VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00739
Package ID: USCOURTS-cofc-1_20-vv-00739
Petitioner: C.J.B.
Filed: 2021-09-10
Decided: 2022-03-23
Vaccine: Pentacel and pneumococcal conjugate vaccines
Vaccination date: 2017-06-23
Condition: encephalopathy, speech abnormality, language regression, and/or significant aggravation of an underlying condition, including but not limited to a genetic mutation
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On June 22, 2020, Jeffrey Bello and Oksana Y. Oganesov, parents of C.J.B., a minor, filed a petition for compensation under the National Childhood Vaccine Injury Compensation Program. They alleged that their son developed encephalopathy, speech abnormality, language regression, and/or significant aggravation of an underlying condition as a result of vaccinations received on June 23, 2017, when he was approximately 15 months old. The vaccines administered were Pentacel and pneumococcal conjugate vaccines. The petition was filed by Phyllis Widman of Widman Law Firm LLC. The respondent was the Secretary of Health and Human Services, represented by Benjamin Warder of the U.S. Department of Justice. 

Chief Special Master Brian H. Corcoran reviewed the petition and ordered the petitioners to show cause why the case should not be dismissed, noting that the claim appeared to be one that rarely resulted in a favorable decision and that the preliminary review of the record did not suggest this was one of those rare cases. After reviewing briefs from both parties, the Chief Special Master dismissed the case. He found that the petitioners failed to demonstrate, based on the medical record, that C.J.B. experienced the kind of true encephalopathy required for non-Table claims to find subsequent developmental regression associated with it, and therefore had not established a compensable injury. The Chief Special Master noted that the critical timeframe for establishing a causal relationship was within the first month of vaccination, and the medical records did not suggest a brain injury sufficient to cause developmental delay or regression. He also found that the Chief Special Master did not abuse his discretion by dismissing the case without an evidentiary hearing or expert report, as the petitioners had ample opportunity to present their case and failed to provide sufficient evidence of a brain injury. The court upheld the Chief Special Master's decision, denying the petition for compensation.

Petitioners appealed the decision to the Court of Federal Claims. Chief Judge Elaine D. Kaplan reviewed the case and denied the motion for review. The court found that the Chief Special Master's decision was neither arbitrary, capricious, nor contrary to law. The court agreed that the medical records did not demonstrate that C.J.B. suffered a vaccine-related encephalopathy. The court noted that the medical records did not reflect the rapid decline in C.J.B.'s health and development that his parents described in their affidavit, and that the assertions in the affidavit were not supported by the medical records. The court also found that none of the medical professionals who treated C.J.B. in the months following his vaccinations diagnosed him as suffering from an encephalopathy. The court further found that the Chief Special Master did not abuse his discretion by dismissing the case without an evidentiary hearing or expert report, as the petitioners had been given a full and fair opportunity to present their case in writing and had failed to provide sufficient evidence of a brain injury. The court also denied a motion to submit additional telephone records, finding that the records were not presented to the Special Master and did not cover the critical timeframe for establishing causation. The court upheld the Chief Special Master's decision, denying the petition for compensation.

Theory of causation field:
Petitioners alleged that C.J.B., who was approximately 15 months old, developed encephalopathy, speech abnormality, and language regression as a result of receiving Pentacel and pneumococcal conjugate vaccines on June 23, 2017. The case was filed as a non-Table claim. The Chief Special Master dismissed the case, finding that the medical records did not demonstrate that C.J.B. experienced a compensable injury, specifically a true encephalopathy required for non-Table claims. The court reviewed the Chief Special Master's decision and denied the petitioners' motion for review, finding that the Chief Special Master's determination that the petitioners failed to prove a vaccine-related encephalopathy was supported by the evidence. The court noted that the critical timeframe for establishing a causal relationship was within the first month of vaccination, and the medical records did not suggest a brain injury sufficient to cause developmental delay or regression. The court also found that the Chief Special Master did not abuse his discretion by dismissing the case without an evidentiary hearing or expert report, as the petitioners had ample opportunity to present their case and failed to provide sufficient evidence of a brain injury. The court upheld the Chief Special Master's decision, denying the petition for compensation. No specific medical experts were named in the provided text for either party. The theory of causation was not established by the petitioners.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-00739-0
Date issued/filed: 2021-11-02
Pages: 19
Docket text: rect the Petitioner's first name.) (fm).PUBLIC DECISION (Originally filed: 9/10/2021) regarding 43 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (kav) Service on parties made. (Main Document 48 replaced on 11/2/2021 to cor
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Case 1:20-vv-00739-EDK Document 48 Filed 11/02/21 Page 1 of 19
CORRECTED
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-739V
(to be published)
* * * * * * * * * * * * * * * * * * * * * * * * * Chief Special Master Corcoran
JEFFREY BELLO and OKSANA Y. *
OGANESOV, parents of C.J.B., a minor, *
* Filed: September 10, 2021
Petitioners, *
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Phyllis Widman, Widman Law Firm LLC, Northfield, NJ, for Petitioners.
Benjamin Warder, U.S. Dep’t of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION1
On June 22, 2020, Jeffrey Bello and Oksana Y. Oganesov filed a petition for
compensation under the National Vaccine and Injury Compensation Program (the “Vaccine
Program”).2 (ECF No. 1) (“Petition”). Petitioners allege that their child, C.J.B., developed
encephalopathy, speech abnormality, language regression, and/or significant aggravation of an
underlying condition, including but not limited to a genetic mutation, as a result of a series of
vaccinations he received on June 23, 2017, when he was approximately 15 months old. Pet. at
1.
1 This Decision shall be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of
2002, 44 U.S.C. § 3501 (2012)). This means that the Decision will be available to anyone with access to the
internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion
of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days
within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial
or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the
disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the
whole Decision will be available to the public. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the
Act”]. Individual section references hereafter will be to Section 300aa of the Act (but will omit the statutory prefix).

Case 1:20-vv-00739-EDK Document 48 Filed 11/02/21 Page 2 of 19
After a preliminary review of the Petition and the filed records, I ordered the Petitioners
to Show Cause why the case should not be dismissed. Order, dated February 25, 2021 (ECF No.
29) (“Order”). The Petition appeared to allege a kind of claim that had only rarely resulted in a
favorable entitlement decision in prior cases, and my preliminary review of the record did not
suggest this was one of those rare cases. Both parties have filed briefs in reaction. Petitioner’s
Brief in Support of Claim, dated April 30, 2021 (ECF No. 33) (“Br.”); Respondent’s Brief, dated
June 28, 2021 (ECF No. 39) (“Opp.”); Petitioner’s Reply, dated August 12, 2021 (ECF No. 42)
(“Reply”).
Now, for the reasons set forth below, I hereby dismiss this case. Petitioners cannot
demonstrate based on the medical record that C.J.B. experienced the kind of true
“encephalopathy” required in Program non-Table cases to find subsequent developmental
regression associated with it, and therefore have not established a compensable injury.
I. Medical History
Birth and Early History
C.J.B. was born on March 21, 2016, weighing seven pounds, twelve ounces, and having
APGAR scores of nine at one minute and at five minutes. Ex. 3 at 1, 11-12. He received his
pediatric care from Dr. Edward Rosof at Advocare Marlton Pediatrics (“Advocare”). See
generally Ex. 3. His first well-child visit was unremarkable, and he returned to Advocare on
April 1, 2016, for a weight check and for his first Hepatitis B vaccine dose. Id. at 14-16.
In his first 15 months of life, C.J.B. had regular visits to Dr. Rosof at Advocare – both
for wellness and sick child treatment. See generally Opp. at 4-5 (chart summarizing 21 pediatric
visits or telephone call encounters). During this time, he received a number of vaccines without
incident, and otherwise displayed no significant health problems (beyond occasional instances
of fever or the kind of upper respiratory infections common to infants). C.J.B. otherwise was
healthy and displayed no developmental problems in this time period. See generally Ex. 2
(Petitioners’ joint affidavit).
Vaccinations and Manifestations of Speech Regression
On June 23, 2017, C.J.B. received the Pentacel vaccine (which includes the diphtheria-
tetanus toxoid-acellular pertussis, poliovirus, and haemophilus B conjugate vaccine), along with
the pneumococcal conjugate vaccines, as part of a 15-month well-child checkup at Advocare.
Ex. 1; Ex. 3 at 81-86. He was not taking any medication at this time, and other than a recent ear
infection no health problems or concerns were reported. Ex. 3 at 83-84. C.J.B.’s gross and fine
2

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motor assessment noted that he could throw a ball, crawl up stairs, walk well, and feed himself
using his fingers. Id. And his communication skills were also deemed developmentally correct,
with it noted that he then had “3-6 words and follow[ed] simple commands.” Id.
There is no medical record of any reaction to these vaccinations. However, Petitioners
have alleged that C.J.B. began to lose speech within hours of them, with his vocabulary
decreasing in the days after. Ex. 2 at 1. The Petitioners also allege that they called their
pediatrician for help, but were informed that C.J.B.’s development would be rechecked at his
18-month checkup. Pet. at 1. However, the next chronological medical record (from a June 28,
2017 call to Advocare) contains no reference to dramatic loss of vocabulary or other
developmental issues, and only notes that Ms. Oganesov was inquiring about the appropriateness
of continuing to breastfeed C.J.B., given that she was now pregnant. Ex. 3 at 88.
The next medical record bearing on this claim is from August 2, 2017 – 40 days post-
vaccination – when Ms. Oganesov called Advocare seeking advice about C.J.B.’s sleep issues.
Ex. 3 at 89. She informed treaters that for a few weeks (since the time she had weaned him from
breastfeeding), C.J.B. had been waking at night screaming, and when she tried to console him,
he kicked and bit her, after which he would go back to sleep. Id. Sleep training and sleep hygiene
were reviewed, but this record does not mention any developmental issues. Id. Two weeks later,
on August 16, 2017, Ms. Oganesov called Advocare again after C.J.B. fell down and hurt
himself. Ex. 3 at 89-91. He cried for a short period of time, but was easily consoled, and
otherwise seemed normal after the accident. Id. at 89. Ms. Oganesov was advised to monitor
C.J.B., and to call if there were any changes in his condition. Id. at 90.
The first reference to developmental concerns is found in an August 28, 2017 record of
another call Ms. Oganesov placed to Advocare. Ex. 3 at 90. She now reported that C.J.B. had
“less words than 1 month ago. All other skills [were] unchanged.” Id. If onset were as reported
in this record, C.J.B. would have first experienced loss of vocabulary in late July, or about one
month after the vaccinations at issue (and thus later than what Petitioners have alleged). Ms.
Oganesov was advised that all of C.J.B.’s skills would be rechecked at his 18-month check-up.
Id. Both Petitioners separately called Advocare a second time in early September 2017 about
these same kinds of developmental concerns. Id. at 90-91. Mr. Bello in particular noted that
C.J.B. had received certain vaccines at 15 months, and that he questioned “aluminum toxicity
from the vaccines” based on the assertion that onset of speech regression has occurred after
vaccination (although the record does not specify a precise date). Id. at 91.
Initial Treatment of Alleged Vaccine Reaction
On September 2, 2017, Petitioners opted to bring C.J.B. to the emergency room at Virtua
Health Memorial Hospital in Mount Holly, New Jersey. Ex. 4 at 25. They informed emergency
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treaters that they had concerns C.J.B. had experienced “possible heavy metal poisoning” due to
the June 2017 vaccinations, repeating their prior assertions about his language regression. Id.
Mr. Bello now, however, reported that onset of regression had been about three weeks before,
or right before mid-August rather than in July. Id. Petitioners asked that C.J.B.’s blood be tested
for the suspected metal poisoning. Id. at 27.
Dr. Chung Chiang was the attending physician that afternoon in the emergency
department, and she noted that C.J.B. appeared happy and playful with his parents but did not
speak, except to say “bye bye” to the nursing staff. Ex. 4 at 27. She contacted a toxicologist at
the Children’s Hospital of Philadelphia’s (“CHOP”) department of toxicology, who (after
speaking with Dr. Rosof) told her about C.J.B.’s prior vaccinations – including the fact that the
vaccines he had received on June 23, 2017, contained no metals other than tiny amounts of
aluminum. Id. Dr. Chiang sent two vials of blood and a urine sample to the Mayo Clinic for
testing, and the results (obtained within a few days) were inconclusive. Id. at 40.
A little over two weeks later, Petitioners brought C.J.B. to the CHOP emergency room
on September 19, 2017,3 for “parental concern about aluminum toxicity causing
encephalopathy.” Ex. 8 at 4. The medical records from this treater visit identify onset of speech
regression as “[a]round Labor Day,” and also included reports of C.J.B. biting his mother and
throwing toys, plus anger and temper tantrums. Id.at 3. The treating physician, Dr. Sage Myers,
noted that C.J.B. seemed well on exam, “with “[n]o signs of encephalitis or encephalopathy.”
Id. at 6. She opined that C.J.B.’s “[s]peech regression [was] more likely due to [a] genetic or
developmental disorder. Aluminum toxicity in otherwise normal child extremely unlikely.” Id.
Dr. Myers also observed in this record that in her understanding, the amounts of aluminum in
vaccines were far smaller than what a child was environmentally exposed to otherwise, and that
it was unlikely that a child experiencing an encephalopathy would have a fully normal
neurological exam like C.J.B. Id. at 6.
