AstraZeneca ordered to pay damages over side effects of Iressa drug

OSAKA, Feb. 25 Kyodo -
The Osaka District Court on Friday ordered the Japan unit of British drugmaker AstraZeneca PLC to pay a total of 60.5 million yen to nine out of 11 plaintiffs who demanded compensation over side effects caused by the lung cancer drug Iressa.
The three-judge panel, however, turned down the plaintiffs' demand that the Japanese government pay the damages jointly with Osaka-based AstraZeneca K.K., which is 80 percent owned by its British parent and the remaining 20 percent by Sumitomo Chemical Co.
The 11 plaintiffs had sought a total of 104.5 million yen in damages from the government and AstraZeneca.
In Friday's decision, Presiding Judge Fumikiyo Takahashi said AstraZeneca failed to include sufficient explanations in the package insert about the side effects of the Iressa drug at the time of its approval.
The court acknowledged the drugmaker's liability to compensate patients who took the drug through Oct. 15, 2002, when it issued an urgent safety advisory urging medical institutions to tell patients about the risks from the drug's side effects.
Japan was the first country to import the Iressa drug, which was developed by AstraZeneca, allowing it to put the drug on the Japanese market in July 2002.
On Friday's ruling, Health, Labor and Welfare Minister Ritsuo Hosokawa issued a statement welcoming the court decision, saying he believes the government's arguments were accepted.
Hosokawa also said the government will speed up studies on a relief scheme for sufferers of side effects caused by anticancer drugs.
Chief Cabinet Secretary Yukio Edano, who is the top government spokesman, told a news conference the government will try to help provide proper treatment for cancer patients, regardless of Friday's court decision.
AstraZeneca said it will consider how to respond to the ruling, including the possibility of appealing to the Osaka High Court.
In January, the Osaka and Tokyo district courts urged both the plaintiffs and defendants to reach a compromise settlement, saying the government and the drugmaker are obliged to help side-effect sufferers and bereaved families.
The proposed settlement plan covered people who died or have suffered side effects as a result of taking the Iressa drug before Oct. 15, 2002.
But the government and AstraZeneca rejected the court proposal, paving the way for the Osaka District Court to give its decision Friday.
The Tokyo District Court, which has been handling a similar damages suit, is scheduled to give its decision March 23.
The focal point of the trial was whether the government and the drugmaker properly made known the risk of interstitial pneumonia, after the damage caused by the drug's side effects became apparent.
The plaintiffs argued that AstraZeneca excessively emphasized the safety of the drug and that the Japanese government was slow to deal with the side effects.
AstraZeneca countered by insisting it had properly presented the danger of side effects and collected information after the drug was approved in Japan. The government argued it acted swiftly in response to side effects.
Sufferers of side effects and their bereaved families filed suits with the Tokyo and Osaka district courts from 2004 to 2005, seeking damages from AstraZeneca and the Japanese government.
More than 800 people have died due to side effects of the drug, while 8,000 to 9,000 people start taking it every year, according to the Health, Labor and Welfare Ministry.
The 11 plaintiffs include only one living patient -- Hideki Shimizu, 55, from Yokkaichi, Mie Prefecture. The others are all bereaved relatives of patients who have already died.
Among other countries, the United States approved the Iressa drug in 2003 but later banned its use in principle after clinical tests showed no survival advantages.
In the European Union, AstraZeneca withdrew its application for approval of Iressa.