January 9, 2017 · FLEMING | NOLEN | JEZ, L.L.P.
Last month, Congressman Mike Fitzpatrick (PA-08) made the decision to vote against the 21st Century Cures Act. His reason was simple: the bill did not provide enough protection for patients with regard to medical devices. According to the Congressman, there are many measures of the bill with which he agrees, however, he feels that it does not go far enough to protect patients from the harm of dangerous medical devices.
Fitzpatrick has been a long-standing advocate of medical device reform to help raise awareness of the issues. He’s put forth effort to help protect patients from dangerous devices and has worked to get the FDA process altered so there is a focus on patient safety. He claims that Congress has long ignored patients injured by defective medical devices.
Congressman Fitzpatrick has worked to hold the FDA to higher standards. He introduced the Ariel Grace Law which would incentivize medical device manufacturers to develop the safest and most effective products. The goal of this law is to remove the blanket liability protections currently afforded to medical devices approved under Premarket Approval (PMA) by the FDA.
The law is named after Ariel Grace, one of the unborn children who died as a result of Bayer’s Essure device. Patients should be afforded the protection from devices meant to keep them safe. However, when these items cause harm, it can result in long-lasting damages and in some cases, life-threatening injuries.