James Eason, MD, who earned acclaim by operating on Steve Jobs, led the transplant center named in his honor at Methodist University Hospital in Memphis. An internal analysis by Eason's own team details the preventable deaths under his watch.

This article was published on Wednesday, June 14, 2023 in ProPublica.

By Max Blau, ProPublica

On a brisk morning in the winter of 2019, at a standing-room-only reception, a procession of speakers lavished praise on the surgeon who more than tripled the size of the liver transplant program at Methodist University Hospital in Memphis. The lifesaving doctor was receiving an honor often reserved for the dead: Methodist's leaders announced that the hospital's new state-of-the-art transplant center would be named for Dr. James Eason.

Eason seemed to have reached the summit of what was then a 25-year career. A decade earlier, he had performed one of the highest-profile liver surgeries in recent history: the transplant that extended the life of Apple co-founder Steve Jobs by more than two years. That operation earned Eason the gratitude of Jobs' widow, who later donated a total of $40 million to the transplant center he helmed and the medical school where he worked as a professor. At age 58, Eason had become one of the country's highest-paid transplant surgeons, earning $1.7 million a year, more than anyone at Methodist but the head of its nearly 13,000-employee, six-hospital health system.

But for all the lives the liver transplant program saved, the hospital's leadership had growing concerns about the number of patients dying on Eason's watch. During the five years before the renaming ceremony, those deaths had sparked investigations from the federal contractor that oversees transplant centers. They also prompted multiple health insurers to remove the liver program from their preferred networks, according to internal documents.

In 2018, following the most recent investigation, Methodist hired a consulting firm to audit the program. The audit, conducted by peers from other transplant centers, found that numerous errors had contributed to patient deaths — and that to reduce the rate of failed liver transplants, Methodist likely would have to perform fewer transplants overall. But according to the audit, that would be difficult. Staffers felt "powerless to make change due to the resistance of leadership," who gave the employees the impression that "volume is king," the audit said.

The audit concluded that "disruptive, disrespectful, non-collaborative individuals" had put the liver transplant program and its patients "in a constant state of risk."

In December 2018, Methodist University Hospital President Roland Cruickshank wrote a letter to the federal contractor acknowledging the transplant program's worrisome number of deaths. "The decline in our outcomes is of the utmost concern," he wrote, "and is not taken lightly." Weeks later, Cruickshank sat in the front row of the renaming ceremony and stepped up to unfurl a banner with the words "James D. Eason Transplant Institute."

ProPublica and MLK50: Justice Through Journalism obtained an extraordinary cache of internal records that reveal Methodist leaders failed to comprehensively fix problems with the liver program before the renaming ceremony. The records include the independent audit, detailed internal reviews of patient deaths and the hospital's correspondence with the federal contractor, a nonprofit called the United Network for Organ Sharing, or UNOS.

One of the documents was an internal analysis drafted at Eason's behest. In part of the analysis, one of his most senior colleagues determined that between late 2014 and mid 2018, 25 deaths — more than half of the program's 48 total fatalities — were preventable.

The analysis found that some liver recipients had died after their transplant as a result of "process/protocol issues." It also found that a portion of patients "should not have been listed" for transplant due to preexisting medical conditions.

Along with the documents, interviews with families of nearly two dozen liver transplant recipients who died over the past decade show that, in some cases, Methodist staffers didn't tell them about the extent of the problems that contributed to their loved ones' deaths.

Terry Green, a retired Army noncommissioned officer who donated a portion of his liver to his identical twin brother, did not know that Eason's team had, according to medical records and internal documents, failed to conduct enough testing to rule out the risks of cardiac and pulmonary complications before Eason himself performed the transplant. His brother died from cardiac arrest in the operating room.

Stacy Roberts was unaware that, following her father's transplant, Eason's team had identified major problems with the donated liver it had placed inside him, issues it may have been able to identify with further screening, internal records show. Methodist had accepted the liver from another hospital, which had failed to spot that the organ bore the early signs of cirrhosis. Days later, after her father experienced serious complications, Methodist providers conducted their own biopsy, discovering the full extent of the damage to the organ. Her father died about a month after the surgery. Hospital records show that transplant program leaders later required surgeons to more rigorously review liver donations before accepting those organs for patients.

For years, Tiffany Garrigus was haunted by the memory of watching her 59-year-old father die just several hours after his transplant. Unbeknownst to Garrigus, a nurse had reported concerns about internal bleeding to the surgical fellow on shift and noted that the doctor failed to quickly alert the attending surgeon. The miscommunication delayed potentially lifesaving care. The independent auditors later determined that Methodist's own review of Steve Garrigus' death was a "missed opportunity" to prevent similar issues in the future.

"They screwed up," Garrigus said after she learned about records that outlined Methodist's treatment of her father. "No one was held accountable and nothing changed."

Garrigus and five other families who spoke with ProPublica and MLK50 signed documents waiving their rights to privacy so Eason and Methodist could answer questions about their loved ones' deaths. Eason and Methodist declined to address those questions. The hospital and Eason also did not answer specific questions about the dozens of deaths detailed in the investigations, the findings in the audit of the transplant program or the correspondence between the hospital and UNOS.

Spokespeople for Eason and the hospital asserted that ProPublica and MLK50 singled out patients with negative outcomes. Methodist spokesperson Tabrina Davis also said in a statement that the news organizations had "settled on a clear narrative, one which we believe is a misleading and inaccurate portrayal of the institute." The statement went on to say that "the transplant institute is on a continuous journey of improvement, focused on providing the highest quality care for each patient."

Eason turned down multiple requests to be interviewed for this story but responded to questions in writing at various points. In one statement, he said that he and his team at Methodist "tried to give every patient the opportunity for transplant." He also said in that statement that while there were "2-3 unexpected deaths per year" between 2011 and 2018, "we also saved more than 100 lives each year, all of whom would have died without liver transplantation." Eason's lawyer, Elizabeth Sacksteder, said in a separate letter that "performing more transplants rather than fewer" and using "the best available organs rather than waiting for the perfect organ" are pivotal parts of Eason's approach to running a liver transplant program.

For more than a decade, Methodist liver recipients had a greater-than-expected chance that their liver would not be functioning one year after transplant, a metric used by UNOS to assess transplant centers' performance. Eason said in his statement that UNOS had overrelied on that metric without taking into account that programs like Methodist have accepted more high-risk patients who would otherwise die imminently. He added that Methodist has excelled at minimizing the extent to which patients die on the waitlist, a metric that is now part of how UNOS evaluates transplant programs.

"I would never choose to let a single high-risk patient die instead of giving that individual a good chance of living," Eason said in another statement.

Eason, however, is no longer making those choices at Methodist. This past August — after years of investigations and years of Methodist leaders celebrating Eason's accomplishments — hospital employees were unexpectedly pulled into a conference room at the transplant center. Standing at the front of the room, along with other top executives, was the head of the health system. He shared a brief message that caught employees off guard: Eason was no longer with the James D. Eason Transplant Institute.

Methodist's Liver Transplant Outcomes Drew Scrutiny From Investigators

The United Network for Organ Sharing launched two investigations over the past decade after Methodist University Hospital's liver transplant program performed worse than expected.

Transplant centers report data about their performance to UNOS, which examines whether the performance of transplant programs was worse than expected. To do so, UNOS analyzes the extent to which transplanted livers still functioned one year after a surgery.

Each percentage is based on outcomes over the prior 30-month period. For still-functioning transplants performed in the last six months of the study period, the chance of a liver continuing to function one year after the surgery is modeled after the outcomes of previous transplants in the study period.

The blue line shows the percentage of Methodist patients expected to have a functioning transplanted liver at one year, based on characteristics of the liver transplant program's prior recipients and donors. The yellow and gray lines show the chance of a patient having a functioning transplanted liver at one year, modeled after real-world outcomes.

