Oliver v. Hhs , 900 F.3d 1357 ( 2018 )

United States Court of Appeals
for the Federal Circuit
______________________
LAURA OLIVER AND EDDIE OLIVER, JR.,
PARENTS AND LEGAL REPRESENTATIVES OF
E.O., III,
Petitioners-Appellants
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2017-2540
______________________
Appeal from the United States Court of Federal
Claims in No. 1:10-vv-00394-EDK, Judge Elaine Kaplan.
______________________
Decided: August 17, 2018
______________________
CLIFFORD JOHN SHOEMAKER, Shoemaker and Associ-
ates, Vienna, VA, argued for petitioners-appellants.
DANIEL ANTHONY PRINCIPATO, Torts Branch, Civil
Division, United States Department of Justice, Washing-
ton, DC, argued for respondent-appellee. Also represent-
ed by CHAD A. READLER, C. SALVATORE D’ALESSIO,
CATHARINE E. REEVES, HEATHER LYNN PEARLMAN.
______________________
2 OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS.
Before NEWMAN, LOURIE, and WALLACH, Circuit Judges.
Opinion for the court filed by Circuit Judge WALLACH.
Dissenting opinion filed by Circuit Judge NEWMAN.
WALLACH, Circuit Judge.
Appellants Laura Oliver and Eddie Oliver, Jr. (to-
gether, “the Olivers”), parents and legal representatives of
E.O., III (“E.O.”), sued the Secretary of Health and Hu-
man Services (“the Government”) for compensation under
the National Childhood Vaccine Injury Act of 1986 (“Vac-
cine Act”), Pub. L. No. 99-660, 100 Stat. 3755 (codified as
amended at 42 U.S.C. §§ 300aa-2–300aa-33 (2012)). The
Olivers allege that E.O. developed Dravet syndrome 1 as a
result of certain vaccinations. The Chief Special Master
of the U.S. Court of Federal Claims determined that, inter
alia, the Olivers “failed to show by preponderant evidence
that E.O.’s injuries were caused by his . . . vaccinations,”
such that the Olivers were not entitled to compensation.
Oliver v. Sec’y of Health & Human Servs. (Oliver I), No.
10-394V, 2017 WL 747846, at *2 (Fed. Cl. Feb. 1, 2017).
The Olivers filed a motion for review in the Court of
Federal Claims, and the Court of Federal Claims denied
it. See Oliver v. Sec’y of Health & Human Servs. (Oliver
II), 133 Fed. Cl. 341, 344 (2017); see also J.A. 52 (Judg-
ment).
1 According to a 2010 study on the relation between
vaccination and Dravet syndrome, “Dravet syndrome,
formerly severe myoclonic epilepsy of infancy (SMEI), is
characterized by prolonged febrile seizures starting at
about the age of [six] months.” J.A. 1221. “Mutations in
[the] SCN1A [gene] can be identified in the majority of
patients, and epileptic seizures in the setting of fever are
a clinical hallmark” of Dravet syndrome. J.A. 1221 (ital-
ics omitted).
OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS. 3
The Olivers appeal. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(3) (2012). We affirm.
BACKGROUND 2
On April 9, 2009, E.O. visited a pediatrician for his
six-month visit and received vaccinations for Diphtheria-
Tetanus-acellular Pertussis, Hepatitis B, Inactivated
Poliovirus, Pneumococcal Conjugate, and Rotavirus.
Oliver I, 2017 WL 747846, at *4. At approximately 11:30
PM that night, Mrs. Oliver “found E.O. seizing in his bed”
and called 9-1-1. Id. (citation omitted). When he arrived
at the emergency room, E.O. presented with “a fever of
101.3 degrees, red eyes with discharge from his right eye,
and a runny nose.” Id. (internal quotation marks and
citation omitted). The emergency room physician diag-
nosed E.O. with a febrile seizure and discharged E.O.
with instructions to see his pediatrician. Id. On April 10,
2009, E.O.’s pediatrician recorded E.O.’s temperature as
97.1 degrees and diagnosed E.O. with “complex febrile
seizure and conjunctivitis in the right eye.” Id. (citation
omitted).
“E.O. did not have any health issues or seizures for
the next two months.” Id. However, E.O. had several
seizures over the summer of 2009 and began to experience
prolonged seizures in March 2010, with each seizure
resulting in an emergency room visit. Id. at *5. In April
2010, E.O. was referred to a pediatric neurologist, who
diagnosed E.O. with an SCN1A gene defect in June 2010.
