VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-01283
Package ID: USCOURTS-cofc-1_15-vv-01283
Petitioner: Anna Hitt
Filed: 2015-10-29
Decided: 2021-08-13
Vaccine: influenza
Vaccination date: 2014-10-23
Condition: transverse myelitis and multiple sclerosis
Outcome: compensated
Award amount USD: 469237

AI-assisted case summary:
Anna Hitt, then 28 years old, filed a petition on October 29, 2015, alleging that an influenza vaccine administered on October 23, 2014, caused her to develop transverse myelitis and subsequently multiple sclerosis (MS). The Secretary of Health and Human Services opposed compensation, primarily arguing that Ms. Hitt had pre-existing symptoms of MS before the vaccination. Special Master Christian J. Moran presided over the case. The public decision does not name petitioner counsel or respondent counsel. 

Ms. Hitt, an athletic individual, had a history of knee pain and lumbar strain treated with physical therapy. In May and June 2013, she experienced numbness, coolness, and tenderness in her right leg, assessed as right leg/hip paresthesia, which resolved without intervention. In September 2013, she received physical therapy for a lumbar strain, reporting no numbness. In early October 2014, she reported low back pain from weight lifting, with no neurological symptoms noted, though she had mild bilateral toe weakness. On October 23, 2014, Ms. Hitt received the influenza vaccine. 

Within days, on October 26, 2014, she began experiencing progressive numbness in both legs. MRIs of her spine on October 30 and 31, 2014, revealed multiple lesions consistent with a demyelinating process. A subsequent MRI of her brain on November 20, 2014, showed lesions with enhancement, consistent with demyelinating disease. Her neurologist, Dr. April Erwin, diagnosed probable new-onset MS on November 20, 2014, noting the event appeared precipitated by the influenza vaccination. A lumbar puncture revealed five oligoclonal bands. On December 8, 2014, Dr. Erwin provided a definitive MS diagnosis by McDonald criteria using MRI and CSF data. 

During the entitlement phase, the parties presented expert testimony. Petitioner's expert, Dr. Carlo Tornatore, opined that the vaccination resulted in transverse myelitis, which can be the presenting entity of MS, and that the flu vaccine can cause transverse myelitis or MS. Respondent's expert, Dr. Peter Donofrio, argued that Ms. Hitt had MS symptoms before vaccination and that the flu vaccine does not cause MS. However, Dr. Donofrio conceded that if Ms. Hitt had no pre-vaccination neurological symptoms, the medical theories connecting the flu vaccine to transverse myelitis or MS were valid. Special Master Moran found that the evidence preponderated in favor of Ms. Hitt, concluding that her pre-vaccination symptoms were not related to a demyelinating disease and that the flu vaccine could cause her condition. He determined there was a logical sequence of cause and effect and a proximate temporal relationship between the vaccination and her symptoms, finding her entitled to compensation. 

The case proceeded to damages. Ms. Hitt, born in 1986, was 35 years old at the time of the damages decision and had a life expectancy of 48.4 years. Her MS has caused her little physical pain, but significant emotional distress due to the chronic nature of the disease, the fear of relapse, and the side effects of treatment, including Hashimoto's thyroiditis. The Special Master awarded $469,237.53. This included $79,064.95 for lost earnings (agreed upon by parties after tax reduction), $14,529.28 for past unreimbursed medical expenses (as testified by Ms. Hitt), and $125,643.30 as the present value of future unreimbursed medical expenses (based on $3,500 annual expenses and $85 annual mileage, reduced to present value). For pain, suffering, and emotional distress, the award was capped at $250,000. This comprised $5,000 for actual pain, $175,000 for suffering and emotional distress related to the chronic diagnosis of MS and Hashimoto's thyroiditis, and $30,000 for emotional distress from specific events like a seizure and treatment side effects. An additional $87,617.36 was awarded for projected pain, suffering, and emotional distress, calculated at $2,500 annually and reduced to present value, though this amount was subsumed within the $250,000 statutory cap.

Theory of causation field:
Anna Hitt, age 28, received an influenza vaccine on October 23, 2014. Within days, she developed progressive numbness in her legs, diagnosed as transverse myelitis and later multiple sclerosis (MS). Petitioner's expert, Dr. Carlo Tornatore, opined that the flu vaccine caused transverse myelitis, which can be the initial presentation of MS, and that the vaccine can trigger an immune response leading to MS. Respondent's expert, Dr. Peter Donofrio, initially argued Ms. Hitt had pre-existing MS symptoms and that the flu vaccine does not cause MS. However, Dr. Donofrio conceded that if Ms. Hitt had no pre-vaccination neurological symptoms, the medical theories linking the flu vaccine to transverse myelitis or MS were valid. Special Master Christian J. Moran found that Ms. Hitt did not have pre-vaccination demyelinating disease and that the flu vaccine could cause her condition, establishing a logical sequence of cause and effect and a proximate temporal relationship. The case was determined to be 'Off-Table.' Ms. Hitt was awarded $469,237.53, including $250,000 for pain, suffering, and emotional distress (capped), $93,594.23 for past expenses (lost earnings and medical), and $125,643.30 for future medical expenses (present value). Attorneys for petitioner were Clifford J. Shoemaker and Renee Gentry; attorney for respondent was Jason C. Bougere. The entitlement ruling was issued January 24, 2020, and the damages decision on August 13, 2021.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-01283-0
Date issued/filed: 2020-02-20
Pages: 17
Docket text: PUBLIC ORDER/RULING (Originally filed: 1/24/2020) regarding 102 Ruling on Entitlement. Signed by Special Master Christian J. Moran. (abs) Service on parties made.
--------------------------------------------------------------------------------
Case 1:15-vv-01283-UNJ Document 105 Filed 02/20/20 Page 1 of 17
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
ANNA HITT, *
* No. 15-1283V
Petitioner, * Special Master Christian J. Moran
*
v. * Filed: January 24, 2020
*
SECRETARY OF HEALTH * Entitlement, influenza (“flu”) vaccine,
AND HUMAN SERVICES, * multiple sclerosis, transverse myelitis
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Clifford J. Shoemaker, Shoemaker, Gentry, & Knickelbein, Vienna, VA, and
Renee Gentry, Washington, DC, for petitioner;
Jason C. Bougere, United States Dep’t of Justice, Washington, DC, for respondent.
PUBLISHED RULING ON ENTITLEMENT1
Anna Hitt filed a petition under the National Childhood Vaccine Injury Act,
42 U.S.C. § 300aa-10 through 34 (2012) on October 29, 2015. Her petition alleged
that she received the influenza (“flu”) vaccine on October 23, 2014, which caused
her to develop transverse myelitis and, ultimately, multiple sclerosis.2
The Secretary primarily opposed compensation on the grounds that Ms. Hitt
experienced multiple sclerosis symptoms prior to her flu vaccination. During an
entitlement hearing, the Secretary’s expert effectively conceded that the flu vaccine
can cause either transverse myelitis or multiple sclerosis. Because the evidence
1 The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), requires that the Court post this decision on its
website (http://www.cofc.uscourts.gov/aggregator/sources/7). Pursuant to Vaccine Rule 18(b),
the parties have 14 days to file a motion proposing redaction of medical information or other
information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special
master will appear in the document posted on the website.
2 Transverse myelitis is abbreviated as “TM” and multiple sclerosis to “MS.”

Case 1:15-vv-01283-UNJ Document 105 Filed 02/20/20 Page 2 of 17
does not support a finding that Ms. Hitt’s pre-vaccination symptoms were related
to her multiple sclerosis, Ms. Hitt is entitled to compensation.
I. Facts
Here, the parties largely (if not entirely) agree about the relevant events in
Ms. Hitt’s medical history. Consequently, the facts are presented summarily,
although a more detailed recitation can be found in the parties’ briefs. See Pet’r’s
Preh’g Br., filed Feb. 14, 2018, at 2-9; Resp’t’s Preh’g Br., filed Mar. 16, 2018, at
2-7.
Ms. Hitt competed in Division I college athletics. She describes herself as
“very active and athletic.” Exhibit 14 at 1 (Ms. Hitt’s affidavit). A physical
therapist similarly noted that Ms. Hitt was a “very fit young lady with [an] athletic
background.” Exhibit 8 at 10. After college, Ms. Hitt trained adults and children
at a gym. Tr. 13. In August 2012, she received physical therapy treatment for
right knee pain that had gradually arisen from “athletics/running.” Exhibit 2 at 44-
47.
At age 26, during a series of appointments in May and June 2013, Ms. Hitt
reported having numbness, coolness, and tenderness in her right leg, extending into
the toes of her right foot. Exhibit 1 at 5-9. Her doctor, Jeffrey Burnham, reached
the impression that she suffered from “right leg / hip paresthesia / lumbar.” Id. at
5. At a later appointment in that series, Ms. Hitt reported that she had less
numbness, and the record contains no mention of coolness. Id. It appears that the
problem dissipated without any medical intervention because Ms. Hitt felt well
enough to join a gym in August 2013 to begin a consistent weight lighting routine
for the first time since graduating from college in 2009. Exhibit 14 at 1. Prior to
joining the gym, Ms. Hitt had stayed active by running and occasionally lifting
weights. Tr. 17.
In September 2013, Ms. Hitt sought physical therapy treatment for a lower
back injury, a lumbar strain, from lifting weights. Exhibit 2 at 17, 38. In the initial
assessment of Ms. Hitt’s physical impairments, the physical therapist identified
flexibility, pain, range of motion, weakness, and soft tissue mobility. Id. at 11-13.
Ms. Hitt appears not to have complained of numbness during this round of physical
therapy. In October 2013, following overall improvement in her condition, Ms.
Hitt was then discharged from physical therapy to pursue an independent home
exercise program. Id. at 2-3, 5; see exhibit 8 at 10 (Ms. Hitt reported that lumbar
strain in 2013 resolved with self-treatment).
2

