United States Court of Appeals
for the Federal Circuit
__________________________
TODD SIMANSKI AND JULIA SIMANSKI,
AS PARENTS AND NEXT FRIENDS OF OLIVIA ANN
SIMANSKI,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________
2011-5050
__________________________
Appeal from the United States Court of Federal
Claims in Case No. 03-VV-103, Judge Christine O.C.
Miller.
___________________________
Decided: March 6, 2012
___________________________
Sylvia Chin-Caplan, Conway, Homer & Chin-Caplan,
P.C. of Boston, Massachusetts, argued for petitioners-
appellants. On the brief was RONALD C. HOMER
TRACI R. PATTON, Trial Attorney, Torts Branch, Civil
Division, United States Department of Justice, of Wash-
ington, DC, argued for respondent-appellee. With her on
SIMANSKI v. HHS 2
the brief were TONY WEST, Assistant Attorney General,
MARK W. ROGERS, Acting Director, VINCENT J.
MATANOSKI, Acting Deputy Director, and CATHARINE E.
REEVES, Assistant Director.
__________________________
Before BRYSON, MOORE, and REYNA, Circuit Judges.
BRYSON, Circuit Judge.
This case requires us to examine the procedures em-
ployed by a special master in adjudicating a petition for
compensation stemming from a vaccine-related injury.
The procedural history of this case is quite complex, and
to conduct a fair assessment of the issues raised on appeal
requires that we review it in some detail.
I
A
Olivia Simanski was born on November 2, 2000.
Aside from having a low birth weight, she appeared to be
healthy. She was scheduled to receive her first set of
vaccines at a pediatric visit two months later, but because
she was suffering from some gastrointestinal problems at
that time, her pediatrician decided to postpone the inocu-
lations. Two days later, on January 26, 2001, Olivia
returned to the pediatrician’s office and received the
following five vaccines: diphtheria, acellular pertussis,
and tetanus; haemophilus influenzae type B; inactivated
polio vaccine; pneumococcal conjugate; and a hepatitis B
vaccine.
Three days after receiving the shots, Olivia experi-
enced a change in her overall well-being. Her mother
described Olivia as being lethargic, mildly irritated,
3 SIMANSKI v. HHS
lacking in appetite, and having labored breathing. The
next day, Olivia suffered acute respiratory failure and
was rushed to a nearby hospital. There she was intu-
bated and placed on a ventilator. Her treating physicians
thought that she might have been infected with respira-
tory syncytial virus (“RSV”). They took cultures for the
presence of that virus, which came back positive.
Olivia’s condition required extensive hospitalization
and treatment. She was initially treated at the admitting
hospital but was subsequently transferred to other insti-
tutions for diagnosis and treatment. Throughout the
course of her treatment, several of Olivia’s treating physi-
cians concluded that she was suffering from either Guil-
lain-Barré Syndrome (“GBS”), an acute neurologic
disorder of the peripheral nervous system, or a GBS-like
syndrome. Although Olivia’s condition subsequently
stabilized, she still requires the use of a ventilator and a
wheelchair, and she faces many physical and developmen-
tal challenges.
B
Olivia’s parents filed a petition with the National
Vaccine Injury Compensation Program on January 17,
2003. Congress created that program in 1986 when it
enacted the National Childhood Vaccine Injury Act (“the
Vaccine Act”), 42 U.S.C. §§ 300aa-1 to 300aa-34, to pro-
vide compensation for vaccine-related injuries and deaths.
The Vaccine Act identifies two categories of compensable
vaccine injuries: “Table injuries” and “off-Table injuries.”
“Table injuries” are those covered by the Vaccine In-
jury Table. The Table consists of a list of conditions that
have been determined to be significantly associated with
particular vaccines when the symptoms or manifestations
SIMANSKI v. HHS 4
of those conditions arise within a specified period after
the administration of the vaccine. 42 U.S.C. § 300aa-14;
42 C.F.R. § 100.3. For an injury covered by the Vaccine
Injury Table, the statute creates a presumption that the
vaccine caused the injury in question. Terran v. Sec’y of
Health & Human Servs., 195 F.3d 1302, 1307 (Fed. Cir.
1999).
“Off-Table injuries” are injuries that are not covered
by the Vaccine Injury Table. Petitioners with off-Table
injuries cannot rely on the statutory presumption of
causation but instead must demonstrate actual causation
by a preponderance of competent evidence. See Moberly v.
Sec’y of Health & Human Servs., 592 F.3d 1315, 1321-22
(Fed. Cir. 2010). Because it is undisputed that the injury
in this case is not covered by the Table, the parties have
treated this as an off-Table case. In order to establish
entitlement to compensation, the Simanskis are therefore
required to show, by a preponderance of the evidence,
that one or more of the vaccines that were administered
to Olivia caused or significantly aggravated her condition.
42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), 300aa-13(a)(1)(A).
Congress vested jurisdiction over Vaccine Act cases in
the Court of Federal Claims and authorized the creation
of the Office of Special Masters to adjudicate the petitions
for compensation. See 42 U.S.C. § 300aa-12. Congress
envisioned that the special masters would become special-
ists in vaccine-related injuries and would use “their
accumulated expertise in the field [to] judg[e] the merits
of the individual claims.” Lampe v. Sec’y of Health &
Human Servs., 219 F.3d 1357, 1362 (Fed. Cir. 2000),
quoting Hodges v. Sec’y of the Dep’t of Health & Human
Servs., 9 F.3d 958, 961 (Fed. Cir. 1993).
5 SIMANSKI v. HHS
The Vaccine Act directs the Court of Federal Claims,
with input from the special masters, to promulgate rules
of procedure for Vaccine Act cases. 42 U.S.C. § 300aa-
12(d)(2). The statute directs that the rules shall, inter
alia, “provide for a less-adversarial, expeditious, and
informal proceeding for the resolution of petitions, . . .
include flexible and informal standards of admissibility of
evidence, [and] include the opportunity for summary
judgment.” Id.
In accordance with that mandate, the Court of Fed-
eral Claims has promulgated a set of rules known as the
Vaccine Rules. See Vaccine Rules of the U.S. Court of
Federal Claims, Rules of Ct. of Fed. Claims app. B. Those
rules are designed to ensure that claims for compensation
under the Vaccine Act are resolved in a manner that is
both speedy and fair. See 42 U.S.C. § 300aa-12(d); see
also Vaccine R. 3(b)(2).
