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Episode 8: Vaccine Safety 4 - The Vaccine Court and Adjudication of Autism Cases
- Heather McSharry, PhD
- Apr 29
- 19 min read
Updated: May 11
For informational purposes only, please discuss getting vaccinated with your physician. Feel free to show them this podcast.
Welcome back to my series devoted to helping parents sort through the propaganda and fear-mongering regarding vaccines. Episode 4 in the series clarifies what the vaccine court does and why it shows vaccines are safe.
THE VACCINE COURT
Parents who are just trying to do the best they can for their kids, are bombarded with anti-vax messages all the time. Anti-vaxxers argue that vaccines cause autism, despite the many studies that prove they do not (see my episode on vaccines and autism) including this very comprehensive study from 2019. Anti-vaxxers claim that scientists and physicians cover up these vaccine side effects so Big Pharma can profit (not true at all). And their coup de grâce? The very existence of the National Vaccine Injury Compensation Program. The fact that this program exists is their evidence that vaccine injuries are so common and so severe, that there must be an independent court to process the cases. Is that true? The answer is, no. Emphatically, no. How can we tell? We can determine the truth about that argument by understanding why VICP was created and the results of the claims brought to them over the last 35 years.
The National Vaccine Injury Compensation Program (VICP)
So let's look at where it started...with the whooping cough vaccine.
Let’s set the scene. It was the early 1980s. I was playing Donkey Kong on the Atari and riding my bike everywhere I could. Thanks to the pertussis vaccine, whooping cough cases in the U.S. had dropped by 150-fold. That’s not just a little dip — that’s a full-on public health triumph.
But, here's the twist: as the disease itself became rare, people started shifting their focus. Instead of worrying about whooping cough, they began to fear the vaccine.
Now, to be fair, the original whole-cell pertussis vaccine did have its issues. It was the triple DTP at the time, which stood for diphtheria, tetanus, and the whole-cell pertussis vaccine. It could cause side effects like swelling and fever, which are pretty normal, but sometimes it triggered more severe reactions — like prolonged crying fits, febrile seizures, and in rare cases, hypotonic–hyporesponsive episodes where kids would go limp for a short while.
And then, there were claims — which were later debunked — that the vaccine caused serious neurological problems. But by the time those claims were disproven, damage to public trust was already done.
It didn’t help that a TV documentary really amplified these fears, blaming the vaccine for a range of disabilities. That media coverage sparked the formation of a group called ‘Dissatisfied Parents Together’, which eventually became the National Vaccine Information Center — a group that, to this day, remains a major source of vaccine misinformation in the U.S. In fact, journalist Michael Specter described the NVIC as:
"... an organization that, based on its name, certainly sounds like a federal agency. Actually, it's just the opposite: the NVIC is the most powerful anti-vaccine organization in America, and its relationship with the U.S. government consists almost entirely of opposing federal efforts aimed at vaccinating children."
The panic had real consequences. Thousands of parents refused to vaccinate their children. Lawsuits poured in, vaccine makers started abandoning ship, and Congress had to pass the National Childhood Vaccine Injury Act just to keep vaccine production alive. Ironically, that law — intended to save public health — is now used by vaccine opponents as ‘proof’ that vaccines are dangerous. Go figure.
And it wasn’t just happening in the U.S. Countries like Sweden, the UK, and Japan also paused or reduced their pertussis vaccination programs during this time.
But while a lot of people were panicking, in Japan, one scientist named Yuji Sato was getting to work on a better solution. He believed the side effects were caused by all the extra junk — things like lipopolysaccharides and endotoxins — left over in the whole-cell vaccine.
So, he and his team developed a cleaner version. By 1974, they had created an 'acellular' pertussis vaccine, made mostly of two purified proteins: pertussis toxin and filamentous haemagglutinin. It was effective, with fewer side effects, and Japan approved it in 1981.
Other countries followed, tweaking the formula to make it even more effective. They bundled it back with diphtheria and tetanus vaccines, and that's how we got DTaP—again, diphtheria, and tetanus, but with acellular pertussis — the vaccine most kids get today in high-income countries. Meanwhile, many low- and middle-income countries still use the older, cheaper DTP, with whole-cell pertussis.
