United States Court of Appeals
for the Federal Circuit
__________________________
JENNIFER STONE AND GARY STONE,
PARENTS AND NEXT FRIENDS OF
AMELIA STONE, A MINOR,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________
2011-5109
__________________________
Appeal from the United States Court of Federal
Claims in Case No. 04-VV-1041, Senior Judge Lawrence
S. Margolis.
--------------------------------------------
__________________________
SCOTT R. HAMMITT,
AS THE LEGAL REPRESENTATIVE OF HIS
MINOR DAUGHTER,
RACHEL HAMMITT,
Petitioner-Appellant,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
STONE v. HHS 2
Respondent-Appellee.
__________________________
2011-5117
__________________________
Appeal from the United States Court of Federal
Claims in Case No. 07-VV-170, Judge Thomas C.
Wheeler.
___________________________
Decided: April 26, 2012
___________________________
RICHARD GAGE, Richard Gage, P.C., of Cheyenne,
Wyoming, argued for petitioners-appellants in appeal no.
2011-5109.
CURTIS R. WEBB, of Twin Falls, Idaho, argued for peti-
tioner-appellant in appeal no. 2011-5117.
ALEXIS B. BABCOCK, Trial Attorney, Torts Branch,
Civil Division, United States Department of Justice, of
Washington, DC, argued for respondent-appellee in
appeal no. 2011-5109. With her on 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.
ALTHEA W. DAVIS, Senior Trial Counsel, Torts Branch,
Civil Division, United States Department of Justice, of
Washington, DC, argued for respondent-appellee in
appeal 2011-5117. With her on the brief were TONY
WEST, Assistant Attorney General, MARK W. ROGERS,
3 STONE v. HHS
Acting Director, VINCENT J. MATANOSKI, Acting Deputy
Director, and GABRIELLE M. FIELDING, Assistant Director.
__________________________
Before RADER, Chief Judge, SCHALL and BRYSON, Circuit
Judges.
BRYSON, Circuit Judge.
In separate proceedings, petitioners Jennifer and
Gary Stone and petitioner Scott Hammitt sought compen-
sation under the National Vaccine Injury Compensation
Program for injuries to their children allegedly caused by
the Diptheria-Tetanus-acellular Pertussis (“DTaP”)
vaccine. The Stones alleged that the administration of
the DTaP vaccine to their daughter Amelia was a sub-
stantial cause of a seizure disorder from which she suf-
fers, known as Severe Myoclonic Epilepsy of Infancy
(“SMEI”). 1 Mr. Hammitt made the same allegation with
respect to his daughter Rachel, who also suffers from
SMEI. The same special master presided over both cases
and determined that the petitioners failed to show enti-
tlement to compensation because in both cases the evi-
dence showed that a gene mutation present in both
children was the sole cause of their injuries. The Court of
Federal Claims affirmed both decisions.
1 SMEI is also known as Dravet Syndrome. As the
special master explained, it is an epilepsy syndrome that
“begins in the first year of life in previously healthy
children. Hemiclonic seizures, which may be long lasting,
are characteristic and can be associated with fever.
Myoclonic, absence, tonic-clonic, and partial seizures also
occur. The epilepsy is refractory and developmental
regression ensues.” Stone v. Sec’y of Health & Human
Servs., No. 04-1041V, at 1 n.2 (Fed. Cl. Spec. Mstr. Apr.
15, 2010).
STONE v. HHS 4
I
A
Amelia Stone was born on April 17, 2001, and re-
ceived a DTaP vaccination on August 27, 2001. The day
after her DTaP vaccination, Amelia experienced a febrile
seizure. She was treated at a hospital and released
several days later. The special master and the trial court
found that Amelia suffered no brain damage as a result of
the seizure. On September 26, 2001, Amelia experienced
a second febrile seizure. She was again treated at the
hospital, and no evidence of brain damage was discovered.
Amelia continued to experience seizures, both febrile
and afebrile. At a check-up on December 19, 2001, her
doctor noted that “[i]t appears now that [Amelia] has a
primary seizure disorder,” but that her “neurologic devel-
opment has been appropriate.” In October 2003, Amelia’s
seizure disorder was diagnosed as SMEI. In January
2005, genetic testing revealed that Amelia has a de novo
mutation in her SCN1A gene. The records accompanying
the results noted that “[t]his finding is most consistent
with this DNA variant being associated with a severe
phenotype (SMEI or SMEB) rather than a mild or normal
phenotype.”
B
Rachel Hammitt was born on November 9, 2003. She
received her second DTaP, IPV, Hepatitis B, Hib, and
Pneumococcal Conjugate vaccinations on March 15, 2004.
That evening, Rachel experienced a febrile seizure. She
was treated at a hospital and released several days later.
The special master and the trial court found that Rachel
suffered no brain damage as a result of that seizure. On
5 STONE v. HHS
April 22, 2004, Rachel experienced a second seizure. She
was again treated at the hospital and released several
days later.
