V. v. Secretary of Health and Human Services ( 2021 )

In the United States Court of Federal Claims
No. 16-1505
(Filed Under Seal: December 8, 2021)
(Reissued for Publication: December 28, 2021) 1
***************************************
O.M.V., *
*
*
Petitioner, * Entitlement; Influenza (“Flu”) Vaccine;
* Off-Table Injury; Acute Disseminated
v. * Encephalomyelitis (“ADEM”); Multiple
* Sclerosis (“MS”); Demyelinating Condition.
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
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Edward M. Kraus, Law Offices of Chicago Kent, Chicago, IL, for Petitioner.
Emilie Williams, U.S. Department of Justice, Washington, DC, for Respondent.
ORDER AND OPINION
DIETZ, Judge.
Petitioner, O.M.V., seeks review of a decision by Special Master Nora Beth Dorsey,
denying him compensation under the National Vaccine Injury Compensation Program (“Vaccine
Act”). Petitioner alleges he was injured by an influenza (“flu”) vaccine received on November
15, 2013. He filed for compensation on November 14, 2016. The Special Master denied relief on
the ground that Petitioner failed to prove by a preponderance of the evidence that the vaccination
caused his injury. Petitioner timely filed a motion for review. For the reasons stated below,
Petitioner’s Motion for Review is denied, and the Special Master’s decision denying entitlement
is sustained.
1
Pursuant to Vaccine Rule 18(b) of the Rules of the United States Court of Federal Claims, the Court issued this
Order and Opinion under seal on December 8, 2021 to provide the parties an opportunity to submit redactions. See
ECF No. 137. The parties did not submit any redactions by the December 22, 2021 deadline. Accordingly, the Court
now publishes this Order and Opinion without redactions.
I. BACKGROUND 2
On November 15, 2013, Petitioner, at thirty-nine years old, received a trivalent flu
vaccine upon returning from a medical trip in Bolivia. O.M.V. v. Sec'y of Health & Hum. Servs.,
No. 16-1505V, 2021 WL 3183719, at *6 (Fed. Cl. Spec. Mstr. June 16, 2021). At the time
Petitioner received the vaccine, he was working as a pediatrician. Id. at *17. Petitioner had no
neurological symptoms prior to vaccination. Id.
A. Medical History
The day after he received the vaccine, Petitioner experienced an episode of confusion,
weakness, problems with balance and tingling on the left side of his body, including scalp, face,
arm, and leg. Pet’r’s Mem. in Supp. of Mot. for Review at 2, ECF No. 127 [hereinafter Pet’r’s
Mot.]. Petitioner visited a nearby urgent care facility on the same day and complained of
“bilateral facial numbness . . . and left arm weakness[.]” O.M.V., 2021 WL 3183719, at *6. After
being examined, Petitioner was diagnosed with generalized weakness and an acute severe
migraine headache. Id.The following week, Petitioner sought emergency treatment at a different urgent care
facility complaining of left-side weakness, drooping in the face, and left arm weakness. O.M.V.,
2021 WL 3183719, at *6. The examining doctor diagnosed Petitioner with weakness of his left
upper extremity and advised that he follow up with Dr. Mark Alan Simaga, a neurologist. Id. The
next day, Petitioner’s condition worsened, which prompted him to visit an emergency room
where he complained of continued weakness in his arm and difficulty grasping items, focusing,
and putting words together. Id. at *7. After rendering a physical examination, the examining
doctor ordered multiple tests, including labs, electrocardiogram (“EKG”), and brain MRI—all of
which came back normal. Id. The MRI showed no evidence of a demyelinating disorder. Id.
Petitioner was diagnosed with paresthesia and stroke/cerebrovascular accident (“CVA”) then
discharged. Id.
On January 14, 2014, Petitioner was seen by Dr. Simaga, who diagnosed him with
transient ischemic attack (“TIA”) and hemiplegic migraine. O.M.V., 2021 WL 3183719, at *7.
Dr. Simaga also ordered numerous tests, including labs and MRIs, and prescribed Plavix for
Petitioner. Id.On January 29, 2014, Petitioner was evaluated by Dr. Krista Molina, a primary care
physician. O.M.V., 2021 WL 3183719, at *8. Dr. Molina diagnosed Petitioner with TIA, left arm
weakness, left leg weakness, and left facial numbness. Id. Dr. Molina then re-ordered tests,
referred Petitioner to the neurology department, and encouraged Petitioner to take Plavix daily
and continue Pravachol. Id. Petitioner underwent an ultrasound and an EKG that day, both of
2
The factual background is derived from the Special Master’s Decision. O.M.V. v. Sec'y of Health & Hum. Servs.,
No. 16-1505V, 2021 WL 3183719, at *6-20 (Fed. Cl. Spec. Mstr. June 16, 2021).
2
which came back normal. Id. Petitioner’s symptoms were noted to have “started [one] day after
flu shot, [two] days after a long plane trip.” Id. On February 8, 2014, a brain MRI and blood tests
were conducted, which were either normal or unremarkable. Id.Petitioner’s condition continued to worsen. O.M.V., 2021 WL 3183719, at *8-9. On April
5, 2014, Petitioner was admitted to an emergency room where he complained of “[s]udden onset
of left parietal headache associated with left facial numbness and left upper extremity numbness
and weakness with abnormal gait.” Id. at *9. Petitioner also reported that his “headache was
much different than his usual migraine headache” and that it had lasted for about four hours. Id.
