Lesher v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1076V
UNPUBLISHED
MARILYNNE LESHER, Chief Special Master Corcoran
Petitioner, Filed: July 2, 2020
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Findings of Fact; Onset; Prior
HUMAN SERVICES, Condition; Causation in Fact;
Influenza (Flu) Vaccine; Shoulder
Respondent. Injury Related to Vaccine
Administration (SIRVA)
Lawrence R. Cohan, Anapol Weiss, Philadelphia, PA, for Petitioner.
Christine Mary Becer, U.S. Department of Justice, Washington, DC, for Respondent.
FINDINGS OF FACT AND RULING ON ENTITLEMENT1
On August 8, 2017, Marilynne Lesher filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the
“Vaccine Act”). Petitioner alleges that she suffered a full-thickness rotator cuff tear in her
left shoulder caused in fact by an influenza (“flu”) vaccine she received on November 11,
2016. Petition at 1. The case was assigned to the Special Processing Unit of the Office
of Special Masters.
1
Because this unpublished fact ruling contains a reasoned explanation for the action in this case, I am
required to post it on the United States Court of Federal Claims' website in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the fact ruling will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
Based on the record as a whole and for the reasons discussed below, I find
Petitioner likely suffered a left shoulder injury caused by the November 2016 vaccination.
Furthermore, I find by preponderant evidence that Petitioner is entitled to compensation
under the Vaccine Act.
I. Relevant Procedural History
Shortly after initiating the case, Ms. Lesher filed the required medical records.
Exhibits 1-5, ECF No. 7; Statement of Completion, ECF No. 8. Following the initial status
conference, Petitioner filed her affidavit regarding the requirements of Section 11(c).
Exhibit 6, ECF No. 10. Respondent was ordered to provide his tentative position on the
merits of Petitioner’s claim. Order, issued Sept. 29, 2017, ECF No. 9.
On April 4, 2018, Respondent filed a status report indicating he “intend[ed] to
continue to defend this case and [wa]s not interested in reviewing a settlement demand
at this time.” ECF No. 18. In his Rule 4(c) report, he argued that Petitioner’s injury did not
meet several of the requirements for a Table shoulder injury related to vaccine
administration (“SIRVA”). Rule 4(c) Report, filed June 4, 2018, at 8-9, ECF No. 21.
Regarding causation, he stressed that several of Petitioner’s treating physicians
expressed a belief that her shoulder injury was not vaccine caused. Id. at 8-9. He also
noted that Petitioner had not filed an expert report supporting her claim. Id. at 9.
On November 26, 2018, Petitioner filed a detailed affidavit regarding her left
shoulder injury, additional medical records including the vaccine consent form, and an
expert report, curriculum vitae (“CV”), and medical literature from Samir Mehta, M.D.
Exhibits 7-18, ECF Nos. 29-32. On April 19, 2019, Respondent filed an expert report, CV,
and medical literature from David Ring, M.D., Ph.D. Exhibits A-E, ECF No. 36.
Thereafter, this case was accepted for a test mediation program being
implemented by then-Chief Special Master Dorsey.3 The parties participated in a neutral
evaluation on December 16, 2019. See Status Report, filed Dec. 23, 2019, ECF No. 41
(joint status report from the parties). Following the mediation, Petitioner filed a handwritten
3
In 2019, 25 cases were selected by the parties to participate in a “Pilot-100” or “P-100” program designed
to facilitate the settlement of these cases. Under the P-100 program, these cases were scheduled for
neutral evaluation before a third-party neutral consistent with the U.S. Court of Federal Claims Procedure
for Alternative Dispute Resolution. See Rules for the Court of Federal Clams (“RCFC”) app. H. The P-100
program was overseen by then Chief Special Master Dorsey and me, after I was appointed Chief Special
Master on October 1, 2019. The P-100 program was terminated in January 2020.
2
note from one of her orthopedists, Michael J. Mehnert, M.D., representing his belief that
Petitioner’s left shoulder injury had been caused by the flu vaccine she received. Exhibit
19, ECF No. 40. On January 24, 2020, the parties filed a joint status report indicating the
mediation had failed and “Respondent has indicated [he] will continue to defend the
matter.”
After reviewing all evidence in this case, I determined the record was fully
developed and appropriate for a ruling on the written record as it currently stands.4
II. Relevant Factual History
Pre-Vaccination History
Petitioner’s medical records from her primary care provider (”PCP”), Julia Tiernan,
M.D., show that prior to vaccination, Petitioner suffered usual illnesses such as high blood
pressure and cholesterol, upper respiratory and gastrointestinal illnesses, irritable bowel
syndrome, occasional vertigo, and an episode of double vision and fatigue. Exhibit 2 at
86-95. She underwent gallbladder surgery in September 2013. Id. at 39-83, 101-102.
The only evidence of prior shoulder pain can be found in the medical record from
an October 21, 2013 visit to Petitioner’s PCP. Exhibit 2 at 99-100. At this follow-up
appointment for treatment of her high blood pressure, Petitioner complained of diarrhea
and left shoulder pain for two weeks. Id. at 99. It was noted that she had received a flu
vaccine in her left deltoid six weeks earlier. Id. Dr. McTiernan assessed Petitioner as
having a mild rotator cuff strain and possible viral gastroenteritis illness. Id. at 99-100.
She renewed Petitioner’s high blood pressure medication and instructed her to consume
increased fluids. Petitioner declined physical therapy (“PT”), but Dr. McTiernan indicated
she should undergo PT if her left shoulder pain worsened. Id. X-rays were taken which
showed mild osteoporosis. Id. at 112. There is no evidence that Petitioner pursued any
further treatment, and it appears Petitioner’s left shoulder pain had resolved by her next
visit to her PCP on July 30, 2014. Id. at 97-98.
