VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00531
Package ID: USCOURTS-cofc-1_18-vv-00531
Petitioner: Malinda Gibbons
Filed: 2018-04-11
Decided: 2025-12-10
Vaccine: Tdap
Vaccination date: 2016-04-19
Condition: Guillain-Barré syndrome, specifically Miller-Fisher syndrome
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Malinda Gibbons alleged that a Tdap vaccine caused her to develop Guillain-Barré syndrome, specifically the Miller-Fisher variant. She sought compensation under the National Childhood Vaccine Injury Act. The Tdap vaccine was administered on April 19, 2016. Ms. Gibbons reported initial neurological symptoms, including tingling, approximately 26 days later. She was hospitalized and diagnosed with Miller-Fisher syndrome, a subtype of GBS. The primary issue in this case was whether Ms. Gibbons's injury met the Vaccine Act's severity requirement, specifically that it lasted more than six months. Ms. Gibbons argued that residual symptoms such as tingling, fatigue, leg cramps, eye strain, heat sensitivity, and anxiety/depression persisted beyond six months. The Secretary argued that her condition resolved within approximately three months and that later symptoms were attributable to other causes, such as perimenopause and subsequent surgical menopause following the removal of her ovaries. The court reviewed extensive medical records and expert opinions. Ultimately, the court found that Ms. Gibbons did not establish by a preponderance of the evidence that her Miller-Fisher syndrome lasted more than six months. The court noted that her symptoms largely resolved within three months and that later reported issues were not persuasively linked to the vaccine-induced GBS or did not meet the severity threshold. Therefore, her petition for compensation was denied.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_18-vv-00531-0
Date issued/filed: 2026-03-02
Pages: 31
Docket text: PUBLIC DECISION (Originally filed: 12/10/2025) regarding 166 DECISION of Special Master, Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
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Case 1:18-vv-00531-TMD Document 173 Filed 03/02/26 Page 1 of 31
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
MALINDA GIBBONS, *
* No. 18-531V
Petitioner, * Special Master Christian J. Moran
*
v. *
* Filed: December 10, 2025
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner;
Debra A. Filteau-Begley, United States Dep’t of Justice, Washington, DC, for respondent.
PUBLISHED DECISION DENYING COMPENSATION1
Seeking compensation pursuant to the National Childhood Vaccine Injury Act, 42 U.S.C.
§ 300aa–10 through 34 (2018), Malinda Gibbons alleges that a tetanus-diphtheria-acellular
pertussis (“Tdap”) vaccine caused her to suffer a neurologic problem known as Guillain-Barré
syndrome (“GBS”), more specifically the Miller-Fisher syndrome. Ms. Gibbons supports her
claim with opinions from a neurologist, Lawrence Steinman, and a gynecologist, Karen Friday.
She advocated through briefs.
The Secretary opposes an award of compensation. The Secretary relies upon opinions
from a neurologist, Dara Jamieson, and a reproductive endocrinologist, David Frankfurter. He
also advocated through briefs.
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), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted on the website.

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Ms. Gibbons has not established she is entitled to compensation because she has not
established that her Miller-Fisher syndrome lasted more than six months. Thus, she does not
fulfill the Vaccine Act’s requirement that any vaccine-induced injury be severe. Because
severity is a dispositive issue, the question of causation is not reached.
I. Summary of Evidence concerning Ms. Gibbons’s Medical History
A. Before Vaccination
Ms. Gibbons was born in 1969. Exhibit 2 (aff., signed May 14, 2018). Before the
vaccination, she worked as a part-time copywriter. Exhibit 3 (damages aff., signed July 13,
2018) at 1; see also Exhibit 69 (affidavit, filed Sep. 23, 2024) ¶¶ 14-18.
In addition to working as a copywriter, Ms. Gibbons had earned a Master of Science in
oriental medicine with a focus on orthopedics, pain, and women’s health. Exhibit 56 (aff.,
signed Nov. 10, 2022) ¶ 6. She earned this degree in 2002 and in the same year Ms. Gibbons
became licensed as an acupuncturist in California. Exhibit 69 (affidavit) ¶¶ 11-12. In 2015, the
year before the vaccination, she worked approximately five hours per week as an acupuncturist.
Id. at ¶ 19. But, in 2016, before she received the allegedly causal vaccination, she did not work
as an acupuncturist. Id. at ¶ 20.
In January 2013, Ms. Gibbons sought treatment for a bulge in her vagina, pelvic pressure,
urinary frequency and urgency, and incontinence. Exhibit 1 at 13-14. She told her gynecologist
that at times she felt an internal obstruction. After an examination, the gynecologist assessed her
as having a mild cystourethrocele. Id. at 15. A “cystourethrocele” is the protrusion of the
bladder and urethra into the vagina. Dorland’s Illus. Med. Dict. 459 (33rd ed.). The Secretary’s
expert, Dr. Frankfurter, stated that this finding is a sign that Ms. Gibbons was developing a
mature cystic teratoma. Exhibit C at 14-15. A “cystic teratoma” is a type of tumor often found
in the ovaries. See Dorland’s at 457 (defining “cystic”) and 1854 (defining “teratoma”).
In January 2014, Ms. Gibbons emailed her primary care provider, Jay Ferns, telling him
that for several days, she had “numbness and tingling in [her] neck and chin.” Exhibit 1 at 21.
During a January 30, 2014 appointment, Ms. Gibbons stated that these symptoms were
aggravated by stress and alleviated by a hot bath. Id. at 26-27.
She saw another doctor about her three-month history of tingling along her neck and into
her face on March 21, 2014. Exhibit 1 at 60. Although a cervical x-ray detected mild
degenerative disease, this was not considered to be the cause of the problem. Id. at 61-5.2
2 Ms. Gibbons omits the events from 2014 from her brief. See Pet’r’s Br., filed Feb. 2,
2023, at 2. However, as discussed below, the reports about tingling are relevant to assessing
reports of tingling in January 2017.
2

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As noted earlier, Ms. Gibbons was earning income as a copywriter. She estimated that in
April 2016, she was spending about five to six hours per day working on a MacBook. Exhibit 69
(affidavit) ¶ 43.
B. Vaccination, Urinary Problems, and Neurologic Problems: April to August
2016
Ms. Gibbons returned to the office of her primary care provider on April 19, 2016, when
she was 47 years old. She reported that she had “chronic and progressively worsening urinary
urgency and frequency.” Exhibit 1 at 132-33. The doctor prescribed a medication for an
overactive bladder, Sanctura. Id.; see also Dorland’s at 1639 (defining Sanctura), 1942 (defining
trospium chloride). During this appointment, she received the allegedly causative dose of the
Tdap vaccination. Exhibit 1 at 137.
In the next few weeks, Ms. Gibbons continued to complain about and seek medical
attention for her bladder problems. E.g. Exhibit 1 at 150 (email on May 7, 2016), 159-160
(treatment with an internist on May 9, 2016), 172-86 (emergency room treatment on May 9,
2016).
On May 15, 2016, which is 26 days after the vaccination, Ms. Gibbons telephoned her
primary care provider to report that she had “tingling all over body . . . . Yesterday developed
gum tingling, now legs, feet, scalp tingling. Unsteady feeling.” Exhibit 1 at 208-09. These
symptoms are accepted as the initial manifestations of her neurologic problem. See Pet’r’s Br. at
35; Resp’t’s Br. at 35.
Although Ms. Gibbons was experiencing tingling all over her body, her appointment on
May 16, 2016 was with a urologist. Exhibit 1 at 214. The urologist stated that she had urinary
retention of unclear etiology. Id. at 217.
The next day, Ms. Gibbons sought care in an emergency room due to numbness
throughout her body and vertigo. Exhibit 7 at 17. An examination showed reduced sensation in
her upper extremities. Id. at 18. The examination also showed that her tympanic membranes
were bulging. Thus, she was diagnosed with a bilateral ear infection, prescribed antibiotics, and
released. Id. at 20.
On May 18, 2016, Ms. Gibbons reported a two-day history of vertigo and difficulty
walking. Exhibit 1 at 237. Eye movements triggered her vertigo. Id. at 245. Tests revealed an
infection in her urinary tract. She was prescribed lorazepam and amoxicillin. Id. at 253, 257.
Two more days later, the urinary tract infection persisted. Id. at 271. She also reported
to medical personnel in an emergency room that she had vertigo, nausea, vomiting, and whole-
body numbness. She was admitted for further testing. Her motor and strength exams were
normal. Id. at 290-91. However, her deep tendon reflexes were diminished at all sites. Id. at
291. She could not track any movement with her eyes because her eyes were fixed.
A neurologist, Howard Noack, evaluated Ms. Gibbons on May 22, 2016. Ms. Gibbons
could not move her right eye and had moderate movement in her left eye. Her strength,
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sensation, and deep tendon reflexes were normal. Exhibit 1 at 306-07. Dr. Noack did not “know
what to make of diffuse tingling and numbness . . . . [t]hus have asked ophthalmology to take a
look.” Id. at 307. Dr. Noack considered “Miller-Fisher but she has normal deep tendon
reflexes.” Id. The ophthalmologist stated that Ms. Gibbons did not have any meaningful eye
movement. Id. at 307 (May 22, 2016).
In the hospital, Ms. Gibbons’s again experienced urinary retention and a catheter was
placed. Exhibit 1 at 284, 312, 315-16. The May 25, 2016 discharge report included urinary
retention as a problem. Id. at 284. The Secretary comments that the “paresthesias
(tingling/numbness) was not described as an active problem at discharge." Resp’t’s Br. at 21-22.
In her September 23, 2024 affidavit, Ms. Gibbons averred that during the May 2016
hospitalization, she had tingling in her “face, legs, and toes, and cramping in her mid-back.”
Exhibit 69 ¶ 44. Although she was directed to cite any medical record supporting her assertion,
Ms. Gibbons stated that she did not know if these assertions were in her medical records. See id.
As an out-patient, Ms. Gibbons saw a neuro-ophthalmologist, Kenneth Kubis, on June 7,
2016. Exhibit 1 at 472. She reported continued dizziness and difficulty focusing near and far.
On examination, Dr. Kubis observed eye weakness and mild ptosis. Id. at 481. (“Ptosis” is a
medical term for drooping eyelids. Dorland’s at 1527). Dr. Kubis suspected that Ms. Gibbons
might have the Miller Fisher variant and he ordered a test for the GQ1b antibody. Exhibit 1 at
481-82.
