The anti-vaccine world loves its myths, because, lacking any real scientific evidence supporting their outlandish claims, fairy tales are all they have. Not that I like picking and choosing the worst of the anti-vaccine urban legends, but the vaccine court myths are among the most egregious and ridiculous.

Although there are a lot of vaccine court myths, I wanted this article will focus on just three critical points:

1. The vaccine court vs. civil courts for plaintiffs.
2. Vaccine manufacturers are immune to lawsuits.
3. Billions of dollars have been paid out to “victims.”
4. The vaccine court said that vaccines cause autism.

Let’s get to the article.

What is the vaccine court?

Maybe the first step in dispelling vaccine court myths should be to accurately describe it. The “vaccine court” isn’t the official name – it is really the Office of Special Masters of the US Court of Federal Claims. In the vaccine court, Special Masters are appointed by the Court to adjudicate vaccine claims – they are considered experts in both vaccines and the law surrounding them.

The vaccine court administers a no-fault system for litigating vaccine injury claims. The Special Master acts, in these cases, as both judge and jury. And decisions by Special Masters can be appealed through the typical appellate system of the USA.

The National Vaccine Injury Compensation Program (VICP or NVICP) administers the whole system. It was established by the 1986 National Childhood Vaccine Injury Act, which was signed into law in response to a threat to the vaccine supply. During the 1980s, there was a scare about the whole-cell DPT vaccine (see Note 1), which most public health officials thought was unfounded.

Despite the overwhelming science that the DPT vaccine was safe, large awards against vaccine manufacturers were given to some plaintiffs. As a result, most DPT vaccine manufacturers ceased distributing the vaccine in the USA (or shutting down manufacturing itself), which lead to public health officials fearing the loss of herd immunity, which is a form of population-level protection from infectious disease outbreaks that occur when a large percentage of a population has been vaccinated.

The NVICP is funded by an excise tax of US$0.75 on each dose of vaccine. This fund is almost exclusively used to fund claims allowed by the vaccine court – these include compensation to cover medical and legal expenses, loss of future earning capacity, up to US$250,000 for pain and suffering, and a death benefit of up to US$250,000.

The system is only for routine childhood vaccines — these include nearly 20 different vaccines. Adults and adult vaccines, with a few exceptions, are excluded from filing NVICP claims and must pursue their cases in Federal or state civil courts.

To win an award in vaccine court, the petitioner must have experienced an injury from the vaccines, sometimes called a “table injury” — vaccine injuries that are included in an extensive table maintained by the NVCIP (pdf). Separately, for non-table injury claims, the plaintiff must show a causal connection between the vaccine and the injury. The burden of proof in these cases follows the civil law preponderance-of-the-evidence standard – that is, over 50% of the evidence supports the claim.

Denied claims can be appealed, all the way to the Supreme Court. In addition, plaintiffs who have been denied claims can pursue them in civil courts, although it is very rare.

Finally, there are very small exceptions in which you simply cannot sue for harm either through the NVICP or in civil court. For example, if the US Government required smallpox vaccinations after a terrorist or biological warfare attack, no matter what happened after the vaccination, the vaccine manufacturers are immune to lawsuits. They could sue the US Government, but that probably would not work out in favor of the plaintiff.

COVID-19 vaccines are, at this time, not covered by the NVICP. Professor Dorit Rubinstein Reiss explained the reasons for this exclusion in a detailed article. Essentially, the Public Readiness and Emergency Preparedness Act (PREP) allows the Secretary of Health and Human Services to issue a statement limiting liability for a product during an emergency. The Secretary issued such a declaration for COVID-19 products and vaccines. 

The statement completely isolates “manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States” from liability for harms or deaths from a COVID-19 vaccine until October 1, 2024. In other words, you cannot sue these manufacturers at all.

Vaccine court myths – vs civil courts

So the first myth is that the vaccine court is an inferior choice compared to your typical civil court. Of course, this results in a trope that somehow vaccine manufacturers have an easier time in the NVICP system rather than in a typical state civil court.

