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

In the United States Court of Federal Claims
f
OFFICE OF SPECIAL MASTERS
No. 18-181V
Filed: October 5, 2022
PUBLISHED
Special Master Horner
ERIN CODY,
Petitioner, Shoulder Injury Related to
v. Vaccine Administration
(“SIRVA”); Influenza (“Flu”)
SECRETARY OF HEALTH AND Vaccine; Table Injury; Ruling on
HUMAN SERVICES, the Record
Respondent.
Michael Patrick Milmoe, Law Offices of Leah V. Durant, PLLC, Washington, DC, for
petitioner.
Nancy Tinch, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT 1
On February 6, 2018, petitioner, Erin Cody, filed a petition under the National
Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), 2 alleging that her receipt
of an influenza vaccination on December 31, 2016, caused a right shoulder injury.
(ECF No. 1.) For the reasons set forth below, I conclude that petitioner is entitled to an
award of compensation.
I. Applicable Statutory Scheme
Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
1
Because this ruling contains a reasoned explanation for the special master’s action in this case, it will be
posted on the United States Court of Federal Claims’ website in accordance with the E-Government Act
of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the 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 the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
2
All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-
10-34.
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including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination also specified in the Table. If so, the
Table Injury is presumed to have been caused by the vaccination, and the petitioner is
automatically entitled to compensation, unless it is affirmatively shown that the injury
was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300 aa-
11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
As relevant here, the Vaccine Injury Table lists a Shoulder Injury Related to
Vaccine Administration or “SIRVA” as a compensable injury if it occurs within 48 hours
of administration of an influenza vaccine. § 300aa-14(a) as amended by 42 C.F.R. §
100.3. Table Injury cases are guided by statutory “Qualifications and aids in
interpretation” (“QAIs”), which provide more detailed explanation of what should be
considered when determining whether a petitioner has actually suffered an injury listed
on the Vaccine Injury Table. 42 C.F.R. § 100.3(c). To be considered a “Table SIRVA,”
petitioner must show that his injury fits within the following description:
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 . . . . 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
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(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).
Vaccine Program petitioners must establish their claim by a “preponderance of
the evidence”. § 300aa-13(a). That is, a petitioner must present evidence sufficient to
show “that the existence of a fact is more probable than its nonexistence . . . .” Moberly
v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010).
Petitioner may not receive a Vaccine Program award based solely on her assertions;
rather, the petition must be supported by either medical records or by the opinion of a
competent physician. § 300aa-13(a)(1).
II. Procedural History
This case was originally assigned to the Special Processing Unit (“SPU”). (ECF
No. 6.) Petitioner filed a Statement of Completion on April 2, 2018. (ECF No. 11.) On
October 24, 2018, respondent indicated an interest in discussing settlement. (ECF No.
21.) However, the parties were unable to resolve the case after extended discussions,
prompting respondent to file his Rule 4 report on March 20, 2020, and the case to
subsequently be reassigned Special Master Roth on July 15, 2020. (ECF Nos. 49, 54.)
When respondent filed his Rule 4 report, he contended that petitioner could not
demonstrate a Table SIRVA for two reasons. First, he indicated that there is not
preponderant evidence of onset of shoulder pain occurring within 48 hours of
vaccination. (ECF No. 49, p. 8.) Second, he contended that petitioner’s pain and
reduced range of motion were not limited to the shoulder in which she received her
vaccination. (Id. at 9.)
While the case was pending before Special Master Roth, petitioner filed a letter
by one of her treating physicians, Catherine Troy, as well as several witness
declarations, and an expert report by orthopedist Uma Srikumaran, M.D. (ECF Nos. 51,
57.) The case was subsequently reassigned to me on January 29, 2021. (ECF No. 65.)
At the time the case was reassigned, respondent had a pending deadline for the filing of
a responsive expert report. However, shortly after the reassignment, respondent filed a
motion seeking to take the deposition of Dr. Troy, arguing that the letter she supplied to
petitioner contradicted her contemporaneous medical records. (ECF No. 66.)
Respondent requested his expert report deadline be suspended pending this discovery.
(Id.)
