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KMID : 0986720050130010007
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Korean Journal of Medicine and Law
2005 Volume.13 No. 1 p.7 ~ p.39
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The Development of the Theory on the Medical Product Liability
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Moon Seong-Jea
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Abstract
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Few cases of medical product liability have been reported in Korea so far. Nevertheless, the use of medicine is critical for the maintenance and recovery of human life. As medical science and service have developed and become popular, medical care and the use of medical products are inseparable. Today, there is a high demand for the development of useful drugs. Therefore, we can easily predict that misuse of medical products could result in many accidents.
Composed of synthetic chemicals, drugs can cure diseases and preserve health by generating chemical reactions, while they also have harmful effects on the body. That is, drugs can have adverse effects not yet confirmed, and the consequent damages could be substantial, given the drugs are widely used in the national or global dimensions. The establishment of the general causality between the use of a drug and the consequent damages could require highly professional knowledge or tremendous amount of money and time. As a result, being financially disadvantaged the victim of the damage can’t actively cope with the case. Meanwhile, it would be inequal as well if all the damages are claimed to the manufacturers. Even if the causality between the use of a drug and the consequent damages were proven, the error in the part of the manufacturer should be proved to claim for the damages. The usability of drug is determined based on the balance between its efficacy and safety, and this determination should be difficult given that drugs are foreign substance to the human body and that the interventions of the third part(e.g. physician) are required in the administration of the drug. Consequently, it would be necessary to prepare measures or techniques to prevent medical accidents in the use of dugs. Further, medical professionals should confirm what is required to them at the time of a medical accident-what actions are recognized as an error, what cautions are legally required to them, who will bear which responsibilities in the accident. Recognizing these problems, this paper discusses intensively the liability of drug manufactures. However, it is not easy to fmd any case of medical accidents where the liability of drug manufacturer was discussed as a direct factor. On the other hand, many pharmaceutical companies have faced increasing number of recalls due to the problems originated from the manufacturing method of drug. To develop a theory on the medical product liabilities, this paper analyzed the cases in many foreign countries and attempts to find the solutions for the general problems concerning medicine that can appear in Korea in the future.
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KEYWORD
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Chloroquine Phosphate, Aralen, Periodic visual field exam, FDA, Proximate cause, Salk Vaccine, Polio Vaccine, Restatement of Torts 3d, Live Virus, Unavoidably unsafe product
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