Before his arrival at Methodist, Eason led another transplant center that was investigated for its poor performance during his tenure.

In the winter of 1998, Eason left his post as head of a San Antonio military hospital's transplant center to begin a new job. He now oversaw liver and kidney transplants at the Ochsner Foundation Hospital just outside New Orleans. Eason's team increased the number of liver transplants Ochsner performed from 23 in 1998 to 76 in 2001. But the rapid growth was followed by higher rates of deaths within a year of transplant, according to data from the Scientific Registry of Transplant Recipients.

One of Eason's colleagues, Dr. Ari Cohen, subsequently wrote in a presentation to a group of transplant experts that the rate of adult patients living for one year after their liver transplants at Ochsner became "significantly worse than expected" between July 2002 and December 2004.

In 2005, a UNOS committee began investigating the reasons behind poor outcomes at Ochsner, according to an article written by Ochsner doctors that was later published in the health system's academic journal. The article described the liver transplant program's culture prior to 2005 in a way that was similar to what Methodist's audit would turn up years later: A "feeling of fear" had left employees "unable to freely express their views" about the program's problems.

In response to the UNOS investigation, Ochsner put together a team that determined the transplant center's leadership was one of the biggest problems contributing to the liver program's poor patient outcomes.

UNOS spokesperson Anne Paschke said that the organization does not comment on specific investigations. Cohen, along with other Ochsner doctors who contributed to the article, did not respond to emails or phone calls. An Ochsner spokesperson declined to respond to ProPublica and MLK50's questions or make anyone available for an interview. Eason declined to comment on the UNOS investigation or his former colleagues' reflections on the program under his leadership. In his statement, he said that he came to Ochsner after the program had been "closed due to loss of leadership" and that the program "went from saving zero lives to saving more than 80 lives each year."

Before the UNOS committee completed its investigation, Eason accepted an offer that would allow him to return to his home state of Tennessee — and provide an opportunity to take another small liver transplant program and grow it even more dramatically.

In the five years following Eason's departure, his former colleagues addressed the problems, according to the journal article. They turned Ochsner's liver program into one of the top performers in the South, according to healthcare ratings organizations.

When Methodist announced Eason's hiring in 2006, Dr. Hosein Shokouh-Amiri was deeply concerned. The veteran Methodist surgeon said he had heard about the rapid expansion of Ochsner's transplant program and was worried that a similar approach might lead to higher rates of failed liver transplants for Methodist patients.

Amiri was afraid that Eason would override clinical decisions that Amiri or his colleagues had determined were in the best interest of patients. And so he decided to leave the transplant program shortly after Eason arrived. Before Amiri's final day at Methodist, Eason wanted to know if he would reconsider. Sitting in Eason's office, Amiri asked if Eason would ever require a surgeon to accept a donated liver that the surgeon would rather decline because of poor quality. Amiri recalled that Eason wouldn't answer at first. Amiri said that when he pressed for an answer, Eason told him that he would do so if he felt it was necessary.

As Amiri saw it, Eason's track record of boosting volume would "bypass the moral and ethical standard we had promised" to Methodist patients.

"He wanted my approval," Amiri said. "I resigned."

Eason did not respond to questions about Amiri's recollections and concerns. Eason's spokesperson, Stefan Friedman, wrote in an email that Amiri left Methodist "to go to a program that performed only 11 transplants last year with higher deaths on the waitlist and lower one-year survival rates." Amiri said that his liver transplant program had lower survival rates "because we took sicker patients." Federal health data confirms that Amiri's program accepted a higher percentage of patients at high risk of death from liver disease than Methodist.

During his early years in Memphis, Eason led the dramatic growth of Methodist's liver transplant program. The year before he started, in 2005, Amiri and his colleagues had performed 34 liver transplants. Over the next three years, Eason's team more than tripled the hospital's annual number of liver transplants, replacing 117 organs in 2008. Methodist leaders celebrated this growth as a historic achievement — one that allowed the liver transplant program to serve more patients in a majority Black city that had a higher poverty rate than the national average. Eason's lawyer said in a letter that the population of the Memphis region "disproportionately suffers from co-morbidities associated with poverty" that "heighten the inherent risks of liver transplant surgery."

By performing 126 transplants in 2009, Methodist became one of America's 10 largest liver transplant programs. As hospitals across the country expanded their transplant centers, they stood to profit from treating more patients suffering organ failure. According to a 2009 study published in Medical Care Research and Review, the average cost of a U.S. liver transplant and the subsequent days spent recovering in the hospital was about $163,000. Around that time, The Wall Street Journal reported that some hospitals charged nearly three times as much for the surgery. Friedman said in a statement that Eason did not receive additional compensation for performing more transplants, "nor was any aspect of his compensation based on such a metric." Methodist did not respond to questions about the program's finances.

The growth of Methodist's program was fueled in part by a special agreement with federal health officials that allowed the program to obtain livers across the entire state of Tennessee and parts of Arkansas and Mississippi. As the program grew, it began attracting more patients from beyond the greater Memphis area. A central Ohio minister received a liver transplant at Methodist in 2009 after being rejected by three other programs. He lived for another 12 years. A mechanic from San Juan, Puerto Rico, who experienced liver failure received a transplant at Methodist in 2010; in an interview translated by his wife, Carlos Acevedo Martinez told ProPublica and MLK50 that he had no complications and was grateful "Methodist gave him life again."

Near the end of his third year at Methodist, Eason was in touch with his friend George Riley, a Memphis native whose parents had been doctors at Methodist. Riley, a California lawyer, wanted to know if Eason might help his client. Steve Jobs faced a long wait to get a new liver in his home state of California. His wife, Laurene Powell Jobs, had learned that people could be simultaneously added to waitlists in multiple states. Since Jobs had a plane, he could fly to whichever transplant center was willing to accept him. Tennessee, it turned out, had a shorter waitlist.

One day in March 2009, before dawn, Eason waited for Jobs' plane at the Memphis airport. "I went to meet him and escorted him to the hospital," Eason later told WMC-TV. One of Jobs' biographers, Walter Isaacson, wrote that Eason closely oversaw Jobs' care after the transplant, assigned nurses solely to his recovery and "would even stop at the convenience store to get the energy drinks Jobs liked." Jobs later recovered in a 5,784-square-foot mansion in Memphis that Riley purchased through a shell company, according to The Commercial Appeal.

Weeks after Jobs returned home that spring, news broke of his surgery. Media outlets including CNN and The New York Times published articles that explored whether Eason gave preferential treatment to the billionaire. The surgeon pushed back: Jobs was the sickest, most deserving patient on the day that liver became available, he said. Starting that summer, Eason lived on and off in the mansion — a perk he didn't publicly disclose at the time. Two years later, in 2011, he bought the house from the shell company for $850,000, the same price the company paid for it in 2009. (Home sale prices in the greater Memphis area had fallen in the interim.) Eason did not respond to questions about living in or buying the home.

Around the time of Jobs' transplant, Methodist's liver recipients had a better estimated chance of their organs functioning at least one year after a transplant than the national average. But in the years after Jobs' surgery, Eason's liver transplant program began to struggle. The rate of failed liver transplants increased between July 2010 and December 2012. As a result, the UNOS committee that had scrutinized Ochsner's performance under Eason opened an investigation in early 2014. The committee's work is confidential, but ProPublica and MLK50 obtained records that described the investigation. (UNOS declined to confirm when the investigation ended.)

The UNOS committee, which is composed of several dozen transplant experts who volunteer to review their peers' programs, can recommend the discipline of transplant centers for their poor performance. But the committee rarely punished programs. In fact, the committee was so toothless that in 2018 the then-CEO of UNOS likened the committee's investigations to "putting your kids' artwork up at home."

"You value it because of how it was created rather than whether it's well done," the UNOS leader wrote of the investigative committee. "Only in this case, we persuade ourselves that it's well done anyway."

