The US Supreme Court bolstered support for vaccine manufacturers today by ruling that vaccine makers cannot be sued for design defects in vaccines outside of the special Vaccine Court established by Congress in 1986.
The case was brought by the parents of Hannah Bruesewitz, who claim that a vaccine against diphtheria, pertussis (whooping cough) sickened their daughter, causing seizures and long-term developmental problems. (See ‘US Supreme Court appears divided on vaccine case’ for more details.) The vaccine was made by Wyeth, a drugmaker that has since been acquired by New York-based Pfizer.
The case was closely watched because of its implications for the thousands of claims filed in Vaccine Court that argue a link between childhood vaccines and autism. A ruling in favor of the Bruesewitz family could have buttressed those claims.
“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," said O. Marion Burton, president of the American Academy of Pediatrics, in a statement.
Attorneys for the family argued that the vaccine Hannah received came from a lot that was associated with an unusually large number of side effects. (Wyeth discontinued the vaccine in 1998.) When the Vaccine Court refused to hear the case, the Bruesewitz family turned to the Pennsylvania state courts, eventually working their way up to the US Supreme Court.
But in a 6-2 decision today, the Supreme Court denied their claims. Writing for the majority, Justice Scalia said that the National Childhood Vaccine Injury Act, the legislation that created the Vaccine Court, “preempts all design defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects”.
The court emphasized lessons learned from the events which led to the creation of the Vaccine Court: a series of lawsuits between 1980 and 1985, after which two firms withdrew their whooping cough vaccine altogether, and other vaccine makers told Congress they also considered abandoning vaccines.
Justices Sotomayor and Ginsberg, however, argued that the ruling left consumers unprotected. The decision, they wrote, “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.”
Another vaccine case – this one alleging a young boy was harmed by the mercury used as a preservative in some vaccines – has also been appealed to the Supreme Court. The case is scheduled to be discussed in conference this week, after which the Court may decide whether or not to hear the case.