And that could have been the happy ending — except it wasn’t.
Because now, in countries using DTaP, we’re seeing whooping cough make a comeback. Cases peak every 2 to 5 years, just like they did before vaccines were widespread.
There are a few ideas about why this is happening but that isn't today's episode, we need to get back to the vaccine court.
As I mentioned, a bunch of claims were brought against vaccine manufacturers. Most were baseless, but juries awarded compensation to plaintiffs. Vaccine makers couldn't afford this, and why should they when vaccines were not their bread and butter, so they stopped production. This put all vaccines at risk. But we need vaccines.
Due to the DPT scare, and to keep manufacturers from abandoning vaccine production, the Vaccine Injury Compensation Program AKA, VICP, was established by Congress' 1986 National Childhood Vaccine Injury Act (NCVIA). Within VICP resides the “vaccine injury court” - AKA the Office of Special Masters - which is a division of the United States Court of Special Claims. If someone thought their child was harmed by a vaccine, they could present their case to this court. Don't let my pronunciation confuse you, it's VCIP not VICAP, which is the Violent Criminal Apprehension Program.
Compensation awarded by VICP
Another component of VICP is a trust fund to pay for compensation awards. An excise tax of 75 cents per administered vaccine, was implemented to finance the trust fund. To settle cases quickly and fairly, through VICP, cases are argued before a Special Master and adjudicated on a no-fault basis. In 80% of all cases brought since 2006, the parties settled. According to HHS, “Settlements are not an admission by the United States or the Secretary of Health and Human Services[…]that the vaccine caused the petitioner’s alleged injuries,” Let's reiterate. In these cases, after extensive review of the evidence, the HHS had not concluded that the vaccine caused the injury. So why settle? Many reasons, such as “a desire by both parties to minimize the time and expense associated with litigating a case to conclusion and a desire by both parties to resolve a case quickly and efficiently." If the petitioner disagrees with the court's ruling, they can appeal their case in civil court.
Now the thing is, in VICP — you don’t have to prove your case ‘beyond a reasonable doubt’ like you would in criminal court. Nope. The bar is much lower. All you need is a ‘preponderance of the evidence.’ Just 51% certainty. That’s it.
And here's something most people don't realize: in vaccine court, that standard is applied even more generously than in a typical civil case. Which, in practice, gives the benefit of the doubt to the person filing the claim.
But — and this is important — most cases don’t even get that far. About 80% of the time, the two sides just settle. So the person making the claim gets compensated without anyone actually deciding whether the vaccine caused the injury or not.
But again, the beauty — and some would say, the flaw — of the VICP is that it’s a no-fault system. You don’t need concrete proof. You don’t have to show cause and effect. If it’s plausible? You can still get compensated. And it’s those edge cases — the rare and serious ones — that drive up the average payouts and attract the most attention.
Please be advised, this messaging from the Secretary of Health and Human Services is likely to change under the hardcore antivax ideology of RFK. Make no mistake, this does not change the facts and that the messaging above is true and accurate regardless of RFK's lies.
Speaking of which, what do the antivaxxers say about the vaccine court?
Anti-vax message: The Government hides the vaccine court!
One website, typical of the anti-vax movement, reads, “It is obvious that the government does not want to publicize the existence of the [court], because the more Americans learn that there are vaccine injuries and deaths … the more they may start to question the safety of vaccines.”
TRUTH: Okay. The above anti-vax message is completely false. The law was well-publicized when it passed. There is a very public website for it that explains the Court, and provides the names and contact information of lawyers in all 50 states. It also helps you file a claim. No one is hiding the existence of the court. But that is not what anti-vaxxers want you to think. The anti-vax agenda is to convince you that the government is hiding this information.
Anti-vax message: Existence of VICP is proof that vaccine injuries are so common & severe, that we need an independent court to process the cases.
