N. v. Secretary of Health and Human Services

REISSUED FOR PUBLICATION
JULY 18, 2019
OSM
U.S. COURT OF FEDERAL CLAIMS
Jfn tbc Wnitcb $1atcs Qtourt of jfcbcral Qtlaims
No. 17-1418V
Filed: July 3, 2019
Reissued for Publication: July 18, 2019 1
* * * * * * * * * * * * * * * * * **
*
KEITH NOE and CAROL LANGLEY, *
o/b/o J.J.N., a minor, *
Petitioners, * Vaccine Act; DTaP and MMR
*
Vaccinations; Table Claim;
v. *
Non-Table Claim; Acute
SECRETARY OF HEAL TH
* Encephalopathy; Autism.
*
AND HUMAN SERVICES, *
Respondent. *
*
* ******************
Keith Noe and Carol Langley, pro se, Brockton, MA.
Lara A. Englund, Trial Attorney, Torts Branch, Civil Division, United States
Department of Justice, Washington, D.C., for Respondent. With her were Heather L.
Pearlman, Assistant Director, Torts Branch, Civil Division, Catharine E. Reeves, Deputy
Director, Torts Branch, Civil Division, C. Salvatore D' Alessio, Acting Director, Torts
Branch, Civil Division, and Joseph H. Hunt, Assistant Attorney General, Civil Division.
OPINION
HORN, J.
On October 3, 2017, prose petitioners Keith Noe and Carol Langley, parents of,
and on behalf of, minor J.J.N., 2 filed a petition for compensation in the above-captioned
1 This Opinion was issued under seal on July 3, 2019. The parties did not propose any
redactions to the July 3, 2019 Opinion, and the court, therefore, issues the Opinion without
redactions for public distribution.
2 Petitioners filed a motion to redact in which they "request that all confidential and
personal information regarding our son [J.J.N.] and daughter LSN be redacted from being
posted or released publicly." In recognition of J.J.N.'s status as a minor, this court refers
to him as "J.J.N.'' The court notes that even though petitioners requested the redactions,
there are references to J.J.N. by his real name in petitioners' filings. In this Opinion, the
court has changed those quotations out of respect for J.J.N.'s minor status.
case, pursuant to the National Childhood Vaccine Injury Act of 1986 (Vaccine Act), 42
U.S.C. §§ 300aa-1 -34 (2012), asking for relief based on alleged injuries suffered by J.J.N.
Petitioners allege these injuries occurred because of vaccinations J.J.N. received on
September 24, 2014 and November 25, 2014. Petitioners subsequently filed an amended
petition on February 14, 2018. The case was originally assigned to Special Master
Thomas L. Gowen, but was transferred to Special Master Brian H. Corcoran of the United
States Court of Federal Claims on May 30, 2018. 3 On February 4, 2019, Special Master
Corcoran denied petitioners' request for compensation, finding that petitioners had
presented insufficient evidence to prove their claims. See K.N. v. Sec'y of Health &
Human Servs., No. 17-1418V, 2019 WL 1123016, at *2 (Fed. Cl. Spec. Mstr. Feb. 4,
2019). On February 13, 2019, the prose petitioners submitted a document titled "Notice
of Appeal," which, as discussed further below, the court treats as a timely motion for
review of Special Master Corcoran's decision. On March 7, 2019, petitioners filed a
memorandum of objection with this court, but also tried to add additional exhibits to the
record in support of their motion for review of the Special Master's decision denying
petitioners' claim, which had not been filed with the Special Master before he issued his
February 4, 2019 decision. 4
FINDINGS OF FACT
According to the records before the court, J.J.N. was born on June 19, 2013 at 39
weeks. In the petition for compensation, petitioners alleged that prior to the vaccinations
at issue in this case, J.J.N. was a "very active, happy, easy baby." Petitioners requested
at J.J.N.'s two-month physical examination on August 20, 2013 that J.J.N.'s vaccines be
staggered. At his nine-month well-baby exam on February 27, 2014, it was reported by
petitioners that J.J.N. occasionally had "hand flapping," although the examiner stated in
the medical report it seemed as if J.J.N. was just "hitting his thighs.'' Special Master
Corcoran found that this hand flapping was possibly one of "some vague preliminary
signs" of developmental problems, see K.N. v. Sec'y of Health & Human Servs., 2019 WL
1123016, at *2, but petitioners maintain the "hand flapping" was normal, or was at least
thought to be normal according to the care provider petitioners consulted on February 27,
2014.
At a sick visit on July 5, 2014, it was noted in the medical record that J.J.N. had a
rash the petitioners felt might be eczema. On September 24, 2014, J.J.N. received his
one-year, well-baby check-up at fifteen months of age and was given the first round of
vaccines, which included the inactivated polio virus, the pneumococcal conjugate,
haemophilus influenzae, and influenza vaccines. A vaccine "catch up" occurred at the
September 24, 2014 check-up because of J.J.N. being five months behind on
3 The Chief Special Master may reassign a case as necessary for the "efficient
administration of justice." Vaccine Rule 3(d) (2019).
4According to Vaccine Rule 23(a), "[t]o obtain review of the special master's decision, a
party must file a motion for review with the clerk [of the United States Court of Federal
Claims] within 30 days after the date the decision is filed." See Vaccine Rule 23(a) (2019).
2
vaccinations. This vaccine "catch up" consisted of the inactivated polio virus, the
pneumococcal conjugate, haemophilus influenzae, and influenza vaccines. On October
1, 2014, J.J.N.'s primary care physician saw him for an insect bite that petitioners contend
may have occurred on September 28, 2014. Other than removing a tick from his shoulder
blade the medical record noted that J.J.N. was "normal" in all aspects, including
temperament. Special Master Corcoran noted in his dismissal of petitioners' case that at
various sick visits that occurred on October 1, October 3, and November 3, 2014, J.J.N.'s
primary care provider included "no report of a reaction independent from the primary
reasons for seeking treatment," at any of these visits. See id.
On November 5, 2014, petitioners reported to their primary care physician that
J.J.N. was not sleeping or making eye contact, and was "extremely fussy, and irritable."
Petitioners expressed concern at the November 5, 2014 check up about "underlying
'serious illness' including Lyme, as well as concerns about autism and developmental
delay or regression." According to the medical record, on November 5, 2014, J.J.N.'s
blood test was negative for Lyme disease.
On November 13, 2014, J.J.N. had a pediatric visit at which it was brought up by
petitioners that J.J.N. may have been experiencing seizures and other developmental
difficulties such as "walking high up on his tip toes" and "eye flickering." At J.J.N.'s 18-
month well baby exam, on November 25, 2014, J.J.N. received the second round of
vaccines, which consisted of measles-mumps-rubella (MMR), varicella, diphtheria-
tetanus-acellular pertussis (DTaP) and another flu vaccine. At this same exam, on
November 25, 2014, petitioners repeated their concerns about J.J.N.'s seizures and
developmental difficulties such as "walking high up on his tip toes" and "eye flickering."
