真正的检验标准:专利垄断市场中对药品和医疗设备采用的“可选择的更安全设计”

美国法律协会(ALI)报告人James Henderson教授和AaronTwerski教授反对产品责任法重述第6条C款中针对处方药和医疗设备的产品设计缺陷采用普通的检验标准(重述第2条B款规定的'合理的可选择的设计检验标准')。美国法律协会阐述了对这些医疗设备应采用保护制造商的标准的原则,并宣称制造商仅在'罕见'的情况下才承担产品责任。根据重述第6条C款的规定,某一产品仅在不能为任何可预见的患者带来净收益时,该产品才有缺陷。Conk教授在之前的一篇文章中对该原则提出了异议。Nebraska州最高法院针对这一问题否决了重述中的这项原则。本文讨论了有关设计缺陷证据特点,Nebraska州法院指出将在以后对该问题进行解释。在一篇回应文章中,两位报告人现已接受对药品采用'可选择的更安全的设计'标准,但该检验标准仅限于将涉案产品同同一时间内书面上有的经由美国食品和药品管理局(FDA)批准的产品进行比较。两报告人提出的宽松的、带有挽救性质的解释是受人欢迎的。但Conk教授发现报告人的新提议尽管向前迈出了一小步,但是没有给出令人信服的解释。报告人坚持认为法院没有审理和裁判药品的产品设计缺陷诉讼的资格,因为法院必须尊重FDA复杂的审批程序才能对原告提出的可选择的更安全的设计作出裁决。因此,药品的产品设计缺陷的证明责任比所有其他类型的产品的责任更加严格,其他类型的产品既不需要提供原产品,也不需要市场上出现可选择的替代产品。这种新的更宽松的建议仍然不够充分。人们对专利垄断市场中存在的可选择的更安全的设计这一问题进行了讨论。Conk教授认为,在专利垄断市场中,原告承担的提供可选择的设计的责任应当比在开放的竞争市场中所承担的责任要轻。在比较开放的市场中,市场上没有更安全的产品会令原告就其所提出的可选择的设计的可行性和实用性承担更重的证明责任。本文讨论了根据重述第2条B款规定的'可选择的更安全的设计'的标准应承担的产品责任,而根据第6条C款规定的'保护制造商'的标准应免除责任的三个药品案例分析,即治疗痤疮的异构维生素A酸(Accutane)、未经巴氏杀菌消毒的抗血友病凝血因子(AHF)和萨宾(Sabin)口服弱活性小儿麻痹症疫苗(OPV)。最后,本文指出诸如IUD’s和止血垫这类医疗设备比药品更应当适用更安全的可选择的设计标准,同时还讨论了重述第6条C款的'最终的致命的缺陷',即药品和医疗设备适用的相同的保护制造商的产品责任标准。

In section 6(c)of the Products Liability Restatement,Profes-sors James Henderson and Aaron Twerski,the American Law Institute(ALI)reporters,rejected the ordinary test of product design defect(the section 2(b)reasonable alternative design test)for prescription drugs and medical devices.For such medical products the ALI rule enunciates a manufacturer-protective standard,declaring that under it liability would only"rarely"be imposed.A product is defective under section 6(c)only if it provides no net benefit for any foreseeable class of patients.The rule was challenged in an earlier article by Professor Conk.The first state supreme court to confront the issue,Nebraska’s,rejected the Restatement rule.This Article discusses the issue of the character of the proofs of design defect,which the Nebraska court indicated it will address in the future.In a rebuttal,the reporters now embrace an alternative safer design test for drugs.But they would limit the test to comparison with FDA-approved products actually available on the market at the time of sale of the challenged product.The reporters’broad,saving construction is welcomed.But Conk finds the reporters’new reading to be an unconvincing exegesis,if nonetheless a small step forward.The reporters assert that courts are incompetent to judge drug product design defect claims because they would have to replicate the complex FDA approval process in order to pass upon a plaintiff’s alternative safer design.This is a much greater burden than that for all other classes of products——or which no prototype need be produced,nor an alternative be shown to be on the market.The new broader construction is still inadequate.The problem of showing the existence of an alternative safer design in a patent-monopolized market is discussed.Conk argues that in patent-monopolized markets the burden on the plaintiff to produce an alternative design should be lighter than in robust markets open to competition.In more open markets the absence of a safer product on the market may carry greater evidentiary weight on the issues of the feasibility and practicality of the plaintiff’s proposed alternative design.Three case studies of drugs for which liability could be found under the alternative safer design test of section 2(b),but would be excused under the manufacturer-protective test of section 6(c),are discussed——the anti-acne drug Accutane,unpasteurized Anti-hemophilic Factor concentrate(AHF),and Sabin live virus oral polio vaccine.Finally,pointing to medical devices like IUD’s and tampons,and the fact that mechanical devices are more amenable to alternative safer design analysis than are drugs,the Article discusses the"final fatal flaw"of section 6(c)——its treatment of both drugs and devices by the same manufacturer-deferential standard of liability.