noting that in the absence of evidence of bad faith, the special master was justified in presuming the existence of good faith
How later courts described this case
- noting that in the absence of evidence of bad faith, the special master was justified in presuming the existence of good faith
- affirming the special master's finding that petitioner's condition was not inconsistent with the disease generally and not affected by the vaccinations
- noting that “the government bears the burden of establishing alternative causation . . . once the petitioner has established a prima facie case.”
Written by the judges who cited it.
The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: February 22, 2021
* * * * * * * * * * * * * * **
DONNA WISSBAUM, * No. 17-1531
*
Petitioner, * Special Master Sanders
*
v. *
* Attorneys’ Fees and Costs;
SECRETARY OF HEALTH * Reasonable Basis; Influenza (“Flu”)
AND HUMAN SERVICES, * Vaccine; Pneumococcal Vaccine;
* Neuromyelitis Optica (“NMO”);
Respondent. * Significant Aggravation.
* * * * * * * * * * * * * * **
John F. McHugh, Law Office of John McHugh, New York, NY, for Petitioner.
Althea W. Davis, U.S. Department of Justice, Washington, DC, for Respondent.
ATTORNEYS’ FEES AND COSTS DECISION 1
On October 16, 2017, Donna Wissbaum (“Petitioner”) filed a petition for compensation
pursuant to the National Vaccine Injury Compensation Program (“Program” or “Vaccine
Program”). 2 Petitioner alleged that the pneumococcal and influenza (“flu”) vaccines she received
on October 22, 2014, caused her to suffer “a significant aggravation of her underlying condition
of neuromyelitis optica 3 (“NMO”)[.]” Pet. at 1, ECF No. 1. On August 22, 2019, Petitioner filed a
motion to dismiss indicating that after consulting with a second expert, “[P]etitioner does not
believe she has reasonable cause to proceed further.” Pet’r’s Mot. to Dismiss, ECF No. 34. I
granted Petitioner’s motion and dismissed her claim on August 26, 2019. See Decision, ECF No.
35.
1
This Decision shall be posted on the United States Court of Federal Claims’ website, in accordance with
the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of
Electronic Government Services). This means the Decision will be available to anyone with access to
the Internet. In accordance with Vaccine Rule 18(b), a party has 14 days to identify and move to delete
medical or other information that satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the
rule requirement, a motion for redaction must include a proposed redacted Decision. If, upon review, I agree
that the identified material fits within the requirements of that provision, such material will be deleted from
public access.
2
The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-
10 et seq. (hereinafter “Vaccine Act,” “the Act,” or “the Program”).
3
Neuromyelitis optica (“NMO”) is defined as the “combined, but not usually clinically simultaneous,
demyelination of the optic nerve and the spinal cord; it is marked by diminution of vision and possibly
blindness, flaccid paralysis of the extremities, and sensory and genitourinary disturbances. Called also
Devic disease[.]” Dorland’s Illustrated Medical Dictionary 1263, 1267 (32nd ed. 2012) [hereinafter
“Dorland’s”].
On January 9, 2020, Petitioner filed a motion for attorneys’ fees and costs, seeking
$13,344.25 in attorneys’ fees and $3,500.00 in costs for her attorney, John F. McHugh. Pet’r’s
Mot. for Attys’ Fees and Costs at Ex. 1, ECF No. 38 [hereinafter Pet’r’s Mot. for AFC]. Petitioner
also seeks an award of $2,972.00 in attorneys’ fees and $284.83 in costs for her prior attorneys at
the law firm of Krueger & Hernandez. Id. at Ex. 2. On January 31, 2020, Respondent filed his
response to Petitioner’s motion, objecting to “an award of attorneys’ fees and costs in this case as
the case lacked a reasonable basis when filed.” Resp’t’s Resp. at 8, ECF No. 39. Alternatively,
Respondent “opposes an award [] for all work done after the Rule 5 conference on October 24,
2018.” Id. Petitioner did not file a reply brief. For the reasons stated below, I find that Petitioner
has not satisfied the statutory requirements for an award of attorneys’ fees and costs; therefore, I
DENY Petitioner’s motion.
I. Procedural History
Petitioner filed her petition for compensation on October 16, 2017. Pet. at 1. At the time the
petition was filed, Petitioner appeared pro se. See id. On January 3, 2018, Petitioner filed a
consented motion to substitute attorney Stephanie A. Schmitt of the firm of Krueger & Hernandez,
in place of Petitioner. ECF No. 8. Petitioner’s request was granted. See ECF Nos. 9–10. On
February 19, 2018, Petitioner submitted six exhibits in support of her petition consisting of medical
records and a statement of completion. ECF Nos. 12–13.
Respondent filed his Rule 4(c) report on September 24, 2018, and recommended against
compensation. Resp’t’s Report at 1, ECF No. 19. Respondent argued Petitioner’s claim with
respect to her pneumococcal vaccine should be dismissed because it is a non-covered vaccine. Id.
at 18. Further, Respondent argued Petitioner’s claim that her flu vaccine caused the significant
aggravation of her NMO must also fail because she has not established causation-in-fact. Id. at
18–21. Respondent also argued that Petitioner failed to provide a medically acceptable timeframe
within which her injury could be ascribed to her flu vaccine. Id.
I held a status conference pursuant to Rule 5 with the parties on October 24, 2018. See Min.
Entry, docketed Oct. 24, 2018. Attorney Andrew Krueger appeared in place of Stephanie Schmitt
for Petitioner, and Althea Davis appeared for Respondent. See Sched. Order at 1, ECF No. 20.
During the conference, Petitioner conceded that the Court did not have subject matter jurisdiction
over Petitioner’s claims related to the pneumococcal vaccine. Id. In relation to Petitioner’s claim
regarding the flu vaccine, I explained “that NMO is a disease that has a tendency to relapse,
especially if a patient does not receive continued treatment as soon as possible.” Id. I noted that
Petitioner “had stopped taking her medication for several days and had begun to relapse prior to
her vaccination.” Id. I further noted that her “symptoms subsided with renewed treatment.” Id. I
highlighted that Petitioner had declined continued treatment for her condition. Id. After discussing
those issues with the parties, I reminded Petitioner that “temporal association does not establish
causation and that the claims of a Petitioner, unsubstantiated by medical records or opinion, do not
establish entitlement.” Id. I informed Petitioner that “reasonable basis may be questioned going
forward in this case, particularly if no expert is obtained.” Id. at 1–2. Nonetheless, Petitioner
indicated a desire to retain an expert and requested ninety days to do so, or until January 22, 2019.
Id. at 2. I granted Petitioner’s request without objection. Id.
2
On December 31, 2018, attorney John McHugh submitted a motion seeking “to take over
[this] case from the office of Andrew Krueger, Esq.” ECF No. 21. Due to several consecutive filing
errors in Mr. McHugh’s motion, he was required to refile his motion two separate times. See ECF
Nos. 21–25. Therefore, the Court did not grant his request to substitute as counsel until March 1,
2019. ECF No. 25. Within Mr. McHugh’s motion, he asked the Court to extend the deadline for
Petitioner’s expert report by “[sixty] days from the date such application is granted.” Id. at 1–2. In
granting his motion to substitute as counsel, the Clerk of Court also granted Mr. McHugh’s request
for an extension. Id. As a result, Petitioner’s deadline to file an expert report was extended until
May 1, 2019. See Order, ECF No. 27. Petitioner missed this deadline.
On June 4, 2019, Petitioner filed a motion for extension of time until August 15, 2019, to file
an expert report. ECF No. 26. Petitioner indicated that “[t]here is a reasonable basis issue in this
case and [she] ha[s] asked for a preliminary opinion from [her] expert before [she] commit[s]
significant funds to obtaining a written opinion.” 4 Id. at 1. On June 5, 2019, I granted in-part
Petitioner’s motion for an extension of time to file her expert report. Order, ECF No. 27. I noted
that Petitioner had been afforded “two-hundred and twenty-four days to file an expert report
addressing concerns raised in the Rule 5 conference[]” but had not done so. Id. at 1. I therefore
ordered Petitioner to submit an expert report by no later than July 5, 2019. Id. at 2.
Petitioner missed her July 5, 2019 deadline. On July 10, 2019, Petitioner moved for leave to
file her status report out of time. ECF No. 28. In her status report, Petitioner indicated that the
preliminary opinion of her expert was that “[Petitioner] must add another expert to the team to
proceed[.]” Id. at 1. As a result, Petitioner would need additional time to locate that expert. Id. In
response, on July 11, 2019, I issued an order to show cause, declining to extend Petitioner’s
deadline for filing an expert report. ECF No. 29. Instead, I ordered Petitioner to show cause why
her case should not be dismissed for failure to prosecute. Id. at 2. I warned Petitioner that failure
to file an expert report by August 9, 2019, would result in an order dismissing her case. Id.
On August 1, 2019, Petitioner filed a status report expressing she was now “seeking to
mediate this case[.]” ECF No. 30 at 1. Petitioner explained that “the facts known indicate that the
damages attributable to the vaccine injury are not significant enough to justify the expense to be
imposed on the [P]rogram by [P]etitioner’s employing experts.” 5 Id. Petitioner indicated that after
her current attorney, Mr. McHugh, had “time to study this matter and to consult informally with
relevant experts, the [P]etitioner now seeks mediation as though [P]etitioner had reasonable cause
to bring this action and has stated a claim for damages . . .” related to vaccine causation. Id. at 4.
As an alternative to mediation, Petitioner moved for an order from me stating that “as of this
submission[, Petitioner] had reasonable cause to proceed and to retain the expert help needed to
proceed.” Id. at 10.
Instead, on August 6, 2019, I issued a second order to show cause. ECF No. 31. In my order,
I concluded that Petitioner’s status report was non-responsive to my initial show cause order. Id.
4
Petitioner’s billing records note that Petitioner’s counsel did not contact Dr. Shoenfeld with a summary
of the case and requesting a possible opinion until June 7, 2019. Pet’r’s Mot. for AFC at Ex. 2, pg. 2.
5
Petitioner’s billing records note that Petitioner’s counsel received a preliminary opinion from Dr.
Kinsbourne regarding the impossibility of Petitioner’s claim on July 27, 2019. Pet’r’s Mot. for AFC at 3,
Ex. 2, pg. 2.
3
at 1. I explained that “I have already alerted Petitioner to a possible reasonable basis issue in my
order dated June 5, 2019, and I will not make a final reasonable basis determination in a vacuum[,]”
as Petitioner requested. Id. I awarded Petitioner one final opportunity to show cause why her case
should not be dismissed. Id. at 2. I ordered her to submit an expert report by August 12, 2019, and
informed her that I would dismiss her case for failure to prosecute if she did not comply. Id.
On August 7, 2019, Petitioner filed a motion to dismiss indicating that “[she] has been
informed that the government questions whether reasonable cause existed to file this action.” ECF
No. 32. Petitioner confirmed that she “underst[ood] that as causation is immune and the injury is
neurological, two medical experts will be required to prosecute this matter.” Id. at 1–2. Therefore,
“[P]etitioner cannot risk incurring the cost of those expert reports.” Id. at 2. Thus, Petitioner moved
for a decision dismissing her claim. Id. I held a status conference with the parties on August 16,
2019, for further information regarding Petitioner’s motion. See Min. Entry, docketed Aug. 16,
2019.
Petitioner filed a second motion to dismiss on August 22, 2019. ECF No. 34. In her motion,
Petitioner indicated that “[i]t was not apparent until we consulted with a second expert, a
neurologist, that this claim could not be proved.” Id. at 1. Petitioner conceded that the expert
preliminarily opined that “it was impossible to isolate the likely vaccine injury from the resurgence
and worsening of her pre[-]existing disability caused by termination of steroid treatment.” Id. at 2.
Petitioner concluded that “having received these opinions [she] does not believe she has reasonable
cause to proceed further.” Id. Petitioner again moved for an order dismissing her claim. Id. I
dismissed Petitioner’s claim for insufficient proof on August 26, 2019. See Decision, ECF No. 35.
On January 9, 2020, Petitioner filed a motion for attorneys’ fees and costs for both firms who
represented her. Pet’r’s Mot. for AFC at 5–6. Petitioner seeks an award of $16,844.25 in fees and
costs for her attorney, Mr. McHugh, and an additional award of $3,256.83 in fees and costs for the
Krueger & Hernandez firm. Id. On January 31, 2020, Respondent filed his response to Petitioner’s
motion, objecting to “an award of attorneys’ fees and costs in this case as the case lacked a
reasonable basis when filed.” Resp’t’s Resp. at 5. Petitioner did not file a reply brief. This matter
is now ripe for consideration.
II. Medical History
a. Medical Records: pre-vaccination
Petitioner was born on December 3, 1956. Pet’r’s Ex. 2a at 40, ECF No. 12-2. In October
2014, at the time of vaccination, she was fifty-seven years old and worked as an attorney. Id.
Petitioner’s pre-vaccination history is relevant for various issues with her vision including optic
neuritis. Id. at 1, 41. On February 20, 2012, Petitioner presented to optometrist Dennis Harkins for
a complete eye exam. Id. Petitioner noted that her vision was blurry at some angles while wearing
glasses. Id. at 1. She also reported a medical history of “[m]igraine without aura, without mention
of intractable migraine without mention of status migrainosus[]” and eustachian tube dysfunction.
Id. Her vision was 20/20. Id. at 5. Dr. Harkins assessed Petitioner with hypermetropia. 6 Id. at 2.
6
Hypermetropia is also referred to as “hyperopia” and is defined as “an error of refraction in which rays of
light entering the eye parallel to the optic axis are brought to a focus behind the retina, as a result of the
4
On December 23, 2013, Petitioner again visited Dr. Harkins and complained of blurry
vision in her right eye. Id. at 40. Petitioner reported that her blurred vision had been occurring “for
awhile, [sic] maybe months,” but that in the last week, she started having blurred vision in the top
half of her vision that “bother[ed] her ability to work.” Id. Dr. Harkins assessed Petitioner as having
blurred vision in her right eye, drusen (degenerative) of retina, 7 visual field loss, rapid afferent
pupillary defect, 8 hyperopia 9 with astigmatism, 10 and presbyopia. 11 Id. at 41. He referred her to
Dr. Robert Weir for treatment of “suspected optic neuritis.” Id.
The next day, on December 24, 2013, Petitioner presented to ophthalmologist Dr. Weir for
suspected optic neuritis. Id. at 69. Petitioner reported that the “[t]op half of [her] vision in [her]
right eye seems wavy,” and that she noticed the change “about [one] week ago and thought it was
due to cold medications.” Id. Testing confirmed the partial loss of vision in her right eye, with
normal vision in her left eye. Id. at 69–70. A brain MRI was conducted on December 31, 2013,
and showed “mild[,] scattered[,] non[-]specific white matter signal abnormality[]” that “could
potentially represent demyelinating process given right optic neuritis.” Id. at 112.
Petitioner followed-up with ophthalmologist Dr. Judith Fitzgerald on December 31, 2013,
to discuss the results of her MRI. Id. at 129. Dr. Fitzgerald definitively diagnosed Petitioner with
optic neuritis and possible multiple sclerosis (“MS”). Id. at 130. Dr. Fitzgerald prescribed
Petitioner steroid infusions for the subsequent three days, and prednisone for eleven days following
the infusions. Id. at 130–131. Dr. Fitzgerald referred Petitioner to Dr. Frost, a neurologist, for
work-up of her possible MS. Id. She also ordered an MRI of Petitioner’s cervical region to rule
out transverse myelitis. Id. On January 1, 2014, Dr. Fitzgerald informed Petitioner that “there was
no transverse myelitis but that there was a fair amount of arthropathy 12 in the cervical region.” Id.
at 143. Dr. Fitzgerald noted that Petitioner “reported that she now has no pain and that she can see
blues and greens now but no reds and that the central vision is a little better.” Id. Petitioner
continued her steroid treatment. Id.
On January 6, 2014, Petitioner reported to Dr. Sarah Groskreutz for follow-up for her optic
neuritis. Id. at 148. During this visit, Petitioner indicated she had received three steroid infusions
beginning on January 1, 2014, and was taking oral steroids. Id. Petitioner further reported that she
was “[s]till unable to see reds (things appear to be brown)” and bright light continued to bother
her. Id. On January 17, 2014, Petitioner presented to neurologist Dr. Natasha Frost. Id. at 156. Dr.
Frost noted that Petitioner’s vision was slowly improving following treatment with steroids based
eyeball being too short from front to back . . . [c]alled also farsightedness . . . .” Dorland’s at 892 (emphasis
in original).
7
Drusen (degenerative) of retina refers to “yellow deposits that form under the retina[.] They usually result
from aging, but sometimes occur with pathologic conditions . . . .” Dorland’s at 568.
8
Rapid afferent pupillary defect is a test used to detect Marcus Gunn pupil. Marcus Gunn pupil is defined
as “the defect of pupillary movement . . . .” Dorland’s at 1556.
9
See supra note 6.
10
Astigmatism is “an error of refraction caused by unequal curvature of the refractive surfaces of the eye,
so that a point source of light cannot be brought to a point focus on the retina but is spread over a more or
less diffuse area.” Dorland’s at 168.
11
Presbyopia is defined as “hyperopia [farsightedness] and impairment of vision due to advancing years or
to old age[.]” Dorland’s at 1511.
12
Arthropathy is defined as “any joint disease.” Dorland’s at 158.
5
on Petitioner’s assertion that she was feeling “90% better[,]” with “[n]o pain[ or] other symptoms.”
Id. Petitioner indicated “a little abnormality in color vision.” Id.
Petitioner followed up with Dr. Weir on April 24, 2014. Id. at 178. During this visit, she
reported “feeling good” and that her vision was “fine” with glasses. Id. Petitioner reported “[n]o
problems at this time.” Dr. Weir noted that Petitioner’s optic neuritis had “resolved[.]” Id. at 179.
Petitioner was advised to return for a complete eye exam in a year. Id.
On June 8, 2014, Petitioner reported to the emergency room with a complaint of abdominal
pain for four days. Pet’r’s Ex. 3 at 67–72, ECF No. 12-4. Petitioner was diagnosed with back and
abdominal pain, but no etiology was determined. Id. at 73. Petitioner had a follow-up for these
complaints on June 27, 2014, with PA Kelin O’Donnell. Pet’r’s Ex. 2a at 315. During this visit,
Petitioner reported “[r]ecurrent abdominal bloating/pain with nausea and stool changes.” Id. at
316. A colonoscopy performed on July 21, 2014, revealed “some focal ‘acute’ inflammation as
well as mild ‘chronic’ inflammation.” Id. at 422–23.
On August 18, 2014, Petitioner presented to the emergency room with a three-day history
of “right thigh numbness” and stated her “sensation is ‘70%’ compared to [her] left leg.” Pet’r’s
Ex. 3 at 95. Petitioner also reported she developed right hip pain, as well as back and abdominal
pain with “associated abdominal bloating.” Id. Petitioner’s admission notes indicate her history of
optic neuritis. Id. Following several exams and tests, including x-rays, Petitioner was diagnosed
with “[t]horacic and lumbar muscle spasms[,] meralgia paresthetica[,] 13 [and c]onstipation.” Id. at
100. On August 21, 2014, Petitioner returned to the emergency room for “lower extremity
numbness and inability to empty bladder.” Id. at 121. She reported “the numbness has gotten worse
to the point where she is having difficulty walking . . . .” Id. An MRI of Petitioner’s thoracic spine
revealed “diffuse lesions along the spinal cord possibly consistent with demyelinating disease.”
Id. at 126. Petitioner was admitted for further work-up. Id. Petitioner’s treating neurologist’s
diagnostic impression was “thoracic myelitis in the context of a prior episode of optic neuritis last
winter.” Id. at 129. Petitioner’s treating neurologist further noted her “differential diagnosis
strongly suggests either [MS] or [NMO].” Id. Petitioner was discharged on August 27, 2014, and
was on a high-dose prednisone taper after completing five days of IV Solumedrol 14 therapy. Id. at
138, 141. Petitioner indicated an improvement in her lower extremity numbness. Id. at 138.
On September 4, 2014, Petitioner returned to Dr. Frost to follow up on her hospitalization.
Pet’r’s Ex. 2a at 442. During this visit, Petitioner reported she is “slowly improving but still very
weak and using a walker.” Id. Dr. Frost informed Petitioner that “[h]er NMO antibody [was]
positive and based on this, her current episode of extensive [TM] and her prior optic neuritis . . .
she has [NMO] . . . .” Id. Dr. Frost instructed Petitioner to continue the steroid taper and to start
13
Meralgia paresthetica is “a type of entrapment neuropathy caused by entrapment of the lateral femoral
cutaneous nerve at the inguinal ligament, causing paresthesia, pain, and numbness in the outer surface of
the thigh in the region supplied by the nerve.” Dorland’s at 1136.
14
Solumedrol is a “trademark for a preparation of methylprednisolone sodium succinate.” Dorland’s at
1731. Methylprednisolone sodium succinate “is chiefly used for the rapid achievement of high blood levels
of methylprednisolone in short-term emergency treatment; administered by intramuscular or intravenous
injection.” Dorland’s at 1154. Methylprednisolone is generally used “as an anti[-]inflammatory and
immunosuppressant . . . .” Id.
6
Imuran, 15 but Petitioner indicated she wished to defer treatment with Imuran pending an
evaluation at the Mayo Clinic. Id. at 442, 460.
On October 13, 2014, Petitioner presented to neurologist Dr. Deena Nasr at the Mayo
Clinic for a second opinion regarding her NMO diagnosis and treatment options. Pet’r’s Ex. 4 at
47. Dr. Nasr noted that the onset of Petitioner’s optic neuritis occurred in late December 2013.
Id. She further indicated that following treatment with IV steroids, “[Petitioner’s] vision was back
to baseline within two weeks from onset.” Id. Petitioner underwent a full exam. Id. at 48. The
exam revealed Petitioner had “absent vibration at the toes up to the knees. 50% loss of the
proprioception at the toes. Diminished pinprick in bilateral lower extremity with T8 sensory level
on the right . . . [g]ait was not assessed as [Petitioner] got flexor spasms every time she was asked
to stand.” Id. Based on this exam, Dr. Nasr confirmed Petitioner’s NMO diagnosis and diagnosed
her with paroxysmal flexor spasms. 16 Id. at 48–49. Dr. Nasr ordered additional lab tests, including
repeat ANA and NMO antibody screenings, and prescribed Tegretol. 17 Id. at 49. The same day,
Petitioner saw a second neurologist, Dr. Brian Weinshenker, at the Mayo Clinic. Id. at 50–52. Dr.
Weinshenker indicated that “[t]here is little doubt of the diagnosis of [NMO].” Id. at 52. He
recommended treatment with azathioprine combined with corticosteroids, but Petitioner
expressed a desire to try rituximab 18 first. Id. Prior to starting such treatment, Dr. Weinshenker
further recommended that Petitioner receive both the pneumococcal and inactivated flu vaccines
but stated she should not receive live vaccines. Id.
On October 22, 2014, Petitioner reported to Dr. Marjorie Dimaggio to establish care.
Pet’r’s Ex. 2a at 495. During this visit, Petitioner indicated that “her back pain was improving
with the prednisone but she was instructed to stop this on [the previous] Friday so that she could
have [] recommended immunizations (flu shot and Pneumovax) prior to starting Rituxan per
Mayo Clinic recommendations.” Id. at 496. Petitioner stated that since stopping her prednisone,
she had developed some lower left extremity weakness and her right lower extremity weakness
and pain had worsened. Id. Petitioner received the influenza and pneumococcal 23 polysaccharide
vaccine. Id. Given the severity of Petitioner’s symptoms, she was instructed to resume taking
prednisone the next day after receiving her immunizations. Id.
b. Medical Records: post-vaccination
In the early morning hours of October 24, 2014, Petitioner’s husband called Dr.
Dimaggio’s office and reported that Petitioner received:
15
Imuran is a “trademark for preparations of azathioprine.” Dorland’s at 925. Azathioprine is used as,
among other things, “a disease-modifying antirheumatic drug for treatment of severe, progressive
rheumatoid arthritis . . . .” Dorland’s at 187.
16
Paroxysmal flexor spasms refer to “a sudden recurrence or intensification of symptoms . . . a spasm or
seizure . . . ” in any muscle that flexes a joint. Dorland’s at 717, 1384.
17
Tegretol is a “trademark for preparations of carbamazepine.” Dorland’s at 1877. Carbamazepine is “an
anticonvulsant and antineuralgic, used in the treatment of pain associated with trigeminal neuralgia and in
epilepsy manifested by tonic-clonic and partial seizures[.]” Dorland’s at 287.
18
Rituximab is the generic name for “Rituxan” and may be used interchangeably. Dorland’s at 1650.
Rituximab is defined as “a chimeric murine/human monoclonal antibody . . . in the treatment of [] non-
Hodgkin lymphoma[.]” Id.
7
a pneumonia shot two days ago and since then she has deteriorated – legs are not
working well at all and pain has increased. Tonight[,] she has taken Tramadol with
no relief. She states she gets the most relief from prednisone[] but has taken her
max dose for today already. She is asking if she can take more.
Pet’r’s Ex. 2a at 527. The on-call doctor deferred treatment until speaking with Petitioner’s
neurologist. Id. at 529. During a follow-up call later that day, the on-call nurse noted “[Petitioner]
states that she had worsening leg symptoms when she came off oral steroids but after her flu and
pneumonia shots the leg symptoms are even worse.” Id. at 516. Petitioner further reported “her
legs feel ‘dead’ since getting the pneumonia and flu shot yesterday.” Id. at 517. In response,
between October 24 through October 28, 2014, Petitioner underwent a five-day course of
methylprednisolone infusions. Id. at 530. On October 28, 2014, the final day of treatment,
Petitioner reported that her “[l]eft foot and left leg improved in strength since starting infusion[s]
last Friday [October 24, 2014].” Id. at 537. She also indicated her “[r]ight leg is feeling sensation
more now compared to prior to treatment [and her b]ladder control [is] improving.” Id.
On October 29, 2014, Petitioner presented to rheumatologist Dr. Carol Cox at the request
of Dr. Frost, for an evaluation regarding immunosuppressive therapy for management of her NMO.
Id. at 546–47. Dr. Cox and Petitioner discussed possible immunosuppressive therapy, including
treatment with Rituxan. Id. During this visit, Dr. Cox noted “[Petitioner] had a reaction to the
pneumonia shot.” Id. at 547. Dr. Cox further noted “[Petitioner] reports that her numbness persists
from the waist down but she has been able to regain some movement of the left leg. Her bladder
control is improving.” Id. Dr. Cox indicated that “[g]iven her clinical course . . . it is most
appropriate to start her on Rituxan given the more prompt nature of response.” Id. at 548. Petitioner
received her first Rituxan infusion on November 5, 2014. Id. at 566.
Petitioner established care with a new neurologist, Dr. Michael Snyder, on January 16,
2015. Id. at 622. At the time she presented to Dr. Snyder, Petitioner was on a slow prednisone
taper to help manage her symptoms. Id. at 625. Dr. Snyder’s impression was that Petitioner had
seropositive NMO, spastic quadriparesis with gait impairment, and lower extremity spasticity. Id.
at 624. Dr. Snyder lowered Petitioner’s prednisone dose and recommended Petitioner continue
Rituxan infusions every six months. Id. He further instructed her to continue with physical therapy,
consider treatment with Baclofen “if spasticity worsens or starts to bother her more,” and to follow-
up in three months.” Id. Petitioner followed up with Dr. Snyder on April 9, 2015. Id. at 655. During
this visit, Petitioner reported she was able to walk one-hundred feet with a walker. Id. at 655–56.
Dr. Snyder noted that since her last visit, Petitioner had slowly tapered “completely” off
prednisone “and has not clearly noticed worsening since discontinuing.” Id. at 655. However, he
also indicated Petitioner had persistent weakness and sensory disturbance in her lower extremities.
Id. at 657. Dr. Snyder recommended Petitioner continue with Rituxan. Id.
On May 13, 2015, Petitioner received another Rituxan transfusion. Id. at 671. She reported
“feel[ing] well and [] no new issues since her last infusion.” Id. On May 18, 2015, Petitioner
followed up with her ophthalmologist and reported “[n]o concerns with her eyes or vision[.]” Id.
at 683–84.
Several months later, on September 24, 2015, Petitioner had a follow-up visit with Dr.
8
Weinshenker at the Mayo Clinic. Pet’r’s Ex. 4 at 30. During this visit, Dr. Weinshenker indicated
that “[s]ince starting [Rituxan], [Petitioner] has had no further attacks of optic neuritis, myelitis,
or other new neurologic symptoms.” Id. Upon exam, Dr. Weinshenker noted “[Petitioner] ha[d]
mildly reduced hip flexor strength of both legs[,] . . . moderate to severe spasticity of both legs,
left greater than right, and [] mild spasticity of the left upper extremity.” Id. at 31. He further noted
that, as previously detected, Petitioner had “moderately to severely reduced vibration sense below
the knees[.]” Id. Overall, Dr. Weinshenker indicated Petitioner’s sensory exam had improved since
their last visit but she was still “significantly more impaired functionally.” Id. Dr. Weinshenker
recommended further Rituxan infusions to manage her symptoms. Id. at 32.
Almost a year later, on August 8, 2016, Petitioner returned to Dr. Weinshenker for follow-
up. Id. at 24. Dr. Weinshenker noted that Petitioner had suffered “no further attacks of optic neuritis
and myelitis.” Id. At this visit, Petitioner’s “major complaint [was] discomfort in her legs and
spine.” Id. Dr. Weinshenker determined Petitioner had “a stable residual myelopathy.” Id. at 25.
He recommended Petitioner continue Rituxan infusions every six months and suggested a follow-
up in one year. Id. On May 17, 2017, Petitioner emailed Dr. Weinshenker alerting him that she
was “seriously thinking of discontinuing the [Rituxan] infusions and not replacing it with anything
else . . . .” Id. at 20. Dr. Weinshenker strongly advised Petitioner against this course of action,
noting that she would likely relapse. Id. at 19. He told her that she “should not interpret the fact
that [she] was doing well as indicati[on] that [she] was cured.” Id.
On May 31, 2017, Petitioner presented to another neurologist, Dr. Matthew Raday, for
follow-up. Pet’r’s Ex. 2b at 1302, ECF No. 12-3. Drs. Snyder and Frost were no longer with the
practice. Id. During this visit, Dr. Raday noted Petitioner was “clinically stable on Rituxan.” Id. at
1303. Petitioner returned to Dr. Raday on November 16, 2017. Id. Dr. Raday indicated that
Petitioner “elected to go off Rituxan despite recommendations to remain on it.” Id. Petitioner
reported she “continue[d] to have right arm pain[,]” and “pain in the left distal upper medial arm.”
Id. However, Petitioner maintained she had this “for at least a couple years[,]” prior to
discontinuing Rituxan. Id. Petitioner reported “[n]o changes to vision, if anything she feels that
her vision has been better.” Id. Dr. Raday noted his recommendation against the discontinuation
of Rituxan and advised Petitioner to continue Rituxan infusions to avoid “new neurological deficits
of which she may never recover from.” Id. at 1306. Nonetheless, Petitioner maintained her refusal
to resume treatment and acknowledged her awareness of the possible long-term problems this
presented, including permanent deficits. Id. Dr. Raday noted Petitioner’s intention to keep him
apprised of her symptoms. Id.
Petitioner had another follow-up with Dr. Weinshenker on November 27, 2017. Pet’r’s Ex.
