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Tom McGarity on preemption in November 28 Austin American Statesmanby Matt FreemanCPR's Tom McGarity has an op-ed this morning in the Austin American Statesman on Wyeth vs. Levine, the Supreme Court case testing an assertion by pharmaceutical manufacturer Wyeth that FDA approval of its proposed drug label shields the company from tort litigation over harm that drug subsequently causes. The Court heard oral arguments on the case on November 3, and a ruling is expected later this term.
The case arose out of one of those medical disaster stories we all fear. Diana Levine went to visit a doctor, complaining of a migraine. Her treatment included an injection of Wyeth's anti-nausea drug, phenergan. The label on the drug carries a caution about the so-called IV-push method of injection -- a shot. The better method is an IV-drip -- where a bottle is hung and the drug introduced more slowly into the vein. The danger is that the drug will get into an artery, a complication that is apparently taken off the table with an IV-drip, but possible, if uncommon with IV-push. Levine received phenergan via IV-push, things went wrong, the drug reached her artery, and tissue began to die. Before the saga was over, her arm was amputated, and her career as a professional guitarist effectively over.
She sued Wyeth, and in court, the company argued that because their label merely cautioning, not instructing, against IV-push was approved by the FDA, that they're not liable.
McGarity writes:
The full op-ed is in this morning's Austin American Statesman. McGarity's new book on preemption comes out December 2: The Preemption War: When Federal Bureaucracies Trump Local Juries. (Amazon and others have the book in stock already.) There's an interesting Q/A with Professor McGarity on the University of Texas website, here.
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