It’s Only Logical: This Bill Will End the Era of Vaccine Liability Protection

End the Vaccine Carveout Act, Congressman Paul Gosar (AZ-09). We have waited too long for this bill.

In 1986, the U.S. Congress passed the National Childhood Vaccine Injury Act (NCVIA), establishing a legal shield for vaccine manufacturers from lawsuits related to vaccine-related injuries. At the same time, the National Vaccine Injury Compensation Program (NVICP) was created as an alternative to traditional litigation, providing a "no-fault" system for compensating individuals injured by vaccines. The intention was to balance the need to protect vaccine manufacturers from crippling lawsuits while ensuring victims had a straightforward path to compensation. However, the NVICP has failed to deliver on its promise of a non-adversarial, fair, and efficient process, leaving many families in limbo.

With the introduction of H.R. 9828, the End the Vaccine Carveout Act, Congressman Paul Gosar (AZ-09) seeks to correct this decades-old imbalance by removing the immunity provisions that shield pharmaceutical companies from liability for vaccine injuries. This bill represents a turning point in the public health landscape, ushering in a long-overdue conversation about accountability and safety. It’s only logical: liability is a fundamental mechanism for ensuring product quality and consumer safety in any industry, and vaccines should be no exception.

The National Vaccine Injury Compensation Program: A Broken Promise

The NVICP was initially established to assure parents that a fast, fair, and non-adversarial process would be available to compensate for vaccine injuries. However, the reality has been far different. The program has become mired in complexity, requiring individuals to prove causality for their injuries in individual cases, despite well-documented evidence that certain vaccines cause predictable injuries.

For instance, claimants are required to prove causality from scratch for each case, yet special masters frequently cite precedent from prior cases, creating an inconsistent and adversarial process. This paradox not only undermines the original promise of the NVICP but also creates significant legal hurdles for families seeking justice and support for their vaccine injured loved ones.

One particularly high-profile case that revealed the system’s flaws was the Autism Omnibus proceedings, in which thousands of families claimed that vaccines led to their children's autism. Hannah Poling’s case emerged as a landmark: she developed encephalopathy and regressed into autism after receiving vaccines, and causality was acknowledged. However, the government removed her case from the broader proceedings, quietly settling it while denying compensation to other families facing similar situations. The rest of the Autism Omnibus cases were dismissed, leaving many families feeling that the system was stacked against them.

Decades of Delay: The Case of Guillain-Barré Syndrome

Another example of the NVICP’s failure is its delay in recognizing vaccine-related injuries. In 1976, reports began to surface that Guillain-Barré Syndrome (GBS), a rare autoimmune disorder that attacks the nervous system, was linked to the swine flu vaccine. Despite decades of well-documented cases, it took more than 30 years for GBS to be included on the vaccine injury table—a list of injuries presumed to be caused by vaccines, simplifying the compensation process.

This extended delay highlights a broader issue: the NVICP, designed to expedite compensation for known injuries, has often been slow and ineffective and is seen by many as a weapon used to deny vaccine injury and death. Instead of proactively adding well-documented injuries to the table, families are forced to endure lengthy legal battles to prove causality anew, even for injuries long associated with vaccines.

The Profits of Big Pharma: Protected and Profitable

Since the passage of the NCVIA, vaccine manufacturers have enjoyed enormous financial rewards while being shielded from liability. This is especially true in the wake of the COVID-19 pandemic, where companies like Pfizer and Moderna generated unprecedented profits from their vaccines. In 2021 alone, COVID-19 vaccine sales brought in nearly $100 billion globally, an astronomical sum for an industry that faces little risk of litigation for its products.

The lack of liability for vaccine manufacturers has undermined one of the most effective mechanisms for ensuring product safety: the risk of legal action. In virtually every other industry, liability is a form of quality control. Car manufacturers, food producers, and medical device companies are all held accountable for the safety of their products through litigation. Companies are held responsible if a product causes harm, incentivizing them to improve safety standards. Without this safeguard, vaccine manufacturers have little incentive to ensure their products are as safe as possible.

H.R. 9828: Restoring Accountability

H.R. 9828, the End the Vaccine Carveout Act, aims to end the special legal immunity granted to vaccine manufacturers under the 1986 NCVIA. Introduced by Congressman Paul Gosar with 30 cosponsors, the bill seeks to restore the right of individuals injured by vaccines to pursue civil lawsuits in state or federal court. In doing so, the legislation would hold vaccine manufacturers accountable for the safety of their products, just as every other industry is held responsible for theirs.

The bill also addresses conflicts of interest in the vaccine approval process. As Gosar noted, many government scientists responsible for approving vaccines hold patents for those same vaccines, creating an incentive for biased decision-making. The End the Vaccine Carveout Act would end these conflicts, ensuring that decisions about vaccine safety and efficacy are made in the public’s best interest, not the interests of profit.

By reinstating liability, H.R. 9828 restores a critical layer of accountability to the vaccine industry. As Robert F. Kennedy Jr., founder of Children’s Health Defense, has argued, the liability shield removed any incentive for vaccine manufacturers to prioritize safety. Restoring the ability to sue for damages will force vaccine makers to reevaluate their safety protocols and invest in developing safer products.

Liability as Quality Control

Liability is more than a punitive measure—it is a form of quality control that ensures companies have a vested interest in the safety of their products. In industries like automobiles and consumer electronics, companies constantly improve the safety and reliability of their products to avoid costly lawsuits. Vaccine manufacturers, uniquely insulated from this pressure, have little incentive to innovate on safety.

By removing liability protection, H.R. 9828 would create the same market forces that drive safety improvements in other sectors. Manufacturers would be incentivized to rigorously test their vaccines, conduct long-term safety studies, and to transparently communicate potential risks to the public. It’s only logical: the threat of liability would compel vaccine makers to prioritize safety.