Ms. Gibbons saw a neurologist, Vidya Hawkins, on June 15, 2016. Exhibit 1 at 505. She
was experiencing double vision. She also had some difficulty with walking. Dr. Hawkins stated
that Ms. Gibbons could have “atypical MFS.” Id. at 509. Dr. Hawkins recommended a three-
day trial of IVIG.
The laboratory reported that Ms. Gibbons was positive for GQ1b antibodies. Exhibit 1 at
501 (reported date of June 17, 2016).3 The result of this testing is a basis for the diagnosis of
MFV. See Exhibit 10 (Dr. Steinman’s report) at 10; Exhibit A (Dr. Jamieson’s report) at 17.
3 On June 20, 2016, Dr. Hawkins directed his staff to inform the patient “Labs normal.”
Exhibit 1 at 527. But, on June 24, 2016, Dr. Kubis attempted to tell Ms. Gibbons about the
positive test. Id. at 551.
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Miller-Fisher Syndrome4
MFV is “generally considered to be a benign, self-limited illness, and prognosis is
generally quite favorable, with most patients experiencing complete resolution of symptoms and
signs by 6 months.” Exhibit A, Tab 9 (Sejvar) at 602.5
On June 22, 2016, Ms. Gibbons saw a new doctor for increased blood pressure. Exhibit 1
at 531. The notes associated with this visit state that the “working diagnosis is Miller Fisher
variant.” Id. at 533.
A three-day course of IVIG started on June 27, 2016. See Exhibit 1 at 579. When Ms.
Gibbons followed up with Dr. Hawkins, Ms. Gibbons said that the IVIG treatments had helped.
Exhibit 1 at 619-20 (Aug. 2, 2016). Ms. Gibbons reported that she felt 95% back to normal with
improvements in her double vision and balance. Id. at 620. She stated that her problems
worsened in the heat.
Dr. Hawkins diagnosed Ms. Gibbons as suffering from GBS-MFV. However, Dr.
Hawkins did not order any further neurologic treatment. Dr. Hawkins recommended that Ms.
Gibbons see a urologist for her urinary symptoms. Exhibit 1 at 621.
Ms. Gibbons’s statement about this medical record. When asked in this litigation to
explain the problems for which she saw Dr. Hawkins, Ms. Gibbons said that she was having
double vision and difficulty balancing. Exhibit 69 (affidavit) ¶ 45. She stated that her eyes
fatigued easily, and she was experiencing general fatigue. She also stated that she was not
having leg cramps and/or toe cramps. Id.
Another follow up visit occurred on August 9, 2016. This one was with the neuro-
ophthalmologist, Dr. Kubis. Exhibit 1 at 640. She stated that her double vision and ptosis had
resolved in July. She reported that she felt “much better and near normal unless I get overheated
and then I have to sit down.” Id. Dr. Kubis examined her and found that her eye weakness and
ptosis are “now resolved.” Id. at 647. He recommended neurology follow ups as needed.
Ms. Gibbons’s statement about this medical record. Ms. Gibbons stated that around this
time, she was experiencing episodes of double vision that lasted longer than one minute, once or
twice per week. Exhibit 69 ¶ 46. Although she was asked to identify medical records in which a
4 Miller-Fisher Syndrome is also referred to as Miller-Fisher Variant or Fisher syndrome
and is sometimes abbreviated as MFS (or GBS-MFS) or MFV (or GBS-MFV). Those
abbreviations are referring to the same subtype of GBS.
5 James J. Sejvar et al., Guillain-Barré syndrome and Fisher syndrome: Case definitions
and guidelines for collection, analysis, and presentation of immunization safety data, 29 Vaccine
599, 602 (2011); filed as Exhibit A, Tab 9.
5

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medical professional documented a complaint about double vision after August 2016, she did
not. See id.
Expert Commentary about August medical records. Both endocrinologists retained in the
litigation opined that in August 2016, Ms. Gibbons was in perimenopause. Exhibit A at 12-13;
Exhibit 52 at 5. This means that Ms. Gibbons was no longer producing sex steroids as much as
she had previously. See Exhibit A, Tab 8 (Rodriguez) at 3.6
According to Dr. Jamieson, these appointments demonstrate that Ms. Gibbons’s MFS did
not last longer than six months. Exhibit A at 11-12. The Secretary has adopted this position.
Resp’t’s Br. at 19-35. Ms. Gibbons argues otherwise. Pet’r’s Br. at 12-20.
C. Other Records in 2016
Ms. Gibbons saw a urologist, Michelle Koski, on August 29, 2016. She described her
history of urinary retention and frequency, including occasional accidents. Exhibit 1 at 655. An
exam showed evidence of urethral prolapse. Id. at 657. A urethral prolapse, also known as
urethrocele, is “prolapse of the urethral mucosa” and is “a diverticulum of the urethral walls
encroaching upon the vaginal canal.” Dorland’s at 1977. Dr. Koski prescribed estrogen.
In Dr. Koski’s medical record, Dr. Koski states that Ms. Gibbons denied fatigue. Exhibit
1 at 656. Ms. Gibbons’s response to questions about this notation is ambiguous. On the one
hand, Ms. Gibbons stated that the medical record was accurate to her knowledge. However, Ms.
Gibbons also did not recall being asked about fatigue and stated that she would not tell a
urogynecologist about fatigue. Exhibit 69 (affidavit) ¶ 47.
Ms. Gibbons emailed her neuro-ophthalmologist, Dr. Kubis, stating that she was having
blurry vision in her right eye. She asked if blurry vision could be related to GBS-MFV. He
stated that it “shouldn’t be,” and recommended that she see an optometrist. Exhibit 1 at 669.
Ms. Gibbons’s statement about this medical record. Ms. Gibbons stated that she has a
regular eye doctor at Redhawk Vision. Exhibit 69 ¶ 48. However, Ms. Gibbons did not submit
any records from Redhawk Vision. Thus, there is no documentary evidence about persistent
problems with blurry vision.
D. January 16-17, 2017
Ms. Gibbons emailed her neurologist, Dr. Hawkins on January 16, 2017. Exhibit 1 at
765. She stated she was having increased urinary retention, tingling in her gums and jaw, and
she was concerned she may be having a relapse of GBS. A nurse associated with Dr. Hawkins
spoke with Ms. Gibbons the next day. Ms. Gibbons clarified that her tingling sensation lasted
only half of a day and resolved, she had no vision problems, but she did report a recent increase
6 Maria Rodriguz & Donna Shoupe, Surgical Menopause, 44 Endocrinol Metab Clin N
Am 531, 534 (2015); filed as Exhibit A, Tab 8.
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in stress. Id. at 765-66. Dr. Hawkins recommended no further workup. Id. at 764. As discussed
below, this exchange of emails in January 2017 is one basis for Ms. Gibbons’s argument that her
MFS lasted more than six months. See Pet’r’s Br. at 14-15.
E. Detection of Pelvic Mass and Removal of Ovaries
A January 22, 2017 CT scan revealed that a large mass was displacing Ms. Gibbons’s
uterus and bladder. Exhibit 1 at 777-79. An operation was planned. 7 As part of the
preoperative evaluation, Ms. Gibbons reported “continued mild fatigue with no current
paresthesias or neurologic sequelae.” Id. at 819-20. Ms. Gibbons underwent an operation on
February 16, 2017. The mass was identified as a “large left ovarian cyst . . . that completely
filled the pelvis.” Exhibit 1 at 941; see also Exhibit 5 at 7. The surgeons removed both of Ms.
Gibbons’s ovaries and her left fallopian tube. An operation to remove one or both ovaries is
called an “oophorectomy.” Dorland’s at 1305.
The next day, Ms. Gibbons emailed her surgeon to ask about estrogen patches and
progesterone. The surgeon stated that she could start those medications right away. Later,
adjustments could be made to make “sure you do not have strong hot flashes.” Exhibit 1 at 843.
The Secretary summarized Ms. Gibbons’s initial pharmacy record with hormonal
medications:
Resp’t’s Br. at 9. Ms. Gibbons did not challenge this summary. See Pet’r’s Reply.
Ms. Gibbons saw her gynecologist, Dr. Meredith McMullen, on March 13, 2017. Exhibit
1 at 880-83. Ms. Gibbons reported that she was taking Climara as a form of HRT. Because this
medical record did not list progesterone, the Secretary infers that Ms. Gibbons was not taking
7 Dr. Frankfurter commented that from his review of the records, Ms. Gibbons’s doctors
did not advise her before the operation that she would probably require hormone replacement
therapy. Exhibit F at 2.
7

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progesterone. Resp’t’s Br. at 9. Ms. Gibbons did not report any symptoms of menopause and
Dr. McMullen recommended that Ms. Gibbons continue her HRT.
Ms. Gibbons’s statement about this medical record. Ms. Gibbons recognized that after
the operation, she could have been experiencing fatigue. She was limited in her activities.
Exhibit 69 ¶ 50.
Ms. Gibbons informed Dr. McMullen that she was menstruating on March 22, 2017 and
asked whether this was normal. Exhibit 1 at 897. Dr. McMullen stated that when starting HRT,
bleeding can occur. After the hormone levels stabilize, the bleeding will stop.
According to the Secretary’s calculations reflected in the chart above, Ms. Gibbons’s
prescription for Climara ran out by April 25, 2017 and the supply of progesterone ran out by
April 30, 2017. See Resp’t’s Br. at 10. Ms. Gibbons did not fill her Climara again until July 3,
2017, 69 days after her prescription would have lasted had she been taking it as prescribed. Ms.
Gibbons did not refill her progesterone until May 21, 2018, 386 days after her prescription would
have lasted had she also taken it as prescribed.
On May 4, 2017, Ms. Gibbons emailed Dr. Hawkins and reported heat intolerance,
stating that she “walked around at a street festival last week where it was 75 degrees and almost
passed out,” and she was “sure is related to my nerves” and her GBS-MFV. Exhibit 1 at 901-02.
Dr. Hawkins did not comment on whether this symptom was related to GBS-MFV, but he
explained that Ms. Gibbons should avoid environments with excess heat. Id. The Secretary
contends that “there is no evidence petitioner explained that she had recently undergone removal
of her ovaries and was recently prescribed HRT.” Resp’t’s Br. at 10.
