Court Opinion

ID: 6351151
Source: CourtListenerOpinion
Date Created: 2022-06-20 13:01:31.553869+00
Date Added: 2024-06-11T12:47:35.803642
License: Public Domain

In the United States Court of Federal Claims
                                  OFFICE OF SPECIAL MASTERS
                                          No. 19-0890V
                                         UNPUBLISHED

    L.M.,                                                      Chief Special Master Corcoran

                         Petitioner,
    v.                                                         Filed: May 12, 2022

    SECRETARY OF HEALTH AND                                    Special Processing Unit (SPU);
    HUMAN SERVICES,                                            Findings of Fact; Ruling on
                                                               Entitlement; Influenza (Flu); Shoulder
                        Respondent.                            Injury Related to Vaccine
                                                               Administration (SIRVA).

Danielle Anne Strait, Maglio Christopher & Toale, PA, Seattle, WA, for Petitioner.

Jennifer Leigh Reynaud, U.S. Department of Justice, Washington, DC, for Respondent.

                                     RULING ON ENTITLEMENT1

       On June 18, 2019, L.M. filed a petition for compensation under the National
Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”)
alleging that she suffered a left shoulder injury related to vaccine administration (“SIRVA”)
as a result of an influenza (“flu”) vaccine administered to her on December 9, 2016.
Petition, ECF No. 1 at 1, 4. The case was assigned to the Special Processing Unit of the
Office of Special Masters.

1 Because this unpublished opinion contains a reasoned explanation for the action in this case, I am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 opinion 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).
      For the reasons discussed below, I find that a preponderance of evidence supports
the conclusion that Petitioner’s pain and reduced range of motion were limited to her left
shoulder, and that Petitioner is otherwise entitled to compensation for a left SIRVA.

  I.       Relevant Procedural History

       After initiating her claim, Petitioner filed additional records and an amended
statement of completion in June 2019. ECF Nos. 6-7. During the winter and spring of
2020, Respondent filed status reports stating that additional time was needed to conduct
a medical review of this case and expressing his inability to articulate his position on the
merits. ECF Nos. 15, 19. On May 12, 2020, Respondent formally requested an additional
90 days to indicate how he intended to proceed in this case. ECF No 21. In addition to
noting her objection, Petitioner filed a motion for a ruling on the record regarding
entitlement (“Motion”) on May 13, 2020. ECF Nos. 22, 23.

       Respondent’s request for additional time was denied, and a ruling on Petitioner’s
Motion was deferred. ECF No. 24; Non-PDF order, dated May 15, 2020. On May 27,
2020, Respondent filed a status report indicating that no “factual or legal issues that
require additional support or further factual development” had been identified by his
counsel. ECF No. 25. Finally, on July 29, 2020, Respondent completed his formal review
of the claim and invited settlement discussions. ECF No. 26. The parties spent the next
several months attempting to settle this case, but Petitioner later filed a status report
informing me that their efforts proved unsuccessful. ECF No. 35. After a status conference
on February 18, 2021, Petitioner was ordered to file her renewed motion for a ruling on
the record regarding entitlement (“Amended Motion”). ECF No. 36.

       On February 22, 2021, Petitioner filed her Amended Motion contending that she
met her burden of proof for both a Table SIRVA and off-Table claim based on the medical
records. ECF No. 37. Respondent filed his response (“Response”) on April 7, 2021. ECF
No. 39. In it, he argues that Petitioner is not entitled to compensation for SIRVA because
her pain was not limited to her vaccinated shoulder. Id. Petitioner filed her reply on April
21, 2021. ECF No. 40.

 II.       Relevant Factual Evidence

      I have fully reviewed the evidence, including all medical records, medical literature,
and the parties’ briefing. I find most relevant the following:

       •   Petitioner received a flu shot in her left deltoid on December 9, 2016. Ex. 1; Ex. 4
           at 20; Ex. 8.

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•   On December 19, 2016 (10 days post-vaccination), Petitioner telephoned her
    primary care provider. Ex. 4 at 71-72. She reported that she experienced soreness
    and numbness in her left hand shortly after receiving the flu shot on December 9,
    2016. Id. Petitioner further reported that although these symptoms subsided after
    three days, there was bruising at the injection site and her left shoulder was sore.
    Id. at 72.

