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Special article Evidence integration on health damage for humidifier disinfectant exposure and legal presumption of causation
Mina Ha1orcid , Taehyun Park2orcid , Jong-Hyeon Lee3orcid , Younghee Kim4orcid , Jungyun Lim4orcid , Yong-Wook Baek4orcid , Sol Yu4orcid , Hyun Mi Chung4orcid , Kyu Hyuck Chung5orcid , Hae-Kwan Cheong6orcid
Epidemiol Health 2023;e2023095
DOI: https://doi.org/10.4178/epih.e2023095 [Accepted]
Published online: October 24, 2023
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1College of Medicine, Dankook University, Cheonan, Korea
2Law School of Kangwon National University, Chunchun, Korea
3EH R&C Co., Incheon, Korea
4Environmental Health Research Department, National Institute of Environmental Research, Incheon, Korea
5School of Pharmacy, Sungkyunkwan University, Suwon, Korea
6School of Medicine, Sungkyunkwan University, Suwon, Korea
Corresponding author:  Kyu Hyuck Chung,
Email: hkcheong75@gmail.com
Hae-Kwan Cheong,
Email: hkcheong75@gmail.com
Received: 28 February 2023   • Revised: 12 August 2023   • Accepted: 4 September 2023
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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 a line of evidence comprising hazard information, animal studies, and mechanistic studies. The confidence levels for evidence-based toxicological effects and source-to-outcome pathways are synthesized to classify 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 toxicological studies. It is not simply as statistical correlation 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.

Epidemiol Health : Epidemiology and Health
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