L.Z. v. HHS - DTaP, seizure disorder (2019)

Nicholas Zumwalt, on behalf of his minor son L.Z., filed a petition on August 12, 2016, seeking compensation under the National Vaccine Injury Compensation Program. The petition alleged that L.Z.'s seizure disorder was caused by vaccines administered on March 24, 2014, including ActHib 4, Prevnar 13, Pediarix (which contains DTaP, Hepatitis B, and IPV), and RotaTeq.

L.Z. was born prematurely and had some developmental concerns noted prior to vaccination, including delays in social interaction and eye contact, head lag, increased tone in his lower extremities, and tight hands and fists. Following vaccination, L.Z. experienced seizure-like activity eight days later, on April 1, 2014, leading to hospitalization and a diagnosis of infantile epileptic encephalopathy.

Petitioner's experts, Dr. David Siegler and Dr.

Lawrence Steinman, proposed theories of causation involving the pertussis toxin in the DTaP vaccine and potential inflammatory cascades. Dr.

Siegler opined that the vaccines triggered a neurologic inflammatory cascade. Dr.

Steinman theorized that the pertussis toxin in the DTaP vaccine could cause seizures through an enzymatic process called ADP-ribosylation, and also pointed to potential issues with the RotaTeq and Hib vaccines based on package inserts. Respondent's expert, Dr.

John Zempel, argued that L.Z. likely had pre-existing neurological abnormalities and that Dr. Steinman's vaccine causation theory was unsupported by medical literature.

The Special Master, Brian H. Corcoran, denied entitlement on March 21, 2019.

He found that Petitioner failed to establish a reliable medical theory connecting the vaccines to the seizure disorder (Althen Prong One) and that the evidence did not support the conclusion that the vaccines caused the injury (Althen Prong Two). The Special Master noted that the DTaP theory relied on suppositions not fully supported by literature, that the RotaTeq and Hib theories had even less support, and that the alum adjuvant theory was deficient.

He also found significant factual gaps in the medical record and that L.Z. did not experience a fever with the initial seizure onset. The Special Master gave less weight to Dr.

Siegler's opinion due to its late timing and the lack of contemporaneous support from other treaters, and found Dr. Zempel's testimony persuasive that the cause was likely idiopathic.

The United States Court of Federal Claims, in a decision by Judge Lydia Kay Griggsby on October 29, 2019, affirmed the Special Master's decision, denying the petitioner's motion for review. The court agreed that the special master properly analyzed the theory of causation, reasonably weighed the testimony of Dr.

Siegler, and did not substitute his own medical judgment. No compensation was awarded.