Since 1988, more than 16,000 claims have resulted in $3.18 billion awarded to families alleging vaccine injury. Anti-vaxxers point this out and say, see? We are right, vaccines need to go, and the existence of the court itself is proof that we are right and everyone else is lying on behalf of big pharma.
TRUTH: Anti-vax interpretation of the numbers is completely incorrect. In reality, the numbers prove that vaccines are safe. Let's examine the facts so we can understand why that is.
Vaccines Administered Vs Claims Adjudicated by VICP:
From 2006 to 2017 over 3.4 billion doses of covered vaccines were distributed in the U.S. During that time, 6,571 petitions were adjudicated by the Court, with compensation awarded to 4,525 of those. Thus: One individual was compensated for every one million doses of vaccine administered. One individual was compensated for every one million doses of vaccine administered. This means vaccines are incredibly safe.
SIDEBAR: Let's take a closer look at that one in a million vaccine injury claim to some other really common childhood medicine. One in a million. To be clear, that is not the risk of vaccine injury, that is how often vaccine claims are settled without establishing that a vaccine caused an injury. So the risk of proven vaccine injury is even lower. But we'll use 1 in a million here just to make it easy. Now, let's look at how that risk compares to the risk of a significant injury from other drugs that parents give their kids with confidence. Let's take Acetaminophen (e.g, Tylenol) for example. A 2013 review reads:
"Acetaminophen is the over-the-counter (OTC) antipyretic and analgesic medication most commonly used in children." They go on to say:
"Acetaminophen monographs might surprise clinicians and parents alike, as many consider the drug safe to use and provide parents with the quote within a quote, “feeling of mastery.” I can confirm this feeling of mastery as I have and still do vanquish my child's fevers with acetaminophen. Ok, so for acetaminophen, numerous potential adverse effects are mentioned in guidelines for its labeling. However, most severe adverse effects listed are really rare. In one large study from Boston, Mass, children younger than 2 years of age with fever were randomized to receive acetaminophen (12 mg/kg) or ibuprofen (e.g., Advil) and were found to have a low rate of adverse effects. Among the more than 9000 children who received acetaminophen, the absolute risk of hospitalization for asthma or bronchiolitis was 260 children per 100,000, and the risk of hospitalization for vomiting or gastritis was 24 children per 100,000." Other studies corroborate these findings. The Boston study is behind a paywall so here you go:
OK, So for acetaminophen, the risk is 260 per 100,000 and 24 per 100,000 and we consider that level of risk to be RARE. Now let's turn those really rare side effect numbers into something we can compare with the one in a million vaccine injury claim.
The risk of hospitalization for asthma or bronchiolitis was 260 children per 100,000, so what is that if we make it out of one million? Let's do the math.
260/100,000 = X/1,000,000
X=2600
2600 out of one million compared to 1 out of 1 million. And yet we don't blink an eye over Tylenol.
And the risk of hospitalization for vomiting or gastritis with acetaminophen? 24 children per 100,000. SO:
24/100,000=X/1,000,000
X=240
240 out of one million. Again the risk of severe adverse events after acetaminophen is significantly more than the risk after vaccines.
But you don't see parents marching in the streets to get Tylenol banned or filing lawsuits against the manufacturer. Why? Because there is no anti-acetaminophen movement using propaganda to scare parents into not using it. The risks ARE RARE for acetaminophen. And we need it! It helps our children. It prevents febrile seizures and other risks that illness and fevers bring. Not to mention it makes kids feel better and let's parents and kids get some rest.
Pro tip: Vaccinated children need drugs like acetaminophen less often. Bonus!
BOTTOM LINE - The Vaccine Court Decisions demonstrate unequivocally that vaccines are incredibly safe.
So next time you hear someone say, ‘The vaccine court paid out millions! That must mean vaccines are dangerous!’ — remember the numbers. And remember the system was built to err on the side of generosity to families, not because the science says vaccines are unsafe.
So What Are the Real Side Effect Risks of Vaccines?
