Morris v. Secretary of Health and Human Services ( 2022 )


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  •     In the United States Court of Federal Claims
    OFFICE OF SPECIAL MASTERS
    No. 19-1570V
    UNPUBLISHED
    VANESSA MORRIS,                                            Chief Special Master Corcoran
    Petitioner,
    v.                                                         Filed: December 15, 2021
    SECRETARY OF HEALTH AND                                    Special Processing Unit (SPU);
    HUMAN SERVICES,                                            Findings of Fact; Onset; Influenza
    (Flu); Shoulder Injury Related to
    Respondent.                            Vaccine Administration (SIRVA);
    Table Claim Dismissal.
    Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for Petitioner.
    Benjamin P. Warder, U.S. Department of Justice, Washington, DC, for Respondent.
    FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CLAIM1
    On October 9, 2019, Vanessa Morris 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 as a result of an influenza (“flu”) vaccine received
    on October 4, 2017, she suffered a shoulder injury related to vaccination (“SIRVA”) as
    defined on the Vaccine Injury Table (the “Table”). Petition (ECF No. 1) at Preamble. The
    case was assigned to the Special Processing Unit of the Office of Special Masters.
    1
    Because this unpublished opinion contains a reasoned explanation for the action in this case, I am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 opinion 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).
    For the reasons discussed below, I find that Petitioner’s Table SIRVA claim must
    be dismissed, because the evidentiary record does not support the conclusion that the
    requisite onset of her pain occurred within 48 hours following administration of the flu
    vaccine.
    I.   Relevant Procedural History
    The Petition and supporting documentation were deemed to be sufficiently
    complete, and the matter was assigned to the SPU in October 2019. On January 12,
    2021, Respondent completed his formal medical review of the case and invited litigative
    risk settlement discussions. ECF No. 20. Petitioner thereafter transmitted a settlement
    demand and supporting documentation on April 12, 2021. ECF No. 22.3 Respondent
    provided an offer on May 6, 2021, but the parties reached an impasse in their
    negotiations. ECF No. 23.
    On August 24, 2021, Respondent filed his Rule 4(c) Report contending that
    Petitioner had not established onset within 48 hours of vaccination, as required for a Table
    SIRVA. Respondent argued that within the medical records, Petitioner provided an
    incorrect date of vaccination on multiple occasions,4 and that she also provided
    inconsistent information regarding the onset of her left shoulder pain. Rule 4(c) Report
    (ECF No. 26) at 14.
    I then directed the parties to file briefs and any other evidence that would assist
    my resolution of the disputed issues. ECF No. 27. Petitioner filed a motion for a ruling on
    the record on October 6, 2021, ECF No. 28, to which Respondent filed a response on
    October 15, 2021, ECF No. 29. Petitioner did not file a reply. This matter is now ripe for
    adjudication.
    II.   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 Section 11(c)(1).
    A special master must consider, but is not bound by, any diagnosis, conclusion, judgment,
    3
    The case does not involve a workers’ compensation claim or a Medicaid lien. ECF No. 10. Petitioner
    initially reported that she was seeking an award for pain and suffering, out of pocket expenses, and lost
    wages She suggested that her lost wages were “complex” and required an expert economist (which request
    I deferred during the parties’ litigative risk settlement discussions). ECF Nos. 19-21.
    4
    However, Respondent recognized that there was preponderant evidence that Petitioner did receive the
    subject flu vaccine on October 4, 2017; that the vaccine was administered in her left deltoid, as alleged;
    and that the vaccine was intended for intramuscular administration. Rule 4(c) Report at 2; n. 2-3.
    2
    test result, report, or summary concerning the nature, causation, and aggravation of
    petitioner’s injury or illness that is contained in a medical record. Section 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).
    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. And 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 & Human Servs., 
    997 F.3d 1378
    ,
    1383 (Fed. Cir. 2021).
    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). 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).
    3
    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.” Section 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
    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.   Relevant Factual Evidence
    I have fully reviewed the evidence pertaining to the onset question, including all
    medical records, Respondent’s Rule 4(c) Report, and the parties’ briefs.5 find most
    relevant the following:
    •   Upon receiving the subject vaccination, Ms. Morris was 58 years old. She was
    generally healthy, with no history of problems with her left shoulder. See, e.g.,
    Ex. 2 at 22-26, 161-99; Ex. 7 at 3-9; Ex. 9 at 7-62; Ex. 10 at 7-78.
    •   Petitioner was employed by Blue Cross Blue Shield in Arkansas. See, e.g., Ex.
    4 at 6, 33; Ex. 5 at 52 (Petitioner’s self-identification as a “specialist”).
    •   On October 4, 2017, a registered nurse administered the subject flu vaccine,
    which was intended for intramuscular administration, to Petitioner’s left deltoid.
    Ex. 1 at 1; Rule 4(c) Report at 2, n. 2-3.
    •   While the vaccine record is from Freiderica Pharmacy & Compounding,
    Petitioner and a coworker recall that the vaccines were administered at their
    workplace’s breakroom. Exs. 13-14.
