Brian Hooker’s vaccine injury claim denied by NVICP

Brian Hooker holds a Ph.D. in chemical engineering and has a background that involves researching and teaching in related areas. He is also the father of a boy – now almost young man, at 16 and a half – with autism. Brian Hooker believes his son’s autism was caused by vaccines, and he has been vocal about it.

He is the one who initiated the most recent claims that the CDC conspired to hide a link between vaccines and autism because of calls he had with a CDC scientist (the so called CDC whistleblower)– claims shown, on examination of the data, to be incorrect. He has also, in recent years, published (problematic) research articles claiming a link between vaccines and autism. One of his articles has been retracted because of undeclared conflicts of interests and methodological flaws.

In 2002 Brian Hooker filed a claim with the National Vaccine Injury Compensation Program (NVICP), the special administrative program created in 1986 to compensate vaccine injuries. On 19 May 2016, the court rejected his claim in a detailed, comprehensive decision. The Special Master explained that “this is not a close case.”

This post explains the decision, explaining the legal framework and the application of it. In short, the claim was rejected because:

  1. The evidence suggested that SRH – the initials by which Hooker’s son was known – had symptoms of Autism Spectrum Disorder (ASD) from early on. In fact, these symptoms appeared long before receiving the vaccines alleged to cause his harm. Moreover, there was no evidence of regression or other severe reaction to the vaccines.
  2. The evidence does not support, and in fact, contradicts, Hooker’s contention that thimerosal-containing vaccines cause autism. This evidence consisted of scientific studies and expert reports. Hooker’s experts’ had questionable credibility and qualifications, and were, at least, far surpassed by the Respondent’s, the Secretary of Health and Human Services, experts.
  3. This decision follows the thorough and detailed Omnibus Autism Proceedings, along with many other decisions that found the same.

Background on Brian Hooker case

 

NVICP spares petitioners from having to show a product defect. To win the case, they need only show causation and damages –  they need to demonstrate the vaccine caused the harm. As detailed in Hooker v. Secretary of HHS, the standard that plaintiffs, like Hooker, need to meet are less demanding than the standard in the regular courts.

Hooker’s initial claim was part of the Omnibus Autism Proceeding, a process in which the question whether vaccines cause autism, a claim made in over 5,000 cases, was examined through decisions in test cases selected by a plaintiffs’ steering committee. As explained by Special Master Hastings, after the claims were rejected in carefully reasoned, detailed decisions (several of which were confirmed on appeal, two confirmed by the circuit court), petitioners had a choice: withdraw their claims, or continue as individuals with claims in the NVICP.

Most of them withdrew their claims. A small number, however, continued to litigate anyway. Dr. Hooker was one of those.

Brian Hooker’s case

 

It’s important to note here that the Brian Hooker petition suffered from repeated procedural irregularities. It’s not clear if the responsibility for the irregularities lies with Hooker’s legal team, or with Hooker himself. On July 20, 2011 Dr. Hooker filed an amended petition that was already problematic on two grounds –

  1. It repeated the claim that thimerosal containing vaccines caused SRH’s ASD, a claim just roundly rejected in lengthy decisions by the program
  2. It claimed, as the culprit vaccines, two vaccines, one of which was MMR – which does not, as the Special Master noted, contain thimerosal.

Since medical causation cases require expert opinion, the special master ordered the petitioners to file one – and petitioners delayed for close to two years, and then filed a report by Dr. Mark Geier from 2007. Dr. Mark Geier, as the opinion scathingly notes, is not a reliable source.

First, Geier was criticized in many NVICP decisions.  Second, by  the time Hooker field Geier’s report, Geier had lost his medical license in all 12 states where he was licensed.  In many states, the delicensure was  because of wrongdoing related to his treatment of children with ASD. It may be that Dr. Hooker was having trouble finding a better expert. But the choice of Dr. Geier was a poor one.

Then, after the respondent filed a motion to dismiss the case based on Dr. Geier’s unsuitability, Hooker’s team filed five more expert reports – including both Geiers, their collaborator Dr. Janet Kern, Dr. Boyd Hayley, Dr.  and Dr. Stephen Smith. Later they filed an additional report by Dr. Mary Megson.

The respondent – the Secretary of Health and Human Services – filed a second motion to dismiss based on the claim that the suit was filed more than three years after the symptoms started, clashing with the program’s strict statute of limitations.

In response, Hooker and his team made a second claim: that the vaccines significantly aggravated an ASD. Because the complaint was already filed in 2002, events in 1999 would be considered timely – even if they were not mentioned in the initial complaint, but added on amendment. Special Master Hastings ordered petitioner to submit additional expert reports to support this second claim, but the petitioner chose not to.

What we see is that repeatedly, Dr. Hooker and his legal team let opportunities to make and support their case go by, and the court gave them repeated opportunities to correct this. They also brought forth what they have to have known is a problematic case.