At a follow-up appointment for high blood pressure the next year, on August 25,
2014, Petitioner noted that her vertigo had resolved but that she suffered from neck pain
4
Pursuant to Vaccine Rule 8, “[t]he special master may decide a case on the basis of written submissions
without conducting an evidentiary hearing.” As the Federal Circuit recently explained, a special master may
rule on the record after if he “determine[s] that the record is comprehensive and fully developed.”
Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020).
3
which gave her headaches. Exhibit 2 at 95-96. X-rays were taken which showed no
fracture but some evidence of cervical spondylosis.5 Exhibit 2 at 117. There is no mention
of neck pain at Petitioner’s next visit to her PCP, on July 23, 2015, when she was treated
for dizziness and vomiting. Id. at 93-94.
Receipt of Flu Vaccine in 2016
Petitioner was administered the flu vaccine alleged as causal at Walgreens
Pharmacy on November 11, 2016. Exhibit 1 at 4. The actual vaccine record indicates it
was administered intramuscularly, but it is not noted in which arm the vaccination was
given. Id. Petitioner has, however, filed the consent form which shows she received the
vaccination in her left deltoid. Exhibit 14 at 2.
Petitioner sought treatment for her left shoulder/upper arm pain from her PCP, Dr.
McTiernan, approximately six weeks later, on December 23, 2016. Exhibit 2 at 84-85.
She reported that she “got flu shot on November 1 [6] [and] [e]ver since then she has had
soreness and pain in her left shoulder/upper arm.” Exhibit 2 at 84. She described the
soreness and pain as getting better than worse in the last week. Reporting that she was
unable to lift her arm overhead, Petitioner indicated she had taken Aleve which had not
helped. “She denied any injury or overuse [of her] arm.” Id. Dr. McTiernan indicated
Petitioner should begin PT and should take Aleve for her pain. She added that she would
order an MRI if Petitioner’s pain had not resolved in four to six weeks. Id. Dr. McTiernan
opined that she did “not believe [Petitioner’s] shoulder pain [wa]s directly related to the
flu shot.” Id. at 85.
At her initial PT evaluation conducted on December 28, 2016, Petitioner portrayed
the onset of her left shoulder pain as sudden and insidious after receiving a flu shot in
early November. Exhibit 3 at 9. Reporting an initial lump and soreness which worsened
after two weeks, Petitioner described her current pain was constant and aggravated by
certain activities. Her prior function was characterized as “full and unrestricted.” Id. Upon
examination, Petitioner exhibited tenderness along the bicipital groove and decreased
strength and range of motion (“ROM”). Id. at 11.
5
Cervical spondylosis is a “degenerative joint disease affecting the cervical vertebrae, intervertebral disks,
and surrounding ligaments and connective tissue, sometimes with pain or paresthesia radiating along the
upper limbs as a result of pressure on the nerve roots.” DORLAND’S ILLUSTRATED MEDICAL DICTIONARY
(“DORLAND’S”) at 1754 (32th ed. 2012).
6
Either Petitioner provided the incorrect date of her vaccination or it was mistakenly recorded as occurring
on November 1, 2016. As shown in the vaccine record, Petitioner received the vaccine on November 11,
2016. Exhibit 1 at 4.
4
Petitioner attended eight more PT sessions during the remainder of December
2016 and into January 2017. Exhibit 3 at 14-29. Throughout this time, she showed good
progress (e.g., id. at 19) but some regression at specific appointments (e.g., id. at 22). At
her last visit on January 23, 2017, it was noted that Petitioner had shown “objective
improvements in shoulder ROM and strength” but no significant change in the level of her
pain. Id. at 29. Observing that Petitioner had an MRI scheduled, the therapist suggested
she consult with an orthopedist regarding her pain. Petitioner’s PT was placed on hold.
Id.On January 26, 2017, Petitioner underwent an MRI of her left shoulder. Exhibit 4
at 31. Approximately one week later, on February 2, 2017, she was seen by an orthopedic
surgeon, Shyam Brahmabbatt, M.D. at the Rothman Institute.7 Exhibit 4 at 20-22. She
again reported that her symptoms began in early November 2016 shortly after receiving
the flu vaccine. Id. at 20. Having received no relief from NSAIDs or PT, Petitioner
described her pain as throbbing, present even at rest, and “most severe on the
anterolateral aspect of her shoulder.” Id. “She also admit[ed] to some cervical spine
discomfort with radiation down her arm at times. Id.Dr. Brahmabbatt observed evidence of joint arthritis on both the x-rays performed
in December 2016 and MRI performed in 2017. Exhibit 4 at 20-21. The MRI also revealed
“evidence of a large tear of the supraspinatus tendon, . . . [a] tear of the infraspinatus
tendon, [i]ntramuscular cysts, . . . [and] subchondral bursitis.” Id. at 21; accord. id. at 31(results of the MRI). The MRI report indicated “[t]here [wa]s mild excess fluid within the
subacromial/subdeltold bursa.” Id. at 31. Given the atrophy seen with the chronic tears,
Dr Brahmabbatt informed Petitioner “that the rotator cuff tear [wa]s chronic and not due
to her recent vaccination.” Id. at 21. He recommended a cortisone injection, additional
PT, and possible surgery if Petitioner’s symptoms persisted. After obtaining Petitioner’s
consent, he administered a cortisone injection. Id.Petitioner was seen again by Dr. Brahmabbatt on March 6, 2017. Exhibit 4 at 18-
19. She reported that she had obtained a few weeks of relief from the cortisone injection
but that her pain had returned. Id. at 18. While mentioning Petitioner’s rotator cuff tear,
Dr. Brahmabbatt noted that “her pain started in November of 2016 when she had received
a flu shot and since then she has had throbbing laterally.” Id. Because the majority of
Petitioner’s pain was laterally based, Dr. Brahmabbatt wondered “if she [had] sustained
7
On the Rothman Orthopaedics website, Dr. Brahmabbatt is listed as “board certified in Orthopaedic
Surgery . . . specializing in arthroscopic surgery of the shoulder, knee, and hip as well as knee and shoulder
replacement surgery.” See https://rothmanortho.com/physicians/shyam-brahmabhatt-md (last visited on
June 26, 2020).
