Wyeth, Drugmakers Lose as Top US Court Allows Suits - after phenergen/gangrene suit case

[WillYourVoteBCounted]

Its not known what impact this will have on claims that Pfizer Inc. and GlaxoSmithKline Plc should have done more to warn that their anti-depressants might cause suicidal tendencies.

Wyeth, Drugmakers Lose as Top U.S. Court Allows Suits

Bloomberg News By Greg Stohr

March 4 (Bloomberg) -- The U.S. Supreme Court ruled that patients can sue drugmakers for failing to provide adequate safety warnings, upholding a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.

The justices, voting 6-3, said that pharmaceutical companies aren’t shielded from suit by the Food and Drug Administration’s approval of a treatment and its packaging information.

...The ruling is a victory for Diana Levine, 63, a children’s musician who says Wyeth should have warned against the injection method that caused gangrene in her right arm.

...U.S. drug-approval law bars state rules that create a “direct and positive conflict” with federal requirements.

The administration of former President George W. Bush backed the industry, arguing that jury awards can interfere with the FDA’s work by forcing drugmakers to exaggerate some dangers.

....

[uppityperson]

1. Reading the link, I'd go after whomever gave the med.

Doing IV meds, you need to be careful since if they don't go into the vein they can cause serious problems like this.

[Heddi]

3. yeah, I'm not sure how the Pharm Co is liable for an RN giving a med incorrectly

When we pull Phenergan from the Pixys, there is a HUGE note that Phenergan is a vesicant, that it must be diluted in minimum 10ml Normal Saline and must not be given faster than 25mcg/min or something. The vial that contains a single dose also has a "vesicant warning" on it as well.

The first thing we were taught in RN school re: IV meds was (and I don't kid) that PHENERGAN IS A VESICANT!!! Do not give it straight, give it as close to the body as possible (larger veins), stop the infusion IMMEDIATELY if the pt complains of burning during IV administration, and notify pharmacy and the MD ***IMMEDIATELY*** if there are any signs of infiltration after IV administration.

I'm not sure why the drug company is liable, unless (and this isn't made clear in the article) the vesicant warning and need to dilute was not made clear on the bottle, or instructions weren't given to the Pharmacy/hospital/RN that it is a vesicant that must be diluted.....

And on edit---there are TONS of IV meds that can cause the same problem because they are vesicants. I think either Calcium Gluconate or Calcium Chloride---can't remember which one---but there was a pt at a hospital I worked at who had to have their hand amputated because the Ca IV was given in a hand vein (should be given in large vein), the IV infiltrated and wasn't noticed until the IV infusion was done and the IV pump beeped, the RN noticed but even at that time (approx 30 min to an hour later) it was too late to save the hand.

[uppityperson]

4. I started to IV push an infiltrating vesicant med once

Person ended up with a gouge out of their elbow. Giving a med wrong is an error of the person giving the med. The person who got hurt needs to go after that person. I don't understand why the drug company would be liable unless there wasn't a warning given, a cya thing.

[Jim__]

5. Just based on the article, it sounds like the award from the pharmaceutical company was ...

... based on inadequate safety warnings on the package. It sounds like their appeal was claiming that since the FDA approved the drug and packaging, the pharmaceutical company couldn't be held responsible. The Supreme Court ruled they can be, and my guess is that a jury was convinced that the safety warnings were inadequate.

[Orrex]

2. Wait a minute--I'm confused

What happened to the government-wide conspiracy to protect Big Pharma?

[pnwmom]

10. Obama took office in January. n/t

[flyingobject]

6. So Wyeth fracked up on piss poor safety "warnings"

Then frack them. A violinist had to lose her arm before Wyeth had to take
responsibility.

How many regular people had to get fracked before it came to this?

[semillama]

7. Why don't you go find out and then come back and tell us?

Now, do your research well. We want to see statistical analyses, bar charts, and a list of "regular" people that got "fracked" - whatever that means.

Be thorough and devote all your time to it, why not?

[flyingobject]

9. here's all you need to know

FRACK

[uppityperson]

8. Why do you put "warnings" in quotes?