VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-01319
Package ID: USCOURTS-cofc-1_20-vv-01319
Petitioner: Ronald E. White
Filed: 2020-10-05
Decided: 2023-12-12
Vaccine: influenza
Vaccination date: 2017-11-01
Condition: Guillain-Barré syndrome (GBS)
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On October 5, 2020, Ronald E. White, born August 1, 1947, filed a petition seeking compensation under the National Vaccine Injury Compensation Program. He alleged that an influenza vaccine administered on November 1, 2017, caused him to develop Guillain-Barré syndrome (GBS). Mr. White had a pre-existing condition of chronic right lower extremity atrophy and weakness from a childhood polio infection, requiring a brace and later a walker for ambulation. His medical history also included hyperlipidemia, benign prostate hypertrophy, prostatitis, gastroesophageal reflux disease, carpal tunnel, and obesity. 

Mr. White presented to a MinuteClinic on December 5, 2017, with a two-day history of non-productive cough, nasal congestion, runny nose, and fatigue, along with a temperature of 99.6 degrees. He was diagnosed with a viral infection. Five days later, on December 10, 2017, he presented to the Emergency Department (ED) with generalized weakness that began approximately ten hours prior, accompanied by ongoing upper respiratory infection (URI) symptoms that had persisted for ten days. He reported a fever several days before, cough, wheezing, and congestion. At the ED, he displayed +2/5 motor strength in all extremities and absent patellar reflexes. His white blood cell count was elevated. Concerned about GBS, he was transferred to Carolinas Medical Center. 

During his hospitalization, Mr. White's neurological condition worsened, and he was intubated on December 13, 2017. On December 14, 2017, a sputum sample revealed an H. influenzae infection. His chest X-ray showed worsening findings in both lungs. He received antibiotics and a tracheostomy. His differential diagnosis upon discharge included GBS and H. influenzae pneumonia. He was discharged to a long-term acute care hospital and later to inpatient rehabilitation, continuing to require significant assistance with mobility and self-care. In May 2018, he was discharged home with assistive devices. A note from May 28, 2018, stated he was diagnosed with GBS after a flu shot and about a week and a half of cold symptoms. In December 2018, his PCP noted sequelae from GBS, stating it developed after a flu vaccine two years prior. In August 2019, he underwent coronary bypass surgery, and a post-operative neurology consultation noted a history of GBS secondary to H. influenzae. 

Chief Special Master Brian H. Corcoran found that Mr. White met the initial requirements for a Table claim for flu vaccine-related GBS, with symptom onset 39 days after vaccination, which falls within the 3 to 42-day window. However, the government argued that an H. influenzae bacterial infection was the sole substantial cause of his GBS. The Chief Special Master agreed, finding that medical literature and expert testimony supported the conclusion that respiratory infections, including those caused by H. influenzae, are more likely to cause GBS than the flu vaccine. He determined that the evidence preponderantly supported that the H. influenzae infection was the more likely sole substantial factor causing Mr. White's GBS, thereby excluding the vaccine as a substantial factor. 

Mr. White sought review of this decision. The Court of Federal Claims, Judge Thompson M. Dietz presiding, reviewed the Chief Special Master's decision. The Court found that the Chief Special Master's factual findings were rationally based on the record evidence, including Mr. White's statements, treating physician notes, and test results. The Court also found that the Chief Special Master correctly applied the legal standards regarding causation and the government's burden to prove an unrelated factor. The Court concluded that Mr. White had not demonstrated that the Chief Special Master's decision was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. 

Therefore, the Court denied Mr. White's motion for review and sustained the Chief Special Master's decision denying entitlement to compensation.

Theory of causation field:
Petitioner Ronald E. White, age 70, received an influenza vaccine on November 1, 2017, and subsequently developed Guillain-Barré syndrome (GBS). The petition alleged a Table claim for flu vaccine-induced GBS. The Chief Special Master (CSM) found Petitioner met the Table requirements (vaccination, GBS diagnosis, onset within 3-42 days). However, the CSM found Respondent carried the burden to prove an unrelated factor, concluding that an H. influenzae bacterial infection was the sole substantial factor causing Petitioner's GBS. Petitioner's expert, Dr. Lawrence Steinman, opined the flu vaccine caused GBS via molecular mimicry and questioned the H. influenzae infection's role, noting ambiguity in its confirmation. Respondent's expert, Dr. Kathleen Collins, opined that respiratory infections, including H. influenzae, are a greater risk factor for GBS than the flu vaccine, and that Petitioner's URI symptoms and subsequent H. influenzae diagnosis were the more likely cause. The CSM weighed the evidence, crediting Dr. Collins's assessment and medical literature associating H. influenzae infections with GBS, and found the infection predated and was the sole substantial cause of Petitioner's GBS, excluding the vaccine. The Court of Federal Claims affirmed the CSM's decision, finding the factual findings and legal conclusions were not arbitrary, capricious, or contrary to law. Petitioner's claim was denied. Attorneys: Lisa Annette Roquemore for Petitioner; Meghan Murphy for Respondent. Special Master: Brian H. Corcoran. Judge: Thompson M. Dietz. Decision Date: December 12, 2023.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-01319-0
Date issued/filed: 2023-06-27
Pages: 25
Docket text: PUBLIC DECISION (Originally filed: 06/02/2023) regarding 34 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (saj) Service on parties made.
--------------------------------------------------------------------------------
Case 1:20-vv-01319-TMD Document 35 Filed 06/27/23 Page 1 of 25
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-1319V
(to be published)
* * * * * * * * * * * * * * * * * * * * * * * * *
RONALD E. WHITE, *
* Chief Special Master Corcoran
*
Petitioner, * Filed: June 2, 2023
*
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Lisa Annette Roquemore, Law Offices of Lisa A. Roquemore, Rancho Santa Margarita, CA, for
Petitioner.
Meghan Murphy, U.S. Department of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION1
On October 5, 2020, Ronald E. White filed this action seeking compensation under the
National Vaccine Injury Compensation Program (the “Program”).2 ECF No. 1. Petitioner alleges
that an influenza (“flu”) vaccine he received on November 1, 2017, caused him to incur Guillain-
Barré syndrome (“GBS”). Id.
1 As provided by 42 U.S.C. § 300aa-12(d)(4)(B), the parties may object to the published Decision’s inclusion of certain
kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen (14) days within
which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or
financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure
of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire
Decision will be available to the public in its current form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the
Act”]. Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

Case 1:20-vv-01319-TMD Document 35 Filed 06/27/23 Page 2 of 25
It appeared readily evident from the record that Petitioner could likely meet the elements
of a Table flu-GBS claim. But because Respondent argued that evidence supported an alternative
cause for Petitioner’s injury, I proposed that the parties brief the matter, with Respondent tasked
with showing that (after the burden shifted) he could carry his burden. See Respondent’s Motion,
dated May 31, 2022 (ECF No. 26) (“Mot.”); Petitioner’s Opposition, dated August 1, 2022 (ECF
No. 28) (“Opp.”); Respondent’s Reply, dated October 31, 2022 (ECF No. 32) (“Reply”).
Now, having reviewed the above plus the filed medical records, expert reports, and
associated literature, I hereby deny an entitlement award. As discussed in greater detail below,
Respondent has carried his burden of demonstrating that a “factor unrelated”—namely an ongoing
respiratory infection (“URI”) caused by a Haemophilus influenza (“H. influenza”) bacterial
infection—was the more likely explanation for Petitioner’s GBS.
I. Fact History
Petitioner was born on August 1, 1947. Ex. 3 at 1. Petitioner’s pre-vaccination medical
history included a childhood polio infection that caused chronic right lower extremity atrophy and
weakness for which he wore a brace on his right leg. Ex. 1 at 38; Ex. 3 at 20. Beginning in January
2017, Petitioner also required a walker for ambulation, secondary to his post-polio weakness. Ex.
1 at 38. His history was otherwise significant for hyperlipidemia, benign prostate hypertrophy,
prostatitis, gastroesophageal reflux disease, carpal tunnel, and obesity.3 Ex. 3 at 13, 18; Ex. 4 at
63; Ex. 7 at 4, 108, 259.
Vaccination and Hospitalization
On November 1, 2017, Petitioner received a flu vaccine in his left deltoid at the office of
his primary care physician (“PCP”) by William Larsen, M.D. Ex. 3 at 13–17, 54. His PCP noted
Petitioner’s “post-polio stigmata,” but did not document anything else on physical examination.
Id. at 13–17. There is no medical record evidence of any immediate reaction to the vaccine, or
close-in-time malaise or other concerns.
Thirty-four days later, on December 5, 2017, Petitioner presented to a local CVS
MinuteClinic complaining of a non-productive cough, nasal congestion, runny nose, and
generalized fatigue that had lasted for two days. Ex. 5 at 3–4. Petitioner had a temperature of 99.6
degrees, and on exam displayed bilateral middle ear effusions, mucosal edema and rhinorrhea, an
irritated throat, and decreased breath sounds in his right middle lung field. Id. at 3, 5. The nurse
practitioner diagnosed him with a viral infection and prescribed benzonatate, a non-narcotic cough
suppressant. Id.
3 In addition, both of Petitioner’s parents had a significant cardiac history, and his mother had Parkinson’s Disease.
Ex. 4 at 8; Ex. 7 at 3980.
2

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On December 10, 2017, Petitioner went to the Atrium Health Harrisburg Emergency
Department (“ED”), complaining of generalized weakness that he reported had begun
approximately ten hours earlier that same day. Ex. 7 at 143–45. Petitioner also noted ongoing URI
symptoms that he said had begun ten days prior but had not improved. Id. at 143. Thus, Petitioner
stated that he had a fever several days ago, cough, wheezing, and congestion, and was self-treating
with over-the-counter medications and prescriptions. Id. at 143, 196. Now, however, he had more
recently begun to experience increased weakness in his legs, and difficulty walking earlier that day
that led to a fall. Id. at 143. He had a temperature of 97.9 degrees (and thus was afebrile). Id. at
144.
Upon examination, Petitioner displayed +2/5 motor strength in all extremities, and the
physician could not elicit patellar reflexes. Ex. 7 at 144–45. A head CT showed no acute findings,
and Petitioner’s chest X-ray was normal. Id. at 147–48. Petitioner’s lab work revealed an elevated
white blood cell count of 12.9, with elevated absolute neutrophils of 9.7. Id. at 179; Ex. 1 at 338.
Based upon these findings, the ED physician expressed concern about the possibility of GBS, and
therefore ordered Petitioner to be transferred to a facility that had plasmapheresis capabilities. Ex.
7 at 145. But treaters continued to report Petitioner’s concurrent URI symptoms, noting that he
likely was experiencing a viral illness.4 Ex. 1 at 38, 49, 146, 154, 164, 174, 184, 200, 205, 226,
228–29, 257, 268, 316.
Later that day, Petitioner was transferred to Carolinas Medical Center for further evaluation
and treatment, and admitted to the intensive care unit (“ICU”) for close monitoring of his
respiratory status.5 Ex. 1 at 341. Due to the rapid progression of his ascending paralysis,
Petitioner’s physicians expressed the concern that he might have an underlying structural
abnormality, but MRI imaging of his brain and cervical spine did not confirm the existence of such
issues. Id. at 23, 305, 314. Petitioner’s lumbar puncture also did not show an elevated protein level,
but given his clinical presentation he was suspected to have GBS. and was therefore started on
plasmapheresis. Id. at 305, 314.
Cerebrospinal fluid testing performed at this time did not detect the presence of the herpes
simplex virus. Ex. 1 at 466, 502. Nevertheless, throughout Petitioner’s hospitalization, many of
his treating physicians opined or speculated that his neurologic, GBS-like symptoms were
associated with his preceding/ongoing respiratory infection. See, e.g., Ex. 1 at 43 (“recent/ongoing
4 In following years, and on a few occasions, treaters entertained the possibility that Petitioner had an allergic reaction
from the vaccine, though these instances did not dispute or discuss Petitioner’s URI infection. Ex. 2 at 7; Ex. 3 at 2,
5, 8; Ex. 6 at 79.
5 An addendum was made the following day, December 11, 2017, by Samantha Dreyer, M.D., recounting the events
of the day before but noting that Petitioner had reported that he suffered from a “head cold” for the past ten days, and
it was thus decided that he remain in the ICU because he was at risk for respiratory compromise. Ex. 1 at 38. In this
same record, however, Dr. Dreyer incorrectly noted that Petitioner had received no vaccines that year. Id.
3