Ms. Gibbons’s statement about this medical record. Ms. Gibbons agreed that she did not
tell Dr. Hawkins about her hormone replacement therapy. However, in Ms. Gibbons’s view, she
expected that Dr. Hawkins would know about the hormone replace therapy because it was
documented in her medical records. Exhibit 69 (affidavit) ¶ 51.
Ms. Gibbons also elaborated upon the notation of having a problem in the heat. She
stated that heat intolerance has a “gradual onset.” She feels shortness of breath, nausea, and a
sense that she needs to sit down before she falls down. In contrast, a hot flash brings about
sudden heat and sweating without lasting fatigue. Id. at ¶ 51.b.
On this date, Ms. Gibbons experienced dizziness in the context of almost passing out.
She was also fatigued. Exhibit 69 ¶ 51.
In June 2017, Ms. Gibbons traveled from her home in California to North Carolina to
visit her parents. Exhibit 69 (affidavit) ¶ 30.
The Secretary presented more information about Ms. Gibbons’s use of HRT:
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Resp’t’s Br. at 10.
On September 7, 2017, Ms. Gibbons sought care from a mental health provider for
anxiety and possible depression. Exhibit 8 at 4. She described low energy, sleep problems, and
a history of depression. Id. She described trouble staying asleep, “hormone ?” Id. When
reporting her current medications, she only noted Ativan, and when asked if she took any over
the counter medications, her response was “you name it . . .” Id. at 7.
On September 12, 2017, Ms. Gibbons saw Dr. Hawkins and reported trouble with sleep,
daytime fatigue, anxiety, intermittent tingling in her perioral region, and an increased need for
“screening breaks since GBS.” Exhibit 6 at 20-21. Dr. Hawkins completed an exam and
explained that there were “no objective neurological deficits,” prescribed a trial of nortriptyline
for paresthesia (likely referring to her intermittent perioral tingling), and he explained that a
“[c]oexisting mood disorder likely influences her symptoms.” Id. at 21. Nortriptyline is an anti-
depressive medication that is also used to relieve chronic, severe pain. Dorland’s at 1273.
Ms. Gibbons’s statement about this medical record. Ms. Gibbons stated that she had
begun experiencing tingling in her perioral region in May 2016. Exhibit 69 (affidavit) ¶ 52.c.
When she talked to Dr. Hawkins in September 2017, Ms. Gibbons was experiencing the tingling
several times per day with episodes ranging from a few minutes to a few hours. Id. at ¶ 52.a-b.
The tingling in her perioral region was prompting Ms. Gibbons to take breaks from using screens
because she was worried that she was having a relapse of GBS. Id. at ¶ 52.j.
For the report of “daytime fatigue,” Ms. Gibbons stated that she had “whole body fatigue
after basic daily activities, such as going to the grocery store.” Id. at ¶ 52.e. This fatigue started
in May 2016. Ms. Gibbons denied having leg cramps and/or toe cramps. Id. at ¶ 52.i. She also
did not recall having dizziness. Id. at ¶ 52.l.
In a brief submitted after Ms. Gibbons filed her affidavit, she argues that Dr. Hawkins’s
September 12, 2017 medical record shows that she the residual effects of her MFV lasted more
than six months. More specifically, she argues that the notations about anxiety and depression
meet her burden. Pet’r’s Suppl. Br. The Secretary contends that this evidence is not sufficient.
Resp’t’s Suppl. Br.
During a return visit to her therapist on October 4, 2017, Ms. Gibbons again reported
concerns with fatigue and sleep issues. Exhibit 8 at 10. She reported a recent prescription for
nortriptyline, but she did not fill that prescription. Id. Her only reported medications were
melatonin and Ativan. Id. Ms. Gibbons averred that she did not list her HRT because these
medications were irrelevant to an appointment for mental health concerns. See Exhibit 56 at 2;
see also Pet’r’s Br. at 11.
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Ms. Gibbons’s statement about this medical record. Ms. Gibbons stated that the fatigue
was preventing her from doing “many activities with [her] daughter and [her] family.” Exhibit
69 (affidavit) ¶ 53.a. She was taking breaks during the day.
Ms. Gibbons also stated that for hormone replace therapy, she was using “Climara
estrogen patches, Pometrium progesterone, and Estrace vaginal cream." Id. at ¶ 53.b.
On October 16, 2017, Ms. Gibbons was seen for a weight management program, and she
reported that she exercised three days a week at a moderate or strenuous level. Exhibit 6 at 41.
Although Ms. Gibbons had recorded information about her exercises in a notebook, she no
longer possesses it. Exhibit 69 (affidavit) ¶ 54.d.
Her next HRT medication refills occurred as follows:
Resp’t’s Br. at 11.
F. Records from 2018
On February 24, 2018, Ms. Gibbons called Dr. McMullen to discuss hormone concerns.
Exhibit 9 at 110. She had been lifting weights for four months, and her body had not changed.
Id.
On May 21, 2018, Ms. Gibbons saw a provider associated with her PCP for unrelated
concerns. Exhibit 6 at 100. However, medications were discussed, and Ms. Gibbons stated that
she uses Climara once a week, but that she ran out and is getting more. Id. at 101. She only uses
Estrace as needed, and the record states that she was not taking progesterone. Id. at 102. She
explained that she was currently using a cream (although she did not explain what cream she was
using), and she was considering restarting progesterone. Id. When asked about this cream, Ms.
Gibbons stated that she was using progesterone cream as that form was better for her than
progesterone pills. Exhibit 69 (affidavit) ¶ 55.a.
HRT prescriptions were filled as follows:
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Resp’t’s Br. at 12.
On July 19, 2018, Ms. Gibbons visited her gynecologist, Dr. McMullen. Exhibit 6 at
114-17. Dr. McMullen documented that the patient was using estradiol patches and oral
micronized progesterone. Id. at 116. Ms. Gibbons complained of low libido and requested
testosterone. Id. at 115. There were no other gynecological complaints. Id. There was no
mention of hot flashes. Medications were documented with estradiol patch 0.05 mg/24h, applied
once weekly, micronized progesterone 200 mg/d and estradiol vaginal cream. Id. at 116. On
exam, her vagina was documented as normal appearing, suggesting an estrogen effect in the
vagina. Id. Dr. McMullen documented that they reviewed hormone replacement therapy (HRT)
in detail. Id. at 117. Ms. Gibbons wanted to switch to oral meds. Id. Her other HRT
medications, including estrogen patch, oral micronized progesterone and vaginal estrogen cream
were continued in that clinic documentation. Id.
Resp’t’s Br. at 12.
In January 2019, the following HRT medications were filled:
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Resp’t’s Br. at 13.
On March 25, 2019, Ms. Gibbons saw Cynthia Sorrell, M.D., for complaints of bilateral
cramping in her legs and toes that began a few days earlier and reoccur upon exertion. Exhibit
47 at 20. She was working out on an elliptical for 20 minutes a day, and during the last few days
she experienced cramping in the backs of her legs and toes. Id. She explained that she
experienced muscle cramping and an electrolyte disturbance when she was diagnosed with GBS.
Id. at 20. Her medications were discussed, and Ms. Gibbons explained that she stopped taking
oral prometrium due to her belief that it caused irregular bleeding, but she was using a Climara
patch. Exhibit 47 at 20. The assessment was abnormal vaginal bleeding, and bilateral leg
cramping. Id. at 21. Labs were ordered to check Ms. Gibbons’s electrolytes and she was urged
to talk with her gynecologist about changes to her HRT. Id.
Ms. Gibbons’s statement about this medical record. Ms. Gibbons stated that these leg
and toe cramps “started intermittently in 2017.” Exhibit 69 (affidavit) ¶ 56.b. She rated them as
7 or 8 in severity with 10 being a maximum. She also stated that one month after this report, she
“probably” still had leg and toe cramps. However, she does not remember any specific incidents.
Id. at ¶ 56.e.
In this litigation, Ms. Gibbons also connects this March 25, 2019 leg cramping to her
earlier neurologic disorder. Exhibit 48 (aff., signed Jan. 26, 2021) ¶ 6. The parties dispute
whether this leg cramping was a sequelae to the MFS. Compare Pet’r’s Br. at 13-14 with
Resp’t’s Br. at 32-34.
Also on March 25, 2019, she emailed Dr. Hawkins and reported issues with a headache,
cramping, and nausea, and feeling dehydrated. Exhibit 47 at 31. She also stated that when she
had GBS-MFV, she “had trouble with [her] sodium potassium balance” and that “this feels like
the same thing.” Id. at 31. Dr. Hawkins stated that she can try taking over-the-counter
magnesium, and if that does not work, she could take muscle relaxers. Id.
Ms. Gibbons’s statement about this medical record. Ms. Gibbons stated she does not
recall whether she was experiencing tingling in her perioral region, fatigue, or dizziness. Exhibit
69 (affidavit) ¶ 58.
On March 26, 2019, Ms. Gibbons emailed Dr. Sorrell and expressed concern that her labs
showed low electrolytes, and Ms. Gibbons was told that while she had a borderline low chlorine,
she should not be concerned unless she is experiencing active diarrhea, and her results were
otherwise normal. Exhibit 47 at 54. Her PCP reviewed the same labs and agreed that they were
normal and suggested that Ms. Gibbons take a potassium tablet for one week to help with her
cramping. Id. at 58.
On March 28, 2019, Ms. Gibbons saw Dr. Hawkins for leg cramping that was waking her
at night. Exhibit 47 at 66. He also noted that she does not drink much water and that her
electrolyte panel was normal. Id. Dr. Hawkins stated that a history of GBS may pre-dispose a
person to cramping, and he recommended increased hydration and magnesium supplements. Id.
at 67.
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The Secretary recounts the next steps for HRT:
Resp’t’s Br. at 14.
On April 30, 2019, Ms. Gibbons saw Dr. McMullen, who noted that Ms. Gibbons was
previously prescribed both progesterone and Climara, and that “she does not consistently use the
progesterone,” and “[s]ometimes she does not use the estrogen consistently either,” and she
“occasionally uses over-the-counter progesterone lotion.” Exhibit 47 at 77. Dr. McMullen noted
that Ms. Gibbons was not taking any medications at the time of this appointment. Id. at 81. Dr.
