Juno v. Secretary of Health and Human Services ( 2021 )


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  •     In the United States Court of Federal Claims
    OFFICE OF SPECIAL MASTERS
    No. 18-0643V
    UNPUBLISHED
    DEBRA JUNO,                                                 Chief Special Master Corcoran
    Petitioner,                            Filed: September 13, 2021
    v.
    Special Processing Unit (SPU);
    SECRETARY OF HEALTH AND                                     Findings of Fact; Onset; Influenza
    HUMAN SERVICES,                                             (Flu) Vaccine; Shoulder Injury
    Related to Vaccine Administration
    Respondent.                            (SIRVA)
    Bridget Candace McCullough, Muller Brazil, LLP, Dresher, PA, for Petitioner.
    Debra A. Filteau Begley, U.S. Department of Justice, Washington, DC, for Respondent.
    FINDINGS OF FACT1
    On May 7, 2018, Debra Juno filed a petition for compensation under the National
    Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine
    Act”). Petitioner alleges that she suffered a shoulder injury related to vaccine
    administration (“SIRVA”) as a result of an influenza (“flu”) vaccine administered to her
    right shoulder on October 10, 2016. Petition at 1. The case was assigned to the Special
    Processing Unit of the Office of Special Masters.
    For the reasons discussed below, I find the onset of Petitioner’s shoulder injury
    related to vaccine administration (“SIRVA”) occurred within 48 hours of vaccination.
    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    Because this unpublished fact ruling contains a reasoned explanation for the action in this case, I am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).
    I.     Relevant Procedural History
    Ms. Juno filed her petition for compensation along with medical record exhibits on
    May 7, 2018. (ECF No. 1). After reviewing the records, Respondent filed a status report
    stating that he was amenable to engaging in settlement discussions, and requested that
    Petitioner provide a demand. (ECF No. 14). The parties were unable to resolve the case
    after more than a year of settlement discussions, however, so I ordered Respondent to
    file the Rule 4(c) Report to identify the area of disagreement. (ECF Nos. 36, 37).
    Respondent did so on February 2, 2020, maintaining therein that the case was not
    appropriate for compensation under the terms of the Vaccine Act. Respondent’s Report
    at 1 (ECF No. 38). Respondent argued that “petitioner’s records do not establish that her
    shoulder pain began within 48 hours of vaccination, and when she first sought treatment
    three weeks after vaccination, she actually reported bilateral shoulder pain.” Id. at 6.
    Respondent further argued that Petitioner does not allege in the alternative that her
    shoulder pain was caused-in-fact by the vaccination, and thus, cannot prove a causal link
    between the alleged injuries and a covered vaccine. Id. at 7-8.
    Petitioner filed a motion for a fact ruling (“Br.”) to resolve the onset issue. (ECF No.
    43). Respondent filed his response (“Opp.”) on July 13, 2020. (ECF No. 44). Petitioner
    filed a reply (“Reply”) on July 27, 2020. (ECF. No. 45). The matter is now ripe for
    adjudication.
    II.    Issue
    At issue is whether the onset of Petitioner’s right 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) (influenza vaccination) and 100.3(c)(10).
    III.   Authority
    Pursuant to Vaccine Act § 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.
    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).
    2
    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
    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
    3
    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.     Parties’ Positions
    a. Petitioner’s Arguments
    Petitioner asserts that her right shoulder pain started within 48 hours of
    vaccination. Br. at 6-7. She notes that there are no complaints of shoulder pain prior to
    vaccination, and that in all her post-injury medical records she continuously related her
    right shoulder pain back to the flu vaccination. Id. at 7. In particular, just three weeks after
    vaccination, Ms. Juno specifically complained to her primary care physician about the
    pain in her shoulder “since” receiving the vaccinations on October 10, 2016. Id. And in all
    subsequent records that mention onset, Petitioner continued to relate her right shoulder
    pain back to her flu vaccination. Id. Petitioner also argues that the medical records are
    supported by her sworn testimony and the testimony of her fact witnesses. Id. at 8.
    b. Respondent’s Arguments
    Respondent, on the other hand, argues that the 48-hour onset is only described in
    Petitioner’s own statement and not corroborated by any objective evidence. Opp. at 4.
