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論著名稱: 美國法下原開發藥廠與學名藥廠在藥品警告責任的競合及發展(The Concurrent Relationship between Brand Name and Generic Drug Manufacturer’s Duty to Warn under the US Law System)
編著譯者: 李秉燊
出版日期: 2019.11
刊登出處: 台灣/月旦醫事法報告第 37 期 /148-168 頁
頁  數: 13 點閱次數: 166
下載點數: 52 點 銷售明細: 權利金查詢 變更售價
授 權 者: 李秉燊
關 鍵 詞: 產品標示產品警告責任標示警告責任學名藥品
中文摘要: 美國法下,當已知某藥品有潛在危險,卻因製造人未在標示給予適當警告,使消費者使用新藥或學名藥後引起強烈副作用,製造人應負藥品警告責任。然購買新藥者得對原開發藥廠請求賠償,卻因藥事法阻卻學名藥廠產品責任,使得購買學名藥者無法向其提起訴訟。法院得否擴張產品責任範圍,使購買學名藥者轉向原開發藥廠求償?本文從美國藥事法與侵權法規定與法律原則出發,梳理法院判例,分析本議題下美國藥事法和藥品責任的競合與發展。
英文關鍵詞: product labelsthe duty to warmwarning label liabilitygeneric drug
英文摘要: Under US law, the manufacturer bears the duty to warm when a drug is known to be potentially dangerous. Therefore, if the consumer still takes the drug and come with serious side effects because there don’t have any proper warning on the label, the manufacturer should take the responsibility. Under the case law, those who purchase brand name drugs may request compensation from the manufacturer in the aforementioned situation. However, blaming the United States Federal Food, Drug, and Cosmetic Act preempt the product liability of generic drug manufacturer, the person who purchases the generic drug cannot file a lawsuit against the generic drug manufacturer. Could the court expand the scope of product liability so that those who purchase the generic drug can turn to the brand name drug manufacturer for compensation? This article starts from the legal principles and provisions of the US Pharmaceutical Law and Tort Law, sorts out the court’s precedent and jurisprudence, and analyzes the concurrent relationship between the brand name and generic drug manufacturer’s duty to warn under the US Law System.
目  次: 壹、前言
貳、美國藥品警告責任引發之損害賠償請求權議題
一、新藥申請程序與標示法規
二、學名藥上市與標示法規
參、美國產品責任法下藥品警告責任
一、警告瑕疵
二、不實陳述
肆、美國法院對藥品警告責任的判例發展
一、不幸的手?美國聯邦最高法院判例下的藥品警告責任
二、創新者責任?美國各州法院擴張原開發藥廠在藥品警告責任的範圍
(一)加州最高法院引領擴張藥品警告責任範圍
(二)麻州最高法院以未必故意法理擴張原開發藥廠責任範圍
(三)西維吉尼亞最高法院反對創新者責任
三、美國 FDA 立法建議與判決歧異評析
伍、臺灣現狀與美國經驗借鑑
陸、結語
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