November 16, 2011
The Tokyo High Court on November 15 overturned a lower court decision ordering the state and a pharmaceutical firm to pay compensation for deaths caused by a side effect from the anti-lung cancer drug, Iressa.
The lawsuit was filed by bereaved families of three lung cancer patients who died from interstitial lung disease, a serious side effect of Iressa, seeking 77 million yen in compensation from the government and AstraZeneca (Osaka City), the pharmaceutical firm importing the controversial drug.
The biggest issue in the lawsuit is whether the document attached to the drug provided to medical institutions gave sufficient warning against possible lethal side effects.
The court ruling said that the attached document was written for experts in lung cancer treatment and that even though “the document didn’t include a boxed warning or a statement about the possibility that interstitial lung disease induced as a result of Iressa dosages may cause death, it is recognized as reasonable and as not failing to give instructions or warnings.”
The ruling also stated that the state and AstraZeneca are not obliged to take safety measures against diseases reported as possible side effects from Iressa unless a correlation between the drug and the diseases is proven.
Plaintiffs and their lawyers’ group in a statement released on the same day criticized the court’s decision. The statement pointed out, “Lessons from past drug disasters underline the need for the government and medical products companies to implement safety measures based on the precautionary principle. The Pharmaceutical Affairs Act was also created with this point of view in mind.”
The statement concluded, “We will inform the public of the importance of future safety measures for medicines and of the unjust ruling which will lead to future troubles in pharmaceutical administration. We will continue fighting until the Iressa lawsuit achieves a just ruling.”
Iressa caused 180 deaths in six months just after the government approval of the drug in 2002.
The lawsuit was filed by bereaved families of three lung cancer patients who died from interstitial lung disease, a serious side effect of Iressa, seeking 77 million yen in compensation from the government and AstraZeneca (Osaka City), the pharmaceutical firm importing the controversial drug.
The biggest issue in the lawsuit is whether the document attached to the drug provided to medical institutions gave sufficient warning against possible lethal side effects.
The court ruling said that the attached document was written for experts in lung cancer treatment and that even though “the document didn’t include a boxed warning or a statement about the possibility that interstitial lung disease induced as a result of Iressa dosages may cause death, it is recognized as reasonable and as not failing to give instructions or warnings.”
The ruling also stated that the state and AstraZeneca are not obliged to take safety measures against diseases reported as possible side effects from Iressa unless a correlation between the drug and the diseases is proven.
Plaintiffs and their lawyers’ group in a statement released on the same day criticized the court’s decision. The statement pointed out, “Lessons from past drug disasters underline the need for the government and medical products companies to implement safety measures based on the precautionary principle. The Pharmaceutical Affairs Act was also created with this point of view in mind.”
The statement concluded, “We will inform the public of the importance of future safety measures for medicines and of the unjust ruling which will lead to future troubles in pharmaceutical administration. We will continue fighting until the Iressa lawsuit achieves a just ruling.”
Iressa caused 180 deaths in six months just after the government approval of the drug in 2002.