    Respondent states that Petitioner “cannot overcome inconsistencies or discrepancies in
    the medical records by simply filing Affidavits that state her preferred onset date.” Id. at
    8. Respondent notes that in Petitioner’s initial visit to her PCP, she complained of bilateral
    arm pain, and because the record does not specifically state “right” shoulder when
    referring to the arm pain, such an inference cannot be made. Respondent also argues
    that the term “worsening” can also relate to an onset of shoulder pain prior to vaccination.
    Id. Finally, Respondent states that the Dearborn disability documents filed by Petitioner
    which report an onset of shoulder symptoms within 48-hours of vaccination do not
    substantiate her claim. Therefore, Petitioner’s SIRVA claim should be denied.
    V.      Finding 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, the parties’ briefing and any
    additional evidence filed. Specifically, I base the findings on the following evidence:
    4
       Ms. Juno’s past medical history is significant for hypothyroidism, restless leg
    syndrome, gastric reflux, and a hiatal hernia. Petitioner’s Exhibit (“Ex.”) 2 at 2.
    She also reported a remote history of elbow surgery. Ex. 4 at 36.
       Approximately 10 days prior to receiving the vaccination at issue, on September
    27, 2016, Ms. Juno was seen by her primary care provider (“PCP”), Dr. Elham
    Siddiqui, for an annual exam. She reported “no current complaints,” and her
    exam was normal. There is no history of shoulder complaints noted. Ex. 2 at 22-
    24.
       Ms. Juno was 60 years old when she was administered a flu vaccine in her right
    shoulder on October 10, 2016, by a nurse at her PCP’s office. Ex. 1 at 1; Ex. 7 at
    8. Ms. Juno also received the Pneumovax 23 vaccine in her left deltoid during
    this visit. Id.
       In her affidavit, Ms. Juno recalled that “[i]mmediately following the influenza
    vaccination, I began to develop pain in my right shoulder.” Ex. 10 at 1, ¶2. She
    stated that the nurse administering the vaccination was standing, while Ms. Juno
    was seated. Ex. 11 at 1, ¶3.
       Ms. Juno stated in her affidavit that she was advised by her PCP’s office to wait a
    week to see if her shoulder pain subsided. Id. at ¶ 6. When the pain did not
    subside, she contacted her PCP again and made an appointment for November
    2, 2016. Id. at ¶7.
       On November 2, 2016, 23 days after vaccination, Ms. Juno presented to Dr.
    Siddiqui complaining of “worsening arm pain since getting flu and pneumonia
    vaccines.” Ex. 2 at 36. Dr. Siddiqui diagnosed her with bilateral arm pain and
    myalgia. She was prescribed a steroid taper. Id. at 38.
       By December 14, 2016, Ms. Juno was still experiencing pain in her right
    shoulder. She returned to her PCP stating that she “still [had] difficulty raising her
    arm, can’t take shirt off”, “aching, can’t reach behind,” “very sore to touch.” Ms.
    Juno stated that she had tried steroid and anti-inflammatory medications to no
    avail. Ex. 2 at 32. On exam, she exhibited decreased range of motion of the right
    shoulder, tenderness, pain and decreased strength. Id. at 34. Dr. Siddiqui
    ordered an MRI. Id.
       On December 21, 2016, Ms. Juno underwent an MRI of her right shoulder which
    demonstrated a “full thickness supraspinatus tear, partial bursal sided
    infraspinatus tear, and moderate osteoarthritis of the acromioclavicular joint.” Ex.
    2 at 64.
    5
       On January 11, 2017, Ms. Juno was examined by orthopedic surgeon, Dr. John
    McPhilemy, who noted that Ms. Juno “began to experience right shoulder
    symptoms following a flu shot she received on or about 10/10/2016. Symptoms
    have persisted over the past three months…” Ex. 5 at 6-7. He recommended
    arthroscopic surgery to repair the tears, followed by a course of physical therapy.
