Yourlawyer.com (Untested Body Parts News) http://www.yourlawyer.com/topics/overview/untested_body_parts Fri, 31 Oct 2014 06:45:47 -0400 Fri, 31 Oct 2014 06:45:47 -0400 pixel-app en Second Human Tissue Broker Faces Prison http://www.yourlawyer.com/articles/title/second-human-tissue-broker-faces-prison Tue, 10 Mar 2009 00:00:00 -0400 http://www.yourlawyer.com/articles/title/second-human-tissue-broker-faces-prison A human tissue broker has entered a guilty plea and faces prison time for mail fraud, the News Observer reported.  Philip Joe Guyett, 41, could end up in prison for 60 years for three counts of mail fraud, which arose from claims he created false identities for tissue donors in order to hide their diseases, said the News Observer.  Guyett is scheduled for sentencing on June 1 and remains free on bail pending sentencing.

Guyett, who ran Donor Referral Services, was charged with falsifying blood samples "for tissue he knew would be otherwise rejected for purchase because the presence of infectious or communicable diseases would be detected in the donor blood sample," quoted the News Observer.  Donor Referral Services was shut down in 2006.  Prosecutors said Guyett lied about deceased donor information including age, cause of death, and medical histories, said News Observer, noting that information such as if donors suffered from communicable diseases was also hidden.  Now, donated parts used in over 1.5 million procedures such as knee reconstructions, heart valve repairs, and skin grafts, could be diseased or contain contagions, said the News Observer.

Guyett, who is not believed to be a flight risk, moved to California and claims he did nothing wrong and is being targeted by the government.  It seems, said the News Observer, that the U.S. Food and Drug Administration (FDA) does not maintain clarity around tissue trade procedures and record keeping.

Meanwhile, in September, the Associated Press (AP) broke with news about Michael Mastromarino of New Jersey, who made millions by heading a body trafficking scam that involved stealing hundreds of bodies and selling body parts and tissue to medical companies.  Two brothers—Louis and Gerald Garzone—who ran a funeral home and crematorium involved in the body trafficking scheme admitted they sold cadavers as part of the fraudulent operation.  Tissue and body parts were often diseased, previously rejected, and often left unrefrigerated for days, pending harvesting.

Prior to setting up shop in Raleigh, Guyett pleaded no contest to a felony charge in California for taking payment for human tissue belonging to a university donor program he ran.  This means that Guyett received FDA approval despite having a felony record.  Police also raided a warehouse used by Guyett and discovered three freezers containing human heads and hearts, said the News Observor.  Likewise, Mastromario was also involved in an earlier body theft and selling scam, pleading guilty to enterprise corruption, body stealing, and reckless endangerment in New York where he was sentenced to 18 to 54 years in prison.

Like Mastromario, Guyett collaborated with funeral home operators, paying finder fees for information on potential donors, with one manager admitting to allowing Guyett to harvest bone, ligaments, tendons, and skin from cadavers under unsterilized conditions.

"Philip Guyett chose to tell lies in a matter as sensitive as the implantation of tissue into medical patients across the country, all to make a quick buck.  This flagrant and selfish disregard for the safety and health of the citizens of this country simply will not be tolerated," said U.S. Attorney George Holding, wrote Cleveland.com.  Regardless, Guyett continues to remain free on bail.

Some patients have voiced concerns, including one woman who and has suffered from unexplained rashes, weight loss, and poor health ever since undergoing bone graft surgery, said Cleveland.com.

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Body Parts Scam Tops 450 Cases http://www.yourlawyer.com/articles/title/body-parts-scam-tops-450-cases Tue, 15 May 2007 00:00:00 -0400 http://www.yourlawyer.com/articles/title/body-parts-scam-tops-450-cases More than 450 people nationwide now claim they received illegally obtained and possibly diseased body parts from a New Jersey-based scheme, according to court documents.

The Food and Drug Administration has said it's concerned that the bone and tissue could be infected with the AIDS virus, syphilis and hepatitis, but the risk of infection is small.

The FDA, which did not return requests for comment, has not said whether any patients have ailments linked to the tissue, nor has it revealed how many people received it.

However, a document filed in a South Dakota lawsuit states that 13 plaintiffs nationwide claim they have contracted a disease.

The South Dakota case was brought by Charles Geigle of Oliver County, N.D., who claims he received transplanted bone tissue that might be infected.

He had back surgery April 30, 2004, at Sioux Valley Hospital in Sioux Falls, according to his complaint filed in U.S. District Court.

Defendants in the lawsuit, which seeks class-action status, have asked for a delay so they can argue that it should be transferred to the Judicial Panel on Multidistrict Litigation, which coordinates identical federal civil lawsuits into one jurisdiction.

Of the 451 cases filed so far, 189 are in federal courts and 134 of them have been transferred to the panel, court documents state. Two other South Dakota cases are among those that have been transferred.

"The need for coordination of this national litigation is compelling. The multiple proposed classes, as well as the individual actions, are overlapping. The complaints contain virtually identical allegations in many cases," according to one document in Geigle's case.

He received a letter in December 2005 from a doctor telling him the bone tissue he received might have been illegally acquired and that he could be at risk of getting a disease.

The supplier was Biomedical Tissue Services, a now-defunct Fort Lee, N.J., company owned by former dentist Michael Mastromarino, who made millions of dollars from the scheme, prosecutors have said.

He and three other men are accused of secretly removing skin, bone and other parts from up to 1,000 bodies from funeral homes without the families' permission.

"When a funeral was scheduled to be 'open casket,' harvested bone taken from the deceased was replaced with PVC pipe and other objects so the bodies would still appear normal during the funeral proceedings," court documents state.

The men also changed the names of the donors, medical records, death certificates and other information "in order to conceal the lifestyle and medical history of the donors," the documents said.

BTS supplied bone, skin and tendons to various processors that in turn provided the body parts to distributors for common procedures such as dental implants and hip replacements. Some of the tissue came from bodies that were not eligible to be donors because of age, disease or illness, according to Geigle's lawsuit.

Because of that, Geigle said he and perhaps thousands of others now live in fear they or their spouses have been exposed to a deadly disease. He seeks more than $5 million in damages for patients who received BTS tissue from 2002 to 2005.

Geigle received bone that was processed and packaged by Regeneration Technologies Inc., a Delaware corporation, and distributed by SpinalGraft Technologies of Tennessee, a division of Minneapolis-based distributor Medtronic Inc. all of which are listed as defendants.

The FDA ordered BTS to stop operating because of the serious nature of the violations and ordered a recall of all products, which the other defendants complied with, the lawsuit states.

The FDA and Centers for Disease Control also urged people who received BTS tissue be tested for infectious disease.

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Human tissue bank issues recall http://www.yourlawyer.com/articles/title/human-tissue-bank-issues-recall Thu, 23 Nov 2006 00:00:00 -0500 http://www.yourlawyer.com/articles/title/human-tissue-bank-issues-recall
A hospital reported the bacterial infection in September to the Centers for Disease Control and Prevention, which launched an intense, nationwide effort to search for more cases.

None have been found, but the incident shows the dangers that patients face when receiving such tissue and how dependent they are on the companies supplying it to ensure its safety.

A three-month investigation by The Associated Press, published in June, detailed problems that can arise from cadaver tissue used in more than a million medical procedures each year in the United States, especially knee and back surgeries.

Two scandals involving tissue suppliers have occurred in the last year, and the federal Food and Drug Administration has formed a task force to look for regulatory gaps that threaten safety.

The new case involves a company that many health officials and tissue company executives regard as an industry leader and standard-bearer: Musculoskeletal Transplant Foundation, or MTF, of Edison, N.J. In more than 20 years of supplying 2.7 million pieces of bone, skin and other tissues, this is the company's first reported infection, said a spokeswoman, Cindy Gordon.

In April, MTF noticed an increase in the number of tissues rejected for not passing sterility tests at its Jessup, Pa., processing plant one of two such facilities it operates. Tissues were quarantined and about 150 that failed tests were destroyed, Gordon said.

In September, the CDC notified the company that an unusual infection had been reported in a Minnesota patient who received MTF-supplied tissue during surgery to fix a torn ligament a week earlier. Fluid from the patient's knee joint grew Chryseobacterium meningosepticum a germ never previously linked to tissue or organ transplants, said Dr. Arjun Srinivasan of the CDC.

"It's a very rare cause of infections in the health care setting," so the agency asked more than 1,000 public health officials, infectious-disease doctors, microbiologists and orthopedic surgeons around the country to search for additional cases, he said.

Five other people had received tissue from the same donor and none developed infections. MTF retrieved a sixth sample, and tests at CDC revealed it had the same bacteria as the Minnesota patient.

As a precaution, MTF decided to go back six months before the Minnesota case to February and try to retrieve as many of the 4,700 tissues supplied by the Jessup facility as possible, Gordon said. About 2,300 had already been implanted, and no other infections have been reported, she said. Hospitals have been asked to send back the remaining 2,400.

"This was not something that the FDA or the CDC asked us to do," but a voluntary action to ensure patient safety, Gordon said.

The Minnesota patient made a full recovery after antibiotic treatment and still has the cadaver tendon, said Joel Osborne, MTF vice president of quality assurance and regulatory affairs. MTF would not identify the hospital or give details about the patient.

Srinivasan praised the company's handling of the case.

"They've been very aggressive working with us" to try to locate the source of the germ, which may have been introduced during processing rather than originating with the donor, he said.

FDA spokeswoman Julie Zawisza emphasized that this case is not like the two earlier scandals in the human tissue industry, "where the suitability of the human donors was called into question." She said MTF is cooperating with the FDA on the case.]]>
Embalmer Implicates Partner in Documents http://www.yourlawyer.com/articles/title/embalmer-implicates-partner-in-documents Thu, 28 Sep 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/embalmer-implicates-partner-in-documents
The papers, obtained Thursday by The Associated Press, detail a long statement given by Joseph Nicelli before he was charged in a plot to secretly remove skin, bone and other parts from hundreds of bodies from funeral homes in New York City, Rochester, N.Y., Philadelphia and New Jersey.

Nicelli implicated Michael Mastromarino, a former oral surgeon, as the mastermind of a scheme that made millions of dollars by selling the stolen tissue to biomedical companies that supply material for procedures including dental implants and hip replacements. Among the looted bodies was that of "Masterpiece Theatre" host Alistair Cooke, who died in 2004.

During a failed bid in 2005 to head off his arrest and become a cooperator, Nicelli said that after collecting bodies for embalming or cremation, he would divert them to Mastromarino to carve up without families' permission, a police report said.

Nicelli, 50, "stated maybe he spoke with two families about a possible donation, but all other extractions were done without consent," the report said.

He further claimed he overheard Mastromarino describing how on paperwork he "would change a donor's criteria such as age," the report added. "He would make them younger, which would be more attractive to the companies accepting the tissue."

Mastromarino also changed times of death to make the parts appear fresher and extracted them from cancer victims without telling the tissue banks, some of which consider the disease a disqualifying condition, Nicelli told investigators, according to the report.

Nicelli said that when he questioned the doctored paperwork, Mastromarino told him, "Don't worry about it."

Part of Nicelli's job was to try to restore bodies to so that grieving families wouldn't notice bones had been removed, he said. In one instance in 2003, a daughter complained that "her father looked shorter in the coffin," he said.

Mastromarino has denied any wrongdoing, saying it was the funeral directors' role not his to obtain consent and medical histories of the dead and he took their word for it that the bodies were suitable for harvesting.

Nicelli's statement "is consistent with what Dr. Mastromarino has been saying all along," Mastromarino's attorney, Mario Gallucci, said Thursday.

A telephone call to Nicelli's attorney was not immediately returned Thursday.

Mastromarino, owner of Biomedical Tissue Services of Fort Lee, N.J.; Nicelli; and two so-called "cutters" were charged in February with body stealing, unlawful dissection and forgery in a case a district attorney called "something out of a cheap horror movie." All the defendants pleaded not guilty before being released on bail.

At the time, prosecutors said they had unearthed evidence that death certificates and other paperwork were falsified. In Cooke's case, his age was recorded as 85 rather than 95 and the cause of death was listed as heart attack instead of lung cancer that had spread to his bones.

The defendants are scheduled to appear in court next week. Mastromarino's attorney said prosecutors have notified the defense they will ask for a delay in the case because a grand jury is hearing new evidence that could result in more charges.]]>
Patients given transplants using plundered body parts http://www.yourlawyer.com/articles/title/patients-given-transplants-using-plundered-body-parts Sat, 23 Sep 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/patients-given-transplants-using-plundered-body-parts
The body of veteran BBC broadcaster Alistair Cooke was one of more than 1,000 allegedly stolen from funeral parlours by an American mafia ring and sold for use in bone grafts.

It has now emerged that 25 UK hospitals bought tissue that had been snatched from corpses - prompting fears that patients could have been exposed to a range of diseases.

There are fears that the horrific practice could have exposed British patients to HIV, syphilis or other illnesses transmitted through contaminated body parts.

The scandal is reminiscent of earlier scares associated with transfusions and transplants.

Two years ago, thousands of people were told that they might have been infected with the human form of bovine spongiform encephalopathy through contaminated blood plasma products. There have also been scares about HIV and hepatitis C infection from blood products.

The Medicines and Healthcare Products Regulatory Agency (MHRA) on Thursday named the 25 hospitals where potentially contaminated human body parts were grafted into patients. It revealed that 82 pieces of bone had been bought to be used in procedures such as hip and bone operations and were distributed to the hospitals by a Swindon-based firm called Plus Orthopaedics.

A spokesperson for the health watchdog said the risk of catching an infection from the stolen bones was "negligible" as the bones had been sterilised. However, some of the affected patients have been contacted and offered screening for disease.

The scandal first surfaced last October when it was revealed that the New Jersey-based company Biomedical Tissue Services (BTS) had been selling bones, ligaments and skin for use in transplants allegedly removed illegally from corpses. Bone is said to have been taken illegally from American corpses at funeral parlours without the deceased’s prior consent and without the necessary checks to make sure the bodies were free of disease.

Cooke, whose Radio 4 programme Letter From America ran for 58 years, died from lung cancer aged 95 last December. His bones were cut out and sent to BTS before he was cremated.

BTS boss Michael Mastromarino, who faces body harvesting charges, is said to have paid £500 per corpse. The company, which has been shut down, supplied bones and other body parts to the NHS.

Many of the bones supplied by BTS were recalled after its scavenging was uncovered. The US Food and Drug Administration has warned that many patients could have been exposed to HIV and other diseased, but also insists the risk of infection is minimal]]>
U.K. Probes Use of Stolen Body Parts http://www.yourlawyer.com/articles/title/uk-probes-use-of-stolen-body-parts Thu, 21 Sep 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/uk-probes-use-of-stolen-body-parts
The Medicines and Healthcare Products Regulatory Agency, which oversees the safety of medicines and medical devices, on Wednesday released a list of 25 hospitals in the U.K. where patients may have received tainted bone material.

"Affected tissue has been recalled, but up to 82 units of affected bone graft material may have been implanted into a small number of patients," said the agency in a statement.

Bone material is typically used as filler in orthopedic surgery, such as hip replacement operations or jaw surgery. Before being used in medical procedures, bones are subjected to chemical processing and sterilization procedures. The risk to patients is thought to be minimal, according to the agency.

Hospitals were alerted of the possible breach of procedure last October, but the information was only released publicly on Wednesday in response to a Freedom of Information request filed by the British Broadcasting Corp.

It is the latest development in a case that dates back to 2004, when the body of veteran BBC broadcaster Alistair Cooke was one of more than a thousand allegedly stolen by a ring of dealers in the U.S., who falsified the origins before selling body parts for transplantation.

Last year, Biomedical Tissue Services, a U.S.-based tissue procurement company at the center of the scandal, was accused of failing to adequately document its human tissue donors. It was said to have used bodies obtained illegally, without consent, and with falsified documents.

The Royal National Orthopedic Hospital, one of the hospitals receiving questionable bone material, issued a statement saying that "it would not be appropriate to contact patients," because risk was negligible. "Any adverse reactions would in any case be picked up as part of the routine follow-up of patients," the statement said.

Some ethicists, however, said that as a matter of standard practice, patients have the right to be informed when they have been potentially exposed to risk. Certain organisms, including the prion that causes Creutzfeldt-Jakob Disease or Mad Cow Disease are extremely resistant to sterilization procedures and could be transmitted by tissue transplants.

There are no laws governing the import and export of human body parts into the U.K. Though such laws exist to prohibit the transport of organs between countries, there is no comparable regulation for body parts.]]>
Bogus records raise more fears in tissue trade http://www.yourlawyer.com/articles/title/bogus-records-raise-more-fears-in-tissue-trade Mon, 18 Sep 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/bogus-records-raise-more-fears-in-tissue-trade The medical records that accompanied the body of “Masterpiece Theatre” host Alistair Cooke were wrong in just about every possible way.

His name was misspelled. His birthdate was off by 10 years. His Social Security number wasn’t even close. Also wrong were the name of his doctor and the time and cause of his death.

There was even a bogus name and phone number for a family member who supposedly agreed to donate the 95-year-old celebrity’s body parts for tissue transplants.

The records, obtained by The Associated Press, provide the most in-depth look so far into the case of the famed TV personality, and raise more questions about the safety of the cadaver tissue industry: Why didn’t the tissue processor that acquired Cooke’s body parts catch any of the bogus entries?

“It’s deeply disturbing,” said Susan Cooke Kittredge, Cooke’s daughter. “It throws out any kind of faith I had in the system. It’s so broken. It’s horrible to me that this wasn’t caught.”

Donated cadaver tissue is used in more than a million procedures a year in the United States to repair bad backs, fix ailing knees and replace heart valves. Most of these operations are safe and do tremendous good, but tissue that has not been treated properly or is taken from unscreened donors can infect a patient with hepatitis, HIV and other potentially deadly infections.

Processor denies wrongdoing

Tissue processor Regeneration Technologies Inc. of Alachua, Fla., declined to discuss Cooke’s medical records but has said the company did nothing wrong.

The company says it relies on the suppliers of cadaver tissue to “perform a risk assessment on every potential donor, interview family members and evaluate the donor’s medical records.”

In this case, Regeneration and four other processors put their faith in Biomedical Tissue Services of Fort Lee, N.J., which was shut down earlier this year and is at the center of a national scandal involving the theft of cadaver tissue. Michael Mastromarino, former chief executive of Biomedical Tissue Services, helped prepare the records for Cooke and others whose bodies were sent to be processed.

The Food and Drug Administration says companies like Regeneration are responsible for ensuring their business partners comply with federal guidelines.

The records for Cooke show Regeneration received the arms and legs. Previously, it was believed that only Cooke’s legs were taken and provided for thousands of dollars to Regeneration. Cooke’s pelvis and other tissue were also removed, but it’s not clear where those parts were sent.

Regeneration says Cooke’s tissue was never implanted, but about 10,000 pieces from BTS did wind up in people landing Regeneration and several other companies in civil court.

In an undated letter Regeneration Chairman Brian Hutchison sent to Cooke’s daughter, the company said it performed many “quality control procedures, and in this case our procedures prevented distribution as they are designed to do.”

But it was a Colorado doctor who discovered the suspected fraud, notifying LifeCell Corp., another tissue processor that received parts from Biomedical Tissue.

LifeCell sounded the alarm and then informed the FDA, which led to a voluntary recall of the tissue nearly a year ago and raising serious questions about the safety practices within the industry.

Court documents show Regeneration shipped a total of 19,446 pieces of tissue that Biomedical Tissue Services provided.

“They clearly did not have any intention of bothering to verify the authenticity of the documents,” Kittredge said. “If they had made one phone call to me or this spurious doctor, it would have been caught immediately.”

Cooke's daughter never consented

Kittredge, who has not sued any of the tissue processors involved in the scandal, says she never consented to have her father’s body parts donated despite that claim in her father’s records. The papers were signed by Mastromarino and employee Chris Aldorasi.

The documents say that a person named “Susan Quint” of the Bronx identified as Cooke’s daughter consented to giving BTS the body parts. But Kittredge is Cooke’s only daughter, and she lives in Vermont, where she is a minister.

In addition, Cooke died of lung cancer, but the records list his cause of death as “cardiopulmonary arrest.” He was 95. BTS said he was 85.

The time the body was recovered was also fudged. Cooke died just after midnight March 30, 2004, but BTS lists it as 6:45 a.m. making the 9:30 p.m. recovery time look shorter and the body fresher and more suitable for processing.

Mastromarino’s lawyer said his client didn’t do anything wrong and pinned the blame on New York Mortuary Service, where Cooke’s tissue was recovered. The mortuary service’s funeral director, Timothy O’Brien, has already pleaded guilty for his role in the scheme.

Aldorasi’s lawyer says he can’t comment on the records because he hasn’t seen them.

Mastromarino, Aldorasi and two other BTS employees were charged in an indictment February in a Brooklyn court. All four have pleaded not guilty to charges of enterprise corruption, body stealing and opening graves, unlawful dissection, forgery and other counts.

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Patients urged to get tested after latest body parts scandal http://www.yourlawyer.com/articles/title/patients-urged-to-get-tested-after-latest-body-parts-scandal Fri, 01 Sep 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/patients-urged-to-get-tested-after-latest-body-parts-scandal
How much risk do they face?

Answering that is tough because federal officials will not say how many people around the country had already received tissue by the time recalls were announced. Or which types of tissue were involved and how it was treated.

Patients may not even be aware they received cadaver tissue, which is used for everything from back surgery to dental implants. Not all doctors even tell their patients they'll be getting donated human tissue. Doctors themselves often don't know where the tissue came from especially because it often is procured, tested and treated by different companies.

However, two steps can give patients a good idea of their potential risks, experts say:
  • Pressing your doctor for details on the companies that supplied your tissue and whether any are involved in the recalls.
  • Getting the infectious disease tests that health officials recommend HIV, hepatitis B and C, and syphilis.
"If they're six months out (from the transplant) and they test negative, they don't have to worry," said Dr. L. Clifford McDonald, an infectious disease specialist at the federal Centers for Disease Control and Prevention.

Chances are good that an infection would have taken hold by then, or at least shown up in blood tests, he said.

On Aug. 18, the U.S. Food and Drug Administration shut down Philip Guyett Jr. and Donor Referral Services of Raleigh, N.C., citing "serious deficiencies" in manufacturing practices. In some cases, records did not match what official death certificates showed and left out details like a donor's history of cancer or drug use that may have made the donor's tissue ineligible for transplant, the FDA's order says.

On Wednesday, the FDA urged doctors to contact patients who received tissue from the firm, saying that additional information from the ongoing investigation "has heightened our concern" about the situation.

Companies voluntarily recalling tissues supplied by the Raleigh firm are Alamo Tissue Services of San Antonio, Texas; Lost Mountain Tissue Bank of Kennesaw, Ga.; TissueNet of Orlando, Fla.; and US Tissue and Cell of Cincinnati, Ohio. (AlloSource of Centennial, Colo., which acquired some of US Tissue's assets in March, is handling US Tissue's recall).
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FDA Weighs Oversight of Body Parts Trade http://www.yourlawyer.com/articles/title/fda-weighs-oversight-of-body-parts-trade Wed, 30 Aug 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/fda-weighs-oversight-of-body-parts-trade The second body parts scandal in a year has federal health officials asking if they need to strengthen their oversight of the trade in human tissues and organs.

The Food and Drug Administration said Wednesday it has formed a task force to study its regulation of the industry, including the effectiveness of new rules implemented just last year. Since then, investigators have discovered at least two companies that collected human body parts for medical use without following federal guidelines.

"The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products," said Dr. Jesse Goodman, director of the FDA center that oversees human tissue.

Earlier this month, the FDA shut down Donor Referral Services of Raleigh, N.C., saying the company had "serious deficiencies" in its processing, donor screening and record-keeping. The FDA said the records on at least five donors did not match their death certificates, some of which listed cancer and drug use that might have made them ineligible as tissue sources. Company owner Philip Guyett has denied any wrongdoing.

The closure came after Biomedical Tissue Services, a now-defunct New Jersey company, was accused of failing to gain consent to take bones, tendons, ligaments, skin and other tissue from cadavers. The company's owner and three others have pleaded not guilty to the charges against them.

Most tissue companies follow the law, the FDA said. But the regulatory agency wants to study whether it needs to step up its oversight to ensure all companies act to protect recipients of donated tissue from communicable diseases.

Improper testing or treatment of donated tissues can lead to infections like hepatitis.

Donated cadaver tissue is used in more than 1.3 million medical procedures a year, ranging from knee repairs and spine surgeries to burn care and even dental work.

A three-month investigation by The Associated Press, published in June, documented the potential risks to the public from this little-regulated industry.

The FDA relies on broad, catchall language for much of its regulation. An industry group, the American Association of Tissue Banks, has more specific and strict rules, but tissue businesses are not required to seek the association's accreditation or comply with its standards.

The FDA's task force will be an internal review involving agency employees no outside experts, said Robert Rigney, executive director of the association, who was briefed on the plans.

"We have not been asked to participate, although we would welcome an opportunity," he said.

An FDA spokesman could not immediately say why the task force didn't include anyone from outside the agency.

Earlier this month, the tissue bank association adopted a new rule requiring its members to provide a list of all tissue businesses they work with, including tissue procurers. It also allows the association to inspect and audit those businesses even if they are not association members themselves. The action was recommended by a task force the association formed in the wake of the scandal involving the New Jersey company. That company was not an association member.