The truth is, that most vaccines side-effects are those we've all heard of. They are all listed on the flyer the doctor gives you before your child is vaccinated and they give you a copy to take home when you leave the doctor's office. So they are not being covered up. No one is hiding this. Just like the possible adverse reactions to Tylenol are right there on the package. If you check the CDCs website - which provides info on all ingredients in the vaccine etc, right there for us to see - I investigated it all when I was pregnant and provide package inserts for the most common MMR vaccines in the episode on measles. So, the common side effects of that and all vaccines are:
Sore arm from the shot (Ouch. This one hurts cuz it goes into back of the upper arm.)
Fever
Mild rash
Temporary pain and stiffness in the joints, mostly in teenage or adult women who did not already have immunity to the rubella component of the vaccine
How about rare and serious side effects?
Serious side effects are rare, but may include seizure or life-threatening allergic reaction. However, when adverse health events coincide with vaccination, people tend to blame the vaccine. The Vaccine Adverse Events Reporting Systems (VAERS) is where people can report problems after vaccination. With zero evidence to back up their claims by the way. Anyone can report anything at any time. From January 1991 to December 2001, VAERS received 128,717 case reports describing adverse events after immunization, 14.2% of which were serious including deaths and life-threatening illness. Follow-up investigation showed that these serious events were not in fact caused by vaccines.
Now, VAERS data is publicly available, but please take their disclaimer seriously: "VAERS reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Reports to VAERS can also be biased. As a result, there are limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind."
Pro Tip: Incidence of serious adverse outcomes is significantly higher with infectious diseases than with vaccines.
And because parents hear so much about possible vaccine injuries, I have a vaccine safety series here that includes an episode on autism. I am also writing more episodes on all severe adverse outcomes that parents might hear about and be concerned over including Guillain-Barré Syndrome as well as severe vaccine injuries caused by vaccines not approved in the US and that have been withdrawn from the international market like Pandemrix and Dengvaxia. Stay tuned for those.
Now I want to circle back to something. My recent MMR shots hurt my arm and I had no other side effects. My son has also had all his vaccines on schedule and has had no adverse reactions. In fact everyone I know personally has safely been vaccinated. You know who else has been safely vaccinated? RFK and his kids. Yep. He has a financial stake in the antivax movement. So while he's telling the world how scared you should be of vaccines, and how you should buy his snake oil to treat measles instead of vaccinating your kids, or how proud you should be that you let your child die rather than get them vaccinated, he makes sure he and his kids are vaccinated. He's a piece of shit. An ignorant, lying, piece of shit with zero scientific or medical training who is getting people killed.
So back to the vaccine court.
Now that we know the real reason behind establishment of VICP, let's look at the cases that have been adjudicated. More specifically, let's look at autism cases. (links are to court documents)
Omnibus Autism Proceeding: The Special Masters created the Omnibus Autism Proceeding (“OAP”) to determine the relationship, if any, between vaccines and autistic spectrum disorders. They chose six test cases, that, in the petitioners’ judgment, presented the clearest and strongest arguments for the proposition that vaccines had caused autism, representing two separate theories of causation 1: that measles, mumps, and rubella (MMR) vaccines and thimerosal containing vaccines can combine to cause autism; 2: that thimerosal-containing vaccines, by themselves, can cause autism; A third theory - that MMR vaccine, by itself, can cause autism was later abandoned due to extensive evidence to the contrary, and so was not adjudicated in test cases by OAP.
Now, one of the most controversial — and misunderstood — cases in the history of vaccine injury claims is the story of a little girl named Hannah Poling, and how her case ignited a national debate about vaccines, autism, and the system built to protect both public health and families and I want to talk about her case first.
So here’s what happened.
Hannah was a healthy, typically developing child until she was about 18 months old. Around that time, she received a series of routine vaccinations — the kind most kids get. But after those shots, her parents noticed a shift. She started to regress. She lost speech skills, became withdrawn, and developed symptoms that looked a lot like autism.
Her family filed a claim with VICP.
Now, normally, these proceedings are confidential. But word got out that the government had quietly agreed to compensate Hannah’s family. And that set off a firestorm.
Because to some, this looked like the government was finally admitting that vaccines can cause autism. But that's a grave misunderstanding of what happened.
