Representative Mike Fitzpatrick (R-Pa.) has been crusading for better regulations for medical devices for some time now, and he is taking his concerns to his Congressional peers. Rep. Fitzpatrick has asked the Committee on Energy and Commerce to hold a hearing with the goal of updating laws regarding medical devices.
But this isn’t Rep. Fitzpatrick’s first rodeo. He has also drafted and introduced two separate bills into Congress that aim to reshape how potentially defective medical devices are reported and help hold manufacturers responsible for producing defective devices.
The first Bill, called the Medical Device Guardian’s Act would require doctors by law to report any adverse events related to medical devices. Under the current system, reporting is completely voluntary, which makes the identification of defective devices incredibly challenging. Rep. Fitzpatrick was inspired to sponsor the Bill after a delay in public awareness of the risks associated with power morcellators, coupled with widespread usage in patients who were not adequately warned of the risks, led to spreading cancer in hundreds of women. The FDA approved power morcellators in the 1990s, but the first adverse event was not reported until 2013. The Medical Device Guardian’s Act would drastically limit the amount of time required to identify dangerous devices.
The second Bill Rep. Fitzpatrick introduced, called Ariel Grace’s Law, takes aim at Bayer A.G.’s controversial contraceptive device, Essure. The Bill was named after a child that died in utero do to complications from the Essure device. The Bill would not only take Essure off the market, but it would also eliminate a federal preemption law that has protected Bayer from liability.
Rep. Fitzpatrick’s hearing will likely take some time, as the regulation of medical devices is highly contested; but his dogged pursuit of irresponsible device manufacturers has many convinced he will be ultimately successful.