By Robert Barnes
Washington Post Staff Writer
Wednesday, October 13, 2010; A2
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."
But Sullivan faced tough and repeated questioning from Justices Sonia Sotomayor and Ruth Bader Ginsburg.
Without the prospect of a lawsuit, Sotomayor asked, "what is the motivation for manufacturers to voluntarily remove a drug that is causing harm to the public before the FDA acts?"
Sotomayor's repeated questioning indicated that she did not think Sullivan produced an answer.
Ginsburg said that if Congress had meant to exempt vaccine manufacturers from all suits, it could have simply done that. "Congress didn't make that statement," she said.
Frederick's tough questions came from Chief Justice John G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr.
When Frederick told the court that the industry was protected by Congress in 99 percent of the cases, Roberts wondered what the payouts might be in the 1 percent not covered and whether that would convince the vaccine makers that it was not worth their investments.
"It doesn't take too many $60 million verdicts to make you come out on the other side of your calculus," he said.
The government agrees with Wyeth and says Congress wanted to make sure that vaccines remain available. Assistant Solicitor General Benjamin J. Horwich said it is up to the Centers for Disease Control and Prevention to make decisions about whether there is a safer vaccine available than the one currently in use.
He said it would be "extraordinary" if Congress had preferred a system in which "juries would effectively be second-guessing decisions like that."
Justice Elena Kagan was recused from the case because of her past work on it when she was solicitor general. Roberts sold his holdings in Pfizer in August so that the case would not be heard by only seven justices.
The lack of a full court makes it harder for the Bruesewitzes. The justice Kagan replaced, John Paul Stevens, was one of the court's strongest believers in consumers' ability to sue in state courts. And Frederick must persuade five of the eight to overturn the U.S. Court of Appeals for the 3rd Circuit to allow the suit to proceed.
If the justices are evenly split, the judgment of the lower court is upheld, but it does not set a national precedent.
The case is Bruesewitz v. Wyeth.