    Id. at 7.
       On January 20, 2017, Ms. Juno underwent a right shoulder arthroscopic shoulder
    repair. Ex. 3 at 9. The postoperative diagnoses included: (1) rotator cuff tear,
    right shoulder, (2) degenerative glenoid labrum tear, and (3) early osteoarthritis,
    right glenohumeral joint. Id.
       Five days later, on January 25, 2017, Ms. Juno was examined by Dr. McPhilemy
    who noted that Ms. Juno’s incisions were healing and there were no signs of
    infection or deep vein thrombosis. Ex. 5 at 5. She was to be reexamined in one
    week.
       Ms. Juno had several post-operative appointments with Dr. McPhilemy on
    February 1, 8, and 27, 2017. See generally Ex. 3, 5.
       On March 27, 2017, nine weeks after surgery, Dr. McPhilemy noted that Ms.
    Juno’s pain was “slowly improving” although she was not yet pain free. Ex. 3 at 3.
    He recommended that Ms. Juno work with a physical therapist to improve her
    range of motion and to prevent adhesive capsulitis. Id.
       By April 17, 2017, Dr. McPhilemy noted that Ms. Juno’s range of motion “is
    improved to about 90% of normal, pain is improved and strength is about 85% of
    normal.” Ex. 3 at 2. Dr. McPhilemy recommended that Ms. Juno continue with
    physical therapy for another two weeks. Id.
       At her May 3, 2017 appointment with Dr. McPhilemy, Ms. Juno’s right shoulder
    had improved but she was not pain free. Ex. 3 at 1. Dr. McPhilemy confirmed that
    Ms. Juno still had some restriction in her right shoulder and “uncomfortable
    internal rotation”, but all other motion was “pretty close to normal.” Strength was
    90% of normal. Id.
       Ms. Juno attended post-surgical physical therapy from March 27, 2017 to May
    31, 2017. See generally Exs. 3, 4. She was discharged from physical therapy on
    May 31, 2017, to a home exercise program. Ex. 3 at 5.
       Ms. Juno filed a short-term disability claim with Dearborn National Disability on
    January 25, 2017. Ex. 12 at 10-11. Petitioner listed her injury as “torn rotator cuff”
    6
    with symptoms first manifesting on October 11, 2016, one day after vaccination.
    Id.
    The record as summarized above preponderantly supports the conclusion that
    Petitioner experienced right shoulder pain immediately after administration of the flu
    vaccine on October 10, 2016. Despite Respondent’s reluctance to admit that Petitioner
    reported her right shoulder pain just three weeks after vaccination, the records make clear
    that Petitioner’s right shoulder pain began immediately after vaccination and within the 48
    hour onset period to prove a SIRVA claim.
    Thus, just 23 days after vaccination, Ms. Juno had an appointment with her PCP
    to specifically complain of her shoulder pain. In her affidavit, she states that she called
    her PCP’s office more than once to complain of shoulder pain, although the phone records
    have not been filed into the record. But clearly Ms. Juno made at least one phone call to
    set the November 2, 2017 appointment – and it was within a month of the vaccine’s
    administration.
    In addition, the record from that first appointment with Dr. Siddiqui states that Ms.
    Juno complained of “worsening arm pain since getting flu and pneumonia vaccines.” Ex.
    2 at 36 (emphasis added). This descriptor “worsening” indicates that Ms. Juno’s bilateral
    shoulder pain started prior to the November 2, 2017 visit, and provides further evidence
    that her bilateral arm pain, which includes the right shoulder, was “worsening” “since”
    receiving the vaccinations – supporting the contention that the pain itself began at or close
    to the time of vaccination. Respondent’s view that the term “bilateral” discounts the
    possibility of a Table onset is not persuasive, since Dr. Siddiqui clearly stated that Ms.
