The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-0225V
Filed: November 9, 2018
Unpublished
****************************
ELIZABETH SCHANDEL, *
*
Petitioner, * Finding of Fact; Influenza (“Flu”)
v. * Vaccine; Shoulder Injury Related to
* Vaccine Administration (“SIRVA”);
SECRETARY OF HEALTH * Proof of Vaccination; Onset; Lack of
AND HUMAN SERVICES, * Prior Condition; Clinical Course for
* SIRVA; Special Processing Unit (“SPU”)
Respondent. *
*
****************************
Bruce William Slane, Law Office of Bruce W. Slane, P.C., White Plains, NY, for
petitioner.
Amy Paula Kokot, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON FACTS1 AND SCHEDULING ORDER– SPECIAL PROCESSING UNIT
Dorsey, Chief Special Master:
On February 16, 2016, Elizabeth Schandel (“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” or “Program”) “for injuries, including a torn
rotator cuff in her right shoulder, resulting from adverse effects of a trivalent influenza
vaccination received on October 20, 2011.” Petition at 1 (ECF No. 1). Petitioner filed
amended petitions on March 20 and June 20, 2018, asserting that she suffered a
shoulder injury related to vaccine administration (“SIRVA”), which included a
1The 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 Because this unpublished ruling contains a reasoned explanation for the action in this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).
strain/sprain, tendinopathy, and tear of her right rotator cuff, bursitis, and adhesive
capsulitis, caused-in-fact by the influenza vaccination she received on October 20,
2011. (ECF Nos. 52, 57). The case was assigned to the Special Processing Unit
(“SPU”).
On October 1, 2018, respondent filed a motion for a factual ruling, requesting that
the undersigned make formal rulings regarding the informal factual rulings she made in
April 2018. (ECF No. 65). The same day, petitioner filed a status report indicating he
did not anticipate opposing respondent’s request. (ECF No. 66).
Based on the record as a whole and for the reasons set forth below, the
undersigned finds by preponderant evidence that (1) the record of vaccination is
sufficient to establish petitioner received, intramuscularly, the vaccination alleged as
causal; (2) there is sufficient other evidence to establish the vaccination was
administered in petitioner’s right arm; (3) the onset of petitioner’s pain occurred within
48 hours, specifically on the day of vaccination; (4) petitioner had no prior problem with
her right shoulder/upper arm; and (4) the clinical course of petitioner’s injury mirrored
what is seen typically in a SIRVA.
I. Procedural History
Prior to the original petition in this case, in 2014, petitioner filed a petition seeking
compensation for her right shoulder injury, alleged as vaccine caused.3 When petitioner
failed to provide evidence regarding the date of dismissal of her prior civil action, this
earlier case was dismissed without prejudice. See Schandel v. Sec’y of Health &
Human Servs., No. 14-1010V, 2015 WL 2260424 (Fed. Cl. Spec. Mstr. Apr. 21, 2015).
Petitioner filed the original petition in this case on February 16, 2016. (ECF No.
1). On February 29, 2016, she filed documentation showing petitioner’s civil claim was
dismissed on August 4, 2014. (ECF No. 8-3). Along with the documentation regarding
petitioner’s earlier civil action, petitioner filed medical records from two orthopedic visits
on November 7 and 14, 2011, the results of an MRI performed on November 12, 2011,
and medical and billing records from physical therapy (“PT”) attended in October 2011
through February 2012. (ECF No. 8-4). The same day, she filed these records a
second time, this time without the civil case documentation. (ECF No. 9-1). In both
instances, these partial medical records were filed as one exhibit without proper
labeling.
Over the subsequent year, petitioner attempted to file the required affidavit and
medical records. See § 11(c) (petition requirements); Vaccine Rule 2(c)(2) (petition
attachments); SPU Initial Order, issued Feb. 17, 2016 (ECF No. 5). During this time,
petitioner was represented by two different attorneys at the law firm of Mayer, Ross, &
3 Petitioner’s earlier case was designated Schandel No. 14-2010V.
2
Hagan. P.C., initially Damon Hagan and then Christopher Ross.4 On thirteen different
occasions, in orders or during status conferences, Mr. Hagan and Mr. Ross were
provided guidance regarding the medical records still needed, specifically those records
needed to establish vaccination, to show petitioner’s prior condition, and to satisfy the
statutory six month requirement. See, e.g., Order, issued Apr. 1, 2016, at 1 (ECF No.
