The Study Of Drug Defect Liability

Drugs belong to product though they have their own peculiarities. Drug defect liability applies no-fault principle, and the constitutive requirements of it are defect, damage and causality. Based on the law of our country and referring to the legislation, theories and cases of foreign countries, the article aims to put forward constructive suggestions on our judicial practice of drug defect liability, by discussing about how to ascertain and prove drug defect, how to prove causality and the scope of liability subject.The article is divided into four parts.Part Ⅰ is about the definition of drug defect. In this part, we will know that drug defect refers to unreasonable danger of drugs, and it essentially involves security issues. Due to the fact that drug standards are not security standards, drug standards could not guarantee the security of drugs. Therefore, qualified drugs may also be ascertained a defect.Part Ⅱ is about the ascertaining and proving of the defect of drugs. In this part, we will discuss three questions. The No.1 is about the ascertaining of the defect of drugs. In its specific ascertaining, we should apply different criteria according to the differences of prescribed drug and over-the-counter drugs and also apply different criteria for design, manufacturing and instruction defect. The No.2 question is about if ADR could be ascertained a defect. It is because ADR is based on the concept of qualified drugs, and qualified drugs can also has a defect, there is room for discussing the question. And we will focus on the situations where ADR will be ascertained a defect. In the No.3 question, we will elaborate the principle of res ipsa loquitur.Part Ⅲ is about the causality between defect and damage. The proving of causality applies probability causality principle and epidemiology causality principle. When applying probability causality principle, we sometimes should use some auxiliary methods, such as market share theory and expert witness system. Furthermore, in this part, we will also analysis the provision of article 5 from supreme people court on the application of law of trying food and drug cases.Part Ⅳ is about the subject of drug defect liability. In this part, the meaningful discussing is about the defining for the scope of the producers and the responsibilities of Medical institutions. In order to protect the interest of victims, raw materials producers and associate producers should be delimited producers, we will also discussing the legal status ofMedical institution in the drug defect liability, namely, whether there is imputation basis of article 59 of tort law.