Why? It’s unclear. Dr. Hooker’s public pronouncements and actions certainly suggest he’s committed to the belief that vaccines cause autism, and the decision points out the sincerity of this belief and his devotion to his son. But he chose an already rejected theory, his experts were problematic and he failed to submit experts reports when instructed, setting the case up for failure.

Special Master Hastings chose to decide on the record, without holding a hearing. He rejected the first claim as barred by the statute of limitations but also went into detail on why both claims – the claim of initial injury from vaccines and the claim of significant aggravation – don’t hold water.

 
 

The decision

 

In deciding causation, the judge addressed both the Althen standard, that applies to vaccine injuries generally, and the Loving standard, that applies to claims of aggravation of a problem. There is significant overlap, so I will address the Althen elements only once.

In Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005) the Circuit Court determined that a petitioner can:

…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.

While it may not be clear to the non-expert reader, the way part 1 works in NVICP is a break for the petitioner. Normally, a petitioner would have to show that the substance in question can cause the injury using scientific literature. In NVICP, expert opinion can substitute: if you have a convincing expert proposing a plausible theory, you can win even without scientific literature showing that the vaccine can cause the problem.

But here, Brian Hooker lost. I am deviating from the order in the decision, which went through the facts first and only summarized the application of the standard at the end, because I think it would help readers to connect the facts with  the standard.

Point 1. A medical theory causally connecting the vaccination and the injury

 

Special Master Hastings explained that this requires petitioners to show that the type of vaccine can cause the type of injury. He found that this element was not fulfilled for two reasons.

First, the qualifications of experts Hooker provided were much less substantial than those of the state. Not only that, but several of the experts for the petitioners were either unqualified or unreliable. In this case, the Court found both Geiers unreliable – Mark Geier because he was found to be non-credible in many previous decisions and lost his license, and David Geier because he had no real relevant qualifications – all he had was a BA with a major in biology.

Special Master Hastings found Dr. Smith to have no specialized education or training in ASD, and pointed to the disciplinary actions against Dr. Smith in cases similar to the case in question, where he was found to provide unsupported diagnosis and subject children with ASD to treatments without basis, to weigh against him.

Dr. Smith was, apparently, the one who connect SRH’s ASD to “mercury toxicity” caused by vaccines, and under his guidance, the boy was chelated. Chelation has no shown benefit for ASD and carries real risks, but that’s what Dr. Smith led Dr. Hooker to use on his son.  In 2005, a young autistic boy died from chelation “therapy”.

Dr. Janet Kern’s credibility suffered from her association with the Geiers, with their complete lack of credibility as scientists or doctors for ASD. She authored 28 articles with them. The Special Master also pointed out that she is not a medical doctor and her expertise is not in the relevant areas, compared to the state’s experts, who are experts in the relevant areas.

Dr. Boyd Haley was found to be less qualified than the state’s expert, Dr. Cetaruk, because his credentials, unlike the latter, were not in medical toxology.

Dr. Megson, while not unqualified, was found less qualified than the state’s expert, Dr. Leventhal. The Special Master also said that “I have myself heard Dr. Megson testify at length, in another case in which she advocated that a vaccination aggravated a child’s ASD, and I found her to be a ‘very unpersuasive’ witness. (See Long v. HHS, 2015 WL 1011740 at *19-20.””

In addition, the Special Master found the reports by the state’s experts much more persuasive and well reasoned. Among other things he pointed out that Hooker’s expert reports did not do a good job explaining why they claim thimerosal containing vaccines cause ASD.

The reports also emphasized alleged harm from cumulative exposure to thimerosal, but Hooker ‘s case rested only on the alleged harm only two vaccines. And the fact that the experts did not support the “significant aggravation” theory worked strongly against that claim.

In contrast, the state’s experts claims were well reasoned and well supported with abundant literature.

Finally, the Special Master reminded us that in the Omnibus proceeding, the special masters examined extensive literature – and it did not support a connection between thimerosal containing vaccines and ASD. It’s worth quoting:

First, while different forms of mercury clearly can be quite harmful to humans at substantial doses (depending on the type of mercury), there is extensive scientific evidence showing clearly that the type of mercury contained in thimerosal-containing vaccines is not harmful to humans at the small amounts contained in thimerosal-containing vaccines. E.g., King v. HHS, 2010 WL 892296 at *29.

Second, extensive scientific evidence shows that when mercury is harmful to humans — that is, when the human brain is exposed to dosages of mercury far higher than the amounts contained in all the thimerosal-containing vaccines that a young child would receive — the harm looks nothing like autism. E.g., King, 2010 WL 892296 at *30.

