A Hole in the Heart

The throbbing near Marian Simmons’s temples made her nauseous. She could barely tolerate opening her eyes; the light brought on an excruciating sensation, as if a helmet was cinched too tightly on her head. Simmons, who was 20 years old and healthy, now struggled to get out of bed in her dorm at Westminster College, a small liberal-arts school in Salt Lake City. Simmons asked a friend to drive her to the emergency room. The staff didn’t find anything out of the ordinary and referred her to a neurologist, who ordered an MRI. Once again, everything looked normal. The neurologist encouraged her to see a prominent Salt Lake cardiologist, Sherman Sorensen.

About a week later, Simmons and her mother arrived at Sorensen’s office, where a technician administered a type of echocardiogram known as a “bubble study.” The test involved intravenously injecting a mixture of saline solution and air, and tracking air bubbles with a handheld wand as they traveled toward Simmons’s heart. “Oh, that’s bad,” Simmons recalls the tech saying as he observed the results on an ultrasound monitor. Simmons’s mother held back tears.

When Sorensen arrived in the exam room, he explained that the test indicated that Simmons had a tiny hole between the upper two chambers of her heart, what’s known as a “patent foramen ovale,” or PFO. Sorensen, who was in his late 50s, had short gray hair and a matching silver mustache and wore a white lab coat over his shirt and tie. He spoke with no hesitation. Sorensen told Simmons that individuals with PFOs have a high risk of stroke, and that’s probably what she’d experienced on the day she checked herself into the emergency room. What’s more, he said, her PFO might have already caused her to have other mild strokes and could lead to a more severe—even fatal—one. He asked Simmons if she wanted to have children and then told her that she could die during childbirth if she didn’t get her PFO repaired. There was good news, though. Sorensen said he could implant a small device to plug the hole and, if he did this, she wouldn’t have to worry. The whole discussion lasted about 15 minutes.

Simmons scheduled the surgery as soon as possible; Sorensen was booked for the next several weeks. At the time of Simmons’s operation, in summer 2009, Sorensen had been conducting PFO closures for nearly a decade and was considered one of the country’s prominent practitioners. Colleagues referred to him as brilliant. As she and her mother left the building, the woman working at the front desk remarked that it was a good thing Simmons had met Sorensen. “The atmosphere in the office was all very dramatic,” Simmons told me. “They were acting like I was going to drop dead any day.”

Worried that she’d accidentally induce a stroke that would kill her, Simmons was terrified of making sudden movements. Mostly, she holed up in her dorm room. When she did leave, she walked or asked her boyfriend to drive her places. Simmons’s surgery happened to be scheduled on the day after her 21st birthday. Instead of celebrating that night with friends at a bar, she climbed under the covers around 9 p.m.

The PFO-repair procedure involves making a small incision in a patient’s groin and then funneling the closure device up into the heart. Once it’s in the correct spot, the doctor pops the device open like a tiny umbrella, plugging the hole. As far as surgical interventions go, the procedure is considered an efficient, elegant maneuver. Following the operation, Sorensen told Simmons that the hole in her heart was one of the biggest he’d seen. After living for weeks concerned that the most critical organ in her body was damaged, she now felt safe.

But within six months, Simmons began to experience wide-ranging medical problems. She felt as if she constantly had a bad case of the flu. She had digestive trouble—an irritable bowel and horrible bouts of nausea. Her vision occasionally became blurry, and she had an unusual, almost metallic, taste in her mouth. She had night sweats and inexplicable rashes. None of these symptoms was typical for patients who had undergone a PFO procedure, which is regarded as safe and has few side effects. Simmons booked appointment after appointment with specialists, but nothing helped. “It felt like I was dying, and we didn’t know why,” Simmons told me.

Read: Why some doctors purposely misdiagnose patients

The next six years were a struggle. Simmons had managed to graduate from college and was happily married to her longtime boyfriend, but she had difficulty working full-time, and medical bills were piling up. On a winter night in 2016, Simmons and her husband curled up on the couch to watch Survivor. During a commercial break, an advertisement for a local law firm aired. The ad encouraged anyone who’d had a PFO closure in the state of Utah from 2001 to 2011 to call the number on the screen. Simmons’s husband turned to her. “That would’ve been you, right?”

