Court Opinion

ID: 7798092
Source: CourtListenerOpinion
Date Created: 2022-08-05 13:01:26.01302+00
Date Added: 2024-06-11T16:28:43.956840
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                           No. 19-0002V
                                          UNPUBLISHED

    CECILIA ORTIZ,                                              Chief Special Master Corcoran

                         Petitioner,                            Filed: June 30, 2022
    v.
                                                                Special Processing Unit (SPU);
    SECRETARY OF HEALTH AND                                     Findings of Fact; Onset; Tdap
    HUMAN SERVICES,                                             Vaccine; Shoulder Injury Related to
                                                                Vaccine Administration (SIRVA)
                         Respondent.

Amy A. Senerth, Muller Brazil, LLP, Dresher, PA, for Petitioner.

Sarah Christina Duncan, U.S. Department of Justice, Washington, DC, for Respondent.

                                           FINDINGS OF FACT1

      On January 2, 2019, Cecilia Ortiz filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the
“Vaccine Act”). Petitioner alleged that she suffered a shoulder injury related to vaccine
administration (“SIRVA”) as a result of a tetanus, diphtheria, and pertussis vaccine
(“Tdap”) administered to her left shoulder on January 20, 2016. Petition at 1. The case
was assigned to the Special Processing Unit of the Office of Special Masters.

1
   Because this unpublished fact ruling contains a reasoned explanation for the action in this case, I am
required to post it on the United States Court of Federal Claims' website in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the fact ruling will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2
 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
       After review of the record and other filings, and for the reasons discussed below, I
find that Petitioner’s left shoulder pain likely began within the 48-hour timeframe for the
Table claim.

    I.      Relevant Procedural History

       Ms. Ortiz filed her petition for compensation along with medical record exhibits
from January to March 2019. (ECF No. 1). Ten months later, Respondent filed a status
report stating that he did not believe engaging in settlement discussions was appropriate
and proposed filing his Rule 4(c) Report. (ECF No. 28).

        On January 6, 2020, Respondent filed his Rule 4 (c) Report contesting entitlement
in this case. (ECF No. 29). Specifically, Respondent argued that Petitioner’s Table SIRVA
claim failed because she had not established that the onset of her shoulder pain began
within 48 hours after receiving her Tdap vaccination on January 20, 2016. Respondent’s
Report at 7-8. In support, Respondent noted that five days after vaccination, Petitioner
presented to the office of her primary care physician, but did not report any shoulder pain
or vaccine related complaints. Id.; citing Ex. 2 at 34-35.3 Thereafter, Petitioner did not
report shoulder pain to any medical provider for nearly five months, despite her claim that
she was wearing a sling and taking Motrin daily. Id. at 8.

        The parties subsequently filed briefing requesting a ruling on onset. My ruling is
set forth below.

    II.     Issue

       The issue presented for resolution is whether the onset of Petitioner’s left shoulder
pain occurred within 48 hours after vaccination, as required by the Vaccine Injury Table.
42 C.F.R. §§ 100.3(a) XIV.B. (2017) (Tdap vaccination) and 100.3(c)(10).

    III.    Authority

       Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the petition by Vaccine Act
§ 11(c)(1). A special master must consider, but is not bound by, any diagnosis,
conclusion, judgment, test result, report, or summary concerning the nature, causation,
and aggravation of petitioner’s injury or illness that is contained in a medical record.
§ 13(b)(1). “Medical records, in general, warrant consideration as trustworthy evidence.

3
  Respondent also argued that Petitioner has not established that she suffered a non-Table injury because
there is insufficient evidence that the vaccine administration caused her to suffer a left shoulder injury and
because she has not filed an expert report supporting her claim. Id. at 8.

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The records contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions. With proper treatment hanging in the
balance, accuracy has an extra premium. These records are also generally
contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Human Servs.,
993 F.2d 1525, 1528 (Fed. Cir. 1993).

