Evidence integration on health damage for humidifier disinfectant exposure and legal presumption of causation
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OBJECTIVES: Inhalation exposure to humidifier disinfectants has resulted to various types of health damages in Korea. To determine the epidemiological correlation necessary for presuming the legal causation, we aimed to develop a method to synthesize the entire evidence. METHODS: Epidemiological and toxicological studies are systematically reviewed. Target health problems are selected by criteria such as frequent complaints of claimants. Relevant epidemiologic studies are reviewed and the risk of bias and confidence level of the total evidence are evaluated. Toxicological literature reviews are conducted on three lines of evidence including hazard information, animal studies, and mechanistic studies, considering the source-to-exposure-to-outcome continuum. The confidence level of the body of evidence is then translated into the toxicological evidence levels for the causality between humidifier disinfectant exposure and health effects. Finally, the levels of epidemiological and toxicological evidence are synthesized. RESULTS: Under the Special Act revised in 2020, if the history of exposure and the disease occurred/worsened after exposure were approved, and the epidemiological correlation between the exposure and disease was verified, the legal causation is presumed unless the company proves the evidence against it. The epidemiological correlation can be verified through epidemiological investigations, health monitoring, cohort investigations and/or toxicological studies. It is not simply as statistical association as understood in judicial precedents, but a general causation established by the evidence as a whole, i.e., through weight-of-the-evidence approach. CONCLUSIONS: The weight-of-the-evidence approach differs from the conclusive single study approach and this systematic evidence integration can be used in presumption of causation.
Abstract
OBJECTIVES: Inhalation exposure to humidifier disinfectants has resulted to various types of health damages in Korea. To determine the epidemiological correlation necessary for presuming the legal causation, we aimed to develop a method to synthesize the entire evidence. METHODS: Epidemiological and toxicological studies are systematically reviewed. Target health problems are selected by criteria such as frequent complaints of claimants. Relevant epidemiologic studies are reviewed and the risk of bias and confidence level of the total evidence are evaluated. Toxicological literature reviews are conducted on three lines of evidence including hazard information, animal studies, and mechanistic studies, considering the source-to-exposure-to-outcome continuum. The confidence level of the body of evidence is then translated into the toxicological evidence levels for the causality between humidifier disinfectant exposure and health effects. Finally, the levels of epidemiological and toxicological evidence are synthesized. RESULTS: Under the Special Act revised in 2020, if the history of exposure and the disease occurred/worsened after exposure were approved, and the epidemiological correlation between the exposure and disease was verified, the legal causation is presumed unless the company proves the evidence against it. The epidemiological correlation can be verified through epidemiological investigations, health monitoring, cohort investigations and/or toxicological studies. It is not simply as statistical association as understood in judicial precedents, but a general causation established by the evidence as a whole, i.e., through weight-of-the-evidence approach. CONCLUSIONS: The weight-of-the-evidence approach differs from the conclusive single study approach and this systematic evidence integration can be used in presumption of causation.