Though Eason now defends the program he led, he acknowledged in an April 2014 letter to the UNOS committee that Methodist's outcomes "were not as expected." He pledged to address the committee's concerns.

According to internal documents from June 2014, Methodist was anticipating potential financial fallout from those poor outcomes. A Centers for Medicare & Medicaid Services official had informed Methodist that its liver transplant program was out of compliance with federal standards because it had "significantly lower than expected" outcomes and did not have an adequate policy for evaluating the reasons behind its failed liver transplants. The official warned that CMS would terminate the liver program's participation in Medicare, which covered the costs for nearly a third of the liver transplants performed at Methodist, if it failed to correct those problems.

In its written plan outlining how it would fix the problems, Methodist told CMS that one way it would improve outcomes was through Eason encouraging a "higher scrutiny of patients" whose risks of complications outweighed the potential benefits of surgery. Methodist ultimately avoided termination from Medicare.

But records obtained by ProPublica and MLK50 show that Methodist kept accepting patients whose poor health increased the risk of complications after a transplant. Eason's team soon approved for transplant a 356-pound woman with a BMI of 66 and a woman who struggled so much with drinking alcohol that she only stopped after getting sick from liver failure. The team also signed off on a patient for transplant in spite of the fact that she was septic the day before the surgery. All three died within a year after their transplants.

Dr. Satheesh Nair, one of Eason's most senior colleagues, later determined in an analysis of patient deaths that Methodist should not have placed these patients on the transplant waitlist. Nair did not respond to questions. Eason did not comment on the findings of the analysis, but said that he asked for it to be done as part of his transplant program's efforts to improve its quality of care.

Davis, the Methodist spokesperson, also declined to comment on Nair's findings. She said in a statement that Methodist has turned away liver transplant candidates because they "do not meet the criteria to indicate they would have successful outcomes" after a transplant.

By the time Jerry Green arrived at Methodist in 2016, the 46-year-old minister from West Memphis, Arkansas, was experiencing symptoms of liver failure, including fatigue and jaundice. As Green underwent a battery of tests, the evaluation revealed potential signs of pulmonary hypertension, according to hospital records. That condition can increase the risk of death from a transplant.

Medical experts have written in journal articles that when a transplant candidate has signs of pulmonary hypertension, additional testing, including what's known as a right heart catheterization, should be done to more precisely determine the risk of complications during or after a transplant. If the risk is too great, liver transplant programs can either reject the patient or postpone the surgery until the patient receives care to improve their health. But "no further assessments were made," according to an internal analysis of Green's treatment that the liver transplant program later conducted.

Methodist doctors calculated that Green had a strong chance of surviving for three months without a transplant. But that also meant he was unlikely to get a liver from a deceased donor because he would be low on the waitlist. According to hospital records obtained by ProPublica and MLK50, Eason encouraged Green to get a transplant immediately the only way he could: by finding a living donor. Green was reluctant. But when he gave in, he asked his twin brother, Terry. He agreed.

In the summer of 2016, as the Green family packed inside Methodist to support the twins, a surgeon sliced open Terry's abdomen. It was one of the first living liver donor transplants ever performed at Methodist. Once they started Jerry's surgery, his pulmonary arterial pressure rose so much that surgeons considered halting the transplant. Methodist providers gave Jerry medication that lowered his pressure. According to an operative report from a surgical fellow, Eason "had extensive discussion with his family, where they strongly hoped to undergo the surgery with any possible measures." (Jerry's wife, Jacqueline Green, said that she was notified about the concerns over his pressure but did not have an in-depth discussion with Eason about the risks of proceeding with the surgery.) Eventually, surgeons began replacing his liver with a segment of Terry's.

Once Terry woke up, Eason stopped by to check on his abdomen. The surgeon then shared the worst news of Terry's life. Jerry's heart had suddenly stopped. The staff tried to revive him in the operating room but could not pull him back from the brink of death. "His heart wasn't strong enough," Terry remembers Eason saying. "What we learned here will help others in the future."

After the funeral, Jacqueline met with Eason to learn more about what went wrong. As Jacqueline asked questions about Jerry's death, Eason said that the liver transplant was successful. "It was just his heart" that failed, she recalled Eason saying.

The following year, Methodist enacted several new policies designed to more rigorously test patients' cardiac and pulmonary risks ahead of a liver transplant. In the program's internal analysis, Nair later determined that Green's death was preventable. Jacqueline said Eason never told her about that finding.

Not long after Jerry Green's death, Eason and nearly two dozen colleagues gathered for a confidential meeting. A familiar problem that had dogged the program was now resurfacing.

Four years earlier, in December 2012, CMS had announced it would cut off a crucial part of Methodist's organ supply from central and east Tennessee. Some transplant experts praised the decision because they felt Methodist had unfairly benefited from an old policy that provided access to more high-quality organs from a large geographic area. To avoid shrinking what had become the nation's fourth-largest liver program, Methodist accepted more livers that posed a higher risk of complications for their recipients. Eason's transplant quality director later wrote in a document responding to the UNOS committee's investigation that the strategy was justified as the country faced a chronic organ shortage. As the quality director explained, the additional risk was in "balance against the risk of candidate death on the waitlist."

At the confidential meeting, Eason and his staff focused on a case that exemplified the perils of such risk-taking. That July, Methodist had received a liver offer from a North Carolina hospital. The liver had belonged to a 34-year-old military veteran who had struggled for years with use of hard drugs and alcohol. The way that he died required that his liver be removed after his heartbeat stopped, known as a donation after circulatory death or DCD. Such donations involve an organ that has been deprived of sufficient oxygen between the time of death and the organ's removal. As a result, these donations can elevate the risks of complications for a recipient. That year, about 6% of U.S. liver transplants involved DCD organs, according to data from the Scientific Registry of Transplant Recipients. The data also showed Eason's team accepted DCD livers at a percentage nearly triple the national average.

The night that Methodist received the liver offer, one of Eason's surgeons described the donor's history to Eugene Willard, a 61-year-old grandfather who served as the mayor of his small town of Amagon, Arkansas. Willard wanted to reject the offer, according to his daughter, Stacy Roberts. Two weeks earlier, another Methodist doctor had determined Willard would be a "suitable candidate for liver transplantation providing he loses weight," records show. That doctor had encouraged Willard to slim down to lower his risk of complications whenever the transplant did happen. But with the offer on the table that night, the surgeon urged Willard to accept the liver, his daughter recalled. "If you don't do it, you're going to die," she remembered the surgeon saying. Willard followed the surgeon's advice and agreed to accept the organ.

After Willard's new liver showed signs of poor function, Methodist providers ordered another biopsy to better understand his complications. This time, they saw that the donated liver had so much scarring that the early stages of cirrhosis were present. He died about a month after the surgery.

At the confidential meeting, the team concluded that the North Carolina hospital's biopsy of the donated liver "may have been inadequate." Eason's team responded by approving a policy change that required surgeons to more rigorously examine biopsies before accepting livers. Nair's analysis later determined that Willard's death was preventable, citing "donor selection" issues.

Data from the Scientific Registry of Transplant Recipients shows that Methodist continued to accept DCD livers in 2017 and 2018 at rates higher than twice the national average. Eason's transplant quality director later explained in the response to UNOS that Methodist's surgeons accepted more high-risk livers because they had "access to fewer local organs than the national rate," leaving the program little other choice for saving patient lives. The quality director defended the practice as one that "represents our effort to provide care to an underresourced patient population."

"Most have no other opportunity or hope of transplantation," the quality director wrote.

Over the course of 2018, Methodist's transplant center leaders were confronting a new round of scrutiny. After a period of improved patient outcomes following the UNOS committee's investigation four years earlier, the liver transplant program's failure rate had again worsened. As a result, the UNOS committee opened another investigation.

Methodist responded with a step intended to help its struggling program. It hired the transplant consulting firm Guidry & East to conduct an audit of its liver transplant program's operations.

