April 4, 2013
The Supreme Court on April 2 decided to reject plaintiffs’ appeal against the Tokyo High Court ruling absolving the government from its responsibility to compensate for damages caused by the anti-lung cancer drug Iressa.
Meanwhile, the top court accepted an appeal from plaintiffs seeking compensation from the drug distributer, AstraZeneca.
The lawsuit was filed in 2004 by the bereaved families of two cancer patients who died from Iressa-induced side effects.
In the court battle, they argued that AstraZeneca failed to fulfill its legal responsibility to provide to medical institutions a proper warning regarding a fatal side effect, interstitial lung disease, when Iressa obtained government approval for the sale of the drug in July 2002. The plaintiffs also demanded state compensation on the grounds that the state issued no warnings to the company regarding the drug’s distribution although Iressa-caused deaths had already been documented.
The Tokyo District Court in March 2011 acknowledged AstraZeneca’s failure to fulfill its requirement to state a warning against such a severe side effect under the Product Liability Act and ordered the company to pay compensation. The court also ruled that the government should accept liability for drug-induced damages because it failed to issue warnings to the company despite having recognized the damages.
The Tokyo High Court, however, overturned the lower court ruling stating that cancer doctors must have known about Iressa’s side effects without anyone having to tell them the risk.
In 2002, the Japanese government approved Iressa for treating lung cancer, the first in the world to do so. Before gaining approval, AstraZeneca had advertised the drug as a “dream come true medicine” with minimum side effects, which attracted much attention from both patients and doctors. However, 200 people died from the drug’s side effects, including interstitial lung disease, within six months after the drug came to market.
Related past articles:
> State fails to secure safety of Iressa drug: Court finding [March 24, 2011]
> Court rejects compensation claim from ‘Iressa’ victims [November 16, 2011]
Meanwhile, the top court accepted an appeal from plaintiffs seeking compensation from the drug distributer, AstraZeneca.
The lawsuit was filed in 2004 by the bereaved families of two cancer patients who died from Iressa-induced side effects.
In the court battle, they argued that AstraZeneca failed to fulfill its legal responsibility to provide to medical institutions a proper warning regarding a fatal side effect, interstitial lung disease, when Iressa obtained government approval for the sale of the drug in July 2002. The plaintiffs also demanded state compensation on the grounds that the state issued no warnings to the company regarding the drug’s distribution although Iressa-caused deaths had already been documented.
The Tokyo District Court in March 2011 acknowledged AstraZeneca’s failure to fulfill its requirement to state a warning against such a severe side effect under the Product Liability Act and ordered the company to pay compensation. The court also ruled that the government should accept liability for drug-induced damages because it failed to issue warnings to the company despite having recognized the damages.
The Tokyo High Court, however, overturned the lower court ruling stating that cancer doctors must have known about Iressa’s side effects without anyone having to tell them the risk.
In 2002, the Japanese government approved Iressa for treating lung cancer, the first in the world to do so. Before gaining approval, AstraZeneca had advertised the drug as a “dream come true medicine” with minimum side effects, which attracted much attention from both patients and doctors. However, 200 people died from the drug’s side effects, including interstitial lung disease, within six months after the drug came to market.
Related past articles:
> State fails to secure safety of Iressa drug: Court finding [March 24, 2011]
> Court rejects compensation claim from ‘Iressa’ victims [November 16, 2011]