Id. at *5–6. In July 2010, E.O. began to exhibit develop-
2 The relevant facts and procedural history are
largely undisputed and are set forth in the Chief Special
Master’s and Court of Federal Claims’ decisions below.
See Oliver II, 133 Fed. Cl. at 344–48; Oliver I, 2017 WL
747846, at *1–9. For convenience, we cite those opinions
in outlining the undisputed facts relevant to this appeal.
4 OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS.
mental delay, and the pediatric neurologist performed
general physical, neurological, and motor examinations,
which demonstrated “intractable, symptomatic childhood
absence and complex partial seizures of independent
hemisphere origin secondary to SCN1A gene defect (bor-
derline SMEI syndrome) and encephalopathy character-
ized by speech delay.” Id. at *6 (internal quotation marks
and citation omitted).
DISCUSSION
I. Standard of Review and Legal Standard
“We review an appeal from the Court of Federal
Claims in a Vaccine Act case de novo, applying the same
standard of review [as the Court of Federal Claims]
applied in reviewing the special master’s decision.” Milik
v. Sec’y of Health & Human Servs., 822 F.3d 1367, 1375
(Fed. Cir. 2016) (citation omitted). “Although we review
legal determinations without deference, we review the
special master’s factual findings under the arbitrary and
capricious standard.” Id. at 1376 (citation omitted). This
standard is “uniquely deferential” and “difficult for an
appellant to satisfy with respect to any issue, but particu-
larly with respect to an issue that turns on the weighing
of evidence by the trier of fact.” Id. (internal quotation
marks and citations omitted). “[A]s long as the special
master’s conclusion is based on evidence in the record
that is not wholly implausible, we are compelled to uphold
that finding as not being arbitrary or capricious.” Id.
(internal quotation marks, brackets, and citation omit-
ted).
Where, as here, a petitioner alleges an injury not
found on the Vaccine Injury Table (“the Table”), 3 they
3 The Table is published in 42 U.S.C. § 300aa-14.
For injuries listed in the Table, i.e., “Table Injuries,”
“causation is presumed when a designated condition
OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS. 5
“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.” Moberly, 592 F.3d at 1321 (internal
quotation marks and citation omitted). To demonstrate
causation, the petitioner’s “burden is to show by prepon-
derant evidence” each of the requirements set forth in
Althen v. Secretary of Health and Human Services (“the
Althen prongs”): “(1) a medical theory causally connecting
the vaccination and the injury; (2) a logical sequence of
cause and effect showing that the vaccination was the
reason for the injury; and (3) a showing of a proximate
temporal relationship between vaccination and injury.”
418 F.3d 1274, 1278 (Fed. Cir. 2005). “If [the petitioner]
satisfies this burden, she is entitled to recover unless the
[G]overnment shows, also by a preponderance of evidence,
that the injury was in fact caused by factors unrelated to
the vaccine.” Id. (internal quotation marks, brackets, and
citation omitted).
II. The Court of Federal Claims Did Not Err in Sustaining
the Chief Special Master’s Determination
The Chief Special Master determined that the Olivers
failed to satisfy their burden as to each of the Althen
prongs. Oliver I, 2017 WL 747846, at *11–21. The Oli-
vers aver that the Chief Special Master erred in her
evaluation of the Althen prongs by: (1) “misappl[ying]
Daubert [v. Merrell Dow Pharmaceuticals, Inc., 509 U.S.
579 (1993)] and thus appl[ying] an evidentiary standard
not in accordance with law,” Appellants’ Br. 17 (capitali-
follows the administration of a designated vaccine within
a designated period of time.” Moberly ex rel. Moberly v.
Sec’y of Health & Human Servs., 592 F.3d 1315, 1321
(Fed. Cir. 2010). For “all other injuries alleged to be
caused by a vaccine” that are not listed in the Table, i.e.,
“off-Table injuries,” “causation must be proved in each
case.” Id. (citation omitted).
6 OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS.
zation modified); see id. at 17–33; and (2) “improperly
using estoppel and a faulty scientific premise to deny both
a full and fair hearing, in an abuse of her discretion, as
well as a finding of causation,” id. at 34 (italics omitted);
see id. at 34–43. We disagree with the Olivers.