       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 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 United States Court of Federal Claims has recognized that “medical records
may be incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed.
Cl. 381, 391 (1998). 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). However, the Federal Circuit recently
“reject[ed] as incorrect the presumption that medical records are accurate and complete
as to all the patient’s physical conditions.” Kirby v. Sec’y of Health & Hum. Servs., 997
F.3d 1378, 1383 (Fed. Cir. 2021). 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).

        A special master may find that the first symptom or manifestation of onset of an
injury occurred “within the time period described in the Vaccine Injury Table even though
the occurrence of such symptom or manifestation was not recorded or was incorrectly
recorded as having occurred outside such period.” § 13(b)(2). “Such a finding may be
made only upon demonstration by a preponderance of the evidence that the onset [of the

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injury] . . . did in fact occur within the time period described in the Vaccine Injury Table.”
Id.

       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).

   IV.      Findings of Fact

        I make the following findings after a complete review of the record to include all
medical records, affidavits, Respondent’s Rule 4(c) Report, and any additional evidence
filed. Specifically, I observe as follows:

        Ms. Ortiz received a Tdap vaccine in her left deltoid on January 20, 2016. Ex. 1
         at 3-4. She was 50 years-old at the time.

        Ms. Ortiz’s medical history includes a pulmonary embolism in 1991,
         hypertension, hyperlipidemia, obesity, and allergic rhinitis. Ex. 2 at 39-45; Ex. 7
         at 34-45. There is no indication in the records of any previous left shoulder
         injuries.

        On January 25, 2016, five days after vaccination, Petitioner presented to her
         primary care physician (“PCP”) complaining of feeling sluggish and eating more
         than usual, possibly in relation to her blood pressure medications. Ex. 2 at 34-38.
         There is no mention of any shoulder complaints during this visit.

        On June 14, 2016, nearly five months after vaccination, Ms. Ortiz presented to
         her Nurse Practitioner Bettina Raju (“NP Raju”) at her PCP’s office complaining
         of “left shoulder pain off an[d] on x6 months. States January had Tdap
         vaccination in left deltoid and noticed pain occurring after injection. Most pain
         occurs when twisting arm to put on bra with occasional numbness and tingling to
         extremity when in same position for extended periods of time. Denies trauma or
         injury. Has tried various OTC analgesics with minimal improvement and tried hot
         stone massage which helped for some time. Participating in yoga exercises.” Ex.
         2 at 30. On examination, Petitioner’s left shoulder was tender to palpation and
         she had a reduced range of motion, although the nerve impingement test was
         negative. Id. at 31. NP Raju noted that Petitioner’s left shoulder pain radiated into

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    her neck and arm. Id. Ms. Ortiz was assessed with left shoulder bursitis and
    prescribed home physical therapy. She was also instructed to ice the area and
    perform range of motion and stretching exercises. Id.

   On September 1, 2016, Petitioner returned to NP Raju complaining that her
    shoulder pain had not improved with massage therapy, acupuncture and
    massages. Ex. 2 at 26. Instead, her pain was worsening and radiating to the
    lower arm. Id. This time after examination, NP Raju, with Dr. Nicastro, noted that
    Ms. Ortiz was experiencing “moderate-severe spasms, moderate-severe
    tenderness and moderate-severe decreased range of motion.” Id. at 27. An MRI
    of the left upper arm was ordered. Id. at 28.

   Ms. Ortiz underwent an MRI of her left shoulder on September 2, 2016. Ex. 2 at
    51. The clinical history states “No trauma. Very sharp stabbing sensation from
    left shoulder joint down to hand. Pain started Jan. 2016.” The impression was
    “Distal supraspinatus tendinopathy” and “hypertrophic changes of the
    acromioclavicular joint with evidence of impingement.” Id.

   On September 8, 2016, Ms. Ortiz returned to NP Raju to review the results of her
    MRI. Ex. 2 at 21-23. Ms. Ortiz reported that the pain medication was helping her
    a little, but she was concerned because she was going out of the country on a
    backpacking trip and worried that her shoulder pain might worsen. Id. The
    Apley’s Scratch Test (to measure reduced range of motion) was “[p]ositive for
    tendonitis of the rotator cuff.” Id. at 22. NP Raju noted “moderate-severe spasms,
    moderate-severe tenderness and moderate decreased range of motion” and
    assessed “bicipital tendinitis, left shoulder.” Id. Ms. Ortiz was referred to pain
    management. Id. She was prescribed Tramadol for pain. Ex. 2 at 23.

