Ramsey v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-1486V
Filed: March 13, 2023
PUBLISHED
Special Master Horner
TERRA RAMSEY, as mother and
natural guardian of C.R. as minor,
Encephalopathy; Autism; DTaP,
Petitioner, Hib, Pneumococcal vaccines;
v. Dismissal
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Braden Andrew Blumenstiel, The Law Office of Dupont & Blumenstiel, Dublin, OH, for
petitioner.
Voris Edward Johnson, U.S. Department of Justice, Washington, DC, for respondent.
DECISION 1
On June 17, 2021, petitioner, Terra Ramsey, filed a petition under the National
Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that C.R.
suffered dizziness, loss of equilibrium, hindered motor skills, uncontrollable crying,
decreased consciousness, and other neurological issues within 24 hours of his June 18,
2018 DTaP, Hib, and pneumococcal vaccinations. (ECF No. 1, pp. 1-2.) Petitioner
alleges C.R. eventually received diagnoses of encephalopathy and autism. (Id. at 3.)
For the reasons set forth below, I conclude that petitioner is not entitled to an award of
compensation.
1
Because this decision contains a reasoned explanation for the special master’s action in this case, it will
be posted on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.
If the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
2
Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10-34.
1
I. Procedural History
As noted above, petitioner alleges that C.R. was ultimately diagnosed with
encephalopathy and autism spectrum disorder (“ASD”). (Ex. 5; Ex. 16, pp. 135-73.)
The encephalopathy diagnosis was not indicated in the medical records filed with the
petition; however, one of C.R.’s pediatricians, Carl Backes, D.O., provided a letter dated
January 14, 2020, in support of petitioner’s post-vaccination encephalopathy allegation.
(Ex. 7; see also Ex. 5.)
On June 3, 2022, this case was assigned to my docket. (ECF No. 19.) On June
23, 2022, a status conference was held. I held the status conference in lieu of issuing
an Initial Order to underscore to petitioner’s counsel that I had serious concerns
regarding the viability of this case. During the call, I discussed those concerns in detail.
That discussion is memorialized in the resulting Scheduling Order of June 24, 2022.
(See ECF No. 21.) Among other issues, I explained that
In his letter Dr. Backes observes that C.R. had normal neurologic exams at
multiple office visits on 5/04/2017, 5/19/2017, 7/20/2017, 9/20/2017,
10/05/2017, 11/07/2017, 11/13/2017, 12/14/2017, 1/19/2018, 3/15/2018,
5/04/2018, and 6/18/2018. (Ex. 7, p. 1.) He also references post-vaccination
encounters of 8/3/2018 and 9/18/2018 without description, as well as a
10/26/2018 encounter at which he received a parental report apparently
concerning for encephalopathy. (Id.)
(ECF No. 21, p. 1.) I further noted, however, that Dr. Backes’ encounter records had
not been filed and that “it appears there are no other contemporaneous medical records
in existence that would potentially support petitioner’s description of post-vaccination
symptoms.” (Id.) Moreover, “[t]he language of Dr. Backes’s letter strongly suggests
that C.R.’s 8/3/2018 and 9/19/2028 pediatric visits were not concerning for
encephalopathy.” (Id. at 2-3.)
The missing records were subsequently filed on August 10, 2022. (ECF No. 22;
Ex. 18.) Thereafter, I issued an order on August 11, 2022, explaining that
[b]ased on my review of the relevant records (Ex. 18, pp. 48-51), my initial
interpretation of Dr. Backes’s letter appears to have been correct with
respect to the 8/3/2018 and 9/18/2018 encounters. Additionally, although
Dr. Backes’s letter indicates he received a later parental report concerning
for encephalopathy at the 10/26/2018 encounter, this is not reflected in the
resulting medical record. (Ex. 18, p. 47.) Dr. Backes added a diagnosis of
Autism spectrum disorder to his assessment as of December 27, 2018. (Id.
at 43.) He added “[a]dverse effect of vaccine, initial encounter” to his
assessment as of January 3, 2019. (Id. at 42.)
(ECF No. 23, p. 1.) I ordered respondent to file his Rule 4(c) Report in 60 days if
petitioner did not voluntarily dismiss the case in the interim. (Id. at 2.)
2
Respondent filed a combined Rule 4(c) Report and Motion to Dismiss on October
7, 2022. (ECF No. 24.) Respondent’s report includes a complete recitation of C.R.’s
medical records and explains the government’s position. The government argues that
Dr. Backes’s diagnosis stands alone against the weight of evidence and is not credible.
The government argues that this case neither meets the Vaccine Injury Table definition
of encephalopathy nor satisfies the standards for finding vaccine causation-in-fact. The
government stresses that “[a]t bottom, this is an autism case that is indistinguishable
from past autism cases, which the special masters have uniformly dismissed.” (Id. at
11.)
After the filing of the respondent’s report, I issued an order requiring petitioner to
show cause by no later than December 7, 2022, why this case should not be dismissed.