5
a neuropraxia of her axillary nerve due to the flu shot.” Id. He referred Petitioner to a
colleague for a discussion of nonsurgical options. Id.On March 21, 2017, Petitioner was seen by Edward Rosero, D.O. at the Rothman
Institute8 for her left shoulder pain. Exhibit 4 at 15-16. During his examination, Dr. Rosero
noticed tenderness of Petitioner’s left deltoid muscle and “some mild lower cervical facet
tenderness on the left side.” Id. at 15. Her cervical spine ROM was noted to be pain free.
Id. Dr. Rosero ordered an EMG and cervical MRI. Id. at 16.
Approximately one week later, on March 30, 2017, Petitioner was seen by Dr.
Mehnert at the Rothman Institute.9 Exhibit 4 at 12-14. At this visit, Petitioner again
recounted immediate pain after receiving the flu vaccine which she indicates was giving
too high on her shoulder. Id. at 12. Describing her prior treatment which had proved
ineffective, she rated her current level of pain as severe. Petitioner stated “[s]he ha[d] no
history of any prior cervical spinal injuries or prior neck injections.” Id. Dr. Mehnert
characterized the EMG performed during the visit as “a normal study.” Id.; see also id. at
23-25, 29-30 (EMG documentation and results). While observing that the EMG revealed
“borderline changes in the left median nerve compatible with a median sensory motor
neuropathy at the wrist,” he opined Petitioner “had no symptoms to suggest a true carpal
tunnel syndrome.” Id. at 12; see also id. at 29-30 (EMG results). He furthermore opined
there was “no clear electrodiagnostic evidence of cervical radiculopathy or brachial
plexopathy.” Id. at 12. He instructed Petitioner to undergo the cervical MRI ordered by Dr.
Rosero and to see him for a follow-up visit thereafter. Id. at 13.
After the cervical MRI, conducted on April 5, 2017 (Exhibit 4 at 27-28 (cervical MRI
results)), Petitioner attended a follow-up visit with Dr. Mehnert on April 21, 2017 (id. at 7-
8). Regarding the cervical MRI, Dr. Mehnert indicated there was “little in the way of left
foraminal stenosis in the cervical spine or any significant cord compression.” Id. at 7.
Because the MRI revealed a mass compatible with a neoplasm, he ordered a thoracic
MRI. He described the apparent thoracic spine mass lesion as “a separate issue.” Id.Regarding her left shoulder pain, which Petitioner rated at a level of 10 out of 10,
Dr. Mehnert stated that he “d[id] not see any clear evidence of cervical radiculopathy
8
On the Rothman Orthopaedics website, Dr. Rosero is listed as “[d]ouble [b]oard certified by the American
Board of Physical Medicine and Rehabilitation, specializ[ing] in non-operative sports medicine with
emphasis on treatment of sports injuries, joint pain, low back pain, neck pain and sports related
concussion.” See https://rothmanortho.com/physicians/edward-rosero-do (last visited on June 26, 2020).
9
On the Rothman Orthopaedics website, Dr. Mehnert is listed as a board-certified physical medicine and
rehabilitation specialist . . . [with] a subspecialty certification in Sports Medicine. See
https://rothmanortho.com/physicians/michael-j-mehnert-md (last visited on June 26, 2020).
6
causing her symptoms.” Exhibit 4 at 7. While noting the degenerative changes shown on
the earlier left shoulder MRI, he opined that some of the unusual characteristics of
Petitioner’s pain caused him to believe Petitioner’s shoulder injury “may in fact be related
to a vaccine reaction.” Id. He prescribed an “ultrasound-guided left shoulder bursa
injection” to treat Petitioner’s left shoulder pain. Id.Petitioner underwent a thoracic MRI on May 3, 2017. Exhibit 11 at 4. An
ultrasound-guided injection was performed by Lindsey Szymaszek, D.O.10 on May 23,
2017. Exhibit 4 at 4-5.
Approximately one week later, on May 30, 2017, Petitioner returned for a follow-
up appointment with Dr. Mehnert. Exhibit 4 at 33-34. At this visit, she reported that her
level of pain had been reduced to 4-5 out of 10 and her ROM had improved. Id. at 33. Dr.
Mehnert opined that Petitioner appeared to have “[l]eft shoulder bursitis and [a] possible
component of synovitis,[11] [and] [s]he does not seem to have a frank radiculopathy.”
Exhibit 4 at 33. Recognizing that Petitioner “[wa]s making progress albeit slowly,” Dr.
Mehnert instructed her to follow-up with him or Dr. Szymaszek in two to three months. Id.On June 15, 2017, Petitioner was seen by a neurosurgeon, Steven J. Barrer, M.D.,
at Abington Jefferson Health. Exhibit 10 at 8. At this visit, Dr. Barrer indicated Petitioner
had an asymptomatic, slow growing, and most likely benign meningioma in the thoracic
spine which was discovered incidentally during the work-up for her left shoulder pain.
Noting that the mass was unrelated to Petitioner’s shoulder pain, he recorded that
Petitioner “ha[d] no back pain, no arm pain or numbness, no leg numbness, [and] no
difficulty with her gait or sphincter problems.” Id. Given Petitioner’s age, he recommended
against surgery but indicated Petitioner should be scanned at four months then six
months thereafter to determine the rate of growth. Id. A second thoracic MRI, performed
on October 4, 2017, showed “mild associated mass effect upon the cord, [n]o other
lesions, . . . [and] no other areas of abnormal enhancement.” Id. at 31. The MRI also
“show[ed] no canal stenosis or neural foramen narrowing.” Id.When Petitioner returned for a follow-up visit with Dr. Mehnert on August 7, 2017,
she reported “excellent relief” after the ultrasound-guided injection in late May 2017 but
some “recurrent pain.” Exhibit 7 at 7. It was noted that she exhibited good ROM and some
10
It appears Dr. Szymaszek now practices medicine at PSF Primary Care Health Care Services which is
part of Centura Health. On the Centura Health website, she is listed as “a board-certified sports and family
medicine physician.” See https://www.centura.org/provider-search/lindsey-szymaszek-do (last visited on
June 26, 2020).
11
Synovitis is “inflammation of a synovium; it is usually painful, particularly on motion, and is characterized
by a fluctuating swelling due to effusion within a synovial sac.” DORLAND’S at 1856.
7
pain with movement. Characterizing Petitioner’s condition again as persisting and
ongoing bursitis, Dr. Mehnert instructed her to return in another month for a second
ultrasound-guided injection. He explained that he preferred to administer these injections
at least three months apart. Id. Dr. Szymaszek administered a second ultrasound-guided
injection on September 5, 2017. Id. 4-5.
At her next appointment on January 9, 2018, Dr. Szymaszek noted that after her
last injection, Petitioner had obtained “close to complete resolution of [her] discomfort until
about 4 weeks ago.” Exhibit 9 at 4. After examining Petitioner, Dr. Szymaszek reported
tenderness over the lateral shoulder, a positive Hawkins test, and negative cross body
test. Id. She described Petitioner’s condition as “established left shoulder pain and
underlying impingement syndrome associated with a complete rotator cuff tear” and
administered a third ultrasound-guided injection. Id. at 5.
On February 1, 2018, Petitioner was seen by her PCP for a follow-up appointment
to discuss recent bloodwork. Exhibit 10 at 50. Updates regarding her asymptomatic spinal
mass and left shoulder pain were included in the history section. While reporting that “it
aches when she uses her arm” (id.), Petitioner declined any pain medication (id at 51). It
was noted in this record that, in the past, pain medication had not helped and “PT made
[her symptoms] worse.” Id. at 50.
There is nothing in the record as it currently stands to show Petitioner has since
required further treatment of her left shoulder pain. In late April 2018, she visited the
emergency room at Lansdale Hospital twice with complaints of leg pain and headaches.
Exhibit 10 at 30, 34-46 (April 26, 2018 visit for leg pain); 32-33 (April 30, 2018 visit for
headaches). Petitioner visited her PCP on May 2, 2018 for a follow-up appointment
regarding her leg pain, headaches, nasal congestion, and hormone therapy replacement.
Id. at 47-48.
On December 20, 2019, Petitioner filed a handwritten note from Dr. Mehnert
purported to be his note regarding Petitioner’s diagnosis. Exhibit 19, ECF No. 40. The
note states “Intraarticular Vaccination or Vaccine Injection.” Id. at 2 (original with all letters
capitalized).
III. Findings of Fact
Petitioner’s medical records contain preponderant evidence supporting factual
findings on several issues relevant to the determination of entitlement in this case. As the
Federal Circuit has stated, contemporaneous medical records are presumed to be
8
accurate. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir.
1993). The Circuit Court explained that
Medical records, in general, warrant consideration as trustworthy evidence.
The records contain information supplied to or by health professionals to
facilitate diagnosis and treatment of medical conditions. With proper
treatment hanging in the balance, accuracy has an extra premium. These
records are also generally contemporaneous to the medical events.
Id. Petitioner’s contemporaneously created medical records reveal the following: 1) that
the onset of her pain likely occurred immediately upon vaccination; 2) that she previously
complained of left shoulder pain which resolved without treatment on one occasion, but
three years prior to vaccination; 3) that she has an spinal mass, unrelated to her left
shoulder condition which appears to be asymptomatic, slow growing, and benign; and 4)
that she suffered from an age-related rotator cuff tear which appears to have developed
prior to vaccination.
A. Onset of Petitioner’s Pain
Respondent argues that Petitioner has not established that the onset of her pain
occurred within 48 hours of vaccination because she did not seek medical treatment until
more than 40 days after vaccination. Rule 4(c) Report at 8. In addition, when Petitioner
did first seek care (on December 23, 2016), she generally indicated her pain had occurred
“following” vaccination but did not specify an onset within 48 hours. Id. at 9. Indeed,
Respondent notes that as of this appointment Petitioner stated that her “pain had abated
and had only worsened within the last week.” Id.
It is common for a SIRVA petitioner to delay treatment, thinking his/her injury will
resolve on its own, and not otherwise realizing the potential significance of immediate
post-vaccination pain. Thus, and contrary to Respondent’s urgings, I do not give great
weight to the fact that Petitioner did not seek treatment until December 23, 2016. The
date of this appointment is not unreasonably long after Petitioner’s November 2016
vaccination, and also reflects the first instance post-vaccination that she sought medical
treatment – and her specific reason was to address left shoulder pain she maintained had
been present “[e]ver since” vaccination. Exhibit 2 at 84.12
12
Although at this December appointment Petitioner noted a slight improvement then regression in her pain,
there is nothing to indicate Petitioner’s pain had resolved at this time – and indeed she thereafter continued
to seek treatment for it.
