Court Opinion

ID: 6353257
Source: CourtListenerOpinion
Date Created: 2022-06-23 21:01:14.880191+00
Date Added: 2024-06-11T09:13:58.538162
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                           No. 21-0881V
                                          UNPUBLISHED

    ZEHRA RIZVI,                                                Chief Special Master Corcoran

                         Petitioner,                            Filed: May 13, 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)

Alison H. Haskins, Maglio Christopher & Toale, PA, Sarasota, FL, for Petitioner.

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

                                           FINDINGS OF FACT1

         On February 8, 2021, Zehra Rizvi 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 shoulder injury related to vaccine
administration (“SIRVA”), as defined in the Vaccine Table, after receiving the influenza
(“flu”) vaccine in her left deltoid on October 9, 2019. Petition at 1, ¶¶ 3, 15-16, 18.

1 Because this unpublished Fact Ruling contains a reasoned explanation for the action in this case, I am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).
       The vaccine record does not indicate the site or method of administration. Exhibit
1 at 4. And the later provided vaccine consent form indicates the vaccine was
administered intramuscularly in Petitioner’s right arm, rather than left arm as alleged.
Exhibit 23 at 7. Nevertheless, and for the reasons discussed below, I find the flu vaccine
was likely administered in Petitioner’s left arm, as alleged.

              I.      Relevant Procedural History

       During the three months after her petition was filed, Ms. Rizvi filed the medical
records required under the Vaccine Act. Exhibits 1-21, ECF Nos. 6-7, 9-10; see Section
11(c). On May 27, 2021, the case was activated and assigned to the Special Processing
Unit (OSM’s process for attempting to resolve certain, likely-to-settle claims (the “SPU”)).
ECF No. 11.

        Because the vaccine record, provided on February 22, 2021, did not indicate the
site or method of vaccination, Petitioner was ordered to file additional documentation or
evidence to establish that she received the flu vaccine intramuscularly in her left deltoid
as alleged. Order, issued Aug. 16, 2021, ECF No. 14. After multiple requests for additional
time, Petitioner filed updated orthopedic records and additional documentation - but which
indicates the flu vaccine was administered in Petitioner’s right rather than left arm.
Exhibits 22-23, filed Feb. 28, 2022, ECF No. 21. On March 30, 2022, she filed
supplemental declarations3 from herself and her son, along with a motion requesting a
factual finding regarding the site of vaccination. Exhibits 24-25, ECF No. 24; Motion for
Finding of Fact Regarding Injection Site (“Motion”), ECF No. 25.

       A deadline for a responsive filing from Respondent was set, and Respondent was
informed that, due to my desire to address this issue prior to final HHS review, he should
alert me if he decided not to file a response. Non-pdf Order, issued March 31, 2022. On
April 28, 2022, Respondent informed me that he did not wish to file a response. The
matter is now ripe for adjudication.

              II.     Issue

       At issue is whether Petitioner received the vaccination alleged as causal in her
injured left shoulder, rather than her right shoulder as the vaccine record indicates.

3   These declarations were signed under penalty of perjury as required by 28 U.S.C.A. § 1746.

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          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,
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.

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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).

          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, and additional evidence filed. Specifically,
I note the following evidence:

          •     Petitioner’s prior medical records reveal no prior complaints of shoulder
                pain. See generally, Exhibits 8, 11, 14.

          •     Petitioner received the flu vaccine alleged as causal on October 3, 2019.
                Exhibits 1, 23. On the second page of the consent form, under the
                pharmacist’s signature, the choices of “IM” and “RA” are circled – seeming
                to indicate that the vaccine was administered intramuscularly in Petitioner’s
                right arm. Exhibit 23 at 7. No other immediately-contemporaneous record
                sets forth the administration situs.

          •     In her latest provided declaration, Petitioner indicated that prior to
                administering flu vaccines to herself and her son, the technician asked them
                which arm was dominant. Exhibit 24 at ¶¶ 5-6. According to Petitioner, he
                then administered the flu vaccines in their non-dominant arms – the left arm
                for both. Id. In his declaration, Petitioner’s son echoes these same

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    assertions. Exhibit 25 at ¶¶ 3-4. He also recalled that Petitioner began
    complaining of pain in her left arm that evening Id. at ¶ 5.

