FDA Provides Information on Investigation into Human Tissue for Transplantation FDA.GOV - October 26, 2005

The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005.

Gary W. Kendall and the Allograft Transplant Litigation is currently investigating cases involving potentially unsanitary and diseased human tissue, bones and organs being used in transplant surgeries nationwide. 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 disease. This $1 billion industry, according to investment firm Piper Jaffrey, has been under increased scrutiny following an FDA probe last fall into an alleged body snatching ring. However, this issue stems far beyond the recent investigation 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. Gary W. Kendall and the Allograft Transplant Litigation is currently investigating 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

According to an FDA report, victims of unsafe and tainted transplants may have undergone treatment as far back as early 2004, perhaps earlier, and hospitals nationwide have reported receipt of the illegally harvested and potentially dangerous tissue. Recalls have been issued by the following tissue processing firms:

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

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

Again, this problem may extend far beyond what has been included in these recalls. It has only been since May 2005 that federal regulations have been put in place for the screening and inspection of human tissue. Therefore, ANYONE who has received a tissue transplant or bone graft and has been inexplicably diagnosed with Hepatitis, HIV, Syphilis or other infectious diseases should take the necessary steps to protect their legal rights.

Although there is no guarantee of infection from diseased cadaver bone or tissue to a healthy recipient, SERIOUS infections have been reported and it is recommended that all recipients be tested for the following:

Hepatitis B Virus (HBV): HBV often can present with flu-like complaints in the initial phase, then possibly go on to a symptom-free carrier (dormant) state. The degree of clinical symptoms of HBV infection varies in both acute (early) and chronic (late) disease. The chronic phase can progress to cirrhosis (scarring) and liver cancer.

Hepatitis C Virus (HCV): With HCV the early process is most often without symptoms. Acute HCV typically leads to chronic infection; 60-80 percent of cases develop chronic hepatitis (abnormal liver enzymes). Chronic HCV is usually slowly progressive. Approximately 20 to 30 percent of the chronically infected individuals develop cirrhosis over a 20-30 year period. Chronic HCV is the most common cause of chronic liver disease and the most frequent indication for liver transplantation in the United States.

Both viruses can be detected by blood tests, however it may take weeks to months for the results to turn positive and individual cases vary widely. The same can be said for the virus responsible for AIDS - HIV. Testing at intervals and long term observation is required. Lastly, screening for Syphilis is mandated. Each disease presents difficulties in diagnosis. The ongoing testing and increased uncertainty poses 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.

Gary W. Kendall and the Allograft Transplant Litigation Team have the experience and skill to represent those that have been wrongfully injured by the medical industry. Our attorneys have several years experience fighting for victims of medical malpractice, faulty medical devices, and unsafe pharmaceuticals. MichieHamlett is currently fighting against this injustice together with co-counsel Ron Motley and Kevin Dean from Motley Rice and Jack Cordray from the Cordray Law Firm in Charleston, South Carolina.

If you feel that you or a loved one may be a victim of an unsanitary bone/tissue transplant or unauthorized body-part harvesting, please contact us at 1-800-451-1288 to explore your legal rights.

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Copyright @ 2009 Michie Hamlett Lowry Rasmussen & Tweel, PLLC