Tinley v. Secretary of Health and Human Services ( 2019 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-0413V
Filed: January 31, 2019
UNPUBLISHED
TERESA TINLEY,
Special Processing Unit (SPU);
Petitioner, Ruling on Entitlement; Decision After
v. Fact Hearing and Fact Ruling; Onset;
Table Injury; Influenza (Flu) Vaccine;
SECRETARY OF HEALTH Shoulder Injury Related to Vaccine
AND HUMAN SERVICES, Administration (SIRVA)
Respondent.
Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for petitioner.
Sarah Christina Duncan, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT 1
Dorsey, Chief Special Master:
On March 23, 2017, Teresa Tinley (“petitioner”) 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 left shoulder injuries
caused by an October 30, 2015 influenza (“flu”) vaccination. Petition at 1-2. The case
was assigned to the Special Processing Unit of the Office of Special Masters. For the
reasons discussed below, the undersigned finds that petitioner is entitled to
compensation.
1 The undersigned intends to post this ruling on the United States Court of Federal Claims' website. 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, upon review, the undersigned
agrees that the identified material fits within this definition, the undersigned will redact such material from
public access. Because this unpublished ruling contains a reasoned explanation for the action in this
case, undersigned is 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).
2National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C.
§ 300aa (2012).
I. Procedural History
a. From Petition Filing to Fact Hearing
On March 23, 2017, Ms. Tinley filed her petition (ECF No. 1). On March 28,
2017, she filed medical records marked as Exhibits 1-8 (ECF Nos. 6 and 7). She also
filed a Statement of Completion on March 28, 2017 (ECF No. 9). The initial status
conference was held on May 2, 2017 (ECF No. 11). Additional medical records were
filed as Exhibit 9 on June 7, 2017 (ECF No. 12).
On October 3, 2017, respondent filed a status report requesting additional
medical records (ECF No. 18). On November 15, 2017, petitioner filed additional
medical records as Exhibits 10 and 11 (ECF No. 21). On December 15, 2017,
respondent submitted a status report requesting 45 days to file a Rule 4(c) Report (ECF
No. 25). This request was granted.
On January 29, 2018, respondent filed his Rule 4(c) Report (ECF No. 30).
Respondent argued that the medical records “fail[ed] to establish by preponderant
evidence that the vaccine administration caused petitioner to suffer SIRVA. Petitioner
did not complain of shoulder pain to a medical provider until March 22, 2016,
approximately five months after vaccination . . . She did not receive any evaluation or
treatment of her alleged arm pain until a few weeks later, on April 6, 2016. Therefore, it
is not clear that petitioner’s pain began within forty-eight hours of vaccination.”
Respondent’s Rule 4(c) Report at 3-4 (ECF No. 30).
Thereafter, following a status conference held by the staff attorney managing this
case, the undersigned requested that petitioner inform the court how she wished to
proceed in this case (ECF No. 31). On March 16, 2018, petitioner filed a status report
indicating that she wished to proceed with a hearing (ECF No. 32). A fact hearing was
scheduled, and petitioner was afforded the opportunity to file additional evidence in the
form of an affidavit from her sister (ECF Nos. 33, 34, 36). Petitioner later reported that
she would not be submitting an affidavit from her sister. Petitioner’s Status Report, filed
May 22, 2018 (ECF No. 38).
b. Fact Hearing and Ruling
A fact hearing was held in Washington, D.C., on July 17, 2018. Ms. Tinley was
the sole witness and she appeared via video-conference from Pennsylvania with her
attorney. At the conclusion of the hearing, the undersigned informed the parties that
she intended to issue a ruling from the bench. The undersigned then issued a bench
ruling finding that the onset of petitioner’s symptoms occurred within 48 hours of
vaccination.
On September 5, 2018, the undersigned issued a written fact ruling
memorializing the bench ruling. Fact Ruling, issued Sept. 5, 2018 (ECF No. 46). In the
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fact ruling, the undersigned found that the onset of petitioner’s left shoulder injuries
occurred within 48 hours of her October 30, 2015 influenza vaccination.
