Legal

Creutzfeldt-Jakob Disease Suit Filed In Japan

TOKYO, Apr 23 (Reuters) - The first criminal accusation in Japan involving
Creutzfeldt-Jakob disease (CJD), alleging use of contaminated dura mater,
was filed in December, according to an article in The Japan Times.

The husband and brother of a 43-year-old woman diagnosed with CJD accuse two
medical suppliers of having continued to import dried dura mater from a
German pharmaceutical company when company officials knew that the tissue
could be contaminated with the potentially fatal prion, the newspaper says.

The woman contracted CJD after receiving a dura mater transplant in January
1989, with symptom onset occurring seven years later. She became comatose
three months after the onset of symptoms. The plaintiffs charge that the two
Tokyo-based firms failed to recall the unsterilized tissue after the
supplier started sterilizing dura mater, the newspaper reported.

The Japanese health ministry banned the import and use of dura mater grafts
in 1996.

The accused are a former president of Nippon BBM and the president of Nippon
BBS, which distributes the German company Braun Melsungen's products in
Japan. All known cases of CJD from dura mater in Japan have been linked to
Braun Melsungen's Lyodura dura mater grafts. A company representative has
been reported as saying that the product recall was not fully applied in
Japan because of a linguistic misunderstanding.

A nongovernmental surveillance group for CJD in Japan indicates that an
international outbreak of CJD associated with the single brand of dura mater
grafts is larger than previously recognized. According to Dr. James Chin of
the Armed Forces Epidemiological Board, the University of California at
Berkeley and an Honorary Professor of the University of Hong Kong,
recipients of contaminated grafts may remain at risk for CJD at least 16
years following transplantation.

-Westport Newsroom 203 319 2700

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