“[L]ike any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking.”
How later courts described this case
- “[L]ike any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking.”
Written by the judges who cited it.
The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-1192V
Filed: January 11, 2020
* * * * * * * * * * * * * * *
MEGAN C. MCFADDEN, * To Be Published
*
Petitioner, *
v. * Finding of Facts; Onset; Influenza (“Flu”)
* Vaccine; Shoulder Injury Related to
SECRETARY OF HEALTH * Vaccine Administration (“SIRVA”)
AND HUMAN SERVICES, *
*
Respondent. *
*
*
* * * * * * * * * * * * * * *
Alexander Laufer, Esq., Eisenhower and Laufer, PC, Fairfax, VA, for petitioner.
Mark Hellie, Esq., U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ONSET1
Roth, Special Master:
On September 23, 2016, Megan McFadden (“petitioner” or “Ms. McFadden”) filed a
petition pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et
seq.2 (“Vaccine Act” or “the Program”). Petitioner alleged that as a result of a quadrivalent
influenza (“flu”) vaccination she received on September 28, 2013 she developed a shoulder injury
related to vaccine administration (“SIRVA”). Petition at 1, ECF No. 1. For the detailed reasons set
forth below, I find that petitioner developed a shoulder injury related to the receipt of a flu vaccine
within 24 hours of receiving her September 28, 2013 flu vaccine.
1 This Ruling has been designated “to be published,” which means I am directing it to be posted on the
Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347,
116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). This means the Ruling will
be available to anyone with access to the internet. However, the parties may object to the Ruling’s
inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each par ty
has fourteen days within which to request redaction “of any information furnished by that party: (1) that is
a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes
medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of
privacy.” Vaccine Rule 18(b). Otherwise, the whole Ruling will be available to the public. Id.
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
The petition was filed on September 23, 2016, along with petitioner’s af fidavit and medical
records. See Petition, Petitioner’s Exhibits (“Pet. Ex.”) 1-5, ECF No. 1. This case was initially
assigned to the Special Processing Unit (“SPU”). ECF No. 4. Petitioner filed additional medical
records on October 4, 2016. Pet. Ex. 6-8, ECF No. 6.
Following the initial status conference on November 9, 2016, petitioner was ordered to file
her primary care records for three years prior to vaccination. Scheduling Order, ECF No. 8.
Petitioner filed the additional medical records on January 9, 2017. Pet. Ex. 9-10, ECF No. 10.
Respondent filed his Rule 4(c) Report (“Resp. Rpt.”) on April 10, 2017, recommending
against compensation in this matter. ECF No. 15. It was respondent’s position that petitioner’s
claim did not satisfy the criteria for an on-Table SIRVA injury. Resp. Rpt. at 6 n.7. Specifically,
respondent pointed out that the contemporaneous medical records did not “document complaints
of shoulder pain until a visit on March 7, 2014, nearly six months after vaccination, at which time
[petitioner] stated that her pain began around November 2013 and was due to picking up her child.”
Id. at 7. Respondent noted that the history given by petitioner placed the onset of her shoulder pain
“approximately two months after her vaccination.” Id. Respondent further noted that petitioner
“sought medical treatment six times between the date of her vaccination and the March 2014 visit,
and there is no mention of left shoulder pain in the records of any of those visits.” Id. Additionally,
petitioner reported in March 2014 that her pain “was associated with lifting her child” and placed
onset one month after vaccination. Id. Respondent pointed out that petitioner did not associate her
shoulder pain with a vaccination until April 4, 2014, during a phone call to Fort Belvoir; she did
not mention her alleged vaccine-related shoulder pain to any of her treating doctors in Okinawa,
Japan. Id.
Respondent also noted that petitioner was inconsistent in reporting the timing of onset.
Resp. Rpt. at 8. Petitioner initially reported to Fort Belvoir that her shoulder pain started five days
post-vaccination, but “when she saw Dr. Montgomery on April 30, 2014,” she reported “that her
left shoulder pain began ‘within 24 hrs.’ of her vaccination and that her pain reached a ‘peak’ five
days later.” Id. Additionally, respondent requested that petitioner provide “addition[al] evidence
documenting the administration of the flu vaccine that is the subject of her claim.” Id. Respondent
noted that petitioner reported a different vaccination date to Fort Belvoir, and that there was no
office visit documenting administration of the allegedly causal vaccine. Id. at 8-9.
Following the filing of respondent’s Rule 4(c) Report, an Order was issued for petitioner
to file additional evidence documenting vaccine administration as well as a detailed affidavit
addressing the factual issues raised by respondent, including the onset of her symptoms and her
lack of complaints of shoulder pain between October 2013 and March 2014. Scheduling Order at
1-2, ECF No. 16.
During a status conference on July 14, 2017, petitioner’s counsel advised that he was in
the process of obtaining additional medical records from the military. Scheduling Order at 1, ECF
No. 19. Respondent requested that petitioner also file records of any medical care she received
while in Hawaii and Seattle. Id. Petitioner filed a status report (“Pet. S.R.”) on August 7, 2017,
2
advising that she was still in the process of obtaining her medical records from the military;
petitioner also advised that she had not received any treatment for her alleged shoulder injury in
Seattle or Hawaii. Pet. S.R. at 1, ECF No. 20. Petitioner later filed a Motion to Issue Subpoena to
obtain her medical records from the military; this motion was granted. See ECF Nos. 26-27. The
medical records were ultimately filed on December 30, 2017. Pet. Ex. 17, ECF No. 31. After
reviewing the medical records, respondent filed a status report (“Resp. S.R.”) on January 30, 2018,
advising that he was not open to settlement negotiations. Resp. S.R. at 1, ECF No. 35.
This matter was reassigned to me on February 5, 2018. ECF Nos. 36-37.
On February 20, 2018, petitioner filed an “opinion letter” from one of her treating
physicians, Dr. Montgomery. Pet. Ex. 18, ECF No. 38. His letter provided a summary of the
medical record from petitioner’s appointment on April 30, 2014, discussion of petitioner’s MRI
taken on May 2, 2014, and his reasoning for why he diagnosed petitioner with SIRVA. See Pet.
Ex. 18 at 1-2. Dr. Montgomery wrote “based upon other etiologies having been ruled out through
interview, physical and radiographic examination, the reported vaccination technique, the
chronology and character of her symptoms, and her demographics, it was my opin ion that Ms.
McFadden’s condition was most consistent with “Shoulder Injury Related to Vaccine
Administration” (SIRVA).” Id. at 2.
A status conference was held on March 28, 2018; petitioner’s counsel requested a fact
hearing to resolve the issues raised by respondent. Scheduling Order at 1, ECF No. 39.
An onset hearing was initially scheduled for December 12, 2018 but had to be rescheduled
when petitioner’s husband was deployed to the Middle East. See Scheduling Order at 1, ECF No.
41; Scheduling Order at 1, ECF No. 43. The onset hearing was ultimately held on July 17, 2019,
in Washington, D.C. See Scheduling Order at 1, ECF No. 45; Scheduling Order at 1, ECF No. 46.
Petitioner and her husband testified via video conference. Scheduling Order at 1, ECF No. 54.
Following the hearing, petitioner filed a certificate of course completion for Dr. McFadden
in support of his testimony. See Pet. Ex. 19, ECF No. 55. Petitioner filed a status report on August
6, 2019, advising that she did not intend to file a post-hearing brief. Pet. S.R., ECF No. 58.
II. SUMMARY OF EVIDENCE
A. Petitioner’s Medical Record
a. Petitioner’s History Prior to the Flu Vaccine
Petitioner was born on February 19, 1988. Her past medical history is for the most part
noncontributory. Only that which is pertinent is included herein. See Pet. Ex. 9 at 415; 432-539.
In 2012, petitioner suffered from migraines, esophageal reflux, cervical muscle spasms,
nonallopathic lesions, irregular uterine bleeding and tachycardia. Pet. Ex. 9 at 401, 378 -431. On
July 17, 2012, she presented to her medical provider with complaints of muscle spasm and cervical
somatic dysfunction. She underwent osteopathic manipulation and acupuncture. Pet. Ex. 9 at 401.
3
On September 25, 2012, petitioner presented with a chief complaint of right arm redness and pain.
She was noted to have a five centimeter circumferential area of cellulitis to the right inner
arm/axilla, with a small area of induration to the superior portion of the cellulitis. Pet. Ex. 9 at 388-
89. She was prescribed clindamycin, Keflex, and ibuprofen. Id. at 389. On September 28, 2012,
petitioner presented for a civilian fitness exam, was determined to be a candidate for the Ft. Polk
Civilian Fitness program for six months of participation. Pet. Ex. 9 at 393.
