《侵权法重述第三次产品责任编》文档格式.docx

1、产品：（a）如果背离其设计意图，即便在该产品准备和营销过程中已尽到所有可能的注意，那么（产品）包含制造缺陷;（b）如果可预见的因该产品引起的损害风险能够通过销售者或以其他方式分发者，或者他们在分销商业链中的前手，通过采纳合理替代性设计而减少或者避免，而没有采纳合理替代性设计致使产品不具有合理性安全，那么（产品）设计存在缺陷;（c）如果可预见的因该产品引起的损害风险能够通过销售者或以其他方式分发者，或者他们在分销商业链中的前手，通过提供合理的说明或警示而减少或者避免，而没有提供合理的说明或警示致使产品不具有合理性安全，那么（产品）因说明或警示不足而存在缺陷。产品缺陷的分类及其各自的归责原则 重述

2、三将产品缺陷明确地分为三类:制造缺陷、设计缺陷和警示缺陷,并根据缺陷类型的不同设定各自的责任分配方式。对于制造缺陷,即使生产者和销售者尽到了一切注意义务,仍要为其产品致人损害承担责任。而对于因设计缺陷和警示缺陷,则需要达到该产品含有“不合理的危险”的标准,并且原告有义务提供合理的替代, 否则被告将不承担责任。这是重述三中最为引人注目的规定。划分了这三种缺陷,对于制造缺陷仍然采严格责任标准,无论生产者在生产过程中采用了怎样的质量监控手段,对于自己的生产线上出产的不合格产品致人损害依然要承担严格责任;对于后两者,则由原告负担“合理替代”的设计或警示的举证义务,确立了一种“合理性”的标准。（原因）对

3、于制造缺陷的产品, 厂商在生产的时候就能够预期到会有一定数量的不合格产品出现, 这样的制造不合格产品所带来的危害由通常对此毫无预见无法保护自己的消费者来承担是不公平的。而设计缺陷则不同,一个合理设计的产品依然可能是有危险的,消费者享受了该产品带来的效用,却要求生产者无条件地承担几乎是必然会产生的所有风险对后者是不公平的。除了平衡消费者和生产者的权利之外,这一发展也有利于实现消费者之间的利益平衡:在严格责任下,粗心的使用产品产生的危害可以得到赔偿,而这些赔偿其实已经通过保险转嫁到所有的消费者头上,当那些谨慎的消费者购买那些附加了保险费的昂贵产品时,就是在为另一些人的不小心付钱。现在的安排就不会让

4、那些小心使用产品的人为粗心的消费者掏腰包了。2 Categories of Product DefectA product is defective when, at the time of sale or distribution, it contains a manufacturing defect, is defective in design, or is defective because of inadequate instructions or warnings. A product: （a） contains a manufacturing defect when the pr

5、oduct departs from its intended design even though all possible care was exercised in the preparation and marketing of the product;（b） is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design

6、by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe;（c） is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product cou

7、ld have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe.3.支持推断产品缺陷的间接证据当损害原告的事件满足下列特征

8、，即使没有关于具体缺陷的证据，也可以推定原告所遭受的损害是由在产品在销售或者分发时存在的产品缺陷导致的：（a）该事件属于通常是由产品缺陷引起的类型;并且（b）在该具体案件中，不是仅仅由于产品在销售或者分发时存在的缺陷以外的原因引起的。3 Circumstantial Evidence Supporting Inference of Product DefectIt may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale

9、 or distribution, without proof of a specific defect, when the incident that harmed the plaintiff:（a） was of a kind that ordinarily occurs as a result of product defect; and（b） was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or dist

10、ribution. 4.对产品安全法律或法规的违反与遵守4 Noncompliance and Compliance with Product Safety Statutes or Regulations有关设计缺陷责任或者说明或警示不充分责任：（a）产品对可适用的产品安全法律或法规的违反，致使产品存在与该法律或法规旨在减小的风险有关的缺陷;（b）产品对可适用的产品安全法律或法规的遵守，在决定该产品是否存在与该法律或法规旨在减小的风险有关的缺陷时应该予以适当考虑，但这种遵守并不排除作为法律问题对产品缺陷的认定。In connection with liability for defective

11、 design or inadequate instructions or warnings:（a） a product,s noncompliance with an applicable product safety statute or administrative regulation renders the product defective with respect to the risks sought to be reduced by the statute or regulation;（b） a product,s compliance with an applicable

12、product safety statute or administrative regulation is properly considered in determining whether the product is defective with respect to the risks sought to be reduced by the statute or regulation, but such compliance does not preclude as a matter of law a finding of product defect.主题2适用于特殊产品或产品市场

13、的责任规则Topic 2- Liability Rules Applicable to Special Products or Product Markets5.产品零件商业销售者或分销者对装配了该零件的产品导致损害的责任从事产品零件销售或者以其他方式分发的经营者，销售或分销产品零件，应对对装配了该零件的产品导致的人身或财产损害承担责任，如果：（a）该零件自身存在本章所定义的缺陷，并且该缺陷导致了该损害;或（b）（1）该零件的销售者或分销者实质上参与了将该零件装配入该产品设计;（2）该零件的装配导致该产品存在本章所定义的缺陷;并且 （3）产品的该项缺陷造成了该损害。5 Liability of

14、 Commercial Seller or Distributor of Product Components for Harm Caused by Products Into Which Components Are IntegratedOne engaged in the business of selling or otherwise distributing product components who sells or distributes a component is subject to liability for harm to persons or property cau

