醫療事故之責任歸屬與因果關係─兼論台灣全民健保及實證醫學之發展影響

The Liability and Causation of Medical Malpractice Litigation -- concerning about The Influence of developing Evidence-based Medicine and the National Health Insurance in Taiwan

系所名稱：法律學系研究所 學位別：碩士 畢業學年：97年 指導教授：姚志明 近幾年來，台灣醫療糾紛與法律訴訟案例日漸增多，醫療與司法人權之是非公理正義晦暗不明，醫療人權、司法人權、病患人權、醫師人權、護士人權等權利與義務衝突，總應該有個真理存在吧？人生無常，要細觀因果，善求智慧；行醫執法，求真理行正義。因果與正義，是否就是佛、道、醫、法的共同真理呢？ 醫療事故之民事法律責任，在侵權行為或醫療契約上，其責任歸屬與損害賠償責任，皆必須以因果關係之成立為要件，亦即損害賠償之責任義務，係以行為與損害結果之間存在因果關係為前提。進而言之，因果關係於侵權行為法上有二項功能，其一為判斷侵權行為是否成立，其二為判斷損害賠償之範圍。實質上，醫療事故之損害賠償責任是否成立，須分析以下三項因素：一、行為人之行為分析：行為人之侵害行為係出於故意、過失，是否違反注意義務，製造風險，違反經驗法則，而侵害被害人之權利或利益。二、事實上因果關係：行為人之加害行為與損害結果之間，是否具有事實上因果關係，亦即行為人之行為對於被害人人身或財產上損害，是否具有符合經驗法則與論理法則之原因力。三、法律上因果關係：行為人之加害行為對於損害，是否具有法律上因果關係，亦即在事實上因果關係具備時，行為人之侵害行為，未因法律政策或其他因素之考量而免除賠償責任，而應負責多大之損害賠償範圍。透過比較法上，德日英美法之觀察研究，現行醫療事故之法律責任歸屬與因果關係，在實務判決以及因果關係學說上都有所批判，理想的法律審判模式中，是如何進行因果關係判定呢？以法理學的角度觀之，社會科學上之因果說明，論者有謂可歸納出以下二點，第一、不論明示或默示，任何一種對因果關係之說明皆以一定的法則之存在為前提。第二、原因與所謂結果之間的關係並不是一種絕對關係，僅具備某種經常性的法則。如何提高法解釋學的客觀性，有兩個途徑，一是由邏輯分析的方法來著眼，二是由經驗科學的研究方法，充分吸收法社會學，法心理學，法制史學等法律經驗科學的研究成果，唯有提高事實部分的因素，方可提高法律解釋的客觀性。另以實證法學的角度加以探討，就犯罪或侵權現況之實證研究，論者有謂法律研究者往往僅憑主觀印象進行判斷，這般研究或決策存在相當大的風險。就某些法學研究或政策決斷的議題而言，先經由實證研究來了解現狀，是將來能做出正確法學研究或政策的必要手段。本研究就醫療事故之因果關係與責任歸屬的探討為主軸，以文獻分析法、比較研究法及綜合歸納法，分析國內外之學說理論與實務判決見解，歸納研究相關因果關係之經驗與論理法則，並對因果關係之理論重新再思考，以法理學、邏輯學、經驗科學、分析哲學以及批判性思考研究之方法，重新省思如何提高法律解釋與適用的客觀性，確認經驗法則與論理法則對因果關係之重要性，本文首先也肯定醫療事故責任因果關係體系採取責任成立與責任範圍二元論之合理性。此外，繼往開來，觀察台灣現行實證醫學與實證法學之發展，對於醫療事故責任歸屬與因果關係判定，可預料將有重大影響，基於前述分析因果關係學說理論之運用現狀與過去沿革，本文綜合法學解釋適用之論理演繹方法，與醫學診斷治療之歸納分析方法，於本研究中進而提出一假說，醫療事故責任因果關係之三階段分析，或謂醫療事故責任實證法學三階段因果論如下：一、侵害行為機轉分析(BMA, behavior mechanism analysis) 。二、事實因果成立分析 (CEA, cause effect analysis)。三、法律因果利益衡量 (LEA, legal evaluation adjustment) 。一、侵害行為機轉分析(BMA, behavior mechanism analysis) 對於一般生活經驗(common life experience)如：殺人、傷害、搶劫、偷竊、侵佔等等損害，依常理即可判斷其因果關係。但是對於特殊事件歷程(special event sequence) ，如車禍事件、醫療事件、金融掏空、貪污洗錢、高科技犯罪、電腦侵權等事件，則可能需要藉由科際整合(interdiciplinary integration)，以進行詳細之行為機轉分析(behavior mechanism analysis)，才能嚴謹地進行下一步，因果關係成立與否的判定。必要時亦須參考的科際整合基礎背景知識，如行為科學(behavior science)，心理學(psychology)，管理科學(management science)，作業流程分析(operation analysis)，醫學診斷學(medical diagnosis)....等等，透過專家的經驗法則與客觀證據，對於複雜侵權行為程序，才能判定事實上因果關係是否成立。台灣在現行全民健保制度下，相關法規組織制度，如健保局，醫院評鑑暨醫療品質策進會，透過總額預算與給付審查制度，醫院評鑑制度，專科醫師繼續教育之品質倫理法律必修學分，促成醫療品質，醫療倫理，醫療法律，以及實證醫學之積極發展，國家衛生研究院亦建立實證臨床指引知識平台。實證醫學之積極發展，伴隨醫療品質外部認證，使醫療行為之標準作業程序，客觀的診療義務標準，越來越客觀，越來越具體，可資醫療訴訟雙方當事人，於證據調查程序爭點整理，對所謂義務違反的醫療行為，有共同的辯論焦點，以期發現客觀醫療事故之真實，確保醫病雙方之權利保護，公平解決醫療事故紛爭。綜上，侵害行為機轉分析(BMA, behavior mechanism analysis)，應是醫療事故責任歸屬與因果關係之第一道重要檢驗分析步驟。二、事實因果成立分析 (CEA, cause effect analysis) 進行詳實的行為機轉分析後，透過客觀證據的分析歸納，邏輯理性的推理演繹，才能分析出眾多條件原因，比較其原因力大小排序，最後才能做出適切判斷，侵權人行為因果關係之高低，如此也才能進行下一階段，侵權責任範圍的判定。客觀證據歸納(objective evidence)包含經驗法則，鑑識科學，專家鑑定，法醫學....等專業知識；因果邏輯分析(logic analysis)則可參考管理科學，問題分析診斷模式，魚骨圖分析，傷病診斷流程，實證醫學....