Thereafter, Rachel continued to experience intermit-
tent seizures. Records from her 12-month check-up on
November 12, 2004, showed a diagnosis of epilepsy but
reported normal growth and development. However, at
her 14-month checkup, Rachel’s pediatrician recorded
delayed verbal and gross motor development and recom-
mended that she be evaluated for global developmental
delays. Genetic testing ordered on May 3, 2005, revealed
that Rachel has a mutation in her SCN1A gene. The
records accompanying the results stated that the muta-
tion is “associated with a severe phenotype (SMEI or
SMEB) rather than a mild or normal phenotype.” At a
follow-up appointment, a physician noted that Rachel’s
“clinical course, EEG, and SCN1A test . . . are suggestive
of [SMEI].”
C
The petitioners in both cases sought compensation
under the National Childhood Vaccine Injury Act, 42
U.S.C. §§ 300aa-1 to 300aa-34 (“Vaccine Act”), alleging
that the DTaP vaccination was a substantial cause of
each child’s SMEI. The evidence submitted to the special
master in both cases was largely the same, and much of
it—including key testimony for the respondent concerning
the SCN1A gene mutation—was presented in a single
consolidated hearing. Dr. Marcel Kinsbourne testified for
the petitioners. He testified that in both cases the DTaP
vaccinations were a substantial contributing cause of the
SMEI. He explained his theory of causation as follows:
“The DTaP vaccine[s] [received by Amelia and Rachel]
caused [each of them] to have a fever; that fever caused a
STONE v. HHS 6
prolonged seizure classified as a complex febrile seizure;
and that seizure damaged [the] brain, lowering [the] level
of seizure propensity, thus facilitating further seizures.”
However, Dr. Kinsbourne agreed that “a trigger doesn’t
necessarily have to have a further deeper impact,” and he
admitted that he had simply “inferred” that the children
had suffered brain damage from the fact of their initial
seizures. He agreed that there was no clinical manifesta-
tion of the inferred brain damage in either case.
In support of his theory, Dr. Kinsbourne relied on a
series of medical articles, which the special master did not
find persuasive. Some of the articles on which Dr. Kins-
bourne relied concerned the DTP vaccine, rather than the
DTaP vaccine. The special master found those articles
unhelpful because neurological reactions to the two dif-
ferent vaccines “do not occur with the same frequency, nor
[do they present] the same relative risks.” Dr. Kins-
bourne also relied on an article by Berkovic et al. to
support his theory. The special master, however, found
that the Berkovic article supported the respondent’s
position, not Dr. Kinsbourne’s theory, because the authors
of that article did not find that vaccines are a “trigger for
encephalopathy” as Dr. Kinsbourne argued. Instead, that
article concluded that individuals with certain mutations
in the SCN1A gene “seem to develop SMEI or SMEB [a
related seizure condition] whether or not they are immu-
nized in the first year of life. We do not think that avoid-
ing vaccination, as a potential trigger, would prevent
onset of this devastating disorder in patients who already
harbour the SCN1A mutation.”
In evaluating Dr. Kinsbourne’s testimony and qualifi-
cations, the special master expressed concern “regarding
Dr. Kinsbourne’s reliability as an expert witness” due to
the fact that Dr. Kinsbourne “has not maintained a hospi-
7 STONE v. HHS
tal based clinical pediatric neurology practice since 1981.”
The special master noted that Dr. Kinsbourne’s testimony
“reflected his lack of recent clinical practice,” and that
“[h]is testimony was highly generalized and lacked any
grounding in practice.” He also noted that “Dr. Kins-
bourne does not publish, research, teach, counsel, attend
meetings or conferences, or have any special training in
the field of genetics.” The special master concluded that
“[t]he fact that for the past twenty-five years Dr. Kins-
bourne has not focused his practice, research, or teaching
in the field of seizure disorders, and that Dr. Kinsbourne
has no expertise in the field of genetics significantly
limited his ability to offer reliable, persuasive, and cogent
testimony in this case.” Although the special master
encouraged the petitioners to submit expert testimony
from a geneticist, they declined to do so and relied solely
on Dr. Kinsbourne.
Three experts testified for the respondent. In Amelia
Stone’s case, Dr. Michael Kohrman and Dr. Gerald Ray-
mond testified for the respondent. In Rachel Hammitt’s
case, Dr. Max Wiznitzer and Dr. Raymond testified for
the respondent. The special master found the testimony
of each of those witnesses to be helpful, but was particu-
larly persuaded by Dr. Raymond, who has a background
in both pediatric neurology and genetics. In his opinions
in both cases, the special master stated: “Dr. Raymond’s
knowledge and experience with neurology and clinical
genetics is extensive. His essentially unrebutted testi-
mony was very persuasive and was relied upon heavily in
deciding this case.”
Dr. Raymond testified that the SCN1A gene mutation
was the sole cause of SMEI in both Amelia and Rachel.