On October 5, 2017, C.J.B. was taken to see Dr. Mark Magnusson in the Diagnostic
and Complex Care Center at CHOP for evaluation of developmental regression. Ex. 10 at 3.
Consistent with prior histories provided other treaters, Petitioners informed Dr. Magnusson
that C.J.B. had “significant developmental regression with loss of language and [loss] of
behavioral control” after the June vaccinations, as well as their ongoing concern that he had
experienced some kind of toxic reaction to the aluminum in the vaccines. Id. Dr. Magnusson
confirmed the existence of some developmental concerns, and proposed some blood work and
other testing. Id. at 6. Dr. Magnusson nevertheless defined C.J.B. as developmentally normal
otherwise, and proposed the Petitioners take C.J.B. to a developmental pediatrician for further
evaluation. Id. at 9, 35. Petitioners’ Advocare pediatrician made the same kind of
3 Petitioner’s Order to Show Cause response erroneously states that this ER visit occurred on July 19, 2017 – prior to
the August 2017 phone calls to Advocare. Br. at 2.
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recommendation later that month, noting that toxicology testing was not confirming any of
Petitioners’ concerns. Ex. 3 at 108-11.
Petitioners obtained the services of a new pediatrician, Dr. David Bruner, in November
2017, and reported to him their experience of observing C.J.B. lose language in the period after
his 15-month-old vaccinations. Ex. 11 at 9. C.J.B. had not yet, however, undergone a
neurological or speech evaluation. Id. On exam, C.J.B. had a normal gait, “observationally”
normal neurological exam, and good eye contact, and also displayed no behavior outbursts. Id.
at 10-11. Dr. Bruner assessed C.J.B. with “developmental regression in child,” and he noted
differential diagnoses of autism spectrum disorder, genetic disorder, toxic exposure, and
neurological disorder. Id.
Treatment in 2018-2020
Over the next several years, Petitioners continued to seek treatment for C.J.B., along with
an explanation for his speech regression. In February 2018, for example, C.J.B. was taken to
geneticist Dr. Jaya Ganesh to address their concerns that MTHFR gene polymorphisms might
explain C.J.B.’s regressive symptoms. Ex. 7 at 4-13. Dr. Ganesh’s exam revealed that while
“expressive language is definitely behind for age, [C.J.B.] demonstrates age appropriate to
advanced gross and fine motor skills and interactive play.” Id. at 8. MRI and electroencephalogram
testing did not reveal anything concerning, and other testing produced largely normal results. Id.
at 5, 6, 14-17. Dr. Ganesh concluded that “a genetic etiology is not readily apparent.” Id. at 8. The
MRI impressions from the medical record also state that “terminal zones of myelination at the
posterior aspect of the lateral ventricles, [are] within normal for age,” with no evidence of “acute
intracranial abnormality.” Id. at 5.
Petitioners began obtaining glutathione treatment for C.J.B. and reported improvement, but
pediatric treaters like Dr. Bruner identified no abnormal findings otherwise on exam. Ex. 11 at 30-
32 (records from May 24, 2018 visit). C.J.B. continued in 2018 to receive speech therapy, and
additional MRIs were performed, but no records have been filed to date relating to these medical
encounters.
By the spring of 2019 (when C.J.B. was three), Petitioners continued to pursue treatments
aimed at addressing their concerns of metal toxicity associated with vaccination, and their concerns
about his speech loss continued (although it appears from the record that they resisted obtaining
evaluation from schools relating to the extent of the problem). Ex. 11 at 57-59 (records from April
29, 2019 visit with Dr. Bruner). They also disputed prior MRIs that did not confirm the presence
of encephalopathy. Id. at 5. C.J.B. thereafter began at times when he was tired to experience “motor
tics like head shake,” accompanied by pain. Id. at 80.
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In December 2019, Petitioners brought C.J.B. to Nemours Children’s Health System,
where he was seen by Dr. Stephen Falchek, the Chief of Pediatric Neurology, for concerns about
seizures, speech delay, and headaches. Ex. 5 at 4-8. Petitioners now provided a history of pain and
temper tantrums within 24 hours of C.J.B.’s 15-month vaccinations (even though the record as
discussed above is not consistent with this), followed closely by the previously-reported loss of
speech and other symptoms. Id. at 5. After completing a physical exam and reviewing available
studies from CHOP, Dr. Falchek assessed C.J.B. with speech and language regression, and
recommended an EEG and speech therapy consultation. Id. at 7.
Petitioners obtained the recommended speech therapy evaluation in February 2020, and it
showed mild receptive and expressive language delay in combination with mild speech sound
delay, but little evidence of dyspraxia. Ex. 5 at 12-19. Dr. Falchek saw C.J.B. again in April 2020,
for “follow-up of chronic encephalopathy.” Ex. 5 at 9. He specifically noted that C.J.B. had a
“rather complex and confusing medical history.” Id. After review of a 2019 MRI performed on
C.J.B.’s brain, Dr. Falchek deemed the results likely normal. Id. at 10. His impression, however,
was “complex encephalopathy with history of developmental regression in the context of
immunizations and febrile illness.” Id. at 11. This record does not elaborate on the basis for this
conclusion. Petitioners allege that by this time, and despite intense speech therapy, C.J.B.’s speech
remains extremely slurred, making him difficult to understand, although he does manage to
communicate partially.4
II. Procedural History
As noted above, the Petition was filed in the summer of 2020. The matter was released
from “pre-assignment review” later that year, once it was determined that sufficient records existed
to assess the claim in a general matter. ECF No. 20. After its assignment to my docket, I held the
initial status conference in February 2021 referenced previously, at which time I expressed my
concerns about the claim’s viability and asked the parties to brief the issues identified. In particular,
I instructed Petitioners to (a) identify what record evidence already filed supported their claim, and
(b) what prior reasoned Program decisions with consistent facts resulted in entitlement
determinations favorable to the relevant petitioner(s). Order at 2. They have now filed their briefs,
and the matter is ripe for resolution.
4 A few months ago, Petitioners filed more recent medical records. See May 3, 2021 filing (Ex. 12) and May 7, 2021
filing (Ex. 13). The first record is a March 2021 letter from Dr, Bruner stating that C.J.B. is exempt from further
vaccination, and adding in conclusory fashion that C.J.B.’s developmental regression was “probably” due to his
vaccinations. Ex. 12 at 1. The second set of records are treatment documents from Cooper University Hospital (from
the fall of 2020 to the spring of 2021), and they reference C.J.B.’s continued problems, with speech and language,
along with the allegation of a chronic encephalopathy beginning on October 6, 2020. Ex. 13 at 3. There is also a note
that C.J.B.’s mother stated the speech therapy and occupational therapy are progressing. Ex. 13 at 6. I do not find that
any of these more recently-filed records provide any basis for altering my conclusion herein.
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III. Parties’ Arguments
Petitioners’ response to the Order to Show Cause begins with a recitation of the facts
largely consistent with what is set forth above, highlighting in particular the difference between
C.J.B.’s language and speech development pre- versus post-vaccination. Br. at 1-3. They also
emphasize Dr. Falchek’s embrace of encephalopathy “in the context of immunizations” as a
diagnostic explanation for this developmental loss. Id. at 4; Ex. 5 at 9, 11.
To support the continuation of this claim, Petitioners cite two cases that they maintain
underscore that C.J.B. likely experienced a vaccine-induced encephalopathy. Br. at 6; Midland
Trust Co. v. Sec’y of Health & Hum. Servs., No 14-1186V, 2020 WL 5887547 (Fed. Cl. Spec.
Mstr. Sept. 15, 2020); Cook v. Sec’y of Health & Hum. Servs., No. 99-538V, 2004 WL 3049764,
at *17 (Fed. Cl. Spec. Mstr. Dec. 14, 2004). Midland Trust, the Petitioners argue, was a case where
encephalopathy was deemed to explain developmental delay along with seizures, but they do not
provide more than a sentence’s description of the holding therein or why it establishes a basis for
allowing this matter to go on. Br. at 6. Cook, they propose, reached a similar result in the context
of a non-Table claim, finding that the injured child had experienced a chronic encephalopathy. Id.
(This case was incorrectly cited, and is in fact captioned as Noel v. Sec’y of Health & Hum. Servs.,
No. 99-538V, 2004 WL 3049764, at *17 (Fed. Cl. Spec. Mstr. Dec. 14, 2004)). Allowing
Petitioners to obtain an expert, they argue, would permit them the opportunity of establishing how
the records corroborate their favored conclusion herein.
Respondent asks for dismissal of the claim, arguing that the medical history evidence
would not permit a reasonable conclusion, under the preponderance evidentiary test applicable to
non-Table claims, that C.J.B. suffered a vaccine-caused encephalopathy. Opp. at 15. First, he
observes that Petitioner has not made a demonstration consistent with my Order to Show Cause
that the record supports their contentions. In particular, there is little to no contemporaneous
evidence from around the time of the vaccinations to suggest C.J.B. experienced the immediate
and direct symptoms reflecting an encephalopathy. Id. at 16. He highlights in particular the fact
that Petitioners “had a pattern of seeking care and advice for a number of issues” before
vaccination, thus allowing the inference they would also have done so after vaccination had
C.J.B.’s condition truly appeared alarming or in need of medical evaluation. Id. at 16-17.
Respondent also notes that Petitioners’ onset reporting varied in the record – from late July to early
September 2017. Id. at 18-19. And the only treater support for an encephalopathy diagnosis comes
from 2019 or 2020 (largely Dr. Falchek’s evaluation) – and the substantiation for that opinion is
lacking in the record. Id. at 19.
Second, Respondent denies that either of the cases cited in Petitioners’ brief are on point
or otherwise supportive of the continued maintenance of this claim. Opp. at 22-24. Midland Trust,
for example, (which was miscited) is a damages determination resulting from a prior ruling on
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entitlement in a differently captioned case. Id. at 22-23; Morales v. Sec’y of Health & Hum. Servs.,
No. 14-1186V, 2019 WL 4047627 (Fed. Cl. Spec. Mstr. July 30, 2019). But the injured child in
that case developed a post-vaccination fever plus seizures within a day of vaccination, with more
seizures thereafter and subsequent associated developmental delay. Morales, 2019 WL 4047627,
at *1, 7. Thus, Morales/Midland Trust involved strong evidence of an acute reaction wholly absent
from this case. Cook, Respondent argues, is similarly distinguishable, since it too involved proof
of a post-vaccination fever resulting in a series of seizures and associated acute evidence directly
establishing an encephalopathy. Noel, 2004 WL 3049764, at *17. Respondent otherwise observes
that the cases I referenced in my Order to Show Cause (which are discussed again below) provide
more useful guidance supporting the dismissal of this matter. Opp. at 21-22.
Petitioners filed a brief reply, reiterating points in the medical record (such as the treatment
C.J.B. obtained at CHOP in October 2017) that they argued underscored the temporal association
between vaccination and C.J.B.’s language loss. Reply at 1-2. They noted more recent medical
records supporting the chronic encephalopathy diagnosis. Id. at 2. And they underscored that
because they do not assert a Table claim, cases involving the standards relevant to such a claim,
like Wright v. Sec’y of Health & Hum. Servs., No. 12-423V, 2015 WL 6665600 (Fed. Cl. Spec.
Mstr. Sept. 21, 2015) (petitioner met the requirements of an acute encephalopathy as set forth in
the Vaccine Injury Table), are irrelevant. Otherwise, Petitioners maintained that Respondent could
show no alternative cause for C.J.B.’s developmental losses. Reply at 2-3.
IV. Applicable Law
A. Standards for Vaccine Claims
To receive compensation in the Vaccine Program, a petitioner must prove that: (1) they
suffered an injury falling within the Vaccine Injury Table (i.e., a “Table Injury”); or (2) they
suffered an injury actually caused by a vaccine (i.e., a “Non-Table Injury.) See Sections
13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also
Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano, 440
F.3d at 1320. In this case, Petitioners do not assert a Table claim.
For both Table and Non–Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact's
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter., Inc. v. United States, 6 Cl.
Ct. 476, 486 (1984) (explaining that mere conjecture or speculation is insufficient under a
preponderance standard). On one hand, proof of medical certainty is not required. Bunting v. Sec'y
of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). But on the other hand, a petitioner
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must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a
substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v.
Sec'y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of
Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a
Vaccine Program award based solely on his assertions; rather, the petition must be supported by
either medical records or by the opinion of a competent physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non–Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec’y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(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
proximate temporal relationship between vaccination and injury.” Each Althen prong requires a
different showing and is discussed in turn along with the parties’ arguments and my findings.
Under Althen prong one, petitioners must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at
1355–56 (citations omitted). To satisfy this prong, a petitioner's theory must be based on a “sound
and reliable medical or scientific explanation.” Knudsen v. Sec'y of Health & Hum. Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or
scientifically certain.” Id. at 549.
However, the Federal Circuit has repeatedly stated that the first prong requires a
preponderant evidentiary showing. See Boatmon v. Sec'y of Health & Hum. Servs., 941 F.3d 1351,
1360 (Fed. Cir. 2019) (“[w]e have consistently rejected theories that the vaccine only “likely
caused” the injury and reiterated that a “plausible” or “possible” causal theory does not satisfy the
standard”); see also Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir.
2010); Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010). This
is consistent with the petitioner’s ultimate burden to establish his overall entitlement to damages
by preponderant evidence. W.C. v. Sec'y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir.
