in state court for vaccine injury, as long as the claim is not of design defect, and as long as they have already gone through Vaccine Court
So it certainly isn’t true that “under no circumstance may you sue a vaccine manufacturer.”
What’s the benefit of going through Vaccine Court, “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions?”
For one thing, the majority of compensated claims in Vaccine Court are settled claims, in which “cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury.”
It is likely that at least some of those claims wouldn’t win if they weren’t in Vaccine Court, where:
causation is presumed (you automatically win) if you are claiming a table injury
the rules for evidence are relaxed and expert testimony does not necessarily have to meet the strict requirements of the Daubert standard
petitioners must meet a fairly lenient standard to win, the regular standard of proof for a civil trial (more likely than not), but only have to provide a plausible theory for vaccine injury. Instead of providing scientific evidence or proving causation, they simply have to provide a theory that “is ‘logical’ and legally probable, not medically or scientifically certain.”
you don’t have to show that the vaccine was defective to make your case
Another benefit of Vaccine Court? All lawyer fees are paid, whether you win or lose, and lawyers do not get part of the award if you win. In traditional court, lawyers might get up to thirty-three percent of your award.
What to Know About Vaccine Manufacturer Liability and Vaccine Court
Although they must usually go through Vaccine Court first, folks can still sue vaccine manufacturers in some cases.
More on Vaccine Manufacturer Liability and Vaccine Court
Hannah Poling is autistic and her family was compensated by the Vaccine Court. But she wasn’t compensated for autism.
“Because she had an existing encephalopathy (presumably on the basis of a mitochondrial enzyme defect) and because worsening of an existing encephalopathy following measles-containing vaccine is a compensible injury, Hannah Poling was compensated.”
Why was Hannah Poling compensated?
Hannah Poling was compensated because she had a table injury.
Has the Vaccine Court Compensated over 70 Families for Autism?
Those were the test cases that represented three different theories of how vaccines could possibly be associated with autism. None of them were upheld by the Vaccine Court and none of the families were compensated.
“The devil is in the details. You can call autism many different things and it looks very much differently to different folks. But at the end of the day, the Vaccine Court has awarded over 70 families that their children now have autism and these children developed encephalitis, which is brain inflammation, that turned into autism. 70 families. And your viewers can google Hannah Poling and Baxter Bailey. Those are two of the most popular cases. And the U.S. government said to them, your child received autism because of this. I mean, they were awarded. So, it’s in the books.”
Liza Longoria Greve on KOCO News 5
So how could anyone be saying that over 70 families of autistic children have been compensated by the Vaccine Court?
I guess folks can say whatever they want, especially when the media doesn’t understand the idea of false balance and gives them a platform, after all, that’s how you explain much of propaganda of the anti-vaccine movement.
Again, folks can say whatever they want, but this is actually a little different from what they usually claim, that autism is encephalitis.
Of course, it isn’t.
70 Families? Google It
So what happens if you ‘google it‘ and actually research Liza Longoria Greve’s claim?
We already know about Hannah Poling… Again, she has a mitochondrial disorder and autism and she was compensated because it was thought that she had an adverse event to getting vaccinated because of her mitochondrial disorder.
And Baxter Bailey? You don’t find anything if you look for Baxter Bailey, but you will eventually find information about Bailey Banks, who was compensated for (acute disseminated encephalomyelitis) ADEM, which led to Pervasive Developmental Delay (PDD). He wasn’t compensated for autism though.
What about the other families she is talking about?
A little more googling and you find that she is likely talking about an article, Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury, that was published in the Pace Environmental Law Review in 2011 by Mary Holland, in which she reports finding “eighty-three cases of autism among those compensated for vaccine-induced brain damage.”
Since then, many of those children have been found to have Dravet syndrome, which is not a vaccine injury or vaccine induced disease. Dravet syndrome includes children who develop severe, fever-related seizures before their first birthday.
First described by Dr. Charlotte Dravet in 1978, using mutation screening of the SCN1A gene, in 2006, Dr. Samuel Berkovic found that many adults had Dravet syndrome too.
