During the 1970s, several vaccine manufacturers withdrew from the vaccine market due to financial and legal concerns. On the financial side, vaccines have never been a big money maker for a pharmaceutical company. The profit margin on vaccines has never approached that of certain categories of drugs, such as cholesterol-lowering medication. On the legal side, many companies were sued by parents who felt that a particular vaccine caused a particular injury to their child. Sometimes the medical explanations provided by the parents and their lawyers were at odds with the data from studies. After a court awarded a million-dollar judgment against a pharmaceutical company, the final vaccine manufacturers were poised to leave the market.
In 1986, President Reagan signed the National Childhood Vaccine Injury Act, which created the VICP. One goal of the VICP was to provide an alternative mechanism to the civil court system for evaluating whether or not a given injury was related to the administration of a given vaccine. If evidence was found, then the family would be compensated for the injury using funds collected by charging a tax on each vaccine sold. In essence, the VICP is a nofault alternative for vaccine injuries.
One provision of this law is that families almost always have to file a claim with the VICP before they can sue a pharmaceutical company in civil court. This effectively sets up a large barrier to civil lawsuits because the parents need to go through the VICP process before they can sue the vaccine manufacturer. This provision is meant to discourage frivolous lawsuits while at the same time compensating families much more quickly if the injury is vaccine related.
The VICP has a table of severe injuries that are always presumed due to a vaccine and thus will always be compensated. Those injuries include an immediate life-threatening reaction to a vaccine (anaphylaxis), encephalopathy after an MMR or pertussis-containing vaccine, and vaccine-associated paralytic polio from the oral polio vaccine (which is no longer used in the United States).
In 2001, the VICP began receiving requests for compensation from parents based on claims that the MMR vaccine specifically, or the thimerosal in vaccines in general, contributed to the development of autism in their children. By 2008, the VICP had received over five thousand claims of this type.
After much discussion, the VICP decided to allow some test cases to move forward to special hearings to decide if the claims had merit. In 2007 and 2008, those hearings began, and the findings of those hearings are expected in 2008 or 2009. See page 84 for more information. Of note, the case of Hannah Poling, was one of those test cases. It was later settled, and the claim was withdrawn when the VICP agreed that the vaccines could plausibly be linked to her underlying mitochondrial disorder.