OSAKA – The family of a 69-year-old man from Kyoto Prefecture who died in October 2002 filed a lawsuit Thursday with the Osaka District Court against the state and the distributor of lung-cancer drug Iressa for allegedly failing to inform doctors of the drug’s serious side effects.
The man’s wife and children are seeking 33 million yen in damages from the state, which approved the drug’s import, and AstraZeneca K.K., the Japan unit of British pharmaceutical company AstraZeneca PLC, which developed the drug.
It is the first time a lawsuit concerning the side effects of Iressa has been lodged, bringing into question the liability of the state and distributor.
Another family in the city of Saitama also plans to file a similar lawsuit with the Tokyo District Court.
A total of 444 people have died as of March from side effects caused by Iressa, the Health, Labor and Welfare Ministry said.
The drug is also known to dramatically improve the condition of some cancer patients.
“There are people currently fighting cancer by taking Iressa, and we are not intent on seeking to suspend its sale. We just want to shed light on why our relative had to die,” said a family member involved in the Osaka lawsuit.
Japan was the first country to approve import of the drug, whose generic name is Gefitinib, in July 2002, less than six months after the firm applied to the ministry. Sale of the drug began the same month.
According to the lawsuit, the man was diagnosed with lung cancer in the spring of 2002 and was prescribed the drug by his doctor in September of that year.
He soon became ill with interstitial pneumonia and died the following month.
The man’s relatives claim the state did not check whether the drug was safe, such as by reading international reports on its side effects, and that the six-month approval process was too short.
They also blame the distributor for not informing the state about the possible complications that could come from using the drug until after state approval was given, despite its own test trials made prior to application, indicating side effects.
They said the distributor also failed to take steps to help counter side effects, such as warning medical facilities about it.
In June, a group of patients who had taken Iressa approached the firm for compensation but were turned away, which prompted them to take the matter to court.
Martin Wright, president of AstraZeneca K.K., based in Osaka, expressed disappointment that the 69-year-old man’s relatives have filed a suit.
According to Wright, the firm sent a written reply to the family’s request for compensation and explained its position, but they did not reply.
The health ministry has not commented on the case.
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