11); Order, issued Aug. 28, 2016, at 1 (ECF No. 17); Order, issued Jan. 3, 2017, at 1
(ECF No. 22). After failing to file properly the required medical records, on March 1,
2017, Mr. Ross was ordered to associate with another attorney familiar with the Vaccine
Program. (ECF No. 25).
From March through August 2017, petitioner managed to file, but not properly
label, her affidavit and some of the medical records still outstanding. (ECF Nos. 28, 34).
During this time, Mr. Ross failed to associate with another attorney. Instead, he filed
several status reports indicating he conferred with several attorneys, not admitted to
practice before the United States Court of Federal Claims, and one attorney, Bruce
Slane, who has and continues to practice in the Vaccine Program. (ECF Nos. 29, 35).
In July 2017, petitioner sought and was granted subpoena authority for her vaccine
record from Genovese Drugstore (Rite Aid). (ECF Nos. 32-34, 36-37).
On September 13, 2017, the undersigned conducted a status conference in this
case. Noting petitioner’s inability to file the medical records required and multiple
failures to comply with orders, the undersigned ordered Mr. Ross to associate with
another counsel who would be lead attorney for the case and to file a copy of the
subpoena served on Genovese Drugstore (Rite Aid). See Order, issued Sept. 14, 2017,
at 2 (ECF No. 39). On September 25, 2017, petitioner filed the subpoena, labeled as
additional documentation. (ECF No. 40). Bruce Slane entered an appearance on
November 15, 2017.
The next day, the OSM staff attorney managing this SPU case held a status
conference with the parties. The staff attorney noted petitioner had previously filed an
affidavit and documentation regarding the dismissal of her civil case but that additional
medical records were still needed. All agreed petitioner should re-file all medical
records previously filed, along with any additional medical records obtained. (ECF No.
44).
Petitioner filed her medical records in late February and early March 2018. See
Exhibits 1-12 (ECF Nos. 47-48, 50-51); Statement of Completion (ECF No. 49).
Petitioner filed an amended petition on March 20, 2018.
A status conference was held with the undersigned on April 19, 2018. Due to the
length of time the case had been pending, the undersigned proposed that she give her
initial, informal findings during the call. Both counsel agreed, but respondent’s counsel
qualified her lack of objection as being given prior to the completion of respondent’s
4When referring to these attorneys, the individual attorney’s name will be used. The term “petitioner’s
counsel” will be used only for petitioner’s current counsel, Bruce Slane.
3
review. The undersigned expressed her understanding of respondent’s circumstances
and position. She then made informal findings regarding the proof of vaccination, onset
of petitioner’s pain, prior condition, and progression of petitioner’s injury. See Order,
issued Apr. 26, 2018, at 2-3 (ECF No. 53). She also questioned petitioner’s counsel
regarding some of the specifics of petitioner’s treatment, possible missing medical
records, and the type of compensation being sought. Id. at 3. In particular, the
undersigned noted that it appeared the record from a November 4, 2011 visit to
petitioner’s primary care provider (“PCP”), Dr. Chan, when she first complained of her
right shoulder pain, was not included in the more recently filed medical records.5
Petitioner was ordered to file a status report, medical records, and an amended petition
which addressed the issues discussed. See Order, issued Apr. 26, at 3-4 (ECF No. 53).
Respondent was ordered to file a status report providing his tentative position regarding
the case within 30 days thereafter. Id. at 4.
