US Court of Appeals denies vaccine court case

14 May

The first of the vaccine court autism cases has been denied by the United States Court of Appeals, Federal Circuit. The Vaccine court (or, more accurately, the U.S. Court of Federal Claims) grouped the autism claims into an “Omnibus”, something like a class action case, where evidence to prove vaccines cause autism was presented in a few “test cases”, rather than hearing all the cases individually. The Omnibus Autism Proceeding heard six test cases, three on the theory that the MMR vaccine causes autism and three on the theory that thimerosal (a mercury containing perservative) causes autism.

The appeals decision is for the test case of Yates Hazelhurst, one of the MMR test cases. The case was summarized by the Special Master who decided the case:

[P]etitioners assert that the measles component of the MMR vaccine causes an immune dysfunction that impairs the vaccinee’s ability to clear the measles virus. Unable to properly clear the measles virus from the body, the vaccinee experiences measles virus persistence which leads to chronic inflammation in the gastrointestinal system and, in turn, chronic inflammation in the brain. Petitioners argue that the inflammation in the brain causes neurological damage that manifests as autism.

The Special Master (essentially the Judge in the vaccine court) denied the claim. The family appealed to the Court of Federal Claims, who upheld the decision. The recent decision is from the United States Court of Appeals, Federal Circuit, making this the second appeal affirming the original decision.

The family appealed on the basis, as the appeals judge put it:

On appeal to this court, the Hazlehursts argue that the special master improperly relied on certain evidence that should have been excluded and disregarded other evidence that should have been considered.

The MMR theory for autism causation relies on the notion that the measles virus from the vaccine persists in the guts of children. This, in turn relies on research by Dr. Andrew Wakefield’s team and in particular, the Unigenetics laboratory. The government brought in a witness, Dr. Stephen Bustin, to refute the validity of the results from the Unigenetics lab. Dr. Bustin’s testimony and level of expertise were very clear in showing that the Unigenetics results were faulty.

The special master found that Dr. Wakefield’s work had been largely discredited within the scientific community and that 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. In particular, the special master found that Dr. Wakefield’s early 1990s research on persistent measles infections was reviewed by the Medical Research Council of the United Kingdom and found to lack important controls and sufficiently specific reagents for detecting measles virus. She also found that Dr. Wakefield’s subsequent research was dismissed by the scientific community as methodologically unsound. In that regard, she noted that 10 of 12 co-authors on Dr. Wakefield’s controversial 1998 article in the medical journal The Lancet subsequently retracted their support for the article’s conclusion that there is a potential causal link between the MMR vaccine and autism.

The Special Masters allowed the petititioners (including the Hazelhursts) time to rebut Dr. Bustin’s testimony, through cross examination and through documentation from the UK MMR litigation. The petitioners did not avail themselves of this opportunity.

Over objection, the government sought to introduce Dr. Bustin’s reports and testimony regarding the Unigenetics laboratory, which, by that time, had gone out of business.[ 2 ] The special master in the Cedillo case provisionally admitted the evidence. The three special masters in the omnibus proceeding then deferred decision on whether to rely on that evidence and stated that they would “favorably consider joining in a request” by the petitioners “for the release of relevant reports” from the UK litigation. The record remained open for more than a year following the Cedillo hearing to afford the petitioners sufficient time to present rebuttal evidence, to conduct additional cross-examination of Dr. Bustin, and to obtain documents from the British court. However, none of the petitioners recalled Dr. Bustin for further questioning or applied for access to any of the materials from the UK litigation.

The Hazelhurst’s argued that evidence should have been allowed that was not. In particular, they argued that some unpublished results demonstrate the persistent measles theory.

The special master further concluded that the unpublished and preliminary findings of the Walker group should not be accorded significant weight. She observed that Dr. Hepner had declined to “draw any conclusions about the biological significance” of the investigators’ findings and had testified that negative controls were not included with each experimental run. The special master also noted that the petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus, as opposed to the vaccine-strain measles virus, which is far less virulent and replicates poorly in the human body.

In the end, the appeals judge ruled that there was no reason to overturn the original decision:

Because we find no error in the special master’s consideration of the evidence, we also find no error in her decision to discount Dr. Corbier’s opinion that the MMR vaccine caused Yates’s autism. By Dr. Corbier’s own admission, his opinion depended heavily on the reliability of the scientific studies purporting to show measles virus persistence in autistic children.

