VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-01207
Package ID: USCOURTS-cofc-1_15-vv-01207
Petitioner: R.S.
Filed: 2015-10-15
Decided: 2020-07-17
Vaccine: influenza
Vaccination date: 2013-10-01
Condition: Guillain-Barré syndrome (GBS) and polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
Outcome: denied
Award amount USD: 

AI-assisted case summary:
R.S., a 41-year-old female, received an influenza vaccine on October 1, 2013. She subsequently developed symptoms including weakness, numbness, and pain, initially diagnosed as probable Guillain-Barré Syndrome (GBS) and later Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Over time, her condition evolved, and she was diagnosed with Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Gammopathy, and Skin Changes (POEMS) syndrome in August 2014. Petitioner argued that the flu vaccine caused GBS, which in turn led to POEMS syndrome. Petitioner's experts, Drs. Latov and Parekh, supported this theory, suggesting a mechanism of chronic immune stimulation. Respondent's experts, Drs. Lipe and Bourdette, argued that petitioner's symptoms from the outset were indicative of POEMS syndrome, not GBS, and that the flu vaccine was unrelated. The Special Master denied entitlement, finding that petitioner failed to prove by a preponderance of the evidence that she suffered from GBS as a precursor to POEMS. The Special Master found the respondent's experts' opinions more persuasive, concluding that petitioner's symptoms were more consistent with POEMS syndrome from the beginning. Furthermore, the Special Master found that petitioner failed to establish a sound and reliable medical theory linking the flu vaccine to GBS and subsequently to POEMS, noting that the proposed mechanism was novel and unsupported by sufficient scientific evidence. This decision was affirmed on review by the Court of Federal Claims, which found the Special Master's findings were not arbitrary or capricious.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-01207-1
Date issued/filed: 2020-01-23
Pages: 42
Docket text: PUBLIC DECISION (Originally filed: 12/19/2019) regarding 136 DECISION of Special Master. Signed by Special Master Nora Beth Dorsey. (mjf) Service on parties made.
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Case 1:15-vv-01207-RTH Document 146 Filed 01/23/20 Page 1 of 42
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Originally Filed: December 19, 2019
Refiled in Redacted Form: January 23, 2020
* * * * * * * * * * * * * * *
R.S., * PUBLISHED
*
Petitioner, * No. 15-1207V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Entitlement Decision; Influenza (“flu”)
AND HUMAN SERVICES, * Vaccine; Guillain-Barré Syndrome (“GBS”),
* Polyneuropathy, Organomegaly,
* Endocrinopathy, Monoclonal Gammopathy,
Respondent. * and Skin Changes (“POEMS”) Syndrome;
* Onset.
* * * * * * * * * * * * * * *
Ronald C. Homer, Conway, Homer, P.C., Boston, MA, for petitioner.
Linda S. Renzi, U.S. Department of Justice, Washington, DC, for respondent.
DECISION1
I. INTRODUCTION
On October 15, 2015, R.S. (“petitioner”) filed a petition under the National Vaccine
Injury Compensation Program (“Vaccine Act” or “the Program”),2 42 U.S.C. § 300aa- 10 et seq.
(2012), 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 When this decision was originally filed 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. This decision is being reissued with initials, R.S. or S., in place of
petitioner’s name. Except for those changes and this footnote, no other substantive changes have
been made. This decision will be posted on the court’s website with no further opportunity to
move for redaction.
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 decision to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.
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Case 1:15-vv-01207-RTH Document 146 Filed 01/23/20 Page 2 of 42
1-2. Respondent argued against compensation, stating that “this case is not appropriate for
compensation under the terms of the Vaccine Act.” Respondent’s Report (“Resp. Rept.”) at 2
(ECF No. 17).
After carefully analyzing and weighing the evidence presented in this case in accordance
with the applicable legal standards, the undersigned finds that petitioner has failed to provide
preponderant evidence that the flu vaccine she received on October 1, 2013, caused her injuries.
Therefore, entitlement must be denied.
II. PROCEDURAL HISTORY
The petition was filed in this matter on October 15, 2015. Shortly thereafter, on October
26, 2015, petitioner filed seven medical record exhibits. Petitioner’s Exhibits (“Pet. Exs.”) 1-7
(ECF No. 7). Petitioner filed additional medical records, her supporting affidavit, and a
Statement of Completion on October 27, 2015. Pet. Exs. 8-23 (ECF Nos. 9-10); Pet. Aff. dated
Oct. 27, 2015 (ECF No. 11). On February 22, 2016, respondent filed his Rule 4(c) Report,
recommending against compensation. Resp. Rept. at 2.
A status conference was held in April 2016 to determine next steps in the case, and the
parties agreed that petitioner should file an expert report. Order dated Apr. 27, 2016 (ECF No.
18). Petitioner filed two additional sets of medical records on March 26, 2016 and June 6, 2016,
respectively. Pet. Exs. 24-28 (ECF Nos. 21, 25). On August 5, 2016, petitioner filed an expert
report by Dr. Norman Latov. Pet. Ex. 29 (ECF No. 26). Respondent thereafter filed a
responsive expert report by Dr. Dennis Bourdette on January 6, 2017. Resp. Ex. A (ECF No.
33). 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 23, 2017. Pet. Ex. 31 (ECF No. 35).
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. Rather, both parties agreed that expert reports addressing the
hematologic aspect of petitioner’s claim would be helpful. Respondent filed an expert report by
Dr. Brea Lipe on June 16, 2017. Resp. Ex. C (ECF No. 40). On December 4, 2017, petitioner
submitted a responsive report from Dr. Latov. Pet. Ex. 38 (ECF No. 54). After a number of
months, petitioner filed an expert report from Dr. Samir Parekh on October 11, 2018. Pet. Ex. 57
(ECF No. 75).
On June 20, 2018, the undersigned set this matter for hearing to take place on January 29-
30, 2019. Order dated June 20, 2018 (ECF No. 72). The parties completed their respective pre-
hearing filings by early January 2019, and the hearing took place as scheduled. The parties filed
post-hearing briefs on April 26, 2019 and July 24, 2019, respectively.
This matter is now ripe for adjudication.
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Case 1:15-vv-01207-RTH Document 146 Filed 01/23/20 Page 3 of 42
III. MEDICAL TERMINOLOGY
As the literature filed in this case establishes, 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-S22.3 The primary clinical features of the disease are
generalized muscle weakness combined with sensory symptoms. Id. at S21. Symptoms
indicative of GBS typically begin abruptly with paresthesia in the feet, progressing to paralysis
of the lower limbs, and ascending to the trunk, limbs, and face. Id. at S21-S22. Weakness of the
facial muscles and respiratory complaints are also common features. Id. Patients suffering from
GBS typically experience a monophasic course and reach nadir between two and four weeks
following onset. Id. at S21. Chronic inflammatory demyelinating polyneuropathy (“CIDP”) is a
chronic form of GBS, which progresses slowly over time, but manifests similar symptoms. Resp.
Ex. E, Tab 1 at 477.4 Patients with symptoms consistent with GBS, but lasting longer than two
months, are typically considered to be suffering from CIDP.
POEMS syndrome, by contrast, is a paraneoplastic syndrome due to an underlying
plasma cell disorder. Pet. Ex. 29, Tab F at 214.5 Typical features of the syndrome include:
demyelinating polyradiculoneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell
disorder, and skin changes. Id. The diagnostic criteria for the condition requires a patient to
satisfy two mandatory criteria: polyneuropathy and monoclonal gammopathy, along with one of
the following: elevated serum vascular endothelial growth factor (“VEGF”) levels, sclerotic bone
lesions, or Castleman’s disease. Id. Additionally, patients suffering from POEMS may have
various minor criteria, such as papilledema and thrombocytosis. Id. The progression of
symptoms is gradual, with the median time from onset to diagnosis being thirteen to eighteen
months. Resp. Ex. C, Tab 4 at 304.6 Misdiagnosis of the illness is common due to its rarity and
multi-system manifestations. Id. The most common misdiagnoses, based on the initial
symptoms, include CIDP, diabetes, and nephritis. Id.
Despite their differences, distinguishing between POEMS and GBS/CIDP is difficult
during the early phases given the similarities in the initial presenting neuropathy. The literature
filed in this matter suggests that over half of POEMS patients presenting with a related
polyneuropathy are diagnosed initially with CIDP. Resp. Ex. E, Tab 1 at 477. Clinically, POEMS
patients typically experience distal muscle weakness in the lower extremities only, while patients
3 Arthur Asbury & David Cornblath, Assessment of Current Diagnostic Criteria for Guillain-
Barré Syndrome, 27 Ann. Neurol. S21 (1990).
4 Saiko Nasu et al., Different Neurological and Psychological Profiles in POEMS Syndrome and
Chronic Inflammatory Demyelinating Polyneuropathy, 83 J. Neurol. Neurosurg. Psychiatry 476
(2012).
5 Angela Dispenzieri, CME Information: POEMS Syndrome: 2014 Update on Diagnosis, Risk-
Stratification, and Management, 89 Am. J. Hematol. 213 (2014).
6 Jian Li & Dao-Bin Zhou, New Advances in the Diagnosis and Treatment of POEMS
Syndrome, 161 Brit. J. Hematol. 303 (2013).
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with GBS/CIDP experience weakness in both the upper and lower limbs. Id. In addition, patients
with POEMS usually complain of neuropathic pain in the lower extremities, whereas patients
with symptoms akin to GBS/CIDP rarely complain of pain. Id. Patients whose symptoms are
initially believed to be compatible with GBS/CIDP may later be diagnosed with POEMS
syndrome based on the subsequent course of illness as additional symptoms manifest.
Although intravenous immunoglobulin (“IVIG”) treatments are utilized successfully in
resolving both GBS and CIDP, single agent IVIG therapy is not considered to be the most
effective treatment for POEMS syndrome. Pet. Ex. 29, Tab F at 220. Case reports, however, do
indicate that IVIG treatment can result in a reduction of serum VEGF levels and clinical
improvement in some patients. Id. Indeed, even after initial treatment with IVIG therapy,
POEMS syndrome will become progressively worse until the proper treatment is administered.
Radiation, melphalan-dexamethasone, and corticosteroids typically result in the most noted
improvement in the majority of POEMS syndrome cases. Id. at 219-20.
IV. FACTUAL SUMMARY
A. Medical History Prior to Vaccination
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.
B. Receipt of Vaccination and Subsequent Clinical Course
i. Medical Treatment in 2013
R.S. received the flu vaccine at issue herein 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 Umashanker, 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. Umashanker 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. Umashanker, 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 exam, 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. Umashanker assessed R.S. with “probabl[e]” GBS
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
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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. Umashanker, 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 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 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.
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 thirty-six hours prior to presentation. Id. at 658. It
was noted that she received a flu vaccine in early October. Id. at 658, 659.
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
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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. Petitioner reported that she continued to experience weakness, but could ambulate
well with a walker. Pet. Ex. 7 at 471-72. On exam, 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 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 Ms. Saver’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.
ii. 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.
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 CIDP diagnosis. Pet.
Ex. 5 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 and nerve conduction analysis, 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 CSF. 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.
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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. 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. at 18. Dr. Dineen did not think that further IVIG treatment would be helpful at this
time. Id.
iii. POEMS Diagnosis and Treatment in July and August 2014
R.S. presented to Littleton Regional Hospital 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. Umashanker 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.
On July 31-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 syndrome and he
recommended a hematology consult. 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 level, 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. She also reported
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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 VEGF7 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.
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. 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.
iv. Medical Care in 2015 and Current Condition
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. 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. Pet. Ex. 19 at 27. 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.
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,
7 VEGF levels are elevated in patients diagnosed with POEMS syndrome. See 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.
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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 that R.S.’s course was consistent with POEMS syndrome. Id. at 30.
As of May 2015, R.S. continues to be treated for POEMS. Pet. Ex. 18 at 562. She
routinely experiences 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.
V. Fact and Expert Testimony
A. Fact Witnesses
i. Russell S., M.D.
Dr. S., petitioner’s husband, testified about her health history and course following her
receipt of the flu vaccine at issue herein. Tr. 139. Prior to receiving the flu vaccine, Mr. S
described petitioner as healthy and physically active. Tr. 142. She enjoyed skiing, hiking,
completing household tasks, and spending time with the family dogs. Tr. 142, 144. R.S.
worked as a medical assistant/consultant with a primary focus on electronic medical record
training and administration. Tr. 143. Dr. S. testified that petitioner’s position as a consultant
was demanding, but she enjoyed the social interaction and travel-related responsibilities. Tr.
143-44.
Dr. S. next recalled petitioner’s deterioration in health following her receipt of the flu
vaccine. Tr. 145. He testified that petitioner returned from a work conference shortly after
receiving the flu vaccine, at which time she began complaining of calf pain and numbness in the
feet. Id. Given his medical training, Dr. S. suspected that petitioner might have GBS, but she
initially attributed these early-in-time symptoms to travel fatigue or perhaps the wearing of high-
healed shoes. Tr. 145-46.
According to Dr. S., petitioner first sought treatment for her symptoms around the
beginning of November 2013. Tr. 146. He recalled that petitioner complained of persistent calf,
upper leg, and back pain. Id. She had also fallen several times at work. Tr. 146-47. Her
symptoms rapidly progressed to include numbness and tingling in the feet, ankles, and hands.
Tr. 147. Petitioner also experienced paralysis, drooling, palpitations, nerve pain, and breathing
difficulties, which prompted her initial emergency room visit on November 6, 2013 to
Dartmouth Hitchcock. Tr. 147-48.
During her initial hospitalization, Dr. S. recalled that petitioner’s symptoms improved
immediately upon receiving IVIG treatment. Tr. 150. She gained back much of her strength
following two to three doses. Id. Upon discharge, R.S. needed assistance with
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standing. Tr. 151. She also experienced problems with her balance. Id. Otherwise, she returned
home following clearance by her physical and occupational therapists. Id.
In the days following her initial hospitalization, Dr. S. stated that petitioner expressed
concern regarding the length of time of her recovery. Tr. 152. Petitioner’s recovery remained
steady and she expressed interest in returning to work. Id. Roughly two weeks later, however,
she experienced a relapse in symptoms. Id. The pain, numbness, and weakness started in her feet
and progressed up her body. Id. Petitioner was hospitalization a second time, but improved
following additional rounds of IVIG treatment. Tr. 153. Dr. S. recalled that both he and
petitioner understood her recovery would be gradual, but they both expected a full recovery
consistent with a GBS course. Tr. 53-54.
Following a third hospitalization, Dr. S. recalled that petitioner’s treaters expressed some
skepticism regarding the progression of her symptoms, as such treatment-related fluctuations
attributable to GBS did not usually progress for extended periods of time. Tr. 154. Dr. S.
recalled that petitioner’s doses of IVIG administered during the third hospitalization did not
result in the same improvement as the previous infusions. Tr. 155-56. According to Dr. S.,
around December 2013, petitioner’s diagnosis changed to CIDP, which he understood to be a
chronic form of GBS. Tr. 160. He recalled that petitioner’s treaters recommended a change in
medication to include steroids and Cellcept. Id.
Consistent with the medical records detailed above, Dr. S. recalled that petitioner was
assessed for other health concerns as her course progressed (primarily during January 2014). Tr.
160. Specifically, petitioner developed aseptic meningitis following a rapid administration of
IVIG. Tr. 160-61. Treaters also identified thoracic lesions following a full-body MRI, which
resulted in a lymphoma work-up and lesion removal thereafter in February of that year. Tr. 161-
62. Petitioner’s surgery and weakened state resulted in an extended stay in a rehabilitation
facility throughout March, April, and May 2014. Tr. 163.
Dr. S. next recalled petitioner’s course throughout July and August 2014, along with her
initial diagnosis of POEMS. Tr. 163. Dr. S. recalled that petitioner began to complain of a
significant increase in angiomas, weight loss, fatigue, and further gait abnormalities throughout
this time period. Tr. 163-65. In July 2014, petitioner also began to experience intercranial
pressure, which resulted in a brain shunt, and papilledema. Tr. 165-66. Following a hematologic
consult in August of that year, Dr. S. recalled that petitioner’s treaters suspected she had
POEMS due to her elevated platelet levels and serum VEGF. Tr. 166.
Dr. S. also attended petitioner’s appointment at the Mayo Clinic with Dr.
Dispenzieri. Tr. 167. According to Dr. S., petitioner’s treaters recommended she see Dr.
Dispenzieri given her extensive experience with POEMS patients and the overall rarity of the
disease. Tr. 168. In his view, petitioner scheduled the visit to discuss the best treatment protocol
moving forward. Id. He did not recall Dr. Dispenzieri discussing the onset of petitioner’s
POEMS or her initial GBS diagnosis. Tr. 168-69.
Given the extent of her health deterioration over the course of 2013 and 2014, Dr. S.
testified that petitioner continues to experience a number of ongoing physical disabilities due to
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her condition. Tr. 172. She has fatigue, pain, and balance issues. Tr. 172, 176. These ailments
require routine maintenance, including daily medication. Tr. 176-77. Due to the pressure on her
brain, petitioner underwent a surgical procedure to insert a brain shunt which helped with her
balance. Tr. 176. She also continues to suffer from anxiety and depression. Tr. 172-73. Dr. S.
expressed concern regarding petitioner’s health in the long term given her persistent
physical limitations and mental health issues. Tr. 177-78.
ii. R.S.
Petitioner, R.S., also testified at hearing. Tr. 179. Her testimony largely consisted of her
own recollections of her overall health history prior to receiving the flu vaccine, as well as
descriptions of the symptoms that followed. Prior to October 2013, petitioner described herself
as healthy, physically active, and outgoing. Tr. 181, 184. She worked as a medical
assistant/consultant and enjoyed the travel and social interaction her job required. Tr.
181-82, 184-85.
Petitioner recalled the day she received the vaccine at issue in this matter. Tr. 186. She
described the day as normal. Id. She did not experience any unusual symptoms during vaccine
administration or in the days immediately thereafter. Id. Petitioner stated that she first began to
experience adverse symptoms, such as numbness in the feet and fatigue, roughly two weeks post
vaccination. Tr. 186-88.
By early November 2013, however, R.S. recalled that her symptoms progressed to
include gait and swallowing abnormalities, pain, numbness in the fingers and legs, and drooling.
Tr. 188-89. Following initial treatment with IVIG, petitioner testified that she felt “remarkably
better.” Tr. 191. Petitioner reported that she could ambulate with a walker and regained some of
her upper body strength upon discharge. Tr. 192. Despite her symptoms, petitioner’s treaters
indicated to her that she should expect to recover fully, though the overall healing would take
time. Id. Following two additional hospitalizations for a relapse of symptoms, R.S. recalled that
IVIG treatment seemed to be less effective. Tr. 193-95.
Leading up to her POEMS diagnosis in August 2014, Petitioner testified that she began to
experience head pain/cranial pressure and papilledema in the summer of 2014. Tr. 195-96. She
recalled the day her treaters recommended a blood draw to measure her serum VEGF. Tr. 198.
Roughly two weeks later, she was diagnosed with POEMS syndrome. Id.
R.S. next recalled her visit with Dr. Dispenzieri at the Mayo Clinic. Tr. 199. She stated
that her treaters recommend she see Dr. Dispenzieri given her expertise in the disease. Id.
Petitioner reported that that she discussed various treatment options with Dr. Dispenzieri to
determine how best to proceed with the overall management of the disease. Id. Despite her
satisfaction with Dr. Dispenzieri’s recommendations, R.S. took issue with some of the visit
notes indicating that her POEMS syndrome began in late 2013. Tr. 200. Rather, R.S. reported
that she may have felt “run down” from working, but she did not recall experiencing any other
adverse symptoms apart from normal angiomas. Tr. 201.
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Consistent with Dr. S.’s testimony, petitioner reported that she continues to suffer from
adverse symptoms related to her illness. Tr. 201-02. She attends multiple doctor visits to manage
her symptoms. Tr. 204. For instance, Petitioner noted that she has undergone a shunt placement
procedure and stem cell transplant to help abate her disease progression. Tr. 203. She also
continues to suffer from depression. Id. All in all, R.S. expressed frustration in her inability to
work, to take part in outdoor activities, and to actively participate in family life. Tr. 203-04.
B. Expert Witnesses
i. Norman Latov, M.D.
Dr. Latov provided an opinion on petitioner’s behalf as to the etiology of R.S.’s
condition, along with the flu vaccine’s purported role in causing her symptoms. Dr. Latov
opined that R.S. was properly diagnosed with GBS, which was vaccine-caused, and that her
subsequent diagnosis of POEMS was caused by GBS. Tr. 33-34, 52. Dr. Latov filed three
expert reports in support of his medical theory of causation. See Pet. Exs. 29, 31, 38.
Dr. Latov obtained his medical degree from the University of Pennsylvania. Tr. 7; Pet.
Ex. 30 at 1. After medical school, Dr. Latov went on to complete a neurology residency and
immunology fellowship at Columbia University. Tr. 7. He then joined the faculty at Columbia,
where his research and teaching responsibilities focused on autoimmune neuropathies. Tr. 7-8.
At present, Dr. Latov serves as a Professor of Neurology and Neuroscience, and the Director of
the Peripheral Neuropathy Center, at Cornell University. Tr. 8. His clinical duties include
supervising medical students and attending to patients in the neuropathy center. Tr. 8-9. Dr.
Latov estimated that his clinic practice represents sixty percent of his current work. Tr. 9. He
testified that he treats patients with all forms of neuropathy, including GBS and CIDP. Tr. 11.
He also follows roughly ten patients with POEMS syndrome. Id. Dr. Latov also conducts
research in the fields of neurology and neuroimmunology, and he is board certified in neurology
and psychiatry. Tr. 8-9.
To begin, Dr. Latov reviewed R.S.’s symptoms and the progression of her condition
compared to the most common features of GBS. Dr. Latov defined GBS as an acute, or rapidly
progressive neuropathy, in which the immune system attacks the myelin component of the
peripheral nerves. Tr. 13, 21; Pet. Ex. 29 at 7. A typical GBS course includes generalized
weakness, tingling, pain, unsteady gait, cranial nerve involvement, and loss of bowel function.
Tr. 14. Demyelination of the nerve can also result in secondary axonal loss, which leads to
chronic muscle atrophy and weakness. Tr. 21. GBS is distinguished from other types of
neuropathies by using an array of diagnostic testing, including a physical exam, nerve
conduction studies, CSF analysis, and MRI imaging. Tr. 13. The condition is routinely treated
with plasmapheresis or IVIG. Tr. 15.
Dr. Latov next discussed petitioner’s health history in the weeks prior to her first hospital
admission on November 6, 2013, and its relationship to her initial GBS diagnosis and subsequent
progression of symptoms. Based on his review of the medical record, Dr. Latov recalled that
petitioner developed neuropathy-related symptoms, including progressive weakness and
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paresthesia in the hands, two weeks following her receipt of the flu vaccine on October 1, 2013.
Tr. 12-13. She also complained of calf pain, ascending hip pain, numbness in the fingers, and
drooling, all of which Dr. Latov characterized as typical GBS-related symptoms. Tr. 13-14.
Dr. Latov relied heavily on petitioner’s contemporaneous diagnostic testing in
formulating his opinion regarding her October and November 2013 neuropathy symptoms. As
the medical record reveals, the testing completed during petitioner’s initial hospitalization
showed an increased CSF protein, but no inflammatory changes. Tr. 12. EMG and nerve
conduction studies were also consistent with a GBS diagnosis. Id. Petitioner thereafter
experienced a rapid improvement in strength following treatment with IVIG therapy. Tr. 13, 15;
see Pet. Ex. 7 at 3-4, 14.8 Given the above, Dr. Latov posited that petitioner’s early symptoms
were consistent with GBS and he felt that her treating physicians correctly identified the
diagnosis and treated her appropriately. Tr. 15.
Following her initial diagnosis, Dr. Latov reported that petitioner experienced two
presumed GBS-related relapses. Tr. 12; Pet. Ex. 29 at 9-10. After her second hospital
admission, Dr. Latov noted that petitioner received additional rounds of IVIG therapy with noted
improvement in her muscle strength. Tr. 17-18; see Pet. Ex. 5 at 662-64; Pet. Ex. 17 at 18.
