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題名：論處方藥標示外使用之民事侵權責任
書刊名：東吳法律學報
作者：吳淑莉 引用關係
作者(外文)：Wu, Shu-li
出版日期：2012
卷期：23:4
頁次：頁125-157
主題關鍵詞：處方藥標示外使用；商品製造人責任；指示或警告上瑕疵；醫療過失；注意義務；告知後同意法則；Off-label uses of prescription drugs；Manufacturers' products liability；Inadequate instructions or warnings；Medical negligence；Due care；Informed consent doctrine
原始連結：連回原系統網址new window
相關次數：
  • 被引用次數被引用次數:期刊(3) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:3
  • 共同引用共同引用:117
  • 點閱點閱:106
處方藥標示外使用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，以開立標示外使用之處方，則病患可獲得治療利益，但關於「處方藥標示外使用」之安全性，提供處方藥流通於市面之藥品製造商及開立標示外使用處方之醫師，均有其應盡之義務及責任。因此，本文從民事侵權責任之觀點，探討處方藥標示外使用之消保法商品製造人責任，即醫師之處方藥標示外使用行為，對藥品製造商瑕疵責任之認定有無影響。另進一步探討處方藥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。最後，探究醫師之告知同意範圍是否涵蓋其特定用藥之性質上屬標示外使用行為，且醫師之告知同意內容是否因標示外使用行為，而應有所改變。
Off-label prescription of drugs occurs when a doctor prescribes a drug in any manner that varies from labeling specifications, which are limited to FDA-approved uses. Off-label prescribing of drugs is a common and significant part of current medical practice. In addition to being accepted medical practice, off-label prescribing of drugs often can help patients with optimal care as long as doctors prescribe them with due care. Under the right circumstances, off-label prescribing is often appropriate, but it also creates special risks that are not present when the prescribing is on-label uses. Therefore, drug manufacturers and prescribing doctors should take on the civil liabilities in tort for injuries caused by off-label drug uses in order to achieve the safety and efficacy of off-label uses of prescription drugs.First, this Article analyzes the manufacturers' product liability of drug manufacturers under Taiwan Consumer Act for injuries stemming from off-label uses of prescription drugs. It examines the issues on whether off-label prescribing of drugs affects the determination of manufacturing, design, and warning defects. Further, this Article examines whether off-label prescribing of drugs is negligence per se and thus prescribing doctors are liable for medical malpractice. Finally, this Article examines whether the tort doctrine of informed consent should be expanded to require doctors to disclose off-label prescriptions, and whether the contents of it should be extended with regard to the act of off-label prescribing of drugs.
期刊論文
1.Owen, David G.(2010)。Dangers in Prescription Drugs : Filling A Private Law Gap in the Healthcare Debate。CONN. L. REV，42，733。  new window
2.楊秀儀(20070600)。論病人自主權--我國法上「告知後同意」之請求權基礎探討。國立臺灣大學法學論叢，36(2)，229-268。new window  延伸查詢new window
3.陳聰富(20090100)。醫療侵權之歸責原則。月旦法學教室，75，81-92。  延伸查詢new window
4.曾育裕(20050800)。醫療事故民事責任之演進與發展。東吳法律學報，17(1)，115-150。new window  延伸查詢new window
5.侯英泠(20080600)。醫療機構、外科醫師與麻醉科醫師之說明義務--最高法院九六年臺上字第二四七六號判決簡評。臺灣法學雜誌，107，291-297。  延伸查詢new window
6.陳忠五(20051100)。產前遺傳診斷失誤的損害賠償責任--從「新光醫院唐氏症事件」論我國民事責任法的新課題。國立臺灣大學法學論叢，34(6)，107-260。new window  延伸查詢new window
7.楊秀儀(20021000)。論醫療糾紛之定義、成因及歸責原則。臺灣本土法學雜誌，39，121-131。  延伸查詢new window
8.陳聰富(20090800)。告知後同意與醫師說明義務。月旦法學教室，82，66-80。  延伸查詢new window
9.陳聰富(20040700)。論侵權行為法上之過失概念--最高法院九十年度臺上字第一六八二號民事判決評釋。國立臺灣大學法學論叢，33(4)，145-204。new window  延伸查詢new window
10.汪紹銘(2007)。藥品仿單外之使用(Off-Label Use)之法律問題。全國律師，11(12)，73-81。  延伸查詢new window
11.曾品傑(2010)。我國醫療民事責任之實務發展－兼論法國法對於我國實務之啟發。國立中正大學法學集刊，29，69-135。new window  延伸查詢new window
