In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturers of certain medical devices approved by the Food and Drug Administration (FDA)’s pre-market approval process are immune from liability, even when the devices are known to be defective and potentially hazardous to consumers.
Granting these manufacturers complete immunity from lawsuits puts consumers at risk. Government regulations set a minimum safety standard. The FDA does not test drugs and devices, but instead relies on corporations to act responsibly and provide accurate information about the safety of their products. State tort claims provide an added check on corporations by providing incentive for manufacturers to make their products safer, and often bring safety problems to the public’s attention.
Congress must pass the Medical Device Safety Act (MDSA), legislation that would restore the right of patients to hold manufacturers of medical devices accountable in court when their devices have malfunctioned.