On August 31, 2018, the undersigned issued a scheduling order directing the
parties to file any additional evidence they wished to have considered concerning
entitlement by October 5, 2018. The parties were informed that after that date, the
record concerning entitlement would close and a ruling on entitlement would issue.
II. Factual History
Ms. Tinley was 65 years old when she received the flu vaccine in her left arm at a
Rite Aid pharmacy on October 30, 2015. Petitioner’s Exhibit (“Pet. Ex.”) 1 at 1-2. She
was in good health and had no prior history of pain or injury in either shoulder. See Tr.
at 6-7; see generally Pet. Ex. 7 at ¶¶ 1, 9-10, 15-16. Petitioner averred in her affidavit
that the injection “immediately hurt,” and that the pharmacist told her it would be sore for
a couple of days. Id. at ¶ 4. Petitioner averred that the pain worsened in November
2015 and by January 2016 the range of motion in her left shoulder had declined. Id. at
¶¶ 6-7. During this time, she used ice packs throughout the day. Id. She averred that
in February 2016, she was still in pain and realized it was not going to go away on its
own. Id. at ¶ 8.
On March 22, 2016, petitioner returned to Rite Aid to seek advice. Id. at ¶ 9. A
Vaccine Adverse Event Reporting System (“VAERS”) report was filed in petitioner’s
name by Tim Lisberg of Rite Aid. Pet. Ex. 6. The VAERS report stated that petitioner
had “pain in upper arm, ‘debilitating’ according to patient. Pain still present as of
3/22/16, when vaccine given 10/30/15.” Id. at 1. The VAERS report listed the date of
vaccination as 10/30/15 and the date of adverse event onset as 10/31/15. Id. Petitioner
testified that the report was filed by Rite Aid after she returned there in March 2016
reporting her symptoms. Tr. at 19. She testified that initially she went to Rite Aid rather
than a doctor “[t]o ask for advice. I thought this is where it started, maybe they can
direct me, maybe they can tell me what I need to do or tell me if this has happened
before to others . . . just to get advice.” Id. Petitioner testified that at Rite Aid she was
told her a VAERS report would be filed and she was informed of the Vaccine Program.
On April 6, 2016, petitioner reported to orthopedist Jane Tan, M.D. Pet. Ex. 3 at
1. Petitioner reported that she had a flu shot in October 2015 and afterward had
swelling and redness. Id. She reported that since then she had difficulty with overhead
reaching and dropping objects. Id. On examination, she exhibited positive Neer’s and
Hawkins impingement signs and tenderness over the bicipital groove. Id. Her left arm
demonstrated reduced external rotation of 45°, compared to 60° on her uninjured right
side. Id. X-rays were taken and found to be normal. Id. Dr. Tan diagnosed petitioner
with left rotator cuff syndrome and left biceps tendinitis and administered a cortisone
injection to the left subacromial space. Id. at 1-2. Dr. Tan provided petitioner with a
physical therapy prescription for use as needed. Id. at 2.
3
On May 25, 2016, petitioner was seen by nurse practitioner (“NP”) Karen
Richard-Reynolds at Eagles Landing Family Practice. Petitioner reported that she
received a flu shot at Rite Aid in October 2015 and had “severe and constant” pain in
her left arm. Pet. Ex. 2 at 1. NP Richard-Reynolds diagnosed petitioner with left upper
arm pain and provided her with a physical therapy referral. Id. at 2.
On June 1, 2016, petitioner reported to physical therapist Stevi Wheeler of
Benchmark Physical Therapy for an initial evaluation. Pet. Ex. 4 at 15. Petitioner
reported that she received a flu shot in her left arm and felt something rip in her arm. Id.
