In the latest of a series of lawsuits against the Japanese government and manufacturers of blood products, the Tokyo District Court ruled in favor of 13 plaintiffs who had contracted hepatitis C (HCV) through contaminated drugs. The court has ordered the defendants, including the government, Nihon Pharmaceuticals Company, Mitsubishi Pharma Corporation and its subsidiary, Benesis Corporation, to pay a combined total of 259 million yen, equivalent to nearly $2.2 million.
Judge Atsuro Nagano ruled that the government and the pharmaceutical companies were negligent—distributing products without properly warning patients that they carried a known risk for HCV. “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,” said Nagano.
The suit was first filed in October 2002 by 13 plaintiffs who were treated with plasma-derived fibrinogen (a key blood clotting protein) concentrates and other blood products, between the years 1980 and 1988. The defendants’ case was further damaged when fibrinogen lost U.S. Food and Drug Administration approval in 1977, after it became clear that the product was a vehicle for blood-borne hepatitis transmission. Eight additional plaintiffs later joined the suit. Two of the original plaintiffs have since died, but their families have taken up their cause.
Fibrinogen and other plasma products were commonly used in the 1970s by Japanese obstetricians, gynecologists and surgeons to treat hemophilia or stop hemorrhaging during childbirth or surgeries.
“I was relieved when the judge read out his ruling,” said one of the plaintiffs, a 21-year-old patient who was infected by his mother and was treated with fibrinogen during 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.”
The products used in Japan preceded the advent of viral inactivation methods such as heat and solvent-detergent treatment. Even as these methods became available in the late 1970s, several pharmaceutical companies were reluctant to employ them due to cost and efficacy concerns. Those companies were more vulnerable to charges of negligence when HIV infected the blood supply in the early 1980s, initiating an epidemic that devastated the global hemophilia community.
Green Cross Corporation, a Japanese company, was the primary source of the HCV-tainted therapies. It merged with Mitsubishi Pharma Corporation in 2001 after an earlier merger with Yoshimitsu Pharmaceuticals Ltd. in 1998. The company was also at the center of the AIDS crisis in Japan for distributing HIV-contaminated blood products. The ensuing scandal forced Green Cross to reach an out-of-court settlement with patients in 1996.
Similar suits from other districts—Osaka and Fukuoka in 2006—either were found in favor of the plaintiffs or are pending a ruling.
Source: The Japan Times, March 24, 2007