Bogus records raise more fears in tissue trade
Probe finds trail of mistakes, fabrications about death of TV personalitySep 18, 2006 | AP
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.