임상시험 단계의 의료행위에 대한 설명의무 위반과 손해배상의 범위 ― 대법원 2015. 10. 29. 선고 2014다22871 판결을 중심으로 ― = Violation of the Explanation Duty to Medical Practices at the Clinical Trial Stage and Scope of Compensation for Damages

다국어 초록 (Multilingual Abstract)

With advancements in medical treatment techniques, countless new health technologies are beginning to surface. It has become conventional to see medical treatment advertisements that boast its new surgical techniques in plasticㆍcosmetic surgery that have absolutely no side effects and ensures safety. Courts have declared such medical practices without basis on any clinical experience that proves its safety and its effectiveness to be considered `medical practices in the clinical trial stage` and make decisions on the scope of compensation for damages differently from those of ordinary practices in cases of violation of the explanation duty. Therefore, this dissertation examines rulings that focus on the scope of compensation for damages for violating the explanation duty of medical practices in the clinical trial stage and suggests standards to determine the scope of compensation for damages.
The scope of compensation for damages that occur due to violation of the explanation duty should be limited to solatium in principle but full-damage compensation should also be recognized in exception in order to guarantee specific validity. It should not be decided uniformly but rather be decided according to specific matters. This is likewise for rulings on the cases of medical practices in the clinical trial stage. Thus, even if one violates the explanation duty that the medical practice is in its clinical trial stage, it should not be considered to be at a level of violating the explanation duty in cases of malpractice and proximate causal relations with key results, and the degree of validation required should not be expected to be at a lower level. Rather, it must be determined, in consideration of the factual grounds, whether full-damage compensation should be acknowledged. If we distinguish the ordinary explanation duty from the explanation duty for medical practices in clinical trial stage and consider the lack of explanation in both cases, the degree of violation of the explanation duty is regarded serious and as a result, it will be easier from the patient`s perspective to prove whether the violation can also be regarded as malpractice and to confirm the proximate causal relation with the result. However, in case one has fulfilled the general explanation duty but has failed to explain that the medical practice is in its clinical trial stage, the standard of proof cannot be lowered by the fact that the medical practice is in its clinical trial stage and if one fails to provide any solid grounds, the form of compensation will return to normalcy and simply be in that of solatium.
The reason as to why one takes a passive stance in acknowledging full-damage compensation is because as the explanation duty, in theory, is based on protecting the self determination, or rather the personal rights of the patient, it is only fair in principle that the scope of compensation for violation of explanation duty be limited accordingly. However, as today`s society continues to become more complex and diverse and thereby changes the framework of medical litigations, the necessity to make judgments that are sometimes contrary to principle remain in existence. In conclusion, there must be a balance maintained between considering the good of the patient, which is the weaker party due to the asymmetry of information, and making sure that advances in medical practices are not hindered.