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Industry Sees 2nd Tissue Scandal in Year http://www.yourlawyer.com/articles/title/industry-sees-2nd-tissue-scandal-in-year Mon, 28 Aug 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/industry-sees-2nd-tissue-scandal-in-year
Federal officials shut down this flesh-and-bone prospector in Raleigh, N.C., earlier this month, saying his products posed a danger to public health.

By then, he had supplied hundreds of tissues for knee repairs, spine surgeries and other medical procedures around the nation, many of them allegedly procured in an unsterile funeral home embalming room.

Despite his conviction, he twice was able to register companies with the U.S. Food and Drug Administration to provide tissue for transplants.

"Here's a convicted felon who could pretty much go anywhere in the country and open a tissue recovery agency," complained one tissue banker who refused to work with him, Ken Richardson of Nevada Donor Network. "That illustrates some of the problems with our existing regulatory structure."

Guyett, 38, denies any wrongdoing, and insists he went out of business on his own accord some months back. No one yet knows how many people received tissue he supplied or what risks they may face. Companies have been quietly recalling his products from doctors and hospitals since early July.

Many who work in this field are outraged by the problem, the second big tissue scandal in a year, following one that led to criminal charges in New Jersey. But a three-month investigation by The Associated Press, published in June, found that lax oversight of the billion-dollar industry allows such situations to occur and puts the public at risk.

Donated cadaver tissue is used in more than a million procedures each year, and most of these operations do a lot of good.

But poor testing or treatment can lead to infections like hepatitis and even death. Oversight is up to the FDA, but it relies on broad-brush rules. The American Association of Tissue Banks has strict standards, but the FDA does not require companies to join or to abide by these rules.

"In this business what really rules is: Do you have the goods? Can you give the body parts that I need? If you have a sketchy background, that doesn't really make a difference. People just want to get the parts," said Annie Cheney, author of the book "Body Brokers."

Time after time, the smooth-talking, affable Guyett found ways to get the goods.

"Our mission," he said when pitching tissue donation to residents of a suburban Raleigh retirement home last year, "is to give donors and their families an informed choice when considering making an anatomical gift." In a video of the May 2005 talk, his audience, which included funeral directors, is seen applauding at times.

How and when Guyett got into the business isn't clear. Parts of the resume he gave the group sponsoring his talk do not match what others say. Like being an anatomy instructor at Mount San Antonio College in Walnut, Calif., from 1997 to 1999. The school has no record of an instructor by that name, said human resources clerk Nerissa Uiagalelei.

The resume also lists Guyett as a "forensic specialist" from 1993 to 1997 in the Clark County, Nev., coroner's office. But that title isn't used at the Las Vegas agency and Guyett only volunteered there some weekends between 1994 and 1996 and was not a paid employee, said Coroner Michael Murphy.

Guyett's "affiliation with our office appears to be exaggerated," he added.

Undisputed, though, is that Guyett was an administrator at the willed body program at Western University in Pomona, Calif., in 1999 when police charged him with selling a cadaver to another school and keeping the $1,100 payment.

He pleaded no contest to a felony, embezzlement; other charges, unlawful removal of human remains and grand theft, were dropped, said Jane Robison, spokeswoman for the Los Angeles County District Attorney's office. He was fined and sentenced in April 2000, performed six months of community service highway cleanup and was given three years' probation.

By the fall of 2003, he was in Las Vegas, registering Donor Referral Services with the FDA as a human tissue business. Soon afterward, Missouri police discovered human limbs in a leaky FedEx container Guyett's company had shipped to a Missouri man who provides body parts for medical research and teaching. Much ado about nothing, Guyett told the St. Louis Post-Dispatch.

"Boxes break," the newspaper quoted him as saying. "If a box leaks and it's carrying a cornea, no one freaks."

At the time, Guyett and his second wife, Jennifer, lived in Henderson, a Las Vegas suburb, in a four-bedroom home bought in November 2002 for $258,676.

But business apparently was slow. Officials at virtually every funeral home and crematorium in Las Vegas told the AP they didn't do business with him, or even know him.

By the summer of 2004, Guyett was planning to relocate.

Larry Parker, president of Cremation Society of the Carolinas, a Raleigh funeral home, got a call from Guyett, whom he didn't know, saying he was thinking of moving to be closer to the East Coast tissue banks he worked with.

By November 2004, Guyett had sold the Nevada house, with a profit of nearly $200,000, moved to Raleigh, and was paying Parker $1,000 for each successful donor family he referred and use of his embalming room.

"If they said, 'yes,' that's as far as we went," and Guyett would take over, interviewing the family about the donor's medical history and suitability for transplant and obtaining consent, said Parker, who added that he had never been involved in tissue procurement before but became convinced "there's a terrific need out there."

Guyett tried to drum up business at a seminar sponsored by the Funeral Consumers Alliance of the Triangle and the American Association of Retired Persons; this was the gathering captured on video. Guyett played a funeral director in a skit involving a family arguing over whether to donate a dead father's organs and tissues. Parker narrated the skit.

Guyett also pursued a related business recycling titanium screws, implants and pins left over after cremation. Randy Bright, owner of Covenant Cremation Service in Wake Forest, N.C., was among those who let Guyett take these materials.

"There's no money exchanged at all," Bright said. "What are we going to do with them? We had no idea. It didn't cost the family or anything for that. And we didn't really have a way to dispose of them. It sounded like a good situation."

When Guyett proposed expanding the recyling business through the Cremation Association of North America, he made business claims that have come into question. He gave Jack Springer, the group's executive director, a list of 10 mortuaries that he said he dealt with regularly. Reached by AP, at least two Miller-Jones of Hemet, Calif., and Serenity Mortuary Service of Phoenix said they didn't know Guyett or his company.

"He had never done anything with us," said Timothy Hassett, owner of Serenity.

Likewise, Mike McGhee, general manager of Forbis & Dick Funeral Service in Greensboro, N.C., said he had no idea why Guyett listed his company as one of his business affiliates.

"I have been here for 27 years, and I can assure you that our firm has never had any dealings with this gentleman," he said. "This is abhorrent and repugnant to me," McGhee said of the concerns about Guyett. "I intend to find out why he used our name."

Guyett even claimed a relationship with the federal government, telling the seminar crowd: "Over the last six months, we've recovered over 1,000 tissue specimens that were sent to the National Cancer Institute for research. Eighty percent of those donors were also accepted for transplant allografts."

A cancer institute spokeswoman said neither Guyett nor his firm has been a supplier.

The FDA closed Guyett's Raleigh operations down on Aug. 18.

According to the FDA's order, Guyett altered paperwork on the health history and age of at least five dead donors, eliminating mention of factors like cancer and drug use that might make them ineligible.

In a brief interview last week at his two-story brick home in Wakefield Plantation, a new and upscale subdivision in north Raleigh, the goateed, slightly balding Guyett said the FDA did not force him out, and that he had done nothing wrong.

"I closed on my own free will to pursue other ventures. I'm out of the tissue recovery business as of December," Guyett said.

Yet as recently as three months ago, Guyett repeated requests to David Campbell, owner of Cape Fear Crematory in Stedman, N.C., to use his facility on the outskirts of the Fort Bragg Army base to harvest tissues and medical implants. As he had in the past, Campbell declined, and said, "I'm kind of glad from what I'm seeing in the press these days."

The Guyett case follows that of Biomedical Tissue Services, a now-defunct New Jersey company accused of plundering corpses for tissue without families' permission, including the body of "Masterpiece Theatre" host Alistair Cooke. A former dentist, Michael Mastromarino, and three others face charges in that scandal.

That company, like Guyett's, was not accredited by the tissue bank association. There are more under-the-radar tissue brokers out there than the FDA would like to think, said Areta Kupchyk, a former FDA attorney who helped write tissue regulations and consults with tissue companies.

"He's probably an example of many small-timers around the country," Kupchyk said of Guyett. "They're the ones that are the most dangerous. They get a small niche and they can cause a lot of trouble."]]>
Body-part harvesting company must close http://www.yourlawyer.com/articles/title/-body-part-harvesting-company-must-close Fri, 18 Aug 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/-body-part-harvesting-company-must-close
The Food and Drug Administration said it ordered Donor Referral Services to cease all manufacturing and to retain all cadaver tissues, following June inspections of the company in Raleigh, N.C. The company collected tissue for other firms that later processed it for transplantation.

The inspections found "serious deficiencies" in how the company screened donors and kept records, the FDA said. The FDA said it does not know of any cases of infection in people who received donor tissue harvested by the company.

All tissue products the company took from cadavers have been recalled, although some already have been transplanted, FDA spokesman Paul Richards said. It wasn't immediately clear how many people received tissue harvested by the company.

The FDA believes the risk of infection is low, but that the actual risk is unknown, Richards said. Patients with questions should contact their doctors, he said.

In the case of at least five cadavers, the company and its owner, Philip Guyett, altered paperwork on the health history and age of those donors, the FDA said. For one, Guyett listed in paperwork various reasons for the death of the donor but failed to log correctly that the person had died of cancer, with intravenous drug use a contributing factor, the FDA said. IV drug use is associated with elevated risk for diseases like HIV/AIDS and hepatitis.

"Allowing the firm to continue to manufacture would present a danger to public health by increasing the risk of communicable disease transmission," said Margaret O'K. Glavin, associate commissioner of the FDA's office of regulatory affairs.

A man who answered a telephone listed in Philip Guyett's name in the Raleigh area told The Associated Press he was no longer connected with Donor Referral Services before hanging up.

A Philip J. Guyett Jr. ran for five years in the 1990s the willed body program at an osteopathic college in Pomona, Calif. He was arrested in 1999 for allegedly selling a cadaver to another school and keeping the $1,100 payment. At that time, police raided a warehouse he used and found three freezers containing human heads and hearts. He later pleaded not guilty.

That Guyett later incorporated a Donor Referral Services Inc. in Las Vegas. It wasn't immediately clear if he is the same person involved in Friday's FDA action.

The action comes as the tissue industry struggles to recover from the biggest scandal in its history, involving Biomedical Tissue Services, a now-defunct New Jersey company accused of plundering corpses for body parts without family members' permission.

Among those whose corpses were scavenged was "Masterpiece Theatre" host Alistair Cooke. A former dentist, Michael Mastromarino, and three others face charges in that scandal. Investigators unearthed evidence that death certificates and other paperwork were doctored.

Neither Guyett nor his company belong to the American Association of Tissue Banks, a professional organization that sets strict standards for how tissue is recovered and processed, said the association's president, James Forsell.

More than 1.3 million Americans each year have operations or procedures that use bone, skin, corneas or other types of tissue from donated cadavers. These range from dental implants using ground bone to knee ligament and spine repairs.

The vast majority of cases turn out fine, but serious infections and even death can occur if the tissue has been poorly tested or improperly processed to kill germs.]]>
Probe urges Hong Kong help over China organs http://www.yourlawyer.com/articles/title/probe-urges-hong-kong-help-over-china-organs Mon, 17 Jul 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/probe-urges-hong-kong-help-over-china-organs
Lawyers launched the investigation after the wife of a Chinese surgeon claimed her husband had been asked to remove organs from a member of the outlawed Falungong sect.

The report of their investigation, published in Ottawa last week, concluded that while it had been difficult to obtain evidence backing her claims, there was no evidence to dispute them.

The lawyers have since sought support from governments around the world, including Hong Kong.

"We don't expect China to come out and admit this is happening but if we can get people to pressure authorities into doing something, then that's a positive move," said one of the investigative lawyers on Monday.

"Hong Kong shares such an affinity with China that we believe a few words from people here would be able to achieve a lot of change," one of the lawyers said.

China denied it had allowed tranplants from unwilling donors many of whom were said to have died and then been cremated, according to the report.

The report said it was more than likely that the grisly trades were taking place and that "substantial amounts of money are changing hands."

It pointed to evidence provided by jailed Falungong activists and disparities between the numbers of transplants and the number of executions, whose victims have been the traditional source of transplantable organs.

The majority of victims, it said, were living Falungong followers. Thousands of members of the sect, which China has banned as evil, have been jailed for their views.]]>
Cadaver scandal has local tissue recipients worried http://www.yourlawyer.com/articles/title/cadaver-scandal-has-local-tissue-recipients-worried Sun, 02 Jul 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/cadaver-scandal-has-local-tissue-recipients-worried
Once inside the funeral parlor, O'Brien sensed something worse. She 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 with a financial situation, but instead stumbled upon a scandal so grotesque it reads like a real-life sequel to "Frankenstein."

Local connection

The fall-out from a scheme in which a New Jersey tissue-recovery firm that harvested body parts from cadavers that were too old or too sick has stretched thousands of miles, reaching halfway across the country to Naperville.

By bribing funeral directors and forging documents, authorities charge that Biomedical Tissue Services stole tendons, bones, heart valves and other tissues then sold them for use in patients, some of whom developed health complications from the tainted tissue.

One of those patients was Naperville resident Richard Castello, 55. Castello had a simple hernia procedure in February 2005 that turned horribly wrong due to a skin graft reinforcement with diseased tissue from BTS.

Castello developed severe infections from the tissue, necessitating its removal.

"It's just been horrific," Castello said.

By the time a letter from the University of Chicago Hospitals where he received the skin graft reached Castello a year later, the afflicted tissue had mixed with other tissue.

"It was fused into me, especially after a year," Castello said.

Doctors performed the operation, but they were unlikely to have removed all the tissue, he said.

"They don't know if they have it all out," Castello said. "I don't know what's going to happen to me."

Legal action

Across the country, lawsuits have been filed by people who say they became infected by the use of bad body parts. On Wednesday, Castello, who still has to undergo blood tests, filed a lawsuit in the Cook County Circuit Court against BTS. The lawsuit also named as defendants the company's founder, Michael Mastromarino, a former dentist; and Life Cell Corp., which distributed a product made from the tainted tissue.

"It was a major, major problem for him," said Howard Schaffner, his lawyer. "It had grown into the surrounding tissue."

Schaffner has another client who last week filed a lawsuit against BTS and companies distributing a spinal graft at Advocate Lutheran General Hospital in Park Ridge. Adeeb Yousif, 49, claims to have gotten hepatitis from the graft.

The lawyer said he may also soon have a third client with a similar complaint.

"This is absolutely incredible that this is going on," Schaffner said. "You'd think there would be safeguards in place that would have prevented this from occurring."

Another local case

A 58-year-old Naperville man received a bone graft with bone from BTS. The man, who asked that his name not be used, went in for a molar removal at Ronald Freeman's oral surgery practice in Downers Grove and came out with potentially damaging bone plugging a hole in his jaw.

The oral surgeon asked him whether he would like to pay $40 to fix the canyon in his jaw from the surgery.

"It was just a little packet of bone," he said. "They put it in and stitched it up."

He received an alarming letter in the mail afterward that alerted him to the possible danger he may have been in.

He immediately had a blood test done, but didn't receive the results until after two to three months of anxious waiting. The results were negative as to any disease or infection.

At the time, he was told that it was highly unlikely that anyone had been infected or harmed. When he heard about the Castello case, though, he grew wary.

Now he plans to go back for more tests.

"This is really unsettling," he said. "Now I have to question whether one blood test is enough."

The man said he does not hold the oral surgeon's office at all responsible.

"I'd go back to him in a minute," he said. "I don't think he had any inkling that he wasn't being given properly cared for materials."

Extent unknown

BTS sold about 25,000 tissue samples to processors and distributors, with the tissues going to all 50 states.

Edward Hospital in Naperville did not receive any of the tainted materials, Brian Davis, Edward vice president of marketing, said in February. Edward's transplants come exclusively from the Gift of Hope Organ and Tissue Donor Network in Elmhurst.

Last year, the Food and Drug Administration launched an investigation into the scam. It discovered that the tissue could have been implanted into patients between early 2004 and September 2005.

Because of screening techniques, most tissue from BTS was unlikely to be infected, the FDA reported.

All tissue still in inventory from the firms supplied by BTS has been recalled, the FDA said.

The FDA recommends that patients who may have been affected be tested for HIV-1 and 2, hepatitis B, hepatitis C and syphilis.

Criminal charges

Authorities say Biomedical Tissue Services secretly carved up hundreds of cadavers among them, that of the host of "Masterpiece Theatre," Alistair Cooke without the families of the deceased knowing about it. They then peddled the pieces on the lucrative body parts market.

Criminal cases are pending against funeral homes across the country, and in New York prosecutors have charged two BTS officials with various crimes. Employee Lee 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.

Mastromarino, 42, remains free on $1.5 million bail after pleading not guilty to body stealing, forgery, grand larceny and other counts. If convicted, he faces as much as 25 years in prison.]]>
Inside the grim trade in human flesh and bone http://www.yourlawyer.com/articles/title/inside-the-grim-trade-in-human-flesh-and-bone Sun, 02 Jul 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/inside-the-grim-trade-in-human-flesh-and-bone They came to the funeral home in expensive cars, carrying clean hospital scrubs and pushing big tool boxes on rollers. Then they went to work in a makeshift surgi cal suite inside, cutting up cadavers and removing tissue and bone for eventual sale in the body parts market.

"Two people would cut one on the left side and one on the right," said Lee Cruceta, one of the body cutters. "There was also a 'back table' guy, whose job was to open a sterile bag. We'd drop tissue in it; he'd label it and put it on ice."

The funeral home was the stately Funeraria Santa Cruz, a landmark in Newark's North Ward also known as Berardinelli Forest Hill Memorial. Until now, it has never been associated with the international stolen body parts scandal that broke in New York City last winter.

But the Fort Lee man at the center of that scandal also operated at Santz Cruz. At least some of the body parts removed from cadavers there were taken without families' consent, and the fu neral home owner is under investigation by the Brooklyn District Attorney's Office, according to law enforcement sources. The sources spoke on condition of anonymity because the case is ongoing.

Santa Cruz was more than a major source of body parts, say people who worked there. It was also a training ground for future corpse-cutters.

Tissue harvesting is big business in the United States and perfectly legal, but it can also be a criminal enterprise.

As the Brooklyn District At torney says it was for Michael Mastromarino, a 42-year-old former dentist from Fort Lee indicted in February for allegedly stealing tissue and bones from 1,076 corpses in three states. The indictment made no mention of Santa Cruz at 253 Mount Prospect Ave. But Cruceta, a cutter who was charged with taking part in Mastromarino's alleged criminal enterprise, said in a recent interview with The Star-Ledger that crews worked on about 100 cadavers in a rear basement room there between February 2004 and September 2005.

Cruceta's matter-of-fact description of their work provides a rare glimpse into a dimly lit world, where unseen and anonymous workers rush in after a death to capture tissue while it is still fresh. The tissue is then sold to companies that process it for implantation in living patients. The bone-cutter's story also provides the first detailed view of how tissue-harvesting crews worked in New Jersey.

Although Cruceta and his crew used a mallet, saws and special bone-dividing tool called a osteotome, they worked quietly and did not disturb visitors who might be on hand for a funeral upstairs, he said.

"When you get down to cer tain parts of the body, it gets a little noisy," Cruceta said. "But that's a couple of minutes of noise."

The job took no more than an hour-and-a-half per cadaver, he said 45 minutes to "harvest" bones, tendons, skins, hearts or vessels, 45 minutes to close up the body.

'NOTHING SEEMED OUT OF PLACE'
Cruceta, 33, a licensed practical nurse from Monroe, N.Y., and father of four, has pleaded not guilty to the charges against him. During the interview, he said he did not believe he was doing anything wrong at Santa Cruz or other fu neral homes where he worked.

Mastromarino assured him the funeral home owners had obtained the families' consent, he said.

"Nothing seemed out of place," Cruceta said.

Stephen Finley, owner of Santa Cruz, has not been charged in connection to Mastromarino's operation. He declined to respond to repeated messages left by phone, mail and in person.

The 43-year-old resident of Mur ray Hill, a marathoner well known in running circles, bought the Newark funeral home from Carmine Be rardinelli in November 2000, property records show. From 2003 to 2005, Finley held a contract with the city of Newark to bury indi gents and unclaimed bodies; he currently holds a similar contract with Essex County through 2007.

Edgar Rivera of Newark, a former Santa Cruz employee, confirmed that Mastromarino and his crews were regular visitors to Santa Cruz in 2004 and 2005. Rivera lived in an apartment upstairs at the time; one of his responsibilities was to greet visitors; another was to pick up the bodies of the newly dead.

"Finley'd say, 'The guys are coming in today to do tissue dona tion.' I'd open the door," Rivera said. "They worked in the embalm ing room. Dr. Mike (Mastromarino) remodeled it, with new ceramic tiles on the wall. They put in one of them surgical lamps."

Rivera said he was fired from the funeral home in August 2005, just after the renovation. Finley had questioned Rivera's commit ment to the job and they argued repeatedly, he said.

The Brooklyn DA's indictment has triggered separate criminal investigations in Philadelphia and in Rochester, N.Y., where Mastroma rino's firm, Biomedical Tissue Services, worked at funeral homes. But several county, state and federal authorities in New Jersey said they are not investigating Mastroma rino, even though his crew worked at a number of funeral homes in north Jersey.

ASSESSING THE CADAVERS

Tissue donation is a booming, if loosely regulated, U.S. industry. One body can yield products worth thousands of dollars, for use in everything from spinal surgery to dental implants and collagen for plump lips. When done by the rules, tissue donation provides hope and relief to thousands of patients. Donated tissue is also used in medical research.

Authorities allege Mastroma rino did more than steal body parts. He also suppressed information about the true medical condi tions of some cadavers, passing off unsuitable tissue to tissue banks, they say. The FDA ordered his firm, BTS, to stop manufacturing in February. Mastromarino started the company after losing his dental license because of drug abuse, according to state records.

Since Mastromarino was indicted, many patients who had his tissue surgically implanted have filed suit. Mastromarino, his company, the tissue banks he supplied, and individual hospitals have been named as defendants.

Mastromarino, meanwhile, has pleaded not guilty to criminal charges. He declined a request for an interview.

Cruceta sat for an hour-long interview last week at the Manhattan office of his attorney, George Vomvolakis. The Brooklyn DA's indictment accuses him of falsifying family consent forms.

During the interview Cruceta said Mastromarino forged his name on "close to 500" consent forms and other documents, a charge denied Friday by Mastromarino's at torney, Mario Gallucci

Cruceta admitted signing oth ers, but said he misunderstood the purpose of the signature. He did not mean to signify that he had personally obtained consent from a relative, he said.

Cruceta said Mastromarino's New Jersey business started slowly, but grew nicely. He said most of the funeral homes involved were lo cated in "lower-income" areas, like the neighborhood served by Santa Cruz.

In Newark, business grew to the point funeral home owner Finley cleaned out a corner of his basement to create a storage area for crew members, Cruceta said.

About 80 percent of the cadavers he worked on at Santa Cruz were destined for cremation, rather than burial, he said. They yielded more bones and tissue than bodies that would be viewed and buried.

"If it was a cremation, we would recover (more) tissue," he said. "Otherwise, we just recovered from the lower (body)," he said.

Younger donors also yielded more. "With donors under 65 we would keep the whole knee capsule intact, for the tendons in the knee," Cruceta said. "With those over 65, we would separate the femur from the tibia."

Cruceta said it was his job to make physical assessments of bodies. They were usually lying on top of the table in the embalming room when he reported to work, he said.

At Santa Cruz he recalled one "Asian male (on whom) I found a lesion I thought was syphilis, so I ruled that case out," he said.

THE REASSEMBLY PROCESS

After cutting, crews reconstructed the body. Body-cutters routinely insert PVC pipes in place of the bones, to restore form to the body being prepared for viewing. At Santa Cruz, though, they often used wood, as "(plastic) gives off fumes and it damages the crema tion ovens," he said.

Cruceta said he worked at Santa Cruz, at various times, with cutter Christopher Aldorasi of Staten Island, who was also indicted and has pleaded not guilty; Darlene Deats and Kevin Vickers of Honeoye, N.Y., near Rochester, who trained in Newark and later worked for Mastromarino in Rochester; Kirssy Knapp of New York City, who worked for Mastromarino when he was a dentist and was his girlfriend, according to court papers, and later headed Mastromari no's Rochester operation; and occasional per-diem workers. Law enforcement sources confirmed the names.

All the cutters, as well as Mas tromarino, were certified as "tissue recovery specialists" by the American Association of Tissue Banks, an industry group that administers the certification examination.

Cruceta said he got into the business after his wife lost her job and he needed a second source of income.

"I was very impressed with Mas tromarino. He is a very smart man," he said. "I thought it was a very good career move."

Cruceta said he did not know of any financial arrangement between Mastromarino and Santa Cruz. But at other funeral homes, Mastroma rino paid funeral directors $1,000 per body, he said.

"I know because Michael asked me once to write a check to two di rectors" in Philadelphia, he said.

Funeral directors are rarely key players in cases involving tissue do nation, said William Reitsma, direc tor of clinical services for the non-profit New Jersey Organ and Tis sue Sharing Network in Springfield.

"Our donors typically come from hospitals," he said. "State law says every death in a hospital must be referred to us."

Program staffers determine if the cadavers are medically suitable for donation. If so, they approach families for consent.

"Usually we speak to the family before they've chosen the funeral home. If the answer is yes, we'll call the funeral home to say, 'This family is coming for funeral services and they've consented for dona tion.'"

Reitsma said bone and other tissue are removed in "operating rooms."

"These are sterile environments; these are not funeral homes," he said. From there the body goes to the funeral home.

Reitsma said his network pays funeral home directors "around $150 to $200" to handle bodies whose bone and tissue have been removed.

