Javier Colon v. HHS - MMR, alleged vaccine reactions, reflux/GI issues, rash, seizures/spasms, microcephaly, developmental delay, cerebral palsy, IQSEC2 neurogenetic condition (2020)
Case summary [AI summaries can sometimes make mistakes]
On January 11, 2019, Javier Colon filed a petition under the National Childhood Vaccine Injury Act on behalf of his minor child, S.C. The petition alleged that S.C. suffered adverse reactions, gastrointestinal and digestive issues, reflux, skin rashes, seizures, and spasms following a series of childhood vaccinations administered between January 11, 2016, and January 4, 2017.
The vaccines identified were diphtheria-tetanus-acellular pertussis (DTaP), hepatitis B (Hep B), rotavirus, haemophilus influenzae type b (Hib), inactivated polio (IPV), pneumococcal, measles-mumps-rubella (MMR), hepatitis A (Hep A), and influenza (flu). Respondent was the Secretary of Health and Human Services.
S.C. was born on November 9, 2015. Medical records indicated prenatal findings of large ventricles on a six-month ultrasound.
Microcephaly was present at birth, and physicians initially suspected congenital cytomegalovirus infection or a first-trimester intrauterine insult. S.C. first presented with possible gastroesophageal reflux or feeding problems at approximately nine weeks of age on January 15, 2016.
A gastrostomy tube was inserted on December 13, 2016, due to continued feeding difficulties. Rash was first documented at a well-child visit on March 9, 2016, described as chronic and worsening seborrhea.
This condition later appeared to resolve when S.C.'s mother reduced her nut intake, suggesting an allergy. Focal seizures were questioned on June 17, 2016, based on left-leg activity.
Generalized seizures were reported on July 27, 2016, accompanied by altered consciousness, drooling, lip smacking, and unresponsiveness. An EEG showed hypsarrhythmia, consistent with S.C.'s microcephaly.
S.C. was diagnosed with cerebral palsy by Dr. Susan L.
Hyman, who attributed his oral-motor coordination issues requiring a gastrostomy tube, cortical visual use, constipation, and growth delay to cerebral palsy and its underlying causes. A neurogeneticist evaluated S.C. on January 29, 2018, concluding that his medical history, including microcephaly, severe developmental delays, infantile spasms, failure to thrive, gastrostomy-tube dependence, obstructive sleep apnea, and brain malformations, had a genetic cause.
S.C. was later found to have a maternally inherited IQSEC2 gene variant, considered likely pathogenic and a candidate gene for his condition. Petitioner's parents believed there was a temporal association between vaccinations and S.C.'s symptoms.
A nurse-practitioner provided a letter on July 11, 2018, recommending that S.C. avoid future vaccinations due to his genetic disorder and parental reports of adverse vaccine reactions. However, Special Master Daniel T.
Horner found this letter inadequate to support causation. The letter's rationale focused on the minimal additional risk of avoiding future vaccines, as S.C. was already fully vaccinated, and did not state that any vaccine caused or contributed to his condition.
Dr. David Bearden's notes, referenced in the letter, did not list vaccine reactions as part of his impression or vaccine avoidance as a recommendation.
Respondent recommended against compensation in an August 22, 2019 Rule 4(c) report. Petitioner was granted multiple extensions, totaling eleven months, to file an expert report.
Petitioner's counsel reported that potential experts were unable to submit a report. Following an order to show cause and a final extension, petitioner still could not file an expert report by the October 19, 2020 deadline.
On October 21, 2020, Special Master Horner dismissed the petition for insufficient proof and failure to prosecute. He found that no Vaccine Table injury had been alleged or shown, and the medical records did not contain preponderant evidence connecting S.C.'s conditions to vaccination.
None of S.C.'s treating physicians opined that his symptoms were vaccine-caused or vaccine-aggravated; instead, the records pointed to more compelling explanations, including congenital genetic causes. The Special Master noted that temporal association alone is insufficient to satisfy the Vaccine Act without supporting medical records or expert opinion.
Petitioner was represented by Michael A. London of Douglas & London, P.C.
No compensation was awarded.
Theory of causation
Petitioner alleged that DTaP, Hep B, rotavirus, Hib, IPV, and pneumococcal vaccines administered on January 11, 2016, and subsequent DTaP/Hep B/rotavirus/IPV/pneumococcal vaccines on March 29 and June 6, 2016, MMR/Hep A/pneumococcal on November 16, 2016, and influenza vaccines on December 2, 2016, and January 4, 2017, caused adverse reactions, GI/digestive issues, reflux, rashes, seizures/spasms, microcephaly, developmental delay, and a neurogenetic condition (IQSEC2 gene variant). The petition was DISMISSED. The theory relied on parental temporal association, but no Table injury was alleged or found, and no expert report supported causation under Althen. Key evidence included prenatal large ventricles, microcephaly at birth, suspected congenital CMV or intrauterine insult, feeding/reflux by January 15, 2016, G-tube insertion on December 13, 2016, rash documented March 9, 2016 and attributed to nut allergy, questioned focal seizures on June 17, 2016, generalized seizures on July 27, 2016, abnormal EEG with hypsarrhythmia consistent with microcephaly, cerebral palsy/global delay diagnosis, and a maternally inherited IQSEC2 variant considered likely pathogenic. A nurse-practitioner's vaccine-avoidance letter did not opine causation. Special Master Daniel T. Horner dismissed the case on October 21, 2020, for insufficient proof and failure to prosecute after petitioner could not secure an expert report despite multiple extensions. Petitioner's attorney was Michael A. London of Douglas & London, P.C. No award was made.
Source PDFs
USCOURTS-cofc-1_19-vv-00057