In 2013, she became pregnant. The pregnancy was complicated by hy pertension. Pet. Ex.
9 at 283, 286, 290-376; Pet. Ex. 7.
Petitioner gave birth on September 19, 2013 at 41 plus weeks while stationed in Okinawa,
Japan. The baby was delivered by Caesarian section (“C-section”) due to arrested descent. Pet. Ex
11 at 2. The infant was admitted to the level two neonatal intensive care unit (“NICU”) for
observation and monitoring due to maternal chorioamnionitis,3 maternal fever, fetal tachycardia, 4
uterine tenderness and foul-smelling amniotic fluid. Pet. Ex. 11 at 2-3. The baby suffered persistent
hypoglycemia 5 and mild thrombocytopenia.6 Pet. Ex. 11 at 3. On October 10, 2013, at three weeks
of age, the baby was sent by medevac to Tripler Army Medical Center (“TAMC”) in Oahu, Hawaii
for evaluation for pulmonary insufficiency/hypoxemia after he was unable to be weaned from
oxygen. Pet. Ex. 11 at 10; Pet. Ex. 14 at 1. He was admitted to TAMC NICU where he was
subsequently weaned from oxygen and discharged with an apnea monitor. After discharge, he had
several episodes of oxygen desaturation to 89% on room air while in deep sleep. There was concern
for central sleep apnea. Pet. Ex. 11 at 11. On November 15, 2013, he was admitted over night as a
two-month-old to the Pediatric Sedation Center for MRI with sedation using Propofol. Pet. Ex. 11
at 11. On November 25, 2013, he was flown from Oahu, Hawaii to Seattle Children’s Hospital
where he was hospitalized until December 16, 2013 when he was flown back to Torii Station,
Japan. Pet. Ex. 14 at 4; Pet. Ex. 13. He was ultimately diagnosed with sleep apnea, which has since
resolved. Pet. Ex. 11 at 14.
b. Petitioner’s History Following the Flu Vaccine
Following the birth of her son on September 19, 2013, petitioner received the allegedly
causal flu vaccine on September 28, 2013, at the U.S. Naval Hospital in Okinawa, Japan. Ex. 1 at
1; Pet. Ex. 9 at 111; Pet. Ex. 2 at 1. Petitioner affirmed receipt of the vaccination “high and anterior
on her left deltoid,” after which she “experienced immediate discomfort that grew to pain within
hours.” Pet. Ex. 2 at 1.
3Chorioamnionitis is an infection involving the chorion, amnion, and amniotic fluid; usually the placental
villi and decidua are also involved. STEDMAN’S MEDICAL DICTIONARY § 172930 (2015), Westlaw.
4Fetal tachycardia is a fetal heart rate of 160 or more beats per minute. STEDMAN’S MEDICAL
DICTIONARY § 1895210 (2015), Westlaw.
5Hypoglycemia is the condition and symptoms of low blood glucose. STEDMAN’S MEDICAL DICTIONARY
§ 428850 (2015), Westlaw.
6Thrombocytopenia is the condition in which an abnormally small number of platelets is present in the
circulating blood. STEDMAN’S MEDICAL DICTIONARY § 918040 (2015), Westlaw.
4
One month later, on October 29, 2013, petitioner telephoned her primary care manager
(“PCM”) requesting a punch biopsy. The purpose and location were not included in the record, but
she was referred for an appointment. Pet. Ex. 9 at 277-78. The record does not document any
complaint of shoulder pain.
On January 3, 2014, petitioner presented for a lesion on her upper left shoulder and biopsy
of the pigmented area. Pet. Ex. 9 at 271. She also requested a referral for dermatological consult
for a lump on her finger. Pet. Ex. 9 at 271-72. There was no mention of left shoulder pain. A shave
biopsy was performed to the left shoulder after lidocaine with epinephrine injection was
administered. Pet. Ex. 9 at 273. A pigmented nevus was removed from the petitioner’s left upper
shoulder. Id.
Petitioner presented to her PCM due to dyspareunia 7 on January 8, 2014. Pet. Ex. 9 at 267-
69. There was no mention of any left shoulder pain.
On January 16, 2014, petitioner presented for follow up of ulcerative proctitis. Pet. Ex. 9
at 265. The record documents “no systemic symptoms, no head symptoms, no neck symptoms…no
musculoskeletal symptoms, no neurological symptoms…” Pet. Ex. 9 at 265.
The following day, January 17, 2014, petitioner presented for removal of the lesion/lump
she previously complained about on her left fifth finger. Pet. Ex. 9 at 260 -61. She reported a
papular like lesion on the palmar surface of her left 5 th finger present for 3 months. Pet. Ex. 9 at
262. The lesion was removed, and petitioner was educated on how to recognize skin cancer. Pet.
Ex. 9 at 261. The record does not document any complaint of shoulder pain.
Petitioner had a telephone encounter on January 29, 2014 in which the results of the lesion
removed from her left fifth finger were explained. Pet. Ex. 9 at 257-58.
On January 30, 2014, petitioner presented to her gynecologist for dyspareunia. Pet. Ex.
254-56. She was prescribed Premarin cream. Pet. Ex. 9 at 256. The record does not document any
complaint of shoulder pain.
On March 7, 2014, petitioner presented to her PCM for trouble reading and four months of
left shoulder pain possibly from picking up her newborn so frequently. She denied trauma, redness,
bruising or swelling. She reported pain on certain motions and rated her pain severity a four out of
ten. Upon examination her physician found tenderness along her left deltoid and abnormal motion.
Pet. Ex. 9 at 251-53. The record noted that petitioner was “feeling pain free today.” Pet. Ex. 9 at
251. She reported that her husband’s friend performed a “Graston”8 procedure which had helped.
Pet. Ex. 9 at 248, 252. She was referred to physical therapy (“PT”). Pet. Ex. 9 at 253.
7Dyspareunia is the occurrence of vaginal pain during sexual intercourse. STEDMAN’S MEDICAL
DICTIONARY § 273400 (2015), Westlaw.
8 During his testimony, Dr. McFadden explained the Graston procedure as soft tissue mobilization.
Stainless steel bars are used to scrape the soft tissue and release the muscle tension that causes pain. Tr.
100.
5
On March 18, 2014, petitioner attended her PT evaluation. She reported left shoulder pain
with onset when turning to the left to pick up her baby five months ago. She reported that rest did
not help, and the pain kept her up at night. She reported less noticeable pain when she was not
carrying her son as much. Pet. Ex. 9 at 245. She reported that her husband is a doctor and diagnosed
the source of her pain as supraspinatus infraspinatus. Pet. Ex. 9 at 245. Her husband’s friend did a
maneuver that helped with the pain. Pet. Ex. 9 at 246; see Pet. Ex. 9 at 249.
Petitioner returned to her gynecologist for follow up of dyspareunia on March 25, 2014.
Pet. Ex. 9 at 243-44.
Petitioner attended four PT sessions through April 4, 2014 and reported that her pain had
been reduced to a two out of ten. Pet. Ex. 9 at 230-42.
On April 4, 2014, petitioner called the Vaccine Health Center Clinic to report arm pain
after a flu vaccine received on October 5, 2013. She reported that the “vaccinator was standing up
and she was seated when the shot was injected.” She recalled telling her husband that “it hurt a
lot”. Pet. Ex. 9 at 229. She reported that she received the vaccine in the Pediatric Clinic that was
giving flu shots that day at Camp Foster. She recalled having pain about five days later which has
continued until the present. It hurt with certain movements. Id. The assessment and plan on the
record stated, “Arthralgia – Shoulder Region Left. May be due to influenza injection given high in
the deltoid area near bursa. Will see and examine patient when she comes to NoVa 9 area in latter
part of April ’14.” Id.
On April 30, 2014, petitioner presented to Dr. Montgomery at the Vaccine Health Center
Clinic in Fort Belvoir Community Hospital in Fort Belvoir, Virginia. She reported left shoulder
pain for seven months. She reported that she was not involved in strenuous activity beyond
carrying her newborn son. She reported the onset of focal left shoulder pain within about 24 hours
of receiving a flu shot in October. She indicated that the site of injection was high and anterior on
her deltoid. She recalled no redness bruising or swelling of the area. The pain reached a peak within
about 5 days; it waxed and waned with activity. She tried Motrin and PT without significant or
long-lasting relief. The pain was localized high on her deltoid and would radiate mid-way down
her lateral arm. She denied weakness, distal paresthesia, or loss of range of motion. She noticed
the most discomfort with internal rotation/adduction of her arm. Pet. Ex. 3 at 1. Physical
examination revealed no deformity of the acromioclavicular joint or atrophy of the supraspinatus
or the infraspinatus muscles; there was isolated tenderness to palpation of the anterior superior left
deltoid. There was no tenderness of the acromioclavicular joint or subacromial tenderness and no
palpable trigger points around the shoulder. There was no lo ss of active and passive ranges of
motion. The Apley scratch test, Hawkins’ test, empty can supraspinatus test and cross-body
adduction test were all negative. Yergason’s test for biceps tendonitis and internal rotation were
positive, producing pain in her upper arm. Axial-loading of the cervical spine did not produce pain.
Dr. Montgomery’s assessment was arthralgia of the left shoulder. Pet. Ex. 3 at 1; Pet. Ex. 9 at 226-
27. Dr. Montgomery opined: “In the absence of other etiology, and given the vaccination
technique, SIRVA is a likely diagnosis.” Pet. Ex. 3 at 1-2; Pet. Ex. 9 at 227.
9 NoVa is an abbreviation for Northern Virginia.
6
Petitioner returned to Fort Belvoir for an MRI of the left shoulder on May 2, 2014. She
reported seven months of pain. Pet. Ex. 4 at 1-2; Pet. Ex. 10 at 2-3. The MRI revealed no joint
effusion, cartilage intact without defect, labrum unremarkable, mild tendinopathy of the rotator
cuff tendon, no evidence of tear, mild muscle edema. Pet. Ex. 4 at 1. The impression was small
intrinsic tear/strain to the very distal muscle fibers of the subscapularis, the tendon itself was
unremarkable through the insertion. Pet. Ex. 4 at 1; Pet. Ex. 9 at 223. Petitioner called the next day
for the result of her MRI. She was advised that the MRI showed a small tear in the distal muscle
fibers of the shoulder. She was given instructions for when she returned to Okinawa. Pet. Ex. 9 at
222-23.
On May 9, 2014, petitioner presented for follow up at Fort Belvoir and requested PT for
left shoulder injury that occurred “after a vaccine injection.” Pet. Ex. 9 at 217.
Petitioner returned to her primary care physician in Okinawa on July 7, 2014, requesting
follow up on medication and refills. Pet. Ex. 8 at 1. She had a long history of asthma well controlled
on Singulair and Zyrtec. She reported feeling well. She reported pain in the left shoulder with
movement. Pet. Ex. 8 at 1. She reported 30 minutes most days of moderate exercise. Pet. Ex. 8 at
3.
On July 29, 2014, petitioner returned to PT reporting left shoulder pain since October of
2013. She avoided activity that included her left shoulder. Her pain was reported as three to six
out of ten. Pet. Ex. 9. at 208. She attended PT on August 4, 2014 and August 7, 2014 with a report
of pain at three to four out of ten and zero to one out of ten, respectively . Pet. Ex. 8 at 205; 203.
On August 18, 2014, she reported she was improving and had begun to swim a little. Pet. Ex. 9 at
197. By August 28, 2014, she reported swimming twice a week, but her pain increased when
holding her son. Pet. Ex. 9 at 192. On September 15, 2014, she was “doing better” and was
swimming freestyle with no pain. All PT goals were noted as met. Pet. Ex. 9 at 182-83.
Petitioner had no other medical visits related to her left shoulder.
On November 6, 2015, petitioner presented for a flu vaccine. The record no tes no prior
reaction to vaccines. Pet. Ex. 9 at 135.
As of July 22, 2016, petitioner reported that she engages in 150 minutes of moderate
intensity exercise per week and muscle strengthening activities two or more days a week. Pet. Ex.
9 at 114.
B. Affidavits and Hearing Testimony
a. Petitioner’s Affidavits and Hearing Testimony
On September 14, 2016 and June 2, 2017, petitioner signed affidavits affirming that while
her son was in the neonatal intensive care unit (“NICU”) at the United States Naval Hospital in
Okinawa, Japan [following his birth on September 19, 2013], she was administered a flu vaccine.
Pet. Ex. 2 at 1; Pet. Ex. 15 at 1. Petitioner testified that she was living at the hospital from the time
7
her son was born until October 10, 2013, when he was transferred by medevac to Oahu, Hawaii.
Tr. 8. It was during this time at the hospital that she received the flu vaccination on September 28,
2013. Tr. 11; Pet. Ex. 2 at 1; Pet. Ex. 15 at 1. Petitioner explained that her primary focus was caring
for her son, and in doing so, it was very important for her to get the flu vaccine as she was cognizant
of not bringing the flu virus into the NICU and cautious with her own asthma condition. Tr. 9, 33.
According to petitioner, the United States Naval Hospital was holding a flu shot clinic for military
dependents at the pediatric clinic in the hospital which is where petitioner received her vaccine.
Pet. Ex. 15 at 1. Petitioner described the clinic as a “mass immunization clinic” where they were
“funneling people in and out of the clinic to get their shot.” Tr. 10.
According to petitioner, the shot was administered while she was seated, by a hospital
corpsman who was standing. Tr. 10; Pet. Ex. 15 at 1. Petitioner specifically recalled asking the
corpsman if she could sit down because she had been standing up for a while and , having just had
a C-section, was uncomfortable. Tr. 10, 79. She stated that the injection was administered high
and anterior on her left deltoid. Tr. 11; Pet. Ex. 15 at 1. According to petitioner, she experienced
immediate discomfort. Tr. 31; Pet. Ex. 15 at 1. She affirmed that when she returned to the NICU,
she told her husband that the shot was very painful. Tr. 10; Pet. Ex. 15 at 1. Petitioner stated the
pain grew within hours and continued to worsen, reaching its apex within five days , “by which
time it was a struggle to merely lift my newborn son.” Pet. Ex. 15 at 1. She testified that she
continually told her husband that her shoulder hurt and that the pain peaked at day five,
“particularly when I went to grab my son or pass him off.” Tr. 12. Petitioner stated that prior to
September of 2013, she had no shoulder pain or discomfort. Pet. Ex. 2 at 2.
Petitioner acknowledged calling her primary doctor to refill routine prescriptions on
September 26, 2013. Tr. 34.
Petitioner explained that due to her son’s health crisis, being evacuated to Hawaii and
ultimately to Seattle, she was forced to set aside her shoulder pain. Pet. Ex. 15 at 1. Petitioner
testified she did not even receive post-partum obstetrical care despite having a C-section during
this time because her husband would know if she needed exigent care. Tr. 16; Pet. Ex. 15 at 1.
Petitioner further testified that her husband, as a physician, told her that her shoulder would
probably need physical therapy, which she did not want to start in Hawaii. Tr. 40. Petitioner
explained that transferring care coverage to another region would be difficult and not necessarily
practical as they did not know how long their stay would be in Hawaii. Tr. 40. Petitioner also
testified that their time in Hawaii was a “horrible situation.” Tr. 40. She described a hotel room
above the hospital which was infested with cockroaches and termites. Tr. 37. She and her husband
did not go out much since they were on medevac orders. Tr. 39. She was breastfeeding on demand,
sleep-deprived, and her husband was dealing with her son’s complicated insurance coverage. Tr.
40. As a first-time mother dealing with the stress of her son’s condition, she admitted, “I was kind
of falling apart…” Tr. 16.
Petitioner addressed a medical record dated October 29, 2013, during their time in Hawaii,
that references a phone call she made to set up a punch biopsy. She explained that being fair
skinned she is “cognoscente of protecting myself against any marks/moles leading to potential skin
cancer.” Petitioner confirmed that the appointment was “unrelated to [her] shoulder pain and was
solely intended to avoid any further issues from a concerning sunspot.” Pet. Ex. 15 at 2. During
8
her testimony, petitioner further explained that she had seen a dermatologist all her life and made
time for a phone call to discuss a punch biopsy because she thought it was cancer. Tr. 36. Her
mother, who previously had skin cancer spots removed, was the one who noticed the spot
following Patrick’s birth. Her mother was concerned and encouraged petitioner to get the spot
examined. Tr. 22. A dermatologist had also previously told her that she may develop skin cancer
by the time she turned thirty years old; so, despite being preoccupied with caring for her son,
petitioner was quite concerned about her skin. Tr. 36. As to why she did not mention shoulder pain
in the phone call requesting a biopsy, petitioner explained that military medical appointments are
scheduled for specific concerns; one does not mention multiple or unrelated concerns for one
appointment. Tr. 22. Petitioner would not mention shoulder pain to dermatology and her shoulder
pain was at a different location than her skin spot. Id.
