Keytruda Organ Failure

No MDL exists for Keytruda organ failure claims as of August 2026; litigation proceeds as decentralized individual product liability actions in state and federal courts against Merck Sharp & Dohme LLC. Plaintiffs allege failure to warn that pembrolizumab's PD-1 inhibition causes severe immune-mediated organ failure, including myocarditis, cardiomyopathy, acute kidney injury, pneumonitis, colitis, and hepatitis. Merck halted 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.

No MDL exists for Keytruda organ failure claims as of August 2026. Litigation remains decentralized with individual product liability actions proceeding in state and federal courts against Merck Sharp & Dohme LLC. FDA label revisions in November 2025 expanded immune-mediated adverse reaction warnings to 'any organ system or tissue' with fatality risk.

Approximately 2,799 patients in pooled FDA safety database with 19% discontinuation rate in largest NSCLC monotherapy cohort; FDA label revisions November 2025 and January 2024 expand immune-mediated adverse reaction warnings to 'any organ system or tissue' with fatality risk. No MDL or centralized litigation docket identified as of March 2026; state-specific SOL windows apply for individual claims.

• Arkansas

  Wrongful death lawsuit filed Sept. 24, 2025, in Arkansas state court alleging fatal acute cardiomyopathy, acute kidney injury, and myocarditis from Keytruda; strict products liability and failure to warn claims pending. Source: LegalClarity (June 2026)

• New Jersey

  Wrongful death lawsuit pending in state court alleging fatal acute cardiomyopathy, acute kidney injury, and myocarditis from Keytruda; strict products liability and failure to warn claims. Source: LegalClarity (June 2026)

• California

  Two-year SOL from date of injury discovery applies for individual immune-mediated adverse reaction claims; attorneys evaluating claims from patients who developed myocarditis, cardiomyopathy, or acute kidney injury after Keytruda treatment. Source: LegalClarity (June 2026)

• Nationwide — 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 documented across approximately 2,799 patients in FDA pooled safety database. Source: FDA Label 125514s188 (Nov. 2025)

• Nationwide — Allogeneic HSCT Treatment Centers

  Transplant centers: 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 125514s18, Section 5.3

• Nationwide — KEYNOTE-042 Clinical Trial Sites

  Multisite Stage III/metastatic NSCLC monotherapy cohort: 19% discontinuation rate; serious adverse reactions including pneumonitis (3.0%), pneumonia (1.4%), death of any cause (1.6%). Source: FDA Label 125514s188 (Nov. 2025); Merck HCP safety data (2025)