Justifcation Of Civil Liability Of Adverse Drug Reaction And Construction Of It's Relief System

Since “Long-dan-xie-gan Pill” event occurred,events of adverse drug reactions(hereinafter referred to as ADR)causing damage often appears in newspapers.Damage caused by those ADRs has the following characteristics: influence for a long time,wide impact range,a large number of victims.Therefore,it is of utmost urgency to define Relief group harm by ADR and to help those people efficient and timely.But seriousness exposed from characteristics of ADR never draws public attention.On one hand,it is perhaps because that the preparation of the relief system requires more resources or more proper timing to set up the whole system;on the other hand,legal system of China(mainly refers to the system of civil liability)has a natural defect in the remedy of ADR.A glimpse into the medical practice of our country,either that define drugs with ADR as fake ones to punish the drugmakers from administration,or that absolutely negate “the defect” of ADR,tolerate “unreasonable risks” of drug to close the remedy of ADR to the victims from the judiciary.In addition,there is no local transplant of the international drug adverse reaction damage relief fund system.And the liability insurance system for adverse drug reactions is only tested in a small scale,which there is no overall market benefit.So,the social relief mechanism for adverse drug reactions has not yet been formed.Thus it can be seen that Judicial and social relief rarely help victims of adverse drug reactions.In order to ensure that the victims of ADR can receive timely protection in the window period of relief system.This paper attempts to construct a remedy system for ADR based on the interpretation of the law.and starting from the product liability,we seek the compatible region of drug adverse reactions in product liability,so as to help thevictims of adverse drug reactions to obtain realistic and feasible relief channels.Through the interpretation of logic,This paper integrates the principles of sociology and economics(social benefits and efficiency)and reconsiders the traditional operation mode of product defects.The traditional method of identification of product defects summarized “dual rules” according to article 46 of Product Quality Law,which is preferred way to applicable national or trade standards identified defects.and in practice,it is usually simplified as the only national or industrial standards as the only basis,no longer considering product whether there is“unreasonable danger”.This simplification does not conform to the definition of product defects and is different from the international order of applicable standards.Given that the country or industry standard of the drug is not "standard" because of its hysteresis,and the legal provisions and judicial interpretations are not the only criteria for determining the drug state or industry standard according to the results of the comparison in articles of law.Therefore,in the identification of drug defects,“unreasonable danger” should be established as the ultimate standard.From the perspective of comparative law,the American product defect standard is refined into the principle of "risk-benefit" and "consumer expectation" which are actually on the investigation to the tolerance,combined with the severity of ADR and the degree of social influence factors,adverse drug reactions can be identified as "unreasonable danger",even be called a drug defects.The generation of product liability for drug defects also needs to overcome the interference of the defense,and the most powerful defense is the "development risk defense" with immunity function.Through the analysis,it can be seen that the original intention of "development risk defense" is not in harmony with the spirit of The Times.There is a doubt of legitimacy that "Development risk defense" is applicable to of strict liability,and foreign legal practice often needs to restrict the application of "development risk defense".Therefore,it can be used as an argument tool to break through liability exemption of "development risk defense".In order to establish the liability system of adverse drug reaction products,it is necessary to distinguish which adverse reactions can be regulated by the system.According to the medical and legal practice experience,common property,predictable and which drug benefit is much higher than the adverse reactions caused by the risk,can be eliminated the adverse drug reaction type relief category of product liability system to reduce the adverse drug reactions to judge for the defect of work.Then,asthe ultimate principle of discriminating defects,"unreasonable danger" still should be refined into several operational standards,to which "risk-benefit" principle and "Consumer expectations" of The United States law of has great meaning.In the specific case,in order to effectively protect the interests of the victim,adverse drug reaction on the proof of causation should be on the premise of medical proof method,adopt "probability" theory and the theory of "disease study causality".The application of "market share" theory may be considered when the defendant is unable to be confirmed in the lawsuit of liability for adverse drug reactions.And the burden of proof is more advantageous to protect the plaintiff status of the victim.