About 15 million Americans take Proton Pump Inhibitors (PPIs) each year to treat common conditions such as gastroesophageal reflux disease (GERD), dyspepsia, acid reflux, and peptic or stomach ulcers. PPIs are available by prescription or over-the-counter, though the rise in PPI lawsuit filings suggest they are not without serious risk. People who take Proton Pump Inhibitors long-term may suffer kidney failure, bone fractures, pneumonia, or heart attacks. Worst of all, up to 70 percent of people taking PPIs get no benefit from them, and would be better off making lifestyle changes or using H2 blockers instead. PPI lawyers at Showard Law Firm are currently fielding claims from people who are interested in filing a heartburn medication lawsuit.
What is a Proton Pump Inhibitor?
Proton Pump Inhibitors work to limit the amount of acid produced by proton pumps in the stomach. Common names for PPIs include:
One of the undesired side effects of PPIs is that they can cause nutrient deficiencies when taken long-term. Pharmacy Times refers to PPIs as “nutrient robbers” because many users wind up with deficiencies in magnesium and B12.
PPIs and kidney injury
PPI kidney failure lawsuits are the most common type of proton pump inhibitors lawsuit, with more than 4,600 lawsuits pending in New Jersey. PPIs have been linked to kidney damage like inflammation, interstitial nephritis, and chronic kidney disease. With end-stage renal failure, patients cannot survive without dialysis or a kidney transplant. Many people who have kidney injury also suffer from complications like anemia, bone disease, high phosphorus, high potassium, fluid buildup, and heart disease.
A 2017 study of veterans published in the journal Kidney International found a link between PPI and kidney disease. According to researchers, there was a “statistically significant” 26 percent increase in chronic kidney disease for PPI users over patients on H2 blockers. Furthermore, veterans taking PPIs were 22 percent more likely to experience chronic kidney disease progression, and over 50 percent more likely to suffer end-stage renal disease.
FDA history with Proton Pump Inhibitors
Since 2007, there have been no major warnings or “black box” label updates recommended for Proton Pump Inhibitors, in spite of overwhelming evidence that taking PPIs may result in various kidney injuries. The FDA has made several general safety announcements to consumers over the years:
- 3/22/11: “As a precaution,” the FDA recommended a label update for the “drug facts” section to include information about a possible increased risk of fracture for patients 50 years of age or older taking prescription PPIs for at least one year or at high doses.
- 3/23/11: After investigating the possibility of increased hip, wrist, and spine fracture risk among PPI users, the FDA concluded no major label updates are required at this time, but patients should be aware the risk is greatest at high doses and among those using PPIs for more than a year.
- 2/8/12: A safety announcement alerted health care professionals and the general public that the use of PPIs “may be associated with an increased risk of Clostridium difficile-associated diarrhea.”
They add that “OTC PPIs are only intended for a 14-day course of treatment and can be used up to 3 times per year. Do not misuse, abuse, or take these medications for longer than stipulated on the label.”
Proton Pump Inhibitor litigation: MDL 2789
The first heartburn medication lawsuit was filed in the Western District of Tennessee against AstraZeneca’s Nexium in May 2016. The PPI kidney failure lawsuit alleged that the defendants knew or should have known about the significantly increased risk for kidney injuries and failed to adequately warn consumers. According to the complaint, Charles Bowers took Nexium from 2003 to 2008, when he was diagnosed with acute interstitial nephritis. As a result of his condition, Mr. Bowers was forced to undergo dialysis three times a week and is awaiting a kidney transplant.
In February 2017, the Judicial Panel of Multidistrict Litigation denied a motion to combine 39 cases into centralized proceedings, as they said the cases were too different. By the summer of 2017, there were more than 160 lawsuits filed against five PPI manufacturers.
Due to the overwhelming glut of similar cases, Multidistrict Litigation (MDL 2789) was finally approved to streamline proceedings. As of July 2018, 4,618 out of 4,644 PPI kidney failure lawsuits were still pending before U.S. District Judge Claire C. Cecchi in New Jersey, where more than 60 early suits were filed.
Unlike a class action lawsuit, each case will be heard individually following a series of bellwether cases that will expose the strengths and weaknesses for both sides of the argument. The first bellwether trial is scheduled for September 21, 2020.
PPI settlements and verdicts
To date, there have been no PPI verdicts or PPI settlements. As we wait for the first bellwether trial in 2020, more and more lawsuits continue to appear in courts across the country. The total number of cases is expected to reach 10,000 by that time. In addition, recent studies have suggested a possible link between stomach cancer and PPIs, so it is possible the scope of litigation may soon widen.
Contact PPI lawyers at Showard Law Firm
If you or a loved one has suffered kidney injuries as a result of PPI use, please call today to schedule your FREE consultation with one of the attorneys at Showard Law Firm to discuss the possibility of filing a PPI kidney failure lawsuit. Call (520) 622-3344 or toll free (866) 307-2147.
- CNN – Heartburn Medications and Infections, http://www.cnn.com/2010/HEALTH/05/10/heartburn.medicine.infections/index.html
- Renal and Urology News – Chronic Kidney Disease More Likely With PPIs, https://www.renalandurologynews.com/chronic-kidney-disease-ckd/chronic-kidney-disease-more-likely-with-proton-pump-inhibitors/article/640718/
- FDA – Safety Alert for Proton Pump Inhibitors, https://web.archive.org/web/20170112003839/http:/www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm213321.htm
- United States District Court, District of New Jersey, Proton-Pump MDL 2789, http://www.njd.uscourts.gov/proton-pump-mdl-2789
- British Medical Journal – Long-term Proton Pump Inhibitors and Gastric Cancer, https://gut.bmj.com/content/early/2017/09/18/gutjnl-2017-314605
A study released in 2016 by the Journal of American Society of Nephrology found that 96% of patients taking a PPI had an increased risk of developing kidney failure, and 28% of patients had an increased risk for developing kidney disease.