First, although the Olivers claim that the Chief Spe-
cial Master misapplied Daubert, their argument amounts
to no more than a challenge to the weight afforded to their
expert’s testimony and supporting evidence. 4 See id. at
17–33. The Chief Special Master thoroughly evaluated
both parties’ evidence as to each Althen prong and found
the Government’s more persuasive. See Oliver I, 2017 WL
747846, at *11–21. For example, regarding the first
Althen prong, the Chief Special Master found that “none
of the articles cited by [the Olivers’ expert] suggest that
vaccines can cause . . . or change the clinical course of
Dravet syndrome, and several come to the opposite con-
clusion,” whereas the Government’s expert “provide[d]
strong evidence [in the form of animal studies] that
Dravet syndrome will develop in children with the
SCN[1]A mutation, whether or not they receive vaccina-
tions.” Id. at *16; see id. at *11–16 (reviewing the parties’
4 While the Chief Special Master referenced Daub-
ert in the “Standards for Adjudication” section of her
opinion, see Oliver I, 2017 WL 747846, at *10, she did not
exclude either parties’ evidence and made no reference to
Daubert when weighing the parties’ evidence to determine
whether the Olivers had satisfied their burden of estab-
lishing each of the Althen prongs, see id. at *11–21.
Nevertheless, the Government acknowledges that the
Chief Special Master implicitly conducted a Daubert
analysis in finding the Olivers’ expert’s testimony and
supporting evidence unpersuasive. See Oral Arg. at
18:39–19:17, http://oralarguments.cafc.uscourts.gov/
default.aspx?fl=2017-2540.mp3.
OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS. 7
evidence as to the first Althen prong). In light of these
findings, the Chief Special Master determined that the
Olivers’ expert “did not provide a ‘sound and reliable’
medical theory to explain how the vaccinations at issue
cause Dravet syndrome.” Id. at *16. The Chief Special
Master made similar findings with respect to the second
and third Althen prongs. See id. at *16–20 (reviewing the
parties’ evidence as to the second Althen prong), *20
(finding, with respect to the second Althen prong, that the
Olivers’ expert’s testimony was “not persuasive” in light of
the Government’s expert’s testimony and E.O.’s medical
records, such that the Olivers “failed to prove by a pre-
ponderance of the evidence a logical sequence of cause and
effect showing that the vaccines E.O. received caused his
Dravet syndrome”), *20–21 (reviewing the parties’ evi-
dence as to the third Althen prong), *21 (finding, with
respect to the third Althen prong, that, “[w]hile the prox-
imity between vaccination and seizure onset might sug-
gest a causal relationship between the two events, E.O.
did not develop Dravet syndrome until . . . more than a
year after these vaccinations,” such that the Olivers’
evidence “[wa]s not sufficient to establish a causal link”).
The Olivers repeatedly fault the Chief Special Master
for failing to afford greater weight to their expert’s testi-
mony and supporting evidence. See, e.g., Appellants’
Br. 25 (stating that “the [Chief] Special Master is highly
dismissive of all of [their expert]’s testimony”), 26 (stating
that the Olivers’ expert’s “theory and . . . mechanisms
were, in fact, supported by the literature even if his con-
clusions were not yet published”), 33 (stating that the
Chief Special Master “essentially reject[ed]” their expert’s
supporting evidence). We cannot review such challenges.
See Milik, 822 F.3d at 1376 (“[W]e do not reweigh the
factual evidence, assess whether the special master
correctly evaluated the evidence, or examine the probative
value of the evidence or the credibility of the witnesses—
these are all matters within the purview of the fact find-
8 OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS.
er.” (internal quotation marks and citation omitted));
Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357,
1362 (Fed. Cir. 2000) (stating that “assessments of the
credibility of the witnesses and the relative persuasive-
ness of the competing medical theories of the case” “are
virtually unchallengeable on appeal”). Therefore, we hold
that the Chief Special Master did not misapply Daubert in
weighing the parties’ experts’ testimony and supporting
evidence and that the Chief Special Master’s factual
findings were neither arbitrary nor capricious. See de
Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347,
1352 n.4 (Fed. Cir. 2008) (rejecting similar arguments on
the grounds that “Daubert is inapposite here because the
special master did not exclude any expert evidence under
Daubert” and, instead, “admitted and weighed both par-
ties’ evidence but simply decided that the [G]overnment’s
evidence was more persuasive”); Terran ex rel. Terran v.
