“Yet, when considering compensation for the inevitable victims of the coronavirus vaccine, the Trump Administration…decided against following this familiar, well-charted path….The Administration...instead, decided to consign COVID vaccine claims to a novel, and largely untested, program, ominously titled the Countermeasures Injury Compensation Program (“CICP”)….It’s not right to ask–or compel–people to be vaccinated for the greater good and then to deprive them of fair treatment if they are one of the unlucky few hurt in the process. Toward that end, we believe that COVID-19 vaccine injury claims must be moved out of black hole that is the CICP and into the VICP.”
12/22/2020, “Coronavirus Vaccines and the Law,“ Stanford University Law School, Nora Freeman Engstrom, Peter H. Meyers
“As of the end of December [2020], the FDA has granted emergency use approval [also known as EUA, “Emergency Use Authorization”] to two coronavirus vaccines: those made by Pfizer-BioNTech and Moderna. Both require two shots, spaced weeks apart, and both appear to be extremely effective. By the end of 2020, all 50 states in the U.S. will receive tens of millions of doses, with states already administering the first set of shots. As we all wait for our turn to receive the vaccine, questions have arisen about risks, vaccine mandates, manufacturer liability and other topics. Here, Stanford Law’s Nora Freeman Engstrom and George Washington University Law School’s Peter H. Meyers discuss these and other questions….
“What’s the current process for those who are harmed by a coronavirus vaccine?
We have protected those hurt by vaccines consistently and unwaveringly since 1986, when Congress created the Vaccine Injury Compensation Program (“VICP”), a Program that protects vaccine makers from liability and which has transparently considered and evaluated some 22,000 claims for the regular childhood vaccines and the annual flu vaccine for children and adults. Under the Program, which is paid for by a $.75 excise tax on each vaccine dose administered, every person who can show she was injured by a covered vaccine, is entitled to compensation for medical expenses, lost income, and up to $250,000 for pain and suffering. Unlike in the tort system, she need not show that the doctor erred in the vaccine’s administration or preparation, that the vaccine was accompanied by an inadequate warning, or that the vaccine itself was defectively manufactured or designed. As such, the VICP is intended to provide adequate, though abridged, compensation to all individuals injured by covered vaccines via “less adversarial, expeditious, and informal proceeding[s].”
Yet, when considering compensation for the inevitable victims of the coronavirus vaccine, the Trump Administration has decided against following this familiar, well-charted path. Rather than routing these vaccine injury claims to the VICP, the Administration has, instead, decided to consign COVID vaccine claims to a novel, and largely untested, program, ominously titled the Countermeasures Injury Compensation Program (“CICP”).
What’s the CICP?
Created by Congress in 2005, the CICP arose out of concern that we were facing a potential H1N1 avian flu pandemic, as well as worries regarding potential bioterrorism threats from anthrax and other toxins. The CICP encouraged private industry to create “countermeasures” to such threats, including by developing new vaccines. To help spur this innovation, among other sweeteners, the CICP gave companies a powerful liability shield to protect them from future claims arising from injuries caused by the countermeasures they developed.
In particular, the CICP shields all manufacturers, distributors and dispensers of covered vaccines from liability unless they engage in “willful misconduct”—and any individual claiming an injury from a covered vaccine must file a petition for compensation not in the tort system, and not with the VICP, but instead with the U.S. Department of Health and Human Services.
How is the CICP different than the VICP?
The CICP is different than the VICP in many respects–and, worryingly, along every one of the dimensions where the two programs diverge, the CICP is less fair to the petitioner (the vaccine-injured person).
Consider transparency. At the conclusion of VICP proceedings, special masters issue written decisions so that the public—and independent researchers—can know which injuries have been found to be caused by which vaccines and which not. By contrast, the CICP is a place where all claims for compensation are decided by [HHS] agency officials in secret, without the opportunity for injured individuals to speak to or interact with decision-makers. Furthermore, in the CICP, all opinions are unpublished, so that the public (and researchers) never know which adverse events the CICP found were related to the vaccine and which were not.
