In June 2016, Representative Mark Fitzpatrick (R-PA) and Representative Louise Slaughter (D-NY) introduced the bipartisan bill, Ariel Grace’s Law. NCHR president Dr. Diana Zuckerman explains that the NCHR believes the bill is needed because “it provides an important incentive for manufacturers to do a better job of testing the safety of their implants and other devices. The incentive would be their desire to avoid law suits by patients harmed by defective high-risk medical devices.”
Under the law, the highest-risk devices (called Class III by the FDA) are required to be proven “reasonably safe” and “reasonably effective” in studies of patients (called clinical trials) before they can be sold in the U.S. However, these studies are often small, short, and without good comparison groups of patients who did not use the device. In a Supreme Court decision written by Justice Antonin Scalia, the court decided that patients harmed by these devices can’t sue. “This decision makes no sense, since prescription drugs are held to much higher scientific standards, but patients harmed by them have the right to sue,” explains Zuckerman. If Ariel Grace’s Law passes, then patients will be able to sue manufacturers whose defective Class III devices have harmed them.
The bill is strongly supported by several patient groups, such as patients who have been injured by medical devices.
The National Center for Health Research (NCHR) conducts and scrutinizes research and works to improve policies that affect the health of adults and children across the country. NCHR supports this bill, based on its research indicating that even the highest risk medical devices are often not held to stringent scientific standards of evidence of safety or effectiveness.