I held a status conference on February 16, 2021. (ECF No. 67.) I granted
respondent’s motion in part and denied it in part, rejecting respondent’s request for a
deposition but allowing respondent to issue written interrogatories and seek a complete
copy of petitioner’s patient file with Dr. Troy. (Id.) I also denied respondent’s request to
stay his expert report deadline, explaining that the medical issue raised by respondent
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(whether the pain and reduced range of motion were limited to the shoulder in question)
was not dependent upon the discovery he sought, which pertained to onset only. (Id.)
In lieu of filing an expert report, respondent filed an amended Rule 4 report on
March 8, 2021. (ECF No. 70 (docketed as a Status Report).) In the amended report,
respondent “agrees that petitioner’s pain was limited to her vaccinated arm, but
respondent does not agree that petitioner’s symptoms began within the Table timeframe
for SIRVA.” (Id. at 2.) On April 9, 2021, respondent filed Dr. Troy’s interrogatory
responses and patient file. (ECF No. 71; Exs. A-B.)
Following this discovery, respondent renewed his request to depose Dr. Troy.
(ECF No. 72.) I subsequently advised, however, that my preliminary view was that the
case would not turn on Dr. Troy’s testimony. I instructed petitioner to file a motion for a
ruling resolving entitlement on the written record and indicated that respondent could
address his request to depose Dr. Troy in his response “thereby raising the question for
resolution in the entitlement decision.” (ECF No. 74.)
Petitioner filed her motion for a ruling on the record on September 24, 2021.
(ECF No. 78.) Respondent filed his response on November 10, 2021. (ECF No. 80.)
Petitioner filed a reply on December 3, 2021. (ECF No. 83.) As briefed by the parties,
the only issue to be resolved is the initial onset of petitioner’s condition. Respondent
noted the fact that his prior request to depose Dr. Troy had been denied, but did not
renew his request in his brief or include any argument as to why Dr. Troy’s testimony is
necessary to resolve entitlement. (ECF No. 80, p. 6 n.3.)
I have determined that the parties have had a full and fair opportunity to present
their cases and that it is appropriate to resolve this issue without a hearing. See
Vaccine Rule 8(d); Vaccine Rule 3(b)(2); Kreizenbeck v. Sec’y of Health & Human
Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (noting that “special masters must
determine that the record is comprehensive and fully developed before ruling on the
record.”). Accordingly, this matter is now ripe for resolution.
III. Factual History
a. As reflected in the medical records
Petitioner had an extensive course of treatment for her alleged shoulder injury
and most of the records generated in the course of that treatment do not specifically
address the initial onset of the condition. Accordingly, only select medical records
directly bearing on the question of onset are discussed. Most notably, that includes all
of the encounter records generated during the months leading up to petitioner’s initial
report and treatment of her injury as well as subsequently generated records that
include histories of onset elicited from petitioner. Petitioner received the vaccination at
issue in her right deltoid on December 31, 2016. (Ex. 1, p. 1.)
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i. Treatment with primary care physician
Three days after her vaccination, petitioner presented to Dr. Catherine Troy, her
primary care physician, for an annual physical exam. (Ex. 5, pp. 1-2.) Petitioner
reported a history of heart burn and a resolved cough as well as a stressful year due to
her mother’s passing. (Id. at 1.) Petitioner’s past medical history included chronic lower
back pain. Musculoskeletal exam documented right leg and hip pain as well as lower
back pain and the review of systems indicated “admits trauma to hip(s), low back and
hip.” Specifically, petitioner reported falling on black ice two weeks prior. (Id. at 1-2.)
Petitioner’s assessment included lower back pain for which she was advised to follow
up with Dr. Allen Troy, an orthopedic surgeon. (Id.) There is no reference to shoulder
pain in this encounter record; however, the record does not confirm any upper extremity
examination.
As discussed separately below, petitioner later consulted Dr. Allen Troy less than
two months later on February 28, 2017, at which time she commenced treatment for her
shoulder condition. (Ex. 2, p. 4.) In the interim, she called her primary care office on
two occasions, on January 5, 2017, and on January 6, 2017. The first call was with
regard to lab work and whether petitioner needed a referral for her anticipated
orthopedic follow up. The second regarded an “excruciating” sinus headache. (Ex. B,
pp. 71, 73.) Neither call mentioned right shoulder pain. Petitioner did not return to her
primary care office until the autumn.
