Entitlement – Multiple Sclerosis Caused by Hep B Vaccination


Valle v. HHS, (Fed. Cl. Spec. Mstr. Apr. 18, 2016) (Gowen, SM)

This case involved a major dispute as to the timing of onset of Petitioner’s MS.  Petitioner contended that her MS began between 4 and 42 days after the third dose of Hepatitis B vaccine; Respondent argued that her MS preceded the vaccine.  The special master held that the onset issue was a close call, and resolved that issue in favor of the petitioner.

With regard to Althen prong one, the court observed that the issue of Hepatitis B causing demyelinating disorders such as MS had been extensively litigated in the program in a prior omnibus proceeding.  In those cases, the court found that the Hepatitis B vaccine could cause MS, along with GBS, TM, and CIDP. The court commented that the medical understanding of the cause of MS is much the same today.

Hep B Vaccine Can Act As Environmental Trigger to MS

The court rejected Respondent’s expert’s argument on prong one, which was largely based on epidemiology.  The Court held that Petitioner’s expert had presented a scientifically reasonable theory of how the Hepatitis B vaccine can act as the environmental trigger of MS through the mechanism of molecular mimicry, particularly with myelin oligodendrocyte protein (MOG) [as opposed to MBP].  It cannot be determined from the decision the degree of homology that was demonstrated between the Hepatitis B vaccine and MOG or whether evidence of cross-reactivity was available.

Prong two was relatively easy to establish, once the timing issues were resolved in petitioner’s favor, since she gradually developed a clinical picture of MS after the third Hepatitis B vaccination and there were no other triggers.  Petitioner’s proposed time frame for onset of symptoms, between 4 and 42 days, was found to be an appropriate temporal interval under prong three.

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