E.R. v. HHS - DTaP, infantile spasms (2016)
Case summary [AI summaries can sometimes make mistakes]
On July 27, 2009, Dulce and Sean Reilly, parents and natural guardians of E.R., filed a petition under the National Vaccine Injury Compensation Program. They alleged that E.R. suffered from infantile spasms, a seizure disorder, allegedly caused by his DTaP vaccination administered on June 21, 2007.
E.R. was born on December 15, 2006. His parents observed seizure activity beginning the evening of June 21, 2007, described as stiffening, tenseness, unresponsiveness, with facial redness and eyes rolling back.
The episodes were likened to a "touchdown." E.R. received his third dose of DTaP (as part of Pediarix), Prevnar, and Haemophilus influenzae type b vaccine on June 21, 2007. His pediatrician noted contemporaneous concerns about a vaccine reaction, specifically identifying the pertussis component as the likely culprit for neurologic events after immunizations.
An EEG on June 28, 2007, confirmed hypsarrhythmia, and E.R. was started on ACTH. A neurologist, Dr.
Duffy, evaluated E.R. on July 10, 2007, noting that the sudden onset of infantile spasms was unusual unless triggered by an immunization. In July 2010, an MRI revealed focal cortical dysplasia (FCD) in the anterior right temporal lobe, an abnormality with inherent epileptogenic potential.
E.R. underwent surgery for this FCD in October 2010, but his seizures continued, though his parents noted improvements in social engagement. Petitioners' expert, Dr.
Marcel Kinsbourne, proposed a "second hit" theory: the FCD was the first hit (a pre-existing vulnerability), and the acellular pertussis component of the DTaP vaccine was the second hit, triggering clinical epilepsy by lowering the seizure threshold through the release of pro-inflammatory cytokines like interleukin-1 beta. Special Master Janet Hamilton-Fieldman issued a Ruling on Entitlement on May 31, 2016, finding that Petitioners met the three prongs of the Althen test.
She concluded that Dr. Kinsbourne's theory was medically plausible, that the sequence of events and medical observations supported causation, and that the temporal proximity was met.
Special Master Herbrina Sanders issued a Decision Awarding Damages on November 6, 2017. E.R. was awarded a lump sum of $1,268,787.00 for lost earnings, pain and suffering, and Year One life care expenses, plus $130,000.00 for past unreimbursable expenses, and an amount for a life-contingent annuity for future life care.
The total award was $1,398,787.00 plus the annuity. Petitioners' counsel was Edward M.
Kraus. Respondent's counsel was Ryan D.
Pyles.
Theory of causation
On June 21, 2007, E.R., approximately six months old, received the DTaP (Pediarix), Prevnar, and Hib vaccines. That evening, he experienced seizure activity. Petitioners alleged that the DTaP vaccine caused infantile spasms. Special Master Hamilton-Fieldman found entitlement based on a "second hit" theory proposed by Petitioner's expert, Dr. Marcel Kinsbourne. This theory posited that E.R. had a pre-existing focal cortical dysplasia (FCD), identified in July 2010, which represented the first hit, creating an inherent epileptogenic potential. The acellular pertussis component of the DTaP vaccine acted as the second hit, triggering clinical epilepsy by causing the release of pro-inflammatory cytokines, such as IL-1 beta, which lowered the seizure threshold. This theory satisfied the Althen prongs: (1) medical plausibility of the second hit theory connecting FCD and vaccine-induced cytokine release; (2) logical sequence of cause and effect supported by contemporaneous pediatrician notes, Dr. Duffy's observations, and the confirmed FCD; and (3) proximate temporal relationship with seizure onset on the evening of vaccination. Respondent's expert, Dr. Mary Anne Guggenheim, argued against the second hit theory, stating that FCD itself is often the cause of infantile spasms and that there was no evidence linking vaccines to infantile spasms. Special Master Hamilton-Fieldman ruled that while FCDs have inherent epilepsy potential, evidence showed not all FCDs lead to epilepsy, suggesting a trigger is sometimes necessary. She found the pertussis vaccine could act as this trigger. Damages were awarded by Special Master Sanders on November 6, 2017, totaling $1,398,787.00 plus a life-contingent annuity. Petitioners' counsel was Edward M. Kraus; Respondent's counsel was Ryan D. Pyles.
Source PDFs
USCOURTS-cofc-1_09-vv-00489