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The Supreme Court granted review and has agreed to rule on the legal right to sue in state court by parents whose children have been injured by vaccines. The case concerns whether the National Childhood Vaccine Injury Act bars parents from suing the pharmaceutical company Wyeth over the side effects allegedly caused by its diphtheria, tetanus and pertussis vaccine.
The question presented is whether Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 - which expressly preempts certain design defect claims against vaccine manufacturers “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 warning” - preempts all vaccine design defect claims, regardless whether the vaccine's side effects were unavoidable. The plaintiffs claim their daughter developed a seizure disorder after getting the vaccine when she was six months old. The U.S. Circuit Court of Appeals for the Third Circuit dismissed their claims as preempted by the Act.
Although cast as a “preemption” issue (an issue which the U.S. Supreme Court has addressed in the context of drugs and medical devises “somewhat inconsistently” three times in the past two terms), this case raises very important public health policy issues. Vaccines are a cornerstone of public health and a very cost-effective way of dealing with numerous widespread and serious diseases. Any decision that discourages pharmaceutical companies from developing and producing vaccines will have a strong negative impact on public health and health costs.
The Foundation filed an amicus brief in support of Wyeth on behalf of a Nobel Laureate in Medicine., the dean of the University of Puerto Rico School of Public Health. The Dean emerita of the University of California School of Public Health, a former senior official of the World Health Organization, an official of the European Centre for Disease Control, and several other prominent health scientists. The purpose of our brief is to educate the justices about the importance of childhood vaccination to public health and to the health of the persons vaccinated, the relatively low risk of harmful side effect, and the cost-effectiveness of vaccination programs in the United States and worldwide.