Illinois Patient Sues Chicago Surgeon for Medical Malpractice Over Injuries and Failure to Obtain Informed Consent
A woman who may have to go a heart transplant after a new heart device was implanted inside her during surgery is suing prominent Chicago Dr. Patrick McCarthy for medical malpractice. McCarthy implanted the device, a Myxo ETlogix ring, in the body of Toni Vlahoulis during a surgery to repair a leaky heart valve in 2006. McCarthy did not, however, tell her that he was the inventor of the new device.
Vlahoulis, who experienced inflammation after the surgery, had to undergo a second surgery to have the device removed. She says that if she had known the device was experimental, she never would have agreed to have it placed inside her.
McCarthy denies that the device was experimental because an older model was available commercially over a month before he performed the surgery on the 41-year-old patient. Northwest Memorial Hospital claims it obtained the necessary consent from Vlahoulis for the implant procedure.
Vlahoulis, who filed her Illinois personal injury lawsuit in Cook County earlier this year, is seeking over $50,000 in damages from McCarthy, device manufacturer Edwards Lifesciences, and Northwestern Memorial Hospital.
McCarthy says that he doesn’t believe that the ring is the cause of Vlahoulis’s latest health issues. The Chicago doctor is a consultant for Edwards Lifesciences and he receives royalties for the three heart devices he invented. He donates the royalties to the Greater Chicago Food Depository.
According to medical ethics experts, surgeons should inform patients if royalties will be generated from any devices used in surgeries. Patients are also supposed to sign a consent form noting their agreement to take part in any medical research.
The US Food and Drug Administration is looking at whether it obtained proper notice regarding the Myxo ETlogix rings. McCarthy says he and his partners have implanted nearly 200 devices. He says that he only uses the device if it is the best fit for a patient. The FDA has received 10 reports complaining about adverse effects occurring after the device was implanted.
Failure to Obtain Informed Consent
Physicians, dentists, surgeons, and other medical provider must obtain a patient’s informed consent before conducting a procedure. An “informed consent” form notes any potential complications and risks that could arise from the treatment or procedure. The medical provider should also discuss the potential risks with the patient prior to the procedure.
If injury or death arises from a procedure in which a patient did not give his or her informed consent, the medical provider could be held liable for medical malpractice or wrongful death.
Patient sues over Chicago surgeon's new device, CNN.com, October 15, 2008
Questions raised about Northwestern use of valve device; prominent surgeon denies wrongdoing, TheHeart.org, October 7, 2008
Northwestern Memorial Hospital
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