药品安全事件中侵权责任因果关系探讨

Discussion on causation of drug tort liability in drug safety incidents

目的:减轻受害者举证责任,保护其合法权益。方法:采用文献研究、理论研究和案例分析方法,探讨导致药品安全事件中侵权责任因果关系证明及认定困难的原因及相关解决方法。结果:证明药品侵权责任因果关系是十分困难的,无论是受害者举证亦或是法院依申请或依职权委托专业部门鉴定,都不能完全查明。实践中,应为降低证明难度寻求有效途径。结论:因相关立法机关对药品安全事件中侵权责任因果关系的认定方式未有统一规定,导致各地法院对同一类型的案件作出不同的审理结果。以必然因果关系结合高度盖然性规则作为药品安全事件中侵权责任因果关系的认定理论,在统一标准出台之前,有利于降低受害者对因果关系的证明难度。

Objective：To reduce the burden of proof and then protect the legal rights of victims.Method：The reasons and solutions of proof and recognition of causation in drug safety incidents is explored based on the literature and theory research and case studies.Result：It extremely diffi cult to prove the causation of drug tort liability,because it cannot be ascertained no matter the victims provide evidences or the court entrust professional departments to identify by application or by authority.In practice,we should search effective ways to lighten the proof diffi culty.Conclusion：The legislature has no uniform provision for the identifi cation methods of causation in drug safety incidents,which leads to the different trial verdicts in each local court against the same case.Combining necessary causality with high probability rule as the recognized standards in drug safety incidents is favorable to decrease the proof diffi culties of causation for the victims.