The Supreme Court has ruled against the family of an infant who suffered from 125 seizures over 16 days as a result of a vaccine. In a 6 to 2 decision, the court ruled that under the National Childhood Vaccine Injury Act of 1986, drug companies are immune from lawsuits brought by plaintiffs seeking compensation for injury or death as a result of being vaccinated.
The 1986 act is designed to protect drug companies from liability lawsuits to ensure that drug companies do not shy away from producing vaccines out of fear of liability claims. To balance out the law, congress created a special vaccine court to provide funds for infants and children who have an adverse reaction to a vaccine. An excise tax placed on every vaccine is used to fund this special vaccine court.
While the majority of infant vaccines are safely administered, families submit between 100 and 200 claims for compensation to this special vaccine court each year. Currently, over $1.8 billion has been granted to 2,500 petitioners with the average amount of compensation being $750,000.
In April of 1992, the Bruesewitzes went to have their then-healthy infant Hannah to get her third round of DTP which prevents diptheria, tetanus and pertussis (whopping cough). The same afternoon, Hannah's mother Robalee Bruesewitz, discovered her daughter having violent seizures. The family sought compensation from the vaccine court in April of 1995 but was turned down.
DTP was known to cause seizures. But despite this knowledge, the Department of Health and Human Services removed seizures from the list of symptoms covered under the Vaccine Injury Act for DTP just a month before the Bruesewitzes applied for compensation.
The Bruesewitzes decided to sue Wyeth Inc., the vaccine manufacturer responsible, for negligence claiming Wyeth long had a safer version of the vaccine but failed to put it on the market. Russel Bruesewitz claimed that Wyeth withheld the safer version because profits superseded the safety of children. Wyeth Inc. countered that the Vaccine Injury Act forbids such claims to be made in court.
The Vaccine Injury Act was created to prevent open-ended money damages to vaccine manufacturers however Congress did not spell out which cases could go through and which cases were to be thrown out. The law states:
"No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
According to products liability law, there are three circumstances where a company can potentially be held liable. First, if there is a defect in the manufacture; second, if there were inadequate warnings and third, for defective design. The law, as stated above, does not include "defective design" leaving the Supreme Court to interpret why Congress left this out.
The majority came to interpret the law by meaning that drug manufacturers were immune to all design defect lawsuits if the manufacturing process did not create a defect and that adequate warnings were given and directions were correct.
In the dissent, Justices Sotomayor and Ginsburg said that Congress had intended vaccine manufacturers to face a continued "legal duty" to improve their vaccines with advancements of science and technology. Because of this interpretation, drug manufacturers no longer have a legal responsibility to improve vaccines as these already bring in high profits with little competition.
Wyeth Inc. pulled the vaccine in 1998 in favor of the safer version. But for Hannah Bruesewitz, this action comes too late. She now suffers from permanent developmental disability where she is completely non verbal and will need 24 hour assistance for the rest of her life.
Photo by John Heller/Post-Gazette