The government on Jan. 28 rejected a recommendation by the district courts in Tokyo and Osaka for a negotiated settlement of lawsuits over the side-effects caused by the lung cancer drug Iressa. The government's rejection followed the rejection four days earlier by AstraZeneca K.K., an Osaka-based Japanese subsidiary of British drugmaker AstraZeneca PLC, which developed and manufactured the drug. The government believes that the recommendation contains provisions that would lead to the restriction of clinical trials and delay the approval process of cancer drugs.
On Jan. 12, the 15 plaintiffs accepted the courts' Jan. 7 recommendation. The plaintiffs consist of a surviving patient who has suffered a side-effect from the drug and bereaved family members of six patients who died after using the drug. The rejection by the government and the company will only delay the relief for the plaintiffs. More than six years have passed since the plaintiffs filed the lawsuits in 2004. The lawsuits are the first over serious side-effects caused by a cancer drug.
The content of the court recommendation shows that the courts are likely to rule in favor of five of the seven patients involved in the lawsuits. The Osaka District Court will hand down a ruling on Feb. 25 and the Tokyo District Court on March 23. The lawsuit process will be prolonged because the government and the company will very likely appeal the rulings.