Woods v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-897V
Filed: December 6, 2022
PUBLISHED
Special Master Horner
TIMOTHY WOODS,
Petitioner, Finding of Fact; influenza (flu)
v. vaccine; optic neuritis;
diagnosis.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Mark Theodore Sadaka, Law Offices of Sadaka Associates, LLC, Englewood, NJ, for
petitioner.
Mary Eileen Holmes, U.S. Department of Justice, Washington, DC, for respondent.
FINDING OF FACT 1
On June 30, 2017, petitioner filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012) 2, alleging that as a result of an
influenza (“flu”) vaccination he received on October 11, 2014, he suffered orbital eye
pain, decreased vision, vision loss, and optic neuritis. (ECF No. 1.) Alternatively,
petitioner alleges the subject flu vaccination significantly aggravated these conditions.
(Id.)
Respondent recommended that compensation be denied, arguing, inter alia, that
there is not preponderant evidence to support a finding that petitioner’s symptoms are
due to optic neuritis. (ECF No. 14, p. 6.) On March 30, 2021, a fact hearing was held
1
Because this document contains a reasoned explanation for the special master’s action in this case, it
will be posted on the United States Court of Federal Claims’ website in accordance with the E-
Government Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of
Electronic Government Services). This means the document will be available to anyone with access
to the Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to
redact medical or other information the disclosure of which would constitute an unwarranted invasion of
privacy. If the special master, upon review, agrees that the identified material fits within this definition, it
will be redacted from public access.
2
Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10-34.
1
regarding the diagnosis issue in this case. For the reasons described below, I now find
that petitioner has not preponderantly established that he suffered optic neuritis.
I. Procedural History
This case was initially assigned to Special Master Millman. (ECF No. 4.)
Petitioner filed medical records in support of his claim on July 7, 2017, and an affidavit
on October 26, 2017. (ECF Nos. 6, 9.) After reviewing petitioner’s materials,
respondent filed his Rule 4(c) report contesting entitlement on March 16, 2018. (ECF
No. 14.) Respondent argued, inter alia, that petitioner failed to establish that his
symptoms were caused by optic neuritis. (Id. at 6.)
In response to respondent’s Rule 4(c) report recommending against
compensation, petitioner filed a report from neuroimmunologist Lawrence Steinman,
M.D., on June 29, 2018. (ECF No. 18; Ex. 8.) On November 30, 2018, respondent filed
a responsive report from neuro-ophthalmologist Marc A. Bouffard, M.D. (ECF No. 21;
Ex. A.) Respondent also filed a responsive report from immunologist J. Lindsay
Whitton, M.D., Ph.D., on December 13, 2017. (ECF No. 23; Ex. C.) Petitioner then filed
a supplemental report from Dr. Steinman on February 22, 2019. (ECF No. 28; Ex. 36.)
On April 3, 2019, respondent filed supplemental reports from Dr. Bouffard and Dr.
Whitton. (ECF Nos. 34, 35; Exs. G, H.)
The case was subsequently reassigned to my docket on June 6, 2019. (ECF No.
37.) At the request of petitioner, I held a Rule 5 conference with the parties on October
8, 2019. (ECF No. 39.) During the conference, I noted that both of respondent’s
experts, Drs. Bouffard and Whitton, highlighted a statement from petitioner’s neuro-
ophthalmologist Matthew Thurtell, M.D, in which he stated, “Based on the history, I
suspect [petitioner] had an attack of optic neuritis.” (Id. at 1 (citing Ex. A, p. 3; Ex. C, p.
3).) Although Dr. Whitton stressed that Dr. Thurtell’s phrasing did not constitute a
diagnosis, I did not find it accurate to assert that a diagnosis was not made. (Id.)
However, I cautioned that this “does not mean that the basis for diagnosis is beyond
challenge[.]” (Id. at 1-2.) I further noted petitioner’s nine-month delay in seeking
treatment makes it more difficult “to assess . . . the nature of petitioner’s optical
condition.” (Id. at 2.) Given the sparse factual record in this case and that petitioner’s
condition appears to be relatively mild, I encouraged the parties to explore litigative risk
settlement and recommended that if the parties wished to continue litigation that
petitioner seek a report from a neuro-ophthalmologist to provide a more in-depth
rebuttal to Dr. Bouffard and/or undergo neuroimaging. (Id. at 3.)
On December 10, 2019, respondent filed a status report indicating that he was
not interested in settlement negotiations and intended to continue defending the case.
(ECF No. 41.) Thereafter, on August 7, 2020, petitioner submitted an expert report from
ophthalmologist Todd Allen Lefkowitz, M.D. (ECF No. 54; Ex. 40.) On the same date,
petitioner filed a status report indicating that he decided not to undergo neuroimaging.
(ECF No. 55.) On October 19, 2020, respondent submitted a supplemental report from
Dr. Bouffard responding to Dr. Lefkowitz. (ECF No. 59; Ex. J.) Petitioner subsequently
2
filed a status report requesting that the case be scheduled for an entitlement hearing.
(ECF No. 60.)
I held a status conference with the parties on December 4, 2020. (ECF No. 61.)
I advised that “it may be reasonable to first resolve on the written record the question of
whether there is preponderant evidence that petitioner suffered optic neuritis” before
proceeding to an entitlement hearing. (Id.) However, I noted that “petitioner may wish
to have an opportunity to testify himself and so a more limited fact hearing may also be
appropriate before proceeding to such a fact finding.” (Id.) I added that “following the
fact hearing, the parties would be permitted to consult with their experts to determine
whether they wish to submit supplemental expert reports before resolving the question
of diagnosis on the written record.” (Id. at n.1.) Shortly thereafter, the parties confirmed
availability for a fact hearing in March 2021. (ECF No. 62.)
On January 19, 2021, I issued a prehearing order setting a video fact hearing for
March 30, 2021, wherein I indicated that prehearing submissions were not required but
that the parties could file a joint submission clarifying any issues if they wished. (ECF
No. 63.) Respondent then filed an individual prehearing submission on March 23, 2021,
arguing for the dismissal of petitioner’s case. (ECF No. 64.) On the same date,
petitioner moved to strike respondent’s prehearing submission because it was not jointly
filed as described in the prehearing order. (ECF No. 67.) Respondent filed his
response to petitioner’s motion on March 29, 2021 (ECF No. 68), and petitioner filed his
reply on the same date (ECF No. 69). In his response, respondent deferred to the
court’s discretion regarding petitioner’s motion to strike. (Id.) However, he emphasized
his desire to preserve his argument for appeal that he should have been permitted to
present testimony from his expert, Dr. Bouffard, because the fact hearing was intended
to focus on the question of diagnosis. (Id.) Respondent indicated that “he was
amenable when the court proposed a fact hearing on the issue of diagnosis” but
represented that he “was not aware that expert testimony on the issue of diagnosis
would not be heard.” (Id. at 2.)
I issued an order granting petitioner’s motion to strike on March 29, 2021. (ECF
No. 70.) I noted that although the “fact hearing is prompted by the idea of resolving
diagnosis as a threshold question as respondent suggests, the purpose of the hearing is
only to elicit the fact testimony petitioner may additionally wish to have considered.” (Id.
at 2.) I stressed that the prior order proposing the fact hearing explicitly stated that the
fact hearing would not constitute the close of the evidentiary record regarding diagnosis
and that the parties would be permitted to continue the exchange of expert reports
before resolving petitioner’s diagnosis on the written record. (Id. (citing ECF No. 61,
n.1).) I concluded that respondent’s request to elicit testimony from Dr. Bouffard was
premature and indicated that if respondent still felt expert testimony was necessary to
resolve the issue of diagnosis following the opportunity to submit supplemental expert
reports, respondent should raise such an argument at that time. (Id.)
A fact hearing was held on March 30, 2021, at which petitioner and his wife,
Tonya Woods, testified. (ECF No. 73 (Transcript of Proceedings (“Tr.”)).) Following the
3
hearing, petitioner filed outstanding medical and employment records identified during
the hearing and a statement of completion. (See ECF Nos. 71, 74, 81-83.) The parties
subsequently conferred regarding the need for supplemental reports. (ECF No. 84.)
