Wotila v. Secretary of Health and Human Services ( 2024 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 23-0371V
JOYA WOTILA,
Chief Special Master Corcoran
Petitioner,
v. Filed: October 25, 2024
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Jonathan Joseph Svitak, Shannon Law Group, P.C., Woodridge, IL, for Petitioner.
Nathaniel Trager, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION DISMISSING CASE1
On March 14, 2023, Joya Wotila 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 a left shoulder injury related to vaccine
administration (“SIRVA”), a defined Table Injury, after receiving a tetanus-containing 3
vaccine on February 8, 2021. Petition at 1, ¶¶ 2, 15-16.
However, the record in this case contains insufficient evidence to establish the pain
onset within the timeframe required for a Table SIRVA, or even to support any causal link
1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made
publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (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 (2018).
3 The vaccine record in this case reveals Petitioner specifically received a tetanus, diphtheria, acellular
pertussis (“Tdap”) vaccine. Ex. 2 at 1.
between Petitioner’s left shoulder pain and the vaccination she received. See 42 C.F.R.
§ 100.3(a)XIV(B) & (c)(10)((ii) (2017) (requiring pain onset within 48 hours of vaccination);
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (three-
pronged test for actual causation). And despite due opportunity, Petitioner has not
provided the preponderant evidence needed to overcome these deficiencies. I therefore
DENY entitlement in this case.
I. Relevant Procedural History
Within three months of filing the Petition, Ms. Wotila filed sworn declarations from
her daughter and herself 4 and the medical records required by the Vaccine Act. Exs. 1-9;
see Section 11(c). On October 17, 2023, the case was activated and assigned to SPU.
ECF No. 15.
On July 1, 2024, Respondent filed his Rule 4(c) Report opposing compensation.
ECF No. 21. He maintains that Petitioner cannot establish pain onset within 48 hours of
vaccination. Id. at 8 (citing 42 C.F.R. § 100.3(c)(10)(ii) (second QAI criterion). Although
less clear, Respondent presents arguments related to severity and a potential non-Table
claim as well. Id. at 7-10.
On August 23, 2024, I issued an Order to Show Cause, allowing Petitioner a final
chance to obtain and file the evidence needed to support her allegations. ECF No. 23.
After receiving two extensions of time until October 18, 2024 (ECF Nos. 25-26), Petitioner
has failed to provide any additional evidence. The matter is now ripe for adjudication.
II. 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). According to the most recent version of the Table, a SIRVA is
compensable if it manifests within 48 hours of the administration of an influenza vaccine.
42 C.F.R. § 100.3(a)(XIV)(B). The specific criteria establishing a SIRVA are as follows:
Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests
as shoulder pain and limited range of motion occurring after the
4 These declarations comport with the requirements of 28 U.S.C.A. § 1746; they were signed under penalty
of perjury. Exs. 1, 9.
2
administration of a vaccine intended for intramuscular administration in the
upper arm. These symptoms are thought to occur as a result of unintended
injection of vaccine antigen or trauma from the needle into and around the
underlying bursa of the shoulder resulting in an inflammatory reaction.
SIRVA is caused by an injury to the musculoskeletal structures of the
shoulder (e.g. tendons, ligaments, bursae, etc). SIRVA is not a neurological
injury and abnormalities on neurological examination or nerve conduction
studies (NCS) and/or electromyographic (EMG) studies would not support
SIRVA as a diagnosis (even if the condition causing the neurological
abnormality is not known). A vaccine recipient shall be considered to have
suffered SIRVA if such recipient manifests all of the following:
(i) No history of pain, inflammation or dysfunction of the affected shoulder
prior to intramuscular vaccine administration that would explain the alleged
signs, symptoms, examination findings, and/or diagnostic studies
occurring after vaccine injection;
(ii) Pain occurs within the specified time frame;
(iii) Pain and reduced range of motion are limited to the shoulder in which
the intramuscular vaccine was administered; and
(iv) No other condition or abnormality is present that would explain the
patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
brachial neuritis, mononeuropathies, or any other neuropathy).