等等因果分析流程。進行因果關係判斷，首先要進行眾多條件原因之原因力高低排序，鑑別出其他原因， 雙重因果，超越因果，因果中斷，不可抗力因素，法所容許之風險，繼而分析侵權人原因力大小，以及判斷侵權人因果關係高低，區分出高度因果關係，或是中低度因果關係。此外，亦須區別主要或附加損害結果，直接或間接損害結果，此亦須依經驗法則及論理法則，證據證明方法，參考專家鑑定，個人學識經驗，法官邏輯推理，建立心證理由。而統計學研究方法，質性研究法及實證法學的發展，有助於上述經驗法則及論理法則的客觀性，合理性，公信力與判決品質。三、法律因果利益衡量 (LEA, legal evaluation adjustment) 法律上因果判斷，涉及法律規範評價與立法政策，三方利益衡量下，如何均衡考量受害人保護，加害人責任，以及法體系秩序，通常難有客觀標準，學說紛陳，有合理可預見說，法規保護目的說，相當因果關係說，客觀歸責理論等等。至於責任範圍判斷，根據直接或間接損害結果，進行利益衡量，亦有賴經驗法則及論理法則，法官邏輯推理建立心證理由。惟因果判定與利益衡量原則，不能違反法有明定之經驗法則與論理法則，雖難有具體客觀之量化標準，然而科際整合的品質理論似乎可提供一些借鏡，如管理學品質理論，企業決策品質理論，醫療品質理論等等。可預期隨著實證法學的開創發展，透過品質研究方法，實証法學，統計學研究方法，質性研究法，以及科際整合的相輔相成，也許日後學界或實務界會訂定一些具體判決品質準則，或因果關係判定品質原則，如合法性、明確性、合理性、客觀性、實證性等等，甚至產生更新更實用的因果關係理論。醫療事故在全民健保多面法律關係下之法律責任，有民事責任、刑事責任、以及行政法上之責任，現行實證醫學之發展對於醫療事故責任歸屬與因果關係判定將有重大影響，本文認為，藉由實證醫學之文獻統計證據資料，全民健保法規範下臨床指引，專科醫學會診療共識，以及系爭個案醫療行為之行為機轉分析，對於釐清義務違反之醫療行為與不可避免之醫療風險，逐漸可達成當事人爭點整理方法更細緻、更具體以及更客觀之目標，以提高法律解釋與適用的客觀性，如此透過實證醫學與實證法學之相輔相成，建立醫療事故實證法學三階段因果論，確立公平客觀真實之醫療事故責任歸屬，始可期醫療法律責任衡平，法理因果正義之實踐。在法律上，重視的是醫學研究文獻在法庭上的證據能力；而在實證醫學上，則強調醫學研究文獻的證據等級。實證醫學的基本精神，在於必須依照客觀的醫學研究文獻來診療病患，同時也強調研究品質的評鑑，必須以臨床流行病學的知識來評論醫學研究文獻的品質及其可信程度。如果不同的專家各依不同結果的醫學文獻，來做為法庭上的醫療糾紛證據時，法官應該以何者的意見為依歸呢？實證醫學強調的是醫學研究文獻的客觀證據能力，則實證醫學就不應僅依專家的主觀意見，來決定醫學研究文獻的證據等級。因此，一旦法庭採用實證醫學的精神，以決定醫學研究文獻的證據能力，對於醫學專家證人在法庭上的角色，法院仍須參考實證醫學的客觀標準。本文認為，醫學界已將醫學研究文獻的證據等級做為診斷、治療病患的共同客觀標準，未來法律人對於相關醫療糾紛案例之醫療事故鑑定，也將逐漸參考系爭案件之鑑定，是否有實證醫學的客觀標準依據，以決定其在法庭上的證據能力。可預見地，會有越來越多的醫療糾紛案件，將引用醫學研究文獻做為攻擊或防禦的工具，面對這些專業的研究文獻與醫學專家證言，仍必須以實證醫學觀點來分析，以做為該個案之證據。在論文結構上，本文探討醫療事故之因果關係與責任歸屬，首先將於第一章緒論，敘述本論文之研究動機、研究目的、研究方法與研究範圍，第二章起，則就醫療行為的定義及特性，醫療義務及醫事人員之義務，與醫療事故的定義、成因及特性，先進行概念釐清，特別著重於醫療義務與義務違反之定義。第三章起，則對醫療事故責任之相關實體法請求權基礎，如醫療契約責任，醫療侵權責任，消費者保護法上之責任，民法一般危險責任，嘗試進行醫療訴訟之案例類型化與請求權基礎法律分析，以分析現行民事損害賠償之法律關係與歸責體系。第四章起，分析因果關係之概念，以及對台灣現行因果關係之學說理論與實務提出批判分析，進而以比較研究法，分析驗證國內外之學說理論與實務判決見解，如德國法、日本法、及英美法之因果關係的理論，以文獻分析法，分析驗證國內外之學說理論與實務判決見解，並對相關因果關係之經驗與論理法則，提出綜合歸納研究。第五章起，以醫療事故責任之因果關係為核心，對因果關係之理論重新再思考，以法理學、邏輯學、經驗科學、分析哲學以及批判性思考研究之方法，重新省思如何提高法律解釋與適用的客觀性，確認經驗法則與論理法則對因果關係之重要性，同時也肯定醫療事故責任因果關係體系採取責任成立與責任範圍二元論之合理性，並觀察分析侵權行為與因果關係判定思考模式，進而提出一假說，醫療事故三階段因果論，藉以進一步研究分析實務案例，以驗證實証法學三階段因果關係理論運用之可行性與有效性。 第六章起，鑑於現行全民健保與實證醫學之發展迅速，對於醫療事故責任歸屬與因果關係判定也將有重大影響，最後於第七章做出結論，本文認為，藉由實證醫學之文獻統計證據資料，全民健保法規範下臨床指引，專科醫學會診療共識，以及系爭個案醫療行為之行為機轉分析，對於釐清義務違反之醫療行為與不可避免之醫療風險，逐漸可達成當事人爭點整理方法更細緻、更具體以及更客觀之目標，以提高法律解釋與適用的客觀性，如此透過實證醫學與實證法學之相輔相成，建立醫療事故實證法學三階段因果論，確立公平客觀真實之醫療事故責任歸屬，始可期醫療法律責任衡平，法理因果正義之實踐。

In recent years, medical disputes and the legal proceeding cases increases day after day in Taiwan. The justice, right and wrong, or the truth is unclear and gloomy among medical human rights, judicial human rights, human rights of patients, human rights of doctors, human rights of nurses, and so on. Is there eternally any common truth in the continuous conflict among the medical-legal relation, right, duty and the correlative liability? The life