Tainted Human Tissue Results in Recall and Risk of Disease

Jack Landskroner

Contributor

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Individuals across this country have received stolen human tissue during routine surgical procedures requiring bone and tissue transplants. These procedures, also known as allografts, have put recipients at increased risk for HIV, Hepatitis, Syphilis and other infectious disease processes.

In December of 2005 the FDA announced a recall of tissue harvested by a New Jersey company know as Biomedical Tissue Services (BTS). The recall was based upon the company's alleged improper and illegal screening, recovery, processing and distribution of tissue stolen from cadavers without authorization.

The continuing FDA investigation determined that information for some donors (e.g., cause, place, or time of death) was not consistent with death certificate data obtained from the states where the deaths occurred. The investigation also determined that BTS had failed to recover tissues in a manner that would prevent contamination or cross-contamination and failed to control environmental conditions adequately during tissue recovery.

In February 2006 our offices filed a class action lawsuit against BTS and its partner companies involved in the processing and distribution of this tainted tissue including Regeneration Technologies, Medtronic, Tutogen Medical, LIfecell and others. The action seeks damages for injured victims as well as medical monitoring for these recipients of tainted tissue. The tissue in question is believed to have been distributed to as many as 8000 surgical patients who received allografts in conjunction with orthopedic, oral, maxillofacial, urinary and cardiovascular surgeries as well as skin grafting procedures taking place across the United States.