denying review of the special master’s determination that the petitioners did not present independent evidence supporting that their daughter experienced seizures
How later courts described this case
- denying review of the special master’s determination that the petitioners did not present independent evidence supporting that their daughter experienced seizures
Written by the judges who cited it.
The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: August 20, 2020
* * * * * * * * * * * * *
RUTH GEAR, * UNPUBLISHED
*
Petitioner, * No. 18-1684V
*
v. * Special Master Gowen
*
SECRETARY OF HEALTH * Finding of Fact; Tetanus-Diphtheria-
AND HUMAN SERVICES, * Acellular Pertussis (Tdap); Shoulder
* Injury Related to Vaccine
Respondent. * Administration (SIRVA); Onset.
* * * * * * * * * * * * *
Jeffrey S. Pop & Kristina Grigorian, Jeffrey S. Pop & Associates, Beverly Hills, CA, for
petitioner.
Camille C. Collett, United States Department of Justice, Washington, DC, for respondent.
FINDINGS OF FACT1
On October 31, 2018, Ruth Gear (“petitioner”), filed a petitioner for compensation under
the National Vaccine Injury Compensation Program.2 Petitioner alleges that as a result of
receiving an tetanus-diptheria-acellular pertussis (Tdap) vaccination on November 13, 2015, she
suffered a right shoulder injury related to vaccine administration (“SIRVA”) with onset of pain
within forty-eight (48) hours, constituting an injury listed on the Vaccine Injury Table. Petition
(ECF No. 1). For the reasons discussed below, I find that the onset of petitioner’s shoulder pain
began within 48 hours of vaccination.3
1
Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this decision contains a
reasoned explanation for the action in this case, I am required to post it on the website of the United States Court of
Federal Claims. The court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. This means the
decision will be available to anyone with access to the Internet. Before the decision is posted on the court’s
website, each party has 14 days to file a motion requesting 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). “An objecting party must provide the court with a proposed redacted version of the
decision.” Id. If neither party files a motion for redaction within 14 days, the decision will be posted on the
court’s website without any changes. Id.
2
The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended 42 U.S.C. §§ 300aa-10 to 34 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.
3
Pursuant to §300aa-13(a)(1), in order to reach my conclusion, I considered the entire record. This opinion
I. Procedural History
After timely filing the petition, on November 30, 2018, petitioner filed her medical
records and several supporting affidavits. Petitioner’s Exhibits (Pet. Exs.) 1-20.
On October 7, 2019, respondent filed a status report advising that the record appeared to
be complete. Respondent’s (Resp.) Status Report (ECF No. 19). On November 5, 2019,
respondent filed his report pursuant to Rule 4(c). Resp. Report (ECF No. 21). Respondent
recommended that compensation be denied, for which his only argument was that “the
contemporaneous medical records do not support the onset of pain within forty-eight hours of
vaccination.” Id. at 8. Petitioner subsequently filed additional affidavits and other materials in
support of her claim. Pet. Exs. 20-22.
On April 22, 2020, I convened a status conference to set further proceedings to resolve
the onset issue. I discussed that the COVID-19 crisis complicated the logisitics of a fact hearing
but that option remained available. Scheduling Order entered April 23, 2020 (ECF No. 28).
Respondent deferred to my decision about which further proceedings should be set. Resp. Status
Report filed April 30, 2020 (ECF No. 29). Petitioner requested a finding of fact on the record
subsequent to the parties’ filing of briefs. Pet. Status Report filed April 30, 2020 (ECF No. 30).
I granted petitioner’s request. Scheduling Order filed May 5, 2020 (ECF No. 31).
On June 18, 2020, petitioner filed a motion for a ruling on the record regarding onset.
Pet. Motion (Mot.) (ECF No. 32). On July 20, 2020, respondent filed a response. Resp.
Response (ECF No. 33). On August 6, 2020, petitioner filed a reply. Pet. Reply (ECF No. 34).
This matter is now ripe for a finding of fact regarding onset.
II. Legal Standard
Petitioner bears the burden of establishing the facts necessary for entitlement to an award
by a “preponderance of the evidence.” § 300aa-12(a)(1)(A). The special master “may not make
such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by
medical opinion.” § 300aa-13(a)(1).
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records, which are required to be filed with the petition.
§11(c)(2). The Federal Circuit has made clear that medical records “warrant consideration as
trustworthy evidence.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d at 1528. Medical
records that are created contemporaneously with the events they describe are presumed to be
accurate and “complete” (i.e., presenting all relevant information on a patient’s health problems).
Cucuras, 993 F.2d at 1528.
Accordingly, where medical records are clear, consistent, and complete, they should be
afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule does not always
discusses the elements of the record I found most relevant to the outcome.
2
apply. In Lowrie, the special master wrote that “written records which are, themselves,
inconsistent, should be accorded less deference than those which are internally consistent.”
Lowrie, at *19.