science and the life are variable and changeable, they are necessary and worthy for us to observe carefully the causes and effects, and to find a proper way of wisdom. To find the truth and to perform the justice are essential not only in medical profession, but also in the application and enforcement of the law. Is the principle of cause and effect eternally the common truth of the justice performing, the morality, the religion belief, the Buddhism, the medical practice, and the legal profession? The civil legal liability and medical damages of medical malpractice, in the tortious responsibility as well as in the medical contract, are based upon the identification of the causal relation as a premise, which confirms the damage compensation responsibility according to the cause-effect relation between the medical behavior error and the medical damage. In addition, there are two major functions of the causation in torts. The one of them is to identity the accomplishment of liability; the other function is to decide the scope of the damage compensation.Substantially three factors must be taken into account in the medical malpractice liability as the following. Firstly, the most important factor is the behavioral analysis: Is the violation behavior stemming from intention or error, breaching the duty of care, creating the unnecessary risk, disobeying the experience rules, invading rights or interests of the victim. Secondly, the cause in fact, the factual causal relation: to clarify the cause-effect relation in fact between the invasion behavior and the damage. Does the behavior result in the damages of the physical health or the property, and does it contribute to the causal strength in accordance to the principles of experience rules and the logic principles? Thirdly, the cause in law, the legal cause: to evaluate the cause-effect relation in law between the invasion behavior and the damage result. Once if the factual cause were identified, the method and extent responsible for the damage compensation could be decided, in case of no immunity from the compensation responsibility under the legal policy or other values consideration.Under the comparative research study and observation analysis among Germany, Japan, England-America and Taiwan laws, there are a lot of criticism to the practical judgments as well as to the present causation theories regarding civil liability and medical malpractice. What is the ideal legal trial model applying the appropriate causation determination?In jurisprudence, cause and effect in social sciences could be inducted to the following two points of view. The first one is that no matter indicated clearly or implied, any kind of explanation to the causation could take a certain principle as a premise. Secondly, the