Respondent expressed interest in filing a supplemental report, and petitioner indicated
his desire to reserve the right to file a supplemental report following the submission of
respondent’s expert report. (Id.) On October 15, 2021, respondent filed a supplemental
report from Dr. Bouffard. (ECF No. 86; Ex. L.) Petitioner requested a status conference
to determine next steps in the case. (ECF No. 87.)
On March 1, 2022, I held a status conference with the parties. (ECF No. 88.) I
shared my view that the factual record had been sufficiently developed to fairly resolve
the issue of diagnosis. (Id. at 1.) I also indicated that my preliminary view that
entitlement in this case should also be resolved on the written record pursuant to
Vaccine Rule 8(d). (Id.) The parties provided input on whether the case should
proceed directly to a comprehensive resolution of entitlement or whether it would be
appropriate to first issue a fact finding regarding the issue of diagnosis. (Id.)
Respondent expressed a preference for first issuing a finding of fact regarding diagnosis
and noted that he would not revisit his settlement posture without guidance on the
threshold issue. (Id.) Conversely, petitioner indicated a preference for proceeding to
resolution of entitlement pursuant to Vaccine Rule 8(d). (Id.) Petitioner expressed
concern that issuance of a finding of fact would not guarantee productive settlement
discussions and could delay resolution of the case. (Id.) However, on March 30, 2022,
the parties filed a joint status report indicating that petitioner was open to either
proposed course of action. (ECF No. 89.) Respondent reiterated his preference for a
briefed finding of fact on diagnosis. (Id.)
The parties filed simultaneous briefs regarding the factual issue of diagnosis on
July 1, 2022. (ECF Nos. 92, 93.) Concurrent with his initial brief, petitioner filed a
medical article examining optic disc cupping following optic neuritis. (ECF No. 91; G.
Rebolleda et al., Optic Disc Cupping After Optic Neuritis Evaluated with Optic
Coherence Tomography, 23 EYE 890 (Ex. 47).) On September 2, 2022, the parties
submitted concurrent responsive briefs. (ECF Nos. 95, 97.) Contemporaneous with his
responsive brief, respondent submitted a supplemental expert report from Dr. Bouffard.
(ECF No. 96; Ex. M.)
Petitioner moved to strike respondent’s responsive brief and Dr. Bouffard’s
supplemental expert report on September 2, 2022. (ECF No. 98.) On September 7,
2022, respondent filed a response to petitioner’s motion and a cross-motion to strike the
Rebolleda et al. medical article that was newly filed with petitioner’s initial brief. (ECF
No. 99.) Petitioner filed his reply on September 7, 2022. (ECF No. 100.)
This matter is now ripe for a finding of fact regarding the issue of diagnosis as
well as a ruling on the parties’ competing motions to strike the additional evidence filed
with their respective briefs.
4
II. Factual History
a. As Reflected in Medical Records
Petitioner was thirty-six years old when he received the flu vaccine on October
11, 2014. (Ex. 4, p. 1.) He received the flu vaccine at UnityPoint Health Jones
Regional Medical Center, where he worked as a respiratory therapist. (Id.) Petitioner’s
pre-vaccination medical history is significant for depression, seasonal affective disorder,
stress, cigarette smoking, respiratory infections, and gastroesophageal reflux disease.
(See, e.g., Ex. 1., p. 1; Ex. 2, pp. 19-21, 28-29; Ex. 3, pp. 9, 14.) Although petitioner
wore glasses for myopia (nearsightedness) prior to vaccination, he did not appear to
have any significant preexisting eye problems. (See Ex. 44, p. 7 (routine eye
examination on October 3, 2012); see also Ex. 3, p. 9 (Dr. Thurtell noting petitioner’s
history of myopia).
Nearly nine months after vaccination, on June 29, 2015, petitioner sought care
from optometrist Bryan Hoke, O.D. (Ex. 44, p. 5.) Petitioner reported a nine-month
history of headaches, blurry vision and decreased color vision in the left eye, and pain in
his left eye and left temple. (Id.) Petitioner’s eye examination was normal. (Id.) Dr.
Hoke referred petitioner to the Wolfe Eye Clinic for further evaluation. (Id. at 5, 2.)
On July 6, 2015, petitioner presented to ophthalmologist LeAnn Larson, M.D., at
the Wolfe Eye Clinic with complaints of poor color vision, difficulty seeing at night, left
orbital pain, and left eye pain. (Ex. 1, p. 1.) Petitioner reported difficulty seeing red and
green from his left eye as well as sinus pressure with radiation to the left temple area
and the left side of his neck. (Id.) Petitioner described periorbital and temporal pain.
(Id.) Dr. Larson indicated that petitioner had localized discomfort and could “create
some discomfort if he presses in the middle of his brow” or “over the left nasal aspect of
his nose.” (Id.) Petitioner also reported that “his blood pressure gets high at times.”
(Id.) Dr. Larson noted that petitioner’s symptoms began after receiving the flu vaccine
nine months prior. (Id.) She further noted that nine months prior, petitioner experienced
left eye pain for about one day, after which petitioner’s “vision seemed to decrease for
about a month.” (Id.) After that point, petitioner reported that his vision remained
largely the same. (Id.) However, he explained that his vision would become blurry
when he got angry or when he mowed the lawn. (Id.) He also described an episode of
eye pain “[t]hat lasted a couple of days a couple of weeks ago.” (Id.) Petitioner shared
his concern that he may have optic neuritis based on his own internet research. (Id.)
During the visit, Dr. Larson performed a comprehensive eye examination. Dr.
Larson found that petitioner’s vision was “excellent,” measuring 20/20 in the right eye
and 20/25 in the left eye. (Ex. 1, pp. 1-2.) The Ishihara Test, which measures color
vision, revealed normal color vision in both of petitioner’s eyes with petitioner correctly
identifying all color plates used in the test. (Id. at 2.) Dr. Larson noted that petitioner’s
pupils were “[e]qual, round, and normally reactive” and did not show evidence of
Relative Afferent Pupillary Defect (“RAPD”). (Id.) Petitioner’s intraocular pressure in
both eyes was normal. (Id.) However, Dr. Larson observed that the optic nerve fiber
5
layer in petitioner’s left eye was thinning, which she noted was “more prominent
temporally.” (Id. at 1.) She also documented granular changes in both eyes and “poorly
defined macular reflexes” in petitioner’s left eye. (Id. at 2.) Dr. Larson assessed
petitioner as having insignificant cataracts due to minor peripheral lens opacities,
granular changes in the macula, and retinal pigment epithelium changes. (Id.) She
recommended petitioner receive a neuro-ophthalmology consult. The next day, on July
7, 2015, petitioner called Dr. Larson’s office to add that “[he] did not mention that he has
a sinus infection and is thinking that this has been chronic for 9 months.” (Id. at 11.)
Over the next few months, petitioner saw his primary care physician, Charles
Vernon, for complaints unrelated to his vision problems. On August 4, 2015, petitioner
visited Dr. Vernon for a spot on the back of his throat. (Ex. 2, p. 14.) The review of
systems for this visit was positive for subjective visual disturbances, and Dr. Vernon
noted that petitioner had seen an ophthalmologist. (Id. at 16.) The next month, on
September 29, 2015, petitioner returned to Dr. Vernon for an upper respiratory tract
infection. (Id. at 9-10.) Petitioner reported that he resumed smoking about a pack of
cigarettes per day about eight or nine months prior when his wife had a stroke. (Id. at
11.) He also reported being under increased stress due to his wife’s health issues and
nursing school responsibilities and requested “something to help him with the stress.”
(Id. at 11-12.) On October 28, 2015, petitioner again visited Dr. Vernon for his chronic
allergic rhinitis. (Id. at 5.) At this visit, Dr. Vernon was primarily concerned about
petitioner’s stress level and cigarette smoking. (Id. at 5-6.) Under review of systems,
Dr. Vernon noted that petitioner was scheduled for a neuro-ophthalmology consult “to
evaluate for the possibility of an optic neuritis disorder.” (Id. at 8.)
On November 4, 2015, several months after petitioner’s ophthalmology visit with
Dr. Larson, petitioner saw neuro-ophthalmologist Matthew Thurtell, M.D. (Ex. 3, p. 9.)