Or, consider another important procedural safeguard: the right to an appeal an adverse ruling to a court. The VICP features meaningful judicial review to ventilate issues and correct errors. As noted above, a petitioner first adjudicates her claim before a special master in the U.S. Court of Claims. Then, if she is unhappy with the special master’s determination, the frustrated petitioner can appeal the determination to a judge of the U.S. Court of Claims, then to the U.S. Court of Appeals for the Federal Circuit, and even, possibly, to the U.S. Supreme Court. By contrast, in the CICP, all decisions to grant or deny compensation are unappealable to any judge.
The story regarding legal representation is similar. In the VICP, injured individuals are typically represented by attorneys and have the assistance of expert witnesses, both paid for by the program. The CICP offers neither. Injured individuals are supposed to navigate the program on their own.
Next, the VICP’s damage awards boast at least a modicum of generosity: In recent years, roughly three-quarters of VICP petitioners have received compensation. Here, again, the CICP comes up short. One of us has filed a Freedom of Information Act request to try to see how the CICP has worked thus far. (Such a request was necessary, as the CICP refuses to publish even summary statistics.) That request revealed that more than 90% of claims filed in the CICP for prior vaccine injuries have been rejected.
For successful petitioners, paths also diverge. As noted above, the VICP offers compensation for medical expenses, lost income, and up to $250,000 for pain and suffering. Compensation within the CICP is comparatively limited. Payments for medical expenses [not covered by petitioner’s own insurance] are authorized, but no compensation is allowed for pain and suffering, and only partial, prorated compensation is allowed for lost income.
Given the CICP’s shortcomings, what do you think should be done?
We certainly hope that COVID-19 vaccine injuries are few and far between. But, we are fooling ourselves if we think that there won’t be any injuries. And when those inevitable injuries take place, the victims need to be treated fairly by the U.S. government.
It’s not right to ask–or compel–people to be vaccinated for the greater good and then to deprive them of fair treatment if they are one of the unlucky few hurt in the process. Toward that end, we believe that COVID-19 vaccine injury claims must be moved out of black hole that is the CICP and into the VICP–a program that, as explained above, is far from perfect but much fairer.
An even better option also exists. Congress could adopt a compensation program for COVID-19 vaccine injury modeled on the highly successful program Congress passed in 2001 after the September 11th terrorist attacks. That program–the 9/11 Victim Compensation Fund--successfully adjudicated some 7,408 claims filed on behalf of those injured or killed, and it paid out over $7 billion quickly and equitably, and with transparency and generosity. Bipartisan action to enact such a program here, when we are in the grips of yet another national disaster, would no-doubt help to inspire necessary confidence in the vaccine project. The CICP–with its tight-fist and stacked deck–never will.”
“Nora Freeman Engstrom is a Professor of Law and Deane F. Johnson Faculty Scholar at Stanford Law School. She can be reached at nora.engstrom@law.stanford.edu.
Peter H. Meyers is a Professor of Law Emeritus at The George Washington University Law School where he directed the Vaccine Injury Litigation Clinic. He can be reached at Peter@law.gwu.edu.”
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Added: 8/30/21, Two additional sources on vaccine injuries and CICP vs VICP:
8/30/21, “Pfizer-BioNTech Still Immune From Lawsuits Over COVID-19 Vaccine After Federal Approval: Lawyers,“ Epoch Times, Meiling Lee
“Mark Sadaka, a medical litigations lawyer who has handled more than 175 vaccination cases, said full federal approval of the Pfizer-BioNTech vaccine doesn’t change the immunity status afforded to the vaccine manufacturer, so lawsuits can’t be filed if an individual has a severe reaction to the shot.
“The government encourages the production of vaccinations and medications used to fight a pandemic like COVID-19 by protecting the companies making them from lawsuits,” Sadaka told The Epoch Times via email. “In fact, the government has already labeled any future COVID-19 vaccine as a ‘countermeasure.’”
According to the Health Resource and Services Administration (HRSA), a countermeasure is a “vaccination, medication, device, or other item recommended to diagnose, prevent, or treat a declared pandemic, epidemic, or security threat.”…
Under amendments made to the 2005 Public Readiness and Emergency Preparedness (PREP) Act, COVID-19 vaccine manufacturers, providers, distributors, and program planners are immune from lawsuits related to vaccine injuries and death, unless it can be shown that there was willful misconduct in the production of the vaccine by the company.
