(Host) A Vermont woman is at the center of a U.S. Supreme Court case that could determine the rights of consumers to sue over dangerous products.
The woman is Diana Levine, a musician who lost her right arm because of a medical disaster.
VPR’s John Dillon has the story that leads from the back roads of Marshfield to the marble halls of the Supreme Court.
(Dillon) Eight years ago, Diana Levine went to get treatment for a migraine headache and ended up a few weeks later having her arm amputated.
A local health clinic gave her a shot for the nausea associated with the crushing migraine. But the drug that was used – it’s called Phenergan and it’s made by Wyeth pharmaceuticals – causes irreversible damage if it’s exposed to arterial blood.
That’s what happened to Levine.
(Levine) “If it comes in contact with any trace of arterial blood, that’s it. It just goes right into your blood stream, goes right down into your little capillaries and then it clots like crazy.”
(Dillon) Her wrist and hand turned black as the tissue died. Gangrene set in. Doctors tried to stop the spread of dying tissue, but there was nothing they could do.
(Levine) “It was a shock when I was told that I was going to have an amputation.”
(Dillon) Levine tells the story as she sits at a picnic table on a sunny fall day in Marshfield. She says she eventually went through another operation, and spent months in the hospital recovering. Her right arm now ends right below the elbow.
(Levine) “He tried to save my wrist with the first amputation… I was still in horrible pain, and we watched it creep up, the black and the tissue decay and they were making dotted lines on my arm, and, he came in and said, `It can’t be done, I’ve got to do it again.’ I said, `okay.”’
(Dillon) Levine says she didn’t have to lose her arm. She says Wyeth’s own records show that the company knew – but failed to adequately warn about – the serious risk from the way the drug was given to her.
(Levine) “To be given something just for nausea and then find out later that they knew that this could happen.”
(Dillon) Diana Levine’s medical calamity is now the top business case before the U.S. Supreme Court.
The legal odyssey started with a lawsuit filed in a Vermont court. A Washington County jury came back with a $6 million judgment against Wyeth. The company appealed, and the Vermont Supreme Court upheld the jury verdict.
Wyeth then went to the U.S. Supreme Court, which agreed to hear the case next month.
Wyeth officials were not available for this story. The company supplied a statement from its lawyer, Bert Rein, who argued the case in Vermont. Rein said – quote:
"The Vermont decision puts the company between a rock and a hard place. Does it adhere to federal law, or follow state law and risk an investigation by the FDA for a possible commission of a felony — the mislabeling of an FDA-approved drug and label?"
(Dillon) The legal doctrine that Wyeth wants the high court to impose is called pre-emption. Business groups and the Bush Administration argue that if a product is approved by the federal government, consumers should be barred from going to state court for relief.
But many independent voices disagree.
(Curfman) “You know, FDA review is very good, but it’s never absolute.”
(Dillon) Dr. Gregory Curfman is a physician and executive editor of the New England Journal of Medicine. He says patient safety relies on two systems: FDA review, and state court actions. He says if Wyeth wins on pre-emption, the result will be drugs that are less safe.
(Curfman) “Our concern is that if the possibility of product liability suits is essentially pre-empted and that drug companies are immunized against these kinds of product liability suits, that one whole layer of regulation that has been there forever will be gone and we’ll be left with only a single layer of regulation.”
(Dillon) Cheryl Hanna, who teaches constitutional law at Vermont Law School, says the Levine case is one of the most important to be heard by the high court in 10 years.
(Hanna) “All those people who are injured in some way by a drug or other medical device, they can’t go to state court and sue claiming that the pharmaceutical injury was negligent by failing to warn them of the dangers and by putting a defective product on the market. They’re essentially going to be foreclosed from that.”
(Dillon) Diana Levine says she wants to win, and not just because she was permanently disfigured, lost much of her livelihood, and needs the money for medical care.
(Levine) "I mean, they can’t give me my arm back, obviously. But they changed my life inalterably and it didn’t have to happen because they knew about all the cases ahead of me that it had happened to. And beyond that, they should change the label so it doesn’t happen to anyone else.”
(Dillon) The Supreme Court will hear the case on November 3.
For VPR News, I’m John Dillon in Montpelier.