Upon examination, the examining doctor diagnosed Petitioner with “left face numbness, left face
and left-sided weakness and paresthesia, TIA versus complicated migraine, as well as borderline
dyslipidemia.” Id. Petitioner was admitted for observation. Id. The next day, however, Petitioner
underwent a neurology consultation with Dr. Arkadiy Konyukhov, who noted that a repeat MRI
of Petitioner’s brain was normal, “except possible very small FLAIR hyperintensity in the right
parieto-occipital white matter.” Id. Petitioner was discharged with a diagnosis of “probable
hemiplegic migraines or dyslipidemia.” Id. MRIs of Petitioner’s thoracic and cervical spines
performed on May 6, 2014 were unremarkable, and no lesions were seen. Id.
In July 2014, Petitioner’s treating physicians considered a diagnosis of a demyelinating
disease. O.M.V., 2021 WL 3183719, at *9. On July 1, Petitioner received a lumbar puncture, and
Petitioner’s cerebrospinal fluid (“CSF”) showed five well-defined oligoclonal bands in the CSF
that were not present in the corresponding serum sample. Id. Petitioner saw Dr. Konyukhov on
July 14 for further evaluation of his ongoing left-sided weakness, numbness, and periods of
confusion. Id. at *10. After reviewing Petitioner’s test results, Dr. Konyukhov noted that
Petitioner’s “age might indicate demyelinating disease,” though his MRIs were normal. Id.
Petitioner was diagnosed with “disturbance of skin sensation and left hemiplegia.” Id.
On July 30, Petitioner was admitted to a hospital for further care and observation where
he complained of paresthesia, weakness, tingling, and loss of sensation on the left side of his
body, and difficulty speaking, driving, and walking. O.M.V., 2021 WL 3183719, at *10. While at
the hospital, Petitioner had a neurology consultation with Dr. Syed Munzir, who suspected
Petitioner had a complex migraine and recommended a brain MRI, which came back normal. Id.Petitioner was ultimately diagnosed with “left-sided paresthesia[] and weakness and possible
hemiplegic migraine.” Id. at *10-11. His examining doctor also noted that Petitioner’s etiology
was currently unclear, and he recommended Petitioner abstain from vaccinations until a clear
diagnosis. Id. at *11.
On August 1, 2014, Petitioner saw Dr. Konyukhov. Id. Dr. Konyukhov observed subtle
weakness in Petitioner’s left arm, leg, and intrinsic muscles of hand, as well as some crossing of
the reflexes at the knees. O.M.V., 2021 WL 3183719, at *11. In light of the presence of
oligoclonal bands along with left-sided weakness, Dr. Konyukhov found that Petitioner’s recent
complaint of “right-sided weakness could be [an] indication of [two] different attacks[,]” which
could support a potential diagnosis of multiple sclerosis (“MS”). Id. However, he noted it “[is] so
3
unusual that there is still no lesion present on the MRI.” Id. Dr. Konyukhov recommended
Petitioner undergo an evaluation with an MS specialist. Id.A few weeks later, Petitioner was evaluated by Dr. Jaison Grimes at Indiana University
due to concern for demyelinating illness. O.M.V., 2021 WL 3183719, at *11. After reviewing
Petitioner’s medical history, reported symptoms, and conducting a physical examination, Dr.
Grimes found “[i]t a bit atypical that the patient’s symptoms are so severe without a
corresponding lesion on imagining, but the presence of oligoclonal bands is suggestive that this
could be an atypical presentation of demyelinating disease.” Id. Dr. Grimes recommended
Petitioner “wean his corticosteroids and try an immunomodulating therapy, specifically
Tecfidera.”3 Id. Additional imagining studies were recommended to assess for potential lesions
“to aid in diagnosis of [MS.]” Id. On August 30, 2014, Petitioner underwent MRIs of the lumbar,
cervical, and thoracic spine. Id. No lesions characteristic of MS were reported. Id. at *12.
Petitioner saw Dr. Molina on December 10, 2014, and he reported continued left-sided
weakness, as well as a new onset of right-sided weakness. O.M.V., 2021 WL 3183719, at *12.
Upon examination, Dr. Molina diagnosed Petitioner with left-sided weakness, history of TIA,
hyperlipidemia, and a Vitamin D deficiency. Id. Dr. Molina also provided a letter advising that
Petitioner avoid future flu vaccines because he “had a severe reaction to the flu vaccine
previously which resulted in long-lasting neurological deficits.” Id. at *13.
In January 2015, Petitioner was evaluated by rheumatologist Dr. Heather Gillespie to
assist with his diagnosis. O.M.V., 2021 WL 3183719, at *13. Dr. Gillespie’s assessment found
weakness and pain in the face, upper extremity, and lower extremity, among other ailments. Id.She recommended intermittent steroid dosing and a follow up with Dr. Grimes. Id.Petitioner followed up with Dr. Grimes on February 5, 2015. O.M.V., 2021 WL 3183719,
at *13. Upon a physical examination and review of prior MRIs, Dr. Grimes concluded that
Petitioner did not meet the criteria for MS, but, if Petitioner did meet the criteria, “it would likely
be a progressive form.” Id. Nonetheless, he recommended Petitioner see a neuromuscular
specialist. Id.Petitioner followed up with Dr. Gillespie on March 20, 2015, and she observed the same
symptoms from Petitioner’s prior visit except “now with features of myopathy and labs
consistent with myopathy.” O.M.V., 2021 WL 3183719, at *13. Dr. Gillespie ordered a muscle
biopsy and MRI of the left lower extremity, both of which came back normal. Id. In April 2015,
Petitioner had an electromyography (“EMG”) study of the left arm and leg, which was also
normal. Id. Petitioner returned to Dr. Gillespie on May 6 with complaints of persistent hip
weakness, dorsiflexion weakness, persistent intermittent facial asymmetry, slower thought
process, and drowsiness. Id. at *14. Dr. Gillespie agreed with Petitioner’s continued use of
prednisone and recommended additional labs and a muscle biopsy. Id. Petitioner next saw Dr.