(ECF No. 25.) After explaining the background of the case and the petitioner’s burden
of proof, I instructed petitioner to file a brief both responding to respondent’s motion to
dismiss and explaining pursuant to Vaccine Rule 8(d) why petitioner believes she is
entitled to compensation on the existing record. (Id. at 3.) Alternatively, I permitted
petitioner the opportunity to explain why further proceedings are reasonably necessary
to develop the record and to provide an offer of proof that a credible expert report is
possible. (Id.) I further explained that
Petitioner’s show cause response shall not be limited to a response to
respondent’s motion to dismiss. Even if I conclude that the petition should
not be summarily dismissed as a matter of law under the standards of RCFC
12(b)(6), given that complete medical records have been filed I intend to
further determine based on petitioner’s show cause response whether this
case is appropriate for resolution under the preponderant evidence
standard based on the existing record.
(Id.)
Petitioner filed no response to the show cause order. Subsequently, on
December 22, 2022, I issued an order noting for the record petitioner’s failure to
respond to the prior order to show cause and explaining that “[p]etitioner is hereby put
on notice that the undersigned will issue a decision resolving this case on the existing
record pursuant to Vaccine Rule 8(d).” (ECF No. 26.) I advised that if petitioner takes
no action, that decision will issue on Monday, January 23, 2023. (Id.)
However, on January 17, 2023, petitioner filed a motion for extension of time.
(ECF No. 27.) Petitioner requested 30 days “to supplement the record with additional
supporting evidence (if possible) and respond to Respondent’s Motion to Dismiss.” (Id.
at 1.) Petitioner’s motion was granted, giving petitioner until February 17, 2023, to file a
response to the order to show cause. (Order (Non-PDF), 1/17/2023.) In granting the
motion I reiterated that petitioner shall file a response to my order to show cause that is
not limited to responding to respondent’s motion to dismiss. (Id.)
3
On February 17, 2023, petitioner filed a second motion for extension of time.
(ECF No. 28.) This time petitioner requested additional time until March 10, 2023, to file
a report by Dr. Shawn Aylward, C.R.’s treating neurologist. (Id.) Petitioner indicated
that she had attempted to contact Dr. Aylward for clarification regarding the notation in
his medical record that “I cannot conclusively blame this on his immunization.” (Id.
(referring to Ex. 9, p. 350).) Petitioner was reportedly informed, however, that Dr.
Aylward was out of the country. Nothing in petitioner’s motion suggests that petitioner
actually made contact with Dr. Aylward or that he was willing to offer a report in this
case. Petitioner’s motion was granted, but no additional filings were made.
II. Factual History
C.R. was born on March 15, 2017, full term and without complication. (Ex. 11, p.
13.) He was generally healthy with no growth or development concerns noted during
his first 15 months. On June 18, 2018, he presented for his 15-month well child
encounter. (Ex. 18, p. 557.) His development was normal and he was administered the
vaccines at issue in this case. (Id.; see also Ex. 1, p. 1; Ex. 5, p. 2.) According to
petitioner’s affidavit, C.R. began experiencing new onset of the following symptoms
“shortly after” receipt of these vaccines: lethargy, dizziness and diarrhea, loss of
appetite, uncontrollable crying, red and swollen injection site, tremors and body jerking,
head shaking and wobbly gait, catatonic – staring off into space, and speech
deterioration. (Ex. 2, p. 1.)
C.R. was next seen for medical care at his pediatrician’s office on August 3,
2018, about six weeks post-vaccination. (Ex. 18, p. 51.) At that time he was seen by
Dr. Backes for an ear infection. The symptoms described in petitioner’s affidavit are not
noted. No concern is noted regarding either encephalopathy or developmental concern.
No mention is made of any vaccine reaction.
C.R.’s next medical encounter was his 18-month well child exam on September
18, 2018. (Ex. 18, pp. 452-53.) At this encounter, he saw Dr. Spitler. The interval
history indicates that C.R. had no interim illnesses and that his parents had no
questions or concerns. (Id.) Again, the symptoms listed in petitioner’s affidavit were not
noted and no concern for any encephalopathy was noted. Because this was a well child
exam, a developmental assessment was conducted. C.R. was noted to have speech
delay and a sensory food aversion. (Id.) Dr. Spitler referred C.R. for speech and
occupational therapy and recommended that petitioner monitor C.R. closely for the next
six months because “he is exhibiting some signs of autism.” (Id. at 453.) C.R. was
administered a Hepatitis A vaccination. (Id. at 454; Ex. 1.)
On October 2, 2018, C.R. had an occupational therapy oral motor evaluation.
(Ex. 9, p. 86.) C.R. presented with “no significant medical history.” (Id.) His prior
developmental history was characterized as “[o]n target except for gross motor skills.