Petitioner reported that she had been “very inhibited” for several months, and had ‘dealt
with it’ for several months until April when she went to see an orthopedist and received
a steroid injection with no changes. Id. Petitioner reported moderate to severe loss of
function, severe stiffness, pain, and weakness, and moderate to severe problems with
driving. Id. On examination, physical therapist Wheeler found that petitioner’s active
range of motion was limited to 85° in flexion and 70° in abduction and stated a goal of
180° for both. Id. at 16. 3
On June 2, 2016, petitioner reported to physical therapist Wheeler for a second
physical therapy session. Id. at 13. Petitioner reported a pain level of 5/10 and that her
arm was better but remained sore when trying to sleep. Id. On June 6, 2016, petitioner
returned for another physical therapy session. She reported a pain level of 5/10 and
reported that her pain was better and she had not had an episode of pain reaching
10/10 recently. Id. On June 8, 2016, petitioner attended a fourth physical therapy
session. Id. at 7. She reported a pain level of 5 out of 10 and that she was slowly
getting better. Id. On June 30, 2016, after four sessions, petitioner was discharged
from physical therapy at her request for financial reasons. Pet. Ex. 4 at 4-6.
On June 9, 2016, petitioner was seen by physician assistant (“PA”) Miranda
Stone at Eagles Landing Family Practice. Pet. Ex. 2 at 4. Petitioner reported pain in
her left arm for the past eight months following a flu vaccination on 10/30/15. Id.
Petitioner reported that she believed she was injected in a nerve and had experienced
sharp and stabbing pain with constant throbbing. Id. Petitioner reported that she had
started physical therapy but that the pain had not resolved. Id. PA Stone diagnosed
petitioner with left shoulder strain, directed petitioner to stop physical therapy for two
weeks, and referred her for an orthopedic consultation.
Ms. Tinley filed an affidavit dated February 8, 2017 in which she averred that
prior to the October 30, 2015 vaccination, she was in “good health,” walked three miles
a day, did water aerobics. Pet. Ex. 7 at ¶ 1. She averred that the flu vaccine
administered on October 30, 2015 “immediately hurt.” Id. at ¶ 4. She stated that the
3 The record states, “Right AROM [Active Range of Motion].” Pet. Ex. 4 at 16. However, the reference to
the right shoulder appears to be a typo. The rest of physical therapist Wheeler’s initial evaluation record
indicates that the evaluation concerned petitioner’s left shoulder. See, e.g., “TTP [tender to palpation]
along L upper arm,” Pet. Ex. 4 at 16, “Patient presents with signs and symptoms that are consistent with:
L arm pain,” Id. at 17, diagnosis of “M79.622 Pain in left arm, M 25.512 Pain in left shoulder.” Id. at 15.
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morning after the vaccine administration, the injection site “was puffy and more red than
the previous day. The area was very sore to the touch.” Id. at ¶ 5. She averred that in
November 2015, “the pain in my left arm at the injection site increased to a throbbing
pain . . . . It became difficult to sleep . . . Due to the pain that accompanied trying to find
a comfortable position to sleep, I was up and down throughout the night.” Id. at ¶ 6. By
January 2016, she averred, “the range of motion of my left arm declined. If I moved my
arm towards my backside or tried to raise it over my head to put on clothes, I had
excruciating pain. It was as if a knife were stabbing into my flesh.” Id. at ¶ 7.
Petitioner further averred that since her flu vaccination, “I am unable to use my
left arm to dress myself. I cannot use my left arm to help wash my back or lift it high
enough to wash my hair . . . . Simply opening or closing my car door, or latching a
seatbelt with my left arm leads to severe pain. As a whole, I have had to adjust my daily
routine in order to avoid the excruciating pain . . . . My entire life changed after the flu
vaccine.” Id. at ¶¶ 15-16.
At the hearing, petitioner testified about her pre-vaccination health status. She
testified that before the vaccination she never had problems with either shoulder.
Transcript (“Tr.”), Fact Hearing (July 17, 2018), at 7. She further testified that prior to
her vaccination:
I was a very healthy person. I never had any injuries, [took] no medications, very
self-sufficient, very independent woman. I cut grass, four acres of grass every
weekend, cut tree limbs down, cleaned my house, did interior decorating for
people, previously had worked in the construction industry . . . did water
aerobics, exercising, walking two, three miles a day, sometimes twice a day, just
very active.