The Court of Federal Claims has recognized that “medical records may be incomplete or
inaccurate.” Camery, 42 Fed. Cl. at 391. The Court later outlined 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 1335 (Fed. Cir. 2014).
The Court has also said that medical records may be outweighed by testimony that is
given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42 Fed. Cl. at 391
(citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed.
Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such testimony must
also be determined. 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).
The special master is obligated to fully consider and compare the medical records,
testimony, and all other “relevant and reliable evidence contained in the record.” La Londe, 110
Fed. Cl. at 204 (citing § 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health & Human
Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special master’s discretion
to determine whether to afford greater weight to medical records or to other evidence, such as
oral testimony surrounding the events in question that was given at a later date, provided that
such determination is rational).
III. The Factual Record
A. Medical Records
1. Before Vaccination
At the relevant time, petitioner was 54 years old and right hand dominant. She received
regular medical care through the Unity Point Health System in Iowa. Her primary care provider
was Carin A. Bejarno, ARNP. Petitioner’s medical history did not include pain, limited range of
motion, or trauma in the right shoulder. It did include other medical concerns including
hypertension, hyperlipidemia, morbid obesity, and type II diabetes. See generally Pet. Ex. 3.
Petitioner also had a history of depression and family stressors. In December 2013, she
presented to the primary care practice, where she “became tearful in the waiting room.” Pet. Ex.
14 at 23. Anna Acheson, CMA, took petitioner into a room to privately discuss concerns.
Petitioner stated that “overwhelmed with taking care of her daughter, mother, and father, and
working NICU” and “she is constantly taking care of others”. Petitioner reported that she had
been taking Lexapro without dosage changes for a long time. CMA Acheson encouraged
3
petitioner to talk about these issues in her medical appointments, consider seeing a counselor,
and “make time for herself and make sure she is caring mentally as well”. Pet. Ex. 14 at 23.
After this discussion, petitioner was seen by NP Bejarno for a fasting medication check related to
her diabetes. The appointment records do not mention her mental health. Pet. Ex. 14 at 24-27.
As of November 2014, petitioner was taking Lexapro 20 mg. Pet. Ex. 3 at 8. At the next
appointment on April 14, 2015, NP Bejarno recorded again that petitioner was dealing with
significant stress involved with caring for her numerous family members. Pet. Ex. 3 at 2. NP
Bejarno increased the Lexapro prescription to 30 mg daily. Id. at 6.
On July 24, 2015, NP Bejarno recorded again that petitioner was dealing with increased
depressed mood and fatigue related to her mother passing away in April 2015 and her continued
responsibilities caring for her elderly father and daughter, as well as her full time job. Petitioner
continued to take Lexapro. She was not doing counseling or any regular exercise. Pet. Ex. 3 at
16. A review of systems was normal including “Musculoskeletal: No cyanosis, clubbing, or
edema.” Id. at 18. NP Bejarno recommended counseling and potentially augmenting Lexapro
with other medications. Id. at 19.
2. After Vaccination
On November 13, 2015, petitioner returned to NP Bejarno for a fasting medication check
related to her diabetes. This record does not record depression or personal stressors, but did
record fatigue. NP Bejarno set forth a plan for managing petitioner’s hypertension,
hyperlipidemia, diabetes, and obesity. A review of systems was normal including
“Musculoskeletal: No cyanosis, clubbing, or edema.” She received a tetanus-diphtheria-acellular
pertussis (Tdap) vaccination. The site of vaccine administration is not documented. Pet. Ex. 3 at
24-29; also at Pet. Ex. 2 at 4-8, Pet. Ex. 23.4
The next medical record is from January 25, 2016, when petitioner had a bone density
exam and a mammogram at Unity Point Health Radiology. She did not see a doctor, only a
technician. Pet. Ex. 3 at 57-60.
On March 4, 2016, petitioner returned to the primary care practice for another fasting
medication check. However, NP Bejarno recorded that petitioner had been “feeling more down”
ever since her mother’s death in April 2015, and also because of caring for her other family
4
In the Rule 4(c) report, respondent averred: “The occurrence of vaccination was documented in the records but
there is no administration of vaccination record provided. Respondent requests petitioner inquire whether a vaccine
administration record is available and, if so, that it be filed into the record.” Resp. Report at n. 2. Respondent
renewed this request in his brief regarding a ruling on the record. In response, petitioner’s counsel requested that the
medical provider produce “any and all vaccine administration records, vaccination consent forms, or any other
medical records related to the administration of Tdap vaccination on 11/13/2015.” Petitioner made this request on
December 12, 2019, recalls emailing the records to respondent’s counsel on April 22, 2020, and filed the records on
August 6, 2020 as Pet. Ex. 23. In her brief petitioner correctly notes that the records pertaining to vaccine
administration originally filed as Pet. Ex. 3 at 24-29 are substantially similar to the newly requested records filed as
Pet. Ex. 23 at 13, 19, 22-23, 27. It appears that petitioner has complied with respondent’s request to seek any record
of vaccine administration that would address the site of vaccine administration, but no such record exists.