Petitioner reported that after receiving the flu vaccine one year earlier, he experienced a
headache about one or two days after the shot, followed by progressively worsening
ability to see color and cloudy vision “over days.” (Id.) Petitioner explained that these
symptoms lasted for about five months before they improved to the point where it was
not “as noticeable.” (Id.) He described flares of decreased vision associated with
exercise and frustration. (Id.) He also reported experiencing left orbital and temple pain
similar to the headache he had after the flu shot a couple of times a week. (Id.) Dr.
Thurtell noted that petitioner’s description of symptoms was consistent with “a classic
Uhthoff phenomenon” in his left eye. (Id. at 14.) He also documented petitioner’s
history of smoking cigarettes. (Id. at 10.) Upon examination, petitioner’s vision
measured 20/20 in both eyes. (Id. at 11, 14.) Additionally, petitioner again correctly
identified all fourteen color plates used in the Ishihara Test, though he informed Dr.
Thurtell that “it is more difficult to read the color plates” in his left eye. (Id.) Petitioner’s
examination revealed no evidence of APD. (Id.) Dr. Thurtell noted that petitioner’s left
eye had a “[s]luggish” pupil response (id. at 11), but in another note from the same visit
recorded that his pupils were “briskly reactive” without evidence of RAPD (id. at 14). He
also observed “mild temporal rim pallor” in petitioner’s left disc. (Id. at 12.)
6
While at Dr. Thurtell’s office, petitioner underwent an Optical Coherence
Tomography (“OCT”) scan of the optic nerves, which revealed inferotemporal retinal
nerve fiber layer (“RNFL”) thinning and diffuse ganglion cell layer (“GCL”) thinning in
petitioner’s left eye. (Ex. 3, pp. 13, 14.) Dr. Thurtell noted that petitioner’s “neuro-
ophthalmic evaluation showed findings consistent with a mild optic neuropathy” in the
left eye.” (Id. at 14.) He stated, “Based on the history, I suspect [petitioner] had an
attack of optic neuritis [in the left eye].” (Id.) He further noted that “[t]he attack began
shortly after a flu vaccine and, thus, the attack may have been vaccination-related.”
(Id.) Dr. Thurtell specifically added “[o]ptic neuritis, left” to petitioner’s active problem list
and included “[o]ptic neuritis, left” in the assessment section of the encounter with
accompanying ICD billing codes. (Id. at 10, 13.) He recommended a brain MRI with
contrast “to evaluate for underlying demyelinating disease,” but petitioner indicated that
he preferred not to pursue a brain MRI because he was not experiencing other
neurological symptoms at that time. (Id. at 14.)
Petitioner returned to Dr. Vernon on January 27, 2016. (Ex. 2, p. 2.) During the
visit, petitioner requested Dr. Vernon sign a release for him to abstain from future flu
vaccines due to petitioner’s concern that the flu vaccine caused his attack of optic
neuritis. (Id. at 4.) Dr. Vernon noted that it was a “reasonable request” but believed
there were other factors that could have contributed to petitioner’s condition. (Id.) Dr.
Vernon opined that petitioner’s cigarette use was “probably a more common cause of
optic neuritis” and noted that petitioner’s blood pressure was slightly elevated. (Id.)
Over a year later, on March 30, 2017, petitioner presented to Peterson Eye Care.
(Ex. 6, p. 1.) Petitioner’s eye examination indicated normal vision, with both eyes
measuring 20/20. (Id.) The one-page handwritten record appears to recommend
petitioner follow up with a neuro-ophthalmologist for optic neuritis. (Id.)
On December 1, 2017, petitioner followed up with Dr. Larson at the Wolfe Eye
Clinic for ongoing intermittent left eye pain. (Ex. 42, p. 1.) Petitioner reported episodes
of blurry vision and difficulty seeing colors. (Id. at 1-2.) Dr. Larson performed an OCT
scan, which showed cup-to-disc asymmetry with both eyes being thin but the left eye
thinner than the right. (Id. at 2.) She recommended petitioner follow up with neuro-
ophthalmology. (Id.)
Petitioner did not return to the Wolfe Eye Clinic until February 18, 2020, when he
saw Cory Bower, O.D. (Ex. 42, p. 4.) Petitioner reported that his vision in his left eye
remained “slightly dim” but denied any pain. (Id.) Petitioner underwent another OCT
scan, which again showed abnormal RNFL inferotemporal thinning in his left eye. (Id. at
5.) Dr. Bower noted that this finding is consistent with optic neuritis. (Id.) He concluded
that petitioner’s condition was “stable” and “[i]nsignificant” in terms of overall severity.
(Id. at 5, 6.)
Petitioner did not submit any medical records relevant to his condition beyond
February 18, 2020.
7
b. As Reflected in Petitioner’s Affidavit
Petitioner filed an affidavit on October 26, 2017. (Ex. 7.) He averred that prior to
receiving the flu vaccine on October 11, 2014, he was in good health. (Id. at 1.) At the
time of vaccination, petitioner was working full-time as a respiratory therapist and
attending nursing school as an evening student. (Id.) He received the flu vaccine
because it was required by his employer. (Id.) He attested that after receiving the flu
vaccine, he started to feel pain around his eyes and in his forehead. (Id.) Additionally,
it became difficult for him to see at night while driving and to differentiate between red
and green colors. (Id.) Petitioner averred that these symptoms began “in October
2014.” (Id. at 2.)
Although petitioner attested that the onset of his symptoms began in October
2014, he explained that he delayed seeking treatment for several reasons. 3 (Id.)
Petitioner explained that his wife unexpectedly had a stroke on January 1, 2015, “which
left her hospitalized for a long period of time and suffering from permanent effects.” (Id.)
He averred that prior to her stroke, his wife was the primary caregiver of their children
and “took care of all aspects involving [their] household.” (Id.) Following his wife’s
stroke, petitioner attested that he became the primary caregiver for his wife and
children. (Id.) Additionally, petitioner stated that he took a leave of absence from his
job as a respiratory therapist to care for his family. (Id.)
Petitioner explained that once he returned to work at the Jones Regional Medical
Center, he “informally consulted about [his] symptoms with doctors and nurses.” (Id.)
Petitioner stated that he “saw no need to make a formal appointment with a specialist”
because he “informally interacted and consulted with doctors and nurses about [his]
symptoms on a frequent basis.” (Id.) He also noted that his symptoms did not get
worse during the winter of 2014 and spring of 2015. (Id.) Given that his symptoms
“remained relatively constant,” he did not feel inclined to see a specialist. (Id.)
Petitioner stated that when his symptoms progressed in June 2015 and his personal life
“had stabilized,” he made time to visit an eye specialist. (Id.)
c. As Reflected in Testimony
Petitioner testified prior to receiving the flu vaccine on October 11, 2014, he was
in good health, though he got bronchitis once a year and started wearing prescription
glasses in his twenties. (Tr. 34.) He testified that he received the flu vaccine because
both his employer and his nursing program recommended that healthcare providers
receive the flu vaccine to protect patients. (Id. at 9.) After receiving the flu vaccine,
petitioner testified that he did not remember any initial side effects. (Id. at 10.) He
recalled that “a week or two” after receiving the vaccine, he had difficulty seeing green
while attending a sporting event. (Id.) He described his color vision in his left eye as
“disintegrating.” (Id.) After that point, he began having difficulty seeing red. (Tr. 10.)
3
Petitioner averred that he did not seek treatment for his vision problems until July 6, 2015, when he saw
Dr. Larson. (Ex. 7, p. 2.) However, the medical records indicate that he first visited Dr. Hoke with
complaints of blurry vision and difficulty seeing colors on June 29, 2015. (Ex. 44, p. 5.)
8
Following the issues with color vision, petitioner testified that he began experiencing
orbital pain around his left eye and episodes where it felt like he was opening his eye
underwater. 4 (Id. at 11.)
Although petitioner did not seek treatment for several months after he first
noticed symptoms, he recalled speaking with his wife and nurses and doctors at the
Jones Regional Medical Center about his vision problems. (Tr. 11.) Petitioner stated
that his coworkers advised him to “get seen outside of the facility.” (Id. at 12.)
