Lucero v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

Filed: February 20, 2026

* * * * * * * * * * * * * * *

ANNETTE DANIELLE LUCERO, *

*

Petitioner, * No. 20-1789V

*

v. * Special Master Young

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

* * * * * * * * * * * * * * *

Renee Ja Gentry, The Law Office of Renne J. Gentry, Washington, DC, for Petitioner.

Mary Eileen Holmes, United States Department of Justice, Washington, DC, for Respondent.

DECISION ON ENTITLEMENT1

On December 7, 2020, Annette Danielle Lucero (“Petitioner”) filed a petition for

compensation in the National Vaccine Injury Compensation Program (“the Program”).2 Pet., ECF

No. 1. Petitioner alleged that she received an influenza (“flu”) vaccination on November 21, 2018,

and “thereafter suffered a Table Injury known as Guillain-Barré Syndrome (“GBS”),[3] and

1

Because this Decision contains a reasoned explanation for the action taken in this case, it must be made

publicly accessible and will be posted on the United States Court of Federal Claims’ website, and/or at

https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act

of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government

Services). This means the Decision will be available to anyone with access to the internet. In

accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or

other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon

review, I agree that the identified material fits within this definition, I will redact such material from

public access.

2

National Childhood Vaccine Injury Act of 1986, Pub L. No. 99-660, 100 Stat. 3755 (“the Vaccine Act”

or “Act”). Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent

subparagraph of 42 U.S.C. § 300aa (2018).

3

GBS is a “rapidly progressive ascending motor neuron paralysis.” Guillain-Barré Syndrome,

DORLAND’S MED. DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=110689

(last visited Feb. 17, 2026) (hereinafter “DORLAND’S”). “It begins with paresthesias of the feet, followed

by flaccid paralysis of the entire lower limbs, ascending to the trunk, upper limbs, and face; other

characteristics include slight fever, bulbar palsy, absent or lessened tendon reflexes, and increased protein

in the cerebrospinal fluid without a corresponding increase in cells.” Id.

Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”),[4] which were caused-in-fact by

the vaccination.”5 Id. at Preamble. Petitioner later added a significant aggravation claim in her

motion for a ruling on the record but did not file an amended petition. Pet’r’s Mot. at 2, ECF No.

40.

A careful analysis and weighing of all the evidence and testimony presented in this case in

accordance with the applicable legal standards,6 reveals that Petitioner has failed to provide

preponderant evidence that the flu vaccine she received on November 21, 2018, caused her to

develop GBS or CIDP or significantly aggravate her GBS or CIDP. Accordingly, Petitioner is not

entitled to an award of compensation.

I. Procedural History

Petitioner filed her petition, an affidavit, and medical records on December 7, 2020. Pet.;

Pet’r’s Exs. 1–6, ECF No. 1. Petitioner filed additional medical records on December 17, 2020,

and August 24, 2021. Pet’r’s Ex. 7, ECF No. 7; Pet’r’s Ex. 8, ECF No. 18. On November 1, 2021,

Respondent filed his Rule 4(c) report arguing against compensation. Resp’t’s Rept., ECF No. 20.

On July 13, 2022, Petitioner filed an expert report from Salvatore Napoli, M.D. Pet’r’s Ex.

9, ECF No. 26. On October 24, 2022, Respondent filed an expert report from Peter Donofrio, M.D.

Resp’t’s Ex. A, ECF No. 28. On February 3, 2023, Petitioner filed a supplemental report from Dr.

Napoli. Pet’r’s Ex. 23, ECF No. 34. On April 19, 2023, Respondent filed a supplemental report

from Dr. Donofrio. Resp’t’s Ex. C, ECF No. 33.

The parties agreed to resolve entitlement with a ruling on the record. ECF No. 38. On April

12, 2024, Petitioner filed a motion for a ruling on the record. Pet’r’s Mot. In her motion, and for

the first time, Petitioner alleged an alternative significant aggravation claim for her GBS.7 Id. at 2.

4

CIDP is a “slowly progressive, autoimmune type of demyelinating polyneuropathy characterized by

progressive weakness and impaired sensory function in the limbs and enlargement of the peripheral

nerves, usually with elevated protein in the cerebrospinal fluid.” Chronic Inflammatory Demyelinating

Polyneuropathy, DORLAND’S. “It occurs most commonly in young adults, particularly males, and is

related to [GBS]. Presenting symptoms often include tingling or numbness of the digits, weakness of the

limbs, hyporeflexia or areflexia, fatigue, and abnormal sensations.” Id.

5

In Petitioner’s motion for a ruling on the record, after acknowledging that Respondent alleged Petitioner

fails to meet the Table requirements, Petitioner chose to move forward with only a causation-in-fact

claim. Pet’r’s Mot., at 1–2, 8. ECF No. 40. Petitioner’s motion for a ruling on the record “asks for a

finding that [Petitioner’s] GBS was caused by her vaccination. In the alternative, “should the special

master find that her symptoms began prior to her vaccination, that [Petitioner’s] GBS was significantly

aggravated by her [flu] vaccination.” Id. at 2.

6

While I have reviewed all of the information filed in this case, only those filings and records that are

most relevant to the decision will be discussed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d

1322, 1328 (Fed. Cir. 2016) (“We 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 & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“Finding

certain information not relevant does not lead to—and likely undermines—the conclusion that it was not

considered.”).

7

Petitioner did not file an amended petition.

2

Respondent filed a response on July 11, 2024, and Petitioner filed a reply on August 1, 2024.

Resp’t’s Response, ECF No. 43; Pet’r’s Reply, ECF No. 44. This matter is now ripe for

consideration.

II. Factual Background

A. Medical History

1. Pre-Vaccination and Vaccination Records

Petitioner was born March 28, 1964, with a past medical history that included hypertension,

post-menopausal treatment with hormone replacement therapy, sleep apnea, anxiety, and a

Hepatitis B infection in the 1970s. Pet’r’s Ex. 2 at 6, 584.

On April 26, 2018, Petitioner had a telehealth visit with Amena Syed, M.D., for sleep

apnea. Pet’r’s Ex. 2 at 26. She reported feeling fatigued during the day. Id. She had symptoms of

restless legs, with an onset in the “last few months.” Id. at 27. She was diagnosed with restless leg

syndrome, but no treatment was prescribed for that condition. Id. at 29. On August 7, 2018,

Petitioner underwent a home sleep study, which revealed mild obstructive sleep apnea. Id. at 34.

On November 21, 2018, the date of the subject vaccination, Petitioner saw Nurse

Practitioner (“NP”) Christina Farrell at her primary care provider’s (“PCP’s”) office for

palpitations and “neurological muscle weakness.” Pet’r’s Ex. 2 at 40. The history stated Petitioner

presented with concerns of palpitations and “muscle fatigue with feeling as though muscles giving

out that started [six to eight] weeks ago and ha[d] been increasing in frequency.” Id. at 41. It was

noted that Petitioner had a lot of stress and changes in her life at this time and was recently

diagnosed with sleep apnea, although she had not followed through with getting a mouth device

for treatment. Id. A review of systems revealed additional complaints of congestion, postnasal drip,

and a runny nose. Id. Petitioner also had “intermittent” weakness in both hands, both arms, and

both legs. Id. She denied any numbness. Id. On examination, she had an inflamed throat and mucus

membranes. Id. A neurological examination showed she had normal strength. Id. at 42. Her

bloodwork and electrocardiogram (“EKG”) were normal. Id. at 42–44. She was diagnosed with

allergic rhinitis, palpitations, and vitamin D deficiency. Id. at 40.

At that same November 21, 2018 visit, Petitioner received an intramuscular quadrivalent

flu vaccination. Pet’r’s Ex. 2 at 40, 45.

2. Post-Vaccination Records

Nine days later, on November 30, 2018, Petitioner saw Dr. Trixy Franke at her PCP office

for a follow-up for “progressive muscular weakness.” Pet’r’s Ex. 2 at 47. Petitioner reported

“gradual generalized symmetric weakness” for the past six months, which was “most noticeable

in past [two] months.” Id. She reported having a “weaker grip,” causing her to drop things easily

and could no longer turn the ignition in her car with one hand. Id. She also complained of difficulty

getting out of chairs, using the zipper on pants, shampooing, toileting, and working light switches.

Id. She was stumbling more frequently. Id. She reported paresthesia in her face and hands. Id. at

3

48. Examination revealed normal reflexes and strength. Id. at 49. Dr. Franke’s assessment was

“weakness” and “numbness and tingling of skin.” Id. She remarked that there was an “[u]ncertain

etiology” for Petitioner’s “progressive muscle weakness with associated paresthesia.” Id. She did

not suspect GBS. Id. (“Doubt [amyotrophic lateral sclerosis (“ALS”)] or GBS.”). She ordered

magnetic resonance imaging (“MRIs”) of the brain and cervical spine. Id.

On December 4, 2018, Petitioner called Dr. Franke to report that her weakness had

worsened since her last visit and was now severe in all four extremities. Pet’r’s Ex. 2 at 52–53. Dr.

Franke advised her to go to the emergency department (“ED”) if she had difficulty eating or

breathing. Id. at 53. Two days later, Petitioner called back, saying she felt “extremely weak” and

asked her husband to take her to the ED. Id. at 55.

