Dworkis v. Secretary of Health and Human Services ( 2022 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-1722V
UNPUBLISHED
ROSE DWORKIS, Chief Special Master Corcoran
Petitioner, Filed: July 18, 2022
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Findings of Fact; Onset; Lack of Prior
HUMAN SERVICES, Pain; Influenza (Flu) Vaccine;
Shoulder Injury Related to Vaccine
Respondent. Administration (SIRVA)
Phyllis Widman, Widman Law Firm, LLC, Northfield, NJ, for Petitioner.
Sarah Christina Duncan, U.S. Department of Justice, Washington, DC, for Respondent.
FINDINGS OF FACT1
On November 6, 2019, Rose Dworkis 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 right shoulder injury related to
vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccine received on
November 7, 2018, or, in the alternative, that the flu vaccine “significantly aggravated a
condition."3 Petition at 1. 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1 Because this unpublished Fact Ruling contains a reasoned explanation for the action in this case, I am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).
3 Petitioner did not set forth the condition alleged to have been aggravated in her Petition or in any
subsequent filing.
For the reasons discussed below, I find that although the medical record
establishes that Petitioner had no pre-vaccination history of right shoulder pain,
inflammation, or dysfunction that could explain her post-vaccination symptoms, her Table
SIRVA claim must be dismissed because the evidentiary record does not support the
conclusion that the onset of her pain occurred within 48 hours of vaccination. The claim
can therefore only (potentially) proceed as a causation-in-fact claim.
I. Relevant Procedural History
In his April 2, 2021 Rule 4(c) Report, Respondent argued that Petitioner’s injury
did not meet the definition for a Table SIRVA because she “had a history of gout,
inflammatory polyarthropathy, and arthritis prior to her November 7, 2018 flu vaccination.”
Rule 4(c) Report at 6. ECF No. 32. Respondent also argued that Petitioner has failed to
establish that her pain began within 48 hours of vaccination. Id. at 6-7. Lastly, Respondent
noted that Petitioner neither alleged nor established that her shoulder pain was caused-
in-fact by her November 2018 flu shot. Id. at 7-8.
In a Scheduling Order filed on April 19, 2021, I expressed the view that based on
review of the existing record, a hearing would not be necessary, and that I intended to
issue a fact finding as to the onset of Petitioner’s injury and whether Petitioner’s pre-
vaccination medical history explains her post-vaccination symptoms after providing the
parties an opportunity to file briefs and any evidence they wish to have considered. ECF
No. 33. Petitioner filed her brief on July 6, 2021, contending that she met her burden of
proof for both a Table SIRVA and off-Table claim. ECF No. 35. On August 4, 2021,
Respondent filed a response maintaining his position that this case should be dismissed,
and that I should issue a finding of fact to that end. ECF No. 36. This matter is now ripe
for resolution.
II. Issue
The following issues are contested: whether (1) Petitioner is able to satisfy the first
criterion of the Qualifications and Aids to Interpretation (“QAI”) for a Table SIRVA claim
which requires “[n]o 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;” and (2) Petitioner’s first symptom or manifestation of onset after vaccine
administration (specifically pain) occurred within 48 hours. 42 C.F.R. § 100.3(a) XIV.B.
(2017) (influenza vaccination). 42 C.F.R. § 100.3(c)(10)(i)-(ii)(no history of pain
requirement; required onset for pain listed in QAI).
2
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 as set forth in Section
11(c)(1). I have discussed the factors to be considered in determining whether a petitioner
has met their burden in several recent decisions. I fully adopt and hereby incorporate my
prior discussion in section III of the following decisions: Marrow v. Sec’y of Health &
Human Servs., No. 17-1964V, 2020 WL 3639775 (Fed. Cl. Spec. Mstr. June 2, 2020);
Robinson v. Sec’y of Health & Human Servs., No. 17-1050V, 2020 WL 3729432 (Fed. Cl.