2013) (citations omitted). If a claimant must overall meet the preponderance standard, it is logical
that they be required also to meet each individual prong with the same degree of evidentiary
showing (even if the type of evidence offered for each is different).
Petitioners may offer a variety of individual items of evidence in support of the first Althen
prong, and are not obligated to resort to medical literature, epidemiological studies, demonstration
of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health & Hum.
Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). No one
“type” of evidence is required. Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
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thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence
standard.” Andreu, 569 F.3d at 1380. Nevertheless, even though “scientific certainty” is not
required to prevail, the individual items of proof offered for the “can cause” prong must each
reflect or arise from “reputable” or “sound and reliable” medical science. Boatmon, 941 F.3d at
1359-60.
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec'y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party's treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec'y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
However, medical records and/or statements of a treating physician's views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec'y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record—including conflicting
opinions among such individuals. Hibbard v. Sec'y of Health & Hum. Servs., 100 Fed. Cl. 742,
749 (2011) (stating it is not arbitrary or capricious for special master to weigh competing treating
physicians' conclusions against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec'y
of Health & Hum. Servs., No. 06–522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29,
2011), mot. for review den'd, 100 Fed. Cl. 344, 356–57 (2011), aff'd without opinion, 475 F. App’x.
765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
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understanding of the disorder's etiology, it is medically acceptable to infer causation.” de Bazan v.
Sec'y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is
a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health &
Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012),
aff'd mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Hum. Servs., No. 11–
355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den'd (Fed. Cl.
Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014).
B. Law Governing Analysis of Fact Evidence
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [ ] relevant medical and scientific evidence contained in the record,” including
“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained
in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,
injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special
master is then required to weigh the evidence presented, including contemporaneous medical
records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.
1993) (determining that it is within the special master's discretion to determine whether to afford
greater weight to contemporaneous medical records than to other evidence, such as oral testimony
surrounding the events in question that was given at a later date, provided that such determination
is evidenced by a rational determination).
As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as
trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95
Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his
contemporaneous medical records, the special master's decision to rely on petitioner's medical
records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked
propositions explains why such records deserve some weight: (i) sick people visit medical
professionals; (ii) sick people are likely to honestly report their health problems to those
professionals; and (iii) medical professionals record what they are told or observe when examining
their patients in as accurate a manner as possible, so that they are aware of enough relevant facts
to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,
2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.
Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to
conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).
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Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are often found to be deserving of greater evidentiary weight than oral testimony—especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
However, the Federal Circuit has also noted that there is no formal “presumption” that
records are automatically deemed accurate, or superior on their face to other forms of evidence.
Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly
situations in which compelling oral or written testimony may be more persuasive than written
records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of
Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense
and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness's credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome contemporaneous medical records, such
testimony must be “consistent, clear, cogent, and compelling.” Sanchez, 2013 WL 1880825, at *3
(citing Blutstein v. Sec'y of Health & Hum. Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed.
Cl. Spec. Mstr. June 30, 1998)). In determining the accuracy and completeness of medical records,
the Court of Federal Claims has listed four possible explanations for inconsistencies between
contemporaneously created medical records and later testimony: (1) a person's failure to recount
to the medical professional everything that happened during the relevant time period; (2) the
medical professional's failure to document everything reported to her or him; (3) a person's faulty
recollection of the events when presenting testimony; or (4) a person's purposeful recounting of
symptoms that did not exist. La Londe v. Sec'y of Health & Hum. Servs., 110 Fed. Cl. 184, 203–
04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to
afford greater weight to contemporaneous medical records or other evidence, such as testimony at
hearing, there must be evidence that this decision was the result of a rational determination. Burns,
3 F.3d at 417.
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C. Disposition of Case Without Hearing
I am resolving this claim on the papers, rather than by holding a hearing. The Vaccine Act
and Rules not only contemplate but encourage special masters to decide petitions on the papers
where (in the exercise of their discretion) they conclude that doing so will properly and fairly
resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu
of hearing has been affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d
1362, 1366 (Fed. Cir. 2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V,
2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where
special masters decided case on the papers in lieu of hearing and that decision was upheld). I am
simply not required to hold a hearing in every matter, no matter the preferences of the parties.
Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special
master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy
v. Sec’y of Health & Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Ct. Cl. Spec. Mstr. Apr.
19, 1991).
ANALYSIS
I. Encephalopathy, Regression, and Prior Relevant Decisions5
Although this is a non-Table case, the Table definition of “encephalopathy” provides some
insights into the factors deemed sufficient by Respondent to establish a claim in which causation
is presumed – and thus what would be particularly strong evidence of a vaccine injury in this
context. See 42 C.F.R. § 100.3(a)(II)(B) (2018). Petitioners herein are not obligated to meet these
requirements, but some brief review of them helps illuminate the kinds of symptoms that would
be associated with an encephalopathy resulting in developmental deficits.
Table claimants seeking to prove a vaccine-caused encephalopathy must establish both that
the injured party experienced an “acute” encephalopathy—typically evidenced by a decreased
change in consciousness (as that term is defined in the Qualifications and Aids to Interpretation,
42 C.F.R. § 100.3(c)(2) (2018)) of sufficient severity to warrant hospitalization—and that the
encephalopathy subsequently became “chronic” (that is, it lasted for at least six months).
Thompson v. Sec’y of Health & Hum. Servs., No. 15-1498V, 2017 WL 2926614, at *7–8 (Fed. Cl.
5 Decisions from different cases do not control the outcome herein, with only Federal Circuit decisions setting legal
standards to which new claims must adhere. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1358-59 (Fed.
Cir. 2019); Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). Nevertheless, special masters
reasonably draw upon their experience in resolving Vaccine Act claims. Doe v. Sec’y of Health & Hum. Servs., 76
Fed. Cl. 328, 338-39 (2007) (“[o]ne reason that proceedings are more expeditious in the hands of special masters is
that the special masters have the expertise and experience to know the type of information that is most probative of a
claim”) (emphasis added). They would thus be remiss in ignoring prior cases presenting similar theories or factual
circumstances, along with the reasoning employed in reaching such decisions.
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Spec. Mstr. May 16, 2017). The acute encephalopathy must manifest within three days/seventy-
two hours, and if alleged to have been experienced by a child less than eighteen months old, must
be “indicated by a significantly decreased level of consciousness that lasts at least 24 hours.” 42
C.F.R. §100.3 (2017). My Order to Show Cause cited the Wright case as an example of the rare
circumstances in which such elements have been met (and even despite the fact that it involved a
child diagnosed with autism – a kind of claim that has never succeeded in the Program). Wright,
2015 WL 6665600, at *30-31.
A causation-in-fact claim alleging encephalopathy, by contrast, is not subject to the Table’s
stringent defined requirements. But where encephalopathy as the injury is alleged, it must be
supported by preponderant proof, and that evidence must establish more than simply a subsequent
neurologically-derived symptom. Specific evidence that would suggest an individual had
experienced an encephalopathy sufficient to meet the preponderant test in a non-Table context
includes proof of crying, insomnia, fever, moodiness, and irritability. Noel, 2004 WL 3049764, at
*17.
I have decided many non-Table cases in which a claimant alleged a child experienced
developmental regression following vaccination, in the absence of evidence of a seizure disorder
– and in all such matters have denied entitlement. See, e.g., A.S. v. Sec'y of Health & Hum. Servs.,
No. 16-551V, 2019 WL 5098964 (Fed. Cl. Spec. Mstr. Aug. 27, 2019) (no evidence of post-
vaccination encephalopathic reaction to vaccine that could later have produced expressive
language disorder or autism); Kreizenbeck v. Sec'y of Health & Hum. Servs., No. 08-209V, 2018
WL 3679843 (Fed. Cl. Spec. Mstr. June 22, 2018), mot. for review den’d, 141 Fed. Cl. 138 (2018),
aff'd, 945 F.3d 1362 (Fed. Cir. 2020) (affirming dismissal where petitioners could not demonstrate
vaccine-caused mitochondrial disorder resulting in developmental harm); Austin v. Sec’y of Health
& Hum. Servs., No. 05-579V, 2018 WL 3238608 (Fed. Cl. Spec. Mstr. May 15, 2018), mot. for
review den’d, 141 Fed. Cl. 268 (2018), aff’d, 818 F. App'x 1005 (Fed. Cir. 2020) (affirming denial
of entitlement for a claim in which the medical record did not support the alleged injury of
encephalopathy, vaccine induced or otherwise, resulting in developmental regression).6
Such petitioners have frequently pointed to the temporal relationship between evidence of
developmental decline and vaccination, and often over-relied on witness testimony a child
experienced a concerning reaction right before showing regression, but without being able to
corroborate their contentions in any medical records. In addition, and more importantly, in such
cases petitioners could point to no medical evidence that the child had ever been suspected by
medical treaters of suffering any kind of neurologic brain injury. See, e.g., Austin, 2018 WL
3238608, at * 277. The claimants simply maintained that the evidence of post-vaccination
6 Some of these cases also involved the direct allegation that a child’s autism was vaccine-caused -- although, when
confronted with the tenuous legal merit of such a claim, the relevant petitioners often have backed away from or
renounced the allegation. See, e.g., Kreizenbeck, 2018 WL 3679843, at *26-27. Here, by contrast, the record does not
establish that C.J.B. received that diagnosis, nor do the Petitioners so allege.
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developmental regression meant the child had likely experienced a vaccine-related injury – despite
an absence of evidence establishing that injury.
II. Petitioners Cannot Show C.J.B. Experienced an Encephalopathy
Identifying whether the alleged injury actually occurred is critical to this claim’s resolution.
Broekelschen, 618 F.3d at 1346. In this case, Petitioners argue C.J.B. experienced a vaccine-
induced encephalopathy that later caused his language regression, plus a number of other follow-
on symptoms (although the “through-line” symptom primarily at issue herein is speech loss). The
vaccines C.J.B. received could only “cause” language loss if they first harmed the brain – so a
finding of this having occurred is a prerequisite to a favorable entitlement finding.
But insufficient preponderant evidence exists in this case that would support a
determination that C.J.B. suffered an encephalopathy in any reasonable post-vaccination
timeframe. The medical records filed in this case do not establish anything close to suggesting a
brain injury sufficient to lead to any form of developmental delay or regression, with no instances
in which C.J.B. received emergency care from June to the fall of 2017 not prompted by Petitioners’
personal concerns about vaccine metal toxicity or language loss. Certainly, this record establishes
that Petitioners regularly demonstrated their concern for C.J.B.’s health by seeking out treatment
for him, both before and after the vaccinations in question, so it is reasonable to conclude they
might have done so had he displayed any concerning symptoms directly suggestive of a brain
injury. Opp. at 4-5 (setting forth numerous instances in which Petitioners obtained treatment of
C.J.B.). There is also no evidence he ever had any change in consciousness in this period that
might have reflected the existence of an encephalopathic event, and no treaters who saw him in
the six months after vaccination proposed otherwise. And unlike some of the cases Petitioners
reference, such as Morales or Noel, there is no evidence herein at all that C.J.B. has ever had
seizures or any kind of seizure disorder – and thus determinations that seizure activity harmed the
brain sufficient to cause developmental regression or plateauing have no bearing at all on this case.
In addition, treater evidence supporting the claimed encephalopathy is fairly weak, and
certainly not preponderant. The best Petitioners can offer is Dr. Falchek’s diagnosis, but it was
arrived at more than two years after vaccination, and seems also to rely on Petitioners’ reported
history rather than the record filed in this case, which are inconsistent with what he was told.
Otherwise, as Respondent has noted, the substantiation for this diagnosis is weak. And the
evidence filed in this case contemporaneous with vaccination would not corroborate an after-the-
fact assertion by a treater that, despite the lack of contemporaneous evidence that the vaccines
harmed C.J.B., the records were in error. Prior MRIs that might bulwark the encephalopathy
contention were not consistent with that conclusion – Dr. Falchek even acknowledged “normal
myelination patterns per reports.” Ex. 5 at 10. At bottom, the critical timeframe for looking for
evidence of encephalopathy in this case is within the first month of vaccination – and that record
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does not preponderantly support the conclusion that an encephalopathy occurred.
Although it is not clear whether Petitioners ever obtained proper medical confirmation of
their claim that C.J.B. began manifesting language loss in July or August 2017, their general claim
of it having happened is not rebutted by the record. But this makes no difference for purposes of
my determination, since these symptoms cannot persuasively be pointed to as proof of
“encephalopathy”—they are at most sequelae of an alleged encephalopathy, and therefore it is
circular reasoning to propose that they prove C.J.B. experienced an encephalopathy in the first
place merely by pointing to the fact of language loss. See R.V. v. Sec’y of Health & Hum. Servs.,
No. 08-504V, 2016 WL 3882519, at *34, n.80 (Fed. Cl. Spec. Mstr. Feb. 19, 2016), mot. for review
denied, 127 Fed. Cl. 136 (2016) (discussing the limited value of evidence of developmental loss
in confirming or substantiating a mitochondrial disorder). The language loss cannot be attributed
to vaccination without preponderant proof of a vaccine-caused brain injury.
My decision herein admittedly gives more weight to medical records - which show no
immediate efforts from late June to even the fall of 2017 to treat C.J.B. for suspicious symptoms
that would directly corroborate their allegations of a brain injury – than to Petitioners’ witness
statement claims that they observed C.J.B. act differently after vaccination in this timeframe
(beyond the documented instances in which they reported language loss). I acknowledge that (as
the Federal Circuit has recently stressed in Kirby) petitioners can “prove” a variety of fact matters
pertaining to symptoms or onset even where records are silent on the contention at issue. Records
do not automatically trump witness testimony.
