The U.S. Supreme Court ruled on Tuesday against the parents of Hannah Bruesewitz, 18, who suffered seizures and permanent brain damage after receiving a diptheria-tetanus-pertussis (DTP) vaccine in 1993. The Bruesewitz family had sued Wyeth who was then the parent company of the maker of the DTP vaccine that Hannah received as an infant.
The Court said vaccine makers cannot be held liable for negative side effects that parents believe are the result of their products. They advised such aggrieved parents to go before special no-fault tribunals established by the National Childhood Vaccine Injury Act of 1986. Justice Antonin Scalia noted in the majority decision in Bruesewitz v. Wyeth that Congress created these “Vaccine Courts” with the participation of pharmaceutical companies as a sort of “societal bargain”. This was done to ensure the future of vaccine availability in the U.S. At the time of the Act, hundreds of injury lawsuits were piling up against vaccine manufacturers, causing them to abandon manufacture of major vaccines and threatening immunizations for the entire country. Sometimes the injured party could file for compensation without having to prove cause when the injury occurred immediately after vaccination. The injury had to be included in a list of side effects called a Vaccine Table, kept by the Vaccine Court. In exchange, pharmaceutical companies cannot be held liable in civil court for adverse effects, and there is a cap on how much claimants may be awarded. The fees come from taxes on immunizations.
This has also affected immunizations said Justice Scalia. In some regions of the country parents are increasingly refusing to vaccinate their children, influenced not only by the remote possibility of adverse reactions, but also by fringe activists who believe vaccines cause autism or other unrelated ailments. Justice Sonia Sotomayor, joined by Justice Ruth Bader Ginsburg, dissented. Justice Elena Kagan did not participate in the case because she worked on it before she joined the Court.
Hannah began having seizures within hours of receiving the third of a scheduled five doses of Wyeth's Tri-Immunol DTP vaccine, at 6 months old. Within 16 days, she had an additional 125 seizures. Her medical records included speech delays and “autistic-like features” among her symptoms. She now suffers from residual seizure disorder and remains developmentally impaired. Incidentally the DTP vaccine that Hannah received came from a batch associated with an unusually high number of adverse events, including one death and eight children who had convulsions. The Bruesewitzes took their case to a Vaccine Court in 1995, but were denied a settlement because residual seizure disorder was not one of the adverse events appearing on the Vaccine Table for DTP. The petition was dismissed in 2003. Ultimately, the case landed in the Supreme Court, which voted 6 to 2 in favor of vaccine makers on Tuesday.
Dr. Carl W. Bazil, neurology professor at Columbia University said, “The thing about epilepsy is that it’s often a seemingly random event. The human response is to try to find a reason. I’ve literally had people come in and say that their epilepsy has to do with the phases of the moon…Can I prove that epilepsy is never caused by vaccine? No. But as a neurologist I can say that it’s extremely unlikely.” The American Academy of Pediatrics welcomed this verdict and said it would safeguard the nation’s vaccine supply by protecting vaccine makers from potentially crippling legal liability - which could have driven manufacturers out of the vaccine market. Organization’s president, Dr. O. Marion Burton said, “Childhood vaccines are among the greatest medical breakthroughs of the last century… Today’s Supreme Court decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country.”
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