4
members and the winter season. Pet. Ex. 3 at 30. Petitioner was still taking Lexapro and still wa
not doing counseling. Id. NP Bejarno added “depressive disorder” to the assessment and
referred to a counselor. Id. at 32, 34. This was in addition to discussing the plan to address
petitioner’s hyperintension, hyperlipidemia, hypertension, diabetes, and obesity. This record
repeats the notation: “Musculoskeletal: No cyanosis, clubbing, or edema.” There is no mention
of the right shoulder. Pet. Ex. 3 at 29-34.
On March 12, 2016, petitioner presented to an urgent care location complaining of a 4-5
day history of cough, congestion, and sore throat, as well as 1 day of fever. She was diagnosed
with bronchitis and prescribed doxycycline. The review of systems provides: “Extremities: no
clubbing, cyanosis, or edema.” There is no mention of the right shoulder. Pet. Ex. 4 at 4-6.
On June 23, 2016, petitioner returned to NP Bejarno. The recorded purpose of the
appointment was another fasting medication check. However, NP Bejarno recorded that
petitioner’s mood was improved in association with continued treatment with Lexapro, seeing a
counselor, and exercising regularly. NP Bejarno also recorded: “She does have concerns with
right shoulder pain. She reports that this is [sic] been a problem since last year. She reports that
when she had her tetanus shot in 2015, she feels like the immunization was given wrong. Since
that time, she has had intermittent pains in the right shoulder. She reports with certain
movements, especially reaching behind her back causes increased pain in the shoulder. She feels
like her range of motion is slightly limited due to tightness. She denies any known injury to the
shoulder.” Pet. Ex. 17 at 1. NP Bejarno conducted a more detailed musculoskeletal exam. She
recorded that petitioner’s abduction and adduction were slightly limited by pain in the anterior
aspect of the shoulder; internal and external rotation were limited by pain; and there was
ternderness over the anterior aspect of the shoulder joint with palpation. Id. at 4. A right
shoulder was unremarkable, Pet. Ex. 3 at 62-63. NP Bejarno added “shoulder pain” to the
assessment. Pet. Ex. 17 at 4. She recommended over-the-counter anti-inflammatory drugs,
avoiding heavy lifting, and physical therapy.
At the initial physical therapy appointment on July 11, 2016, the therapist recorded
petitioner’s account that she “Started having pain in Nov 2015 after getting a vaccine and pain
has not gone away, conr to irritate. TRed [sic? tried?] ice and Aleve but not any relief. Works in
NICU, holding babies hurt[s] as well as most movem[e]nts.” Pet. Ex. 6 at 1. The mechanism of
injury is recorded as “shot”. Id. The onset date is recorded as “11/11/2015”. Id.5 Petitioner’s
symptoms were found to be consistent with biceps tendonitis. Id. at 3. She was prescribed
skilled physical therapy twice a week for four weeks, with the goals of improving strength, range
of motion, and relief of pain. Id. at 4-6.
On July 19, 2016, on referral from her physical therapist, petitioner presented to an
orthopedic practice. Pet. Ex. 5 at 6. Brian Haupt, PA, recorded that petitioner had “concerns of
right shoulder pain that began about 6 months ago.” Id. “She apparently had a Tdap vaccination
at her family physician’s office. The injection was given where she felt was extremely high and
5
Petitioner avers in her onset brief: “Although Petitioner was off by (2) days in her estimate since Petitioner’s Tdap
vaccination was on 11/13/2015, it is clear that Petitioner was trying to explain that the date she got the vaccination
was the date of the onset of her shoulder pain.” Pet. Mot. at 9.
5
anterior in her shoulder. She points to the bicipital region of her shoulder. She had moderate
pain for about a 10-day period. It did improve to some degree but she continued to have
intermittent symptoms. It has continued to bother her throughout this time and now it is to the
point where it wakes her up at night. She will have some occasional numbness in the C6-7
distribution in the right upper extremity. She denies having any history of an abscess or other
masses that she can recall.” Id. PA Haupts’ assessment was long head bicipital tendonitis. Id. at
7. “Given the history of having an injection in this area and the chronicity”, he ordered an MRI
of the right shoulder before initating formal treatment. Id.
