提问
第一章基于销售时产品缺陷的商业产品销售者责任
Chapter 1- Liability of Commercial Product Sellers Based on Product Defects at Time of Sale
主题1普遍适用于产品的责任规则
Topic 1- Liability Rules Applicable to Products Generally
§1.商业销售者或者分发者因缺陷产品导致损害的责任
从事产品销售或者以其他方式分发 [1]的经营者，销售或者分发缺陷产品，应对该缺陷所造成的人身或者财产损害承担责任。
1 Liability of Commercial Seller or Distributor for Harm Caused by Defective Products
One engaged in the business of selling or otherwise distributing products who sells or distributes a defective product is subject to liability for harm to persons or property caused by the defect.
§2.产品缺陷的种类
产品在销售或者分发时，包含制造缺陷，设计存在缺陷，或者因为说明或警示不充分而存在缺陷，则该产品存在缺陷。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。
2 Categories of Product Defect
A 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 product 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 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 could 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，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 Defect
It may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale 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 distribution.
§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;并且
(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 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; and
(b) a product,s compliance with an applicable 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的责任规则
Topic 2- Liability Rules Applicable to Special Products or Product Markets
§5.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;并且
(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 Commercial Seller or Distributor of Product Components for Harm Caused by Products Into Which Components Are Integrated
One 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 caused 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 product; and
(2) the integration of the component causes the product to be defective, as defined in this Chapter; and
(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;或
(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;或
(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;或
(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;或
(2)该药品或医疗设备