Petitioner testified that he delayed seeking treatment for his eye problems for several
reasons, including his fear that something was “seriously wrong” and his competing
work and school responsibilities. (Id. at 13.) However, he averred that the primary
reason he delayed treatment was due to his wife’s stroke on January 1, 2015. (Id.)
Petitioner testified that the stroke left his wife with several physical disabilities, requiring
him to become the primary caretaker for his wife and their two children. (Id. at 16, 18.)
Prior to her stroke, petitioner’s wife took care of their two children and performed
household chores. (Tr. 14, 18.) Petitioner testified that following his wife’s stroke, he
took six to eight weeks of leave from work and briefly delayed returning to nursing
school for the spring 2015 semester. (Id. at 17-18; 40-41, 50.) He testified that he
returned to school by the end of January and resumed work in either February or March
2015. (Id. at 17-18, 50.)
During this time, petitioner was more focused on his wife and household
responsibilities than on his vision issues. (Tr. 19.) He stated that his orbital pain was
not constant, though at times it was severe, and he periodically experienced sudden
bouts of cloudy vision “depending on [his] stress level.” (Id.) His color vision remained
the same. (Id.)
Petitioner testified that after he finished his nursing program at Kirkwood
Community College in mid-May 2015, he made an appointment to address his eye
problems. (Tr. 21.) He recalled seeing an optometrist in June 2015 and getting a
referral to the Wolfe Eye Clinic. (Id. at 21-22.) When petitioner first saw Dr. Larson at
the Wolfe Eye Clinic, he recalled being “scared” after Dr. Larson’s “demeanor changed”
during his eye examination. (Id. at 22.) He testified that Dr. Larson told him that he
could have optic neuritis, though she was unsure, and that he needed to see a neuro-
ophthalmologist to obtain a diagnosis. (Id. at 23.) Petitioner explained that he then had
to wait for an available appointment with a neuro-ophthalmologist at another facility. (Id.
at 26.)
During petitioner’s appointment with Dr. Thurtell in November 2015, petitioner
recalled Dr. Thurtell advising him that he had optic neuritis and that “in his experience,
the influenza vaccine could be linked to this.” (Tr. 26; see also id. at 58.)
At the time of the hearing, petitioner testified that he did not recall the last time he
experienced eye pain or blurry vision and that his color vision had improved
4
Petitioner later distinguished his orbital pain from sinus pressure associated with the sinus infection he
was experiencing at the time of his visit to Dr. Larson on July 6, 2015. (Tr. 57.)
9
significantly, though he still struggled with red and green colors appearing dull. (Tr. 27.)
He further testified that his right eye “does a really good job compensating for [his] left
eye.” (Id.) Petitioner stated that he was a current smoker at the time of the hearing.
(Id. at 55.) Additionally, he testified that he was diagnosed with high blood pressure and
that he takes hydrochlorothiazide, a blood pressure medication. (Id. at 38.)
Petitioner’s wife, Tonya Woods, also provided testimony. (Tr. 60-67.) Ms.
Woods’s understanding is that petitioner was diagnosed with optic neuritis. (Id. at 61.)
She recalled petitioner having trouble seeing colors and experiencing eye pain “once in
a while” after receiving the flu vaccine in October 2014. (Id.) She noted that petitioner
typically avoids dealing with health concerns and stress. (Id. at 62.) She testified that
she “couldn’t do anything” after her stroke in 2015 and that petitioner had to take over
all household and childcare responsibilities. (Id. at 64, 67.)
III. Expert Opinions 5
a. Petitioner’s Experts
i. Lawrence Steinman, M.D.
In support of his claim, petitioner presented an expert opinion by
neuroimmunologist Lawrence Steinman, M.D. Dr. Steinman received his medical
degree from Harvard in 1973. (Ex. 9, p. 1.) He is board-certified in neurology and has
practiced adult and pediatric neurology at Stanford University. (Id. at 2; Ex. 8, p. 1.) Dr.
Steinman has treated patients, both adults and children, who suffered from various
forms of inflammatory neuropathy, including transverse myelitis, acute disseminated
encephalomyelitis, neuromyelitis optica, multiple sclerosis, and others. (Ex. 8, p. 1.) He
is currently a professor of neurology at Stanford University. (Id.; Ex. 9, p. 1.) Dr.
Steinman’s research focuses on how the immune system attacks the nervous system,
and he has published on various topics involving vaccines and neurological disorders,
including molecular mimicry. (Ex. 8, p. 1; Ex. 9, pp. 5-46.) He holds numerous
American and European patents, including several U.S. patents relating to vaccines.
(Ex. 8, p. 3; Ex. 9, pp. 2-3.)
The bulk of Dr. Steinman’s expert reports focused on the mechanism of
causation. (See generally Ex. 8; Ex. 36.) Dr. Steinman only briefly discussed the
diagnosis dispute in his first supplemental report. In response to Dr. Bouffard’s opinion
on diagnosis, Dr. Steinman stressed that “Dr. Bouffard opines from a different context
than that of the treating physicians.” (Ex. 36, p. 1.) Dr. Steinman deferred to the
diagnosis made by Dr. Thurtell, the “boots on the ground” treating neuro-
ophthalmologist. (Id.)
5
The expert reports offered by the parties discussed issues beyond the diagnosis dispute. For purposes
of this fact finding, only aspects of the expert reports related to diagnosis are discussed.
10
ii. Todd A. Lefkowitz, M.D.
Petitioner also presented an expert report from board-certified ophthalmologist
Dr. Lefkowitz. (Ex. 40.) Dr. Lefkowitz received his medical degree from New York
University School of Medicine in 1977 and completed an ophthalmology residency at
Georgetown University in 1981. (Id. at 1; Ex. 41, pp. 1-2.) He has practiced
ophthalmology since 1981 and received his board certification in 1982. (Ex. 40, p. 1;
Ex. 41, p. 1.) He currently practices as an ophthalmologist at Walman Eye Center as
well as an ophthalmology hospitalist and trauma specialist at Banner Hospitals in
Arizona. (Ex. 41, p. 1.) He also serves as a clinical assistant professor at the University
of Arizona Medical School. (Id.) He performs various types of eye surgeries, including
LASIK and cataract surgeries. (Ex. 40, p. 1.) Dr. Lefkowitz did not discuss any
experience in neuro-ophthalmology in his expert report or curriculum vitae. (See
generally Ex. 40; Ex. 41.)
In response to Dr. Bouffard’s report proposing alternative etiologies for
petitioner’s symptoms, Dr. Lefkowitz asserted that petitioner did not suffer from
ischemic, post-inflammatory, glaucomatous, or toxic etiologies. (Ex. 40, p. 3.) He
explained that these etiologies present with accompanying signs. (Id.) Glaucoma
presents with high intraocular pressure and distinctive visual field defects, post-
inflammatory processes present with peri-orbital pain, ischemic etiologies present with
cardiovascular disease, and toxic etiologies are accompanied by exposure to toxic
substances. (Id.) Regarding glaucoma, he concluded that petitioner’s visual testing did
not suggest glaucoma. (Id.) He concluded that petitioner did not suffer from any other
alternative etiology other than optic neuritis without further explanation. (Id.) He did not
address any of Dr. Bouffard’s specific concerns about petitioner’s presentation being
inconsistent with optic neuritis. (See id.)
b. Respondent’s Experts
i. Marc A. Bouffard, M.D. 6
Respondent offered an expert opinion from Dr. Bouffard, a neurologist who
specializes in neuro-ophthalmology. Dr. Bouffard received his medical degree from
Tufts University School of Medicine in 2012. (Ex. B, p. 2.) He then completed a
neurology residency at Beth Israel Deaconess Medical Center, a neuro-ophthalmology
fellowship at the Massachusetts Eye and Ear Infirmary, and a fellowship in Advanced
General and Autoimmune Neurology at the Massachusetts General Hospital. (Id.; Ex.
A, p. 2.) He currently practices at the Beth Israel Deaconess Medical Center where he
routinely sees patients with optic neuritis. (Ex. A, p. 2.) He has written multiple peer-
reviewed publications in the field of neuro-ophthalmology, including two articles on
neuroimaging modalities in neuro-ophthalmic disease. (Id.; Ex. B, pp. 2-3.)
