Court Opinion

ID: 6104219
Source: CourtListenerOpinion
Date Created: 2022-01-18 18:02:17.249629+00
Date Added: 2024-06-11T08:53:42.881223
License: Public Domain

In the United States Court of Federal Claims
                              OFFICE OF SPECIAL MASTERS
                                  Filed: December 15, 2021

* * * * * * * * * * * * * * *
R.S.,                         *                      PUBLISHED
                              *
          Petitioner,         *                      No. 15-1207V
                              *
v.                            *                      Special Master Nora Beth Dorsey
                              *
SECRETARY OF HEALTH           *                      Motion for Relief from Judgment; Vaccine
AND HUMAN SERVICES,           *                      Rule 36; RCFC 60(b); Influenza (“Flu”)
                              *                      Vaccine; Guillain-Barré Syndrome (“GBS”);
          Respondent.         *                      Polyneuropathy, Organomegaly,
                              *                      Endocrinopathy, Monoclonal
                              *                      Gammopathy, and Skin Changes
                              *                      (“POEMS”) Syndrome.
* * * * * * * * * * * * * * *

Ronald C. Homer, Conway, Homer, P.C., Boston, MA, for petitioner.
Alexa Roggenkamp, U.S. Department of Justice, Washington, DC, for respondent.

                    ORDER ON REMAND DENYING PETITIONER’S
                     MOTION FOR RELIEF FROM JUDGMENT 1

I.     INTRODUCTION

       On October 15, 2015, R.S. (“R.S.” or “petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2012), 2 alleging that as a result of receiving an influenza (“flu”)
vaccine on October 1, 2013, she suffered from Guillain-Barré syndrome (“GBS”) and
polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes
(“POEMS”) syndrome. Petition at 1-2 (ECF No. 1). On December 19, 2019, the undersigned

1
  When the decision denying entitlement was originally issued, the undersigned advised her
intent to post it 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). In accordance with Vaccine Rule 18(b), petitioner filed a
timely motion to redact certain information. The decision was reissued with initials, R.S. or S.,
in place of petitioner’s name.
2
 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Order to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.
issued a decision denying entitlement. Decision dated Dec. 19, 2019 (ECF No. 136).
Subsequently, petitioner sought review of the decision. Motion for Review, filed Jan. 21, 2020
(ECF No. 144). Judge Ryan T. Holte denied petitioner’s motion for review. Opinion and Order
dated June 19, 2020 (ECF No. 157). Judgment entered on June 19, 2020, dismissing the petition.
Judgment dated June 19, 2020 (ECF No. 158).

        Petitioner filed her present motion for relief from judgment on June 21, 2021, requesting
that “her case be reopened in order to file additional medical records and medical expert opinion
based on [her] recent medical course.” Petitioner’s Motion for Relief from Judgment (“Pet.
Mot.”), filed June 21, 2021, at 5 (ECF No. 165). Petitioner received a flu vaccine on November
8, 2020. 3 Id. at 2. She alleges that approximately two weeks later, “she developed the onset of
bilateral leg weakness and numbness.” Id. at 7. Petitioner asserts that this event represented a
“rechallenge episode” that “constitutes persuasive evidence” of the causal role of her 2013 flu
vaccination. Id. Further, petitioner contends that these events constitute “newly discovered
evidence,” providing the basis for her motion pursuant to RCFC 60(b)(2). Id. “To the extent
that this Court finds [RCFC] 60(b)(6) to be more suitable grounds for reopening judgment,” the
petitioner incorporates RCFC 60(b)(6) as a basis for her motion. Pet. Reply to Respondent’s
Response (“Pet. Reply”), filed July 8, 2021, at 5 (ECF No. 170).

        Respondent argues petitioner has not met the requirements of RCFC 60(b)(2) or 60(b)(6).
Respondent’s Memorandum in Response to Pet. Mot. (“Resp. Response”), filed July 1, 2021, at
8-13, 13 n.7 (ECF No. 167); Resp. Sur-Reply in Support of Resp. Response (“Resp. Sur-Reply”),
filed July 28, 2021, at 4 n.1, 4-10 (ECF No. 173).

        Under Vaccine Rule 36(a)(1), the present motion was before Judge Holte. However, on
November 9, 2021, Judge Holte remanded the motion to the undersigned due to the significant
fact-finding that would be required to decide if petitioner is entitled to the relief sought. Order
dated Nov. 9, 2021, at 2 (ECF No. 174).

        After carefully analyzing and weighing the applicable rules, case law, and evidence
presented, in accordance with the applicable legal standards, the undersigned finds that petitioner
has failed to establish that she is entitled to relief from judgment. Therefore, petitioner’s motion
is DENIED.

II.    PROCEDURAL HISTORY

       The petition was filed in this matter on October 15, 2015, and subsequently, petitioner
filed medical records and supporting affidavits. Pet. Exhibits (“Exs.”) 1-23. On February 22,
2016, respondent filed his Rule 4(c) Report, recommending against compensation. Resp. Report
(“Rept.”) at 2.

      On August 5, 2016, petitioner filed an expert report by Dr. Norman Latov. Pet. Ex. 29.
Respondent thereafter filed a responsive expert report by Dr. Dennis Bourdette on January 6,
3
 Petitioner’s motion indicated petitioner received the flu vaccine at issue on November 7, 2020;
however, records indicate the vaccine was administered on November 8, 2020. See Pet. Mot. at
2; Pet. Ex. 88 at 1.

                                                 2
2017. Resp. Ex. A. On January 26, 2017, the undersigned ordered petitioner to file a
supplemental expert report addressing the opinions of Dr. Bourdette. Order dated Jan. 26, 2017
(ECF No. 34). Petitioner submitted a supplemental report from Dr. Latov on March 27, 2017.
Pet. Ex. 31.

        On May 2, 2017, the undersigned held a Rule 5 status conference with the parties. Order
dated May 2, 2017 (ECF No. 39). Given the complexities of the case, the undersigned did not
offer her preliminary findings. Id. at 1. Rather, both parties agreed that expert reports
addressing the hematologic aspect of petitioner’s claim would be helpful. Id.

        Respondent filed an expert report by Dr. Brea Lipe on June 16, 2017. Resp. Ex. C. On
December 4, 2017, petitioner submitted a responsive report from Dr. Latov. Pet. Ex. 38.
Petitioner filed an expert report from Dr. Samir Parekh on October 11, 2018. Pet. Ex. 57.

        An entitlement hearing was held on January 29-30, 2019. The parties filed post-hearing
briefs on April 26, 2019 and July 24, 2019, respectively. Pet. Post-Hearing Submission, filed
Apr. 26, 2019 (ECF No. 121); Resp. Post-Hearing Submission, filed July 24, 2019 (ECF No.
134). The undersigned issued a decision on December 19, 2019 dismissing petitioner’s case.
Decision dated Dec. 19, 2019. Petitioner filed a motion for review on January 21, 2020, which
was denied by Judge Holte on June 19, 2020, and judgment entered that day. Opinion and
Order; Judgment.

         On June 21, 2021, petitioner filed the present motion for relief from judgment pursuant to
Vaccine Rule 36 and RCFC 60(b). Pet. Mot. at 3. The motion has been fully briefed by the
parties.

        On November 9, 2021, Judge Holte remanded the present motion to the undersigned.
Order dated Nov. 9, 2021. Judge Holte explained that “[t]he Court ‘issue[s] its own findings of
fact’ when it is setting aside the Special Master’s findings of fact.” Id. at 2 (quoting §
12(e)(2)(B)). After a review of petitioner’s motion and various filings, he determined that
“significant fact-finding would be required to decide if [petitioner] is entitled to relief, and
because “the Special Master has not yet made any findings of fact regarding the new evidence
presented by petitioner,” the case was remanded. Id.

       This matter is now ripe for adjudication.