4 at 8. Dr. Weinshenker noted Petitioner’s physical findings were unchanged since her last
evaluation on August 8, 2016. Id. at 9, 24. He also noted Petitioner’s decision to forego Rituxan
infusions due to her concern about the risks to her liver, kidney, and immune system. Id. at 9. Dr.
Weinshenker informed Petitioner that he did not think this decision was “wise” as cessation of
Rituxan “leaves [Petitioner] open for recurrent attacks of [NMO].” Id. Dr. Weinshenker attempted
to reassure Petitioner “that there was no significant risk to her liver or kidney[s], and the potential
effects on her immune system are usually not clinical[ly] important and associated with a low rate
of serious or opportunistic infection.” Id. His efforts were unsuccessful. Petitioner promised to
keep Dr. Weinshenker informed of her symptoms and planned to follow up in a year. Id. No other
9
medical records have been submitted.
c. Preliminary consultations with Petitioner’s experts
According to Petitioner’s billing records, Petitioner contacted Dr. Yehuda Shoenfeld, an
expert in autoimmunity, on June 7, 2019, regarding a preliminary consultation and “possible
opinion.” Pet’r’s Mot. for AFC at 1–2; see also Pet’r’s Mot. for AFC at Ex. 2, pg. 2, ECF No. 38-
2. Notably, by the time Petitioner contacted Dr. Shoenfeld, she had missed her May 1, 2019 expert
report deadline by one month and six days. See Order, ECF No. 27. Nonetheless, Petitioner
indicated that Dr. Shoenfeld provided her with medical literature informing her that “[i]nfluenza[]
vaccination[s] could cause optic neuritis or the aggravation of [the] same[.]” Pet’r’s Mot. for AFC
at 2. Petitioner cited to two articles submitted to her by Dr. Shoenfeld in her motion for attorneys’
fees and costs. Id. at 2–3. However, the articles themselves have not been filed for the record, and
the citations included within Petitioner’s motion are incomplete. See id. Dr. Shoenfeld did not
prepare a formal report, as he indicated that input from an expert in neurology would be necessary
before he could adequately do so. Id. Dr. Shoenfeld billed $2,000 for his services. Id. at 2.
Petitioner consulted with neurologist Dr. Marcel Kinsbourne on July 27, 2019. Id. at Ex.
2, pg. 2. Petitioner indicated that after Dr. Kinsbourne reviewed her file, he advised that:
as [Petitioner’s] medi[c]al team had discontinued steroid treatment of her [optic
neuritis] condition on the Friday before the vaccination and as her report to her
doctors indicated that[,] deterioration of her legs started shortly thereafter and
before the vaccination. Therefore[,] removal of steroid treatment was a non-vaccine
cause which was almost as likely as the vaccine to be responsible for her injury.
Her deterioration was progressing before she was given the vaccination . . . it would
be extremely difficult to distinguish between the effect of the withdrawal of steroid
treatment and the effect of the vaccination.
Pet’r’s Mot. for AFC at 3–4. Dr. Kinsbourne did not prepare a formal report. Id. at 4. He billed for
three hours of work at $500 per hour, for a total of $1,500. Id. Based on the preliminary opinions
of both experts, Petitioner “determined that pursuing this matter further would be expensive, had
only a limited chance of success[,] and could be deemed unreasonable.” Id.
III. Arguments regarding Petitioner’s Motion for Attorneys’ Fees and Costs
a. Petitioner’s Argument
As the issue of reasonable basis had previously been raised in this case, Petitioner addresses
the issue in her motion for attorneys’ fees and costs. Pet’r’s Mot. for AFC at 3. Petitioner argues
that reasonable basis existed to pursue this case. Id. To establish reasonable basis, Petitioner argues
that the evidence provided in this case shows she could satisfy her burden under Althen. 19 Id. at 2–
19
Petitioner erroneously argues that reasonable basis existed in this case because the evidence shows she
could meet her burden under Althen. In doing so, Petitioner misstates both the standard used to evaluate
reasonable basis and the standard applicable to significant aggravation claims. To establish a causal link
between a vaccine and a claimed injury, the Federal Circuit set forth a three-pronged test in Althen. Althen
10
3 (citing Althen v. Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)). In support of that
assertion, Petitioner cites to some of the articles provided by Dr. Shoenfeld. Id. at 2. Petitioner
argues these articles informed her that “[i]nfluenza[] vaccination[s] could cause optic neuritis or
the aggravation of [the] same[.]” Id. Petitioner indicates “[t]he articles established that many
medical researchers agreed that [optic neuritis] following an influenza vaccination was a known
phenomena [sic].” Id. Petitioner argues these articles indicated she could satisfy her burden under
the first and third prongs of Althen. Id.
Petitioner further states that her medical records show “[b]efore the vaccinations, [she] was
on prednisone to control her symptoms and was able to walk and function.” Id. at 3. However, the
day after the vaccinations, her records indicate that “she had no use of her legs[.]” Id. Petitioner
argues that the loss of the use of her legs the day after she received her vaccine is attributed to the
flu vaccination. Id. Petitioner further argues that “[a]s [her] prior condition is known to be one
which could be caused by the [flu] vaccine, it is logical that exposure to this vaccine could also
aggravate that condition.” Id. Based on this, Petitioner argues pursuant to the second prong of
Althen, “that the vaccine was the but[-]for cause of her temporary complete loss of the use of her
legs after the vaccination, and her continued significantly aggravated condition . . . .” Id. Petitioner
further claims she demonstrated she suffered from the “increased disability [aggravated by the
vaccine] . . . for over a year[.]” Id. As such, Petitioner argues “the[re] was reasonable basis to
pursue this case as of the time it was transferred to [counsel’s] office.” Id.
Finally, Petitioner argues that “[d]ue to the [her] medical history, a significant amount of
time was consumed [by counsel] to understand that history and to research the various notations
in the record to determine their significance.” Id. at 5. Petitioner also argues that “the literature
forwarded to [counsel] by Dr. Shoenfeld [sic] had to be reviewed and understood.” Id. Petitioner
states that “[t]he records were then reviewed [] to remove all claims which seemed excessive.” Id.
Based on these actions, Petitioner argues that the request for fees and costs is “accurate” and there
was a reasonable basis to pursue this case “as of the time it was transferred to [counsel’s] office.”
v. Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). The Althen test requires a petitioner to set
forth: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of
cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate
temporal relationship between vaccination and injury.” Id. To establish entitlement to compensation under
the Program, a petitioner is required to establish each of the three prongs of Althen by a preponderance of
the evidence. See id. (internal citations omitted). However, in this case, Petitioner asserts that the flu vaccine
significantly aggravated her pre-existing NMO. The United States Court of Appeals for the Federal Circuit
has held that the Loving test is the correct framework for evaluating an off-Table significant aggravation
claim. See W.C. v. Health & Hum. Servs., 704 F.3d at 1352, 1357 (Fed. Cir. 2013) (citing Loving v. Sec’y
of Health & Hum. Servs., 86 Fed. Cl. 135, 144 (2009)). The Loving test incorporates the three-pronged test
set forth in Althen and adds three additional prongs, which Petitioner must show by a preponderance of the
evidence: (1) the person’s condition prior to administration of the vaccine; (2) the person’s current condition
(or the condition following the vaccination if that is also pertinent); and (3) whether the person’s current
condition constitutes a “significant aggravation” of the person’s condition prior to vaccination. Loving, 86
Fed. Cl. at 144. Therefore, Petitioner’s reliance on Althen is incorrect and misplaced. However, even if
Petitioner had instead applied the standard established in Loving, causation is not determinative in a finding
of reasonable basis. Therefore, Petitioner’s argument that this case had a reasonable basis because she could
show entitlement to compensation under Loving is inapplicable.
11
20
Id. at 3, 5. Petitioner did not file a reply to Respondent’s response.
b. Respondent’s Argument
On January 31, 2020, Respondent filed a response to Petitioner’s motion for attorneys’ fees
and costs. Resp’t’s Resp. Respondent opposes Petitioner’s motion for fees and costs, arguing that
“this case lacked a reasonable basis when it was filed.” Id. at 5. Further, in the alternative,
Respondent opposes an award of attorneys’ fees and costs for work performed after the Rule 5
status conference on October 24, 2018. Id. at 8. Respondent indicates, at that time, Petitioner was
informed that “the claim presented questions about the reasonable basis going forward,
‘particularly if no expert’ report was obtained.” Id. No expert report was obtained.