The medical record before this court indicates that the pediatrician at this check-up,
however, noted J.J.N. as having a "normal" temperament and being "alert" and "very
active."
On December 11, 2014, J.J.N. was referred by his pediatrician, Dr. Wilson, to
receive a neurologic evaluation in order to assess the developmental difficulties
mentioned previously. In his decision dismissing the case, Special Master Corcoran noted
that at this evaluation J.J.N.'s mother "made no mention of the vaccinations J.J.N. had
received in September or November as having any relationship in her understanding to
his symptoms, although she did mention the early October tick bite." !fl The nurse
practitioner at the neurologic examination referenced "two episodes of altered
consciousness" in J.J.N.'s history, one occurring in early October of 2014 when he "had
increased irritability" and "was lethargic.'' The nurse practitioner took note of this episode
as a "possible seizure.'' The second noted episode occurred on November 8, 2014, when
J.J.N. was found "on the floor face down with his head to the side" and "limp" after jumping
on a trampoline. According to medical records submitted by petitioners, J.J.N. was
"somewhat tired" throughout the next day after the November 8, 2014 episode. During
the neurologic evaluation on December 11, 2014, the nurse practitioner noted, "[w]e are
also suspicious that this is leading to a possible Autism diagnosis and we will carefully
monitor him over the next few months." An MRI performed on January 29, 2015, revealed
3
J.J.N. has a "highly unusual configuration of the corpus callosum," 5 but there was "[n]o
conclusive evidence for an underlying metabolic condition." On March 4, 2015, at a follow-
up neurological evaluation, a nurse practitioner deemed J.J.N.'s "global regression" of his
development "strongly suggestive" of "traits of an autism spectrum disorder." The nurse
practitioner recommended speech and physical therapy for J.J.N., and noted that his
"Fragile X testing" was negative. 6 Special Master Corcoran stated that the medical record
provided by petitioners after the March 4, 2015 follow-up neurological examination
"discloses Petitioners' consistent efforts to provide J.J.N. the care necessary to treat his
developmental problems, but largely do not impact analysis of the present claim, and
therefore are not further discussed." See K.N. v. Sec'y of Health & Human Servs., 2019
WL 1123016, at *3.
On October 3, 2017, petitioners filed their prose petition on behalf of J.J.N. for
compensation under the National Vaccine Injury Compensation Program pursuant to the
Vaccine Act. Petitioners allege that "[p]rior to the administration of his September 24 2014
vaccination petitioner was in good health and suffered no medical conditions." Petitioners
also allege that on November 5, 2014, J.J.N. experienced various non-Table7 injuries,
including "Fever and Behavioral change." (capitalization in original). It is also alleged that
5 The "corpus callosum" is defined as "an arched mass of white matter, found in the depths
of the longitudinal fissure, composed of three layers of fibers, the central layer consisting
primarily of transverse fibers connecting the cerebral hemispheres." Dorland's Illustrated
Medical Dictionary. 417 (32nd ed. 2012).
6Fragile X syndrome is defined as "an X-linked syndrome associated with a fragile site
on the X chromosome ... associated with mental retardation ... in most males and mild
mental retardation in many heterozygous females." Dorland's Illustrated Medical
Dictionary, 1830.
7 For Vaccine Program claims, a petitioner may allege a Table injury or a non-Table injury.
See generally 42 C.F.R. § 300aa-11(c) (2018). A Table injury is defined as a claim that
demonstrates "that the person who suffered such injury or who died," was the recipient of
"a vaccine set forth in the Vaccine Injury Table," and that the recipient "sustained, or had
significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine
Injury Table in association with the vaccine referred to in subparagraph (A) or died from
the administration of such vaccine." See 42 C.F.R. §§ 300aa-11(c)(1)(A), 300aa-
11 (c)(1)(C)(i). A non-Table injury is defined as a claim that is not included on the Vaccine
Injury Table and that demonstrates that a recipient of a vaccination:
[S]uffered the residual effects or complications of such illness, disability,
injury, or condition for more than 6 months after the administration of the
vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered
such illness, disability, injury, or condition from the vaccine which resulted
in inpatient hospitalization and surgical intervention.
42 C.F.R. § 300aa-11(c)(1)(D)(i)-(iii).
4
on "Nov 14 2014," J.J.N. "presented to Dr. Wilson after experiencing Seizure activitey
[sic], unresponsive episodes and mental status change." On February 14, 2018,
petitioners filed an amended petition. The only Table claim that petitioners allege in the
amended petition is that of an "acute encephalopathy," 8 which is a Table claim for the
MMR and DTaP vaccinations. Petitioners allege that J.J.N. experienced symptoms of an
acute encephalopathy after his November 25, 2014 vaccinations.
Petitioners also describe other non-Table claims of "adverse effects" to
vaccinations J.J.N. had received on September 24, 2014, which petitioners describe as
follows:
After receiving these vaccinations, the petitioner developed diarrhea,
drowsiness, lethargy, severe irritability, fever, tremors, loss of appetite,
symptoms of severe pain including high pitched scream and "writhing" in
pain alteration in mental status loss of consciousness behavioral changes,
vomiting, and seizure. Petitioner also requests compensation for injury
consistent with acute encephalopathy resulting from adverse effect of a set
of vaccines received on November 25, 2014 including MMR #1, Varicella
#1, Fluzone Quad State, and DTAP #5 After which he developed symptoms
of acute encephalopathy. These symptoms included period of lethargy,
severe irritability, behavioral changes he became inconsolable, and
incredibly difficult to comfort or soothe, screaming and crying, he developed
expressive aphasia.[9] [J.J.N.] experienced negative side effects after a
hepatitis A vaccine January 6, 2018.
8 An encephalopathy is defined as "any degenerative disease of the brain." Dorland's
Illustrated Medical Dictionary, 614. The Vaccine Act explains that common symptoms are:
[F]ocal and diffuse neurologic signs, increased intracranial pressure, or
changes lasting at least 6 hours in level of consciousness, with or without
convulsions. The neurological signs and symptoms of encephalopathy may
be temporary with complete recovery, or may result in various degrees of
permanent impairment. Signs and symptoms such as high pitched and
unusual screaming, persistent unconsolable crying, and bulging fontanel
are compatible with an encephalopathy, but in and of themselves are not
conclusive evidence of encephalopathy.
42 U.S.C. § 300aa-14(b)(3)(A). An acute encephalopathy can be a Table injury for the
DTaP and MMR vaccines, and is indicated by "a significantly decreased level of
consciousness that lasts at least 24 hours," occurring within 72 hours after vaccination
(DTaP) or within five to fifteen days after vaccination (MMR). See 42 C.F.R.
§ 100.3(c)(2)(i)(A)(1) (2018).
9 Expressive aphasia is a defect or loss of motor skills. Dorland's Illustrated Medical
Dictionary, 115.
