Lawsuits, the FDA, and Medical Devices
Turns out that the Supreme Court ruled in favor of Medtronic today, saying that a company that manufactures an FDA approved device can not be sued under state laws if that device causes injury.
The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”
Interesting. It kind of ups the pressure on the FDA during the approval process, doesn’t it?
There is a distinct lack of faith in juries to understand the risk vs. reward thing too.
“It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives,” Justice Scalia wrote, noting that the F.D.A. approved a ventricular assist device for children with failing hearts “even though the survival rate of children using the device was less than 50 percent.”
