Loyd v. Hhs ( 2023 )


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  • Case: 22-1371    Document: 51    Page: 1   Filed: 02/10/2023
    NOTE: This disposition is nonprecedential.
    United States Court of Appeals
    for the Federal Circuit
    ______________________
    TASHA LOYD, PARENT AND NEXT FRIEND OF
    C.L., A MINOR,
    Petitioner-Appellant
    v.
    SECRETARY OF HEALTH AND HUMAN
    SERVICES,
    Respondent-Appellee
    ______________________
    2022-1371
    ______________________
    Appeal from the United States Court of Federal Claims
    in No. 1:16-vv-00811-EGB, Senior Judge Eric G. Bruggink.
    ______________________
    Decided: February 10, 2023
    ______________________
    RICHARD GAGE, Richard Gage, PC, Cheyenne, WY, ar-
    gued for petitioner-appellant.
    TYLER KING, Torts Branch, Civil Division, United
    States Department of Justice, Washington, DC, argued for
    respondent-appellee.   Also represented by BRIAN M.
    BOYNTON, C. SALVATORE D'ALESSIO, TRACI PATTON,
    HEATHER LYNN PEARLMAN.
    ______________________
    Case: 22-1371    Document: 51     Page: 2    Filed: 02/10/2023
    2                                               LOYD   v. HHS
    Before LOURIE, TARANTO, and STOLL, Circuit Judges.
    STOLL, Circuit Judge.
    This is a case brought under the National Childhood
    Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34, as
    amended (the Vaccine Act). Tasha Loyd filed a petition un-
    der the Act on behalf of her minor daughter C.L., alleging
    that the vaccinations C.L. received caused her chronic im-
    mune thrombocytopenic purpura (ITP). The special master
    found that Ms. Loyd had not demonstrated by a preponder-
    ance of the evidence that the vaccines caused C.L.’s chronic
    ITP, and the Court of Federal Claims affirmed. For the
    reasons explained below, we determine that the special
    master did not abuse his discretion in making that finding.
    We thus affirm the decision of the Court of Federal Claims.
    BACKGROUND
    Ms. Loyd’s petition alleged that C.L.’s second dose of
    the pneumococcal conjugate vaccine (PCV or Prevnar®),
    which she received on August 30, 2013, caused C.L.’s
    chronic ITP. 1 C.L.’s medical history, both before and after
    the second dose of the Prevnar vaccine, is relevant to this
    appeal.
    C.L. was born a healthy baby in January 2013. For the
    first several months of her life, C.L. saw her pediatrician,
    Dr. Laura Heimback-Graham, for regular well-child visits
    and received her initial rounds of vaccinations. During and
    after these visits, Ms. Loyd did not report any adverse re-
    actions to these vaccines.
    1  While the petition lists both the Prevnar vaccine
    and the Haemophilus influenzae type b vaccine as alleg-
    edly causing C.L.’s ITP, the evidence before the special
    master, the decisions of the special master and the Court
    of Federal Claims, and the parties’ briefing focus only on
    the Prevnar vaccine. See, e.g., Appellee’s Br. 11 n.1.
    Case: 22-1371     Document: 51     Page: 3    Filed: 02/10/2023
    LOYD    v. HHS                                              3
    On August 30, 2013, C.L. returned to Dr. Heimback-
    Graham and received, among other vaccines, the second
    dose of the Prevnar vaccine. At this visit, Ms. Loyd re-
    ported that C.L. had recently been fussier than normal and
    had white patches on her tongue. Dr. Heimback-Graham
    diagnosed C.L. with thrush and prescribed an antifungal
    medication to address these concerns. The medical records
    from this visit indicate that Ms. Loyd did not report any
    further concerns or complaints.
    Over three months after her second dose of the Prevnar
    vaccine, on December 2, 2013, C.L. returned to Dr. Heim-
    back-Graham to treat an infected earlobe piercing. C.L.
    visited Dr. Heimback-Graham again in January 2014, over
    four months after the vaccine, to treat fever, cough, and
    congestion. Medical records from both visits indicate that
    no other health complaints were raised, and physical ex-
    aminations of C.L. were otherwise normal.