5
(capitalization and grammar in original). Petitioners assert they did not "seek emergency
treatment" for J.J.N.'s "symptoms of acute encephalopathy" as they were previously
reassured by medical practitioners that this lethargy was "normal" after routine
vaccinations. In their petition for compensation, petitioners state that J.J.N.'s "physical
and developmental assessments" at his November 25, 2014 checkup were "within normal
limits according to the petitioners age." 10
During the time this case was assigned to Special Master Thomas L. Gowen, he
ordered petitioners to file all relevant medical records and a statement of completion 11 by
November 28, 2017. 12 Special Master Gowen held a status conference with both parties
on March 27, 2018. On May 30, 2018, the Chief Special Master, pursuant to Vaccine Rule
3(d), reassigned the case to Special Master Brian H. Corcoran. As the original statutory
period for a decision had expired, 13 Special Master Corcoran allowed petitioners to submit
a notice of intent to remain in the Program, which petitioners did on June 29, 2018.
Thereafter, Special Master Corcoran held a status conference with both parties on July
12, 2018.
After the status conference, on July 16, 2018, Special Master Corcoran ordered
respondent to file a "Rule 4(c) Report[ 14] on or before August 31, 2018. Respondent
should also file a Motion to Dismiss (along with the report) if he [sic] deems appropriate
in light of the medical record evidence.'' See Order at 3, K.N. v. Sec'y of Health & Human
Servs., No. 17-1418V (Fed. Cl. Spec. Mstr. July 16, 2018). Also, in his July 16, 2018
Order, Special Master Corcoran advised J.J.N.'s mother to "continue to supplement the
record with additional medical records (e.g., proof of vaccination, birth records and
medical records prior to the vaccination, as well as records post-vaccination relating to
10 In the record before this court, that same checkup on November 25, 2014, noted a
"[c]all into Neurology and appts pending with Neuro and Developmental Peds."
11 A statement of completion is a statement by a petitioner, filed with the court, that
signifies "that petitioner believed that all relevant medical records had been filed.'' Dhanoa
v. Sec'y of Health & Human Servs., No. 15-1011V, 2017 WL 6276468, at *1.
12After several motions for extension of time, petitioners filed an amended petition and
some exhibits on February 14, 2018. A further motion for an extension of time was granted
by Special Master Gowen, giving petitioners until July 27, 2018 to file all records and the
statement of competition. A statement of completion, however, never was filed by
petitioners with the Office of Special Masters.
13The decision of the Special Master must "be issued as expeditiously as practicable but
not later than 240 days, exclusive of suspended time under subparagraph (C), after the
date the petition was filed." 42 U.S.C. § 300aa-12(d)(3)(A)(ii).
14The respondent, "[w]ithin 90 days after the filing of a petition, or in accordance with any
schedule set by the special master after petitioner has satisfied all required documentary
submissions," must file a report with a statement as to "why an award should or should
not be granted." Vaccine Rule 4(c)(1) (2018).
6
the injury and any relevant affidavits) in order to better support her claim." See id. at 2. In
addition, in his July 16, 2018 Order, Special Master Corcoran indicated that since the
Omnibus Autism Proceedings, 15 "no petitioners asserting non-Table causation claims
alleging that a child developed autism (or experienced an autistic-like developmental
regression) after receipt of a vaccine have succeeded in obtaining favorable entitlement
decisions." See id. at 1 (emphasis in original).
Respondent filed a Vaccine Rule 4(c) Report and a motion to dismiss for "failure
of proof" on August 31, 2018. In the Vaccine Rule 4(c) Report, respondent asserted that
medical personnel of the Division of Injury Compensation Programs at the Department of
Health and Human Services asserted that petitioners' case was not "appropriate for
compensation under the terms of the Vaccine Act." In the motion to dismiss, respondent
argued "J.J.N.'s records do not provide the requisite evidence to meet petitioners' burden
of proof and petitioners have not provided a reputable medical or scientific theory showing
that J.J.N.'s vaccinations caused any of J.J.N.'s various alleged symptoms.'' Respondent
stated that "a majority of the symptoms alleged in the Petition" are "commonly seen in
children with ASDs [Autism Spectrum Disorders].'' Respondent also noted that this court
has "consistently rejected other petitioners' characterizations of ASDs as an
encephalopathy or some other injury in an attempt to circumvent the binding effect of the
OAP [Omnibus Autism Proceedings] decisions." Furthermore, according to respondent,
"even if" some of the symptoms were distinct from J.J.N.'s Autism Spectrum Disorder,
"several of" them began before the beginning of the Act's "three-year limitations period"
and many do not satisfy the "six-month requirement" 16 because "they were transient in
nature.''
Despite Special Master Corcoran's guidance in his Rule 4 Order regarding the
need to supplement the record in order to support their petition, petitioners made no
substantive filings in the almost seven months between the status conference and the
15 Special Master Corcoran's July 16, 2018 Order contains a detailed footnote which
describes the Omnibus Autism Proceedings. He indicated that in the Omnibus Autism
Proceedings, after trying multiple cases, and issuance of:
[A] total of eleven lengthy decisions by special masters, the judges of the
U.S. Court of Federal Claims, and the panels of the U.S. Court of Appeals
for the Federal Circuit, unanimously rejected petitioners' claims. These
decisions found no persuasive evidence that the MMR vaccine or
thimerosal-containing vaccines caused autism.
See Order at 2 n.1, K. N. v. Sec'y of Health and Human Servs., No. 17-141 SV.
16 Pursuant to 42 U.S.C. § 300aa-11(c)(1)(D)(i), for either a Table claim or a non-Table
claim, a petition shall contain "supporting documentation[] demonstrating" that the
petitioners "suffered the residual effects or complications of such illness, disability, injury,
or condition for more than 6 months after the administration of the vaccine." 42 U.S.C.
§ 300aa-11(c)(1)(D)(i) (punctuation omitted).
7
February 4, 2019 dismissal of the case by Special Master Corcoran. The only filing
petitioners made was a statement opposing respondent's motion to dismiss, filed almost
four months after the motion to dismiss was filed and after the deadline set by the Special
Master. 17 The Special Master, however, did accept petitioners' late filing. In their
opposition to the motion to dismiss, petitioners asserted that dismissal would be
inappropriate because J.J.N. "requires further medical testing to determine the actual
scientific reason for his multiple inappropriate responses to routine vaccinations."
Petitioners assert that J.J.N.'s eczema is "relevant because it indicates that clearly [J.J.N.]
doesn't react appropriately to Dtap [sic].'' Petitioners also raised a new allegation that
J.J.N. may have a "mitochondrial or metabolic disorder," and indicated that a diagnosis
was "pending.'' In reference to J.J.N.'s alleged symptoms of an acute encephalopathy,
J.J.N.'s mother stated that she "believed this lethargy was normal under these
circumstances. As such I did not report his lethargy to anyone, nor did I seek appropriate
care for that lethargy.'' In his decision dismissing the case, Special Master Corcoran notes
that petitioners' opposition to the motion to dismiss largely recited factual allegations that
were not based on evidence in the record and that petitioners had provided no additional
evidence to support their claim. See K.N. v. Sec'y of Health & Human Servs., 2019 WL
1123016, at *3.