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URI all are highly suggestive of GBS), 200 (“bad URI 10 days prior to presentation”), 205
(“complaints of 10-day history of viral URI with onset of bilateral lower extremity weakness”),
228 (same), 241 (same), 301 (“[r]eport recent [] viral type syndrome”). No treaters at this time
proposed his more recent symptoms had anything to do with the flu vaccine he had received almost
six weeks before.
Despite initially responding well to plasmapheresis treatment, Petitioner’s neurological
condition continued to worsen, and he was intubated on December 13, 2017. Ex. 1 at 301. He was
areflexic and had +1 motor strength in all extremities. Id. at 306. Then, on December 14, 2017, a
sputum6 sample from Petitioner’s lungs was taken and the culture of it revealed an H. influenzae
infection. Ex. 1 at 27–28. Petitioner’s blood cultures were negative for bacteria, however. Id. at
28; Ex. 7 at 215. He had worsening chest X-ray findings in both his lungs. Ex. 1 at 451. Petitioner
was given a seven-day course of IV antibiotics and a tracheostomy placed due to suspected
prolonged course towards recovery. Id. at 144; Ex. 7 at 215.
On December 20, 2017, Petitioner was transferred from the ICU to a progressive unit for
ventilator weaning. Ex. 1 at 185. His course was complicated by an ileus and two acute episodes
of urinary retention. Id. at 7, 111. Petitioner underwent an extensive work up to rule out GBS
mimics including arsenic poisoning, Lyme disease,7 HSV, neurosyphilis, and B1 deficiency; none
were deemed the cause of Petitioner’s condition. Id. at 2–8, 26. However, throughout his
hospitalization and even after his discharge, there were numerous occasions where treaters
continued to repeat the hospital summary that Petitioner likely had experienced H. influenza
pneumonia. Ex. 1 at 50, 83, 90, 102, 111, 123, 146, 165, 185, 200. Petitioner received seven total
plasmapheresis (“PLEX”) sessions, the last of which was completed on December 21, 2017. Id. at
174. Upon discharge, the differential diagnosis included GBS and H. influenzae pneumonia. Ex. 1
at 2.
Post-Discharge Health
Petitioner was discharged to a long-term acute care hospital on December 28, 2017, where
he continued to improve. Ex. 2 at 7. On January 24, 2018, Petitioner was then transferred to
inpatient rehabilitation at Carolinas Rehabilitation Northeast, showing even more progress toward
better health. Id. at 2. He remained dependent on assistance with all movement, requiring a
wheelchair for ambulation and complete assistance with transfers to and from the bed and
6 Sputum is defined as a “matter ejected from the respiratory tract through the mouth.” Sputum, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=46835&searchterm=sputum (last visited
Apr. 18, 2023).
7 In the midst of his workup, Petitioner also underwent a Lyme draw that was borderline positive, but he had no risk
factors or other clinical signs or symptoms for Lyme disease, so it was proposed that this was likely a false positive.
Ex. 1 at 46–47, 88.
4

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bathroom. Id. at 8. By February 16, 2018, Petitioner was still unable to feed, bathe, or groom
himself, and was discharged to a skilled care facility for further care. Id. at 8–9. Records from this
time revealed mention of his prior receipt of the flu vaccine, although they do not also include
treater speculation of a GBS-vaccine association. Ex. 2 at 7, 10.
Petitioner subsequently spent three months at a different rehabilitation facility. He was
discharged in May 2018, and although he had improved he required a wheelchair, hospital bed,
Hoyer lift, and bedside commode for home use. Ex. 2 at 63. Through the early fall of 2018,
Petitioner received home nursing care, including home physical and occupational therapy. Ex. 6
at 4–563. During one of his initial care visits (on May 28, 2018), it was reported that Petitioner
had been “diagnosed with GBS after having a flu shot and about a week and a half of cold
symptoms, which was associated with weakness and an overall decline in functional status.” Ex.
6 at 79.
On December 6, 2018, Petitioner saw his PCP Catherine Norton, M.D., at Northwest
Family Physicians for a yearly physical exam. Ex. 3 at 7. Dr. Norton noted that Petitioner still
wore a right leg brace for his post-polio syndrome and continued to have sequelae from GBS
(which the record states he developed after a flu vaccine two years prior). Id. Dr. Norton did not
conduct a musculoskeletal or detailed neurological exam as part of her assessment. Id. at 7–12.
On March 25, 2019, Petitioner returned to Northwest Family Physicians for a productive
cough and was diagnosed with bronchitis. Ex. 3 at 4–6. At that time, Petitioner was unable to stand
on his own for longer than a few seconds and required a hospital bed for a change in position,
ability to prevent decubitus ulceration, and facilitate getting in and out of bed for adequate sleep.
Id. He also needed a wheelchair for ambulation. Id.
In August of 2019, Petitioner suffered a heart attack and underwent a coronary bypass
surgery at Carolinas Medical Center, where he was admitted from August 13-September 5, 2019.
Ex. 7 at 3926–27. Petitioner was noted to have worsened left upper extremity weakness following
surgery and had a neurology consultation due to concern for post-operative stroke. Id. Upon
examination by neurologist Paul Weaver, D.O., he found Petitioner to have +5/5 bilateral upper
extremity and left lower extremity motor strength and +4/5 right lower extremity strength. Id. at
3980. Dr. Weaver noted that Petitioner had a history of GBS “secondary to H. influenza.” Id. at
3979. Petitioner’s head CT was negative for acute findings and the neurology service felt that
Petitioner had no findings significant for an acute stroke, nor did he have worsened deficits. Dr.
Weaver recommended that Petitioner wean his narcotics usage and recommended rehabilitation to
increase his strength following hospitalization. Id. at 4000.
On September 19, 2019, Petitioner saw cardiologist Kiran Venkatesh, M.D., for follow up
after his bypass surgery, and no musculoskeletal complaints were documented at this visit. Ex. 7
5

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at 6567. Petitioner received home care from Bayada Home Health Care from October 24, 2019
through December 17, 2019 for occupational and physical therapy to increase his strength
following his hospitalization for bypass surgery. Ex. 6 at 570–739. As of 2020, Petitioner was
regularly being treated for diabetes by Peter Nguyen, D.O., at Harrisburg Family Physicians. Ex.
7 at 28–29; Ex. 8 at 68–72. It is not evident from these later records whether Petitioner by this time
continued to suffer from the effects of his previously-diagnosed GBS.
II. Expert Reports
A. Petitioner’s Expert – Lawrence Steinman, M.D.
Dr. Steinman, a neurologist, prepared two written reports for the Petitioner.8 Report, dated
October 1, 2021, filed as Ex. 9 (ECF No. 22-1) (“Steinman First Rep.”); Report, dated August 1,
2022, filed as Ex. 32 (ECF No. 27-1) (“Steinman Second Rep.”). Given the nature of the parties’
dispute, the most relevant portion of his opinion related to questioning the role Petitioner’s H.
Influenza infection could have played in causing his GBS. Steinman First Rep. at 1.
As shown in his CV, Dr. Steinman received his undergraduate degree from Dartmouth
College, and his medical degree from Harvard Medical School. Curriculum Vitae, filed as Ex. 10
on October 1, 2021 (ECF No. 22-2) (“Steinman CV”) at 1. He then completed residencies in
neurology and pediatrics at Stanford University. Id. He has worked as a professor of neurology
and pediatrics at Stanford for the past 41 years. Id.; Steinman First Rep. at 2. He is board certified
in neurology from the American Board of Psychiatry and Neurology. Steinman CV at 2. Dr.
Steinman has also published hundreds of peer-reviewed publications on neurology and
autoimmune disease. Id. at 5–49. He holds several patents related to the diagnosis and treatment
of autoimmune and demyelinating diseases. Id. at 2–3. He presently serves as the George A.
Zimmerman Professor of Neurological Sciences, Neurology, Genetics and Pediatrics at Stanford
University. Id. at 1.
First Report
Dr. Steinman began his report with a summary of the medical records, accepting
Petitioner’s GBS diagnosis. Steinman First Rep. at 4–7. He then outlined the scientific theory of
molecular mimicry and its relevance to GBS’s mechanistic process. Id. at 7–8, 10; see L. Steinman,
Autoimmune Disease, Scientific Am. 106, 109 (1993), filed as Ex. 17 (ECF No. 22-9) (“Steinman
8 Dr. Steinman’s two filed reports totaled 34 pages—comparatively less than what he has prepared in many other
cases. However, Dr. Steinman has a long-standing propensity for cutting and pasting sections taken wholesale from
earlier reports, and thus repeating points not always specific to the case at hand. See, e.g., Trollinger v. Sec'y of Health
& Hum. Servs., No. 16-473V, 2023 WL 2521912, at *3 n.7 (Fed. Cl. Spec. Mstr. Feb. 17, 2023), mot. for review
docketed (Fed. Cl. Mar. 17, 2023). Pierson v. Sec'y of Health & Hum. Servs., No. 17-1136V, 2022 WL 322836, at
*12–13 (Fed. Cl. Spec. Mstr. Jan. 19, 2022) (copying sections from prior reports); Gross v. Sec'y of Health & Hum.
Servs., No. 17-1075V, 2022 WL 9669651, at *15–18 (Fed. Cl. Spec. Mstr. Sept. 22, 2022) (same). He has done so
once again in this case.
6

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I”) (sharing how structures on a virus or bacteria or in a vaccine can trigger a cross-reactive
response to the self); see also S.S. Ahmed et al., Antibodies to Influenza Nucleoprotein Cross-
React with Human Hypocretin Receptor 2, 7 Sci. Translational Med. 1, 1 (2015), filed as Ex. 18
(ECF No. 22-10) (describing the role of molecular mimics in the flu vaccine and narcolepsy). He
also discussed what degree of homology between viral amino acids and myelin basic protein - the
anticipated situs of attack for a demyelinating condition—would be necessary to support his
theory, as well as some specific amino acid sequences likely involved. Steinman First Rep. at 11–
21. (Because this case does not turn on the capacity of the flu vaccine to cause GBS, I do not
include an extensive review of this aspect of Dr. Steinman’s opinion).
Dr. Steinman next considered record evidence pertaining to the dual or competing roles of
the vaccine and H. influenza in Petitioner’s injury. Steinman First Rep. at 22. Dr. Steinman opined
that Petitioner’s GBS was more likely caused by his flu vaccination. Id. He acknowledged that the
H. influenza infection might be causally associated with GBS. Id. at 9; Y.Y. Ju et al., Haemophilus
Influenzae as a Possible Cause of Guillain–Barre´ Syndrome, 149 J. Neuroimmunology 160, 160
(2004), filed as Ex. 19 (ECF No. 25-20) (“Ju”) (“there is a possible but rare association of GBS
with nonencapsulated H. influenzae in the UK”). But even assuming Petitioner experienced a wild
H. Influenza infection prior to his GBS onset (something he maintained was unclear from the
records) the flu vaccine was still likely also a substantial factor in Petitioner’s injury (although
offered this assertion in conclusory form). Id.
One point Dr. Steinman made in regard to infection causality was the existence of record
ambiguity about the extent or scope of a pre-onset infection. Petitioner’s medical records clearly
noted his vaccination, and on some occasions (reported months or years after the onset of
symptoms), treaters entertained the possibility of some vaccine-injury association or that it
provoked some allergic reaction. Ex. 2 at 7; Ex. 3 at 2, 5, 8; Ex. 6 at 79. By contrast, though tests
revealed the presence of H. influenza in the Petitioner’s sputum, blood cultures had not also
confirmed its existence. Steinman First Rep. at 9, 22–23; Ex. 7 at 215. Dr. Steinman also noted
that the sputum cultures were not confirmed as positive until December 14th—after Petitioner was
already hospitalized with GBS, further casting doubt on the role of the H. influenza infection in
relation to Petitioner’s GBS. Steinman First Rep. at 9, 22–23. Dr. Steinman did not, however,
comment on or discuss the record evidence that (prior to the sputum testing) Petitioner had been
sick with some kind of infection—and that these symptoms unquestionably pre-date GBS onset.
Second Report
Dr. Steinman’s Second Report spent additional time defending the putative GBS-flu
vaccine association, as well as his methodology used to test it. Steinman Second Rep. at 2–7. But
he also addressed in some greater detail the more central question of whether Petitioner’s H.
Influenza infection could have been causal of his GBS. He again acknowledged the possibility that
7

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H. influenza might be a factor, referencing his citation to Ju. Steinman Second Rep. at 1; Ju at 166.
However, he opined that H. influenza was only rarely associated with GBS—whereas the flu
vaccine is “presumed causative” of GBS (at least in the context of a Table claim). Steinman Second
Rep. at 1. He also maintained that one of Dr. Collins’s references acknowledged a possible small
increased risk of GBS follow receipt of the flu vaccine. F. DeStefano et al., Principal
Controversies in Vaccine Safety in the United States, Clinical Infectious Diseases 1, 4 (2019), filed
as Ex. A-9 (ECF No. 25-10) (“DeStefano”). DeStefano is a review article that summarizes findings
about what it deemed “the main current vaccine safety controversies in the United States,”
including the flu vaccine-GBS association. DeStefano at 1. However, although DeStefano’s
authors agreed that some vaccine-GBS association has been found, it characterized the
association/risk as “small and less than the increase in risk following natural influenza infection.”
Id. at 4 (emphasis added). DeStefano makes no mention of any H. influenza wild infection risk.
In addition, Dr. Steinman reiterated his argument that the evidence Petitioner had even
experienced an H. Influenza infection was weak. Here, the lab results confirming the existence of
an H. influenza infection were obtained post-hospitalization and remained “ambiguous,” leaving
the unquestionable fact of the flu vaccine as the likely cause of Petitioner’s GBS. Steinman Second
Rep. at 7. Even if an H. influenza infection might play a role in causing GBS, the vaccine remained
a substantial factor in this case, without which Petitioner would not likely have experienced GBS.
Id. In fact, Dr. Steinman maintained that both the H. influenza and flu vaccine could very well
have combined to cause a “synergistic effect.” Id.
B. Respondent’s Expert – Kathleen L. Collins, M.D., Ph.D.
Dr. Collins submitted two expert reports on behalf of Respondent. Report, dated as
February 11, 2022, filed as Ex. A (ECF No. 25-1) (“First Collins Rep.”); Report, dated as
November 29, 2022, filed as Ex. C (ECF No. 33-1) (“Second Collins Rep.”).
Dr. Collins received her undergraduate degree from Wellesley College, and her medical
and doctorate degrees from John Hopkins University School of Medicine. Curriculum Vitae, filed
as Ex. B on February 11, 2022 (ECF No. 25-24) (“Collins CV”) at 1. She then had postdoctoral
training in Internal Medicine at the Brigham and Women's Hospital, Infectious Disease Clinical
Fellow, Research Fellow at Harvard University, and a Postdoctoral Fellowship at the
Massachusetts Institute of Technology. Id. Dr. Collins has been a faculty member at the University
of Michigan's Medical School since 1998, where she teaches on internal medicine. Id.; Collins
First Rep. at 1. She is board certified in infectious disease. Collins CV at 7. She also runs a research
laboratory at the University of Michigan that studies molecular mechanisms of human
immunodeficiency virus (“HIV”) persistence and has over 70 publications on the topic. Id. at 15–
21; Collins CV at 1.
8

