论文部分内容阅读
美国法律协会产品责任法第三次重述采用了“更安全的可选择设计”标准来判断产品的责任缺陷。即如果产品本来可以被设计得更加安全,而制造商却没有做到,产品就会被认定具有设计缺陷,制造商就要为此而承担责任。但是,重述对药品、疫苗和医疗设备却采取另一套判断标准,即只要它们对至少一类用户有益无害,制造者就可以被免除责任。重述还将血液制品完全排除出了产品责任法的管辖范围。二十余年来,由于没有对血液制品实行严格的产品责任,致使血液制品制造商没有及时发展出血液灭菌技术,导致大量血友病患者染上肝炎和艾滋病。这一悲剧性的事件说明,应当对药品、疫苗和医疗设备和其他产品一样适用同样的产品缺陷检验标准。因此,对重述应当加以修改:对可以进行更安全设计的产品实施“可选择的更安全的设计”标准,对无法合理地应用这一标准的其他产品应实行一般的成本收益分析标准。这种对传统的过失法的回归可以构成一种更为一致的判断设计缺陷的方法。
The third iteration of the American Law Association's Product Liability Law adopts the “safer alternative design” criterion to determine product liability deficiencies. That is, if the product could have been designed to be more secure, and the manufacturer failed to do so, the product would be identified as having a design flaw and the manufacturer would have to take responsibility for that. However, there is a restatement of another set of judgments on medicines, vaccines and medical devices that manufacturers can be exempted from as long as they are beneficial to at least one type of user. Restatement also completely exclude blood products from the jurisdiction of the product liability law. For more than two decades, the absence of strict product liability for blood products has caused blood product manufacturers to fail to develop blood sterilization technologies in a timely manner, resulting in a large number of hemophiliacs contracting hepatitis and AIDS. This tragic incident shows that the same product defect inspection standards should apply to medicines, vaccines and medical devices and other products. Therefore, the restatement should be amended to include a “safer alternative design” for products that can be safer to design, and to apply common cost-benefit analysis criteria for other products that do not apply the standard reasonably . This return to traditional negligence can form a more consistent method of determining design flaws.