Whitney v. HHS, Case No. 10-809V (Fed. Cl. Aug. 12, 2015) (Lettow, J)

The Special Master had denied entitlement in this case which alleged TM caused by DTaP vaccine, finding a failure of prong 2 under Althen, in light of the HHV-6 infection (this decision was included in last month’s case law summary).

The reviewing judge summarized the special master’s findings on prong 2: 1) Petitioners presented a plausible case for vaccine causation, however, this belief conflicted with the opinions of the treating physicians, 2) Petitioners failed to identify a single medical record where a treater expressed an opinion supporting causation, and 3) Petitioner’s expert opinions were “thin and not persuasive” and failed to amount to that something “more” needed to establish prong 2.

On appeal, Petitioner argued, among other things, that the Special Master improperly drew inferences from the record. The reviewing court agreed, holding that the special master made findings and conclusions that were contrary to the evidence of record and thus were arbitrary, capricious, and an abuse of discretion, in his analysis of Althen prong 2.  Thus, the court set aside the factual findings on prong 2 and remanded for further proceedings.

For example, an inference about what a treating physician might have told Petitioners about causation was “wholly unreasonable and lack[ed] credible support in the medical records.”

In response to the special master’s holding that petitioner failed to “identif[y] even one medical record in which a treating doctor expressed the opinion that a vaccination caused the transverse myelitis,” the reviewing court held that this determination was “captious and untenable,” and that the infectious disease specialist’s consideration that the vaccinations may have been a cause of his transverse myelitis [along with HHV-6 which was also considered] and his decision to report the adverse event to VAERS counted as “one medical record” expressing an opinion in support of vaccine causation.

The reviewing court agreed with Petitioner that it was appropriate to evaluate a treating physician’s statements regarding causation in light of their pro-vaccination point of view or “evident emphasis on vaccinations notwithstanding contraindications.”

Petitioner contended that “[i]t is clear that the special master desired a certain result, and misconstrued the evidence in order to reach that result;” the reviewing court apparently agreed, holding “[t]here are indicia that the special master did what the Whitney’s claim.”

The reviewing court did affirm one of the special master’s disputed factual conclusions from the evidence, regarding the significance of the treatment plan to the causality analysis.

In reviewing the evidence presented on Prong 1, the reviewing judge highlighted Agmon- Levin [Shoenfeld et al.]  (2008), Transverse myelitis and vaccines: a multi-analysis, which had been relied upon by Petitioner’s experts in support of molecular mimicry, epitope spreading and polyclonal and bystander activation.   With regard to these mechanisms, the reviewing judge noted that only Dr. Wiznitzer, “who appears regularly for the [g]overnment in Vaccine Act cases,” opined that the mechanisms operated exclusively in the case of infections but not vaccines.  The Court also observed that the government’s immunologist had testified that he would only tell a family that DTaP caused TM if “a neurosurgeon went in and biopsied the spinal cord and a pathologist found pertussis antigen, or tetanus toxoid, or diphtheria toxoid, adherent to components of his bone marrow.”  The court stated that requiring proof of causation in that way would amount to scientific certainty, an impermissibly high burden of proof.

In remanding the case for new findings of fact on prong 2, the reviewing court anticipated “the distinct possibility that the Whitneys have, or will establish on remand, a prima facie case of causation under the Vaccine Act,” urging the Special Master to make explicit findings in this regard.  Likewise, findings should be made with respect to whether the government can demonstrate by a preponderance of the evidence that the TM was caused by a factor unrelated, HHV-6.

Finally, the reviewing court suggested that this “may well be a case in which it is appropriate to obtain testimony from . . .  physicians who treated S.W. upon hospitalization, to gain a better understanding of the most relevant medical records,” meaning their statements about causality.

 

News, Uncategorized, Vaccine Case Reviews Reversal of Denial of Entitlement in Case Alleging TM Caused by DTaP; Factual Findings Underlying Analysis of Althen Prong 2 were an Abuse of Discretion and Vacated; Remanded.