On December 6, 2018, Petitioner presented to the Sunnyside Hospital (“Sunnyside”) ED

where she saw Dr. Eric Roth. Pet’r’s Ex. 2 at 59. Petitioner reported that she had been experiencing

“gradually worsening global weakness over [six] months,” which had seemingly become more

rapid in the past two weeks, more prominently in her arms. Id. Dr. Roth noted that Petitioner had

a flu shot two weeks prior. Id. Petitioner reported difficulty completing activities of daily living

(“ADLs”); for example, she stated she could not button her pants or brush her teeth. Id. at 60. She

stated that she had been working 70 to 80 hours per week, caring for her ailing parents, and

experiencing stress at her new job. Id. Dr. Roth noted Petitioner had decreased reflexes in both

arms. Id. His differential diagnosis included multiple sclerosis (“MS”), GBS, myasthenia gravis,

and central cord syndrome. Id. He noted: “It seems that rate of progression of her symptoms has

accelerated since she got a flu vaccination so GBS is a possibility.” Id. at 59. Petitioner was

admitted to the hospital. Id. at 73–75.

Early on December 7, 2018, Petitioner was examined by hospitalist Dr. Karen Piper. Pet’r’s

Ex. 2 at 64. Petitioner again reported that her symptoms began six months earlier and had rapidly

worsened in the past two weeks. Id. History also noted that Petitioner “[g]ot [f]lu shot [two] weeks

ago but was being seen at the time in Urgent Care for muscle fatigue for [six to eight] weeks prior

and palpitations.” Id. On examination, she was observed to use her elbows to push herself to a

sitting position. Id. at 68. Her hand grip was weak, with 3/5 strength bilaterally, and leg raise

strength was assessed at 5-/5. Id. Dr. Piper assessed progressive quadriplegia, worse in the upper

extremities than the lower extremities. Id. at 70. She recommended a neurohospitalist consultation.

Id.

The same day, Petitioner saw neurohospitalist Dr. Tajbibi Becker. Pet’r’s Ex. 2 at 82. For

the first time, she reported a history of a prior upper respiratory infection (“URI”). Id. According

to the history provided to Dr. Becker,

[Petitioner] began feeling mild generalized nonspecific weakness about [six]

months ago, had some stressors, recently started a new job. She and her husband

travel[led] to the East Coast in early November, they did travel outdoors [though]

they do not remember any tick bites but are concerned about that. About [three]

weeks ago she had a mild [URI]. She developed arm greater than leg weakness and

was seen around Thanksgiving for evaluation, at the time received a flu shot which

she felt accelerated her progressive weakness to the point that she began falling

4

down in the past few days. She denie[d] diarrheal illness. Arms [were] particularly

weak and recently there [were] some paresthesias but only in her hands. She note[d]

palpitations. She denie[d] constipation or bulbar symptoms. She [] had some mental

fogginess but [] attributed this to stress. She specifically remember[ed] having brisk

reflexes but [was] areflexic today.

Id. A lumbar puncture revealed an elevated protein level and white blood count (“WBC”), as well

as albuminocytologic dissociation. Id. at 69, 74. A workup assessing potential infectious causes

was negative. Id. at 74. Dr. Becker’s differential diagnosis included GBS. Id. at 82. The plan was

to start intravenous immunoglobulin (“IVIG”) treatment. Id.

Petitioner was discharged from the hospital on December 10, 2018. Pet’r’s Ex. 2 at 73. The

discharge summary noted that Petitioner reported “intermittent subacute numbness and functional

difficulty related to grip strength” over the preceding six months. Id. at 74. Her rapidly progressive

weakness of the extremities had developed “over the antecedent [three] weeks (and possibly [two]

months prior).” Id. “She described an antecedent URI but no other recent illnesses. She had

received a flu vaccine [two] weeks prior to admission.” Id. Her MRIs were not suggestive of a

demyelinating disease. Id. A three-day course of IVIG had “markedly” improved her symptoms.

Id. Her diagnosis at discharge was acute inflammatory demyelinating polyneuropathy

(“AIDP”)/GBS. Id. at 73–74. The plan was to discharge Petitioner back to her PCP and outpatient

rehab therapies. Id. at 74. She was instructed to seek further imaging/studies and a neurology

referral “if symptoms suggestive of [a] chronic/relapsing process occur[red].” Id. It was anticipated

Petitioner would “return to prior level of function.” Id. at 73.

On December 13, 2018, Petitioner began outpatient physical therapy. Pet’r’s Ex. 2 at 127.

Petitioner told the therapist that her weakness began about two months before her hospitalization.

Id. She reported that she then had a flu shot “and [the] weakness got worse.” Id.

On January 9, 2019, Petitioner reported to her physical therapist that she was “having some

decrease in her function over the last few days.” Pet’r’s Ex. 2 at 140. The next day, she presented

to the Sunnyside ED complaining of progressively worsening weakness over the past four days.

Id. at 149. She reported that she had a head cold after her discharge from the hospital in December.

Id. Dr. Julia Bullick wrote, “[r]ecurrence of symptoms of [GBS], also consider[ed] natural course

of disease though [Petitioner’s] symptoms seem[ed] markedly worsened compared to two weeks

ago. Less likely CIDP given acute nature of course.” Id. at 150. Petitioner was again admitted and

given two further IVIG treatments. Id. at 162. Her diagnosis remained GBS. Id. at 161. She was

discharged on January 12, 2019. Id.

On January 22, 2019, Petitioner saw neurologist Benjamin Koo. Pet’r’s Ex. 2 at 198.

Petitioner reported that her symptoms began “around Thanksgiving” and “progressed quickly after

the flu vaccine.” Id. Dr. Koo conducted an electromyography/nerve conduction study

(“EMG/NCS”), which revealed “electrodiagnostic evidence for a subacute, demyelinating

sensory-motor polyneuropathy with sparing of the sural sensory response characteristic of [GBS].”

Id. at 202.

5

Petitioner again presented to the Sunnyside ED on February 3, 2019, for progressively

“increasing weakness” over the past week. Pet’r’s Ex. 2 at 217. History noted Petitioner had a

“history of admission for [GBS] 12/6/[20]19 after a flu shot with recurrence on 1/10/2019.” Id. at

217; id. at 223 (GBS “seems to be recurrently relapsing – [December 2018, January 2019,] and

now [February 2019].”). Dr. Jason Miller admitted her for further IVIG treatment, and she was

given two doses of IVIG as an inpatient. Id. at 219. She was discharged on February 6, 2019, with

a diagnosis of “generalized weakness” and “[p]ossible exacerbation of [GBS].” Id. at 225. Dr. Koo

commented that it was “[u]nclear whether this [was] a true exacerbation/CIDP or subjective

malaise.” Id. The plan was to continue periodic IVIG treatments on an outpatient basis. Id.

On February 21, 2019, Dr. Koo performed a repeat EMG/NCS. Pet’r’s Ex. 2 at 275. He

concluded that there was “electrodiagnostic evidence for a primary demyelinating polyneuropathy

as can be seen in CIDP. Infusion center was called to arrange IVIG 2 gm/kg every [three] weeks.”

Id.

Petitioner continued with biweekly IVIG treatments throughout February and March 2019.

See Pet’r’s Ex. 2 at 326. On March 27, 2019, she had a follow-up appointment with Dr. Koo. Id.

at 325. For the first time, her diagnosis was CIDP rather than GBS. Id. Petitioner reported that the

IVIG treatment effects were wearing off “within less than a week” and that she was noticing

progression of weakness. Id. at 326. An examination revealed diminished reflexes and weakness

in all four limbs. Id. at 327–28. Dr. Koo’s plan was to increase the weekly IVIG dose, and if that

failed to stabilize her symptoms, to start long-term steroids and/or plasma exchange therapy. Id. at

325. He also planned to perform additional lab tests. Id. On April 5, 2019, rheumatologist Brian

Greenberg consulted on Petitioner’s case due to “abnormal labs” suggesting Sjogren’s disorder.

Id. at 358. He conducted a workup, which did not identify any other diagnoses. See id. at 457.

After Petitioner suffered several blood clots from the IVIG infusions, Dr. Koo decided to

start her on a trial of rituximab on June 17, 2019, while temporarily continuing the IVIG with the

addition of warfarin to prevent clots. Pet’r’s Ex. 2 at 499, 540. She was advised to take a pneumonia

vaccination prior to beginning the rituximab treatments, but she declined to do so “based on [her]

[f]lu vaccine reaction experience in November 2018.” Id. at 521.

On June 28, 2019, Petitioner sought a second opinion from neurologist S. Pius Wei. Pet’r’s

Ex. 5 at 9. She stated that her symptoms began in mid-November including weakness, fatigued,

and feeling “run-down.” Id. at 10. She received a flu shot during the ED evaluation and over “[t]he

next few days, started to feel worse and worse.” Id. On examination, Dr. Wei observed decreased

reflexes but normal strength. Id. at 11. Dr. Wei’s assessment was CIDP. Id. at 9. He noted her CSF

findings were compatible with AIDP/CIDP. Id. Dr. Wei agreed with Dr. Koo’s assessment and

plan, including “escalation to Rituximab if needed rather than plasmapheresis, doubtful that

plasmapheresis would be less thrombotic than IVIG.” Id. at 9.

Petitioner saw Dr. Koo for a follow-up appointment on September 4, 2019. Pet’r’s Ex. 2 at

709. Her diagnosis remained CIDP. Id. Because Petitioner had suffered recurrent thrombotic

episodes while on IVIG even with anticoagulant treatment, the IVIG had been discontinued. Id.

Since then, her weakness had worsened. Id. at 710. Treatment with prednisone had not provided

any benefit. Id. at 709. Although Petitioner had been given one rituximab treatment, “the efficacy

6

[would] not be known for a few months.” Id. “To stabilize her symptoms,” Dr. Koo’s plan was for

Petitioner to start plasmapheresis while waiting for the rituximab to work. Id.