Although few people outside medicine have likely heard of a patent foramen ovale, it’s common. During the embryonic stage of human development, a small opening covered by a tiny flap—the foramen ovale—forms between the two upper chambers of the heart. In most people, the valve closes and the hole seals during infancy; for about one out of four individuals, however, the tiny cavity remains. Most people with PFOs never learn they have the condition—it has no typical symptoms or side effects. In the medical world, it’s considered a normal anatomic variation.

More than 25 years ago, cardiologists stumbled onto a possible correlation between PFOs and risk of stroke. Strokes occur when blood traveling to the brain is either cut off or significantly reduced, preventing the flow of essential oxygen and nutrients. Doctors have identified two main causes: an obstructed artery or a leaky blood vessel. In the case of a cryptogenic stroke, however, the cause is unknown. But in people who’d had cryptogenic strokes, doctors noticed a higher instance of PFO. The hypothesis was that an otherwise harmless blood clot could lead to a stroke by passing through the PFO to the left ventricle and traveling to the brain.

At the time of Simmons’s surgery, PFO closure was viewed as an appropriate treatment only for those who’d had more than one confirmed stroke of unknown origin and for whom no other medical treatment had worked. That guidance was codified in the mid-2000s by the American Heart Association and the American Academy of Neurology. Closing a PFO in someone who’s not experienced a stroke has never been recommended. “Having a PFO is not a risk factor for stroke in general,” John Carroll, a cardiologist and a professor at the University of Colorado School of Medicine, told me. “In most people,” he said, “it’s an innocent remnant of the fetal circulation. You could close a quarter of the U.S. population and probably bring benefit to a very small number of those people.”

Born and raised in Salt Lake City, Sorensen attended Cornell University Medical College in New York City. In the early 1980s, he joined the cardiology division at LDS Hospital, in Salt Lake City, which is operated by the nonprofit Intermountain Healthcare, the largest health-care provider in the Mountain West. Throughout the 1990s, Sorensen served as the director of Intermountain’s cardiac-catheterization laboratory, or “cath lab” for short. Around the turn of the century, though, he began to shift his surgical focus. Within a few years, by some estimates, Sorensen himself was performing more PFO closures than any hospital in the United States, a volume that was 10 to 20 times higher than the national average and accounted for perhaps as much as 10 percent of closures worldwide. Records indicate that in 2010, Sorensen performed 861 closures; that same year, doctors at the Cleveland Clinic performed 37 PFO closures. Around the same time, doctors at the Mayo Clinic performed fewer than 50 a year.

The volume and manner of Sorensen’s PFO practice did worry some doctors in the Utah medical community. Nancy Futrell, a neurologist who worked with Sorensen, told me that he’d closed PFOs regardless of whether patients fit into the accepted medical guidelines. “I saw him close people who didn’t need to be closed,” Futrell said. In spring 2008, Andrew Michaels, a cardiologist and a professor of medicine at the University of Utah, sent an email with the subject line “confidential” to Donald Lappe, the chair of the cardiovascular department and the chief of cardiology at Intermountain Medical Center Heart Institute. (Lappe declined to comment for this story.)

The email went on.

Gerald Polukoff arrived in Salt Lake City for a faculty position at the University of Utah in 2000. He soon heard about a skilled cardiologist performing a large number of PFO closures. Polukoff didn’t pay much attention at first; as a 40-year-old physician new to the area, he was focused on establishing his own practice, getting his family settled, and exploring the ski slopes in the nearby Wasatch Mountains. Seven years later, Polukoff accepted a position in the cardiology department at Intermountain. Once he was practicing in the same building as Sorensen, he started to hear more about the number of PFO procedures—hundreds, if not thousands.

