VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-00969
Package ID: USCOURTS-cofc-1_19-vv-00969
Petitioner: Colleen Block
Filed: 2019-07-03
Decided: 2021-12-02
Vaccine: influenza
Vaccination date: 2017-11-10
Condition: Guillain-Barré syndrome
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Colleen Block filed a petition alleging that she developed Guillain-Barré syndrome (GBS) as a result of an influenza vaccine she received on November 10, 2017. Her petition was initially considered as a potential Table claim, but the court determined that her symptoms began approximately 24 hours after vaccination, which falls outside the 3 to 42-day window for a Table flu/GBS injury. The case then proceeded as an off-Table claim, requiring Ms. Block to prove causation-in-fact. She relied on an expert report and literature suggesting a possible one-day onset for GBS after vaccination. However, the court found this evidence unpersuasive, particularly the cited Park article, which had diagnostic uncertainties and did not adequately address alternative causes like infection. The court gave less weight to Ms. Block's expert due to a lack of specific immunological background regarding the critical question of GBS onset timing. Respondent's experts argued that the adaptive immune response involved in GBS requires more time to manifest symptoms, making a one-day onset medically implausible. Ultimately, the court concluded that Ms. Block failed to establish by a preponderance of the evidence that a one-day onset of GBS after a flu vaccine is medically acceptable. Therefore, her off-Table claim was dismissed, and she was denied compensation.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_19-vv-00969-0
Date issued/filed: 2021-05-28
Pages: 13
Docket text: PUBLIC ORDER/RULING (Originally filed: 04/26/2021) regarding 25 Findings of Fact & Conclusions of Law, Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made.
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Case 1:19-vv-00969-UNJ Document 26 Filed 05/28/21 Page 1 of 13
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-969V
UNPUBLISHED
COLLEEN BLOCK, Chief Special Master Corcoran
Petitioner, Filed: April 26, 2021
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Table Dismissal; Onset; Influenza
HUMAN SERVICES, (Flu) Vaccine; Guillain-Barré
syndrome (GBS)
Respondent.
Lia Obata Dowd, Dowd & Dowd, P.C., St. Louis, MO, for Petitioner.
Jeremy Fugate, U.S. Department of Justice, Washington, DC, for Respondent.
FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CLAIM1
On July 3, 2019, Colleen Block filed a petition for compensation under the National
Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine
Act”). Petitioner alleged that she suffered Guillain-Barré syndrome (“GBS”) as a result of
an influenza (“flu”) vaccine administered on November 10, 2017. Petition at 1-2. The case
was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”).
On June 2, 2020, Petitioner was ordered to show cause why this case should not
be dismissed, because it appeared onset of her symptoms did not meet the Table’s
requirements. ECF No. 18. In reaction, Petitioner filed a brief and expert report on
1 Because this unpublished Ruling contains a reasoned explanation for the action in this case, I am required
to post it on the United States Court of Federal Claims' website in accordance with the E-Government Act
of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government
Services). This means the Ruling will be available to anyone with access to the internet. In accordance
with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information,
the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that
the identified material fits within this definition, I will redact such material from public access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).

Case 1:19-vv-00969-UNJ Document 26 Filed 05/28/21 Page 2 of 13
September 1, 2020. ECF Nos. 20-22 (collectively, “Br.”). Respondent filed a responsive
brief (“Opp.”) on October 30, 2020. ECF No. 24. For the reasons discussed below, the
Table version of Petitioner’s claim is hereby dismissed – but Petitioner has offered just
enough evidence to support a non-Table claim (although Respondent will be provided the
opportunity to offer his own expert and/or brief the dispositive timing issue that could result
in the Petition’s total dismissal).
I. Relevant Procedural History
As noted, the case was filed in the summer of 2019.3 ECF No. 1. On April 3, 2020,
Respondent filed a Rule 4(c) Report challenging Petitioner’s right to compensation. ECF
No. 16. Respondent initially questioned the validity of Petitioner’s GBS diagnosis, noting
that her records lacked evidence of neurological and other clinical findings consistent with
this condition.4 Res. Report at 10-11. But Respondent also argued that even if Petitioner
were found to have GBS, Petitioner’s claim would not be viable based on the most likely
date for onset of symptoms.5 Id. at 12-14. Petitioner’s medical records and affidavits
placed the onset of her GBS within 24 hours of vaccination – and thus outside the 3-42
day flu-GBS onset period set forth in the Vaccine Injury Table. Id. at 12. Moreover,
Respondent asserted that Petitioner had not otherwise shown that the timing of her
condition within one day of vaccination was medically acceptable to maintain even a
causation-in-fact claim. Id. at 12-14.
I held a status conference with the parties on June 2, 2020. During the call, I noted
that the record evidence appeared to establish onset of Petitioner’s symptoms within
approximately 24 hours of vaccination, as Respondent argued. ECF No. 18. Thus, a
Table claim could not succeed. I also, however, raised issues with a causation-in-fact
version of the claim, informing the parties I had in the past year dismissed such a claim
where onset of GBS symptoms was too close in time to vaccination to be medically
acceptable. See Rowan v. Sec'y of Health & Human Servs., No. 17-760V, 2020 WL
2954954 (Fed. Cl. Spec. Mstr. Apr. 28, 2020) (finding that GBS is known to be mediated
by autoantibodies produced via the adaptive immune system, and this process, if vaccine-
induced, likely takes longer than three days to result in symptoms). Despite the above, I
observed that Petitioner might still be able to produce evidence to establish a viable non-
Table flu-GBS claim. ECF No. 18.
3 Ms. Block later filed an Amended Petition on October 27, 2019 correcting citations used in the original
Petition. ECF No. 9.
4 Respondent additionally noted that a possible “functional (or conversion) disorder,” as documented in
Petitioner’s medical records, might explain her symptoms. Res. Report at 11-12.
5 Respondent also asserted that the records supported an alternative cause of Petitioner’s GBS –
specifically, a pre-vaccination history of diarrheal illness. Res. Report at 11.
2