Petitioner testified that she and her husband did not know how long they would be in
Hawaii and did not expect to be transferred to Seattle at the end of November of 2013. Tr. 15, 18.
According to petitioner, her shoulder and upper arm pain worsened throughout this period of her
son’s treatment in Hawaii and Seattle. Pet. Ex. 2 at 2; Pet. Ex. 15 at 1. Petitioner testified “there
was constant pain with certain motions.” Tr. 47. Even though she tried to minimize motions that
generated pain, “you can’t compensate completely.” Tr. 47. Despite the pain, petitioner explained
that scheduling an appointment with a military physician and having to change TriCare coverage
was not her priority. Tr. 18; Pet. Ex. 15 at 1-2. “It was just a situation where I was not the patient
of concern. What I was focused on completely and utterly was my son, and, you know, it was my
first child…. My whole world was on my son and not on myself and the shoulder pain that I was
experiencing.” Tr. 13.
Petitioner affirmed that upon her return to Okinawa in December of 2013, she still had
much to do to take of her son, who had been diagnosed with sleep apnea . Tr. 17; Pet. Ex. 15 at 2.
She testified that from the time of his birth, to Oahu, Seattle and back to Okinawa, “my son was
still my primary concern. I was a first-time mom. My husband had a very busy job, and I didn’t
have a lot of friends on the island.” Tr. 19. She could not make appointments for herself until she
was able to find a reliable babysitter. Pet. Ex. 15 at 2. “I didn’t have anybody to leave Patrick with
to go to the hospital and take care of myself.” Tr. 19.
Petitioner addressed her various January 2014 visits to medical providers upon her return
to Japan stating that she did not mention any shoulder pain because, not having experienced
musculoskeletal injuries before, she “naively expected the ongoing pain to simply disappear.” Pet.
Ex. 15 at 2-3. She further explained that when she made these appointments for her skin,
genitourinary, and gastrointestinal issues, her understanding was each appointment addresses only
one issue. “Our appointments are 20 minutes long, and the physician or the physician’s assistant
isn’t going to address multiple issues at one time. That’s not how it works.” Tr. 22. Petitioner
addressed the punch biopsy of her left shoulder stating it was “not the same location as the
[shoulder] pain…It was kind of more toward my neck. It was a spot of concern.” Tr. 22, 51-52.
Petitioner further testified that her report of 0 out of 10 pain was related to the spot to be biopsied,
which was not painful. Tr. 51. Petitioner testified that the genitourinary appointment on January
8, 2014, was for vaginal pain, a more pressing issue and “not something that you’re going to want
to put off.” Tr. 53. Finally, the January 16, 2014 visit for ulcerative proctitis was a chronic health
issue for her and though she was asymptomatic, she was very careful about her condition because
9
her mother-in-law passed away from colon cancer. Tr. 54. She agreed that the record documented
no musculoskeletal complaints but stated she would not tell the GI doctor about a musculoskeletal
issue, just like she would not tell the gynecologist about shoulder pain when she was there for
vaginal pain on January 30, 2014. Tr. 55-56. Petitioner further added that the doctors at these visits
do not check for all the symptoms, they just note, “no symptoms” for everything unrelated the
visit. Tr. 74.
When explicitly asked why she did not seek treatment for her shoulder until March 2014,
petitioner testified, “It just wasn’t something that –you know, it was a complaint that I had with
certain ranges of motion. I was compensating for it, and it was something that I honestly thought
was going to go away and that I didn’t need to seek care for. I had my husband en couraging me to
seek care for it, but he said you’re probably going to have to do physical therapy. And I thought to
myself, what a nightmare. Who’s going to watch our child?” Tr. 58. Petitioner testified that all the
issues she saw doctors for in January of 2014 “were more pressing” than her shoulder pain. Tr. 22.
Petitioner ultimately sought care for her shoulder “because activities like closing the car
door just got to a point where it was unbearable, the pain…and then other things like lif ting up an
iPad, which is pretty light, in a certain range of motion, I couldn’t do it without significant pain.”
Tr. 21. She testified about seeing her husband’s coworker for a Graston procedure sometime later
in February or early March of 2014 “because that’s what was easy. My husband was able to just
take me upstairs and have his coworker look at my shoulder while my husband held my son.” Tr.
20.
Petitioner explained her various reports of onset. On March 7, 2014 when she presented
to the PMC, she did not have a calendar but wanted her providers to know that the “pain had been
ongoing since shortly after the birth of her son.” Pet. Ex. 15 at 2 ; Pet. Ex. 9. at 251. “I gave them
a ballpark, you know, it’s been hurting four or five months because I knew that it had been hurting
since around the time that Patrick had been born. But I’m not sitting there holding a calendar and
saying, okay, my shoulder started hurting on this day” Tr. 23. She stated at the time, she did not
know what caused her shoulder pain, thinking perhaps it was holding her newborn son that caused
her shoulder to hurt. Tr. 24. Respondent’s counsel pointed to the record that documents petitioner
as pain free at this visit. Petitioner disagreed with the record stating the physician was not writing
at the same time as petitioner was speaking, she had pain at that visit otherwise she would not have
been pursuing physical therapy. Tr. 48-49.
Petitioner was then asked why on March 18, 2014, she provided a five-month history of
shoulder pain when her son was six months old. Petitioner responded that she is “not that kind of
mom typically. I just was happy that I’d had my son” Tr. 79; Pet. Ex. 9 at 245. Petitioner was asked
what she meant when she reported the pain was less severe when she was not carrying Patrick as
much. She stated she meant the pain was less noticeable. Tr. 50; Pet. Ex. 9 at 245. The record
recorded her pain level as at “least 3.” Pet. Ex. 9 at 245.
Petitioner further explained that in March of 2014, her husband attended a seminar at which
he spoke to an immunization healthcare expert from Fort Belvoir, Virginia and learned of SIRVA
injuries. Pet. Ex. 2 at 2. When her husband returned home, he gave her a business card for Jeannette
William and suggested she call for information regarding her shoulder. Tr. 24. Petitioner spoke
10
with Ms. Williams, who asked her a series of detailed vaccine administration questions, and after
the discussion suggested petitioner go to Fort Belvoir to see Dr. Montgomery. Tr. 25, 76. The
record for the April 4, 2014 phone call noted that petitioner reported pain starting five days after
vaccination. Tr. 60; Pet. Ex. 9 at 229. Petitioner explained five days after vaccination was when
the pain peaked. Tr. 70.
Petitioner stated that she presented to Dr. Montgomery in Northern Virginia on April 20,
2014.10 Pet. Ex. 2 at 2. Petitioner testified that even when attending her appointment with Dr.
Montgomery, she did not know the vaccine was in fact the cause of her injury, “I didn’t go into
that appointment with any preconceived notions, or you know, I don’t go to the doctor to tell them
what my diagnosis is.” Tr. 25-26. The record by Dr. Montgomery notes that petitioner’s pain began
within 24 hours after vaccination. Tr. 62. Petitioner testified that the record was correct and that
she experienced pain immediately after vaccination. Tr. 63.
According to petitioner, after returning to Okinawa from Northern Virginia, she underwent
physical therapy from July of 2014 through September of 2014. The therapy provided
improvement, but the pain waxed and waned for over a year. Pet. Ex. 2 at 2. The record from
petitioner’s first physical therapy visit documented “left shoulder pain since October 2013” as her
chief complaint. Tr. 62. Petitioner stopped physical therapy appointments after September 15,
2014 because she had to secure a babysitter every time she went, and the therapist told her she
could do the exercises at home which required little to no equipment. Pet. Ex. 15 at 3. Her shoulder
pain was well controlled at that time as well. Pet. Ex. 15 at 3. Petitioner affirmed that she then
aggravated her shoulder carrying her son after a flight back to Northern Virginia in 2015.
Mentioning that her son weighed thirty-five pounds at that time, she testified that “the physical
therapy was essentially ruined.” Tr. 27; Pet. Ex. 2 at 2. Therapy no longer was helpful. Pet. Ex. 2
at 2. While she did not return to a formal physical therapy regimen, petitioner testified that she
saw a friend, John Hill for physical therapy sessions, intermittently, off-the-record, between 2014
and 2016. Tr. 66-67.
