Recently publicised cases in the United States relating to shady organ procurement processes – and cases of still-living, neurologically active patients almost having their organs harvested, amid a desperate shortage of available organ donations – have shamed the industry and triggered widespread federal investigations.
Last Thursday, Health and Human Services Secretary Robert F Kennedy Jr said steps were being taken to shut down an organ procurement organisation in Miami with “a long record of deficiencies directly tied to patient harm”.
Officials said the move was a warning that they are scrutinising the nation’s 55 non-profit organ procurement groups, each of which has a government-granted regional monopoly for procuring organs from donors and transferring them to transplant centres, The Washington Post reports.
For years, the groups have been the target of an array of complaints involving financial fraud, favouritism and, in some instances, inadvertent attempts to harvest organs from patients who were not yet deceased.
Lived to tell the tale
Six years ago Larry Black Jr, who had been shot in the head, was being prepped to have his organs harvested when a last-minute intervention in the operating room – by his neurosurgeon – stopped the procedure, reports KFF News
Today, the musician and father of three, can walk and talk.
In 2019, lying on an operating room table with his chest exposed, he was within minutes of having his organs removed when a doctor ran into the room.
“Get him off the table,” the doctor recalled telling the surgical team at SSM Health Saint Louis University Hospital as the team cleaned Black’s chest and abdomen.
At first, no one recognised Zohny Zohny in his surgical mask. Then he told them he was the neurosurgeon assigned to Black’s case.
Zohny said the team members pushed back, protesting that they had the family’s consent to remove Black’s organs.
“I don’t care,” Zohny recalled telling them. “I haven’t spoken to the family, and I don’t agree with this. Get him off the table.”
Black (22), had arrived at the hospital after getting shot in the head on 24 March 2019. Just a week later, he was taken to surgery to have his organs removed for donation – even though his heart was beating and he hadn’t been declared brain-dead, Zohny said.
Black’s sister Molly Watts said the family had doubts after agreeing to donate Black’s organs but felt unheard until the 34-year-old doctor, in his first year as a neurosurgeon, intervened.
Today, Black said he had tried to show everyone in his hospital room that he heard them. He recalled knocking on the side of the bed, blinking his eyes, trying to show he was fighting for his life.
Lifesaving procedures
Organ transplants save a growing number of lives in the US every year, with more than 48 000 transplants performed in 2024, according to the Organ Procurement and Transplantation Network, which oversees the nation’s transplant system.
But organ donation has also faced ongoing criticism, including reports of patients showing alertness before planned organ harvesting.
The results of a federal investigation into a Kentucky organ donation non-profit, first disclosed by The New York Times in June, found that during a four-year period, medical providers had planned to harvest the organs of 73 patients despite signs of neurological activity.
Those procedures ultimately didn’t take place, but officials vowed in July to overhaul the nation’s organ donation system.
“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” Kennedy had said in a statement.
“The system must be fixed to ensure every potential donor’s life is treated with the sanctity it deserves.”
As far back as 2020, a congressional oversight committee cited reports of gross mismanagement, lapses in quality control and financial impropriety.
Announcing the decision to remove the Miami organisation from the transplant system, Kennedy and other officials said it was long overdue.
The Miami group – Life Alliance Organ Recovery Agency, a division of the University of Miami Health System – said it would not appeal the decision.
Officials said an investigation had uncovered “years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors”.
Allegations unfolding for years
In December 2020, the congressional committee had sent a letter to the group asking for more information and noting that there were already a number of reported failures: it had sent a uterus to a transplant centre without alerting the centre that the donor had a bladder infection, causing the attempted uterine transplant to fail; its staff left a pancreas sitting on a counter for nearly two hours; and a former administrator allegedly assaulted a registered nurse and former medical director.
In June 2024, its executive director Alghidak Salama issued a resignation letter saying that group was “woefully understaffed” and that “the fraudulent practices that I found and reported last year remain unabated”.
In a statement he sent to HHS staff five months later, he was scathing and more detailed.
“I first want to be clear that I believe the organ procurement industry is full of fraudsters and career criminals, and patients will never be safe and protected until these people are held accountable,” Alghidak wrote.
He also cited instances of padded bills and salaries.
“One member of the surgical team billed for the equivalent of 2 099 hours in the span of four months, which is physically impossible,” he wrote.
The primary source of income for the organ procurement groups is Medicare, which under a 1972 law pays 100% of the costs of harvesting and transplanting kidneys. They also receive money through insurers.
Little understood
Even before this latest investigation, Black’s case showed neurosurgeon Zohny that the organ donation system needed to improve. He said his patient’s story had stuck with him for years, highlighting that while organ donation must continue, little is understood about human consciousness.
And determining when someone is dead is the critical but confusing question at play.
“There was no bad guy in this. There’s a problem in the system,” he said. “We need to look at the policies and make some adjustments … to make sure we’re doing organ donation for the right person at the right time in the right place, with the right specialists involved.”
“In every case, the patient must be declared legally dead by the hospital’s medical team before organ procurement begins. This is not negotiable,” Mid-America Transplant’s CEO and president, Kevin Lee, wrote in a post on the non-profit’s website, after the news about the investigation in Kentucky.
He said a person can be pronounced dead in two ways: if their heart stops beating and they stop breathing, which is when donation after cardiac death can occur. A person can also become an organ donor if their brain, including the brain stem, has irreversibly ceased functioning, which is when brain death donation can occur.
“Every hospital has its own process in declaring both types of death,” Speir said in a statement. “Mid-America Transplant ensures hospitals follow their policies.”
After Zohny’s intervention, Black was wheeled back to the ICU. The medical team held back all medications that caused his sedation, and two days later, the patient woke up and started speaking.
Within a week, he was standing.
Zohny, who was working as a fellow and assistant professor at the time, left the Saint Louis University Hospital job later that year when his fellowship ended. He said Black’s story made him question what we know about consciousness.
He’s now working on a new method that quantifies consciousness, which he said could possibly be used to help measure consciousness from brain signals, like with an electroencephalogram, or EEG
He said his method still needs rigorous validation, so he recently started a medical research company called Zeta Analytica, separate from his work at the West Virginia University Rockefeller Neuroscience Institute, which he’ll begin in October.
“We don’t understand the brain to the level that we should, especially with all of the technology we have now,” Zohny said.
See more from MedicalBrief archives:
‘Brain dead’ US man awakens during organ harvesting
Experts differ on when to declare a patient dead
Patients’ alertness ignored in quest to harvest organs, finds US probe