Wyeth vaccine
© AP Photo/Mike Derer
In this Oct. 18, 2006 file photo, the lobby of the headquarters of pharmaceutical company Wyeth is shown in Madison, N.J. The Supreme Court ruled Tuesday that a federal law bars lawsuits against drug makers over serious side effects from childhood vaccines. The vaccine was made by Wyeth, now owned by Pfizer, Inc.
The Supreme Court closed the courthouse door Tuesday to parents who want to sue drug makers over claims that their children developed autism and other serious health problems from vaccines. The ruling was a stinging defeat for families dissatisfied with how they fared before a special no-fault vaccine court.

The court voted 6-2 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 in 1986 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 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," Sotomayor wrote, taking issue with Scalia.

Scalia's opinion was the latest legal setback for parents who felt they got too little from the vaccine court or failed to collect at all.

Such was the case for Robalee and Russell Bruesewitz of Pittsburgh, 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 lawsuit said.

A federal trial judge and the Philadelphia-based 3rd U.S. Circuit Court of Appeals ruled in favor of Wyeth. Indeed, state and federal appeals courts have almost always sided with the vaccine manufacturer in preventing the lawsuits from going forward.

Scalia confirmed that outcome Tuesday. He 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," Scalia said. "In exchange they avoid costly tort litigation and the occasional disproportionate jury verdict."

The American Academy of Pediatrics, representing more than 60,000 doctors, praised the decision. "Childhood vaccines are among the greatest medical breakthroughs of the last century," said Dr. Marion Burton, the group's president. "Today's Supreme Court decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country."

Pfizer also applauded the decision. "We have great sympathy for the Bruesewitzes," Pfizer Executive Vice President and General Counsel Amy Schulman said, "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."

But 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."

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 vaccine court is part of the U.S. Court of Federal Claims, which generally has jurisdiction over individuals' claims against the federal government. Under the 1986 law, the court appoints lawyers to serve four-year terms as special masters, and they hear claims of vaccine-related injuries and decide whether parents should be compensated. Those decisions can be appealed to the Court of Federal Claims and then the U.S. Court of Appeals for the Federal Circuit in Washington.

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.

Sotomayor said the drug companies' worry "seems wholly speculative." She said that parents already face "substantial hurdles" in winning compensation.

Sotomayor instead pointed to arguments made by Frederick, the family's lawyer, when the Supreme Court heard the case in October. He said that Congress did not explicitly rule out the kind of lawsuit the Bruesewitz family filed against Wyeth, asserting that the company was slow to move ahead with a safer vaccine because it would not be as profitable. Frederick said the threat of lawsuits would motivate drug companies to introduce safer vaccines more quickly.

Justice Elena Kagan took no part in the case because she had worked on it while serving in the Justice Department.

The case is Bruesewitz v. Wyeth, 09-152.