McGuire v. HHS, (Fed. Cl. Spec. Mstr. Sep. 18, 2015) (Moran, SM)
The bottom line holding is that the Petitioner “failed to present a reliable basis for concluding, on a more-likely-than-not basis, that the HPV vaccination can cause headaches that last for months and years.”
As a preliminary matter, the Court accepted the parties’ stipulation that precise type of headache disorder did not matter because the mechanism asserted could apply equally to either diagnosis, avoiding a Broekelschen inquiry.
Petitioner presented testimony from a pediatric neurologist and a pharmacologist (non-MD) specializing in headache pain management. Respondent presented a pediatric neurologist and an immunologist.
The medical theory presented was: 1) the HPV vaccine promotes the production of various cytokines, including TNF; 2) from the body’s periphery, TNF crosses the blood-brain barrier to reach the central nervous system; 3) in the central nervous system, TNF causes inflammation producing headaches.
The Court found multiple problems with the medical theory. Relying on the IOM, the court held there was “no evidence that directly or indirectly supports the oversecretion of cytokines as an operative mechanism” in disease, and Petitioner offered no evidence to rebut that conclusion. Petitioner’s expert admitted that he did not know the amount of TNF that was required to cause a disease.
Additionally, Petitioner’s experts presented no support for the assertion that TNF can cross the blood-brain barrier, which was essential to the theory. Finally, the primary article upon which petitioner relied was significantly criticized and Petitioner’s experts were unable to meet the criticism.
Ironically, the Court held that the third step of Petitioner’s causation theory was established by Respondent’s expert’s testimony.
A prong 2 discussion was unnecessary given the failure of prong 1, however, the court held that a treating physician’s “report that he could consider an immune mediated process a “possibility” does not satisfy the preponderant evidence standard”. The Court also opined that no evidence was adduced that an alternative medicine practitioner had any expertise to opine on causation.
The Court considered Petitioner’s challenge-rechallenge argument and the Secretary’s challenge-dechallenge argument but was not persuaded by either.
On prong 3, timing, the Court pointed out that Petitioner’s expert never established what the appropriate temporal interval would be for a cytokine-driven reaction.
As an aside, the court held that Respondent’s criticism of Petitioner’s use of a pediatric neurologist in a case involving onset at age 20 was not meaningful in absence of a showing that the condition differed in the adult population versus the pediatric population. The Court did agree that Petitioner’s expert neurologist’s “lack of specialization in immunology makes his opinion on immunologic topics less valuable than the opinion of [Respondent’s expert], who is an immunologist.” For example, his knowledge of the function and working of cytokines was limited; he was unable to discuss how cytokines like TNFα are produced, stating instead that he would have to defer to an immunologist.
Likewise, the special master criticized Respondent’s choice of neurologists, noting that one of his current responsibilities is treating patients at a hospital with 11 beds. Although the special master accepted him as an expert in adult neurology without objection from Petitioner, he noted that if the “case required expertise specifically on headaches, then it was not apparent that [the expert] would be of much assistance.” The Court also pointed out “a series of missteps in his reports,” such as proposing various alternative causes for the headaches which he was forced to modify or retreat from on cross-examination. The court went as far as encouraging him to use more care in how he writes his reports in the future.
Similarly, the Court noted that the testimony of Petitioner’s pharmacologist was “not very helpful,” in response to Respondent’s immunologist. Also mentioned was the fact that she was unable to cogently discuss an article of which she was a co-author, deferring to the primary author. The Court cautioned program attorneys against retaining this expert in the future.
At hearing, when an expert attempts to present an opinion not disclosed before hearing, the opposing party may seek to strike that testimony, the Court held. The failure to move to strike the testimony constitutes a waiver of the argument that the party failed to disclose their expert’s opinions in advance of the hearing.