Today, Reps. Brian Fitzpatrick (PA-01), Lloyd Doggett (TX-35), Rosa DeLauro (CT-03), and Jan Schakowsky (IL-09) introduced the Medical Device Guardians Act which codifies an existing mandate of the American Medical Association’s Code of Medical Ethics, recognizing that physicians are in the best position to identify and report unsafe devices. Additionally, the bill adds physicians’ reports to the list of groups, such as hospitals, already protected from having their reporting to the FDA used against them in a civil case.
This legislation was inspired by Dr. Amy Reed, a mother of six, who underwent a procedure using a laparoscopic power morcellator – which is used to treat uterine fibroids by grinding, or morcellating, them. The blades hit an undetectable fibroid cancer and spread it throughout her body, like shrapnel – taking her Stage 1 cancer immediately to Stage 4. She died in 2017 at the age of 44 after fighting her cancer for 42 months.
Her report was the first adverse event report received by the Food and Drug Administration (FDA), despite the same hospital having had a patient harmed by a morcellator one year earlier.
“Underreporting of faulty medical devices has contributed to the harm or death of Americans across the country and we must ensure those on the front lines take the steps necessary to save lives which is what the Medical Device Guardians Act does,” said Rep. Fitzpatrick. “I will continue to raise awareness of faulty or harmful medical devices, and advance legislation that protects patients and puts their interests first.”
“Our bipartisan legislation begins to empower patients with knowledge. By ending what is too often a ‘see something, say nothing’ system, physician reports of medical device dangers can prevent harm to others. Medical devices should save and enhance lives, not ruin and destroy them, as has happened for too many victims across America. Far too often, this industry has put profits over people with insufficient testing of its products and cover-up of hazards,” said Rep. Doggett.
“We need to empower our medical professionals with the ability to report dangerous medical devices and ensure that they feel safe doing so. I am proud to join Representatives Fitzpatrick, DeLauro, and Doggett in introducing the Medical Device Guardians Act, which recognizes that physicians are best equipped to report medical device safety issues or concerns to the Food and Drug Administration,” said Congresswoman Schakowsky. “Americans deserve to know that their doctors can both heal them and protect them.”
In 2017, the Government Accountability Office (GAO) released its report on the FDA’s approval of power morcellators and the failure of the reporting system to catch this unsafe device. The report confirmed serious gaps in the FDA’s device reporting process, including:
- FDA identified significant deviations from medical device reporting requirements at certain user facilities – including the failure to establish and maintain medical device reporting files.
- Regarding adverse events specific to power morcellators, the Director of the FDA’s Center for Devices and Radiological Health noted that “while these events appeared to be the kind that would have fallen under the agency’s medical device reporting requirements, the agency did not see the corresponding adverse event reports submitted to the FDA’s adverse event report database.” Additionally, it was noted that this is not unique, and that there is limited to no reporting to FDA or to manufacturers are some hospitals.
- Overall, thirty identified articles published between 1980 and 2012 “mentioned or concluded a risk of tissue dissemination following the use of a power morcellator, or the need for a physician to remove all fragments of tissue following a surgery.” Yet it was not until 2014 the FDA acted after receiving a 2013 adverse event report from a patient.