That would be a good point if it were at all true.

The above chart compares the NVICP system versus the civil court system. As you might notice, this particular myth is not supported by the facts.

On a point-by-point basis, it is much easier to get compensation in the NVICP system than in civil courts. For example, the claimant does not have to show that the vaccine was defective, which is difficult to show, given the thorough FDA (and many other regulatory agencies) thorough review of vaccine safety and effectiveness.

In addition, the Althen standard requires that the petitioner:

…show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.

In other words, if the petitioner can find an expert willing to testify and argue a theory that is logical and there is a temporal connection, a petitioner may win a case in which there is no scientific evidence supporting the claim that the vaccine can cause this harm. This is a very, very big break for petitioners.

To save some time, let me refer to something that Professor Dorit Rubinstein Reiss wrote regarding the difficulties in going through civil courts rather than the NVICP (the full article is a much more comprehensive review of the NVICP process):

“In a civil court, a petitioner claiming a vaccine injury is likely to claim a product defect, using either a negligence-like standard or a strict liability standard, depending on the claim. The plaintiff would have to show the following:

• That the product was defective in a relevant way – either a manufacturing defect (handled under strict liability), or a design defect or warning defect, both handled under what amounts to negligence principles. A plaintiff can also show negligence in relation to any of those defects.
• That the defect in the product actually caused the harm. With a pharmaceutical product leading to a medical injury, this will usually require (expensive) expert testimony.
• That the connection between the defect and the harm was not too remote, too unusual, or for other reasons, should be exempt from liability – this requirement is referred to, in a technical legal term, as proximate cause, though a recent trend has been to try and move to call it “being within the scope of liability”, to prevent confusion with the requirement of cause in fact.
• That there was legally cognizable harm.

The defendant would be able, in turn, to argue defenses against these claims, including, for example, a statute of limitations defense – in most states tort statutes of limitations run from two to three years. If suing the government, governmental immunity can limit a claim. Some jurisdictions apply the defenses of comparative negligence or assumption of risk to product liability claims as well, though not all do. Some jurisdictions cap certain kinds of damages.”

In general, suing for harm from vaccines in the NVICP is significantly easier (and cheaper, considering that the NVICP covers legal expenses for the plaintiff). Thus, down goes the first of those annoying vaccine court myths.

Vaccine court myths – manufacturers are immune

Other than the national security example mentioned above for certain vaccines like smallpox or COVID-19, this particular myth is untrue – vaccine manufacturers are not immune to lawsuits. Yes, for almost all of these lawsuits, the first step must be the NVICP, but that is not the whole story.

For example, there are ways to sue manufacturers like showing evidence that the pharmaceutical company engaged in fraud, produced a product that had a manufacturing defect, or was negligent. Each of these is difficult to prove, but if there were genuine evidence of any of those issues, then the manufacturer can be sued.

In addition, if a claim is denied by the Special Masters in the vaccine court, the case can be appealed, and if that fails the plaintiff can take it to civil court. However, if a case is denied in the NVICP, where it is demonstrably easier to prevail, it is unlikely that an attorney will want to pursue it in civil court.

Vaccine court myths – huge payouts

Here we go again with one of those vaccine court myths that seems to be a fundamental trope of the anti-vaccine activists. They claim that billions of dollars paid out by the NVICP is overwhelming proof that vaccines are unsafe. Of course, the facts are different, showing that the NVICP payouts are overwhelming evidence that vaccines are incredibly safe.

Let’s look at the facts – according to the latest report (1 November 2022) from the NVICP, 21,581 petitions were filed in the vaccine court to compensate for vaccine injuries since the beginning of the NVICP system in 1989. Of those claims, 9,254 were compensated for a total of US$4.911 billion.

The anti-vaccine crowd will scream “nearly 5 billion dollars paid out for vaccine injuries.” Yes, $5 billion seems like a lot, except that’s not the right way to look at this data. It has to be put into proper context.

