McCulloch v. HHS, No. 09-023V (Fed. Cl. Spec. Mstr. May 22, 2015) (Gowen)
Gardasil (HPV) vaccine found to have caused child’s autoimmune encephalitis (ALE) and resultant seizures through molecular mimicry between the Aquaporin 4 (AQP-4) receptors in the brain and HPV strains 16 and 18 in the vaccine.
A 12 year old girl developed a fever, sore throat and refractory seizures five weeks after her second HPV vaccine. Numerous anti-epileptics and IVIG failed to control the seizures and she deteriorated clinically while hospitalized for months with a diagnosis of encephalitis, likely viral. Even after brain surgery and a vagal nerve stimulator implant, the seizures persisted and the preteen was left with profound intellectually impairment and personality change.
Neurologist Svetlana Blitsheyn, MD, and neuroimmunologist Lawrence Steinman, MD, testified for Petitioner, opining that Gardasil caused the child’s autoimmune limbic encephalitis.
Neurologist Arun Venkatesan testified for Respondent proposing an alternate diagnosis of Febrile Infection-Related Epilepsy Syndrome (FIRES), and questioning the proposed mechanism of vaccine causation.
As an initial matter, the court rejected Respondent’s position that a preliminary ruling on diagnosis was required under Brokelschen reasoning that all experts were considering the same injury, albeit giving it different names. Nevertheless, the court accepted Petitioner’s proffered diagnosis of ALE.
Dr. Steinman testified that there is molecular mimicry between the HPV virus like particles 16 and 18, which are found in the Gardasil vaccine, and the AQP-4 water channels in the brain. Specifically, he demonstrated three different sequence homologies of 5-6 amino acids each, more than is needed to induce cross-reactivity. Further, he explained that emerging research shows that the AQP-4 water channels are likely to play an important role in epileptogenesis [editorial note – AQP-4 is also the target antigen in neuromyelitis optica (NMO)].
Dr. Venkatesan questioned whether the homologies shown were sufficient to induce mimicry. He also would have liked to see studies that showed actual, not theoretical, cross-reactivity. Finally, he questioned the degree of proof adduced that disruption in the AQP-4 channels could cause seizures.
The special master noted that Respondent’s expert’s expectation of the level of proof needed to establish causality was understandable from a scientific standpoint, but was inconsistent with congressional intent behind the Vaccine Act. Citing Knudsen, the court held that Respondent’s expert’s criticisms of Petitioner’s theory were inapposite, as scientific certainty was not the appropriate standard of proof.
With respect to Althen prong one, the court found Petitioner’s theory of causation was “physiologically reasonable and persuasive” and supported by peer-reviewed literature. “In fact, petitioner has presented more specific evidence than that which would be necessary to carry her burden.”
The court credited Dr. Steinman’s use of differential diagnosis, in its analysis of Althen prong two, noting that the methodology satisfies Daubert. Respondent argued that no treating physicians implicated Gardasil, however the court pointed out the vaccine may not even have been considered in the initial workup and that the treating physicians had ruled out all other potential causes. Experts for both sides agreed that there could have been an unknown virus or as yet unidentified autoimmune, genetic or molecular cause, however this could not constitute a factor unrelated such as to defeat Petitioner’s recovery. Althen prong three, timing, was not in dispute.
In closing, the Court noted that the alternative diagnosis proposed by Respondent, (FIRES), could not be a legal alternative cause because it was idiopathic – Petitioner had not advanced this argument.
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