Tr. at 6-7.
Petitioner testified that she “experienced pain immediately [after vaccination] . . . .
it’s still sore right here.” Tr. at 12. She testified that at the time of vaccination she had
“no insurance other than Medicare” and her sole sources of income were Social
Security and income from a seasonal job where she formerly worked for approximately
three to five months per year. Id. at 15-16. She explained that she considered going to
the emergency room due to her shoulder pain but “[o]nly having Medicare, I knew that I
would have to pay at least 20 percent copay and it was the money factor.” Id. at 20.
For this reason, she opted to see an orthopedic specialist rather than going to the
emergency room. Id.
She testified that the “cortisone shot [administered by orthopedist Dr. Tan] really
didn’t do anything that I could tell.” Id. at 22. She explained that after four physical
therapy sessions and two primary care visits, she had ceased seeking formal treatment
for her shoulder because “[n]o one seemed to understand about the pain . . . . [a]nd
they wanted to mask it with pain pills . . . I did not want to take pain pills. I was wanting
to know what was wrong and what we could do to make it better, and they could not
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give me that answer.” Id. at 23. She explained that physical therapy had helped some,
but she stopped going because she ran out of money for copays and felt the last visit
may have reinjured her shoulder. Id.
Ms. Tinley filed an affidavit dated August 16, 2016 averring that “no civil actions
have been filed, nor have I received or collected an award or settlement of a civil action
for damages for this vaccine related injury. Furthermore, I am not aware of anyone who
has received or collected an award or settlement of a civil action for damages for this
vaccine related injury.” Pet. Ex. 8 at 1.
III. Respondent’s Rule 4(c) Report
On January 29, 2018, respondent filed his Rule 4(c) Report (ECF No. 30).
Respondent argued that the medical records “fail[ed] to establish by preponderant
evidence that the vaccine administration caused petitioner to suffer SIRVA. Petitioner
did not complain of shoulder pain to a medical provider until March 22, 2016,
approximately five months after vaccination . . . She did not receive any evaluation or
treatment of her alleged arm pain until a few weeks later, on April 6, 2016. Therefore, it
is not clear that petitioner’s pain began within forty-eight hours of vaccination.”
Respondent’s Rule 4(c) Report at 3-4 (ECF No. 30).
In the Rule 4(c) Report, respondent further asserted that a special master
“cannot find that a vaccine-related injury occurred based solely upon the claims of
petitioner (see 42 U.S.C. § 300aa-13(a)(1)); it must be substantiated by petitioner’s
medical records, or by a credible expert medical opinion.” Id. at 4. Respondent argued
that in this case “the physicians who evaluated petitioner for her shoulder pain noted the
reported temporal association between the flu shot and the shoulder pain, but no
physician opined that petitioner’s October 30, 2015, flu vaccination was the cause of her
alleged injury.” Id.
IV. Legal Standard
Pursuant to Vaccine Act § 13(a), compensation shall be awarded if a special
master finds on the record as a whole that the petitioner has “demonstrated by a
preponderance of the evidence the matters required in the petition” by Vaccine Act
§ 11(c)(1). A petitioner can assert a Vaccine Injury Table (“Table”) petition under
Vaccine Act § 11(c)(1) by filing an affidavit and supporting documentation
demonstrating, inter alia, that the person who suffered an injury or died:
1. Received a vaccine set forth in the Table (Vaccine Act §11(c)(1)(A));
2. Received the vaccine in the United States (Vaccine Act §11(c)(1)(B));
3. Sustained, or had significantly aggravated any illness, disability, injury, or
condition set forth in the Table, and the first symptom or manifestation of
the onset or significant aggravation “occurred within the time period after
vaccine administration set forth in the Vaccine Injury Table” (Vaccine Act
§11(c)(1)(C));
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4. Suffered the residual effects or complications of the injury for more than
six months after the administration of the vaccine (Vaccine Act
§11(c)(1)(D)); and
5. Has not previously collected an award or settlement of a civil action for
damages for such vaccine-related injury or death (Vaccine Act
§11(c)(1)(E)).
