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Supreme Court Weighs Whether Vaccine Makers Can Be Sued

October 12, 2010 at 12:00 AM EDT
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Marcia Coyle of the National Law Journal talks about Supreme Court arguments on whether drug companies that make vaccines can be sued.
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JIM LEHRER: The U.S. Supreme Court heard arguments today about legal protections for vaccine manufacturers.

The issue today was whether vaccine makers should continue to be shielded from most lawsuits for damages. The arguments involved 18-year-old Hannah Bruesewitz of Mount Lebanon, Pennsylvania. Her parents blame her neurological problems on a childhood vaccine. They want to sue Wyeth Labs, which now owns the company that made the medicine.

The National Childhood Vaccine Injury Act, passed by Congress in 1986, established a no-fault system of compensation in such cases. The law set up a special vaccine court to confirm injuries and to award damages accordingly. The goal was to shield drug companies from repeated lawsuits, and thereby guarantee steady supplies of vaccine.

In recent years, hundreds of lawsuits have charged a link between childhood vaccines and autism. That means the case argued at the Supreme Court today could have far-reaching implications. It also comes as broader questions about vaccines are very much in the public sphere.

Last month, the Centers for Disease Control found U.S. immunization rates for most common childhood vaccines remain near or above the target of 90 percent coverage. But some states, most notably California, have seen cases of whooping cough increase this year, while vaccination rates have dropped.

And, again, here is Marcia Coyle of “The National Law Journal.” Marcia, welcome.

MARCIA COYLE, “The National Law Journal”: Hi, Jim.

JIM LEHRER: What — who brought this? Which side brought this case to the Supreme Court?

MARCIA COYLE: The Bruesewitz family came to the Supreme Court after losing in the lower federal courts.

Jim, this is basically a battle over a specific type of lawsuit that the family would like to bring, a suit claiming that the vaccine was defectively designed. And both sides, the family and Wyeth, the vaccine maker, are looking at the same provision in the federal law, and reading it completely different ways.

The family is saying that the provision allows them and other families like them to bring this type of a claim in state courts and have judges decide on a case-by-case basis whether the vaccine was defectively designed. Wyeth Laboratories says this exact same language here bars those types of claims.

JIM LEHRER: Because of that vaccine law, right?

MARCIA COYLE: That’s right. And…

JIM LEHRER: And they’re supposed to go the vaccine court, and they did go to the vaccine court first in this case.

MARCIA COYLE: They did. And the vaccine court found that the vaccine didn’t cause the injuries to their daughter. They’re allowed — even someone who wins in the vaccine court, if they’re not totally happy with the court’s judgment, they are allowed in certain cases to go into state or federal court to bring claims.

The question is, can they bring a design-defect claim? And that’s what the sides were fighting over here.

JIM LEHRER: All right. Give us the plaintiff’s case. What was the family’s argument? And who made it?

MARCIA COYLE: The family was represented by David Frederick. And he argued that the language here allows the family to go into state court and have the courts decide on a case-by-case basis whether the side effects of this vaccine were, using the word in the statute, unavoidable. That opens it up to judges.

The court…

JIM LEHRER: Whether or not it’s unavoidable or not.

MARCIA COYLE: Right. The court, a number of the justices seemed to feel that the language here is ambiguous, that Congress wasn’t really clear whether it wanted to bar this type of a lawsuit.

But Justice Breyer sort of went to the heart of the case here when he asked Mr. Frederick, assuming that the language is ambiguous, how do you answer an argument made by the American Academy of Pediatricians, who say that, if the family wins, vaccine makers are going to be chased from the market, children are going to die, and this isn’t what Congress wanted when it enacted the vaccine law?

JIM LEHRER: Well, explain, what would the chain be, that there would be so many lawsuits that pharmaceutical companies would just quit making vaccines; it would be to risky for them legally and financially?

MARCIA COYLE: Right. Wyeth’s counsel, Kathleen Sullivan, said that this type of lawsuit, design defect, was exactly…

JIM LEHRER: Design defect.

MARCIA COYLE: Right, defectively designed vaccine.

JIM LEHRER: OK. In other words, somebody made a mistake when they made the vaccine.

MARCIA COYLE: Yes, exactly.

JIM LEHRER: OK. All right.

MARCIA COYLE: Exactly.

JIM LEHRER: Go ahead. Yes.

MARCIA COYLE: And that there may be safer alternatives available.

JIM LEHRER: Sure.