Gillespie on June 10, 2015, and, while he indicated his cognitive symptoms had improved, he
3
Tecfidera is a drug used to treat MS patients. Id. at *11 n.35.
4
reported the weakness and pain on his left side persisted. Id. Petitioner’s muscle biopsy showed
no evidence of inflammatory changes, and Dr. Gillespie believed Petitioner had a “primary
neurologic process.” Id.
Near the end of October 2015, Petitioner saw Dr. Molina for a follow-up after an
emergency room visit. O.M.V., 2021 WL 3183719, at *14. Petitioner reported recurrent episodes
of muscle pain and weakness, and indicated that he was taking Tecfidera for presumed MS, even
though Dr. Grimes did not think Petitioner’s symptoms were due to MS. Id.On February 11, 2016, Petitioner returned to Dr. Gillespie reporting he started treatment
for MS in the past six months with “some benefits.” O.M.V., 2021 WL 3183719, at *14. He
reported an episode of upper extremity weakness, which improved with steroids. Id. He also
complained of joint pain in his hands and chronic neck pain, which Dr. Gillespie attributed to an
“[a]pparent response to MS treatment.” Id.Petitioner returned to Dr. Konyukhov on October 20, 2016 for “possible MS follow up.”
O.M.V., 2021 WL 3183719, at *15. Petitioner reported his history of intermittent episodes of
weakness, numbness, and tingling, mostly on the left side, which he “originally attributed to the
[flu] vaccine.” Id. Dr. Konyukhov noted that Petitioner’s repeat MRIs did not show any
abnormalities, and further noted that Dr. Grimes “considered [the] possibility of [MS] even
without any lesions and therefore placed [Petitioner] on Tecfidera.” Id. Dr. Konyukhov reviewed
the imaging from September 2016 and did not see any nonspecific white matter lesions. Id.Petitioner’s neurological exam was normal except for mild decreased strength in his left arm and
leg. Id. In his assessment, Dr. Konyukhov wrote Petitioner’s “intermittent episodes of weakness
and numbness . . . could be suggestive of some kind of problem in the brain (MS), but so far
MRIs [are] not showing any clear lesions.” Id. He recommended Petitioner continue taking
Tecfidera and have a repeat MRI in one year. Id.In 2017, Petitioner was evaluated on numerous occasions in the emergency room for
difficulty swallowing—which was thought to be due to an allergic reaction. O.M.V., 2021 WL
3183719, at *15. In August 2017, Petitioner was referred to an allergist for allergy testing, and
his test came back negative for everything except histamine. Id.Petitioner returned to Dr. Molina on September 18, 2017 to report his recent difficulty
swallowing and corresponding negative allergy test. O.M.V., 2021 WL 3183719, at *15. Dr.
Molina conducted a neurologic exam, which revealed “[m]ildly decreased grip strength in left
hand [and] mildly decreased flexor strength in legs bilaterally[.]” Id. Her diagnoses included MS
and dysphagia. Id. She ordered MRIs and labs, referred Petitioner to speech therapy and
gastroenterology, and refilled his Tecfidera prescription. Id. Later that month, Petitioner
underwent cervical, brain, and thoracic MRIs, and his brain MRI revealed small, faint FLAIR
hyperintense foci in the white matter, with minimal changes from the previous exam. Id.On October 10, 2017, Petitioner returned to Dr. Gillespie reporting an MS flare up,
persistent weakness in the hands, and worsening difficulty with swallowing. O.M.V., 2021 WL
5
3183719, at *16. Dr. Gillespie recommended Petitioner follow up with neurology for an
“[a]pparent MS variant.” Id. For the remainder of 2017, Petitioner continued to take the MS
drug, Tecfidera, until he tested positive for John Cunningham (“JC”) virus, at which time he was
taken off Tecfidera. Id.Petitioner saw John Emmett, a physician assistant to Dr. Grimes, for a follow-up on
October 16, 2017. O.M.V., 2021 WL 3183719, at *16. Mr. Emmett noted the “few nonspecific
punctuate white matter hyperintensities” on Petitioner’s September 2017 MRI that were
unchanged from Petitioner’s last MRI. Id. Petitioner’s physical exam revealed no neurologic
findings. Id. Mr. Emmett observed that Dr. Grimes had not previously suspected MS “given [the]
lack of exam findings and relative lack of atypical MRI changes.” Id.During 2018 and 2019, Petitioner’s condition remained unchanged, and he continued to
receive conflicting diagnoses. O.M.V., 2021 WL 3183719, at *16-17. On January 22, 2019,
Petitioner returned to Dr. Konyukhov, who noted that there was “[n]o obvious diagnosis [so] far
despite seeing multiple different physicians.” Id. at *17. The next day, however, Petitioner saw
Dr. Molina, who diagnosed Petitioner with “hyperlipidemia, MS, muscle spasm, Vitamin D
deficiency, osteoporosis of lumbar spine, and ‘[a]dverse reaction to [flu] vaccine, sequela.’” Id.