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I therefore issued an Order to Show Cause following the status conference
directing Petitioner to file a response to Respondent’s Rule 4(c) Report explaining why
her claim – whether couched as a Table or causation-in-fact claim – should not be
dismissed. ECF No. 18. Petitioner was additionally authorized to obtain an expert report
in connection with her response. Id. Following the parties’ submissions, I would determine
whether dismissal of Petitioner’s claim was appropriate. Id. The parties have briefed the
matter as indicated above, and this case is now ripe for a determination.
II. Factual Background6
Ms. Block was administered a flu vaccine on November 10, 2017, at approximately
9:48 AM,7 at Mercy Clinic Internal Medicine, her primary care provider. Ex. 4 at 153, 308-
10. At the time of vaccination, Petitioner was 30 years old, with a prior medical history of
Ehlers-Danlos syndrome, epilepsy, migraines, pseudotumor cerebri, pineal gland cysts,
post-partum urinary dysfunction, and torn right hip labrum. Exs. 4 at 189, 358-59; 7 at
1187, 1204, 2261-62; 9 at 39-40.
Three days following her vaccination, on November 13, 2017, Petitioner returned
to Mercy Clinic Internal Medicine with complaints of numbness, tingling, weakness,
muscle aches, and shortness of breath. Ex. 4 at 169. Petitioner reported that “[o]n 11/11
her hands and feet went numb around 10 am.” Id. She described worsening numbness
and tingling thereafter that had progressed above her elbows and knees. Id. On
examination, Petitioner was observed to have abnormal gait, general weakness, and
diminished sensation. Id. at 172. She was directed to go to the Mercy Hospital emergency
room for evaluation of GBS. Id.
Petitioner was admitted to the Mercy Hospital emergency room later that day. Ex.
7 at 1171. On intake, Petitioner was evaluated by Patrick Kane, M.D., who noted that
Petitioner had received a flu vaccination three days earlier, and “[t]he following morning
she woke with paresthesias and numbness to the bilateral hands and feet.” Id. Dr. Kane
recorded that Petitioner’s symptoms had progressed proximally to the elbows and knees,
and she was currently experiencing difficulty walking due to weakness. Id. Dr. Kane
indicated that Petitioner would be admitted for continued management. Id. at 1177.
Petitioner was thereafter evaluated by Binu Mathew, M.D., an internist, on
November 13, 2017. Id. at 1204. Dr. Mathew recorded a history of diarrhea for two-to-
6 A more complete recitation of the facts can be found in the Petition, Respondent’s Rule 4(c) Report,
Petitioner’s expert report, and the parties’ briefing. Although I have reviewed all of the records filed to date,
I have limited my discussion in this decision to the records most relevant to the issue of entitlement, with a
particular focus on the onset of Petitioner’s alleged injury.
7 The medical record in connection with Petitioner’s vaccination appointment indicates it was completed
“11/10/2017 9:48 AM,” and it was electronically signed “11/10/2017 9:49 AM.” Ex. 4 at 308.
3

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three weeks, and further noted that Petitioner had developed cramping, as well as upper
and lower extremity numbness, the day following her vaccination. Ex. 7 at 1204. Dr.
Mathew confirmed that a lumbar puncture had been completed and the results showed
normal CSF protein. Id. Based on his examination, Dr. Mathew expressed concern for
GBS and stated that “a recent diarrheal illness” might have been a trigger. Id. at 1208.
However, Dr. Mathew indicated that Petitioner’s neurological examination was “quite
variable,” which also raised concerns regarding a possible functional disorder. Id.
Petitioner subsequently underwent a neurology consultation with Gwyneth
McCawley, M.D., on November 13, 2017. Id. at 1186. Petitioner stated that she had
experienced sudden onset of numbness in her hands and feet the day following her flu
vaccination that progressively worsened. Id. Petitioner indicated that her daughter had
recently had a sinus infection, and Petitioner had episodes of diarrhea for the previous
two weeks. Id. at 1187. On examination, Petitioner presented with weakness of the upper
and lower extremities, decreased sensation, and diminished Achilles deep tendon
reflexes. Id. at 1191. Dr. McCawley concluded that Petitioner’s symptoms were most
concerning for GBS; however, Dr. McCawley noted atypical features, including generally
preserved reflexes and normal CSF protein. Id. at 1193. Petitioner was initiated on a
course of IVIG. Id.
The next day, Petitioner was evaluated by Aaron Pickrell, M.D. Id. at 1211-13. Dr.
Pickrell observed that Petitioner’s presentation was concerning for GBS and stated that
her recent diarrheal illness might have been a trigger. Id. at 1212. However, Dr. Pickrell
recorded that “her neurological exam was quite variable, somatization?” Id. Petitioner was
continued on IVIG with a plan for a five-day course of treatment. Id.
Petitioner had a follow-up neurology evaluation with Dr. McCawley on November
16, 2017. Dr. McCawley noted that Petitioner’s symptoms were stable, but that she
required assistance with standing and walking. Id. at 1245. Given Petitioner’s atypical
GBS features, Dr. McCawley ordered additional lab testing8 and an EMG/NCV study. Id.
at 1250-51.
The following day, Petitioner underwent an EMG/NCV study of her upper and lower
extremities, which was normal.9 Ex. 7 at 1285. Petitioner had a follow-up with Dr.
McCawley later that day, who noted that normal EMG/NCV results could be seen in the
8 Dr. McCawley ordered lab testing for anti-ganglioside antibodies to assess whether Petitioner had an
autonomic variant of GBS that featured preserved reflexes. Ex. 7 at 1250. Dr. McCawley also ordered an
autoimmune dysautonomia panel. Id. The lab testing for anti-ganglioside antibodies was negative, whereas
the autoimmune dysautonomia panel was negative with the exception of elevated neuronal (V-G) and
GAD65 Ab Assay. Id. at 1355-59, 1369-70.
9 A notation associated with the EMG/NCV study indicated that Petitioner developed weakness of the upper
and lower extremities with paresthesias “approximately 6 days ago” (i.e., November 11). Ex. 7 at 1285.
4

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early course of GBS. Ex. 7 at 1265. Because Petitioner’s presentation remained atypical,
Dr. McCawley ordered an MRI of Petitioner’s brain as well as a repeat MRI of Petitioner’s
cervical/thoracic spine10 to confirm that there was no interval development of white matter
lesion. Id. Dr. McCawley stated that, if the aforementioned imaging were normal, she
would continue to believe the most likely diagnosis was GBS. Id. Petitioner underwent
MRIs of her brain and cervical spine on November 18, 2017, which were normal and/or
unchanged from previous studies. Id. at 1318-19. An MRI of Petitioner’s thoracic spine
revealed possible arachnoid cyst with ventral displacement of the spinal cord at T4-5 level
with potential herniation. Id. at 1319-20.
Petitioner underwent a thoracic CT myelogram and repeat lumbar puncture on
November 21, 2017. Id. at 1288, 1297, 1318. Later that day, Cyrus King, M.D., a
neurosurgeon, noted that it was not “overtly apparent” that Petitioner had a spine
herniation based on the myelogram. Id. at 1298.
On November 22, 2017, Petitioner underwent a neurology evaluation with Anna
Conti, M.D. Id. at 1308-13. Dr. Conti recorded that Petitioner had received a flu vaccine
and presented with weakness/sensory loss in the hands and feet, autonomic instability
with abnormal sweating, and tachycardia starting the next day. Id. at 1308, 1313. Dr. Conti
confirmed that Petitioner completed a five-day course of IVIG and had experienced
improvement of her symptoms. Id. at 1313. On examination, Petitioner was observed to
have horizontal nystagmus, generalized weakness of extremities, decreased sensation,
and 2+ deep tendon reflexes. Id. Dr. Conti indicated that a thoracic disc herniation likely
explained Petitioner’s hyperreflexia, whereas Petitioner’s clinical history and post-IVIG
improvement were more consistent with GBS. Id. Dr. Conti stated that “[c]hronic
demyelinating neuropathy are in differential, but [patient] does not feet [sic] temporal nor
EMG criteria, as of yet.” Id.
Petitioner was discharged from Mercy Hospital later that day. At the time of
discharge, Robert Long, M.D., noted that Petitioner had a previous two-to-three week
history of diarrhea, and she had begun experiencing progressive numbness starting the
day following her flu vaccination. Id. at 1314. Petitioner’s discharge diagnosis was
seronegative GBS, and she was noted to be in improved condition. Id. at 1315, 1320.
Petitioner was discharged to inpatient rehabilitation and physical therapy at Mercy
Rehabilitation Hospital. Id. at 1314, 1323-24.
Following her admission to Mercy Rehabilitation Hospital, Petitioner was evaluated
by Adam Edelman, M.D., an internist, on November 23, 2017. Ex. 9 at 39-46. Dr. Edelman
provided a summary of Petitioner’s hospital course and recorded that she had previously
been undergoing outpatient therapy for right lower extremity weakness. Id. at 39.
10 Petitioner had previously undergone an MRI of her cervical and thoracic spine on November 13, 2017.
Ex. 7 at 1312-13.
5

