Rachel Hammitt v. HHS - DTaP, Severe Myoclonic Epilepsy of Infancy (SMEI) (2011)

On March 13, 2007, Scott Hammitt filed a petition for compensation under the National Vaccine Injury Compensation Program on behalf of his daughter, Rachel Hammitt. Rachel, born November 9, 2003, received her second DTaP vaccination, along with IPV, Hepatitis B, Hib, and Pneumococcal Conjugate vaccines, on March 15, 2004, at approximately four months of age.

That evening, Rachel experienced a seizure lasting 45 minutes, characterized by twitching, foaming at the mouth, and a fever of 100.4°F. She was treated with Valium, and the seizure stopped.

Subsequent evaluations noted a "possible adverse event post vaccination" and an "atypical complex febrile seizure." Over the following weeks and months, Rachel experienced further seizures, and by fourteen months of age, signs of delayed verbal and gross motor development were noted. In May 2005, genetic testing revealed a de novo mutation in Rachel's SCN1A gene, which her treating neurologist concluded was suggestive of Severe Myoclonic Epilepsy of Infancy (SMEI).

Mr. Hammitt's theory of causation was that the DTaP vaccination caused a fever, which triggered a prolonged seizure, leading to brain damage, a lowered seizure threshold, and subsequent uncontrollable epilepsy.

He retained Dr. Marcel Kinsbourne to support this theory.

The government, represented by respondent's counsel, countered with expert testimony from Dr. Max Wiznitzer and Dr.

Gerald Raymond, who argued that Rachel's SCN1A gene mutation was the cause of her SMEI. Special Master Golkiewicz issued an initial decision on August 31, 2010, denying compensation, finding that Rachel's SCN1A mutation was the more likely cause of her SMEI.

Mr. Hammitt moved for review, and the Court of Federal Claims remanded the case on December 22, 2010, directing the Special Master to clarify the prima facie case under the Althen test and to apply the "sole substantial factor" standard for the respondent's defense.

On remand, the Special Master again denied compensation on March 4, 2011. The Special Master found that Mr.

Hammitt failed to establish a prima facie case, specifically prong two of the Althen test, because there was insufficient evidence that Rachel's initial seizure caused brain damage, which was a critical element of Dr. Kinsbourne's theory.

The Special Master also noted that unlike previous cases where genetic predisposition was speculative, Rachel's confirmed de novo SCN1A mutation, particularly its location and association with SMEI, provided concrete evidence of an alternative cause. The government's expert, Dr.

Raymond, testified that these genetic factors cumulatively demonstrated that Rachel's SCN1A gene mutation caused her SMEI, and this testimony went essentially unrebutted by Dr. Kinsbourne, who lacked expertise in genetics.

Mr. Hammitt again moved for review, and the Court of Federal Claims, in an opinion issued July 8, 2011, affirmed the Special Master's decision.

The court found that the Special Master correctly applied the Althen test, did not require direct evidence of brain damage, and properly considered the evidence. The court also affirmed the denial of additional evidence on remand.

The court concluded that Mr. Hammitt failed to establish a prima facie case because the evidence did not demonstrate a logical sequence of cause and effect linking the DTaP vaccine to brain damage.

Furthermore, the court agreed with the Special Master that Rachel's SCN1A gene mutation was the sole substantial factor responsible for her SMEI. Petitioner counsel was not named in the provided text.

Respondent counsel was not named in the provided text. The outcome was denied compensation.