On September 29, 2017, petitioner called Dr. Catherine Troy’s office. The
message was “pt called she wants to talk to you re: a flu shot, and a bad reaction she
got last year.” (Ex. B, p. 67.) The record indicates a recommendation that future
vaccines be administered in the buttock. (Id.) Subsequently, on November 15, 2017,
she returned for her next year’s flu vaccination. At that time, she requested that it be
administered in her gluteus because she “had [a] flu vaccine last year in arm which
caused her multiple medical problems with shoulder from which she [is] still
treating . . . .” (Id. at 64.) Dr. Catherine Troy added the fact of petitioner’s post-
vaccination shoulder pain to her musculoskeletal review of systems as of her 2018
annual exam on January 9, 2018. (Id. at 57.)
On June 5, 2020, petitioner had a facetime appointment as a “f/u shoulder injury
from injection.” (Ex. B, p. 12.) During that encounter, petitioner provided a history of
having a SIRVA following her December 31, 2016 flu vaccination. Dr. Troy records that
“She had a [complete physical exam] on 1/3/2017 [office visit] and remember[s] she
[complained of] pain in [the] arm from Flu vaccine . . . . I did see her on [J]anuary 3rd
and told [her] to put ice on it and give the [S]hingrix in the other arm.” (Id.) Under
separate notes heading, Dr. Troy recorded that “[I] clearly remember [patient] bringing
me [the article of] shoulder injury from injections as a good friend of mine and my
[patient] had a similar occurrence and I had [recommended] gluteal flu shot ever since –
[unfortunately] my documentation [was poor, but patient actually] brought me an article
on [the] injury [which] I do [remember] reading. [I will] write a letter to support her.” (Id.)
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ii. Treatment of shoulder condition
Petitioner presented to Dr. Allen Troy on February 28, 2017, approximately two
months following the vaccination at issue. At that time, she did not discuss the lower
back pain raised at her prior January 3 primary care encounter, but instead raised a
new injury of right shoulder pain. (Ex. 2, pp. 4-5.) Dr. Troy recorded that onset was six
weeks prior, which would be approximately mid-January, but also recorded that
petitioner associated the pain to her flu shot. (Id. at 5.) Dr. Troy prescribed
Nabumetone (an NSAID) and offered a physical therapy referral if symptoms did not
improve. (Id.)
Petitioner presented for a physical therapy evaluation about six weeks later on
April 11, 2017. (Ex. 3, p. 48.) At that time, petitioner reported “R shoulder,
progressively worse. Started right after flu shot, New Years Eve.” The date of onset is
listed as “12/31/2016” and the mechanism of injury is listed as “flu shot.” (Id.)
Petitioner continued to treat her shoulder condition throughout the remainder of
2017 and 2018, but the resulting records are largely uninformative regarding the initial
onset of her condition. In July of 2017, petitioner switched to a different physical
therapist. (Ex. 4, p. 17.) At that time, the mechanism of injury was noted to be an
incorrectly administered flu vaccine, but a specific date of onset was not recorded. The
vaccination was noted to have been “several months ago.” (Id.) On November 30,
2017, petitioner underwent another physical therapy evaluation. (Ex. 8, p. 37.) The
history of present illness indicated “R shoulder adhesive cap from Dec 2016, after flu
shot.” (Id.)
Eventually, petitioner underwent arthroscopic surgery on April 11, 2019. (Ex. 14,
pp. 5-6.) By that time, the course of petitioner’s condition was described only broadly as
“prolonged.” (Id. at 5.) However, petitioner would later indicate to her orthopedic
surgeon during a May 16, 2019, follow up visit that she is “concerned that this is due to
her flu shot from last year when the sx initially were there.” (Id. at 10.) Petitioner
continued to seek treatment thereafter, but the remaining records are not helpful in
resolving onset.
b. As reflected in additional evidence
i. Petitioner’s affidavit
According to petitioner’s affidavit dated March 27, 2018, she recalls getting her
flu vaccination on December 31, 2016, while shopping at Stop and Shop. (Ex. 10, p. 1.)
She recalls the store made an announcement reminding people to get their flu shot and
so she decided to go ahead and get hers. She recalls the pharmacist thanking her for
helping him make his end of year quota. (Id.) She indicates that the injection “hurt
more than usual but I didn’t think anything of it.” (Id.) However, by that evening she
commented to her brother that her arm was hurting from the shot. Petitioner indicates
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she continued to feel pain for the next several days, but suggests she has a high
tolerance for pain which caused her to “brush[] it off.” (Id.)