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Petitioner’s diagnoses included GBS and recent diarrheal illness, the latter of which was
noted as “possibly related to development of GBS.” Ex. 9 at 46.
Petitioner received treatment at Mercy Rehabilitation Hospital from November 22,
2017 through December 5, 2017. At the time of discharge, Petitioner’s lower extremity
weakness had improved, although she continued to experience lower extremity tingling.
Id. at 474, 485-86. Approximately one week later, on December 11, 2017, Petitioner had
an outpatient physical therapy evaluation with Sara Baumgartner.11 Ex. 8 at 2. It was
noted that Petitioner began having lower extremity pain and paresthesia while running
errands the day following her flu vaccination. Id.
At an outpatient follow-up neurology appointment with Dr. McCawley on December
15, 2017, Petitioner reported continuing sensory loss, difficulty moving her legs, and
muscle spasms. Ex. 25 at 13. Dr. McCawley stated that she did not have a clear diagnosis
of Petitioner’s condition, although it was possible Petitioner had a GBS variant versus an
autoimmune neuropathy. Id. at 21.
The next month, on January 26, 2018, Petitioner had another follow-up
appointment with Dr. McCawley.12 Id. at 41. Petitioner indicated that she was undergoing
therapy and her symptoms had improved, but she experienced periods where her body
and extremities went numb throughout the day. Id. at 42. Petitioner additionally reported
new-onset dizziness over the previous six weeks. Id. Dr. McCawley ordered an EEG
study13 and directed Petitioner to continue therapy. Id. at 48.
On May 18, 2018, Petitioner returned to Dr. Hamm, her primary care physician, for
treatment of a rash. Ex. 4 at 275-77. Dr. Hamm recorded that Petitioner’s GBS was now
back to normal, and she was continuing to follow with a neurologist. Id. at 277.
Petitioner had another follow-up appointment with Dr. Hamm on March 21, 2019.
Id. at 407. Petitioner noted that, since her GBS onset, she had experienced numbness
on the bottom of her feet, intermittent paresthesia in the extremities, and weakness. Id.
at 408. Dr. Hamm’s assessment was “GBS – with stable residual symptoms.” Id. at 410.
At an appointment with Dr. Hamm one year later, on March 5, 2020, Petitioner
again reported numbness, paresthesia, and weakness since the onset of GBS. Ex. 23 at
11 Petitioner continued to receive physical therapy for treatment of the residual effects of GBS, in addition
to symptoms relating to hyperextension/Ehlers-Danlos Syndrome and back/hip pain, through November
2018. See Exs. 8 at 8-268; 10 at 1-46.
12 Petitioner had an intervening appointment with Dr. Hamm, her primary care physician, on December 22,
2017. Ex. 4 at 194-96.
13 An EEG study completed on February 8, 2018 was normal. Ex. 25 at 60-61.
6

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79. Dr. Hamm’s assessment remained as “GBS – with stable residual symptoms.” Id. at
81. There are no records of any subsequent treatment.
III. Expert Report
In conjunction with her written response to the show cause order, Ms. Block filed
an expert report, dated September 1, 2020, from David M. Simpson, M.D. Ex. 13
(“Simpson Rep.”). Dr. Simpson is a professor of neurology and the director of the
Neuromuscular Division and Clinical Neurophysiology Laboratories at the Icahn School
of Medicine at Mount Sinai, where he has served as an attending neurologist for the past
thirty-seven years. Simpson Rep. at 1. Dr. Simpson indicated that his specialty area in
neurology is neuromuscular disorders, and he has treated patients with GBS. Id. As
shown in his CV, Dr. Simpson has authored several peer-reviewed publications on
neurological disorders. Ex. 14 at 21-32.
Following a review of Petitioner’s relevant medical records, Dr. Simpson opined
that it was more likely than not that the administration of the flu vaccine on November 10,
2017 caused Petitioner’s GBS. Simpson Rep. at 8. Dr. Simpson explained that there are
several biologic mechanisms by which vaccines may lead to neurologic illness, including
molecular mimicry, neurotoxic effect, immune complex formation, and loss of self-
tolerance. Id. at 5-6. Regarding molecular mimicry in particular, Dr. Simpson asserted that
this causal mechanism was widely accepted in the medical community in the
development of autoimmunity generally and GBS specifically. Id. at 6. Dr. Simpson also
cited to medical literature documenting occurrences of GBS following flu vaccination, and
he opined that there was no persuasive evidence that Petitioner’s GBS was caused by
factors unrelated to the vaccine. Id. at 6-7.
Regarding the specific timing of Petitioner’s GBS onset, Dr. Simpson asserted that
many of Petitioner’s medical providers recorded that Petitioner developed symptoms
within 1-3 days of her receipt of the flu vaccine. Simpson Rep. at 7. However, Dr. Simpson
stated that it was not unusual for patients to lack recall of the precise timing of onset when
reporting symptoms retrospectively. Id. Even so, Dr. Simpson opined that the reported
temporal onset of Petitioner’s neurological symptoms as occurring the day after
vaccination was within a medically-acceptable timeframe. Id.
In support of his opinion, Dr. Simpson cited to Y. Park et al., Clinical Features of
Post-Vaccination Guillain-Barré Syndrome (GBS) in Korea, J. Korean Med. Sci. 2017
Jul;32(7):1154-1159, filed as Exhibit 22 (ECF No. 21-9) (“Park”). Simpson Rep. at 7. Park
reviews post-vaccination GBS cases submitted for compensation to the Korean Advisory
Committee on Vaccination Injury Compensation between 2002 and 2014 as part of the
National Immunization Program in South Korea. Park at 1154-55. Park’s authors note
that of the 48 flu-GBS cases approved for compensation in South Korea during that
7

