Japan High Court rules in favor of AstraZeneca over Iressa deaths

Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) Japanese subsidiary has received a decision from the Osaka High Court of Appeals in response to their appeal against the decision made by the Osaka District Court on 25 February 2011 regarding a law suit naming AstraZeneca and the Ministry of Health, Labor and Welfare (MHLW) as defendants, brought by (i) the bereaved families of three patients and (ii) one surviving patient,-claiming damages for the patients who suffered interstitial lung disease (ILD) side effects and, with the exception of the surviving patient, death following treatment with the company’s lung cancer drug Iressa (gefitinib).

An AstraZeneca spokesman told The Pharma Letter that the court decision not only affirmed the efficacy and usefulness of Iressa already acknowledged by the original ruling by Osaka District Court but also judged that there were no defects with respect to the safety warning regarding interstitial pneumonia.

“AstraZeneca KK [Japan] will evaluate the details of the ruling to determine next steps. We have consistently and appropriately been informing physicians about the risk/benefit profile of Iressa and the role it plays in the treatment of this deadly disease since its launch,” the spokesman said.