Lawsuit Challenges Federal Vaccine Injury Compensation Program

A recently filed lawsuit is challenging the constitutionality of the federal Countermeasures Injury Compensation Program (CICP).

In a complaint filed in the U.S. District Court for the Western District of Louisiana last month, attorneys for a group of plaintiffs alleging they have been seriously injured after they "did the right thing" and received a COVID-19 vaccine wrote that the CICP is the "epitome of a kangaroo court or a star chamber -- a proceeding that ignores recognized standards of law and justice, is grossly unfair, and comes to a predetermined conclusion."

The CICP is meant to provide compensation for serious injury or death as a result of the administration of a countermeasure, such as vaccines, to address a public health emergency, according to the Health Resources & Services Administration (HRSA), a division of HHS. Both HRSA and HHS are named as defendants in the case.

But the plaintiffs argued that the court should "strike down" the Public Readiness and Emergency Preparedness Act of 2005 that was used to create the CICP "to the extent it fails to provide basic due process protections, transparency, and judicial oversight."

"The CICP as it functions now is fundamentally inconsistent with Congress' intent," the complaint noted. "CICP claims are consistently lost, ignored, denied, or caught up in the years-long purgatory of government bureaucracy."

In an email to MedPage Today, Aaron Siri, JD, the managing partner of Siri & Glimstad, who is representing the plaintiffs, wrote that "leading up to when we filed, there had been hope that Congress was going to correct the serious issue of failing to provide often desperately needed support for those injured by COVID-19 vaccines."

However, to date, there has been little in the way of resolution or compensation for plaintiffs "wholly consumed by survival needs," but who "recognize the importance of the challenge they currently bring" to the court, the complaint noted.

As of October 1, there have been 12,233 CICP claims related to COVID countermeasures. The CICP has compensated six of those claims -- five for myocarditis and one for anaphylaxis.

Though the average payout related to COVID countermeasures has been less than $3,000, the CICP's average payout on injuries tied to the H1N1 flu vaccine was more than $198,000, according to the complaint.

"It's got legs," Katharine Van Tassel, JD, MPH, of Case Western Reserve University School of Law in Cleveland, told MedPage Today. "I think it's a good case."

A significant concern is that a lack of compensation will fuel anti-vaccination efforts, she explained, noting that she believes there may be similar legal challenges to the CICP's constitutionality that follow suit.

Renée Gentry, JD, director of the Vaccine Injury Litigation Clinic at George Washington University Law School in Washington, D.C., said that the "best way to preserve" an effective vaccination program is to "have a safety net under it."

"That's the real fear, that when the next pandemic comes ... now you've got a group of people who were pro-vaccine who now are going to think twice," she told MedPage Today.

Overall, the current lawsuit alleges that the CICP claims submission and review process is "shrouded in secrecy," including "undefined standards" and "no clear process or timeline" for review. The government also does not provide the opportunity for discovery nor does it identify expert witnesses in making determinations.

The CICP "appears unable to adequately compensate -- further evidence that the program is simply theatre," the complaint noted. "If COVID-19 claims were compensated at CICP's historical rate, CICP would face around $21.16 million in compensation outlays and $317.94 million in total outlays which is 72.1 times its current balance."

Furthermore, the CICP "fundamentally differs" from other compensation programs in its lack of judicial oversight, the complaint added. For instance, the National Childhood Vaccine Injury Act of 1986 -- which led to the National Vaccine Injury Compensation Program (VICP) -- is subject to judicial oversight from the U.S. Court of Federal Claims.

Since 1988, total compensation paid over the life of the VICP program is approximately $5 billion, according to HRSA data. (The program is funded by a $0.75 excise tax on vaccines recommended by the CDC for routine administration to children, while the CICP is backed by appropriated funds.)

Ultimately, the plaintiffs in the case are asking the court to declare unconstitutional the provisions that established the CICP, and prohibit these provisions from being enforced until all COVID vaccine injury claims are allowed to be brought to the U.S. Court of Federal Claims, or the CICP is reformed.

Neither HHS nor HRSA immediately responded to requests for comment on the lawsuit.

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