论美国药品缺陷责任对我国的启示

Drug Defect Liability in America and Its Enlightment for China

目的:为我国药品缺陷责任的认定和适用情况提供建议。方法:以美国产品责任法中药品缺陷责任的系统规定为借鉴,为我国处理药品缺陷损害案件时的归责原则及适用情况提出建议。结果与结论:关于产品缺陷的种类,美国法院习惯上分为设计缺陷、制造缺陷和警示缺陷三类,消费者预期标准和风险-效益标准是美国法院判断产品缺陷最为常用的两种方法,为此设立了一系列针对药品责任的特殊规则。借鉴美国法上的一些先进经验,在药品设计缺陷案件中,我国对"不合理危险"的判定应采风险-效益认定方法;药品的制造缺陷责任应适用严格责任;药品的设计缺陷责任和警示缺陷责任应适用过失责任。未来的产品责任立法应在缺陷分类方面有所进展。

OBJECTIVE： To provide suggestions for the identification and application of drug defect liability in China. METH- ODS： Referring to systematic legislations about drug defect liability in America, the suggestions about the principles of liability fix- ation of drug defect liability and its application were pointed out in China. RESULTS ＆ CONCLUSIONS： The types of product de- fect are used to divide into design defect, manufacturing defect and warning defect by courts of America; customer excepted stan- dard and risk-benefit criterion are 2 commonly used methods; special regulations for drug liability have been established. Referring to advanced experience of America, risk-benefit criterion should be applied to judge ＂unreasonable danger＂ in drug design defect case. For the liability caused by drug manufacturing defect, it is necessary to apply strict liability criterion. For the liability caused by drug design defect and warning defect, it is necessary to apply negligence liability criterion. Some improvements of product lia- bility legislation are required in the filed of defect classification.