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Chicago Medical Malpractice Lawsuit Accuses Cardiac Surgeon of Putting Wrong Device in Patient?s Heart Valve

A woman who says that a well-known surgeon at Northwestern Memorial Hospital placed the wrong device in her heart valve has filed a Chicago, Illinois medical malpractice complaint. Toni Vlahoulis says that before undergoing open-heart surgery for a leaky valve, she was never informed that the Myxo Etlogix Ring, which was inserted into her heart, was not FDA approved.

She says that she thought another mitro valve ring was going to be used instead of the one that her cardiac surgeon, Dr. Patrick McCarthy had invented. Vlahoulis said it was never her intention to be used as a guinea pig for the device.

Since McCarthy performed the heart surgery, Vlahoulis has undergone another one to have the ring taken out. While the Chicago injury plaintiff isn?t saying that the medical device was defective or malfunctioned, she is claiming that she did not give her consent to have the experimental ring placed in her body.

The Chicago hospital and McCarthy disagree with Vlahoulis?s accusations that the Myxo Ring is an experimental device. The ring?s manufacturer, Edwards Lifesciences, says that it followed the FDA guidelines.

McCarthy performed over 150 surgeries using the ring before the FDA asked its manufacturer to pull the device from the market. Last year, the agency cleared the device under a different name.

Currently, a medical device doesn?t need FDA approval if it is only a little different from medical devices that already been approved. Manufacturers are the ones to determine whether any difference is enough to require approval.

Informed Consent
A doctor performing a medical procedure must obtain the patient?s informed consent. In addition to getting the patient?s permission to do the procedure, the doctor must explain the kind of treatment or procedure that is going to take place, any possible risks or benefits, whether there are alternative treatments and what they are, and what might happen if the patient decides not to undergo the procedure/treatment.

Lawsuit Claims Surgeon Inserted Wrong Device Into Woman?s Heart Valve, MyFOXChicago, March 10, 2010

Informed Consent, American Medical Association

FDA clears Myxo ETlogix valve ring under new name but disagrees with earlier decision by Edwards that device did not need 510(k), The Heart.org

Related Web Resources:
Edwards Lifesciences

US Food and Drug Administration

Full post as published by Chicago Injury Attorney Blog on March 11, 2010 (boomark / email).