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Wyeth v. Levine

There have been a lot of opinions rendered about the Wyeth v. Levine lawsuit. Want to read all the briefs? Click here. Including amicus briefs, there are about 30 of them. You can also read more about the case at this NY Times article.

The case has been fought out in Vermont’s trial court and in the Vermont Supreme Court.

Now the case is pending before the US Supreme Court.

It’s a little odd when a drug company writes me to solicit my opinion. Last week I was invited to a conference call with several bloggers including TK from ER Stories and Michael Miller from Health Policy and Communications Blog along with one of the Wyeth representatives and a Wyeth attorney. Why did they want bloggers on a conference call about a pending Supreme Court case? They want to bring the facts and the issues to the public eye. Not sure why they picked me. Must be my charm …

Before I start down this road, I’m a doctor, I’m not a legal scholar (but I did stay at a Holiday Inn Express). I’m not being paid by Wyeth or anyone else to discuss this. Just doing these posts because I think the issue is important. I’m also relying on Wyeth for some of the facts since the case is complex and I don’t have the time to read all of the briefs in this case. However, as far as I know, the “other” issues have been decided and the remaining issue before the US Supreme Court is one of “preemption.” I’ve tried to get the facts correct, but feel free to correct me if I have made a factual mistake.

Today, I’ll focus on the history of the case and tomorrow I’ll get out my soapbox.

The story began when a musician named Diana Levine went to the Northeast Washington County Community Health clinic with a migraine headache and vomiting. She received intramuscular injections of Demerol (meperidine) and Phenergan (promethazine) and was discharged. Her symptoms weren’t controlled. In fact, she began vomiting more and returned to the clinic. In order to improve her symptoms more quickly, the physician assistant gave Ms. Levine IV Demerol and IV Phenergan. Ms. Levine didn’t have an IV established, so the PA inserted a “butterfly” needle into the patient’s vein and injected the medication.

Before I tell you about the outcome, you have to know a little more about the drug Phenergan.

Phenergan is approved for use by the FDA. I have previously commented how the FDA doesn’t exactly do the best job investigating medications. Just think, the FDA approved all those cough and cold medications that the pediatricians are now decrying as a public health threat. Well, actually, the pediatricians are just saying that everyone is too dumb to take them correctly, but that’s another story. According to Wyeth’s brief, Wyeth had ongoing discussions over the years with the FDA to make sure that the FDA felt that the labeling was adequate. Even if we assume that the FDA had no idea what it was doing when it approved Phenergan for use, during the conference call the Wyeth rep stated that more than 220 million doses of Phenergan have been given around the world.

Phenergan is an irritant. If you’ve ever gotten shots before, you know that some shots hurt like heck and that you can hardly even feel other shots. I commented in one of my previous posts that Phenergan produced “burning” sensation when it is injected into someone’s buttocks. The FDA has also approved Phenergan for intravenous use, and, just like the muscles, Phenergan causes irritation when injected into a vein. Therefore, when Phenergan is administered into a vein, the manufacturer recommends that it be administered slowly and recommends that no more than 25 mg be given at one time. Injection of Phenergan into the skin or arteries can cause serious injuries including skin necrosis and gangrene.

Back to the story ….

Ms. Levine got the Phenergan as an IV injection … at least that is what the physician assistant thought happened. Shortly after starting to inject the Phenergan, the patient started having pain in her hand. Severe pain. Very severe. She described the pain as the worst pain she had ever experienced in her life. The PA finished the injection and then realized something terrible. She had mistakenly given Phenergan into Ms. Levine’s artery. The medication traveled to Ms. Levine’s hand and the irritation shut down the blood flow to her fingers. Within days, Ms. Levine had developed gangrene in her hand and required an amputation of her hand and arm at the forearm.

Ms. Levine justifiably filed a lawsuit.

Her lawsuit named the physician, the physician assistant, and the clinic. All of those parties settled the case before going to trial. The other party to the lawsuit was Wyeth, the company that manufactured the medication that caused Ms. Levine’s injuries.

I don’t think that the allegations against the other parties are pertinent to the case, but one thing that I think was pertinent was the reported testimony of the physician in the case. I haven’t read the testimony, but one of Wyeth’s attorneys stated that the physician testified that if the warning on the medication had been stronger, he would have never ordered the medication to be given IV. The story then becomes an “old lady who swallowed a fly” argument. If the warning was there, the medication wouldn’t have been ordered IV. Then the PA wouldn’t have tried to give the medication IV. If the PA hadn’t tried to give the medication IV, the medication wouldn’t have been injected into the artery. Then the patient wouldn’t have lost her hand.

Even though Phenergan is approved as being “safe and effective” for IV use by the FDA, Ms. Levine’s attorneys argued that the product labeling should state that “no” IV use is allowed so that patients will never get gangrene due to accidental arterial injections. The medication just isn’t safe when given that way. Wyeth’s Supreme Court brief quotes the plaintiff attorney as telling the jury “The FDA doesn’t make the [safety] decision, you do.”

