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Wyeth Takes On Diana Levine And Preemption Issue In U.S. Supreme Court Case

Posted by Jane Akre
Friday, August 15, 2008 9:24 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Preemption, Dangerous Drugs, Tort Reform, FDA and Prescription Drugs, Product Liability, Drug Products, Diana Levine

Levine case to go before the U.S. Supreme Court.

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IMAGE SOURCE: Diana Levine in recording studio of Charles Ellers/ Courtesy: Diana Levine & Charles Ellers Studios

 

Interview with Levine, August 15, 2008

Musician Diana Levine is at the center of a case that has implications for everyone who has ever taken a prescription medicine.

On November 3, her case goes before the U.S. Supreme Court, brought by drug maker Wyeth. It will test whether corporations have blanket immunity from lawsuits when their product is approved by the government, something called federal preemption.

The case for and against federal preemption is covered in a previous story on Levine on IB News.

The approval in this case came from the FDA for a drug Levine was given in the emergency room in April 2000.

When she went into the ER for treatment of a migraine, in addition to a medication to treat the migraine she was given another medication called Phenergan made by Wyeth to stop the nausea. 

It was delivered by an IV push that injects the drug through an existing peripheral IV line. Previously during hospitalizations she had received the drug intramuscularly through a shot in the butt.  

Today she wishes she had stuck with the nausea.

The label for Phenergan does not indicate it can be administered by IV push. In the hospital, Levine was still in pain. Eventually doctors removed her hand because of gangrene. In a second procedure they took the right arm up to below the elbow. She has a prosthetic arm now, but making music became difficult if not impossible. 

Many people think when you win a lawsuit you are transported to easy street. But for many such as Levine, the money goes toward ongoing medical expenses.  To date Levine has not seen any of her jury award of more than $6 million that resulted from her lawsuit against Wyeth. But that doesn’t stop the medical bills, many of which she says are past due.

Amid the lawnmower and dog barking, Levine spoke to IB News from her home in Marshfield Vermont.

IB News:  What’s your life like since this happened?    

Levine: “I’m doing okay now and yes, I have to go to checkups with the surgeon and have appointments for prosthetic replacements.  Since I’ve not received the award I have past medical bills. It’s not a jackpot; life is not like since before it happened.”

IB: Are you able to get back to your music?

Levine: “As far as music I thought I’d never again write songs, I was sure I had post traumatic stress. Finally a shrink I was seeing said “write a song” or you’ll never get further.  Little by little I’ve had to recreate my identity as a musician, not as instrumentalist, but I began to collaborate. I used to be a prolific songwriter and I’m back to writing, not like the old days where at midnight I’d write a song, but I’m needing to still write, just at a more modest pace. Periodically, when I perform I hire an accompanist."

“It took me thirty years and I thought I was on the path, I had found my profession, I found my gift.  Who would have thunk it.”

IB: Now you’re making a difference in a whole different way?

Levine : “It’s just unbelievable, people have been hurt before me, but it becomes fairly obvious that this basically is being used as a case for preemption. It’s so obvious Wyeth needs to do the right thing so this can’t happen to anyone else. Now they want to not be held accountable.  It’s such a complex issue, I’d be surprised if you go to a town an hour away and ask people about preemption, they wouldn’t know. When you put it in a simple sentence people say, Oh My God, this affects me."

IB: Why do people not know? What do you tell them?  

Levine: “What I try to say is a drug company was really looking to shield themselves from being sued because of frivolous lawsuits they see written about in the paper and people fear. They’re losing sight that lawsuits are the only way to protect ourselves. You can’t rely on the FDA. The FDA is great, they’re doing their best, but they are limited.

“Federal preemption is a device drug makers have come up with to hide behind the apron strings of the FDA and shield themselves from being sued. Instead of using money to help the situation, they buy more advertising.”

IB:  Your Supreme Court case is about the FDA approved labels, do you believe they were inadequate?

Levine: “Yes, of course, all the label had to say was under no circumstances should the drug be administered with an IV push.”

***

Editors Note * - The question presented before the SCOTUS in the Wyeth brief is this:  Whether prescription drug labels imposed on the manufacturer by the FDA, preempt a state liability lawsuit based on the argument that a different label would have made the drug safer for use.

The FDA determined that Phenergan is safe and effective to use to treat nausea. It approved a label that said it could be administered in an IV injection. The FDA knew that exposure of arterial blood to Phenergan can result in severe injury including gangrene and that IV injection – including IV push injection – can lead to inadvertent arterial exposure if performed incorrectly.

The FDA did not direct Wyeth to contraindicate – i.e., eliminate it as a permissible method of administration – IV push or any other forms of IV injection.

A Vermont jury found Wyeth liable for failing to change the drug’s labeling to eliminate the IV push injection from approved ways to administer the drug.  Wyeth says to do so would be in violation of the Food Drug and Cosmetic Act under the FDA.   #


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