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Drug 'Label Is No Shield'
Old 03-04-2009, 02:56 PM   #1
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Drug 'Label Is No Shield'

I'm no fan of the prices big pharmas charge for some drugs, but this action against them seems a bit extreme. If they get FDA approval for a drug, they have warnings on the label as to risks, the patient takes the drug under doctor's care, why should the pharma be sued for the statistically rare bad reactions? Why should anyone be sued? Oh, yeah, because there's lawyers... (with respect to the good lawyers on this board )



Supreme Court Tells Drugmakers 'Label Is No Shield'

WASHINGTON, March 4 -- FDA approval of a drug and its label does not shield its maker from lawsuits brought by patients injured by use of the drug, according to a 6-3 decision today by the Supreme Court.
The ruling upholds the $6.7 million awarded by a Vermont jury to Diana Levine, a musician who lost her arm when gangrene developed following injection of the antinausea drug promethazine (Phenergan) by IV push.


http://www.medpagetoday.com/PracticeManagement/Medicolegal/13120
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Old 03-04-2009, 03:22 PM   #2
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As usual there is more to the story

At issue was a lawsuit by Vermont guitarist Ms. Levine, who lost an arm to gangrene after Wyeth's anti-nausea drug Phenergan was inadvertently injected into one of her arteries during a push IV injection. Ms. Levine had gone to a clinic for treatment of a migraine headache.
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Old 03-04-2009, 03:27 PM   #3
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Don't know about the case you cite, but sometimes pharmas publish their warnings as required, but then market the product with the "spin" that suggests it has a much broader indication than it really does.

Read the Ambien ads which would make you think everyone needs it. Then read the fine print in the PDR. So the label may communicate one thing while the marketing implies otherwise.

Another favorite of mine is some of the statin ads. Big headlines: REDUCES RISK OF HEART ATTACK BY 40%. What they really mean is that it reduces the annual risk (in very high risk patients such as those who already had one) from 2% to 1.2%.

I certainly agree with you that just cause something bad happens does not automatically mean someone should get sued.
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Old 03-04-2009, 03:36 PM   #4
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At issue was a lawsuit by Vermont guitarist Ms. Levine, who lost an arm to gangrene after Wyeth's anti-nausea drug Phenergan was inadvertently injected into one of her arteries during a push IV injection. Ms. Levine had gone to a clinic for treatment of a migraine headache.
But wouldn't that point to liability on the part of the provider and not the drug maker?
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Old 03-04-2009, 03:49 PM   #5
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But wouldn't that point to liability on the part of the provider and not the drug maker?
Deep pocket theory.
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Old 03-04-2009, 04:00 PM   #6
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I'd need to read the full court transcript to understand the arguments of both sides. Plus the inferior court decisions. As RiT noted there is a gap in approved use, marketed use, off label use.......

An awful lot goes into the supremes decison...me no lawyer, nor a public advocate. At times just curious. Am positive that reporting is always biased.
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Old 03-04-2009, 04:13 PM   #7
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I kind of agree with the decision... if the drug did the damage and the firm knew about the problem but did not advise anyone that it was dangerous.... well..
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Old 03-04-2009, 04:37 PM   #8
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I kind of agree with the decision... if the drug did the damage and the firm knew about the problem but did not advise anyone that it was dangerous.... well..
Here's all the bad things that can happen if you take this drug:
Phenergan Information from Drugs.com

Granted, you find a similar list with any drug, and a lot of it is CYA. But, if I read the case correctly, this was not directly related to the drug, but to a (hopefully rare) problem when it was administered, and the drug went directly into an artery. As Rich noted, this might be a question of who has the deepest pockets, but in a broader sense, maybe we need to accept that for the sake of a million people helped by a drug we may have to suffer 2 of 3 unfortunate errors, bad reactions, or whatever. OTOH, I suppose if I was the one hurt, maybe I would think differently.

Revealing my age (63), I recall the polio epidemic of the 1950s, and how some people got polio from the first vaccines. Maybe there were lawsuits back then, but I don't recall any.
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Old 03-04-2009, 04:46 PM   #9
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I kind of agree with the decision... if the drug did the damage and the firm knew about the problem but did not advise anyone that it was dangerous.... well..
I think the decision is ridiculous. The drug was injected into an artery. I am sure that was not SOP.

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Old 03-04-2009, 04:49 PM   #10
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I kind of agree with the decision... if the drug did the damage and the firm knew about the problem but did not advise anyone that it was dangerous.... well..
But if a drug wasn't used as indicated, how is that the drugmaker's fault?

The drugmaker can't list all the possible ways its product can be potentially abused. NO product maker can. It can list what the drug IS indicated for and in what doses. It can list conditions where it's known to be contraindicated. It can list known adverse drug reactions.

