Olson v. Hhs ( 2018 )


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  •        NOTE: This disposition is nonprecedential.
    United States Court of Appeals
    for the Federal Circuit
    ______________________
    CAROLYNNE OLSON,
    Petitioner-Appellant
    v.
    SECRETARY OF HEALTH AND HUMAN
    SERVICES,
    Respondent-Appellee
    ______________________
    2018-1467
    ______________________
    Appeal from the United States Court of Federal
    Claims in No. 1:13-vv-00439-EJD, Senior Judge Edward
    J. Damich.
    ______________________
    Decided: December 21, 2018
    ______________________
    MITCHEL OLSON, Law Office of Mitchel J. Olson, J.D.,
    M.D., Encinitas, CA, for petitioner-appellant.
    JENNIFER LEIGH REYNAUD, Vaccine/Torts Branch,
    Civil Division, United States Department of Justice,
    Washington, DC, for respondent-appellee. Also repre-
    sented by ALEXIS B. BABCOCK, C. SALVATORE D'ALESSIO,
    CATHARINE E. REEVES, JOSEPH H. HUNT.
    ______________________
    2                 OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.
    Before WALLACH, TARANTO, and HUGHES, Circuit Judges.
    PER CURIAM.
    Appellant Carolynne Olson sued Appellee Secretary of
    Health and Human Services (“the Government”) for
    compensation under the National Childhood Vaccine
    Injury Act of 1986 (“Vaccine Act”). See Pub. L. No. 99-
    660, 100 Stat. 3755 (codified as amended at 42 U.S.C.
    §§ 300aa-2–33 (2012)). Ms. Olson alleges that she devel-
    oped rheumatoid arthritis (“RA”) 1 as a result of receiving
    the Gardasil® 2 vaccine for HPV. A Special Master of the
    U.S. Court of Federal Claims found that, inter alia, Ms.
    Olson “failed to carry her burden in establishing causa-
    tion,” such that Ms. Olson was not entitled to compensa-
    tion. Olson I, 
    2017 WL 3624085
    , at *1. Ms. Olson filed a
    motion for review in the Court of Federal Claims, which
    was denied. See Olson v. Sec’y of Health & Human Servs.
    (Olson II), 
    135 Fed. Cl. 670
    , 672 (Fed. Cl. 2017); see also
    J.A. 1 (Judgment).
    Ms. Olson appeals. We have jurisdiction pursuant to
    28 U.S.C. § 1295(a)(3) (2012). We affirm.
    1   “RA is a long-term autoimmune condition mainly
    affecting the joints.” Olson v. Sec’y of Health & Human
    Servs. (Olson I), No. 13-439V, 
    2017 WL 3624085
    , at *5
    (Fed. Cl. July 14, 2017). RA “involves an autoimmune
    attack on the synovial membranes of the joints, causing
    inflammation and later erosion and destruction of joint
    surfaces, along with deformity of affected joints, fingers,
    or toes. It can also cause complications in the lungs,
    kidneys, and other organs.”        
    Id. (citing, inter
    alia,
    J.A. 654–59 (providing a scientific article on RA)).
    2   Gardasil is the tradename of a vaccine that inocu-
    lates individuals against human papillomavirus (“HPV”).
    See J.A. 420.
    OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.                     3
    BACKGROUND
    On July 1, 2010, Ms. Olson received the HPV vaccina-
    tion from her gynecologist. Olson 
    II, 135 Fed. Cl. at 672
    . 3
    Ms. Olson sought the vaccine “to treat warts after learn-
    ing from her daughter’s dermatologist” that the vaccine
    “could be effective” in this regard. 
    Id. At the
    time of the
    vaccination, she was fifty-two years old, and therefore not
    within the target age group for the vaccine. 
    Id. She was
    also being treated for the following medical conditions:
    hypothyroidism, vitamin D deficiency, osteochondroma,
    an Achilles tendon rupture, anemia, asthma, sinus pres-
    sure, facial pain, lung congestion, and chronic sinusi-
    tis. 
    Id. Within two
    weeks of being administered the vaccine,
    Ms. Olson began experiencing a burning sensation in both
    of her hands. 
    Id. The first
    medical documentation of her
    symptoms was made by her gynecologist on December 13,
    2010, almost five and a half months post-vaccination. 
    Id. Ms. Olson
    recounted to her gynecologist that she had been
    experiencing persistent “knuckle enlargement with pain”
    since receiving the HPV vaccine, and her gynecologist
    referred Ms. Olson to a rheumatologist for further treat-
    ment. 
