Sorry... watching a 22-minute documentary on ANYTHING, let alone a (sad story about a) woman amputee, is not what I consider Friday-Fun! But, man, that really sucks.

I only watched the beginning few minutes, but she seems like an amazing person. Very great way to make a case.

Can't watch the video at work, but I imagine she's saying something like, "I had a headache THIS big". That expression kind of loses its meaning coming from her now.

My wife has said she'd give and arm and a leg to get rid of the pain when she's having a migraine, but I think she'll quit saying that when I show her this.

I hope Diana wins.

@dorianh49:
Too bad it didn't have Excedrin written all over it.

I lost a small claim suit for $5000 a month ago -- it wasn't any fun, and still bugs me now and then. But after seeing stuff like this, I feel much less bad.

I started reading this as I took my daily Phenergan pill. I realize that the problem is with a bad injection and not the pill, but for a moment it was fairly difficult to swallow. (And that pill tastes nasty.)

Why does Luis Guzman have a cameo in this documentary?

@Xerloq: Yeah seriously. Sometimes I feel that way when I have a migraine but.. I don't think I'll say that again.

I hate to side with a pharma company, but I'm not really sure it's anyone's fault in this case. It certainly sucks big time, and she should be compensated somehow. But I wouldn't make Wyeth out to be a villain in this case.

This documentary made me more angry at the woman than the company or doctor.

Extremely troubling, and not only becuase of Diana's tragedy (she also can't work now, since she's a guitar player/musician). I can't watch the video at work, but I've been following for a while, and - if I understand it correctly - a ruling in Wyeth's favor could have huge ramifications for consumers & producers of anything federally regulated or registered. If you're injured by something the fed has officially 'signed off' on, you wouldn't be able to demand compensation from the company, since they submitted whatever it was to the govt and it becomes whichever agency's responsibility.

I'm not sure if in that case the govt agency would be liable.... it seems like it would make consumer protection a lot more complicated. And worse. It seems that lawsuits are more effective and costly than regulations and fines.

@oneandone: Didn't mean to respond to you directly Marshfield - sorry for the miss-click.

What happened to her no doubt is horrific, but it is completely unrealistic to expect that every patient is informed of every known side effect of a drug before being administered one. It never fails to amaze me when people are surprised that drugs have side effects, sometimes nasty ones. And you know, promethazine IVPush is probably given 10s of millions of times in hospitals with almost no serious adverse effects.

Also, the intro is not correct - the drug did not "[seep] out of the vein into an artery." Whoever got IV access on her initial cannulated a damn artery. If they had cannulated a vein like they were supposed to, this never would have happened. Blaming the drug for causing a problem when the drug was clearly used incorrectly is a bit bothersome. That's like saying my blender chewed my fingers off when I stuck my hand inside it while it was running. The hospital/nurse/etc are primarily responisble for this error, not the drug company.

This marks the first time in my professional career that I'm defending the drug companies!

Dan, Diane's wife, quietly offers his gods a quick prayer of thanks for his refusing the nurse's offer of a migraine-reducing shot applied to his groin area.

John Redcorn FTW

@nsv: Yuck. Even if it only happens with intravenous injection, I'd DEMAND my doctor give me something else. That's just me tho.

@mgy: He lives in the town next to Diane. I grew up in the same town, her daughter is friends with my little brother, and I spent a good amount of time with Diane when I was younger. This is a sad story and I hope some good can come of it. It's a tricky situation here with the label policies, but the pharma companies are basically saying that once the label is approved they shouldn't need to be changed. I don't think that should be the case...clinical trials can only cover so much.

@changed my name: Exactamundo. At least she has a good head and shoulders. (What is this, 80's commercials day? Bye. I think I'm going to do some Toyota jumps while whispering "Phil n' Jim's" now)

I've heard that the FDA is markedly easier to get stuff thru, due to changes to make things more industry friendly and "efficient". I wonder how these changes over the past 8 years have impacted risky drugs getting to market, and if perverting the FDA's mission in such a fashion means there's more responsibility for the drug manufacturer than in the past.

@MBPharmD:

I agree 100%. This is NOT the drug companies problem. I suspect that the IV site had infiltrated and not that an artery had been cannulated.

The problem is, the drug company has deeper pockets than the nurse the pushed the drug without checking to make sure the IV site was still good.

My thinking's the same as MBPharmD on this one. As much as I distrust big pharmaceuticals who mark up the drugs ridiculously, and the bad companies who often will push a dangerous drug on the market before approval, it's not Wyeth's fault here. There's even a company in this video that is blamed for bad labels, big time their fault. But here it seems that they're somehow trying to pin the blame on the drug company.

The effect was known. Gangrene = amputation. Her doctor acknowledged that he knew about the effect. If she had any other drug or even saline, it could also 'seep out' (which seems more like a bad excuse) if given improperly. It sounds like it wasn't properly checked that it had been administered to the vein.

