The 1986 National Childhood Vaccine Injury Act created by members of Congress after more than four years of deliberation with vaccine stakeholders, including parents of vaccine injured children, medical trade associations, public health agencies, vaccine manufacturers, and Administration officials, was signed into law as part of an Omnibus health bill by President Ronald Reagan on Nov. 14, 1986. The Act’s provisions specifically applied to federally licensed and recommended vaccines for children routinely mandated by states for school attendance.
1986 National Childhood Vaccine Injury Act (with subsequent amendments attached after the law was passed by Congress).
During the early 1980s when the Act was being developed, there were seven childhood vaccines federally recommended and required by states for school attendance: diphtheria, tetanus, pertussis (DPT); oral polio vaccine (OPV); and measles, mumps and rubella (MMR). The majority of the vaccine injury lawsuits were for brain damage caused by the inactivated whole cell pertussis vaccine in injectable DPT shots and for vaccine strain polio paralysis caused by the live oral polio vaccine.
In April 1982, the Emmy award winning NBC-TV documentary DPT: Vaccine Roulette produced by investigative journalist Lea Thompson was broadcast.
That month, the non-profit Dissatisfied Parents Together (DPT) organization was founded by parents of DPT vaccine injured children in the Washington, DC area, a charity that would establish the National Vaccine Information Center in the late 1980s.
Donna Hilts. TV Report on Vaccine Stirs Bitter Controversy. Washington Post Apr. 28, 1982.
Co-founders of DPT/NVIC worked with Congress on federal legislation that would (1) include vaccine safety informing, reporting, recording and research protections; (2) protect a parent’s right to sue negligent drug companies and doctors in civil court for their child’s vaccine injury or death; and (3) offer parents access to a federal vaccine injury compensation program as an alternative to filing a lawsuit in civil court.
The 1986 National Childhood Vaccine Act was the first U.S. law to officially acknowledge that childhood vaccines licensed and recommended by the federal government, which are routinely mandated for school attendance by state governments, can and do injure and kill a minority of children.
The Act affirmed that (1) the prevention of vaccine injuries and deaths should be made a national priority and (2) children injured by federally recommended and state mandated vaccines should have access to a no-fault expedited, less expensive, less traumatic, and more just federal Vaccine Injury Compensation Program (VICP) administrative alternative to suing drug companies and doctors in civil court.
A major goal of co-founders of Dissatisfied Parents Together (DPT), who established the National Vaccine Information Center (NVIC) was to obtain a less toxic pertussis vaccine for babies in America.
The book DPT: A Shot in the Dark, which I co-authored with medical historian Harris Coulter, PhD, was published by Harcourt Brace Jovanovich in December 1984. It described the risks and failures of the whole cell pertussis vaccine in DPT shots and the suffering caused by inflexible implementation of childhood vaccine mandates.
Harris Schwartz. Shots or Not? New York Times Feb. 3, 1985.
Institute of Medicine. Appendix B – Pertussis and Rubella Vaccines: A Brief Chronology – 1982-1986. In: Adverse Effects of Pertussis and Rubella Vaccines. National Academy of Sciences 1991.
Dissatisfied Parents Together (DPT) sponsored a Feb. 7, 1985 press conference on Capitol Hill and led parents of DPT vaccine injured children in a march in front of the CDC in Atlanta on May 12, 1986 to publicize whole cell pertussis vaccine risks followed by a formal presentation to the CDC’s Advisory Committee on Immunization Practices.
Dissatisfied Parents Together (DPT). Vaccine Manufacturers’ Memos and New Book Show Pertussis Vaccine Not Being Tested for Safety; Parents Demand Congressional Investigation. Press Release Feb. 7, 1985.
Medical World News. DPT Vaccine Protest Gets Airing at CDC. June 9, 1986.
The advocacy by parents of vaccine injured children and passage of the 1986 Act put pressure on the U.S. public health system to license a purified, less reactive acellular pertussis vaccine (DTaP) for toddlers in 1988 and for infants in 1996 and, in 1999, to replace the live oral polio vaccine (OPV) that can cause vaccine strain polio paralysis with an inactivated polio vaccine (IPV) that cannot do that.