Five transplant experts — including doctors affiliated with medical schools at the University of California, San Francisco and Cornell University — traveled to Memphis in October 2018 for the two-day audit. They toured the center's halls, interviewed employees and reviewed liver transplant records. The experts wrote a 35-page report, a final draft of which was obtained by ProPublica and MLK50, that identified a list of problems that they said contributed to patient deaths.

The audit stated that Eason's program appeared to "maximize the number of transplants by disregarding flags" as to whether patients were suitable candidates for surgery and, according to one Methodist doctor, was "currently accepting less than ideal donor organs for transplantation." It also determined that the program had failed to thoroughly review the causes of patient deaths in order to prevent repeat mistakes with future patients, a problem previously identified during federal inspections.

To better protect patients, Eason would need to improve its policies in a way that would limit surgeons from operating on patients unlikely to survive long after transplant, in addition to limiting the number of high-risk organs the program accepted, the experts' audit determined.

The experts also flagged problems with the hospital's oversight of its liver transplant program. The audit noted the stark "disconnect" between Eason's team and hospital leadership. "There is a lack of transparency in what is reported," the experts determined.

After the audit, Methodist University Hospital President Cruickshank pledged in a letter to the UNOS committee that senior hospital leadership would "work closely" with Eason's team to adopt Guidry & East's recommendations. Those changes, Cruickshank said, would "once again allow us to meet the UNOS requirements and our own expectations of exceptional outcomes." (Cruickshank, who has since left Methodist, did not respond to multiple requests for comment.)

In February 2019, less than two months after Cruickshank's letter, Eason stood at the renaming ceremony before his supporters, including Laurene Powell Jobs, an internationally known philanthropist who has donated to a wide variety of causes. (Powell Jobs' social impact organization Emerson Collective contributes to numerous media organizations, including ProPublica and MLK50, and owns a majority stake in The Atlantic. Through a spokesperson, Powell Jobs declined to comment about her support of Eason and Methodist.) In the halls of Methodist's new $275 million nine-story tower, a portion of which would be home to the transplant center that had received her donation, Eason and Powell Jobs posed for a photo before a wood-paneled wall lettered with the surgeon's name on it.

Later that month, Methodist received a letter from the chair of the UNOS committee overseeing the investigation, whose members had met to review the Guidry & East audit. The letter stated that "recent outcomes do not seem to be improving."

In April 2019, as Methodist was about to welcome patients to its new transplant center, Eason wrote in a letter to the UNOS committee that the liver transplant program was headed in the right direction. To address the committee's concerns, Eason presented a detailed plan that outlined how Methodist was overhauling policies within its liver transplant program. He attached newly written guidelines that directed the program to be more stringent in accepting high-risk patients and livers. He also noted that transplant leaders were routinely holding conferences where staffers more thoroughly reviewed cases with bad outcomes, openly discussed medical mistakes and identified ways to prevent repeat errors.

"We believe our team has made tremendous progress in improving the outcomes of our Liver Transplant Program," Eason wrote.

Davis, the Methodist spokesperson, said in a statement that Methodist "considered every recommendation" from Guidry & East and enacted some of those policies "right away." Neither Eason nor Nair responded to questions about the Guidry & East report.

After the new transplant center facility opened that spring, the liver program's numbers did, in fact, begin to turn around. The program's rates of failed liver transplants continually improved in 2019 and 2020. But they did not improve enough to clear the threshold that the UNOS committee typically required to close an investigation.

In 2021, UNOS rewrote the rules for investigating transplant programs. Ian Jamieson, then the chair of the investigative committee, said that judging programs on post-transplant outcomes alone had created a "disincentive to transplantation." To remove that barrier, UNOS leaders decided, a program would have to have far worse rates of failed liver transplants before UNOS would automatically step in to investigate.

UNOS touted the policy as "a more holistic approach" to evaluating transplant programs, since the committee would now also consider the extent to which patients were dying on the waitlist. The changes were not universally praised: Critics worried that the policy would lead to fewer transplant programs being held accountable.

Around the time the new UNOS policy began to take effect last year, the committee ended its investigations into numerous transplant programs, including the liver transplant program at Methodist.

Eason and a spokesperson for Methodist said that the investigation was closed because the program's outcomes had improved. (UNOS declined to comment on the reason.) Eason said in his statement to ProPublica and MLK50 that UNOS' new policy was recognition that UNOS had been relying on a transplant metric that was "outdated and invalid." He sees that decision as part of a broader shift in which federal transplant policy is falling more in line with his philosophy to offer transplants to as many people as possible.

With outcomes improving and policy shifting, Eason seemed poised to keep leading his team at the center that bore his name. But one morning this past August, Methodist transplant center employees were unexpectedly summoned into a meeting down the hall from where the renaming ceremony had taken place. For the prior week, Eason hadn't made his usual rounds through the halls of the transplant center. His staff even had to postpone a living donor transplant because of his absence.

Once the seats were filled, Michael Ugwueke, the president and CEO of Methodist's six-hospital health system, asked for everyone's attention. He informed them that Eason was no longer with the transplant center. When staffers asked what happened, Methodist executives said they couldn't provide any details. As part of the decision, the transplant center suspended conducting liver transplants for living donors.

Methodist and Eason declined to answer questions about his departure. Methodist has scrubbed many mentions of Eason from its website. In the six months following Eason's departure, he remained employed as the director of the Transplant Research Institute at the University of Tennessee Health Science Center, the medical school affiliated with Methodist. In late February, he retired from his tenured position, according to emails obtained through an open records request. UTHSC spokesperson Peggy Reisser declined to comment on the retirement.

So far, no hospital has publicly announced that Eason will lead its transplant center. Medical board records show that he has obtained licenses in Ohio and Pennsylvania. When ProPublica and MLK50 asked about Eason's departure and search for a new job, his lawyer, Sacksteder, responded in a letter on March 15 that he is a "highly respected" liver transplant surgeon whose name still graces the transplant center he had helmed.

Just a few weeks later, Methodist employees noticed something had changed at the hospital. Workers had removed several signs throughout the facility. The words "James D. Eason Transplant Institute" are no longer affixed to the front of the building.

A new sign simply reads: "Methodist Transplant Institute."

This story was produced in partnership with MLK50: Justice Through Journalism and co-published with the Commercial Appeal.

Max Blau covers healthcare, public health and the environment for ProPublica's South unit.

CMS data suggests that from 2017 to 2021 90 physicians billed for more than a third of all procedures and government payments, totaling nearly $1 billion.

This article was published on Wednesday, May 24, 2023 in ProPublica.

By Annie Waldman

In the suburbs of Maryland, Dr. Jeffery Dormu's presence is hard to miss. He's a regular on the local TV station, which has featured him and his practice five times over the past five years. And he smiles down from an electronic billboard outside a three-story vascular center he calls The Watcher. "It has a biblical reference, which is to watch over the community," he said at its 2018 opening. In response to the country's "tragedy of cardiovascular disease," the center trademarked the phrase "vascular devastation," a slogan frequently invoked in its marketing, along with a claim to have "saved over 34,000 lives and limbs."

Dormu and his group, the Minimally Invasive Vascular Center, have been a magnet for people with leg pain who worry they have peripheral artery disease, a condition that afflicts more than 6.5 million Americans and happens when fatty deposits narrow the arteries and block blood from flowing to the legs.

But Dormu's portrayal of his practice as a heroic refuge hid a distressing statistic: The vascular surgeon was performing an invasive leg treatment more often than almost any other doctor in the country, even when his patients didn't need it and even as evidence of harm mounted.

One man had to have his leg amputated after Dormu administered multiple invasive treatments for mild pain, according to legal filings. A 62-year-old grandmother bled out and died shortly after Dormu cut into her, according to another lawsuit.

