Court Opinion

ID: 4663881
Source: CourtListenerOpinion
Date Created: 2021-03-01 21:02:51.072774+00
Date Added: 2024-06-11T08:02:32.144956
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                           No. 20-321V
                                          UNPUBLISHED

    REBECCA RAY,                                                Chief Special Master Corcoran

                         Petitioner,                            Filed: January 13, 2021
    v.
                                                                Special Processing Unit (SPU);
    SECRETARY OF HEALTH AND                                     Findings of Fact; Onset; Influenza
    HUMAN SERVICES,                                             (Flu) Vaccine; Guillain-Barré
                                                                Syndrome (GBS)
                         Respondent.

David John Carney, Green & Schafle, LLC, Philadelphia, PA, for Petitioner.

Ryan Daniel Pyles, U.S. Department of Justice, Washington, DC, for Respondent.

     FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CASE 1

       On March 23, 2020, Rebecca Ray 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 alleges a Table claim for Guillain-Barré syndrome (“GBS”), and
in the alternative asserts a cause-in-fact case for GBS as her injury, as a result of her
receipt of the influenza (“flu”) vaccination on October 9, 2018. Amended Petition, filed
October 16, 2020 at 1, ECF No. 17. The case was assigned to the Special Processing
Unit of the Office of Special Masters (the “SPU”).

1
   Because this unpublished fact ruling contains a reasoned explanation for the action in this case, I am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 fact 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 section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
      For the reasons discussed below, I find that Petitioner’s GBS Table claim must be
dismissed for failure to establish onset within the 3 – 42 day time period following the
administration of vaccination.

    I.      Relevant Procedural History

        After the case’s initiation, Respondent filed his counsel’s informal assessment of
this case in July 2020, pursuant to my Order, and identified several issues that he
maintained precluded the informal resolution of this case in SPU. Most significantly,
Respondent argued that Petitioner had failed to establish that she suffered the Table
injury of GBS, because (a) she reported to her treating providers (as reflected in filed
medical records) that onset of her symptoms occurred on December 22, 2018, and (b)
this reported onset of symptoms (at least 74 days post-vaccination) is significantly longer
than the 3 – 42 day period prescribed by the Table.” 3 Respondent’s Status Report (ECF
No. 13) at 2. This onset is also inconsistent with the onset of approximately one month
alleged by Petitioner in her affidavit. Ex. 2.
        On September 17, 2020, I issued an Order to Show Cause requiring Petitioner to
file an Amended Petition if she was in fact asserting a Table case, and to further Show
Cause why her Table claim should not be dismissed for the reasons discussed above.
ECF No. 16. I further noted in my Order that I intended to reassign this case from SPU as
I expected (based on my own initial review) that Petitioner would not be able to establish
a Table claim, but I would afford her an opportunity to show why dismissal of such a claim
was not appropriate. Id.
        On October 16, 2020, Petitioner filed an Amended Petition alleging a Table claim
for GBS, and in the alternative asserting a cause-in-fact case. ECF No. 17 at 1. Petitioner
also filed a Status Report, in response to my Order to Show Cause, on October 16, 2020,
indicating that she had no objection to this case being transferred out of SPU. ECF No.
18. But Petitioner failed to Show Cause, or otherwise explain or argue, why her Table
claim should not be dismissed stating the evidence she intends to rely upon has been
filed with the court. Id.

3
  This issue was also raised, based on my separate review of the records, at the initial status conference in
this case on May 6, 2020. However, I deferred to schedule further proceedings to address this issue until
Respondent’s counsel had an opportunity to complete his review. ECF No. 12 at 1.

I note that Respondent’s Status Report also raised two additional issues in regard to this case: 1) that it is
unclear whether Petitioner received the flu vaccine on October 8 or October 9, 2018, and 2) that the
persistent IVIG treatment she has received is not consistent with GBS, but instead suggests she may have
experienced a different injury. ECF No. 13. Respondent also raised these points in his Rule 4(c) Report.
ECF No. 21. I do not find that it is necessary to resolve these issues at this time.