On September 7, 2019, Petitioner presented to the Sunnyside ED after she experienced

worsening weakness to the point where she was “completely unable to walk with her walker.”

Pet’r’s Ex. 2 at 746. She could not use her arms to text or use her iPad. Id. Petitioner was admitted

for plasmapheresis with an assessment of CIDP. Id. at 758. On September 19, 2019, she was

discharged with a diagnosis of CIDP and sent to a rehabilitation facility to continue plasmapheresis

and rehabilitative therapies. Id. at 759. On September 27, 2019, Petitioner was discharged from

the rehabilitation facility. Id. at 1021. She continued on plasmapheresis on a twice-weekly basis,

along with prednisone treatment. Id. at 1114.

As of June 2020, Petitioner continued with a regimen of plasmapheresis. Pet’r’s Ex. 2 at

1424. On September 4, 2020, Dr. Koo reduced the frequency of plasmapheresis from twice to once

weekly. Pet’r’s Ex. 7 at 202–03. At an office visit on August 2, 2021, Dr. Koo noted Petitioner’s

condition was stable. Pet’r’s Ex. 8 at 145.

B. Petitioner’s Affidavit

In her affidavit filed on December 7, 2020, Petitioner explained that prior to the flu vaccine

she received on November 21, 2018, she was “in good health and suffering from no medical

conditions relevant to [her] petition other than general malaise.” Pet’r’s Ex. 3 at ¶ 3. On November

27, 2018, she “began experiencing limb weakness and loss of dexterity.” Id. at ¶ 4.

She recalled consulting with her PCP on November 30, December 5, and December 6,

2018. Pet’r’s Ex. 3 at ¶ 5. And on December 6, 2018, January 10, 2019, and February 3, 2019, she

was hospitalized. Id. at ¶ 6. She averred she was formally diagnosed with GBS on December 6,

2018, after a lumbar puncture. Id. On January 22, 2019, Petitioner underwent an EMG “and the

results indicated [CIDP]”. Id. at ¶ 7.

As of the date of this affidavit, Petitioner continued to suffer from the effects of her CIDP.

Pet’r’s Ex. 3 at ¶ 10. She is unable to fully function in daily activities. Id. at ¶ 11. Petitioner believed

the flu vaccine on November 21, 2018, “caused [her] GBS and CIDP.” Id. at ¶ 12.

III. Experts

A. Expert Qualifications

1. Petitioner’s Expert, Dr. Salvatore Napoli, M.D.

Petitioner did not file Dr. Napoli’s curriculum vitae. However, Dr. Napoli did list his

qualifications in his first expert report. Dr. Napoli is a board-certified neurologist who has

practiced medicine for the last 10 years. Pet’r’s Ex. 9 at 1. He received his M.D. from Albany

Medical College and subsequently completed a neurology residency at Albany Medical Center

Hospital and a clinical neuroimmunology fellowship at the Partners Harvard Multiple Sclerosis

Center at Brigham and Women’s Hospital. Id. at 2–3. In the last five years, he has seen and treated

7

approximately 10 to 40 patients with CIDP, GBS, “and other autoimmune peripheral nerve

disorders.” Id. at 2. Dr. Napoli has published articles focused on the neuroimmunology component

of central nervous system (“CNS”) disorders. Id.

2. Respondent’s Expert, Dr. Peter Donofrio, M.D.

Dr. Donofrio is a board-certified neurologist. Resp’t’s Ex. A at 1. He received his M.D.

from the Ohio State University School of Medicine and subsequently completed an internal

medicine residency, a neurology residency, and a neuromuscular fellowship. Resp’t’s Ex. B at 1–

2. He was a practicing physician for 47 years before retiring. Resp’t’s Ex. A at 1. During that time,

he evaluated and treated patients with GBS, CIDP, “and the related condition of Miller Fisher

Syndrome.”8 Id. Dr. Donofrio is a Professor Emeritus of Neurology at Vanderbilt University. Id.;

Resp’t’s Ex. B at 2. Currently, he is the Vice President of the Board of Directors of the GBS/CIDP

Foundation. Resp’t’s Ex. A at 1. Dr. Donofrio has authored or co-authored numerous publications.

Resp’t’s Ex. B at 15–34.

B. Expert Reports

1. Dr. Napoli’s First Report

In his first expert report, Dr. Napoli referred to Petitioner’s diagnosis as GBS and CIDP.

See Pet’r’s Ex. 9 at 5–6. He opined Petitioner’s “[flu] vaccine triggered [Petitioner’s] symptoms

and development of [GBS] and CIDP.” Id. at 6. Dr. Napoli explained vaccines are meant to

stimulate an immune response. Id. at 4. “If the antigen present on the vaccine shares any

homologies with host antigen, then immune response will be directed at both the injected antigens

and host antigen leading to an autoimmune response.” Id. He stated this is called molecular

mimicry and “is a well-known response in immunology.” Id. For support of this contention, he

generally cited articles on autoimmunity. Id. (citing Pet’r’s Ex. 11;9 Pet’r’s Ex. 13;10 Pet’r’s Ex.

14;11 Pet’r’s Ex. 15).12

Dr. Napoli then cited literature addressing vaccination and GBS. Schonberger et al.13

reported an increased risk of GBS following the A/New Jersey flu vaccination within a five-week

8

Miller Fisher Syndrome is a variant of GBS “characterized by areflexia, ataxia, and ophthalmoplegia.”

Fisher Syndrome, DORLAND’S.

9

Arnon Dov Cohen & Yehuda Shoenfeld, Vaccine-Induced Autoimmunity, 9 J. AUTOIMMUNITY 699

(1996).

10

S. Lee & M.C. Levin, Molecular Mimicry in Neurological Disease: What is the Evidence?, 65

CELLULAR & MOLECULAR LIFE SCIS. 1161 (2008).

11

Dimitrios Karussis & Panayiota Petrou, The Spectrum of Post-Vaccination Inflammatory CNS

Demyelinating Syndromes, 13 AUTOIMMUNITY REVS. 215 (2014).

12

Kai W. Wucherpfennig & Jack L. Strominger, Molecular Mimicry in T Cell-Mediated Autoimmunity:

Viral Peptides Activate Human T Cell Clones Specific for Myelin Basic Protein, 80 CELL 695 (1995).

13

Lawrence B. Schonberger et al., Guillain-Barre Syndrome Following Vaccination in the National

Influenza Immunization Program, United States, 1976–1977, 110 AM. J. EPIDEMIOLOGY 105 (1979).

8

period post vaccination. Pet’r’s Ex. 16 at 1. Langmuir et al.14 reported an increased risk for GBS

within 42 days (primarily within the second and third weeks) of the 1976 swine flu vaccination.

Pet’r’s Ex. 17 at 1. Haber et al.15 reviewed “evidence for a possible causal association between

vaccination and GBS” including case reports. Pet’r’s Ex. 18 at 2. The authors discussed case

reports that reached “inconclusive results on the association between [flu] vaccine and GBS,” and

found “with rare exceptions, causal associations between vaccines and GBS have not been

substantiated.” Id. at 5, 11. Dr. Napoli also cited case reports of GBS following the pneumococcal

vaccine. Pet’r’s Ex. 9 at 4–5 (citing Pet’r’s Ex. 19;16 Pet’r’s Ex. 20;17 Pet’r’s Ex. 21).18

In Dr. Napoli’s opinion, “there was a logical sequence of cause and effect between the

vaccine and [Petitioner’s] GBS.” Pet’r’s Ex 9. at 5. He explained that Petitioner received the flu

vaccination on November 21, 2018, and within nine days, “experienced symptoms of limb

weakness and loss of dexterity.” Id. “Within two weeks, she developed worsening limb weakness

and decrease in mobility” requiring hospitalization with IVIG treatment. Id. Relying on

Schonberger et al. and Langmuir et al., Dr. Napoli opined “[t]his is an appropriate timeline for

neurologic injury secondary to vaccine as it falls within the realm of a [five- to six-]week period

following vaccination.” Id. (citing Pet’r’s Exs. 16–17). He concluded, “the onset of [Petitioner’s]

symptoms began within one to two weeks of her receipt of the vaccine which is a medically

accepted time frame that falls within the realm of causation.” Id.

2. Dr. Donofrio’s First Report

Dr. Donofrio began by commenting that although Dr. Napoli used GBS and CIDP

interchangeably, GBS and CIDP “are two different illnesses with different evolutions,

manifestations, disease behavior, and response to treatment.” Resp’t’s Ex. A at 6.

GBS is a monophasic illness. Resp’t’s Ex. A at 6 (citing Resp’t’s Ex. A, Tab 1;19 Resp’t’s

Ex. A, Tab 2).20 “Patients with GBS do not typically have a recurrence and would not be expected

to have multiple exacerbations months to years after the initial event.” Id. at 7. Unlike GBS, CIDP

is not a monophasic illness. Id. Dr. Donofrio opined that “CIDP is not the long term consequence

of GBS. CIDP is a separate illness which shares some clinical features . . . with GBS.” Id. He

believed it to be a misconception to refer to CIDP as the chronic form of GBS. Id. “GBS and CIDP

are separate diseases and GBS does not evolve into CIDP.” Id. at 8. He stated CIDP is a “chronic

polyradiculoneuropathy that can manifest as a chronic progressive illness.” Id. at 7 (citing Resp’t’s

14

Alexander D. Langmuir et al., An Epidemiologic and Clinical Evaluation of Guillain-Barré Syndrome

Reported in Association with the Administration of Swine Influenza Vaccines, 119 AM. J. EPIDEMIOLOGY

841 (1984).

