Pharmaceutical Lawsuits
Proton Pump Inhibitor Kidney Claims: What MDL 2789 Shows
A factual review of the PPI kidney injury litigation: the 2017 federal consolidation, the recorded 2023 master settlement, and what remains undecided.
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Proton pump inhibitors are prescription medicines that suppress gastric acid secretion. The federal lawsuits collected as MDL No. 2789, In re: Proton-Pump Inhibitor Products Liability Litigation (No. II), concern kidney injuries that plaintiffs attribute to the drugs. The Judicial Panel on Multidistrict Litigation transferred the actions to the District of New Jersey by an order dated August 2, 2017, and the cases are assigned to Judge Claire C. Cecchi. The Panel’s report dated October 1, 2026 lists 11,404 actions pending of 18,755 filed. A docket control order the court entered on October 2, 2023 records a master settlement agreement between plaintiffs and the AstraZeneca and Merck defendants, entered without admission of fault or liability. No court in the documents reviewed for this article has found that a PPI caused any individual’s kidney injury.
What is established versus what is alleged
The omeprazole label describes the drug class as substituted benzimidazoles that suppress gastric acid secretion by inhibiting the H+/K+-ATPase enzyme system. The FDA approved omeprazole for several acid-related conditions, including duodenal ulcer, Helicobacter pylori eradication in combination with antibiotics, reflux disease and erosive esophagitis. The label also warns about Clostridium difficile-associated diarrhea, bone fracture, low magnesium and vitamin B-12 deficiency, among other risks. MDL No. 2789 exists, it sits in the District of New Jersey before Judge Cecchi, and the Panel’s October 1, 2026 report counts 11,404 actions pending of 18,755 filed.
What remains alleged: that PPI use causes chronic kidney disease, that the defendants’ warnings were inadequate, and that any particular plaintiff’s kidney injury was caused by a PPI. The court’s docket control order describes the study that preceded the litigation as reporting an association between PPI use and chronic kidney disease. An association reported in an epidemiological study is not a finding of causation, and the order does not treat it as one.
What the FDA label says about the kidneys
The prescribing information for PRILOSEC (omeprazole magnesium) delayed-release granules, revised in March 2024, addresses the kidney in one warning section. Under the heading “Acute Tubulointerstitial Nephritis” it states: “Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy.” It directs prescribers to discontinue the drug and evaluate patients with suspected acute TIN.
That warning concerns acute tubulointerstitial nephritis. The version reviewed for this article contains no warning section for chronic kidney disease, the condition the court’s order identifies in the study that preceded the litigation.
A label warning is a regulatory action, expressed through approved prescribing information. It is not a judicial finding that the drug caused any person’s injury, and it does not decide the claims in the MDL.
How the litigation reached its current posture
The Panel’s transfer order is dated August 2, 2017, according to the court’s initial case management order, which was filed on August 23, 2017. That order established master docket 2:17-md-02789, appointed Christopher Seeger as interim lead counsel for plaintiffs, and scheduled the initial case management conference for September 12, 2017.
Case Management Order No. 100, entered June 15, 2023 with the parties’ consent, set an expert deposition protocol for the Wave One cases and referred to an earlier “Bellwether One” case. It is a scheduling order and decides no claim.
Case Management Order No. 109, entered October 2, 2023, is the most detailed statement of posture in the record reviewed. The court wrote that “without admission of fault or liability, the AstraZeneca and Merck Defendants have entered into a Master Settlement Agreement to resolve cases alleging personal injury (and related) claims against them related to PPI products.” The order records that more than 18,600 cases had been filed in the MDL over the preceding six years, approximately 17,950 of them against those defendants.
The same order applies to plaintiffs who are not settling under the voluntary settlement program. It requires them to produce medical records and expert reports within 90 days, with dismissal with prejudice as the consequence of unexplained noncompliance. It also provides expedited, bifurcated discovery on time-based defenses and causation. It separately provides for litigation against any remaining defendants not subject to settlement agreements or a stay.
