實證指引對醫療侵權行為過失判斷之影響

The Influence of Evidence-Based Guidelines on the Standard of Care in Medical Malpractice

林靖苹(Ching-Ping Lin)

指導教授 ： 陳聰富

共同指導教授 ： 王明鉅(Ming-Juih Wang)

國立臺灣大學/法律學院/法律學研究所/碩士(2012年)

https://doi.org/10.6342/NTU.2012.00350

摘要

提供我國民事法院一套明確、穩定、具可預見性及可操作性的醫療過失判斷標準，是本文的起點，也是本文的終點。
我國民事醫療過失案件之審理機制，不論程序或實體，均面臨整體社會的信心危機。依臺中地方法院林三元法官於2009年就我國醫事專業法庭民事庭之成效研究結果，相較於一般民事案件，醫療過失案件呈現「審理期日冗長」、「一審判決折服率低」及「上級審維持率偏高」之三大現象，由此可知醫療過失案件之審理往往耗日費時，然而當事人對於審理結果卻難以信服，而上訴審級是否發揮應有之救濟功能亦令人存疑。
經分析我國近年醫療侵權過失實務見解後，本文發現形成上開現象之主因在於我國實務一向欠缺明確、穩定、具可預見性及可操作性之醫療過失判斷標準，而產生（一）注意義務標準不一（二）醫療常規內涵不清（三）輔助鑑定機制不足等三大問題。詳言之，法院判斷侵權過失責任之標準往往欠缺一致性，就同一案件，法院所持注意義務標準截然不同者、見解反覆者，皆不在少數。又縱然多數法院皆以「醫療常規」為過失判斷標準，惟各法院就「醫療常規」之解釋與適用卻產生顯著差異。最後，欠缺醫療專業之法院雖然高度仰賴鑑定機關，然因鑑定機關時常未提供其意見之證據基礎，司法上又欠缺可行之檢驗機制，導致法院動輒進行重複鑑定，當事人亦常有「醫醫相護」或「醫醫相害」之譏。
本文認為，欲解決上開醫療侵權過失實務問題，必須重新釐清注意義務之內涵與判斷架構，建立明確、穩定、具可預見性及可操作性之醫療過失判斷標準。基於此問題意識。本文對我國醫療侵權過失審判實務，提出以下建議：
一、 應改變目前「以醫療常規之名，行理性醫師判斷之實」之注意義務判斷標準，讓「醫療常規」回歸至單純之事實概念，而非具法規範意義之價值判斷，至多僅係法院進行理性醫師判斷時其中一項參考。
二、 應肯認實證指引（Evidence-Based Guidelines）之特殊證據價值，與鑑定意見相輔相成。蓋實證指引係指以實證醫學為方法與基礎，經專家共識形成之醫師臨床行為建議，亦為醫界近年來自發形成，以提昇醫療品質、降低醫療浪費為目的之臨床行為標準化運動，具備科學知識之正當性及明確之可預見性，故本文認為針對符合一定條件之實證指引，法院應賦予其特殊之證據價值，而與具備事後、個案性質之鑑定制度，交互運用。
三、 應以實證指引作為醫療侵權過失所涉注意義務之判斷標準，本文並嘗試提出操作實證指引之決策樹如下：（圖請參見論文紙本或電子檔摘要全文）

最後，本文以「台灣腦中風防治指引2008」實證指引作為標準，挑選我國實務曾發生之多則急性缺血性腦中風案例事實，依上開決策樹進行過失判斷，以確認該決策樹確實具有實務上之可操作性，並期待藉此明確、穩定、具可預見性之醫療過失判斷標準，有助我國法院日後能走出象牙塔之司法判斷，除重新檢視目前醫療侵權過失判斷標準之問題外，更能與時俱進、了解實證指引此一新工具之優點與其極限，再度肯認醫療行為之特殊性與有限性，做出合於社會期待、公平之過失判斷。

關鍵字

醫療侵權過失責任 ； 注意義務標準 ； 醫療常規 ； 實證指引 ； 實證醫學 ； 臨床準則 ； 醫療糾紛

並列摘要

This thesis aims at providing a clear, predictable, and practical judicial standard of care in medical malpractice cases. The judicial system for medical malpractice is experiencing a crisis of confidence in Taiwan. Nowadays, empirical studies show that, for a district court to close a medical malpractice case, it takes four hundred (400) days more than an average civil case. However, the percentage for a party or both parties taking an appeal is substantially higher, which suggest a lower satisfaction of court’s decision by the parties in a medical malpractice decision. In addition, waves of criticism of unfairness are casted upon the court’s decision on medical malpractice cases. This suggests a serious problem of inefficiency and ineffectiveness in our judicial system of medical malpractice.

