Allen v. HHS, (Fed. Cl. Spec. Mstr. Sep. 26, 2015) (Vowell, SM)
The Court, in one of its last decisions on the bench, wrote a 115-page opinion in this former OAP case. The theory of the case was that 1) the child had an underlying mitochondrial disorder that made her vulnerable to the inflammatory effects of the MMR vaccine; 2) the vaccine, which constituted an immunological stressor, overwhelmed the child’s already impaired mitochondrial function and caused extensive cell death in her brain; 3) resulting in an acute regression which manifested as mitochondrial autism.
In addition to vaccine causation, the parties disputed 1) the state of the child’s health and development prior to the MMR vaccine, 2) whether she suffered a developmental regression after her receipt of MMR, and, if so, 3) when the regression occurred; and 4) whether the child had a mitochondrial disease.
Respondent’s experts opined that the child did not have a mitochondrial abnormality or suffer a rapid regression, rather, she exhibited signs of autism prior to vaccination and followed a typical course thereafter. Thus, the MMR vaccine did not aggravate an underlying condition or cause her to develop ASD.
The Court held that the child had symptoms of ASD prior to the administration of the MMR vaccination. Further, the child did not experience an abrupt deterioration of her development after the MMR vaccination. Rather, her developmental course was typical of autistic regression beginning with delayed speech prior to vaccination and continuing with a gradual deterioration of social skills and other behaviors.
Additionally, preponderant evidence did not support a finding that the child had a mitochondrial disease, disorder, or dysfunction, a necessary prerequisite to the medical theory.
With regard to prong one, the Court held that Petitioners failed to present preponderant evidence that that the MMR vaccination can cause regression and “mitochondrial autism” in children with a mitochondrial disease, disorder, or dysfunction; that the evidence on this component of Petitioners’ theory was too scant to be reliable. I.e., there was no credible evidence that inflammation caused by vaccination plays a role in the development of regression and/or mitochondrial autism in children with mitochondrial dysfunction.
Prong 2 failed due to the factual findings described above.
Regarding prong 3, the Court found that the proposed temporal interval was unsupported by the literature, and also that the onset did not occur in that time frame in any event.
The Court also applied a significant aggravation analysis, finding that the child’s preexisting autism was not worse after the vaccination but instead followed a normal course.