J.W. v. HHS - DTaP, epileptic encephalopathy with residual seizure disorder and global developmental delay (2025)

On August 2, 2019, Michelle Carroll, on behalf of her minor son J.W., filed a petition under the National Vaccine Injury Compensation Program. J.W. received multiple vaccinations on August 3, 2016, and October 11, 2016, including DTaP, pneumococcal conjugate, Hib-PRP-T, IPV, and rotavirus vaccines.

Petitioner alleged that J.W. developed epileptic encephalopathy with residual seizure disorder and global developmental delay as a result of these vaccinations. The parties agreed that J.W.'s diagnosis was epileptic encephalopathy and that it was not a Table injury, meaning Petitioner had to prove causation under the Althen standard.

Petitioner presented expert testimony from pediatric neurologist Yuval Shafrir, M.D., and immunologist Omid Akbari, Ph.D., who opined that the DTaP vaccine could cause inflammation in the brain, leading to seizures and encephalopathy, and that J.W.'s condition was a result of this process. Dr.

Shafrir proposed a challenge-rechallenge theory and suggested that cytokines and autoantibodies could be involved. Dr.

Akbari focused on cytokines and molecular mimicry as potential mechanisms. Petitioner's geneticist, Dmitriy Niyazov, M.D., testified that extensive genetic testing had not identified any genetic cause for J.W.'s condition.

Respondent argued against compensation, presenting expert testimony from pediatric neurologists Eric D. Marsh, M.D., Ph.D., and Christine McCusker, M.D., who opined that J.W.'s condition was not vaccine-related and was more consistent with a presumed genetic epileptic encephalopathy.

Dr. Marsh noted J.W.'s history of microcephaly and developmental delay predating significant seizure activity.

Dr. McCusker critiqued the Petitioner's experts' theories, particularly regarding cytokine-mediated seizures and the lack of evidence for autoimmune involvement or significant fever post-vaccination.

The Special Master found that Petitioner failed to establish a sound and reliable medical theory for causation (Althen Prong One), as the experts' theories were not sufficiently supported by the facts of J.W.'s case, particularly the absence of fever or sickness behaviors. The Special Master also found that Petitioner failed to prove a logical sequence of cause and effect (Althen Prong Two) because J.W.'s clinical course did not align with vaccine causation, and a treating physician, Dr.

Marissa DiGiovine, opined it was highly unlikely the vaccines caused his seizures. Finally, the Special Master determined that Petitioner failed to establish a proximate temporal relationship (Althen Prong Three), as the onset of encephalopathy occurred several months after the vaccinations, approximately five months after the first set and three months after the second set.

Consequently, the petition was denied. Petitioner's counsel was Jessica Wallace of Siri & Glimstad, LLP.

Respondent's counsel was Ryan Daniel Pyles of the U.S. Department of Justice.

The decision was issued by Special Master Nora Beth Dorsey.