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八旬老人试新药休克 拜耳赔偿5万欧元--亲稳舆论引导监测室
2013-02-25

  中新网北京2月21日电(记者 于立霄)84岁的张女士参与拜耳医药公司新药临床试验过程中出现休克等症状,她将拜耳医药保健有限公司、北京大学人民医院告上法庭,索赔15万欧元保险赔偿。21日,北京市朝阳区法院对此案一审宣判,认定拜耳公司承担责任,赔偿张女士5万欧元。

Beijing Beijing on February 21 (Reuters)(Reporter in clouds made)The 84 - year - old ms. Zhang participate in bayer pharmaceutical companies new drug clinical trials appeared in the process of the symptom such as shock,She will bayer medical care co., LTD/The people's hospital of Beijing university to court,A 150000 euro insurance compensation.21,Beijing chaoyang district court in the first sentence,Bayer company that responsibility,Ms. Zhang for 50000 euros.

  张女士诉称,2006年10月17日,她因左膝疼痛入住人民医院进行人工关节置换术。术前,该院医生动员她参加由拜耳医药公司生产的新药BAY59-7939片剂临床试验。她在手术期间服用新药后,出现了无脉搏、呼吸不畅、血压下降等休克症状,经抢救,生命体征恢复。拜耳医药公司事后付她医药费3296.17元人民币。

Ms. Zhang v. says,October 17, 2006,She was left knee pain in people's hospital for artificial joint replacement.preoperative,The hospital doctors to mobilize her by bayer pharmaceutical company production of new drugs BAY59-7939 tablet clinical test.She in the perioperative period after taking drugs,Appear on pulse/Dull breath/Blood pressure decline shock symptoms,After the rescue,Vital signs recovery.Bayer pharmaceutical companies pay for her medical after 3296.17 yuan RMB.

  张女士了解到,拜耳医药公司的上级公司拜耳集团在德国格林工业保险股份有限公司为其境外新药试验投保,该保险为每个受试者的最高保额为50万欧元。事发后,张女士以出现休克属新药试验中的严重不良反应为由,起诉拜耳医药公司,人民医院承担连带责任。

Ms. Zhang to know,Bayer pharmaceutical company superior company bayer group in Germany green industrial insurance co., LTD. For its overseas for new drug test,This insurance for each of the participants' limits for 500000 euros.After the incident,Ms. Zhang to appear shock of the new drug test for serious adverse reactions,Sue bayer pharmaceutical companies,People's hospital shall be jointly and severally liable.

  拜耳医药公司在庭审时辩称,公司委托人民医院试药,但张女士在进行静脉造影的过程中产生休克并非试用新药造成的,而是造影剂过敏,因此不同意赔偿。

Bayer pharmaceutical companies in the trial that when,The company entrusted people's hospital reagent,But ms. Zhang in the vein of the imaging process of shock is not caused by the new trial,But the contrast agent allergy,So don't agree to compensation.

  人民医院则辩称,医院是受拜耳医药公司委托,与张女士发生新药试验关系,医院不应承担赔偿责任,相应责任应由拜耳医药公司承担。

People's hospital is argued,The hospital is affected by bayer pharmaceutical company entrusted,Ms. Zhang happen with new drug test relationship,The hospital shall assume no responsibility or liability to pay compensation,Corresponding responsibility should undertake by bayer pharmaceutical company.

  法院审理查明,张女士参与新药BAY59-7939片剂试验,是德国拜耳集团公司研制开发。德国拜耳集团公司授权拜耳医药公司作为在中国申请该药的国际多中心临床研究的代理机构。2006年3月,拜耳公司与人民医院签订临床试验协议。

The court found,Ms. Zhang to participate in new drug BAY59-7939 tablet test,Germany's bayer group company research and development.German bayer group company authorized bayer pharmaceutical company in China as the application of international multicenter clinical research agencies.In march of 2006,Bayer company and people's hospital clinical trial agreement signed.

  法院审理认为,鉴于拜耳医药公司与人民医院系委托关系,拜耳医药公司应对受试者承担新药试验的责任义务,拜耳医药公司理应向受试者承担相应的经济补偿。

Court think,In view of the bayer pharmaceutical companies and people's hospital is a principal-agent relationship,Bayer pharmaceutical companies to undertake new drug test subjects of duty,Bayer pharmaceutical companies should bear corresponding to the subjects of economic compensation.

  法院还认为,张女士出现的过敏性休克症状,属新药试验过程中的严重不良事件。对此拜耳医药公司作为试验方应予赔偿。最终,法院判决拜耳医药公司赔偿原告5万欧元。(完)

The court also believe that,Ms. Zhang appear anaphylactic shock symptoms,In the process of new drug test of serious adverse events.This bayer pharmaceutical company as a test party shall compensate.finally,Court bayer pharmaceutical company to compensate for the plaintiff 50000 euros.(finish)


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