9
In addition, I note that throughout the medical records, Petitioner consistently
described the onset of her left shoulder pain as occurring in early November 2016 when
she received the flu vaccine, allowing for an unrebutted inference that the pain occurred
within a day or two of vaccination.13 Although these histories were provided by Petitioner,
they were relayed to medical providers for the purpose of obtaining medical treatment
during the initial six-month period after vaccination.
Based upon the record in this case, I find there is preponderant evidence which
establishes the onset of Petitioner’s left shoulder pain occurred close in time to
vaccination, and more likely than not within 48 hours of vaccination.
B. Prior Shoulder Issues
The medical records show that prior to vaccination, Petitioner briefly complained
of left shoulder pain in October 2013. She indicated she had experienced her pain for two
weeks and noted she had received a flu vaccine six weeks prior. Exhibit 2 at 99. There is
no evidence, however, that Petitioner complained of left shoulder pain thereafter until she
received the flu vaccine alleged as causal in late 2016. It appears that the left shoulder
pain Petitioner experienced in 2013 resolved without treatment. I find this report of pain
was the only mention of shoulder issues during the three years prior to vaccination. There
is nothing to indicate Petitioner experienced any other symptoms or issues related to her
left shoulder prior to vaccination.
Regarding the spinal mass seen on the cervical MRI conducted on April 5, 2017
and thoracic MRIs conducted on May 3 and October 4, 2017, the mass appears to be a
co-morbidity, unrelated to the left shoulder symptoms Petitioner was experiencing at that
time. Petitioner’s neurosurgeon clearly stated this conclusion in the record from her
appointment on June 15, 2017. Exhibit 10 at 8.
Finally, there is preponderant evidence to show that Petitioner suffered a rotator
cuff tear which most likely developed slowly due to age-related degenerative changes in
her left shoulder. Both Drs. Brahmabbatt and Mehnert observed the degenerative
changes in Petitioner’s left shoulder. Exhibits 4 at 21, 7 (respectively).
13
Petitioner described a sudden onset during appointments with Dr. McTiernen on December 23, 2016
(Exhibit 2 at 84); with her physical therapist on December 28, 2016 (Exhibit 3 at 9); with Dr. Brahmabbatt
on February 2 and March 6, 2017 (Exhibit 4 at 18, 15); with Dr. Rosero on March 21, 2017 (id. at 15); with
Dr. Mehnert on March 30 and April 21, 2017 (Id. at 12, 7); and with Dr. Szymaszek on May 23, 2017 (id. at
4).
10
IV. Expert Reports
A. Petitioner’s Expert
Petitioner provided an expert report from Samir Mehta, M.D., an Associate
Professor at the Department of Orthopaedic Surgery and Chief of the Orthopaedic
Trauma and Fracture Service at the University of Pennsylvania. Exhibit 15 at 7. According
to Dr. Mehta’s CV, he received his M.D. from Temple University School of Medicine in
2000 and has been board certified by the American Board of Orthopedic Surgeons since
2010. Exhibit 16 at 1-2. Since obtaining his medical degree, he has received numerous
fellowships, faculty, and hospital appointments and awards, lectured on a variety of
topics, and contributed to or wrote multiple articles and books. Id. at 1-69.
In his expert report, Dr. Mehta provided a brief summary of Petitioner’s relevant
medical history and treatment. Exhibit 15 at 1-2. He mistakenly noted that Petitioner never
complained of prior left shoulder pain but correctly observed that Dr. Mehnert opined
Petitioner’s symptoms after November 2016 were likely related to the vaccine she
received. Id. at 2.
Dr. Mehta’s report discussed the results of the x-rays, MRIs, and EMG undergone
by Petitioner in detail. Exhibit 15 at 2. Regarding the left shoulder MRI performed on
January 26, 2017, Dr. Meht observed that the characteristics of Petitioner’s rotator cuff
tear indicate it was not caused by trauma. He opined that the results of the EMG and
cervical MRI do not show any pathology or conditions related to Petitioner’s left shoulder
pain. Id.
Dr. Mehta concluded that the left shoulder pain and limited ROM suffered by
Petitioner was a direct result of the flu vaccine she received on November 11, 2016.
Exhibit 15 at 2, 5. He characterized the onset of Petitioner’s pain as immediate. Id. at 3.
Noting that Petitioner’s chronic rotator cuff tear was asymptomatic prior to vaccination, he
maintained there are no other conditions that would explain Petitioner’s symptoms. Id.
Discussing the medical literature provided with his report, which outlines the
mechanisms by which vaccines cause shoulder injuries, Dr. Mehta concluded that the
vaccine administered to Petitioner was injected into the glenohumeral joint, causing an
inflammatory response which was aided by her previously asymptomatic rotator cuff tear.
Exhibit 15 at 3-6.14
14
Dr. Mehta also indicated his view that all of the causation-in-fact prongs have been satisfied by the
evidence in this case. Ex. 15 at 5; see also Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278
(Fed. Cir. 2005). Of course, it is not for medical experts to opine on the satisfaction of the legal prongs that
Vaccine Program claimants must meet, and so I give this aspect of his opinion little to no weight.
