缺陷醫藥品의 製造物責任에 관한 硏究

Abstract

According to the development of technology and highly industrialization various products have been produced, so our life become prosperous. But the more products become various, the more unexpected damages are increased. Therefore the legal principle that compensate consumer's damage due to defective product has developed. First of all to compensate damage caused from defective product, consumers had attempted the legal principle of contract law and tort law. However, each principle was insufficient for remedy of damage because of its limitations. After all to overcome the traditional theories, the legal principle of product liability has developed. The product liability is manufacturer's compensation for damages due to the lack of safety about products. It is to overcome the traditional principle of liability related to product. In these days many countries including Korea, the product liability has accepted through legislation. By the way, in the modern industrial society, medicine is a typical industrial goods through an economic structure of mass production and mass consumption. Ordinary medicine is comprised in the bounds of product. So the generalization of product liability applies in case of defective medicine directly. The defect is a requisite factor on the product liability for defective medicine, it means proper medicine is lacking of safety that is expecting ordinary. The defect is classified into manufacturing defect, design defect, warning defect, and the judgment of defects have to consider its type. The consumer of medicine or pertinent user can claim damages to not only general manufacturers, but also importers, in name only manufacturers, doctors and pharmacists. And suppliers are secondary to them. Though in some cases the liability can be justified in view of policy. When victims institute a lawsuit, they bear the burden of proof - existence of the defect, occurrence of damage, causal relationship. But it is very unfair to request the victim to prove the defect and cause. Because the manufacturers are more predominant position in technology and economy. So it is necessary to relieve the proof burden of the victims. In case of lawsuit to guarantee the effectiveness about remedy of damage, it needs to introduce a class suit and to have to submit essential documents. Also it is necessary to make full use of the alternative dispute resolution actively. In addition to medicine manufacturers insure for liability insurance compulsorily. Above all it is important to prevent the damage caused from defective medicine in advance. But that has realistic limitations. Therefore it needs to make an effective remedy after the fact through the product liability system. Especially it is imperative to make a legal regulation that considers a feature of medicine by special legislation.