    C.L. returned to her pediatrician for her one-year well-
    child visit on February 3, 2014. Ms. Loyd reported that she
    did not want C.L. to receive her scheduled vaccinations be-
    cause C.L. was allegedly “not herself” for some time after
    receiving her previous vaccinations, although the medical
    records from this visit do not provide any further detail.
    J.A. 94. At this visit, Dr. Heimback-Graham performed a
    complete blood test (CBC), which revealed that C.L. had
    normal levels of blood platelets (specifically, 340,000/µL). 2
    2   The medical literature submitted as evidence be-
    fore the special master explains that normal blood platelet
    levels in infants range from about 200,000 to 475,000/µL.
    Loyd v. Sec’y of Health & Hum. Servs., No. 16-811V, 
    2021 WL 2708941
    , at *2 n.3 (Ct. Cl. May 20, 2021) (citing K. Pa-
    gana & T. Pagana, Mosby’s Manual of Diagnostic and La-
    boratory Tests 156, 362 (6th ed. 2018)). Physicians can
    diagnose vaccine-associated ITP when a child’s platelet lev-
    els measure below 100,000/µL. 
    Id.
     (citing V. Cecinati et al.,
    Case: 22-1371    Document: 51      Page: 4    Filed: 02/10/2023
    4                                                LOYD   v. HHS
    Six weeks after this visit, in March 2014, C.L. again visited
    her pediatrician to treat a fever. Like the multiple previous
    visits, the medical records state that no other concerns or
    complaints were raised.
    On June 2, 2014—approximately nine months after re-
    ceiving the second dose of the Prevnar vaccine—C.L. re-
    turned again to see Dr. Heimback-Graham. The medical
    records from this visit note excessive bruising, a tell-tale
    symptom of ITP, for the first time. See J.A. 279–81
    (Ms. Loyd reporting a two-week history of bruising).
    Dr. Heimback-Graham ordered two CBC tests. Unlike the
    February 2014 CBC test, the results from these two tests
    revealed that C.L.’s blood platelet counts were low (specif-
    ically, 34,000/µL and 23,000/µL). Dr. Heimback-Graham
    referred C.L. to a pediatric hematologist, who diagnosed
    C.L. with acute ITP that same day. Since her diagnosis,
    C.L. has continued to receive treatment for her ITP—which
    was classified as chronic ITP in 2015—and her blood plate-
    let levels have been repeatedly tested and have remained
    consistently low.
    On July 8, 2016, Ms. Loyd filed a Vaccine Act petition
    on behalf of C.L. The special master assigned to the case
    held a hearing and ultimately found, among other things,
    that the onset of C.L.’s ITP did not occur until, at the ear-
    liest, May 2014, the first time at which her medical records
    indicate symptoms of ITP. Loyd v. Sec’y of Health & Hum.
    Servs., No. 16-811V, 
    2021 WL 2708941
     (Ct. Cl. May 20,
    2021) (“Special Master Decision”). In large part because of
    the length of time between the allegedly causative vaccina-
    tion and this onset date—eight to nine months—the special
    master found that the record did not establish that C.L.’s
    chronic ITP was more likely than not caused by the
    Vaccine Administration and the Development of Immune
    Thrombocytopenic Purpura in Children, 9 HUM. VACCINES
    & IMMUNOTHERAPEUTICS 1, 2 (2013)).
    Case: 22-1371     Document: 51      Page: 5    Filed: 02/10/2023
    LOYD   v. HHS                                                5
    Prevnar vaccine. Id. at *28. Ms. Loyd moved for review of
    the special master’s decision in the Court of Federal
    Claims. That court determined that the special master’s
    decision was neither arbitrary nor capricious and thus af-
    firmed. J.A. 46–69.
    Ms. Loyd timely appealed, and we have jurisdiction un-
    der 
    28 U.S.C. § 1295
    (a)(3) and 42 U.S.C. § 300aa-12(f).