In his February 4, 2019 dismissal, Special Master Corcoran found the evidence
submitted by the petitioners to "not establish the Table requirements for encephalopathy,"
with regards to J.J.N.'s claim. See id. at *4. With regards to petitioners' Table claim of an
acute encephalopathy, Special Master Corcoran found petitioners' argument that the
"alarming degree of [J.J.N.'s] symptoms" and the alleged "3 days of acute lethargy" were
undocumented in the medical record because of "error" to be "not enough for a successful
Program claim." kl at *3-4. Special Master Corcoran found "no evidence" that J.J.N. had
"experienced an acute (meaning sufficient to require hospitalization) or subsequent
chronic encephalopathy after his September or November 2014 vaccinations.'' kl at *4.
Rather, Special Master Corcoran found the most compelling evidence of altered
consciousness to be J.J.N.'s possible seizure in the beginning of October 2014, and
incident falling off of the trampoline on November 8, 2014 that were both discussed at
J.J.N.'s December 11, 2014 neurologic evaluation. See id. These instances, as the
Special Master notes, "preceded the November vaccinations.'' See i9..,, (emphasis in
original). Special Master Corcoran took specific note that with regards to their Table claim
of acute encephalopathy, petitioners "did not file any such additional evidence, despite
17 Petitioners filed two motions for an extension of time. Each time, petitioners requested
an extension of ninety days. Special Master Corcoran granted in part and denied in part
both motions, giving petitioners thirty-five days for their first motion and twenty-one days
for their second motion, setting a filing due date of December 21, 2018 after petitioners'
second motion for an extension of time. In his order granting in part and denying in part
petitioners' first motion for an extension of time, Special Master Corcoran noted he
believed petitioners' request for an extension of "ninety days would cause undue delay in
the resolution of this matter and is therefore excessive.'' With regards to petitioners'
second motion for an extension of time, Special Master Corcoran indicated that he felt
the lengthy extension petitioners requested was "not reasonable or called for.''
8
having had more than three months to act since the filing of Respondent's motion to
dismiss." See id.
Regarding petitioners' various alleged non-Table claims, the Special Master found
the record "similarly unsupportive" of petitioners' claims. See id. Special Master Corcoran
found petitioners' assertion that J.J.N.'s eczema was proof of "a propensity for an
autoimmune response (which presumably occurred again after the November 2014
vaccinations) is also unsupported by the record." 18 lfL at *4 n.7. The "temporal
association" of J.J.N.'s symptoms and vaccinations, according to the Special Master, is
"not enough for a successful Program claim.'' See id. at *4. Special Master Corcoran also
indicated that "it appeared that the Petitioners wished to argue that J.J.N.'s autism was
vaccine-caused.'' lfL at *1. In his decision the Special Master stated, however, that
"attempting to characterize developmental symptoms as the secondary result of a
vaccine-induced encephalopathy" in a Program claim "had uniformly failed.'' lfL at *5. The
Special Master noted that in order to receive compensation under the Vaccine Program,
petitioners needed to prove that:
[E]ither (1) that he suffered a "Table lnjury"-i.e., an injury falling within the
Vaccine Injury Table-corresponding to one of J.J.N.'s vaccinations (in
which case establishing causation-in-fact is not required), or (2) that J.J.N.
suffered an injury that was actually caused by a vaccine. See Sections
13(a)(1 )(A) and 11 (c)(1 ). Petitioners seeking to establish entitlement via a
causation-in-fact must meet the three-prong test for such a claim set forth
by the [United States Court of Appeals for the] Federal Circuit in A/then v.
Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005).
See K.N. v. Sec'y of Health & Human Servs., 2019 WL 1123016, at *4 (italics and
parentheses in original) (citing 42 U.S.C. §§ 300aa-13(a)(1)(A) and 11(c)(1)). The Special
Master found that the petitioners had not "successfully distinguished this case from the
many autism claims that have been litigated unsuccessfully in the Program." lfL at *5.
The Special Master also stated that "Petitioners' desire to vary what the existing
records establish with their own recollections fly in the face of long-standing Program law
holding that contemporaneous records are deemed accurate except in limited
circumstances not established to be relevant here." lfL at *4 (citing Burns v. Sec'y of
Health & Human Servs., 3 F.3d 415,417 (Fed. Cir. 1993)). Because the petition was not
18 The Special Master noted that J.J.N. was assessed by an allergist, "and the
assessment was atopic dermatitis, allergic rhinitis, and recurrent bacterial infection ....
No treater, however, linked any of the above to the DTaP vaccine or deemed it out of the
ordinary.'' K.N. v. Sec'y of Health & Human Servs., 2019 WL 1123016, at *4 n.7 (citation
omitted).
9
"supported by either medical records or by the opinion of a competent physician," Special
Master Corcoran found that petitioners' claim "must be dismissed." 19 & at *5.
On February 13, 2019, after their claim was dismissed by Special Master
Corcoran, petitioners filed a "Notice of Appeal" improperly titled as an appeal to the United
States Court of Appeals for the Federal Circuit. Petitioners should have filed a motion for
review in the United States Court of Federal Claims. See Vaccine Rule 23. On February
22, 2019, Special Master Corcoran issued a Deficiency Order directing petitioners to file
a proper "motion for review" with this court. In the Deficiency Order, Special Master
Corcoran informed the petitioners they had to seek review by March 7, 2019, although
the statutory deadline was March 6, 2019. Based on the Special Master's direction,
petitioners filed their motion for review and memorandum of objection in this court on
March 7, 2019. Following remand to the Special Master, Special Master Corcoran issued
an Order on March 15, 2019, which stated, "[p]etitioners' initial filing could reasonably be
deemed to have satisfied the temporal requirements for motions for review under the
[Vaccine] Act and the Vaccine Rules." Order on Remand at 3, K.N. v. Sec'y of Health &
Human Servs., No. 17-1418V (Fed. Cl. Spec. Mstr. March 15, 2019). Acknowledging
petitioners' pro se status and his own calculation error, the Special Master stated that it
was "proper to deem Petitioners' February 13, 2019 submission to the clerk's office as a
timely motion for review of my February 4th Decision with the Court of Federal Claims."
.kl The petition now comes to this court on petitioners' motion.
In this court, petitioners "respectfully request that the court Reconsider this petition,
and supporting proof." Petitioners now also allege that since the dismissal of their claim
they have made discoveries that "support [the] petition" and are "awaiting a genetic
diagnosis.',zo In their memorandum of objection, filed with their motion for review,
19 With regards to petitioners' claim in their amended petition that J.J.N. experienced an
alleged reaction to a hepatitis A vaccine, the Special Master noted that "Petitioners'
Opposition makes no mention of their prior assertion that J.J.N. experienced some kind
of reaction after receiving the Hep A vaccine in January 2018, and I similarly find that the
record is not supportive of a Vaccine Program award based upon such allegations." K.N.
v. Sec'y of Health & Human Servs., 2019 WL 1123016, at *4 n.6.
