Court Opinion

ID: 5282127
Source: CourtListenerOpinion
Date Created: 2022-01-06 22:02:03.241482+00
Date Added: 2024-06-11T08:28:23.612432
License: Public Domain

In the United States Court of Federal Claims
                                  OFFICE OF SPECIAL MASTERS
                                          No. 19-1384V
                                         UNPUBLISHED

    DAVID SMITH,                                               Chief Special Master Corcoran

                         Petitioner,
    v.                                                         Filed: December 2, 2021

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

Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for
Petitioner.

Mark Kim Hellie, U.S. Department of Justice, Washington, DC, for Respondent.

                                     RULING ON ENTITLEMENT1

      On September 11, 2019, David Smith 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 as a result of the influenza (“flu”) vaccine on October
16, 2018, he suffered a shoulder injury related to vaccination (“SIRVA”) as defined on the
Vaccine Injury Table (the “Table”). Petition (ECF No. 1) at Preamble. 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  Because this unpublished opinion contains a reasoned explanation for the action in this case, I am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.

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 a preponderance of evidence supports
the conclusion that Petitioner suffered the onset of shoulder pain within 48 hours after
vaccination, and that Petitioner is entitled to compensation for a right SIRVA.

     I.   Relevant Procedural History

       As noted above, the case was filed, activated, and assigned to the SPU in
September 2019. On June 12, 2020, Respondent provided an informal review of the case,
noting only that Petitioner did not seek treatment for the injury alleged until 43 days after
vaccination despite seeking other intervening medical treatment. ECF No. 14.

       On July 27, 2020, Petitioner conveyed a settlement demand to Respondent. ECF
No. 16. On February 12, 2021, Respondent completed his formal medical review of the
case and entered into settlement discussions. ECF No. 21. However, on June 28, 2021,
the parties advised that they had reached an impasse. ECF Nos. 23-25.

       On August 24, 2021, Respondent filed his report pursuant to Vaccine Rule 4(c), in
which he opposed compensation for a Table SIRVA on the basis that Petitioner had not
provided preponderant evidence of onset within 48 hours after vaccination. Respondent
noted Petitioner’s 36-day post-vaccination urgent care encounter for fever and
gastrointestinal issues (at which time there was no mention of shoulder pain), along with
the fact that he waited, in total, 43 days post-vaccination to seek medical treatment for
his shoulder. Respondent also averred that “Petitioner’s reported claims of onset to his
medical providers several weeks after vaccination is insufficient evidence to support his
claim[ed]” onset. Rule 4(c) Report (ECF No. 27) at 7.

       I then directed both parties to file briefs and any other evidence that would facilitate
my resolution of the disputed issues. ECF No. 28. Petitioner filed updated medical records
and supplemental affidavits (Exs. 11-16), followed by his brief (ECF No. 30).3 Respondent
did not make any further filings. This matter is now ripe for adjudication.

    II.   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 special master must consider, but is not bound by, any diagnosis,
conclusion, judgment, test result, report, or summary concerning the nature, causation,

3
  Petitioner filed his brief slightly out of time. The deadline fell on a Friday and he filed the brief on the
following Monday. It is nonetheless accepted sua sponte.

                                                      2
and aggravation of petitioner’s injury or illness that is contained in a medical record.
Section 13(b)(1). “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).

       Accordingly, where medical records are clear, consistent, and complete, they
should be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-
1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule
does not always apply. In Lowrie, the special master wrote that “written records which
are, themselves, inconsistent, should be accorded less deference than those which are
internally consistent.” Lowrie, at *19. And the Federal Circuit recently “reject[ed] as
incorrect the presumption that medical records are accurate and complete as to all the
patient’s physical conditions.” Kirby v. Sec’y of Health & Human Servs., 997 F.3d 1378,
1383 (Fed. Cir. 2021).

        The United States Court of Federal Claims has recognized that “medical records
may be incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed.
Cl. 381, 391 (1998). The Court later outlined four possible explanations for
inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that
happened during the relevant time period; (2) the medical professional’s failure to
document everything reported to her or him; (3) a person’s faulty recollection of the events
when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did
not exist. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013),
aff’d, 746 F.3d 1335 (Fed. Cir. 2014).

       The Court has also said that medical records may be outweighed by testimony that
is given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42 Fed.
Cl. at 391 (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL
408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering
such testimony must also be determined. Andreu v. Sec’y of Health & Human Servs., 569
F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d
1570, 1575 (Fed. Cir. 1993).

