DeLauro, Slaughter Introduce Medical Device Safety Measures
WASHINGTON, DC (May 5, 2017) — Congresswomen Rosa DeLauro (CT-03) and Louise Slaughter (NY-25) this week introduced a package of bills to reform the review process for medical devices and increase access to legal recourse for victims of unsafe devices.
“The U.S. has a systemic problem with medical device oversight and unfortunately the Food and Drug Administration is not doing its job as a regulatory agency. Faulty medical devices, such as St. Jude defibrillators, Essure contraception, and power morcellators have had tragic and life-changing effects on the lives of American families across the country. Congress should step up and pass both the Medical Device Safety Act and Medical Device Guardians Act to give patients more resources needed to ensure their health and safety,” said DeLauro.
“This is about saving lives. I have met with many families who have endured unspeakable tragedy as a result of unsafe medical devices. No one should have to wonder whether a device meant to save a life could malfunction with devastating consequences. Our bills would make badly needed reforms to the FDA’s reporting requirements and offer patients the recourse they deserve when a device malfunctions. It is time for Congress to finally fix this broken system,” said Slaughter.
The bills include:
- Medical Device Safety Act: The permanent sterilization device Essure has led to the death of at least four women and nearly 300 miscarriages. However, under current law, the manufacturer cannot be held liable for their deaths or the harm and suffering the device has inflicted upon tens of thousands of other victims. The Medical Device Safety Act resolves this injustice by allowing victims of Essure—or any future PMA device that causes severe injury or death—to seek legal recourse and ensures medical device manufacturers are incentivized to maintain the safest and most effective products for all patients. The Medical Device Safety Act will do nothing to stifle that innovation: The law only affects a small number of devices that are approved each year by the FDA and it will start to align device laws with drug laws, which currently do not get the same blanket liability protection device manufacturers currently receive.
- Medical Device Guardians Act: Laparoscopic power morcellators are used for hysterectomies and to treat uterine fibroids by grinding, or morcellating, them. However, if the blades hit an undetectable fibroid cancer, it will spread the cancer throughout the body, like shrapnel—taking Stage 1 cancers immediately to Stage 4. Despite this, no one reported this deadly defect to the FDA, until Amy Reed, a mother of six, and a doctor underwent morcellation and her cancer spread throughout her body. Dr. Reed’s patient report to the FDA was the first adverse event report received by the FDA regarding morcellators, despite her same hospital having has a patient harmed by a morcellator one year earlier. After the initial report from Dr. Reed, hundreds of other safety reports began to flow into the FDA. But it should not have fallen upon the patients to bring this to the FDA’s attention. The Medical Device Guardians Act codifies an existing mandate of the American Medical Association’s Code of Medical Ethics, which recognizes 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.
Earlier this year, Government Accountability Office (GAO) released its long-awaited report on 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 took action after receiving a 2013 adverse event report from a patient.