Spec. Mstr. June 5, 2020); Decoursey v. Sec’y of Health & Human Servs., No.18-870V,
2020 WL 4673228 (Fed. Cl. Spec. Mstr. July 9, 2020).
In sum, 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 the petitioner’s injury or illness that is contained in a medical record.
Section 13(b)(1). Moreover, 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.IV. Findings of Fact
I have reviewed all of the records filed to date. This ruling, however, is limited to
determining (a) whether Petitioner had a pre-vaccination history of pain, inflammation or
dysfunction of her right shoulder that explains the shoulder symptoms she experienced
after her November 2018 flu shot; and (b) whether the onset of Petitioner’s right shoulder
pain was within 48 hours of her vaccination. Accordingly, I will only summarize or discuss
evidence that directly pertains to these issues.
• Petitioner’s medical history is significant for allergic rhinitis (beginning on June 24,
2013), acute pharyngitis (beginning on June 10, 2013), chronic hyperglycemia and
chronic vitamin D deficiency. See Ex. 3 at 2. Petitioner’s medical records do not
include any additional information concerning these conditions, including
Petitioner’s symptoms or treatment history.
3
• Petitioner’s medical history is also significant for uterovaginal prolapse, mild
diverticulosis, herpes zoster, postherpetic neuralgia (“PHN”), and hypertension.
See Ex. 3 at 2, 5, 7, 9, 11; Ex. 4 at 2-3, 4, 14, 16-17, 19, 22, 25, 26, 28.
• Petitioner’s medical records indicate that she was diagnosed with idiopathic gout
and inflammatory polyarthropathy in September 2014. See Ex. 3 at 2. Petitioner’s
medical records do not include any additional information concerning these
conditions, including Petitioner’s symptoms or treatment history.
• In her supplemental affidavit, signed on March 23, 2021, Petitioner avers that she
presented to the Bergen Kidney Center on September 11, 2014 due to left elbow
inflammation and tenderness. Ex. 9 at 1. Petitioner states that this condition was
determined to be gout and that “the inflammation was a one-time episode of short
duration and no further treatment was required.” Id.• It was noted on a medical summary sheet that on November 12, 2015, Petitioner’s
left elbow was described as hot, red, and tender. Ex. 3 at 2. She was noted to be
taking Aldactazide. Id.• Petitioner presented to Dr. Ivan A. Friedrich, her primary care physician, on August
2, 2018. Ex. 4 at 4. The medical note documenting this visit indicates that Petitioner
complained of arthritis, but denied back pain, gout, joint deformity, joint pain,
muscle weakness and stiffness. Id. at 5.
• An August 22, 2018 medical note indicates that Petitioner’s “[p]ertinent positive
symptoms include arthritis.” Ex. 4 at 26. Petitioner again denied back pain, gout,
joint deformity, joint pain, muscle weakness and stiffness. Id. at 27.
• On November 7 2018, Petitioner presented to Dr. Friedrich for follow up of her
PHN. Ex. 4 at 14-16. The medical note documenting this visit indicates that
Petitioner complained of numbness and tingling. Id. at 14. During this visit,
Petitioner was administered a flu shot in her right shoulder. Id. at 14; Ex. 1.
• In her affidavit, signed on June 24, 2019, Petitioner avers that “[w]ithin a few hours
of receiving the vaccine, I felt soreness and pain at the injection site as well as in
my upper arm. At the time I thought it was a normal reaction to the vaccine.” Ex. 2
at 1.
• Petitioner presented to Dr. Friedrich on January 16, 2019 (ten weeks post
vaccination) regarding PHN. Ex. 4 at 11-13. Although Dr. Friedrich later indicated
4
that Petitioner complained about shoulder pain on this date (see Ex. 8 at 1), the
contemporaneous medical record does not document any such statement. Id.• In her affidavit, Petitioner also states that she reported arm and shoulder pain
during her January 16, 2019 appointment with Dr. Friedrich. Ex. at 2 at 1. Petitioner
further indicates that although he instructed her to wait two months before following
up, on February 19, 2019, she asked him to refer her to an orthopedist. Id.• Petitioner presented to Dr. Michael Pizzillo at Englewood Orthopedic Associates
on March 6, 2019 with “a 3-month history of right shoulder pain.” Ex. 6 at 56. The
medical note indicates that Petitioner reported “insidious onset in November 2018.”