    5
    I recognize that Petitioner submitted two affidavits herself, as well as one from a coworker with
    recollections concerning the circumstances of their vaccinations in the workplace. Exs. 11, 13-14. These
    affidavits do not address the onset of Petitioner’s shoulder pain, however.
    4
    •   On November 8, 2017, Petitioner left a message for her primary care practice.
    Shawn Fells recorded that “since [Petitioner] received the flu shot in late
    October,” she had been experiencing pain at the injection site and difficulty
    moving her arm, and that she had taken Tylenol and Ibuprofen with no relief.
    Ex. 2 at 20.
    •   The following day, November 9, 2017, a different individual, Nurse Jill Ashley,
    returned the call. Nurse Ashley memorialized in the record pertaining to this
    contact that Petitioner “had no pain in her arm for 2 days after her flu shot, but
    after the 2 days she has had a lot of pain…” Ex. 2 at 20 (emphasis added).
    Nurse Ashley also recorded that Petitioner had “read online that people have
    experienced this after the flu shot” and “discussed [that Petitioner’s pain] may
    or may not be related to inj.” 
    Id.
     Nurse Ashley scheduled an appointment for
    the following Wednesday, November 15, 2017, for the primary care doctor,
    Rhodora Rhagavan, M.D., to assess Petitioner’s shoulder and discuss
    treatment options. 
    Id.
    •   At the November 15, 2017, appointment, Dr. Rhagavan recorded Petitioner’s
    history of “pain in her left arm from flu shot x6 weeks,” despite the application
    of ice, heat, electronic stimulation, and ibuprofen. Ex. 2 at 18. Dr. Rhagavan
    observed that Petitioner had restricted range of motion due to pain. 
    Id.
     Dr.
    Rhagavan recorded that Petitioner’s left arm pain was a “vaccine reaction,” and
    referred her to physical therapy. 
    Id.
    •   Upon starting physical therapy on December 12, 2017, Petitioner reported “left
    upper arm and shoulder pain that began on October 11th after getting her flu
    shot.” Ex. 3 at 153.
    •   Petitioner’s initial course of physical therapy consisted of nine visits. Ex. 3 at
    153-81.6 On January 14, 2018, she self-discharged, planning to follow up with
    Dr. Rhagavan for additional testing and treatment options. Id. at 180-81.
    •   On January 24, 2018, Petitioner followed up with Dr. Raghavan for continued
    pain in her left arm, which “started of [sic?] after receiving a flu vaccination in
    that arm,” and had been present “for about 4 months now.” Ex. 2 at 16.
    Petitioner’s left arm “hurt more than before” despite the non-steroidal anti-
    inflammatory medications (“NSAIDS”) and physical therapy. Id. Dr. Raghavan
    recorded that Petitioner’s pain was “chronic,” ordered an ultrasound,
    administered a Toradol injection, and prescribed Tramadol oral pain
    medications. Id.
    6
    The physical therapy sessions are out of order, but numbered, within Exhibit 5. The sessions were on
    December 12th, 14th, 19th, 21st, 27th, and 28th, 2017; and January 2nd, 4th, and 9th, 2018.
    5
    •   Dr. Raghavan referred Petitioner to a neurologist on January 25th, and
    prescribed gabapentin as a further intervention for her pain on February 1st,
    2018. Ex. 2 at 14-15.
    •   At their February 6, 2018, initial consult, the neurologist Julia McCoy, M.D.,
    recorded:
    “[Petitioner] was in good health until October 11th, when she
    received a standard influenza injection at a local pharmacy. An
    IM injection in the left deltoid produced no immediate pain or
    significant change until the next day when the patient ‘developed
    sharp pains’ notably over the left deltoid with progressive pain in
    the proximal arm with pain on range of motion. The patient was
    given anti-inflammatories which did take the edge off and was
    given physical therapy for nine weeks which was not beneficial.”
    Ex. 2 at 155. Dr. McCoy’s impression was “influenza injection-induced adhesive
    capsulitis.” Id. at 155-57. An EMG nerve conduction study found no evidence
    for Parsonage-Turner syndrome. Id. at 157-60. Dr. McCoy recommended an
    MRI of the left shoulder and further evaluation by orthopedist Martin Siems,
    M.D. Id. at 157.
    •   On February 22, 2018, at their initial consult, Dr. Siems recorded that Petitioner
    had left shoulder pain “since she received a flu shot this year.” Ex. 5 at 26.
    Petitioner’s pain and stiffness had persisted despite “nine weeks of physical
    therapy.” Id. Dr. Siems ordered an MRI to confirm his assessment of adhesive
    capsulitis and to rule out a rotator cuff tear. Id.
    •   The February 28, 2018, MRI did not identify a rotator cuff tear or tendinopathy.
    The findings were consistent with adhesive capsulitis, mild acromioclavicular
    arthrosis, and minimal subacromial and subdeltoid bursitis. Ex. 5 at 57-58.
    •   On March 12, 2018, Dr. Siems manipulated Petitioner’s left shoulder under
    anesthesia. Ex. 6 at 5; see also Ex. 5 at 21-25 (related medical appointments).
