Court Opinion

ID: 7800350
Source: CourtListenerOpinion
Date Created: 2022-08-12 21:02:50.564941+00
Date Added: 2024-06-11T16:29:04.619653
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                           No. 19-1449V
                                          UNPUBLISHED

    KATHLEEN CARLOW,                                             Chief Special Master Corcoran

                          Petitioner,                            Filed: July 12, 2022
    v.
                                                                 Special Processing Unit (SPU);
    SECRETARY OF HEALTH AND                                      Entitlement to Compensation; Table
    HUMAN SERVICES,                                              Injury; Decision Awarding Damages;
                                                                 Pain and Suffering; Influenza (Flu)
                         Respondent.                             Vaccine; Shoulder Injury Related to
                                                                 Vaccine Administration (SIRVA)

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

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

          RULING ON ENTITLEMENT AND DECISION AWARDING DAMAGES1

      On September 19, 2019, Kathleen Carlow filed a petition for compensation under
the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the
“Vaccine Act”), alleging that she suffered a Shoulder Injury Related to Vaccine
Administration (“SIRVA”) as a result of an influenza (“flu”) vaccine administered to her on
September 20, 2016. Petition, ECF No. 1 at 1. The case was assigned to the Special
Processing Unit of the Office of Special Masters (the “SPU”).

      For the reasons described below, and after holding a brief hearing on entitlement
and damages in this matter, I find that Petitioner is entitled compensation, and I award
damages in the total amount of $83,410.29, consisting of $77,500.00 for Petitioner’s

1
  Although I have not formally designated this Decision for publication, I am required to post it on the United
States Court of Federal Claims' website in accordance with the E-Government Act of 2002, because it
contains a reasoned explanation for my determination. 44 U.S.C. § 3501 note (2012) (Federal Management
and Promotion of Electronic Government Services). This means the Decision 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).
actual pain and suffering, and $5,910.29 for Petitioner’s out-of-pocket medical
expenses.

      I.      Relevant Procedural History

       As noted above, this case was initiated in September 2019. On May 17, 2021, after
attempting to resolve this case informally, Petitioner filed a status report stating that the
parties had reached an impasse. (ECF No. 23). The parties requested that I issue a
scheduling order setting deadlines for the parties to brief both the issues of entitlement
and damages, and I did so. (ECF No. 24).

       On July 22, 2021, Petitioner filed a Motion for Ruling on Record and Brief in support
of Damages (“Motion”), arguing that she had established entitlement to compensation for
her SIRVA injury, and requesting $80,000.00 for her past/actual pain and suffering plus
$6,875.29 for her out-of-pocket medical expenses. (ECF No. 26). Petitioner specifically
asserted that the evidence in the record preponderantly established that she received a
vaccine in her left shoulder on September 20, 2016, that her shoulder injury began within
48 hours of receiving the vaccine, and that she was therefore entitled to compensation.
Id.

        Respondent filed a combined Rule 4(c) Report and Response to Petitioner’s
Motion on August 23, 2021 (“Response”) recommending that entitlement to compensation
be denied under the terms of the Vaccine Act. (ECF No. 26). Respondent argued that the
Table criterion for SIRVA that required that pain and reduced range of motion be limited
to the shoulder in which the intramuscular vaccine was administered had not been met in
this case. Id. at 8. Respondent further asserted that Petitioner had not provided evidence
sufficient to establish causation-in-fact under the relevant standard. Id. at 8-12. Petitioner
filed his Reply on September 7, 2021. (ECF No. 28).

       In May of this year, I proposed this case be set for an expedited “Motions Day”
hearing on June 23, 20223, at which time I would decide the disputed issues based on all
evidence filed to date and any oral argument from counsel. (ECF No. 30). The parties
agreed. (ECF No. 31). The Motions Day hearing took place on July 8, 2022. Minute Entry
dated July 11, 2022. After the argument, I orally ruled on Petitioner’s entitlement to
compensation and made a damages determination as well. This Decision memorializes
those findings/determinations.