Dormu's go-to procedure, the atherectomy, involved shaving blockages with blade-topped catheters. Best practices recommend that doctors hold off on invasive procedures like these, which can lead to complications including limb loss, on patients in the earliest stages of disease; doctors should first see how the patients do with exercise and medication. Dormu defaulted to atherectomies almost immediately, patient legal and medical records show.

Four years ago, leading researchers warned the Centers for Medicare and Medicaid Services that some doctors were potentially abusing interventions. The researchers implored the government insurer to scrutinize its own data to identify overuse, noting that some of the doctors could present an "immediate threat to public safety."

There is no public evidence that CMS meaningfully responded.

But a ProPublica analysis of CMS data suggests that if the agency had reviewed its own figures, it would have discovered that Dormu was part of a small pool of physicians performing a disproportionate number of treatments. From 2017 to 2021, the analysis shows, the top 5% of doctors conducting atherectomies — about 90 physicians overall — accounted for more than a third of all procedures and government payments, totaling nearly a billion dollars.

Near the top of the list sits Dormu, logging more atherectomies — and making more money from them — than almost every other doctor in America.

CMS paid Dormu more than $30 million in the past decade for vascular procedures he performed on hundreds of patients.

Dormu declined to be interviewed and did not respond to emailed questions.

But a chorus of experts told ProPublica that the federal government's decision to provide unconditional payments for vascular procedures — and then not pay attention to what happened — is a prime example of what's wrong with the American healthcare system.

"The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people," said Dr. Dipankar Mukherjee, a vascular surgeon and chief of vascular surgery at Inova Fairfax Hospital in Virginia.

CMS kicked off the problem 15 years ago, when it tried to rein in the swelling hospital costs for vascular care. Over the past few decades, advances in technology allowed patients with serious circulation problems to avoid open surgery and instead undergo minimally invasive treatment with cutting-edge devices. As they flocked to hospitals for these procedures, patients with clogged leg arteries became even more expensive than patients with clogged heart arteries.

In 2008, recognizing that the procedures could be done safely and more efficiently outside hospitals, CMS officials turbocharged payments to doctors' offices that deployed balloons and stents to widen arteries. And in 2011, they began to reimburse those offices for atherectomies.

Before the change, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800 respectively. But nothing compared to the payout for atherectomies conducted in offices: about $13,500 per procedure, as opposed to roughly $11,450 in a hospital.

Instead of saving money, the government started a boom.

Atherectomies increased by 60% from 2011 to 2014; Medicare's overall costs for peripheral vascular treatments climbed by nearly half a billion dollars, or 18%.

The government insurer didn't change course in 2014, when research began to indicate that atherectomies may not be more effective than cheaper alternatives, or in 2019, when experts warned the procedure may be associated with a higher risk of complications.

From 2013 to 2021, the most recent year of Medicare data, the number of atherectomies has doubled and payments to doctors have nearly tripled, totaling about $503 million in 2021.

"There's definitely places where atherectomy is very helpful," said Dr. Caitlin Hicks, an associate professor of surgery at Johns Hopkins University School of Medicine. "But it's definitely being used inappropriately, and that's when bad things happen."

Experts fear patients are being caught up in a new era of profit-driven procedure mills, in which doctors can deploy any number of devices in the time it takes to drill a tooth and then bill for the price of a new car.

The generous reimbursements have created a conflict of interest for doctors running their own practices, who are supposed to make unbiased medical decisions while also being responsible for a lease, overhead and staff. And unlike hospitals, which have panels and administrators who spot adverse events and questionable billing, these offices don't face such scrutiny.

CMS, experts say, should step up: It could reduce its reimbursements or even investigate doctors with outsized procedure patterns.

ProPublica reached out to CMS more than two weeks ago, listing the facts in this story, asking questions and requesting an interview. CMS did not make an official available to talk or provide any written answers.

"Vascular medicine now is the frontier of the Wild West," said Dr. Marty Makary, a professor of surgery and healthcare quality researcher at Johns Hopkins University School of Medicine. "People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible."

It was at the cusp of this lucrative new era in vascular medicine that Dormu, an ambitious young doctor from Washington, D.C., entered the scene.

After earning his medical degree at the New York Institute of Technology College of Osteopathic Medicine and completing an additional eight years of training in New York and New Jersey hospitals, including a residency in general surgery and two fellowships in cardiothoracic and vascular surgery, he received his license to practice medicine in Maryland in 2007. That year, he founded the Minimally Invasive Vascular Center.

"People in general are just afraid of surgery," he later told a local TV journalist. "They can get by with minimally invasive surgery, a needle puncture without having to be cut, without having to worry about an amputation. They walk in and within hours they walk out, and pretty much healed."

Dormu opened several vascular offices in the region. At one point, his group also partnered with the Washington, D.C., Department of Aging and Community Living, providing hundreds of free vascular screenings for elderly patients at senior centers and residences across the capital.

But according to public records and lawsuits, as his profile and his practice grew, so, too, did evidence of harm.

In March 2016, while he was performing an elective aorta repair at Providence Hospital, the patient began to hemorrhage, according to a District of Columbia Board of Medicine document on the incident. After trying to control the bleeding, Dormu transferred the patient to the intensive care unit for resuscitative efforts and then left the hospital for his private practice and other appointments.

He was gone for more than two hours, and in that time, hospital staff couldn't reach him. The hospital patient died in the recovery room from hemorrhage and organ failure, the report said. Six years later, the District of Columbia Board of Medicine would reprimand him for the incident alongside a $5,000 fine, finding that he abandoned a patient in need of further emergency care, "knowing the high risk of mortality and without adequate communication to other hospital staff."

The death of the patient did not interfere with his medical license or appear to slow his career.

Nine months later, a mechanic sought his care for mild leg pain. As the owner of his shop, Steve Rosenberg clocked long hours, six days a week, repairing anything with wheels or an engine. But as he reached his mid-50s, the long days of standing under vehicle lifts had begun to strain his legs.

His primary care doctor suggested that he see a vascular specialist and handed him a list of physicians to choose from. Dormu happened to have an office in the same plaza as Rosenberg's auto shop, between a jujitsu studio and a dentist's office.

He first visited Dormu's practice that December.

Instead of starting with more conservative treatment, Dormu deployed a trifecta of interventions on both of Rosenberg's legs within three months, widening his arteries with stents and balloons, and debulking his vessels with atherectomy devices, according to later legal filings.

Shortly after one of the procedures, Rosenberg's left foot grew numb and was cool to the touch. He went to the emergency room, where doctors discovered that one of his stents had clogged, hindering his vessel from carrying blood. 

Dormu called him back to his office, where he repeated the procedures: shaving the blockages, ballooning the artery walls and installing another stent.

The next day, he repeated the procedures again, ballooning his vessels and installing yet another stent.

Dormu sent Rosenberg to Providence Hospital in Washington, D.C., for further treatment. Within a day, his left foot had grown cold, a sign that blood likely no longer flowed freely through his vessels.

According to the terms of a legal settlement in a malpractice suit against Dormu, Rosenberg cannot comment on his care. However, public documents filed in his case, including assessments from medical experts, illuminate the cascade of procedures and the outcome.

A vascular surgeon Dormu retained for his defense, Dr. Garry Ruben, said the interventions were warranted; he said Rosenberg had been prescribed an anti-platelet medication, which he did not consistently take. In legal filings, Dormu blamed Rosenberg's injuries on his preexisting medical conditions and circumstances outside his control.

However, after reviewing medical records and diagnostic studies, Dr. Christopher Abularrage, an expert retained by Rosenberg and a professor at Johns Hopkins who specializes in vascular and endovascular surgery, found several "breaches of the standard of care." Dormu had failed to prescribe conservative therapy and lifestyle modifications first, he found, and "persisted with unindicated, endovascular interventions in the face of persistently poor outcomes and diminishing returns."

In less than six months, Rosenberg had been transformed from a patient with mild leg pain to one with a high risk of limb loss, he concluded.

