J.M.G. v. HHS - DTaP, macrocephaly secondary to enlarged extra-axial cerebral spinal fluid space and developmental delay (2022)

On June 6, 2017, M.G., proceeding pro se as parent and natural guardian of J.M.G., filed a petition under the National Vaccine Injury Program. The petition alleged that J.M.G. suffered a severe adverse reaction from pediatric vaccines, specifically the hepatitis B, DTaP, rotavirus, Hib, PCV 13, and IPV vaccines administered on May 13, 2014, and July 16, 2014.

The petitioner claimed J.M.G. experienced extremely rapid head growth, hydrocephalus or macrocephaly, and global developmental delay. The respondent was the Secretary of Health and Human Services.

The medical records indicated that J.M.G. was born with a head circumference above the 90th percentile, and his length and weight were also high on the growth curves. No prenatal or labor complications were noted.

At his two-month visit on May 13, 2014, J.M.G. received his first doses of the listed vaccines, and no adverse reaction was recorded. His head circumference was in the 75th percentile at this visit.

At his four-month visit on July 16, 2014, he received the second doses of these vaccines, and his head circumference was above the 95th percentile. A cranial sonogram on July 22, 2014, showed an extra-axial fluid collection and prominent ventricles.

A neurological evaluation by Dr. Harriet Cokely on July 30, 2014, noted the escalating head circumference and reviewed the family history of large head circumferences.

Dr. Cokely opined that the condition was likely genetic, involving delayed absorption of spinal fluid in the subarachnoid space.

Subsequent imaging consistently showed stable prominent extra-axial spaces or benign external hydrocephalus/benign macrocephaly of infancy. No treating physician connected the vaccines to J.M.G.'s condition.

J.M.G. later presented with macrocephaly, diffuse hypotonia, expressive language and motor delays, and school records indicated eligibility for autism spectrum disorder, speech/language impairment, and occupational therapy needs. The petitioner stated that after the four-month visit, J.M.G. seemed less alert and missed developmental milestones for rolling, crawling, walking, and speech.

Petitioner's experts were Cathy Buckley, Ph.D., and Dr. Harumi Harum.

Dr. Buckley proposed that aluminum-containing vaccines triggered acute brain inflammation and rapid head growth through microglial activation.

However, she did not file a curriculum vitae, was not shown to be a medical doctor or neurologist, and her proposed mechanism was not supported by reliable medical evidence. Dr.

Harum proposed that vaccine-triggered inflammation or small-vessel vasculitis at the arachnoid villi impaired cerebrospinal fluid absorption, causing hydrocephalus and developmental injury. The Special Master found that Dr.

Harum did not cite medical record evidence showing high-pressure hydrocephalus, vasculitis, angiitis, or ischemic white-matter injury. The Special Master also noted that Dr.

Harum's expert reports had previously been found unpersuasive and conclusory in other cases. Respondent's experts, Dr.

Peter Bingham and Dr. Joseph Blattman, were credited.

Dr. Bingham's opinion aligned with the treating neurologist's diagnosis of benign external hydrocephalus and noted that such conditions often run in families and can be associated with neurodevelopmental difficulties.

Dr. Blattman disputed the immunological theories presented by petitioner's experts, stating there was no published literature supporting the concept that aluminum adjuvants trigger CNS inflammation or that they contribute to intracranial inflammation or rapid head circumference increase.

The literature cited by respondent supported familial predisposition in benign external hydrocephalus and did not associate vaccines with the condition. Special Master Nora Beth Dorsey dismissed the case on March 25, 2022, for failure to prosecute and insufficient proof, noting that the petitioner had repeatedly failed to file ordered updated records and expert reports despite numerous extensions.

In the alternative, ruling on the merits, the Special Master found that the petitioner failed all three prongs of the Althen causation analysis: no reliable theory that vaccines cause macrocephaly/hydrocephalus or developmental delay, no logical sequence showing vaccines caused J.M.G.'s condition, and no medically acceptable onset interval. The Special Master denied petitioner's motions for recusal and deadline extensions.

Entitlement to compensation was denied, and no award was granted.