Petitioner avers that she mentioned her shoulder pain to her doctor at her
subsequent annual exam, but indicates that she did so “in an offhanded way” and that
her doctor recommended icing it. (Id.) Petitioner indicates that the shingles vaccine
she received at this encounter was administered in her left arm because she requested
a left-arm administration due to her right shoulder pain. (Id. at 1-2.) In contrast, she
indicates she expressed no shoulder preference when she received her flu vaccine. (Id.
at 1.)
Petitioner indicates that she continued to ice her shoulder for several weeks, not
becoming concerned until about the third or fourth week. She recalls her pain worsened
while she was staying at her timeshare in Florida, and she called the orthopedist when
she returned from that trip. (Id. at 2.)
ii. Additional witness declarations
Petitioner has filed fourteen witness declarations as follows:
• Ann Lepore, a friend of 20 years, recalls petitioner telling her in early January of
2017 that she received her flu shot and that her shoulder was extremely painful.
(Ex. 19.) She recalls that petitioner indicated she reported it to her physician at
her annual exam and the doctor said to ice it. She suggests this was noteworthy
because petitioner rarely complains of being sick or in pain. (Id.)
• Beth Ann Cody, petitioner’s sister, recalls that petitioner complained on New
Year’s Eve that her shoulder still hurt from her flu shot, that it still hurt on New
Year’s Day, and that they had to cancel plans for that long holiday weekend
because of the shoulder pain. (Ex. 20.) Ms. Cody indicates that she lives with
petitioner during the winter months and so she was able to observe petitioner’s
pain in the days and months following the vaccination. (Id.)
• Bridget Kopek, a longstanding acquaintance, recalls having dinner with petitioner
in mid-January 2017. (Ex. 21.) She recalls petitioner experiencing pain when
reaching for an object on the table, prompting a conversation about how
petitioner’s flu vaccine on New Year’s Eve had been causing her pain. (Id.)
• Daniel Doty, a friend, spoke to petitioner on the phone in early January of 2017
and recalls being told petitioner was experiencing persistent pain since her flu
shot. (Ex. 22.)
• Debbie McCarthy, a friend, recalls being told of petitioner’s post-vaccination
shoulder pain when petitioner stopped by her house for a holiday visit in early
January 2017. (Ex. 23.)
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• Jack Woodley, a neighbor since 2010, also recalls being told during a post-
holiday visit in January 2017 that petitioner was experiencing post-vaccination
shoulder pain. (Ex. 24.)
• John Cody, petitioner’s brother, recalls noticing petitioner’s shoulder pain as of
New Year’s Day when he noticed she didn’t seem to be having a good time and
she explained that her arm was hurting. (Ex. 25.)
• John Nishimoto, a cousin by marriage, recalls that during a visit for an
unspecified holiday in early 2017 petitioner told him she was experiencing
shoulder pain that started the day after her flu vaccination. (Ex. 26.)
• Matt O’Sullivan, a colleague at Hibernian Hall, recalls learning of petitioner’s
shoulder pain during a phone call in early January 2017 as well as again during
an in-person meeting about a week later. (Ex. 27.)
• Nanda Scott, a cousin by marriage, recalls a phone call with petitioner that
occurred in February of 2017 after she had already been to the orthopedist. (Ex.
28.) However, petitioner related her shoulder pain to her flu shot occurring in
December of 2016. (Id.)
• Patricia Macki, a neighbor, recalls a conversation occurring in early January of
2017 during which petitioner indicated her arm had been in pain since getting a
flu shot on New Year’s Eve 2016. (Ex. 29.)
• Susan Saracena, a friend, recalls that during a conversation around the time of
her birthday in late January 2017 petitioner explained that shoulder pain following
her flu vaccination had “put a damper” on her New Year’s Day and had been
bothering her ever since. (Ex. 30.)
• Terese Smith, a friend, recalls a post-holiday phone conversation in early
January 2017 and multiple phone conversations later in January of 2017 during
which petitioner discussed her shoulder pain following her flu shot. (Ex. 31.)