He testified at length as to how he reached that conclu-
sion, beginning with the fact that SMEI is highly corre-
STONE v. HHS 8
lated with a mutation in the SCN1A gene. All three of
the respondent’s experts further testified that there was
no evidence that either Amelia or Rachel suffered brain
damage as a result of their initial febrile seizures. The
respondent’s experts concluded that there was no evi-
dence that the initial seizures contributed in any way to
either child’s SMEI.
Dr. Kinsbourne agreed that “SMEI has a genetic
bas[is]” that is “very powerful,” but he contended that “the
pertussis vaccine caused fever, the fever triggered the
seizure, [and] the seizure lasted a long time,” thereby
lowering each child’s seizure threshold. As summarized
by the special master in the Stone case, Dr. Kinsbourne’s
rebuttal essentially consisted of:
1) criticizing the testimony presented by Dr.
Raymond regarding the factors a geneticist ana-
lyzes in determining a genotype-phenotype rela-
tionship; 2) arguing that the SCN1A gene
mutation is not a reliable indicator of clinical out-
come; 3) arguing that the scientific literature sup-
ports an environmental (vaccine role) in
causation; 4) arguing that the vaccine was respon-
sible for the first seizure, which was a complex
febrile seizure, and complex febrile seizures dam-
age the brain; 5) arguing that the [special mas-
ter’s] prior rulings in [two similar cases] require a
finding on behalf of petitioners; and 6) criticizing
Dr. Raymond’s qualifications.
D
After considering all the evidence, the special master
concluded that neither Amelia nor Rachel was entitled to
compensation. He determined that the respondent had
9 STONE v. HHS
demonstrated by a preponderance of the evidence that the
SCN1A gene mutation was “more likely than not the ‘but
for’ and ‘substantial factor’ that caused” the SMEI in both
children. Stone v. Sec’y of Health & Human Servs. (Stone
I), No. 04-1041V (Fed. Cl. Spec. Mstr. Apr. 15, 2010);
Hammitt v. Sec’y of Health & Human Servs. (Hammitt I),
No. 07-170V (Fed. Cl. Spec. Mstr. Aug. 31, 2010).
The special master noted that the “issue that ulti-
mately must be resolved is whether respondent demon-
strated that the mutation is the substantial causal factor,
or in other words that the vaccine did not also play a
substantial causal role in [the children’s] SMEI.” Stone I
at 48; Hammitt I at 50. As to that question, the special
master wrote that “[t]here is simply no evidence that
[either child’s] initial seizure caused any brain damage, or
somehow affected the expression of her genetic mutation
in such a way that caused her to develop SMEI or experi-
ence further seizures.” Stone I at 48; Hammitt I at 50.
Dr. Kinsbourne, the special master found, “was unable to
point to any evidence demonstrating that [either child’s]
vaccination acted as anything more than a trigger to her
initial fever-induced seizure.” Stone I at 48; Hammitt I at
50. He was “unable to point to any evidence that [either
child’s] initial febrile seizure caused her injury, which
when combined with her mutation was a substantial
cause of her SMEI.” Stone I at 48; Hammitt I at 50. In
Rachel’s case, the special master stated that he found
“compelling” Dr. Raymond’s contrary testimony that
based on the mutation in her SNC1A gene, she was “going
to have [SMEI],” and that “[e]xcept for her having a
seizure with fever,” the DTaP vaccination “had no signifi-
cant role in the development of her having [SMEI].”
Hammitt I at 50. In Amelia’s case, the special master
stated that the evidence supported Dr. Raymond’s opinion
“that the initial fever-induced seizure was part of the
STONE v. HHS 10
normal progression of Amelia’s SMEI,” which was “com-
pletely unrelated to the fact that she had an immuniza-
tion that day.” Stone I at 48-49. Accordingly, the special
master concluded that in both cases the petitioners had
“failed to present evidence that the vaccine-induced
seizure caused injury to [the child’s] brain,” and that the
respondent had “met the burden of proving a factor unre-
lated to the vaccination caused [the children’s] SMEI.”
Stone I at 51; Hammitt I at 53.
On review in the Court of Federal Claims, both re-
viewing judges remanded for further findings. The re-
viewing judge in the Hammitt case concluded that the
special master had not specifically stated whether the
petitioners had presented a prima facie case and, if so,
whether the respondent had proved that the SCN1A gene
mutation was the “sole substantial factor” in causing
Rachel’s SMEI. Hammitt v. Sec’y of Health & Human
Servs., No. 07-170V (Fed. Cl. Dec. 22, 2010). The review-
ing judge in the Stone case concluded that the special
master had not made an express determination that the
genetic mutation was the sole cause of Amelia’s SMEI.
Stone v. Sec’y of Health & Human Servs., No. 04-1041V
(Fed. Cl. Oct. 28, 2010).
