Heartburn drugs Nexium, Prilosec, and Prevacid were alleged to cause serious kidney injury in one of the larger pharmaceutical MDLs. Here is what the litigation claimed, how AstraZeneca's $425 million settlement fits in, and where the science stands.
Allegations Only · Settled Without Admission
This page describes litigation and an investigation. The statements below are unproven allegations. The manufacturers denied that their drugs cause kidney injury and settled without any admission of wrongdoing; a court never issued a final ruling on whether PPIs cause these injuries. This page is informational and is not legal or medical advice. Do not stop taking any prescribed medication without consulting your doctor.
What Is This About?
Proton-pump inhibitors (PPIs) are among the most widely used heartburn and acid-reflux medicines in the world — sold under brand names such as Nexium, Prilosec, Prevacid, Dexilant, and Protonix. Beginning around 2017, thousands of patients filed lawsuits alleging that long-term PPI use caused serious kidney injury and that the manufacturers failed to adequately warn of the risk.The federal cases were consolidated in multidistrict litigation known as MDL 2789, In re: Proton-Pump Inhibitor Products Liability Litigation (No. II), before Judge Claire C. Cecchi in the U.S. District Court for the District of New Jersey. Unlike some pharmaceutical MDLs that collapsed after an adverse expert ruling, this litigation matured into settlements: the major defendants agreed to resolve their cases, and the MDL is now winding down through settlement administration.
The claims were allegations that were never proven in court. The manufacturers deny that PPIs cause kidney injury.
Which Heartburn Drugs Are Involved?
The litigation focuses on proton-pump inhibitors and their manufacturers. Verifying which company makes which brand matters, because the settlements were reached defendant by defendant:• Nexium (esomeprazole) and Prilosec (omeprazole) — AstraZeneca (Prilosec OTC is marketed by Procter & Gamble; Nexium 24HR by consumer-health companies).
• Prevacid (lansoprazole) and Dexilant (dexlansoprazole) — Takeda.
• Protonix (pantoprazole) — Pfizer / Wyeth.
• Generic PPIs — various generic manufacturers.
(Takeda is a Japanese pharmaceutical company and is unrelated to the airbag maker Takata.)
What Kidney Injuries Were Alleged?
Plaintiffs alleged that long-term or regular PPI use can cause a progression of kidney harm:• Acute interstitial nephritis (AIN) — inflammation of the kidney's filtering tissue
• Acute kidney injury (AKI)
• Chronic kidney disease (CKD)
• End-stage renal disease (ESRD)
The alleged mechanism runs from AIN or AKI toward chronic and, in the worst cases, end-stage disease. In December 2014, the FDA added an acute-interstitial-nephritis warning to the PPI class labeling. Plaintiffs alleged the manufacturers knew of the kidney risks and failed to warn — a product-liability failure-to-warn theory. None of this was adjudicated as fact.
The Science Dispute
The litigation grew out of observational epidemiology. A widely cited 2016 study in JAMA Internal Medicine (Lazarus and colleagues) and a separate 2016 study of U.S. veterans (Xie and colleagues) reported an association between PPI use and chronic kidney disease and other kidney outcomes.The central dispute was whether those studies could establish general causation — whether PPIs actually cause the injuries, as opposed to being statistically associated with them. The defendants argued that observational studies cannot prove causation because of confounding and study design; the plaintiffs argued the overall body of evidence, together with the recognized AIN mechanism, was enough. Because the defendants settled before the court issued a final general-causation decision, this scientific question was never resolved on the merits.
The Settlements
The MDL is resolving through settlements rather than trials:• AstraZeneca agreed in October 2023 to a settlement reported at about $425 million to resolve roughly 11,000 Nexium and Prilosec kidney-injury claims, with payments reported to roll out over the following years.
• Other manufacturers — including GlaxoSmithKline, Procter & Gamble, Pfizer, and Takeda — reached separate settlements to resolve their portions of the litigation.
All of these resolutions were reached without any admission of wrongdoing. Because the settlements are administered confidentially through claimants' attorneys, there is no public claim form on this page. Anyone who believes they may have an unresolved claim should consult an attorney promptly, as statutes of limitations and any remaining settlement windows vary. (Note: an unrelated 2016 government settlement over Protonix drug-pricing is a separate matter and is not part of this kidney-injury litigation.)
Frequently Asked Questions
Which heartburn drugs are in the PPI kidney lawsuit?
The litigation involves proton-pump inhibitors (PPIs): Nexium and Prilosec (AstraZeneca), Prevacid and Dexilant (Takeda), and Protonix (Pfizer/Wyeth), along with certain generics. Prilosec OTC is marketed by Procter & Gamble and Nexium 24HR by consumer-health companies. These are prescription and over-the-counter heartburn medicines.
What kidney injuries were alleged?
Plaintiffs alleged that long-term or regular PPI use can cause acute interstitial nephritis (AIN), acute kidney injury (AKI), chronic kidney disease (CKD), and end-stage renal disease (ESRD). These were unproven allegations; the manufacturers denied that the drugs cause these injuries.
Is there a PPI kidney settlement?
Yes, in part. In October 2023 AstraZeneca agreed to a $425 million settlement resolving roughly 11,000 Nexium and Prilosec kidney-injury claims, and other manufacturers reached separate settlements. The settlements were reached without any admission of wrongdoing, and there is no public claim form on this page; the MDL is winding down through settlement administration.
Do PPIs definitely cause kidney disease?
That was never resolved by a court. Observational studies, including a 2016 JAMA Internal Medicine analysis, reported an association between PPI use and kidney outcomes, but association is not the same as proven causation. Because the defendants settled before a final general-causation ruling, the scientific question was not decided on the merits. Do not stop taking a prescribed medication without consulting your doctor.
Related Mass Torts & Sources
• Zantac (ranitidine) cancer lawsuit — another major heartburn-drug mass tort, with a $2.2B GSK settlement.• Ozempic / GLP-1 gastroparesis lawsuit (MDL 3094) — a related drug-injury investigation.
• Bard / Davol hernia mesh lawsuit (MDL 2846) — a large medical-device MDL.
Primary sources: U.S. Judicial Panel on Multidistrict Litigation (JPML) pending-MDL statistics; the U.S. District Court for the District of New Jersey MDL 2789 docket; reporting by Forbes and FiercePharma on the AstraZeneca $425M settlement; and Lazarus et al., JAMA Internal Medicine (2016).
Important Disclosures
This page is for general informational purposes and does not constitute medical or legal advice. Do not stop taking any prescribed medication without consulting your physician. You should consult a qualified attorney about your individual situation. OpenClassActions.com is not a law firm and is not a claims administrator, and this page does not create an attorney-client relationship.Free settlement alerts
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