Court Opinion

ID: 4910535
Source: CourtListenerOpinion
Date Created: 2021-09-13 20:06:38.220347+00
Date Added: 2024-06-11T08:13:26.070713
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                           No. 19-1535V
                                          UNPUBLISHED

    JANET NIEMI,                                                Chief Special Master Corcoran

                         Petitioner,                            Filed: August 10, 2021
    v.
                                                                Special Processing Unit (SPU);
    SECRETARY OF HEALTH AND                                     Findings of Fact; Onset; Influenza
    HUMAN SERVICES,                                             (Flu) Vaccine; Shoulder Injury
                                                                Related to Vaccine Administration
                         Respondent.                            (SIRVA)

David John Carney, Green & Schafle LLC, Philadelphia, PA, for Petitioner.

Mollie Danielle Gorney, U.S. Department of Justice, Washington, DC, for Respondent.

                                           FINDINGS OF FACT 1

      On October 2, 2019, Janet Niemi 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) after receiving an influenza (“flu”) vaccination on January 16,
2019. ECF 32 at 1-2. The case was assigned to the Special Processing Unit of the Office
of Special Masters.

1
  Because this unpublished Fact Ruling contains a reasoned explanation for the action in this case, I am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 Fact Ruling 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 the onset of Petitioner’s SIRVA more
likely than not occurred within 48 hours of vaccination.

    I.      Relevant Procedural History

       After an initial status conference in February 2020, Petitioner was ordered to file
 outstanding medical records. ECF 12. Over the next several months, Petitioner
 submitted additional records, and she filed an amended statement of completion in June
 2020. ECF 17. On January 29, 2021, Respondent filed a status report indicating that he
 was interested in pursuing settlement discussions. ECF 24. One month later, Petitioner
 reported that the parties had reached an impasse in their negotiations. ECF 27.
 Respondent was subsequently ordered to file a Rule 4(c) report.

        In his report, Respondent asserts that there is not a preponderance of evidence
demonstrating the requisite facts necessary to establish a Table SIRVA injury. ECF 28.
Specifically, Respondent argues that “the medical records do not establish that
[P]etitioner suffered the first symptoms or manifestation of onset of a shoulder injury within
48 hours of the January 16, 2019 flu vaccination.” Id. at 7. Petitioner then requested that
she be allowed the opportunity to file a motion for a ruling on the record. ECF 29. On May
25, 2021, Petitioner filed her Motion for Ruling on the Record and Brief in Support of
Damages. 3 ECF 31. Respondent filed his responsive brief one month later. ECF 34.
Therefore, this matter is ripe for adjudication.

    II.     Issue

      At issue is whether Petitioner’s first symptom or manifestation of onset after
vaccine administration (specifically pain) occurred within 48 hours as set forth in the
Vaccine Injury Table and Qualifications and Aids to Interpretation (“QAI”) for a Table
SIRVA. 42 C.F.R. § 100.3(c)(10)(ii).

    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 special master must consider, but is not bound by, any diagnosis,

3
  While Petitioner briefed damages in her Motion for Ruling on the Record, she had been advised in the
Scheduling Order dated May 11, 2021, to limit her argument to the issue of entitlement. ECF 29. Pursuant
to this order, Respondent addressed only the issue of entitlement in his brief. ECF 34. Accordingly, I find
Petitioner’s briefing of damages premature (although if any further briefing of damages is called for,
Petitioner will be given the opportunity to update or supplement any facts or argument made on this subject
to date).

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conclusion, judgment, test result, report, or summary concerning the nature, causation,
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.

        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).

        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

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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 Section 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).

   IV.    Finding of Fact

      I make these findings after a complete review of the record, including all medical
records, affidavits, testimony, expert reports, respondent’s Rule 4 report, and additional
evidence filed. Specifically, I base the findings on the following evidence:

          •   On January 16, 2019, Petitioner received an intramuscular flu vaccine in
              her left deltoid. Ex 1 at 2-3.

          •   On February 14, 2019, Petitioner visited the emergency room (ER) for a
              head injury after falling off a chair at work. Ex 10 at 59. While at the ER,
              Petitioner did not report pain in any extremities and physical examination
              (PE) revealed full range of motion. Id. at 61.

          •   On February 19, 2019, Petitioner followed up telephonically with a nurse at
              her primary care provider’s (PCP) office for her head injury. Ex 3 at 49.
              During the call, she denied difficulty moving her arms. Id.