On remand, the special master wrote supplemental
opinions in which he made specific findings on the issues
identified in the remand opinions. In the Hammitt case,
the special master concluded that the petitioner had not
made a prima facie case under the applicable standard,
regardless of whether the evidence of the effect of the
SNC1A mutation was considered in assessing the prima
facie case. He also concluded that, even if the petitioner’s
evidence were sufficient to make out a prima facie case for
compensation, the government had satisfied the require-
ments of the “factors unrelated” defense of section
11 STONE v. HHS
13(a)(1)(B) of the Vaccine Act, which provides that com-
pensation will not be awarded if the special master finds
that there is “a preponderance of the evidence that the
[injury] is due to factors unrelated to the administration
of the vaccine.” 42 U.S.C. § 300aa-13(a)(1)(B).
In the Stone case, the special master wrote:
Based upon Dr. Raymond’s expertise and vastly
superior testimony, Dr. Kinsbourne’s unfortu-
nately very weak testimony, the presence of ge-
netic factors that when considered cumulatively
by a geneticist enable the geneticist to opine to a
genetic cause, and the absence of evidence that
the complex febrile seizure actually injured the
brain, the undersigned is convinced beyond any
doubt that respondent proved by a preponderance
of the evidence that [the] SCN1A gene mutation
was the sole cause and was principally responsible
for [the] SMEI.
Stone v. Sec’y of Health & Human Servs. (Stone II), No.
04-1041V, at 4 (Fed. Cl. Spec. Mstr. Jan. 20, 2011). The
special master made the same finding in the Hammitt
case, using nearly identical language. Hammitt v. Sec’y of
Health & Human Servs. (Hammitt II), No. 07-170V, at 10
(Fed. Cl. Spec. Mstr. Mar. 4, 2011). The reviewing judges
of the Court of Federal Claims affirmed the special mas-
ter’s ruling in both cases. Hammitt v. Sec’y of Health &
Human Servs., No. 07-170V (Fed. Cl. June 23, 2011);
Stone v. Sec’y of Health & Human Servs., No. 04-1041V
(Fed. Cl. May 19, 2011).
The Stones and Mr. Hammitt filed separate appeals.
We consider the two appeals together because of the
STONE v. HHS 12
substantial overlap of the evidence and issues in the two
cases.
II
Both the Stones and Mr. Hammitt argue that the spe-
cial master erred by failing to apply the proper causation
principles when analyzing the effect of the DTaP vaccina-
tions in causing the children’s SMEI. The petitioners
argue that the special master should have applied the
doctrine of “superseding cause” set forth in the Second
Restatement of Torts and that under that standard, they
would have been entitled to compensation.
For cases involving injuries that do not fall within the
Vaccine Injury Table, 42 U.S.C. § 300aa-14(a)—the so-
called “off-Table” cases—the petitioner has the burden to
prove causation by a preponderance of the evidence. 42
U.S.C. § 300aa-13(a)(1)(A); Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1321-22 (Fed. Cir. 2010);
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2005). To prove causation, a petitioner
must show that the vaccine was “not only a but-for cause
of the injury but also a substantial factor in bringing
about the injury.” Shyface v. Sec’y of Health & Human
Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999). We have
held that the causation standard in off-Table Vaccine Act
cases is to be applied consistently with the principles set
forth in the Second Restatement of Torts. Walther v. Sec’y
of Health & Human Servs., 485 F.3d 1146, 1151 (Fed. Cir.
2007), citing Shyface, 165 F.3d at 1351. As noted, the
statute further provides that a petitioner is not entitled to
compensation if the special master or the court finds that
the injury is “due to factors unrelated to the administra-
tion of the vaccine.” 42 U.S.C. § 300aa-13(a)(1)(B).
13 STONE v. HHS
As special masters have observed in this and other
cases, see, e.g., Heinzelman v. Sec’y of Health & Human
Servs., No 07-01V (Fed. Cl. Spec. Mstr. Dec. 11, 2008),
interpretations of the Vaccine Act have given rise to some
confusion as to the order of proof regarding causation in
off-Table cases. In particular, the question has arisen
whether, in assessing whether a prima facie showing of
causation has been made in an off-Table case, a special
master may consider evidence of other possible causes for
the injury in question, or whether evidence of other
possible causes may be considered only in connection with
the “factors unrelated” defense on which the government
has the burden of proof.
Our decisions support the commonsense proposition
that evidence of other possible sources of injury can be
relevant not only to the “factors unrelated” defense, but
also to whether a prima facie showing has been made that
the vaccine was a substantial factor in causing the injury
in question. See, e.g., De Bazan v. Sec’y of Health &
Human Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The
government, like any defendant, is permitted to offer
evidence to demonstrate the inadequacy of the petitioner’s
evidence on a requisite element of the petitioner’s case-in-
chief.”); Pafford v. Sec’y of Health & Human Servs., 451
F.3d 1352, 1358-59 (Fed. Cir. 2006) (“[T]he presence of
multiple potential causative agents makes it difficult to
attribute ‘but for’ causation to the vaccination. . . . [T]he
Special Master properly introduced the presence of the
other unrelated contemporaneous events as just as likely
to have been the triggering event as the vaccinations.”).
