Court Opinion

ID: 6322241
Source: CourtListenerOpinion
Date Created: 2022-03-11 14:01:27.248012+00
Date Added: 2024-06-11T09:20:43.182101
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                           No. 20-1430V
                                          UNPUBLISHED

    SANDRA ANZALONE,                                            Chief Special Master Corcoran

                         Petitioner,                            Filed: February 7, 2022
    v.
                                                                Special Processing Unit (SPU);
    SECRETARY OF HEALTH AND                                     Findings of Fact; Site of Vaccination
    HUMAN SERVICES,                                             Influenza (Flu) Vaccine; Shoulder
                                                                Injury Related to Vaccine
                         Respondent.                            Administration (SIRVA)

Joseph J. Manna, Lipsitz, Green, et al., Buffalo, NY, for Petitioner.

Jennifer A. Shah, U.S. Department of Justice, Washington, DC, for Respondent.

                                           FINDINGS OF FACT1

      On October 22, 2020, Sandra Anzalone 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 an influenza (“flu”)
vaccine on October 25, 2017. Petition 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1 Because this unpublished Fact Ruling contains a reasoned explanation for the action in this case, I am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.

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 the flu vaccine was most likely
administered in Petitioner’s left deltoid, as alleged.

   I.     Relevant Procedural History

       Along with the Petition, Ms. Anzalone filed her affidavit and the medical records
usually required under the Vaccine Act. Exhibits 1-11, ECF No. 1; see Section 11 (c). The
case was activated and assigned to SPU on February 26, 2021. ECF No. 8.

        During the initial status conference, held on April 22, 2021, Respondent’s counsel
indicated that Respondent would like to review any medical records related to an earlier
left shoulder injury in 2006. Order, issued Apr. 23, 2021, at 1, ECF No. 11. She asked if
there was a related worker’s compensation claim for either the 2006 or current 2017
injury. In response, Petitioner’s counsel indicated that Petitioner was informed that her
current injury did not qualify for worker’s compensation, that she believed Petitioner had
not needed treatment for her 2006 injury, that she would confirm that fact and ask about
a worker’s compensation claim related to the earlier injury, and that Petitioner would file
any additional medical records obtained. Id. The parties then discussed the lack of
documentation regarding the site of vaccination and the potential need for a fact ruling
from me on the issue. Id. at 2.

       Three months later, Petitioner filed additional outstanding medical records from
2015 to the present related to treatment she received from specialists such as her
cardiologist. Exhibits 12-17, filed July 22, 2021, ECF No. 14. Petitioner did not file any
medical records related to her 2006 injury. However, she filed a statement of completion
indicating that all medical records had been filed. ECF No. 15.

       On September 21, 2021, Respondent filed a status report noting that Petitioner
had not filed medical records related to her 2006 injury, worker’s compensation records
related to her current injury, or further documentation regarding the site of vaccination.
Status Report at 1, ECF No. 17. Respondent further indicated that he assumed those
records did not exist (id. at 2 n.1) and believed that the factual issue regarding site of
vaccination “should be resolved through further record development while the DICP
review is pending” (id. at 2).

       On November 19, 2021, Petitioner filed a detailed affidavit, additional medical
records, and documentation regarding her 2006 back and shoulder injury, the site of her
2017 vaccination, and the denial of her worker’s compensation claim for the 2017 injury.
Exhibits 18-20, ECF No. 19. She also filed a status report providing detailed information
regarding medical records related to her 2006 injury which may still be outstanding and

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her efforts to obtain those records. ECF No. 20. On January 6, 2022, she filed a brief
regarding the site of vaccination. ECF No. 22.

       In response to an inquiry from court personnel, Respondent’s counsel indicated
that Respondent wished to file a responsive brief. However, on January 28, 2022,
Respondent instead filed a status report indicating that “[a]t this time, [he] takes no
position on the site of administration of the subject vaccination in this case . . . [but]
reserves the right to amend his response once the medical review” is complete. ECF No.
23.

        Respondent was informed on several occasions that I wished to address any
factual issues not requiring medical expertise prior to the HHS review. Additionally, all
available documentation related to Petitioner’s October 25, 2017 vaccination has been
filed. The issue is now ripe for adjudication.

   II.    Issue

       At issue is whether Petitioner received the October 25, 2017 flu vaccine in her left
deltoid, as alleged.

   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,
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 & Hum. 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 & Hum. Servs., No. 03-
1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule
does not always apply. “Written records which are, themselves, inconsistent, should be
accorded less deference than those which are internally consistent.” Murphy v. Sec’y of
Health & Hum. Servs., No. 90-882V, 1991 WL 74931, *4 (Fed. Cl. Spec. Mstr. April 25,

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1991), quoted with approval in decision denying review, 23 Cl. Ct. 726, 733 (1991), aff'd
per curiam, 968 F.2d 1226 (Fed.Cir.1992)). 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 & Hum. Servs., 997 F.3d 1378,
1383 (Fed. Cir. 2021).

