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Medicolegal Review: Perinatal Effexor Lawsuits and Legal Strategies Adverse to Prescribing Obstetric Providers

机译:法医评论:围产期药效官司和法律策略不利于处方产科医师

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摘要

>Objectives  This study was aimed to familiarize obstetricians with the legal environment surrounding Effexor lawsuits and emphasize the importance of documenting informed consent in the medical records when prescribing a medication that is being targeted for litigation. >Study Design  We used the LexisNexis legal search engine to review legal documents from Effexor-related cases and also used Google to search for Effexor-related lawsuits online, further researching these cases via publically available court records from district clerk offices. Finally, we conducted a year-by-year literature review from 1993 to 2017 to establish the history and evolution of scientific studies surrounding Effexor use during pregnancy. >Results  Litigation involving Effexor typically arises due to congenital cardiac birth defects in the neonate allegedly associated with maternal Effexor use in pregnancy. Medication manufacturers have employed a legal strategy termed the learned intermediary doctrine in an attempt to shift liability away from themselves and on to prescribing obstetricians. Manufacturers claim they adequately inform obstetricians of the risks and benefits of prescribing their product and it is the duty of the obstetrician to relay those risks and benefits to their patients. >Conclusion  To reduce the risk of liability exposure, obstetricians must adequately document informed consent in the medical records when prescribing medications to their pregnant patients.
机译:>目标这项研究旨在使产科医生熟悉围绕Effexor诉讼的法律环境,并强调在开具针对诉讼的药物时,在病历中记录知情同意的重要性。 >研究设计我们使用LexisNexis法律搜索引擎来审查与Effexor有关的案件的法律文件,还使用Google在网上搜索与Effexor有关的诉讼,并通过地方书记员公开提供的法院记录进一步研究这些案件办公室。最后,我们从1993年至2017年逐年进行了文献综述,以建立有关孕期使用Effexor的科学研究的历史和演变。 >结果 involving涉及Effexor的诉讼通常是由于据称与孕妇使用Effexor有关的新生儿先天性心脏出生缺陷而引起的。药品生产商采用了一种称为“博学的中介理论”的法律策略,试图将责任从自己身上转移到开处方产科医生。制造商声称,他们将处方药的风险和益处充分告知了产科医生,而产科医生有责任将这些风险和益处告知患者。 >结论为降低承担责任的风险,妇产科医生在为其怀孕患者开药时,必须在医疗记录中充分记录知情同意。

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