I'm still in shock after reading this.
Scandal rocks human tissue industry
By TOM HAYS, Associated Press Writer Sun Jun 11, 12:27 PM ET
NEW YORK - As a seasoned "cutter," Lee Cruceta thought he knew when it was safe to harvest human tissue from the dead for transplants to the living — and when it wasn't.
This time, it wasn't.
The man's body stretched out in front of Cruceta in the back room of a Manhattan funeral home after hours one day last summer had yellowish skin. His vacant eyes had the same sickly cast — a sign of jaundice. Cruceta telephoned his boss, Michael Mastromarino, to tell him the bad news: The body had failed inspection.
"We always went by the rule that if you come across a body and you say to yourself, 'I don't want any part of that person in my body,' you rule the case out," Cruceta said.
But Mastromarino, by Cruceta's account, surprised him. Stay put, he said.
The boss came down, checked out the body himself and declared that "everything looked fine."
"I was overruled," Cruceta said.
Out came the surgical tools. The extraction of flesh and bone began.
This is, again, Cruceta's account. He, like Mastromarino, faces criminal charges in a scandal so grotesque that it reads like a real-life sequel to "Frankenstein."
It was Mastromarino who built a business that took from the dead and gave to the living. There are many legitimate businesses that do this, but authorities say Mastromarino's company was not one of them.
Authorities say Biomedical Tissue Services secretly carved up hundreds of cadavers — among them, that of the British-born host of "Masterpiece Theatre," Alistair Cooke — without the families of the deceased knowing about it. They then peddled the pieces on the lucrative non-organ body parts market.
Even scarier: They say BTS doctored paperwork to hide the inconvenient fact that some of the dead were too old and diseased to be donors. As a result, they say, the market was flooded with potentially tainted tissue, and an untold number of patients across the country may have received infections along with their dental implants and hip replacements.
___
To all the world, Michael Mastromarino appeared to be a man of character and accomplishment: College athlete. Oral surgeon. Family man. Author. Multimillionaire.
There were rumors. Cruceta, a 33-year-old nurse who worked closely with Mastromarino for three years, recalled asking his boss if it was true that he'd had run-ins with the authorities.
"He told me it was all lies," he said.
There were several malpractice lawsuits — an occupational hazard for a doctor tackling tough cases, his lawyer says. But dental board records reveal other troubles.
Mastromarino was arrested in July 2000 for being under the influence of drugs and in possession of a hypodermic needle and Demerol, according to the documents. His lawyer, Mario Gallucci, said he became addicted to painkillers while being treated for a back problem.
The criminal charge was eventually dropped, but because his urine tested positive for controlled substances — cocaine and another painkiller, Meperidine — he agreed to surrender his dentistry license for six months and enter rehab. He was later caught practicing without a license — a second offense resulting in a four-year suspension from the profession.
But by then, he had begun another career.
Using his contacts with companies that produce material for dental implants, Mastromarino opened BTS in Fort Lee, N.J., in 2001.
In 2002, Mastromarino sought licensing to do business in New York. As the company's chief officer, he was asked on an application to the state Department of Health whether he "had charges sustained of administrative violations of local, state or federal laws, rules and regulations ... concerning the provisions of health care."
"No," he answered.
The license was granted.
___
Femurs. Tendons. Heart valves. Swatches of skin from the thighs, stomach and back.
The body parts, though no longer of any value to their owners, became big business for Mastromarino. His lawyer said he was among the first in the industry to figure out that one way to meet the high demand for donated human tissue — traditionally procured in the controlled environment of hospitals — was to turn to funeral homes.
Deals were cut with funeral directors in New York City, Rochester, N.Y., Philadelphia and New Jersey: BTS would pay a $1,000 "facility fee" to harvest body parts on their premises.
Three-man teams were dispatched to mortuaries. Two workers would extract the parts. A third would bag them and put them on ice until they could be stored in a freezer at BTS headquarters.
Internal documents from BTS suggest the company had, at least on paper, a strict set of rules for obtaining signed consent for the procedures. A script instructed interviewers to tell family members, "We are about to proceed with the medical social history questionnaire. I have about 40 questions and this interview should take about 20 minutes."
