The U.S. National Childhood Vaccine Injury Act does not stop people from suing vaccine manufacturers

CLAIM
“According to the 1986 National Childhood Vaccine Injury Act, you cannot sue a vaccine manufacturer if the vaccine has harmed and/or killed someone”
DETAILS
Inaccurate: The video alleges that the National Childhood Vaccine Injury Act prevents people from suing a vaccine manufacturer for vaccine injuries. This is false, as the Act still permits individuals to pursue legal action against a vaccine manufacturer under certain conditions, for example, if the individuals reject the decision made by the vaccine court, or if a vaccine manufacturer has been shown to be negligent. Furthermore, vaccines are not associated with autism or a higher risk of cancer, contrary to the claims in the video.
KEY TAKE AWAY
Multiple studies have established that vaccines are safe and not associated with increased rates of autism, cancer, or infertility. The National Childhood Vaccine Injury Act does not prevent people from suing a vaccine manufacturer for vaccine injuries. The U.S. Department of Health Resources and Services Administration explains that “Although the Act provides liability protections to vaccine manufacturers and vaccine administrators who administer covered vaccines in many circumstances, these protections are not absolute.” For instance, the Act does not provide manufacturers protection “when an individual files a petition and is requesting damages of $1,000 or less.” These protections also don’t hold if a vaccine manufacturer has been shown to be negligent.

FULL CLAIM: “According to the 1986 National Childhood Vaccine Injury Act, you cannot sue a vaccine manufacturer if the vaccine has harmed and/or killed someone”; “An infertility drug [in the tetanus vaccine] sterilized over 500,000 Kenyan women under the Bill and Melinda Gates Foundation”; “Vaccines are ‘unavoidably unsafe’”

REVIEW


A video recording of a 14 December 2020 event showed Rizza Islam and members of the group America’s Frontline Doctors purportedly confirming the “dangers of the COVID-19 vaccine.” Both parties have propagated health misinformation in the past (see here and here). The video went viral on Facebook and Instagram, and received more than 163,000 views by the time of this review’s publication.

Islam uses the rhetorical technique known as “just asking questions” to repeat several false claims about vaccines that have been debunked in the past. Health Feedback compiled a list of the main claims in the video below and explains why these claims are false/misleading.

Claim 1 (Inaccurate):

According to the 1986 National Childhood Vaccine Injury Act, you cannot sue a vaccine manufacturer if the vaccine has harmed and/or killed someone

According to the U.S. Department of Health and Human Services (HHS):

The National Childhood Vaccine Injury Act of 1986, as amended, created the National Vaccine Injury Compensation Program (VICP), a no-fault alternative to the traditional tort system. It provides compensation to people found to be injured by certain vaccines. Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement.

The VICP was established after lawsuits against vaccine manufacturers and healthcare providers threatened to cause vaccine shortages and reduce vaccination rates. The Program began accepting petitions (also called claims) in 1988.

It is false to say that the Act prevents people from suing vaccine manufacturers for vaccine injuries. From HRSA:

Under the Act, persons with petitions of vaccine-related injuries or deaths resulting from covered vaccines must first exhaust their remedies under the VICP before they can pursue legal actions against vaccine manufacturers or administrators.

To exhaust the remedies available under the VICP and pursue a legal action against a vaccine manufacturer or administrator outside of the VICP, a VICP petitioner must either withdraw his or her petition (if the special master of the U. S. Court of Federal Claims (Court) has failed to issue a decision or the Court has failed to enter judgment within the time provided by the Act) or reject the judgment under the VICP.

Although the Act provides liability protections to vaccine manufacturers and vaccine administrators who administer covered vaccines in many circumstances, these protections are not absolute.

There are instances when a vaccine manufacturer or administrator who gives a covered vaccine is not protected from liability by the Act, such as when an individual files a petition and is requesting damages of $1,000 or less. In this case, a civil suit against a vaccine manufacturer or an administrator may be permitted to be filed in state or federal court without first filing a petition in the VICP.

Furthermore, the multiple civil lawsuits that have been filed against vaccine manufacturers by anti-vaccine activists clearly prove the claim is false, as Vaxopedia points out.

Claim 2 (Inaccurate):
“The VAERS system […] established the vaccine court”

The claim is inaccurate. Firstly, VAERS, or the Vaccine Adverse Events Reporting System in full, allows people to report adverse events that occur following vaccination. It is not a legal entity. The VAERS website explains:

The Vaccine Adverse Events Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS.

Note that simply because an event occurred after vaccination does not mean that the vaccine caused the event. VAERS reminds users about this caveat as well:

VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine.

Secondly, the vaccine court is part of the U.S. Court of Federal Claims, as stated by HRSA:

U.S. Department of Health and Human Services (HHS) hosts the Program, conducts medical reviews of petitions, and makes Court-ordered compensation payments;
U.S. Department of Justice (DOJ) represents HHS in Court; and
U.S. Court of Federal Claims (the Court) makes the final decision regarding whether a petition is compensated and the type and amount of compensation.

This 2017 article published in Science briefly describes how the VICP works:

A cadre of medical experts at the VICP initially assesses injury claims, calling in lawyers from the Department of Justice to defend the government if they think the facts don’t support a vaccine injury claim. Eight senior attorneys—called special masters and appointed by judges on the U.S. Court of Federal Claims—rule on the claims. The court is rarely asked to determine whether an injury has occurred—that is virtually always abundantly clear—but whether a vaccine caused that injury.

Claim 3 (Inaccurate):

The CDC admitted that over 90 million people that received a polio vaccine came down with a cancer type of circumstance due to a cancer-causing agent known as SV40, also known as simian virus 40 in the polio vaccine.