The statute and the Vaccine Rules give the special
masters broad authority in conducting proceedings under
the Act, including full control over discovery and the
power to require the production of evidence and informa-
tion. 42 U.S.C. § 300aa-12(d)(3); see also Vaccine R. 3(a),
7(a), 8(c). The Vaccine Rules also provide that a special
master may “dismiss a petition . . . for failure of the
petitioner to . . . comply with these rules or any order of
the special master.” Vaccine R. 21(b)(1).
While allowing for flexibility, the Vaccine Rules con-
tain certain procedural requirements to guarantee fair-
ness in the adjudicatory process. For instance, parties
retain the ability to ask for formal discovery if they be-
lieve, in a particular case, that informal production is
insufficient. See Vaccine R. 7(b). Moreover, the Vaccine
Rules provide that that the special masters can decide
SIMANSKI v. HHS 6
cases on written submissions, including, in appropriate
cases, by summary judgment. See Vaccine R. 8(d); see
also 42 U.S.C. § 300aa-12(d)(2)(C) (requiring that the
Vaccine Rules include the opportunity for summary
judgment).
C
Pursuant to the statutory scheme, when the Si-
manskis filed their petition for compensation due to
Olivia’s injuries, the petition was assigned to a special
master. After several periods of delay, the Simanskis
ultimately perfected their petition by submitting medical
records, an affidavit from Olivia’s mother, and reports
from two medical experts in support of their claim.
The Simanskis’ first expert report was one prepared
by Dr. Paul Maertens, who stated that in his opinion
Olivia’s respiratory failure was due to RSV. Dr. Maertens
noted, however, that the vaccines she received “could have
played a role” in her condition. The report proposed a
theory by which the vaccines could have had such an
effect, but stated that the determination of whether the
immunizations were a factor in the onset of symptoms
was one “best made by an immunologist.”
The special master concluded that Dr. Maertens’ re-
port alone was insufficient to establish a prima facie
claim of causation. The Simanskis then explained that
they were consulting with an immunologist to obtain an
additional expert report. In 2009, an immunologist, Dr.
Yehuda Shoenfeld, examined materials the Simanskis
provided to him and submitted an expert report and
supporting documentation, including a large number of
references to medical literature.
7 SIMANSKI v. HHS
In his report, Dr. Shoenfeld cited articles supporting
the theory that several of the vaccines Olivia received
could cause GBS or its chronic variant, chronic inflamma-
tory demyelinating polyneurophathy (“CIPD”). He pro-
posed several potential mechanisms by which the
vaccines could have caused Olivia’s condition. He ex-
plained that autoimmune diseases such as GBS and CIPD
can be triggered in susceptible persons by environmental
agents such as infections and vaccinations, and that the
contents of the vaccines such as diluents, adjuvants,
preservatives, and stabilizers, could lead to the develop-
ment of autoimmunity. He cited literature for the propo-
sition that “molecular mimicry” is the most likely
mechanism by which vaccines cause autoimmune condi-
tions. At the end of his report, Dr. Shoenfeld stated,
“Therefore with great confidence and certain[t]y I can say
that the vaccines with all their immunological aspects
were the cause of the GBS/CIPD leading to phrenic nerve
paralysis and failure to extubate Olivia Simanski from
artificial respiration.”
D
After the Simanskis submitted Dr. Shoenfeld’s report,
the special master held a status conference at which he
discussed the report with the parties. See Simanski v.
Sec’y of Health & Human Servs., No. 03-vv-103, Dkt. No.
85 (Fed. Cl. Spec. Mstr. Apr. 13, 2009) (April 13, 2009,
Order). The Simanskis asserted that the Shoenfeld report
sufficed to meet their burden under Althen v. Secretary of
Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005),
to establish causation. The respondent disagreed and
contended that the report was deficient in several re-
spects. The respondent claimed that rather than obtain-
ing and submitting its own expert report to refute Dr.
SIMANSKI v. HHS 8
Shoenfeld’s conclusions, it intended to file a motion for
summary judgment. April 13, 2009, Order at 2.
The special master concluded that Dr. Shoenfeld’s re-
port raised questions about Dr. Shoenfeld’s position
regarding the issue of causation. In particular, the spe-
cial master identified the following questions as left
unresolved by the report: (1) which vaccine Dr. Shoenfeld
believes was responsible for causing Olivia’s adverse
reaction; (2) if Dr. Shoenfeld believes that the acellular
pertussis vaccine caused Olivia’s adverse reaction,
whether the acellular nature of the vaccine would affect
his opinion in light of recent changes in the make-up of
the pertussis vaccine; (3) whether Dr. Shoenfeld has a
theory that would explain, to the level of more probable
than not, how one or more of the vaccines caused Olivia’s
adverse reaction; (4) how Dr. Shoenfeld would account for
the treating doctors’ suggestions that Olivia’s problems
were caused by an RSV infection; and (5) whether Dr.
Shoenfeld had presented “a logical sequence of cause and
effect showing that the vaccination was the reason for the
injury,” Althen, 418 F.3d at 1278, particularly with re-
spect to the timing of the onset of symptoms. Dr.
Shoenfeld’s report indicated that GBS resulting from a
vaccination typically manifests itself no sooner than five
days after the vaccination, whereas Olivia’s respiratory
failure occurred only four days after she received the
vaccines.
Although the Simanskis stated that they were com-
fortable resting on Dr. Shoenfeld’s report and did not wish
to obtain a supplemental report, the special master stated
that he would afford the Simanskis an opportunity to
review the record and supplement it if they so desired.
The special master added that if the Simanskis “believe
that the existing record supports a finding that they have
9 SIMANSKI v. HHS
met their burden, then respondent has indicated that he
[sic] will file a motion for summary judgment and seek a
ruling before obtaining an expert report.” April 13, 2009,
Order at 2.
E
In response to the special master’s order, the Si-
manskis submitted a supplemental report in the form of a
two-page letter from Dr. Shoenfeld. The letter addressed
the timing issue raised by the special master but did not
otherwise address the special master’s questions. As to
the issue of timing, Dr. Shoenfeld wrote that the early
onset of Olivia’s symptoms could be attributable to her
very young age and immature immune system, which can
produce “great variability in the onset of timing between
one individual and another,” or to a condition known as
“congenital autoimmunity.” That condition, he explained,
results from prior sensitization of an infant’s mother to a
vaccine or to bacteria that can result in “passive transfers
of antibodies,” which in turn can “enhance and accelerate
the eventual reaction” or result in “enhanced autoimmu-
nity.”