During the subsequent two months, petitioner filed several status reports (ECF
Nos. 55-56), the outstanding medical records from petitioner’s November 4, 2011 visit to
Dr. Chan (Exhibit 13, ECF No. 58-1), and another amended petition (ECF No. 57). The
only difference between the amended petitions filed on March 20 and June 20, 2018 is
an additional paragraph included in the later filed June 20, 2018 petition, describing the
November 4, 2011 visit to Dr. Chan. See Second Amended Petition at ¶ 6 (ECF No.
57). In her May 24, 2018 status report, petitioner indicated she had submitted a
demand to respondent. (ECF No. 55).
On July 23, 2018, respondent filed a status report indicating he was willing to
engage in settlement discussions. (ECF No. 61). Approximately one month later, he
informed the undersigned that he responded to petitioner’s May 24, 2018 demand.
Status Report, filed Aug. 28, 2018 (ECF No. 63).
On October 1, 2018, in lieu of the joint status report which was ordered,
respondent filed a motion for a factual ruling. (ECF No. 65). Respondent indicated the
parties had reached an impasse in their settlement discussions. Referencing the
informal factual findings made by the undersigned in April 2018, respondent requested
“a formal ruling on the factual issues only.” Id. at 2. Respondent proposed that,
following the undersigned’s fact ruling, he could “put his position with regard to
entitlement on the record via a written brief.” Id. In his motion, respondent indicated
petitioner had no objection to his proposal. Id. Additionally, later that same day,
petitioner filed a status report confirming his lack of objection. (ECF No. 66).
During a status conference held with the OSM staff attorney on October 31,
2018, the parties confirmed petitioner was seeking compensation for pain and suffering
and unreimbursable expenses, and that the main area of disagreement involved the
appropriate amount of compensation for petitioner’s pain and suffering. Respondent’s
5The record from this visit was filed by petitioner’s former counsel, Mr. Ross, on May 10, 2017. See
Exhibit G at 44 (ECF No. 28-3). Petitioner also described this visit in her supplemental affidavit, filed on
July 28, 2017. See Supplemental Affidavit at ¶¶ 7-9 (ECF No. 34).
4
counsel further indicated respondent could file his Rule 4(c) report within 45 days of the
undersigned’s fact ruling.
II. Factual History
The medical records from petitioner’s PCP, Dr. Enoch Chan at Best Choice
Medicine, P.C., show that, prior to the vaccination alleged as causal, petitioner suffered
from gastroesophageal reflux disease (GERD) and several common illnesses. See
generally Exhibits 1, 6.6 In March of 2008, petitioner was seen by Dr. Chan for facial
numbness and a lump (determined to be a cyst) under her right arm. See Exhibit 6 at
32, 34. After petitioner complained of vertigo in September and October 2008, Dr. Chan
referred her to a neurologist. See id. 10-12.7
For her vertigo, petitioner saw Dr. Augustine Romano at Sound Neurology of
Port Jefferson, L.L.P (“Sound Neurology”). See Exhibit 68 at 5-6 (Dr. Romano’s
November 19, 2008 letter to Dr. Chan). Petitioner informed Dr. Romano that she had
suffered from dizziness for six months and had also experienced numbness in her
upper extremities upon waking. She described her numbness as worse on her left side.
Id. Dr. Romano diagnosed petitioner with likely benign positional vertigo, left side, and
possible bilateral carpal tunnel syndrome. Id. at 6. He noted petitioner was currently
working as a piano tuner. Id. at 5. He provided petitioner with exercises to perform at
home to treat her vertigo and instructed her to return in four weeks. He indicated he
would address further petitioner’s hand numbness at the next appointment and may
order a nerve conduction study. Id. at 6.
It appears that petitioner did not follow-up with Dr. Romano, and there is no
evidence that her dizziness and numbness continued. In February 2009, petitioner’s
heartburn was evaluated by Dr. Buscaglia, at Stony Brook University Physicians. See
Exhibit 6 at 1. She received further treatment for her GERD at Brookhaven
Gastroenterology Associates in 2010. See Exhibit 7. The same year, she underwent a
6 The majority of petitioner’s PCP records are contained in Exhibit 1 which is labeled as “Medical Records
from Best Choice, P.C.” However, it appears some are contained in Exhibit 6 which is labeled “Medical
Records from Stony Brook University Physicians.” It is not clear if the records were erroneously
combined or the Best Choice Medical Records appearing in Exhibit 6 are simply copies of Dr. Chan’s
records which were provided to this other provider. The undersigned will cite to the exhibit and page
number of each record as filed.