John Howie, a trial lawyer focused on vaccine and personal injury, said the CICP is “the only remedy available to those who are injured by the vaccination.” The program was set up in 2010 and run by the HRSA, which is part of the Department of Health and Human Services (HHS).
“The damages are limited to: 1) a death benefit for those who die; 2) lost wages; and 3) medical bills not paid by insurance,” Howie told The Epoch Times in an email….
“There is no transparency like a true judicial process. There is no provision for attorney’s fees, thus making it difficult for any injured individual to even retain a lawyer. Any appeals are handled by people hand-selected by HHS to review the claim.”…
Howie, who was also a former member of the Advisory Commission on Childhood Vaccines, said the only way for COVID-19 vaccine-injured people to receive compensation is to add the approved vaccine to the National Vaccine Injury Compensation Program, also known as the vaccine court. It was created in 1988 as a no-fault system to compensate individuals injured by a vaccine (listed on the vaccine table) fairly, quickly, and efficiently….
“Until the COVID vaccines are added to the National Vaccine Injury Compensation Program [NVICP], the remedies for those who are injured are generally nonexistent. And, it will take an act of Congress—literally—for the COVID vaccines to become covered under the NVICP,” Howie said.
The [vaccine court] compensation program is funded by a 75 cent excise tax that’s charged to each vaccine administered by the provider, who later sends the money to the vaccine court fund. Since the inception of the program [in 1988], more than $4 billion (pdf) have been paid out.
[Medical litigations lawyer] Sadaka claimed that with the liability protection offered to vaccine companies, “there is no incentive to disclose safety risks of countermeasures outside of the simple goodwill of the large corporations that sell the product,” noting that “rare side effects are often swept under the rug in favor of profit.”…
An HRSA spokesperson said the agency has yet to develop a list of covered adverse events from COVID-19 vaccines.
“An injury table for COVID-19 medical countermeasures will be developed when there is sufficient data to meet the ‘compelling, reliable, valid, medical, and scientific evidence’ standard,” Christy Choi, deputy director of HRSA, wrote in an email to The Epoch Times. “When a table is developed, it is published in the Federal Register, with an opportunity for public comment, and is posted on the CICP website.””…
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Added: 8/30/2021, Washington Post article, vaccine injuries and CICP vs VICP:
“In early 2020, after the coronavirus emerged, Health and Human Services Secretary Alex Azar invoked the PREP Act to “provide liability immunity for activities related to medical countermeasures against covid-19.” So that covers all vaccines that might be produced to combat the coronavirus, whether fully authorized [what about “fully approved”] or not.
The PREP Act designation means that claims related to coronavirus vaccines are covered by the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), which was set up to handle vaccine lawsuits.
In other words, a person cannot sue a manufacturer for an injury caused by a vaccine or other product listed as a countermeasure, but they can seek compensation from CICP filing a claim. The intent of the law is to urge manufacturers to quickly gear up to combat a possible pandemic without fear of lawsuits. (There is an exception in the law if a person can prove “willful misconduct” by a manufacturer.)
Claims filed under CICP for lost income are capped at $50,000 per year and unlike the VICP it does not provide any compensation for pain, suffering, emotional distress, or similar damages. Cases filed under VICP also have limitations; they are heard in the U.S. Court of Federal Claims, where there are no juries and a court-appointed special master decides the case.
The CICP website shows that as of Aug. 2, 686 people have alleged injuries or deaths from coronavirus vaccines but so far no countermeasure claims have received any compensation….
“There are no liability or compensation differences between a countermeasure approved under an EUA or one that has received full FDA approval,” confirmed an HHS spokesperson.”…8/30/21, “The false claim that the fully-approved Pfizer vaccine lacks liability protection,” Washington Post, Glenn Kessler
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Comment: On major issues, Trump's actions are the opposite of his words. He has endlessly gushed about how great Covid vaccines are, yet his brutal legal action in March 2020–away from the cameras–shows he has big doubts about their safety. Americans have long had recourse to the “vaccine court” (VICP) for relief from vaccine injuries, but Trump removed that option for those with Covid vaccine injury complaints. Recourse is now nearly zero, per above articles.
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