Clearing Up Myths About the 1986 Act with Facts
Since the Act was enacted in November 1986, myths about the intent and history of the legislation have affected public perception of it. As co-founder and Vice President of Dissatisfied Parents Together (DPT) and co-founder and President of the National Vaccine Information Center (NVIC), in November 2023 I gave an in-depth interview to broadcast journalist Del Bigtree on “Highwire,” and talked about my work with DPT co-founder and NVIC Co-founder and Vice President Kathi Williams and DPT co-founder and former President Jeffrey Schwartz, JD, during development of the federal legislation between April 1982 and November 1986, as well as what happened after the 1986 Act was passed. I backed up my statements with documents, including some publicly released for the first time.
Below is a summary of “Myths & Facts” about the 1986 Act and take-home points made in my “Highwire” interview, as well as links to copies of documents used to anchor my statements.
1. MYTH: In 1986, Congress gave pharmaceutical companies and doctors administering vaccines a total liability shield from ALL vaccine injury lawsuits in the National Childhood Vaccine Injury Act.
FACT: The vaccine manufacturers threatened to leave the nation with no childhood vaccines if they did not get a total liability shield from vaccine injury lawsuits but, from the outset of negotiations on federal vaccine safety and federal compensation legislation, the co-founders of Dissatisfied Parents Together (DPT) maintained that any legislation must protect the legal right of parents of vaccine injured children to sue negligent vaccine manufacturers and doctors in civil court.
Jeffrey Schwartz, President, Dissatisfied Parents Together (DPT). Testimony for U.S. Senate Committee on Labor and Human Resources on S.2117. Pages 46-60. May 3, 1984.
When the 1986 National Childhood Vaccine Injury Act was passed by Congress on Nov. 14, 1986, the Act DID NOT shield drug companies from all vaccine injury lawsuits or shield doctors and other vaccine administrators from medical malpractice lawsuits.
In the original Act passed by Congress, the vaccine manufacturers still could be sued for product design defect when there was evidence the company could have made a vaccine less reactive, and negligent doctors and other medical workers could still be sued we for medical malpractice for negligently administering a vaccine to a child.
The vaccine manufacturers, medical trade associations, such as the American Academy of Pediatrics and American Medical Association, federal agency officials, some lawmakers and the Reagan Administration opposed provisions in the 1986 Act that continued to hold drug companies, doctors and other vaccine administrators accountable and liable in a civil court of law for vaccine injuries and deaths. After the law was passed, they lobbied for amendments to the Act to give them a total liability shield.
- President Reagan and his Administration opposed product design defect and medical malpractice liability provisions in the 1986 Act.
President Ronald Reagan. Statement on signing the State Comprehensive Mental Health Bill, which contained the National Childhood Vaccine Injury Act. Nov. 14, 1986. Ronald Reagan Presidential Library and Museum.
Dennis E. Ross, Tax Legislative Counsel, Dept. of Treasury. Testimony on the Vaccine Injury Compensation Program for U.S. House Committee on Ways and Means Select Revenue Measures Subcommittee. Mar. 5, 1987.
- The vaccine manufacturers opposed product design defect liability provisions in the 1986 Act.
Robert B. Johnson, President Lederle Laboratories, American Cyanamid. Testimony on the Vaccine Injury Compensation Program for U.S. House Committee on Ways and Means Select Revenue Measures Subcommittee. Mar. 5, 1987.
Medical Trade Associations opposed medical malpractice liability provisions the 1986 Act. M. Roy Schwarz, MD, American Medical Association. Testimony on the Vaccine Injury Compensation Program for US House Committee on Ways and Means Select Revenue Measures Subcommittee. Mar. 5, 1987.
- Dissatisfied Parents Together (DPT) representing parents of vaccine injured children supported liability provisions in the 1986 Act that held negligent vaccine manufacturers and vaccine administrators liable in a civil court of law.
Jeffrey Schwartz, JD, President Dissatisfied Parents Together (DPT). Testimony on the Vaccine Injury Compensation Program for US House Committee on Ways and Means Select Revenue Measures Subcommittee. Mar. 5, 1987.
After the Act was passed, beginning in 1987 and throughout the 1990s, lobbyists for the pharmaceutical industry and medical trade, as well as federal officials and lawmakers, worked to eliminate civil liability for drug companies and doctors through congressional amendments and federal agency rule making.
- BETRAYAL BY CONGRESS: In 1987, without the knowledge of parents of vaccine injured children who had worked with Congress on the Act, medical trade lobbyists got an amendment attached to a federal end-of-year Omnibus budget bill that shielded negligent doctors and other vaccine administrators from medical malpractice vaccine injury lawsuits.