                                              3
        A special master may find that the first symptom or manifestation of onset of an
injury occurred “within the time period described in the Vaccine Injury Table even though
the occurrence of such symptom or manifestation was not recorded or was incorrectly
recorded as having occurred outside such period.” Section 13(b)(2). “Such a finding may
be made only upon demonstration by a preponderance of the evidence that the onset [of
the injury] ... did in fact occur within the time period described in the Vaccine Injury Table.”
Id.

       The special master is obligated to fully consider and compare the medical records,
testimony, and all other “relevant and reliable evidence contained in the record.” La
Londe, 110 Fed. Cl. at 204 (citing § 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of
Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the
special master's discretion to determine whether to afford greater weight to medical
records or to other evidence, such as oral testimony surrounding the events in question
that was given at a later date, provided that such determination is rational).

    III.   Relevant Factual Evidence

     I have fully reviewed the evidence, including all medical records and affidavits,
Respondent’s Rule 4(c) Report, and Petitioner’s brief. I find most relevant the following:

             •   Upon receiving the subject vaccination, Mr. Smith was sixty-five (65) years
                 old and was generally healthy, with no history of complaints related to his
                 left upper extremity. He was retired and resided with his wife.

             •   Petitioner was an established patient of Brian Edward Wysong, M.D. at the
                 South Point Family Practice in Belmont, North Carolina. In the three years
                 before vaccination, Petitioner sought medical care infrequently, most often
                 for comprehensive annual exams and maintenance of his longstanding
                 hypothyroidism.4 Ex. 2 at 3-4; 91-234.

             •   On October 16, 2018, Petitioner presented to Dr. Wysong’s practice to
                 receive a seasonal flu vaccine. A medical assistant administered the flu
                 vaccine into Petitioner’s left deltoid muscle. Ex. 1 at 1; Ex. 2 at 82-83.

             •   Thirty-six (36) days post-vaccination, on November 21, 2018, Petitioner
                 presented to urgent care. He reported waking up at 1:00 a.m. “shaking
                 violently with chills,” and additional symptoms of fever, dysuria, urinary
                 urgency, and decreased appetite. He did not raise any complaints

4
 Respondent stated that Petitioner’s hypothyroidism was a “significant” aspect of his medical history. Rule
4(c) Report at 2 (citing Ex. 2 at 81). However, Respondent did not contend that condition is an obstacle to
entitlement for the injury alleged, nor do I see preponderant evidence for such.

                                                    4
                 concerning his left shoulder. A physician assistant (“PA”) conducted a
                 limited physical exam which did not address the musculoskeletal system.
                 The only neurological finding was that Petitioner was “alert.” The PA
                 assessed Petitioner with unspecified fever and pyelonephritis5 for which she
                 gave an intramuscular antibiotic injection.6 She prescribed an oral antibiotic
                 as well as an anti-nausea medication to have on hand over the upcoming
                 holiday.7 Ex. 2 at 66-69.

            •    Forty-three (43) days post-vaccination, on November 28, 2018, Dr. Wysong
                 saw Petitioner for a chief complaint of left shoulder pain “for the past month.”
                 Dr. Wysong also recorded: “This started after getting a flu shot. He said that
                 the flu shot hurt. It has hurt every [sic] then.” Petitioner reported pain upon
                 moving his shoulder, such as reaching for a keyboard or putting on or taking
                 off a jacket. Motrin had not helped. On exam, Dr. Wysong observed that
                 Petitioner had no weakness and full range of motion, but pain upon
                 abduction. Dr. Wysong assessed left shoulder bursitis and injected a
                 subacromial steroid injection. He told Petitioner to follow up if his symptoms
                 worsened or failed to improve. Ex. 2 at 43-45.8

            •    Upon following up with Dr. Wysong on December 31, 2018, Petitioner
                 reiterated that his left shoulder pain “all started with the flu shot.” Since the
                 steroid injection, he was “definitely better,” but he was “still having sharp
                 pains with reaching out or doing certain things.” Dr. Wysong documented
                 no tenderness and normal range of motion, but pain on internal and external
                 rotation. He referred Petitioner to physical therapy (“PT”). Ex. 2 at 30-32.