At a press conference on the steps of the federal courthouse in Atlanta, an advocate from the antivax Autism United said exactly that: “For the first time, the court has conceded that vaccines can cause autism.”
But that’s not what the ruling actually said.
What the government acknowledged was that Hannah had a rare, underlying mitochondrial disorder — a condition in her cells that affected how her body produced energy. And the theory was that vaccines might have triggered or worsened that pre-existing condition, which then led to her autistic-like symptoms.
So to be clear: the court didn’t say vaccines caused autism. It said they may have aggravated a hidden condition that led to a complex medical outcome that included symptoms like autism.
Now, scientists and public health officials were quick to push back on how this was being interpreted. Julie Gerberding, who led the CDC at the time, said it bluntly: “The government has made absolutely no statement indicating that vaccines are a cause of autism.”
And experts in mitochondrial disease — including the head of the United Mitochondrial Disease Foundation — agreed that while a trigger like a vaccine could make the condition worse, there’s no evidence that vaccines actually cause mitochondrial disorders. Or autism.
Still, for a lot of parents, that wasn’t convincing.
And many focused on thimerosal, a mercury-based preservative that was once used in vaccines. However, they got this wrong too! Thimerosal contains ethyl mercury. NOT methyl mercury. Methyl mercury is the mercury in fish. The bad kind. The higher up on the food chain you are, the more you get kind. And since 2001 pediatric vaccines have NOT contained thimerosal. And yet... no reduction in autism. More evidence debunking the autism-vaccine myth.
OK, so back to Hannah. Hannah’s case was resolved privately. There was no formal hearing in her case. But the system still adjudicated those six test cases I mentioned. So let's talk about how those turned out.
In 2007, three Special Masters heard three test cases to represent the first theory of causation: that measles, mumps, and rubella (MMR) vaccines and thimerosal containing vaccines can combine to cause autism.
The Special Masters’ decisions in the three test cases, issued on February 12, 2009, rejected the petitioners’ causation theories. All three of the Theory 1 test cases were appealed (to court of Federal Claims & U.S. Court of Appeals for the Federal Circuit). The Special Masters’ decisions were upheld each time.
From George L. Hastings, Jr., Special Master, in the case of Michelle Cedillo, No. 98-916V:
"I concluded that the evidence was overwhelmingly contrary to the petitioners’ contentions... Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems."
From Denise K. Vowell, Special Master, in the case of Colten Snyder, No. 01-162V:
"After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were speculative and unpersuasive. Respondent’s experts were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention."
From Patricia E. Campbell-Smith, Special Master, in the case of William Yates Hazlehurst, No. 03-654V:
“[P]etitioners’ experts tended to assign greater weight to speculative conclusions offered by the investigators involved in the studies than did the investigators themselves. Petitioners’ experts also urged reliance on a few carefully selected sentences from particular articles which, when considered in the proper context of the referenced articles, did not support the propositions advanced by the witnesses. Moreover, because petitioners’ experts relied on a number of scientifically flawed or unreliable articles for several important aspects of their causation theory, their testimony on those aspects of their offered theory could not be credited as sound or reliable. Finally, petitioners’ experts made several key acknowledgments during testimony that rendered their proposed theory of vaccine causation much less than likely.”
The full OAP record encompasses tens of thousands of pages of medical literature, more than four thousand pages of hearing testimony, and fifty expert reports. The committee ultimately concluded that a causal relationship between MMR vaccinations and autism did not exist. The committee based its conclusion on four factors:
1) A consistent body of epidemiological evidence shows no association, at a population level, between MMR vaccine and autism spectrum disorder.
2) The original case series of children with autism spectrum disorder and bowel symptoms and other available case reports are uninformative with respect to causality. In addition, they were ALL linked to Andrew Wakefield's fraudulent Unigenetics data and none of the studies indicating the presence of measles virus in autistic children had been successfully replicated by an accredited laboratory independent of Dr. Wakefield or Unigenetics.
3) Biologic models linking MMR vaccine and ASD are fragmentary.