On July 20, 2016, petitioner returned to NP Bejarno to follow up on her right shoulder
pain and complete FMLA paperwork for her job as a nurse. NP Bejarno recorded: “She reports
that her shoulder pain has been a problem for the past 9 months. She reports that when she had
her tetanus shot in Nov 2015, she feels like the immunization was given wrong. Since that time
she has had intermittent pains in the right shoulder… She denies any known injury to the
shoulder.” Pet. Ex. 3 at 34. Id. On physical examination, there was tenderness with palpation to
the anterior aspect of the shoulder; strength at 4/5; and limited range of motion. NP Bejarno was
unable to fully assess the rotator cuff stability “due to the weakness with limited range of
motion.” Id. NP Bejarno prescribed diclofenac (Voltaren) and asked petitioner to forward the
report from the MRI once it occurred. Pet. Ex. 3 at 34-37; see also Pet. Ex. 22 at 1-4 (FMLA
paperwork signed by NP Bejarno).
On July 26, 2016, the MRI of the right shoulder revealed supraspinatus and infraspinatus
tendinopathy, posterior labrum tearing, and mild subacromial subdeltoid bursitis. Pet. Ex. 5 at 4.
On August 3, 2016, petitioner returned to the orthopedic practice, where she received a cortisone
injection. Pet. Ex. 5 at 1. It was noted that “if the injection is unsuccessful then referral to a
surgeon would be the next step.” Id. at 3.
On August 5, 2016, NP Bejarno recorded that the cortisone injection was associated with
improvement. NP Bejarno also reviewed the MRI findings of tendinopathy, a small posterior
labrum tear, and bursitis. She did not reference petitioner’s earlier accounts that the Tdap
vaccination was given wrong and caused the right shoulder symptoms. Pet. Ex. 3 at 38-40.
On August 8, 2016, the physical therapist recorded that petitioner’s pain was better
following the cortisone injection, but increased with certain movements. Pet. Ex. 6 at 7-8. She
continued physical therapy until October 25, 2016. Pet. Ex. 6 at 8-13; Pet. Ex. 7 at 1-11. On
October 31, 2016, NP Bejarno recorded petitioner’s continued right shoulder complaints and
filled out additional FMLA paperwork. Pet. Ex. 8 at 9-10; see also Pet. Ex. 22 at 5-8.
On November 8, 2016, petitioner presented to the orthopedic practice again, where she
was seen by Nicholas J. Honkamp, M.D. 6 He recorded that petitioner “was initially seen in the
6
Respondent notes Dr. Honkamp’s notation that petitioner “actually took care of our twins in the NICU.” Pet. Ex. 9
at 1. This does not seem relevant. Petitioner did not seek out Dr. Honkamp based on a personal relationship.
Instead, the physical therapist referred petitioner to the orthopedics practice, where she was first seen by several
physician assistants. When her symptoms continued and a cortisone injection was not associated with significant
improvement, her case was elevated to an orthopedist to consider surgery.
6
Urgent Injury Clinic on July 19 on referral from the physical therapist… [Petitioner] thinks she
had some pain that began with a Tdap vaccination at her family’s office about six months prior
to that.7 She began having worsening pain over her lateral arm with impingement type
symptoms.” Pet. Ex. 9 at 1. Dr. Honkamp also recorded that a subacromial steroid injection
carried out in August gave her “about 85% pain relief for about 4-5 weeks per her report and
then her pain came back.” Id. Dr. Honkamp’s assessment was right shoulder impingement. Id.
at 2. He recommended subacromial decompression, to which petitioner agreed. Id. at 3.
On November 28, 2016, petitioner underwent surgery by Dr. Honkamp, who performed
right shoulder arthroscopic subacromial debridement and decompression with minimal
debridement of rotator cuff, bursal side. Pet. Ex. 11 at 43-44. The post-operative diagnosis was:
“[r]ight shoulder subacromial impingement with mild bursal-sided rotator cuff tearing.” Id.
Petitioner attended regular post-surgical physical therapy sessions. On December 20,
2016, Dr. Honkamp recorded that she was having more stiffness, soreness, and decreased range
of motion following a physical therapy session. Dr. Honkamp discussed that the physical
therapy may be “stir[ring] up” some inflammation. He administered a steroid injection to the
right shoulder and had petitioner resume physical therapy the following week. Pet. Ex. 13 at 4-6.
On December 30, 2016, Dr. Honkamp authorized petitioner to return to work for 4 hours
per day until January 11, 2017, then to return without resrtiction. Pet. Ex. 13 at 3-4. On January
17, 2017, she was discharged from physical therapy with a home exercise program. Pet. Ex. 15
at 8-16. On January 24, 2017, Dr. Honkamp recorded that petitioner had resumed working 12-
hour shifts, which was associated with soreness, for which she applied ice. Petitioner also
reported that “when she is doing any repetitive exercises, she notices every once in a while some
clincking and popping.” Pet. Ex. 13 at 1. Dr. Honkamp recommended a home exercise program
to build up her muscles. Id. at 2.
On March 7, 2017, petitioner followed up with Dr. Honkamp, who recorded that her
condition was improved and that she was sleeping better. However, Dr. Honkamp recorded that
she had a lot of inflammation prior to surgery and that can lead to a slower recovery over all. Dr.
