医疗产品损害责任归责原则及相关问题刍议.pdfVIP

中国卫生事业管理却12 年第3 期(总第 285 期) [卫生法制} 医疗产品损害责任归责原则及相关问题鱼议* 向敌1 ，刘蔚1 ，方强2 (1.泸州医学院，四川泸州 6460∞;2. 四川省泸州市江阳区人民法院) [摘要] 医疗产品损睿责任的性质与一般的产品责任相似，医疗机构的地位也相当于一敛销售者，其归责原则也 应采用元过错责任房、则。对医疗产品缺陷的认定应从设计制造缺陷扩大到警示、跟踪观察缺陷。医疗产品损害责任应 实行举证责任缓和，并对缺陷与损害的因果关系实行不完全推定。《侵权责任法》需要在明确生产者与医疗机构的内部 责任、明确销售者的责任主体地位等方面作出改进，另外，可借鉴美国的制度进一步完善医疗产品安全监测和报告制度。 [关键词] 医疗产品损害责任;侵权责任法;元过错责任Jt. JI~ ;举证责任缓和;因果关系 [中图分类号] D 923 [文献标识码) A [文章编号] 1 ∞4-4663(2012)03 -199 -03 Discussioo 00 Liability principle for damages attributable to medical products and related issues. /XIANG X凹，et al. / /The Chin岱eH国Ith Service Managemeot也 Abstract The nature of damage liahility of medical products is similar ωthat of general products ,the p咽ition of medical institutions is 呻且ivalent to general selIers ,and its damage liahility principle should also apply the principle of no-fault liahility. 四e identification of defectives of medical products should be extended from desi伊 and manufacturing defects to waming and tracking the defects. Medical products liahility for damage should be implemented to e也e the burden of proof ,and the incomplete presumption should be adopted for the causal relationship betw四n defects and damage. Tort Liahility Act飞hould be improved in are幽，such as ,making clear the intemal responsibility of the manufacturer and the medical institutions ,ststing clearly the respon- sibility of the sellers ,etc. In addition ,learn from the United States to further improve the medical product safety monitoring and re- portmg system. Authors ad由·慰自s Luzhou Medical College ,Luzhou ,P. R. China. Key word damage liahility of medical products;Tort Liahility Act;principle of no-fault liahility;ease the burden of proof;