WASHINGTON -- Supreme Court justices struggled Tuesday with how to protect children from potentially dangerous side effects of vaccines yet avoid exposing drugmakers to a flood of groundless litigation.
No consensus emerged during robust arguments in the Pennsylvania case bought by the parents of a child who suffered seizures after a vaccination.
The dispute tests whether a 1986 law establishing a special U.S. court to review vaccine injuries overrides state-law claims against drugmakers for design defects in a vaccine. A ruling could affect numerous lawsuits seeking damages, including those from parents alleging a link between vaccines and autism.
Lawyer Kathleen Sullivan, representing the pharmaceutical company Wyeth in Tuesday's case, which is unrelated to the high-profile autism disputes, invoked those cases as she urged justices not to rule against Wyeth.
"There are 5,000 claimants in vaccine court now who claim there is a relationship between the mumps, measles and rubella vaccine and autism," she said. "Congress was worried about episodic waves of fear about vaccines leading to future litigation."
On the other side, lawyer David Frederick urged the justices to focus on Russell and Robalee Bruesewitz, whose daughter Hannah began suffering debilitating seizures in 1992, when at age 6 months she was injected with Wyeth's vaccine for diphtheria-tetanus-pertussis.
"We are talking about trying to eliminate some of the most horrifying and horrible incidents," he said, urging the justices to rule that parents can go to regular court.
The Bruesewitzes lost in the special court designed to hear vaccine-injury claims. That panel said the parents had failed to show the seizures were caused by the vaccine, as they had claimed.
The Bruesewitzes then filed a lawsuit based on Pennsylvania law. But a U.S. appeals court said the 1986 vaccine-injury law overrides state claims of a design defect. The ambiguously worded act says no "manufacturer shall be held liable in a civil action" for injuries "from side effects that were unavoidable."
Frederick said Wyeth could have given a safer vaccine but had not adopted it because of costs. Wyeth, now part of Pfizer, withdrew the drug Hannah took from the market in 1998.
Chief Justice John Roberts said Congress' establishment of a special court and compensation could mean it "didn't want to allow state-law claims."
Frederick said Congress did not seek to bar all claims, but rather wanted the case-by-case review.
Under questioning from Justice Anthony Kennedy, Frederick said Congress wanted most claims in the special vaccine court and allowed lawsuits on state grounds only in "rare circumstances like the problem we have here where the vaccine court awards nothing."
Kennedy noted the "tremendous expense" of litigation to manufacturers.
Justice Stephen Breyer asked whether more potential lawsuits might drive vaccines from the market and cause children to die. Frederick said most people claiming injuries accept the special vaccine court's verdict, so manufacturers would not be facing significant new liability. Sullivan said the law arose after "litigation that threatened to drive manufacturers out of the business."
Justice Sonia Sotomayor asked why, then, Congress did not clarify that the vaccine court was the exclusive route for remedies. She also asked whether drugmakers would have any incentive to design better drugs if they are only in a special court that limits liability.
The U.S. government is siding with Wyeth. Because of the government's role, Justice Elena Kagan, who had been U.S. solicitor general, did not take part. Only eight justices heard the case and could split 4-4. If that happens, the ruling against the parents would stand, but no standard for other cases would be set.
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