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The U.S. Department of Health and Human Services violated federal law by failing to add the COVID-19 vaccine to the list of vaccines covered under the Vaccine Injury Compensation Program (VICP), according to a lawsuit filed by a man diagnosed with a severe blood-clotting disorder he alleges was caused by the vaccine.
Paul Brundage filed the lawsuit in January against then-U.S. Health Secretary Xavier Beccera. However, Becerra’s successor, Robert F. Kennedy Jr., became the target of the suit when he was confirmed in February.
The National Childhood Vaccine Injury Act of 1986, also known as the “Vaccine Act,” requires HHS to add vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine use in children or pregnant women to the Vaccine Injury Table within two years of the CDC’s recommendation.
According to the complaint, the two-year period has elapsed, and Brundage “should now be eligible to bring a claim for compensation for his injury in the United States Court of Federal Claims” under the Vaccine Injury Compensation Program (VICP).
However, Brundage is “not able to pursue compensation under the VICP” because HHS has not added the COVID-19 vaccine to the Vaccine Injury Table, the lawsuit states.
Under the Vaccine Act’s Citizen’s Action provision, citizens may pursue civil action against the HHS secretary “where there is alleged a failure of the Secretary to perform any act or duty” contained within the Vaccine Act.
The provision requires claimants to provide 60 days’ notice to the secretary, which the lawsuit states Brundage did in November 2024.
“The beauty of this provision is that it empowers the average citizen to ask a judge to force the HHS Secretary to take action,” said Ray Flores, senior outside counsel for Children’s Health Defense (CHD) and an expert on vaccine injury compensation cases. “It even provides for attorney fees.”
Flores said Brundage’s lawsuit is not the first or the only pending citizen’s action against the HHS. In May, Flores sued Kennedy for violating the 1986 Vaccine Act, which requires HHS to establish a task force dedicated to making childhood vaccines safer and to provide U.S. Congress with progress reports every two years.
Since Congress passed the act over 35 years ago, no health secretary — including Kennedy — has convened such a task force or reported to Congress on steps taken toward making vaccines safer. CHD is funding the lawsuit.
HHS must ‘do right by the people seriously injured’ by COVID vaccine
Attorney Altom Maglio of the District of Columbia law firm mctlaw, who represents Brundage, said he is “stumped as to why HHS has not added the COVID vaccine to the Vaccine Injury Table. … [HHS] seems to have no real argument as to why the Secretary has failed to do so.”
“The goal of this lawsuit is to have the United States do right by the people seriously injured by adverse reactions to the COVID vaccine,” Maglio said.
In May, under Kennedy, HHS filed a motion to dismiss Brundage’s lawsuit, stating HHS cannot add the COVID-19 vaccines to VICP until Congress adds a $0.75 excise tax to the shots.
The excise tax, levied on vaccines the CDC recommends for children, funds VICP payouts for injury claims connected to those vaccines.
Later in May, Brundage responded to HHS’ motion, arguing that the department’s claims contradict the requirements outlined in the Vaccine Act. The response said other vaccines, including hepatitis B and varicella, were added to the Vaccine Injury Table before an excise tax was enacted on them.
In his original complaint, Brundage said, “The Secretary’s failure to act is not based on a valid interpretation of the law, but on a refusal to comply with it.”
COVID vaccine injury compensation program ‘a bureaucratic black hole’
The lawsuit demands a court order requiring Kennedy to add the COVID-19 vaccines to the Vaccine Injury Table. According to TrialSite News, this would “unlock access to the VICP’s robust legal process, full hearings, and generous payouts, including up to $250,000 for pain and suffering.”
VICP, a government-run vaccine injury compensation program, is separate from the Countermeasures Injury Compensation Program (CICP), which covers COVID-19 vaccines. CICP was established under the Public Readiness and Emergency Preparedness Act (PREP Act) of 2005.
Under a PREP Act declaration, issued during an official public health emergency, manufacturers of vaccines and other countermeasures associated with a health emergency are exempt from liability for serious injuries or death caused by their products, except in cases of willful misconduct.
VICP is seen as being more generous in its payouts than CICP. As of June 1, VICP had awarded $5.4 billion in compensation claims since 1988, having approved nearly half of the claims filed during that period. By comparison, CICP has awarded just over $9.2 million in compensation since 2005.
CICP provides reimbursement for lost unemployment income, capped at $50,000 per year, and a one-time benefit of $370,000 for deaths. However, as a payer of last resort, CICP limits compensation to amounts not covered by insurance or other sources.
According to the most recent CICP data, of the 13,836 claims related to COVID-19 countermeasures filed to date, 75 were found eligible for compensation. As of June 1, 39 of those have been compensated. The overwhelming majority of claims were denied (4,338) or are “pending review or in review” (9,423).
Maglio called CICP “a bureaucratic black hole”:
“The CICP was never intended to handle something like the COVID vaccine. It was a compensation scheme drafted back in 2005 for a different purpose. It should never have been the only avenue for people injured by the COVID vaccine to obtain compensation for their injuries.
“There is no court, judge, record, due process or right of appeal to the courts. For almost all the 13,836 injured people that have filed claims in the CICP, it has been a waste of precious time and energy.”