6
As discussed in a later section, Dr. Bouffard’s supplemental expert report filed as Exhibit M is not being
considered. Therefore, this report is not discussed.
11
As an initial matter, Dr. Bouffard explained the difference between optic
neuropathy and optic neuritis. (Ex. A, p. 4.) He indicated that optic neuropathy refers
broadly to optic nerve dysfunction, while optic neuritis refers specifically to “immune-
mediated inflammation of the optic nerve.” (Id.) He suggested that optic nerve damage
can be caused by several different processes, including but not limited to inflammatory
disorders such as optic neuritis. (Id.)
Regarding the typical clinical course for optic neuritis, Dr. Bouffard noted that “its
presenting features are well defined.” (Ex. A, p. 5.) According to Dr. Bouffard,
individuals suffering from optic neuritis usually suffer pain “centered on and around the
globe” that is exacerbated with eye movements. (Id. at 4.) He explained that optic
neuritis patients typically experience pain “up to a few days” before vision loss occurs
and resolves “within a few days of the onset of vision loss.” (Id.) He opined that pain
lasting longer than seven days after vision loss “should raise suspicion for alternate
diagnoses.” (Id.)
To provide further guidance on the clinical features of optic neuritis, Dr. Bouffard
discussed the optic neuritis treatment trial (“ONTT”), which examined 457 patients from
1988 to 1991. (Ex. A, p. 5.) The ONTT demonstrated that “visual recovery began
within a month of the initial attack” and that “[p]ain is typically present for under a week,
resolving more rapidly than vision loss.” (Id.) Dr. Bouffard opined that ongoing
inflammation is “extremely rare,” and that most individuals experience “discrete attacks.”
(Id.) He further noted that “subtle functional abnormalities of the optic nerve” may
continue after recovery from optic neuritis. (Id.) Specifically, individuals who recover
from optic neuritis may continue to experience “[s]ubtle defects of color vision and
contrast sensitivity.” (Id.) Additionally, patients may have “[e]pisodic visual
deterioration” associated with elevated body temperature, known as Uthoff’s
phenomenon. (Ex. A, pp. 5-6.) Dr. Bouffard emphasized that “Uthoff’s phenomenon is
painless, provoked by high temperature, transient, and not specific to demyelinating
optic neuritis.” (Id. at 6 (emphasis removed).) He also suggested that patients who
recover from optic neuritis typically have mild atrophy of the nerve that may be shown
by RNFL measurements or OCT studies. (Id.)
Although Dr. Bouffard agreed that petitioner “clearly has a mild optic neuropathy
affecting the left eye,” he cautioned that a diagnosis of optic neuritis could not be
“confidently established” due to the sparse factual record. (Ex. A, p. 6; see also Ex. J,
p. 1 (stating that “there is no evidence that petitioner had optic neuritis”) (emphasis
removed).) Dr. Bouffard was particularly concerned that petitioner was not examined
close in time to the onset of his condition and that petitioner never underwent
neuroimaging. (Ex. A, pp. 6, 9.) Given that petitioner was not examined close in time to
onset of his condition, Dr. Bouffard concluded that “the expected course of optic neuritis
could not be objectively confirmed.” (Id. at 9.) Additionally, Dr. Bouffard expressed
concern that petitioner did not undergo neuroimaging to rule out a compressive lesion,
such as an aneurism, optic nerve sheath meningioma, or optic nerve glioma. (Id. at 7,
9.) He also stressed that petitioner’s treaters did not record a detailed history for head
trauma or initiate a work-up for syphilis. (Id.)
12
Dr. Bouffard further opined that petitioner’s clinical presentation was inconsistent
with optic neuritis. Significantly, Dr. Bouffard asserted that the nature of petitioner’s eye
pain did not fit with an optic neuritis diagnosis. (Ex. A, p. 7; Ex. J, pp. 1-2; Ex. L, p. 2.)
Dr. Bouffard noted that “[p]atients with optic neuritis typically have several days of eye
pain, exacerbated by eye movements, preceding or accompanying the onset of visual
abnormalities.” (Ex. A, p. 7.) Dr. Bouffard acknowledged that petitioner reported
experiencing eye pain for about one day at the time of onset of his subjective
dyschromatopsia or visual disturbances, 7 but stressed that petitioner continued to report
frequent orbital pain thereafter. (Id.; see also Ex. J, pp. 1-2 (stressing that “[t]he pain of
optic neuritis is transient and does not recur without another attack”); Ex. L, p. 1 (noting
that the pain with optic neuritis usually lasts for less than a week). Specifically, Dr.
Bouffard referenced petitioner’s visit to Dr. Thurtell over a year after the onset of his
condition during which he reported experiencing episodic eye pain three times a week.
(Ex. J, pp. 1-2; Ex. L, p. 1.) He noted that relapse of optic neuritis would not occur as
frequently as the episodes petitioner reported. (Ex. J, pp. 1-2.) Further, if petitioner
were experiencing frequent attacks of optic neuritis, Dr. Bouffard opined that his
examination at Dr. Thurtell’s office would have shown abnormalities consistent with
optic neuritis attacks. (Id. at 2.)
Additionally, Dr. Bouffard emphasized that petitioner was able to elicit or worsen
his pain through palpation of the “brow” and the “nasal aspect of his nose,” which is
inconsistent with optic neuritis. (Ex. A, p. 7 (citing Ex. 1, p. 1); see also Ex. J, p. 1
(citing Ex. 1, p. 1) (reiterating that petitioner’s pain associated with “pressing on soft
tissue/bony structures around the orbit” is inconsistent with pain caused by optic nerve
inflammation); Ex. L, p. 1 (stating that “[t]ouching the bones of the brow or nose in no
way upsets the optic nerve and is obviously indicative of a source of pain other than
optic neuritis”) (emphasis removed).) Dr. Bouffard offered trochleitis, a supraorbital
neuropathy, or posterior scleritis as more likely causes for the orbital eye pain petitioner
described. (Ex. A, pp. 7, 9.) He also pointed out that petitioner reported sinus
discomfort. (Id. at 7.)
Dr. Bouffard also opined that the appearance of petitioner’s optic nerve did not
comport with a diagnosis of optic neuritis. (Ex. A, p. 7.) While Dr. Bouffard
acknowledged that petitioner had an increased cup to disc ratio in the left eye, he
stressed that this is uncommon in optic neuritis. (Id. (citing William Stewart & Karen
Reid, Incidence of systemic and ocular disease that may mimic low-tension glaucoma,
1(1) J. GLAUCOMA 27 (1992) (Ex. F-11); Jonathan Trobe et al., Nonglaucomatous
excavation of the optic disc, 98 ARCH. OPHTHALMOL. 1046 (1980) (Ex. F-12); see also
7
In a later report, Dr. Bouffard asserted that petitioner’s orbital pain developed weeks after his visual
disturbances initially occurred, while pain with optic neuritis typically precedes or accompanies the onset
of vision loss. (Ex. L, p. 1 (citing Tr. 56).) This is inconsistent with Dr. Bouffard’s earlier
acknowledgement that petitioner experienced eye pain for about one day at the time of onset of vision
complaints. (See Ex. A, p. 7.) However, Dr. Bouffard’s later report followed the fact hearing, during which
petitioner testified that he experienced color disturbances and blurry vision first, followed by orbital pain
weeks later, which is inconsistent with his earlier reports to Dr. Larson and Dr. Thurtell. (Tr. 56; see also
Ex. 1, p. 1; Ex. 3, p. 9.)
13
Ex. J, p. 2; Ex. L, p. 2.) Although increased cup to disc ratio is “an important feature to
recognize in patients with optic neuropathy,” such a finding is more suggestive of
compressive lesions such as aneurysms, optic nerve sheath meningiomas, or tumors
intrinsic to the optic nerve, as well as syphilis. (Ex. A, p. 7.) Dr. Bouffard noted that Dr.
Thurtell suggested an orbital MRI with and without contrast, which would have been
helpful to rule out an indolent compressive lesion, but petitioner declined. (Id.) He
added that traumatic optic neuropathy is another source of cupped optic neuropathy but
noted that petitioner’s treaters did not record any notes regarding the presence or
absence of head trauma. (Id.) Dr. Bouffard maintained that other than petitioner’s
increased cup to disc ratio, his optic nerve showed no abnormal findings. (Ex. L, p. 2.)
