Court Opinion

ID: 8212114
Source: CourtListenerOpinion
Date Created: 2022-10-06 13:01:31.08349+00
Date Added: 2024-06-11T16:42:08.014906
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                           No. 21-1251V
                                          UNPUBLISHED

    ANNE ZARATSIAN,                                             Chief Special Master Corcoran

                         Petitioner,                            Filed: August 23, 2022
    v.
                                                                Special Processing Unit (SPU);
    SECRETARY OF HEALTH AND                                     Findings of Fact; Site of Vaccination
    HUMAN SERVICES,                                             Tetanus, Diphtheria, acellular
                                                                Pertussis (Tdap) Vaccine; Shoulder
                         Respondent.                            Injury Related to Vaccine
                                                                Administration (SIRVA)

Howard Dale Mishkind, Mishkind Kulwicki Law Co., L.P.A., Cleveland, OH, for
     Petitioner.

Rachelle Bishop, U.S. Department of Justice, Washington, DC, for Respondent.

                                           FINDINGS OF FACT1

       On April 19, 2021, Anne Zaratsian 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”), as defined in the Vaccine Table, after receiving the tetanus,
diphtheria, acellular pertussis (“Tdap”) vaccine on September 9, 2020. Petition at 1, ¶¶ 2,
4, 12.

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  Because this unpublished Fact Ruling contains a reasoned explanation for the action in this case, I am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 the Tdap vaccine was most likely
administered in Petitioner’s left deltoid, as alleged.

          I.     Relevant Procedural History

       Not long after the case’s initiation, Ms. Zaratsian filed the affidavit and medical
records required under the Vaccine Act to support her claim. Exhibits 1-3, ECF Nos. 1, 7;
see Section 11(c). On October 15, 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.

        On December 6, 2021, Petitioner was ordered to file any additional records
indicating the site of vaccination – information which was lacking on the filed vaccine
record. ECF No. 14. In response, Petitioner provided a letter from her primary care
provider, dated on December 22, 2021, indicating that Petitioner received the Tdap
vaccine intramuscularly in her left deltoid on September 9, 2020. Exhibit 4, filed Dec. 27,
2021, ECF No. 17. After Respondent’s counsel questioned the sufficiency of this letter,
Petitioner provided a second letter, containing a more detailed accounting of the facts
surrounding the vaccination. Exhibit 5, filed May 22, 2022, ECF No. 21 (letter dated May
19, 2022).

        In response to an email communication from the OSM staff attorney assisting me
on this SPU case, the parties confirmed that they did not wish to add any further evidence
or briefing regarding the situs issue. See Informal Remark, dated Aug. 8, 2022. The matter
is now ripe for adjudication.

          II.    Issue

       At issue is whether Petitioner received the vaccination alleged as causal in her
injured 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

                                            2
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.
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

                                             3
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 these findings after a complete review of the record, which includes all
medical records, affidavits, and additional evidence filed. Specifically, I highlight the
following:

          •     Prior to vaccination, Petitioner suffered from common illnesses and
                conditions. Exhibit 2 at 6-213. In 2020, Petitioner was also being seen
                routinely by medical treaters because she was pregnant with her third child.
                Id. at 68 (listing two prior births).

          •     While still pregnant on September 9, 2020, Petitioner received the Tdap
                vaccine alleged as causal. Exhibit 2 at 214, 226. The vaccine record
                provides the date, type, lot number, and method of administration
                (intramuscularly) of vaccination and individual administering it. The record
                does not identify the site of vaccination. Id.

          •     Approximately two weeks post-vaccination on September 21st, Petitioner
                called her primary care provider (“PCP”), complaining of shoulder pain after
                receiving the Tdap vaccine on September 9th. Exhibit 2 at 232. She
                indicated that her pain began “that same day and . . . has not subsided.” Id.
                The location of Petitioner’s pain was listed as the “injection site.” Id. at 234;
                accord. id. at 236. Petitioner indicated that when she received vaccination,
                “the nurse stuck her twice because the first time was too high/needle wasn’t
                working.” Id. at 236. She requested a referral for treatment of this injury. Id.
                at 232.