McMullen explained that Ms. Gibbons should take HRT as prescribed, including simultaneous
use of progesterone and Climara. Id. at 78. She changed Ms. Gibbons’s progesterone to
Prometrium 100mg, and recommend she also continue the Climara patch. Id. She cautioned Ms.
Gibbons that if she did not take her medication as directed, she could experience spotting. Id.
In September 2019, Ms. Gibbons returned to working as an acupuncturist on a part-time
basis. Exhibit 69 (affidavit) ¶ 23. She asserted that various health problems did not prevent her
from working more. Id. at ¶ 23.f.
G. Records from 2020
The Secretary recounts Ms. Gibbons’s HRT prescriptions:
Resp’t’s Br. at 15.
On August 7, 2020, over a year after she last saw Dr. McMullen, Ms. Gibbons emailed
Dr. Hawkins and stated that she was having more severe foot and leg cramps, and she was still
taking magnesium and drinking mineral water. Exhibit 57 at 28. She asked what other
prescription drugs were recommended and she asked for a mental health counselor in Escondido.
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Id. Baclofen was recommended. Id. Baclofen is a medication to relax muscles. Dorland’s at
188.
Ms. Gibbons noted that this medical record is a second time that a medical record
documents a complaint about leg cramps with the first instance being a March 25, 2019 instance.
Exhibit 69 (affidavit) ¶ 56.f.
The Secretary presents information about Ms. Gibbons’s HRT:
Resp’t’s Br. at 15.
Ms. Gibbons saw or spoke to her PCP twice more in 2020 and reported no relevant
issues. Exhibit 57 at 38, 44.
The Secretary presents one more chart related to Ms. Gibbons’s HRT:
Resp’t’s Br. at 16.
In March 2021, Ms. Gibbons emailed Dr. Hawkins about the COVID vaccines and saw
an allergist about the same concerns. Ms. Gibbons did not report any GBS-MFV complaints. In
August 2021, Ms. Gibbons asked her PCP for a letter supporting her need to cancel a gym
membership. Exhibit 57 at 137.
In January 2022, Ms. Gibbons sought care for an unrelated issue, and in July 2022, Dr.
McMullen’s records note that Ms. Gibbons’s attorneys requested to set up a call to discuss a
vaccine injury claim. Exhibit 57 at 209-10.
These are the most recent medical records addressed by the parties.
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II. Procedural History
Represented by Attorney Richard Gage, Ms. Gibbons alleged that the Tdap vaccine
caused her to suffer the Miller Fisher variant of Guillain-Barré syndrome. Pet., filed Apr. 11,
2018. She further alleged that her condition lasted more than six months. Id. ¶ 7. Over the next
year or so, Ms. Gibbons submitted evidence, such as medical records and an affidavit. The
Secretary advised the record appeared complete. Resp’t’s Status Rep., filed May 28, 2019.
The Secretary reviewed the evidence and recommended against an award of
compensation. Resp’t’s Rep., filed pursuant to Vaccine Rule 4 on July 12, 2019. The Secretary
interposed several objections. First, the Secretary questioned whether the Miller Fisher variant
was an appropriate diagnosis. Second, the Secretary disputed whether Ms. Gibbons’s condition
lasted longer than six months. Third, the Secretary maintained that Ms. Gibbons failed to present
evidence that the Tdap vaccine caused her (assumed) Miller Fisher variant. Id. at 9-10.
Because the parties anticipated obtaining reports from experts, a set of instructions was
proposed. After the parties did not interpose any objections, the instructions became final.
Orders, issued Oct. 29, 2019 and Nov. 22, 2019.
Ms. Gibbons supported her claim with a report from Dr. Steinman. Exhibit 10. Dr.
Steinman asserted that the Miller Fisher variant is an appropriate diagnosis. As to how the Tdap
vaccine can cause the MFV, Dr. Steinman proposed molecular mimicry. Dr. Steinman also
maintained that Ms. Gibbons’s disease lasted more than six months. With respect to severity,
Dr. Steinman’s report consists of one paragraph, largely quoting a medical record from January
2017 about tingling in her jaw. Id. at 36, citing Exhibit 1 at 764-65.
The Secretary responded with reports from experts in two fields. First, Dr. Jamieson
agreed that the MFV was an appropriate diagnosis. Exhibit A at 12. However, in other respects,
Dr. Jamieson disagreed with Dr. Steinman’s opinion. She maintained that Ms. Gibbons’s
“symptoms and signs of MFS resolved completely towards the end of August 2016,
approximately 3 months after their onset." Exhibit A at 17. In this context, she disputed how
Dr. Steinman interpreted the jaw tingling from January 2017. Id. at 11-12. Dr. Jamieson also
contested the assertion that the Tdap vaccine can cause the MFV. Id. at 17-18.
The Secretary’s second expert is Dr. Frankfurter. The crux of his opinion is to provide an
alternative explanation for some of Ms. Gibbons’s complaints. Dr. Frankfurter wrote:
Based upon my review of the materials provided, it is my opinion
that petitioner had a long standing history of urge urinary
incontinence due to extrinsic compression of bladder outflow due
to an ovarian mass. Subsequent findings of bilateral ovarian cysts
and consequent bilateral slapingo-opherctomy [sic]8 lead to a
8 Dr. Frankfurter probably intend to write: “salingo-oophorectomy.” The prefix “salingo”
refers to a tube, including a uterine tube. Dorland’s at 1638.
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surgical menopause. The spectrum of symptoms reported by
petitioner, heat intolerance, fatigue, and memory issues, and the
time course of their manifestation indicate that they most likely
arise from her menopausal experience.
Exhibit C at 13.
In the ensuing status conference, Mr. Gage stated that he had not decided whether to
retain a reproductive endocrinologist. Instead, Mr. Gage and Ms. Gibbons might propose an
informal way to resolve the case. See Order, issued Sep. 29, 2020.
A settlement proposal was not made promptly. Instead, Ms. Gibbons averred that she
suffers from leg cramps. Exhibit 48 (affidavit, signed Jan. 26, 2021). With that affidavit, she
added a second report from Dr. Steinman, who opined that Ms. Gibbons’s Miller Fisher
symptoms lasted more than six months because she had fatigue, leg cramps, and jaw tingling.
Exhibit 49.
In the next status conference, the parties disputed the value of this recently filed evidence.
Mr. Gage asserted that settlement should be more viable now that Dr. Steinman addressed
severity. To him, an endocrinologist would be relevant to only damages. However, the
Secretary, speaking through Attorney Debra Filteau-Begley, disagreed. In the Secretary’s view,
Dr. Frankfurter, the endocrinologist, addressed both the fatigue and leg cramps as manifestations
of menopause. The parties requested a tentative finding.
A Tentative Finding about six-month severity determined that “Dr. Steinman’s opinion is
neither persuasive nor credible.” Tentative Finding, issued Mar. 22, 2021, at 2. In short, Dr.
Steinman overlooked important details and failed to engage with the opinions from Dr. Jamieson
and Dr. Frankfurter. The Tentative Finding did not resolve the case but did advise that
continuing the case beyond this point might lack reasonable basis. Id. at 3-4.
Despite the warning, Ms. Gibbons decided to press onward. Pet’r’s Status Rep., filed
Apr. 21, 2021. Ms. Gibbons could retain an endocrinologist and was instructed to have the
endocrinologist address whether Ms. Gibbons took estrogen as her doctors prescribed. Order,
issued May 5, 2021.
The first report from Dr. Friday was filed on October 16, 2021. Exhibit 52. Dr. Friday
concluded that: “There is no evidence Ms. Gibbons was non-compliant with hormone
replacement therapy.” Id. at 8. Dr. Friday also stated that “her symptoms of fatigue cannot be
solely attributed to estrogen deficiency following bilateral oophorectomy.” Id. (Again, a
“bilateral oophorectomy” means both ovaries have been removed. Dorland’s at 1305.)
The Secretary responded with reports from both his experts. Dr. Jamieson stated that
neither fatigue, nor leg cramps, nor transient symptoms from January 2017 are manifestations of
Miller Fisher syndrome. Exhibit E at 6-7. Dr. Frankfurter generally opined that Ms. Gibbons’s
symptoms after her bilateral oophorectomy were more likely than not related to her menopause.
Exhibit F at 2-4. He also discussed Ms. Gibbons’s (lack of) hormone replace therapy. Id. at 4-5.
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In Dr. Friday’s next report, she continued to dispute the significance of Ms. Gibbons’s
menopause with Dr. Frankfurter. Exhibit 54. Dr. Friday recommended seeking more
information from the doctors who were treating Ms. Gibbons.
Thus, in the next status conference, the parties explored whether and how they might
obtain information from a treating doctor. Order, issued Aug. 10, 2022. But, Ms. Gibbons
relayed that her treating doctor was not interested in testifying. Pet’r’s Status Rep., filed Sep. 9,
2022. The parties, thus, determined that the expert report phase had concluded. The parties were
directed to file briefs, addressing severity as well as the Althen prongs. Order, issued Nov. 4,
2022.
Ms. Gibbons submitted updated medical records. Exhibit 57. She also presented another
affidavit. Exhibit 56 (signed Nov. 10, 2022).
As permitted in the November 4, 2022 order, Ms. Gibbons submitted another report from
Dr. Steinman about severity. Exhibit 63. Ms. Gibbons also argued that she was entitled to
compensation. The portion regarding severity runs approximately eight double-spaced pages.
Pet’s Br., filed Feb. 2, 2023, at 12-20. Ms. Gibbons primarily argues that the evidence
supporting her burden to meet the severity requirement include tingling, fatigue, eye strain,
muscle cramps in her legs, and the worsening of her symptoms in external heat. Id. at 14. These
are discussed in greater detail below.
The Secretary submitted his set of pre-adjudication materials on May 11, 2023. This set
included a brief and an updated curriculum vitae for Dr. Jamieson. The Secretary’s argument
against severity spans about 16 double-spaced pages. Resp’t’s Br., filed May 11, 2023, at 19-35.
Ms. Gibbons defended her position. Pet’r’s Reply, filed June 12, 2023 (essentially four pages of
which nearly all were devoted to severity).
In her primary brief, Ms. Gibbons seemed to be arguing that (a) she was experiencing
various residual symptoms during a relevant time but (b) she declined to tell medical
professionals about the symptoms. See Pet’r’s Br. at 15. Thus, the undersigned directed her to
answer a lengthy series of questions about her health and the medical records. Order, issued
June 6, 2024. It appeared that asking questions in writing might be advantageous because she
could consult material such as paper documents and electronic documents.