Sample question: "Did the deceased have a tattoo, ear or other body piercing or acupuncture in the past 12 months in which shared instruments are known to have been used?"
Unfortunately, it seems that no questions were asked in hundreds of cases.
Family members have told investigators no one sought permission for body-part donations. The signatures at the bottom of the questionnaires, they said, were forged.
Mastromarino, through his lawyer, has blamed funeral home directors, insisting it was their job to get consent. The directors say it was the other way around.
As early as September 2003, the FDA detected trouble at BTS.
In a routine inspection, an investigator found evidence the company had failed to properly sterilize its equipment, and had no records of how it had disposed of tissue that failed screening for
HIV, hepatitis and syphilis.
But nothing came of it. The FDA backed off after Mastromarino insisted he had voluntarily cleaned up his operation. In a letter, he told officials he would "look forward to your agency revisiting our facility."
___
In November 2004, New York City Police Department Detective Patricia O'Brien responded to a complaint from a funeral director in Brooklyn. The director claimed the parlor's previous owner had stolen down payments for funerals.
But once inside the funeral parlor, she sensed something far more sinister.
The detective was surprised to find an embalming room that looked more like an operating room, with a steel table and bright overhead lights. When she reviewed old files, she found the names of biomedical companies. She later Googled the names and learned each was involved in tissue transplants.
O'Brien had gone into the investigation thinking she was dealing strictly with "a financial situation," she said. "I had no idea. I was shocked."
The NYPD's Major Case Squad widened the investigation, interviewing the relatives of 1,077 dead people whose bodies were harvested for body parts. Only one said permission was given.
Meanwhile, the director of a Denver blood center, Dr. Michael Bauer, had been hired by several tissue banks to review medical charts of donors to make sure tissue was safe.
On the evening of Sept. 28, 2005, while flipping through charts at his desk, he spotted a notation on a woman's chart saying she had chronic bronchitis. As a precaution, he picked up the phone and dialed the number listed for her doctor.
"All I wanted to know was whether the doctor thought that might be an acute infection," meaning something present when she died, Bauer recalled. If so, the germ might still be in her tissue and make it unsuitable for transplantation.
A business answered, one "so unrelated to medicine that it didn't feel right to me."
So he picked up another chart and called another doctor.
Then another. And another.
Each time, no doctor answered. In each case, it appeared the charts were falsified.
"I got through the first 10 and that's when all the hair on the back of my neck stood up," Bauer said.
___
The case, said the prosecutor, is like a "cheap horror movie."
Authorities released photos of exhumed corpses that were boned below the waist like a freshly caught fish. The defendants, they alleged, had made a crude attempt to cover their tracks by sewing PVC pipe back into the bodies in time for open-casket wakes.
Lawsuits filed by implant patients accuse BTS of exposing plaintiffs to hepatitis and other infectious diseases. Families of the dead have sued, too.
Earlier this year, the
Food and Drug Administration shut down BTS amid its own investigation. The agency said it had uncovered evidence the firm failed to screen for contaminated tissue. Parts were recovered from people who had diseases which may have been "exclusionary," an FDA report said.
Death certificates in the company's files, the FDA said, were at odds with those on file with the state: The company's version made people younger than they actually were, and altered the cause and time of the deaths.
Those responsible "were just some irresponsible crooks who were doing this and slipped through the cracks," said Dr. Stuart Youngner, a Case Western Reserve University medical ethicist and head of the ethics committee at Musculoskeletal Transplant Foundation, a large nonprofit tissue bank. "The good tissue banks ... don't do that."
Cruceta is free on $500,000 bond. His name is on papers indicating that he was the one who conducted interviews with family members of the deceased — interviews that authorities say never took place. He insists he signed only because he was instructed to do so; prosecutors don't believe him.
Mastromarino, 42, remains free on $1.5 million bail after pleading not guilty to body stealing, forgery, grand larceny and other counts. Through his lawyer, he refused requests for interviews by The Associated Press.
If convicted, he faces as much as 25 years in prison.
__
Associated Press Writer Adam Goldman and AP Medical Writer Marilynn Marchione contributed to this report.
___
Readers who want to share information or experiences related to this topic may contact reporters by e-mailing [email protected].
