Thousands of proton-pump inhibitor lawsuits have been filed by patients. The manufacturers of Prilosec and Nexium face many of these lawsuits. Plaintiffs claim the drugs cause serious side effects like stroke, heart attack and kidney problems. One manufacturer, AstraZeneca, has settled a class action lawsuit for $20 million. But, there are still more than 13,000 proton-pump inhibitor lawsuits pending in federal court.
Why People are Filing Nexium and Prilosec Lawsuits
Prilosec (omeprazole) is a proton-pump inhibitor (PPI) developed by manufacturer AstraZeneca. Prilosec is prescribed to block excess stomach acid from causing painful heartburn. It is a delayed-release drug. Prilosec was the first of its kind approved by the U.S. Food and Drug Administration (FDA) in 1989 for prescription use. It was also the first in its class to be approved for over-the-counter sale in 2003, under the name Prilosec OTC.
Nexium is a second-generation heartburn drug made by the same manufacturer. The FDA approved Nexium in 2001. Instead of using omeprazole, AstraZeneca used esomeprazole as the active ingredient in the drug. The two molecules are closely related.
Reports have shown the manufacturer likely developed the drug to stay in the billion-dollar heartburn medication industry. The patent for Prilosec ran out in 2002. Nexium helped maintain the company's profits as the Prilosec patent expired.
Conditions Treated by Prilosec and Nexium
- Acid reflux or gastroesophageal reflux disease (GERD)
- Gastric ulcers
- Duodenal ulcers
- Erosive esophagitis
- Zollinger-Ellison syndrome (long-term treatment)
AstraZeneca altered the drug formulation, using omeprazole magnesium for Prilosec OTC. The tablets are meant to be taken over the course of 14 days to gradually improve heartburn. This dose can be repeated every four months.
The over-the-counter version of Nexium is known as Nexium 24HR. Nexium 24HR wasn't available until 2014. Similarly, AstraZeneca changed the formulation to esomeprazole magnesium. Like Prilosec OTC, Nexium 24HR can be taken for up to 14 days. The treatment can also be repeated every four months.
AstraZeneca initially warned consumers of some potential side effects such as:
- Stomach pain
- Allergic reactions
However, as the drug grew in popularity, researchers realized the risks were far more serious than they originally seemed.
Nexium and Prilosec Dangers
Millions of people rely on Prilosec and Nexium to treat frequent heartburn and other conditions each year. But, recently, many studies have been published around the serious side effects of Prilosec, Nexium and their main ingredients.
Several of these studies came out around 2010. The results of the studies indicated an increased risk for bone fractures in the hip, wrist and spine when the PPIs were used over a long period of time.
Researchers were split on the evidence. The FDA ultimately determined a year later that those who use only a low dose of the drug over one year or less are not at risk. The agency concluded an additional safety warning did not need to be added at the time. But, in recent years, more dangerous Prilosec and Nexium side effects have come to light.
Dangerous Side Effects of Nexium and Prilosec
- Short-term kidney problems
- Acute kidney injury
- Acute interstitial nephritis (AIN)
- Low magnesium levels
- Heart Attack
A 2016 study published in JAMA Internal Medicine observed nearly 11,000 participants taking Prilosec and other PPIs. They found use of PPIs carried a 20 - 50% higher risk of chronic kidney disease compared to non-users. Chronic kidney disease can progress over time, severely decreasing kidney function. This can potentially lead to kidney failure (renal failure) and the need for a kidney transplant.
Other studies have seen additional serious health effects. One recent study determined the use of Prilosec and Nexium could lead to an increased risk of gastric cancer. Researchers found the risk more than doubled for patients who had previous infections in the stomach.
Other studies have determined:
- The overall risk for stroke increases by 21% for users.
- The risk for a heart attack increases to upwards of 21% for long-term users.
- Regular omeprazole has been associated with more than double the risk of dementia for seniors.
The plaintiffs allege manufacturer AstraZeneca did not properly test the drugs for side effects. Additionally, the drug manufacturer didn't appropriately warn doctors and consumers of the potential health risks.
The FDA has released new warnings over the years in correlation with many of the studies mentioned above. However, AstraZeneca continues to market both drugs heavily. There was even an apparent shortage of Prilosec OTC in the early 2000s.
Prilosec was one of the company's best selling drugs. It accounted for billions of dollars of revenue each year. This may be one reason why AstraZeneca continued to falsely advertise the effectiveness and safety of the drug.
The company lost patent protection in 2002, after which the company furthered their deception. AstraZeneca began encouraging Prilosec patients to use its next-generation drug, Nexium. The company claimed Nexium, which leads to the same severe side effects as Prilosec, was safer and more effective than Prilosec. They also allegedly bribed health company Medco into advertising and discounting the newer drug to boost sales.
As a result, AstraZeneca was required to pay the United States Department of Justice $7.9 million for its Prilosec and Nexium kickback scheme.
AstraZeneca Class Action Lawsuit
In 2015, AstraZeneca settled a class action lawsuit that involved Prilosec and Nexium. Consumers claimed that the drug company was trying to boost sales of Nexium as their patent for Prilosec ran out. Chemically, the drugs are nearly identical, but Nexium was much more expensive.
The class action lawsuit claimed AstraZeneca created a deceptive marketing campaign in an attempt to make the drugs "evergreen" and manipulate their own bottom line. The case ended with a Prilosec lawsuit settlement of $20 million paid out to the plaintiffs. Meanwhile, thousands of additional PPI lawsuits have been filed against the company and other drug manufacturers in state and federal court.
Prilosec and Nexium Lawsuits
There were several attempts to transfer these proton-pump inhibitor lawsuits to a singular multidistrict litigation (MDL). An MDL is a special federal process to streamline and speed up the handling of these cases. Initially, the U.S. Judicial Panel on Multidistrict Litigation denied the motion to combine 39 federal lawsuits against various PPI manufacturers into a single MDL in February 2017. As the number of cases grew, the panel later reconsidered. MDL 2789 officially formed in August 2017.
The Proton-Pump MDL 2789 lawsuits are being overseen by Judge Claire Cecchi and Judge Mark Falk in the United States District Court of New Jersey. When the MDL initially formed, 161 cases were transferred. As of November 2020, there are more than 13,000 lawsuits pending. The first of the bellwether trials was scheduled for September 21, 2020. However, COVID-19 may push this bellwether trial out to a later date.
Prilosec and Nexium Lawsuit FAQ's
Am I Eligible to File a Prilosec or Nexium Lawsuit?
If you or a loved one have taken Prilosec, Prilosec OTC, Nexium or Nexium 24HR and suffered kidney damage or other serious side effects, you may be eligible to file a claim.
What Compensation Can I Receive for a Nexium or Prilosec Lawsuit?
Compensation in similar prescription drug lawsuits generally looks at the legal damages incurred because of the drug. These often include:
- Medical expenses
- Loss of income
- Pain and suffering
Each case is unique. Therefore the compensation awarded may vary slightly in cases tried individually or within federal litigation.
How Can I Pay for a Prilosec or Nexium Lawyer?
If you file a claim with a contingency agreement, you won't be required to pay any expenses upfront. You will only be asked to pay if your case is successful.