Similarly, in his view, petitioner responded well to IVIG treatment following her third relapse.
Tr. 18-20; see Pet. Ex. 17 at 8, 18; Pet. Ex. 7 at 322. Due to her protracted course, Dr. Latov
categorized these relapses as “GBS with treatment-related fluctuation.” Tr. 20 (“each treatment
seems to result in improvement for about two weeks, and then she would relapse’), 21.
As her course continued to deteriorate, Dr. Latov noted that petitioner’s diagnosis
changed to CIDP around mid-December 2013 due to the repeated relapses outlined above. Tr.
22; Pet. Ex. 29 at 10. Dr. Latov described CIDP as a “sort of chronic” GBS. Tr. 22. In his
experience, patients suffering from GBS relapses extending beyond two months are best
categorized as experiencing CIDP. Id. Indeed, the medical literature cited by Dr. Latov defines
CIDP as immune-mediated neuropathy with an initial phase lasting more than two months,
whereafter the course may be relapsing-remitting, steadily progressive, or monophasic. See Pet.
Ex. 29, Tab O at 1680.9 Consistent with R.S.’s treaters, Dr. Latov posited that he would have
designated a change in her diagnosis to CIDP at this time given her persistent symptoms. Tr. 22.
By July 2014, R.S. was diagnosed with POEMS syndrome. Tr. 22, 50. Dr. Latov described
POEMS syndrome as a plasma cell disorder of unknown etiology. Tr. 58-59.
Traditionally, the disorder is accompanied by a slowly progressive, demyelinating neuropathy
associated with a lambda monoclonal gammopathy and increased serum levels of VEGF. Tr. 23-
24, 55; Pet. Ex. 29 at 7. The diagnostic criteria for the disease require a combination of
8 In addition to IVIG, Dr. Latov noted that petitioner received a dose of Solu-medrol, a steroid
treatment not typically used to treat GBS. Tr. 16. He suspected that R.S. received this treatment
for her neuropathy-related pain. Id.
9 L. Ruts et al., Distinguishing Acute-Onset CIDP From Fluctuating Guillain-Barré Syndrome: A
Prospective Study, 74 Neurol. 1680 (2010).
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neuropathy, monoclonal gammopathy, and elevated VEGF, or the presence of Castleman’s
disease. Tr. 23, 58; see Pet. Ex. 29, Tab F at 214. Other systemic manifestations can include
fluid overload, ascites or papilledema, intercranial pressure, skin changes, and endocrine
abnormalities. Tr. 23. Dr. Latov posited that patients with POEMS are typically treated with
Revlimid or lenalidomide. Tr. 25.
Consistent with petitioner’s treating physicians, Dr. Latov agreed that R.S. met the
diagnostic criteria for a POEMS syndrome diagnosis by July or August 2014. Tr. 24, 50. In
reference to the medical record, Dr. Latov recalled that petitioner presented with a small IgA,
lambda monoclonal gammopathy in February 2014. Tr. 24. She thereafter developed
papilledema, and was found to have elevated serum VEGF levels in August 2014. Tr. 24, 50.
Based on his interpretation of the medical records, Dr. Latov posited that R.S. developed
two separate disease processes over the course of her illness: GBS and POEMS syndrome. Tr.
23; Pet. Ex. 38 at 2. At the same time, Dr. Latov explained that petitioner’s GBS evolved into
CIDP and then POEMS, resulting in some overlap in the conditions. Tr. 23 (“she probably had
POEMS syndrome and CIDP concurrently”) 33, 61. Given the accompanying neuropathy that is
typically associated with GBS/CIDP and POEMS syndrome, Dr. Latov opined that the diseases
are difficult to distinguish clinically at onset.
Despite the similarities, Dr. Latov adamantly maintained that R.S.’s initial symptoms in
October and November 2013 were not evidence of an onset of POEMS. Tr. 35, 52, 54-55, 69;
Pet. Ex. 29 at 9. In so stating, Dr. Latov dismissed opinions from petitioner’s later-in- time
treating physicians who placed her onset of POEMS syndrome in October 2013 close-in- time to
her initial neuropathy and eruption of cherry angiomas. Tr. 46-47, 49. Rather, he maintained that
the first manifestation of POEMS syndrome occurred in July/August 2014 when R.S.
experienced increased cranial pressure/papilledema, and her bloodwork indicated an increase in
serum VEGF levels and the presence of monoclonal gammopathy. Tr. 55-56, 85.
Dr. Latov next discussed the medical record evidence he deemed supportive of his
opinion that R.S.’s initial neuropathy-related symptoms, beginning in October 2013, were
indicative of GBS as opposed to POEMS syndrome. Dr. Latov opined that a neuropathy
associated with POEMS syndrome is typically chronic or subacute in nature and nonresponsive
to treatment with IVIG therapy. Tr. 24-25, 35. In contrast, a neuropathy associated with GBS is
acute, or rapidly progressive, and responds well to IVIG. Tr. 57-58.
In R.S.’s case, Dr. Latov concluded that her initial neuropathy was best attributable to
GBS given the rapid progression of symptoms and her positive response to IVIG therapy. In
support, Dr. Latov referenced instances in the medical records where petitioner’s treaters
reported an improvement in muscle strength over the course of her hospital admissions. He
maintained on cross examination that R.S.’s response to IVIG as a whole, or over the course of
her three hospitalizations, was consistent over the active course of her GBS and the related
relapses, despite some suggestion by respondent that the treatment gradually became less robust.
Tr. 36.
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On cross examination, Dr. Latov was questioned further regarding the effectiveness of
IVIG and plasmapheresis in patients with POEMS syndrome. Tr. 36. For instance, respondent
offered a study authored by Dr. Latov, and submitted into evidence by petitioner, which reports
that patients with monoclonal gammopathy can experience some clinical improvement following
IVIG and plasmapheresis therapy. Tr. 36-37; see Pet. Ex. 29, Tab H.10 Dr. Latov acknowledged
the study, but maintained that neuropathies associated with POEMS syndrome do not respond
well to IVIG treatment. Tr. 37-38, 39. He explained that treatment effectiveness depends on the
type of monoclonal gammopathy experienced and the underlying disease process associated with
its occurrence. Id. For example, monoclonal gammopathies related to GBS or CIDP will
respond well to IVIG, whereas classic POEMS does not. Tr. 36-37, 38-39. In support, Dr. Latov
cited to case reports of POEMS patients reporting an improvement in GBS-related symptoms
following treatment with IVIG. See, e.g., Pet. Ex. 29, Tab Q;11 Resp. Ex. A, Tab 10;12 Resp. Ex.
A, Tab 6.13
In addition to her initial neuropathy, Dr. Latov recalled that petitioner experienced cranial
nerve symptoms, such as drooling, during her first hospital admission. Tr. 24, 76, 85. Based on
his review of the literature, Dr. Latov opined that cranial nerve involvement is not typically
associated with POEMS syndrome. Tr. 24-25. He estimated that older POEMS literature
identifies cranial nerve involvement as a presenting symptom in one percent of cases. Tr. 59-60.
He further reported that updated literature discussing POEMS syndrome does not implicate the
cranial nerve. Tr. 59, 76-77; see Resp. Ex. A, Tab 6 at 678. GBS, on the other hand, is more
often associated with the cranial nerve. Tr. 14, 24, 55, 76. Dr. Latov thus concluded that
petitioner cranial nerve symptoms were likely attributable to GBS. Tr. 55, 76.
Dr. Latov downplayed the significance of R.S.’s cherry angioma eruption, occurring
simultaneous with her neuropathy. Tr. 47, 61. At hearing, he estimated that fifty percent of the
population experiences cherry angiomas, a condition which is routinely unrelated to some
underlying disease process. Tr. 47, 61; see Pet. Ex. 31, Tab R at 905. Dr. Latov further posited
that POEMS syndrome is associated with “glomerulus angioma[,]” which petitioner did not
have. Tr. 47, 63-64; see Pet. Ex. 31, Tab N at 1349.14 Given the prevalence of angiomas,
10 Norman Latov, Pathogenesis and Therapy of Neuropathies Associated with Monoclonal
Gammopathies, 37 Ann. Neurol. S32 (1995).
11 Monika Sojka et al., Guillain-Barré Syndrome as the First Manifestation of POEMS
Syndrome, 46 Neurologia i Neurochirurgia Polska 284 (2012).
12 Ju-Hong Min et al., POEMS Syndrome Presenting with Acute Demyelinating Polyneuropathy:
Increased Terminal Latency Indices and Uniform Demyelination, 52 Intern. Med. 1513 (2013).
13 S. Isose et al., POEMS Syndrome with Guillain-Barré Syndrome-Like Acute Onset: A Case
Report and Review of Neurological Progression in 30 Cases, 82 J. Neurol. Neurosurg. Psychiatry
678 (2010).
14 Rachel Miest et al., Cutaneous Manifestations in Patients with POEMS Syndrome, 52 Int’l J.
Dermatol. 1349 (2013).
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Dr. Latov could not conclude that this symptom more likely than not supported a finding of an
onset of POEMS in October/November 2013. Tr. 47-48.
To further distinguish between R.S.’s initial GBS diagnosis and her development of
POEMS syndrome, Dr. Latov spent some time at hearing discussing the relevance of
petitioner’s SPEP test results. Tr. 43-44. R.S.’s initial SPEP test, conducted in November 2013,
was negative for the monoclonal protein, a finding that suggested petitioner did not have
POEMS around that time period. Tr. 43 (“serum protein electrophoresis was negative without an
M protein”); see Pet. Ex. 7 at 600. On cross examination, however, Dr. Latov agreed that a small
number of POEMS patients can present with normal SPEP. Tr. 43-44, 85-86. He further
acknowledged that the SPEP test petitioner received in early November 2013 was conducted
without immunofixation, the preferred method to test for monoclonal gammopathy. Tr. 43.
On cross examination, respondent questioned Dr. Latov regarding the significance of
R.S.’s persistent thrombocytosis and its relationship to her POEMS syndrome diagnosis. Tr.
44. Dr. Latov agreed that thrombocytosis can be a presenting symptom in both GBS and
POEMS. Id. He estimated that fifty percent of patients with an inflammatory condition
experience thrombocytosis. Id. Once the inflammation is treated, the platelet count returns to
normal in most cases. Id. Dr. Latov acknowledged that R.S. presented with an elevated platelet
count during her first hospitalization for neuropathy symptoms in November 2013, which
progressed through 2014. Tr. 45. He could not recall if petitioner’s count improved following
her treatment for POEMS syndrome. Id.
Dr. Latov next proposed a medical theory of causation by which the flu vaccine caused
R.S. to develop GBS, and thereafter, POEMS syndrome: the biologic process of molecular
mimicry accompanied by chronic immune stimulation. Tr. 26. Dr. Latov’s testimony on
molecular mimicry theory revolved around a concept that has largely been accepted in the
medical community, and often in the Vaccine Program, as a causal mechanism for a flu vaccine-
induced GBS injury. In short, Dr. Latov proposed that antibodies produced to fight off a foreign
antigen/infection or generated in response to a vaccine can mistakenly attack, or cross-react with
the myelin basic protein, a primary component of the human nerves. Tr. 26-27. As a result, an
autoimmune process begins, which further promotes the production of these antibodies that then
mistakenly attack the self, thereby causing damages to the nerve’s myelin sheath.15 Tr. 27; see
Pet. Ex. 29, Tab P at 105.16
Dr. Latov acknowledged at the hearing that he is not proposing that the flu vaccine
caused petitioner’s POEMS syndrome. Tr. 55, 72-73. But rather, as noted earlier, he theorized
that petitioner’s POEMS syndrome was a direct result of GBS, which he deems vaccine-induced,
15 At hearing, Dr. Latov briefly referenced the concept of bystander activation as a possible
mechanism by which the flu vaccine could initiate an autoimmune reaction via autoreactive
immune cells (produced secondarily to those responding to the foreign antigen). Tr. 26; see Pet.
Ex. 29 at 8.
16 Lawrence Schonberger et al., Guillain-Barré Syndrome Following Vaccination in the National
Influenza Immunization Program, United States, 1976-1977, 110 Am. J. Epidemiol. 105 (1979).
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a theory he acknowledged has not been described in the medical literature to date as an
established mechanism for pathogenesis. Tr. 33, 54, 56-57. To causally connect plasma cell
disorders or plasma cell “dyscrasia” to GBS, Dr. Latov posited that an over-production of plasma
cells is thought to be secondary to the chronic stimulation of B-cells which resulted from
petitioner’s GBS. Tr. 33, 50-51. When asked to describe how GBS could trigger POEMS, Dr.
Latov stated that “if the monoclonal gammopathy happens to be lambda light chain and
associated with [] the VEGF and the other cytokines, it can by chance, become POEMS.” Tr. 31.
Dr. Latov posited that while chronic stimulation is necessary to initiate POEMS, the monoclonal
gammopathy can self-perpetuate once its “in place” without further immune stimulation. Tr. 67.
Dr. Latov’s testimony regarding the role of cytokines in his theory was vague. He
explained that proinflammatory cytokines are produced by the immune system in response to a
foreign antigen invasion. Tr. 32. Dr. Latov could not recall if cytokines are pathologically
associated with the onset of GBS, but he theorized that the IL-6 cytokine may induce abnormal
levels of VEGF which is related to POEMS syndrome. Tr. 32, 59. Despite these assertions, Dr.
Latov did not cite to any studies supporting a theory that cytokines can result in elevated serum
levels of VEGF. Tr. 32. He also acknowledged that anti-cytokine agents do not ameliorate the
clinical manifestations of POEMS syndrome. Id.
At hearing, Dr. Latov discussed multiple medical articles that he stated supported his
theory that a plasma cell disorder, such as POEMS syndrome, could result from the chronic
inflammation produced secondary to GBS. Tr. 28. First, Dr. Latov referenced the Di Troia
article. Id.; see Pet. Ex. 29, Tab E.17 The Di Troia article correlated the clinical and
electrophysical features of neuropathy with the duration and anti-neural activity of the M-protein
in seventeen patients to determine the pathogenic relevance of an IgG monoclonal gammopathy.
Pet. Ex. 29, Tab E at 64. Dr. Latov posited that the Di Troia study is relevant to the present
matter because it shows that a monoclonal gammopathy can occur simultaneous with a
neuropathy. Tr. 28, 81. Indeed, the authors of Di Troia reported that all patients included in the
study were diagnosed with a neuropathy prior to onset of a monoclonal gammopathy. Pet. Ex.
29, Tab E at 66. They concluded, however, that the “pathogenic relevance of this association is .
. . unknown.” Id. at 70. Dr. Latov acknowledged this conclusion at hearing, and agreed that
further investigation is needed to determine how the two disease processes are related. Tr. 66.
Dr. Latov next discussed the McShane article. Tr. 29-30; see Pet. Ex. 31, Tab M.18 The
McShane article catalogs the current literature undertaken to evaluate the strength of evidence
linking autoimmune disease with an elevated risk of monoclonal gammopathy and multiple
myeloma. Pet. Ex. 31, Tab M at 332. Dr. Latov posited that researchers in McShane found an
elevated risk of both monoclonal gammopathy and multiple myeloma in the presence of
autoimmune disease. Tr. 29. Notably, however, researchers in McShane could not identify a
17 A. Di Troia et al., Clinical Features and Anti-Neural Reactivity in Neuropathy Associated with
IgG Monoclonal Gammopathy of Undetermined Significance, 164 J. Neurol. Sci. 64 (1999).
18 Charlene McShane et al., Prior Autoimmune Disease and Risk of Monoclonal Gammopathy of
Undetermined Significance and Multiple Myeloma: A Systemic Review, 23 Cancer Epidemiol.
Biomarkers Prev. 332 (2014).
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specific causal relationship between any autoimmune disease and the development of a
monoclonal gammopathy or multiple myeloma. Pet. Ex. 31, Tab M at 335, 340. The article thus
concludes only that the two conditions “may be of autoimmune origin” and that “immune-based
biomarkers may be useful in predicting disease onset and progression.” Id. at 340.
Finally, Dr. Latov referenced the Soderberg study. Tr. 30; see Pet. Ex. 31, Tab W.19 Dr.
Latov posited that the authors in Soderberg concluded that chronic autoimmunity and immune
stimulation could contribute to the development of hematological malignancies or myeloma. Tr.
30. Indeed, Soderberg studied roughly 40,000 cases of leukemia, Hodgkin’s disease, non-
Hodgkin’s lymphoma, and myeloma in Sweden during 1987-1999 to investigate potential
associations between several autoimmune diseases. Pet. Ex. 31, Tab W at 3028. Researchers in
Soderberg found an elevated risk of malignancy in autoimmune haemolytic anemia and
idiopathic thrombocytopenic purpura. Id. They theorized that chronic autoimmunity or immune
stimulation induced by activated immune cells could lead to random mutation in dividing cells.
Id. at 3028. Although petitioner in the present matter was not diagnosed with a preceding
autoimmune disorder, Dr. Latov maintained that the Soderberg article supported his opinion
given that monoclonal gammopathies are thought to precede the development of myeloma. Tr.
31.
All in all, Dr. Latov agreed that there is “no proof” that GBS/CIDP can contribute to the
development of POEMS syndrome, but he continued to maintain that evidence of a temporal
relationship between the two suggests petitioner’s POEMS could be due to chronic immune
stimulation. Tr. 30. Given the rarity of the disease, Dr. Latov acknowledged that he knew of no
study detailing any direct relationship between GBS/CIDP and POEMS. Tr. 40. Dr. Latov thus
relied upon case reports to establish a causal link between GBS and/or CIDP and POEMS
syndrome. Id.
The first case report cited by Dr. Latov was the Sojka case report. See Pet. Ex. 29, Tab Q.
On cross examination, respondent maintained that the Sojka case report described a patient who
presented with GBS-like symptoms, but ultimately received a POEMS diagnosis following
testing which confirmed the presence of the monoclonal protein. Tr. 40-42; Pet. Ex. 29, Tab Q at
284. Respondent posited that the patient was diagnosed with GBS at onset due to the similarity
in neuropathy-related features as well as the initial negative testing for the monoclonal protein.
Tr. 40-42. Dr. Latov proposed, however, that the patient likely had GBS initially and developed
POEMS months later, consistent with his theory that the chronic inflammation associated with
GBS can result in POEMS. Tr. 42.
Dr. Latov also commented on the Isose article, a case report and review of thirty POEMS
cases. Tr. 74; see Resp. Ex. A, Tab 6 at 678. The case report discussed in Isose describes a
patient who presented initially with acute neuropathy symptoms thought to be related to GBS
and then CIDP following a six-week progression of symptoms. Resp. Ex. A, Tab 6 at 678. A
laboratory examination conducted around six weeks after onset was positive for monoclonal
gammopathy. Id. The patient was thereafter diagnosed with POEMS around eight weeks
19 Karin Soderberg et al., Autoimmune Diseases, Asthma and Risk of Hematological
Malignancies: A Nationwide Case-Control Study in Sweden, 42 Eur. J. Cancer 3028 (2006).
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following the onset of her neuropathy after additional laboratory results revealed elevated serum
VEFG levels. Id. Dr. Latov maintained that the patient described in Isose suffered from GBS
and POEMS “concurrently[,]” as the POEMS syndrome diagnosis occurred multiple weeks after
the neurological abnormalities were recorded. Tr. 74.
As to the timing of onset of R.S.’s illness, Dr. Latov maintained that she experienced her
first symptom of GBS two weeks post vaccination. Tr. 33. In his view, a two- week onset falls
within an appropriate timeframe for an immune-mediated injury caused by a vaccine. Id. For
support, Dr. Latov relied primarily on the flu/GBS epidemiologic evidence in the Schonberger
study. As discussed earlier, researchers in Schonberger studied the incidence of onset of GBS
following the swine flu vaccine, concluding that an increase in disease frequency occurred
mostly within a five-week week period thereafter. Pet. Ex. 29, Tab P at 105.
To conclude, Dr. Latov briefly addressed evidence in the record suggesting R.S. suffered
from some gastrointestinal infection three days following her receipt of the flu vaccine in
October 2013. Tr. 70. Dr. Latov acknowledged that prior infection can be a precursor illness to
GBS, but he felt petitioner’s illness was too mild to be causal given that she did not experience
accompanying systemic manifestations such as a fever. Tr. 70-71. Even so, Dr. Latov theorized
that a pre-existing gastrointestinal infection, coupled with a vaccination, could combine to trigger
GBS. Tr. 71.
ii. Samir Parekh, M.D.
Dr. Parekh served as petitioner’s second testifying expert. He offered one expert report
in support of her claim. See Pet. Ex. 57. Consistent with Dr. Latov, Dr. Parekh offered the
opinion that R.S. initially presented with GBS in November 2013, and that chronic immune
stimulation produced secondarily to GBS caused R.S. to develop POEMS syndrome thereafter
in August 2014. Tr. 225, 249-50, 251.
Dr. Parekh received his medical degree from the K.J. Somaiya Medical College at the
University of Bombay in India. Tr. 213. After medical school, Dr. Parekh completed an
internship and residency in internal medicine at Rush University in Chicago, Illinois. Id. He
thereafter completed a clinical and research fellowship in hematology and medical oncology at
Albert Einstein College of Medicine in New York. Id. In his clinical fellowship, Dr. Parekh
treated patients with a variety of cancer and non-cancer hematological diseases. Id. He trained
specifically in bone marrow transplantation. Tr. 214.
Dr. Parekh is board certified in internal medicine and hematology. Tr. 214. Following
his university training, he worked as an Assistant Professor at the Albert Einstein College of
Medicine from 2003 to 2013. Id. At present, he serves as an Associate Professor of Hematology
and Oncology, with a secondary appointment in oncological sciences within the graduate school,
at the Icahn School of Medicine at Mount Sinai Medical Center. Tr. 215. As part of his research
duties, Dr. Parekh studies the genomics of multiple myeloma. Tr. 216-17. His lab work also
includes drug development for myeloma and hematological malignances. Id. Dr. Parekh also
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attends to patients in a clinical setting, focusing on hematological malignances and myelomas.
Id. He has treated and diagnosed individuals with POEMS syndrome. Tr. 219.20
Dr. Parekh’s opinion largely mirrored Dr. Latov’s although Dr. Parekh delved further
into the debate regarding the proper diagnosis of petitioner’s symptoms, whether GBS and
POEMS, or solely POEMS. Dr. Parekh began by discussing the underlying components of
plasma cell dyscrasias. Tr. 223. He defined plasma cell dyscrasias as a spectrum of diseases
caused by an over production of abnormal plasma cells clones. Id. Dr. Parekh explained that
healthy individuals produce plasma cells, a type of disease-fighting white blood cell, which make
antibodies against the various foreign antigens entering the body. Id. In patients with plasma
cell dyscrasia, the plasma cell starts reproducing uncontrollably, making copies of itself and
producing an excess of the antibody or immunoglobulin. Id. The most common plasma cell
disorder is the monoclonal gammopathy of unknown significance or “MGUS[,]” a term used to
describe a patient that has an abnormal blood test showing a protein of clonal nature. Tr. 224.
As the plasma cells continue to grow in excess, they can result in low blood counts, kidney
failure, bone lesions, or in severe cases, active myeloma. Tr. 224-25.
Dr. Parekh next discussed the four diagnostic criteria for a POEMS syndrome diagnosis,
as described in the Dispenzieri article. Tr. 225; Pet. Ex. 57 at 3; see Pet. Ex. 29, Tab F at 215.
The Dispenzieri article categorizes the two main criteria as monoclonal plasma cell disorder and
neuropathy. Tr. 226. The third criteria for POEMS syndrome must consist of one of the
following: elevated VEGF, the presence of Castleman’s disease, or sclerotic lesions. Id. The
final criteria encompass multiple “minor criteria” and can include organomegaly,
endocrinopathy, skin changes, papilledema, thrombocytosis, and others. Tr. 226-27.
Based on his review of what he deemed the appropriate clinical criteria, Dr. Parekh
opined that R.S. had been correctly diagnosed with POEMS syndrome. Tr. 227. As he
explained, she presented with a polyneuropathy in 2013 and thereafter developed a monoclonal
plasma cell disorder, elevated VEGF, raised intracranial tension, and papilledema. Id. In his
assessment of the contemporaneous medical record, Dr. Parekh’s discussion of R.S.’s clinical
course focused primarily on the hematologic aspects of the disease. He mostly deferred to Dr.
Latov to explain the significance of her polyneuropathy and presumed GBS diagnosis in
November 2013, but he did offer some testimony regarding her early symptoms. Id.
Dr. Parekh maintained that R.S.’s initial neuropathy symptoms were more consistent
with a GBS. Tr. 246-47. In support, Dr. Parekh posited that petitioner experienced a neuropathy
characterized by “ascending neurological deficit[,]” which he considered more indicative of
GBS. Tr. 247. Dr. Parekh also referenced petitioner’s cranial nerve involvement (i.e., drooling),
occurring at initial onset. Dr. Parekh testified that patients with POEMS syndrome typically do
not experience symptoms indicative of cranial nerve disfunction. Tr. 231. He otherwise deemed
the symptom to be neurological in nature and deferred to Dr. Latov’s interpretation regarding its
significance. Id. Dr. Parekh also noted that multiple of R.S.’s treaters assessed her with GBS and
associated the condition with the flu vaccine. Tr. 242-43.
20 On cross examination, Dr. Parekh confirmed that he does not diagnose patients with GBS. Tr.
242.
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Dr. Parekh also briefly referenced petitioner’s initial response to IVIG therapy following
her hospital presentation for neuropathy symptoms. Tr. 247; Pet. Ex. 57 at 3. Consistent with
Dr. Latov, he posited that a positive response to IVIG would be consistent with a GBS
neuropathy. Tr. 247. Dr. Parekh acknowledged on cross examination, however, that he was
aware of case reports showing patients with POEMS syndrome can respond well to IVIG
therapy. Id.
Dr. Parekh otherwise discussed at length the evidence in petitioner’s medical record
which he deemed best supportive of an onset of POEMS syndrome. He began by explaining the
significance of Ms. Saver’s SPEP tests in relation to her development of a monoclonal
gammopathy. Tr. 227. Consistent with the medical record, Dr. Parekh noted that R.S.’s initial
SPEP test, conducted without immunofixation, in November 2013 was negative for M- protein.
Tr. 228, 248-49; see Pet. Ex. 5 at 826. A second SPEP test from February 2014 revealed two
IgA lambda M-components of .22 grams per deciliter and .06 grams per deciliter, respectively,
in the beta region. Tr. 228, 248-49. Based on his reading of R.S.’s February 2014 test, Dr.
Parekh posited that she had an abnormal plasma clone at that time. Tr. 228, 249; see Pet. Ex. 57
at 5.
By August 2014, R.S. had elevated VEGF, thereby satisfying the third clinical criteria of
POEMS syndrome. Tr. 228. Petitioner also underwent a bone marrow biopsy in mid- August,
showing a small clonal IgA-positive plasma cell population in the marrow. Tr. 228-29; see Pet.
Ex. 18 at 1049. As Dr. Parekh explained, healthy individuals have up to five percent of
polyclonal plasma cells, that is cells having both kappa and lambda light chains. Tr. 229-30.
R.S.’s biopsy results revealed an abnormal lambda light chain restriction in five percent of her
cells, which further supported a finding of monoclonal gammopathy. Tr. 230.
On cross examination, Dr. Parekh discussed the relevancy of petitioner’s active
thrombocytosis and its relationship to POEMS syndrome. Tr. 244-46. As noted earlier, R.S.
presented with elevated platelet levels during her initial hospitalization in November 2013. Tr.
244. Dr. Parekh acknowledged this symptom, but categorized the findings as nonspecific in the
context of a POEMS diagnosis. Tr. 244-45; see also Pet. Ex. 57 at 4-5. As he explained,
thrombocytosis is a common occurrence in response to unspecified inflammation, infection, or
iron deficiency/anemia. Tr. 245-46. Concerning POEMS syndrome, he agreed that
thrombocytosis could be a minor finding associated with the illness. Tr. 246.21 Dr. Parekh
maintained, however, that elevated platelets are not specific enough to diagnosis a patient with
POEMS. Id.
Based on the findings discussed above, Dr. Parekh opined that R.S. met the diagnostic
criteria for POEMS in or around August 2014. Tr. 231, 249-50. Once diagnosed, she started
Revlimid, along with dexamethasone for four cycles, followed by an autologous stem cell
transplant, and responded well to both therapies (i.e., her VEGF levels decreased). Tr. 232.
Along those same lines, Dr. Parekh acknowledged that R.S. responded somewhat to IVIG
21 Dr. Parekh also agreed that R.S.’s thrombocytosis remained persistent throughout her illness
and resolved following treatment for POEMS. Tr. 245-46.
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therapy in the early stages of her illness. Id. In his clinical experience, however, Dr. Parekh
explained that IVIG is not the typical treatment of choice for POEMS syndrome, given that IVIG
is not directed at eradicating the plasma cell clone. Id. Nonetheless, Dr. Parekh acknowledged
that POEMS may respond to IVIG is some instances. Id. (“there are anecdotal examples where
POEMS may respond”).
Dr. Parekh next offered his own interpretation of the medical theory of causation
applicable herein. Consistent with Dr. Latov, Dr. Parekh opined that the chronic immune
stimulation, resulting secondarily from a GBS diagnosis, caused R.S. to develop an
overabundance of plasma cells, which in turn led to her onset of POEMS syndrome. Tr. 232,
240-41. To connect chronic immune stimulation and plasma cell dyscrasia, Dr. Parekh began by
explaining how plasma cells develop in the body. Tr. 232-33. Plasma cells originate as
immature B cells in the bone marrow. Id. Following formation, immature B cells are released
into the bloodstream, exposing them to various foreign antigens. Tr. 232-33. B cells then enter
the lymph nodes, where they undergo several rounds of a maturation process called high affinity
antibody selection to learn how to make antibodies to a particular antigen. Tr. 233. The
maturation process produces two types of cells: plasma cells and memory B cells. Id. The
remaining cells are deleted from the system via apoptosis. Id.
Along those same lines, Dr. Parekh posited that antigens can also be important in the
developed of plasma cell proliferation. Tr. 233. In reference to the maturation process discussed
above, Dr. Parekh opined that B cells, when presented to an antigen, can become “malignant and
undergo monoclonal expansion near the population of expanded cells.” Tr. 235. For support,
Dr. Parekh referenced the Nair article. Id. at 233-34, 312-13; see Pet. Ex. 61.22 Nair examined
the clonal immunoglobulin in Gaucher’s patients and in mouse models of Gaucher’s disease-
associated gammopathies to determine if long-term immune activation could stimulate the
monoclonal gammopathy associated with the disease.23 Tr. 234. Researchers in Nair determined
that the monoclonal protein underlying the disease-associated gammopathy is specific for certain
lysolipids (LGLI and LPC). Id.; see Pet. Ex. 61 at 555. Taken together, Dr. Parekh posited that
these proteins could cause the body to develop an overabundance of plasma cells. Tr. 234.
Researchers in the same study also conducted experimental mouse models and determined that
Gaucher’s medication could reduce the effect of monoclonal protein spikes in gammopathy
patients. Id. Dr. Parekh suggested that this finding further supported his suspicion that removing
“the antigen” causes plasma cell proliferation to resolve. Id.
Dr. Parekh also suggested that cytokines, specifically the IL-6 variant, can stimulate
plasma cell growth. Tr. 235. Dr. Parekh referenced the Rush article in support of this assertion.
Tr. 235-36. In Rush, researchers conducted a mouse model study to determine if IL-6 can cause
plasma cell dyscrasia. Tr. 236. As part of their experiment, the authors genetically engineered
mice to overexpress IL-6 and determined that mice injected with the substance developed an
22 Shiny Nair et al., Clonal Immunoglobulin Against Lysolipids in the Origin of Myeloma, 374
New Eng. J. Med. 555 (2016).
23 Dr. Parekh defined Gaucher’s disease as an inborn error of metabolism where patients are
deficient in a particular enzyme. Tr. 234.
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increase in plasma cells and tumors. Id. Dr. Parekh posited that cytokines can also stimulate an
overgrowth of myeloma cells, as well as further cytokine expansion, resulting in a “vicious circle
of self-perpetuating growth.” Tr. 236-37. Dr. Parekh explained that VEGF, an element strongly
considered to be pivotal to the pathogenesis of POEMS syndrome, is a cytokine secreted by
plasma cells that causes blood vessel leakage. Tr. 237, 311-12; see Pet. Ex. 29, Tab F at 215.
Dr. Parekh next went on to discuss the mineral oil plasmacytoma model or “MOPC[,]” an
experimental mouse model he deemed instrumental in studying the development of plasma cell
disorders. Tr. 238-39; see Pet. Ex. 68;24 Pet. Ex. 60.25 The Potter article indicates that the
mineral oil, pristane, can stimulate plasma cell growth in mice by irritating the peritoneal cavity.
Tr. 238; see Pet. Ex. 68 at 18, 28-31. Similarly, researchers in Hofgaard used the same technique
to test a multiple myeloma model suitable for studying bone marrow tropism, development of
osteolytic lesions, drug testing, and immunotherapy. Pet. Ex. 60 at e51892. According to Dr.
Parekh, these two studies support his opinion that a “chronic irritating stimulus can cause
inflammation leading to plasma cell dyscrasia.” Tr. 238-39.
Finally, Dr. Parekh referenced the Lindqvist epidemiologic study. Tr. 239; Pet. Ex. 59.
Lindqvist is a case-controlled study of both monoclonal gammopathy (21,0000 controls/5,000
diagnoses) and myeloma patients (75,000 controls/19,0000 diagnoses), which analyzed the
relationship between autoimmune disease and risk of developing plasma cell dyscrasia. Pet. Ex.
59 at 6284. Dr. Parekh referenced table two in the article, which lists multiple autoimmune
conditions including GBS, as possibly associated with both monoclonal gammopathy and
multiple myeloma. Id. at 6286. The article reports that 6/8 patients developed GBS following
onset of a monoclonal gammopathy. Id. Dr. Parekh understood this study to support “an
increased risk of developing [monoclonal gammopathy] of almost three-fold.” Tr. 239, 252-53.
Notably, the article does not discuss the relationship between autoimmune disease and POEMS
syndrome. Tr. 253.
Apart from the articles referenced above, Dr. Parekh could not recall any medical
literature or evidence to suggest that GBS can be a precursor illness to POEMS, or any other
literature directly connecting GBS to POEMS syndrome. Tr. 251.
iii. Brea Lipe, M.D.
Respondent’s first expert, Dr. Lipe, prepared two expert reports and testified at hearing.
See Resp. Exs. C, E. She proposed that R.S. was properly diagnosed with POEMS syndrome
beginning in October/November 2013 with her initial onset of neuropathy. In addition, Dr. Lipe
posited that the flu vaccine played no role in her development of the condition.
24 Michael Potter, The Early History of Plasma Cell Tumors in Mice, 1954-1976, 98 Advances
Cancer Res. 17 (2007).
25 Peter Hofgaard et al., A Novel Mouse Model for Multiple Myeloma (MOPC315.BM) That
Allows Noninvasive Spatiotemporal Detection of Osteolytic Disease, 7 PolsOne e51892 (2012).
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Dr. Lipe obtained her bachelor’s degree from the University of Colorado. Tr. 255; see
Resp. Ex. D at 1. Thereafter, she attended medical school at Albany Medical College. Tr. 255.
She completed her residency, followed by a fellowship in hematology and oncology at
Dartmouth-Hitchcock Medical Center. Id. She then went on to receive a master’s degree in
clinical research from the University of Kansas. Tr. 255. Dr. Lipe is board-certified in
hematology and internal medicine. Tr. 256. At present, Dr. Lipe serves as an Associate
Professor and the Director of Clinical Myeloma at the University of Rochester, where she treats
patients suffering from a wide range of plasma cell disorders. Tr. 255-56. She also oversees
clinical trials and research on topics including multiple myeloma and monoclonal gammopathies.
Tr. 257. As part of her clinical practice, Dr. Lipe estimated that she has diagnosed roughly ten to
fifteen patients with POEMS syndrome over the course of her career. Tr. 259. She is also part
of a working group with the College of American Pathology that is working to create guidelines
for diagnosing monoclonal gammopathies. Tr. 257.
Dr. Lipe began by discussing POEMS syndrome and the diagnostic criteria relevant to
the condition. Tr. 260. Dr. Lipe defined POEMS syndrome as a hematologic disease of the
plasma cells, or a “plasma cell dyscrasia.” Tr. 263, 289; see also Resp. Ex. C at 3. Consistent
with the testimony offered by petitioner’s experts, Dr. Lipe cited literature discussing the criteria
required for diagnosis, which includes both a polyneuropathy and plasma cell clone or
monoclonal gammopathy, and one of the following: VEGF elevation, sclerotic bone lesions, or
Castleman’s disease. See Resp. Ex. C, Tab 3 at 2496.26 Other minor criteria can include
papilledema, thrombocytosis, skin changes, and organomegaly. Id. Dr. Lipe estimated the
frequency of a POEMS diagnosis to be 1 in 330,000. Tr. 261.
Based on her clinical experience and review of the medical literature, Dr. Lipe opined
that patients with POEMS syndrome typically present with related symptoms nine to sixteen
months prior to diagnosis. Tr. 262; see Resp. Ex. C, Tab 4 at 304. The initial onset of
symptoms, however, can present acutely, causing rapid deterioration within two weeks at the
earliest. Tr. 268. Overall, Dr. Lipe maintained that patients with POEMS syndrome do not
present with every possible symptom all at once. Tr. 287. Rather, over time, POEMS patients
accumulate more of the features of the syndrome. Id.
Dr. Lipe further posited that POEMS syndrome is often times initially misdiagnosed as
CIDP or AIDP, conditions similar to GBS. Tr. 260-61, 282, 293; see Resp. Ex. E at 1. For
support, Dr. Lipe referenced the Nasu and Dispenzieri articles. Tr. 261. Nasu analyzed over one
hundred patients diagnosed with POEMS and CIDP to elucidate the differences in the
neuropathy profiles of both diseases. See Resp. Ex. E, Tab 1 at 476. The authors in Nasu
reported that sixty percent of POEMS syndrome patients were initially diagnosed with CIDP
following an onset of polyneuropathy. Tr. 261; Resp. Ex. E, Tab 1 at 477. Similarly, researchers
in Dispenzieri concluded that eighty-five percent of patients with POEMS syndrome were
commonly misdiagnosed with AIDP or CIDP. Tr. 261; see Resp. Ex. C, Tab 3.
26 Angela Dispenzieri et al., POEMS Syndrome: Definitions and Long-Term Outcome, 101
Blood 2496 (2003).
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Dr. Lipe stated that patients who are initially misdiagnosed are not considered to still be
suffering from GBS/CIDP/AIDP once the POEMS diagnosis is made. Tr. 261. Indeed, Dr. Lipe
reported that she has treated POEMS patients who are misdiagnosed at onset, but none who have
distinct GBS/CIDP either consecutively or simultaneous with POEMS. Tr. 262. She also
testified that she was not aware of any literature or evidence to suggest the conditions are linked
in any way. Id. In so stating, Dr. Lipe offered her own interpretation of the case reports of GBS
followed by onset of POEMS submitted by petitioner’s experts. For instance, Dr. Lipe classified
the Sojka case report as a classic case of misdiagnosis. Tr. 262.
Dr. Lipe next discussed the medical records filed in the present matter in relation to her
opinion regarding petitioner’s onset of POEMS syndrome. Tr. 264. Dr. Lipe posited that R.S.’s
POEMS presentation was typical compared to those she has treated in the past. Tr. 267. In
reference to the medical record, Dr. Lipe stated that petitioner reported to the emergency room
initially with thrombocytosis and neuropathy-related symptoms in late November 2013. Tr. 282.
Her course thereafter continued to deteriorate over an eight-month period. By July and August
2014, VEGF levels were drawn27 and SPEP testing with immunofixation confirmed the presence
of the monoclonal protein. Tr. 284-85. Based on the above, Dr. Lipe did not dispute that R.S.
was officially diagnosed with POEMS syndrome in August 2014. Id. She maintained, however,
that the diagnosis and biologic onset of the condition are two distinct events. Tr. 281.
Given her overall course, Dr. Lipe posited that R.S.’s onset of neuropathy in
October/November 2013 constituted the onset of her POEMS syndrome. Tr. 282; Resp. Ex. C at
4. In support, Dr. Lipe cited to medical literature which differentiated between neuropathies
associated with POEMS from those with GBS/CIDP. Tr. 283; see, e.g., Resp. Ex. C, Tab 4 at
304. Dr. Lipe posited that POEMS-associated neuropathies are routinely accompanied by pain
and edema,28 unlike those attributable to GBS/CIDP. Tr. 284, 293. As Dr. Lipe noted,
petitioner’s records documented initial complaints of pain and lower extremity edema during her
initial hospitalization in November 2013. Id.
Moreover, Dr. Lipe referenced petitioner’s medical visit at the Mayo Clinic, with Dr.
Dispenzieri, as supportive evidence of an onset of POEMS disease in October 2013. Tr. 285.
Indeed, Dr. Dispenzieri placed onset of petitioner’s POEMS in 2013, at which time she
experienced neuropathy-related symptoms, fatigue, and a cherry angioma eruption. Pet. Ex. 19 at
27. As Dr. Lipe recalled, Dr. Dispenzieri did not entertain GBS or CIDP as an alternative or
concurrent diagnosis or cause. Id. Given her knowledge of the disease, Dr. Lipe gave Dr.
Dispenzieri’s opinion a great deal of weight when formulating her opinion. Id. (“[Dr.
Dispenzieri] is probably the world’s expert in diagnosis of POEMS” in the United States.).
27 On redirect examination, Dr. Lipe stated that there is no way to determine how long R.S.’s
VEGF was elevated prior to August 2014. Tr. 314. Had the VEGF test been conducted in
November 2013, Dr. Lipe speculated that it would have been positive at that time. Tr. 315.
28 Dr. Lipe posited that edema is a postulated mechanism by which POEMS patients develop
neuropathy. Tr. 315.
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Next, Dr. Lipe discussed petitioner’s thrombocytosis diagnosis and its relevance to her
condition. Tr. 265-66. In general, Dr. Lipe agreed that thrombocytosis can be a nonspecific
finding when taken in isolation. Tr. 266. In R.S.’s case, however, Dr. Lipe attributed her onset of
thrombocytosis in November 2013, and overall persistence through August 2014, to POEMS
syndrome. Tr. 266. Dr. Lipe posited that transient or reactive-type thrombocytosis would resolve
on its own over time. Thrombocytosis attributable to POEMS syndrome, however, would not
improve until the patient’s underlying plasma cell disorder was treated. Id. Consistent with the
medical records filed herein, Dr. Lipe noted that R.S.’s thrombocytosis did not improve until her
physicians definitively treated her for POEMS in 2014. Tr. 266-67; see Resp. Ex. E at 1-2.
Dr. Lipe also posited that petitioner’s subsequent development of an abnormal increase in
cherry angiomas in mid-2014 was attributable to POEMS syndrome. Tr. 286; see Pet. Ex. 3 at 5,
12, 16. Dr. Lipe acknowledged that petitioner may have had some history of cherry angiomas
prior to her onset of the disease, which she deemed unrelated to the condition. Tr. 286-88. The
increase to two angiomas in April 2014 and seven in May 2014, however, would be consistent
with angiomas related to POEMS syndrome. Tr. 287-88.
Consistent with the testimony offered by petitioner’s experts, Dr. Lipe opined that cranial
nerve involvement or facial nerve involvement (i.e., drooling) is not typically seen in POEMS
syndrome. Tr. 267. Dr. Lipe could not recall treating a patient with facial nerve symptoms
specifically. Id. In her own clinical practice, Dr. Lipe stated that she has treated POEMS
patients who experienced pulmonary and swallowing difficulties. Tr. 267. Based on her clinical
experience, Dr. Lipe posited that petitioner’s initial respiratory complaints were best attributable
to POEMS syndrome. Tr. 267. She could not, however, definitively relate petitioner’s drooling
to POEMS given the lack of support relating facial nerve symptoms to the condition. Id.
Dr. Lipe next offered her interpretation of petitioner’s SPEP testing over the course of her
illness. Tr. 268. As discussed by petitioner’s experts on direct examination, R.S.’s initial SPEP
testing from November 2013 was negative for M-protein. Tr. 268. As Dr. Lipe noted, however,
the initial test did not include immunofixation, the method by which the M-protein could be
detected, meaning there was no way of knowing if she had a monoclonal gammopathy at that
time. Tr. 268-69. R.S.’s subsequent SPEP in February 2014, which was conducted with
immunofixation, confirmed the presence of monoclonal protein. Tr. 269.
Given that the 2013 SPEP test was conducted without immunofixation, Dr. Lipe
acknowledged that she could not say for certain if petitioner would have tested positive for
monoclonal protein at that time. Tr. 269. She suspected, however, that if the immunofixation
had been conducted, it likely would have been positive. Tr. 271. Moreover, Dr. Lipe opined that
petitioner’s November 2013 SPEP test revealed an abnormal beta peak. Tr. 270; see Pet. Ex. 5 at
770-71. Dr. Lipe acknowledged that petitioner’s treaters documented the testing as normal, but
she interpreted the abnormal beta spike as a cause for concern. Tr. 270, 305; see Resp. Ex. C,
Tab 9 at 106.29
29 Theodore O’Connell et al., Understanding and Interpreting Serum Protein Electrophoresis, 71
Am. Fam. Physician 105 (2005).
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Dr. Lipe next discussed petitioner’s initial response to IVIG treatment. Tr. 264. Based
on her review of the relevant literature, Dr. Lipe agreed that the majority of patients with
POEMS syndrome do not respond well to IVIG therapy. Id. She noted, however, that there are
case reports where patients do respond to IVIG. Id. In addition, Dr. Lipe posited that the
underlying neuropathy associated with POEMS is traditionally treated with IVIG, thus many
patients can experience an improvement of symptoms initially. Id. In R.S.’s case, Dr.
Lipe agreed that the IVIG therapy she received in late November 2013 and continuing through
early 2014 resulted in some benefit to her condition. Tr. 294. Overall, however, Dr. Lipe
posited that petitioner’s health continued to deteriorate and her physical exams did not improve
to the same degree following subsequent treatment. Id. In her view, the fundamental biology of
her disease did not change based on the treatment course. Id.
Along those same lines, Dr. Lipe opined that petitioner’s initial treatment with Solu-
medrol could have played some role in her resolution of symptoms following her first hospital
admission. Tr. 264, 294; Resp. Ex. E at 2. Dr. Lipe referenced the Dispenzieri article in support,
which indicated that fifty percent of patients with POEMS syndrome respond to steroid therapy.
Tr. 265, 296; see Resp. Ex. C, Tab 3 at 2501. Dr. Lipe acknowledged that R.S.’s initial
improvement was attributed to IVIG, though she felt that it was possible that the Solu-medrol
played a relevant part in her initial improvement. Tr. 265. Moreover, Dr. Lipe noted that
petitioner did not receive steroid treatment during her second and third hospitalizations at which
time her response to treatment was less robust. Id.
Moving forward, Dr. Lipe commented on the medical theory of causation proffered by
petitioner’s experts. Given her understanding of plasma cell biology, Dr. Lipe firmly disagreed
that chronic immune stimulation is an accepted pathogenic mechanism for the development of
plasma cell dyscrasia. Tr. 271, 277; see Resp. Ex. C at 6-7; Resp. Ex. E at 3-4. She knew of no
medical literature or case reports supporting petitioner’s theory that immune stimulation
occurring secondarily due to GBS or CIDP could cause POEMS. Tr. 272.
Overall, Dr. Lipe posited that the literature submitted by petitioner in support of her
theory focused heavily on conditions distinguishable from POEMS. The Lindqvist paper, for
example, analyzed 5,403 patients with monoclonal gammopathy of unknown significance and
multiple myeloma (compared to 21,209 controls) to determine if autoimmune diseases increase
the risk of developing either condition. Tr. 273-75. Dr. Lipe gave little weight to the Lindqvist
paper due to its structure. Tr. 273 (“epidemiologic studies, particularly MGUS, the way this was
done, is particularly problematic”), 298-99. As she explained, monoclonal gammopathies of
unknown significance are asymptomatic; thus, they are only detected once some other disease
process has triggered adverse symptoms. Id. In her review of Lindqvist, Dr. Lipe noted that
selection criteria for the study was limited to monoclonal gammopathy of unknown significance
only, and did not account for any underlying disease process the patients might have experienced
contemporaneously.
Dr. Lipe otherwise categorized any association between monoclonal gammopathy and
GBS to be too speculative. Tr. 275. In support, Dr. Lipe again referenced the Lindqvist study.
Based on their findings, the Lindqvist authors reported that six patients with monoclonal
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gammopathy had concurrent GBS out of roughly 26,000 total case test participants. Tr. 275. Dr.
Lipe agreed that the Lindqvist article reported an elevated odds ratio of GBS in MGUS patients,
but she maintained that such a small number does not suggest evidence of pathogenesis
regarding monoclonal gammopathies. Tr. 276, 297. Moreover, Dr. Lipe critiqued the study for
aggregating results. Tr. 276-77. As she explained, the study broadly concludes that autoimmune
diseases are associated pathologically with monoclonal gammopathies based on multiple
different conditions. Id. In her view, articles like Lindqvist, McShane, Soderberg, and
Shimanovsky (see Pet. Ex. 31, Tab V),30 amount to low statistical significance. Tr. 276-77, 298-
301.
Similarly, Dr. Lipe attributed little weight to the mouse model evidence offered by
petitioner’s experts to support their chronic immune stimulation theory. Tr. 277. Dr. Lipe
posited that the mouse model experimentation, as it relates to monoclonal gammopathies and
multiple myeloma, offered by petitioner does not prove that immune stimulation can cause
plasma cell dyscrasia. Tr. 278. Dr. Lipe explained that monoclonal gammopathies and myeloma
do not occur naturally in mice. Tr. 277-78. Thus, mice populations used in myeloma studies
have been repeatedly inbred, resulting in internal genetic manipulation. Tr. 278. Based on her
review of the studies submitted, Dr. Lipe could not agree that lipid stimulation in mice and a
resulting production of plasma cells supports a conclusion that immune stimulation can cause
myeloma in humans. Tr. 278.
Dr. Lipe also critiqued petitioner’s attempt to relate literature discussing Gaucher’s
disease and onset of monoclonal gammopathies to plasma cell dyscrasia induced by chronic
immune stimulation. Tr. 279. Dr. Lipe agreed with the underlying biology presented in Nair as
explained by petitioner’s experts to show how plasma cells develop in response to foreign
antigens. Tr. 279. As discussed in Nair, researchers studied the capacity of certain lysolipids to
mediate B-cell activation and serve as antigenic targets in Gaucher’s-associated monoclonal
gammopathies. Pet. Ex. 61 at 555, 560. Dr. Lipe found the paper to be helpful in assessing how
best to treat gammopathies associated with the disease. Tr. 279-81. As she explained, lysolipids
associated with Gaucher’s are abnormal proteins produced by abnormal cells. Dr. Lipe thus
stressed that a target antigen is not always pathogenic or causative, meaning that targets as
referenced in Nair could more be symptom-like, occurring as a result of some other mechanism
related to the disease process, but treatable in the long term. Tr. 280. Based on her own review
of the article, Dr. Lipe could not conclude that antigen stimulation could cause a plasma cell
mutation. Tr. 281.
When questioned further regarding her own understanding of POEMS syndrome and its
pathogenesis, Dr. Lipe stated that she could not identify a specific causal mechanism given the
state of the research at present. Tr. 290. Dr. Lipe opined that many researchers believe that
proinflammatory cytokines, IL-1, IL-6, and VEGF in particular, could play some role in the
30 The authors in Shimanovsky reported that patients with preexisting autoimmune conditions
have a higher prevalence of monoclonal gammopathy of undetermined significance and multiple
myeloma. Alexei Shimanovsky et al., Autoimmune Manifestations in Patients with Multiple
Myeloma and Monoclonal Gammopathy of Undetermined Significance, 6 BBA Clinical 12, 12
(2012).
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condition’s development. Tr. 290, 301, 304. For instance, Dr. Lipe referenced the Gherardi
article, which discussed the significance of IL-6 and its relationship to VEGF. Tr. 302-03; see
Resp. Ex. C, Tab 1 at 1458.31 In her review of Gherardi, Dr. Lipe agreed that IL-6 has been
shown to be elevated in plasma cell dyscrasias, but she maintained that researchers do not known
what role, if any, the elevation plays in the context of inflammatory diseases or plasma cell
disorders. Tr. 303-04.
iv. Dennis Bourdette, M.D.
Respondent’s second expert was Dr. Dennis Bourdette. He prepared one expert report
and testified on behalf of respondent at the entitlement hearing. Tr. 88; see Resp. Ex. A.
Consistent with Dr. Lipe, Dr. Bourdette proposed that R.S. was properly diagnosed with
POEMS syndrome with onset in October/November 2013. In so stating, he refuted petitioner’s
assertion that she developed distinct GBS/CIDP in November, followed by POEMS syndrome
the subsequent year. He opined that the flu vaccine petitioner received was unrelated to her
diagnosis. Tr. 93.
Dr. Bourdette obtained his medical degree from the University of California at Davis. Tr.
89; see Resp. Ex. B at 1. He completed his internship at Santa Clara Valley Medical Center,
followed by a three-year neurology residency at the VA Medical Center affiliated with Oregon
Health and Science University (“OHSU”). Tr. 89. Dr. Bourdette is board-certified in neurology
and holds an active medical license in Oregon. Id. He also currently serves as an article
reviewer for the American Academy of Neurology’s main publication, Neurology, as well as
other sub-journals, including Neuroimmunology and Neuroinfection. Tr. 90. Dr. Bourdette has
published over 200 peer-reviewed papers. Tr. 91.
At present, Dr. Bourdette serves as the Chairman of the Department of Neurology at
Oregon Health and Science University. Tr. 89. He also directs the OHSU Multiple Sclerosis
Center and Neuroimmunology Clinic. Id. In his clinical practice, he treats patients with various
neuroimmunological conditions twice per week. Id. His current treatment specialty is Multiple
Sclerosis. Id. at 90, 111.32 Dr. Bourdette has also treated patients with GBS and CIDP over the
course of his career. Tr. 90, 92. In addition, Dr. Bourdette testified that he has diagnosed at least
one patient with POEMS syndrome. Tr. 91, 116-17. Over the years, he has also consulted on
POEMS cases. Tr. 91.
Generally, Dr. Bourdette’s testimony was consistent with Dr. Lipe’s, although Dr.
Bourdette’s opinion focused largely on the debate regarding the proper onset of R.S.’s POEMS
symptoms and any precursor illness she may have experienced. Based on his review of the
accepted clinical criteria for POEMS syndrome, Dr. Bourdette agreed that petitioner was not
officially diagnosed with the disease until early August 2014. Tr. 126-28. Based on his review
31 Romain K. Gherardi et al., Overproduction of Proinflammatory Cytokines Imbalanced by
Their Antagonists in POEMS Syndrome, 87 Blood 1458 (1996).
32 On cross examination, Dr. Bourdette acknowledged that he does not specialize in peripheral
neuropathies. Tr. 111.
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of the medical record, however, Dr. Bourdette opined that petitioner’s subacute inflammatory
neuropathy, which was originally diagnosed as idiopathic GBS, was her first manifestation of
POEMS syndrome.33 Tr. 94-95, 124, 135, 137; Resp. Ex. A at 3-4.
Based on his understanding of the literature, Dr. Bourdette posited that neuropathies
associated with POEMS syndrome can present in both a rapidly progressive or slowly
progressive manner. Tr. 116-18. In support of his opinion, Dr. Bourdette cited to case reports of
patients with established POEMS syndrome, or within a few weeks or months of a neuropathy
clearly had POEMS which was considered to be GBS-like at onset. Tr. 95, 129-31; see, e.g.,
Resp. Ex. A, Tab 10; Resp. Ex. A, Tab 4; Resp. Ex. A, Tab 1.34
In addition, Dr. Bourdette also cited to petitioner’s various treatment records which
analyzed her course retrospectively and placed onset of her illness in October/November 2013.
Tr. 110. Following her POEMS diagnosis, Dr. Bourdette recalled that petitioner presented for an
evaluation at the Mayo Clinic with Dr. Dispenzieri, a physician he deemed to be the world’s
leading expert in POEMS. Id.; see Pet. Ex. 19 at 27. Consistent with his review of petitioner’s
clinical course, Dr. Dispenzieri clearly attributed petitioner’s 2013 neuropathy to POEMS. Tr.
110.
Dr. Bourdette took issue with petitioner’s assertion that she suffered from acute GBS in
November 2013, which then evolved into CIDP thereafter. Tr. 95, 118-19. He posited that
CIDP can present in a variety of ways, including with an initial episode that looks like GBS
initially, followed by a relapse of symptoms. Tr. 95-96, 132. Had petitioner not been diagnosed
with POEMS syndrome, Dr. Bourdette stated that he would have diagnosed her with CIDP in
retrospect, not acute GBS, given the she had an initial neuropathy with sequelae persisting for
over two months. Tr. 96, 123-24. Consistent with Dr. Lipe’s testimony, Dr. Bourdette agreed
that POEMS syndrome can often be misdiagnosed as CIDP given the similarities in the
presenting neurological symptoms. Tr. 98, 103, 118.
Dr. Bourdette also maintained that he knew of no reports of patients experiencing
preexisting GBS/CIDP as a precursory illness, or concurrent CIDP, and POEMS. Tr. 129-31,
132-33, 134-35. In so stating, he refuted petitioner’s assertion that the case report evidence filed
in this case suggests that a POEMS patient can experience distinct GBS/CIDP prior to onset. Tr.
133-34; see, e.g., Pet. Ex. 29, Tab Q. Dr. Bourdette interpreted these case reports to conclude
that POEMS symptoms can manifest with GBS or CIDP-like presentations, but he maintained
that the authors clearly determined the early neurological symptoms were indicative of a POEMS
diagnosis in retrospect. Tr. 134-35.
Dr. Bourdette posited that POEMS syndrome can also manifest as respiratory issues or
lower cranial nerve dysfunction. Tr. 98-99. In support, Dr. Bourdette referenced the Allam
33 Dr. Bourdette relied on the Dispenzieri study to establish the accepted diagnostic criteria for
POEMS. Tr. 125-26; see Pet. Ex. 31, Tab C.
34 A. Abbas et al., A Case of POEMS Mimicking a Guillain-Barré Like Syndrome, 369 J.
Neurol. Sci. 268 (2016).
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article. Tr. 99-100; see Resp. Ex. H.35 The authors in Allam conducted a symptom review of
patients diagnosed with POEMS and found that roughly one third exhibited restrictive
pulmonary function. Tr. 99. Five percent of patients were noted to have pulmonary issues
secondary to the related neuropathy. Id. Furthermore, Dr. Bourdette cited to case report
evidence indicating that speaking difficulties and issues with the lower cranial nerve can be
attributable to POEMS. Tr. 100.
In his review of the medical record, Dr. Bourdette noted that petitioner experienced
symptoms consistent with shortness of breath and voice irregularities/difficulty speaking at her
initial hospital presentation in November 2013. Tr. 98-99. Dr. Bourdette categorized
petitioner’s respiratory problems as related to phrenic nerve dysfunction, while the voice
symptoms were likely due to swallowing issues. Tr. 99. The instances of drooling noted in the
record, Dr. Bourdette admitted, could be indicative of facial paralysis, but he maintained that
those symptoms were likely attributable to swallowing difficulties as well. Id.36 Dr. Bourdette
posited that the lack of specificity in the contemporaneous record made it difficult to determine
how petitioner’s early treaters characterized the drooling abnormality. Tr. 99.
Dr. Bourdette also attributed petitioner’s early diagnosis of thrombocytosis in November
2013 to be related to POEMS. Tr. 104, 119-20, 136-37; Resp. Ex. A at 4. In support, he
referenced literature categorizing thrombocytosis as a minor criteria of the disease. Tr. 104. As
Dr. Bourdette recalled, R.S. presented with elevated platelets counts at her initial hospital
presentation in 2013, which persisted through August 2014 when she was diagnosed with
POEMS. Tr. 104-05. Based on his review of the contemporaneous record, Dr. Bourdette posited
that R.S.’s platelet levels did not return to normal until she was treated for POEMS syndrome.
Tr. 104. He otherwise relied heavily on the opinion of petitioner’s treating hematologists who
related the thrombocytosis to an onset of POEMS syndrome in November 2013 around the time
she also developed the neuropathy. Tr. 104-05. From a neurological standpoint, Dr. Bourdette
opined that persistent thrombocytosis is not indicative of GBS. Tr.
105. He acknowledged that patients with GBS could have an initial rise in platelets levels during
the acute phase of the disease, but any chronic platelet elevation would indicate a hematological
problem. Id.
Consistent with Dr. Lipe, Dr. Bourdette opined that POEMS can also be associated with
an increase in cherry angiomas. Tr. 105-06; Resp. Ex. A at 4-5. Dr. Bourdette recalled that at
least one of petitioner’s treaters reported that she experienced a significant increase in cherry
angiomas as a part of her POEMS syndrome clinical course. Tr. 106. Based on his review of the
medical record, however, Dr. Bourdette could not say for certain if the increases reported were
35 Joanne Allam et al., Pulmonary Manifestations in Patients with POEMS Syndrome, 133 Chest
969 (2008).
36 On cross examination, Dr. Bourdette maintained that petitioner’s records did not include
persuasive evidence of complaints relating to lower facial numbness. Tr. 112-13; see Pet. Ex. 7
at 51. Dr. Bourdette explained that the numbness complaints in the record were reported by a
nurse (at some point after her ER evaluation). Tr. 114. Based on his review of earlier records,
he could not determine which treatment record confirmed this notation. Id.
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well documented. Id. He also agreed with the testimony offered by Dr. Latov, characterizing
cherry angiomas as common in the general population. Id. Regardless, Dr. Bourdette posited
that the evidence of persistent thrombocytosis and the initial neuropathy were enough to
establish an onset of POEMS in November 2013. Id.
Given petitioner’s strong reliance on her initial improvement with IVIG treatment to
establish that her neuropathy-related symptoms were indicative of GBS at onset, Dr. Bourdette
spent some time discussing petitioner’s treatment in the context of her overall course. Tr. 96.
Dr. Bourdette acknowledged that petitioner had robust improvement following IVIG therapy
during her first hospital admission.37 Tr. 96, 115. Thereafter, she relapsed and received
additional rounds of IVIG without the same robust improvement. Tr. 96. After a third treatment,
Dr. Bourdette posited that petitioner’s response was less improved, so overall, her symptoms
clearly worsened over that period of time. Tr. 96-97, 115-16.
In addition, Dr. Bourdette explained that the medical literature on POEMS syndrome
indicates that patients with POEMS can experience a transient improvement of symptoms
following IVIG treatment. Tr. 97; Resp. Ex. A at 7; see Resp. Ex. A, Tab 10; Resp. Ex. A, Tab
1. He acknowledged, however, that it is well-accepted that IVIG is not a good or effective
treatment for POEMS. Tr. 97, 116. Dr. Bourdette stated that he had not personally treated any
POEMS patients with IVIG. Tr. 117. Even so, Dr. Bourdette did not accept this finding to be
persuasive in establishing that R.S. had GBS at the onset of her illness especially when taken into
context with her worsening course and eventual diagnosis. Tr. 97.
Dr. Bourdette next discussed the significance of petitioner’s SPEP testing conducted over
the course of her illness and its significance in determining the onset of POEMS. Tr. 100-03,
107-08. Consistent with Dr. Lipe and petitioner’s experts, Dr. Bourdette recalled that R.S.’s
SPEP test in November 2013, which was conducted without immunofixation, was interpreted as
normal. Tr. 100, 121. The SPEP with immunofixation was not conducted until February 2014.
Had the immunofixation and VEGF tests been conducted closer-in-time to her manifestation of
neuropathy symptoms, Dr. Bourdette speculated that her contemporaneous treaters likely would
have made the diagnosis of POEMS sooner. Tr. 107-08. Dr. Bourdette otherwise deferred to Dr.
Lipe regarding the significance of the beta peak spikes seen in the her earlier SPEP tests and what
those could have indicated at that time. Id.
Moving forward, Dr. Bourdette commented briefly on petitioner’s medical theory of
causation. Tr. 108. Consistent with Dr. Lipe, Dr. Bourdette stated that he knew of no literature
linking vaccinations with POEMS syndrome or monoclonal gammopathies. Tr. 108-09; Resp.
Ex. A at 6-7. Dr. Bourdette also knew of no case reports or literature suggesting that GBS/CIDP
or the secondary immune stimulation produced as a result could cause POEMS with or without a
preceding vaccination. Tr. 109, 138. Given the lack of supportive scientific literature
associating GBS/CIDP with POEMS syndrome, Dr. Bourdette posited that petitioner’s theory
regarding vaccine causation was not well-supported. Tr. 109, 137-38. He otherwise did not
dispute petitioner’s assertion that the flu vaccine can cause GBS. Tr. 121, 124-25.
37 Dr. Bourdette also noted that petitioner received pain medication and physical therapy around
this time, which could have played some role in her overall improvement. Tr. 135-36.
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Dr. Bourdette deferred to Dr. Lipe on multiple topics related to plasma cell dyscrasias
and the origins of monoclonal gammopathies. Tr. 121-22. On cross examination, he offered
some further comments regarding the role of proinflammatory cytokines in the pathogenesis of
POEMS syndrome. Tr. 122. Dr. Bourdette agreed that the relevant literature filed in this matter
suggests that the proinflammatory cytokines have shown to be elevated in POEMS patients. Id.
He posited that the IL-6 variant, specifically, can stimulate VEGF. Id. Even so, Dr. Bourdette
maintained that cytokines have not been deemed a causal mechanism for POEMS. Tr. 123. In
his view, speculation regarding the role of cytokines in the development of POEMS stems from
the recognition that VEGF responds quite easily to therapy. Id.
VI. DISCUSSION
A. Legal Framework
The Vaccine Act was established to compensate vaccine-related injuries and deaths.
§ 10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system
as a simple, fair and expeditious means for compensating vaccine-related injured persons. The
Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty
and generosity.’” Rooks v. Sec’y of Health & Human Servs., 35 Fed. Cl. 1, 7 (1996) (quoting
H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). In particular, petitioner must prove that that the vaccine was “not only
[the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Id. at
1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir.
1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A
petitioner who satisfies this burden is entitled to compensation unless respondent can prove, by a
preponderance of the evidence, that the vaccinee’s injury is “due to factors unrelated to the
administration of the vaccine.” § 13(a)(1)(B).
i. Causation
To receive compensation under the Program, petitioner must prove either: (1) that she
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that he received, or (2) that she suffered an injury that was caused by a vaccination. See
§§ 13(a)(1)(A) and 11(c)(1); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317,
1319-20 (Fed. Cir. 2006). Petitioner must show that the vaccine was “not only a but-for cause of
the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321
(quoting Shyface, 165 F.3d at 1352-53).
Because petitioner does not allege that she suffered a Table injury, she must prove that
the vaccine caused her illness. To do so, she must establish, by preponderant evidence: (1) a
medical theory causally connecting the vaccine and his injury (“Althen Prong One”); (2) a
logical sequence of cause and effect showing that the vaccine was the reason for her injury
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(“Althen Prong Two”); and (3) a showing of a proximate temporal relationship between the
vaccine and his injury (“Althen Prong Three”). § 13(a)(1); Althen v. Sec’y of Health & Human
Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
The causation theory must relate to the injury alleged. Thus, petitioner must provide a
reputable medical or scientific explanation for her theory, although the explanation need only be
“legally probable, not medically or scientifically certain,” it must be “sound and reliable.”
Boatman v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019); Knudsen v.
Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner cannot
establish entitlement to compensation based solely on assertions. Rather, a vaccine claim must
be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In
determining whether petitioner is entitled to compensation, the special master shall consider all
material contained in the record, including “any . . . conclusion, [or] medical judgment . . . which
is contained in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must weigh
the submitted evidence and the testimony of the parties’ offered experts and rule in petitioner’s
favor when the evidence weighs in his favor. See Moberly, 592 F.3d at 1325-26 (“[f]inders of
fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence
presented to them and, if appropriate, as to the credibility of the persons presenting that
evidence”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in petitioner’s favor).
ii. Law Governing Analysis of Fact Evidence
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. § 11(c)(2). The special master is required to
consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner's illness, disability,
injury, condition, or death,” as well as “the results of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.” § 13(b)(1)(A). The special master is
then required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such a determination is evidenced
by a rational determination).
Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient's
health problems). Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir.
1993); Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the
inconsistencies between petitioner's testimony and his contemporaneous medical records, the
special master’s decision to rely on petitioner's medical records was rational and consistent with
applicable law”); Rickett v. Sec’y of Health & Human Servs., 468 F. App’x 952 (Fed. Cir. 2011)
(non-precedential opinion). This presumption is based on the linked propositions that (i) sick
people visit medical professionals; (ii) sick people honestly report their health problems to those
professionals; and (iii) medical professionals record what they are told or observe when
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examining their patients in as accurate a manner as possible, so that they are aware of enough
relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health & Human
Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v.
Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d 1525 (Fed. Cir.
1993).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony—
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991) (citing United
States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight”)), aff’d, 968 F.2d 1226 (Fed. Cir. 1992).
However, there are situations in which compelling oral testimony may be more
persuasive than written records, such as where records are deemed to be incomplete or
inaccurate. Campbell v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any
norm based upon common sense and experience, this rule should not be treated as an absolute
and must yield where the factual predicates for its application are weak or lacking”); Lowrie,
2005 WL 6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be
accorded less deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct.
at 733)). Ultimately, a determination regarding a witness’s credibility is needed when
determining the weight that such testimony should be afforded. Andreu v. Sec’y of Health &
Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
iii. Evaluation of Expert Testimony
Another important aspect of the causation-in-fact case law under the Vaccine Act
concerns the factors that a special master may consider in evaluating the reliability of expert
testimony and other scientific evidence. In Daubert v. Merrell Dow Pharm., Inc., the Supreme
Court listed certain factors that federal trial courts should utilize in evaluating proposed expert
testimony concerning scientific issues. 509 U.S. 579 (1993). In Terran v. Sec’y of Health &
Human Servs., the Federal Circuit ruled that it is appropriate for special masters to utilize the
Daubert factors as a framework for evaluating the reliability of causation-in-fact theories
presented in Program cases. 195 F.3d 1302, 1316 (Fed. Cir. 1999).
Daubert instructs fact-finders to consider “(1) whether a theory or technique can be (and
has been) tested; (2) whether the theory or technique has been subjected to peer review and
publication; (3) whether there is a known or potential rate of error and whether there are
standards for controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing
Daubert, 509 U.S. at 592-95). In addition, where both sides offer expert testimony, a special
master’s decision may be “based on the credibility of the experts and the relative persuasiveness
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of their competing theories.” Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339,
1347 (Fed. Cir. 2010) (citing Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1362
(Fed. Cir. 2000)). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder v. Sec’y of Health
& Human Servs., 88 Fed. Cl. 706, 743 (2009) (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136,
146 (1997)).
A treating physician’s opinions are considered “quite probative,” as treating physicians
are in the “best position” to evaluate the vaccinee’s condition. Capizzano, 440 F.3d at 1326.
However, no treating physician’s views bind the special master, per se; rather, their views should
be carefully considered and evaluated. § 13(b)(1); Snyder, 88 Fed. Cl. at 745 n.67. Each
opinion from a treating physician should be weighed against other, contrary evidence present in
the record – including conflicting opinions from other treating physicians. Hibbard v. Sec’y of
Health & Human Servs., 100 Fed. Cl. 742, 749 (Fed. Cl. 2011), aff’d, 698 F.3d 1355 (Fed. Cir.
2012); Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119, 136 (Fed. Cl. 2011), aff’d,
463 F. App’x 932 (Fed. Cir. 2012); Veryzer v. Sec’y of Health & Human Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), aff’d, 100 Fed. Cl. 344 (2011).
iv. Consideration of Medical Literature
Both parties filed medical and scientific literature in this case, including some articles
that do not weigh heavily on the outcome herein. The undersigned has reviewed and considered
all of the medical literature submitted in this case, though the undersigned only discusses those
articles that are most relevant to entitlement and/or are central to petitioner’s case – just as the
undersigned has not exhaustively discussed every individual medical record filed. Moriarty v.
Sec’y of Health & Human Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“[w]e generally
presume that a special master considered the relevant record evidence even though he does not
explicitly reference such evidence in his decision”) (citation omitted)); see also Paterek v. Sec’y
of Health & Human Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain
information not relevant does not lead to—and likely undermines—the conclusion that it was not
considered”).
B. Analysis
i. The Evidence Supports a POEMS Diagnosis with Onset in November 2013.
Although the parties agree that petitioner was appropriately diagnosed with POEMS
syndrome, they firmly dispute the onset of the condition, as well as the appropriate diagnosis for
her neuropathy-related symptoms in October and November 2013. Both sides devoted time at
hearing to addressing whether vaccine-induced GBS could be shown to cause POEMS
syndrome. The medical records in this case, however, suggest a more pertinent question:
whether petitioner had GBS at all. The medical theory of causation proffered by petitioner
hinges on the undersigned finding that her neuropathy-related symptoms in October and
November 2013 are attributable to a GBS diagnosis, not POEMS. Therefore, if petitioner did not
suffer from GBS at the outset, then her claim cannot succeed.
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As Federal Circuit precedent establishes, in certain cases it is appropriate to determine the
nature of a petitioner’s injury before engaging in the Althen analysis. Broekelschen, 618 F.3d at
1346. Since “each prong of the Althen test is decided relative to the injury[,]” determining facts
relating to the claimed injury can be significant in a case like this, where the petitioner has an
evolving course of symptoms, resulting in a changed diagnosis. Id. Thus, before determining if
petitioner has met each prong of Althen, the undersigned addresses whether she has established,
by a preponderance of the evidence, that she suffered from GBS as a precursor illness to her
later-diagnosed POEMS syndrome.
It is indisputable that petitioner’s treaters considered both GBS and CIDP diagnoses over
the course of her illness and followed the appropriate treatment protocol for both diseases. See,
e.g., Pet. Ex. 7 at 54-55; Pet. Ex. 5 at 63-66, 681. The experts in this matter agreed that GBS and
POEMS syndrome are distinct conditions, consistent with the descriptions outlined above. They
differed, however, on the interpretation of petitioner’s initial neuropathy-related symptoms in
October 2013 as attributable to GBS or POEMS. Although there is earlier-in-time evidence in
the medical records interpreting petitioner’s course as GBS, and CIDP thereafter, those records
by themselves, viewed in retrospect, suggest that petitioner more likely than not suffered from
POEMS syndrome at the outset, rather than GBS or CIDP.
The medical records establish that petitioner began experiencing neuropathy-related
symptoms in October and November 2013, initially thought to be indicative of GBS. See, e.g.,
Pet. Ex. 7 at 54-55; Pet. Ex. 5 at 681. Even after treatment in the months thereafter, however,
petitioner experienced multiple relapses in her symptoms causing her treaters to suspect she may
have CIDP. Her symptoms remained persistent through 2014, despite receiving treatment for
presumed GBS and later CIDP, a fact Dr. Lipe noted and relied upon in opining that petitioner
likely had POEMS syndrome from the early stages. Because GBS/CIDP and POEMS can be
confused in their initial presentations, it is not surprising that the treating physicians who first
saw petitioner in late 2013 reached different conclusions from those treating her later, in August
2014.
Laboratory testing, followed by an alteration of petitioner’s treatment, also strongly
supports the POEMS diagnosis. By August 2014, the fact that her symptoms, including
neuropathy-related sequelae and thrombocytosis had still not fully cleared, and now included
additional symptoms, such papilledema, prompted treaters to test petitioner for elevated serum
VEGF based on her persistent neuropathic symptoms and positive SPEP testing. The medical
literature strongly associates high-dose melphalan, cyclophosphamide, and stem cell
transplantation with the successful treatment of POEMS. See, e.g., Pet. Ex. 29, Tab F at 219-20.
Petitioner improved thereafter following similar treatment. Pet. Ex. 18 at 385-93; Pet. Ex. 19 at
27.
As noted earlier, petitioner objects to the POEMS diagnosis made in October/November
2013. Her experts seemingly posit that greater weight should be given to the views of her early-
in-time treating physicians who made the initial GBS/CIDP diagnoses, despite the fact that
petitioner’s later-in-time treatment evaluations took into account her persistent and evolving
symptoms. Indeed, petitioner’s early treaters reached immediate conclusions about the nature of
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petitioner’s neuropathy-related symptoms without the benefit of the evidence Drs. Yee, Fogerty,
and Dispenzieri later relied on, including the laboratory tests, altered treatment, and
persistent/new onset of symptoms. There is no evidence in the record suggesting that any other
treating physicians who saw petitioner after the POEMS diagnosis was established disagreed
with the conclusions regarding her ultimate diagnosis, or posited that any precursor illness, like
GBS, was appropriate.
The undersigned finds that Dr. Lipe’s interpretation of the above-referenced records
regarding disease onset and progression was ultimately more persuasive. Dr. Lipe based her
opinion on a complete review of the record in light of petitioner’s entire course. Having treated
multiple POEMS patients, she observed that a patient may experience neuropathy-related
symptoms long before they are actually diagnosed with POEMS and even before such a
diagnosis might be proper based on the diagnostic criteria. Tr. 268-67. Because of the chronic
nature of their symptoms, POEMS patients are routinely misdiagnosed with conditions similar to
GBS, including AIDP and CIDP. Tr. 260-61, 282, 293.
Given the above, Dr. Lipe distinguished petitioner’s initial neuropathy, including pain
and edema, and persistent thrombocytosis as best attributable to POEMS in light of later records
indicating the presence of monoclonal gammopathy, an increase in cherry angiomas, and
elevated serum VEGF. Tr. 265-66, 284, 293. She posited that early examinations and test
results did not display all of the formal criteria for the condition at onset which is typical based
on the literature discussing its progression over time. See, e.g., Pet. Ex. 29, Tab Q; Resp. Ex. A,
Tab 6.
Dr. Lipe was also more persuasive in identifying inconsistencies in petitioner’s history
that prolonged the initial POEMS syndrome diagnosis. Through her reading of petitioner’s
contemporaneous SPEP test results, she pointed out that early symptoms and testing actually
supported a suspicion for a POEMS diagnosis prior to the date documented in the record—the
beta spikes, for example, evident from petitioner’s November 2013 SPEP test (see Pet. Ex. 5 at
770-71) were abnormal in her view. Tr. 268, 271. Dr. Lipe felt these spikes were likely
concerning evidence of an underlying plasma cell disorder. Moreover, she explained that
petitioner’s initial treatment with IVIG therapy likely resulted in some positive improvement to
her neuropathy-related symptoms in the early stages given it is the preferred treatment for the
condition. Tr. 264, 295. All in all, however, petitioner’s response to IVIG became less robust
over time with no eventual resolution, as the medical record indicates. Dr. Lipe also pointed out
that petitioner received steroid treatment during her multiple hospital stays, which could have
resulted in additional improvement.
In response, petitioner’s experts failed to establish a reasonable explanation for
petitioner’s course in light of her complete medical history. They placed too much emphasis on
petitioner’s earlier-in-time records and treatment responses, indicating that petitioner likely had
GBS/CIDP. Indeed, petitioner’s later-in-time treaters had the benefit of reviewing the additional
evidence regarding petitioner’s condition, for example, SPEP with immunofixation confirming
the existence of monoclonal gammopathy and confirmed elevated serum VEGF levels. Drs.
Latov and Parekh generally found more significant the initial GBS/CIDP diagnoses and the IVIG
treatment she received thereafter without explaining the subsequent changes in her course and
overall improvement following treatment for POEMS syndrome.
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Furthermore, Drs. Latov and Parekh were selective in their interpretation of petitioner’s
multitude of symptoms without taking into consideration her POEMS course as a whole. For
instance, Dr. Latov posited that petitioner’s cherry angioma eruption and thrombocytosis were
nonspecific findings in the context of both GBS and POEMS given their overall presence in the
general population at large. Tr. 44-45. Dr. Parekh, by contrast, agreed that thrombocytosis
could be attributable to POEMS syndrome, but he maintained it was not enough to diagnosis the
condition. Tr. 245-46. In so stating, both experts interpreted the above-described symptoms in
isolation of petitioner’s entire course, without taking into consideration the progression of her
symptoms and relevant laboratory testing in retrospect.
Regarding petitioner’s cranial nerve symptoms, Drs. Latov and Parekh maintained that
instances of drooling are best attributable to a GBS diagnosis. Tr. 24, 55, 76, 231. POEMS, by
contrast, is typically not associated with cranial nerve involvement. See Resp. Ex. A, Tab 6 at
678 (case report of POEMS patient indicating “no cranial and autonomic nerve involvement”
upon exam). Upon further questioning, however, Dr. Latov acknowledged that there are
instances of POEMS-related cranial nerve dysfunction reported in the older literature. Tr. 59.
Dr. Lipe agreed that drooling is not a typical POEMS-related symptom, but she maintained that
pulmonary and swallowing difficulties are attributable to POEMS syndrome. Tr. 267; see Resp.
Ex. C, Tab 3 at 2500-01; Pet. Ex. 31, Tab C at 955. Along those same lines, Dr. Bourdette
maintained that R.S.’s drooling was likely a consequence of the respiratory and swallowing
problems she experienced, which would be attributable to the lower cranial nerve. Tr. 98-100;
see Resp. Ex. H at 971.
All in all, Dr. Lipe was more persuasive in discussing what was relevant in diagnosing
POEMS based on evidence from contemporaneous medical records before and after petitioner’s
actual date of diagnosis and the relevant medical literature. In so doing, she convincingly
offered an interpretation of the medical history that petitioner has not rebutted. It is thus
improbable that petitioner suffered from distinct GBS as a precursor illness to her later-
diagnosed POEMS syndrome.
ii. Althen Analysis
1. Althen Prong One: Petitioner’s Medical Theory
Under Althen Prong One, petitioner must set forth a medical theory explaining how his
flu vaccine could have caused the injury alleged. Andreu, 569 F.3d at 1375; Pafford, 451 F.3d at
1355-56. Petitioner’s theory of causation must be informed by a “sound and reliable medical or
scientific explanation.” Knudsen, 35 F.3d at 548; see also Veryzer v. Sec’y of Health & Human
Servs., 98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 13(b)(1) and
Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If
petitioner relies upon a medical opinion to support his theory, the basis for the opinion and the
reliability of that basis must be considered in the determination of how much weight to afford the
offered opinion. See Broekelschen, 618 F.3d at 1347 (“[t]he special master’s decision often
times is based on the credibility of the experts and the relative persuasiveness of their competing
theories”); Perreira v. Sec’y of Health & Human Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994)
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(stating that an “expert opinion is no better than the soundness of the reasons supporting it”)
(citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980)).
The undersigned’s conclusion that petitioner likely 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 requires a finding
that she experienced vaccine-induced GBS. The undersigned will, however, consider the
evidence offered by petitioner in support of the first Althen prong under the assumption that
petitioner offered preponderant evidence in support of a GBS diagnosis.
The molecular mimicry theory has been accepted in the Vaccine Program as a reliable
explanation for how the flu vaccine can initiate an autoimmune process resulting in GBS. See,
e.g., Reichert v. Sec’y of Health & Human Servs., No. 16-697V, 2018 WL 4496561, at *15 (Fed.
Cl. Spec. Mstr. Aug. 2, 2018). Indeed, both Drs. Latov and Parekh offered reputable scientific
literature associating the flu vaccine with an onset of GBS thereafter via the mechanistic process
of molecular mimicry. See, e.g., Pet. Ex. 29, Tab P at 105.
Apart from her inability to show that she more likely than not suffered from GBS at the
outset, however, petitioner has also failed to preponderantly establish that chronic inflammation
produced secondarily due to GBS can result in plasma cell proliferation let alone instigate
POEMS syndrome specifically. As discussed above, Drs. Latov and Parekh propose that the
chronic stimulation of B-cells can cause the body to produce an abundance of plasma cells. Tr.
33, 50-51, 232, 240-41. The medical articles offered in support, however, do not support this
assertion. Notably, none of the articles cited by petitioner’s experts associate chronic immune
stimulation pathologically with the onset of POEMS syndrome. See, e.g., Pet. Ex. 29, Tab E; Pet.
Ex. 31, Tab M; Pet. Ex. 31, Tab W; Pet. Ex. 61. Indeed, the mouse model evidence offered by
Dr. Parekh shows only that the mineral oil, pristane, a substance wholly distinguishable from a
vaccine, can stimulate plasma cell growth. See, e.g., Pet. Ex. 68; Pet. Ex. 60.
At best, petitioner offered the Lindqvist article to establish that patients with an
established autoimmune disease have an increased risk of developing a plasma cell disorder. See
Pet. Ex. 59 at 6284. As the undersigned discussed at length above, however, petitioner has not
preponderantly established that she suffered from an autoimmune condition, whether GBS or
CIDP, as a result of the flu vaccine. Moreover, the relevant literature offered by experts on both
sides which discusses the pathogenesis of POEMS syndrome makes no mention of immune
stimulation, whether chronic or acute, as an acceptable biologic mechanism capable of causing
the condition. Petitioner’s expert, Dr. Latov, even acknowledged at hearing that petitioner’s case
would be the first reported instance of POEMS syndrome occurring as a direct result of
GBS/CIDP via the mechanism posited herein. Tr. 54. Such a novel theory, without more
persuasive scientific evidence, does not rise to the level of sound and reliable. See Boatman, 941
F.3d at 1360.
Another questionable element of petitioner’s theory is her proposition that cytokine
upregulation, presumably attributable to the flu vaccine, could have played a pathogenic role in
the development of POEMS syndrome. Petitioner’s experts have referenced medical literature
showing that mice injected with various cytokine variants can express an over production of
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plasma cells. Moreover, there is some evidence in the record suggesting that elevated serum
VEGF levels are thought to be associated with POEMS syndrome pathogenesis. See, e.g., Pet.
Ex. 29, Tab F at 215. Drs. Latov and Parekh have further discussed literature showing that
VEGF has been shown to be elevated in the POEMS population at large. Even so, petitioner has
not persuasively shown how a vaccine or its components can stimulate VEGF or any other
cytokine, so as to cause POEMS syndrome.
In summary, petitioner has not offered a sound and reliable medical theory in support of
her claim. Petitioner has not met the preponderant evidentiary standard with respect to the first
Althen prong.
2. Althen Prong Two: Logical Sequence of Cause and Effect
Under Althen Prong Two, a petitioner must prove by a preponderance of the evidence
that there is a “logical sequence of cause and effect showing that the vaccination was the reason
for the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). “Petitioner
must show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the
vaccine was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (internal citations omitted).
As noted above, the medical record and testimony herein establishes that petitioner
suffers from POEMS syndrome, with the first symptom manifesting in October and November
2013. The undersigned’s findings with respect to the medical theory proffered in this case along
with the appropriate diagnosis for petitioner’s symptoms make it impossible for the undersigned
to conclude that petitioner successfully established a logical cause-and-effect sequence that in
this case the flu vaccine “did cause” petitioner’s POEMS syndrome or that the vaccine initiated
GBS, which caused POEMS. Without being able to establish a reliable medical theory, or that
she suffered from GBS, petitioner cannot show that the vaccine more likely than not caused her
illness thereafter.
Although some of petitioner’s treaters made some reference to her onset of symptoms
being temporally related to the flu vaccine, they did so based on the assumption that she had
experienced GBS or CIDP at the outset. Following her diagnosis with POEMS, no treaters
appear to have embraced an association between the flu vaccine and petitioner’s subsequent
development of POEMS. Indeed, even petitioner’s experts acknowledged that vaccines likely do
not play a causative role in the development of POEMS syndrome.
3. Althen Prong Three: Proximate Temporal Relationship
Under Althen Prong Three, petitioner must provide “preponderant proof that the onset of
symptoms occurred within a time[] frame for which, given the medical understanding of the
disorder’s etiology, it is medically acceptable to infer causation-in-fact.” De Bazan v. Sec’y of
Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The acceptable temporal
association will vary according to the medical theory advanced in the case. See Pafford, 451
F.3d at 1358. A temporal relationship between a vaccine and an injury, standing alone, does not
constitute preponderant evidence of vaccine causation. See, e.g., Veryzer, 100 Fed. Cl. at 356
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(explaining that “a temporal relationship alone will not demonstrate the requisite causal link and
that petitioner must posit a medical theory causally connecting [the] vaccine and injury”).
Roughly two weeks passed between petitioner’s receipt of the flu vaccine and the onset
of her symptoms initially thought to be caused by GBS. There is support in the relevant medical
literature for the conclusion that the timeframe between vaccination and petitioner’s subsequent
symptoms was medically acceptable—assuming she suffered from GBS as she alleges. See, e.g.,
Pet. Ex. 29, Tab P at 105.
However, as outlined above, petitioner has not established that she more likely than not
suffered from GBS at the outset of her illness. Moreover, even if petitioner had accepted the
conclusion that her symptoms in October and November 2013 were indicative of POEMS, and
argued that it was caused by her receipt of the flu vaccine, there would still be a lack of a
medically-acceptable temporal relationship, due to the fact that neither Dr. Latov nor Dr. Parekh
proposed that vaccinations could cause POEMS syndrome at all let alone offered some medically
cognizable timeframe for such an injury. Petitioner thus has not met her burden on the third
Althen prong.
VII. CONCLUSION
POEMS syndrome has caused significant distress in petitioner’s life, and the undersigned
empathizes with her dedicated search for medical and scientific answers. However, for all the
reasons discussed above, the undersigned finds that petitioner has not established by
preponderant evidence that she is entitled to compensation and her petition must be dismissed.
In the absence of a timely filed motion for review pursuant to Vaccine Rule 23, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance with this Decision.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master
42

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_15-vv-01207-2
Date issued/filed: 2020-07-17
Pages: 25
Docket text: **RE-DOCKETED 160 TO CORRECT FILING ERROR** JUDGE VACCINE UNREPORTED OPINION on 157 JUDGE VACCINE ORDER/OPINION Signed by Judge Ryan T. Holte. (sw) Service on parties made; petitioner served via U.S. mail. (dls)
--------------------------------------------------------------------------------
Case 1:15-vv-01207-RTH Document 162 Filed 07/17/20 Page 1 of 25
REISSUED FOR PUBLICATION
JUL 17 2020
OSM
U.S. COURT OF FEDERAL CLAIMS
In the United States Court of Federal Claims
No. 15-1207
Filed Under Seal: 19 June 2020
Reissued for Publication: 17 July 2020*
NOT FOR PUBLICATION
***************************************
R.S., *
*
Petitioner, * Vaccine Act; off-table case; influenza
* vaccine; Polyneuropathy, organomegaly,
v. * endocrinopathy, monoclonal gammopathy,
* and skin changes (“POEMS syndrome”);
SECRETARY OF HEALTH AND HUMAN * Guillain-Barré Syndrome (“GBS”).
SERVICES, *
*
Respondent. *
*
***************************************
R.S., petitioner, pro se.
Linda S. Renzi, Senior Trial Attorney, Torts Branch, Civil Division, U.S. Department of
Justice, with whom were Joseph H. Hunt, Assistant Attorney General, C. Salvatore D’Alessio,
Acting Director, Catherine E. Reeves, Deputy Director, all of Washington, DC, for respondent.
OPINION AND ORDER
Petitioner R.S. (“petitioner”) moved for review of Special Master Dorsey’s decision that
petitioner is not entitled to compensation under the National Vaccine Injury Compensation
Program (“Vaccine Act” or “the Program”), 42 U.S.C. § 300aa-10, et seq. Petitioner claims she
suffered Guillain-Barré Syndrome (“GBS”) and, subsequently, polyneuropathy, organomegaly,
endocrinopathy, monoclonal gammopathy, and skin changes (“POEMS” or “POEMS
syndrome”), as a result of the influenza (“flu”) vaccine she received on 1 October 2013. The
Special Master denied compensation and found petitioner “failed to provide preponderant
evidence that the flu vaccine . . . caused her injuries.” R.S. v. Sec’y of Health & Human Servs.,
No. 15-1207V, 2019 WL 7631017, at *1. (Fed. Cl. Spec. Mstr. Dec. 19, 2019).
I. Background
*This opinion was initially filed under seal pursuant to Vaccine Rule 18(b) of the Rules of the Court of Federal
Claims. The Court provided the parties 14 days to propose redactions, if any, before the opinion was released for
publication. Neither party proposed redactions. This opinion is now reissued for publication in its original form.
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Case 1:15-vv-01207-RTH Document 162 Filed 07/17/20 Page 2 of 25
A brief recitation of the facts provides necessary context.1
A. Petitioner’s Medical History and the Vaccination
Petitioner was born on 23 August 1972. Id. at *3. Before receiving the flu vaccination,
petitioner did not have a history of neurological abnormalities, but had a history of cherry
angiomas, basal cell neoplasms, and depression. Id.
Petitioner received the flu vaccine at issue on 1 October 2013. Id. “No adverse reaction
was noted at the time of vaccine administration.” Id. On 6 November 2013, petitioner was seen
by Dr. Gopalan Umashanker, a neurologist at Cottage Hospital, when she “complained of
weakness and numbness in her legs.” Id. at *3. She reported to Dr. Umashanker that three days
after her flu vaccination, “she experienced severe diarrhea and stomach pain.” R.S., 2019 WL
7631017, at *3. She also reported that around 10 October 2012, “she developed numbness in the
tips of her toes, which eventually ascended to the pads of her feet and toes.” Id. By the time she
saw Dr. Umashanker, her symptoms progressed to include “pain in the calves and hips, fatigue,
palpitations, numbness in the fingers, unsteady gait, and drooling.” Id. “Dr. Umashanker
assessed [petitioner] with ‘probabl[e]’ GBS 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. (quoting Pet’r’s Ex. 6, at 2). Petitioner “was admitted to Dartmouth
Hitchcock Medical Center (“Dartmouth”) that same day for further testing.” Id.
At Dartmouth, petitioner “was seen by a second neurologist, Dr. Elijah Stommel,” who
“reviewed [petitioner’s] history and opined that her course was ‘concerning for acute
inflammatory demyelinating polyneuropathy’ or AIDP.” Id. (quoting Pet’r’s Ex. 7, at 6). A
lumbar puncture “showed a slightly elevated protein of 57 (range: 15-45) with normal glucose.”
R.S., 2019 WL 7631017, at *3. An electromyography (“EMG”) “was consistent with a
generalized peripheral neuropathy with demyelinating features.” Id. Petitioner’s “lab tests also
indicated she had thrombocytosis, with an elevated platelet count of 473 x10(3)/mcL.”2 Id.
Petitioner’s discharge notes indicated a five-day course of intravenous immunoglobulin (“IVIG”)
treatment improved her extremity strength. Id. On 11 November 2013, she was discharged
“with diagnoses of GBS and AIDP.” Id.
From 26 to 29 November 2013, petitioner was hospitalized at Littleton Regional
Healthcare (“Littleton Regional”) “due to difficulties with her speech and gait.” Id. at *4. She
reported she experienced “increased tingling in the legs and fingers, difficulty walking, chest
pain, and voice issues, roughly thirty-six hours prior to presentation.” R.S., 2019 WL 7631017,
at *4. Petitioner’s treating physicians “assessed her with a GBS flare and recommended further
treatment with IVIG.” Id. On 27 November 2013, “Dr. Stephen Goldberg conducted a serum
protein electrophoresis (“SPEP”) test without immunofixation (“IFE”) to test for monoclonal
gammopathy,” a mandatory criterion for POEMS syndrome. Id. Petitioner “tested negative for
the monoclonal protein,” and “[t]he assessment remained GBS with treatment related
1 As the basic facts in this case have not changed significantly since the Special Master’s decision in this case, the
Court’s recitation of the background facts herein draws from that decision.
2 Thrombocytosis is “[a]n increase in the number of platelets in the circulating blood.” Thrombocytosis, Stedmans
Medical Dictionary (Westlaw, last updated Nov. 2014).
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Case 1:15-vv-01207-RTH Document 162 Filed 07/17/20 Page 3 of 25
fluctuation.” Id. Discharge records indicated IVIG treatment improved petitioner’s paresthesia3
and gait. Id.
On 10 December 2013, petitioner was readmitted to Littleton Regional for persistent
lower extremity weakness, sensory loss, paralysis in the lower extremities, paresthesia, gait
abnormalities, and leg pain. Id. She received two infusions of IVIG treatment “with no
improvement in strength.” R.S., 2019 WL 7631017, at *4. At this time, she was transferred back
to Dartmouth to finish the five-day course of IVIG, which resulted in “a steady improvement in
strength noted following her last treatment.” Id.
On 20 December 2013, petitioner “presented for a follow-up appointment with Dr.
Stommel” at Dartmouth. Id. “Dr. Stommel noted residual complaints, including sensory loss in
the lower extremities, weakness in both legs, and subtle weakness in the biceps.” Id. “A repeat
nerve conduction study 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” and “prescribed Cellcept.”4 Id. Lab testing administered on 26 December 2013 and
15 January 2014 showed that petitioner’s “thrombocytosis remained persistent with elevated
platelet levels.” R.S., 2019 WL 7631017, at *4.
On 27 January 2014, petitioner was admitted to Littleton Regional for a fourth
hospitalization. Id. She “complained of cognitive issues, fever, and chills” and indicated she
“had ‘trouble remembering things.’” Id. (quoting Pet’r’s Ex. 5, at 64). She was diagnosed with
“aseptic meningitis secondary to an IVIG treatment she received” on 23 January 2014. Id. “An
MRI of the thoracic spine showed a spinal cord neoplasm at the T12-L1 level.” Id. The
neurologist “opined that the neoplasm was likely incidental and not related to petitioner’s
paresthesia, which he deemed to be related to a CIDP diagnosis.” Id.
On 4 February 2014, “petitioner presented to the Massachusetts General Hospital
(“MGH”) neuromuscular clinic for an evaluation of her persistent symptoms.” R.S., 2019 WL
7631017, at *4. “Dr. Michael Bowley conducted a repeat EMG and nerve conduction analysis,
both of which continued to show evidence of sensory and motor polyneuropathy.” Id. “Dr.
Bowley concluded that [petitioner] likely had CIDP, with multiple subsequent relapses.” Id. Dr.
Bowley considered petitioner’s “‘initial improvement’ with IVIG . . . supportive of such a
diagnosis; however, . . . her repeated relapses did not respond as well to further IVIG treatment.”
3 Paresthesia is “[a] spontaneous abnormal usually nonpainful sensation (e.g., burning, pricking); may be due to
lesions of both the central and peripheral nervous systems.” Paresthesia, Stedmans Medical Dictionary (Westlaw,
last updated Nov. 2014).
4 “Cellcept is the ‘trademark for preparations of mycophenolate mofetil.’” Miles v. Sec’y of Health & Human
Servs., 142 Fed. Cl. 136, 141 n.19 (2018) (quoting Dorland’s Illustrated Medical Dictionary 325 (32d ed. 2012)).
Cellcept is an immunosuppressant “used with other medications to help prevent transplant organ rejection (attack of
the transplanted organ by the immune system of the person receiving the organ) in people who have received
kidney, heart, and liver transplants. . . . It works by weakening the body’s immune system so it will not attack and
reject the transplanted organ.” Lehner v. Sec’y of Health & Human Servs., No. 08-554V, 2015 WL 5443461, at *21
& n.53 (Fed. Cl. Spec. Mstr. July 22, 2015) (internal quotation marks omitted) (quoting U.S. National Library of
Medicine, MedlinePlus, http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601081.html (last visited July 9,
2015)).
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Id. Petitioner’s “platelet count remained elevated.” Id. A 4 February 2014 SPEP test “was
negative for monoclonal protein.” Id.
On 12 February 2014, petitioner “was hospitalized for a thoracic laminectomy and mass
resection . . . , both of which were unrelated to her underlying disease course.” R.S., 2019 WL
7631017, at *5. Before her surgery, petitioner’s treating physicians discovered a spinal mass that
pathologic testing confirmed was a T12 hemangioma. Id. at *5. On 18 February 2014, petitioner
“was transferred to a rehabilitation facility for occupational and physical therapy.” Id. She was
discharged on 14 March 2014 with diagnoses including an “extradural spinal mass and post-T12
laminectomy, with a secondary diagnosis of GBS/CIDP.” Id. Petitioner was seen by Dr.
Jennifer Dineen for a follow-up appointment on 27 May 2014. Id. Petitioner “reported that she
continued to experience fatigue, weakness in her legs, tremors, nerve pain, gait abnormalities,
and blurry vision.” Id. After her exam indicated “sensory and motor neuropathy with features
indicative of a demyelinating polyneuropathy,” Dr. Dineen recommended petitioner continue to
take prescribed medication, but she “did not think further IVIG treatment would be helpful” to
petitioner at that time. R.S., 2019 WL 7631017, at *5.
Petitioner was seen at Littleton Regional on 14 July 2014 “with complaints of postural
headaches, diplopia, incontinence, and cognitive issues.” 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. A brain MRI also returned normal results. Id. Petitioner was also seen by an
ophthalmologist, Dr. Krista Haight, “for complaints associated with eye pressure, pain and hazy
vision.” Id. “Dr. Haight assessed petitioner with papilledema.”5 Id.
On 31 July 2014, petitioner was admitted to MGH for “complaints related to persistent
headaches and vision changes.” R.S., 2019 WL 7631017, at *5. Dr. Mingming Ning, a
neurologist, “suspected that [petitioner] might have POEMS syndrome and he recommended a
hematology consult.” Id. A 1 August 2014 SPEP test with immunofixation showed a “persistent
IgA lambda monoclonal protein with components at 0.15 and 0.06 g/dl.” Id.
When she returned to MGH on 12 August 2014, petitioner “complained of lethargy,
reduced appetite, and blurry vision.” Id. Dr. Annemarie Fogerty, the attending hematologist,
“assessed petitioner with a progressive neuropathy, dual M-spike, and thrombocytosis,
concerning for POEMS syndrome.” Id. Dr. Fogerty noted “petitioner satisfied the two major
criteria” for POEMS syndrome, neuropathy6 and monoclonal gammopathy,7 “as well as two
minor criteria: papilledema and thrombocytosis.” Id. On 14 August 2014, petitioner’s vascular
endothelial growth factor (“VEGF”) levels were elevated at 1799 (reference range: 31-86),
which confirmed her POEMS syndrome diagnosis. R.S., 2019 WL 7631017, at *5. Petitioner
5 Papilledema is “[e]dema of the optic disc, often due to increased intracranial pressure.” Papilledema, Stedmans
Medical Dictionary (Westlaw, last updated Nov. 2014).
6 Neuropathy is “a disease involving the cranial nerves or the peripheral or autonomic nervous system.”
Neuropathy, Stedmans Medical Dictionary (Westlaw, last updated Nov. 2014).
7 Monoclonal gammopathy is “any one of a group of disorders due to proliferation of a single clone of lymphoid or
plasma cells and characterized by the presence of monoclonal immunoglobulin in serum or urine (visible on
electrophoresis as a single peak).” Monoclonal gammopathy, Stedmans Medical Dictionary (Westlaw, last updated
Nov. 2014).
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was evaluated by another hematologist, Dr. Andrew Yee. Id. at *6. “Dr. Yee discussed POEMS
syndrome with [petitioner] and explained her course in light of the accepted diagnostic criteria.”
Id. He opined “multiple clinical factors identified in [petitioner’s] prior history, including:
polyneuropathy, IgA lambda gammopathy, markedly elevated VEGF levels, thrombocytosis, and
papilledema, supported a POEMS diagnosis.” Id. Petitioner was discharged on 18 August 2014.
Id.
On 29 January 2015, petitioner “underwent an autologous stem cell transplant,” which
improved her VEGF and platelet levels. Id.
On 17 June 2015, petitioner was seen by “Dr. Angela Dispenzieri, a hematologist at the
Mayo Clinic, for a second opinion regarding [petitioner’s] POEMS diagnosis.” R.S., 2019 WL
7631017, at *6. “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. Dr. Dispenzieri noted that by October to November 2013,
petitioner’s symptoms progressed to include “muscle pain, difficulty walking, ascending hip
pain, numbness in the fingers, and slight drooling,” which initially improved with IVIG
treatment. Id. Dr. Dispenzieri acknowledged additional treatment with IVIG through 2014 “did
not result in similar levels of improvement,” but “further treatment with cyclophosphamide
mobilization, high-dose melphalan, and stem cell infusion resulted in good improvement.” Id.
Dr. Dispenzieri concluded this course was consistent with POEMS syndrome. Id.
“As of May 2015, [petitioner] continues to be treated for POEMS.” Id. “She routinely
experiences fatigue, intermittent headaches, hot flashes, foot swelling and discomfort, and
diminished strength in both feet.” R.S., 2019 WL 7631017, at *6. Her gait has improved, and a
29 May 2015 neurological exam “showed normal function apart from marked weakness and
sensory loss in the lower limbs.” Id.
B. The Petition and Hearing Before the Special Master
Petitioner filed her vaccine petition against the Secretary of Health and Human Services
(“respondent”) on 15 October 2015. See Pet. for Vaccine Compensation, ECF No. 1. Petitioner
requested compensation for GBS and POEMS syndrome she allegedly developed after receiving
a flu vaccination on 1 October 2013. See id. at 1.
On 5 August 2016, petitioner filed the expert report of Dr. Norman Latov. See Pet’r’s
Ex. 29, ECF No. 26-1. Petitioner filed a supplemental medical expert report, also authored by
Dr. Latov, on 27 March 2017. See Pet’r’s Ex. 31. ECF No. 35-1. On 4 December 2017,
petitioner filed a second supplemental expert report authored by Dr. Latov. See Pet’r’s Ex. 38,
ECF No. 54-1. On 11 October 2018, petitioner filed the expert report of Dr. Samir Parekh. See
Pet’r’s Ex. 57, ECF No. 75-1.
On 6 January 2017, respondent filed the expert report of Dr. Dennis Bourdette. See
Resp’t’s Ex. A, ECF No. 33-1. On 16 June 2017, respondent filed the expert report of Dr. Brea
Lipe. See Resp’t’s Ex. C, ECF No. 40-1. Respondent filed a supplemental expert report, also
authored by Dr. Lipe, on 9 January 2019. See Resp’t’s Ex. E, ECF No. 101-1.
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The Special Master held a two-day hearing on 29 and 30 January 2019 in Boston,
Massachusetts. See Hr’g Tr., ECF Nos. 113–14. Petitioner and her husband testified, as well as
petitioner’s experts, Drs. Latov and Parekh. See Order at 1, ECF No. 104. Drs. Lipe and
Bourdette testified on behalf of respondent. See id.
1. Witness Testimony
a. Fact Witnesses
i. Russell S., M.D.
Petitioner’s husband, Dr. Russell S., began his testimony describing petitioner as
“healthy” and “very physically active” before her vaccination. Hr’g Tr. at 141:21–22, ECF No.
113. Dr. S. recalled when petitioner returned from a work conference after receiving the flu
vaccine, she began complaining that her feet were numb and felt pain in her calves. Id. at 145:8–
22. Dr. S. noted that after petitioner initially sought treatment in November 2013, her symptoms
began “rapidly progressing from a foot and ankle thing to essentially being paralyzed from the
waist down and starting to complain of the lower part of her hands being numb and tingly,” as
well as drooling, heart palpitations, and difficulty breathing. Id. at 147:15–20. Dr. S. next
recalled that petitioner’s symptoms improved “immediately upon receiving the IVIG” treatment.
Id. at 150:11–12. Dr. S. noted that upon discharge from Dartmouth, petitioner “still needed
assistance standing” and “still had problems with balance,” yet she returned home. Id. at
151:11–19. Dr. S. next recalled that about two weeks later petitioner was again hospitalized after
a relapse in her symptoms but improved after additional rounds of IVIG treatment. Id. at
152:22–25, 153:3–4.
Dr. S. testified that after petitioner’s third hospitalization, “there was hardly any change”
with additional IVIG treatment, in contrast with the “noticeable change” petitioner experienced
with the previous two infusions. Hr’g Tr. at 154:22–155:7. Dr. S. stated, “[a]t that point, we
were told that it’s not AIDP or [GBS] anymore, because she’s had it for too long, so now the
diagnosis was CIDP.” Id. at 160:4–6.
Next, Dr. S. stated around April-May 2014, petitioner began complaining of angiomas,
vision changes, head pain, and fatigue. Id. at 163:18–165:12. Dr. S. recalled that after an
August 2014 hematologist consult, petitioner’s POEMS syndrome diagnosis was confirmed
through blood testing. Id. at 166:18–21. Dr. S. testified that petitioner continues to suffer from
“a lot of ongoing physical disabilities,” including fatigue, pain, and mental health issues. Id. at
172:6–19.
ii. R.S.
Petitioner similarly began her testimony by describing herself as healthy and physically
active before receiving the vaccination. Id. at 184:18–19. Petitioner recalled about two weeks
after the vaccination she began experiencing numbness and swelling in her feet and fatigue.
Hr’g Tr. at 186:25–188:6. Petitioner testified that by early November 2013, her symptoms
advanced to include gait abnormalities, pain, numbness in the fingers and legs, and drooling. Id.
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at 188:7–189:20. After petitioner’s first hospitalization, she had enough upper body strength to
ambulate with a walker and spent the next couple of weeks at home until her second
hospitalization. Id. at 192:1–14. Petitioner testified that she “was discharged remarkably better”
after another round of IVIG treatment. Id. at 192:20–193:1. In the summer of 2014, petitioner
began to experience cranial pressure and papilledema. Id. at 195:18–19, 196:8–11. Petitioner
confirmed she was diagnosed with POEMS syndrome after VEGF levels were tested. Id. at
198:18–20.
Petitioner also recalled her visit with Dr. Dispenzieri, a POEMS syndrome expert, at the
Mayo Clinic. Hr’g Tr. at 199:13–18. Petitioner did not remember having a comprehensive or
detailed conversation of her medical history, but they had a good meeting and discussed a path
forward. Id. at 199:21–25. Petitioner further explained her confusion when she reviewed Dr.
Dispenzieri’s visit notes, which she claims contained factual inaccuracies. Id. at 200:11–19.
Lastly, petitioner testified that she continues to suffer POEMS-related symptoms, including
depression and anxiety. Id. at 202:8–204:8.
b. Expert Witnesses
i. Petitioner’s Expert Witness - Dr. Norman Latov, M.D.
Dr. Latov began his testimony by opining that petitioner was properly diagnosed with
GBS at the outset of her injury. Id. at 12:17–13:22. Dr. Latov described GBS as “an acute or
rapidly progressive neuropathy” and “[u]sually classically causing ascending weakness and
sensory loss.” Id. at 13:5–7. He also noted that GBS is “distinguished from other types of
neuropathies by . . . EMG neuroconduction studies and . . . neural absence of spinal fluid,
inflammatory changes and high CSF protein and responsive to treatment such as IVIG or
plasmapheresis.” Hr’g Tr. at 13:10–16.
Reviewing petitioner’s medical history, Dr. Latov first noted that petitioner developed
“symptoms of neuropathy,” such as “parasthesias in her hands” and “progressive weakness” two
weeks after her flu vaccine. Id. at 11:24–12:2. She also exhibited calf pain, ascending hip pain,
numbness in the fingers, gait problems, and drooling, all of which Dr. Latov testified was
consistent with a GBS diagnosis. Id. at 14:10–23. Based on his review of petitioner’s medical
records, Dr. Latov contended “she had a classical course” of GBS because “[s]he had the typical
CSF spinal fluid findings and typical EMG neuroconduction studies and response to IVIGs, so
she was a typical patient.” Id. at 13:19–22. He also acknowledged that petitioner “had a rapid
improvement in her strength” with IVIG treatment, which he claimed supports a GBS diagnosis
in the early stages of petitioner’s illness. Id. at 15:2–13.
Dr. Latov characterized petitioner’s several relapses as “GBS with treatment-related
fluctuations” and explained “the active period of disease could be six weeks or so, and the IVIG
treatment may only work for a couple of weeks, so within the active period of illness, the patient
may require repeat treatments if the initial treatments wore off.” Id. at 20:13–17. Dr. Latov
maintained petitioner’s course fit this pattern because “each treatment seem[ed] to result in
improvement for about two weeks, and then she would relapse.” Hr’g Tr. at 20:20–22. Dr.
Latov explained after petitioner’s repeated relapses, her diagnosis “changed to chronic
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inflammatory demyelinating neuropathy [(“CIDP”)], which is . . . chronic [GBS].” Id. at 22:5–
10.
Dr. Latov then noted after being diagnosed with CIDP in December 2013, petitioner
“presented with increasing intercranial pressure, and papilledema and was found to have high
VEGF levels,” which confirmed her POEMS syndrome diagnosis. Id. at 22:19–24. Dr. Latov
described POEMS syndrome as “a slowly progressive neuropathy [that is] associated with a
lambda monoclonal gammopathy, . . . high VEGF levels [and] does not respond well to IVIG or
plasmapheresis.” Id. at 23:12–15. He stated the diagnostic criteria for POEMS syndrome is “a
combination of neuropathy, monoclonal gammopathy, or Castleman’s disease and IVGF.” Id. at
24:1–2.
Dr. Latov opined that GBS and POEMS syndrome are distinct diagnoses, positing that
petitioner “had GBS which then evolved to CIDP, which is chronic GBS, and then she developed
evidence of POEMS syndrome after that.” Id. at 23:3–6. He also opined, “she probably had
POEMS syndrome and CIDP concurrently until she developed more obvious manifestations of
POEMS syndrome.” Hr’g Tr. at 23:6–8. He noted, “many [POEMS] patients are diagnosed with
CIDP first, and then later on, when they don’t respond to IVIG or steroids, they re-evaluate
diagnosis and they find that they have POEMS syndrome.” Id. at 24:7–10. Despite the
possibility for initial misdiagnosis, Dr. Latov maintained, “there was really no evidence for
POEMS and the course was highly atypical for POEMS syndrome. . . . Although she
subsequently did develop POEMS, at some point, . . . it certainly wasn’t within . . . the initial . . .
period of response to IVIG.” Id. at 54:24–55:7. He also distinguished the polyneuropathy
associated with POEMS syndrome from GBS-associated polyneuropathy by explaining the
former is “chronic, not responsive to IVIG, [and] not associated with cranial nerve involvement.”
Id. at 24:13–14.
Dr. Latov next described a medical theory of “the mechanism by which a flu vaccination
could cause autoimmunity[.]” Id. at 26:16–16. He explained, “something called molecular
mimicry in the vaccine[] may recognize [or] structurally may have a similarity to the target organ
and the immune system – the vaccinating agent turns against the body by mistake, because it’s
fooled into attacking itself.” Id. at 26:17–22. He agreed that molecular mimicry is an accepted
theory by which the flu vaccine causes GBS. See Hr’g Tr. at 27:8–22. He acknowledged,
though, that there is no association between vaccination and POEMS. Id. at 55:13–57:2.
Dr. Latov recognized there is “no proof” that GBS/CIDP “contribute[] to the
development of . . . POEMS syndrome.” Id. at 30:4–7. He nonetheless maintained it is “more
than a coincidence that [petitioner] developed monoclonal gammopathy and POEMS syndrome
in the course of her illness as a consequence of the chronic immune stimulation.” Id. at 30:7–10.
Dr. Latov acknowledged there are no studies making a direct connection between GBS/CIDP
and POEMS syndrome, and he instead relied upon individual case reports to causally connect
GBS, CIDP, and POEMS syndrome. Id. at 40:3–10.
ii. Petitioner’s Expert Witness - Dr. Samir Parekh, M.D.
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Dr. Parekh, like Dr. Latov, opined that petitioner initially presented with GBS in
November 2013 after receiving the flu vaccination, which subsequently caused petitioner to
develop POEMS syndrome in August 2014. Id. at 225:16–21.
Dr. Parekh explained the “[t]wo main [diagnostic] criteria [of POEMS] are a monoclonal
plasma cell disorder and neuropathy.” Hr’g Tr. at 226:7–8. The other criteria are “a high
vascular endothelial growth factor or Castleman’s disease or sclerotic lesions,” and the fourth
criterion “can be one of many minor criteria such as organomegaly, endocrinopathy, skin
changes, papilledema, thrombocytosis, and others.” Id. at 226:8–10, 226:23–227:1. Addressing
the diagnostic criteria, Dr. Parekh stated petitioner first developed polyneuropathy in 2013, then
a monoclonal plasma cell disorder in 2014, and “she ultimately presented with raised intracranial
tension and papilledema leading to the testing for [VEGF], which was elevated. And this all put
together made the diagnosis of POEMS syndrome.” Id. at 227:2–8. Dr. Parekh opined petitioner
did not meet the diagnostic criteria for POEMS syndrome until August 2014. Id. at 250:7–10.
He determined this date was the onset because “everything else can be hypothetical” and “[w]e
need data to be able to diagnose something and treat it.” Id. at 250:8–21.
Distinguishing petitioner’s early symptoms from her later course, Dr. Parekh noted
“petitioner’s initial presentation was characterized by an ascending neurological deficit,” which
he considered “more characteristic of GBS than of POEMS syndrome.” Id. at 246:25–247:5.
While he knew of “anecdotal examples where POEMS may respond” to IVIG treatment, his
preferred POEMS treatment is “directed at eradicating the plasma cell clone.” Hr’g Tr. at 231:3–
6. Further, Dr. Parekh testified that cranial nerve involvement, such as drooling, is atypical of
POEMS syndrome, but otherwise deferred to “someone with Dr. Latov’s experience” for
assessment of neurological symptoms. Id. at 231:8–14. Dr. Parekh also acknowledged
petitioner presented with thrombocytosis, in addition to neuropathies, in November 2013, but
asserted the symptom “is a nonspecific finding” because it “has very many other causes” and
“cannot be . . . specific enough for [POEMS] diagnosis.” Id. at 244:18–246:18.
Dr. Parekh, like Dr. Latov, opined that “chronic immune stimulation leads to plasma cell
dyscrasia,” which he posits caused petitioner to develop POEMS syndrome, a form of plasma
cell dyscrasia. Id. at 240:4–7; see also id. at 232:17–239:20. Dr. Parekh referenced two studies
that he claimed support the association of monoclonal gammopathy and plasma cell disorders.
See id. at 233:21–239:20. Dr. Parekh conceded, though, he was unaware of any medical
literature or other evidence, apart from the Lindqvist article, directly connecting GBS as a
precursor illness to POEMS syndrome. Id. at 251:19–252:6.
iii. Respondent’s Expert Witness - Dr. Brea Lipe, M.D.
Dr. Lipe opined that petitioner “had POEMS from the outset of her symptoms,”
beginning in October-November 2013. Hr’g Tr. at 260:17–18. Addressing the onset of POEMS
syndrome, Dr. Lipe referenced a study that found “85 percent of [POEMS] patients were initially
misdiagnosed, and . . . the most common diagnosis initially [was] CIDP and AIDP.” Id. at
261:6–9. Dr. Lipe explained “[t]he average amount of time it takes from the time a patient with
POEMS presents with symptoms to the diagnosis is 9 to 16 months[,] [s]o it’s typical that
patients aren’t diagnosed initially.” Id. at 262:21–24. Dr. Lipe did not consider
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petitioner’s “presentation . . . atypical compared to the other patients with POEMS that [she has]
ever had.” Id. at 267:24–268:1. Indeed, Dr. Lipe testified she has “treated patients who [she]
believes were initially misdiagnosed as having CIDP . . . . [a]nd then once [she] met them and
ultimately diagnosed them with POEMS and treated their underlying plasma cell dyscrasia, they
had improvement.” Id. at 262:6–10. She was “not aware of any coexisting literature or evidence
to suggest that you can have a distinct GBS and a distinct POEMS that are not related.” Id. at
262:11–13.