   On September 14, 2016, Ms. Ortiz underwent a left shoulder injection under
    ultrasound guidance, left cervical paraspinals, trapezius, and rhomboid trigger
    point injections, and a limited ultrasound evaluation of the left shoulder bursa. Ex.
    8 at 2. During the evaluation, mild edema was noted in the subdeltoid bursa. Id.
    at 3.

   On October 10, 2016, Petitioner presented to Nurse Practitioner Kenneth Fuller
    with complaints of “persistent pain on left arm and shoulder.” Ex. 2 at 16. The
    Apley’s Scratch Test was again “[p]ositive for tendonitis of the rotator cuff.” Id. He
    placed a therapy treatment order for “ice, electrical muscle stimulation,
    ultrasound, manipulation, physical medicine and myofascial release.” Id. at 17-
    18.

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   On October 12, 2016, Ms. Ortiz underwent a second left steroid injection with
    ultrasound guidance, left cervical paraspinals, trapezius, and rhomboid trigger
    point injections, and a limited ultrasound evaluation of the left shoulder bursa. Ex.
    8 at 6. The same finding of edema as previously noted was stated in the report.
    Id. at 7.

   On October 24, 2016, Ms. Ortiz presented to Dr. Lacrecia Foster reporting that
    she had been seen by pain management and received three steroid injections.
    Ex. 2 at 10. Petitioner reported that she experienced some improvement but that
    she recently went on a backpacking trip and re-flared her shoulder. Id. at 10. She
    declined repeat injections and had put her arm in a sling to alleviate the pain. Id.
    Ms. Ortiz requested a physical therapy referral as the pain had been waking her
    up at night. Id. Dr. Foster also prescribed a muscle relaxant and Tramadol. Id. at
    13.

   On November 18, 2016, Petitioner underwent an arthrogram of her left shoulder
    which showed “moderate tendinosis … involving the supraspinatus and
    infraspinatus tendon with a shallow low-grade partial thickness articular sided
    tear involving the anterior fibers of the infraspinatus tendon… 2. Partial thickness
    interstitial tear is noted involving the mid fibers of the subscapularis tendon… 3.
    Moderate degenerative changes are noted involving the posterosuperior labrum
    without a definite labral tear … 4. Moderate to severe arthrosis … involving the
    acromio clavicular joint with synovial and capsular hypertrophy. Near total
    effacement of the fat overlying myotendinous junction of the supraspinatus mild
    increasing anatomic risk for impingement.” Ex. 11 at 2-3. She received an intra-
    articular injection of lidocaine in her left shoulder. Ex. 11 at 1.

   On December 22, 2016, Ms. Ortiz underwent surgery – a left shoulder
    arthroscopy, manipulation under anesthesia and lysis of adhesions. Ex. 4 at 3.
    The postoperative diagnosis was left shoulder adhesive capsulitis and left
    shoulder partial thickness supraspinatus tendon tear. Id. at 4. The operative
    report notes that when the subacromial space was visualized during surgery,
    “there was extensive synovitis and bursitis present within the subacromial
    space.” Id. at 5. A complete bursectomy was performed. Id.

   On April 12, 2017, Ms. Ortiz returned to Dr. Foster, for a follow up and treatment
    of “left shoulder pain, cervical pain radiating to left shoulder, arm, and thoracic
    pain.” Ex. 2 at 6. On examination, Dr. Foster noted that Petitioner was positive for
    cervical spine joint and nerve root injury on the left as well as for a supraspinatus
    injury on the left. Id. at 8. Dr. Foster ordered electrical muscle stimulation,
    ultrasound, physical medicine and myofascial release, three times per week for
    two weeks. Petitioner was instructed to return in two weeks. Id.

                                          6
       The last mention of the left shoulder is during an examination on May 4, 2017,
        where it is noted that “bursitis of the left shoulder – stable.” Ex. 7 at 8.

