Tissue Lawsuit

With bad paperwork, that was apparently doctored, in order to claim that the donors were younger and in good health, BTS pulled off this scam. The most important information such as place of death, time of death, and the identity of the next of kin conflicted.

No one can rely on the donor screening performed and cannot rely on this to exclude that the donors has risk factors for or clinical evidence of infectious diseases.

The Food and Drug Administration, under this administration, has been an abomination. Regulations require that, before tissues are released for distribution, blood samples from each donor be provided to the testing laboratory for donor testing. Each sample must be clearly linked to an individual donor, and each tissue clearly linked to that donor. In some instances, blood samples did not come from the same donor as the linked tissues. The results of communicable disease tests obtained from the blood sample may not correctly reflect the status of the donor.

Any unused tissue has been voluntarily recalled by the processors and they have notified the transplant physicians, said a statement by the FDA. Physicians who transplanted tissue directly from BTS were also contacted, according to an attorney familiar with the issue.