Here’s the background.
The Food and Drug Administration changed its policies in 2006, adopting rules that said its approval of a drug insulated companies from state lawsuits.
But Justice John Paul Stevens, writing for the majority, said there was "powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”
Whether it DID intend that or not, such oversight shouldn’t be limited to the resource-strapped, Big Pharma-friendly FDA anyway.
Basically, in cases like the one under ruling, drug companies were saying:
Even if we have internal knowledge of problems with one of our drugs, beyond what the FDA knows, we should be allowed to continue selling it.
In other words, Big Pharma wanted absolution from willful negligence.
In fact, Wyeth attorney Bert Rein says his company was prohibited from going beyond FDA warnings.
BULLSHIT!
Did you or any other attorney ever ask FDA about that?
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