Entitlement Denial–DTaP Alleged to Cause Transverse Myelitis
Whitney v. HHS, Case No. 10-809V (Fed. Cl. Spec. Mstr. Jul. 20, 2015) (Moran)
Testifying for Petitioner were Yuval Shafrir (pediatric neurologist), and James Oleske (immunology and pediatric infectious disease)
Testifying for Respondent were Raoul Wientzen (pediatric infectious disease) and Max Wiznitzer (pediatric neurology).
Petitioners presented a theory that the DTaP vaccine caused Transverse Myelitis through an autoimmune process such as molecular mimicry, epitope spreading, or bystander activation. Respondent’s experts agreed that these mechanisms were at work in post-infectious cases of TM. When asked whether these processes could also cause post-vaccinal TM, Respondent’s pediatric ID expert Dr. Wientzen agreed that they “would apply equally to vaccine as infection.” Dr. Wiznitzer did not agree.
With regard to Althen prong 1 – the court held that it was “relatively easy” to find that Petitioners had presented a “plausible medical theory to explain how a vaccine can cause transverse myelitis,” but whether this evidence rose to the level of preponderant evidence was a more difficult question, the Court noted. The Court added that a plausible medical theory is not the same as a persuasive theory, citing Moberly. Ultimately, the court held:
For purposes of this decision, it is assumed that the petitioners meet their burden of proof for Althen prong 1. This assumption can be made because the evidence regarding prong 2 is decisive.
In the Court’s analysis of prong 2, the statements of treating physicians were evaluated. The Court determined that several of the notations relied upon merely reflected the parental history given, rather than a medical opinion regarding causality. Although one doctor had initially identified a post-vaccination reaction as one of many potential causes, the same doctor later wrote that the child’s HHV6 infection or his immunizations “could have been the trigger.” Thus, the Court did not consider these statements as materially supporting the case. Respondent pointed out that the child’s pediatrician specifically considered and rejected the idea that the vaccine was causal and recommended that the child continue to receive all of his immunizations. The Court found this evidence to be “remarkably strong and direct.” Finally, a treating neurologist diagnosed HHV6 myelitis, and there was circumstantial evidence that an infectious disease specialist also concluded that HHV6 was causal.
In addition, Petitioners disputed that HHV6 can cause TM, noting that Dr. Wientzen had conceded there was no homology between HHV6 and spinal cord components. To this point, the Court stated:
The potential trouble with the Whitneys’ attack is that the arguments they raise against the lack of evidentiary support for the theory that HHV-6 can cause transverse myelitis are arguments that could undermine the theory that the vaccines can cause transverse myelitis. In seeking to tear down the Secretary’s home, the Whitneys risk destroying their own edifice.
The Court added that Petitioners’ experts had not presented evidence of homology between DTaP and spinal cord components and that Dr. Shafrir had testified that the lack of common homology didn’t mean anything.
In the final analysis of prong 2, the Court concluded that Petitioners’ evidence on prong 2 came down to three propositions, which, even if true, were legally inadequate: “(1) the vaccine can cause the disease, (2) the timing is appropriate, and (3) the exclusion of other potential factors.” Because the treating physician evidence supported Respondent’s case, Petitioners could not supply that something “more” needed to prevail on prong 2. Thus, Petitioners were not entitled to compensation.
Althen prong 3 – timing – was not in dispute; all experts agreed that 7-10 days was appropriate temporally.