He started off advanced with speech, then went backwards.” (Id. at 88.) His primary
encounter diagnosis was “feeding difficulties.” (Id. at 86.) C.R. had a speech/language
evaluation six days later on October 8, 2018. (Id. at 106.) Petitioner provided a
4
complete developmental history that included no description of any acute post-
vaccination process or resembling an acute encephalopathy. Rather, petitioner
specifically indicated that C.R. has an older brother with autism and that she is
concerned he is developing similar symptoms. (Id. at 106-07.) C.R. was assessed as
having delayed receptive and expressive language skills. (Id. at 107.)
C.R. returned to Dr. Backes on October 26, 2018. (Ex. 18, pp. 47, 478.) 3 Under
chief complaint, C.R. was noted to be “still ill” (Ex. 18, p. 47) with symptoms of an upper
respiratory infection, cough, and low-grade fever (Id. at 478). C.R. was assessed with a
primary diagnosis of croup along with abnormal gait, speech delay, and a failed
screening test. (Id. at 47.) The computer-generated progress note indicates C.R.
developed speech delay and food texture issues in the Fall of 2018. (Id.) The
handwritten notes additionally indicate that C.R. developed his gait abnormality “post
Hep A” 4 and a developmental regression of unspecified onset. (Id. at 478.) There is no
notation of any suspicion of a post-vaccination encephalopathy.
On November 6, 2018, C.R. was evaluated for autism and was assessed as
having autism spectrum disorder (“ASD”). (Ex. 10, p. 3.) C.R.’s parents described
onset of motor and speech regression at around 15 months of age. (Id.) Further follow
up was recommended and he had a psychological evaluation on December 21, 2018.
(Id. at 21-30.) The provided history indicates in pertinent part:
[C.R.] appears to have unusual reactions following vaccines, including
significant regression in development. [C.R.]’s speech had been developing
but at about 15 months he received a vaccine and he stopped talking. He
was beginning to walk appropriately, but after receiving a vaccine in
September 2018, he started stumbling and his gross motor skills continue
to be delayed. His mother reported that [C.R.] “acts like his right leg is
paralyzed” and that his bones also “crack” often.
(Id. at 23.) Based on application of the Autism Diagnostic Observation Schedule,
Second Edition, there was a moderate-to-severe concern that C.R. has ASD. (Id. at
29.)
C.R. returned to Dr. Backes on December 27, 2018, with a chief complaint of
“F/u,” i.e. “follow up.” (Ex. 18, p. 43.) The handwritten notes for the encounter indicate
a chief complaint of “limping, legs abnormal” and note onset to have been after his
3
Two separate records exist from Kiddie West Pediatrics for C.R.’s October 26, 2018 encounter. At page
47 of Exhibit 18, a computer-generated progress note is electronically signed by Dr. Backes. At page 478
of Exhibit 18, a handwritten progress note appears to contain additional description of the same
encounter. The same format holds for his later December 27, 2018 and January 3, 2019 encounters
discussed below. (Compare Ex. 18, p. 42-43 and, Ex. 18, p. 498-99.)
4
C.R. had Hepatis A vaccines administered September 18, 2018, and March 15, 2018. (Ex. 1.) Neither
the petition filed in this case nor petitioner’s affidavit include any allegation regarding adverse effects of
C.R.’s Hepatitis A vaccinations. (ECF No. 1; Ex. 2.)
5
September 18, 2018 vaccination. (Ex. 18, p. 498.) The assessment was abnormal gait,
developmental regression, carotenemia, and ASD. (Ex. 18, pp. 43, 498.)
C.R. again returned to Dr. Backes on January 3, 2019. The chief complaint was
“discuss issue with doctor.” (Ex. 18, p. 42.) Dr. Backes added “adverse effect of
vaccine, initial encounter” to his assessment. (Id.) This time, Dr. Backes’s handwritten
notes indicate C.R.’s June 18, 2018 DTaP and Hib vaccines as causally relevant along
with C.R.’s later September 18, 2018 Hepatitis A vaccine. (Id. at 499.) Genetic testing
was subsequently conducted but was negative. (Ex. 9, pp. 174-77; Ex. 18, pp. 425,
433.)
C.R. was seen by a neurologist on March 12, 2019. (Ex. 9, pp. 348-50.) This
time, his parents reported that the “[i]ssues all started after his last vaccine (9/18/18),
which is also when mother reports he had loss of the two words he had (mamma,
dadda) and social regression.” (Id. at 348.) The neurologist opined that “[t]he workup
done so far has ruled out a structural brain or peripheral nerve cause for his issues. I
cannot conclusively blame this on his immunization. At this time, I would recommend
they give therapy a little more time.” (Id. at 350.)
On March 28, 2019, Dr. Backes wrote a note on a prescription pad that “[C.R.]
had a [reaction] to a DTAP on 6/18/18. Within 24 hours reactions began
encephalopathic.” (Ex. 5, p. 1.) On January 14, 2020, Dr. Backes also wrote a “To
Whom it May Concern” letter in support of petitioner’s Vaccine Act claim. (Ex. 7.) In his
letter, Dr. Backes writes that following C.R.’s June 18, 2018 vaccinations:
[a]lmost immediately he was lethargic, febrile, and ‘not himself’ per mother.