       In an undated letter, Claudia Bonacchi from Cla’-Bo Specialty Day Spa, stated
        that she provided massage services to Ms. Ortiz about 7 times between June
        2017 and September 2018. Ex. 5. Ms. Bonacchi stated that during Petitioner’s
        last session in September 2018, Ms. Ortiz “complained of acute pain under the
        shoulder blade and at the base of the neck.” Id.

       No records have been filed for any treatment after December 27, 2018. Ex. 7 at
        3.

       Ms. Ortiz filed an affidavit to explain the circumstances she recalled surrounding
        her receipt of the Tdap vaccine and to explain her delay in seeking medical
        treatment for her shoulder. Ex. 12 at 1. She stated that on January 20, 2016, “I
        was sitting down, and the vaccine administrator was standing. I thought it was a
        little high up my arm towards my shoulder compared to flu shots I received in the
        past. Immediately following receipt of the Tdap vaccine, I felt pain in my left
        shoulder… but I figured it was normal after a shot so I did not tell anyone.” Ms.
        Ortiz stated that she delayed seeking treatment because she “did not think I
        needed a doctor until the pain was interfering with my sleep and at work the pain
        was there all day.” She stated that she did not mention the shoulder pain at her
        January 25, 2016 visit because “I assumed I was just sore, and didn’t think much
        of it at the time.” Ms. Ortiz stated that she did not return to be seen for shoulder
        pain “because I typically am one to avoid doctors. Instead, I took over the counter
        pain medication, used essential oils, and used a sling and other supports
        because my elbow, wrist and hand hurt from the radiating pain.” Id. at 2, ¶7. It
        was only during an incident where her cousin bumped her arm and the pain was
        so severe that “it took my breath away for a few minutes,” that Ms. Ortiz decided
        that she needed to seek medical care.

   V.      Ruling Regarding Onset

       After a careful review of the record, I find that the evidence preponderates (albeit
barely) in Petitioner’s favor on the disputed onset issue.

        There is no dispute that Ms. Ortiz did not suffer from any left shoulder symptoms
prior to receiving the Tdap vaccine in January 2016. And the record corroborates the fact
of subsequent injury – even though, admittedly, there are no close-in-time treatment
records. It is true that the one close-in-time record (from when Petitioner saw her
physician within a week of receiving the vaccine) does not memorialize a report of pain.
But this is not inconsistent with what other Program petitioners experience, based on the

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assumption that their pain is likely transitory. Indeed, many SIRVA cases feature medical
record notations from physicians recommending that a patient wait a period of time after
vaccination to allow time for the shoulder pain to fade before seeking treatment.
Subsequent records in this case, however, all corroborate the injury and onset, and the
Vaccine Act expressly does not obligate claimants to prove onset issues with evidence
from within the alleged timeframe in any event. Section 13(b)(2).

       The sworn testimony of Petitioner on the onset question is also credible and in
agreement with the contemporaneously created treatment records. I do not agree with
Respondent’s argument that Ms. Ortiz’s two affidavits are inconsistent and that the
“contemporaneous medical records conflicts with petitioner’s recollection.” Respondent’s
Brief at 8. The fact that Ms. Ortiz first averred that she felt pain immediately after
vaccination does not necessarily conflict with the statement in her second affidavit where
she states that the vaccine area was “sore” and “little by little, the soreness became pain.”
Pain threshold is a subjective perception. Soreness may be perceived as pain by some
individuals, but not by others. In any event, Respondent’s argument on this point is weak
and unpersuasive.
       Another factor that weighs in favor of a finding of 48-hour onset of left shoulder
pain is the absence of any statement or record that places the onset of Ms. Ortiz’s left
shoulder pain outside the 48-hour window. By contrast, there are at least two records
where Ms. Ortiz reports that her pain began on the day of vaccination. See e.g., Ex. 2 at
30-33 (regarding pain in her arm “L shoulder pain off/on x 6 months. States in January
had Tdap vaccination in L deltoid and noticed pain occurring after injection.”); Ex. 2 at 51
(“sharp stabbing sensation from L shoulder joint down to hand. Pain started Jan 2016”).