15

Penina Haber et al., Vaccines and Guillain-Barré Syndrome, 32 DRUG SAFETY 309 (2009).

16

H. E. Khatib et al., Case Report: Guillain-Barré Syndrome With Pneumococcus – A New Association in

Pediatrics, 11 IDCASES 36 (2017).

17

Nidhi Ravishankar, Guillain-Barre Syndrome Following PCV Vaccine, 2 CLINICS IN SURGERY 1413

(2017).

18

Hung Fu Tseng et al., Pneumococcal Conjugate Vaccine Safety in Elderly Adults, 5 OPEN FORUM

INFECTIOUS DISEASES 1 (2018).

19

Arthur K. Asbury & David R. Cornblath, Assessment of Current Diagnostic Criteria for Guillain-Barré

Syndrome, 27 ANNALS NEUROLOGY s21 (1990).

20

Hugh J. Willison et al., Guillain-Barré Syndrome, 388 LANCET 717 (2016).

9

Ex. A, Tab 3;21 Resp’t’s Ex. A, Tab 4;22 Resp’t’s Ex. A, Tab 5).23 Citing Ruts et al.,24 he explained

that 15% of cases of CIDP have an acute onset. Id. (citing Resp’t’s Ex. A, Tab 6). Consequently,

the initial diagnosis is often GBS and is later changed to CIDP. Id. “If CIDP presents acutely, it

may appear to resemble GBS, but its subsequent behavior as a disease will be CIDP.” Id. at 8.

Dr. Donofrio filed studies that address the relationship between GBS and CIDP. In Willison

et al., the authors noted that in patients that are initially diagnosed with GBS based on a rapidly

progressive course but then “subsequently have further progression exceeding [four] weeks, CIDP

should be considered instead of GBS.” Resp’t’s Ex. A, Tab 2 at 8. These cases are indicative of

the “5% of patients initially diagnosed with [GBS that] were eventually found to have acute onset

[CIDP].” Id. This consideration is especially prudent, according to the authors in cases wherein

patients “have three or more periods with clinical deterioration, or when there is a new

deterioration after [eight] weeks from onset of weakness.” Id.

The Ruts et al. study specifically aimed “to provide criteria that can help to distinguish

between GBS-[treatment related fluctuations (“TRFs”)] and [acute (“A”)-CIDP] in the early phase

of disease.” Resp’t’s Ex. A, Tab 6 at 1. Acknowledging the difficulty in differentiation because

they share “many symptoms and signs in the acute phase of disease,” the authors identified the

time to reach nadir of symptoms as the main factor clinicians consider. Id. They continued that the

timeframe for GBS is within four weeks and more than two months for CIDP. Id. However, they

cautioned that a significant number of patients, eight to 16%, do not fit neatly within one

presentation. Id. at 2. Indeed, they noted it may be very difficult to distinguish between a GBS-

TRF patient’s secondary deterioration and a second episode of weakness in an A-CIDP patient. Id.

These patients would need a repeated IVIG course or “a long-term maintenance treatment with

steroids, IVIG, or plasma exchange with or without immunosuppressive agents.” Id. The authors

compared 16 GBS-TRF patients to eight A-CIDP patients in a prospective longitudinal study over

the course of one year. Id. Within the study population, “5% of the patients initially diagnosed

with GBS were revealed to have A-CIDP.” Id. at 5. All A-CIDP patients had nadir within four

weeks; “however, active disease exceeded [eight] weeks.” Id. Conversely, none of the GBS-TRF

group “deteriorated after eight weeks,” or had more than two TRFs. Id. Additionally, “[t]he median

time to reach nadir, first exacerbation, and second exacerbation was significantly longer in the A-

CIDP group compared to the GBS-TRF group.” Id. Some A-CIPD patients were able “to walk

independently at nadir of the different deteriorations,” compared to none of the GBS-TRF patients.

Id. Also, some GBS-TRF patients “needed artificial ventilation at nadir of the different

deteriorations, compared to none of the A-CIDP patients.” Id. In summary, the authors opined:

21

Peter James Dyck et al., Chronic Inflammatory Polyradiculoneuropathy, 50 MAYO CLINIC

PROCEEDINGS 621 (1975).

22

Joint Task Force of the EFNS and the PNS, European Federation of Neurological Societies/Peripheral

Nerve Society Guideline on Management of Chronic Inflammatory Demyelinating

Polyradiculoneuropathy: Report of a Joint Task Force of the European Federation of Neurological

Societies and the Peripheral Nerve Society- First Revision, 15 J. PERIPHERAL NERVOUS SYS. 1 (2010).

23

Marinos C. Dalakas, Advances in the Diagnosis, Pathogenesis and Treatment of CIDP, 7 NATURE

REVS. NEUROLOGY 507 (2011).

24

L. Ruts et al., Distinguishing Acute-Onset CIDP From Fluctuating Guillain-Barré Syndrome, 74

NEUROLOGY 1680 (2010).

10

Patients with A-CIDP generally are less severely disabled compared to patients

with GBS-TRF. Patients remaining able to walk independently at nadir of different

deteriorations, having no cranial dysfunction, and showing electrophysiologic

features likely to be compatible with CIDP are more likely to have A-CIDP.

Id. at 6; see also Resp’t’s Ex. A, Tab 4 at 2 (In patients with prominent sensory symptoms, acute-

onset CIDP is likely in a patient initially diagnosed with GBS if deterioration continues for more

than two months from onset or if more than three treatment-related fluctuations occur.).

The Dalakas paper described CIDP in practical terms as “the chronic counterpart of [GBS]

owing to various electrophysiological, histological and immune similarities. CIDP differs from

GBS, however, by its time course, mode of evolution, prognosis and responsiveness to steroids.”

Resp’t’s Ex. A, Tab 5 at 1. CIDP is chronic, but the author described it as “often monophasic with

stepwise progression; . . . [and] relapsing with spontaneous remissions, necessitating periodic

evaluation of the usefulness of continued immunotherapy.” Id. at 2. The article further discussed

differences between GBS and CIDP. Id. Most notably, that “CIDP symptoms do not usually reach

[nadir] until at least [two] months from disease onset; by contrast, GBS evolves over less than

[four] weeks.” Id. The author noted however, some patients that present with “subacute onset and

a monophasic course that falls between the time frame of the two diseases.” Id. Still others

“experience a more acute onset and peak symptoms within [six to eight] weeks of onset,

resembling GBS.” Id.

Dr. Donofrio believed “CIDP is the best explanation for Petitioner’s illness as she

experienced the initial bout of weakness and [four] relapses on January 10, 2019, February 3, 2019,

February 20, 2019, and September 7, 2019.” Resp’t’s Ex. A at 7. CIDP was listed as the diagnosis

as early as February 2019. Id. (citing Pet’r’s Ex. 2 at 225). He noted that the terms GBS and CIDP

were used “imprecisely” in the medical records but that “the forms of treatment prescribed are

clearly those used in CIDP rather than GBS.” Id. at 9. Specifically, Petitioner’s treatment with

IVIG, subcutaneous immunoglobulin, plasma exchange, corticosteroids, and rituximab are

supportive of a CIDP diagnosis over GBS. Id. at 7. For further support of his opinion regarding

diagnosis, Dr. Donofrio commented on Petitioner’s complaints of malaise and fatigue. Id. He cited

Boukhris et al.25 for the position that fatigue can be a presenting symptom of CIDP. Id. (citing

Resp’t’s Ex. C, Tab 3). Given, Petitioner’s presentation to her PCP on November 21, 2018 (the

day of her flu vaccination), Dr. Donofrio opined her CIDP began “well before” vaccination since

she complained on that date of neurologic muscle weakness for the past six to eight weeks and had

generalized malaise dating back to April 2018. Id. (citing Pet’r’s Ex. 2 at 26, 40, 47). Thus, relying

on medical records, he opined the date of onset of her CIDP was in April 2018. Id.

25

S. Boukhris et al., Pain as the Presenting Symptom of Chronic Inflammatory Demyelinating

Polyradiculoneuropathy (CIDP), 254 J. NEUROLOGICAL SCIS. 33 (2007). Pursuant to his references, Dr.

Donofrio intended to cite S. Boukhris et al., Fatigue as the Main Presenting Symptom of CIDP: a Study of

11 Cases, 10 J. PERIPHERAL NERVOUS SYSTEM 329 (2005). However, that article was not filed, the 2007

Boukhris et al. article was. Boukhris et al. 2007 found that pain was the most common presenting

symptom of CIDP but noted two cases with fatigue as a presenting symptom. Resp’t’s Ex. C, Tab 3 at 1.

Boukhris et al. 2007 cited the Boukhris et al. 2005 article.

11

Further, Dr. Donofrio believed CIDP is the correct diagnosis because 16-32% of patients

have an antecedent infection preceding onset. Resp’t’s Ex. A at 7 (citing Resp’t’s Ex. A, Tab 12).26

While he opined the onset of her CIDP was April 2018, he asserted her URI around November 21,

2018, exacerbated her condition. Id. He believed the medical records documented Petitioner had a

URI “close to the time of her flu vaccination” including a physical examination on November 21,

2018, finding “basal mucous edema, rhinorrhea, and erythema of the posterior oral pharynx.” Id.

at 7–8. “The features of an URI would corroborate with her admission of having a mild upper

respiratory tract infection about [three] weeks before admission, when seen by the neurologist on

December 8, 2018.” Id. at 8 (citing Pet’r’s Ex. 2 at 89). The discharge summary from “her

December 6 through 10, 2018 admission [] describe[d] an antecedent upper respiratory tract

infection.” Id. (citing Pet’r’s Ex. 2 at 73). Additionally, Dr. Donofrio noted that Petitioner had

“another URI that precipitated another exacerbation of CIDP” on January 18, 2019. Id. He

concluded that Petitioner’s CIDP, which started in April 2018, worsened after her URI. Id. at 7.