Petitioner submits that she is healthy, athletic and was previously a competitive swimmer.
She also used to participate in triathlons and half marathons. She states she is no longer able to run
or swim any stroke other than freestyle or perform the simplest of daily tasks that require raising
her left arm. Pet. Ex. 2 at 3. Even when swimming freestyle, petitioner testified that she
experiences some pain. Tr. 27. She cannot sleep on her left side. Tr. 71; Pet. Ex. 2 at 3.
b. Affidavit and Testimony of Petitioner’s Husband
Dr. McFadden, a family medicine practitioner in the military, affirmed that in September
of 2013 his son was born and hospitalized in the NICU for what was later determined to be sleep
apnea. The first three months after his birth were spent in the NICU and living out of hotels in
Hawaii or Seattle. Tr. 84-87; Pet. Ex. 16 at 1.
Dr. McFadden recalled petitioner receiving a flu vaccine at the hospital while their son was
in the NICU. Pet. Ex. 16 at 1. Dr. McFadden explained that the hospital held mass immunization
clinics. Tr. 90. He recalled petitioner reporting how painful her shot was when she returned from
10 This is incorrect. Petitioner saw Dr. Montgomery on April 30, 2014. Pet. Ex. 3 at 1.
11
the clinic; “I distinctly remember her telling me that that was the most painful immunization shot
that’s she’s ever received in her entire life. And that’s a direct quote ”. Tr. 90; Pet. Ex. 16 at 1.
According to Dr. McFadden, petitioner “reported a continued burning sensation in her shoulder
over the next several days.” Tr. 91; Pet. Ex. 16 at 5. Dr. McFadden stated vaccines hurt and the
arm is frequently sore, so he was not overly concerned about petitioner’s complaints and “really
just brushed them off at that time.” Pet. Ex. 16 at 5. He stated they had “bigger things on [their]
plate,” and even though petitioner complained to him, he “really just pretty much blew her off, to
be honest.” Tr. 91-92.
According to Dr. McFadden, petitioner’s shoulder pain became “significantly worse”
within two weeks of receiving the vaccine. It was about that same time they were told their son
needed to be transferred to Hawaii. Dr. McFadden stated when they went to Hawaii, he noticed
that she started complaining more, she struggled with holding their son, and her shoulder affected
her ability to sleep. Tr. 93; Pet. Ex. 16 at 2. Dr. McFadden stated he thought petitioner’s complaints
were from overuse as a new mother, though their son only weighed ten pounds at the time. He was
“baffled as there was no trauma to explain the injury but figured she had strained a muscle
somehow.” Pet. Ex. 16 at 2. But the top priority was their son and he expected her shoulder would
heal as musculoskeletal injuries naturally do. Pet. Ex. 16 at 2. Dr. McFadden testified that he
ultimately was the one primarily carrying their son for the first three months of Patrick’s life. Tr.
93. Dr. McFadden affirmed when the symptoms and weakness did not improve, he became more
concerned, but being away from Okinawa, he knew she could not get a referral for therapy. Pet.
Ex. 16 at 2.
Dr. McFadden explained that about twenty-five percent of his practice deals with shoulder-
related injuries. The two biggest joint complaints he sees are knees and shoulders. Tr. 106.
However, “I have never read or heard about SIRVA in any setting aside from my Vaccine Leaders
Course in Okinawa when it was first brought to my attention that this may have been the source
of her pain. Had I been aware of the diagnosis previously I would have had her seek appropriate
care sooner.” Pet. Ex. 16 at 5. Dr. McFadden could not recall if he specifically examined her left
shoulder, though he “probably had her do certain motions.” Tr. 106, 111. He thought her pain was
rotator cuff tendinopathy, an overuse type of injury— “I just marked it up to one of those because
that’s the most common things we see.” Tr. 93-94; Pet. Ex. 16 at 2. However during testimony,
Dr. McFadden admitted his theory at the time was probably not the best because she did not pick
her son up much at the hospital—he always handed their son to her—and because she was not
going to the gym around the time of Patrick’s birth. Tr. 94. Dr. McFadden testified he told her the
treatment would be physical therapy and that they “decided to delay her getting care until we got
back to Okinawa.” Tr. 94. Dr. McFadden explained that getting care at Tripler in Hawaii would
have required them to change their care region officially, schedule a new primary care manager,
receive an evaluation, and potentially wait up to four weeks before receiving a referral. Tr. 95. He
testified “it just didn’t make sense to start that process” when they did not intend to be in Hawaii
for long, especially given that physical therapy is “something that you have to continue to do and
follow up and see the provider over and over.” Tr. 95-96. Dr. McFadden also explained that his
wife put off post-delivery care [following a C-section] as well, until nearly three months after
delivery. Tr. 97; Pet. Ex. 16 at 4. She did not receive care at any civilian or private facilities during
the time they were in Hawaii and Seattle. Pet. Ex. 16 at 4.
12
Dr. McFadden affirmed they returned to Okinawa in December of 2013. Petitioner was
visibly suffering from shoulder pain, altering her activities to avoid moving the arm, and putting
off going for medical care being a busy new mother. Tr. 96; Pet. Ex. 16 at 2. He testified that
petitioner did not seek shoulder care until March because she was very busy during that time period
and basically “chose to delay [care for her shoulder] until she knew she was going to have the time
to commit to doing the therapy properly.” Tr. 97. He testified that Patrick was able to stop using
the pulse oximeter and taking caffeine at around seven months, March/April, which gave petitioner
more available time. He added that they had just arrived in Okinawa in July 2013, shortly before
petitioner gave birth, and had not made any friends. “[B]y the time we’re in nine months in the
future… we were more acclimated to the island. We had more friends that we trusted to kind of
step in, and there was definitely a better opportunity.” 11 Id.
Dr. McFadden testified that at one point he took petitioner to see his physical therapist
colleague, John Hill. “He is drastically more qualified than your typical physical therapist, and I
trusted him more than just some random physical therapist at the hospital.” Tr. 99. John Hill
offered to and performed the Graston procedure for petitioner. Tr. 100.
Dr. McFadden testified that as the Officer In Charge of the medical clinic in Okinawa and
part of his official duties, he attended a three-day Immunization Leader’s Course on March 12-14,
2014 where he learned of SIRVA injuries. Tr. 101; Pet. Ex. 16 at 3. After the presentation, he
spoke to the presenter who worked with the Armed Forces Immunization Healthcare Center in
Virginia. The presenter encouraged him to have petitioner call her and gave him her card. Tr. 102;
Pet. Ex. 16. at 3. Dr. McFadden stated he did not explain SIRVA to petitioner when he returned
but suggested that the vaccine may have caused her shoulder pain and asked her to call the
presenter, Jeanette Williams. Tr. 103. He stated the booklet they received at the seminar did not
specifically discuss SIRVA. Tr.103. During their next trip back to Northern Virginia, petitioner
followed up with the Immunization Center, was evaluated there, and was diagnosed with SIRVA.
Pet. Ex. 16 at 3. According to Dr. McFadden, an MRI of petitioner’s shoulder showed a rotator
cuff tear. Pet. Ex. 16 at 3.
According to Dr. McFadden, petitioner completed a formal course of PT at the hospital,
and “worked off the books with a physical therapist” from Dr. McFadden’s clinic “another dozen
times in an attempt to stabilize the shoulder and improve her pain.” Pet. Ex. 16 at 3. Dr. McFadden
confirmed that the physical therapist he was referring to was his colleague, John Hill. Petitioner
would occasionally visit John Hill when she and Patrick brought Dr. McFadden lunch. Tr. 99. Dr.
McFadden also testified that he “had her check in with John Hill from time to time to see if there
were any additional exercises that he recommended or anything that she should be adding.” Tr.
104. He stated that petitioner is diligent in performing her shoulder exercises but still suffers daily
pain, needs to modify her activities, and has difficulty swimming which really bothers her. He
must bear “the brunt of” carrying their son who was now over 40 pounds. Pet. Ex. 16 at 3.
Dr. McFadden explained the process in which the military administers mass vaccination
for maximal effect adding that the documents are not uploaded in the same fashion as childhood
vaccinations or other vaccines that are given year-round. Petitioner received her flu vaccine during
one of these periods. Tr. 89-90; Pet. Ex. 16 at 3-4.
11
Nine months after July 2013 would be March 2014.