• Terie Rixman, an acquaintance from Hull, Massachusetts, recalls being told in
January of 2017 of petitioner’s post vaccination pain. (Ex. 32.)
iii. Dr. Catherine Troy’s letter and interrogatory responses
Petitioner also filed a “to whom it may concern” letter by her primary care
physician, Dr. Catherine Troy, dated June 5, 2020. (Ex. 18.) In the letter, Dr. Troy
represents that she recalls petitioner complaining of shoulder pain following her flu
vaccination during the physical of January 3, 2017. (Id.) Dr. Troy recalls telling
petitioner to ice her arm and also indicates that she administered petitioner’s shingles
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vaccine in the opposite arm. 3 (Id.) Dr. Troy does not specify which shoulder was
discussed during the January 3 encounter, but misstates that petitioner subsequently
underwent surgery on her left shoulder. (Id.) She indicates that she recommended
future vaccines be administered in the buttock. (Id.)
Dr. Troy subsequently responded to respondent’s interrogatories on March 12,
2021. (Ex. A.) Respondent posed four questions. First, Dr. Troy confirmed she is the
author of the June 5, 2020 letter. Second, asked whether the letter was based on
personal recollection, she responded that it was “based on her symptoms and history.”
Third, asked to describe in detail the information she reviewed when writing the letter,
she indicated she reviewed a note from January 9, 2018, the immunization log showing
her recommendation for future vaccines to be administered in the buttock, and a pre-op
note from March 28, 2019. (All of these documents were attached to the interrogatory
response.) Fourth, asked to confirm under penalty of perjury that the letter was written
solely by her and reflects her independent recollection, Dr. Troy responded “yes.” (Id.)
IV. Party Positions
In her motion, petitioner contends that she suffered a right-side shoulder injury
meeting all four elements demonstrating a SIRVA Table injury and is therefore entitled
to compensation. (ECF No. 78, p. 8.) Given the posture of the case, petitioner’s brief
focuses on the second element, i.e., whether her shoulder pain began within 48 hours
of vaccination. (Id. at 9.) Respondent disputes that petitioner has offered preponderant
evidence that her shoulder pain began during that timeframe. Accordingly, respondent
suggests petitioner has not demonstrated a Table SIRVA and her claim should be
dismissed. (ECF No. 80, p. 7.) Respondent does not raise any argument as to any
other aspect of petitioner’s Table SIRVA claim or assert that a factor unrelated to
vaccination caused petitioner’s condition.
Addressing the fact that petitioner’s January 3, 2017 encounter record with Dr.
Catherine Troy does not reflect that she discussed her shoulder pain with Dr. Troy at
that time, petitioner stresses two points. First, other evidence of record indicates
otherwise. (ECF No. 78, p. 9.) Second, the Federal Circuit has rejected the notion that
there is a presumption that medical records are complete as to all of a patient’s
conditions. (Id. (citing Kirby v. Sec’y of Health & Human Servs., 997 F.3d 1378, 1383
(Fed. Cir. 2021)).) Petitioner notes that it is not unusual for SIRVA petitioners to delay
treatment thinking that their symptoms will be transitory. (Id. at 10 (quoting Wyffels v.
Sec’y of Health & Human Servs., No. 18-1874V, 2021 WL 798834 (Fed. Cl. Spec. Mstr.
Jan. 26, 2021)).)
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Specifically, the letter states: “I did see her on January 3rd, advised her to put ice on [the] shoulder and
also gave her a Shingrix Vaccine in the other arm.” (Ex. 18.) It is not clear whether Dr. Troy meant to
suggest that she herself had administered this vaccine; however, both the medical record and petitioner’s
affidavit confirm that the vaccine was administered by a nurse. (Ex. 5, p. 2; Ex. 10, p. 1.)
9
Petitioner further explains that the Vaccine Act explicitly permits a special master
to find that a first symptom or manifestation of a Table injury began within the
prescribed period “even though the occurrence of such symptom or manifestation was
not recorded or was incorrectly recorded as having occurred outside such period.” (Id.
at 11 (quoting 42 U.S.C. § 300aa-13(b)(2)).) In that regard, petitioner stresses that her
subsequent medical records are consistent in placing onset of her condition in the
context of her December 31, 2016 flu vaccination. (Id.) She also points to the
additional letter by Dr. Catherine Troy as well as her fourteen supporting witness
declarations. (Id. at 11-12.)