    Id. (internal quotation
    marks, brackets, and cita-
    tion omitted).
    On February 22, 2011, the rheumatologist document-
    ed that Ms. Olson’s “clinical presentation was highly
    suspicious for reactive arthritis[4].” 
    Id. (internal quotation
    3   Because the parties do not dispute the Court of
    Federal Claims’ recitation of the facts, we cite to the
    Court of Federal Claims’ opinion for the background. See
    Olson 
    II, 135 Fed. Cl. at 672
    –73. See generally Appel-
    lant’s Br.; Appellee’s Br.
    4   “Reactive arthritis is not [RA]. Reactive arthritis
    is joint pain and swelling triggered by an infection in
    4                  OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.
    marks, brackets, and citation omitted). He, therefore,
    ordered laboratory testing, the results of which revealed
    biological indicators “of a prior resolved infection con-
    sistent with reactive arthritis.” 
    Id. The results
    were
    negative, however, for two indicators “that are strongly
    associated with RA.” 
    Id. (citation omitted).
    Ms. Olson
    continued seeing the rheumatologist until late 2013. 
    Id. For most
    of the time Ms. Olson saw the rheumatolo-
    gist, she continued experiencing the symptoms noted
    above, though she would occasionally experience “only
    minor joint pain.” 
    Id. When the
    symptoms worsened,
    however, Ms. Olson began treatment with a second rheu-
    matologist, Dr. Gregory Middleton, beginning in Septem-
    ber 2013. 
    Id. Dr. Middleton
    diagnosed Ms. Olson with
    seronegative RA, 5 and “attributed the RA to [Ms. Olson’s]
    immune system over-reaction from her 2010 HPV vac-
    cine.” 
    Id. (internal quotation
    marks and citation omitted).
    DISCUSSION
    I. Standard of Review and Legal Standard
    “We review an appeal from the Court of Federal
    Claims in a Vaccine Act case de novo, applying the same
    standard of review as the Court of Federal Claims applied
    in reviewing the special master’s decision.” Oliver v. Sec’y
    of Health & Human Servs., 
    900 F.3d 1357
    , 1360 (Fed. Cir.
    2018) (internal quotation marks, brackets, and citation
    omitted).   “Although we review legal determinations
    without deference, we review the special master’s factual
    findings under the arbitrary and capricious standard.” 
    Id. another part
    of the body.” Olson 
    II, 135 Fed. Cl. at 672
    n.5 (internal quotation marks and citation omitted).
    5   “Seronegative RA is a diagnosis of RA despite the
    absence in the blood of the two . . . markers . . . that are
    strongly associated with RA.” Olson 
    II, 135 Fed. Cl. at 672
    (internal quotation marks omitted).
    OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.                     5
    (internal quotation marks and citation omitted). “This
    standard is uniquely deferential and difficult for an
    appellant to satisfy with respect to any issue, but particu-
    larly with respect to an issue that turns on the weighing
    of evidence by the trier of fact.” 
    Id. (internal quotation
    marks and citation omitted). If “the special master’s
    conclusion is based on evidence in the record that is not
    wholly implausible, we are compelled to uphold that
    finding as not being arbitrary or capricious.” 
    Id. at 1360–
    61 (internal quotation marks and citation omitted); see
    Hines ex rel. Sevier v. Sec’y of the Dep’t of Health & Hu-
    man Servs., 
    940 F.2d 1518
    , 1528 (Fed. Cir. 1991) (“If the
    special master has considered the relevant evidence of
    record, drawn plausible inferences[,] and articulated a
    rational basis for the decision, reversible error will be
    extremely difficult to demonstrate.”).
    “The Vaccine Act distinguishes between . . . ‘Table in-
    juries,’ for which causation is presumed when a designat-
    ed condition follows the administration of a designated
    vaccine within a designated period of time, and all other
    injuries alleged to be caused by a vaccine, [i.e.,] ‘off-Table
    injuries,’ for which causation must be proved . . . .”
    Moberly ex rel. Moberly v. Sec’y of Health & Human
    Servs., 
    592 F.3d 1315
    , 1321 (Fed. Cir. 2010) (citations
    omitted); see 42 U.S.C. § 300aa-14 (Vaccine Injury Table).
    Where, as here, a petitioner alleges an off-Table injury,
    “the petitioner’s ‘burden is to show by preponderant
    evidence’ each of the requirements set forth in Althen v.
    Secretary of Health and Human Services (‘the Althen
    prongs’)” for causation. 