            •    At the initial consult with physical therapist Joseph Nowak on January 2,
                 2019, Petitioner reported that: “Back in mid-October, I got my flu shot. The
                 next day my left shoulder was hurting pretty bad (anterior/ lateral left
                 shoulder) …” PT Nowak documented left shoulder flexion to 168 degrees
                 and abduction to 165 degrees – and normal internal and external rotation,
                 although all of those movements elicited pain. Petitioner had mild pain on

5
  Pyelonephritis is defined as inflammation of the kidney and renal pelvis due to bacterial infection. Dorland’s
Illustrated Medical Dictionary, available at https://www.dorlandsonline.com (hereinafter “Dorland’s”).
6
  Respondent notes that the antibiotic injection was intramuscular, but the site of administration is not noted.
Rule 4(c) Report at n.1. I find insufficient evidence in the record to determine that this antibiotic was
administered in the left shoulder or that it represents a potential alternative cause for Petitioner’s shoulder
injury, which he consistently attributed to the vaccine over one month earlier.

7
     The    following  day,   Thursday,    November    22,  2018, was   Thanksgiving. See
https://www.timeanddate.com/calendar/monthly.html%3Fyear%3D2018%26month%3D11%26country%3
D1.
8
  Petitioner also reported that he “had a UTI last week, but better from that.” Regardless, Dr. Wysong
prescribed another 10-day course of oral antibiotics. Ex. 2 at 43, 45.

                                                       5
    palpation. He was between 1% and 20% impaired in carrying, moving, and
    handling objects. He was given home exercises and a plan for further
    therapy to “decrease inflammation.” Ex. 7 at 1-3.

•   After attending three PT sessions and not progressing, on January 16,
    2019, Petitioner self-discharged. He planned to follow up with Dr. Wysong
    and seek a referral to an orthopedist. Ex. 7 at 4-7.

•   On January 31, 2019, Dr. Wysong recorded that Petitioner had continued
    left shoulder pain, which he had aggravated a week earlier while using a
    crank drill underneath his house. Dr. Wysong referred to an orthopedic
    surgeon, Erik Johnson, M.D., for further evaluation and treatment. Ex. 2 at
    17-19.

•   At the February 12, 2019, initial consult with Dr. Johnson, Petitioner
    reported that he “developed acute onset of left shoulder pain on October
    16, 2018 after a flu shot into the left deltoid region.” The one steroid injection
    had “help[ed] him out” but did not lead to long-term improvement. Petitioner
    was also concerned that too many steroid injections would exacerbate his
    preexisting eye condition. He reported current pain of about 8/10. He was
    taking over-the-counter Advil, Motrin, and Tylenol. On physical exam, Dr.
    Johnson observed normal passive range of motion, but limited active range
    of motion secondary to weakness and pain. He had positive impingement
    signs. An x-ray of the shoulder was unremarkable. Dr. Johnson’s initial
    impression was a left shoulder rotator cuff tear. Ex. 3 at 6-7.

•   On February 18, 2019, an MRI of the left shoulder was conducted, which
    was “limited by some patient motion.” Within the rotator cuff, the
    supraspinatus tendon contained an area of “partial” tearing as well as
    potential, “very minimal” fraying. The labrum was concerning for “a small
    area of tearing,” and additional “minimal fraying” could not be excluded.
    There were no findings in the bursa, although there was possible minimal
    thickening and increased signal within the inferior joint capsule. The MRI
    could not exclude findings of early adhesive capsulitis, which would need
    clinical correlation. Ex. 3 at 8-9; see also Ex. 3 at 5 (February 21, 2019
    follow-up appointment with Dr. Johnson).

•   On April 25, 2019, Petitioner reported that his pain was worse as opposed
    to better and interfering with his sleep. Dr. Johnson instructed Petitioner to
    keep moving the shoulder to keep it from getting stiff. Dr. Johnson also
    discussed potential interventions. Petitioner decided to undergo surgery
    after pre-planned trips to visit his daughter and to accompany his wife to an
    oncology follow-up appointment. Ex. 3 at 5.

                                    6
            •   On June 19, 2019, Dr. Johnson performed a left shoulder arthroscopy with
                extensive intraarticular debridement, capsular release, and subacromial
                decompression. The post-operative diagnosis was left shoulder adhesive
                capsulitis with subacromial impingement. Ex. 5 at 7-8.