Indeed, in some cases a sensible assessment of causation
cannot be made while ignoring the elephant in the room—
the presence of compelling evidence of a different cause
for the injury in question. Walther, 485 F.3d at 1151 n.4
(“Where multiple causes act in concert to cause the injury,
STONE v. HHS 14
proof that a particular vaccine was a substantial cause
may require the petitioner to establish that the other
causes did not overwhelm the causative effect of the
vaccine.”). Therefore, the special master is entitled to
consider the record as a whole in determining causation,
especially in a case involving multiple potential causes
acting in concert, and no evidence should be embargoed
from the special master’s consideration simply because it
is also relevant to another inquiry under the statute. See
Doe v. Sec’y of Health & Human Servs., 601 F.3d 1349,
1356-58 (Fed. Cir. 2010); De Bazan, 539 F.3d at 1353;
Shyface, 165 F.2d at 1352. The two related points that
our cases make clear about “factors unrelated” evidence
is, first, that a special master may not require the peti-
tioner to shoulder the burden of eliminating all possible
alternative causes in order establish a prima facie case,
see Doe, 601 F.3d at 1356-57; Walther, 485 F.3d at 1152,
and second, that a special master may find that a factor
other than a vaccine caused the injury in question only if
that finding is supported by a preponderance of the evi-
dence, Walther, 485 F.3d at 1151.
In both of the cases before us, the special master
found that the government had satisfied its “preponder-
ance” burden under the “factors unrelated” defense. It is
therefore unnecessary for us to address whether the
special master was correct in holding, in the Hammitt
case, that the petitioner failed to make out a prima facie
case of causation.
In pressing their legal theory of causation, the peti-
tioners rely on Sections 442 and 451 of the Second Re-
statement of Torts. Those sections deal with the issue of
when intervening events constitute “superseding causes”
that have the legal effect of breaking the causal connec-
15 STONE v. HHS
tion between a defendant’s tortious act and a plaintiff’s
injury. Section 442 reads as follows:
§ 442. Considerations Important In Determining
Whether An Intervening Force Is A Superseding
Cause
The following considerations are of importance in
determining whether an intervening force is a su-
perseding cause of harm to another:
(a) the fact that its intervention brings about
harm different in kind from that which would oth-
erwise have resulted from the actor's negligence;
(b) the fact that its operation or the consequences
thereof appear after the event to be extraordinary
rather than normal in view of the circumstances
existing at the time of its operation;
(c) the fact that the intervening force is operating
independently of any situation created by the ac-
tor's negligence, or, on the other hand, is or is not
a normal result of such a situation;
(d) the fact that the operation of the intervening
force is due to a third person's act or to his failure
to act;
(e) the fact that the intervening force is due to an
act of a third person which is wrongful toward the
other and as such subjects the third person to li-
ability to him;
(f) the degree of culpability of a wrongful act of a
third person which sets the intervening force in
motion.
STONE v. HHS 16
Section 451 reads as follows:
§ 451. Extraordinary Force Of Nature Intervening
To Bring About Harm Different From That
Threatened By Actor's Negligence
An intervening operation of a force of nature
without which the other's harm would not have
resulted from the actor's negligent conduct pre-
vents the actor from being liable for the harm, if
(a) the operation of the force of nature is extraor-
dinary, and
(b) the harm resulting from it is of a kind different
from that the likelihood of which made the actor's
conduct negligent.
The petitioners argue in both cases that the DTaP
vaccinations caused the children’s injuries and that the
SCN1A gene mutation was not a superseding cause of
their seizure disorders under the Restatement. They
argue that the gene mutation cannot be considered a
superseding cause because in each case the DTaP vacci-
nation and the SCN1A gene mutation acted together to
cause the SMEI and that the gene mutation brought
about harm identical in kind to the harm caused by the
DTaP vaccine—an increased propensity or susceptibility
to seizures.
The problem with that argument is that the petition-
ers assume the special master determined that the
SCN1A gene mutation was a “superseding cause” of the
SMEI. That is not the case, however. To the contrary,
the special master determined in both cases that the
17 STONE v. HHS
SCN1A gene mutation “was the sole, substantial cause,
principally responsible for [the] SMEI.” Hammitt II at 11;
Stone II at 4 (using substantially identical language). The
special master concluded that the DTaP vaccine played no
role whatsoever in either child’s SMEI. Stone I at 48
(“There is simply no evidence that [the] initial seizure
caused any brain damage, or somehow affected the ex-
pression of [the] genetic mutation in such a way that
caused Amelia to develop SMEI or experience further
seizures.”); Hammitt I at 50 (using substantially identical
language). Because the special master determined that
the gene mutation was the sole cause of the children’s
SMEI, he did not engage in a superseding cause analysis,
nor did he need to. The “superseding cause” analysis
presupposes that the first factor was causally related to
the injury; the analysis seeks to determine whether that
causal relationship should be considered to have been
superseded by subsequent events. That analysis has no
role to play where, as here, the initial factor is found to
have no causal relationship to the ultimate injury.
