Gardasil(HPV) Vaccine Found to Cause Miller-Fisher(MF) Variant of GBS


D.S. v . HHS, No. 10-077V (Fed. Cl. Spec. Mstr. May 19, 2015)(Dorsey)

Entitlement decision holding that petitioner had established that (1) she had the Miller-Fisher variant of GBS and (2) that it was caused by the Gardasil vaccine.

Testifying for the petitioner was David Axelrod, M.D., an immunologist, and Stephen Schecter, M.D. a treating neurologist.

Testifying for the respondent, was neuroimmunologist Thomas Leist, M.D.

This petitioner had a complex medical history and an unusual presentation of GBS consisting primarily of facial nerve palsies.  Complicating the diagnostic issue was a past history of rheumatological visits, hearing loss and possible Lyme disease.  Thus, her diagnosis was hotly contested, both what it was and whether it predated the vaccine.  In this case, the special master held that a Broekelschen inquiry was necessary to determine whether the petitioner in fact had GBS.

In holding that petitioner did have GBS, the special master noted that although the petitioner did not present with the classic triad of symptoms of MF, at least five of her treating physicians either considered that diagnosis or actually made that diagnosis.  One of those treaters testified at the hearing and opined that the petitioner’s improvement on IVIG further supported the diagnosis.  Respondent noted that the CSF and anti-ganglioside antibody studies were both negative and the petitioner’s clinical presentation was inconsistent with MF.

With respect to the petitioner’s pre-vaccine symptoms, the special master observed that no cohesive diagnosis was ever reached to explain them.  In addition, the special master reviewed several pre-vaccine records that indicated that the petitioner suffered from only minor complaints at the time of the vaccine.  Because the special master found the petitioner had experienced a de novo onset of MF post-vaccine, it was unnecessary to address the petitioner’s alternative significant aggravation claim.

Turning to the analysis of Althen prong one, the special master found that the petitioner provided preponderant evidence that Gardasil can cause GBS, (specifically MF), via molecular mimicry.  Dr. Axelrod testified fairly generally about his mimicry theory indicating that Gardasil contained the L1 and L2 proteins which are similar to structures present in the myelin of the nervous system [Ed. Note – only L1 proteins are in the vaccine, not L2 proteins, and the special master did note this].  Therefore, antibodies developed in response to the vaccine “damage the normal structures in the human host, including possible damage to the nervous system.”  Dr. Axelrod relied upon Wucherpfenning (1995) for the proposition that there is “some structural homology between the vaccine peptides and a portion of the myelin basic protein . . .cell receptors and antibody receptors recognize the structures on myelin as they recognize the structures on the Gardasil vaccine.”  [Ed. Note -this article, in Table 1, does contain sequence similarities between MBP and wild HPV, however, it cannot be determined from the article whether these are the 4 strains included in the vaccine.  That is not to say a petitioner’s burden of proof would require that degree of specificity, although this is an unsettled area].

In response to Dr. Axelrod’s theory, Dr. Leist did not oppose the plausibility of molecular mimicry in general. Dr. Leist testified that it is always possible to find short sequence homologies between peptides [in the vaccine and the target tissue], but this doesn’t establish that a cross-reactive immune response will take place.  For example, Kanduc (1995) demonstrates only potential cross-reactivity between HPV16 and various human proteins, Dr. Leist argued, consistent with the IOM’s position that sequence homologies do not provide proof of biologically important reactions.

In deciding prong two, the special master gave careful consideration to the testimony of the petitioner’s treating neurologist, noting that the Capizzano court found they are likely to be in the best position to determine whether a logical sequence of cause and effect exists.

As far as timing, Althen prong three, Dr. Axelrod testified that 39 days was within a medically-accepted time frame, which he testified was one to six weeks.  He also seems to have testified that a primary immune response would take at least two to three weeks.  On this point, Dr. Leist conceded that an outer limit of six weeks could be extrapolated from the swine flu vaccine studies [Ed. Note – e.g., Schonberger 1979].

The special master also held that Respondent had failed to establish alternate causation, even though some treating physicians had considered viral neuritis or an undiagnosed connective tissue disease.  That evidence did not outweigh the five treating physicians who considered or diagnosed MF.

In closing, the special master held that the petitioner was entitled to compensation because she had provided sufficient circumstantial evidence that preponderated in her favor.

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