篇名

「日本製造物責任法」事例:抗癌劑輸入商因藥物副作用造成病人死亡,是否有說明書記載缺陷的問題?   免費試閱

並列篇名

A Case of Product Liability Act In Japan: Should Anticancer agents Importer Be Blamed For The Deaths of Patients Due To Incomplete Medication Instructions?

作者
中文摘要

兩名肺癌末期患者在服用被告製藥商於2002年7月經厚生勞動省輸入核可的抗癌劑「Iressa艾瑞莎250錠」後,引發間質性肺炎死亡。身為家屬的原告們認為被告並未在藥物說明書之副作用欄標注「致死」危險,有記載不詳之嫌,按製造物責任法之「製造物缺陷」責任,對被告提起損害賠償之訴。

東京高等法院以下述等理由取消一審的判決結果,否定製藥商與國家(厚生勞動省)有責任:

(1)若有相當危險性的藥物,在其具備之藥效屬於必須的情況下,潛在著發生重大副作用的可能性不能被認定為該藥品之「缺陷」,(2)本抗癌劑主要使用者為醫師,一般醫師對抗癌劑與間質性肺炎的副作用之間的關係應有所了解,(3)參考當時日本國內外的案例,也僅能認定本藥可能導致與其他抗癌劑「相同程度」之副作用,無法預見Iressa艾瑞莎導致特殊、急性致死的狀況,亦無法認定該死亡與抗癌劑間的因果關係。

英文摘要

Two patients with terminal lung cancer died of interstitial pneumonia after taking the anticancer drug "IRESSA Film-Coated Tablets 250 mg". This drug was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan, and was imported in July 2002 by a drug manufacture, the defendant in this case. The plaintiffs, who were the family members of the dead, considered that the defendant did not indicate the "death risk “ in the side-effects column of medication instructions, so the defendant was liable for it’s" defective product” in accordance with the Product Liability Act.

The Tokyo High Court decided to cancel the judgment of the first trial, disagreeing over the liability of the drug manufacturer and the government (MHLW) according to below reasons:

(1) If the side effect of this drug is an inseparable part of it’s efficacy, the drug may not be identified as "defective".

(2) The main users of IRESSA are doctors, who should be aware of the interstitial pneumonia side effect.

(3) By looking through cases from Japan and other countries at that time, it showed no significant differences of potential side effects between IRESSA and other anticancer agents. IRESSA is not expected to lead to any special or acute fatal consequences. Therefore, the relation between IRESSA and the deaths of patients cannot be determined.

起訖頁

143-149

出版單位
DOI

10.3966/241553062016070001012  複製DOI  DOI查詢

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