So far, eight lawsuits have been filed against Biomedical Tissue Services (BTS) on behalf of unwilling donors. Additionally, hundreds more lawsuits are pending on behalf of people who received the illegally harvested tissue in the tissue transplant.
BTS allegedly took tissue from cadavers in funeral homes. The lawsuits allege that the company did not obtain the proper permission from either the donor before death or the donor's family after death. The tissue was then used in tissue transplants.
The company did not get permission to take the tissue from the cadavers. Furthermore, BTS did not take proper measures to screen the tissue for the presence of communicable diseases and did not harvest the tissues in sterilized conditions. The company also faked death certificates and forged signatures allowing them to harvest the tissues.
In ordering BTS to cease all operations, the FDA said, "Despite records maintaining otherwise, the firm had inadequately screened donors for risk factors for, or clinical evidence of, relevant communicable disease agents and diseases. In addition, FDA found numerous instances where death certificates maintained in BTS' files were at variance with the death certificates FDA obtained from the state where the death occurred, on important information such as cause, place, and time of death, and the identity of the next of kin.
After initially focusing efforts on assessing the safety of distributed tissues and facilitating the appropriate recalls, the Agency has determined that these violations, because of their serious nature, constitute a danger to health and is taking this unprecedented action."
A major concern is that the tissue that was harvested came from people who had various diseases. In some cases, the unwilling donors had AIDS, Hepatitis B and C, or various forms of cancer. It is possible for the transplanted tissue to infect the recipient of the tissue transplant. Furthermore, tissue that is not properly disinfected could cause life-threatening infections. Brian Lykins died after a 2001 tissue transplant to repair his knee. The cartilage that was transplanted had not been properly disinfected and the resulting infection killed him.
One lawsuit against BTS claims that a victim caught Hepatitis B and C from tissue implanted into his back.
Over one thousand corpses may have been used as donors during the four years BTS was in business. The bodies were sold for between $100,000 and $250,000. In the years it was in business, BTS made $4.7 million.
The National Organ Transplant Act is meant to safeguard against such criminal activity, but there is no legislation that monitors tissue or whole body donation. It is illegal to pay for body parts for transplant, but processing fees are not illegal.
The FDA said that 25,000 tissue products had been distributed across the United States and overseas. In Canada alone, 10 people have filed a $210 million lawsuit against the company.
BTS stopped its operations a year ago after the FDA ordered the company to cease all business practices. The owner of the company could be facing criminal charges connected to the harvesting of tissues without proper consent.
Many people who received a tissue transplant are now learning that the tissue they received could be infected. The FDA has recalled of thousands of pieces of bone, skin, and other tissue, all collected by BTS.
If you had a tissue transplant and think you may have received tissue that was improperly harvested, contact your doctor immediately.
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