7 Because petitioner had multiple complaints at these visits, referrals also were given to an orthopedist for
what appears to be an injury and to a gastroenterologist for a routine colonoscopy. Exhibit 6 at 11. For
the injury, petitioner saw Dr. B. Thomas Kempf, a podiatrist, twice in October 2008, for what appears to
have been an injury to her left toe. Id. at 7-9; see https://www.healthcare4ppl.com/physician/new-
york/sayville/brent-thomas-kempf-1659483246.html (indicating Dr. Kempf is a podiatrist, last visited Nov.
2, 2018). Like some of petitioner’s PCP records, Dr. Kemp’s records were filed as part of the Stony Brook
records, Exhibit 6. See supra note 6.
8Like some of petitioner’s medical records from her PCP, Dr. Chan, Dr. Romano’s medical records from
Sound Neurology of Port Jefferson, L.L.P., were filed as part of the medical records from Stony Brook
University Physicians. See supra notes 6-7.
5
cardiac evaluation after experiencing pressure and pain in the left precordial area. See
Exhibit 8.
Petitioner received the influenza vaccination alleged as causal on October 20,
2011. Ultimately, petitioner obtained documentation which showed the type of vaccine,
the manufacturer, and the date of administration. See Exhibit 2. Although the
documentation showed the vaccine was administered intramuscularly, it did not specify
the exact location, in which arm it was given. Id. at 3.
Two weeks later, petitioner first complained of residual pain and reduced right
shoulder range of motion (“ROM”) since receiving the influenza vaccine in her right
deltoid to her PCP, Dr. Chan. Exhibit 13 at 1. At that November 4, 2011 visit, Dr. Chan
also noted that petitioner had been sick for two weeks. He diagnosed her with
bronchitis, prescribed medication to include Prednisone and Augmentin, and referred
her to an orthopedist. Id.
Petitioner was seen for her right arm/shoulder pain by Dr. Patricia DeRosa at
DeRosa Orthopedic Services, P.C. on November 7, 2011. At that visit, petitioner
reported sharp, constant, and severe pain in her right arm since her flu shot on October
20, 2011, and an inability to move or lift her arm. Exhibit 3 at 18. She indicated the flu
shot “was given in [her] upper arm on [the] shoulder.” Id. Dr. DeRosa described
petitioner’s ROM as limited externally and internally to 0 and 10 degrees respectively.
Id. Noting that petitioner was left handed, Dr. DeRosa diagnosed petitioner with
adhesive capsulitis and a possible rotator cuff tear in her right shoulder. She ordered
an MRI. Id. at 19.
The MRI of petitioner’s right shoulder was performed on November 10, 2011. It
revealed “[a] partial thickness 0.7 cm tear at the bursal surface of the supraspinatus
tendon,” subscapularis tendinosis, subacromial/subdeltoid bursitis, “[a] laterally down
sloping type II acromial configuration,” and “some synovial fluid at the glenohumeral
articulation.” Exhibit 5 at 1. “Muscular and tendinous structures including remaining
portions of the rotator cuff” were noted to be “unremarkable in signal and morphology.”
Id.
Petitioner was seen again by Dr. DeRosa on November 14, 2011. Stating that
she felt the same, petitioner described her pain as constant and complained of an
inability to move her right arm/shoulder. Exhibit 3 at 17. Dr. DeRosa recorded the
results of petitioner’s MRI and her physical examination and diagnosed her with
adhesive capsulitis and a rotator cuff sprain. She prescribed physical therapy. Id.
On November 18, 2011, petitioner attended her first PT session at NY Physical
Therapy and Wellness. The medical record from that visit accurately reflects Dr.
