医疗产品责任纠纷实证研究——基于195份判决书的分析

An empirical study of the medical product liability disputes——Based on the analysis of 195 judgments

目的:分析研究195份医疗产品责任纠纷案例存在的问题,希望对医疗产品责任纠纷的解决、医患关系的改善有所裨益。方法:对北大法宝法律数据库以“医疗产品责任纠纷”为案由进行检索,得到2011-2021年共195份判决书,通过实证分析法,以图表形式统计分析案件的各项特点。结果:48.84%的案件上诉率提示了部分案件对责任承担存在分歧;60.21%的医疗器械产品责任比例说明医疗器械管理体系存在不足;62.56%的鉴定比则反映了因果关系认定过于依赖医学鉴定的问题;141份案例的诉讼主体为医疗机构,而仅有8份案件涉及医疗机构向最终责任人追偿,反映出医疗机构追偿权难以实现的问题。结论:医疗产品责任纠纷系医疗纠纷中的关键问题,建议明确不同主体的举证责任分配及其归责原则、构建医疗产品质量管理体系,完善医学鉴定机制与医疗产品责任法律规范体系,推进医疗纠纷解决途径多元化。

Objective:By analyzing the problems in 195 judgments of"medical product liability dispute",expecting to be helpful to the resolution of medical product liability disputes and the promotion of the harmony between doctors and patients.Methods:Based on the case of"medical product liability dispute",the Chinalawinfo Database of Peking University was searched,and 195 judgments were statistically analyzed in the form of chart through empirical analysis.Results:The appeal rate of 48.84%indicates the divergence of responsibility;60.21%of the medical device product responsibility shows that the medical device management system is inadequate;62.56%of the appraisal ratio reflects the problem that the over dependence of causality on medical identification;the litigation subjects of 141 cases are medical institutions,while only 8 cases involve medical institutions to recover from the ultimate responsible person,which reflects the problem that the recovery right of medical institutions is difficult to realize.Conclusion:Medical product liability disputes are the key issues in medical disputes.The authors suggested that the clear distribution of different subjects’responsibilities,construction of medical product quality management system,the improvement of medical appraisal mechanism and the legal norm system of medical product liability from the perspective of medical law,and the promotion of the diversification of the ways of the resolution of medical dispute.