Polukoff sensed that some Intermountain doctors were uncomfortable with Sorensen’s high-volume PFO business, but that no one seemed to express any disapproval. In fact, Polukoff told me, “it had been woven into the fabric of the medical community as normal.” Meanwhile, the hospital was being recognized nationally as a model of success in the health-care industry. In 2009, the same year Marian Simmons elected to have Sorensen close her PFO, President Barack Obama singled out Intermountain as an example of a medical provider delivering quality coverage at an affordable cost. Commenting on Obama’s remarks, Intermountain Medical Center’s senior vice president Greg Poulsen told a local TV station: “I think that in Utah, that the providers here often do the right thing in spite of the fact that it’s not what is financially rewarded.”

In summer 2011, Sorensen approached Polukoff about a job. The offer caught him off guard. Still, despite the concerns he’d heard about Sorensen, Polukoff was flattered that a doctor of his stature wanted to hire him. “I felt like I was the golden child,” he told me. Polukoff said that Sorensen’s practice by then had become almost exclusively a PFO-closure business, and that he joined on the condition that he could observe about a hundred procedures before handling any himself. That took about two months; according to Polukoff, Sorensen was doing eight or 10 closures a day, twice a week.

While Polukoff trained with Sorensen, Intermountain was in the process of auditing Sorensen’s PFO practice. An internal committee reviewed 47 procedures Sorensen had conducted during April 2011. The audit concluded that “compliance with the guidelines for performing PFO closures” was “less than ideal.” The hospital suspended Sorensen for 14 days pending further review. The results of the audit were circulated to the Intermountain cardiology department. The hospital also instituted an additional check: Doctors would need to document each PFO case and seek approval from the head of the hospital’s cardiac-catheterization committee before operating.

Following his two-week suspension, Sorensen returned to work. According to court documents, he continued to perform closures on people who did not meet Intermountain’s newly established criteria. In September, the hospital threatened to suspend Sorensen permanently and report his conduct to the National Practitioner Data Bank, a catalog of medical-malpractice settlements and complaints. Instead, Sorensen resigned. He moved his practice down the road to St. Mark’s Hospital, where he had operating privileges. St. Mark’s is run by HCA Healthcare, one of the largest for-profit operators of medical facilities in the country.

Polukoff was still new, and he wondered whether this was all a matter of differing medical opinion. But at St. Mark’s, Polukoff sat in on meetings with patients and scrubbed in on procedures, and he was startled by what he saw. He listened to Sorensen deliver the same, well-rehearsed speech over and over, a soliloquy that Polukoff felt played with the truth. “Dr. Sorensen is a very impressive, domineering individual who dealt with patients who feared a catastrophic event,” Polukoff told me. “He assured them that he would fix their hole and they wouldn’t have a stroke.” He added, “That was the mantra.”

Read: When evidence says no, but doctors say yes

On two occasions, Polukoff said he witnessed Sorensen operate on people who were thought to have a PFO but did not. Instead of aborting the procedure, Polukoff said that Sorensen decided to create his own opening and implant the closure device. “That was done twice in elderly patients while I was assisting,” Polukoff told me. Polukoff said that he also observed Sorensen misrepresent people’s diagnoses on their medical charts so that insurers would reimburse for the procedure. Polukoff had seen enough. He approached Sorensen one night and attempted to raise his concerns. Before he had a chance to get into it, Polukoff said Sorensen told him “we’re done here,” which Polukoff took as the end of their business relationship. A few months later, Sorensen called it quits, retiring from practicing medicine at age 67.

In December 2012, Polukoff filed a civil lawsuit in federal court. The action was brought under the False Claims Act, a statute that allows whistleblowers to bring complaints against individuals or businesses that have defrauded the federal government. The case against Intermountain, St. Mark’s, and Sorensen Cardiovascular Group alleged that Sorensen had fraudulently billed Medicare and Medicaid for thousands of medically unnecessary PFO closures. Polukoff’s legal team ran TV ads soliciting calls from anyone who’d undergone a PFO closure in Utah from 2001 to 2011. Within days, hundreds of people had contacted the office.

