What the Supreme Court gives, Congress may take away. Democrats are planning to introduce legislation that would specify that FDA regulation doesn't shield device makers from state liability suits.
You'll recall that in February, the Supremes ruled that patients can't sue in state courts over FDA-approved medical devices. The high court said that the 1976 Medical Devices Amendment preempted patients' rights to sue in state court.
The justices are set to hear a preemption case involving drugs--a Wyeth drug, to be exact--this fall. And the debate over whether FDA approval should protect manufacturers from lawsuits is really heating up as that date approaches.
- read the Pharmalot post
- check out the Congress Daily story