• The Korean Society of Law and Medicine
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• v.8 no.1
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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.

• The Korean Society of Law and Medicine
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• v.10 no.1
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• pp.213-260
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• 2009

While the medical supplies have positive functions such as extending lifespan, recovering health, and preventing diseases, they also cause unexpected tragic consequences due to their side effects, and the magnitude of such damage inevitably increases due to the mechanism of mass production, mass distribution, and mass consumption of those medical supplies. Therefore, needless to say, the optimal way to prevent or reduce such damage is rather through medical supply manufacturers' producing non-defective products, or through the government's controlling production and sales of medical supplies with more aggressive exercise of regulatory authority on medical supply manufacturers, than through a remedy by a legal relief after using medical supplies. In this case, although the victim died due to the defect of the cold medicine, 'CONTAC 600', the drug company's responsibility to cover damages was not recognized because a defect could not be found in the then-manufacturing process. Thus, while pharmaceutical companies are gaining economic profits by producing and selling a medical supplies, if they do not take any remedy measures for the victims of their products' side effects, the victims have to use medical supplies under their own responsibility of taking a risk, and they have to accept the full damage of the potential consequence. Therefore, to remove such absurdity and contradiction, and to practically remedy the victim of medical supplies' side effects, the pharmaceutical side effects remedy project pending in the the Drugs, Cosmetics and Medical Instruments Lawneeds to be actively implemented.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.3-28
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• 2016

While product liability has been settled as a technical term in civil law, criminal law does not commonly accept technical term for it. Not like civil law, product liability in criminal law point outs individual responsibility and disability of normative order. Meaning that causation between individual's action of violation of duty and the result of danger of legal interest or infringement of legal interest must be proved. In criminal law excluding "non-result-constituted crimes (Unternehmensdelikt)", charge of injuring, accidental infliction of injury, homicide or involuntary manslaughter is problematic in product liability. Of course, it is necessary to distinguish whether the action related to the outcome is act or ommission. Also the causal relationship between the action and the result must be proved, and the intention or negligence should be recognized. In this paper, it analyzes cases that were problematic in Korea, Germany, Spain, etc. Mainly focusing on the problems revealed in the determination of causal relationship, especially recognizing criminal liability related to products. Furthermore it is followed by the view of reviewing the cause-and-effect relationship by 2 steps, dividing natural scientific causation and the normative causal relationship. In this process, to acknowledge criminal product liability in accordance with recognizing cause-and-effect relationship, there should be general risk of specific substance causing the outcome. This only premise can be meaningful to examine the casual relationship from specific cases. As it shows in some cases and theories, it is not contradicting general law of cause and effect by determining specific causal relationship by free evaluation of evidence if a general causal relationship does not exist. Also since judge's testimony does not hold a dominant position from rule of thumb, it is possible to recognize specific causal relationship. However this paper takes position that if there is no objective and reasonably undeniable cause and effect law. If there is no objective and reasonably undeniable causal law, which is the premise for recognizing concrete causal relations, judge should sentence guilty according to "in dubio pro reo" principle. In addition, it is not allowed for the defendant to burden unproven fact by free evaluation of evidence which has an effect of shift of burden of proof.