Tainted Donor Tissue Recall

In October 2005, the Food and Drug Administration (FDA) issued a national recall of contaminated human tissues used in various surgical procedures. First provided by Biomedical Tissue Services (BTS) in 2001, human tissues were collected from qualifying cadavers and used for skin and bone grafts, dental and optical implants, blood vessel and tendon replacements, and organ repairs.

Within a few years patients began reporting that they were developing some severe health complications. Ensuing investigations revealed that BTS and another tissue-service company (CryoLife) were not following the FDA-defined procedures for screening donors and cleaning tissues.

Medical Tissue FDA Warning Reveals BTS’s Criminal Behavior

Specifically, BTS was criminally violated the FDA’s policies regarding the collection and distribution of human transplant tissues by forging donor consent forms and death certificates.

Between 2002 and 2005, more than 50 percent of the tissue used in transplant procedures and surgeries came from BTS or CryoLife. BTS collected 13,000 tainted human tissues and experts estimate that around 8,000 of them were implanted in patients. Tragically, those who have received a tainted tissue transplant have a significant risk of developing HIV/AIDS, hepatitis, syphilis, or other serious diseases.

Effects of the FDA Tainted Donor Tissue Recall

Although the 2005 FDA warning regarding tainted donor tissue focused public attention on the criminal behavior of BTS, the “recalled” tissues could not simply be extracted from patients. Many of the patients have already developed severe health complications that have greatly decreased their quality of life. These patients will have a strong legal claim against BTS, and they will be entitled to compensation for their outstanding and ongoing medical bills, permanent disabilities, lost wages, pain, and suffering.

Skilled diseased tissue lawyers welcome injured transplant patients to attend a complimentary initial consultation to learn more about their legal rights and receive a comprehensive assessment of their case.

If you or a loved one received bone or tissue from BTS or Cryolife and contracted HIV, AIDS, hepatitis, or syphilis you should contact us immediately for a free and confidential case review. You may be entitled to compensation and we can help.