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Robie and Russell Bruesewitz are suing vaccine manufacturer Wyeth (now part of Pfizer) for using an allegedly outdated and flawed vaccine design for the DPT vaccine their daughter received in 1992 -- a vaccine they claim is responsible for Hannah's residual seizure disorder,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.
In an Amicus brief to the Supreme Court in July, the American Academy of Pediatrics along with dozens of other health organizations wrote in support of the vaccine injury compensation program, noting that returning to a case-by-case procedure of evalulating vaccine safety could threaten the ability of manufacturers to properly supply vaccine.
Pfizer, who bought Wyeth in 2009, writes in a press release that the company "hope[s] that the Supreme Court will affirm Wyeth's victory in the lower courts, which held that the National Childhood Vaccine Injury Act places the responsibility for determining the optimal design of life-saving childhood vaccines in the hands of expert federal agencies, not a patchwork of state tort systems."
The intention of the compensation program was to provide compensation for those harmed by vaccines while allowing manufacturers to operate and develop new, hopefully safer, vaccines without undue threat of liability.
The compensation program is funded by a surcharge put on every vaccine that is sold, not by taxpayer or by manufacturer's money and expert judges, called special masters, review petitions and aware compensation to those injuries or deaths deemed genuinely caused by vaccines.
"There's an understanding that when you vaccine people, there are certain number of individuals who may sustain a vaccine injury," Schaffner says, and the act set up an "ethical" and "rigorous" way of compensating these individuals.
While many doctors view this special compensation court has been a great success, it does leave those whose claims have been rejected by the vaccine court with little recourse -- an issue that vaccine critics and skeptics feel is highlighted by the Bruesewitz case.
The intentions of the vaccine court were "proper and good" but in reality the system has become an "antagonistic process" against victims and their families, says Neil Miller, director of Thinktwice Global Vaccine Institute, an advocacy group for vaccine education and the freedom of parents to refuse vaccines for their children.
Miller feels that by putting in place a no-fault system for addressing vaccine safety the vaccine courts have "created a disincentive for the manufacturers to make safer vaccines."
"As it stands now, I think these vaccines are not being investigated enough in terms of their safety profiles," he adds. "I would like to see parents have the ability to take manufacturers directly to court, as they would for the maker of any other dysfunctional or negligent products."