The special master found Dr. Shoenfeld’s supplemen-
tal report to be lacking, in that it failed to address four of
the five questions he had raised. Stating that the sup-
plemental report “requires additional clarification and/or
explanation,” the special master issued an order giving
the Simanskis an opportunity to file a second supplemen-
tal report. The special master added several other points
that he said needed clarification in light of Dr. Shoenfeld’s
supplemental report.
With respect to the timing issue, the special master
asked that Dr. Shoenfeld explain which of Olivia’s initial
SIMANSKI v. HHS 10
symptoms were indications of an autoimmune reaction
and whether those symptoms were manifestations of GBS
or some other autoimmune disease. The special master
also asked Dr. Shoenfeld to explain how the immune
system of a three-month-old child differs from that of an
adult, and whether the literature discussing the develop-
ment of neurologic conditions in adults who have received
different types of vaccines is relevant to the way Olivia
reacted. In light of Dr. Shoenfeld’s reference to “congeni-
tal autoimmunity,” the special master asked whether Dr.
Shoenfeld believed it was reasonably probable that con-
genital autoimmunity contributed to Olivia’s development
of GBS and whether Dr. Shoenfeld believed it was rea-
sonably probable that Olivia’s mother had a prior sensiti-
zation to bacteria that contributed to Olivia’s condition.
In requesting that additional information, the special
master again noted that “[m]ore information from Dr.
Shoenfeld is especially advantageous in this case” because
the respondent had stated that it intended to file a motion
for summary judgment arguing that the Simanskis had
not met their burden of proof under Althen. In addition,
the special master stated that “a written disclosure of all
of Dr. Shoenfeld’s opinions will allow respondent and [the
special master] to prepare for the hearing” and “eliminate
any surprise testimony and thereby increase the likeli-
hood that the hearing can be completed in one session.”
Simanski v. Sec’y of Health & Human Servs., No. 03-vv-
103, Dkt. No. 89 (Fed. Cl. Spec. Mstr. June 26, 2009)
(June 26, 2009, Order).
F
The Simanskis responded to the June 26, 2009, Order
by stating that they would not produce a second supple-
mental report from Dr. Shoenfeld. They took the position
11 SIMANSKI v. HHS
that it was unreasonable for the special master to require
such detail at the pre-hearing stage of the proceeding
when, in their view, the evidence they had submitted at
that point had established a prima facie case that Olivia’s
vaccines caused her GBS. They argued that the respon-
dent should be required to address the reasons, if any,
why compensation should be denied. They added that the
questions propounded by the special master in his two
previous orders “not only serve as a disincentive for the
respondent to resolve the case, but inappropriately pro-
vide the respondent, and the respondent’s expert, with a
road map as to how to attack the opinions of Dr.
Shoenfeld.” In any event, they noted, the respondent’s
expert might agree with much of what Dr. Shoenfeld had
stated and might answer some of the special master’s
questions.
In the alternative, the Simanskis argued, the special
master could invite the respondent to move for summary
judgment. In that event, the Simanskis said, they would
respond and the special master could then issue a ruling
based on the state of the record at that time.
G
Several months later, the special master issued an or-
der to show cause why the Simanskis’ petition should not
be dismissed. See Simanski v. Sec’y of Health & Human
Servs., No. 03-vv-103, Dkt. No. 94 (Fed. Cl. Spec. Mstr.
Nov. 20, 2009) (Order to Show Cause). That order con-
sisted of a lengthy opinion that summarized the facts of
the case and addressed the special master’s authority to
direct the submission of a supplemental report. Besides
discussing the consequences of failing to comply with such
an order, the special master addressed whether dismissal
SIMANSKI v. HHS 12
of the petition would be a permissible sanction in these
circumstances.
Apart from the discussion of the propriety of ordering
the production of additional evidence and dismissing the
petition as a sanction for failure to comply with such an
order, the special master devoted a considerable portion of
the Order to Show Cause to addressing the merits of the
case. After analyzing the evidence submitted by the
Simanskis, the special master concluded that the Si-
manskis had not established causation and that, without
more evidence, dismissal was appropriate.
To begin with, the special master noted that Dr.
Shoenfeld had not identified the vaccine that caused
Olivia’s GBS. Dr. Shoenfeld reported that the principal
vaccine associated with GBS is the influenza vaccine,
which Olivia did not receive. With respect to other vac-
cines, including ones Olivia did receive, the special master
noted that Dr. Shoenfeld simply stated that those vac-
cines “are involved with” GBS. As to the pertussis vac-
cine, which Dr. Shoenfeld discussed in his report, the
special master identified “several gaps” in Dr. Shoenfeld’s
discussion. First, Olivia did not receive the whole cell
version of the pertussis vaccine, and many of the articles
cited by Dr. Shoenfeld in support of his opinion were
directed to the whole cell version of that vaccine. The
special master stated that “Dr. Shoenfeld may believe
that the acellular pertussis vaccine [that Olivia received]
can cause the same problems as the whole cell pertussis
vaccine,” but that “[i]f Dr. Shoenfeld holds this belief,
then he should clearly state his opinion and provide the
basis for his opinion.” Second, the special master noted
that Dr. Shoenfeld had stated that the pertussis vaccine
“can aggravate other infections” but added that Dr.
Shoenfeld did not state that he believed, to a level of
13 SIMANSKI v. HHS
medical probability, that the acellular pertussis vaccine
aggravated Olivia’s RSV infection. If Dr. Shoenfeld did
hold such a belief, the special master added, he “should
propose that theory explicitly.”
As to Dr. Shoenfeld’s discussion of the mechanism by
which vaccines can induce autoimmunity, the special
master found “multiple problems” with the report. First,
although the report discussed autoimmunity generally, it
did not “connect autoimmunity to Olivia.” Second, Dr.
Shoenfeld expressed his views in terms of what conditions
“may” trigger autoimmunity, which the special master
viewed as not constituting “probative evidence that it was
more likely than not that a vaccine did cause a problem.”