12.Ausness, Richard C.(2008)。“There’s Danger Here, Cherie!”: Liability for the Promotion and Marketing of Drugs and Medical Devices for Off-Label Uses。BROOK. L. REV.，73，1253。  new window
13.Atwell, Barbara L.(2006)。The Modern Age of Informed Consent。U. RICH. L. REV.，40，591。  new window
14.Beck, James M.、Azari, Elizabeth D.(1998)。FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions。FOOD & DRUG L.J.，53，71。  new window
15.Coutinho, Santosh V.(2009)。License to Promote, or Just What the Doctor Ordered? the New FDA Guidance on Dissemination of Off-label Reprints by Pharmaceutical Companies。TEMP. J. SCI. TECH. & ENVTL. L.，28，279。  new window
16.Girod, Jennifer(2007)。The Learned Intermediary Doctrine: An Efficient Protection for Patients, Past and Present。IND. L. REV.，40，397。  new window
17.Grant, Jonathan E.(1988)。The “Misuse” Defense in Drug Products Liability Cases。PACE L. REV.，8，535。  new window
18.Johns, Margaret Z.(2007)。Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest。HASTINGS L.J.，58，967。  new window
19.Ketler, Suzanne K.(2001)。The Rebirth of Informed Consent: A Cultural Analysis of the Informed Consent Doctrine After Schreiber v. Physicians Insurance Co. of Wisconsin。NW. U. L. REV.，95，1029。  new window
20.Kurtz, Sheldon F.(2000)。The Law of Informed Consent: From “Doctor Is Right” to “Patient has Rights”。SYRACUSE L. REV.，50，1243。  new window
21.Miller, Kate(2005)。Hormone Replacement Therapy in the Wake of the Women's Health Initiative Study: An Opportunity to Reexamine the Learned Intermediary Doctrine。WM. & MARY J. WOMEN & L.，12，239。  new window
22.Noah, Lars(2009)。Symposium: The Products Liability Restatement: Was It a Success? This Is Your Products Liability Restatement Drugs。BROOK. L. REV，74，839。  new window
23.Osborn, John E.(2010)。Can I Tell You the Truth? A Comparative Perspective on Regulating Offlabel Scientific and Medical Information。YALE J. HEALTH POL’Y, L. & ETHICS，10，299。  new window
24.Owen, David G.(2000)。Products Liability: User Misconduct Defenses。S.C. L. REV.，52，1。  new window
25.Salbu, Steven R.(1999)。Off-Label Use, Prescription, and Marketing of FDA-Approved Drugs: An Assessment of Legislative and Regulatory Policy。FLA. L. REV.，51，181。  new window
26.Shifton, Mark D.(2002)。The Restatement (Third) of Torts: Products Liability-The Ali's Cure for Prescription Drug Design Liability。FORDHAM URB. L.J.，29，2343。  new window
27.Stoffelmayr, Kaspar J.(1996)。Products Liability and “Off-Label” Uses of Prescription Drugs。U. CHI. L. REV.，63，275。  new window
28.Studer, Martin R.(1987)。The Doctrine of Informed Consent: Protecting the Patient’s Right to Make Informed Health Care Decisions。MONT. L. REV.，48，85。  new window
學位論文
1.陳俞潓(1999)。台北地區醫學中心醫師對藥品核准標示外使用的認知、態度與使用概況(碩士論文)。國立臺灣大學。  延伸查詢new window
2.林恩萱(2005)。Carbamazepine藥品核准標示外使用 (Off-LabelUse) 之研究(碩士論文)。國立陽明大學。  延伸查詢new window
3.宋家桾(2007)。藥品標示外使用之定性與損害責任研究。國立清華大學。  延伸查詢new window
4.林俊農(2010)。藥物標示外使用之法律問題研究。國立高雄第一科技大學。  延伸查詢new window
5.許杏如(2009)。藥品仿單標示外使用(Off-Label Use)之民事責任與藥害填補。國立成功大學。  延伸查詢new window
6.黃崇呈(2006)。使用仿單核准適應症外處方之責任。國立清華大學。  延伸查詢new window
圖書
1.Owen, David G.、Montgomery John E.、Davis, Mary J.(2007)。Products Liability and Safety : Cases and Materials。New York, NY：Foundation Press。  new window
2.林益山(2008)。消費者保護法。臺北：五南圖書出版股份有限公司。  延伸查詢new window
3.王澤鑑(2009)。侵權行為法。王澤鑑。  延伸查詢new window
4.吳志正(2006)。醫療契約篇—解讀醫病關係。台北。new window  延伸查詢new window
5.NOAH, LARS(2007)。LAW, MEDICINE, AND MEDICAL TECHNOLOGY: CASES AND MATERIALS。  new window
 
 
 
 
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