•   Approximately two weeks later, on October 16, 2019, Petitioner was treated
    by an orthopedist at the same practice as her husband, who is an
    endocrinologist, complaining of left shoulder pain and weakness since
    receiving the flu vaccine in that shoulder. Exhibit 2 at 6; see Exhibit 24 at ¶
    11 (Petitioner’s declaration explaining her husband’s relationship to the
    orthopedist). The record indicates Petitioner is right-hand dominant. Exhibit
    2 at 6. The orthopedist administered a cortisone injection, provided pain
    medication, and instructed Ms. Rizvi to undergo an MRI after her move to
    Atlanta. Id. at 7.

•   After relocating to Atlanta, Petitioner was seen by an orthopedist on January
    27, 2020. Exhibit 5 at 19-21. Again, she was noted to be right-hand
    dominant, and complained of left shoulder pain since receiving an
    improperly administered flu vaccine in her left shoulder. Reporting little relief
    after the cortisone injection and medication administered and prescribed in
    mid-October 2019, she described her pain as located deep in her shoulder
    and radiating into her distal biceps area. Petitioner was assessed as having
    a left shoulder injury related to vaccine administration with secondary rotator
    cuff impingement,” not requiring surgery. Id. at 20. She was instructed to
    undergo physical therapy, and the orthopedist agreed that Petitioner’s plan
    to try medical acupuncture was “reasonable.” Id. He added that an MRI
    could be ordered if Petitioner was “not making progress.” Id.

•   On January 30, 2020, Petitioner sought treatment from an acupuncturist,
    again complaining of left shoulder pain from a flu vaccine received four
    months earlier. Exhibit 4 at 1. Petitioner described her pain as severe and
    located in her left shoulder and biceps. Id. at 5.

•   At her gynecology appointment on March 9, 2020, Petitioner mentioned a
    history of a shoulder injury from a flu vaccine. Exhibit 8 at 7.

•   On April 10, 2020, Petitioner sought follow-up orthopedic treatment of her
    left shoulder injury during a telehealth appointment. Reporting a worsening
    of symptoms, Petitioner indicated she had pursued acupuncture during the
    month of February, had been unable to attend PT due to the COVID
    pandemic, and had attempted to perform exercises at home. Exhibit 5 at
    16. However, she noticed that she was also experiencing decreased range
    of motion. Id. The orthopedist observed that Petitioner was not making

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              progress and that some of her pain appeared to be neuropathic. Id. at 17.
              Petitioner chose not to take oral steroids – indicating she would continue
              her current pain medication, and agreed to undergo an MRI. Id.

          •   Performed on April 13, 2020, the MRI showed a mild amount of fluid, but no
              injury to the rotator cuff. Exhibit 5 at 13.

          •   On April 15, 2020, Petitioner participated in a telehealth appointment with
              Dr. Marko Bodor in Northern California. Exhibit 3 at 2-3. She again reported
              left shoulder pain following receipt of the flu vaccine in October 2019. Id. at
              2. Dr. Bodor observed that her condition had progressed to a frozen
              shoulder and discussed the possibility of her undergoing ultrasound guided
              anesthetic injection if she was willing to come to California. Id. at 3.
              Petitioner underwent this procedure on April 23, 2020. Id. at 5.

          •   Petitioner began PT on May 8, 2020. Exhibit 16 at 21-24. At her initial
              session, she reported her “[s]ymptoms began after getting the flu shot in
              October of 2019.” Id. at 22. By her fifth and final PT sessions on June 5,
              2020, Petitioner indicated her condition was improving. Id. at 15.

          •   At her next orthopedic appointment on June 18, 2020, Petitioner reported
              improvement in her pain and ROM. Exhibit 5 at 4. However, she also
              complained of an aggravation of Achilles tendinopathy which she had
              suffered from for the last ten years. Id.

        The above medical entries establish that when seeking medical treatment on
multiple occasions during the year following the October 2019 vaccination, Petitioner
consistently reported left shoulder pain, which she attributed to that vaccination. She also
sought treatment close in time to her injury - visiting an orthopedist thirteen-days post-
vaccination. Even when seen by her gynecologist for a well-woman appointment
approximately five months post-vaccination, Petitioner mentioned her shoulder injury and
attributed its cause to the flu vaccine she received.

       Additionally, Petitioner provided a further rational as to why the vaccination was
administered in her left, rather than right arm – the fact that she is right-hand dominant.
This information is repeated in several contemporaneously created medical records
describing treatment of Petitioner’s left shoulder injury. And both Petitioner and her son
indicated they were asked which arm they preferred right before the vaccination was
given – and expressed a desire to avoid their dominant arm (a reasonable request that
vaccinated individuals often make).

