Biomedical Tissue Services, Ltd. Recall Overview

On October 13, 2005, Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, New Jersey initiated a recall of tissue that was collected from donors due to the discovery that portions of this tissue were donated by those with unacceptable health histories. As a result, tainted tissue was used in procedures around the country, leading to the potential for serious injuries and death.

Types of Tissue Recalled

The FDA reported that the tissue that originated from BTS included human bone, skin, and tendons.  These products represent only a small percentage of the overall U.S. tissue supply, according to the FDA.

Potential Liability of BTS

What appears to be at issue in this situation is who is responsible for this infected tissue being disseminated to medical facilities. As a result, the question of liability is complicated. It appears that BTS did not perform all of the FDA-approved screening on donors for prior health problems, which would indicate potential liability.

However, after the recall was issued, if medical facilities failed to remove the tissue in question from use, and that facility either did have or should have had notice of the problem's existence, that medical facility could also be exposed to liability.

Regardless of how you may have received tainted tissue, the first thing you should do is contact an experienced attorney to help you answer the question of liability.

Potential Injuries of Tainted Tissue.

Although the FDA did not report any instances of serious injuries or death as a result of receiving this tainted tissue, the FDA's Web site also lays out requirements for the communicable diseases for which all donor tissue must be tested. These diseases, according to the FDA, include HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus and syphilis. Obviously, contracting any of these diseases will cause serious injury and possibly death

Firms on Notice.

The initial target of the recall notice by BTS was directed at the firms who received this tissue, including:

• LifeCell Corporation of Branchburg, NJ
• Lost Mountain Tissue Bank of Kennesaw, GA
• Blood and Tissue Center of Central Texas in Austin, TX
• Tutogen Medical, Inc., of Alachua, FL
• Regeneration Technologies, Inc., of Alachua, FL

The firms above voluntarily recalled any unused tissue in question, and they continue to work with the FDA in notifying physicians who used other inventory so that the patients can also be notified.

If any of the above facts fit your situation, you need to contact an experienced trial attorney immediately for a full consultation.