Supreme Court rules against parents in vaccine case

By Joan Biskupic and Liz Szabo, USA TODAY

 

WASHINGTON — The Supreme Court ruled Tuesday that the parents of a child who suffered seizures after a routine vaccination cannot sue the drugmaker.

By a 6-2 vote, the justices said a 1986 law that set up a special court and compensation fund for injuries stemming from vaccines bars all design-defect lawsuits against vaccine manufacturers.

The American Academy of Pediatrics, which along with the U.S. government had urged the court to bar such lawsuits, said the decision will enhance the national immunization system and ensure "that vaccines will continue to prevent the spread of infectious diseases in this country."

Lawyers who represent children who have suffered adverse effects, including the American Association for Justice and Public Citizen, said the ruling is a disincentive for manufacturers to put safer vaccines on the market.

The case against Wyeth, now owned by Pfizer, began in Pennsylvania, brought by Russell and Robalee Bruesewitz. Their daughter Hannah began suffering seizures in 1992, when at 6 months she was injected with a Wyeth-made vaccine for diphtheria, tetanus and pertussis (DTP). Hannah, now 19, has been developmentally impaired since.

Lower federal courts had thrown out the suit, and Tuesday the high court affirmed. The Bruesewitz family had gone first to the vaccine court, but that court said they failed to show the seizures were caused by the DTP vaccine.

Justice Antonin Scalia, who wrote for the majority, said the National Childhood Vaccine Injury Act was intended to protect against injuries yet "stabilize" a vaccine industry racked by vaccine-related litigation. It aimed to provide a balance between compensation for children's injuries and protection for drugmakers from litigation.

He noted that the law made it relatively easy for families with claims of side effects to win awards from a fund created by a tax on drugmakers. At the same time, the law shielded manufacturers from liability in court.

The disputed text at the core of the Bruesewitz case says that "no vaccine manufacturer shall be held liable in a civil action" for any injury that "resulted from side effects that were unavoidable." The majority read that to override all design-defect claims.

Scalia was joined by Chief Justice John Roberts and Justices Anthony Kennedy, Clarence Thomas, Stephen Breyer and Samuel Alito.

Justices Ruth Bader Ginsburg and Sonia Sotomayor dissented. In a statement by Sotomayor, signed by Ginsburg, they said the vaccine act did not clearly block lawsuits for design defect. They said drugmakers had long been subject to litigation and the "duty ... to improve the designs of their vaccines."

Justice Elena Kagan, who had been U.S. solicitor general, took no part in the case.

Pfizer Executive Vice President Amy Schulman praised the decision, stressing that "expert federal agencies" should determine "the optimal design of lifesaving childhood vaccines."

Washington lawyer David Frederick, who represented the Bruesewitz family and its claim that an outdated design caused Hannah's injuries, said the decision lifts any incentive for drugmakers "to comport with the most recent scientific advances in designing safer vaccines."

There was more at stake Tuesday than a single case, says Paul Offit, head of infectious diseases at Children's Hospital of Philadelphia and inventor of a vaccine against rotavirus, a diarrheal illness. He called it "a very good day for kids and parents."

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