He progressed within 24 hours to shaking his head like he was dizzy and
had diarrhea and loss of appetite. His DTAP injection site was red and
swollen (hard) per observation of mother. Per mother over the next 48 hours
his neuro status worsened – uncontrollable crying, starting off into space,
head shaking, and stopped talking, stared into space and he began
stumbling while walking all per mothers’ observation.
(Ex. 7, p. 1.)
Dr. Backes further relates that on October 26, 2018, he “had the pleasure of a
face to face exam and discussed the parental concerns of [C.R.]; I then referred [C.R.] .
. . for evaluation of developmental regression and to orthopedics for his abnormal gait.”
(Ex. 7, p. 1.) He confirms that subsequent MRI and EMG studies were negative and
that as of February 27, 2019, C.R.’s diagnosis was ASD with ongoing speech, physical,
and occupational therapies. (Id.)
In summary, Dr. Backes writes:
Per mother [C.R.’s] rection to the DTAP began 4 hours after the second
injection and his encephalopathy signs occurred less than 72 hours post
6
DTAP injection. Because of this time sequence with parental observation
and the ongoing post neurological changes I am writing on his behalf to file
for the Vaccine Injury Compensation Program. I am doing this now as a
claim within 36-months of age with no signs of recovery from his second
DTAP vaccine reaction. No VAERS was completed as this was originally
done by parental observation only and concerns were not brought to my
attention until 10/26/2018.
(Ex. 7, p. 2.)
III. Applicable Statutory Scheme
Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination also specified in the Table. If so, the
Table Injury is presumed to have been caused by the vaccination, and the petitioner is
automatically entitled to compensation, unless it is affirmatively shown that the injury
was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300 aa-
11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
As relevant here, “encephalopathy” is listed on the Vaccine Injury Table relative
to pertussis-containing vaccines if it occurs within 72 hours of vaccination. 42 C.F.R.
§ 100.3(a)(II). Table Injury cases are guided by statutory “Qualifications and Aids in
interpretation” (“QAIs”), which provide more detailed explanation of what should be
considered when determining whether a petitioner has actually suffered an injury listed
on the Vaccine Injury Table. 42 CFR § 100.3(c). 5 In order to be considered a “Table”
encephalopathy, the condition at issue must include an “acute encephalopathy”
occurring within the prescribed Table window and as defined by the QAI and be
followed by a “chronic encephalopathy” separately defined by the QAI. 42 CFR
§ 100.3(c)(2).
5
The Vaccine Injury Table and QAI at 42 C.F.R. § 100.3 was most recently updated on January 3, 2022.
The version of the Table that governs this case is the prior version that was in effect from March 21,
2017, to January 2, 2022. §300aa-14(c)(4) (explaining that modifications to the Vaccine Injury Table
“shall apply only with respect to petitioners for compensation under the Program which are filed after the
effective date of such regulation).
7
For children less than 18 months of age, an acute encephalopathy is indicated by
“a significantly decreased level of consciousness that lasts at least 24 hours.” Id. Per
the QAI, the following do not in themselves demonstrate an acute encephalopathy:
sleepiness, irritability or fussiness, high-pitched or unusual screaming, poor feeding,
persistent inconsolable crying, bulging fontanelle, or symptoms of dementia. Id.
Seizures are also inadequate to demonstrate an acute encephalopathy. Id. Under the
QAI, underlying conditions or systemic diseases are exclusionary criteria that prevent
an encephalopathy from being considered a Table Injury. Id. In general, a “chronic
encephalopathy” is demonstrated where the change in mental state constituting an
acute encephalopathy persists for at least six months. Where an individual returns to
their baseline neurologic state prior to six months, any subsequent encephalopathy will
not be presumed to be sequela of the acute encephalopathy. Id.
Alternatively, if no injury falling within the Table can be shown, the petitioner may
still demonstrate entitlement to an award by showing that the vaccine recipient’s injury
or death was caused-in-fact by the vaccination in question. § 300aa-13(a)(1)(A);
§ 300aa-11(c)(1)(C)(ii). To so demonstrate, a petitioner must show that the vaccine
was “not only [the] but-for cause of the injury but also a substantial factor in bringing
about the injury.” Moberly ex rel. Moberly v. Sec'y of Health & Human Servs., 592 F.3d
1315, 1322 n.2 (Fed. Cir. 2010) (quoting Shyface v. Sec'y of Health & Human Servs.,
165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of Health & Human Servs.,
451 F.3d 1352, 1355 (Fed. Cir. 2006). In particular, a petitioner must show by
preponderant evidence: (1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and (3) a showing of proximate temporal relationship between
vaccination and injury in order to prove causation-in-fact. Althen v. Sec’y of Health &
Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
For both Table and Non–Table claims, Vaccine Program petitioners must
establish their claim by a “preponderance of the evidence”. § 300aa-13(a). That is, a
petitioner must present evidence sufficient to show “that the existence of a fact is more
probable than its nonexistence . . . .” Moberly, 592 F.3d at 1322 n.2. Proof of medical
certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873
(Fed. Cir. 1991). However, a petitioner may not receive a Vaccine Program award
based solely on her assertions; rather, the petition must be supported by either medical
records or by the opinion of a competent physician. § 300aa-13(a)(1). Once a
petitioner has established their prima facie case, the burden then shifts to respondent to
prove, also by preponderant evidence, that the alleged injury was caused by a factor
unrelated to vaccination. Althen, 418 F.3d at 1278 (citations omitted); § 300aa-
13(a)(1)(B).
