December 5, 2010
Doctor Faces Suits Over Cardiac Stents
By GARDINER HARRIS
Word quickly reached top executives at Abbott Laboratories that a Baltimore cardiologist, Dr. Mark Midei, had inserted 30 of the company’s cardiac stents in a single day in August 2008, “which is the biggest day I remember hearing about,” an executive wrote in a celebratory e-mail.

Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home, according to a report being released Monday by the Senate. The dinner was just a small part of the millions in salary and perks showered on Dr. Midei for putting more stents in more patients than almost any other cardiologist in Baltimore.

The Senate Finance Committee, which oversees Medicare, started investigating Dr. Midei in February after a series of articles in The Baltimore Sun said that Dr. Midei at St. Joseph Medical Center, in Towson, Md., had inserted stents in patients who did not need them, reaping high reimbursements from Medicare and private insurance.

The senators solicited 10,000 documents from Abbott and St. Joseph. Their report, provided in advance to The New York Times, concludes that Dr. Midei “may have implanted 585 stents which were medically unnecessary” from 2007 to 2009. Medicare paid $3.8 million of the $6.6 million charged for those procedures.

The report also describes the close relationship between Dr. Midei and Abbott Labs, which paid consulting fees to the cardiologist after he left the hospital. “The serious allegations lodged against Dr. Midei regarding the medically unnecessary implantation of cardiac stents did not appear to deter Abbott’s interest in assisting him,” the report states.

The case has turned into a legal quagmire for Dr. Midei and St. Joseph, which have been sued by hundreds of patients who claim they received unnecessary implants. Some doctors say the case has revealed a level of inappropriate care that is more common than most patients know.

“What was going on in Baltimore is going on right now in every city in America,” said Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who said he routinely treats patients who have been given multiple unneeded stents. “We’re spending a fortune as a country on procedures that people don’t need.”

Dr. Midei’s lawyer, Stephen L. Snyder, said that his client’s treatment of his patients was entirely appropriate and that Dr. Midei, who has recently practiced medicine at the Prince Salman Heart Center in Saudi Arabia, would be exonerated.

“This is all trumped up to hide the hospital’s criminal conduct,” said Mr. Snyder, who filed a $60 million lawsuit against St. Joseph on Dr. Midei’s behalf accusing the hospital of damaging Dr. Midei’s reputation by making false claims about his care. (The hospital responded that the assessments of Dr. Midei’s care were done by independent experts.)

Last month, St. Joseph agreed to pay a $22 million fine to settle charges that it paid illegal kickbacks to Dr. Midei’s medical practice, MidAtlantic Cardiovascular Associates, in exchange for patient referrals; the hospital did not admit wrongdoing. St. Joseph said in a statement Friday that it now conducts monthly random reviews of stent cases “to assure such a situation cannot occur again.”

As for Abbott Labs, a spokesman wrote in an e-mail that its affiliation with Dr. Midei ended early this year. “Dr. Midei has been a highly regarded physician in his field, with whom Abbott had consulted in the past,” said the spokesman, Jonathan Hamilton. “We have no further comment at this time.”

The case has had wide repercussions. Over the past year, St. Joseph has told hundreds of Dr. Midei’s patients that they did not need the expensive and potentially dangerous stents that the doctor inserted because their arteries were not as obstructed as he had claimed. Now, state health officials are investigating other local cardiologists who inserted a suspiciously high number of stents, which are tiny wire mesh devices inserted to prop open clogged arteries in the heart.

After reports about the Midei case and the wider state investigation, the number of stent procedures performed at St. Joseph and other area hospitals plunged, raising doubts about the appropriateness of much of the region’s cardiac care.

A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them. Dr. Christopher J. White, president-elect of the Society for Cardiovascular Angiography and Interventions, said that inappropriate stenting was a problem, but a rare one. The federal Medicare program spent $3.5 billion last year on stent procedures.

Prosecutors, malpractice lawyers and state medical boards are only now waking up to the issue. The Texas Medical Board last month accused a widely known cardiologist in Austin of inserting unnecessary stents. In September, federal prosecutors accused a cardiologist in Salisbury, Md., of performing unnecessary stent surgeries, and last year a Louisiana doctor was sentenced to 10 years in prison for inserting unneeded stents.