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First Report
Dr. Collins summarized the pertinent medical records before giving her primary opinion.
Collins First Rep. at 2–5.9 She acknowledged that GBS attributable to the flu vaccine, as alleged
here, is an accepted Vaccine Injury Table claim. Collins First Rep. at 6–8. But numerous studies
have examined the risk of GBS following receipt of the vaccine, with results demonstrating that
the risk is significantly less than that following an acute respiratory infection. Id. at 6-8; C. Tam et
al., Guillain-Barre´ Syndrome and Preceding Infection with Campylobacter, Influenza and
Epstein-Barr Virus in the General Practice Research Database, 2 PLoS One 1, 5 (2007), filed as
Ex. A-4 (ECF No. 25-5) (“Tam”) (reporting evidence of a protective effect of the flu vaccination
on GBS risk, and confirming associations between infection due to influenza-like illnesses and
GBS (along with other types of infections)). Other evidence of the infection/GBS association was
referenced by Dr. Collins and deemed equally reliable and persuasive. Collins First Rep. at 8–10.
For example, Campylobacter jejuni10 infections are commonly discussed in association with cases
of GBS.11 Collins First Rep. at 8–9. As Dr. Collins noted, Tam observed that a recent prior
infection of C. jejuni had been reported in 26-60 percent of GBS cases, and thus there was up to a
60-fold increased risk of GBS after a C. jejuni infection. Collins First Rep. at 9; Tam at 5.
More relevant to this case, Dr. Collins cited literature supporting the contention that H.
influenzae can also cause the kind of acute respiratory infections that increase the risk for
developing GBS. Collins First Rep. at 10; Ju at 165–66 (determining that six GBS patients had
elevated anti-Haemophilus influenzae antibodies compared with only one in normal controls,
suggesting a possible association); M. Mori et al., Haemophilus Influenzae Infection and Guillain–
Barre´ Syndrome, 123 Brain 2171, 2171 (2000), filed as Ex. A-20 (ECF No. 25-21) (“Mori”)
9 Just as Dr. Steinman devoted much of his first report to discussing things not really in dispute, such as the capacity
of the flu vaccine to cause GBS (and specifically how), Dr. Collins offered testimony and evidence to rebut that
association. Collins First Rep. at 11-12. But these aspects of her reported opinion need not be exhaustively evaluated,
since (as I have already observed) the case’s resolution turns far more on whether the H. Influenza wild infection can
cause GBS, and more likely did so here.
10 Dr. Collins defined Campylobacter jejuni as a bacterial pathogen that causes a gastrointestinal illness in humans.
Collins First Rep. at 8.
11 The GBS variant most associated with C. jejuni is acute motor axonal neuropathology (“AMAN”). Collins First
Rep. at 9. Through molecular mimicry, it is thought that an abnormal antibody response against C. jejuni cross reacts
with components of nerve axons to cause AMAN. Id.; A. Hahn, Guillain–Barre Syndrome, 352 Lancet 635, 635–36
(1998), filed as Ex. A-14 (ECF No. 25-15); P. van Doorn et al., Clinical Features, Pathogenesis, and Treatment of
Guillain-Barré Syndrome, 7 Lancet 939, 941 (2008), filed as Ex. A-15 (ECF No. 25-16); N. Yuki et al., Carbohydrate
Mimicry Between Human Ganglioside GM1 and Campylobacter jejuni Lipooligosaccharide Causes Guillain-Barre
Syndrome, 101 Proceedings Nat’l Acad. Sci’s 11404, 11405–06 (2004), filed as Ex. A-16 (ECF No. 25-17). This cross
reaction was proposed due to a linkage between AMAN to antibodies that recognize a complex lipid called
monosialoganglioside. N. Yuki et al., Animal Model of Axonal Guillain-Barre Syndrome Induced by Sensitization
with GM1 Ganglioside, 49 Annals Neurology 712, 716 (2001), filed as Ex. A-17 (ECF No. 25-18). Another type of
GBS, acute inflammatory demyelinating polyradiculoneuropathy, is less understood but can also be associated with
C. jejuni. Collins First Rep. at 9; Tam at 1.
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(finding elevated anti- H. influenzae antibodies in 13 percent of GBS patients, but not in any of
the other two control groups); S. Nafissi et al., The Role of Cytomegalovirus, Haemophilus
Influenzae and Epstein Barr Virus in Guillain Barre Syndrome, 51 Acta Medica Iranica 372, 375
(2013), filed as Ex. A-21 (ECF No. 25-22) (“Nafissi”) (concluding that 82.9 percent of cases had
an H. Influenza or EBV infection preceding GBS, as compared to 29 percent of the control;
respiratory and gastrointestinal infection was found in 57.1 and 20 percent of cases, respectively).
By contrast, the risk from vaccination was routinely deemed lesser, even if it existed as
well. See, e.g., J. Stowe et al., Investigation of the Temporal Association of Guillain-Barre´
Syndrome with Influenza Vaccine and Influenza like Illness Using the United Kingdom General
Practice Research Database, 169 Am. J. Epidemiology 382, 385–86 (2008), filed as Ex. A-5 (ECF
No. 25-6) (“Stowe”) (epidemiologic study looking at three risk periods (0-30 days, 31-60 days,
and 61-90 days) after vaccination or influenza like infection derived from UK data from 1990 to
2005, finding no evidence of an increased risk of GBS after the seasonal flu vaccine); L. Grimaldi-
Bensouda et al., Guillain-Barre´ Syndrome, Influenza like Illnesses, and Influenza Vaccination
During Seasons with and Without Circulating A/H1N1 Viruses, 174 Am. J. Epidemiology 326,
326 (2011), filed as Ex. A-6 (ECF No. 25-7) (“Grimaldi-Bensouda”). Grimaldi-Bensouda
examined all incidents of GBS cases meeting broadly-accepted classification criteria that were
diagnosed at 25 neurology centers in France between March 2007 and June 2010, concluding there
were no concerns regarding GBS risk from modern flu vaccination. Collins First Rep. at 6–7.
Based on the above, Dr. Collins maintained that it was more likely than not that a prior
infection evident from this record had caused Petitioner’s GBS. Collins First Rep. at 10. She notes
that Mr. White experienced an acute respiratory infection with a ten-day history of symptoms prior
to the development of his neurological symptoms. Id. He displayed an elevated white blood cell
count and an abnormal chest X-ray, and science associates respiratory infection by a bacterial
pathogen (H. influenzae) with GBS. Collins First Rep. at 10. In addition, on numerous occasions
treaters stated that Petitioner had likely experienced H. influenzae-caused pneumonia. Collins First
Rep. at 11; Ex. 1 at 50, 83, 90, 102, 111, 123, 146, 165, 185, 200.
Dr. Collins did not deem Dr. Steinman’s contrary opinion to be persuasive. Collins First
Rep. at 10–12. First, she took issue with his contention that the lack of blood testing confirmation
of the presence of an H. Influenza infection undermined the positive sputum findings. Collins First
Rep. at 11 (discussing Steinman First Rep. at 22–23). In so doing, Dr. Collins underscored her
expertise in the study of infectious disease, maintaining that Dr. Steinman’s weighing of these
items of evidence was in error (especially since his experience is in neurology). Collins First Rep.
at 11. A patient suffering from pneumonia would not be expected to have positive blood cultures,
she argued, and the negative findings merely established that the infection had not spread to his
blood. Collins First Rep. at 11. By contrast, evidence of growth of H. influenzae plus the presence
of bacteria and white blood cells observed in the lung specimen under the microscope by gram
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stain stood as more conclusive evidence of Petitioner’s H. influenzae bacterial infection. Collins
First Rep. at 11. And the diagnosis of pneumonia was further supported by chest X-ray findings
revealing worsening in both his lungs. Collins First Rep. at 11; Ex. 1 at 451.
Second, Dr. Steinman had referenced record statements by two treaters suggesting that
Petitioner was allergic or had a contraindication to the flu vaccine, but Dr. Steinman had not also
pointed to evidence that Petitioner had signs of any allergic response in the first place. Collins First
Rep. at 12. In contrast, at least 14 treaters associated Petitioner’s upper respiratory infection with
the development of his GBS. Collins First Rep. at 12; Ex. 1 at 38, 49, 146, 154, 164, 174, 184,
200, 205, 226, 228–29, 257, 268, 316. The weight of treater views clearly favored the infection
over vaccination as causal.
Dr. Collins concluded by commenting on onset timing, offering the opinion that Petitioner
likely acquired the H. influenzae infection before he was hospitalized with GBS. Collins First Rep.
at 11. She interpreted the record to be consistent with the infection beginning as an upper
respiratory infection (documented prior to the development of weakness) but subsequently
developing into a lower respiratory infection over time. Collins First Rep. at 11. H. influenzae is a
relatively common cause of both upper and lower respiratory infection, but uncommonly
associated with pneumonia acquired after hospitalization.12 Collins First Rep. at 11. And the record
clearly established that he had an upper respiratory infection for ten days prior to developing GBS.
Collins First Rep. at 10. The fact that the sputum culture that revealed the infection was performed
after Petitioner’s GBS onset was not evidence that the infection itself followed GBS, given the
ample evidence from before onset of neurologic symptoms that he was already suffering from a
respiratory infection (e.g., nasal drainage, subjective fevers, cough, congestion, fluid in the middle
ear, and an elevated white blood cell count). Id. at 11; Ex. 1 at 338; Ex. 5 at 3–5; Ex. 7 at 143, 179.
Second Report
Putting aside arguments aimed at Dr. Steinman’s causation theory that do not help resolve
the parties’ dispute, Dr. Collins again emphasized literature she had offered demonstrating that
acute respiratory infections (including those caused by H. influenza) are strongly associated with
GBS. Collins Second Rep. at 2. These items (which she noted Dr. Steinman had not discussed)
outweighed articles underscoring a vaccine-GBS association, like DeStefano. Id. (referencing
Nafissi at 375 and Mori at 2171). She also reiterated her prior point that the flu vaccine-GBS
association was weaker than Petitioner proposed. Collins Second Rep. at 2–3 (references omitted).
There was thus in her view more reliable evidence for an association between an upper respiratory
12 In addition, Dr. Collins addressed a reference from the medical records potentially suggesting a post-GBS onset
(“with GBS and now pneumonia,”(Ex. 7 at 607)). She argued the citation merely referred to the timing of the lower
respiratory lung infection. Collins First Rep. at 10. I have not, however, been able to locate the referenced cite.
11