He opined, the “worsening of CIDP after a[] URI in November 2018 is a much more plausible

causal relationship than a vaccination for which there is very little supportive data in CIDP.” Id. at

8.

Dr. Donofrio did not think the medical or scientific literature “demonstrate[s] the

probability of a causal relationship between CIDP and prior vaccinations, including the flu

vaccination.” Resp’t’s Ex. A at 8. He referenced several case reports of CIDP developing after

vaccination but distinguished them from the present case, because they involved a different

vaccine, the patient also had lupus, and/or the two-day onset is “an interval so short that it precludes

attributing the onset of the illness to an immune response.” Id. (citing Resp’t’s Ex. A, Tab 7 (CIDP

arising in a patient with lupus after rubella vaccination);27 Resp’t’s Ex. A, Tab 8 (CIDP arising

two days after flu vaccination);28 Resp’t’s Ex. A, Tab 9 (same)).29 However, he focused on the

2012 IOM report in which the authors stated that “[n]o studies were identified in the literature for

the committee to evaluate the risk of [CIDP] after the administration of the [flu] vaccine,” and “the

committee assesse[d] the mechanistic evidence regarding an association between [flu] vaccine and

CIDP as weak based on two cases.” Id. (quoting Resp’t’s Ex. A, Tab 10 at 1).30 Dr. Donofrio

commented that the “report of a few patients developing CIDP after any vaccination does not prove

a cause and effect relationship as the CIDP may have occurred purely by chance.” Id. (citing

Resp’t’s Ex. A, Tab 10).

Dr. Donofrio took issue with the literature Dr. Napoli filed to support his position as “none

of them discuss CIDP.” Resp’t’s Ex. A at 8. He specifically pointed out that Haber et al. reported

26

Thomas H. Brannagan III, Current Diagnosis of CIDP: The Need for Biomarkers, 16 J. PERIPHERAL

NERVOUS SYS. 3 (2011).

27

P.G. Sanz et al., Chronic Inflammatory Demyelinating Polyradiculoneuropathy in a Patient with

Systemic Lupus Erythematosus and Good Outcome with Rituximab Treatment, RHEUMATOLOGY INT’L

(2011).

28

J.M. Brostoff et al., Post-Influenza Vaccine Chronic Inflammatory Demyelinating Polyneuropathy, 37

AGE AND AGEING 229 (2008).

29

Praful Kelkar, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) With Rapid Progression

After Influenza Vaccination: A Report of Three Cases, 8 J. CLINICAL NEUROMUSCULAR DISEASE 20

(2006).

30

Inst. of Med., Adverse Events Associated with Childhood Vaccines: Evidence Causality (Kathleen

Stratton et al. eds., 2012).

12

a “negative relationship between vaccinations and GBS.” Id. (emphasis omitted) (citing Pet’r’s

Ex. 18). Dr. Donofrio also pointed out that Dr. Napoli failed to mention Petitioner’s URI that

preceded her weakness and January 18, 2019 CIDP exacerbation, as well as her weakness and

malaise that started in April 2018. Id. at 8–9.

In sum, Dr. Donofrio opined that Petitioner’s correct diagnosis is CIDP, not GBS (or

AIDP). Resp’t’s Ex. A at 9. At the time Petitioner received her vaccination on November 21, 2018,

she also had a URI. Id. “The behavior of [P]etitioner’s illness is consistent with the initial

presentation of CIDP and four exacerbations.” Id. He believed her fatigue, dating back to April

2018, “could be explained by pre-existing CIDP.” Id. Thus, “[t]he presence of those symptoms as

a likely harbinger of CIDP makes moot the flu vaccination [as a cause] and any diagnosis of GBS.”

Id. “Because there is no evidence that CIDP can be caused by flu vaccination, it follows that the

[P]etitioner’s flu vaccination was not a more-likely-than-not cause of her CIDP or exacerbations

thereof, and her episodes of weakness did not occur in a medically acceptable timeframe to infer

vaccine causation.” Id.

3. Dr. Napoli’s Second Report

Dr. Napoli filed a supplemental report “strongly disagree[ing] with Dr. Donofrio’s

assessment.” Pet’r’s Ex. 23 at 1. First, as to diagnosis, Dr. Napoli wrote that while Petitioner was

in the “acute setting with acute symptoms, she was described as having [GBS] which was a

completely reasonable and appropriate hypothesis and diagnosis in that setting.” Id. He explained

that it was as Petitioner’s “symptoms evolved, with relapses and progression over a period of time,

that it was considered CIDP.” Id. He opined, “[t]he difference between the two diagnoses involves

timing and progression, which the specialists at the time would not have known about. However,

. . . the underlying pathology is the same: demyelinating neuropathy. If anything, the diagnosis of

CIDP bears out the seriousness of her condition.” Id.

Next, Dr. Napoli opined that the “timeline of onset of symptoms strongly suggest that the

vaccine was the true etiology” rather than a URI. Pet’r’s Ex. 23 at 1. He stated the vaccine “was

given within days of the onset of symptoms” and the “potential” URI was three weeks prior to

onset. Id. Therefore, the “onset of [Petitioner’s] neurologic symptoms fits the timeline of vaccine

administration more so than a possible [URI] that occurred [one] month prior.” Id.

Finally, he believed that “to suggest that symptoms of malaise and fatigue in April 2018

were the initial harbinger of onset of CIDP symptoms is extremely hypothetical.” Pet’r’s Ex. 23 at

1. Dr. Napoli did not find documentation, such as neurologic examination or electrodiagnostic

data, to support Dr. Donofrio’s conclusion. Id. Further, Dr. Napoli wrote that “symptoms of

malaise and weakness are common in the general population and can mean anything. There is no

specific data to suggest those symptoms were anything close to being CIDP.” Id.

4. Dr. Donofrio’s Second Report

Dr. Donofrio agreed with Dr. Napoli that “in the initial acute setting with acute symptoms,

it might have been appropriate to render the diagnosis [GBS].” Resp’t’s Ex. C at 1. “[B]ut the

eventual diagnosis was CIDP, and the initial presentation subsequently was categorized as the

13

acute form of CIDP. A patient cannot have both GBS and CIDP, as these are distinct conditions.”

Id. Thus, he maintained that the correct diagnosis for Petitioner is CIDP. Id. He added that “the

arguments for and against flu vaccine causation in GBS would not apply to CIDP.” Id. at 2.

Dr. Donofrio then pointed out that Dr. Napoli did not state his rationale for the opinion that

the timeline is more appropriate for a vaccine-related etiology than the URI. Resp’t’s Ex. C at 1.

He explained that “the neurologic literature does not bear out the relationship between flu

vaccination and GBS after the swine flu epidemic of 1976-77, much less a theoretical causal link

between flu vaccination and CIDP.” Id. As mentioned in his first report, there are “very few cases

of CIDP [] preceded by a flu vaccination,” whereas 16-32% of patients with CIDP have an

antecedent infection preceding onset. Id. “The timeline is better suited for a[ URI] to lead to CIDP

than the vaccine. This belief is supported by the medical literature as cited [in his reports] and the

lack of literature supporting a relationship to vaccination.” Id. Furthermore, Dr. Donofrio again

emphasized that Petitioner “complained of weakness on the day of the vaccination which would

eliminate any consideration of the vaccine causing the weakness.” Id.

Dr. Donofrio recognized that although Dr. Napoli pointed out “the absence of documented

weakness, numbness, neurologic deficits, or electrodiagnostic data in [P]etitioner, [Dr. Napoli did]

not offer any alternative medical or neurologic explanation for the symptoms of malaise and

fatigue.” Resp’t’s Ex. C at 2. Dr. Donofrio believed that “symptoms of malaise and fatigue are

important and can be used as clues to the onset of an illness” and thus asserted that “these pre-

vaccination symptoms indicate [P]etitioner was developing CIDP.” Id. (citing Resp’t’s Ex. C, Tab

3). In his clinical experience, Dr. Donofrio finds

it is unlikely a patient would have one condition causing significant malaise and

fatigue/weakness in the weeks and months before the vaccination, and then develop

a totally different condition causing similar symptoms after the vaccination. In the

practice of medicine, one illness that can explain all or most of a patient’s symptoms

and signs is most likely to be correct (the concept of Occam’s Razor).

Id.

Ultimately, Dr. Donofrio maintained that Petitioner “developed CIDP months before the

vaccination, or the URI caused her to develop CIDP around the time of vaccination.” Resp’t’s Ex.

C at 2.

IV. Applicable Legal Standards

A. Standard of Adjudication—Burden of Proof

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 & Hum. 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).

14

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 & Hum. Servs., 592 F.3d 1315,

1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health

& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).

B. Standard of Adjudication—Factual Issues

A petitioner must prove, by a preponderance of the evidence, the factual circumstances

surrounding her claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh

the evidence presented, which may include contemporaneous medical records and testimony. See

Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special

master must decide what weight to give evidence including oral testimony and contemporaneous

medical records).

In Program cases, contemporaneous medical records and the opinions of treating

physicians are favored. Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325, 1326

(Fed. Cir. 2006) (citing Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1280 (Fed. Cir.