relation between cause and effect is not absolute, but a constant rule. How to enhance the objectivity of legal interpretation? There are two ways of resolution, one is focused on the logic analysis method, and the other is the research technique of experience science, which fully absorbs the research results from the law sociology, the law psychology, the legal system history, legal experience sciences and so on. Only if we enhanced the factual factors, we could enhance the objectivity of legal interpretation. In empirical study, legal researchers are used to making judgment by subjective impression, which is risky in doing research or in policy-making, according to the empirical legal study associated with crime or torts. It is more appropriate and necessary to do legal research or to make policy through empirical studies based on facts and evidences.This article is centered on the causation and liability of medical malpractice and medical accident. It is organized by literature survey method, comparative research study, and analytic induction from the domestic and foreign theories associated with the principles of experience rules and logic. Furthermore, we deeply pondered again over the theory of causation in order to enhance the objectivity of legal interpretation, by means of jurisprudence, logic, experience science, analytic philosophy, as well as critical thinking. Originally this article also agrees the two-stages-theory (the Dichotomy Theory) of causation and liability, that is, the causation can be divided into the factual causation and the legal causation. The factual causation should be judged by the medical science, while the legal one should be judged by the legal regulations with the help of the related causation theory, which could be rationally adopted in medical malpractice. In addition, according to the past academic theories, present situation, and future vision, I predict that evidenced-based medicine (EBM) and empirical legal study (ELS) will significantly impact on the causation and liability of medical malpractice in Taiwan. Therefore I try to propose a hypothesis which was based upon legal research method and medical research method, including logic deduction method, induction analysis method, experience science, medical diagnosis and treatment model, evidenced-based medicine and empirical legal study. That is a new three-stages-theory (the Trichotomy Theory) as the following: Firstly, mechanism analysis of medical behavior, (BMA). Secondly, factual cause analysis, cause in fact (FCA). Thirdly, legal evaluation and legal adjustment, legal causes, (LEA, legal evaluation adjustment).The structure of this paper is designed and focused on the causation and liability of medical malpractice as a