Hepatitis C plaintiffs win 259 million yen

Tokyo court faults state, drugmakers for infections

by Jun Hongo

The Tokyo District Court ordered the state and three drugmakers Friday to pay a combined 259 million yen in damages to 13 of 21 plaintiffs infected with the hepatitis C virus from tainted blood products.

The verdict is the third in as many rulings handed down in a series of similar lawsuits that found the government and pharmaceutical companies guilty of not regulating the use of unheated coagulants despite being aware that such products might contain the hepatitis C virus. The blood products were commonly used in the 1970s by obstetricians, gynecologists and surgeons to treat hemophilia or stop hemorrhaging during childbirth or surgery.

Presiding Judge Atsuro Nagano ruled that the state and Nihon Pharmaceuticals Co., Mitsubishi Pharma Corp. and its subsidiary, Benesis Corp., were responsible for spreading the virus and condemned the defendants, saying that “warnings and regulations were not made properly or sufficiently,” resulting in the increase of hepatitis C virus infections.

The plaintiffs’ lawyers welcomed the verdict, which for the first time ruled against the use of christmassin as well as fibrinogen — both unheated blood-clotting agents — after January 1984, when the court determined that the risk of infection with the virus was known by the drugmakers.

“I was relieved when the judge read out his ruling,” said a 21-year-old patient who was infected through his mother, who was administered the drug during his birth.

“I am happy but it’s sad that there were people who just happened to be treated with the same medicine but denied compensation because of the time of their exposure,” said the plaintiff, who asked to remain anonymous.

The suit, originally filed in October 2002 by 13 plaintiffs who were treated with fibrinogen and other blood products between 1980 and 1988, alleged that the defendants failed to restrict the distribution of coagulants even after they were banned in the U.S. in 1977.

Eight other plaintiffs later joined the suit, while two of the original plaintiffs have since died. Their legal fight was taken over by their families. They were demanding a combined 1.3 billion yen in damages.

The defense claimed that fibrinogen and other coagulants were considered valid medication for hemophilia and hemorrhage at the time, alleging that use of the drugs was acceptable.

But the Tokyo court Friday rejected such claims and ordered the government and the three drug firms to pay damages to those who contracted hepatitis through tainted blood products.

“The drugs may have been valid but being infected with the hepatitis C virus is too much of a side effect, considering the seriousness of the disease,” the judge said.

A combined 160 plaintiffs have so far sued the central government and drugmakers in five district courts nationwide.

In June 2006, the Osaka District Court awarded 260 million yen in damages to nine of the 13 plaintiffs, claiming the state and drug companies failed to effectively prevent spread of the disease after an unusually large number of hepatitis C infections were reported in Aomori Prefecture in April 1987. The court found the state guilty for all use of contaminated blood products after the 1987 outbreak, and the drugmakers after August 1985.

The Fukuoka District Court expanded on the Osaka ruling, claiming both the state and pharmaceutical firms were responsible for all use of contaminated blood products after November 1980, by which time, the court determined, the risk would have been known among the state and drugmakers given the U.S. government decision to stop its use in 1977.

It ordered the defendants to pay a combined 168 million yen in damages last August to 11 of 18 people infected with hepatitis C from tainted blood products. The plaintiffs and defendants have appealed both rulings.

District court rulings for the other plaintiffs are still pending in Sendai and Nagoya, while more patients continue to file new lawsuits in the five district courts.

Unheated blood products, including fibrinogen, were commonly used in the 1970s by obstetricians, gynecologists and surgeons to treat hemophilia or stop hemorrhaging during childbirth or surgeries.

But the blood-clotting agents were later suspected to be infected with hepatitis, and the U.S. Food and Drug Administration canceled its approval of fibrinogen in 1977.

However, the Japanese government did not take immediate action and drugmakers continued to produce and sell the drugs until safer heated products became available in the late 1980s.

Now-defunct Green Cross Corp., which merged with Mitsubishi Pharm in 2001 after an earlier merger with Yoshimitsu Pharmaceuticals Ltd. in 1998, was the main supplier of fibrinogen and other tainted products.

Green Cross was also at the center of an HIV infection scandal in the 1980s for causing an outbreak of HIV/AIDS through contaminated blood products. The disgraced drugmaker giant reached an out-of-court settlement with HIV/AIDS patients in 1996.

An estimated 3.5 million people in Japan have been infected with the hepatitis C virus, according to the plaintiffs, but public awareness of the disease remains low even today.

Because of a societal bias against those with the disease, only a small number of patients submit to tests for the virus, which is transmitted through blood or other bodily fluids.

Hepatitis C infection is rarely detected in its early stages, and many patients may not discover they are carriers for decades, by which time potentially fatal liver cancer or cirrhosis has set in.