"Extra time is needed. When we take tissue, we disrupt the circula tory system. It takes longer to em balm," he said.

Berardinelli Forest Hill Memorial, renamed Santa Cruz after its sale to Finley in 2000, has long been an established institution in Newark.

In 1977, then known as Berardi nelli Funeral Home, it was engulfed by scandal when the New Jersey Board of Mortuary Science charged then-owner Carmine Berardinelli with burying 1,531 infants in mass graves rather than individual cas kets, according to state records. The complaint against Berardinelli said he had buried as many as 40 infants in one casket.

His license was ultimately suspended for six months.

]]>
Scandal rocks human tissue industry http://www.yourlawyer.com/articles/title/scandal-rocks-human-tissue-industry Sun, 02 Jul 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/scandal-rocks-human-tissue-industry
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.

From dentist to suspect

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 occu-pational 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.

Body parts harvested

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."

Funeral home visit

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.

"Cheap horror movie"

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.]]>
Tissue recall took months http://www.yourlawyer.com/articles/title/tissue-recall-took-months Wed, 28 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/tissue-recall-took-months
Meanwhile, federal and New York state public health officials took no discernible action to halt the flow of suspect body parts destined for surgical implantation.

Only after one of the company's business partners detected and reported a problem to health officials in September — about 11 months after the criminal investigation began did federal officials step in to challenge Biomedical Tissue Service's practices and order it closed. Ultimately, officials oversaw the largest-ever recall of human tissue, and recommended that thousands of people implanted with tissue gathered by Biomedical be tested for communicable diseases.

Biomedical now is accused by the Kings County (Brooklyn) District Attorney's Office of forging documents to gain access to cadavers and failing to ensure the tissue they harvested was free of communicable disease. Four company officials were indicted in February on 122 counts.

During that 11-month interval, Biomedical continued to recover tissue from human cadavers in the Rochester area, New York City and other locales, and continued to sell tissue for use in medical procedures.

In at least some cases, prosecutors say, tissue was gathered without proper consent from donors or their families.

Hundreds, if not thousands, of surgery patients during that time were implanted with tissue that came from the New Jersey company. In the Rochester area, most of the 60 patients known to have received Biomedical specimens had their implants after the criminal probe began.

Today, some of those patients are asking why authorities didn't act sooner to stop Biomedical.

"It could have been prevented if they'd notified the medical profession sooner. Now I blame the police for that," said Allis Sue Jones, an Albion, Orleans County, woman who received a Biomedical implant in June 2005, seven months after the New York Police Department and the Brooklyn district attorney began investigating the company.

Who knew what, when and whether any of the agencies involved could have shut down Biomedical sooner remain pressing questions, not only in the context of this case but also in other cases where criminal investigations and regulatory oversight converge.

"We simply cannot have a situation where the left hand doesn't know what the right hand is doing, and that's what happened here when an investigation is under way but the right folks aren't notified," said Sen. Charles Schumer, D-N.Y., who has introduced legislation to tighten federal oversight of tissue banks.

Neither the U.S. Food and Drug Administration nor the Kings County (Brooklyn) District Attorney's Office would discuss the chronology of their involvement in any detail. The state Department of Health, which licensed Biomedical, says it was notified of the criminal investigation in May 2005, about six months before Biomedical was closed. But its officials say they did not learn of the public health implications until after the tissue recall had begun in October.

Like thousands of other patients who received implants of bone, tendons, skin and other tissue from Biomedical, Jones has had to be tested to be sure she contracted no infections.

To date, her tests have been negative, though more than a dozen other recipients nationwide claim to have tested positive for hepatitis, syphilis or the virus that causes AIDS.

Suspect tissue not halted

Biomedical Tissue, which went into business in 2002, first came under suspicion by police in mid-November 2004, according to the Kings County District Attorney's Office. The investigation began when a man who had purchased a Brooklyn funeral home went to police with concerns about operations there, according to prosecutors. A police investigator went to the Daniel George and Son funeral home and learned that tissue was being recovered from bodies in a second-floor autopsy room by Biomedical.

How the police investigation unfolded from there is not clear; a spokesman for District Attorney Charles Hynes declined to provide details.

Whether the District Attorney's Office or the police informed the FDA of their probe also is not clear. An FDA spokeswoman, Julie Zawisza, declined to answer that question and many others, citing the FDA's own on-going investigation of Biomedical.

But on May 9, 2005, about six months into the probe, the New York state Health Department was first informed of the investigation by "appropriate law enforcement," according to department spokesman Robert Kenny.

Kenny would not say what the agency was told by the unnamed agency, or what, if anything, it did in response. "We have no comment, other than to say that when we're made aware of a criminal investigation, we certainly cooperate with the appropriate authorities," he said.

Within another month or so, in June 2005, Biomedical and the Daniel George funeral home learned they were under investigation, according to Mario Gallucci, a Staten Island lawyer representing Biomedical's owner, Dr. Michael Mastromarino.

"That's when all the original subpoenas went out," Gallucci said.

Despite that formal notification that Biomedical was a target of the investigation, neither law enforcement authorities nor health officials took any apparent action to halt shipment of tissue from the New Jersey firm.

Harvesting continued here

Still unclear is how many people nationwide received implants of Biomedical tissue while the investigation was ongoing.

Locally, at least 60 people received implants of tissue originating with the company. And about 85 percent of those patients underwent their surgeries after the investigation had begun, according to data supplied by area hospitals.

Similarly, Biomedical continued harvesting of tissue from human remains at funeral homes, including in the Rochester area, during the investigation.

In fact, all of Biomedical's tissue collection in Rochester likely occurred after the probe began.

Biomedical's only branch office, in an office building off Brighton-Henrietta Town Line Road, opened in November 2004, the same month the investigation began. Tissue recovery work at Rochester-area funeral homes did not begin until a few months later, said Kevin Vickers, a former Biomedical recovery specialist who lives in Honeoye, Ontario County.

As many as 65 cadavers were harvested for bone and other tissue in local funeral homes, and in at least some of those cases, decedents' families say they never gave consent for the donation.

Members of eight local families have joined lawsuits filed in Rochester courts asserting that their loved ones' bodies were desecrated after Biomedical recovered tissue without permission. The harvesting in those six cases took place between February and August 2005, after the criminal probe began.

Van Henri White, the Rochester lawyer who brought the lawsuit, said he has deliberated whether to name law enforcement or health agencies as defendants in the suit because of their failure to warn the public sooner about Biomedical's practices.

But he has dismissed the idea because the evidence is insufficient to support such a charge. He said that could change as more background on the investigation emerges in the pre-trial stages of his lawsuit.

White, a former prosecutor in Monroe County, said he assumed Brooklyn law enforcement officials didn't notify the public sooner because they thought a thorough investigation was needed to make sure any illegal conduct was stopped for good.

In terms of his clients people who say their loved ones' bodies were harvested for tissue without consent — White also wondered whether law enforcement was willing to let that activity continue because the victims were already dead.

"They might have thought and I'm speculating that this was a victimless crime," he said. "But that doesn't explain how they allowed these tissues to go into the bodies of other people. I really don't know how to explain comprehensively why they allowed this to go forward."

Industry spurs FDA recall

The public record does not show any action taken by the FDA or the state Health Department in the spring or summer of 2005. In fact, apparently nobody did anything to halt the flow of Biomedical tissue until September.

In that month, several of the companies that acquired tissue from Biomedical received subpoenas from a Brooklyn grand jury, according to public statements by those companies.

Toward the end of September, Dr. Michael Bauer, a Colorado physician working for one of those companies, LifeCell Corp., detected some inaccuracies with medical-screening information supplied by Biomedical and reported them to LifeCell. In turn, LifeCell notified the FDA of its concerns and began a voluntary recall of all tissue from Biomedical on Sept. 29, according to FDA reports.

According to the FDA's recall notice and statements by Mastromarino's lawyer, Mastromarino himself called in the FDA on Oct. 3.

"He contacted them and said, 'I have a problem with some of my tissue.' He put in effect the recall and had (FDA inspectors) come out," said the lawyer. The FDA began an inspection of the company the following day.

None of this became public until Oct. 7, when the New York Daily News published a lengthy story on the criminal investigation into Biomedical. Later that day, LifeCell issued a news release and stated that the company had begun its recall "when internal quality processes raised questions about the donor documentation" from Biomedical.

The FDA issued its first public statement on the case on Oct. 26, more than 11 months after investigators first began looking into the company. The agency noted there was no assurance that Biomedical had tested tissue properly, and it recommended that tissue recipients undergo medical testing.

Though she would not say when the FDA learned of the accusations against Biomedical, FDA spokeswoman Zawisza said the agency would have approached the matter deliberately.

"It takes time to collect and analyze all of the information and talk with the appropriate people and, finally, to determine the appropriate course of action," Zawisza said. "Throughout this process, (the) FDA continually considers the impact on public health and patient safety and the need for public notification, and strives to balance such concerns with the need to preserve the confidentiality of the investigation."

State health officials declined to say how they reacted when they learned of the Biomedical probe in May 2005. But they said they had no information at that time that the public was at risk.

Kenny said they did not realize that Biomedical was shipping tissue without ensuring it was safe until October, when the formal recall began.

"When it came to our attention that there could be an issue impacting public health, we didn't wait for the criminal investigation to be completed," he said. After gathering information about the recall, state health officials sent their own letter to New York physicians in December. They also began an independent assessment of the recall in March, amid complaints that the recall had progressed slowly.

Kenny said he had no information indicating that the Health Department should have been informed sooner of the facts behind the case.

Officials at the Kings County District Attorney's Office also declined to discuss any contacts the office had with health regulators.

Asked if the agency ever asked regulators to back off in deference to the criminal investigation, Jerry Schmetterer, the district attorney's information director, said: "We would never do anything to put anybody's health or life in jeopardy."
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Charles City Man Sues Over Implanted Human Tissue http://www.yourlawyer.com/articles/title/charles-city-man-sues-over-implanted-human-tissue Wed, 21 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/charles-city-man-sues-over-implanted-human-tissue
Keith Bruns filed a federal lawsuit in Cedar Rapids against several companies, including the tissue harvester, the company that distributed the tissue and two New York funeral homes.

Last fall, the Food and Drug Administration which had been investigating Biomedical Tissue Services of New Jersey ordered a recall of the company's products. The FDA warned that an untold number of patients could have been exposed to HIV and other diseases. The agency closed BTS in February.

Bruns' attorney, said tests show Bruns hasn't contract any disease linked to the bone and tissue, but he will have to have future tests.
Click here to find out more!

Federal lawsuits have been filed across the country, most seeking class-action status for hundreds of people who were implanted with tissues that the government recalled.]]>
Patients given stolen body parts http://www.yourlawyer.com/articles/title/patients-given-stolen-body-parts Wed, 21 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/patients-given-stolen-body-parts
Australia's medical watchdog, the Therapeutic Goods Administration (TGA) was last night trying urgently to contact 46 patients through their doctors to warn them of the developments.

The move came after evidence was presented to the watchdog that the material made from stolen human body parts had arrived in Australia.

The agency's own inquiries had previously failed to uncover the truth about the importation.

Among the people whose body tissue was illegally taken from funeral homes in the US was legendary BBC broadcaster Alistair Cooke, who died in 2004.

The bone, ligament and skin material much of it aged and, due to the potential for infection, unsuitable for transplant was traded to legitimate firms, which transformed it into products used to treat back pain, incontinence and other conditions.

The material implanted in Australian patients was brought in under a scheme that allows patients, in consultation with their doctors or dentists, to obtain products not yet approved for use here.

The TGA did not know if all the Australian doctors and dentists had gone ahead with treatments using the US-made product AlloDerm  used as an agent in plastic and reconstructive surgery. The TGA said it would be up to individual doctors to decide if their patients needed blood tests to detect possible infections.

This contradicts US Food and Drug Administration recommendations that anyone who received the stolen tissue be tested for HIV, hepatitis C and syphilis.

The US watchdog determined that, in some instances, blood samples designed to ensure the tissue was disease-free had come from the wrong people.

In the US, recycling dead humans has become a billion-dollar business, according to documents submitted to regulatory authorities.

Hundreds of products derived from dead humans are now available. Gels made from human skin are injected to smooth wrinkles, puff up lips or even fatten penises.

An ounce of bone putty, used in spinal surgery, can sell for more than an ounce of gold. Skin, tendons, heart valves and veins and corneas are listed for sale at thousands of dollars.

AlloDerm is manufactured by LifeCell Corporation of Branchburg, New Jersey, one of five companies that innocently received the stolen parts.

LifeCell, co-founded by an Australian researcher Stephen Livesey, has strong links to the taxpayer-funded Australian Stem Cell Centre in Melbourne, which innocently received at least three lots of product manufactured from the stolen tissue.

Dr Livesey is the centre's chief scientific officer. He also maintains links to his former company, LifeCell. He said the material sent to his centre was for research purposes only and it had not been used on patients.

"We have a licence agreement with LifeCell to use the material for research purposes and the material that was sent to us was specifically for that, for research purposes," he said.

"None of that material was for clinical use, and none of that material was implanted into people," Dr Livesey said.

When the stolen body parts scandal first broke in the US, the Australian watchdog said it had begun an investigation "immediately on receipt of US advice in October 2005" to see if any of the material had been imported.

In March, the agency stated it had conducted a thorough, nationwide check and found that none of the products had been imported into Australia.

But the TGA now admits that advice to the public was wrong. TGA experts had looked at the wrong company and had failed to even check the FDA website, which lists product lots sent to the US, Korea and Australia.

The TGA said yesterday that it had begun another, urgent investigation and had started contacting doctors.

AlloDerm is one of the LifeCell products recalled in the US. Dr Livesey said AlloDerm was never commercially distributed in Australia despite a LifeCell press release, dated August 15, 2000, that indicated that the product was to be distributed here.

He said the media release merely announced to the US stockmarket a distribution agreement with another US company.

The alleged desecration of bodies from funeral homes in Brooklyn, Rochester, New Jersey and Philadelphia is part of a continuing New York Police Department investigation that has scandalised America.

The police claim a former dentist and three associates secretly removed bones, skin, tendons and veins from corpses bound for cremation or burial. They then sold them through a US company called Biomedical Tissue Services.

In some cases, the bones were replaced with plastic pipes before the bodies were stitched up and returned to their families.

LifeCell and four other companies caught up in the scandal have stated that is unlikely that anyone who received the material was infected because of safety measures taken during the processing of the human tissue.

But lawyers representing victims in the US disagree.

"Potentially we know that AIDS and hepatitis can be transmitted. People must get a blood test," said, a lawyer representing some of the victims.]]>
Demand for body tissue has industry scrambling http://www.yourlawyer.com/articles/title/demand-for-body-tissue-has-industry-scrambling Sat, 17 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/demand-for-body-tissue-has-industry-scrambling
Ghoulish as the work sounds, it has become an indispensable part of modern medicine.

Corneas, tendons and bones from cadavers are routinely used to repair torn ligaments, bad backs, burned skin and a host of other ailments. The demand is so high that suppliers are hard-pressed to meet it.

"There is a huge shortage of donated tissue, especially for those us of us who demand high-quality tissue," says Dr. Kevin Stone, a San Francisco sports medicine surgeon.

The tissue recovery business goes largely unnoticed until a shocking scandal shakes the industry every few years.

Two years ago, the UCLA director of willed body parts was arrested on suspicion of illegally selling donated tissue. He was never charged, but UCLA shut down its program and the entire industry came under scrutiny.

More recently, a New Jersey company was accused of taking body parts without families' consent and, again, a scandal hangs over the industry.

TBI represents the industry's lawful side. This nonprofit tissue processor located in a nondescript office park 15 miles north of the Golden Gate Bridge makes about 300 products that surgeons use.

"This is the best technology going for a lot of surgeons," says James Forsell, who runs TBI's processing center.

Forsell has been working in the donated body parts industry for 20 years. As president of the American Association of Tissue Banks, he points out that the New Jersey company was not accredited by the organization.

"This is the worst thing that could have happened," a teary-eyed Forsell says.

Many of TBI's workers are foreign physicians awaiting their California medical licenses. The bank was launched by San Francisco's California Pacific Medical Center in 1986 and processes about 600 cadavers a year. It takes in about $20 million in revenue from the 300 different products it produces.

Body parts donated to TBI must be removed from a refrigerated corpse within 24 hours of death -- 12 hours if not refrigerated.

They arrive at TBI in blue packaging about the size of a pillow, packed in dry ice in plastic foam coolers.

Technicians in hospital gowns, goggles and masks working in sterile rooms began ridding the tissue of all living matter.

Marrow is blown from the bone with a high-pressure water spray and fat cut from muscle with scalpels, scissors and other instruments. The goal is to turn the tissue into inorganic material that can be stored on hospital shelves until needed.

"It's labor intensive," Forsell says of this first step. "It's pretty meticulous work."

Some tissue, such as spinal bone, is then carved and shaped by an industrial-sized table saw programmed by computer to cut specific shapes popular in back operations.

After the tissue and bone is devoid of living material and cut to the desired shapes and sizes, it is freeze-dried and bottled and shipped to another company to be irradiated.

Most banks briefly zap the tissue with radiation to kill any lingering viruses. Others use a chemical bath, a process preferred by some doctors because they believe it does less damage to the tissue, says Stone, who served as a doctor for the U.S. ski team.

He says his confidence in the sterilization of donated tissue has increased dramatically over the past five years. About 25 percent of operations on the anterior cruciate ligament of the knee now use donated tissue, he says, and the preferred material comes from healthy, young donors.

Before the technicians can begin operating on a cadaver, TBI administrators review the donor's medical and social history.

People are disqualified if they were recently released from prison or led a high-risk lifestyle.

The operating team also gives the cadaver a physical exam, looking for piercings, prior injuries and any other signs that the donor is less than optimal for processing.

The blood is immediately shipped out to be tested for HIV, hepatitis and other infectious diseases. The medical charts are checked to ensure a clean history and often the attending physician is consulted.

Once TBI begins processing the tissue, the same paperwork goes to the company's medical director, who reviews it yet again. It seems redundant, but it is necessary to ensure that patients are getting safe tissue, Forsell says.

"The real safety," he says, "is in the monotonous details of going through the charts and the paperwork."
Click here to find out more!]]>
New lawsuit filed in human tissue scandal http://www.yourlawyer.com/articles/title/new-lawsuit-filed-in-human-tissue-scandal Fri, 16 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/new-lawsuit-filed-in-human-tissue-scandal
The lawsuit, filed in state Supreme Court on Wednesday, is the third legal action brought in local courts against Biomedical Tissue Services.

The company, beset by criminal charges and civil actions, is accused of harvesting bones, skin and other tissue from cadavers without obtaining permission from the decedents' survivors and without ensuring the tissue was free of communicable disease.

Federal officials have said that Biomedical harvested and sold about 25,000 pieces of tissue for use in surgical procedures. The Fort Lee, N.J., company, which had a branch office in Brighton, ceased operations in October after the allegations were made public.

In the latest civil action here, the four adult children of Nancy E. Chamberlain are accusing Biomedical and the Burger Funeral Home in Hilton of recovering tissue from Chamberlain's remains without consent. Chamberlain, a Hilton resident, was 71 years old when she died in August.

The court papers say family members were never told by funeral directors Thomas E. Burger and Jason L. Gano that their mother's remains were to be harvested.

Chamberlain's body was cremated following the recovery procedure, according to the court papers.

The family was informed earlier this year by an investigator from the Kings County District Attorney's Office in Brooklyn that their mother's body had been harvested for Biomedical and that an unknown party had signed a consent form.

"They're extremely upset by it. I think it was more shocking than anything else," said the family's lawyer, Charles Schiano Jr.

The Brooklyn DA's Office, which has been investigating Biomedical since November 2004, brought an indictment against four men, including company founder Dr. Michael Mastromarino, in February. They are awaiting trial on charges including enterprise corruption, forgery, grand larceny, body stealing and unlawful dissection.

Biomedical did its initial tissue procurement work in a Brooklyn funeral home, but it opened the branch office in Brighton in late 2004 and forged relationships with as many as eight local funeral homes. Authorities have said the company recovered tissue from as many as 65 bodies locally.

A local lawyer representing Burger Funeral Home, Charles Zambito, said Thursday that he had not seen a copy of the latest lawsuit and could not comment on it.

Two other suits alleging unauthorized tissue harvesting, filed on behalf of the families of seven deceased people, are pending in Rochester courts.

Dozens of lawsuits have been filed nationwide against Biomedical by people whose loved ones' bodies were harvested by Biomedical, and by surgery patients who received tissue implants that originated with Biomedical.

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Researcher Mum in Human Tissue Hearing http://www.yourlawyer.com/articles/title/researcher-mum-in-human-tissue-hearing Wed, 14 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/researcher-mum-in-human-tissue-hearing
A senior government researcher asserted his Fifth Amendment rights Wednesday and refused to testify before Congress about allegations that he profited from sharing human tissue samples with a drug company.

"I respectfully decline to answer this question and any other questions based on my constitutional rights,'' Alzheimer's disease expert Dr. Trey Sunderland said in response to the first question from members of a House subcommittee.

At the same hearing, the director of the National Institute of Mental Health told lawmakers he had recommended that Sunderland be fired.

Investigators with the House Energy and Commerce Committee say Sunderland shared thousands of human tissue samples with drug maker Pfizer Inc. and appears to have netted at least $285,000 from work associated with that transfer.

Lawmakers complained to the National Institutes of Health about its monitoring of tissue samples, which are increasingly used to make medical discoveries that improve patient care. NIH officials said they were planning steps to better account for where and how the samples are being used.

"Federal laws and policies do not permit NIH scientists to profit personally from their jobs and their patients by providing irreplaceable government assets,'' said Rep. Ed Whitfield, R-Ky, chairman of Energy and Commerce's oversight and investigation subcommittee.

On the hearing's second day, Sunderland was sworn in and then cited his right to avoid risking self-incrimination. A former colleague of his, Karen Putnam, did the same.

In a brief interview following the hearing, Sunderland said he submitted his resignation on Nov. 8, 2004, and has waited to leave since then.

"I really want to get through this and move on,'' Sunderland said. His attorney, added: "NIH has held him captive.''

Muse previously has said the scientist, who is chief of the geriatric psychiatry branch at the National Institute of Mental Health, followed NIH rules and took no money for providing the samples.

The director of the mental health institute, Dr. Thomas Insel, said he would have fired Sunderland but he did not have the authority because the scientist, though tasked to the institute, was employed by the public health Commissioned Corps.

Insel said he had recommended to the Commissioned Corps in November 2005 that Sunderland be terminated.

Earlier, an NIH spokesman, John Burklow, said the "specific consulting arrangements in question, had they been known to NIH, would not have been approved'' under ethics regulations. He said collaborations among scientists that involve human tissue samples are common and essential, but there are rules to protect the samples and to ensure there is consent about the use of the samples.

Sunderland's outside work has prompted scrutiny from committee investigators before. About two years ago, the committee said Sunderland had received $517,000 since 1999 in consulting fees or expense reimbursements from Pfizer and that there was no record that he received prior approval for those activities or disclosed it in his financial report filings.

The NIH reviewed the case and tightened its rules for outside work arrangements. It also referred an allegation to Health and Human Services' inspector general that Sunderland may have conducted outside activities during government work hours. There has been no resolution of that referral.

At the NIH, Insel said, it "is not good enough to be clean. It has to be Camelot. There can be no question of conflict of interest.''

In the meantime, congressional investigators continued to probe Sunderland's work with Pfizer on an Alzheimer's drug. They concluded there were "reasonable grounds'' to believe $285,000 of the $517,000 he received from Pfizer was for work derived from giving the drug company access to spinal fluid samples and plasma samples.

Muse said his client "didn't receive a dime for providing anything to Pfizer. He received fees for consulting as well as for lectures. These were known to NIH and they were permitted under NIH rules.''

The transfer of spinal fluid samples was done under a 1998 material transfer agreement, or MTA, between the National Institute of Mental Health and Pfizer.

"We sought a partner who had knowledge, experience and access to samples that would make this project possible,'' former Pfizer employee David Friedman testified of the work on pinpointing proteins in the samples that could signal the advent of Alzheimer's. He added that payments to Sunderland were not in exchange for the samples.
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Jury to get body parts probe http://www.yourlawyer.com/articles/title/jury-to-get-body-parts-probe Tue, 13 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/jury-to-get-body-parts-probe
The grand jury's role has come to light just a couple of days after state officials negotiated with Louis Garzone and his younger brother, Gerald Garzone, also an undertaker, to voluntarily relinquish their funeral directors' and parlors' licenses.

"I am pleased that journalism worked," said Kevin Vickers, a former tissue-company worker who first told the Daily News in a February interview that he cut up dozens of corpses inside the Louis Garzone Funeral Home.

Vickers worked for the now-defunct Biomedical Tissue Services Ltd. (BTS), based in Fort Lee, N.J., which sold tainted body parts obtained from up to 30 funeral homes in New York, New Jersey and Philadelphia.

Vickers said that he drove to Louis Garzone's funeral home several times - dissecting bodies and extracting veins, tissues and tendons - on behalf of BTS.

The failed company has become the center of a nationwide scandal involving tainted body parts. The tissue company would pay funeral directors across the tri-state area up to $1,000 per body, Vickers said.

BTS would later receive as much as $7,000 per body, according to investigators.

The U.S. Food and Drug Administration, which shut down BTS last February, warned that implant and transplant patients could have received tissue tainted with hepatitis, syphilis and HIV. Since then, the Centers for Disease Control found numerous victims who tested positive for those illnesses.

