Dr. Nalini Rajamanna, a cardiologist and former employee of Northwestern Memorial Hospital, has made a complaint with the Graduate Medical Education Accreditation Council on behalf of many patients that she feels were wronged. Rajamanna is now Medical Director and Cardiologist at Most Sacred Heart of Jesus Cardiology and Valvular Institute in Sheboygan, Wisconsin. T
he complaint says that 667 patients of her former employer were subjected to heart valves that were part of an experiment. She says that these actions violated the U.S. accreditation standards and demonstrated medical malpractice. Northwestern has responded by saying the accusations are false and meritless. Further, they contend that Rajamanna has been making such allegations for years and no court or regulator has concurred; in fact, a related jury verdict even was in the hospital’s favor.
More than 10 years ago Maureen Obermeier underwent an open heart surgical procedure at Northwest and she says that she has been tired and unable to clearly think ever since. She says that Dr. Patrick McCarthy, the hospital’s head of cardiac surgery, implanted a device into her heart without consenting with her that led to her having a heart attack during the procedure. She claims that the device was “experimental and investigational” and that McCarthy never discussed his intentions of using the device that he invented in her visits prior to surgery. The jury in Cook County in 2016 entered a finding in favor of McCarthy and Northwest regarding the insertion of the Myxo Ring, a heart valve device. Northwestern maintains that they adhered to proper procedures in obtaining informed consent.
The purpose of the Myxo Ring is for treatment of myxomatous disease which is a degeneration of the heart’s mitral valve. Ms. Obermeier’s suit alleged a failure in informed consent and also medical battery. The claim explained that McCarthy had inserted Myxo Ring Model 5100 while still actively consulting with the manufacturer, Edwards Lifesciences, regarding several key factors including sizing, tools to use etc. For several years the rebranded Myxo ETlogix 5100 ring was investigated by the U.S. Senate after others also claimed they were not informed of the experimental nature of the device or that the surgeon conducting the procedure was the device inventor.
Ultimately, neither the Cook County jury nor other investigations found the allegations to be true. Northwestern University and Northwestern Memorial Hospital both indicated that the matter has been concluded and that no further inquiries were underway. Northwestern stated that an expert witness for the plaintiff in the case found no wrongdoing associated with the ring’s selection or implementation technique.
McCarthy insisted that he had been assured that the device was allowed for usage by the U.S. Food & Drug Administration at the time. With the Graduate Medical Education Accreditation Council receiving this new complaint, an investigation is likely. Although the prior claims did not prevail, the Digital Journal feels that this claim will differ in how it will cite that the FDA inadequately processed reviewing the device.