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  • 學位論文

論醫療器材致人損害之民事責任——以缺陷判斷標準與歸責原則為中心

Civil Liability for Damage Caused by Medical Devices Focusing on Criteria for Judging Defects and the Principle of Attribution

指導教授 : 陳聰富

摘要


在全球各國紛紛進入高齡社會之背景下,醫療器材應用日趨廣泛,越來越多病患受益於醫療器材之研發與革新。但與此同時,病患在臨床上所使用的醫療器材卻無法保證其正常或絕對安全,醫療器材缺陷而引發的不良事件層出不窮。然回歸醫療器材之本質,其本應為減緩病痛、維持生命之重要工具。有鑑於此,對於醫療器材須進行更加嚴格之法律監管與責任規範,始得避免損害事件發生。 本文重新檢視各國醫療器材之監管規範,通過梳理臺灣、中國大陸、美國與歐盟之醫療器材監管法規沿革,比較各國醫療器材在分級管理、審查標準以及輸入醫療器材審查制度之異同,透過比較法進一步理清臺灣醫療器材上市前審查之商業模式與監管制度之漏洞。在此基礎上,探討各國在法律規範與司法實務中所採的醫療器材缺陷判斷標準,並分析各國採不同判斷標準背後之社會原因。同時,本文就強制性標準與不合理危險標準兩種理論,指出強制性標準存在滯後性與片面性之弊端,強調應以不合理危險標準作為醫療器材之缺陷判斷依據更為恰當,以期建立更加明確一致之醫療器材缺陷判斷標準。 本文進一步就醫療器材之相關民事責任,包括醫療機構之契約責任與侵權責任,以及醫療器材製造商對醫療機構之契約責任,和對病患之侵權責任進行比較法分析。其中,透過整理比較各國關於醫療器材損害責任之歸責原則,理清各國法下醫療器材損害責任之框架。最後,本文在結合責任主體特性之基礎上,以比較法之責任規範為臺灣借鏡,綜合與臺灣相應之歸責原則進行比較,進而探討臺灣法下採過失推定原則之合理性,以探求更合理妥適之嚴格責任規範,以期為臺灣醫療器材損害責任體系貢獻相當之實益。

並列摘要


As countries around the world approach toward the aging society, the application of medical devices is increasingly extensive, and more and more patients are benefiting from the research, development and innovations of medical devices. But at the same time, it is difficult to guarantee soundness or absolute safety of the medical equipment used by patients in clinical practice, and the adverse events caused by the defect of medical equipment emerge endlessly. However, the essence of applying medical equipment should be relieving pain and maintaining life. Accordingly, the legal supervision and distribution of responsibility regarding medical equipment should be stricter, so as to avoid the occurrence of damage. This thesis reviews the legislation of medical devices, by analyzing the regulatory evolution about medical device of Taiwan, mainland China, the United States and the European Union. In order to clarify pre-market review system of business model and loopholes of regulation regarding medical device in Taiwan, this thesis use comparative method for further research, and compare the hierarchical managements, review standards and the examination systems for the import of medical equipment from different countries. On the basis of this, we discuss the criteria to determine defects of medical devices adopted by various countries in legislation and practice, and analyzes the social reasons behind the adoption of different criteria. At the same time, this thesis introduces the mandatory standard and unreasonable risk standard, and points out the disadvantages of the mandatory standard. Therefore, it is more appropriate to take unreasonable risk standard as the basis for the criteria to determine defects of medical devices, so as to establish more consistent and clearer criteria. This thesis makes a comparative analysis on the civil liability of medical devices, including contractual liability and tort liability of medical institutions, contractual liability of medical device manufacturers toward medical institutions, and tort liability toward patients. Among above, the framework of medical devices damage liability under different legislation is clarified, through sorting out and comparing the distribution of liability for medical devices damage in different countries. Finally, the comparative legal study of the distribution of liability can act as a reference for Taiwan, by combining with the characteristics of subjects of liability. To explore a more appropriate strict liability, we discuss the rationality of constructive liability for negligence in Taiwan, so as to improve the liability system of medical device damage in Taiwan.

參考文獻


中文文獻
一、專書
王澤鑑(1998),《侵權行為法第一冊:基本理論、一般侵權行為》,自版。
王澤鑑(2015),《侵權行為法》,自版。
王澤鑑(2009),〈商品製造者責任與純粹經濟上損失〉,收於:《民法學說與判例研究(第八冊)》,北京:北京大學出版社。

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