The definition of informed consent for surgery may be expanded as a result of a law suit filed recently in the United States. In the future, doctors my need to tell patients if they have a financial stake in the treatment being given, beyond the usual fees for their medical services.
In fact, ethicists are saying they should disclose such information already.
The issue stems from a law suit filed by a Chicago woman who is suing a leading heart surgeon there after he implanted a device in her heart to repair a valve. The patient, 41-year-old Toni Vlahoulis, said she never would have agreed to the surgery had she known her doctor invented the device meant to keep her valve from leaking, and received royalties every time one is used.
The doctor -- Patrick McCarthy -- says he donates all the royalties to charity. The device, called a Myxo ETlogix ring, eventually had to be removed after causing an infection.
Dr. William Maisel, director of the non-profit Medical Device Safety Center at Boston's Beth Israel Deaconess Medical Center, said patients have a right to know when a doctor is using one of his own inventions.
"It's not hard to tell a patient, 'You may be receiving a device for which the physician receives royalties.' ... Then the patient may say, 'I'm not comfortable with that. Pick one of the other devices.'"
Donating the royalties changes nothing, Maisel said, since use of the device and research published as a result of its use would increase a doctor's status in the profession.
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