Revista medica de Chile · 2026
Civil Liability for Ocular Toxicity Caused by Perfluorocarbon Liquids: The MEROCTANE Case in Chile.
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San Martin Rocio, Mora Luis
Аннотация
UNLABELLED: Perfluorocarbon liquids (PFCL) are used in vitreoretinal surgery due to their favorable physicochemical properties. However, in 2013, cases of severe ocular toxicity were reported in Chile, associated with contaminated batches of perfluorooctane (PFO) marketed under the name MEROCTANE. These events exposed critical failures in quality control mechanisms and gave rise to multiple judicial rulings in the field of civil liability.
AIM: xTo analyze the biomedical and legal foundations of the MEROCTANE case in Chile from an interdisciplinary perspective, identifying the technical factors that caused the ocular damage, delineating civil liabilities, and describing the regulatory reforms that resulted from this event.
METHODS: A narrative review was conducted using biomedical and legal databases in Spanish, English, and Italian. The legal analysis employed both dogmatic and comparative methods between Chile and Italy.
RESULTS: This event resulted in fourteen cases of acute ocular toxicity in Chile, most of them leading to irreversible blindness. Chemical analyses (GC-MS) identified batch-dependent toxic impurities (OCT.01.2013), and cytotoxicity assays showed cell viability below 10%. These findings revealed purification failures, absence of batch-specific controls, and deficiencies in certification processes. In response, ISO Standard 16672:2020 was developed, and the European framework was strengthened through Regulation (EU) 2017/745. In Chile, the Supreme Court established liability for lack of service in hospitals, health services, and the Public Health Institute (ISP), as well as civil liability of the treating physician for lack of due diligence and of the distributor for marketing defective products. Subsequently, Law No. 20.850 introduced strict liability for defective health products and for development risks.
CONCLUSIONS: The MEROCTANE case exposed serious deficiencies in the manufacturing, certification, and surveillance of medical devices, as well as limitations of the subjective liability regime then in force. The subsequent reforms underscore the need for batch-by-batch controls, effective traceability, and more stringent regulatory standards. This case constitutes a significant precedent for global health law, highlighting the preventive role of civil liability in addressing industrial risks that compromise patient safety.
AIM: xTo analyze the biomedical and legal foundations of the MEROCTANE case in Chile from an interdisciplinary perspective, identifying the technical factors that caused the ocular damage, delineating civil liabilities, and describing the regulatory reforms that resulted from this event.
METHODS: A narrative review was conducted using biomedical and legal databases in Spanish, English, and Italian. The legal analysis employed both dogmatic and comparative methods between Chile and Italy.
RESULTS: This event resulted in fourteen cases of acute ocular toxicity in Chile, most of them leading to irreversible blindness. Chemical analyses (GC-MS) identified batch-dependent toxic impurities (OCT.01.2013), and cytotoxicity assays showed cell viability below 10%. These findings revealed purification failures, absence of batch-specific controls, and deficiencies in certification processes. In response, ISO Standard 16672:2020 was developed, and the European framework was strengthened through Regulation (EU) 2017/745. In Chile, the Supreme Court established liability for lack of service in hospitals, health services, and the Public Health Institute (ISP), as well as civil liability of the treating physician for lack of due diligence and of the distributor for marketing defective products. Subsequently, Law No. 20.850 introduced strict liability for defective health products and for development risks.
CONCLUSIONS: The MEROCTANE case exposed serious deficiencies in the manufacturing, certification, and surveillance of medical devices, as well as limitations of the subjective liability regime then in force. The subsequent reforms underscore the need for batch-by-batch controls, effective traceability, and more stringent regulatory standards. This case constitutes a significant precedent for global health law, highlighting the preventive role of civil liability in addressing industrial risks that compromise patient safety.