“We present here the cases of 5 children who presented for epilepsy care with presumed parental diagnoses of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome.”
Reyes et al on Alleged cases of vaccine encephalopathy rediagnosed years later as Dravet syndrome
Others soon replicated Berkovic’s work and found other children with the SCN1A mutation that causes Dravet syndrome. These children had hard to control seizures, developmental delays, and autism-like characteristics and included some with an “alleged vaccine encephalopathy.”
That they didn’t have a vaccine injury wasn’t a surprise to many people, as many of the early reports about the DPT vaccine and seizures were wrong. In 1973, Dr. John Wilson took to the media to scare parents because he had “seen too many children in whom there has been a very close association between a severe illness, with fits, unconsciousness, often focal neurological signs, and inoculation.” What followed was a drop in DPT vaccinations in many countries and vaccine lawsuits, even though his study was later found to be seriously flawed, with most having no link to the DPT vaccine.
“Although Dravet syndrome is a rare genetic epilepsy syndrome, 2.5% of reported seizures following vaccinations in the first year of life in our cohort occurred in children with this disorder.”
Verbeek on Prevalence of SCN1A-Related Dravet Syndrome among Children Reported with Seizures following Vaccination: A Population-Based Ten-Year Cohort Study
What’s the association between Dravet syndrome and vaccines?
Since infants with Dravet syndrome have febrile seizures, any fever can trigger those seizures. Of course, vaccines can cause fever. And so infants with Dravet syndrome who get a fever after their vaccines can have seizures. Even without getting vaccines, they will eventually have seizures, so skipping or delaying vaccines isn’t a good idea for these kids.
There Is a New Treatment for an Old Vaccine Induced Disease
Have you ever heard of Dravet syndrome?
Even though Dravet syndrome is now known to be at least twice as common as once thought – at about 1 in 15,000 children, many parents have still never heard of it.
“Multiple prolonged febrile seizures in an otherwise well child, usually starting by 8 months of age, are the early clinical hallmarks of Dravet syndrome. Other typical features of this devastating disorder include refractory and multiple seizure types after 12 months of age, including partial, myoclonic, atonic, and absence seizures, and developmental delays and motor impairment such as ataxia and spasticity.”
Wu et al on the Incidence of Dravet Syndrome in a US Population
If you have been locked into the idea that your child was vaccine injured or vaccine damaged after the DPT vaccine, then you have likely not have heard of Dravet syndrome.
Without a diagnosis, Cossolotto said, she would probably still believe — erroneously — that the DPT shot caused Michaela’s illness. “I understand this is a genetic condition,” she said. “Having an answer does make a difference.”
Medical mystery: Seizures strike baby after routine vaccine
That’s unfortunate, as there is a new treatment for Dravet syndrome that is showing a lot of promise. Although not a cure by any means, use of cannabidiol (CBD) oral solution has been shown to reduce seizures in children with Dravet syndrome.
And no, getting a prescription for cannabidiol oral solution from a neurologist is not the same as buying CBD oil, hemp oil, or CBD hemp oil on the internet. While they are all free of THC, you have no idea of the real concentration of CBD when you buy these substances on the internet. Also, hemp oil doesn’t even contain CBD, so won’t control seizures or do much of anything else.
“Previously, many children with severe epilepsy and intellectual disability did not receive a specific diagnosis; there was only limited ability to take the diagnosis further. With advances in clinical epileptology, genetics, and neuroimaging, specific forms of severe epilepsy that lead to progressive intellectual deterioration can be identified.”
Samuel Berkovic, MD on Cannabinoids for Epilepsy — Real Data, at Last
How would you know if your child has Dravet syndrome? Mutation screening of the SCN1A gene, something that is now routinely done for infants with repeated febrile seizures.
Is mutation screening of the SCN1A gene to test for Dravet syndrome something your MAPS doctor would suggest for your older child?
What to Know About Getting Diagnosed and Treating Dravet Syndrome
Children with Dravet syndrome were once misdiagnosed as having a vaccine encephalopathy and may have some new hope in having resistant seizures treated with cannabidiol oral solution.
