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Mother Dies Amid Abuses in $110 Billion U.S. Stent Assembly Line

Najam Azmat snaked a catheter on a guide wire into Judi Gary’s groin as he tried to insert a stent in an artery supplying blood to her pelvis and right leg.

On an X-ray monitor near where Gary lay, nurses saw blood leakages. The wire seemed to be in the wrong place, nurse Evan Gourley told Azmat. Everything was fine, the vascular surgeon replied. It wasn’t.

Azmat tore Gary’s aorta during the December 2005 procedure, according to documents filed with a U.S. Justice Department civil complaint. Nurses asked another surgeon to step in. Gourley left in disgust. Later, he went to administrators at Satilla Regional Medical Center in Waycross, Georgia, with a warning about Azmat.

“I told them that he will kill a patient if they let him continue to work,” Gourley said. Officials at the Satilla hospital got at least seven similar warnings about Azmat, according to another nurse’s notes.

They let him continue. One of his next patients died.

Azmat’s tenure at the 231-bed hospital, as described in interviews and more than 1,000 pages of medical records, internal documents and witness statements that were made public last year, shows the extremes one hospital went to in order to keep its catheterization clinic -- or “cath lab” -- operating and producing revenue.

Other hospitals paid millions in kickbacks -- using ghost jobs, padded fees, debt forgiveness or discounted office space -- to induce doctors to keep up the pace in U.S. medicine’s binge on stents, according to allegations made in five federal cases and three other private whistle-blower lawsuits.

Needless Stents

Stents, metal mesh devices that prop open clogged blood vessels, have been implanted via catheters in seven million heart patients over the last decade -- perhaps as many as one-third of them needlessly, according to David Brown, a cardiologist at Stony Brook University School of Medicine in New York. In all, 11 hospitals have agreed to settlements with the Justice Department, resolving civil allegations of needless stenting and related wrongdoing.

Most of these federal lawsuits, typically filed by whistle-blowers under seal, have slowly been made public since 2009. They, along with dozens of interviews with patients and doctors, reveal that hospitals benefited financially while overlooking -- or even encouraging -- allegedly inappropriate stent use.

At Satilla, Azmat punctured the wall of Ruth Minter’s right kidney while trying to insert a stent in an artery near the organ in January 2006. She died 17 days later of complications from heavy blood loss, the federal complaint said. The procedure “was not medically indicated,” according to a Justice Department expert’s report.

No Lifesavers

“People who should have and could have saved Mrs. Minter’s life were too interested in having Dr. Azmat continue to do procedures and make money for the hospital to do the right thing,” said surgeon Harold Kent, who reviewed Minter’s care for a lawsuit her family filed against the doctor and the hospital.

Satilla officials denied that they kept Azmat on the job in order to make money for the hospital’s cath lab, and said his services were both needed and valuable to patients.

“The number one concern of Satilla and the administration was patient safety,” said Joseph P. Griffith Jr., an attorney who represented the hospital and its chief administrator.

The hospital agreed to pay $840,000 to resolve the Justice Department’s complaint that it submitted claims for cath-lab services -- some of them unnecessary -- that Azmat was neither qualified nor properly credentialed to perform. The hospital admitted no wrongdoing.

Azmat declined to be interviewed for this story. He denied in court filings that he caused the death of Ruth Minter.

‘Boiler Room’

The flood of money poured into cardiac stents -- at least $110 billion for procedures over the last decade -- can lead to “corrupted practices,” said William Hsiao, a health-care economist at Harvard University.

Cardiovascular services, including stents, open-heart surgery and other procedures, can account for as much as 40 percent of net revenues in many hospitals, said Vikas Saini, president of the Lown Institute, a neighboring Brookline, Massachusetts-based group that works to extend health care to needy people and limit unnecessary treatments.

“The cath lab is like a boiler room -- the place that makes everything else go” in a hospital, said Saini, a cardiologist. “Hospital administrators will tell you that they don’t make the medical decisions, they don’t decide who gets a stent … ‘It’s our doctors who do that.’ But they have no incentive to scrutinize the behavior and appropriateness of what the doctors are doing. They have every incentive to look the other way.”

Peripheral Growth

Cath labs and similar facilities will generate about $20 billion in billings this year as cardiologists and other specialists evaluate and treat about 4 million patients’ arteries, veins and valves via the long plastic tubes, said Brian Contos, executive director of research for the Advisory Board Company, a health-care consulting group.