Marian Simmons didn’t know what to expect when she dialed the number she’d seen on the TV ad during Survivor. When someone at the law office picked up and explained why attorneys were gathering information, Simmons froze. For six years she’d searched for an answer as to why she felt so weak. Now here it was. Simmons learned that many of the PFO closures Sorensen had performed might not have been necessary. When Simmons had had her procedure, the medical guidelines for who qualified for closure were limited: Patients needed to be properly diagnosed with a cryptogenic stroke. The neurologist she’d seen said that her MRI was clean—no indication of a recent stroke—and that she’d likely experienced a migraine. The first time she’d heard the word stroke was in Sorensen’s office. In her case, there was more. The device Sorensen implanted in her heart was made of a metal alloy that contained nickel, something she and her mother had specifically asked about that day in Sorensen’s office because Simmons is allergic to nickel. “That was my worst fear,” Simmons told me. “I felt like, Oh my God, he lied to my face, and now it’s inside my body. What am I supposed to do?”

Simmons now had to decide whether to have the PFO device removed. Although the procedure to have the device implanted is considered straightforward, removing the device is significantly riskier. Staff hook a patient up to a bypass machine that can temporarily pump blood through their body. A surgeon then slices into the patient’s chest and cuts out the device, which, at that point, is usually enclosed by tissue. The surgery lasts several hours, and recovery can take weeks. Simmons was hesitant to allow herself to think that this might magically cure her; that’s what Sorensen had promised years earlier.

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In the end, Simmons felt like she didn’t have much of a choice. She completed a medical directive to include in her will and handwrote letters to family members and loved ones. The letter to her husband began, “I’m so sorry I died during surgery and left you alone.”

Her first thought after waking in the ICU was that she’d made it. “I felt this clarity in my body,” Simmons told me. As she continued to feel better, her old life slowly returned. She started up her morning gym routine and went hiking with her husband and the dogs on the weekend. She never had another incident like the one at college that caused her to seek emergency care. But Simmons also said the realization that she’d been duped by Sorensen weighed on her. “I felt so stupid and so ashamed of myself,” she said. “I don’t think I’ve ever had a stroke.”

Sorensen’s appetite for the PFO procedure raises a fundamental question about how surgical interventions, and thus how surgeons and other specialists, are regulated—a topic that’s often missing from the political debates about health care on Capitol Hill and in statehouses around the country. Those discussions tend to focus on two things: cost and access. Whether a person will benefit from any given treatment, so long as it’s affordable and accessible, is given much less consideration. Four decades before Simmons underwent the procedure to close her PFO, a House subcommittee published a report that found doctors had performed an estimated 2.4 million “unnecessary operations” annually. Those surgeries reportedly cost $3.9 billion and led to nearly 12,000 deaths.

In 2017, the journal Plos One published a survey of 2,100 American doctors. Sixty-five percent of the respondents reported that 15 to 30 percent of all medical care was unnecessary, including an estimated 11 percent of all procedures. What’s more, 70 percent of the responding doctors said that they believed profit was a driving factor. “The best way to lower health-care costs in America is to stop doing things we don’t need,” Marty Makary, a professor at Johns Hopkins School of Public Health and a co-author of the Plos One study, told me. Some medical institutions—Kaiser Permanente and the Mayo Clinic among them—no longer link physician pay to the quantity of procedures performed for this reason.

Unlike prescription drugs or medical devices, which are regulated by the FDA, the tens of millions of surgical procedures performed in the U.S. each year are not subject to direct government oversight. “To be fair to physicians, everything around surgery is regulated,” Jonathan Darrow, an assistant professor at Harvard Medical School, told me. “But they don’t tell you what to do on a surgery-by-surgery basis.” Darrow has published two recent papers on lack of surgical oversight, in the Cornell Journal of Law and Public Policy and The American Surgeon. “What concerns me is that I think patients don’t understand how lightly regulated surgery is, and, more important than that, how little evidence there is that could clarify what outcomes they might expect.”

Take arthroscopic partial meniscectomy, the surgery to repair a torn meniscus. The procedure has long been one of the most-performed surgeries in the world, despite a lack of clinical evidence to support its effectiveness. In fact, about 10 years ago, clinical trials showed that patients who’d had the surgery had no statistical difference in improvement versus those who’d only been told that they’d had the operation. Most people were better off with a combination of exercise and physical therapy. Nevertheless, surgeons continue to repair roughly 700,000 torn menisci each year. The same is true in the case of spinal fusions for back pain: Research has shown nonoperative treatments to be just as effective. Still, spinal-fusion rates continue to climb.

