Patients with leaky heart values and other life-threatening medical conditions put their lives and trust in their doctors’ hands when they are wheeled into the surgery room. They already know the risks, they’ve already read the fine print and signed on the dotted lines of the obligatory hospital forms, and they’ve already given their informed consent… or have they?
The Chicago Tribune recently ran a series of alarming articles about a specific medical device which was the subject of a study on new annuloplasty rings. Myxo ETlogix, invented by Northwestern’s "world-class" heart surgeon, Dr. Patrick McCarthy, was implanted into Northwestern Memorial Hospital’s patients’ hearts before it was FDA approved… by Dr. McCarthy himself. Tribune reporters Deborah L. Shelton and Jason Grotto have opened Chicago patients and their families eyes to a potentially life-threatening wrongdoing on the part of Chicago’s doctors, one of its leading hospitals, and a major medical device company called Edwards Lifesciences.
Tribune reporters introduced us to Antonitsa Vlahoulis of Niles, Illinois. She, among 700+ other patients, learned the full truth about the medical device permanently stitched into her heart a little too late. After she was released from the hospital from receiving leaky heart valve surgery, she received a warranty card in the mail regarding the device her surgeon chose to implant. It was his creation: McCarthy Annuplasty Ring (now Myxo ETlogix). This product wasn’t one of the options Dr. McCarthy had discussed giving her pre-surgery and, more shockingly, it wasn’t on the FDA’s list of approved devices. In fact, when Vlahoulis received the implant, it was still being studied. She did not give her informed consent to receive the "experimental" product, and a few years later, suffered permanent injuries due to the device.
We also read Maureen Obermeier’s story from the Chicago Tribune article series covering this story. She received a Myxo ETlogix during her 2006 heart surgery, and only learned she had the device implanted in her when her doctor forwarded her information about it from a cardiology journal.
"As inventor of the ring," Obermeier said, "McCarthy had a financial and professional conflict of interest that gave him incentives to select it over others."
McCarthy reported in a the Tribune’s interview that he was unaware his device had yet to be approved by the FDA when he was implanting them into patients’ hearts. The Tribune reported that McCarthy, who does about 150 valve surgeries a year, said that at the time of the controversy, "he had no knowledge of the rules governing medical devices and that he relies on industry and the FDA to ensure the ones he uses are safe and effective." In short, he said: "There are no guideposts for us. You don’t learn about this stuff in med school." Dr. McCarthy did admit to the Tribune that he had stopped telling patients some of the heart rings he uses were his inventions because most didn’t seem interested in such details.
So who’s the main culprit here? The doctors and hospitals who rely on the manufacturer’s word regarding the products they are purchasing being FDA approved? Or the manufacturers themselves? Perhaps both. California-based Edwards Lifesciences did not submit McCarthy’s heart rings to the FDA for review before McCarthy was given the green light. The company argued (incorrectly) that it wasn’t required to do so, reports the Tribune. While the FDA investigation found that Edwards Lifesciences should have sought clearance before allowing surgeons to use the heart devices, it didn’t take action against the company due to its "good faith effort to follow the law."
Lest us not forget the procedure that’s involved in implanting these controversial devices: patients’ "chests are opened, their hearts are stopped and the life-sustaining device is stitched into the valve while a heart-lung bypass machine keeps them alive." These patients can’t exactly bring in their warranty card after the fact and request a refund or exchange.
So who should we as consumers of products like these trust? The FDA who does seemingly non-thorough investigations of such important, life-saving devices? The manufacturer itself whose "driven to help patients and develop innovative technologies that save and enhance lives" and just happens to make billions in the industry doing so? Or should we trust the doctors who receive royalty checks from their own patented creations that they choose over other devices to implant in their patients? The surgeon who co-authored the study of Myxo ETlogix, Dr. Rajamannan, believed the device was experimental at the time the surgeries took place. However, in January 2009, Northwestern hospital’s president and CEO, Dean Harrison, sent a letter to Vlahoulis and other patients who had received the Myxo ring stating that "we do not consider this device to be experimental," reports the Tribune.
The Tribune reporters who covered this cautionary tale tell us that "soon, medical device companies may be required to disclose more information about payments they make to doctors. The Physician Payments Sunshine Act was passed last year, and Congress, the FDA and the industry are wrangling over how to implement it." Hopefully other actions will be taken from those in power who can make a difference in the medical community. At the end of the day, it’s not about blame-shifting and pointing fingers, it’s about righting a wrong and making the medical industry safer for patients.