    •   Later that day, Petitioner began treatment with a new physical therapist for the
    treatment of “adhesive capsulitis sustained as a result of receiving the flu shot
    5 months ago.” Ex. 3 at 106. She ultimately underwent 40 physical therapy
    sessions through October 10, 2018. Id. at 20-152.
    •   On July 3, 2018, orthopedic surgeon Jonathan Wyatt, M.D., met with Petitioner
    to discuss her left shoulder pain (recorded as being present for “several
    months,”) and plans for further surgical intervention. Ex. 5 at 15-17.
    •   On August 3, 2018, Dr. Wyatt performed a left shoulder arthroscopy with
    capsular release, biceps tenotomy with limited debridement, subacromial
    decompression, and further manipulation of the left shoulder under anesthesia.
    6
    Ex. 5 at 39-41; see also id. at 8-15 and Ex. 12 at 16-18 (follow up appointments
    with Dr. Wyatt).
    •   At their last known follow-up appointment on June 25, 2019, Dr. Wyatt recorded
    that Petitioner’s left shoulder had improved following surgery and physical
    therapy, but she had continued pain and limitations in range of motion. She
    would continue with NSAIDs, topical treatments, and stretching exercises, and
    would follow up with Dr. Wyatt as needed. Ex. 12 at 15-16.
    IV.    Findings of Fact
    I acknowledge that the standard applied to resolving onset for an alleged SIRVA
    is liberal, and will often permit a determination in a petitioner’s favor, especially in the
    absence of fairly contemporaneous and direct statements within the petitioner’s medical
    records to the contrary. However, not every case can be so preponderantly established.
    Ultimately, the resolution of such fact issues involves weighing different items of evidence
    against the overall record.
    Here, Petitioner’s post-vaccination onset claims (which do eventually tend to report
    immediate pain) are offset against a record created very near-in-time to vaccination – and
    this record does not support Petitioner’s claim. Specifically, the second post-vaccination
    record - from the November 9, 2017, telephone encounter with Nurse Ashley - specifically
    refutes the existence of pain for the first two days after vaccination, placing onset instead
    at “after the two days.” Ex. 2 at 20. The record from the day immediately before (the first
    record reporting pain) vaguely references pain “since” the receipt of the vaccine – and
    although this is not inconsistent with an allegation of immediate pain, it is also consistent
    with the second record, which identifies a particular, later onset. Id.
    Thereafter, on November 15, 2017, Petitioner reported a six-week history of
    shoulder pain, which dates back precisely to October 4, 2017. Ex. 2 at 18. However, that
    record does not mention the vaccination, and could represent a more approximate
    timeframe. Compare, e.g., Ex. 2 at 16 (January 24, 2018, history of shoulder pain “for
    about 4 months now,” which would relate back to before vaccination). Other records
    contain a history of shoulder pain either “since” or beginning within the first two days after
    vaccination. However, these were generally created later in time, and contain other
    inconsistencies. See, e.g., Ex. 2 at 20 (dating vaccination in “late” October); Ex. 3 at 153
    (providing that the vaccination occurred on October 11th); Ex. 2 at 155 (providing the same
    incorrect date, and that the vaccination occurred “at a local pharmacy” rather than at
    Petitioner’s workplace).
    7
    Overall, the most contemporaneous and specific record was that created by Nurse
    Ashley, which provides that onset occurred beyond 48 hours after vaccination. Petitioner
    has provided me no reason not to conclude that this medical record is correct, and she
    has not provided “consistent, clear, cogent, and compelling” testimony – or other evidence
    – in rebuttal. Camery v. Sec’y of Health & Human Servs., 
    42 Fed. Cl. 381
    , 391 (1998)
    (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 
    1998 WL 408611
    , at *5
    (Fed. Cl. Spec. Mstr. June 30, 1998). And while other records are consistent with post-
    vaccination pain, they do not merit more weight than a specific and far closer-in-time
    record. Accordingly, there is not preponderance evidence of onset within 48 hours. 
    42 C.F.R. § 100.3
    (a)(I)(C).
    Nevertheless, the record does support onset having occurred shortly after
    vaccination – e.g., within the first 72 hours – and seemingly, all other criteria for a Table
    SIRVA claim. Therefore, Petitioner very likely has a viable non-Table claim. To that end,
    I urge the parties to make one final brief attempt at settlement – as I would anticipate that
    even after transfer, Petitioner’s claim could prove meritorious despite her inability to meet
    one Table element.
    Conclusion
    Petitioner has not preponderantly established that the onset of her shoulder pain
    occurred within 48 hours of vaccination. Accordingly, Petitioner’s Table SIRVA claim is
    dismissed. Petitioner shall file a joint status report addressing her conveyance of a
    revised settlement demand for her off-Table claim, and the parties’ efforts towards
    informal resolution, by no later than Friday, January 14, 2022. If the parties do not
    report progress in their efforts, the matter will likely be transferred out of the SPU.
    IT IS SO ORDERED.
    s/Brian H. Corcoran
    Brian H. Corcoran
    Chief Special Master
    8