Migraineur Wins Phenergan Lawsuit

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. 

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

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

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?