During that time period of 1989 until today, around 9.0 billion doses of covered vaccines were distributed in the USA — using real math, this means just a bit over 0.00010% of vaccine doses given in the USA were compensated by the NVICP. Therefore, one of the easiest systems to establish and get compensated for “vaccine injuries,” one that heavily favors the plaintiffs, pays compensation for vaccine damages 1 in a million times. Moreover, those claims should be averaged over 9 billion doses, which results in only $0.55 in claims per vaccine dose.

One in a million chance of a significant adverse event, one that would deserve compensation, is much lower than just about any other medical procedure I could find. Based on this data alone, vaccinations are among the safest thing you can do in life. You’re in much more danger taking a shower or walking down the street.

And if you’re going to throw the $4.911 billion in claims in our faces, please look at it again from the totality of vaccine doses given — it’s infinitesimal. Vaccines are demonstrably safe.

Vaccine court myths – autism again

This is one of those vaccine court myths that is a bit more complicated, but it is still not supported by evidence.

Despite the fact that there is substantial and robust evidence that vaccines are not linked to autism, plaintiffs and their lawyers have kept trying to get the Special Masters to compensate for autism claims, which by the early 2000s had reached 5000 cases.

In 2002, the NVICP Special Masters, in consultation with a Petitioners Steering Committee whose members were chosen by plaintiffs who were claiming the autism-vaccine link, set up the Omnibus Autism Proceeding (OAP) to aggregate these cases. The group decided to examine six test cases that  made one or more of the following claims about the vaccines-autism link:

1. Claims that MMR vaccines and other thiomersal-containing vaccines can combine to cause autism.
2. Claims that center on vaccines containing thiomersal causing autism.
3. Claims that MMR vaccines alone (with no mention of thiomersal) can cause autism.

Three Special Masters examined the evidence for each of those claims. In 2009, they handed down their decisions. For each claim, the three Special Masters concluded that there was no evidence to support a vaccine-autism link.

Two of the decisions were appealed to the United States Court of Federal Claims and then to the Circuit of Appeals. In Cedillo vs the Secretary of Health and Human Services, the Court of Appeals for the Federal Circuit stated (pdf) that:

…we have carefully reviewed the decision of the Special Master and we find that it is rationally supported by the evidence, well-articulated, and reasonable. We therefore affirm the denial of the Cedillos’ petition for compensation.

In a paper written by Professor Reiss and Rachel Heap, they comment on this Appeals Court decision in no uncertain terms:

This is not a lukewarm or hesitant endorsement. The court is making is very clear that the Special Master’s decision deserves to be upheld. …it went through the Special Master’s decisions on the issues appealed and clearly endorsed the Special Master’s decision on each.

The OAP made a critical decision for thousands of cases involving the claim of a vaccine-autism link – they clearly stated that there was no link. They followed the scientific consensus and agreed that vaccines have nothing to do with autism. So, if you’re going to make any assertion that the NVICP has found in favor of a link between vaccines and autism, you’d be wrong.

And this decision was confirmed by a more recent ruling called the Mini-Omnibus Autism decision. This decision addresses the claims that DNA-containing vaccines cause autism. The Special Masters found the petitioners’ claims were not plausible. They did not meet the relatively low standard set by the NVICP – a standard that, to reiterate, is less demanding than the one a civil court would set.

The Hannah Poling decision

Despite the NVICP’s rejection of an autism link, the anti-vaxxers will bring up the so-called Hannah Poling ruling by the vaccine court.

Poling was born in 1999 and received five vaccines in one day in 2000 at the age of 19 months. This happened because she needed to catch up with the vaccine schedule – she had fallen behind on vaccinations as a result of a series of ear infections. Ten days after these vaccines, Hannah exhibited signs of autism spectrum disorder.

In 2002, the Poling family filed a case with the NVICP claiming a link between the five vaccines given in 2000 and Hannah’s development of autism. Hannah’s case was originally included with the nearly 5,000 NVICP cases included in the Omnibus Autism Proceedings but was pulled out for unknown reasons In 2008, the government conceded Hannah Poling’s vaccine injury case.