20Along with their motion for review petitioners submitted over 350 new pages of medical
records, therapy reports, and school evaluations for J.J.N. to this court, which had not
been submitted to Special Master Corcoran prior to his dismissal of petitioners' claim.
Because the new evidence never was submitted to Special Master Corcoran, it is not
properly before this court on review of the Special Master's decision, and, therefore, is
not part of the record for the court's current review. Vaccine Rule 8 guides submission of
evidence, and Vaccine Rule 8(f)(1) specifically states that "[a]ny fact or argument not
raised specifically in the record before the special master will be considered waived and
cannot be raised by either party in proceedings on review of a special master's decision."
Vaccine Rule 8(f)(1) (2018). Even a brief review of petitioners' attempted filing of
supplemental records, however, does not appear to provide evidence to prove that J.J.N.
suffered an acute encephalopathy or developmental regression from his vaccinations.
10
petitioners try to assert a new argument that was not before the Special Master, and
allege that J.J.N.'s reaction to the vaccines occurred because "he most probably has a
mitochondrial disorder caused by an X linked genetic disorder which both the petitioners
and his healthcare providers were unaware of at the time both sets of 'catch up' vaccines
were administered on sept 24 and Nov 25 of 2014.'' Petitioners assert this disorder is
proven by signs of "[m]etabolic dysfunction" and that "[t]his genetic disorder is thought to
be incredibly rare, due to particularly rare abnormality of [J.J.N.'s] corpus callosum," but
note that "specific diagnosis is pending.'' In their memorandum of objection, filed with the
motion for review with this court, petitioners now allege that "a mitochondrial disorder that
we were unaware of caused an immune stimulation that required more metabolic energy
then available," which, "after his September 24, 2014 immunizations," caused J.J.N. to
have "developed significant neurological symptoms over the period of several weeks.'' 21
This "mitochondrial disorder" is alleged by petitioners lo have "manifested in regressive
encephalopathy with features of autism spectrum disorder.''
The new submission is speculative, unconnected, and largely not relevant to the
allegations raised by petitioners before Special Master Corcoran, and now under review
by this court. Therefore, even if the additional evidence petitioners tried to submit to this
court was properly before this court, which it is not, or had been before the Special Master,
the newly submitted evidence would not appear to change the determination in this case.
21 As indicated above, with their filing in this court, together with petitioners' memorandum
of objection, petitioners submitted, and tried to rely on, additional documents, including
an affidavit and examination records apparently authored by Dr. Andrew Zimmerman,
which were not submitted to the Special Master before he issued his decision and, which
therefore, are not properly before this court. Petitioners allege Dr. Zimmerman cared for
J.J.N. for "a short period of time.'' Petitioners attempted to file selected pages of records
from a one hour examination of J.J.N. by Dr. Zimmerman on May 17, 2018, forty minutes
of which are described as counseling, and also attempted to file pages from a brief thirty
minute follow-up examination of J.J.N., on July 10, 2018, of which twenty minutes are
described as counseling.
Based on Dr. Zimmerman's affidavit, petitioners argue that "there were exceptions in
which vaccinations could cause autism," and that the reason the vaccinations caused
J.J.N.'s autism is "a genetic abnormality.'' The court notes, however, that the patient in
the affidavit to which Dr. Zimmerman refers is a patient other than J.J.N., and appears to
have been submitted in an unrelated case. Petitioners assert that at the May 17, 2018
visit with Dr. Zimmerman, they mentioned obtaining lab testing of "metabolic functions,"
and that they raised their concern about J.J.N.'s reaction to the "DTaP" vaccines, as well
as "any other underlying disease causing [J.J.N.'s] ASD [Autism Spectrum Disorder]."
The court notes that at the July 10, 2018 follow-up examination there was no mention of
anything conclusive other than that J.J.N.'s "metabolic profile" was "normal.''
Moreover, as the respondent asserts, Dr. Zimmerman stated in his affidavit that his
"opinions as to vaccine causation were case-specific," and that Dr. Zimmerman
"evaluated J.J.N.'' and that Dr. Zimmerman "did not attribute J.J.N.'s ASD to vaccines.''
11
On April 5, 2019, respondent filed a response to petitioners' motion for review in
this court. In the response, respondent requests this court affirm the decision of Special
Master Corcoran because the Special Master "correctly concluded" that the record did
not prove J.J.N. suffered a Table injury of acute encephalopathy. With regards to
petitioners' various non-Table claims, respondent argues that Special Master Corcoran
"correctly concluded that the record does not support a claim that J .J. N. suffered a
reaction to his September and/or November 2014 vaccinations that explains his
neurological symptoms." Respondent also argues that petitioners have not established
that their claim is more than a "temporal association," and requests that this court affirm
the Special Master's decision because "Petitioners have failed to demonstrate that the
Special Master erred, or that his actions were arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with the law." Remarking that petitioners did not file an
expert report while the Special Master was considering the case, respondent also argues
that petitioners' new filings submitted with their motion for review are "not properly before
this Court" according to Vaccine Rule 8.
DISCUSSION
When reviewing a Special Master's decision, the assigned Judge of the United
States Court of Federal Claims shall:
(A) uphold the findings of fact and conclusions of law of the special master
and sustain the special master's decision,
(B) set aside any findings of fact or conclusions of law of the special master
found to be arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law and issue its own findings of fact and conclusions of
law, or
(C) remand the petition to the special master for further action in accordance
with the court's direction.
42 U.S.C. § 300aa-12(e)(2). The legislative history of the Vaccine Act states: 'The
conferees have provided for a limited standard for appeal from the [special] master's
decision and do not intend that this procedure be used frequently, but rather in those
cases in which a truly arbitrary decision has been made." H.R. Rep. No. 101-386, at 517
(1989) (Conf. Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.
In order to recover under the Vaccine Act, a petitioner "must show, by a
preponderance of the evidence, "that the injury or death at issue was caused by a
vaccine." Milik v. Sec'y of Health & Human Servs., 822 F.3d 1367, 1379 (Fed. Cir. 2016);
(quoting Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1341 (Fed.
Cir. 2010) (citing 42 U.S.C. §§ 300aa-11(c)(1), -13(a)(1)); see also W.C. v. Sec'y of
Health & Human Servs., 704 F.3d 1352, 1355-56 (Fed. Cir. 2013) ("The Vaccine Act
created the National Vaccine Injury Compensation Program, which allows certain
petitioners to be compensated upon showing, among other things, that a person
'sustained, or had significantly aggravated' a vaccine-related 'illness, disability, injury, or
12
condition."' (quoting 42 U.S.C. § 300aa-11 (c)(1)(C))); Lombardi v. Sec'y of Health &
Human Servs., 656 F.3d 1343, 1350 (Fed. Cir. 2011) ("A petitioner seeking compensation
under the Vaccine Act must prove by a preponderance of the evidence that the injury or
death at issue was caused by a vaccine."); see also Shapiro v. Sec'y of Health & Human
Servs., 105 Fed. Cl. 353, 358 (2012), aff'd, 503 F. App'x 952 (Fed. Cir. 2013); Jarvis v.
