Allison M. Zieve, a Washington, D.C. attorney with the non-profit consumer advocacy organization Public Citizen, argued on Riegel's behalf during oral argument.
Approval by the FDA
said, is no guarantee that devices are not problematic or dangerous.
"After the company submits the application, the FDA
evaluates it, based on information submitted, but it does no independent testing, no product development, no comparison with other products to see if this one is as good as or better than existing products, or even if it's the best that it can be," Zieve
"Once on the market, a PMA device may prove to be unsafe, because very often problems and hazards come to light only after the device is in widespread use."
ran into trouble when Justice Antonin Scalia asked her
if states were free to impose additional regulations on drugs and devices.
"If there is not a specific federal requirement that is the counterpart to a state requirement, there is no preemption," Zieve
replied: "If the device is reasonably safe and effective, then the company is just not going to stop marketing it because of tort suits."
Scalia said jurors may not be in the best position to set standards for medical device safety.
"It is not as though some expert agency of the state has conducted a very scientific inquiry and decided that there's something safer than what the FDA