Court Opinion

ID: 4691296
Source: CourtListenerOpinion
Date Created: 2021-05-28 20:04:20.256978+00
Date Added: 2024-06-11T08:05:07.401617
License: Public Domain

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                                        UNPUBLISHED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1 Because this unpublished Ruling contains a reasoned explanation for the action in this case, I am required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).
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.

3Ms. Block later filed an Amended Petition on October 27, 2019 correcting citations used in the original
Petition. ECF No. 9.

4Respondent 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.

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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
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.
9A 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.

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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.

10Petitioner had previously undergone an MRI of her cervical and thoracic spine on November 13, 2017.
Ex. 7 at 1312-13.

                                                 5
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.

12Petitioner 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.

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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
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
        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).

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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.

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                                                    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.

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