Until the Pennsylvania Department of State's announcement last week, only Louis Garzone was named in allegations.

But on May 12, Gerald Garzone signed a state agreement to surrender his licenses, documents showed.

Still, Gerald Garzone continued to conduct funerals until June 6, the day before the state Bureau of Professional and Occupational Affairs officially closed down his business.

William Henion, 82, said he paid Gerald Garzone $7,300 to conduct his wife's June 5 funeral. Henion said while he read the newspaper articles detailing the alleged tissue harvesting operation inside the Louis Garzone Funeral Home, he still trusted Gerald Garzone with his wife's body.

"I would still give him a recommendation," Henion said. "I am sorry for his wife and children."

Gerald Garzone, who lives in the same building as his funeral home, said he and his family have "been here our whole lives" and does not plan on leaving his Juniata Park neighborhood.

He declined to comment further.

The state charged that the Garzones allegedly acted with "gross incompetence, negligence and misconduct over an 18-month period from 2003 to September 2005."

However, the Garzones' attorneys negotiated a plea that allowed both funeral directors to admit no wrongdoing while surrendering their licenses.

Howard Kaufman, attorney for Louis Garzone, said his client "did what he thought he needed to do.

"I do not believe his business was declining," he added.

The brothers' jointly owned cremation business, Liberty Cremation Inc., remains in good standing with the Department of State, the agency which nullified the Garzones' licenses.

"The Department of State does not license crematoriums and does not have the statutory authority to license [them]," said department spokesperson Leslie Amoros.

The state agency only licenses the funeral homes and directors in Pennsylvania.

Several local funeral homes have sent corpses to be cremated at Liberty Cremation, just across the street from the Louis Garzone Funeral Home on Somerset Street near Ruth.

Families have questioned whether body parts were taken from their loved ones whose remains were cremated at Liberty. Investigators are aware of the issue and have been seeking answers, according to sources close to the investigation.

Agnes Folger, 84, whose husband, Joseph, died in 2004, has repeatedly confronted Louis Garzone about her husband's cremation, and asked whether any body parts were removed without her permission.

Funeral director Edward Tomaszewski, who handled the funeral of Joseph Folger, said he would not use Liberty Cremation because of the body-parts scandal.

"I am not working with Mr. Garzone," he said. "It is a black eye to the industry."

Tomaszewski said he sent remains to Liberty because it was close to his funeral home on Allegheny Avenue near Frankford. But now he uses a West Philadelphia crematorium.

"It is better to sacrifice money and distance rather than your reputation," said Tomaszewski, whose family has operated the business since 1924.

Weeks after the FDA shut down BTS, the Brooklyn district attorney's office announced its indictment, saying the company failed to screen donors properly and to keep accurate records about the corpses it allegedly sliced up.

In March, the Daily News first reported that Louis Garzone was linked to the Brooklyn probe, prompting the separate investigations led by the Department of State and the Philadelphia D.A.'s office.

Cathie Abookire, spokeswoman for the Philadephia D.A., confirmed that the office was investigating but declined to say whether a grand jury was involved.

In addition to Vickers detailing his work at Louis Garzone, a second BTS worker, Lee Cruceta, told the Daily News he removed body parts at Garzone between March 2004 and September 2005.

His lawyer, George Vomvolakis, said his client, who was indicted in Brooklyn and under investigation here, will cooperate with authorities.

"He was just an employee with Biomedical," Vomvolakis said. "He was not aware of state law in Pennsylvania." It is against state law for funeral directors to authorize tissue removal.

"Everything else was left to Garzone" and BTS owner Michael Mastromarino, the lawyer said.

"Dr. Mastromarino sympathizes with the donor families and donor recipients," said Mario F. Gallucci, lawyer for BTS.

"He, too, believes he was victimized by these unscrupulous funeral directors, but he assures the public that all the tissue he harvested was tested by the processors and sterilized prior to its use."
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Tissue scandal touches family of BBC’s Cooke http://www.yourlawyer.com/articles/title/tissue-scandal-touches-family-of-bbcs-cooke Mon, 12 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/tissue-scandal-touches-family-of-bbcs-cooke
Three days later, Cooke returned home in a small, cardboard box.

Susan Cooke Kittredge examined the ashes of her father, the refined and legendary host of “Masterpiece Theatre” on PBS and longtime BBC correspondent.

Something was odd.

A minister, she had handled ashes in the past; usually there were shards of bone. Why were these smooth and fine, like talcum powder? What was a coil of wire doing in the ashes? She wondered whether it came from the knee replacement her father had had years before.

She told a few people what she found, but didn’t give it much thought.

“It never occurred to me for a minute,” she says, “that it might be a byproduct of someone having engaged in some nefarious endeavor.”

It never occurred to her that her father’s body had been plundered, its parts sold. It never occurred to her that her father would end his 95-year journey through life as a tabloid headline, embroiled in the worst scandal ever to hit the industry that deals in human tissue.

A rapid decline in health

From 1946 until shortly before his death, Cooke produced his “Letter from America,” a weekly, 13-minute show broadcast on the BBC in which he provided insights for Mother England into the character of the United States.

Cooke would type his letter in his apartment overlooking Central Park, often working in his bathrobe after a hearty breakfast – a smoky haze lingering from the previous night’s entertaining. In his long life, cigarettes were a constant.

In late 2003, he developed a nagging cough. As fall turned to winter, it became hard for him to leave his apartment.

On an unusually warm day in February 2004, he felt well enough to visit a doctor at Mount Sinai Medical Center. The news was bleak: lung cancer. It had spread to his bones; he didn’t have long to live.

Shortly before his death, Kittredge realized she had to make funeral arrangements. Her father wanted to be cremated (perhaps, she thinks, he felt it was “efficient and neat”) and so she turned to the phone book.

Thumbing through the pages, she found a good deal. The New York Mortuary Service in East Harlem agreed to do the job for about $600.

“I essentially chose the one that gave me the best price for a direct cremation,” she said.

Her father died days later. She touched his warm hand and removed his watch. When the body was gone, she concentrated on the man, not his lifeless shell.

“You want to remember the person in the fullness of their life,” Kittredge said.

And so it was that 2,000 people attended a memorial service at Westminster Abbey – a proper tribute to a man who received an honorary knighthood in 1973 and heard remarks by Mark Thompson, director-general of the BBC.

“He mistrusted dogma and blind faith wherever he found them, unless of course it involved the science of serving a perfect whiskey, or the beauty of Gabriella Sabatini’s forehand,” Thompson said. “He was genuinely taken aback when age and infirmity caught up with him in his 95th year. He had fully expected to die in harness.”

Unthinkable desecration

One Friday last December, Kittredge received a phone call from a New York City detective. Politely and respectfully, he asked whether she had heard about an investigation involving the illegal procurement and sale of body parts. She had not.

He asked whether her father was the Alistair Cooke. She said yes.

And then, he delivered the news: He had reason to suspect a New Jersey company had ransacked her father’s body.

She stopped listening. Her mind shut down. The conversation ended.

Over the weekend, she trolled the Internet looking for information about a crime that seemed like something from one of Dickens’ stories.

She called the detective on Monday. Could there be a mistake? Was there any chance that Daddy’s body had not been taken?

No. Police had the receipts for his bones, which were sold for thousands of dollars to Regeneration Technologies Inc. and Tutogen Medical Inc., companies that profit from processing cadaver tissue for use in living people.

The crooks slipped up, the detective said, leaving a paper trail. To transform him into a suitable donor and erase signs of his diseased tissue, they falsified his cause of death, listing it as a heart attack, not cancer, authorities say. The age was listed as 85, not 95.

Later, Kittredge learned the bones came from Cooke’s legs.

“To know that they chopped off his legs, then you can’t help but see in front of you a truncated person on the floor whose head comes up to the waist,” she said.

That’s when the nightmares began. Kittredge dreamed of opening a door and finding a screaming, legless father reaching out to her.

Her father was just the most famous victim of many, authorities say. They said a New Jersey company, Biomedical Tissue Services, lacked consent to take bones, tendons, ligaments, skin and other tissue from cadavers. The owner of BTS and three others have pleaded not guilty to the charges. The company has closed.

Kittredge was shocked by the possibility that some recipients of infected tissue might have become seriously ill.

And she wondered what happened to her father’s bones. Was someone using them? She was told no, that the bones were never implanted in anyone.

She’s not so sure. She doesn’t even know what happened to the rest of her father, his torso and arms. Did the remainder wind up in the trash?

And the ashes she scattered in Central Park. What were they?]]>
A look inside a tissue processing plant http://www.yourlawyer.com/articles/title/a-look-inside-a-tissue-processing-plant Mon, 12 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/a-look-inside-a-tissue-processing-plant
This nonprofit tissue processor, located in a nondescript office park near San Francisco, makes about 300 products surgeons use to fix torn knee ligaments, bad backs, burned skin and a host of other ailments.

"This is the best technology going for a lot of surgeons," said James Forsell, who runs TBI's processing center in San Rafael, a suburb about 15 miles north of the Golden Gate Bridge.

An increasing number of doctors are using tissue bank products, and TBI now processes some 600 cadavers a year, translating into about $20 million in annual revenue. But the entire industry has fallen under a cloud after a New Jersey company was accused of taking body parts without families' consent.

"This is the worst thing that could have happened," a teary-eyed Forsell said. He has been working in the donated body parts industry for 20 years and is president of the American Association of Tissue Banks.

He points out that the scandalized company, Biomedical Tissue Services, was not accredited by the organization, as most tissue banks are. The association has stringent consent requirements that include dozens of questions asked of family members who make donation decisions, Forsell said.

On a recent day, TBI workers wearing hospital gowns, goggles and masks in sterile rooms began ridding the tissue of its living matter.

Marrow is blown from the bone with high-pressure water spray and fat cut from muscle with scalpels, scissors and other instruments typically used in operating rooms. The goal is to turn the tissue into inorganic material that can be stored on hospital shelves until needed.

Once that first step is completed, some tissue such as spinal bone is carved and shaped by an industrial-sized table saw programmed by a computer to cut the material to specific shapes commonly used in back operations.

The tissue and bone is then freeze-dried, bottled and shipped to another company to be irradiated, which kills any lingering viruses. The radiation turns the clear bottles brown.

While all of this is happening, TBI administrators are reviewing the donor's medical history. Even before the team begins operating on a cadaver, family members are asked about the donor's medical and social history. A donor is disqualified, for instance, if he or she was recently released from prison or led a high-risk lifestyle.

And before any body parts arrive at TBI, the company's operating team gives the cadaver a physical examination usually in a morgue or hospital. These technicians are looking for piercings, previous injuries and any other signs that the body isn't right for processing.

The donor's blood is also immediately shipped out to be tested for HIV, hepatitis and other infectious diseases. The medical charts are checked to ensure a clean history and often the attending physician is consulted.

"The real safety is in the monotonous details of going through the charts and the paperwork," Forsell said.]]>
Interpol expose SA body brokers http://www.yourlawyer.com/articles/title/interpol-expose-sa-body-brokers Sun, 11 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/interpol-expose-sa-body-brokers
The Interpol probe into the country’s multimillion-rand tissue industry – which turns donated bones, skin and tendons into end products began this week. It was a request requested by US health watchdog, the Food and Drug Administration (FDA).

A forensic investigator, authorised under the Human Tissues Act by the Department of Health, visited the only two tissue banks in South Africa and removed copies of documents, including donor registers and export permits.

His appointment was confirmed in a letter which he handed to tissue-bank officials signed by the Director-General of Health, Thami Mseleku.

The letter authorised him to investigate “allegations of illegal exportation and/or harvesting and/or transportation of human tissue for the purpose of business”.

He was joined by a senior investigator from the police Commercial Branch.

The probe will also cover allegations of the illegal harvesting of tissue without donor consent.

The National Tissue Bank (NTB), based at the University of Pretoria, and the Centre for Tissue Engineering (CTE), at the Tshwane University of Technology, sell a range of products crafted from human tissue to orthopaedic, plastic, maxillofacial and neurosurgeons and dentists.

Department of Health spokesman Solly Mabotha told the Sunday Times that South Africa was faced with a “frightening threat of illegal trafficking of organs and tissue”.

FDA special agent Rande Matteson, declined to comment on the probe, saying only that it was part of of an “ongoing investigation”.

This follows close on the heels of a major US tissue scandal last year which saw unscreened, diseased tissue stolen from bodies in funeral homes, sold to leading tissue banks and transplanted into American patients.

Class-action law suits are now under way, filed by hundreds of recipients infected with HIV, syphillis and hepatitis.

Both the NTB and CTE export tissue overseas through US distributor Global Orthopaedics, based in Florida, which has ties to a US tissue bank involved in the contamination drama.

Records show the two banks sent shipments in the last five years to Turkey, Spain, El Salvador, South Korea, Namibia, Germany and Switzerland.

Both banks this week said all their exports were above board.

The export records reveal that the NTB, which does not procure heart valves, exported at least 120 valves to Germany. NTB said this week that its medical director, Dr Theo le Roux, had applied for export permits on behalf of Southern Cryoscience, a company which harvests and processes heart valves.

But the bank said on Friday that the practice would stop as it was uncomfortable with a private company dealing in human tissue.

An independent three-month Sunday Times investigation has established that:
  • The tissue banks pay people at government mortuaries, funeral homes and eye banks to help them find donors;
  • Funeral giant Doves this week pulled out of an arrangement with the CTE from which it had received payment for tip-offs about potential donors. In a memo to staff outlining strict new protocols, CEO Hannes Wilken banned staff from accepting money from tissue organisations or contacting families of the deceased regarding donations.
  • For five years the lid was kept tightly on an export scandal involving a top South African orthopaedic surgeon, who is also a former tissue-bank official. He was involved in shipping cartons of South African tendons to Florida businessman Philip Heitlinger via South Korea in 2001. It is illegal to import South African tissue into the US.
  • The relationship between the two tissue banks, which operate within a few kilometres of each other, is strained and because of this there is a battle over access to the SA’s small local donor base.
  • The NTB, which processed 125 donated bodies last year, claims the advent of the CTE opening in 2002 has had a dramatic effect on its donor base.
But the CTE denies this. It refused to disclose how many bodies it processed last year, saying only that it had retrieved enough material to treat 15000 patients.
  • The NTB has changed the arm that markets and distributes its donor products three times in the past four years; and
  • The marketing and distribution partner of NTB and the CTE, Bone SA, has for four years been involved in a legal wrangle over patent rights for donor tissue products.
Medical scientist Dr Nicolaas Duneas, acting head of CTE, said he welcomed the Interpol investigation as his bank had nothing to hide.

He admitted his bank paid money to Doves and was very concerned that the arrangement with this “supplier” had stopped. “They will not do any work if they do not get reimbursed for time and effort.”

The CTE had an export policy which it openly disclosed freely to “anybody that wants to ask”.

NTB business manager Willem Boshoff said an investigator had visited his bank this week and customs officials had visited a few months ago “related to an Interpol inquiry”.

“We have not done anything wrong,” he said, but admitted there needed to be “proper control” from the government.

“I think we maybe should be more transparent, but I don’t think we are misleading the public,” he said.
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Lax oversight increases odds of tainted tissue http://www.yourlawyer.com/articles/title/lax-oversight-increases-odds-of-tainted-tissue Sun, 11 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/lax-oversight-increases-odds-of-tainted-tissue
A million people a year have operations that use donated tissue from dead bodies. The nation's largest tissue bank had supplied this cartilage. It was disinfected and perfectly safe, he assured them.

But it wasn't.

Four days after this routine, elective surgery, Lykins a healthy 23-year-old student from Minnesota died of a raging infection.

He died because the cartilage came from a corpse that had been unrefrigerated for 19 hours a corpse that had been rejected by two other tissue banks.

The cartilage hadn't been adequately treated to kill bacteria.

None of this broke a single federal rule.

And it could happen again today it is likely still happening today because of shoddy practices by some in the billion-dollar body-parts business and the lack of government regulation.

The industry is in the news because a New Jersey company is accused of scavenging corpses without families' permission and selling those parts to tissue processors. But apart from this scandal, thousands more Americans each day are put at risk in more insidious ways by legitimate tissue suppliers.

A three-month investigation by The Associated Press found problems such as inadequate testing for potentially deadly germs and the lack of a unified system for tracking tissues from donor to recipient.

At every step from funeral homes to hospitals and doctors' offices, where patients receive the eyes, bones, skin and other parts of the dead poor oversight invites abuse and creates danger.

Most tissue transplants involve reputable companies and do a lot of good.

Olympic skiers, people who have lost eyesight and children born with bad hearts are among the millions who have benefited. But when things go wrong, the consequences can be horrific.

Ken Alesescu died May 14 in his home in San Luis Obispo, Calif., the victim of a fungus-infested heart valve.

Alan Minvielle, of Santa Cruz, Calif., lost a job and almost lost a leg to gangrene from a bad tendon.

Bonny Gonyer in Chippewa Falls, Wis., has pain and a limp because of tainted tissue.

"It angers me when I read these stories," Pam Alesescu, the heart-valve recipient's widow, said in an interview shortly before he died. "My kids are losing their dad, and I am losing my husband."

The federal agency responsible for tissue safety, the Food and Drug Administration, is well aware of the problems. Yet many experts believe the rules the FDA implemented last year as a long-promised overhaul fall short of providing the oversight needed.

Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses.

When it does inspect, public health isn't always protected. In 2003, an FDA inspector saw that Biomedical Tissue Services  the now-notorious New Jersey company wasn't documenting what it did with tissue unsuitable for transplant. The FDA let the matter drop after the company sent a letter saying it had fixed the problem. For two more years, thousands of people received tissue.

"I'm not surprised that a BTS occurred. And there will be others," said Areta Kupchyk, a former FDA lawyer who drafted rules that were ultimately adopted in watered-down form. "We continue to be at risk."

Here are some of the ways:

A trade group, the American Association of Tissue Banks, requires accredited members to follow high standards, but without the FDA doing the same, hospitals and doctors can buy from unaccredited suppliers that offer tissue quicker or cheaper.

Tissue isn't tested as thoroughly as blood is for infectious diseases.

The FDA sets no limits on the age or health of donors or how long after death tissue can be taken.

Funeral homes don't have to report deaths to organ-procurement groups, leaving them outside a regulatory system and able to cut side deals to supply body parts.

Doctors often know little about the origins of tissue. Some hospitals buy it like surgical gloves and other supplies based on price and availability. Patients are not always told that they are receiving tissue from a cadaver or offered alternative treatments.

Hospitals and doctors do not have to report tissue infections to health officials, and evidence suggests that many infections are missed.

The FDA requires no medical training to run a tissue bank or procure tissue.

And business is booming.

The number of tissues distributed for transplants rose from 350,000 in 1990 to 650,000 in 1999 and 1.3 million in 2003. Tissue companies are awash in cash, even the nonprofits. The biggest is the Musculoskeletal Transplant Foundation of New Jersey. In 2004, it had $243 million in revenue and paid its chief executive $542,212.

The FDA, on the other hand, lacks staff and money. It spends $5.4 million a year on tissue regulation less than two days' revenue for the industry. Inspections of tissue businesses peaked at 285 in 2004, but the number of companies rose from 1,325 two years ago to 2,030 now.

However, many gaps in oversight have nothing to do with resources and stem instead from an FDA and Bush administration philosophy of not wanting to burden industry.

The FDA rules often state broad goals and let industry decide how to meet them. They say tissue should be tested for germs but do not specify the type or level of testing. That's also true for how tissue is disinfected. Some tissue, in fact, is not disinfected at all.

Mary Malarkey, an FDA quality and compliance official, said that she believes tissue is safe and that she would have no qualms about receiving it. "I do actually have family members and friends who have," Malarkey said. "I take that very seriously."

The trade association's president, James Forsell, said that most big companies are association members and that consumers are protected by his group's accreditation process.

When Lykins and others got contaminated tissue a few years ago from a Georgia-based bank, CryoLife, that company was not accredited. Now it is, and company officials say they have several new testing and treatment procedures to prevent such problems.

If a nonmember like Biomedical Tissue Services wants to falsify records or ignore proper procedures, "there is precious little that can be done," Forsell said.

Even doctors don't understand the risk of tissue they are using. "It comes in a nice package. It looks sterile," said Dr. Matthew Kuehnert, a tissue-safety expert at the federal Centers for Disease Control and Prevention.

"Most physicians don't even know the questions to ask," said Dr. Ty Endean, a Tucson, Ariz., orthopedic surgeon. "They order tissue and they leave it up to the surgical center at their hospital. And those people are just going on price."

Often, the people who order tissue for operations don't know how it was treated or even all the companies that handled it. When the Biomedical Tissue Services scandal broke, some hospitals did not even realize that their tissue had come from an unaccredited supplier.

Kuehnert wants a uniform system to trace tissue instantly from donor through processors to recipients: "This is a daunting task, but it is doable."

It's doable if people want it, says Steve Lykins, the father of the Minnesota student who died.

"What the tissue companies did when Brian died was legal. The problem was, there were no laws out there to break," he said. "Any one of us could have opened a tissue bank in our garage. We could have hired the neighborhood kids who were interested in science to work for us."

Lykins and his wife, Leslie, have made many trips to Washington, lobbying for change.

"We didn't want to be sitting around watching TV and hear of another case where someone had lost a son like we lost Brian and know that we didn't do anything about it," he said. "We worked very hard for quite a while to encourage the FDA to start regulating this industry."]]>
Body-parts scandal like a grade-B horror flick http://www.yourlawyer.com/articles/title/body-parts-scandal-like-a-grade-b-horror-flick Sun, 11 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/body-parts-scandal-like-a-grade-b-horror-flick 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. It then peddled the pieces on the lucrative non-organ body parts market.

Even scarier: They say the company 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.

Accomplishment and rumors

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 were 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 possessing a hypodermic needle and Demerol, according to the documents. His lawyer, 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 Biomedical Tissue Services 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.

Turning to funeral homes

Femurs. Tendons. Heart valves. Swatches of skin from the thighs, abdomen 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: the company 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 the company's headquarters.

Internal company documents suggest the firm 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?"

It seems no questions were asked in hundreds of cases.

Family members have told investigators no one sought permission for donations. The signatures on 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 Biomedical Tissue Services.

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."
Detective: "I was shocked"

In November 2004, New York City Detective Patricia O'Brien responded to a complaint from a funeral director in Brooklyn. The director said 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 transplant.

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.
Like a "cheap horror movie"

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 plumbing pipe back into the bodies in time for open-casket wakes.

Lawsuits filed by implant patients accuse Biomedical Tissue Services of exposing plaintiffs to hepatitis and other infectious diseases. Families of the dead have sued, too.

The Food and Drug Administration shut down the company amid its own investigation this year. The agency said it had uncovered evidence the firm failed to screen for contaminated tissue. Parts were recovered from people who had diseases that 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 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. He refused requests for interviews by The Associated Press.

If convicted, he faces as much as 25 years in prison.

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Ask tough questions about donor tissue http://www.yourlawyer.com/articles/title/ask-tough-questions-about-donor-tissue Sun, 11 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/ask-tough-questions-about-donor-tissue
But sometimes those donated body parts can carry dangerous diseases.

HIV, hepatitis, rabies, deadly bacteria and fungus are among the infections that have stricken some who've had tissue transplants in the last 15 years.

And that was before the ghoulish scandal in which a New Jersey company is accused of selling bones and tissue illegally obtained from the bodies of people too old or sick to be donors, including Masterpiece Theatre host Alistair Cooke, who died of cancer at 95.

It's not known whether cancer can be passed on from donated tissue, but Cooke's body was in no condition to be a donor source.

With lax regulation of the donated tissue industry, patients need to protect themselves if they are planning an operation using tissue from a cadaver.

"My focus is to tell people one thing: This can happen to you," said Steve Lykins, whose 23-year-old son died five years ago after a knee operation using donor tissue.

Ask lots of questions:

• If you need surgery to fix bones or tissue, ask whether donor body parts will be used, and whether there are alternatives. Some operations can be done using patients' own bone or tissue, although that's more invasive. Artificial tissue or animal tissue may also be options.

• If human donor tissue will be used, "Look (your) doctor in the eye and say, 'Do you know that this came from a certified tissue bank and that you're comfortable with where it came from?" advises Dr. Stuart Youngner, a medical ethicist at Case Western Reserve University. Companies that are accredited by the American Association of Tissue Banks are required to follow that group's standards, including sophisticated testing for germs.

• Get the names of each company that retrieved, processed and distributed your tissue, and make sure each one is a member of the American Association of Tissue Banks.

• Have surgery done in an institution accredited by the Joint Commission on Accreditation of Healthcare Organizations. The commission has set detailed standards on tissue handling for hospitals and surgery centers it oversees.

Fungus: More than 500 heart valve transplants each year are thought to be contaminated with fungus, leading to an estimated 207 deaths a year.

Hepatitis C: Cases in 1992, 1995 and 2002. More than 40 people received contaminated organs or tissue after an Oregon tissue bank failed to detect the virus in a single donor in the 2002 outbreak. One died, probably as a result.

Hepatitis B: 1954. One tissue transplant.

HIV: 1983 and 1992. Four tissue transplants.

Clostridium, "flesh-eating," and other types of bacteria: November 2001. A Minnesota man's death led to discovery of more than 60 other bacteria-contaminated transplants in 20 states, including some tissues infected with multiple types of bacteria.

