Proton pump inhibitors (PPIs) such as Prilosec, Prevacid and Nexium are blamed in hundreds of lawsuits for causing kidney damage or injuries.
If you took a Proton Pump Inhibitor (PPI) like Nexium or Prilosec and suffered one of the following side effects, you may be entitled to compensation.
Number of Lawsuits Hundreds of active lawsuits
Plaintiff Injuries Kidney injury; bone injury; low magnesium levels; food poisoning
Defendants AstraZeneca Pharmaceuticals LP; Takeda Pharmaceuticals USA Inc.; Pfizer Inc.; Proctor & Gamble
Litigation Status Active
Class-Action Status Inactive
Top Settlement $55 million
Heartburn sufferers spend $10 billion a year on PPIs. Originally sold by prescription only, many PPIs are now available over-the-counter (OTC) and in generic or store-brand versions. The popular heartburn drugs are among the most widely consumed medications in the U.S.
Multiple studies since Prilosec, the first PPI, hit the market have associated the heartburn medications with an increased risk of serious kidney problems. Despite mounting scientific evidence of potential side effects leading to kidney disease or damage, PPIs were widely sold for 18 years before their labels were forced to carry a warning of the risks.
Since 2016, people have filed hundreds of lawsuits claiming Prilosec, Prevacid, Nexium and other heartburn medicines caused kidney disease, damage or injuries and that manufacturers have failed to warn people about the risk for years.
The American Journal of Medicine published the first case study linking PPI use to kidney injuries in 1992
More than 270 of kidney complication lawsuits have been combined in a federal multidistrict litigation (MDL) in New Jersey. MDLs allow several similar cases to move more quickly and efficiently through the legal process. Lawyers expect thousands of cases may eventually be included in the proton pump inhibitor MDL.
First Nexium kidney damage lawsuits are filed against AstraZeneca
U.S. Judicial Panel on Multidistrict Litigation (JPML) denies motion to combine 39 federal lawsuits against various PPI manufacturers into a single MDL
JPML reconsiders request to combine 163 lawsuits against five heartburn drug manufacturers into an MDL
JPML centralizes 161 PPI cases into one action in a New Jersey federal court
Total number of cases in MDL grows to 522
The lawsuits being added to the multidistrict litigation (MDL) in New Jersey claim Prilosec, Nexium and other PPIs caused kidney-related complications. People suing these heartburn drug manufacturers claim they “suffered and continue to suffer” from serious kidney injuries or damage.
Some of the lawsuits were filed by people who developed kidney complications themselves after taking PPIs. Other lawsuits were filed by family members after an immediate relative died from kidney problems after taking the heartburn drugs.
Lawsuits over kidney-related complications claim that Prilosec manufacturer AstraZeneca knew of possible kidney risks as early as 2004, but never warned patients about the danger. PPI labels did not warn of AIN risks until the FDA required that labels include it starting in 2014.
The proton pump inhibitor MDL involves four manufacturers and five specific brands of heartburn medications.
|Prilosec OTC||Proctor & Gamble|
The current proton pump inhibitor MDL is still in the very early stages, so there have been no verdicts or settlements yet. But past heartburn drug lawsuits for other causes have included a $55 million settlement. Most settlements so far have resulted from lawsuits brought by the government over PPI manufacturers’ business practices.
Pfizer agrees to settlement with U.S. government for promoting Protonix for unapproved uses
Takeda Pharmaceuticals settles a lawsuit claiming Prevacid was responsible for bone fractures
AstraZeneca agrees to a settlement in a consumer class action lawsuit involving its marketing of Prilosec and Nexium
AstraZeneca agrees to settlement with U.S. government over alleged kickback scheme involving Nexium
Generic drug maker Teva Pharmaceuticals settles lawsuit claiming it took money from AstraZeneca to keep generic Nexium off the market
AstraZeneca paid $20 million in 2015 to settle a class action lawsuit involving two PPIs the company manufactured – Nexium and Prilosec.
The class action lawsuit accused AstraZeneca of attempting to “evergreen” the drugs. It claims that as AstraZeneca’s patent on Prilosec was running out, the company created Nexium — a new, nearly identical drug that was much more expensive — to replace it.
In the class action lawsuit, consumers claimed the company’s $260 million marketing campaign tricked people into buying the more expensive Nexium rather than Prilosec, even though the drugs had the same effect.
Scientific studies and federal safety warnings have highlighted the possibilities of other serious side effects related to PPIs.
FDA requires bone fracture risk added to PPI labels
The first wave of individual lawsuits over the heartburn drugs claimed PPIs such as Nexium had caused or contributed to bone fractures and other bone conditions.
First Nexium lawsuit is filed against AstraZeneca, claiming it led to a woman’s bone fractures
The U.S. Judicial Panel on Multidistrict Litigation (JPML) combines 47 Nexium lawsuits in a single multidistrict litigation (MDL) in a California federal court
MDL grows to more than 1,000 lawsuits against AstraZeneca
The MDL judge closes the MDL in favor of AstraZeneca
Takeda Pharmaceuticals settles bone fracture lawsuit naming Prevacid for an undisclosed amount
More recently, research has indicated PPIs increase the risk of serious kidney damage or injury. In December 2014, the FDA required PPI manufacturers to add warnings to their product labels about the risk of acute interstitial nephritis.
FDA revises labels for PPIs to include safety information about a possible increased risk of fractures of the hip, wrist and spine
FDA safety communication warns of possible low magnesium levels for people taking PPIs for a year or longer – risking muscle spasms and irregular heartbeat
FDA warns that PPI use can lead to Clostridium difficile-associated diarrhea, which can lead to more serious intestinal conditions
The agency warns that taking PPIs for three years or longer can lead to Vitamin B12 deficiency, associated with memory loss
FDA requires warning of increased risk of acute interstitial nephritis be added to PPI labels
FDA approves PPI label changes to include risk of lupus erythematosus – a condition in which the body’s immune cells attack other cells or organs in the body
Though current lawsuits target kidney-related injuries and past suits were about bone fractures, recent studies suggest PPIs may be responsible for other serious complications.
|Side Effect Investigated||Date of the Study||What Researchers Found About PPI Users|
|Heart Attack||June 2015||Heart attack rate increased from 16 to 21 percent according to a study in the journal PLOS One|
|Stroke||November 2016||A study presented at the 2016 American Heart Association's Scientific Sessions found a 21 percent increased stroke risk|
|Gastric Cancer||September 2017||A study published in the BMJ journal Gut found the risk of gastric cancer doubled for patients with previous Helicobacter pylori infections|
No lawsuits have been filed over these side effects yet, but as more PPI research emerges, attorneys say more people injured by these drugs may seek compensation through the courts.
Please seek the advice of a medical professional before making health care decisions.
Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.
Did you suffer kidney problems after taking a proton pump inhibitor?