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Drugmaker loses labeling case

Posted On: Mar. 8, 2009 12:00 AM CST

WASHINGTON--The U.S. Supreme Court's ruling circumscribing the theory of implied pre-emption of state law by federal rules concerning prescription drugs could reach beyond the pharmaceutical industry, according to legal experts.

The case--Wyeth vs. Diana Levine--centered around a warning label on the antinausea drug Phenergan. The label, which was approved by the U.S. Food and Drug Administration, cautioned physicians only about injecting the drug with the so-called "IV-push" method, but did not forbid it. In that method, a drug is injected directly into a patient's vein.

When musician Diana Levine received the drug via the IV-push method, the injection nicked an artery on her right arm. She developed gangrene and much of her arm was amputated. She sued the drug's maker, Madison, N.J.-based Wyeth.

A Vermont jury held that the injury would not have happened if the label included an adequate warning. The Vermont Supreme Court agreed in 2006, and upheld the nearly $6.8 million product liability verdict against Wyeth. The drugmaker "could have warned against IV-push without prior FDA approval," the court's majority held.

Wyeth appealed to the U.S. Supreme Court, holding that the FDA's approval of the warning pre-empted any state action.

A majority of the U.S. Supreme Court disagreed and ruled 6-3 last week in Ms. Levine's favor. The court "cannot credit Wyeth's contention that the FDA would have prevented it from adding a stronger warning," wrote Associate Justice John Paul Stevens. "Wyeth has failed to demonstrate that it would be impossible for it to comply with both federal and state requirements."

The court also rejected Wyeth's contention that a preamble to a 2006 FDA regulation governing the content and format of prescription drug labels, which said state law "frustrated" the FDA's implementation of its statutory mandate. But the statement did not amount to a pre-emption, according to the court. The court said that when Congress does not directly authorize a federal agency to pre-empt state law, the court has to examine the agency's explanation of a state law's impact based on the thoroughness, consistency and persuasiveness of that explanation. The court said the 2006 preamble didn't meet that standard.

In a concurring opinion, Associate Justice Clarence Thomas questioned whether implied, rather than express, pre-emption could exist.

The decision certainly reins in implied pre-emption, product liability experts say. "It does put down a real roadblock on implied pre-emption," said Victor Schwartz, a partner with Shook, Hardy & Bacon L.L.P. in Washington. "It does not mean the death knell for all agency pre-emption, but the agency will have to have engaged in clear reasoning and authority for taking a position that its regulations are pre-emptive," said Mr. Schwartz, who also is general counsel of the American Tort Reform Assn.

A defense attorney specializing in prescription drug cases agreed.

"It's quite significant, but I wouldn't call it sweeping," said James M. Beck, counsel with Dechert L.L.P. in Philadelphia. "It all comes down to what the facts are going to be. If the facts show that there is actually significant affirmative FDA action having to do with the particular risk, then there's a shot at pre-emption; if there's not and as the court certainly interpreted Levine, there's not going to be pre-emption."

He said the ruling could reach beyond pharmaceuticals. "Where it might come in is with other products under similar schemes," Mr. Beck said. He added that the decision might cool congressional ardor to scale back pre-emption.

Sol Weiss, a plaintiffs' attorney and shareholder with Anapol Schwartz P.C. in Philadelphia, called the decision "remarkable."

"You got a 6-3 decision. You have Justice Thomas basically saying 'I don't think you can have implied pre-emption' and you've got Justice Stevens and the majority saying that there is again a presumption against implied pre-emption.

"I think this has the opportunity to be a very widely understood opinion that basically refocuses all pre-emption on congressional intent," Mr. Weiss said. "That's very big."

Wyeth vs. Diana Levine; U.S. Supreme Court. No. 06-1249; March 3, 2009.