          •     The next day on September 22nd, Petitioner was seen by her PCP for pain
                at the injection site of her left arm/shoulder. Exhibit 2 at 239. Reporting the

                                                4
    same account of being stuck twice, Petitioner added that the nurse
    administering the vaccine was shaky and injected the vaccine “near [the]
    top of [the] shoulder joint.” Id. Petitioner was assessed as having acute pain
    of the left shoulder and pain at the injection site. Id. at 240. After checking
    with her obstetrician, Petitioner was prescribed a Medrol dose pack. Id. at
    246.

•   At her prenatal visit the next day on September 23rd, Petitioner reported arm
    soreness from the Tdap vaccine she received two weeks earlier. Exhibit at
    256.

•   An ultrasound of Petitioner’s left shoulder was performed on September
    23rd. Exhibit 2 at 265-67. Despite normal results, the nurse practitioner
    reviewing the ultrasound opined Petitioner was suffering from an injury
    caused form of tendinitis, rather than any chronic issues. Id. at 269.
    Petitioner was instructed to take the oral steroids prescribed byher PCP the
    previous day. Id. at 270.

•   The next day on September 24th, Petitioner remotely attended an
    appointment with the nurse practitioner. Exhibit 2 at 272. Her left shoulder
    pain was again attributed to her Tdap vaccination, and the same detailed
    history of the administration – including two attempts and a too-high
    injection, was included in this record. Id.

•   On September 25th, Petitioner was seen by an orthopedist for “left shoulder
    pain after receiving a TD vaccine.” Exhibit 2 at 281. She again reported
    achiness which began with her Tdap vaccine and progressively worsened
    thereafter. Id. at 279. She received a second cortisone injection. Id. at 281,
    284-87.

•   Petitioner reported that her left shoulder pain was gradually improving
    during a remote appointment on September 30, 2020. Exhibit 2 at 291

•   A few days after giving birth on October 30, 2020, Petitioner inquired by
    phone, for additional treatment of her shoulder pain. Exhibit 2 at 570 (call
    on November 6, 2020. She indicated that the second cortisone injection was
    wearing off, and she did not want to wait too long before pursuing additional
    treatment. Id.

                                   5
          •    On December 2nd, Petitioner participated in a remote orthopedic
               appointment for her left shoulder pain. Exhibit 2 at 617. The next day, she
               attended a physical therapy evaluation. Exhibit 3 at 36. Petitioner continued
               PT through mid-April 2021. Exhibit 3 at 4 (last PT session on April 14th).

          •    In her affidavit, executed on April 17, 2021, Petitioner indicated that she
               received the Tdap vaccine in her left deltoid on September 9, 2020, when
               visiting her obstetrician. Exhibit 1 at ¶ 3.

       The above medical entries show that, when seeking treatment for her left shoulder
pain, Petitioner consistently attributed her pain to the Tdap vaccine she reported receiving
in her left arm. She provided these histories to her PCP, obstetrician, and orthopedist.
While originating from Petitioner, these statements are memorialized 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, and even
though the record in question simply memorializes what the petitioner said at the time, its
contemporaneous nature makes it somewhat more trustworthy than after-the-fact witness
statements prepared in connection with this matter.

        The vaccine record clearly establishes that Petitioner received a Tdap vaccine on
September 9, 2020. Thereafter, when seeking medical care for her left shoulder pain,
Petitioner consistently attributed the source of her pain to the Tdap vaccine she described
as improperly administered in her left deltoid. There is a dearth of evidence that the
vaccine was administered in any other location. I thus determine, based on the record as
a whole, that preponderant evidence establishes that the Tdap vaccine to which Petitioner
attributes her SIRVA was most likely administered in her left deltoid on September 9,
2020.

          V.      Scheduling Order

       I expect the HHS review in this case to be completed in late 2022. While awaiting
the review, Petitioner should finalize a demand and should convey the demand, along
with any supporting documentation, to Respondent.

       Petitioner shall file any updated medical records and a status report
regarding her demand, supporting documentation, and current condition by no
later than Wednesday, September 28, 2022.

                                             6
      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 and assessment of the completeness of the
supporting documentation for any conveyed demand by no later than Friday,
October 28, 2022.

IT IS SO ORDERED.

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

                                        7