Court Opinion

ID: 7802230
Source: CourtListenerOpinion
Date Created: 2022-08-19 21:02:14.143099+00
Date Added: 2024-06-11T16:29:25.708334
License: Public Domain

CORRECTED

    In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                           No. 20-0209V
                                          UNPUBLISHED

    TRACY SUE BEACH,                                            Chief Special Master Corcoran

                         Petitioner,                            Filed: July 11, 2022
    v.
                                                                Special Processing Unit (SPU);
    SECRETARY OF HEALTH AND                                     Dismissal; Insufficient Evidence;
    HUMAN SERVICES,                                             Influenza (Flu) Vaccine; Shoulder
                                                                Injury Related to Vaccine
                         Respondent.                            Administration (SIRVA)

Maximillian J. Muller, Muller Brazil, Dresher, LLP, PA, for Petitioner.

James Vincent Lopez, U.S. Department of Justice, Washington, DC, for Respondent.

                                                 DECISION1

       On February 26, 2020, Tracy Sue Beach 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, which was caused-in-fact by the
influenza (“flu”) vaccine she received on October 11, 2017. Petition at 1, ¶¶ 2, 9.

      However, the medical record establishes that Petitioner described two
substantially different shoulder injuries and accompanying symptoms – the first
immediately upon vaccination, and the second more than one-year post-vaccination.

1  Because this unpublished Decision contains a reasoned explanation for the action in this case, I am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 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.

2National 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).
Because she has failed to provide preponderant evidence to support or to link either
claimed injury, I hereby DENY entitlement in this case.

          I.     Relevant Procedural History

       Along with the Petition, Ms. Beach filed her affidavit and the medical records
required under the Vaccine Act. Exhibits 1-13; Section 11(c). The case was assigned to
SPU on May 22, 2020. ECF No. 9.

       At the initial status conference, held on August 4, 2020, the parties discussed
several issues with this case. ECF No. 12. Specifically, it appeared the medical records
contained confusing evidence which did not support Petitioner’s allegations, and the
Petition contained several instances of incorrect medical records citations. Id. at 1. On
September 29, 2020, Petitioner filed an affidavit from her trainer providing his
recollections from October 2017 to support Petitioner’s claims of onset (Exhibit 14, ECF
No. 13), an amended petition with corrected medical records citations (ECF No. 14), and
a status report indicating that initially Petitioner was informally treated by her sister - a
registered nurse, in October 2017 (ECF No. 15).

       On July 7, 2021, Respondent filed his Rule 4(c) Report opposing compensation.
ECF No. 21. Respondent argued that Petitioner has not satisfied the criteria for a Table
SIRVA injury or provided preponderant evidence of causation. Rule 4(c) Report at 6-7.
Specifically, Petitioner’s injury did not meet requirements related to onset, the location of
pain and range of motion (“ROM”), and the absence of an alternative cause for a Table
SIRVA claim. Rule 4(c) Report at 5-6; see 42 C.F.R. § 100.3(a)(XIV) & (c)(ii) - (iv) (2017)
(setting forth these SIRVA requirements). Regarding Petitioner’s causation-in-fact claim,
Respondent noted that “[n]one of [P]etitioner’s physicians causally related her complaints
to her flu vaccination, and [P]etitioner has not submitted an expert report or any other
evidence to establish that the flu vaccination caused her alleged SIRVA.” Id. at 7 (citing
the three-pronged test for causation set forth in Althen v. Sec’y of Health & Hum. Servs.,
418 F.3d 1274, 1278 (Fed. Cir. 2005)).

       On January 18, 2022, I issued an Order to Show Cause, allowing Petitioner a final
chance to obtain and to file the evidence needed to support her allegations. ECF No. 22.
Although I was not persuaded by Respondent’s arguments regarding onset (id. at 3), I
determined that Petitioner had failed to provide sufficient evidence to satisfy the other
requirements for a Table SIRVA claim, due to the location of her pain and the existence
of potential alternative causes, or to support a non-Table version of the claim. Id. at 5.

      In response, Petitioner filed additional evidence addressing primarily the onset
issue which Respondent raised – a supplemental affidavit; documentation showing

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Petitioner procured medical insurance providing coverage from September 6, 2018, to
March 17, 2019; a patient history and occupational health assessment from late June
2018; a written response; and a status report indicating the case did not involve a workers’
compensation claim. Exhibits 15-17, ECF Nos. 24-25; Petitioner’s Brief in Response to
Order to Show Cause (“Response”), ECF No. 26; Status Report, ECF No. 27. In the
written response, she dedicated a large portion of her argument to the issue of onset.
Response at 8-11.

        When discussing the other deficiencies I noted, Petitioner failed to acknowledge
the differences between the symptoms Petitioner reported in late 2017 and early 2018
and those she complained of in December 2018. Response at 11-16. She simultaneously
emphasized the lack of evidence for a neurologic injury while relying on her earlier
statement of radiating pain which she attributed to the vaccine hitting a nerve. Id. at 11-
14. To support her claim of a logical cause and effect between vaccination and pain, she
relied upon the timing of her initial symptoms and what she characterized as a lack of an
alternative cause. Id. at 14-15.

