植入类医疗器械侵权责任形态研究
发布时间：2018-11-04 20:55
【摘要】：在现代化医疗领域,植入类医疗器械被大规模使用,该类器械一旦存在缺陷,将不可避免的对人身体健康造成侵害。但是在法律实务中,当下实体法仅将医疗产品侵权以不真正连带责任加以规制,并未对植入类医疗器械侵权予以明确规定,难以有效满足各方利益诉求。以植入类医疗器械致害作为研究对象,从医疗机构的责任承担为出发点,以致害原因为标准,将植入类医疗器械致害划分为单纯医疗器械缺陷致害、单纯使用过失致害以及非单纯性致害三类,并就其责任形态、使用规则等问题进行明晰。其次,就植入类医疗器械侵权责任构成要件进行系统分析,在缺陷认定上,就其过度依赖强制性标准的情况和警示缺陷的不同予以说明;在损害方面,将机会丧失侵权损害纳入损害赔偿范围,而且就实践中的相关损害认定做法予以评析;在因果关系上,就因果关系构成、举证、以及认定方面的特殊性进行了详细阐述,并就医疗鉴定在因果关系认定上的作用作出评述。最后,探讨植入类医疗器械工艺水平抗辩、博学的中间人抗辩、受害人同意三种特殊抗辩事由,就其适用的合理性予以说明,以期达到利益平衡,各责任主体更加公平合理的分配责任。
[Abstract]:In the modern medical field, implantable medical devices are used on a large scale. Once there are defects in these devices, they will inevitably cause harm to human health. However, in the legal practice, the current substantive law only regulates the infringement of medical products with unreal joint and several liability, and does not clearly stipulate the tort of implanted medical devices, so it is difficult to effectively meet the interests of all parties. Taking implantable medical devices as the research object, taking the responsibility of medical institutions as the starting point and the cause of medical devices as the standard, the harm of implantable medical devices is divided into simple medical device defects. There are only three types of damage caused by negligence and non-simple damage, and the responsibility form and usage rules are clarified. Secondly, the author makes a systematic analysis on the constitutive requirements of tort liability for implantable medical devices, and explains the situation of excessive reliance on mandatory standards and the difference of warning defects in the identification of defects. In the aspect of damage, the loss of opportunity tort damage should be included in the scope of damage compensation, and the practice of identifying the damage in practice should be evaluated. In the aspect of causality, the particularity of causality constitution, proof and cognizance is expounded in detail, and the function of medical appraisal in causation identification is commented. Finally, the author discusses the technological level defense of implantable medical device, the erudite middleman defense, the victim agrees to three special defense reasons, and explains the rationality of its application, in order to achieve the balance of interests. Each responsibility main body distributes the responsibility more fairly and reasonably.
【学位授予单位】：烟台大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D923
本文编号：2311109
[Abstract]:In the modern medical field, implantable medical devices are used on a large scale. Once there are defects in these devices, they will inevitably cause harm to human health. However, in the legal practice, the current substantive law only regulates the infringement of medical products with unreal joint and several liability, and does not clearly stipulate the tort of implanted medical devices, so it is difficult to effectively meet the interests of all parties. Taking implantable medical devices as the research object, taking the responsibility of medical institutions as the starting point and the cause of medical devices as the standard, the harm of implantable medical devices is divided into simple medical device defects. There are only three types of damage caused by negligence and non-simple damage, and the responsibility form and usage rules are clarified. Secondly, the author makes a systematic analysis on the constitutive requirements of tort liability for implantable medical devices, and explains the situation of excessive reliance on mandatory standards and the difference of warning defects in the identification of defects. In the aspect of damage, the loss of opportunity tort damage should be included in the scope of damage compensation, and the practice of identifying the damage in practice should be evaluated. In the aspect of causality, the particularity of causality constitution, proof and cognizance is expounded in detail, and the function of medical appraisal in causation identification is commented. Finally, the author discusses the technological level defense of implantable medical device, the erudite middleman defense, the victim agrees to three special defense reasons, and explains the rationality of its application, in order to achieve the balance of interests. Each responsibility main body distributes the responsibility more fairly and reasonably.
【学位授予单位】：烟台大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D923
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