Saturday, February 26, 2011

AstraZeneca ordered to pay damages over side effects of Iressa drug › Japan Today: Japan News and Discussion

AstraZeneca ordered to pay damages over side effects of Iressa drug › Japan Today: Japan News and Discussion: "OSAKA —

The Osaka District Court on Friday ordered the Japan unit of British drugmaker AstraZeneca PLC to pay a total of 60.5 million yen to nine out of 11 plaintiffs who demanded compensation over side effects caused by the lung cancer drug Iressa.

The three-judge panel, however, turned down the plaintiffs’ demand that the Japanese government pay the damages jointly with Osaka-based AstraZeneca KK, which is 80% owned by its British parent and the remaining 20% by Sumitomo Chemical Co.

The 11 plaintiffs had sought a total of 104.5 million yen in damages from the government and AstraZeneca.

In Friday’s decision, Presiding Judge Fumikiyo Takahashi said AstraZeneca failed to include sufficient explanations in the package insert about the side effects of the Iressa drug at the time of its approval.

The court acknowledged the drugmaker’s liability to compensate patients who took the drug through Oct 15, 2002, when it issued an urgent safety advisory urging medical institutions to tell patients about the risks from the drug’s side effects.

Japan was the first country to import the Iressa drug, which was developed by AstraZeneca, allowing it to put the drug on the Japanese market in July 2002.

On Friday’s ruling, Health, Labor and Welfare Minister Ritsuo Hosokawa issued a statement welcoming the court decision, saying he believes the government’s arguments were accepted.

Hosokawa also said the government will speed up studies on a relief scheme for sufferers of side effects caused by anticancer drugs.

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