MARCIA COYLE: But Ms. Sullivan said that this was the exact kind of lawsuit that Congress was worried about back in the 1980s, when vaccine makers faced an onslaught of personal injury suits resulting from vaccines. So, they enacted this law in order to bar this type of lawsuit.

JIM LEHRER: This very thing, yes. All right, now, what did — you mentioned what Justice Breyer said.

MARCIA COYLE: Yes.

JIM LEHRER: How did the — now, there were only eight justices hearing this case, right? Explain why.

MARCIA COYLE: That’s correct. Justice Kagan, Elena Kagan…

JIM LEHRER: The new one, right.

MARCIA COYLE: … the newest justice, she recused herself, she stepped out of the case because she was involved in the case when she was solicitor general of the United States.

JIM LEHRER: Representing the U.S. government, yes.

MARCIA COYLE: That’s right. The United States here, by the way, has participated in this case. The Obama administration is supporting Wyeth Laboratories, saying that this lawsuit is barred. So, there are eight justices. There could have been seven. The chief justice had recused himself…

JIM LEHRER: John Roberts, yes.

MARCIA COYLE: … in the initial stages because he owns stock in Wyeth. And he sold the stock in order to participate now. Eight justices isn’t great, because you can have a 4-4 split. Seven would be even worse.

JIM LEHRER: I was going to ask you about it. If it does go 4-4, Wyeth wins, right?

MARCIA COYLE: Absolutely. The lower court judgment stands.

JIM LEHRER: OK, because that — all right. But what happened in the courtroom today?

MARCIA COYLE: OK. Mr. Frederick told Justice Breyer, for example, that vaccine makers aren’t going to be chased from the market if this type of lawsuit goes forward. He said that the vaccine court channels just about all the vaccine claims. And 99 percent of those who go through the vaccine court accept what the vaccine court says about compensation.

JIM LEHRER: They don’t take it to another court?

MARCIA COYLE: No, they don’t. And he said this type of lawsuit is very, very hard to prove. And those two factors, taken together, will not open — will not chase the vaccine makers out of the market.

JIM LEHRER: Now, what did the other justices say, if anything, that you thought was memorable?

(LAUGHTER)

MARCIA COYLE: OK. Justice Ginsburg pressed Wyeth’s attorney, Ms. Sullivan, a couple times, saying, well, you know, if Congress had meant to block these lawsuits, it would have said so. But it didn’t.

JIM LEHRER: It wouldn’t have left it ambiguous.

MARCIA COYLE: Exactly.

And there is a presumption that the court has applied over the years in these cases, a presumption against federal law preempting state law. So she just felt that, if Congress wanted to preempt it, it would have said that clearly.

Justice Kennedy said, well, you know, maybe it was a sloppy drafting. Congress doesn’t always write clearly. And Ms. Sullivan said, well, they could have written more clearly, but she still reads the provision to block this type of lawsuit.

Justice Sotomayor raised some concerns here. She seemed somewhat sympathetic to the family here, feeling that, if you don’t have, say, these state lawsuits on defective designs, what is there to encourage vaccine makers to come forward when there are problems with the vaccine? Who is policing this? She tried several times to find out, what’s the role of the FDA? What’s the role of the Centers for Disease Control?

JIM LEHRER: So, final word here then is a coin toss? You couldn’t tell? You’re not making any predictions on this one?

MARCIA COYLE: I rarely do.

JIM LEHRER: I know.

MARCIA COYLE: And I think this one is close. And these preemption cases — and we have four this term — often split 5-4. So, it’s going to be very close.

JIM LEHRER: OK. And if — whichever way it goes, this is going to have a huge impact, is it not?

MARCIA COYLE: It does. And there is a real tradeoff here. If the family wins, vaccine makers will be sued in state courts and face potential liability that could tie them up for years. It could be costly. It could be disincentives to research and development.

But, if Wyeth wins, families like the Bruesewitzes, whose children have suffered significant or catastrophic injuries, will have no remedy.

JIM LEHRER: So, OK. So, that’s — that’s more than a coin toss.

MARCIA COYLE: That’s true. And another thing, too, you mentioned in your setup here that — autism cases.

JIM LEHRER: Yes.

MARCIA COYLE: Ms. Sullivan pointed out that there are 5,000 autism vaccine-related cases now in the vaccine court. And she raised the possibility that, depending on how the court rules, that could open another avenue for vaccine makers to be sued.

JIM LEHRER: It’s a big deal. And we will have a decision probably in the summertime, right?

MARCIA COYLE: Probably by June.

JIM LEHRER: OK. Marcia, thank you.

MARCIA COYLE: My pleasure.