The decision explained that:

Respondent has conceded that petitioners are entitled to compensation due to the significant aggravation of Child Doc/77’s (Hannah Poling) pre-existing mitochondrial disorder based on an MMR vaccine Table presumptive injury of encephalopathy.

Of course, the anti-vaccine crowd jumped on this ruling to claim that the vaccine court ruled that vaccines cause autism.

Except, that’s not what happened. Numerous scientists stepped into the fray and said that the Hannah Poling case does not show that vaccines cause autism. In fact, the evidence points to a preexisting condition – the informative Orac wrote that he saw evidence that she had a mitochondrial disorder caused by a gene mutation.

Dr. Paul Offit, in an article published in the New England Journal of Medicine, explains what happened:

At the time, Hannah was interactive, playful, and communicative. Two days later, she was lethargic, irritable, and febrile. Ten days after vaccination, she developed a rash consistent with vaccine-induced varicella. Months later, with delays in neurologic and psychological development, Hannah was diagnosed with encephalopathy caused by a mitochondrial enzyme deficit. Hannah’s signs included problems with language, communication, and behavior — all features of autism spectrum disorder.

…although experts testifying on behalf of the Polings could reasonably argue that development of fever and a varicella-vaccine rash after the administration of nine vaccines was enough to stress a child with mitochondrial enzyme deficiency, Hannah had other immunologic challenges that were not related to vaccines. She had frequent episodes of fever and otitis media, eventually necessitating placement of bilateral polyethylene tubes.

Reiss and Heap also argue that the Hannah Poling case does not show a vaccine-autism link from a legal perspective. They wrote,

The government decided to concede that there was enough evidence that the vaccines aggravated an encephalopathy, a Table Injury, in the time required. To reiterate, the problem was already there, and the child was predisposed to regress, but because it was a Table Injury and it was possible that it was the vaccines that caused the aggravation, the presumption of causation came into play. The government was not willing to try to prove it was not the vaccines. The legal standard for compensation was met. This was an appropriate case to compensate a vaccine injury, but not strong proof of causation.

…the most recent word from NVICP is that the evidence does not support a causal connection between mitochondrial disease and vaccine injuries, and more particularly, does not support the claim that mitochondrial disorders make it more likely that vaccines will cause ASD in a child.

In other words, despite the claims of the anti-vaccine world that the Hannah Poling case confirms that the NVICP paid a claim that proves a link between vaccines and autism, the scientific evidence, and the legal decision both reject a vaccine-autism link in this case. The Hannah Poling case, though quite tragic, does not support the claim that vaccines caused autism.

Summary

No, the vaccine court is not a barrier to receiving fair compensation for vaccine adverse events. It is much easier to file and win an NVICP claim than it is in civil court.

No, the vaccine court does not shield manufacturers from lawsuits. If the plaintiff disagrees with an NVICP decision, they can file a lawsuit against a manufacturer in civil court. Plaintiffs can, under certain conditions, sue pharmaceutical companies for vaccine issues in civil courts.

Yes, nearly 5 billion dollars has been paid out to claimants in the vaccine court. But that ends up being around US$0.55 in payouts per vaccine dose during that time period. And that means around 1 in a million doses of vaccines end up in injury, an incredibly low number for a medical procedure.

And finally, no the vaccine court has never said that vaccines cause autism. In fact, they said there was no link like the scientific consensus has said.

Vaccine court myths are just myths. Facts show us otherwise.

Notes

1. The DPT vaccine, against diphtheria, pertussis (whooping cough), and tetanus contained what is called “whole-cell” pertussis. It was replaced, in 1996, by DTaP, for young children, or Tdap, for older children and adults, vaccines. The “ap” portion of the name refers to acellular pertussis, meaning only certain parts of the pertussis bacteria are used as an antigen. This change was meant to reduce some of the very rare side effects of the DPT vaccine. However, there is some pretty strong evidence that the original vaccine had better long-term effectiveness. There probably was no need to change the vaccine.