The 1986 Legal Framework of Liability Shields
Vaccine manufacturers in the United States have enjoyed significant liability protections since the passage of the National Childhood Vaccine Injury Act (NCVIA) in 1986. This law was enacted to address a crisis in the 1980s where rising lawsuits against vaccine makers, particularly for the diphtheria-pertussis-tetanus (DPT) vaccine, led to manufacturers exiting the market due to high litigation costs and difficulty obtaining insurance. By 1985, only three companies remained producing the DPT vaccine in the U.S and they threatened to cease production. Congress responded by granting manufacturers near-total civil liability protection for unavoidable side effects of properly prepared and labeled vaccines.
The NCVIA created the National Vaccine Injury Compensation Program (NVICP), a no-fault federal system funded by an excise tax on vaccines, where individuals claiming vaccine injuries file petitions for compensation through the U.S. Court of Federal Claims rather than suing manufacturers directly in civil court. This means NVICP handles claims against the government rather than manufacturers and petitioners face a highly adversarial process with no jury, no full discovery, and government attorneys opposing them before Special Masters – who are government employees. Only a tiny fraction of claims from vaccine damaged have been compensated through the NVICP. It has been widely criticized as it dismisses the majority of claims, imposes impossible evidentiary burdens, and caps compensation.
The Overlooked Safety Mandate
As part of the 1986 Act, to counterpart the sweeping liability protection granted manufacturers, Congress included a clear statutory obligation on the federal government to actively pursue safer vaccines. Ensuring proactive safety improvements was the explicit provision for the extraordinary liability shielding of manufacturers. The Task Force on Safer Childhood Vaccines was created specifically under the NCVIA “Mandate for safer childhood vaccines”. HHS was to be responsible for driving ongoing safety improvements through proactive federal action.
HHS largely ignored this mandate for decades. The promised government-led safety advancements or development of lower-risk alternatives never followed. The Task Force on Safer Childhood Vaccines was effectively disbanded around 1998.
With manufacturers shielded from most lawsuits, normal market pressures for product safety was removed. As a result an extremely lucrative market was created and the recommended childhood vaccine schedule exploded from roughly 11 doses for 7 diseases in 1986 to over 70 doses for 17 diseases by 2025.
In the 2011 there was a judicial reinforcement with the Bruesewitz v. Wyeth decision. The U.S. Supreme Court ruled that the NCVIA completely bars design-defect claims for “unavoidably unsafe” vaccines, cementing the broad liability shield and leaving injured parties with almost no realistic path to hold manufacturers accountable in civil court.
Additionally the 2005 PREP Act added emergency protections which grants near-absolute immunity to manufacturers and providers of “countermeasures,” including COVID-19 vaccines, during declared public health emergencies – an immunity that has been repeatedly extended even after the declared emergency ended.
Federal Legislative Reform Proposals (2025–2026)
Multiple bills in the 119th Congress now seek to dismantle these long-standing liability shields and restore the right to sue vaccine manufacturers directly for injuries and deaths caused by their products.
S.3853 was introduced February 11, 2026 by senator Rand Paul (R-KY) and cosponsored by senator Mike Lee (R-UT). The bill repeals the NCVIA’s core liability shield, allowing injured individuals to file civil lawsuits against manufacturers in state or federal court without being forced first into the NVICP. The NVICP would no longer be a mandatory gateway, but an optional path. The bill also strips PREP Act immunity specifically for COVID-19 vaccines by removing them from the definition of “covered countermeasures.”
H.R.4668 , “End the Vaccine Carveout Act”, was introduced July 23, 2025 by Rep. Paul Gosar, with 29 Republican cosponsors. The bill is similar to S.3853, removes the mandatory NVICP filing requirement before civil action, eliminates the statute of limitations for NVICP claims, and ends PREP Act protection for COVID-19 vaccines. Sponsors state clearly that no product should receive special immunity simply because it is labeled a vaccine. A coalition of over 40 organizations and advocates has backed the End the Vaccine Carveout Act, including Children’s Health Defense, Brownstone Institute, MAHA Action, Moms Across America, Health Freedom Defense Fund, and others. It gained 28 House cosponsors within two days of reintroduction. Polling shows 61–83% voter opposition to the liability shield across Republicans, Democrats, and Independents.
