A Chicago surgeon is being sued after implanting a device which he invented in a patient, allegedly without consent. The device, a Myxo ETlogix annuloplasty ring, was implanted in the patient in April 2006 by Dr. Patrick McCarthy at Northwestern Memorial Hospital to fix the patient’s leaky heart valve. Dr. McCarthy developed the heart device and receives royalties for its sale, which are donated to a charity. In July, a research paper by Dr. McCarthy was published in a medical journal. The article was based on a study that included the patient and focused on the initial experience with the device. Dr. McCarthy stated that the patient had consented to participate in the study. The patient said that she would not have consented to the use of an experimental device. The doctor denies that the device was experimental but failed to inform the patient that he had invented the ring before proceeding with the implantation. According to medical ethics experts, a patient should be informed if a surgeon will receive royalties on a device that he or she may use in surgery and a patient must agree to take part in medical research, by signing an informed consent form his or her to their involvement in the study.
The patient experienced inflammation following the implantation, was required to undergo a second surgery to remove the device, and is now confronted with the possibility of needing a heart transplant. She filed a lawsuit in Cook County this April against McCarthy, Northwestern Memorial Hospital and Edwards Lifesciences, the device’s manufacturer.
The FDA has received 10 reports on adverse events related to the Myxo ETlogix ring and an investigation is currently underway to determine whether the agency received proper notice about the device.
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