VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-00057
Package ID: USCOURTS-cofc-1_19-vv-00057
Petitioner: S.C.
Filed: 2019-01-11
Decided: 2020-10-21
Vaccine: DTaP; hepatitis B; rotavirus; Hib; IPV; pneumococcal; MMR; hepatitis A; influenza
Vaccination date: 2016-01-11; 2016-03-29; 2016-06-06; 2016-11-16; 2016-12-02; 2017-01-04
Condition: alleged vaccine reactions, reflux/GI issues, rash, seizures/spasms, microcephaly, developmental delay, cerebral palsy, IQSEC2 neurogenetic condition
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
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 field:
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.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_19-vv-00057-0
Date issued/filed: 2020-11-13
Pages: 5
Docket text: PUBLIC DECISION (Originally filed: 10/21/2020) regarding 27 DECISION of Special Master. Signed by Special Master Daniel T. Horner. (tkp) Service on parties made.
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Case 1:19-vv-00057-UNJ Document 28 Filed 11/13/20 Page 1 of 5
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-57V
Filed: October 21, 2020
UNPUBLISHED
Special Master Horner
JAVIER COLON on behalf of S.C., a
minor,
Seizures; Microcephaly;
Developmental Delay;
Petitioner,
Neurogenetic Condition;
v.
IQSEC2 gene variant;
Insufficient Proof; Failure to
SECRETARY OF HEALTH AND
Prosecute
HUMAN SERVICES,
Respondent.
Michael A. London, Douglas & London, P.C., New York, NY, for petitioner.
Alexis B. Babcock, U.S. Department of Justice, Washington, DC, for respondent.
DECISION1
On January 11, 2019, petitioner filed a claim on behalf of his child, S.C., under
the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging
that S.C. suffered an adverse reaction, gastrointestinal issues, digestive issues, reflux,
skin rashes, seizures and spasms as a result of numerous childhood vaccines
administered between January 11, 2016 and January 4, 2017.2 (ECF No. 1.)
1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will
be posted on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.
If the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
2 Specifically, the petition identifies the following vaccinations. On January 11, 2016: diphtheria, tetanus,
and acellular pertussis (“DTaP”); hepatitis B (“Hep B”); Rotavirus; haemophilus influenza B (“Hib”);
inactivated polio (“IPV”); and pneumococcal. On March 29, 2016: DTaP; Hep B, Rotavirus, IPV;
pneumococcal. On June 6, 2016: DTaP; Hep B; Rotavirus; IPV; and pneumococcal. On November 16,
2016: measles mumps and rubella (“MMR”); hepatitis A (“Hep A”); and pneumococcal. On December 2,
2016: influenza (“flu”). On January 4, 2017: flu. (ECF No. 1, pp. 1-2.)

Case 1:19-vv-00057-UNJ Document 28 Filed 11/13/20 Page 2 of 5
I. Procedural History
This case was initially assigned to Special Master Roth. (ECF No. 4.) Along with
the petition, petitioner filed medical records marked as Exhibits 1-4. (ECF No. 1.)
Additional medical records marked as Exhibits 5-8 were later filed on April 19, 2019
along with a Statement of Completion. (ECF Nos. 8-9.) Subsequently, respondent
confirmed that no additional records were outstanding and Special Master Roth ordered
respondent to file his Rule 4(c) Report on June 24, 2019. (ECF No 10; Scheduling
Order (Non-PDF), 6/24/2019.) Respondent did so on August 22, 2019, recommending
against compensation. (ECF No. 11.)
On August 22, 2019, Special Master Roth ordered petitioner to file an expert
report by November 20, 2019; however, the case was reassigned to my docket shortly
thereafter on September 3, 2019. (Scheduling Order (Non PDF), 8/22/2019; ECF No.
13.) I subsequently granted five motions for extensions of time, allowing petitioner a full
eleven months to file an expert report supporting his claim. (ECF Nos. 15-19.)
On May 14, 2020, petitioner filed a status report indicating that “[c]ounsel for
petitioner has spoken with potential experts who have informed them that they will not
be able to submit an expert report on behalf of the petitioner.” (ECF No. 20.) However,
petitioner subsequently filed a further status report on June 15, 2020, indicating that
petitioner nonetheless wished to continue the case and that petitioner’s counsel
intended to move to be relieved as counsel. (ECF No. 21.)
