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Dec-27-2011 16:10printcomments

Northwestern U. Dismissed Medical Professor Who Questioned Cardiac-Surgery Chief's Safety Record

The controversy centers on a heart-valve device, known as the Myxo ring...

Nalini M. Rajamannan, an associate professor of medicine at Northwestern U., says she was dismissed after producing evidence that cast doubt on an assertion in an article by the university's chief of cardiac surgery.
Nalini M. Rajamannan, an associate professor of medicine at Northwestern U., says she was dismissed after producing evidence that cast doubt on an assertion in an article by the university's chief of cardiac surgery. Photo by Anna Knott

(CHICAGO) - Northwestern University has fired an accomplished heart doctor after she produced evidence suggesting its chief of cardiac surgery won federal approval of an implant invention by making a false claim about its safety.

The dismissal of Nalini M. Rajamannan, an associate professor of medicine, is the most drastic step to date in a four-year battle by Northwestern to defend the cardiac surgeon, Patrick M. McCarthy, against accusations in two lawsuits that he experimented on patients without their knowledge and hid evidence to help his device win a safety approval.

Northwestern had already stripped Dr. Rajamannan of her clinical privileges and denied her tenure. It finally removed her on September 30, even though she still has federal research grant money, after she reported having discovered a record of a patient's electrocardiogram that appeared to undercut Dr. McCarthy's key published assertion that no recipients of his invention had suffered a heart attack.

"When I brought the EKG data to them," Dr. Rajamannan said, "they fired me."

A spokesman for Northwestern, however, says that there was no retaliation against Dr. Rajamannan and that her dismissal was a straightforward result of the fact that she was denied tenure. "She was under consideration for tenure, and the customary and clearly defined procedures, including peer review, were followed," said Alan K. Cubbage, Northwestern's vice president for university relations. "There was no retaliation by Northwestern University against Dr. Rajamannan."

The controversy centers on a heart-valve device, known as the Myxo ring, that was invented by Dr. McCarthy and is manufactured by Edwards Lifesciences, a California company that specializes in artificial heart valves. Dr. Rajamannan and the two lawsuits, filed by patients of hers, suggest that Dr. McCarthy, a star in his field worth millions of dollars to his university, may have worked with Edwards to routinely test innovations on unsuspecting human subjects.

Dispute Over Outcomes

The Myxo ring helps hold together leaky heart valves in patients with a condition known as myxomatous degeneration, in which the valve weakens, sometimes leading to heart failure. The controversy over the Myxo ring developed in large part because of a policy by the federal Food and Drug Administration that allows manufacturers of an approved medical device to make what they consider to be minor modifications without seeking new regulatory approval.

The Myxo ring is one of several close variants of another ring device that had already won FDA approval, and thousands of patients have had a Myxo ring or one of the other variants sewn into their hearts since 2000. Dr. Rajamannan contends those implants have been associated with more than 4,000 adverse outcomes, including more than 600 deaths—a sharply higher figure than the several hundred negative outcomes associated with the FDA-approved ring.

Edwards and Dr. McCarthy were forced by the FDA to stop implanting the Myxo ring in 2008 after Dr. Rajamannan complained that one of her patients, following a 2006 implant surgery performed by Dr. McCarthy, discovered that the device hadn't been specifically approved by the FDA.

The patient, Antonitsa Vlahoulis, has said that her problem with shortness of breath worsened after the operation, and that she was surprised to learn afterward that she received a Myxo ring and that it wasn't explicitly approved by the FDA.

A spokeswoman for Edwards Lifesciences, Sarah Huoh, said the company had made a good-faith attempt to apply the authority the FDA gives companies to assess whether a device is significantly similar to an existing approved device. "Occasionally, the FDA reviews a manufacturer's decision and disagrees, and this is what took place," Ms. Huoh said.

But Dr. Rajamannan, a research collaborator with Dr. McCarthy at Northwestern Memorial Hospital in Chicago, their university's primary teaching hospital, says she saw evidence of intentional deception, including the failure of Dr. McCarthy to explain the situation to the patients. Also, Dr. Rajamannan said, the Myxo ring has a different shape and contains different materials than does the FDA-approved device. In particular, said Dr. Rajamannan, who treated Ms. Vlahoulis before and after her surgery, the Myxo ring contains more silicone than the FDA-approved device. "That was the problem for Vlahoulis, because she had a silicone allergy," Dr. Rajamannan said.