13
Dr. McFadden also explained that petitioner did not receive any post-delivery care for three
months due to their son being their priority. Being a physician who performs post-obstetrics
examinations for his patients, he was capable of checking her C-section wound and providing
general post-partum care without the “hassle” of changing her Tricare region, “just so she could
have a routine post-partum visit…a huge hassle for minimal benefit.” Tr. 97; Pet. Ex. 16 at 4.
Dr. McFadden reviewed the Vaccine Health records to answer questions for his affidavit.
He confirmed he was with his family the entire duration of the medevac. Pet. Ex . 16 at 5. As far
as a timeline of events, he recalls her complaint immediately after the vaccine , significant pain
throughout the rest of that day and several days thereafter. He recalled that she again complained
regularly of her shoulder pain around the time their son was discharged from the hospital. Tr. 91;
Pet. Ex. 16 at 6. Even though petitioner complained to him about her shoulder and he noticed her
grimace when holding their son, he admitted that he was not supportive of her seeking care for her
shoulder. See Tr. 91-92. At the hearing, Dr. McFadden admitted to blowing petitioner off, telling
her that they could not deal with her shoulder pain. Id.
III. DISCUSSION
A. Applicable Legal Standard
Petitioner bears the burden of establishing her claims by a preponderance of the evidence.
§ 13(a)(1). A petitioner must offer evidence that leads the “trier of fact to believe that the existence
of a fact is more probable than its nonexistence before [he or she] may find in favor of the party
who has the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted).
The process for making determinations in Vaccine Program cases regarding factual issues,
such as the timing of onset of petitioner’s alleged injury, begins with analyzing the medical
records, which are required to be filed with the petition. § 11(c)(2). Medical records created
contemporaneously with the events they describe are presumed to be accurate and “complete” such
that they present all relevant information on a patient’s health problems. Cucuras v. Sec’y of Health
& Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). This presumption is based on the linked
proposition that (i) sick people visit medical professionals; (ii) sick people honestly report their
health problems to those professionals; and (iii) medical professionals record what they are told or
observe when examining their patients in an accurate manner, so that they are aware of enough
relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health & Human Servs.,
No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec’y of
Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F. 2d. 1525 (Fed. Cir. 1993) (“[i]t
strains reason to conclude that petitioners would fail to accurately report the onset of their
daughter’s symptoms. It is equally unlikely that pediatric neurologists, who are trained in taking
medical histories concerning the onset of neurologically significant symptoms, would consistently
but erroneously report the onset of seizures a week after they in fact occurred”). In making
contemporaneous reports, “accuracy has an extra premium” given that the “proper treatm ent
hang[s] in the balance.” Id. A patient’s motivation for providing an accurate recount of symptoms
is more immediate, as opposed to testimony offered after the events in question, which is
14
considered inherently less reliable. Reusser v. Sec’y of Health & Human Servs., 28 Fed. Cl. 516,
523 (1993); see Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968
F.2d 1226 (Fed. Cir. 1992) (citing United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1948)).
Contemporaneous medical records that are clear, consistent, and complete warrant substantial
weight “as trustworthy evidence.” Cucuras, 993 F.2d at 1528. Indeed, “where later testimony
conflicts with earlier contemporaneous documents, courts generally give the contemporaneous
documentation more weight.” Id.
However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as in cases where records are deemed to be incomplete or inaccurate.
See Campbell ex rel. Campbell v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006)
(“[L]ike any norm based upon common sense and experience, this rule should not be treated as an
absolute and must yield where the factual predicates for its application are weak or lacking.”). The
Court of Federal Claims has listed four possible explanations for inconsistencies between
contemporaneously created medical records and later testimony: (1) a person’s failure to recount
to the medical professional everything that happened during the relevant time period; (2) the
medical professional’s failure to document everything reported to her or him; (3) a person’s faulty
recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of
symptoms that did not exist. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-
04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). Ultimately, a determination regarding a witness’s
credibility is needed when determining the weight that such testimony should be given. Andreu v.
Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health
& Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is used to overcome the presumption of accuracy given to
contemporaneous medical records, such testimony must be “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) (quoting Blutstein v. Sec’y of Health & Human Servs., No.
90-2808V, 1998 WL 408611, at *85 (Fed. Cl. Spec. Mstr. June 30, 1998)); see, e.g., Stevenson ex
rel. Stevenson v. Sec’y of Health & Human Servs., No. 90-2127V, 1994 WL 808592, at *7 (Fed.
Cl. Spec. Mstr. June 27, 1994) (crediting the testimony of a fact witness whose “memory was
sound” and “recollections were consistent with the other factual evidence”). Moreover, despite the
weight afforded medical records, special masters are not bound rigidly by those records in
determining onset of a petitioner’s symptoms. Vallenzuela v. Sec’y of Health & Human Servs., No.
90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see also Eng v. Sec’y of
Health & Human Servs., No. 90-175V, 1994 WL 67704, at *3 (Fed. Cl. Spec. Mstr. Feb 18, 1994)
(explaining that § 13(b)(2) “must be construed so as to give effect to § 13(b)(1) which directs the
special master or court to consider the medical record...but does not require the special master or
court to be bound by them”). Special Masters may find onset within the time period described in
the Vaccine Injury Table even if the occurrence of such symptom or manifestation was not
recorded or was incorrectly recorded as having occurred outside such period. § 13(b)(2). In short,
all relevant evidence on the record must be considered. See § 13(b).
B. Evaluation of the Evidence
A vaccine recipient shall be considered to have suffered SIRVA if such recipient
manifests all the following:
15
(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 [within 48 hours of vaccine
administration];
(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).
The issue to be determined here is the onset of petitioner’s alleged SIRVA injury as a result
of a flu vaccine she received on September 28, 2013. The records document reports of onset as
September 28, 2013, October 3, 2013, and sometime in October of 2013. See Pet. Ex. 9 at 226,
229, 245, 251. Petitioner and her husband testified at the onset hearing but were sequestered during
each other’s testimony. Scheduling Order at 1, ECF No. 49.
a. Credibility of Petitioner’s Testimony
For petitioner’s testimony to overcome the presumption that contemporaneous records are
complete and accurate, petitioner’s testimony must be “consistent, clear, cogent, and compelling.”
See Sanchez, No. 11-685V, 2013 WL 1880825, at *3. A determination of a petitioner’s credibility
must be made in assigning weight to petitioner’s testimony. See Andreu, 569 F.3d at1379. Here, I
found the petitioner to be credible and her testimony compelling, consistent and of sufficient
weight to overcome the presumption of accuracy afforded contemporaneous medical records. Her
testimony of the events surrounding her receipt of the flu vaccine and over the next six months
were further bolstered by her husband’s testimony.
Petitioner’s credibility is found in her reasonable and consistent explanations as to why she
did not seek medical care for her left shoulder pain until March of 2014 and why she did not report
left shoulder pain during her contacts with medical providers between her vaccination and March
of 2014.
Petitioner reasonably explained why she did not seek immediate care for her shoulder pain
between vaccination and October 10, 2013, when they were transferred from Japan to Hawaii.
During this period, petitioner was recovering from her C-section, her son was in the NICU, she
was breast-feeding on demand, and physicians did not know what was causing her son’s breathing
problems. Tr. 8, 11. She explained “she was not the patient of concern.” Tr. 12; Pet. Ex. 15 at 1.
“I was living and breathing what was going on with my son because at that point we didn’t know
was going on, and you don’t expect when you’re a first-time mom to have any of that happen.” Tr.
13. She admitted due to the stress of her son’s condition, “I was kind of falling apart…” Tr. 16.
16
Her affidavit and testimony are further supported by her husband’s testimony. Recalling his wife’s
immediate complaints after the vaccination, he admittedly “blew it off” and “didn’t make much of
it.” Tr. 91. He testified they “had bigger things on [their] plate,” referring to their newborn son’s
condition. Id. Despite petitioner’s continued complaints to him about her shoulder pain and having
noticed her grimaces when holding their son, he admitted that he was not supportive of her seeking
care for her shoulder. See Tr. 91-92. He testified:
“I feel guilty about it now… I tended to downplay my wife’s conditions and tell her, you
know, you had an immunization, it’s supposed to be sore, let’s focus on what’s going on
here. We don’t need something else to worry about right now. And, so, I just pretty much
blew her off, to be honest.” Tr. 91-92.
