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 David 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 John Roberts 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 Anthony 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 Sonia 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, Stephen Breyer, Ginsburg and Chief Justice Roberts, 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.