FDA Approval

The dispute led Edwards Lifesciences to seek specific approval of the Myxo ring and another similar device it manufactures. Dr. McCarthy led the ensuing safety study. His findings, published in 2008 by The Journal of Thoracic and Cardiovascular Surgery, reported that he had implanted the Myxo ring in 100 patients with no significant problems, including no heart attacks. The FDA, citing that study, granted its approval of the Myxo ring.

But another patient of Dr. Rajamannan, Maureen Obermeier, also filed suit, claiming her heart-valve condition also worsened after she received the Myxo ring in a surgery performed by Dr. McCarthy. Ms. Obermeier's lawyer asked the hospital for her medical records, and was given a set with no documentation of an electrocardiogram from the day of her implant surgery in November 2006. The hospital later produced the electrocardiogram results, showing an apparent heart attack in the hour after Ms. Obermeier's surgery, but it did so only after Dr. Rajamannan combed through Ms. Obermeier's files and discovered she had been billed for the test. And then, in an affidavit for the Obermeier lawsuit submitted just two months ago, Dr. McCarthy acknowledged that the electrocardiogram showed Ms. Obermeier had suffered a heart attack shortly after the surgery.

Dr. McCarthy, in a written response to questions from The Chronicle, said some patients given the Myxo ring were excluded from his study's summary of results because they had other medical conditions that could have caused a heart attack. Although that condition of the study was not noted in the journal article's summary, the article does describe the exclusion of patients with conditions that include rheumatic valve disease. And Ms. Obermeier's records show she had a childhood history of rheumatic fever.

But, Dr. Rajamannan said in an interview, if Ms. Obermeier's rheumatic scarring made her ineligible for consideration in the study, she should have also been ineligible for the Myxo ring. "If he thinks that she had rheumatic-valve disease, then she never met criteria from the moment he opened up her chest wall," she said. There is an existing FDA-approved ring for patients with that combination of conditions, she said.

Dr. McCarthy, in his written exchange with The Chronicle, declined to respond to that point. He instead suggested that his track record of performing 10,000 operations over his career made him better qualified to make medical judgments than a junior colleague who has been disciplined by her university and has failed to convince the FDA and other agencies that he did anything wrong.

"I would have absolutely no motive to do an experimental trial without patient consent, and I never have," Dr. McCarthy said.

Dr. Rajamannan disputes Northwestern's denials of retaliation against her. She argues that Dr. McCarthy's value to the university is financial, saying he performs more than 100 surgeries a year in cases that each produce about $100,000 in total revenue for the hospital and university.

Northwestern hired Dr. McCarthy in 2004 from the Cleveland Clinic, where he spent 14 years marked by a series of heart device patents as well as a controversy in which he and other doctors accepted a financial interest in a company, AtriCure Inc., that produced equipment for a procedure they used on patients.

Upon his arrival at Northwestern, Dr. McCarthy appeared to work well with Dr. Rajamannan. AChicago magazine profile in 2007 featured them together as two of the city's top doctors. On her own, Dr. Rajamannan has won at least 15 awards and scholarships, including honors sponsored by thethe the National Institutes of Health and the American Heart Association.

A former president of the American Heart Association, Robert O. Bonow, was one of the first people Dr. Rajamannan said she contacted when Ms. Vlahoulis complained that she had gotten an experimental implant without her knowledge. Dr. Bonow, then chief of cardiology at Northwestern's hospital and the medical school, recommended that she not pursue the matter, Dr. Rajamannan said. "His comment was, 'You don't cross Pat McCarthy,' and, 'We're going to separate you, so don't pursue this.'"

Dr. Bonow, asked to confirm whether he had made such a comment to Dr. Rajamannan, provided a written response in which he said he did not want to answer without first consulting his lawyer.

This article was published in the October 10, 2011 issue of The Chronicle of Higher Education.

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