Court Opinion

ID: 2782392
Source: CourtListenerOpinion
Date Created: 2015-02-26 17:01:03.514093+00
Date Added: 2024-06-11T11:01:59.341128
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

       TODD SIMANSKI, JULIA SIMANSKI,
  AS PARENTS AND NEXT FRIENDS OF O.A.S., A
                     MINOR,
              Petitioners-Appellants

                           v.

     DEPARTMENT OF HEALTH AND HUMAN
                 SERVICES,
             Respondent-Appellee
            ______________________

                      2014-5077
                ______________________

    Appeal from the United States Court of Federal
Claims in No. 1:03-VV-00103, Judge Marian Blank Horn.
                 ______________________

              Decided: February 26, 2015
               ______________________

   TODD AND JULIA SIMANSKI, Ankeny, Iowa, pro se.

    TRACI R. PATTON, Torts Branch, Civil Division, United
States Department of Justice, Washington, DC, for re-
spondent-appellee.   Also represented by STUART F.
DELERY, RUPA BHATTACHARYYA, VINCENT J. MATANOSKI,
CATHARINE E. REEVES.
                ______________________
2                                          SIMANSKI   v. HHS

    Before O’MALLEY, BRYSON, and HUGHES, Circuit Judges.
HUGHES, Circuit Judge.
    Todd Simanski and Julia Simanski appeal the United
States Court of Federal Claims’s affirmance of a Special
Master’s denial of compensation for their child, O.A.S.,
under the National Childhood Vaccine Injury Act. In
certain cases, identifying the injury that is a basis for a
claim under the Vaccine Act is a prerequisite to establish-
ing causation of an injury by a vaccine. Because the
Special Master did not act arbitrarily or capriciously by
finding that the evidence shows that O.A.S. suffers from a
disease for which the Simanskis did not put forth a theory
of causation, we affirm.
                             I
     O.A.S. was born on November 2, 2000. Although she
was diagnosed with intrauterine growth retardation and
had decreased muscle tone for a newborn, she was other-
wise healthy. At her two-month visit to her pediatrician,
she was diagnosed with infectious gastroenteritis and her
first set of scheduled vaccinations was deferred. On
January 26, 2001, O.A.S. returned to the pediatrician and
received doses of the diphtheria-tetanus-acellular pertus-
sis, hepatitis B, Haemophilus influenzae type B, inacti-
vated polio, and pneumococcal vaccines.
    On January 30, 2001, O.A.S. went into respiratory ar-
rest. After being rushed to Mercy Medical Center, she
was intubated and placed on a ventilator. While at Mer-
cy, she tested positive for respiratory syncytial virus
(RSV) and she was initially diagnosed with bronchiolitis.
During her stay at Mercy, doctors observed that O.A.S.
was suffering from diaphragmatic palsy (or weakness),
which is not a consequence of RSV. And twice the doctors
were unable to remove her from the ventilator because
she could not breathe independently. Doctors also ob-
SIMANSKI   v. HHS                                       3

served that O.A.S. had staring episodes, arching of the
back, and stiffening of the extremities.
    In February 2001, O.A.S. was transferred to the Mayo
Clinic for further diagnosis and treatment. While at the
Mayo Clinic, O.A.S. received intravenous immunoglobulin
(IVIG) treatments, after which her health improved to the
point where she could breathe on her own. Doctors at the
Mayo Clinic also performed many tests on O.A.S.’s blood,
nerves, and neuromuscular system. Based on the tests
and their observations, doctors concluded that O.A.S. may
have been suffering from sensorimotor peripheral neurop-
athy, i.e., impairment of the peripheral nerves, which are
the nerves outside of the brain and spine. Other records
from this time period suggested that O.A.S.’s doctors were
also considering more specific diagnoses. For example,
some medical records indicated “considering Guillain
Barre [sic] syndrome,” “probable post-infectious demye-
linating neuropathy,” weakness “consistent with a motor
neuropathy or a sensorimotor axonal neuropathy,” and
“not unlike axonal [Guillain–Barré Syndrome].”         Re-
spondent’s App. (R.A.) 113–14.
    Guillain–Barré Syndrome (GBS) is a disease of un-
known etiology that affects the peripheral nervous sys-
tem. Doctors generally believe that GBS may begin
through an autoimmune mechanism. The most common
form, which the Simanskis allege O.A.S. may suffer from,
is the demyelinating type. Demyelinating-type GBS
results in an impairment of sensorimotor signals travel-
ing through the body’s nerves and is characterized by a
degradation of myelin, a substance that covers peripheral
nerves.
    In March 2001, O.A.S. was transferred from the Mayo
Clinic back to Mercy. Mercy records dated March 21,
2001 state that it was “probable” O.A.S. had GBS. R.A.
177. Although she was discharged from Mercy in late
March, O.A.S. was readmitted in April 2001 due to res-
4                                          SIMANSKI   v. HHS