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period, more than half of the cases (25) involved onset of neurological symptoms within
two days of vaccination. Id. at 1155-56 and Fig. 1. Accordingly, Dr. Simpson opined that
Petitioner’s post-vaccination onset was medically acceptable because it fell within this
timeframe. Simpson Rep. at 7. Park does not, however, discuss whether that timeframe
was deemed medically acceptable, or what set of criteria was applied in awarding injury
compensation in these Korean cases, although it does assert that the GBS diagnoses
were mostly confirmed with commonly-applied diagnostic criteria deemed acceptable by
the world-wide medical/scientific community. Park at 1155.
IV. Parties’ Arguments
In her responsive brief to the show cause order, Ms. Block asserts that she was
entitled to compensation for a GBS injury that was caused-in-fact by the flu vaccination.
Br. at 1, 7. She also provided a summary of the relevant medical records and restated the
assertions made in Dr. Simpson’s report. Id. at 2-7.
In reply, Respondent reiterated that the record evidence preponderantly supported
onset of Petitioner’s GBS within approximately 24 hours after vaccination. Opp. at 8.
Respondent asserted that the above timeframe is not medically acceptable even for a
causation-in-fact claim, and he raised issues regarding the article Dr. Simpson cited to
establish a proximate temporal relationship between vaccination and Petitioner’s GBS.
Id. at 10-12. Respondent otherwise argued that the facts of this case were analogous to
my previous dismissal decision in Rowan, and he noted that Dr. Simpson had not
explained how the biologic mechanisms he cited (e.g., molecular mimicry) could occur
approximately 24 hours after vaccination. Id. For these reasons, Respondent argued that
the petition should be dismissed.
V. Applicable Legal Standards
Under Section 13(a)(1)(A) of the Act, a petitioner must demonstrate, by a
preponderance of the evidence, that all requirements for a petition set forth in section
11(c)(1) have been satisfied. A petitioner may prevail on her claim if the vaccinee for
whom she seeks compensation has “sustained, or endured the significant aggravation of
any illness, disability, injury, or condition” set forth in the Vaccine Injury Table (the Table).
Section 11(c)(1)(C)(i). The most recent version of the Table, which can be found at 42
C.F.R. § 100.3, identifies the vaccines covered under the Program, the corresponding
injuries, and the time period in which the particular injuries must occur after vaccination.
Section 14(a). If petitioner establishes that the vaccinee has suffered a “Table Injury,”
causation is presumed.
8

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If, however, the vaccinee suffered an injury that either is not listed in the Table or
did not occur within the prescribed time frame, petitioner must prove that the administered
vaccine caused injury to receive Program compensation on behalf of the vaccinee.
Section 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-Table or
[an] off-Table” claim and to prevail, petitioner must prove her claim by preponderant
evidence. Section 13(a)(1)(A). This standard is “one of . . . simple preponderance, or
‘more probable than not’ causation.” Althen v. Sec’y of Health & Human Servs., 418 F.3d
1274, 1279-80 (Fed. Cir. 2005) (referencing Hellebrand v. Sec’y of Health & Human
Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993). The Federal Circuit has held that to
establish an off-Table injury, petitioners must “prove . . . that the vaccine was not only a
but-for cause of the injury but also a substantial factor in bringing about the injury.”
Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). Id. at
1352. The received vaccine, however, need not be the predominant cause of the injury.
Id. at 1351.
The Federal Circuit has indicated that petitioners “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The
Circuit Court added that "[t]here must be a ‘logical sequence of cause and effect showing
that the vaccination was the reason for the injury.’” Id. The Federal Circuit subsequently
reiterated these requirements in its Althen decision. See 418 F.3d at 1278. Althen
requires a petitioner
to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination and
injury.
Id. All three prongs of Althen must be satisfied. Id.
Finding a petitioner is entitled to compensation must not be “based on the claims
of a petitioner alone, unsubstantiated by medical records or by medical opinion.” Section
13(a)(1). Further, contemporaneous medical records are presumed to be accurate and
complete in their recording of all relevant information as to petitioner’s medical issues.
Cucuras v. Sec’y of Health & Human Servs., 993, F.2d 1525, 1528 (Fed. Cir. 1993).
Testimony offered after the events in questions is considered less reliable than
contemporaneous reports because the need for accurate explanation of symptoms is
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more immediate. Reusser v. Sec’y of Health & Human Servs., 28 Fed. Cl. 516, 523
(1993).
Analysis
I. Onset of Petitioner’s GBS Likely Occurred Within One Day of Vaccination
In both Petitioner’s responsive brief and Dr. Simpson’s report, the onset of
Petitioner’s GBS was described as occurring within “several days” of her flu vaccination.
Br. at 6-7; Simpson Rep. at 8. Dr. Simpson further proposed that her onset might have
occurred generally within 1-3 days of vaccination, and that it is not unusual for patients to
lack recall of the precise timing of onset when reporting symptoms retrospectively.
Simpson Rep. at 7. Petitioner thus seems to make some effort to prove an onset that
might arguably fall within the Table’s 3-42 day period (even though she indicated in
response to the Order to Show Cause that she does not assert a Table claim).
After reviewing the entire record, I conclude that the onset of Petitioner’s GBS most
likely occurred approximately 24 hours after vaccination. In making this determination, I
find Petitioner’s vaccination record and the progress notes associated with her first post-
vaccination medical appointment to be especially probative. The vaccination record
indicates Petitioner was administered the flu vaccine on November 10, 2017, at
approximately 9:48 AM. Ex. 4 at 153, 308-10. Three days following her vaccination, on
November 13, 2017, Petitioner presented to Mercy Clinic Internal Medicine with
complaints of numbness, tingling, weakness, muscle aches, and shortness of breath. Id.
at 169. She reported that “[o]n 11/11 her hands and feet went numb around 10 am” with
subsequent worsening of her symptoms. Id.
Petitioner’s reported onset of November 11, 2017 at 10:00 AM places her initial
symptoms as occurring approximately 24 hours post-vaccination. In addition to being
detailed and contemporaneous with the events described therein, these records comport
with Petitioner’s affidavits in describing her symptom onset. See generally Exs. 2-3. I
further note that Petitioner’s subsequent medical records similarly describe the onset of
her GBS as occurring the morning of November 11, or (more generally) the day following
her vaccination. See Exs. 7 at 1171, 1186, 1204, 1308, 1313-14; 8 at 2.
I give more weight to the above evidence than to Dr. Simpson’s assertion that
Petitioner’s symptoms began in a more vague post-vaccination timeframe. I also do not
find Dr. Simpson’s statement regarding patient recall – i.e., that patients commonly lack
recall of the precise timing of onset when reporting symptoms retrospectively – to be
especially helpful in this matter. Indeed, Dr. Simpson did not cite any authority (e.g.,
medical literature) to support this statement. And at Petitioner’s initial post-vaccination
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medical encounters during which she described her symptoms, she was relating events
that had occurred only two days earlier. See Cucuras v. Sec’y of Health & Human Servs.,
993 F.2d 1525, 1528 (Fed. Cir. 1993) (noting that contemporaneous medical records are
generally presumed to be accurate and complete in their recording of relevant information
regarding medical issues). It is reasonable to assume Petitioner accurately informed
treaters when her symptoms began – especially since the record is consistent on this
point. Accordingly, the cumulative record evidence preponderantly supports onset of
Petitioner’s GBS within approximately 24 hours after vaccination.
II. Resolution of a Causation-in-Fact Claim Will Require More Evidence
Because Petitioner’s onset most likely began outside the Table’s defined
timeframe for a flu-GBS claim, no Table claim can succeed in this case. Petitioner,
however, argues that the timeframe for onset, whatever it is, could still be sufficient to
support a non-Table, causation-in-fact claim.
Here, if I ignore for the sake of argument some of Respondent’s other objections,
the success of Petitioner’s non-Table claim would turn on the third Althen prong (i.e.,
whether Petitioner has established onset within a medically acceptable timeframe).14 Dr.
Simpson opined that the timeframe was medically acceptable, relying on Park for his
assertion rather than his own experience or research treating GBS. Simpson Rep. at 7.
Park is, however, not a particularly strong piece of evidence. Initially, although Park
purports to document cases of GBS occurring within two days of receipt of the flu vaccine,
it is unclear whether all of the short-onset cases in fact constituted GBS – indeed, the
authors note that 18 of the 48 flu-GBS cases studied had a comparatively low level of
diagnostic certainty. Park at 1158. The authors also acknowledge that pre-vaccination
infection could not be excluded as a causative factor in approximately 10 percent of the
total compensated flu-GBS cases. Id.
Park is also opaque as to the specific standards governing the award of
compensation under the South Korean program. And it does not discuss whether a GBS
onset less than two days post-vaccination is medically acceptable, or explain how a flu
vaccine can cause GBS within that timeframe. Park therefore only establishes instances
of a temporal association between vaccination and GBS – something recognized as not
sufficient to meet a claimant’s preponderant burden. See Grant v. Sec'y of Health &
14 The first Althen prong is not reasonably in dispute, since there is preponderant evidence supporting a
causal association between the flu vaccine and GBS, as recognized by numerous prior Program decisions.
Respondent has, however, questioned the validity of Petitioner’s GBS diagnosis, asserting that her records
lacked evidence of neurological and other clinical findings consistent with this condition. Res. Report at 10-
11. And Respondent noted possible alternative causes for GBS, such as the medical record evidence that
Petitioner may have had a pre-vaccination illness (reflected as a course of diarrhea) that actually caused
her condition (although Dr. Simpson raises objections in his report to this contention).
11

