E.O., III v. HHS - DTaP, Dravet syndrome; chronic complex partial seizure disorder; encephalopathy characterized by speech delay (2017)
Case summary [AI summaries can sometimes make mistakes]
On June 25, 2010, Laura and Eddie Oliver, Jr. (petitioners) filed a petition for compensation on behalf of their son, E.O. III (E.O.), alleging that the Diphtheria-Tetanus-acellular Pertussis (DTaP), Hepatitis B (Hep B), Inactivated Poliovirus (IPV), Pneumococcal conjugate (PCV), and Rotavirus vaccines E.O. received on April 9, 2009, caused him to develop a fever, febrile seizures, and ultimately a chronic complex partial seizure disorder known as Dravet syndrome.
E.O. was six months old at the time of vaccination. His mother reported that he had a seizure on the night of vaccination.
Medical records indicated a fever and a diagnosis of a febrile seizure. E.O. had no further seizures for two months, but then began experiencing more frequent and prolonged seizures.
He was diagnosed with focal epilepsy, then intractable epilepsy, and finally, at 21 months old, with Dravet syndrome, which was attributed to a de novo mutation in his SCN1A gene. Petitioners' expert, Dr.
Yuval Shafrir, proposed two theories of causation: a 'second hit' theory where the vaccination acted as an environmental trigger for the pre-existing genetic mutation, and an immune-mediated response theory involving molecular mimicry. Respondent's experts, Dr.
Gerald Raymond and Dr. Rajesh Sachdeo, opined that E.O.'s SCN1A gene mutation was the sole cause of his Dravet syndrome and that the vaccinations did not cause or aggravate his condition.
The Chief Special Master agreed with the respondent's experts, finding that petitioners failed to establish a reliable medical theory of causation (Althen Prong One), a logical sequence of cause and effect (Althen Prong Two), or a proximate temporal relationship linking the vaccines to Dravet syndrome (Althen Prong Three). The Chief Special Master also found that the petitioners failed to prove significant aggravation of a pre-existing condition.
The court affirmed this decision, noting that the Special Master's weighing of the expert testimony and her conclusion that the SCN1A mutation was the cause of E.O.'s condition were well-supported by the record and entitled to deference. The petition was denied.
Petitioners sought review of the Special Master's decision, arguing that the Special Master erred in rejecting their expert's opinion, crediting the government's experts, and deciding the case without an evidentiary hearing. The reviewing court found that the Special Master's decision was not arbitrary, capricious, or contrary to law, and that she acted within her discretion in deciding the case on the written record.
The motion for review was denied and the decision was sustained.
Theory of causation
Petitioners alleged that the DTaP, Hep B, IPV, PCV, and Rotavirus vaccines administered on April 9, 2009, caused E.O. III to develop Dravet syndrome. Petitioners' expert, Dr. Yuval Shafrir, proposed two theories: a 'second hit' theory where vaccination acted as an environmental trigger for E.O.'s SCN1A gene mutation, and an immune-mediated response theory involving molecular mimicry. Respondent's experts, Dr. Gerald Raymond and Dr. Rajesh Sachdeo, opined that E.O.'s SCN1A gene mutation was the sole cause of his Dravet syndrome and that the vaccines did not cause or aggravate his condition. The Chief Special Master found that petitioners failed to establish a reliable medical theory of causation, a logical sequence of cause and effect, or a proximate temporal relationship. The Special Master also found that the SCN1A gene mutation was the sole cause of E.O.'s condition, and that the vaccines did not significantly aggravate his pre-existing condition. The Special Master's decision was affirmed on review. Petitioners were represented by Clifford J. Shoemaker. Respondent was represented by Lara A. Englund. The decision was issued by Chief Special Master Nora Beth Dorsey and affirmed by Judge Elaine D. Kaplan. Compensation was denied.
Source PDFs
USCOURTS-cofc-1_10-vv-00394