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Surgeon Accused of Human Experimentation in Lawsuit Trial

The lawsuit in Chicago is against the chief of cardiac surgery at Northwestern University. Patrick McCarthy, MD, is accused of improperly experimenting on patients with Edwards Lifesciences' Myxo Ring--a device he invented. Northwestern Medicine says McCarthy was merely doing what doctors are supposed to do: provide the best care possible for his patients.

Patrick McCarthy Northwestern
Patrick McCarthy, MD

Qmed Staff

Updated March 21, 2016

A jury trial is underway this week over a malpractice lawsuit against Patrick McCarthy, MD, a surgeon and inventor accused of experimenting with an uncleared cardiovascular device on his patients.

Plaintiff Maureen Obermeier claims that McCarthy about 10 years ago inserted a Myxo Ring mitral valve device into her heart without her consent, and that the device resulted in a 2006 heart attack and other complications. McCarthy is the top cardiac surgeon at Northwestern University's teaching hospital. He also happens to be the Myxo Ring's inventor.

"He was putting it into patients, seeing how it worked, and not telling them," Obermeier's attorney Adrwin Boyer said during opening statements, according to Fox 32 in Chicago.

The judge in Chicago previously dismissed Edwards Lifesciences, the Myxo Ring's maker, as a defendant in Obermeier's lawsuit. Besides McCarthy, Northwestern Memorial Hospital and the Northwestern Medical Faculty Foundation are being sued.

McCarthy has strenuously denied the accusations that he implanted an experimental device into roughly 100 patients without informed consent in 2006 and 2007. He told the Chicago Tribune in 2011 that both he and Northwestern Memorial Hospital had received assurances from Edwards that it was cleared for use under FDA rules.

"Dr. McCarthy used a legally marketed device because he determined that it was the best annuloplasty ring to repair the patient's diseased valve. He chose it because it was in the best interest of the patient," Northwestern Medicine says in a statement shared with Qmed. The statement said McCarthy's work was not a clinical research study, though he did publish an outcomes research paper based on the 100 patients.

The statement also notes: "In this case, the court granted summary judgment in favor of Edwards Lifesciences, the manufacturer of the ring, because the plaintiff failed to provide any evidence or testimony that the ring was unsafe or defective."

The Myxo ring--a device designed to treat degenerative myxomatous disease of the mitral valve--appears to have been one of a number of apparent disconnects over medical device indications that have taken place in the U.S. over the past 10 years.

Edwards Lifesciences claimed it could sell the device because it was substantially equivalent to other previously 510(k) cleared mitral valve replacement devices. FDA, however, disagreed. It  required Edwards to change the name of the device before granting an investigational device exemption (IDE)--all done after-the-fact. Even after all of that, FDA still issued a warning letter referencing the Myxo under its new device name "dETlogix." FDA deemed the device misbranded because the company had failed to report serious adverse events.

FDA ordered McCarthy to stop implanting the Myxo Ring until appropriate regulatory clearance was obtained, according to a 2009 letter from the FDA congressional office to then-Sen. Richard Lugar, R-IN.

In the case of the Edwards Lifesciences rings, more than 6000 adverse events are listed in FDA's MAUDE database.

Edwards ended up removing the Myxo device from the U.S. market, describing the move as a "voluntary retrieval" in its 2009 SEC 10-K filings. An identical Myxo device, though, was recently still on the market in Europe.

"Patient safety is always our top priority, and we stand by the safety and efficacy of the Myxo ring," says Edwards Lifesciences spokesperson Sarah Huoh. "As it pertains to this case, Edwards received a dismissal on motion for summary judgment, which typically occurs when the facts are insufficient to support the plaintiff's claims. The Myxo ring used in the treatment of the patient in this case has the same design as the device that is described in the 510(k) clearance provided by FDA."

"Edwards Lifesciences considered this matter concluded when the FDA provided 510(k) clearance for the Myxo ring in April 2009," Huoh adds. "The discussion as it relates to this device is one of process, not patient safety, and Edwards has been transparent on the regulatory processes we have followed. The company has focused significant efforts on future innovations for mitral valve therapy and, as part of this commitment to advancing the field of heart valve repair and replacement and our ongoing planning for the introduction of newer devices, we have retired certain products, including the Myxo ring." 

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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