More on Getting Diagnosed and Treating Dravet Syndrome
People with Guillain-Barré syndrome develop the rapid onset of muscle weakness and then paralysis. They may also have numbness and a loss of reflexes.
Unlike some other conditions that cause weakness and paralysis, GBS is a symmetrical, ascending paralysis – it starts in your toes and fingers and moves up your legs and arms.
What Causes Guillain-Barré Syndrome?
GBS is an autoimmune disorder and often starts after a viral or bacterial infection, especially one that causes diarrhea or a respiratory illness.
One of the biggest risk factors is a previous Campylobacter jejuni infection, that is often linked to drinking raw milk, eating undercooked food, drinking untreated water, or from contact with the pet feces.
In less half of cases, no specific cause is found.
Fortunately, although progress can be slow, many people with GBS recover.
“On very rare occasions, they may develop GBS in the days or weeks after getting a vaccination.”
CDC on Guillain-Barré syndrome and Flu Vaccine
It is not common though.
For example, the increased risk of GBS after getting a flu vaccine is thought to be on the order of about one in a million – in adults.
Flu vaccines have not been shown to cause GBS in children.
“The risk of GBS is 4–7 times higher after influenza infection than after influenza vaccine. The risk of getting GBS after influenza vaccine is rare enough that it cannot be accurately measured, but a risk as high as one case of GBS per 1 million doses of flu vaccine cannot be reliably excluded.”
Poland et al on Influenza vaccine, Guillain–Barré syndrome, and chasing zero
It is also important to keep in mind that you are far more likely to get GBS after a natural flu infection than after the vaccine, plus the flu vaccine has many other benefits.
What about other vaccines?
“In this large retrospective study, we did not find evidence of an increased risk of GBS following vaccinations of any kind, including influenza vaccination.”
Baxter et al on Lack of association of Guillain-Barré syndrome with vaccinations
No other vaccines that are currently being used routinely have been associated with Guillain-Barré syndrome.
In fact, many studies do not even find an association between GBS and the flu vaccine.
What to Know About Guillain-Barré Syndrome and Vaccines
Guillain-Barré Syndrome may be associated with the flu vaccine in adults in about 1 in a million cases, but does not occur with any other vaccines, and occurs far more commonly after a natural flu infection.
It is mostly because they think that anything bad that happens after someone is vaccinated, even if it is weeks or months later, must have been caused by the vaccine.
“Differentiation between coincidence and causality is of utmost importance in this respect. This is not always easy, especially when an event is rare and background rates are not available.”
Heininger on A risk-benefit analysis of vaccination
Of course, this discounts that fact that most people have a basic risk, often called the background rate, for developing most of these very same conditions, and they can just coincide with getting vaccinated.
Put more simply, the “reaction” would have happened whether or not they had been vaccinated.
“…when a number of well-controlled studies were conducted during the 1980s, the investigators found, nearly unanimously, that the number of SIDS deaths temporally associated with DTP vaccination was within the range expected to occur by chance. In other words, the SIDS deaths would have occurred even if no vaccinations had been given.”
WHO on Six Common Misconceptions About Immunization
That doesn’t mean that everything automatically gets blamed on coincidence though.
Is It a Vaccine Reaction?
When trying to determine if a child has had a vaccine reaction, experts typically go through a series of questions, looking at the evidence for and against :
How soon after the vaccine was given did the reaction occur? Was it minutes, hours, days, weeks, months, or years later?
Is there any evidence that something else could have caused the reaction?
Is there a known causal relation between the reaction and the vaccine?
Is there evidence that the vaccine does not have a causal association with the reaction?
Do any lab tests support the idea that it was a vaccine reaction?
Why is it important to consider these and other questions?
Because most of us are very good at jumping to conclusions, are quick to place blame, and like to know the reasons for why things happen.
We don’t like to think that things are just caused by coincidence.
Post hoc ergo propter hoc (after this, therefore, because of this).
We are especially good at linking events and often automatically assume that one thing caused another simply because it occurred afterwards.
It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.
Dr Samuel Johnson
But we also know that correlation does not imply causation. And because of the great benefits of vaccines, it is important to find strong evidence for a correlation before we blame vaccines for a reaction.
