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