    DISCUSSION
    Petitioners can qualify for compensation under the
    Vaccine Act in two ways. First, “if the petitioner can estab-
    lish an injury listed on the Vaccine Act Injury Table that
    occurred after the administration of a designated vaccine
    within a designated period of time (“Table cases”), then
    causation is presumed.” Boatmon v. Sec’y of Health &
    Hum. Servs., 
    941 F.3d 1351
    , 1354 (Fed. Cir. 2019). Second,
    if a petitioner claims an injury not listed on the table (i.e.,
    in an “off-Table” case), then she “must prove, by a prepon-
    derance of the evidence, that the vaccine was the cause-in-
    fact of the claimed injury.” Id.; 42 U.S.C. §§ 300aa-
    11(c)(1)(C)(ii)(I), 300aa-13(a)(1).
    To prove causation in an off-Table case, the petitioner
    must “show by preponderant evidence that the vaccination
    brought about [the] injury” by establishing each of the
    three requirements set forth in Althen v. Secretary of
    Health & Human Services, 
    418 F.3d 1274
    , 1278 (Fed. Cir.
    2005): (1) a medical theory causally connecting the vac-
    cination and the injury; (2) a logical sequence of cause and
    effect showing that the vaccination was the reason for the
    injury; and (3) a showing of a proximate temporal relation-
    ship between vaccination and injury. Moberly v. Sec’y of
    Health & Hum. Servs., 
    592 F.3d 1315
    , 1321–22 (Fed. Cir.
    2010) (quoting Althen, 
    418 F.3d at 1278
    ). If a petitioner
    has satisfied all three Althen prongs by a preponderance of
    the evidence, she is entitled to compensation unless the
    government shows “by a preponderance of the evidence[]
    that the injury was in fact caused by factors unrelated to
    Case: 22-1371     Document: 51     Page: 6    Filed: 02/10/2023
    6                                                 LOYD   v. HHS
    the vaccine.” Althen, 
    418 F.3d at 1278
     (quoting Knudsen
    v. Sec’y of Health & Hum. Servs., 
    35 F.3d 543
    , 547
    (Fed. Cir. 1994)).
    Under the Vaccine Act, the Court of Federal Claims re-
    views a special master’s decision to determine whether it is
    “arbitrary, capricious, an abuse of discretion, or otherwise
    not in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B).
    Because we review de novo the Court of Federal Claims’
    decision regarding a special master’s decision to deny enti-
    tlement to compensation under the Vaccine Act, we effec-
    tively “perform[] the same task as the Court of Federal
    Claims and determine[] anew whether the special master’s
    findings were arbitrary or capricious.” Lampe v. Sec’y of
    Health & Hum. Servs., 
    219 F.3d 1357
    , 1360 (Fed. Cir.
    2000). We do “not reweigh the factual evidence, assess
    whether the special master correctly evaluated the evi-
    dence, or examine the probative value of the evidence or
    the credibility of the witnesses—these are all matters
    within the purview of the fact finder.” Porter v. Sec’y of
    Health & Hum. Servs., 
    663 F.3d 1242
    , 1249 (Fed. Cir.
    2011). In general, reversible error is “extremely difficult to
    demonstrate” if the special master “has considered the rel-
    evant evidence of record, drawn plausible inferences[,] and
    articulated a rational basis for the decision.” Hines v. Sec’y
    of Health & Hum. Servs., 
    940 F.2d 1518
    , 1528 (Fed. Cir.
    1991).
    On appeal, Ms. Loyd makes two arguments: (1) that
    the special master’s finding that the onset of C.L.’s ITP did
    not occur until, at the earliest, May 2014 was arbitrary and
    capricious, Appellant’s Br. 25–31; and (2) that the special
    master applied the wrong legal standard by requiring the
    petitioner to prove the first Althen prong by a preponder-
    ance of the evidence, 
    id.
     at 31–41.
