Drug Maker Found Liable Despite Fda Warning Label

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Drug Maker Found Liable Despite Fda Warning Label

机译：尽管有Fda警告标签，但制药商仍应承担责任

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Drug makers can be held liable for harm caused by their medicines, even if the drugs already carry federally approved warning labels, the US Supreme Court ruled on 4 March. The high court majority said that Diana Levine was entitled to a US$6.7-million award a state jury gave her, after she sued drug maker Wyeth of New Jersey. A musician from Vermont, Levine had a Wyeth anti-nausea drug mistakenly injected into an artery, even though a label, approved by the US Food and Drug Administration (FDA), warned against such practice. Gangrene set in, and Levine's forearm was amputated.

机译：美国最高法院在3月4日裁定，即使药物已经带有联邦批准的警告标签，药物制造商也可能要对其药物造成的损害负责。高等法院多数人表示，戴安娜·莱文（Diana Levine）起诉新泽西州的制药商惠氏（Wyeth）后，有权获得州陪审团判给她的670万美元的赔偿。 Levine来自佛蒙特州，是一位音乐家，尽管美国食品和药物管理局（FDA）批准了标签，但仍警告将Wyeth抗恶心药物误注入动脉。坏疽进入，Levine的前臂被截肢。

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《Nature》 |2009年第7235期|p.137|共1页
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收录信息美国《科学引文索引》(SCI);美国《工程索引》(EI);美国《生物学医学文摘》(MEDLINE);美国《化学文摘》(CA);
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正文语种 eng
中图分类自然科学总论;
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1. Current FDA-Related Drug Information - Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights July-September 2016 [J] . Teresa Rubio Hospital pharmacy. . 2016,第11期

机译：目前的FDA相关药物信息 - FDA批准的安全标签变更的摘要：盒装警告亮点七月至2016年9月
2. Court Rules Brand-drug Makers Not Liable For Generics' Labeling [J] . Elizabeth Jones Washington Drug Letter . 2009,第12期

机译：法院裁定品牌药制造商对仿制药的标签不承担任何责任
3. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Supplemental Actions Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2011,第9期

机译：当前与FDA有关的药物信息由FDA批准的新药物新剂型和适应症，由FDA代理商批准的待批FDA批准的新药/生物许可申请，由制造商提出的补充措施，由制造商提出的重要措施，或与“亲爱的健康专业人员”的信件有关安全
4. Toward Creating a Gold Standard of Drug Indications from FDA Drug Labels [C] . Khare Ritu, Li Jiao, Lu Zhiyong IEEE International Conference on Healthcare Informatics . 2013

机译：试图通过FDA药品标签创建药品指示金标准
5. Evaluation of three statistical estimation procedures in the assessment of the association between the fda suicidality warning and antiepileptic drug prescription claims in a state medicaid program. [D] . Mittal, Manish. 2013

机译：在州医疗计划中，对fda自杀性警告与抗癫痫药处方要求之间的关联进行评估时，采用三种统计估计程序进行评估。
6. FDA committee votes for warning labels on stimulant drugs [O] . Fred Charatan 2006

机译：FDA委员会对刺激性药物的警告标签进行投票
7. Black Box Warnings and Drug Safety: Examining the Determinants and Timing of FDA Warning Labels [O] . Allan Begosh, John Goldsmith, Ed Hass, 100

机译：黑匣子警告和药物安全：检查FDa警告标签的决定因素和时间
8. Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-Label Uses [R] . 2008

机译：处方药：FDa对标签外用药的促销监督

Drug Maker Found Liable Despite Fda Warning Label

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