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infection by a bacterial or viral pathogen (H. influenza) and GBS than between the illness and the
flu vaccine. Collins Second Rep. at 1, 4.
In addition, Dr. Collins again reviewed record evidence of the time course, signs, and
symptoms of Petitioner’s infection that she proposed had led to his injuries. Collins Second Rep.
at 1; Collins First Rep. at 11. Dr. Steinman had not, in her estimation, adequately addressed this
evidence (as well as the fact that overwhelming treater support suggested the infection was causal).
Collins Second Rep. at 2. And even if the Vaccine Program recognized a claim for GBS as a flu
vaccine injury, in the context of this case—where a competing, alternative explanation was so
evident from the record—the existence of a Table claim did not make it more likely per se the
vaccine was causal. On the contrary, she had offered evidence undermining the vaccine-GBS
association, and it was relevant to this case (since it suggested that in the context of dueling causes,
the evidence supporting a flu vaccine association was weaker than it appeared). Id.
III. Procedural History
After the case’s initiation in October 2020, this matter was originally assigned to SPU,
since it appeared to assert a flu-GBS Table claim (and thus potentially could be resolved quickly
if the claim met the Table elements). Petitioner filed medical records supporting the claim, and
then Respondent’s Rule 4(c) Report was filed on April 2, 2021 (ECF No. 14). It was thereafter
transferred out of SPU, because it was determined that the parties would likely require the use of
medical experts to address the issue of causation and/or to determine whether the flu vaccination
was a substantial factor in causing Petitioner’s GBS. ECF No. 15.
The case was assigned to my non-SPU docket, then to another special master, and then
back to me in the spring of 2021. Petitioner and Respondent then filed some of the expert reports
discussed above. ECF Nos. 22, 25. Thereafter I set a briefing schedule on the “factor unrelated”
issue, and dates for any final expert reports. Scheduling Order, dated February 17, 2022. The
parties had fully briefed the matter and filed supplemental expert reports by November 2022, and
it is now ripe for resolution.
IV. Parties’ Arguments
Petitioner argues that he has met his prima facie burden of demonstrating a Table
Injury13—he received a flu vaccine, experienced GBS, and his onset fell within three to 42 days
of vaccination. Opp. at 19, 23. The only remaining issue was whether Respondent had met his
13 Even if Petitioner did not meet the Table requirements, he asserts that he still meets all three Althen prongs for a
non-Table case. Opp. at 23–24, 26.
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burden of establishing a factor unrelated to the flu vaccine—something Petitioner denied had
occurred. Id. at 19.
Petitioner maintains that Respondent must show by a preponderance of the evidence that
the H. influenzae was the “sole and substantial cause and how the [flu] vaccine had nothing to do
with the GBS.” Id. at 19, 25; Shyface v. Sec'y, Health & Hum. Servs., 165 F.3d 1344, 1352 (Fed.
Cir. 1999). But Respondent could not exclude the vaccination completely as a causative factor.
Instead, he relied on the contention that it was statistically more probable that the infection caused
his injuries. Opp. at 21, 23, 26. But Respondent had not proposed a theory for how the infection
causes GBS, or how it caused Petitioner’s injuries in particular. Id. at 22. Petitioner also argued
that the record did not permit the conclusion as to when the H. influenzae infection likely
commenced, as his blood culture was not sampled until four days after he was hospitalized, and
his prior symptoms could simply have been the product of a “head cold.” Id. at 24, 26, 28. Thus,
Respondent failed in addressing how the vaccine had “zero impact” on Petitioner’s GBS. Id. at 19,
22.
In opposing entitlement, Respondent argues that Petitioner’s GBS was caused by a factor
unrelated to his flu vaccination—the H. influenzae infection. Mot. at 16; Reply at 6. The medical
literature demonstrates that the risk of GBS following infection is much higher than following
vaccination, and thus it has been shown that this kind of infection “can cause” GBS. Mot. at 11–
14; Reply at 8. For the logical sequence of cause and effect/“did cause” prong, Respondent
maintains that the medical records establish that Petitioner acquired the H. influenzae infection
post-vaccination, had an onset of GBS ten days after prolonged and objective, test-substantiated
documentation of a URI, and then subsequently was diagnosed with H. influenzae pneumonia.
Mot. at 10–11; Reply at 2. Respondent does not give weight to Petitioner’s argument of a single
notation discussing a “head cold,” as the countervailing weight of the evidence demonstrates that
Petitioner had a URI leading up to his hospitalization. Reply at 2–4.
In addition, Respondent notes that the vast majority of Petitioner’s treaters attributed his
GBS to his URI rather that the flu vaccine. Id. at 5–6; Mot. at 15–16. By contrast, the one treater
who attributes the flu vaccine to Petitioner’s GBS, Dr. Norton, erred in his determination. Mot. at
15–16. This treater view is expressed in a record generated a full year after Petitioner’s diagnosis
(not during his treatment). In addition, Dr. Norton’s assessment had other inaccuracies regarding
Petitioner’s GBS course. Id. Petitioner cites to another medical record that discusses a flu vaccine
and his cold symptoms before his GBS diagnosis, but this documentation was made by a physical
therapist’s evaluation six months after his hospitalization. Reply at 5. And otherwise these treater
views seem reliant on the temporal association between vaccination and GBS. Id. At bottom,
Respondent argues that based on a preponderance of the evidence, Petitioner’s H. influenzae
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infection most likely caused his GBS—but for his infection, Petitioner would not have developed
GBS.14 Mot. at 17; Reply at 6, 8–9.
V. Applicable Legal Standards
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).15
In this case, Petitioner does not assert a Table claim.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate 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)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen, 418 F.3d at 1278: “(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
14 Respondent does not discuss Shyface in his briefs, or this argument that he must prove the unrelated factor is the
“sole and substantial cause” of Petitioner’s injury to meet his burden.
15 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V,
2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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for the injury; and (3) a showing of proximate temporal relationship between vaccination and
injury.”
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). 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 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.
Cl. at 245.
In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum.
Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also LaLonde v. Sec’y of Health & Hum. Servs.,
746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply
identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of
proof” (citing Moberly, 592 F.3d at 1322)); Howard v. Sec'y of Health & Hum. Servs., No. 16-
1592V, slip op. at *6 (Fed. Cl. Feb. 27, 2023) (confirming that “[t]he standard has been
preponderance for nearly four decades”). Otherwise, petitioners always have the ultimate burden of
establishing their Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health & Hum.
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States, 133 Fed.
Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall burden of proving
causation-in-fact under the Vaccine Act” by a preponderance standard).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
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at 1367; Capizzano, 440 F.3d at 1326 (“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’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Medical records and statements of a treating physician, however, do not per se bind the
special master to adopt the conclusions of such an individual, even if they must be considered and
carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y
of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates
that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and
cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases. The views of treating physicians should be weighed against other, contrary
evidence also present in the record—including conflicting opinions among such individuals.
Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physicians’ conclusions against each other), aff’d,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must align with the theory of how the relevant vaccine can
cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.
Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,
2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denied (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Standards Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
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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.” Section 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 & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.
1993) (determining that 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 determination
is evidenced by a rational determination).
As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as
trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. 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”), aff'd, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked
propositions explains why such records deserve some weight: (i) sick people visit medical
professionals; (ii) sick people attempt to honestly report their health problems to those
professionals; and (iii) medical professionals record what they are told or observe when 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 & Hum. Servs., No. 11–685V,
2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.
Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to
conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are often 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 & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. United States 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.”)).
However, the Federal Circuit has also noted that there is no formal “presumption” that
records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health
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& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which
compelling oral or written testimony (provided in the form of an affidavit or declaration) may be
more persuasive than written records, such as where records are deemed to be incomplete or
inaccurate. Campbell v. Sec'y of Health & Hum. 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, 569 F.3d at 1379; Bradley v. Sec'y of
Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,
No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
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) 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. La Londe v. Sec'y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,
1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the
factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.
Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).
Under Daubert, the factors for analyzing the reliability of testimony are:
(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
18

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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 the Vaccine Program the Daubert factors play a slightly different role than they do when
applied in other federal judicial settings, like the district courts. Typically, Daubert factors are
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are
used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &
Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts in order to rebut a petitioner’s case.
Where both sides offer expert testimony, a special master's decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). 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, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.
Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for
review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on
a particular expert's credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court
has unambiguously explained that special masters are expected to consider the credibility of expert
witnesses in evaluating petitions for compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Both parties filed numerous items of medical and scientific literature in this case, but not
all such items factor into the outcome of this decision. While I have reviewed all the medical
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literature submitted in this case, I discuss only those articles that are most relevant to my
determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed
every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072,
2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 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 & Hum. 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”).
E. Standards for Ruling on the Record
I am resolving Petitioner’s claim on the filed record, and the parties have not challenged
my determination to do so. Mot. at 1; Opp. at 1. The Vaccine Act and Rules not only contemplate
but encourage special masters to decide petitions on the papers where (in the exercise of their
discretion) they conclude that doing so will properly and fairly resolve the case. Section
12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been
affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided
case on the papers in lieu of hearing and that decision was upheld). I am simply not required to
hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health
& Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his
discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health &
Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).
ANALYSIS
I. Petitioner Has Met His Prima Facie Burden of Proof for a Table Flu
Vaccine-GBS Claim
The parties agree that Petitioner has alleged a Table claim in this case. Mot. at 13 n.3;
Reply at 6. GBS is listed as a Table injury for the flu vaccine, and thus a claimant seeking to meet
its requirements must show (a) receipt of a covered form of the flu vaccine, (b) that the claimant
did in fact experience GBS as defined in the Table’s “qualifications and aids to interpretation,”
and (c) that onset (whether or not GBS could then be diagnosed, or was) occurred between three
and 42 days after vaccination. 42 C.F.R. § 100.3.
Here, all of these elements exist and/or have been satisfied. There is no dispute that
Petitioner received the flu vaccine, and his GBS diagnosis is not contested. Moreover, his onset
was most likely on December 10, 2017, when he first sought treatment for bilateral upper and
lower extremity weakness that he reported had begun approximately ten hours earlier that same
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day, Ex. 7 at 143. An onset 39 days post-vaccination falls within the timeframe set for a successful
Table flu-GBS claim. Thus, the record preponderantly supports the prima facie elements of
Petitioner’s Table claim—meaning that Respondent can only prevail if he carries his shifted
burden to prove a “factor unrelated.” Section 13(a)(1)(B).
II. Respondent Has Established That Mr. White’s Condition Was Caused by an
Intercurrent H. influenza Infection—a “Factor Unrelated” to the Flu Vaccine
The nature of Respondent’s “factor unrelated” burden in this case must be accurately
explained. While the evidentiary standard applicable under Althen, preponderance, also applies
even after the burden shifts, governing authority has characterized the burden on Respondent in
this context to be “higher”—or, more accurately, not literally congruent with what a petitioner
must demonstrate to receive damages, with one additional obligation not placed on claimants.
When a claimant successfully establishes a prima facie case of causation, “the burden then
shifts to the government to prove alternative causation by a preponderance of the evidence.”
Cedillo, 617 F.3d at 1338. The Vaccine Act defines “factors unrelated to the administration of the
vaccine” to be matters “documented by the petitioner's evidence or other material in the record,”
such as “infection, toxins, trauma (including birth trauma and related anoxia), or metabolic
disturbances which have no known relation to the vaccine involved, but which in the particular
case are shown to have been the agent or agents principally responsible for causing the petitioner's
illness, disability, injury, condition, or death.” Section 13(a)(2)(B) (emphasis added).
As noted by the Court of Federal Claims in Stone v. Sec'y of Health & Hum. Servs., 95 Fed.
Cl. 233, 237 (2010),
the standard for proving a “factor unrelated” is higher than the petitioner's burden of
proving a prima facie case. Although a petitioner is required to show that the vaccine was
a “substantial factor” in causing his or her injury, ‘the petitioner need not show that the
vaccine was the sole or predominant cause of her injury.’ (de Bazan, 539 F.3d at 1351).
The respondent’s burden, by contrast, is to ‘identify[ ] a particular [unrelated] factor (or
factors) and present [ ] sufficient evidence to establish that it was the sole substantial factor
in bringing about the injury.’ Id. at 1354 (emphasis added). In order to prevail, therefore,
the respondent must ‘exclude[ ] the vaccine as a substantial factor.’ Id.
Stone went on to observe that “[t]he difference between “substantial factor” and “sole substantial
factor” is a meaningful one,” noting that compensation could still be awarded even in cases where
a factor unrelated had been shown to be substantial—but not “solely” substantial. Stone, 95 F.3d
at 237 n.5 (citations omitted). This, in effect, describes what is sometimes referred to as a “Shyface
analysis”—where two factors, including vaccination, are deemed potentially causal, but one
cannot be found to predominate over the other. Shyface, 165 F.3d at 1352–53.
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In applying this standard, then, to the question of whether a factor unrelated explains an
injury, special masters must conclude that the factor unrelated was the “sole substantial factor”—
although in so doing, the evidence deemed sufficient to reach that conclusion must only be
preponderant, allowing the determination that it is “more likely than not” the factor unrelated was
the sole substantial factor. That, in turn, leaves room for doubt (just as there is doubt in any
preponderant determination that barely crosses the preponderant line). Thus, a finding that the
vaccine has been excluded must only cross the “more likely than not” line, even if Respondent
bears this obligation when petitioners never do.
In practice, special masters have found the factor unrelated burden met by Respondent
based on the same mix of evidence and weighing of items of literature versus expert testimony that
they encounter when considering Petitioner’s obligations. To give one example, after remand of
the Stone case (where Respondent maintained that a child’s Dravet syndrome was solely due to a
genetic mutation rather than vaccination), the special master was readily able to conclude under
the proper standard that Respondent had met his burden, relying on a showing that included (a)
the determination to give more weight to Respondent’s expert testimony than Petitioner’s, (b) the
highly persuasive evidence of the alternative cause, and (c) an absence of record evidence that the
vaccine itself had caused any harm to the child’s brain (as would needed to have been shown to
conclude the vaccine caused injury in accordance with the theory alleged). Stone v. Sec'y of Health
& Hum. Servs., No. 04-1041V, 2011 WL 836992. at *3 (Fed. Cl. Spec. Mstr. Jan. 20, 2011), mot.
for review den’d, 99 Fed. Cl. 187 (2011), aff’d, 676 F.3d 1373 (Fed. Cir. 2012).
Importantly for present purposes, the strength of a claimant’s prong one showing does not
per se make it less likely that the proposed factor unrelated was not the sole substantial factor
(although the evidence offered pro and con must still be weighed). And I am aware of no case law
suggesting that the mere fact a claim exists as a Table claim—or that the Table elements were met,
such that the burden has shifted—is an obstacle to Respondent successfully carrying his factor
unrelated burden. Rather, Respondent’s success in this regard must be evaluated by the same
weighing process that applies to a petitioner’s initial burden.
In this case, the record preponderantly supports Respondent’s contention that Petitioner’s
demonstrated H. Influenza infection was the more likely sole substantial factor causing Petitioner’s
GBS, and that it precipitated injury independent of Petitioner’s earlier-in-time receipt of the flu
vaccine.
First, there is reliable evidence in the medical literature demonstrating an association
between the risk of GBS following infection generally. Tam at 6–8; van Doorn at 941; Ju at 165–
66; Mori at 2171; Nafissi at 375. Some of this evidence is in fact specific to the H. influenza
infection, as well. Ju at 160. Dr. Steinman himself agreed to this association, even if he downplayed
22

