Supreme Court Hears Arguments on Drug Labeling in Case of Woman Who Lost Forearm to Gangrene

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Published November 04, 2008

| FoxNews.com

Diana Levine was all smiles outside the Supreme Court Monday morning after watching oral arguments in a case that bears her name. Whether she will still be smiling when the justices release their opinion is another matter.

The Court heard spirited arguments over the responsibilities drug manufacturers have for the labels placed on their products. Levine's lawyers said the manufacturers bear ultimate responsibility, while the lawyer representing the drug company at the center of this case said the Food and Drug Administration's oversight of labeling is necessary for marketplace cohesion.

Today's arguments mark the second time this term and third time in a year the Court has heard arguments about "preemption." This is the principle that a federal agency — in this case, the FDA — preempts most related state laws with its own rules and oversight. The premise behind this idea is to provide the marketplace with a single uniform standard of regulation.

The hour-long arguments started with Wyeth Pharmaceuticals lawyer Seth Waxman telling the Court that the FDA approved the drug Phenergan with a label showing a "cascading hierarchy of injection methods" — the very last of which is the "IV push" method, which was used on Levine.

In April 2000, Levine went to her local health center for treatment related to a severe migraine headache and nausea. A physician assistant at the health center gave her Phenergan and administered it intravenously. Unfortunately, the syringe injected into Levine's arm apparently missed the vein, and within a couple of weeks the forearm turned gangrenous and had to be amputated.

After reaching settlements with the health center and its workers, Levine filed suit against Wyeth in Vermont state court. She claimed the label did not sufficiently address the risks associated with taking Phenergan intravenously.

A jury found in Levine's favor and awarded her $7.4 million. The Vermont Supreme Court upheld the jury's decision, concluding that there was no conflict between the interests of the federal and state governments. It wrote that the "FDA and the state share the purpose of encouraging pharmaceutical companies to alter their drug labels when they are inadequate to protect consumers."

Waxman led the charge for Wyeth against this idea of shared oversight with the states. He argued the FDA's role is to approve drugs and offer guidance to doctors, noting potential risks — something he says was adequately done in this case.

"All that information was available to physicians, and the FDA has to understand and does understand that in labeling to allow medical professionals to make their judgments, taking options away from physicians is not always better," he said. "It may not even often be better. What the FDA has to decide in terms of telling physicians what's on the table and what's off the table, and in terms of what's on the table what the relevant risks are is, is this ever — would this ever be medically warranted? The testimony in this case and in the administrative record was yes."

Levine's lawyer, David Frederick, argued Wyeth should have noted on its own the severe and known risks of the IV push method. "[H]ad Wyeth been a reasonably prudent manufacturer over the years, it would have known that the risks of IV push so far outweigh any bearing negligible benefits, that it would have offered a stronger instruction..."

Frederick said it was ultimately Wyeth's responsibility to make an instruction not approving of the IV Push method because of its several potential for error — as happened with his client. The question drew the interest of several justices, including Ruth Bader Ginsburg. "No matter what benefit there was [from the method], how could the benefit outweigh that substantial risk [of gangrene and amputation]?" Ginsburg asked.

Frederick contends the FDA never really weighed the benefits and costs of the method, thus making its approved label insufficient. Something Frederick says Wyeth knew was a serious issue and therefore should have on its own accord made clear on the label.

But Chief Justice John Roberts and Antonin Scalia hammered Frederick on this point, wondering at what point and for what level of risk are drug companies required to change labels from what the FDA proscribed.

"When [the FDA determines] that it's safe to use it under those circumstances, that necessarily includes a consideration of the risk. People can say it's safe for you to walk down the sidewalk. That doesn't mean there is no risk that you get hit by lightning or something else," said Roberts. "It just means in evaluating them together, they determine that it's worth the candle in particular cases where a physician determines that that's the indicated method."

In a similar preemption case decided in February, the Court sided 8-1 in favor of a medical device manufacturer. And on October 6, the justices, while not impressed with the FDA's oversight of tobacco, appeared to be leaning against Maine's claim that they could force changes on cigarette labels.

This didn't seem to matter to Levine Monday, who through her smiles said she was "speechless" about her case and happy to be inside the Court. She was also spotted holding a pair of ceremonial quills given to lawyers who argue cases before the Court. When asked if she was keeping them, she said "Oh yeah!"

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