A Vermont musician who lost her arm after a botched drug injection says the U.S. Supreme Court’s decision to uphold a $6.7 million verdict against the pharmaceutical company that made the drug is a victory for consumers.
“I just feel really good for what this means for the whole country,” said Diana Levine, 63. “The money, to me, means the company was held accountable for something that didn’t need to happen, number one.
“So hopefully, they’ll learn their lesson from it and change the label so this doesn’t happen to any more people,” she said.
Rejecting calls for limits on lawsuits against drug companies, the high court last Wednesday upheld the award against Wyeth Pharmaceuticals, the maker of anti-nausea drug Phenergan. In a 6-3 ruling, the court turned away Wyeth’s claim that U.S. Food and Drug Administration approval of the drug and its warning label should have shielded the company from Levine’s suit.
Levine’s nightmare began in 2000.
Suffering from a migraine headache, she went to a local clinic and was given painkillers and received an intramuscular injection of Phenergan. When she still felt nauseated, she was given an “IV-push” of the drug, with the second injection accidentally puncturing an artery. Gangrene set in. Several weeks later, her right arm was amputated.
“It basically took away my whole musical identity. I’d been playing music for 30 years, working with kids, writing songs. I played guitar, piano, bass in a rock band. I couldn’t do any of those things anymore,” she said.
She lost more than her music and her livelihood.
Suddenly, what was routine became a challenge. The drawers in her 150-year-old farmhouse needed two hands to be opened. A left-hander, she still had one hand to use, but she relied on it to compensate so much that she injured it with overuse.
She couldn’t shovel or scrape ice off the windshield of her car, a real hardship in rural Vermont. In summer, she can’t open a window without help.
“Nobody, nobody understands what it’s like to just operate with one hand. Everything you do requires two hands, even when you think you only need one,” she said.
For years, Levine wondered whether Wyeth would ever be held accountable.
Last Wednesday, it was.
In the majority opinion, Justice John Paul Stevens said Wyeth could “unilaterally strengthen its warning,” especially after it learned of at least 20 cases before Levine’s injury in which an injection led to gangrene and amputation.
Levine, who had previously settled a lawsuit against the clinic, broke down in tears when a reporter called her with news of the decision.
“My knees were buckling, and I was crying,” she said. “The people that were here thought something horrible had happened. Until I said, ‘I’m so happy.’ Then, they knew.”
These days, she gets physical therapy for her remaining hand and welcomes the big-money award both for the vindication it represents and the practical obstacles it can help eliminate. For one thing, she’ll build a garage.
And she’ll buy a new prosthetic. She might even get her car adapted so she doesn’t have to use her left hand to reach across the steering column to reach the ignition.
“It’s very good for her spirit,” said daughter Jassamine Levine, 26. “Both of our spirits were wibbling and wobbling, like ‘How can this be possible, that a company could value money and power over what’s right?’ It’s pretty unfathomable.
“But the fact that the justice system worked, it’s pretty impressive,” said the daughter.
Wyeth is in the process of being bought by rival Pfizer Inc. in a $68 billion deal that is expected to close later this year.
Wyeth said it was disappointed by the ruling.
“When lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs,” the Madison, N.J.-based company said in a statement.
Drug industry analysts say the ruling will force makers to scrutinize safety issues of all experimental drugs in development, as well as existing products.
“They will weigh how prevalent the side effect is, how serious the side effect is, versus the number of people benefiting from the drug and the amount of money being made by the drug,” said Erik Gordon, an analyst and professor at University of Michigan’s Ross School of Business.
“This is like blood in the water for plaintiff lawyer sharks,” and will encourage more lawsuits, Gordon added.
Levine says she would happily trade the money for her arm, if she could.
“I miss my arm. I really miss my arm. I grieve the loss of my arm, nine years later. I would give $6 million for my right arm,” she said.
Associated Press writers Mark Sherman in Washington and Linda Johnson in Trenton, N.J., contributed to this report.
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