IV. Legal Standard for Fact Finding
A special master must consider the record as a whole, but is not bound by any
diagnosis, conclusion, judgment, test result, report, or summary concerning the nature,
causation, and aggravation of petitioner’s injury or illness that is contained in a medical
record. §300aa-13(b)(1). However, the Federal Circuit has held that contemporaneous
8
medical records are ordinarily to be given significant weight due to the fact that “[t]he
records contain information supplied to or by health professionals to facilitate diagnosis
and treatment of medical conditions. With proper treatment hanging in the balance,
accuracy has an extra premium. These records are also generally contemporaneous to
the medical events.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528
(Fed. Cir. 1993).
Thus, where medical records are clear, consistent, and complete, they should be
afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V,
2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule is
not absolute. Afterall, “[m]edical records are only as accurate as the person providing
the information.” Parcells v. Sec’y of Health & Human Servs., No. 03-1192V, 2006 WL
2252749, at *2 (Fed. Cl. Spec. Mstr. July 18, 2006). In Lowrie, the special master wrote
that “written records which are, themselves, inconsistent, should be accorded less
deference than those which are internally consistent.” 2005 WL 6117475, at *19
(quoting Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d
per curiam, 968 F.2d 1226 (Fed. Cir. 1992)). Importantly, however, “the absence of a
reference to a condition or circumstance is much less significant than a reference which
negates the existence of the condition or circumstance.” Murphy, 23 Cl. Ct. at 733(quoting the decision below), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992).
When witness testimony is offered to overcome the weight afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent,
and compelling.” Camery v. Sec'y of Health & Human Servs., 42 Fed. Cl. 381, 391
(1998) (citing Blutstein v. Sec'y of Health & Human Servs., No. 90–2808V, 1998 WL
408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). Further, the Special Master must
consider the credibility of the individual offering the testimony. Andreu v. Sec’y of
Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of
Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). In determining whether
to afford greater weight to contemporaneous medical records or other evidence, such
as testimony, there must be evidence that this decision was the result of a rational
determination. Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir.
1993). The special master is obligated to consider and compare the medical records,
testimony, and all other “relevant and reliable evidence contained in the record.” La
Londe v. Sec'y Health & Human Servs., 110 Fed. Cl. 184, 204 (2013) (citing § 12(d)(3);
Vaccine Rule 8), aff'd, 746 F.3d 1334 (Fed. Cir. 2014); see also Burns, 3 F.3d at 417.
V. Discussion
a. It is appropriate to resolve this case on the existing record
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. §300aa-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 & Human Servs., 945 F.3d 1362,
9
1366 (Fed. Cir. 2020); see also Hooker v. Sec’y of Health & Human 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 do note, however, that in all events special masters must afford each party “a
full and fair opportunity to present its case and create a record sufficient to allow review
of the special master’s decision.” Vaccine Rule 3(b)(2). In this case, respondent has
set forth his position in his Rule 4 Report and also included a motion to dismiss within
his report. (ECF No. 24.) I subsequently issued an order to show cause providing
petitioner an opportunity not only to respond to respondent’s motion to dismiss, but also
to present a legal brief in support of entitlement pursuant to Vaccine Rule 8(d).
Moreover, I explicitly permitted petitioner to present an argument and offer of proof
regarding the need for further development of the record. Following two motions for
extension of time, petitioner ultimately filed no response and offered no basis upon
which to conclude that any credible expert report is feasible or that further development
of the record is reasonably necessary.
Accordingly, I conclude that the parties have had a full and fair opportunity to
develop the record and further that resolution of this case on the existing record
pursuant to Vaccine Rule 8(d) is appropriate. It is therefore not necessary to separately
resolve whether respondent would otherwise be entitled to the relief under the
standards applicable to his motion to dismiss.
b. Table encephalopathy
i. Acute encephalopathy
In order to establish a Table encephalopathy, petitioner must first establish that,
within 72 hours of vaccination, C.R. experienced onset of an acute encephalopathy,
which is “a significantly decreased level of consciousness that lasts at least 24 hours.”