Rosenberg spent nearly a week at Providence Hospital, the life slowly draining from his leg, before he was transferred to Washington Hospital Center on April 8, 2017, according to records. By then, his left leg was gangrenous and had no pulse. All of the stents had become blocked.

Without better options, doctors amputated his leg.

Between 2013 and 2017, Dormu earned about $14.5 million from Medicare — more than 99% of other vascular surgeons across the country — for treating hundreds of patients a year, the vast majority of them in his clinics.

In 2018, he was able to afford an upgrade.

The Watcher was not like other surgical centers. In its entrance stood a juice bar that could serve organic cold-pressed drinks to patients. Crystal chandeliers adorned its hallways. Moist air was pumped through its vents. And more than a dozen original modern paintings lined its walls, making it feel like an art gallery. "We wanted it to give that shock and awe," Dormu said in a video interview from the facility's opening day.

His clinic provided a litany of medical services, including treatments for uterine fibroids, erectile dysfunction and varicose veins, as well as elective nonsurgical fat reduction.

The expansive facility boosted Dormu's earnings. From 2018 through 2021, he earned nearly $18 million in Medicare payments for all of his clinic's activities.

One procedure stood out from the rest: Nearly $12 million of that came from atherectomies, according to Medicare data.

He performed one on Alice Belton, a high school nursing teacher who sought help in 2018 for lower extremity pain, numbness and tingling. Her artery blood flow was normal; even Dormu noted that she didn't have severe leg pain, according to an ongoing lawsuit. And yet, he conducted multiple procedures over about a year, shaving plaque, ballooning her vessels, treating her veins and running invasive scans; the procedures were unnecessary, according to a medical expert retained in her case.

Belton says she has since developed permanent nerve damage in her leg, which has prevented her from working full time. In legal filings, Dormu denied the allegations and claimed that the alleged injuries were caused by preexisting conditions.

"The experience with Dr. Dormu has shaken my confidence in healthcare practitioners and more importantly in myself," she said. "I feel duped that this surgeon convinced me, a nurse, that my problems required such radical surgical interventions."

And then there was John Malinich, who had no leg pain but wanted to get his circulation checked in 2019 after he saw Dormu's billboard. At first, Malinich didn't question Dormu's treatments; the doctor's confident demeanor and lavish facility impressed him and put him at ease.

"After surgery on both of my legs, they wanted me to go back and do it over again," he said. "After that, I started getting suspicious."

He said he got a second opinion from another vascular surgeon who informed him that the prior procedures, which involved balloons, an atherectomy and a stent, had been unnecessary. To ensure his stent doesn't collapse or clog, doctors now have to annually monitor Malinich. He filed a lawsuit against Dormu, who has denied allegations of overtreatment. The case is ongoing.

"I trusted the guy," Malinich said. "But it was just to make money."

The next year, Heather Terry was looking forward to her mother's return home after a six-month stint rehabilitating in a nursing home. For years, Heather had helped take care of 62-year-old Linda Terry, who had debilitating epilepsy. After a fall down a flight of stairs and subsequent back surgery, Terry was left paraplegic and unable to walk.

Just before she was supposed to be discharged from the nursing home in August 2020, the staff told Heather Terry that her mother had leg pain and ulcers on her heels that needed treatment. According to her family, Linda Terry had no prior circulation issues. The procedure was simple, the staff said, and would be conducted in a clinic just down the road.

On Aug. 13, Terry was transferred to Dormu's center, where he started an atherectomy procedure, inserting the small tube capped with blades into her vessels to shave the plaque from her artery walls.

Less than 15 minutes into the treatment, her blood pressure began to drop.

With atherectomy, there's always a risk that the device may dissect the vessel, which would require immediate care.

Dormu aborted the procedure and brought Terry into the recovery area. She was drowsy and her blood pressure continued to waver, signs that she may have been bleeding internally, according to her family's attorney. Instead of being rushed to the emergency room, legal filings show, she was sent back to the nursing home, where she became unresponsive.

The nursing home called an ambulance, which ferried her to the emergency room at the University of Maryland Laurel Medical Center. Three hours later, she was pronounced dead, according to the lawsuit, a consequence of severe anemia due to internal blood loss.

For the aborted procedure, according to the family's attorney, Dr. Zev Gershon, Dormu charged her insurance about $20,000.

Heather Terry believes that if Dormu had treated her mother with appropriate care and transferred her directly to the hospital, she might have survived. "It went from ‘She's going to come home tomorrow' to ‘She's dead,'" said Terry, whose ongoing malpractice case against Dormu is set to go to trial this year.

In legal filings, Dormu denied any involvement in her mother's death. He said in a deposition that he did not see evidence of bleeding and that Linda Terry's anemia could have been due to a prior fall. He said he also gave a directive to send her to the hospital after the aborted procedure, despite EMS records obtained by the family's attorney showing that Terry was sent back to the nursing home.

"I trusted doctors," Heather Terry said, "but now I'm starting to think that maybe they shouldn't be as fully trusted."

By 2021, Dr. Kim Hodgson, a former president of the Society for Vascular Surgery, recognized that unfettered profiteering in his field was not just a threat to patients, it also stood to damage the credibility of his speciality. Notably, abuse in outpatient vascular facilities was the No. 1 complaint he had received from members. That August, the vascular surgeon stood before hundreds of doctors at the society's annual conference and made a plea.

"Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place," he said. "We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources."

In dozens of slides, he laid out evidence exposing the magnitude of the crisis: the Medicare incentive, the explosive growth of procedures in clinics and the potential for inappropriate treatment. Most critically, he warned about the risk of patient harm. In recent years, researchers have found that patients in early stages of vascular disease had less than a 2% risk of amputation after five years. However, with aggressive interventions, that risk could surge up to 5% or even 10%.

"The problem is that these behaviors — unindicated early interventions and overuse of unproven technologies — still have costs and more often than not, those costs are borne by our patients," he said. "We can and should do better, otherwise we are also enablers."

The issue has magnified into a crisis that has splintered the specialities that conduct these procedures, which include interventional radiologists, cardiologists as well as vascular surgeons. Some physicians do not view overuse as an urgent problem and feel the recent academic attention unfairly stigmatizes private practice doctors.

"The majority of operators are doing the right thing," said Dr. Jeffrey Carr, an interventional cardiologist and the founding president of the Outpatient Endovascular and Interventional Society, which represents physicians working in outpatient settings. "We need to call out the bad actors, but to cast a narrative that puts us all in the same arena is wrong."

Other doctors recognize a need for considerable reforms.

CMS could reverse the change that kicked off the entire problem, some experts said, by reducing its outpatient reimbursement rates. "If you shut off the money, the whole thing will stop tomorrow," Mukherjee, the Virginia vascular surgeon, said.

But such cuts might hurt doctors practicing responsibly and could even nudge the least scrupulous ones into higher gear to make up the financial difference. "You could incentivize people to do more procedures, and some of them may be inappropriate," said Dr. Peter Lawrence, the former chief of vascular and endovascular surgery at the University of California, Los Angeles, who developed an outpatient center connected to the university.

More critical than payment cuts, Lawrence said, is greater oversight of office-based facilities. Many states don't require doctors in those settings to have special vascular training or hospital privileges in case of complications, he said. "You could be a psychiatrist and do these procedures," he said.

Many physicians also support improved data collection, particularly for newer technologies like atherectomy, to ensure that they're not only safe but result in improved outcomes.

"Many of the vascular procedures that are done are relatively safe or can be done with good short-term results, but the failures are long term — it's what happens in two to five years," Lawrence said. "Unless you have a reimbursement system, which not only pays you for the initial procedure, but whether or not it's durable, you can have procedures done in our society that have great short-term results but have poor long-term results."

CMS could require physicians to participate in patient registries, said Dr. William Schuyler Jones, an interventional cardiologist and associate professor of medicine at Duke University School of Medicine. "That type of required reporting would make our system better," he said, "and would ultimately put the onus on all of us to do more appropriate care."

