Court Opinion

ID: 4353443
Source: CourtListenerOpinion
Date Created: 2018-12-21 17:01:04.900329+00
Date Added: 2024-06-11T14:45:00.035410
License: Public Domain

NOTE: This disposition is nonprecedential.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)).