Tainted Tissue

The human tissue banking industry, which was once based on good will and donation, has been turned into an unfortunate "commodity" trade that puts profit over safety at the expense of dignity and the development of disease.

Human tissue banks obtain human tissue such as bone, tendons and skin from deceased donors then send it to tissue processing firms. These tissues are then distributed to hospitals and medical facilities throughout the country for transplants, also known as allografts, in surgical patients. Although the FDA requires tissue companies to screen donors for key risk factors, including age, cause of death and infectious diseases, the industry is under increased scrutiny following a 2005 FDA probe into an alleged body snatching ring.

Human Tissue Investigations and Recalls

In October 2005, the FDA publicly announced an investigation of Biomedical Tissue Services, Ltd., regarding improper screening for tissues recovered and sent to processing firms. Following the announcement, the tissue processing firms issued voluntary recalls for all unused human tissues and in February 2005, the FDA ordered Biomedical Tissue Services to cease operations. According to the FDA report, victims of unsafe tainted tissue and contaminated bone transplants may have undergone treatment as early as 2004 through September 2005. Additionally, hospitals nationwide have reported receipt of the illegally harvested and potentially dangerous tissue.

Despite the recalls, the risks to tissue transplant patients may be extensive. This issue stems far beyond the recent investigation of this $1 billion industry and may include thousands of transplants of tissue obtained both legally and illegally, some of which may even be considered instances of assault and battery.

Human tissue recalls were issued by the following tissue processing firms:

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

Parts included in the recall were distributed between October 2003 and September 2005 and include human bone, skin, and tendons.

Tainted Tissue Litigation

Motley Rice is investigating cases involving potentially unsanitary and diseased human tissue, bones and organs being used in transplant surgeries nationwide.

Our attorneys are litigating cases on behalf of:

• victims of transplants that may have included tainted body parts 
• family members of those whose bodies have been illegally tampered with and/or stolen

Federal regulations for the screening and inspection of human tissue have only been in place since May 2005, making tainted tissue an issue that may reach far beyond these recalls. Any patient who has received a tissue transplant or bone graft and has been inexplicably diagnosed with Hepatitis B and C, HIV, syphilis or other infectious diseases should take the necessary steps to protect his or her legal rights.

Infection from Tissue Implants

Although there is no guarantee of infection from diseased cadaver bone or tissue to a healthy recipient, serious communicable infections have been reported and it is recommended that all recipients of tissue from the identified firms be tested for Hepatitis B, Hepatitis C, HIV and syphilis. Most of these infections can be detected by blood tests, however, the latency period of these diseases may take weeks to months to years to appear and individual cases widely vary. Testing and medical monitoring should be done at regular intervals with ongoing medical observation.

The continuous testing and increased uncertainty of disease can inflict serious psychological damage for all transplant patients. Even if they are never diagnosed, people have rights not to be "battered" or receive unapproved, untested and unauthorized human tissue.

Motley Rice is investigating cases involving the transplant of potentially unsafe, contaminated human tissue, bones, skin or organs in surgeries across the United States. Our attorneys currently handle over 500 tainted tissue cases, and lawyer Ron Motley is lead counsel for the tainted tissue multidistrict litigation.

For more information, contact attorney Kevin Dean by email or call +1 800.768.4026.