Singleton v. Secretary of Health and Human Services ( 2023 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1474V
Filed: April 28, 2023
PUBLISHED
Special Master Horner
LUCITA SINGLETON,
Petitioner, Influenza (“Flu”) vaccine;
v. subclinical seizures; epilepsy;
significant aggravation.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Renee J. Gentry, Vaccine Injury Clinic, George Washington University Law School
Washington, DC, for petitioner.
Zoe Wade, U.S. Department of Justice, Washington, DC, for respondent.
DECISION 1
On October 10, 2017, Lucita Singleton (“petitioner”) filed a petition for
compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. §300aa-10-
34 (2018). 2 (ECF No. 1.) Petitioner alleges that the influenza (“flu”) vaccination that
she received on October 21, 2014, caused her subclinical seizures and epilepsy. Id.
For the reasons set forth below I conclude that petitioner is not entitled to an award of
compensation.
1 Because this decision contains a reasoned explanation for the action taken in this case, it must be made
publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-
10-34.
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I. Applicable Statutory Scheme
Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period also specified in the Table. If so, causation is presumed and the
petitioner is automatically entitled to compensation, unless it is affirmatively shown that
the injury was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A);
§ 300 aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
In many cases, however, the vaccine recipient may have suffered an injury not of
the type covered in the Vaccine Injury Table. In these cases, the presumptions
available under the Vaccine Injury Table are inoperative. Instead, the petitioner bears
the burden of showing by preponderant evidence that the vaccine recipient’s injury was
actually caused by the alleged vaccination, often referred to as “causation-in-fact”.
§ 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii); see also Althen v. Sec’y of Health &
Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health &
Human Servs., 940 F.2d 1518, 1525 (Fed. Cir. 1991).
To show actual causation, petitioner must satisfy the “preponderance of the
evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-
13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that
standard, the petitioner must show that it is “more probable than not” that the
vaccination caused the alleged injury. Althen, 418 F.3d at 1279. The petitioner need
not show that the vaccination was the sole cause of the injury or condition, but must
demonstrate that the vaccination was a “substantial factor” and a “but for” cause.
Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999).
This standard has been interpreted to require “proof of a logical sequence of cause and
effect showing that the vaccination was the reason for the injury;” the logical sequence
must be supported by “reputable medical or scientific explanation, i.e., evidence in the
form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant
v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). A petitioner
may not receive a Vaccine Program award based solely on his or her assertions; rather,
the petition must be supported by either medical records or by the opinion of a
competent physician. § 300aa-13(a)(1).
In what has become the predominant framing of this burden of proof, the Althen
court described the “causation-in-fact” standard, as follows:
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Concisely stated, Althen’s burden is to show by preponderant evidence that
the vaccination brought about her 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 proximate temporal relationship between
vaccination and injury. If Althen satisfies this burden, she is “entitled to
recover unless the [government] shows, also by a preponderance of the
evidence, that the injury was in fact caused by factors unrelated to the
vaccine.”
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner
need not necessarily supply evidence from medical literature supporting petitioner’s
causation contention, so long as the petitioner supplies the medical opinion of an
expert. Id. at 1279-80. That expert’s opinion must be “sound and reliable.” Boatmon v.
Sec’y of Health & Human Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019). The Althen
court also indicated, however, that a Program fact finder may rely upon “circumstantial
evidence,” which the court found to be consistent with the “system created by Congress,
in which close calls regarding causation are resolved in favor of injured claimants.”
Althen, 418 F.3d at 1280.
A petitioner may also allege that a vaccine caused a “significant aggravation” of a
pre-existing condition. The Vaccine Act defines a significant aggravation as any change
for the worse in a pre-existing condition which results in markedly greater disability,
pain, or illness accompanied by substantial deterioration of health. § 300aa-33(4).
Where a petitioner in an off-Table case is seeking to prove that a vaccination
aggravated a pre-existing injury, petitioners must also establish three additional factors.
See Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (Fed. Cl. 2009)
(combining the first three Whitecotton factors for claims regarding aggravation of a
Table injury with the three Althen factors for off table injury claims to create a six-part
test for off-Table aggravation claims); see also W.C. v. Sec’y of Health & Human Servs.,
704 F.3d 1352, 1357 (Fed. Cir. 2013) (applying the six-part Loving test.). The additional
Loving factors require petitioners to demonstrate aggravation by showing: (1) the
vaccinee’s condition prior to the administration of the vaccine, (2) the vaccinee’s current
condition, and (3) whether the vaccinee’s current condition constitutes a “significant
aggravation” of the condition prior to the vaccination. W.C., 704 F.3d at 1357.
II. Issues to be Decided
In this case, petitioner initially alleged in her petition that her flu vaccine caused
her to suffer subclinical seizures and epilepsy. (ECF No. 1.) After the exchange of
expert opinions, petitioner refined her contentions in her prehearing brief. She contends
that she “was vascularly compromised prior to her influenza vaccination and, as such,
must demonstrate significant aggravation” under the six-part Loving test. (ECF No. 56,
p. 10.) Specifically, petitioner characterizes her burden as follows:
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(1) She must demonstrate that she had preexisting asymptomatic
microvascular angiopathy (2) that ultimately evolved into Epilepsy (3) which
is clearly a significant aggravation of her preexisting condition under the
Loving/Sharpe criteria. Then she must show (4) a medical theory causally
connecting the influenza vaccine with microvascular angiopathy, that theory
must be reputable and based on reliable science, (5) a logical sequence of
cause and effect between the influenza vaccine and her symptoms, that is,
that her clinical picture fits the theory proposed, and (6) an appropriate
temporal relationship between the influenza vaccine and the onset of her
symptoms. In totality, Ms. Singleton needs to make a showing of these six
prongs by a simple preponderance of the evidence, however the 4th Loving
prong, i.e., the 1st Althen prong, need only be demonstrated to be
biologically plausible.
(Id. at 11.)
For his part, respondent initially addresses this case in the context of the three-
part Althen test, but also filed a reply addressing petitioner’s contentions under the
Loving test. (ECF Nos. 60, 61.) He contests petitioner’s characterization of the burden
of proof under Althen prong one. (ECF No. 60.) Respondent also asserts that,
assuming arguendo petitioner had met her prima facie burden of proof, then petitioner’s
epilepsy would still be more likely to have been caused by a factor unrelated to
vaccination, namely a viral infection diagnosed shortly after vaccination. (Id. at 25-26.)
In the interest of completeness, the analysis below will address the full six-part
Loving test advocated by petitioner, though the analysis conducted pursuant to the
overlapping Loving and Althen prongs (i.e., Loving prongs four through six/Althen
prongs one through three) is substantially the same and dispositive under either type of
analysis. Because petitioner has not met her burden of proof, it is not necessary to
determine whether respondent has demonstrated petitioner’s diagnosed viral syndrome
as an alternative cause of her condition.
III. Procedural History
This case was originally assigned to Special Master Millman on October 10,
2017. (ECF No. 4.) Following an initial order issued on October 19, 2017, petitioner
filed a series of medical records on October 25, and a statement of completion on
November 29, 2017. (ECF Nos. 6-9.) Respondent subsequently filed his Rule 4(c)
report recommending against compensation on August 7, 2018. (ECF No. 16.) In
response, petitioner filed an expert report from Dr. Carlo Tornatore on January 22,
2019, and the accompanying medical literature on March 28, 2019. (ECF Nos. 20, 24.)
On June 4, 2019, this case was reassigned to my docket. (ECF No. 27.)
Respondent filed a responsive expert report and medical literature from Dr. M.
Steven Evans on August 16, 2019. (ECF No. 34.) Petitioner then filed a supplemental
report from Dr. Tornatore on March 2, 2020. (ECF No. 41.) On April 7, 2020,
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respondent filed his own supplemental expert report from Dr. Evans. (ECF No. 42.) On
April 8, 2020, the parties filed a joint status report indicating that they believed this case
was ripe for an entitlement hearing. (ECF No. 43.) On October 20, 2020, a two-day
entitlement hearing was scheduled to commence on June 21, 2022. (ECF No. 45.) In
the interim, petitioner filed additional medical records, medical literature, and an affidavit
describing her condition. (ECF Nos. 46-49, 53, 57.) A prehearing order setting a
briefing schedule and close of the record was issued on April 5, 2022. (ECF No. 50.)
The parties filed their prehearing briefs on May 31, 2022. (ECF Nos. 56, 60.)
Respondent filed a reply brief on June 7, 2022. (ECF No. 61.) A two-day entitlement
hearing was held on June 21, 2022. (See ECF No. 65, Transcript of Proceedings (“Tr”),
filed 07/07/2022.) Respondent filed additional medical literature on June 22, 2022.
(ECF No. 63; Ex. FF.) On July 7, 2022, petitioner filed a status report confirming she
“d[id] not wish to file a written response to Respondent’s exhibit FF.” (ECF No. 66.)
This case is now ripe for a decision on entitlement.
IV. Factual History
a. As reflected in the medical records
Prior to her vaccination, petitioner showed no signs or symptoms of central
nervous system disorder or neurologic or cognitive dysfunction. (See Ex. 4, p. 3 (noting
no neurologic symptoms).) Petitioner’s earliest record from February 17, 2012,
documents a history of hypertension, anemia, and seasonal allergies. (Id.; Ex. 11, pp.
2-4, 33-34.) Based on her medical records, it appears that petitioner’s upper respiratory
symptoms were primarily the result of environmental allergies and only occasionally a
viral infection. (Ex. 11, pp. 2-5, 33.) In addition to these physical health issues,
petitioner also suffered from mild depression triggered by the passing of her sister and
cousin (as evidenced in her mental health assessments). (Ex. 5, pp. 2-13.) On
September 18, 2014, petitioner presented for a psychotherapy session wherein she
reported an instance of crying at work and also described “cloudy thoughts” and “not
being able to get it together.” (Id. at 23.)
Petitioner received the flu vaccination at issue in this case on October 21, 2014.
(Ex. 1, p. 1.) On October 27, 2014, she reported to the Community Clinic of Shelbyville
& Bedford County (“Community Clinic”) for an examination. (Ex. 6, p. 2.) During this
visit, petitioner reported that she received the flu shot “at 2:30 [and] got sick at
5:30 . . . .” (Id.) Petitioner reported that she lost her appetite, could not think, had no
energy, and had been sleeping a lot. (Id.) Petitioner’s symptoms had reportedly lasted
for six days and were becoming progressively worse. (Id.) She reported that she
received a flu shot the year prior with no problems. (Id.) She was diagnosed with a viral
syndrome “with complications,” and treated with Biaxin, ibuprofen, fluids, and rest. (Id.)
Petitioner had a follow up for her viral syndrome on November 3, 2014, where
she reported feeling better but noted that her appetite had not returned and that her
energy level remained low. (Ex. 6, p. 4.) Augmentin and “flu vaccine?” were listed
under allergies. (Id.) On November 17, 2014, petitioner returned for further follow up
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on her condition and reported that she felt “much better” and was ready to resume
working. (Id. at 3.) Petitioner continued to report memory issues and fatigue. (Id.) She
was diagnosed with viral syndrome and recommended continued fluids and rest when
needed. (Id.) Petitioner was seen again for further therapy and counseling of her
depression on November 24, 2014, where she reported that after she received the flu
vaccine she felt “so bad [she] thought [she] was going to die at one point.” (Ex. 5, p.
25.)
More than six months later, on June 27, 2015, petitioner reported to Saint
Thomas health for dental, blood pressure medication, and vision issues. (Ex. 7, p.2.)
Petitioner’s review of symptoms included fever and memory loss. (Id. at 3.) Petitioner
was also seen for complaints of “memory impairment” at Saint Louise clinic by Social
Worker Tiffany Thomas, Nurse Practitioner Cassandra Gladkowski, and Dr. Jessica
Thomas. (Ex. 9, pp. 1-4.) Petitioner’s medications included hydrochlorothiazide, iron,
and metoprolol. (Id. at 1.) She reported that after receiving the flu shot in October of
2014, she did not “feel right” and developed fever and chills which worsened over
several days. (Id. at 4.) Petitioner described “an explosion of colors,” but denied any
headaches. (Id.) She reported feeling “normal” approximately 3-4 months after her
vaccination, though she still suffered from short term memory loss. Petitioner denied
loss of memory of personal information, falling, and recent visual changes, but reported
that she was “not as strong as [she] used to be.” (Id.) On examination, she showed “no
gross deficit of memory...but slightly abnormal neuro exam noted today.” (Ex. 9, p. 5.)
Petitioner had positive Romberg and nystagmus tests. 3 (Id.) Dr. Gladkowski did not
feel a CT scan was necessary, but petitioner was referred to neurology with a history of
“systemic symptoms with short term memory loss x 1 year.” (Id.) Petitioner’s labs
showed elevated folate and glucose levels but were otherwise within normal ranges.
(Id. at 10-12.)
Petitioner returned to Dr. Thomas on August 14, 2015, for a follow up on her
memory problems. (Ex. 12, pp. 14–15.) Petitioner further explained her post-vaccine
condition, noting that she received her vaccination on a Tuesday, and that by Thursday
she would forget how she arrived at her place of employment. (Id. at 15.) She
explained that she began “seeing expulsions [sic]” after taking Nyquil during the days
after her vaccination and that at the time of this exam she had been experiencing
episodes of hand spasms, described by Dr. Thomas as “draw[ing] up.” (Id.) Petitioner
did not report any gross deficits of memory or abnormal behavior like placing her keys in
the freezer, but explained that she would forget to turn the water off and that she could
not use the stove. (Id.) Petitioner’s physical exam did not reveal any new issues. (Id.
