The VICP was established as part of the National Childhood Vaccine Injury Compensation Act in 1986. In essence, this provides families with financial compensation for injury proven to be caused by a vaccine. It also protects vaccine manufacturers from lawsuits due to injuries caused by childhood vaccines, as long as every step in the manufacturing process was executed in the manner best known at the time.
The case in which the U.S. Supreme Court ruled was Bruesewitz v. Wyeth, Inc. (No. 09-152, S. Ct.). The Bruesewitz family’s daughter suffered from seizures and has permanent developmental delay, after receiving a third DTP vaccine when she was 6 months old. After losing their case in “vaccine court” (under the VICP), the Bruesewitz family sued Wyeth siting a 1998 DTP vaccine design flaw. They claimed that Wyeth had prior knowledge about the design flaw, but decided to place it on the market regardless. The Bruesewitz family filed a lawsuit against Wyeth directly with the claim that design-flaw was not protected by the VICP. Of note, 65 other children were injured by the vaccine in the same vaccine lot that their daughter received. Subsequently, the lot was pulled from the market.
In a 6-2 ruling yesterday, the U.S. Supreme Court upheld a ruling by the Third Circuit Court. Justice Antonin Scalia wrote, “Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable. State law design-defect claims are therefore preempted.” In other words, the Supreme Court decided that the VICP is still the only way in which families can receive compensation for any vaccine injury their child may experience; they cannot sue the vaccine manufacturer directly.
It is important to note that this ruling does not make claims that vaccines do not ever cause harm. It merely offers protection so that lawsuits will not bankrupt the vaccine manufacturers causing them to pull out of the market. If a withdrawal from the vaccine market would occur, it would be considered a public health issue with devastating consequences.
For example, prior to the existence of the Haemophilus influenza (Hib) type b vaccine in 1987, approximately 20,000 U.S. children became infected with Hib meningitis, pneumonia, epiglottitis, or other invasive Hib disease. Approximately 1,000 U.S. children died per year as a result of invasive Hib disease. Per the Centers for disease Control (CDC), “the incidence of Hib disease in infants and young children has decreased by 99% to fewer than 1 case per 100,000 children under 5 years of age. In the United States, Hib disease occurs primarily in underimmunized children and among infants too young to have completed the primary immunization series.”
Of note, here are a few excellent sources regarding vaccine information: