Court Opinion

ID: 4263271
Source: CourtListenerOpinion
Date Created: 2018-04-12 15:00:55.219048+00
Date Added: 2024-06-11T14:30:07.792145
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
               ______________________

            MYKELLE JIVON D'TIOLE,
               Petitioner-Appellant

                          v.

     SECRETARY OF HEALTH AND HUMAN
                 SERVICES,
             Respondent-Appellee
            ______________________

                     2017-1982
               ______________________

    Appeal from the United States Court of Federal
Claims in No. 1:15-vv-00085-EJD, Senior Judge Edward
J. Damich.
                ______________________

               Decided: April 12, 2018
               ______________________

    CURTIS RANDAL WEBB, Twin Falls, ID, argued for
petitioner-appellant.

    ROBERT PAUL COLEMAN, III, Vaccine/Torts Branch,
Civil Division, United States Department of Justice,
Washington, DC, argued for respondent-appellee. Also
represented by CHAD A. READLER, C. SALVATORE
2                                           D'TIOLE   v. HHS

D’ALESSIO, CATHARINE E. REEVES, GABRIELLE                M.
FIELDING, LARA A. ENGLUND.
                ______________________

       Before MOORE, LINN, and CHEN, Circuit Judges.
LINN, Circuit Judge.
     The parents and relatives of Mykelle Jivon D’Tiole
(collectively “D’Tiole”) appeal from the decision of the
Court of Federal Claims under the National Childhood
Vaccine Injury Act of 1986 (“Vaccine Act”), affirming the
determination by Special Master Brian H. Corcoran
denying compensation for narcolepsy with cataplexy
allegedly caused by administration of the FluMist vaccine.
D’Tiole v. Sec’y of Health & Human Servs., (“Special
Master Op.”) No. 15-85, 2016 WL 7664475, 2016 U.S.
claims LEXIS 2003 (Fed. Cl. Nov. 28, 2016), aff’d 132 Fed.
Cl. 421 (2017).
    Because the Special Master’s decision was not arbi-
trary, capricious, or an abuse of discretion, was legally
proper, see 42 U.S.C. § 300aa-12(e)(2)(B), and was based
on a plausible analysis of the record evidence, we affirm.
We write for the parties, and therefore omit the factual
and procedural background from this opinion.
                             A.
    In Althen v. Sec’y of Health & Human Services, 418
F.3d 1274 (Fed. Cir. 2005) and Capizzano v. Sec’y of
Health and Human Services, 440 F.3d 1317 (Fed. Cir.
2006), this court made clear that the Vaccine Act man-
dates proof of causation by a “preponderance of the evi-
dence,” 42 U.S.C. § 300aa-12(a)(1), “substantiated by
medical records or medical opinion,” Althen, 418 F.3d at
1279, but does not “require” medical documentation to
prove causation. Id. at 1280, 1281 (“To require Althen to
provide medical documentation would contravene the
D'TIOLE   v. HHS                                        3

plain language of the statute.”). See also Capizzano, 440
F.3d at 1325.
    D’Tiole argues that the Special Master violated Althen
and Capizzano by de facto requiring epidemiological
evidence because the Special Master gave undue weight
to Duffy 1 and did not give enough weight to the Han 2
studies.
    The Special Master considered Duffy as strong evi-
dence against Dr. Steinman’s theory that the evidence
linking Pandemrix (a vaccine using an inactivated form of
H1N1) to narcolepsy via molecular mimicry also estab-
lished a medical theory causally connecting FluMist (a
Live Attenuated Influenza Vacccine (“LAIV”)) to narcolep-
sy. In coming to that conclusion, the Special Master
explained the baseline deficiency in Dr. Steinman’s theo-
ry. The scientific literature indicated that the form of
manufacture of the inactive flu vaccine was likely in-
volved in the association of Pandemrix with narcolepsy.
Dr. Steinman’s theory fails to explain how this evidence
applies to the FluMist vaccine, which has a distinct
formulation and manufacturing process.
   The consideration of Duffy did not de facto improperly
require D’Tiole to provide epidemiological data to prove
causation. The Special Master explicitly wrote that he
was not requiring epidemiological evidence.       Special
Master Op. at 29 (“As a general matter, it is true that
Program petitioners need not offer epidemiological evi-
dence to establish their causation burden under Althen.

