephritis (AIN), chronic kidney disease (CKD) or kidney failure.
The case filed by Orcutt will be consolidated with more than 4,500 similar claims that are pending in the federal court system, where the litigation has been been centralized 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
The proton pump inhibitor litigation has rapidly emerged following a series of independent studies published in recent years, which highlight the potential kidney risks with Prilosec, Nexium and other heartburn drugs.
The FDA required new warnings for the first time about a form of kidney damage associated with proton pump inhibitors in December 2014, requiring the drug makers to add new information to the labels about a condition known as acute interstitial nephritis (AIN), which involves a sudden inflammation of the kidneys, which can lead to more severe problems.
In April 2016, researchers with the Department of Veterans Affairs published a study that found 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.
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.
As part of the federal proceedings before Judge Cecchi, it is expected that a “bellwether” program will be established, where small groups of representative 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.