N.C. v. HHS - DTaP, sudden unexplained death (2025)

On May 9, 2019, Nicholas and Marjorie Catone, parents of N.C., filed a petition under the National Childhood Vaccine Injury Act alleging that their son's death on May 12, 2017, was caused by his DTaP vaccination administered on April 25, 2017. N.C., who was approximately 20 months old at the time of his death, was found unresponsive in his crib.

An autopsy determined the cause of death to be sudden unexplained death (SUDC), a diagnosis of exclusion. The parents contended that the DTaP vaccine initiated a hyperimmune reaction leading to a terminal seizure.

They presented expert testimony from pathologist Steven Rostad, M.D., and immunologist Omid Akbari, Ph.D. Dr.

Rostad opined that N.C.'s death was caused by cerebral edema with tonsillar and uncal herniation resulting from a suspected seizure, with a hippocampal malformation significantly contributing. He theorized that the DTaP vaccination initiated a chain of events leading to his death, potentially amplified by a mild viral upper respiratory infection.

Dr. Akbari posited that the vaccine components stimulated N.C.'s immune system, leading to an autoimmune reaction and eventual death, and also suggested that aluminum adjuvants could cross the blood-brain barrier and incite inflammatory responses.

Respondent, the Secretary of Health and Human Services, opposed the petition, arguing that the evidence did not support a causal link between the vaccination and N.C.'s death and that the death was appropriately categorized as SUDC. Respondent presented expert reports from pediatric immunologist Christine McCusker, M.D., pediatric neurologist Gregory L.

Holmes, M.D., and pathologist Brent Harris, M.D., Ph.D. These experts argued that the petitioners' theory lacked sufficient scientific and medical support, that the autopsy findings were consistent with SUDC, and that the evidence did not support a causal link between the vaccination and the death.

They contended that the alleged seizure on May 7, 2017, was not clearly a seizure and that the timing of N.C.'s death was not compatible with the petitioners' theory. Special Master Daniel T.

Horner reviewed the extensive record, including numerous expert reports and medical literature. He found that the petitioners failed to establish a causal link between the vaccination and N.C.'s death under the Althen test, which requires a medical theory of causation, a logical sequence of cause and effect, and a proximate temporal relationship.

The Special Master concluded that the evidence preponderated in favor of a finding that N.C.'s death remained unexplained and constituted SUDC. Therefore, the petition was denied, and no compensation was awarded.

Petitioner counsel was Jessica Wallace and Siri & Glimstad, LLP. Respondent counsel was Catherine Elizabeth Stolar, U.S.

Department of Justice.