Additionally, while Dr. Bouffard acknowledged that RNFL thinning suggests optic nerve
damage, he explained that “it does not indicate any particular etiology.” (Ex. A, p. 6.)
Further, Dr. Bouffard stressed that petitioner’s examinations showed no evidence of
optic neuritis. Specifically, Dr. Bouffard noted petitioner’s examinations revealed normal
visual acuity and color vision, lack of RAPD, and normal visual fields. (Ex. J, p. 2 (citing
Ex. 3, pp. 9-15).)
Regarding Dr. Thurtell’s notation that petitioner’s description of symptoms was
consistent with Uhthoff’s phenomenon, Dr. Bouffard stated that he “would be surprised
to see [Uhthoff’s] in the setting of anger” given that it is associated with body
temperature. (Ex. A, p. 7.) Further, he opined that petitioner’s episodes of visual
disturbances triggered by cutting grass were more likely related to allergic eye
symptoms or ocular surface disease. 8 (Id.) Regardless of whether petitioner’s
symptoms were consistent with Uhthoff’s phenomenon, Dr. Bouffard stressed that
Uhthoff’s phenomenon is “not specific to demyelinating optic neuropathy and has been
reported in other optic neuropathies.” (Id. at 7-8.)
Finally, Dr. Bouffard asserted that “[t]he tempo of petitioner’s vision loss is
unusual for optic neuritis.” (Ex. J, p. 1.; see also Ex. L, p. 1.) Dr. Bouffard noted that
petitioner described monophasic vision loss with no improvement for seven months (Ex.
J, p. 1 (citing Ex. 1, pp. 1-6).) Conversely, most patients with optic neuritis experience
“subacute progressive vision loss for days to a few weeks, then slowly start to improve.”
(Id.) Dr. Bouffard therefore opined that petitioner’s description of intermittent blurry
vision is inconsistent with progressive inflammation of the optic nerve in patients with
optic neuritis. (Ex. L, p. 1 (citing Tr. 10-12).) Thus, Dr. Bouffard concluded that
petitioner’s clinical presentation, his description of symptoms, and his ophthalmologic
examinations do not support a diagnosis of optic neuritis.
8
Dr. Bouffard elaborated that petitioner’s complaints of episodic blurry vision “could easily have been
accounted for by irritation of the cornea” and that petitioner is at higher risk of corneal irritation due to his
history of smoking. (Ex. L, p. 2.) He explained that his suspicion of corneal irritation is further supported
by petitioner’s aggravation of symptoms while cutting grass and petitioner’s use of Visine. (Id. (citing Ex.
44, pp. 2-3.)
14
ii. J. Lindsay Whitton, M.D., Ph.D.
Respondent also presented an expert opinion from immunologist Dr. Whitton.
Dr. Whitton received his medical degree from the University of Glasgow in 1979 and his
doctorate degree in virology also from the University of Glasgow in 1984. (Ex. C, pp. 1-
2; Ex. D, p. 1.) Dr. Whitton has not sought licensure in the United States, nor has he
practiced medicine in the United States. (Ex. C, pp. 2-3.) Dr. Whitton has served as a
professor in the Department of Immunology and Microbiology at the Scripps Research
Institute since 2008. (Ex. D, p. 2.) He has published extensively on the adaptive and
innate immune response and on molecular mimicry. (See id. at 3-15.)
Like Dr. Steinman, Dr. Whitton dedicated most of his discussion to the
mechanism for causation. (See generally Ex. C; Ex. H.) Dr. Whitton deferred to Dr.
Bouffard’s opinion on diagnosis and his expertise in neuro-ophthalmology. (Ex. C, pp.
3-4.) However, Dr. Whitton contended that Dr. Thurtell made only a “speculative
diagnosis” of optic neuritis based on petitioner’s description of events that occurred one
year prior. (Id. (emphasis omitted).) Dr. Whitton emphasized Dr. Thurtell’s language:
“Based on the history, I suspect he had an attack of optic neuritis.” (Id. at 3 (quoting Ex.
3, p. 14) (emphasis in original).) He maintained that “none of petitioner’s physicians
have ever identified any objective clinical signs of optic neuritis.” (Id. at 4.)
IV. Standard of Adjudication
The parties dispute whether petitioner’s symptoms were caused by optic neuritis.
As a threshold matter, a petitioner must establish he suffers from the condition for which
he seeks compensation. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d
1339, 1346 (Fed. Cir. 2010). “The function of a special master is not to ‘diagnose’
vaccine-related injuries, but instead to determine ‘based on the record as a whole and
the totality of the case, whether it has been shown by a preponderance of the evidence
that a vaccine caused the [petitioner]’s injury.’” Andreu v. Sec’y of Health & Human
Servs., 569 F.3d 1367, 1382 (Fed. Cir. 2009) (quoting Knudsen v. Sec’y of Health &
Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)). “Although the Vaccine Act does not
require absolute precision, it does require the petitioner to establish an injury – the Act
specifically creates a claim for compensation for ‘vaccine-related injury or death.’”
Stillwell v. Sec'y of Health & Human Servs., 118 Fed. Cl. 47, 56 (2014) (quoting
42.U.S.C. § 300aa-11(c)). Accordingly, the Federal Circuit has concluded that it is
“appropriate for the special master to first determine what injury, if any, [is] supported by
the evidence presented in the record before applying the Althen test to determine
causation.” Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343, 1353 (Fed.
Cir. 2011).
The process for making determinations in Vaccine Program cases regarding
factual issues begins with consideration of the medical records. § 300aa-11(c)(2). The
special master is required to consider “all [ ] relevant medical and scientific evidence
contained in the record,” including “any diagnosis, conclusion, medical judgment, or
autopsy or coroner’s report which is contained in the record regarding the nature,
15
causation, and aggravation of the petitioner’s illness, disability, injury, condition, or
death,” as well as “the results of any diagnostic or evaluative test which are contained in
the record and the summaries and conclusions.” § 300aa-13(b)(1)(A). The special
master is then required to weigh the evidence presented, including contemporaneous
medical records and testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d
415, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine
whether to afford greater weight to contemporaneous medical records than to other
evidence, such as oral testimony surrounding the events in question that was given at a
later date, provided that such a determination is evidenced by a rational determination).
Petitioner must prove by a preponderance of the evidence the factual circumstances
surrounding his claim. § 300aa-13(a)(1)(A).
In general, contemporaneous medical records “warrant consideration as
trustworthy evidence.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525,
1528 (Fed. Cir. 1993). Accordingly, if the medical records are clear, consistent, and
complete, then they should be afforded substantial weight. Lowrie v. Sec’y of Health &
Human Servs., No. 03-1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12,
2005). Indeed, contemporaneous medical records are generally found to be deserving
of greater evidentiary weight than oral testimony—especially where such testimony
conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also Murphy v.
Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d 1226 (Fed.
Cir. 1992) (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1948)
(“It has generally been held that oral testimony which is in conflict with
contemporaneous documents is entitled to little evidentiary weight.”)), cert. den’d,
Murphy v. Sullivan, 506 U.S. 974 (1992).
Nonetheless, treating physicians’ opinions 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 § 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)
(“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”). As with
expert testimony offered to establish a theory of causation, the opinions or diagnoses of
treating physicians are only as trustworthy as the reasonableness of their suppositions
or bases. The views of treating physicians should also be weighed against other,
contrary evidence also present in the record. Hibbard v. Sec’y of Health & Human
Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious for special master to
weigh competing treating physicians’ conclusions against each other), aff’d, 698 F.3d
1355 (Fed. Cir. 2012); Caves v. Sec'y of Health & Human Servs., 100 Fed. Cl. 119, 136
(2011), aff’d, 463 Fed. App’x 932 (Fed. Cir. 2012); Veryzer v. Sec’y of Health & Human
Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011),
mot. for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed.
App’x 765 (Fed. Cir. 2012).