참고문헌 (37)
- Committee on the Investigation of Humidifier Disinfectant Lung Injury, "White paper on humidifier disinfectant induced health hazards: from recognition of the outbreak to the establishment of the diagnostic criteria", pp.37~67 (2014), Ministry of Health and Welfare
- Ha M, "Introduction to environmental health policy", pp.491~505 (2022), Dankook University Press
- "Special Act on Remedy for Damage Caused by Humidifier Disinfectants"[URL]
- "Enforcement Decree of the Special Act on Remedy for Damage Caused by Humidifier Disinfectants"[URL]
- "NIER report of review on epidemiological correlations between humidifier disinfectants exposure and health effects" (2022)[URL]
- "Handbook for conducting a literature-based health assessment using OHAT approach for systematic review and evidence integration" (2019)[URL]
- Guyatt GH, "GRADE guidelines : 4. Rating the quality of evidence--study limitations(risk of bias)", J Clin Epidemiol, 64, pp.407~415 (2011)
- Adami HO, "Toxicology and epidemiology : improving the science with a framework for combining toxicological and epidemiological evidence to establish causal inference", Toxicol Sci, 122, pp.223~234 (2011)
- Whaley P, "Biological plausibility in environmental health systematic reviews : a GRADE concept paper", Environ Int, 162, pp.107109~ (2022)
- Price PS, "Organizing mechanism-related information on chemical interactions using a framework based on the aggregate exposure and adverse outcome pathways", Environ Int, 138, pp.105673~ (2020)
- Bian Q, "A new method to evaluate toxicological data reliability in risk assessments", Toxicol Lett, 311, pp.125~132 (2019)
- Tan YM, "Aggregate exposure pathways in support of risk assessment", Curr Opin Toxicol, 9, pp.8~13 (2018)
- Collier ZA, "A weight of evidence assessment approach for adverse outcome pathways", Regul Toxicol Pharmacol, 75, pp.46~57 (2016)
- Organization for Economic Cooperation and Development (OECD), "Users’ handbook supplement to the guidance document for developing and assessing adverse outcome pathways" (2018)
- "Supreme Court Decision 72Da1774 Decide December 10, 1974"[URL]
- "Supreme Court Decision 2006Da17539 Decide July 12, 2013"[URL]
- Hill AB, "The environment and disease: association or causation?", Proc R Soc Med, 58, pp.295~300 (1965)
- "Reference manual on scientific evidence"[URL]
- 이연갑, "역학연구결과에 의한 인과관계의 증명", 법조, 61(7), pp.110~150 (2012), 법조협회[DOI]
- "Supreme Court Decision 2011Da22092 Decide April 10, 2014"[URL]
- "Seoul High Court Decision 2002Na32662 Decide January 26, 2006"[URL]
- "Partial amendment review report for Special Act on Remedy for Damage Caused by Humidifier Disinfectants" (2020)[URL]
- "Minutes of the 376th legislation and judiciary committee meeting: partial amendment for Special Act on Remedy for Damage Caused by Humidifier Disinfectants" (2020)[URL]
- 박태현, "환경오염으로 인한 건강피해소송에서 역학연구를 통한 인과관계의 입증 - 판례법리를 중심으로 -", 법학논총, 38(3), pp.173~199 (2014), 법학연구소[DOI]
- "Supreme Court Decision 2008Da16776 September 29, 2011"[URL]
- "Seoul Central District Court Decision 2019Gohap142, 388, 501 Decide January 12, 2021"[URL]
- McGarity TO, "Daubert and the proper role for the courts in health, safety, and environmental regulation", Am J Public Health, 95(Suppl 1), pp.S92~S98 (2005)
- Krimsky S, "The weight of scientific evidence in policy and law", Am J Public Health, 95(Suppl 1), pp.S129~S136 (2005)
- EFSA Scientific Committee, "Guidance on the use of the weight of evidence approach in scientific assessments", EFSA J, 15, pp.e04971~ (2017)
- Celentano DD, "Gordis epidemiology", pp.293~295 (2018), Elsevier
- Korean Society of Preventive Medicine, "Preventive medicine and public health", pp.60~67 (2022), Gyechuk Munwhasa
- Fedak KM, "Applying the Bradford Hill criteria in the 21st century : how data integration has changed causal inference in molecular epidemiology", Emerg Themes Epidemiol, 12, pp.14~ (2015)
- Kim KW, "Humidifier disinfectant-associated children’s interstitial lung disease", Am J Respir Crit Care Med, 189, pp.48~56 (2014)
- Tossavainen A, "Asbestos, asbestosis, and cancer : the Helsinki criteria for diagnosis and attribution", Scand J Work Environ Health, 23, pp.311~316 (1997)
- Etzel RA, "Environmental epidemiology in a crossfire", Environ Health, 20, pp.91~ (2021)
- Sterne JA, "ROBINS-I : a tool for assessing risk of bias in non-randomised studies of interventions", BMJ, 355, pp.i4919~ (2016)
- Eick SM, "Assessing risk of bias in human environmental epidemiology studies using three tools : different conclusions from different tools", Syst Rev, 9, pp.1~13 (2020)