H.E.F. v. HHS - DTaP, seizures, brain damage, and developmental delay, or in the alternative, “significantly aggravated . . . an underlying genetic pre-disposition.” (2016)

On October 15, 2010, Kimberly and Tyson Faoro filed a petition under the National Vaccine Injury Compensation Program on behalf of their daughter, H.E.F. They alleged that the DTaP, hepatitis B, IPV, Hib, pneumococcal conjugate, and rotavirus vaccines H.E.F. received on December 28, 2007, caused her to develop seizures, brain damage, and developmental delay, or alternatively, significantly aggravated an underlying genetic predisposition.

H.E.F. was born on August 28, 2007, after an unremarkable neonatal course. She received her two-month vaccines on October 22, 2007, experiencing fever, vomiting, and diarrhea, but no seizures.

On December 28, 2007, at her four-month visit, she received Pediarix (DTaP-HepB-IPV), Hib, Prevnar, and RotaTeq. Approximately six to seven hours later, she experienced shaking of her right arm and leg and temporary loss of use of her right arm.

An emergency department visit revealed a temperature of 99.4 degrees, and normal CT scan, blood count, and electrolytes. She was discharged but experienced another seizure-like episode around 2:00 a.m. the next morning, involving her left side, followed by several hours of flaccidity.

At Blank Children's Hospital, a diagnosis of complex febrile seizures was made by Dr. Duangchai Narawong.

Over the following months and years, H.E.F. experienced recurrent prolonged seizures, often associated with fever or illness, and was eventually diagnosed with Dravet syndrome. Crucially, genetic testing revealed that H.E.F. carried an SCN1A mutation associated with Dravet syndrome.

Her mother carried the same mutation but was asymptomatic, a key difference from prior SCN1A cases in the program. Petitioners argued that the mutation created susceptibility, and the vaccines acted as an environmental "second hit" that triggered Dravet syndrome and worsened its course.

Their experts included geneticist Dr. Barbara Burton and pediatric neurologist Dr.

Marcel Kinsbourne. Respondent's experts, epilepsy specialist Dr.

Rajesh Sachdeo and pediatric neurologist/geneticist Dr. Gerald Raymond, argued that the SCN1A mutation itself caused the Dravet syndrome, and that mosaicism explained the mother's asymptomatic status.

Chief Special Master Nora Beth Dorsey denied entitlement on January 29, 2016. She found that while the December 2007 vaccinations may have caused a low-grade fever or triggered the first seizure, neither the initial seizure nor the vaccinations caused or significantly aggravated H.E.F.'s Dravet syndrome and neurological complications.

The decision credited respondent's evidence that H.E.F.'s clinical course was consistent with Dravet syndrome caused by her SCN1A mutation, and that current medical literature did not support the claim that vaccination worsened prognosis or severity in children with Dravet syndrome. Senior Judge Loren A.

Smith denied petitioners' motion for review on April 26, 2016, holding that the special master had not increased petitioners' burden under Althen or Loving and had properly treated the SCN1A mutation as the unrelated cause of H.E.F.'s condition. The petition was dismissed.