They lost their legs. Doctors and health care giants profited

Kelly Hanna’s leg was amputated in 2020, after a Michigan doctor who called himself the “leg saver” had damaged her arteries by snaking metal wires through them to clear away plaque.

It started with a festering wound on her left foot. Her podiatrist referred Hanna to Dr. Jihad Mustapha. Over 18 months, he performed at least that many artery-opening procedures on Hanna’s legs, telling her they would improve blood flow and prevent amputations.

They didn’t — for Hanna or many of his other patients. Surgeons at nearby hospitals had seen so many of his patients with amputations and other problems that they complained to Michigan’s medical board about his conduct.

Mustapha is no back-alley operator working in the shadows of the medical establishment, an investigation by The New York Times has found. With the financial backing of medical device manufacturers, he has become a leader of a booming cottage industry that peddles risky procedures to millions of Americans — enriching doctors and device companies and sometimes costing patients their limbs.

The industry targets the roughly 12 million Americans with peripheral artery disease, in which plaque — a sticky slurry of fat, calcium and other materials — accumulates in the arteries of the legs. For a tiny portion of patients, the plaque can choke off blood flow, leading to amputations or death.

But more than a decade of medical research has shown that the vast majority of people with peripheral artery disease have mild or no symptoms and don’t require treatment, aside from getting more exercise and taking medication. Experts said even those who do have severe symptoms, like Hanna, shouldn’t undergo repeated procedures in a short period of time.

Some doctors insert metal stents or nylon balloons to push plaque to the sides of arteries. Others perform atherectomies, in which a wire armed with a tiny blade or laser is deployed inside arteries to blast away plaque. Rigorous medical research has found that atherectomies are especially risky: Patients with peripheral artery disease who undergo the procedures are more likely to have amputations than those who do not.

The volume of these vascular procedures has been surging. The use of atherectomies, in particular, has soared — by one measure, more than doubling in the past decade, according to a Times analysis of Medicare payment data.

There are two reasons. First, the government changed how it pays doctors for these procedures. In 2008, Medicare created incentives for doctors to perform all sorts of procedures outside hospitals, part of an effort to curb medical costs. A few years later, it began paying doctors for outpatient atherectomies, transforming the procedure into a surefire moneymaker. Doctors rushed to capitalize on the opportunity by opening their own outpatient clinics, where by 2021, they were billing $10,000 or more per atherectomy.

The second reason: Companies that make equipment for vascular procedures pumped resources into a fledgling field of medicine to build a lucrative market.

When doctors open their own vascular clinics, major players like Abbott Laboratories and Boston Scientific are there to help with training and billing tips. Electronics giant Philips works with a finance company to offer loans for equipment and dangles discounts to clinics that do more procedures.

Mustapha declined to comment on Hanna’s case, citing health care privacy law. But he strongly defended his treatment of the seriously ill patients who form the bulk of his practice. He said his clinics have “very low” rates of complications, including 1.3% of patients having “major amputations” within 30 days of treatment.

“The vast majority of the patients we serve have had exceptional outcomes,” Mustapha said. “We have saved countless limbs — and lives.”

Representatives of Philips, Abbott and Boston Scientific stood by their work with outpatient clinics, which they said cut costs and were better for patients. A Philips spokesperson said it was standard practice across industries to provide loans to finance large purchases.

The vascular industry faces minimal regulation. Many medical devices sail through the Food and Drug Administration’s clearance process without much data showing they work. The clinics are not subject to the same safety regulations as hospitals. Even when regulators determine that doctors have performed unnecessary procedures, they generally impose paltry fines and let them continue practicing.

Fifteen surgeons told the Times they were frequently called in to fix problems caused by doctors in vascular clinics.

“Someone who cuts or inserts something into a patient for unnecessary work is the same as someone stabbing you in the street and taking your wallet,” said Dr. Russell Samson, a vascular surgeon in Florida.

Millions in payments

From 2017 to 2021, about half of Medicare’s atherectomy payments — $1.4 billion — have gone to 200 high-volume providers, the Times analysis found.

Many of the doctors who do the most vascular procedures receive payments — for consulting, speeches and other services — from the device industry that profits from their work.

For example, the top provider of Medicare-financed atherectomies in Louisiana, Dr. David Allie, received $2.8 million from drug and device makers between 2013, when the federal government began collecting such data, and 2022. He didn’t respond to requests for comment.