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More than one year later, on October 13, 2014, Ms. Hitt reported low back
pain from weight lifting a week and a half earlier (approximately October 2, 2014)
to Chambliss Harrod, a doctor at the Bone and Joint Clinic. Dr. Harrod described
Ms. Hitt’s pain as getting better but then worsening due to Ms. Hitt’s continued,
though somewhat restricted, weight lifting. Dr. Harrod noted “no numbness,
tingling or weakness,” “no neurological symptoms,” and bilateral toe weakness of
4+/5 with Ms. Hitt being “slightly guarded from pain.” Exhibit 9 at 52-53. From
Dr. Harrod’s order, Ms. Hitt saw a physical therapist to whom she again described
her low back pain but noted that the pain did not have a radicular (nerve)
component. Exhibit 8 at 10-11; see also exhibit 14.
As part of her participation in a nursing program, Ms. Hitt received the flu
vaccine on October 23, 2014. Exhibit 13 at 2. Ms. Hitt alleges that the flu vaccine
caused her subsequent neurologic problems. See Pet.
On October 29, 2014, Ms. Hitt told her physical therapist that she was
having progressive numbness in both legs. She further recounted that the
numbness started the previous Saturday, October 26, 2014. Exhibit 8 at 5-8. The
physical therapist, in turn, communicated with Dr. Chambliss. Exhibit 9 at 31.
Later on October 29, 2014, Dr. Chambliss created a note stating that Ms. Hitt had
called his office and that she needs an MRI as soon as possible. Exhibit 9 at 36.3
On October 30, 2014, Ms. Hitt had an MRI of her lumbar spine without
contrast performed. The radiologist was Robert Miller. Dr. Miller found “a 6mm
nodular focus of T2 hyperintensity . . . within the distal cord, at the level of the
T11-12 disc.” With this information, Dr. Miller stated that “The patient will be
contacted to return for additional inversion recovery sequences, to include the
entire cord, followed by postcontrast imaging.” Exhibit 9 at 33.
The next day, October 31, 2014, Ms. Hitt returned for additional MRIs with
and without contrast. Exhibit 14 ¶ 4. The radiologist was David Hoff. For the
cervical spine, Dr. Hoff identified “patchy areas of abnormal signal in the cord
with expansion of the cord and edema of the cord identified at the C2, C3-C4, C5-
C6, and T2 levels. Multiple patchy foci of abnormal signal in the cord are
3 Dr. Chambliss is an orthopedist and the form he uses to order MRIs has boxes for the
doctor to identify various body parts, such as “Wrist R or L” and “Pelvis.” The MRI order form
includes “cervical,” “thoracic,” and “lumbar.” The form does not include “brain.” Exhibit 9 at
15.
3

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suspicious for multiple sclerosis.” Exhibit 9 at 24. Following the injection of
contrast, Dr. Hoff did not see any “significant enhancements.” Id. In addition to
stating that the appearance was “suspicious for multiple sclerosis,” Dr. Hoff
included transverse myelitis within the differential. Id.
The results for the thoracic spine were similar. Dr. Hoff stated: “Patchy
abnormal signal in the cord can be seen at the T2 level possibly at the T6-T7 levels
at the T10 level and at the T11-T12 levels.” Id. at 25. Again, following the
injection of contrast, Dr. Hoff did not see any “significant enhancements.” Id. He
interpreted these findings as “represent[ing] a demyelinating process and likely this
represents multiple sclerosis.” Id.4
Ms. Hitt recounted that she did not immediately hear from her doctor,
although she was worried about the outcome of the MRIs. But, later in the
evening, after she had gone to bed, the doctor called to come over to her residence.
At her residence, the doctor told Ms. Hitt that she had multiple sclerosis. To
address this issue, Ms. Hitt had an appointment with a neurologist for the following
Monday. Exhibit 14 ¶ 5.
The first appointment with April Erwin, the neurologist who has treated Ms.
Hitt, took place on November 3, 2014. Ms. Hitt informed Dr. Erwin that she had
received the flu vaccine four days before the onset of symptoms. Exhibit 11 at 28.
Dr. Erwin indicated that “this may be a vaccine-related event” and she provided
information about the National Vaccine Injury Compensation Fund. Id. at 32. Dr.
Erwin reviewed the MRIs of Ms. Hitt’s spine and determined that Ms. Hitt should
have an MRI of her brain. Dr. Erwin commented: “We may be able to establish an
MS diagnosis without [a lumbar puncture] if she has old-appearing demyelinating
lesions in the brain, to go along with the new-appearing lesions in the spinal cord.”
Id. Dr. Erwin also ordered a three-day course of intravenous methylprednisolone
and requested that Ms. Hitt return in two to three weeks to discuss the results. Id.
The date of the brain MRI was November 20, 2014, which was nearly one
month after Ms. Hitt first had symptoms of numbness on October 26, 2014. At the
beginning of the MRI report, it states: “History: Question multiple sclerosis.” The
interpreting radiologist, Richard W. Foster, identified several “areas of altered T2
signal along with periventricular areas of altered T2 signals.” “At least one lesion
4 Dr. Hoff, in a different portion of this report, stated the finding “represents a
demyelinating process possibly multiple sclerosis.” Exhibit 9 at 25.
4

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shows enhancement following contrast.” Dr. Foster stated that the findings were
“consistent with demyelinating disease,” although Dr. Foster did not specify
multiple sclerosis, transverse myelitis, or any other condition. Exhibit 11 at 26.
The follow-up appointment with Dr. Erwin occurred on the same day as the
brain MRI. Dr. Erwin’s history stated that “despite the initial 3-day course of
SoluMedrol,” Ms. Hitt reported “some upward spread of numbness on the
abdomen/torso.” Exhibit 11 at 20. Dr. Erwin recounted that Ms. Hitt “had no prior
neurologic symptoms or events until receiving her mandatory influenza vaccine for
her work as an ICU nurse. She developed symptoms of transverse myelitis within
4 days of the vaccine, with no other risks factors noted.” Id.
Dr. Erwin reviewed Ms. Hitt’s systems, conducted a physical examination,
and reviewed the results of the brain MRI. Dr. Erwin stated that Ms. Hitt “has
demyelinating lesions in both the brain and the spinal cord, indicating probable
new onset MS.” Dr. Erwin continued: “This fulminant demyelinating event
appears to have been precipitated by influenza vaccination 4 days prior to
symptom onset, as no other precipitating factor has been noted.” Dr. Erwin
ordered another three-day course of SoluMedrol and a lumbar puncture.
Ms. Hitt underwent a lumbar puncture on November 24, 2014. Exhibit 10 at
19. The results showed that she had five oligoclonal bands. Id. at 27.
For purposes of determining whether the flu vaccination harmed Ms. Hitt,
the most recent critical event was the December 8, 2014 appointment with Dr.
Erwin. Dr. Erwin stated that Ms. Hitt had a “definitive MS diagnosis . . . by
McDonald criteria using MRI and CSF data.” Exhibit 11 at 14. Dr. Erwin also
advised Ms. Hitt “not to have influenza vaccination in the future due to
complication of demyelination.” Id.
After December 2014, the remainder of Ms. Hitt’s medical records show
how she fared with multiple sclerosis. Ms. Hitt, a trained nurse, expressed
gratitude that, although she suffers from “profound numbness, loss of coordination,
muscle spasticity and extreme pain, difficulty concentrating, and loss of strength,”
her symptoms “are mild compared to some reported by others who have been
5