piratory failure. Test results during this stay at Mercy
indicated that O.A.S.’s neurological condition was worsen-
ing. While at Mercy, O.A.S. was again placed on a venti-
lator. Since then, O.A.S. has required the permanent
assistance of a ventilator.
    In late April 2001, O.A.S. was transferred to Johns
Hopkins University Hospital. Mercy’s discharge papers
state that the “lack of a definitive diagnosis has been a
problem in addressing the extent of supporting the child.”
R.A. 86. Johns Hopkins records from April 2001 similarly
indicate inconclusive diagnoses. One progress note states
“post-infectious demyelinating neuropathy vs. spinal
muscular atrophy vs. degenerative vs. other [not other-
wise specified].” R.A. 86. Nonetheless, doctors at Johns
Hopkins concluded that O.A.S.’s condition was “consistent
with either a motor neuropathy or a sensorimotor axonal
neuropathy.” R.A. 86.
    After her stay at Johns Hopkins, O.A.S. was trans-
ferred to the University of Iowa Hospital and she stayed
there for over three months. In June 2001, O.A.S.’s treat-
ing physician recorded an improving clinical picture and
after consulting a doctor from Atlanta, Georgia, noted
that the Atlanta doctor “favors a diagnosis of an acute
axonal neuropathy.” R.A. 183.
    O.A.S. returned to Mercy in August 2001. Her diag-
nosis at admission was “flaccid axonal neuropathy.” She
was discharged in September 2001.
    In September 2003, following her pediatrician’s rec-
ommendation, O.A.S. returned to the Mayo Clinic for
further evaluation. During this visit, Dr. Nancy Kuntz, a
pediatric neurologist at the Mayo Clinic, began to ques-
tion whether O.A.S. had spinal muscular atrophy with
respiratory distress (SMARD). See R.A. 185 (quoting
doctor’s note stating “[Question] SMARD”). SMARD is a
genetic disease that can begin with the sudden onset of
respiratory distress within the first thirteen months of
SIMANSKI   v. HHS                                         5

life. This disease often involves diaphragmatic palsy and,
like GBS, it involves dysfunction of the nervous system.
    In one report, Dr. Kuntz wrote that her observations
“suggest[ ] progressive motor and sensory neuronopathy
or axonopathy. I believe that this is compatible with a
recently described entity called . . . SMARD. I believe
that it would be very critical for us to confirm the diagno-
sis for [O.A.S.].” R.A. 185. Accordingly, Dr. Kuntz rec-
ommended that O.A.S. and her parents send genetic
material to doctors who were investigating SMARD.
Ultimately, the Simanskis did not send materials for
genetic testing. Nonetheless, Dr. Kuntz diagnosed O.A.S.
with SMARD.
     The record indicates that from this point forward in
O.A.S.’s life, doctors often, but not always, stated that
O.A.S. had SMARD. In November 2003, O.A.S.’s pedia-
trician wrote a letter to an insurance company stating
that O.A.S. had SMARD. In February 2004, a pediatric
intensivist at Mercy summarized O.A.S.’s condition as
“[k]nown neuromuscular disorder-SMA-RD type.” R.A.
186.    In October 2004, O.A.S.’s pediatrician noted
Dr. Kuntz’s diagnosis, but with the caveat that it had not
yet been confirmed. And in 2004 and 2005, other treating
doctors noted a neuromuscular condition of unknown
origin. Additionally, O.A.S.’s pediatric neurologist stated
in January 2007 that O.A.S. had “a clinical diagnosis of
sensorimotor axonal neuropathy that also can be called
[SMARD].” R.A. 186. Similarly, in 2008, 2011, and 2012,
other treating physicians assessed O.A.S. as having either
spinal muscular atrophy or SMARD.
                             II
    On January 17, 2003, the Simanskis filed a petition
under the National Childhood Vaccine Injury Act of 1986,
42 U.S.C. §§ 300aa–1 to –34, alleging that O.A.S.’s Janu-
ary 2001 vaccinations triggered adverse reactions. After
several years of delays, the Simanskis fulfilled the re-
6                                          SIMANSKI   v. HHS