3 Romberg sign refers to “swaying of the body or falling when standing with the feet close together and
the eyes closed; the result of loss of joint position sense, seen in tabes dorsalis and other diseases
affecting the posterior columns.” Romberg sign, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=106448 (last accessed Mar. 6, 2023). A
Nystagmus test, also called a Barany or caloric test, is conducted for ocular and vestibular functioning—
"irrigation of the normal ear with warm water produces rotatory nystagmus (caloric nystagmus) toward the
irrigated side; irrigation with cold water produces similar nystagmus away from that side.” Caloric test,
DORLAND’S MEDICAL DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=112479
(last accessed Mar. 6, 2023).
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at 16–17.) Dr. Thomas believed that petitioner may have experienced hypertensive
urgency and “maybe [posterior reversible encephalopathy syndrome],” (“PRES”). (Id. at
17.) Dr. Thomas was concerned that petitioner “had a stroke or seizures that should
now be treated.” (Ex. 12, p. 17.) Dr. Thomas prescribed vitamin D, additional blood
tests, an EEG, and a brain MRI. (Id.) Petitioner’s brain MRI was conducted on August
20, 2015, revealing no restricted diffusion, “[v]ery mild periventricular increased flair
signal,” suggesting “minimal periventricular demyelinization [sic] likely from chronic
small vessel [ischemic] disease, [and] chronic paranasal sinus changes.” (Id. at 22.)
Petitioner received her EEG on September 8, 2015, at Saint Thomas Rutherford
Hospital. (Ex. 10, p. 9.) Her results showed abnormalities “due to right anterior
temporal sharp waves concerning for an epileptogenic focus at this region,” without any
ictal discharges observed. (Id.)
On September 11, 2015, petitioner returned to Dr. Thomas who noted that
petitioner’s EEG showed “left temporal sharp[] waves.” (Ex. 12, p. 10.) Dr. Thomas
also suggested petitioner’s memory loss “could be due to subclinical seizures,” and
prescribed a trial of Keppra. (Id.) Dr. Thomas wrote a letter noting that petitioner had a
severe reaction to the flu vaccine and recommended against further flu immunization on
October 23, 2015. (Ex. 11, p. 1.) On December 11, 2015, petitioner reported that
Keppra had relieved her hand spasms and Dr. Thomas added amlodipine to petitioner’s
Keppra regimen. (Ex. 12, pp. 2-4.) At this point, Dr. Thomas assessed petitioner with
unspecified convulsions. (Id. at 3.)
On February 18, 2016, petitioner was seen at the Community Clinic of Shelbyville
& Bedford County. (Ex. 11, p. 16.) She reported increased weakness lowered blood
pressure and was assessed with hypertension and “seizure disorder.” (Id.)
Petitioner was seen by Dr. Thomas again on March 11, 2016. (Ex. 13, p. 1.)
She reported that her right-hand spasms were returning, and that it felt “like how [it] gets
with a seizure.” (Id.) Petitioner also reported fatigue and depression “which she rates
as a 9/10 (used to be 10/10).” (Id. at 1, 3.) Petitioner’s physical exam did not reveal
any new problems, and Dr. Thomas recommended switching from Keppra to
oxcarbazepine (“OXC”). (Id. at 3.) Dr. Thomas assessed petitioner with “localization-
related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial
seizures, not intractable, without status epilepticus.” (Id.)
Petitioner was seen by Dr. Paul Buechel at Saint Thomas on May 20, 2016, for a
follow up on her memory issues. (Ex. 28, p. 32.) Petitioner reported that her memory
had been poor ever since her flu vaccination in October of 2014. (Id.) She described
not being able to remember bible verses as she did in the past and that she had
difficulty cooking very familiar recipes. (Id.) Petitioner explained that she had never
experienced an “actual seizure,” but noted that “every 15 minutes, her hands tighten.”
(Id.) Petitioner also reported that Dr. Thomas had witnessed “both of her hands
tightening and twisting at the same time,” which led Dr. Thomas to the conclusion that
petitioner was experiencing minor seizures. (Id.) However, because petitioner
explained that she was “completely awake throughout these episodes,” Dr. Buechel was
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of the opinion that her hand spasms were “not at all likely seizures.” (Id.) Dr. Buechel
did however recommend that petitioner avoid further flu immunizations due to her
reaction. (Id.)
Petitioner began psychiatric counseling at Centerstone Clinic on November 2,
2016. (Ex. 29, p. 9.) She reported anger, low motivation, low energy, stress,
forgetfulness, and denied any depression, suicidal/homicidal ideations, or psychosis.
(Id.) Petitioner further reported that she experienced an allergic reaction to the flu
vaccine and developed epilepsy. (Id.) She also explained that she suffered from a
stroke during the previous year. (Id.) Petitioner’s intake summary noted that her
presentation was consistent with a diagnosis of adjustment disorder, epilepsy, and
hypertension, and was recommended individual therapy once to twice per month. (Id.
at 10.)
Petitioner returned to Saint Thomas on September 1, 2017, and was seen by Dr.
Rejane Lisboa with a chief complaint of seizures and memory problems. (Ex. 28, p. 28.)
Petitioner reported the same history of present illness as she had to her previous care
providers, adding that she suffered an episode “when [her] head and arms were
moving” but had not experienced any seizure-type episodes since mid-late 2016. (Id. at
29.) She also reported that she believed her memory problems were becoming
progressively worse, she described forgetting dates and where she placed objects, but
that she had not had any trouble driving so long as she was not distracted. (Id. at 29-
30.) Petitioner’s exam was normal and Dr. Lisboa noted that early symptoms of
Alzheimer’s were not excluded. (Id. at 30.)
On May 22, 2018, petitioner underwent a two-day traumatic brain injury (“TBI”)
vocational assessment. (Ex. 24, p. 12.) The assessment noted petitioner experienced
a prior back injury with minimal spondyltiic endplate degenerative changes at the C4,
C5, and C6 levels with “mild degenerative changes in the vertebral endplates and facets
with mild disc bulging causing a disc/osteophyte complex, cervicalgia, calcifying
shoulder tendonitis, and left index finger bursitis.” (Id. at 12–13.) Petitioner also
reported memory impairments, inability to multi-task, difficulty sequencing, and
decreased attention. (Id. at 13.) Petitioner’s occupational therapist reported that
petitioner suffered from “(1) decreased function use of right upper extremity; (2)
decreased executive functioning; (3) decreased insight into viable vocational
possibilities; [and] (4) transportation [problems].” (Id. at 14.) Petitioner’s assessment
team recommended a neuropsychological evaluation, hearing evaluation, extending the
two-day assessment to four-days, and outpatient physical therapy if petitioner chose not
to complete the extended assessment. (Id. at 16.) Petitioner returned for further TBI
assessment on August 9, 2018. (Ex. 24, p. 18.) Of note, petitioner’s cognitive testing
showed that she was severely, moderately, or mildly impaired in all measures of
memory function with her “recent memory” score being the lowest, at 43. (Id. at 22.)
Petitioner received a neuropsychological evaluation at Sabin Behavioral Health
on December 20, 2018. (Ex. 23, p. 5.) She reported generally the same history as she
had up to this point, with the addition of experiencing full-body tremors at some point
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before the evaluation, though not specified. (Id.) She also explained that she had
trouble remembering names, the things that people said, where she placed her personal
belongings and had issues finding words, understanding directions, and maintaining
focus. (Id.) Petitioner’s memory indices were all observed to be “very low,” with the
exception of her visual working memory index, which was recorded as “low average.”
(Id. at 9.)
Petitioner was seen by physician’s assistant John Kramer at Saint Thomas on
October 18, 2019, for a follow up on her seizure disorder. (Ex. 28, p. 12.) Petitioner
reported that her most recent seizure occurred seven months prior, and that her full-
body tremors had returned. (Id. at 14.) PA Kramer noted that although petitioner
carried a diagnosis of “localization-related epilepsy,” this was “a working diagnosis,” and
asked petitioner to follow up with the hospital’s epilepsy specialist. (Id. at 17.) He also
noted that some of petitioner’s symptoms were concerning for “functional neurological
disorder,” and classified petitioner’s possible epilepsy as idiopathic and scheduled an
EEG. (Id.) Petitioner’s memory impairment was noted to be chronic, and the medical
code lists “other amnesia.” (Id.) Petitioner’s EEG was conducted on December 4,
2019, and was interpreted as normal with “no evidence of focal or abnormal epileptiform
discharges.” (Id. at 38.)
Petitioner returned to Saint Thomas on April 8, 2020 and was seen by Dr.
Vanderkolk for a follow up on her seizures and memory problems. (Ex. 28, p. 7.) Dr.
Vanderkolk reviewed petitioner’s medical history in detail, noting that her initial EEG
was unavailable, and that petitioner’s earlier brain MRI appeared normal with the
ischemic changes typical for petitioner’s age “and nothing apparently abnormal by my
view.” (Id. at 10.) Dr. Vanderkolk noted that, although the testing was limited due to
being conducted via phone, petitioner’s memory scores were quite poor. (Id.)
Petitioner was also observed to have a short temper and sporadic thoughts. (Id.) Dr.
Vanderkolk reviewed petitioner’s December 2019 EEG, which “was within normal
limits.” (Id. at 11.) Dr. Vanderkolk also noted that petitioner was insistent on changing
her medication, noting her “mood-related issues,” though Dr. Vandkerkolk noted that
Oxcarbazepine usually does not cause irritability or anger, and she wondered whether
petitioner suffered an underlying psychiatric condition or bipolar disease. (Id. at 11.)
Petitioner’s remaining medical records document routine requests for prescription
refills or unrelated exams. (See Ex. 27, pp. 55-96.) On April 15, 2021, petitioner
presented to nurse practitioner Shanna Gaither or a follow-up complaining of multiple
side effects with her antiepileptic medications. (Id. at 73-75.) NP Gaither noted
petitioner had not been seen by her neurologist in some time due to financial difficulties.
(Id. at 74.) Petitioner denied any new complaints and was recommended to follow-up
with her neurologist at St. Thomas or with a Vanderbilt neurologist. (Id. at 75.)
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b. As reflected in Petitioner’s Affidavit4
Petitioner filed an affidavit in support of her petitioner on February 7, 2022. (Ex.
25.) In her petition, petitioner affirms that she has never filed a civil action in relation to
her vaccination or alleged vaccine reaction. She also affirms that she has experienced
her symptoms for longer than six months and that she had no history of seizures,
cognitive issues, or memory problems. She further affirms that she received the flu shot
at her place of employment on October 21, 2014, that she received the shot “high on
[her] arm” and that it was “very painful and burning.” Petitioner also reports that she
experienced swelling at the injection site and began to feel really cold and dizzy
approximately three hours after receiving the vaccination. (Id. at 1.)
Petitioner then affirms that she took NyQuil and slept until 1:40 PM the following
day. She struggled to make it in to work and continued to feel sick and cold. Petitioner
also experienced hallucinations and felt dizzy and delirious. Petitioner states that she
experienced a seizure lasting approximately two minutes at 7:00 PM where both of her
hands seized and spasmed, but she did not report this to her supervisors for fear of
being fired. (Ex. 25, p. 2.) The following day, petitioner was asked to operate a tow
motor, but declined, explaining to her supervisor that she did not feel safe operating the
machinery. Petitioner reported that she fell asleep during the drive home from work that
day. (Id.) The second day after her vaccination, petitioner was let go from her job. She
states that she was able to drive home but did not remember the drive to or from work.
(Id.) Petitioner further affirms that she spent that weekend in bed, hardly able to get out
and experiencing continued chills and significant swelling of her injection site. (Id.) She
experienced “explosions in [her] head like fireworks” and “saw colors.” Petitioner
explains that she felt as though “cold air was pouring down” her brain through “a hole” in
her head. (Id.)
Petitioner’s symptoms led her to seek treatment at a free clinic on October 27,
2014. (Ex. 25, p. 2.) She was observed to have a fever of 101 degrees and flu was
suspected. (Id.) Petitioner was discharged after receiving a negative flu test and told to
seek help at the ER if she continued to feel ill. (Id.) Petitioner affirms that by October
27, 2014, she had a cough, fever, and chills all lasting for six days, but no sore throat.
(Id.) Petitioner’s symptoms slowly resolved in the subsequent weeks, but she continued
to seek treatment after being referred to Dr. Thomas, a neurologist. (Id.) Petitioner
affirms that Dr. Thomas diagnosed her with epilepsy which was believed to have been
triggered by her reaction to the flu shot. (Id.) Dr. Thomas prescribed the anti-epileptic
drug Keppra, which petitioner believed caused “horrible depression and suicidal
thoughts,” in addition to making her often angry, upset, and easily agitated. (Id.) Due to
these side effects, Dr. Thomas ceased Keppra and prescribed Oxcarbazepine which
petitioner indicated caused her to feel rage and experience homicidal thoughts without
stopping her seizures. (Id.) Ultimately, petitioner was prescribed lamotrigine which she
states has lessened the effects of her seizures. (Id. at 3.)
4 Petitioner did not testify at the entitlement hearing held on June 21, 2022. (Tr. 4.)
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Petitioner explains that she has had severe issues with her short-term memory
and reading comprehension. (Id.) Petitioner concludes her affidavit by writing that she
feels angry about her situation. (Id.) Specifically, she mentions being unable to able to
work; being a burden on her family; failing to meet her financial obligations; and losing
independence and community connection. (Id. at 3-4.)