    Oliver, 900 F.3d at 1361
    (quoting
    
    418 F.3d 1274
    , 1278 (Fed. Cir. 2005)). The Althen prongs
    are: “(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 rela-
    tionship between vaccination and injury.” 
    Althen, 418 F.3d at 1278
    . “If the petitioner satisfies this burden, she
    6                 OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.
    is entitled to recover unless the Government shows, also
    by a preponderance of evidence, that the injury was in
    fact caused by factors unrelated to the vaccine.” 
    Oliver, 900 F.3d at 1361
    (internal quotation marks, brackets, and
    citation omitted).
    We have specified that, with respect to Althen prong
    one, “a paucity of medical literature supporting a particu-
    lar theory of causation cannot serve as a bar to recovery.”
    Andreu ex rel. Andreu v. Sec’y of Health & Human Servs.,
    
    569 F.3d 1367
    , 1379 (Fed. Cir. 2009) (internal quotation
    marks, brackets, and citations omitted). Accordingly,
    even a possible link between a vaccine and an injury,
    “hitherto unproven in medicine,” can be sufficient for a
    finding of causation. 
    Althen, 418 F.3d at 1280
    . In this
    regard, we require “a reputable medical theory,” Pafford v.
    Sec’y of Health & Human Servs., 
    451 F.3d 1352
    , 1355
    (Fed. Cir. 2006) (emphasis added) (citation omitted),
    providing that the vaccine in question “can cause” the
    injury suffered, Capizzano v. Sec’y of Health & Human
    Servs., 
    440 F.3d 1317
    , 1326 (Fed. Cir. 2006) (citation
    omitted); see Broekelschen v. Sec’y of Health & Human
    Servs., 
    618 F.3d 1339
    , 1345 (Fed. Cir. 2010) (providing the
    explanation simply must be “legally probable, not medi-
    cally or scientifically certain” (internal quotation marks
    and citation omitted)).
    II. Ms. Olson Has Not Demonstrated Causation Because
    She Did Not Meet Her Burden of Providing a Medical
    Theory Causally Connecting the HPV Vaccination and
    Her RA
    The Special Master concluded that, inter alia,
    Ms. Olson failed to meet her burden to show “the HPV
    vaccine could cause RA.” Olson I, 
    2017 WL 3624085
    ,
    at *19. Specifically, the Special Master determined that
    Ms. Olson’s “causation theory is wholly dependent on the
    OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.                   7
    vaccine’s adjuvant[6] causing her RA, but reliable science
    does not corroborate its alleged potential to initiate a
    pathogenic[7] sequence. Moreover, [Ms. Olson’s] medical
    history does not demonstrate her theory in action.” 
    Id. at *1.
    Ms. Olson argues, inter alia, the Special Master
    acted arbitrarily and capriciously by making unsupported
    findings under Althen prong one. See Appellant’s Br. 25–
    30, 33–41, 44–45. We disagree with Ms. Olson.
    The Special Master made plausible findings based on
    the record under Althen prong one. Ms. Olson’s theory of
    how the HPV vaccine caused her RA involved (1) her
    history of inflammatory lung conditions, see 
    id. at 19,
    and
    (2) an adjuvant in the vaccine called “alum,” see 
    id. at 21–
    22. Essentially, Ms. Olson claims that her inflammatory
    lung conditions predisposed her to developing RA, see 
    id. at 19–20;
    see also J.A. 100–15 (testimony of Dr. Middle-
    ton), 354–56 (declaration of Dr. Middleton), and the
    introduction of alum into her body via the HPV vaccine
    stimulated the condition’s onset, see Appellant’s Br. 21–
    22; see also J.A. 115–21 (testimony of Dr. Middleton),
    358–62 (declaration of Dr. Middleton). Following a thor-
    ough recitation of record evidence, see Olson I, 
    2017 WL 3624085
    , at *1–14, the Special Master found “[a] few
    overarching aspects of [Ms. Olson’s] theory [to be] medi-
    6    “An adjuvant is a substance that aids another,
    such as an auxiliary remedy. In this case, the adjuvant
    boosts the immune system to make more antibodies with
    the result that the vaccine is more effective and long-
    lasting.” Olson 
    II, 135 Fed. Cl. at 673
    n.6 (internal quota-
    tion marks and citation omitted).
    7   “Pathogenic means ‘causing disease or morbid
    symptoms.’” Sumner v. Sec’y of Health & Human Servs.,
    No. 99-946V, 
    2015 WL 5173644
    , at *11 n.28 (Fed. Cl. Aug.
