Tom Rush speaks on Diana Levine's US Supreme Court Case

[soldz303]

All drugs are poisons that is, whether they are FDA-approved. Check this out, for a drug with one beneficial effect equals hundreds of possible side/adverse effects. In fact, drugs are not designed to cure diseases. As for Phenergan, the sedation it induced tricks your brain to alleviate nausea or vomiting. So whatever route this drug should have been given does not make it safe anyway. A poison is a poison no matter how small. Just my humble opinion.

[Wivanunu]

I think this case is just terrible....I suffer from awful migraines and understand how nausea needs to be relieved. Phenergan is an antihistamine...and given the correct way...it can make migraines much easier to deal with. Bendadryl can help with nausea.....I never consider that a poison.....it has saved many lives!

[Winnjn5]

I do see what your are saying, but which is worse? Fraudulent law suits, or valid ones that can't be heard because the product has been approved by the FDA? Of course, as you may have guessed by my youtube name, I do have a bit of a bias... then I also know the full story.

[sklanger]

If you knew the full story, then you would have known that the it was the practitioner who was squarely at fault - disregarding multiple, clear warnings on the potential dangers of using IV-push as a method of administration, while negligently giving double the dosage. The practitioner is not merely "partially" at fault. He or she was squarely at fault. Yet Levine settled with them for a measly $700k.

Either the FDA is correct or the state court jury is. Not both. And preemption favors the FDA.

[Winnjn5]

The FDA isn't claiming anything you idiot. WYETH is trying to hide behind the FDA. Preemption favors the drug company(ies) and big business, because it puts the full brunt of any issues on the FDA's shoulders.

Think what you want. Diana is a close relative, so I am by no means impartial. Therefore, my first inclination is to tell you to "stick it".

[sklanger]

The FDA is claiming preemption you moron. The DOJ filed an amicus brief in support of Wyeth because Levine's claim undermines the FDA's drug approval process and contradicts its labeling directives allowing IV push as a means of administration. Either state juries make such determinations, or the FDA does. It cannot be both as they are contradictory.

Preemption favors the drug company and the FDA as a matter of precedent, &because otherwise the regulatory process would be thrown into disarray.

[Winnjn5]

You are missing a few of major points.

1. She won her case at the state level

2. Whether you agree with the case or not, the bigger issue is preemption. I would encourage you to read more about the ramifications of this case.

3. There is no advantage to administering this drug intravenously, and while the practitioner is partially at fault for missing the vein, IV (or Push IV in this case) should not be an accepted method of administering this drug. PERIOD.

[sklanger]

Well then, sue the FDA. Why should the drug company be penalized for complying with federal law?

[Dwarvenwarmaster]

I completely disagree. Usually I favor the consumer over the drug companies as they are in it only for themselves and will do anything, and in some cases take illegal actions in order to make a dollar. However Phenergan is not approved for intra-arterial use. It can, however, be given IV or IM. As a pharmacist married to a nursing student I know that it is extremely rare for an IV drug to be given IA by mistake. "It is not an easy mistake and the chances are not so great".

[DulciPicker]

This is indeed a terrible wrong that cannot be righted. Thanks for this information. It's not the kind of story that makes the news, although it should. I've never heard of Phenergan being administered as anything other than a suppository.

[warnersongs]

Well said, Tom.