This case is about as clear an argument against FDA preemption as they get. Here was a company that withheld data from FDA Advisory, and “produced” it shortly after.

While at least some Advisory commmittee members said they would have voted differently had Bayer’s study not been hidden, the cat was out of bag.

Meanwhile, FDA senior management did nothing until withdrawal of drug a year later.

Mangano - who provided the published study on Trasylol’s problems- thinks that the answer is severe sanctioning of comapanies who act in this way.

But, as history has told us ad nauseum, it ain’t going to happen. Meanwhile, civil liability remains, and there are cases going forward. But if FDA preemption happens - as is likely within the current Court - even that means of holding company’s accountable will be history.

Mangano would actually ban companies from filing NDAs for three years as punishment. That truly does seem to punish patients as much as companies. Civil liability looks pretty tame, and reasonable policy, by comparison.