The special master concluded that Dr. Shoenfeld needed
to “articulate his opinion that ‘it is more probable than
not’ that something happened (or did not happen),” and
that his statement that a vaccine “may induce autoimmu-
nity” was not sufficient to “discharge the Simanskis’
obligation to present a preponderance of evidence.” Third,
the special master complained that Dr. Shoenfeld had
failed to identify which vaccine may have triggered an
autoimmune response.
With respect to Dr. Shoenfeld’s discussion of the the-
ory of “molecular mimicry” as an explanation relating
vaccine exposure to an autoimmune response, the special
master first noted that Dr. Shoenfeld did not state that he
believed it was more likely than not that molecular mim-
icry resulting from vaccine exposure explained Olivia’s
GBS. Moreover, Dr. Shoenfeld did not “provide a basis for
finding that molecular mimicry is a reliable theory in
Olivia’s case.” According to the special master, in the
absence of an explanation of how molecular mimicry could
have been responsible for Olivia’s condition, Dr.
Shoenfeld’s “simple assertion of molecular mimicry” did
SIMANSKI v. HHS 14
not constitute a reliable medical theory causally connect-
ing Olivia’s vaccination and her injury, as required by the
Althen test. 1
Turning to the issue of the temporal relationship be-
tween Olivia’s vaccination and the onset of her injury, the
special master noted that although Dr. Shoenfeld ac-
knowledged that the appropriate interval between vacci-
nation and the onset of a condition such as GBS is 5 to 21
days, and that Olivia’s respiratory failure occurred four
days after she received the vaccines, Dr. Shoenfeld did not
provide an adequate explanation for why he believed the
vaccines had caused Olivia’s GBS despite the fact that her
symptoms did not manifest themselves within the medi-
cally appropriate time period. In particular, the special
master criticized Dr. Shoenfeld’s report for providing
several possible explanations for the timing disparity, but
not saying how those explanations applied to Olivia’s
case. The special master noted that in a different case, a
neonatal immunologist had testified that children
younger than six months of age are less likely, not more
likely, to develop autoimmune reactions because their
immune systems are not strong enough to attack the host.
As for Dr. Shoenfeld’s theory of “congenital autoimmu-
nity,” the special master observed that Dr. Shoenfeld had
not identified GBS as a disease caused by congenital
autoimmunity. And as for Dr. Shoenfeld’s comment that
Olivia’s mother may have had a prior sensitization to
bacteria that accelerated Olivia’s autoimmune reaction,
1 The special master briefly alluded to the discus-
sion of adjuvants in Dr. Shoenfeld’s report, noting that
Dr. Shoenfeld had failed to identify the particular adju-
vant that he believed may have affected Olivia and that a
portion of his discussion of adjuvants related to a vaccine
that Olivia did not receive.
15 SIMANSKI v. HHS
the special master pointed out that Dr. Shoenfeld had not
identified any evidence of such sensitization on the part of
Olivia’s mother.
Speaking more generally about the flaws in Dr.
Shoenfeld’s reports, the special master pointed to “the
lack of a clearly articulated theory” of causation: If Dr.
Shoenfeld’s theory was based upon a toxic response to the
vaccine (which may happen in the case of the pertussis
vaccine), the onset of symptoms would likely be rapid, for
example within 72 hours. On the other hand, if Dr.
Shoenfeld’s theory was based on an autoimmune re-
sponse, the onset of symptoms would occur after a greater
lapse of time, as the body would require time to develop
an autoimmune reaction. The special master explained
that if Dr. Shoenfeld clarified his opinion with regard to
the theory of causation, “his opinion with regard to the
time that medical science expects to a vaccine reaction
would also become more clear.” Finally, the special
master noted that Dr. Shoenfeld did not identify which of
Olivia’s symptoms were manifestations of GBS. The
special master observed that a neurologist examined
Olivia 13 days after her vaccination and 9 days after the
date on which she began to develop symptoms of illness,
yet the results of that neurologist’s examination seemed
to be inconsistent with a dysfunction in the peripheral
nervous system. In view of that report, the special master
concluded, Dr. Shoenfeld needed to explain when Olivia
first began to manifest signs of GBS.
In light of the failure of Dr. Shoenfeld’s reports to
show a theory of causation and a temporal connection
between the vaccine and the injury (the first and third
prongs of the Althen test), the special master stated that
it was “not surprising that Dr. Shoenfeld failed to articu-
late a logical sequence of cause and effect showing that
SIMANSKI v. HHS 16
the vaccination was the reason for Olivia’s injury” (the
second prong of the Althen test). In summary, the special
master observed that “Dr. Shoenfeld’s report is more like
a general discourse about various topics instead of pre-
senting a theory for explaining how a vaccine that Olivia
received caused her GBS.”
As for Dr. Shoenfeld’s ultimate conclusion that he
could say with “great confidence and certain[t]y” that “the
vaccines with all of their immunological aspects were the
cause of” Olivia’s condition, the special master found that
assertion unsupported by “any reliable theory to explain
why a vaccine that Olivia received caused her to develop
GBS.” Without an “explicit presentation of Dr.
Shoenfeld’s opinions that fit Olivia’s case,” the special
master concluded, “there appears to be too great an
analytic gap to support Dr. Shoenfeld’s conclusion.” The
special master added that the Simanskis would be given
an opportunity to “cure these deficiencies by obtaining a
supplemental report from Dr. Shoenfeld.”
H
In response to the Order to Show Cause, the Si-
manskis again declined to submit a supplemental report
from Dr. Shoenfeld or offer any other evidence to support
their claim. Rather, they stated that they believed the
special master lacked authority to dismiss the petition for
failure to comply with the special master’s “personal order
for discovery” without considering “the remaining evi-
dence contained in the record as a whole.” They argued
that the special master had “ignore[d] the evidence in the
record” and threatened to dismiss the case “for refusing to
comply with his discovery order . . . without ever address-
ing the merits.” They contended that they had presented
sufficient evidence to establish causation and that in light
17 SIMANSKI v. HHS
of their showing, the burden should have shifted to the
respondent to refute their showing with its own expert
report. Because they claimed that they had made out a
prima facie case for compensation and the respondent
“has chosen to remain silent,” they asked that an award
be entered in their favor.