V. Summary of Expert Opinions and Qualifications
a. Petitioners’ Expert – Carlo Tornatore, M.D.
Dr. Tornatore provided two expert reports in this case and testified at the
entitlement hearing. (Exs. 15, 22, Tr 5-202, 277-88.) He has been offered by petitioner
without objection as an expert in neurology and neuroimmunology. 5 (Tr. 10-11.)
i. Expert reports
Dr. Tornatore opines petitioner had “no symptoms referable to the central
nervous system” prior to her vaccination, and that she developed systemic neurological
symptoms shortly thereafter. (Ex. 15, p. 5.) Dr. Tornatore opines that petitioner’s
neurologic symptoms, which were primarily cognitive symptoms, persisted and could be
explained by the microvascular angiopathy/small vessel ischemic disease evidenced by
her initial MRI. (Id. (citing Johann Selvarajah et al., Potential Surrogate Markers of
Cerebral Microvascular Angiopathy in Asymptomatic Subjects At Risk Of Stroke, 19
EUR. RADIOLOGY 1011 (2009) (Ex. 17)).) Dr. Tornatore explains that small vessel
ischemic disease “is a result of atherosclerotic narrowing of the small caliber vessels of
the brain due to either hypertension, diabetes, or hyperlipidemia.” (Ex. 15, p. 5.) He
concedes that petitioner had hypertension, and thus, “clearly” had risk factors for
cerebrovascular disease, but was never symptomatic prior to her vaccination. (Id.) Dr.
Tornatore also opines that petitioner’s cognitive symptoms are consistent with ischemic
disease and that it is likely she had “significant aggravation of pre-existing risk factors,”
which were confirmed by petitioner’s subsequent EEG testing showing sharp waves
consistent with neuronal irritation. (Id. at 6.) According to Dr. Tornatore, the two most
common causes of “EEG changes” in a patient over the age of 50 are ischemic disease
and tumor. Petitioner’s MRI showed no evidence of any malignancy, therefore Dr.
Tornatore opines it is likely that petitioner suffered from ischemic disease. (Id.) Dr.
Tornatore concludes that petitioner’s symptoms did not arise until after her vaccination,
5 Dr. Tornatore is currently Chair and Neurologist-in-Chief of the Georgetown University Hospital
department of neurology and regional director for neurology at Medstar Health. He previously served as
vice chair of Georgetown’s department of neurology, and professor of neurology at Georgetown
University Medical Center. (Ex. 26, p. 3.) Dr. Tornatore received his bachelor’s degree in neurobiology at
Cornell University and holds a master’s degree in physiology and a medical degree from Georgetown
University. (Id. at 2.) Dr. Tornatore completed his internship in internal medicine at Providence Hospital
in Washington, DC and his residency in neurology at Georgetown University Hospital. (Id.) Dr. Tornatore
is currently licensed to practice medicine in the District of Columbia and board certified in Neurology by
the National Board of Psychiatry and Neurology. (Id. at 1.) He testified that he “also attend[s] on
service…[and] [sees] stroke patients, so I’m very familiar with vascular disease of the nervous system as
well as coronary artery disease, which is part and parcel with it.” (Tr. 10.) Dr. Tornatore has published 58
different peer reviewed articles and five book chapters on neurology and virology. (Ex. 26, pp. 8–14.)
11
and therefore, there is a logical sequence of cause and effect suggesting that her
vaccination triggered her ischemic disease which led to her neurologic symptoms. (Id.)
Dr. Tornatore opines it is biologically plausible that vaccination can cause or
aggravate vascular disease / microvascular angiopathy. (Id.) According to Dr.
Tornatore, it is “well recognized that vascular disease is caused by a cascade of
inflammatory changes in the wall of blood vessels.” (Ex. 15, p. 6.) He explains that
atherosclerosis involves an ongoing inflammatory response. (Id. (citing Peter Libby et
al., Inflammation and Atherosclerosis, 105 CIRCULATION 1135 (2002) (Ex. 18)).) Dr.
Tornatore opines it “is well recognized that the influenza vaccination results in a variety
of inflammatory responses.” (Ex. 15, p. 6.) He cites a study finding a measurable acute
phase response following influenza vaccination in men with and without severe carotid
artery disease. (Id. (citing Cara L. Carty et al., Inflammatory Response After Influenza
Vaccination in Men With and Without Carotid Artery Disease, 26 ARTERIOSCLER
THROMBOSIS VASCULAR BIO. 2738 (2006) (Ex. 20)).) Based on these studies, Dr.
Tornatore concludes that “a vaccine-induced inflammatory cascade” could result in
vascular disease similar to what was seen on petitioner’s MRI and EEG. (Ex. 15, pp. 6–
7.)
Dr. Tornatore cites a case report of a 75-year-old man who developed a stroke
after influenza/H1N1 vaccination. (Ex. 15, p. 7 (citing Yi-Pin Lin et al., Ischaemic Stroke
and Influenza A H1N1 Vaccination: A Case Report, 2 ARCHIVES MED. SCI. 345 (2011)
(Ex. 21)).) The authors noted that the VAERS data suggested that the seasonal flu
vaccine was the most common vaccine associated with ischemic stroke, that ischemic
stroke occurred within a day of vaccination in 18% of patients, and that flu vaccination
may result in a pro-thrombotic state due to immune upregulation. (Ex. 15, p. 7.) Dr.
Tornatore opines that this medical literature is relevant to petitioner’s case because she
“already had risk factors for atherosclerotic disease/narrowing of the small vessels,”
which could have been aggravated by a flu vaccination causing the cognitive issues and
sharp waves seen on EEG. (Id.) Ultimately, Dr. Tornatore opines that petitioner’s
October 21, 2014, flu vaccination aggravated her pre-existing atherosclerotic disease
causing the neuronal irritability and cognitive symptoms she alleges. (Id.)
In his supplemental report, Dr. Tornatore focuses primarily on what he considers
points of agreement with Dr. Evans. (Ex. 22.) Dr. Tornatore summarizes his opinion as
follows: “[petitioner] developed symptomatic microvascular disease of the central
nervous system attributable to the influenza vaccination she received on October 21,
2014. (Id. at 2.) This [is] based on a striking temporal relationship between the onset of
her symptoms, a logical sequence of cause and effect and a biologically plausible
mechanism by which vaccination could cause aggravation of pre-exiting microvascular
disease.” (Id.) By Dr. Tornatore’s account, the primary, if not only, point of
disagreement between the experts is whether petitioner’s pre-vaccination complaints of
cognitive concerns during therapy are grief related (per Dr. Tornatore) or consistent with
her later cognitive complaints (per Dr. Evans). (Id. at 3-4.) Dr. Tornatore suggests that
Dr. Evans contradicts himself when he suggests that petitioner complained of cognitive
issues prior to her vaccination, e.g., her complaints of “cloudy thoughts” and “not being
12
able to get it together,” while also writing that they appeared to be related to her
depression. (Id. at 3.)
ii. Testimony
Dr. Tornatore also testified during the hearing. (Tr. 5-203, 277-88.) He clarified
that his opinion is “the influenza vaccination that [petitioner] received on October 21st,
2014, resulted in an inflammatory response that significantly aggravated her underlying
microvascular angiopathy, resulting in a convulsive disorder and the symptomatically
cognitive issues that were persistent.” (Id. at 12.) Specifically, Dr. Tornatore opines
that petitioner received the flu vaccine at issue, suffered “clear systemic symptoms
related to the vaccine, which are chemokine- and cytokine-related that happen within a
short period” causing endothelial changes or changes in blood vessel tone that mimic a
wild-type influenza virus, “which we know can cause cerebrovascular disease.” (Id. at
62.) In turn, “cerebrovascular disease is the most common…cause of epilepsy when
you can identify a cause for it.” (Id.)
Animal models, according to Dr. Tornatore, have demonstrated inflammatory
responses to vaccination. (Id. at 42 (citing Jacqueline McDonald et al., Inflammatory
Responses to Influenza Vaccination at the Extremes of Age, 151 IMMUNOL. 451 (2017)
(Ex. 19)).) Dr. Tornatore referred to results from a mouse study that reported a positive
correlation between an animal’s inflammatory response and its age. (Id. (citing
McDonald et al, supra at Ex. 19.).) Specifically, Dr. Tornatore pointed out that neonatal
mice had more IL-1 alpha; young adult mice had more TNF alpha; and elderly mice had
more IL-1 receptor agonist. (Tr. 42.) Dr. Tornatore asserted that the post-vaccine
increase in inflammatory markers in mice is identical to an increase observed in
humans. (Id. (citing Libby et al., supra at Ex. 18).)
Dr. Tornatore proposes that petitioner experienced a “cytokine response” post-
vaccination, which reproduced “the exact same response that one gets with the wild-
type infection.” (Tr. 30.) He referred to two studies that support this theory. (Id. at 29-
30.) The first study examined recipients of solid organ transplant and compared
responses to vaccination versus natural infection. (Id. at 29 (citing Arnaud G. L’Huillier
et al., T-cell responses following Natural Influenza Infection or Vaccination in Solid
Organ Transplant Recipients, 10 SCI. RPT. 1 (2020) (Ex. 34)).) Dr. Tornatore
acknowledged that petitioner did not have an organ transplant. (Id.) He nevertheless
relies on the cytokine response observed in this study to infer that petitioner
experienced a cytokine response to vaccination, which was of a similar amplitude to an
expected response to wild-type infection. (Id. at 30.) The second study examined
serum cytokines and chemokines after vaccination. (Id. (citing Kawsar Talaat et al.,
Rapid Changes in Serum Cytokines and Chemokines in Response to Inactivated
Influenza Vaccination, 12 INFLUENZA OTHER RESPIR. VIRUSES 202 (2018) (Ex. 35)).)
Dr. Tornatore highlighted an outlier in this study, who showed the most robust cytokine
response: a 32-to-64-fold increase in hemagglutination-inhibition titer. (Tr. 31 (citing
Talaat et al., supra, at Ex. 35).) Dr. Tornatore suggested this increase could be due to
prior exposure to either to the virus or to a similar vaccine. (Id. at 32.) Regardless, he
13
stressed that this study demonstrates that patients may experience a significant
cytokine and chemokine response within a short period of time, even within hours of
vaccination – “as was the case with [petitioner].” (Tr. 32.)
Dr. Toratore opines, “whether you get an infection or whether you get vaccinated,
the cytokine patterns are identical[,] [though] [t]he amplitude may be less noted.” (Id. at
29-30.) Dr. Tornatore testified that the Nichols paper, cited by Dr. Evans, speaks to this
same concept. (Id. at 55.) Dr. Tornatore testified “[p]ossible mechanisms of the
increased risk of cerebrovascular and cardiovascular events after upper respiratory tract
infection, such as influenza, include alterations in circulating clotting factors, platelet
aggregation and lysis, concentration of inflammatory response proteins and alteration in
cytokine concentrations.” (Id. (quoting Kristin Nichols et al., Influenza vaccination and
reduction in hospitalizations for cardiac disease and stroke among the elderly, 34 N.
ENGL. J. MED. 1 (2003) (Ex. EE)).) These changes, according to Dr. Tornatore, “might
enhance thrombotic tendencies, impair basal dilation, or cause endothelial injury.” (Tr.
55.) To Dr. Tornatore, the evidence suggesting flu infection can cause an increased
risk of cerebrovascular and cardiovascular events supports the theory that the flu
vaccine can significantly aggravate thrombotic tendencies or endothelial injury in a
vaccinee like petitioner who is predisposed to such cerebrovascular events. (Id. at 33.)
During the hearing Dr. Tornatore offered an additional case report by Thoon and
Chan, describing a pediatric stroke case post influenza vaccination. (Tr. 46-7 (citing
Koh Cheung Thoon & Derrick Wei Shih Chan, Childhood stroke after influenza
vaccination, 21(2) PROC. SINGAPORE HEALTHCARE 296 (2012) (Ex. 31)).) The authors
acknowledged that this was the first reported case, and Dr. Tornatore likewise opined
that “[t]his is very unusual – you know, children don’t get strokes.” (Tr. 47 (citing Thoon
& Chan, supra, at Ex. 31).) The ten-year-old developed a stroke in the cerebellum one
day after receiving the seasonal trivalent influenza vaccine. (Tr. 47.) Dr. Tornatore
acknowledges the possibility that the child may have been predisposed to stroke but
maintained that “this may have been an inflammatory event that caused this stroke due
to the vaccine, given the very striking temporal relationship and the…absolute rarity of
stroke in children.” (Id.) He stresses the usefulness of case reports in teaching the
“clinical tempo” of disease, including rare diseases. (Id.) Among the case reports filed
in this case, Dr. Tornatore underscores the fact that each had “the same kinetics of a
stroke within a very short period of the vaccinations.” (Id. at 48.)
b. Respondent’s Expert – Steven Evans, M.D.
Dr. Evans likewise provided two reports and testified at the entitlement hearing.
(Ex. A, CC, Tr. 203-277.) He has been offered by respondent without objection as an
expert in neurology and epilepsy. 6 (Tr. 208.)