Id. She was assessed with impingement syndrome of the right shoulder and right
shoulder trapezius parascapular muscle spasm. Id. Formal physical therapy was
recommended. Id.• On March 12, 2019, Petitioner reported “pain in right arm/shoulder over the past
[four] months” to her physical therapist. Ex. 6 at 54. The note documenting this visit
indicates that Petitioner’s symptoms “may be related to a flu injection [four] months
ago.” Id.• A May 3, 2019 physical therapy note indicates that Petitioner reported “pain in right
upper arm/shoulder over the past 6 months.” Ex. 6 at 28. It was further indicated
that Petitioner’s symptoms were “possibly related to a flu injection around that
time.” Id.• On May 7, 2019, Petitioner presented to Dr. Pizzillo regarding a continuation of
right shoulder issues. Ex. 6 at 26-27. On exam, Petitioner’s right shoulder was
tender over the trapezius and the parascapular musculature, and her active range
of motion was “painful at the extremes of forward flexion and abduction.”
• Petitioner attended 30 sessions of physical therapy from March 12, 2019, through
July 9, 2019. Ex. 6 at 63-64. The final physical therapy note indicates that her right
arm and shoulder symptoms were possibly related to a flu vaccination. Id. at 63.
• Petitioner presented to Dr. Pizzillo on July 11, 2019. Ex. 6 at 61. She reported
“minimal complaints of pain with the exception of certain movements.” Id.Petitioner’s right shoulder exam revealed “near full and symmetric” range of
motion, a positive impingement sign, and good motor strength. Id.• Petitioner again presented to Dr. Friedrich on January 6, 2020. Ex. 7 at 2-5. Her
complaints included arthritis. Id. at 3.
5
A. Pre-Vaccination History
Respondent correctly asserts that Petitioner’s medical records reflect a pre-
vaccination history of gout, inflammatory polyarthropathy, and arthritis. However,
Respondent has not argued - and the medical records do not reflect - that these conditions
are connected to or explain Petitioner’s post-vaccination symptoms.
Petitioner acknowledges that she was diagnosed with gout in 2014. Brief at 2-3.
However, in addition to arguing that “the inflammation was a one-time episode” that
occurred three years prior to vaccination, she also notes that her symptoms were limited
to her left elbow. Id. This assertion is corroborated by a medical record indicating that
Petitioner’s left elbow was hot, red, and tender in November 2015, and there is no
indication that these symptoms extended to her vaccinated/right arm or shoulder. See Ex.
3 at 2.
Petitioner’s medical records offer no information concerning her 2014 inflammatory
polyarthropathy diagnosis, including its duration or symptoms. And while there is some
evidence that Petitioner generally complained about her arthritis, the medical records do
not reveal any specific information about its effect and there is no indication that this
condition had an impact on her right shoulder or arm. Therefore, I find that, on this record,
nothing in Petitioner’s pre-vaccination history would explain her post-vaccination
symptoms.
B. Onset
This case presents several issues regarding Petitioner’s success in establishing
onset consistent with the Table’s 48 hour requirement. First, there is an uncontroverted
ten-week gap from vaccination to Petitioner’s first documented report of shoulder pain,
which undermines somewhat Petitioner’s onset contentions. While some delay in seeking
treatment is relatively common in SIRVA cases, I have previously noted that “[i]t is
reasonable to expect the average Program claimant might seek medical treatment sooner
if in fact the person was experiencing sudden post-vaccination pain.” Pitts v. Sec’y of
Health & Human Servs., 18-1512V, 2020 WL 2959421, at *5 (Fed. Cl. Spec. Mstr. April
29, 2020).
