Johnson v. Secretary of Health and Human Services ( 2021 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-1092V
UNPUBLISHED
PAULA JOHNSON, Chief Special Master Corcoran
Petitioner, Filed: May 14, 2021
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Findings of Fact; Onset; Influenza
HUMAN SERVICES, (Flu) Vaccine; Guillain-Barré
Syndrome (GBS)
Respondent.
Emily Beth Ashe, Anapol Weiss, Philadelphia, PA for Petitioner.
Naseem Kourosh, U.S. Department of Justice, Washington, DC, for respondent.
DECISION DISMISSING CASE 1
On August 28, 2020, Paula Johnson 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 that she suffered Guillain-Barré syndrome (“GBS”) that
was caused in fact by an influenza (“flu”) vaccine received on September 11, 2018.
Petition at 1. This case was assigned to the Special Processing Unit of the Office of
Special Masters.
On April 2, 2021, Petitioner was ordered to show cause why this case should not
be dismissed for insufficient proof. ECF No. 18. Petitioner filed a response on May 3,
2021. ECF No. 20. For the reasons discussed below, this claim is hereby DISMISSED.
1
Although I have not formally designated this Decision for publication, I am required to post it on the United
States Court of Federal Claims' website because it contains a reasoned explanation for the action in this
case, 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 Decision will be
available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has
14 days to identify and move to redact medical or other information, the disclosure of which would constitute
an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this
definition, I will redact such material from public access.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. 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).
I. Procedural History
This case was initiated on August 28, 2020. ECF No. 1. Petitioner filed medical
records on October 8, 2020, and December 30, 2020, ultimately filing a statement of
completion on December 30, 2020. ECF Nos. 7, 12, 13.
During an initial status conference, the staff attorney assigned to this case
conveyed my initial thoughts regarding potential onset issues. In particular, the records
indicated that Petitioner’s first symptoms appeared no sooner than 92 days after her
vaccination. ECF No. 18. This would put Petitioner’s claim outside the longest time
accepted for a causation-in-fact flu/GBS claim (and well outside the Table’s timeframe of
3-42 days). For those reasons, I directed Petitioner to show cause why this claim should
not be dismissed. ECF No. 18.
Petitioner filed her response to the order to show cause on May 3, 2021. ECF No.
20. Petitioner reported that there were no additional medical records, and respectfully
requested a ruling on entitlement based on the existing filed records.
II. Factual Background
Petitioner received a flu vaccine on September 11, 2018. Ex. 1 at 4. On December
12, 2018, 92 days after her vaccination, she reported sudden onset numbness in her
lower extremities. Ex. 2 at 1506, Ex. 14 (Affidavit of Paula Johnson) at 1. Petitioner
specifically stated that she had experienced the numbness since 5 p.m. of that day. Id.
Petitioner underwent a series of diagnostic scans and a lumbar puncture on December
13, 2018. Id. at 1514-1519, 1242. Despite normal protein levels obtained from a lumbar
puncture (id. 1242 and 1300-1317), based on her presentation and neurological exam,
Petitioner was found to possibly have GBS, 3 and received five doses of IVIG. Id. at 1421-
22. She showed some improvement, but was still “very symptomatic” after the IVIG
treatment. Id. at 1423.
Petitioner was discharged to a rehabilitation facility on December 19, 2018, where
she stayed until January 3, 2019. Ex. 2 at 695. Her diagnoses at discharge included GBS.
Id. Petitioner treated symptoms such as incontinence, balance and gait problems,
numbness, and weakness of her lower extremities in the following months, and was
provided with a “cannot return to work” letter on March 26, 2019. Ex. 5. She continued to
work with her treating physicians and physical therapists until at least February 20, 2020,
when she was discharged from physical therapy and advised to continue with a home
3
Petitioner’s differential diagnosis also included transverse myelitis. Ex. 2 at 1422.
2
exercise program. Ex. 6 at 15-18. Due to lingering symptoms, Petitioner continues to treat
her urinary and neurological issues. See Petition at 12.
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 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 influenza
vaccination. 42 C.F.R. § 100.3(a)(XIV)(D). (Further criteria for establishing a GBS Table
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).
3
Injury case be found under the accompanying qualifications and aids to interpretation. 42
C.F.R. § 100.3(c)(15)). Any onset outside that timeframe prevents the matter from
succeeding as a Table claim, although it can often still be maintained as a non-Table,
causation-in-fact claim.
Cases alleging a Table GBS/flu vaccine claim are readily dismissed for failure to
establish the 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”). Further, in adjudicating non-Table
versions of such a claim, special masters have frequently noted that six to eight weeks
is the longest medically acceptable timeframe for onset of GBS following a flu vaccine.
See, e.g., Chinea v. Sec'y of Health & Human Servs., No. 15-095V, 2019 WL 1873322,
at *33 (Fed. Cl. Mar. 15, 2019), mot. for review den’d, 144 Fed. Cl. 378 (2019) (finding
that the onset of the petitioner’s GBS occurred eleven to twelve weeks after her
vaccination, well beyond the six- to eight-week medically appropriate timeframe for the
occurrence of vaccine-induced GBS); Barone v. Sec’y of Health & Human Servs., No.
11-707V, 2014 WL 6834557, at *13 (Fed. Cl. Spec. Mstr. Nov. 12, 2014) (finding eight
weeks (56 days) is the longest reasonable timeframe for a flu vaccine/GBS 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.
Petitioner alleges that she suffered from GBS that was caused-in-fact by a flu
vaccine administered on September 11, 2018. Petition at 2. She thus does not attempt
to argue that her onset fell within the Table’s 3-42 day timeframe, as the petition alleges
that the onset of her symptoms occurred on December 12, 2018. Id. Petitioner’s affidavit
and contemporaneous medical records preponderantly establish that the initial
symptoms occurred on December 12, 2018. Ex. 2 at 1506, Ex. 14 at 1. This puts the
onset of Petitioner’s GBS at 92 days after her vaccination.
Such facts not only put Petitioner’s claim outside the 42-day limit for a viable
Table flu-GBS claim, but outside the longest time accepted for a similar non-Table
claim. See, e.g., Williams v. Sec'y of Health & Hum. Servs., No. 19-1177V, 2021 WL
815921, at *2 (Fed. Cl. Jan. 19, 2021) (onset of GBS over 100 days after a flu vaccine
was fatal to even a non-Table claim); Chinea, 2019 WL 1873322 at *33 ; Barone, 2014
WL 6834557 at *13.
4
Despite ample opportunity, Petitioner has failed to show cause, or provide any
argument or explanation in response to my Order to Show Cause, as to why her claim
should not be dismissed. Accordingly, I find the onset of petitioner’s GBS began on
December 12, 2018. I also find that the present facts cannot support a causation-in-fact
claim, since an onset of more than ten weeks has never been deemed medically
acceptable. Barone, 2014 WL 6834557, at *13. Petitioner has not otherwise offered any
evidence that would suggest this onset “yardstick” should not be followed in this case.
V. Conclusion
The evidentiary record does not support Petitioner’s contention that the flu
vaccine she received in September 2018 caused her GBS, because her onset cannot
be demonstrated as medically acceptable under the third prong of the test set forth in
Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
Therefore I must DISMISS Petitioner’s claim in its entirety. The clerk shall enter
judgment accordingly. 5
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
5
If Petitioner wishes to bring a civil action, he must file a notice of election rejecting the judgment
pursuant to § 21(a) “not later than 90 days after the date of the court’s final judgment.”
5