Few dispute the benefits of coronary stents when they’re used to restore blood flow in heart-attack patients. Since 2007, when a national study found that coronary stents added no benefit over medicines, exercise and dietary improvements for stable heart patients, their use has declined. Last year, sales of the devices fell 5 percent to $5.5 billion. Meanwhile, sales of so-called peripheral stents, used to increase blood flow in vessels that serve such areas as the legs or kidneys, has increased -- by 8 percent last year to $2.1 billion, according to Health Research International, an industry consultant.

No-Show Jobs

Still, as of 2011, coronary stent procedures were being performed at 1,653 sites in the U.S., Contos said -- up 58 percent from 1998.

In seeking to keep their labs bustling, some hospitals offered cardiologists no-show jobs, according to federal lawsuits.

In Erie, Pennsylvania, Tullio Emanuele said he had just started working as a cardiologist for a group called Medicor Associates in 2001, when his new boss asked him to become a medical director at Hamot Medical Center under a $75,000-a-year contract. Emanuele, a native of Italy who attended medical school in Rome, said he found the post had few responsibilities.

“My duties were just a few hours a month preparing for a meeting,” he said in an interview. He suspected something was wrong when a Medicor clerk asked him to sign timesheets that were already filled out and inflated his hospital hours, he said.

Whistle-Blower Complaint

His “sham” contract was just one of several between Hamot and Medicor that Emanuele says were designed to induce a steady stream of patients for the hospital’s cath lab, according to a whistle-blower complaint he filed under the federal False Claims Act last November. The law gives people the right to seek to recover money on behalf of the U.S. government in cases of overpayment. The Justice Department has declined to join Emanuele’s complaint, which is pending in federal court.

Emanuele, who worked for Medicor until 2005, said he found cases in which stents were inserted in patients without significant heart disease. One, identified in his complaint only as A.R., died of complications from a needless cardiac catheterization in 2004, according to his lawsuit.

Officials for Hamot, which was purchased in 2011 by the University of Pittsburgh Medical Center, declined to comment, spokeswoman Caroline Manino said. Neal Devlin, an attorney for Medicor, also declined to comment.

In legal filings, Medicor said its medical directorships at Hamot were “legitimate and legal” and denied that any of its physicians accepted kickbacks or performed unneeded procedures. Hamot denied paying kickbacks or engaging in any unlawful relationships with physicians to induce patient referrals.

‘Recycling Patients’

The cardiologists at EMH Regional Medical Center in Elyria, Ohio, built their heart business by ‘recycling patients’ -- that is, doing repeated procedures, including stents, on the same patients in the hospital’s cath lab -- according to a whistle-blower lawsuit filed by Abdul Wattar, a cardiologist, and unsealed in January.

“I’ve seen patients with an astonishing number of stents that I hadn’t heard before, sometimes exceeding 20 stents,” Wattar said in a deposition. From 2004 to 2009, he worked with a practice called the North Ohio Heart Center, which pressured him and others to refer patients to EMH’s cath lab, he said.

In January, the hospital and the cardiology group agreed to pay the U.S. $4.4 million to settle allegations that they billed Medicare for unnecessary stents from 2001 to 2006. Both deny wrongdoing and say they acted within established practice. EMH has fewer inappropriate stent cases than the average hospital, said Stephen Sozio, an attorney who represented the hospital in the federal lawsuit.

Best Decisions

“The plaintiff’s allegations in these cases had no merit,” said John Schaeffer, the president of North Ohio Heart, in an e-mailed statement. “We made the best medical decisions available then, and we continue to do that now.”

“It was like an assembly line,” said Geraldine Koehler, whose mother, Margarette Kerrigan, was a repeat patient. Kerrigan, 77, died of massive internal bleeding 10 hours after North Ohio Heart’s leading cardiologist, Charles O’Shaughnessy, inserted two stents in 2003, an autopsy report and medical records show. O’Shaughnessy declined to comment, said Gary Zrimec, North Ohio Heart’s chief executive officer.

In another whistle-blower suit unsealed in January, Kenny Loughner, the former manager of EMH’s cath lab, said he saw O’Shaughnessy and another North Ohio Heart doctor “routinely instruct EMH nurses and technicians involved in the procedures to record fictitious and non-existent complaints of chest pain” or falsify heart-monitoring records to justify needless operations.

