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Top court backs rulings absolving drugmaker’s Japan agent over deaths laid to Iressa

Kyodo

The Supreme Court on Friday upheld high court rulings that the Japanese unit of British drugmaker AstraZeneca PLC bore no liability over fatal side effects caused by the lung cancer drug Iressa.

The top court thus turned down appeals from relatives of patients who died from side effects of the drug. It previously did not accept appeals against lower court rulings absolving the central government of liability over the deaths.

The Tokyo High Court in November 2011 and the Osaka High Court last May both turned down the plaintiffs’ demand for damages, both ruling that the government and AstraZeneca K.K., the Japanese unit of AstraZeneca PLC, were not liable for the patients’ deaths.

The focal point of the cases was whether the government and AstraZeneca provided sufficient guidance to medical staff and users about the risk of interstitial pneumonia, a side effect of Iressa, which was approved by the health ministry in July 2002 as a cancer drug.

Health ministry data show 862 patients given Iressa had died from interstitial pneumonia by the end of last year.

In March 2011, the Tokyo District Court ordered AstraZeneca K.K., the importer and seller of Iressa, and the government to pay a combined ¥17.6 million to two of the four plaintiffs, who are relatives of three patients who died due to the drug’s side effects.

The Tokyo High Court overturned the lower court ruling eight months later, finding that the government and AstraZeneca were not responsible and turning down the plaintiffs’ demand for a combined ¥77 million in damages.

In February 2011, the Osaka District Court ordered AstraZeneca to pay a total of ¥60.5 million to nine out of 11 plaintiffs who demanded compensation over similar side effects.

But the Osaka High Court found that both the government and AstraZeneca were not responsible in its May 2012 ruling, which turned down the 11 plaintiffs’ demand for a combined ¥104.5 million in damages.