Nevertheless, records still have evidentiary value, and must be weighed against witness
statements. And it remains the case that claimants cannot prevail solely on the basis of their own
claims. Section 13(a)(1). Rather (and especially when a record alone does not memorialize a
contention) petitioners need to offer a mix of proof, and show how records corroborate witness
statements and vice versa, based upon the totality of proof. Here, the records do corroborate
Petitioners’ claims that C.J.B. began to experience post-vaccination language regression – but they
do not reflect or confirm the contention that this was due to encephalopathy. Since the regression
is a symptom of a vaccine-induced brain injury, the inability to prove that injury is fatal to the
claim.7
7 Because Petitioners cannot show that C.J.B. actually experienced the kind of encephalopathy that might arguably
lead to developmental harm, the vaccines he received could not be found causal, and therefore there is no need to
conduct a full Althen analysis. Dillon v. Sec’y of Health & Hum. Servs., 114 Fed. Cl. 236, 244 (2014) (citing Lombardi
v. Sec’y of Health & Hum. Servs., 656 F.3d 1343, 1353 (2011)).
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III. This Case Was Reasonably Resolved Without a Hearing
I am opting to dismiss this case on the existing record, and without holding a hearing,
early on in its “life.” Determining how best to resolve a case is a matter that lies generally within
my discretion, but I shall explain my reasoning.
Prior decisions have recognized that a special master’s discretion in deciding whether to
conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to “afford[] each
party a full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400–01 (citing Rule
3(b)). But that rule also includes the obligation of creation of a record “sufficient to allow review
of the special master’s decision.” Id. Thus, the fact that a claim is legitimately disputed, such that
the special master must exercise his intellectual faculties in order to decide a matter, is not itself
grounds for a trial (for if it were, trials would be required in every disputed case). Special masters
are expressly empowered to resolve fact disputes without a hearing—although they should only
so act if a party has been given the proper “full and fair” chance to prove their claim.
My review of the record plus Petitioners’ arguments have convinced me that they cannot
preponderantly establish that C.J.B. suffered a vaccine-induced encephalopathy responsible for his
developmental problems. It is admittedly the case that in rare circumstances, claimants have
successfully demonstrated that a vaccine could precipitate an encephalopathy in an infant, leading
to similar kinds of injuries as alleged herein. But the facts in such cases underscore the importance
of evidence of immediate and acute encephalopathy precipitated by a close-in-time vaccination.
See, e.g., Wright, 2015 WL 6665600, at *10 (record evidence established that child had convulsed
and vomited during car ride home after receiving vaccinations (possibly evincing a brief seizure),
then became listless, unresponsive, and “basically catatonic” by the following day); Bast v. Sec’y
of Health & Hum. Servs., No. 01-565V, 2012 WL 6858040, at *35–36 (Fed. Cl. Spec. Mstr. Dec.
20, 2012) (discussing case report about Hannah Poling, a successful Vaccine Program claimant
who alleged a Table encephalopathy claim for her autism-type symptoms; noting that Hannah
developed a high fever, inconsolable crying, irritability, and lethargy, and refusal to walk within
forty-eight hours after vaccination), mot. for review den’d, 117 Fed. Cl. 104, 107, aff’d, 579 F.
App’x 1001 (Fed. Cir. 2014). And the cases Petitioners cite in response to this Order to Show
Cause, like Noel or Morales, show mainly that injuries well understood to lead later to
developmental issues, like seizure disorders (which do damage to the brain every time a seizure is
experienced), have been proven to be vaccine-associated – but no such kind of seizure disorder
occurred under the undisputed facts of this case.
Otherwise, this kind of case is far more often than not unsuccessful - because claimants
usually cannot establish that the infant or child vaccinee experienced any acute injury in the
immediate days after vaccination, and instead rely mainly on parent recollection of post-
vaccination behavioral changes that are uncorroborated by contemporaneous medical records.
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Austin, 2018 WL 3238608 at *4-6; A.S., 2019 WL 5098964 at *3-4. The relevant records filed in
this case do not support the conclusion that the onset of C.J.B.’s condition occurred within a
reasonable timeframe following receipt of the June 23, 2017 vaccines, and it does not appear that
C.J.B. has ever received an encephalopathy diagnosis from a contemporaneous treater.
I also note that the record reveals some concern by Petitioners that metal toxicity, due to
aluminum included as an adjuvant8 in some of the vaccines C.J.B. received, could have prompted
injury. But this kind of theory has also uniformly been rejected in the Program as an explanation
for developmental issues due to a brain injury. A.S., 2019 WL 5098964, at *8; Morris v. Sec’y of
Health & Hum. Servs.¸No. 12-415V, 2016 WL 3022141, at *12 (Fed. Cl. Spec. Mstr. Apr. 1, 2016)
(discussing lack of reliability of theory of autoimmune/inflammatory syndrome induced by
adjuvants (“ASIA”), which involves purported propensity of aluminum adjuvant to cause
autoimmune diseases).
Because of the foregoing, it would be an unnecessary expenditure of judicial resources to
continue the case (no matter how admittedly heartfelt Petitioners’ desire to maintain the case might
be). It is for this reason that I issued a show-cause order so early in the case’s life. The inquisitorial
function of special masters in the Vaccine Program obligates them to steer cases in the most
sensible and legally-proper direction, based on the facts presented as well as the special master’s
experience with comparable claims. Just as cases that appear meritorious should be pushed in the
direction of settlement or a swift resolution, so too should cases that plainly are lacking in
evidentiary basis be pushed in the direction of termination. Because my preliminary review of the
filings did not suggest to me this case should continue to exist, I asked Petitioner to establish
whether, and how, I might be wrong. And despite due opportunity, Petitioner has not succeeded in
doing so.
The fact that Petitioners have not yet offered an expert opinion does not alter my
conclusions, or establish a reason for allowing the matter to persist. Petitioners could no doubt find
an expert willing to advocate for them – but such efforts would run head-on into an absence of
persuasive, contemporary medical support for the conclusion that C.J.B. likely experienced any
kind of vaccine-induced injury sufficient to cause developmental problems. Thus, allowing that
process to occur (which would also entail Respondent likely seeking to offer a rebuttal expert of
8 There are many cases that have tried to prove claims of toxicity from the aluminum included in vaccines, theorizing
that it produces toxicity or harms due to ASIA. See generally Rogero v. Sec'y of Health & Hum. Servs., No. 11-770V,
2017 WL 4277580 (Fed. Cl. Spec. Mstr. Sept. 1, 2017), aff’d, 748 F. App’x 996 (Fed. Cir. 2018); Bushenell v. Sec’y
of Health & Hum. Servs., No. 02-1648V, 2015 WL 4099824 (Fed. Cl. Spec. Mstr. June 12, 2015). Specifically, in
Bushnell the Special Master quoted the expert in the case stating, “[t]here are no cases published in the peer-reviewed
medical literature that report aluminum toxicity, including neurotoxicity, due [to] the doses of aluminum found in
vaccines.” (Ex. G, p. 6.) 2015 WL 4099824, at *14.
18

Case 1:20-vv-00739-EDK Document 48 Filed 11/02/21 Page 19 of 19
his own) would waste time and Program resources.9
Finally, my determination does not turn on the supposition or suspicion that this case
actually seeks to litigate the oft-rejected claim that C.J.B. experienced vaccine-caused autism.
Anderson v. Sec’y of Health & Hum. Servs., 131 Fed. Cl. 735 (2017), aff’d, 717 F. App'x 1009
(Fed. Cir. 2018). Petitioners have gone out of their way to note that C.J.B. was never diagnosed
with autism, and I concur the record does not directly say otherwise.10 Rather, my determination
to dismiss flows directly from the fact that the medical record does not establish encephalopathy
as an injury that could in turn have caused developmental problems. Many petitioners have hoped
to show a child’s developmental issues were vaccine-caused, but they cannot succeed in doing so
solely by relying on the evidence of the developmental problem. Where the record does not allow
the conclusion that a true brain injury occurred in the first place, developmental symptoms that
manifest post-vaccination cannot be linked to the vaccine – and there is no reason to allow the
matter to proceed.
CONCLUSION
For the aforementioned reasons, this claim is dismissed. In the absence of a timely-filed
motion for review (see Appendix B to the Rules of the Court), the Clerk shall enter judgment in
accord with this Decision.11
IT IS SO ORDERED.
s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
9 In addition, any expert opinion that C.J.B. suffered metal toxicity, due to the miniscule amounts of aluminum
contained in the vaccines he received (as an adjuvant, to encourage immunogenicity), would utterly fail the
preponderant test. The Program has uniformly rejected causation theories relying on this theoretical contention as
scientifically unreliable. Rogero, 2017 WL 4277580, at *64-65.
10 Autism is, however, mentioned in some diagnostic differentials. See, e.g., Ex. 7 at 4, 9, 13; Ex. 8 at 5, 25. And it is
not clear whether Petitioners ever have ever attempted to rule it out or have C.J.B. screened formally for it.
11 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.
19

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_20-vv-00739-1
Date issued/filed: 2022-03-23
Pages: 20
Docket text: PUBLIC OPINION on Petitioners' Motion for Review and Motion for Leave to File telephone records. (Originally issued 3/3/2022). Signed by Chief Judge Elaine D. Kaplan. (tjd) Service on parties made.
--------------------------------------------------------------------------------
Case 1:20-vv-00739-EDK Document 60 Filed 03/23/22 Page 1 of 20
In the United States Court of Federal Claims
(Filed Under Seal: March 3, 2022 | Reissued for Publication: March 23, 2022)*
)
JEFFREY BELLO and OKSANA Y. )
OGANESOV, Parents of C.J.B., A Minor, )
)
Petitioners, ) No. 20-739V
)
v. )
)
SECRETARY OF HEALTH AND HUMAN )
SERVICES, )
)
Respondent. )
)
)
Phyllis Widman, Widman Law Firm LLC, Northfield, NJ, for Petitioners.
Benjamin Warder, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice,
Washington, DC, with whom were Alexis B. Babcock, Assistant Director, Heather L. Pearlman,
Deputy Director, C. Salvatore D’Alessio, Acting Director, and Brian M. Boynton, Acting
Assistant Attorney General, for Respondent.
OPINION AND ORDER
KAPLAN, Chief Judge.
This case arises under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.
§§ 300aa-1 to -34 (“Vaccine Act” or “the Act”). It is currently before the Court on a motion for
review filed by Petitioners Jeffrey Bello and Oksana Oganesov on behalf of their son, C.J.B.
Petitioners challenge Chief Special Master Brian Corcoran’s Decision on Entitlement dismissing
their case without holding an evidentiary hearing based on his determination that the medical
records did not demonstrate that C.J.B. had experienced a compensable injury.
For the reasons set forth below, the Court concludes that the Chief Special Master’s
decision is neither arbitrary, capricious, nor contrary to law. Petitioners’ motion for review must
therefore be DENIED.
* Pursuant to Vaccine Rule 18(b), this opinion was initially filed on March 3, 2022, and the
parties were afforded fourteen days to propose redactions. The parties did not propose any
redactions and, accordingly, this Opinion is reissued in its original form for publication.

Case 1:20-vv-00739-EDK Document 60 Filed 03/23/22 Page 2 of 20
BACKGROUND
I. C.J.B.’s Birth and Health History
C.J.B. was born on March 21, 2016, weighing seven pounds and twelve ounces. Pet’rs’
Ex. 3, at 1, 11–12, ECF No. 7-3. At his first well-child visit on March 25, 2016, C.J.B.’s physical
exam was normal. Id. at 11–14. On April 1, 2016, C.J.B. returned for a weight check and to
receive his first Hepatitis B vaccination. Id. at 14–16.
C.J.B. received well-child checkups at the age of one, two, four, six, nine, and twelve
months. Pet’rs’ Ex. 3, at 23–25, 31–35, 37–43, 46–52, 59–62, 64–69. Medical records from these
visits reflect that C.J.B. was a healthy baby whose physical exams were normal. See id. They
also reflect that he received a series of vaccinations during the visits, with no negative reactions
reported other than crankiness or fussiness the day the vaccination was administered. Id. at 36,
71–72.1
Beginning in the first month of C.J.B.’s life, Petitioners sought the advice of his
pediatrician on a regular basis. See id. at 17–18, 20–21 (April 4, 2016 call seeking advice about
upset stomach; April 9, 2016 call to report coughing, wheezing, and congestion; April 10, 2016
call and visit about congestion). Over the next fourteen months, C.J.B.’s mother called his
pediatrician, made medical appointments for him, or took him to the emergency room at least
fourteen more times. During these calls and visits she sought advice and care for a wide range of
concerns, including fussiness, fever, feeding issues, irritability, congestion, rashes, and falls and
head injuries. See id. at 26–30, 36, 43–46, 55–56, 63–64, 71–80; Pet’rs’ Ex. 4, at 47, ECF No.
7-4.
II. C.J.B.’s Health and Development Between His June 23, 2017 Vaccinations and the
August 28, 2017 Call His Mother Made to the Pediatrician
On June 23, 2017, during his fifteen-month well-child visit, C.J.B. received the Pentacel
and pneumococcal conjugate vaccines. Pet’rs’ Ex. 3, at 81–87. The affidavit Petitioners
submitted to the Chief Special Master states that C.J.B.’s health and development “rapidly
declined” after he received these vaccinations. Pet’rs’ Ex. 2, ¶ 4, ECF No. 7-2. They describe
C.J.B. as “crying constantly after coming home from the doctor’s office,” and further assert that
he was “having ‘fits’ every [three to five] minutes.” Id. ¶ 5. Petitioners also stated that C.J.B.