DeRosa’s diagnosis of right shoulder adhesive capsulitis and rotator cuff strain and
notes an onset date of October 20, 2011. Exhibit 9 at 9. Petitioner described her pain
as a sharp, stabbing pain in her right shoulder which occurred immediately upon
6
vaccination and intensified over the subsequent few days and/or weeks.9 Petitioner
was noted to have a limited ROM in her right shoulder, difficulty performing many tasks,
and an inability to sleep at night. Id. at 7, 9. In the initial evaluation by the physical
therapist, Robert Fazio, DPT, it was also noted that petitioner had an inability to dress
herself and had been unable to work for the past month. Id. at 7.
From November 18, 2011 through the end of February 2012, petitioner attended
39 PT sessions. Exhibit 9 at 1-4. In the latest progress note dated February 15, 2012,
petitioner was reported to have improved ROM, mobility, flexibility and strength. Id. at
5. Her pain was reduced, and petitioner was able to do more around the house and to
sleep better at night. Id. It appears that petitioner’s last session was on February 27,
2012. See id. at 1.
While attending PT, petitioner had follow-up appointments with Dr. DeRosa on
January 6 and February 24, 212. See Exhibit 3 at 8, 14. It appears that, during this
time, she also sought a second opinion from Dr. Stephen Kottmeier at Stony Brooks
Orthopaedic Associates, on January 11, 2012. Exhibit 4 at 4-5. In the record from that
visit, petitioner’s injury is described as “painful [and] limited right shoulder ROM . . .
coincident with a flu shot received on 10/20/2011.” Id. at 4. Dr. Kottmeier opined that
the immediateness of petitioner’s symptoms “suggest[ed] either issues from a
mechanical aspects [sic] of the injection or potentially post-injection adhesive capsulitis
or even more commonly of brachial neuritis.” Id. While noting that petitioner described
occasional pain beyond her elbow joint, Dr. Kottmeier noted petitioner did not have a
“history of cervical, radicular or likely neurogenic discomfort of other origin.” Id. Dr.
Kottmeier observed the results of petitioner’s MRI suggested “features of rotator cuff
tendinopathy, potentially a partial articular surface tear.” Id. He concluded petitioner
“has signs and symptoms of adhesive capsulitis, potentially coincident with regional
injection” but acknowledged an alternative source of brachial neuritis. Id. at 5. He
offered petitioner a neurologic assessment and/or subacromial injection, both of which
she declined. Instead, petitioner indicated that she preferred to continue her PT. Id.
Petitioner had one more visit with Dr. DeRosa on July 6, 2012. At that visit, she
reported that she was “doing better,” but her ROM was described as poor. Exhibit 3 at
6. Petitioner indicated that her shoulder “pops [and] snaps,” and that she goes to PT
three times a week.10 Id.
While receiving treatment from Dr. DeRosa, petitioner was not seen by her PCP,
Dr. Chan. She returned to Dr. Chan on December 15, 2012 for a cold and cough.
Exhibit 1 at 98. Dr. Chan diagnosed her with bronchitis and prescribed medication.
Although parts of this record are difficult to read, it appears there is no mention of
ongoing shoulder pain at this visit. See id. at 98-99.
9 In two different places in the record from this visit, the intensifying of petitioner’s pain is described as
occurring over the next few days and then the next few weeks. Compare Exhibit 9 at 7 with id. at 9.
10 No PT records from this time frame were filed.
7
On February 8, 2013, petitioner was treated by Dr. Chan for shooting pain down
her right leg. Exhibit 1 at 93. He diagnosed her with back pain and ordered a nerve
conduction study. Id. The results of the study, performed on February 23, 2013, were
normal. Id. at 89. Petitioner saw Dr. Kottmeier on April 19, 2013 for bilateral pain in her
hands. Exhibit 4 at 1. She reported that this pain caused her difficulty with her work as
a piano tuner. Id. X-rays were taken, showing no abnormalities. Id. at 2-3.