    Juno’s arm pain stemmed from both the flu and pneumonia vaccines (and both are
    grounds for a Table SIRVA claim). Equally unpersuasive is Respondent’s argument that
    bilateral pain means Petitioner could not have experienced pain in her right shoulder after
    receiving the flu vaccine. The medical record allows the conclusion that her left arm pain
    from the Pneumovax vaccine resolved (consistent with the vast majority of vaccinations),
    while the right arm pain lingered, and therefore it is the actionable vaccination.
    The other factor that weighs in my finding of the 48-hour onset of right shoulder
    pain is the absence of any statement or record that places the onset of Ms. Juno’s right
    shoulder pain outside the 48-hour window. While Respondent correctly notes in a footnote
    that Dr. McPhilemy’s record memorialized a three-month history of arm pain - which if
    correct would place the onset of right shoulder pain prior to vaccination (see Opp. at 2,
    fn. 2) - it is clear that Dr. McPhilemy was generalizing the onset period, rather than
    precisely calculating the period for legal purposes (as is done in Vaccine Program
    7
    cases).3 Dr. McPhilemy otherwise clearly sets the onset of Petitioner’s right shoulder pain
    as starting on 10/10/2016, and taken as a whole, this is the most reasonable interpretation
    of his entire statement.
    Respondent further argues that Petitioner cannot overcome inconsistencies or
    discrepancies in the medical records simply by filing affidavits that gainsay or modify what
    the records set forth. But the Federal Circuit has expressly recognized that witness
    testimony on issues pertaining to fact matters like symptoms onset can be proven through
    this kind of evidence (even if they must be weighed against the records, which also have
    evidentiary significance). Kirby, 997 F.3d at 1383. Respondent has not otherwise
    identified any other inconsistencies or discrepancies in the medical records. All other
    references to onset clearly relate Petitioner’s right shoulder pain as occurring immediately
    after vaccination.
    Finally, Respondent questions the weight to be given affidavits filed by Petitioner
    in support of her claim of onset, noting in particular that Ms. Juno’s second and third
    affidavits were written over three years after her October 10, 2016 flu vaccination, “and
    petitioner did not explain why she did not provide any of that information to her treating
    doctor’s when she first sought treatment.” Opp. at 3. While I accept that the date of some
    contentions or witness statements can be relevant to the weight they should be given, I
    also note that such matters are a “two-way street.” Thus, as Petitioner aptly notes in her
    Reply brief, Respondent filed his Rule 4(c) report challenging the issue of onset on
    February 6, 2020 - a total of 640 days (21 months) after the Petition was filed. It was not
    obvious that onset would be challenged in this case, especially since Petitioner reported
    her shoulder injury less than 30 days after vaccination, and given that the parties did seek
    to settle the matter for some time.
    Weighing the evidence on the preponderance standard, I overall find that Petitioner
    has met her burden. One of the most significant pieces of evidence is the fact that Ms.
    Juno was seen by her primary care physician for her right shoulder pain just 23 days after
    she was administered the flu vaccine. There are also many references in the medical
    records (as listed above) that squarely place the onset of Ms. Juno’s shoulder pain in the
    48-hour window. Despite Respondent’s seeming view that only evidence of onset in
    records prepared within the 48-hour period set by the Table is credible, the Act says
    otherwise. § 13(b)(2). Taken as a whole, I find the sworn testimony of Ms. Juno to be
    credible and in agreement with most of the contemporaneously created treatment
    records.
    3
    The entire statement by Dr. McPhilemy states that Ms. Juno “began to experience right shoulder pain
    symptoms following a flu shot she received on or about 10/10/2016. Symptoms have persisted over the
    past three months.” Ex. 5 at 6-7.
    8
    Accordingly, I find the onset of Petitioner’s pain within 48 hours of vaccination.
    VI.      Scheduling Order
    Given my finding of fact regarding the onset of Ms. Juno’s right shoulder pain,
    Respondent should evaluate and provide his current position regarding the merits of
    Petitioner’s case.
    Accordingly, Respondent shall file, by no later than Friday, October 15,
    2021, 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
    9