Sec’y of Health & Human Servs., 195 F.3d 1302, 1316
(Fed. Cir. 1999) (affirming a “[s]pecial [m]aster’s analy-
sis . . . using Daubert[] . . . as a tool or framework for
conducting the inquiry into the reliability of the evidence,”
where the special master’s “application of the Daubert
factors [was] reasonable,” because “[t]he [s]pecial [m]aster
found that the Daubert inquiry raised serious questions
about the [petitioner’s expert’s] testimony,” such that “the
proffered theory of causation was not sufficiently relia-
ble”). 5
5 At oral argument, the Olivers asked the court to
take judicial notice of an extra-record scientific article
published in 2017 (“the 2017 Article”). Oral Arg. at
10:12–11:41; see Reply Br. 20 & n.8 (discussing Valentina
Cetica et al., Clinical and Genetic Factors Predicting
Dravet Syndrome in Infants with SCN1A Mutations,
88(11) Neurology 1037, 1037 (2017), available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5384833/
OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS. 9
(exploring the “prognostic value of initial clinical and
mutational findings in infants with SCN1A mutations”
and concluding that, “[i]n individuals with SCN1A muta-
tions, age at seizure onset appears to predict outcome
better than mutation type” (italics omitted)). The Olivers
allege that this article demonstrates that one “can have
the SCN1A [gene] and not develop Dravet syndrome” and
that E.O.’s “vaccination triggered the onset of seizures
within his first [twelve] months” and, thus, was a but-for
cause of his injuries because it “did impact his clinical
course.” Reply Br. 21.
Scientific “theories that are so firmly established as to
have attained the status of scientific law, such as the laws
of thermodynamics, properly are subject to judicial notice
under Federal Rule of Evidence 201.” Daubert, 509 U.S.
at 592 n.11; see Fed. R. Evid. 201(b) (“The court may
judicially notice a fact that is not subject to reasonable
dispute because it: (1) is generally known within the trial
court’s territorial jurisdiction; or (2) can be accurately and
readily determined from sources whose accuracy cannot
reasonably be questioned.”). However, the Olivers have
failed to establish that this theory has garnered such
widespread acceptance, as evidenced by the Chief Special
Master’s extensive discussion of articles with contradicto-
ry findings. See, e.g., Oliver I, 2017 WL 747846, at *15
(discussing “studies show[ing] that the occurrence of
febrile seizures following vaccinations does not change the
clinical course or outcome of Dravet syndrome”). There-
fore, we decline to take judicial notice of the 2017 Article.
See Brown v. Piper, 91 U.S. 37, 42–43 (1875) (explaining
that a courts’ power to take judicial notice “is to be exer-
cised . . . with caution,” that “[c]are must be taken that
the requisite notoriety exists,” and that “[e]very reasona-
ble doubt upon the subject should be resolved promptly in
the negative”). To the extent the Olivers ask us to consid-
er findings in the 2017 Article, “studies that were not
10 OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS.
Second, the Chief Special Master did not apply estop-
pel to either deny a fair hearing or bar the Olivers’ theory
of causation. The Olivers assert that the Chief Special
Master “effectively estopped the [Olivers] from fully
presenting [their] case,” Appellants’ Br. 39, by noting
that, “[t]o date, there have been at least [fifteen] oth-
er . . . cases which involved children with SCN1A muta-
tions[] and compensation has been denied in all of these
cases,” Oliver I, 2017 WL 747846, at *1 (footnote omitted);
see id. at *1 n.3 (listing the prior cases); see also Estoppel,
Black’s Law Dictionary (10th ed. 2014) (defining estoppel
as, inter alia, “[a] bar that prevents the relitigation of
issues”). However, one reference to other cases rejecting
similar claims does not constitute the application of
estoppel. Cf. Waymo LLC v. Uber Techs., Inc., 870 F.3d
1350, 1361 (Fed. Cir. 2017) (“We will not find legal error
based upon an isolated statement stripped from its con-
text.” (internal quotation marks and citation omitted)).
Indeed, the Chief Special Master made no reference to
estoppel, see generally Oliver I, 2017 WL 747846, and the
Olivers concede that they cannot identify where the Chief
Special Master applied estoppel to bar their claims, see
Oral Arg. at 2:04–41 (acknowledging that the Chief Spe-
cial Master’s opinion did not apply equitable estoppel and
failing to identify any authority for finding an improper
application of equitable estoppel under those circum-
stances). As we explained above, the Chief Special Mas-
ter thoroughly considered the parties’ evidence and found
the Government’s more persuasive, Oliver I, 2017 WL
before the [Chief S]pecial [M]aster are not appropriate for
consideration on appellate review.” Whitecotton ex rel.
Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d
1099, 1104–05 (Fed. Cir. 1996) (citation omitted).