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it a bit. Steinman First Rep. at 9. And though Dr. Steinman cites literature that also associates
vaccination and GBS, that risk is consistently deemed lesser in comparison (and in some studies
unfounded). See, e.g., DeStefano at 4. It has even been documented that vaccination might play a
protective role against GBS. Stowe at 385–86; Grimaldi-Bensouda at 326. Thus, Respondent has
not only offered preponderant and reliable evidence associating the relevant infection with GBS,
but he has also shown that in the general context of vaccination and infection, vaccination will
usually be less likely causal (thus helping Respondent to exclude the vaccine in this case as part
of his enhanced burden to show factor unrelated).
Petitioner argues in response that Respondent’s causation showing (under Althen’s “can
cause” prong) is insufficient, maintaining that it mostly boiled down to the contention that
probabilities favor infection over vaccine, without much scientific showing. Opp. at 21–23, 26.
But it is well understood in the Vaccine Program that no one kind of evidence is needed to prove
any of the Althen prongs—and thus that different combinations or mixes will prove sufficient in
different contexts. Moreover, having had the occasion to resolve many cases in which a variety of
vaccines are proposed to have been causal of nerve demyelinating injuries like GBS, I deem it
almost beyond dispute that a wide variety of infections, both viral and bacterial, can likely be as
causal, if not more, of GBS than the flu vaccine. Bielak v. Sec'y of Health & Hum. Servs., No. 18-
761V, 2023 WL 35509, at *30 (Fed. Cl. Spec. Mstr. Jan. 3, 2023) (noting that two thirds of GBS
cases follow an antecedent infection). Indeed, the same evidence offered in this case by Dr.
Steinman (unnecessarily, since the petition alleged a Table claim) to prove flu vaccine causation
expressly notes the causal capacity of infections. Ju at 166. This is actually the bedrock of many a
vaccine claim: if infection can be causal, the infection-like response vaccines elicit could logically
be causal as well. Given the above, plus the evidence specific to GBS and H. influenza offered in
this case, I easily find that this bacterial infection has been preponderantly shown to likely be
causal of GBS.
Second, the medical records also establish that Petitioner’s H. influenzae infection likely
“did cause” his GBS. Petitioner experienced a URI with a ten-day history of symptoms, with
treaters consistently deeming the infection as associated with his GBS, and it predated neurologic
symptoms onset. Dr. Steinman maintains that the lack of blood testing confirmation reduced the
likelihood of an infectious cause, but Dr. Collins, who is an expert in infectious diseases, has
persuasively explained that a positive blood culture is unnecessary to confirm the presence of an
H. influenza infection and in fact would not be expected unless the infection has spread to his
blood. Collins First Rep. at 11. More conclusive evidence comes from sputum findings, which
were positive, and the pneumonia diagnoses was further supported by chest X-ray findings and
other evidence of the infection. Ex. 1 at 27–28; 451. Treaters overwhelmingly associated his GBS
with this infection. Ex. 1 at 38, 49, 146, 154, 164, 174, 184, 200, 205, 226, 228–29, 257, 268, 316.
I find this evidence and assessment persuasive.
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Finally, the timeframe in which Petitioner’s GBS manifested after his likely infection was
medically acceptable. The medical records establish that the infection (which first manifested 10
days before Petitioner’s neurologic symptoms on December 10, 2017) occurred far closer in time
than vaccination—but within a timeframe that would be reasonable for an antibody-driven,
adaptive immune system autoimmune process to occur. See generally Randolph v. Sec'y of Health
& Hum. Servs., No. 15-146V, 2021 WL 5816271, at *23 (Fed. Cl. Spec. Mstr. Nov. 12, 2021)
(determining that a 12 day timeframe was medically acceptable period for how long it would take
a wild infectious process to result in an adaptive immune response).
The same record also adds heft to the conclusion that the vaccine could likely be excluded
as causal. As noted above, there is no record evidence of any close-in-time vaccine reaction.
Almost five weeks thereafter passed before Petitioner first sought treatment for his infectious
symptoms, which by this point were already ongoing. And then five more days elapsed before
Petitioner’s neurologic symptoms onset. This medical history is not consistent with the vaccine
playing even a contributory role to Petitioner’s GBS. And the mere fact that his onset fell into the
temporal period set for onset under a Table claim (albeit on one extreme end of that timeframe)
does not guarantee a vaccine “role,” right to the end. The facts of this case tell a different story,
and one that excludes the vaccine as likely causal in any way.16
Dr. Steinman argues that the very fact that the flu vaccine’s causality is reflected in the
existence of a Table claim somehow elevates the strength of reliability of the vaccine-injury
association—so much so that the vaccine almost has to be considered to have played some role in
Petitioner’s injury. Second Steinman Rep. at 1. But the Vaccine Act does not create a “pre-rebuttal”
context for factor unrelated circumstances, effectively preventing Respondent from ever excluding
a vaccine as a factor so long as the Table elements were met (as here). At most, the Table claim
only substantiates the idea that the flu vaccine “can cause” GBS. It does not prevent my
determinations that (a) infections can also cause GBS, (b) H. influenza can cause GBS, (c)
infections are more likely than vaccines to cause GBS, and (d) Petitioner’s medical history lends
strong support to the conclusion that the flu vaccine was not likely a factor in his GBS, whereas
the intervening infection was.
Because of the above, the record also does not support the conclusion that the flu vaccine
and H. influenza wild bacterial infection likely played dual roles in leading to Petitioner’s GBS,
with no expert truly able to differentiate them as causal. Certainly, there are cases where this is in
fact the final take-away from expert views, and in such circumstances a Shyface approach
mandates a determination for the Petitioner. Matten v. Sec'y of Health & Hum. Servs., No. 12-
155V, 2021 WL 5768148, at *42 (Fed. Cl. Spec. Mstr. Nov. 2, 2021) (determining that
16 I emphasize again: this determination is the result of the preponderance standard. I conclude it “more likely than
not” that the vaccine is excluded as causal. This of course leaves room for it being causal regardless, but the “fifty
percent and a feather” weighing standard did not favor Petitioner.
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Respondent’s expert could not completely reject the role of the flu vaccine resulting in K.M.’s
death instead of a parainfluenza virus, and thus finding that Respondent failed to satisfy his burden
in showing an alternative cause). In such a case, causation is shown even if the vaccine is not the
predominant factor causing illness; rather, it need only be demonstrated it was a substantial, “but
for” factor. Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352–53). A vaccine could
be causal of injury in association with another cause, even if neither can be identified as the more
likely sole or primary cause, and as already noted petitioners are never tasked with eliminating the
substantial factor in making their prima facie case.
But Dr. Collins did not concede that in this case she could not so distinguish the parallel
potential causal factors. Rather, this record—which showed the existence of an intervening
infection, closer in time to onset than the vaccine (received almost six weeks before onset), and
corroborated to be a kind of infection that has been associated with GBS—supported the infection
over the vaccine as the “but for” causal factor. And Dr. Steinman did not establish otherwise,
beyond making conclusory assertions favoring the vaccine over infection, while failing largely to
address the compelling record evidence that the Petitioner was likely experiencing a pre-GBS onset
sickness that could have been causal.
CONCLUSION
A Program entitlement award is only appropriate for claims supported by preponderant
evidence. Here, Petitioner has not made such a showing. Petitioner is therefore not entitled to
compensation.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.17
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
17 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.
25

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_20-vv-01319-1
Date issued/filed: 2023-12-12
Pages: 16
Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) of 46 Judge Vaccine Order/Opinion. Signed by Judge Thompson M. Dietz. (sbp) Service on parties made.
--------------------------------------------------------------------------------
Case 1:20-vv-01319-TMD Document 48 Filed 12/12/23 Page 1 of 16
In the United States Court of Federal Claims
No. 20-1319
(Filed Under Seal: November 21, 2023)
(Reissued: December 12, 2023)1
**************************************
RONALD E. WHITE, *
*
Petitioner, *
*
v. *
*
SECRETARY OF HEALTH AND HUMAN *
SERVICES, *
*
Respondent. *
**************************************
Lisa A. Roquemore, Law Office of Lisa A. Roquemore, Rancho Santa Margarita, CA, counsel
for Plaintiff.
Meghan R. Murphy, U.S. Department of Justice, Civil Division, Washington, DC, counsel for
Defendant.
OPINION AND ORDER
DIETZ, Judge.
Petitioner Ronald E. White (“White”) seeks review of Chief Special Master (“CSM”)
Brian Corcoran’s decision denying him compensation under the National Childhood Vaccine
Injury Act of 1986, 42 U.S.C. §§ 300aa-1 et seq. (“the Act”). White alleges that he was injured
by an influenza (“flu”) vaccine received on November 1, 2017. He sought compensation on
October 5, 2020. The CSM denied his request, concluding that although White showed that he
suffered from Guillain-Barré Syndrome (“GBS”), an injury listed on the vaccine injury table
(“the Table”), the government demonstrated that a Haemophilus influenzae (“H. influenzae” or
“H. influenza”) bacterial infection was more likely the sole substantial factor causing his GBS.
White contends that the CSM erred by making arbitrary and capricious findings of fact and by
failing to apply the correct burden of proof to the government. Because White has not
demonstrated that the CSM’s decision was arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law, the Court DENIES White’s motion and SUSTAINS the
CSM’s decision denying entitlement to compensation.
1
Pursuant to Vaccine Rule 18(b) of the Rules of the United States Court of Federal Claims, the Court issued this
Opinion and Order under seal on November 21, 2023, and provided the parties fourteen days to propose redactions.
See [ECF 46]. The parties did not propose any redactions. Accordingly, the Court reissues this Opinion and Order
without redactions.

Case 1:20-vv-01319-TMD Document 48 Filed 12/12/23 Page 2 of 16
I. BACKGROUND2
White was born on August 1, 1947. White, 2023 WL 4204568, at *1. As a child, he
suffered a polio infection that resulted in “chronic right lower extremity atrophy and weakness
for which he wore a brace on his right leg.” Id. On November 1, 2017, at the age of seventy,
White received a flu vaccine from his primary care physician, Dr. William Larsen. White, 2023
WL 4204568, at *1. Dr. Larsen, a doctor with Northwest Family Physicians, administered the
vaccine to White’s left deltoid. Id. At the time, Dr. Larsen noted White’s “post-polio stigmata.”
Id. (internal quotation marks omitted). Over one month later, on December 5, 2017, White
visited a CVS MinuteClinic “complaining of a non-productive cough, nasal congestion, runny
nose, and generalized fatigue that had lasted for two days.” Id. White “had a temperature of 99.6
degrees, and on exam displayed bilateral middle ear effusions, mucosal edema and rhinorrhea, an
irritated throat, and decreased breath sounds in his right middle lung field.” Id. “The nurse
practitioner [at the clinic] diagnosed him with a viral infection and prescribed benzonatate, a
non-narcotic cough suppressant.” Id.
Five days later, on December 10, 2017, White went to Atrium Health Harrisburg
Emergency Department (“ED”) complaining of a “generalized weakness” that started
“approximately ten hours earlier that same day.” White, 2023 WL 4204568, at *2. He also
complained of “ongoing [upper respiratory infection (“URI”)] symptoms,” that started ten days
before “but had not improved.” Id. White complained of a fever that had begun “several days”
prior to the ED visit, as well as “cough, wheezing, and congestion.” Id. He indicated that
although he had been taking “over-the-counter medications,” he had “recently begun to
experience increased weakness in his legs, and difficulty walking earlier that day that led to a
fall.” Id. At the time, White had a temperature of 97.9 degrees. Id.
While at the ED, White “displayed +2/5 motor strength in all extremities, and the
physician could not elicit patellar reflexes.” White, 2023 WL 4204568, at *2. “A head CT
showed no acute findings, [his] chest X-ray was normal,” and his “lab work revealed an elevated
white blood cell count of 12.9, with elevated absolute neutrophils of 9.7.” Id. The ED physician
was concerned that White may have GBS and therefore ordered that he “be transferred to a
facility that had plasmapheresis capabilities.” Id. White’s treaters “continued to report [his]
concurrent URI symptoms, noting that he likely was experiencing a viral illness.” Id.
Later that day, White’s doctors transferred him to Carolinas Medical Center’s intensive
care unit (“ICU”) “for further evaluation and treatment, and . . . for close monitoring of his
respiratory status.” White, 2023 WL 4204568, at *2. Because of “the rapid progression of his
ascending paralysis,” White’s doctors were concerned “that he might have an underlying
structural abnormality, but MRI imaging of his brain and cervical spine did not confirm the
existence of such issues.” Id. Further, his “lumbar puncture [] did not show an elevated protein
level.” Id. However, because White’s doctors suspected that he had GBS based on “his clinical
presentation,” he “was therefore started on plasmapheresis.” Id. Although White’s cerebrospinal
fluid tested negative for the presence of the herpes simplex virus, many of his “treating
physicians opined or speculated that his neurologic, GBS-like symptoms were associated with
2 The factual background is derived from the CSM’s decision. See White v. Sec’y of Health & Hum. Servs., 2023
WL 4204568 (Fed. Cl. June 2, 2023).
2

Case 1:20-vv-01319-TMD Document 48 Filed 12/12/23 Page 3 of 16
his preceding/ongoing respiratory infection.” Id. Also, even though White “initially respond[ed]
well to plasmapheresis treatment, [his] neurological condition continued to worsen, and he was
intubated on December 13, 2017.” Id. at *3. Thereafter, “[h]e was areflexic and had +1 motor
strength in all extremities.” Id. On December 14, 2017, White tested positive for “an H.
influenzae infection.”3 Id. Although his blood cultures tested negative for the presence of
bacteria, “[h]e had worsening chest X-ray findings in both his lungs.” Id. White’s doctors
therefore gave him antibiotics intravenously for seven days and inserted a tracheostomy. Id.
On December 20, 2017, White’s doctors transferred him from the ICU to a different unit
at Carolinas Medical Center so that he could be weaned off the ventilator. White, 2023 WL
4204568, at *3. “His course was complicated by an ileus and two acute episodes of urinary
retention.” Id. White’s doctors then tested him for GBS mimics including “arsenic poisoning,
Lyme disease, HSV, neurosyphilis, and B1 deficiency.” Id. “[N]one [of these GBS mimics] were
deemed the cause of [his] condition.” Id. During his hospitalization and following his release,
however, his treaters “continued to repeat the hospital summary that [he] likely had experienced
H. influenza pneumonia.” Id. While hospitalized, White received seven plasmapheresis
sessions.4 Id. “Upon discharge, [his] differential diagnosis included GBS and H. influenzae
pneumonia.” Id.
After being discharged from the hospital, White’s doctors transferred him to Clear Creak
Nursing and Rehab Center, a “long-term acute care hospital,” where his condition “continued to
improve.” White, 2023 WL 4204568, at *3. On January 24, 2018, White’s doctors transferred
him to Carolinas Rehabilitation Northeast, an inpatient rehabilitation facility. Although his health
continued to improve there, White “remained dependent on assistance with all movement,
requiring a wheelchair for ambulation and complete assistance with transfers to and from the bed
and bathroom.” Id. As of February 16, 2018, White was still unable to care for himself, and his
doctors transferred him “to a skilled care facility” for additional treatment. Id. “Records from this
time revealed mention of his prior receipt of the flu vaccine, although they do not also include
treater specification of a GBS-vaccine association.” Id.
White’s doctors discharged him for the last time in May 2018, after White spent three
months at another rehabilitation facility. White, 2023 WL 4204568, at *3. White still “required a
wheelchair, hospital bed, Hoyer lift, and bedside commode for home use.” Id. He received
physical and occupational therapy at home “[t]hrough the early fall of 2018.” Id. On May 28,
2018, during one of his initial home visits, White was “diagnosed with GBS after having a flu
shot and about a week and a half of cold symptoms, which was associated with weakness and an
overall decline in functional status.” Id. (internal quotation marks omitted). Eight months later, in
December of 2018, White saw his primary care physician, Dr. Catherine Norton, for an annual
physical exam. Id. at *4. Dr. Norton noted that White was still wearing a brace on his right leg
for “post-polio syndrome” and that he continued to suffer “sequelae from GBS (which the record
states he developed after a flu vaccine two years prior). Id.
3 A culture from a sputum sample from White’s lungs revealed the presence of the infection. White, 2023 WL
4204568, at *3.
4 He received the last session on December 21, 2017. White, 2023 WL 4204568, at *3.
3

