Congress must address device manufacturer immunity to keep patients safe

Tomorrow Congress will hear from the FDA, the medical device industry and health care professionals on the current medical device approval process. The House Energy and Commerce Committee, Subcommittee on Health is holding a hearing entitled “Reauthorization of Medical Device User Fee Act (MDUFA): What It Means for Jobs, Innovation and Patients.”

As Congress works through the reauthorization of MDUFA, the safety of devices needs to be atop the list of concerns when revamping the approval process.  Due to a U.S. Supreme Court decision in 2008 manufacturers of devices that have received FDA pre-market approval (PMA) are immune from liability, even when the devices have been recalled.

Patients that are injured or even killed by these devices are having their court cases dismissed merely because they have a PMA device, leaving manufacturers with no accountability to produce safe devices.

The Medical Device Safety Act (MDSA) would restore the rights of patients injured by faulty medical devices to seek justice in the state court system. MDSA has yet to be introduced in this session, but over 100 members of Congress cosponsored the bill in the 111th Congress.