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High Court Case Looms Large for Drugmakers
By the mid-1960s, according to court documents and company officials, Wyeth had learned of a dangerous side effect when the drug is administered directly into a vein, a method known as IV-push. If the Phenergan mixes with blood from an artery, it can cause irreversible gangrene.
Wyeth alerted the FDA, which imposed a series of warning labels. At the time Levine was treated, the label instructed doctors to be extremely careful when using IV-push and specified gangrene as a side effect. Court documents said about 20 patients -- out of more than 200 million -- have been stricken with gangrene. The company and FDA think that risk is minimal enough to justify keeping IV-push as an option because it gets the drug into the bloodstream immediately.
After Levine received the drug intravenously, her headache was gone but her right arm hurt. Thus began a weeks-long ordeal to save the arm, which "turned all kinds of colors, purple, green, blue and black," she said.
The gangrene proved unstoppable. "The thought of losing my arm was horrible, but it was a life-or-death situation," said Levine, who woke up from the amputation in utter despair but has "since become grateful that I have an elbow. There are a lot of things you can do with an elbow."
Levine, who owns an independent record label, today uses several prosthetic arms and says her business has been "crippled." She sued Wyeth under a Vermont product liability law, and her attorneys yesterday argued that Wyeth should have warned doctors to not use IV-push because of the risk.
Wyeth maintained that its warning label was specified by the FDA, the sole regulator of the drug industry, and that the judgments of state laws and juries cannot be substituted for FDA expertise.
A Vermont jury disagreed, awarding Levine the $7.4 million, which was reduced to $6.7 million by a judge.
Levine, who attended yesterday's argument, said the experience has devastated "my whole self-image, my musical identity and my livelihood."
"The company took my arm. They need to take responsibility for that," she said.