In reply to the Simanskis’ response, the respondent
argued that dismissal was an appropriate sanction for the
Simanskis’ failure to comply with the special master’s
discovery order to produce supplemental reports. The
respondent added that the special master is authorized
“to require the submission of information that is reason-
able and necessary to support a finding in petitioners’
favor,” and that the Simanskis’ failure to comply with the
special master’s directives to produce additional informa-
tion “leaves the special master with insufficient evidence
to support a finding in their favor.”
I
The special master subsequently dismissed the Si-
manskis’ petition. Simanski v. Sec’y of Health & Human
Servs., No. 03-vv-103, 2010 WL 2292200 (Fed. Cl. Spec.
Mstr. May 13, 2010). In his opinion directing the entry of
judgment for the respondent, the special master stated
that the Simanskis had not met their burden of establish-
ing the elements that are required by the Althen test to
entitle them to compensation. In particular, he stated,
Dr. Shoenfeld’s reports did not present a medical theory
causally connecting a vaccine that Olivia received with
the onset of her GBS; they did not establish a logical
sequence of cause and effect showing that the vaccination
was the reason for Olivia’s injury; and they did not estab-
lish that there was a medically appropriate time period
between Olivia’s vaccinations and the onset of her GBS.
SIMANSKI v. HHS 18
Their failure to satisfy the Althen test, he stated, “means
that the Simanskis cannot prevail.”
The special master stated that Dr. Shoenfeld’s reports
referred to what a vaccine “may” do, but did not demon-
strate that it was more likely than not that any vaccine
had caused Olivia’s condition, and that despite positing
many possibilities, Dr. Shoenfeld did not “explain what he
believes happened to Olivia.” Accordingly, the special
master dismissed the petition “for failing to comply with
the show cause order, which required the Simanskis to
produce sufficient evidence to meet the Althen prongs.”
J
The Simanskis appealed the dismissal order to the
Court of Federal Claims, arguing that the special master
had abused his discretion in dismissing the case before
requiring the respondent to submit an expert report to
counter the Simanskis’ evidence. The Court of Federal
Claims affirmed in a lengthy opinion. Simanski v. Sec’y of
Health & Human Servs., 96 Fed. Cl. 588 (2010). After
reviewing the background of the case and the applicable
legal principles in detail, the court concluded that “the
special master did not abuse his discretion in failing to
require evidence from respondent.”
The court ruled that after a Vaccine Act petitioner has
perfected his petition, the special master may proceed in
one of three ways: (1) on written submissions; (2) by
calling for a motion for summary judgment; or (3) by
holding an evidentiary hearing. The court rejected the
Simanskis’ argument that Vaccine Rule 4(c) requires the
respondent to file a report in every case. Although nor-
mally the petitioner files an expert report, the respondent
files a report, and the case then proceeds to a hearing, the
19 SIMANSKI v. HHS
court explained that in appropriate cases a petition could
be disposed of without a hearing, either on written sub-
missions or pursuant to a motion for summary judgment.
See Vaccine R. 8(a).
In this case, the court found that the special master
had decided the case on “written submissions,” not on
summary judgment, and that he had done so upon con-
cluding that the Simanskis’ evidence was “unpersuasive
in [meeting] the elements of causation-in-fact articulated
in Althen.” Thus, the court held that the special master’s
dismissal order “was not entered solely as a sanction for
failure to comply” with the special master’s orders to
supplement Dr. Shoenfeld’s report, but instead “was a de
facto analysis of the merits.” Although acknowledging
that the special master had “stepped outside the bounda-
ries of an adversarial proceeding,” the court concluded
that the Vaccine Act, which encourages the use of more
informal proceedings than ordinary civil litigation, al-
lowed the special master to do just that.
The court further concluded that the Simanskis were
not prejudiced by the manner in which the special master
proceeded. Reviewing the special master’s conduct of the
proceedings, the court ruled that the special master had
carefully considered the material facts in the record, and
that the Simanskis had failed “to pinpoint deficiencies in
the special master’s findings.” Because the Simanskis
had not shown the special master’s decision to be arbi-
trary and capricious, the court determined that it could
not disturb the special master’s findings.
In the end, the court concluded, “[w]hat is presented
in the instant case is a ruling on a procedural issue, and
the ruling calls for review of an underlying detailed
factual analysis made by the special master.” The court
SIMANSKI v. HHS 20
may do that, it explained, if the petitioner “points to
deficiencies in the special master’s analysis.” For the
petitioners to mount an adequate challenge to the special
master’s factual findings, “they must point to particular
missteps made by the special master,” and raise “specific
objections to the special master’s findings.” In this case,
because the petitioners failed to set forth their “particular
objections to the special master’s findings,” the court
sustained the special master’s ruling denying their claim.
The Simanskis then appealed to this court.
II
The Simanskis’ appeal is addressed in part to proce-
dure and in part to the merits. With regard to procedure,
the Simanskis argue that the special master should have
required the respondent to file a report under Vaccine
Rule 4(c) setting forth its position as to whether an award
should be granted. With regard to the merits, they argue
that they have satisfied their burden to show entitlement
to compensation, that it was error for the special master
to find that they failed to establish a prima facie case, and
that this court should rule as a matter of law that they
are entitled to compensation.
A
Vaccine Rule 4(c)(1) provides as follows:
Within 90 days after the filing of a petition, or in
accordance with any schedule set by the special
master after petitioner has satisfied all required
documentary submissions, respondent must file a
report setting forth a full and complete statement
21 SIMANSKI v. HHS
of its position as to why an award should or
should not be granted.
The Simanskis argue that they perfected their petition by
filing Olivia’s medical records and their experts’ reports.
Once they had completed that step, they argue, the re-
spondent was required to file a Rule 4(c) report. The
respondent’s failure to file such a report was prejudicial to
them, the Simanskis argue, because the report might
have conceded their claim or at least narrowed the dis-
pute between the parties.
The Court of Federal Claims rejected the Simanskis’
interpretation of Rule 4(c). The court ruled that under
Rule 4(c)(1) the intended course of action in most cases is
for the respondent to file a report after the perfection of
the petition, but that the special master is authorized by
the statute and the Vaccine Rules “to pretermit the need
for respondent to set forth its statement of position” in
appropriate cases. Besides the broad authority granted to
special masters to conduct proceedings in Vaccine Act
cases, the court explained, Rule 4(c)(1) itself provides that
the filing of the respondent’s report is subject to the
scheduling discretion of the special master.