OLIVER v. SEC’Y OF HEALTH & HUMAN SERVS. 11
747846, at *11–27, and we may not reweigh that evidence
on appeal, see Milik, 822 F.3d at 1376. 6
CONCLUSION
We have considered the Olivers’ remaining arguments
and find them unpersuasive. Accordingly, the Judgment
of the U.S. Court of Federal Claims is
AFFIRMED
6 To the extent the Olivers contend that, even if the
Chief Special Master did not improperly apply estoppel,
the Chief Special Master abused her discretion by denying
their request for an evidentiary hearing, see Appellants’
Br. 39, we disagree. Special masters have “wide discre-
tion” to determine whether to hold an evidentiary hear-
ing. Burns ex rel. Burns v. Sec’y of Dep’t of Health &
Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993); see 42
U.S.C. § 300aa-12(d)(3)(B)(v) (providing that the special
master “may conduct such hearings as may be reasonable
and necessary”); Rule 8(d) of App. B to the Rules of the
Court of Federal Claims (permitting the special master to
“decide a case on the basis of written submissions without
conducting an evidentiary hearing”). Because the record
was fully developed and the Olivers have not identified
any factual or legal errors by the Chief Special Master
that would have necessitated an evidentiary hearing, we
conclude that the Chief Special Master acted within her
discretion in denying the Olivers’ request for such a
hearing. See Burns, 3 F.3d at 417.
United States Court of Appeals
for the Federal Circuit
______________________
LAURA OLIVER AND EDDIE OLIVER, JR.,
PARENTS AND LEGAL REPRESENTATIVES OF
E.O., III,
Petitioners-Appellants
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee
______________________
2017-2540
______________________
Appeal from the United States Court of Federal
Claims in No. 1:10-vv-00394-EDK, Judge Elaine Kaplan.
______________________
NEWMAN, Circuit Judge, dissenting.
Infant E.O. was described by his pediatrician, at his
6-month well-baby visit on April 9, 2009, as developing
normally, temperature 97.4º F. He was given the third
dose of the DTaP 1 vaccine. At about 11:30 that night he
was found convulsing and with a fever. He was rushed by
ambulance to the emergency room, where a temperature
of 101.3º F was recorded. By August 2009 E.O. had six
observed seizure episodes. By the following year seizures
1 Diptheria-Tetanus-acellular Pertussis. J.A. 2.
2 OLIVER v. HHS
were occurring daily, and normal mental and physical
development were affected.
E.O.’s parents obtained genetic analysis of both his
and their DNA. E.O. was found to have a mutation of the
SCN1A gene, which has become associated with “severe
myoclonic epilepsy in infancy,” also called “Dravet syn-
drome,” as characterized by Dr. Dravet in 1978. 2 The
Petitioners duly sought the benefits of the Vaccine Act,
but the Special Master held that since E.O. has this
genetic mutation, any vaccine relationship is irrelevant
and the Vaccine Act does not apply. My colleagues now
affirm this ruling.
I respectfully dissent, for this is a classic case of vac-
cine injury, within the purpose, policy, and text of the
Vaccine Act. Advances in scientific understanding of why
some infants experience vaccine-related seizures and
their tragic consequences, support the statutory plan.
DISCUSSION
It was known that about one half of one percent of ap-
parently normal infants experience a serious adverse
reaction to vaccine. See S. Hrg. 98-1060, at 21 (1984).
Vaccine injury of healthy infants has long been believed to
be affected by some aberration within the infant; advanc-
es in genetic science now are enabling exploration of such
aspects.
The Special Master held that E.O.’s “destiny” is to be
mentally and physically disabled because of his SCN1A
gene mutation. The Special Master held that it is irrele-
vant that E.O. experienced a classic Vaccine Act injury,
and irrelevant whether the vaccine triggered or contribut-
ed to his ensuing disability. The Special Master discarded
2 The record states that E.O.’s parents do not have
the mutation.
OLIVER v. HHS 3
the studies that show at least half of the persons found to
have the SCN1A mutation never manifest Dravet syn-
drome. The Special Master deemed it irrelevant that 20–
30% of persons afflicted with Dravet syndrome do not
have the SCN1A mutation.
The reported studies found that vaccination within
the first 6 months of infancy almost always produced
seizures and led to Dravet syndrome for infants having
the SCN1A mutation, while vaccination after 12 months
never produced seizures and Dravet syndrome. The
studies show that both vaccination and the mutation have
a role in Dravet syndrome. Nonetheless, my colleagues
hold that if a genetic relationship to the injury can be
found, the triggering role of vaccination is irrelevant.
