Reps. Mike Fitzpatrick (R-Pa.) and Louise Slaughter (D-N.Y.) on Wednesday introduced a pair of bills designed to crack down on the medical device review and approval process. It is not clear whether they will see any action in committee this year.
“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,” Fitzpatrick said.
The first bill, dubbed Ariel Grace’s Law, would allow the manufacturer of Essure, a permanent sterilization device, to be held liable for harm caused to patients. The device has led to the death of at least four women and nearly 300 unborn children. If passed, the new law would allow victims to seek legal recourse. It also would ensure that medical device manufacturers are incentivized to maintain safe and effective products.
The second law, the Medical Device Guardians Act, would put existing medical ethics into law by recognizing physicians are best suited to identify and report unsafe medical devices. It also would add physicians to the list of groups protected from having their reports to the Food and Drug Administration used against them in a civil case.
“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,” Slaughter said.