Honkamp emphasized that she needed to adhere to her home exercise program to maximize her
strength and overall results. Pet. Ex. 16 at 1-2.
B. Affidavits
1. Petitioner
In her affidavit filed November 30, 2018, petitioner Ruth Gear states that she has been
employed by Unity Point Health System in Iowa for 36 years as a registered nurse (RN). Pet.
Ex. 1 at ¶ 3. She has been working at Unity Point Health System – Blank Children’s Hospital in
the Neonatal Intensive Care Unit (NICU) for over 31 years. Id.
7
The primary care appointment and Tdap vaccination were actually on November 13, 2015, over eight months
before petitioner presented to the orthopedic practice on July 19, 2016. Regardless, Dr. Honkamp accurately
summarizes petitioner’s key contention: that the Tdap vaccination marked the start of her right shoulder symptoms.
7
Petitioner recalls that prior to the Tdap vaccination on November 13, 2015, she did not
have any history of pain, limited range of motion, or trauma to her right shoulder. Id. at ¶¶ 5-7,
9. Her mother passed away in June 2015. Id. at ¶ 8. At that point, she became a sole caretaker
for her father who lived across the street from her. Id. Petitioner recalls that she would “buy
groceries, cook meals for him, and make sure he takes his medications” until he passed away in
the summer of 2015. Id. During this same time period, she was also caring for her husband and
her adult daughter living at home, who each had their own health issues. Id.
Petitioner recalls that on November 13, 2015, she went to Unity Health Clinic family
medicine for a diabetic exam follow up. Id. at ¶ 10. She was seen by NP Bejarno and she
received a Tdap vaccine administered into her right shoulder. Id. Petitioner recalls: “ I
developed right shoulder pain immediately following my Tdap vaccination. I had constant
moderate pain for approximately 10 days after the vaccination.” Id. at ¶ 11. Petitioner recalls
that she called the medical practice and that someone returned her call and advised “to give it
some time and the pain should diminish.” Id. “Thereafter, my pain became intermittent and I
was hopeful that with time my pain would go away.” Id. However, over the ensuing months,
petitioner had continued “intermittent” right shoulder pain for which she used ice packs, essential
oils, and over-the-counter pain medications which provided temporary relief.” Id. at ¶ 13.
Petitioner recalls that on March 4, 2016, when she presented for a diabetic exam follow
up with NP Bejarno, she reported her increased stress due to various factors. Petitioner recalls
also reporting: “I have been experiencing intermittent right shoulder pain since I received my
Tdap shot in November 2015. [NP Bejarno] advised me to take over the counter pain medication
and give it time.” Id. at ¶ 14.
Petitioner recalls that on March 12, 2016, she presented to the urgent care facility “due to
cough, congestion, sore throat for 4-5 days and fever”, where she was diagnosed with acute
bronchitis. Id. at ¶ 15.
Petitioner recalls that she continued to have shoulder pain which was intermittent, but
increased over time and started to interfere with work and activities of daily living. She had
trouble reaching behind her back and across. At times, her right shoulder pain would wake her
up at night. Id. at ¶ 16. She also recounted seeking additional medical attention as set forth in
the records above. See id. at ¶ 17-41.
2. Richard Gear
Petitioner’s husband is a contractor. Pet. Ex. 20 at ¶ 4. He suffers from chronic pain in
association with several injuries sustained in the course of his employment. Id.
The husband recalls that petitioner “received a Tdap vaccination in the fall of 2015.” Id.
at ¶ 5. She did not have any pain or limited range of motion in the right shoulder beforehand. Id.
at ¶ 6. “Within 24 hours of receiving the Tdap vaccination, my wife Ruth Gear complained to
me that she had right shoulder pain from the Tdap vaccination. She said that her shoulder was
swollen. Ruth applied ice packs to her right shoulder. She also took over-the-counter
medication for her right shoulder pain.” Id. at ¶ 7.
8
The husband recalls that “[s]hortly after the Tdap vaccination that injured [petitioner’s
right shoulder”, he started doing more chores around the house such as changing the cat litter and
carrying grocery bags. Id. at ¶ 8. He also recalls that petitioner developed stiffness and limited
range of motion, after which he need to help reaching items from higher shelves. Id. He went on
to detail the extent of petitioner’s suffering as a result of the Tdap vaccination. Id. at ¶ 9.
3. Lexi Gear
The daughter avers that she was born in 1992 and lives with her parents. Pet. Ex. 21 at ¶
4. She recalls that petitioner did not have any pain or limited range of motion in her right
shoulder prior to receiving a Tdap vaccine in November 2015. Id. at ¶ 7. The daughter then
recalls petitioner stating that “her right shoulder was hurting a lot” later that same day. Id. at ¶
5. The daughter recalls that it became painful for petitioner to move her right arm and that
petitioner applied ice packs to the right shoulder hoping that it would help. Id. at ¶ 6. The
daughter recalls that “[w]ithin a few days of the Tdap vaccination”, petitioner called the clinic
where she received the vaccination and complained about her pain, and the clinic said to give it
time. Id. at ¶ 8. The daughter recalls petitioner stating that she was having difficulty at her job
as a nurse due to her shoulder pain and that she also had difficulty completing household tasks.
