Agnew v. HHS, (Fed. Cl. Spec. Mstr. Mar. 30, 2016) (Millman, SM)
Petitioner’s theory was that FluMist, which ordinarily causes a subclinical infection, activated his immune system which was misdirected into entering his liver. Within 10 days of vaccination, he had abdominal pain, nausea, increasing yellow color of his skin, a rise in enzymes showing destruction of hepatic cells, overwhelming liver failure (hepatitis), necessitating a liver transplant. Processes, including molecular mimicry, innocent bystander injury, and polyclonal expansion of the immune system, caused his immune system to be not only directed against FluMist vaccine but also against his liver.
Petitioner’s expert explained he was not describing typical autoimmune hepatitis, but rather a vaccine immune-activated induced reaction to a live attenuated vaccine, generating cell-mediated injury. By analogy, the same process which could result from live influenza infection.
Respondent’s expert testified it was possible that FluMist escaped the mucosa, but if it had attacked the liver, there should have been evidence of it in the liver. Only very mild inflammatory periportal infiltrate was seen, while he would have expected to see inflammatory mediators such as complement. Petitioner’s expert countered that the presence of inflammatory cells is not required or characteristic of apoptotic cell death which natural killer cells or CD-8 cells mediate.
Important for practitioners to note is the following: Petitioner’s expert “admitted there is no direct proof of this process, but he testified that he and other doctors use deductive reasoning based on their education and experience to reach an understanding, imperfect though it may be, of how the immune system works and how it malfunctions.” This is a good counter to the Daubert factor that asks for evidence showing that a particular process actually took place in the person.
The special master found the Petitioner’s theory credible and found in favor of Petitioners.