論醫療器材標示外使用之侵權責任【本期企劃】 試閱
A Study on Tort Liability for Off-Label Use of Medical Device
「醫療器材標示外使用」係為通常且重要之醫療實務，而若醫師善盡其醫療之注意義務，為標示外使用之醫療行為，則病人可獲得治療利益，但關於標示外使用之安全性，標示外使用醫療器材之醫師及提供醫療器材流通於市面之醫療器材商，均有其應盡之義務及責任。因此，本文從侵權責任之觀點，醫療器材之標示外使用是否即為醫師注意義務之違反，而應對病患負擔過失侵權之損害賠償責任，並探討醫療器材標示外使用對消保法商品無過失責任有無影響。
Off-label use of medical device is a common and significant part of current medical practice. Under the right circumstances, off-label use of medical device is often appropriate, but it also creates special risks that are not present when the use is on-label. Therefore, this Article examines whether medical device off-label use is negligence per se and thus doctors are liable for medical malpractice. Further, it analyzes the product liability of medical device manufacturers under Taiwan Consumer Act for injuries stemming from off-label uses of medical devices. It examines the issues on whether off-label use of medical device affects the determination of manufacturing, design, and warning defects.
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