The explanation for the surfeit of those procedures, according to Philip Stahel, the chief medical officer at the Medical Center of Aurora, in Colorado, is at least partly cultural. “Surgeons operate because they’re trained to do surgery,” Stahel told me. And, he said, consumer culture plays a role in leading many people who walk into a doctor’s office to expect surgery. Stahel acknowledges other explanations too. “We are incentivized to perform surgical procedures either for financial gain, renown, or both,” he told me. The hospitals that employ the surgeons also have a financial incentive. During the coronavirus pandemic, American hospitals lost an estimated $22.3 billion in 2020 revenue from delaying elected surgeries so staff could treat people who had COVID-19. Surgeons also tend to associate volume with status. “I would rather tell you I did 10,000 procedures than say I did a couple,” Stahel said. Patients like volume too. Given the choice, most people would prefer to have surgery performed by a doctor who’s done an operation thousands of times as opposed to someone who’s completed only a handful.

When doctors do perform an inappropriate procedure, the options for holding them accountable shift to a morass of individual hospitals, professional-conduct groups, and state medical boards. Makary calls it a “Bermuda Triangle of blame.” “The state medical boards will say it’s the professional societies. The professional societies, when you ask them, will say it’s the hospitals. And the hospital department heads say it’s the state medical boards,” he said.

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The legal system acts as a final backstop. Most of the False Claims Act cases filed each year are health-care related, including cases concerning unnecessary surgeries. In 2020, the government recovered $2.2 billion in fraud and abuse via the False Claims Act, $1.8 billion of which was health-care related. Payouts for medical-malpractice claims in the U.S. hover around $4 billion each year.

Although the law provides a route for the federal government to recoup costs, it cannot undo the procedures. In recent years, more than 100 of Sorensen’s patients have elected to reverse their PFO closure. At least one person, who was in her early 60s, died in the operating room at St. Mark’s hospital because of complications. Her family has brought a lawsuit against the hospital and the doctors who operated on her. Sorensen is not a party in the case.

On consecutive Thursdays in summer 2020, Sorensen answered questions during daylong depositions related to the False Claims Act case filed in 2012. (Through his attorney, Sorensen declined to be interviewed for this story, citing pending litigation.) For years, the case had ping-ponged between various jurisdictions and courts. A Utah federal district judge initially dismissed the case, but the Tenth Circuit Court of Appeals later reinstated it, finding that “at a minimum, the amended complaint adequately alleges that St. Mark’s and Intermountain acted with reckless disregard as to whether the PFO closures Dr. Sorensen was performing were medically necessary.”

Soon after the Tenth Circuit court ruled, Intermountain and St. Mark’s settled. Intermountain agreed to pay the government $8 million. In settling, Intermountain did not admit any liability and denied all of the allegations. In a statement, the hospital said that after Michaels, the University of Utah cardiologist, raised his concerns, a lengthy peer review “culminated in the issuance of Intermountain PFO Closure Guidelines in 2011, which we believe were the first such guidelines … issued by any hospital in the country. Dr. Sorensen did not agree with the guidelines and that disagreement led, ultimately, to Dr. Sorensen’s resignation. Significantly, the Intermountain PFO Closure Guidelines have been in place for a decade and are consistent with standard of care.”

St. Mark’s, where Sorensen performed far fewer procedures, settled last year for $1.6 million, also denying the lawsuit’s allegations and not admitting any liability. A spokesperson for the hospital said that Sorensen was recognized as a skilled interventional cardiologist and that his medical license was in good standing while he was on staff.

On April 9, 2021, Sorensen Cardiovascular Group agreed to settle the federal civil case for an undisclosed amount.