11
B. Respondent’s Expert
Respondent’s expert report is from David Ring, M.D., Ph.D., the Associate Dean
for Comprehensive Care and Professor of Surgery and Psychiatry at the University of
Texas at Austin. Exhibit A at 1. Dr. Ring’s CV shows he earned his medical degree in
1993 from the University of California, San Diego, Medical School. Exhibit B at 1. For
almost eight years, Dr. Ring was an instructor, Associate Professor, and then Professor
of Orthopaedic Surgery at Harvard Medical School. Id. In 2006, he earned a Ph.D. in the
Psychosocial Aspects of Arm Pain from the University of Amsterdam. He is board certified
in orthopedic surgery and hand surgery. Exhibit A at 1. Like Dr. Mehta, Dr. Ring has
received numerous fellowships, faculty, and hospital appointments and awards, lectured
on a variety of topics, and contributed to or wrote multiple articles and books. Exhibit B at
1-99.
In his expert report, Dr. Ring indicated he is “particularly expert in the
psychological and social determinants of illness; in particular the way in which the normal
functioning of the human mind creates misconceptions that can contribute to greater
symptoms and limitations.” Exhibit A at 1. He further states he has treated patients with
shoulder issues in his clinical practice since 2000 and has treated approximately 50
patients with adhesive capsulitis in the last five years. He has “studied and written on the
misconception of common arm idiopathic or age appropriate conditions as new or an
injury,” testifying five times in the last five years. Id.As a preliminary matter, Dr. Ring specified that he considers “the probability of the
administration of an immunization causing permanent pathophysiology in the shoulder [to
be] extremely low,” and stressed that other matters such as age-related degeneration
“should be taken into consideration when evaluating a SIRVA claim.” Exhibit A at 1.
Regarding Petitioner’s case, Dr. Ring concluded the evidence does not establish
that she suffered an injury meeting the Table requirements for SIRVA. 15 Exhibit A at 1.
15
The most recent version of the Table, which can be found at 42 C.F.R. § 100.3, identifies the vaccines
covered under the Program, the corresponding injuries, and the time period in which the particular injuries
must occur after vaccination. Section 14(a). Pursuant to the Vaccine Injury Table, a SIRVA is compensable
if it manifests within 48 hours of the administration of an influenza vaccine. 42 C.F.R. § 100.3(a)(XIV). The
criteria establishing a SIRVA under the accompanying QAI are as follows:
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,
12
He found Petitioner at best had met the third QAI criterion, that Petitioner’s pain and
decreased ROM were limited to the shoulder in which the vaccination was administered
but failed to meet the other three QAI criteria. Id. at 3.
Like Petitioner’s expert, Dr. Ring opined that the results of the left shoulder MRI
established that the Petitioner’s rotator cuff tear is the result of age-related changes rather
than acute trauma. Exhibit A at 2. Both experts stressed that one would not see the fatty
atrophy visible on Petitioner’s MRI had the rotator cuff tear been due to injury. Id.; Exhibit
15 at 2.
In his report, Dr. Ring argued the existence of this age-related rotator cuff tear
meant Petitioner’s left shoulder injury failed to meet both the first and last QAI criteria of
a Table SIRVA. Exhibit A at 3. When advancing this argument, Dr. Ring did not explain
why Petitioner’s rotator cuff tear which was previously asymptomatic, except for one
complaint of pain in 2013, would have been the sole cause of the severe left shoulder
pain Petitioner reported in 2016 and 2017. Nor did he acknowledge that the one earlier
complaint of pain, in 2013, which also shared a temporal relationship to an administered
flu vaccine, was the only evidence of the “prior shoulder problems” he referenced. Id. at
1.
Regarding the onset of Petitioner’s pain, Dr. Ring appeared to conflate onset with
the point when Petitioner sought medical care. Thus, he twice asserted that Petitioner did
not seek medical care within 48 hours, when arguing Petitioner had failed to satisfy this
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).
13
second Table criterion – even though onset in the Program is measured from
manifestation of symptoms rather than when first diagnosed. Section 14(a); see, e.g.,
Amos v. Sec’y of Health & Human Servs., No. 90-0851V, 1991 WL 146275, at *2-3 (Fed.
Cl. Spec. Mstr. July 17, 1991). Dr. Ring otherwise did not address the three-prong
causation-in-fact test set forth in Althen, 418 F.3d at 1278.
V. Ruling on Entitlement
Before compensation can be awarded under the Vaccine Act, a petitioner must
demonstrate, by a preponderance of evidence, all matters required under Section
11(c)(1). Section 13(a)(1)(A). In making this determination, the special master or court
should consider the record as a whole. Section 13(a)(1). Petitioner’s allegations must be
supported by medical records or by medical opinion. Id.In addition to requirements concerning the vaccination received, the duration and
severity of petitioner’s injury, and the lack of other award or settlement,16 a petitioner must
establish that she suffered an injury meeting the Table criteria, in which case causation
is presumed, or an injury shown to be caused-in-fact by the vaccination she received.
Section 11(c)(1)(C).
A. Table Injury: SIRVA
I have determined there is preponderant evidence to establish that the onset of
Petitioner’s left shoulder pain occurred immediately upon vaccination. Thus, she has met
the timing required for a Table SIRVA, fulfilling the second of the four QAI Table criteria.
The third criteria (that Petitioner’s pain and decreased ROM was limited to her left
shoulder) has also been met preponderantly, based on my review of the record. Indeed,
Dr. Ring (whose report focused only on the age-related rotator cuff tear suffered by
Petitioner and did not mention the spinal mass or one report of occasional pain radiating
to Petitioner’s fingers and neck) seems to have conceded this, and it appears that, like
Petitioner’s treating physicians, he viewed her other prior symptoms as unrelated.
