Tuesday, November 04, 2008

Preemption Before U.S. Supreme Court

A good piece on the WSJ Law Blog regarding the Levine v. Wyeth case, which is front and center on the preemption issue.

Preemption simply stated is the position that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

In part from the WSJ Blog:

"At the center of the case is the delivery technique for an antihistamine called Phenergan. Diana Levine, the plaintiff, sought treatment for nausea. Clinicians administered Phenergan using a delivery technique called “IV push,” as opposed to “IV drip.” As a result, Levine, a guitar player, developed gangrene in her arm, which eventually required its amputation. Both Wyeth and the FDA were aware that the “IV push” risked inadvertent arterial injection and gangrene, but the FDA nevertheless approved labeling for Phenergan that warned against – but did not prohibit – IV push administration. (For more background, go to Scotus blog.) Superior court in Vermont had instructed a jury that the label’s compliance with FDA regulations did not establish its adequacy when considering Wyeth’s negligance. The jury awarded Levine more than $6 million in damages. "

Go here for more.

From various sources, it looks like the justices took issue with Wyeth’s argument that it couldn’t update its label to add stronger warnings without first getting FDA approval. “Wyeth could have gone back to the FDA anytime” to update the label, Justice David Souter said. “And it simply didn’t do it.” Source.

You can also read the transcript of the argument here.