2005)). Indeed, when reviewing the record, a special master must consider the opinions of treating

physicians. Capizzano, 440 F.3d at 1326. This is because “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.’” Id. In addition, “[m]edical records, in general, warrant

consideration as trustworthy evidence. The records contain information supplied to or by health

professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment

hanging in the balance, accuracy has an extra premium. These records are also generally

contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d

1525, 1528 (Fed. Cir. 1993).

While a special master must consider these opinions and records, they are not “binding on

the special master or court.” § 13(b)(1). Rather, when “evaluating the weight to be afforded to any

such . . . [evidence], the special master . . . shall consider the entire record . . . .” Id. There is no

presumption that medical records are accurate and complete as to all the patient’s physical

conditions. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021) (finding

that “[b]ecause a reasonable fact finder could conclude that [Petitioner’s] testimony [wa]s not

inconsistent with her medical records . . . it was not arbitrary and capricious for the special master

to credit [Petitioner’s] testimony” over her medical records).

Where there are inconsistencies, special masters are within their discretion to award

contemporaneous medical records greater weight than later conflicting testimony. See Cucuras,

993 F.2d at 1528 (holding that the special master’s reliance on contemporaneous medical records

over conflicting oral testimony given after the fact was not arbitrary or capricious); see also Burns,

3 F.3d at 417 (holding that the decision of whether to accord greater weight to contemporaneous

medical records or later given testimony is “uniquely within the purview of the special master”).

Indeed, the Court of Federal Claims has outlined four potential explanations for inconsistencies

between contemporaneously created medical records and later testimony: (1) a person’s failure to

recount to the medical professional everything that happened during the relevant time period; (2)

15

the medical professional’s failure to document everything reported to her or him; (3) a person’s

faulty recollection of the events when presenting testimony; or (4) a person’s purposeful

recounting of symptoms that did not exist. LaLonde v. Sec’y of Health & Hum. Servs., 110 Fed.

Cl. 184, 203–04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014).

Despite the weight afforded to medical records, special masters are not bound rigidly by

those records in determining onset of a petitioner’s symptoms. Valenzuela v. Sec’y of Health &

Hum. Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see

also Eng v. Sec’y of Health & Hum. Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl. Spec.

Mstr. Feb. 18, 1994) (“[Section 13(b)(2)] must be construed so as to give effect also to § 13(b)(1)

which directs the special master or court to consider the medical records (reports, diagnosis,

conclusions, medical judgment, test reports, etc.), but does not require the special master or court

to be bound by them.” (emphasis omitted)).

C. Standards for Adjudication—Causation

To receive compensation through 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 she received, or (2) that she suffered an injury that was actually caused by a

vaccination. See §§ 11(c)(1), 13(a)(1)(A); Capizzano, 440 F.3d at 1319–20. While the petition

initially asserted a Table claim and causation-in-fact claim, Petitioner’s motion for a ruling on the

record narrowed her assertions to only causation-in-fact. Pet’r’s Mot. at 1–2. Therefore, Petitioner

must prove a vaccine she received caused her injury. To do so, Petitioner must establish, by

preponderant evidence: “(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.”

Althen, 418 F.3d at 1278.

A petitioner must offer a scientific or medical theory that answers in the affirmative the

question: “can the vaccine[] at issue cause the type of injury alleged?” See Pafford v. Sec’y of

Health & Hum. Servs., No. 01-0165V, 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16,

2004), mot. for rev. denied, 64 Fed. Cl. 19 (2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006). To satisfy

this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific

explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such

a theory must only be “legally probable, not medically or scientifically certain.” Id. at 548–49. A

petitioner is not required to identify “specific biological mechanisms” to establish causation, nor

are they required to present “epidemiologic studies, rechallenge[] the presence of pathological

markers or genetic disposition, or general acceptance in the scientific or medical communities.”

Capizzano, 440 F.3d at 1325 (quoting Althen, 418 F.3d at 1280). Scientific and “objective

confirmation” of the medical theory with additional medical documentation is unnecessary. Althen,

418 F.3d at 1278–81; see also Moberly, 592 F.3d at 1322. Petitioner need not make a specific type

of evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological

markers or genetic predisposition, or general acceptance in the scientific or medical communities

to establish a logical sequence of cause and effect.” Capizzano, 440 F.3d at 1325. However,

Petitioner cannot establish entitlement to compensation based solely on his assertions; rather, a

vaccine claim must be supported either by medical records or by the opinion of a medical doctor.

16

§ 13(a)(1). Furthermore, as the Federal Circuit has made clear, “simply identifying a ‘plausible’

theory of causation is insufficient for a petitioner to meet her burden of proof.” LaLonde v. Sec’y

of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (citing Moberly, 592 F.3d at 1322).

Testimony that merely expresses the possibility—not the probability—is insufficient, by itself, to

substantiate a claim that such an injury occurred. See Waterman v. Sec’y of Health & Hum. Servs.,

123 Fed. Cl. 564, 573–74 (2015) (denying Petitioner’s motion for review and noting that a possible

causal link was not sufficient to meet the preponderance standard). While certainty is by no means

required, a possible mechanism does not rise to the level of preponderance. Moberly, 592 F.3d at

1322; see also de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008).

Rather, “[a] petitioner must provide a reputable medical or scientific explanation that pertains

specifically to the petitioner’s case.” Moberly, 592 F.3d at 1322.

Next, a petitioner must prove that the vaccine actually did cause the alleged injury in a

particular case. See Pafford, 2004 WL 1717359, at *4; Althen, 418 F.3d at 1279. A petitioner does

not meet this obligation by showing only a temporal association between the vaccination and the

injury; instead, the petitioner “must explain how and why the injury occurred.” Pafford, 2004 WL

1717359, at *4 (emphasis in original). In particular, Petitioner must prove that the vaccine was

“not only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”

Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,

1352–53 (Fed. Cir. 1999)); see also Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352,

1355 (Fed. Cir. 2006). The received vaccine, however, need not be the predominant cause of the

injury. Shyface, 165 F.3d at 1351. The special master in Pafford noted petitioners “must prove []

both that her vaccinations were a substantial factor in causing the illness . . . and that the harm

would not have occurred in the absence of the vaccination.” 2004 WL 1717359, at *4 (citing

Shyface, 165 F.3d at 1352). A reputable medical or scientific explanation must support this logical

sequence of cause and effect. Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed Cir.

1993) (citation omitted).

Lastly, a petitioner must show that the timing of the injury fits with the causal theory. See

Althen, 418 F.3d at 1278. For example, if a petitioner’s theory involves a process that takes several

days to develop after vaccination, an injury that occurred within a day of vaccination would not be

temporally consistent with that theory. Conversely, if the theory is one that anticipates a rapid

development of a reaction post-vaccination, the development of the alleged injury weeks or months

post-vaccination would not be consistent with that theory. See de Bazan, 539 F.3d at 1352.

Causation-in-fact cannot be inferred from temporal proximity alone. See Grant v. Sec’y of Health

& Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992); Thibaudeau v. Sec’y of Health & Hum.

Servs., 24 Cl. Ct. 400, 403–04 (1991); see also Hasler v. United States, 718 F.2d 202, 205 (6th

Cir. 1983) (“[w]ithout more, [a] proximate temporal relationship will not support a finding of

causation”).

In determining whether Petitioner is entitled to compensation, the special master shall

consider all materials 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’ proffered experts and rule in

Petitioner’s favor when the evidence weighs in her favor. See Moberly, 592 F.3d at 1325–26

(“Finders of fact are entitled—indeed, expected—to make determinations as to the reliability of

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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). A petitioner who satisfies her 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). However, if a petitioner fails to establish a

prima facie case, the burden does not shift. Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d

1570, 1575 (Fed. Cir. 1993).

D. Standards for Adjudication—Alternative Causation

A petitioner who satisfies all three prongs of the Althen test (or all six prongs of the

Loving test) has established a prima facie showing of causation. Hammitt v. Sec’y of Health &

Hum. Servs., 98 Fed. Cl. 719, 726 (2011). Where a petitioner demonstrates by a preponderance

of the evidence that she suffered an injury caused by vaccination, the government must not

merely prove the existence of an alternative cause, but that such an alternative actually caused

the injury. Knudsen, 35 F.3d at 549. Additionally, a factor unrelated “may not include ‘any

idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness

or condition.’” § 13(a)(2); see also Doe, 601 F.3d 1349 (opining that an idiopathic diagnosis

cannot be a “factor unrelated,” as it is idiopathic).

“Regardless of whether the burden ever shifts to the respondent, the special master may

consider the evidence presented by the respondent in determining whether the petitioner has

established a prima facie case.” Flores v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 157, 162-

63 (2014); see also Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012)

(“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors unrelated’

defense, but also to whether a prima facie showing has been made that the vaccine was a substantial

factor in causing the injury in question.”); de Bazan, 539 F.3d at 1353 (“The government, like any

defendant, is permitted to offer evidence to demonstrate the inadequacy of the [P]etitioner’s

evidence on a requisite element of the [P]etitioner’s case-in-chief.”); Pafford, 451 F.3d at 1358–

59(“[T]he presence of multiple potential causative agents makes it difficult to attribute ‘but for’

causation to the vaccination. . . . [T]he Special Master properly introduced the presence of the

other unrelated contemporaneous events as just as likely to have been the triggering event as the

vaccinations.”).

IV. Discussion

A. Diagnosis

In cases where the diagnosis is contested, “special masters may find whether a

preponderance of evidence supports any proposed diagnosis before evaluating whether a vaccine

caused that illness.” Hibbard v. Sec’y of Health & Hum. Servs, No. 07–446V, 2011 WL 1766033,

at *6 (Fed. Cl. Spec. Mstr. April 12, 2011) (citing Broekelschen v. Sec’y of Health & Hum. Servs.,

618 F.3d 1339, 1345–46 (Fed. Cir. 2010)). In this case, diagnosis is in dispute, so it is appropriate

to address it first.

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Petitioner asserts that her diagnosis is GBS, “which has since evolved into its chronic

form,” CIDP. Pet’r’s Reply at 1. Respondent, through his expert, argues “GBS and CIDP are

distinct conditions, and it is a ‘misconception’ to characterize CIDP as the chronic form of GBS.”

Resp’t’s Response at 11 (quoting Resp’t’s Ex. A at 6–7).

Dr. Napoli’s opinions on GBS and CIDP are contradictory in that he acknowledged the

diseases are different but continued to refer to them as one. He stated the difference between the

two diseases is timing and progression and opined that Petitioner’s diagnosis of GBS was

“completely reasonable and appropriate” in that acute setting. Pet’r’s Ex. 23 at 1. However, as

Petitioner’s “symptoms evolved with relapses and progression over time, [] it was considered

CIDP.” Id. Thus, it seems Dr. Napoli acknowledged the change in diagnosis from GBS to CIDP.

While Dr. Donofrio asserted that CIDP is not the chronic form of GBS, the Dalakas paper

described CIDP in practical terms as “the chronic counterpart of [GBS].” Resp’t’s Ex. A, Tab 5 at

1. Importantly, the paper further described GBS and CIDP as distinct diseases and pointed out

differences between the two, including timing and progression. See id. at 2 (“CIDP symptoms do

not usually reach [nadir] until at least [two] months from disease onset; by contrast, GBS evolves

over less than [four] weeks.”). Further, the Ruts et al. article, in distinguishing GBS from CIDP,

noted that none of the GBS patients studied continued to deteriorate after eight weeks. Conversely

all of the A-CIDP patients studied had nadir within four weeks, despite active disease continuing

beyond eight weeks. And Willison et al. noted that in patients initially diagnosed with GBS based

on a rapidly progressive course, CIDP should be considered where there is “further progression

exceeding [four] weeks.” Resp’t’s Ex. A, Tab 2 at 8.

While the two diseases may overlap, the literature provides preponderant evidence that

they are distinct, and Dr. Napoli acknowledged differences between the two. In fact, the only

similarity Dr. Napoli made between GBS and CIDP was “the underlying pathology” as a

“demyelinating neuropathy.” Pet’r’s Ex. 23 at 1. He did not explain this any further or provide any

citations on this point.

While a neurological condition may initially present as GBS, the subsequent disease course

may ultimately reveal that CIDP is more applicable; thus, as is the case here, the proper diagnosis

is no longer GBS. The medical providers who examined and diagnosed Petitioner provided a

detailed record of such evolution of Petitioner’s condition. On December 6, 2018, Petitioner

presented to the ED reporting difficulties with ADLs and the rapid worsening of gradual weakness.

Petitioner was admitted to the hospital with a differential diagnosis of GBS. During her December

7, 2018 hospitalization, Dr. Becker evaluated Petitioner and maintained a differential diagnosis of

GBS, starting her on a three-day-course of IVIG that “markedly” improved her symptoms. Pet’r’s

Ex. 2 at 73. The hospital discharge summary included that Petitioner reported “intermittent

subacute numbness” over the preceding six months and that her rapidly progressive weakness of

the extremities had developed “over the antecedent [three] weeks (and possibly [two] months

prior).” Id. at 74. The discharge diagnosis was AIDP/GBS, but she was instructed to seek further

neurology evaluation “if symptoms suggestive of [a] chronic/relapsing process occur[red].” Id. at

74.

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On January 10, 2019, Petitioner returned to the ED with worsening weakness over the past

four days. Dr. Bullick wrote, “[r]ecurrence of symptoms of [GBS], also consider[ed] natural course

of disease though [Petitioner’s] symptoms seem[ed] markedly worsened compared to two weeks

ago. Less likely CIDP given acute nature of course.” Pet’r’s Ex. 2 at 150. Petitioner was again

admitted and given two further IVIG treatments. Id. at 162. Her diagnosis remained GBS, and a

January 22, 2019 EMG/NCS supported that assessment. Id. at 161.

Petitioner returned to the ED on February 3, 2019, for increasing weakness. History noted

Petitioner had a “history of admission for [GBS] 12/6/[20]19 after a flu shot with recurrence on

1/10/2019.” Pet’r’s Ex. 2 at 217, 223 (GBS “seems to be recurrently relapsing – [December 2018,

January 2019,] and now [February 2019].”). Dr. Miller admitted her for further IVIG treatment,

and she was given two doses of IVIG. Id. at 219. She was discharged with a diagnosis of

“generalized weakness” and “[p]ossible exacerbation of [GBS].” Id. at 225. Dr. Koo commented

that it was “[u]nclear” whether this was indicative of a GBS exacerbation, “CIDP[,] or subjective

malaise.” Id.

This was the first indication in the medical record that reflects the clinical presentation

transition from GBS to CIDP. A repeat EMG/NCS performed on February 21, 2019 showed

“primary demyelinating polyneuropathy as can be seen in CIDP.” Pet’r’s Ex. 2 at 275. A note from

Petitioner’s March 27, 2019 visit with neurologist Dr. Koo, listed Petitioner’s diagnosis as CIDP,

rather than GBS. On June 28, 2019, Petitioner sought a second opinion from neurologist Dr. Wei,

whose assessment was also CIDP. He specifically noted Petitioner’s CSF findings were compatible

with CIDP. On September 7, 2019, Petitioner returned to the ED for worsening weakness and the

inability to walk. The diagnosis at admission and discharge was CIDP. Indeed, the documented

progression of Petitioner’s disease course in the medical records and arrival of her treaters to the

ultimate diagnosis of CIDP after extensive treatment and continued testing (including the

EMG/NCS consistent with CIDP), is the most persuasive evidence that Petitioner suffered from

CIDP.

Both Drs. Napoli and Donofrio agreed that based on Petitioner’s initial presentation, GBS

was the correct diagnosis at that time. However, the medical records show Petitioner’s condition

worsened and had approximately four recurrences, also described as exacerbations, flares, or

relapses. Importantly, the physicians noted her condition was “recurrently relapsing.” Pet’r’s Ex.

2 at 223. This characterization, according to the filed literature, is contrary to the definition of

GBS. See Resp’t’s Ex. A, Tab 2 at 2 (GBS is a “monophasic disease course (<1 month) . . . usually

without relapse.”). Consistent with that literature, Dr. Donofrio opined that “[p]atients with GBS

do not typically have a recurrence and would not be expected to have multiple exacerbations

months to years after the initial event, as the [P]etitioner did.” Resp’t’s Ex. A at 7. Conversely, the

medical records accurately document a disease consistent with the description of CIDP. The

Dalakas paper described CIDP as chronic but “often monophasic with stepwise progression; . . .

[and] relapsing with spontaneous remissions, necessitating periodic evaluation of the usefulness

of continued immunotherapy.” Resp’t’s Ex. A, Tab 5 at 2. Dr. Napoli did not address the

inconsistencies between his asserted GBS diagnosis and Petitioner’s presentation in the context of

this literature.

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Dr. Donofrio offered medical literature that explained how and why CIDP is often initially

diagnosed as GBS and subsequently changed to CIDP. For example, Willison et al. warned that in

patients initially diagnosed with GBS based on a rapidly progressive course but then “subsequently

have further progression exceeding [four] weeks, CIDP should be considered instead of GBS.”

Resp’t’s Ex. A, Tab 2 at 8. This is consistent with Petitioner’s initial hospitalization, during which

the discharge diagnosis was AIDP/GBS, but Petitioner was instructed to seek further neurology

evaluation “if symptoms suggestive of chronic/relapsing process occur[red].” Pet’r’s Ex. 2 at 74.

Willison et al. noted that these types of cases are indicative of the “5% of patients initially

diagnosed with [GBS that] were eventually found to have acute onset [CIDP].” Resp’t’s Ex. A,

Tab 2 at 8. This consideration is especially prudent in cases wherein patients “have three or more

periods with clinical deterioration, or when there is a new deterioration after [eight] weeks from

onset of weakness.” Id. After the first hospitalization, Petitioner had further progression and three

subsequent hospitalizations over the span of nine months.

Dr. Donofrio also argued that Petitioner’s response to the IVIG courses was consistent with

CIDP. Petitioner had continuous success with IVIG that wore off within one week of treatment.

Dr. Napoli did not address Dr. Donofrio’s arguments about the successful IVIG treatment; he

merely stated his strong disagreement with Dr. Donofrio’s comments on diagnosis generally.

However, without explanation or supporting authority, his conflicting opinion is not as persuasive.

After consideration of all of the evidence, including but not limited to Petitioner’s medical

history, filed medical literature, and expert reports, I find that Petitioner has not presented

preponderant evidence that she has GBS. The record contains preponderant evidence that

Petitioner has CIDP.

B. Causation

1. Althen Prong One

From the outset, Petitioner only presented evidence of causation as it relates to GBS and

did not file any medical literature related to CIDP. Dr. Napoli also did not present any opinions on

causation as it relates specifically to CIDP. Because I found preponderant evidence that CIDP is

the relevant diagnosis, a causation theory that is presented solely in the context of GBS is not

applicable to CIDP without further explanation. It follows that Petitioner cannot prove causation

by a preponderance of the evidence.