          •   On March 5, 2019, Petitioner visited her PCP to discuss her fall in February
              2019. Ex 3 at 51. She now also reported left arm pain and decreased
              range of motion “after” receiving her flu shot. Id. She showed
              decreased range of motion in the left shoulder, and the PCP questioned if
              an intra-articular injection of the flu vaccine caused Petitioner’s injury. Id. at
              53. Petitioner was referred to an orthopedist. Id.

          •   On March 20, 2019, Petitioner presented to Dr. Daniel Bauk, an orthopedist,
              with a complaint of “got her flu shot on January 17 [sic], 2019, and the next
              day began having pain in her shoulder.” Ex 5 at 8. Dr. Bauk’s exam
              revealed diffuse tenderness to palpation and pain with range of motion, and
              he diagnosed Petitioner with adhesive capsulitis. Id. at 9.

          •   On April 11, 2019, Petitioner underwent an initial evaluation for physical
              therapy, at which time she reported left shoulder pain with onset of

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                 January 17, 2019 after receiving a flu vaccine that was injected “too high”
                 on her shoulder. Ex 9 at 11.

            •    On September 13, 2019, Petitioner had a consultation with Dr. Peter
                 Johnston, another orthopedist. Ex 8 at 4. She complained of “flu shot back
                 in January and since has been struggling with significant left shoulder
                 pain.” Id.

            •    In her affidavit, Petitioner states that “within two days of receiving the
                 injection, [she] began to experience pain in [her] arm at the injection
                 site that spread to [her] shoulder over the ensuing days.” Ex 2 at 2.

        Respondent argues that the seven-week gap between Petitioner’s flu vaccine and
first recorded report of left arm pain fails to support onset within 48 hours. ECF 34 at 6-8.
He specifically focuses on the fact that Petitioner sought medical care twice between the
time she received the subject vaccination and the first time she reported shoulder pain to
a medical provider. Id. at 7. However, it was not unreasonable for Ms. Niemi not to have
reported shoulder pain at her ER visit, as she was likely focused on treating her head
injury, a more concerning medical event. 4 Additionally, while exam of Petitioner’s upper
extremities at the ER was noted to be normal, such ER-provided examinations are often
cursory, especially when the visit is focused on an emergent injury to another part of the
body. Further, while Respondent in his brief characterizes Petitioner’s February 19, 2019
contact with her PCP’s office as an “intervening medical visit,” the record reflects that this
was in fact only a phone call with a nurse to specifically discuss her head injury. Ex 3 at
49.
       In focusing on the admitted gap in treatment, Respondent seems to be arguing
that the only way Petitioner can show she experienced symptoms within 48 hours of
vaccination is with contemporaneous records created within that two-day timeframe. But
the Vaccine Act clearly does not require that symptoms be recorded within a specific
timeframe to be preponderantly established. Rather, it requires only that onset occurs in
the relevant timeframe. 42 U.S.C. § 300aa-13. Of course, the reliability of onset evidence
may hinge on when and how onset is recorded, and evidence of post-vaccination pain
from a record created no more than two days post-vaccination would constitute
particularly strong evidence of onset. But a petitioner can still prevail even if the evidence
establishing onset comes from a later period. Ultimately, resolving how to weigh the
evidence pro and con on such matters falls within the purview of the special masters. Id.
       Given the above, I find that the two records at issue (specifically Petitioner’s report
to her orthopedist on March 20, 2019, and her physical therapist on April 11, 2019) are
consistent with Petitioner’s affidavit testimony that her left shoulder pain began with 48

4
 Indeed, the medical records from her ER visit reflect that a CT scan of the brain showed a left posterolateral
occipital contusion and a subgaleal hematoma. Ex 10 at 61-63.

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hours of vaccination. In addition, I do not find that the gap between vaccination date and
Petitioner’s first report of shoulder pain greatly weakens the conclusion that her claimed
onset “more likely than not” occurred within the timeframe for a Table SIRVA injury. While
some cases might be stronger and some weaker, the evidence in this case is enough to
preponderantly establish that the onset of Petitioner’s left shoulder injury occurred within
48 hours of her January 16, 2019 flu vaccination.

   V.     Scheduling Order

      Given my findings of fact regarding the onset of Ms. Niemi’s pain, Respondent
should evaluate and provide his current position regarding the merits of Petitioner’s case.

      Accordingly, Respondent shall file, by no later than Monday, September 13,
2021, an amended Rule 4 report reflecting Respondent’s position in light of the
above fact finding.

IT IS SO ORDERED.

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

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