Proton pump inhibitors (PPI) are a classification of drugs used to treat and prevent heartburn, peptic ulcers, gastroesophageal reflux disease (GERD), and other health conditions related to excess stomach acid. The U.S. Food and Drug Administration (FDA) approved the first proton pump inhibitor drug in 1989. Long-term users of PPIs reported only mild side effects such as nausea, vomiting, dizziness, headache, and diarrhea for the first several years that brand name and over-the-counter proton pump inhibitors were on the market. Unfortunately, that is no longer the case.
PPI Drug Manufacturers Now Facing Recalls and Lawsuits
In April 2020, the FDA issued a voluntary recall notice for all proton pump inhibitors including the following brand name, generic, and over-the-counter medications in the PPI family:
- Prilosec OTC
The FDA recall notice came after several medical research studies linked the long-term use of proton pump inhibitors to an increased risk of kidney failure, bone fractures, acute interstitial nephritis, and other serious health conditions.
In 2015, AstraZeneca paid a $20 million dollar settlement to participants in a class action lawsuit. The plaintiffs claimed that AstraZeneca engaged in deceptive marketing practices by promoting Nexium as an improvement over Prilosec only because the patent for Prilosec had expired. The plaintiffs suffered serious side effects rather than improved health results.
Thousands of Americans have now filed a proton pump inhibitor lawsuit against AstraZeneca, Pfizer, and other PPI manufacturers since 2015. Due to the large volume of PPI lawsuits, many plaintiffs have chosen to become part of a multidistrict litigation (MDL) for the sake of efficiency.
MDL differs from a class action lawsuit in that it consolidates similar PPI lawsuit cases from across the United States into a single court. However, each plaintiff in an MDL is a separate case. District courts combine the proceedings to prevent backlogs due to the volume of PPI lawsuits filed. Both an MDL and a class action lawsuit represent mass tort legal actions. A mass tort is a civil action involving multiple plaintiffs against a single defendant or a few defendants in some cases.
PPI Manufacturers Covered Up the Known Risk of Serious Side Effects for Years
Plaintiffs in MDL cases against PPI manufacturers claim that the defendants have known about the risk of chronic kidney disease and other serious side effects for years but chose to withhold that information from the public. Medical research from multiple sources backs up this claim.
The first indication of problems for PPI manufacturers came in 1992, just three years after the FDA approved the medication. Researchers from the University of Arizona published an article in the American Journal of Medicine proving a link between long-term use of PPIs and kidney damage. The 1992 study determined that omeprazole, which is the active ingredient in brand name Prilosec and other PPIs on the market at that time, could cause acute kidney injury in patients who took the drug at high doses or for a period of more than one year.
Several other medical researchers made the same claim as the University of Arizona in 1997. They published their findings in the Journal of the American Medical Association (JAMA). In 2009, the medical journal Hospital Physician declared long-term use of PPIs as the leading cause of acute interstitial nephritis, a serious kidney disease that can develop into renal failure.
In more recent medical research, JAMA Internal Medicine published a study in 2016 linking long-term use of PPIs to chronic kidney disease. According to the publication, adults using proton pump inhibitors for one year or longer have up to a 50 percent increased risk of developing serious kidney problems up to and including end-stage kidney failure.
The JAMA Internal Medicine study did not determine any increased risk of serious side effects with H2 blockers. H2 blockers are an alternative classification of brand name and over-the-counter drugs used to treat disorders caused by overproduction of stomach acid.
In late 2019, the FDA determined that several PPI manufacturers had an unsafe level of n-nitrosodimethylamine (NDMA) in stored medications. While the FDA considers trace amounts of NDMA in food, water, and certain products an acceptable risk, the amount present in some brand name, generic, and over-the-counter PPIs was high enough to prompt the April 2020 FDA recall notice. The Agency for Research on Cancer (ARC) has labeled NDMA a probable human carcinogen, which means that long-term use of PPIs poses an increased risk of cancer.
Do You Qualify to File a Proton Pump Inhibitor Lawsuit?
The first step in determining if you qualify to join a class action or MDL proton pump inhibitor lawsuit is to determine which medication you took, why you took it, and whether you experienced serious health complications because of it. Typically, doctors prescribe proton pump inhibitors to treat these conditions:
- Acid reflux
- Erosive esophagitis
- Peptic ulcers
- Zollinger-Ellison syndrome
Keep in mind that you could still qualify to participate in a proton pump inhibitor lawsuit even if we did not list your specific health condition. Doctors prescribed proton pump inhibitors for a wide range of gastrointestinal health conditions related to overproduction of stomach acid. You could also qualify to participate in a class action lawsuit or MDL if you do not see the brand name, generic, or over-the-counter medications listed above as long as it meets the description of a proton pump inhibitor.
The next step is to determine if a relationship exists between the proton pump inhibitor you took and any serious side effects that you experienced. The following are just some of the complications reported by PPI users who used heartburn drugs for longer than one year:
- Acute interstitial nephritis (AIN)
- Acute kidney injury
- Bone fractures
- Cancer of the esophagus
- Chronic kidney disease (CKD)
- End stage renal disease (ESRD)
- Gastric Cancer
- Heart attack
- Increased risk of dementia
- Low magnesium levels
- Need for a kidney transplant
If you believe that you qualify to participate in a proton pump inhibitor lawsuit, you must initiate your mass tort claim before the statute of limitations for injury lawsuits expires in your state. Each state sets its own statute of limitations with the range running from two to six years from the date you sustained a serious injury or illness due to another party’s negligence.