3
    The hearing was subsequently rescheduled and heard on July 8, 2022.

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    II.      Factual Findings and Ruling on Entitlement

             A. Legal Standards

       Before compensation can be awarded under the Vaccine Act, a petitioner must
demonstrate, by a preponderance of evidence, all matters required under Section
11(c)(1), including the factual circumstances surrounding his claim. Section 13(a)(1)(A).
In making this determination, the special master or court should consider the record as a
whole. Section 13(a)(1). Petitioner’s allegations must be supported by medical records or
by medical opinion. Id.

        To resolve factual issues, the special master must weigh the evidence presented,
which may include contemporaneous medical records and testimony. See Burns v. Sec'y
of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special
master must decide what weight to give evidence including oral testimony and
contemporaneous medical records). Contemporaneous medical records are presumed to
be accurate. See Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed.
Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a
petitioner may present testimony which is “consistent, clear, cogent, and compelling.”
Sanchez v. Sec'y of Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Human Servs., No.
90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)).

       In addition to requirements concerning the vaccination received, the duration and
severity of petitioner’s injury, and the lack of other award or settlement,4 a petitioner must
establish that she suffered an injury meeting the Table criteria, in which case causation
is presumed, or an injury shown to be caused-in-fact by the vaccination she received.
Section 11(c)(1)(C).

        The most recent version of the Table, which can be found at 42 C.F.R. § 100.3,
identifies the vaccines covered under the Program, the corresponding injuries, and the
time period in which the particular injuries must occur after vaccination. Section 14(a).
Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests within 48
hours of the administration of a flu vaccine. 42 C.F. R. § 100.3(a)(XIV)(B). The criteria
establishing a SIRVA under the accompanying QAI are as follows:

4
 In summary, a petitioner must establish that he received a vaccine covered by the Program, administered
either in the United States and its territories or in another geographical area but qualifying for a limited
exception; suffered the residual effects of his injury for more than six months, died from his injury, or
underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected
an award or settlement for her injury. See § 11(c)(1)(A)(B)(D)(E).

                                                        3
      Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests
      as shoulder pain and limited range of motion occurring after the
      administration of a vaccine intended for intramuscular administration in the
      upper arm. These symptoms are thought to occur as a result of unintended
      injection of vaccine antigen or trauma from the needle into and around the
      underlying bursa of the shoulder resulting in an inflammatory reaction.
      SIRVA is caused by an injury to the musculoskeletal structures of the
      shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological
      injury and abnormalities on neurological examination or nerve conduction
      studies (NCS) and/or electromyographic (EMG) studies would not support
      SIRVA as a diagnosis (even if the condition causing the neurological
      abnormality is not known). A vaccine recipient shall be considered to have
      suffered SIRVA if such recipient manifests all of the following:

      (i) No history of pain, inflammation or dysfunction of the affected shoulder
      prior to intramuscular vaccine administration that would explain the alleged
      signs, symptoms, examination findings, and/or diagnostic studies occurring
      after vaccine injection;

      (ii) Pain occurs within the specified time frame;

      (iii) Pain and reduced range of motion are limited to the shoulder in which
      the intramuscular vaccine was administered; and

      (iv) No other condition or abnormality is present that would explain the
      patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy,
      brachial neuritis, mononeuropathies, or any other neuropathy).

42 C.F.R. § 100.3(c)(10).

          B. Factual Finding Regarding QAI Criteria for Table SIRVA

        The only Table requirement for SIRVA that Respondent contests is the third
criterion, i.e., whether Petitioner’s pain and reduced range of motion were limited to her
left shoulder. Response at 8. Based upon a review of the entire record, and for the
reasons set forth below, I find that it likely was.