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        Based upon my experience resolving SPU SIRVA cases (more than 1,200 cases
since my appointment as Chief Special Master) as well as additional SIRVA cases
handled in chambers, I find it is not unusual for the information regarding site of
vaccination to be incorrect.4 In many instances, the information regarding situs is
recorded prior to vaccination, and is not updated, even if the vaccine is then administered
in the opposing arm.5 Thus, although such records are unquestionably the first-generated
documents bearing on issues pertaining to situs, they are not per se reliable simply
because they come first – and in fact the nature of their creation provides some basis for
not accepting them at face value.

       I note that despite the above, there is reason herein to give weight to the
vaccination form that supports a determination contrary to Petitioner’s contention. The
entry indicating site of vaccination on the record most specific to the disputed issue
required the pharmacist to manually circle the option “RA.” Information which requires
specific action on the part of the vaccine administrator is generally given greater weight
than information automatically generated within a computerized system. See, e.g.,
Rodgers v. Sec’y of Health & Hum. Servs., No. 18-0559V, 2020 WL 1870268, at *5 (Fed.
Cl. Spec. Mstr. Mar. 11, 2020). And because most individuals are right-hand dominant,
entries indicating a left arm administration may represent the nature default choice of the
vaccine administrator. See Mezzacapo v. Sec’y of Health & Hum. Servs., No. 18-1977V,
2021 WL 1940435, at *4 (Fed. Cl. Spec. Mstr. Apr. 19, 2021). Thus, the fact that a record
reveals that a provider circled the right arm “option” on a vaccination form, as here, should
be deemed significant – and in appropriate cases might be dispositive of the issue,
especially if corroborated by other evidence.

       Here, by contrast, the vaccine consent form is the only evidence in this case which
supports a finding of right arm situs. And there is also reason to think that the document
may have been completed prior to vaccination (at least the portion of this form which
contains Petitioner’s signature). Accordingly, given the general unreliability of these

4 See, e.g., Arnold v. Sec’y of Health & Hum. Servs., No. 20-1038V 2021 WL 2908519, at *4 (Fed. CL.
Spec. Mstr. June 9, 2021); Syed v. Sec’y of Health & Hum. Servs., No. 19-1364V, 2021 WL 2229829, at
*4-5 (Fed. Cl. Spec. Mstr. Apr. 28, 2021); Ruddy v. Sec’y of Health & Hum. Servs., No 19-1998V, 2021 WL
1291777, at *5 (Fed. Cl. Spec. Mstr. Mar. 5, 2021); Desai v. Sec’y of Health & Hum. Servs., No 14-0811V,
2020 WL 4919777, at *14 (Fed. Cl. Spec. Mstr. July 30, 2020); Rodgers v. Sec’y of Health & Hum. Servs.,
No. 18-0559V, 2020 WL 1870268, at *5 (Fed. Cl. Spec. Mstr. Mar. 11, 2020); Stoliker v. Sec’y of Health &
Hum. Servs., No. 17-0990V, 2018 WL 6718629, at *4 (Fed. Cl. Spec. Mstr. Nov. 9, 2018).

5In a recent ruling by another special master, the pharmacist who had administered the relevant vaccination
actually testified that she inputs “left deltoid” into the computer system as a matter of course, without
confirming the actual site of vaccination, based upon the assumption that most vaccinees are right-handed.
Mezzacapo v. Sec’y of Health & Hum. Servs., No. 18-1977V, 2021 WL 1940435, at *4 (Fed. Cl. Spec. Mstr.
Apr. 19, 2021).

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administration documents in the experience of SPU SIRVA cases, this evidence alone is
not sufficient to counter Petitioner’s clear, consistent, and close-in-time reports of left
shoulder pain after receiving the flu vaccine in her left arm on October 9, 2019.

   V.     Scheduling Order

      In August 2021, Petitioner was encouraged to finalize a demand and to obtain any
needed documentation to support the amounts sought. Order, issued Aug. 16, 2021, at
1, ECF No. 14. Additionally, I expect the HHS review in this case to be completed in late
May or early June 2022.

       Respondent shall file a status report providing his tentative position
regarding the merits of Petitioner’s claim or, at a minimum, an updated estimate of
the timing of the HHS review by no later than Tuesday, June 14, 2022. Petitioner
should continue to finalize her demand which she may convey to Respondent,
along with her supporting documentation, at any time.

IT IS SO ORDERED.

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

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