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diagnosed with MS.” Exhibit 14 ¶ 8.5 Ms. Hitt fears that a multiple sclerosis flare
may take away her ability to walk. Tr. 37.
II. Procedural History
Ms. Hitt claimed that following the flu vaccine, testing confirmed that she
had transverse myelitis and was later diagnosed with multiple sclerosis. Pet., filed
Oct. 29, 2015, at 2 ¶ 8. The petition seeks compensation for Ms. Hitt’s “losses.”
Pet. ¶ 10.
The Secretary filed a report, pursuant to Vaccine Rule 4, stating that Ms.
Hitt’s claim was not appropriate for compensation. Resp’t’s Rep. at 2. The
Secretary argued that Ms. Hitt had not offered a substantive medical theory
causally connecting the flu vaccine to transverse myelitis or multiple sclerosis. Id.
at 6.
Ms. Hitt stated her intent to obtain a report from an expert. To facilitate this
process, the undersigned proposed expert instructions and allowed time for the
parties to comment on them. After the parties did not comment on the proposed
expert instructions, they became final on April 20, 2016.
Ms. Hitt filed her first report from Dr. Carlo Tornatore on October 24, 2016.
Exhibit 17. Dr. Tornatore is a neurologist and has testified in many Vaccine
Program cases. Dr. Tornatore has directed the Georgetown University Hospital
Multiple Sclerosis Clinic since 2000. Exhibit 68 (updated curriculum vitae). He
follows thousands of patients with multiple sclerosis.
Dr. Tornatore’s first report did not present a complete case. Although Dr.
Tornatore cited Dr. Erwin’s November 20, 2014 report in which Dr. Erwin
diagnosed Ms. Hitt with “‘probable new onset MS,’” exhibit 17 at 2, quoting
exhibit 11 at 24, Dr. Tornatore otherwise barely mentioned multiple sclerosis.
Instead, Dr. Tornatore opined that the vaccination “resulted in transverse myelitis.”
Exhibit 17 at 6. He explained how, in his opinion, a vaccination can cause
transverse myelitis.
The Secretary filed a responsive report from Dr. Peter Donofrio on April 10,
2017. Exhibit A. Dr. Donofrio is also a neurologist. Exhibit B (curriculum vitae).
5 Although this decision does not recount all the medical records, the undersigned has
reviewed them all.
6

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Although Dr. Donofrio has treated hundreds of patients with multiple sclerosis, but
he does not specialize in treating patients with multiple sclerosis. Exhibit A at 1.
In his report, Dr. Donofrio raises three important arguments. First, he
maintained that Ms. Hitt did not suffer from transverse myelitis. Instead, she
suffered from multiple sclerosis. Exhibit A at 5-7. Second, Dr. Donofrio
maintained that the onset of the multiple sclerosis was before the vaccination. Id.
at 7. Third, Dr. Donofrio briefly asserts that the medical literature does not support
a finding that the flu vaccination can cause multiple sclerosis. Id.
Both experts were directed to clarify issues from their initial reports. Dr.
Tornatore was ordered to address Ms. Hitt’s multiple sclerosis diagnosis, to state
whether he maintains the transverse myelitis diagnosis, and to comment on Dr.
Donofrio’s report. Order, issued Apr. 27, 2017, at 1-3. Dr. Donofrio was also
ordered to address Dr. Tornatore’s main argument that the flu vaccine can cause
transverse myelitis. Id. at 3-4. Shortly after this order was issued, an entitlement
hearing was scheduled for April 17, 2018.
Ms. Hitt filed a second report from Dr. Tornatore on May 31, 2017. Exhibit
36. Dr. Tornatore asserted that “transverse myelitis[] can be the presenting entity
in someone who is subsequently diagnosed with Multiple Sclerosis.” Id. at 6. He
continued to maintain that the flu vaccine can cause transverse myelitis. He also
combined these two assertions, reasoning “given that transverse myelitis can be the
first presentation of Multiple Sclerosis, it follows that a vaccine can trigger an
immune response that ultimately can result in Multiple Sclerosis.” Id. at 12.
The Secretary filed a second report from Dr. Donofrio on May 31, 2017.
Exhibit C. Dr. Donofrio reiterated his view that Ms. Hitt did not meet the
diagnostic criteria for transverse myelitis but did meet the criteria for multiple
sclerosis. Id. at 1. Because he did not believe that Ms. Hitt can be diagnosed with
transverse myelitis, Dr. Donofrio declined to address whether the flu vaccine can
cause transverse myelitis. Id. at 4.
The undersigned issued an order for pre-hearing briefs on October 25, 2017.
The parties were ordered to address whether transverse myelitis was the proper
diagnosis of Ms. Hitt before her ultimate diagnosis of multiple sclerosis. Order,
issued Oct. 25, 2017, at 4. The parties were also ordered to address the differing
diagnostic criteria proposed by each side. Id.
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Ms. Hitt filed her pre-hearing brief and additional medical literature on
February 14, 2018. The Secretary filed his pre-hearing brief and additional
medical literature on March 16, 2018.
After reviewing the parties’ submissions, the undersigned conducted three
pre-trial conferences. In the first pre-trial conference, the undersigned noted that
Dr. Tornatore had not addressed the factors that exclude a diagnosis of transverse
myelitis, notably the MRIs from October 2014. In the second pre-trial conference,
Ms. Hitt’s attorney made numerous statements about what the record showed but
ultimately requested the opportunity to file another supplemental report from Dr.
Tornatore within five days. Ms. Hitt was ordered to file a supplemental report
from Dr. Tornatore promptly. Order, issued Apr. 5, 2018. Ms. Hitt punctually
filed a third report from Dr. Tornatore. Exhibit 67.
In his third report, Dr. Tornatore stated that Ms. Hitt’s symptoms beginning
on October 26, 2014, “were solely due to spinal cord inflammation aka partial
transverse myelitis.” Id. at 2. He stated that because a cranial MRI was not done
at the same time as the spinal MRIs, “the diagnosis of [multiple sclerosis] cannot
be made or established for that point.” Id. Later, Dr. Tornatore repeated and
extended this point. He stated: “Neither the TM diagnostic criteria [n]or the
McDonald criteria were developed to extend diagnoses to a prior period of time.”
Id. at 3.
After Ms. Hitt filed Dr. Tornatore’s third report, the undersigned decided to
proceed with the hearing. A final pre-trial conference to discuss logistics was held
on April 12, 2018. The hearing took place on April 17, 2018. Because Dr.
Tornatore’s and Dr. Donofrio’s reports constituted their direct testimony, the oral
direct testimony was relatively short. Most of the hearing time was spent on
answering either questions from the undersigned or questions on cross-
examination.
Following the hearing, the undersigned proposed that the parties explore an
informal resolution based upon the costs and risks of continued litigation. The
parties attempted to reach a settlement. However, they were not successful.
After the parties reported an impasse in settlement discussion, further
briefing was ordered. See order, issued Sept. 11, 2018. Ms. Hitt filed an initial
brief, the Secretary filed a responsive brief, and Ms. Hitt filed a reply brief. This
matter is now ready for adjudication.
8

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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 & Human 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 &
Human 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 & Human 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 & Human Servs., 219
F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec'y of Health & Human 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).
Ms. Hitt’s injury claim is not included in the Vaccine Injury Table so she
must establish that the flu vaccine did in fact cause her injury. 42 U.S.C.A. §
300aa-11(c)(1)(C)(i)-(ii). Ms. Hitt must establish, by a preponderance of the
evidence, the elements set forth in Althen v. Sec’y of Health and Human Servs.,
418 F.3d 1274, 1278 (Fed. Cir. 2005).
IV. Analysis
The Secretary’s objections to diagnosis and the prongs set forth in Althen,
418 F.3d at 1278, are rooted in his assertion that Ms. Hitt likely already had
multiple sclerosis before she received the flu vaccination. Therefore, whether Ms.
Hitt had multiple sclerosis before the vaccination will be addressed first.
A. Onset of Ms. Hitt’s Demyelinating Disease
The critical factual question is whether Ms. Hitt suffered a demyelinating
disease before her vaccination. If Ms. Hitt did have a demyelinating disease before
vaccination, then she cannot establish that the vaccination caused the disease.
Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1380-81 (Fed. Cir.
2012) (ruling that if the vaccinee suffers from a disease before the vaccination,
then an Althen-analysis is not required). Multiple sclerosis, for example, has been
9