quirements for filing a petition. They also filed medical
records, affidavits, and expert reports from Dr. Yehuda
Shoenfeld, an immunologist, and Dr. Paul Maertens, a
pediatric neurologist, in support of their petition. In
2010, a Special Master declined to address the merits of
the Simanskis’ case, citing the Simanskis’ failure to
comply with a show-cause order. The Simanskis ap-
pealed, and we reversed the dismissal in 2012, ordering
the Special Master to address the merits of the Simanskis’
petition. See Simanski v. Sec’y of Health & Human
Servs., 671 F.3d 1368 (Fed. Cir. 2012).
    On remand, the parties submitted several expert re-
ports and further defined their positions. The govern-
ment submitted expert reports from Dr. Christine
McCusker, a pediatric immunologist, and Dr. Richard
Finkel, a pediatric neurologist. The government and its
experts asserted that the Simanskis’ experts incorrectly
assumed O.A.S. suffered from either GBS or a related
disease, chronic inflammatory demyelinating polyneurop-
athy (CIDP), while recent medical records indicated that
O.A.S. suffers from SMARD. Accordingly, the govern-
ment argued that the vaccinations could not have caused
SMARD, which is caused by a genetic mutation. The
Simanskis and their experts took the position that O.A.S.
suffers from GBS or CIDP, not SMARD, and that the
vaccinations caused O.A.S.’s GBS or CIDP. The Siman-
skis did not present any alternative claim based on a
diagnosis of SMARD.
    After evidentiary hearings and additional briefing,
the assigned Special Master issued a decision denying
compensation. In a detailed opinion that reviewed the
parties’ filings and the evidence, the Special Master found
that O.A.S. suffers from SMARD, not GBS or CIDP, and
that the Simanskis did not put forth any evidence to
establish that the vaccinations caused or aggravated
SMARD. On petition for review, the United States Court
of Federal Claims affirmed the Special Master’s decision,
SIMANSKI   v. HHS                                           7

finding that it was not arbitrary, capricious, or unsup-
ported by substantial evidence. Simanski v. Sec’y of
Health & Human Servs., 115 Fed. Cl. 407, 457 (2014).
    The Simanskis appeal. We have jurisdiction pursuant
to 42 U.S.C. § 300aa–12(f).
                             III
    In Vaccine Act cases, we review de novo a decision by
the Court of Federal Claims, applying the same standard
of review as that court applies in reviewing a decision of a
Special Master. See Andreu v. Sec’y of Dep’t of Health &
Human Servs., 569 F.3d 1367, 1373 (Fed. Cir. 2009).
Accordingly, we will set aside any findings of fact or
conclusions of law by a Special Master that are arbitrary,
capricious, an abuse of discretion, or otherwise not in
accordance with law. 42 U.S.C. § 300aa–12(e)(2)(B). Our
review is uniquely deferential, and “[i]f 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.’” Hazlehurst v. Sec’y of Health & Human
Servs., 604 F.3d 1343, 1349 (Fed. Cir. 2010) (quoting
Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518,
1528 (Fed. Cir. 1991)).
     A petitioner seeking compensation under the Vaccine
Act must prove by a preponderance of the evidence that a
covered vaccine caused the claimed injury. 42 U.S.C.
§§ 300aa–11(c)(1), –13(a)(1). If the claimed injury is not
listed in the Vaccine Injury Table, the petitioner may seek
compensation by proving causation in fact. 42 U.S.C.
§ 300aa–11(c)(1)(C)(ii); Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010).
Here, neither GBS nor CIDP are listed in the Vaccine
Injury Table. See 42 U.S.C. § 300aa–14; Figueroa v. Sec’y
of Health & Human Servs., 715 F.3d 1314, 1315 (Fed. Cir.
2013). It is undisputed that the Simanskis must prove
causation in fact. Simanski, 671 F.3d at 1371.
8                                           SIMANSKI   v. HHS

