Comments on: Wyeth v. Levine

By: NateRN

NateRN — Sat, 22 Nov 2008 08:57:13 +0000

It’s taken me a while to realize that promethazine is given far more routinely than is appropriate. It’s a dangerous drug (although, IMO, more because of its sedating properties). It’s also a drug of abuse, and I have no idea why it’s not monitored by the DEA, while I have to count the Sudafed in my Pyxis twice every week.

Look, the PA gave it wrong. We can’t hold drug companies accountable for every improperly administered dose. That’s not reasonable.

At the same time, it wouldn’t be surprising to me to learn that the PA or physician involved was unaware of its vessicant properties. Can we actually expect every provider to know everything about every drug? Sure, that’s what we do expect, but it’s not realistic either.

By: Michael Cannon Is Offended « WhiteCoat Rants

Michael Cannon Is Offended « WhiteCoat Rants — Fri, 31 Oct 2008 11:31:16 +0000

[...] Posts Clostridium difficile Not A Medical Error? Wyeth v. Levine – Hide The Soda StrawsWyeth v. LevineTreatment By Non-PhysiciansDo Not Use These Medical Abbreviations!Nurse ComicI’m Not As Dumb As I [...]

By: Tiny Shrink

Tiny Shrink — Thu, 30 Oct 2008 02:57:35 +0000

ERP: No, I don’t think we have to sign consents for everything. My god, the risks of normal saline IV fluid, if you list them all out, including the BS hypersomatic reactions some patients get to every possible medication, would take all damn day. I wasn’t saying I AGREED with the patient, I was just saying I think her point would be better served by making an informed consent argument. Of course, she’s already gotten money from the people who actually made the mistake, and they’re the ones who provide informed consent, not Wyeth, so she (and her lawyers) wouldn’t have $$$ at stake from Wyeth if they built the case on informed consent.

By: Wyeth v. Levine - Hide The Soda Straws « WhiteCoat Rants

Wyeth v. Levine - Hide The Soda Straws « WhiteCoat Rants — Wed, 29 Oct 2008 11:32:07 +0000

[...] Posts Wyeth v. LevineTreatment By Non-PhysiciansWhy Stop With Spreading Wealth?Nurse ComicCanaries In The Coal MineForgot [...]

By: ERP

ERP — Wed, 29 Oct 2008 03:08:07 +0000

Wait a second Tiny Shrink, this danger (accidental arterial injection) exists with TONS of drugs. Are you saying we should have everyone sign consent for any drug we give them?

By: Tiny Shrink

Tiny Shrink — Wed, 29 Oct 2008 00:36:26 +0000

I agree with the commenter from ERP’s blog that this case is not the best case to test preemption. If you read the plaintiff’s statements, she’s actually angry about the lack of properly informed consent; she feels that she wouldn’t have consented to the IV medication had she known that there was a risk of accidental IA injection with gangrene. Since gangrene is a rare but known complication of IV Phenergan, when given IA, she feels she should have been told of this. While it’s true that the Supreme Court is using this as a preemption case, it will have to be decided on the merits of this particular case, which aren’t very suited for this purpose.

By: Braden

Braden — Tue, 28 Oct 2008 16:50:37 +0000

I started commenting on this, but then it grew and grew and I decided not to take up all your space with my bloviating, so I gave it more space on my own blog. Go read my sleep-deprived opinion at my blog.

By: Boy Genius

Boy Genius — Tue, 28 Oct 2008 15:57:16 +0000

I’m a Actuarial science/health economics major (read “bean counter”). In economics there is no such thing as a perfect solution only trade offs. Optimizing the utility of a given treatment is notoriously difficult given genetic variability. I have asthma and could tell you how much fun it was finding an inhaled steroid that works effectively. The more I learn the more I’m inclined to support a clinician handing someone a print out of the FDA warnings and placing the responsibility of weighing the risks between a patient and his/her provider. The premise being that if you don’t trust the judgment of your physician to advise you appropriately and lack the requisite mental capacity to make a decision you are likely in such bad shape that this won’t

I, in principle, opt for individual liberty and personal autonomy whenever possible. No I’m not as naive as I may initially appear. This post has kept purposely short because this is WhiteCoats’ blog and not mine.

By: ERP

ERP — Tue, 28 Oct 2008 14:32:39 +0000

I posted on this last week and got a slew of responses. Here is one of them:
I want to correct you where you have the facts wrong. The Supreme Court is not ruling on the merits of the specific case, of whether or not it was a medical error or a drug labelling problem, but on preemption, narrowly whether approval by the FDA preempts state law. And preemption currently is not the law of the land. If preemption were the law, then all of those affected by Vioxx would not have their day in court (which is the situation for those Vioxx sufferers who live in Michigan, where preemption has been the law for a decade). And ruling against preemption is not going to lead to a bunch of state based FDAs, since we currently don’t have preemption it will mean nothing changed. That said, many in the legal field feel that this is not the best case to rule on preemption, given that it is as much about a medical error as product labels.

Doug Bremner MD on October 24th, 2008

I am a little confused since I thought the Vioxx case was about soemthing completely different.

By: Med Student

Med Student — Tue, 28 Oct 2008 13:32:28 +0000

I’d be interested to know if there is any FDA-approved medication that hasn’t produced a complication more serious than gangrene in 1 out of every 50,000,000 administrations. I am not a fan of pharma by any means, but in this case it seems like this is clearly an issue of practitioner liability and not one of product safety.