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found to afflict a vaccinee before vaccination, defeating a causation-in-fact claim.
E.g. Heddens v. Sec’y of Health & Human Servs., 143 Fed. Cl. 193, 196 (2019).
While the basic definition of multiple sclerosis has not changed, the
diagnostic criteria for practitioners have been revised periodically. The 2010
diagnostic criteria recognized that earlier episodes can constitute a previous
demyelinating event. “Although a new attack should be documented by
contemporaneous neurological examination, in the appropriate context, some
historical events with symptoms and evolution characteristic for MS, but for which
no objective neurological findings are documented, can provide reasonable
evidence of a prior demyelinating event.” Exhibit A-1 (Polman et al., Diagnostic
Criteria for Multiple Sclerosis: 2010 Revisions to the McDonald Criteria, 69 Ann.
Neurol. 292 (2011)) at 293 (emphasis added). The 2017 diagnostic criteria
explained “typical presentations” of multiple sclerosis include “unilateral optic
neuritis, focal supratentorial syndrome, focal brainstem or cerebellar syndrome or
partial myelopathy.” Exhibit D (Alan J. Thompson et al., Diagnosis of multiple
sclerosis: 2017 revisions of the McDonald criteria, 17 Lancet Neurology 162
(2018)) at 163.
Here, in their analysis of Ms. Hitt’s medical records, the experts focus on
four data points. These are Ms. Hitt’s symptoms in May-June 2013; Ms. Hitt’s
symptoms in early October 2014; the results of Ms. Hitt’s spinal MRIs on October
30-31, 2014; and the result of Ms. Hitt’s brain MRI. For Ms. Hitt, Dr. Tornatore
opined that all her pre-vaccination symptoms were not related to a demyelinating
disease and that the symptoms reported on October 29, 2014, were Ms. Hitt’s first
neurologic symptoms related to a demyelinating disease. Tr. 91-92; 179-82. In
contrast, for the Secretary, Dr. Donofrio argued that Ms. Hitt’s symptoms reported
at the June 3, 2013 appointment were her first multiple sclerosis attack, the
symptoms reported at her October 13, 2014 appointment were her second attack,
and the symptoms reported at her (first post-vaccination) appointment on October
29, 2014, were her third attack. Exhibit C at 2-3; Tr. 143.
1. Symptoms in May-June 2013.
At her June 3, 2013 appointment, Ms. Hitt reported having numbness,
coolness, and tenderness in her right leg, extending into the toes of her right foot.
Exhibit 1 at 6. Dr. Burnham assessed her as suffering from right “leg paresthesia.”
Id. at 5. In a follow-up appointment, Ms. Hitt reported that she had less numbness
and there is no mention of coolness. Id. at 5. Dr. Burnham assessed Ms. Hitt as
right “leg / hip paresthesias / lumbar.” Id.
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In interpreting Dr. Burnham’s records, Dr. Tornatore stated that Ms. Hitt’s
symptoms reported at the June 3, 2013 appointment did not last long enough nor
were they “profound” enough to qualify as a multiple sclerosis attack under the
multiple sclerosis diagnostic criteria. Tr. 88-89. Dr. Tornatore also maintained
that these symptoms were musculoskeletal in nature and not even neurologic. Tr.
91-92; see also Tr. 178-79. In opposition, Dr. Donofrio opined that the leg/hip
paresthesia, as well as the coolness, were neurological symptoms and concluded
that the symptoms signified Ms. Hitt’s first episode of multiple sclerosis. Exhibit
C at 2-3; Tr. 147.
While the evidence on this point is relatively close, the stronger evidence
favors Ms. Hitt’s position. First, Dr. Tornatore, unlike Dr. Donofrio, specializes in
treating patients with multiple sclerosis. His expertise in this field merits some
additional weight. See Depena v. Sec'y of Health & Human Servs., No. 13-675V,
2017 WL 1075101, at *7 (Fed. Cl. Spec. Mstr. Feb. 22, 2017), mot. for rev. denied,
133 Fed. Cl. 535, 547-48 (2017), aff'd without op., 730 Fed. App'x 938 (Fed. Cir.
2018); Copenhaver v. Sec'y of Health & Human Servs., No. 13-1002V, 2016 WL
3456436, at *7 (Fed. Cl. Spec. Mstr. May 31, 2016), mot. for rev. denied, 129 Fed.
Cl. 176 (2016). Second, as Dr. Donofrio recognized, Dr. Burnham did not conduct
a neurologic examination, such as testing reflexes. Tr. 147. In Dr. Donofrio’s
view, Dr. Burnham’s work “would not have been a neurologic examination that
would be adequate enough to come to a conclusion.” Tr. 148. Thus, the evidence
preponderates in favor of finding that the June 2013 episodes were not
demyelinating.
2. Symptoms in early October 2014.
The other symptom Dr. Donofrio identified as an undiagnosed manifestation
of multiple sclerosis came in October 2014. At Ms. Hitt’s October 13, 2014
appointment, she reported low back pain from weight lifting a week and a half
earlier (approximately October 2, 2014) to Chambliss Harrod. Dr. Harrod
described Ms. Hitt’s pain as getting better but then worsening due to Ms. Hitt’s
continued, though somewhat restricted, weight lifting. Dr. Harrod noted “no
numbness, tingling or weakness,” “no neurological symptoms,” and bilateral toe
weakness of 4+/5 with Ms. Hitt being “slightly guarded from pain.” Exhibit 9 at
52-53. From Dr. Harrod’s order, Ms. Hitt saw a physical therapist to whom she
again described her low back pain, noting that the pain did not have a radicular
(nerve) component. Exhibit 8 at 10-11; see also exhibit 14.
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From this group of complaints, Dr. Donofrio isolated Ms. Hitt’s “mild
weakness of toe extension” as an indicator of a multiple sclerosis attack. Dr.
Donofrio qualified his opinion in several respects. Dr. Donofrio admitted that the
weakness may not show a neurologic problem and “there may not be a specific
neurologic problem.” Tr. 151-53. Dr. Donofrio recognized that Ms. Hitt’s being
“slightly guarded from pain” during the examination may have affected her toe
weakness score. Tr. 151. Dr. Donofrio categorized Ms. Hitt’s toe weakness as
“atypical” and “unexpected.” Id. 152.
Dr. Tornatore agreed that Ms. Hitt’s guardedness from pain she was
experiencing during the examination may have resulted in her mild toe weakness
score. Tr. 180-81. Dr. Tornatore also argued that the toe weakness, and other
symptoms, were not neurologic in nature because Ms. Hitt’s toe strength returned
to normal and her lumbar pain improved. Tr. 181-82 (discussing October 29, 2014
and November 3, 2014 appointments). The undersigned finds Dr. Tornatore’s
argument persuasive that Ms. Hitt’s symptoms at the beginning of October 2014
were not neurologic and do not support a multiple sclerosis attack at that time.
3. Spinal MRIs.
Both experts agree that Ms. Hitt experienced a demyelinating episode on
October 26, 2014. See exhibit 36 at 12, exhibit C at 3. The experts disagree on
whether the MRIs taken soon after that episode show that Ms. Hitt was
experiencing demyelination before the vaccination. The October 30, 2014 MRI of
Ms. Hitt’s lumbar spine revealed one lesion at the T11-12 disc. Exhibit 9 at 33.
On October 31, 2014, Ms. Hitt had MRIs on her cervical and thoracic spine.
Exhibit 9 at 24-25.6 For both the cervical and thoracic spine, the interpreting
radiologist, Dr. Hoff, found “Multiple patchy foci of abnormal signal.” Id.7
6 It appears that the results from the October 31, 2014 cervical spine MRI also appear at
page 26.
7 While the October 30 and 31, 2014 MRIs did not show any enhancement, Tr. 100, Dr.
Donofrio has not offered any opinion that the lack of enhancement means that the lesions were
sufficiently aged that the lesions must have pre-dated the vaccination. See exhibit A, exhibit C.
Thus, Ms. Hitt’s case is distinguishable from W.C. v. Sec’y of Health & Human Servs., No. 07-
456V, 2011 WL 4537877, at *8 (Fed. Cl. Spec. Mstr. Feb. 22, 2011), mot. for rev. denied in
relevant part, 100 Fed. Cl. 440, 451-53 (2011), aff’d, 704 F.3d 1352 (Fed. Cir. 2013); and Frantz
v. Sec’y of Health & Human Servs., No. 13-158V, 2019 WL 3713942, at *17 (Fed. Cl. Spec.
12