Case 1:19-vv-00969-UNJ Document 26 Filed 05/28/21 Page 12 of 13
Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (“a proximate temporal association
alone does not suffice to show a causal link between the vaccination and injury”).
In addition, there are other sound reasons to question a one-day GBS onset.
Previous flu-GBS non-Table claims adjudicated in the Program have mostly not
succeeded where onset occurred earlier than three days after vaccination. See generally
Rowan, 2020 WL 2954954, at *16-19 (36-hour post-vaccination onset of GBS for elderly
individual was not a medically-acceptable timeframe to support non-Table claim); Orton
v. Sec’y of Health & Human Servs., No. 13-631V, 2015 WL 1275459, at *3-4 (Fed. Cl.
Spec. Mstr. Feb. 23, 2015) (one-day onset of GBS after flu vaccine administration not
substantiated with expert opinion). While these determinations do not control this
outcome, they demonstrate that what is known medically/scientifically about the
pathogenesis of GBS weighs against findings of flu vaccine causality when the onset is
too close temporally to the vaccination event. Petitioner for her part has cited no contrary
cases finding a one-day onset to be medically acceptable.15
Despite all of the above, it certainly is not the case in the Program that a claimant
could never establish a non-Table flu-GBS claim based on a very short onset. And here,
I find that Petitioner has offered barely enough evidence on the third Althen prong (in the
form of the combined opinion of Dr. Simpson plus Park) to allow the claim to go forward
for now. Despite my reservations about Park, it does provide some reliable evidence that
a small group of individuals who likely had GBS experienced a short onset post-
vaccination. Respondent, by contrast, has yet to provide rebuttal evidence that would
undermine that conclusion. The citation to cases like Rowan, while highly relevant, do not
do the job – for Rowan involved an elderly individual whose immune response was likely
to take far longer than what she actually experienced. Petitioner herein, by contrast, was
much younger.
My determination not to dismiss the claim at this time arises not from my view that
Petitioner has a chance of success, but rather reflects my conclusion that the evidence
adduced to date would, if unrebutted, barely support entitlement. Respondent will be
given the opportunity now to file an expert report or other evidence rebutting the
contention that a one-day onset is medically acceptable – and if he does so, the balance
will likely tip against Petitioner.
15 Those cases that have gone the other way are factually distinguishable in part. See generally Lehrman
v. Sec’y of Health & Human Servs., No. 13-901V, 2018 WL 1788477, at *14-19 (Fed. Cl. Spec. Mstr. Mar.
19, 2018). The Lehrman petitioner, however, was found to have a pre-vaccination history of upper
respiratory infection which, in combination with the flu vaccination, was found to have resulted in an
upregulation of the petitioner's immune system that led to a rapid onset of GBS. Id. Here, Petitioner has not
presented comparable evidence to establish that her GBS onset within 24 hours of vaccination was
medically acceptable under the specific facts of this case.
12

Case 1:19-vv-00969-UNJ Document 26 Filed 05/28/21 Page 13 of 13
Conclusion
Petitioner cannot proceed on a Table claim in this matter, and therefore any such
claim is dismissed. Petitioner’s non-Table claim, however, may proceed. Respondent
shall file an expert report and/or any other evidence bearing on the third Althen prong16
on or before June 30, 2021. Petitioner shall thereafter be afforded the opportunity to file
a rebuttal report from Dr. Simpson, and then I shall decide the claim based on these
additional filings.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
16 The case’s disposition is still likely to turn on the timeframe issue, and therefore the parties are advised
to limit additional briefing or filings to it. If I ultimately determine dismissal is still inappropriate, I will set the
matter for hearing, at which point other issues raised about the claim (such as alternative cause) can be
addressed.
13