‘Completely Unreliable’

An expert hired by the U.S. Attorney’s Office independently determined that “false statements” were recorded in some medical records to justify procedures, according to a memo from the U.S. Department of Health and Human Services’ Office of Inspector General.

Sozio, the hospital’s lawyer, called the expert’s finding “completely unreliable” and said it was “never raised in our discussions with the government.”

In 2005, the hospital opened a new cath lab that was marketed as “North Ohio Heart Center at EMH,” according to Loughner’s complaint. Tax records show 51 percent of the lab’s profit went to EMH and 49 percent to the cardiology group. The two merged in 2010.

‘Rarely Attended’

Loughner’s lawsuit accused the heart group of receiving kickbacks from EMH’s cath-lab budget and an extra $5,000 a month paid to O’Shaughnessy “under the pretense” that the payments were for his service as director of the cath lab.

“O’Shaughnessy rarely attended the committee meetings he was being paid to chair,” Loughner’s lawsuit says.

The kickback allegations aren’t true, said Sozio, the hospital’s lawyer. “There has never been any finding that any laws were broken, and in fact none were,” said Schaeffer, North Ohio Heart’s president.

The Justice Department joined the portion of Loughner’s lawsuit accusing the hospital and the doctors of unneeded stenting, and didn’t mention kickbacks or false records in the settlement agreement. Loughner received $660,859 of the $4.4 million settlement in the case. Wattar’s complaint was dismissed in January.

Doctors Needed

Satilla Regional Medical Center had a problem. In the fall of 2004, two cardiologists decided not to renew their exclusive contract with the hospital, according to the federal complaint. They were taking their patients elsewhere, and now the hospital needed to replace them, said Gregory Uhl, the former director of Satilla’s cath lab.

“They wanted to keep the cath lab busy,” he said in an interview.

It’s not easy to attract top doctors to Waycross, Georgia, about 240 miles southeast of Atlanta and perched at the edge of the 700-square-mile Okefenokee Swamp. Like many rural hospitals, Satilla has to pay “higher than average physician compensation due to pressures to recruit to the area,” according to a 2011 report prepared for Georgia’s attorney general.

Robert Trimm, the hospital’s chief executive officer, was already negotiating with a surgeon; he’d drafted a $350,000 salary proposal for Najam Azmat in May 2004, court records show, before the talks stalled. About a year later, Satilla went back to Azmat, with a guaranteed salary of $600,000 in his first year.

‘Full Spectrum’

A father of four married three times, Azmat arrived in the U.S. in 1983 after graduating from Khyber Medical College in Peshawar, Pakistan. He completed a surgical residency in New York and then joined the staff of Hardin Memorial Hospital in Elizabethtown, Kentucky, in 1996. By 2004, he’d left that post and was seeking a new one.

When he expressed interest in setting up his practice in Waycross, Azmat e-mailed that his goal was to build a “full spectrum” of vascular services -- including those involving work inside blood vessels, such as inserting peripheral stents, he said in a deposition filed last year in federal court.

When he applied, his only hands-on training in stents consisted of two weekend courses practicing on cadavers and pigs, Azmat said later. In June 2005, just before he joined Satilla’s staff, Azmat said he attended a two-day class in Louisiana where he implanted at least two stents in the renal arteries of live humans.

Credentials Questioned

Two months later, Satilla’s credentialing committee granted Azmat vascular surgery privileges. In its lawsuit, the Justice Department alleged that Azmat’s credentials didn’t cover stents.

While the three-page credentialing document doesn’t mention stents specifically, it says, “Privileges include, but are not limited to, insertion and management of arterial catheters.” In a legal filing, the hospital said Azmat’s privileges covered all the procedures he performed at Satilla.

Azmat was soon working steadily in the lab -- and almost from the start, nurses said they had doubts about him. When they scrubbed in with him, they noticed he didn’t know which catheters to use or how to thread them, former cath-lab nurses Evan Gourley and Lana Rogers said in depositions.

“He was very, very aggressive and rough,” Rogers said in her 2010 deposition. After her second case with Azmat, Rogers went to see Harmon Raulerson, then-manager of Satilla’s Heart Center. CEO Trimm was also present.

‘Teach Him’

“It’s completely obvious that he’s not been trained to do these procedures,” she told them, according to her deposition.

“Well, teach him,” Raulerson replied, according to Rogers’s testimony. Rogers and other nurses weren’t trained in stents either, she said. Raulerson referred questions to Clay Thomas, a hospital spokesman, who declined to comment.

