Proton Pump Inhibitors (PPI's) - Legal Marketing Concepts

Proton Pump Inhibitors (PPI) such as Prilosec, Provacid, and Nexium, are some of the most popular medications in the United States, generating more than $14 billion in sales annually. These medications have been marketed aggressively as safe and effective and are taken by some 15 million Americans to remedy heartburn related issues on a daily basis. However, a number of studies have suggested that users may face a potential risk of heart attack, kidney injury, chronic kidney disease (CKD) or kidney failure, gastric cancer, and bone mineral fatigue resulting in fractures.

According to a study published in the Journal of Neurogastroenterology and Motility in 2015, 44% of Americans experience some form of heartburn at least once a month. These drugs are used to reduce the amount of stomach acid, treating heartburn, acid reflux, ulcers in the stomach and small intestines, and gastroesophageal reflux disease (GERD).

FDA Warnings

In December 2014, the FDA required new warnings for Nexium, Prilosec, and other proton pump inhibitors, indicating that consumers were developing a condition called acute interstitial nephritis, an inflammation of the kidneys that may lead to chronic injury. New information indicates that manufacturers knew about the potential kidney risks with acid reflux drugs and failed to warn the public about these risks.

In April 2015, a study published in the CMAJ Open medical journal found that users of PPI’s are 250% more likely to have acute intestinal nephritis, which can lead to an abrupt loss of kidney function. The study involved a review of data on 300,000 people over 66 years of age who started acid reflux treatment with a PPI between April 2002 and November 2011. This particular age population was found to be at a significantly higher risk to develop an acute kidney injury when compared to users who were not taking the drug. Similarly, the risk of acute interstitial nephritis from acid reflux drugs was tripled for those users.

A study published in the medical journal JAMA Internal Medicine, in January 2016, examined whether PPI’s also present an increase in the risk of chronic kidney disease (CKD), a long-term condition that often leads to kidney failure and the need for dialysis treatment or a kidney transplant. Researchers reviewed data on 10,482 participants in the Atherosclerosis Risk in Communities study from February 1996 to December 2011, looking at self-reported heartburn drug use and outpatient prescriptions. They found that there was a 45% increased risk of developing CKD per the use of PPI drugs.

Another study, conducted by researchers from the VA St. Louis Health Care System, which was published in BJM Open in July 2017 revealed that prolonged use of PPI’s carried a 25% increased risk of death when compared to other types of heartburn drugs. A second study, also published in 2017 in Kidney International, indicated further associations between PPI’s and an increased risk of kidney disease and failure.

Current Status Of Litigation

In August 2017, all PPI injury lawsuits were consolidated for pretrial proceedings as part of MDL #2789 and transferred to the District of New Jersey to be overseen by Judge Claire C Cecchi. There are now roughly 14,000 cases filed in federal courts nationwide. The first of six scheduled bellwether trials is set to begin in January 2022. Judge Cecchi later postponed the first bellwether to October 2023. The trial did not move forward as AstraZeneca announced a it had agreed to pay $425 million to settle 11,000 lawsuits in the same month as the bellwether trial was supposed to take place. One single case remains pending in the US District Court of Middle Louisiana. That trial is set to move forward in April 2024.

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