The National Childhood Vaccine Injury Act (NCVIA) of 1986 was passed in response to growing concerns about vaccine safety and lawsuits related to vaccine injuries. It aimed to strike a balance between protecting the vaccine supply, ensuring public health, and addressing the needs of those injured by vaccines. Here are the key things it did:
- Established the Vaccine Injury Compensation Program (VICP): The Act created a no-fault compensation program to provide compensation to individuals or families of individuals who are injured by vaccines. The goal was to ensure compensation without the need for lengthy and costly legal battles.
- Limited Lawsuits Against Vaccine Manufacturers and Administrators: The Act provided liability protection to vaccine manufacturers and administrators to reduce the threat of lawsuits that could make vaccines unavailable. It limited the ability to sue manufacturers and healthcare providers for vaccine-related injuries, but it still allowed lawsuits in cases of manufacturing defects or negligence.
- Created Vaccine Adverse Event Reporting System (VAERS): The Act mandated the creation of VAERS, a system for reporting adverse reactions to vaccines. This system allowed healthcare providers and the public to report side effects, creating a database for monitoring vaccine safety.
- Strengthened Vaccine Safety Oversight: It set requirements for the Department of Health and Human Services (HHS) to promote vaccine safety through research and development, including the creation of the National Vaccine Program and National Vaccine Advisory Committee (NVAC) to monitor and coordinate vaccine-related activities.
- Informed Consent and Record Keeping: The Act required healthcare providers to provide vaccine recipients with information about the benefits and risks of vaccines before administration. It also established guidelines for keeping detailed records of vaccinations, including lot numbers and dates, to help with injury claims if necessary.
Overall, the 1986 Act aimed to stabilize the vaccine market while ensuring that individuals injured by vaccines had a way to seek compensation.
Betrayal by Congress
After the Act was passed, starting in 1987 and continuing through the 1990s, pharmaceutical industry lobbyists, medical groups, and government officials pushed for changes to remove legal responsibility for drug companies and doctors. They did this through amendments in Congress and new rules by federal agencies.
In 1987, without informing the parents of vaccine-injured children who had helped create the Act, medical lobbyists slipped an amendment into a year-end budget bill that protected negligent doctors and vaccine administrators from being sued for vaccine injuries.
Betrayal by the Supreme Court
The 2011 Supreme Court decision in Bruesewitz v. Wyeth significantly contributed to the betrayal of the original intent of the 1986 National Childhood Vaccine Injury Act.
In this case, the Supreme Court ruled that vaccine manufacturers could not be sued in state courts for design defects in their vaccines. The ruling reinforced the protections granted to pharmaceutical companies under the 1986 Act, essentially removing their liability for claims involving the design of vaccines, even if a vaccine was alleged to have caused harm.
This decision further limited the legal options for individuals seeking compensation for vaccine-related injuries outside of the federal Vaccine Injury Compensation Program (VICP). Critics argue that this ruling solidified the shield that protects vaccine manufacturers from lawsuits, tipping the balance further in favor of industry interests over the rights of individuals affected by vaccine injuries.