Proton Pump Inhibitor (PPI) Lawsuits
Thousands of PPI lawsuits blame drugs such as Prilosec and Nexium for causing kidney disease, kidney failure and acute interstitial nephritis. Lawsuits against the makers of Prilosec, Nexium and other PPI brands claim manufacturers failed to warn of the dangers of proton pump inhibitors.
Why PPI Lawsuits Are Being Filed
More than 18,600 PPI lawsuits have been filed against the manufacturers of Nexium, Prilosec, Prevacid, Protonix and Dexilant for causing various health injuries. Individuals claim to have suffered kidney disease, kidney injury, kidney failure and acute interstitial nephritis.
The lawsuits argue that manufacturers didn’t do enough to warn patients and medical professionals about the possible risks as the companies became aware of them. Some Prilosec lawsuits allege that AstraZeneca knew of kidney risks for at least 10 years before warning the public.
|Drug Name (Generic Name)
|Prilosec OTC (omeprazole)
|Proctor & Gamble
All cases in the MDL claim the drugs, used to control stomach acid, caused serious side effects that damaged kidneys. Lawsuits involving Prilosec, for example, claim AstraZeneca knew of kidney risks as early as 2004, but the company did not warn patients about the risks for 10 years.
- Kidney disease
- Kidney injury
- Kidney failure
- Acute interstitial nephritis, or AIN
Latest PPI Lawsuit Updates
As of February 2024, 12,820 active PPI lawsuits were pending in federal court — out of a total of 18,668 that had been filed in the PPI litigation MDL 2789 in New Jersey. A judicial panel first combined the cases into multidistrict litigation, or MDL, in August 2017.
- May 2023: There were 12,949 active PPI lawsuits pending in federal court, down over 200 cases since last month. Lawyers were still speculating on a potential global settlement.
- April 2023: There were 13,205 active PPI lawsuits pending in federal court.
- February 2023: Judge Cecchi moved Rieder’s trial date to June 5, 2023.
- October 2022: The judge postponed the Rieder case until March 2023 but gave no reason for postponing it.
- August 2022: Special Master Reisman advised the MDL Judge that the Defendants’ preemption argument is invalid, and cases will proceed to trial.
- July 2022: James Rieder’s Nexium lawsuit is still heading for trial in November. But his breach of warranty and misrepresentation counts were dismissed.
- June 2022: Defendants tried to dismiss James Rieder’s chronic kidney disease lawsuit before it headed to trial in November 2022.
- May 2022: Defendants previously filed Motions for Summary Judgment and attempted to get cases thrown out based on federal preemption, and the Special Master issued CMO No. 75 to allow plaintiffs the opportunity to submit additional information.
- January 2022: Three bellwether trial dates were chosen, and the first Nexium lawsuit was set for trial on Oct. 12, 2022.
PPI Kidney Injury Lawsuits Consolidated
In October 2016, PPI users who filed six lawsuits against the drugs’ manufacturers asked a federal judicial panel to consolidate all federal kidney injury cases into a single multidistrict litigation.
At the time, 15 cases asserting similar claims were pending in 12 district courts. By February 2017, the number of related federal lawsuits had more than doubled, reaching 39. Complainants alleged they “suffered and continue to suffer from kidney injuries including but not limited to, acute interstitial nephritis, chronic kidney disease or renal failure known as end-stage renal disease, and acute kidney injuries,” according to the motion.
They further alleged that AstraZeneca, Takeda and Pfizer, along with others involved in the manufacturing of the drugs, failed to adequately warn about the risk of kidney injuries related to the use of Prilosec, Nexium, Prevacid and other PPIs.
“Given the widespread use of PPIs and their defective nature, it is likely that additional claimants will be harmed by the medications and additional similar actions will be filed in or removed to federal courts in the future,” Paul J. Pennock, Esq., of Weitz & Luxenberg, P.C., said in the plaintiffs’ motion.
The U.S. Judicial Panel on Multidistrict Litigation denied the MDL request in February 2017. In its order denying transfer, the panel said it recognized the lawsuits all arose from plaintiffs’ allegations that taking PPIs may result in various types of kidney injury, but the named defendants varied from action to action and are competitors. AstraZeneca was sued in most of the actions — 37, to be precise — but Proctor & Gamble was sued in only eight, Takeda in four, and Pfizer in two.
