Case 2005 (A) 947

This case concerned whether the accused, the Director of the Biologics and Antibiotics Division of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare, could be held criminally negligent after a patient was given unheated blood products contaminated with HIV and later died of AIDS.

The victim was a hemophiliac patient at Osaka Medical College Hospital in April  1986, during which time he was given three bottles of an unheated blood product after he underwent surgery. The victim then became infected with HIV, contracted AIDS around September 1993, and died at the same hospital in December 1995.

As Director of the Biologics and Antibiotics Division, the accused was responsible for assuring the safety of blood and other biological products and protecting the public from the dangers arising from these products. In Japanese medical institutions, hemophiliac patients were given unheated blood products made in foreign countries that were then imported with the approval of the Minister of Health and Welfare. After scientific study, researchers found that many hemophiliac patients contracted AIDS due to the use of unheated blood products. Following this research as well as recommendations from global health organizations, the Ministry of Health and Welfare recommended that unheated blood products not be used. The accused had recommended in his official capacity that approval for heated blood products be completed quickly. By January 1986, heated blood products were widely available for sale.

The Court convicted the accused under Articles 414 and 386 of the Code of Criminal Procedure. The Court held that the accused was guilty of the crime of causing death through negligence in the pursuit of social activities because it was foreseeable that the use of products contaminated with HIV would cause patients to get infected and likely die.

The Court also held that the accused had a duty of care under criminal law because his position centrally involved protecting the public from drug-induced hazards and taking countermeasures against the dangers posed by these unheated blood products. The unheated blood products were under the scope of products subject to the Biologics and Antibiotics Division where the accused was the director. The accused thus had the duty to take necessary and sufficient measures such as requesting the Ministry of Health and Welfare to discontinue the sale and use of these products in order to prevent HIV infection. The Court also found that the risk of these unheated products had not been shared with doctors, and this lack of clear policy from the state had resulted in the continued use of these dangerous products.

“The Unheated Products, which were widely used at the time of the incident, contained a considerable amount of products contaminated with HIV, and although there remained medically unexplained mysteries, it was foreseeable, as an almost inevitable result, that the use of these products would actually cause the patients to become infected with HIV and develop AIDS.” Page 11.

“A duty of care under criminal law, which is required to be fulfilled in social life by a person engaged in the service for preventing drug-induced hazards, should be imposed upon the person in charge of pharmaceutical administration with regard to the manufacture, use and safety of the Unheated Products. Preventive measures required under the aforementioned circumstances include not only compulsory supervisory measures provided in law; if it can be reasonability expected that the purpose of prevention of hazards can be achieved by taking other measures such as encouraging voluntary actions, such measures can also be regarded as preventive measures, irrespective of whether or not we call them administrative guidance. In the present case, such measures are supposed to be taken against pharmaceutical companies, etc. that are subject to the power of supervision of the Minister of Health and Welfare, and they can also be deemed as reasonable preventive measures.” Page 12.

“It is obvious that the accused had the duty to take necessary and sufficient measures in pharmaceutical administration, including consulting with other bureaus and divisions of the ministry when necessary and encouraging the parties concerned to take actions as required.” Page 13.