Third, autopsy studies, comparing brains of autistic children to those of non-autistic children, indicate that autistic brains show a number of abnormal features that necessarily would have occurred during specific parts of the prenatal period, contradicting the theory that vaccinations received after birth could affect autism. E.g., King, 2010 WL 892296 at *32.

Fourth, in the first several years after the theory was first proposed that thimerosal- containing vaccines could cause ASDs, a large number of epidemiological studies33 were carried out, in many countries world-wide, specifically to explore whether there was any association between exposure to thimerosal-containing vaccines and the occurrence of autism. All of the competent, well-designed studies reached the conclusion that no association between thimerosal- containing vaccines and autism had been shown. E.g., King, 2010 WL 892296 at *63-67, 75.

Fifth, a number of prestigious medical groups, including the Institute of Medicine; the World Health Organization; the American Academy of Pediatrics; the European Agency for the Evaluation of Medical Products; the U.S. Centers for Disease Control and Prevention; and the National Advisory Committee on Immunization of the Public Health Agency of Canada, have concluded that the scientific evidence does not support a causal relationship between thimerosal- containing vaccines and autism. E.g., King, 2010 WL 892296 at *75-77.

Thus, while, as noted above, the analysis of the evidence in this case alone thoroughly supports my ruling in this case, it is noteworthy that the extremely extensive and detailed analysis of those three “test-case” opinions, rejecting the same theory advanced by Petitioners here, also supports my conclusions in this case..”

In short, the Special Master found that Brian. Hooker did not show that thimerosal containing vaccines can cause autism at all.

Point 2. Logical sequence of cause and effect

 

The special master explains that the question here is “did the vaccine cause the injury here?” And the answer is a clear no.

First, the Special Master notes that SRH’s pediatricians detailed developmental delays at least since the age of four months, repeatedly noting that the baby failed to meet milestones. Dr. Leventhal’s in his report also noted, based on the medical records, that SRH exhibited symptoms of ASD as soon as 4-8 months.

Second, there was no evidence of SRH experiencing a sudden regression, or an encephalopathy, right after the vaccines in question. The child had low grade fever that lasted a day at some point. But in spite of several medical checks, the child did not suffer prolonged fever or demonstrated regression at that time. This was part of the reasoning with which the Special Master rejected the reports by Dr. Smith, Megson, and Geier, as well.

So no, there was no logical sequence of cause and effect here. This overlaps somewhat with the finding in relation to part 3 of the test:

Point 3. A showing of a proximate temporal relationship between vaccination and injury.

 

The special master explains:

…the evidence indicates that the first symptoms of the initial onset of SRH’s ASD occurred gradually at various times during SRH’s first 15 months of life, not abruptly after any particular vaccinations.

In short, Brian Hooker failed this test clearly. The Special Master analyzed the first claim – of vaccines causing ASD – even though he didn’t have to – since the records showed symptoms of ASD long before the alleged May 1999 vaccines, Hooker’s claim, filed in May 2002, was filed past the statute of limitations and could have been rejected on that basis alone. But the Special Master didn’t take advantage of that: he examined the claim on the merits. The evidence simply didn’t support it there.

Point 4. Significant aggravation

 

Brian Hooker and his lawyers also tried to claim that if SRH had ASD prior to his May 1999 vaccines, the vaccines substantially aggravated that condition. To remind readers, Hooker failed to submit any expert report specifically on that claim. The judge, nonetheless, addressed the factors.

The test for this was set in Loving v. HHS, 86 Fed. Cl. 135, 144 (2009). Petitioner has to show:

(1) the person’s condition prior to administration of the vaccine,

(2) the person’s current condition (or the condition following the vaccination if that is also pertinent),

(3) whether the person’s current condition constitutes a ‘significant aggravation’ of the person’s condition prior to vaccination,

(4) a medical theory causally connecting such a significantly worsened condition to the vaccination,

(5) a logical sequence of cause and effect showing that the vaccination was the reason for the significant aggravation, and

(6) a showing of a proximate temporal relationship between the vaccination and the significant aggravation.

Since 4, 5, and 6 are equivalent to 1,2 and 3 above, respectively, I will only address the first three.

For 1, before the vaccines, the Special Master found that SRH was healthy, but had already symptoms of ASD. As to 1, the Special Master found that “SRH’s condition soon after the vaccinations in question was, contrary to Petitioners’ factual allegations, substantially unchanged from his pre-vaccination condition.” But after August 1999 he had further symptoms of ASD, and hence, under part 3, his current condition is a significant aggravation of his pre vaccine condition – but there’s no evidence the vaccine had anything to do with that.

And again, Hooker’s claims failed to meet part 4, 5, and 6.

So in short, Hooker failed dramatically and thoroughly in proving the vaccines his son got on May 1999 either caused his son’s ASD or significantly aggravated it. There was no evidence in the record of a dramatic regression. In fact, the Special Master noted, drawing on Dr. Leventhal’s report,

SRH’s developmental course in fact followed ‘a more-or-less typical course of the gradual appearance of symptoms of broad based developmental delays.

