JEFFREY BROWN: In a significant defeat for the pharmaceutical industry, the justices today said lawsuits brought against drug companies in state courts may go forward, even if the drug in question had received federal approval.
To explain the decision and its impact, we’re joined once again by Marcia Coyle of the National Law Journal.
MARCIA COYLE, National Law Journal: Thanks, Jeff.
JEFFREY BROWN: First, the facts of this case. It involves a kind of nightmare outcome of the use of a drug.
MARCIA COYLE: Very tragic facts. As part of her treatment for migraine headaches, Diana Levine took the drug Phenergan, which is an anti-nausea drug. The drug’s manufactured by Wyeth, and it can be delivered in two ways, through an I.V. drip, which is exactly what it sounds like, an I.V. bag and it drips into a catheter inserted in a vein, or through an I.V. push, which is a direct injection into a vein.
But if the drug mixes with arterial blood, gets into an artery, it caused irreversible gangrene, and that’s what happened to Diana Levine. They gave her the drug through an I.V. push, it caused gangrene, and doctors had to amputate first her hand and then her forearm. She also lost her career as a professional musician.
Case involved preemption doctrine
JEFFREY BROWN: So she sued Wyeth in state court and won $6.7 million. Her argument was that the label did not correctly...
MARCIA COYLE: It wasn't adequate.
JEFFREY BROWN: ... wasn't adequate for how it should be administered.
MARCIA COYLE: That's right. It warned that there could be gangrene if the drug went into the artery, but she claims that it didn't tell clinicians that they should use the I.V. drip instead of the higher-risk I.V. push. She won, as you said, the Vermont Supreme Court affirmed, and Wyeth was the party that brought the case to the Supreme Court.
JEFFREY BROWN: OK, so bring us up to date on this decision. It revolves around a doctrine called preemption.
MARCIA COYLE: Yes.
JEFFREY BROWN: Want to explain that first?
MARCIA COYLE: When Congress legislates in a certain area, when it regulates a certain area like drugs, and the state has also regulated in a similar area, if the state's regulations or requirements conflict with the federal ones, Congress will -- I'm sorry, if it conflicts with the federal regulations, then federal law prevails, and that's preemption. Preemption is basically saying, "We're going to block the state law and any actions under that state law."
JEFFREY BROWN: And in this case, it means the FDA approval of the label?
MARCIA COYLE: That was Wyeth's argument. It said that her lawsuit could not go forward because the labeling had to be and was approved by the FDA. And Wyeth also argued that it was impossible for it to comply with both the state and the federal requirements and, because there is a conflict, federal law prevails.
Drug labeling at case's core
JEFFREY BROWN: All right. So the court today ruled against Wyeth, 6-3. What was the reason?
MARCIA COYLE: A decision by Justice John Paul Stevens, and he rejected Wyeth's impossibility argument. He said, basically, although it's true that manufacturers, drug manufacturers, generally can't change a label after the FDA has approved a new submission, there was a regulation that the FDA allowed a change when it was required, based on new information, as long as the drug manufacturer followed up with supporting documents.
He said Wyeth could have strengthened its warning once it received notice, which it did have, that there were amputations occurring as a result of the use of -- how the drug was being used.
JEFFREY BROWN: Cases before the one that happened in Vermont?
MARCIA COYLE: That's correct. In fact, there were about 20, I believe.
JEFFREY BROWN: All right. And the dissent was by Justice Alito?
MARCIA COYLE: Justice Alito wrote a dissent that was joined by the chief justice and Justice Antonin Scalia.
Justice Alito said that this was an example of tragic facts making bad law. He said the FDA's 40-year-long history of regulating the safety and the efficacy of this particular drug really demanded the conclusion that the state court lawsuit was pre-empted by the federal law.
Many businesses favor pre-emption
JEFFREY BROWN: Now, the wider impact here. You were on the program when this was argued, because this was a big effort by the business community, as I remember, and the Bush administration to get these preemption provisions into law.
MARCIA COYLE: Absolutely. Business likes federal preemption because business wants to be regulated by one uniform law. It doesn't want to have to submit to 50 different laws in different areas of the law.
On the other hand, some state laws are more protective of consumers than some federal laws. And businesses, also, doesn't quite trust local juries.
The Bush administration aided businesses' effort by having federal regulators in a number of areas, like transportation and drugs, insert pre-emption language into federal regulations. They did it in the drug context in this case. Justice Stevens said that language was put in without any notice, without any public comment, and it deserved no deference.
Impact on other industries
JEFFREY BROWN: So looking out further now, what kind of implications can you imagine in other pharmaceutical cases or other industries, for that matter?
MARCIA COYLE: The decision is probably going to make it harder for business to use preemption as a defense where Congress has not expressly stated that federal law preempts state law. And it will have an impact, I believe, in cases outside of the pharmaceutical industry, in just about any area in which the federal government regulates.
JEFFREY BROWN: What kind of businesses are we talking about that could apply to state court now?
MARCIA COYLE: OK, we're talking about areas involving transportation, the regulation of motor vehicles. We're talking about railroads. The environment, that area, chemicals, pesticides, as well as consumer products, regulated by the Consumer Product Safety Commission.
JEFFREY BROWN: All right, Marcia Coyle, thanks again.
MARCIA COYLE: My pleasure.