Claire Barnette v. HHS - DTaP, Dravet Syndrome (2012)

On December 21, 2006, Claire Barnette, born March 18, 2005, through her parents Karen and Timothy Barnette, filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986. The petition alleged that Claire's receipt of the Pediarix (DTaP/IPV/Hep B), Hib, and Prevnar vaccines on September 19, 2005, at six months of age, triggered her first seizure and significantly aggravated a pre-existing SCN1A gene mutation, leading to Dravet Syndrome with a worse cognitive outcome than would have otherwise occurred.

Petitioners acknowledged that Claire was born with the SCN1A mutation, which they stated arose de novo. They theorized that the vaccination acted as an environmental trigger, causing the onset of her Dravet Syndrome two to three months earlier than it would have without the vaccine, resulting in a worse long-term cognitive outcome.

Claire had developed normally for her first six months and had received the same series of vaccines at her two-month and four-month appointments without reaction. On the night of September 19, 2005, she experienced her first seizure, characterized by rhythmic jerking of her left arm and unresponsiveness.

Her pediatrician noted an "apparent seizure post-vaccinations." Two weeks later, on October 4, 2005, she had a second seizure, was diagnosed with a focal seizure, and began treatment with Trileptal. Further seizures occurred, and by June 2008, she had undergone placement of a vagus nerve stimulator for refractory epilepsy, with records noting developmental delay and speech therapy.

In June 2008, genetic testing revealed a de novo SCN1A mutation, which Athena Diagnostics later reclassified in July 2010 as a "known disease-associated mutation" consistent with Dravet Syndrome. A hearing was held before Special Master Christian J.

Moran on January 19 and 20, 2012. Petitioners presented expert testimony from Dr.

Frances Kendall, a clinical geneticist, who stated that individuals with the same genetic mutation could have a range of clinical outcomes and that vaccines could interact with genetic and environmental factors. They also presented Dr.

James Wheless, a pediatric neurologist and Claire's treating physician, who testified that the McIntosh study supported the conclusion that Claire's first seizure occurred two to three months earlier due to the vaccine, leading to a worse cognitive result. The respondent presented expert testimony from Dr.

Gerald Raymond, a pediatric neurologist and clinical neurogeneticist, and Dr. Max Wiznitzer, a pediatric neurologist.

On September 26, 2012, Special Master Moran denied compensation. He found that while the vaccination likely triggered Claire's first seizure somewhat earlier, the onset at six months was not "significantly earlier" given that it is the typical age of onset for Dravet Syndrome in infants with SCN1A mutations.

More fundamentally, the Special Master concluded that Claire's specific SCN1A mutation predetermined her outcome at the severe end of the Dravet spectrum, and the age of first seizure had no bearing on her long-term cognitive result. He cited the McIntosh study, which found no difference in outcome based on vaccination timing, and the Ragona and Ceulemans articles, which indicated the genetic disorder itself, not the epilepsy onset, was the primary driver of developmental problems.

The Special Master rejected Dr. Wheless's analogy between Dravet Syndrome and infantile spasms, agreeing with Dr.

Wiznitzer that they were different conditions with different prognoses. The Special Master concluded that the "overwhelming evidence presented demonstrates that Claire's specific SCN1A mutation was the sole cause of her disease and that her vaccinations did not result in any worsening of that disease process." Petitioners moved for review.

On March 7, 2013, the United States Court of Federal Claims (Senior Judge Wiese) heard oral argument and affirmed the Special Master's decision. The court found that the Special Master applied the correct legal standard for significant aggravation, that his finding regarding the timing of onset was not arbitrary, and that his refusal to credit Dr.

Wheless's outcome-worsening theory was well-supported by the evidence, particularly the respondent experts' testimony regarding the predictive significance of the mutation's location. The court denied the motion for review and affirmed the Special Master's denial of compensation.