1 During this period, C.J.B. received hepatitis B vaccines; Pentacel (which includes the
diphtheria-tetanus toxoid-acellular pertussis, poliovirus, and haemophilus B conjugate vaccines);
pneumococcal conjugate vaccines; and rotavirus vaccines at two, four, and sixth months of age;
as well as measles, mumps, and rubella and varicella vaccines. Pet’rs’ Ex. 3, at 23–25, 31–35,
37–43, 46–52, 59–62, 64–69. The record reflects that on June 3, 2016, and April 19, 2017,
C.J.B.’s mother called his pediatrician to inquire if crankiness was a normal reaction to the
vaccinations he had received that day and two weeks prior, respectively. Id. at 36 (June 3, 2016
call); id. at 71–72 (April 19, 2017 call reporting that C.J.B. was cranky and had a rash). The
record reflects that C.J.B.’s providers reassured his mother that fussiness on the day an infant
receives a vaccine is normal. Id. at 36.
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“very rapidly began to lose his ability to say many of the words that he had been saying daily for
weeks,” ultimately “los[ing] his entire ability to speak” within three weeks of vaccination. Id.
¶ 6; see also id. ¶ 7 (stating that C.J.B.’s “condition worsened daily until . . . September 2017”).
They also allege that they “called the pediatrician for help, but did not receive any guidance or an
appointment.” Br. in Support of Pet’r’s Claim and in Resp. to Order to Show Cause (“Pet’rs’
Resp. to Show Cause Order”) at 2, ECF No. 33.
The medical records before the Chief Special Master do not reflect the rapid decline in
C.J.B.’s health and development that his parents described in their affidavit. Among other things,
there is no record of any call to the pediatrician the day of the vaccination when his parents
stated C.J.B. was “crying constantly” and having “fits” every few minutes. Nor do the records
reflect that they sought medical assistance in the ensuing three weeks to address what they state
in their affidavit was his complete loss of the ability to speak.
The first call to the pediatrician that is reflected in the medical records occurred on June
28, 2017, five days after vaccination. Pet’rs’ Ex. 3, at 88. During the call, C.J.B.’s mother asked
for advice about weaning him from breastfeeding. Id. She reported that she had stopped
breastfeeding him during the day and wanted to stop doing so at night as well. Id. The record of
that call includes no mention of any unrelated health or behavioral issues. See id.
Some five weeks later, on August 2, 2017, C.J.B.’s mother called the pediatrician again,
this time for advice on C.J.B.’s sleep issues. Id. at 88–89. She reported that, in the past “few
weeks,” since she had weaned him from breastfeeding, he had been “wak[ing] up at night
screaming” and kicking and biting her. Id. at 89. The pediatrician provided C.J.B.’s mother with
advice on “sleep training/sleep hygiene” and noted that this behavior corresponded with C.J.B.
being weaned from nighttime breastfeeding. Id.
C.J.B.’s mother called the pediatrician two weeks later, on August 16, 2017, after he fell
down some steps. Id. at 89–90. During the call, she reported that he had a “large bump” on his
head, but that his behavior was otherwise normal and that he had been easily consoled after his
fall. Id. at 89. She was told to monitor C.J.B. for signs of a concussion, and to call again if his
symptoms changed. Id. at 90.
III. C.J.B.’s Parents Pursue Medical Treatment for His Loss of Speech and Related
Symptoms (August 28, 2017–December 29, 2018)
The first mention of any concern about C.J.B.’s language or development skills appears
in a medical record dated August 28, 2017. Pet’rs’ Ex. 3, at 90. On that day, C.J.B.’s mother
called the pediatrician and reported that he “ha[d] less words than [one] month ago” (i.e., the end
of July, which was approximately four to five weeks post vaccination). Id. She was told that
C.J.B.’s skills, including his speech, would be checked at his eighteen-month well-child visit,
presumably in September. Id.
Four days later, on Friday, September 1, 2017, both of C.J.B.’s parents—first his father
and, a few hours later, his mother—placed more urgent calls to their son’s pediatrician. Id. at 90–
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91. The notes of the pediatrician’s office reflect that Petitioners had called several times and
wanted to “discuss [C.J.B.’s] speech” “as soon as possible.” Id. at 91.
Having not received a call back from the pediatrician on Friday, Petitioners took their son
to the emergency room at the Virtua Memorial Hospital the next day (Saturday, September 2,
2017). Pet’rs’ Ex. 4, at 25. They told the emergency room doctor that C.J.B. had begun to
experience language regression three weeks earlier (i.e., mid-August, approximately seven weeks
post vaccination). Id.; see also Pet’rs’ Ex. 3, at 92 (documenting toxicology department doctor’s
call to C.J.B.’s pediatrician seeking his vaccination history). They expressed concern that C.J.B.
may have experienced “heavy metal poisoning” from his June 23, 2017 vaccinations, Pet’rs’ Ex.
4, at 25, and requested “aluminum and lead testing,” id. at 27.
During this visit, emergency room providers noted that C.J.B. was “awake, alert, and
comfortable during evaluation.” Id. at 25. After obtaining C.J.B.’s medical records from his
pediatrician, Pet’rs’ Ex. 3, at 92, the doctor noted that he had not had a reaction to the vaccines
he had received on April 3, 2017, and that the vaccines he had received on June 23, 2017, “did
not contain mercury or other metals,” Pet’rs’ Ex. 4, at 27. Nevertheless, they conducted urine and
blood aluminum testing. Id. (noting that C.J.B.’s parents told the doctor his “lead level [had
been] obtained previously,” and that the results were “normal”).
The next day, on Sunday, September 3, 2017, C.J.B.’s pediatrician returned the calls
Petitioners had placed to him on September 1. Pet’rs’ Ex. 3, at 91. C.J.B.’s father expressed his
concern about “aluminum toxicity from the [June] vaccines,” in light of the fact that his son’s
vocabulary of twenty-plus words had disappeared. Id. He requested “immediate blood testing,”
to which the pediatrician responded that he “would like to get a neurology and developmental
evaluation . . . first.” Id. The pediatrician explained that he would call back in two days (i.e., the
Tuesday after the Labor Day holiday). Id. C.J.B.’s pediatrician then made an appointment for
him to see developmental pediatrician Dr. Theresa McSween on September 19, 2017. Id. at 92–
93.
In the meantime, C.J.B.’s mother called the pediatrician again on September 8, 2017,
concerned that her son’s symptoms were worsening. Id. at 93. The following day, he called to
assure her that he would “check on [the] heavy metal screening” and confirm their appointment
with the developmental pediatrician. Id. at 93, 98.
On September 11, 2017, C.J.B.’s mother brought him to the Virtua Memorial Emergency
Room following a fall. Id. at 98, 135–36; see also Pet’rs’ Ex. 4, at 6–9. He was evaluated and,
because he was not exhibiting any symptoms of a concussion, discharged. Pet’rs’ Ex. 4, at 9.
On September 19, 2017—the day C.J.B. was to be seen by the developmental
pediatrician—Petitioners took him instead to the Emergency Department at the Children’s
Hospital of Philadelphia. See Pet’rs’ Ex. 8, at 3–7, ECF No. 7-8; id. at 6 (explaining that C.J.B.’s
“pediatrician was able to get [an] appointment scheduled for 1pm today with [a] neurologist,”
but that the “family did not go to this appointment as [they] did not believe that child needed
developmental pediatrician”). The emergency department intake notes state that Petitioners had
“started noticing decreased speech [and] mood swing[s]” “[a]round [L]abor [D]ay” (i.e.,
4

Case 1:20-vv-00739-EDK Document 60 Filed 03/23/22 Page 5 of 20
September 4, 2017), and were concerned that their son had experienced “aluminum toxicity”
following his vaccination. Id. at 3.
Petitioners told Dr. Sage Myers, who treated C.J.B. during this visit, that his language
skills had been regressing “over the last few weeks,” which his father “believe[d] [was] due to
toxic encephalopathy from aluminum.” Id. at 4 (noting that C.J.B.’s “[f]ather reports that he has
done extensive research and read many periodicals on this topic and is certain of this diagnosis”).
Dr. Myers, however, saw “[n]o signs of encephalitis or encephalopathy” following a “[n]ormal
. . . full neuro[logical] exam.” Id. at 6–7. She opined that C.J.B.’s “[s]peech regression [was]
more likely due to [a] genetic or developmental disorder,” given that “[a]luminum toxicity in
[an] otherwise normal child [would be] extremely unlikely.” Id. at 6. Dr. Myers encouraged
Petitioners “to continue to [follow up] with developmental pediatrics to help aid in diagnosis.”
Id. at 7.
On October 5, 2017, C.J.B. returned to the Children’s Hospital of Philadelphia for a
follow-up appointment with Dr. Mark Magnusson. Pet’rs’ Ex. 10, at 9, ECF No. 14-2. Dr.
Magnusson noted that C.J.B.’s parents were “concerned and convinced that he has aluminum
toxicity,” id. at 3, and “aluminum encephalopathy,” and that they “reported loss of language and
onset of temper tantrums,” id. at 9; see also id. at 3 (reiterating Petitioners’ concern that their son
had experienced “significant developmental regression” following his June 2017 vaccinations).
He observed that C.J.B. was “apparently developmentally normal,” id. at 9, and ordered blood
tests to check C.J.B.’s liver and kidney function, id. at 6. Dr. Magnusson also recommended that
Petitioners take their son to see a developmental pediatrician. Id. at 9.
The record reflects that Dr. Magnusson called Petitioners to follow up a few days later,
leaving a voicemail on October 9, 2017, and speaking with C.J.B.’s father the following day. See
id. at 25–42. Petitioners told Dr. Magnusson that C.J.B.’s mood had improved, and he reiterated
his recommendation that they take C.J.B. to a developmental pediatrician. Id. at 35. He noted
that C.J.B.’s father “disagree[d] with [the Children’s Hospital of Philadelphia] info and
resources.” Id. at 35 (noting Petitioner’s belief that C.J.B.’s “[t]ooth grinding [was] symptomatic
of heavy metal poisoning” and that “[l]ow zinc [is] associated with aluminum”). Dr. Magnusson
recommended a multivitamin and that some of C.J.B.’s blood laboratory tests be repeated in two
or three months. Id.
Two weeks later, at his eighteen-month well-child visit on October 23, 2017, C.J.B.’s
pediatrician noted that Petitioners were concerned that he had “stopped talking” since his
vaccinations. Pet’rs’ Ex. 3, at 108. Specifically, Petitioners told the pediatrician that C.J.B.
currently had a vocabulary of two or three words, although he had initially gone “down to only
saying [one] word” the week following his vaccination. Id. (noting that “mom states ever since
[his June] immunizations he has stopped talking” and began “having tantrums, biting, hitting,
throwing toys and high pitched screaming”). The pediatrician observed that C.J.B.’s physical
exam was normal. Id. at 110. C.J.B.’s mother requested that his mineral and vitamin levels be
tested and expressed her concerns about aluminum. Id. at 111. Noting that providers at the
Children’s Hospital of Philadelphia had opined that C.J.B.’s “toxicology levels are not a
problem,” the pediatrician reiterated to Petitioners the recommendation that they follow up with
a developmental pediatrician. Id.
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A month later, on November 24, 2017, C.J.B.’s parents sought treatment with a new
pediatrician, Dr. David Bruner. Pet’rs’ Ex. 11, at 7, ECF No. 17-1; id. at 9 (noting that C.J.B.
was there to “follow up [on] other office and [emergency department] visits [regarding]
developmental regression presenting primarily as loss of most of his regressive language [and
the] new onset of aggressive behavior”). According to Dr. Bruner’s notes, Petitioners told him
that C.J.B. “was very fussy and irritable after his [six] month shots,”2 and that he “began to grind
[his] teeth which he subsequently ground through enamel now to point of needing [a] root
canal.” Id. at 9. They explained that C.J.B. “began to lose language milestones” around fifteen
months of age. Id. Dr. Bruner recorded Petitioners’ “concerns [about] possible aluminum
toxicity” and their belief that the results of C.J.B.’s aluminum blood tests were unusual. Id.
(noting that “serum and urine aluminum levels . . . do not have known agreed upon standards”).
He noted that C.J.B. “ha[d] not had a neurological evaluation or speech evaluation to date,” but
stated that the child was “[o]bservationally” normal. Id. at 9–10. He explained to Petitioners that
C.J.B. “[n]eed[ed] to begin speech therapy,” because, “regardless of [the] cause” of his speech
regression, he “likely has frustration over this which may lead to his outbursts.” Id. at 11. He
scheduled a follow-up exam with C.J.B. in six months. Id.
Although not memorialized directly in the record, C.J.B. was apparently seen by
developmental pediatrician Dr. McSween on December 29, 2017. See Pet’rs’ Ex. 9, at 2 (Dr.
McSween’s diagnosis of “speech abnormality” on that date), ECF No. 14-1; id. at 21 (noting a
diagnosis of “speech abnormality” on that date); id. at 7 (noting C.J.B.’s height and weight on
that date); id. at 12 (Dr. McSween’s order of that date scheduling an MRI on January 18, 2018,
for “encephalopathy” and diagnosing C.J.B. with “speech disturbance”).