        Following a May 3, 2022 telephonic status conference, I instructed Petitioner to
consider whether she wished to proceed based upon only the neurologic injury she
described immediately post-vaccination through June 2018, or to provide further evidence
linking the more traditional SIRVA symptoms she later reported in association with this
earlier injury. Order, issued May 10, 2022, at 2, ECF No. 28. I cautioned that any physician
statements regarding causation should clearly indicate that the treating physician has
reviewed all relevant medical records before reaching any conclusion. Id. In response,
Petitioner filed a status report indicating she “is unable to obtain any additional evidence
as described in the Scheduling Order of May 10, 2022.” ECF No. 29.

       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:

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       Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests
       as shoulder pain and limited range of motion occurring after the
       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 v. Sec’y of Health & Hum. Servs., 418 F.3d
1274, 1279-80 (Fed. Cir. 2005) (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

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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. Cir 1999). Id. at 1352. The
received vaccine, however, need not be the predominant cause of the injury. Id. at 1351.

        The Circuit Court 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
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 & 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

        To support his assertion that Petitioner has failed to establish that the onset of her
pain occurred within 48 hours of vaccination, Respondent emphasizes the more than six-
month delay between Petitioner’s vaccination and the date she first sought medical
treatment, plus information contained in a Facebook message Petitioner sent to her
trainer. Rule 4(c) Report at 2. Stressing that Petitioner received immunizations and TB

                                              5
tests on numerous occasions prior to vaccination, he characterizes Petitioner’s rationale
for the delay in treatment - that she was uninsured at the time - as not credible. Id.

       However, and as I previously stated, I do not find Respondent’s onset objections
to be persuasive. The cost of an immunization or TB test, often required for employment,
is undoubtedly less than a visit for an illness or injury – and hence it is not unreasonable
for a petitioner to avoid the greater cost of an actual doctor’s visit. Additionally, in the
same October 19, 2017 Facebook message at issue (containing the description of three
days of pain upon which Respondent relies), Petitioner clearly attributes her injury to the
flu vaccine she received. Exhibit 10 at 1. And if Petitioner is counting the date of
vaccination/onset as well as the date of the message, her description of a three-day
duration for her pain is accurate.

         But deciding the above issue in Petitioner’s favor does not resolve the present
dispute. More problematic are the issues related to the nature and cause of Petitioner’s
reported symptoms. When Petitioner first complained of left shoulder pain, she described
symptoms above her shoulder and radiating to her fingers – all of which appear more
neurological in nature. Thus, in the Facebook message to her trainer, Petitioner described
a stiff neck along with an inability to turn her head, headache, and knot in her arm. Exhibit
10 at 1. Later that day, she indicated that she had “a little more range of motion in [her]
neck tonight,” adding that her “instructor[ ] said today that they possibly hit a nerve.” Id.
at 2. Five days later, she reported that she had her injury “checked out and [her] C5 nerve
was hit by the needle…she gave me the shot too low below the deltoid.” Id. at 3. She
described her pain as “radiat[ing] clear up [her] neck n [sic] into [her] head …causing
migraine-like pain.” Id. at 4. Petitioner further reported that her mother previously had the
same type of injury which improved after physical therapy (“PT”). Id. at 3. In a status
report, filed on March 2, 2021, Petitioner indicated that her sister, a registered nurse, was
the individual who examined her during his time. ECF No. 18.

       Petitioner did not otherwise seek treatment until late April 2018, when she was
seen at the Knox Country Community Health Center, complaining of “numbness, tingling,
and pain in the left shoulder radiating down into her fingers since having a flu shot last
October.” Exhibit 13 at 13. Her prior history of trigeminal neuralgia is noted in the record
from this visit. Id.; see also Exhibit 3 at 8-12 (regarding a 2015-16 complaint of right-sided
facial pain and left-sided Bells Palsy seven to eight years earlier). It appears she
continues to take Gabapentin for this prior pain. Exhibit 11 at 6, 9-10.

        On May 11, 2018, Petitioner visited the neurologist who had treated her 2015-16
facial pain, complaining of left shoulder pain which radiated into her hand. Exhibit 3 at 21-
23. She reported that pain which had radiated into her neck had resolved. Id. at 21. An
EMG was ordered. Id. at 23. Performed on June 11, 2018, the EMG revealed no evidence

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of “cervical radiculopathy, brachial plexopathy, or ulnar neuropathy” and only incidental
electrodiagnostic evidence of “left median nerve entrapment at the wrist.” Id. at 24.