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On March 25, 2019, White returned to Northwest Family Physicians with “a productive
cough and was diagnosed with bronchitis.” White, 2023 WL 4204568, at *4. At the time, he was
unable “to stand on his own for longer than a few seconds and required a hospital bed for a
change in position, ability to prevent decubitus ulceration, and facilitate getting in and out of bed
for adequate sleep.” Id. He also required “a wheelchair for ambulation.” Id. Five months later, in
August of 2019, White had a heart attack. Id. He was admitted to Carolinas Medical Center from
August 13 to September 5 and “underwent a coronary bypass surgery.” Id. After surgery, White
experienced “worsened left upper extremity weakness” and his doctors therefore referred him for
a neurology consultation “due to concern for post-operative stroke.” Id. Neurologist Dr. Paul
Weaver examined White and noted that he had “+5/5 bilateral upper extremity and left lower
extremity motor strength and +4/5 right lower extremity strength.” Id. Dr. Weaver further noted
that White “had a history of GBS secondary to H. influenza.” Id. (internal quotation marks
omitted). White underwent a head CT, which was “negative for acute findings.” Id. Further,
there were “no findings significant for an acute stroke, nor did [White] have worsened deficits.”
Id. Dr. Weaver recommended that White begin to wean off narcotics and engage in rehabilitation
to rebuild his strength. Id.
In September of 2019, cardiologist Dr. Kiran Venkatesh examined White. White, 2023
WL 4204568, at *4. Dr. Venkatesh did not document any “musculoskeletal complaints.” Id.
Thereafter, from October 24 through December 17, 2019, White received occupational and
physical therapy services at home through Bayada Home Health Care. Id. In 2020, Dr. Peter
Nguyen, a doctor with Harrisburg Family Physicians, began treating White for diabetes. Id. It is
unclear “from these later records” whether White continued to suffer from GBS at this time. Id.
On October 5, 2020, White sought compensation under the Act. See Pet. for
Compensation [ECF 1]. He alleged that he contracted GBS from the flu vaccine. Id. at 1-5.5
Although the CSM found that White “met his prima facie burden of proof for a table flu vaccine
GBS claim,” he also found that the government successfully showed that White’s condition was
caused by a factor unrelated to the vaccine—“an intercurrent H. influenza infection.” White,
2023 WL 4204568, at *15. Therefore, on June 2, 2023, the CSM denied White’s request for
compensation. Id. at *19. White sought review of the CSM’s decision on June 27, 2023. [ECF
36]. The government responded, [ECF 41], and White requested leave to file a reply, [ECF 42].
The Court allowed each party to file a reply, see [ECF 43]; however, only the petitioner did so,
[ECF 42-1]. The motion is fully briefed, and the Court held oral argument on November 17,
2023. See [ECF 44].
II. STANDARD OF REVIEW
This Court has jurisdiction under the Act to review a special master’s decision. 42 U.S.C.
§ 300aa-12(e)(2). In reviewing a special master’s decision, this Court may:
(A) uphold the findings of fact and conclusions of law of the special
master and sustain the special master’s decision, (B) set aside any of
the findings of fact or conclusions of law of the special master found
5 All page numbers in the petition for compensation and the parties’ briefings refer to the page numbers generated by
the CM/ECF system.
4

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to be arbitrary, capricious, and abuse of discretion, or otherwise not
in accordance with law and issue its own findings of fact and
conclusions of law, or (C) remand the petition to the special master
for further action in accordance with the court’s direction.
42 U.S.C. § 300aa-12(e)(2)(A)-(C).
This Court reviews a special master’s findings of fact 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. Turner v. Sec’y of Health & Hum.
Servs., 268 F.3d 1334, 1337 (Fed. Cir. 2001). With respect to the arbitrary and capricious
standard, “no uniform definition . . . has emerged,” but it is “a highly deferential standard of
review” such that “[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 v. Sec’y of Health & Hum. Servs., 940 F.2d 1518,
1527-28 (Fed. Cir. 1991); accord Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut.
Auto Ins. Co., 463 U.S. 29, 43 (1983) (a decision is arbitrary and capricious only if it is “so
implausible that it could not be ascribed to a difference of view”). The “not in accordance with
law” standard, on the other hand, is applied without deference to legal determinations such as
“[w]hether the special master applied the appropriate standard of causation . . . .” Deribeaux ex
rel. Deribeaux v. Sec’y of Health & Hum. Servs., 717 F.3d 1363, 1366 (Fed. Cir. 2013). Lastly,
the abuse of discretion standard applies to the special master’s evidentiary rulings, such as
determinations regarding the qualification of experts and the admissibility of their testimony.
Piscopo v. Sec’y of Health & Hum. Servs., 66 Fed. Cl. 49, 53 (2005) (citing Kumho Tire Co. v.
Carmichael, 526 U.S. 137, 152 (1999)). “The [abuse of discretion standard] will rarely come into
play except where the special master excludes evidence.” Munn v. Sec’y of Health & Hum.
Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992); accord Caves v. Sec’y of Health & Hum. Servs.,
100 Fed. Cl. 119, 131 (2011), aff’d, 463 F. App’x 932 (Fed. Cir. 2012).
The Federal Circuit has made clear that special masters, as the finders of fact, have the
responsibility to weigh the persuasiveness and reliability of evidence presented to them, and if
appropriate, the credibility of testimony. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d
1315, 1325 (Fed. Cir. 2010); see Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316
(Fed. Cir. 1999) (“[T]he rules of evidence require that the trial judge determine whether the
testimony has a reliable basis in the knowledge and experience of [the relevant] discipline.”)
(internal quotation marks omitted). The special master has broad discretion in determining the
credibility of witnesses and weighing the evidence, and these credibility determinations are
“virtually unreviewable” by the reviewing court. Bradley v. Sec’y of Health & Hum. Servs., 991
F.2d 1570, 1575 (Fed. Cir. 1993). In other words, the reviewing court does not reweigh the
evidence, assess whether the special master correctly evaluated the evidence, or examine the
probative value of the evidence or the credibility of the witnesses because all of these matters are
within the purview of the factfinder. Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d
1339, 1349 (Fed. Cir. 2010); accord Loyd, Next Friend of C.L. v. Sec’y of Health & Hum. Servs.,
2023 WL 1878572, at *2 (Fed. Cir. Feb. 10, 2023).
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III. LEGAL STANDARDS
The Act was established to compensate individuals for a vaccine-related injury or death
after a showing that the vaccine caused that injury or death. 42 U.S.C. § 300aa-11(a)(5)(B)(10).
The Act provides two ways for a petitioner to establish causation. Munn, 970 F.2d at 865. First, a
petitioner may demonstrate causation through a statutorily prescribed presumption by showing
that the alleged injury meets the criteria listed on the Table. 42 U.S.C. § 300aa-14. Thus, “if a
petitioner can establish that [he] received a listed vaccine and experienced such symptoms or
injuries within the specified timeframes, [he] has met [his] prima facie burden to prove that the
vaccine caused [his] injuries.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1351
(Fed. Cir. 2008). Alternatively, if a petitioner suffered an injury listed on the Table but not within
the specified time period or if a petitioner suffered an “off-Table injury,” he must prove
“causation-in-fact” by a preponderance of the evidence.6 See 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii);
see also Broekelschen, 618 F.3d at 1341-42. “Causation-in-fact in the Vaccine Act context is the
same as ‘legal cause’ in the general torts context.” de Bazan, 539 F.3d at 1351. Thus, “the
vaccine is a cause-in[-]fact when it is ‘a substantial factor in bringing about the harm.’” Id.
(quoting Restatement (Second) of Torts § 431(a)).
In Althen, the Federal Circuit stated a three-part test for showing causation in fact. It
requires the following:
[A petitioner must] show by a preponderance of the evidence that
the vaccination brought about the 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.
Althen, 418 F.3d at 1278. Before applying the Althen test, however, the Court must determine
whether a petitioner has shown by preponderant evidence a “medically recognized injury” that is
“more than just a symptom or manifestation of an unknown injury.” Lombardi v. Sec’y of Health
& Hum. Servs., 656 F.3d 1343, 1352-53 (Fed. Cir. 2011) (explaining that “if the existence and
nature of the injury itself is in dispute,” then “identification of a petitioner’s injury is a
prerequisite to an Althen analysis of causation”).
“Once the petitioner has established a prima facie case for entitlement to compensation
and thus met [his] burden to prove causation-in-fact, the burden shifts to the government to prove
“[by] a preponderance of the evidence that the [petitioner’s injury] is due to factors unrelated to
the administration of the vaccine described in the petition.” de Bazan, 539 F.3d at 1352 (quoting
42 U.S.C. § 300aa-13(a)(1)(B)). Under the Act, “factors unrelated to the administration of the
vaccine” may include “infection, toxins, trauma (including birth trauma and related anoxia), or
metabolic disturbances which have no known relation to the vaccine involved, but which in the
particular case are shown to have been the agent or agents principally responsible for causing the
6 “This court has interpreted the ‘preponderance of the evidence’ standard referred to in the Vaccine Act as one of
proof by a simple preponderance, of ‘more probable than not’ causation.” Althen v. Sec’y of Health & Hum. Servs.,
418 F.3d 1274, 1279 (Fed. Cir. 2005).
6

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petitioner’s illness, disability, injury, condition, or death.” 42 U.S.C.A. § 300aa-13(a)(2)(B).
Significantly, while a petitioner need only demonstrate that the vaccine was a substantial factor
in bringing about the alleged harm, the government must demonstrate that an unrelated factor
“was the sole substantial factor in bringing about the injury.” de Bazan, 539 F.3d at 1354
(emphasis added). In addition, the government’s proof of alternative actual causation in fact must
satisfy the same standard as the petitioner’s proof of actual causation in fact in off-table cases.
Deribeaux, 717 F.3d at 1368 (citing Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 549
(Fed. Cir. 1994)). However, if the Court finds that the government failed to prove alternative
actual causation in fact, the petitioner is entitled to compensation. de Bazan, 539 F.3d at 1352. If
the Court finds the parties’ evidence to be in equipoise, the petitioner is still entitled to
compensation. Heinzelman v. Sec’y of Health & Hum. Servs., 2008 WL 5479123, at *19 (Fed.
Cl. Dec. 11, 2008) (citing Knudsen, 35 F.3d at 550).
IV. ANALYSIS
White challenges the CSM’s finding that his H. influenza infection preceded the onset of
his GBS symptoms. Additionally, White asserts that the CSM improperly lowered the
evidentiary burden of proof under the first and third Althen prongs in reaching the conclusion
that the government satisfied its burden to show that White’s GBS was caused by H. influenzae,
a factor unrelated to the vaccine. For the reasons below, the Court concludes that White has not
shown that the CSM’s decision was arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with law.
A. Findings of Fact
White argues that the CSM’s finding that White suffered from an H. influenzae infection
prior to hospitalization was arbitrary and capricious. Mot. for Review [ECF 36] at 45. White
contends that although his medical records contain numerous references to the presence of cold
and URI symptoms prior to his hospitalization, the records also document the lack of symptoms
commonly associated with a cold or URI. Id. at 43-44. White further contends that the first
indication of H. influenza appears on his medical record from December 17, 2017—after his
hospitalization, that his H. influenza cultures were conducted after his hospitalization, and that
“[t]he medical records seem to indicate that the H. influenza occurred during the hospital stay.”
Id. (emphasis in original). White complains that “[t]he CSM minimized all of this relevant
evidence in order to find that [White], more likely, did have an ongoing H. influenza process in
advance of the onset of the GBS.” Id. at 45.
The Court concludes that the CSM’s finding that White suffered from a H. influenzae
infection prior to being hospitalized was rationally based upon the record evidence before him
because it came from White’s own statements about his condition, the notes of the various
practitioners who treated White, and from White’s medical test results.
The CSM describes White’s condition when he went to the CVS clinic on December 5,
2017, as follows:
7

