October 13, 2010
The Supreme Court seemed divided Tuesday on whether allowing lawsuits by people allegedly harmed by the side effects of childhood vaccines would hurt the general public by exposing drug companies to so much risk that they would leave the business.
The justices agreed that Congress has gone to great lengths to shield vaccine-makers from suits by the few who have had an adverse reaction to a vaccine approved by the Food and Drug Administration.
The issue is whether those hurt by vaccines have a right to sue manufacturers if they can prove that a safer version was available.
“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,” said David C. Frederick, a Washington lawyer.
He represents the parents of Hannah Bruesewitz, 18, who began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth’s Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.
But Russell and Robalee Bruesewitz, whose daughter will require lifelong care, have been unable to scale the obstacles that Congress put in the way of those trying to sue vaccine-makers.
The National Childhood Vaccine Injury Act of 1986 said all such claims must first go to a special tribunal commonly called the “Vaccine Court.” The tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine caused Hannah’s problems.
The couple then sued under Pennsylvania tort law. But federal courts said the suit could not proceed, because federal law prohibits claims against “design defects” in vaccines.
The question before the Supreme Court is whether that is correct, or whether Congress left some remedy for those who say injury or death could have been avoided if the manufacturer had offered a safer vaccine.
Kathleen Sullivan, representing Wyeth, told the court that Congress’s intent was clear and that it acted “against the backdrop of a wave of tort litigation that threatened to drive manufacturers out of the business of providing the vaccine.”
She said the ruling will be important for the future as well. “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, and when the individual cases are resolved, that is 5,000 potential claimants in state court.”