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       On January 7, 2021, Respondent filed his Rule 4(c) report. The Report asserts that
the record “clearly establishes” that petitioner’s condition began more than ten weeks
after vaccination (on December 22, 2018), thus well outside of the Table timeframe. ECF
No. 21 at 5. Respondent further argues Petitioner has failed to prove actual causation as
required under Althen, as she has failed to submit an expert report or other preponderant
evidence in support of causation sufficient to satisfy her burden of proof. Id. at 6 (citing
Althen v. Sec'y of Health & Human Servs, 418 F.3d 1274, 1278 (Fed. Cir. 2005)).
    II.      Issue

      At issue is whether Petitioner’s first symptom or manifestation of onset of GBS
occurred within 3 – 42 days of vaccination, as set forth in the Vaccine Injury Table. 42
C.F.R. § 100.3(a)(XIV)(D).

    III.     Authority

       Before compensation can be awarded under the Vaccine Act, a petitioner must
demonstrate, by a preponderance of evidence, all matters required under Section
11(c)(1), including the factual circumstances surrounding her claim. Section 13(a)(1)(A).
In making this determination, the special master or court should consider the record as a
whole. Section 13(a)(1). Petitioner’s allegations must be supported by medical records or
by medical opinion. Id.
        To resolve factual issues, the special master must weigh the evidence presented,
which may include contemporaneous medical records and testimony. See Burns v. Sec'y
of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special
master must decide what weight to give evidence including oral testimony and
contemporaneous medical records). Contemporaneous medical records are presumed to
be accurate. See Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed.
Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a
petitioner may present testimony which is “consistent, clear, cogent, and compelling.”
Sanchez v. Sec'y of Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Human Servs., No.
90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)).
       In addition to requirements concerning the vaccination received, the duration and
severity of petitioner’s injury, and the lack of other award or settlement, 4 a petitioner must

4
 In summary, a petitioner must establish that she received a vaccine covered by the Program, administered
either in the United States and its territories or in another geographical area but qualifying for a limited
exception; suffered the residual effects of her injury for more than six months, died from her injury, or
underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected
an award or settlement for her injury. See § 11(c)(1)(A)(B)(D)(E).

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establish that she suffered an injury meeting the Table criteria, in which case causation
is presumed, or an injury shown to be caused-in-fact by the vaccination she received.
Section 11(c)(1)(C).
        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).
Pursuant to the Vaccine Injury Table, GBS is compensable if it manifests within 3- 42
days (not less than three days and not more than 42 days) of the administration of an
influneza vaccination. 42 C.F.R. § 100.3(a)(XIV)(D). (Further criteria for establishing a
GBS Table Injury case be found under the accompanying qualifications and aids to
interpretation. 42 C.F.R. § 100.3(c)(15)).
       Cases alleging a Table GBS injury have often been dismissed for failure to
establish proper onset. See, e.g., Randolph v. Sec'y of Health & Human Servs., No. 18-
1231V, 2020 WL 542735, at *8 (Fed. Cl. Spec. Mstr. Jan. 2, 2020)(finding GBS onset at
the earliest occurred 76 days post-vaccination, “well outside the 3-42-day window set by
the Table for a flu-GBS claim”); Upton v. Sec'y of Health & Human Servs., No. 18-1783V,
2020 WL 6146058, at *2-3 (Fed. Cl. Spec. Mstr. Sept. 24, 2020) (finding the petitioner did
not establish the onset of his GBS within the 3-42 day time frame prescribed and thus did
not establish a Table Injury).
   IV.    Finding of Fact

       I make these findings after a complete review of the record, including all medical
records, affidavits, and all other additional evidence and filings from the parties.
Specifically, I note the following:

          •   On December 23, 2018, Petitioner was seen at the Emergency Department
              (“ED”) with a chief complaint of bilateral numbness in her hands and feet.
              Ex. 3 at 143. Petitioner’s medical history for this visit indicates that she was
              “seen in the ED because of bilateral upper and lower extremities tingling
              and numbness since yesterday.” Id. (emphasis added). A further history
              recorded that same date notes “44-year-old female presents to the
              Emergency Department with complaint of numbness/tingling in bilateral feet
              to ankle and both hands that started yesterday.” Id. at 145 (emphasis
              added).

          •   On December 24, 2018, Petitioner followed-up with an urgent care visit. Ex.
              3 at 140. The history from that visit provides “44-year-old female patient
              presents to urgent care with complaints of paresthesia of hands and legs.
              Patient states that symptoms started yesterday. She was seen in the
              Emergency Department . . .” Id. Petitioner was referred to the ED for a
              neurologic evaluation. Id. at 141.

                                              4
          •   An ED note from December 24, 2018 indicates that Petitioner presented
              “with numbness and tingling in her hands and feet. She states that this
              started Saturday when she woke up. Yesterday she went to the Emergency
              Department at Mercy Hospital and they did lab tests.” Id. at 138.

