Health Care Policy “Experts” Back Strong Liability Protections for Vaccine Manufacturers

In a survey of health policy conducted and published in Health Policy by the Cornell University Health Policy Center, a majority of 62 “health care policy experts” participating in an “Insight Panel” said they believe that weakening liability protections for drug manufacturers would substantially reduce pharmaceutical innovation and increase prices for existing vaccines. Several of the panel participants surveyed stated they also believe that making pharmaceutical companies more liable for vaccine injuries and deaths in a civil court of law could lead some manufacturers to stop investing in research and development of new vaccines, and about half said increased liability could impact the willingness of physicians to administer vaccines to patients. Since doctors administering vaccines don’t want to be vulnerable to medical malpractice lawsuits, some suggested doctors may become less willing to administer or promote use of vaccines if there is more liability for vaccine manufacturers.¹

Several of the health care policy experts panelists surveyed referenced a 2004 paper published in the Quarterly Journal of Economics, which concluded that policies that promoted and incentivized vaccination and reduced legal liability for vaccine injuries and deaths led to an increase in the number of clinical trials for new vaccines and facilitated research and development of new vaccines.¹

Evidence for this is reflected in the expansion of the federally recommended childhood vaccine schedule over the past four decades. In 1983, the U.S. Centers for Disease Control and Prevention (CDC) recommended 23 doses of seven vaccines—live polio vaccine (OPV); diphtheria-pertussis-tetanus (DPT); and measles-mumps-rubella (MMR)—which were administered between two months and six years old.  By 2023, the schedule had expanded to 72 doses of 17 vaccines given between the day of birth and age 18.^{2 3}

1982 TV Documentary, Parents of DPT Vaccine Injured Children Prompted Threats and Disinformation from Vaccine Manufacturers

In the spring of 1982, after the national broadcast of the Emmy award winning television documentary “DPT: Vaccine Roulette”⁴  the charity Dissatisfied Parents Together (DPT) was founded in the Washington, DC area by parents of DPT vaccine injured children, who began lobbying for a less reactive acellular pertussis vaccine.⁵ The response by manufacturers of DPT vaccine (Wyeth, Lederle, Connaught) was to threaten to leave the country with no childhood vaccines unless Congress gave them total liability protection from vaccine injury lawsuits.

This blackmail by the pharmaceutical industry was based on a false narrative that vaccine injury lawsuits were driving vaccine manufacturers out of business when, in truth, there were only a few high profile multi-million dollar jury awards for plaintiffs and the majority of court cases were settled on the courthouse steps after wealthy drug companies and their attorneys dragged out court cases so that exhausted, cash poor parents caring for vaccine injured children would settle for low sums of money. Then, DPT vaccine manufacturers claimed there were pertussis vaccine shortages and the need for DPT price increases because of financial losses from vaccine injury lawsuits—even though evidence presented in congressional testimony proved that to be completely untrue.^{6 7} That false narrative continues to be often repeated today.⁸

Congressional Hearings and 1986 National Childhood Vaccine Injury Act

After the broadcast of “DPT: Vaccine Roulette” and threats from vaccine manufacturers, congressional staff members informed parents of DPT vaccine injured children that Congress was going to protect the childhood vaccine supply with federal legislation. There were a series of congressional hearings held between 1982 and the end of 1986, during which time the National Childhood Vaccine Injury Act was created by a bi-partisan group of congressional staff members and “vaccine stakeholders,” that included parents of DPT vaccine injured children, American Academy of Pediatrics (AAP) leaders, federal health officials, and vaccine manufacturer representatives.⁹

The 1986 Act,¹⁰ which was signed into law by President Ronald Reagan in November 1986, was historic acknowledgement by the U.S. government that federally licensed and recommended childhood vaccines mandated by states for children to attend school can injure and kill; that vaccine safety should be made a national priority; that vaccine injured children should be provided with a non-adversarial, expedited and more just administrative federal Vaccine Injury Compensation Program (VICP) alternative to suing a drug company, and that doctors negligently administering vaccines should continue to be liable in civil court for medical malpractice and drug companies should continue to be liable for product design defect in the manufacture of vaccines.

