The charge relates to Dr. McCarthy using a device called the Myxo Ring, which is a device McCarthy invented. The charge, misreported in some media as one of ‘human experimentation’, is one of malpractice (the alleged experimentation was addressed and settled by the FDA.) The issue relates to the use of a cardiovascular device. The intention of the device is to treat degenerative myxomatous disease, which affects the mitral valve of the heart.
The case been brought by Maureen Obermeier. Obermeier alleges that McCarthy about 10 years ago inserted a Myxo Ring mitral valve device into her heart without her giving consent. She further states that the incident resulted in a heart attack and other complications. The heart attack occurred in 2006. The use of the devices, the case indicates, was not confined to the one patient.
At the time of the incident, McCarthy was a cardiac surgeon at Northwestern University’s teaching hospital. The legal action extends to Northwestern Memorial Hospital and the Northwestern Medical Faculty Foundation.
According to Fox 32, Obermeier’s attorney Adrwin Boyer commented: “He was putting it into patients, seeing how it worked, and not telling them.”
However, according to a statement from Northwestern, provided to Digital Journal that there were “clear protocols and processes in place to ensure patients are properly informed that the device is being chosen and implanted as part of a clinical trial.”
The medical center also adds: “the plaintiff’s own expert witnesses testified he had no criticisms of the ring, the selection of the ring, or the surgical technique used by Dr. McCarthy.”
McCarthy’s defense, according to the website QMed, is that although the devices were used in approximately 100 patients between 2006 and 2007, both he and Northwestern Memorial Hospital had received assurances that the use of the devices was permitted under U.S. Food and Drug Administration (FDA) rules.
However, alternative information was later received from FDA. Here Northwestern told Digital Journal that it “took concerns raised regarding the Myxo Ring very seriously. All patients who had received the Myxo Ring at NMH at that time were notified and later updated on the FDA review.”
The outcome will be interesting. While previous complaints against NMH and Dr. McCarthy on this issue have been dismissed, the conclusion could question the robustness of the FDA review process.