        The United States Court of Federal Claims has 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 & Hum. 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 v. Sec’y
of Health & Hum. Servs., 42 Fed. Cl. 381, 391 (1998) (citing Blutstein v. Sec’y of Health
& Hum. Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998).
The credibility of the individual offering such fact testimony must also be determined.
Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley
v. Sec’y of Health & Hum. 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
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 & Hum. 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).

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    IV.    Finding of Fact

      I make the finding regarding site of vaccination after a complete review of the
record to include all medical records, affidavits, documentation, briefing, and additional
evidence filed. Specifically, I base the finding on the following evidence:

           •   The vaccine record filed by Petitioner, consisting of the one-page insurance
               consent form, shows she was administered a full dose of the flu vaccine on
               October 25, 2017. Exhibit 2 at 1. The section indicating site of injection is
               blank – no option is checked. Id.

           •   The vaccine record contains the signature of the nurse administering the
               vaccine. Exhibit 2 at 1. In her affidavit, Petitioner indicated she received the
               vaccine at her place of employment - the Ford Motor Company in Buffalo,
               New York. Exhibit 6 at ¶ 2. Employment records indicate these vaccinations
               were provided by a separate agency visiting the plant. Exhibit 19 at 3
               (indicating Petitioner “tried contacting the agency that gave her the injection
               to report the incident”).

           •   Petitioner’s employment records show when she returned to work the next
               day, Petitioner visited the occupational nurse on duty, complaining of left
               arm pain due to the flu shot she received the previous day. Exhibit 19 at 3.
               She reported that the shot did not hurt when administered but that she was
               unable to raise her left arm by 10pm that evening. Id.

           •   The nurse who treated Petitioner observed ecchymosis3 at the injection site,
               but no redness or swelling. Exhibit 19 at 3. Characterizing the site’s location
               as atypical, she indicated it was “at the top of left arm shoulder.” Id. She
               observed limited range of motion (“ROM”) in Petitioner’s left arm/shoulder.
               Id.

           •   At the October 26 visit, as well as a follow-up visit on November 7, the
               occupational health nurse instructed Petitioner to apply heat and follow-up
               with her primary care provider (“PCP”). Exhibit 19 at 4. She assessed
               Petitioner as “Fit for Work” on November 7, 2017. Id. at 4.

3Ecchymosis is “a small hemorrhagic spot, larger than a petechia, in the skin or mucous membrane forming
a nonelevated, rounded or irregular, blue or purplish patch.” DORLAND’S ILLUSTRATED MEDICAL DICTIONARY
at 588 (32th ed. 2012).

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•    On November 7, 2017, Petitioner also visited her PCP for left arm pain,
    characterized as a reaction to the flu vaccine. Exhibit 3 at 23-24. At this visit,
    she provided the same medical history - left shoulder pain and limited ROM
    which started in the evening after she received a flu vaccine administered
    too high in her left deltoid. Id. at 23. Petitioner’s PCP observed pin with
    palpitation and prescribed x-rays and an MRI. Id. at 23-24.

•   In the record from x-rays, performed on November 9, 2017, it was noted
    that Petitioner had a history of pain in her “left deltoid area over the shoulder
    after getting [a] flu shot 2 weeks ago.” Exhibit 3 at 25.

•   In the report from the MRI, performed on November 27, 2017, it was
    reported that Petitioner had a shot on October 25, 2017, and now has pain
    and decreased ROM in the left shoulder. Exhibit 3 at 26. The MRI revealed
    “[r]ather severe subacromial/subdeltoid bursitis, . . . some internal debris, .
    . . [t]iny partial undersurface tear distally in the supraspinatus tendon, [a]
    [s]mall interstitial tear also seen in the infraspinatus tendon, [and] [n]o full-
    thickness tear noted.” Id.

•   On November 29, 2017, Petitioner returned to her PCP for a follow-up of
    her “left shoulder pain after influenza vaccine from work.” Exhibit 3 at 29.
    Again, observing pain upon palpitation and limited ROM, the PCP discussed
    the MRI results, diagnosed Petitioner with subacromial bursitis of the left
    shoulder joint, and referred her to an orthopedist. Id. at 29-30.

•   When seen by the orthopedist on December 1, 2017, Petitioner again
    reported left shoulder pain which began on October 25, 2017, after she
    received a flu shot at work. Exhibit 8 at 11. She rated her pain, “located
    around her deltoid muscle,” as seven out of ten. The orthopedist observed
    “[m]ild tenderness over the left superior and lateral aspect of the shoulder
    without significant swelling, erythema, or warmth” and limited ROM. Id. He
    administered a cortisone injection. Id. at 12.

