Litigation of unlicensed US stem cell products

Branden Lee; Noah Brookes; Adam S Levin

doi:10.1016/j.stem.2025.04.001

Litigation of unlicensed US stem cell products

Cell Stem Cell. 2025 May 1;32(5):684-688. doi: 10.1016/j.stem.2025.04.001.

Authors

Branden Lee¹, Noah Brookes², Adam S Levin³

Affiliations

¹ Johns Hopkins University School of Medicine, 733 N Broadway, Baltimore, MD 21205, USA; Department of Orthopaedic Surgery, The Johns Hopkins Hospital, 601 N. Caroline Street, Suite 5251, Baltimore, MD 21287, USA.
² Johns Hopkins University School of Medicine, 733 N Broadway, Baltimore, MD 21205, USA.
³ Department of Orthopaedic Surgery, The Johns Hopkins Hospital, 601 N. Caroline Street, Suite 5251, Baltimore, MD 21287, USA. Electronic address: alevin25@jhmi.edu.

PMID: 40315833
DOI: 10.1016/j.stem.2025.04.001

Abstract

Financial dispositions against unapproved stem cell interventions have grown significantly, with successful class-action lawsuits, malpractice claims, and collaborative prosecutions between government agencies. In addition to improved dispositions, federal circuit courts have given unanimous affirmation to the FDA's regulatory authority over stem cell interventions, establishing critical precedents for oversight.

MeSH terms

Humans
Malpractice / legislation & jurisprudence
Stem Cell Transplantation* / legislation & jurisprudence
Stem Cells* / cytology
United States
United States Food and Drug Administration / legislation & jurisprudence