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_19-vv-00969-1
Date issued/filed: 2021-12-02
Pages: 9
Docket text: PUBLIC DECISION (Originally filed: 10/29/2021) regarding 32 DECISION of Special Master Signed by Chief Special Master Brian H. Corcoran. (jas) Service on parties made.
--------------------------------------------------------------------------------
Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 1 of 9
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-969V
UNPUBLISHED
COLLEEN BLOCK, Chief Special Master Corcoran
Petitioner, Filed: October 29, 2021
v.
Special Processing Unit (SPU); Off-
SECRETARY OF HEALTH AND Table Dismissal; Influenza (Flu);
HUMAN SERVICES, Guillain-Barré syndrome (GBS);
Althen Prong Three; One-Day Onset;
Respondent. Adaptive Immune Response.
Lia Obata Dowd, Dowd & Dowd, P.C., St. Louis, MO, for Petitioner.
Jeremy Fugate, U.S. Department of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION1
On July 3, 2019, Colleen Block filed a petition for compensation under the National
Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine
Act”). Petitioner alleged that she suffered Guillain-Barré syndrome (“GBS”) as a result of
an influenza (“flu”) vaccine administered on November 10, 2017. Petition at 1-2. The case
was assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”).
On April 26, 2021, after consideration of the medical record and other filed
evidence, I concluded that Petitioner had experienced the onset of her alleged GBS
1 Because this unpublished opinion contains a reasoned explanation for the action in this case, I am
required to post it on the United States Court of Federal Claims' website in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the opinion will be available to anyone with access to the internet.
In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or
other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon
review, I agree that the identified material fits within this definition, I will redact such material from public
access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).

Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 2 of 9
symptoms within approximately 24 hours of vaccination – outside of the 3 to 42-day period
prescribed for a Table flu/GBS injury – thus, constituting grounds for dismissal of that
claim. See generally Findings of Fact and Conclusions of Law (ECF No. 25) (“Table Claim
Dismissal”). In so doing, I also observed that Petitioner’s submission of an expert report
from a neurologist, Dr. David Simpson, barely supported even a causation-in-fact version
of the claim. But I noted that I would permit both sides to submit additional evidence on
the medical acceptability of onset for a non-Table version of the claim. Table Claim
Dismissal at 11-13.3
Both parties have offered legal responses4 and expert materials5 on this issue.
Having reviewed these materials in light of my prior opinion, I hereby conclude that
Petitioner has not established by a preponderance of the evidence that the onset of GBS
within 24 hours of receipt of the flu vaccine is medically acceptable. Therefore, she cannot
establish causation-in-fact and her non-Table claim is hereby dismissed.6
I. Evidentiary and Expert Submissions
A. Respondent’s Experts
On June 10, 2021, Respondent filed reports from two experts. The first, Norman
Werdiger, M.D., has been employed at the Yale University School of Medicine since 1982
and specifically as a clinical associate professor of neurology since 2006. See Werdiger
3 My prior summary of the relevant procedural history, underlying facts, Petitioner’s expert’s first report,
parties’ arguments, applicable legal standards, and my initial analysis concerning the feasibility of
Petitioner’s off-Table flu/GBS claim are set forth at length in the Table Claim Dismissal, and fully
incorporated and relied upon herein.
4 Petitioner’s Brief filed September 1, 2020 (ECF No. 20); Respondent’s Brief filed October 30, 2020 (ECF
No. 24). While the briefs were filed prior to the Table Claim Dismissal (and are cited therein), those briefs
address whether Petitioner has established an off-Table claim.
5 See Expert Report of David Simpson, M.D. dated September 1, 2020, filed as Ex. 13 (ECF No. 21)
(“Simpson Rep.”); Expert Report of Norman Werdiger, M.D., dated June 4, 2021, filed as Ex. A (ECF No.
27-1) (“Werdiger Rep.”); Expert Report of Neil Romberg, M.D., dated June 10, 2021, filed as Ex. N (ECF
No. 28-1) (“Romberg Rep.”); Supplemental Report of David Simpson, M.D., dated August 29, 2021, filed
as Ex. 26 (ECF No. 30) (“Simpson Supp. Rep.”).
6 While this opinion discusses the elements of the record that were emphasized by the parties and that I
found most relevant to the outcome, I have reviewed and considered the entire record, including all of the
literature submitted by both parties. Section 13(a)(1); see also Moriarty v. Sec’y of Health & Human
Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“we generally presume that a special master considered
the relevant record evidence even though he does not explicitly reference such evidence in his decision”);
Simanski v. Sec’y of Health & Human Servs., 115 Fed. Cl. 407, 436 (2014) (“a special master is not
required to discuss every piece of evidence in [his] decision”) (internal citation omitted), aff’d, 601 Fed.
Appx. 982 (Fed. Cir. 2015).
2

Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 3 of 9
Rep. at 2. Dr. Werdiger retired his private neurology practice in August 2019 but continues
to provide outpatient general neurological care through his affiliation at Yale. Id. In the
past five years, he has seen or participated in the treatment of approximately ten patients
with GBS. Id. He has not authored any publications that inform this case but based his
opinion on a review of the relevant literature.
Respondent’s second expert, Neil Romberg, M.D., joined Yale University as a
fellow in allergy and clinical immunology from 2008 to 2011, then served as an associate
professor and the director of Yale’s Pediatric Immune Deficiency Clinic from 2011 to 2015.
See Romberg Rep. at 1. Since 2015, he has served as an assistant professor of pediatrics
at the University of Pennsylvania School of Medicine and an attending physician at the
Children’s Hospital of Philadelphia. Id. at 1-2. Dr. Romberg has focused his career on
researching the molecular mechanisms, as well as providing appropriate treatment, for
immunological disorders. Id. He asserted that he is aware of the classic findings as well
as the immunological basis of GBS. Id. at 1, 5.
Respondent’s experts both take issue with an item of literature that was offered in
connection with the submission of Petitioner’s earlier expert report (and discussed at
length in the Table Claim Dismissal), Park. See Table Claim Dismissal at 7-8, 11-12. Drs.
Werdiger and Romberg both note that although Park describes the South Korean
government’s compensation of claims for post-vaccination GBS, including instances in
which the illness purportedly manifested within two days, approximately one-third of the
total cases were not confirmed diagnostically. Additionally, approximately one-tenth of the
cases at issue may have been caused by unrelated infections. Werdiger Rep. at 14;
Romberg Rep. at 8. Otherwise, these experts argue, the South Korean government’s
decision to compensate certain cases of purported GBS manifesting less than two days
of vaccination does not establish anything with regard to causation. Werdiger Rep. at 14;
Romberg Rep. at 8.
Respondent’s experts further discussed the pathophysiology of GBS and how that
relates to its clinical onset after a triggering event. As they explained, GBS occurs when
a genetically susceptible individual encounters an environmental agent which causes an
adaptive immune response, including T cells and antibodies, misdirected against specific
targets in the peripheral nervous system. The misdirection occurs due to molecular
mimicry between amino acid sequences on the proteins of the pathologic/presenting
antigens and the similar sequences in the protein components of nerve structures.
Romberg Rep. at 6; Werdiger Rep. at 12 (citing K. Sheikh, Review: Guillain-Barré
Syndrome, 26 Continuum – Peripheral Nerve and Motor Neuron Disorders 1184 (2020),
filed as Exhibit D (ECF No. 27-4) (“Sheikh”)).
3

Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 4 of 9
Dr. Romberg opined that the time it would take for this process to result in the
onset of GBS could not occur within one day of exposure to the precipitating
environmental agent. Rather, the adaptive immune response is “more deliberate,” and
will involve “a delay between exposure and onset of symptoms,” in contrast to the more
rapid, but nonspecific, innate immune response. Romberg Rep. at 8, citing C.A. Janeway
et al., Principles of Innate and Adaptive Immunity, in Immunobiology: The Immune
System in Health and Disease (5th ed. 2001), filed as Exhibit X (ECF No. 28-11).
Dr. Romberg acknowledged that certain epidemiologic evidence seemed facially
to allow for the possibility of a short onset, but he opined that this evidence was ultimately
thin and quite limited. One such article, long cited in favor of the flu vaccine-GBS
association, reported that a small number of GBS cases observed – 10 out of 532, or
1.8% - manif within two days of vaccination. Romberg Rep. at 7-8, citing L. Schonberger
et al., Guillain-Barré Syndrome Following Vaccination in the National Influenza
Immunization Program, United States, 1976 – 1977, 100 Am. J. Epidem. 105 (1979), filed
as Ex. 19 (ECF No. 21-6) (“Schonberger”). A later meta-analysis of 23 million adverse
events reported after flu vaccines, found only 54 instances of GBS - with 51 of them (95%)
showing onset within two days. Romberg Rep. at 9, citing D.A. Salmon et al., Association
Between Guillain- Barré Syndrome and Influenza A (H1N1) 2009 Monovalent Inactivated
Vaccines in the USA: A Meta-Analysis, 381 Lancet 1461 (2013), filed as Ex. Y (ECF No.
28-12 (“Salmon”). Importantly, neither Schonberger nor Salmon address whether the
timing for this small minority of cases is even medically acceptable. Thus, Dr. Romberg
maintained that these findings were inconsistent with what was well understood about
GBS’s pathologic timeframe, as well as too minimal to be meaningful.
Dr. Werdiger agreed with the above, adding that the timeframe issue could be
better grasped by analogizing GBS to another neurological injury also understood to be
mediated by an adaptive immune response - acute disseminated encephalomyelitis
(“ADEM”). Werdiger Rep. at 12, citing A. Rowhani-Rahbar et al., Review: Biologically
Plausible and Evidence-Based Risk Intervals in Immunization Safety Research, 31
Vaccine 271 (2012), filed as Exhibit K (ECF No. 27-11) (“Rowhani-Rahbar”). In discussing
ADEM, Rowhani-Rahbar writes that “Some neurologic events are immune-mediated in
which an immune response involving self-directed antibodies are autoreactive T-cells
generated against neuronal epitopes may occur. Consideration of biologic plausibility of
an AEFI [adverse event following immunization] would require a certain period between
immunization and onset of symptoms.” Id. at 274 (emphasis added). While there is limited
data existing about the shortest possible timeframe between introduction of an antigen,
mounting of a subsequent immune response, and the onset of clinical disease, “an
interval of less than 48 h[ours] would seem to be biologically implausible.” Id. (emphasis
added). As a result, the Centers for Disease Control and Prevention (“CDC”), upon
4

Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 5 of 9
reviewing an individual case of vaccination and ADEM, only considers a potential causal
association when onset is beyond 48 hours. Id. Indeed, more robust epidemiological
studies only consider causation potentially present when the onset exceeds five days. Id.
Dr. Werdiger opined that the same limitations on the timeframe between vaccination and
GBS should apply, because of the diseases’ similar pathophysiology.
B. Dr. Simpson’s Supplemental Report
In his supplemental report,7 Dr. Simpson discussed some of the limitations on Park
raised by Respondent. He acknowledged that over one-third of the GBS diagnoses
discussed by Park were uncertain. Simpson Supp. Rep. at 6. But he maintained that these
cases were nevertheless “reviewed thoroughly and concluded as having GBS by experts
meeting.” Id. In so arguing, however, he did not address the other concern that I raised,
and Respondent’s experts echoed – that pre-vaccination infection could not be excluded
as a causative factor in approximately one-tenth of the total compensated flu-GBS cases
considered in Park. Dr. Simpson also suggested that South Korea’s vaccine
compensation program “appears to have notable similarities to that employed by the US
National Vaccine Compensation Program.” Id. However, the only discernable similarity is
that South Korea’s program involves some degree of participation by medical experts.
Dr. Simpson went on to address issues relevant to the timeframe for an aberrant
immune response leading to GBS. He acknowledged that the “early onset of neurological
symptoms” following vaccination is “atypical,” but has nevertheless been reported by
other authors such as Schonberger and Salmon. Simpson Supp. Rep. at 5. He further
opined that there is precedent for his proposed one-day timeframe, as reflected by the
CDC’s defined risk interval of 0 – 48 hours between receipt of inactivated flu vaccine and
febrile seizures. Simpson Supp. Rep. at 6 (citing Rowhani-Rahbar at 273). However, Dr.
Simpson did not explain why febrile seizures, rather than ADEM, are a more useful
analogue for GBS. And he did not dispute that GBS involves an adaptive immune
response, in which it would take time both for the adaptive response to mount and then
for the autoimmune attack to cause symptoms.
7 Dr. Simpson devoted several pages to addressing other points raised by Respondent’s experts, including
whether GBS is the correct diagnosis for Petitioner’s injury and whether her injury was more likely caused
by a preceding diarrheal illness. Simpson Supp. Rep. at 2-5. I have reviewed both parties’ positions on
those issues, but find them unnecessary to resolve, in light of the dispositive onset issue which is discussed
above.
5

Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 6 of 9
II. Legal Standard for Althen Prong Three
As previously noted, a temporal association alone between vaccination and
disease onset “does not suffice to show a causal link” between the two. Table Claim
Dismissal at 11 (quoting Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144, 1148
(Fed. Cir. 1992)). Rather, under the third prong set by the Federal Circuit in Althen v.
Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005), a petitioner is required
to establish a “proximate temporal relationship” between the vaccination and the injury
alleged. Althen, 418 F.3d at 1281 (emphasis added). That relationship must ultimately be
“medically acceptable.” Id.
To establish this prong, 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 & Human 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 & Human 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 & Human 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 1329 (Fed. Cir. 2014).
III. Analysis
Over a year ago, I warned Petitioner that (even despite the fact that within the
Vaccine Program, GBS is widely understood to be associated with flu vaccine), a GBS
onset within 24 hours of receipt of flu vaccine would likely thwart even an off-Table claim.
Order to Show Cause (ECF No. 18) (citing Rowan v. Sec’y of Health & Human Servs.,
No. 17-760V, 2020 WL 2954954 (Fed. Cl. Spec. Mstr. April 28, 2020) (finding that GBS
is known to be mediated by autoantibodies produced via the adaptive immune system,
and this process, if vaccine-induced, likely takes longer than three days to result in
symptoms). Then, in dismissing Petitioner’s Table claim, I noted that her expert’s first
report and supporting literature (chiefly the Park article) “would, if unrebutted, barely
support entitlement,” but that the short timing was still an area of significant risk that would
likely prove to be dispositive. Table Claim Dismissal at 12-13. Respondent has now filed
rebuttal evidence on this point, which Petitioner has not overcome.
Petitioner’s argument continues to rely solely on one item of evidence - the Park
article – to support a one-day onset for GBS after the flu vaccine. But as Respondent’s
experts have established, Park is not entitled to great weight for the reliability of its
6

Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 7 of 9
medical findings. Over one-third of the cases (18/48, or 37.5%) considered by Park met
only the “lowest level” of diagnostic certainty for GBS, because of incompatible or
insufficient testing. Park at 1158. Thus, it cannot be presumed that all cases at issue,
whatever the onset, were in fact GBS. Park does not explain why the South Korean
government decided to accept the claimed diagnosis in those cases, and Park in fact
emphasizes that “complete treatment and testing results need to be obtained” to properly
evaluate the incidence of GBS following vaccination. Id. at 1158-59. Dr. Simpson has only
added that South Korea’s program appears to include some degree of medical review,
but he has not addressed the standard for compensation8 or who makes the final
determination.9
Most importantly, Petitioner has not preponderantly established that from an
immunologic standpoint, GBS could acceptably begin in so short a timeframe. On this
subject, Dr. Simpson was not persuasive. Notwithstanding his general medical education
and expertise treating neurological disorders including GBS,10 Dr. Simpson lacks the
requisite immunological background to credibly support the short timeframe. It is
reasonable for me to give less weight to his opinion, given his reduced expertise regarding
this critical question. See Rowan, 2020 WL 2954954 at *18 ( “despite his overall
testimonial qualifications, [the petitioner’s expert] cannot point to any personal research
or direct expertise on the question of the timeframe for vaccine-induced GBS onset”).
Dr. Simpson demonstrated his lack of immunological expertise upon attempting to
analogize the onset of post-vaccine GBS to that of post-vaccine febrile seizures. Simpson
Supp. Rep. at 6 (citing Rowhani-Rahbar at 273). The two simply are not comparable, for
(as discussed in many prior decisions) the theory of vaccine-induced seizure involves an
aberrant innate immune response, generating fever and (subsequently) seizure. See
Caredio v. Sec’y of Health & Human Servs., No., 2021 WL 4100294, at *30 (Fed. Cl.
Spec. Mstr. July 30, 2021) (citing Ginn v. Sec’y of Health & Human Servs., No. 16-1466V,
2021 WL 1558342 (Fed. Cl. Spec. Mstr. Mar. 26, 2021)); Tembenis v. Sec’y of Health &
8 Y. Choe and G. Bae, Review: Management of Vaccine Safety in Korea, 2 Clin. Exp. Vaccine Res. 40, 44
(2013), available at https://pubmed.ncbi.nlm.nih.gov/23596589/ (providing that South Korea provides for
compensation in cases where vaccine causation is “definite, probable, or possible,” as defined by the World
Health Organization) (emphasis added).
9 R. Mungwira et al., Research Article: Global Landscape Analysis of No-Fault Compensation Programmes
for Vaccine Injuries: A Review and Survey of Implementing Countries, 15 PLOS ONE e0233334, 7 (2020),
available at https://doi.org./10/1371/journalpone.02333334 (discussing that some countries have “purely
administrative programs” overseen by medical experts, compared to other countries, such as the United
States, in which “the final decision on compensation is made by legal experts.”).
10 See also Q.P. v. Sec’y of Health & Human Servs., No. 15-449V, 2019 WL 4013436 (Fed. Cl. Spec. Mstr.
July 29, 2019) (finding that Dr. Simpson’s limited experience in the Vaccine Program, his work as an expert
neurologist merited $500.00 per hour).
7

Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 8 of 9
Human Servs., No. 03-820V, 2010 WL 5164324, at *15-16 (Fed. Cl. Spec. Mstr. Nov. 29,
2010). This can in fact occur rapidly (since the innate response begins occurring close-
in-time to a vaccine’s administration) - and thus is inapposite to GBS, which (despite its
acute and monophasic course once it becomes clinically evident) “involves the more
deliberate adaptive immune system rather than just the rapid actions of innate immune
cells.” Romberg Rep. at 8.
Respondent’s experts, by contrast, more persuasively opined that the
understanding of immunologic processes that mediate and drive GBS likely do not occur
so quickly after a triggering event. Upon introduction of the foreign pathogen (or vaccine
antigen), it takes several days for the activation of the adaptive immune response and the
production of antibodies, followed by any autoimmune attack on the peripheral nervous
system and resulting clinical manifestations. Romberg Rep. at 6; Werdiger Rep. at 12;
see also Rowan, 2020 WL 2954954, at *17 (citing Forrest v. Sec’y of Health & Human
Servs., No. 14-1016V, 2019 WL 925495, at *6 (Fed. Cl. Spec. Mstr. Jan. 28, 2019)
(explaining that these lag and “log” phases are sequential)).
As a final point, I am resolving Petitioner's claim on the papers rather than via
hearing. 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 & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020);
see also v. Hooker Sec’y of Health & Human 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. 3 97, 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 & Human Servs., No. 90-882V,
1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).
Here, Ms. Block has long been made aware that the issue of the timing in her case
was likely to be dispositive, directed to my prior rulings on this point, and given several
opportunities to provide evidence to support a different result (such as unique
circumstances, a more qualified expert, or medical literature supporting an evolving
understanding of the immune response that manifests in GBS). She has not done so.
8

Case 1:19-vv-00969-UNJ Document 35 Filed 12/02/21 Page 9 of 9
Conclusion
Petitioner has not established that the onset of GBS within one day of a flu vaccine
is medically acceptable under Althen prong three. Therefore, she cannot establish
causation-in-fact, and her off-Table claim must be dismissed. In the absence of a timely-
filed motion for review (see Appendix B to the Rules of the Court), the Clerk shall enter
judgment in accordance with this decision.11
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
11 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice
renouncing their right to seek review.
9