Further, petitioner explained her limited contact with her care providers during the time
her son was being treated in Hawaii and Seattle. Petitioner testified about their stay in Hawaii, the
horrible conditions in which they had to live, and her being “in newborn mom mode, sleep-
deprived” and worried about her son’s condition. Tr. 37-40. They did not know how long they
would be Hawaii or that they would ultimately be transferred to Seattle. Tr. 39. She relied on her
husband, who has sports medicine experience, when he told her that treatment for her left shoulder
pain would most likely be physical therapy. Tr. 40. Petitioner explained that transferring their
medical care coverage would be difficult and she was not looking to start physical therapy in a
temporary location. See Tr. 40. Dr. McFadden’s testimony corroborated petitioner’s statements.
He recalled telling petitioner she would need physical therapy to treat her shoulder pain so they
“decided to delay her getting care until we got back to Okinawa.” Tr. 94. He explained that getting
care transferred could take up to six weeks and since they did not anticipate being in Hawaii that
long, “it just didn’t make sense to start that process.” Tr. 96. Consistent with this reasoning,
petitioner even postponed her post-caesarian obstetrical care throughout the entire period they
were away from Japan. Tr. 97.
The contacts petitioner did have with her medical providers between the date of vaccination
and March of 2014 were all for concerns petitioner felt were more urgent or severe. On October
23, 2019, petitioner made a phone call requesting a punch biopsy of a spot on her upper left
shoulder; she went for the biopsy on January 3, 2014. Pet. Ex. 9 at 271, 277-78. Petitioner affirmed
being very vigilant with her skin care because she was fair. Pet. Ex. 15 at 2. Though still primarily
concerned with her son, she was worried about possible skin cancer having been previously warned
by dermatologists that she may develop skin cancer by the time she turned thirty. Tr. 36. At the
end of 2013, petitioner was twenty-five. It is understandable, particularly for a new mother, why
the prospect of skin cancer may be alarming, or “more pressing” than a musculoskeletal issue. Tr.
22. Additionally, the skin spot had been pointed out to her by her mother, who previously had
skin cancer removed. Id. The gravity of her concern was in the fact borne out by this being the first
medical visit she attended upon returning to Japan. She addressed her genitourinary appointment
on January 8, 2014, testifying that her vaginal pain, which was documented at a pain level of
“8/10” was “not something that you’re going to want to put off.” Tr. 53; Pet. Ex. 9 at 255, 267.
Petitioner also testified to her ulcerative proctitis appointment on January 16, 2014 explaining that
though asymptomatic, she was very careful about her chronic gastrointestinal condition because
her mother-in-law passed away from colon cancer. Tr. 54. Having not had any medical care since
the birth of her son in September of 2013, it was understandable why petitioner presented for her
17
most serious concerns in January upon her return to Japan. Further, addressing these more pressing
concerns was reasonable, particularly in light of her husband, a physician who routinely treated
shoulder injuries, assuring her that she would be fine but would likely need physical therapy which
was something she could not commit to at the time.
The records contain no report of shoulder pain to any medical provider between her
vaccination and March of 2014. Petitioner did not mention left shoulder pain during her October
29, 2013 phone call requesting a biopsy. Pet. Ex. 9 at 277-78. She reported “0 out of 10” pain
during her January 3, 2014 biopsy appointment. Id. at 271. She did not mention left shoulder pain
at her January 8, 2014 primary care consult for dyspareunia, or her January 16, 2014
gastrointestinal (“GI”) appointment for ulcerative proctitis, or her January 17 dermatology
appointment, or at her January 30, 2014 gynecology appointment for dyspareunia. See Pet. Ex. 9
at 256-272.
However, at hearing, petitioner did not attempt to change or challenge the record but rather
provided cogent explanations for why she did not mention left shoulder during these medical
contacts. Petitioner explained how the military medical system works—an appointment is made to
address a specific concern and one does not mention multiple or unrelated concerns at one
appointment. Tr. 22, 51. “Our appointments are 20 minutes long, and the physician or the
physician’s assistant isn’t going to address multiple issues at one time. That’s not how it works.”
Tr. 22. Petitioner specifically addressed the appointments she attended. She testified that her visit
to the dermatologist was for a concerning spot on her left shoulder located closer to her neck and
not in the same location as her left shoulder pain; as they were not related, she would not have
mentioned her shoulder pain to dermatology. Tr. 22. Petitioner further testified that she likely
reported 0 out of 10 pain on January 3, 2014 related to the spot to be biopsied—there was no pain
at that location of the concerning spot. Tr. 51. Petitioner agreed that the record for her GI
appointment recorded no musculoskeletal complaints, but again explained that an appointment is
for a single issue; she would not tell her GI doctor about a musculoskeletal issue. Tr. 55. Petitioner
also explained that the doctors do not necessarily check for all the symptoms; only the one you are
there for and simply report no other symptoms. Tr. 74. Petitioner similarly testified that she only
reported the pain associated with her dyspareunia at her appointments for dyspareunia. Tr. 52.
Lending credibility to petitioner’s testimony is that the separate appointment records do not
reference each other. Each record references the complaint for which petitioner presented but does
not contain any other complaint for medical problems during that time. For example, petitioner’s
visit for dyspareunia does not reference a recent visit for a skin biopsy or ulcerative proctitis, even
though these appointments all took place within the same timeframe. See Pet. Ex. 9 at 265-273.
The absence of cross-referencing lends credibility to petitioner’s testimony that only a singular
issue is addressed at each appointment. See Tr. 22, 55. Petitioner’s actions were consistent with
her testimony: “I had been told repeatedly by my husband and as a provider myself that you address
what you’re there for and you don’t just bring everything up because you have a 20 -minute
appointment.” Tr. 51.
Lastly, petitioner’s testimony was clear and consistent with her husband’s more detailed
testimony as to why she did not report or officially seek care for her shoulder until March of 2014.
Petitioner believed her shoulder pain would potentially resolve on its own, she was focused on her
son, she had little ability to leave her son, and she was told by her husband that treatment would
18
be physical therapy. Tr. 19, 40, 58, 96; Pet. Ex. 15 at 2-3. After returning to Japan, petitioner’s
continued focus was her son, who needed constant sleep monitoring and caffeine. She did not have
help in caring for him and had yet to find a babysitter she trusted to leave her son with. Tr. 19; Pet.
Ex. 15. “I wasn’t just able to leave him. I typically can bring him to appointments, like if it’s a 20
minute-appointment, but for physical therapy, you can’t bring your child with you.” Tr. 19, 58.
Petitioner tried to tough out her shoulder pain, testifying, “I was compensating for [my shoulder
pain], and it was something that I honestly thought was going to go away .” Tr. 58. “I had not
previously experienced musculoskeletal injuries in my life and naively expected the ongoing pain
to simply disappear.” Pet. Ex. 15 at 3. It was not until simple tasks such as closing the car door or
“things like lifting up an iPad, which is pretty light” caused unbearable pain that petitioner
officially sought care in March of 2014. Tr. 21.
Dr. McFadden’s testimony was particularly compelling as to why petitioner did not seek
treatment until March of 2014. In addition to having brushed off petitioner’s complaints, having
told her that they could not deal with her shoulder while their son needed intensive care, as well
as advising petitioner she would need consistent physical therapy , Dr. McFadden was largely
unavailable once they returned to Japan. Dr. McFadden testified that upon their return, he worked
14-hour days and frequently traveled. He was deployed to Korea, then Australia, New Zealand,
back to Korea, Malaysia, the Philippines, the States—his schedule was just “absolute chaos.” Tr.
98-99. While he was working and traveling, the petitioner was very busy. She altered her activities
to avoid moving the arm and put off going for medical care as a busy new mother does. Tr. 96;
Pet. Ex. 16 at 2. Dr. McFadden further testified that Patrick needed the pulse oximeter and caffeine
until he was around seven months old. It was not until then that petitioner had more available time
to take care of herself. Tr. 97-98. Having just arrived in Okinawa shortly before petitioner gave
birth and not having made any friends or found a babysitter, petitioner also had no one she trusted
to leave her son with until March/April of 2014. By that time, petitioner and her husband “had
more friends that [they] trusted to kind of step in, and there was definitely a better opportunity.”
See Tr. 98. This was when petitioner finally sought care and attended physical therapy.
