Dear Nancy:
I'm glad you brought this up for discussion. We saw this case reported on the news several months ago, and her loss is so sad, and also so apalling. She is an amazing person in that she has risen above the situation. How can she ever overcome however, the feeling of "why" and "what if they had administered the meds correctly." It would be difficult to ever really overcome emotionally, especially because you are missing part of an arm, one of your most needed appendages to nagivate your daily routines and your career. Everytime you go to hug your child, husband or other loved ones, it is not the same.
However, I don't know how I feel about suing the pharmaceutical company since they issued fairly strong arguments AGAINST this practice. It is the Hospitals are doing a great disservice if their practices allow for administering Phenergan as an IV push (and other medications that should not be given IV) in the ER. It demonstrates very little regard for the best interest of the patient.
I have had IV pushes in our local ER although I argued while it was being done. It is done because it is less costly and is expeditious; less time that a patient occupies an ER "bed" and less time to administer the meds. They also no longer administer fluids to rehydrate from dehydration, but tell you to "go home and drink pedialyte". The hospitals are trying so vigorously to get people "out" as fast as possible for as little cost possible, but they are putting the patient at greater risk by doing so. It is difficult when you are in the throes of an unremitting severe migraine to have to argue with a healthcare provider, particularly since they are in control and will be "sticking you".
It makes me feel sometimes like I am up against ever-increasing obstacles. When I feel well I can fight, but when I am extremely sick I cannot. That is why supporting Headache Advocacy efforts is so very important.
Great SharePost, Nancy!
I have a problem with the Court's decision on this one. At the time of Ms. Levine's treatment, the label had very clear contraindications listed:
"Under no circumstances should PHENERGAN Injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene..."
and
"Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or unintentional intra-arterial injection. Reports compatible with unintentional intra-arterial injection of PHENERGAN Injection, usually in conjunction with other drugs intended for intravenous use suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances."
How much stronger could the warnings be???
Seems to me that the doctor who ordered the injection and the person who administered it are the people responsible for Ms. Levine's injury. It's reported that she settled out of court with the clinic for an undisclosed amount. Hmmmmmmm. Maybe I'm cyncal here, but did she go on to sue Wyeth because she felt that drug companies have deeper pockets?
How much research and development could Wyeth do with that $6.7 billion? A great deal. Why are we so quick to blame everything on the pharmaceutical companies? It's the pharma companies we in the U.S. keep expecting to do the research and development for new drugs and treatments.
Bottom line? Wyeth had very strong contraindications and warnings on the label. It was the responsibility of the clinic staff to know and heed those warnings. They blew it. The Court blew it with this decision.
Teri
I don't know if it is "deeper pockets," maybe she just wanted more people to "pay" the price more than she already is. This really is a no win situation for everyone.
How are medical professionals going to ensure that is doesn't happen again? I think this is a question that really needs to be addressed.
it could be that it was completely out of her hands who got sued. Usually theinsurance companies make those decisions on cases like this. Some times you have no choice. I'm sure she is so glad to have the lawsuit over with and not hanging over her head any longer.
thank you for bringing this up. I get this type of treatment done when i go the the ER for my migraines and have never even heard of this risk before reading about her lawsuit. So for that I am thankful. I will bring it up next time.
There wouldn't be an insurance company making the decision in this case - when you are sued, and have liability insurance, your insurer calls the shots. When you are suing, it's on you and your attorney to make the decisions. This certainly feels like a decision to go after the deepest pocket involved. I truly feel for Levine, and a really horrific error was made, but i agree that the warnings were as clear as could be. I don't see how the manufacturer could have done more to prevent this. And Teri is right, they could do a lot of research into new drugs with that money!
Another irony of this whole thing is that phenergan (promethazine) has been generic for so long that Wyeth, while the original inventor of the medication, was probably not even the brand on the shelves of that hospital. And I totally agree that they shouldn't be involved. It's like suing Sears for the swingset you bought there and then little Johnny breaks his arm when the swing falls apart.
Maybe the warning should be a "blackbox" warning, but if the med is given IV properly and not push, then it can still be used in appropriate circumstances. As a healthcare professional, I know I can make and have made mistakes and I always know that when I am not certain about something, I will look it up. I don't have a PDA but I've always had the internet and our "pharmacy bible" online where I've worked. Just today I called and faxed a doctor because I couldn't read his writing even though the other 2 folks told me what the drug was. Better safe than sorry in my book. I also make sure to keep my own personal liability insurance.
So I agree, yes it's a tragedy. Did the right outcome occur? Had I been on the giving end, I'd probably be a living mess for years, wracked with guilt and mad as heck that I'd been doing the same thing for years and never questioning the procedure (because I'm sure the person had). Would I ever do it again, probably not. BUT, if it's a common procedure, you can bet that it's happening right now in most hospitals around the country......
Diane
So
This Supreme Court ruling is tragic. Not only for Ms. Levine, but for all patients. Unless Wyeth wins on appeal, if there is such a thing for Supreme Court rulings, we will all pay for the settlement ($6.7 million). This could mean less research, higher prices, and more fear of being sued that leads to fewer prescriptions for effective drugs. Every drug has risks and I would like to think that every patient is aware of the risks of even requesting treatment.