        Respondent asserts that Petitioner’s pain and reduced range of motion were not
“limited to the shoulder in which the intramuscular vaccine was administered” because of
multiple references in the record where Petitioner complained of pain radiating down her
arm and into her hand the same day as she received her flu vaccine, as well as later

                                            4
during her treatment course. See, e.g., Ex. 3 at 450; Ex. 4 at 1-2; Ex. 4 at 4-5, Ex. 9 at 2.
Even though the record does establish these instances of non-shoulder pain complaints,
I generally credit Petitioner’s argument that her pain originated in her left shoulder and
did not originate from another source. Reply at 2. And this is not a case where the bulk of
Petitioner’s complaints included an area broader than the shoulder region. On the
contrary - the vast majority of records concentrate on Petitioner’s complaints and
treatment for left shoulder pain. See, e.g., Ex. 2 at 208 (“Pain is located anterior
shoulder…”), Ex. 4 at 2 (“She has very restricted glenohumeral movement at the left
shoulder.”); Ex. 8 at 7 (“[P]atient reports in the last three weeks she has been experiencing
increased discomfort throughout the left shoulder…”); Ex. 8 at 13 (showing left shoulder
range of motion restrictions). Petitioner was diagnosed with adhesive capsulitis by at least
three different providers, including Dr. Anthony Jesser, her orthopedic specialist. Ex. 4 at
59, 61-63, 66; Ex. 5 at 1-3. And to the extent that brachial neuritis was considered,
subsequent testing ruled out that diagnosis. Ex. 4 at 18-19, 46-48.

       At most, instances of complaints of pain in an area outside of the shoulder region
are relevant to Petitioner’s damages. But they do not defeat an otherwise-meritorious
SIRVA claim – especially where there is ample and preponderant evidence of consistent,
primary shoulder pain. Accordingly, this element of the claim has been met.

            C. Other Requirements for Entitlement

       As stated above, I find that Petitioner has satisfied all requirements for a Table
SIRVA and is entitled to a presumption of causation. Even if a petitioner has satisfied the
requirements of a Table injury or established causation-in-fact, he or she must also
provide preponderant evidence of the additional requirements of Section 11(c), i.e.,
receipt of a covered vaccine, residual effects of injury lasting six months, etc. See
generally § 11(c)(1)(A)(B)(D)(E). But those elements are established or undisputed. I
therefore find that Petitioner is entitled to compensation in this case.

            D. Damages

                    a. The Parties’ Arguments
       Citing seven5 prior damages determinations, Petitioner requests $80,000.00 in
actual pain and suffering. Motion at 2. She asserts that her course of treatment (including

5
 Petitioner discusses the following cases in her Motion: Binette v. Sec’y of Health & Human Servs., No. 16-
0731V, 2019 WL 1552620 (Fed. Cl. Spec. Mstr. Mar. 20, 2019) (Special Master Dorsey); Desai v. Sec’y of
Sec’y of Health & Human Servs., No. 14-811v, 2021 WL 1292753 (Fed. Cl. Spec. Mstr. March 1, 2021)
(Special Master Gowen), Cooper v. Sec’y of Sec’y of Health & Human Servs., No. 16-1387; Young v. Sec’y
of HHS, No. 15-1241V, 2019 U.S. Claims LEXIS 37 (Fed. Cl. Jan. 4, 2019), Dhanoa v. Sec’y of Sec’y of
Health & Human Sers., No. 15-1011V, 2018 WL 1221922 (Fed. Cl. Spec. Mstr. Feb.1, 2018); Kent v. Sec’y

