Tainted Tissue



 

On February 3, 2006, the Food and Drug Administration (FDA) ordered Biomedical Tissue Services, Ltd. (BTS), a human tissue-recovery firm based in Fort Lee, New Jersey, to immediately cease all manufacturing operations. The firm was cited with "serious and widespread deficiencies" in their manufacturing practices, which the FDA called an immediate danger to public health.

Stolen Body Parts
Until they were shut down by the FDA, BTS supplied bone, skin and tendons to various processors, who in turn provided them to distributors. BTS has been accused of collecting body parts without donor consent and selling them for use in transplant procedures performed at hospitals and other healthcare facilities across the country.

While the exact amount of distributed tainted tissue is unknown, hospitals are now contacting hundreds of patients who may be at risk. Tissue distributor Medtronic Inc. recently came forward with a report that stated they implanted as many as 8,000 pieces, all of which came from BTS.

The following is directly from the FDA press release:
The FDA order to cease manufacturing requires BTS to suspend any and all manufacturing steps, including but not limited to the recovery and shipment of human tissue. FDA inspection of BTS uncovered serious violations of the regulations governing donor screening and record keeping practices, as well as failures to follow their own standard operating procedures, failure to recover human tissue in a manner that does not cause contamination or cross-contamination during recovery, and failure to adequately control environmental conditions.

Following the FDA report of the BTS tainted tissue scandal; several tissue processing firms have issued immediate recalls:
  • Tutogen Medical, Inc., Alachua, Florida
  • Regeneration Technologies, Inc. (RTI), Alachua, Florida
  • LifeCell Corp., Branchburg, New Jersey
  • Lost Mountain Tissue Bank, Kennesaw, Georgia
  • Blood and Tissue Center of Central Texas, Austin, Texas
Bone Tissue Recall
According the an FDA report, patients who may have received tainted tissue and contaminated bone transplants may have undergone treatment as far back as the beginning of 2004, if not earlier. Parts that are included in the FDA recent recall were distributed between October 2003 and September 2005 and include human bone, skin and tendons.

There is no guarantee that recipients of tainted tissue will become infected, however serious infections have been reported. It is strongly recommended that those who received bone or tissue transplants during this time period are immediately tested for the following:
  • Hepatitis B
  • Hepatitis C
  • HIV-AIDS
  • Syphillis
If you or a loved one received a tissue transplant or bone graft and have since been diagnosed with Hepatitis, HIV, Syphilis or other infectious disease, contact us immediately at 800.966.4999 and see why our law firm has recovered over $100 million on behalf of our clients.
 
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