St. Joseph should review additional Midei cases

December 12, 2010|By Jay Hancock

Compassionate care for everybody is St. Joseph Medical Center's mission. You can decide whether the hospital's decision to suppress its own finding that its patients suffered "substantial likelihood of harm" is compassionate.

Last year, a committee of St. Joseph doctors determined that Dr. Mark Midei implanted cardiac stents in dozens of cases where they weren't needed, resulting in "the substantial likelihood of harm to his patients" and "the potential for serious complications," according to an internal document published in a Senate Finance Committee report last week.

Stents prop open clogged heart arteries, but St. Joseph found that Midei was installing them in vessels with insignificant blockage.

An independent expert panel ultimately found that Midei put potentially unneeded stents in 585 patients over two years and a few months. But the hospital changed the message when it told patients.

"A subsequent clinical review of your cardiac catheterization report was different than the original report and may be relevant to your ongoing care and treatment," said a typical letter, which urged patients to see their outside cardiologists.

Nothing about harm or complications. Patients had to figure out what happened. Maybe they played 20 questions. Was the "subsequent review" different because it had a prettier typeface?

St. Joseph sent "all pertinent information" to the patient's doctors, the hospital said in response to my query. Those outside physicians could interpret the review for stent recipients, it said. But perhaps, when a house of healing reaches such grave conclusions about the treatment of patients within its walls, it has a duty to tell them.

At least those folks got some notice, however encrypted. Thousands received stents from Midei before the two-year period St. Joseph chose to investigate. But there is no need to review those cases because "the risk of clotting, and perhaps any complication, is greatly diminished, and is in the realm of 1 percent to 2 percent after two years," Ellen Barton, a St. Joseph vice president, wrote in September in The Baltimore Sun.

St. Joseph seems to value independent expert panels. So I assembled one, asking five of the country's top bioethicists and cardiologists whether the hospital made the right decision on the earlier cases.

"I can't see any reason why it would be defensible to limit the review of cases to the two previous years," said Robert M. Veatch, professor of medical ethics and former director of the Kennedy Institute of Ethics, both at Georgetown University. "At least from a moral point of view, I can think of all sorts of reasons why patients who had their procedures more than two years ago would want to know."

St. Joseph employed Midei starting in early 2008, but he installed cardiac stents there for years before that. He is the only cardiologist whose procedures the hospital has flagged.

"If the patients had a procedure performed that was not medically indicated, they have a right to know that," said Dr. Robert D. Truog, director of clinical ethics at Harvard Medical School. "I think they should go back as far as necessary to inform patients of that."

St. Joseph's internal report said that the risk of thrombosis, or potentially deadly blood clots, "increases to 2.4 percent three years following the intervention" — longer than two years. Some doctors believe stent patients should take an expensive anti-clotting drug for life.

"I've seen very late stent thrombosis occur more than five years out," said Dr. William E. Boden, a professor at the University of Buffalo Schools of Medicine and Public Health, chief of cardiology at two Buffalo hospitals and the leader of a major study on stent effectiveness. "If the interest here is for the hospital to come clean and do a thorough, deep dive into all suspected cases of inappropriate stent usage, why would they restrict this to the period of time from 2007 forward? It's not a logical argument."

Midei has repeatedly denied wrongdoing. Midei lawyer Stephen L Snyder says St. Joseph sacrificed him on trumped-up charges to fend off a federal investigation of alleged kickbacks to cardiologists.

Dr. David Holmes, president-elect of the American College of Cardiology and an interventional cardiologist at the Mayo Clinic, said he wasn't familiar enough with the St. Joseph case to make a recommendation in that instance. However, he said: "As an investigator, as a scientific interventional cardiologist, which I hope we all are, I think full disclosure of data is really important so it can be looked at critically, analyzed in the light of day [so] lessons can be learned from it."

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