For the past 24 years, the National Childhood Vaccine Injury Act has protected vaccine manufacturers from being sued for most injuries caused by their products, but a Supreme Court case brought Tuesday by parents of allegedly vaccine-injured Hannah Bruesewitz may challenge this liability safeguard.
Robie and Russell Bruesewitz are suing vaccine manufacturer Wyeth (now part of Pfizer) for using an allegedly outdated and flawed vaccine design for the DPT vaccine their daughter received in 1992 -- a vaccine they claim is responsible for Hannah's residual seizure disorder, according to court documents.
Cases concerning vaccine safety design are normally handled by the federal "vaccine court," a no-fault compensation program set up by the 1986 Vaccine Injury Act to shield manufacturers from liability for injuries or death "resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
When the vaccine court rejected their case in 2002, on the grounds that her particular disorder was no longer a presumed vaccine-related injury, the Bruesewitzes sued Wyeth anyway and have appealed continued rejection of their claim all the way to the Supreme Court.
Now the Supreme Court must decide whether suits over flaws in design of a vaccine bypass the vaccine courts set up in 1986. If so, manufacturers will be opened up to an increased liability that some doctors fear might scare companies away from producing much-needed vaccines, as was the case before the 1986 Vaccine Injury Act.
Seven out of the eight vaccine manufacturers had stopped making vaccines before the act was put in place in the 1980s says Dr. Paul Offit, chief of the Division of Infectious Diseases at the Children's Hospital of Philadelphia . With the help of vaccine court, there have been "two decades of new vaccine research and development" and it would be "a disaster" if the court were done away with, he says.
"The whole system of vaccine injury compensation was set up 24 years ago because the entire vaccine industry was threatened by lawsuits -- all that uncertainty actually resulted in several companies leaving the vaccine market," says Dr. William Schaffner, chairman of Preventive Medicine at Vanderbilt University.
"We were threatened in the U.S. of not having a viable vaccine industry, which is critical in times of pandemic, never mind routine prevention against diseases that are still rampant in the rest of the world. It was serious enough that congress created this excellent, rigorous system," he says.
The Bruesewitz case has raised concerns in the medical community that a win for the family may undermine the vaccine court and the protection it supplies manufacturers.
Currently, issues of vaccine design are generally considered off limits for civil liability suits, but this case questions the breadth of the vaccine court's protection of manufacturers.
If the Supreme Court decides that vaccine design is outside of the "unavoidable" side effects listed in the Vaccine Injury Act, some health organizations fear this could mean a flood of other civil court cases brought on similar charges.