WASHINGTON - The U.S. Supreme Court ruled yesterday that a federal law bars lawsuits against drug makers over serious side effects from childhood vaccines.
By a 6-2 vote, the Court ruled against the parents of a child who sued the drug maker Wyeth in Pennsylvania state court for the health problems they say their daughter, now 19, suffered from a vaccine she received in infancy.
Justice Antonin Scalia, writing for the Court, said Congress set up a special vaccine court to handle such claims as a way to provide compensation to injured children without driving drug manufacturers from the vaccine market. The idea, he said, was to create a no-fault system that spares the drug companies the costs of defending against parents' lawsuits.
Justices Ruth Bader Ginsburg and Sonia Sotomayor dissented. Nothing in the 1986 law "remotely suggests that Congress intended such a result," Justice Sotomayor wrote, taking issue with Justice Scalia.
Justice Elena Kagan took no part in the case because she worked on it while serving in the Justice Department.
Justice Scalia's opinion was a stinging defeat for parents who found their award from the vaccine court insufficient or failed to collect at all.
Such was the case for Robalee and Russell Bruesewitz of Pittsburgh, Pa., who filed their lawsuit after the vaccine court rejected their claims for compensation. According to the lawsuit, their daughter, Hannah, was a healthy infant until she received the diphtheria, tetanus and pertussis vaccine in April 1992. The vaccine was made by Wyeth, now owned by Pfizer Inc.
Within hours of getting the DPT shot, the third in a series of five, the baby suffered a series of debilitating seizures. Hannah continues to suffer from residual seizure disorder, the suit says.
Justice Scalia said that when a vaccine is properly prepared and is accompanied by proper directions and warnings, lawsuits over its side effects are not allowed under the 1986 law.
"Vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries," he said. "In exchange they avoid costly tort litigation and the occasional disproportionate jury verdict."
The vaccine court has paid out more than $1.9 billion to more than 2,500 people who claimed a connection between a vaccine and serious health problems.
The drug companies worried that they would face a flood of lawsuits over the side effects of vaccines in the event of an unfavorable Supreme Court decision. They were especially concerned about claims from families of autistic children who say the vaccines, or mercury-based thimerosal that once was used to preserve them, are linked to autism. Numerous studies have addressed vaccines and autism and found no link, including with the preservative.
Pfizer praised the decision.
"We have great sympathy for the Bruesewitzes," said Amy Schulman, Pfizer executive vice president and general counsel. "We recognize, however, that the Vaccine Act provides for full consideration of the liability issues through the National Vaccine Injury Compensation Program. Here the Vaccine Court concluded that the petitioners failed to prove their child's condition was caused by vaccination."
David Frederick, who represented the Bruesewitz family at the Supreme Court, said, "I'm disappointed for the families of victims of defectively designed vaccines, who now have no remedy at law for their injuries."