If it was not something designed to be given through the artery for migraines, it seems like a stretch that the drug maker should have specifically listed that (along with a million other ways it could potentially be misused) in the drug's product information.
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Old 03-04-2009, 04:52 PM   #11
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But if a drug wasn't used as indicated, how is that the drugmaker's fault?

The drugmaker can't list all the possible ways its product can be potentially abused. NO product maker can. It can list what the drug IS indicated for and in what doses. It can list conditions where it's known to be contraindicated. It can list known adverse drug reactions.

If it was not something designed to be given through the artery for migraines, it seems like a stretch that the drug maker should have specifically listed that (along with a million other ways it could potentially be misused) in the drug's product information.
Right, like "don't pound the needle through the skull and inject directly into the brain". Or, "eyeball injection may cause blindness". Maybe I could have future writing more inclusive drug inserts.

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Old 03-05-2009, 01:09 AM   #12
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Take a look at a step ladder next time you are at Lowes or Home Depot. They're running out of room to put warnings on the things! But like Ron White says "You can't fix stupid!"

Many adverse drug effects are due to improper administration and this can be as simple as giving too much or too little all the way to taking an improper history - a Dr. prescribed me an antibiotic to which I was allergic. I knew better and told him about it. The info was even in my records. Yet, I could have sued the drug mfg. and probably collected something - if nothing else, just to limit their cost of defending the suit.

Could be part of the reason drugs are so expensive. Naaaahhhh! It's the greedy drug makers.
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Old 03-05-2009, 08:51 PM   #13
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The Wyeth decision was actually made on a very narrow legal question -- do the federal FDA labeling regulations preempt state tort law? Under our system of government, there are dual sovereigns -- the federal government and the state government. Both are entitled to enact and enforce their own laws. Under the case law interpreting the "supremacy clause" of the Constitution, state law is "preempted" by federal law if a) Congress expressly says so in the federal law; or b) Congress has "occupied the field" by comprehensive federal law or c) it is impossible to comply with both state and federal law at the same time. In this case, the Supreme Court found that there was neither express nor implied preemption, so that the plaintiff could therefore assert a negligence claim under state law. The decision follows the trend of other recent Supreme Court cases that have held against defendants' federal preemption arguments.

So, while this may offer us all an opportunity to express our opinions about the general topic of medical malpractice liability and tort reform, it is important to keep in mind that the main point addressed by the Supremes is only tangentially related to the topic (as such decisions often are).

Here is the link to the opinion itself http://www.supremecourtus.gov/opinio...df/06-1249.pdf
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Old 03-05-2009, 11:52 PM   #14
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I believe the plaintiff's argument was that Wyeth knew about the danger of the push IV injection hitting an artery and causing gangrene, but didn't include a reasonable warning of the effect. The reasoning was that the FDA label was the floor of the warnings, and that the manufacturer had the best opportunity to know the various dangers and to warn of them even after FDA approval. The medicine was administered in a way that had potential for serious side effects with knowledge from the company, but without effective warnings. And this wasn't a rare bad reaction, this is the reaction that anyone would get if they had the drug injected into an artery.

Imagine going to the doctor for a migraine, getting an injection, getting incurable gangrene in a couple of hours, having your arm cut off (she was a musician), and then finding out the drug manufacturer knew about the problem but didn't include a warning about it. Tell me with a straight face you wouldn't sue.

I'm no fan of the Supreme Court these days, but I think they got this one right. And for once the decision wasn't 5-4 partisan based.Had there been a warning the provider could have just used a different delivery method with no real chance of the bad reaction.
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Old 03-06-2009, 12:09 AM   #15
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I believe the plaintiff's argument was that Wyeth knew about the danger of the push IV injection hitting an artery and causing gangrene, but didn't include a reasonable warning of the effect. The reasoning was that the FDA label was the floor of the warnings, and that the manufacturer had the best opportunity to know the various dangers and to warn of them even after FDA approval. The medicine was administered in a way that had potential for serious side effects with knowledge from the company, but without effective warnings. And this wasn't a rare bad reaction, this is the reaction that anyone would get if they had the drug injected into an artery.

Imagine going to the doctor for a migraine, getting an injection, getting incurable gangrene in a couple of hours, having your arm cut off (she was a musician), and then finding out the drug manufacturer knew about the problem but didn't include a warning about it. Tell me with a straight face you wouldn't sue.

I'm no fan of the Supreme Court these days, but I think they got this one right. And for once the decision wasn't 5-4 partisan based.Had there been a warning the provider could have just used a different delivery method with no real chance of the bad reaction.
IV means intravenous. That means, inject into a vein, not an artery. If you stick a needle into an artery blood will come pulsing into the catheter. That means stop, do not pass go.