Science is at last providing answers to why some in-
fants manifest a severe reaction to vaccination. However,
these are the infants for whom the Vaccine Act was
enacted. Instead, HHS and the courts now exclude these
infants from the Vaccine Act—in contravention of the
statute and the legislative purpose. 3
3 Congress recognized the consequences of govern-
ment-mandated vaccination when it instituted a compen-
sation scheme. See S. Hrg. 98-1060, at 5 (1984) (“In all of
our States, vaccination is required before a child will be
allowed to enter public school. Federal, State, and local
government officials urge all parents to immunize their
children. For all practical purposes, immunization pro-
grams have become obligatory. Should a child sustain
injury as a consequence of such an immunization pro-
gram, it hardly seems fair that that child or its parents
should sustain the entire burden of the consequences
which may follow.”). Congress was also well aware that
the DTP vaccine could cause the injuries sustained by
E.O. See S. Hrg. 98-350, at 1 (1983) (“The occurrence of
4 OLIVER v. HHS
THE EVOLVING SCIENCE OF VACCINE INJURY
HHS acknowledges that E.O.’s 6-month DTaP vac-
cination produced an immediate reaction of seizures and
fever, squarely within the statutory vaccine injury. 4
However, HHS insists that vaccine injury is irrelevant if
the SCN1A mutation is present.
The Petitioners cite several scientific articles that re-
port studies of the role of vaccination when the SCN1A
mutation is present. These articles illustrate evolving
understanding, drawing on the capabilities of DNA analy-
sis. I have placed these publications in chronological
order, for they illustrate the growth of this area of scien-
tific knowledge, as well as the continuing uncertainties.
1.
M. Nieto-Barrera et al., Severe Myoclonic Epilepsy in
Infancy. An Analytical Epidemiological Study, 30
REV. NEUROL. 620–24 (2000).
The authors report their study of patients afflicted in
infancy with Severe Myoclonic Epilepsy (SMEI, referred
to as “Dravet’s syndrome” by the early 2000s). The article
recites the history of vaccine-related convulsions, and
traces the appearance and effects of infant myoclonic
epilepsy. The authors state:
Our study emphasizes, however, the high fre-
quency in which the first convulsion is related
with the DTP vaccination (six times with the first
occasional central nervous system reactions to pertussis
vaccines is well-established, ranging from simple, short-
lived convulsions to encephalopathy with permanent
brain damage and, rarely, death.”).
4 The Vaccine Act establishes a presumption of vac-
cine injury when fever and seizure occur within 3 days
after immunization, 42 U.S.C. §§ 300aa-14(a); 14(b)(2).
OLIVER v. HHS 5
dose, eight with the second and two with the
third), [a] fact that we consider, with discrete res-
ervations, something more than a coincidence.
The relation between the vaccine DTP and the
convulsions has been discussed extensively. It is
considered by some as mere coincidence etárea, is
estimated that the majority of the seizures that
follow to the pertussis vaccination are associated
with the fever . . . .
J.A. 1197 (internal citations omitted). The authors state
that “[a] relative increase has been verified of the inci-
dence of convulsions in the three first days that follow to
the vaccination,” id., and that “[w]ith independence of the
differences among vaccines of the diverse manufacturers .
. . sufficient experimental data exist to imply to the endo-
toxin and to the germ pertussis in the neurological ad-
verse reactions to the pertussis vaccination.” Id.
2.
Charlotte Dravet et al., Severe myoclonic epilepsy in
infancy (Dravet Syndrome), in Epileptic Syndromes
in Infancy, Childhood and Adolescence 89–113 (J.
Roger et al. eds., 4th ed. 2005).
The authors review the scientific literature and de-
scribe “Dravet syndrome.” They note that some studies
have concluded that “in a significant number of SME
cases a genetic aetiology is likely . . . .” Id. at 90. The
authors report that many studies confirm that the syn-
drome does not manifest exclusively in individuals with
the SCN1A mutation. Id. at 108. The authors discuss
their attempts to understand the biophysical properties of
SCN1A gene mutations and find phenotype/genotype
correlations, and state that the relationship between
genotype and phenotype is “complex.” Id. at 91. The
authors state that:
6 OLIVER v. HHS
afebrile seizures usually occur in the context of a
vaccination or of an infectious episode, or after a
bath. Later on, they are associated with febrile
seizures in 80 per cent of the patients. Nieto-
Barrera et al. (2000) emphasized the coincidence
between the first seizure and the DTP (diphthe-
ria-tetanus-polio) vaccination.
Id. at 92.
3.
Samuel F. Berkovic et al., De-novo mutations of the
sodium channel gene SCN1A in alleged vaccine
encephalopathy: a retrospective study, 5 LANCET
NEUROL. 488–92 (2006).
