The Supreme Court on April 12 upheld two high court rulings that said the state and the Japanese unit of British drug maker AstraZeneca PLC bore no liability for fatal side effects caused by the lung cancer drug Iressa.
Lower court rulings had ordered either both AstraZeneca K.K., the Osaka-based importer of the drug, and the state or the company to pay compensation to bereaved families of the dead patients. The trial process shows that judges at various levels of courts made different judgments. But it is important for the government, drug makers and doctors to learn lessons from the lawsuits and consider how to best protect users of newly developed drugs from their side effects.
In February 2011, the Osaka District Court ordered AstraZeneca K.K. to pay some ¥60 million in compensation to 11 family members of four dead patients. As for the responsibility of the state, the ruling said that although its guidance toward the company was not perfect, it was "not irrational," thus deciding that the state has no responsibility for the deaths.