의약품의 설계상 결함으로 인한 제조물책임 - 미국의 리스테이트먼트와 판례이론을 중심으로
Product Liability for Defective Drug Designs
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Deciding liability for defective drug designs have to consider drug designs are different from other products. Because drugs have characteristics that are chemical compounds designed to interact with the chemical and physiological processes of the human individuals. Drugs are most cost-effective input in supplying the demand for health. Comment (k) to the Restatement (Second) of Torts §402 A creates an exception to strict liability for "unavoidably unsafe" products. The vast majority of cases that apply comment (k) have involved drugs,vaccines, blood, and medical devices. The Restatement (Third) of Torts uses foresight in all design, it does not require a section exempting drug and medical device manufacturers from strict liability. However it has a special provision(§6), a prescription drug is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers,knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients. A Product is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design and the omission of the alternative design renders the product not safe. Therefore courts that decide liability for defective drug designs,they have to apply risk-utility balance test on a case-by-case basis. I dissent that all drug are exempt from strict liability for design defect, even though alternative drugs can provide the same or even better, therapy, with less risk to life or health. I dissent categorical exemption like prescription drugs by health-care providers. A broad range of factors may be considered in determining whether an alternative design is reasonable and whether its omission renders a product not resonably safe(§2.2). KFDA(Korea Food & Drug Administration) safety procedures and its approval do not justify abdication of judical responsibility.
Abstract
Deciding liability for defective drug designs have to consider drug designs are different from other products. Because drugs have characteristics that are chemical compounds designed to interact with the chemical and physiological processes of the human individuals. Drugs are most cost-effective input in supplying the demand for health. Comment (k) to the Restatement (Second) of Torts §402 A creates an exception to strict liability for "unavoidably unsafe" products. The vast majority of cases that apply comment (k) have involved drugs,vaccines, blood, and medical devices. The Restatement (Third) of Torts uses foresight in all design, it does not require a section exempting drug and medical device manufacturers from strict liability. However it has a special provision(§6), a prescription drug is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers,knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients. A Product is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design and the omission of the alternative design renders the product not safe. Therefore courts that decide liability for defective drug designs,they have to apply risk-utility balance test on a case-by-case basis. I dissent that all drug are exempt from strict liability for design defect, even though alternative drugs can provide the same or even better, therapy, with less risk to life or health. I dissent categorical exemption like prescription drugs by health-care providers. A broad range of factors may be considered in determining whether an alternative design is reasonable and whether its omission renders a product not resonably safe(§2.2). KFDA(Korea Food & Drug Administration) safety procedures and its approval do not justify abdication of judical responsibility.
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