In light of petitioner’s stated intention to continue the case despite being unable
to retain expert support, I held a status conference to explain why an expert report is
necessary to continue the case and to advise that I would be issuing an order to show
cause why the case should not be dismissed. I issued that order to show cause on July
16, 2020, setting a September 16, 2020 deadline for petitioner’s filing of an expert
report. (ECF No. 23.)
On September 16, 2020, petitioner’s counsel filed a status report indicating that
there was a good faith misunderstanding by petitioner that prevented compliance with
my order to show cause and requesting an additional 30 days to comply. I allowed a
final 30-day extension of petitioner’s expert report deadline, but cautioned that
petitioner’s obligations under the order to show cause remained in effect and that failure
to file an expert report by October 19, 2020, would result in dismissal of this case. (ECF
Nos. 24, 25.)
Petitioner filed a status report on October 19, 2020 indicating that he is unable to
submit an expert report by the deadline. (ECF No. 26.)
II. Factual History
S.C. was born on November 9, 2015. (Ex. 3, p. 1.) During gestation, an
ultrasound at six months revealed large ventricles. (Ex. 7, p. 36.) Microcephaly was
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Case 1:19-vv-00057-UNJ Document 28 Filed 11/13/20 Page 3 of 5
present at birth (Ex. 5, p. 12; Ex. 3, p. 32) and doctors initially suspected either a
congenital cytomegalovirus infection or an intrauterine insult during the first trimester
(Ex. 2, p. 83; Ex. 3, p. 34).
S.C. first presented with possible GERD or reflux and feeding problems (x2 days)
at about 9 weeks of age on January 15, 2016. (Ex. 2, p. 85.) Eventually, S.C. had a
gastronomy tube inserted on December 13, 2016. (Ex. 3, p. 289, 303.) S.C. sought
treatment at Pediatric GI/Nutrition PANS clinic for his continued reflux and feeding
difficulty. (Ex. 3, p. 256.) S.C. was diagnosed with cerebral palsy by Dr. Susan L.
Hyman following a pediatric developmental and behavioral consultation. (Ex. 3, p. 799-
801.) Dr. Hyman indicated that S.C.’s “oral motor coordination leading to the need for
gastronomy, the cortical use of vision, constipation, and growth delay are all associated
with cerebral palsy [ ] and the underlying causes of the descriptive diagnosis of cerebral
palsy and global developmental delay.” (Ex. 8, p. 809.)
Rash is first mentioned at S.C.’s March 9, 2016 well child visit, at which time
chronic and worsening seborrhea is documented. (Ex. 2, pp. 77-78.) That condition did
continue to worsen for a time; however, S.C.’s skin condition appears to have been
attributed to nut allergy as it was noted to resolve when his mother stopped or
decreased her nut intake. (Ex. 3, pp. 33, 472.)
At seven months, focal seizures were questioned on June 17, 2016, based on
activity of the left leg. (Ex. 2, p. 60.) Subsequently on July 27, 2016, generalized
seizures were reported, including altered consciousness, drooling, lip smacking, and
unresponsiveness. (Id. at 57.) An EEG was abnormal, showing hypsarrhythmia
consistent with S.C.’s microencephaly. (Ex. 3, p. 91.)
On January 29, 2018, S.C. was evaluated by a neurogeneticist who felt that
S.C.’s medical history, including microcephaly, severe developmental delays, history of
infantile spasms, failure to thrive, gastronomy tube dependence, obstructive sleep
apnea, and brain malformations had a genetic cause. (Ex. 3, p. 836.) Subsequently,
S.C. was confirmed to have a maternally inherited IQSEC2 gene variant. (Id. at 998.)
Although “challenging to interpret,” it was felt that S.C.’s gene variant was “likely
pathogenic” and “a candidate gene for his condition.” (Id.) The doctor specifically
assured S.C.’s parents that a single gene mutation was sufficient to be disease-causing.
(Id. at 1013.)
Although S.C.’s medical history has only been briefly summarized, S.C.’s
complete medical records have been reviewed. It is clear that S.C.’s parents developed
a subjective belief that his condition(s) were vaccine-caused and reported to his
physicians that there was a temporal association between his vaccinations and onset of
his symptoms. However, none of S.C.’s physicians opined that S.C. ever experienced
any vaccine reaction or that any of his symptoms could have been caused by his
vaccinations. Moreover, contrary to the allegation of vaccine-causation, the records are
clear that S.C.’s treating physicians felt that other, more compelling explanations existed
for S.C.’s condition.