        Unquestionably, the five-month records gap from vaccination to the first efforts to
treat Ms. Ortiz’s alleged shoulder pain undermines Petitioner’s case. As Respondent
argues, it is reasonable to expect that the average Program claimant might seek medical
treatment sooner if in fact the person was experiencing sudden post-vaccination pain.
However, as noted above, claimants may often misperceive the extent of their shoulder
injury, or downplay its significance, leading them to delay treatment. See, e.g., Williams
v. Sec’y of Health & Human Servs., No. 17-830V, 2019 WL 1040410, at *9 (Fed. Cl. Spec.
Mstr. Jan. 31, 2019) (noting a delay in seeking treatment for five-and-a-half months
because petitioner underestimated the severity of her shoulder injury); Tenneson v. Sec’y
of Health & Human Servs., No. 16-1664V, 2018 WL 3083140, at *5 (Fed. Cl. Spec. Mstr.
March 30, 2018), review denied, 142 Fed. Cl. 329 (2019) (finding a 48-hour onset of
shoulder pain despite a nearly six-month delay in seeking treatment); Marino v. Sec’y of
Health & Human Servs., No. 16-622V, 2018 WL 2224736, at *2 (Fed. Cl. Spec. Mstr. Mar.
26, 2018) (noting a delay in seeking treatment for several months due to petitioner’s work
schedule and difficulty making appointments); Knauss v. Sec’y of Health & Human Servs.,

                                             8
No. 16-1372V, 2018 WL 3432906 (Fed. Cl. Spec. Mstr. May 23, 2018) (noting a three-
month delay in seeking treatment).
        Here, as in other cases, Respondent argues that a special master cannot rely on
the statements of the petitioner alone regarding a key element like onset. See e.g., Juno
v. Sec’y of Health & Human Servs., No. 18-643, 2021 WL 4782691, at * 5 (Fed. Cl. Spec.
Mstr. Sept. 13, 2021). But the Federal Circuit has expressly recognized that witness
testimony on issues pertaining to fact matters can be proven by reliance on testimonial
evidence (even if the evidence must be weighed against the records themselves, which
continue to have evidentiary significance). Kirby, 997 F.3d at 1383. Respondent has not
identified any inconsistencies or discrepancies in the medical records. And in this case,
the relevant witness statements are not the only evidence in favor of an onset finding
consistent with a Table SIRVA claim.

       At bottom, the evidence preponderates, although weakly, in favor of a
determination that onset began in 48 hours of vaccination. Of course, the fact of
Petitioner’s delay will bear on any damages to be awarded in this case, since it either
underscores a SIRVA mild enough to be tolerated for a long time, or establishes
Petitioner’s own contributions to severity.4 But these considerations are separate from
whether onset did happen as Petitioner alleges.

    VI.     Scheduling Order

       Given my findings of fact regarding onset of Ms. Ortiz’s left shoulder pain,
Respondent should evaluate and provide his current position regarding the merits of
Petitioner’s case.

          Accordingly, the following is ORDERED:

          (1) By Monday, August 5, 2022, Petitioner shall file all updated medical
              records.

4
  This appears to be a classic example of an individual holding off on medical treatment for what started as
mild shoulder pain, but progressed and worsened to a severe condition – thereby exacerbating the
condition. Guarding or non-use of the shoulder can lead to adhesive capsulitis or frozen shoulder, and
Petitioner’s non-use may have also led to neck and shoulder pain because she began shifting the use of
her left arm to other parts of the body. The backpacking trip she took in October 2016 also likely exacerbated
her pain and symptoms. Due to the lack of care early on, what may have otherwise been a mild shoulder
injury progressed to a serious injury requiring surgical intervention.

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     (2) Respondent shall file, by no later than Monday, August 29, 2022, an
         amended Rule 4(c) Report reflecting Respondent’s position in light of the
         above fact-finding.

IT IS SO ORDERED.

                              s/Brian H. Corcoran
                              Brian H. Corcoran
                              Chief Special Master

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