    13, 2015) (quoting Pathogenic, Dorland’s Illustrated
    Medical Dictionary (32d ed. 2012)).
    8                  OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.
    cally or scientifically sound,” 
    id. at *20.
    For example, the
    Special Master noted that “[Ms. Olson] has offered per-
    suasive evidence in support of her contention that persis-
    tent lung inflammation is often associated with RA,” and
    her explanation for why was “logical and scientifically
    reliable.” 
    Id. The Special
    Master also remarked that Ms.
    Olson “offer[ed] trustworthy articles exploring the not-
    fully-understood processes by which adjuvants like alum
    help stimulate the innate immune system,” and estab-
    lished that certain immune system protein complexes and
    cell secretions “play some role in the process of encourag-
    ing the unchecked inflammation that is so integral to RA’s
    development.” 
    Id. However, the
    Special Master found that Ms. Olson’s
    specific theory of causation failed to reputably show that
    the HPV vaccine can cause RA. See 
    id. at *19–22.
    With
    regard to the first facet of Ms. Olson’s theory, the Special
    Master found that Ms. Olson “relie[d] on science that is
    ultimately inapposite to the present context.” 
    Id. at *21.
    Specifically, Ms. Olson adduced evidence that specific
    antibodies result from the process by which inflammatory
    lung conditions increase an individual’s risk of RA. See
    id.; see also J.A. 111 (stating, by Dr. Middleton, that “anti-
    citrullinated protein antibod[ies]” (“ACPAs”) are indica-
    tive of inflammatory lung conditions that increase an
    individual’s risk of RA, and are “present in 70 percent of
    patients with [RA]”). Yet, test results showed that ACPAs
    were not present in Ms. Olson, see J.A. 351 (stating, in Dr.
    Middleton’s supplemental expert report, that Ms. Olson’s
    ACPA levels “have been negative”), and the Special Mas-
    ter concluded that, “therefore[,] she cannot credibly pro-
    pose a theory involving a process that she cannot also
    establish occurred to her,” Olson I, 
    2017 WL 3624085
    , at
    *21. The Special Master additionally determined that
    this finding “impacts [Ms. Olson]’s argument that an
    individual with chronic lung infections, due to asthma or
    other respiratory ailments, is susceptible to a vaccine
    OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.                    9
    trigger, since the literature discussing the lung as an
    initiatory situs for RA largely depends on [the process by
    which ACPAs are produced] occurring there first.” Id.; see
    J.A. 575–76 (discussing the process that produces an
    ACPA response).
    With regard to the second facet of Ms. Olson’s theory,
    the Special Master discerned that alum was “the sole
    HPV [vaccine] component implicated,” and “[i]t was
    therefore critically important that [Ms. Olson] marshal
    reliable scientific or medical evidence suggesting that
    alum could precipitate RA or some other comparable
    autoimmune disease.” 
    Id. at *20.
    However, the Special
    Master found that “the literature [Ms. Olson] offered—the
    most scientifically-reliable items of which were studies
    aimed at understanding how alum performs as a stimula-
    tory actor in the immune process—[did] not do this.” 
    Id. (citing, inter
    alia, J.A. 491–502 (investigating, in a scien-
    tific article on adjuvant activity, how alum stimulates the
    immune system), 503–10 (similar)). Ms. Olson’s evidence
    that alum stimulates protein complexes associated with
    RA was deemed inadequate by the Special Master to show
    a possible causal relationship between alum and RA, see
    J.A. 496 (concluding, in a scientific article, that alum
    functions as an adjuvant by stimulating specific protein
    complexes that were claimed by Dr. Middleton to play a
    role in RA); see also J.A. 360–62 (discussing, in Dr. Mid-
    dleton’s supplemental expert report, these protein com-
    plexes’ role in RA), particularly given “[t]he fact that
    many vaccines also contain alum but have not been
    implicated in RA or other autoimmune conditions,” Olson
    I, 
    2017 WL 3624085
    , at *21. The Special Master, there-
    fore, determined that the relevant record evidence merely
    “explore[d] in detail [the] known fact[] that alum is an
    effective adjuvant,” and “d[id] not permit the broader
    conclusion that [Ms. Olson] urges: that alum can be
    pathogenic—and indeed none of [Ms. Olson]’s offered
    literature so proposes.” 
    Id. (footnote omitted).