During Azmat’s first stent operation, a cath-lab equipment salesman looked on, telling the doctor how to use the stents, sheaths, wires and balloons, Rogers testified.

In October 2005, Azmat found a blocked artery in the left leg of Allan G. Flower, a retired construction foreman. Then he inserted a stent in Flower’s healthy right leg, Tony Preston Smith, a Duke University professor of radiology, wrote in an affidavit.

The procedure was unnecessary and dangerous, wrote Smith, who was hired as a litigation expert by some of Azmat’s former patients. Azmat placed the device behind Flower’s knee, which is flexed so often that the metal stent could cause a blood clot requiring emergency surgery, Smith said. Flower died last year of lung cancer.

Four Tries

Norman Wayne Copeland went to the cath lab three times to get a leg stent without success. First, Azmat said the hospital had run out of stents and had to order another box, Copeland said in an interview. Days later, on Nov. 2, 2005, Azmat tore an artery supplying blood to Copeland’s left leg, medical records show. Azmat said he couldn’t insert the stent because of a “kink” in Copeland’s blood vessels. A third try failed too.

A fourth procedure successfully implanted the stent. Yet the type of operation Azmat performed was overly complex and medically unnecessary -- and the stent was too large for his artery, Smith’s report said.

The oversized device put strain on the vessel wall and could cause trauma leading to blockage, according to a medical review by Joseph Stavas, a radiologist at the University of North Carolina at Chapel Hill who examined Azmat’s cases for the Justice Department.

Two Amputations

“It’s caused me a hell of a lot of pain,” Copeland said, rubbing his thigh as he sat in a rocking chair.

Lucille Peterson, a diabetic for 30 years, had gangrene in the toes of her right foot. In November 2005, Azmat told her stents would increase her blood flow, said her daughter, Elizabeth. During the procedure, he perforated an artery, the government’s expert report said.

Both legs were amputated afterward, Elizabeth said. There was “very little to no gain in circulation and the procedure is not medically indicated,” the government’s expert report said. Satilla billed Medicare $21,015.65 and collected $16,104.21 for Peterson’s care. She died last year at 91.

Nurses’ complaints to managers began to snowball. By Thanksgiving, four nurses had individually taken their concerns to various administrators, including Trimm, the CEO, according to witness statements.

‘Revenue Source’

Uhl, the cath lab director, testified he had a couple of “curbside” discussions with Azmat about his performance. He also spoke to Trimm and the hospital’s chief operations officer, Windell Smith, several times about Azmat, he said, and told Trimm he didn’t think the surgeon’s credentials allowed for stents.

“Nothing was done because of the money Dr. Azmat was generating for the cath lab,” Uhl said in an interview. “They saw him as a revenue source to do procedures.”

Smith and Trimm didn’t respond to messages requesting comment. In a deposition, Trimm said that he followed up on each of the nurses’ complaints and said he didn’t ignore any red flags. He talked to Azmat, checked in with subordinates to make sure they were dealing with concerns and questioned other physicians at Satilla about Azmat’s performance, he said. They told him they were unaware of any problems, Trimm said.

“I will always in these types of matters, when you’re questioning a physician’s training, defer to a physician to give me guidance on how to handle that situation or to evaluate that situation,” he said.

Possible Cuts

Just after Christmas 2005, Raulerson, the heart center’s manager, wrote a memo about possible job cuts -- two nurses, one tech and one registration clerk -- if the cath lab didn’t make enough money.

“I expect Dr. Azmat’s procedure volume to continue to increase,” said the memo, which is filed as an exhibit in the federal case against Satilla. “I will continue to monitor staffing and make recommendations.”

The next day, Azmat tried to implant a stent in an artery in Judi Gary’s pelvis. He tore her aorta, according to the government’s complaint -- and prompted what Uhl called “a total revolt” in the cath lab. Nurses threatened to boycott Azmat’s procedures, according to Uhl and nurses Rogers and Gourley.

Azmat voluntarily agreed to stop installing stents, Uhl said. Nurses decided to stay on the job.

‘Basically Steamrolled’

That resolution lasted only 10 days before nurses noticed that Azmat was scheduled to insert a stent in a patient’s renal artery on Jan. 12, 2006. When they went to Raulerson for an explanation, he said that “powers higher than within this department” had made the call, according to notes kept by nurse Marci Johnson. The typed notes were later entered as exhibits in state and federal lawsuits.