Overall, petitioner was a credible witness. She provided reasonable and consistent
explanations as to why she did not seek medical care for her left shoulder pain until March of 2014
and why she did not report left shoulder pain during her contacts with medical providers between
her vaccination and March of 2014. While the various dates of onset reported by petitioner is
troubling at first blush, it is understandable how the timeframe from the birth of petitioner’s son
by C-section and the months that followed became a blur of days, weeks and months with no
concept of time and no understanding of the import for exact reporting of onset. Furthermore, her
testimony was corroborated by her husband’s, as well as by medical records that aligned with her
purported understanding and actions. I find petitioner credible and her testimony appropriate for
use in determination of petitioner’s shoulder pain onset.
b. Determination of Onset
So long as there is preponderant evidence, Special Masters may find onset within the time
period described in the Vaccine Injury Table even if the occurrence of such symptom or
manifestation was not recorded or was incorrectly recorded as having occurred outside such
period. § 13(b)(2). In reviewing the record as a whole and affording significant weight to the
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testimony of the petitioner and Dr. McFadden, I find that there is preponderant evidence to support
the onset of petitioner’s left shoulder pain within 24 hours of her September 28, 2013 flu
vaccination.
Petitioner consistently associated her shoulder pain to the vaccination. While petitioner’s
medical record includes onset times that vary to some degree, they are generally consistent with
her testimony that her shoulder pain began at the same time as her vaccination. On March 7, 2014,
petitioner reported a four-month history of left arm pain, “possibly due to picking up her newborn
child so much.” Pet. Ex. 9 at 251-53. Petitioner explained she provided “a ballpark, you know, it’s
been hurting four or five months because I knew that it had been hurting since around the time that
Patrick had been born. But I’m not sitting there holding a calendar and saying, okay, my shoulder
started hurting on this day.” Tr. 23-24.
Petitioner further testified that the March 7th record was wrong in documenting that she
had no pain at that visit. She explained that the doctor was not writing at the same time she was
speaking, and if she was not experiencing pain, she would not have pursued physical therapy,
which is what she was seeking referral for. Tr. 49. Given that the record notes petitioner was there
for shoulder pain with severity of four out of ten, yet also notes that petitioner was pain free at this
visit, confirms the record is internally inconsistent. See Pet. Ex. 9 at 251. As such, I accord this
record less deference and find petitioner’s testimony more convincing and clarifying. See Lowrie,
2005 WL 6117475, at *19 (“Written records which are, themselves, inconsistent, should be
accorded less deference than those which are internally consistent.” (quoting Murphy, 23 Cl. Ct.
at 733)). On March 18, 2014, petitioner presented for PT evaluation and reported a five -month
history of left arm pain. Pet. Ex. 9 at 245. Petitioner similarly testified that she gave an estimate
during her March 18, 2014 visit, “[S]he asked me when the pain had started, and I said, you know,
around the time that Patrick was born. At that point, I wasn’t giving, you know specifics because
I was just saying, you know, this is how long my shoulder’s been hurting in general.” Tr. 23. While
these two March 2014 records are more general than petitioner’s ultimate assertion of onset,
petitioner’s testimony of estimates is consistent, and her estimate of five months place her onset
of pain around the time of the vaccination. Furthermore, considering all that petitioner was dealing
with during this period, she reasonably did not recount every detail she experienced during the
stressful period after her son was born. Petitioner’s first reports of shoulder pain while seeking
treatment placed onset of pain around the time of the vaccination.
Petitioner also testified that she reported, during her April 2014 appointments, immediate
pain upon vaccination which peaked in five days. On her April 4, 2014 phone call with Jeanette
Williams from the Vaccine Health Center, petitioner reported that she received the flu vaccine on
October 5, 2013, which is incorrect, and had pain about five days after vaccination which has
continued with certain movements. Pet. Ex. 9 at 229. Petitioner testified that she did not have her
records in front of her during this phone call and believed her vaccination was on a Saturday after
her son’s birth, which is why she mistakenly provided October 5, 2013 as the vaccination date. Tr.
78. Petitioner also explained the five days after vaccination to mean “there was a peak at five days”
of pain after the vaccination. While the April 4, 2014 call was the first-time petitioner provided
information as to onset of her pain, petitioner explained “[t]hose details most likely came from
Jeannette because she was asking me a series of questions about my vaccine.” Tr. 76. Petitioner
testified that she specifically recalled how the vaccine was administered because she had asked the
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corpsman if she could sit down after standing up for a while and, having just had a C-section, was
uncomfortable. Tr. 10, 79. On April 30, 2014, petitioner attended an appointment with Dr.
Montgomery. The medical records from her visit with Dr. Montgomery were consistent with what
petitioner was explaining when it noted that petitioner received the flu vaccine high and anterior
on her deltoid, her shoulder pain began within 24 hours, and her pain reached a peak within five
days. Pet. Ex. 9 at 226. While petitioner may have learned of SIRVA at this point, petitioner’s
testimony was candid and added credibility to the April 30, 2014 records. Petitioner stated:
“[Dr. Montgomery] began asking me questions about my vaccine, and I recounted to him
when the pain began and how painful the actual vaccine administration was, you know,
and sitting down and telling my husband this was super painful. But e ven at that point, I
wasn’t reporting any vaccine injury or anything like that. I was just trying to figure
out why my shoulder was hurting. And I told Dr. Montgomery, I think my shoulder hurts
because my son was born and I was holding him a bunch. I didn’t go into that
appointment with any preconceived notions, or you know, I don’t go to the doctor to tell
them what my diagnosis is.”
Tr. 25-26. Based on petitioner’s reports and MRI examination, Dr. Montgomery diagnosed
petitioner with a SIRVA of the left shoulder. Pet. Ex. 3 at 1-2; Pet. Ex. 9 at 227.
Lastly, but not of least significance, petitioner’s testimony and documented reports of
immediate and ongoing shoulder pain following vaccination were corroborated by petitioner’s
husband. Dr. McFadden testified, “I distinctly remember her telling me that that was the most
painful immunization shot that’s she’s ever received in her entire life. And that’s a direct quote.”
Tr. 90. He affirmed she immediately complained to him about the “most painful vaccine she had
ever had in her entire life” and continued to complain over the next several days. Tr. 91-92, 102.
Dr. McFadden recalled petitioner saying, “God, my shoulder really hurts, this is really sore,” and
that he saw her grimace with pain. Tr. 92. He admitted that despite her complaints, he brushed her
off because he was more concerned about their son’s breathing problem, “I feel guilty about it
now… I really just pretty much blew her off, to be honest.” Tr. 91-92. His testimony largely
corroborated petitioner’s testimony, even though it may have been difficult for him to admit that
he minimized his wife’s pain and had been upset with her shoulder complaints at the time in light
of what they were dealing with. See Tr. 91-92. Petitioner’s testimony of immediate and ongoing
shoulder pain after vaccination is supported by her husband’s candid testimony.
The six-month gap between petitioner’s vaccination and first report of shoulder pain, as
well as the inconsistencies in the record, are remedied by petitioner’s consistent and corroborated
testimony of immediate onset of shoulder pain. Petitioner was particularly compelling considering
the challenging circumstances in petitioner’s life surrounding the time of her vaccination.
Petitioner was a first-time mother and had arrived in Okinawa just two months prior to the birth of
her son, who upon his arrival needed emergency medical care including being sent by medevac to
Hawaii then Seattle. Petitioner could not simply seek medical care during her son’s treatment while
outside of her husband’s assigned military base. Dr. McFadden was not initially supportive of her
complaints of shoulder pain or of her seeking care, reminding her that their focus was on taking
care of their son. Petitioner ultimately sought care for her shoulder when she could no longer
withstand the pain and had the time to take care of herself. She provided estimations when first
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reporting her history of shoulder pain, but when asked detailed questions, provided more detailed
answers. The inconsistences that exist in the record are largely because petitioner could not account
for time and details during this stressful six-to-seven-month period after her son was born—days
and weeks were a blur and memories would be unclear due to exhaustion. Petitioner’s corroborated
testimony, aligned with the contemporaneous records and her explanations for their content,
establish that the onset of her shoulder pain within 24 hours of her vaccination.
IV. CONCLUSION
Upon detailed review of the record in its entirety and for all the foregoing reasons, I find
that petitioner’s onset of shoulder pain began within 24 hours of her September 28, 2013 flu
vaccination.
Within thirty (30) days, petitioner shall review this Ruling and file a status report advising
how she wishes to proceed. Petitioner may submit a demand to respondent for settlement or
proceed with her claim.
Accordingly, the following is ORDERED:
By no later than Wednesday, February 10, 2021, petitioner shall file a status report
advising whether she intends to submit a demand to respondent or proceed with her
claim.
IT IS SO ORDERED.
s/Mindy Michaels Roth
Mindy Michaels Roth
Special Master
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