IV. 2018 Medical Records
On January 18, 2018, Petitioners brought C.J.B. to Cooper University Hospital for the
MRI that Dr. McSween had ordered on December 29, 2017. Pet’rs’ Ex. 9, at 2–38. Dr.
Christopher Plymire recorded Petitioners’ concerns about vaccine-related “aluminum toxicity” as
allegedly demonstrated by C.J.B.’s “[d]evelopmental delay and regression.” Id. at 8, 23. The
results of the MRI were normal except for the discovery of a “thin-walled pineal gland cyst,”
which prompted the radiologist to recommend “[a] three to six-month follow-up MRI of the
brain with thin sections through the pineal gland.” Id. at 13.3
2 This observation is unaddressed by the parties and is the first and only time that a provider
suggested that C.J.B. had a reaction to any vaccine other than his June 23, 2017 fifteen-month
vaccinations.
3 The pineal gland is “a small, flattened cone-shaped body in the epithalamus, lying above the
superior colliculi and below the splenium of the corpus callosum.” Dorland’s Illustrated Medical
Dictionary (30th ed. 2003) at 774. A pineal cyst is a benign and rarely symptomatic growth
commonly found in the pineal region of the brain in both children and adults. Michael D.
Jenkinson, Samantha Mills, Conor L. Mallucci, & Thomas Santarius, Management of pineal and
colloid cysts, 21 Prac. Neurology 292, 292–93 (2021).
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On February 28, 2018, C.J.B. was seen by Dr. Jaya Ganesh at Cooper University Hospital
for an “initial genetic consultation . . . due to developmental regression presenting primarily as
loss of most of his expressive language and onset of aggressive behavior.” Pet’rs’ Ex. 7, at 4,
ECF No. 7-7. Petitioners told Dr. Ganesh they were concerned that C.J.B.’s developmental
regression was attributable to methylenetetrahydrofolate reductase (“MTHFR”) gene
polymorphisms. Id. She observed that C.J.B. met “normal growth parameters,” and that, “[w]hile
[his] expressive language is definitely behind for [his] age, he demonstrates age appropriate to
advanced gross and fine motor skills and interactive play.” Id. at 8 (concluding that “[a] genetic
etiology is not readily apparent”). She ordered a “[c]hromosomal micro array,” “MTHFR
polymorphism screening,” and “metabolic studies.” Id.; see also id. at 13–18 (lab orders and
results).
The next medical record is from May 24, 2018, when C.J.B. saw Dr. Bruner again for his
two-year well-child visit. Pet’rs’ Ex. 11, at 28–43. Dr. Bruner noted that C.J.B.’s “family reports
he had a brief language regression that improved after glutathione (managed by outside
provider).” Id. at 30. He also noted that C.J.B. was “due for a repeat MRI due to pineal cyst,” and
further that C.J.B.’s “family belie[ves] he has increase flare on MRI,” which was “noted in [a]
report from [pediatric] radiology as age appropriate,” although C.J.B.’s parents “d[idn’t]
necessarily agree with this” assessment. Id.
On July 24, 2018, C.J.B. was seen at Cooper University Hospital for the follow-up MRI
to observe the pineal gland cyst discovered in January. Pet’rs’ Ex. 9, at 39–74. The next medical
record is from December 26, 2018, when C.J.B.’s pediatrician treated him for a cough and runny
nose. Pet’rs’ Ex. 11, at 44–54.
V. Pertinent Medical Records for 2019, 2020, and 2021
C.J.B. saw Dr. Bruner again on April 29, 2019, for his three-year well-child visit. Pet’rs’
Ex. 11, at 55–66. Dr. Bruner noted that C.J.B.’s parents “ha[d] not contacted [his] school for
[evaluation],” even “though multiple speech concerns persist.” Id. at 57. He further noted that
Petitioners believed that the MRIs demonstrated an encephalopathy, but that, in his opinion,
those tests “read as normal other than a small stable pineal cyst [observed] by our Pediatric
Radiology department.” Id. at 57; id. at 60 (noting that Petitioners were “also looking for a
neurologist to look at the MRI’s”). He advised C.J.B.’s parents to get an evaluation from his
school because he was “concerned that a gap in therapies is not good for him.” Id. at 60.
On July 8, 2019, Petitioners again brought C.J.B. to see Dr. Bruner, reporting that he was
experiencing “daily” headaches and “gets motor tics like head shake when tired.” Id. at 79–84;
see id. at 80 (C.J.B. “told his family his head hurts during these episodes” which “occur daily
and will awaken him at night”). Dr. Bruner noted that the third MRI he had ordered to monitor
the pineal gland cyst had not been performed, and that he would work on getting it authorized in
light of these “new [findings] of headache awakening him from sleep.” Id. at 80, 83.
C.J.B. underwent a third MRI on July 30, 2019. Pet’rs’ Ex. 9, at 75–124. His providers
noted that the pineal gland cyst which had been discovered in January 2018 was “stable,” and
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there were no other abnormalities noted. Id. at 87 (noting that “myelination is within range for
age”).
On December 3, 2019, C.J.B. was seen by pediatric neurologist Dr. Stephen Falchek,
who documented the family’s concerns and C.J.B.’s medical history. Pet’rs’ Ex. 5, at 5–7, ECF
No. 7-5. Petitioners told Dr. Falchek that C.J.B. had been “very vocal . . . until about
[twenty-four] hours after his [fifteen-]month immunizations,” at which point “he began to
display [behavior] consistent with pain and temper tantrums.” Id. at 5. C.J.B.’s father also told
Dr. Falchek that the first 2018 MRI showed “FLAIR abnormality all over.” Id.
Dr. Falchek “discuss[ed] with [the] family the fact that FLAIR images in [the MRI scans
of very] young children show the areas of ongoing myelination as bright areas,” and accordingly
“can be mistaken as abnormal.” Id. at 7. Nevertheless, he noted that he would “try to have our
neuroradiologists review [the MRIs].” Id. He also noted that the blood and urine tests conducted
by the Children’s Hospital of Philadelphia showed that C.J.B.’s “total aluminum level was 3,
well within the normal range,” and that his “aluminum/creatinine ratio was 33 mcg/gr
creatinine,” which “is also within normal limits.” Id. (noting that this test result “has caused
some confusion as it was being interpreted as a total aluminum level, which it isn’t”). Dr.
Falchek reiterated the recommendation made by C.J.B.’s other providers that his parents consult
with a speech therapist. Id.
On February 6, 2020, C.J.B. began treatment with Samantha Dommermuth, a
speech-language pathologist. Id. at 12–20. She observed that C.J.B. displayed “mild receptive
and expressive language delay in combination with mild speech sound delay,” but found “little to
no evidence of dyspraxia.” Id. at 18. She recommended that C.J.B. receive speech and language
therapy weekly for thirteen weeks, id., and the record demonstrates that she saw him at least two
more times, id. at 21–27 (medical records of speech and language therapy with Ms.
Dommermuth on March 2 and March 9).
Dr. Falchek saw C.J.B. via video on April 14, 2020. Id. at 9–11. The report notes the
purpose of the appointment was “for follow-up of chronic encephalopathy.” Id. at 9 (noting
C.J.B.’s “rather complex and confusing medical history”). Dr. Falchek noted that the results of
C.J.B.’s blood and urine tests were all normal and that, although he had only been able to obtain
one of C.J.B.’s three MRIs, he “concur[red]” that it “was probably normal.” Id. at 10.
During this visit, Petitioners told Dr. Falchek that C.J.B. had experienced “[r]ecent
regression in counting skills,” as well as “cognitive and behavioral regression,” and that his
“speech [was] increasingly slurred.” Id. Dr. Falchek’s notes conclude with a recitation of his
“[i]mpression” of C.J.B.’s condition, which he characterized as “complex encephalopathy with
history of developmental regression in the context of immunizations and febrile illness.” Id. at
11.
On October 6, 2020, Dr. Bruner saw C.J.B. for his four-year well-child visit. Pet’rs’ Ex.
13, at 3–22, ECF No. 36-1. He noted that C.J.B. had begun “speech therapy and now
occupational therapy,” and his mother “report[ed] he has made very good progress of late.” Id. at
6 (noting that his mother “is thrilled with his progress”). She told Dr. Bruner that C.J.B.’s
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“speech is coming along,” as were his “[f]ine motor and gross motor skills . . . [and] sensory
issues.” Id.
The most recent medical record provided by Petitioners is a one-paragraph letter signed
by Dr. Bruner, addressed “[t]o whom it may concern” and dated March 13, 2021. Pet’rs’ Ex. 12,
at 2, ECF No. 34-1. In it, Dr. Bruner states that when he first met C.J.B. in 2017, the child “was
experiencing a significant developmental regression.” Id. He further states that a “broad based
medical and neurological evaluation” was conducted and that the neurological evaluation
“raise[d] . . . concerns about the developmental regression occurring probably as a result of
intense immune reactions he had to his vaccinations.” Id. “[D]ue to these reactions,” Dr. Bruner
stated, C.J.B. should be treated as “medically exempt from further vaccination.” Id.
VI. The Vaccine Claim
In the meantime, on June 22, 2020, C.J.B.’s parents filed a petition for compensation
pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-1 to -34.
Pet. for Comp. at 1, ECF No. 1. In their petition, Mr. Bello and Ms. Oganesov alleged, among
other things, that the vaccines C.J.B. received on June 23, 2017, caused him to experience
encephalopathy, speech abnormality, and language regression. Id.4
The case was assigned to Chief Special Master Brian H. Corcoran on June 22, 2020. ECF
No. 4. After having received several extensions of time to do so, Petitioners filed their affidavit
as well as medical records on August 26, 2020, and on November 13, 2020. ECF Nos. 7, 14.
They filed their Statement of Completion on November 13, 2020, in accordance with Vaccine
Rule 2(f). ECF No. 16.5
VII. The Show Cause Order
On February 24, 2021, over three months after Petitioners filed their Statement of
Completion, Chief Special Master Corcoran held a status conference in the case. During the
conference he expressed concerns regarding whether the medical record supported Petitioners’
claims that the vaccines C.J.B. received on June 23, 2017, caused him to develop
encephalopathy, speech abnormality, language regression and/or significant aggravation of an
underlying condition. See Order to Show Cause at 1, ECF No. 29.
4 The Petition also alleged that the vaccines had “aggravat[ed] . . . an underlying condition
[caused by] the genetic mutation MTHFR,” Pet. for Comp. at 1, but Petitioners did not pursue
that claim before the Chief Special Master.
5 Vaccine Rule 2(f) provides that a “[p]etitioner should file a ‘Statement of Completion,’
indicating that a certified copy of all medical and other records relevant to the petition has been
filed, as soon as possible after the petition is filed,” and that “[i]f additional medical records or
other documents are necessary to complete the record, petitioner should delay filing the
Statement of Completion until all necessary and relevant records have been filed.”
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He followed up the next day with an Order directing Petitioners to show cause why their
claim should not be dismissed. Id. at 2. The Chief Special Master acknowledged that “in rare
circumstances, claimants have successfully demonstrated that a vaccine could precipitate an
encephalopathy in an infant, leading to similar kinds of injuries.” Id. at 1. He observed, however,
that such claims are “far more often than not unsuccessful” because claimants are usually unable
to produce medical evidence that the infant experienced an acute injury in the days immediately
after they were vaccinated. Id. at 2. Instead, he stated, they rely on parents’ recollection of
behavioral changes that are not corroborated by medical records. Id.
The Chief Special Master’s “initial and admittedly cursory review of the medical records
filed in this case” suggested to him that the Petitioners’ claims were not likely to succeed for two
reasons: (1) because the records “do not seem to support the conclusion that the onset of C.J.B.’s
condition occurred within a reasonable timeframe following receipt of the June 23, 2017
vaccines”; and (2) because it did not appear that C.J.B. “ever received an encephalopathy
diagnosis from a contemporaneous treater.” Id.
In light of these concerns, the Chief Special Master directed Petitioners to file written
briefs explaining how the evidence in the record supported their claim that C.J.B. suffered an
injury as a result of the vaccine he received on June 23, 2017. Id. In doing so, he directed, they
should identify decisions under the Vaccine Act that found entitlement under facts consistent
with those supporting their claim. Id. If the Petitioners were unable to support their claims with
sufficient facts, he warned, he might find it appropriate to dismiss their claims on the existing
record. Id.
VIII. Petitioners’ Response to the Show Cause Order
Over two months later, on April 30, 2021, Petitioners filed their response to the Chief
Special Master’s Order. See Br. in Support of Pet’r’s Claim and in Resp. to Order to Show Cause
(“Pet’rs’ Resp. to Show Cause Order”), ECF No. 33. In it, they asserted (without citation to any
evidence in the record) that C.J.B. began to lose his speech “[w]ithin hours of receiving the
vaccines,” and that, “[f]or several days thereafter, [C.J.B.’s] number of words decreased each
day.” Id. at 2.
Petitioners’ Response also included brief quotes or excerpts from a number of the
medical records they had submitted. Those records reflected that, as described above, Petitioners
first reported concerns about C.J.B.’s loss of language in an August 28, 2017 call to his
pediatrician. Id.6 The Response also asserts that Petitioners were awaiting “updated medical
records.” Id. at 4. In addition, the Response emphasized that it was “[o]f utmost importance” that
“not one Emergency room doctor, pediatrician, or specialist ever diagnosed C.J.B. with Autism.”