This gap is compounded by the fact that Petitioner had an intervening medical visit
between her November 2018 flu shot and this first documented report of right shoulder
pain. Although Petitioner avers that she shared these issues seven weeks earlier, during
her January 16, 2019 appointment with Dr. Friedrich, the contemporaneously created
medical record is silent on the matter.
Petitioner has attempted to remedy this omission by submitting an August 11, 2020
medical record (authored by Dr. Friedrich) that clarifies what was spoken about at the
6
January 2019 appointment. However, this record makes no mention of when Petitioner’s
shoulder pain started. And while such after-the-fact statements can be deemed
persuasive (especially to the extent they do not contradict prior record statements), they
inherently are somewhat less probative than contemporaneous evidence. The fact that
the revising/amending statement about what was discussed was added and obtained
after the litigation had commenced is also unhelpful (although it does not necessarily
mean the subsequent statement is false).
Moreover, many record onset references are quite vague. For example, although
Petitioner maintains that the onset of her pain occurred “within a few hours” of vaccination,
on March 6, 2019, she reported “insidious onset in November 2018.” Ex. 6 at 56
(emphasis added).4 This generalized reference to the start of shoulder pain is also
reflected in a March 12, 2019 physical therapy record, noting that Petitioner’s four-month
history of right arm and shoulder pain “may be related to a flu injection four months ago.”
Id. at 54. See also Ex. 6 at 28 (May 3, 2019 physical therapy note documenting
Petitioner’s report of “pain in right upper arm/shoulder over the past 6 months . . . possibly
related to a flu injection around the same time”); Id. at 63 (July 9, 2019 physical therapy
note documenting Petitioner’s report of an eight-month history of right-sided pain that is
“possibly related to a flu injection around that time.”). While such language certainly
supports a finding that Petitioner suffered right-sided shoulder pain around the time she
received the flu shot, it does not support a finding that she more likely than not suffered
onset of her condition within 48 hours of her vaccination.
I acknowledge that the standard applied to resolving onset for an alleged SIRVA
is liberal and will often permit a determination in a petitioner’s favor, especially in the
absence of fairly contemporaneous and direct statements within the petitioner’s medical
records to the contrary. However, not every case can be so preponderantly established.
Ultimately, the resolution of such fact issues involves weighing different items of evidence
against the overall record.
Therefore, after considering the record as a whole, I find there is not preponderant
evidence to establish that Petitioner suffered the onset of symptoms within 48 hours of
her flu vaccination as required by the Vaccine Injury Table. 42 C.F.R. § 100.(3)(a)(I)(C).
Although Petitioner asserted in her brief that, alternatively, her injury was caused-
in-fact by the November 2018 flu vaccination, she has to date failed to provide any support
for this claim. However, the record does support onset having occurred shortly after
vaccination and, seemingly, all other criteria for a Table SIRVA claim appear satisfied.
Therefore, Petitioner very likely has a viable non-SIRVA claim. To that end, I urge the
4This record also indicates that Petitioner reported a three-month history of shoulder pain - which would
date back to December 6, 2018. However, given that Petitioner specifically reported a November 2018
onset, it appears that this is simply an error in calculation.
7
parties to make one final brief attempt at settlement – as I would anticipate that even after
transfer, Petitioner’s claim could prove meritorious despite her inability to meet one Table
element.
V. Scheduling Order
Petitioner has not preponderantly established that the onset of her pain occurred
within 48 hours of vaccination. Accordingly, the Table SIRVA claim is DISMISSED,
although Petitioner may pursue the claim as a non-Table, causation-in-fact claim. The
parties shall file a status report on or before Wednesday, August 17, 2022, regarding
their settlement efforts. The matter shall be transferred thereafter if the parties do not
report significant progress in reaching an agreement at that time.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
8