The Tort Liability Of Defective Medical Device

Recently, with the national support being increasing continuously, the development of medical device industry in our country has been speeding up in the context of the process of globalization. The frequent use of medical apparatus in the field of medical treatment offers more choices for diagnosis and treatment of diseases, which has been to some extent the main reason for the increase of medical accidents. Defected medical devices tort disputes involve the property rights and right of health and life of patients as well as the legitimate rights and interests of medical institution and medical devices producers. However, the present medical devices management system is inadequate. Supervision and Regulation of Medical Devices, the only law and regulation standardizing medical devices management, cannot effectively regulate activities time and again in practice because of its low level. What's more, General Principles of the Civil Law, Product Liability law, The Law of Torts and other relevant standards of judgment are biased, inadequate in content, which consequently fail to fully protect the interests of victims involved in medical device violations. Therefore, aiming at regulating medical device industry better and protect the legitimate interests and rights of victims, it is of a great academic importance and operation value to do research on tortious liability in relation to defected medical devices.Firstly, the essay gave an introduction of current situation of medical device tortious liability in our country and made a detailed analysis about the loopholes and absence of legislation in relation to defected medical devices. Secondly, the essay discussed the basic problem that which medical device can cause violations, that is, the interpretation of"defected"medical devices. Then, the author discussed the criterion of tortious liability in relation to defected medical devices and causality cognizance; put forward the proper use of Principle of Liability without Fault and leading the theory of Market share Liability when doing causality cognizance. Finally, the author provided some opinions about concrete institutional laws in relation to medical device tortious liability.There are five chapters except abstract and conclusion in the essay, totally about 30 thousands words.Chapter 1 is mainly about the current situation of medical device market in our country and a detailed analysis about the loopholes and absence of legislation in relation to defected medical devices, including the 122nd Article in General Principles of the Civil Law, Articles from the 41st Article to the 47th Article as well as the 59th Article in Product Liability law and The Law of Torts, and the administrative rules and regulations such as Supervision and Regulation of Medical Devices and Management and Regulation of Medical Device Specifications Labels and Labels of the Package. Generally speaking, it is about the biased standard of defected medical device and the indefiniteness of proper use of Principle of Liability.Chapter 2 is mainly about the interpretation of"defected"medical devices. On the basis of employment of consumer's expectation standard, risk-benefit equilibrium analysis standard and cost-benefit analysis standard or bi-dividing method, the author draw her own conclusion that defected medical device should employ the theory of unreasonable risks.Chapter 3 is about the criterion of tortious liability in relation to defected medical devices. Proper use of Principle of Liability without Fault and leading the theory of Market share Liability when doing causality cognizance are put forward.Chapter 4 is about the subject of liability and coverage for liability in relation to defected medical device damage. There is no doubt that the producers and consumers of medical devices are the main subject of liability, however, the quality and orientation of medical institutions and the responsibility they should take play an important role. Meanwhile, responsibility of state regulations is what is easily neglected. The coverage for liability includes two parts like other product infringement: pecuniary damage compensation and mental damage compensation.Chapter 5 is about author's opinions about concrete institutional laws in relation to medical device tortious liability. For instance, establish recall and after-sales system in the field of defected medical devices; establish perfect medical devices liability insurance system; abide strictly by the system of Market Access, especially the entry into medical devices. The 59th Article in Tort Law is also discussed in this chapter.