Key dates
- January 2016: a study by Lazarus et al. is published in JAMA Internal Medicine. The court describes it as reporting an association between PPI use and chronic kidney disease (Case Management Order No. 109).
- August 2, 2017: the Panel’s transfer order creates MDL No. 2789.
- August 23, 2017: the initial case management order is filed and establishes master docket 2:17-md-02789 (initial case management order).
- June 15, 2023: the court enters Case Management Order No. 100, the Wave One expert deposition protocol.
- October 2, 2023: the court enters Case Management Order No. 109, which records the master settlement agreement with the AstraZeneca and Merck defendants, without admission of fault or liability (Case Management Order No. 109).
- March 2024: the omeprazole prescribing information reviewed for this article is revised (DailyMed label).
- October 1, 2026: the Panel reports 11,404 actions pending of 18,755 filed in MDL No. 2789 (JPML statistics report).
What this does not establish
Nothing in the documents reviewed here shows a court finding that a proton pump inhibitor caused any individual’s kidney injury, that the defendants’ warnings were inadequate, or that any plaintiff is entitled to compensation. Those remain allegations. The 2023 settlement was entered without admission of fault or liability, and the order recording it does not state its terms or amounts.
The record contains no trial verdict in the MDL and no final approval order for the settlement. A pending count measures open dockets. It does not measure merit, and it does not show how actions that are no longer pending were resolved.
Frequently asked questions
Is there a settlement in the PPI litigation?
A master settlement agreement is recorded in Case Management Order No. 109, entered October 2, 2023. The order states that the AstraZeneca and Merck defendants entered it without admission of fault or liability. It does not state the terms, and the documents reviewed contain no final approval order.
Does the label warn that PPIs cause kidney disease?
The omeprazole label warns about acute tubulointerstitial nephritis, a different condition from the chronic kidney disease described in the study that preceded the litigation. It has no warning section for chronic kidney disease. A warning is a regulatory action, not a causation finding.
Is MDL No. 2789 a class action?
No. It consolidates individual federal actions for pretrial proceedings before one judge, which centralizes discovery and pretrial motions without merging the claims or deciding their merits. See MDLs compared with class actions.
What does the pending count mean?
The Panel counts actions still open on the docket: 11,404 pending of 18,755 filed as of October 1, 2026. The figure does not describe how the other actions ended or indicate the strength of any claim.
Who oversees the litigation?
Judge Claire C. Cecchi, with Magistrate Judge Leda Dunn Wettre, in the District of New Jersey, under master docket 2:17-md-02789.
Background appears in the pharmaceutical lawsuits hub, alongside the Elmiron vision injury litigation, the Depo-Provera meningioma litigation and the insulin pricing litigation.
Sources
- U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by District, Report Date 10/1/2026” (link, accessed 2026-10-18)
- U.S. District Court for the District of New Jersey: “Proton-Pump MDL 2789” (link, accessed 2026-10-18)
- U.S. District Court for the District of New Jersey: “Initial Case Management Order, In re: Proton-Pump Inhibitor Products Liability Litigation, MDL No. 2789 (D.N.J. August 23, 2017)” (link, accessed 2026-10-18)
- U.S. District Court for the District of New Jersey: “Case Management Order No. 100, In re: Proton-Pump Inhibitor Products Liability Litigation, No. 2:17-md-02789 (D.N.J. June 15, 2023)” (link, accessed 2026-10-18)
- U.S. District Court for the District of New Jersey: “Case Management Order No. 109 (Docket Control Order), In re: Proton-Pump Inhibitor Products Liability Litigation, No. 2:17-md-02789 (D.N.J. October 2, 2023)” (link, accessed 2026-10-18)
- National Library of Medicine, DailyMed: “PRILOSEC (omeprazole magnesium) delayed-release granules, prescribing information (revised March 2024)” (link, accessed 2026-10-18)
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