There's no surprise she's after the drug company though. She wants one thing now: money. Compensation. Can't say I blame her, I'd be pissed if I lost an arm, but her doctor doesn't look like he's rolling in dough, so her lawyer likely suggested they go after someone with cash.

"I've heard that the FDA is markedly easier to get stuff thru, due to changes to make things more industry friendly and "efficient"." As someone who works in this industry, I assure you that you have no idea what you are talking about. There is nothing "easy" about drug approval at the FDA. Period.

@Trai_Dep: Not at all in this case, Phenergan was approved in 1956.

I would insert the link but I'm html-challenged - Google "FDA CDER" and continue from there.

@dougp26364: I was pretty sure I read that the provider inadvertently cannulated an artery but I can't find it and I could be wrong. They could have blown the vein, instead, as you're suggesting.

Another interesting twist is that Wyeth doesn't even make Phenergan anymore, it's only available generically. But of course, like you said, who's got the $$$$$$?

It comes with the drug's territory; I've given IV Phenergan hundreds of times with absolutely no adverse side effects other than a little tingling in the veins. It isn't the only drug in the world that can be caustic to veins, so are we going to go on to ban all drugs that are? IV Dextrose, basically sugar water, that is used in emergency situations for low blood sugar, is the same way, do we ban that too?

This has NOTHING to do with the drug and everything to do with the fact that the nurse thought she was hitting a vein and instead hit an artery. Veins go back to your heart to be absorbed, whereas an artery in your arm would go to your fingertips, then back up to the vein and heart. Any moron that's started an IV should be able to instantly tell that they're inside a vein instead of an artery, and if they can't then they deserve to be sued.

Bottom line: If you're a sue happy prick, at least sue the right people.

@RudeandRude: What's your beef with her? Do you hate the disabled or something?

What the **** is in this stuff that would cause an arm to become necrotic? I guess it works though, because you're not going to care about your migraine anymore if your arm is falling off.

@oneandone: consumer protection will be "a lot more complicated" if Diana wins. If she wins, that means that when a drug company is putting warnings on their drugs, they can't just use the warning that the federal government has approved. They have to figure out what the courts in each state think a good warning would be. Do they design different packaging for each of the 50 states? Do they combine all the different warnings and distribute a paperback book with each bottle of medicine? And every time a consumer sues, and wins, they have to update the warning again to match what the court in the latest case thought the warning should have been.

Your medication is going to be a lot more expensive if this woman wins.

The issue in this case was not that the drug itself causes a problem in particular, but rather that the healthcare provider attemped to access a vein in her upper arm and instead hit the artery. This is a twofold problem:

1. Arteries don't react well to trauma because they're programmed to clamp down to prevent blood loss.

2. There's one main artery in that part of the arm, so trauma to it (and the secondary constriction) causes lack of blood further down the limb. This anatomical issue is why most clinical providers don't routinely attempt to access veins in this region.

The person who should be sued isn't the drug company but rather the provider who used poor technique to disasterous consequences.

@tc4b: Medicine isn't like mathematics. There's always a risk. If you ask doctors to be responsible for the risk, then they will charge everybody more.

That's how social insurance works. Either shit happens on occasion and you deal with it or everybody goes poor giving money to everybody else because shit happens.

So, that said... if she knew about this complication and didn't tell her doctor... it's not her doctor's fault. If she didn't know about this then that just sucks and I feel bad for her, but I don't think it's the doctor's fault. It could be the pharma's fault, but it'd have to be shown that a great enough percentage of people who get this injected have complications to warrant putting a warning label on there. And even then it's just a "hey, know the risk!" type of thing and not a ticket to free monies.

@rtmccormick: If you're a sue happy prick, at least sue the right people.

Yikes! I've had that several times and nobody has ever mentioned that as a possible outcome!

@Tightlines: Yeah, what the fuck is she complaining about? "Ooh, I lost an aarrrrmmmm." Big deal. You got another one, get over. I'm with you, comrade rtmccormick! If we don't speak the truth, who will?

/sarcasm

@vespolina: Wrong. They'd most likely figure out the requirements ofthe states that require the most stringent guidelines and apply them to other states.
The WHOLE idea of warning labels is laughable anyway, since manufacturers submit their own labels for approval, the feds can only really suggest warnings...

@MBPharmD: You're missing the point of the lawsuit...

The drug company knew that this was an issue with this specific method of delivery and did not notify providers of the warning. Had the patient been told there may be a risk of losing her arm, I doubt she would have ever accepted the drug. Whether the nurse did not do the proper set up or not is irrelevant, since the nurse did not know the possible complications as well.

@rtmccormick: This is ridiculous that you'd refer to the plantiff as "sue happy." The patient was never advised of a documented risk that the drug company knew about. And the fact that there are other more safe methods to use this drug means there is no reason to use this specific method and risk the complications associated with it.

