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Supreme Court to consider 'pre-emption' for drug companies

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Wyeth
Vermont
Supreme Court
Phenergan
Food and Drug Administration (FDA)
Diane Levine

Diane Levine, who lost part of her right arm after a medical mistake, was awarded $6 million by a Vermont jury in her suit against Wyeth. In her case, she contended that the catastrophe that took part of her arm, the misuse of Wyatt drug Phenergan, might have been avoided if Wyeth had adequately warned her about the risks of using the drug.

Now, however, the Supreme Court could throw the Vermont judgment out. Levine has been caught up the battle over "pre-emption," the notion that plaintiffs shouldn't be allowed to bring cases in state court if a product meets federal standards. Advocates of pre-emption argue that since the label on the Phenergan administered to Levine had been approved by the the FDA, she shouldn't be allowed to sue. But Levine argues that Wyeth should be held responsible for not offering a warning on the risks associated with IV push, which caused the gangrene that destroyed her arm when it was incorrectly done on an artery.

Wyeth--and other drug and devicemakers who have taken on similar cases--argue that they couldn't change the label to comply with Vermont law, or they'd violate federal law. Levine and her lawyers, meanwhile, argue that the tougher warning is allowed and that federal law just sets a minimum. 

Now, the Supreme Court will examine, for this case at least, whether the federal standards were enough. The resulting decision, attorneys say, could turn out to be one of the most important of the current term.

To learn more about the case:
- read this piece from the New York Times

Related Articles:
Dems plan anti-preemption bill for devices
Pre-emption debate heats up
Reps introduce anti-preemption bill
Supremes to mull block on drug suits

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Comments

Seems strange ... if a company's FDA package insert talks about a drug's dosing and adverse effects for IV push and it's administered intra-arterially, isn't that a misadministration (different route of adminstration), for which the company has neither legal liability, nor the requirement to warn ... isn't it inherent that all drugs are to be used/administered in accordance with the package insert?

As a nurse, I have been giving phenergan IV for over 25 years. It is the responsibility of the nurse to make sure that the IV is securely in the vein prior to giving ANY IV medication. This can be easily accomplished by drawing back on the IV to check for a blood return prior to injecting the medication.If phenergan leaks outside of the vein into the surrounding tissues, an abscess can and will occur. This can happen with many medications that are routinely given IV. My thought is did the nurse who gave this injection take all necessary steps to insure that The IV was a secure IV line prior to injection?

I was given Phenergan from a nurse who was in to much of a hurry and was over worked,she inserted the med to my IV in my hand, she did it fast and never checked for blood return.It burned bad, pain I never want to feel agin. It burned all my veins and soft tissue and my nerves, it went in to RSD.This has changed my life and my childrens life. I am a Barber and now I can no longer work, it has traveld up my hand and arm.If I was told that this medication could do this type of damage, and there was other meds I could of taken for nausea,I would not of got the injection.I was not told that this med had these side affects,It's a strong medication and that nurse and phenergan have destroyed my life

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