The U.S. Supreme Court has given a major legal victory to manufacturers of childhood vaccines by ruling that they cannot be sued in state court over injuries allegedly caused by a defective vaccine. The decision — applauded by many in the health care field who said it would help safeguard the nation’s immunization system — could block or narrow thousands of claims linking vaccines to autism and other problems in children.
The case decided by the court was filed by the parents of a Pennsylvania girl, Hannah Bruesewitz, who claimed she began to suffer seizures within 24 hours of being vaccinated in 1992, when she was six months old. Now 19, she is still diagnosed with “residual seizure disorder” and is developmentally impaired.
In the Bruesewitz case, the vaccine at issue was the DPT inoculation for diphtheria, pertussis and tetanus. But as The Wall Street Journal reported, the court’s decision “will have legal implications for the efforts to link vaccinations to autism.”
As a result of the ruling, an autistic child who alleges a vaccine caused the condition will not be able to sue the manufacturer on a “design-defect” tort claim in state court but will have to proceed exclusively through the “no-fault” system set up by the National Childhood Vaccine Injury Act, which Congress passed in 1986.
The act shields a vaccine manufacturer from liability if a vaccine-related injury or death “resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” The law also created a “vaccine court” to handle safety claims and ease the threat of expensive litigation in state courts against pharmaceutical companies. Compensation is paid to claimants out of a fund created by a tax on vaccine manufacturers.
A 6-2 majority of the Supreme Court ruled against allowing the Bruesewitz family to sue Pfizer Inc.’s Wyeth unit in state court for failing to market a “safer” version of the DPT vaccine.
“Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State law design-defect claims are therefore preempted,” Justice Antonin Scalia wrote for the majority.
Manufacturers can still be sued in state court for manufacturing a vaccine improperly or failing to provide adequate warnings. But Justice Sonia Sotomayor said in a dissent that the majority’s decision “leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”
She noted that manufacturers are concerned about “an onslaught of autism-related tort litigation” but said “Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines.”
The Bruesewitz family sought to pursue a claim against Wyeth in state court in Pennsylvania after the vaccine court rejected their claims, finding that they failed to show that the injuries were caused by the DTP vaccine. “Now the Supreme Court tells Hannah and her family that there is no courtroom in the country in which she can obtain justice and compensation for the years of care ahead that she needs,” the Coalition for Vaccine Safety, an advocacy group, protested in a news release.
However, the high court decision was hailed by organizations such as the American Academy of Pediatrics, which said it would help ensure the availability of disease-fighting vaccines for children. The Obama administration also supported Wyeth’s side in the case.
Advocates for families of autistic children had held out hope that the Supreme Court ruling could provide support for legal claims against vaccine manufacturers. There never has been a court ruling that vaccines specifically caused autism, but compensation has been awarded for children who suffered neurological symptoms common to autistic children.
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