As the whistleblower, Polukoff received a portion of all three settlements. (Whistleblowers typically get 15 to 30 percent of the money recovered.) He continued to work as a cardiologist at Intermountain until December 2019. When I asked him how he felt now that the case had come to an end after nine years, Polukoff told me that for long stretches, he wondered why so many excellent physicians never objected to what Sorensen was doing. “Eventually you just shrug your shoulders and think, It’s because that’s the way it is,” Polukoff said. “It was so pervasive and benefited so many. This was about exploitation and how easy it is to get away with it. Still, I don’t want people walking away thinking there’s no role for PFO closure. There is a role, but it’s rare, for select individuals.”

Former patients, including Simmons, have filed 1,200 malpractice lawsuits against Sorensen, some of which also include St. Marks, in Utah state court. The first trial was anticipated to begin in spring 2021, but COVID-19 restrictions at the courts have pushed the date back to next year. “Dr. Sorensen probably has more cases pending against him than any doctor in America,” Polukoff’s attorney, Rand Nolen, told me. Hundreds of Sorensen’s patients likely still do not know that serious questions have been raised about his PFO practice. In fact, according to court records, Sorensen may have performed as many as 8,000 total closures during his career, billed to both the government and private insurers.

In court filings, Sorensen has denied the allegations against him, including that he inappropriately billed Medicare and Medicaid and that on two occasions he created a PFO in patients he was operating on. One of Sorensen’s lawyers, Peter Striba, told me in an email that “in 2017 and 2018 randomized clinical trials, started 10 years before, showed that closure was superior to medication management … [They] established what countless doctors across the country believed; closure was superior to medication as the optimal treatment for PFOs in certain patients.”

Read: Lies, damned lies, and medical science

Indeed, in 2017 The New England Journal of Medicine published research showing that in patients who’d experienced a cryptogenic stroke, the risk of having another stroke was lower in patients who received the closure procedure compared with patients who received medication. Recent guidelines for PFO closure, released in 2020 by the American Academy of Neurology, state, “Clinicians should counsel patients that … it is difficult to determine with certainty whether their PFO caused their stroke; and that PFO closure probably reduces recurrent stroke risk in select patients.” However, this information was not published when Sorensen was practicing, and even still it would likely not account for the high volume of procedures he performed.

Reading through Sorensen’s depositions, he comes across at times as both defensive and defiant. He goes so far as to suggest that research is superfluous—that PFO closure was obviously the superior treatment for his patients. At one point, a plaintiff’s lawyer referred to a PowerPoint lecture of Sorensen’s that included a slide with a cartoon on it. The cartoon depicted a doctor and a patient with an arrow sticking out of his temple. The caption read: “Off hand, I’d say you’re suffering from an arrow through your head. But just to play it safe we’ll need to wait for more studies.”

What was Sorensen’s motivation? Money? A portion of his income was contingent on the number of procedures he performed. A single PFO closure can generate $15,000 in charges; conservatively, in the 10 years Sorensen was doing the procedure, that’s at least $40 million. Prestige? Sorensen’s reputation as a top PFO practitioner spread not just around Utah but across the country. Or maybe it was something akin to altruism, however perverse. Nancy Futrell, one of the doctors who was critical of Sorensen, told me, “He thought what he was doing was good for people.”

Just before the new year, Simmons and her husband had their first child, a boy they named Walter, after Simmons’s late grandfather. Although Sorensen had used the possibility that she might die in childbirth to persuade Simmons to have her PFO closed, it was her health complications caused by her reaction to the closure device that forced her to delay starting a family. “I can’t believe this went on for so long,” Simmons told me. “It’s reassuring to know you’re not the only one, but in this case that makes it even worse.” Like Simmons, many of Sorensen’s patients also said that after their surgery, he told them that they’d had the largest hole in their heart he’d ever seen.

A few years ago, Simmons and her husband traveled to San Diego to visit one of her high-school friends. One morning, they went out to breakfast, and the conversation turned toward how Simmons had sought therapy and found it helpful. Her friend asked about why she’d started going; Simmons explained the whole saga of her PFO. As soon as Simmons mentioned PFO closure, her friend perked up. She said she knew two people back in Utah who’d had the same operation. Simmons asked if she remembered who the doctor was who’d performed the surgeries. Sure enough, it was Sorensen.