Patient Sues Heart Surgeon for Unauthorized Implantation of Experimental DeviceOct 16, 2008 | Parker Waichman LLP
The Associated Press (AP) is reporting on a prominent Chicago surgeon earning royalties on a new heart device he implanted in a 41-year-old woman without her consent; this, according to a lawsuit filed by patient Toni Vlahoulis. Dr. Patrick McCarthy claims he donates the royalties to charity.
Vlahoulis underwent a second surgery to remove the device because of inflammation and may require a 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. McCarthy denies the device was experimental. Vlahoulis claims McCarthy neglected to inform her he invented the device before the surgery to repair a leaky heart valve in April 2006. Vlahous’ negligence lawsuit, filed in April 2008, seeks over $50,000 in damages from McCarthy; Chicago's Northwestern Memorial Hospital; and Irvine, California-based device manufacturer Edwards Lifesciences.
The AP reports that McCarthy, the hospital, and officials from the manufacturer all argue that the device was not experimental because “it was commercially available more than a month before Vlahoulis' surgery” and that it was a “slightly modified version of one previously available.” The hospital maintains it obtained “appropriate consents for the procedure.” McCarthy also claims that he and his partners have implanted "close to 200" of the devices, which are called Myxo ETlogix rings, with no problems and does not feel Vlahoulis' reactions were a result of the ring, which he says was made of similar materials as a previous model and was just "a little bigger" and "a different shape."
The AP also noted that McCarthy is a consultant for the device maker and that the royalties he receives for three heart devices he developed are donated to the Greater Chicago Food Depository. This case is a clear example of the “close business ties between some heart surgeons and device manufacturers,” said the AP. TheHeart.Org, a Website for cardiologists that is owned by WebMD, first reported the case and its related ethical issues.
"It's not hard to tell a patient, 'You may be receiving a device for which the physician receives royalties,'" said Maisel, former chair of the U.S. Food and Drug Administration's (FDA) 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 that he's not persuaded it becomes ethical in McCarthy's case because he donated his royalties, said the AP. "It's not just about the money," said Maisel, who pointed out that making product innovations and publishing research on results increases a doctor's “prominence in the profession.”
According to medical ethics experts, surgeons should inform their patients if they will receive royalties on a device they may use in surgery. Similarly, patients who are involved in medical research must be told and must agree to take part in such research by signing an "informed consent" form. Meanwhile, the FDA—which has received 10 reports of adverse events related to McCarthy’s design—is investigating whether it received proper notice about the device, said agency spokeswoman Peper Long.