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Case 1:19-vv-00057-UNJ Document 28 Filed 11/13/20 Page 4 of 5
S.C.’s parents did succeed in securing a letter from a nurse-practitioner
recommending against future vaccinations. However, this letter is inadequate to
support causation, especially when examining the record as a whole. On July 11, 2018,
a nurse-practitioner provided a letter indicating that:
This letter is written on behalf of [S.C.] at the request of his parents [S.C.]
was recently seen by Dr. David Bearden, one of our neurogenetic providers
at the University of Rochester Medical Center. He has been diagnosed with
a genetic mutation (spelling change), that is maternally inherited (passed
on from Mom), called IQSEC2. It is likely a pathogenic variant that is a
candidate gene for his condition. Based on [S.C.]’s genetic disorder and
parental description of multiple adverse vaccine-related reactions, we are
recommending that he avoid further vaccines in the future. [S.C.] has been
fully vaccinated up to this time and we believe avoiding future vaccines
creates minimal additional risk.
(Ex. 3, pp. 1013-14.)
Importantly, although this letter includes some evidence that one of S.C.’s
physicians apparently acquiesced to his parent’s desire to avoid further vaccinations,
the stated rationale of this letter relies on the minimal risk in avoiding future vaccination
and does not demonstrate that any vaccines caused or contributed to S.C.’s condition.
Moreover, the letter is careful not to ratify the parental report of any vaccine reactions.
As reflected in his notes, vaccine reactions were not a part of Dr. Bearden’s impression
nor was vaccine avoidance among his recommendations. (Id. at 1004.)
III. Discussion
To receive compensation in the Vaccine Program, petitioner must prove either
(1) that S.C. suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury
Table – corresponding to a covered vaccine, or (2) that he suffered an injury that was
actually caused by a covered vaccine. See 42 U.S.C. §§ 13(a)(1)(A) and 11(c)(1). To
satisfy the burden of proving causation in fact, a petitioner must show by preponderant
evidence: “(1) a medical theory causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the vaccination was the reason for
the injury; and (3) a showing of a proximate temporal relationship between vaccination
and injury.” Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir.
2005). No “Table Injury” was alleged in this case. Nor did an examination of the record
uncover any evidence that petitioner suffered a “Table Injury.” Further, upon my review,
S.C.’s medical records do not contain preponderant evidence indicating that S.C.’s
alleged injury was vaccine-caused or in any way vaccine-related.
Under the Vaccine Act, a petitioner may not be given a Program award “based
on the claims of a petitioner alone, unsubstantiated by medical records or by medical
opinion.” 42 U.S.C. § 13(a)(1). In this case, S.C.’s medical records do not indicate any
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Case 1:19-vv-00057-UNJ Document 28 Filed 11/13/20 Page 5 of 5
link between his injuries and his vaccines apart from his parents’ own reported concerns
regarding a temporal association. None of S.C.’s treating physicians opined that his
condition was vaccine-caused or aggravated. Instead, the record shows that S.C.’s
treating physicians believed that S.C.’s condition was the effect of other, more
compelling causes such as congenital gene mutations. Even assuming arguendo that
some or all of S.C.’s symptoms occurred in temporal proximity to his vaccinations, this
is inadequate to demonstrate causation in the absence of a Table Injury. Hibbard v.
Sec’y of Health & Human Servs., 698 F.3d 1355, 1364-65 (Fed. Cir. 2012) (holding the
special master did not err in resolving the case pursuant to Althen Prong Two when
respondent conceded that petitioner met Prong Three).
Because the medical records fail to establish either a Table Injury or any causal
connection between S.C.’s condition and his vaccinations, it was incumbent upon
petitioner to secure the expert opinion of a competent physician. 42 U.S.C. § 13(a)(1).
Thus, because petitioner has failed to secure an expert opinion, he is unable to meet his
burden in this case and the case must be dismissed for insufficient proof. To the extent
petitioner nonetheless expressed a desire to continue this claim (ECF No. 21), I have
already allowed petitioner over one year to secure the expert report needed to support
his claim. Accordingly, petitioner has had a full and fair opportunity to present his claim
and I find in the alternative that his failure to produce an expert report to support this
claim constitutes a failure to prosecute and that dismissal is therefore also appropriate
pursuant to Vaccine Rule 21(b)(1).
IV. Conclusion
Although petitioner has my sympathy for what he, S.C., and his family have
endured, for the reasons discussed above this petition is DISMISSED for insufficient
proof and for failure to prosecute. The clerk of the court is directed to enter judgment in
accordance with this decision.3
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or
jointly, filing a notice renouncing the right to seek review.
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