CPR'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.
The question before the Supreme Court deals with an abstract legal rule called the pre-emption doctrine. The Constitution says that a state law that conflicts with federal law is null and void. Wyeth argues that because its label was approved by the U.S. Food and Drug Administration, Vermont's more protective common law is pre-empted....
If regulatory agencies were perfect, common law liability might be unnecessary. But by all accounts, FDA and other federal agencies are starved for resources and often more concerned with meeting industry demands for expeditious approvals than with protecting the public.
Of course, pharmaceutical litigation is hardly the only area in which pre-emption would shield manufacturers from liability for dangerously defective products. A broad victory for Wyeth will make it harder to hold manufacturers of other products to account, too, including manufacturers of defective toys, poorly designed automobiles and flammable clothing.
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.