Discussing the relevance of petitioner’s thrombocytosis, Dr. Lipe agreed that
thrombocytosis “generally is very nonspecific,” but she nonetheless attributed petitioner’s
thrombocytosis in November 2013 and its persistence to POEMS syndrome. Hr’g Tr. at 266:2–
8. Dr. Lipe explained, “transient or reactive-type thrombocytosis . . . would get better over
time,” but petitioner’s “thrombocytosis never improved until she was started on definitive
therapy against her plasma cell dyscrasia, at which time her thrombocytosis improved.” Id. at
266:9–16.
Regarding petitioner’s initial positive response to IVIG treatment, Dr. Lipe agreed “the
majority of the literature suggests that patients with POEMS syndrome do not respond to IVIG.”
Id. at 264:13–15. She noted, however, “[t]here are case reports where patients do respond to
IVIg, and in general we can use IVIg to treat neuropathies associated with plasma cell
disorders.” Id. at 264:15–18. In that vein, Dr. Lipe opined, “it’s not irrelevant that [petitioner’s]
first admission was where she saw the bulk of her physical improvement and she got treated with
steroids.” Id. at 264:19–265:3. In support, Dr. Lipe referenced the Dispenzieri article, which
reported that fifty percent of patients with POEMS syndrome respond to steroid therapy. Id. at
265:4–8; see also Resp’t’s Ex. C, at 2501.
Next, Dr. Lipe disagreed with petitioner’s theory that chronic immune stimulation is “an
accepted pathogenic mechanism for the development of plasma cell dyscrasias.” Hr’g Tr. at
271:17–19. She testified she was unaware of any studies or case reports supporting petitioner’s
theory of causation. Id. at 272:12–19. Commenting on the article petitioner offered to support
the theory, Dr. Lipe noted the report found only six out of 26,000 patients studied had
monoclonal gammopathy of unknown significance with GBS. Id. at 275:22–276:3. Dr. Lipe
therefore asserted, “to make a strong conclusion based on that is not something that I think
anyone would suggest is evidence of pathogenesis.” Id. at 276:4–6. To the contrary, Dr. Lipe
testified, “we don’t really know what causes POEMS.” Id. at 290:4–5. Dr. Lipe explained that
she knows “proinflammatory cytokines have a role in POEMS syndrome, but what they do in
inflammatory diseases I can’t say.” Id. at 304:9–12.
iv. Respondent’s Expert Witness – Dr. Dennis Bourdette, M.D.
Dr. Bourdette, like Dr. Lipe, opined that petitioner suffered from POEMS syndrome from
the outset of her injury. Hr’g Tr. at 94:19–95:4. He also opined, “the flu vaccine did not play a
role in her development of POEMS.” Id. at 93:13–14.
Dr. Bourdette suggested, “the case needs to be put in the context of her ultimate diagnosis
of POEMS.” Id. at 94:19–21. Thus, “[l]ooking at [petitioner’s medical history] through the lens
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of that diagnosis,” Dr. Bourdette was “convinced that the subacute inflammatory neuropathy that
she experienced, which was diagnosed as idiopathic acute [GBS], was actually the first
manifestation of her POEMS.” Id. at 94:21–25. Additionally, Dr. Bourdette opined petitioner’s
“neuropathy in November of 2013 was actually caused by POEMS, which was not assessed for
at the time because it’s a rare presentation of a rare disease.” Id. at 95:1–4. Dr. Bourdette
observed, “there are case reports of patients who . . . either had established POEMS, or within a
few weeks or months of a neuropathy clearly had POEMS that presented with subacute [GBS]-
like neuropathy.” Id. at 95:8–11. Dr. Bourdette disagreed with Dr. Latov’s interpretation of
those case reports, asserting that “there is a subacute presentation of a demyelinating neuropathy
that is associated with POEMS,” rather than GBS. Hr’g Tr. at 95:20–22. Dr. Bourdette also
disagreed that petitioner “had acute [GBS] and that it evolved into CIDP.” Id. at 95:22–24. He
stated, “CIDP can present in a variety of ways including an initial episode that looks like [GBS]
and patients can actually have a relapsing course of CIDP.” Id. 95:24–96:2. Dr. Bourdette stated
if petitioner “hadn’t developed POEMS, [he] would have diagnosed her as having CIDP, not
acute [GBS], but then followed by CIDP.” Id. at 96:4–6.
Dr. Bourdette addressed the case report petitioner filed for the proposition that a POEMS
syndrome patient can experience distinct GBS/CIDP prior to onset. See id. at 134:10–20.
Contrary to Dr. Latov’s interpretation, Dr. Bourdette asserted, “what they had diagnosed initially
was [GBS] was actually a manifestation of the polyneuropathy of POEMS,” and “that was part
of the reason they reported the cases, to call this to the attention of people.” Id. at 134:17–22.
Like Dr. Lipe, Dr. Bourdette also attributed petitioner’s thrombocytosis in November
2013 to POEMS syndrome. Hr’g Tr. at 136:8–18. He testified thrombocytosis is “one of the
minor symptoms of POEMS.” Id. at 104:19. Dr. Bourdette observed, “if you look at the
hematologists that ultimately diagnosed her with POEMS, one of the signs that they pointed to
was persistent thrombocytosis,” which “extended all the way back into November [2013] when
she developed her neurological problem.” Id. at 104:20–25. Dr. Bourdette also emphasized,
“[i]t was not until [petitioner] was treated for POEMS that [her platelet levels] returned to
normal.” Id. at 104:15–16.
Addressing petitioner’s response to IVIG treatment, Dr. Bourdette explained, “there are
case reports where patients have had a subacute onset of their POEMS-related neuropathy,
improving transiently with a course of IVIG,” but he acknowledged, “it’s well accepted that
[IVIG] is not a good or effective treatment for treating fully-established POEMS.” Id. at 97:12–
16. Nevertheless, Dr. Bourdette did not consider “that that is a reason to say that she had [GBS]
unrelated to as-yet-to-be-diagnosed POEMS syndrome.” Id. at 97:18–21.
Dr. Bourdette also opined petitioner’s medical theory of causation was “speculative.”
Hr’g Tr. at 108:14. Responding to Dr. Latov’s theory, Dr. Bourdette stated Dr. Latov
“acknowledge that [it had not] been established that vaccines could cause POEMS, and there
weren’t reports of that.” Id. at 108:21–22. Further, Dr. Bourdette stated Dr. Latov “also
acknowledged that vaccinations . . . had not been shown to cause a monoclonal gammopathy.”
Id. at 108:23–25. Dr. Bourdette, recalling Dr. Latov’s testimony, stated “it would be a reportable
first time, to report this series of events as a cause of POEMS. So I think that’s an interesting
speculation, but I think it’s not well grounded in the medical literature.” Id. at 108:25–109:4.
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Dr. Bourdette was similarly unaware of any published articles supporting Dr. Latov’s theory
concerning the cause of POEMS because “[t]he cause of POEMS remains unknown.” Id. at
138:3–4.
2. The Special Master’s Decision Denying Compensation
On 19 December 2019, Special Master Dorsey issued her decision denying compensation
because petitioner “failed to provide preponderant evidence that the flu vaccine she received on
October 1, 2013, caused her injuries.” R.S., 2019 WL 7631017, at *1.
The Special Master began by stating “[a]lthough the parties agree that petitioner was
appropriately diagnosed with POEMS syndrome, they firmly dispute the onset of the condition,
as well as the appropriate diagnosis for her neuropathy-related symptoms in October and
November 2013.” Id. at *29. Although “[b]oth sides devoted time at hearing to addressing
whether vaccine-induced GBS could be shown to cause POEMS syndrome,” the Special Master
indicated, “[t]he medical records in this case, however, suggest a more pertinent question:
whether petitioner GBS at all.” Id. She reasoned, “[t]he medical theory of causation proffered
by petitioner hinges on the undersigned finding that her neuropathy-related symptoms in October
and November 2013 are attributable to a GBS diagnosis, not POEMS. Therefore, if petitioner
did not suffer from GBS at the outset, then her claim cannot succeed.” Id.
The Special Master first considered “whether [petitioner] has established, by a
preponderance of the evidence, that she suffered from GBS as a precursor illness to her later-
diagnosed POEMS syndrome.” Id. The Special Master noted, “[a]s Federal Circuit precedent
establishes, in certain cases it is appropriate to determine the nature of a petitioner’s injury before
engaging in the Althen analysis.” Id. (citing Broekelschen v. Sec’y of Dept. of Health & Human
Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010)). The Special Master stated, “[i]t is indisputable
that petitioner’s treaters considered both GBS and CIDP diagnoses over the course of her illness
and followed the appropriate treatment protocol for both diseases.” R.S., 2019 WL 7631017, at
*29. Weighing the record evidence, the Special Master determined “[a]lthough there is earlier-
in-time evidence in the medical records interpreting petitioner’s course as GBS, and CIDP
thereafter, those records by themselves, viewed in retrospect, suggest that petitioner more likely
than not suffered from POEMS syndrome at the outset, rather than GBS or CIDP.” Id. In
support, the Special Master explained that petitioner’s “symptoms remained persistent through
2014, despite receiving treatment for presumed GBS and later CIDP, a fact that Dr. Lipe relied
upon in opining that petitioner likely had POEMS syndrome from the early stages.” Id. The
Special Master similarly reasoned that “laboratory testing, followed by an alteration of
petitioner’s treatment, also strongly supports the POEMS diagnosis.” Id.
Addressing petitioner’s preferred diagnosis, the Special Master stated petitioner’s
“experts seemingly posit that greater weight should be given to the views of her early-in-time
treating physicians who made the initial GBS/CIDP diagnoses, despite the fact that petitioner’s
later-in-time treatment evaluations took into account her persistent and evolving symptoms.” Id.
at *30. Similarly, the Special Master noted, “[t]here is no evidence in the record suggesting that
any other treating physicians who saw petitioner after the POEMS diagnosis was established
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disagreed with the conclusions regarding her ultimate diagnosis, or posited that any precursor
illness, like GBS, was appropriate.” Id.
The Special Master found “Dr. Lipe’s interpretation of the above-referenced records
regarding disease onset and progression was ultimately more persuasive.” R.S., 2019 WL
7631017, at *30. The Special Master emphasized, “Dr. Lipe based her opinion on a complete
review of the record in light of petitioner’s entire course.” Id. For example, “[h]aving treated
multiple POEMS patients, she observed that a patient may experience neuropathy-related
symptoms long before they are actually diagnosed with POEMS and even before such a
diagnosis might be proper based on the diagnostic criteria.” Id.
The Special Master also considered Dr. Lipe’s testimony “more persuasive in identifying
inconsistencies in petitioner’s history that prolonged the initial POEMS syndrome diagnosis.”
Id. For example, Dr. Lipe’s “reading of petitioner’s contemporaneous SPEP test results, . . .
pointed out that early symptoms and testing actually supported a suspicion for a POEMS
diagnosis prior to the date documented in the record.” Id.
In contrast, “petitioner’s experts failed to establish a reasonable explanation for
petitioner’s course in light of her complete medical history.” Id. Further, “Drs. Latov and
Parekh generally found more significant the initial GBS/CIDP diagnoses and the IVIG treatment
she received thereafter without explaining the subsequent changes in her course and overall
improvement following treatment for POEMS syndrome.” R.S., 2019 WL 7631017, at *30.
The Special Master accordingly determined Dr. Lipe “convincingly offered an
interpretation of the medical history that petitioner has not rebutted. It is thus improbable that
petitioner suffered from distinct GBS as a precursor illness to her later-diagnosed POEMS
syndrome.” Id. at *31.
Next, applying the three-pronged test for causation the Federal Circuit articulated in
Althen, the Special Master asserted, “[the] conclusion that petitioner likely 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
requires a finding that she experienced vaccine-induced GBS.” Id. The Special Master
nonetheless “consider[ed] the evidence offered by petitioner in support of the first Althen prong
under the assumption that petitioner offered preponderant evidence in support of a GBS
diagnosis.” Id.
Analyzing the first prong, the Special Master observed, “[t]he molecular mimicry theory
has been accepted in the Vaccine Program as a reliable explanation for how the flu vaccine can
initiate an autoimmune process resulting in GBS.” Id. at *32. The Special Master noted, “Drs.
Latov and Parekh propose that the chronic stimulation of B-cells can cause the body to produce
an abundance of plasma cells,” but indicated “[t]he medical articles offered in support, however,
do not support this assertion.” Id. Moreover, “[p]etitioner’s expert, Dr. Latov, even
acknowledged at hearing that petitioner’s case would be the first reported instance of POEMS
syndrome occurring as a direct result of GBS/CIDP via the mechanism posited herein.” R.S.,
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2019 WL 7631017, at *32. The Special Master therefore determined “[s]uch a novel theory,
without more persuasive scientific evidence, does not rise to the level of sound and reliable.” Id.
The Special Master similarly found petitioner failed to satisfy the second Althen prong
because “[w]ithout being able to establish a reliable medical theory, or that she suffered from
GBS, petitioner cannot show that the vaccine more likely than not caused her illness thereafter.”
Id. at *33. The Special Master stressed that “[f]ollowing her diagnosis with POEMS, no treaters
appear to have embraced an association between the flu vaccine and petitioner’s subsequent
development of POEMS.” Id. at *33.
Lastly, analyzing the third Althen prong, the Special Master suggested “[t]here is support
in the relevant medical literature for the conclusion that the timeframe between vaccination and
petitioner’s subsequent symptoms was medically acceptable—assuming she suffered from GBS
as she alleges.” Id. The Special Master determined, however, “petitioner has not established
that she more likely than not suffered from GBS at the outset of her illness.” Id. at *34. Lastly,
the Special Master reasoned, “even if petitioner had accepted the conclusion that her symptoms
in October and November 2013 were indicative of POEMS, and argued that it was caused by her
receipt of the flu vaccine, there would still be a lack of medically-acceptable temporal
relationship, due to the fact that neither Dr. Latov nor Dr. Parekh proposed that vaccinations
could cause POEMS syndrome at all let alone offered some medically cognizable timeframe for
such an injury.” R.S., 2019 WL 7631017, at *34.
For these reasons, the Special Master determined petitioner did not establish causation
and accordingly was not entitled to compensation under the Vaccine Program. Id.
3. Petitioner’s Motion for Review
On 21 January 2020, petitioner filed her pro se motion for review.8 See Pet’r’s Mot. for
Review, ECF No. 144. The filing contains: (1) an incomplete, two-page outline of a formal
brief moving for review of the Special Master’s decision with a handwritten note, stating “please
see attached document;” (2) an attached memorandum listing 11 bullet points detailing factual
disagreements with the Special Master’s decision; and (3) an addendum to the memorandum
with fourteen additional factual disagreements with citations to the Special Master’s decision.
See id. The factual disagreements focus on petitioner’s fundamental challenge to the Special
Master’s holding that petitioner did not prove by preponderant evidence that petitioner had GBS.
See generally id. at 3–8. Petitioner argues although “[t]he Special Master concluded that
[petitioner] never had GBS, a diagnosis in the Vaccine Injury table[,] . . . all of her care providers
and the preponderance of evidence suggests otherwise.” Id. at 3. Concerning the medical theory
of causation, petitioner recognizes “[t]he possible association between GBS and POEMS was
less clear,” but because the cause of POEMS is unknown, she posits, “[i]t seems therefore more
than coincidental that a previously healthy 41 year old woman would develop POEMS after GBS
after a flu vaccine.” Id.
8 Petitioner was previously represented by counsel throughout the proceedings before the Special Master, but on 13
January 2020, petitioner’s counsel moved to withdraw as attorney of record. See Mot. to Withdraw as Att’y of R.,
ECF No. 141. The Special Master granted the motion to withdraw on 22 January 2020, and petitioner proceeded
representing herself. See Order, ECF No. 145.
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On 18 February 2020, respondent filed its response to petitioner’s motion for review. See
Resp’t’s Resp. to Pet’r’s Mot. for Review, ECF No. 153. Respondent argues “[p]etitioner does
not assert that the special master’s findings were arbitrary or capricious. . . . [S]he simply details
her disagreements with particular findings of fact made by the special master, and requests that
this Court reconsider specific evidence already considered by the special master, but reach a
different conclusion.” Id. at 14. Pointing to Dr. Bourdette’s and Dr. Lipe’s testimony,
respondent contends “the special master correctly concluded that respondent’s experts were more
persuasive, in large part because their opinions were based on the medical records in their
entirety, considering petitioner’s final diagnosis of POEMS and working backwards, as opposed
to petitioner’s experts, who considered petitioner’s initial diagnosis of GBS and later diagnosis
of POEMS as isolated events.” Id. at 15. Additionally, respondent argues “[p]etitioner does not
appear to assert that the special master erred in reaching her conclusion that petitioner had not
established that GBS can cause POEMS syndrome, but again improperly requests that this Court
reach a different conclusion, based on the same evidence considered by the special master.” Id.
at 18. Respondent emphasizes Dr. Latov’s testimony “acknowledging that petitioner’s case
would be the first instance of POEMS syndrome occurring as a direct result of GBS/CIDP via
the mechanism he posited . . . [which] support[s] the special master’s determination that
petitioner failed to demonstrate a logical sequence of cause and effect.” Id. at 19. Lastly,
respondent maintains “without the ability to establish a reliable medical theory, or that she
actually suffered from GBS, petitioner could not show that her flu vaccination more likely than
not caused her POEMS syndrome.” Id.
III. Discussion
A. Legal Standards
i. The Court’s Standard of Review of a Special Master’s Decision
The Vaccine Act provides this Court jurisdiction to review a Special Master’s decision
upon timely motion of either party. See 42 U.S.C. § 300aa-12(e)(1)–(2). In reviewing the record
of the proceedings before the Special Master, the Court may: (1) “uphold the findings of fact
and conclusions of law of the special master and sustain the special master’s decision;” (2) “set
aside any findings of fact or conclusion of law of the special master found to be arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own
findings of fact and conclusions of law;” or (3) “remand the petition to the special master for
further action in accordance with the court’s direction.” Id. § 300aa-12(e)(2). “Fact findings are
reviewed . . . under the arbitrary and capricious standard; legal questions under the ‘not in
accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.”
Saunders v. Sec’y of Dept. of Health & Human Servs., 25 F.3d 1031, 1033 (Fed. Cir. 1994)
(quoting Munn v. Sec’y of Dept. of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.
1992)).
It is not the Court’s role “to reweigh the factual evidence, or to assess whether the special
master correctly evaluated the evidence.” Lampe v. Sec’y of Dept. of Health & Human Servs.,
219 F.3d 1357, 1360 (Fed. Cir. 2000) (quoting Munn, 970 F.2d at 871)). The Court also does
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“not examine the probative value of the evidence or the credibility of the witnesses. These are
all matters within the purview of the fact finder.” Id. (quoting Munn, 970 F.2d at 871).
“Reversal is appropriate only when the special master’s decision is arbitrary, capricious, an
abuse of discretion, or not in accordance with the law.” Snyder ex rel. Snyder v. Sec’y of Dept. of
Health & Human Servs., 88 Fed. Cl. 706, 718 (2009). The arbitrary and capricious standard is a
“highly deferential standard of review:” “[i]f the special master has considered the relevant
evidence of record, drawn plausible inferences and articulated a rational basis for the decision,
reversible error will be extremely difficult to demonstrate.” Hines ex rel. Sevier v. Sec’y of Dept.
of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991).
ii. The Standard of Causation in Vaccine Cases
“A petitioner seeking compensation under the Vaccine Act must prove by a
preponderance of the evidence that the injury or death at issue was caused by a vaccine.”
Broekelschen v. Sec’y of Dept. of Health & Human Servs., 618 F.3d 1339, 1341 (Fed. Cir. 2010)
(citing 42 U.S.C. §§ 300aa-11(c)(1)). “A petitioner can show causation under the Vaccine Act in
one of two ways:” (1) “by showing that she sustained an injury in association with a vaccine
listed in the Vaccine Injury Table,” in which case “causation is presumed;” or (2) “if the
complained-of injury is not listed in the Vaccine Injury Table . . . the petitioner may seek
compensation by proving causation in fact.” Id. at 1341–42 (internal citations omitted). Vaccine
cases employ a burden shifting standard: “[o]nce the petitioner has demonstrated causation, she
is entitled to compensation unless the government can show by a preponderance of the evidence
that the injury is due to factors unrelated to the vaccine.” Id. at 1342 (citing Doe v. Sec’y of
Dept. of Health & Human Servs., 601 F.3d 1349, 1351 (Fed. Cir. 2010); 42 U.S.C. § 300aa-
13(a)(1)(B)).
“When a petitioner has suffered an off-Table injury, as is the case here, [the Federal
Circuit] has established the following test for showing causation in fact under the Vaccine Act:”
[The petitioner’s] burden is to show by preponderant evidence that the vaccination
brought about her injury by providing: (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. at 1345 (quoting Althen v. Sec’y of Dept. of Health & Human Servs., 418 F.3d 1274, 1278
(Fed. Cir. 2005)). Under the first prong, “[a] petitioner must provide a ‘reputable medical or
scientific explanation’ for its theory.” Boatmon v. Sec’y of Dept. of Health & Human Servs., 941
F.3d 1351, 1359 (Fed. Cir. 2019) (quoting Moberly ex rel. Moberly v. Sec’y of Dept. of Health &
Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)). “While it does not require medical or
scientific certainty, it must still be ‘sound and reliable.’” Id. (quoting Knudsen ex rel. Knudsen v.
Sec’y of Dept. of Health & Human Servs., 35 F.3d 543, 548–49 (Fed. Cir. 1994)). Petitioners
“need not produce medical literature or epidemiological evidence to establish causation under the
Vaccine Act.” Andreu ex rel. Andreu v. Sec’y of Dept. of Health & Human Servs., 569 F.3d
1367, 1379 (Fed. Cir. 2009). Where such evidence is introduced, however, it must not be viewed
“through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s
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preponderant evidence standard.” Id. at 1380. To demonstrate a logical sequence, “medical
records and medical opinion testimony are favored in vaccine cases, as treating physicians are
likely to be in the best position to determine whether ‘a logical sequence of cause and effect
show[s] that the vaccination was the reason for the injury.’” Capizzano v. Sec’y of Dept. of
Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (quoting Althen, 418 F.3d at
1280). Lastly, “the proximate temporal relationship prong requires preponderant proof that the
onset of symptoms occurred within a timeframe for which, given the medical understanding of
the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y
of Dept. of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
iii. Pro Se Litigants
A pro se plaintiff’s pleadings are held to “less stringent standards than formal pleadings
drafted by lawyers.” Haines v. Kerner, 404 U.S. 519, 520–21 (1972). Nonetheless, courts have
long recognized “[a]lthough pro se plaintiffs are given some leniency in presenting their case,
their pro se status does not immunize them from pleading facts upon which a valid claim can
rest.” Hutchens v. United States, 89 Fed. Cl. 553, 560 (2009). If a petitioner acts pro se in the
drafting of her pleading it “may explain its ambiguities, but it does not excuse its failures, if such
there be.” Henke v. United States, 60 F.3d 795, 799 (Fed. Cir. 1995).
B. Analysis
Petitioner argues the Special Master erred in concluding petitioner did not establish she
suffered from GBS, and in doing so, the Special Master “chose to believe the speculative claims
of one government witness over the clear evidence in the medical records and over the expertise
of 5 neurologists.” Pet’r’s Mot. for Review at 3. While petitioner acknowledges “[t]he possible
association between GBS and POEMS [is] less clear, as there is only one report in the medical
literature (from Poland) linking the two,” petitioner asserts her witnesses “described a plausible
biologic mechanism by which the chronic stimulation of plasma cells from GBS could, in theory,
precipitate the formation of a plasma cell neoplasm.” Id. Since “[t]here is no other known
etiology for POEMS,” petitioner argues “the experts’ theory is at least as plausible as any.” Id.
Petitioner lists eleven disagreements with the Special Master’s factual findings:
1) POEMS is not an illness of acute onset as occurred in [petitioner’s] case.
2) POEMS causes weakness but generally not paralysis and certainly not within
the course of hours as GBS typically does.
3) The neuropathy of POEMS does not typically follow an ascending pattern as
[petitioner] had and as is typical of GBS.
