http://colloquy.law.northwestern.edu/main/2008/07/what-riegel-por.html

If you download the PDF, you’ll get the whole article. (Otherwise, the site just has Part I.)

Certainly, if the Effexor history is as related, Wyeth would be shielded, which I would take as a good thing.

Keep in mind that FDA approval and compliance are _already_ a part of virtually ever failure-to-warn claim. That is, even without automatic preemption, companies have been claiming for many years that they were in compliance with FDA, and that defense - if supportable - has served them well. So it is not as though FDA approval/compliance has not been part of the picture all along. That is also why FDA itself, until the current administration, has not viewed the tort system as competing with its own regulation. Instead, it has explicitly described it as “complementary” in monst instances. Please do hold on to that point - it’s an important one.

The point of preemption is that FDA approval/complaince would be the _only_ thing in the picture. And, yes, this would include even situations of a company committing fraud or other serious misrepresentations - either to FDA, physicians, or the public

Like pregancy, I’m not sure there is such a thing as having a “little bit of preemption,” but Sharkey’s position may be a road to that end.

It is possible that Laurie has cited the example I’ve asked for - where a company added a warning, withdrew it because of FDA disagreement, and then was sued for not having it.

Obviously, I would side with the company in such instances. And I can’t imagine they would have lost a suit if they had had to remove a warning that the FDA rejected. I am still awaiting some kind of evidence that happened - warning added, FDA rejected, company sued, suffered consequences.

I was also responding to the notion that FDA itself would hold the company for “misbranding,” which is one of the stock points of the preemption folks. Again in the context of an _added_ warning, which is what my post concerned, I do not believe FDA ever penalized a company in such a context. The warning was simply removed.

Actually, preemption will make it virtually impossible to seek legal recourse.

A policy that undermines our civil liberties is dangerous. Giving product immunity to any industry in unconscionable.

Tort reformers like to play the frivolous lawsuit hand. This has been a favorite tactic to “educate” Americans against trial lawyers. In reality, cases without merit usually do not go to trial.

“There are two legal mechanisms that quickly and inexpensively resolve frivolous lawsuits. The truly frivolous lawsuits are often ‘thrown out of court’ when the defendant files a motion to dismiss. If that fails, a defendant may still file a motion for summary judgment, which requires the plaintiff to present actual evidence that he or she ‘has a case’ and that there are no laws that prevent the plaintiff from winning.

Motions for summary judgment are decided by judges – not juries - so any lawsuit that makes it past a summary judgment has some merit. Motions to dismiss and motions for summary judgment quickly and inexpensively weed out lawsuits that don’t have any merit. And often, a plaintiff on the losing end of either motion is ordered by the court to pay the defendant’s legal fees, thus discouraging people from filing frivolous suits in the first place.” - http://www.corpreform.com/questions_answers/index.html

It is expensive to go forward with a claim after it has been dismissed. The average person would not be able to do so.

Most frivolous cases are filed by big corporations who can risk the cost.
See: Public Citizen | Press Room - U.S. Businesses File Four Times More Lawsuits Than Private Citizens And Are Sanctioned Much More Often for Frivolous Suits - http://www.citizen.org/pressroom/release.cfm?ID=1799

What we need is education about the erosion of our civil liberties under the Bush administration.

This was probably the Effexor warning. Wyeth wanted to put the suicide/violence warning on it’s labeling. The FDA was in the process of investigating this effect and told Wyeth to remove their warning until the Columbia study was completed. It was removed because the FDA wanted a consistent warning across the category of ssri/snri drugs after the study was completed.

And Dianne - i understand that preemption may make it harder to seek recourse in a legitimate case in which a plaintiff has been injured, but i think it’s important to look at both sides: without preemption, there could be many frivilous or unfounded lawsuits alongside those legitimate ones, the one result of which would be to cause pharma to cover their legal losses by again raising the cost of medications that are already expensive enough. This is not to say i’m for unconditional preemption or for an unconditional lack of preemption. Perhaps there needs to be some other means by which situations such as this could be avoided.

If you know of a case in which a company has been sued for conveying a precaution not otherwise on the label, please do let us know. Otherwise, it is one of those “rumors” that have a way of coming from to Corp Lawyers, Inc.

FDA preemption takes away the right of the injured party to seek justice. If we are stripped of that right, the facts of a case will not come out, industry will be shielded, and our health and safety will be in peril.

I would rather stay with Freedom and Justice for All.