   1    Duffy J., et al., “Narcolepsy and Influenza
A(H1N1) pandemic 2009 in the United States,” Neurology,
83: 1823–1830 (2014) (“Duffy”)
    2   Han F, et al., “Narcolepsy onset is seasonal and
increased following the H1N1 pandemic in China,” Ann.
Neurol, 70(3): 410-417 (September 2011).
4                                              D'TIOLE   v. HHS

Indeed, because vaccine injuries are rare events, the fact
that a particular epidemiological study suggests a vaccine
is generally safe should not prevent a claimant from
prevailing.”); id. at 27 (“By petitioner’s admission, there is
no direct evidence of [causation] (although that fact does
not mean the claim could not succeed, given the ac-
ceptance in the [Vaccine] Program of the notion that
vaccine injuries are rare and otherwise need not be prov-
en with scientific certainty.”)). Indeed, the Special Master
noted possible probative evidence that would render
D’Tiole’s case stronger. Id. at 31 (“Petitioner’s theory
could well become more reliable once there is stronger
proof linking the LAIV form of the H1N1 flu vaccine, or
better and more consistent evidence linking the H1N1
wild virus alone, to narcolepsy. Studies measuring the
nucleoprotein antibody levels in individuals vaccinated
with FluMist would also be useful in supporting the
theory.”). The Special Master’s acceptance of Duffy’s
finding of a lack of a correlation between an LAIV vaccine
and narcolepsy as undermining Dr. Steinman’s theory, id.
at 29 (“[T]he Duffy epidemiologic study stood as very
strong evidence rebutting an association between an
LAIV containing the H1N1 strain and narcolepsy.”) did
not directly or implicitly require epidemiological proof of
causation. To the contrary, it simply reflects the Special
Master’s assessment of the record presented.
    Nothing in Althen or Capizzano requires the Special
Master to ignore probative epidemiological evidence that
undermines petitioner’s theory. See Andreu v. Health &
Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009)
(“Although Althen and Capizzano make clear that a
claimant need not produce medical literature or epidemio-
logical evidence to establish causation under the Vaccine
Act, where such evidence is submitted, the Special Master
can consider it in reaching an informed judgment as to
whether a particular vaccination likely caused a particu-
lar injury.” (emphasis added)); Grant v. Health & Human
D'TIOLE   v. HHS                                          5

Servs., 956 F.2d 1144, 1148-49 (Fed. Cir. 1992) (consider-
ing negative epidemiological studies). The Special Mas-
ter’s reliance on Duffy did not improperly raise the
standard in Althen beyond a preponderance of the evi-
dence.
    The Special Master also adequately explained that
there were “facial difficulties with giving [Han] too much
weight.” The Special Master noted specifically that, as
recognized in Dr. Steinman’s co-authored Ahmed II arti-
cle, the results in Han were not duplicated outside of
China and may have been the result of the high residen-
tial density in Hong Kong rather than the virus itself.
Special Master Op. at 28. “[W]e do not sit to reweigh the
evidence.” Lampe v. Sec’y of Health & Human Servs., 219
F.3d 1357, 1363 (Fed. Cir. 2000) (explaining that where
the Special Master’s “conclusion was based on evidence in
the record that was not wholly implausible, we are com-
pelled to uphold that finding as not being arbitrary or
capricious.”).
                            B.
    D’Tiole also argues that the Special Master abused his
discretion by deciding the case without an evidentiary
hearing. We do not agree.
     The decision to hold an evidentiary hearing is statuto-
rily committed to the discretion of the Special Master.
See 42 U.S.C. § 300aa-12(d)(3)(B)(v) (Special Master “may
conduct such hearings as may be reasonable and neces-
sary”). Nothing obliges the Special Master to hold such a
hearing. Id. Here, the Special Master afforded D’Tiole a
full and fair opportunity to present its case as required by
Vaccine Rule 3(b) by accepting and considering seven
expert reports, which addressed each of the arguments
presented by both parties. See Special Master Op. at 37.
D’Tiole does not point to any particular issues that the
expert reports did not cover. The Special Master ade-
quately explained that the primary issue—the presence or
6                                           D'TIOLE   v. HHS

absence of a reasonable theory of causation between the
LIAV FluMist vaccine and narcolepsy—would be deter-
mined wholly based on the strength of the scientific
evidence and the content of the seven expert reports, and
not on any credibility determinations for which an eviden-
tiary hearing could be helpful. D’Tiole has simply failed
to show any abuse of discretion in this determination.
    The Special Master’s determination was not arbitrary,
capricious or an abuse of discretion, was legally proper,
see 42 U.S.C. § 300aa-12(e)(2)(B), and was based on a
plausible analysis of the record evidence.
                      AFFIRMED
                         COSTS
    No costs.