4) There are anecdotal reports of POEMS patients responding to treatment with
IVIG. Typically they do not . . . . In the rare patient with POEMS who might
respond, it would be expected that the response would be maintained. [Petitioner]
responded dramatically well to her first two courses of IVIG and then upon her
third episode of neuropathy, her response was minimal to nil. . . .
5) [Petitioner’s] initial SPEP was normal. . . . [I]t more likely would have been
negative as she had GBS . . . .
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6) [Petitioner’s] several initial EMG studies showed preservation of the sural nerve.
This is typical and expected in GBS. . . . On a subsequent EMG at MGH (Dr. Chad),
she “lost” her sural nerve. While not much was made of this at the time, I believe
it is a very critical finding to suggest that what started as GBS became something
else.
7) [Petitioner’s] most prominent and dangerous symptoms of POEMS – increased
intracranial pressure with visual impairment and profound weight loss – were not
present early on in the course of her disease. These are not seen with GBS but are
seen with POEMS Syndrome.
8) [Petitioner’s] thrombocytosis was argued to be a sign that she had POEMS from
the start by Dr. Lipe. Thrombocytosis is associated with POEMS but is also a
common acute phase reactant. . . . [I]t was not until 8/14 that the ongoing presence
of [the high platelet count] (in the absence of further acute medical events) triggered
a Hematology consult at MGH which led to the discovery of POEMS. However
that does not mean she had POEMS all along.
9) 50% of GBS patients have pain. . . . The argument that pain suggests against the
initial diagnosis of GBS is in error . . . .
10) Swallowing can be affected by GBS. . . .
11) Hemangiomas were present early in her disease, in fact even before her initial
illness. GLOMERULOID hemangiomas are specific to POEMS Syndrome.
[Petitioner] had a Dermatologist remove one and it was the sporadic type, not the
glomeruloid type. . . . [T]he early presence of hemangiomas . . . are not indicative
of her having had POEMS earlier than when her POEMS diagnosis was made.
Id. at 3–4.
Respondent counters, arguing, “petitioner does not assert that the special master’s
findings were arbitrary or capricious. On review, she simply details disagreements with
particular findings of fact made by the special master, and requests that this Court reconsider
specific evidence already considered by the special master, but reach a different conclusion.”
Resp’t’s Resp. to Pet’r’s Mot. for Review at 14. Respondent first acknowledges petitioner’s
“theory of causation hinges on the premise that she suffered from vaccine-related GBS/CIDP
that caused her to develop POEMS syndrome,” and argues “[t]he special master properly held
that petitioner was not entitled to compensation primarily because she failed to establish by
preponderant evidence that she suffered from GBS.” Id. The Special Master, according to
respondent, “correctly concluded that respondent’s experts were more persuasive, in large part
because their opinions were based on the medical records in their entirety, considering
petitioner’s final diagnosis of POEMS and working backwards, as opposed to petitioner’s
experts, who considered petitioner’s initial diagnosis of GBS and later diagnosis of POEMS as
isolated events.” Id. at 15. Respondent also argues “[p]etitioner does not appear to assert that
the special master erred in reaching her conclusion that petitioner had not established that GBS
can cause POEMS syndrome, but again improperly requests that this Court reach a different
conclusion, based on the same evidence considered by the special master.” Id. at 18.
Respondent maintains the Special Master’s “decision carefully considered the literature relied
upon by petitioner’s experts to support their theory and concluded that none [of] the articles
offered by petitioner’s experts associate chronic immune stimulation pathologically with the
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onset of POEMS.” Id. at 19. Accordingly, respondent argues “without the ability to establish a
reliable medical theory, . . . petitioner could not show that her flu vaccination more likely than
not caused her POEMS syndrome.” Id.
1. Whether the Special Master’s Finding that Petitioner Suffered From POEMS
From the Outset of Her Injury Was Arbitrary or Capricious
Petitioner first challenges the Special Master’s finding that petitioner suffered from
POEMS—not GBS—from the outset of her injury in late 2013. Petitioner argues, “all of her
care providers and the preponderance of evidence suggests otherwise.” Pet’r’s Mot. for Review
at 3. In addition, “[t]he Special Master chose to believe the speculative claims of one
government witness over the clear evidence in the medical records and over the expertise of 5
Neurologists . . . .” Id. Respondent argues, on the other hand, “the special master offered
entirely rational reasons for finding the testimony of respondent’s experts more persuasive on the
issue of whether petitioner suffered from GBS.” Resp’t’s Resp. to Pet’r’s Mot. for Review at 18.
The experts agreed petitioner suffers from POEMS syndrome, but they disagreed whether
petitioner suffered from GBS as a precursor condition that then caused petitioner’s POEMS
syndrome. During the hearing, Dr. Latov opined petitioner “had GBS which then evolved to
CIDP, . . . [a]nd she probably had POEMS syndrome and CIDP concurrently until she developed
more obvious manifestations of POEMS syndrome.” Hr’g Tr. at 23:4–8. Dr. Latov maintained
that petitioner’s early symptoms could not be attributed to her later-diagnosed POEMS
syndrome; rather, he opined they were two separate disease courses. See id. at 42:20–24; 55:4–7
(“Although she subsequently did develop POEMS, at some point, and we don’t know exactly
when, but it certainly wasn’t within the . . . period of response to IVIG.”). Dr. Latov explained
IVIG treatment is beneficial to patients with CIDP-associated monoclonal gammopathy, but not
POEMS-associated monoclonal gammopathy; this led him to opine petitioner’s initial
improvement with IVIG treatment was indicative of GBS in contrast with her later worsening
condition that did not respond to IVIG treatment. See id. at 37:17–38:8, 54:23–55:8. Dr. Latov
similarly distinguished petitioner’s early neuropathy from her later POEMS syndrome symptoms
to suggest petitioner initially had GBS because her initial disease onset was acute, unlike
POEMS, which “comes on very slowly.” Id. at 55:14–16; see also id. at 57:12–16 (“I think
they’re distinct, again, because of the rapid onset and response to treatment which usually when
POEMS responds to treatment, . . . it takes months before the neuropathy starts getting better.”).
Dr. Parekh similarly opined petitioner’s “initial presentation was characterized by an ascending
neurological deficit,” which he contended “is more characteristic of GBS than of POEMS
syndrome.” Id. at 246:25–247:2. Further, although Dr. Parekh acknowledged petitioner’s
platelet levels returned to normal once she was treated for POEMS syndrome and
thrombocytosis is a minor criteria for POEMS, he nonetheless considered petitioner’s
thrombocytosis a “nonspecific finding” because “it can happen from very many causes.” Id. at
245:15–246:16.
Dr. Lipe, in contrast, presented a more inclusive assessment of petitioner’s condition,
opining that petitioner “had POEMS from the outset of her symptoms.” Hr’g Tr. at 260:17–18.
First, Dr. Lipe stated, “[m]ost of the reports that we have of POEMS syndrome and any patient
studies that we have suggest that patients are initially misdiagnosed, and the primary
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misdiagnosis is either CIDP or AIDP,” but “they are ultimately diagnosed with POEMS,” which
she suggests “happened in this case.” Id. at 260:18–25. One article Dr. Lipe cited showed 60%
of patients studied “were initially diagnosed with CIDP and received IVIg therapy,” while
another article Dr. Lipe cited “says that 85 percent of patients were initially misdiagnosed.” Id.
at 261:3–8. Moreover, once a patient is diagnosed with POEMS, patients are not considered to
still suffer from GBS or CIDP. Id. at 261:15–17. Dr. Lipe also asserted she was “not aware of
any coexisting literature or evidence to suggest that you can have a distinct GBS and a distinct
POEMS that are not related.” Id. at 262:11–13. Dr. Lipe observed petitioner’s presentation was
not “atypical compared to the other patients with POEMS” whom she treated. Id. at 267:24–
268:1. Responding to Dr. Latov’s and Dr. Parekh’s distinction between petitioner’s acute onset
and the slower progression of POEMS syndrome symptoms, Dr. Lipe asserted “it’s accepted that
[POEMS] can present acutely[;] . . . the fact that it came on quickly with her symptoms and that
she quickly deteriorated is not inconsistent with what I have either personally seen or read.” Id.
at 268:9–13. Ultimately, Dr. Lipe placed the onset of petitioner’s POEMS syndrome at
November 2013, when she began exhibiting POEMS syndrome symptoms, such as neuropathies,
thrombocytosis, pain, and lower extremity edema. See id. at 282:12–284:5.
To the extent petitioner challenges the Special Master’s finding that petitioner suffered
from POEMS, rather than GBS, “the function of a special master is not to ‘diagnose’ vaccine-
related injuries, but instead to determine ‘based on the record evidence as a whole and the
totality of the case, whether it has been shown by a preponderance of the evidence that a vaccine
caused the [petitioner’s] injury.’” Andreu, 569 F.3d at 1382 (quoting Knudsen, 35 F.3d at 549).
The Special Master found petitioner did not demonstrate by a preponderance of the evidence that
petitioner suffered from GBS, as opposed to POEMS. The Special Master stated, “[a]lthough
there is earlier-in-time evidence in the medical records interpreting petitioner’s course as GBS,
and CIDP thereafter, those records by themselves, viewed in retrospect, suggest that petitioner
more likely than not suffered from POEMS syndrome at the outset, rather than GBS or CIDP.”
R.S., 2019 WL 7631017, at *29. The Special Master first considered the medical records, which
showed petitioner continued suffering relapses of symptoms, “despite receiving treatment for
presumed GBS and later CIDP.” Id. The Special Master noted, “[b]ecause GBS/CIDP and
POEMS can be confused in their initial presentations, it is not surprising that the treating
physicians who first saw petitioner in late 2013 reached different conclusions from those treating
her later, in August 2014.” Id. Moreover, the Special Master observed it was not until petitioner
was treated for POEMS that her condition improved. See id. In finding the evidence
preponderated in favor of a POEMS diagnosis, the Special Master found Dr. Lipe’s
interpretation of petitioner’s medical records more persuasive because Dr. Lipe “based her
opinion on a complete review of the record in light of petitioner’s entire course,” in contrast with
petitioner’s experts, who “placed too much emphasis on petitioner’s earlier-in-time records and
treatment responses.” Id. at 30, 38.
Petitioner lists disagreements with the Special Master’s factual findings to argue in favor
of a GBS diagnosis. These disagreements concern petitioner’s medical history and whether they
are properly attributed to GBS and POEMS. Such disagreements, however, seek this Court’s
reweighing of the evidence, which the Special Master already considered. “[I]t is not . . . the role
of this court to reweigh the factual evidence, or to assess whether the special master correctly
evaluated the evidence.” Munn, 970 F.2d at 871. “‘[A]rbitrary and capricious’ is a highly
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deferential standard of review. If the special master has considered the relevant evidence of
record, drawn plausible inferences and articulated a rational basis for the decision, reversible
error will be extremely difficult to demonstrate.” Hines, 940 F.2d at 1528; see also Lampe, 219
F.3d at 1360 (“The arbitrary and capricious standard of review is difficult for an appellant to
satisfy with respect to any issue, but particularly with respect to an issue that turns on the
weighing of evidence by the trier of fact.”). The Special Master thoroughly reviewed the
evidence but was ultimately persuaded by Dr. Lipe’s testimony in light of petitioner’s medical
history.
To the extent petitioner challenges the Special Master’s reliance on Dr. Lipe’s expert
opinion over that of petitioner’s experts, “this court accords great deference to a Special Master’s
determination on the probative value of evidence and the credibility of witnesses.” Pafford v.
Sec’y of Dept. of Health & Human Servs., 451 F.3d 1352, 1359 (Fed. Cir. 2006). “The fact-
finder has broad discretion in determining credibility because [she] saw the witnesses and heard
the testimony.” Bradley v. Sec’y of Dept. of Health & Human Servs., 991 F.2d 1570, 1575 (Fed.
Cir. 1993). Indeed, a Special Master’s “credibility determinations are ‘virtually unreviewable.’”
Hanlon v. Sec’y of Dept. of Health & Human Servs., 191 F.3d 1344, 1349 (Fed. Cir. 1999)
(quoting Bradley, 991 F.2d at 1575)). Moreover, the Special Master provided reasonable
explanation why Dr. Lipe’s testimony was more persuasive than petitioner’s experts; namely,
“Dr. Lipe based her opinion on a complete review of the record in light of petitioner’s entire
course.” R.S., 2019 WL 7631017, at *30. Petitioner’s experts, on the other hand, “failed to
establish a reasonable explanation for petitioner’s course in light of her complete medical
history” and “were selective in their interpretation of petitioner’s multitude of symptoms.” Id. at
*31. Considering petitioner’s medical history as a whole is especially important because, as the
Special Master noted, “POEMS patients are routinely misdiagnosed with conditions similar to
GBS.” Id. Accordingly, based on Dr. Lipe’s testimony as well as the medical records and
literature, the Special Master’s determination that petitioner suffered from POEMS syndrome
was not arbitrary and capricious. Cedillo v. Sec’y of Dept. of Health & Human Servs., 617 F.3d
1328, 1338 (Fed. Cir. 2010) (quoting Lampe, 219 F.3d at 1363) (“We ‘do not sit to reweigh
evidence. [If] the Special Master’s conclusion [is] based on evidence in the record that [is] not
wholly implausible, we are compelled to uphold that finding as not arbitrary or capricious.’”).
2. Whether the Special Master’s Finding that Petitioner Failed to Establish the Flu
Vaccine Could Cause GBS and Subsequently POEMS Was Arbitrary or
Capricious
Petitioner acknowledges “[t]he possible association between GBS and POEMS [is] less
clear, as there is only one report in the medical literature (from Poland) linking the two,” but
asserts “we are dealing with an exceedingly rare disease for which causation is unknown.”
Pet’r’s Mot. for Review at 3. Petitioner highlights her experts’ testimony, which “described a
plausible biologic mechanism by which the chronic stimulation of plasma cells from GBS could,
in theory, precipitate the formation of a plasma cell neoplasm.” Id. Petitioner therefore argues
“the experts’ theory is at least as plausible as any” because “[t]here is no other known etiology
for POEMS.” Id. Respondent asserts, “[o]n review, petitioner acknowledges that the potential
relationship between GBS and POEMS syndrome is more speculative” and argues “[p]etitioner
does not appear to assert that the special master erred in reaching her conclusion that petitioner
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had not established that GBS can cause POEMS syndrome.” Resp’t’s Resp. to Pet’r’s Mot. for
Review at 18. Instead, respondent contends, petitioner “again improperly requests that this Court
reach a different conclusion, based on the same evidence considered by the special master.” Id.
Reviewing the record, Dr. Parekh relies on the Lindqvist article to establish a purported
connection between GBS and POEMS syndrome. See Hr’g Tr. at 239:6–8; see generally Pet’r’s
Ex. 59, ECF No. 76-1. The Lindqvist paper is an epidemiological study of monoclonal
gammopathy and myeloma patients, which “found that immune or autoimmune conditions
increase the risk of plasma cell dyscrasias.” Hr’g Tr. at 239:13–15. The paper listed “a number
of autoimmune conditions associated with increase in plasma cell dyscrasias,” including GBS.
Id. at 239:15–18. Dr. Parekh posited that “chronic immune stimulation leads to plasma cell
dyscrasia,” and POEMS is a form of plasma cell dyscrasia. Id. at 240:5–7. Dr. Parekh testified
the Lindqvist article stands for the proposition that autoimmune conditions are associated with
“an increased risk of developing [monoclonal gammopathy of unknown significance (“MGUS”)]
of almost three-fold.” Id. at 239:20. Dr. Parekh acknowledged, though, the Lindqvist article
does not make an association between GBS and POEMS. Id. at 253:5–9.
Dr. Lipe, on the other hand, detailed several issues with the Lindqvist study. First, Dr.
Lipe noted the study “started with a group of patients with MGUS,” which is an “asymptomatic
disease” that “is generally not detected.” Id. at 273:15–20. Dr. Lipe explained this is
problematic because MGUS is typically only found when patients are tested for another
underlying condition, and the study did not account for this variable. See id. at 273:14–275:7.
Dr. Lipe next highlighted that the study found only six out of 26,000 patients studied had
concurrent monoclonal gammopathy and GBS, which she asserted “is not something that I think
anyone would suggest is evidence of pathogenesis.” Id. at 275:22–276:6. Dr. Lipe testified she
was unaware of any case reports or literature that would support a theory of causation that
chronic immune stimulation from GBS/CIDP could cause POEMS. Id. at 272:12–17.
Before applying the Althen prongs, the Special Master stated “[t]he undersigned’s
conclusion that petitioner likely 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 requires a finding that she experienced
vaccine-induced GBS.” R.S., 2019 WL 7631017, at *31. The Special Master recognized “[t]he
molecular mimicry theory has been accepted in the Vaccine Program as a reliable explanation for
how the flu vaccine can initiate an autoimmune process resulting in GBS.” Id. at *32. The
Special Master reasoned, though, that “[a]part from her inability to show that she more likely
than not suffered from GBS at the outset, however, petitioner has also failed to preponderantly
establish that chronic inflammation produced secondarily due to GBS can result in plasma cell
proliferation let alone instigate POEMS syndrome specifically.” Id. The Special Master credited
petitioner’s experts, who “propose[d] that the chronic stimulation of B-cells can cause the body
to produce an abundance of plasma cells,” but acknowledged “[t]he medical articles offered in
support . . . do not support this assertion.” Id. Moreover, “none of the articles cited by
petitioner’s experts associate chronic immune stimulation pathologically with the onset of
POEMS syndrome.” Id. Additionally, “the relevant literature offered by experts on both sides
which discusses the pathogenesis of POEMS syndrome makes no mention of immune
stimulation, whether chronic or acute, as an acceptable biologic mechanism capable of causing
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the condition.” Id. Dr. Latov “even acknowledged at hearing that petitioner’s case would be the
first reported instance of POEMS syndrome occurring as a direct result of GBS/CIDP via the
mechanism posited herein.” R.S., 2019 WL 7631017, at *32. For these reasons, the Special
Master determined “[s]uch a novel theory, without more persuasive scientific evidence, does not
rise to the level of sound and reliable.” Id. (citing Boatmon, 941 F.3d at 1360).
Petitioner’s arguments dispute the standard of reliability a medical theory must meet to
establish causation in a vaccine case. Under the first Althen prong, a petitioner must provide “a
medical theory causally connecting the vaccination and the injury.” Althen, 418 F.3d at 1278.
“A petitioner must provide a ‘reputable medical or scientific explanation’ for its theory.”
Boatmon, 941 F.3d at 1359 (quoting Knudsen, 35 F.3d at 548–49). Although this standard “does
not require medical or scientific certainty,” the theory “must still be ‘sound and reliable.’” Id.
(quoting Knudsen, 35 F.3d at 548–49). The Special Master reasoned that even if petitioner met
the burden to demonstrate she suffered from GBS at the outset, petitioner “failed to
preponderantly establish that chronic inflammation produced secondarily due to GBS can result
in plasma cell proliferation let alone instigate POEMS syndrome specifically.” R.S., 2019 WL
7631017, at *32. The Special Master considered petitioner’s experts’ testimony but observed the
medical articles they relied upon did not support the theory that the flu vaccine caused GBS,
which in turn caused POEMS. See id. The Special Master noted, “none of the articles cited by
petitioner’s experts associate chronic immune stimulation pathologically with the onset of
POEMS syndrome.” Id. Without “sound and reliable” medical or scientific literature supporting
the link of causation between petitioner’s flu vaccine, GBS, and then POEMS, all that remains is
petitioner’s experts’ testimony. See Andreu, 569 F.3d at 1379 (“[A] claimant need not produce
medical literature or epidemiological evidence to establish causation under the Vaccine Act,
[but] where such evidence is submitted, the special master can consider it in reaching an
informed judgment as to whether a particular vaccination likely caused a particular injury.”). Dr.
Latov, however, “even acknowledged at hearing that petitioner’s case would be the first reported
instance of POEMS syndrome occurring as a direct result of GBS/CIDP via the mechanism
posited herein.” R.S., 2019 WL 7631017, at *32.
The Federal Circuit has “consistently rejected theories that the vaccine only ‘likely
caused’ the injury and reiterated that a ‘plausible’ or ‘possible’ causal theory does not satisfy the
standard.” Boatmon, 941 F.3d at 1360. Petitioner’s expert describes the theory in her motion for
review as only a “plausible biologic mechanism.” Pet’r’s Mot. for Review at 3 (emphasis
added). The Special Master therefore reasonably determined “[s]uch a novel theory, without
more persuasive scientific evidence, does not rise to the level of sound and reliable.” R.S., 2019
WL 7631017, at *32. The Court accordingly finds the Special Master’s determination that
petitioner failed to provide a medical theory of causation linking the flu vaccine, GBS, and
subsequent POEMS syndrome is neither arbitrary nor capricious. Bradley, 991 F.2d at 1571
(“Because the Claims Court correctly concluded that the special master’s decision—that the
[petitioner] did not prove by a preponderance of the evidence that [the injuries] were . . . caused
by the [vaccine at issue]—was not arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with law, we affirm.”).
3. The Special Master’s Decision was Not Arbitrary and Capricious
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Petitioner’s addendum to the memorandum to the motion for review lists additional
factual disagreements, such as: (1) “I do not believe [petitioner] had monoclonal gammopathy
early on;” (2) “50% of patients with GBS manifest pain;” and (3) “she was not readmitted with
persistent symptoms but with a distinct third recurrence after prior dramatically favorable
response to IVIg.” Pet’r’s Mot. for Review at 6–8. The Court has considered each point
petitioner raises but considers them disagreements with factual assertions throughout the Special
Master’s decision. The Federal Circuit has instructed this Court to uphold a special master’s
findings of facts unless they are arbitrary or capricious, but petitioner does not argue any of the
factual disagreements are arbitrary or capricious. See Munn, 970 F.2d at 870 (“The Claims Court
owes [fact] findings and conclusions by the special master great deference—no change may be
made absent first a determination that the special master was ‘arbitrary and capricious.’”). At
best, petitioner’s disagreements point to evidence in the record against the Special Master’s fact
findings, but “it is not . . . the role of this court to reweigh the factual evidence, or to assess
whether the special master correctly evaluated the evidence.” Id. at 871.
“Congress assigned to a group of specialists, the Special Masters within the Court of
Federal Claims, the unenviable job of sorting through these painful cases and, based upon their
accumulated expertise in the field, judging the merits of the individual claims. The statute makes
clear that, on review, the Court of Federal Claims is not to second guess the Special Master’s
fact-intensive conclusions; the standard of review is uniquely deferential for what is essentially a
judicial process.” Hodges v. Sec’y of Dept. of Health & Human Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993) (citing Munn, 970 F.2d at 870)). “If the special master has considered the relevant
evidence of record, drawn plausible inferences and articulated a rational basis for the decision,
reversible error will be extremely difficult to demonstrate.” Hines, 940 F.2d at 1528.
The Court finds nothing arbitrary or capricious in the Special Master’s decision.
Reviewing the record, preponderant evidence shows petitioner suffered from POEMS from the
outset of her injury rather than GBS. Further, petitioner failed to demonstrate through a sound
and reliable medical theory that the flu vaccine caused petitioner’s GBS and subsequent POEMS.
To the extent petitioner can point to evidence showing otherwise, simply identifying opposing
evidence does not rise to the level of arbitrary and capricious required to disturb the Special
Master’s decision. These findings were well supported by the medical records, medical
literature, and expert testimony. Accordingly, the Special Master’s decision was not “arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law.” Cedillo v. Sec’y of
Dept. of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010) (quoting Lampe, 219
F.3d at 1363) (“We ‘do not sit to reweigh evidence. [If] the Special Master’s conclusion [is]
based on evidence in the record that [is] not wholly implausible, we are compelled to uphold that
finding as not arbitrary or capricious.’”).
III. Conclusion
For the foregoing reasons, the Court SUSTAINS the Special Master’s decision because it
was not arbitrary, capricious, or not otherwise in accordance with law. The Court therefore
DENIES petitioner’s motion for review. The Clerk of Court is directed to enter judgment for
respondent.
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IT IS SO ORDERED.
s/ Ryan T. Holte
RYAN T. HOLTE
Judge
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