Two Bills Introduced on Medical Device Safety

Reps. Michael Fitzpatrick (R-PA) and Louise Slaughter (D-NY) have introduced two bills to improve medical device safety and allow those harmed by devices to seek legal recourse. Fitzpatrick has been an outspoken advocate for FDA and medical device reform and continues to call for an Energy & Commerce Committee hearing on medical device safety and FDA process reforms. Specifically, he has rallied around patients allegedly harmed by power morcellators and the Essure birth control implant.

The Medical Device Guardians Act would amend the Food, Drug, and Cosmetic Act to require physicians and physician’s offices to be treated as covered device users required to report on certain adverse events involving medical devices. As such, a covered user would be protected from having their reporting to the agency used against them in a civil case.  The lawmakers also introduced the Ariel Grace’s Law that would allow patients harmed by medical device to seek legal recourse and compensation for damages.