The authors state that “[v]accination, particularly for
pertussis, has been implicated as a direct cause of an
encephalopathy with refractory seizures and intellectual
impairment.” Id. at 488 (Summary). They trace the
association with SCN1A mutations, and state that “[t]he
mechanism by which SCN1A mutations cause SMEI is
unknown.” Id. at 491. The authors state that some
patients with the SCN1A mutation may develop the
syndrome without a vaccine trigger, and also state:
In the presence of SCN1A mutations, vaccination
can still be argued to be a trigger for the encepha-
lopathy, perhaps via fever or an immune mecha-
nism.
Id. The authors state that this study was not designed to
address that question.
4.
Anne M. McIntosh et al., Effects of vaccination on
onset and outcome of Dravet syndrome: a retrospec-
tive study, 9 LANCET NEUROL. 592–98 (2010).
OLIVER v. HHS 7
The authors, reviewing the scientific literature, state
that about 70–80% of children with Dravet syndrome
have the SCN1A gene mutation, and about 20–30% do not
have the mutation. Id. at 592. They report that about
one-third of children with Dravet syndrome exhibited
onset in less than 3 days after vaccination. The authors
state that “[v]accination might trigger earlier onset of
Dravet syndrome in children who, because of an SCN1A
mutation, are destined to develop the disease.” Id. at 592.
5.
Blanca Tro-Baumann et al., A retrospective study of
the relation between vaccination and occurrence of
seizures in Dravet syndrome, 52(1) EPILEPSIA 175–78
(2011).
The authors state that for infants with SCN1A muta-
tions,
epileptic seizures in the setting of fever are a clin-
ical hallmark. Fever is also commonly seen after
vaccinations and provocation of epileptic seizures
by vaccinations in patients with Dravet syndrome
has been reported, but not systematically as-
sessed.
Id. at 175 (Summary). They report that “[t]he majority of
seizures occurred after DPT vaccinations and within 72 h
after vaccination.” Id.
The authors state that seizures after vaccination are
“a common feature in Dravet syndrome and emphasize
the need for preventive measures for seizures triggered by
vaccination or fever in these children.” Id. at 175.
6.
Meral Özmen et al., Severe myoclonic epilepsy of
infancy (Dravet syndrome): Clinical and genetic
8 OLIVER v. HHS
features of nine Turkish patients, 14(3) ANNALS OF
INDIAN ACADEMY OF NEUROLOGY 178 (2011).
The authors studied patients having the SCN1A mu-
tation, and discuss the complexities of the relation to
vaccines. They summarize past studies, and state:
Sudden occurrence of seizures and developmental
regression after the pertussis vaccine in previous-
ly healthy children may confound as that it may
be related with vaccination. There are several
reasons for seizures and developmental regression
in infancy. Some of them were incorrectly identi-
fied as vaccine encephalopathies. However, later
studies did not support the link between perma-
nent brain damage and vaccines. On the other
hand, similarities were observed between clinical
progressions of SMEI and vaccine encephalopathy
as more data was gained about special epilepsy
syndromes like SMEI. Berkovic et al. detected
SCN1A gene mutations in 11 out of 14 patients
who were diagnosed with vaccine encephalopathy.
It was reported that the cause of vaccine encepha-
lopathy was not vaccination but rather the genet-
ically determined age-specific epileptic
encephalopathy. In our patients, convulsions
started after whole cell pertussis vaccination.
Similarly, recent data from a study by McIntosh
et al. showed that 37 patients out of 40 in the co-
hort had their first seizure after at least one DTP
vaccination. They concluded that while the per-
tussis vaccine is a trigger for earlier onset of the
disease, it does not affect its outcome.
J.A. 1310 (internal citations omitted). The authors con-
clude that:
Pertussis vaccination acts as a trigger for the on-
set of [SMEI]. Neuro-developmental delay and
behavioral problems that appear after two years
OLIVER v. HHS 9
of age should be expected in all patients as long-
term complications of the disease.
J.A. 1311.
7.
Nelia Zamponi et al., Vaccination and Occurrence of
Seizures in SCN1A Mutation–positive Patients: A
Multicenter Italian Study, PEDIATRIC NEUROLOGY
xxx 1–5 (2013).