From their legal challenge, the petitioners move to
taking issue with the special master’s factual findings
that the vaccines played no role in causing either child’s
SMEI. They contend that the special master should have
found, as a factual matter, that in both cases the DTaP
vaccine resulted in an increased propensity to have sei-
zures, which made the children more vulnerable to the
onset of the seizure condition associated with their
SCN1A gene mutations. The problem with that argument
is that the special master found that the only harm
caused by the DTaP vaccination in each case was the
single, isolated, initial febrile seizure, which is not by
itself a compensable injury. Hammitt I at 53-54; Stone I
at 52. The special master found that there was “simply
no evidence that [the] initial seizure . . . caused [Amelia or
STONE v. HHS 18
Rachel] to develop SMEI or experience further seizures.”
Hammitt I at 50; Stone I at 48. The seizure disorder, the
special master found, was triggered by the SCN1A gene
mutation alone, and the initial febrile seizures did not
result in any brain injury that caused, triggered, or ren-
dered either child more susceptible to developing SMEI.
E.g., Hammitt II at 11; Stone II at 4.
The petitioners’ factual argument is unpersuasive in
light of the applicable standard of review, which requires
us to uphold the findings of the special master unless they
are arbitrary or capricious. See Porter v. Sec’y of Health
& Human Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011).
The Stones rely on Dr. Kinsbourne’s assertion that Ame-
lia suffered brain damage from the initial febrile seizures.
His testimony to that effect, however, was not based on
any evidence of a clinical manifestation of brain damage
resulting from Amelia’s initial seizure. 2 The respondent’s
experts testified that the medical record contains no
indication of brain damage or any other continuing effect
from Amelia’s initial febrile seizures. The special master
found the respondent’s experts’ testimony on that issue to
be more reliable than Dr. Kinsbourne’s in view of their
more extensive and more recent experience in the fields of
pediatric neurology and genetics. The Stones point to no
clear error of fact committed by the special master, but
simply contend that the special master was wrong to
disregard the possibility that the initial febrile seizure
had an effect on Amelia’s susceptibility to seizures in the
2 In their brief, the Stones argue that an EEG ad-
ministered the day after Amelia’s first seizure showed a
vaccine-caused encephalopathy. The evidence, however,
showed that the treating physicians characterized the
results of the first EEG as “questionable,” and the results
of a second EEG conducted two days later were reported
as normal.
19 STONE v. HHS
future. The special master’s findings on that issue were
based on extensive expert evidence and cannot be re-
garded as arbitrary and capricious.
The Stones argue that the special master should not
have credited Dr. Raymond’s testimony because (1) Dr.
Raymond is not an expert on the SCN1A gene, (2) Ame-
lia’s SCN1A variant is novel and unstudied, (3) Dr. Kins-
bourne’s testimony rebutted Dr. Raymond’s theory, and
(4) Dr. Raymond’s theory employs circular logic. None of
those arguments undermines the special master’s find-
ings that Amelia’s initial febrile seizure did not have
continuing effects and did not contribute to, trigger, or
make her more susceptible to developing SMEI.
The special master found that Dr. Raymond was ex-
tremely well qualified to testify as to the genetic cause of
Amelia’s SMEI. Dr. Raymond is an associate professor in
neurology at Johns Hopkins University and the director of
neurogenetics at the Kennedy Kreiger Institute. Dr.
Raymond's specialty is neurogenetics, and he is board
certified in neurology with a special competence in both
pediatric neurology and clinical genetics. Although the
petitioners contend that Dr. Raymond is not an expert on
the SCN1A gene, the evidence showed that Dr. Raymond
is an expert in neurology and genetics. Accordingly, even
though Amelia’s SCN1A mutation may have been atypi-
cal, Dr. Raymond was qualified to testify about her ge-
netic condition generally and the effect of that mutation
in particular.
We reject the petitioners’ contention that Dr. Ray-
mond’s theory of causation was the product of circular
logic, i.e., that he reasoned backwards from the fact that
Amelia has SMEI to the conclusion that her SNC1A
mutation must have caused it. Dr. Raymond addressed in
STONE v. HHS 20
some detail the reasons he concluded that the SNC1A
gene mutation caused SMEI in both Amelia and Rachel.
He explained that a number of factors cumulatively
demonstrated that the gene mutation was responsible for
both children’s SMEI: (1) the gene mutation was not
inherited but arose de novo, so the absence of SMEI in
either parent was not probative; (2) the mutation resulted
in a non-conservative amino acid change, i.e., the muta-
tion produced a new amino acid having very different
physical properties from the corresponding amino acid
found in normal individuals; (3) the mutation affects a
functionally important region, a portion of the sodium
channel in neurons that is crucial to the normal function-
ing of the nervous system; (4) the mutation occurs in an
area that is well conserved across species, “indicating that
changes here are probably not well tolerated”; (5) there is
an absence of the mutation in the normal population; (6)
medical reports show that a mutation in the same loca-
tion has been associated with SMEI; and (7) between 80
and 90 percent of patients with SMEI have an SCN1A
gene mutation. It was those factors, not circular reason-
ing, that led Dr. Raymond to conclude that the SCN1A
gene mutation was the cause of the SMEI in both chil-
dren.