Too often though, the opposite happens. Despite strong evidence against a correlation, parents and some pediatricians still blame vaccines for many things, from SIDS and encephalitis to autism.
Background Rates vs Vaccine Reactions
Although anti-vaccine folks are always calling for vaccinated vs unvaccinated studies to further prove that vaccines are indeed safe, much of that work is already done by looking at the observed rate of possible reactions and comparing them to the background rate of reactions and conditions.
We often know how many people are expected to develop certain conditions, from seizures and type 1 diabetes mellitus to acute transverse myelitis and juvenile and rheumatoid arthritis.
“On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.”
Black et al on Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines
Intussusception is a good example of this.
This might surprise some folks, but we diagnosed and treated kids with intussusception well before the first rotavirus vaccines were ever introduced. And then, it was only after the risk of intussusception after vaccination exceeded the background rate that experts were able to determine that there was an issue.
“Knowledge of the background incidence rates of possible adverse events is a crucial part of assessing possible vaccine safety concerns. It allows for a rapid observed vs expected analysis and helps to distinguish legitimate safety concerns from events that are temporally associated with but not necessarily caused by vaccination.”
Gadroen et al on Baseline incidence of intussusception in early childhood before rotavirus vaccine introduction, the Netherlands, January 2008 to December 2012
Fortunately, studies have never found an increased risk above the background rate for SIDS, non-febrile seizures, and other things that anti-vaccine folks often blame on vaccines. So when these things happen on the same day or one or two days after getting vaccinated, it almost certainly truly is a coincidence. It would have happened even if your child had not been vaccinated, just like we see these things happen in the days before a child was due to get their vaccines.
For example, using background incidence rates in Danish children, one study found that if you vaccinated a million children with a new flu vaccine, you could expect that naturally, after seven days, you would see:
facial nerve palsy – one case
seizures – 36 cases
multiple sclerosis – one case
type 1 diabetes – three cases
juvenile and rheumatoid arthritis – three cases
After six weeks, those numbers of course go up. In addition to 4 kids developing MS, 20 develop diabetes, 19 develop arthritis, and 218 have seizures, and there would have been at least two deaths of unknown cause.
Would you blame the flu shot for these things?
What flu shot?
This was a “hypothetical vaccine cohort” that used 30 years of data from the Danish healthcare system to figure out background rates of each condition.
“In addition, the expected number of deaths in Japan following an estimated 15 million doses of H1N1 vaccine administered would be >8000 deaths during the 20 days following vaccination, based on the crude mortality rate.”
McCarthy et al on Mortality Rates and Cause-of-Death Patterns in a Vaccinated Population
Looking at background rates is especially helpful when folks report about vaccine deaths.
Using the Japan example that McCarthy studied, if they had looked at background rates, then all of a sudden, the 107 deaths they found after 15 million doses of H1N1 vaccine were given in 2009 would not have been so alarming. Background rates would have predicted a much, much higher number of deaths to naturally occur in that time period simply based on crude mortality rates.
Vaccines are safe and many of the things that folks think are vaccine reactions can be explained by looking at the background rates for these conditions and understanding that they would have happened anyway.
Just about any side effect after a vaccine can be scary for parents.
What if your child suddenly became limp, wasn’t responsive, and was pale?
That would be scary for any parent.
What Are Hypotonic-Hyporesponsive Episodes?
But that’s just what can happen when a child has a hypotonic–hyporesponsive episode (HHE).
“A hypotonic-hyporesponsive episode (HHE) is the sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis that occurs within 48 hours after childhood immunizations.”
DuVernoy et al on Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998
These types of episodes were once thought to happen once for every 1,750 DTP vaccines given.
Fortunately, although they certainly do sound scary, the episodes stop on their own and don’t cause any permanent harm.
Hypotonic-hyporesponsive episodes were even removed as table injuries after DTP back in 1995. It is not that HHE can’t occur after DTP, DTaP, or other vaccines, but rather that HHE doesn’t then cause any permanent neurological damage to the child.