In this case, the respondent indicated at several
points that it intended to file a motion for summary
judgment. In such a case, the Court of Federal Claims
held, the respondent can move for summary judgment
before filing a report if the respondent believes that the
evidence submitted by the petitioner would be insufficient
to support a compensation award. As directed by the
Vaccine Act, 42 U.S.C. § 300aa-12(d)(2)(C), Rule 8(d) of
the Vaccine Rules provides that the special master may
decide a case on the basis of written submissions, includ-
ing a motion for summary judgment. Rule 8(d) states
SIMANSKI v. HHS 22
that such motions are governed by the procedures of Rule
56 of the Rules of the Court of Federal Claims, which is
substantively similar to Rule 56 of the Federal Rules of
Civil Procedure.
A party moving for summary judgment under Rule 56
of the Federal Rules of Civil Procedure or the Rules of the
Court of Federal Claims is not necessarily required to
submit evidence in support of its motion. Instead, when
the non-moving party bears the burden of proof on an
issue, the moving party can simply point out the absence
of evidence creating a disputed issue of material fact. The
burden then falls on the non-moving party to produce
evidence showing that there is such a disputed factual
issue in the case. See Celotex Corp. v. Catrett, 477 U.S.
317, 325 (1986); Dairyland Power Coop. v. United States,
16 F.3d 1197, 1202 (Fed. Cir. 1994). Applying those
principles in the context of a Vaccine Act case means that
the respondent may move for summary judgment without
having filed evidence, in the form of a report or otherwise,
contesting the petition.
Because the Vaccine Rules contemplate the use of
summary judgment procedures based on the practice
under Rule 56, we agree with the Court of Federal Claims
that Vaccine Rule 4(c) does not require the respondent to
file a report in every case after the petitioner has per-
fected his or her petition. For the same reason, we reject
the Simanskis’ related argument that they were entitled
to refuse to comply with the special master’s order to
produce a supplemental report from Dr. Shoenfeld be-
cause the special master “lacked the authority [to] sus-
pend respondent’s Rule 4(c) report” once the Simanskis
had perfected their petition.
23 SIMANSKI v. HHS
B
On the merits, the Simanskis argue that the evidence
of record required the special master to award compensa-
tion in this case and that this court should direct the
entry of judgment in their favor on remand. They contend
that their evidence satisfies each of the Althen factors and
that, in the absence of evidence from the respondent
showing a different cause for Olivia’s condition, they have
met their burden of proving causation by a preponderance
of the evidence.
The Simanskis’ request for a ruling on the merits is
premature. It was within the authority of the special
master to suspend the respondent’s time for complying
with Vaccine Rule 4(c). As a result, the respondent has
not waived its right to file a responsive report setting
forth its evidence and presenting its arguments in re-
sponse to the petition and the evidence the Simanskis
have introduced into the record. In light of the fact that,
despite its lengthy pendency, this case is still at an early
procedural stage and the respondent has not been called
upon to present its position with respect to the petition
and the supporting evidence, it would be inappropriate for
us to hold at this point that the Simanskis are entitled to
compensation under the Act.
C
To conclude that the Simanskis are not entitled to the
entry of a compensation award at this time does not, of
course, answer the question whether it was error for the
special master to dismiss the petition without a hearing.
To answer that question, we must address the scope of a
special master’s authority to dismiss a petition when the
petitioner fails to respond to the special master’s requests
SIMANSKI v. HHS 24
for additional information. As indicated below, we believe
that notwithstanding the broad statutory grant of discre-
tion to the special masters in conducting Vaccine Act
proceedings, there is a limit to their power to dismiss
petitions for failure to comply with orders to produce
additional information. We hold that in this case the
special master exceeded that limit.
1
The Court of Federal Claims correctly noted that by
statute special masters are entrusted with considerable
authority over discovery and the production of evidence in
Vaccine Act cases. The Act provides that in conducting a
proceeding on a compensation petition, a special master
may require “such evidence as may be reasonable and
necessary,” may require “the submission of such informa-
tion as may be reasonable and necessary,” and may
require “the testimony of any person and the production
of any documents as may be reasonable and necessary.”
42 U.S.C. § 300aa-12(d)(3)(B). Moreover, the statute
provides that there may be “no discovery in a proceeding
on a petition other than the discovery required by the
special master.” Id.; see Whitecotton v. Sec’y of Health &
Human Servs., 81 F.3d 1099, 1108 (Fed. Cir. 1996) (noting
that “the permissible scope of the special master’s inquiry
is virtually unlimited”). Accordingly, orders to produce
supplemental information of the sort issued by the special
master in this case are well within the special master’s
authority.
In appropriate circumstances, an unjustified failure to
comply with a lawful order of a special master can result
in dismissal of the petition, just as dismissal can be
ordered for failure to prosecute a petition. See Vaccine R.
21(b)(1) (authorizing dismissal of a petition for failure to
25 SIMANSKI v. HHS
comply with an order of the special master or the court).
Similarly, in ordinary civil litigation dismissal is one of
the sanctions that can be used in cases of discovery viola-
tions, see Nat’l Hockey League v. Metro. Hockey Club, Inc.,
427 U.S. 639, 643 (1976) (per curiam), although the
ultimate sanction of dismissal of a claim with prejudice
has been reserved for extreme cases, whether in the
context of discovery or litigation misconduct, see Micron
Tech., Inc. v. Rambus Inc., 645 F.3d 1311, 1328 (Fed. Cir.
2011); Univ. of Pittsburgh v. Varian Med. Sys., Inc., 569
F.3d 1328, 1334 (Fed. Cir. 2009).
We do not believe the sanction of dismissal with
prejudice was warranted on the facts of this case. The
special master regarded both Dr. Shoenfeld’s initial report
and his supplemental report as raising questions about
whether the Simanskis had met their burden to show
causation. In his first order, the special master related
that the Simanskis were “comfortable resting on Dr.
Shoenfeld’s [first] report, and did not want to obtain a
supplemental report.” Nonetheless, the special master
“afforded [them] an opportunity to review the record” and
then to advise the special master “how they would like the
case to proceed.” The special master added the following:
If the Simanski[s] believe that the existing record
supports a finding that they have met their bur-
den, the respondent has indicated that he will file
a motion for summary judgment and seek a ruling
before obtaining an expert report. Alternatively,
the Simanskis may wish to obtain a supplemental
report from Dr. Shoenfeld.
