A.A. v. HHS - DTaP, seizure disorder (2021)
Case summary [AI summaries can sometimes make mistakes]
On June 12, 2015, Kristine and Matthew Akers filed a petition under the National Vaccine Injury Compensation Program on behalf of their daughter, A.A., alleging that the DTaP, hepatitis B, IPV, Hib, rotavirus, and pneumococcal conjugate vaccines administered on December 10, 2012, caused or substantially contributed to her seizure disorder. A.A. was born in August 2012 and experienced feeding issues and reflux as a newborn, but was developing normally by her two-month visit.
Following her four-month vaccinations, her parents observed seizure-like episodes on December 12-13, 2012, and sought medical attention on December 15, 2012. Her condition evolved into infantile spasms, later diagnosed as West syndrome and a severe seizure disorder.
Initial MRIs of A.A.'s brain were unremarkable. However, as she grew older and underwent more advanced imaging, including MRIs, PET scans, electrocorticography (ECoG), and stereo-EEG (sEEG), physicians identified extensive focal cortical dysplasia (FCD) and related malformations.
A potential FCD focus was identified in the right high anterior parietal region in October 2016. A first surgical resection was performed on June 23, 2017, followed by a second resection on January 8, 2019, after which A.A. became seizure-free and showed some cognitive improvement.
The petitioners initially proposed a genetic susceptibility theory involving the EFCH1 gene, supported by Dr. Richard Boles, but this theory was withdrawn.
Their remaining experts, including neurologists Dr. Marcel Kinsbourne and Dr.
M. Eric Gershwin, argued that FCD creates a hyperexcitable neural network and that vaccination could act as an immune or cytokine trigger for seizure onset, potentially worsening the outcome with earlier onset.
The respondent's experts, including neurologists Dr. Gerald Raymond, Dr.
James McCusker, and Dr. Michael Kohrman, contended that A.A.'s extensive FCD was sufficient to cause her epilepsy without a vaccine trigger.
Special Master Thomas L. Gowen denied the petition on July 6, 2021.
He found that while the temporal association between vaccination and seizure onset was understandable, the preponderant evidence indicated that A.A.'s extensive FCD was the cause of her seizure disorder. He noted that A.A.'s treating neurologist, Dr.
Arndt, had suspected FCD early, and subsequent imaging and surgeries confirmed multiple foci of cortical dysplasia, with seizure freedom after resection supporting a structural cause. The Special Master concluded that the petitioners failed to prove either causation-in-fact or significant aggravation, leading to the dismissal of the claim.
The public decision does not detail the specific onset of symptoms beyond the initial seizure-like episodes, the specific diagnostic tests used beyond imaging and EEG, or the names of all treating physicians beyond Dr. Arndt.
The decision does not specify the exact dollar amount or annuity terms as compensation was denied.
Theory of causation
Petitioners alleged that DTaP, Hep B, IPV, Hib, rotavirus, and PCV vaccines administered on December 10, 2012, to four-month-old A.A. caused or substantially contributed to her seizure disorder, which began with seizure-like episodes on December 12-13, 2012, and evolved into infantile spasms/West syndrome. The petitioners' final theory, supported by experts Dr. Marcel Kinsbourne and Dr. M. Eric Gershwin, posited that A.A.'s underlying focal cortical dysplasia (FCD) created a hyperexcitable neural network, lowering her seizure threshold, and that the vaccines, particularly DTaP, acted as an immune or cytokine trigger, precipitating earlier seizure onset and worsening sequelae. An earlier genetic susceptibility theory involving the EFCH1 gene, proposed by Dr. Richard Boles, was withdrawn. The respondent's experts, including Dr. Gerald Raymond, Dr. James McCusker, and Dr. Michael Kohrman, argued that the extensive FCD identified in A.A.'s brain was intrinsically epileptogenic and sufficient to cause her epilepsy without a vaccine trigger. Key evidence included initial MRIs that were unremarkable, but later, more sensitive imaging (3T MRI, PET, ECoG, sEEG) revealed extensive FCD, heterotopic neurons, and multiple right-hemisphere foci. A second surgical resection on January 8, 2019, resulted in seizure freedom. Special Master Thomas L. Gowen denied the claim on July 6, 2021, finding that the preponderant evidence indicated FCD was the cause and that temporal association alone was insufficient to prove Althen causation or Loving significant aggravation. Attorneys for petitioners were William E. Cochran, Jr., and Michael McLaren of Black McLaren et al., PC. Attorney for respondent was Voris E. Johnson, with Ilene C. Albala and Justine E. Walters presenting the case.
Source PDFs
USCOURTS-cofc-1_15-vv-00597