6 Dr. Evans received his medical degree in 1982 and his Master of Science degree in physiology in 1984
from the University of Louisville. (Ex. B.) He completed his neurology residency training and chief
residency at Barnes Hospital and the Washington University School of Medicine. (Id.) He completed a
research fellowship in neuropharmacology at the same institution. (Id.) Dr. Evans currently serves as a
practicing neurologist, partially retired, subspecializing in the diagnosis and treatment of epilepsy. (Ex. A,
p. 1; Tr. 204.) He attends the epilepsy monitoring unit at the University of Louisville, where he sees
14
i. Expert reports
Dr. Evans opines that petitioner simply suffered from influenza or a flu-like
syndrome after her vaccination which triggered her symptoms. (Ex. A, p. 4.) He writes
that petitioner’s complaints of “cloudy thoughts” and “not being able to get it together,”
were thought to be related to her depression and that her subsequent memory issues
were never objectively observed on physical exam. (Id.) Dr. Evans concludes that
isolated memory loss has not been reported as an adverse reaction to vaccination and
characterizes her pre-vaccination complaints as similar to her memory complaints. (Id.)
With regard to petitioner’s epilepsy diagnosis, he opines that her “neurological
symptoms and results of testing point to a diagnosis of right temporal lobe epilepsy.”
(Id. at 4.) He explains that epilepsy is a condition that predisposes an individual to
seizures, and that the condition precedes the seizures, but cannot be definitively
diagnosed before seizures occur. (Id.) He further explains that seizures may be
generalized or focal in onset and that seizures affecting or originating in the temporal
lobe characteristically produce temporary amnesia in the ictal and postictal state, with
occasional long-lasting temporary amnesia or other memory-related symptoms such as
déjà vu or jamais vu. (Ex. A, p. 4 (citing Olivier Felician et al., Transient epileptic
amnesia: Update on a slowly emerging epileptic syndrome, 171 REVUE NEUROLOGIQUE
289 (2015) (Ex. K)).)
Dr. Evans notes that temporal lobe epilepsy is usually associated with chronic
memory loss and cognitive deficits specifically associated with memory. (Ex. A, p. 4
(citing Eve Tramoni-Negre et al., Long-term memory deficits in temporal lobe epilepsy,
173 REVUE NEUROLOGIQUE 490 (2017) (Ex. X); Cettina Allone et al., Neuroimaging and
cognitive functions in temporal lobe epilepsy: A review of the literature, 381 J. OF
NEUROLOGICAL SCI. 7 (2017) (Ex. C)).) Dr. Evans writes that the chronic memory loss of
epilepsy “causes difficulty making new memories, not the forgetting of already-
established memories . . .” (Ex. A, p. 4.) Further, “the memory complaint[s] of persons
with epilepsy is chronic and bothersome, but nonprogressive,” which also appears
consistent with petitioner’s symptoms. (Id.) According to Dr. Evans, the causes of
memory dysfunction in temporal lobe epilepsy include brain tissue damage, seizures,
medications, and associated mood disorders, especially depression. (Id. (citing
Matthew J. Knight & Bernhard T. Baune, Cognitive dysfunction in major depressive
disorder, 31 CURRENT OPINIONS IN PSYCHIATRY 26 (2017) (Ex. P)).)
Dr. Evans agrees that petitioner’s EEG showing right temporal epileptiform
discharges is an inter-seizure pattern highly suggestive of right temporal lobe epilepsy.
(Ex. A, p. 5.) However, he writes, evidence of “small vessel ischemic disease on MRI is
very common, and is associated with age, hypertension, and diabetes. Non-lesional
temporal lobe epilepsy is very common, almost the rule rather than the exception. (Id.
(citing Wolfgang Muhlhofer et al., MRI-negative temporal lobe epilepsy–What do we
patients and reads EEGs. (Tr. 204.) He also currently serves as a full Professor in the Department of
Neurology at the University of Louisville. (Ex. A, p. 1.) He is board-certified in Neurology and also
boarded in Clinical Neurophysiology and Epilepsy. (Id.)
15
know?, 58 EPILEPSIA 727 (2017) (Ex. U)).) Dr. Evans writes that additional confirmatory
testing for epilepsy such as formal validation of bedside mental status,
neuropsychological testing, and prolonged EEG monitoring was not done. (Ex. A, p. 5.)
Despite the above, Dr. Evans emphasizes that “no definite occurrence of
seizures” were ever documented. (Ex. A, p. 5.) With regard to petitioner’s hand
spasms, he explains that spasms with retained consciousness are only very rarely
seizures. (Id.) Further, Dr. Evans writes that focal onset epilepsy with focal motor
seizures causes unilateral hand convulsions in the limb opposite to the epileptic brain
tissue, while petitioner complained of bilateral spasms and later, right hand spasms and
cramping. (Id.) Although Dr. Evans concedes that unilateral limb convulsions can occur
in temporal lobe epilepsy, “the more prominent symptoms in this seizure type is sudden
alteration of consciousness, and amnesia is the rule, so the convulsion symptoms must
be reported by witnesses.” (Id.) With no indication that any of petitioner’s alleged
seizures were witnessed by treating physicians or lay witnesses, Dr. Evans concludes
that the characterization of her hand spasms as seizures is “very questionable.” (Id.)
Moreover, petitioner’s physicians believed that she suffered from subclinical
seizures; and Dr. Evans notes that “[t]he concern was that non-convulsive or subtle
seizures may have been occurring, and could be the cause of her complaint of memory
loss.” (Ex. A, p. 5.) He opines this condition is “relatively rare, and can only be
substantiated by prolonged video-EEG monitoring and subsequent relief of seizures and
symptoms by treatment with antiepileptic drugs.” (Id.) Notably, in 30 to 50% of cases,
symptoms thought to be the result of seizures were found to be psychogenic, non-
epileptic events. (Id.) Dr. Evans emphasizes that “the effect of the therapeutic trial of
Keppra on her memory was not specifically noted by clinicians.” (Id.) As for petitioner’s
reported hallucination, Dr. Evans opines that this symptom “does not help to refine a
neurological diagnosis,” as “psychosis and seizures are symptoms of limbic
encephalitides, especially anti-NMDA-receptor encephalitis [and] only one case report
has appeared linking vaccination to anti-NMDA-receptor encephalitis . . . .” (Id. (citing L
Hozakova et al., Anti-NMDAR encephalitis as a serious adverse event probably related
to yellow fever vaccination, 24 CLIN. MICROBIO. INFECTION 17 (2018) (Ex. O)).) Thus, the
link between these symptoms and vaccination must be considered “extremely tenuous.”
(Ex. A, p. 5.) In Dr. Evans opinion, petitioner’s epilepsy diagnosis is “very reasonable,”
but because “no epileptic seizures were noted, the diagnosis would be provisional.”
(Id.)
Turning to the question of whether petitioner’s vaccination could cause her
epilepsy, Dr. Evans reports that he was unable to locate any cases of temporal lobe
epilepsy following vaccination, but that seizures in epileptic patients are commonly
precipitated by viral illness, bacterial infection, and fever. (Id. at 6.) Dr. Evans notes
that petitioner complained of fever and was diagnosed with a viral syndrome shortly
after her vaccination. (Id.) He explains that studies of pediatric patients have found that
fever is associated with seizures even in those without epilepsy, and that while
vaccinations have been found to slightly, or not at all, increase the risk of seizure in
epileptic children, no association between epilepsy and vaccination has ever been
16
found. 7 (Id. (citing Lisen Arnheim-Dahlstrom et al., Risk of presentation to hospital with
epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic
A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study, 345 BMJ
e7594 (2012) (Ex. F); Inger Johanne Bakken et al., Febrile seizures after 2009 influenza
A (H1N1) vaccination and infection: a nationwide registry-based study, 15 BMC
INFECTIOUS DISEASES 506 (2015) (Ex. G); Xin Li et al., The influence of vaccine on febrile
seizure, 16 CURRENT NEUROPHARMACOLOGY 59 (2018) (Ex. S); Karina A. Top et al., Risk
of seizures after immunization in children with epilepsy: a risk interval analysis, 18 BMC
PEDIATRICS 134 (2018) (Ex. W); Siri E. Haberg et al., Epilepsy in children after pandemic
influenza vaccination, 141 PEDIATRICS e20170752 (2018) (Ex. M)).) Dr. Evans reports
that he was unable to find any reported cases of temporal lobe epilepsy where the first
seizures were precipitated by vaccination, but indicates that he has treated patients
whose first seizures were precipitated by a viral illness. (Ex. A, p. 7.) Ultimately, Dr.
Evans concludes that the medical records suggest that petitioner’s epilepsy was
triggered by a viral illness and not her vaccination. (Id.)
Finally, Dr. Evans addresses several claims made by Dr. Tornatore in his initial
expert report. (Ex. A, p. 7.) First, Dr. Evans contends that the medical evidence does
not suggest that petitioner suffered a detectable stroke and that “if stroke were found it
would poorly explain her memory loss.” (Id.) Dr. Evans notes that isolated memory
dysfunction caused by stroke is rare when not accompanied by other signs or
symptoms. (Id.) Further, when isolated memory loss is present, it is suggestive of
bilateral stroke of the medial temporal lobes or thalamus. (Id.) Although “multi-infarct
dementia” is relatively common in stroke victims, it is usually associated with clinically-
diagnosable stroke and accompanied by other signs and symptoms. (Id. (citing
Alzheimer’s Ass’n, Vascular Dementia 1–4, (2018) (Ex. D); Didier Leys, Poststroke
dementia, 4 LANCET NEUROLOGY 752 (2005) (Ex. R)).) Dr. Evans notes that petitioner’s
radiographic imaging did not reveal signs of a stroke, but rather a very common and
nonspecific finding of “minimal periventricular white matter demyelinization likely from
chronic small vessel ischemic disease” regularly found in middle aged, elderly, and
7 Dr. Evans acknowledges there are some cases of vaccine-associated encephalopathy and severe
seizures in children, but that “[t]hese mostly turned out to be cases of Dravet syndrome (severe myoclonic
epilepsy of infancy) with the first symptoms precipitated by malaise and fever after vaccination.” (Ex. A, p.
6.) However, Dravet syndrome is usually caused by a mutation in the SCN1A gene. (Id. (citing
Tarannum M. Lateef et al., Seizures, encephalopathy, and vaccines: experience in the national vaccine
injury compensation program, 166 J. OF PEDIATRICS 575 (2015) (Ex. Q); Lieve Claes et al., De novo
SCN1A Mutations are a major cause of severe myoclonic epilepsy of infancy, 21 HUM. MUTATION 615
(2003) (Ex. J)).) Dr. Evans stresses that in these cases, “vaccination did not cause but did appear to
precipitate the first observable seizures of a catastrophic genetically-determined epilepsy,” with similar
precipitation of seizures observed in other childhood epilepsies such as Doose syndrome. (Id. (citing
Samuel F. Berkovic et al, De-novo mutations of the sodium channel gene SCN1A in alleged vaccine
encephalopathy: a retrospective study, 5 LANCET NEUROL. 488 (2006) (Ex. H); Natasha J. Brown et al.,
Vaccination, seizures and ‘vaccine damage’, 20 CURR. OP. NEUROL. 181 (2007) (Ex. I); Nienke E. Verbeek
et al., Etiologies for seizures around the time of vaccination, 134 PEDIATRICS 658 (2014) (Ex. Y); Sarah
von Spiczak et al., A retrospective population-based study on seizures related to childhood vaccination,
52 EPILEPSIA 1506 (2011) (Ex. Z)).)
17
hypertensive persons at a rate of 50-98%. (Ex. A, p.7 (citing Vincent Mok et al., Race-
ethnicity and cerebral small vessel disease – Comparison between Chinese and white
populations, 9 INT’L J. OF STROKE 36 (2014) (Ex. T)).) Dr. Evans notes that, while chronic
small vessel ischemic disease is not known to cause symptoms by itself, it has been
correlated with increased dementia and demyelinating lesions in dementia patients.
(Ex. A, p. 7 (citing Doeschka A. Ferro et al., Clinical relevance of acute cerebral
microinfarcts in vascular cognitive impairment, 92 NEUROLOGY e1 (2019) (Ex. L)).)
Finally, although confluent demyelination has been associated with vascular dementia,
Dr. Evans notes that petitioner’s MRI showed minimal, and not confluent demyelination,
and therefore, petitioner is unlikely to have suffered from vascular dementia. (Ex. A, p.
7.)
Dr. Evans concludes that in contrast to ischemic disease, where isolated memory
dysfunction rarely occurs, it is quite common in temporal lobe epilepsy. (Id.) Further,
petitioner’s EEG was highly suggestive of right temporal lobe epilepsy. (Id.) Dr. Evans
writes that Dr. Tornatore was mistaken to suggest that the two most common causes of
EEG changes are tumor and ischemic disease, because the most common cause of
EEG changes is epilepsy which “may in turn be associated with ischemic disease or
tumor, and both increase the risk of epilepsy.” (Id.) Dr. Evans ultimately opines that
petitioner’s correct diagnosis was epilepsy but that it is highly unlikely to have been
caused by her vaccination and could have been triggered by fever or petitioner’s viral
syndrome. (Id.)
In his supplemental expert report, Dr. Evans suggests that petitioner’s complaints
of “cloudy thoughts” and “not being able to get it together” were cognitive, not
behavioral, complaints that preceded her vaccination. (Ex. CC, p. 1 (citing Ex. 5, p. 23;
Ex. 11, p. 35).) Dr. Evans agrees that petitioner was correctly diagnosed with epilepsy,
but reiterates that petitioner’s MRI finding of chronic small vessel ischemic disease is
very common and does not support a finding of symptomatic microvascular disease.