            •   Petitioner attended a total of twenty-five (25) post-operative PT sessions
                between July 3rd and October 21st, 2019. See generally Exs. 7, 9. Upon
                discharge, he reported: “Doing much better overall compared to where we
                were. Sleeping is still the biggest problem. I get maybe 2 hours of sleep in
                my bed then have to switch to the recliner.” He was able to don and doff
                clothing and drive a car for one hour without increased shoulder pain. He
                had achieved over 160 degrees on active scaption9 but fell short of that goal
                (152 degrees) on active flexion. Ex. 9 at 24.

            •   Petitioner also followed up periodically with Dr. Johnson, including on
                September 17, 2019, when he brought “information regarding a shoulder
                injury related to vaccine administration.” Ex. 10 at 1. Dr. Johnson recorded
                that this material was “a very interesting read” on a subject which he was
                previously “not very familiar.” Id.

            •   On October 22, 2019, Dr. Johnson observed that Petitioner had normal
                range of motion and no impingement signs. He had “made steady
                improvement” but would likely “always have a little bit of stiffness and
                weakness in the shoulder,” which Dr. Johnson assessed as a 10%
                impairment. Petitioner would continue a home exercise program. He had
                “retained an attorney in Washington, D.C.” Ex. 10 at 2.

            •   At the next encounter with Dr. Johnson on July 27, 2020, Petitioner reported
                pain and stiffness associated with a driving trip, as well as some home
                improvement projects. The exam was similar with the addition of “very
                minimal” impingement signs and strength of 4/5. Ex. 11 at 1.

            •   At the last appointment with Dr. Johnson in the record, on April 27, 2021,
                Petitioner reported some ongoing stiffness. He had “very little pain at rest
                but some pain with activities.” He could not externally rotate his left arm to
                put it under the pillow while sleeping on his left side. Dr. Johnson again
                advised that Petitioner was “the best he will be.” Ex. 11 at 2.

            •   In his affidavit (dated October 14, 2021), Mr. Smith avers that upon
                receiving the October 16, 2018, flu vaccine, he “immediately felt pain and
                noticed that the injection site was rather high and off-center toward my
                back.” Ex. 12 at ¶ 1. He experienced continuing discomfort which

9
 Scaption (also known as scapular plane elevation) describes raising an arm from the side of the body and
slightly forward. Healthline, Scaption, https://www.healthline.com/health/scaption#definition (last accessed
November 17, 2021).

                                                     7
              progressed that evening, the following day, and over the subsequent weeks.
              Id. at ¶ 2. He tried to avoid using his arm and hoped the pain would go away,
              but it persisted. Id. at ¶ 3.

          •   Petitioner had volunteered with Operation Christmas Child for many years.
              Ex. 12 at ¶ 4. But during the gift collection week from November 12th
              through November 19th, 2018, he was unable to load the cartons of gifts
              and he was limited to administrative tasks because his arm hurt so badly.
              Id. at ¶ 5.

          •   Petitioner does not address the November 21, 2018, urgent care encounter
              or his delay in seeking medical treatment for his shoulder. See generally
              Ex. 12.

          •   His wife recalls receiving their flu vaccines together on October 16, 2018.
              Ex. 13 at ¶ 1. While she did not feel any discomfort upon vaccination, she
              witnessed Petitioner displaying a “pained look,” telling the nurse that it hurt,
              and commenting afterward that the injection seemed too high on his arm.
              Id. She also recalls that the next morning, Petitioner got up from bed and
              reported left shoulder and arm pain throughout that night. Id. at ¶ 2.
              Petitioner continued to experience pain and hoped it would get better, but it
              never did. Id.

          •   Petitioner’s son, who lives several hundred miles away, recalled that his
              mother mentioned Petitioner’s shoulder pain during a phone conversation
              “the day after the shot.” Ex. 14 at ¶ 1.

          •   A friend who also volunteered with Operation Christmas Child recalled that
              normally Petitioner was very active and helpful in the loading of the boxes
              into the trucks. Ex. 15 at ¶ 1. However, during in November 2018, he could
              only complete paperwork because his shoulder hurt too much.

          •   Another friend recalled that “in the fall of 2018,” Petitioner and his wife
              recounted his left shoulder pain beginning immediately after a flu vaccine.
              Ex. 16.

IV.    Findings of Fact Regarding Onset

       In opposing compensation for a Table SIRVA, Respondent only contended that
Petitioner has not established the requisite onset of shoulder pain within 48 hours after
vaccination. Rule 4(c) Report at 7 (citing 42 C.F.R. §§ 100.3(a)(XII)(A), (c)(10)(ii)).