Ms. Gibbons submitted her statement as Exhibit 69 on September 23, 2024. She did a
good, but not perfect, job at answering questions. She disclosed that she had visited
acupuncturists.
Although another legal brief had not been requested, Ms. Gibbons again argued that her
case meets the severity requirement. Pet’r’s Suppl. Br., filed Oct. 18, 2024. Over the course of
approximately two pages, she primarily discussed fatigue and anxiety. She did not discuss the
information communicated through her February 23, 2024 affidavit, which is filed as Exhibit 69.
The Secretary requested that Ms. Gibbons present documents around her employment,
such as W-2’s. Resp’t’s Status Rep., filed Oct. 23, 2024. In an October 30, 2024 status
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conference, the Secretary explained that compared to the MFS, the surgery for her ovarian tumor
might have more greatly contributed to a loss of earnings.
Ms. Gibbons attempted to gather records from acupuncturists. Some entities reported
that they had no records. Exhibits 70-72. Other records were submitted as Exhibits 73-75.
Updated medical records were filed as Exhibit 76 and tax returns from 2015 to 2020 were filed
as Exhibit 77.
Ms. Gibbons communicated a settlement demand. Pet’r’s Status Rep., filed Feb. 21,
2025. The Secretary declined to participate in alternative dispute resolution. Resp’t’s Status
Rep., filed June 24, 2025. As settlement was not likely, the case returned to the litigation path.
The Secretary responded to Ms. Gibbons’s October 18, 2024 memorandum on severity
with his own brief devoted to this topic. The Secretary again maintained that the evidence did
not support a finding that Ms. Gibbons satisfied the six-month severity requirement. Resp’t’s
Suppl. Br., filed Aug. 8, 2025.
Ms. Gibbons defended her position that symptoms associated with her Miller-Fisher
syndrome lasted more than six months. Pet’r’s Suppl. Reply, filed Sep. 19, 2025. With that
submission, the case is ready for adjudication.
III. Standards for Adjudication
A petitioner is required to establish her case by a preponderance of the evidence. 42
U.S.C. § 300aa–13(1)(a). The preponderance of the evidence standard requires a “trier of fact to
believe that the existence of a fact is more probable than its nonexistence before [he] may find in
favor of the party who has the burden to persuade the judge of the fact's existence.” Moberly v.
Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d
867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is important
because a special master should not impose an evidentiary burden that is too high. Andreu v.
Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed. Cir. 2009) (reversing special
master's decision that petitioners were not entitled to compensation); see also Lampe v. Sec’y of
Health & Hum. Servs., 219 F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum.
Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge's contention that the
special master confused preponderance of the evidence with medical certainty).
In determining whether the evidence weighs in a petitioner’s finding, special masters are
required to consider the record as a whole. 42 U.S.C. § 300aa–13(a)(1). When special masters
consider all the evidence, they have discretion in how to weigh the evidence. Whitecotton v.
Sec’y of Health & Hum. Servs., 81 F.3d 1099, 1108 (Fed. Cir. 1996).
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IV. Element of Petitioner’s Claim: Severity
To receive compensation in the Vaccine Program, a petitioner must demonstrate with
preponderant evidence five elements found in paragraphs (A) through (E) of 42 U.S.C. § 300aa–
11(c)(1). Most frequently, the disputed element is the causation element, which is found in
paragraph (C). In this case, too, the parties dispute causation. However, the more critical
element is the severity element, which is found in paragraph (D).
A petitioner may meet this element by establishing that her injury lasted more than six
months.9 The failure to establish six months of injury results in a denial of compensation. See
Stavridis v. Sec’y of Health & Hum. Servs., No. 07–261V, 2009 WL 3837479, at *4 (Fed. Cl.
Spec. Mstr. Oct. 29, 2009); Song v. Sec’y of Health & Hum. Servs., No. 92-279V, 1993 WL
534746 (Fed. Cl. Spec. Mstr. Dec. 15, 1993), mot. for rev. denied, 31 Fed. Cl. 61 (1994), aff’d,
41 F.3d 1520 (Fed. Cir. 1994) (table).
In looking to determine whether a problem lasted more than six months, special masters
have considered whether there is a gap between when the allegedly vaccine-induced illness
concluded and when the alleged symptom of that disease was first manifest. See Moyler v.
Sec’y of Health & Hum. Servs., No. 21-1720, 2025 WL 3167857, at *6-7 (Fed. Cl. Sep. 3, 2025)
(ruling that the special master was not arbitrary in finding that petitioner’s brachial neuritis did
not last six months due to a gap in treatment), appeal docketed, No. 2026-1115 (Fed. Cir. Oct.
30, 2025); Wyatt v. Sec’y of Health & Hum. Servs., 144 Fed. Cl. 531, 539-40 (2019) (ruling that
the special master reasonably found that petitioner’s lack of complaint for many years meant that
petitioner’s pain was not the residual effect of petitioner’s alleged vaccine-related injury).
V. Analysis
Ms. Gibbons advances several problems that she alleges that the Miller-Fisher syndrome
caused her to experience more than six months after onset. These include the following:
tingling, fatigue, leg cramps, eye strain, heat sensitivity, and anxiety/depression. The Secretary
disputes each allegation. An analysis of each point follows.
A. Tingling
When first called upon to present an opinion that Ms. Gibbons meets the severity
requirement, Dr. Steinman relied exclusively upon the January 2017 email exchange between
Ms. Gibbons and the office of her neurologist. Exhibit 10 at 36 (citing Exhibit 1 at 764-65). Dr.
9 The Vaccine Act also allows a petitioner to receive compensation if either the vaccinee
died or the vaccinee underwent a surgical procedure. However, Ms. Gibbons did not die and has
not undergone a surgery for her reaction to the vaccine.
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Jamieson responded to Dr. Steinman’s contention, arguing against the persistence of MFS
symptoms. Exhibit A at 11-12.
Consistent with Dr. Steinman’s opinion, Ms. Gibbons argues that tingling that she
experienced in January 2017 and later in September 2017 was because her cranial nerves had not
yet completely healed. Pet’r’s Br. at 15. The Secretary challenged this position. Resp’t’s Br. at
31-32.
Dr. Steinman’s opinion appears to be based upon a selective and incomplete review of
the medical records. First, as Dr. Jamieson points out, in 2017, when Ms. Gibbons reported
tingling in her jaw, she also reported stress. Exhibit A at 12; see also Exhibit 1 at 766. Ms.
Gibson also reported tingling in the context of stress in 2014. Exhibit 1 at 26-27. Dr. Steinman
fails to account for this earlier episode.
Second, Dr. Steinman also overlooks the remainder of the trouble reported in January
2017. Ms. Gibson told the neurologist’s nurse that the “tingling sensation only lasted half day.”
Exhibit 1 at 764. According to Dr. Jamieson, the “report of hours of transient sensory
complaints absolutely does not indicate a duration of MFS symptoms beyond 3 months.”
Exhibit A at 12.
Although Dr. Steinman opined that the “most likely cause of the 2017 symptom is that
the cranial nerve that was attacked during the acute phase of [Ms. Gibson’s] GBS had not yet
fully healed,” Exhibit 49 at 2, this opinion lacks persuasiveness. Dr. Steinman has not
persuasively explained why there appears to be only two episodes of tingling after August 2016,
separated by approximately eight months. See id. If the nerve were not healed, then it seems
reasonable to expect that the damaged nerve would cause problems frequently and more
consistently. Moreover, Dr. Steinman’s opinion that Ms. Gibsons’s nerves had not completely
healed is inconsistent with her report to Dr. Hawkins on June 16, 2016 that she was not having
any numbness and tingling. Exhibit 1 at 507.
For these reasons, the report of tingling does not satisfy Ms. Gibbons’s burden to show
her Miller Fisher syndrome lasted more than six months.
B. Fatigue
Ms. Gibbons points to fatigue as a manifestation of her GBS. Pet’r’s Br. at 13-14. She
cites three articles about fatigue and GBS. These articles constitute a basis for finding that GBS
can have fatigue as a sequela.
She also maintains that she suffered from fatigue. Of the five sources Ms. Gibbons listed
to support her assertion that she had fatigue, three of them are her affidavits. See Pet’r’s Br. at
14, citing Exhibit 3 (damages affidavit, signed July 13, 2018); Exhibit 48 (affidavit, dated
January 26, 2021); Exhibit 56 (affidavit, dated November 10, 2022). A preponderance of
evidence supports a finding that Ms. Gibbons, periodically, suffered from fatigue. In today’s
world, it would be relatively difficult to find adults who are not fatigued from time-to-time.
Virtually everyone’s life is busy. See Exhibit 52 (report of Dr. Friday) at 8 (“fatigue can be
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attributed to a number of conditions, including lingering effects of MFGBS”); see also Meylor v.
Sec’y of Health & Hum. Servs., No. 10-770V, 2016 WL 3165774, at *12 (Fed. Cl. Spec. Mstr.
May 16, 2016) (citing testimony of petitioner’s expert that symptoms typical for menopause
include fatigue).
Even with a finding that (a) GBS can cause fatigue, and (b) Ms. Gibbons experienced
some fatigue, it is not automatically the case that GBS caused Ms. Gibbons’s fatigue. To make
this finding automatically would conflict with the well-established principle that a temporal
sequence in which one event preceded another event does not mean that earlier event caused the
latter event. See, e.g., Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1347-48 (Fed.
Cir. 2010).
In this regard, a critical piece of evidence is Ms. Gibbons’s report to Dr. Koski on August
29, 2016 that she was not having fatigue. Exhibit 1 at 656. Ms. Gibbons stated that she was not
having fatigue just a few weeks after her neuro-ophthalmologist determined that her eye
weakness and ptosis were resolved. Exhibit 1 at 647 (Aug. 9, 2016). If the GBS caused Ms.
Gibbons to experience fatigue, then the fatigue would appear in medical records created close in
time to when Ms. Gibbons was being seen by doctors for the GBS.
Other than the three affidavits, Ms. Gibbons brought forward two medical records in
which fatigue was mentioned. Pet’r’s Br. at 14. Both medical records were created months after
Dr. Koski’s record. The earlier of these two records was created on February 9, 2017, when Ms.