(Ex. CC, pp. 1-2.) Dr. Evans agrees that systemic exposure to viral or bacterial
elements can precipitate seizures or neuronal irritability, but he stresses that they
“precipitate acute symptomatic seizures in non-epileptic patients (rarely) or seizure
breakthroughs in epileptic patients (commonly),” and are not expected to cause
epilepsy. (Id. at 2.) Dr. Evans acknowledges that vaccinations can be temporally
associated with epilepsy because they may induce a fever and lower the seizure
threshold. (Id. at 3.) That fact alone, however, is not enough to infer causation. (Id.)
ii. Testimony
Dr. Evans also testified at the entitlement hearing. (Tr. 203-277.) Regarding
petitioner’s causation theory, and whether vascular disease is caused by inflammation,
Dr. Evans cautioned that the term “inflammation” is used commonly in the literature
though it holds many different meanings. (Id. at 258-59.) In fact, he testified that
inflammation is thought to be involved “in almost every neurological disease right now.”
(Id. at 259.) Migraines, spinal cord trauma, brain trauma, as well as epilepsy and stroke
and are all associated with inflammatory changes, according to Dr. Evans. (Id.) He
18
testified that whether inflammation causes stroke is up for debate. (Id. at 259-60.) Dr.
Evans explained that the “ultimate cause” of most stroke is either platelet emboli or
fibrin emboli—“[s]o something, whether inflammatory or noninflammatory, causes clots
to form on vessels that then embolize to other vessels or cause a large enough clot
inside you to occlude blood vessels.” (Id. at 260.) Other cases may involve chronic,
increasingly greater stenosis, causing stroke, though Dr. Evans opines that gradually
developing stenosis isn’t considered a significant risk factor for stroke. (Tr. 260.) In
petitioner’s case, no sedimentation rate or CRP tests were performed that could have
revealed inflammation in petitioner’s central nervous system. (Id. at 261.) If Dr. Evans
were treating petitioner as a patient, and believed petitioner suffered inflammation of the
nervous system, he testified that he would have ordered a lumbar puncture to look for
leukocytes or lymphocytes in the spinal fluid, for example. (Id.) In petitioner’s case
none of these tests were done, and according to Dr. Evans, “the obvious reason for that
is because they weren’t concerned about that.” (Id.)
Of the case reports cited by petitioner, Dr. Evans testified that only the Thoon
and Chan report showed some evidence suggesting the flu vaccine is associated with
stroke. (Tr. 263.) The ten-year-old patient suffered a cerebellar stroke post flu
vaccination. (Id.) However, Dr. Evans stresses that the authors did not test any
inflammatory markers or demonstrate any inflammatory marks in that case. (Id.) To be
sure, the authors performed an MRI scan and EEG. (Id.) “So, yes, the patient clearly
had a stroke and it clearly showed on MRI, and it clearly happened shortly after a
vaccination,” but Dr. Evans contends the authors fail to show signs of inflammation that
might be the base of physiologic significance. (Id.)
During his testimony, Dr. Evans amended his opinion in two regards. First, Dr.
Evans testified that he opines petitioner “may have epilepsy.” (Tr. 266.) This is not
inconsistent with his expert reports, however, at the hearing, he explained that “[i]t’s
been…two, three years since I wrote my initial opinion on it…I do not disagree with the
treating physicians having a working diagnosis of epilepsy. However, three years is
plenty of time to reduce the working diagnosis to a certainty, and that hasn’t been
done.” (Id.) Moreover, based on the little evidence in favor of epilepsy, Dr. Evans
opines “I would not tell her she has epilepsy and not treat her for epilepsy until I have
more evidence in favor of epilepsy.” (Id. at 266-67.) Relatedly, Dr. Evans testified that
petitioner’s depression, not her provisional diagnosis of epilepsy, is the most likely
cause of her memory dysfunction. (Id. at 271-72.) He explains that the two diagnoses
that would be associated with poor performance on her neuropsychological test (that
demonstrated cognitive dysfunction) would be depression or possibly epilepsy. (Id.)
Again, while epilepsy was a “good working diagnosis in 2019,” he stresses it has not
been proven in petitioner’s case. (Id. at 272.) That leaves depression as the most likely
cause of her memory dysfunction.
Dr. Evans also amended his opinion regarding the results of petitioner’s EEG
monitoring. (Tr. 211-12, 216.) In particular, he testified that petitioners first EEG results
revealed unilateral discharges. (Id. at 211.) The second, later EEG was interpreted as
normal. (Id.) Dr. Evans testified the first EEG showed temporal lobe discharges, which
19
is common in temporal lobe epilepsy. (Id.) The confusion regarding the EEG stems
from the fact that the EEG report indicated right temporal lobe discharges, but Dr.
Thomas, one of petitioner’s treating neurologists opined that petitioner had left temporal
lobe discharges. (Id. (discussing Ex. 10, p. 9; Ex. 12, p. 10).) On further examination,
Dr. Evans testified that petitioner likely had left temporal lobe discharges because the
EEG report specifically mentioned F7 and T3 electrodes were affected, which are
electrodes in the left side of the head. (Tr. 211-12.) He concludes that the impression
in the report was incorrect. (Id. at 212.) Dr. Evans testified that, either way, the results
indicated focal epileptic discharges in the temporal lobe. (Id.) Focal seizures are
considered unilateral, occurring in only one half of the brain. (Id.) Given the foregoing,
Dr. Evans opines that petitioner did not experience epileptic seizures—what she
describes were bilateral hand movements that occurred in the absence of other
symptoms. (Id.)8
VI. Discussion
In light of petitioner’s framing of the case, the analysis below utilizes the first
three Loving prongs to address several key factual predicates to petitioner’s claim.
However, the resolution of these factual issues is the same regardless of whether
petitioner’s claim is ultimately analyzed as a significant aggravation under the Loving
test or as an injury caused-in-fact by vaccination under the Althen test. This is primarily
addressed within the analysis pursuant to Loving prong five/Althen prong two, which
requires a logical sequence of cause and effect linking the vaccine and the injury under
either type of analysis.
a. Loving prong one
The first Loving prong involves an examination of petitioner’s pre-vaccination
condition. In this case, two factual points relating to petitioner’s pre-vaccination
condition help to inform whether petitioner’s overall explanation of events is likely. First,
petitioner must establish that she had preexisting asymptomatic microvascular
angiopathy. (ECF No. 56, p. 11; Tr. 12.) Second, in order to ultimately establish
petitioner’s epilepsy first arose post-vaccination under Loving prong two, petitioner must
be persuasive in contending that the cognitive complaints attributable to that epilepsy
also first arose post-vaccination. That requires examination of respondent’s contention
that petitioner’s pre-vaccination counseling records document cognitive complaints
approximately one month prior to the vaccination at issue. (ECF No. 61, p. 2; ECF No.
60, pp. 23-24.)
8 However, Dr. Evans also testified that, based on this opinion, the discharges were on the left side could
“at least be consistent with that particular symptom of spasm in the right hand” and the “writing discomfort
may be related to that.” (Tr. 217.) However, he maintains, “[b]ilateral hand symptoms do not make
sense.” (Id.)
20
i. Asymptomatic microvascular angiopathy
Dr. Tornatore’s suggestion that petitioner had preexisting microvascular
angiopathy is based on two considerations. (Tr. 15-16, 59.) First, he notes petitioner
had risk factors for microvascular disease, including hypertension, obesity, and
hyperlipidemia. (Id. at 15.) Second, he suggests that petitioner’s August 20, 2015 MRI
had some evidence of “minimal” abnormality constituting chronic small vessel vascular
disease. (Ex. 12, p. 22.) He opines that the changes seen on the MRI would not have
happened within the span of a year. Thus, he suggests the changes necessarily
predated her vaccination. (Tr. 17.)
Importantly, however, Dr. Tornatore also suggests, based on his interpretation of
petitioner’s history, that the alleged microvascular angiopathy was having no impact on
her health prior to vaccination – “it was not presenting at all.” (Tr. 20-21.) In that regard,
petitioner’s treating neurologists interpreted petitioner’s MRI as being “within normal
limits” for her age. (Tr. 72-74.) Specifically, Dr. Thomas, the physician that initially
ordered the MRI to evaluate petitioner’s memory problems, interpreted the resulting MRI
as “wnl [within normal limits] for age.” (Ex. 12, p. 10.) Subsequently, Dr. Buechel
additionally characterized the MRI as “normal.” (Ex. 28, p. 32.) Later providers likewise
concluded the MRI was essentially normal. (Ex. 28, p. 12 (PA-C Kramer); Ex. 28, p. 10
(Dr. Vanderkolk, indicating “minimal periventricular white matter ischemic changes were
seen typical for her age and nothing apparently abnormal by my view.”).)
For his part, Dr. Evans limited his opinion because he has not reviewed the MRI
and allowed the possibility that the MRI “might be evidence of ischemia,” but stressed
that what petitioner’s treating physicians described is a “very common finding,”
explaining that “if normal means most people have it, then it would be normal.” (Tr. 231-
32.) When challenged on cross-examination, Dr. Tornatore maintained that an
abnormality was present, but also acknowledged that “I don’t disagree” that the findings
are normal for someone of petitioner’s age. (Tr. 73.)
On the whole, while Dr. Tornatore is persuasive in suggesting that the changes
evidenced by the August 20, 2015 MRI are likely to have predated the vaccination given
that they are chronic and age-related, he has not preponderantly supported that they
are clinically significant.
ii. Cognitive impairment
Prior to vaccination, petitioner sought counseling for mild depression triggered by
the passing of her sister and cousin. (Ex. 5, pp. 2-13.) On September 18, 2014, about
a month prior to the vaccination at issue, petitioner presented for a psychotherapy
session wherein she reported “cloudy thoughts” and “not being able to get it together.”
(Id. at 23.) There is no dispute as to the fact of this report of cognitive complaints.
However, in order to support his assertion of a “striking” relationship between
petitioner’s post-vaccination illness and her cognitive problems, Dr. Tornatore opines
21
that these reports are entirely unrelated to any subsequent complaints of memory
issues.
According to Dr. Tornatore, this pre-vaccination cognitive complaint is distinct
from petitioner’s later cognitive complaints that were reported post-vaccination because
it is grief related and best understood as “pseudodementia,” which he characterizes as
“where somebody’s so depressed that they can’t think right.” (Tr. 26.) He adds that it is
also distinct because it reflects “somebody who has great insight into what their
problems are and recognizing it as such.” (Id.) For his part, Dr. Evans describes
pseudodementia as representing depression so profound that it can be misdiagnosed
as dementia. (Id. at 252-53.) Absent that, Dr. Evans suggests that there is no reliable
way to parse petitioner’s lay reports of cognitive difficulties. Dr. Evans opines that,
whether related to depression or epilepsy, petitioner’s pre- and post-vaccination
cognitive complaints should be considered together rather than trying to distinguish one
type of complaint from another. (Id.) Importantly ,Dr. Tornatore does acknowledge that,
but for his assessment of the specific context in this case, a report of “cloudy thoughts”
could be representative of a cognitive complaint, even in the context of a history of
depression. (Id. at 149.) In that regard, Dr. Tornatore’s assessment of the record as
clearly evidencing pseudodementia is not well supported.
Petitioner first presented for therapy related to a “rough patch” in her life in July of
2014. At that time, her initial assessment documented age-appropriate memory and
thought processes. (Ex. 5, p. 10.) She was initially assessed as having bereavement,
not depression. (Id. at 12.) Petitioner was not assessed as having any pseudodementia
and no other notations in the therapy records suggest that petitioner was experiencing
grief-related cognitive difficulties. Viewing the therapy records as a whole, the
September 18, 2014 notation of a cognitive complaint is an isolated instance rather than
constituting any clear part of her pattern of depression. Additionally, while her course of
therapy was targeted to depression and grief counseling overall, the records reflect
discussion of issues that were not limited to grief. The record of the session at which
the statements were made indicates that three goals were addressed at that session:
“relationship building, grief[,] and current functioning.” (Id. at 23.) Nor does the record
notation in any way suggest that petitioner had “insight” into the nature of her reported
difficulties as Dr. Tornatore suggests. Rather, the notation was limited merely to the
fact of the cognitive complaint. 9
9 Critical to Dr. Tornatore’s assessment of the statements at issue are their juxtaposition against other
statements in the same record. Specifically, the record states: “. . . CI reports she continues to struggle
with the grief related to the loss of her sister and cous[in] approximately a year ago. CI states ‘I think they
know something is wrong where I work. I cried the other day but did not let anyone see.’ CI report
‘cloudy thoughts’ and ‘not being able to get it together.’ CI shows pattern of high expectation of herself in
multiple areas of her life. CI reports that she is going to make the church she is going to her home church
. . .” (Ex. 5, p. 23.) Dr. Tornatore specifically links the statement regarding crying at work to the
statements regarding cloudy thoughts; however, given the scope of the reports summarized without
transitions in just a few short sentences in this and other session records, Dr. Tornatore is not persuasive
in suggesting that the sentence reporting an episode of crying at work must necessarily be related to the
following sentence relating to the clarity of her thoughts.
