LISA FAUP, on behalf of A.F., a minor v. HHS - DTaP, systemic juvenile idiopathic arthritis (2020)
Case summary [AI summaries can sometimes make mistakes]
On February 9, 2012, Lisa Faup, on behalf of her minor daughter A.F., filed a petition alleging that the Diphtheria-Tetanus-acellular-Pertussis (DTaP) and inactivated polio (IP) vaccines administered on March 13, 2009, caused A.F. to develop systemic juvenile idiopathic arthritis (sJIA). A.F. was approximately five years old at the time of vaccination.
Following vaccination, A.F. developed a rash, fever, and joint pain, leading to a diagnosis of sJIA. The petition was amended on October 5, 2012, to specifically allege sJIA as the vaccine-related injury.
The case proceeded as an off-Table claim, requiring proof of causation-in-fact. Petitioner's counsel was Sylvia Chin-Caplan.
Respondent's counsel was Jennifer L. Reynaud.
Special Master Herbrina Sanders presided over the case. An entitlement hearing was held on March 13-14, 2018.
Petitioner's experts, Dr. Robert Sundel (pediatric rheumatologist) and Michael Gurish, Ph.D. (immunochemist), proposed a theory that the aluminum adjuvants in the DTaP and IP vaccines triggered A.F.'s autoinflammatory condition, likening it to a "cytokine storm" or a "bubbling pot" overflowing due to multiple factors, including genetic predisposition and prior ear infection treated with amoxicillin.
They argued that the rapid onset of symptoms was consistent with an innate immune system response to the adjuvant. Respondent's experts, Dr.
Carlos Rose (pediatric rheumatologist) and Dr. J.
Lindsay Whitton (immunologist), argued that A.F.'s sJIA was more likely caused by a viral infection, given her genetic predisposition and the nature of autoinflammatory diseases. They critiqued the Petitioner's experts' reliance on the Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants (ASIA) theory, citing its vague diagnostic criteria, lack of scientific support, and over-inclusiveness.
They contended that the effects of aluminum adjuvants are localized and short-lived, and that viral infections are more likely to cause persistent inflammation and conditions like sJIA and macrophage activation syndrome (MAS), which A.F. also experienced. The Special Master found that Petitioner failed to establish a credible medical theory linking the vaccines to A.F.'s sJIA, primarily due to the unreliability and flaws of the ASIA theory and its variants, which had been rejected in prior cases.
The Special Master also found that Petitioner failed to demonstrate a logical sequence of cause and effect showing the vaccination was the reason for the injury, noting that A.F. was genetically predisposed to sJIA and MAS, and that the evidence more strongly supported a viral infection as the cause. The proximate temporal relationship was also questioned, with the Special Master finding the timeframe proposed by Respondent's experts more appropriate.
Therefore, the petition was denied, and the case was dismissed.
Theory of causation
Petitioner Lisa Faup, on behalf of minor A.F., alleged that the DTaP and IP vaccines received on March 13, 2009, caused A.F. to develop systemic juvenile idiopathic arthritis (sJIA). A.F. was approximately five years old. The claim was an off-Table, requiring proof of causation-in-fact. Petitioner's experts, Dr. Robert Sundel and Dr. Michael Gurish, proposed a theory that aluminum adjuvants in the vaccines triggered A.F.'s autoinflammatory condition, likening it to a "cytokine storm" or "bubbling pot" effect, influenced by genetic predisposition and a prior ear infection. They argued the rapid onset was consistent with an innate immune response to the adjuvant, aligning with the ASIA (Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants) hypothesis, though Dr. Sundel distanced himself from the ASIA acronym. Respondent's experts, Dr. Carlos Rose and Dr. J. Lindsay Whitton, countered that a viral infection was the more likely cause, citing A.F.'s genetic predisposition to sJIA and MAS, and the transient nature of adjuvant effects versus persistent viral triggers. They criticized the ASIA theory for its vague and flawed diagnostic criteria. Special Master Herbrina Sanders denied the petition, finding Petitioner failed to establish a credible medical theory under the first prong of Althen, as the ASIA-related theory was deemed unreliable and unproven. The Special Master also found Petitioner failed to demonstrate causation under the second prong, as the evidence favored a viral infection as the cause, and the third prong regarding proximate temporal relationship was not met. The petition was denied.
Source PDFs
USCOURTS-cofc-1_12-vv-00087