4) There is no relevant animal model linking MMR vaccine and autism spectrum disorder.
In 2007, three Special Masters also heard three test cases to represent the Second theory of causation - that thimerosal-containing vaccines, by themselves, can cause autism. The three cases were:
From Patricia Campbell-Smith, Special Master, in the case of William P. Mead, No. 03-215V
“The underpinnings for the opinions of petitioners’ experts are scientifically flawed, and in the absence of a sound basis for the offered opinions of causation, those opinions cannot be credited....Based on the developed record in this proceeding, the undersigned is unpersuaded that the thimerosal content of the prescribed childhood vaccines contributes to the development of autism as petitioners have proposed under this theory of general causation.”
From George L. Hastings, Jr., Special Master, in the case of Jordan King, No. 03-584V
“...I conclude that the evidence is overwhelmingly contrary to the petitioners’ contentions. The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning the key points. The numerous medical studies concerning the issue of whether thimerosal causes autism, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering all of the evidence, I find that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to the causation of autism. I further conclude that while Jordan King has tragically suffered from autism, the petitioners have also failed to demonstrate that his vaccinations played any role at all in causing that condition.”
From Denise K. Vowell, Special Master, in the case of Colin R. Dwyer, No. 03-1202V:
"To prevail, they must show that the exquisitely small amounts of mercury in TCVs that reach the brain can produce devastating effects that far larger amounts experienced prenatally or postnatally from other sources do not. In order to account for this dichotomy, they posit a group of children hypersensitive to mercury’s effects, but the only evidence that these children are unusually sensitive is the fact of their ASD [autism spectrum disorder] itself. In an effort to render irrelevant the numerous epidemiological studies of ASD and TCVs that show no connection between the two, they contend that their children have a form of ASD involving regression that differs from all other forms biologically and behaviorally. World-class experts in the field testified that the distinctions they drew between forms of ASD were artificial, and that they had never heard of the ‘clearly regressive’ form of autism about which the petitioners’ epidemiologist testified. Finally, the causal mechanism petitioners proposed would produce, not ASD, but neuronal death, and eventually patient death as well. The witnesses setting forth this improbable sequence of cause and effect were outclassed in every respect by the impressive assembly of true experts in their respective fields who testified on behalf of respondent."
A more recent case, in 2018, follows the same logic and reason in adjudicating vaccine/autism cases. In Motuzyuk vs. SHHS, Special Master Corcoran dismissed the case for lacking reasonable basis, but even so included the following in the judgement:
"But the question of the propensity of vaccines to cause autism has been largely foreclosed in the Vaccine Program by a host of extremely well-reasoned, carefully-considered cases decided over the past twelve years. There is no justification in this case for expending the time and money for yet another expert on this topic given the extremely low odds that said expert could offer an opinion based on new science more persuasive than all the expert opinions on the topic that have already been rejected over and over again. See Hardy v. Secy of Health & Human Servs., No. 08-108V, 2015 WL 7732603, at *4–5 (Fed. Cl. Spec. Mstr. Nov. 3, 2015) And with that judgement referenced eleven autism claims unsuccessfully tried, plus six that were rejected (over the petitioners’ objections) without trial.
The bottom line: is that the existence of the vaccine court and its payout for claims with an incredibly low bar, does not in fact mean that the government and all the scientists worldwide secretly think vaccines cause autism and are hiding it and paying people to keep quiet. What this story reminds us is that science and public health are always walking a tightrope — balancing compassion for families, while still protecting the broader community from preventable diseases. It’s complicated, it’s emotional, and it’s incredibly high-stakes.
But there's a real risk of people misunderstanding cases settled through the vaccine court and the antivax movement has only gotten more effective at peddling their lies. And here we are. Antivaxxers are making us sick again and now they are being led by RFK, whose ascendancy to the ultimate antivax throne is putting Americans' access to vaccines at risk. We need to collectively stand up for science and the truth about vaccines. Spread knowledge, not diseases. Again I will say, vaccines do not cause autism or any other developmental disorder, vaccines cause adults.
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