•   Also, on December 1, 2017, Petitioner submitted a worker’s compensation
    claim. Exhibit 20 at 11-12. On the claim form, she described her injury as
    continued pain after getting a flu shot which occurred on October 25, 2017,
    and was witnessed by the nurse from Health Maxim who administered the
    vaccination. Id.

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          •   A left shoulder ultrasound, performed on December 3, 2017, revealed an
              “increased subacromial bursitis fluid suggestive of bursitis with [the]
              suggestion of internal debris without increased blood flow.” Exhibit 8 at 16.
              It appears an ultrasound guided cortisone injection was administered at this
              appointment. Id. at 16-17 (handout regarding cortisone injections and
              reference to earlier injection at the next orthopedic appointment on
              December 8, 2017).

          •   Petitioner repeated the same medical history when seen by her orthopedist
              on December 8 and 15, 2017, June 19, August 24, and October 5, 2018.
              Exhibit 8 at 17, 23, 34, 40, 46. On December 8, 2017, it was noted that
              Petitioner was currently not working. She received another ultrasound
              cortisone injection at that visit. Id. at 21. At the next orthopedic appointment
              on December 15, Petitioner was cleared to return to work without restriction
              on December 22, 2017.

          •   On April 1, 2019, Petitioner sought a second opinion from another
              orthopedist. Exhibit 9 at 6-8. She again attributed her left shoulder pain to
              the flu vaccine she received in October 2017, indicating that her pain and
              limited ROM began the next day. Id. at 7.

          •   Petitioner began physical therapy (“PT”) on June 19, 2019. Exhibit 11 at 2-
              4. Throughout her PT records, there are multiple entries linking Petitioner’s
              left shoulder pain with the flu vaccine she received. Id. at 2, 11, 19, 34, 49,
              52, 64, 67, 79, 86, 88, 92, 95, 107, 110.

        The above medical entries show that, when seeking treatment for her left shoulder
pain, Petitioner consistently attributed her pain to the vaccine she reported receiving in
her left arm. She provided these histories to the occupational nurse at work, her PCP, two
orthopedists, and her physical therapist within a day of vaccination and throughout the
subsequent two years thereafter. While originating from Petitioner, these statements are
set forth in contemporaneous records, and should therefore be afforded greater weight
than any subsequent assertion or witness statement. The Federal Circuit has stated that
“[m]edical records, in general, warrant consideration as trustworthy evidence . . . [as they]
contain information supplied to or by health professionals to facilitate diagnosis and
treatment of medical conditions.” Cucuras, 993 F.2d at 1528 (emphasis added). Thus, the
Circuit has instructed that greater weight should be accorded to this class of information,
even when the record in question simply memorializes what the petitioner said at the time.

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        Additionally, in both medical records and her affidavit, Petitioner described the flu
vaccine as improperly administered – given too high in her left deltoid. Exhibit 3 at 23;
Exhibit 6 at ¶ 2. The occupational health nurse who treated Petitioner the day after
vaccination agreed. Exhibit 19 at 3. She observed bruising at the site of vaccination –
identified as the top of Petitioner’s left arm/shoulder. Id. This entry showing the nurse
observed physical evidence supporting Petitioner’s contention that the vaccine was
administered in her left deltoid is extremely probative.

       Although the vaccine record does not indicate the exact site of vaccination, it
clearly establishes that, on October 25, 2017, Petitioner received a flu vaccine.
Furthermore, the medical histories provided by Petitioner in the contemporaneously
created medical records and supporting evidence of the occupational health nurse’s
observations provide persuasive evidence showing the vaccine was administered in
Petitioner’s left deltoid. And there is a dearth of evidence that the vaccine was
administered in any other location. I thus determine, based on the entire record, that
Petitioner has provided preponderant evidence establishing that the flu vaccine to which
Petitioner attributes her SIRVA was most likely administered in her left deltoid on October
25, 2017.

   V.     Scheduling Order

       Based on recent data, I expect the HHS review to be completed in this case in
March 2022. Although not clear whether Petitioner’s injury meets all criteria for a Table
SIRVA, given my finding of fact regarding the site of vaccination, it is appropriate for
Petitioner to forward a demand and supporting documentation to Respondent prior to the
HHS review. And I previously instructed Petitioner to begin finalizing a demand and to
gather any supporting documentation needed. Order at 2, Apr. 23, 2021, ECF No. 11.
Petitioner should continue to finalize her demand which she may forward to Respondent,
along with her supporting documentation, at any time.

      Respondent shall file a status report indicating how he intends to proceed
by no later than Wednesday, March 23, 2022.

         Petitioner shall file a status report updating me on her demand by no later
than Wednesday, March 23, 2022. The status report shall indicate the date by which
Petitioner provided, or intends to provide, a demand and supporting documentation to
Respondent. Additionally, Petitioner shall confirm whether any Medicaid lien exists, and
if so, indicate the date by which Petitioner anticipates providing Respondent a letter from
the appropriate state agency verifying the amount of the lien.

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IT IS SO ORDERED.

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

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