Sec'y of Health & Human Servs., 99 Fed. Cl. 47, 54 (2011).
As the United States Court of Appeals for the Federal Circuit explained:
A petitioner can establish causation in one of two ways. !fl [Broekelschen
v. Sec'y of Health & Human Servs., 618 F.3d at 1341] If the petitioner
shows that he or she received a vaccination listed on the Vaccine Injury
Table, 42 U.S.C. § 300aa-14, and suffered an injury listed on that table
within a statutorily prescribed time period, then the Act presumes the
vaccination caused the injury. Andreu v. Sec'y of Health & Human Servs.,
569 F.3d 1367, 1374 (Fed. Cir. 2009). Where, as here, the injury is not on
the Vaccine Injury Table, the petitioner may seek compensation by proving
causation-in-fact.
Milik v. Sec'y of Health & Human Servs., 822 F.3d at 1379 (citing Andreu v. Sec'y of
Health & Human Servs., 569 F.3d at 1374); see also Grant v. Sec'y of Health & Human
Servs., 956 F.2d 1144, 1147-48 (Fed. Cir. 1992). The Federal Circuit has held that
causation-in-fact in the Vaccine Act context is the same as the "legal cause" in the general
torts context. See Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed.
Cir. 1999). Therefore, drawing from the Restatement (Second) of Torts, the vaccine is a
cause-in-fact when it is "a substantial factor in bringing about the harm." de Bazan v.
Sec'y of Health & Human Servs., 539 F.3d 1347, 1351 (Fed. Cir.), reh'g and reh'g en
bane denied (Fed. Cir. 2008) (quoting the Restatement (Second) of Torts§ 431(a)); see
also Deribeaux ex rel. Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d 1363,
1367 (Fed. Cir.) reh'g and reh'g en bane denied (Fed. Cir. 2013) ('To prove causation, a
petitioner must show that the vaccine was 'not only a but-for cause of the injury but also
a substantial factor in bringing about the injury."' (quoting Shyface v. Sec'y of Health &
Human Servs., 165 F.3d at 1352-53)). A "'substantial factor' standard requires a greater
showing than 'but for' causation." de Bazan v. Sec'y of Health & Human Servs., 539 F.3d
at 1351 (quoting Shyface v. Sec'y of Health & Human Servs., 165 F.3d at 1352).
"However, the petitioner need not show that the vaccine was the sole or predominant
cause of her injury, just that it was a substantial factor." !fl (citing Walther v. Sec'y of
Health & Human Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007)).
Under the off-Table theory of recovery, a petitioner is entitled to compensation if
he or she can demonstrate, by a preponderance of the evidence, see 42 U.S.C. § 300aa-
13(a)(1 )(A), that the recipient of the vaccine sustained, or had significantly aggravated,
an illness, disability, injury, or condition not set forth in the Vaccine Injury Table, but which
was caused by a vaccine that is listed on the Vaccine Injury Table. See 42 U.S.C.
§ 300aa-11 (c)(1)(C)(ii)(I); see also Lalonde v. Sec'y of Health & Human Servs., 746 F.3d
1334, 1339 (Fed. Cir. 2014); W.C. v. Sec'y of Health & Human Servs., 704 F.3d at 1356
13
("Nonetheless, the petitioner must do more than demonstrate a 'plausible' or 'possible'
causal link between the vaccination and the injury; he must prove his case by a
preponderance of the evidence." (quoting Moberly ex rel. Moberly v. Sec'y of Health &
Human Servs., 592 F.3d at 1322)); Althen v. Sec'y of Health & Human Servs., 418 F.3d
at 1278; Hines on Behalf of Sevier v. Sec'y of Health & Human Servs., 940 F.2d at 1525.
While scientific certainty is not required, the Special Master "is entitled to require some
indicia of reliability to support the assertion of the expert witness." Moberly ex rel. Moberly
ex rel. v. Sec'y of Health & Human Servs., 592 F.3d at 1324; see also Hazlehurst v. Sec'y
of Health & Human Servs., 88 Fed. Cl. 473, 439 (2009), aff'd, 604 F.3d 1343 (Fed. Cir.
2010) (quoting Andreu ex rel. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367,
1379 (Fed. Cir. 2009)).
According to the United States Court of Appeals for the Federal Circuit, the
preponderance of evidence standard is "one of proof by a simple preponderance, of 'more
probable than not causation.'" Althen v. Sec'y of Health & Human Servs., 418 F.3d at
1279-80 (citing concurrence in judgment in Hellebrand v. Sec'y of Health & Human
Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993)); see also W.C. v. Sec'y of Health &
Human Servs., 704 F.3d at 1356 ("In this off-table case, the petitioner must show that it
is 'more probable than not' that the vaccine caused the injury.'' (quoting Althen v. Sec'y
of Health & Human Servs., 418 F.3d at 1279-80)). A petitioner who meets this burden is
then entitled to recovery under the Vaccine Act, unless the respondent proves by
preponderant evidence that the injury was caused by factors unrelated to the vaccine.
See Stone v. Sec'y of Health & Human Servs., 676 F.3d 1373, 1379-80 (Fed. Cir. 2012);
see also Rus v. Sec'y of Health & Human Servs., 129 Fed. Cl. 672,680 (2016) (citing 42
U.S.C. § 300aa-13(a)(1)(B); Shalala v. Whitecotton, 514 U.S. 268, 270-71 (1995));
Walther v. Sec'y of Health & Human Servs., 485 F.3d at 1151. "But, regardless of whether
the burden of proof ever shifts to the respondent, the special master may consider the
evidence presented by the respondent in determining whether the petitioner has
established a prima facie case.'' Rus v. Sec'y of Health & Human Servs., 129 Fed. Cl. at
680 (citing Stone v. Sec'y of Health & Human Servs., 676 F.3d at 1379; de Bazan v. Sec'y
of Health & Human Servs., 539 F.3d at 1353).
In Markovich v. Secretary of Health and Human Services, the United States Court
of Appeals for the Federal Circuit wrote, "[u]nder the Vaccine Act, the Court of Federal
Claims reviews the Chief Special Master's decision to determine if it is 'arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with the law.' 42 U.S.C.
§ 300aa-12(e)(2)(B).'' Markovich v. Sec'y of Health & Human Servs., 477 F.3d 1353,
1355-56 (Fed. Cir.), cert. denied, 552 U.S. 816 (2007); see also Deribeaux ex rel.
Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d at 1366 (The United States Court
of Appeals for the Federal Circuit stated that "we 'perform[ ] the same task as the Court
of Federal Claims and determine[ ] anew whether the special master's findings were
arbitrary or capricious."' (quoting Lampe v. Sec'y of Health & Human Servs., 219 F.3d
1357, 1360 (Fed. Cir. 2000))) (brackets in original); W.C. v. Sec'y of Health & Human
Servs., 704 F.3d at 1355; Hibbard v. Sec'y of Health & Human Servs., 698 F.3d 1355,
1363 (Fed. Cir. 2012); Avera v. Sec'y of Health & Human Servs., 515 F.3d 1343, 1347
(Fed. Cir.) ("Under the Vaccine Act, we review a decision of the special master under the
14
same standard as the Court of Federal Claims and determine if it is 'arbitrary, capricious,
an abuse of discretion, or otherwise not in accordance with law."' (quoting 42 U.S.C.