42 CFR § 100.3(c)(2). Per the QAI, the following do not in and of themselves
demonstrate an acute encephalopathy: sleepiness, irritability or fussiness, high-pitched
or unusual screaming, poor feeding, persistent inconsolable crying, bulging fontanelle,
or symptoms of dementia. Rather, “[t]he symptoms associated with an acute
encephalopathy are neither subtle nor insidious.” Blake v. Sec'y of Health & Human
Servs., No. 03-31V, 2014 WL 2769979, at *6 (Fed. Cl. Spec. Mstr. May 21, 2014)
(quoting Waddell v. Sec'y of Health & Human Servs., No. 10-316V, 2012 WL 4829291,
at *6 (Fed. Cl. Spec. Mstr. Sept. 19, 2012)). Acute and chronic encephalopathy is a
serious injury that can necessitate hospitalization. Miller v. Sec'y of Health & Human
Servs., No. 02-235V, 2015 WL 5456093, at *37 (Fed. Cl. Spec. Mstr. Aug. 18, 2015).
In this case, petitioner’s affidavit asserts the following symptoms occurred within
24 hours of vaccination: lethargy, dizziness and diarrhea, loss of appetite,
uncontrollable crying, red and swollen injection site, tremors and body jerking, head
shaking and wobbly gait, catatonic – staring off into space, and speech deterioration.
10
(Ex. 2, p. 1.) However, this description is not supported by the medical records as
delineated above. Considered as a whole, C.R.’s medical records from June of 2018
through March of 2019 reflect an evolving pattern of developmental concerns with
uncertain dates of onset for specific clinical features. When comparing petitioner’s
affidavit with the many histories she provided to C.R.’s treating physicians, there is not
preponderant evidence that C.R. experienced an acute encephalopathy within 72 hours
of his pertussis-containing vaccination. To the extent petitioner’s affidavit describes an
abrupt onset of numerous symptoms she now asserts are concerning for an acute
encephalopathy, there is no explanation to indicate why these symptoms were not the
subject of prompt medical attention, why C.R. was not seen by any physician for any
reason between June 18, 2018, and August 3, 2018, or why these specific symptoms
were not explicitly reported at numerous subsequent medical encounters.
ii. Chronic encephalopathy
Even if petitioner had hypothetically demonstrated an acute encephalopathy, she
must also demonstrate the presence of a chronic encephalopathy in order to present a
Table claim. A “chronic encephalopathy” is demonstrated where the change in mental
state constituting an acute encephalopathy persists for at least six months. Where an
individual returns to a baseline neurologic state prior to six months, any subsequent
encephalopathy will not be presumed to be sequela of the acute encephalopathy.
§ 100.3(d)(1)(ii).
Here, C.R. was seen at six separate medical encounters during the six months
following the vaccinations at issue, including encounters with two separate
pediatricians, speech and language therapy evaluations, and a psychological
evaluation. None of the medical professionals he saw during this period recorded any
suspicion for an encephalopathic state. Although Dr. Backes later endorsed a post-
vaccination encephalopathy, he stressed that this was based on parental report only.
(Ex. 7, p. 2.) Thus, Dr. Backes confirms that he did not observe C.R. to be
encephalopathic during his encounters of August 3, 2018 and October 26, 2018, a point
also reflected by his contemporaneous medical records. (Id.; Ex. 18, pp. 47, 51, 478.)
Additionally, Dr. Backes’s office colleague, Dr. Spitler, saw C.R. on September 18,
2018. (Ex. 18, pp. 452-53.) At that time, Dr. Spitler conducted a complete 18-month
well exam, including developmental screening, and found no concern regarding any
possible encephalopathy or altered mental state. These exams preponderantly
demonstrate that, even if C.R. had experienced the post-vaccination symptoms alleged,
he was back to his neurologic baseline by the time he began returning to medical care
the following month, albeit the baseline of a child with developmental concerns
consistent with emerging ASD. Thus, there is not preponderant evidence of a chronic
encephalopathy.
c. Encephalopathy caused-in-fact by vaccination
Petitioner also has not demonstrated that C.R. suffered an encephalopathy
caused-in-fact by his vaccinations. Again, although Dr. Backes endorsed a parental
11
report of a post-vaccination encephalopathy, the fact that he relies on parental report
alone confirms that he did not observe any encephalopathic symptoms during his
contemporaneous medical encounters with C.R. Nor, for that matter, did he record a
diagnosis of encephalopathy in any of his actual medical treatment records. (Ex. 18.)
Moreover, the fact that Dr. Backes specifies that his letter is specifically for
compensation purposes and that he declined to submit a VAERS report strongly
suggests that his opinion is not stated to a sufficient degree of certainty. 6 Boatmon v.