16
Additionally, there are situations in which compelling oral testimony may be more
persuasive than written records, such as where records are deemed to be incomplete or
inaccurate. Campbell v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006)
(“like any norm based upon common sense and experience, this rule should not be
treated as an absolute and must yield where the factual predicates for its application are
weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are,
themselves, inconsistent, should be accorded less deference than those which are
internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733). When witness testimony is
offered to overcome the presumption of accuracy afforded to contemporaneous medical
records, such testimony must be “consistent, clear, cogent, and compelling.” Sanchez
v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl.
Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-
2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In making a
determination regarding whether to afford greater weight to contemporaneous medical
records or other evidence, such as testimony at hearing, there must be evidence that
this decision was the result of a rational determination. Burns, 3 F.3d at 417.
V. Discussion
As discussed in the procedural history above, there are two outstanding motions
to strike that were filed during the briefing process. As a preliminary matter, it is
necessary to resolve these motions to clarify the record upon which this fact finding will
be made. This is accomplished in section (a) below. Section (b) then addresses the
undersigned’s finding of fact with regard to petitioner’s diagnosis, concluding that there
is not preponderant evidence supporting petitioner’s preferred diagnosis.
a. Petitioner’s Motion to Strike and Respondent’s Cross-Motion to
Strike
Petitioner moved to strike respondent’s responsive brief on diagnosis and Dr.
Bouffard’s supplemental expert report filed as Exhibit M. (ECF No. 98.) Regarding
respondent’s responsive brief, although it was filed by the deadline on September 2,
2022, petitioner indicated that the parties “conferred in good faith and agreed upon filing
the briefs at 1:30 p.m. EST.” (Id. at 1.) Petitioner stated that while petitioner filed his
brief at 1:33 p.m., respondent did not file his brief until 3:44 p.m. “and made no attempt
to reach out to petitioner’s counsel prior to the agreed upon deadline to request an
extension/delay.” (Id.) With respect to Dr. Bouffard’s supplemental report, petitioner
argued that it should be stricken because respondent never shared his intent to file the
report and the action of filing such a report “lacks good faith.” (Id.) Petitioner noted that
“despite conferring with petitioner’s counsel on both the extension of time for the filing of
the briefs and the concurrent filing of [the responsive briefs], respondent’s counsel
never mentioned that [respondent was] seeking and/or planning to file an expert report.”
(Id. at 1-2.) He elaborated that “respondent has repeatedly attempted to add expert
testimony to a factual issue.” (Id. at 2.)
17
In his response to petitioner’s motion to strike, respondent stressed that
petitioner “relied extensively” on the Rebolleda et al. article, which was newly filed with
petitioner’s initial brief on diagnosis. (ECF No. 99, p. 1.) Respondent further noted that
he moved for an extension of time to file his responsive brief on diagnosis on August 1,
2022, citing the need for additional time to allow for “feedback from his expert as to the
new literature petitioner filed with his initial brief.” (Id. (quoting ECF No. 94.)
Respondent asserted that Dr. Bouffard’s supplemental report responds specifically to
the comments regarding optic neuritis contained in petitioner’s initial brief and the
Rebolleda et al. article. (Id.) Respondent argued that petitioner’s motion to strike “is
effectively a motion to exclude.” (Id. at 2.) He maintained that his “actions were
prompted by petitioner’s untimely evidence” and noted that petitioner did not explain
why the Rebolleda et al. article was not provided before briefing. (Id.) In the event the
court finds it necessary to strike respondent’s brief and supplemental expert report,
respondent cross-moved to strike the Rebolleda et al. article as an untimely disclosure.
(Id. at 4.)
In his reply, petitioner stressed that respondent did not put petitioner on notice
that an expert report was forthcoming. (ECF No. 100, p. 1.) He argued that conferring
with an expert prior to filing a brief is a customary practice and does not indicate that the
expert intended to prepare an additional report. (Id.) Petitioner cited the scheduling
order issued on March 1, 2022, which indicated that “the factual record [was] sufficiently
developed to fairly resolve the issue of diagnosis.” (Id. at 2 (citing ECF No. 88, p. 1).)
Petitioner disputed respondent’s contention that he relied extensively on the Rebolleda
et al. article, noting that his initial brief mentioned the article only once. (Id. (citing ECF
No. 93, p. 8.) Petitioner also claimed that the majority of Dr. Bouffard’s supplemental
report does not address the Rebolleda et al. article, but instead discusses other aspects
of petitioner’s initial brief. (Id.) Petitioner further noted that respondent’s responsive
brief discusses Dr. Bouffard’s supplemental report extensively. (Id. at 3.)
Following the fact hearing on March 30, 2021, respondent was afforded the
opportunity to submit an additional supplemental report from Dr. Bouffard. (ECF No. 86;
Ex. L.) As noted by petitioner, during a status conference held on March 1, 2022, I then
later indicated that “the factual record has now been sufficiently developed to fairly
resolve the issue of diagnosis.” (ECF No. 88, p. 1.) Based on the discussion during the
status conference and the notion that the record was ripe for a ruling on diagnosis,
further evidence was not anticipated. (See ECF Nos. 88, 89.) Although petitioner filed
the Rebolleda et al. medical article concurrent with his initial brief, the article was not
interpreted by an expert. Additionally, contrary to respondent’s assertion, petitioner did
not rely heavily on the article in his brief. Instead, he cited it only once throughout the
ten-page brief. (ECF No. 93, p. 8.) Thus, the filing of the Rebolleda et al. article, even if
fairly subject to objection, did not reasonably open the door to the filing of an additional
report from Dr. Bouffard. Thus, that aspect of petitioner’s motion seeking to strike Dr.
Bouffard’s supplemental expert report is granted.
However, given the analysis below, there is clearly no prejudice to respondent in
accepting into evidence the Rebolleda et al. article. Vaccine Rule 8(b)(1) (“In receiving
18
evidence, the special master will not be bound by common law or statutory rules of
evidence but must consider all relevant and reliable evidence governed by principles of
fundamental fairness to both parties.”) Thus, and respondent’s cross-motion is denied.
Finally, petitioner is unpersuasive in further arguing that respondent’s brief
should also be struck. The undersigned’s scheduling order only required that the
simultaneous briefs be filed on the same date and petitioner is not persuasive in
suggesting the two-hour difference in filing times is significant. To the extent
respondent’s brief does discuss Dr. Bouffard’s now struck report, most such references
include alternative citations finding support elsewhere in the record. Those that do not
are easily disregarded and, in any event, respondent’s argumentation does not in itself
constitute evidence.
Accordingly, petitioner’s motion to strike is GRANTED in part and DENIED in
part, and respondent’s cross-motion to strike is DENIED.
b. Finding of Fact as to Diagnosis
Petitioner has not preponderantly established that he suffered optic neuritis. Dr.
Bouffard persuasively explained that petitioner’s clinical presentation is inconsistent with
optic neuritis and it is unlikely that petitioner’s reported eye pain was caused by that
condition. While optic neuritis patients typically experience transient pain before or
accompanying vision loss, petitioner described ongoing orbital pain for several months
following his initial visual disturbance. (See Ex. A, p. 7 (citing Ex. 1, p. 1); Ex. J, pp. 1-2;
Ex. L, p. 1 (citing Tr. 19-20, 56).) Petitioner’s ability to elicit or worsen his orbital pain
through palpation of his brow and nose is also inconsistent with pain associated with
optic neuritis. (Ex. A, p. 7 (citing Ex. 1, p. 1); Ex J, p. 1.) Additionally, petitioner’s
description of ongoing vision loss with no improvement for several months is atypical for
optic neuritis. (Ex. J, p. 1 (citing Ex. 1, pp. 1-6); Ex. L, p. 1.) Further, petitioner’s
episodic blurry vision is inconsistent with progressive inflammation of the optic nerve
seen in patients with optic neuritis. (Ex. L, p. 1 (citing Tr. 10-12).) Although Dr. Thurtell
noted that petitioner’s description of symptoms was consistent with Uhthoff’s
phenomenon, Dr. Bouffard stressed that Uthoff’s phenomenon is not specific to optic
neuritis. (Ex. A, pp. 7-8.) Thus, petitioner’s medical history and treatment course
suggest that his symptoms were not caused by optic neuritis.
