Northwestern Memorial Hospital and Star CV Surgeon Found Not Guilty in Myxo Ring Case


(UPDATED)
The jury in a long-running suit that pitted a former patient against Northwestern Memorial Hospital and its star cardiothoracic surgeon, Patrick McCarthy, MD, over the implantation of a mitral annuloplasty ring has reached a verdict. The charges brought by the patient related to informed consent and medical battery have no merit, the jury decided.

As previously reported by TCTMD, Maureen Obermeier alleged that the ring invented by McCarthy, known as the “Myxo,” was an experimental device she never consented to receive and that it caused an ST-elevation MI during implantation and led to the subsequent development of heart failure and her needing an implantable cardioverter-defibrillator.

The manufacturer of the device, Edwards Lifesciences, had originally been named in Obermeier’s lawsuit but summary judgement by a judge earlier this year, in favor of Edwards, released the manufacturer from the case.

According to Obermeier’s suit, McCarthy implanted the Myxo ring, Model 5100 as part of a clinical study of patients without informing them or obtaining consent, all the while still consulting with Edwards on sizing strategies, necessary tools, surgical techniques, and “other key aspects of the ring system.” Obermeier also alleged that her MI was caused by a surgical stitch that occluded the circumflex artery, potentially related to the larger dimensions of the Myxo ring used.

Obermeier’s case has been limping through the courts since 2009.

McCarthy has always acknowledged that he invented the ring—although he has previously admitted that he did not mention this to his patients—and, with Northwestern Memorial, has always insisted that the device was not experimental at the time he used it in patients, since the manufacturer had given assurances that the device was already cleared for market use. Originally, the Myxo entered the market via a regulatory loop-hole wherein devices could be marketed via paperwork describing minor modifications to already cleared products. In the case of the Myxo, the US Food and Drug Administration (FDA) ultimately disagreed with the manufacturer’s choice of regulatory pathway—leading to a new 510(k) submission to the FDA. The agency ultimately cleared the Myxo more than 2 years after its first use and has since revised its guidance as to clarify requirements as to when new 510(k) applications are needed for medical devices.

Nalini Rajamanan, MD, the cardiologist who first blew the whistle on what she believed to be inappropriate use of an experimental device—leading to several US Senate investigations and an FDA rebuke—told reporters in an emailed statement that she is “not surprised” by the verdict. She believes, however, that documents made public as a result of the 8 years’ worth of discovery in the Obermeier case will allow greater scrutiny of how the device was used and altered in the early years of its use.

A spokesperson for Northwestern Medicine and Northwestern Memorial Hospital, Christopher King, said in an emailed statement: “We are pleased with the ruling and that the jury agreed the claims against Dr. Patrick McCarthy and Northwestern Memorial Hospital are without merit. Dr. McCarthy is a renowned cardiothoracic surgeon that throughout his career has put his patients’ best interests first.”

Moreover, King disputes Rajamanan’s statement that legal process unearthed new documents, “The documents . . . reflect the standard product review that one would expect of any device manufacturer to engage in regarding the use of the device,” King told TCTMD. “It is also expected that the manufacturer would include the designer of the device who was using the device and was in the best position to comment on its performance. The documents do not suggest the ring was investigational.”

As previously reported by TCTMD, however, new documents have come to light in the course of the long-running controversy, including a request by McCarthy to Northwestern’s Institutional Review Board for permission to conduct a “Mitral Valve Pathology” study in patients who had provided earlier consent to participate in an atrial fibrillation registry. He also requested—and was granted—a patient consent waiver that allowed the study to proceed without triggering FDA notification or patient consent. This previously undisclosed protocol appears to be behind the published study of the Myxo ring later used to support device approval, although the study itself refers only to a “prospectively maintained cardiac surgery registry.”


Related Stories:

 

 

We Recommend

Comments