Tort reformers feel like they are about to win. Unfortunately, if FDA preemption becomes “The Law of the Land,” they will be amongst the victims.

If you wish to believe you are correct, that’s fine. I don’t enjoy fencing games.

I would suggest looking through this site for other discussions of it or just google FDA preemption.

It has nothing to do with levels of courts, etc. If and when preemption is upheld (as it already has been in the device arena), it has the force that any Supreme Court decision - Roe v. Wade, etc.. It is “the law of the land.” Once that happens, no Appelate court is going to take a case based on a doctrine that, in essence, the Supreme Court has already ruled on. Periodisimo.

I have had a lot of experience in these matters and there are many latent areas ANY lawyer could attack. To say that the final word would be the FDA is not accurate. In the court system there are three tiers, Superior, Appellate and then the Supreme court. “Appellate” means just that, “appeals”.

Many people do not understand that anyone can sue, but will they prevail? So to say the FDA is the end of the line is naive.

Usually, attorneys sue who they think are culpable, not the FDA. The FDA rules may then be used as evidence if it is to the benefit of plaintiff counsel. The same would hold for the defendant. Sometimes they do prevail.

Do you understand what preemption in the case of drugs truly means? There would be no lawsuits at the federal level. If a drug is FDA approved case closed.

Maybe I’m missing something in your view of preemption.

I’ll go out on a limb, the feds will have the preemption over states. There are just too many technical/scientific considerations for states to enter this forum as the last word in pharmas/bios.

Of course, there are larger penalties in a federal court than state. Many lawyers would love to see this as a potential open door to riches.

If this was the case with the past action by the FDA, I don’t think anyone would have a problem with it. But the above scenario, as the FDA stands today, would be:

The accused is then presented to the FDA, who send him a warning letter 8 months later telling him not to kill anyone else and he goes home.

That would make sense except that it essentially never happens. As often discussed here, and documented by various sources, the FDA/DOJ bring almost no enforcement actions, particularly in the drug arena, that create meaningful accountability. There are several reasons for this that I won’t reiterate. Ironically, again as documented in a recent post by Ed, the few more serious actions it does take (very rarely) are triggered by outside sources - whistleblowers or the very civil liability system that preemption would make irrelevant.

So the loop is closed, the door is locked, and the lights turned off.