Furthermore, objective examinations and testing did not reveal evidence for optic
neuritis. Dr. Bouffard opined that the appearance of petitioner’s optic nerve did not
suggest optic neuritis. (Ex. A, p. 7.) Although petitioner had an increased cup to disc
ratio in his left eye, Dr. Bouffard explained that this abnormality is uncommon among
patients with optic neuritis. (Id. (citing Steward & Reid, supra, at Ex. F-11; Trobe et al.,
supra, at Ex. F-12); Ex. J, p. 2; Ex. L, p. 2.) Dr. Bouffard acknowledged that an
increased cup to disc ratio indicates optic neuropathy but noted that it likely reflects
compressive lesions such as aneurysms, optic nerve sheath meningiomas, or tumors
intrinsic to the optic nerve, or syphilis. (Ex. A, p. 7.) While petitioner’s RNFL thinning
19
suggests optic nerve damage, Dr. Bouffard explained that “it does not indicate any
particular etiology.” (Id. at 6.)
Concurrent with his initial brief, petitioner offered the Rebolleda et al. article to
dispute Dr. Bouffard’s contention that an increased cup-to-disc ratio is uncommon in
optic neuritis. (ECF No. 93, p. 8 (citing Rebolleda et al., supra, at Ex. 47.) However,
petitioner misinterprets Dr. Bouffard’s opinion. Dr. Bouffard did not assert that
cup-to-disc asymmetry is never observed in optic neuritis as petitioner suggests. He
opined that it is not specific to optic neuritis and uncommon as a result of optic neuritis.
(Ex. A, p. 7; Ex. J, p. 2; Ex. L, p. 2.) Consistent with Dr. Bouffard’s observation, the
Rebolleda article begins by acknowledging “[e]ven though optic disc cupping is usually
identified with glaucoma, it may be seen in other, less common optic nerve diseases[.]”
(Rebolleda et al., supra, at Ex. 47, p. 890.) The article further states while cup
asymmetry has been observed in patients with optic neuritis, “the most common change
in the optic nerve head (ONH) after optic neuritis is optic disc pallor[.]” (Id.) The article
qualified its observations by citing another study that found no significant increase in
optic disc cupping among patients with optic neuritis. (Id.) Ultimately, the authors
characterize the study as a first of its kind demonstration that supports inclusion of optic
neuritis as one among many diseases that can cause optic disc cupping. (Id. at 894.)
On the whole, the article does not provide evidence contrary to Dr. Bouffard’s opinion
that the appearance of petitioner’s optic nerve was not necessarily suggestive of optic
neuritis.
Moreover, Dr. Bouffard stressed that petitioner’s ophthalmologic examinations
revealed normal visual acuity and color vision, lack of RAPD, and normal visual fields.
(Ex. J, p. 2 (citing Ex. 3, pp. 9-15.) In fact, Dr. Larson described petitioner’s visual
acuity as “excellent,” and petitioner measured 20/20 in both eyes during Dr. Thurtell’s
visual examination. (Ex. 1, pp. 1-2; Ex. 3, pp. 11, 14.) Further, petitioner correctly
identified all color plates in the Ishihara color test both at Dr. Larson’s office and at Dr.
Thurtell’s office. (Ex. 1, p. 2; Ex. 3, pp. 11, 14.) Thus, based on petitioner’s
ophthalmologic examinations, the evidence preponderates against a finding that
petitioner suffered optic neuritis.
Dr. Lefkowitz only briefly discussed the diagnosis dispute in his report responding
to Dr. Bouffard. (Ex. 40.) He merely concluded that petitioner did not suffer from
ischemic, post-inflammatory, glaucomatous, or toxic etiologies without providing any
explanation other than that petitioner’s visual testing did not indicate glaucoma. (Id. at
3.) Dr. Lefkowitz asserted that petitioner suffered from optic neuritis without offering any
discussion or rebuttal regarding Dr. Bouffard’s specific critiques about petitioner’s
presentation being inconsistent with optic neuritis. (See id.) In any event, Dr.
Bouffard’s opinion is also entitled to more weight given his specialization in neuro-
ophthalmology. Dr. Lefkowitz did not discuss any experience in neuro-ophthalmology.
(See Exs. 40, 41.) In contrast, Dr. Bouffard is board-certified in neurology, completed a
neuro-ophthalmology fellowship at the Massachusetts Eye and Ear Infirmary, and has
written multiple peer-reviewed publications in the field of neuro-ophthalmology. (Ex. A,
pp. 2-3; Ex. B, pp. 2-3.) Given Dr. Bouffard’s experience and additional qualification in
20
neuro-ophthalmology, his opinion regarding petitioner’s clinical presentation and testing
is deserving of greater weight than that of Dr. Lefkowitz.
Petitioner otherwise relies on Dr. Thurtell’s notation as treating physician that he
“suspect[ed] [petitioner] had an attack of optic neuritis.” (Ex. 3, p. 14.) However,
although Dr. Thurtell is a treating physician, his optic neuritis diagnosis does not
outweigh Dr. Bouffard’s far more detailed opinion that petitioner’s presentation and
objective examinations were inconsistent with optic neuritis. The quality of Dr. Thurtell’s
diagnosis suffers given that it was made over one year after the onset of petitioner’s
symptoms. The Court of Federal Claims has explained that the added weight often
afforded treating physician opinions is due at least in part to their ability to observe the
unfolding of the condition at issue. Nuttall v. Sec’y of Health & Human Servs., 122 Fed.
Cl. 821, 832-33 (2015) (explaining that the Federal Circuit “found that a treating
physician who was familiar with the patient both before and after the alleged vaccine
injury is likely to be in a better position than an expert retained after the fact” to opine
with respect to vaccine causation), aff’d 640 Fed. Appx. 996 (Mem.) (Fed. Cir. 2016).
Here, as noted by Dr. Bouffard, without an examination close in time to the onset of
symptoms, “the expected course of optic neuritis could not be objectively confirmed.”
(Ex. A, p. 9.)
Instead, Dr. Thurtell expressed that he suspected an optic neuritis attack “[b]ased
on the history” rather than specifically citing objective findings. (Ex. 3, p. 14.) In fact, he
noted that his neuro-ophthalmic evaluation supported only mild optic neuropathy. (Id.)
However, the history petitioner provided to Dr. Thurtell was inconsistent with the history
he provided to Dr. Larson several months earlier. (Compare Ex. 1, p. 1 (reporting vision
loss over the course of one month to Dr. Larson), with Ex. 3, p. 9 (describing
progressive vision loss over the course of “days”). Further, Dr. Bouffard noted that Dr.
Thurtell did not record a detailed history for head trauma or call for a work-up to rule out
other causes for petitioner’s symptoms. (Ex. A, pp. 7, 9.) Finally, petitioner declined the
neuroimaging Dr. Thurtell recommended to help confirm the cause of petitioner’s
symptoms. (Id.) Therefore, Dr. Thurtell’s diagnostic opinion based on the history
provided by petitioner cannot overcome the dearth of objective findings or testing to
support the optic neuritis diagnosis. See Davis v. Sec’y of Health & Human Servs., 20
Cl. Ct. 168, 173 (1990) (stating that a treating physician’s conclusions “are only as good
as the reasons and evidence that support them”).
Accordingly, for the reasons discussed above, petitioner has not preponderately
established that he suffered optic neuritis.
VI. Conclusion
In light of the above, the evidence preponderates against a finding that petitioner
suffered optic neuritis. However, petitioner specifically pled optic neuritis in his petition.
(ECF No. 1.) Moreover, Dr. Steinman’s causal opinion is based on optic neuritis. (See,
e.g., Ex. 8, p. 7.) Accordingly, this fact finding is fatal to petitioner’s case as it is
currently framed.
21
A separate scheduling order will issue giving petitioner an opportunity to indicate
whether he intends to file an amended petition and supplemental expert report based on
an injury other than optic neuritis. However, if petitioner concludes that he cannot
reasonably file an amended petition or expert report, I will issue a decision dismissing
the case based on the existing record.
Given the rulings in section V.a granting in part and denying in part petitioner’s
motion to strike and denying respondent’s cross-motion to strike, the Clerk’s Office is
directed to strike the filings contained in ECF No. 96 from the record.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
22