HR-4668-119
Referred to the House Committee on Energy and Commerce.
Sponsored by Paul Gosar (R-AZ)
What it does
This bill would allow individuals to sue vaccine manufacturers and administrators directly in state or federal court for vaccine-related injury or death, without first going through the National Vaccine Injury Compensation Program (VICP). It would eliminate time limits for filing VICP petitions, repeal the exclusive-remedy and standards-of-responsibility provisions that currently shield manufacturers from most lawsuits, and remove COVID-19 vaccines from the definition of "covered countermeasure" under the PREP Act, stripping them of the liability immunity that applies to emergency countermeasures.
Who benefits
People who believe they were injured by a vaccine, including COVID-19 vaccines, and their attorneys, who would gain the ability to sue manufacturers directly in court rather than being limited to the administrative compensation program. Plaintiffs' law firms specializing in product liability litigation would likely see increased business.
Who is hurt
Vaccine manufacturers (including major pharmaceutical companies) would face increased litigation exposure and costs, which could be passed on through higher vaccine prices. Vaccine administrators such as pharmacies, clinics, and doctors could face new lawsuit risk. Public health officials and researchers warn manufacturers may reduce vaccine development or supply due to liability risk, potentially affecting the broader population's access to vaccines, including children relying on routine immunizations.
Supporters argue
Supporters argue that the current liability shield removes accountability for vaccine manufacturers and denies injured individuals full access to the civil court system, forcing them into an administrative program with capped compensation and procedural hurdles. They contend that ending the carveout, especially for COVID-19 vaccines, restores the same legal recourse available to consumers injured by virtually any other product, citing concerns that manufacturers have insufficient incentive to ensure safety without ordinary tort exposure.
Opponents argue
Opponents argue that the VICP was created in the 1980s specifically because unlimited tort liability was driving manufacturers out of the vaccine market, threatening public health by reducing vaccine supply. They contend that removing these protections could cause manufacturers to raise prices, limit product lines, or exit the market entirely, potentially reducing access to routine immunizations that prevent outbreaks of diseases like measles and whooping cough.
Constitutional context
Congress has broad authority under the Commerce Clause (Art. I, §8, cl. 3) and the Necessary and Proper Clause to structure tort liability and preemption regimes for products moving in interstate commerce, as it did when creating the VICP and PREP Act immunity; no Supreme Court case directly requires or forbids Congress from repealing its own statutory liability shield, so this is best understood as an exercise of ordinary legislative discretion rather than a settled constitutional question.
Checks and balances
Congress would be exercising its legislative authority to remove statutory liability protections it previously created, shifting adjudication of vaccine injury claims from a specialized administrative forum (with judicial review by the Court of Federal Claims) to ordinary state and federal courts.
Historical precedent
The National Childhood Vaccine Injury Act of 1986 created the VICP in response to a wave of tort lawsuits threatening vaccine supply, and the PREP Act of 2005 later extended similar immunity to emergency countermeasures; this bill would substantially reverse both frameworks.