Respondent indicates that “[t]o ‘have a reasonable basis,’ a claim must, at a minimum, be
supported by medical records or medical opinion.” Id. at 6 (quoting Everett v. Sec’y of Health &
Hum. Servs., No. 91-1115V, 1992 WL 35863, at *2 (Fed. Cl. Spec. Mstr. Feb. 7, 1992)).
Respondent notes that in a reasonable basis inquiry, the Court looks not at the likelihood of success
of the claim, but rather assesses the claim’s feasibility. Id. (citing Perreira v. Sec'y of Health &
Hum. Servs., 33 F.3d 1375, 1377 (Fed. Cir. 1994)). Respondent posits that mere speculation that
a petitioner could or might establish a claim, alone, is not enough to establish reasonable basis; it
must be supported by at least medical records. Id. (citing McKellar v. Sec’y of Health & Hum.
Servs., 101 Fed. Cl. 303, 303 (2011); Everett, 1992 WL 35863, at *2)).
Respondent argues Petitioner’s motion should be denied because “the medical records do
not support [P]etitioner’s claim that she suffered a significant aggravation of her underlying
NMO[,]” as a result of the flu vaccine she received on October 22, 2014. Id. at 7; see also Resp’t’s
Report at 18, 19. Respondent argues it was already documented that Petitioner “suffers from a
disease that is a relapsing and remitting condition with a variable prognosis.” See id. Respondent
notes Petitioner’s medical records show that “[she] had not been taking her prescribed medication
[for her NMO] around the time that she reported worsening of her [NMO] symptoms.” Resp’t’s
Resp. at 7. Specifically, Respondent indicates that Petitioner stopped taking prednisone five days
before receipt of the vaccines. Id. at 8. She then had worsening of her symptoms on the very same
day she received the vaccines. Id. Thus, Respondent argues, “[P]etitioner’s records show[] that her
alleged symptoms of worsening began prior to receipt of the vaccines on October 22, 2014, and
were related to stopping her prednisone.” Id. Therefore, it is apparent Petitioner’s medical records
do not provide support for her claim for significant aggravation and cannot support a finding of
20
In Simmons, the Federal Circuit stated that “while good faith on behalf of [P]etitioner’s counsel is a
subjective inquiry, the question of whether there was reasonable basis for the claim is an objective inquiry.”
Simmons v. Sec’y of Health & Hum. Servs., 128 Fed. Cl. 579, 582 (2016), aff’d, 875 F.3d 632 (Fed. Cir.
2017). The reasonable basis inquiry is unrelated to the conduct of a petitioner’s counsel prior to filing a
claim. Simmons, 875 F.3d at 635. In James-Cornelius, the Federal Circuit reiterated its prior holding in
Cottingham and Simmons, that a reasonable basis analysis is limited to a review of objective evidence.
James-Cornelius v. Sec’y of Health & Hum. Servs., No. 2019-2404, 2021 WL 68806 (Fed. Cir. Jan. 8, 2021)
(citing Cottingham v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1344–45 (Fed. Cir. 2020)); Simmons,
875 F.3d at 635. Subjective considerations, such as counsel’s views on the adequacy of a complaint, are not
considered in a determination of reasonable basis. See id. Therefore, any arguments made by Petitioner
regarding counsel’s subjective actions and beliefs which affected how this case proceeded will not be
considered in my determination of reasonable basis.
12
reasonable basis. Id.
Respondent further argues that even if Petitioner could show she suffered an aggravation
of her NMO, the onset of the worsening of her symptoms occurring within hours of vaccination
was an unreasonable timeframe within which to ascribe causation. Id. at 7. Therefore, based on
Petitioner’s medical records, Respondent argues that there was not enough support filed with this
claim, or at any other time, to support a finding of reasonable basis. Id. at 8.
Finally, Respondent posits that “[p]rior to accepting a case, an attorney should be able to
distinguish a case that has reasonable underpinnings from one that does not.” Id. at 6 (quoting
Murphy v. Sec’y of Health & Hum. Servs., 30 Fed. Cl. 60, 62 (1993), aff’d, 48 F.3d 1236 (Fed. Cir.
1995)). Respondent maintains that “an attorney should use reasoned judgment in determining
whether to accept and pursue a claim.” See id. However, the reasonable basis analysis must turn
on whether there is evidentiary support for the claim, not whether counsel acted reasonably in
filing the petition. Id. at 6 (citing Simmons v. Sec’y of Health & Hum. Servs., 875 F.3d 632, 635
(Fed. Cir. 2017)).
Respondent argues “[P]etitioner’s counsel had a duty to determine whether this case had
reasonable factual underpinnings prior to filing it[]” and he violated that duty. Id. at 7–8 (citing
Murphy, 48 F.3d at 1236). Respondent reiterates his arguments presented above and maintains that
Petitioner’s medical records and preliminary medical opinions show that her alleged worsening of
symptoms began prior to her vaccinations and were related to her stopping prednisone. Id. at 8.
Therefore, Petitioner’s medical records do not provide support for the claim in her petition. Id. As
such, Respondent argues Petitioner’s medical records do not support a reasonable basis to file this
claim, or for counsel to pursue it. Id.; see also Everett, 1992 WL 35863, at *2. Therefore,
Petitioner’s motion for attorneys’ fees and costs must be denied. Resp’t’s Resp. at 7–8.
IV. Legal Standard
Under the Vaccine Act, an award of reasonable attorneys’ fees and costs is presumed where
a petition for compensation is granted. Where compensation is denied, or a petition is dismissed,
as it was in this case, a special master may award fees and costs for an unsuccessful petition if “the
petition was brought in good faith and there was a reasonable basis for the claim for which the
petition was brought.” 42 U.S.C. § 300aa–15(e)(1); see also Sebelius v. Cloer, 569 U.S. 369, 376
(2013).
a. Good Faith
“Good faith” is a subjective standard. Hamrick v. Sec’y of Health & Hum. Servs., No. 99-
683V, 2007 WL 4793152, at *3 (Fed. Cl. Spec. Mstr. Nov. 19, 2007). Petitioners act in “good
faith” if they filed their claims with an honest belief that a vaccine injury occurred. Turner v. Sec’y
of Health & Hum. Servs., No. 99-544V, 2007 WL 4410030, at *5 (Fed. Cl. Spec. Mstr. Nov. 30,
2007). It is, roughly, ‘“an honest belief, the absence of malice and the absence of design to defraud
or to seek an unconscionable advantage.’” Turner, 2007 WL 4410030, at *5 (quoting Black's Law
Dictionary 623 (5th ed.1979)). It is presumed and can be rebutted by direct evidence of bad faith.
Grice v. Sec'y of Health & Hum. Servs., 36 Fed. Cl. 114, 121 (Fed. Cl. 1996) (noting that in the
absence of evidence of bad faith, the special master was justified in presuming the existence of
good faith). Thus, so long as a petitioner had an honest belief that her claim could succeed, the
13
good faith requirement is satisfied. See Riley v. Sec’y of Health & Hum. Servs., No. 09-276V, 2011
WL 2036976, at *2 (Fed. Cl. Spec. Mstr. Apr. 29, 2011) (citing Di Roma v. Sec’y of Health &
Hum. Servs., No. 99-3277, 1993 WL 496981, at *1 (Fed. Cl. Spec. Mstr. Nov. 18, 1992)); Turner,
2007 WL 4410030, at *5. It can be present when the petition is filed and can be lost when the
claim is not maintained in good faith. See Perreira, 33 F.3d at 1377. Conduct of counsel may be
relevant on the issue of good faith but plays no role in an evaluation of reasonable basis. Simmons,
875 F.3d at 632. Respondent does not expressly contest that this petition was filed in good faith.
See, e.g., Resp’t’s Resp. Without evidence of bad faith, I find that the good faith standard is met
in this case.
b. Reasonable Basis
Even though I have determined Petitioner’s claim was filed in good faith, to receive an
award of attorneys’ fees and costs, Petitioner must also show her claim was brought with a
reasonable basis. A petitioner can receive an award of fees and costs even if her claim fails, but to
do so, she must demonstrate the claim was brought with a reasonable basis through objective
evidence supporting “the claim for which the petition was brought.” Simmons, 875 F.3d at 635;
see also Chuisano v. Sec’y of Health & Hum. Servs., 116 Fed. Cl. 276, 286 (2014) (citing
McKellar, 101 Fed. Cl. at 303). “Reasonable basis” is not explicitly defined in the Vaccine Act or
Rules. Deciding whether a claim has a reasonable basis “is within the discretion of the Special
Master . . . .” Simmons, 875 F.3d at 632 (internal citations omitted). In a reasonable basis inquiry,
a judicial officer looks not at the likelihood of success of the claim, but instead assesses the claim’s
feasibility. Perreira, 33 F.3d at 1377. Reasonable basis can be present when a case is filed and can
be lost as more information comes to light. Chuisano, 116 Fed. Cl. at 289.