The Time for Change

For decades, vaccine manufacturers have operated with unprecedented legal immunity, enjoying massive profits while those injured by their products face an uphill battle to secure justice. The NVICP, once hailed as a solution to the crisis of vaccine injury litigation, has failed to live up to its promise of a fair and efficient compensation system.

With H.R. 9828, the public restores accountability to the vaccine industry and end the era of special legal protections for Big Pharma. Liability is not just a mechanism for punishment—it’s a tool for ensuring product safety. By holding vaccine manufacturers accountable, we can encourage the development of safer vaccines and restore public trust in the vaccination process.

The time has come to end the liability shield for vaccine manufacturers. The End the Vaccine Carveout Act is a logical step toward restoring accountability, justice, and safety in public health. It’s only logical that we demand and expect the same level of safety and responsibility from vaccine makers as we do from every other industry.

Let your legislators know you want them to support the end of the free-for-all:

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Cited Bill: H.R. 9828 - End the Vaccine Carveout Act

The bill H.R. 9828, introduced by Congressman Paul Gosar on September 26, 2024, seeks to remove liability protections for vaccine manufacturers under the National Childhood Vaccine Injury Act. The bill would restore the right of individuals injured by vaccines to sue manufacturers in state or federal courts, repealing the sections of the NCVIA that currently provide immunity. By reinstating liability, the legislation aims to ensure that vaccine manufacturers prioritize safety and accountability.

PRESS RELEASE:

Washington, D.C.  -- Congressman Paul A. Gosar, D.D.S. (AZ-09), issued the following statement after introducing H.R. 9828, the End the Vaccine Carveout Act, a bill that would strip vaccine manufacturers of their unjust liability shields. This carveout has resulted in hundreds of billions of dollars in profits for Big Pharma while leaving tens of thousands of people without the ability to seek legal justice and compensation for injuries caused by vaccines. 

“Although federal bureaucrats and Big Pharma insist that vaccines are safe, there is an unfortunate lack of science regarding the safety of vaccines.  For example, a review of 12,000 scientific papers by the Institute of Medicine published in 2012 found that 98% of injuries studied were either caused by or may have been caused by a vaccine.  Another government study found that while vaccines caused injuries in 10 percent of cases, only one percent get reported, meaning those injured by vaccines are vastly undercounted.

Furthermore, according to the Center for Disease Control’s Vaccine Adverse Event Reporting System, nearly 20,000 Americans were reported as having been killed to date by a COVID-19 vaccine, equating to one death for every 14,000 people vaccinated, much higher than the one in a million deaths that is normally cited for dangerous vaccines.

Government bureaucrats and scientists responsible for approving vaccines are in bed with Big Pharma, often owning pharmaceutical stocks, serving as consultants and receiving lucrative contracts from pharmaceutical companies that pressure them to produce favorable results which is in direct violation of federal law.

Worse, many scientists and researchers in government agencies develop patents for vaccines that are approved by the very agencies they work for, creating a conflict of interest and raising serious questions about the impartiality of their decisions.

Under current law, it is nearly impossible to hold vaccine manufacturers liable for injuries caused by vaccines due to a 1986 law that unfairly created a special immunity carveout for Big Pharma, making it very difficult for vaccine-injured victims to win in a court of law. 

My legislation strips away current immunity provisions unfairly shielding Big Pharma from the harms caused by their products and allows those injured by vaccines to pursue a civil lawsuit in state or federal court.  Big Pharma doesn’t deserve a get-out-of-jail-free card for injuries caused by their harmful vaccines,” concluded Congressman Gosar.

Children’s Health Defense Founder and Chairman of the Board on Leave Robert F. Kennedy Jr, said: “The four American vaccine makers are criminal enterprises that have paid tens of billions in criminal penalties over the past decade.  By freeing them from liability for negligence, the 1986 statute removed any incentive for these companies to make safe products.  If we want safe and effective vaccines, we need to end the liability shield.”

Children’s Health Defense President Mary Holland added: “Thank you to Congressman Gosar for introducing this historic and urgently needed legislation.  For over 35 years, parents of children injured and killed by government-recommended vaccines have been left with no meaningful redress -- only a complex, sham compensation program that pits grieving families against the government, while Big Pharma enjoys no liability. During that same time, chronic health conditions in children - autism, ADHD, severe allergies, asthma - have skyrocketed. This legislation will help to end Big Pharma’s reign over government. The corrupt public-private partnership of the 1986 National Childhood Vaccine Injury Act has suppressed science, stacked the deck against families, subverted the democratic marketplace of checks and balances, and removed citizens’ rights to a trial by jury. Americans deserve better.”

Background:

In 1986, Congress passed the National Childhood Vaccine Injury Act (NVCIA), which shields vaccine manufacturers from the harm caused by their products, making it almost impossible for a person injured by a vaccine to win in court.  The plaintiff must prove that the vaccine manufacturer deliberately “[withheld] information relating to the safety or efficacy of the vaccine,” engaged in “criminal or illegal activity relating to the safety and effectiveness of vaccines,” or “by clear and convincing evidence… failed to exercise due care.” Satisfying these requirements is practically an impossibility.   

The Centers for Disease Control (CDC) and the National Institutes of Health (NIH) are tasked with approving vaccines.  Sadly, there exists a massive conflict of interest, since the scientists who work at these agencies license the patents to vaccine manufacturers and, in so doing, earn up to $150,000 in royalties. Furthermore, voting members on the boards that advise the CDC and the NIH owned stocks in vaccine manufacturers, engaged in contract work for vaccine manufacturers, and received grants from vaccine manufacturers.