                                                    5
two EGM studies, an X-ray, MRI, steroid injection, and multiple rounds of physical
therapy), is comparable to the aforementioned non-surgical SIRVA cases and warrants
an award at that level. Motion at 1-2, 16-20. Specifically, Petitioner argues that she is
entitled to an award similar to the award the petitioner received in Binette6 as “both
Petitioners experienced moderate to severe shoulder injuries from vaccine administration
that continued for several years.”7 Motion at 20. Petitioner also emphasizes that her
medical records demonstrate that she endured pain and suffering for nearly three years,
and that her symptoms continued to interfere with her ability to care for her young child
and perform activities of daily living. Motion at 23-24; Ex. 10 at 1-2.
       Respondent, by contrast, proposes an award of no more than $65,000.00 for
Petitioner’s pain and suffering. Response at 10, 12. He argues that “Petitioner’s medical
records reflect that she sustained a comparatively minor injury and received some
conservative treatment.” Id. at 10. Respondent cites to one case in particular – Knauss v.
Sec’y of Health & Human Servs., No. 16-1372V, 2018 WL 343296 (Fed. Cl. Spec. Mstr.
Ma 23, 2018) – in which petitioner received $60,000.00 for pain and suffering. But Ms.
Carlow’s course of treatment was longer that Mr. Knauss’s course of treatment, justifying
a slight increase on what was awarded in Knauss. Response at 11.

                   b. Legal Standards for Damages Awards
      In another recent decision, I discussed at length the legal standard to be
considered in determining damages and prior SIRVA compensation within SPU. I fully
adopt and hereby incorporate my prior discussion in Sections II and III of Berge v. Sec’y
Health & Human Servs., No. 19-1474V, 2021 WL 4144999, at *1-3. (Fed. Cl. Spec. Mstr.
Aug. 17, 2021).

        In sum, compensation awarded pursuant to the Vaccine Act shall include “[f]or
actual and projected pain and suffering and emotional distress from the vaccine-related
injury, an award not to exceed $250,000.” Section 15(a)(4). The petitioner bears the
burden of proof with respect to each element of compensation requested. Brewer v. Sec’y
of Health & Human Servs., No. 93-0092V, 1996 WL 147722, at *22-23 (Fed. Cl. Spec.
Mstr. Mar. 18, 1996). Factors to be considered when determining an award for pain and

of Health & Human Servs., No. 17-0073V, 2019 WL 5579493 at 2 (Fed. Cl. Aug. 7, 2019); Goring v. Sec’y
of Health & Hum. Servs., No. 16-1458V, 2019 WL 6049009 (Fed. Cl. Spec. Mstr. Aug. 23, 2019).
6
 Binette v. Sec’y of Health & Human Servs., No. 16-0731V, 2019 WL 1552620, *12 (Fed. Cl. Spec. Mstr.
Mar. 20, 2019).
7
 The petitioner in Binette was awarded $130,000.00 in pain and suffering by former Chief Special Master
Dorsey. 2019 WL 1552620, *12.

                                                   6
suffering include: 1) awareness of the injury; 2) severity of the injury; and 3) duration of
the suffering. 8

                   c. Appropriate Compensation for Pain and Suffering

       In this case, awareness of the injury is not disputed. The record reflects that at all
times Petitioner was a competent adult with no impairments that would impact her
awareness of his injury. Therefore, I analyze principally the severity and duration of
Petitioner’s injury. When performing this analysis, I review the same record relied upon
to determine entitlement, including the filed affidavits and medical records, written briefs,
and argument at the Motions Day hearing. I have also considered prior awards for pain
and suffering in both SPU and non-SPU SIRVA cases, and rely upon my experience
adjudicating these cases.

        The amount awarded for pain and suffering in this case takes special notice of the
fact that Petitioner was pregnant at the time she received the vaccine, and therefore could
not take advantage of the typical treatment of a shoulder injury such as prescription pain
medications, steroids injections, and surgery. And then the subsequent burdens of caring
for her newborn child while suffering from the SIRVA injury compounded her suffering.