22
Further, petitioner’s overall medical records do not clearly reflect the distinction
Dr. Tornatore raises between petitioner’s pre- and post-vaccination cognitive
complaints. Whereas the reference to “cloudy thoughts” and “not being able to get it
together,” are an isolated instance within the therapy record, this complaint was made
only one month prior to what petitioner otherwise contends became an ongoing pattern
of memory loss. In fact, petitioner’s first report of post-vaccination symptoms on
October 27, 2014, employed language very similar to the prior therapy record in
reporting that petitioner “can’t think.” (Ex. 6, p. 2.) It was not until she returned for follow
up that this was specifically noted to be an issue of memory. (Id. at 3 (“memory still
bothersome”).) Moreover, consistent with “cloudy thoughts” and “not being able to get it
together,” when petitioner later presented for a vocational assessment, she was noted
to have both memory impairment and executive function difficulty. (Ex. 24.) Thus, even
if petitioner subjectively believed at the time that she was reporting grief related
cognitive difficulties to her therapist in September of 2014, Dr. Evans is persuasive in
suggesting that there is little to no medical basis for parsing petitioner’s earliest
cognitive complaints from her later cognitive complaints. (Tr. 252-53.)
For all these reasons, Dr. Tornatore is not persuasive in suggesting that the
notations in petitioner’s contemporaneous therapy records demonstrate her pre-
vaccination cognitive complaints to be of a distinctly different character. Thus, Dr.
Tornatore is not persuasive in dismissing petitioner’s pre-vaccination report of “cloudy
thoughts” and “not being able to get it together” as a separate pseudodementia
unrelated to her subsequent cognitive complaints.
b. Loving prong two
The second Loving prong examines petitioner’s post-vaccination condition. In
order for petitioner’s preferred explanation of events to be likely, she must
preponderantly prove three underlying points with respect to her post-vaccination
condition. First, she must establish that she does suffer epilepsy. Second, if she does
suffer epilepsy, then she must establish that onset of any seizure disorder was after the
time of the acute-post-vaccination cerebral vascular event that allegedly caused it.
Third, and relatedly, she must demonstrate that she actually suffered an acute
cardiovascular event.
i. Epilepsy
On September 8, 2015, petitioner underwent EEG which was abnormal due to
sharp waves concerning for an epileptogenic focus. (Ex. 10, p. 10.) Dr. Thomas initially
suspected subclinical seizures and later records accept a history of focal epilepsy. (Ex.
12, p. 10; Ex. 28, p. 10.) Thus, Dr. Tornatore endorses a seizure disorder. (Tr. 12.)
Respondent disputes that any epilepsy diagnosis is preponderantly established (ECF
No. 60, pp. 10-12); however, his own expert agrees that petitioner’s EEG demonstrated
epileptic discharges and that “I don’t disagree with the clinician’s diagnosis of possible
subclinical seizures causing memory problems. That’s typical. Memory loss is very
commonly associated with epilepsy.” (Tr. 219.) Although Dr. Evans has significant
23
doubts that there is sufficient clinical evidence to confirm the diagnosis, he agrees that it
is “more than possible” and “quite plausible.” (Tr. 219-21.)
In light of all of the above, while it is not certain that petitioner suffers epilepsy, I
conclude that petitioner has established that there is preponderant evidence that she
suffers left temporal focal epilepsy.
ii. Epilepsy/seizure onset
Although the fact of petitioner’s epilepsy is preponderantly established, a post-
vaccination seizure onset is not. As noted above, petitioner’s epilepsy was first
documented in connection with her September 8, 2015 EEG, about a year post-
vaccination. (Ex. 10, p. 9.) At that time, it was viewed as a possible explanation for her
memory problems dating back earlier. (Ex. 12, p. 10.) In that regard, both Dr.
Tornatore and Dr. Evans agree. (Tr. 35-36, 107, 219.)
However, Dr. Evans explained that the discharges seen on EEG are only
biomarkers of epilepsy. They are not evidence of seizures in themselves. (Tr. 223.)
Moreover, while seizures typically include temporary amnesia during the seizure and
post-ictal period, permanent memory loss like that displayed by petitioner would take
“lots and lots of seizures over years” and it “doesn’t happen overnight or quickly.” (Id. at
223-24.) Thus, even accepting arguendo that her memory complaints began shortly
after vaccination, her epilepsy would have begun much earlier. Additionally, for the
reasons discussed under Loving prong one, above, petitioner actually began
complaining of cognitive concerns no later than about a month prior to her vaccination.
All of this strongly suggests that, if petitioner had epilepsy-related permanent memory
loss as alleged, then the epilepsy must have been chronic and preexisted her
vaccination.
Dr. Tornatore cites petitioner’s hand spasms, which were first documented post-
vaccination, as evidencing seizure activity. (Tr. 28, 101-03.) However, petitioner’s own
treating physician, Dr. Buechel, specifically opined that the hand spasms were not
related to seizures. (Ex. 28, p. 32.) Furthermore, Dr. Evans persuasively explained that
the hand spasms are not consistent with petitioner’s EEG, because they manifested
bilaterally. 10 (Tr. 210-12.) The focal discharges evidenced by the EEG would not result
in bilateral symptoms and in the absence of other symptoms, bilateral hand movements
“is not a seizure semiology.” (Id. at 212.) It would also be unusual for petitioner to be
aware of her hand spasming if they were in fact seizures, because seizures generally
involve temporary amnesia. (Tr. 223.) This latter point also appears to have partly
informed Dr. Buechel’s opinion. (Ex. 28, p. 32.)
10 Petitioner’s separate symptom of right hand cramping could potentially be consistent with left focal
discharges insofar as the bilateral presentation would not be an issue (Tr. 216-17); however, the other
issues would remain and petitioner’s treating physician felt this was due to “organic writer’s cramp.” (Ex.
28, p. 35.)
24
In light of all of this, there is not preponderant evidence that petitioner ever
suffered a clinically apparent seizure, meaning her epilepsy only ever consisted of
subclinical seizures. It is therefore not possible to identify the initial onset of the
epilepsy on this record. However, to the extent the epilepsy is viewed as the cause of
petitioner’s memory problems, this would likely place the onset of epilepsy prior to the
vaccination at issue, especially, but not only, because of the analysis of petitioner’s
cognitive complaints under Loving prong one.
iii. Acute cerebrovascular event
One of petitioner’s treating physicians, Dr. Thomas, questioned whether
petitioner may have experienced an acute cardiac episode such as a stroke or
hypertensive event. (Ex. 12, p. 17.) This was not based on any direct evidence, but
rather upon the seeming coincident nature of petitioner’s post-vaccination illness and
her reports of cognitive complaints. (Id.) The assessment was first notated prior to
petitioner undergoing the MRI study that Dr. Thomas would later interpret as being
within normal limits for age. (Id. at 10.) The majority of petitioner’s treating physicians,
including her other neurologists, offered no such opinion. Apart from her reported
cognitive complaints, petitioner never presented for care with symptoms of a stroke. (Tr.
236-39, 246-48.) Based on Dr. Evan’s assessment, a stroke would be implausible
given petitioner’s history. (Id. at 249.)
Nonetheless, Dr. Tornatore applies the same reasoning as Dr. Thomas. During
the hearing, Dr. Tornatore acknowledged that petitioner’s MRI scan itself is incapable of
detecting whether any acute event had previously happened. (Id. at 20.) Rather, to the
extent it is interpreted abnormal at all, it reflects only chronic changes. However, he felt
the abrupt timing of onset of petitioner’s seizures and memory problems following
petitioner’s constitutional symptoms supported the existence of an acute cardiovascular
event. (Id. at 56-58.) Following resolution of the above-discussed facts, this opinion is
not tenable.
Because petitioner’s epilepsy was only ever subclinical, there is no evidence to
support that a seizure disorder began after petitioner’s constitutional symptoms. To the
extent her cognitive complaints are attributable to epilepsy, there is also not
preponderant evidence clearly placing onset of those cognitive complaints post-
vaccination as petitioner alleges. Without persuasive evidence supporting Dr.
Tornatore’s preferred coincident timing, there is no basis to speculate that any acute
cardiovascular episode ever occurred. Dr. Tornatore acknowledged that the type of
cognitive difficulties at issue in this case can be the result of accumulated damage. (Tr.
74.) Thus, even if petitioner had demonstrated her preexisting microvascular
angiopathy to have been clinically significant, and even if it were a contributor to
petitioner’s epilepsy (a point Dr. Evans would dispute (Tr. 275)), this would still not imply
the presence of any acute cerebrovascular event.
Furthermore, Dr. Tornatore acknowledged that, to the extent he characterizes
acute ischemia as a stroke, if a stroke occurred, it was a “small” stroke. (Tr. 65.)
25
However, Dr. Evans explained that typically when a minor stroke causes later epilepsy,
the epilepsy arises months after the stroke. (Tr. 226.) In order for a stroke to acutely
cause epilepsy as proposed by Dr. Tornatore, it would most likely have to be of a
severity that would be “obvious” and detectable on MRI, even an MRI performed as
remotely as the MRI available in this case. (Tr. 226-29, 240, 245.)
c. Loving prong three
Under Loving prong three, a comparison of the pre- and post-vaccination
conditions examined under the first two prongs must indicate that petitioner has
experienced a change for the worse in her pre-existing condition which results in
markedly greater disability, pain, or illness accompanied by substantial deterioration of
health. § 300aa-33(4). This aspect of the analysis does not reach the question of
vaccine-causation and petitioner is not obligated to show that her outcome is worse
than the expected outcome for a person with her condition. Sharpe v. Sec’y of Health &
Human Servs., 964 F.3d 1072, 1081-82 (Fed Cir. 2020).
In this case, petitioner’s claim is that she ultimately suffers cognitive issues
related to epilepsy. It is beyond meaningful dispute that petitioner’s cognitive condition
is worse post-vaccination than it was pre-vaccination. However, the pre-existing
condition petitioner alleges to have been worsened is her alleged asymptomatic
microvascular angiopathy. Thus, based on petitioner’s framing of the issues in this
case, Loving prong three turns on whether petitioner has shown that her alleged
epilepsy is a sequela of her cardiovascular health. (In her brief, petitioner characterizes
this as whether her preexisting microvascular angiopathy “evolved into” epilepsy. (ECF
No. 56, p. 11).)
While epilepsy can be a sequela to ischemic disease, that is certainly not the
only cause and new onset of epilepsy in adults is “not rare.”11 (Ex. A, pp. 6-8.) Dr.
Tornatore’s opinion is based on the “striking” nature of petitioner’s clinical presentation
and his assertion that “it doesn’t make sense” that petitioner’s post-vaccination
constitutional symptoms (i.e. her diagnosed viral syndrome) and cognitive complaints
would arise at the same time, but be unrelated. (Tr. 56-57.) Here, however, a
comparison of the separate analyses discussed relative to Loving prongs one and two
above finds that petitioner has not preponderantly shown that this striking coincidence
occurred or that her epilepsy is related to any prior microvascular angiopathy
First, petitioner has not preponderantly shown either under Loving prong one that
her preexisting microvascular disease was clinically significant in the first place or under
Loving prong two that she suffered any acute cardiovascular event following her
vaccination. While Dr. Evans agrees that either stroke or “extensive” ischemic disease
can cause epilepsy, he explained that a mild chronic small vessel ischemic disease is
not associated with epilepsy. (Tr. 275; Ex. CC, pp. 2-3.)
11Petitioner did report a family history of epilepsy. (Ex. 28, p. 32; Ex. 12, p. 15 (noting petitioner has a
brother who had epilepsy since childhood).)
26
Second, petitioner has not demonstrated under Loving prong one she was free of
cognitive difficulties pre-vaccination nor under Loving prong two that she suffered overt
seizures post-vaccination. Thus, the actual onset of her epilepsy, which has remained
subclinical, is unknown, and may well have begun prior to vaccination.
For these reasons, petitioner has not preponderantly demonstrated that her
cerebrovascular health deteriorated post vaccination nor that her epilepsy was caused
by any post-vaccination acute cerebrovascular event. Thus, petitioner’s epilepsy and its
consequences do not constitute a significant aggravation of microvascular angiopathy.
Petitioner therefore has not preponderantly satisfied her burden under Loving prong
three.
d. Althen prong one/Loving prong four
i. Petitioner’s burden of proof
Petitioner’s burden under the first Althen prong/fourth Loving prong is to provide,
by preponderant evidence, “a medical theory causally connecting the vaccination and
the injury.” Althen, 418 F.3d at 1278. Such a theory must only be “legally probable, not
medically or scientifically certain.” Knudsen v. Sec’y of Human & Health Servs., 35 F.3d
543, 548-49 (Fed. Cir. 1994). Moreover, scientific evidence offered to establish Althen
prong one is viewed “not through the lens of the laboratorian, but instead from the
vantage point of the Vaccine Act's preponderant evidence standard.” Andreu v. Sec’y of
Health & Human Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009). However, to satisfy this
prong, petitioner’s theory must be based on a “sound and reliable medical or scientific
explanation.” Knudsen, 35 F.3d at 548; Boatmon, 941 F.3d at 1359. Petitioner’s burden
under Loving prong four varies from her burden under Althen prong one in that a
significant aggravation claim requires petitioner only to show that the vaccine at issue
can worsen the condition at issue rather than being its cause. Sharpe, 964 F.3d at 1083
(explaining that “[u]nder Loving prong 4, a petitioner need only provide ‘a medical theory
causally connecting [petitioner]’s significantly worsened condition to the vaccination.’ In
other words, Petitioner was required to present a medically plausible theory
demonstrating that a vaccine ‘can’ cause a significant worsening of [petitioner’s injury].”)
Petitioner’s prehearing brief includes a recitation of the applicable legal standard
comparable to the above. However, she urges that her burden under Althen prong
one/Loving prong four is specifically limited to a showing of “biologic plausibility” based
on a more recent Court of Federal Claims decision. (ECF No. 56, p. 10 (quoting J. v.