However, the medical record does not preponderantly support the first and fourth
criteria for a Table SIRVA. The first criterion requires “[n]o history of pain, inflammation or
16
In summary, a petitioner must establish that she received a vaccine covered by the Program,
administered either in the United States and its territories or in another geographical area but qualifying for
a limited exception; suffered the residual effects of her injury for more than six months, died from her injury,
or underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or
collected an award or settlement for her injury. See Section 11(c)(1)(A)(B)(D)(E).
14
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.” 42 C.F.R. § 100.3(c)(10)(i). The fourth criterion
requires that “[n]o other condition or abnormality is present that would explain the patient’s
symptoms.” 42 C.F.R. § 100.3(c)(10)(iv). Although brief, Petitioner’s earlier report of left
shoulder pain, coupled with the rotator cuff tear shown on the MRI which appears to have
developed over time, prevents her from satisfying these requirements for a Table SIRVA.
As a result, to be entitled to compensation Petitioner must show that the flu vaccine
she received on November 11, 2016 caused her left shoulder pain and limited ROM, and
therefore needed to satisfy the evidentiary elements established for a causation-in-fact
claim.
B. Causation-in-Fact: SIRVA
If a petitioner suffered a shoulder injury that does not meet the requirements for a
Table SIRVA, she may still receive damages, if she can prove that the administered
vaccine caused injury to receive Program compensation. Section 11(c)(1)(C)(ii) and (iii).
In such circumstances, the petitioner asserts a “non-Table or [an] off-Table” claim and to
prevail, must prove her claim by preponderant evidence. Section 13(a)(1)(A). The Federal
Circuit has held that to establish an off-Table injury, petitioner must “prove . . . that the
vaccine was not only a but-for cause of the injury but also a substantial factor in bringing
about the injury.” Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1351 (Fed.
Cir 1999). Id. at 1352. The received vaccine, however, need not be the predominant
cause of the injury. Id. at 1351.
The Federal Circuit has indicated that a petitioner “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The
Federal Circuit subsequently reiterated these requirements in a three-pronged test set
forth in Althen, 418 F.3d at 1278. Under this test, a petitioner is required
to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination and
injury.
15
Id. All three prongs of Althen must be satisfied. Id. Circumstantial evidence may be
considered, and close calls regarding causation must be resolved in favor of the
petitioner. Id. at 1280.
Although the first and second prongs of Althen appear to be similar, these analyses
involve different inquiries. See Doe 93 v. Sec’y of Health & Human Servs., 98 Fed. Cl.
553, 566-67 (2011). The first prong focuses on general causation, whether the
administered vaccine can cause the particular injury suffered by the petitioner, and the
second prong focuses on specific causation, whether the administered vaccine did cause
the injury. Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir.
2006). his distinction “has been described as the ‘can cause’ vs. ‘did cause’ distinction.”
Stapleton v. Sec’y of Health & Human Servs., No. 03-234V, 2009 WL 1456441, at *18
(Fed. Cl. Spec. Mstr. May 1, 2009).
1. First Althen Prong
In determining that Petitioner has satisfied the first Althen prong, I take judicial
notice of the fact that Respondent has added SIRVA after receipt of an intramuscularly
administered seasonal influenza vaccine to the Table. Such recognition of the causal link
between vaccine and injury has been held to support the establishment of the theory
require by the first Althen prong, since it suggests the existence of reliable medical or
scientific evidence supporting the “can cause” prong. See Doe 21 v. Sec'y of Health &
Human Servs., 88 Fed. Cl. 178, 193 (2009), rev’d on other grounds, 527 Fed. Appx. 875(Fed. Cir. 2013). Indeed – in proposing the Table addition of SIRVA, Respondent
discussed the scientific evidence regarding the means by which this injury is caused –
and in so doing specifically referenced two articles also offered in connection with Dr.
Mehta’s report. See National Vaccine Injury Compensation Program: Revisions to the
Vaccine Injury Table, 80 Fed. Reg. 45132, 45136-37 (July 29, 2015); S. Atanasoff et al.,
Shoulder injury related to vaccine administration (SIRVA), 28 Vaccine 8049 (2010), filed
as Exhibit 17(b) (ECF No. 31-2) (“Atanasoff”); M. Bodor and E. Montalvo, Vaccination
Related Shoulder Dysfunction, 25 Vaccine 585 (2007), filed as Exhibit 17(d) (ECF No.
31-4) (“Bodor”).
The mechanism set forth in Atanasoff is described as “the unintentional injection
of antigenic material into synovial tissues resulting in an immune-mediated inflammatory
reaction.” Atanasoff at 8049. As its authors indicated, this results in an inflammatory
response which may be prolonged due to pre-existing antibody in the synovial tissue from
an earlier naturally occurring infection or vaccination. Id. at 8051. They also observed that
bursitis and greater fluid in the bursa were two of the findings often seen in MRI studies
16
of vaccine injured shoulders. Atanasoff further mentioned that many of the patients they
studied may have had prior conditions such as rotator cuff tears which became
symptomatic following the improper vaccine injection. To distinguish this type of vaccine-
related shoulder injury from conditions caused by a mechanical injury or overuse, the
authors pointed to “the rapid onset of pain with limited range of motion following
vaccination” which was seen in the patients they studied. Id. at 8051. Bodor provides
additional support for this proposed mechanism. Exhibit 17(d).
I find the evidence discussed above comprises preponderant evidence sufficient
to show that the seasonal influenza vaccine, when administered intramuscularly but
improperly injected in the synovial space, can cause an inflammatory response resulting
in shoulder injury. Petitioner has established that the seasonal influenza vaccine can
cause SIRVA by this described mechanism, and thus, has satisfied the first Althen prong.