    10                 OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.
    Ms. Olson’s counterarguments are unavailing. First,
    Ms. Olson asserts that the Special Master applied an
    incorrect legal standard under Althen prong one. See
    Appellant’s Br. 16–17. Specifically, Ms. Olson argues that
    the Special Master “erred in requiring prong one proof of
    probability rather than plausibility.” 
    Id. at 16
    (emphases
    added) (formatting modified). Throughout the Special
    Master’s analysis of the evidence, he correctly applied the
    law of Althen prong one. The Special Master surveyed the
    record to determine whether Ms. Olson’s theory was
    medically reputable, see Olson I, 
    2017 WL 3624085
    , at
    *19–22; see also 
    Pafford, 451 F.3d at 1355
    –56 (holding
    that a special master correctly applied Althen prong one
    in requiring a petitioner to “provide a reputable medical
    theory causally connecting the vaccination and the injury”
    (emphasis added) (citation omitted)), and at no point
    demanded anything but a showing that Ms. Olson’s
    theory was possibly true in light of the marshaled evi-
    dence, see Olson I, 
    2017 WL 3624085
    , at *19–22; see also
    
    Capizzano, 440 F.3d at 1326
    (concluding that “the first
    prong of the Althen . . . test was satisfied by the finding
    that the . . . vaccine can cause [the injury]” (emphasis
    added) (citation omitted)). For example, in his determina-
    tions that Ms. Olson’s assertions were inadequately
    supported, the Special Master stated that, inter alia, the
    assertions were “speculative” and that “[r]eliable scientific
    support [wa]s lacking.” Olson I, 
    2017 WL 3624085
    , at
    *20.
    Second, Ms. Olson contends that the Special Master
    improperly increased her evidentiary burden “by requir-
    ing the testimony of an immunologist.” Appellant’s Br.
    13. In assessing the evidence provided by Dr. Middleton,
    the Special Master observed that, “though qualified to
    testify about RA generally and its possible etiology, [Dr.
    Middleton] lacked the specialized immunologic grounding
    necessary to explain and defend in a persuasive manner
    the theory articulated in this case, given that theory’s
    OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.                  11
    dependency on complex immune system processes.” Olson
    I, 
    2017 WL 3624085
    , at *21; see 
    id. at *6
    (stating Dr.
    Middleton’s qualifications), *8 n.13 (noting “Dr. Middle-
    ton’s lack of particularized expertise on the topic of im-
    munology”).     Special masters “are entitled—indeed,
    expected—to make determinations as to the reliability of
    the evidence presented to them and, if appropriate, as to
    the credibility of the persons presenting that evidence.”
    
    Moberly, 592 F.3d at 1326
    . While special masters may
    not “cloak the application of an erroneous legal standard
    in the guise of a credibility determination,” 
    Andreu, 569 F.3d at 1379
    , here, the Special Master did no such thing.
    The Special Master’s assessment of Dr. Middleton’s
    credibility was appropriate given the former’s role as fact
    finder, and tracks with Dr. Middleton’s express acknowl-
    edgement of the limitations to his expertise when discuss-
    ing alum and its potential immune system effects, see
    J.A. 165 (“I am testifying here as a clinical rheumatolo-
    gist, not as a vaccine expert.”), and the fact that “Dr.
    Middleton did not even begin to see [Ms.] Olson until
    three years from [the] date of her . . . vaccination,” Olson
    I, 
    2017 WL 3624085
    , at *21. The Special Master did not
    require evidence from an immunologist, but rather
    properly evaluated Dr. Middleton’s individual competence
    to opine on the matters at issue. See 
    Moberly, 592 F.3d at 1325
    –26 (“Assessments as to the reliability of expert
    testimony often turn on credibility determinations, par-
    ticularly in cases . . . where there is little supporting
    evidence for the expert’s opinion.”). Thus, Ms. Olson
    failed to meet her burden to demonstrate causation under
    Althen prong one. 8
    8    We need not address the Special Master’s findings
    with respect the remaining two Althen prongs because we
    affirm the Court of Federal Claims’ primary holding that
    Ms. Olson did not carry her burden under Althen prong
    12                  OLSON v. SEC’Y OF HEALTH & HUMAN SERVS.
    CONCLUSION
    We have considered Ms. Olson’s remaining arguments
    and find them unpersuasive. Accordingly, the Judgment
    of the U.S. Court of Federal Claims is
    AFFIRMED
    one. See W.C. v. Sec’y of Health & Human Servs., 
    704 F.3d 1352
    , 1358 (Fed. Cir. 2013) (“[A] petitioner must
    establish all three prongs of the Althen test . . . .” (internal
    quotation marks and citation omitted)).