FDA Bone Recall

The Food and Drug Administration (FDA) issued a nationwide recall of contaminated tissues and bones collected and distributed by Biomedical Tissue Services (BTS) in October 2005. Despite the FDA and the American Association of Tissue Banks (AATB) outlining specific procedures for the collection and distribution of human tissues, BTS was found to be in gross violation by being criminally negligent in the screening of donors and cleaning of tissues. Additionally, federal investigations uncovered that BTS had been forging documents, including donor consent forms and death certificates, to try to make potentially ineligible donors appear to be both eligible and willing.

Those who received any type of tissue or bone implant from 2001 through 2005 are urged to see their physician for a thorough health screening to evaluate whether they received contaminated bones or tissues. Experts estimate that approximately 8,000 of the 13,000 diseased bone and tissue specimens collected and distributed during these four years were implanted in Americans. Examples of procedures in which recalled tissues would be used include:

  • ankle procedures
  • back surgery
  • dental or corneal implants
  • heart valve replacements
  • knee, hip or joint replacements
  • skin grafts

Complications reportedly associated with implantation of contaminated bones or tissues include HIV, AIDS, hepatitis, syphilis, and other potentially irreversible and life-threatening conditions.

Following the Bone Recall

While the founders of BTS faced serious federal criminal charges due to their abhorrent disregard for federal regulations and human life, the company is also civilly responsible and the thousands of people will be entitled to a settlement for their injuries and losses. Moreover, should a medical facility fail to honor the recall by not pulling all contaminated specimens from their shelves, it too will be legally negligent and financially responsible for compensating injured patients.

Those who suspect they have sustained serious health complications due to receiving recalled bone or tissue specimens should, after seeking the appropriate medical attention, consult with an experienced contaminated tissues lawyer to:

  • Learn more about their legal rights.
  • Get expert advice regarding how to move forward with their claim.
  • Secure the superior services of an experienced diseased tissue attorney at no upfront cost to them (because these lawyers work on contingency).

If you or a loved one received bone or tissue from BTS 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.