J. Stephen Simms, a Baltimore lawyer who successfully pursued a federal whistle-blower lawsuit involving kickbacks for coronary procedures, said such cases were “the flavor of the month right now” with federal prosecutors.

Jay Miller, another Baltimore lawyer, said he was devoting his entire practice to unnecessary stent cases. “And I don’t think this is limited to just a few Maryland hospitals,” Mr. Miller said.

But far from questioning cardiologists who perform an unusually high number of stent procedures, many hospital executives celebrate these doctors because of the revenue they bring, which can be more than $10,000 per procedure.

“Hospital patients expect their care to be based on medical need, not profits,” said Senator Max Baucus, Democrat of Montana and chairman of the Finance Committee. “Even more disconcerting is that this could be a sign of a larger national trend of wasteful medical device use.”

Dr. Midei’s fall was as rapid as it was dramatic. In a June deposition for a lawsuit against him, he said: “I didn’t know what hit me. I was bewildered by what had happened.”

He had been one of the most sought-after clinicians in his region. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore’s private hospitals. Dr. Midei was one of the practice’s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment.

St. Joseph was so concerned about losing Dr. Midei’s business that the hospital offered a $1.2 million salary if he would leave MidAtlantic and join the hospital’s staff. When Dr. Midei agreed, the merger with Union collapsed, MidAtlantic sued, and the practice’s former chief executive vowed in a deposition to “spend the rest of my life trying to destroy him personally and professionally.”

In the June deposition, Dr. Midei estimated that in 2005 — before research revealed that many stents were unnecessary — he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories ranked Dr. Midei’s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph’s size.

That sort of increase in volume was an obvious red flag, said Dr. William E. Boden, clinical chief of the division of cardiovascular medicine at the University of Buffalo and an author of the 2007 stent study. “For him to have this brisk increase over those years is really unusual,” Dr. Boden said.

In stable patients, stents should be used only if X-rays show that most of the artery is blocked, and the patient has symptoms like frequent chest pain. Stent procedures can, in rare cases, cause bleeding, stroke or a heart attack. Once a stent is placed, it can result in a life-threatening clot that emerges weeks to months later. Stent patients must spend a year or more taking blood-thinning medications, which have their own risks.

In April 2009, a patient of Dr. Midei’s who was also a St. Joseph employee complained that he had received an unneeded stent and that many other patients had as well. The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that 585 patients might have received unnecessary stents.

When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed, including from patients treated well before January 2007.

Abbott responded to the controversy by hiring Dr. Midei as a consultant. “It’s the right thing to do because he helped us so many times over the years,” an Abbott executive wrote in a January e-mail cited in the Senate report.

The company sent Dr. Midei to Japan, but news of the controversy made his duties impossible, and he flew home. After one particularly critical story in The Baltimore Sun, David C. Pacitti, an Abbott executive, wrote in an e-mail, “Someone needs to take this writer out and kick his ass!”

Edward Chaid, 68, a semiretired general contractor from Timonium, Md., is among those who have sued. Five years ago, Mr. Chaid decided to get his first physical examination in decades. Just to be safe, his doctor sent him for a cardiac stress test at MidAtlantic, which revealed a small “squiggle” of concern, Mr. Chaid said. He was sent to Dr. Midei to get his arteries X-rayed, and he emerged from the procedure with two stents.

“Dr. Midei said: ‘You sure are lucky. You had 90 percent blockage.’ And the nurse said, ‘Oh yeah, you were blocked in your widow-maker.’ And I said: ‘Thank God. I guess I’m really lucky you got it when you did,’ ” Mr. Chaid said in an interview.

Five years later, another doctor concluded that Mr. Chaid’s blockage had been minimal. “I was really shocked,” Mr. Chaid said. “I’m from a generation where doctors are thought very highly of.”

But Mr. Snyder, Dr. Midei’s lawyer, said that his client’s care had been entirely appropriate, that doctors often interpret X-rays differently and that St. Joseph was using him as a scapegoat. A Web site created by friends of Dr. Midei lists dozens of testimonials like this one: “Plain and simple, Dr. Midei saved my life.”

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