药品设计是不同的

在一篇题为《〈侵权行为法重述(第三次):产品责任〉中有设计缺陷吗?》论文中,George Conk批评美国法律协会和新重述的报告人免除处方药制造者设计缺陷责任。本文是新重述的报告人对他和其他批评者的一个回应。本文第一部分概述Conk的论文,包括他对新重述的解释。第二部分指出Conk批评中的重大错误:他误读了重述,而且他对血液案例的依靠是错位的。第三部分解释新重述对处方药品设计的处理和它对产品设计缺陷的一般处理之间的实质性的差别并使之正当化。这些差别包括新重述拒绝允许法院去考虑尚未得到FDA许可的可替代的更安全的处方产品(在一般设计条款下,法院通常是考虑尚未上市的替代性设计的)和拒绝牺牲一类患者的福利去增进另一类患者的福利(在一般设计条款下,这种消费者之间的相互利益牺牲通常是得到宽容的。第三部分也解释为什么药品设计诉讼不能通过减少其复杂性而合法地被变得更有利于原告,以及为什么新重述的规定不会明显地降低制造者发现新的、更加安全的处方产品的积极性。

In an essay entitled Is There a Design Defect in the Restatement(Third)of Torts:Products Liability"1.,George Conk criticizes the American Law Institute and the Reporters of the new Restatement for immunizing prescription drug manufacturers from liability for defective design.This Paper offers a response both to him and to other critics.Part I of this Essay summarizes Conk’s thesis,including his interpretation of the new Restatement.PartⅡidentifies significant errors in Conk’s critique:He has read the Restatement incorrectly,and his reliance on the blood cases is misplaced.PartⅢexplains and justifies the substantive differences between the new Restatement’s treatment of prescription drug design and its treatment of defective product design generally.These differences include the Restatement’s refusal to allow courts to consider alternative,safer prescription products that have not yet received FDA approval(under the general design provisions,courts routinely consider not-yet-marketed alternative designs)and its refusal to sacrifices the welfare of one class of patients to enhance the welfare of another class of patients(under the general design provisions,such cross-consumer sacrifices of welfare are routinely condoned).PartⅢalso explains why drug design litigation cannot legitimately be made more plaintiff-friendly by reducing its complexity and why the rule in the new Restatement should not significantly reduce manufacturers’incentives to discover new and safer prescription products.