H.R.1432, “LIABLE Act”, was introduced on February 18, 2025, by Rep. Chip Roy. It proposed to prohibit any federal law from granting immunity or liability limitations specifically for COVID-19 vaccine manufacturers.
State-Level Challenges to Federal Immunity
States are attempting to create pathways around federal preemption. They can not repeal federal law outright, but try to create ways for people injured by vaccines to sue manufacturers despite the 1986 NCVIA and related acts. They reflect growing state-level frustration with the federal shield and a desire to provide injured people with more direct paths to compensation or accountability.
Florida (Senate Bill (SB) 408 / House Bill (HB) 339): These companion bills, introduced in 2026, establish liability for manufacturers if the vaccine is advertised in Florida through TV, radio, in print, digitally, through social media, paid influencers or product placement. They provide a cause of action in state court with actual damages, court costs, and one-way attorney fees for prevailing claimants, while exempting normal doctor-patient discussions or materials. Effective date proposed as October 1, 2026 (if passed) and at the moment both bills advanced through initial committees and are moving to additional committees.
Iowa (HF 2287) was introduced by Rep. Charley Thomson (R). It directly targets the federal immunity under the NCVIA (specifically the design-defect protections). The bill says: No vaccine can be distributed, sold, or administered in Iowa unless the manufacturer explicitly waives (gives up) its federal immunity from lawsuits for design defects (including the broad shield from the 1986 Act). If a manufacturer distributes/sells/administers a vaccine in Iowa without signing such a waiver, the law automatically deems they have waived that immunity anyway. Manufacturers would have a waiver-or-no-sale choice.
Arkansas tried with a 2024 bill (SB 6 in the 2025 session) to create a new state criminal offense called “vaccine harm.” It would have applied to executive officers of pharmaceutical companies if they knowingly misled the public about vaccine safety/efficacy and caused harm. The bill died in Senate committee at sine die adjournment. It is an example of a state attempt to impose criminal, not just civil, penalties on manufacturers for deceptive practices leading to injury. It did not succeed due to opposition, not the least from massive pharmaceutical industry pressure.
Administrative Shifts
In an attempt to finally enforce the statutory requirement that had been neglected HHS Secretary Robert F. Kennedy Jr. reinstated the long-dormant Task Force on Safer Childhood Vaccines in August, 2025. The revived Task Force, led by NIH, FDA, CDC and other agencies, is to fulfill its core obligations, directed to collaborate with existing advisory bodies, focus on developing, promoting, and refining childhood vaccines to produce fewer and less serious adverse reactions; improving vaccine safety research, adverse reaction reporting, and oversight. First formal report to Congress is due by August 2027.
Consequences
Removing the liability shield would mean market accountability. It would force manufacturers to face the same legal consequences as any other product manufacturer when their products cause harm, creating real, and very powerful incentives, to produce safer vaccines.
Direct civil lawsuits would provide access to justice for the vaccine-damaged and be a possibility for injured to attain real compensation.
Current shields are argued to violate Constitutional Rights; the Seventh Amendment right to a trial by jury.
Arguments Against Reform
Pharmaceutical companies and their allies claim that ending liability protections would recreate the 1980s crisis, driving manufacturers out of the market and causing widespread vaccine shortages. They also threaten that a loss of immunity would lead to dramatically higher vaccine prices, burdening public health programs and taxpayers.
But if the vaccine products are as safe and injuries so extremely rare as claimed, then why would removing liability protections cause companies to flee the market or charge unaffordable prices? Unless the liability shield has been used to externalize those costs onto injured individuals and taxpayers?
The logical implication is unavoidable. If removing the liability shield would cause manufacturers to exit the market or dramatically increase prices, the manufacturers admit that vaccine damages represent a serious, recurring, and expensive problem, costly enough that companies believe they cannot afford to remain in the business, or to sell at current prices. Their own prediction functions as a direct admission that the financial risk of compensating injured people through settlements, judgments, or insurance is so substantial that it would render the vaccine business unsustainable.
Their own arguments certainly reveal that manufacturers lack confidence in their own products.
