Drug-Induced Hepatitis (HCV Infection Through Blood Products)

1. Outbreak and government inaction

In 1964, U.S. Ambassador Edwin O. Reischauer was attacked in Tokyo and, after receiving a blood transfusion, contracted viral hepatitis—an incident that made blood safety a public concern. At the time, Japan’s transfusion blood supply relied heavily on paid donations, prompting the government to decide by Cabinet resolution that all transfusion blood would henceforth come from voluntary donation. By 1974, domestic transfusions relied entirely on donated blood. However, plasma-derived blood fraction products still required pooling from many donors, leading to continued use of imported, commercially sourced blood. Fibrinogen preparations—the cause of this drug-induced hepatitis—were approved in 1964. Although also used abroad, the U.S. Food and Drug Administration withdrew its approval in 1977 because of the high risk of viral infection, questionable efficacy, and the existence of safer alternatives. This information was known within Japanese pharmaceutical companies but was not conveyed to the Ministry of Health and Welfare. In 1987, a report from an obstetrician that “pregnant women were developing hepatitis after administration of fibrinogen preparations” prompted pharmaceutical companies to recall non-heat-treated fibrinogen. As the recalled products were destroyed, subsequent testing of contamination routes and viral loads became impossible. Although the companies submitted a list of infected patients to the Ministry, no notifications were ever sent to those individuals; the list was simply left unacted upon. On the same day as the recall, pharmaceutical companies applied for the approval of heat-treated fibrinogen. The Ministry granted approval but requested that the indication for non-heat-treated preparations be limited to congenital disorders. The obstetrics community opposed such limitations. It was not until 1998 that the Ministry finally restricted the drug’s indication to congenital hypofibrinogenemia. In 2000, the Ministry created a project team, and in 2001, it launched a survey on viral hepatitis infections resulting from blood-product use. Its 2002 report, “Report of the Survey on Infection with HCV Acquired through Fibrinogen Preparation,” recommended comprehensive reforms to ensure the safety of pharmaceuticals and biologicals.

2. Victims organize and take action

In 2002, victims and bereaved families began filing damage-compensation lawsuits in Tokyo and Osaka, soon expanding nationwide. Many plaintiffs were women who, years earlier, had received fibrinogen preparations during childbirth and later developed hepatitis C. They suffered not only from the disease itself but also from social stigma, prejudice, and severe side effects of interferon therapy. Their children’s generation also joined the campaign, helping with street demonstrations and public appeals. The issues in court included whether the risk of HCV infection had been foreseeable and whether the therapeutic benefits outweighed known dangers. Evidence revealed that both the government and the pharmaceutical companies had multiple opportunities to prevent the harm—such as through product re-evaluation after name changes or following the U.S. withdrawal—but failed to act because of collusive ties between bureaucrats and pharmaceutical companies, including post-retirement placements. After a series of judgments recognizing state and corporate liability in 2007, then-Prime Minister Yasuo Fukuda announced a plan for across-the-board relief through Diet legislation. In 2008, the act on “Special Measures for Relief of the Victims of Hepatitis C Virus Infection” was passed unanimously. A “Basic Agreement” between the state and plaintiffs established a framework for equal compensation to all victims.

3. Institutional reforms and ongoing oversight

In 2008, the Ministry of Health, Labour and Welfare (MHLW) created the “Examination and Study on Hepatitis caused by use of Hepatitis C Virus-Tainted Blood Products and Prevention of the Recurrence.” Its deliberations led to a 2010 final report recommending the creation of a third-party monitoring and evaluation body for pharmaceutical administration. Following that recommendation, in 2020, the “Committee on Oversight of Pharmaceuticals and Medical Devices Safety Regulation (CoPMed)” was established within the MHLW to oversee drug-safety governance and prevent the recurrence of drug-induced suffering.

References

1. The Pharmaceutical and Medical Device Regulatory Science Society of Japan (2012), 『知っておきたい薬害の教訓――再発防止を願う被害者からの声』YAKUJI NIPPO, (ISBN 4840812136).
2. The Pharmaceutical and Medical Device Regulatory Science Society of Japan (2011), 『知っておきたい薬害の知識』Jiho, (ISBN 4840741743).