Wyeth argues that its extensive discussions with the FDA and the labeling changes it made in response to those discussions are sufficient to put the users of Phenergan on notice of the potential adverse effects. It also notes that out of 220 million Phenergan doses, there are 4 confirmed and up to 20 possible cases of gangrene associated with its use.

Do the FDA-approved product inserts amount to a “minimum necessary” standard which drug companies should then be required to supplement as Ms. Levine argues? Or are the FDA-approved product inserts sufficient by themselves to adequately warn consumers of potential dangers when using the drug as Wyeth argues?

If you agree with Wyeth, then the rulings by the FDA prevent (i.e. “pre-empt”) any actions by the state courts and Wyeth wins.

That’s where the battle lines have been drawn.

Tune in tomorrow for the rants.

No comments

  1. I’d be interested to know if there is any FDA-approved medication that hasn’t produced a complication more serious than gangrene in 1 out of every 50,000,000 administrations. I am not a fan of pharma by any means, but in this case it seems like this is clearly an issue of practitioner liability and not one of product safety.

  2. I posted on this last week and got a slew of responses. Here is one of them:
    I want to correct you where you have the facts wrong. The Supreme Court is not ruling on the merits of the specific case, of whether or not it was a medical error or a drug labelling problem, but on preemption, narrowly whether approval by the FDA preempts state law. And preemption currently is not the law of the land. If preemption were the law, then all of those affected by Vioxx would not have their day in court (which is the situation for those Vioxx sufferers who live in Michigan, where preemption has been the law for a decade). And ruling against preemption is not going to lead to a bunch of state based FDAs, since we currently don’t have preemption it will mean nothing changed. That said, many in the legal field feel that this is not the best case to rule on preemption, given that it is as much about a medical error as product labels.

    Doug Bremner MD on October 24th, 2008

    I am a little confused since I thought the Vioxx case was about soemthing completely different.

  3. I’m a Actuarial science/health economics major (read “bean counter”). In economics there is no such thing as a perfect solution only trade offs. Optimizing the utility of a given treatment is notoriously difficult given genetic variability. I have asthma and could tell you how much fun it was finding an inhaled steroid that works effectively. The more I learn the more I’m inclined to support a clinician handing someone a print out of the FDA warnings and placing the responsibility of weighing the risks between a patient and his/her provider. The premise being that if you don’t trust the judgment of your physician to advise you appropriately and lack the requisite mental capacity to make a decision you are likely in such bad shape that this won’t

    I, in principle, opt for individual liberty and personal autonomy whenever possible. No I’m not as naive as I may initially appear. This post has kept purposely short because this is WhiteCoats’ blog and not mine.

  4. I started commenting on this, but then it grew and grew and I decided not to take up all your space with my bloviating, so I gave it more space on my own blog. Go read my sleep-deprived opinion at my blog.

  5. I agree with the commenter from ERP’s blog that this case is not the best case to test preemption. If you read the plaintiff’s statements, she’s actually angry about the lack of properly informed consent; she feels that she wouldn’t have consented to the IV medication had she known that there was a risk of accidental IA injection with gangrene. Since gangrene is a rare but known complication of IV Phenergan, when given IA, she feels she should have been told of this. While it’s true that the Supreme Court is using this as a preemption case, it will have to be decided on the merits of this particular case, which aren’t very suited for this purpose.

  6. Wait a second Tiny Shrink, this danger (accidental arterial injection) exists with TONS of drugs. Are you saying we should have everyone sign consent for any drug we give them?

  7. ERP: No, I don’t think we have to sign consents for everything. My god, the risks of normal saline IV fluid, if you list them all out, including the BS hypersomatic reactions some patients get to every possible medication, would take all damn day. I wasn’t saying I AGREED with the patient, I was just saying I think her point would be better served by making an informed consent argument. Of course, she’s already gotten money from the people who actually made the mistake, and they’re the ones who provide informed consent, not Wyeth, so she (and her lawyers) wouldn’t have $$$ at stake from Wyeth if they built the case on informed consent.

  8. It’s taken me a while to realize that promethazine is given far more routinely than is appropriate. It’s a dangerous drug (although, IMO, more because of its sedating properties). It’s also a drug of abuse, and I have no idea why it’s not monitored by the DEA, while I have to count the Sudafed in my Pyxis twice every week.

    Look, the PA gave it wrong. We can’t hold drug companies accountable for every improperly administered dose. That’s not reasonable.

    At the same time, it wouldn’t be surprising to me to learn that the PA or physician involved was unaware of its vessicant properties. Can we actually expect every provider to know everything about every drug? Sure, that’s what we do expect, but it’s not realistic either.

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