Sec’y of Health & Human Servs., 155 Fed. Cl. 20, [pin pg] (2021).) In sum, petitioner
argues that in 2009 the Federal Circuit in Andreu articulated “biological plausibility” as
the standard for evaluating a theory pursuant to Althen prong one and that this
articulation has never been overturned. 12 (ECF No. 56, p. 10.) Importantly, however,
12A subsequent Court of Federal Claims decision has come to a different conclusion following a review of
the same prior precedents. K.A. v. Sec’y of Health & Human Servs., 164 Fed. Cl. 98, 125-26 (2022)
(characterizing petitioner’s reliance on a “biologically plausible” standard as an attempt to “refashion the
27
this does not indicate that a theory must be couched or addressed specifically by that
terminology. The Federal Circuit has explained in Knudsen that “[c]ausation in fact
under the Vaccine Act is thus based on the circumstances of the particular case, having
no hard and fast per se scientific or medical rules.” 35 F.3d at 548. Regardless of the
specific reference to “biologic plausibility,” the Federal Circuit’s decision in Andreu
explains that a petitioner’s burden is to provide a theory “supported by a ‘reputable
medical or scientific explanation.’” 569 F.3d at 1379 (quoting Althen, 418 F.3d at 1278).)
The Circuit further explained that the assessment of whether a theory is reputable “can
involve assessment of the relevant scientific data” but stressed that such an
assessment must be based on preponderant evidence as contrasted against the type of
“very near certainty – perhaps 95% probability” generally required by medical research.
(Id. at 1380.) Nothing in Andreu implies that the “biologically plausible” theory
presented in that case constituted anything less than preponderant evidence or that a
theory that is not “sound and reliable” could be considered “biologically plausible.”
While scientific certainty is clearly not required, the Federal Circuit has also repeatedly
held that theories that are “plausible,” as in merely “possible,” do not meet petitioner’s
preponderant burden of proof. Boatmon, 941 F.3d at 1360.
ii. Application to Dr. Tornatore’s opinion
During the hearing, Dr. Tornatore summarized his causal opinion as follows:
“[P]etitioner had underlying microvascular angiopathy as seen by her MRI . . . there was
a [flu] vaccination that she received . . . that resulted in cytokine and chemokine release,
which in turn led to small vessel changes . . . leading to either contraction or frank
ischemia in the small [] blood vessels, which led to a scar, which in turn led to neuronal
irritability, and then the more permanent seizure disorder thereafter with the memory
and the cognitive issues being part of the symptomology.” (Tr. 35-36.) In other words,
Dr. Tornatore’s theory of vaccine causation is that the cytokine response to vaccination
can cause cardiovascular changes resulting in stroke. 13 Stroke, in turn, can then
explain this petitioner’s clinical history.
Several of the points contributing to Dr. Tornatore’s theory are not disputed. Dr.
Evans agrees that epilepsy can cause permanent memory loss. (Tr. 219, 223.) He also
agrees that a stroke can cause epilepsy. (Id. at 224.) In fact, he characterizes it as
“very common.” (Id.) Further, Dr. Evans agrees that strokes are associated with
inflammation. (Id. at 259-60.) The question on which the experts disagree is whether
the flu vaccine itself can cause or trigger a stroke. (Id. at 262-63.)
first Althen prong standard” and citing approvingly to the “sound and reliable” language included in the
Federal Circuit’s Boatman decision).
13 During cross-examination, Dr. Tornatore seemed to characterize his opinion as being based on either
“ischemic events or strokes.” (Tr. 64.) However, he also provided testimony suggesting that he is using
the terms interchangeably, stating “any way you look at it, this is vascular disease, and it would be
considered a stroke.” (Tr. 65.) Asked if his opinion is that petitioner had “an acute stroke,” he answered
“Yes, I think there was an acute event that happened . . .” (Tr. 67.) On further questioning he indicated
that stroke is “too generic” and that “vascular event” gets closer to what he opines happened; however,
he was clear in expressing that his theory requires an event causing permanent damage, as opposed to a
hypertensive urgency or PRES, which were also referenced by Dr. Thomas. (Tr. 172-78.)
28
As a starting point, Dr. Tornatore relies on a 2002 review article by Libby, et al.,
positing a relationship between inflammation and atherosclerosis (i.e. the deposition of
fatty plaques on artery walls). (Libby et al., supra, at Ex. 18.) The authors suggest that
atherosclerosis should not be viewed merely as a bland lipid storage disease. (Id. at 1.)
Instead, they conclude that “[c]urrrent evidence supports a central role for inflammation
in all phases of the atherosclerotic process.” (Id. at 7.) The authors further suggest that
“[c]irculating acute-phase reactants elicited by inflammation may not only mark
increased risk for vascular events, but in some cases may contribute to their
pathogenesis.” (Id.) This is characterized as being a “new insight” at the time. (Id.)
Importantly, however, this paper discusses inflammation as arising in the context of
otherwise accepted risk factors for cardiovascular disease, including obesity,
hypertension, diabetes, and infection. (Id. at 3-4.) Notwithstanding his citation to outlier
cases, Dr. Tornatore acknowledged that for most patients there is a difference in the
potency of the immune response to vaccination as compared to infection and that
infection would be a more likely cause of the type of inflammatory cascade he proposes.
(Tr. 145, 158.) Nothing in the Libby, et al., paper implicates vaccinations broadly or the
flu vaccine specifically as a cause of stroke.
In contrast, it is undisputed that the flu vaccine has been shown epidemiologically
to have a cardio-protective effect. (Armin J. Grau et al., Influenza Vaccination is
Associated with a Reduced Risk of Stroke. 36 STROKE 1501 (2005) (EX. 32); Nichols et
al., supra, at Ex. EE; Philippa Lavallee et al., Association Between Influenza
Vaccination and Reduced Risk of Brain Infarction, 33 STROKE 513 (2002) (Ex. DD).)
This is not dispositive, but provides some important context. Accord Baldwin v. Sec’y of
Health & Human Servs., No. 13-957V, 2020 WL 4197937, at n. 14 (Fed. Cl. Spec. Mstr.
June 4, 2020) (explaining that because influenza infection is associated with increased
deaths from cardiovascular disease “assessment of the true significance of this
epidemiologic evidence [is] very difficult. Accordingly, epidemiologic evidence of a
cardio protective effect from the influenza vaccine, though relevant, is not in itself
dispositive”), mot. rev. denied, 151 Fed. Cl. 431 (2020). The Federal Circuit has
previously stressed that a petitioner is not obligated to present an epidemiological case
supporting her claim. Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317,
1325 (Fed. Cir. 2006). Nonetheless, “[n]othing in Althen or Capizzano requires the
Special Master to ignore probative epidemiological evidence that undermines
petitioner’s theory.” D'Tiole v. Sec’y of Health & Human Servs., 726 F. App’x 809, 811
(Fed. Cir. 2018) (citing Andreu, 569 F.3d at 1379 (“Although Althen and Capizzano
make clear that a claimant need not produce medical literature or epidemiological
evidence to establish causation under the Vaccine Act, where such evidence is
submitted, the Special Master can consider it in reaching an informed judgment as to
whether a particular vaccination likely caused a particular injury.”).
Set against the lack of epidemiologic support for this theory, Dr. Tornatore
provides three studies seeking to establish that the flu vaccine does create a cytokine
response that can vary depending on individual characteristics, such as age or pre-
existing conditions. (Carty et al., supra at Ex. 20; McDonald et al., supra, at Ex. 19;
29
Talaat et al., supra, at Ex. 35.) However, none of these studies demonstrates that this
cytokine response leads to relevant adverse events. Of the three, only Carty et al.,
specifically examined cardiovascular health, comparing post-vaccination cytokine levels
in those with preexisting carotid artery disease against controls without the disease.
Although the group with preexisting disease had higher cytokine levels, individuals from
both groups had “mild, but measurable” levels. Additionally, the authors did not record
any adverse events attributable to elevated cytokine levels for either group. (Carty et
al., supra, at Ex. 20, p. 1 (abstract).) McDonald, et al., focused on vaccine efficacy
using a mouse model. (McDonald et al., supra, at Ex. 19.) Talaat, et al., reported an
association between adverse events and cytokine levels post-vaccination. However,
the adverse events examined were non-severe and are in no way comparable to what is
hypothesized in Dr. Tornatore’s theory. About half of the subjects in their study reported
either post-vaccination myalgia or injection site pain, which were described most often
as mild. Single subjects reported adverse events such as abnormal sweating
(diaphoresis); sore throat; vomiting; and syncope during a blood draw. (Talaat et al.,
supra, at Ex. 35, p. 5.)
An additional study sought to examine whether response to vaccination could
contribute to endothelial dysfunction that could lead to the risk of cardiovascular events.
(Aroon D. Hingorani et al., Acute Systemic Inflammation Impairs Endothelium-
Dependent Dilatation in Humans, 102 CIRCULATION 994 (2000) (Ex. 33).) Subjects were
administered a vaccination against Salmonella typhi. Subsequently, the subjects were
tested to measure cytokine levels, resistance blood vessel response, and conduit vessel
response. The results showed a progressive rise in cytokines, but with no effect on
blood pressure, resting heartrate, or baseline forearm blood flow. (Id. at 2.)
Nonetheless, the results showed “profound, but temporary, suppression of endothelium-
dependent relaxation in the forearm circulation. These findings demonstrate that even a
relatively mild systemic inflammatory response is associated with significant alteration in
endothelial function of a type commonly thought to be associated with increased
cardiovascular risk.” (Id. at 3.) The authors explained, however, that the mechanism by
which inflammation may be acting to impair endothelium-dependent relations is not
understood and would require further study. (Id. at 5-6.) Moreover, the authors
acknowledge that the systemic inflammation that has been implicated by infective
disorders is “far more severe and long lasting.” Although the study demonstrates that
even mild inflammation disturbs endothelial regulation, it is yet to be determined
whether the observations of the study are seen in a clinical context. (Id.)
Apart from these studies, Dr. Tornatore presents two case reports of stroke
following influenza vaccination. “[C]ase reports ‘do not purport to establish causation
definitively, and this deficiency does indeed reduce their evidentiary value’…. [but] ‘the
fact that case reports can by their nature only present indicia of causation does not
deprive them of all evidentiary weight.’” See Paluck v. Sec'y of Health & Human Servs.,
104 Fed. Cl. 457, 475 (2012) (quoting Campbell v. Sec'y of Health & Human Servs., 97
Fed. Cl. 650, 668 (2011), aff’d 786 F.3d 1373 (Fed. Cir. 2015)).
30
In the first case report, the authors reported on a 75-year-old male who suffered
posterior circulation ischemia after receiving an H1N1 flu vaccination. (Lin et al., supra,
at Ex. 21).) The patient began experiencing episodes of spontaneously resolving
dizziness and unsteady gait on the left side beginning about seven hours after
vaccination. He did not seek care until seven days later when MRI showed indications
of new infarctions. The authors acknowledge that “[t]he causal relation between
vaccination and ischemic stroke is seriously challenged . . . especially when our patient
does have a few stroke risk factors, such as hypertension, previously stroke, intracranial
atherosclerosis, old age, and hypertriglyceridemia.” (Id. at 2.) The authors hypothesize
that “an inflammatory/immunological response after vaccination may trigger thrombosis
superimposing a pre-existing prothrombotic state (Id. at 1 (abstract)), but ultimately
acknowledge that “it is uncertain if an enhancement of inflammatory/immunological
activity after vaccination is sufficient for initiating symptomatic vascular occlusion” (Id. at
4).
In the second case report, Thoon and Chan report on a 10-year-old child who
suffered a cerebellar stroke one day after receiving the seasonal trivalent influenza
vaccine. (Thoon & Chan, supra, at Ex. 31.) Contrasting this case against limited prior
case reports involving older individuals with other stroke risk factors, the authors note
that their evaluation of this patient did not reveal any underlying prothrombotic
conditions. (Id. at 4.) Contrasting this case against limited prior case reports involving
post-vaccination stroke in children, this patient did not have any imaging consistent with
cerebral angiopathy to explain the nature of the ischemic stroke. (Id.) The authors
ultimately conclude that “[t]he close temporal relationship between an ischemic stroke in
an otherwise healthy 10-year-old child with recent receipt of seasonal influenza
vaccination may be entirely coincidental, and does not alter our stance in
recommencing the influenza vaccination for all children, especially those at risk of
developing complications from an influenza infection.” (Id. at 4-5.)
In sum, petitioner has provided some evidence to suggest a possible role for
mostly chronic or infection-related inflammation in contributing to stroke. Petitioner has
also provided some experimental evidence to suggest that at least one vaccine not at
issue in this case - Salmonella typhi – can affect human blood vessels to at least some
degree in an experimental context, though the actual clinical significance of that finding,
if any, is unclear. Further to that, petitioner has presented some evidence to support the
uncontroversial point that the flu vaccine produces an inflammatory cytokine response,
but without any evidence this results in relevant adverse events. Thus, evidence
directly suggesting that a flu vaccination itself can result in stroke consists only of two
tentative and unsimilar case reports set against epidemiologic data that fails to detect
the flu vaccine as carrying a risk for stroke.
Considering all of this collectively and in the context of the record as a whole, I
conclude that this is inadequate to preponderantly establish that the flu vaccine can
cause a worsening of preexisting microvascular angiopathy leading to or otherwise
causing stroke or other acute ischemic event. Thus, petitioner has not preponderantly
satisfied Althen prong one/Loving prong four.
