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Feds Shut Firm Over Body-Part Scandal |
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Written by DeadGirl
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Sunday, 05 February 2006 |
Saturday, February 4, 2006
STAFF AND WIRE REPORTS
The Food and Drug Administration shut down a Fort Lee biomedical firm Friday amid allegations the company covertly harvested human tissue for profit at funeral homes in New York City and elsewhere.
The FDA sanction against BioMedical Tissue Services of Center Avenue in Fort Lee was the latest development in a scandal involving scores of funeral homes and hundreds of looted bodies, including that of "Masterpiece Theatre" host Alistair Cooke.
Federal and local authorities have been investigating whether the firm's chief executive, Michael Mastromarino, 42, of Fort Lee, and a business associate paid funeral homes so they could take bone and skin from bodies without their relatives' knowledge.
Investigators say some body parts came from elderly people and possibly from victims of infectious diseases, and the paperwork allegedly was doctored to say they had been younger and healthier.
The FDA said Friday that its investigation had uncovered evidence BioMedical Tissue failed to screen for contaminated tissue. The agency also found that death certificates in the company's files were at odds with those on file with the state over the age of the deceased and the cause and time of death.
The tissue was sold to other companies around the country that process implants and grafts used in a variety of procedures. Late last year, the FDA ordered a recall of the potentially tainted products and warned that an untold number of patients could have been exposed to HIV and other diseases.
The remains of Cooke, who died of cancer in 2004 at age 95, were carved up and snatched without his family's knowledge; a Brooklyn grandmother's leg bones were replaced with metal pipes, and a South Jersey man and dozens of others learned that the bones surgeons fused into their spines may be tainted.
The Brooklyn District Attorney's Office and the federal Food and Drug Administration are probing Mastromarino's business dealings in New York and New Jersey, where the former dental surgeon conducted the majority of the harvesting.
About a dozen funeral homes in Bergen and Passaic counties contacted recently by The Record said they had no dealings with Mastromarino, who surrendered his dental license in 2000 as a result of drug abuse.
At one time, he had dental offices in Englewood Cliffs and Fort Lee, in addition to 50th Street in Manhattan, just off Fifth Avenue.
At least one concerned funeral director in New Jersey who had worked with Mastromarino contacted authorities, a spokeswoman for the state funeral director's association said last week.
So far, nearly 60 South Jersey patients have learned that they received tissue that has been recalled by the FDA, but experts suspect the health risks are extremely limited.
Nevertheless, allowing the firm to remain open "would present a danger to public health by increasing the risk of communicable disease transmission," said Margaret Glavin, the FDA's associate director of regulatory affairs.
The Brooklyn District Attorney's office declined to comment Friday.
Mastromarino came under suspicion when a Branchburg-based company bought tissue from him, reviewed documents pertaining to the donors and found irregularities. The company discovered that the phone numbers for the physicians' donors were all wrong. The phone numbers listed for family members who gave consent for the donations also were wrong, leading the company to believe the tissue was harvested illegally. Company executives immediately alerted the FDA and voluntarily recalled compromised batches of tissue.
Mastromarino's attorney, Mario Gallucci of Staten Island, confirmed the company had ceased operations, but said his client denied the allegations and planned to go to court so he could reopen.
"Everything that was done was done according to FDA regulations," he said.
He also denied that Mastromarino took body parts without permission.
"Nobody was carving up bodies in unsanitary conditions," he said. "He was above board on everything."
Four state lawsuits and one federal suit have been filed against BioMedical. Additional lawsuits have been filed in Nassau County, N.Y., and Oklahoma.
http://www.northjersey.com/page.php?qstr=eXJpcnk3ZjczN2Y3dnFlZUVFeXkzJmZnYmVsN2Y3dnFlZUVFeXk2ODczNzAyJnlyaXJ5N2Y3MTdmN3ZxZWVFRXl5Mw==
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