Id. at 5.
6 The Response also states that C.J.B. made an earlier visit to Children’s Hospital of Philadelphia
on July 19, 2017, during which Petitioners reported decreased speech by C.J.B., as well as other
issues (biting mother, throwing toys). See Pet’rs’ Resp. to Show Cause Order at 2. That visit,
however, took place on September 19, 2017, not July 19, as was misstated in the Response.
Pet’rs’ Ex. 8, at 7.
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In their Response, Petitioners also advised the Chief Special Master that C.J.B.’s case
was under “preliminary review” by Dr. Yuval Shafrir, a pediatric neurologist. Id. at 6. They
stated that Dr. Shafrir had not yet been retained, and that his “initial opinion [was] that C.J.B.’s
diagnoses are not autism.” Id. at 6–7.
Petitioners asserted that, as of the time they filed their Response, “there is a temporal
relationship and a clear diagnosis.” Id. at 7. They requested that they “be given the opportunity to
further consult with Dr. Shafrir,” whom they represented would “assist in establishing the
causation-in-fact prong, set forth in Althen, that the vaccines caused C.J.B.’s encephalopathy,
initial complete loss of speech, and current extremely slurred version of speech.” Id.
Petitioners filed the additional updated medical records they referenced in their Response
on May 5 and 7, 2021. See ECF Nos. 34, 36. On June 28, 2021, the Secretary of Health and
Human Services (“the Secretary”) filed a reply to Petitioners’ Response to the Show Cause
Order. Resp’t’s Br. in Reply to Pet’rs’ Resp. to Order to Show Cause (“Resp’t’s Reply to Show
Cause Order”), ECF No. 39. The Secretary argued that Petitioners failed to address the concerns
set forth in the Chief Special Master’s Order, and that their claim should be dismissed because
they had failed to provide any evidence to support it. Id. at 1, 15. Petitioners filed their reply on
August 12, 2021. Reply Br. in Support of Pet’rs’ Claim and in Resp. to Order to Show Cause,
ECF No. 42.
IX. Ruling on Entitlement
The Chief Special Master issued his entitlement decision on September 10, 2021.
Entitlement Dec. at 1, ECF No. 43. He ordered the case dismissed because he found that
“Petitioners cannot demonstrate based on the medical record that C.J.B. experienced the kind of
true ‘encephalopathy’ required in Program non-Table cases to find subsequent developmental
regression associated with it.” Id. at 2. He explained that “[t]he vaccines C.J.B. received could
only ‘cause’ language loss if they first harmed the brain – so a finding of this having occurred is
a prerequisite to a favorable entitlement finding.” Id. at 15. He concluded that there did not exist
preponderant evidence showing that C.J.B. “suffered an encephalopathy in any reasonable
post-vaccination timeframe.” Id.
The Chief Special Master explained that, in his view, the medical records “do not
establish anything close to suggesting a brain injury sufficient to lead to any form of
developmental delay or regression,” and noted that there were “no instances in which C.J.B.
received emergency care from June to the fall of 2017 not prompted by Petitioners’ personal
concerns about vaccine metal toxicity or language loss.” Id. He further found that there was no
evidence that C.J.B. experienced either a loss of consciousness or seizures “in this period
[which] might have reflected the existence of an encephalopathic event, and no treaters who saw
him in the six months after vaccination proposed otherwise.” Id.
The Chief Special Master also explained that he was exercising his discretion to decide
the case on the basis of the existing record and without holding a hearing, as permitted by
Section 12(d)(2)(D) of the Vaccine Act and Vaccine Rule 8(d). Id. at 13, 17–19. He observed
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that a review of the cases showed that no claimant had successfully demonstrated
vaccination-precipitated encephalopathy absent a showing of evidence of a seizure or medical
reports of the emergence of symptoms of acute encephalopathy in the forty-eight hours after
vaccination. Id. at 17. Further, he observed that the record revealed that Petitioners were
concerned “that metal toxicity, due to aluminum included as an adjuvant in some of the vaccines
C.J.B. received, could have prompted injury.” Id. at 18 (footnote omitted). But this theory, he
noted, “has also uniformly been rejected in the [Vaccine] Program as an explanation for
developmental issues due to a brain injury.” Id.; see also id. n.8 (citing Rogero v. Sec’y of Health
& Hum. Servs., No. 11-770V, 2017 WL 4277580 (Fed. Cl. Spec. Mstr. Sept. 1, 2017), aff’d, 748
F. App’x 996 (Fed. Cir. 2018); Bushenell v. Sec’y of Health & Hum. Servs., No. 02-1648V,
2015 WL 4099824 (Fed. Cl. Spec. Mstr. June 12, 2015)).
Finally, the Chief Special Master advised that he saw no reason to allow Petitioners to
provide the testimony of an expert witness, as they requested in their response to the Show Cause
Order. Id. at 18. While he acknowledged that Petitioners “could no doubt find an expert willing
to advocate for them . . . such efforts would run head-on into an absence of persuasive,
contemporary medical support for the conclusion that C.J.B. likely experienced any kind of
vaccine-induced injury sufficient to cause developmental problems.” Id. “Thus,” he reasoned,
“allowing that process to occur (which would also entail Respondent likely seeking to offer a
rebuttal expert of his own) would waste time and Program resources.” Id. at 18–19.
X. Motion for Review
Petitioners filed their motion for review of the Chief Special Master’s Decision on
October 9, 2021. See Mot. for Review, ECF No. 46; Pet’r’s Mem. in Support of his Mot. for
Review (“Pet’rs’ Mot.”), ECF No. 46-1. In their motion, they contend that the Chief Special
Master abused his discretion by dismissing the case without holding an evidentiary hearing or
giving them an opportunity to submit an expert report. Id. at 5–6, 12–13. They also argue that the
Chief Special Master gave insufficient weight to evidence in the record that they say supports a
diagnosis of an encephalopathy that was caused by the vaccinations C.J.B. received in June
2017. Id. at 14–15.
The Secretary filed his response on November 8, 2021. Resp’t’s Resp. to Pet’rs’ Mot. for
Review (“Sec’y’s Resp.”), ECF No. 49. On February 22, 2022, three days before oral argument
on their motion for review, Petitioners filed a motion for leave to file “telephone records
indicating phone calls made by the parents to the pediatrician during the initial time frame of
Petitioner’s injury.” Mot. for Leave to File Add’l Docs. at 1, ECF No. 51. Oral argument was
held on both motions via videoconference on February 25, 2022.
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DISCUSSION
I. The Vaccine Act
A. Proving Entitlement
Congress established the National Vaccine Injury Compensation Program in 1986 to
provide a no-fault compensation system for vaccine-related injuries and deaths. Figueroa v.
Sec’y of Health & Hum. Servs., 715 F.3d 1314, 1316–17 (Fed. Cir. 2013). There are two routes
by which a petitioner may establish entitlement to compensation under the Vaccine Act.
First, in a so-called “Table” case, a petitioner may secure compensation by showing
that—within specified time periods after receiving one of the vaccines identified in the Vaccine
Injury Table—he “sustained” or “significantly aggravated” an “illness, disability, injury, or
condition” identified in the Table. See Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d
1339, 1341–42 (Fed. Cir. 2010); 42 U.S.C. § 300aa-11(c)(1)(C)(i). If a petitioner makes this
showing, it is presumed that the vaccine caused his injury. Broekelschen, 618 F.3d at 1341–42
(citing 42 U.S.C. § 300aa-11(c)(1)(C)(i)); Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d
1367, 1374 (Fed. Cir. 2009)).
In an off-Table case, on the other hand, a petitioner establishes his entitlement to benefits
by first identifying and establishing the injury that he claims he has suffered as a consequence of
the vaccine, and then proving by preponderant evidence that the vaccine caused the injury. 42
U.S.C. §§ 300aa-11(c)(1), -13(a)(1)(A); see also Andreu, 569 F.3d at 1374; Broekelschen, 618
F.3d at 1346. “[A] petitioner must show that the vaccine was not only a but-for cause of the
injury but also a substantial factor in bringing about the injury.” Stone v. Sec’y of Health &
Hum. Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012) (quotations omitted).
The three-pronged test that the Federal Circuit announced in Althen v. Secretary of
Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005), guides the causation determination in
an off-Table case. It requires a petitioner to demonstrate: (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 proximate temporal relationship
between vaccination and injury.” Id. at 1278. “Once the petitioner has demonstrated causation
[under Althen], she is entitled to compensation unless the government can show by a
preponderance of the evidence that the injury is due to factors unrelated to the vaccine.”
Broekelschen, 618 F.3d at 1342 (citing Doe v. Sec’y of Health & Hum. Servs., 601 F.3d 1349,
1351 (Fed. Cir. 2010)); see also 42 U.S.C. § 300aa-13(a)(1)(B).
B. Jurisdiction and Standards of Review
A petition seeking compensation under the Vaccine Act must be filed in the Court of
Federal Claims, after which it will be forwarded to the Office of Special Masters for assignment.
42 U.S.C. § 300aa-11(a)(1). The special master to whom the petition is assigned is responsible
for deciding whether the petitioner is entitled to compensation, and, if so, the amount of
compensation due. Id. § 300aa-12(d)(3)(A).
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The Vaccine Act grants the Court of Federal Claims jurisdiction to review the decisions
of special masters (subject to further review in the Federal Circuit). 42 U.S.C. §§ 300aa-12(e),
(f); see also Mahaffey v. Sec’y of Health & Hum. Servs., 368 F.3d 1378, 1383 (Fed. Cir. 2004)
(citing 42 U.S.C. § 300aa-12(d)(3)(A)). On review, the Court has several options. It may:
(A) uphold the findings of fact and conclusions of law of the special master and
sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the special master
found to be arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law and issue its own findings of fact and conclusions of
law, or
(C) remand the petition to the special master for further action in accordance
with the court’s direction.
42 U.S.C. § 300aa-12(e)(2); see also Vaccine Rule 27.
The Court applies the “not in accordance with law” standard when reviewing a special
master’s legal determinations. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321
(Fed. Cir. 2010). Such review is de novo. Althen, 418 F.3d at 1278–79. The reviewing court
“give[s] no deference to the . . . Special Master’s determinations of law.” Carson v. Sec’y of
Health & Hum. Servs., 727 F.3d 1365, 1368 (Fed. Cir. 2013).
By contrast, review of a special master’s factual determinations is to decide whether they
are arbitrary, capricious, and/or reflect an abuse of discretion. Moberly, 592 F.3d at 1321. The
Court applies a “uniquely deferential” standard to those determinations. Milik v. Sec’y of Health
& Hum. Servs., 822 F.3d 1367, 1376 (Fed. Cir. 2016) (quoting Hodges v. Sec’y of Health &
Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). It does not reweigh the evidence; nor does it or
examine its probative value or the credibility of the witnesses, because those “are all matters
within the purview of the fact finder.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242,
1249 (Fed. Cir. 2011) (citing Broekelschen, 618 F.3d at 1349). Therefore, if a special master
“‘has considered the relevant evidence of record, drawn plausible inferences and articulated a
rational basis for the decision,’ then reversible error is ‘extremely difficult to demonstrate.’”
Milik, 822 F.3d at 1376 (quoting Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528
(Fed. Cir. 1991)).
II. Petitioners’ Motion for Review
In their motion for review, the Petitioners assert that—contrary to the Chief Special
Master’s findings—the medical record contains persuasive evidence that C.J.B. suffered from a
chronic encephalopathy caused by his immunizations. Pet’rs’ Mot. at 8. Moreover, they contend,
the Chief Special Master abused his discretion by dismissing their claims without holding an
evidentiary hearing or receiving an expert report. Id. at 7–8. Had the Chief Special Master not
dismissed the case on the existing record, they say, they might have been able to fill the gaps in
proof that concerned him. Id. at 9, 11.
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Petitioners’ arguments are unpersuasive. First, the Chief Special Master’s determination
that Petitioners did not prove C.J.B. suffered a vaccine-related encephalopathy was supported by
the evidence before him. As he observed, to prove that the vaccines C.J.B. received on June 23,
2017, caused him to lose speech capabilities, Petitioners would first have to show an injury to
C.J.B.’s brain. Entitlement Dec. at 15. In addition, he noted—and Petitioners do not disagree—
“the critical timeframe” to establish a causal relationship between the vaccine and any brain
injury was “within the first month of vaccination.” Id.
The Chief Special Master reviewed the medical records Petitioners supplied and found
that they “do not establish anything close to suggesting a brain injury sufficient to lead to any
form of developmental delay or regression,” observing that there were “no instances in which
C.J.B. received emergency care from June to the fall of 2017 not prompted by Petitioners’
personal concerns about vaccine metal toxicity or language loss.” Id. Further, he found, there
was no evidence that C.J.B. “ever had any change in consciousness in this period that might have
reflected the existence of an encephalopathic event, and no treaters who saw him in the six
months after vaccination proposed otherwise.” Id. There was also no evidence C.J.B. had ever
suffered seizures which could have caused brain injury sufficient to cause the speech regression
his parents had observed. Id. at 15, 17.
