Supreme Court Considers|Childhood Vaccine Case

WASHINGTON (CN) - The Supreme Court on Tuesday questioned whether federal law allows Pennsylvania parents to seek damages from Wyeth in state court for making a vaccine that allegedly caused their daughter to develop a seizure disorder.

Attorney David Frederick, arguing for the parents of an infant girl who received Wyeth's Tri-Immunol vaccine in 1992, said the family should be able to seek relief under state tort law after being denied relief in federal court, because their daughter's injury was not "unavoidable" under federal preemption standards.

The National Childhood Vaccine Injury Act, enacted in 1986, preempts design-defect claims against vaccine manufacturers "if the injury or death results from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Frederick said the injury was avoidable because it could have been prevented with the use of a safer vaccine, which he said Wyeth owned the rights to but never marketed.

Wyeth says a safer vaccine did not exist.

Frederick said the Act ensures that the vast majority of vaccine injury claims would be channeled through federal Vaccine Court, which provides compensation for vaccine-related injuries, but argued that design-defect claims should be looked at on a case-by-case basis.

He argued that Congress enacted the law to develop a national response to vaccines, but "not to displace state law completely."

Tri-Solgen, a vaccine sold in the 1960s by Eli Lilly, was shown to have far less serious effects, and Wyeth purchased the rights to the vaccine but abandoned testing because it determined it would not be as profitable as the company wanted, Frederick said.

Justice Stephen Breyer pointed out a statement by the American Academy of Pediatrics and 21 other physician and public health organizations that if Frederick wins, certain vaccines would be driven from the market, "and basically, a lot of children will die."

Frederick countered that 99 percent of those who receive monetary judgments in vaccine court accept their award, with manufacturers only facing a state lawsuit in "rare circumstances."

But Chief Justice John Roberts said, "It would depend, I suppose, on what they thought the judgments were going to be in the 1 percent of the time. It doesn't take too many $60 million verdicts to make you come out on the other side of your calculus."

Kathleen Sullivan, arguing for Wyeth, said the Act was enacted to counter a wave of tort litigation, such as the type of design-defect claims brought by the plaintiffs, which threatened to push vaccines out of the market.

She said the Act completely preempts design-defect claims, while allowing for manufacturer and warning defect claims.

Justice Ruth Bader Ginsburg said if Congress only intended to allow claims for manufacturing and warning defects it would have simply stated that no vaccine manufacturer is liable if the vaccine is properly prepared and labeled.

"That would have been the simplest statement," Ginsburg said. "Congress didn't make that statement ... the language that they used is, certainly, to say the least, confusing."

Sullivan said the government's position is that because the statute only mentions manufacturing and warning defects, Congress meant to preempt the third type of product liability claim, design defects.

She said if design-defect claims were allowed to go forward, vaccine manufacturers would be left in the "exact same place" that they were before the Act: in state court.

Assistant Solicitor General Benjamin Horwich, arguing for the government, said the word "unavoidable" in the Act meant that products that are socially beneficial but also have adverse effects should be on the market and "we ought not to allow tort law to push them off."

Horwich said the federal Centers for Disease Control and Prevention publishes a weekly report of the best vaccines available and makes ongoing comparative determinations of vaccines, including tracking and monitoring adverse events.

He said it would be "extraordinary" to think Congress wanted juries to second-guess decisions made by the government on vaccine safety.

Frederick said he was not sure if the CDC did the kind of "granular comparisons" that related to his case, in which he was trying to eliminate some of the most "horrifying and horrible incidents of injury from vaccines that we compel children to take."

Wyeth voluntarily took Tri-Immunol off the market in 1998.

The case is 09-152, Bruesewitz v. Wyeth.

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