Case 1:20-vv-01319-TMD Document 48 Filed 12/12/23 Page 8 of 16
[He was] complaining of a non-productive cough, nasal congestion,
runny nose, and generalized fatigue that had lasted for two days . . .
had a temperature of 99.6 degrees, and on exam displayed bilateral
middle ear effusions, mucosal edema and rhinorrhea, an irritated
throat, and decreased breath sounds in his right middle lung field.
White, 2023 WL 4204568, at *1 (citing [ECF 6-5] at 3-5 (12/5/2017 clinic notes taken by Nurse
Practitioner Anita Vaughan)).
Next, the CSM stated that when White was admitted to the ED five days later, he
complained “of generalized weakness that he reported had begun approximately ten hours earlier
that same day. . . . [and] also noted ongoing URI symptoms that he said had begun ten days prior
but had not improved.” White, 2023 WL 4204568, at *2 (citing [ECF 6-7] at 143-45 (12/10/2017
ED notes taken by Dr. Patrick Lynch)). The CSM added that White “stated that he had a fever
several days ago, cough, wheezing, and congestion, and was self-treating with over-the counter
medications and prescriptions. . . . [and that h]e had a temperature of 97.9 degrees . . . .” White,
2023 WL 4204568, at *2 (citing [ECF 6-7] at 143-44 (12/10/2017 ED notes taken by Dr. Patrick
Lynch); id. at 196 (12/10/2017 ED notes taken by Registered Nurse Emily K. Alexander)).
Further, the CSM stated:
Upon examination, [White] displayed +2/5 motor strength in all
extremities, and the physician could not elicit patellar reflexes. . . .
A head CT showed no acute findings, and [White’s] chest X-ray was
normal. . . . [White’s] lab work revealed an elevated white blood cell
count of 12.9, with elevated absolute neutrophils of 9.7. . . . Based
upon these findings, the [treating] physician expressed concern
about the possibility of GBS, and therefore ordered [White] to be
transferred to a facility that had plasmapheresis capabilities.
White, 2023 WL 4204568, at *2 (citing [ECF 6-7] at 144-48 (12/10/2017 ED notes taken by Dr.
Patrick Lynch); id. at 179 (12/10/2017 ED test results); [ECF 6-1] at 338 (same)). The CSM also
stated that “treaters continued to report [White’s] concurrent URI symptoms, noting that he
likely was experiencing a viral illness,” White, 2023 WL 4204568, at *2.7 The CSM continued:
“[T]hroughout [White’s] hospitalization and even after his discharge, there were numerous
7 The CSM cited [ECF 6-1] at 38 (12/11/2017 ICU notes taken by Dr. Sara Skavroneck); id. at 49 (12/20/2017 ICU
notes taken by Dr. Sailaja Allamneni); id. at 146 (ICU notes taken by Dr. Robert M. Lombard, Jr.); id. at 154
(ICU test results and notes taken by Certified Physician’s Assistant Alexandra Stewart); id. at 164 (12/22/2017 ICU
notes taken by Dr. Allamneni); id. at 174 (12/21/2017 notes taken by Dr. Rahul Karamchandani and ICU test
results); id. at 184 (12/21/2017 ICU notes taken by Dr. Allamneni); id. at 200 (ICU notes taken by Dr. Kwon and
test results); id. at 205 (ICU notes taken by Dr. Rebecca E. Burkhart); id. at 226 (12/18/2017 ICU notes taken by Dr.
Karamchandani and test results); id. at 228-29 (12/18/2017 ICU notes taken by Dr. Arina Ghaffari, ICU notes taken
by Dr. Burkhart); id. at 257 (12/16/2017 ICU notes taken by Dr. Douglas W. Haden); id. at 268 (ICU notes taken by
Dr. Scott Crane); and id. at 316 (ICU notes taken by Dr. Luke A. Neilans).
8

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occasions where treaters continued to repeat the hospital summary that [he] likely had
experienced H. influenza pneumonia.” Id. at *3 (emphasis added).8
In sum, the CSM’s decision shows that he considered the relevant record evidence, drew
plausible inferences, and articulated a rational basis in reaching the conclusion that White’s H.
influenza infection preceded the onset of his GBS symptoms. The Court will not second guess
his factual findings. See Munn v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863, 871
(Fed. Cir. 1992) (“[I]t is not then the role of this court to reweigh the factual evidence, or to
assess whether the special master correctly evaluated the evidence. . . . [W]e do 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.”).9
B. Legal Conclusions
White disputes the CSM’s analysis under two of the three Althen prongs. Specifically,
White contends that the CSM improperly held that the government satisfied the first and third
Althen prongs and therefore erroneously concluded that the government proved that White’s
GBS was in fact caused by H. influenzae. The Court begins its review of the CSM’s analysis
with an overview of the expert witness reports in evidence.
1. Expert Witness Reports
White’s expert witness, Dr. Lawrence Steinman,10 opined that White’s GBS was caused
by his flu vaccine. [ECF 22-1] at 7. According to Dr. Steinman, components of the flu vaccine
White received “initiated an immune response that cross-reacted by molecular mimicry to two
antigens that are known to be targeted in GBS.” Id. at 1. Specifically, he stated that “[t]he
components of the 2017-2018 influenza vaccine have molecular mimicry with myelin basic
8 The CSM cited [ECF 6-1] at 50 (12/20/2017 ICU notes taken by Dr. Allamneni); id. at 83 (12/28/2017 ICU notes
taken by Dr. Allamneni); id. at 90 (12/27/2017 ICU notes taken by Dr. Allamneni); id. at 102 (12/26/2017 ICU notes
taken by Dr. Allamneni); id. at 111 (ICU notes taken by Dr. Robert M. Lombard, Jr.); id. at 123 (ICU notes taken by
Dr. Lombard); id. at 146 (ICU notes taken by Dr. Lombard); id. at 165 (12/22/2017 ICU notes taken by Dr.
Allamneni); id. at 185 (12/21/2017 ICU notes taken by Dr. Allamneni); and id. at 200 (ICU notes taken by Dr. Matt
Hyoung Jin Kwon).
9 Further, although not included by the CSM in the “Fact History” section of his opinion, the Court notes that the
CSM was persuaded by the government expert’s assessment of White’s test results:
Dr. Collins, who is an expert in infectious diseases, has persuasively explained
that a positive blood culture is unnecessary to confirm the presence of an H.
influenza infection and in fact would not be expected unless the infection has
spread to his blood. . . . More conclusive evidence comes from sputum findings,
which were positive, and the pneumonia diagnoses was further supported by chest
X-ray findings and other evidence of the infection.
White, 2023 WL 4204568, at *17. Thus, the CSM’s conclusion that White contracted an H. Influenzae infection
prior to contracting GBS was also rationally based on an expert’s assessment of White’s condition.
10 Dr. Steinman, who is board-certified in neurology, teaches and sees patients at Stanford University. Dr.
Steinman’s First Expert Report [ECF 22-1] at 2.
9

Case 1:20-vv-01319-TMD Document 48 Filed 12/12/23 Page 10 of 16
protein and with contactin-1.” Id. Dr. Steinman defined molecular mimicry as follows:
[It is] an evolutionary adaptation whereby viruses and bacteria
attempt to fool the body into granting them free access. Such
mimicry works by showing the immune system stretches of amino
acids that look like self. For example, adenovirus type 2 has amino
acid sequences like those in the crucial fragment of myelin basic
protein. In responding routinely to this virus, the immune system
may become primed to attack the corresponding self-component—
myelin.
Id. at 10 (quoting L. Steinman, Autoimmune Disease, 269 SCIENTIFIC AMERICAN 106, 106-114
(1993)). Significantly, although Dr. Steinman held fast to his belief that White’s GBS was
caused by the flu vaccine, he conceded that “in rare circumstances H. influenza infection is
associated with GBS.” Id. at 9. In his view, however, it was unclear from the record whether
White had an H. influenzae infection prior to getting GBS. Id.
The government’s expert witness, Dr. Collins,11 reached a different conclusion. She
found that White’s GBS was not caused by the vaccine but was instead more likely the result of
an ongoing H. influenzae infection in his lungs. [ECF 25-1] at 3, 5. She stated: “Based on the
exhibits and a review of the current literature, it is more likely than not that the influenza
vaccination administered to [White] on November 1, 2017, did not cause his [GBS].” Id. at 6.
After briefly discussing six studies,12 she further concluded that “[t]he risk of [GBS] following
the receipt of the influenza vaccine is significantly less than that following acute respiratory
infection.” Id.
Next, Dr. Collins considered the relationship between various infections and GBS. [ECF
25-1] at 8-10. Regarding the association between infections causing “acute respiratory
infections” and GBS, she cited a 2007 study of 500 GBS cases taken from a United Kingdom
database. Id. at 10.13 About the Tam study, Dr. Collins noted the following:
11 Dr. Kathleen L. Collins, who is board-certified in infectious disease, teaches at the University of Michigan, and
has a clinical practice. Dr. Collins’ First Expert Report [ECF 25-1] at 1.
12 Dr. Collins cited: (1) [ECF 25-6] (J. Stowe et al., Investigation of the Temporal Association of Guillain-Barré
Syndrome with Influenza Vaccine and Influenza like Illness Using the United Kingdom General Practice Research
Database, 169 AM. J. EPIDEMIOLOGY 382, 385-86 (2008)) (“Stowe”); (2) [ECF 25-7] L. Grimaldi-Bensouda et al.,
Guillain-Barré Syndrome, Influenza like Illnesses, and Influenza Vaccination During Seasons with and Without
Circulating A/H1N1 Viruses, 174 AM. J. EPIDEMIOLOGY 326, 326 (2011) (“Grimaldi-Bensouda”); (3) [ECF 25-8]
(S.K. Greene et al., Guillain-Barré Syndrome, Influenza Vaccination, and Antecedent Respiratory and
Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 8 PLoS One e67185 (2013));
(4) [ECF 25-9] (C. Vellozzi et al., Cumulative Risk of Guillain-Barré Syndrome Among Vaccinated and
Unvaccinated Populations During the 2009 H1N1 Influenza Pandemic, 104 AM. J. PUBLIC HEALTH 696, 696-701
(2014)); (5) [ECF 25-10] DeStefano et al., Principal Controversies in Vaccine Safety in the United States, 69 CLIN.
INFECT. DIS. 1, 4 (2019)) (“DeStefano”); and (6) [ECF 25-12] R. Baxter et al., Lack of Association of Guillain-Barré
Syndrome with Vaccinations, 57 CLIN. INFECT. DIS. 197-204 (2013)) (“Baxter”).
13 Dr. Collins cited [ECF 25-5] (C. Tam et al., Guillain-Barré Syndrome and Preceding Infection with
Campylobacter, Influenza and Epstein-Barr Virus in the General Practice Research Database, 2 PLoS One 1, 5
(2007)) (“Tam”).
10