A reasonable basis determination is based on a totality of the circumstances inquiry that
can be satisfied by reviewing the factual, medical, and jurisdictional support for a claim. 21 See
Cottingham v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1344–45 (Fed. Cir. 2020); Chuisano,
116 Fed. Cl. at 288. The amount of objective evidence that satisfies reasonable basis is more than
a scintilla of evidence but less than preponderant evidence. Cottingham, 971 F.3d at 1344–45
(clarifying that “the failure to consider objective evidence presented in support of a reasonable
basis for a claim would constitute an abuse of discretion.”). Thus, petitioners must offer more than
an unsupported assertion that a vaccine caused the injury alleged. See, e.g., Cortez v. Sec’y of
Health & Hum. Servs., No. 09-176V, 2014 WL 1604002, at *5 (Fed. Cl. Spec. Mstr. Mar. 26,
2014); McKellar, 101 Fed. Cl. at 303–04; Perreira, 33 F.3d at 1377.
Petitioners must “affirmatively demonstrate [the] reasonable basis” of their claim through
some objective evidentiary showing. McKellar, 101 Fed. Cl. at 305. Such a showing “must, at a
minimum, be supported by medical records or medical opinion.” Everett, 1992 WL 35863, at *2.
This means that some supporting documentation of a claim must always be offered if the claim is
to be viable. Id. Appellate authorities have held this includes the factual basis of the claim and any
medical evidence supporting that claim. See Cottingham, 971 F.3d at 1344–45; see also Chuisano,
116 Fed. Cl. at 287 (finding that “the reasonable basis inquiry is broad enough to encompass any
material submitted in support of the claim at any time in the proceeding, whether with the petition
21
The jurisdictional support for Petitioner’s claim is not at issue in this case and therefore, will not be
addressed.
14
or later.”). Indeed, a petitioner's “burden has been satisfied . . . where a petitioner has submitted a
sworn statement, medical records, and [a] VAERS report which show that recovery is feasible.”
Santacroce v. Sec'y of Health & Hum. Servs., No. 15-555V, 2018 WL 405121 at *6 (Fed. Cl.
2018). For purposes of establishing reasonable basis, medical records can support causation even
where the records provide only circumstantial evidence of causation. Cottingham, 971 F.3d at 1346
(citing Harding v. Sec’y of Dep’t of Health & Hum. Servs., 146 Fed. Cl. 381, 403 (Fed. Cl. 2019));
see also James-Cornelius v. Sec’y of Health & Hum. Servs., No. 2019-2404, 2021 WL 68806 at
*9 (Fed. Cir. Jan. 8, 2021) (finding that “the lack of an express medical opinion on causation did
not by itself negate the claim’s reasonable basis.”). After a review of the record, considering the
totality of the circumstances, I find Petitioner’s case lacked a reasonable basis at the time it was
filed.
V. Analysis
After reviewing the entire record, I find that Petitioner did not have a reasonable basis to
file this claim. As an initial matter, Petitioner attempted to demonstrate reasonable basis by arguing
that the medical literature provided to her in this case could satisfy prongs one and three of Althen.
However, Petitioner misrepresents the standard used for a determination of reasonable basis. A
finding of reasonable basis is not dependent on Petitioner’s ability to meet the entitlement standard
under Althen or Loving. That burden would undercut the ‘petitioner friendly’ nature of the Program
by discouraging counselors from taking on claims of novel nature. Indeed, in the instant case,
Petitioner voluntarily dismissed her claim based on her own belief that she could not demonstrate
causation and therefore lacked “reasonable cause to proceed further.” See Pet’r’s Mot. to Dismiss
at 2. Therefore, Petitioner’s arguments regarding her ability to meet her burden under Althen are
misplaced. Whether Petitioner’s claim had a reasonable basis from the time of filing through
dismissal will be analyzed using the applicable legal standard under Perreira, wherein the Federal
Circuit established that in a reasonable basis inquiry, the Court assesses the claim’s feasibility, not
the likelihood of success of the claim. Perreira, 33 F.3d at 1377. The Court further discussed this
standard in Cottingham and held that to meet this burden, Petitioner must present more than a mere
scintilla but less than preponderant evidence to support her claim. Cottingham, 971 F.3d at 1346.
To make a determination regarding reasonable basis, I will place Petitioner’s arguments into the
correct legal framework and analyze the factual and medical support for her claim. See id. at 1344–
45.
In support of reasonable basis, Petitioner argues her medical records show she could meet
her burden under Althen and that the flu vaccine caused the significant aggravation of her NMO.
However, I find that Petitioner’s medical records provide insufficient support for her claim that
the flu vaccine caused the significant aggravation of her NMO.
Specifically, at the time of Petitioner’s flu vaccine on October 22, 2014, she had been
receiving treatment for her NMO since January 1, 2014. It is undisputed that steroids, including
prednisone, have been proven effective at improving Petitioner’s condition. It is also undisputed
that Petitioner’s cessation of prednisone has been the direct cause of her worsening NMO
symptoms on previous occasions. For example, Petitioner’s interactions with Dr. Frost reveal that
she was “slowly improving” on a prednisone taper up until September 4, 2014, but she chose to
defer further steroid treatment after this visit. Pet’r’s Ex. 2a at 442. By October 13, 2014, Dr. Nasr
noted Petitioner’s NMO symptoms had worsened to the point that she got flexor spasms every
15
time she tried to stand. Pet’r’s Ex. 4 at 47–48. As a result, Petitioner resumed prednisone. Id.; see
also Pet’r’s Ex. 2a at 495–96. Later that day, Dr. Weinshenker discussed available treatment
options with Petitioner and recommended treating her symptoms with Rituxan, an alternative to
prednisone. Pet’r’s Ex. 4 at 52. However, prior to starting treatment with Rituxan, Dr. Weinshenker
instructed Petitioner to receive the flu vaccine. Id. To do so, he ordered Petitioner to cease taking
prednisone. Id.; see also Pet’r’s Ex. 2a at 495–96. On October 22, 2014, just prior to her receipt of
the flu vaccine, Petitioner reported to Dr. Dimaggio that she indeed stopped taking prednisone in
preparation for the vaccine, but in doing so, her NMO symptoms had worsened. Pet’r’s Ex. 2a at
495–96. Dr. Dimaggio instructed Petitioner to resume prednisone following the flu vaccine to
alleviate her worsening NMO symptoms. Id. Petitioner did so, but the worsening of her symptoms
had already progressed before the prednisone took effect. Id. at 527–29. As a result, Petitioner then
underwent an intensive, five-day course of methylprednisolone infusions and her NMO symptoms
improved. Id. at 530.
Most notably, while not a medical record, Petitioner’s evidence submitted through her own
motion to dismiss does not lend sufficient support for a finding of reasonable basis. See Chuisano,
116 Fed. Cl. at 287. Petitioner conceded that “the termination of steroid treatment five days prior
to the vaccination, had already caused a return of symptoms of her pre[-]existing disease.” Pet’r’s
Mot. to Dismiss at 2. As a result, there is insufficient evidence that Petitioner’s flu vaccine had
any impact on her NMO. Therefore, Petitioner’s evidence does not provide sufficient factual or
medical support for her claim that the flu vaccine significantly aggravated her NMO. In fact, her
evidence is contradictory.