After analyzing the recent judicial decisions on tort liability of medical malpractice cases, this thesis argues that the core issue is the unstable and unpredictable standard of care. First, the standard of care held by courts lack consistency. Most courts use the term “medical custom (醫療常規)” as the standard of care; however, the definition of “medical custom” is unclear and ambiguous and so its application. Some other courts choose to apply its own standard, but usually results in an imposition of an impractically high expectation on physicians. Furthermore, the system of expert testimony (*in Taiwan, the expert testimony is usually given by medical institutions and Medical Review Board in out-of-court written statements), which the courts rely heavily upon, has long been criticized as prejudicial and lack of transparency by both patients and physicians. This unfair, unpredictable practice of the determination of standard of care further erodes both parties’ faith and that of the society in judicial system.

To solve the problems above, this thesis proposes the following solution:

1. Re-define “medical custom” and Re-affirm the standard:
“The reasonable physician standard” is a standard that has been adopted by the courts for a long time in the name of “medical custom.” This thesis proposes that such confusion must be clarified, and the term “medical custom” must be re-affirmed as simply representing “the physicians’ general practice.” Although medical custom is an important factor to be considered when deciding “the reasonable physician standard”, it is not appropriate to make it equal to medical custom as standard of care.

2. Accept “Evidence-Based Guidelines” as a new tool in determining standard of care in addition to expert testimony:
Evidence-Based Guidelines are the suggested optimal clinical practice guidelines for physicians based on Evidence-Based Medicine. It represents the self-awareness to create standardization in medicine to improve the quality of physicians’ decision-making, and has been practiced for decades. Even though the U.S. legislation and academic discussions suggest a conservative attitude towards the use of Evidence-Based Guidelines in determining standard of care, this thesis proposes a different view.

This thesis argues that Evidence-Based Guidelines, if understood and applied correctly by the courts, has a special value on standard of care and could compensate for the insufficiency in expert testimony. Evidence-Based Guidelines have solid scientific grounds based on Evidence-Based Medicine and further provides predictability as pre-existing guidelines. Therefore, it could help eliminate the concerns of fairness and lack of transparency in regard to expert testimony. On the other hand, the expert testimony could also assist the courts to understand and apply an Evidence-Based Guideline in the case at issue. With the cooperation of both Evidence-Based Guidelines and expert testimony, the court is better equipped to determine optimal standard of care.

3. The thesis further suggests that Evidence-Based Guidelines should be the primary standard that a court uses to determine standard of care. The proposal could be shown in the decision tree chart provided in this thesis and is briefly explained as follow:
a. For the physicians who live up to the standard declared by an Evidence-Based Guideline, the court should give credit for their compliance as “non-negligent” because such standard is usually higher than the judicial expectation towards a reasonable physician. Therefore, an Evidence-Based Guideline could act as a safe harbor, which not only encourages physician to practice Evidence-Based Medicine (thus improving the quality of medical care) but also decreases defensive medicine.
b. In addition, for the same reasons stated above, the standard of care declared by a court could not exceed the standard suggested by an Evidence-Based Guideline without special justifications. This could help prevent a court from imposing impractically high standard on physicians and rendering tort liability arbitrarily.
c. For the physicians who is seriously departed from an Evidence-Based Guideline, the court must impose “an obligation to explain” to them. Deviation from an Evidence-Based Guideline does not necessary equal negligence because such standard is usually higher than what is required from a reasonable physician. Yet because every medical decision should be a rational decision, a deviating physician should at least provide legitimate reasons for his/her deviation. And for those physicians who refuse or fail to provide reasonable grounds for their deviation, the court is at its sole discretion to render negligence. This mechanism helps court to distinguish those clinical behaviors that may fall below the reasonable standard of care at the very beginning of trial, and helps to enhance full disclosure and exchange of information that would ultimately contribute to the discovery of truth.

In order to show the feasibility of my suggestion, this thesis further demonstrates the application the “Taiwan Guideline for Management of Stroke 2008,” a widely accepted Evidence-Based Guideline promulgated by Taiwan Stroke Society, in real medical malpractice cases to examine the role of Evidence-Based Guidelines in determining of standard of care.
In sum, this thesis aims at (1) introducing the new tool－Evidence-Based Guidelines－to the judicial decision-making process in medical malpractices cases and (2) proposing a new solution in determining the standard of care. However, one core issue for the court and the society to bear in mind is that, no matter how far the medicines advances, medicine is and will always be a mix of art and science, operated by human beings. Therefore, no matter how determined the court is to pursue justice, the court should always understand that “to err is human” and render every judgment with great care as well as the awareness of the influence a decision would have on physicians’ behavior; such awareness and duty of care exercise by the court would eventually determine the overall medical care that the society receives in the future.

並列關鍵字

medical malpractice ； negligence ； standard of care ； medical custom ； Evidence-Based Guidelines ； Evidence-Based Medicine ； Clinical Practice Guidelines

參考文獻

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