The U.S. Supreme Court reinforced the shield that protects drugmakers from lawsuits over vaccines, ruling against two parents who blame Pfizer Inc.’s Wyeth unit for their teen-age daughter’s seizure disorder.
The justices, voting 6-2, said a 1986 federal law preempts claims that a drugmaker should have sold a safer formulation of a vaccine. The law, designed to encourage vaccine production by limiting patient suits, channels most complaints into a company-financed no-fault system that offers limited but guaranteed payments for injuries shown to be caused by a product.
“The vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries,” Justice Antonin Scalia wrote for the majority. “In exchange they avoid costly tort litigation and the occasional disproportionate jury verdict.”
The ruling is a victory for the four companies that supply vaccines for the U.S. market -- Wyeth, GlaxoSmithKline Plc, Merck & Co. and Sanofi-Aventis SA. A ruling letting the parents sue Wyeth might have allowed suits by thousands of families that say vaccines caused autism in their children. Since 1988, the no-fault process has led to almost $2 billion in compensation to more than 2,500 families.
The issue for the Supreme Court was whether the 1986 law leaves open the possibility that patients can sue manufacturers when the side effects were avoidable. The Obama administration joined Wyeth, acquired in 2009 by New York-based Pfizer, in urging the justices to bar those types of suits.
Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented. Sotomayor said the ruling “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.”
Justice Elena Kagan didn’t take part in the ruling.
Most lower courts that had considered the issue had reached similar conclusions, so the high court ruling won’t mark a change in much of the country.
The case concerned Hannah Bruesewitz, who as an infant began experiencing seizures after receiving the third of five scheduled doses of Wyeth’s Tri-Immunol diphtheria-pertussis-tetanus vaccine in 1992.
Her parents, Russell and Robalee Bruesewitz, sought compensation from the special court that handles vaccine claims. That court rejected the claim, saying there was no proof that the vaccine contributed to Hannah’s problems. The Bruesewitz family then took the case to federal court in Philadelphia.
“We have great sympathy for the Bruesewitzes,” Pfizer Executive Vice President Amy Schulman said in a statement. At the same time, she said the vaccine law “appropriately places the responsibility for determining the optimal design of life-saving childhood vaccines in the hands of expert federal agencies, not a patchwork of state tort systems.”
The family’s Supreme Court lawyer, David Frederick, said the ruling “eliminates the only mechanism for ensuring that manufacturers stop subjecting children to outmoded and unnecessarily dangerous vaccines.”
The American Academy of Pediatrics, which represents 60,000 doctors, hailed the ruling. President O. Marion Burton said the 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.”
The case is Bruesewitz v. Wyeth, 09-152.