医疗产品缺陷的侵权责任归责原则研究  

Study on Tort Liability Responsibility Principle of Medical Product Defects

作　　者：卢军锋[1] 邵振[2] 

机构地区：[1]江苏畜牧兽医职业技术学院,江苏泰州225300 [2]太仓市中医医院,江苏太仓215400

出　　处：《中国药房》2013年第33期3078-3080,共3页China Pharmacy

摘　　要：目的:为《侵权责任法》实施以后如何合理适用因医疗产品缺陷引发的医疗诉讼中涉及的归责原则提供参考。方法:以法理学研究方法为基础,对司法实践中涉及的过错责任原则、过错推定原则、严格责任原则、公平责任原则、综合责任原则等5种归责原则进行辩证探析,探讨医疗产品缺陷侵权适用的归责原则。结果与结论:不同的归责原则适用于不同案情。如果医疗产品的缺陷由医疗机构及其医务人员操作使用不当造成患者人身损害的,则适用过错责任原则和过错推定原则;如果医疗产品的缺陷由产品的生产者、销售者造成的应当适用严格责任原则;但如果生产者、销售者有合理的抗辩理由,则适用公平责任原则更为合理;如果医疗产品的缺陷有产品生产者、销售者的过错,同时医疗机构及其医务人员也未合理履行谨慎义务而使医疗产品造成患者人身损害的,应当首先适用严格责任原则,其次适用过错责任原则;综合责任原则意指其他4种归责原则的综合运用,包含不同的原则,需要在具体情况下加以辨证适用。OBJECTIVE： To provide reference for rational use of responsibility principle involved in medical litigation caused by medical product defect after the implementation of Tort Liability Act. METHODS： Based on jurisprudence research methods, 5 kinds of responsibility principles involved in the judicial practice were analyzed with dialectical method, i.e. the principle of fault li- ability, the principle of fault presumption, the principle of strict liability, the principle of equitable liability, the principle of gener- al liability, to explore suitable responsibility principle of medical product defect. RESULTS ＆ CONCLUSIONS： The different re- sponsibility principles are suitable for different cases. If medical product defects are caused by the improper use of medical product by medical institutions and medical staff which result in physical injury of patients, and then the principle of fault liability and the principle of fault presumption is suitable; in the case of the medical product defects are caused by product producers and sellers to result in physical injury of patients, and then the principle of strict liability is suitable for medical products producers and sellers; if the producers and sellers provide reasonable grounds of opposition, the principle of equitable responsibility is more suitable; medi- cal product defects is the fault of the producers and sellers, at the same time, medical institutions and m^dical personnel do not ful- fill a duty of care so as to result in physical injury of patients, and then the principle of strict liability should be first applied, fol- lowed by the principle of fault liability; the principle of general liability means integrated use of other 4 responsibility principles and contains different principles, which should be used with dialectical method in specific cases.

关 键 词：医疗产品 缺陷 侵权责任 归责原则 法理学 

分 类 号：R95[医药卫生—药学]