The US position on state sovereignty can create messy situations. Recent government administrations have taken oppposite sides of this thorny one (Clinton’s for, Bush’s against)–does federal approval of medical devices shield manufacturers from product liability lawsuits in state courts. So far, according to this AP story, most federal appeals courts have said, yes, indeed, if your FDA-approved device fails during my operation, I can sue you anyway in state court.
Given the maze of legislative entanglements device manufacturers face anyway–federal regs in the US and, heck, there’s even a Journal of Medical Device Regulations–a decisive ruling here will be welcome. It’s always a delicate balance between getting new technology out to the public and making sure safety and effectiveness are kept in balance.
If you’ve got some time to kill, here’s the US government’s stuff on the topic of medical device safety.