III.   FACTUAL SUMMARY 4

       A.      Medical History Prior to Vaccination in 2013

        R.S. was born on August 23, 1972. Pet. Ex. 3 at 35. Prior to her receipt of the vaccine at
issue in this matter, R.S. had no history of neurological abnormalities. Her prior medical history
is significant for cherry angiomas, basal cell neoplasms, and depression. Pet. Ex. 2 at 1; Pet. Ex.
3 at 35-36.
4
 Sections A and B of the factual summary are largely taken from the undersigned’s dismissal
decision. See Decision at 4-9.

                                                   3
       B.      Receipt of Vaccination in 2013 and Subsequent Clinical Course

               1.      Medical Treatment in 2013

       R.S. received a flu vaccine on October 1, 2013. Pet. Ex. 1 at 1. No adverse reaction was
noted at the time of vaccine administration. Id.

       On November 6, 2013, roughly four weeks following her vaccination, R.S. presented to
Dr. Gopalan Umashankar, a neurologist employed with Cottage Hospital in Woodsville, New
Hampshire. Pet. Ex. 6 at 1-2. R.S. complained of weakness and numbness in her legs. Id. at 1.
She reported to Dr. Umashankar that three days following her receipt of the flu vaccine, she
experienced severe diarrhea and stomach pain that lasted a couple of days. Id. Around October
10, 2013, R.S. reported that she developed numbness in the tips of her toes, which eventually
ascended to the pads of her feet and toes. Id.

        At the time of her visit with Dr. Umashankar, petitioner’s symptoms had progressed over
the past week to include pain in the calves and hips, fatigue, palpitations, numbness in the
fingers, unsteady gait, and drooling. Pet. Ex. 6 at 1. Upon examination, petitioner’s dorsiflexors
were noted to be weak, and reflexes in her ankles, biceps, and knees were diminished. Id. at 2.
A mid-shin sensory deficit was also noted. Id. Dr. Umashankar assessed R.S. with “probabl[e]”
GBS 5 due to the markedly diminished reflexes, sensory deficits, and facial involvement, though
it was noted that additional testing would be needed to confirm the diagnosis. Id. R.S. was
admitted to Dartmouth Hitchcock Medical Center (“Dartmouth”) that same day for further
testing. Id.

         Upon admission to Dartmouth, R.S. was seen by a second neurologist, Dr. Elijah
Stommel. Pet. Ex. 7 at 1-6. Consistent with the history provided to Dr. Umashankar, R.S.
reported that she developed a “GI bug” three days following her receipt of the flu vaccine on
October 1, 2013. Id. at 1. By mid-October of that year, she developed toe and finger numbness,
calf pain, weakness in the lower extremities, low back pain, palpitations, drooling, and eye strain.
Id. at 1-2. Dr. Stommel reviewed R.S.’s history and opined that her course was “concerning for
acute inflammatory demyelinating polyneuropathy” or AIDP. Id. at 6. Dr. Stommel further
noted the viral illness reported prior to the onset of symptoms which would be consistent with
such a diagnosis. Id. A lumbar puncture conducted during R.S.’s hospital stay showed a slightly
elevated protein of 57 (range: 15-45) with normal glucose. Id. at 44. An electromyography
(“EMG”) was consistent with a generalized peripheral neuropathy with demyelinating features.
Id. at 56. R.S.’s lab tests also indicated that she had thrombocytosis, with an elevated platelet
count of 473 x10(3)/mcL. Id. at 4. Her immunoglobulin A (“IgA”) level was within normal
limits at 174 (range: 70-400mg/dL). Id. at 5. R.S. was discharged on November 11, 2013, with
diagnoses of GBS and AIDP. Id. at 54. Discharge notes indicated that she received a dose of
Solu-medrol (200mg) and a five-day course of IVIG treatment with noted improvement in
extremity strength. Id. at 54-58.

5
 GBS is a peripheral neuropathy involving rapidly-progressive and ascending motor paralysis
caused by demyelination of the peripheral nerves. See Pet. Ex. 29, Tab C at S21-S22.

                                                 4
        R.S. was hospitalized a second time at Littleton Regional Healthcare (“Littleton
Regional”) in Littleton, New Hampshire from November 26-29, 2013 due to difficulties with her
speech and gait. Pet. Ex. 5 at 658-59. Upon admission, R.S. reported that she did well over a
two-week period, but started to experience increased tingling in the legs and fingers, difficulty
walking, chest pain, and voice issues, roughly 36 hours prior to presentation. Id. at 658. It was
noted that she received a flu vaccine in early October. Id. at 658-59. Emergency room treaters
assessed her with a GBS flare and recommended further treatment with IVIG. Id. at 659. Her
thrombocytosis persisted, with labs indicating her platelets remained elevated at 707 K/uL. Id. at
628. On November 27, 2013, Dr. Stephen Goldberg conducted a serum protein electrophoresis
(“SPEP”) test without immunofixation (“IFE”) to test for monoclonal gammopathy. Pet. Ex. 7 at
600. R.S. tested negative for the monoclonal protein, but two beta region peaks were recorded.
Id. The assessment remained GBS with treatment related fluctuation. Pet. Ex. 5 at 681.
Discharge records indicated that R.S.’s paresthesia and gait improved following IVIG treatment.
Id. Her deep tendon reflexes remained absent, and she continued to experience residual tingling
in the toes. Id.

        R.S.’s health continued to worsen. Less than two weeks later, she was readmitted to
Littleton Regional on December 10, 2013 for persistent lower extremity weakness, sensory loss,
and paralysis in the lower extremities. Pet. Ex. 5 at 544; Pet. Ex. 7 at 324-26. Upon admission,
petitioner complained of worsening paresthesia, continued gait abnormalities, and leg pain. Pet.
Ex. 5 at 485-87. R.S. received two additional infusions of IVIG at Littleton Regional, with no
improvement in strength. Pet. Ex. 7 at 314-16. She was transferred back to Dartmouth on
December 12, 2013 for further evaluation and treatment. Id. She finished her five-day course of
IVIG at Dartmouth with a steady improvement in strength noted following her last treatment. Id.
at 342. R.S. was discharged on December 15, 2013, with instructions to follow up with her
primary neurologist as needed. Id. at 325.

        On December 20, 2013, petitioner presented for a follow-up appointment with Dr.
Stommel. Pet. Ex. 7 at 471-72. Petitioner reported that she continued to experience weakness,
but could ambulate well with a walker. Id. On examination, Dr. Stommel noted residual
complaints, including sensory loss in the lower extremities, weakness in both legs, and subtle
weakness in the biceps. Id. at 471. A repeat nerve conduction study (“NCS”) revealed a slight
worsening in active denervation in the left tibialis. Id. Given the progression of her symptoms,
Dr. Stommel recommended that she continue IVIG treatments. Id. Dr. Stommel also prescribed
Cellcept. Id. Lab testing conducted on December 26, 2013, and January 15, 2014, indicated that
R.S.’s thrombocytosis remained persistent with elevated platelet levels of 554 k/uL and 583
k/uL, respectively. Id. at 477, 484. R.S. remained relatively stable throughout the remainder of
2013, though she continued to complain of tremors, foot pain, blurred vision, fatigue, weakness,
and diminished sensation in the lower extremities. Pet. Ex. 7 at 478-79.

               2.     Medical Treatment in 2014

        R.S. presented to Littleton Regional for a fourth hospitalization on January 27, 2014. Pet.
Ex. 5 at 63-65, 379. The history recorded at discharge indicated that she was diagnosed with
GBS initially on November 6, 2013, and suffered three relapses all of which required IVIG
treatment. Id. at 63. Upon admission, R.S. complained of cognitive issues, fever, and chills. Id.

