Morgan v. HHS, (Fed. Cl. Spec. Mstr. Dec. 10, 2015) (Gowen, SM)
Entitlement to Compensation – Ulcerative Colitis caused by HPV Vaccination
Petitioner’s expert, her treating physician, opined that non-specific immunomodulatory effects of the Gardasil vaccination could cause ulcerative colitis in susceptible individuals. He explained that although non-specific immunomodulatory effects have not yet been studied in Gardasil recipients, panniculitis has been reported in the literature after HPV vaccine in humans. Current models of ulcerative colitis agree that there is both a genetic and an autoimmune component and that some individuals with genetic risk factors are more susceptible to developing UC. Thus, the expert opined that in a susceptible individual, the autoimmune component may be modulated by Gardasil to create the necessary environment to develop UC. The expert was unable to provide a measure of petitioner’s genetic susceptibility and agreed that there was no evidence indicating any specific environmental trigger for UC, such as a particular vaccine.
The specific medical theory offered was that petitioner had a cytokine response that caused diarrhea within six hours after vaccination, which developed into full-blown UC about a week later through the non-specific, adaptive immune response, within the time frame when he would expect a non-specific cross-reactive immune response.
Respondent’s expert opined that the Gardasil vaccine did not cause or contribute to petitioner’s ulcerative colitis. He stated that the etiology of UC is unknown and there is nothing in the literature that supports the theory of causation or that the Gardasil vaccine, in particular, can cause or contribute to UC. Moreover, he had not seen an uptick in UC cases post-Gardasil. He cited medical literature in support of the contention that vaccines, and the HPV vaccine, in particular, are considered safe in patients with UC. Finally, he argued that Petitioner’s preexisting sacroiliitis was the first manifestation of her UC.
The special master found that Petitioner presented a reasonable theory invoking the role of both the initial innate response to the vaccine antigen and of the adaptive “nonspecific” response. The theory reasonably comported with the potential theories of inflammatory bowel disease and with the notion of non-specific or unintended responses to vaccines discussed in the literature. This was a reasonable scientific explanation of causation given the current state of medical knowledge.
With regard to Althen prong two, the Court found that the theory that an early cytokine response initially caused diarrhea, and a later T-cell mediated response caused bloody stools and full-blown ulcerative colitis, was logical even if it is a sequence “hitherto unproven in medicine.” He rejected the argument that petitioner had a preexisting sacroiliitis that was related to her UC.
Regarding timing, the court found that it was reasonable and consistent with the theory proposed. Petitioner’s diarrhea, originally caused by the innate immune response, failed to resolve and progressed to UC as a result of the later adaptive immune response, which was part of the continuum triggered by the vaccine. This progression occurred about a week later, as evidenced by the onset of bloody stools, which is within the time frame medically expected for a T-cell mediated response.
In closing, the court commented that he was impressed that Petitioner’s treating physician took the time to research and prepare a report supporting her vaccine claim and spend a day in court testifying. The court noted that the treater had the opportunity to view the evolution of the disease and the bowel itself at surgery, and drew upon his immunology training from a transplant residency to develop a reasonable theory to explain how the vaccine could and did trigger the disease.