Reagan Reluctantly Signs Act After Parents Secured Vaccine Safety Provisions and Protected Lawsuits Against Vaccine Makers and Administrators

The parent co-founders of Dissatisfied Parents Together, which in 1989 became the National Vaccine Information Center (NVIC), were responsible for securing vaccine safety informing, recording, reporting and research provisions in the law and for ensuring it did not shield doctors administering vaccines from medical malpractice lawsuits and that parents could continue to sue vaccine manufacturers for product design defect when there was evidence a company could have made a vaccine less reactive. After President Reagan reluctantly signed the Act into law in 1986 over the objections of the Department of Justice because it did not eliminate all product liability for vaccine manufacturers or medical malpractice liability for vaccine administrators,¹¹ in 1987, Congress quietly added an amendment to the law eliminating medical malpractice lawsuits against negligent vaccine administrators.¹²

Then, starting in the early 1990s and over the next three decades, additional congressional amendments and rule making by the Department of Health and Human Services severely weakened vaccine safety and vaccine injury compensation provisions.^{13 14} In 2011, the U.S. Supreme Court majority ruled in Bruesewitz v. Wyeth that childhood vaccines are “unavoidably unsafe” and effectively removed all liability for vaccine injuries and deaths from vaccine manufacturers.¹⁵

Often referred to as the “Vaccine Court,” the administrative federal Vaccine Injury Compensation Program (VICP) requires vaccine injured individuals or the families of those who have died after vaccines, which are recommended by the federal government for children, to sue the Secretary of Health, who is represented by Department of Justice (DOJ) attorneys in Vaccine Court. The vaccine injured are represented by privately retained plaintiff attorneys, with contested cases being argued in the U.S. Court of Federal Claims in Washington, DC.

Money to fund federal compensation awards comes from a 0.75 cent tax applied by vaccine manufacturers to every dose of a covered vaccine and that money is held in a Trust Fund managed by the U.S. Treasury. COVID-19 vaccine injury claims are handled through a separate Countermeasures Injury Compensation Program (CICP). Created by Congress in 2005, the COVID-19 biological was added to the CICP in March 2020.¹⁶

How the VICP Works

As the system currently operates, when a person has experienced a vaccine-related injury, a claim can be filed with evidence, such as medical records and other documentation, which is reviewed by officials at the U.S. Department of Health and Human Services (DHHS). If federal health officials believe the vaccine(s) caused the injury or death, and the injury is included on the Vaccine Injury Table in the Act and qualifies for automatic administrative compensation, an uncontested award is made to the claimant. However, if the vaccine injury claim is contested by Department of Health officials as not being related to the vaccine(s) given, plaintiff’s attorneys and DOJ attorneys will present evidence, including expert witness testimony, to a special master in the U.S. Court of Federal Claims in Washington, DC, who will make a ruling about whether or not the claimant receives an award.¹⁷

The list of injuries to receive automatic compensation can be found here. Since its establishment, the VICP has paid out $5 billion to around 13,000 claimants.¹⁸

Founders of DPT/NVIC Have Publicly Criticized the Destruction of the 1986 Act and VICP for Four Decades

The 1986 Act was a law that was designed to elevate vaccine safety to a national priority and provide “simple justice for children,” especially for vaccine injured children whose parents do not have the financial resources to sue vaccine manufacturers or negligent doctors in civil court.  In congressional testimony, legal actions, and public comments for federal vaccine advisory committees, U.S. health agencies and the media, the founders of Dissatisfied Parents Together (DPT)/National Vaccine Information Center (NVIC) have protested the destruction of vaccine safety and compensation provisions in the National Childhood Vaccine Injury Act of 1986.^{19 20 21 22}

The Congress, Departments of Health and Human Services and Justice, and the U.S. Supreme Court together participated in the ruination of the Act, including the Vaccine Injury Compensation Program administrative alternative to a lawsuit. If the Act had been allowed to function as it was when it became law in 1986, parents would be provided with complete and truthful information about vaccine and disease risks before their children are vaccinated; doctors would be required to obey the Act’s requirement to report reactions, injuries and deaths that occur after vaccination to the federal Vaccine Adverse Event Reporting System (VAERS); DHHS would have fully complied with vaccine safety research provisions in the Act; and children required by states to receive federally recommended vaccines to attend school would be quickly and generously compensated for vaccine injuries.

