Contradicting its previous claims, the government has admitted that Japan probably imported German medical products that reportedly caused Creutzfeldt-Jakob Disease even after the United States had warned of the danger in 1987.
Kazuo Maruta, a senior Health and Welfare Ministry official, said Wednesday that the German-made dried dura mater was produced in 1982 was probably imported before 1997.
Dried dura matter is a medical product used during brain surgery.
The U.S. Food and Drug Administration in 1987 issued a domestic advisory not to use the suspect dura mater after learning about a report that it could cause CJD.
Symptoms of the disease include rapidly progressive dementia, loss of cerebral functions and paralysis of limbs, with parts of the brain becoming spongelike.
Maruta, chief of the ministry’s Pharmaceutical and Medical Safety Bureau, told members of the Health and Welfare Committee at the House of Representatives that it is “likely” that the product, Lyodura, with serial numbers from 2000 to 2999, was imported to Japan.
He cited a report by Tokyo importer Nihon B.S.S. that says 12,545 boxes of the dura mater, manufactured in 1982 by B. Braun Melsungen AG, were imported that year.
Health and Welfare Minister Yuji Tsushima also told the committee, “It was impossible (for the government) to foresee the dangers.”
Previously, the ministry had denied the possibility of any imports, insisting that Lyodura with the serial number 2105, which the U.S. government said caused the first-discovered case of CJD, was not imported to Japan.
The German firm recalled the 2105 Lyodura in early 1987 and the FDA advised domestic medical facilities to abandon the product with serial numbers from 2000 to 2999.
It was only 10 years later that the Health Ministry prohibited use of the product.
More than 40 people, including CJD victims and their relatives, have filed two damages suits with the Tokyo District Court and the Otsu District Court in Shiga Prefecture, accusing the central government, the Japanese companies involved and the German firm of negligence.
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