The Chief Special Master gave no weight to the allegations in Petitioners’ affidavit that
C.J.B.’s health “rapidly declined” after he received the June 23, 2017 vaccination and that he
was “crying constantly” and “began having ‘fits’ every 3-5 minutes” after coming home from the
doctor’s office that day. Pet’rs’ Ex. 2. ¶¶ 4–5; see Entitlement Dec. at 16. Nor did he credit their
assertion that C.J.B. lost his ability to speak entirely within three weeks of receiving the
vaccines. See Pet’rs’ Ex. 2 ¶ 6; Entitlement Dec. at 16. Those assertions were not credited
because they were not reflected in the many medical records documenting C.J.B.’s speech
difficulties in the months that followed his vaccinations. Entitlement Dec. at 16.
As the court of appeals has observed, medical records “warrant consideration as
trustworthy evidence” because they “contain information supplied to or by health professionals
to facilitate diagnosis and treatment of medical conditions,” and are “generally contemporaneous
to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed.
Cir. 1993). They are prepared when the patient’s “proper treatment [is] hanging in the balance”
and “accuracy has an extra premium.” Id.
In this case, Petitioners routinely called the pediatrician or sought treatment for C.J.B. for
a broad range of health concerns, both before and after he received the June 23, 2017 vaccines.
The Chief Special Master’s decision to accord more weight to contemporaneous medical records
was therefore appropriate, and reflects the “familiar and reasonable assessment that
contemporaneous documentary evidence of the sort at issue here, prepared by professionals
doing their jobs independently of litigation, can be (though is not necessarily) more reliable than
testimony of interested parties.” Rogero v. Sec’y of Health & Hum. Servs., 748 F. App’x 996,
1001 (Fed. Cir. 2018) (citing Reusser v. Sec’y of Health & Hum. Servs., 28 Fed. Cl. 516, 523
(1993) (stating that “written documentation recorded by a disinterested person at or soon after
the event at issue is generally more reliable than the recollection of a party to a lawsuit many
years later”)); Skinner v. Sec’y of Health & Hum. Servs., 30 Fed. Cl. 402, 410 (1994) (“In
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general, contemporaneous written records are to be given more weight than testimony adduced
years later.”).
The Chief Special Master also found it significant that none of the medical professionals
who treated C.J.B. in the months following his vaccinations diagnosed him as suffering from an
encephalopathy. Entitlement Dec. at 15. Petitioners fault the Chief Special Master for not giving
greater weight to Dr. Falchek’s report (which provided his “impression” that C.J.B. had
experienced “complex encephalopathy with history of developmental regression in the context of
immunizations and febrile illness.”). Pet’rs’ Mot. at 14 (quoting Pet’rs’ Ex. 5, at 11). But the
Chief Special Master reasonably found this evidence not especially helpful to Petitioners. To
begin with, Dr. Falchek saw C.J.B. more than two years after he received the vaccinations in
question. Entitlement Dec. at 15. In addition, his impression regarding the existence of a
“complex encephalopathy” does not appear to be supported by objective evidence. Id.
(explaining that this impression “rel[ies] on Petitioners’ reported history rather than the record
filed in this case, which are inconsistent with what he was told”).
Petitioners’ reliance upon Dr. Falchek’s reported impression is also undermined by the
two pages of notes that preceded it. See Pet’rs’ Ex. 5, at 9–10. In those notes, Dr. Falchek
characterized C.J.B.’s medical history as “complex and confusing,” and stated that his medical
records demonstrated that the three MRIs he underwent were normal. Id. It appears, therefore,
that the sole bases for Dr. Falchek’s impression regarding the “complex encephalopathy” were
Petitioners’ assertions. See id.; see also Entitlement Dec. at 15.7
Perhaps recognizing the weakness of their case on the existing record, Petitioners focus
most of their motion for review on the Chief Special Master’s decision to dismiss the case
without holding an evidentiary hearing. They contend that had he held such a hearing, they could
have testified as to the “onset of encephalopathy” and “phone calls to the pediatrician’s office
that were unfortunately omitted from the medical record, as well as information that was
incorrectly set forth in the medical record.” Pet’rs’ Mot. at 6, 9. They also argue that the Chief
Special Master should have granted their request for additional time to submit an expert report
by Dr. Yuval Shafrir. Id. at 6, 13. These contentions are unavailing.
Special masters have broad discretion to determine how best to manage the cases before
them. Vaccine Rule 3(b) states that “[t]he special master is responsible for conducting all
proceedings” and “shall determine the nature of the proceedings, with the goal of mak[ing] the
proceedings expeditious, flexible, and less adversarial.” Further, under Vaccine Rule 8(a), the
special master has discretion to “determine the format for taking evidence and hearing argument
7 In their motion, Petitioners contend that C.J.B.’s MRIs “showed significant ‘brain flare’” and
argue that if Dr. Shafrir had been retained, he could have provided an expert opinion “whether
brain flares are consistent with Encephalopathy of the brain” as well as potentially its onset.
Pet’rs’ Mot. at 14. They provide no citation to the record that supports their assertion regarding
evidence of “significant ‘brain flare’” in the MRIs. Dr. Falchek’s report states that C.J.B. was
evaluated at Children’s Hospital of Philadelphia and that in his father’s opinion the MRI
“showed ‘FLAIR abnormality all over’” but that “the final report was normal.” Pet’rs’ Ex. 5, at
9–10 (Dr. Falchek’s notes apparently quoting C.J.B.’s father).
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based on the specific circumstances of each case and after consultation with the parties.” And
Vaccine Rule 8(d) expressly states that “[t]he special master may decide a case on the basis of
written submissions without conducting an evidentiary hearing.”
To be sure, special masters are obligated to “consider all relevant and reliable evidence”
and the proceedings must be “governed by principles of fundamental fairness to both parties.”
Vaccine Rule 8(b). Special masters also “must determine that the record is comprehensive and
fully developed before ruling on the record.” Kreizenbeck v. Sec’y of Health & Hum. Servs., 945
F.3d 1362, 1366 (Fed. Cir. 2020). But so long as the special master follows these general
principles, decisions regarding the management of a case are left to his discretion and subject to
reversal only under the highly deferential abuse of discretion standard. Id. at 1364.
In this case, the Chief Special Master gave Petitioners a full and fair opportunity to
present written evidence and argument. Petitioners were afforded several extensions of time to
submit their affidavits and medical records, and they ultimately filed a Statement of Completion,
signaling that all supporting records had been submitted. See ECF Nos. 16, 19. The record before
the Chief Special Master contained reports from all of the medical providers who saw C.J.B.
about his speech regression and other health issues in the months and years after his vaccination.
In addition, the Chief Special Master expressly gave Petitioners a chance to address the
difficulties that are commonly presented when claimants attempt to prove that vaccines have
caused developmental issues like those C.J.B. experienced. He warned them that, in his
experience, “this kind of case is far more often than not unsuccessful,” and explained that
“claimants usually cannot establish that the infant or child vaccinee experienced any acute injury
in the immediate days after vaccination, and instead rely mainly on parent recollection of
post-vaccination behavioral changes that are not corroborated by contemporaneous medical
records.” Show Cause Order at 2. He therefore invited Petitioners to identify medical evidence
that C.J.B. had suffered an encephalopathy and that it had caused the developmental problems
they had observed.
Instead, in their response to his Order, Petitioners took precisely the approach the Chief
Special Master warned them against. They relied almost exclusively on their own observations of
C.J.B.’s language regression, and their efforts to secure treatment, as set forth in the medical
evidence of record. See Pet’rs’ Resp. to Show Cause Order. They also emphasized the fact that
none of the medical evidence showed an autism diagnosis. Id. at 5, 7. What they did not do was
point to medical evidence that reflected that C.J.B. suffered a brain injury that might have cause
his speech regression.
The Court finds unpersuasive Petitioners’ contentions that the Chief Special Master
should have held an evidentiary hearing at which they could have provided testimony about the
onset of C.J.B.’s injuries and what they now claim were errors or omissions in the medical
records. See Pet’rs’ Mot. at 9, 11, 13. For one thing, Petitioners had the opportunity but never
advised the Chief Special Master that there were errors in the medical records either in the
affidavit they originally filed in their case, or in response to the Chief Special Master’s Show
Cause Order. Moreover, and in any event, the flaw that the Chief Special Master identified in
their case was the absence of medical evidence showing an encephalopathy. Petitioners’
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testimony regarding their observations would not fill that gap, and would likely not be found
persuasive in any event to the extent that they differed from those provided contemporaneously
to C.J.B.’s medical providers.
Nor did the Chief Special Master abuse his discretion when he determined that it was not
necessary to permit Petitioners to retain and submit testimony from an expert. The Chief Special
Master concluded that expert testimony would not be sufficient to overcome “an absence of
persuasive, contemporary medical support for the conclusion that C.J.B. likely experienced any
kind of vaccine-induced injury sufficient to cause developmental problems.” Entitlement Dec. at
18.
The Chief Special Master, in short, found that the record did not support a finding that
C.J.B. suffered a brain injury. Therefore, Petitioners could not link the developmental symptoms
that manifested themselves after vaccination to the vaccines he received. The Chief Special
Master’s factual findings were reasonable and supported by the record before him. His decision
not to hold an evidentiary hearing or consider expert testimony represents a reasonable exercise
of his discretion to decide how to manage the case and did not deprive Petitioners of a full and
fair opportunity to have their claims heard. Petitioners’ motion for review must therefore be
denied.
III. Motion to Submit Additional Phone Records
Finally, on February 22, 2022, three days before oral argument on their motion for
review, Petitioners filed a motion for leave to file “telephone records indicating phone calls made
by the parents to the pediatrician during the initial time frame of [C.J.B.’s] injury.” Mot. for
Leave to File Add’l Docs. at 1. As explained above, the Court’s review in Vaccine cases is based
on the record before the Chief Special Master. Moreover, Vaccine Rule 8(f)(1) provides that
“[a]ny fact or argument not raised specifically in the record before the special master will be
considered waived and cannot be raised by either party in proceedings on review of a special
master’s decision.” The Court cannot, therefore, grant Petitioners’ request that it consider
additional material not presented to the Chief Special Master.
To be sure, while the Court itself cannot consider new evidence, it has the discretion to
remand the case to the Chief Special Master with directions that he do so. 42 U.S.C. § 300aa-
12(e)(2)(C) (providing that the Court “shall have jurisdiction to undertake a review of the record
of the proceedings and may thereafter remand the petition to the special master for further action
in accordance with the court’s direction”); Shaw v. Sec’y of Health and Hum. Servs., 91 Fed. Cl.
715, 716 (2010) (remanding to the special master for the limited purpose of considering
previously available but newly presented evidence); Plavin v. Sec’y of Health & Hum. Servs., 40
Fed. Cl. 609, 621 (1998) (noting the court’s authority to direct the special master to consider
additional evidence). For several reasons, however, the Court believes that such a remand is not
warranted.
First, Petitioners have supplied no reasonable justification for not supplying the Chief
Special Master with the telephone records they would like the Court to admit into the record.
According to counsel, C.J.B.’s father recently obtained the records from his cell phone provider.
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See Oral Arg. at 1:58–3:58. They contain a list of the phone calls placed from the cell phone
beginning on July 26, 2017. Id. at 3:30–58. Because the records could have been secured from
the cell phone provider at any point before or while the claim was before the Chief Special
Master, in the Court’s view, Petitioners should not be permitted to submit them at this late
stage.8
Further, the relevance of the records to Petitioners’ claim is unclear at best. At oral
argument on Petitioners’ motions, Petitioners’ counsel stated that the cell phone provider’s
records reflect that C.J.B.’s father made calls to the pediatrician that the office did not record. Id.
at 4:03–20, 6:38–7:01. Specifically, counsel referenced four calls C.J.B.’s father made to the
pediatrician on September 1, 2017. Id. at 4:21–52. But two of those calls were only two minutes
long and so may well have represented calls answered by a receptionist and not medical
providers. Id. at 5:01–14. The other two calls were eleven and eighteen minutes long. Id. The
pediatrician’s records reflect those two calls and describe their substance. See Pet’rs’ Ex. 3, at
90–91.
Moreover, and in any event, records of phone calls placed but not recorded in medical
records starting on July 26, 2017, have no bearing on the Chief Special Master’s causation
determination because they do not cover the critical thirty-day time period that followed the
vaccinations. See Entitlement Dec. at 15. In addition, the central reason the Chief Special Master
found Petitioners’ case unpersuasive was because of the absence of an objectively supported
medical opinion showing C.J.B. suffered a brain injury within a reasonable time frame after he
received his vaccination. The phone records do not help Petitioners address this flaw. The Court
therefore will not remand this case to the Chief Special Master to consider the records Petitioners
seek to introduce.
CONCLUSION
On the basis of the foregoing, Petitioners’ motion for leave to file additional documents,
ECF No. 51, is DENIED. Petitioners’ motion for review, ECF No. 46, is also DENIED and the
Decision of the Chief Special Master is SUSTAINED. The Clerk is directed to enter judgment
accordingly.
IT IS SO ORDERED.
s/ Elaine D. Kaplan
ELAINE D. KAPLAN
Chief Judge
8 During oral argument on Petitioners’ motions, counsel for the Petitioners stated that she had not
provided the records to the Chief Special Master because of the supposedly fast pace of the
proceedings before him. Oral Arg. at 1:58–2:38, 10:29–43. The Court does not find counsel’s
justification for not supplying the records to the Chief Special Master especially persuasive. The
Chief Special Master issued his Show Cause Order on February 25, 2021, and did not dismiss the
case until September 10, 2021. There was ample time in that six- or seven-month period for
Petitioners to secure the records which are the subject of their motion.
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