       Respondent noted that Petitioner waited forty-three (43) days to pursue medical
treatment for his shoulder. Rule 4(c) Report at 7. Mr. Smith’s medical records, affidavits,
and legal brief fail to address this delay. However, I have previously recognized that there

                                              8
are a variety of reasonable explanations for why a SIRVA petitioner might delay
treatment, such as “thinking his/her injury will resolve on its own.” Winkle v. Sec’y of
Health & Human Servs., No. 20-0485, 2021 WL 2808993, at *4 (Fed. Cl. Spec. Mstr. June
3, 2021) (finding that a petitioner developed shoulder pain within 48 hours after
vaccination, despite the fact that she waited nearly five months to seek medical attention).
Such a delay in treatment, while relevant to damages (since it tends to establish a milder
injury), is not unprecedented for SIRVA claims.

       More notable is the intervening medical encounter for unrelated issues 37 days
after vaccination, at which point the shoulder pain could reasonably be characterized as
persistent and perhaps warranting medical attention – but was not mentioned. Petitioner
has not offered any explanation for why this medical record does not address his alleged
shoulder pain. However, Respondent admits that the record specifically concerned
“emergency care for a fever and gastrointestinal issues.” Rule 4(c) Report at 7. Moreover,
the Federal Circuit has recognized that a medical record can be “silent” as to either the
existence or nonexistence of a particular symptom – and that this silence does not defeat
a contrary finding supported by reasonable sworn testimony. Kirby, 997 F.3d at 1383.
Here, the urgent care record is clearly focused on Petitioner’s acute infection and does
not address his musculoskeletal system. It thus does not prove or disprove the existence
of shoulder pain, which Petitioner indeed reported to his primary care provider just one
week later after the Thanksgiving holiday.

        Respondent also argued that Petitioner’s “reported claims of onset to his medical
providers several weeks after vaccination are insufficient evidence to support his claim
that his shoulder pain began within 48 hours of vaccination.” Rule 4(c) Report at 7. But
as previously noted, this argument ignores the fact that even a medical history provided
to a petitioner’s provider, and in the context of seeking medical treatment, has some
indicia of reliability. Hartman v. Sec’y of Health & Human Servs., No. 19-1106V, 2021 WL
4823549, at *5 (Fed. Cl. Spec. Mstr. Sept. 14, 2021) (crediting the claimant’s history of
the onset of her shoulder pain, within subsequent medical records focused on diagnosis
and treatment of said shoulder pain), citing Cucuras, 993 F.2d at 1528.

       Furthermore, since Respondent filed his Rule 4(c) Report, several other individuals
have offered their own independent recollections of onset. This includes Petitioner’s wife,
who remembers his immediate and persisting pain, and the fellow volunteer, who
observed Petitioner’s limitations due to shoulder pain in mid-November 2018 (prior to both
the urgent care visit and the first medical attention for shoulder pain).

                                             9
      In sum, the record contains preponderant evidence that Mr. Smith developed left
shoulder pain within 48 hours after vaccination.10

 V.     Other Table Requirements and Entitlement

        In light of the lack of other objections and my own review of the record, I find that
Petitioner has established the other requirements for a Table SIRVA claim. Specifically,
there is not a history of prior shoulder pathology that would explain his injury. 42 C.F.R.
§ 100.3(c)(3)(10)(i). There is no evidence of any other condition or abnormality that
represents an alternative cause. 42 C.F.R. § 100.3(c)(3)(10)(iii). The medical records and
affidavits support that his shoulder pain and reduced range of motion were limited to the
left shoulder. C.F.R. § 100.3(c)(3)(10)(iv). The contemporaneous vaccination record
reflects the site of administration as his left deltoid. Ex. 1; Sections 11(c)(1)(A) and (B)(i).
Petitioner has not pursued a civil action or other compensation. Ex. 8 at ¶ 1; Section
11(c)(1)(E). Finally, Petitioner suffered the residual effects for more than six months after
vaccination and moreover, underwent hospitalization and surgical intervention for the
injury alleged. Thus, Petitioner has satisfied all requirements for entitlement under the
Vaccine Act.

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.

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

10
  However, Petitioner’s delay in seeking treatment – despite access to healthcare providers – does support
that his pain was less severe, which is relevant to the determination of an appropriate damages award.

                                                   10