超頻音波拉皮燙傷案：醫材之仿單外使用【學習式判解評析】 試閱
Burn by High-intensity Focused Ultrasound for Facelift：The Off-Label Use of Medical Device
本件為使用超頻音波治療儀拉皮後發生灼燙傷事件，病人主張醫師不具有儀器仿單上所載之操作資格，且拉皮部位超出仿單所載之適應症範圍，而醫師並未告知前情，再者施作過程亦有過失。二審級法院均為病人敗訴之判決。本文擇仿單記載外之使用為評析主軸，探究醫療行為違反仿單記載事項之法評價。
The plaintiff suffered from burn injury after high intensity focused ultrasound for facelift performed by the defendant, and claimed for damages for malpractice due to unqualified, off-label use of this ultrasound device and violation of informed consent doctrine. The courts found for the defendant. This article comments on jurisdiction reasoning with special emphasis on the liability of the off-label use of medical devices.
068-092
