叶正明

【摘 要】 在美国产品严格责任制度中，药品具有缺陷是药品侵权责任成立的前提条件。在涉及药品责任的诉讼中，对药品缺陷的证明是决定诉讼胜败的关键。“美国第三次侵权法重述”把药品缺陷分为设计缺陷、制造缺陷、使用说明或警示缺陷。 其各自不同的判断标准，既能帮助原告理解抽象的缺陷概念，也为原告通过具体的证据去证明缺陷指明了方向。探讨美国药品缺陷判断与证明的法律理论以及判例经验，以期能对我国相关法律的建设与司法实践提供一些有益的参考。

【关键词】 药品责任；药品缺陷；证明

【中图分类号】 D915.13

【文献标识码】 A

【文章编号】 1674-1226（2011）03-0338-07

Proof of Drug defects in Drug Liability Litigation of USA. Ye Zhengming. Hunan insititute of technology,Hengyang 421002, Hunan, China

【Abstract】 Drug with defects is a precondition for the establishment of drug tort liability in the United States where a strict product liability system is adopted. In a drug liability litigation, the drug being proved to have defects is essential to determine whether the action wins or not. According to the Third Restatement of Torts, drug defects are divided into manufacturing defect, design defect, usage instruction or warning defect, and their respective judgment standard not only helps the plaintiff to comprehend the abstract concept of the defect ,but also directs the plaintiff to prove defects by concrete evidences. This paper aims, by studying the American judgment and proof of drug defect, to provide some help for China to construct its relevant law and set up its judicial practice.

【Key Words】 Drug Liability, Drug defects, Proof