I will note that Petitioner presented preponderant evidence of a sound and reliable medical

theory that could connect the flu vaccination to GBS pursuant to Althen prong one. But Petitioner

has not alleged that this causation theory is applicable to CIDP, and she has not alleged a CIDP

injury with a different causation theory given the differences between the conditions that have

been detailed in this Decision. Indeed, Petitioner has not presented preponderant evidence of a

causation theory for any chronic demyelinating disease. Therefore, Petitioner has failed to present

preponderant evidence that her causation theory for flu vaccine-caused GBS is applicable or

analogous to her CIDP diagnosis, and accordingly, does not meet her burden pursuant to Althen

prong one.

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2. Althen Prong Two

A successful argument pursuant to Althen prong two is heavily dependent on a reliable

causation theory. Petitioner’s inability to meet her burden demonstrating how the flu vaccine can

cause CIDP effectively precludes her from being able to show that her symptoms were actually

caused by the vaccine according to said theory. Moreover, Dr. Napoli did not analyze Petitioner’s

clinical presentation (even as GBS) in the context of his theory. This alone hinders any meaningful

discussion on prong two.

In considering the reliability of a petitioner’s evidence of a prima facie case, the special

master may consider alternative causes for a petitioner’s condition that are reasonably raised in the

record, even if the respondent does not pursue a formal alternative cause argument. Doe v. Sec’y

of Health & Hum. Servs., 601 F.3d 1349, 1358 (Fed. Cir. 2010). Thus, in weighing a petitioner’s

case-in-chief, a special master may consider evidence that the petitioner’s alleged injury could

have been caused by alternative causes. Id.

While Petitioner received the flu vaccine on November 21, 2018, she also had a URI on

November 21, 2018. In addition to the “neurological muscle weakness” complaints that day, she

also reported congestion, postnasal drip, and a runny nose. Pet’r’s Ex. 2 at 40–41. The discharge

summary from her December 2018 hospitalization also noted an antecedent URI. In fact,

Petitioner’s treaters do not definitively identify whether the cause of Petitioner’s CIDP is her URI

or flu vaccine. Dr. Donofrio asserted that Petitioner’s URI caused her CIDP or worsening of her

CIDP.31 He reasoned there are “very few cases of CIDP [] preceded by a flu vaccination,” whereas

16-32% of patients with CIDP have an antecedent infection preceding onset. Resp’t’s Ex. C at 1.

Dr. Donofrio also asserted that the timeline is better suited for URI causation, although he did not

provide specific literature supporting this assertion. In rebuttal, Dr. Napoli argued that the onset of

Petitioner’s neurologic symptoms fit the timeline of vaccine causation (within days) more so than

a URI causation (described as three weeks and one month). He also did not provide further

explanation for his contention. Ultimately, their unsupported conclusions are not preponderant

evidence of actual causation for either the URI or the flu vaccine in Petitioner’s case. Petitioner

did not provide preponderant evidence of a logical sequence of cause and effect between

Petitioner’s vaccination and her CIDP. Therefore, I find that Petitioner has failed to satisfy Althen

prong two.

3. Althen Prong Three

Petitioner asserts her “symptoms began just [six] days after vaccination, and she

experienced near-debilitating symptoms as early as [nine] days after vaccination.” Pet’r’s Mot. at

21. Dr. Napoli opined this is “an appropriate timeline for neurologic injury secondary to vaccine

as it falls within the realm of a [five- to six-]week period following vaccination.” Pet’r’s Ex. 9 at

5. Whereas Dr. Donofrio opined Petitioner’s CIDP began “well before” vaccination since she

complained of neurologic muscle weakness for the past six to eight weeks on November 21, 2018

31

Because I find below that there is preponderant evidence that Petitioner’s onset was pre vaccination,

and Petitioner failed to present a significant aggravation claim, I only discuss Dr. Donofrio’s opinions

regarding the URI causing Petitioner’s CIDP, not worsening her CIDP.

22

(the day of her flu vaccination) and had generalized malaise dating back to April 2018. Resp’t’s

Ex. A at 7.

The medical records indicate Petitioner had symptoms of fatigue and malaise as early as

April 2018. But beyond the April 2018 visit, which was focused on fatigue and restless leg

syndrome, there are no records indicating Petitioner sought medical treatment for fatigue or

malaise until November 2018. Additionally, there was no medical literature filed that indicates

fatigue and malaise alone, months prior to the onset of other symptoms, are early harbingers of the

disease.

However, it cannot be ignored that on the day of vaccination, Petitioner complained of

“neurological muscle weakness” for the past six to eight weeks that was increasing in frequency.

Pet’r’s Ex. 2 at 40. Several post-vaccination medical records also indicate Petitioner had

progressive weakness before the date of vaccination. See, e.g., Pet’r’s Ex. 2 at 47 (November 30,

2018 notes indicating “gradual generalized symmetric weakness” for the past six months, which

was most noticeable in the previous two months), 59 (December 6, 2018 notes indicating she was

experiencing “gradually worsening global weakness over [six] months,” which had seemingly

become more rapid in the past two weeks), 64 (December 7, 2018 notes indicating Petitioner’s

symptoms began six months earlier and rapidly worsened in the past two weeks). Thus, Petitioner

consistently reported that her weakness began at several weeks to months prior to vaccination.

Although a neurologic examination on the date of vaccination was normal, pursuant the medical

literature, these symptoms (“muscle fatigue with feeling as though muscles giving out” and

intermittent weakness in legs, arms, and hands) are indicative of CIDP. See Pet’r’s Ex. 2 at 41;

Resp’t’s Ex. A, Tab 12. Dr. Napoli was not able to explain how Petitioner’s weakness prior to

vaccination was unrelated to her ultimate diagnosis of CIDP.

Accordingly, Petitioner has not presented preponderant evidence that her symptoms began

post vaccination. While Petitioner asserts symptom onset was approximately one week post

vaccination, the complaints of progressive weakness on the day of vaccination cannot be ignored.

Her assertions are further undercut by the medical literature filed by Respondent, characterizing

CIDP as progressive muscle weakness. Although as Dr. Napoli pointed out, there was no

documented neurologic deficits or electrodiagnostic data suggestive of GBS or CIDP prior to

vaccination, the progressive nature of the disease may explain why Petitioner did not seek medical

attention until she did. Petitioner made it clear that she had endured symptoms for several days

and sought medical counsel only after her condition continued to worsen. Because Petitioner did

not provide preponderant evidence that her symptoms began post vaccination, she is unable to

establish an appropriate temporal relationship between her vaccination and the development of her

alleged injury. Accordingly, Petitioner fails to prove Althen prong three.

C. Significant Aggravation Claim

In her motion for a ruling on the record, Petitioner, for the first time, asserted in the

alternative that Petitioner’s GBS was significantly aggravated by the flu vaccine. Pet’r’s Mot. at

2. Additional analysis is required to determine whether Petitioner’s vaccination significantly

aggravated her pre-existing injury. The elements of an off-Table significant aggravation case are

set forth in Loving. See Loving, 86 Fed. Cl. at 142–44; see also W.C. v. Sec’y of Health & Hum.

23

Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013) (holding that “the Loving case provides the correct

framework for evaluating off-table significant aggravation claims”). The Loving court combined

the Althen test with a test from Whitecotton v. Sec’y of Health & Hum. Servs. 17 F.3d 374 (Fed.

Cir. 1994), rev’d sub nom., Shalala v. Whitecotton, 514 U.S. 268 (1995) (concerning on-Table

significant aggravation cases). The resultant test has six components, which are:

(1) the person’s condition prior to administration of the vaccine, (2) the person’s

current condition (or the condition following the vaccination if that is also

pertinent), (3) whether the person’s current condition constitutes a ‘significant

aggravation’ of the person’s condition prior to vaccination, (4) a medical theory

causally connecting such a significant worsened condition to the vaccination, (5) a

logical sequence of cause and effect showing that the vaccination was the reason

for the significant aggravation, and (6) a showing of a proximate temporal

relationship between the vaccination and the significant aggravation.

Loving, 86 Fed. Cl. at 144.

As stated above, I found Petitioner did not present preponderant evidence that she has GBS.

Accordingly, evaluating a significant aggravation claim for GBS is moot. Notwithstanding that

finding, Petitioner did not present any evidence of a medical theory connecting the flu vaccine to

significantly aggravated GBS or CIDP. The medical literature cited for Althen prong one, showing

a sound and reliable medical theory connecting the flu vaccine to GBS, does not contemplate the

significant aggravation of preexisting GBS, only new onset causation. Importantly, Dr. Napoli

never opined on the significant aggravation of Petitioner’s condition and in fact denied that

Petitioner’s prior weakness was related to her current condition. See Pet’r’s Ex. 23 at 1. Moreover,

Dr. Napoli did not opine on the appropriate timeframe for significantly aggravating GBS post

vaccination. Therefore, Petitioner is unable to meet her burden pursuant to Loving.

V. Conclusion

After a careful review of the record, Petitioner has failed to provide preponderant evidence

that her November 21, 2018 flu vaccine caused or significantly aggravated her GBS or CIDP.

Accordingly, Petitioner’s claim is DENIED. Absent a timely motion for review, the Clerk is

directed to enter judgment dismissing this case for insufficient proof in accordance with Vaccine

Rule 11(a). 32

IT IS SO ORDERED.

s/Herbrina D. S Young

Herbrina D. S. Young

Special Master

32

Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of a notice

renouncing the right to seek review.

24