2. Second Althen Prong
The second Althen prong requires proof of a logical sequence of cause and effect,
usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d
at 1278; Andreu ex rel. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1375-
77 (Fed. Cir. 2009)); Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317, 1326
(Fed. Cir. 2006); Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed.
Cir. 1992). In establishing that a vaccine “did cause” an injury, the opinions and views of
the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at
1367; Capizzano, 440 F.3d at 1326 (“treating physicians are likely to be in the best
position to determine whether a ‘logical sequence of cause and effect show[s] that the
vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280).
In his expert report, Dr. Mehta opined that the flu vaccine Petitioner received was
incorrectly administered in her glenohumeral joint, causing an inflammatory response
which was aided by her previously asymptomatic rotator cuff tear. Exhibit 15 at 3-6. He
clarified that
[w]hile I do not believe the vaccination caused her rotator cuff tear, I do
believe her previously asymptomatic rotator cuff tear created a region for
her shoulder pain to reside once the vaccine was likely administered
improperly. Or, said another way, her existing rotator cuff tear increased the
likelihood that the inflammatory reaction would include the glenohumeral
joint. As a result, it is plausible that such a scenario would create ongoing
complaints of shoulder pain in the glenohumeral and/or rotator cuff region.
Her MRI is consistent with this.
17
Id. at 5-6.
The evidence contained in Petitioner’s medical records supports a finding that the
flu vaccine caused her shoulder injury in a manner consistent with Dr. Mehta’s opinion.
As I previously found, except for a report of a pain in 2013 for a few weeks following an
earlier vaccination, Petitioner’s left shoulder rotator cuff tear was asymptomatic until she
received the flu vaccine in early November 2016. Upon vaccination, however, she
experienced immediate pain and developed limited ROM which was observed at her initial
PT evaluation. Exhibit 3 at 11. Subchondral bursitis and mild excess fluid in the bursa
were noted on Petitioner’s left shoulder MRI. Exhibit 4 at 21, 31. As Atanasoff’s authors
observed, similar symptoms and characteristics were shared by many of the patients they
studied. Atanasoff at 8051.
Admittedly, treater support for the second prong is mixed – although ultimately it
preponderates for Petitioner. Dr. McTiernan unquestionably indicated in December 2016
that she did not believe Petitioner’s shoulder injury was related to the flu vaccine she
received, but (as Dr. Mehta astutely noted) Dr. McTiernan is a primary care provider who
would not be as knowledgeable about shoulder injuries. Exhibit 15 at 6. The orthopedists
who initially treated Petitioner were, by contrast, only unsure of the cause of her left
shoulder pain. For example, Dr. Brahmabbatt noted the existence of the rotator cuff tear
seen on Petitioner’s MRI which he opined was age-related and not caused by the flu
vaccine she received. Exhibit 4 at 21. Nevertheless, due to the sudden onset of
Petitioner’s pain immediately following vaccination, he later theorized the flu shot may
have caused an injury to her axillary nerve, and thus referred her to Dr. Rosero who
ordered an EMG and cervical MRI. Id. at 18.
It was only after the results of this additional testing were obtained, the unrelated
spinal mass was discovered, and the lack of cervical or neurological symptoms related to
Petitioner’s shoulder injury was confirmed that Dr. Mehnert finally opined that Petitioner’s
left shoulder pain may in fact have been caused by the flu vaccine. Exhibit 4 at 7. At that
visit, he prescribed an ultrasound-guided injection which provided substantial relief. The
next time he saw Petitioner, Dr. Mehnert described her injury as bursitis with a possible
component of synovitis. Id. at 33. He later provided a handwritten note to Petitioner
indicating that he believed her vaccination caused her left shoulder injury. Exhibit 19. As
Dr. Mehta noted in his expert report, Dr. Mehnert’s comments regarding causation “are
more persuasive given that shoulder injuries are his expertise as a sports medicine
physician at the Rothman Institute.” Exhibit 15 at 6.
18
Petitioner’s treatments are also consistent with a vaccine-caused shoulder injury.
In total, Petitioner received three ultrasound-guided injections. As noted by Atanasaoff,
an ultrasound-guided injection is the optimal treatment for the SIRVA they described.
Atanasoff at 8051. And the opinion provided by Dr Mehta aligns with the information
provided throughout Petitioner’s medical records. The record in this case thus contains
preponderant evidence that the flu vaccine Petitioner received on November 11, 2016 did
not case her rotator cuff tear as Petitioner originally alleged but did caused her left
shoulder pain and decreased ROM.
3. Third Althen Prong
The third Althen prong “requires preponderant proof that the onset of symptoms
occurred within a timeframe for which, given the medical understanding of the disorder’s
etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of Health
& Human Servs., 539. F.3d 1347, 1352 (Fed. Cir. 2008). As Dr. Mehta noted in his expert
report, in the majority of SIRVA cases, the petitioner has suffered pain within 48 hours of
vaccination, with many cases presenting more immediate pain (i.e. in less than a day).
This sudden onset is a key component of the theory advanced by Dr. Mehta – and,
consistent with my fact findings above, it is present in this case. Accordingly, Petitioner
has satisfied the third Althen prong.
VI. Conclusion
Having reviewed the affidavits, medical records, expert reports, and
documentation in this case, I find that Petitioner has provided preponderant evidence to
establish causation-in-fact. Based on the entire record in this case, Petitioner has proven
that the flu vaccine she received on November 11, 2016, likely caused her to suffer pain
and reduced ROM in her left shoulder. Petitioner is therefore entitled to compensation
under the Vaccine Act. A damages order will be issued setting the next deadline in this
case.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
19