The panel also took issue with the variety of kidney injuries alleged and the differences among the drugs, including the different U.S. Food and Drug Administration approval times and the fact some are available over-the-counter while others require a prescription.
However, on Aug. 2, 2017, the judicial panel ordered the cases centralized in the District of New Jersey. Plaintiffs in 24 lawsuits had asked for the MDL the second time. There were 161 lawsuits pending — 60 in the District of New Jersey, which is more than in any other district. The panel also knew of 34 additional cases involving related issues. It assigned U.S. District Judge Claire C. Cecchi to oversee the proceedings.
- Harry Mason
- Harry Mason from Madison County, Illinois, filed the first federal kidney disease lawsuit against AstraZeneca in the U.S. District Court, Southern District of Illinois, in May 2016.
The Nexium lawsuit alleged the pharmaceutical company received complaints about Nexium’s link to kidney injury as early as 2004 yet continued to market the drug aggressively without adjusting its warning label.
Mason’s proton pump inhibitor lawsuit claimed that he began taking the medication in 2006, which led to chronic kidney disease and kidney failure. He was able to survive only after undergoing a kidney transplant.
His complaint stated that he was seeking actual and compensatory damages and punitive or exemplary damages. Mason voluntarily dismissed his Nexium lawsuit in March 2017, court records show.
- Jackie Koon
- In August 2016, Jackie Koon of Segwick County, Kansas, sued AstraZeneca over permanent kidney injuries she blamed on Prilosec.
Koon began using the medication in 2010 and continued taking it through 2013. She developed end stage renal disease, or ESRD. People with ESRD will die unless they have a kidney transplant or regular dialysis treatment for the rest of their lives.
Koon sought $10 million in the original complaint in her proton pump inhibitor lawsuit. She claimed the kidney damage caused her “physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.”
- Karen Vertrees
- Tennessee resident Karen Vertrees sued Takeda Pharmaceuticals in 2017, claiming the company’s Dexilant and Prevacid PPIs were responsible for her acute and chronic kidney injury.
Her lawsuit claimed she was prescribed both Takeda Pharmaceutical proton pump inhibitors “on numerous occasions” between 2001 and 2014.
The complaint in her Prevacid and Dexilant lawsuit said she would never have taken the drugs “had she been properly warned of the kidney risks associated with ingestion of these PPI’s.”
Nexium Lawsuits Filed Over Bone Fractures
Hundreds of consumers filed Nexium lawsuits against AstraZeneca, alleging the drug caused bone deterioration, loss of bone density and bone fractures. These Nexium lawsuits claimed the pharmaceutical company was aware of the risk of fractures but did not inform Nexium users.
However, a judge questioned the reliability of the expert testimony and said without it, the plaintiffs could not establish their cases. He ruled in favor of the defendants. After a few appeals, MDL-2404 IN RE: Nexium (Esomeprazole) Products Liability Litigation officially closed on Jan. 4, 2017, according to the U.S. Judicial Panel on Multidistrict Litigation website.
Despite this, some plaintiffs found success in these cases, including a class-action suit from 2014 that forced the FDA to require stricter warnings on the labels of Nexium and other proton pump inhibitors. Also in 2014, Takeda Pharmaceutical Company reached a settlement in Prevacid lawsuits that claimed a link between the drug and bone fractures. But the amount remains undisclosed.
PPI Lawsuits Over Misbranding, Deceptive Advertising and Kickbacks
PPI manufacturers also have faced lawsuits over complaints such as misbranding, deceptive advertising and kickbacks. Some of the complaints were brought forth as class-action lawsuits.
AstraZeneca Pays More Than $34 Million to Resolve Nexium Allegations
In 2015, AstraZeneca said it would pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium. The government claimed AstraZeneca worked with another company to boost Nexium sales.
AstraZeneca was the focus of a Nexium class-action lawsuit that claimed the company essentially paid off Teva Pharmaceutical Company to delay its release of a generic version of Nexium. Teva paid a $24 million settlement to the U.S. government, freeing itself from the case. In January 2015, Teva announced that the FDA had approved its generic equivalent of the drug.
