In a major victory for vaccine drug manufacturers, the U.S. Supreme Court ruled 6-2 February 22 against a family seeking compensation in federal court for an alleged design-defect in a children’s vaccine that caused long-term developmental damage to the family’s daughter.
The vaccine court, created by Congress in 1986 to handle the then-increasing wave of lawsuits against vaccine drug manufacturers, had rejected the family’s claim.
“We hold that the National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects,” wrote Justice Antonin Scalia in the majority opinion.
After taking a diphtheria, tetanus and pertussis vaccine prior to turning one-year old, the daughter suffered more than 100 seizures during the next month, eventually being diagnosed with residual seizure disorder. The family sought claim in the vaccine court against Lederle Laboratories, which was later bought by Wyeth and is now part of Pfizer.
In product liability law, companies can be held responsible for problems with their product if there is a defect with how to product is manufactured, if there are inadequate warnings, or if there is a defective design.
The National Childhood Vaccine Injury Act states that “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.”
The Supreme Court, affirming decisions at the district and appellate level, ruled the seizures were an unavoidable side effect, that the FDA’s licensing of the drug is proof it was properly manufactured and Lederle had provided the proper warnings.
In regard to Congress’ omission relating to defective designs, the opinion stated “The language of the provision thus suggests that the design of the vaccine is a given, not subject to question in the tort action.”
In their dissenting opinion, justices Sonia Sotomayor and Ruth Bader Ginsburg argued Congress never intended that level of immunity for vaccine drug manufactures.
Prior to the creation of the court, which is part of the U.S. Court of Federal Claims, more than 200 lawsuits were filed per year in the 1980s against manufacturers of diphtheria, tetanus, and pertussis vaccines, resulting in two of the three domestic manufacturers for these vaccines leaving the country.
Roughly 100 to 200 claims are submitted to the court each year, according to an article in the Christian Science Monitor. The court has paid out more than $1.8 billion to about 2,500 petitioners, with the average award equaling $750,000.