Destanie Hargrove v. HHS - DTaP, epilepsy and epileptic encephalopathy (2023)

On February 17, 2017, Destanie Hargrove, as mother on behalf of A.F.M., filed a petition alleging that A.F.M. suffered "table injuries, including, but not limited to, severe static epileptic encephalopathy and permanent brain damage" resulting from vaccinations received on May 7, 2014. The vaccinations included diphtheria-tetanus-acellular-pertussis (DTaP), hepatitis B (Hep B), inactivated polio vaccine (IPV), Haemophilus influenzae type b (Hib), and Rotavirus.

Petitioner later narrowed the claim to focus solely on the DTaP vaccine. Respondent argued against compensation.

Special Master Nora Beth Dorsey issued a decision on November 21, 2023, finding that Petitioner failed to prove by a preponderance of the evidence that the DTaP vaccine caused A.F.M.'s condition, and therefore, the petition was dismissed. The Special Master addressed two main issues: whether the event on May 8, 2014, was a seizure or an apparent life-threatening event (ALTE), and whether A.F.M. suffered a Table injury or met the criteria for causation-in-fact.

Regarding the May 8, 2014 event, the Special Master found that the contemporaneous medical records, including those from emergency medical services, the emergency department physician, and nursing staff, indicated that A.F.M. experienced an episode of altered mental status, unresponsiveness, limpness, and difficulty breathing, but not a seizure. The Special Master gave greater weight to these contemporaneous records over later accounts and the opinions of Petitioner's expert, Dr.

Marcel Kinsbourne, who opined it was a seizure. Instead, the Special Master found it more persuasive that the event was an ALTE, consistent with the treating physician's impression of an upper respiratory infection (URI) and possible urinary tract infection (UTI), possibly secondary to reflux or choking.

Petitioner's expert, Dr. Kinsbourne, opined that the DTaP vaccine triggered A.F.M.'s epilepsy through an immune response involving cytokines, leading to seizures and subsequent epileptic encephalopathy.

He argued the May 8 event was an "onset seizure." Respondent's expert, Dr. Gregory Holmes, disagreed, stating the May 8 event was an ALTE and that A.F.M.'s epilepsy was likely caused by an underlying genetic abnormality, not the vaccine.

The Special Master found Dr. Kinsbourne's opinions regarding the May 8 event to be inconsistent and less reliable compared to Dr.

Holmes. The Special Master concluded that Petitioner failed to prove by a preponderance of the evidence that the May 8 event was a seizure, and therefore, the vaccine-related seizure posited by Dr.

Kinsbourne did not occur. Consequently, the Special Master found that Petitioner failed to establish a Table injury, as A.F.M. did not exhibit a significantly decreased level of consciousness for 24 hours within 72 hours of vaccination, as required by the Vaccine Injury Table for encephalopathy.

Regarding the causation-in-fact claim, the Special Master found that because Petitioner failed to prove the May 8 event was a seizure, the causation theory also failed. Even assuming, for the sake of argument, that the May 8 event was a seizure, the Special Master found Petitioner failed to establish all three prongs of the Althen test.

Prong one (medical theory) failed because the proposed cytokine-driven mechanism for afebrile seizures and epilepsy following DTaP vaccination was not supported by sound medical literature specific to the facts of the case, particularly the absence of fever and inflammation. Prong two (logical sequence of cause and effect) failed because there was no evidence of increased cytokine-driven inflammation or excitability after vaccination, and the medical literature did not associate A.F.M.'s type of epilepsy (migrating focal epilepsy of infancy) with vaccinations.

Both experts agreed that A.F.M.'s condition was likely due to an underlying genetic abnormality. Prong three (proximate temporal relationship) failed because A.F.M. was not diagnosed with epilepsy until June 22, 2014, 46 days after vaccination, and there was no evidence of epilepsy or encephalopathy within the 72-hour risk window.

The Special Master found Dr. Holmes' opinions more persuasive, aligning with the medical records and the likely genetic etiology of A.F.M.'s condition.

Ultimately, the petition was denied.