Sec'y of Health & Human Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (explaining that
“[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.”). Nor does Dr. Backes provide any explanation of the basis for his causal
assessment. Also of note, Dr. Backes is C.R.’s pediatrician. C.R.’s neurologist, by
contrast, expressed doubt that his condition was vaccine related despite also receiving
a parental report of symptoms beginning post-vaccination. (Ex. 9, p. 350.)
d. Autism
A petitioner may not receive a Vaccine Program award based solely on her
assertions; rather, the petition must be supported by either medical records or by the
opinion of a competent physician. § 300aa-13(a)(1). Here, petitioner appears to have
included in her petition an allegation that C.R. suffered vaccine-caused ASD. (ECF No.
1, p. 3.) However, neither C.R.’s medical records nor Dr. Backes’s letter supporting
petitioner’s claim includes any suggestion that C.R.’s autism was caused by his
vaccinations. Nor would such an opinion be credible if it were offered.
The question of vaccine-caused ASD has been extensively litigated both in the
original Omnibus Autism Proceeding (“OAP”) test cases 7 as well as in numerous
6
VAERS is a passive reporting system where “[anyone can report an adverse event” following
vaccination. About VAERS, HHS.GOV, https://vaers.hhs.gov/about.html (last accessed Dec. 21, 2022). It
is “not designed to determine if a vaccine caused a health problems, but is [] useful for detecting unusual
or expected patterns of adverse event reporting that might indicate a possible safety problem with a
vaccine. Id.; see Bender v. Sec’y of Health & Human Servs., No. 11-693V, 2018 WL 3679637, at *31
(Fed. Cl. Spec. Mstr. July 2, 2018) (“[b]ecause it is a passive reporting system, VAERS database findings
… cannot be reasonably interpreted to suggest causation. For this reason, special masters do not
typically afford great weight to VAERS data in determining causation”) (citing Analla v. Sec'y of Health &
Human Servs., 70 Fed. Cl. 552, 558 (2006) (“the Court [of Federal Claims] uniformly has upheld the Chief
Special Master's concerns about the reliability of VAERS data”)). The fact that Dr. Backes specifies that
the parental report he received regarding C.R.’s possible post-vaccination encephalopathy did not rise to
a level of suspicion he felt would support a VAERS submission is very telling, especially given that
VAERS itself disclaims any definitive causal assessment.
7
See Cedillo v. Sec’y of Health & Human Servs., No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr.
Feb. 12, 2009) aff'd, 89 Fed. Cl. 158 (2009), aff'd, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y of
Health & Human Servs., No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff'd 88
Fed. Cl. 473 (2009), aff'd, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y of Health & Human Servs., No.
01-162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff'd, 88 Fed. Cl. 706 (2009); Dwyer v.
Sec’y of Health & Human Servs., No. 03-1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010);
King v. Sec’y of Health & Human Servs., No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12,
12
subsequent individual cases pursuing separate theories of causation. 8 These cases
have invariably been dismissed for failing to preponderantly establish a prima facie
showing of causation. Although a child who happens to have ASD can still suffer a
separate vaccine-related injury, 9 that is not the case here for all the reasons discussed
above.
2010); Mead v. Sec’y of Health & Human Servs., No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr.
Mar. 12, 2010).
8
See, e.g., Henderson v. Sec’y of Health & Human Servs., No. 09-616V, 2012 WL 5194060 (Fed. Cl.
Spec. Mstr. Sept. 28, 2012) (autism not caused by pneumococcal vaccination); Franklin v. Sec’y of Health
& Human Servs., No. 99-855V, 2013 WL 3755954 (Fed. Cl. Spec. Mstr. May 16, 2013) (MMR and other
vaccines found not to contribute to autism); Coombs v. Sec’y of Health & Human Servs., No. 08-818V,
2014 WL 1677584 (Fed. Cl. Spec. Mstr. Apr. 8, 2014) (autism not caused by MMR or Varivax vaccines);
Blake v. Sec’y of Health & Human Servs., No. 03-31V, 2014 WL 2769979 (Fed. Cl. Spec. Mstr. May 21,
2014) (autism not caused by MMR vaccination); Long v. Sec’y of Health & Human Servs., No. 08-792V,
2015 WL 1011740 (Fed. Cl. Spec. Mstr. Feb. 9, 2015) (autism not caused by influenza vaccine); Brook v.
Sec’y of Health & Human Servs., No. 04-405V, 2015 WL 3799646 (Fed. Cl. Spec. Mstr. May 14, 2015)
(autism not caused by MMR or Varivax vaccines); Holt v. Sec’y of Health & Human Servs., No. 05-136V,
2015 WL 4381588 (Fed. Cl. Spec. Mstr. June 24, 2015) (autism not caused by hepatitis B vaccine);
Lehner v. Sec’y of Health & Human Servs., No. 08-554V, 2015 WL 5443461 (Fed. Cl. Spec. Mstr. July
22, 2015) (autism not caused by influenza vaccine); Miller v. Sec’y of Health & Human Servs., No. 02-
235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. Aug. 18, 2015) (ASD not caused by combination of
vaccines); Allen v Sec’y of Health & Human Servs., No. 02-1237V, 2015 WL 6160215 (Fed. Cl. Spec.