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In support of his overall opinion that Ms. Hitt suffered demyelination before
the vaccination, Dr. Donofrio asserted that the “seven” lesions on Ms. Hitt’s spine
shown on the October 30 and 31, 2014 MRIs were “unusual.” This “unusual”
number, in turn, suggested that some of the lesions existed before the October 23,
2014 vaccination. Tr. 134.
While Dr. Tornatore agreed with the presence of seven lesions, he explained
that the MRIs showed “edema,” meaning inflammation. In his view, the edema
suggested that the lesions were new and did not exist before the vaccination. Tr.
174-75. Dr. Tornatore added that for an initial demyelinating episode, a higher
number of lesions all appearing together may occur and that Dr. Donofrio had not
cited any literature to the contrary. Id. The diagnostic criteria for multiple
sclerosis only list the minimum number of lesions needed to diagnose multiple
sclerosis in different circumstances, not a maximum. Exhibit D (Thompson) at
167 / pdf 6 (Table).
4. Brain MRI.
Perhaps due to insurance company restrictions, see Tr. 44, 158; Ms. Hitt’s
brain MRI was performed on November 20, 2014, which was approximately one
month after she first reported symptoms. This MRI showed lesions in her brain
with enhancement in at least one lesion. Exhibit 11 at 26. Dr. Tornatore argued
that brain MRIs allow predictions about future developments but that a brain MRI
could only let you look backwards a “couple weeks.” Tr. 66 Dr. Donofrio does
not make an argument that the brain MRI can indicate when Ms. Hitt began to
develop a demyelinating disease.
In sum, while Dr. Donofrio raised some good points, overall, Dr. Tornatore
was persuasive in explaining that Ms. Hitt likely did not suffer from demyelination
before the vaccination. Ms. Hitt first suffered a demyelinating episode on October
26, 2014.
As previously mentioned, Dr. Donofrio’s chief reason for asserting that the
vaccination did not cause Ms. Hitt’s demyelinating disease was his opinion that the
Mstr. June 24, 2019) (discussing black holes), mot. for rev. denied, 2019 WL 6974431 (Fed. Cl.
Nov. 13, 2019).
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disease pre-dated the vaccination. Therefore, the remaining elements of Ms. Hitt’s
case can be discussed relatively quickly because there is less meaningful
disagreement about the remainder of the case.
B. Diagnosis
In Broekelschen v. Sec’y of Health and Human Servs., 618 F.3d 1339, 1346
(Fed. Cir. 2010), the Federal Circuit recognized that in some circumstances, the
special master may “first determine which injury was best supported by the
evidence in the record before applying the Althen test.” Broekelschen’s
requirement that the petitioners establish, by preponderant evidence, that the
vaccinee suffer the condition for which compensation is claimed is not limited to
narrow circumstances. Stillwell v. Secʼy of Health & Human Servs., 118 Fed. Cl.
47, 56-58 (2014) (discussing Broekelschen and subsequent Federal Circuit cases),
aff’d without opinion, 607 F. App’x 997 (Fed. Cir. 2015).
Although Dr. Tornatore and Dr. Donofrio parried over the question of
diagnosis in their written reports, the experts ultimately agreed that Ms. Hitt
suffered from multiple sclerosis that initially presented as transverse myelitis.
Based on Ms. Hitt’s onset of symptoms on October 26, 2014, and the subsequent
spinal MRIs, Dr. Tornatore opined that Ms. Hitt initially developed transverse
myelitis. Exhibit 67 at 2. Dr. Tornatore stated that the lack of a cranial MRI at this
point made it impossible to diagnose multiple sclerosis. Id. On November 20,
2014, Ms. Hitt had a brain MRI. Based on the brain MRI findings, Dr. Tornatore
stated that Ms. Hitt’s multiple sclerosis diagnosis was established on November 20,
2014. Exhibit 67 at 3. In his oral testimony, Dr. Tornatore stated Ms. Hitt had
“transverse myelitis, which is disease-associated, and the disease it’s associated
with is multiple sclerosis.” Tr. 98.
Dr. Donofrio agreed with Dr. Tornatore that Ms. Hitt suffered from
“transverse myelitis associated with multiple sclerosis.” Tr. 142; accord Tr. 138.
In sum, the weight of the evidence supports transverse myelitis as Ms. Hitt’s initial
diagnosis and multiple sclerosis as a subsequent diagnosis.8
8 The importance of the diagnosis is diminished by Dr. Donofrio’s concession that the
medical theories presented by Dr. Tornatore describing how a flu vaccination could cause either
transverse myelitis or multiple sclerosis are valid. Thus, regardless of which diagnosis is
determined to be correct, either diagnosis would result in compensation for Ms. Hitt.
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C. Medical Theory
For Althen prong one, Ms. Hitt must establish a “reputable” medical theory
that the flu vaccination can cause her injury by a preponderance of the evidence
but does not need to prove that theory to the level of scientific certainty. Althen,
418 F.3d at 1278 (“A persuasive medical theory . . . being supported by reputable
medical or scientific explanation”) (internal citations omitted). In a later case, the
Federal Circuit required that the theory be “legally probable.” Moberly v. Sec'y of
Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010).
Dr. Tornatore presented medical theories connecting the flu vaccine to
transverse myelitis and multiple sclerosis. Exhibit 17 at 3-7; exhibit 36 at 12. Dr.
Tornatore supported his theories with medical literature.
As noted previously, Dr. Donofrio’s primary argument against causation was
that Ms. Hitt had multiple sclerosis before her vaccination. Tr. 161. While Dr.
Donofrio briefly disputed Dr. Tornatore’s medical theories in his expert reports,
exhibit A at 7 and exhibit C at 3-4, when presented with a hypothetical that Ms.
Hitt never had neurological symptoms pre-vaccination, Dr. Donofrio agreed that
the medical theories that flu vaccine could cause either transverse myelitis or
multiple sclerosis were “valid.” Tr. 166. When pressed further on cross-
examination, Dr. Donofrio stated that he agreed that the flu vaccine can cause
either transverse myelitis or multiple sclerosis.9 Id. This testimony weighs heavily
in petitioner’s favor.
Based upon these concessions, the experts basically agree that the flu
vaccine can cause a demyelinating condition. Thus, Ms. Hitt has carried her
burden in establishing a medical theory.10
9 In his post-hearing brief, the Secretary characterizes Dr. Tornatore’s medical theories as
“speculative” and “overly broad,” and references Dr. Donofrio’s expert reports. Resp’t’s Post-
H’rg Br. at 1, 7. As for Dr. Donofrio’s testimony regarding the hypothetical question of Ms. Hitt
not having any pre-vaccination neurological symptoms, the Secretary again falls back on the
position that Ms. Hitt had pre-vaccination multiple sclerosis episodes, thereby precluding
vaccine causation. Id. at 8-9.
10 Of course, in a case with different evidence, the outcome might differ. See Lampe v.
Sec'y of Health & Human Servs., 219 F.3d 1357, 1366 (Fed. Cir. 2000) (“a special master’s task
is to make a factual determination based on the evidence in a particular case.”).
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D. Logical Sequence of Cause and Effect
For Althen prong two, Ms. Hitt must establish a logical sequence of cause
and effect that the flu vaccination caused her injury. Althen, 418 F.3d at 1278.
Preliminarily, Ms. Hitt’s case meets the basic sequence of events in that she
received the vaccination and then manifested a disease.
While the vaccination must precede the onset of the disease for the
vaccination to have contributed to the disease, a simple sequence of events is not
sufficient. Other probative evidence may come from treating doctors. Capizzano
v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006).
Here, Ms. Hitt’s treating neurologist, Dr. Erwin, supports a finding of
causation. Dr. Erwin commented that “this fulminant demyelinating event appears
to have been precipitated by the influenza vaccination 4 days prior to symptom
onset, as no other precipitating factor had been noted.” Exhibit 11 at 24. At
another appointment, Dr. Erwin noted that Ms. Hitt had “no other risk factors”
related to demyelinating diseases. Id. at 20. Dr. Donofrio also characterized the
medical records as attributing Ms. Hitt’s demyelinating disease to the flu
vaccination. Exhibit A at 2. Thus, Ms. Hitt has carried her burden in establishing
a logical sequence of cause and effect that the flu vaccination caused her injury.
E. Timing
For Althen prong three, Ms. Hitt must establish a proximate temporal
relationship between the flu vaccination and her injury. Althen, 418 F.3d at 1278.
The timing prong actually contains two parts. A petitioner must show the
“timeframe for which it is medically acceptable to infer causation” and the onset of
the disease occurred in this period. Shapiro v. Secʼy of Health & Human Servs.,
101 Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other grounds,
105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).
Regarding the medically acceptable timeframe for inferring causation, Dr.
Tornatore proposed a range of 1 to 63 days. Exhibit 17 at 5, exhibit 36 at 11.
While not addressed in his reports, Dr. Donofrio seemed to generally accept Dr.
Tornatore’s timeframe. Tr. 160.
As for the actual onset of the disease, Ms. Hitt received the flu vaccine on
October 23, 2014, and experienced the onset of symptoms on October 26, 2014.
Exhibit 8 at 5-8. Neither party disputes that these symptoms occurred on that day.
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Again, the finding above that Ms. Hitt did not have any pre-vaccination
demyelinating episodes supports that this day was the onset of her disease. This
interval fits the range Dr. Tornatore proposed. Thus, Ms. Hitt has carried her
burden in establishing a proximate temporal relationship between the flu
vaccination and her injury.
V. Conclusion
Accordingly, Ms. Hitt has established that the flu vaccination was the cause-
in-fact of her injury. Therefore, she is entitled to compensation under the Vaccine
Act.
An order regarding damages will be issued shortly.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
17

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DOCUMENT 2: USCOURTS-cofc-1_15-vv-01283-1
Date issued/filed: 2021-08-13
Pages: 13
Docket text: PUBLIC DECISION (Originally filed: 7/29/2021) regarding 162 DECISION of Special Master. Signed by Special Master Christian J. Moran. (Attachments: # (1) Appendix Future Unreimbursed Expenses, # (2) Appendix Future Pain, Suffering, and Emotional Distress) (jmw) Service on parties made.
--------------------------------------------------------------------------------
Case 1:15-vv-01283-UNJ Document 163 Filed 08/13/21 Page 1 of 13
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
ANNA HITT, *
* No. 15-1283V
Petitioner, * Special Master Christian J. Moran
*
v. * Filed: July 29, 2021
*
SECRETARY OF HEALTH * Damages, multiple sclerosis,
AND HUMAN SERVICES, * pain, suffering and emotional
* distress
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Renee Gentry, Washington, DC, for petitioner;
Kimberly S. Davey, United States Dep’t of Justice, Washington, DC, for
respondent.
DECISION AWARDING COMPENSATION1
Ms. Hitt established that an influenza (“flu”) vaccine caused her to suffer
from multiple sclerosis. Ruling, issued January 24, 2020. The parties, however,
disagreed regarding the amount of compensation to which Ms. Hitt was entitled
and the case proceeded to a hearing. Ms. Hitt is awarded $469,237.53.
1 The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), requires that the Court post this decision on its
website (http://www.cofc.uscourts.gov/aggregator/sources/7). Pursuant to Vaccine Rule 18(b),
the parties have 14 days to file a motion proposing redaction of medical information or other
information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special
master will appear in the document posted on the website.

