Research On Law Systems Of Medical Product Liability

Medical products significantly relate to the public's health and their safety of life and property. In recent years, reports about the adverse reaction of the group resulted from medical products can be constantly seen in the newspapers; meanwhile, quality problems caused by medical appliances and medical products are emerging in endlessly. Therefore, it is necessary to do this research.The whole thesis consists of six chapters. Chapter one begins with the preview on the development of product liability system, in which liability principle in product responsibility is discussed. Then, by starting from the denotative meaning of medical products, it is discussed and concluded that medical products are covered in the products stipulated in Product Liability Law. Chapter two suggests that strict liability should be applied to the medical product after introducing the liability principle of product responsibility in our country. It also accounts for the constitutive elements of medical product responsibility and exemption from liability for medical product responsibility. Chapter two also introduces the defects of medical products which are considered to be divided into design defect, manufacturing defect and warning defect. In the part about design defect, it analyzes the adverse reaction system of medical products, and discusses the Compensatory Mechanism of the adverse reaction of medical products, the After-sale Monitoring Mechanism of the defect product and the Mechanism of Defect Medical Product Recall, which have been established abroad. In the part about warning defects, it discusses that theory of negligence equals to strict liability in function in respect of liability principle in warning defects, and also analyzes the timely, continuous, adequate after-sale warning services including that the warning objects for the medical product manufacturers can be divided into"learned intermediary"----medical institutions (refers to RX and medical appliance) and consumers (refers to OTC). Chapter three introduces that, regarding to bear liability, the responsible objects for medical products in our country include medical institutions, those who produce or sell or store or deliver medical products, those who put their names, trademarks or other distinguishing features on the products( so-called half-producers), and other objects. Chapter four analyzes the sharing relations among the responsible objects. The author holds that the relation between the producer (including half-producer) and the seller is unreal joint responsibility. Chapter five suggest that the medical institution and the administrative organ should bear the supplementary responsibility in the medical product liability. And the after-sale warning system of the defect product and the defect medical product recall system should be established in our country according to international practice,while the punitive indemnity system should not be established.Finally, it is concluded in this thesis that the conception"unqualified products"should be changed by"defect product", the claim order of the mechanism and the recourse mechanism among the responsible objects should be established in our country. The final responsible objects should bear the responsibility finally, and the medical institutions and the administrative organ should bear the supplementary responsibility in the medical product liability.