一个法律难题的诊断:美国药品缺陷的判断标准——美国第三次侵权法重述关于处方药缺陷之规定的评述与启示  

Diagnosis of a Legal Problem: Criteria on Medicine Defects in America——On the regulations of prescribed medicine defects in The Third American Tort Law

作　　者：叶正明[1] 

机构地区：[1]湖南工学院社科部,湖南衡阳421002

出　　处：《延边大学学报（社会科学版）》2011年第2期135-139,共5页Journal of Yanbian University：Social Science Edition

基　　金：国家社科基金项目(09CFX037)

摘　　要：药品在美国被认为是一种不可避免的不安全产品,有关其缺陷的概念及其判断标准与一般产品相比皆有其特殊性。美国第三次侵权法重述把药品缺陷分为制造缺陷、设计缺陷、使用说明或警示缺陷,并就其各自不同的判断标准做出了详细的评注,极大地方便了诉讼中的法律适用。我国目前药品侵权事件频发,而现有法律关于缺陷的规定值得商榷的地方仍然很多,造成了实践中药品缺陷认定的困惑,因此探讨美国在药品缺陷判断上的法律理论与判例经验,可以对我国相关制度的确立有所裨益。Medicine is considered as an inevitable unsafe product in America.The concept of medicine defects and the criteria related are different from those of ordinary commodities.The Third American Tort Law reinterprets medicine defects and divides them into defects in manufacturing,design,usage instruction and cautions.Different criteria are also commented in details.All of the above make the law application convenient in proceedings.The frequent incidents about infringing medicine at present show that laws and regulations concerning with medicine defects in China are imperfect so that it is hard to identify the defects in practice.The exploration of criteria on medicine defects identification and successful trials in America will be helpful for China to establish the relevant legal systems.

关 键 词：美国 药品缺陷 设计缺陷 制造缺陷 使用说明或警示缺陷 

分 类 号：D971.2[政治法律—法学] D912.1