Biomedical Tissue Services

Biomedical Tissue Services, Ltd. (BTS) was a Fort Lee, New Jersey-based human tissue recovery firm that was shut down by the U.S. Food and Drug Administration^[1] on October 8, 2005^[2] after its president and a number of employees were convicted of harvesting human tissue from as many as 1,000 individuals awaiting cremation and selling and distributing it without consent.^[3]

In late 2005 investigated BTS for allegedly selling stolen human body parts.^[4] The probe was first reported by the New York Daily News in October of 2005, and led to a number of exhumations, including one of a Queens, New York woman who had had many of her bones removed and replaced with PVC piping. According to government witnesses, BTS generated commercial ties to a number of funeral homes in Pennsylvania and New York in order to obtain access to recently deceased people, paying the funeral homes $1,000 per corpse.^[2] BTS employees would frequently obtain human allograft tissue samples without authorized consent and did not test the tissues for diseases according to the regulations imposed by the FDA. Under federal regulatory guidelines for the proper care and management of donated human tissue, firms are required to "screen and test donors for relevant communicable disease agents and diseases and to ensure that HCT/Ps are processed in a way that prevents communicable disease contamination and cross-contamination."^[5]

To conceal their deceitful practices, BTS employees forged a variety of the necessary certificates and even, as reported in the case of the exhumed Queens woman, replaced bone with piping to fool family members of the deceased.^[1] The ruse became international news fodder after it was determined that the deceased Alistair Cooke, a famed British broadcaster, was among the remains that were violated.^[6][7][8]

In February 2006, Dr. Michael Mastrimonio,^[9] then a 42-year-old^[10] former New Jersey-based oral surgeon and CEO and executive director of operations of BTS,^[5] was convicted along with three employees of wrongdoing and sentenced to prison terms. Mastrimonio and Lee Crucetam, one of the convicted employees, agreed to a deal that resulted in their imprisonment.^[3] Mastrimonio was sentenced on June 27, 2008 in the Supreme Court in Brooklyn, New York to between 18 to 54 years in prison.^[11]

On September 4, 2008, defense attorneys for human graft tissue distributors asked U.S. District Judge William J. Martini to dismiss hundreds of charges, asserting that the companies "never knew the body parts were illegally obtained, and they say there is no evidence the transplanted tissue made anyone ill."^[12]

According to the FDA, all tissue products collected and distributed by BTS were recalled and will be monitored for a complete accounting of all graft material.^[5] BTS sold its products to five companies; two of the companies were Life Cell Corporation, of New Jersey, and Regeneration Technologies, of Florida. Overall, about 10,000 patients in the U.S and Canada received graft tissue from BTS.^[10]

BTS was not an accredited member, nor did the company ever apply to be a member, of the American Association of Tissue Banks. Robert Rigney, who heads the association, said he doubts anyone who received tissue donations originating from the company is in any kind of health danger, because the processors the company dealt with would have subjected the tissues to their own screening processes.^[13]

References

External links

U.S. Food and Drug Administration Order to Cease Manufacturing and to Retain HCT/Ps

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