That order was not couched as a directive to supplement
Dr. Shoenfeld’s report, but rather as offering the Si-
SIMANSKI v. HHS 26
manskis a choice whether to file additional evidence or to
proceed on the record they had made to that point.
When the Simanskis submitted their supplemental
report from Dr. Shoenfeld, the special master found that
report to be insufficient and stated that the Simanskis
“are given another opportunity to present an additional
report from Dr. Shoenfeld.” The special master noted
that “[b]efore respondent assesses the petitioners’ case,
petitioners and Dr. Shoenfeld should make as complete
[a] disclosure as possible. More information from Dr.
Shoenfeld is especially advantageous . . . because during
the April 13, 2009 status conference, respondent stated
that it intended to file a motion for summary judgment.”
The special master added that “if the case proceeds to a
hearing, a written disclosure of all of Dr. Shoenfeld’s
opinions will allow respondent and [the special master] to
prepare for the hearing. A written disclosure will also
eliminate any surprise testimony and thereby increase
the likelihood that the hearing can be completed in one
session.” Again, the special master’s order was couched
as providing the Simanskis with an opportunity to sup-
plement the record, not as a directive insisting that they
do so. 2
2 That order included a sentence reading, “As pre-
viously stated, the petitioners are ordered to file a second
supplemental report from Dr. Shoenfeld by Friday, July
24, 2009.” That sentence alludes to the prior provision of
the order giving the petitioners “another opportunity to
present an additional report from Dr. Shoenfeld” and
setting forth the deadline for filing that report. We do not
interpret the quoted sentence as requiring the Simanskis
to file such a report, but rather as setting the deadline by
which any such report must be filed.
27 SIMANSKI v. HHS
In the subsequent Order to Show Cause, the special
master characterized the two previous orders differently.
He stated that the Simanskis had “failed to comply with
the April 13, 2009 order and the June 26, 2009 order,
which required the Simanskis to obtain a supplemental
expert report.” The special master alluded to “several
unrecorded status conferences” at which the special
master had “discussed the reasons the Simanskis should
obtain a supplemental expert report,” but he relied on the
Simanskis’ “refus[al] to comply” with the April 13, 2009,
and June 26, 2009, orders as the basis for issuing the
Order to Show Cause. In response to the Order to Show
Cause, the Simanskis argued that the respondent should
be required to file a report in response to their petition,
and they requested that the special master proceed to rule
on the compensation issue.
While the Order to Show Cause contained more direc-
tory language than the special master’s two prior orders,
even the Order to Show Cause invited the Simanskis to
supplement Dr. Shoenfeld’s report in order to avoid
dismissal on the merits. It explained that “this order
presently gives the Simanskis an opportunity to cure any
gaps in Dr. Shoenfeld’s opinion,” and added that if the
Simanskis “present a supplemental response from Dr.
Shoenfeld that addresses the concerns in this show cause
order, their case will be improved and the case will con-
tinue.”
Under these circumstances, we hold that the special
master should not have dismissed the petition as a sanc-
tion for the Simanskis’ failure to comply with the orders
to supplement Dr. Shoenfeld’s report. To be sure, it was
entirely reasonable for the special master to suggest that
the Simanskis supplement Dr. Shoenfeld’s report, both to
provide better support for their claim and to allow the
SIMANSKI v. HHS 28
respondent and the special master to prepare for the
hearing. However, having given the Simanskis the option
to supplement the report or face a summary judgment
motion or a dismissal on the merits based on the record as
it stood, the special master should not have dismissed the
petition for noncompliance with the prior orders when
they elected to stand on Dr. Shoenfeld’s original report
and his supplemental letter.
Apart from the particular circumstances of this case,
if a Vaccine Act petitioner has produced what the peti-
tioner believes is enough evidence to prevail, or at least to
proceed to a hearing, the petitioner is normally entitled to
a ruling on that question. If the petitioner cannot pro-
duce additional evidence in response to a special master’s
order—or chooses not to do so—the petitioner may be at
risk of an adverse ruling on the merits, but that ruling
should be based on the merits and not on the petitioner’s
failure to come forward with additional evidence.
In such a case, if the respondent believes the peti-
tioner’s evidence is insufficient to set forth facts that
could justify a compensation award, the proper course is
for the respondent to move for summary judgment, as the
respondent indicated it was prepared to do in this case.
In ruling on that motion, the special master can decide
whether the petitioner’s evidence is sufficient to allow the
matter to proceed to a hearing. If the special master
denies summary judgment and orders the case to proceed
to a hearing, and the special master is concerned that the
petitioner’s expert may seek to testify to matters beyond
the scope of his expert report, there are several measures
the special master can employ to minimize that risk.
First, the special master can order the experts to confine
their testimony to the issues addressed in their reports.
Second, the special master can insist on a proffer of the
29 SIMANSKI v. HHS
experts’ testimony well in advance of the hearing. Third,
the special master can order some form of discovery from
the experts prior to the hearing. However, in a case such
as this one, where the question is whether the petitioners’
evidence is sufficient to survive a summary judgment
motion by the respondent, it is ordinarily not appropriate
for the special master to dismiss the petition as a sanction
for the petitioners’ failure to comply with a directive to
produce additional evidence in support of their claim.
2
As the Court of Federal Claims pointed out, the spe-
cial master’s Order to Show Cause contained a detailed
assessment of the merits of the case, which the special
master included as part of his analysis of whether any
less severe sanction would be appropriate for the Si-
manskis’ failure to comply with his invitations to supple-
ment Dr. Shoenfeld’s report. Based on his analysis of the
merits, the special master concluded that Dr. Shoenfeld’s
two reports “fail to meet the petitioners’ burden of produc-
ing persuasive evidence” on each of the three parts of the
Althen test for proving causation in an off-Table case.
Besides arguing that the special master was author-
ized to dismiss the petition for failure to comply with the
special master’s orders, the respondent contends that the
special master addressed the merits of the Simanskis’
claim and correctly held their evidence insufficient to
satisfy the three parts of the Althen test. The Court of
Federal Claims agreed that the special master addressed
the merits of the case and concluded that the “petitioners’
information [was] unpersuasive in [meeting] the elements
of causation-in-fact articulated in Althen.” The court
noted, however, that in reaching that conclusion, the
special master “did not afford petitioners review under
SIMANSKI v. HHS 30
the summary judgment standard that would give them
the benefit of all inferences,” and that the special master
“directly analyz[ed] the merits of the case without calling
for a statement of position from respondent or without
calling for a motion for summary judgment.” In so doing,
the Court of Federal Claims stated, “the special master in
the instant case stepped outside the boundaries of an
adversarial proceeding.” However, in view of the broad
authority granted to special masters in conducting vac-
cine compensation proceedings, the court concluded that
“the Vaccine Act allows him to do just that.”