Id. at ¶ 9-10. The daughter recalls petitioner taking over the counter medications, using heat
pads, and avoiding use of her right arm before seeking medical treatment. Id. at ¶ 11-12.
4. Marjorie Grote
The sister recalls that on Thanksgiving Day, which was on November 26, 20158, she
spoke to petitioner on the phone. Pet. Ex. 19 at ¶ 6. The sister recalls petitioner stating that her
shoulder had been hurting since she got a flu shot9 about two weeks prior. Id. The sister recalls
also speaking on the phone with petitioner the day after Thanksgiving, the timing of which the
sister remembered that her mother-in-law passed away that same day. Id.
The sister recalls that in December 2015, during the Christmas holidays, she visited
petitioner at her home. Id. at ¶ 8. During this visit, petitioner complained about pain and
difficulty reaching, lifting, and carrying things with her right arm, which was her dominant arm.
Id. After Christmas, during their phone conversations, petitioner continued to complain about
her ongoing shoulder pain and the sister urged her to see a doctor. Id. at ¶ 9.
The sister avers: “My sister Ruth is a very caring and giving person. She puts everyone
else before her.” Id. at ¶ 10. The sister recalls petitioner’s responsibilities caring for her multiple
family members during the relevant time. Id. at ¶ 11. The sister avers that these family
obligations contributed to petitioner’s delay in seeking treatment for her right shoulder. Id. at ¶¶
8
See Calendar for Year 2015 (United States), available at
https://www.timeanddate.com/calendar/?year=2015&country=1.
9
This may represent either an incorrect memory of what vaccine petitioner received or an inadvertent error in the
affidavit. Petitioner in fact received a Tdap vaccination on November 13, 2015. Pet. Ex. 1 at 1.
9
11, 12. Additionally, petitioner “was hopeful that her pain would diminish over time”; she did
not seek treatment until the pain actually persisted and got worse. Id. at ¶ 13.
5. Jane Washington
Ms. Washington states that she has been employed by Unity Point Health System, at
Blank Children’s Hospital, in the NICU as a RN since 1981. Pet. Ex. 18 at ¶ 3. She recalls
meeting petitioner “many years ago at work” in the NICU, where they both remain employed.
Id. at ¶ 4. Ms. Washington saw petitioner approximately three days per week during 2015 –
2016. Ms. Washington recalled that “sometime in the fall of 2015”, petitioner complained about
getting a vaccination in her shoulder and afterwards developing pain, loss of range of motion,
and weakness. Id. at ¶ 6. Petitioner had difficulty raising her arm above her head and asked for
help reaching top shelves. Id. at ¶ 9.
IV. Party Contentions
In her motion for a ruling that onset of her shoulder injury occurred immediately and
therefore within 48 hours of the Tdap vaccination on November 13, 2015, petitioner
acknowledges that there are no medical records of the injury until June 23, 2016. Pet. Mot. at
21. She avers that she prioritized taking care of her elderly father, adult daughter, and husband –
in addition to her work obligations – during this period. Pet. Mot. at 13. Petitioner argues that
on March 4, 2016, she reported the right shoulder injury to NP Bejarno, who “omitted [their]
discussion” either intentionally (because petitioner was alleging that the vaccine was
administered improperly by NP Bejarno) or unintentionally (because the purpose of the visit was
management of petitioner’s diabetes and petitioner’s mental health was an additional topic of
discussion). Pet. Mot. at 12-13; Pet. Reply at 4-7. Petitioner argues that the March 12, 2016
urgent care record did not address her shoulder because the visit was “specifically to address her
urgent needs such as fever and symptoms of bronchitis. Pet. Mot. at 13; see also Pet. Reply at 7.
Petitioner argues that there is support from the medical records beginning on June 23, 2016. Pet.
Mot. at 8-11. Petitioner argues that her own affidavit and four other witnesses’ affidavits are
credible and consistent with the medical records which do address the right shoulder injury. Pet.
Mot. at 11-17, citing Pet. Exs. 1, 18-21.