Also in 2015, AstraZeneca agreed to pay the U.S. government and several states $26.7 million plus interest to settle claims that the pharmaceutical company underpaid rebates owed under the Medicaid Drug Rebate Program, according to the U.S. Justice Department.
Medco to Pay $7.9 Million to DOJ Over Prilosec Kickback Scheme
Medco Health Solutions Inc. agreed to pay the government $7.9 million over allegations it solicited kickbacks from AstraZeneca in the form of reduced prices on Prilosec, Toprol-XL and Plendil.
According to the government, this kickback arrangement between Medco and AstraZeneca violated the federal Anti-Kickback statute. The scheme caused the “submission of false or fraudulent claims for Nexium to the Retiree Drug Subsidy Program.”
“Pharmacy benefit managers that seek or accept kickbacks will be held accountable for their improper conduct,” Special Agent in Charge Nick DiGiulio of the U.S. Department of Health and Human Services-Office of Inspector General said in the DOJ’s 2015 statement.
Pfizer Agrees to Two Protonix Settlements Totaling $839 Million
In 2012, Pfizer agreed to pay $55 million plus interest to resolve allegations by the government that the company misbranded the drug. The government said Pfizer’s sales force promoted the medication to physicians for unapproved uses.
Sales reps were only supposed to market it for specific forms of gastroesophageal reflux disease, or GERD. However, the company trained its salespeople to push it for treatment of all forms of the condition, according to the U.S. Justice Department. It announced the settlement on Dec. 12, 2012.
AstraZeneca Pays $20 Million in Prilosec and Nexium Class Action Lawsuits
In February 2015, AstraZeneca agreed to pay $20 million to consumers in a Prilosec and Nexium class-action lawsuit that lasted for 10 years.
The class action claimed the company spent $260 million on an advertising campaign to mislead consumers into buying more expensive medicine. It accused AstraZeneca of attempting to “evergreen” the medicines. That is, the company tried to keep market share as a patent expired.
According to the lawsuit, AstraZeneca’s patent on Prilosec was about to expire, so the company pushed Nexium to replace it. The two drugs were almost chemically identical, but Nexium was far more expensive than Prilosec. Plaintiffs alleged the company’s marketing campaign tricked consumers into buying the more expensive Nexium rather than Prilosec, even though the drugs have the same effect.
Choosing a PPI Lawyer
An experienced proton pump inhibitor lawyer can help you file a comprehensive claim for all the damages you have incurred and make sure you receive a fair settlement or jury verdict. Make sure you choose a PPI lawyer with extensive experience in pharmaceutical litigation against large companies such as AstraZeneca and Pfizer. When choosing a PPI lawyer, make sure you ask about their track record in obtaining settlements or jury verdicts for their clients.
Drugwatch partners with the award-winning firm, Levin Papantonio Rafferty. The firm has been helping people injured by large corporations since 1955. They are recognized in the National Trial Lawyers Hall of Fame, Best Lawyers in America and SuperLawyers. The firm has won more than $30 billion in settlements and jury verdicts for their clients.
Questions Prilosec and Nexium Lawyers May Ask
What serious side effects did you experience after taking PPIs?
PPI side effects can range from minor to serious. The most frequently reported side effects are stomach pain, nausea and diarrhea. PPIs can also cause rare, but serious side effects, including kidney disease, kidney injury, kidney failure and acute interstitial nephritis.
Were you taking any other drugs at the same time you were taking PPIs?
PPIs can interact with more than 290 other medicines. At least 20 of these can cause severe reactions. Let your attorney know about other drugs you were taking while using PPIs.
How long did you take PPIs?
Long-term PPI use increases your risk for serious side effects. Bring a copy of your medical records to your lawsuit consultation so your attorney knows when you first started taking PPIs. Do your best to remember when you stopped taking them.
Have you had a kidney transplant or undergone dialysis?
People suffering from chronic kidney disease often have to undergo a kidney transplant or regular dialysis treatment. These procedures can take a physical, emotional and mental toll on your life. Make sure your attorney knows if you’ve undergone these procedures as part of your treatment plan.
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