Case 1:15-vv-01283-UNJ Document 163 Filed 08/13/21 Page 2 of 13
I. Facts2
Ms. Hitt was born in 1986. Tr. 10. By 2021, she had reached the age of 35
years and had a life expectancy of 48.4 years. Exhibit L.
Before the vaccination, Ms. Hitt’s health was good. Tr. 320. She competed
in the javelin for a division one college athletic program. Tr. 218. After
graduating from college, Ms. Hitt started nursing school. Tr. 218-19.
As part of her employment at a hospital, Ms. Hitt received a flu vaccination
on October 23, 2014. Exhibit 13 at 2; Tr. 220. She experienced numbness in her
legs and a physical therapist referred her to a doctor. Exhibit 8 at 5-8. The doctor,
in turn, ordered an MRI.
When Ms. Hitt and her husband learned that the MRI indicated that she had
multiple sclerosis, they were shocked and dismayed. Their testimony about the
evening in which they learned about this diagnosis was poignant. Tr. 223-29, 320-
21.
Based in part on the results of the MRI, April Erwin, a neurologist began
treating Ms. Hitt. Dr. Erwin diagnosed Ms. Hitt as suffering from multiple
sclerosis in December 2014. Dr. Erwin prescribed Tecfidera. Exhibit 11 at 10-11.
Multiple sclerosis (“MS”) is an autoimmune disease, a non-compressive
myelopathy. Tr. at 80-82. MS may be “acute and subacute and chronic,”
implicating multiple parts of the spinal cord. Id. Initially, a patient may be
diagnosed with transverse myelitis, a clinically isolated syndrome recognized to be
causing demyelination. Tr. 56-57. Subsequent events disseminated in time, space,
and throughout the nervous system are suggestive of MS. Tr. 57-59; see also
exhibit A-13, at 1 (stating “Diagnostic criteria for multiple sclerosis (MS) include
clinical and paraclinical laboratory assessments emphasizing the need to
demonstrate dissemination of lesions in space (DIS) and time (DIT)”).
After taking Tecfidera for a period, Ms. Hitt and her husband decided to
have a baby. Accordingly, Ms. Hitt paused any medications. During her
2 Additional information can be found in the Ruling Finding Entitlement, issued January
24, 2020.
3 Exhibit A-1 is Chris Polman et al., Diagnostic Criteria for Multiple Sclerosis: 2010
Revisions to the McDonald Criteria, 69 ANNALS OF NEUROLOGY 292 (2011).
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pregnancy Ms. Hitt’s multiple sclerosis was relatively calm. Ms. Hitt delivered a
baby in August 2016. Tr. 31-32.
After Ms. Hitt gave birth, Dr. Erwin wanted to reinstate medications.
However, Ms. Hitt wanted to breast-feed, and worried medications would
complicate her baby’s health. Because Ms. Hitt’s MRIs were good, Dr. Erwin
agreed to defer resumption of medications. See Tr. 32-33.
As a new mom, Ms. Hitt switched jobs. She stopped working as an ICU
nurse and began working as a sales representative. See Exhibit 114 at 7 (summary
of career). As a sales representative, Ms. Hitt visited doctor’s offices. Tr. 241-
242; 272.
On Monday, July 24, 2017, Ms. Hitt dropped her daughter off at daycare and
then drove to a medical building in which Dr. Erwin’s office was located
coincidently. Ms. Hitt, as a sales representative, had an appointment to see a
neurosurgeon there. Tr. 242, 243. In the reception area of the neurosurgeon’s
office, Ms. Hitt suffered a grand mal seizure. Ms. Hitt was taken to a local
hospital. See exhibit 40 at 19. She was evaluated and released from the
emergency room. Tr. 272. Later, an MRI detected a lesion in her temporal lobe.
Exhibit 39 at 13.
This grand mal seizure disrupted Ms. Hitt’s life for six months. Louisiana
law prevented Ms. Hitt from driving a car. Consequently, she stopped working as
a sales representative because she could not get to her appointments. Tr. 245. As
additional precautions, Ms. Hitt could not bathe her daughter in a bathtub alone
and she could not cook. Tr. 245. She missed events at her daughter’s school. Tr.
325. She felt guilty for not being present at every event. Id. Not being able to get
her family groceries or to drive her daughter to school left Ms. Hitt feeling
dependent despite being an adult. Tr. 294.
In these six months, she began a more expensive and aggressive MS
treatment protocol. Due to the treatment plan, she had to stop breastfeeding, “the
one thing that came naturally and easily to [her] as a mother”. Exhibit 101 at 2.
Ms. Hitt had another MRI on September 29, 2017. Exhibit 97 at 89-90. Her
husband reported that her anxiety levels picked up during the weeks and days prior
to MRIs. Tr. 326.
Once those six months past and Ms. Hitt did not experience more seizures,
her life returned to “normal,” a term that encompasses having multiple sclerosis.
She started a job working part-time as a nurse, caring for patients with heart
3

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conditions.4 Ms. Hitt traveled by plane for vacations. She and her family also took
trips to the mountains and beaches. Exhibit 101 (affidavit) ¶ 2; Tr. 289; Tr. 330.
Ms. Hitt has continued to see Dr. Erwin. According to Dr. Erwin, Dr. Erwin
has treated Ms. Hitt’s multiple sclerosis aggressively. In spring 2018, Ms. Hitt
began taking a new medication, Lemtrada. Exhibit 39 at 10, 25; exhibit 97 at 54;
Tr. 236. The first course of Lemtrada is administered by IV over five days.
During this infusion, Ms. Hitt felt bloated and distended. Tr. 249.
According to information Ms. Hitt relayed from Dr. Erwin, Lemtrada
attempts to reset the body’s immune system. Tr. 248. Specifically, Lemtrada
suppresses production of T cells, which target viruses. Thus, while Lemtrada
might prevent the body from attacking itself (and causing a multiple sclerosis
flare), Lemtrada also makes a person vulnerable to outside infections. Ms. Hitt
was prescribed Valtrex prophylactically to prevent herpes. For a few months while
Ms. Hitt’s T cells were increasing, she had to take additional steps to protect
herself. She was encouraged to stay home to minimize exposure to potentially sick
people. Tr. 250-51, 272, 324. When Ms. Hitt did leave the house, she wore a
mask.5 When her daughter developed hand, foot, and mouth disease, Ms. Hitt
could not care for her. Tr. 252, 293.
While the depletion of Ms. Hitt’s immune system due to Lemtrada was
temporary, Lemtrada also caused another side effect. Ms. Hitt’s thyroid levels first
became very elevated, then very decreased.6 Tr. 256-57. An endocrinologist
diagnosed Ms. Hitt with Hashimoto’s thyroiditis. For this problem, Ms. Hitt will
take a pill for the remainder of her life. Tr. 256, 263, 294.
The thyroid trouble, in turn, has complicated efforts for Ms. Hitt and her
husband to expand their family. Ms. Hitt has consulted a fertility specialist,
although she did not produce any medical records from this doctor.
Since the official diagnosis of multiple sclerosis in December 2014 through
Ms. Hitt’s testimony at the May 20, 2021 hearing, she has experienced little
physical pain. Tr. 298, 331. Her multiple sclerosis presented with numbness and
even this symptom has dissipated. She has retained her ability to walk and to
4 The Corona virus pandemic caused some changes in Ms. Hitt's job.
5 Ms. Hitt took these precautions in 2018, two years before the Corona virus pandemic.
One of her friends joked Ms. Hitt was quarantining before it was cool. Tr. 251.
6 The Secretary agreed that Lemtrada can cause thyroid problems. Tr. 351.
4

