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August 08, 2020  
MEDTECH NEWS: Technology & Innovation

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  • Multimillion-Dollar Demand Scandal

    Multimillion-Dollar Demand + Lack of Adequate Regulation = Scandal


    March 09, 2006

    By: Jean Johnson for Medtech1

    A former oral surgeon, Michael Mastromarino – who lost his license because of a Demerol addiction – two assistants who helped him replace cadaver bones with plastic piping and the owner of the host funeral home aren’t conducting business as usual today… or tonight rather.
    Learn More
    Fast Facts About Tissue Donation

    The National Transplant Organ Act dictates strict safety requirements for donated organs but tissue is exempt because of protests by the Lions Club and others in 1984, according to Nancy Herin of the Funeral Consumer’s Alliance of Maryland and Environs.

    In 2001 the Health and Human Services Office of the Inspector General (OIG) issued a report identifying problems with FDA oversight. Herin explained that “The OIG report pinpointed the flaw: Not all tissue banks were inspected; many aspects of tissue bank quality were not monitored; there was no prescribed cycle for re-inspecting tissue banks.”

    According to the American Association of Tissue Banks (AATB), tissue donations can include:

  • Donated corneas to avert or correct blindness.

  • Skin grafts for critically-burned patients

  • Donor heart valves to help repair cardiac defects or damage

  • Bone, cartilage and tendon grafts help restore function in people who would otherwise be incapacitated or disabled.


  • Indeed, much of the quartet’s ghoulish conduct took place under the cover of night in the secret operating room Brooklyn funeral home owner, Joseph Nicelli, had added onto to his operations. Grisly doings were also undertaken out in graveyards where bodies that families thought they had laid to rest were unearthed in the fashion of some bizarre Sherlock Holmes novel.

    Now that the covert operation has seen the light of day, patients who received transplanted material between 2001 and 2005 from the Biomedical Tissue Service are being advised to get tested for HIV, hepatitis and syphilis.

    Biomedical Tissue Company was owned by Mastromarino. The Food and Drug Administration (FDA) shut it down in early February 2006 for failing to screen properly for contaminated tissue. But that’s just the tip of the 122-count indictment against the quartet.

    More, families like that of the late Alistair Cooke, longtime host of Masterpiece Theatre who died of cancer and whose body was subsequently mined without authorization by the group, are wondering how it could be.

    “I think we can agree that the conduct uncovered in this case is among the most ghastly imaginable,” said Rose Gill Hearn, commissioner of the New York City Department of Investigation. “It was shockingly callous in its disregard for the sanctity of human remains.”

    Rise of Biomedical Technology

    More than a million Americans annually have procedures that use bone or tissue from cadavers, such as disc replacements or dental implants. As with any business in its relative infancy, the sector suffers from inadequate regulation. As many entrepreneurs seek their fortunes in what has become a highly lucrative trade, the field is ripe for abuse.

    While “the tissue industry used to be a mere $20 million market,” according to Nancy Herin of the Funeral Consumer’s Alliance of Maryland and Environs, “about 10 years ago, biomedical technology, which pioneered ways to craft human tissue into products for orthopedic, cardiac, and cosmetic surgery, exploded along with the demand for raw material: human tissue.”

    In 2002 and 2004, directors of anatomical gift programs were dismissed for suspect conduct in the traffic of illicit body tissue, first at the University of Texas then at the University of California at Los Angeles. Herin concludes that the scandals of 2002 and 2004 are what happens when Congress side-steps its regulatory responsibilities. While she points out that Al Gore tried to get legislation addressing this, capitalists who favor an unregulated marketplace prevailed.

    “It comes as no surprise to learn that human tissue is big business today: $500 million worth and estimated soon to top $1 billion,” wrote Herin in an article on how tissue donors who are moved by altruistic service, rarely realize the huge returns companies will make off their donated of body parts.