Mstr. Sept. 26, 2015) (autism not caused by MMR vaccination); R.K. v. Sec’y of Health & Human Servs.,
No. 03-632V, 2015 WL 10936124 (Fed. Cl. Spec. Mstr. Sept. 28, 2015) (autism not caused by influenza
vaccine), aff'd, 125 Fed. Cl. 57 (2016); Hardy v. Sec’y of Health & Human Servs., No. 08-108V, 2015 WL
7732603 (Fed. Cl. Spec. Mstr. Nov. 3, 2015) (autism not caused by several vaccines); Sturdivant v. Sec’y
of Health & Human Servs., No. 07-788V, 2016 WL 552529 (Fed. Cl. Spec. Mstr. Jan. 21, 2016) (autism
not caused by Hib and Prevnar vaccines); R.V. v. Sec’y of Health & Human Servs., No. 08-504V, 2016
WL 3882519 (Fed. Cl. Spec. Mstr. Feb. 19, 2016) (autism not caused by influenza vaccine) (on Court
website), aff'd, 2016 WL 3647786 (Fed. Cl. June 2, 2016); Murphy v. Sec’y of Health & Human Servs.,
No. 05-1063V, 2016 WL 3034047 (Fed. Cl. Spec. Mstr. Apr. 25, 2016) (autism not caused by DTaP or
MMR vaccines), aff’d, 128 Fed. Cl. 348 (2016); Waddell v. Sec’y of Health & Human Servs., No. 10-316V,
2012 WL 4829291 (Fed. Cl. Spec. Mstr. Sept. 19, 2012) (autism not caused by MMR vaccination); Fester
v. Sec’y of Health & Human Servs., No. 10-243V, 2016 WL 1745436 (Fed. Cl. Spec. Mstr. Apr. 7, 2016)
(autism not caused by measles, mumps, rubella, and varicella (MMRV) vaccine); Fresco v. Sec’y of
Health & Human Servs., No. 06-469V, 2013 WL 364723 (Fed. Cl. Spec. Mstr. Jan. 7, 2013) (autism not
caused by multiple vaccines); Fesanco v. Sec’y of Health & Human Servs., No. 02-1770, 2010 WL
4955721 (Fed. Cl. Spec. Mstr. Nov. 9, 2010) (autism not caused by multiple vaccines); Miller v. Sec’y of
Health & Human Servs., No. 06-753V, 2012 WL 12507077 (Fed. Cl. Spec. Mstr. Sept. 25, 2012) (autism
not caused by DTaP or MMR vaccines); Pietrucha v. Sec’y of Health & Human Servs., No. 00-269V, 2014
WL 4538058 (Fed. Cl. Spec. Mstr. Aug. 22, 2014) (autism not caused by multiple vaccines); Bushnell v.
Sec’y of Health & Human Servs., No. 02-1648, 2015 WL 4099824 (Fed. Cl. Spec. Mstr. June 12, 2015)
(autism not caused by multiple vaccines); Bokmuller v. Sec’y of Health & Human Servs., No. 08-573,
2015 WL 4467162 (Fed. Cl. Spec. Mstr. June 26, 2015) (autism not caused by multiple vaccines); Canuto
v. Sec’y of Health & Human Servs., No. 04-1128, 2015 WL 9854939 (Fed. Cl. Spec. Mstr. Dec. 18, 2015)
(autism not caused by DTP and DTaP vaccines); Valle v. Sec’y of Health & Human Servs., No. 02-220V,
2016 WL 2604782 (Fed. Cl. Spec. Mstr. Apr. 13, 2016) (autism not caused by DTaP vaccine). Judges of
this court have affirmed the practice of dismissal without trial in such cases. E.g., Fesanco v. Sec’y of
Health & Human Servs., 99 Fed. Cl. 28 (2011) (Judge Braden affirming); Canuto v. Sec’y of Health &
Human Servs., No. 04-1128V, 2016 WL 2586510 (Judge Yock affirming).
9
See Wright v. Sec’y of Health & Human Servs., No. 12-423, 2015 WL 6665600 (Fed. Cl. Spec. Mstr.
Sept. 21, 2015). Special Master Vowell concluded that a child, later diagnosed with ASD, suffered a
13
VI. Conclusion
Considering the record as a whole under the standards applicable in this
Program, petitioner has not preponderantly established that C.R.’s June 18, 2018
vaccinations caused an encephalopathy or his ASD. Accordingly, petitioner is not
entitled to compensation. Therefore, this case is dismissed. 10
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
“Table Injury” after a vaccination. However, she stressed that she was not finding that the vaccinee's
ASD in that case was “caused-in-fact” by the vaccination—to the contrary, she specifically found that the
evidence in that case did not support a “causation-in-fact” claim, going so far as to remark that the
petitioners' “causation-in-fact” theory in that case was “absurd.” Id. at *2.
10
In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter
judgment accordingly.
14