Research On Legal Liability Of Adverse Drug Reactions

Drug therapy is the most important means of clinical treatment.But because of the" two sides" of a drug,Adverse Drug Reactions(ADR)often occur after drugs is used.Especially the serious ADR can cause serious consequences to patients.In a series of events of ADR,such as "ling Lanxin","Vioxx","Longdanxiegan Pills","lipobay",the right of life and health of the victims in these events is greatly aggrieved. While the great majority of victims did not receive compensation and relief,because Tort Liability for ADR in our country is diseased.Not only the victims themselves were harmed physically and spiritually,but also the victim's family has also been hard hit.The major study methods applied by this paper are methods of literature research, cases study,induction and illation and so on.The paper systemically explores the liability of ADR,by analyzing the criterion of liability,the elements of liability,compensation of ADR,by the point of designing defects of drugs.The paper sums up the problems occurred when judicial departments handle ADR dispute,and makes suggestions and designs about liability of ADR in China.The paper uses the theory of production defects,opens out that the nature of ADR is designing defects of drugs.The paper analyzes the three the elements of liability of ADR,compares the two identification criterion on products defects in the field of products liability:consumer expectation and risk- utility,and determine risk- utility is the criterion for judging drug design defects.The paper uses the theory of risk- utility criterion,and puts forward a "two-steps" idiographic identification method of drug designing defects.The paper analyzes the specificity of the causality between designing defects of drugs and damage in ADR events,and puts forward five idiographic identification method of causality between designing defects of drugs and damage,according to the five theories about identification method of causality in the field of products liability. The paper provides a reference to judging the liability subject.This paper analyzes the problems occurred when judicial departments handle ADR dispute,such as the criterion of liability,identification,proof responsibility assignment,these problems tell against the victims.And make the following legislative suggestions to deal with these issues and improve relevant laws and regulations:enact special＜Regulations on Handling Adverse Drug Reactions Accident＞,using＜Regulations on Handling Medical Accidents＞;adopt the principle of strict liability; improve the identification system,establish the Committee on identifying ADR; Improve the system of proof responsibility assignment,adopt inverse proof responsibility assignment.This paper is composed of six parts:(1)The definition of ADR and legal liability; (2)The nature of ADR and the criterion of liability;(3)The elements of liability;(4)The compensation for victims in the adverse drug reactions events;(5)The problems which are against the victims when judicial departments handle ADR disputes in our country;(6)The legislative suggestions are presented To deal with these issues and improve relevant laws and regulations.In this paper,the object of this research is defined by illuminating the conception of ADR and legal liability in Part one.Part two opens out that drug design defects is the nature of ADR,and the principle of strict liability is determined as the criterion of liability of ADR.Part three analyzes the three elements of of the adverse drug reactions liability under the principle of strict liability, and presents idiographic identification methods to provide a reference for judging the liability subject.Part four probes into means of compensation and grounds for exemption.Part five summarizes the actuality the problems in the system of ADR liability.Part six presents legislative suggestions.