By Mike Papantonio, Trial Attorney and Legal Expert.
Prevacid lawsuits stem from patients experiencing a high risk of serious side effects like kidney disease and bone fractures. Patients claim the manufacturer failed to warn them of these side effects, and have filed 13,900+ lawsuits against Prevacid and other proton-pump inhibitors.
Why People are Filing Prevacid Lawsuits
Prevacid is a popular proton pump inhibitor, sometimes referred to as PPIs, manufactured by Takeda Pharmaceuticals. The drug was created with active ingredient lansoprazole, which is used to treat various conditions caused by too much acid in the stomach. The product is in the form of a slow-release capsule or tablet taken once daily over the course of two weeks. The course of treatment can be repeated every four months, depending on the health condition.
Conditions Treated by Prevacid
- Frequent heartburn
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Erosive esophagitis
- Ulcers in the lining of the stomach or intestine
- Ulcers caused by an infection with H. pylori bacteria (in combination with antibiotics)
The U.S. Food and Drug Administration (FDA) approved the drug back in 1995 and it quickly grew in popularity – especially when an over-the-counter version, Prevacid 24HR, was released in 2009. In recent years, however, researchers have discovered a link between the medication and severe health issues. On its label, Prevacid only warns consumers of possible diarrhea, abdominal pain, nausea, constipation, possible bone fracture and hypomagnesemia, though recent studies have found much more serious risks.
Prevacid and Kidney Problems
The majority of Prevacid lawsuits and other PPI lawsuits have been filed because consumers have faced varying short-term and chronic kidney diseases after taking the medication, whether prescribed or in over-the-counter forms.
Numerous studies have emerged linking Prevacid, as well as Astrazeneca’s Nexium and Prilosec, to an increased risk of developing kidney conditions. Consumers have seen a spectrum of minor kidney injuries like acute interstitial nephritis (swelling of the kidney tubules that can become more severe) and chronic kidney disease, which may result in kidney failure and even death. One recent study published in JAMA discovered that participants regularly taking Prevacid and similar drugs had a 20 – 50% higher risk of developing chronic kidney disease than nonusers.
Another related study found that even short-term or acute kidney injury from taking Prevacid may not be the whole picture of continued declining kidney function. The researchers noted that patients in the study silently and gradually developed worsening kidney problems, which led to some facing chronic kidney disease or renal failure. Although 80% of PPI users had not been diagnosed with acute kidney disease in their follow-ups over five years, more than half of the cases of chronic kidney disease or kidney failure were found in patients without acute kidney problems.
In instances of kidney or renal failure, patients may experience weakness, swelling, high blood pressure, and abnormal heart rhythms. The condition may be fatal unless the patient goes on dialysis or has a kidney transplant. Researchers urge doctors to closely monitor kidney function for all patients on Prevacid and similar medications, especially those who take the drug for a year or longer.
Other Health Risks of Taking Prevacid
Prevacid and its competitors have been linked to a number of other serious health problems. Though further study is needed to better understand these risks, there is enough evidence available to cause concern.
Prevacid has been linked to low magnesium levels, an increased risk of gastric or stomach cancer, as well as a 21% increase in the risk of stroke and heart attacks. Proton pump inhibitors have additionally been linked to an increased risk of bone fractures, particularly in the spine, wrist or hip.
Prevacid’s main ingredient, lansoprazole, has also been linked to several skin conditions, including itching, rashes, and exfoliative dermatitis. This condition, also known as erythroderma, is when the skin becomes red and irritated and begins to peel off over large areas of the body. The condition is uncommon but can be life-threatening in the most severe cases.
Researchers have also explored the possibility of sudden, early death from taking these drugs. One startling study compared patients taking proton pump inhibitors over the course of one to two years against patients taking H2 blockers, another type of drug that treats conditions caused by excess stomach acid. Researchers found that consumers of PPIs faced a 50% increased chance of death within the next 5 years compared to those on H2 blockers because of the serious side effects, like gradual kidney damage.
The researchers further calculated that for every 500 consumers relying on Prevacid or another proton pump inhibitor for one year, there is one additional death that would not have otherwise happened. With millions of people regularly using these drugs, this could translate to thousands of entirely preventable deaths every year.
As with many product liability lawsuits, plaintiffs are also taking aim at the manufacturer’s apparent negligence and false advertising. Some of the risks associated with Prevacid, Prilosec, and other heartburn drugs are due to the difficulty for doctors to monitor if patients are taking the medications as directed and the duration of treatment. Even so, part of the problem stems from doctors and patients alike not fully understanding the risks.
Many cases claim that Takeda should have done more testing of the drug and made the public more aware of these possible risks, especially for those who rely on the drug for a longer period of time. Ultimately, Takeda and many drug manufacturers are often accused of pushing sales of defective or dangerous products because it helps their profits. With the severe risk factors coming to light, however, the company has seen a decrease in Prevacid sales over the last several years.
Prevacid lawsuits, as well as other proton pump inhibitor lawsuits, have increased significantly in the past couple years, with more than 13,000 lawsuits currently pending under MDL 2789 IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II), according to the most recent report.
MDL 2789 was formed in August 2017, transferring 161 lawsuits against proton pump inhibitors to the United States District Court of New Jersey. These cases will be overseen by Judges Claire Cecchi and Mark Falk. The first bellwether trial is set to begin in September 2020; these will serve as test runs to better understand the complexities of these cases and make for a smoother process for the remaining lawsuits.
While there have been class action lawsuits filed against AstraZeneca in regard to Nexium and Prilosec, there aren’t currently any class action lawsuits against Prevacid.