B. Special Master’s Decision
On November 14, 2016, Petitioner filed his petition requesting compensation under the
Vaccine Act alleging that he suffered from permanent disabilities and permanent neurological
deficits resulting from the flu vaccine. See Pet., ECF No. 1. Following numerous submissions of
medical records and expert reports, a two-day entitlement hearing began on November 5, 2020.
See ECF No. 74. During the hearing, Petitioner testified, Dr. Marcel Kinsbourne and Dr. M. Eric
Gershwin also testified for Petitioner, and Dr. Subramaniam Sriram testified on behalf of
Respondent. See O.M.V., 2021 WL 3183719, at *32-38. Petitioner also submitted four expert
reports authored by Dr. Kinsbourne, and two expert reports authored by Dr. Gershwin. See id. at
*20 n.41 & *27 n.57. Respondent filed three expert reports authored by Dr. Sriram. See id. at
*32 n.74.
After consideration of the facts and arguments, the Special Master found that Petitioner
had not established by preponderant evidence that the vaccine caused his condition. O.M.V.,
2021 WL 3183719, at *49. The Special Master concluded that, while there was not preponderant
evidence that Petitioner suffered from acute disseminate encephalomyelitis (“ADEM”) or MS,
Petitioner had “alleged that he suffered a demyelinating neurological condition of the CNS.” Id.
at *43. The Special Master then engaged in the Althen prong analysis, where she found Petitioner
failed to meet his burden under each prong. Id. at *35-39. As a result, the Special Master denied
Petitioner’s request for compensation. Petitioner now seeks review of the Special Master’s
determination.
6
II. STANDARD OF REVIEW
This Court has jurisdiction under the Vaccine Act to review a special master’s decision.
42 U.S.C. § 300aa-12(e)(2). In reviewing a special master’s decision, this Court may:
(A) uphold the findings of fact and conclusions of law of the special master and
sustain the special master’s decision, (B) set aside any of the findings of fact or
conclusions of law of the special master found to be arbitrary, capricious, and 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)(A)-(C).
This Court reviews a special master’s findings of fact 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. Turner v. Sec’y of Health & Hum.
Servs., 268 F.3d 1334, 1337 (Fed. Cir. 2001). The abuse of discretion standard applies to special
master’s evidentiary rulings, including the determinations as to the qualification of experts and
the admissibility of their testimony. Piscopo v. Sec'y of Health & Hum. Servs., 66 Fed. Cl. 49, 53
(2005) (citing Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999)); see Munn v. Sec’y of
Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992) (“The [abuse of discretion
standard] will rarely come into play except where the special master excludes evidence.”]; Caves
v. Sec'y of Health & Hum. Servs., 100 Fed. Cl. 119, 131 (2011), aff'd, 463 F. App'x 932 (Fed.
Cir. 2012) (“The . . . abuse of discretion [standard] is applicable when the special master
excludes evidence or otherwise limits the record upon which it relies.”). With respect to the
arbitrary and capricious standard, “no uniform definition . . . has emerged,” but it is “a highly
deferential standard of review” such that “[i]f 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.” Hines v. Sec’y of Health & Hum.
Servs., 940 F.2d 1518, 1527-28 (Fed. Cir. 1991). This Court’s role is not to “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.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249
(Fed. Cir. 2011); Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000);
see also Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto Ins. Co., 463 U.S. 29,
43 (1983) (a decision is arbitrary and capricious only if it is “so implausible that it could not be
ascribed to a difference of view”).
III. LEGAL STANDARDS
The Vaccine Act was established to compensate vaccine-related injuries and deaths after
a showing that the vaccine caused the injury suffered. 42 U.S.C. § 300aa-11(a)(5)(B)(10). The
Vaccine Act provides two ways for a petitioner to establish causation. Munn, 970 F.2d at 865. A
petitioner may demonstrate causation through a statutorily prescribed presumption upon a
showing that the alleged injury is one listed in the Vaccine Injury Table (the “Table”). 42 U.S.C.
7
§ 300aa-14. Or, when the alleged injury is not listed—an “off-Table injury”—the petitioner must
prove “causation-in-fact” by a preponderance of the evidence—in other words, that they received
a vaccine listed in the Table and that they suffered an injury as a result of the vaccine. See 42
U.S.C. §§ 300aa-11(c)(1)(C)(ii); Lampe, 219 F.3d at 1360.
In this case, because Petitioner’s alleged injury—a demyelinating illness or other
neurological condition—is not listed on the Table, he does not benefit from a presumption of
causation, and he must specify his vaccine-related injury and shoulder the burden of proof on
causation. Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1356 (Fed. Cir. 2010).
More specifically, under the Althen test, he must:
show by a preponderance of the evidence that the vaccination brought about the
injury by providing: (1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and (3) a showing of a proximate temporal
relationship between vaccination and injury.