Cytomegalovirus, or CMV: Cases have occurred involving donated skin.West Nile virus: August 2002. Several organ recipients developed fever and altered mental status from virus-contaminated transplants.

Rabies: 2004. Three organ recipients and one tissue recipient died after contaminated transplants.

Chagas disease: April 2001. Three people caught this parasite, common in Latin America, from organ transplants from a common donor.

LCMV, a rodent virus: May 2005. Three people died after receiving contaminated organs. Others received tissue from the same donor. Three others died in December 2003 after receiving organs infected with LCMV.

Tuberculosis: 1953. One tissue transplant.
Spread through transplants

Many viruses, bacteria and other germs have spread to people through transplants of tissue from cadavers or organs from live donors.]]>
Inspections decline in tissue industry http://www.yourlawyer.com/articles/title/inspections-decline-in-tissue-industry Sun, 11 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/inspections-decline-in-tissue-industry
While demand for donor tissue is booming, government inspections have fallen. In 2001, the Food and Drug Administration inspected 1 in 3 registered tissue companies; now it is 1 in 8. Over the same period, the tissue enforcement staff has shrunk from 252 to 227.

Meanwhile, the list of companies or individuals handling tissue has quintupled in that time frame from 406 to 2,030.

"Anytime you've got a growing industry with high profits to be made and the cops are not on the beat and they know it, it opens the door to mischief," said William Hubbard, an FDA associate commissioner from 1991-2005.

The Bush Administration's proposed budget for the FDA warns of dire consequences if it doesn't get an extra $2.5 million and more inspectors: "Without this initiative, the American public risks an increase in preventable transmission of new and emerging infectious diseases."

With limited resources, the FDA targets companies it views as most risky to patients' health those that are high-volume and less reputable. FDA spokeswoman Julie Zawisza called it "the smartest way to do inspections."

But the agency didn't jump on the signs it saw at Biomedical Tissue Services in 2003. An inspector found problems with the way the New Jersey company kept records on how it disposed of "unsuitable" tissue. After BTS' chief promised the problems had been fixed, the FDA said it would verify that "during our next inspection."

The next inspection came too late after investigators found evidence the firm was shipping out thousands of unsuitable body parts with faked health records.

"FDA used to have a presence so that people thought, 'We ought to follow the rules because you know they'll be back,'" said Hubbard. "Now they know we're not likely to come the first time."

U.S. Rep. Frank Pallone, (D-N.J), has co-authored a bill to regulate tissue banks further. "I don't think there's much protection (for consumers) because there really isn't much government involvement. It's a crisis."

FDA officials contend tissues are adequately safe, tested and free of disease because of new flexible rules that went into force a year ago. Zawisza said the agency can't prevent "bad people" from breaking the law.

She and others point to the guidelines of the industry trade group, the American Association of Tissue Banks. But those guidelines are voluntary and the scandalized New Jersey company wasn't a member of that group.

James Forsell, the president of the tissue bank association, says the organization tries to keep the industry clean "through peer pressure."

"We don't have the ability to force anybody to do it," he said.]]>
Surgeries using cadaver tissue pose risks http://www.yourlawyer.com/articles/title/surgeries-using-cadaver-tissue-pose-risks Sat, 10 Jun 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/surgeries-using-cadaver-tissue-pose-risks
Four days after this routine, elective surgery, Lykins a healthy, 23-year-old student from Minnesota died of a raging infection.

He died because the cartilage came from a corpse that had sat unrefrigerated for 19 hours a corpse that had been rejected by two other tissue banks. The cartilage hadn't been adequately treated to kill bacteria.

None of this broke a single federal rule.

And it could happen again today likely is still happening today because of shoddy practices by some in the billion-dollar body parts business and the lack of government regulation.

The industry is in the news because a New Jersey company is accused of scavenging corpses without families' permission and then selling those parts to tissue processors. But apart from this scandal, thousands more Americans each day are put at risk in more insidious ways by legitimate tissue suppliers.

A three-month investigation by The Associated Press found problems ranging from inadequate testing for potentially deadly germs to lack of a unified system for tracking tissues as they travel from donor to recipient.

At every step from funeral homes, where the journey often begins, to hospitals and doctors' offices, where it ends with patients receiving the eyes, bones, skin and other parts of the dead poor oversight invites abuse and creates danger.

Most tissue transplants involve reputable companies and do a lot of good. Olympic skiers, people who have lost eyesight and children born with bad hearts are among the millions who have benefited. But when things go wrong, the consequences are horrific.

Ken Alesescu died May 14 in his San Luis Obispo, Calif., home, victim of a fungus-infested heart valve.

Alan Minvielle, of Santa Cruz, Calif., lost a job and almost lost a leg to gangrene from a bad tendon.

Bonny Gonyer in Chippewa Falls, Wis., has pain and walks with a limp because of tainted tissue.

"It angers me when I read these stories," Pam Alesescu, the heart valve recipient's widow, said in an interview shortly before he died. "My kids are losing their dad, and I am losing my husband."

The federal agency responsible for tissue safety, the Food and Drug Administration, is well aware of the problems. Yet, many experts believe the rules the FDA enacted last year as a long-promised overhaul fall short of providing the level of oversight needed.

Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses. Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses.

When it does inspect, public health isn't always protected. In 2003, an FDA inspector saw that Biomedical Tissue Services the now-notorious New Jersey company wasn't documenting what it did with tissue unsuitable for transplant. The FDA let the matter drop after the company sent a letter saying it had fixed the problem. For two more years, thousands of people received tissue.

"I'm not surprised that a BTS (incident) occurred. And there will be others," said Areta Kupchyk, a former FDA lawyer who drafted rules that ultimately were adopted in watered-down form. "We continue to be at risk."

Here are some of the ways:
  • A trade group, the American Association of Tissue Banks, requires accredited members to follow high standards, but without the FDA doing the same, hospitals and doctors can buy from unaccredited suppliers that offer tissue quicker or cheaper.
  • Tissue isn't tested as thoroughly as blood is for infectious diseases.
  • The FDA sets no limits on age or health of donors, or how long after death tissue can be taken.
  • Funeral homes don't have to report deaths to organ procurement groups, leaving them outside a regulatory system and able to cut side deals to supply body parts.
  • Doctors often know little about the origins of tissue they use. Some hospitals buy it like surgical gloves and other supplies based on price and availability. Patients are not always told they are receiving tissue from a cadaver or offered alternative treatments.
  • Hospitals and doctors do not have to report tissue infections to health officials, and evidence suggests that many are missed.
  • The FDA requires no medical training to run a tissue bank or procure tissue.
And business is booming.

The number of tissues distributed for transplants rose from 350,000 in 1990 to 650,000 in 1999 and 1.3 million in 2003. Tissue companies are awash in cash even the nonprofits. The biggest is the Musculoskeletal Transplant Foundation Inc. of New Jersey. In 2004, it had $243 million in revenues and paid its chief executive $542,212.

The FDA, on the other hand, lacks staff and money. It spends $5.4 million a year on tissue regulation less than two days' revenue for the industry. Inspections of tissue businesses peaked at 285 in 2004, but the number of companies rose from 1,325 two years ago to 2,030 now.

However, many gaps in oversight have nothing to do with resources, and stem instead from an FDA and Bush administration philosophy of not wanting to burden industry.

The FDA rules often state broad goals and let industry decide how to meet them. They say tissue should be tested for germs but do not specify the type or level of testing. Ditto for how tissue is disinfected. Some tissue, in fact, is not disinfected at all.

An FDA quality and compliance official, Mary Malarkey, said she believes tissue is safe and that she would have no qualms about receiving it.

"I do actually have family members and friends who have," Malarkey said. "I take that very seriously."

The trade association's president, James Forsell, said that most big companies are association members and that consumers are protected by his group's accreditation process.

When Lykins and others got contaminated tissue a few years ago from the Georgia-based bank, CryoLife Inc., that company was not accredited. Now it is, and company officials say they have several new testing and treatment procedures to prevent such problems.

If a non-member like BTS wants to falsify records or ignore proper procedures, "there is precious little that can be done," Forsell said.

Even doctors don't understand the risk of tissue they are using. "It comes in a nice package, it looks sterile," said Dr. Matthew Kuehnert, a tissue safety expert at the federal Centers for Disease Control and Prevention.

"Most physicians don't even know the questions to ask," said Dr. Ty Endean, a Tucson, Ariz., orthopedic surgeon. "They order tissue and they leave it up to the surgical center at their hospital. And those people are just going on price."

Often, the people who order tissue for operations don't know how it was treated or even all the companies that handled it. When the BTS scandal broke, some hospitals did not even realize their tissue had come from an unaccredited supplier.

Kuehnert wants a uniform system to trace tissue instantly from donor through processors to recipients.

"This is a daunting task, but it is doable," he said.

It's doable if people want it, says Steve Lykins, father of the Minnesota student who died.

"What the tissue companies did when Brian died was legal. The problem was, there were no laws out there to break," he said. "Any one of us could have opened a tissue bank in our garage. We could have hired the neighborhood kids who were interested in science to work for us."

Lykins and his wife, Leslie, have made many trips to Washington, lobbying for change.

"We didn't want to be sitting around watching TV and hear of another case where someone had lost a son like we lost Brian and know that we didn't do anything about it," he said. "We worked very hard for quite a while to encourage the FDA to start regulating this industry."
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Area residents file suit in looted body parts case http://www.yourlawyer.com/articles/title/area-residents-file-suit-in-looted-body-parts-case Tue, 23 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/area-residents-file-suit-in-looted-body-parts-case
The latest filings bring to eight the total number of lawsuits pending in Baton Rouge federal District Court.

The cases target Biomedical Tissue Service; a New York medical supply company that allegedly sold illegal and unscreened tissue and bone to Our Lady of the Lake Regional Medical Center and other unnamed hospitals in the state.

Owners Michael Mastromarino and Joseph Nicelli and others are accused of secretly carving up bodies from funeral parlors and city morgues and forging death certificates and organ-donor consent forms to make it appear as if the bones, skin, tendons, heart vales and other tissues were removed legally.

A Staten Island attorney who is representing Mastromarino and Biomedical Tissue Service has said his client “is just as taken aback as all these people are that he was misled.”

Filing suit are Graden and Diana McCool Jr. of East Baton Rouge Parish; and Daniel and Susan Ballard, Douglas and Genie Hoover, Steven and Velma Brock and Jack and Virgina Blacklock, all of Ascension Parish.

U.S. District Judge Frank Polozola has issued a stay in the cases until a decision is made on whether to consolidate them with others across the country.]]>
Gaps in system let ghoulish tale unfold http://www.yourlawyer.com/articles/title/gaps-in-system-let-ghoulish-tale-unfold Sun, 21 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/gaps-in-system-let-ghoulish-tale-unfold His career ravaged by narcotics addiction and a felony drug arrest, Dr. Michael Mastromarino, a New Jersey oral surgeon, agreed in 2002 to a suspension of his license to practice dentistry in New York state.

But just four days later, the New York state Department of Health granted him licenses to operate human tissue banks in Brooklyn. Mastromarino also registered his company with the U.S. Food and Drug Administration.

Mastromarino's company, Biomedical Tissue Services, closed down in October. He and three colleagues face 122 charges, including operating a criminal enterprise, forgery, grand larceny, body stealing and unlawful dissection of a human being. The charges stem from Biomedical's harvesting of tissue from 10 cadavers without getting consent from survivors and without screening for communicable diseases.

Biomedical operated unimpeded for more than two years before that criminal probe even began in November 2004, showing gaps in the systems that oversee the expanding human tissue industry, according to a Democrat and Chronicle investigation.

Over its first three years, Biomedical harvested tissue from about 1,075 cadavers and earned $4.6 million before the allegations came to light, prompting a recall of the human body parts it had distributed. That ongoing recall 15,672 tissues so far is far larger than any of the 343 other U.S. tissue recalls in the past decade.

The Biomedical recall came too late for thousands of patients in the United States, Canada, South Korea, Australia and other countries who were implanted with bones, skin, tendons or other tissue collected by the company before it ceased operations in October. More than a dozen people have claimed to have contracted communicable diseases from implantation of Biomedical-supplied tissue.

Biomedical's activities, including tissue recovery done in Rochester, remain under criminal investigation.

Here is what interviews and a review of public records show:

  • The FDA does not conduct background checks on owners or operators of tissue banks, nor does it lay out any minimum qualifications or standards.
  • New York requires tissue bank applicants to provide information about their background, including arrests and professional misconduct, and requires the Health Department to consider the "character and competence" of bank owners and operators. But Matromarino did not disclose his problems and state officials did not check.
  • Regulators conducted no inspections of Biomedical's facility during its first year and inspections afterwards failed to detect practices that regulators now allege were fraudulent and unsafe.

In Rochester, the scandal has resonated with particular strength. Not only did at least 60 area residents receive implants collected by Biomedical, but some collecting was done locally.

The company opened its sole branch office in Brighton in November 2004, and harvested tissue from as many as 65 cadavers in local funeral homes.

"I feel my dad's remains were what's the right word? defiled, I guess, or desecrated," said Don Ulp, a Greece resident who has been told by authorities that tissue was removed from his 84-year-old father's body without permission at a Hilton funeral home last year.

Ed VandeWater, a Williamson, Wayne County, resident, experienced similar feelings of violation after he learned in February that he had received a Biomedical bone implant in his neck.

"It makes you sick to see what this company was doing," he said. "How did nobody ever catch this?"

Background unchecked

Mastromarino, who had been an oral surgeon in New York and New Jersey since 1993, was arrested in July 2000 in New Jersey for drug possession and being under the influence of a controlled substance. His arrest followed a number of incidents, later documented in court filings, that were attributed to his illegal use of drugs. Mastromarino, 43, was stripped of his dentistry licenses in both states. But he quickly hit upon another way to earn a living: running a tissue bank.

He had used bone implants extensively in his oral surgery and had done research on the topic, said his lawyer, Mario Gallucci of Staten Island.

And the booming industry was in constant need of new sources of raw material: Between 1994 and 2003, the number of bones grafts distributed for implanation grew sixfold, to 1.3 million, said P. Robert Rigney, Jr., chief executive of the American Association of Tissue Banks.

By March 2002, Mastromarino and a partner had formed a tissue bank company, BioTissue Technologies Ltd., and were preparing to go into business.

Over the next few months, the company would be licensed by New York and registered with the FDA with regulators never showing awareness of Mastromarino's licensing woes, drug problems or arrest record.

To register with the FDA, a tissue bank operator need only fill out a one-page form, which asks for name and address, nothing more.

"FDA does not do background checks on owners or operators of tissue banks," said FDA spokeswoman Julie Zawisza. FDA rules also don't set minimum qualifications or standards for tissue bank operators but do say that employees must have the "necessary education, experience and training to ensure competent performance of their assigned functions."

The FDA reserves the right to check employees' background and training during inspections. But there is no mandatory inspection of a company when it begins operation, and there is no set interval at which inspections must be done.

FDA regulations do not require that tissue harvesters have the consent of survivors. McNeill said it is left to the states to create and enforcedonor-consent rules.

New York, one of the few states that regulates tissue banks, has a detailed license application that requires applicants to provide information about background. The application also asks about arrests and professional misconduct, and requires the Health Department to consider "character and competence.

In his application, a copy of which the Democrat and Chronicle obtained under the Freedom of Information Law, Mastromarino did not reveal anything about his drug arrest or the loss of his dental licenses.

Mastromarino answered no to a question about sustained or pending charges "of administrative violations of local, state or federal laws, rules and regulations concerning the provision of health care services or reimbursement for such services."

Asked whether Mastromarino should have discussed his dentistry problems in the application, Health Department spokesman Robert Kenny said he could not elaborate because it would be "subject to legal interpretation."

The Health Department would not speculate about whether Mastromarino's background would have disqualified him from operating a tissue bank, although spokeswoman Claire Pospisil said "a criminal conviction or sustained administrative charge related to operation of a health-care services site or funeral home is grounds for denial of a license."

A check with dentistry licensing officials in either state would have shown that Mastromarino had surrendered his license and the reason behind it but the Health Department did not make those checks, Kenny said.

"We didn't take action at that time. We had no reason to believe from his application that we would have to (check)."

Through his lawyer, Mastromarino declined to comment.

Mastromarino's tissue bank application was dated June 17, 2002.

On July 8, in a different setting in Albany, he admitted to the state dentistry board that he had practiced dentistry without a license in New York. A second charge, that of insurance fraud, was dropped. His license, which he had surrendered two years earlier, was formally suspended for four more years.

Four days after that, the Health Department issued him a provisional one-year tissue bank license.

Passing inspections

The opportunity for additional oversight went by the wayside as BioTissue opened.

State regulations require an inspection at the time a tissue bank opens.

But in the case of Mastromarino's company, that inspection was deferred because he moved the base of operations from Brooklyn to Fort Lee, N.J., shortly after the company began recovering tissue. He also transferred his licenses and registration from BioTissue to Biomedical Tissue Services.

Unlike most tissue recovery companies which are nonprofit and do their work in hospitals Biomedical was set up for-profit, and it harvested at funeral homes, which is not barred in New York state.

Biomedical's first inspection came a year after the company opened and had removed human bones, tendons and other tissue from roughly 200 cadavers and sold them for use in medical procedures.

Records indicate that on July 21, 2003, state Health Department inspector Tem Gonzalez, visited Biomedical's office in Fort Lee, N.J., looked around and spoke to Mastromarino. He directed Gonzalez to Daniel George and Son, a Brooklyn funeral home owned by his one-time partner in the tissue business, Joseph Nicelli.

Two days later, Gonzalez visited the funeral home, according to a written summary of his inspection obtained by the Democrat and Chronicle. He spoke with Nicelli, who told Gonzalez he offered families the option of tissue donation; Biomedical was summoned when a family consented.

Gonzalez also wrote that Nicelli told him the tissue collection was done in a second-floor room otherwise used for autopsies and body washing rituals.

"The room looks clean but not equipped with air filtration system or environmental control system," Gonzalez reported.

Sixteen months later, a New York City police detective, looking into financial irregularities at Daniel George, would discover the small room sparking an inquiry into Biomedical's tissue harvesting practices. That inquiry ultimately led to Biomedical's closure last fall, and to the indictment of Mastromarino, Nicelli and two other men Feb. 23 on charges they plundered human remains at Daniel George without consent.

The state Health Department was not aware in 2003 of any accusations of improprieties at Biomedical, said department spokesman Kenny, and had no reason to suspect any link between the second-floor room and the allegations that would surface later.

"Based on what we knew at the time, everything appeared to be legitimate," he said.

The inspector did cite the company for seven violations, including lack of involvement by Biomedical's medical advisory committee and its medical director, Dr. Mary Basco, a Virginia physician.

In retrospect, another citation for failure to keep a log of blood samples taken from donor cadavers is noteworthy. The samples are tested for evidence of certain infectious diseases as a way to ensure the tissue is safe for implantation.

Since the investigation of Biomedical has gone public, accusations have surfaced that the company submitted blood samples that came not from the cadavers, but from some other source.

Perhaps the most serious offense, though, was that Biomedical was overstepping its license, which permitted it to recover only musculoskeletal tissue bones and tendons, primarily.

Gonzalez had found that Biomedical also was taking skin and cardiovascular tissue heart valves, veins and the like from cadavers. The Health Department requires separate authorizations for each type of tissue recovery because the regulatory requirements differ between tissue types.

Biomedical submitted a corrective plan, which the Health Department accepted; no fines were assessed. Instead, regulators forwarded Biomedical an application for recovering cardiovascular tissue, to make lawful what it had been doing already.

By January 2004, the state Department of Health had awarded Biomedical a pair of full, four-year tissue bank licenses — one for tissue intended for implantation, the other for tissue to be used for research. Biomedical never harvested for research, records show.

Biomedical's business was booming. It had recovered tissue from 61 cadavers in 2002 and 240 cadavers in 2003, according to reports it filed with the Health Department.

By 2004, Biomedical was averaging more than one body a day. Its total that year 383 cadavers surpassed those reported by established nonprofit tissue agencies in Buffalo, Rochester, Syracuse and Albany.

Meanwhile, the FDA inspected Biomedical's facilities at least twice, according to Kevin Vickers of Honeoye, Ontario County, who worked as a tissue recovery specialist for Biomedical in New Jersey and later Rochester.

The agency's spokeswoman, Zawisca would not disclose whether the FDA ever inspected the company. But Vickers remembers being at the Fort Lee office in late 2004 when FDA inspectors undertook a four-day inspection of the company.

Vickers said the inspection, which he considered routine, resulted in Biomedical receiving "a clean bill of health." Gallucci said much the same. The FDA's Web site has no sanctions or warning letters to indicate otherwise.

One reason that repeated inspections did not uncover anything untoward may be that Biomedical, according to prosecutors and others, was engaged in rampant fraud forging signatures on donor consent forms, altering medical histories so that donors conformed with suitability rules, faking blood tests.

Records appeared to be in order when inspectors called; only afterward was the alleged fraud uncovered.

"That's part of our problem here," Rigney said. "This (tissue banks) organization has been in existence for 30 years, and we know of no such situation prior to this, where you have allegations that people forged donor consent forms and falsified medical information."

'Significant violations'

Tissue industry screening initially failed to halt troubling practices by Biomedical.

At least some of the five companies that purchased tissue specimens from Biomedical did their own audits of the company and tested its tissue, Rigney said.

Some processors ruled out some Biomedical tissue, he said. "It could have been bacteria, or quality of the bone."

But no one sounded the alarm on Biomedical until late September 2005, when New Jersey processor LifeCell Corp. reported it had found discrepancies in Biomedical's records.

That company and others quickly began a recall of all material that had come from Biomedical.

This time, the FDA acted quickly. After learning of the record discrepancies, it appeared at Biomedical's New Jersey office in early October for another inspection.

FDA inspectors spent more than three weeks at the task, which also included a review of records and visits to several funeral homes involved with Biomedical.

The company's New York licenses were "inactivated" on Oct. 14 after the scandal went public and a recall began of all tissue from Biomedical.

More than three months later, when the FDA summarized its findings, it ordered Biomedical to cease operations, and reported that it had uncovered "significant violations," most of which were attributed to inaccurate records.

Among the findings the agency cited on Jan. 31:

  • eight instances in which company records included false statements about a donor's age or cause of death.
  • three cases in which the records misstated where tissue recovery was done.
  • six instances in which it failed to disclose that a donor had been hospitalized.
  • two instances where records listed a fictitious spouse on a consent form.
  • two occasions in which records misstated the time between death and tissue recovery.
  • two cases in which records failed to indicate that autopsies had been done.
  • one instance in which Biomedical failed to ensure a funeral home had proper ventilation and refrigeration.
"These deficiencies, including your failure to create and maintain accurate records, are so serious and widespread that FDA finds there are reasonable grounds to believe that they present a danger to public health," the FDA stated.

Mastromarino intends to fight the closure order, said Gallucci, his lawyer, and also expects to prevail in Brooklyn criminal court.

An investigation into other dealings by Biomedical and its business associates in funeral homes including in Rochester is continuing. The Monroe County District Attorney's office also is looking into activities here.

FDA has said it is continuing its own inquiry into Biomedical's activities. The state Health Department is preparing new regulations to bar recovery of tissue in funeral homes, said Pospisil on Thursday. And bills have have been introduced in Congress and the state Senate to change the way tissue recovery is regulated.

For the everyday people who have been dragged into the macabre case, closure and reform can't come soon enough.

"I don't know who's responsible for the fact that it did go on for so long but there needs to be some sort of safeguard in terms of who's authorizing this (harvesting)," said Donald Ulp.

Ulp has been told by authorities that the body of his father, George Ulp, who died in February 2005 of Alzheimer's disease and colon cancer, was harvested for tissue without consent at the Burger Funeral Home in Hilton.

"Obviously, some series of checks and balances need to be put in place so that this doesn't happen again."]]>
Tissue bank facing new suit http://www.yourlawyer.com/articles/title/tissue-bank-facing-new-suit Sat, 20 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/tissue-bank-facing-new-suit
The family of Georgia A. Beaton, who died in a Rochester hospital in April 2005 at the age of 59, alleges in legal papers that Biomedical Tissue Services extracted tissue from her body.

They say they never gave consent for the procedure, and that a tissue-donation form authorizing the extraction bears a fraudulent signature.

Their lawsuit, filed Friday afternoon in state Supreme Court, accuses the Burger Funeral Home, owner Thomas E. Burger and funeral director Jason L. Gano of allowing Biomedical personnel to conduct the illegal tissue recovery.

Lawyers for Biomedical and Burger could not be reached for comment Friday. Neither could Beaton's lawyers. One family member, James Beaton, declined to comment on Friday.

Georgia Beaton's four adult children three daughters who live in the Rochester area and son James, who lives in Georgia constitute the seventh local family to make similar accusations against Biomedical and local funeral homes.

The operator of the New Jersey firm, Dr. Michael Mastromarino, and three associates were indicted in Brooklyn in February on charges they recovered tissue from bodies without obtaining consent and sold it for use in medical procedures without ensuring it was free of infectious disease.

The allegations in that 122-count indictment arose from the firm's activity in New York City, where Biomedical operated when it first opened for business in 2002.

Biomedical opened a branch office in suburban Rochester in November 2004 and recovered tissue from as many as 65 cadavers in local funeral homes.

The firm, which did all its tissue recovery work in funeral homes, had business relationships with up to eight local funeral homes, officials have said. Funeral directors were offered fees of $1,000 per body, according to several local directors.