On three more occasions in 2013, twice in 2014, four times in 2016, and once in
early 2017, petitioner was treated by Dr. Chan for various illnesses. See Exhibit 1 at 2-
3, 5-6, 9, 10, 12-13, 70, 85. Right shoulder pain was not mentioned in the medical
records from any of these visits. However, the medical records from Dr. Chan include a
letter, dated May 14, 2016, indicating petitioner was “under [his] care for right shoulder
pain due to flu vaccine [which] [t]o this date still causes her pain and discomfort.” Id. at
1.
On November 29, 2017, petitioner saw Dr. Barry Kleeman at Advanced
Orthopedics, for an evaluation of her right shoulder pain. She told Dr. Kleeman that
“she believe[d] her shoulder pain started after she had a flu shot for her right shoulder
approximately 3 years ago.” Exhibit 10 at 1. Describing pain with overhead activities,
petitioner indicated she had been unable to take care of her shoulder pain because she
was caring for her sick parents. After examining petitioner, Dr. Kleeman reported that
she had full, but painful, forward flexion and abduction of her right shoulder, internal
rotation on the left to mid-thoraic level and on the right to L1, no weakness on internal
rotation, and some pain on external rotation. He also noted that petitioner showed “a
positive Neer’s and Hawkins sign and she is neurovascularly intact.” Id. X-rays showed
no fractures, dislocations, or injuries. Dr. Kleeman ordered an MRI and prescribed over
the counter NSAIDs. Id.
III. Parties’ Arguments
The parties have not set forth any arguments regarding the factual issues in this
case. Rather, they request that the undersigned address the issues and make any
findings she deems appropriate based on the record as it currently stands.
IV. Discussion
A. Applicable Legal Standard
A petitioner must prove, by a preponderance of the evidence, the factual
circumstances surrounding her claim. § 13(a)(1)(A). 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).
8
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)).
Although this petition was filed prior to the inclusion of SIRVA on the Table, the
Qualifications and Aids to Interpretation (“QAI”) for SIRVA should be considered
instructive regarding the criteria for determining whether a SIRVA exists. Effective for
petitions filed beginning on March 21, 2017, SIRVA is an injury listed on the Table. See
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,
Final Rule, 82 Fed. Reg. 6294 (Jan. 19, 2017); National Vaccine Injury Compensation
Program: Revisions to the Vaccine Injury Table, Delay of Effective Date, 82 Fed. Reg.
11321 (Feb. 22, 2017) (delaying the effective date of the final rule until March 21, 2017).
The QAI for SIRVAs states:
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) (2017).
9
B. Factual Findings
During a status conference with the parties, held telephonically on April 19, 2018,
the undersigned made informal factual findings regarding the proof of vaccination, onset
of her pain, prior condition, and clinical course of her injury. (ECF No. 53). The
undersigned sets forth those findings in this section. Additionally, she finds there is
preponderant evidence to establish petitioner received the influenza vaccination alleged
as causal in her right arm.
1. Vaccination
Petitioner first attempted to file her proof of vaccination on January 15, 2017,
almost eleven months after filing her petition. (ECF No. 24-1). Unfortunately, the
record filed was a billing record which appears to be for another individual. Id.
Petitioner filed a record with additional information on May 10, 2017, but that record also
was for the individual on the earlier billing record. (ECF No. 28-1).
While still represented by former counsel, Mr. Ross, petitioner sought and was
granted subpoena authority to obtain the correct vaccine record on July 24 and 28,
2017.11 After Mr. Slane entered his appearance, petitioner filed a billing record with her
name on it and a vaccine record providing further information, such as the fact that the
vaccine was administered intramuscularly. See Exhibit 2, filed Feb. 22, 2018 (ECF No.
47-2). Although the page containing the additional information did not include
petitioner’s name, the prescription number on both records match. Compare id. at 1
with id. at 3.
The undersigned finds the vaccine record sufficient to establish petitioner
received the influenza vaccination alleged as causal, intramuscularly on October 20,
2011.