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e. Althen prong two/Loving prong five
The second Althen prong/fifth Loving prong requires proof of a logical sequence
of cause and effect showing that the vaccine was the reason for the injury, usually
supported by facts derived from a petitioner's medical records. Althen, 418 F.3d at
1278; Andreu, 569 F.3d at 1375-77; Capizzano., 440 F.3d at 1317, 1326; Grant, 956
F.2d at 1148. However, medical records and/or statements of a treating physician do
not per se bind the special master to adopt the conclusions of such an individual, even if
they must be considered and carefully evaluated. See 42 U.S.C. §300aa-13(b)(1)
(providing that “[a]ny such diagnosis, conclusion, judgment, test result, report, or
summary shall not be binding on the special master or court”); Snyder v. Sec’y of Health
& Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (stating that “there is nothing . . . that
mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted”).
In this case, analysis of Althen prong two/Loving prong five begins with
petitioner’s initial post-vaccination illness. On October 27, 2014, petitioner presented for
care at a community clinic with a complaint of six days of illness consisting of loss of
appetite, cough, fever and “no energy,” but with no sore throat. (Ex. 6, p. 2.) It was
noted as part of the history that this illness arose about three hours after her flu
vaccination, however, she was diagnosed as having a “viral syndrome.” (Id.) Petitioner
returned for follow up twice and the diagnosis of viral syndrome was never altered. (Id.
at 3-4.) Significantly, a vaccine reaction was questioned (“flu vaccine?” listed with
allergies (Ex. 6, p. 5)), but a viral syndrome with complications was instead diagnosed
(Id.). According to Dr. Tornatore, this episode should be revisited as a cytokine
response to vaccination. (Tr. 27-30.) Dr. Tornatore suggests that, in severe cases, a
cytokine response to vaccination can mimic a viral infection. (Id. (citing L’Huillier et al.,
supra, at Ex. 34).) However, the L’Hullier paper he cites for this point examines only
cytokine levels and does not address the symptoms associated with a cytokine
response to vaccination. (L’Huillier et al., supra, at Ex. 34.)
In petitioner’s case, Dr. Tornatore focuses on constitutional symptoms of fever
and chills as well as local injection-site swelling as being consistent with a cytokine
response. (Tr. 27-30.) Importantly, however, petitioner’s actual treatment records for
this illness did not record the injection site swelling she later included in her affidavit
account. (Compare Ex. 6 (treatment records) and Ex. 25 (petitioner’s affidavit).)
Petitioner did not report that her arm swelled until she sought care from Dr. Thomas in
August of 2015, about ten months post-vaccination. (Ex. 12, p. 15.) However, the
records reflect that petitioner’s account had changed in multiple ways over time, tending
toward petitioner’s subjective belief that her vaccination was ultimately responsible for
her circumstances. For example, at the time petitioner first presented to Dr. Thomas in
August of 2015 and thereafter, she indicated that her post-vaccination illness had
resulted in her being fired for being unable to do her job. (Ex. 12, p. 15.) However, in
her more contemporaneous therapy records she discussed both her firing and her post
vaccination illness without linking the two, instead attributing her firing to “politics”
related to an interpersonal conflict at work. (Ex. 5, p. 25.) Additionally, the
32
hallucinations and visual changes she would later retrospectively report beginning in the
summer of 2015 were not documented in any of petitioner’s medical records from the
autumn of 2014. (Exs. 5-6.) Thus, Dr. Tornatore’s assumption of injection site swelling
as a tell-tale of a vaccine reaction, for which there is no contemporaneous evidence, is
not well supported. See e.g., R.K. v. Sec’y of Health & Human Servs., No. 03-632V,
2015 WL 10936124, at *76 (Fed. Cl. Spec. Mstr. Sept. 28, 2015) (holding that more
remote histories of illness do not have sufficient indicia of reliability to be credited over
conflicting contemporaneous medical records and earlier reported histories), mot. rev.
denied 125 Fed Cl. 57 (2016), aff’d 671 Fed. Appx. 792 (Fed. Cir. 2016); see also e.g.,
Vergara v. Sec’y of Health & Human Servs., 08-882V, 2014 WL 2795491, *4 (Fed. Cl.
Spec. Mstr May 15, 2014) (“Special Masters frequently accord more weight to
contemporaneously-recorded medical symptoms than those recorded in later medical
histories, affidavits, or trial testimony” (emphasis added).).
Nor does Dr. Tornatore persuasively account for the fact that both petitioner’s
contemporaneous medical record and her own affidavit confirm that her core symptoms
included cough. (Ex. 6, p. 2; Ex. 25, p. 2.) Dr. Evans, by contrast, testified that
petitioner’s cough is consistent with a viral illness, but not a vaccine reaction. (Tr. 256.)
Dr. Tornatore relies on the prescribing information (“package insert”) for the Fluzone
Quadrivalent vaccine as support for the notion that a cough could be consistent with a
vaccine reaction. (Tr. 278-79; Ex. 36.) The package insert lists adverse reactions for
four different age groups. For none of the groups is either cough or any upper
respiratory complaint listed as an adverse reaction. For adults the most common
adverse events were injection site pain, myalgia, headache, and malaise. (Ex. 36, pp. 6-
7.) Instead, Dr. Tornatore relies on a discussion of the clinical trials for the vaccine.
Specifically, the clinical trials disclose that “cough” was among the most commonly
reported unsolicited non-serious adverse events. (Tr. 279-80; Ex. 36, p. 11.)
Importantly, however, the package insert cautions against using the adverse event rates
as reflecting “the rates observed in practice.” (Ex. 36, p. 7.) Additionally, the rates for
each of the listed unsolicited adverse events (headache, cough, and oropharyngeal
pain) is not specified. All that is indicated is that 33 people reported such events and
that this was lower than what was reported among either of the two control groups who
received different vaccines. (Id. at 15.) Nothing in the document suggests that any
significance was found in the reports of cough. Thus, for example, cough was not
observed as an adverse event in the Talaat study that Dr. Tornatore relied upon to
support his theory that vaccine-related inflammation can lead to acute cardiovascular
events. (Talaat et al, supra, at Ex. 35, p. 5.) Moreover, nothing in the document
explains whether these reports of cough occurred in the context of broader illnesses
such as what petitioner experienced.
Both of these points – the cough and the failure to initially report injection site
swelling - accord with the diagnosis of the treating physician, who considered, but
rejected, a vaccine reaction in favor of a diagnosis of viral syndrome. There is therefore
not preponderant evidence that petitioner’s contemporaneous diagnosis of a viral
syndrome should be set aside in favor of an undiagnosed post-vaccination cytokine
response. Absent this, Dr. Tornatore’s theoretical causal chain is broken with respect to
33
any link to vaccination regardless of the resolution of any of the other factual issues in
the case. In that regard, Dr. Tornatore agrees that an infection would be capable of
setting off the series of events underlying his theory of causation. (Tr. 157.) Similarly,
Dr. Evans has opined that, even if petitioner did suffer epilepsy beginning shortly after
her these events, it is more likely that it was brought on simply by the infection
documented in her medical records. (Ex. A, p. 8.)
Additionally, as explained under Loving prong three, temporal lobe epilepsy
occurs in the absence of any ischemia. Moreover, for the reasons explained under
Loving prong one, it is not clear that petitioner’s minimal, age-related MRI changes are
indicative of any meaningful ischemic disease. And, as explained under Loving prong
two, there is not preponderant evidence petitioner suffered an acute cerebrovascular
event. And, in any event, petitioner’s epilepsy more likely predated either her
vaccination or her alleged acute cerebrovascular event. Thus, there is little linking
petitioner’s epilepsy to her cardiovascular health other than Dr. Tornatore’s say-so,
which is based on assumptions that are not supported by preponderant evidence.
Burns v. Sec’y of Health & Human Servs., 3 F. 3d 415 (Fed. Cir. 1993) (holding that
“[t]he special master concluded that the expert based his opinion on facts not
substantiated by the record. As a result, the special master properly rejected the
testimony of petitioner's medical expert.”); see also Rickett v. Sec’y of Health & Human
Servs., 468 Fed. Appx. 952, 958 (Fed. Cir. 2011) (holding that “it was not error for the
Special Master to assign less weight to Dr. Bellanti's conclusion regarding challenge-
rechallenge to the extent it hinged upon Mr. Rickett's testimony that was inconsistent
with the medical records.”); Dobrydnev v. Sec’y of Health & Human Servs., 566 Fed.
Appx. 976, 982–83 (Fed. Cir. 2014) (holding that the special master was correct in
noting that “when an expert assumes facts that are not supported by a preponderance
of the evidence, a finder of fact may properly reject the expert's opinion”) (citing Brooke
Group Ltd. v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993)); Bushnell
v. Sec'y of Health & Human Servs., No. 02-1648V, 2015 WL 4099824, at *12 (Fed. Cl.
Spec. Mstr. June 12, 2015) (finding that “because Dr. Marks' opinion is based on a false
assumption regarding the onset of J.R.B.'s condition, and the incorrect assumption of a
“stepwise regression” after each vaccine administration, it should not be credited.”)
These factors prevent petitioner from preponderantly establishing that any logical
sequence of cause and effect links her vaccination to her alleged injury based on Dr.
Tornatore’s opinion. Although parts of this analysis call upon the prior discussion of
Loving prongs one through three, for the reasons discussed in this section, these same
factors prevent petitioner from meeting her burden of proof under either a Loving or
Althen analysis. That is, petitioner has failed to show that she suffered an initial post-
vaccination reaction. She has also failed to show in turn that her vaccine thereby either
significantly aggravated any preexisting microvascular disease or acted in concert with
her cardiovascular risk factors to cause-in-fact an acute cerebrovascular episode. And,
under either approach, she has not preponderantly linked her epilepsy to her
cardiovascular health or identified any clear onset of seizures that could place her
alleged seizure disorder as occurring post-vaccination.
34
Of all the treating physicians that cared for petitioner, only Dr. Thomas expressed
any opinion that is consistent with Dr. Tornatore’s opinion. Specifically, Dr. Thomas
took a history from petitioner that included bilateral hand spasms, hallucinations, and
memory problems, all arising for the first time post-vaccination in the context of
constitutional symptoms such as fever and chills. From that clinical picture, she
suggested a hypertensive urgency or stroke as a possible explanation. (Ex. 12, p. 17.)
Later, she wrote a letter indicating that petitioner should refrain from future flu vaccines
due to a prior severe reaction to flu vaccination. (Ex. 11, p. 1.) However, for all the
reasons discussed throughout this decision, Dr. Thomas’s opinion necessarily suffers all
of the same infirmities as Dr. Tornatore’s. And, like Dr. Tornatore, she was not
petitioner’s treating physician with respect to the initial illness that petitioner has
characterized as a vaccine reaction, but which was diagnosed as a viral illness. On the
whole, petitioner’s treating physicians did not express opinions consistent with either Dr.
Tornatore’s theory specifically or with vaccine causation of petitioner’s condition more
generally.
In light of all of the above, petitioner has not met her preponderant burden of
proof with respect to Althen prong two/Loving prong five.
f. Althen prong three/Loving prong six
The third Althen prong/sixth Loving prong requires establishing a “proximate
temporal relationship” between the vaccination and the injury alleged. Althen, 418 F.3d
at 1281. That term has been equated to the phrase “medically-acceptable temporal
relationship.” Id. A petitioner must offer “preponderant proof that the onset of symptoms
occurred within a timeframe which, given the medical understanding of the disorder's
etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of Health &
Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a
medically acceptable timeframe must also coincide with the theory of how the relevant
vaccine can cause an injury. Id.; Shapiro v. Sec'y of Health & Human Servs., 101 Fed.
Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012), aff'd mem.,
503 Fed. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No. 11-
355V, 2013 WL 3214877, at *26 (Fed. Cl. Spec. Mstr. May 30, 2013), aff'd, 773 F.3d
1239 (Fed. Cir. 2014).
Here, Dr. Evans is persuasive on two points that defeat petitioner’s claim under
Loving prong six/Althen prong three. First, Dr. Evans is persuasive in explaining that
permanent memory loss due to epilepsy requires repeated seizures occurring over an
extended period. (Tr. 223-24.) Thus, even accepting arguendo that petitioner’s
memory problems began soon after vaccination and in the context of what is discussed
above as a viral illness, this would suggest that her epilepsy and seizure activity, which
were otherwise subclinical, would have begun prior to vaccination. Second, in the
context of a more minor stroke or cerebral vascular accident of the type that would
necessarily be implicated here based on the lack of subsequent MRI evidence, Dr.
Evans explains that the onset of epilepsy usually does not occur until months after the
initiating event. (Tr. 226.) Here, however, Dr. Tornatore places the onset of seizure
35
activity contemporaneous to the alleged cerebral vascular accident in the context of
petitioner’s presentation with constitutional symptoms and memory problems. Even if a
three-hour period of onset is potentially consistent with a cytokine response to
vaccination, petitioner has not established that the temporal relationship between the
allegedly resulting cerebrovascular event and the epilepsy is appropriate.
Thus, petitioner has not met her burden of proof with respect to Althen prong
three/Loving prong six.
VII. Conclusion
Notwithstanding the lack of any definitive diagnosis, there is no question that
petitioner suffers a condition that has profoundly affected her life. She has my
sympathy and I do not question her sincerity in bringing this claim. However, for all the
reasons discussed above, I find that petitioner has not met her burden of proof in this
case. Therefore, this case is dismissed. 14
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
14In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter
judgment accordingly.
36