A company in New Jersey that supplied human tissue for surgical procedures and transplants has been accused of conspiring to steal tissue from the corpses of people who never gave permission to be donors.
After an investigation by the US Food and Drug Administration and the Brooklyn District Attorney’s Office, which lasted more than 18 months, a 122 count indictment was served on Michael Mastromarino, owner and executive director of Biomedical Tissue Services of Fort Lee, New Jersey, and funeral home directors Joseph Micelli, Lee Crucetta, and Christopher Aldorasi.
The four defendants allegedly forged death certificates and consent forms for organ donation. They have also been charged with enterprise corruption, body stealing and opening graves, unlawful dissection, and other counts.
Last month, the FDA issued a cease and desist order against Biomedical Tissue Services and Mr Mastromarino. All tissue products initially recovered from human donors by the company were recalled.
“FDA’s investigation of [Biomedical Tissue Services] revealed serious and widespread deficiencies in their manufacturing practices that provide the agency reason to believe that allowing the firm to manufacture would present a danger to public health by increasing the risk of communicable disease transmission,” said Margaret Glavin, the FDA’s associate commissioner for regulatory affairs.
The agency’s inspection of the company uncovered serious violations of the regulations that cover donor screening and record keeping. The firm had also not adequately screened donors for risk factors or for clinical evidence of relevant communicable diseases. In addition the agency found numerous instances in which death certificates in the company’s files were at variance with the death certificates that the FDA had obtained from the state in which the death had occurred.
The FDA has asked hospitals to contact hundreds of patients who had received body parts from the company between early 2004 and September 2005, to be tested for AIDS, hepatitis, and syphilis. The administration acknowledged that the risk is low but unknown.
Bobi Milner, a 41 year old woman from Springfield, Illinois, had surgery last year to treat degenerative disc disease in her cervical spine. She recently learnt that her bone graft was possibly taken from the journalist and broadcaster Alistair Cooke, who died aged 95 of cancer in March 2004. Mr Cooke was too old and sick to be an acceptable candidate for tissue harvesting.
Mr Cooke’s daughter, Susan Cooke Kittredge said that she had never given permission for the removal of Mr Cooke’s tissues. But investigators from Brooklyn District Attorney’s Office contacted her recently to say that they had discovered forged papers, allegedly signed by Mr Cooke’s family, allowing his bones and tissues to be removed before his cremation.
Patricia Battisti, another woman who had received tissue from the company, said that she was considering suing the company, her surgeons, and North Shore-Long Island Jewish Health System. She claims that she contracted syphilis after a bone graft during back surgery at Franklin Hospital Medical Center. She learnt in a hospital letter last December that she may have received improperly screened tissue from Regeneration Technologies, a company in Alachua, Florida, that obtained the tissue from Biomedical Tissue Services.
Human tissue is a $1bn (£580m; €840m) a year industry, with more than a million tissue transplants performed each year, says Raj Denhoy, an analyst with investment company Piper Jaffray.
The American Association of Tissue Banks accredits 91 tissue banks nationwide every three years, and the FDA also conducts periodic inspections, according to Robert Rigney, the executive director of the association.