        As I previously indicated in my January 18, 2022 Order to Show Cause, nerve-
related injuries such as that Petitioner initially described have been compensated in the
Vaccine Program, although as causation-in-fact claims, rather than Table SIRVA claims.
See, e.g., Kirby v. Sec’y of Health & Hum. Servs., No. 16-0185V, 2019 WL 6336026 (Fed.
Cl. Spec. Mstr. May 27, 2020), review granted, decision rev'd on other grounds, 148 Fed.
Cl. 530 (2020), reinstated 997 F.3d 1378 (Fed. Cir. 2021). However, in this case there is
significant evidence which undercuts a non-Table claim. By May 11th, Petitioner’s
upwardly radiating pain had resolved, and she reported only pain traveling into her left
hand. The subsequent June 2018 EMG revealed only incidental findings related to
Petitioner’s left wrist, and otherwise normal results. And Petitioner has a history of facial
pain, for which she was still taking Gabapentin.

        Following the June 11, 2018 EMG, Petitioner did not seek medical treatment for
left shoulder pain until December 2018. Exhibit 4 at 5-7. During that six-month period, she
was seen for a lower back injury sustained while lifting a patient in October 20183 –
attending four PT sessions to treat this pain, and an upper respiratory illness in November.
Exhibit 11 at 6-14; Exhibit 12 at 4-15. There is no mention of left shoulder pain in the
records from these visits. Id. And in her PT records, it is specifically noted that Petitioner
had pain only in her lower left back. Exhibit 12 at 6, 10-11, 13-14.

       On December 17, 2018, Petitioner was seen by an orthopedist, complaining of left
shoulder soreness and decreased ROM which she attributed to the flu vaccine she
received fourteen months earlier. Exhibit 4 at 5. She described her pain as a dull ache -
located over the lateral aspect of her left arm and aggravated by physical activity. Id.
Although these symptoms are typical of those usually reported following a SIRVA injury,
Petitioner did not provide this account until more than a year post-vaccination.
Additionally, she reported that she had undergone PT which failed to alleviate her pain –
an allegation not supported by the record in this case.

        Additionally, x-rays, performed that day, showed mild ossification, calcification,
and moderate osteoarthritis. Exhibit 4 at 14. An MRI, performed on January 11, 2019,
showed the same ossification, a globular calcium deposit in the distal supraspinatus
tendon consistent with moderate calcific tendinitis, no rotator cuff tear or edema, and mild
joint osteoarthritis and subacromial/subdeltoid bursitis. Id. at 13. Petitioner attended four

3 Petitioner described having her right arm under the patient’s armpit while attempting a two-person lift,
trying to avoid spilling hot liquid (soup) on the patient’s chest. Exhibit 11 at 9.

                                                    7
acupuncture sessions in February and March 2019. Exhibit 5 at 2-4. Other than a TB test
from April 2019 (Exhibit 11 at 4-5), no further medical records have been filed.

       When filing her petition, Petitioner provided affidavits from her parents and sister.
Exhibits 7-9. Although these affidavits provide further support for Petitioner’s onset
claims, they do not address the more problematic deficiencies in Petitioner’s case
discussed above.

       Petitioner has provided two differing accounts of left shoulder pain. Her initial pain
appeared to be neurologic, centered in her neck and accompanied by a severe headache.
However, based upon the record as it currently stands, there is insufficient evidence of
causation for this earlier neurologic injury which confers the timing needed to establish
an appropriate onset. And, considering that the upwardly radiating pain Petitioner initially
reported did not appear to be present in late April 2018, and was reported to be resolved
by May 11th, the record as it currently stands does not support a finding of six months of
sequelae based upon only this earlier described injury.

       After testing revealed a lack of support for a neurological condition, Petitioner did
not seek additional treatment for this radiating pain. When seen by an orthopedist six
months later, following a period when she sought medical treatment for other conditions
and failed to report any left shoulder pain, Petitioner reported a different type of pain - a
dull ache over her later shoulder. She had not previously reported these symptoms. And
testing revealed other potential causes of this new pain, such as moderate calcific
tendinosis and mild joint osteoarthritis. Unless these later symptoms can be linked to the
injury Petitioner initially described, it is unlikely that Petitioner could establish the
appropriate required causal link and timing for a vaccine-related injury.

       It was conceivable that these claim inconsistencies could be resolved with
evidence – whether provided by an expert, medical literature, or the record itself.
Petitioner was provided with the opportunity to provide additional evidence and argument
regarding this shortcoming - but declined to do so. She also failed to indicate whether she
wished to continue based solely upon her earlier injury or wished to provide further
evidence to link the differing symptoms. Accordingly, I cannot find on the record as it
stands that either a Table SIRVA claim, or non-Table claim for some other distinguishable
form of neuropathic injury, could be sustained.

          IV.    Conclusion

      To date, and despite ample opportunity, Petitioner has failed to provide
preponderant evidence to support her allegation of a left shoulder injury caused by the flu
vaccine she received on October 11, 2017. Petitioner was informed that failure to provide

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preponderant 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 for failure to prosecute and insufficient evidence. The Clerk of
Court shall enter judgment accordingly.4

IT IS SO ORDERED.

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

4 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.

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