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U.S. Supreme Court: Drug makers not protected by warning labels.

Michelle Franzen / NBC News
March 4, 2009 - 7:53pm
UNDATED - In a blow to pharmaceutical companies, the U.S. Supreme Court ruled Wednesday that drug makers can be held liable for harm from medicines labeled with warnings approved by the Food and Drug Administration.
In a vote of six to three, Supreme Court Justices upheld Vermont's Supreme Court ruling rejecting Wyeth's argument that FDA approved labeling pre-empts state law liability claims.
The case involved Diana Levine, a popular Vermont guitarist.
Levine sought treatment nearly nine years ago for a migraine headache.
She was given the drug, phenergen, injected through an I-V tube.
When the medicine came into contact with an artery, it damaged part of her arm and doctors had to amputate.
"I woke up and it was this long. And it was horrible, it was just traumatic," said Levine.
A Vermont court ruled the drug maker didn't go far enough with the warning labels about the dangers of administering the drug through an I-V and awarded Levine more than six million dollars.
Levine said Wednesday she feels vindicated.
"This is an unbelievable day. I feel a huge weight lifted off of me. I'm just so relieved that the justices came back with that 6-3 decision and it really restores my hope in the justice system."
Law professors following the case, say the ruling is also a blow to the Bush Administration, who supported federal pre-emption and the impact goes beyond the FDA.
"For the last 8 years the federal government has claim every time it regulates a product it pre-empts state law," said Georgetown Law Professor David Vladeck.
It's a marquee case for states and consumers, and the end of a long legal battle for Levine.






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