Gibbons was facing a surgery to remove at least one ovary due to a mass in her abdomen.
Exhibit 1 at 818-19 (noting mild fatigue). The other medical record that Ms. Gibbons cited was
Dr. Hawkins’s September 12, 2017 record. But, in addition to reporting daytime fatigue, Ms.
Gibbons reported trouble with sleep as well as anxiety. Exhibit 6 at 20-21.10
On balance, the weight of the evidence does not support finding that fatigue was a
residual to Ms. Gibbons’s GBS because she has not provided preponderant evidence to meet her
burden, such as contemporaneously created medical records that relate her fatigue to her GBS.
Her primary evidence consists of her affidavits describing her fatigue and relating it to her GBS.
Thus, this symptom does not help her fulfill the severity requirement.
C. Leg Cramps
Ms. Gibbons proposes that she suffered leg cramps as a sequela to GBS. Pet’r’s Br. at
13. Through Dr. Steinman, she presented an article finding that roughly half the patients with
GBS suffer residual leg cramps. Exhibit 51 (Bernsen).11 She also asserts that she complained
about legs cramps in 2019 and 2020. She emphasizes a report to Dr. Hawkins on March 28,
10 Ms. Gibbons argues that the anxiety was due to GBS. This point is addressed below.
11 R.A.J.A.M. Bernsen et al., Long-term sensory deficit after Guillain-Barré syndrome,
248 J Neurol 483 (2001); filed as Exhibit 51.
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2019. Pet’r’s Br. at 11-13. In this report, Dr. Hawkins wrote that Ms. Gibbons’s prior “Guillain-
Barré history may predispose her to be more likely to getting cramps.” Exhibit 47 at 67.
The Secretary disagrees. According to an article Dr. Jamieson cited, leg cramps are
common in the general population, not just people with GBS. Exhibit E, Tab 2 (Hallegraeff).12
Moreover, the study on which Dr. Steinman relied found that people with leg cramps also had
sensory deficits detectable on examination. Exhibit 51 (Bernsen) at 484.
The Secretary pointed out that Ms. Gibbons differs from people discussed in the Bernsen
article. While those people had GBS and leg cramps, they also had sensory deficits. But, Ms.
Gibbons was evaluated for sensory deficits and found not to have any. Exhibit 1 at 306-07 (May
22, 2016); at 507-08 (June 15, 2016); at 620-21 (Aug. 2, 2016); Exhibit 6 at 20-21 (Sep. 12,
2017). Ms. Gibbons did not persuasively counter this argument.
Another problem with Ms. Gibbons’s argument is the latency. The earliest time that leg
cramps appear in medical records is in 2019. See Pet’r’s Br. at 13. Ms. Gibbons experienced the
worst of the GBS in the summer of 2016. Thus, approximately three years passed between the
onset of the GBS and the reports of leg cramping. Neither Dr. Steinman nor Ms. Gibbons has
persuasively explained how this sequence suggests that the GBS caused the leg cramping.
The lack of explanation also diminishes, to a degree, the report from Dr. Hawkins. To
repeat, Dr. Hawkins stated that a history of GBS “may predispose” Ms. Gibbons to getting
cramps. Exhibit 47 at 67. As a statement from a doctor treating Ms. Gibbons, Dr. Hawkins’s
statement merits careful consideration but is not dispositive. Capizzano v. Sec’y of Health &
Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006); Snyder v. Sec’y of Health & Hum. Servs.,
88 Fed. Cl. 706, 745 n.67 (2009). On its face, the phrasing of Dr. Hawkins’s statement
introduces questions about its persuasiveness. See Paterek v. Sec’y of Health & Hum. Servs.,
527 F. App’x 875, 883 (Fed. Cir. 2013) (testimony from a treating doctor that causation was “not
impossible” fails to provide support for causation); Nieves v. Sec’y of Health & Hum. Servs.,
167 Fed. Cl. 422, 429 (2023) (ruling that special master was not arbitrary and capricious in not
crediting statement from treater that vaccine-causation was "possible"); Henkel v. Sec’y of
Health & Hum. Servs., 165 Fed. Cl. 153, 159 (2023) (ruling that special master reasonably gave
little weight to a treating doctor’s statement that the vaccinee’s condition “may or may not have
been related to a flu vaccine”), aff’d, 2024 WL 3873569 (Fed. Cir. Aug. 20, 2024); Orloski v.
Sec’y of Health & Hum. Servs., 147 Fed. Cl. 713, 726 (2020) (ruling that special master was not
arbitrary in refraining from crediting report from treating doctor when, among other points, the
treater did not address timing), aff’d, 839 F. App’x 538 (Fed. Cir. 2021); Doe v. Sec’y of Health
& Hum. Servs., 19 Cl. Ct. 439, 452 (1990) (“a vague statement that something may be possible
cannot serve as the linchpin for meeting a burden of proof by the preponderance of the
evidence”); Stricker v. Sec’y of Health & Hum. Servs., No. 18-56V, 2024 WL 263189, at *24
(Fed. Cl. Spec. Mstr. Jan. 2, 2024) (finding that a treating doctor’s statement that vaccine-
12 Joannes Hallegraeff et al., Criteria in diagnosing nocturnal leg cramps: a systematic
review, 18 BMC Family Practice 1 (2017); filed as Exhibit E, Tab 2.
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causation is “very possible” is not a statement supporting causation), mot. for rev. denied, 170
Fed. Cl. 701, 722 (2024) (reasoning that the special master’s finding that a treating doctor’s
statement that uses “very possible” to suggest vaccine causation does not by itself meet the
preponderant standard was not arbitrary).
This set of (non-binding) precedents reflect a common theme---a doctor’s statement that
something “may” happen reflects indeterminacy. In other words, an expression that something
“may” happen is similar to saying that something “may not” happen. Although in the Vaccine
Program, petitioners are not required to establish their cases with scientific certainty, petitioners
do bear a burden of proof to show that whatever they are proposing is more likely than not.
Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Here, the
ambiguousness in Dr. Hawkins’s statement, the long latency between when Ms. Gibbons
experienced GBS and when she reported leg cramps, the lack of explanation from Dr. Steinman
for why the latency was several years, and the frequency in which leg cramps afflict people
without GBS combine to make the leg cramps not likely to be a sequela to GBS.
D. Eye Strain
Ms. Gibbons includes “eye strain” among her residual symptoms of GBS-MFV. Pet’r’s
Br. at 19. She points to a report of eye strain to Dr. Hawkins on September 12, 2017. Id. at 10,
citing Exhibit 6 at 20-21. Her affidavits also mention eye strain. Exhibits 48 and 56, cited in
Pet’r’s Br. at 12. She contends that menopause does not cause eye strain.
A problem with Ms. Gibbons’s arguments is that a gap interferes with her proposed
chronology. It is certainly correct that Ms. Gibbons experienced problems with her vision when
she was hospitalized for MFS. See, e.g., Exhibit 1 at 306 (May 22, 2016), id. at 307 (consult
with ophthalmologist on May 23, 2016). The question is how long did she experience these
problems because during the hospitalization, her vision issues improved. Exhibit 1 at 507 (June
15, 2016).
On August 2, 2016, she stated there was “Improvement in double vision, balance post
IVIG.” Exhibit 1 at 620. This report is consistent with an August 9, 2016 report to Dr. Kubis
that her “double vision slowly resolved near latter portion of July 2016.” Exhibit 1 at 640.13
A few months later, Ms. Gibbons was concerned about blurry vision in her right eye. She
wrote to Dr. Kubis wondering if it were related to her MFS-GBS. Dr. Kubis replied: it
“Shouldn’t be” and advised her to see an optometrist as soon as possible. Id. at 669 (Oct. 24,
2016). Ms. Gibbons did not promptly seek treatment with an optometrist. See Exhibit 69 ¶ 48.
Moreover, no records from Redhawk Vision were submitted.
In connection with Ms. Gibbons’s report of tingling in her jaw, Nurse Carmen Gutierrez
memorialized information from Ms. Gibbons that she had “No vision problem.” Exhibit 1 at 764
13 The information that Dr. Kubis gathered is especially important because Dr. Kubis
specializes in neuro-ophthalmology. Exhibit 1 at 307.
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(Jan. 17, 2017). This affirmative statement that Ms. Gibbons was not having vision problems
differentiates this case from situations in which relevant records are silent. See Kirby v. Sec’y of
Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021).
Thus, there is a period in which Ms. Gibbons did not report any problems with eye strain.
In August 2016, she reported improvement in double vision. In October 2016, a neuro-
ophthalmologist informed her that any blurry vision was unlikely to be due to her MFS-GBS. In
January 2017, Ms. Gibbons reported no vision problems. This period in which Ms. Gibbons did
not report any eye strain separates her later reports of eye strain. See Song v. Sec’y of Health &
Hum. Servs., 31 Fed. Cl. 61, 68 (1994) (ruling that an intervening normal neurologic evaluation
was a basis for the special master to find that subsequent speech delay was not related to the
problem a vaccination allegedly caused, a seizure), aff’d, 41 F.3d 1520 (Fed. Cir. 1994). With a
statement from Dr. Kubis that blurry vision arising in October 2016 was not likely to be due to
MFS-GBS, why should the development of eye strain about 11 months after the blurry vision be
related to the MFS?
The doctor to whom Ms. Gibbons reported her eye strain, Dr. Hawkins, did not connect
the MFS to the eye strain. Instead, Dr. Hawkins found “no objective neurologic deficits.”
Exhibit 6 at 21. He suspected various symptoms were due to Ms. Gibbons’s “coexisting mood
disorder.” Id.
Accordingly, the evidence does not support a finding that Ms. Gibbons’s eye strain was a
sequela to her MFS.
E. Heat Sensitivity
Ms. Gibbons argued that the Miller-Fisher variant caused her to be sensitive to
temperature (heat) and this sensitivity has lasted more than six months. Pet’r’s Br. at 12, 14-19.
Ms. Gibbons relies, in part, on the opinions from Dr. Steinman and Dr. Friday. Exhibit 52 at 8-9,
Exhibit 49 at 1-2. In contrast, relying upon the opinions from Dr. Frankfurter, the Secretary
contends that episodes of hot flashes “are a known symptom associated with estrogen
withdrawal, consistent with peri-menopause." Resp’t’s Br. at 26.