Scandal rocks human tissue industry
By TOM HAYS, Associated Press Writer Sun Jun 11, 12:27 PM ET
NEW YORK - As a seasoned "cutter," Lee Cruceta thought he knew when it was safe to harvest human tissue from the dead for transplants to the living — and when it wasn't.
This time, it wasn't.
The man's body stretched out in front of Cruceta in the back room of a Manhattan funeral home after hours one day last summer had yellowish skin. His vacant eyes had the same sickly cast — a sign of jaundice. Cruceta telephoned his boss, Michael Mastromarino, to tell him the bad news: The body had failed inspection.
"We always went by the rule that if you come across a body and you say to yourself, 'I don't want any part of that person in my body,' you rule the case out," Cruceta said.
But Mastromarino, by Cruceta's account, surprised him. Stay put, he said.
The boss came down, checked out the body himself and declared that "everything looked fine."
"I was overruled," Cruceta said.
Out came the surgical tools. The extraction of flesh and bone began.
This is, again, Cruceta's account. He, like Mastromarino, faces criminal charges in a scandal so grotesque that it reads like a real-life sequel to "Frankenstein."
It was Mastromarino who built a business that took from the dead and gave to the living. There are many legitimate businesses that do this, but authorities say Mastromarino's company was not one of them.
Authorities say Biomedical Tissue Services secretly carved up hundreds of cadavers — among them, that of the British-born host of "Masterpiece Theatre," Alistair Cooke — without the families of the deceased knowing about it. They then peddled the pieces on the lucrative non-organ body parts market.
Even scarier: They say BTS doctored paperwork to hide the inconvenient fact that some of the dead were too old and diseased to be donors. As a result, they say, the market was flooded with potentially tainted tissue, and an untold number of patients across the country may have received infections along with their dental implants and hip replacements.
___
To all the world, Michael Mastromarino appeared to be a man of character and accomplishment: College athlete. Oral surgeon. Family man. Author. Multimillionaire.
There were rumors. Cruceta, a 33-year-old nurse who worked closely with Mastromarino for three years, recalled asking his boss if it was true that he'd had run-ins with the authorities.
"He told me it was all lies," he said.
There were several malpractice lawsuits — an occupational hazard for a doctor tackling tough cases, his lawyer says. But dental board records reveal other troubles.
Mastromarino was arrested in July 2000 for being under the influence of drugs and in possession of a hypodermic needle and Demerol, according to the documents. His lawyer, Mario Gallucci, said he became addicted to painkillers while being treated for a back problem.
The criminal charge was eventually dropped, but because his urine tested positive for controlled substances — cocaine and another painkiller, Meperidine — he agreed to surrender his dentistry license for six months and enter rehab. He was later caught practicing without a license — a second offense resulting in a four-year suspension from the profession.
But by then, he had begun another career.
Using his contacts with companies that produce material for dental implants, Mastromarino opened BTS in Fort Lee, N.J., in 2001.
In 2002, Mastromarino sought licensing to do business in New York. As the company's chief officer, he was asked on an application to the state Department of Health whether he "had charges sustained of administrative violations of local, state or federal laws, rules and regulations ... concerning the provisions of health care."
"No," he answered.
The license was granted.
___
Femurs. Tendons. Heart valves. Swatches of skin from the thighs, stomach and back.
The body parts, though no longer of any value to their owners, became big business for Mastromarino. His lawyer said he was among the first in the industry to figure out that one way to meet the high demand for donated human tissue — traditionally procured in the controlled environment of hospitals — was to turn to funeral homes.
Deals were cut with funeral directors in New York City, Rochester, N.Y., Philadelphia and New Jersey: BTS would pay a $1,000 "facility fee" to harvest body parts on their premises.
Three-man teams were dispatched to mortuaries. Two workers would extract the parts. A third would bag them and put them on ice until they could be stored in a freezer at BTS headquarters.
Internal documents from BTS suggest the company had, at least on paper, a strict set of rules for obtaining signed consent for the procedures. A script instructed interviewers to tell family members, "We are about to proceed with the medical social history questionnaire. I have about 40 questions and this interview should take about 20 minutes."