    To establish causation in fact, a petitioner must pro-
vide a medical theory causally connecting the vaccination
and the injury, a logical sequence of cause and effect
showing that the vaccination was the reason for the
injury, and a showing of a proximate temporal relation-
ship between vaccination and injury. Althen v. Sec’y of
Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir.
2005). In this case—where “the injury itself is in dispute,
the proposed injuries differ significantly in their patholo-
gy, and the question of causation turns on which injury
[O.A.S.] suffered”—identifying the injury is a prerequisite
to the Althen analysis. Broekelschen v. Sec’y of Health &
Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010); see
also Lombardi v. Sec’y of Health & Human Servs., 656
F.3d 1343, 1352–53 (Fed. Cir. 2011).
     The Special Master’s decision thoroughly reviewed all
of the relevant evidence and the parties’ positions, includ-
ing the expert witnesses’ testimonies. After focusing
primarily on Dr. Maertens’s and Dr. Finkel’s opinions on
whether O.A.S. suffered from GBS, CIDP, or SMARD, the
Special Master found that the record evidence supports a
finding that O.A.S. suffers from SMARD. R.A. 148. This
finding was supported by a reasoned explanation of at
least twelve categories of evidence relating to the etiology
and nature of O.A.S.’s condition.
    The categories of evidence included, among other
things, the date of onset, respiratory failure, diaphrag-
matic palsy, ventilator assistance, responses to IVIG
treatments, and the diagnoses from O.A.S.’s treating
physicians since 2001. The Special Master found that
Dr. Maertens conceded that the onset of GBS in a two-
month old infant is “extremely rare,” while the onset of
respiratory failure at two months could occur with
SMARD. R.A. 195. The Special Master also considered
the consensus between the portions of Dr. Maertens’s and
Dr. Finkel’s testimonies acknowledging that respiratory
failure is consistent with SMARD. Further, the Special
SIMANSKI   v. HHS                                        9

Master’s decision quotes Dr. Maertens’s recognition that
diaphragmatic palsy, although it could have other causes,
was “a fundamental aspect of considering that a child has
SMARD.” R.A. 166. Likewise, Dr. Maertens testified that
O.A.S.’s progression to permanent ventilator support
“would probably go more towards SMARD.” R.A. 197.
    Given the foregoing evidence, we cannot say that the
Special Master’s finding that O.A.S. suffered from
SMARD was “wholly implausible” or otherwise arbitrary
and capricious. Lampe v. Sec’y of Health & Human
Servs., 219 F.3d 1357, 1363 (Fed. Cir. 2000). On appeal,
the Simanskis focus on the Special Master’s evaluation of
the various categories of evidence. But we do not “re-
weigh the factual evidence, assess whether the special
master correctly evaluated the evidence, 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 & Human
Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011).
    The Simanskis also argue that O.A.S.’s positive re-
sponses to IVIG treatments presented “the most compel-
ling case against a diagnosis of SMARD and in favor of
GBS.” Appellant’s Informal Br. 14. The Special Master
found that one of the criteria for establishing a diagnosis
of GBS includes a positive response to IVIG treatment.
But the Special Master considered all of the evidence
relating to IVIG treatments and found this category of
evidence to be “a closer call” because O.A.S. improved only
slightly, if at all, following subsequent treatments and
because O.A.S.’s treating pediatrician observed a “ques-
tionable” degree of response to the treatments. R.A. 209.
Accordingly, the Special Master found that this evidence
did not favor a finding of GBS or CIDP. On our review of
the Special Master’s decision, we may not “second guess”
such “fact-intensive conclusions.” Hodges v. Sec’y of Dep’t
of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir.
1993); see also Porter, 663 F.3d at 1249.
10                                         SIMANSKI   v. HHS