Compensation under the Vaccine Act is limited to those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. The special master concluded that the Hazlehursts’ evidence failed to demonstrate the necessary causal link, and the petitioners have not identified any reversible error in the special master’s decision reaching that conclusion.

The petitioners now have the choice of appealing to the U.S. Supreme Court. As noted above, the Supreme Court hears cases which help define laws and this does not appear to be such a case. It would seem unlikely, then, that the Court would agree to hear this case. If so, this is the end of the appeals for the Hazelhurst’s in their case against the U.S. government. The next step would, then, be to take their case to civil court against the vaccine manufacturers. Such cases have not been successful so far. Civil cases require a higher level of evidence and expertise than the vaccine court. Having failed in the Federal Court, where the rules are more favorable to the petitioners, it would seem a difficult battle to win the case in civil court.

3 Responses to “US Court of Appeals denies vaccine court case”

  1. brian May 15, 2010 at 03:03 #

    The special master further concluded that the unpublished and preliminary findings of the Walker group should not be accorded significant weight.

    It’s interesting to see Walker’s 2006 abstract raised again, despite the fact that the preliminary work reported there remains unpublished four years later, just as the 2004 IMFAR abstract from Walker, Wakefield, and others that reported the presence of measles virus in the cerebral spinal fluid of children with ASD remains unpublished. Those preliminary reports have been cited as support for the discredited MMR-causes-autism meme, especially with respect to the “Uhlmann” paper from Wakefield and others.

    Perhaps the work of Stephen Bustin, an internationally-recognized expert in the PCR reaction that is the basis for Walker and Uhlmann’s research, can suggest why neither of those PCR-based investigations has been reported. In the first paper listed below, Bustin uses the Uhlmann paper as an example of how NOT to use PCR in clinical investigations, and in the second Bustin completely dismantles the Uhlmann paper, step by step. As Bustin said of the MMR-autism connection, “There’s nothing in it.”

    One of the most astonishing examples of the enormous implications for the health and lives of [misapplications of PCR] is provided by the controversy surrounding the triple MMR virus vaccine. RT-qPCR data appeared to demonstrate the presence of measles virus RNA in children with developmental disorders, which was interpreted as providing hard scientific evidence for a link between MMR, gut pathology, and autism. However, detailed analysis of the raw data underlying that report . . . revealed a catalogue of mistakes, inaccuracies and inappropriate analysis methods as well as contamination and poor assay performance. The assay had been detecting DNA, and since the measles virus is an RNA-only virus, the RT-qPCR data had been erroneously misinterpreted. Interestingly, a recent paper that included two of the authors from the initial [Uhlmann] report was unable to reproduce the original findings and concluded that there was no link between autism and enteropathy.

    Click to access murphy-bustin-review-qpcr-optimization-2009.pdf

    In a detailed critique of the Uhlmann work that involved analysis of the techniques, equipment, and raw data, Dr. Bustin concluded that “there is no credible evidence of either [measles virus] genomic RNA or mRNA in the GI tracts (or blood samples) of any patient investigated [by Uhlmann et al.] Consequently, this finding excludes any link between [measles virus] and, by extension, the MMR vaccine and autism.”

    Click to access erp_mmr.pdf

    Is there any wonder that work reported in Walker’s abstracts, which supposedly supported the conclusions reported by Uhlmann, remains unpublished?

  2. Julian Frost May 15, 2010 at 19:54 #

    It gets even better. I just took a much closer read-through of the document. The parents of Michelle Cedillo and Colten Snyder were the test cases for MMR Vaccine in combination with thimerosal causing autism. Yates Hazelhurst’s parents opted to take the MMR causes autism route. The last hope of the Omnibus Autism Proceeding families is if the parents of Colin Dwyer, Jordan King, or William Mead mount a successful appeal. Judging by the courts’ rulings so far, any appeal will be unsuccessful.


  1. Tweets that mention Autism Blog - US Court of Appeals denies vaccine court case « Left Brain/Right Brain -- - May 14, 2010

    […] This post was mentioned on Twitter by Brandon Blietz. Brandon Blietz said: US Court of Appeals denies vaccine court case: The first of the vaccine court autism cases ha… […]

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