In response, respondent argues that a special master may not make a finding based upon
the claims of petitioner alone. Resp. Response at 12, citing § 300aa-13(a)(1). “Ultimately, the
petitioner must substantiate the occurrence of a compensable, vaccine-related injury with
independent evidence.” Resp. Response at 12, quoting Lett v. Sec’y of Health & Human Servs.,
39 Fed. Cl. 259, 260 (1997) (denying review of the special master’s determination that the
petitioners did not present independent evidence supporting that their daughter experienced
seizures). Respondent correctly notes that medical records are presumed to be accurate and
complete, then argues that at the March 4, 2016 appointment with NP Bejarno, “petitioner’s
musculoskeletal exam was unremarkable”. Id. at 14, citing Pet. Ex. 3 at 29-34. Therefore,
respondent argues that “the medical records establish that petitioner’s right shoulder pain did not
begin within days of vaccination (and instead likely began closer to seven months after
vaccination)”. Id. Petitioner replies that the March 4, 2016 appointment record does not state
that her musculoskeletal exam was “unremarkable”, instead, it states: “no cyanosis, clubbing, or
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edema”. Pet. Reply at 6-7 (defining each term). Petitioner avers that the musculoskeletal
notation shows only that petitioner “did not have skin discoloration, bulbous enlargement of her
toes/fingers, and/or swelling.” Id. at 7. Thus, the March 4, 2016 record does not provide
conflicting evidence, but rather it is silent about right shoulder pain. Id.
Respondent also argues: “There is no evidence to conclude (especially based on the
alleged severity of the symptoms) that petitioner would wait nearly seven months to seek
treatment and fail to mention those symptoms, particularly when as a health care worker,
petitioner presumably had ready access to health care providers.” Id. at 15. Respondent adds:
“Presumably if petitioner’s shoulder pain was described, it would have come to the attention of
more than one of her coworkers as her work required her to routinely pick up infants.” Id.
Petitioner did not reply to these arguments.
Finally, respondent asserts: “If one accepts that [petitioner] did experience immediate
pain, which was then followed by ten days of moderate pain, petitioner’s own affidavit asserts
that the shoulder pain became ‘intermittent’ which is not sufficient on petitioner’s ipse dixit to
establish that the intermittent pain had the same point of origination as the moderate but
continuous pain that persisted for ten days post-vaccination.” Id. at 12. Petitioner replies that
her shoulder pain began immediately after the vaccination, was moderate for about 10 days, then
improved somewhat but remained “intermittent.” Pet. Reply at 3-4, citing Pet. Ex. 5 at 6.
V. Discussion and Conclusion
Following a review of the entire record and the parties’ briefs, I find that there is
preponderant evidence that petitioner’s right shoulder pain began within 48 hours of the Tdap
vaccination on November 13, 2015. I disagree with respondent that petitioner’s pain instead
began seven months after the vaccination.
Respondent cites Lett for the proposition that: “Ultimately, the petitioner must
substantiate the occurrence of a compensable, vaccine-related injury with independent evidence.”
Resp. Response at 12, quoting Lett, 39 Fed. Cl. 259, 260. A comparison to Lett actually
demonstrates the relative strength of the evidence for petitioner’s allegations here.
First, in Lett, none of the medical records supported the petitioners’ allegations that their
child had experienced seizures. 39 Fed. Cl. 259, 262. Medical records from an alleged
emergency room visit and the hospital’s doctor on duty were never found. Id. In contrast, the
current claim includes medical records, dated beginning June 23, 2016, supporting that
petitioner’s shoulder pain began after the Tdap vaccination. See Pet. Ex. 17 at 1 (“right shoulder
pain… since last year… when she had her tetanus shot in 2015, she feels like the immunization
was given wrong”); Pet. Ex. 6 at 1 (“started having pain in Nov 2015 after getting a vaccine and
pain has not gone away”); Pet. Ex. 5 at 6 (“She apparently had a Tdap vaccination at her family
physician’s office… She had moderate pain for about a 10-day period… It did improve to some
degree but she continued to have intermittent symptoms”); Pet. Ex. 3 at 35-37 (“her shoulder
pain has been a problem for the past 9 months. She reports that when she had her tetanus shot in
Nov 2015, she feels like the immunization was given wrong. Since that time she has had
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intermittent pains in the right shoulder”); Pet. Ex. 9 at 1-3 (“she thinks that she had some pain
that began with a T-dap vaccination at her family’s office”).
Respondent correctly notes that there is a gap in petitioner’s medical records after the
November 13, 2015 appointment where she received the Tdap vaccination. However, I do not
share respondent’s presumption that based on petitioner’s employment as a NICU nurse at a
children’s hospital, she would have “ready access to health care providers” to treat her shoulder
injury. Resp. Response at 15. The medical records actually demonstrate that petitioner relied on
scheduled appointments with her primary care provider NP Bejarno. In one instance, petitioner
had a 4-5 day history of cough, congestion, and sore throat, as well as one day of fever. One
might presume that if petitioner had “ready access to health care providers” through her
employment, she would have taken advantage of those contacts. But instead, she went to an
urgent care facility. Pet. Ex. 4 at 4-6. The medical records also establish that petitioner had
significant obligations not only with work but also in caring for several close family members
with medical issues, whose needs she tended to put in front of her own. See, e.g., Pet. Ex. 14 at
23; Pet. Ex. 3 at 2-6, 16-19, 29-34.
