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High Court Hears Arguments on Limiting Drug Company Lawsuits

November 3, 2008 at 12:00 AM EDT
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The Supreme Court heard a case Monday involving a Vermont woman whose arm had to be amputated after she was injected with an anti-nausea drug. Marcia Coyle examines the manufacturer's argument against lawsuits on FDA-approved drugs.
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JIM LEHRER: Now, that Supreme Court argument about limiting lawsuits against drug companies. Margaret Warner has our story.

MARGARET WARNER: The case involves Diana Levine, a Vermont woman whose arm had to be amputated after she was injected with an anti-nausea drug. She successfully sued the drug’s manufacturer, Wyeth Pharmaceuticals, in state court.

The company contends her suit is pre-empted by federal law because the drug and its label were FDA-approved.

Today the high court heard arguments from both sides. And here to walk us through the case is NewsHour regular Marcia Coyle of the National Law Journal.

Marcia, hello.

MARCIA COYLE, National Law Journal: Hi, Margaret.

MARGARET WARNER: Now, this is a particularly painful tale, given Diana Levine’s profession. What happened?

MARCIA COYLE, National Law Journal: Diana Levine is — was a bass guitarist and a composer of children’s music. She went to a clinic for medicine to assist her in migraine-related nausea.

The drug that was used and has been used since about 1955 was Phenergan. And it was administered through injection into an IV line that was supposedly going into a vein in her arm.

But unfortunately, and tragically, it went into an artery. And when that happens, when it mixes with arterial blood, the result is gangrene. She lost first her hand and then later her forearm.

MARGARET WARNER: And a jury in Vermont gave her a big judgment against Wyeth.

MARCIA COYLE: They did. The jury found that Wyeth should have had more adequate warning on the label for the drug and awarded her a little over $6 million in damages.

The Vermont Supreme Court agreed with the jury. And Wyeth today is taking Levine to the Supreme Court in which we heard the arguments.

Drug company defends labeling

MARGARET WARNER: All right. So what was the Wyeth lawyer contending today in saying this wasn't Wyeth's responsibility?

MARCIA COYLE: Wyeth said it really can't serve two masters here. It can't serve the Food and Drug Administration, which requires it to put certain information on its labels, and explicit information on its labels, and it can't serve a state court jury, which says it should have used a different kind of label.

That creates a conflict. And when there's a conflict like that, federal law pre-empts the state personal injury suit.

MARGARET WARNER: Now, what -- and we're talking really about these inserts that we get when we have -- when we get a prescription drug, those many pages, the little print and thin paper. What did the warning say?

MARCIA COYLE: The warnings in several sections in the labeling package laid out risks associated with intravenous use of Phenergan. And there is a conflict here between the lawyers in the case over whether the labeling and the FDA, in particular, really addressed the risk associated with I.V. Push, which is putting the syringe into the I.V. line that goes into the vein.

MARGARET WARNER: So, now the lawyers for Diana Levine, what was their argument that, in fact, despite the fact this was an FDA-approved insert, that the company had to do more?

MARCIA COYLE: Levine's lawyer, David Frederick, said there is no conflict here between what Wyeth has to do with federal law and what it has to do under state duty of care, because there is a provision in the federal law that allows the drug manufacturer to come forward at any time when there's information of a particular risk and strengthen the warning label.

Mr. Frederick contends Wyeth knew about the risk associated with the drug and gangrene, at least in the 1970s, through the '80s and '90s, and should have come forward and strengthened the warnings on the label or have provided information that would have banned the use of I.V. Push with this drug.

Justices question FDA decision

MARGARET WARNER: How did the justices respond?

MARCIA COYLE: Well, with Wyeth, the justices first were somewhat skeptical of a conflict here. And Justice Ginsburg, you know, raised the issue, well, you know, the warning labels talk about intravenous injection, but they really don't mention I.V. Push. So, really, was this an adequate warning?

And Mr. Seth Waxman, who represents Wyeth, argued that there were ample warnings in the labeling package.

Justice Alito had a very basic question. He said, how could the FDA find this drug was safe if the risk was gangrene? And Justice Ginsburg also picked that up, saying that clearly, you know, could the benefit outweigh the risk when such a dramatic risk was at issue here?

And Mr. Waxman, again, he said that the labeling contained ample warnings. It gave a hierarchy of uses by physicians. And you don't always want to take away one particular option like the I.V. Push.

MARGARET WARNER: Now, what's at issue here is this doctrine of pre-emption. Explain that.

MARCIA COYLE: It's basically a doctrine that bars injured consumers from going into state courts because there's a federal law that controls the area that the consumer is suing under.

A far-reaching ruling

MARGARET WARNER: So potentially how wide are the ramifications of a ruling in this case?

MARCIA COYLE: This has really wide ramifications. First of all, this particular law, in terms of drug regulation, doesn't have an option for consumers to go into federal court. So if the suit is pre-empted, injured consumers are basically out of luck.

Secondly, whatever the court says about this kind of pre-emption, implied pre-emption in a law, well, it could very well impact consumers who are suing for injuries from motor vehicles, from chemicals, pesticides, even household products.

MARGARET WARNER: So much, much broader than just FDA-approved products?

MARCIA COYLE: Absolutely. And, of course, it's extremely significant to Diana Levine.

MARGARET WARNER: Absolutely. Well, Marcia, thank you.

MARCIA COYLE: You're welcome. My pleasure.