U.S. transplant patients file lawsuits in stolen body parts caseApr 29, 2006 | AP
At least a dozen people who had routine operations said they caught deadly viruses and other germs from body parts stolen from corpses in a ghoulish scandal that has sent hundreds of people for tests.
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.