Years Later, Myxo Ring Controversy Heads to Courts, Taking on Northwestern Memorial and Star CV Surgeon


Barring another twist, Northwestern Memorial Hospital and one of its star cardiovascular surgeons are headed to court later this month over a long-running controversy related to a mitral annuloplasty ring invented by the surgeon, Patrick McCarthy, MD.

McCarthy is also executive director of the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine (Chicago, IL).

The plaintiff in the case, Maureen Obermeier, alleges that McCarthy’s ring, known as the “Myxo,” was an experimental device she never consented to receive, and that it caused an ST-elevation MI during the implantation procedure and led to the subsequent development of heart failure and the need for an ICD.

Obermeier underwent mitral valve repair at Northwestern Memorial in 2006—her case has been limping through the legal system for more than half a decade. Last month, Northwestern and McCarthy lost their bid to have the case thrown out. A motion judge ruled on January 27, 2016, that specific allegations made by Obermeier related to informed consent and medical battery could move forward to trial.

Of note, Obermeier’s original suit also named Edwards Lifesciences, the device manufacturer. Judge William E. Gomolinski, of Cook County Circuit Court in Illinois, however, granted summary judgment in favor of Edwards, effectively throwing out counts related to product liability, negligent marketing/sale/distribution, and failure to warn/instruct.

Court records outlining Obermeier’s case summarize her claim that McCarthy implanted the Myxo ring, Model 5100, in a clinical study of patients without informing them or obtaining consent while still consulting with Edwards on sizing strategies, necessary tools, surgical techniques, and “other key aspects of the ring system.” She also alleges 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.

Over the years, the device now known as the Myxo ETlogix 5100 ring has been the subject of a US Senate investigation, an FDA rebuke, and at least 2 lawsuits by patients alleging they were never informed that their surgeon was the inventor and that the device was experimental at the time it was used.

Northwestern Memorial, McCarthy, and Edwards Lifesciences have long maintained that no informed consent was needed because the Myxo was permitted for use according to a regulatory loop-hole allowing devices on the market that could be categorized as modifications to already-cleared products. Edwards ended up submitting a new 510(k) to the FDA, which cleared the device 2-and-a-half years after its first use; the agency subsequently revised its guidance as to when new 510(k) applications are needed for medical devices.

In 2014, paperwork acquired from Northwestern Memorial and its affiliated university medical school during the course of an on-again, off-again Senate investigation revealed that back in 2008, certain documents requested by Sen. Chuck Grassley (R-IA) may have been withheld. These included documents showing that McCarthy had asked 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.”

Northwestern had earlier claimed it was a prospective “A-Fib Surgery Registry” that allowed the publication of patient information. Materials provided during the course of Grassley’s investigation show that the A-Fib Surgery Registry study protocol stipulated that no approved or investigational devices would be used.

Northwestern Memorial did not return calls or emails, and Obermeier’s lawyer declined to comment to TCTMD.

 

 

Shelley Wood is Managing Editor of TCTMD and the Editorial Director at CRF. She did her undergraduate degree at McGill…

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