    Herin explains that the Musculoskeletal Transplant Foundation (MFT) in Edison, New Jersey – the world’s largest nonprofit tissue bank – earned around $150 million in 2000 by providing tissue to for-profit companies like “Osteotech, which earned $12.3 million in 1999.”

    In her March 2004 article for Harpers, “The Resurrection Men: Scenes from the Cadaver Trade,” Annie Cheney wrote that the sale of body parts is “a matter of some complexity. Like stolen cars and personal computers, cadavers are worth more in pieces than they are intact.”

    Herin added that “Whereas a complete body might bring a mere $1,000 to $4,000, heads go for $550; brains, $500; spines, $1500; and five grams of skin, $803.57.” More when the subject turns to femurs, tendons, veins, and heart valves, the total from a single cadaver can rise to over $200,000.

    The Mastromarino-Nicelli Case

    In what officials are calling a $4.6 million trade in human body parts, Mastromarino paid Nicelli $500 to $1,000 for each cadaver he delivered to the secret operating room in Nicelli’s funeral room. Even after Nicelli sold his funeral operation, he allegedly continued to help Mastromarino and his two assistants, Lee Crucetta and Christopher Aldorasi, sneak into the secret room to perform their ghastly deeds.

    That brazen move is what finally attracted attention to the team and led to New York police detective Patricia O’Brien’s investigation and the arrests.

    What O’Brien found was evidence that plastic pipes had been inserted in place of femurs so that unsuspecting funeral directors would not discover the unlawful body harvesting. Further, Mastromarino and his assistants regularly stuffed their gloves and other evidence of their deeds into the bodies before sewing them back up.

    Charles J. Hynes, the Brooklyn district attorney, said it was “something out of a cheap horror movie.”

    Mastromarino, who sold parts from the cadavers Nicelli provided, netted an average of $7,000 to $8,000 for each. According to the New York Times, prosecutors say his plunder was then “sold to processing companies to be used in transplants, therapies and research.”

    District attorney Hynes told the NYT, “Most disturbing is the fact that no medical precautions were taken to ensure that these transplants were free of disease.”

    Although the FDA is urging reason on the part of those who received tissue from Mastromarino’s company, patients and their attorneys across the country are having the expected strong reactions to the news.

    Orthopedic surgeon in Springfield, Illinois, Stephen, Pineda, M.D., said “This is diabolical… if what has been alleged has been done. What it does to the whole public perspective of bone and all other grafts can be catastrophic.” Even though it is more painful and costly, two of Pineda’s patients are planning to use their own bone for procedures rather than opt for material of questionable origin. “People are worried, [and it is] completely understandable,” Pineda said. “We’ve been fielding 10 calls a day on this from patients.”

    The chief executive officer at the American Association of Tissue Banks, Robert Rigney, said that the number of patients who received implant material from the unethical company is probably quite small. More Rigney points out that regulations do require companies to test and sterilize tissue they process for medical use. That aside, the CEO agreed that the larger influence of the case “is something we’re extremely concerned about.”

    Scope of Misconduct Could Broaden

    Apparently Mastromarino worked with more than one funeral home director and prosecutors are unclear at this point what the larger, ongoing investigation will bring. Hynes said, “We have not any evidence whatsoever at this point that would implicate the funeral directors.”

    Still, documents filed by his office indicate that, “Biomedical was reliant on the funeral homes as a source of supply for his product. Over the past several years, Mastromarino conducted business with numerous funeral directors from several different funeral homes in the Northeast.”

    Kevin Dean, a lawyer from a South Carolina firm that has been quick to sign 85 clients in 19 states concerned about fallout from transplanted material they now carry in their bodies, said, “A lot of these diseases, HIV, hepatitis C, have a long gestation period.”

    For his part, Mastromarino’s defense lawyer, Mario Gallucci said his client “vehemently denies doing anything illegal or wrong,” and followed existing protocol for harvesting donated tissue.

    The courts aren’t so sure and have set the former dentist’s bail at $1.5 million dollars.

    Last updated: 09-Mar-06

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