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[T]the investigators found positive associations between [GBS] and
a variety of infections including “acute respiratory infections” in the
previous two months. Presumably due to prevention of influenza
virus infection, the authors also found what appeared to be a
protective effect of influenza vaccination . . . . In sum, these studies
support the conclusion that infection rather than influenza
vaccination is a risk factor for the development of [GBS].
[ECF 25-1] at 10. She then stated, citing a 2012 study of the relationship between GBS and a
recent H. influenzae infection in thirty-five hospitalized Iranian patients, that “[t]here is
substantial evidence that [H. influenzae], which was cultured from Mr. White’s lungs on
December 14, 2017, is one of the pathogens causing acute respiratory infections that increase
risk for the development of [GBS].” Id.14 Dr. Collins concluded:
Based on the exhibits provided, and a thorough review of modern
literature, there is strong evidence that infection, including acute
respiratory infection, increases the risk of [GBS]. Mr. White
experienced an acute respiratory infection with a ten-day history of
symptoms prior to the development of his neurological symptoms.
He had an elevated white blood cell count, an abnormal chest x-ray
and infection by a bacterial pathogen ([H. influenza]) that causes
respiratory infections and has been associated with [GBS]. In
contrast, there is a strong and growing body of evidence that
influenza vaccination is unlikely to increase risk of acquiring [GBS].
Id.
2. Althen Prong One
White argues that the CSM failed to mandate that the government satisfy its burden of
proof under the first Althen prong by providing preponderant evidence of the biological
mechanism by which H. influenzae could cause GBS. [ECF 36] at 25, 28. White states:
If this is the standard to show “factor unrelated” without meeting all
of the Althen prongs, then the higher burden pursuant to Federal
Circuit decisions, has no meaning. Boiled down to its essence, the
standard as articulated in the Decision, will simply be met with
nothing more than literature and an expert concluding that the
alternative has more risk of causing the GBS than the vaccine, which
is in most cases.
14 Dr. Collins cited [ECF 25-22] (S. Nafissi et al., The Role of Cytomegalovirus, Haemophilus Influenzae and
Epstein Barr Virus in Guillain Barre Syndrome, 51 ACTA MEDICA IRANICA 372, 375 (2013)) (“Nafissi”).
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Id. at 28-29. White further avers: “Indeed, in addition to no explanation, no immunologist was
proffered to address the issue. Nor, did respondent eliminate the vaccine as a substantial cause as
required.” Id. at 30.
Under the first Althen prong, the government must provide a medical theory causally
connecting the factor unrelated to the flu vaccine and White’s injury. In other words, the
government must provide a medical theory causally connecting White’s H. influenzae infection
and his GBS. Although the government “must provide a reputable medical or scientific
explanation that pertains specifically to [its] case,” the explanation does not need to be
“medically or scientifically certain.” Broekelschen, 618 F.3d at 1345. It only needs to be “legally
probable.” Id. (quoting Knudsen, 35 F.3d at 548-49) (internal quotation marks omitted).
Moreover, “conclusive evidence in the medical literature” is not required. Andreu v. Sec’y of
HHS, 569 F.3d 1367, 1378 (Fed. Cir. 2009); see also id. at 1379 (“[A] paucity of medical
literature supporting a particular theory of causation cannot serve as a bar to recovery.”).
Here, the CSM evaluated and weighed the evidence to reach the conclusion that the
government satisfied the first Althen prong. See White, 2023 WL 4204568, at *1, 17. He
determined that a factor unrelated to the vaccine—an H. influenzae infection—was more likely
the sole substantial cause of White’s GBS. Id. The CSM appropriately based his determination
on the medical literature,15 the reports of the parties’ expert witnesses, and his own experience as
a special master. See Saxton By & Through Saxton v. Sec’y of Dep’t of Health & Hum. Servs., 3
F.3d 1517, 1521 (Fed. Cir. 1993) (“Vaccine program special masters are also entitled to use their
prior experience in reviewing fee applications.”).
In support of his contention that “there is reliable evidence in the medical literature
demonstrating an association between the risk of GBS following infection generally,” the CSM
credited Dr. Collins’ expert reports. White, 2023 WL 4204568, at *17. First, in his overview of
the parties’ expert reports, the CSM noted that although Dr. Collins “acknowledged that GBS
attributable to the flu vaccine . . . is an accepted Vaccine Injury Table claim,” she then found that
“numerous studies have examined the risk of GBS following receipt of the vaccine, with results
demonstrating that the risk is significantly less than that following an acute respiratory
infection.” Id. at *6. Next, the CSM noted that “[o]ther evidence of the infection/GBS
association was referenced by Dr. Collins and deemed equally reliable and persuasive.” Id. In his
analysis, the CSM cited five medical papers proffered by Dr. Collins. The CSM cited: (1) Tam;
(2) [ECF 25-16] (P. van Doorn et al, Clinical Features, Pathogenesis, and Treatment of Guillain-
Barre Syndrome, 7 LANCET 939, 941 (2008)) (“van Doorn”);16 (3) [ECF 25-20] (Y.Y. Ju et al.,
Haemophilus Influenzae as a Possible Cause of Guillain-Barré Syndrome, 149 J.
NEUROIMMUNOLOGY 160, 160 (2004)) (“Ju”); (4) [ECF 25-21] (M. Mori et al., Haemophilus
Influenzae Infection and Guillain-Barré Syndrome, 123 BRAIN 2171, 2171 (2000)) (“Mori”); and
15 Regarding his approach towards medical literature, the CSM explained that while he considered all the medical
and scientific literature before him, he only referenced those articles relevant to his determination and/or central to
White’s case. White, 2023 WL 4204568, at *14.
16 The CSM mistakenly refers to van Doorn as “van Doom.” Compare White, 2023 WL 4204568, at *17 with [ECF
25-16] at 1.
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(5) Nafissi. Each of these studies supports the CSM’s finding of an association between infection
generally and GBS.17
Next, the CSM observed that “[s]ome of the evidence is in fact specific to H. influenza
infection.” White, 2023 WL 4204568, at *17. In support of this contention, the CSM cited Ju,18
one of the studies Dr. Collins credited in her expert report. See [ECF 25-1] at 10. Additionally,
the CSM observed that White’s expert, Dr. Steinman, “himself agreed to this association, even if
he downplayed it a bit.” White, 2023 WL 4204568, at *17 (citing [ECF 22-1] at 9). Further, the
CSM noted: “And though Dr. Steinman cites literature that also associates vaccination and GBS,
that risk is consistently deemed lesser in comparison (and in some studies unfounded).” White,
2023 WL 4204568, at *17 (emphasis in original). Here, the CSM cited DeStefano,19 another
study referenced by Dr. Collins. See [ECF 25-1] at 8 (“Influenza infection is a stronger risk
factor for GBS than is influenza vaccine; thus, during an entire influenza season, influenza
vaccination has been shown to actually decrease the risk of GBS by protecting against influenza
infection.”) (quoting DeStefano at 4) (internal quotation marks omitted). The CSM also noted,
citing two of the studies discussed at length by Dr. Collins,20 that “[i]t has even been documented
that vaccination might play a protective role against GBS.” White, 2023 WL 4204568, at *17
(citing Stowe at 385-86, Grimaldi-Bensouda at 326).
Lastly, in response to White’s argument that the government’s proof of causation is
insufficient because it is based on “the contention that probabilities favor infection over vaccine,
without much scientific showing,” the CSM explained that “no one kind of evidence is needed to
prove any of the Althen prongs,” and that, in his experience, it is “almost beyond dispute that a
wide variety of infections, both viral and bacterial, can likely be as causal, if not more, of GBS
than the flu vaccine.” White, 2023 WL 4204568, at *17 (emphasis in original). The CSM added
that Dr. Steinman’s evidence regarding the causal connection between the flu vaccine and GBS
“expressly notes the causal capacity of infections.” Id. (citing Ju at 166) (emphasis in original).
The CSM stated: “This is actually the bedrock of many a vaccine claim: if infection can be
causal, the infection-like response vaccines elicit could logically be causal as well.” Id.
17 In Tam, the authors discuss a study of cases from a United Kingdom database between 1991 and 2001 for
associations between GBS and infection with, among other things, influenza-like illness (“ILI”) in the previous two
months. Tam at 1. The authors note “strong, positive associations between infection with . . . ILI and GBS risk,” as
well as “evidence for an 18-fold increased risk of GBS in the two months following ILI.” Id. at 5. In van Doorn, the
authors note that “[m]olecular mimicry and cross-reactive immune responses have also been identified after some
types of preceding infection, including H influenzae.” van Doorn at 3. In Ju, the authors discuss “the frequency of
infection as indicated by elevated antibody in GBS patients,” and conclude that “although GBS is rarely preceded by
H. influenzae in the UK, there is a probable rare association with certain strains of nonencapsulated H. influenzae.”
Ju at 6-7. In Mori, the authors “concluded that a form of [GBS] occurs after respiratory infection by H. influenzae in
the Japanese population.” Mori at 1. Lastly, in Nafissi, the authors studied the relationship between several
infections and GBS and found that “only Haemophilus influenzae infection appeared to be significantly related to
GBS.” Nafissi at 372.
18 White, 2023 WL 4204568, at *17 (citing Ju at 160).
19 White, 2023 WL 4204568, at *17 (citing DeStefano at 4).
20 See [ECF 25-1] at 6-7.
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In sum, as to the first Althen prong,21 the Court finds that the CSM’s finding that H.
influenzae was “preponderantly shown to likely be causal of GBS,” was appropriately based on
the evidence, which included both parties expert witness reports, the medical literature cited
therein, and the CSM’s own experience. His conclusion was in accordance with the law.
3. Althen Prong Three
White argues that the CSM improperly determined that the government satisfied its
burden of proof under the third Althen prong. [ECF 36] at 31. First, White contends that “the
CSM erroneously found that the GBS manifested after [White’s] likely infection was medically
acceptable i.e. 10 days before [his] neurologic symptoms on December 10, 2017.” Id. at 31-32
(emphasis in original). White states that, not only did the CSM incorrectly find that White’s GBS
weakness started ten rather than seven days after his head cold, but the CSM could not have
decided whether there was an appropriate temporal association between H. influenzae and GBS
because the government’s expert did not address the biological mechanism by which the
infection causes GBS. Id. at 32. Next, White avers that the CSM was overly reliant on the
literature referenced by the government’s expert in support of his conclusion that the risk of GBS
following an H. influenzae infection was greater than that following a flu vaccination. Id. at 34-
35. Finally, White argues that the CSM erroneously found that the government proved that the H.
influenzae infection was the sole and substantial cause of White’s GBS. Id. at 35-36.
Under the third Althen prong, the government must demonstrate by preponderant
evidence a proximate temporal relationship between a factor unrelated to the flu vaccine and
White’s injury. See Althen, 418 F.3d at 1278. In other words, the government must show a
proximate temporal relationship between White’s H. influenzae infection and his GBS. As noted
above, the government’s burden is higher than White’s because the government must
demonstrate that his H. influenzae infection was the sole substantial cause of his GBS. See de
Bazan, 539 F.3d at 1354.
Here, the CSM appropriately evaluated and weighed White’s medical records, the
caselaw, and parties’ expert witness reports to reach the conclusion that the government satisfied
the third Althen prong. First, in support of his conclusion that “the timeframe in which [White’s]
GBS manifested after his likely infection was medically acceptable,” the CSM stated: “The
medical records establish that the infection (which first manifested 10 days before Petitioner's
neurologic symptoms on December 10, 2017) occurred far closer in time than vaccination—but
21 Although White does not challenge the CSM’s conclusion under the second Althen prong, the Court notes that the
CSM appropriately evaluated and weighed the evidence to reach the conclusion that White’s “H. influenza infection
likely ‘did cause’ his GBS.” White, 2023 WL 4204568, at *17. First, the CSM noted that the medical records
showed that White “experienced a URI with a ten-day history of symptoms,” id., that White’s treaters consistently
associated his infection with GBS, and that White’s infection “predated neurologic symptoms onset,” id. Addressing
Dr. Steinman’s concern “that the lack of blood testing confirmation reduced the likelihood of an infectious cause,”
the CSM noted that he was persuaded by the explanation proffered by Dr. Collins, an expert in infectious diseases.
Id. According to the CSM, Dr. Collins “persuasively explained that a positive blood culture is unnecessary to
confirm the presence of an H. influenza infection and in fact would not be expected unless the infection has spread
to his blood.” Id. (citing [ECF 25-1] at 11). Further, the CSM noted that White’s sputum findings were positive for
infection and that his chest X-ray and other test results supported his pneumonia diagnosis. Id. (citing [ECF 6-1] at
27-28 (12/14/2017 ICU lab results)); id. (citing [ECF 6-1] at 451 (12/14/2017 ICU x-ray results)).
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within a timeframe that would be reasonable for an antibody-driven, adaptive immune system
autoimmune process to occur.”22 White, 2023 WL 4204568, at *18. The CSM then cited
Randolph v. Secretary of Health and Human Services, a decision wherein the Special Master
determined that a twelve-day timeframe was a medically accepted period for how long it would
take an infection to produce an adaptive immune response. Id. (citing 2021 WL 5816271, at *23
(Fed. Cl. Spec. Mstr. Nov. 12, 2021)). The CSM further credited White’s medical record as
adding “heft to the conclusion that the vaccine could likely be excluded as causal,” noting that
there was no evidence that White had a “close-in-time vaccine reaction,” that White didn’t seek
medical treatment for his infectious symptoms until five weeks later, and that White’s neurologic
symptoms manifested five days after he first sought treatment. White, 2023 WL 4204568, at *18.
The CSM also appropriately noted that the fact that White experienced symptoms within
the timeframe set forth in the Table is not ultimately dispositive as to causation. White, 2023 WL
4204568, at *18. See Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072, 1078 (Fed. Cir.
2020) (petitioners who assert on-Table claims are “afforded a presumption of causation”)
(emphasis added). Explaining his disagreement with Dr. Steinman’s contention “that the very
fact that the flu vaccine’s causality is reflected in the existence of a Table claim somehow
elevates the strength of reliability of the vaccine-injury association,” the CSM stated:
At most, the Table claim only substantiates the idea that the flu
vaccine “can cause” GBS. It does not prevent my determination that
(a) infections can also cause GBS, (b) H. influenza can cause GBS,
(c) infections are more likely than vaccines to cause GBS, and (d)
[White’s] medical history lends strong support to the conclusion that
the flu vaccine was not likely a factor in his GBS, whereas the
intervening infection was.
Id.
Notably, the CSM also addressed whether the evidence demonstrated that both the flu
vaccine and the H. influenzae infection caused White’s GBS. White, 2023 WL 4204568, at *18.
While acknowledging that, under Shyface, a petitioner may prevail if the government fails to
satisfy its burden by showing an alternative cause, the CSM found that the government made the
necessary showing in this case. Id. In so doing, the CSM not only credited Dr. Collins’
conclusion that the evidence supported a finding that White’s infection rather than his vaccine
was the “but for” cause of his GBS, but he also found that Dr. Steinman’s contrary assertions
were conclusory and failed “to address the compelling record evidence that [White] was likely
experiencing a pre-GBS onset sickness that could have been causal.” Id. at *19. In sum, as to the
third Althen prong, the Court finds that the CSM’s conclusion that H. influenzae was the sole
substantial cause of White’s GBS was in accordance with the law.
22 White’s medical records support the CSM’s finding that White experienced a URI ten days before he was
admitted to the ED on December 10, 2017. See [ECF 6-1] at 200 (ICU notes taken by Dr. Kwon noting that White
had a “bad URI 10 days prior to presentation”); id. at 205 (ICU notes taken by Dr. Burkhart noting that White
“presented to the emergency department with complaints of 10-day history of viral URI with onset of bilateral lower
extremity weakness on 12/10”).
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4. Weighing of the Evidence
In addition to arguing that the government failed to satisfy the first and third Althen
prongs, White also argues that the CSM improperly gave “considerable weight . . . to
Respondent’s expert’s literature and argument that the H. Influenza had more risk to cause
GBS,” whereas “the risk from vaccination was routinely deemed lesser.” [ECF 36] at 34. The
CSM did not, however, determine that the government had met its burden based on statistical
probabilities alone. Instead, the CSM found that the government met its burden because the
medical literature, the expert testimony, and the clinical records support the conclusion that
White’s H. influenzae infection was the sole substantial cause of his GBS and because the facts
in this case support the conclusion that the vaccine did not play a contributory role in White’s
GBS. The CSM explained:
The same record also adds heft to the conclusion that the vaccine
could likely be excluded as causal. As noted above, there is no
record evidence of any close-in-time vaccine reaction. Almost five
weeks thereafter passed before Petitioner first sought treatment for
his infectious symptoms, which by this point were already ongoing.
And then five more days elapsed before Petitioner's neurologic
symptoms onset. This medical history is not consistent with the
vaccine playing even a contributory role to Petitioner's GBS. And
the mere fact that his onset fell into the temporal period set for onset
under a Table claim (albeit on one extreme end of that timeframe)
does not guarantee a vaccine “role,” right to the end. The facts of
this case tell a different story, and one that excludes the vaccine as
likely causal in any way.
White, 2023 WL 4204568, at *18. The Court cannot conclude that the CSM’s weighing of the
evidence was not in accordance with the law.
V. CONCLUSION
White has not demonstrated that the CSM’s decision was arbitrary, capricious, an abuse
of discretion, or otherwise not in accordance with law. Therefore, this Court must sustain the
CSM’s decision. White’s motion for review of the CSM’s decision is DENIED, and the CSM’s
entitlement decision of June 2, 2023, is SUSTAINED. The Clerk of the Court is DIRECTED to
enter judgment accordingly.
IT IS SO ORDERED.
s/ Thompson M. Dietz
THOMPSON M. DIETZ, Judge
16