The parties agree that Ms. Gibbons first reported a symptom consistent with heat
intolerance in August 2016. See Pet’r’s Br. at 16; Resp’t’s Br. at 29. More specifically, on
August 2, 2016, Ms. Gibbons told her neurologist, Dr. Hawkings, that she “[f]eels her symptoms
worsen in heat.” Exhibit 1 at 620. On August 9, 2016, she saw Dr. Kubis and recounted that felt
“much better and near normal unless I get overheated and then I have to sit down.” Id. at 640.
August 2016 is significant for two reasons. First, August 2016 is less than six months
after the onset of the Miller-Fisher variant. Thus, even if these reports of heat sensitivity were
due to the Miller-Fisher variant, they would not, by themselves, establish that Ms. Gibbons meets
the six-month requirement. Second, in August 2016, Ms. Gibbons was likely in perimenopause.
Two doctors retained for their expertise on this topic agree about Ms. Gibbons’s being in
perimenopause. Dr. Friday wrote: Ms. Gibbons “was likely perimenopausal, even before her
bilateral oophorectomy, based [on] her age of 47 years as well as documentation of hot flashes in
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the [neurology] note by Dr. Koski." Exhibit 52 at 8. Dr. Frankfurter, in turn, wrote: “I agree
with Dr[.] Friday that Ms. Gibbons was likely experiencing hot flashes associated with
menopause in August 2016.” Exhibit F at 1-2. Thus, reliable evidence supports a finding that
Ms. Gibbons’s perimenopause (and not her Miller-Fisher variant) caused her heat intolerance
and hot flashes in August 2016. See also Exhibit C at 17-18 (Dr. Frankfurter explaining that
“‘hot flashes’ or ‘flushes’ are viewed as a classic menopausal finding”).
Ms. Gibbons transitioned from perimenopause to a sudden menopause when her ovaries
were removed in February 2017. Exhibit 1 at 856. The lack of ovaries means that Ms. Gibbons
was likely to experience symptoms of menopause. Exhibit C at 18; see also Exhibit C, Tab 2
(Bachmann) at S313.14 In this regard, Dr. Frankfurter appears to criticize the doctors caring for
Ms. Gibbons because they did not document that they advised Ms. Gibbons before her bilateral
oophorectomy that she could require hormone replacement therapy. Exhibit F at 2.
The next question is what was the effect, if any, of hormone replacement therapy? Based
upon Ms. Gibbons’s prescription records, the Secretary painstakingly established with
preponderant evidence that “petitioner’s records show that she rarely took HRT as prescribed,
she almost never took prescribed progesterone and there were frequently large gaps in time when
she was not taking Climara.” Resp’t’s Br. at 30. In this regard, Dr. Friday’s assertion that
“There is no documented evidence that Ms. Gibbons was non-compliant with hormone
replacement therapy,” Exhibit 54 at 4, is not based upon a thorough review of the pharmacy
records, which Dr. Friday stated she had reviewed. Dr. Friday’s failure to investigate Ms.
Gibbons’s (lack of) hormone replacement therapy reduces Dr. Friday’s credibility as an expert
witness.
According to information the Secretary presented, and which Ms. Gibbons did not rebut,
assuming that Ms. Gibbons took her medications as prescribed, Ms. Gibbons ran out of Climara
patches and progesterone at the end of April 2017. Resp’t’s Br. at 9. On May 4, 2017, Ms.
Gibbons informed Dr. Hawkins that she was “still having issues with intolerance to heat which I
am sure is related to my nerves and the MFGBS. I walked around at a street festival last week
where it was 75 degrees and almost passed out." Exhibit 1 at 902.
This May 4, 2017 medical record from Dr. Hawkins is a focus of the parties’ arguments
regarding severity as this event occurred more than six months after the onset of the Miller-
Fisher variant. See Pet’r’s Br. at 14, 16-17. It also appears to be the last time that Ms. Gibbons
complained about a heat problem.
Several reasons prevent a finding that this May 4, 2017 episode was a sequela to the June
2016 episode of Miller-Fisher syndrome. First, as noted with respect to leg cramps and eye
strain, there is a latency between the two events. (The problems with heat in August 2016 do not
really help Ms. Gibbons because Dr. Friday has recognized that the August 2016 problems were
14 Gloria A. Bachmann, Vasomotor flushes in menopausal women, 180 Am J Obstet
Gynecol S312, S313 (1999); filed as Exhibit C, Tab 2.
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due to perimenopause.) There is not persuasive evidence to explain why, if the Miller Fisher
syndrome were causing problems with heat, the problems would not become apparent until more
than 10 months later.
Second, Dr. Steinman’s opinion that heat intolerance is due to Miller Fisher syndrome is
not persuasive. To start, Dr. Steinman attempted to link heat intolerance to a peripheral
neuropathy in his fourth report on the topic. See Exhibit 63 at 3. Although it is certainly the
case that, theoretically, continued review and analysis could lead to insights not initially
appreciated, Dr. Steinman’s proposal of heat intolerance seems to be a belated afterthought. In
any event, Dr. Steinman reasoned that people with peripheral neuropathies can have
dysautonomia and dysautonomia can include problems with heat. Id. at 4; see also Pet’r’s Br. at
13 (discussing dysautonomia for two sentences). However, Ms. Gibbons has not presented any
persuasive evidence that she suffers from dysautonomia. Exhibit 69 ¶ 63 (failing to identify any
doctors who stated that she has dysautonomia).
Third, and the most important reason, is that evidence weighs in favor of finding that Ms.
Gibbons’s problem with heat is more likely than not due to her abrupt menopause. Menopause
can cause women to have problems with heat. Exhibit 63 (Dr. Steinman’s report) at 3-4; see also
Meylor, 2016 WL 3165774, at *10 (citing testimony of petitioner’s expert that “hot flashes and
night sweats [are] the hallmarks of the menopausal transition”) (internal quotation marks
omitted). As already noted, Dr. Friday has acknowledged that the August 2016 episodes of heat
intolerance were due to perimenopause. Thus, Dr. Friday attempts to differentiate what Ms.
Gibbons reported in May 2017 from what she reported in August 2016. See Exhibit 52 at 7, 9
(point 4); Exhibit 54 at 2. In doing so, Dr. Friday concedes that with respect to the May 2017
episode reported to Dr. Hawkins, “I can't eliminate the possibility of menopause related
symptoms.” Exhibit 54 at 2, Dr. Friday continues: “but this brief comment certainly does not
confirm a menopause causation." Id.
Dr. Friday mentions that Dr. Hawkins did not connect the near fainting at the street
festival to menopause. Exhibit 54 at 2. Dr. Friday’s observation is accurate. See Exhibit 1 at
902. But, the inference that seems to be requested is not preponderantly established. One
problem is that Dr. Hawkins also did not state that Ms. Gibbons’s heat intolerance was due to
GBS. Dr. Hawkins’s lack of attribution could be problematic because Dr. Hawkins had treated
Ms. Gibbons for her Miller-Fisher syndrome. See, e.g., Exhibit 1 at 509. The other side of this
coin is that Dr. Hawkins appears not to have been aware that Ms. Gibbons had her ovaries
removed about three months earlier. Exhibit 69 (affidavit) ¶ 51; see also Resp’t’s Br. at 30. This
lack of awareness could explain why Dr. Hawkins did not raise any hormonal explanations for
her problems.
In any event, because Dr. Hawkins is basically silent about any causes for Ms. Gibbons’s
heat problem, Ms. Gibbons must rely upon the opinions from her experts. (Dr. Steinman’s
opinion has been addressed above.) Dr. Friday accepts that “menopausal associated symptoms
of heat intolerance are possible.” Exhibit 54 at 2. However, Dr. Friday appears to require a
relatively high level of proof as she wrote menopausal associated symptoms of heat intolerance
“are certainly not the only explanation” and Dr. Kubis’s assessment “certainly does not confirm
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a menopause causation.” At a level of proof in which certainty is not required, Dr. Frankfurter’s
opinion that the May 2017 episode is from menopause is credited. See Exhibit F at 1.
The acceptance of the opinion from the Secretary’s retained expert leads to the fourth and
final reason for not finding that the May 2017 episode was from the Miller-Fisher syndrome.
Ms. Gibbons argues that her statement to Dr. Hawkins (the “intolerance to heat which I am sure
is related to my nerves and the MFGBS”) should be credited. Pet’r’s Br. at 14, citing Exhibit 56.
Admittedly, Ms. Gibbons stands in a different position from most petitioners in the Vaccine
Program in the sense that she worked on projects involving women’s health. See Exhibit 56 ¶ 5;
Exhibit 69 ¶ 10; see also Dobrydnev v. Sec’y of Health & Hum. Servs., 94 Fed. Cl. 134, 147
(2010), reversed on other grounds, 566 Fed. App'x 976 (Fed. Cir. 2014).
The accuracy of Ms. Gibbons’s causal conclusion can be disputed without necessarily
challenging the observation. See James-Cornelius v. Sec’y of Health & Hum. Servs., 984 F.3d
1374, 1380 (Fed. Cir. 2021). Drawing a causal connection (Ms. Gibbons’s Miller Fisher
syndrome caused her heat intolerance) would seem to require a medical degree. See 42 U.S.C.
§ 300aa–13(a). Ms. Gibbons does not possess this qualification. Although Ms. Gibbons may
have sincerely believed that her heat intolerance was neurologic, the neurologist who was
treating her, Dr. Hawkins, did not endorse that belief. Further, the neurologist whom Ms.
Gibbons retained in the litigation, Dr. Steinman, seemed to come up with the idea that the heat
intolerance was due to the Miller-Fisher variant as an afterthought.
For these reasons, Ms. Gibbons has not persuasively shown that the May 2017 episode of
heat intolerance was a sequela to her Miller-Fisher syndrome. Thus, heat intolerance does not
assist her in satisfying the severity requirement.
F. Anxiety / Depression
After Ms. Gibbons answered a lengthy series of questions (Exhibit 69, affidavit, filed
Sep. 23, 2024) she was permitted to file a supplemental brief. She proposed that she suffered
from anxiety and depression. Pet’r’s Suppl. Br.
The basis for Ms. Gibbons’s argument is as follows: on August 2, 2016, Ms. Gibbons
self-referred herself to see her neurologist, Dr. Hawkins, for “mild depressive symptoms.”