In addition to those payments, device companies have lent money to 153 of the 200 doctors or their clinics to finance the purchase of medical equipment, according to a Times review of loan filings.

At least one company, Philips, allows doctors to reduce or eliminate their monthly payments if they use the company’s equipment to perform a minimum number of procedures, according to current and former Philips employees.

The Philips spokesperson, Ken Peters, said the loans are issued by Philips Medical Capital, which Philips owns with a finance company. He said Philips Medical Capital made independent decisions about which doctors get loans.

Assembly line

Of the 200 doctors who performed the most atherectomies, Mustapha stands out — both for the harm that patients and doctors say he has caused and for the support he has received from the device industry.

Mustapha’s website said he performed his first “limb-salvage treatment” more than a dozen years ago, “preventing the amputation of the leg of a 52-year-old woman.” Of all of his professional titles, the website says, he is proudest of “the Leg Saver.”

In 2018, he and his nephew, Dr. Fadi Saab, opened their first vascular clinic in Grand Rapids, Mich. Later that year, they opened another in Lansing, Mich. The business was called Advanced Cardiac & Vascular Centers for Amputation Prevention.

From 2013 to 2017, while Mustapha worked for Metro Health Hospital in Grand Rapids, he performed 358 atherectomies. In the next four years, he billed Medicare for more than 1,500. Saab billed the agency for 1,150 more.

Those atherectomies earned their clinics nearly $18 million from Medicare alone. That doesn’t include any procedures covered by private insurance.

Mustapha’s clinics at times felt like an assembly line, according to three former employees who requested anonymity because they still work in health care. Sometimes, they said, he performed procedures on two patients simultaneously.

Mustapha said that “procedures are scheduled with enough time so patients can be treated safely, kindly and respectfully.”

Rushed to the hospital

In March 2020, an ambulance rushed Cheryl McAdams to a hospital from Mustapha’s Grand Rapids clinic, where he was performing his seventh procedure on her in two years. A device he was using broke off in her leg, causing internal bleeding, medical records show.

At the hospital, a vascular surgeon performed emergency surgery. He later filed a complaint about Mustapha with Michigan’s medical licensing board, and McAdams, 74, sued. Mustapha has denied the claims.

Seven other surgeons said in interviews that they had been called in to treat dozens of patients who had been harmed by Mustapha.

One was Hanna, 62. She arrived at McLaren Greater Lansing Hospital in July 2020, after 18 months of treatment by Mustapha.

Her right foot was purple and cold to the touch. A vascular surgeon at the hospital, Dr. Judith Lin, said in an interview that she had no choice but to amputate above the knee.

By then, Lin had already treated several of Mustapha’s former patients. Some required amputations. Others needed leftover wires extracted from their legs. Like McAdams’ surgeon, Lin complained to Michigan’s licensing board.

Mustapha questioned Lin’s expertise but declined to comment on what she said about his patients. He also raised the possibility of Lin having competing interests, because Michigan State University, her employer, is opening a vascular clinic in Lansing. Lin said that had nothing to do with her complaints, which long predated the new clinic.

Starting in 2020, the medical licensing board investigated her complaint and referred it to Michigan’s attorney general, who brought disciplinary action against Mustapha. An expert hired by the state to review eight patient cases concluded that his practice “was characterized by overtreatment and poor documentation.” The expert found that in some cases, including Hanna’s, unnecessary procedures hastened amputations.

The state’s expert also cited the case of Traves Louch as another example of someone who underwent “a concerning number” of unnecessary procedures — four in less than three weeks.

After the last one, blood stopped flowing to Louch’s left foot. Ten days later, his lower leg was amputated.

“What the signs say on his offices is to prevent and help prevent amputations,” said Louch, 50. “And here I am with half my leg gone.”

Mustapha declined to comment on individual patients.

In April, he reached a settlement with the Michigan attorney general, agreeing to pay $25,000 and to take medical education courses. He did not acknowledge wrongdoing.

Mustapha said the state could have imposed a tougher punishment and the fact that it didn’t “speaks for itself.” He also said that members of the medical board lacked his experience in treating patients with advanced peripheral artery disease.

Mustapha referred the Times to a handful of patients who raved about his treatment. Two said in interviews that Mustapha saved their limbs.

Another said he began seeing Mustapha at his doctor’s advice, even though he had no pain in his legs and was physically active. The man said Mustapha had been performing procedures on him for 14 years. In 2021, his lower leg was amputated.

This story was originally published at nytimes.com. Read it here.

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