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). This three-prong
test “is intended to evaluate whether the vaccine actually caused the injury.” Locane v. Sec’y of
Health and Hum. Servs., 685 F.3d 1375, 1380 (Fed. Cir. 2012). However, before applying the
Althen test, the Vaccine Act requires a petitioner to show by preponderant evidence a “medically
recognized injury” that is “more than just a symptom or manifestation of an unknown injury.”
Lombardi v. Sec’y of Health & Hum. Servs., 656 F.3d 1343, 1352-53 (Fed. Cir. 2011)
(explaining “if the existence and nature of the injury itself is in dispute,” then “identification of a
petitioner’s injury is a prerequisite to an Althen analysis of causation”).
IV. ANALYSIS
Petitioner identifies two perceived errors in the Special Master’s decision. First, he argues
that the Special Master erred by finding Petitioner did not establish that he suffered from a
demyelinating illness or other neurological condition. Pet’r’s Mot. at 17. Second, he argues that
the Special Master “committed reversible error when she found against the weight of the
evidence, that [P]etitioner’s neurological condition could not be caused by an innate immune
response and that he therefore did not meet his burden under Althen prong [one].” Id. at 20. The
Court addresses each of Petitioner’s concerns in turn.
A. Petitioner’s injury
Petitioner asserts that he established by preponderant evidence that he suffered from a
demyelinating condition post-vaccination based on the “overwhelming consensus of
[P]etitioner’s numerous treating physicians and the testimony of the medical experts.” Pet’r’s
Mot. at 17-18. Petitioner’s position is that, while the Special Master’s conclusions that he did not
suffer from ADEM or MS might be justified by the record, the Special Master erred in
concluding that he did not establish that he suffered from any neurological condition at all. Id. at
19. The Special Master’s failure to do so, Petitioner argues, was an abuse of discretion and
warrants reversal. Id. at 19-20. Respondent counters arguing that the Special Master properly
8
determined that Petitioner did not provide preponderant evidence that he suffered from ADEM,
MS, or any other defined neurological condition. Resp’t’s Resp. to Pet’r’s Mot. at 10, ECF No.
131 [hereinafter Resp’t’s Resp.].
An off-Table petitioner—who does not benefit from a presumption of causation—must
specify their vaccine-related injury and shoulder the burden of proving causation. Broekelschen,
618 F.3d at 1346. Identification of a vaccine-related injury is a prerequisite to the Althen
analysis. Id. This is because “[m]edical recognition of the injury claimed is critical and by
definition a ‘vaccine-related,’ i.e., illness, disability, injury, or condition, has to be more than just
a symptom or manifestation of an unknown injury.” Id. at 1349. An exact diagnosis, though, is
not required for the special master to proceed to the Althen causation analysis. See Knudsen v.
Sec’y of Health & Hum. Servs., 35 F.3d 543, 549 (Fed. Cir. 1994) (“[T]o require identification
and proof of specific biological mechanisms would be inconsistent with the purpose and nature
of the vaccine compensation program.”). When there is a dispute as to the nature of the injury, as
in the present case, it is the duty of the special master to determine what injury, if any, is best
supported by the evidence presented in the record before applying the Althen analysis to
determine causation relative to that injury. Broekelschen, 618 F.3d at 1346; Lombardi, 656 F.3d
at 1352 (“[I]f the existence and nature of the injury itself is in dispute, it is the special master’s
duty to first determine which injury was best supported by the evidence presented in the record
before applying the Althen test to determine causation of that injury.”); see also Hibbard v. Sec’y
of Health & Hum. Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012) (finding no error when the
special master first focused on whether the petitioner had the injury she claimed was caused by
the vaccine before addressing causation).
In this case, both parties read the Special Master’s decision as concluding that Petitioner
did not establish by preponderant evidence that he suffered from any neurological condition. See
Pet’r’s Mot. at 17; Resp’t’s Resp. at 7. However, the Court finds that the Special Master
appropriately determined the nature of Petitioner’s alleged injury based on the evidence
presented in the record before proceeding with the Althen causation analysis. See Broekelschen,
618 F.3d at 1346. The parties dispute the nature of Petitioner’s injury. Petitioner’s expert Dr.
Kinsbourne opined that Petitioner’s diagnosis was “an inflammatory autoimmune
encephalopathy that is most like MS with an ADEM-like onset, and with symptoms consistent
with a demyelinating disorder.” O.M.V., 2021 WL 3183719, at *20. Respondent’s expert Dr.
Sriram opined that “the evidence does not support a diagnosis of MS, ADEM, or a demyelinating
condition . . . [and] [P]etitioner’s diagnosis remains ill-defined and unclear.” Id. at *32. Thus, in
a case like this, the Special Master appropriately determined which injury was best supported by
the evidence presented in the record before applying the Althen test. Broekelschen, 618 F.3d at
1346.