The implications

 

This is a careful, thoughtful, and thorough decision. The Special Master expressed his sympathy to Dr. Hooker and his family, but ruled on the facts as the record reflected them. He said (emphasis added):

The record of this case demonstrates plainly that SRH and his family have been through a tragic ordeal. … the great dedication of SRH’s family to his welfare is readily apparent to me.

Nor do I doubt that SRH’s parents are sincere in their belief that SRH’s vaccinations played a role in causing or aggravating SRH’s autism. SRH’s parents have heard the opinions of Dr. Smith, Dr. Megson, and other physicians who profess to believe in a causal connection between thimerosal-containing vaccines and autism.

After studying the extensive evidence in this case, I am convinced that the opinions provided by Petitioners’ experts in this case, advising the Hooker family that there is a causal connection between SRH’s vaccinations and either the initial causation or aggravation of SRH’s ASD, were quite wrong. Nevertheless, I can understand why SRH’s parents found such opinions to be believable under the circumstances. I conclude that the Petitioners filed this petition in good faith.

Thus, I feel deep sympathy for the Hooker family. Further, I find it unfortunate that my ruling in this case means the Program will not be able to provide funds to assist this family, in caring for their child who suffers from a serious disorder. It is my view that our society does not provide enough assistance to families of all autistic children, regardless of the cause of their disorders. … Such families must cope every day with tremendous challenges in caring for their autistic children, and all are deserving of sympathy and admiration.

However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of individuals whose injuries or deaths can be linked causally, either by Table Injury or presumption or by preponderance of “causation-in-fact” evidence, to a listed vaccine. In this case, the evidence advanced by Petitioners has fallen far short of demonstrating such a link.

We certainly need better funding for families with disabled children, but that’s not NVICP’s purpose. Special Master Hastings made it clear that the evidence goes against the claim that vaccines caused SRH’s ASD.

Part of the problem was the low quality of the experts supporting Hooker’s view. Was Hooker unable to find other experts because most scientists realize the claim that thimerosal in vaccines causes ASD is long disproven, or did he turn to those he knew and trusted, regardless of how the court would see them? I do not know.

This strong decision shows the inaccuracies of the story of Dr. Hooker and his family as included in the documentary Vaxxed. This decision makes it clear his son’s ASD predated the vaccines.

Will Hooker, knowing this, make a public statement that his son’s story in Vaxxed is incorrect? If he still believes vaccines caused SRH’s ASD, it’s unlikely. But it is fair and appropriate for others to point that out, to remind everyone that at least one of the stories in Vaxxed has now been legally found – in a carefully reasoned decision – not to be the result of vaccines. If this story is left in the movie, it should reflect on the movie’s credibility – if it includes one story clearly demonstrated to be incorrect, why should we believe the rest of it?

This further demonstrate why anecdotes – the backbone of the movie – are not a good way to counter the kind of extensive scientific data that shows that vaccines don’t cause autism –  they can easily be wrong, even if the parents sincerely believe them.

This decision also highlights the lack of support for the myth that vaccines cause autism. Over half of the experts supporting Dr. Hooker’s claims have faced sanctions for problematic behaviors related to the claim that vaccines caused autism.

Drs. Smith and Geier, as well as Mr. David Geier, were disciplined for their treatment of autistic children. Dr. Boyd Haley was sanctioned by the FDA for misusing a chelator (which could be used to cure the vaccine-caused mercury-poisoning he writes about). The experts’ reports were found badly based and badly reasoned as well.

What are the options available to Hooker now? He could appeal the decision to the Court of Federal Claims, and if rejected there to the Circuit Court of Appeals, and if rejected there could try and appeal to the Supreme Court (though the case being taken there is extremely unlikely). But this is a carefully reasoned, thoughtful decision. Hooker is unlikely to win, not even on the Special Master’s decision not to conduct a hearing, which was also clearly explained.

Update: I have been informed that Hooker has not requested a review of the decision by the Court of Federal Claims, the first step of the appeals process, and we are now past the time to do so, unless he requests an extension and justifies it.

We could hope that, realizing how unassailable the Special Master’s decision is, Dr. Brian Hooker will withdraw from attacking vaccines and arguing against protecting children from disease, and will relinquish his claim that vaccines cause his son’s autism. That, however, is unlikely. Dr. Hooker seems entrenched in his views. He is likely to hold to them and keep attacking vaccines, even though his claim in relation to his son has been resoundingly disproven.

The rest of us, however, should see this decision as adding to the mountain of proof that there is, in fact, nothing to this claim.

Full decision can be found here – Hooker NVICP decision

Dorit Rubinstein Reiss
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy and the law. 

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.