The Biden administration declared the COVID-19 public health emergency over in May 2023. However, in December 2024, President Joe Biden extended the liability shield for COVID-19 countermeasures under the PREP Act through the end of 2029 — the 12th such extension since 2020.
Maglio said the PREP Act’s liability shield is “almost certainly unconstitutional,” and that while VICP “could certainly be improved, it is a far superior process” to CICP.
He said of VICP:
“Claims are filed in the Court of Federal Claims, there is the ability to present evidence and expert testimony, an ability to challenge evidence and testimony, a record is created, the case is decided by a judicial officer using legal precedent, and decisions can be appealed all the way up to the United States Supreme Court.”
But according to Wayne Rohde, author of “The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program” and “The Vaccine Court 2.0,” adding COVID-19 vaccines to VICP may normalize the continued administration of mRNA vaccines despite growing calls to withdraw these vaccines.
Rohde said:
“The growing evidence of the dangers of mRNA should conclude any reasonable person to not allow the COVID-19 related vaccines into the VICP. Once this is done, then all existing manufacturers will have a green light to convert existing traditional vaccines already part of the VICP table to be converted to mRNA.”
The Pfizer and Moderna COVID-19 vaccines use mRNA technology.
Rohde said he sent a proposal to Kennedy earlier this year suggesting that COVID-19 vaccines remain in the CICP program but under “a separate silo for litigating all related petitions” that will allow for “pain and suffering payments, attorney fees and medical expert costs to be paid out of a dedicated fund” not currently funded by CICP.
‘Public scrutiny’ of vaccine injury programs growing
TrialSite News reported that “public scrutiny” of vaccine injury compensation programs “is mounting.” The article cited an interview earlier this month during which Kennedy said HHS is “looking at ways to expand the VICP” and potentially extend the deadline for COVID-19 vaccine injury claimants to file claims.
In May, the CDC changed its recommendations on COVID-19 vaccines for healthy children. It now recommends that parents of healthy children consult their pediatricians and together decide whether to vaccinate against the virus.
As a result of this change, Flores said Brundage’s lawsuit is likely to be dismissed:
“In a strange quirk of fate, the chances for COVID-19 injuries being adjudicated in vaccine court were torpedoed after COVID-19 shots were removed from the recommended childhood schedule on May 27. For a vaccine to be covered by VICP, it must be recommended for routine administration to children or pregnant women. HHS’s reply brief raises this argument convincingly.
“Plaintiff’s case against the HHS was strong until the CDC removed the recommendation for healthy children to receive COVID-19 shots. Since the success of MCT’s lawsuit is contingent upon the CDC’s recommendation, the case is moot.”
Flores said Brundage first notified Beccera of his intention to file a citizen’s action — and subsequently filed his lawsuit — prematurely.
“When the case was filed, on Jan. 16, the HHS Secretary still had 24 days to adjust the Table. Plaintiff’s counsel also sent a premature 60-day warning letter to Secretary Becerra in November 2024 — well before any absolute duty arose,” Flores said.
But Maglio said a growing number of lawsuits are challenging the PREP Act and alleged limitations to existing vaccine injury compensation programs.
“There are multiple legal challenges to the immunity provisions pending and some will likely succeed,” Maglio said.
At least two recent lawsuits challenging the PREP Act have cleared initial judicial hurdles but remain pending.
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In March, the Supreme Court of North Carolina ruled that a lawsuit filed by the mother of a 14-year-old boy given a COVID-19 vaccine at school without consent can proceed. The court ruled the PREP Act does not preempt state law requiring parental consent for vaccination.
In November 2024, a federal court ruled that a lawsuit filed by a woman injured by AstraZeneca’s COVID-19 vaccine during a U.S. clinical trial can continue.
According to the complaint, AstraZeneca’s consent form for trial participants promised enrollees medical treatment in the event of illness or injury suffered during the study. The court rejected the drugmaker’s claim that a federal liability shield protects it from breach-of-contract claims.
In February, mctlaw filed a separate federal lawsuit against HHS, alleging the agency did not fulfill its legal obligation to adequately compensate COVID-19 vaccine injury victims.
Last week, Rep. Thomas Massie (R-Ky.) introduced legislation that would repeal the “sweeping” liability shield COVID-19 vaccine manufacturers currently enjoy.
Should Brundage’s lawsuit succeed, it “could open the door to thousands of long-blocked claims — and reshape the government’s approach to vaccine injury,” TrialSite News reported.
Related articles in The Defender
- CDC Updates Childhood Schedule With New COVID Vaccine Recommendation for Kids, But Advice for Pregnant Women Still Unchanged
- Nearly 10,000 Claims Pending as COVID Vaccine Injury Compensation Program Faces Possible Budget Cut
- COVID Vaccine Makers Get Another Free Pass as Biden Administration Extends Liability Shield Through 2029
- Massie Proposes to Make COVID Vaccine Makers Liable for Injuries, Opening Door for Thousands of Lawsuits
- Exclusive: Public Health Emergency in U.S. Set to Expire May 11 — But EUA Vaccines, Liability Shields Aren’t Going Away Anytime Soon