It's seems odd to say that administering an IV drug into an artery isn't a result of operator error, rather than an inherent flaw in the drug. I suppose that a drugmaker might figure that most anything might be done with their drug, or it might be administered by unslkilled, distracted, or drug impaired practioners. The only answer to that is don't make powerful drugs, or at the the least only market them for life threatening or dire illnesses.

Here is what appears to be a good discussion of the case and some of its practical implications.

However narrow or broad the reasoning might have been, you can bet that the plaintiffs' bar will push it to the max, in court and in congress.

http://www.kaisernetwork.org/daily_r...fm?DR_ID=55364

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Old 03-06-2009, 12:19 AM   #16
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It's seems odd to say that administering an IV drug into an artery isn't a result of operator error, rather than an inherent flaw in the drug.
Only if you assume I know what I'm talking about, which isn't a good assumption. Still, if I went to a doctor and he was going to give me a drug that said on the label that if it goes into an artery my arm will have to be cut off, I'd probably take more aspirin instead. However, if it didn't say that on the label, and I lost my arm, and it turned out that the manufacturer knew about the issue, I guarantee I would be in court. And I hate the legal system and the litigious tendencies of our society. And I bet you would too, in the same situation. Just guessing, though.
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Old 03-06-2009, 12:28 AM   #17
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Only if you assume I know what I'm talking about, which isn't a good assumption. Still, if I went to a doctor and he was going to give me a drug that said on the label that if it goes into an artery my arm will have to be cut off, I'd probably take more aspirin instead. However, if it didn't say that on the label, and I lost my arm, and it turned out that the manufacturer knew about the issue, I guarantee I would be in court. And I hate the legal system and the litigious tendencies of our society. And I bet you would too, in the same situation. Just guessing, though.
You make good points. I would like to see the package insert. Maybe tomorrow I will hunt around the web to see what I can find.

The following statment is taken from the Kaiser article cited above. The Phenergan label, which FDA approved, includes a push IV injection as an option for administration but warns about risks associated with the practice, such as gangrene.

Here is a VA Bulletin which suggests that cases are rare, but also suggests that if it is administered incorrectly (including into the tissues around the vein), bad stuff including gangrene can happen. It appears that the VA while not prohibiting IV usage is also not very keen on it.

http://www.pbm.va.gov/vamedsafe/IV%2...10,%202006.pdf

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Old 03-06-2009, 07:22 AM   #18
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So, while this may offer us all an opportunity to express our opinions about the general topic of medical malpractice liability and tort reform, it is important to keep in mind that the main point addressed by the Supremes is only tangentially related to the topic (as such decisions often are).
Thanks for the legal slice and dice. So what you're saying is, the SC decided to not intervene in the lawsuit that was brought in a particular state, and the plaintiff could therefore proceed with a negligence claim under state law.

I understand what you said about the SC case not being directly about medical liability but, by allowing the plaintiff to proceed under their state law, doesn't that set a precedent for other similar lawsuits in other states? If so, isn't this tantamount to a medical liability ruling?
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Old 03-06-2009, 10:58 AM   #19
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Thanks for the legal slice and dice. So what you're saying is, the SC decided to not intervene in the lawsuit that was brought in a particular state, and the plaintiff could therefore proceed with a negligence claim under state law.

I understand what you said about the SC case not being directly about medical liability but, by allowing the plaintiff to proceed under their state law, doesn't that set a precedent for other similar lawsuits in other states? If so, isn't this tantamount to a medical liability ruling?
What I saw on TV news was what Gumby said... state vs federal... not the case itself.. the company was trying to say that the FDA says what goes on, or does not go on the warning label and the company can not change that warning... so the state can not hold them liable because that could NOT warn you...

I think the case has been decided and money awarded... I do not know if they have used all their appeals in the state, but you would think they had before they went to the Supreme Court....
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Old 03-06-2009, 11:37 AM   #20
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I got messed up by a capsule (pamelor) script for maintenance a few years back. I always filled this antidepressant at the same local pharmacy, no side effects, everything ok for many years.

Until I started feeling very weird, disoriented, dizzy, about to pass out, etc. Couldn't figure out what was wrong, so went by trial and error, suspecting it was my drug. I took the new script I had to another pharmacy, filled it, then simply took the pamelor as prescribed, symptoms went away within a few days. Thus something was wrong with old script.

I contacted FDA field office, gave them lot and box number of script and told them to go to pharmacy to check it out. I was too embarrassed to go back there and started with another pharmacy.

FDA did nothing. I contacted them a year later, they found file under pile of other files and did investigation, nothing happened. From what someone told me, it was either an outdated drug, a tainted drug or who the hell knows what they put in the capsule.

Bottom line is that FDA is not your watchdog, you can easily be poisoned, and I have no idea whatsoever what I was ingesting, and what damage I may even have due this fiasco.

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