Levine successfully argued that, even though Phenergan labeling complied with FDA requirements, the adequacy of the warning still wasn’t established. This referred to a particular method for administering Phenergan known as IV push. Moreover, Levine’s attorneys contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine was awarded more than $6 million and, despite appeals, the Vermont Supreme Court sided with her. But Wyeth has appealed again and now the US Supreme Court agreed to review the case.
Why? At issue is preemption - a legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency's actions are the final word on safety and effectiveness. The court's decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. We chatted with Levine, 62, about her plight and the legal battle. This is an excerpt...
Pharmalot: Before this episode, you were a professional musician. What did you do? Levine: Back in 1989, my husband and I started a label, called Rebop Records, which I did to combine my passion for music and songwriting, and my love for kids. I played bass, guitar and piano. Sometimes, I'd play with my sister, who lives nearby, or my husband in local bands. The label was designed to provide rock and roll that kids and parents could enjoy together.
Pharmalot: But in 2000, you went to the hospital and Phenergan was administered. What happened? Levine: I have a history of these migraines and, normally, I can manage them, but on occasion, they could be excruciating and debilitating, and I'd get hauled off to the emergency room. Normally, I'd get Demerol for the pain and then Phenergan, because the Demerol would make me nauseous. And it would be intramuscular administration, which was normally a shot in the butt. This time, they gave me a push IV and that's what caused the problem When I woke up, I was still in pain.
Pharmalot: At what point was your arm in jeopardy? Levine: This went on for two or three weeks. It's a bit of blur now. But I was taking bloodthinners and morphine and painkillers. The doctors tried desperately to keep my hand. I'd never been in such pain. There were two procedures, though. The first was to amputate the hand. But it became obvious that the skin (below the elbow) wasn't going to regenerate and get healthy. The gangrene was still there. So I told them to take as little (of the arm) as you have to. The trauma seemed insurmountable. The best I could say was that I hadn't died.
Pharmalot: What did this do to your life, and your music? Levine: Well, it stripped me of my career and my business and my ability to do what mattered most. I had to start from scratch. I'm left-handed and it was my right arm that was affected, so in a way, it was a blessing. Although I tried to do too much and developed over-use syndrome. Anyway, I was eventually outfitted with a prosthesis. And now I can hold a guitar pick and strum and make a chord. I still work with kids, but I can't tell you how many times they ask what happened. I tell them one is my soft hand and the other is my hard hand.
Pharmalot: What's your view of Wyeth and its actions? Levine: They should've taken responsibility for changing the label...
...It's not a bad drug. It's a good drug, for what it is. But I'd much rather throw up than lose my arm. I think they should've come out and said that, under no circumstances should the drug be administered under push IV. They didn't protect me and ensure my safety...They have strong economic incentives and, sometimes, those things take precedent...They say the FDA is their first line of defense, but if a drug company recognizes there's something that could hurt the public, they have an obligation to do something.
Pharmalot: What do you think about the Supreme Court agreeing to review your case? Levine: Well, those nine judges aren't supposed to be influenced by whatever goes on between industry and the administration (which back preemption). I just have to have faith...If people like me are denied the ability to sue a drug company, well, a drug company has a mind of its own. They know when something is dangerous and they can change it. Think of all the little clinics and emergency rooms that may know as a result of my case. But it's Wyeth's responsiblity to let them know, not mine.
I can understand why (Wyeth) is doing this. It's probably because of all the frivolous case. But don't punish me or change a sytem that, right now, helps keep people safe. The only way I look at it is that now I have an opportunity to talk to people. Millions are now paying attention to the situation. I'm up on my soapbox and I'm going to create awareness. Hopefully, that'll lead to change. It's a shame we have to take this upon ourselves. Why should I have to be the savior? It's astonishing to me that the Supreme Court took this, but I'm going to make the best of it.