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perform activities of daily living. She is working part-time in a job she loves. Tr.
282. She tries to emphasize what she can do, not her limitations. Ms. Hitt
exercises as a way to respond to stress. Tr. 313.
Nevertheless, suffering multiple sclerosis worries her, at least occasionally.
A concrete fear is that the events of July 24, 2017 will repeat but less fortuitously.
Ms. Hitt could have a seizure while she is driving, and the results could be
“catastrophic.” Tr. 324; accord Tr. 245-46, 295.
Apparently minor health problems alarm Ms. Hitt. For example, she has
feared that a decrease in her visual acuity is not typical age-related degeneration
but actually a herald of optic neuritis due to multiple sclerosis. Likewise, even a
headache makes Ms. Hitt wonder whether it is just a “headache.” Tr. 237, 284. A
constant shadow or veil floats over her life. Tr. 260, 262, 326.
Ms. Hitt assessed her level of anxiety over the month preceding the hearing
as a 7-8/10. Tr. 299; see also Tr. 332 (Mr. Hitt rated the anxiety as 8-9). This
level reflected preparation to testifying, a process that entailed reviewing events
about which Ms. Hitt would prefer not to dwell. When the litigation is removed,
Ms. Hitt still experiences anxiety. Tr. 299-300. She described multiple sclerosis
as a “sleeping beast.” Tr. 300.
To respond to the anxiety, Ms. Hitt exercises. Tr. 297, 329. Her faith and
church community comfort her. Tr. 291. Ms. Hitt has visited a mental health
counselor (Tr. 314, 333), but no medical records were filed.
II. Procedural History
Ms. Hitt filed her petition on October 29, 2015, claiming a flu vaccine
caused her to suffer from TM and then MS. The Secretary filed his Rule 4 Report
on February 29, 2016. Both parties retained experts and filed multiple reports.
Subsequently, the parties were directed to file briefs.
An entitlement hearing was held on April 17, 2018. Following the hearing,
the parties discussed informal resolution for many months. The parties did not
agree to resolve the case and suggested a schedule for submission of briefs. After
submitting their briefs, the undersigned resolved the question of entitlement, ruling
in favor of Ms. Hitt on January 24, 2020. The case proceeded into the damages
phase. Order, issued Jan. 28, 2020.
Over the next several months, Ms. Hitt filed additional documentation
showing medical expenses and hospital visits. However, efforts were somewhat
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delayed by the pandemic. On September 18, 2020, Ms. Hitt filed a status report
discussing her damages proposal. Ms. Hitt continued to search for and submitted
more records. She filed her final damages proposal on March 8, 2021.
On April 22, 2021, respondent filed his brief on pain and suffering. Ms. Hitt
then filed her pain and suffering brief on May 3, 2021. With these filings, the
parties proceeded to a damages hearing on May 20, 2021.
This matter is now ripe for adjudication.
III. Standards for Adjudication
Petitioners bear the burden of establishing elements of compensation by a
preponderance of the evidence. 42 U.S.C. § 300aa–13(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 & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010)
(citations omitted).
IV. Analysis
Ms. Hitt’s request for compensation includes four components. These are
discussed below.
A. Lost Earnings
Ms. Hitt proposed $106,174.37. Exhibit 114 at 8. The Secretary accepted
the basic calculations and reduced for taxes, leaving $79,064.95. Resp’t’s Supp’l
Br., filed March 29, 2021, at 2; exhibit I. Ms. Hitt agreed to this proposal during
an April 14, 2021 status conference; see also Tr. 218. Thus, Ms. Hitt is awarded
$79,064.95 in lost earnings.
B. Unreimbursed Expenses – Past
Ms. Hitt proposed $14,529.28. Exhibits 114-15. The Secretary accepted
$13,633.93. Resp’t’s Supp’l Br., filed March 29, 2021, at 2. The difference was
that the Secretary rejected some invoices due to a lack of documentation that the
bills were paid.
In her oral testimony, Ms. Hitt stated she paid those invoices. She also
testified about efforts to obtain documentation of payment. Tr. 214-18. Although
the Secretary cross-examined Ms. Hitt, the Secretary did not ask any questions on
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this point. See Tr. 269-75. Accordingly, Ms. Hitt is awarded $14,529.28 in past
unreimbursed medical expenses.7
C. Unreimbursed Expenses – Future
Ms. Hitt receives benefits from a health insurance plan her husband’s
employer offers. Under this policy, Ms. Hitt must pay a deductible of $500 per
year initially. After Ms. Hitt pays that deductible, the insurance company
reimburses medical expenses at a certain percentage until Ms. Hitt pays a
maximum of $3,500 per year. Ms. Hitt’s payment of $500 counts towards the
maximum payment.
The parties agree Ms. Hitt requires annual appointments with her neurologist
and MRI scans to monitor her multiple sclerosis. Ms. Hitt is likely to need
medications. Accordingly, the parties agreed that $3,500 per year is an appropriate
amount for one aspect of future unreimbursed medical expenses. Resp’t’s Obj.,
filed May 24, 2021.
Ms. Hitt also requests reimbursement for mileage expenses. She estimated
that she drives 500 miles per year. Exhibit 114 at 3. At the IRS allowed rate of 17
cents per mile, Ms. Hitt’s annual expense is $85.
The component of future unreimbursed medical expenses must be reduced to
net present value. 42 U.S.C. § 300aa–15(f)(4).
D. Pain and Suffering and Emotional Distress
The Vaccine Act states that compensation shall include “(4) For actual and
projected pain and suffering and emotional distress from the vaccine-related injury,
an award not to exceed $250,000.” 42 U.S.C. § 300aa–15(a).
Factors relevant to this element of compensation are “[(1)] the ability to
understand the injury, i.e., the injured’s mental faculties are intact; [(2)] the degree
of severity of the injury; and [(3)] the potential number of years the individual is
subjected to the injury.” McAllister v. Sec’y of Health & Human Servs., No. 91-
7 Whether testimony via an affidavit, which is not subject to cross-examination, would
constitute preponderate evidence that bills were paid is not presented here. Ms. Hitt appeared
truthful in her oral testimony. See Andreu v. Sec’y of Health and Human Servs., 569 F.3d 1367,
1379 (2009) (explaining that trial courts make credibility determinations in order to assess the
candor of fact witnesses).
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1037V, 1993 WL 777030, at *3 (Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated and
remanded on other grounds, 70 F.3d 1240 (Fed. Cir. 1995).
This section of the Vaccine Act recognizes three components: “pain and
suffering and emotional distress.” A basic tenet of statutory interpretation is to
construe the meaning of a statute so that each part has meaning. See Calendria v.
U.S., 5 Cl.Ct. 266 (1984) (stating that “each section or part of a particular statute
must be construed in relation to each other section or part ‘so as to produce a
harmonious whole.’”) (citing 2A Sutherland, Statutes and Statutory Construction §
46.05, at 56 (C. Sands rev. ed. 1973)); see also Flowers v. Sec’y of Health and
Human Servs., 49 F.3d 1558, 1560 (1995) (“[o]ur statutory interpretation begins
with the language of the statute itself, which must be ordinarily regarded as
conclusive absent a clearly expressive legislative intent to the contrary.”).
While the terms “pain” “suffering,” and “emotional distress” connote similar
concepts, they are not identical. To understand the meaning of these terms,
consulting a dictionary is permitted. See Hervey v. Sec'y of Health & Human
Servs., 88 F.3d 1001, 1002 (Fed.Cir.1996) (using dictionary to define a term in the
Vaccine Act). “Pain” is defined as “2 a: usu. localized physical suffering
associated with a bodily disorder. WEBSTER’S NINTH NEW COLLEGIATE
DICTIONARY 846 (1986).8 Next, “suffer” means “to be subject to disability or
handicap.” Id. at 1179.9 Finally, “distress” means “2 a: pain or suffering affecting
the body, a bodily part, or the mind . . . b. a painful situation.” Id. at 368. This
dictionary further explains “distress implies an external and usu. temporary cause
of great physical or mental strain and stress” and “suffering implies conscious
endurance of pain or distress.” Id.
1. Actual Pain and Suffering and Emotional Distress
The parties value this element differently. Ms. Hitt contends that her past
pain, suffering, and emotional distress warrant compensation more than $250,000.
Thus, petitioner contends she is entitled to the maximum award even without
considering any future pain and suffering and emotional distress. Pet’r’s Br., filed
May 3, 2021. In contrast, the Secretary maintains a reasonable amount of
compensation for Ms. Hitt’s past pain and suffering is $100,000. The Secretary
further recommends that the value of Ms. Hitt’s future pain and suffering is
8 A secondary definition of “pain” is: “b: acute mental or emotional distress or suffering.”
9 Other definitions of “suffer” include: “1: to endure death, pain, or distress 2: to sustain
loss or damage.”
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$1,033.06 per year for the remainder of her life expectancy. This works out to
$50,000 which, after reduction to net present value, equates to $35,899.55.
Resp’t’s Br. filed April 22, 2021; exhibit K.
Ms. Hitt’s case is unusual in two respects. First, relatively few cases have
discussed non-economic damages for multiple sclerosis. Ms. Hitt cited some
cases, which resolved via a stipulation. Pet’r’s Br., filed May 3, 2021, at 4-5,
citing Halcrow v. Sec’y of Health and Human Servs., No. 16-212V (Fed. Cl. Spec.
Mstr. June 3, 2020), and Giordano v. Sec’y of Health and Human Servs., No. 13-
277V (Fed. Cl. Spec. Mstr. May 28, 2019), among other cases. But, as the
Secretary pointed out, the decisions contain nearly no facts, making comparison
