Lawmakers Announce Package of Medical Device, FDA Reform Bills

Congressman Mike Fitzpatrick (R-Pa.) and Congresswoman Louise Slaughter (D-N.Y.) joined families impacted by dangerous medical devices this week  outside the U.S. Capitol to announce the introduction of a package of bills to reform the review process for medical devices and increase access to legal recourse for victims of unsafe devices.
 
“While many medical devices prove lifesaving, we know that some can cause harm and have devastating consequences on patient I think everyone would agree that when a medical device is found to be unsafe, there needs to be an effective process in place to track these failures, to remove devices from the market, and provide legal recourse for those impacted. Currently, that process is failing us, and our constituents are paying the price,” said Fitzpatrick. “It’s time we reform the FDA, its processes and procedures to allow for maximum innovation and maximum safety. Agencies, physicians and lawmakers should all be committed to this common cause, and open to these bipartisan solutions.”
 
“I’m eternally grateful for all the families that have worked with Congressman Fitzpatrick and me to prevent more people from going through the tragedy that they’ve endured,” said Slaughter. “These bills are about saving lives. We’ve seen firsthand how devastating it is when a medical device has an unintended, adverse consequence. It’s time for Congress to make commonsense changes to protect patients and give them the information that could help save lives.”
 
The bills include:

• Ariel Grace’s Law: The permanent sterilization device Essure has led to the death of at least four women and nearly 300 unborn children, including Ariel Grace who was stillborn following failure of the device. However, under current law, the manufacturer cannot be held liable for her death or the harm and suffering the device has inflicted upon tens of thousands of other victims.

 
Ariel Grace’s Law resolves this injustice by allowing victims to seek legal recourse and ensures medical device manufacturers are incentivized to maintain the safest and most effective products for all patients.
 
“This past year has been more than a roller coaster ride for our family—giving birth to a sleeping angel at 27 weeks, then turning around and burying her, followed by a hysterectomy five months later,” said Kristiana Burrell of Fairview N.C. “My hopes are that Ariel Grace’s Law will save many other women from going through what my family, and hundreds of others, had to endure. Ariel Grace was called ‘our perfect instrument for change’ at her memorial service and I wholeheartedly believe that. She is not the only baby that has been born sleeping due to Essure, however, I believe she can be the face for this change. If she can save one woman or one baby, I know she did not die in vain….our perfect instrument for change.”
 

• 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 U.S. Food and Drug Administration (FDA) until Amy Reed, a doctor and mother of six, underwent morcellation and her cancer spread throughout her body. Reed’s patient report to the FDA was the first adverse event report received by the FDA regarding morcellators, despite her same hospital having had a patient harmed by a morcellator one year earlier. After the initial report from 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. 
 
“I stand here to attest that for over two decades American citizens have been harmed by a harmful medical device bearing the stamp of approval by an agency of our Federal government,” said Reed. “Our suffering has been the result of a collage of personal, professional and legislative failures which the Medical Device Guardians Act will serve to correct. Thank you, representatives Fitzpatrick and Slaughter, for spearheading this bill, to ensuring that the FDA has access to immediate and high fidelity data on adverse events from individual physicians and practitioners.”
 
Last year, Fitzpatrick and Slaughter successfully commissioned a Government Accountability Office (GAO) investigation into FDA’s approval of power morcellators and the failure of the reporting system to catch this unsafe device. Fitzpatrick continues to be an advocate for FDA and medical device reform and continues to call for an Energy & Commerce Committee hearing on medical device safety and FDA process alteration.