U.S. Health Secretary Robert F. Kennedy Jr. is accused of violating requirements of the National Childhood Vaccine Injury Act of 1986, which includes promoting the development of safer vaccines. The lawsuit, filed by attorney Ray Flores, is funded by Children’s Health Defense.
JULY 21, 2025
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Attorney Ray Flores is suing U.S. Health Secretary Robert F. Kennedy Jr. for failing to establish a task force dedicated to making childhood vaccines safer, as mandated by federal law.
The lawsuit alleges Kennedy is violating the National Childhood Vaccine Injury Act of 1986, which requires the secretary of the U.S. Department of Health and Human Services (HHS) to promote the development of safer childhood vaccines that cause “fewer and less serious adverse reactions” than existing ones.
The act requires HHS to establish a task force that includes the health secretary, the commissioner of the U.S. Food and Drug Administration, the directors of the National Institutes of Health and the Centers for Disease Control and Prevention (CDC).
It also requires the health secretary to provide Congress with progress reports every two years.
Since the U.S. Congress passed the act over 35 years ago, no health secretary — including Kennedy — has reported to Congress on steps taken toward making vaccines safer.
Flores said in the complaint that because more than 100 days have passed since the Trump administration took office, “any grace period for Mr. Kennedy to rectify the failure of his predecessors has ended.”
Mary Holland, CEO of Children’s Health Defense — which is funding the lawsuit — said it is “blackletter law that the HHS secretary must convene a task force on how to make vaccines safer.”
“This is part of the 1986 act itself,” she said. “That no secretary has done so since the passage of this law is a blow to the rule of law. I hope and trust that the current secretary will fulfill his obligation to Congress’s mandate.”
Flores said the 1986 act includes a broad provision allowing citizens to sue the secretary if the requirements are not met. His lawsuit asks the court to compel Kennedy to comply with the mandate to set up a task force and submit biennial reports to Congress.
Flores told The Defender it was “astonishing” that HHS hasn’t fulfilled its responsibility to make vaccines safer. “Perhaps a little encouragement from a federal judge will help move this along,” he said.
Kennedy filed a similar lawsuit against HHS when he was a practicing attorney
Congress passed the National Childhood Vaccine Injury Act after a crisis in the late 1970s and early 1980s when Wyeth’s (now Pfizer’s) diphtheria-tetanus-pertussis (DTP) vaccine caused seizures, serious brain injury or death among children.
Between 1980 and 1986, people injured by vaccines filed more than $3 billion worth of damage claims with U.S. civil courts against vaccine manufacturers, most of which were for the DTP vaccines.
After lawsuits revealed that Wyeth knew of the risks, juries began authorizing large payouts to some DTP-injured children. The payouts threatened to bankrupt the vaccine insurance industry.
The publicity also generated public concerns about vaccine adverse events.
In 1986, Congress passed the law, giving the pharmaceutical industry broad protection from liabilityand creating a framework to compensate children injured by compulsory vaccines. The National Vaccine Injury Compensation Program (VICP), a no-fault administrative system, adjudicates vaccine injury claims.
Although it is notoriously difficult to win compensation in the VICP, it has paid out over $5.2 billion to injury victims since its inception. Flores’ lawsuit alleges the number would be significantly higher if vaccine manufacturers had to defend themselves in federal court, rather than in the VICP.
A lesser-known part of the 1986 law mandated the pursuit of safer vaccines and the establishment of the task force. Like the VICP, this aspect of the law has long been a point of controversy.
In 2018, when Kennedy worked as a lawyer, he and co-counsel Aaron Siri filed a lawsuit against HHS in a New York district court, seeking copies of the biennial reports after the agency failed to respond to Freedom of Information Act requests.
Kennedy’s lawsuit revealed that no reports were ever submitted. HHS created the first task force in 1990, but it was disbanded in 1998, with no reports produced, HHS told plaintiffs.
More recently, former HHS Secretary Xavier Becerra, who left office in January, confirmed that no health secretary had ever provided safety improvement reports to Congress.
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The MAHA commission report released in May referenced this lawsuit, stating that HHS has faced litigation for “failing to fulfill basic duties under the Mandate for Safer Childhood Vaccines,” including the biennial reports to Congress.
Flores’ lawsuit alleges Kennedy knows there is a lack of rigorous safety testing for childhood vaccines, as shown by his many public statements on the issue, including since taking office.
For example, Kennedy stated that “except for the COVID vaccine, none of the vaccines on the CDC’s childhood recommended schedule were tested against an inert placebo, meaning we know very little about the actual risk profiles of these products.”
Flores said that without better safety data available to the American public, he and his family cannot adequately make informed decisions about childhood vaccines for his daughter.
Without that data, he was forced to relocate his family from California, where school vaccine mandates are “draconian,” to Nevada, which allows medical and religious exemptions, according to the lawsuit.
Flores said the steps undertaken by the MAHA commission to investigate vaccines or make them safer can’t stand in for the legal requirements under the 1986 law.
The same conditions that led Kennedy to file a similar lawsuit in 2018 are still in place, Flores alleged. Now that he is in the position to rectify the issue, Kennedy should be compelled to do so.
Related articles in The Defender
- Did MAHA Report Go Far Enough on Vaccines? Fans and Critics Weigh In
- Kids, Vaccines and Autism: Will a New Legal Strategy End the Decades-long Battle for Truth and Justice?
- ‘RFK, Polio Vaccines, the Media and Me’: Lawyer Corrects New York Times Misinformation
Brenda Baletti, Ph.D.
Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
Categories: Health Policy, Legal, Policy, Toxic Exposures, Vaccine Injury, Vaccines, Vaccines
Tags: Childhood Vaccination Schedule, Children’s Health, Health Policy, Legal – CHD Lawsuits, Robert F. Kennedy Jr. – RFK Jr., U.S. Department of Health and Human Services – HHS, Vaccine Injury, Vaccine SafetyREPUBLISH THIS ARTICLE
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