Let's say that Fred over here comes to me and asks me to certify that his baseball bat is a harmless piece of sports equipment. As the duly authorized authority on such things, I do so. Then Fred whacks you in the head with the bat. The Supreme Court subsequently rules that since I certified Fred's bat as harmless and I must know what I'm doing, you can't sue Fred for whacking you.
Trouble is, everybody including the GAO and my own staff (at the imaginary regulatory authority I've created for the purposes of this thought experiment) knows and has said publically that I'm underfunded, understaffed, and underclued. But still, since Fred conducted some kind of clinical trials for his bat and I accepted them as good science, Fred is off the legal hook.
That's basically what just happened in the realm of medical devices. The Supremes ruled that a man who was critically injured by an allegedly defective Medtronic inflatible heart catheter can't sue Medtronic, since the device was FDA approved. And apparently the ruling may be extended to cover drugs, too. This is one to watch.
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