We also reject the petitioners’ arguments that Dr.
Kinsbourne successfully rebutted Dr. Raymond’s theory
and that the special master’s findings should be rejected
as arbitrary and capricious for that reason. The petition-
ers cite several medical articles that Dr. Kinsbourne
discussed in his testimony and contend that those articles
rebut Dr. Raymond’s theory. The special master ad-
dressed each article and explained why the articles failed
to support Dr. Kinsbourne’s theory.
21 STONE v. HHS
The petitioners note that Dr. Kinsbourne relied on an
article by Dr. Christoph Lossin, in which Dr. Lossin wrote
that he could not predict a child’s clinical condition based
on the child’s SCN1A gene mutation. However, the
special master found that “[p]etitioners simply failed to
develop fully this argument.” Stone I at 34. The special
master also pointed out that Dr. Lossin is not a clinical
geneticist, and that Dr. Raymond’s opinion as a clinical
geneticist is that a correlation can be made between a
child’s clinical condition and the SCN1A gene mutation.
Id. at 34, 38-39. After considering the Lossin article, the
special master credited Dr. Raymond’s determination that
“a reasonable clinical geneticist if presented with this
information that we have in front of us today would come
to the same conclusions that I have.” Id. at 34.
The petitioners also relied on several other articles in
support of the proposition that a child’s clinical condition
cannot be predicted based on the SCN1A gene mutation.
However, the special master found that none of those
articles offered persuasive rebuttal to Dr. Raymond’s
reasoned conclusion that Amelia’s SMEI was caused by
her SCN1A gene mutation. The special master observed
that most of the examples of divergent conditions oc-
curred among family members with the same mutation,
presumptively an inherited variant that, because it is
inherited, does not have devastating effects on the victim.
The evidence showed, however, that Amelia’s mutation
arose de novo and was not inherited, so the evidence from
persons with inherited mutations is not especially rele-
vant. Stone I at 37. The special master further observed
that none of the articles cited by the petitioners discussed
mutations involving the amino acid change that resulted
from Amelia’s mutation, nor did they discuss the particu-
lar mutation in Amelia’s DNA. The special master there-
fore concluded that the petitioners’ examples were “not
STONE v. HHS 22
comparable and thus are not persuasive rebuttal of Dr.
Raymond’s analysis.” Stone I at 38. After reviewing the
literature, the special master concluded that most or all of
it supports Dr. Raymond’s theory, and that “petitioners’
allegation that Dr. Raymond’s analysis is not supported
by the literature or by objective evidence is simply not
accurate.” Id. at 35. The special master added:
In addition, it cannot be overstated that petition-
ers’ rebuttal suffered from the lack of credible ex-
pert testimony. Dr. Kinsbourne simply was not
qualified or able to counter the testimony of Dr.
Raymond. Petitioners thus had to rely upon
cherry-picked snippets from the medical literature
. . . in an effort to undermine Dr. Raymond. That
effort failed.
Id.
In sum, because of Dr. Raymond’s expert testimony
and the considerable evidentiary support for his views in
the record, we cannot conclude that the special master’s
conclusion that the SCN1A gene mutation was solely
responsible for Amelia’s SMEI was arbitrary or capri-
cious.
III
The petitioners next argue that the special master
erred by imposing an inappropriately high burden of proof
on them. Specifically, they argue that the special master
required direct evidence of brain damage and required
them to prove the biological mechanism by which the
vaccines caused the children’s injuries.
The petitioners are correct that in order to prevail in a
vaccine case a petitioner need not provide proof of the
23 STONE v. HHS
specific biological mechanism leading to the injury at
issue. See Knudsen v. Sec’y of Health & Human Servs., 35
F.3d 543, 549 (Fed. Cir. 1994) (“[T]o require identification
and proof of specific biological mechanisms would be
inconsistent with the purpose and nature of the vaccine
compensation program.”). The special master, however,
did not impose such a burden on the petitioners in these
cases. He denied compensation not because the parties
failed to show how the vaccines caused brain damage, but
because they failed to show that the vaccines caused any
brain damage.
As noted above, Dr. Kinsbourne’s theory was that the
vaccines contributed to the children’s SMEI because they
caused fevers, which triggered the initial febrile seizures,
which in turn resulted in a reduced seizure threshold due
to brain damage caused by the initial seizures. A key
component of Dr. Kinsbourne’s theory is that the initial
seizure caused some form of lasting brain injury that had
downstream consequences for both children, specifically a
lowered seizure threshold. Accordingly, the special mas-
ter sought evidence of brain damage resulting from the
initial febrile seizures. However, Dr. Kinsbourne was
unable to identify any evidence that either child had
suffered brain damage as a result of those seizures.
When the special master asked Dr. Kinsbourne if there
was any clinical manifestation of the brain damage to
support his inference of brain damage, Dr. Kinsbourne
responded that there was not. The respondent’s experts
also testified that the records indicated that neither child
suffered brain damage as a result of their initial seizures.