•   Petitioner presented to her primary care provider on December 22, 2016, with
    complaints of left shoulder pain following receipt of a flu shot. Ex. 4 at 86-87. The
    medical notes from this visit indicate that although Petitioner reported shoulder
    pain as well as numbness and tingling down her arm after the vaccination, “the
    numbness and tingling has since resolved[,] but the left shoulder is still stiff and
    when adducted across her body[,] she feels pain ‘deep’ in her left shoulder.” Id. at
    87. It was further indicated that “[d]uring the injection[,] the MA noticed the plunger
    on the syringe injected rather quickly and alerted the MD at the time.” Id.

•   A January 9, 2017 telephone contact summary, drafted by Nurse Practitioner
    (“NP”) Terece Hahn, documents Petitioner’s report of continued left arm pain. Ex.
    4 at 119. NP Hahn’s progress note reflects that “[Petitioner’s December 9, 2016]
    injection event will be documented . . . due to the iatrogenic cause of the pain.” Id.
    at 120. She further noted that “[i]njury mechanism and history is presumed to be
    inflammatory in nature but due to the longevity and severity of the presentation of
    injury, further work up is indicated.” Id.

•   Petitioner presented to Dr. Heather Readhead for continued left shoulder pain on
    January 19, 2017. Ex. 4 at 148-176. During this visit, Petitioner described the pain
    as sharp and noted that her injury inhibited full active range of motion. Id. at 149.
    Petitioner was assessed with “vaccine related shoulder dysfunction likely
    secondary to injection of fluid into subdeltoid bursa causing periarticular
    inflammatory responses, subacromial bursitis and start of adhesive capsulitis.” Id.
    at 155, 162.

•   On February 3, 2017, Petitioner presented to Jason A. Romriell, PA-C at Northwest
    Orthopaedic Specialists. Ex. 6 at 10. PA Romriell documented Petitioner’s report
    of “pain that went all the way down her arm” immediately following her December
    2016 flu shot. Id. He further noted that “ever since then, she has had pain in her
    shoulder as well as pain radiating down into her hand. She does not describe this
    as a numbness tingling pain.” Id. PA Romriell’s impression was “left shoulder pain

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    after a vaccine” and his treatment plan included obtaining an MRI to evaluate
    Petitioner’s rotator cuff. Id.

•   Petitioner presented for a follow-up appointment with PA Romriell on February 16,
    2017. Ex. 6 at 11. The notes documenting this appointment indicate that
    Petitioner’s February 13, 2017 MRI revealed “some tendinitis and bursitis without
    any tearing.” Id. Petitioner was referred to physical therapy for “range of motion
    and strengthening exercises.” Id.

•   Petitioner underwent an initial physical therapy evaluation for “left shoulder
    discomfort” on February 23, 2017. Ex. 5 at 67. The therapist detailed Petitioner’s
    current report of “significant and consistent achiness along her anterior arm,
    however, not past elbow.” Id. She further noted that Petitioner’s range of motion
    was decreased. Id.

•   On March 30, 2017, Petitioner again presented to PA Romriell regarding her left
    shoulder. Ex. 6 at 12. Although she reported a 60-70% improvement in functionality
    and pain, PA Romriell noted that Petitioner had plateaued in the last week. Id.

•   Petitioner next presented to PA Romriell on April 27, 2017 for left shoulder pain.
    Ex. 6 at 13. She was diagnosed with left shoulder adhesive capsulitis after a
    vaccine-induced reaction and was administered an intraarticular injection of
    Celestone and lidocaine. Id.

•   The medical note documenting Petitioner’s June 1, 2017 appointment with PA
    Romriell indicates that the intraarticular injection significantly relieved Petitioner’s
    left shoulder pain. Ex. 6 at 14. Improvement of Petitioner’s range of motion was
    also noted. Id.

•   Petitioner presented to Dr. Russell VanderWilde at Northwestern Orthopaedic
    Specialists on July 27, 2017. Ex. 6 at 15. Dr. VanderWilde noted that after her
    December 2016 flu shot, Petitioner “had transient numbness, but then
    subsequently has had progressive shoulder pain and stiffness that is now getting
    better.” Id. He opined that while “[Petitioner’s] sequence of events is certainly
    unusual . . . I think it anatomically makes sense that the injection were to have
    been too close to the posterior capsule that it would cause scarring and potential
    tightness and subsequently the frozen shoulder and impingement problems.” Id.
    Dr. VanderWilde’s impression was left shoulder impingement and “left shoulder
    generalized internal rotation deficit and capsulitis, triggered after a vaccine
    injection.” Id.

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   •   The medical note documenting Petitioner’s January 25, 2018 follow-up
       appointment with Dr. VanderWilde indicates that Petitioner was concerned about
       nerve injury and abnormal scapular mechanic. Ex. 6 at 6. On exam, Petitioner was
       found to have “nearly full” range of motion “with slight loss of internal rotation.” Id.
       Dr. VanderWilde also noted that while Petitioner’s “[e]xiting nerve” was intact, she
       had “subtle scapular winging.” Id.

   •   On July 12, 2018, Petition returned to Dr. Russell VanderWilde regarding her left
       shoulder pain. Ex. 6 at 3-5. Petitioner shared that her pain worsened after
       participating in physical therapy and noted a “catching sensation” with certain
       movements. Id. at 4. Petitioner was assessed with adhesive capsulitis, a glenoid
       labrum tear, and shoulder pain. Id.

   •   Petitioner underwent a left shoulder arthrogram on September 4, 2018. Ex. 4 at
       716-17. It revealed “significant improvement in the amount of edema within the
       infraspinatus muscle and tendon as well as imagining improvement in the degree
       of subacromial/subdeltoid bursitis,” when compared to Petitioner’s February 2017
       MRI. Id. 716.

   •   On October 4, 2018, Petitioner returned to Dr. VanderWilde regarding her left
       shoulder pain. Ex 4 at 629-630. His impression was “[l]eft shoulder pain after a
       vaccine with a history of a frozen shoulder with good motion at this point.” Id. at
       630. Treatment options included the performance of a left shoulder scope and
       “debridement of the fraying of her labrum.” Id. Petitioner was advised to follow up
       as needed. Id.

III.   Authority

        Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the petition by Vaccine Act
Section 11(c)(1). A Petitioner may prevail on her claim if she 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 a claimant establishes that she has
suffered a “Table Injury,” causation is presumed.

       Section 11(c)(1) also contains requirements concerning the type of vaccination
received and where it was administered, the duration or significance of the injury, and the

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lack of any other award or settlement. See Section 11(c)(1)(A), (B), (D), and (E). With
regard to duration, a petitioner must establish that she suffered the residual effects or
complications of such illness, disability, injury, or condition for more than six months after
the administration of the vaccine. Section 11(c)(1)(D).

       Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed
on the Vaccine Injury Table. See Vaccine Injury Table: Qualifications and aids to
interpretation. 42 C.F.R. § 100.3(c)(10). The criteria are as follows:

       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).
Id.

IV.    Findings of Fact Regarding Scope of Pain and Limited Range of Motion

       Respondent argues that Petitioner has failed to establish that she suffered a Table
injury because her symptoms were not limited to her left shoulder. Response at 6. He
asserts that Petitioner “constantly described soreness or pain that radiated down her left
arm and into her hand after receiving her flu vaccine.” Id (emphasis added).

        I find, however, that (for purposes of the Table SIRVA claim), a preponderance of
evidence supports the conclusion that Petitioner’s injury was limited to her left shoulder,
even if pain elsewhere in the arm is documented. Petitioner’s medical records consistently
document shoulder pain and reduced range of motion, which are specific,
contemporaneous evidence consistent with other SIRVA cases. See, e.g., Ex. 4 at 87
(December 22, 2016 medical note documenting Petitioner’s complaint of deep pain with
shoulder adduction); Ex. 5 at 67 (February 23, 2017 physical therapy note reflecting
Petitioner’s report of immediate post-vaccination shoulder discomfort and soreness); Ex.
6 at 6 (January 25, 2018 orthopedic note detailing the continuation of Petitioner’s left
shoulder pain).