                                                5
at 63-64. She also had “trouble remembering things.” Id. at 64. The attending physician
diagnosed R.S. with aseptic meningitis secondary to an IVIG infusion she received on January
23, 2014. Id. at 69. An MRI of the thoracic spine showed a spinal cord neoplasm at the T12-L1
level. Id. at 379. The attending neurologist opined that the neoplasm was likely incidental and
not related to petitioner’s paresthesia, which he deemed to be related to a chronic inflammatory
demyelinating polyneuropathy (“CIDP”) 6 diagnosis. Id. at 64.

        On February 4, 2014, petitioner presented to the Massachusetts General Hospital
(“MGH”) neuromuscular clinic for an evaluation of her persistent symptoms. Pet. Ex. 8 at 26-
30. The health history recorded during this visit indicated that R.S.’s symptoms began with
progressive lower limb weakness in October 2013 and thereafter progressed to include severe
fatigue, calf pain, gait abnormalities, and sensory deficits. Id. at 26-29. The attending physician,
Dr. Michael Bowley conducted a repeat EMG/NCS, both of which continued to show evidence
of sensory and motor polyneuropathy. Id. at 8-10. Dr. Bowley concluded that R.S. likely had
CIDP, with multiple subsequent relapses, given her clinical history of rapidly evolving motor
deficits, distal areflexia, and elevated cerebrospinal fluid. Id. at 28. R.S.’s “initial improvement”
with IVIG was also considered to be supportive of such a diagnosis; however, Dr. Bowley
indicated that her repeated relapses did not respond as well to further IVIG treatment. Id. Dr.
Bowley recommended that she increase her mycophenolate dose and use corticosteroids as
needed. Id. at 29. Her platelet count remained elevated at 627 k/uL. Pet. Ex. 9 at 131. A SPEP
test conducted on February 4, 2014, showed an abnormal pattern of two IgA lambda components
at 0.22 and 0.06 g/dL in the beta region, but was negative for monoclonal protein. Pet. Ex. 8 at
3-4.

        Petitioner was hospitalized for a thoracic laminectomy and mass resection on February
12, 2014, both of which were unrelated to her underlying disease course. Pet. Ex. 9 at 25, 127-
28. Prior to the surgery, her treaters discovered a spinal mass and recommended removal out of
concern for lymphoma. Id. at 116-19. Pathologic testing indicated that the mass was a T12
hemangioma. Id. On February 18, 2014, R.S. was transferred to a rehabilitation facility for
occupational and physical therapy. Pet. Ex. 10 at 36-39. Upon discharge on March 14, 2014,
petitioner could ambulate and transfer with a walker. Id. at 38. Her discharge diagnoses
included extradural spinal mass and post-T12 laminectomy, with a secondary diagnosis of
GBS/CIDP. Id. at 32.

        On May 27, 2014, R.S. presented for a follow-up appointment at MGH with Dr. Jennifer
Dineen. Pet. Ex. 8 at 14-18. She reported that she continued to experience fatigue, weakness in
her legs, tremors, nerve pain, gait abnormalities, and blurry vision. Id. at 15-16. Her exam
revealed a sensory and motor neuropathy with features indicative of a demyelinating
polyneuropathy. Id. at 15. Dr. Dineen recommended that R.S. continue Cellcept and maintain
Gabapentin as needed. Id. at 18. She also decreased petitioner’s Prednisone dosage to 30mg
daily. Id. Dr. Dineen did not think that further IVIG treatment would be helpful at this time. Id.

6
 CIDP is a chronic form of GBS, which progresses slowly over time, but manifests similar
symptoms. Resp. Ex. E, Tab 1 at 477.

                                                 6
               3.      POEMS Diagnosis and Treatment in July and August 2014

        R.S. presented to Littleton Regional on July 14, 2014, with complaints of postural
headaches, diplopia, incontinence, and cognitive issues. Pet. Ex. 22 at 194. Upon admission,
petitioner was evaluated by Dr. Umashankar in the emergency room. Id. A lumbar puncture
revealed an elevated opening pressure with no white blood cells detected, and a normal total
protein at 38 mg/dl. Id. at 195. A brain MRI conducted during the visit was also normal. Id.
Given the above, R.S.’s treaters felt her symptoms were consistent with benign intracranial
hypertension. Id. Prior to her discharge, R.S. was also evaluated by an ophthalmologist, Dr.
Krista Haight, for complaints associated with eye pressure, pain, and hazy vision. Pet. Ex. 53 at
1. Dr. Haight assessed petitioner with papilledema. Id. at 3.

        From July 31 to August 5, 2014, R.S. presented to MGH for complaints related to
persistent headaches and vision changes. Pet. Ex. 18 at 1232. Upon admission, R.S. was
evaluated by a neurologist, Dr. Mingming Ning. Id. Cerebrospinal fluid testing was
unrevealing. Id. Intake notes indicated that R.S. had symptoms of CIDP-like neuropathy,
thrombocytosis, and papilledema. Id. Dr. Ning suspected that R.S. might have POEMS 7
syndrome and recommended a hematology consult. Id. A SPEP draw with immunofixation,
conducted on August 1, 2014, revealed a persistent IgA lambda monoclonal protein with
components at 0.15 and 0.06 g/dl. Id. at 1163, 1165. The free light chain evaluation showed
normal kappa levels, and elevated lambda at 31, which was considered to be within a normal
ratio limit. Id. at 1163. It was also noted that R.S. had possible sclerotic lesions in the mandible
and right pelvis following a skeletal survey, though a bone scan showed no definitive sclerotic
lesions. Id.

        R.S. returned to MGH on August 12, 2014. Pet. Ex. 18 at 441, 1152. Upon admission,
she complained of lethargy, reduced appetite, and blurry vision. Id. She also reported that her
symptoms of weakness remained stable, though she had lost movement in her right toe. Id. at
441, 1167. Treaters questioned the need to continue Cellcept and Prednisone in light of the
alternative treatment plan for suspected POEMS syndrome. Id. at 1086. Petitioner was
evaluated by the attending hematologist, Dr. Annemarie Fogerty, on August 13, 2014. Id. at
1163. Dr. Fogerty assessed petitioner with a progressive neuropathy, dual M-spike, and
thrombocytosis, concerning for POEMS syndrome. Id. It was noted that petitioner satisfied the
two major criteria for the condition (i.e., neuropathy and monoclonal gammopathy), as well as
two minor criteria: papilledema and thrombocytosis. Id. Petitioner’s vascular endothelial
growth factor (“VEGF”) 8 levels, taken on August 14, 2014, were noted to be elevated at 1799
(reference range: 31-86), and the diagnosis of POEMS syndrome was confirmed. Id. at 444, 446.

7
 POEMS syndrome is a paraneoplastic syndrome due to an underlying plasma cell disorder.
Pet. Ex. 29, Tab F at 214.
8
 VEGF levels are elevated in patients diagnosed with POEMS syndrome. Pet. Ex. 29, Tab F at
215. VEGF is known to target endothelial cells and induce a rapid and reversible increase in
vascular permeability. Id. It is expressed by osteoblasts in bone tissue, macrophages, tumor
cells, including plasma cells, and megakaryocyte/platelets. Id.

                                                 7
        Prior to her discharge on August 18, 2014, petitioner was evaluated by another
hematologist, Dr. Andrew Yee. Pet. Ex. 18 at 1082. Dr. Yee discussed POEMS syndrome with
R.S. and explained her course in light of the accepted diagnostic criteria. Id. In his opinion,
multiple clinical factors identified in R.S.’s prior history, including polyneuropathy, IgA lambda
gammopathy, markedly elevated VEGF levels, thrombocytosis, and papilledema, supported a
POEMS diagnosis. Id. Dr. Yee also discussed treatment options with R.S., including a stem cell
transplant. Id. Petitioner’s records reveal that Dr. Yee recommended Revlimid and
dexamethasone for her POEMS-related symptoms. Id.

               4.     Medical Care in 2015

       R.S. underwent an autologous stem cell transplant on January 29, 2015. Pet. Ex. 18 at
385-93. Of note, her VEGF levels improved with treatment. Id. at 386. R.S.’s platelets also
returned to normal. Pet. Ex. 19 at 1, 28.

        On June 17, 2015, R.S. presented to Dr. Angela Dispenzieri, a hematologist at the Mayo
Clinic, for a second opinion regarding her POEMS diagnosis. Pet. Ex. 19 at 27. Dr. Dispenzieri
noted that petitioner had been diagnosed with POEMS in August 2014 based on a set of factors,
including: demyelinating peripheral neuropathy, IgA lambda monoclonal protein, hypertrichosis,
white nails, papilledema, peripheral edema, and thrombocytosis. Id. Dr. Dispenzieri placed the
onset of petitioner’s illness in October 2013, when she experienced new onset fatigue and
numbness/tingling in the feet, along with eruptions of cherry angiomas on the skin. Id. By
October/November 2013, her symptoms progressed to include muscle pain, difficulty walking,
ascending hip pain, numbness in the fingers, and slight drooling. Id. Her initial hospitalization
in November 2013 for presumed GBS/CIDP was noted, along with her initial marked
improvement with IVIG treatment. Id.

        Following her initial hospitalization, Dr. Dispenzieri noted that R.S.’s course worsened.
Pet. Ex. 19 at 27. Additional treatment with IVIG, Cellcept, and Prednisone through 2014 did
not result in similar levels of improvement. Id. Following her POEMS diagnosis, R.S. started
treatment with Revlimid and dexamethasone between September 2014 and December 2014,
which resulted in a significant decrease in the serum VEGF, but only marginal improvement in
her lower extremity neuropathy symptoms. Id. at 28. Further treatment with cyclophosphamide
mobilization, high-dose melphalan, and stem cell infusion resulted in good improvement. Id.
All in all, Dr. Dispenzieri opined R.S.’s course was consistent with POEMS syndrome. Id. at 30.

        As of May 2015, R.S. continued to be treated for POEMS. Pet. Ex. 18 at 562. She
routinely experienced fatigue, intermittent headaches, hot flashes, foot swelling and discomfort,
and diminished strength in both feet. Id. at 563-64. A neurological exam conducted on May 29,
2015 showed normal function apart from marked weakness and sensory loss in the lower limbs.
Id. at 565. Her gait was also improved. Id.

       C.      Summary of Medical Records Filed in Support of Petitioner’s Motion

       In support of her current Motion, petitioner filed medical records documenting her flu
vaccination on November 8, 2020, which is at issue here, as well as records from Littleton

                                                8
Regional, Littleton Regional Primary Care Physicians, and the Mayo Clinic. See Pet. Exs. 88-
91. 9 These records document petitioner’s past history as well as her clinical course from 2018
until January 2021. 10

        On October 1, 2015, petitioner received a flu vaccine. Pet. Ex. 91 at 5, 682. No adverse
reaction was noted.

        From May to July 2018, petitioner had a “[p]ossible relapse [of her POEMS] with
papilledema, edema, hemangiomata, and [] nausea.” Pet. Ex. 91 at 110. She was treated with
Revlimid and dexamethasone. Id.

        On November 29, 2018, petitioner presented to the Emergency Department (“ED”) of
Littleton Regional with complaints of chest pain. Pet. Ex. 89 at 68. The immunization record
from this visit documents that petitioner received a flu vaccine in 2017. Id. at 71. There is no
documentation suggesting that petitioner experienced any adverse reaction to the vaccination.

        Petitioner presented to the Littleton Regional ED on December 19, 2018 for a headache
that was not responsive to medications. Pet. Ex. 89 at 64. Petitioner reported that her headaches
were usually caused by increased intracranial pressure. Id. She reported a “history of cancer
with [POEMS] syndrome and . . . an episodic rise in intracranial pressure.” Id. Petitioner
underwent a therapeutic lumbar puncture, which relieved her symptoms. Id. The records
document that petitioner received flu vaccines in 2017 and 2018. Id. at 66. No adverse reaction
to these vaccinations was noted.

        On December 28, 2018, petitioner spoke with her hematologist, Dr. Dispenzieri, by
telephone, about needing a lumbar puncture to treat her increased intracranial pressure. Pet. Ex.
91 at 643. Dr. Dispenzieri was not sure whether petitioner’s increased intracranial pressure was
due to POEMS. Id.

        Petitioner underwent a brain MRI on January 9, 2019, which showed several new
enhancing lesions. Pet. Ex. 91 at 427-28. Dr. Dispenzieri referred petitioner to Dr. Scott Eggers
for an evaluation of her abnormal MRI. Id. at 427. Dr. Eggers reviewed petitioner’s “complex
history of POEMS syndrome and raised intracranial pressure with papilledema that ha[d]
required ventriculoperitoneal shunting.” Id. Physical examination revealed petitioner had a
“bilateral steppage gait, [and was] unable to rise on heels and barely on toes.” Id. at 429. She
had “[m]oderate to severe symmetric weakness below the knees with very mild bilateral
quadriceps and hamstring weakness.” Id. Dr. Eggers concluded that clinically, petitioner
appeared stable. Id.

      On February 4, 2019, petitioner returned to see Dr. Dispenzieri, complaining of a
“complete lack of energy” and pain. Pet. Ex. 91 at 541. Dr. Dispenzieri noted that petitioner’s
9
  The undersigned has reviewed all of the records and documents filed, but only references those
that are relevant to her present Order.
10
  The records that have been filed in support of petitioner’s motion do not appear to be
complete. However, they are sufficient for purposes of evaluating petitioner’s present Motion.

                                                 9
pain in feet and headache associated with increased intracranial pressure were previously signs
of relapse (in July 2018). Id. Dr. Dispenzieri diagnosed petitioner with “POEMS syndrome,
relapsed disease.” Id. at 547.

        Moving forward, petitioner saw Dr. Dispenzieri on September 3, 2020, complaining of a
“[c]omplete lack of physical energy,” depression, anxiety, and nausea. Pet. Ex. 91 at 111. She
reported falling “several times per week.” Id. Her neuropathy was unchanged. Id. Dr.
Dispenzieri did not think that petitioner was having a relapse, and was unsure whether
petitioner’s symptoms were related to POEMS. Id. at 118.

         The following day, September 4, 2020, petitioner had an appointment with neurologist
Dr. Jennifer Martinez-Thompson for peripheral neuropathy. 11 Pet. Ex. 91 at 58. EMG/NCS
done September 3, 2020 showed “severe length-dependent mixed axonal demyelinating
sensorimotor peripheral neuropathy.” Id. at 59. Compared to a prior EMG performed in July
2016, there was some improvement. Id. Petitioner reported that her weakness had improved,
she still had mild foot drop, but was able to walk independently. Id. She sometimes used a cane
for walking long distances. Id. Her numbness had also improved, although she continued to
have numbness to above the knees. Id. Also, petitioner complained of “burning, tingling,
pricking sensation[s] in her shins.” Id. at 61. This neuropathic pain was “very disturbing . . . and
limiting most of her daily activities.” Id.

         Review of symptoms was “[p]ositive for numbness or shooting pain in hands, arms, legs,
or feet, loss of balance or tendency to fall easily, headaches and weakness in arms or legs.” Pet.
Ex. 91 at 61. Physical examination revealed “significant weakness in distal lower extremities
(slight improvement in plantarflexion and eversion compared to last visit).” Id. at 61-62.
Decreased sensation was noted above the knee level. Id. at 62. Petitioner had hyperalgesia and
allodynia in both feet. Id. Reflexes were -2 at the knees but absent at the ankles. Id. Petitioner
was unable to walk or stand on her heels. Id. The neurology fellow, Dr. Pitcha Chompoopong,
concluded that petitioner’s “POEMS seem[ed] to be in remission” and that her distal lower limb
pain was likely neuropathic. Id.

        A health questionnaire completed on November 4, 2020, documented that petitioner was
having “numbness or shooting pain in hands, arms, legs[,] or feet;” “[w]eakness in arms and/or
legs;” and “[l]oss of balance or tendency to fall easily.” Pet. Ex. 91 at 93.

       Petitioner received the flu vaccine at issue on November 8, 2020. Pet. Ex. 88 at 1.

       On December 12, 2020, petitioner presented to the ED at Littleton Regional. Pet. Ex. 89
at 53. Dr. Richard M. Levitan stated that petitioner was “referred by neurology for admission for
IVIG; complaining of weakness and pain in lower legs.” Id. Petitioner reported that she had
“chronic weakness in her lower legs, but feels more weak than usual.” Id. She also reported
having more pain than usual, and that her neurologist was concerned that she was “having a
recurrence of [GBS].” Id. Dr. Levitan’s physical examination revealed “[d]iscomfort with
11
  Petitioner left for another appointment before she was seen by Dr. Martinez-Thompson, and
therefore, Dr. Martinez-Thompson relied on the clinical notes and physical findings of Dr. Pitcha
Chompoopong, a neurology fellow, who saw petitioner that day. Pet. Ex. 91 at 58, 60, 676.

                                                10
palpation diffusely below the knees bilaterally” and good range of motion. Id. at 55. Petitioner
was “able to lift [her] legs off the bed, [but could not] toe walk.” Id. She had “[g]ood strength in
her upper extremities.” Id. Labs indicated that petitioner’s “inflammatory makers [were]
normal.” Id. at 57. Dr. Levitan’s clinical impression was polyneuropathy, POEMS. Id.

         On admission to the hospital, history and physical examination were performed by Dr.
Stephen Goldberg. Pet. Ex. 89 at 41. Chief complaint was weakness. Id. In history of present
illness, Dr. Goldberg documented that petitioner had a flu shot five weeks before admission. Id.
Petitioner reported that two-and-one-half weeks prior, she had become weaker, and over the last
few days, she had difficulty walking. Id. A lumbar puncture performed the day before showed
mildly elevated protein. Id. Petitioner reported paresthesias in her arms. Id. at 45. Leg strength
was assessed as 1-2 out of 5. Id. Petitioner was admitted for IVIG treatment. Id. at 49. She
received six treatments of IVIG, and was discharged on December 17, 2020. Id. at 18.

        On January 4, 2021, petitioner was seen for follow up after her hospital discharge by her
neurologist, Dr. Umashankar. Pet. Ex. 90 at 1. She complained of fatigue and pain and “felt that
she needed another round of IVIG infusion.” Id. Petitioner’s husband, a physician, “[felt] that
this [was] myalgia encephalitis syndrome or chronic fatigue syndrome.” Id. Muscle strength
was 5/5 in the lower limbs, except for bilateral tibialis anterior, which was 2-3/5, and extensor
hallucis longus, which was 1-2/5. Id. at 4. Petitioner was able to walk without assistance. Id.
Dr. Umashankar’ s diagnoses were POEMS syndrome and polyneuropathy. Id. He noted that
“[i]nterestingly[,] she had a flu shot about 2 weeks before the onset of symptoms in December
2020.” Id. He wrote, “I am honestly stumped if this was worsening of her neuropathy of
POEMS syndrome or if this was [GBS].” Id. Dr. Umashankar referred petitioner to the MGH
neuromuscular team for a second opinion. Id.

        Several weeks later, on January 26, 2021, petitioner returned to Littleton Regional with
“progressive distal extremity numbness and weakness over the past week or so. She [was]
confined to a walker as her lower extremities [were] unable to feel and move.” Pet. Ex. 89 at 33.
Petitioner also reported a day of right ear pain. Id. Admitting diagnoses were “[f]lare of
POEMS disease, chronic pain, chronic anxiety.” Id. at 1. Petitioner was discharged on January
30, 2021, after receiving IVIG with good results. Id. “Her neurological status improved back to
near baseline” and she was able to walk without assistance. Id. at 1-2. She was discharged home
and instructed to follow up with neurology and MGH neuromuscular neurology. Id. at 2, 6.

IV.    APPLICABLE LEGAL STANDARDS

        Vaccine Rule 36(a) allows a party to seek relief from judgment pursuant to RCFC 60. In
determining whether a judgment should be set aside or altered, “the need for finality of
judgments” must be balanced against “the importance of ensuring that litigants have a full and
fair opportunity to litigate.” Kennedy v. Sec’y of Health & Hum. Servs., 99 Fed. Cl. 535, 539
(2011) (citing United Student Aid Funds, Inc. v. Espinosa, 559 U.S. 260, 276 (2010)); see also
Bridgham ex rel. Libby v. Sec’y of Health & Hum. Servs., 33 Fed. Cl. 101, 104 (1995)
(discussing the “tension between the goals of ensuring that the court’s judgment appropriately
reflects the adjudication of the parties’ rights and of providing the parties with certainty as to
those rights”).

                                                11
        “The court has discretion regarding whether to grant relief under [RCFC] 60(b), ‘and the
court may weigh equitable considerations in the exercise of its discretion.’” Curtis v. United
States, 61 Fed. Cl. 511, 512 (2004) (quoting Dynacs Eng’g Co. v. United States, 48 Fed. Cl. 240,
241-42 (2000)). RCFC 60(b) as a remedial provision is to be “liberally construed for the purpose
of doing substantial justice.” Patton v. Sec’y of Health & Hum. Servs., 25 F.3d 1021, 1030 (Fed.
Cir. 1994).

      Under RCFC 60(b), the court may grant relief from a final judgment on the following
grounds:

       (1) mistake, inadvertence, surprise, or excusable neglect;
       (2) newly discovered evidence that, with reasonable diligence, could not have
       been discovered in time to move for a new trial under RCFC 59(b);
       (3) fraud . . . , misrepresentation, or misconduct by an opposing party;
       (4) the judgment is void;
       (5) the judgment has been satisfied, released, or discharged; it is based on an
       earlier judgment that has been reversed or vacated; or applying it prospectively is
       no longer equitable; or
       (6) any other reason that justifies relief.

RCFC 60(b).

        Motions for relief under RCFC 60(b) “seek . . . to set aside a final decision and it is
incumbent upon the motion-filer to demonstrate that [s]he . . . is entitled to relief.” Kennedy, 99
Fed. Cl. at 550. The motion’s statements are “not like a pleading . . . in which the factual
allegation[s] are presumed true.” Id.

        As a threshold matter, RCFC 60(c)(1) requires that “[a] motion under RCFC 60(b) must
be made within a reasonable time—and for reasons (1), (2), and (3), no more than a year after the
entry of the judgment or order or the date of the proceeding.” RCFC 60(c)(1). Any motion
seeking relief under RCFC 60(b)(1) that is filed after the one-year mark is completely barred.
See United States v. Berenguer, 821 F.2d 19 (1st Cir. 1987); Freeman v. Sec’y of Health & Hum.
Servs., 35 Fed. Cl. 280, 283 (1996); Kenzora v. Sec’y of Health & Hum. Servs., No. 10-669V,
2015 WL 6121582, at *2 (Fed. Cl. Spec. Mstr. Sept. 25, 2015).

        RCFC 60(b)(2) provides that “the court may relieve a party . . . from a final judgment,
order, or proceeding” if there is “newly discovered evidence that, with reasonable diligence,
could not have been discovered in time to move for a new trial under [RCFC] 59(b).” Under this
rule, the moving party must show the proffered evidence is (1) newly discovered and (2)
material. Mark Dunning Indus., Inc. v. United States, 143 Fed. Cl. 735, 738 (2019).

       Under RCFC 60(b)(2), “newly discovered evidence” is limited in scope to “evidence of
facts which existed at the time of decision and of which the aggrieved party was excusably
ignorant.” TDM Am., LLC v. United States, 100 Fed. Cl. 485, 490 (2011). That is, it “only
encompasses facts which existed at the time the court made its decision and entered judgment.”

                                                12
Q Integrated Cos., LLC v. United States, 131 Fed. Cl. 125, 132 (2017); see also Sigmatech, Inc.
v. United States, 144 Fed. Cl. 159, 181 (2019).

        In addition to the requirement that the proffered evidence be newly discovered, RCFC
60(b)(2) also requires that it be material. Mark Dunning Indus., Inc., 143 Fed. Cl. at 738.
“Newly discovered evidence is material if the court’s decision would have been different had the
court been aware of it prior to judgment.” Id. at 740. The moving party must show that the
“evidence is material and controlling and clearly would have produced a different result if
presented before the original judgment.” Venture Indus. Corp. v. Autoliv ASP, Inc., 457 F.3d
1322, 1328 (Fed. Cir. 2006); see also Sigmatech, Inc., 144 Fed. Cl. at 175. Thus, in order to
vacate judgment and reopen a case under RCFC 60(b)(2), evidence must be both newly
discovered and material.

         The catch-all provision of RCFC 60(b)(6) provides for relief from judgment upon “any
other reason that justifies relief.” RCFC 60(b)(6). “The court is limited in granting relief under
RCFC 60(b)(6) in two respects: (1) the grounds asserted for relief must not be the same as those
listed in [RCFC] 60(b)(1)–(5), and (2) there must be a valid reason that justifies affording the
relief, usually broadly described as extraordinary circumstances.” Q Integrated, 131 Fed. Cl. at
132; see also Kenzora, 2015 WL 6121582, at *2 (citing Freeman, 35 Fed. Cl. at 283; Kennedy,
99 Fed. Cl. at 547; Liljeberg v. Health Servs. Acquisition Corp., 486 U.S. 847, 863 (1988)).
Clauses (1)-(4) are mutually exclusive with clauses (5) and (6), and thus, relief under clause (6)
cannot be asserted on one of those grounds. Pioneer Inv. Servs. Co. v. Brunswick Assocs. Ltd.
P’ship, 507 U.S. 380, 393 (1993); Kenzora, 2015 WL 6121582, at *2.

        In addition, in order to justify relief, a showing of “extraordinary circumstances” is
required. Kennedy, 99 Fed. Cl. at 548 (citing Ackermann v. United States, 340 U.S. 193, 202
(1950)). RCFC 60(b)(6) permits the decision maker to grant relief from judgment to a party only
in circumstances in which a “grave miscarriage of justice” would otherwise result. Id. at 540
(quoting United States v. Beggerly, 524 U.S. 38, 47 (1998)). This narrow use of RCFC 60(b)(6)
is essential in order to preserve the finality of judgments. Id. at 548 (citing Gonzalez v. Crosby,
545 U.S. 524, 535 (2005)). The party seeking relief from judgment “must show that the
extraordinary circumstances prevented [the] party from taking timely action to prevent or correct
an erroneous judgment.” Q Integrated, 131 Fed. Cl. at 132 (internal citations omitted).

V.     PARTIES’ POSITIONS

       A.      Petitioner’s Contentions

        Petitioner seeks relief from judgment pursuant to RCFC 60(b)(2), on the basis of “newly
discovered evidence.” Pet. Mot. at 5. She seeks to have her case reopened so that she may “file
additional medical records and medical expert opinion based on petitioner’s recent medical
course.” Id. In the alternative, “to the extent that [the] Court finds [RCFC] 60(b)(6) to be more
suitable grounds for reopening judgment . . . for the purpose of doing substantial justice, the
petitioner [] incorporates her [RCFC] 60(b) motion to include both 60(b)(2) and 60(b)(6).” Pet.
Reply at 5.

                                                13
        Petitioner summarized the facts underlying her original claim, stating that “approximately
two (2) weeks following the administration of her October 1, 2013 flu vaccination, [she]
developed symmetric ascending weakness, sensory loss, and hyporeflexia concerning for
[AIDP].” Pet. Mot. at 6. She further states that she was “diagnosed with GBS, and
subsequently, POEMS.” Id. Petitioner states that the undersigned determined that “the onset of
[petitioner’s] peripheral neuropathy was more likely than not POEMS syndrome at the outset of
her neurological symptoms.” Id.

        In the present motion, petitioner states that at the time of her flu vaccination on
November 8, 2020, her “POEMS syndrome was stable,” 12 but that “approximately two (2) weeks
following [her] November 2020 administration of the [flu] vaccination, she developed the onset
of bilateral leg weakness and numbness which progressed distally, and required the
administration of IVIG.” Pet. Mot. at 2, 7. Petitioner asserts that this is evidence of “rechallenge
following the 2020 flu vaccination [which] constitutes persuasive evidence regarding the role of
petitioner’s 2013 flu vaccination.” Id. at 7. “In light of this newly discovered evidence, the
petitioner respectfully requests that the Court grant relief from final judgment, so that her case
may be reopened to file additional medical records and medical expert opinion for the Special
Master’s consideration.” Id.

        In support of her motion, petitioner relies on Cabrera ex rel. L.C. v. Secretary of Health
& Human Services, No. 13-598V, 2019 WL 4898479 (Fed. Cl. Spec. Mstr. Sept. 10, 2019).
Petitioner notes that in Cabrera, “the injured minor had a relapse of his condition” after judgment
entered. Pet. Reply at 5. The evidence at issue in Cabrera “did not exist at the time of the
Special Master’s Decision, and the Court granted petitioners’ motion for relief from judgment
based on a showing of newly discovered evidence under 60(b)(2).” Id. at 6. Petitioner
characterizes her medical condition following her November 8, 2020 flu vaccination as a relapse,
similar to that suffered by the minor in Cabrera. Id. Petitioner also asserts that her medical
course after she received the flu vaccination on November 8, 2020 constitutes evidence of
challenge-rechallenge. Id. In summary, petitioner states “[t]he course of petitioner’s 2020
symptomatology was so strikingly similar to her initial presentation in 2013, both within two
weeks of receiving the flu vaccination, that it justifies consideration by this Court.” Id. at 14.

       B.      Respondent’s Contentions

       Respondent argues that petitioner has not met the requirements of RCFC 60(b)(2)
because she has failed to show that the proffered evidence is either “newly discovered” or
“material.” Resp. Response at 8. As to the issue of whether the evidence is newly discovered,
respondent asserts that the medical records of petitioner’s November 2020 vaccination and her
alleged episode of rechallenge “did not exist at the time of the Special Master’s decision in
December 2019 or, crucially, at the time of [the] Court’s decision in June 2020.” Id. Instead,
respondent contends that the records were “created later as a result of new factual
developments.” Id. According to respondent, the vaccination in November 2020 and subsequent
12
  In her motion, petitioner asserts that she was medically stable until her 2020 flu vaccination.
Pet. Mot. at 2; Pet. Reply at 13 n.7. This does not appear to be accurate. From May to July
2018, petitioner had a possible relapse. Pet. Ex. 91 at 110. Also, on February 4, 2019, petitioner
was diagnosed with a relapse by Dr. Dispenzieri. Id. at 541, 547.

                                                14
medical care had not occurred when the court entered judgment, and thus, the records do not
constitute newly discovered evidence. Id. at 8-9. Instead, respondent argues that the records
constitute “newly created evidence, which cannot now be retrospectively grafted onto
petitioner’s original claim in order to change the result.” Id. at 9 (emphasis omitted).

        With regard to the question of materiality, respondent, quoting Venture Industries
Corporation, states that petitioner must show that “that the evidence is material and controlling
and clearly would have produced a different result if presented before the original judgment.”
Resp. Sur-Reply at 6-7 (quoting Venture Indus. Corp., 457 F.3d at 1328). Respondent argues
that the medical records filed by petitioner “do[] not preponderantly prove the three Althen
prongs in such a clear and controlling way that, if the evidence had been before the original
Court, it would have produced a different result.” Id. at 7. Thus, respondent concludes that
petitioner’s motion amounts to “an invitation for the Court to investigate further whether to grant
relief by reopening the case and reweighing facts—an invitation that runs afoul of [RCFC]
60(b).” Id. Moreover, respondent disagrees with petitioner’s characterization of the effect of
“challenge/rechallenge evidence.” Id. at 7-9. Respondent does not agree that such evidence can
satisfy Althen prongs one or three. Id. at 8-9.

        Lastly, with regard to RCFC 60(b)(6), respondent contends petitioner has “not presented
the extraordinary circumstances required to disturb the finality of the judgment. Petitioner may
bring a new and distinct vaccine claim if she chooses. But she may not seek relief from
judgment simply to relitigate [her] case.” Resp. Sur-Reply at 9-10 (internal quotation marks
omitted).

VI.    ANALYSIS

       A.      Relief from Judgment Is Not Available Under RCFC 60(b)(2)

        The undersigned finds that the petitioner’s motion under RCFC 60(b)(2) is unavailing.
Pursuant to this rule, “newly discovered evidence” is limited to facts which “existed at the time
the court made its decision and entered judgment.” Q Integrated, 131 Fed. Cl. at 132; see also
TDM Am., 100 Fed. Cl. at 490-91; Yachts Am., Inc. v. United States, 8 Cl. Ct. 278, 281 (1985),
aff’d, 779 F.2d 656 (Fed. Cir. 1985). The evidence that petitioner relies upon here are records of
her November 8, 2020 vaccination and her subsequent hospitalization in December 2020. The
undersigned’s decision was filed in December 2019, and the Court’s decision issued on June 19,
2020, when judgment entered. Petitioner did not receive vaccine at issue until November 8,
2020, almost six months later. Therefore, the evidence does not qualify as “newly discovered.”

       Here, petitioner’s evidence is like that proffered in Q Integrated, in that it did not exist at
the time the court issued its decision and judgment entered. See Q Integrated, 131 Fed. Cl. at
132. Therefore, the evidence “cannot form the basis to grant the [] relief from judgment under
RCFC 60(b)(2).” Id.

        Cabrera is not inconsistent with this result. In Cabrera, the special master issued a ruling
on entitlement, determining that the petitioners’ minor child was entitled to compensation.
Cabrera, 2019 WL 4898479, at *1. Subsequently, the parties agreed on an award (proffer) of

                                                  15
compensation. Id. On May 28, 2019, the decision awarding damages issued, and judgment
entered on May 31, 2019. Id. On May 30, 2019, the day before judgment entered, the minor
child saw his treating rheumatologist who expressed “concern that [the child] was perhaps
experiencing a flare” of his vaccine-related injury, juvenile idiopathic arthritis. Id. at *2.
Diagnostic testing confirmed that the child was having a relapse of his vaccine-related illness.
Id. The evidence of relapse changed the factual presumption underlying the damages proffer,
namely that the child was in remission. Id. at *3. Since the child had an unexpected relapse,
present and future medical care were no longer accurately reflected in the proffer. See id. The
respondent had no objection to the motion. Id. In summary, the medical record documenting the
treating physician’s concerns about relapse existed prior to the entry of judgment, albeit by one
day. As such, the evidence “existed at the time the court made its decision and entered
judgment.” Q Integrated, 131 Fed. Cl. at 132.

        Moreover, petitioner’s evidence here does not meet the requirement of materiality under
RCFC 60(b)(2) because petitioner has not shown that it is “controlling and clearly would have
produced a different result if presented before the original judgment.” Venture Indus. Corp., 457
F.3d at 1328. The question of materiality is two-fold: would the evidence have changed the
undersigned’s analysis and findings as to diagnosis and causation.

        In the underlying case, the parties agreed that petitioner was appropriately diagnosed with
POEMS syndrome, but they disputed the onset of the condition, as well as the appropriate
diagnosis for her neuropathy-related symptoms in October and November 2013. Both parties
devoted time at the hearing addressing whether vaccine-induced GBS could be shown to cause
POEMS syndrome. The medical records, however, suggested a more pertinent question:
whether petitioner ever had GBS at all. The medical theory of causation proffered by petitioner
hinged on the undersigned’s finding that her neuropathy-related symptoms in October and
November 2013 were attributable to a GBS diagnosis, not POEMS. Therefore, if petitioner did
not suffer from GBS at the outset, then her claim could not succeed.

        A brief summary of the evidence outlined in the decision establishes that petitioner was
seen by Dr. Dispenzieri, 13 a hematologist at the Mayo Clinic, in June 2015. Dr. Dispenzieri
placed the onset of petitioner’s POEMS disease in October 2013, when petitioner had fatigue,
numbness/tingling, and eruptions of cherry angiomas of the skin. Pet. Ex. 19 at 27. Both of
respondent’s experts agreed that Dr. Dispenzieri’s opinion was persuasive, and that petitioner
had POEMS at the outset of her illness. 14 Dr. Dispenzieri did not opine that GBS or CIDP was
an alternative or concurrent diagnosis.

       After reviewing and considering the medical records, expert opinions, medical literature,
and the testimony at the hearing, the undersigned analyzed the issue of petitioner’s diagnosis and
found that respondent’s expert, Dr. Lipe, was more persuasive, for all of the reasons discussed.
13
     Dr. Dispenzieri has been petitioner’s treating physician since 2015.
14
  Dr. Lipe referred to petitioner’s visit to the Mayo Clinic, where she was seen by Dr.
Dispenzieri, as supportive evidence of the POEMS diagnosis. Decision at 25. Dr. Bourdette
agreed. Id. at 29-30.

                                                  16
See Decision at 36-39. Thus, the undersigned found it was improbable that petitioner suffered
from GBS as a precursor illness to her later-diagnosed POEMS syndrome.

         The newly filed medical records do not provide evidence to the contrary. Instead, the
records confirm that since May 2015, 15 the petitioner has continuously had the diagnosis of
POEMS syndrome, not GBS. Petitioner received a flu vaccine on November 8, 2020. On
December 12, 2020, she presented to the ED at Littleton Regional where she was seen by Dr.
Levitan. Dr. Levitan’s physical examination revealed “[d]iscomfort with palpation diffusely
below the knees bilaterally” and good range of motion. Pet. Ex. 89 at 55. Petitioner was “able to
lift [her] legs off the bed, [but could not] toe walk.” Id. She had “[g]ood strength in her upper
extremities.” Id. Labs were drawn, and petitioner’s “inflammatory makers were normal.” Id. at
57. Dr. Levitan’s diagnoses were polyneuropathy and POEMS. Id. Dr. Levitan did not
diagnosis petitioner with GBS.

         After she was discharged from the hospital, petitioner was seen for follow up by her
neurologist, Dr. Umashankar. She complained of fatigue and pain and requested another IVIG
infusion. Dr. Umashankar’s diagnoses were POEMS syndrome and polyneuropathy. He noted
that “[i]nterestingly[,] she had a flu shot about 2 weeks before the onset of symptoms in
December 2020.” Pet. Ex. 90 at 4. He stated, “I am honestly stumped if this was worsening of
her neuropathy of POEMS syndrome or if this was [GBS].” Id. While Dr. Umashankar
questioned whether petitioner had GBS, he did not diagnosis her with GBS.

       Petitioner has not filed any medical records that show that she was diagnosed with GBS
following the flu vaccine administered to her in November 2020. Thus, the undersigned finds
that the newly filed evidence would not have changed the result of her previous finding that
preponderant evidence supported petitioner’s diagnosis of POEMS.

         The undersigned’s conclusion that petitioner did not suffer from GBS at the outset of her
illness largely moots petitioner’s arguments that the flu vaccine played any role in her
development of POEMS syndrome thereafter, given that petitioner’s theory required a finding
that she experienced vaccine-induced GBS. See Hibbard v. Sec’y of Health & Hum. Servs., 698
F.3d 1355, 1364-65 (Fed. Cir. 2012) (finding it was not error for the special master to focus first
on whether petitioner suffered an autonomic neuropathy when petitioner asserted the flu vaccine
caused autonomic neuropathy, which manifested as dysautonomia and postural orthostatic
tachycardia syndrome). However, the undersigned now considers the new evidence offered in
support of causation.

        Specifically, petitioner contends that the newly filed records provide evidence of
rechallenge. Challenge/rechallenge evidence has been recognized as an appropriate form of
evidence to satisfy the second prong of Althen. Capizzano v. Sec’y of Health & Hum. Servs.,
440 F.3d 1317, 1322-26 (Fed. Cir. 2006). “A ‘challenge/rechallenge’ circumstance exists when
a person has a reaction to one administration of a vaccine or drug and then suffers worsening
symptoms after an additional administration of the same vaccine or drug.” Hirmiz v. Sec’y of
Health & Hum. Servs., 119 Fed. Cl. 209, 219 n.11 (2015); see also DePena v. Sec’y of Health &
15
 In the underlying case, the petitioner filed her medical records through May 2015, and these
were summarized in the decision denying entitlement. See Decision at 4-9.

                                                17
Hum. Servs., 133 Fed. Cl. 535, (2017) (describing challenge/rechallenge as “when an individual .
. . exhibits a more severe reaction to a second administration of that vaccine”). And as noted by
petitioner, Congress stated that “[a]n adverse event can be causally linked to a vaccine more
readily if: . . . the event recurs on re-administration of the vaccine (positive rechallenge).” Pet.
Mot. at 6 (quoting H.R. Rep. No. 106-977, at 5 (2000)).

        While the undersigned recognizes the concept of challenge/rechallenge, it does not
appear to be supported by the facts set forth in petitioner’s newly filed medical records. These
records show that petitioner received flu vaccines in 2015, 2017, and again in 2018. See Pet. Ex.
89 at 66, 71; Pet. Ex. 91 at 5, 682. No adverse reaction to any of these flu vaccines was
documented.

       In her underlying petition, petitioner alleged that the flu vaccine she received in October
2013 caused her to develop GBS. Based on the concept of challenge/rechallenge, petitioner
should have experienced a worsening of her symptoms after receiving the flu vaccine in 2015,
2017, and 2018. However, the records do not document that petitioner had any adverse reaction
to the flu vaccines she received in 2015, 2017, and 2018. Thus, the facts do not support a finding
of positive rechallenge.

       Moreover, petitioner’s case (based on her 2013 flu vaccine) was pending in 2015, 2017,
and 2018 when petitioner received flu vaccines for those years. If she had experienced a
worsening of her symptoms associated with any of those vaccinations, she would have had the
opportunity to submit evidence and argue challenge/rechallenge at the time. She did not do so.

       In summary, petitioner’s argument based on challenge/rechallenge is not supported by the
newly filed evidence. The evidence is not controlling or clear, and it does not establish that the
undersigned would have issued a different ruling as to causation. Therefore, it does not meet the
required criteria of materiality.

       B.      Relief from Judgment Is Not Available Under RCFC 60(b)(6)

        RCFC 60(b)(6) is often referred to as the “catch all” provision. It allows a court to
reopen a case and vacate a judgment for “any other reason that justifies relief.” RCFC 60(b)(6).
The rule must be narrowly construed in order to preserve the finality of judgments. Kennedy, 99
Fed. Cl. at 548 (citing Gonzalez, 545 U.S. at 535). Relief from judgment under RCFC 60(b)(6)
must be justified by a showing of “exceptional circumstances,” where a “grave miscarriage of
justice would result if relief is denied.” Id. at 540, 548. However, “[RCFC] 60 relief is not
available as a means to relitigate claims that have already been decided; if it were, then no
decision would ever be final.” Rogero v. Sec’y of Health & Hum. Servs., 143 Fed. Cl. 21, 27.
(2019).

       Pursuant to the Vaccine Rules promulgated by the Court of Federal Claims, the parties
must be afforded “a full and fair opportunity to present [their] case.” Vaccine Rule 3(b)(2). The
substantial rights of a petitioner may be harmed if they are deprived of “a full and fair
opportunity to be heard on the merits.” Kollasch ex rel. Q.K. v. Sec’y of Health & Hum. Servs.,
No. 10-717V, 2021 WL 1728714, at *4 (Fed. Cl. Spec. Mstr. Apr. 6, 2021). “A full and fair

                                                18
opportunity to be heard [] contemplates a procedural mechanism of adequate notice and a
measure of time for the presentation of the party’s position.” Guillot v. Sec’y of Health & Hum.
Servs., No. 03-0775V, 2012 WL 3867160, at *8 (Fed. Cl. Spec. Mstr. Aug. 15, 2012), mot. for
relief & mot. for reconsideration denied, 2012 WL 4788569 (Fed. Cl. Spec. Mstr. Sept. 13,
2012); see also Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 401 (1997) (holding
that petitioners were given a full and fair opportunity to present their case through the use of
permitted extensions and late filings). Further, an adequate record must be created to allow
motions for review and appeals to be filed. See Campbell v. Sec’y of Health & Hum. Servs., 69
Fed. Cl. 775, 778 (2006).

         Here, petitioner has not demonstrated “exceptional circumstances” or that a “grave
miscarriage of justice” would result if her motion is not granted. Petitioner filed her petition on
October 15, 2015. She was represented by very competent counsel, experienced in Vaccine
Program litigation. Over time, petitioner’s clinical course evolved, and it took considerable time
for the petitioner to obtain and file all of her medical records. Her clinical course was complex.
Numerous expert reports were filed along with numerous medical literature articles. A two-day
hearing was held on January 29 and 30, 2019. Petitioner and her husband, a medical doctor,
testified. Petitioner’s experts, Dr. Latov, a neurologist and Professor of Neurology at Cornell
University, and Dr. Parekh, a hematologist and Associate Professor of Hematology and
Oncology at the Icahn School of Medicine at Mount Sinai Medical Center, also testified. Pre-
and post-hearing submissions were filed by petitioner. After the hearing, petitioner’s expert, Dr.
Latov, filed additional medical literature. See Pet. Exs. 76-86. Motions for extensions of time
were liberally granted to allow petitioner requested time for filing records, briefs, expert reports,
or other documents. Petitioner was afforded a full and fair opportunity to present her case and
there is no showing that she has been deprived of her substantial rights as related to the
adjudication of her claim.

        Further, petitioner has not shown any basis to reopen her case based on exceptional
circumstances. Petitioner may file a new petition for her alleged injury related to the flu vaccine
that she received in November 2020. However, to reopen a case where judgment has entered, on
the basis of evidence that occurred seven years after the original vaccination in question, and
based on evidence that does not support a different outcome, is contrary to the purpose
underlying RCFC 60(b) that there be some finality and end to litigation.

VII.   CONCLUSION

       The undersigned has great sympathy for the suffering that petitioner has experienced.
However, for the reasons discussed above, the undersigned finds that petitioner’s newly filed
evidence does not warrant reopening and relitigating the claim set forth in her petition filed in
2015, alleging an injury related to the flu vaccine administered to her in October 2013.
Therefore, the undersigned DENIES petitioner’s motion for relief for judgment.

        IT IS SO ORDERED.
                                                      s/Nora Beth Dorsey
                                                      Nora Beth Dorsey
                                                      Special Master

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