@rellog:

If the provider failed to correctly access the vein and use proper injection methods, the fault is not with the drug company.

Did the clinician verify they had good access to the vein or is this condition something that is exclusive to phenergan?

Like MB said thousands of phenergan injections are given each day and this is the first we hear of a gangrene complication.

If anyone has seen an packet insert for these drugs there are tons and tons and tons of risks listed. Some of which only occur in 1% of patients and are there to reduce risk to the drug company.

This sounds like an isolated incident in which this woman should be compensated in some way, but I don't think shifting the blame to Wyeth or the FDA for that matter will rectify the problem.

@rellog: No patient is ever going to be told something like that in a way that they will be discouraged treatment. At best they would get a piece of paper with the risks. Doctors are not going to tell people of the worst possible obscure side effect as if it's guaranteed to happen, no one would take medication.

@jimv2000: It's usually given for nausea and vomiting and like other staff members have said before most drugs are hard on the veins, but their benefits outway the risk.

Having a necrotic arm is not typical to the 10,000+ injections given every day.

many american boys go in to the hospital to be born, but come out missing part of their genitals, why isn't their outrage there as well?

I got an injection of this stuff when I was in college, but they shot it into my glute instead of my arm. The nurse said "it's pretty caustic, so we use a bigger muscle to avoid damaging a smaller muscle like the ones in your arm and shoulder."

It fucking BURNED going in, holy crap. I've never had a shot hurt like that before. I can see why it could cause major problems if it were injected improperly.

The good news, I guess, is that I finally stopped throwing up, and the nurses at the student clinic gave me juice boxes since it can also cause drymouth.

@rellog: "The WHOLE idea of warning labels is laughable anyway..."

Yeah, also considering that a lot of people don't even get exposed to the warning labels. Docs very rarely get informed consent before giving drugs because the docs themselves haven't read the package inserts.

Regardless of who's fault it was (*cough* whoever gave her the injection *cough*), how in the world did she lose an arm from gangrene??? She and her doctor had to have both been absolute morons to not catch gangrene in time to save the arm.

That said, sue the doctor, not the maker of the drug that was wrongly administrated.

@larsitron: I think that was the issue, but now it's become a new issue - federal pre-emption, and whether or not federal regulation of a drug (or food, or pesticide, or whatever) waives the manufacturer of liability for injury caused by that drug.

The nurse (and I think the clinic) were sued by this patient and lost, but now it's morphed into something else, which is unfortunate.

@vespolina: I agree, either way it ends up more complicated - but if Wyeth wins, I think it results in less consumer proection, assuming that federal inspections, enforcement, and regulation continue to be what they've been. I'd much rather have a paperback book outlining the risks of every medication than have no recourse after being injured by something that at some point passed through federal regulatory channels and thus required no corporate responsibility.

The paperback book would be ridiculous, but imo it's the preferable outcome. The ideal outcome would be if this had never gotten to the court, because there's no way it can end well.

The story is a bit low on details...

1) What was the % of gangreen incidents in clinical trials? .1%? 1%? .00001%? 10%? It makes a huuuuge difference how many other people experience in terms of whether its reportable to the patients using them. Just because one person had a bad reaction to it doesn't mean every single patient needs to be informed. But, if it was a large enough percentage, then yes the doctors and patients should be informed.

2) I'm going to assume the doctor wasn't sued because it was determined he did nothing wrong. But then again its a little vague and who knows what really happened. Based off this story there is no proof whether the drug is actually dangerous or was just administered wrong.

There's 3 possible situations here... 1) the doctor/nurse adminstered the drug wrong and should be sued 2) the drug company knowingly concealed a bad sideffect that was statistically significant and should be sued 3) she just got really freaking unlucky and was part of that .01% of people who react badly and she's out of luck. Not every single case of medical cases gone wrong has proper cause for a lawsuit. Doctor's and medicine isn't infallible, sometime crap happens and its not anyones fault. Everyone single procedure, no matter how minor, has potential negative consequences outside the control of the medical staff.

There are several drugs that will cause necrosis of the tissue if the IV infiltrates, like Nipride. Any doctor or nurse should have flushed the IV prior to administration of the medicine to make sure that the line was still patent. What happened to this woman was a tragedy, but it is not really feasible to list every single side effect of every single drug that you have ever taken/been given.

@dougp26364: @larsitron: Actually the doctor/clinic/insurance company associated with wherever the thing was done, already settled out of court. She's taking on the Pharm company because the warning label that the doctor didn't read anyways didn't say..."BTW if you fuck up with the iv push your arm will fall off"

@Oranges w/ Cheese: I have something that works, and it can't cause what we see here. It doesn't seem like a good idea to give up something that works to try other things that might not work or that might have far worse side effects.

If she took a pill and had this happen, I'd be on the phone right now. But dumping the pills would be like refusing to drink water because people drown in it.