Civil liability of laboratories for erroneous results

Abstract

This study aims to analyze the legal complexity surrounding the civil liability of clinical laboratories in cases involving erroneous test results. An observational, cross-sectional, and descriptive methodology was employed, with data collected from the public databases of the Courts of Justice of São Paulo and Rio Grande do Sul, without time restrictions, in search of judicial decisions related to laboratory liability for errors in tests. A total of 33 relevant rulings were selected. The analysis revealed a higher incidence of claims related to HIV and gestational syphilis testing, with decisions predominantly favoring consumers, particularly in cases involving moral damages. The literature review highlighted the absence of a clear legal structure governing laboratory liability, despite the extensive scientific literature addressing the technical limitations of diagnostic tests. Civil liability was found not to arise solely from the erroneous result but from the breach of technical and scientific duties, underscoring the need for a thorough assessment of both causality and laboratory conduct. The analyzed case law tends to treat the obligation of laboratories as one of result, although judicial decisions may relativize liability considering the beneficial effects of early diagnosis. The study concludes that the civil liability of laboratories is predominantly objective and contractual, requiring proof of wrongful conduct, causal nexus, and damage for the claim of compensation, contributing to the improvement of legal understanding and protection of patients’ rights.