94 who got stolen body parts told to get tested
Grafts of human tissue may be diseased


The Atlanta Journal-Constitution
Published on: 04/23/06

WASHINGTON — Nearly 100 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, among thousands in a growing nationwide horror story, have been advised to undergo testing for HIV/AIDS, syphilis and hepatitis B and C because the material grafted into them was not properly screened for the infections. Their surgeries took place at Piedmont Hospital, Northside Hospital, Emory University Medical Center, Crawford Long Hospital, Gwinnett Medical Center and DeKalb Medical Center.

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FACTS ABOUT GRAFTS

Grafts of human tissue have saved the lives of thousands of people and made it possible for millions more to recover from chronic conditions, according to Robert Rigney, head of the American Association of Tissue Banks.
Each year in the U.S.:
* Nearly 2 million tissue grafts are performed. Skin, bone, tendon, arteries, veins and other tissue is recovered from the bodies of 25,000 donors. These include 3,500 heart valves, 1,500 vein and artery grafts, and 1.5 million muscoskeletal grafts of bone and tendon.
* More than 19,000 square feet of human skin is retrieved, primarily for burn victims.
* More than 550,000 corneal eye transplants have been performed since 1961.
Unlike human organs, which are retrieved and allocated to recipients under a national network regulated by the federal Health Resources and Services Administration, tissue grafts are regulated by the Food and Drug Administration.

"This ghastly conduct has sent a ripple of fear to anyone who has had a medical implant," said New York City Department of Investigations Commissioner Rose Gill O'Hearn, whose detectives uncovered the scheme last October in which more than 1,000 corpses were allegedly looted in funeral homes for parts that were sold into the legitimate and highly lucrative human tissue market.

The U.S. Food and Drug Administration says that it and the federal Centers for Disease Control and Prevention believe the risk for infection is low. Even so, the FDA recommends that hospitals and physicians who engrafted the suspect material contact patients around the country and advise them of the need to be tested. The FDA has also ordered the recall of bone, tendon, skin, heart valves and other tissues — known as "allografts" — distributed by the company at the heart of the alleged multimillion-dollar scheme, Biomedical Tissue Services of Fort Lee, N.J.

When body parts such as heart valves, skin, bone, tendons and cartilage are legally taken from corpses, FDA rules require permission from the donor or relatives. Proper screening and paperwork should block the harvesting of body parts from unsuitable donors, such as those who were diseased or drug users. In the case of Biomedical Tissue Services, prosecutors allege that bodies were looted — with funeral homes' permission — without regard for disease or cause of death and without donors' or their relatives' knowledge or consent.

One saving grace in the sordid case may be that the stolen parts did undergo routine safety procedures after they were sold for processing and implantation. Strict processing rules require that each product be treated with anti-viral and anti-bacterial drugs and subjected to intense radiation before it is surgically implanted, according to the American Association of Tissue Banks.

"The only good news about this whole episode is the fact that before any of the tissue could be implanted into a human patient, it had to go through one of our laboratories," said Robert Rigney, head of the trade group.

Class-action suits filed

That confidence is apparently lost on trial lawyers.

Class-action lawsuits filed in federal courts in several cities suggest the material spread far from the funeral homes in New York, New Jersey and Pennsylvania where indictments allege it was harvested. By last week, at least 33 federal suits had been filed around the country and an unknown number of lawsuits had been filed in state courts. In the rush to participate in what could be a mammoth class-action lawsuit, some lawyers have advertised on Google seeking clients. Some firms report having hundreds of plaintiffs.

Most of the cases have been filed on behalf of patients who complain of suffering "mental anguish" and the pain of worrying that they may develop disease. At least one plaintiff said she has contracted syphilis and another said tests showed "evidence of exposure to hepatitis B and hepatitis C.

In suits filed this month, a Shelby County, Ala., woman said she received suspect bone during lumbar spinal surgery in Birmingham last year following a car accident. A West Virginia woman and a Pennsylvania man said in separate suits that they received suspect tissue during emergency hernia surgery — performed on both patients on Jan. 1, 2005 — at a hospital in Knoxville.

Another set of lawsuits has been filed by survivors of those whose bodies were allegedly dissected without consent. One such suit alleged that a New York woman whose corpse was dissected had several diseases, including antibiotic-resistant staphylococcus.

At the center of the criminal and civil cases is the head of Biomedical Tissue Services, Michael Mastromarino, a former New Jersey dental surgeon whose cocaine use cost him his license. He and three associates were indicted in February in connection with the macabre enterprise. In addition to obtaining the parts without consent, they allegedly forged documents designed to keep diseased tissues from entering the worldwide tissues market.

Prosecutors say the legitimate laboratories that processed the tissues — none of them related to Mastromarino or his enterprise — include a Kennesaw nonprofit, Lost Mountain Tissue Bank; LifeCell Corp. of Branchburg, N.J.; Regeneration Technologies and Tutogen Medical Inc., both of Alachua, Fla.; and the Blood and Tissue Center of Central Texas in Austin. All are defendants in the growing list of lawsuits.

The tissue processors received and distributed the body parts nationwide, likely without knowing any of the tissues had not been properly obtained, screened or tested. Brooklyn, N.Y., prosecutors examined records of the five companies, none of which was implicated in the indictments as participants in the alleged scheme.

Lost Mountain Chief Executive James D. Wade would not comment for this article. Earlier, he told The Associated Press that his company processed several thousand pieces of human tissue obtained from Biomedical Tissue Services, but distributed only a few hundred, of which fewer than two dozen were transplanted into people.

The company has reported to the FDA that the hospitals to which it distributed the material are located "nationwide and Turkey."