In this case, the undersigned finds that petitioner has demonstrated by a
preponderance of the evidence the matters required in the petition pursuant to §11(c)(1)
of the Vaccine Act as listed above. Therefore, petitioner is entitled to compensation.
a. Petitioner received a vaccine set forth in the Table
Petitioner has demonstrated that on October 30, 2015, she received an influenza
vaccination, which is a vaccine set forth in the Table. Therefore, this requirement is
met.
b. Petitioner received the vaccine in the United States
The preponderance of the evidence demonstrates that petitioner received her flu
vaccination at a Rite Aid in Covington, Georgia, which is in the United States.
c. Petitioner sustained an injury set forth in the Table, and the first
symptom or manifestation of the onset occurred within the time
set forth in the Table
Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed
on the Vaccine Injury Table (“Table”). See Vaccine Injury Table: Qualifications and Aids
to interpretation. 42 C.F.R. § 100.3(c)(10). The undersigned determines that petitioner
has demonstrated that her injury meets the SIRVA Table requirements, as informed by
the Qualifications and Aids to Interpretation for SIRVA criteria. The criteria are as
follows:
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).
Id.; see also National Vaccine Injury Compensation Program: Revisions to the
Vaccine Injury Table, 80 Fed. Reg. 45132, Notice of Proposed Rulemaking, July
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29, 2015 (citing Atanasoff S, Ryan T, Lightfoot R, and Johann-Liang R, 2010,
Shoulder injury related to vaccine administration (SIRVA), Vaccine 28(51):8049-
8052).
i. This case was filed on or after March 21, 2017, the date the
Table changes listing SIRVA took effect
The petition in this case was filed on March 23, 2017. The Table changes listing
SIRVA as a Table injury took effect on March 21, 2017. Therefore, the Table changes
apply to this petition and petitioner’s claim may be analyzed as a Table SIRVA case. In
addition, as explained further below, the undersigned finds that petitioner has
demonstrated that her injury meets the Table SIRVA criteria.
ii. Petitioner had no history of pain, inflammation or
dysfunction of her left shoulder prior to vaccine
administration that would explain her signs, symptoms,
and examination findings after vaccine injection
Respondent has not contested that petitioner meets this criterion, and the
undersigned finds that she has demonstrated a lack of history of pain, inflammation, or
dysfunction of her left shoulder that would explain her symptoms. Prior to vaccine
administration, petitioner was a healthy, active adult. She rarely had the need to see a
doctor and performed regular exercise and home and yard maintenance work.
Therefore, petitioner has demonstrated by a preponderance of the evidence that she
had no history of left shoulder injuries that would explain her post-vaccination
symptoms.
iii. Petitioner’s injury occurred within 48 hours, which is the
specified time frame
Pursuant to Vaccine Act § 13(b)(2), a special master may find that the first
symptom or manifestation of onset occurred within the time period set forth in the Table
even if the occurrence of such symptom or manifestation was not recorded or was
incorrectly recorded as having occurred outside such period. In the September 5, 2018
fact ruling, the undersigned determined that the onset of petitioner’s left shoulder
injuries occurred within 48 hours of her October 30, 2015 influenza vaccination based
on medical records and petitioner’s testimony and affidavit. Fact Ruling, issued Sept. 5,
2018 (ECF No. 46). Thus, petitioner has demonstrated by a preponderance of the
evidence that her injury occurred within the time specified in the Table for a SIRVA.
iv. Petitioner’s pain and reduced range of motion are limited to
the shoulder in which the intramuscular vaccine was
administered
Respondent has not contested that petitioner meets this criterion. Petitioner
testified that her symptoms occurred in her left shoulder. The undersigned finds that
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she has demonstrated that her pain and reduced range of motion were limited to the
shoulder in which the intramuscular vaccine was administered.
