Supreme Court Hears Case On Vaccine Lawsuits by Nina Totenberg

[Guest guest]

Supreme Court Hears Case On Vaccine Lawsuits

by Nina Totenberg

October 12, 2010

If manufacturers are to be driven out of business today, we'll see a resurgence

of infectious diseases that we've almost forgotten about in our time.

- Kathleen Sullivan, lawyer for Wyeth

These kinds of cases have been brought against vaccine manufacturers for 100

years. The Vaccine Act of 1986 was not intended to displace those claims. And so

we're talking about the very rare situation where an existing safer alternative

existed, and it caused a harm that could have been avoided.

- Frederick, lawyer for Bruesewitz family

At the U.S. Supreme Court on Tuesday, the justices heard arguments in a case

that drug manufacturers say could open the floodgates to thousands of lawsuits —

mainly from parents who contend that vaccinations caused their children's

autism. At issue is how far a federal law reaches in barring state lawsuits over

vaccines.

In 1986, Congress created a special no-fault compensation system for injuries

that result from vaccines. The payments are awarded by a special vaccine court.

The question presented by Tuesday's case is whether that court is the end of the

line for most claims, or whether Congress intended to give victims an additional

chance to prove their case and win damages in state court.

The case was brought by the parents of Hannah Bruesewitz. She was a healthy

6-month-old baby when she received a vaccination against diphtheria, tetanus and

pertussis. Within hours, she suffered scores of seizures and has been

developmentally impaired ever since. Her parents claimed her injuries were

caused by the vaccine, which was developed in the 1940s, and that the

manufacturer, Wyeth Pharmaceuticals, had declined to substitute another, safer

and more modern, vaccine. When the special vaccine court ruled that there was

inadequate proof the vaccine caused Hannah's injuries, her parents then sued in

state court, where they would have the right to subpoena drug company records to

learn what the drug company knew about the vaccine's safety. The lower courts,

however, threw the case out, declaring that the federal vaccine law barred all

suits over design defects.

On the steps of the Supreme Court on Tuesday, lawyer Frederick,

representing the Bruesewitz family, contended that a victory in this case would

cause no great harm to vaccine manufacturers.

" These kinds of cases have been brought against vaccine manufacturers for 100

years, " he said. " The Vaccine Act of 1986 was not intended to displace those

claims. And so we're talking about the very rare situation where an existing

safer alternative existed, and it caused a harm that could have been avoided. "

But lawyer Kathleen Sullivan, representing Wyeth, a division of Pfizer,

countered that a decision allowing suits like this one would imperil the health

of the nation.

" If manufacturers are to be driven out of business today, we'll see a resurgence

of infectious diseases that we've almost forgotten about in our time, " she

predicted.

Inside the court, lawyer Frederick got pummeled by justices from the right and

left.

Justice Ruth Bader Ginsburg asked him to respond to the government's argument

that there is no liability if a vaccine has Food and Drug Administration

approval.

Frederick replied that the government is " incorrect. Congress had choices. " It

could have barred suits alleging a design defect, but " it chose not to do that. "

In this case, argued Frederick, there was an alternative vaccine that was just

as effective, and posed fewer side effects, but the manufacturer did not make it

available because it couldn't make as much money off it.

So, asked Ginsburg, do manufacturers have to pursue a different vaccine,

regardless of cost?

Frederick answered that Congress set up a system in which vaccine makers are

" exonerated " in 99 percent of all cases, and few cases go to the state courts.

That, he said, is a good " bargain " that most manufacturers would gladly accept.

But Chief Justice pushed back. That, said the chief justice, would

depend on the award amount in the remaining 1 percent of the cases. " It doesn't

take too many $60 million verdicts to make you come out on the other side of

your calculus, " he added.

Justice Kennedy also challenged another of Frederick's assumptions. " You

assume there's no burden to the manufacturers who defend these suits, " he said.

But in fact, " this is a tremendous expense. "

While the justices seemed skeptical of Frederick's position, they turned with

equal ferocity on Sullivan, the lawyer representing Wyeth.

Justice Sotomayor pointedly asked: Why didn't Congress make the vaccine

court the " exclusive " vehicle for such claims?

Sullivan repeatedly insisted that Congress intended to do just that because

manufacturers were being driven out of business by lawsuits.

Faced with more difficult questions from Justices Kennedy, Breyer,

Ginsburg and Chief Justice , Sullivan threw down the gauntlet. She told

the justices that if they rule in favor of the Bruesewitz family, parents of

autistic children in some 5,000 cases could litigate their claims that the

disease was caused by the measles and mumps vaccine — despite the fact that the

vaccine court has repeatedly ruled there is no evidence of a link.

If Congress wanted to bar such suits, replied Justice Kennedy, why didn't it

just enact a ban " in plain words? " It was a question Sullivan heard over and

over again.

At day's end, there were few willing to bet on how the court will decide the

case.