12:00 AM
 | 
Sep 22, 2008
 |  BioCentury  |  Regulation

Showdown on preemption

With 29 "friend of the court" briefs in hand at its August deadline, the U.S. Supreme Court is set to hear oral arguments on Nov. 3 in this year's third and most anticipated case pitting FDA's assertion of preemption authority against state tort laws when a patient has allegedly been harmed by an FDA-approved product. The outcome of Wyeth v. Levine will likely hinge on how the justices interpret the fuzzy area of "implied preemption."

FDA believes that drug labeling cannot be amended without the agency's approval unless a manufacturer has new data showing a causal link between the drug and a safety hazard. FDA also believes that allowing manufacturers to change label warnings would disrupt the agency's congressional mandate to balance how the risks and benefits of drugs should be communicated.

Diana Levine's counsel and her supporters, including some Democratic legislators, argue that Congress has reserved states' rights to require safety warnings that are stronger than an FDA-approved label.

"The court will be tasked with analyzing and characterizing the conflict - if it exists. If it does, then is that conflict sufficient to invoke preemption?" said Arun Thomas, a litigation attorney for Eckert Seamans Cherin & Mellott LLC in Washington.

A broad win for Wyeth would knock out the most common avenue for tort suits and the easiest for plaintiffs to win: failure to warn. Alternatively, a Wyeth loss would widen an already open door for a multitude of tort suits against drug manufacturers.

"There are lots of lawyers lined up and ready to sue," said John Calfee, a resident scholar with the American Enterprise Institute who filed an amicus curie brief in support of Wyeth.

The two less common types of preemption lawsuits, negligent manufacturing and negligent design, would not be affected by this action.

Wyeth v. Levine

The current case hinges on whether Wyeth failed to properly warn of the dangers of intra-arterial administration of Phenergan promethazine to treat nausea associated with migraine. Levine's forearm was amputated following an IV push injection of Phenergan.

Phenergan is approved for administration via deep intramuscular injection or IV. IV administration produces clinical effects four times faster than intramuscular administration and is therefore beneficial for patients in need of rapid treatment.

However, IV administration also increases the risk of arterial exposure that can result in gangrene. But because of the benefit of more potent and expeditious nausea relief, FDA did not ask for a label contraindicating IV administration or IV push.

Phenergan has been on the market since 1955, and FDA has reviewed the drug's labeling with respect to arterial blood exposure repeatedly since at least 1967, according to Wyeth.

At the time Levine was treated, Phenergan's label warned that inadvertent intra-arterial administration of the drug could cause gangrene resulting in amputation.

"FDA approved labeling that maintained IV injection as an approved method of administration and...

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