§ 300aa-12(e)(2)(B))), reh'g and reh'g en bane denied (Fed. Cir. 2008); de Bazan v. Sec'y
of Health & Human Servs., 539 F.3d at 1350; Althen v. Sec'y of Health & Human Servs.,
418 F.3d 1274, 1277 (Fed. Cir. 2005); Dodd v. Sec'y of Health & Human Servs., 114 Fed.
Cl. 43, 47 (2013); Taylor v. Sec'y of Health & Human Servs., 108 Fed. Cl. 807, 817 (2013).
The arbitrary and capricious standard is "well understood to be the most deferential
possible." Munn v. Sec'y of Health & Human Servs., 970 F.2d 863, 870 (Fed. Cir. 1992).
This court may set aside a Special Master's decision only if the court determines
that the "findings of fact or conclusion of law of the special master ... [are] arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law .... " 42
U.S.C. § 300aa-12(e)(2)(B); see also Lombardi v. Sec'y of Health & Human Servs., 656
F.3d at 1350 ("We uphold the special master's findings of fact unless they are arbitrary or
capricious.") (internal citations omitted); Moberly ex rel. Moberly v. Sec'y of Health &
Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Markovich v. Sec'y of Health &
Human Servs., 477 F.3d at 1356-57; Lampe v. Sec'y of Health & Human Servs., 219 F.3d
at 1360. The United States Court of Appeals for the Federal Circuit has indicated that:
These standards vary in application as well as degree of deference. Each
standard applies to a different aspect of the judgment. Fact findings are
reviewed by us, as by the Claims Court judge, under the arbitrary and
capricious standard; legal questions under the "not in accordance with law"
standard ... ; and discretionary rulings under the abuse of discretion
standard. The latter will rarely come into play except where the special
master excludes evidence.
Munn v. Sec'y of Health & Human Servs., 970 F.2d at 871 n.10; see also Carson ex rel.
Carson v. Sec'y of Health & Human Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013);
Deribeaux ex rel. Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d at 1366; W.C.
v. Sec'y of Health & Human Servs., 704 F.3d at 1355; Griglock v. Sec'y of Health &
Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012); Porter v. Sec'y of Health & Human
Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011) (citing Broekelschen v. Sec'y of Health &
Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010)) (explaining that the reviewing court
"do[es] not reweigh the factual evidence, assess whether the special master correctly
evaluated the evidence, or examine the probative value of the evidence or the credibility
of the witnesses-these are all matters within the purview of the fact finder") reh'g and
reh'g en bane denied (Fed. Cir. 2012); Dodd v. Sec'y of Health & Human Servs., 114 Fed.
Cl. at 56. "[T]he special masters have broad discretion to weigh evidence and make
factual determinations." Dougherty v. Sec'y of Health & Human Servs., 141 Fed. Cl. 223,
229 (2018). "With regard to both fact-findings and fact-based conclusions, the key
decision maker in the first instance is the special master. The Claims Court owes these
findings and conclusions by the special master great deference - no change may be
made absent first a determination that the special master was 'arbitrary and capricious."'
Munn v. Sec'y of Health & Human Servs., 970 F.2d at 870; see also 42 U.S.C. § 300aa-
12(e)(2)(B).
15
Generally, "if the special master 'has considered the relevant evidence of record,
drawn plausible inferences and articulated a rational basis for the decision, reversible
error will be extremely difficult to demonstrate."' Hibbard v. Sec'y of Health & Human
Servs., 698 F.3d at 1363 (quoting Hines on Behalf of Sevier v. Sec'y of Health & Human
Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991 )); see also Porter v. Sec'y of Health & Human
Servs., 663 F.3d at 1253-54; Lampe v. Sec'y of Health & Human Servs., 219 F.3d at
1360; Avila ex rel. Avila v. Sec'y of Health & Human Servs., 90 Fed. Cl. 590, 594 (2009);
Dixon v. Sec'y of Health & Human Servs., 61 Fed. Cl. 1, 8 (2004) ("The court's inquiry in
this regard must therefore focus on whether the Special Master examined the 'relevant
data' and articulated a 'satisfactory explanation for its action including a "rational
connection between the facts found and the choice made." (quoting Motor Vehicle Mfrs.
Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (quoting Burlington Truck
Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)))).
As noted by the United States Court of Appeals for the Federal Circuit:
Congress assigned to a group of specialists, the Special Masters within the
Court of Federal Claims, the unenviable job of sorting through these painful
cases and, based upon their accumulated expertise in the field, judging the
merits of the individual claims. The statute makes clear that, on review, the
Court of Federal Claims is not to second guess the Special Masters [sic]
fact-intensive conclusions; the standard of review is uniquely deferential for
what is essentially a judicial process. Our cases make clear that, on our
review . . . we remain equally deferential. That level of deference is
especially apt in a case in which the medical evidence of causation is in
dispute.
Deribeaux ex rel. Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d at 1366-67
(quoting Hodges v. Sec'y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993))
(modification in original); Hibbard v. Sec'y of Health & Human Servs., 698 F.3d at 1363;
Locane v. Sec'y of Health & Human Servs., 685 F.3d 1375, 1380 (Fed. Cir. 2012). The
Court of Appeals for the Federal Circuit further has explained that the reviewing courts
"'do not sit to reweigh the evidence. [If] the special master's conclusion [is] based on
evidence in the record that [is] not wholly implausible, we are compelled to uphold that
finding as not being arbitrary and capricious."' See Deribeaux ex rel. Deribeaux v. Sec'y
of Health & Human Servs., 717 F.3d at 1367 (quoting Lampe v. Sec'y of Health & Human
Servs., 219 F.3d at 1363) (modification in original); see also Hibbard v. Sec'y of Health &
Human Servs., 698 F.3d at 1363 (citing Cedillo v. Sec'y of Health & Human Servs., 617
F.3d 1328, 1338 (Fed. Cir. 2010)).
The Special Master has discretion to determine the relative weight of evidence
presented, including contemporaneous medical records and oral testimony. See Burns v.
Sec'y of Health & Human Servs., 3 F.3d at 417 (finding that the Special Master had
thoroughly considered evidence in record, had discretion not to hold an additional
evidentiary hearing); Hibbard v. Sec'y of Health & Human Servs., 698 F.3d at 1368
16
petitioners filed no additional medical records or an expert report with Special Master
Corcoran.
In his decision dismissing the case for insufficient proof, the Special Master fully
explained why, based on the record before him, he found the record to be insufficient to
establish petitioners' Table claim of acute encephalopathy or petitioners' various non-
Table claims. Special Master Corcoran stated:
Petitioners' desire to vary what the existing records establish with their own
recollections fly in the face of long-standing Program law holding that
contemporaneous records are deemed accurate except in limited
circumstances not established to be relevant here .... And in any event,
Petitioners did not file any such additional evidence, despite having had
more than three months to act since the filing of Respondent's motion to
dismiss.