15、sed by a product into which the component is integrated if:（a） the component is defective in itself, as defined in this Chapter, and the defect causes the harm; or（b）（1） the seller or distributor of the component substantially participates in the integration of the component into the design of the p

16、roduct;（2） the integration of the component causes the product to be defective, as defined in this Chapter;（3） the defect in the product causes the harm.6.商业销售者或分销者对缺陷处方药和医疗设备导致损害的责任（a）处方药或医疗设备的制造商销售或者以其他方式分发有缺陷的处方药或医疗设备，应对该缺陷对人身造成的伤害承担责任。处方药或医疗设备是指必须依据卫生保健提供者的处方才能合法地销售或者以其他方式分发的药品或设备。 2（b）为第a款规定的责任

17、目的，如果在销售或以其他方式分销时处方药或医疗设备符合下列情形之一的，存在缺陷：（1）包含第2条第a款所定义的制造缺陷;（2）由于本条第c款所定义的设计缺陷而不具有合理的安全性;（3）由于本条第d款所定义的说明或警示不充分而不具有合理的安全性。（c）如果某种药品或医疗设备引起的可预见的损害风险与其可预见的治疗效果相比十分巨大 3，以致理性的卫生保健提供者在知道可预见的风险和治疗效果的情况下，都不会给任何一类患者开具该药品或医疗设备的处方，那么该处方药或医疗设备由于设计缺陷而不具有合理的安全性 （d）如果关于可预见的损害风险的合理说明或者警示未能提供给以下对象，那么处方药或医疗设备由于说明或警示

18、不充分而不具有合理的安全性：（1）处于依据说明或警示降低损害风险环节 4的开具处方或者其他卫生保健提供者;（2）在处方药或医疗设备制造者知道或有理由知道的卫生保健提供者不会处于依据说明或警示降低损害风险环节情况下的病人。（e）处方药或医疗设备的零售商或其他分发者应对该药品或设备所致的损害承担责任，如果：（1）该药品或医疗设备在销售或以其他方式分销时包含第2款第a款所定义的制造缺陷;（2）该药品或医疗设备在销售或以其他方式分销时或在此之前，零售商或其他分发者未尽合理注意，并因此导致了人身伤害。6 Liability of Commercial Seller or Distributor for

19、Harm Caused by Defective Prescription Drugs and Medical Devices（a） A manufacturer of a prescription drug or medical device who sells or otherwise distributes a defective drug or medical device is subject to liability for harm to persons caused by the defect. A prescription drug or medical device is

20、one that may be legally sold or otherwise distributed only pursuant to a health-care provider,s prescription.（b） For purposes of liability under Subsection （a）, a prescription drug or medical device is defective if at the time of sale or other distribution the drug or medical device:（1） contains a m

21、anufacturing defect as defined in 2（a）;（2） is not reasonably safe due to defective design as defined in Subsection （c）;（3） is not reasonably safe due to inadequate instructions or warnings as defined in Subsection （d）.（c） A prescription drug or medical device is not reasonably safe due to defective

22、design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for

23、 any class of patients. （d） A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:（1） prescribing and other health-care providers who are in a position to

24、reduce the risks of harm in accordance with the instructions or warnings;（2） the patient when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.（e） A retail seller or other dis

25、tributor of a prescription drug or medical device is subject to liability for harm caused by the drug or device if:（1） at the time of sale or other distribution the drug or medical device contains a manufacturing defect as defined in 2（a）;（2） at or before the time of sale or other distribution of th

26、e drug or medical device the retail seller or other distributor fails to exercise reasonable care and such failure causes harm to persons.7.商业销售者或分销者对缺陷食品导致损害的责任从事食品销售或者分销经营活动者，销售或者以其他方式分发存在第2、3、4规定的缺陷的食品，应对该缺陷所造成的人身或财产损害承担责任。根据第2条第a款的规定，如果一个合理的消费者不能预见该食品中含有此种成分，则食品中的该致害成分构成缺陷。7 Liability of Commerc

27、ial Seller or Distributor for Harm Caused by Defective Food ProductsOne engaged in the business of selling or otherwise distributing food products who sells or distributes a food product that is defective under 2, 3, or 4 is subject to liability for harm to persons or property caused by the defect.

28、Under 2（a）, a harm-causing ingredient of the food product constitutes a defect if a reasonable consumer would not expect the food product to contain that ingredient. 8.商业销售者或分销者对存在缺陷的旧货导致损害的责任从事旧货销售或者以其他方式分发的经营者，销售或分发有缺陷的旧货，应对该缺陷所造成的人身或财产损害承担责任，如果该缺陷：（a）源于销售者未尽合理注意;（b）是第2条第a款所规定的制造缺陷，或第3条规定的可以推断出的缺陷

29、，并且销售者的产品营销会使处于与购买者相同环节的理性人期望该旧货不会比该产品全新时具有更大的风险;或者（c）是第2条和第3条规定的经过销售者或商业分发链条中的前手重制 5的旧货;（d）源于根据第4条的规定，旧货违反了适用于旧货的产品安全法律或法规。旧货是指在本条中提到的销售或者以其他方式分发之前，被商业性地出售或者以其他方式分发给商业分发链条以外的购买者并被使用了一段时间的产品。8 Liability of Commercial Seller or Distributor of Defective Used ProductsOne engaged in the business of selling or otherwise distributing used products who sells or distributes a defective used product is subject to liability for harm to persons or property caused by the defect if the defect:（a） arises from the seller,s failure to exercise reasonable care;（b） is a m