Biomedical ceased operations here and elsewhere in October 2005 when accusations against it became public and questions arose about the accuracy of its records.

A criminal investigation of Biomedical's activities in Rochester, involving law enforcement agencies from Brooklyn and Monroe County, is continuing.

No criminal charges have been filed against any local funeral homes.

The Beaton family says in their legal papers they learned of the improper harvesting from an investigator in the Kings County District Attorney's office in Brooklyn.

Six other families had previously joined a proposed class-action lawsuit in federal court here that claims Biomedical recovered tissue without consent.

Four of those families say the unauthorized tissue recovery was done at the Burger home. The other families allege the misconduct occurred at Profetta Funeral Chapel in Irondequoit and Webster and at Serenity Hills Funeral Home in Rochester.
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Body Brokers: The Local Investigation http://www.yourlawyer.com/articles/title/body-brokers-the-local-investigation Thu, 18 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/body-brokers-the-local-investigation
They talked to 13WHAM News about the status of the investigation and allowed us to watch video of a raid on a local tissue bank office.

A New Jersey tissue bank operator and three of his associates have already been charged. Investigators say Michael Mastromarino, owner of New jersey-based Biomedical Tissue Services, trafficked stolen body parts from Brooklyn to Brighton.

Earlier this year, prosecutors estimated there are hundreds of victims. All of the victims are deceased, investigators say, and all are missing body parts. A dramatic moment during a news conference came when authorities showed an x-ray of a body that had plastic pipes inserted in the place of bones.

“It looks like the kitchen sink. It was just a horrible thing to look at and realize this person I never met was sitting there with bolts and pipes.  It was just shocking,” said Josh Hanshaft, a Brooklyn prosecutor.

On a snowy February day, Brooklyn investigators raided Biomedical’s Rochester office. At the time, Mastromarino knew he was under investigation, so authorities expected the office to be cleaned out.

They found coolers, used to store body parts and tissues. Investigators already had allegedly forged consent forms taken from other locations. The forms had Mastromarino’s signature.

In an exclusive interview with ABC News, Mastromarino said his signature only verifies that funeral directors had received family permission.
 
“Consent that we spoke to the funeral directors. We spoke to them and were allowed to move ahead with our procedures," he said.

Kings County Assistant District Attorney Josh Hanshaft said the forms indicate Mastromarino himself conducted the interviews with the families.

Hanshaft took 13WHAM News into what he calls his “war room” at his Brooklyn office. Charts on the wall link the similarities among thousands of documents.

Rochester has its own chart. Hanshaft confirmed for the first time that area funeral home directors are under investigation.

Eight Rochester-area funeral homes contracted with Biomedical Tissue Services to be part of the donation program. Hanshaft does not believe all were involved in criminal conduct. But each was paid $1,000 per body.

“There are certainly funeral home directors who are complicit and were aware of what was going on here, and partaking and profiting,” Hanshaft said.

Authorities estimate that, in Rochester, 50 to 60 bodies were robbed of tissues and other parts. Brooklyn prosecutors anticipate more arrests. They are working with the Monroe County District Attorney.

Who is Watching?
Journalist Annie Cheney has spent more than three years researching the billion-dollar body parts industry.

“(Family members are) grieving.  They expect the funeral director to take care of their loved one's body.  They expect their funeral director to respect their wishes,” said Cheney, author of “Body Broker.”

Cheney says a body is worth more in parts, than intact. Bones, tissues, and even whole spines, can generate $100,000 per body.

Cheney says no one is watching the industry closely.

“They don't address whether it’s appropriate to have a funeral home that also has a tissue business on site and the funeral home is involved with both businesses.  Because anyone could see there is a conflict of interest," she said.

New York does more than most states to regulate the industry. The health department must certify tissue banks, people who remove tissues, and the room where the procedure occurs. The room must also be sterile and separate from other funeral home activities.

But there are gaps in the regulations when it comes to cremation. All of the local stolen body parts cases involve cremation.

Lottie Kennedy died in Rochester home of heart failure. Her grieving daughters turned to a funeral home director recommended by a friend. Daughter Cyndia Kennedy McInnis said the Serenity Hills director collected the body himself.

“There was something going on and I saw it. I couldn't put my finger on it. But I mentioned it to my sister right there at my mom's house when he came to pick up the body,” said McInnis, who did not question the funeral home director.

McInnis learned in a phone call from investigators that her mother’s skin, tissues, and tendons were taken without permission.

"This total numbness came over me,” McInnis said.

McInnis is now suing the funeral home. She is represented by attorney Van White, who believes Lottie Kennedy was chosen for tissue harvesting because her body was set to be cremated.

“Michael Mastromarino figured out that investigators were onto him, so he was very selective about those bodies that he harvested. I believe that he required the bodies to be cremated so there wouldn't be any evidence of that activity,” White said.

Once a body leaves a hospital morgue, the state does little to regulate who has access to the body. Crematories are required to provide a receipt that a body was received, but the state does not track what happens to a body before it reaches its final destination.

"We've seen cases where they've gone to crematories and taken body parts out of a freezer and gone off with them. There's no way to tell if a head is missing or an arm is missing or a leg is missing,’" said Cheney

Every Part Has a Price
On the open market, every human part has a price. Though it’s illegal to sell a dead body, brokers can charge to recover the cost of removing storing, and transporting. Some brokers are cashing in.

"If you look at the people who were buying from Dr. Mastromarino, they even said in their stock statements to the SEC, 'Our raw materials may be hard to come by and that may impact your stock price.'  That would indicate to me they're really on the lookout for body parts and they're willing to cut corners to get them," Cheney said.

"There's no consent, there's no consent,” said Hanshaft. “It wasn't hard to figure out (Mastromarino) and the funeral home directors were skipping that.  They were just getting the body and getting the bones out."

Lottie Kennedy’s family has many questions.

"I do have reservations whether the urn that we have, are her remains.  As far as I know, there's no way of telling,” said McInnis.

Experts say it is difficult, if not impossible, to get a DNA profile of cremated remains.
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Bill sets jail term for body parts thieves http://www.yourlawyer.com/articles/title/bill-sets-jail-term-for-body-parts-thieves Wed, 17 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/bill-sets-jail-term-for-body-parts-thieves
The bill, A-3106, sponsored by Assemblywoman Valerie Vainieri Huttle (D-Englewood) and Dr. Herb Conaway Jr. (D-Burlington County), makes the illegal harvesting of body parts a first-degree crime punishable by 10 to 20 years in prison and a fine of up to $200,000.

The legislation was prompted by the uncovering of a massive body parts theft ring that authorities said was headed by Michael Mastromarino, a former dentist from Fort Lee. Mastromarino's firm, BioMedical Tissue Services, is accused of making millions of dollars by illegally harvesting tissue and bones from corpses.

"We want to make sure that families have peace of mind and that the utmost respect is shown for the remains of their loved ones," said Huttle, owner of Vainieri Funeral Home in North Bergen. "We also wanted to make sure that if this ever happened again, it would be a first-degree offense."

The bill also makes third-degree crimes of forging consent forms and other manipulation of donor paperwork, as well as the actual sale of a body part. Legitimate tissue recovery firms would still be able to charge for procuring the tissue.

Huttle said that in the wake of the BioMedical scandal, clients have shown trepidation about what might happen with their relatives' remains.

"There have been questions and concerns from families," she said.

Mastromarino, 42, and his partner, Joseph Nicelli, were indicted by a Brooklyn grand jury on Feb. 23 on charges of stealing bones and tissue from more than 1,000 corpses, including that of longtime "Masterpiece Theatre" host Alistair Cooke.

The pair and two accomplices made nearly $5 million from the scheme, authorities allege. They deny any wrongdoing and remain free on bail.

After unsealing the 122-count indictment, Brooklyn District Attorney Charles Hynes said Nicelli obtained the corpses from up to 40 funeral homes throughout the tri-state area and upstate New York with which he held contracts for embalming services.]]>
Sacred Heart issues advisory to all transplant recipients http://www.yourlawyer.com/articles/title/sacred-heart-issues-advisory-to-all-transplant-recipients Mon, 15 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/sacred-heart-issues-advisory-to-all-transplant-recipients
The parts came from New Jersey supplier Biomedical Tissue Services, whose owner has been indicted in Brooklyn with stealing body parts, forging consent and inspection documents and selling the unscreened human tissue to distributors.

Sacred Heart Medical Center was among thousands of hospitals being alerted by the Food and Drug Administration that some of its transplant body parts could be tainted with diseases.

So far, Sacred Heart has asked five patients who received tissue transplants in the last couple of years to get tested for HIV, Hepatitis B and C and Syphilis.

The hospital says the testing is just a precaution and that there is a good chance the patients aren't infected with any diseases.]]>
L.I. woman suing body-carve ghouls http://www.yourlawyer.com/articles/title/li-woman-suing-body-carve-ghouls Sat, 13 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/li-woman-suing-body-carve-ghouls
Pamela Grigorian, 48, of Middle Island, charges in a suit to be filed Monday that bone grafted onto her spine during a 2004 disk repair procedure was illicitly harvested by Michael Mastromarino and Joseph Nicelli.

Both men have been indicted by a Brooklyn grand jury for illegally carving up more than 1,000 corpses, then selling body parts for eventual transplant without testing the material for contagious diseases.

"I was extremely worried, but I have to be hopeful that I'm one of the lucky ones that won't get sick," said Grigorian referring to the risk of contracting HIV, hepatitis and other potentially fatal diseases associated with untested material culled from corpses.

Grigorian's suit also charges that Regeneration Technologies Inc., and Medtronic Sofamor Danek, USA, Inc., companies that bought skin, bone and other body parts from Mastromarino, also failed to adequately monitor material received by thousands of transplant recipients around the country.

The suit will be filed in Brooklyn Supreme Court, Grigorian's lawyer, Sanford Rubenstein said. He noted that although she has "tested negative for contagious disease so far, she could test positive for an illness in the future causing her ongoing emotional distress."

Mastromarino and Nicelli also have been charged with failing to obtain permission from next of kin before harvesting material from corpses. Their business, Biomedical Tissue Services Ltd., was shut down last fall after the Daily News disclosed the details of their grisly enterprise.
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Firm with Atlanta plant named in body parts suit http://www.yourlawyer.com/articles/title/firm-with-atlanta-plant-named-in-body-parts-suit Tue, 09 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/firm-with-atlanta-plant-named-in-body-parts-suit
Medicraft was named in a suit filed late Friday in Fulton County State Court by Darlean Adams, a Danielsville, Ga., woman who claims she received spinal grafts in February 2005 of material traced to the alleged New York scheme.

Adams claims in her suit that Medicraft "distributed the tainted allograft" that was implanted into her. She is seeking unspecified monetary damages.

Nearly 100 Atlanta area patients who received grafts of human tissue at six Atlanta area hospitals in the last two years have been told that the tissue may be diseased because it came from body parts stolen from funeral home corpses. The unidentified patients have been advised to be tested for HIV/AIDS, syphilis and hepatitis B and C because their graft material was not properly screened for the infections.

A Medicraft employee refused Monday to answer questions about Adams' lawsuit, but the firm's Web page indicated it manufactures sterile containers used to ship medical equipment and supplies.

A former New Jersey dental surgeon and three other men were indicted in February on charges that they secretly cut body parts from more than 1,000 funeral home corpses and sold them into the lucrative human tissue market.

Scores of lawsuits have been filed around the country by people who have been notified that the bone and tissue grafts they received over the past two years came from the alleged funeral home thefts.

Most of the lawsuits name the former dental surgeon, Michael Mastromarino, as a defendant, along with his company, Biomedical Tissue Services Inc., of Fort Lee, N.J., and several companies that received the material and processed it into products for use as grafts and implants.

After the alleged tissue harvesting scheme came to light, the Food and Drug Administration ordered companies that had received material from Biomedical Tissue Services to recall unused parts, and urged hospitals to have recipients tested for hepatitis, HIV-AIDS and syphilis.

Only a handful of recipients have said they contracted disease from the engrafted tissue.

Adams said her surgery took place at St. Mary's Hospital in Athens.

In a separate suit, Norman Zappa charged that spinal implants he received last June had been traced to the alleged harvesting scheme. Zappa's lawsuit, filed in DeKalb Superior Court in March, was shifted to U.S. District Court in Atlanta last week, records show.

In an interview Monday, Zappa said his surgery was performed at North Fulton Regional Hospital in Roswell. The hospital is not named in the suit.

Zappa, who said the surgery relieved pain he had experienced for more 30 years because of an industrial accident, has started an Internet forum for other patients who received questionable tissue.]]>
Alabama man says defective tissue transplanted in surgery http://www.yourlawyer.com/articles/title/alabama-man-says-defective-tissue-transplanted-in-surgery Tue, 09 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/alabama-man-says-defective-tissue-transplanted-in-surgery
The federal lawsuit filed Friday on behalf of Frank D. Fife alleges he received defective tissue from Biomedical Tissue Services, a New Jersey company closed by the Food and Drug Administration. The lawsuit says he received the tissue, including tendons in his neck, during a 2004 surgery at Medical Center East.

Because of problems with the transplant material, Fife underwent surgery to have the tissue replaced, according to his attorney, E. Glenn Waldrop Jr.

Michael Mastromarino, owner of the tissue company, has been charged by the Brooklyn district attorney's office as part of a scheme to steal thousands of body parts and sell the unscreened tissue for profit.

The suit names as defendants Biomedical Tissue, Mastromarino and Joseph Nicelli, an embalmer. Efforts to reach them were unsuccessful Tuesday. Both men have pleaded not guilty in the Brooklyn case.

The Birmingham suit also names Regeneration Technologies Inc. of Alachua, Fla., a tissue processor, as a defendant. A company representative was not immediately available Tuesday.

Fife's lawsuit doesn't make any claims against Medical Center East or Fife's doctors.

"They were deceived every bit as much as Mr. Fife," said Waldrop.]]>
Patients fear body tissue was tainted http://www.yourlawyer.com/articles/title/patients-fear-body-tissue-was-tainted Fri, 05 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/patients-fear-body-tissue-was-tainted
"It was very unsettling, it was scary, it was sickening," Lanham, 46, said of the letter she received on Jan. 10, informing her that bone tissue implanted as part of an August 2004 disk replacement might not have met U.S. Food and Drug Administration screening requirements.

The New Jersey company that provided the tissue, BioMedical Tissue Services, has been accused of illegally harvesting bone and other body tissue.

The FDA has ordered the company to cease all operations. And in February, the Brooklyn District Attorney indicted its executive director, Michael Mastromarino, and three others on 122 charges, including forgery, corruption, body stealing and opening graves.

In a case the New York media has branded as "body snatching," the indictment alleges the company doctored death certificates and forged consent forms to obtain body parts from people who had not consented or were too old or too ill to donate.

The company allegedly then sold the tissue to processors that shipped it to hospitals and doctor offices around the nation for use in such routine procedures as fracture repairs and back and neck surgeries.

Lanham is one of at least 200 people in Kentucky and Indiana who have been notified that their tissue implants, between early 2004 and September 2005, were obtained through BioMedical and they should be tested for such diseases as HIV, hepatitis and syphilis.

While there have been no reports of anyone locally testing positive for disease, some of the recipients have filed suit in Kentucky and Indiana. The FDA is investigating reports of possible infectious diseases in patients elsewhere, but would not provide details because of its ongoing investigation.

David Denkhoff who had back surgery at the Neurosurgical Institute of Kentucky in July 2004 and June 2005, is a plaintiff in a class-action lawsuit that a Louisville attorney filed in Jefferson Circuit Court against several defendants, including BioMedical.

"I thought it was safe," Denkhoff said of his tissue transplant. The accounting student at Jefferson Community College said that, while he's tested negative for infectious disease, he joined the suit in hopes that it will result in better regulation of the industry.

The attorney said he has about 10 plaintiffs. Court documents show that at least 172 people in Kentucky had tissue implanted that was provided by BioMedical. And at least two Indiana attorneys have filed suits.
Risk generally low

Annie Cheney, author of "Body Brokers: Inside America's Underground Trade in Human Remains," said tissue donation is "a much more involved process" than organ donation "and there is a lot more room for these types of problems."

But Bob Rigney, chief executive officer of the American Association of Tissue Banks, an industry group, disputes that, noting that the clinical criteria used for tissue and bone transplant are more extensive than those used for organs.

"The requirements for organ donation fill a few pages," he said, while requirements for tissue donation "fill a two-inch binder," in part because tissue and bone transplants generally are elective they are life-enhancing but not life-saving, as with organs.

The FDA has said it believes the risk to tissue recipients generally is low, although it's looking into whether changes need to be made to avoid situations like the one with BioMedical.

Rigney's group, which accredits member firms that handle and distribute tissue, said the chance of tissue spreading a disease is small because the companies that process and distribute it test and treat it to reduce the possibility of infection.

He also noted that out of 8 million to 10 million transplants in the past decade, there have been only a handful in which a patient contracted an infectious disease because of it.

Nearly all of the tissue distributed in the U.S. comes from banks accredited by Rigney's association. BioMedical is not one of them, but the tissue processors it distributed to are, he said.

"In 30 years, we have never had anything like this," Rigney said.
Testing urged

Once the alleged improper harvesting by BioMedical was discovered, the FDA and tissue processors recalled all unused materials and notified hospitals and doctors who received the products, recommending that patients be tested for possible infectious diseases.

After receiving her letter, Lanham informed Todd Leatherman, director of consumer protection for the Kentucky Attorney General. He began his own effort to ensure all affected Kentuckians knew to be tested.

He asked the five processors that received tissue from BioMedical to provide a list of all the places they distributed it in Kentucky and surrounding states. He then notified those facilities and urged them to encourage their patients to be tested.

Apparently not everyone has.

At the Spine Institute in Louisville, practice administrator Brenda Stewart said fewer than 30 of its patients were affected, and of those, fewer than half have checked with the office about testing.

At the Neurosurgical Institute of Kentucky in Louisville, 37 patients received donor bone tissue during the time period subject to recall, according to practice administrator Lenore Slawsky.

Slawsky said in an e-mail that about 20 percent of those have not returned for testing.

The fact that none of those tested have been found positive for infectious diseases due to the tissue does not ease the mind of Yvonne Lucas.

Lucas, of Chandler, Ind., said that learning about the potential problem from her neck surgery, done by Neurosurgical Institute in December 2004, has made her fearful about additional surgeries that her doctors say she should have.

"Since they've already gave me those tainted bones once," she said, "you don't know what you're going to have the next time."

Oba Ray, 67, of Owensboro, Ky., agreed the uncertainty is troubling.

Ray had back surgery at Neurosurgical Institute in June 2005, has been tested for diseases and all results have been negative. Still, he worries.

"There's that probability that maybe something will crop up down the road somewhere."
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Call it dark side of the corpse http://www.yourlawyer.com/articles/title/call-it-dark-side-of-the-corpse Fri, 05 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/call-it-dark-side-of-the-corpse
A corpse is a valuable commodity, and its parts can be worth more than the whole.

For example, knees, to be used for medical research and education, can cost $650 each. A whole torso for the same purpose costs $3,000.

And a whole cadaver can cost as much as $5,000.

Body parts used in surgery to replace diseased or injured parts in patients are even more valuable. A femur, or leg bone, used in cancer surgery goes for $5,000.

Because body parts are so lucrative and because the demand exceeds the supply the field is ripe for deception and theft.

That's allegedly how a Philadelphia funeral home became ensnared in the scandal roiling an industry that serves the noblest of missions and attracts the lowest of opportunists.

District attorneys in Brooklyn and in Philadelphia are investigating a ring in which funeral homes illegally sold to Biomedical Tissue Services of Fort Lee, N.J., parts of bodies and entire bodies destined for cremation or for private burial. These bodies were not screened for disease, and were taken without permission of next of kin, as regulations require.

Two Biomedical workers say that they were paid $300 or more for each corpse they dismembered at the Louis Garzone Funeral Home, on Somerset Street near Ruth, in Kensington.

Biomedical paid funeral homes between $500 and $1,000 for each body, and more than 1,000 bodies were involved, according to the Brooklyn D.A.

Biomedical, which allegedly netted $4.6 million over three years, sold these body parts to legitimate tissue banks that converted the material into bone paste, tissue used in surgical patients, and dental materials used for implants.

And loved ones never found out. The rest of the bodies apparently were cremated.

"You send a body for cremation and they harvest a couple knees and wrists and tendons, heart valves, tissue and you don't know," said Dr. Todd R. Olson, an anatomy professor at Albert Einstein College of Medicine in New York.

"There is no biochemical way to establish even that the ashes you receive are human, let alone whose. You can't do DNA testing. You paid them to take the body. Then, they take the bones and sell it."

As shocking as the allegations are, they aren't unique. A few rogue funeral homes have been accused before, according to Annie Cheney, author of "Body Brokers: Inside America's Underground Trade in Human Remains."

"Competition for bodies has led tissue companies to collaborate with funeral directors and brokers from the underground trade," she writes. "Together they are funneling bodies" into the tissue-industry pipeline.

Tissue can't be bought, sold

The illicit activity is outside the well-regulated practice of organ transplants, which still takes place relatively rarely and always in a well-scrutinized hospital setting when the donor is declared brain-dead.

And it is also beyond legitimate tissue transplant. Legitimate transplants of bone, skin, heart, valves and tendons is a billion-dollar business growing by 10 to 15 percent each year. Under the most stringent conditions, tissue can be harvested up to 24 hours after the heart stops.

It is illegal to buy and sell tissue, but tissue banks may charge "reasonable processing fees." This term has never been defined, and body brokers or for-profit tissue banks can set their own fees for body parts. These parts are sold to processors who make graft material to be used as bone, skin or tendons in surgeries. Other parts are sold for use in medical training and research.

There is suspicion within the tissue industry that "if more people knew that some processors are for-profit businesses, they would refuse to let for-profits process their donations, or refuse to donate tissue altogether," writes Indiana University law professor Robert A. Katz.

"Families want to do good," said Howard M. Nathan, president and chief executive of Gift of Life, the organ-and-tissue-donor program for this region.

Gift of Life sends its donated tissue to two nonprofit tissue processors. Gift of Life received about 48,000 referrals from hospitals last year. Of those, only about 1,400 qualified to be tissue donors and only 382 were organ donors.

The tissue-screening process is rigorous. Although tissue does not need to be genetically matched for transplant as a kidney must be compatible, for instance donors are screened to rule out old age or certain diseases.

"Tissues are used to repair a knee or a back. That is really an elective procedure. It is not life-saving," said Nathan. "That's why it has very tight screening criteria. If a donor died with a sexually transmitted disease or cancer, or engaged in a high-risk behavior, they are rejected."

Some donated bodies are used by medical and dental schools that need cadavers to teach students about human anatomy. Usually, these come from elderly people who will their bodies to science or to a specific medical school.

Humanity Gifts Registry in Center City supervises the geographic distribution of these donated bodies among Pennsylvania's schools. Last year, 634 adult bodies were donated statewide with one-third coming to this region. The deceased's family bears all but $50 of the cost to transport the body to the designated medical school, and the nonembalmed body must be transported within hours of death.

In this region, the five medical schools' demand for bodies always exceeds the supply. However, the registry never looks to replenish its supply outside of its direct donor pool.

"We stay away from body brokers," said executive director Bruce Hirsch. "Some of them appear to be shady. There have been too many stories about unclear trail of possession."

Safeguarding from scandal

In the Biomedical investigation, authorities allege that its owner, Michael Mastromarino, had forgeries made of family consent forms for donation, and of the decedents' age and cause of death.

The Biomedical scandal began when bodies were illegally dismembered in nonsterile funeral homes and sold to tissue processors. The U.S. Food and Drug Administration shut down Biomedical and alerted hospitals that bought graft tissue from these processors. That FDA notice, in turn, has spawned thousands of lawsuits from patients worried their implanted material is tainted.

Recently, an epidemiologist at the Centers for Disease Control said his investigation confirmed that some of the recipients had tested positive for HIV, hepatitis and syphilis, though he couldn't say how many and it may never be possible to know if they contracted the disease from the tissue.

Mastromarino has not responded to several calls for comment from the Daily News.

But two federal lawmakers have introduced legislation in the House and Senate to stop illegal trafficking in diseased body parts, creating new safeguards and oversight for the industry.

In the end, however, hospitals can be the most important watchdogs, said Gift of Life's Nathan.

"The reality is hospitals can buy tissue from any tissue bank that exists in the United States," said Nathan. "It is up to them to make sure that the tissue has been recovered and processed safely."]]>
Laws aim at body-parts traffic http://www.yourlawyer.com/articles/title/laws-aim-at-body-parts-traffic Thu, 04 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/laws-aim-at-body-parts-traffic
Dr. Arjun Scrinivasan, a medical epidemiologist at the Centers for Disease Control, said he could not tally the number of confirmed positive cases in the body-parts scandal, but may be able to do so in the next few weeks.

"Unfortunately, we may never be able to say whether those folks contracted the disease from the [BTS] tissue because of the forgeries in the case," said CDC spokeswoman Nicole Coffin, referring to apparent faked records.

As separate probes of the scandal proceed in Brooklyn, Philadelphia, at the CDC and at the Food and Drug Administration, U.S. Rep. Frank Pallone Jr., D-N.J., and U.S. Sen. Charles Schumer, D-N.Y., have introduced House and Senate versions of the "Safe Tissue Act" to stop the illegal trafficking in diseased body parts and create safeguards and oversight.

Their jurisdictions have been hardest hit by the revelations from the local and federal probe of BTS, based in Fort Lee, N.J., and a ring of more than 30 funeral homes that allegedly harvested body parts some of which were diseased without consent of the donors.