- BETRAYAL BY CONGRESS AND DHHS. Congressional amendments and rule making changes by the Department of Health and Human Services eliminated or severely damaged key vaccine safety and compensation provisions designed to prevent vaccine injuries and deaths and provide expedited, less traumatic and less expense, more just no-fault federal compensation to vaccine victims often denied in the civil court system.
H.R. 2202. Preventive Health Amendments of 1993. Section 708: Simplification of Vaccine Information Materials. Sponsor: Rep. Henry Waxman (D-CA).
Barbara Loe Fisher. The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform. Advisory Commission on Childhood Vaccines Nov. 18, 2008.
Barbara Loe Fisher, Kathi Williams, Theresa Wrangham. NVIC Statement for Government Accountability Office investigation into operation of the Vaccine Injury Compensation Program (VICP) July 11, 2014.
Barbara Loe Fisher, Theresa Wrangham. Public Comment to DHHS Health Resources Services Administration (HRSA) Opposing Changes to the Vaccine Injury Table. Jan. 25, 2016.
- SUPREME COURT BETRAYAL: In 2011, the majority of justices on the US Supreme Court in Bruesewitz v Wyeth (a DPT vaccine injury product design defect lawsuit) ignored the 1986 Act’s legislative history which demonstrated that Congress refused to grant industry and medical trade total liability protection for childhood vaccine injuries and deaths. Instead, the majority of justices sided with the pharmaceutical industry, medical trade associations, public health and government officials, and eliminated civil liability from vaccine manufacturers if a vaccine that caused an injury or death had been licensed as safe by the U.S. Food and Drug Administration, (FDA) - even if there was evidence the company could have made a vaccine less likely to cause harm.
Supreme Court of the United States. In Bruesewitz v. Wyeth. Petition of Amici Curiae, National Vaccine Information Center, Its Co-founders and 11 other organizations in support of petitioner. June 1, 2010.
Supreme Court of the United States. Russell Bruesewitz et al v. Wyeth et al. No. 09-152. Argued October 12, 2010 – Decided February 22, 2011. Majority opinion by Justice Scalia. DISSENT by Justice Sonia Sotomayor with Justice Ruth Bader Ginsburg joining.
2. MYTH: The 1986 Vaccine Injury Act created a federal Vaccine Injury Compensation Program (VICP) as the exclusive remedy for obtaining financial assistance after a child was injured by a federally licensed and recommended vaccine to replace vaccine injury lawsuits in civil court.
FACT: The 1986 Act created a federal Vaccine Injury Compensation Program (VICP) administrative alternative to a civil vaccine injury lawsuit, with vaccine injury claims adjudicated by the U.S. Department of Health and Human Services and the U.S. Federal Court of Claims in Washington, DC. If the vaccine injured claimant was denied compensation or the compensation offered was too little to take care of the disabled child’s lifetime needs, a vaccine injury lawsuit could be filed in civil court, including when there was evidence the vaccine manufacturer could have made the vaccine less reactive (product design defect).
Barbara Loe Fisher. The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform. Advisory Commission on Childhood Vaccines Nov. 18, 2008.
3. MYTH: Before the 1986 Act, there were many multi-million-dollar lawsuits won in jury trials against vaccine manufacturers.
FACT: There were a few multi-million-dollar jury awards against DPT and polio vaccine manufacturers, but the majority of vaccine injury lawsuits in the 1970s and 1980s were settled on the courthouse steps for low sums with court documents sealed to prevent details from vaccine injuries and deaths from being viewed by the public.
In the 1980s, the vaccine manufacturers were telling Congress they couldn’t get insurance and needed to raise childhood vaccine prices and limit vaccine production, which caused vaccine shortages, because vaccine injury lawsuits were ruining their business. However, they were telling Wall Street investors something entirely different.
Jeffrey Schwartz, President Dissatisfied Parents Together (DPT). Testimony in U.S. House Health and Environment Subcommittee on vaccine shortages. Dec. 19, 1984.
Jeffrey Schwartz, President Dissatisfied Parents Together (DPT). Testimony in U.S. House Health and Environment Subcommittee. July 25, 1986.
Dissatisfied Parents Together (DPT). Congress to Investigate 10,000 Percent Increase in DPT Vaccine Prices; DPT Group Charges Drug Companies Make $80 Million Windfall Profit. Press Release Aug. 11, 1986.
4. MYTH: The federal vaccine adverse event reporting system (VAERS) and Vaccine Information Statements published by the Centers for Disease Control (CDC) were created by federal health agencies and were not related to the 1986 Act.