challenging. Independent research has turned up relatively few cases. See Jay
Zitter, Annotation, Excessiveness or adequacy of damages awarded for injuries to
nerves or nervous system, 51 A.L.R. 5th 467, § 14 (1997); cf. SGS-92-X003 v.
United States, 118 Fed. Cl. 492, 532 (2014) (declining to award emotional distress
damages to plaintiff who suffered emotional distress in a breach of contract case).
Second, Ms. Hitt’s multiple sclerosis has caused her little pain. The Secretary
emphasizes the relatively mild course of Ms. Hitt’s multiple sclerosis so far.
Resp’t’s Br., filed April 22, 2021, at 2. On the other hand, Ms. Hitt maintains she
has endured “pain, suffering, and exhaustion for nearly 7 years.” Pet’r’s Br., filed
May 3, 2021, at 9.
Of the three terms Congress listed in the Vaccine Act, “pain, suffering, and
emotional distress,” “pain” is perhaps the easiest to understand. As stated above,
“pain” can be linked to the physical suffering associated with a bodily disorder.
While the dictionary’s definition of “pain” is broad enough to include pain
associated with mental distress (see footnote 8, above), the statutory terms
(suffering and emotional distress) encompass that aspect more directly. Thus, the
focus here is Ms. Hitt’s physical pain. While the pain has, at times, been minimal
and even nonexistent, Ms. Hitt has experienced some pain. A reasonable amount
of compensation is $5,000.
The remaining two terms in the Vaccine Act “suffering” and “emotional
distress” are more difficult concepts to parse. But, both flow from the mental (as
opposed to physical) toil an injury causes. As indicated above, “suffering” can
encompass the sensation of being “subject to disability or handicap” as well as the
“conscious endurance of pain or distress.” WEBSTER’S at 1179 and 368.
Here, by this understanding, Ms. Hitt has suffered greatly. The primary part
of compensation should reflect Ms. Hitt’s suffering in being diagnosed with a
chronic condition. Multiple sclerosis is not curable. Neither an operation nor
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physical therapy nor the body’s innate healing processes will cure Ms. Hitt of
multiple sclerosis. Regardless of whether her multiple sclerosis stays relatively
dormant, multiple sclerosis never entirely vanishes. It will remain a “disability”
throughout her life.
Before multiple sclerosis, Ms. Hitt was not concerned about the future. Tr.
320; see also exhibit 14 (affidavit, dated Nov. 23, 2015).10 After receiving the
diagnosis of multiple sclerosis, she has been and remains much more worried about
the future.
In the undersigned’s discretion, the development of a chronic condition like
multiple sclerosis warrants a relatively large amount of compensation. The
chronicity of multiple sclerosis distinguishes it from acute problems such as
Guillain-Barré syndrome for which a good recovery can be expected. While a
Guillain-Barré patient might have different degrees of residual problems, including
paralysis in extreme cases, a person who suffered Guillain-Barré syndrome does
not usually fear a relapse. Multiple sclerosis can bring about – and in Ms. Hitt’s
case did bring about – a change in outlook. Tr. 266 (Ms. Hitt’s testimony
comparing a shift in outlook to the changes after Hurricane Katrina). The same
can also be said for Hashimoto’s thyroiditis but on a lesser scale. While
Hashimoto’s thyroiditis is permanent, it is controlled with medication. For Ms.
Hitt, a reasonable amount of compensation for the emotional distress associated
with being diagnosed with multiple sclerosis and Hashimoto’s thyroiditis is
$175,000. ($150,000 for multiple sclerosis plus $25,000 for Hashimoto’s
thyroiditis).
The remaining term of the relief authorized in section 15(a)(4) is emotional
distress. In the approximately 6.5 years since Ms. Hitt was diagnosed, she has had
a series of episodes that at least temporarily brought about pain in her mind. Ms.
Hitt experienced emotional distress following multiple events, including
experiencing a seizure, losing a driver’s license for six months which caused the
loss of employment, depending upon others for basic chores like bathing her baby
and cooking, and enduring various tests such as MRIs. To a smaller degree, Ms.
Hitt also had emotional distress when her thyroid levels were abnormally high and
then abnormally low. A reasonable amount of compensation for this emotional
distress is $30,000.
10 Ms. Hitt also recognizes that she was aware that anyone's life could turn on a moment
even without multiple sclerosis. Tr. 262.
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Accordingly, a reasonable amount of compensation for Ms. Hitt’s “actual…
pain and suffering and emotional distress” (section 15(a)(4)) is $210,000. This
figure, as explained, derives from the evidence in Ms. Hitt’s case.11
2. Future Pain, Suffering, and Emotional Distress
Because of the award for actual pain suffering and emotional distress does
not exceed the statutory limit, Ms. Hitt is eligible for an award of “projected pain
and suffering and emotional distress.” 42 U.S.C. § 300aa–15(a)(4); see also
Graves v. Sec’y of Health & Human Servs., 109 Fed. Cl. 579, 587 (2013). Ms.
Hitt’s submission on this topic was not helpful. Because she contended that her
actual pain and suffering and emotional distress exceeded $250,000, she presented
no alternative argument for projected compensation. See Pet’r’s Br., filed May 3,
2021. On the other hand, the Secretary made a concrete proposal. Resp’t’s Supp’l
Br., filed April 22, 2021, at 3.
The Secretary contended the activities for which an award of projected pain
and suffering and emotional distress should include Ms. Hitt’s anxiety about
having MRI scans and the inconveniences associated with yearly doctors’
appointments. Tr. 346 (Respondent’s counsel), see also Tr. 300-11 (testimony
about anxiety), 322 (testimony about anxiety).
The Secretary further argued that the chance of a relapse should not factor
into an award of future pain, suffering, and emotional distress. On this question,
the Secretary’s position is well-founded. Ms. Hitt presented very little evidence
about the likelihood of a relapse. For example, Ms. Hitt did not submit any articles
about how often multiple sclerosis relapses. She likewise did not present a report
from a specially retained expert in multiple sclerosis, such as Dr. Tornatore who
testified on her behalf in the entitlement hearing. The most relevant piece of
evidence was a short, handwritten statement from Dr. Erwin, Ms. Hitt’s treating
neurologist. Dr. Erwin stated the future is “unpredictable.” Exhibit 109 at 1. A
11 Coincidently, the amount awarded here seems to align with the cases Ms. Hitt cited.
To the extent the award to Ms. Hitt exceeds the awards in those other cases, the increased award
is justified for two reasons. First, those cases were decided in 2007-11. Everything else being
equal, inflation means that the awards in those cases should be increased. Second, those cases
were resolved on the basis of compromises. The choice of other petitioners to compromise their
claim, that is to accept a lower amount of compensation in exchange for an expedited recovery,
does not reduce the value of Ms. Hitt's case.
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statement of such uncertainty does not carry Ms. Hitt’s burden of presenting
preponderant evidence that she is likely to suffer a relapse.
In the future, Ms. Hitt is not likely to endure the emotional distress
associated with receiving a new diagnosis of a chronic disease. Ms. Hitt seems to
have resolved to keep a positive attitude, minimizing any emotional distress. Tr.
246, 262.
Without any persuasive evidence that Ms. Hitt’s condition will worsen, the
undersigned finds that Ms. Hitt’s multiple sclerosis is likely to remain as it has
been for the past few years – “stable.” Exhibit 109 (Dr. Erwin’s statement); accord
Tr. 273-74, 283. Ms. Hitt’s recent condition has been relatively pain free. Tr. 298.
But, as the Secretary acknowledged, the absence of physical pain does not
necessarily mean the absence of emotional suffering. Ms. Hitt persuasively and
powerfully explained how a potentially typical and minor health issue can produce
intense anxiety about whether the “sleeping beast” is awakening.
To account for all these factors, a reasonable amount of compensation for
projected pain, suffering, and emotional distress is $2500 per year. This amount,
in turn must be reduced to net present value.
E. Summary
Item Current Value
Lost Earnings $79,064.95
Unreimbursed Medical Expenses $14,529.28
Total for Past (excluding pain, suffering and emotional $93,594.23
distress)
FUTURE
Item Annual Award Present Value
Unreimbursed Medical Expenses $3,585.00 $125,643.30
PAIN, SUFFERING AND EMOTIONAL DISTRESS
Item Annual Award Present Value
Past Emotional Distress $175,000.00
Past Suffering $30,000.00
Past Pain $5,000.00
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Pain, suffering and emotional distress $2,500.00 $87,617.36
Total for Pain, Suffering and Emotional Distress $297,617.36
Statutory Cap $250,000.00
Total Compensation $469,237.53
V. Conclusion
Earlier in this litigation, Ms. Hitt established that she was entitled to
compensation. The evidence now shows that a Ms. Hitt is entitled to
compensation in the amount of $469,237.53 to be issued in the form of a check
payable to petitioner. This amount reflects $250,000 for pain, suffering, and
emotional distress; $93,594.23 for past unreimbursed expenses, consisting of
$79,064.95 in lost earnings and $14,529.28 in unreimbursed medical expenses; and
$125,643.30 as the present value of future unreimbursed expenses.
The Clerk’s Office is instructed to enter judgment in accord with this
decision unless a motion for review is filed. Information about the submission for
a motion for review, including deadlines, is presented in the Vaccine Rules, which
are available through the Court’s website.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
13