For Dormu, patients were the ones to prompt accountability, airing their grievances to the Maryland Board of Physicians. Among them was a woman who sought his care for excessive leg itching and said he tried to pressure her into an invasive artery scan. When she sought a second opinion, the doctor concluded that her itching likely stemmed from a reaction to an insect bite.

The medical board examined the records of 11 of Dormu's patients. Two peer reviewers, board certified in vascular surgery, independently concluded that Dormu had performed "medically unnecessary and invasive vascular procedures" and failed to meet appropriate standards of care for 10 of the 11 patients, "exposing them to potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient's circulation, and limb loss."

One patient who sought Dormu's care to evaluate blockages in their legs could walk a mile before treatment, but after the procedures, they could not walk at all.

"There exists a substantial likelihood of risk of serious harm to the public health, safety, and welfare in Dr. Dormu's continued practice," the board's executive director, Christine Farrelly, concluded.

Last October, the board found him in violation of state medical law, citing his overuse of procedures and his failure to uphold standards of care. It fined him $10,000, suspended him and put him under a two-year probation, during which he must be supervised and enroll in an ethics course.

Maryland Department of Health spokesperson Chase Cook said the agency's Office of healthcare Quality, which is responsible for oversight of the state's surgical centers and licensed Dormu's current facility, was not aware of his sanctions nor the allegations of harm. The office "will follow-up in accordance with federal and state regulations," Cook said.

Despite lacking an active license to practice medicine in Maryland, Dormu is still listed on his clinic's website as the lead vascular surgeon, "currently available for office visits and in-patient consultations."

When ProPublica called Dormu's office to inquire whether he was still practicing, the receptionist said he was no longer seeing patients and that "Dr. Seibles" was providing all the same services. According to the Virginia Board of Medicine's directory, Dr. Ayana Jonelle Seibles spends 20% of her time practicing at Dormu's center in Maryland.

An emergency medicine physician who does not have specialty training in vascular surgery, Seibles appears to have a close relationship with Dormu; according to county property tax records, they have owned a home together since at least 2017. Seibles did not respond to ProPublica's questions that were sent by email.

In a lawsuit deposition last month, Dormu said that he stopped doing surgery this year as a "personal choice." When asked the name of his supervisor, he stated that he couldn't recall it. He also couldn't recall how many times he had been sued for malpractice, any of the details of the cases, nor the names of the attorneys representing him. He also couldn't specify how many atherectomies he had performed, only estimating that he had done more than 100.

According to Medicare data, over the past decade, he has done at least 3,400.

For most of his life, Rosenberg trusted doctors; his own father was one. But the mechanic has lost faith in medicine. Memories of his 2017 amputation have been largely buried by the trauma, but he recalls lying in his hospital bed after the operation, the remnants of his left leg wrapped in a cloud of white bandages. "Life isn't supposed to turn out like this," he said.

He was discharged to his three-story colonial home, where two steps led to the front door and 13 steps gave way to the second floor; he could only ascend them by crawling backward. Eventually, he sold the house and his family moved into a flat, ranch-style home.

He tried to maintain his auto shop, relying on his wife and teenage stepson to help out. But with his limited mobility, first in a wheelchair and later maneuvering with his prosthetic and a cane, he could not repair cars like he used to and was forced to sell his business and retire.

Before, he could get dressed and out the door in less than 30 minutes; it now takes more than an hour. He used to prepare meals for his family, but after, his stepson had to learn how to cook. In the months following the surgery, he often fell asleep by 7:30 p.m., tired from carrying his body around all day. Discomfort would awaken him by 4 a.m.

Half of his days are now spent navigating the complex web of amputee providers, arguing with insurance agents, attending physical therapy and meeting with specialists to keep his vascular system in check.

Above all, managing the pain has remained a lingering burden. Even though he lost most of his left leg, its memory has been indelibly burned into his brain, haunting him like a phantom. Sometimes the bottom of his missing foot itches or a jolt surges down his absent calf.

"And there's nothing anyone can do about it," he said, "because it's not there."

Annie Waldman is a reporter at ProPublica covering healthcare.

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Beers family members built a 'conglomerate' by selling a Christian alternative to traditional health insurance. They're now scrambling for cash, even though they received millions in PPP loans that were later forgiven.

This article was published on Monday, May 15, 2023 in ProPublica.

By J. David McSwane and Ryan Gabrielson 

In just a handful of years, members of a Canton, Ohio, family built a financial empire that included a boutique airline, a bank in the Missouri Ozarks, a chain of carpet stores, a marijuana farm in Oregon, and more than $20 million in real estate. The "conglomerate," as the Beers family calls it, was made possible by hundreds of millions of dollars collected from Americans who thought they had found an affordable alternative to medical insurance. Instead, many were saddled with debt.

The conglomerate, however, is showing signs of strain as the family downsizes its workforce and sells off some of its holdings. These moves will free up cash, said an attorney who represents several family members, and allow them to pay off a court settlement related to its alleged fraud. Now, another big debt has come their way: Several family members face liens placed against their properties for millions in back taxes.

A ProPublica investigation earlier this year revealed how Liberty HealthShare — the Christian nonprofit the family controlled and marketed as a cheap way to circumvent Obamacare requirements — paid at least $140 million to vendors owned by members and friends of the Beers family. Those family members and friends then funneled the money through a network of shell companies to purchase scores of businesses. As the family amassed wealth, Liberty's finances were depleted and thousands of members' medical bills went unpaid.

As part of the settlement with the Ohio attorney general's office in 2021, Liberty HealthShare severed all ties with the family.

Members of the family, including patriarch Daniel J. Beers, and their attorneys, have denied wrongdoing. They claim that the family-owned vendors — Cost Sharing Solutions and Medical Cost Solutions LLC — charged Liberty market rates or less for their services, which included running a call center and negotiating bill payments with doctors and hospitals.

In January, Cost Sharing Solutions laid off all but a handful of staff, according to current and former employees. "They have no money," said one source who asked to remain anonymous because of the nondisclosure agreements that the company required employees to sign. "It's all gone." From 2014 to 2021, Liberty paid Cost Sharing Solutions at least $90 million.

Last month, members of the family auctioned off more than 470 acres they owned outside of Canton. Those parcels constituted roughly half of the Lazy L Ranch, the compound where most of the family lives. "From its hilltop panoramic views to wooded valleys and open farm fields, this property will take your breath away," the auction notice read. Purchase prices and the identities of the buyers have not yet been made public.

The IRS has recently secured liens against parcels of the ranch that family members still own. Property records show that Beers' sons, Danny and Ronnie, owe $2.9 million and $1.1 million in federal income taxes for 2017 to 2021. Brandon Fabris, who also lives on the ranch and serves as chief operating officer of Cost Sharing Solutions, owes more than $700,000 in federal taxes.

Family members have also recently sold their controlling stake in Ultimate Air Charters, a small airline that caters to gamblers who travel from Canton to locales such as Atlantic City. Rick Arnold, the attorney who represents Beers and many of the companies that family members own, said the airline was sold to an entity outside of the family. He would not disclose its identity, which also has not been made public in Ohio business filings, and did not respond to questions about the federal tax liens on the Beers and Fabris homes.

In addition to the monthly dues that Liberty members paid for coverage of their medical bills, all of these ventures benefited from taxpayer money. Seven entities in the conglomerate received more than $6.3 million in COVID-19 relief funds, the vast majority of which was forgiven by the federal government, according to a ProPublica analysis of Paycheck Protection Program data. Cost Sharing Solutions, claiming it would save 168 jobs, obtained more than $1 million in April 2020 and another $1 million in January 2021. Ohio Lazy L Ranch LTD collected more than $80,000, and Ultimate Air Charters secured more than $2.9 million.

