Parts from fifty-six human corpses were improperly fed into the international tissue market from a state-run Ukrainian morgue, according to prosecutors who have filed criminal charges against five of the morgue’s employees.
The Ivano-Frankovsk regional morgue in western Ukraine was, until recently, authorized by the U.S. Food and Drug Administration to supply the raw material used to make specialized implants for U.S. hospital patients.
Prosecutors filed charges last week against the morgue’s deputy director, three coroners and a nurse alleging they deceived families into signing consent forms and that they did not get proper permission before tissue was obtained from corpses.
Prosecutors said the tissue was sent to Tutogen, a German subsidiary of Florida-based RTI Biologics, the world’s largest for-profit tissue processor.
Tutogen would not have been aware how the tissue was gathered because it was accompanied by all the proper paperwork, prosecutors said.
The case is the latest in a string of criminal probes in which authorities have investigated whether Ukrainian morgue officials took tissue without proper consent.
The defendants face up to seven years in prison if found guilty, prosecutors said.
The charges involve 56 cadavers brought in for autopsy between 2007 and 2011.
These latest criminal charges in Ukraine follow an investigation published in July by the International Consortium of Investigative Journalists.
The ICIJ probe revealed legal, ethical and medical concerns surrounding the growing for-profit human tissue industry.
Families told ICIJ that their loved ones’ cadavers were harvested without informed consent.
One of the main players identified by ICIJ was BioImplant, a Kiev-based company run by the Ukraine Ministry of Health.
BioImplant collected tissue from two-dozen Ukraine morgues to supply Tutogen and its American parent company, RTI Biologics.
RTI has since voluntarily suspended its relationship with BioImplant.
Ukrainian prosecutor Dmytro Verbytsky told ICIJ reporters that BioImplant was paying officials in Ivano-Frankovsk UAH 2000 to 4000 per body, or about $250 to $500 under current exchange rates.
“In some cases, they obtained permission to take two to three fragments from a body, while in fact they took 60 fragments. In exchange, they promised quick and free-of-charge autopsy, dressing and washing the body,” he alleged.
Verbytsky said his office is investigating whether officials at BioImplant were operating an illegal tissue recovery ring.
None of the five charged workers could be reached for comment but Oleksandr Mudrytsky, the director at Ivano-Frankovsk, said his staff did nothing wrong. He said they were not required to tell families how much tissue they planned to take.
“We are not required by the law to explain to the relatives what quantities of tissues are to be taken from a body. If we do tell them what’s on the consent form, they might faint,” he said.
The FDA said it was “monitoring” the Ukrainian probe but added that no health problems have been detected in connection with the material that prosecutors have alleged was obtained illegally. The agency said it was not concerned that imported tissue posed a safety risk to U.S. patients.
“FDA regulations do not address ‘consent’ directly, leaving the regulation of consent of anatomical gifts to state and local authorities,” said FDA spokesperson Heidi Rebello.
“We do not have any concerns about any tissues that were imported into the United States, as our regulations provide a strong framework for protecting the public against communicable disease transmission.”
RTI declined to respond to specific questions, but referred to a statement issued in September that the company complies with U.S. and foreign law.
Laura Siminoff, whose federally funded studies have examined problems with consent laws for tissue recovery, said she was surprised by the FDA response to the charges in Ukraine.
“It’s not an ethically responsible response for a federal agency,” said Siminoff, chair of Virginia Commonwealth University’s Department of Social and Behavioral Health.
“To say they have no concern about this [informed consent] is unacceptable. How you get consent for the use of tissue probably reflects on the integrity of the entire organization abroad.”
After the ICIJ series appeared, Interpol Secretary General Ron Noble said his agency intended to look into the matter.
Since then, the Pentagon has changed one of its policies on tissue procurement, and Congressional investigators are looking into whether U.S. veterans’ hospitals received tissue obtained via improper methods.
The case in Ivano-Frankovsk is one of five cases in which questions have been raised about whether Ukrainian morgues that supplied tissue to the international market were taking tissue without consent.
Three have been dismissed without convictions and nobody has been convicted of any wrongdoing.
The other current investigation relates to four employees working for two morgues in Chernigov, two hours north of Kiev near the Belarus border. Those employees are suspected of illegally obtaining tissue from 159 corpses.
