New Legislation Would Remove Liability Protection for Vaccine Manufacturers

The bill would amend federal law to let people sue manufacturers over alleged vaccine injuries without limitations.

Rep. Paul Gosar, (R–Arizona) during a hearing on Capitol Hill in Washington in a file photograph. Bill Clark/Pool/Getty Images

A new bill introduced in Congress would end the liability protection currently afforded to vaccine manufacturers.

H.R. 4668, the End the Vaccine Carveout Act, would amend federal law to open manufacturers up to more potential lawsuits than are currently allowed.

Under a 1986 law called the National Childhood Vaccine Injury Act, people who allege vaccine injuries, or deaths from vaccination, can only sue manufacturers after they file a petition with a government compensation program. The claim must also be adjudicated before they can file suit in court.

The program has a lengthy backlog; it currently takes years for a decision to come.

The new bill, introduced on July 23, would allow people to go straight to court to file civil suits against manufacturers.

The National Childhood Vaccine Injury Act also states in part that manufacturers are not liable for any vaccine-related injuries or deaths “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” And it only allows suits if manufacturers engaged in fraud, wrongfully withheld information from the government prior to vaccine approval, wrongfully withheld information after approval, or engaged in “other criminal or illegal activity relating to the safety and effectiveness of vaccines.”

The new bill would repeal exemptions from liability contained in the act.

Rep. Paul Gosar (R-Ariz.) introduced the bill.

“Current immunity provisions unfairly shielding Big Pharma from the harms caused by their products prevents those injured by vaccines to pursue a civil lawsuit in state or federal court. 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,” Gosar said in a statement on July 24.

He added later that the bill “puts patients over profits by stripping away current liability protections and removes the statute of limitations 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.”

Gosar introduced the bill in 2024, but it never gained traction in the split Congress. Republicans now control both chambers, although about the same number of members, 29, cosponsored the new version as the 30 who cosponsored the former version.

Mary Holland, president of the nonprofit Children’s Health Defense, was among those who voiced support for the legislation.

“[The bill] is exactly what we need to ensure vaccines are held to the highest standards of safety and effectiveness, just like almost all other products,” she said in a statement.

PhRMA, a trade group that represents vaccine manufacturers, did not respond to a request for comment by publication time.