Lost Mountain, which is among the defendants in a number of lawsuits, knows of two Georgia patients who "may have received implants of tissue that was subject to the recall," according to company lawyer Martin M. Wilson of Atlanta. Both patients "have been contacted and neither has reported any problems whatsoever," Wilson said in a written statement. He added that a "minuscule number of tissue allografts" that were recalled have not been returned to Lost Mountain.

Wilson said he believed Lost Mountain was being sued because its name was on the FDA recall notification list. "We have yet to identify any plaintiff who has received tissue with which LMTB was even remotely involved," the attorney said.

Lost Mountain has a previous FDA history of tissue-handling concerns, which the agency says have since been corrected. In 2003, FDA warned Lost Mountain that it was failing to "prepare, validate, and follow written procedures for prevention of infectious disease contamination or cross-contamination by tissue during processing." At the time, the FDA said the Kennesaw firm "routinely reworks tissue products in order to extend the expiration date" without valid written procedures.

Area hospitals notify 94

The Atlanta-area hospitals involved, in response to inquiries, say 94 patients have been told they should be tested because grafts they received involved scavenged body parts. Piedmont has notified 41 patients, Northside 29, Emory University Medical Center (including Crawford Long Hospital) 10, Gwinnett Medical Center nine and DeKalb Medical Center five.

Grady Memorial Hospital, Atlanta Medical Center, St. Joseph's Hospital and the three Cobb County hospitals managed by Wellstar Health System say none of their patients received any of the improperly harvested material.

At Gwinnett Medical Center, spokeswoman Paula Martin said identifying the nine patients who received bone grafts from the FDA recall material "was somewhat labor intensive" because officials had to study patient charts.

"We notified the patients directly," she said. "If it happened in our hospital, we took that responsibility, rather than go through the doctors."

Martin said the nine bone grafts could be traced to Regeneration Technologies, which acquired the material from Biomedical Tissue Services. All the material had been subjected to a process called "biocleansing" before it was engrafted and none of the patients has had any problems, she added.

Most of the Atlanta-area hospitals in which patients received Biomedical Tissue Services parts could not say this week which processors provided them with the finished product.

Spokesmen for Northside and Piedmont said confidentiality clauses in their procurement contracts prevented disclosure of suppliers' names. A DeKalb Medical Center spokeswoman said she could not obtain names of suppliers. An Emory-Crawford Long spokesman cited a policy against discussing relationships with vendors.

Potential for thousands

The potential impact of the implant nightmare is vast.

By October, when the FDA told surgeons to notify their patients to be tested, 1,974 tissue providers registered with the FDA from around the globe listed Biomedical Tissue Services as a source.

There is no central record of how much of the stolen material was engrafted into human beings but one processor listed more than 5,000 individual grafts that it said had been distributed in New Jersey, Florida, Alabama, Texas and Georgia. One bone can be cut and refigured into many pieces, often to specifically ordered sizes and shapes, for implantation.

Court records filed by Cleveland lawyer Jack Landskroner on behalf of a woman who received a spinal implant of suspect tissue show the FDA has a list of about 13,000 "lot numbers" of improperly harvested tissue that was sold to processors.

Each number may represent several different grafts, and lawsuits filed in both state and federal courts allege that "tens of thousands" of persons could have been exposed to the questionable material.

Health Canada, the country's national health department, has said that about 300 grafts from the illegal New York collections were used there.

A spokeswoman for Motley Rice LLC of Charleston, S.C., one of the country's largest plaintiff litigation law firms, said the firm had lined up 283 "potential" clients from several states.

In Pensacola, Fla., attorney Marcus Michles said he had about 20 clients, all from the Florida panhandle.

Michles also said that "a block of Pensacola doctors" have declined to notify patients that they received questionable grafts and implants, reasoning that the risk was too low to justify the stress that notification would cause the patients.

Regulation questioned

It is not clear from records how any of the tissue brokers could have known that the material from New York was illegally harvested or mislabeled. Many lawsuits, however, accuse processors of recklessly failing to exercise proper diligence.

Atlanta lawyer Don C. Keenan, who was involved in a widely publicized series of suits against companies in the human tissue market two years ago, said the industry is poorly regulated — in contrast to the system in which body organs such as hearts and kidneys are recovered and preserved for transplant.

"Anybody with a chain saw and a truck can go into this business," Keenan added.

But Rigney, of the American Association of Tissue Banks, disputes that, saying the industry has been heavily regulated since 1993. His organization is working to develop additional procedures to detect falsified documents and prevent recurrence of the New York fiasco.

"We want to protect against this ever happening again," Rigney said. "In the 30-year history of our organization, we've never seen something like this before."

He said Biomedical Tissue Services was not certified by his organization.

In response to written questions, FDA spokeswoman Julie Zawisza confirmed that the tissue retrieval operation had passed FDA safety inspections before the allegedly fraudulent recovery operation came to light.

"The agency had no reason to suspect that the donor eligibility determinations were not performed according to FDA requirements," she added. "FDA's more recent inspection of Biomedical Tissue Services [last October] identified deviations that, because of their serious nature, constituted a danger to public health."

It was then that the FDA ordered Biomedical Tissue Services to cease its shipments.

Comparing the alleged enterprise to "something out of a cheap horror movie," Kings County, N.Y., District Attorney Charles Hynes announced the 122-count indictments Feb. 23 in Brooklyn.

Mastromarino and the others harvested parts in a secret room of a New York funeral home, replacing bones with plastic pipe and repairing incisions so that the dissections would not be noticed at funerals, the indictments allege.

In some cases, cause of death or age of the person at death were reportedly altered on paperwork to make the stolen material appear to comply with FDA regulations.

Staff writer Alison Young contributed to this article.

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