Patient sues over Chicago surgeon's new device

A leading Chicago surgeon who earns royalties on a new heart device used it in a 41-year-old woman without her consent, according to a lawsuit filed by the patient. At least one expert observer calls that unethical, even though the surgeon says he donates the money to charity.

Toni Vlahoulis of Niles needed a second surgery to remove the device because of inflammation and now faces a possible heart transplant, Vlahoulis claims and her cardiologist confirmed.

"There's no way I would have consented to putting an experimental device in my body," Vlahoulis said.

Dr. Patrick McCarthy, who denies the device was experimental, didn't inform Vlahoulis he had invented the device before implanting it in her body to fix a leaky heart valve in April 2006, Vlahoulis said.

Her negligence lawsuit, filed in April of this year in Cook County, seeks more than $50,000 in damages from McCarthy, Chicago's Northwestern Memorial Hospital and Irvine, Calif.-based device manufacturer Edwards Lifesciences.

It also highlights the close business ties between some heart surgeons and device manufacturers.

"There are many good people who do research and move the field forward, and the relationship between physicians and the industry is critical, particularly for medical devices," said Dr. William Maisel, director of the nonprofit Medical Device Safety Institute at Boston's Beth Israel Deaconess Medical Center. "Certainly there has been a lot of public concern and backlash about those relationships."

McCarthy, the hospital and officials from the manufacturer contend the device was not experimental because it was commercially available more than a month before Vlahoulis' surgery, and it was a slightly modified version of one previously available. The hospital maintains it obtained appropriate consents for the procedure.

McCarthy said he and his partners have implanted "close to 200" of the devices, called Myxo ETlogix rings, without problems. He doesn't believe Vlahoulis' troubles were caused by the ring because it was made of similar materials as a previous model and was just "a little bigger" and "a different shape."

McCarthy, a consultant for the device maker, said the royalties he gets for three heart devices he's developed are donated to the Greater Chicago Food Depository. He collects $30 to $50 per device, totaling $5,000 to $7,000 a year, he said.

The case and surrounding ethical issues were first reported by TheHeart.Org, a Web site for cardiologists owned by WebMD.

Medical ethics experts say surgeons should inform their patients if they will receive royalties on a device they may use in surgery. Patients involved in medical research also must be told and agree to take part by signing an "informed consent" form.

"It's not hard to tell a patient, 'You may be receiving a device for which the physician receives royalties,'" said Maisel, who also is former chair of the U.S. Food and Drug Administration's Circulatory System Devices Panel. "Then the patient may say, 'I'm not comfortable with that. Pick one of the other devices.'"

Maisel called it unethical to keep such information from patients and said he's not persuaded it becomes ethical in McCarthy's case because the surgeon gives away his royalties.

"It's not just about the money," said Maisel, who noted that making product innovations and publishing research on the results add to a doctor's prominence in the profession.

Northwestern Hospital spokeswoman Holli Salls declined to discuss the issue of informed consent because it is part of the lawsuit, but said "the idea that Dr. McCarthy used this device for any academic gain is ludicrous," noting that McCarthy already has written 300 papers and two books related to the heart and heart disease.

McCarthy published a research paper in a July medical journal on "initial experience with a new ring" about the device used in Vlahoulis. She was one of the patients in that study, McCarthy said, and had consented to participate when she agreed to be part of a database of surgical outcomes.

Dr. Nalini Marie Rajamannan of Northwestern University Feinberg School of Medicine, who referred Vlahoulis to the surgeon, said she withdrew her name from the research paper after learning her patient never consented to receive a device Rajamannan understood was experimental.

"In March 2006, we were informed by Dr. McCarthy that he was starting a trial for the Myxo ring. We were told by Dr. McCarthy in various Northwestern Valve Center Meetings that the device was being implanted only at Northwestern in 2006 as a single center use," Rajamannan said in an e-mail.

"I assumed that Dr. McCarthy was obtaining informed consent from all of the patients getting the ring," she said.

The FDA is investigating whether it received proper notice about the device, said agency spokeswoman Peper Long. The agency has received 10 reports on adverse events related to McCarthy's design, according to the FDA's Web site.

McCarthy, who does 400 heart surgeries a year, said he always chooses the best device for the needs of each patient, regardless of his involvement in its design. He finds it ironic that his status as an innovator has drawn criticism.

"Patients typically come to me because I do so much of this, because I am an inventor," McCarthy said. "There is only one of the patients that has had a bad result, in our experience and to our knowledge across the board, and I don't think it's related to the ring."