The U.S. Supreme Court took up a major case on Tuesday about whether parents can sue in state courts over design defects in child vaccines, or whether a federal vaccine law precludes such claims.
While the case doesn’t directly involve autism, the lawsuit is being closely watched by the autism community, where many parents believe that thimerosal-containing vaccines and the vaccine for measles, mumps, and rubella (MMR) are a cause of autism in their children.
That debate has been followed by educators, with most scientific research failing to find such a link. A special court in Washington has found in several test cases that there is no persuasive evidence for a link between childhood vaccines and autism. The decisions by the U.S. Court of Federal Claims in the autism cases are available here.
The issue in the case before the Supreme Court, Bruesewitz v. Wyeth Inc. (Case No. 09-152), is whether a provision of the National Childhood Vaccine Injury Act of 1986 precludes liability for certain claims against vaccine manufacturers even if the vaccine’s side effects were avoidable.
Hannah Bruesewitz, now 19, suffered seizures and has had developmental disabilities since having a bad reaction to a diphtheria-tetanus-pertussis (DTP) vaccine known as Tri-Immunol as an infant in 1992.
Lawyers for the family contend that the vaccine, developed in the 1940s, had long been superseded by a more modern design, but that the drug manufacturer declined to change its DTP vaccine’s design because it viewed the economic costs as outweighing any potential gain in market share. Wyeth, now part of Pfizer Inc., withdrew Tri-Immunol from the market in 1998.
“We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury to vaccines that we compel children to take,” David C. Frederick, the lawyer for the Bruesewitz family, told the justices during oral arguments. “And the whole idea behind Congress’s scheme was to balance having vaccine supply available with providing a generous form of compensation to those persons who would be injured.”
Frederick was alluding to the 1986 federal vaccine law’s establishment of a special federal “vaccine court” and a compensation fund set up for those who suffered injuries. Many parents have been dissatisfied with the federal scheme and have sought to sue drug manufacturers in state courts.
A friend-of-the-court brief filed on the family’s side by groups such as Autism One and the National Autism Network argues that “the compensation program is not working as Congress intended.”
“Given the compensation system’s inadequacy, keeping the courthouse doors
open, as Congress intended, is more important than ever,” the brief says.
Kathleen M. Sullivan, the lawyer representing Wyeth, suggested during the arguments that if the court allows state tort lawsuits against vaccine manufacturers, the autism community is prepared to flood the courts.
“There are 5,000 claimants in vaccine court now who claim there is a relationship between the mumps, measles, and rubella vaccine and autism,” Sullivan said. “They have lost all six test cases [in the federal vaccine court] and when the individual cases are resolved, that is 5,000 potential claimants in state court[s].”
The justices appeared torn over the case, with some appearing to agree with the family’s arguments that Congress did not clearly preempt state tort lawsuits in this area when it passed the 1986 law.
“If Congress had wanted to [make it clear there could be no liability for design defects], they could have said simply that no vaccine manufacturer may be held civilly liable if the vaccine is properly prepared and accompanied by proper directions and adequate warnings,” Justice Ruth Bader Ginsburg told Sullivan. “That would have been the simplest statement. Congress didn’t make that statement.”
But Justice Stephen G. Breyer cited a friend-of-the-court brief on Wyeth’s side by the American Academy of Pediatrics and other medical groups, who argued that “by eliminating the threat of most lawsuits, the Vaccine Act has kept manufacturers from abandoning vaccine production.”
Justice Breyer told Frederick, the lawyer representing the Bruesewitz family: “What the pediatricians here say is that, if you win, we’re turning this over to judges and juries instead of the FDA and other specialized agencies, that the result could well be driving certain vaccines from the market, and basically, a lot of children will die.”
Justice Elena Kagan is not participating in the case because she worked on a federal brief while she was U.S. solicitor general. That leaves the potential for a 4-4 tie, which would result in the lower court ruling in favor of Wyeth being automatically affirmed.