systematic interpretation as the following: Chapter I introduces the writer’s initial motives, purposes, methods and the range of this research. Chapter II defines the concepts of the characteristic terms, such as medical behavior, medical guideline, medical accident, medical error, medical negligence, medical malpractice, medical dispute, medical litigation, medical liability, duty of care, and breach of duty of care. Chapter III describes and analyzes the varieties of civil liability resulting from medical malpractice, such as contract liability, torts, consumer protection law, strict liability, burden of proof, and informed consent. In chapter IV, I review the various concepts about the causation, analyze the associated causation theory in Taiwan, and compare the different foreign academic causation theory, such as German, Japan, and the United States. In chapter V, I repeatedly studied over the theory of causation in order to enhance the objectivity of legal interpretation, by means of jurisprudence, logic, experience science, analytic philosophy, as well as critical thinking. I try to propose a hypothesis which is a new three-stages-theory (the Trichotomy Theory) as the following: Firstly, mechanism analysis of medical behavior, (BMA). Secondly, factual cause analysis, cause in fact (FCA). Thirdly, legal evaluation and legal adjustment, legal causes, (LEA, legal evaluation adjustment). In chapter VI, I reviewed the concepts and the development of Evidence-base medicine（EBM）in medical profession field, then accordingly introduces the assessment of the application of the EBM in medical malpractice. I reviewed about the possibility and effect of using the EBM for surveying the medical expert opinions. Besides, I predict that evidenced-based medicine (EBM) and empirical legal study (ELS) will significantly impact on the causation and liability of medical malpractice in Taiwan. Chapter Chapter VII is a summary and conclusion presented according to the analysis results of above chapters. To find the truth and to perform the justice are essential not only in medical profession, but also in the application and enforcement of the law. The principle of cause and effect might be eternally the common truth of the justice performing, the medical practice, and the legal profession. How to enhance the objectivity of legal interpretation? Only if we enhanced the factual factors, we could enhance the objectivity of legal interpretation. The most important factor of causation is the behavioral analysis, in order to identify the following points of contention, such as breaching the duty of care, creating the unnecessary risk, and disobeying the experience rules, which were reliably based on the evidence-based medicine and empirical legal study.