In this case, exactly how Phenergan got into Ms. Levine's artery is not clear. Some reports make it appear that the person administering it was careless and injected it directly into an artery. Nancy's account makes it appear that it was an accident. Either way, Wyeth's warnings state clearly that interarterial injections can be accidental and not easily detected.
I vehemently disagree with the decision against Wyeth. It was a tragic accident. I think Ms. Levine's settlement with the clinic was sufficient compensation. Wyeth's warnings were adequate. I can't think of a better or stronger way to warn healthcare providers about the risks of accidental arterial injection.
Now, we may have even a bigger problem. In this case, a jury that was, most likely, not medically knowlegeable, decided that Wyeth's warnings were inadequate. This trumps the FDA. Will this set a precedent? How many more lawsuits against drug companies will this case spawn? I certainly can't afford even one more decision like this. What do the rest of you think?
Debbie
Hi Debby:
It does indicate a scary precedent, not only in the courtroom, but also in discouraging some pharmaceutical manufacturers from expanding usage (or developing) medications for migraines.
My husband is in pharmacy academia (has participated in running clinical trials) and says that this sort of action could make some manufacturers hesitant to seek new drug applications and/or conduct the expensive trials necessary to extend usage for drugs they feel that they are stepping into risky territority with regard to inappropriate "procedures or handling" with their drug and/or litiginous populations. It is discouraging. I wonder if there is some means with which this decision could be overruled.
It makes me angry that lady lost her arm. I was shocked I take phenergan and was in the emergency room with a stomach flu and they gave me fluids and an injection of phenergan. I take the phenergan pills at home when I get my migraines. It's ashame that this happen and I wish her all the best. I'll pray for her.
My 21 year old daughter was given a dose of IV phenergan while in the hospital for pneumonia. It was administered straight into her hep lock. She immediately complained of it burning and hurting and yet the nurse continued the push. My daughter immediately complained that something wasn't right. Her eyes rolled back in her head, her tongue hung out and her head fell back. I yelled for the nurse who came back into the room and looked at her and said"This isn't a NORMAL reaction for her?". I yelled no it wasn't and she asked me what I wanted her to do about it. I told her to get someone in there to help my daughter. My daughter became semi coherant and was clawing at her chest saying "Mom help me!". About 6 people from a crash response team came in. The ICU nurse asked me what happened and I told her. Her exact comment to me was that I was lucky she was still alive. My daughter spent 6 days in ICU and had to be given blood thinner shots for the blood clot that it caused. She was never the same again. After more hospital visits and doctor visits my daughters heart stopped on March 31, 2009 and she died. Cause of death ... a phenergan induced blood clot.
After her death I have been searching for answers. It seems that phenergan according to the FDA should not be given to patients with heart conditions and lung conditions. Both things my daughter had and that the hospital knew of.
I think that the patients and their families have the right to know EVERY possible side effect of a drug BEFORE hand so we can make better judgements on our families care.
As I understand it, the Supreme Court's decision did not state anything about the merits of the lawsuit, just that the federal law could not protect the pharm industry from liability suits decided at the state level.
The person who injected the phenergan onto the patient's artery is the one who made the grave error. As I recall from the story, this was done by a physician extender, and it was not deliberate or under the impression that it was safe to give it intra-arterially; he/she thought they were in a vein. It seems that the liable parties were the physician extender and their supervising physician. I strongly suspect that the patient's lawyers were not satisfied with the amount of money they could get from suing the two of them and went after deeper pockets, like any good lawyer would. The fact that these lawyers succeeded is what astounds me. I don't see how the drug company is to blame for what happened. It's analagous to suing Toyota because a drunk driver in a Prius ran into you. And does this woman need $6 million to get through life?? Hey, maybe I want an intraarterial injecton of phenergan!
Wyeth needs better defense lawyers.
An important and real question--how do we compensate people who have been irreparably harmed without punishing innocent parties or destroying guilty individuals who make an honest, though grave, error?
My name is Debbie and I went to the emergency room with a migraine that was causing severe pain and some nausea. I was administered phenergran by IV with the nurse pushing it through like you do a shot of pain killer like morphine. A few seconds later I had an acute distonic reaction and was totally violent and out of control to the point that 4 people had to hold me down and I was eventually put into a induced coma and kept in intensive care for 24 hours before my husband brought me home. I experienced severe short term memory loss and have suffered agitation and shakiness etc. I told the emergency department that I could not take compuzine and that I had become very agitated and tried to rip out a IV at another previous visit to an emergency room. My husband said the event was very intense and out of control and that he was afraid I was going to have a heart attack or something. Can anything be brought against the hospital or the pharmacutical company?
Featuring Content From:
By using this service, you accept our Terms of Use. Please read them. The consumer health information on is for informational purposes only and is not a substitute for medical advice or treatment for any medical conditions. You should promptly seek professional medical care if you have any concern about your health, and you should always consult your physician before starting a fitness regimen. Copyright © 2012 Remedy Health Media, LLC. All Rights Reserved.
My heart goes out to Diana Levine, and all others who have suffered injury due to this type of accident. Thank you for this important, and excellent, article, Nancy.
Thanks for reading, Lynn. It is indeed a horrific story. No one wins here, least of all Ms. Levine.