JiL at *4 (citation omitted).
Regarding petitioners' Table claim of acute encephalopathy, Special Master
Corcoran explained in his dismissal that petitioners' allegations required proof of "a
significantly decreased level of consciousness that lasts at least 24 hours" occurring
within 72 hours after vaccination [DTaP] or within five to fifteen days after vaccination
[MMR) to constitute a valid Table claim for either the DTaP or the MMR vaccines. See 42
C.F.R. § 100.3(c)(2)(i)(A)(1). According to petitioners' exhibits, J.J.N. did not receive the
DTaP or MMR vaccinations at the September 24, 2014 physical examination and so the
only time period in question with regards to petitioners' Table claim for an alleged acute
encephalopathy only could have been following the November 25, 2014 vaccinations.
Special Master Corcoran did not find petitioners to have established their allegation that
J.J.N. suffered a Table claim of an acute encephalopathy because "[!]he
contemporaneous medical record establishes no evidence" of J.J.N.'s symptoms at the
relevant time. See K.N. v. Sec'y of Health & Human Servs., 2019 WL 1123016, at *4. The
Special Master indicated that "J.J.N.'s instances of altered consciousness preceded the
November vaccinations, further harming the argument that that date was the start of a
Table encephalopathy, and the most alarming medical occurrence after the September
vaccinations was the October tick bite." JiL (emphasis in original). The court agrees with
the Special Master's conclusion that the medical record does not support a claim of J.J.N.
experiencing an acute encephalopathy following his November 25, 2014 vaccinations.
Special Master Corcoran also found in his dismissal that the record is "similarly
unsupportive" of petitioners' various non-Table claims that, according to the petitioners,
J.J.N. experienced "a reaction to his September and November 2014 vaccinations-
whether separately or together culminating in the ASD [Autism Spectrum Disorder]
symptoms he has experienced." See J.l;l (footnote omitted). Special Master Corcoran
wrote in his dismissal that "Petitioners have not successfully distinguished this case from
the many autism claims that have been litigated unsuccessfully in the Program." JiL at *5.
The Special Master also pointed out that "non-Table claims alleging a vaccine-caused
18
developmental problem (whether or not the petitioners agreed it was autism) decided
since the conclusion of the OAP [Omnibus Autism Proceedings] had uniformly failed."~
(citing Thompson v. Sec'y of Health & Human Servs., 2017 WL 2926614, at *13 (Fed. Cl.
Spec. Mstr. May 16, 2017) (citing Wolfv. Sec'y of Health & Human Servs., No. 14-342V,
2016 WL 651858, at *15 (Fed. Cl. Spec. Mstr. Sept. 15, 2016))).
With regards to petitioners' claim that J.J.N.'s alleged eczema was proof that he
"doesn't react appropriately to Dtap [sic]," Special Master Corcoran correctly noted that
"Petitioners' assertions that J.J.N. displayed a sensitivity to the DTaP vaccine, revealed
in the winter of 2014 after receiving initial doses of it, and that this sensitivity reflects a
propensity for an autoimmune response (which presumably occurred again after the
November 2014 vaccinations) is also unsupported by the record.'' K.N. v. Sec'y of Health
& Human Servs., 2019 WL 1123016, at *4 n.7.
Petitioners, in their motion for review in this court, now allege a new theory which
was not before the Special Master and, therefore, is not properly before this court, but
which petitioners have apparently developed since the deadlines for submitting proof to
the Special Master and when the Special Master dismissed their case. Petitioners now
argue that this theory proves that J.J.N.'s vaccinations "'significantly aggravated an
underlying metabolic disorder, which predisposed her' (in this situation JJN) 'to deficits in
cellular energy metabolism' . . . 'and manifested in regressive encephalopathy with
features of autism spectrum disorder.'" Petitioners assert that J.J.N. "most probably has
a mitochondrial disorder caused by an X linked genetic disorder which both the petitioners
and his healthcare providers were unaware of at the time both sets of 'catch up' vaccines
were administered on sept 24 and Nov 25 of 2014." There is no medical evidence in the
record that J.J.N. actually has a metabolic disorder or experienced a regressive
developmental encephalopathy. Even if petitioners' attempted new filings were properly
before this court, which, as discussed above, they are not, those filings are unsupportive
of petitioners' claim. Even the testing of J.J.N. for an X-linked disorder, which petitioners
assert is the cause of the "mitochondrial disorder," was negative. Moreover, the only
primary care provider to assess J.J.N. with a metabolic disorder never addressed the
cause of the dysfunction in J.J.N., nor the symptoms he may have experienced as a
result.
The record before the court supports the Special Master's decision to dismiss
petitioners' case for insufficient proof and demonstrates that Special Master Corcoran
rationally concluded that petitioners' exhibits and personal recollections do not overcome
the presumption in favor of the information contained in the contemporaneous medical
record. See Carson ex rel. Carson v. Sec'y of Health & Human Servs., 727 F.3d at 1369;
see also Porter v. Sec'y of Health & Human Servs., 663 F.3d at 1253-54; Munn v. Sec'y
of Health & Human Servs., 970 F.2d at 870. As indicated above, with exceptions that
petitioners have not proven here, the existing case law consistently has found
contemporaneous medical records to be weighed more than oral testimony after the fact.
Murphy v. Sec'y of Health & Human Servs., 23 Cl. Ct. at 733 (citing United States v.
United States Gypsum Co., 333 U.S. at 396 ("It has generally been held that oral
19
testimony which is in conflict with contemporaneous documents is entitled to little
evidentiary weight.")).
Petitioners have provided no reputable medical or scientific explanation to support
the claims alleged in their petition. See Grant v. Sec'y of Health & Human Servs., 956
F.2d at 1148 (The Federal Circuit determined a "reputable medical or scientific
explanation" to be "evidence in the form of scientific studies or expert medical
testimony."). As petitioners have presented no evidence to establish vaccine induced
causation, and because "[t]he special master or court may not make such a finding based
on the claims of a petitioner alone," the Special Master's decision was not arbitrary,
capricious, an abuse of discretion or contrary to law. See 42 U.S.C. § 300aa-13(a)(1).
This court, therefore, affirms Special Master Corcoran's February 4, 2019 dismissal of
petitioners' claims. While this court sympathizes with petitioners regarding any medical
difficulties J.J.N. may have experienced, or is continuing to experience, petitioners have
not offered sufficient proof that J.J.N.'s alleged encephalopathy or other alleged
symptoms, including "features of autism spectrum disorder," were caused by the
vaccinations he received.
CONCLUSION
As determined above, upon review of the evidence admitted into the record before
the Special Master, the court AFFIRMS Special Master Corcoran's finding of insufficient
evidence to meet petitioners' burden of proof and the Special Master's denial of
petitioners' claim for compensation on behalf of J.J.N.
IT IS SO ORDERED.
/{?q``
MARIAN Bt.:NKHORN
Judge
20