Petitioner argues that Dr. Allen Troy’s reference to onset occurring six weeks
prior to February 28, 2017 is “nebulous” and uncorroborated by any other evidence of
record. (Id. at 12.) Petitioner also emphasizes that the same notation associated onset
with petitioner’s flu shot. (Id. (quoting Ex. 2, p. 5).)
In contrast, respondent stresses that petitioner’s first post-vaccination primary
care encounter of January 3, 2017, and her first treatment for her shoulder condition on
February 28, 2017, are both consistent in failing to place onset of petitioner’s condition
within 48 hours of her vaccination. That is, petitioner failed to report any shoulder
symptoms on January 3, three days post-vaccination, then reported an onset falling in
mid-January of 2017 when she later reported for orthopedic care. (ECF No. 80, p. 4
(discussing Ex. 3, pp. 112-13 and Ex. 2, pp. 4-6).) Respondent also notes that the
January 3, 2017 record contains no objective findings that could confirm the presence of
shoulder pain at that time. (Id. at 6.) Respondent notes that contemporaneous medical
records generally warrant consideration as trustworthy evidence. (Id. at 1 (quoting
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993)).)
Therefore, respondent contends that these initial treatment records should be given
significant weight. (Id. at 5.)
Respondent urges that Dr. Catherine Troy’s subsequent letter should be given
little weight. (Id. at 5.) In particular, respondent notes that her subsequent letter was
written three years after the fact, misidentifies the shoulder at issue, and was informed
by much later records dating from 2019. (Id.) Respondent therefore argues her
recollection should be rejected as not reflecting an independent recollection of events.
(Id. at 6.) Respondent also contends that petitioner’s witness declarations should also
be given less weight, because they are recollections presented years later and by
individuals who are not necessarily disinterested. (Id. at 6-7 (quoting Reusser v. Sec’y
of Health & Human Servs., 28 Fed. Cl. 516, 523 (1993) and Lett v. Sec’y of Health &
Human Servs., 39 Fed. Cl. 259, 260 (1997)).)
V. Discussion
As explained above, the Vaccine Injury Table lists SIRVA as a compensable
injury if it occurs within 48 hours of administration of a vaccine containing the influenza
virus. § 300aa-14(a) as amended by 42 C.F.R. § 100.3(a). To be considered a Table
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“SIRVA,” petitioner must show: (i) there is “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) that “onset of pain occurred within the
specified timeframe,” i.e. within 48 hours; (iii) that “pain and reduced range of motion
are limited to the shoulder in which the intramuscular vaccine was administered”; and
(iv) that “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(a); 42 C.F.R.
§ 100.3(c)(10).
In this case, only the question of onset is disputed. Moreover, my own review of
the record confirms that the other SIRVA QAI criteria are preponderantly satisfied.
Accordingly, if there is preponderant evidence that petitioner’s shoulder pain began
within 48 hours of vaccination, then she is entitled to compensation for a Table SIRVA.
For the reasons discussed below, I conclude when considering the record as a whole
that petitioner’s shoulder pain did more likely than not begin within 48 hours of
vaccination and petitioner is entitled to compensation.
The process for making determinations in Vaccine Program cases regarding
factual issues begins with consideration of the medical records. § 11(c)(2). The special
master is required to consider “all [ ] relevant medical and scientific evidence contained
in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or
coroner’s report which is contained in the record regarding the nature, causation, and
aggravation of the petitioner's illness, disability, injury, condition, or death,” as well as
“the results of any diagnostic or evaluative test which are contained in the record and
the summaries and conclusions.” § 13(b)(1)(A). The special master is then required to
weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir.
1993). Pursuant to Vaccine Act § 13(a)(1)(A), a petitioner must prove their claim by a
preponderance of the evidence. A special master must consider the record as a whole,
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. § 13(b)(1). As petitioner observes in her motion, a
special master may find that onset of a Table injury occurred within the specified
timeframe “even though the occurrence of such symptom or manifestation was not
recorded or was incorrectly recorded as having occurred outside such period” so long
as the finding is preponderantly supported. 42 U.S.C. § 300aa-13(b)(2)).
