Court Opinion

ID: 5125031
Source: CourtListenerOpinion
Date Created: 2021-11-10 18:02:21.398196+00
Date Added: 2024-06-11T08:22:46.261232
License: Public Domain

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 DECISION 1

          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).
        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
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

                                                3
    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.
                                                          4
 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.

                                                 5
       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.
                                                           6
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

                                                  7
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

                                                   8
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

                                                  9
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

                                                 10
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”).

                                                  11
        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.

                                                 12
         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 Decisions 5

        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.

                                                         13
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.
                                                        14
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

                                                  15
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)).

                                                         16
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.

                                                  17
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 adjuvant 8 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
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