A.E. v. HHS - DTaP, celiac disease (2017)
Case summary [AI summaries can sometimes make mistakes]
On May 20, 2014, Janelle and Arturo Escalera, on behalf of their minor daughter A.E., filed a petition alleging that the DTaP and HiB vaccines administered on May 20, 2011, caused A.E. to develop celiac disease. The petition was filed under the National Vaccine Injury Compensation Program.
Respondent, the Secretary of Health and Human Services, initially argued that the petitioners had not identified a medical theory connecting the vaccines to the injury and that A.E.'s treating physicians had not identified the vaccinations as causal. Respondent also contended that A.E.'s alleged symptoms onset date was unsupported by the record and that she may have had symptoms prior to vaccination.
After a status conference, the parties were encouraged to settle, but were unable to do so. Petitioners filed an expert report by Dr.
David Axelrod, and Respondent filed a responsive expert report by Dr. Stephen McGeady.
Following further proceedings, both parties agreed to forego an entitlement hearing in favor of a ruling on the existing record. Special Master Lisa Hamilton-Fieldman issued a Ruling on Entitlement on November 23, 2016, finding that Petitioners were entitled to compensation.
Special Master Hamilton-Fieldman accepted Dr. Axelrod's theory that the DTaP and HiB vaccines could trigger celiac disease through mechanisms like molecular mimicry between vaccine components and intestinal enzymes, and that A.E. experienced symptoms consistent with this theory shortly after vaccination.
The case then proceeded to the damages phase. On May 30, 2017, Special Master Herbrina Sanders issued a Decision Awarding Damages based on a stipulation and proffer agreement between the parties.
The award included a lump sum of $38,106.90 for past and future un-reimbursable expenses, a lump sum of $9,966.63 to satisfy a State of Arizona Medicaid lien, and an amount sufficient to purchase an annuity contract for future payments. The total award, including the estimated value of the annuity, amounted to $4,807,353.
Petitioner counsel was Andrew D. Downing of Van Cott & Talamante, PLLC.
Respondent counsel was Christine M. Becer of the United States Department of Justice.
Theory of causation
Petitioners alleged that the DTaP and HiB vaccines administered on May 20, 2011, to minor A.E. caused her to develop celiac disease. Petitioners' expert, Dr. David Axelrod, proposed a two-part theory. First, he theorized that the vaccines caused the release of cytokines, leading to A.E.'s fussiness and rash, and that these cytokines could increase the permeability of the blood-brain barrier. Second, he proposed molecular mimicry, suggesting a homology between vaccine components (pertussis and tetanus toxoid proteins) and antibodies associated with celiac disease, specifically tissue transglutaminase. Dr. Axelrod cited studies on cytokine function, immune complex rashes, and homology between Bordetella pertussis and transglutaminase, and between tetanus toxoid and transglutaminase. Respondent's expert, Dr. Stephen McGeady, challenged Dr. Axelrod's interpretation of the cited literature, questioned the link between the specific vaccines and the alleged symptoms, and argued that celiac disease is not believed to be caused or precipitated by vaccines, citing genetic predisposition and other factors. Special Master Hamilton-Fieldman found Dr. Axelrod's theory persuasive, accepting the proposed mechanisms of cytokine release and molecular mimicry as a plausible explanation for the onset of A.E.'s symptoms and subsequent diagnosis of celiac disease, satisfying the Althen criteria. The case resulted in an entitlement ruling and a subsequent award of $4,807,353, including a lump sum for expenses, satisfaction of a Medicaid lien, and an annuity. Petitioner counsel was Andrew D. Downing, and Respondent counsel was Christine M. Becer. Special Master Hamilton-Fieldman issued the entitlement ruling, and Special Master Herbrina Sanders issued the damages award.
Source PDFs
USCOURTS-cofc-1_14-vv-00431