The Osaka District Court on Thursday marked a historic and welcome first for this country. Three former presidents of the defunct Osaka-based pharmaceutical company Green Cross Corp. were found guilty of professional negligence and sentenced to prison in the case of a hospital patient who died of AIDS-related complications nine years after being infected by an HIV-tainted blood product manufactured and distributed by the company. The ruling handed down by Mr. Mikio Kiyoshi, the presiding judge, was the first time a Japanese judicial authority had held a pharmaceutical company criminally responsible for death or injury resulting from use of one of its products.

Unsuspended prison sentences for criminal defendants who once held such senior executive posts are rare in Japan and testify to the severity with which the judge viewed the company’s continued manufacture and distribution of unheated blood products in 1986, despite the fact that safer heat-treated products had become available and the link between unheated products and possible HIV infection was already known. Green Cross also failed to take any steps to recall the unheated products from the market, even placing advertisements that falsely claimed all its blood products were safe.

The longest of the three sentences handed down is for only two years — entirely too short in the view of many observers, and especially so to relatives of some of the victims of the defunct company’s misguided policy of putting market share and profits above the threat to the lives of hemophiliacs and others whose health depended on the safety of their products. The best defense the high-priced legal team representing the former executives apparently could muster was to try to shift the blame for the tragedy to the Health and Welfare Ministry, since it did not instruct the company to recall the unheated products, and to the hospital that treated the patient for its continued use of such products. The court’s ruling is a warning against such tactics.

There is plenty of blame to share in this tragedy. The health ministry is indeed culpable for having failed to deal correctly and in timely fashion with the threat of HIV infection from tainted blood products. One ministry official directly involved is now on trial at the Tokyo District Court for his role in the scandal, as is the specialist doctor and former vice president of Teikyo University, who as a senior adviser to the ministry allegedly minimized the HIV risk until it was too late. That in no way absolves the former Green Cross officials, who as the Osaka District Court ruling pointed out, were in a position to have the most up-to-date scientific data on HIV-AIDS from their subsidiary in the United States. In fact, one of the defendants warned of the possible HIV risk from unheated blood products as early as 1983, only to do a complete about-face a few months later.

Another defendant in the case was among the Green Cross executives who bowed and prostrated themselves in front of a group of HIV-infected plaintiffs before their claims were settled in 1996. The third defendant had once served as a director of the pharmaceutical affairs bureau at the Health and Welfare Ministry. As expected, attorneys for the three former executives immediately filed appeals for their clients with the Osaka High Court, and all three are now free on bail. However, they have not and should not escape condemnation for the public-health tragedy they helped to cause, even though at the time many in senior corporate and bureaucratic positions in this country mistakenly believed HIV-AIDS not to be a mainstream health issue.

They now know better, as does society in general, although not well enough, it seems. According to the health ministry’s own figures, more than 2,000 Japanese hemophiliacs and more than 300 patients under treatment for other illnesses became HIV-positive as a result of being administered unheated blood products and over 500 of them have since died of AIDS-related complications. Those who have not developed full-blown AIDS nevertheless face bleak and uncertain futures. Many are still relatively young yet have virtually no opportunity for employment or marriage and face continuing social prejudice and even ostracism. That is the lasting legacy of the triple failure of the health bureaucracy, the medical establishment and the pharmaceutical industry to face up to the challenge that tainted, unheated blood products presented.

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