Many patients are aware that, as a part of their surgeries, their physician will select the medical device implanted during surgery. Patients who take great care in selecting their physicians, surgeons, and hospitals, often simply trust those individuals and institutions to select the hardware to be used. Patients assume that reputable hospitals will only approve carefully screened, approved devices. They assume incorrectly.
As recently reported by the Chicago Tribune, some surgeons even use their patients to test their inventions, and use data from their patients to study the devices and seek approval. And patients are not told of this potential conflict of interest of their surgeons implanting their own medical device inventions.
Some patients never learn that the devices implanted in their bodies are unapproved, experimental technology. Others learn only well after the fact, when warranty cards arrive or things begin to go wrong.
The Tribune report focused one of the world’s elite heart surgeons, Dr. Patrick McCarthy, on staff at Northwestern Memorial Hospital. Not only is Dr. McCarthy a world class heart surgeon, but he is also the inventor of two annuloplasy rings (used to treat valve disease), including the McCarthy Annuloplasty Ring.
The allegations in the report are that Dr. McCarthy implanted his inventions into more than 700 patients during heart surgery, all prior to approval by the FDA. Indeed, at the time of many of the surgeries, the rings had not even been submitted to the FDA. Even more alarming, Dr. McCarthy is accused of providing patients with lists of approved devices for their surgery (which did not contain his own ring), and then implanting his own invention.
McCarthy claims that he was under the impression that the rings had been approved – indeed, that he had been told by the manufacturer, Edwards Lifesciences, that approval was granted. Northwestern also asserts that it had received the same assurances, and stated that it relied upon assurances from Edwards that use of the devices was legal.
McCarthy further asserts that he was completely unaware of the rules governing FDA approval of medical devices, passing the blame on to medical schools, which he asserts do not instruct physicians in these types of rules.
And although McCarthy has stated that he did not consider the devices to be experimental, he was at the time of the surgeries conducting a study comparing the performance of his inventions to other devices on the market.
The test subjects? His patients.
McCarthy claims he was not studying the device – he was using it and then reviewing the results. To our medical malpractice lawyers of Passen & Powell — as well as the “test” patients of Dr. McCarthy – this is a distinction without a difference.
As part of the fallout from the McCarthy controversy, Northwestern has – only now – put in place a policy whereby patients are informed in writing if their surgeons or physicians are receiving royalties for devices they created. The hospital has also – again, only now – appointed a committee to confirm that devices used at the hospital have received proper FDA clearance. And even that committee simply relies on information from the manufacturers – exactly the process that led to McCarthy’s conduct.
Several lawsuits have already been filed as a result of McCarthy’s dangerous practices. Hopefully this will encourage doctors and hospitals will take real, meaningful action to stop this dangerous and disturbing practice.
For a free consultation with an experienced Chicago medical malpractice lawyer at Passen & Powell, call us at (312) 527-4500.