The record shows the Special Master thoroughly considered whether Petitioner
established, by preponderant evidence, that he suffered from ADEM, MS, or any other
demyelinating disease. See O.M.V., 2021 WL 3183719, at *40-43. In doing so, the Special
Master first explicitly found Petitioner did not properly satisfy the diagnostic criteria for ADEM
or MS—which Petitioner appears to acknowledge. See Pet’r’s Mot. at 19 (“[W]hile the Special
Master’s conclusions that [P]etitioner did not suffer from ADEM or MS per se might be justified
by the record . . . .”); O.M.V., 2021 WL 3183719, at *40 (finding Petitioner did not suffer from
9
ADEM); id. at *42 (finding no preponderant evidence that Petitioner suffers from MS). The
Special Master then proceeded to further analyze Petitioner’s alleged “miscellaneous
demyelinating or neurological conditions.” Id. at *43. In consideration of Petitioner’s expert
reports and testimony, the Special Master found:
Regardless of the phrase Dr. Kinsbourne use[d] to describe [P]etitioner’s diagnosis,
the totality of Dr. Kinsbourne’s opinions boil[s] down to one category of
neurological conditions—a demyelinating illness of the CNS. Thus, regardless of
the name or phrase used, the undersigned finds that [P]etitioner has alleged that
he suffered a demyelinating neurological condition of the CNS. Further, the
undersigned finds that the petitioner has not established by preponderant evidence
that he suffered a demyelinating illness post-vaccination.
Id. (emphasis added). From this, it is clear that the Special Master determined that Petitioner’s
alleged injury based on the record was a demyelinating neurological condition of the CNS. If the
Special Master had concluded that Petitioner failed to meet his burden of identifying an injury,
the Special Master could have stopped her analysis there. See Hibbard, 698 F.3d at 1364-65 (“If
a special master can determine that a petitioner did not suffer [a vaccine-related injury], there is
no reason why the special master should be required to undertake the separate (and frequently
more difficult) [Althen analysis].”); see also Lombardi, 656 F.3d at 1353 (“In the absence of a
showing of the very existence of any specific injury of which the petitioner complains, the
question of causation is not reached.”); Locane, 685 F.3d at 1381. The Special Master, instead,
appropriately identified “demyelinating neurological condition of the CNS” as the injury—which
aligns with the injury alleged by Petitioner 4—before proceeding with the requisite causation
analysis. 5 The Court also finds that the Special Master’s identification of the Petitioner’s alleged
injury based on the record evidence was not arbitrary or capricious, an abuse of discretion, or
otherwise not in accordance with law.
The confusion appears to arise from the following sentence in the Special Master’s
decision: “Further, the undersigned finds that the petitioner has not established by preponderant
evidence that he suffered a demyelinating illness post-vaccination.” O.M.V., 2021 WL 3183719,
at *43. This sentence may arguably be interpreted to mean that the Special Master determined
that Petitioner failed to establish that he suffered from any demyelinating condition. However,
the Court interprets this sentence to mean, not that Petitioner failed to demonstrate that he
suffered from any neurological condition at all, but that Petitioner had not demonstrated that his
neurological condition was caused by the vaccination. See id. (finding Petitioner failed to
establish by preponderant evidence that he suffered a demyelinating illness post-vaccination).
4
In his motion, Petitioner argues that by a showing of preponderant evidence his alleged vaccine-related injury
encompasses “a neurological illness, likely demyelinating in nature[,]” “neurological condition[,]” or “any CNS
demyelinating condition.” Pet’r’s Mot. at 17, 19.
5
This conclusion is further supported by the Special Master’s elimination of “a number of other non-demyelinating
conditions, including stroke (CVA), hemiplegic migraine, and CNS vasculitis” referenced within Petitioner’s post-
vaccination medical records. O.M.V., 2021 WL 3183719, at *43. Because Petitioner “ha[d] not alleged, nor ha[d] his
experts opined, that his alleged vaccine-related diagnosis [was] stroke, hemiplegic migraine, or vasculitis,” she
concluded that there was “insufficient evidence of any other neurological condition or diagnosis to support
[P]etitioner’s claim for compensation.” Id. (emphasis added).
10
The inclusion of “post-vaccination” to qualify the remainder of the sentence speaks more to
causation and serves as a preview of the Special Master’s analysis under the Althen prongs.
B. Althen Prong One
Petitioner also asserts that the Special Master committed reversible error when she found
against the weight of the evidence that Petitioner’s neurological condition could not be caused by
an innate immune response, and therefore concluded Petitioner failed to satisfy his burden under
Althen prong one. Pet’r’s Mot. at 20. Specifically, Petitioner argues the Special Master failed to
acknowledge or explain why the role of the adaptive immune system rules out the ability of the
innate immune system to produce neurological symptoms[] and ignore[d] petitioners’ [sic]
experts’ cogent and reliable explanation of how it can do so, and within the time frame
experienced by [Petitioner].” Id. at 21-22.
Under the first Althen prong, a petitioner must show by preponderant evidence a medical
theory causally connecting the vaccine received and the injury sustained. Althen, 418 F.3d at
1278; see Hibbard, 698 F.3d at 1365 (requiring petitioner to show both the medical plausibility
of their theory of causation and that the injury was consistent with that theory); Pafford v. Sec’y
of Health & Hum. Servs., 451 F.3d 1352, 1355-56 (Fed. Cir. 2006) (stating that the first Althen
prong requires petitioner to show that the received vaccine caused the alleged injury).
Petitioner’s medical theory need not be medically or scientifically certain, but it must be a
“sound and reliable” medical or scientific explanation. Boatmon v. Sec’y of Health & Hum.
Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019) (citing Knudsen, 35 F.3d at 548-49).
The Federal Circuit has made clear that special masters, as the finders of fact, have the
responsibility to weigh the persuasiveness and reliability of evidence presented to them, and if
appropriate, the credibility of testimony. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d
1315, 1325 (Fed. Cir. 2010); see Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316
(Fed. Cir. 1999) (“[T]he rules of evidence require that the trial judge determine whether the
testimony has a reliable basis in the knowledge and experience of [the relevant] discipline.”)