With respect to both Amelia and Rachel, the special
master concluded that “[t]here is simply no evidence that
[the] initial seizure caused any brain damage, or somehow
affected the expression of [the] genetic mutation in such a
way that caused [each child] to develop SMEI or experi-
STONE v. HHS 24
ence further seizures.” Stone I at 48; Hammitt I at 50.
Thus, the special master did not insist on evidence of the
biological mechanism by which the brain damage was
caused. He merely sought evidence of the existence of
brain damage—a key component of Dr. Kinsbourne’s
theory—and Dr. Kinsbourne was unable to provide any.
In support of their claim that the special master re-
quired evidence of the biological mechanism by which the
vaccines caused brain damage, the Stones point to the
following statement in the special master’s first opinion:
“As discussed, Dr. Kinsbourne and petitioners failed to
demonstrate how Amelia’s vaccination or her fever result-
ing from her vaccination altered the course of her geneti-
cally based seizure disorder.” Stone I at 49. Mr. Hammitt
points to the following statement, also from the special
master’s first opinion: “Nor is there any cogent explana-
tion for how an environmental trigger, specifically a
vaccine, significantly contributed to Rachel’s SMEI.”
Hammitt I at 51. In context, however, it is clear that
those statements do not indicate that the special master
required the petitioners to prove the biological mechanism
of the injury. The quoted statements were made in the
course of the special master’s discussion of whether there
was any clinical evidence of brain damage, not as a com-
mentary on the absence of any explanation of the mecha-
nism by which the injury may have occurred. It is clear in
context that the special master sought evidence that brain
damage existed, not how it was caused.
Finally, we reject the petitioners’ argument that the
special master improperly disregarded Dr. Kinsbourne’s
evidence of brain damage because that evidence was
circumstantial rather than direct. The special master did
not reject the petitioners’ evidence of brain damage on the
ground that it was circumstantial; rather, he found that
25 STONE v. HHS
Dr. Kinsbourne’s inference of brain damage, in the face of
clinical records showing no brain damage, was unpersua-
sive and that it was therefore insufficient to carry the
petitioners’ burden on causation.
IV
The final issue is unique to Mr. Hammitt. After the
special master’s initial decision in the Hammitt case,
which the Court of Federal Claims remanded to the
special master for application of the correct standard of
proof, Mr. Hammitt moved to submit additional evidence
in the form of a medical journal article, a comment on the
article, and a supplemental report from Dr. Kinsbourne.
The special master denied the motion. Mr. Hammitt
argues that the special master’s refusal to supplement the
record was an abuse of discretion.
The special master gave several reasons for denying
Mr. Hammitt’s motion. First, he noted that the case had
been remanded for further explanation of the standard of
proof, and, more specifically, to address whether the
petitioner had presented a prima facie case for compensa-
tion and whether the burden of proof had shifted to the
respondent. The case was not remanded for further
factual development.
Second, the special master found that the petitioner’s
expert, Dr. Kinsbourne, was “aware of the article and its
significance” well before the special master issued his
initial opinion in the case. For that reason, the special
master explained, the petitioner “had ample opportunity
to move for its consideration.”
Third, the special master reviewed the new article
and concluded that it “does not appear to support peti-
STONE v. HHS 26
tioner’s case.” The respondent filed a response to the
article, in which Dr. Raymond disputed Dr. Kinsbourne’s
representations regarding the article and concluded that
“[t]here is no evidence that has been submitted to date
that any of the variability in outcomes is due to any
vaccination received.” Full consideration of the submitted
information would require further expert testimony, the
special master concluded, which likely could not be com-
pleted within the remand period.
The petitioner relies on Vant Erve v. Secretary of
Health & Human Services, 39 Fed. Cl. 607 (1997), in
support of his position that the special master abused his
discretion in declining to supplement the record. In Vant
Erve, the case was still pending before the special master
in the damages phase when the respondent moved to
reopen the record. Id. at 610. The Court of Federal
Claims found that the special master abused his discre-
tion when he denied respondent’s motion, and the court
therefore remanded the case to the special master, who
ultimately reversed his previous decision on the merits
based on the new evidence.
Vant Erve is not helpful to the petitioner. Here, the
petitioner waited until after he had appealed the special
master’s entitlement decision and the case had been
remanded on a legal issue before attempting to submit
the evidence. The remand order did not contemplate the
submission of new evidence, and the special master found
that the “new” evidence was known and available to the
petitioner prior to the special master’s initial decision and
could have been submitted in a timely fashion. Moreover,
because it was not clear that the article would have
strengthened the petitioner’s case or affected the special
master’s decision, the petitioner has not shown that he
was prejudiced by the special master’s denial of the
27 STONE v. HHS
motion. The special master therefore did not abuse his
discretion by denying the petitioner’s motion.
Accordingly, we affirm the judgments in both cases
before us.
AFFIRMED