Breaking: Government Program for Compensating COVID Vaccine Injuries Is ‘Unconstitutional,’ Lawsuit Alleges
Two women, with support from Children’s Health Defense, are suing the government agency that oversees the compensation program for COVID-19 vaccine injuries.
Two women, with support from Children’s Health Defense (CHD), are suing the government agency that oversees the compensation program for COVID-19 vaccine injuries.
Angela K. McInish and Christina Gay Fible, who said they developed debilitating COVID-19 vaccine injuries, allege the program violated their constitutional rights by setting eligibility criteria so restrictive that neither woman qualifies for compensation.
The lawsuit, filed late Monday against the Health Resources & Services Administration (HRSA), alleges the Countermeasures Injury Compensation Program (CICP) violates the Constitution’s due process and equal protection provisions because it leaves the women with no legal remedy for their injuries.
The CICP was established under the Public Readiness and Emergency Preparedness (PREP) Act. The program processes claims for countermeasures, including COVID-19 shots, administered during a public health emergency.
The PREP Act protects COVID-19 vaccine makers, healthcare workers and others who administer the vaccines from liability for most types of injuries caused by the vaccines — so those injured by the vaccines can’t sue in a regular court of law.
The only course of action for people injured by COVID-19 vaccines is to file a claim with the CICP. The claim must be filed within 12 months after the injury occurred.
CICP says it “provides compensation for covered serious injuries or deaths” caused by covered countermeasures. But the women’s attorney, Ray Flores, said the program’s definition of “serious physical injury” is “arbitrary.”
The federal government defines “serious physical injury” as injuries that are “life-threatening,” result in “permanent impairment of a body function or permanent damage to a body structure,” or require “medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.”
McInish and Fible allege the vaccines caused multiple injuries that have impaired their ability to work and live normal lives — but their injuries fall below CICP’s threshold.
“It is fundamentally unjust and unconstitutional under the U.S. Constitution for someone to suffer substantial injury and have absolutely no path to recovery or accountability,” said CHD CEO Mary Holland. “This simple lawsuit on behalf of two women makes it clear that U.S. courthouse doors may no longer remain closed to the vast majority of people injured by COVID shots.”
CHD General Counsel Kim Mack Rosenberg told The Defender the lawsuit highlights a “flaw in the CICP that has largely gone unrecognized” — namely, that “potentially millions” of people have “suffered tremendous harms that the government does not consider ‘serious’” and have been “left without any remedy” as a result.
McInish, from Georgia, and Fible, who lives in Indiana, filed their suit against HRSA in the U.S. District Court for the District of Columbia. HRSA is a division of the U.S. Department of Health and Human Services.
The lawsuit names HRSA Administrator Thomas J. Engels in his official capacity. In addition to legal fees, the suit asks the court to declare the CICP unconstitutional and order the program administrator to open the compensation process to a broader range of injuries.
105 doctor appointments over 2-and-a-half years
McInish received two doses of the Pfizer-BioNTech COVID-19 vaccine in 2021. She developed an autoimmune disorder, small fiber neuropathy, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome, tinnitus and heart palpitations, leaving her unable to work.
She alleges that over two-and-a-half years, she had over 105 doctor appointments to treat her substantial, painful symptoms.
Fible received two doses of Moderna’s COVID-19 vaccine in 2021. She said the vaccines caused her to develop high blood pressure, tachycardia, pelvic pain, tremors, leg numbness, weight loss, frequent urination and insomnia. She had to sit upright for several months.
“While the injuries have subsided somewhat from their zenith, Plaintiffs remain impaired and have no access to any remedy,” the complaint states.
According to the lawsuit, the lack of an alternative remedy violates the plaintiffs’ Fifth Amendment rights to due process and their 14th Amendment equal protection rights.
“Plaintiffs did not, and could not apply” for compensation, the complaint states. “Justice to remedy their harms is completely out of reach.”
The lawsuit alleges that the CICP is “designed to exclude the vast majority of those injured” and subverts the “rights to bodily autonomy and to be free of physical harm from others.”
Flores said that, unlike prior cases challenging CICP, the new lawsuit is “narrowly pled to show that plaintiffs and the vast majority of the injured are left without any remedy whatsoever.”
1.5 million injured by COVID vaccines don’t qualify for compensation
According to OpenVAERS, over 1.5 million people who received COVID-19 vaccines sustained injuries that weren’t life-threatening and were not life-ending. Under the CICP’s criteria, these people don’t qualify for compensation.
The sole exception to the PREP Act’s liability shield is willful misconduct — defined as intentional acts (or omissions) done with knowledge that harm is highly probable.
However, the PREP Act requires that willful misconduct claims first be adjudicated through CICP — even though CICP bars claims that fall below its “serious physical injury” threshold.
This creates a classic — and likely unconstitutional — catch-22 scenario for prospective claimants, according to the lawsuit.
Former U.S. Health Secretary Xavier Becerra declared the end of the COVID-19 public health emergency in May 2023. However, the declaration didn’t end a separate public health emergency that leaves COVID-19 covered under the PREP Act.
In December 2024 — just before the end of former President Joe Biden’s term — Becerra extended the PREP Act’s liability shield for COVID-19 countermeasures until Dec. 31, 2029. It was the 12th extension since 2020.
According to the lawsuit, even with the extensions, many people who meet CICP’s stringent criteria to file an injury claim have seen those applications habitually rejected.
As of Dec. 1, CICP has compensated just 42 COVID-19 vaccine-related claims, out of 14,046 total claims filed, or less than 0.3%. A total of 87 claims were found “eligible for compensation,” while 6,186 claims have been denied, and 7,773 are “pending review or in review.”
CICP’s median payout for the COVID-19 vaccine injury claims it has compensated is $4,131.50, while the average payout amount is $155,147.61. However, the latter figure is skewed by two unusually large payouts. Without those payouts, the average compensation amount falls to $5,126.65.
“There has never been a successful challenge to CICP,” Flores said. “A ruling that CICP’s narrow application process is unconstitutional could open the door for many more” COVID-19 vaccine injury victims to submit claims to CICP.
To support this lawsuit, and other work by Children’s Health Defense on behalf of the vaccine-injured, please make a donation here.
Related articles in The Defender
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Lawsuit on Behalf of Vaccine-injured Seeks to Strike Down ‘Unconstitutional’ PREP Act