Here, when considering petitioner’s actual treatment records as a whole, they
preponderate in favor of an immediate post-vaccination onset. Respondent is correct
that Dr. Allen Troy’s initial encounter record includes a notation that would place onset
in mid-January if given precedence; however, petitioner is also correct to note that the
same record specifically associates the injury to vaccination. When petitioner
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subsequently presented for her first physical therapy evaluation on April 11, 2017, the
record much more clearly places onset by indicating “Started right after flu shot, New
Years Eve.” The date of onset is further specified as “12/31/2016” and the mechanism
of injury is listed as “flu shot.” (Ex. 3, p. 48.) Respondent limits his discussion of this
record to a footnote and asserts incredibly that it lacks specificity. (ECF No. 80, p. 3
n.2.) Several subsequent records by different providers further repeat the same basic
history with varying detail. (Ex. 4, p. 17; Ex. 8, p. 37; Ex. 14, p. 10.) Given the
specificity of the April 11, 2017, physical therapy evaluation, the other less specific
notations can easily be read as being in harmony, including that aspect of Dr. Allen
Troy’s notation that associates the shoulder pain to the vaccination, albeit while
otherwise incongruently identifying the duration of the injury.
This conclusion is further bolstered by petitioner’s affidavit and numerous fact
witness declarations. While the fact witness declarations do not merit the same weight
as the contemporaneous medical records, they are entitled to some weight and are both
numerous and remarkably consistent as far as they go in terms of detail. Moreover,
they are consistent with the medical records when the medical records are considered
as a whole. All but a few of the statements confirm the presence of ongoing shoulder
pain based on interactions with petitioner occurring in January of 2017. Several also
include added detail associating petitioner’s pain to a vaccination received on New
Year’s Eve.
Respondent is correct to note that petitioner’s January 3, 2017 encounter record
does not reflect any complaint of shoulder pain just three days post-vaccination.
Importantly, however, this record is merely silent as to the existence of any pain rather
than directly negating the presence of any shoulder pain. “[T]he absence of a reference
to a condition or circumstance is much less significant than a reference which negates
the existence of the condition or circumstance.” Murphy v. Sec’y of Health & Human
Servs., 23 Cl. Ct. 726, 733 (1991) (quoting the decision below), aff’d per curiam, 968
F.2d 1226 (Fed. Cir. 1992). Here, the record reflects that petitioner was experiencing
back and hip pain caused by a recent fall. (Ex. 5, p. 2.) Unsurprisingly then, a
musculoskeletal exam demonstrated symptoms relative to the lower back, hip, and legs;
however, it does not confirm that any upper extremity exam was completed. Accord
Kirby, 997 F.3d at 1384 (rejecting any presumption that medical records are complete
and further rejecting the government’s contention that notation of a partial neurologic
exam is evidence that no other reproducible symptoms were present). Although
petitioner suggests that she did report shoulder pain at this visit, she admits that it was
only presented in an “offhanded” manner as she had not yet concluded that her pain
would not go away. (Ex. 10, p. 1.) As petitioner notes in her motion, this type of
thinking is not necessarily unusual among SIRVA patients. See, e.g., Lang v. Sec’y of
Health & Human Servs., No. 17-995V, 2020 WL 7873272, at *11 (Fed. Cl. Spec. Mstr.
Dec. 11, 2020) (noting that “there is no such thing as an ‘appropriate’ time to seek
treatment”); Smallwood v. Sec’y of Health & Human Servs., No. 18-291V, 2020 WL
2954958, at *10 (noting that is it “common for a SIRVA petitioner to delay[] treatment,
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thinking his/her injury will resolve on its own”). In that regard it is significant that this
encounter was, in fact, very soon after the vaccination at issue.
Considering all of the circumstances and other evidence of record, the fact that
the January 3, 2017 encounter record is silent is not strong evidence that shoulder pain
was absent. Thus, even without considering Dr. Troy’s subsequent statements, it does
not outweigh the collective weight due the contemporaneous treatment records and, to
a lesser extent, the witness statements, all of which are otherwise in accord. For this
reason, I do not find it necessary to determine whether Dr. Troy’s subsequently
furnished letter is reliable.
VI. Conclusion
For all the reasons discussed above, after weighing the evidence of record as a
whole, I find by preponderant evidence that petitioner suffered a Table Injury of SIRVA
following her December 31, 2016 influenza vaccination as alleged. She is therefore
entitled to compensation. Because I have found the presence of a Table Injury in this
case, it is not necessary to address whether petitioner has presented a cause-in-fact
claim. A separate damages order will be issued.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
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