Arnold said the layoffs and sales are a way for his clients to pay $5 million in collective damages from the settlement with the Ohio attorney general's office. Although the agreement with the state calls for monthly payments, Arnold says his clients have negotiated a new deal to send a lump sum "within the next couple of months."

"It was part of a greater business plan," Arnold said of the recent transactions. "It also creates liquidity and allows them to pay the attorney general."

Beers and the two family-controlled vendors have missed several payments and are in arrears for $290,000 and $690,000, according to records from the attorney general's office. A spokesperson for the Ohio attorney general said the payment schedule and agreement have not changed, despite Arnold's claim.

In 2021, Liberty members whose medical bills languished and were referred to collections filed a class-action lawsuit against the Beers family, the ministry and the two vendors. The defendants have filed a motion to dismiss, which is pending.

J. David McSwane is a reporter in ProPublica's Washington, D.C., office covering health care, energy, federal contracts and land issues.

Ryan Gabrielson is a reporter for ProPublica covering healthcare.

A ProPublica analysis of FDA data reveals that the agency only inspected 6% of the overseas plants where drugs and their ingredients are produced in 2022.

This article was published on Wednesday, April 19, 2023 in ProPublica.

By Irena Hwang

For years, U.S. pharmaceutical companies have relied on drugs produced overseas to meet Americans' medical needs. And for years, it's been clear that federal drug regulators couldn't keep up with inspections of the plants that made those drugs.

But a series of recent deaths linked to eyedrops produced overseas that were tainted with bacteria points to just how seriously behind the Food and Drug Administration is. Three people died and eight others were blinded in the United States from the drops, which were made in a plant in the Indian state of Tamil Nadu that the agency had never inspected prior to the outbreak. Worse, public health officials say they have detected the drug-resistant bacterial strain, which had never been seen in the U.S., among patients who never used the eyedrops, meaning it has likely achieved community spread.

A ProPublica analysis of FDA inspection data as of April shows that the agency's inspections of overseas drug manufacturers, located mostly in India and China, has dropped precipitously even as the number of manufacturers has remained relatively steady. In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in 2022, the agency only inspected 6% of around 2,800. And in India, where the contaminated eyedrops originated, the FDA inspected only 3% of manufacturers in 2022 — significantly less than in 2019, when 45% of plants were inspected.

The FDA, which is tasked with ensuring the safety and efficacy of both prescription and over-the-counter drugs, has acknowledged that limited resources make it impossible to inspect every plant, whether in the U.S. or not, that makes drugs or their ingredients. But the agency has been slow to make improvements.

This is not the first time that American consumers have been injured or killed as a result of contaminated drugs produced overseas. In the 1980s, drugs manufactured in Italy intended to prevent seizures resulted in epileptic seizures and two deaths. In 2007 and 2008, hundreds had allergic reactions, some fatal, to a commonly used blood thinner, prompting an FDA investigation. Some of the cases were later linked to an ingredient produced in a facility in China that had never been inspected by the FDA.

The Government Accountability Office, a federal watchdog agency, has warned for decades that the number of overseas inspections was worryingly low. Just weeks before the first cluster of COVID-19 patients was reported in China at the end of 2019, the GAO reported that despite some improvements in how the FDA tracked and prioritized its efforts, inspections of both foreign and domestic drug plants were on the decline, due in large part to challenges retaining staff and filling vacancies.

"While our drug supply is generally safe, problems do occur, as evidenced by contaminated eye drops in the last few months," said Mary Denigan-Macauley, director of public health at the GAO. "No one wants to lose their vision or an eye simply from taking eyedrops to alleviate dry eyes."

Without a doubt, the COVID-19 pandemic slowed inspections to a trickle — in fiscal year 2021, according to the data, the agency inspected a mere 99 overseas sites, less than 4% of eligible foreign manufacturers. By comparison, 15% of domestic manufacturers were inspected that year. (Nearly three-quarters of manufacturers of U.S. drug ingredients, and more than half of producers of finished drugs, are located overseas.)

During the pandemic, the FDA began announcing domestic visits beforehand and paused surveillance visits overseas except for those deemed "mission critical," conducting most preapprovals of new drugs without visiting foreign manufacturing sites.

The FDA defended this decision in an email statement to ProPublica, saying it used "alternative inspectional tools such as remote interactive evaluations, record requests, and leveraging information from trusted regulatory partners."

Both the GAO and Rep. Sanford J. Bishop, a Georgia Democrat, say these remote interactions do not offer the same insight that in-person, unannounced inspections do. The FDA itself affirmed the utility of inspections in its latest annual report on pharmaceutical quality: "In the absence of inspections, many of these situations" that could result in defective products, "and possible public harm, could have gone undetected."

But three years after the pandemic started, the FDA has been slow to return to pre-pandemic inspection rates. The pandemic heightened the urgency surrounding the FDA's drug inspection process, as the need for more equipment, vaccines and antiviral medications, many of which are produced overseas, increased. Though routine domestic surveillance inspections resumed in July 2021, routine foreign inspections remained on hold until February 2022.

In December, President Joe Biden signed a year-end spending package that allocated $10 million for a pilot program to "increase unannounced foreign inspections" of drug makers. But that was just a tiny fraction of the $3.5 billion earmarked for all FDA drug quality oversight programs.

"We have got to be protective of the health, safety and welfare of the American people," said Bishop, who pushed for funding for overseas inspections in the House. "That is the job of the FDA."

Experts hope the pilot program will address standards surrounding those visits, which have drawn criticism for being too permissive. Unlike domestic inspections, foreign manufacturers were routinely given a heads-up before an inspection and allowed to provide their own translators, practices that FDA inspectors have admitted could make information gathered unreliable. The FDA said that it planned to use the additional $10 million to increase staffing for foreign inspections and to work on prioritizing inspections that the agency was unable to perform during the pandemic.

Among the foreign establishments never inspected was a Global Pharma Healthcare factory in Tamil Nadu that produced artificial tears sold by U.S. companies EzriCare and Delsam Pharma. As an over-the-counter product that does not require FDA approval, the eyedrops fell into another FDA regulatory blind spot. Though the FDA has the authority to inspect manufacturers of over-the-counter products before they are sold to consumers, there is no requirement that an inspection must occur prior to the sale — unlike for prescription drugs.

The FDA is asking Congress to require that manufacturers notify the FDA of their intent to distribute over-the-counter drugs well in advance of selling them, potentially providing the FDA a "feasible opportunity" to conduct inspections.

But even that requirement might not have made much of a difference. According to the GAO's 2022 report on FDA foreign inspections, a growing backlog of manufacturers slated for routine surveillance inspections is skewing in a concerning direction. The percentage of overseas manufacturers that hadn't been inspected within five years, or which have never once been inspected, has grown from 30% in 2020 to more than 80% in 2022. And if the FDA prioritizes sites that have not been inspected recently, that might come at the expense of inspecting sites identified by the FDA as posing the highest public health risk.

Preventing future public health risks, like the ongoing eyedrop outbreak, has to be a priority, said Denigan-Macauley of the GAO.

"These problems are not hypothetical. They are real," she said.

In the case of the imported tainted eyedrops, in January, the FDA and the Centers for Disease Control and Prevention traced back the Pseudomonas aeruginosa outbreak to the Global Pharma Healthcare-produced EzriCare Artificial Tears. That same month, the FDA requested records from the manufacturer regarding an unrelated issue and, concerned by Global Pharma's "inadequate response," placed it on an import alert, preventing its products, including the eyedrops, from entering the U.S. In early February, the FDA recommended a recall of the EzriCare and Delsam Pharma eyedrops, though it waited weeks to finally conduct an on-site inspection, only to find multiple sanitary and safety issues. The companies did not respond to a request for comment, though in a February press release EzriCare said that it was cooperating with the CDC and FDA. Global Pharma has said to The New York Times it is "fully cooperating with U.S. federal authorities."

Irena Hwang is a data reporter at ProPublica.