       Thus, in her affidavit, Ms. Carlow describes her frustration and the difficultly she
encountered after her daughter was born. Pet. Ex. 10 at 1. She describes how difficult it
was to nurse her newborn child and to pick her up from her crib, setting and putting her
into her car seat, and breastfeeding. Id. After giving birth, Petitioner attended multiple
rounds of physical therapy. Ex. 3 at 608, 630, 640, 651, 661; Ex. 4 at 23-24, 71; Ex. 8 at
1-6.11-13 She underwent an X-ray, MRI and several EMG studies of her left shoulder
and was diagnosed with adhesive capsulitis. Ex. 4 at 1-2; Ex. 5 at 1-2. Nearly nine months
after giving birth in November 2016, Ms. Carlow received a steroid injection in her left
shoulder. Ex. 4 at 62. Her physician, Dr. Mercer, told her that recovery “will be slow…”
Ex. 4 at 59. The most medical records dated August 16, 2019, noted “[p]ositive for
arthralgias (shoulder)…”, evidence of an ongoing shoulder injury nearly three years after
vaccination. The pain and suffering award considers these specific facts and
circumstances.

       The parties’ comparable case citations were reasonable, but not fully useful in
helping me to calculate pain and suffering. I find that Petitioner’s SIRVA more closely
resembles the injury suffered by the petitioner in a case that was not cited by either party,

8
 I.D. v. Sec’y of Health & Human Servs., No. 04-1593V, 2013 WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May
14, 2013) (quoting McAllister v. Sec’y of Health & Human Servs., No 91-1037V, 1993 WL 777030, at *3
(Fed. Cl. Spec. Mstr. Mar. 26, 1993), vacated and remanded on other grounds, 70 F.3d 1240 (Fed. Cir.
1995)).

                                                  7
but also involves a petitioner that was pregnant at the time of vaccination. Desrosiers v.
Sec’y of Health & Human Servs., No. 16-0224V, 2017 WL 55078045, (Fed. Cl. Sept. 19,
2017). Because of her pregnancy, the Desrosiers petitioner similarly complained that she
was unable to avail herself of traditional treatment options such as NSAIDS, steroid
injections, and imaging because she was pregnant. Desrosiers, 2017 WL 55078045, at
*5. And like Ms. Carlow, that petitioner also complained of difficulty in caring for her
newborn son after birth due to the limitations with her shoulder. The Desrosiers petitioner
was awarded $85,000.00 for her pain and suffering.

       Under such circumstances, and considering the arguments presented by both
parties, a review of the cited cases, and based on the record as a whole, I find that
$77,500.00 in compensation for Ms. Carlow’s actual pain and suffering is reasonable and
appropriate in this case. Although Petitioner’s request for $80,000.00 is reasonable, and
consistent with the “best” comparable in my view, I will discount this award slightly to
account for the fact that Ms. Carlow complaints of pain were not wholly reflective of a
SIRVA, but included non-compensable problems like pain radiating to her hand. I
therefore award Petitioner $77,500.00 for her actual pain and suffering.

                 d. Award for Past Unreimbursed Expenses

       Ms. Carlow originally requested $6,875.29 in past unreimbursable expenses.
Motion at 24. Respondent, however, proposed only reimbursing Petitioner a total of
$5,910.29, disputing $965.00 for a “specialty mattress for back pain” from Tuft & Needle,
arguing that Petitioner had not established the reasonable necessity of the expense as
required under Section 15 of the Vaccine Act. 42 U.S.C. § 300aa-15(a)(1)(B). During the
hearing, however, Petitioner formally withdrew her request for reimbursement of that cost,
leaving $5,910.29 for her out-of-pocket medical expenses as a sum neither side disputes.
Because I find the costs reflected in that sum to be reasonable, I award Ms. Carlow
$5,910.29 for past unreimbursable expenses.

          E. Conclusion

       In light of all of the above, the I award Petitioner a lump sum payment of
$83,410.29, (representing $77,500.00 for Petitioner’s actual pain and suffering and
$5,910.29 for unreimbursable medical expenses) in the form of a check payable to
Petitioner, Kathleen Carlow. This amount represents compensation for all damages that
would be available under Section 15(a) of the Vaccine Act. Id.

                                            8
        This amount represents compensation for all damages that would be available
under Section 15(a). The Clerk of the Court is directed to enter judgment in accordance
with this Decision.9

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

9
  Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice
renouncing the right to seek review.

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