v. No other condition or abnormality is present that would
explain petitioner’s symptoms
Respondent has not contested that petitioner meets this criterion, and the
undersigned finds that the preponderance of the evidence supports a conclusion that
there is no other condition or abnormality present that would explain petitioner’s
condition.
vi. Conclusion concerning Table SIRVA criteria
The undersigned concludes that petitioner has demonstrated that she meets all
requirements to demonstrate entitlement to compensation for a SIRVA as included on
the Table.
d. Petitioner suffered the residual effects or complications of the
injury for more than six months
Petitioner continued physical therapy and medical evaluation until June 2016,
approximately eight months following her vaccination. Thus, she has satisfied the
requirement that she demonstrate that she suffered the residual effects of her injury for
more than six months.
e. Petitioner has not previously collected an award or settlement of
a civil action for damages
Petitioner filed an affidavit averring that she has not previously collected an
award or settlement of a civil action for damages. Thus, this requirement is satisfied.
f. Respondent’s other contentions
In his Rule 4(c) Report, respondent contends that pursuant to Vaccine Act
§ 13(a)(1), a special master cannot find a vaccine-related injury occurred based solely
upon the claims of petitioner. Respondent’s Rule 4(c) Report at 4. Respondent further
argues that petitioner’s physicians did not opine that her vaccination was the cause of
her injury. The undersigned finds these arguments unavailing.
Section 13(a)(1) states that a special master cannot find a vaccine-related injury
“based on the claims of a petitioner alone, unsubstantiated by medical records or
medical opinion” (emphasis added). Therefore, such a finding cannot be made solely
based on the claims of a petitioner, but it may be made based on a petitioner’s claims if
such claims are supported by medical records and/or opinion.
In this case, the undersigned finds that petitioner’s claims are supported by
medical records. Specifically, when petitioner reported to orthopedist Dr. Tan on April 6,
2016, she reported that the date of injury was October 30, 2015 (the date of
vaccination), and that she had pain immediately which progressively worsened. When
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petitioner reported to nurse practitioner Reynolds on May 25, 2016, she reported that
when the flu shot was given it felt like something tore in her arm. In addition, physician
assistant Stone noted on June 9, 2016 that petitioner received the flu vaccine on
October 30, 2015 and her arm had been painful since that time. The physical therapy
initial evaluation and subsequent physical therapy records document the date of onset
of petitioner’s injury as October 30, 2015. Finally, the VAERS report dated March 22,
2016 documents an onset date of October 31, 2015.
These medical records support and substantiate petitioner’s detailed testimony
and affidavit describing the onset of her symptoms. Taken together, the medical
records, hearing testimony, and affidavits demonstrate that petitioner experienced pain
immediately following vaccination and attempted to self-treat with ice packs for several
months. She considered seeing a doctor but delayed doing so because she was
uncertain what kind of doctor she should see and hoped that the pain would go away on
its own. The fact that her first attempt to take steps beyond self-treatment involved
returning to the pharmacy where she received the vaccine bolsters her explanation that
she did not know what kind of doctor to see or where to seek help. The undersigned
found petitioner to be a credible witness and finds her testimony and affidavit to be
consistent with the medical records. Thus, the undersigned’s finding that the
preponderance of the evidence demonstrates that the onset of petitioner’s injury
occurred within 48 hours of vaccination is consistent with § 13(a)(1).
Furthermore, respondent’s suggestion that petitioner must produce a medical
opinion demonstrating a link between her vaccination and injury is not applicable in the
context of this case. Because this case meets the requirements of a Table injury,
causation is presumed and petitioner need not provide a medical opinion to establish
causation. Therefore, the undersigned determines that respondent’s objections are
without merit.
V. Conclusion
In light of all of the above, and in view of the submitted evidence, including
the medical records, affidavits, credible witness testimony, and fact ruling, the
undersigned finds that petitioner is entitled to compensation under the Vaccine
Act.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
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