Uhl said he felt “completely ignored and basically steamrolled.”

Suspending Azmat’s privileges “was not in Satilla’s financial interest,” the Justice Department said in a 65-page civil fraud complaint that was filed in 2010 and settled last year. The hospital ran an ad in local newspapers touting his work in the cath lab: “Dr. Azmat keeps things running smoothly,” the ad said. “For example, your blood.”

Ruth Minter paid the highest price. A mother of five, she loved tending to her flower garden, according to court records. She’d been having back and stomach pain, and Azmat recommended a procedure to examine her kidneys and possibly insert a stent to improve blood flow to them, her medical records show.

Punctured Kidney

During her operation, Azmat ran a guide wire into the artery. He extended it so far that it penetrated the wall of her right kidney, a medical review found. Minter started bleeding -- though Azmat said in a deposition that he couldn’t tell that from the images he was seeing during the procedure.

Afterward, Azmat approached Minter’s family and told them he had placed the stent successfully, her family’s lawsuit says. They weren’t reassured. They saw nurses scurrying in and out of her room with bloody linens, they said in written responses to questions in the court file. Minter complained of severe stomach pain.

That night, she was airlifted 80 miles to Baptist Medical Center in Jacksonville, Florida, where she had emergency surgery to stop the internal bleeding caused by the kidney perforation, according to the federal complaint.

Minter died of hemorrhagic shock and multiple organ failure 17 days after her operation, the complaint said. Her stent procedure “was not medically indicated,” the Justice Department’s expert said later. Satilla collected a $10,872.56 Medicaid reimbursement for the procedure.

‘Worthless’ Care

Federal investigators found more than 30 patients who received “worthless,” poor or unnecessary care from Azmat, according to experts’ case reviews and other documents filed in federal court. Azmat denied providing substandard or unneeded care and accused the government of withholding medical records from expert witnesses.

Satilla was engaged in “Russian roulette being played with federal health care program patients,” Department of Justice trial attorney Arthur Di Dio said during a court hearing. The hospital’s administrators knew Azmat wasn’t qualified, yet allowed him to keep working, “profiting all along the way with the lucrative hospital service claims it received in connection with those procedures,” Di Dio said.

After Minter’s procedure, Azmat agreed to suspend his work in the cath lab, and Satilla agreed not to report any adverse actions regarding him to a national data bank or to Georgia regulators. A copy of the confidential agreement, dated Feb. 14, 2006, was filed last year in federal court.

Insurance Dropped

In August 2007, Azmat resigned from the hospital after getting notice that his malpractice insurance was being dropped, he said in a deposition.

Minter’s family and seven others sued Azmat, Trimm and other administrators, along with Satilla, alleging negligence and fraud among other counts. All were resolved without trial. Records from Georgia’s state medical board, which reports settlement amounts only above certain thresholds, show three medical malpractice payments by Azmat’s insurer in 2011 and 2012 totaling $2,025,000.

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Nurse Lana Rogers filed a federal whistle-blower complaint, which the Justice Department later joined. In an April 2010, news release that responded to the Justice Department, Satilla called Rogers a “disgruntled ex-employee” and said it was being targeted by malpractice lawyers and federal officials hoping for “a payday.” When the hospital’s $840,000 settlement was announced in January 2012, Rogers received $189,501 of the total.

Medicare Exclusion

The HHS Office of Inspector General excluded Azmat from participating in Medicare and other federal health insurance programs in May 2012, records show. He failed to meet appropriate standards of care for six patients, the office told him in an earlier letter. The Justice Department dropped its civil case against him in July 2012.

Azmat, who still has a house in Waycross, referred questions to his lawyers. Attorneys Thomas Withers and Christopher Ray declined to comment. Attorney Adam Ferrell didn’t return e-mails or telephone calls seeking comment.

The Satilla hospital became part of the Mayo Clinic Health System last year. Trimm, who stayed on as chief administrative officer, left last month for a job with the Studer Group, a health care consulting firm.

After leaving Satilla, Azmat worked at pain clinics. In Lexington, Kentucky, he made $7,500 a week writing prescriptions for narcotic painkillers, though he had little formal training in pain management, according to the Kentucky Board of Medical Licensure.

U.S. marshals arrested him in February on charges that he operated a pill mill with five other people in Garden City, Georgia. He pleaded not guilty and is awaiting trial. As a condition of his $100,000 bond, he agreed not to practice medicine.

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