And it is rare for kids to have a second episode, so they can continue to get vaccinated. HHE is not a good reason to skip or delay all of your child’s vaccines. While not a contraindication to getting vaccinated, having an episode of HHE “within 48 hours after receiving a previous dose of DTP/DTaP,” is listed as a precaution to getting another dose of DTaP or Tdap though.
“In general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk for an adverse reaction.”
CDC on Vaccine Contraindications and Precautions
Also, HHE has become even more rare since we switched to using DTaP, instead of the older DTP vaccine. So being worried about HHE is definitely not a good reason to skip or delay any vaccines.
What to Know About Hypotonic-Hyporesponsive Episodes
Hypotonic-hyporesponsive episodes were more common after the older DTP vaccines, but still didn’t cause any long term problems and aren’t a good reason to skip or delay your child’s vaccines.
It is not uncommon to hear about parents having ‘panic attacks’ over the idea of vaccinating their kids.
“…many parents are inundated with horror stories of vaccine dangers, all designed to eat away at them emotionally while the medical and scientific communities have mounted their characteristic response by sharing the facts, the data, and all of the reliable peer-reviewed and well-cited research to show that vaccines are safe and effective.”
Federman on Understanding Vaccines: A Public Imperative
“…recognizes the importance of examples—testimonials and stories—that are the lifeblood of vaccine-hesitant beliefs.”
Nathan Rodriguez on Vaccine-Hesitant Justifications
Vaccine injury stories aren’t new though.
These types of anecdotal stories were very popular when folks used to think that the DPT vaccine was causing a lot of side effects. It wasn’t though. And it was soon proven that the DPT vaccine didn’t cause SIDS, encephalitis, non-febrile seizures, and many other things it was supposed to have caused.
“Anecdotes – about a new miracle cure, a drug that is not being made available on the NHS, or the side effects of treatment, or some environmental hazard – sell product. Data, on the other hand, which take us towards the truth about these things, are less popular. Anecdotes, however many times they are multiplied, do not point the way to reliable knowledge. As the aphorism says, “The plural of anecdote is not data”.”
Raymond Tallis on Anecdotes, data and the curse of the media case study.
That anecdotes “sell” better than data may be one reason why you see them so often on anti-vaccine websites. Another is that they simply don’t have any good data to use as evidence!
Are Vaccine Injury Stories True?
Vaccines are not 100% safe, so there is no doubt that some vaccine injury stories are true.
There is also no doubt that what many people perceive to be vaccine injuries have actually been proven to not be caused by vaccines, from allergies and eczema to autism and MS.
“In the absence of a specific etiology for ASDs, and a tendency among parents of children with a disability to feel a strong sense of guilt, it is not surprising that parents attempt to form their own explanations for the disorder in order to cope with the diagnosis.”
Mercer et al on Parental perspectives on the causes of an autism spectrum disorder in their children
Also keep in mind that in addition to the many so-called vaccine induced diseases, there are many historical vaccine injury stories that have been shown to be untrue:
Johnnie Kinnear supposedly began having seizures 7 hours after getting a DPT vaccine, when he was 14-months-old, but medical records actually shown that his seizures started 5 months after he received his vaccines
Dravet syndrome now explains many severe seizures associated with vaccinations
And at least one of Wakefield’s own followers – a mother who claimed that the MMR vaccine caused her son’s autism, was “dismissed as a manipulative liar” by a court in the UK.
Vaccine Injury Stories are Dangerous
Do vaccine injury stories have a purpose? They might help a parent cope with a diagnosis in the short term, but vaccine injury stories are dangerous in so many ways.
We have seen how they create anxiety for many parents, which can scare them away from vaccinating and protecting their kids from life-threatening vaccine-preventable diseases.
What else can they do?
They can certainly build up mistrust towards pediatricians and other health professionals. That is one way that the anti-vaccine movement continues to hurt autistic families. They also can lead parents to think that their “vaccine injured” child is “damaged” in some way.
And they push parents towards dangerous, unproven, unnecessary, and expensive alternative treatments. It shouldn’t be a surprise that many of the sites and forums that push vaccine injury stories also promote a lot of dangerous advice.