Retinopathy of Prematurity: Historical Evolution of Clinical Management and Medico-Legal Evaluation in Japan

The management of retinopathy of prematurity (ROP) has evolved alongside advances in neonatal medicine, shaped by both scientific progress and medico-legal influences. ROP-related medical malpractice lawsuits provide a unique perspective on how standards of care are defined and evaluated. This review comprises two complementary components: a narrative medico-historical review of ROP management and a structured descriptive comparison of judicial cases identified in publicly accessible legal databases in Japan. The aim was to clarify how evolving clinical practice, dissemination of knowledge, and institutional capacity have influenced judicial interpretations of the standard of care. The findings indicate that standards of care in ROP management have been determined not solely by established evidence but by a broader assessment of contemporaneous professional knowledge and clinical practice. A marked shift in judicial outcomes after the mid-1970s corresponded to the widespread adoption of systematic screening and photocoagulation therapy. These results suggest that medico-legal evaluation reflects system-level maturity in neonatal care. In the current era of anti-vascular endothelial growth factor therapy, litigation is likely to focus less on specific interventions and more on the appropriateness of clinical decision-making, consideration of alternatives, and adequacy of informed consent procedures. This review provides a medico-historical framework for improving patient safety, risk management, and quality of care in neonatal practice.