Japan Press Weekly

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2011 March 23 - 29 [WELFARE]

State fails to secure safety of Iressa drug: Court finding

The Tokyo District Court on March 23 ordered the state and a pharmaceutical company to jointly pay a total of 17.6 million yen to two plaintiffs in damages caused by side effect from the lung cancer drug, Iressa.

This ruling was made in a lawsuit filed by bereaved families of Iressa victims seeking compensation from the government and AstraZeneca, the pharmaceutical firm importing Iressa.

The judge said that AstraZeneca did not provide sufficient information about the side effects of Iressa to medical institutions as required by the Product Liability Act, and that the government “failed to give proper instructions to the company to secure the safety of the drug when it approved the sale of Iressa.”

The plaintiffs group and their lawyers stated that the ruling was epoch-making because it acknowledged the government’s responsibility.

In July 2002, the Japanese government approved Iressa as an anti-lung cancer drug after only a five-month examination. However, between July 2002 and September 2010, 819 lung cancer patients taking Iressa died due to a serious side effect, interstitial lung disease.

The March 23 court decision raised a question regarding the medical community’s common assumption that it is inevitable to lose cancer patients’ lives due to anti-cancer drugs’ side effects. Taking this decision as an opportunity for reform, it is necessary for the government to establish a system to relieve victims from damages caused by the anti-cancer drug.

A female plaintiff who lost her father to Iressa-induced damage said, “The court recognized that the government and AstraZeneca should take responsibility for Iressa-induced deaths. I’ll be satisfied if my father’s death contributes to improving cancer treatment.”

Without appealing against the decision, both the state and AstraZeneca should sit down at the negotiation table to work out an immediate and all-out settlement of the lawsuit.