Even if Petitioner’s treating physicians had noted a temporal association between the
vaccine and the worsening of her injury, none of Petitioner’s treating physicians attributed her
worsening NMO symptoms directly to the flu vaccine. 22 See Pet’r’s Exs. 2a–6. The lack of an
express medical opinion on causation in this case does not by itself negate my finding of reasonable
basis. See James-Cornelius, 2021 WL 68806 at *9–10. Yet, while an express medical opinion on
causation is not required in the Program, several of Petitioner’s treating physicians attributed the
worsening of her symptoms directly to her cessation of prednisone. Such attributions are relevant
to my determination of reasonable basis because they not only fail to provide support for
Petitioner’s claim, this evidence contradicts her assertion of vaccine causation. This conclusion is
further substantiated by Petitioner’s medical records in which treating physicians expressly noted
that her NMO condition deteriorated without steroids, including prednisone. As a result, they
encouraged Petitioner to remain on steroids to avoid regression. For example, in May 2017,
Petitioner stated to Dr. Weinshenker her intention to stop steroid infusions out of fear of the
negative side-effects from prolonged use. Pet’r’s Ex. 4 at 20. In response, Dr. Weinshenker
vehemently warned her that stopping such treatment would likely cause her to “relapse.” Id. He
went so far as to say Petitioner “should not interpret the fact that she was doing well as indicating
22
While none of Petitioner’s treating physicians attributed her worsening NMO symptoms to the flu
vaccine, Dr. Cox did note on October 29, 2014, that “[Petitioner] had a reaction to the pneumonia shot.”
Pet’r’s Ex. 2a at 547. However, as previously indicated, the pneumococcal vaccine is not covered by the
Vaccine Table and Petitioner conceded that the Court does not have subject matter jurisdiction over
Petitioner’s claims related to the pneumococcal vaccine. See Sched. Order at 1, ECF No. 20. Therefore, Dr.
Cox’s notation regarding the pneumococcal vaccine is immaterial to Petitioner’s claim related to the flu
vaccine causing the significant aggravation of her NMO.
16
that she was cured.” Id. at 19. It is clear that the facts of this case belie Petitioner’s significant
aggravation claim. Although medical records can support causation even where the records
provide only circumstantial evidence of the same, Petitioner’s medical records here indeed rebut
the basis for her claim. See Cottingham, 971 F.3d at 1346; Harding, 146 Fed. Cl. at 403. Therefore,
I find Petitioner’s medical records do not provide sufficient support for her claim. As Petitioner’s
claim is contradicted by her medical records and opinions from treaters, her argument in favor of
reasonable basis must fail.
Further, after Mr. McHugh took over the case, Petitioner sought the input of two experts
to provide support for her significant aggravation claim. Her efforts were unavailing. In fact,
Petitioner contends that when she sought the opinion of Dr. Shoenfeld, he provided her with
medical literature informing her that the flu vaccine could cause the significant aggravation of her
NMO. However, these articles were not filed, and Dr. Shoenfeld did not provide an opinion in
support of Petitioner’s claim, because he felt an expert in neurology was needed before he could
do so. See Pet’r’s Mot. for AFC at 3–4. Petitioner then consulted with neurologist Dr. Kinsbourne
who noted that Petitioner’s doctors “discontinued steroid treatment of her [optic neuritis] condition
on the Friday before the vaccination and as her report to her doctors indicated that deterioration of
her legs started shortly thereafter and before the vaccination.” Id. Dr. Kinsbourne continued,
“removal of steroid treatment was a non-vaccine cause which was almost as likely as the vaccine
to be responsible for her injury. Her deterioration was progressing before she was given the
vaccination.” Id. Dr. Kinsbourne does not explain what he meant by “almost as likely” or why he
came to that conclusion over its inverse. Further, he does not distinguish the role that the
pneumococcal vaccine played in Petitioner’s condition.
To establish causation in the Program, a petitioner is required to prove that the vaccine was
“not only a but-for cause of the injury but also a substantial factor in bringing about the injury.”
Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999). A showing
of but-for causation is also applicable to significant aggravation claims. If a petitioner proves a
prima facie case of causation, the burden indeed switches to respondent to establish alternate
causation. Walther v. Sec'y of Health & Hum. Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007) (noting
that “the government bears the burden of establishing alternative causation . . . once the petitioner
has established a prima facie case.”). In the context of reasonable basis, Petitioner must provide
objective medical or factual evidence to support vaccination as the but-for cause of her injury. In
this case, Dr. Kinsbourne’s preliminary statement does not provide medical support that the flu
vaccine was a substantial factor in the aggravation of Petitioner’s injury, given his concession that
the relapse in her symptoms started prior to her receipt of the vaccine. Further, because Petitioner
did not establish a prima facie case, and she conceded that she lacked “reasonable basis to proceed
further,” the burden did not shift to Respondent to demonstrate alternative causation. See Sharpe
v. Sec'y of Health & Hum. Servs., No. 14-65V, 2018 WL 7625360 (Fed. Cl. Nov. 5, 2018), aff'd,
142 Fed. Cl. 630 (2019), aff'd in part, vacated in part, remanded, 964 F.3d 1072, 1082 (Fed. Cir.
2020) (finding that “[i]n any vaccine case, if the evidence as a whole ultimately shows that the
vaccine was not a substantial factor in causing the petitioner’s injury, then compensation should
be denied.”); see also Oliver v. Sec'y of Health and Hum. Servs., No. 10-394V, 2017 WL 747846,
at *23 (Fed. Cl. Spec. Mstr. Feb. 1, 2017) (holding that assessing an off-Table significant
aggravation claim necessarily involves asking whether the individual's “clinical course and
outcome [would have been] any different than it would have been if [she] had not been
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vaccinated[.]”); Locane v. Sec'y of Health & Hum. Servs., No. 99–599V, 2011 WL 3855486, *10–
11 (Fed. Cl. Spec. Mstr. Feb. 17, 2011), aff'd, 99 Fed. Cl. 715 (Fed. Cl. 2011), aff'd, 685 F.3d 1375
(Fed. Cir. 2012) (affirming the special master's finding that petitioner's condition was not
inconsistent with the disease generally and not affected by the vaccinations). Dr. Kinsbourne’s
preliminary statement does not lend support to a burden shift because it highlighted that
Petitioner’s condition was deteriorating prior to the vaccine and it provided no explanation of how
the vaccine was a substantial factor in the worsening of her condition. See Shyface, 165 F.3d at
1352–53. In fact, Dr. Kinsbourne’s opinion merely restates what Petitioner’s medical records
already revealed and the same insurmountable hurdles to compensation remained. The preliminary
expert opinions in this matter were largely unnecessary and did not lend further support for a
finding of reasonable basis. Therefore, Petitioner is unable to offer support for her own assertion
that the flu vaccine caused the significant aggravation of her NMO. See Cortez, 2014 WL 1604002,
at *5; McKellar, 101 Fed. Cl. at 303–04; Perreira, 33 F.3d at 1377.
VI. Conclusion
I find that Petitioner has not alleged facts sufficiently supported by objective evidence to
demonstrate a reasonable basis for her claim. To support a finding of reasonable basis, Petitioner
must present more than her own assertion that a vaccine caused or significantly aggravated the
alleged injury. Petitioner’s claim is insufficiently supported by medical records or opinions. When
the complete record is considered, including Petitioner’s own statements to treating physicians,
there is insufficient evidence for a finding of reasonable basis. Therefore, I hereby DENY
Petitioner’s motion for attorneys’ fees and costs. In the absence of a motion for review filed
pursuant to RCFC Appendix B, the Clerk of Court is directed to enter judgment herewith. 23
IT IS SO ORDERED.
s/Herbrina D. Sanders
Herbrina D. Sanders
Special Master
23
Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or
jointly, filing a notice renouncing the right to seek review.
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