    Regarding Ms. Loyd’s first argument, the special mas-
    ter, “[a]fter considering the parties’ respective positions
    and supporting evidence,” found “that the onset of C.L.’s
    Case: 22-1371     Document: 51     Page: 7    Filed: 02/10/2023
    LOYD    v. HHS                                              7
    chronic ITP more likely than not occurred in May 2014.”
    Special Master Decision at *25. In making this determina-
    tion, the special master explicitly considered all of the evi-
    dence provided by Ms. Loyd. Specifically, he considered
    and discussed, among other things, Ms. Loyd’s own testi-
    mony, 
    id.
     at *5–7; photographs taken by Ms. Loyd that al-
    legedly showed bruising on C.L. in the fall of 2013, 3 id.
    at *16; a prescriber reference for Prevnar, which listed
    warnings for providers, id. at *8; reports on the Vaccine
    Adverse Events Reporting System listing adverse reactions
    to the Prevnar vaccine, id.; and a letter from Dr. Berger,
    one of C.L.’s treating physicians who did not testify at the
    hearing, id. at *15–16. Finally, the special master dis-
    cussed at particular length the testimony of petitioner’s ex-
    pert, Dr. Gershwin, who presented his medical theory at
    the hearing that the Prevnar vaccine could have caused
    C.L.’s chronic ITP through a concept called “molecular
    mimicry.” Id. at *7–11.
    The special master also considered the evidence sub-
    mitted by the government, such as many pieces of medical
    literature, including large scale epidemiological studies
    that showed no significant link between Prevnar and ITP,
    id. at *13–15; C.L.’s medical record itself, which did not
    have any indication of ITP symptoms until, at the earliest,
    two to three weeks before June 2, 2014, id. at *1–5; and the
    testimony from the government’s two medical experts,
    Dr. Strouse and Dr. MacGinnitie, id. at *11–15. The gov-
    ernment’s experts uniformly testified that Dr. Gershwin’s
    molecular mimicry theory was unlikely. In Dr. Strouse and
    3   The special master noted that several of these pho-
    tographs were neither authenticated nor had any metadata
    indicating the date on which they were taken. Despite
    these authentication deficiencies, the special master con-
    sidered them as part of his weighing of the evidence. Spe-
    cial Master Decision at *16, *27 n.27.
    Case: 22-1371    Document: 51      Page: 8    Filed: 02/10/2023
    8                                                LOYD   v. HHS
    Dr. MacGinnitie’s view, this theory was unlikely, in part
    because it had only been used to connect other, non-Prev-
    nar vaccines to ITP. It was also unlikely, in their view,
    because C.L.’s medical record—which showed normal
    platelet counts in February 2014, five months after receiv-
    ing the vaccine—controverted Dr. Gershwin’s theory that
    the onset of C.L.’s ITP occurred shortly after vaccination.
    The government’s experts also testified regarding the pho-
    tographs submitted by Ms. Loyd. The two experts agreed
    that while the photographs did show “some evidence of
    bruising,” they did not show petechiae, a unique type of
    bruising associated with ITP. Id. at *11–12, *15. The ex-
    perts explained that the photographs instead showed
    bruising that was “typical” and not unusual for a young
    child of C.L.’s age. Id.
    For each piece of evidence presented, both by Ms. Loyd
    and by the government, the special master discussed its
    relevance to the case, its credibility, and its strength; in
    other words, the special master weighed each piece of evi-
    dence. On balance, the special master found that it was
    more likely than not that the onset of C.L.’s chronic ITP
    was no earlier than May 2014. Id. at *24–27. The special
    master further explained that it was undisputed that an
    onset date of May 2014—more than nine months after C.L.
    received the second dose of Prevnar—was too remote from
    the date of vaccination to conclude that Prevnar caused
    C.L.’s condition. Id. at *28 (noting that “Dr. Gershwin . . .
    conceded that an onset of five to ten months post-vaccina-
    tion would not be medically acceptable for purposes of prov-
    ing vaccine causation”); J.A. 54 (Court of Federal Claims
    noting same concession). Accordingly, the special master
    determined that the petitioner had not met her burden to
    prove Althen prong three, which requires a proximate tem-
    poral relationship between the vaccination and the injury.