Most importantly for those now suffering with injuries from the mRNA COVID-19 biological labeled a vaccine, if the US Supreme Court had not eliminated design defect liability from vaccine manufacturers, today that mRNA product would be subject to product design defect lawsuits in civil court. Even so, plaintiff’s would still face severe restrictions on product liability and medical malpractice lawsuits due to tort reforms instituted in many states over the past four decades.²³

Proposed Reforms for the VICP

Anna Kirkland, a professor of law, health, and medicine at the University of Michigan has stated it is her opinion that there are “friendly amendments with bipartisan support” needed to improve the VICP, such as hiring more special masters to hear the vaccine injury cases that have dramatically increased as more vaccines have been added to the childhood vaccine schedule by the CDC. She also suggested increasing certain compensatory damage caps set at $250,000 and changing the statute of limitations for filing claims which is currently set at three years.²⁴

In recent years, U.S. Secretary of Health and Human Services Robert. F. Kennedy, Jr. and others have criticized the VICP as being inefficient and biased in favor of the government’s position that vaccine injuries and deaths are “rare.” Secretary Kennedy has called the program “biased” against those seeking compensation, slow, complicated and unfair to victims. Some have called for total repeal of the 1986 Act, which would take an act of Congress, Kennedy has said he wants to “revolutionize” the vaccine injury compensation program.²⁴

In September 2025, Bloomberg News reported that Kennedy was considering adding more injuries to the Vaccine Injury Table, such as certain symptoms of autism, so those injuries can be recognized and compensated. Although the Secretary of Health has the authority to add, subtract or modify the list of symptoms and conditions eligible for federal vaccine injury compensation, the changes would likely be required to go through a regulatory process that would take time to complete.”²⁵

Some Question If Changes to Vaccine Schedule Will Change Liability Shields

At the beginning of this year, the Advisory Committee on Immunization Practices (ACIP) recommended and Kennedy reduced the number of federally recommended childhood vaccines to more closely match the childhood vaccine schedule of Denmark and other European countries. Some have alleged that this could open the door to removing liability protection for non-federally recommended vaccines for children.

“Some legal experts aren’t so sure that there’s an immediate opening to strip away liability shields but see the changes by Kennedy and his aides as a step in that direction, making it easier to sue vaccine manufacturers over injuries believed to be caused by the shots,” reported Stat News. HHS maintains that the changes in the schedule do not affect liability protections but vaccine manufacturing industry leaders are expressing concern about losing liability protections for some vaccines recommended for children (which are also given to adults, including pregnant women) and do not want long standing national vaccine policies to change.”²⁶

Authors of the article in Health Affairs, which reported on the Cornell University Health Policy Center findings, write:

Although there are few details regarding specific proposed reforms, changes to the program could include removing certain vaccines from protection; allowing more litigation outside of the VICP; adding more conditions to the list eligible for compensation, including those without an established link to vaccines; and making the vaccine manufacturer, instead of the federal government, the defendant in vaccine-injury cases.¹

Congress has the authority to repeal damaging amendments and rulemaking made to the historic 1986 Act so it returns to its original form when it became law in November 1986. This action would not only truly make vaccine safety and meaningful scientific research a national priority but would provide a fully functioning non-adversarial federal compensation system alternative to filing a lawsuit. At the same time, negligent doctors and other vaccine administrators would be liable for medical malpractice and pharmaceutical corporations would be liable for product design defect in the manufacture of vaccines.²⁷

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