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        Respondent correctly identifies references to soreness and numbness in
Petitioner’s left hand in the immediate aftermath of vaccination, as well as pain that
extended down her arm. Ex. 4 at 72; Ex. 6 at 10, 15. However, while these symptoms
were described as transient, Petitioner’s left shoulder pain was consistent. See, e.g., Ex.
4 at 87 (December 22, 2016 medical note indicating that while Petitioner’s initial report of
shoulder pain was accompanied by complaints of arm numbness and tingling, “[t]he
numbness and tingling have since resolved “leaving lingering shoulder pain and
stiffness.”). Moreover, the medical records reflect that Petitioner’s treatment was focused
on her shoulder symptoms. See, e.g., Ex. 6 at 10 (February 3, 2017 treatment plan
detailing MRI testing and evaluation of Petitioner’s rotator cuff); Id. at 11 (February 16,
2017 referral to physical therapy for range of motion and strengthening exercises after a
finding of left shoulder impingement with tendinitis and bursitis); Id. at 13 (April 27, 2017
orthopedic note detailing the administration of an intraarticular injection to address
Petitioner’s left shoulder pain and stiffness). And pain that is not reasonably associated
with Petitioner’s SIRVA can be disregarded in determining damages in this case.

        Accordingly, preponderant evidence establishes that Petitioner’s pain was
sufficiently “limited” to her left shoulder for a favorable ruling on this SIRVA element.

 V.    Other Table Requirements and Entitlement

       1. Prior Condition

      The first QAI requirement for a Table SIRVA is lack of a history revealing problems
associated with the affected shoulder which were experienced prior to vaccination and
would explain the symptoms experienced after vaccination. 42 C.F.R. § 100.3(c)(10)(i).

       Respondent has not contested that Petitioner has met the first requirement under
the QAI for a Table SIRVA. Additionally, I do not find any evidence that Petitioner suffered
a pre-vaccination history of problems that would explain her post-vaccination shoulder
symptoms. Accordingly, I find that Petitioner has met this first criterion to establish a Table
SIRVA.

       2. Onset

        A petitioner alleging a SIRVA claim must also show that she experienced the first
symptom or onset within 48 hours of vaccination (42 C.F.R. § 100.3(a)(XIV)(B)), and that
her pain began within that same 48-hour period (42 C.F.R. § 100.3(c)(10)(ii) (QAI
criteria)).

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       Respondent does not dispute Petitioner has met this requirement. Additionally, I
find that the evidence collectively establishes that her shoulder pain began within 48
hours of receiving the December 9, 2016 flu vaccine. There is no counterevidence
undercutting Petitioner’s contention that her pain began close-in-time to vaccination, and
she consistently attributed his shoulder pain to the flu shot. See, e.g., Ex. 4 at 71
(December 19, 2016 telephone record noting that Petitioner’s symptoms “have been
going on [since] the date of the shot 12/9.”); Ex. 6 at 10 (orthopedic record noting that
Petitioner “went in for a flu vaccine and immediately had pain.”). Accordingly, I find that
Petitioner has met this criterion to establish a Table SIRVA.

       3. Other Condition or Abnormality

       The last QAI criteria for a Table SIRVA states that there must be no other condition
or abnormality which would explain a petitioner’s current symptoms. 42 C.F.R. §
100.3(c)(10)(iv). Respondent has not contested that Petitioner meets this criterion, and
there is no evidence in the record to the contrary. Thus, the record contains preponderant
evidence establishing that there is no other condition or abnormality which would explain
the symptoms of Petitioner’s left shoulder injury.

       4. Other Requirements for Entitlement

       Even if a petitioner has satisfied the requirements of a Table injury or established
causation-in-fact, he or she must also provide preponderant evidence of the additional
requirements of Section 11(c), i.e., receipt of a covered vaccine, residual effects of injury
lasting six months, etc. See generally § 11(c)(1)(A)(B)(D)(E). But those elements are
established or undisputed.

      Thus, based upon all of the above, Petitioner has established that she suffered a
Table SIRVA, satisfying all other requirements for compensation.3

VI.    Conclusion

    Based on the entire record, I find that Petitioner has provided preponderant evidence
satisfying all requirements for a Table SIRVA. Petitioner is entitled to compensation. A
subsequent order will set further proceedings towards resolving damages.

3Because I have found that Petitioner has demonstrated a Table injury, there is no need to address
Petitioner’s “causation-in-fact” allegation.

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IT IS SO ORDERED.
                        s/Brian H. Corcoran
                        Brian H. Corcoran
                        Chief Special Master

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