Sample question: "Did the deceased have a tattoo, ear or other body piercing or acupuncture in the past 12 months in which shared instruments are known to have been used?"
Unfortunately, it seems that no questions were asked in hundreds of cases.
Family members have told investigators no one sought permission for body-part donations. The signatures at the bottom of the questionnaires, they said, were forged.
Mastromarino, through his lawyer, has blamed funeral home directors, insisting it was their job to get consent. The directors say it was the other way around.
As early as September 2003, the FDA detected trouble at BTS.
In a routine inspection, an investigator found evidence the company had failed to properly sterilize its equipment, and had no records of how it had disposed of tissue that failed screening for
HIV, hepatitis and syphilis.
But nothing came of it. The FDA backed off after Mastromarino insisted he had voluntarily cleaned up his operation. In a letter, he told officials he would "look forward to your agency revisiting our facility."
___
In November 2004, New York City Police Department Detective Patricia O'Brien responded to a complaint from a funeral director in Brooklyn. The director claimed the parlor's previous owner had stolen down payments for funerals.
But once inside the funeral parlor, she sensed something far more sinister.
The detective was surprised to find an embalming room that looked more like an operating room, with a steel table and bright overhead lights. When she reviewed old files, she found the names of biomedical companies. She later Googled the names and learned each was involved in tissue transplants.
O'Brien had gone into the investigation thinking she was dealing strictly with "a financial situation," she said. "I had no idea. I was shocked."
The NYPD's Major Case Squad widened the investigation, interviewing the relatives of 1,077 dead people whose bodies were harvested for body parts. Only one said permission was given.
Meanwhile, the director of a Denver blood center, Dr. Michael Bauer, had been hired by several tissue banks to review medical charts of donors to make sure tissue was safe.
On the evening of Sept. 28, 2005, while flipping through charts at his desk, he spotted a notation on a woman's chart saying she had chronic bronchitis. As a precaution, he picked up the phone and dialed the number listed for her doctor.
"All I wanted to know was whether the doctor thought that might be an acute infection," meaning something present when she died, Bauer recalled. If so, the germ might still be in her tissue and make it unsuitable for transplantation.
A business answered, one "so unrelated to medicine that it didn't feel right to me."
So he picked up another chart and called another doctor.
Then another. And another.
Each time, no doctor answered. In each case, it appeared the charts were falsified.
"I got through the first 10 and that's when all the hair on the back of my neck stood up," Bauer said.
___
The case, said the prosecutor, is like a "cheap horror movie."
Authorities released photos of exhumed corpses that were boned below the waist like a freshly caught fish. The defendants, they alleged, had made a crude attempt to cover their tracks by sewing PVC pipe back into the bodies in time for open-casket wakes.
Lawsuits filed by implant patients accuse BTS of exposing plaintiffs to hepatitis and other infectious diseases. Families of the dead have sued, too.
Earlier this year, the
Food and Drug Administration shut down BTS amid its own investigation. The agency said it had uncovered evidence the firm failed to screen for contaminated tissue. Parts were recovered from people who had diseases which may have been "exclusionary," an FDA report said.
Death certificates in the company's files, the FDA said, were at odds with those on file with the state: The company's version made people younger than they actually were, and altered the cause and time of the deaths.
Those responsible "were just some irresponsible crooks who were doing this and slipped through the cracks," said Dr. Stuart Youngner, a Case Western Reserve University medical ethicist and head of the ethics committee at Musculoskeletal Transplant Foundation, a large nonprofit tissue bank. "The good tissue banks ... don't do that."
Cruceta is free on $500,000 bond. His name is on papers indicating that he was the one who conducted interviews with family members of the deceased — interviews that authorities say never took place. He insists he signed only because he was instructed to do so; prosecutors don't believe him.
Mastromarino, 42, remains free on $1.5 million bail after pleading not guilty to body stealing, forgery, grand larceny and other counts. Through his lawyer, he refused requests for interviews by The Associated Press.
If convicted, he faces as much as 25 years in prison.
__
Associated Press Writer Adam Goldman and AP Medical Writer Marilynn Marchione contributed to this report.
___
Readers who want to share information or experiences related to this topic may contact reporters by e-mailing [email protected].