          •   Petitioner was seen for a consult on December 24, 2018 with a chief
              complaint of parenthesis, the history of Petitioner’s illness provides that on
              “12/22/2018, the patient developed parenthesis in her feet. They [sic]
              spread gradually to her hands. The next day, she noted some weakness in
              her legs and worse this morning, she felt like her legs were rubber. She had
              no symptoms referable to her vision, but she had some numbness in the
              center of her tongue.” Ex. 3 at 142.

        In contrast to the contemporary records, Petitioner in her March 9, 2020 affidavit,
avers that approximately a month after her vaccination, between early and mid-November
2018, “I started to experience numbness and tingling in my hands and wrists. During this
time, I was frequently experiencing weakness in my legs that lead to my knees buckling,
causing me to lose balance, which had never happened to me before.” Ex. 2 at ¶ 11.
Petitioner indicates that she believed these symptoms were related to a pinched nerve,
as she was actively playing volleyball at the time, so she did not report the symptoms to
a medical professional. Id. Petitioner further asserts in her affidavit that by December 22,
2018, her symptoms began to “significantly worsen” and she had the onset of a new
symptom, numbness of her tongue, which alarmed her and prompted her to seek medical
attention. Id. at ¶14.

       As is self-evident, the contemporaneous records are not consistent with
Petitioner’s later account of the onset of her GBS symptoms in early to mid-November
2018. The aforementioned medical entries evidence that the onset of Petitioner’s GBS
symptoms more likely than not began on December 22, 2018. “Medical records, in
general, warrant consideration as trustworthy evidence. The records contain information
supplied to or by health professionals to facilitate diagnosis and treatment of medical
conditions. With proper treatment hanging in the balance, accuracy has an extra
premium. These records are also generally contemporaneous to the medical events.”
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

      Petitioner has provided no reason for me not to conclude that the medical records
are correct, and she otherwise has failed to show cause, or provide any argument or
explanation in response to my Order to Show Cause, as to the onset of her GBS and why
her Table claim should be not be dismissed. Accordingly, I find there is not preponderant
evidence to establish that Petitioner suffered the first symptom or manifestation of onset
of GBS within 3 – 42 days of her flu vaccination as required by the Vaccine Injury Table.
42 C.F.R. § 100.3(a)(XIV)(D). Specifically, I find the onset of petitioner’s GBS began on
December 22, 2018. Accordingly, Petitioner’s Table Claim for GBS is dismissed.

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    V.       Scheduling Order

        I will convene a status conference forthwith to discuss further proceedings in
this case. However, Petitioner is advised that given my finding that the onset of
Petitioner’s GBS occurred on December 22, 2018 (over 70 days – or ten weeks - after
her flu vaccination), Petitioner is unlikely to establish causation in this case even for a
non-Table claim, since a timeframe of ten weeks has never been deemed medically
acceptable for vaccine-caused GBS. As I have previously noted in another GBS claim,
“other special masters have never gone beyond a two-month (meaning eight week)
interval in holding that a vaccination caused a demyelinating illness.” Barone v. Sec'y of
Health & Human Servs., No. 11-707V, 2014 WL 6834557, at *13 (Fed. Cl. Spec. Mstr.
Nov. 12, 2014) (citing Aguayo v. Sec'y of Health & Human Servs., No. 12–563V, 2013
WL 441013, at *3 (Fed. Cl. Spec. Mstr. Jan. 15, 2013); Corder v. Sec'y of Health & Human
Servs., No. 08–228V, 2011 WL 2469736, at *27–*29 (Fed. Cl. Spec. Mstr. May 31, 2011)
(proposed four month onset period from vaccination to GBS too long; two months is
longest reasonable timeframe)). This means even a non-Table claim, not subject to the
same strict requirements as a comparable Table claim, is also highly likely to prove
unfruitful.
      As a result, Petitioner should strongly consider seeking dismissal of what remains
of her case. The Vaccine Guidelines provide guidance on how to exit the Vaccine
Program. 5

IT IS SO ORDERED.

                                            s/Brian H. Corcoran
                                            Brian H. Corcoran
                                            Chief Special Master

5
  The Vaccine Guidelines can be found at http://www.uscfc.uscourts.gov/sites/default/files/Guidelines-4.24.2020.pdf
(last visited January 13, 2021).

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