Ethics Case Vaccines are biological preparations usually containing an agent that resembles a disease-causing microorganism, which is often administered by needle and which improves immunity to a particular disease. Vaccines are subject to federal premarket approval of the federal Food and Drug Administration (FDA). The elimination of communicable diseases through vaccination became one of the greatest achievements of public health in the twentieth century. However, harm caused by side effects to some individuals led to a massive increase in vaccine-related tort litigation against the manufacturers of vaccines. One group of manufacturers that was subject to such lawsuits was the manufacturers who made the vaccine against diphtheria, tetanus, and pertussis (DTP). Because of the lawsuits, two of the three domestic manufacturers of DTP withdrew from the market. In response, the U.S. Congress enacted the National Childhood Vaccine Injury Act (NCVIA) of 1986. One of the provisions of the act stated,
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.
When Hanna Bruesewitz was one year old, her pediatrician administered doses of DTP vaccine that was manufactured by Lederle Laboratories (later purchased by Wyeth LLC). Hanna immediately started to experience seizures and has suffered seizures since being vaccinated. Hanna's parents filed a lawsuit against Lederle, alleging that the company was liable for strict liability and negligent design of the vaccine. The U.S. District Court granted Wyeth summary judgment, holding that Bruesewitz's causes of action was preempted by the NCVIA. The U.S. Court of Appeals affirmed the judgment. Bruesewitz appealed to the U.S. Supreme Court. Bruesewitz v. Wyeth LLC, 131 S.Ct. 1068, 2011 U.S. Lexis 1085 (Supreme Court of the United States, 2011)
1. What does the Supremacy Clause provide?
2. Is it ethical for vaccine manufacturers to be absolved from liability by federal law? What is the public policy underlying the federal law?
3. Does the preemption provision in the federal NCVIA bar state law design-defect product liability claims against vaccine manufacturers?