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Monitoring76 eventsPharmaceutical

Keytruda Organ Failure

Pharmaceutical · claims concerning immune-checkpoint inhibitor injuries, including organ failure or severe immune events

Defendant

Merck Sharp & Dohme LLC

MDL / Track

See litigation status

Judge

Various

Plaintiffs

MONITORING

Bellwether / Trial

No verdicts

Settlement Status

No mass settlement

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← Torts Case overview Litigation status Geographic exposure Key defendants Timeline Statute of limitations Live activity News PubMed openFDA Court filings

Case overview

Plaintiffs allege Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab) causes severe immune-mediated organ failure, including acute kidney injury, liver failure, pneumonitis, and colitis, through inadequate warnings. Litigation remains decentralized with no MDL established as of March 2026; cases proceed as individual product liability actions in state and federal courts. Merck halted two Phase 3 trials (KEYNOTE-867 and KEYNOTE-630) in August 2024 after interim analysis showed no survival benefit and higher rates of adverse events including death.

Causation Theory

Keytruda's mechanism—blocking PD-1 to enhance T-cell anti-tumor activity—induces immune-related adverse events by disrupting self-tolerance. A pooled analysis of 8,937 patients across 31 trials (Brahmer et al., Eur J Cancer 2024) found Grade 3–5 adverse events in 50.6% of patients, with immune-mediated events affecting any organ system; 5.9% of patients died from treatment-related causes. A September 2024 Emory University study of metastatic lung cancer patients (TriNetX Research Network) found PD-1 inhibitors like Keytruda carried a 20% pulmonary embolism rate versus 14% for PD-L1 inhibitors. The FDA's Oncologic Drugs Advisory Committee called for restrictions on PD-1 inhibitors in September 2024, citing moderate survival benefits against high toxicity risks.

Geographic exposure

Approximately 2,799 patients in pooled safety database (FDA label); 19% discontinuation rate in largest NSCLC monotherapy cohort. No MDL or centralized litigation docket identified as of March 2026; state-specific SOL windows apply for individual immune-mediated adverse reaction claims.

United States — Nationwide
FDA label revisions November 2025 and January 2024 expand immune-mediated adverse reaction warnings to 'any organ system or tissue' with fatality risk; 19% discontinuation rate in KEYNOTE-042 NSCLC monotherapy trial due to adverse reactions including pneumonitis (3.0%), pneumonia (1.4%), and death of unknown cause (1.6%). Source: FDA Label 125514s188 (Nov. 2025), 125514s147 (Jan. 2024)
Clinical Trial Sites — KEYNOTE-042
NSCLC first-line monotherapy sites: 1,251 previously untreated Stage III/metastatic patients; permanent discontinuation 19% (121/636), serious adverse reactions in ≥2% included pneumonitis, pneumonia, and death. Source: Merck Keytruda HCP safety data (2025)
Clinical Trial Sites — KEYNOTE-051
Pediatric oncology sites: 173 pediatric patients aged 6 months to <18 years with cHL, PMBCL, or solid tumors; immune-mediated adverse reactions observed in pediatric population. Source: FDA Label 125514s188
Allogeneic HSCT Treatment Centers
Transplant centers nationwide: FDA warning for fatal and serious complications in patients receiving allogeneic hematopoietic stem cell transplantation before or after PD-1 blockade; GVHD and hyperacute graft-versus-host disease documented. Source: FDA Label 125514s188 Section 5.3
Oncology Infusion Centers — Community and Academic
IV pembrolizumab administration sites: 30-minute infusion protocol; immune-mediated pneumonitis (3.4% in pooled trials) and infusion-related reactions require monitoring. Source: FDA Label 125514s188; Mayo Clinic Drug Information (2026)

Key defendants

Merck Sharp & Dohme LLC

Role: Manufacturer

FDA label (Rev. 11/2025) acknowledges immune-mediated adverse reactions 'may be severe or fatal' and 'can occur in any organ system or tissue.' No MDL currently active; Dunn Sheehan LLP advertising Keytruda organ failure litigation with reported confidential settlements in related pharmaceutical cases. Patent litigation with Halozyme Therapeutics ongoing in D.N.J. over subcutaneous formulation (filed April 2024).

Defendant	Role	Intelligence Note
Merck Sharp & Dohme LLC	Manufacturer	FDA label (Rev. 11/2025) acknowledges immune-mediated adverse reactions 'may be severe or fatal' and 'can occur in any organ system or tissue.' No MDL currently active; Dunn Sheehan LLP advertising Keytruda organ failure litigation with reported confidential settlements in related pharmaceutical cases. Patent litigation with Halozyme Therapeutics ongoing in D.N.J. over subcutaneous formulation (filed April 2024).

Timeline

2014-09
FDA Approves Keytruda
FDA grants accelerated approval to pembrolizumab (Keytruda) for advanced melanoma, marking first PD-1 inhibitor approval. Label includes warnings for immune-mediated adverse reactions affecting any organ system.
2017-01
Merck Settles Patent Litigation
Merck enters $625 million settlement and license agreement with Bristol-Myers Squibb and Ono Pharmaceutical, resolving worldwide patent litigation over anti-PD-1 antibodies. Agreement includes royalty payments through 2026.
2024-01
FDA Updates Keytruda Label
FDA approves label revision adding new indications and updated warnings for immune-mediated adverse reactions. Revision date: January 2024.
2024-08
Merck Halts Two Phase 3 Trials
Merck discontinues KEYNOTE-867 (lung cancer) and KEYNOTE-630 (cutaneous squamous cell carcinoma) trials after interim analysis shows no survival benefit and increased risks of immune-mediated adverse events including pneumonitis, colitis, hepatitis, and death.
2025-07
FDA Removes Hepatocellular Carcinoma Indication
FDA removes accelerated approval indication for hepatocellular carcinoma following confirmatory trial failure. Label updated July 2025.
2025-11
FDA Approves Expanded Mesothelioma Indication
FDA approves Keytruda in combination with chemotherapy for malignant pleural mesothelioma. Label revision includes updated immune-mediated adverse reaction warnings.

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LexGenius Ranking

40Score

Fresh items are present but not yet surging

Evidence20 / 20

Momentum20 / 20

Exposure8 / 20

Regulatory8 / 20

Legal6 / 20

Monitoring

Live

monitoring

Last: Jun 13, 2026, 9:00 AM UTC

Next: 10:01

Source Monitoring

PACER

3s

PACER

Pending

Google News

1s

FAERS

10m 01s

PubMed

10m 01s

Event feed

76

events detected

Google NewsFAERSPubMed

AI Brief

Keytruda Organ Failure remains monitoring with 76 current signals in the accepted feed.

Overview

No active MDL or coordinated federal litigation exists for Keytruda organ failure claims as of March 2026. The search results contain no verified federal product liability dockets, JPML transfer orders, or MDL petitions for this specific theory. FDA label revisions through November 2025 continue to carry warnings for immune-mediated adverse reactions affecting multiple organ systems.

Key developments

Endpoints News news on Jun 12: FDA approves Merck's Welireg-Keytruda combo as adjuvant treatment for kidney cancer - Endpoints News. ‖ FAERS FDA alert on Mar 31: FAERS Filing 26561602: Neutropenia. ‖ PubMed research on Jun 12: Salvage tacrolimus therapy for steroid-refractory immune-related adverse event-associated sclerosing cholangitis..

Generated Jun 13, 2026, 9:00 AM UTC

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