On this point, we disagree with the Court of Federal
Claims. The manner in which the special master ad-
dressed the merits amounted to making a decision in the
case on written submissions, but not applying summary
judgment standards and not conducting a hearing on the
claim. As a result, the issues of the sufficiency of the
evidence and the Simanskis’ failure to comply with the
special master’s directives became intertwined in this
case in a way that obscured the question whether the
Simanskis had proffered sufficient evidence to survive
summary judgment and entitle them to a hearing on the
merits of their claim.
The special master focused on the perceived inade-
quacies in Dr. Shoenfeld’s theory of causation, but his
analysis was not couched as an inquiry into whether the
Simanskis had made a sufficient showing of causation to
withstand summary judgment. In particular, in discuss-
ing the Althen factors the special master appears to have
demanded more from the petitioners than would be
required in a conventional summary judgment proceed-
ing. For example, in addressing whether the Simanskis
had provided “a medical theory causally connecting the
vaccination and the injury,” Althen, 418 F.3d at 1278, the
31 SIMANSKI v. HHS
special master objected to Dr. Shoenfeld’s report on
various grounds. One ground was that Dr. Shoenfeld had
stated that a vaccine “may induce autoimmunity.” That
statement was insufficient to satisfy the “medical theory”
requirement, the special master ruled, because it was not
sufficient to establish, by a preponderance of the evidence,
that the vaccine did cause autoimmunity in Olivia.
The special master also criticized Dr. Shoenfeld for
failing to present a “clearly articulated theory” of how the
vaccines in question caused Olivia’s GBS, including
“identification and proof of specific biological mecha-
nisms.” That was too demanding a standard. Although a
finding of causation “must be supported by a sound and
reliable medical or scientific explanation,” causation “can
be found in vaccine cases . . . without detailed medical
and scientific exposition on the biological mechanisms.”
Knudsen v. Sec’y of the Dep’t of Health & Human Servs.,
35 F.3d 543, 548-49 (Fed. Cir. 1994). It is not necessary
for a petitioner to point to conclusive evidence in the
medical literature linking a vaccine to the petitioner’s
injury, as long as the petitioner can show by a preponder-
ance of the evidence that there is a causal relationship
between the vaccine and the injury, whatever the details
of the mechanism may be. Moberly, 592 F.3d at 1325;
Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367,
1378 (Fed. Cir. 2009).
Likewise, in addressing whether the Simanskis had
shown “a proximate temporal relationship between vacci-
nation and injury,” Althen, 418 F.3d at 1278, the special
master noted that Olivia’s respiratory failure had oc-
curred one day earlier than would be expected according
to the medical literature. Dr. Shoenfeld sought to explain
why in Olivia’s case an earlier date of onset was not
inconsistent with a vaccine-related injury, but the special
SIMANSKI v. HHS 32
master found his explanation insufficient to satisfy that
prong of the Althen test. This court has explained that
requiring a “temporal relationship” between the vaccina-
tion and the injury is designed to ensure that it is “medi-
cally acceptable to conclude that the vaccination and the
injury are causally linked.” De Bazan v. Sec’y of Health &
Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
While the special master’s critique of Dr. Shoenfeld’s
explanations for the early onset is thorough and may
ultimately be convincing, we think Dr. Shoenfeld’s expla-
nations were sufficient at least to present a factual dis-
pute as to that issue from which a trier of fact could
conclude that the one-day variance in the time of onset of
Olivia’s symptoms is not inconsistent with a vaccine-
related injury.
As a final point regarding the special master’s analy-
sis of Dr. Shoenfeld’s report, the special master observed
that while Dr. Shoenfeld had stated that a vaccine “may
induce autoimmunity,” he did not state that a vaccine
received by Olivia “did induce autoimmunity in Olivia,”
and that if he “holds that opinion, then the Simanskis
should file a supplemental report from Dr. Shoenfeld” to
that effect. To the extent that the special master was
concerned that Dr. Shoenfeld had failed to state his
opinion as to whether a vaccine had induced autoimmu-
nity in Olivia, a fair reading of his initial report makes it
clear that he holds that opinion. In the report, he stated
that “GBS is a clinical autoimmune disease” and that “the
vaccines with all their immunological aspects were the
cause of [Olivia’s] GBS/CIPD.” While the support in the
report for that conclusion may be inadequate to compel
the grant of relief based on the evidence of record at this
time, as noted above, the conclusion at least makes clear
that Dr. Shoenfeld believes that a vaccine induced auto-
immunity in Olivia.
33 SIMANSKI v. HHS
In sum, we conclude that while special masters are
given broad authority over the manner in which they
conduct Vaccine Act proceedings, that authority may not
be used in a way that deprives a party of procedural
rights provided by the Vaccine Act and the Vaccine Rules,
such as the rights attendant to conventional summary
judgment procedures. See Jay v. Sec’y of the Dep’t of
Health & Human Servs., 998 F.2d 979, 983 (Fed. Cir.
1993).
3
While we agree with the Simanskis that the dismissal
order in this case should be overturned, we do not endorse
the extended remarks in the Simanskis’ brief accusing the
special master of “‘cross[ing] the line’ from being an
impartial jurist, to being an advocate for the respondent”
and having a “predisposition to find against Olivia.” As
we have noted, it was entirely reasonable for the special
master to suggest that the Simanskis supplement Dr.
Shoenfeld’s initial report.
III
Because we conclude that the special master should
not have dismissed the Simanskis’ petition due to their
failure to supplement Dr. Shoenfeld’s reports, and be-
cause the special master’s analysis of the merits should
have been conducted in accordance with conventional
summary judgment standards, we reverse the judgment
of the Court of Federal Claims. We remand with instruc-
tions for the special master to address the merits of the
Simanskis’ claim, either by applying appropriate sum-
mary judgment standards or by conducting a hearing and
resolving the compensation claim on the merits.
SIMANSKI v. HHS 34
REVERSED and REMANDED