(internal quotation marks omitted). The special master has broad discretion in determining the
credibility of witnesses and weighing the evidence, and these credibility determinations are
“virtually unreviewable” by the reviewing court. Bradley v. Sec’y of Health & Hum. Servs., 991
F.2d 1570, 1575 (Fed. Cir. 1993). The reviewing court does not reweigh the evidence, assess
whether the special master correctly evaluated the evidence, or examine the probative value of
the evidence or the credibility of the witnesses because all of these matters are within the
purview of the factfinder. Broekelschen, 618 F.3d at 1349.
The record shows that the Special Master appropriately evaluated and weighed the
evidence to reach the conclusion that Petitioner had not offered a sound and reliable medical
theory causally connecting the flu vaccine to a demyelinating CNS illness. O.M.V., 2021 WL
3183719, at *43. Based on the evidence, she determined that the prevailing mechanism causally
associated with a demyelinating CNS illness is a T cell mediated adaptive immune system
response, not an innate immune response. Id. The Special Master explained that, based on her
experience, current medical literature, and expert testimony, molecular mimicry (an adaptive
11
immune system response) is the prevailing mechanism implicated in CNS demyelinating
conditions. Id.The Special Master properly assessed and considered the expert testimony presented by
the parties. An assessment of the reliability of expert testimony is a determination that special
masters are entitled—and expected—to make. Porter, 663 F.2d at 1250-51 (“[The Federal
Circuit] has unambiguously explained that special masters are expected to consider the
credibility of expert witnesses in evaluating petitions for compensation under the Vaccine Act.”);
Bradley, 991 F.2d at 1575 (stating the factfinder has broad discretion in determining credibility
because they see the witnesses and hear testimony). The Special Master’s decision discusses Dr.
Kinsbourne’s testimony and notes that, while he opined that “vaccinations [generally] can cause
demyelinating disorders . . . [he] deferred to Dr. Gershwin as to the mechanism.” O.M.V., 2021
WL 3183719, at *22. She further highlighted the fact that “Dr. Kinsbourne expressly rejected the
mechanism of molecular mimicry in this case and opined that molecular mimicry would not
occur within 24 hours.” Id. at *23. The Special Master also addressed Dr. Gershwin’s opinion of
how the innate immune system can give rise to inflammation in the brain within twenty-four
hours but considered it unpersuasive. Id. at *28-30. She found “Dr. Gershwin made a compelling
argument that cytokines play a role in the pathological process of ADEM and MS[,]” but
ultimately determined “[P]etitioner did not provide sound and reliable evidence that the innate
immune system cytokine-induced inflammation explains CNS demyelination.” Id. at *44-45.
The Special Master explained the evidence supported the conclusion that “[i]t is the adaptive
immune response that conducts the orchestra of various instruments that together play a role to
cause CNS demyelination.”6 Id. (citing supporting sources).
Furthermore, the Special Master explained that she found Respondent’s expert witness
testimony by Dr. Sriram more persuasive because it was consistent with her experience, the
medical literature, and prevailing case law. O.M.V., 2021 WL 3183719, at *45. Specifically, Dr.
Sriram testified that vaccination activates antigens in the lymph nodes where T cells proliferate,
amplify, and subsequently enter the brain, which implicates an adaptive immune response. Id.The Federal Circuit has made clear that the special master’s evaluation of the evidence—
including its reliability and persuasiveness—is a “matter within the purview of the fact finder[,]”
not the reviewing court. Lampe, 219 F.3d at 1364; see Doe v. Sec’y of Health & Hum. Servs.,
601 F.2d 1349, 1355 (Fed. Cir. 2010). Petitioner has not demonstrated that the Special Master
erred. Most, if not all, of Petitioner’s assertions relate to the weight assigned to certain evidence
before the Special Master, and such factual findings are not to be second guessed by the Court.
Lampe, 219 F.3d at 1362; Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir.
1993) (expressing the Vaccine Act “makes clear” that the reviewing court’s purpose “is not to
second guess” a special master’s fact-intensive conclusions); see Munn, 970 F.2d at 870 (“It is,
after all, the special masters to whom Congress has accorded the status of expert, entitling them
to the special statutory deference in fact-finding normally reserved for specialized agencies.”).
6
The Special Master further noted that the medical literature supporting a finding of cytokines in clinically definite
MS patients did not address whether cytokines caused or initiated the demyelinating disease. O.M.V., 2021 WL
3183719, at *44 n.86.
12
In addition to weighing the evidence presented at the entitlement hearing, the Special
Master agreed with the reasoning in prior vaccine cases where special masters rejected the theory
of innate immunity as a sound and reliable mechanism in CNS demyelinating conditions. See
O.M.V., 2021 WL 3183719, at *43-44. The Court acknowledges that a special master may not
exclusively rely on the fact-findings of other related vaccine cases to come to an ultimate
determination. See Contreras v. Sec’y of Health & Hum. Servs., 107 Fed. Cl. 280, 308 (2012).
But that is not the case here. The Special Master’s analysis was not “limited to a conclusory
statement[,]” as Petitioner contends, rather the Special Master considered prior vaccine cases as
lending additional support to the evidence before her. See O.M.V., 2021 WL 3183719, at *43-45.