FACT: The co-founders of Dissatisfied Parents Together (DPT) were responsible for securing vaccine safety informing, recording, reporting and research provisions in the 1986, which mandated that federal health officials (1) create written information about childhood vaccine benefits and risks to be given to parents of minor children before vaccination; (2) create a centralized vaccine adverse event reporting system (known today as VAERS) that would be open to the public for reporting and viewing of childhood vaccine adverse event reports; (3) require doctors and other vaccine providers to record information about vaccines administered, including the name of the vaccine; manufacturer’s name and lot number, and date vaccine was administered; (4) require vaccine manufacturers, doctors and other vaccine providers to record and report adverse events following childhood vaccinations, including hospitalizations, injuries and deaths, to the federal government; and (5) to conduct research into the safety of recommended childhood vaccines.
1986 National Childhood Vaccine Injury Act (with subsequent amendments attached after the law was passed by Congress). Establishment (related studies; study of other vaccine risks; review of warnings and precautionary information; vaccine research. Subpart C – Assuring a Safer Childhood Vaccine Program in the United States (recording and reporting of information; vaccine information; mandate for safer childhood vaccines; manufacturer record keeping and reporting).
5. MYTH: Repealing the 1986 Act would allow unrestricted lawsuits against negligent vaccine manufacturers and vaccine administrators and eliminate mandated use of toxic vaccines.
FACT: Since 1986, a number of industries, including the pharmaceutical, medical trade and insurance industries, have gone into the states and persuaded lawmakers to enact legislation granting them extensive product liability and medical malpractice liability protections from injury lawsuits. The pharmaceutical industry is the biggest and most financially and politically influential lobby on Capitol Hill and, as demonstrated by the 2011 Bruesewitz v Wyeth Supreme Court ruling, federal courts usually side with industry and government when it comes to shielding companies, federal agencies, institutions and individuals who make, license, recommend, promote, administer and mandate vaccines.
As exemplified by the recent global COVID vaccination campaign that included lockdowns, vaccine mandates and passports, the wealthy and politically powerful global mass vaccination infrastructure now includes not only the world’s largest pharmaceutical corporations and medical organizations, but also the United Nations (World Health Organization), world governments, financial institutions, philanthropic foundations, major universities and think tanks, Big Tech and global communications corporations. A report I submitted on Nov. 1, 2023 to the U.S. Judiciary Select Subcommittee on the Weaponization of the Federal Government entitled “The Silencing of Barbara Loe Fisher and the National Vaccine Information Center in the Digital Public Square: A Violation of Freedom of Thought, Speech and Conscience,” details the lengths to which those operating the U.S. and global mass vaccination infrastructure have gone and will go to protect their profit-making and the powerbase they have created to silence critics and violate fundamental civil and natural rights.
These entities will form an alliance to defeat any legislation that attempts to return full civil liability to companies marketing vaccines and to individuals who administer vaccines. They would form an alliance to further gut the 1986 Act’s historic safety provisions by eliminating public access to VAERS and prevent the securing of vaccine informing, recording, reporting, and research provisions in any new legislation attempting to replace the 1986 Act.
Over the past four decades, the government and pharmaceutical industry have demonstrated little interest in conducting research to identify individuals more vulnerable to harm from vaccines or to make vaccines and biological products less harmful, even as they take aggressive action to develop new experimental products, such as COVID shots, and force their mass use through strict implementation of one-size-fits-all public health policies and mandates.
Vaccines are pharmaceutical products that carry risks, which can be greater for some than others, and should float free in the marketplace like any other commercial product and be subject to the law of supply and demand rather than be mandated by government. Vaccines and other biological products that Americans judge to be safe, effective and necessary will be purchased and used, while those that are not will either be removed from the market by companies due to poor sales or will be replaced with less toxic and more effective products. All public health policies and laws should contain strong informed consent protections that prevent Americans from being coerced or sanctioned for exercising voluntary, informed consent to vaccination for themselves or on behalf of their minor children.
It is NVIC’s position that the 1986 National Childhood Vaccine Injury Act should return to its original form before the vaccine safety, civil liability and compensation provisions were destroyed by weakening congressional amendments, agency rule making changes, and the tragically flawed U.S. Supreme Court decision effectively removing product design defect liability from vaccine manufacturers.
Barbara Loe Fisher. Position of the National Vaccine Information Center on the 1986 National Childhood Vaccine Injury Act. National Vaccine Information Center February 2018.
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