Empirical research on medical damage liability of off-label drug use： based on judicial cases
10.12026/j.issn.1001-8565.2025.11.08
- VernacularTitle:超说明书用药医疗损害责任实证研究
- Author:
Ping WANG
1
;
Zenghui HUO
1
;
Jing ZHANG
1
Author Information
1. School of Humanities， Beijing University of Chinese Medicine， Beijing 102488， China
- Publication Type:Journal Article
- Keywords:
off-label drug use;
medical damage liability;
medical ethics review;
empirical research
- From:
Chinese Medical Ethics
2025;38(11):1431-1440
- CountryChina
- Language:Chinese
-
Abstract:
The use of off-label drugs， which accompanies the approval system for new drugs entering the market， is widespread in clinical practice in China， and the resulting medical damage liability is also controversial in theory and practice. Based on 129 judicial cases from 2014 to 2023， this paper conducted a quantitative analysis of medical damage liability caused by off-label drug use. Through sorting out， it was found that the cases of off-label drug use presented obvious characteristics in types and regional distribution， and their damage consequences and appeal rates were far higher than those of general medical damage cases， which need to attract more attention. Based on the liability reasons， this paper further categorized the cases into three types： no liability， single liability， and multiple liabilities. The number and liability ratio of off-label drug use under different liability types were analyzed， and the key factors affecting the establishment of medical damage liability for off-label drug use were sorted out and analyzed in depth. These key factors included the existence of off-label drug use and a clear causal relationship between off-label drug use and medical damage， inadequate informed consent， and lack of sufficient and solid evidence-based medical support. Additionally， it was confirmed that a medical ethics review is not a prerequisite for the legality of off-label drug use. Finally， recommendations for off-label drug use in clinical practice were proposed， such as ensuring timeliness， adequacy， and formality of informed consent， adhering to a clear causal relationship construction， as well as sorting out the scope and effectiveness level of evidence-based medicine to establish industry self-consistency.
