February 26, 2011
The Osaka District Court on February 25 ordered a pharmaceutical company to pay about 60 million yen in compensation for drug-induced damages caused by the anti-lung cancer drug, Iressa.
A group of Iressa victims living in Kyoto and Hyogo prefectures had filed a lawsuit against the state and AstraZeneca, the pharmaceutical firm that imported Iressa, claiming that the firm had violated the Product Liability Act.
The ruling stated that AstraZeneca failed to fulfill its legal responsibility for providing proper instructions or warning about possible side effects associated with the use of Iressa, such as interstitial lung disease, when it sold the drug to medical institutions.
Among lawsuits on drug-induced diseases, this is the first court decision which regards drug sales as illegal on the grounds that the drug company offered no appropriate guidance or caution under the relevant law.
The court, on the other hand, avoided pursuing the government’s responsibility in the matter. It stated that the government took reasonable actions to ensure drug safety before and after its approval of the sale.
The plaintiffs group and their lawyers in a statement said that the ruling is historical and significant because it clearly acknowledges that pharmaceutical companies should be required to give explanations about side effects of anti-cancer medicines. However, they criticized the ruling as unjust and inadequate because it refused to hold the government responsible.
A group of Iressa victims living in Kyoto and Hyogo prefectures had filed a lawsuit against the state and AstraZeneca, the pharmaceutical firm that imported Iressa, claiming that the firm had violated the Product Liability Act.
The ruling stated that AstraZeneca failed to fulfill its legal responsibility for providing proper instructions or warning about possible side effects associated with the use of Iressa, such as interstitial lung disease, when it sold the drug to medical institutions.
Among lawsuits on drug-induced diseases, this is the first court decision which regards drug sales as illegal on the grounds that the drug company offered no appropriate guidance or caution under the relevant law.
The court, on the other hand, avoided pursuing the government’s responsibility in the matter. It stated that the government took reasonable actions to ensure drug safety before and after its approval of the sale.
The plaintiffs group and their lawyers in a statement said that the ruling is historical and significant because it clearly acknowledges that pharmaceutical companies should be required to give explanations about side effects of anti-cancer medicines. However, they criticized the ruling as unjust and inadequate because it refused to hold the government responsible.