2. Site of Vaccination
Even though the vaccine record does not indicate in which arm the vaccination
was administered, there is sufficient evidence in the record to establish that petitioner
received the influenza vaccination in her right injured arm. At her initial visit with the
three medical providers who treated her injury within one month of vaccination,
petitioner identified her pain and/or vaccination as occurring in her right arm/shoulder.
See Exhibits 13 at 1; 3 at 18; 9 at 9 (ordered by date, earliest to latest). When she first
sought treatment, petitioner told Dr. Chan she had received the vaccination in her right
deltoid. This record also identifies petitioner’s pain and limited ROM as occurring in her
right shoulder. Exhibit 13 at 1. When she first saw Dr. DeRosa on November 7, 2011,
11 Petitioner filed a motion for subpoena authority on July 19, 2017 which included only the names of the
two companies on which the subpoena was to be served. (ECF No. 33). After the OSM staff attorney
informed Mr. Ross that more information would be needed, petitioner filed an amended motion on July
28, 2017 (ECF No. 34). Petitioner’s motion was granted in two separate orders, one for each company
named. (ECF Nos. 36-37).
10
petitioner complained of severe right arm pain after receiving the influenza vaccination
given in her upper arm on the shoulder. Exhibit 3 at 18. To her physical therapist on
November 18, 2011, petitioner reported sharp stabbing pain in her right shoulder when
receiving the influenza vaccination. Exhibit 9 at 9.
Throughout her treatment, petitioner consistently identified her influenza
vaccination as occurring in her right arm and attributed her pain and limited ROM to this
vaccination. Even in more recent medical records, when seeking treatment, petitioner
reported the site of administration as her right arm. See Exhibit 10 at 1. There are no
entries which refer to the vaccination as being administered in any other site.
The undersigned finds there is preponderant evidence to establish petitioner
received the vaccination alleged as causal in her right injured arm.
3. Onset
Likewise, regarding the onset of petitioner’s pain, petitioner consistently reported
that it was immediate, upon vaccination. The record from petitioner’s initial visit with Dr.
Chan indicates she had residual pain after her vaccination. It appears to indicate
petitioner had felt the pain since vaccination but the writing and abbreviations used are
unclear. Exhibit 13 at 1. The medical records from Dr. DeRosa, however, more clearly
conveys this information. In that record, petitioner reported pain “since my flu shot.”
Exhibit 3 at 18. At her first appointment with her physical therapist on November 18,
2011, petitioner stated that her “symptoms started immediately upon getting the flu shot
this year . . . [when] she “felt sharp stabbing pain in her [right shoulder12].” Exhibit 9 at 9.
In the record from petitioner’s January 11, 2012 visit to Dr. Kottmeier, it is noted that
petitioner’s “symptoms were rather immediate.” Exhibit 4 at 4. All medical records
indicate petitioner’s pain was immediate, none show a delay in her pain.
The undersigned finds the onset of petitioner’s pain was immediate and thus,
within 48 hours of vaccination.
4. Prior Condition
Petitioner has filed medical records from her PCP from as far back as 2008.
These records show that petitioner, a piano tuner, complained of bilateral numbness in
her upper extremities and a cyst under her right arm in 2008. Exhibit 6 at 5, 32. In a
letter to Dr. Chan, Dr. Romano, the neurologist who evaluated petitioner for both
dizziness and her numbness, diagnosed her with vertigo and possible bilateral carpal
tunnel syndrome. Id. at 5-6. He provided petitioner with exercises to perform at home
to treat her vertigo and instructed her to return in four weeks. He indicated he would
address further petitioner’s hand numbness at that appointment and may order a nerve
conduction study. Id. at 6. There is nothing in the medical records to show that
petitioner followed up on these issues at that time.
12 The medical record contains a capitalized R in a circle and the abbreviation “Shld”. Exhibit 9 at 9
11
In April 2013, 18 months after vaccination and approximately nine months after
her last visit with Dr. DeRosa regarding her right shoulder pain, petitioner returned to Dr.
