Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-14-05077/USCOURTS-ca13-14-05077-0/pdf.json

Parties Involved:
Department of Health and Human Services
Appellee
Julia Simanski
Appellant
Todd Simanski
Appellant

Document Text:

NOTE: This disposition is nonprecedential.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 respondent-appellee. Also represented by STUART F.

DELERY, RUPA BHATTACHARYYA, VINCENT J. MATANOSKI,

CATHARINE E. REEVES.

______________________ 

Case: 14-5077 Document: 18-2 Page: 1 Filed: 02/26/2015
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 establishing 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 otherwise 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 pertussis, hepatitis B, Haemophilus influenzae type B, inactivated polio, and pneumococcal vaccines.

On January 30, 2001, O.A.S. went into respiratory arrest. After being rushed to Mercy Medical Center, she 

was intubated and placed on a ventilator. While at Mercy, 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 obCase: 14-5077 Document: 18-2 Page: 2 Filed: 02/26/2015
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 neuropathy, 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 demyelinating neuropathy,” weakness “consistent with a motor 

neuropathy or a sensorimotor axonal neuropathy,” and 

“not unlike axonal [Guillain–Barré Syndrome].” Respondent’s App. (R.A.) 113–14.

Guillain–Barré Syndrome (GBS) is a disease of unknown etiology that affects the peripheral nervous system. 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 traveling 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 resCase: 14-5077 Document: 18-2 Page: 3 Filed: 02/26/2015
4 SIMANSKI v. HHS

piratory failure. Test results during this stay at Mercy 

indicated that O.A.S.’s neurological condition was worsening. While at Mercy, O.A.S. was again placed on a ventilator. 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 otherwise 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 transferred to the University of Iowa Hospital and she stayed 

there for over three months. In June 2001, O.A.S.’s treating 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 diagnosis at admission was “flaccid axonal neuropathy.” She

was discharged in September 2001.

In September 2003, following her pediatrician’s recommendation, 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 question 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 

Case: 14-5077 Document: 18-2 Page: 4 Filed: 02/26/2015
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 diagnosis for [O.A.S.].” R.A. 185. Accordingly, Dr. Kuntz recommended 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 pediatrician 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 January 2001 vaccinations triggered adverse reactions. After 

several years of delays, the Simanskis fulfilled the reCase: 14-5077 Document: 18-2 Page: 5 Filed: 02/26/2015
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 appealed, 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 reports and further defined their positions. The government 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 polyneuropathy (CIDP), while recent medical records indicated that 

O.A.S. suffers from SMARD. Accordingly, the government 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 Simanskis 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, 

Case: 14-5077 Document: 18-2 Page: 6 Filed: 02/26/2015
SIMANSKI v. HHS 7

finding that it was not arbitrary, capricious, or unsupported 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. 

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8 SIMANSKI v. HHS

To establish causation in fact, a petitioner must provide 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 relationship 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 pathology, 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, including 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, diaphragmatic 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 twomonth 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 

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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 “reweigh 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 responses to IVIG treatments presented “the most compelling 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 “questionable” 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. 

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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, however, Dr. Kuntz changed her diagnosis to a “recently described” entity known as SMARD.1 R.A. 87–88. 

Importantly, many other treating physicians subsequently concluded that O.A.S. suffered from or presented symptoms 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 “favored” 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 Master 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. 

 

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SIMANSKI v. HHS 11

medical breakthroughs that might discredit the plausibility 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 arbitrarily 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.

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