    In view of the special master’s analysis and the evi-
    dence of record, we conclude that this factual finding—that
    C.L.’s chronic ITP more likely than not began no earlier
    Case: 22-1371     Document: 51      Page: 9    Filed: 02/10/2023
    LOYD   v. HHS                                                9
    than May 2014—was not arbitrary or capricious. The spe-
    cial master’s factfinding is supported by the evidence of rec-
    ord, including, among other things, C.L.’s medical records,
    which did not note any symptoms of ITP until two to three
    weeks before her June 2, 2014, medical visit. In addition,
    the special master found credible the testimony of the gov-
    ernment’s experts that the Prevnar vaccine has not been
    linked to ITP and that Dr. Gershwin’s proposed medical
    theory was unlikely. We do not see that the special mas-
    ter’s factfinding on this point was unreasonable. In other
    words, “the special master has considered the relevant ev-
    idence of record, drawn plausible inferences[,] and articu-
    lated a rational basis for the decision,” Hines, 
    940 F.2d at 1528
    , and thus his finding is not arbitrary or capricious.
    On appeal, Ms. Loyd argues that certain evidence con-
    flicts with the special master’s ultimate conclusion. Specif-
    ically, Ms. Loyd highlights the photos she presented
    showing bruising on C.L. and Dr. Gershwin’s testimony
    that he once treated a patient whose platelet levels would
    vary when presented with poison oak, a phenomenon which
    could potentially explain C.L.’s normal platelet levels in
    February 2014. Appellant’s Br. 27–29. First, to the extent
    that there are conflicts in the testimonial evidence pre-
    sented at the hearing, those conflicts were for the special
    master to resolve. See Lampe, 
    219 F.3d at 1362
     (A special
    master’s “assessments of the credibility of the witnesses . . .
    are virtually unchallengeable on appeal.”). Second, at bot-
    tom, Ms. Loyd’s appellate argument on this issue essen-
    tially asks us to reweigh the evidence, something we cannot
    do under the arbitrary and capricious standard of review.
    See Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm
    Mut. Auto. Ins. Co., 
    463 U.S. 29
    , 43 (1983); see also Porter,
    
    663 F.3d at 1249
     (“[E]valuat[ing] the evidence, . . . [and]
    examin[ing] the probative value of the evidence or the cred-
    ibility of the witnesses . . . are all matters within the pur-
    view of the fact finder.”). Because the special master’s fact
    finding is “based on evidence in the record that is not
    Case: 22-1371    Document: 51      Page: 10    Filed: 02/10/2023
    10                                                LOYD   v. HHS
    wholly implausible, we are compelled to uphold that find-
    ing as not being arbitrary or capricious.” Cedillo v. Sec’y of
    Health & Hum. Servs., 
    617 F.3d 1328
    , 1338 (Fed. Cir. 2010)
    (cleaned up). And given Dr. Gershwin’s concession that
    this date precludes a finding of causation under Althen
    prong three, we thus affirm the special master’s determi-
    nation that the petitioner has not shown that each of the
    Althen prongs has been met.
    Ms. Loyd also argues on appeal that the special master
    applied an improper legal standard in his analysis of Al-
    then prong one. Appellant’s Br. 31–41. As explained
    above, however, our affirmance of the special master’s fact
    finding that the onset of C.L.’s ITP was no earlier than
    May 2014 resolves Althen prong three against the peti-
    tioner. Accordingly, we need not and do not reach this ar-
    gument regarding Althen prong one.
    CONCLUSION
    Like the special master, we “have great sympathy . . .
    for [Ms. Loyd’s] desire to ascertain a possible cause for
    C.L.’s medical distress.” Special Master Decision at *32.
    The special master’s comprehensive decision, however, was
    based on a thorough examination of the large body of evi-
    dence submitted in this case. We agree with the Court of
    Federal Claims that the special master’s weighing of that
    evidence was neither arbitrary nor capricious. We there-
    fore affirm.
    AFFIRMED
    COSTS
    No costs.