Vaccine Injury Act Payouts Draw Scrutiny, Calls for Reforms From HHS Secretary

Comments made by RFK, Jr. come as some lawmakers are calling for vaccine makers to be stripped of their liability protections for devastating side effects linked to their products.

The U.S. Health and Human Services Secretary is calling for sweeping reforms to the Vaccine Injury Compensation Program (VICP), amid growing concerns that it no longer serves the individuals it was created to protect.

Originally established under the 1986 National Childhood Vaccine Injury Act, the VICP was designed to ensure a steady supply of vaccines by shielding manufacturers from excessive litigation, while providing a streamlined process for compensating those injured by rare vaccine side effects. The program is funded through a $0.75 surcharge on every vaccine dose administered in the U.S.

However, in a posting on X, HHS Secretary Robert F. Kennedy Jr. criticized the program for drifting from its original mission. He argued that the VICP now prioritizes financial sustainability over fairly compensating Americans, particularly children, who suffer vaccine-related injuries.

Kennedy indicated that his proposed reforms would refocus the program on its intended purpose and lead to an increase in payouts for legitimate claims under the Vaccine Act.

The current process requires those seeking vaccine injury payouts to file a petition with the Vaccine Court, which determines if they are due compensation, and then pays them from a trust fund. The Court has paid out about $5.4 billion to 12,000 petitioners, according to Kennedy.

“But the VICP no longer functions to achieve its Congressional intent. Instead, the VICP has devolved into a morass of inefficiency, favoritism, and outright corruption as government lawyers and the Special Masters who serve as Vaccine Court Judges prioritize the solvency of the HHS Trust Fund, over their duty to compensate victims.”

-Robert F. Kennedy, Jr., HHS Secretary

According to Kennedy, Special Masters appointed by the Court to adjudicate the claims dismissed more than half of them, despite the system being set up to favor petitioners. In addition to dismissing claims that have merit, he also accused them of frequently delaying compensation for years.

Furthermore, he claims that most cases take more than five years to resolve, with many dragging on for over a decade. According to his post, claimants are often left feeling penalized simply for seeking compensation.

Critics have raised concerns that this will evolve into an attack on the legitimacy of vaccines overall, citing a record of Kennedy supporting anti-vaxxer conspiracy theories. Last month Kennedy fired the entire U.S. Centers for Disease Control and Prevention’s vaccine advisory board.

However, the call for reform follows a June hearing of the U.S. Senate Permanent Subcommittee on Investigations addressing vaccine injuries. The subcommittee chair, Senator Ron Johnson of Wisconsin, a Republican, and Ranking Member Senator Richard Blumenthal, a Democrat, have both indicated they are considering legislation to strip liability protections from vaccine manufacturers.

In the House of Representatives, Congressman Chip Roy, of Texas, has proposed a bill, H.R. 1432, that would do just that. There has been no movement on the bill since it was introduced in February.

Gardasil Vaccine Lawsuits Challenge Liability Protections

The debate over vaccine injury compensation is unfolding against the backdrop of a number of Gardasil HPV lawsuits being pursued by individuals who have developed serious autoimmune and neurological side effects.

Merck & Co., the manufacturer of Gardasil, is currently defending claims that the vaccine caused injuries such as postural orthostatic tachycardia syndrome (POTS), premature ovarian insufficiency (POI), and other long-term health conditions in young recipients. Plaintiffs allege that Merck failed to adequately warn about these risks, and that the company aggressively marketed the vaccine while downplaying adverse event reports.

Nearly 200 Gardasil lawsuits have been centralized as part of a federal multidistrict litigation (MDL) in the U.S. District Court for the Western District of North Carolina since 2022, where Judge Kenneth D. Bell was overseeing coordinated pretrial proceedings. The litigation had been moving toward a series of early bellwether trials, designed to test key scientific evidence and legal arguments before a jury. However, in March 2025, Judge Bell issued a controversial ruling that excluded expert testimony linking Gardasil to POTS, leading to the dismissal of all remaining POTS-related injury claims.

Merck successfully argued that the plaintiffs’ failure-to-warn claims were preempted by federal law, asserting that it lacked sufficient evidence to persuade the FDA to update Gardasil’s warning label. The judge agreed, granting summary judgment and ending all pending lawsuits in the MDL, at least for now.

On July 11, plaintiffs filed an appeal with the U.S. Court of Appeals for the Fourth Circuit, challenging the dismissal. The appeal contests the exclusion of key expert witnesses and the trial court’s conclusion that federal law shielded Merck from liability. The Fourth Circuit has agreed to hear the appeal, with opening briefs due by August 25 and response briefs due by September 24, 2025. A decision on whether oral arguments will be held is still pending.

If the appellate court reverses the trial judge’s rulings, the Gardasil cases could be reinstated and move forward toward bellwether trials. However, if the dismissal is upheld, plaintiffs may escalate the case to the U.S. Supreme Court, potentially delaying resolution for months, or even years.

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