The authors acknowledge the controversy concerning
the relation of vaccination to Dravet syndrome (“DS”), and
consider whether vaccination should be withheld for
infants with the SCN1A mutation. They state:
The relationship between vaccination and clinical
evolution of SCN1A-mutated patients is still con-
troversial. Moreover, the possible advantage to
suspend vaccination route in these patients has
not been addressed. Recently, some authors have
argued that vaccination might trigger the onset of
DS in patients carrying a genetic mutation be-
cause these patients are genetically inclined to
developing the disease. However, according to
these studies, vaccination does not seem to affect
clinical outcome of DS and therefore it should not
be withheld. In contrast, other authors have stat-
ed that vaccination, performed either before or af-
ter DS onset, might affect clinical outcome of
these patients.
Id. at 2 (internal citations omitted). The authors are
cautious about extrapolating vaccination recommenda-
tions from their results, although they state that “patients
who experienced seizures close to vaccination had an
earlier seizure onset and a higher frequency of status
epilepticus during development.” Id. at 4.
10 OLIVER v. HHS
8.
Valentina Cetica et al., Clinical and Genetic Factors
Predicting Dravet Syndrome in Infants with SCN1A
Mutations, 88(11) NEUROLOGY 1037 (2017).
This is a study of 200 persons having the SCN1A mu-
tation, wherein 97 had Dravet syndrome, including bor-
derline forms, and 103 did not have the syndrome. All
200 subjects were more than 24 months of age, which is
when Dravet syndrome can usually be diagnosed; the
sample had an average age of 18.58 years.
Of these subjects, the relation of seizure occurrence to
Dravet syndrome was analyzed, with 182 patients having
had seizures as their presenting symptom. The authors
report that “age at first seizure and frameshift mutations
were associated with Dravet Syndrome. The risk of
[developing] Dravet Syndrome was 85% [if the first sei-
zure occurred] in the 0- to 6-month group, 51% in the 6- to
12-month range, and 0% after the 12th month.” Id. at
1037. The authors report that: “None of the patients who
experienced their first seizure after 12 months of age
developed Dravet syndrome.” Id. at 1040. Thus, “an
older age at seizure onset represents a protective factor
against the risk of developing Dravet syndrome.” Id.
APPLICATION TO E.O.
The government’s position is that “E.O.’s mutation is
the sole cause of his Dravet syndrome and his resulting
neurological condition.” J.A. 2. Although the science is
still evolving, it is apparent that this simplistic statement
is incorrect.
All of the reported studies show a role of vaccination
in producing seizures in infants with the SCN1A muta-
tion. The Petitioners agree that there is a relationship
between E.O.’s genetic mutation and his seizures and
ensuing disabilities; they argue that “his DTaP vaccina-
tion in conjunction, with his SCN1A mutation . . . likely
OLIVER v. HHS 11
caused his seizure disorder, encephalopathy, and devel-
opmental delays.” Reply Br. 1.
It is not known whether E.O. would have manifested
Dravet syndrome without the vaccination. The only
certainty is that E.O. experienced a dramatic reaction
within a few hours of DTaP vaccination, that the seizures
continued, and that there were developmental conse-
quences. The Special Master so acknowledged, but leaped
to the conclusion that “[a]lthough E.O.’s vaccinations may
have caused a fever or otherwise triggered his first sei-
zure, neither that initial seizure nor his vaccinations
caused his Dravet syndrome or neurological complica-
tions.” Oliver v. Sec’y of Health & Human Servs., No. 10-
394V, 2017 WL 747846, at *2 (Fed. Cl. Feb. 1, 2017).
This conclusion does not withstand scrutiny. The sci-
entific studies all show a reasonable likelihood that E.O.’s
vaccination in his first 6 months triggered the adverse
events he suffered. The seizures and fever on the evening
of E.O.’s 6-month DTaP vaccination are recognized in the
scientific literature as likely to have contributed to or
triggered the Dravet syndrome in conjunction with the
SCN1A mutation.
“Likelihood” is the standard of Vaccine Act recovery,
for the Vaccine Act arose because certainty was not avail-
able. Until modern science discovered a genetic founda-
tion for at least some vaccine injury, E.O.’s vaccine
response would have been classified as a “Table Injury”
and routinely entitled to the support of the Vaccine Act.
Though science has begun to understand previously
unexplained responses to vaccines, such understanding
does not alter the Vaccine Act.
Until every infant is genetically analyzed before vac-
cination and all aberrant genes are identified, the Vaccine
Act is the nation’s response to potential vaccine-induced
consequences such as Dravet syndrome. HHS is required
to administer the Vaccine Act in accord with its text and
12 OLIVER v. HHS
purpose. From my colleagues’ contrary ruling, I respect-
fully dissent.