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3 November 2008

Justices Appear Torn Over Drug Labeling Case
Legal Times

Legal Times November 3, 2008
The Supreme Court appeared torn Monday over whether a federal law on drug labeling should pre-empt a jury’s $7 million verdict against Wyeth in the case of a Vermont woman who lost her arm to gangrene after being given a Wyeth drug for a migraine headache.

The case, Wyeth v. Levine, has been billed as a major milestone in the effort by the pharmaceutical and other industries to free themselves of unpredictable state court tort litigation by embracing instead a single federal regulatory regime—in short, federal pre-emption.

But based on the hourlong argument Monday, the case could be decided narrowly, giving little guidance about broader pre-emption issues beyond the area of drug labeling.

In 2000, Vermont guitarist Diana Levine went to a clinic seeking relief for her migraine. She was injected with the Wyeth drug Phenergan by means of one intravenous method that was discouraged but not forbidden by the labeling, which had been approved by the Food and Drug Administration.

The drug went into an artery rather than a vein, resulting in gangrene and amputation of Levine’s right forearm—effectively ending her musical career. She settled a lawsuit with the clinic and its personnel for $700,000, but pursued separate litigation against Wyeth in state court, arguing that its failure to prohibit the “IV-push” injection method amounted to a failure to warn and a product defect. A jury agreed, and the Vermont Supreme Court upheld the verdict, rejecting Wyeth’s pre-emption argument.

Appearing for Wyeth, former Solicitor General Seth Waxman told the justices that the FDA took into account the possibility of gangrene as a result of that kind of injection, but balanced it with the benefits of the drug.

That produced a sharp response from Justice Samuel Alito Jr., who asked, “How could the FDA conclude that IV-push was safe and effective” when the benefit was relief of nausea while the risk was gangrene? Justice Ruth Bader Ginsburg also asked incredulously, “No matter what benefit there was, how could the benefit outweigh that substantial risk?”

Waxman, a partner at Wilmer Cutler Pickering Hale and Dorr, answered that the label provided “ample, lavish warning” about the IV method, but the FDA determined that the method could be medically warranted in some circumstances—the kind of considered judgment that a jury, looking at a single case, would not make.

Justice David Souter also took Wyeth to task for not, on its own, going back to the FDA to urge changes in the label to prohibit IV-push administration: “Wyeth could have done that at any time, and it simply didn’t do it.”

Waxman pointed out that Wyeth in fact did ask for stronger language, but the FDA rejected it.

David Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel, representing Levine, picked up on Souter’s point and said the law would have allowed Wyeth to make a unilateral change in its label. The FDA, he said, never weighed the comparative risks of different types of IV administration of Phenergan.

“The idea that a label is set in stone for all time misunderstands the way the process works,” argued Frederick. “No reasonable person could have made this balance.”

“If you’re telling me the FDA acted irresponsibly, then sue the FDA,” said Justice Antonin Scalia. Scalia and several other justices seemed to have been persuaded that Wyeth had acted responsibly in informing the FDA about the risks and should not be punished for doing what the agency ordered it to do.

“You’re saying FDA approval doesn’t give you any protection at all?” asked Scalia. Frederick responded that it gives a company “a basis for marketing” a product but does not end the company’s duty to reveal problems that arise with that product.

Mayer Brown partner Andrew Tauber, who was at the Court for the oral argument, predicts a narrow ruling that will grant federal pre-emption in cases like Wyeth’s “where there are no allegations that the company withheld information” about potential risks and where the FDA rejected a stronger warning label.

“They may leave for another day what happens when this kind of information is not presented to the FDA,” says Tauber, who authored a brief in the case for the Product Liability Advisory Council in support of Wyeth.

Reprinted with permission from the November 3, 2008 edition of Legal Times © 2008 ALM Properties, Inc. All rights reserved. Further duplication without permission is prohibited.

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