42 C.F.R. § 100.3(c)(10) (additional requirements set forth in the Qualifications and Aids
to Interpretations (“QAI”)). If a petitioner establishes that the vaccinee has suffered a
“Table Injury,” causation is presumed.
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, 418 F.3d at 1279-80 (referencing Hellebrand
v. Sec’y of Health & Hum. 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 & Hum. Servs., 165 F.3d 1344, 1351 (Fed.
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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 & Hum. Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The Circuit
adds 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 & Hum. 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
more immediate. Reusser v. Sec’y of Health & Hum. Servs., 28 Fed. Cl. 516, 523 (1993).
III. Analysis
The medical records show that despite several visits for primary care and
chiropractic treatment post-vaccination,5 Petitioner never complained of left shoulder pain
5 For example, during chiropractic visits, Petitioner sought treatment for back and neck pain which appears
to have been a continuation of symptoms she first reported in during the year prior to vaccination. On
October 4 and 11, 2020, Petitioner suffered mid to lower back pain and muscle spasms, thought to be
caused by physical labor – moving boxes in her new house. Ex. 3 at 13-18. Post-vaccination, she returned
to the chiropractor on April 22, 2021, and October 12, 2021, complaining of pain and tightness in her back
and neck. Id. at 19-27.
4
until December 1, 2021 - almost ten months after receiving the Tdap vaccine. Ex. 5 at 6;
see also Ex. 2 at 1 (vaccine record). Because she requested additional microcurrent
treatment, it appears that this pain was also present in November 2021, when Petitioner
was seen for “chronic pain and myalgia,” which she thought may be due to her recent
COVID illness. Ex. 5 at 7 (noting Petitioner agreed to microcurrent treatment).
In addition, when Petitioner did seek treatment for left shoulder pain in December
2021, she did not attribute that pain to the Tdap vaccine she had received ten months
earlier. Ex. 5 at 6. And at a chiropractic appointment on January 6, 2022, she wondered
about the source of her left shoulder pain, “stat[ing] she is not sure what happened, but
her left shoulder has been hurting to the point she is not able to function or lift anything
above her head.” Ex. 3 at 28. Furthermore, when seen by an orthopedic surgeon on
February 22, 2022 (now more than one-year post-vaccination), Petitioner reported “a six-
month history of left shoulder pain without specific injury.” Ex. 7 at 15 (emphasis added).
This history equates to a pain onset consistent with the diffuse pain Petitioner was
experiencing beginning in the fall of 2021, but more than six-months post-vaccination.
Thus, the medical records in this case do not support the conclusion that
Petitioner’s shoulder pain began within 48 hours of vaccination. Instead, they establish
that Petitioner suffered back and neck pain, likely due to physical activity, prior to and
after vaccination. Petitioner also appears to have experienced diffuse pain and myalgia
throughout her body beginning in the fall of 2021, which she theorized might be connected
to her COVID illness. Pain in her left shoulder intensified in December 2021, and she
continued to seek treatment for this condition with no mention of the Tdap vaccine in
2022.
It appears that Petitioner did not attribute her left shoulder pain to the Tdap vaccine
she received until filing the Petition in this case, more than two years post-vaccination.
Although she has provided sworn declarations from her daughter and herself to support
onset and other disputed factual issues, these documents were not signed (and thus,
likely not created) until shortly before their filing – more than four months after the initiation
of this claim. See Exs. 1, 9. As they provide the only evidence supporting an appropriate
temporal relationship, and given their non-contemporaneous quality when compared to
the filed medical records, I do not give them significant weight. Petitioner cannot prevail
pursuant to either a Table or non-Table claim.
Conclusion
To date, and despite ample opportunity, Petitioner has failed to provide
preponderant evidence to support her allegation of a left shoulder injury that meets the
definition for a Table SIRVA or was caused by the Tdap vaccine she received on February
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8, 2021. Petitioner was informed that failure to provide preponderant evidence to support
her claim would be treated as either a failure to prosecute this claim or as an inability to
provide supporting documentation for the claim. Accordingly, this case is DISMISSED.
The Clerk of Court shall enter judgment accordingly. 6
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
6 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice
renouncing the right to seek review.
6