What if you went to a doctor for a migraine and ended up with gangrene so bad in your arm that it had to be amputated? That’s what happened to Diana Levine, a Vermont guitarist with headaches. Injected with the Wyeth drug Phenergan by means of one intravenous method that was “discouraged but not forbidden” by the FDA (Food and Drug Administration), the drug went into an artery instead of a vein.
The result was gangrene and the loss of her right forearm, which has ended the guitarist’s career. On Monday, the Supreme Court “appeared torn over whether a federal law on drug labeling should pre-empt a jury’s $7 million verdict against Wyeth…,” reported The National Law Journal. “The case, Wyeth v. Levine, has been billed as a major milestone in the effort by the pharmaceutical and other industries to free themselves of unpredictable state court tort litigation by embracing instead a single federal regulatory regime — in short, federal pre-emption.”
Solicitor General Seth Waxman told justices that the FDA took into account the possibility of gangrene? Wait, what? They went on to say that after balancing it with the benefits of the drug, they let it pass their inspection.
Justice Samuel Alito Jr. responded, “How could the FDA conclude that IV-push was safe and effective when the benefit was relief of nausea while the risk was gangrene?”
“No matter what benefit there was, ” added Justice Ruth Bader Ginsburg, “how could the benefit outweigh that substantial risk?”
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