WASHINGTON — People injured by vaccines that they say were improperly designed must rely solely on a compensation system created by a 1986 law and may not sue vaccine manufacturers, the Supreme Court ruled on Tuesday.
The vote was 6 to 2. Justice Elena Kagan recused herself because of her work on the case as United States solicitor general.
Justice Antonin Scalia, writing for the majority, said Congress had meant to establish a societal bargain in the 1986 law. “The vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries,” he wrote. “In exchange they avoid costly tort litigation and the occasional disproportionate jury verdict.”
In a vigorous dissent, Justice Sonia Sotomayor accused the court majority of imposing “its own bare policy preference over the considered judgment of Congress” depriving “vaccine-injured children of a key remedy that Congress intended them to have.”
The issue in the case was whether the compensation system created by the 1986 law displaced, or pre-empted, ordinary injury suits brought under state law. The Roberts court has been hearing many pre-emption cases under other laws, and decisions on ones concerning immigration, arbitration and seat belts are expected this term.
The case before the court, Bruesewitz v. Wyeth, No. 09-152, was brought by the parents of Hannah Bruesewitz, who received a vaccine known as D.T.P. as an infant in 1992. The vaccine offers protection against diphtheria, tetanus and pertussis, or whooping cough. She suffered seizures and has had developmental problems and seizure disorders since.
Ms. Bruesewitz’s parents filed a petition under the compensation program created by the 1986 law. They lost, on the ground that they had not proved that the vaccine caused their daughter’s injuries. Then they sued in state court in Pennsylvania. The case was moved to the federal courts, which have ruled that their claims are pre-empted by the 1986 law.
The case turned on the proper interpretation of a provision of the law that bars ordinary lawsuits “if the 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.”
Justice Scalia acknowledged that “Congress could have more tersely and more clearly pre-empted design-defect claims.” But he said the meaning of the passage was not in doubt. “If a manufacturer could be held liable for failure to use a different design,” Justice Scalia wrote, “the word ‘unavoidable’ would do no work.”
Chief Justice John G. Roberts Jr. and Justices Anthony M. Kennedy, Clarence Thomas, Stephen G. Breyer and Samuel A. Alito Jr. joined the majority opinion.
Justice Breyer also wrote a separate concurrence. “The textual question considered alone is a close one,” he said. But other factors — the drafting history and purpose of the law, the views of a federal agency and “expert medical opinion” — supported the majority’s conclusion, Justice Breyer wrote.
Allowing a jury to make decisions about vaccine design, he said, would “substitute less expert for more expert judgment.”
Justice Sotomayor, joined by Justice Ruth Bader Ginsburg, said the majority opinion “disturbs the careful balance Congress struck between compensating vaccine-injured children and stabilizing the childhood vaccine market.”
Justice Sotomayor said she understood the word “unavoidable” differently in the context of the law than Justice Scalia did. She said it indicated that Congress must “have intended a vaccine manufacturer to demonstrate in each civil action that the particular side effects of a vaccine’s design were ‘unavoidable.’ ”
The effect of Tuesday’s decision, Justice Sotomayor continued, was to leave “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.”
In a final footnote, Justice Sotomayor wrote that a concern about an asserted link “between certain vaccines and autism spectrum disorders” appeared to “underlie the majority and concurring opinions in this case.”
Wyeth, the defendant in the case, had told the justices that some 5,000 pending petitions concerned autism-related injuries and that it feared a “crushing wave” of litigation. Justice Sotomayor said she discounted those “doomsday predictions.”
In any event, she said, “Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines.”
Wednesday, February 23, 2011
From The NY Times:
Posted by BA Haller at 1:15 PM