With regard to the post-vaccination medical records not mentioning shoulder pain, I find
reasonable petitioner’s explanation that the January 25, 2016 encounter was only for a bone
density exam and a mammogram, for which she did not see a doctor, only a technician. See Pet.
Ex. 3 at 57-60; Pet. Ex. 1 at ¶ 12. I also find reasonable petitioner’s explanation that the March
12, 2016 record does not mention her right shoulder because this was an urgent care visit focused
on assessment and treatment of acute bronchitis. See Pet. Ex. 4 at 4-6; Pet. Mot. at 3; Pet. Reply
at 7. That leaves the March 4, 2016 appointment with NP Bejarno. Pet. Ex. 3 at 29-34.
Respondent argues that this record is accurate, complete, and reflects that petitioner’s
musculoskeletal exam was “unremarkable.” Resp. Response at 12. However, the record does
not state “unremarkable”. It states only: “Musculoskeletal: no cyanosis, clubbing, or edema”,
which, as petitioner persuasively argues, does not expressly address the presence or absence of
shoulder pain. Pet. Reply at 6-7. This field appears to be pre-filled or duplicated, because the
records from at least the previous two appointments with NP Bejarno have the same exact
notation. See Pet. Ex. 3 at 27 (November 13, 2015), id. at 18 (July 24, 2015). Additionally, the
March 4, 2016, appointment was for a fasting medication check. See id. at 24. While medical
records are presumed to be accurate and complete, there is no indication that this appointment
included an assessment of the shoulder. Here, the medical records all merit consideration, and
some support petitioner’s allegations. They certainly present a closer question than the utter
absence of corroborating records in Lett.
In Lett, the Court of Federal Claims recognized that a petitioner may corroborate her
claim not only via “medical records, or by a credible expert medical opinion” but also via
“testimony of one or more other witnesses”. 39 Fed. Cl. 259, 261. In Lett, the petitioners did not
have any other witnesses with independent recollection of the events in question. In contrast, in
the current claim, petitioner has submitted four other witnesseses’ independent recollections of
her shoulder injury. Pet. Exs. 18-21. Respondent argues that these individuals – petitioner’s
husband, daughter, sister, and long-time coworker – are “interested parties” whose accounts
should not be credited. Resp. Response at 15. However, it is not obvious that these individuals
will benefit from a favorable ruling in petitioner’s claim and there is no evidence that they are
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acting in bad faith. Family members, friends and work associates are also the people most likely
to have heard petitioner’s complaints of pain and to have observed her limitations with activities
of daily living such as difficulty reaching overhead or applying ice packs to the shoulder These
individuals have provided detailed recollections of petitioner suffering the onset of right shoulder
pain beginning within 48 hours of her vaccination. See, e.g., Pet. Ex. 19 at ¶ 6 (the sister’s
recollection that on Thanksgiving Day, November 26, 2015, petitioner complained of shoulder
pain beginning about two weeks prior); Pet. Ex. 18 at ¶ 6 (the coworker’s recollection that
petitioner developed left shoulder pain following a vaccination in fall 2015). The sister also
confirms that petitioner was dealing with significant personal stressors including her mother’s
death in April 2015, resulting in petitioner becoming the primary caretaker for her father who
passed away in summer 2016. See Pet. Ex. 1 at ¶ 8; Pet. Ex. 19 at ¶¶ 10-12. Together with the
commonly given advice to “give it time” and her hope that her shoulder pain would go away, I
find this to be a compelling explanation for petitioner’s delay in seeking treatment for her right
shoulder and also perhaps failing to mention the right shoulder pain in the March 4, 2016
appointment with NP Bejarno.
Respondent also seems to fault petitioner for submitting the affidavit of only one
coworker. Resp. Response at 15. There is no evidence in the record that petitioner was unable
to locate other such coworkers with recollections of her shoulder injury and respondent did not
make that request before briefing this issue. I do not see reason to fault petitioner or her counsel
for submitting the affidavit of only one coworker.
Finally, respondent argues that even if petitioner establishes that she had “moderate but
continuous pain that persisted for ten days post-vaccination”, there is insufficient evidence
connecting that to her later “intermittent pain”, which might have had a different “point of
origination”. Resp. Response at 12. I agree with petitioner that there is no clear distinction
between the immediate shoulder pain alleged by petitioner and her supporting witnesses, and the
shoulder pain recorded in the later contemporaneous medical records. See Pet. Reply at 6.
VI. Conclusion
In accordance with the above and a review of the record as a whole, I hereby find that the
onset of petitioner’s right shoulder pain was within 48 hours after the administration of the
November 13, 2015 Tdap vaccine.
The following is ORDERED:
1) The parties shall file a joint status report proposing further proceedings within 30
days, by Monday, September 21, 2020.
IT IS SO ORDERED.
s/ Thomas L. Gowen
Thomas L. Gowen
Special Master
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