The tissue was then processed and implanted in unsuspecting recipients around the country.

Investigators from the Brooklyn district attorney's office and the FDA found that donors' medical records had been tampered with, citing changes to the donor's age and cause of death, as well as failure to list other diseases.

"It's very challenging to figure out," said Scrinivasan, who has been tracking the medical side of the issue since last October.

"Some of the blood samples did not come from the donors," he added. "How can we go back and determine a connection between a donor and an infection?"

"It's very unfortunate," the doctor said. "Our hearts go out to the people impacted by this. It's such a difficult thing to struggle with."

Scrinivasan is reviewing medical records and tracking down reports of patients who tested positive.

"We know that tissues were treated with a variety of methods to inactivate the risk of microorganisms that could create infection in transmitted tissue," he said. "So the risk of disease is low."

But even if a recipient tests positive, he or she may not have the disease, he said.

With hepatitis C, for example, a positive screening test would show antibodies, indicating the recipient had been exposed to the disease.

"But the body may have mounted a defense and fought it off," he added, "and there may be no virus present."

Doctors know how most diseases usually manifest in a patient the incubation, symptoms and recovery.

Syphilis symptoms are "quite delayed," as much as 18 months, he added. But if a diseased tissue is implanted, "this is all new" to doctors, he said.

The two bills propose a model donor form; an accreditation process for employees and businesses that recover, process, store, package or distribute tissue-based products; and inspecting or auditing tissue banks.

The Senate version also proposes civil penalties up to $5,000 and criminal penalties up to a $250,000 fine and 10 years in prison for a second offense.

Detectives from the Philadelphia D.A.'s office are investigating Louis Garzone Funeral Home in Kensington where two recovery technicians told the Daily News they extracted tissue from corpses and took it to BTS.]]>
As Scandal Widens, Many Who Received Stolen Body Parts and Human Tissue Claim to Have Been Infected with Deadly Viruses http://www.yourlawyer.com/articles/title/as-scandal-widens-many-who-received-stolen-body-parts-and-human-tissue-claim-to-have-been-infected-with-deadly-viruses Mon, 01 May 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/as-scandal-widens-many-who-received-stolen-body-parts-and-human-tissue-claim-to-have-been-infected-with-deadly-viruses
The victims claim that they had no risk factors that would explain their contracting diseases such as hepatitis, syphilis, or HIV/AIDS except for their receiving tissue transplants from the stolen body parts.

Several lawsuits have been commenced that seek class-action status on behalf of the hundreds, if not thousands, of recipients of the stolen tissue that has been recalled by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). There are also a number of personal injury suits being contemplated by individual patients who claim to have developed infections (AIDS, hepatitis, and syphilis) following their surgeries. At least two (Ohio and Nebraska) lawsuits are already filed that allege hepatitis as an injury.

Although it may turn out that some of the stolen tissue was, in fact, contaminated with various viruses, experts still see it as being difficult to connect specific infections with the donor tissue. The victims’ entire medical histories will need to be examined as will their personal habits, sexual relationships, and any risk factors that might also explain the infections.

One personal injury attorney we spoke with told us that “regardless of the seemingly obvious cause and effect between contaminated tissue and infections in otherwise healthy individuals who received that tissue, the plaintiffs will still need to prove the connection by more than mere circumstantial evidence. Solid medical proof will be needed to avoid possible dismissals. Gut reactions, no matter how obvious, will not be enough.”

As previously reported, the ghoulish tale of stolen body parts, missing persons, diseased human tissue grafts, and the possibility that thousands of innocent patients are now at risk of developing everything from HIV/AIDS and syphilis to hepatitis B and C has become a scandal of nationwide proportions that has health officials in several states as well as the FDA and CDC extremely concerned.

Hundreds of patients in several cities have been informed that human tissue grafts they received may have been from diseased body parts that were stolen from corpses in funeral homes and never properly screened for a wide range of serious and even life-threatening infectious diseases.

While warnings and recalls have been issued by the FDA and the CDC, this is really a case of the genie being out of the bottle since there is no way to remove the diseased tissue from the thousands of patients who may have unknowingly received it in the past two years.

The billion dollar body-part industry provided irresistible temptation to a group of unscrupulous criminals who bypassed all of the safety procedures in order to flood the market with potentially contaminated human tissue. Forged consents from family members, bogus documentation, and no regard for the cause of death of people who may have had serious or even fatal diseases, has placed an enormous number of people at risk.

While strict processing regulations with respect to screening, radiation, and treatment of body parts and human tissue with anti-bacterial and anti-viral drugs should prevent the spread of disease from infected products from the illegal sources, there is no guarantee that this will happen in all cases. In fact, it appears that precisely the opposite is true and that some patients have been infected by the diseased tissue.

New York, New Jersey, Pennsylvania, Alabama, Georgia, Tennessee, West Virginia, Florida, Ohio, Texas, and even an undisclosed number of foreign countries (including Canada) are among the places where thousands of problematic shipments of tainted human tissue may have been shipped.

Although the notion of hacking up the bodies of dead people following their funerals so that their body parts and tissue can be sold is quite revolting to the average person, the practice of illegal trafficking in human organs, body parts, and tissue has, like almost everything else, become big business. Moreover, without strict regulatory controls, it has become a business that anyone with a chain saw and a pickup truck can engage in according to one health official.

There is nothing new about this scandal, which has been developing for several years. For example, in March 2004, UCLA's Director of the Willed Body Program, Henry Reid, was arrested and a criminal investigation launched into the activities of others at the University of California for the illegal sale of body parts.

That series of events focused attention on the fact that one cadaver could be dismembered and sold in parts for over $200,000 to the pharmaceutical and medical industries.

It became shockingly clear that illegal “chop shops” were not confined to the stolen automobile trade. There was, in fact, an underground network of body part traders who utilized university medical centers as "fronts" for their ghoulish business.

Advances in surgery and other medical techniques also fueled an underground trade in transplantable tissues and organs that quickly became a multi-billion a year business.

Among the unspeakable horrors linked to this trafficking was the kidnapping of homeless children (for their transplantable tissues and organs) along the border between the U.S. and Mexico and the forced removal of organs from prisoners in third-world countries for sale in the U.S.

The probe of the UCLA Medical Center went back as far as 1998. Also arrested in March 2004 was Ernest Nelson, a body parts dealer who claimed to have paid Reid over $700,000 for permission to enter the UCLA body freezer and literally chop up some 800 cadavers and harvest their parts.

The cadavers stored at the university were supposed to be used exclusively by medical students for study. Nelson provided documentation to authorities that allegedly proved high level UCLA administrators had knowledge of and approved the secret sale of the body parts.

Reid, employees under his supervision, and others at the UCLA Medical Center appeared to have avoided detection by keeping some of the donated cadavers “off the books” and by possibly accepting cadavers that were never recorded.

At that time, there had been numerous reports of homeless persons vanishing from the downtown Los Angeles "Skid Row" area located close to UCLA. There had been unexplained disappearances of UCLA students as well. One of those students was 18-year-old freshman, Michael Negrete, who vanished from his dormitory on December 10, 1999, and has never been found.

The pharmaceutical and medical industries pay very well for a host of  body parts including skin, scalps, fingernails, tendons, heart valves, skulls and bones, which then find there way into research, manufacturing of drugs, and replacement surgery.

Medical device and instrument manufacturers often use these harvested body parts in training seminars for doctors.
In 2004, Johnson & Johnson was named in court documents as having contracted with Nelson for certain human tissue samples.
In addition to such scandals as the University of California Medical Center being used to "launder" cadaver parts, are numerous underground clinics that perform transplants involving illegally obtained organs.

It is suspected that many of these organs are being taken from children kidnapped along the U.S. border with Mexico and transplanted into wealthy American patients in underground clinics in Mexico and Texas.

The burgeoning trade in human organs was the focus of a 2003 film titled "Dirty Pretty Things." The film starred Audrey Tautou and was directed by Stephen Frears. It provided a glimpse into the hidden world of illegal immigrants and the trafficking in human organ that exploits their desperation for profit.

One of the serious problems with this illegal trafficking is that could result in the circumventing of  all screening and testing procedures set up and maintained to ensure recipients will not receive diseased or otherwise contaminated tissue or organs. With the possibility that dozens of unsuspecting patients could receive tissue or bone from a single diseased cadaver, the potential for a medical catastrophe cannot be minimized.  
 
All one needs to do is to consider the fact that, within the past few years,nine people have died as a result of receiving transplanted organs from only two donors infected with a rodent virus known as lymphocytic choriomeningitis virus (LCMV). Since human tissue samples may be dissected into hundreds of grafts, the problem of contamination is multiplied many times over.

Currently, the nationwide scandal had its origin in New York City. In Brooklyn, alone, some 1,000 corpses are part of the District Attorney's investigations into the theft and sale of bones and other body parts removed from fresh corpses at several funeral homes, without permission, and sold to BioMedical Tissue Services, a Fort Lee, N.J., tissue recovery company run by Michael Mastromarino.

Bones and body parts were replaced with everything from broomsticks and pipes to plumbing supplies. It is even being alleged that body parts from British actor and host of Masterpiece Theatre, Alistair Cooke were stolen and sold to BioMedical.  

These illegally removed body parts include bones for orthopedic procedures and dental implants, tendons and ligaments for those with tears or other damage, and skin for burn victims and cosmetic surgery.

Unfortunately, the tissue and bones were harvested without regard to the cause of death and without proper screening for diseases and other contamination.

As a result, Lifecell Inc. announced a voluntary recall of three products made from body parts acquired from BioMedical Tissue Services. They are AlloDerm, used for plastic surgery, burn and periodontal procedures; Repliform used for gynecological and urological surgical procedures; and GraftJacket, used for orthopedic applications and lower extremity wounds.

In addition, many medical facilities and hospitals have been forced to notify patients of the possibility that they may have contracted any one or more of a number of serious and even life-threatening diseases from the bone or tissue grafts they received.

North Shore-Long Island Jewish Health System, for example, telephoned and sent letters to 42 former patients advising them that they may have been exposed to potentially contaminated body parts. The letters state the hospital had indirectly received human bone, skin and tendons from BioMedical Tissue Services which may not have properly screened them for infectious diseases.

Health officials are concerned that tens of thousands of people across the country, and possibly more on Long Island, may have been exposed by untested parts from BioMedical.

BioMedical is already being sued by two New York families who claim a relative's body parts were stolen from the grave and sold to the New Jersey company. Hundreds are already being tested for various diseases.

Many of the body parts used on Long Island were purchased from BioMedical by a Florida tissue bank responsible for testing and sterilizing every body part it buys.

In an interview with Tucker Carlson on MSNBC, famed forensic pathologist Dr. Cyril Wecht discussed how something this ghoulish can happen in America.  

He stated that when bodies were sent to certain Brooklyn funeral homes for the necessary embalming, consent forms were forged giving permission to remove “various bones, tendons, ligaments, heart valves, teeth and so on.  Not major organs like heart and lungs and kidneys, because that just could not work.”

According to Wecht this isn’t the first time something like this has happened. “I’ve been involved in some cases over the years…they were doing this with eyes.  A funeral director tied in with an autopsy technician in a large hospital, and they were taking out people’s eyes and selling them to foreign countries.”

Dr. Wecht noted that in forging the necessary documents, ages and causes of death were changed. “They eliminated things like cancer and put in heart disease.”
 
In October, the Food and Drug Administration directed the recall of all tissue harvested by Biomedical. It also urged that recipients of tissue that originated with Biomedical be tested for communicable diseases.

Additional litigation has been commenced in the form of a class-action on behalf of the estates of the 1,000-plus victims. “The tissue and organs that have been removed from our beloved brothers, sisters, mothers, fathers, good friends – they’ve gone to other people who are now having these diseased parts in them,” said Dainis Zeltins, whose brother’s body parts were stolen.

Mastromarino’s lawyer maintains that his client believed the tissue and bone pieces were sterilized by his distributors, Regeneration Technologies Inc. and Tutogen Medical.  Mastromarino says “if they weren’t (sterilized), then that was the fault of the distributors who were sterilizing the tissue and cleaning it.”

Earlier this month there was an announcement that five additional families in the Rochester (New York) area have joined the federal lawsuit that accuses BioMedical of unlawfully harvesting body parts without consent.

The expanded lawsuit also alleges three more funeral homes aided the scheme by providing access to bodies and failing to obtain proper consent.

Since more and more people are coming came forward in response to the initial suit being filed on March 7, the attorney representing the plaintiffs will ask that the lawsuit be designated a class action, allowing it to move forward on behalf of multiple plaintiffs with similar allegations.

A Brooklyn grand jury has already indicted Mastromarino, his partner, Joseph Nicelli, and two other men.  Mastromarino ran BioMedical, Nicelli operated funeral homes, and the other men, Lee Crucetta and Chris Aldorasi, are alleged to have been the ones who cut up the bodies and replaced missing bones with creative carpentry and plumbing work.

Finally, as reported in nypress.com, there is an interesting angle to the story in terms of who was not named in the indictment; NYPD Detective Joseph Tully, Mastromarino’s business partner and operator of two funeral homes. Tully was also employed as a security guard at the Bronx County Medical Examiner’s office.

Although Tully appeared to be closely linked to the case, was named in the first two lawsuits, and was even the subject of an internal police department investigation, he has now mysteriously vanished from the matter. No public statement has been issued by the NYPD, Tully, or anyone else as to whether he was cleared of any culpability or still has some involvement.
As new reports of affected patients come in from health agencies in different cities and states as well as from the FDA and CDC, it has become clear that officials are dealing with the tip of one very large iceberg.
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Patients claim they caught viruses from stolen body parts http://www.yourlawyer.com/articles/title/patients-claim-they-caught-viruses-from-stolen-body-parts Sat, 29 Apr 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/patients-claim-they-caught-viruses-from-stolen-body-parts
The patients tested positive for germs that cause AIDS, hepatitis or syphilis after receiving tissue transplants, according to their lawyers and court records.

A New Jersey company, Biomedical Tissue Services, is accused of failing to gain consent to take bones, tendons, ligaments, skin and other tissue from cadavers.

At least 22 patients at Western North Carolina hospitals have received transplants of tissue that was recalled amid the Biomedical scandal.

On Friday, Mission Hospitals in Asheville and Haywood Regional Medical Center in Clyde said they have notified all patients involved and have not learned of any complications from the surgeries. They have not been warned they are the target of any lawsuits, according to Mission spokeswoman Merrell Gregory and Haywood Regional president David Rice.

Lawsuits have been filed for two Midwestern men, one in Nebraska and one in Ohio. Both claim they caught a hepatitis virus from the tissue implanted in back and spine operations a contention that lawyers acknowledge will be difficult to prove.

Lawyers for both men say they know of no other factors that would put their clients at risk for hepatitis.

“It pretty much turned my world upside down,” said one of the patients, Ned Jackson, 49, of Omaha, Neb.

The Associated Press talked to lawyers representing at least a dozen other clients who say medical tests show they have the AIDS or hepatitis virus or syphilis bacteria all of which can be acquired from infected tissue. Those suits have not yet been filed and the lawyers are continuing to investigate their claims.

So far, about two dozen lawsuits have been filed in federal courts across the country, most seeking class-action status for hundreds of people who were implanted with tissues that the U.S. government recalled.

About 1 million procedures a year involve implants of cadaver tissues.

The owner of Biomedical and three others have pleaded not guilty to the charges against them.]]>
Transplant patients claim they became ill from stolen body parts http://www.yourlawyer.com/articles/title/transplant-patients-claim-they-became-ill-from-stolen-body-parts Sat, 29 Apr 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/transplant-patients-claim-they-became-ill-from-stolen-body-parts
The patients tested positive for viruses that cause AIDS, hepatitis or syphilis after receiving tissue transplants, according to their attorneys and court records.

Lawsuits have been filed for two Midwestern men, one in Nebraska and one in Ohio. Both say they caught a hepatitis virus from the tissue implanted in back and spine operations a contention that attorneys acknowledge will be difficult to prove. Attorneys for both men say they know of no other factors that would put their clients at risk for hepatitis.

"It pretty much turned my world upside down," said one of the patients, Ned Jackson, 49, of Omaha, Neb.

So far, about 25 lawsuits have been filed in federal courts across the country, most asking for class-action status for hundreds of people who were implanted with tissues that the U.S. government recalled.

A New Jersey company, Biomedical Tissue Services, is accused of failing to get consent to take bones, tendons, ligaments, skin and other tissue from cadavers. The most famous example involved the body of Alistair Cooke, the longtime host of the PBS series Masterpiece Theater. Cooke died of cancer at 95, and his leg bones were removed and shipped to tissue processors for use in medical procedures.

About 1 million procedures a year involve implants of cadaver tissues. The companies that process the body parts for those surgeries say that their products are safe and believe that the case involving BTS of Fort Lee, N.J., is an aberration.

The owner of BTS and three others have pleaded not guilty to the charges against them. BTS has since closed. At least 8,000 people received BTS tissue, according to one of the tissue distributors.]]>
U.S. transplant patients file lawsuits in stolen body parts case http://www.yourlawyer.com/articles/title/us-transplant-patients-file-lawsuits-in-stolen-body-parts-case Sat, 29 Apr 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/us-transplant-patients-file-lawsuits-in-stolen-body-parts-case
The patients tested positive for organisms that cause AIDS, hepatitis or syphilis after receiving tissue transplants, said their lawyers and court records.

Lawsuits have been filed for two Midwestern men, one in Nebraska and one in Ohio. Both claim they caught a hepatitis virus from the tissue implanted in back and spine operations a contention lawyers acknowledge will be difficult to prove.

Lawyers for both men said they know of no other factors that would put their clients at risk for hepatitis.

"It pretty much turned my world upside down," said one of the patients, Ned Jackson, 49, of Omaha, Neb.

Lawyers representing at least a dozen other clients said medical tests show they have the AIDS or hepatitis virus or syphilis bacteria all of which can be acquired from infected tissue. Those suits have not yet been filed and the lawyers are continuing to investigate their claims.

So far, about two dozen lawsuits have been filed in federal courts across the United States, most seeking class-action status for hundreds of people who were implanted with tissues the U.S. government recalled.

A New Jersey company, Biomedical Tissue Services, is accused of failing to gain consent to take bones, tendons, ligaments, skin and other tissue from cadavers. The most famous example involved the corpse of Alistair Cooke, the longtime host of the PBS series Masterpiece Theater. Cooke died of cancer at age 95 and his leg bones were removed and shipped to tissue processors for use in medical procedures.

About one million procedures a year involve implants of cadaver tissues. The companies that process the body parts for those surgeries said their products are safe and believe the case involving Biomedical Tissue of Fort Lee, N.J., is an aberration.

The owner of BTS and three others have pleaded not guilty to the charges against them. BTS has since closed. At least 8,000 people received BTS tissue, said one of the tissue distributors.

The U.S. Food and Drug Administration has said the chance of contracting disease from BTS tissue is low. But plaintiff's lawyers are challenging that assertion.

"There has never been a widespread dissemination of recalled tissue. What's happened here presents a whole new scenario," said a lawyer, who's representing about 130 people who said they were given BTS tissue.

Steve Fogle thought the risk was low when he had spinal fusion surgery at Good Samaritan Hospital in Cincinnati on Aug. 29, 2005.

When the Blanchester, Ohio, man received a letter dated Dec. 9, 2005, from his doctor explaining the tissue that was implanted in his neck and spine might carry an infectious disease, he didn't think much about it.

The letter and other documents explained the tissue had been "terminally sterilized" and stated repeatedly the risk of infection was "low." The letter also said tissue had been recalled due to "improper documentation" and there were no reports of "adverse reactions."

Fogle, 41, felt reassured and put off testing for hepatitis, syphilis and HIV as recommended by the FDA.

Two months later, Fogle, who is married and has no tattoos or history of intravenous drug use risk factors for hepatitis C learned the true circumstances of the recall after watching a TV news report describing the macabre scandal.

The news from his test in Milford, Ohio, was not good: he was infected with Hepatitis C, his affidavit said.

A series of follow-up tests with his family doctor and a liver specialist confirmed the results. His wife's tests have been negative.

Testing positive for a germ does not necessarily mean someone will develop a disease. For example, many people who test positive for hepatitis C will test negative six months later if the body's immune system has defeated and cleared the virus.

Fogle declined comment but his lawyer, said Fogle should have been made fully aware of the allegations against BTS.

"The notice minimizes the risk in this case," Fogle's lawyer said.

"It appears when you read this letter it is a hypothetical risk. They downplayed the entire role of BTS."

Lawyers said the doctors and companies that processed and distributed the tissue diminished the risks in warning letters they sent to patients.

"People left the doctor's office thinking 'big deal,' it was a document error," said a New Jersey lawyer representing about 200 people who received the suspect tissue.

In Jackson's case, he had surgery on his lower back at Alegent Health Immanuel Medical Center in Omaha on Aug. 12, 2003. More than two years later, his doctor told him the tissue used in his surgery had been recalled.

Blood tests indicated Jackson, who's disabled, had contracted hepatitis B and C, the lawsuit said.

"To hear something like that is really upsetting," he said in a telephone interview.

Both Fogle and Jackson will have to prove their case if the companies involved decline to settle. Plaintiff's lawyers acknowledge proving it won't be easy. They'll have to generate extensive medical histories and cement the connection to BTS.

"The proof issues involved are certainly challenging," D'Arcy said.

Dr. Arjun Srinivasan, a medical epidemiologist with the Centers for Disease Control and Prevention, said his agency is investigating reports of positive test results in tissue recipients.

"It will be very difficult to determine with any certainty if there is any connection between the infection in the tissue recipient and the tissue donor," Srinivasan said.
]]>
Stolen Body Parts Scandal Leads to More Testing of Patients Who May Have Received Diseased Human Tissue Grafts http://www.yourlawyer.com/articles/title/stolen-body-parts-scandal-leads-to-more-testing-of-patients-who-may-have-received-diseased-human-tissue-grafts Sun, 23 Apr 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/stolen-body-parts-scandal-leads-to-more-testing-of-patients-who-may-have-received-diseased-human-tissue-grafts
Reports are now appearing that almost 100 more patients (this time in the Atlanta area) have been informed that human tissue grafts they received may have been from diseased body parts that were stolen from corpses in funeral homes and never properly screened for a wide range of serious and even life-threatening infectious diseases.

While warnings and recalls have been issued by the Food and drug Administration (FDA) and the Centers for disease Control and Prevention (CDC), this is really a case of the genie being out of the bottle since there is no way to remove the diseased tissue from the thousands of patients who may have unknowingly received it in the past two years.

The billion dollar body-part industry provided irresistible temptation to a group of unscrupulous criminals who bypassed all of the safety procedures in order to flood the market with potentially contaminated human tissue. Forged consents from family members, bogus documentation, and no regard for the cause of death of people who may have had serious or even fatal diseases, has placed an enormous number of people at risk.

While strict processing regulations with respect to screening, radiation, and treatment of body parts and human tissue with anti-bacterial and anti-viral drugs should prevent the spread of disease from infected products from the illegal sources, there is no guarantee that this will happen in all cases. In fact, it appears that precisely the opposite is true and that some patients have been infected by the diseased tissue.

Several law firms in a number of states have already commenced class-action lawsuits as well as individual actions in both federal and state courts around the U.S.  New York, New Jersey, Pennsylvania, Alabama, Georgia, Tennessee, West Virginia, Florida, Ohio, Texas, and even an undisclosed number of foreign countries (including Canada) are among the places where thousands of problematic shipments of tainted human tissue may have been shipped.

Although the notion of hacking up the bodies of dead people following their funerals so that their body parts and tissue can be sold is quite revolting to the average person, the practice of illegal trafficking in human organs, body parts, and tissue has, like almost everything else, become big business. Moreover, without strict regulatory controls, it has become a business that anyone with a chain saw and a pickup truck can engage in according to one health official.

As we previously reported, the scandal has been developing for several years. A logical starting point for a discussion of the problem, however, is March 2004 when UCLA's Director of the Willed Body Program, Henry Reid, was arrested and a criminal investigation launched into the activities of others at the University of California for the illegal sale of body parts.

That series of events focused attention on the fact that one cadaver could be dismembered and sold in parts for over $200,000 to the pharmaceutical and medical industries.

It became shockingly clear that illegal “chop shops” were not confined to the stolen automobile trade. There was, in fact, an underground network of body part traders who utilized university medical centers as "fronts" for their ghoulish business.

Advances in surgery and other medical techniques also fueled an underground trade in transplantable tissues and organs that quickly became a multi-billion a year business.

Among the unspeakable horrors linked to this trafficking was the kidnapping of homeless children (for their transplantable tissues and organs) along the border between the U.S. and Mexico and the forced removal of organs from prisoners in third-world countries for sale in the U.S.

The probe of the UCLA Medical Center went back as far as 1998. Also arrested in March 2004 was Ernest Nelson, a body parts dealer who claimed to have paid Reid over $700,000 for permission to enter the UCLA body freezer and literally chop up some 800 cadavers and harvest their parts.

The cadavers stored at the university were supposed to be used exclusively by medical students for study. Nelson provided documentation to authorities that allegedly proved high level UCLA administrators had knowledge of and approved the secret sale of the body parts.

Reid, employees under his supervision, and others at the UCLA Medical Center appeared to have avoided detection by keeping some of the donated cadavers “off the books” and by possibly accepting cadavers that were never recorded.