Exhibit 1 at 620-21. Dr. Hawkins directed Ms. Gibbons to follow up in three months. However,
it appears that Ms. Gibbons did not return around November 2016.
Rather, Ms. Gibbons returned to Dr. Hawkins on September 12, 2017. Exhibit 6 at 20.
Her current problems included “anxiety related symptoms.” Id. at 21.15 Dr. Hawkins recorded
15 Ms. Gibbons appears to misinterpret Dr. Hawkins’s September 12, 2017 medical
record. Although this medical record does list “Psych self referral for mild depressive
symptoms,” this information appears under a heading “LV [last visit] 8/2016.” Id. at 20. As
explained in the text, the medical record from August 2, 2016 does reflect a presentation for mild
depressive symptoms.
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that Ms. Gibbons has “been seen by psychologist recently which was helpful.” Id. Dr.
Hawkins’s assessment included: “Coexisting mood disorder likely influences her symptoms,
seeing psychologist.” Id.
The account that Ms. Gibbons had seen a psychologist was accurate. The records show
that on September 7, 2017, Ms. Gibbons had her first appointment with a psychologist named
Victoria Steese. Exhibit 8 at 9 (doctor’s signature). Ms. Gibbons informed Dr. Steese that she
had Guillain-Barré / Miller Fisher variant in May 2016 and her ovaries removed in March 2017.
Id. at 7. The history of present illness relates, in part, that Ms. Gibbons reports “high anxiety
depressive [symptoms] low energy sleep prob. [Client] reports a [history] of depression & recent
[diagnosis] of major illness & unknown prognosis causing anx, depressive [symptoms] to
return.” Id. at 4. Dr. Steese reached an initial diagnosis of moderate depression and unspecified
anxiety. Id. at 9. Dr. Steese planned to treat Ms. Gibbons by, among other things, teaching
coping skills.
Ms. Gibbons had a second (and apparently final) appointment with Dr. Steese on October
4, 2017. Dr. Steese memorialized that her client said she was “feeling better.” Exhibit 8 at 10.
Although Dr. Steese recommended that Ms. Gibbons return in 1-2 weeks, no other medical
records appear within Exhibit 8.
Various problems prevent the September-October 2017 reports of anxiety and depression
from being persuasively connected to the June 2016 episode of Miller-Fisher syndrome. A
preliminary issue is that whether purely psychologic harms satisfy the six-month severity issue
appears unsettled. See Valdez v. Sec’y of Health & Hum. Servs., No. 18-1550V, 2024 WL
3738449, at *31 (Fed. Cl. Spec. Mstr. July 8, 2024).
The second issue is that between the Miller-Fisher episode and the report of depression
and anxiety, Ms. Gibbons underwent a bilateral oophorectomy. Ms. Gibbons told Dr. Streese
about both the Miller Fisher variant and the removal of her ovaries in March 2017. The presence
of these two conditions makes the reference to a “recent [diagnosis] of a major illness”
ambiguous. Strictly in terms of timing, the operation for her ovarian cyst was more recent than
the Guillain-Barré syndrome.
The removal of Ms. Gibbons’s ovaries, in turn, leads to a third problem with Ms.
Gibbons’s argument that her reports of anxiety and depression in September and October 2017
were due to the June 2016 episode of Miller-Fisher syndrome. This third problem is that the
Secretary is proposing an alternative explanation for the anxiety and depression, Ms. Gibbons’s
failure to take hormone replacement therapy as prescribed. Resp’t’s Suppl. Resp., filed Aug. 8,
2025, at 7, citing Exhibit F (Dr. Frankfurter’s report) at 5. The argument that anxiety and
depression come from menopause is far from frivolous. See Meylor, 2016 WL 3165774, at *10
(citing testimony of petitioner’s experts that anxiety and depression can be symptoms of
premature ovarian insufficiency). For these reasons, Ms. Gibbons has not met her burden in
establishing that she has met the six-month severity requirement.
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G. Summary
As presented above, Ms. Gibbons presents a series of problems that she attempts to relate
to her Miller-Fisher syndrome. The series is drawn from her briefs, which unfortunately did not
always separate one type of problem from the next. The undersigned has attempted to decipher
Ms. Gibbons’s arguments as best as possible.
Overall, the relatively lengthy list of potential long-lasting sequela weakens Ms.
Gibbons’s arguments. The expansive list leaves an impression that Ms. Gibbons is grasping for
a straw to anchor her argument that she fulfills the statutory requirement for a severe illness. If it
were readily apparent, on a more likely than not basis, that one of the potential problems were a
sequela to the Miller-Fisher syndrome, then it seems that the other potential problems would not
have been advanced.
Regardless of how Ms. Gibbons argued her case, the undersigned has reviewed the entire
records, particularly her medical records, her affidavits, and the reports from her experts. When
considered as a whole, this evidence does not amount to a persuasive showing that her Miller-
Fisher syndrome lasted more than six months.
As stated much earlier, Congress imposed a requirement that petitioners in the Vaccine
Program establish five elements. Often the element disputed in causation-in-fact cases is
causation (42 U.S.C. § 300aa–11(c)(1)(C)) and causation is an issue here. But, in other cases,
severity (42 U.S.C. § 300aa–11(c)(1)(D)) is disputed. When petitioners do not meet the severity
requirement, special masters find that petitioners are not entitled to compensation. See Williams
v. Sec’y of Health & Hum. Servs., 178 Fed. Cl. 551 (2025) (denying motion for review of
special master’s decision finding that petitioner did not establish severity and addressing public
policy concerns); Weiss v. Sec’y of Health & Hum. Servs., 177 Fed. Cl. 238 (2025) (denying
motion for review of special master’s decision finding that petitioner’s Guillain-Barré syndrome
did not last six months); Shanes v. Sec’y of Health & Hum. Servs., No. 20-1411V, 2024 WL
4234975 (Fed. Cl. Sep. 4, 2024) (denying motion for review of special master’s decision that
petitioner’s Miller-Fisher syndrome did not last six months).
VI. A Hearing Is Not Required
The foregoing analysis is based upon a review of the entire record. Nevertheless, at
various points, Ms. Gibbons suggests that a hearing would be appropriate. E.g. Pet’r’s Br. at 1,
14; Pet’r’s Reply at 4 n.1.
When both parties have had a fair opportunity to present their evidence and their
arguments, special masters may resolve the case based upon the papers. See Kreizenbeck v.
Sec'y of Health & Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2020).
Here, as recounted in the procedural history, Ms. Gibbons has enjoyed multiple
opportunities to demonstrate that she met the severity requirement. The Secretary alerted Ms.
Gibbons that severity was disputed more than five years ago. Resp’t’s Rep., filed July 12, 2019,
at 9-10. Dr. Steinman’s first attempt to show a sequela to the Miller-Fisher syndrome was to
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identify Ms. Gibbons’s report of tingling in her jaw. Exhibit 10 at 36. This opinion was easily
rebutted by Dr. Jamieson. Exhibit A at 11-12.
After this round of expert reports, Ms. Gibbons added an affidavit saying that she
experienced leg cramps. Exhibit 48. That affidavit was a foundation for Dr. Steinman’s second
report, which was devoted to severity. Exhibit 49.
The March 22, 2021 Tentative Finding stated that Ms. Gibbons was unlikely to prevail
upon her arguments that she satisfied the six-month requirement. But, this Tentative Finding did
not stop Ms. Gibbons from presenting more evidence and more arguments.
In the briefing stage, Ms. Gibbons presented another affidavit, which presented more
information from Ms. Gibbons about severity. Exhibit 56. She also attempted to reinforce her
arguments by presenting another report from Dr. Steinman. This report from Dr. Steinman
largely repeats his previously expressed opinions regarding severity but adds the idea that Ms.
Gibbons’s peripheral neuropathy might have caused heat sensitivity. Exhibit 63. Finally, Ms.
Gibbons advocated through both a primary brief and a reply brief. These memoranda have been
reviewed multiple times.
Because, in part, Ms. Gibbons requested a hearing, the undersigned proposed a series of
questions for her to answer. Order, issued June 6, 2024. The posing of written questions with
the expectation of receiving written answers was used to allow Ms. Gibbons a chance to review
her medical records. The posing of written questions gave Ms. Gibbons an opportunity to
consult her medical records and to think carefully about how she answered the questions. Thus,
arguably, the response to written questions produced answers that are more accurate than if Ms.
Gibbons testified orally and answered questions spontaneously without going through her
medical records. Ms. Gibbons presented her answers in the affidavit. Exhibit 69. Thus, her
request to testify has been granted, although she testified in writing, not orally.
Next, Ms. Gibbons was permitted to raise a new argument regarding her anxiety and
depression in a supplemental brief. This practice is usually not allowed. See SmithKline
Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1320 (Fed. Cir. 2006) (stating that arguments
not raised in primary briefs are ordinarily waived). She was allowed the final word on this topic.
Pet’r’s Suppl. Reply, filed Sep. 19, 2025.
Given this extensive development, which occurred over multiple years, it is difficult to
imagine what additional evidence Ms. Gibbons could present orally at a hearing. She has been
permitted to submit whatever evidence she wished, including affidavits to present her account.
The determination that this evidence does not demonstrate that her Miller-Fisher syndrome lasted
six months reflects the quality of the evidence, not a procedural obstacle.
VII. Conclusion
Ms. Gibbons received a dose of the Tdap vaccination and developed Miller-Fisher
syndrome within about one month. Ms. Gibbons could understandably interpret this sequence as
one meaning that the Tdap vaccination caused her to suffer Miller-Fisher syndrome.
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The Miller-Fisher syndrome required Ms. Gibbons to be hospitalized for approximately
five days. With the benefit of some intense treatments, Ms. Gibbons essentially recovered from
the Miller-Fisher syndrome within about three months. This recovery is fortunate for Ms.
Gibbons’s well-being.
Unfortunately, for purposes of the litigation, Ms. Gibbons’s relatively quick recovery
precludes her from meeting one of the requirements for compensation, which is the adverse
reaction be severe enough to last six months. Without a preponderant showing on this element,
Ms. Gibbons cannot receive compensation.
The Clerk's Office is instructed to enter judgment in accord with this decision unless a
motion for review is filed. Information about filing a motion for review, including the deadline,
can be found in the Vaccine Rules, which are available on the website for the Court of Federal
Claims.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
31