Case Delayed for Evaluation of Prong 1


Godfrey v. HHS, Case No. 10-565V (Fed. Cl. Aug. 19, 2015) (Firestone, J)

Case Remanded for Reconsideration of Prong 1 in Light of Circuit’s Decision in Koehn Which Involved Same Experts, Same Vaccine (HPV), Same Theory and Similar Injury (SJIA vs. JAS).

Appeal from a denial of entitlement in a case alleging juvenile ankylosing spondylitis (“JAS”) caused by Gardasil vaccine.  The Chief Special Master had ruled that Petitioner’s medical theory, that the HPV vaccine “triggered” the JAS in a manner similar to other environmental triggers, was not sufficiently plausible under Althen.  The court also held that Althen prong 3 was not met.

On appeal, Petitioner contended that she presented a viable, legally-probable medical causation theory and that the Federal Circuit’s intervening decision in Koehn v. HHS militated a different result.

Petitioner was positive for the HLA-B27 haplotype [the first human leukocyte antigen to be associated with human inflammatory disease], denoting a genetic susceptibility for JAS and other conditions.  Petitioner’s expert microbiologist and immunologist, (a PhD but not an MD), testified that the HPV vaccine triggered the release of proinflammatory cytokines, which in turn triggered the onset of JAS.  He acknowledged that stress, trauma and infection were all known environmental triggers of JAS, but concluded that HPV was likely the trigger in this case.

Respondent’s experts (pediatric rheumatologist and immunologist) testified that JAS is caused by genetics and stressors, and that proinflammatory cytokines are not involved in the pathogenesis of the disease, although they may impact the symptomatology of the disease.  They further testified that one dose of Gardasil would be insufficient to trigger JAS symptoms.

The Chief Special Master held that Petitioner’s JAS was attributable to her “genetic background, coupled with a family history and the presence of a known ‘trigger’ for development of JAS” – cheerleading.  With respect to the experts, the court held that Petitioner’s PhD immunologist was “out of his depth in presenting a theory of the cause of a medical condition, with little, if any, support in the medical and scientific literature” whereas Respondent’s pediatric rheumatologist, who diagnoses and treats JAS, was more “familiar with the etiologic factors that are accepted as causal in the scientific and medical communities.”  With regard to Althen prong 2, the court noted that there was nothing in the medical records linking the vaccine and the onset of symptoms.  Neither was prong 3 established because, according to Respondent’s expert, it was too difficult to determine when the disease began.

The reviewing court noted that, in the Koehn case, the petitioner had relied on the same PhD immunologist and medical theory to explain how Gardasil caused her systematic juvenile idiopathic arthritis (“SJIA”), and Respondent had relied on the same pediatric rheumatologist to rebut the theory.  The special master in Koehn had denied entitlement, holding that Petitioner’s medical theory failed because it was not peer-reviewed and Respondent’s expert had never heard of it.  The Federal Circuit ultimately affirmed the denial of entitlement on prong 3 grounds, but noted that the special master had committed several errors in the analysis of prongs 1 and 2.  As to prong 1, the special master was criticized for requiring acceptance in the medical community and for discounting Petitioner’s PhD immunologist because he did not treat patients: “[w]e see no reasonable basis for why this distinction has any meaningful effect on the cause and effect inquiry.”  The Court went as far as to indicate that the special master likely would have found in Petitioner’s favor on prong 1 if the evidence had properly been evaluated.  Specifically, in discounting the medical literature relied upon by Petitioner based on Respondent’s expert’s criticisms of the applicability of the paper, the special master improperly required Petitioner to “present more than what is scientifically possible or legally necessary.”  Thus the Circuit held, in Koehn, that Petitioner had presented a “viable, ‘legally probable’ medical theory.”

Noting the Koehn court’s criticisms of the special master were dicta, the reviewing court nevertheless remanded to the special master to determine whether Petitioner’s expert identified a legally probable theory of causation with regard to the HPV vaccine to satisfy the first prong of Althen, given the similarities between the two cases.

It should be noted that Respondent’s argument on appeal was that, although petitioner presented a theory that the HPV vaccine might be a trigger for JAS symptoms, Petitioner failed to present evidence to support a finding that the HPV vaccine actually “causes” JAS as required by Althen. The government relied on the testimony of its expert to draw a distinction, which the chief special master accepted, between the vaccine triggering the onset of symptoms in a patient with existing-but-dormant JAS and the vaccine actually causing JAS itself.

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