At that time, there had been numerous reports of homeless persons vanishing from the downtown Los Angeles "Skid Row" area located close to UCLA. There had been unexplained disappearances of UCLA students as well. One of those students was 18-year-old freshman, Michael Negrete, who vanished from his dormitory on December 10, 1999, and has never been found.

The pharmaceutical and medical industries pay very well for a host of  body parts including skin, scalps, fingernails, tendons, heart valves, skulls and bones, which then find there way into research, manufacturing of drugs, and replacement surgery.

Medical device and instrument manufacturers often use these harvested body parts in training seminars for doctors. In 2004, Johnson & Johnson was named in court documents as having contracted with Nelson for certain human tissue samples.

In addition to such scandals as the University of California Medical Center being used to "launder" cadaver parts, are numerous underground clinics that perform transplants involving illegally obtained organs.

It is suspected that many of these organs are being taken from children kidnapped along the U.S. border with Mexico and transplanted into wealthy American patients in underground clinics in Mexico and Texas.

The burgeoning trade in human organs was the focus of a 2003 film titled "Dirty Pretty Things." The film starred Audrey Tautou and was directed by Stephen Frears. It provided a glimpse into the hidden world of illegal immigrants and the trafficking in human organ that exploits their desperation for profit.

One of the serious problems with this illegal trafficking is that could result in the circumventing of  all screening and testing procedures set up and maintained to ensure recipients will not receive diseased or otherwise contaminated tissue or organs. With the possibility that dozens of unsuspecting patients could receive tissue or bone from a single diseased cadaver, the potential for a medical catastrophe cannot be minimized.    

All one needs to do is to consider the fact that, within the past few years, nine people have died as a result of receiving transplanted organs from only two donors infected with a rodent virus known as lymphocytic choriomeningitis virus (LCMV). Since human tissue samples may be dissected into hundreds of grafts, the problem of contamination is multiplied many times over.

Currently, the nationwide scandal had its origin in New York City. In Brooklyn, alone, some 1,000 corpses are part of the District Attorney's investigations into the theft and sale of bones and other body parts removed from fresh corpses at several funeral homes, without permission, and sold to BioMedical Tissue Services, a Fort Lee, N.J., tissue recovery company run by Michael Mastromarino.

Bones and body parts were replaced with everything from broomsticks and pipes to plumbing supplies. It is even being alleged that body parts from British actor and host of Masterpiece Theatre, Allistaire Cooke were stolen and sold to BioMedical.  

These illegally removed body parts include bones for orthopedic procedures and dental implants, tendons and ligaments for those with tears or other damage, and skin for burn victims and cosmetic surgery.

Unfortunately, the tissue and bones were harvested without regard to the cause of death and without proper screening for diseases and other contamination.

As a result, Lifecell Inc. announced a voluntary recall of three products made from body parts acquired from BioMedical Tissue Services. They are AlloDerm, used for plastic surgery, burn and periodontal procedures; Repliform used for gynecological and urological surgical procedures; and GraftJacket, used for orthopedic applications and lower extremity wounds.

In addition, many medical facilities and hospitals have been forced to notify patients of the possibility that they may have contracted any one or more of a number of serious and even life-threatening diseases from the bone or tissue grafts they received.

North Shore-Long Island Jewish Health System, for example, telephoned and sent letters to 42 former patients advising them that they may have been exposed to potentially contaminated body parts. The letters state the hospital had indirectly received human bone, skin and tendons from BioMedical Tissue Services which may not have properly screened them for infectious diseases.

Health officials are concerned that tens of thousands of people across the country, and possibly more on Long Island, may have been exposed by untested parts from BioMedical.

BioMedical is already being sued by two New York families who claim a relative's body parts were stolen from the grave and sold to the New Jersey company. Hundreds are already being tested for various diseases.

Many of the body parts used on Long Island were purchased from BioMedical by a Florida tissue bank responsible for testing and sterilizing every body part it buys.

In an interview with Tucker Carlson on MSNBC, famed forensic pathologist Dr. Cyril Wecht discussed how something this ghoulish can happen in America.  

He stated that when bodies were sent to certain Brooklyn funeral homes for the necessary embalming, consent forms were forged giving permission to remove “various bones, tendons, ligaments, heart valves, teeth and so on.  Not major organs like heart and lungs and kidneys, because that just could not work.”

According to Wecht this isn’t the first time something like this has happened. “I’ve been involved in some cases over the years…they were doing this with eyes.  A funeral director tied in with an autopsy technician in a large hospital, and they were taking out people’s eyes and selling them to foreign countries.”

Dr. Wecht noted that in forging the necessary documents, ages and causes of death were changed. “They eliminated things like cancer and put in heart disease.”  

In October, the Food and Drug Administration directed the recall of all tissue harvested by Biomedical. It also urged that recipients of tissue that originated with Biomedical be tested for communicable diseases.

Additional litigation has been commenced in the form of a class-action on behalf of the estates of the 1,000-plus victims. “The tissue and organs that have been removed from our beloved brothers, sisters, mothers, fathers, good friends they’ve gone to other people who are now having these diseased parts in them,” said Dainis Zeltins, whose brother’s body parts were stolen.

Mastromarino’s lawyer maintains that his client believed the tissue and bone pieces were sterilized by his distributors, Regeneration Technologies Inc. and Tutogen Medical.  Mastromarino says “if they weren’t (sterilized), then that was the fault of the distributors who were sterilizing the tissue and cleaning it.”

Earlier this month there was an announcement that five additional families in the Rochester (New York) area have joined the federal lawsuit that accuses BioMedical of unlawfully harvesting body parts without consent.

The expanded lawsuit also alleges three more funeral homes aided the scheme by providing access to bodies and failing to obtain proper consent.

Since more and more people are coming came forward in response to the initial suit being filed on March 7, the attorney representing the plaintiffs will ask that the lawsuit be designated a class action, allowing it to move forward on behalf of multiple plaintiffs with similar allegations.

A Brooklyn grand jury has already indicted Mastromarino, his partner, Joseph Nicelli, and two other men. Mastromarino ran BioMedical, Nicelli operated funeral homes, and the other men, Lee Crucetta and Chris Aldorasi, are alleged to have been the ones who cut up the bodies and replaced missing bones with creative carpentry and plumbing work.

Finally, as reported in nypress.com, there is an interesting angle to the story in terms of who was not named in the indictment; NYPD Detective Joseph Tully, Mastromarino’s business partner and operator of two funeral homes. Tully was also employed as a security guard at the Bronx County Medical Examiner’s office.

Although Tully appeared to be closely linked to the case, was named in the first two lawsuits, and was even the subject of an internal police department investigation, he has now mysteriously vanished from the matter. No public statement has been issued by the NYPD, Tully, or anyone else as to whether he was cleared of any culpability or still has some involvement.

As new reports of affected patients come in from health agencies in different cities and states as well as from the FDA and CDC, it has become clear that officials are dealing with the tip of one very large iceberg. Massive federal and state civil actions as well as major criminal prosecutions promise to keep this nightmarish story in the headlines for years to come.
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Body-parts probe expands http://www.yourlawyer.com/articles/title/body-parts-probe-expands Tue, 18 Apr 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/body-parts-probe-expands
In the past week, investigators have interviewed at least two tissue-recovery technicians from the now defunct Biomedical Tissue Services Inc. who say that they extracted bones, veins and tendons from corpses of deceased Philadelphians, according to several sources close to the investigation.

Late last month, Philadelphia investigators paid a surprise visit to employees at Louis Garzone Funeral Home and questioned workers for several hours, said one source.

The D.A.'s office is trying to determine how many local corpses were dissected, how much money was exchanged for the work, and how Garzone began its relationship with the Fort Lee, N.J., biomedical-tissue company, sources said.

Assistant District Attorney Joseph Zaffarese asked that "anyone with information regarding this investigation or anyone who believes a family member has been victimized" contact his office.

But Zaffarese declined to discuss any details of the case.

The special-investigations unit of the D.A.'s office opened its investigation after the Daily News reported that the Kensington funeral home was linked to the probe by the Brooklyn district attorney's office.

Brooklyn prosecutors have said that up to 30 funeral homes in New York, New Jersey and Philadelphia supplied body parts, possibly tainted, to Biomedical Tissue Services without seeking consent from the deceased persons' families.

In February, the Brooklyn D.A. brought indictments against Biomedical owner Michael Mastromarino and his partner, Joseph Nicelli, and two tissue-recovery specialists, Lee Cruceta and Christopher Aldorasi.

Philadelphia funeral director Louis Garzone, 63, was not named in the Brooklyn indictment and did not return a phone message last night from the Daily News.

Early last week, local prosecutors traveled to New York City to meet with former Biomedical worker Cruceta, Cruceta's lawyer said.

Cruceta recently said that he had cut up bodies at Garzone's parlor, on Somerset Street near Ruth, from February 2004 to last September.

"He is not hiding the fact that he worked in the Garzone funeral home," said George Vomvolakis, Cruceta's attorney. Cruceta also worked in parlors in Brooklyn, Manhattan and Rochester, Vomvolakis said.

On Thursday, Cruceta's ex-colleague, Kevin Vickers, said he had driven from his home outside Rochester, N.Y., to Philadelphia to meet with prosecutors.

Vickers declined to share what had been discussed during his visit, saying he was following investigators' orders by not talking openly about the case.

But Vickers told the Daily News earlier this year that he had dissected dozens of bodies at Garzone during the last two months of 2004. Vickers was not named in the Brooklyn indictment.

New York City police learned about Biomedical's eerie partnership with the funeral homes in November 2004, after a detective discovered an operating room in a Brooklyn parlor used by the firm to carve tissue from corpses.

Eleven months later, the U.S. Food and Drug Administration began its investigation into Biomedical. It closed down the tissue company in February, citing it for not properly screening the body parts for disease.

Biomedical sold parts to unknowing tissue banks across the country that used them for tissue transplants for trusting patients, Brooklyn prosecutors said. Some of the parts also were turned into bone paste, skin grafts and dental implants.

Regionally, 16 surgical patients here and 78 at the Jersey shore have been notified that they may have received contaminated tissue.

Cruceta and his three colleagues have pleaded not guilty to the Brooklyn charges, which include body-stealing, unlawful dissection and forgery.

They all are free on bail ranging from $250,000 to $1.5 million.

It is not illegal in New York to remove tissue from corpses inside a funeral home, but in Pennsylvania, only corneas can be taken from corpses inside funeral homes.

Sources said Philadelphia prosecutors are aggressively investigating why Garzone allegedly ignored the state rule.

Both Vickers and Cruceta said they were clueless about Pennsylvania laws and had just been following their bosses' directions to work on bodies at Garzone's.

"He was shocked," said Vomvolakis, describing Cruceta's reaction when a reporter informed him about the Pennsylvania law after a recent Brooklyn court hearing on his case.

"He has no idea," Vomvolakis said.]]>
Illegal Body Parts Used For Oklahoma Patients http://www.yourlawyer.com/articles/title/illegal-body-parts-used-for-oklahoma-patients Mon, 10 Apr 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/illegal-body-parts-used-for-oklahoma-patients
Susan Fisher, 36, of Okmulgee, and Priscilla Loveland, 52, of Cushing, were among those who received certified letters from Oklahoma hospitals notifying them that the bones used in their surgeries were part of a ``recall.''

``I was flabbergasted,'' Loveland told The Oklahoman. ``This is a scary deal.''

Unapproved bone tissue secretly taken from untested corpses on the East Coast had been inserted in their necks 10 months earlier, they were told. They should be tested to see whether they had contracted HIV, hepatitis or syphilis.

Federal Food and Drug Administration officials refused to say how many Oklahomans received the potentially tainted body parts during surgeries that took place from early 2004 through September 2005.

The story broke in February when New York prosecutors filed a 122-count indictment that accused the owner of Biomedical Tissue Services, a New Jersey biomedical firm, and three other people of stealing cadaver body parts from a Brooklyn funeral home and selling them for use in surgeries.

Prosecutors allege the stolen body parts included bones, tendons, heart valves, skin and other tissue, prosecutors said.

Several civil lawsuits have been filed nationwide in connection with the case, including a federal court lawsuit in Tulsa.

At the request of the federal Food and Drug Administration, five tissue processing companies that received material from Biomedical Tissue Services voluntarily recalled all unused tissue obtained from that source. Processing companies clean and sterilize tissue before it is sent to distributors for sale to hospitals.

The FDA also recommended that doctors who had implanted the tissue notify their patients and provide them access to appropriate infectious disease testing.

Hillcrest of Tulsa is one of the hospitals that notified its patients, hospital spokeswoman Sally Huggins confirmed.

Fisher said she felt stunned Feb. 16 when she opened a certified letter from Hillcrest and read that the bone pieces that had been implanted in her neck April 11 were part of a recall.

``They used that word, 'recall,''' she said.

The notice was accompanied by a packet of information that offered free blood testing and said the FDA considered risks to be low, because the tissue had undergone routine sterilization procedures.

Loveland declined to say where she had her surgery, saying she didn't fault the doctor or hospital because they had no way of knowing that the bones had been obtained illegally.]]>
Illegal Harvesting and Sale of Body Parts, Tissue, and Organs- Dr. Frankenstein Would Have Been Proud http://www.yourlawyer.com/articles/title/illegal-harvesting-and-sale-of-body-parts-tissue-and-organs-dr-frankenstein-would-have-been-proud Sat, 08 Apr 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/illegal-harvesting-and-sale-of-body-parts-tissue-and-organs-dr-frankenstein-would-have-been-proud
Whether the goal was to create a monster like Frankenstein or to dabble in macabre experiments in a dimly lit 19th century medical school, audiences were revolted by the very notion of dead bodies being violated and mutilated once they had been laid to rest.

Today, you can rent those grainy black-and-white movies and wonder what all the fuss was about or you can really be nauseated by simply opening your daily newspaper, turning on your TV, or listening to the radio. Now, the revolting practice of illegal trafficking in human organs, body parts, and tissue has, like almost everything else, become big business.

While the scandal has been developing for several years, a logical starting point for a discussion of the problem is March 2004 when UCLA’s Director of the Willed Body Program, Henry Reid, was arrested and a criminal investigation launched into the activities of others at the University of California for the illegal sale of body parts.

That series of events focused attention on the fact that one cadaver could be dismembered and sold in parts for over $200,000 to the pharmaceutical and medical industries.

It became shockingly clear that illegal “chop shops” were not confined to the stolen automobile trade. There was, in fact, an underground network of body part traders who utilized university medical centers as “fronts” for their ghoulish business.

Advances in surgery and other medical techniques also fueled an underground trade in transplantable tissues and organs that quickly became a multi-billion a year business.

Among the unspeakable horrors linked to this trafficking was the kidnapping of homeless children (for their transplantable tissues and organs) along the border between the U.S. and Mexico and the forced removal of organs from prisoners in third-world countries for sale in the U.S.

The probe of the UCLA Medical Center went back as far as 1998. Also arrested in March 2004 was Ernest Nelson, a body parts dealer who claimed to have paid Reid over $700,000 for permission to enter the UCLA body freezer and literally chop up some 800 cadavers and harvest their parts.

The cadavers stored at the university were supposed to be used exclusively by medical students for study. Nelson provided documentation to authorities that allegedly proved high level UCLA administrators had knowledge of and approved the secret sale of the body parts.

Reid, employees under his supervision, and others at the UCLA Medical Center appeared to have avoided detection by keeping some of the donated cadavers “off the books” and by possibly accepting cadavers that were never recorded.

At that time, there had been numerous reports of homeless persons vanishing from the downtown Los Angeles “Skid Row” area located close to UCLA. There had been unexplained disappearances of UCLA students as well. One of those students was 18-year-old freshman, Michael Negrete, who vanished from his dormitory on December 10, 1999, and has never been found.

The pharmaceutical and medical industries pay very well for a host of body parts including skin, scalps, fingernails, tendons, heart valves, skulls and bones, which then find there way into research, manufacturing of drugs, and replacement surgery.

Medical device and instrument manufacturers often use these harvested body parts in training seminars for doctors.

In 2004, Johnson & Johnson was named in court documents as having contracted with Nelson for certain human tissue samples.

In addition to such scandals as the University of California Medical Center being used to “launder” cadaver parts, are numerous underground clinics that perform transplants involving illegally obtained organs.

It is suspected that many of these organs are being taken from children kidnapped along the U.S. border with Mexico and transplanted into wealthy American patients in underground clinics in Mexico and Texas.

The burgeoning trade in human organs was the focus of a 2003 film titled “Dirty Pretty Things.” The film starred Audrey Tautou and was directed by Stephen Frears. It provided a glimpse into the hidden world of illegal immigrants and the trafficking in human organ that exploits their desperation for profit.

One of the serious problems with this illegal trafficking is that it circumvents all screening and testing procedures set up and maintained to ensure recipients will not receive diseased or otherwise contaminated tissue or organs. With the possibility that dozens of unsuspecting patients could receive tissue or bone from a single diseased cadaver, the potential for a medical catastrophe cannot be minimized.

All one needs to do is to consider the fact that, within the past few years, nine people have died as a result of receiving transplanted organs from only two donors infected with a rodent virus known as lymphocytic choriomeningitis virus (LCMV).

Currently, a scandal with nationwide implications is unfolding in New York City. In Brooklyn, alone, some 1,000 corpses are part of the District Attorney’s investigations into the theft and sale of bones and other body parts removed from fresh corpses at several funeral homes, without permission, and sold to BioMedical Tissue Services, a Fort Lee, N.J., tissue recovery company run by Michael Mastromarino.

Bones and body parts were replaced with everything from broomsticks and pipes to plumbing supplies. It is even being alleged that body parts from British actor and host of Masterpiece Theatre, Allistaire Cooke were stolen and sold to BioMedical.

These illegally removed body parts include bones for orthopedic procedures and dental implants, tendons and ligaments for those with tears or other damage, and skin for burn victims and cosmetic surgery.

Unfortunately, the tissue and bones were harvested without regard to the cause of death and without proper screening for diseases and other contamination.

As a result, Lifecell Inc. announced a voluntary recall of three products made from body parts acquired from BioMedical Tissue Services. They are AlloDerm, used for plastic surgery, burn and periodontal procedures; Repliform used for gynecological and urological surgical procedures; and GraftJacket, used for orthopedic applications and lower extremity wounds.

In addition, many medical facilities and hospitals have been forced to notify patients of the possibility that they may have contracted any one or more of a number of serious and even life-threatening diseases from the bone or tissue grafts they received.

North Shore-Long Island Jewish Health System, for example, telephoned and sent letters to 42 former patients advising them that they may have been exposed to potentially contaminated body parts. The letters state the hospital had indirectly received human bone, skin and tendons from BioMedical Tissue Services which may not have properly screened them for infectious diseases.

Health officials are concerned that tens of thousands of people across the country, and possibly more on Long Island, may have been exposed by untested parts from BioMedical.

BioMedical is already being sued by two New York families who claim a relative’s body parts were stolen from the grave and sold to the New Jersey company. Hundreds are already being tested for various diseases.

Many of the body parts used on Long Island were purchased from BioMedical by a Florida tissue bank responsible for testing and sterilizing every body part it buys.

In an interview with Tucker Carlson on MSNBC, famed forensic pathologist Dr. Cyril Wecht discussed how something this ghoulish can happen in America.

He stated that when bodies were sent to certain Brooklyn funeral homes for the necessary embalming, consent forms were forged giving permission to remove “various bones, tendons, ligaments, heart valves, teeth and so on. Not major organs like heart and lungs and kidneys, because that just could not work.”

According to Wecht this isn’t the first time something like this has happened. “I’ve been involved in some cases over the years…they were doing this with eyes. A funeral director tied in with an autopsy technician in a large hospital, and they were taking out people’s eyes and selling them to foreign countries.”

Dr. Wecht noted that in forging the necessary documents, ages and causes of death were changed. “They eliminated things like cancer and put in heart disease.”

In October, the Food and Drug Administration directed the recall of all tissue harvested by Biomedical. It also urged that recipients of tissue that originated with Biomedical be tested for communicable diseases.

Additional litigation has been commenced in the form of a class-action on behalf of the estates of the 1,000-plus victims. “The tissue and organs that have been removed from our beloved brothers, sisters, mothers, fathers, good friends they’ve gone to other people who are now having these diseased parts in them,” said Dainis Zeltins, whose brother’s body parts were stolen.

Mastromarino’s lawyer maintains that his client believed the tissue and bone pieces were sterilized by his distributors, Regeneration Technologies Inc. and Tutogen Medical. Mastromarino says “if they weren’t (sterilized), then that was the fault of the distributors who were sterilizing the tissue and cleaning it.”

Only yesterday came the announcement that five additional families in the Rochester (New York) area have joined the federal lawsuit that accuses BioMedical of unlawfully harvesting body parts without consent.

The expanded lawsuit also alleges three more funeral homes aided the scheme by providing access to bodies and failing to obtain proper consent.

Since more and more people are coming came forward in response to the initial suit being filed on March 7, the attorney representing the plaintiffs will ask that the lawsuit be designated a class action, allowing it to move forward on behalf of multiple plaintiffs with similar allegations.

A Brooklyn grand jury has already indicted Mastromarino, his partner, Joseph Nicelli, and two other men. Mastromarino ran BioMedical, Nicelli operated funeral homes, and the other men, Lee Crucetta and Chris Aldorasi, are alleged to have been the ones who cut up the bodies and replaced missing bones with creative carpentry and plumbing work.

Finally, as reported in nypress.com, there is an interesting angle to the story in terms of who was not named in the indictment; NYPD Detective Joseph Tully, Mastromarino’s business partner and operator of two funeral homes. Tully was also employed as a security guard at the Bronx County Medical Examiner’s office.

Although Tully appeared to be closely linked to the case, was named in the first two lawsuits, and was even the subject of an internal police department investigation, he has now mysteriously vanished from the matter. No public statement has been issued by the NYPD, Tully, or anyone else as to whether he was cleared of any culpability or still has some involvement.

Based upon the revelations so far in this case and the problem of illegal harvesting of body parts, tissue, and bones in general, there promises to be years of criminal prosecutions, civil lawsuits, and revelations that would make Dr. Frankenstein proud.

(*Assisted by Eileen Farrell, a Communications Major at St. Francis College)]]>
Untested Body Parts Side Effects Lawsuits | Side Effects: Risk of Developing Infectious Diseases, Risks of HIV, Hepatitis B, Hepatitis C, Syphilis | Fraudulent Documents, Untested Tissue, Illegal Sale of Untested Body Parts http://www.yourlawyer.com/topics/overview/untested_body_parts Sat, 08 Apr 2006 00:00:00 -0400 http://www.yourlawyer.com/topics/overview/untested_body_parts Untested Body Parts Side Effects Could Lead To Infectious Disease Lawsuits

Untested Body Parts | Lawsuits, Lawyers | Side Effects: Risk of Developing Infectious Diseases, Risks of HIV, Hepatitis B, Hepatitis C, Syphilis | Fraudulent Documents, Untested Tissue, Illegal Sale of Untested Body Parts

Illegal Sale Of Untested Body Parts & Tissue

Thousands of patients who underwent tissue, bone and organ transplants are at risk of developing serious diseases due to the use of untested body parts. Recent criminal charges detailed the illegal sale of untested body parts and tissue to hospitals, distributors and medical device manufacturers. The FDA is concerned that the recipients of untested body parts and tissues are potentially at risk of developing HIV, Hepatitis B, Hepatitis C, Syphilis and other infectious diseases.

The untested body parts and tissue scandal centers around Biomedical Tissue Services, which allegedly acquired body parts without donor permission and sold them for use in transplants performed at hospitals and other medical facilities within the United States. The owner and three other employees of Biomedical Tissue Services have been indicted in Brooklyn, New York for taking body parts without legal consent and without proper screening. It is believed that funeral home operators accepted money from the company in exchange for ignoring obviously forged death certificates and consent forms. The body parts and tissue in question have been distributed throughout the country and used in thousands of operations.

Biomedical Tissue Services sold these illegal body parts to several large companies including Lifecell Corp., Regeneration Technologies, Inc., Tutogen Medical, Inc., Lost Mountain Tissue Bank and Blood & Tissue Center of Central Texas. The FDA and most of the companies involved have not disclosed the number of patients that received the untested parts and tissue.

Untested Body Parts Scandal - Timeline

2001 -- Former dental surgeon Michael Mastromarino of Fort Lee teams up with embalmer Joseph Nicelli in a tissue-harvesting business.

Early 2002 -- The pair allegedly begin more than three years of harvesting tissue without consent.

November 2004 -- Following a complaint, an NYPD detective begins investigating a Brooklyn funeral home that Nicelli had recently sold.

Oct. 7, 2005 -- News of the investigation breaks.

Oct. 13, 2005 -- The Food and Drug Administration orders a recall of any unused tissue procured by BioMedical Tissue Services.

November 2005 -- Medtronic revported that it received approximately 13,000 allografts from Regeneration Technologies, Inc that originated from BioMedical Tissue Services and implanted 8,000 of them.

Feb. 3, 2006 -- The FDA shuts down BTS.

Feb. 23, 2006 -- A 122-count indictment is unsealed in Brooklyn against Mastromarino, Nicelli and two others

March 8, 2006 -- Brooklyn authorities are preparing indictments against funeral home employees, a law enforcement source tells The Record.

Legal Help For Victims Affected By Untested Body Parts Scandal

If you or a loved one has received any bone, organ, or tissue transplant, please fill out the form at the right for a free case evaluation from a qualified defective medical device attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).

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