The record shows that the Special Master relied on medical literature and expert testimony, in
conjunction with her experience and case law, in coming to her conclusion that Petitioner in this
case did “not offer a sound and reliable medical theory in support of his claim.” Id. at *46; see,
e.g., Nunez v. Sec’y of Health & Hum. Servs., 144 Fed. Cl. 540, 548 (2019) (finding the special
master appropriately reviewed the record as a whole and considered a similar vaccine case
because she articulated a rational basis for her decision to reject petitioner’s medical theory).
In sum, the record demonstrates that the Special Master appropriately analyzed the
evidence, including Petitioner’s experts, in determining whether an innate immune system can
cause inflammation within twenty-four hours. After weighing the evidence and testimony, the
Special Master rejected Petitioner’s “novel theory” of innate immunity as a reliable mechanism
in CNS demyelinating conditions. See Lampe, 219 F.3d at 1362 (noting the special master’s
assessment of witness credibility and their relative persuasiveness of competing medical theories
are “uniquely deferential” and “virtually unchallengeable on appeal”). The Court finds that this
conclusion was not arbitrary or capricious. Petitioner directs the Court to various points in the
transcript that present evidence that “the flu vaccine can cause inflammation in the brain within
24 hours and that inflammation can occur independent of any T cell activation associated with an
adaptive immune response.” See Pet’r’s Mot. at 22-23. The Court, however, declines Petitioner’s
invitation to reweigh evidence before the Special Master. See Broekelschen, 618 F.3d at 1349.
This Court’s role in reviewing the special master’s decision “is not to second guess the [s]pecial
[m]aster’s fact-intensive conclusions[.]” Locane, 685 F.3d at 1380. 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. Hines, 940 F.2d
at 1528. The record shows the Special Master considered all the evidence and, based on the
evidence before her, concluded that Petitioner did not provide a “reliable medical or scientific
explanation” sufficient to prove by preponderant evidence a medical theory linking the flu
vaccine to his injury. O.M.V., 2021 WL 3183719, at *43.
C. Remaining Althen prongs
Petitioner does not directly challenge the Special Master’s findings under the remaining
Althen prongs. Instead, he argues that the Special Master’s “flawed reasoning rejecting that
petitioner had a CNS demyelinating condition, or any neurological condition whatsoever, tainted
her subsequent analysis.” See Pet’r’s Mot. at 20. Respondent argues that Petitioner challenges the
Special Master’s findings only under the first Althen prong, but his failure to meet his burden
under the remaining Althen prongs is just as fatal. Resp’t’s Resp. at 12.
13
The Court is not persuaded by Petitioner’s argument that the Special Master’s analysis
under the Althen prongs was “tainted” by a failure to find that Petitioner suffered a neurological
condition and her further finding that such condition was not causally connected to his vaccine
under the first Althen prong. As explained above, the Special Master’s decision shows that she
did in fact find that Petitioner had alleged that he suffered from a neurological condition—
specifically a demyelinating illness of the CNS. The Special Master then proceeded to analyze
such injury under the Althen prongs.
With respect to her analysis under the Althen prongs, the Court has reviewed the Special
Master’s decision under the first prong and, as discussed above, determined that her conclusions
were not arbitrary or capricious, an abuse of discretion, or otherwise not in accordance with law.
Petitioner does not provide any support for his argument that the Special Master’s analysis on the
second and third Althen prongs was arbitrary or capricious, aside from a conclusory statement
that it was “tainted” by earlier findings. Because Petitioner failed to meet his burden of proof
under the first Althen prong, he is not entitled to compensation under the Vaccine Act. See
Broekelschen, 618 F.3d at 1350 (expressing that the Vaccine Act requires a petitioner to prove
each prong of the Althen test by a preponderance of the evidence); see also DePena v. Sec’y of
Health & Hum. Serv., 133 Fed. Cl. 535, 549 (2017) (“[A] petitioner must satisfy all three prongs
of the Althen test; a failure to satisfy one prong is fatal to the case.”); Doe/11 ex rel.
Child/Doe/11 v. Sec'y of Dep't of Health & Hum. Servs., 87 Fed. Cl. 1, 14 (2009), aff'd sub nom.
Doe v. Sec'y of Health & Hum. Servs., 601 F.3d 1349 (Fed. Cir. 2010) (“Failure to satisfy any of
the three prongs prevents [p]etitioners from making their prima facie showing.”). Thus, under
these circumstances, the Court does not conduct a review of the Special Master’s analysis and
conclusions under the remaining Althen prongs.
V. CONCLUSION
In the conclusion of the Special Master’s decision, she stated “[i]t is clear that [P]etitioner
has had a very difficult struggle with his health since November 2013, and the undersigned
extends her sympathy.” The Court likewise acknowledges Petitioner’s suffering and extends
sympathy. However, because Petitioner has not demonstrated that the Special Master’s decision
was arbitrary or capricious, an abuse of discretion, or otherwise not in accordance with law, this
Court must sustain the Special Master’s decision.
For the reasons stated above, Petitioner’s motion for review of the Special Master’s
decision is DENIED, and the Special Master’s decision of June 26, 2021 is SUSTAINED. The
Clerk of the Court is DIRECTED to enter judgment accordingly.
IT IS SO ORDERED.
s/ Thompson M. Dietz
THOMPSON M. DIETZ, Judge
14