• 의료법학
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• 제8권1호
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• pp.235-277
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• 2007

In Product Liability law, the 'defection' of the manufactured products is its key concept, defined in detail. The concept had been already developed through the precedents and theories for the past years even before the PL law was enacted and the concept was listed. Especially, the medicine products need the different approach, because they might directly harm to the human life and body due to their being injected or taken, unlikely other manufactured articles. Since the medical products have the double contradictory functions such as effects and side effects, the defection decisions become so difficult. However, because there are high concerns that wrong medical products will directly harm the human life and body, the decision standards should be more strengthened. The decision standards should include the risk-effect standard as the considered components and make the customer-expecting standard as the final standard. The decision time for defection should be made considering the science technology level when the medical products were provided, not when the accident occurred. It is the most important for the manufacturers to prevent the damages by making and selling the non-defective medicine products for themselves, rather than by taking the legal remedy means afterwards. Therefore, the non-defective guidelines for the medicine manufacturers will help increase the effects and minimize the side-effects.