This claim is misleading and was previously reviewed by Health Feedback here. As explained in our review, certain batches of polio vaccine were indeed contaminated with simian virus 40, leading millions of Americans to become exposed to SV40. However, “there is no reliable evidence that SV40 causes cancer in humans,” said Michael Imperiale, a professor of microbiology and immunology at the University of Michigan.

Dana-Farber Cancer Institute, a cancer treatment and research institute, stated that “vaccines won’t give you cancer.”

Claim 4 (Inaccurate):

MMR vaccine increased autism rate by 236% in African-American boys compared to Caucasian boys

This claim was also previously reviewed by Health Feedback and found to be inaccurate. It was also fact-checked by Snopes and found to be inaccurate. It is based on a study by chemical engineer Brian Hooker, that was later retracted by the journal. The journal editors explained their decision to retract the study, stating, “There were undeclared competing interests on the part of the author which compromised the peer review process. Furthermore, post-publication peer review raised concerns about the validity of the methods and statistical analysis, therefore the Editors no longer have confidence in the soundness of the findings.”

The methodological flaws were covered in detail in this ScienceBlogs article:

Hooker analyzed a dataset collected to be analyzed by a case-control method using a cohort design. Then he did multiple subset analyses, which, of course, are prone to false positives. As we also say, if you slice and dice the evidence more and more finely, eventually you will find apparent correlations that might or might not be real. In this case, I doubt Hooker’s correlation is real.

And, of course, there’s no biologically plausible reason why there would be an effect observed in African-Americans but no other race and, more specifically than that, in African-American males. In the discussion, Hooker does a bunch of handwaving about lower vitamin D levels and the like in African American boys, but there really isn’t a biologically plausible mechanism to account for his observation, suggesting that it’s probably spurious.

A 2014 ABC News article also covered this subject, in which experts also criticized Hooker’s study, calling it “fundamentally flawed”:

There’s no mention of how many children were included in [Hooker’s] analysis –- an omission that Vanderbilt University biostatistician Bill Dupont called ‘extremely rare’ –- and he failed to properly control for factors known to contribute to autism risk.

Multiple studies have concluded that vaccines don’t cause autism.

Claim 5 (Inaccurate):

An infertility drug [in the tetanus vaccine] sterilized over 500,000 Kenyan women under the Bill and Melinda Gates Foundationt”

This is another vaccine myth that has been debunked many times over. In fact, this article by Africa Check reports that the claim “is more than 20 years old and has been repeatedly debunked by [the] World Health Organisation (WHO) and others ever since.”

According to Africa Check, the claim is based on “a misunderstanding of a scientific study in India in 1994 that tested a birth control treatment.” This study tested the efficacy of a birth control treatment using the hormone human chorionic gonadotropin (hCG), which is produced in the body at high levels during pregnancy and is also excreted in the urine. The detection of hCG in urine is the basis of home pregnancy test kits:

For the Indian trial, researchers used a protein similar to the tetanus toxin as a carrier for the hCG. This would then cause the woman’s immune system to eliminate hCG to prevent pregnancy. The process was reversible, though.

An American anti-abortion organisation, claiming support from the Vatican, used this information to call for a congressional investigation into Mexico’s tetanus vaccination programme. Human Life International claimed that the tetanus vaccine being administered contained hCG which would leave women infertile.

In 2014, this claim was revived by some Kenyan bishops and a Catholic medical organization, who alleged that the tetanus vaccine contained hCG. However, this claim was based on test results which turned out to be unreliable, because the method used was only appropriate for human samples, not vaccine samples.

Claim 6 (Misleading):

Vaccines are ‘unavoidably unsafe’

This is another common talking point among the anti-vaccine community, which interprets the term to mean that vaccines are dangerous. However, the term “unavoidably unsafe” is a legal term that has a specific meaning that differs from the anti-vaccine interpretation, and takes into account the risk/benefit tradeoffs, as we will see below.

The term “unavoidably unsafe” comes from a comment to Section 402A of the Restatement (Second) of the Law of Torts, published by the American Law Institute:

Unavoidably unsafe products: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.

Dorit Reiss, a professor of law at the University of California Hastings College of the Law, explained the implications of the comment in this 2013 post:

The last sentence is the important one: A vaccine whose benefits outweigh its risks is not unreasonably dangerous or defective – even if the risks are as frightening as those attributed to the Pasteur vaccine, let alone modern vaccines, with their much lower risks. […]

Saying a product is ‘unavoidably unsafe’ makes it sound like the product is a bad one, when what the drafters meant was precisely the opposite: the comment was meant to apply only to ethical drugs or vaccines, i.e. where the benefits outweigh the risks.

Reiss summed it up thus:

The message comes through clearly: these products are beneficial enough that society wants to encourage their manufacturing. Therefore, while strict liability would be applied to most products, a manufacturer that prepared a drug or vaccine carefully and warned consumers of its risks should not have to pay for the side effects of a drug or vaccine whose benefits outweigh the risks unless that manufacturer can be shown to have been negligent.

In other words, ‘unavoidably unsafe’ is the opposite of ‘unreasonably dangerous’ in the Restatement’s categorization. It justifies a more favorable treatment because of those products’ extraordinary benefits.

READ MORE

Vaxopedia compiled a list of already-debunked anti-vaccine talking points together with explanations of why these talking points are false and/or misleading.

This article published in The Atlantic explains the rationale for the existence of the NVICP and how it has been co-opted in vaccine misinformation.

Published on: 19 Dec 2020 | Editor:

Health Feedback is a non-partisan, non-profit organization dedicated to science education. Our reviews are crowdsourced directly from a community of scientists with relevant expertise. We strive to explain whether and why information is or is not consistent with the science and to help readers know which news to trust.
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