Kottmeier, the orthopedist she saw, in early January 2012, for a second opinion
regarding her right shoulder pain. At this April 19, 2013 visit, she complained of bilateral
pain in her hands. Exhibit 4 at 1. The pain was described as located in her thumbs and
wrists. Petitioner indicated the pain had begun over the last few months and was
interfering with her work as a piano tuner. Id. Dr. Kottmeier ordered x-rays, the results
of which were normal. Id. at 2-3. The notes regarding Dr. Kottmeier’s impression and
proposed treatment are illegible. Id. at 1 (lower right side of this document).
Although it is clear petitioner had pain or numbness in her hands both before and
after vaccination, these symptoms appear to be independent of her right shoulder/upper
arm pain and, most likely, due to carpal tunnel syndrome caused or exacerbated by
petitioner’s vocation as a piano tuner. In contrast, the pain, described by petitioner as
occurring immediately upon vaccination and suffered by petitioner through at least July
2012, appears to be independent of any pain or numbness petitioner suffered in her
hands. Petitioner consistently described her right shoulder/upper arm pain as sharp,
constant, and located only in that area. See, e.g., Exhibit 13 at 1.
The only exception is one description provided to Dr. Kottmeier in early January
2012. At that visit, petitioner reported that her pain occasionally radiated below her
elbow. See Exhibit 4 at 4. However, petitioner did not indicate that the pain reached
her hands. Additionally, she was not complaining of or being treated for pain or
numbness in her hands at that time. There is nothing in the medical records from prior
to vaccination to indicate petitioner had any pain or difficulties with her right upper arm
or shoulder prior to vaccination.
After reviewing the record as a whole, the undersigned finds there is
preponderant evidence that petitioner did not experience any prior issues with her right
shoulder/upper arm.
5. Clinical Course
Petitioner’s clinical presentation and diagnosis when she was seen by Dr.
DeRosa on November 7, 2011, and Dr. Kottmeier on January 11, 2012, are consistent
with a SIRVA injury. See Exhibits 3 at 18-19; 4 at 4-5. Petitioner’s pain occurred
primarily in her right shoulder and progressed to the point that she developed adhesive
capsulitis. Petitioner presented with pain at her follow-up visits and attended
approximately 39 physical therapy sessions in 2011-12. See Exhibit 9 at 1-3. She was
very compliant with her physical therapy and showed good range of motion (“ROM”) at
her last visit. See id. at 5.
Furthermore, the results of petitioner’s November 10, 2011 MRI are compatible
with a SIRVA injury. The MRI showed a partial thickness tear in the bursal surface of
the supraspinatus tendon, tendonitis, and bursitis. See Exhibit 5 (MRI results). There is
no potential alternative cause for petitioner’s right shoulder/arm pain.
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The undersigned finds the clinical course of petitioner’s injury mirrored what is
seen typically in a SIRVA.
V. Conclusion
Thus, the undersigned finds, based on the record as a whole, there is
preponderant evidence to establish that petitioner received the vaccination alleged as
causal intramuscularly in her right injured arm; that the onset of petitioner’s pain was
immediate, definitely within 48 hours of vaccination; that petitioner had no prior
condition involving her right shoulder/upper arm; and that the clinical course of
petitioner’s injury mirrored what is seen typically in a SIRVA.
Respondent shall file his Rule 4(c) report by no later than Friday, December
21, 2018.
The undersigned notes that the medical records show that since 2008, petitioner
has suffered from a variety of conditions, several of which involved pain in petitioner’s
back, right leg, and hands. She also received regular medical care from Dr. Chan
throughout this time, with the primary exception being a gap in treatment during 2015.
While engaging in informal discussions regarding the appropriate amount of
compensation in this case, the parties shall consider the factual history set forth and
findings made in this ruling. Petitioner shall file any additional updated medical
records, such as the results of the second MRI ordered by Dr. Kleeman in late
2017, by no later than Monday, December 10, 2018.
Any questions about this ruling and order or about this case generally may be
directed to OSM staff attorney, Stacy Sims, at (202) 357-6349 or email:
Stacy Sims@cfc.uscourts.gov.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
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