    The Special Master’s decision also accounts for the
complicated circumstance of the medical community’s
understanding of what could possibly be affecting O.A.S.
and the evolution of that understanding over time. The
doctors at the Mayo Clinic initially stated that they were
considering GBS as a possible diagnosis. In 2003, howev-
er, Dr. Kuntz changed her diagnosis to a “recently de-
scribed” entity known as SMARD. 1             R.A. 87–88.
Importantly, many other treating physicians subsequent-
ly concluded that O.A.S. suffered from or presented symp-
toms of the recently described SMARD.
    The Special Master reviewed the foregoing evidence
and concluded that O.A.S.’s treating physicians have
“consistently referenced SMARD as the proper diagnosis
since 2003.” R.A. 212. This finding was not arbitrary or
capricious. And to the extent that the finding relied on
medical records from treating physicians, we note that we
have held such records can be “quite probative” or “fa-
vored” when considering issues relating to claims under
the Vaccine Act. Capizzano v. Sec’y of Health & Human
Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006); see also
Cucuras v. Sec’y of Dep’t of Health & Human Servs., 993
F.2d 1525, 1528 (Fed. Cir. 1993) (“Medical records, in
general, warrant consideration as trustworthy evidence.”).
We should not “require special masters to ignore the
impact of ever-changing technological advances and

     1  The Court of Federal Claims and the Special Mas-
ter found that Dr. Kuntz and other treating physicians
may have learned of SMARD from a series of articles
published in 2001 and 2003. The Special Master further
found that there was no dispute that most pediatric
neurologists did not know about SMARD until 2003. Dr.
Maertens, for example, first learned of SMARD no sooner
than 2005.
SIMANSKI   v. HHS                                        11

medical breakthroughs that might discredit the plausibil-
ity of a formerly accepted theory.” Rickett v. Sec’y of
Health & Human Servs., 468 F. App’x 952, 959 (Fed. Cir.
2011).
     Since the Simanskis did not establish the predicate of
O.A.S. having GBS or CIDP, the Special Master found
that it was not necessary to evaluate Dr. Shoenfeld’s
theory that the vaccinations caused GBS or CIDP. A
review of the record indicates that Dr. Shoenfeld indeed
assumed that O.A.S. had GBS or CIDP, not SMARD. See,
e.g., Petitioner’s App. (P.A.) 55, ll. 10–12 (“I didn’t even
raise the possibility because nothing support[s] the
SMARD, and all my testimony was concentrated on
[GBS].”). Moreover, the Special Master found that the
Simanskis did not present any alternative claim based on
SMARD or any evidence on whether O.A.S.’s vaccinations
played a causal or aggravating role under the assumption
that she has SMARD. R.A. 217–18. The Simanskis do
not challenge these findings. See R.A. 84 (“there was no
need to explore in detail . . . whether the vaccines could
have adversely affected [O.A.S.]’s SMARD via the Althen
test”). Accordingly, the Special Master did not act arbi-
trarily or capriciously in declining to review
Dr. Shoenfeld’s opinions. See Broekelschen, 618 F.3d at
1345–46.
                            IV
    We sympathize with the Simanskis, but we conclude
that the Special Master’s decision was not “arbitrary,
capricious, an abuse of discretion, or otherwise not in
accordance with law.” 42 U.S.C. § 300aa–12(e)(2)(B). We
have considered the remaining arguments and do not find
them persuasive. Accordingly, we affirm the judgment of
the Court of Federal Claims.
                       AFFIRMED

   No costs.