CHASE BOATMON, MAURINA CUPID, PARENTS OF J.B., DECEASED, Petitioners-Appellants
SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee
from the United States Court of Federal Claims in No.
1:13-vv-00611-TCW, Judge Thomas C. Wheeler.
Pepper, Conway Homer, PC, Boston, MA, argued for
petitioners-appellants. Also represented by Ronald C. Homer.
G. Ward, Torts Branch, Civil Division, United States
Department of Justice, Washington, DC, argued for
respondent-appellee. Also represented by Robert Paul Coleman,
III, Joseph H. Hunt, C. Salvatore D'Alessio, Catharine E.
Prost, Chief Judge, Newman and Wallach, Circuit Judges.
case, brought under the National Childhood Vaccine Injury Act
of 1986, 42 U.S.C. §§ 300aa-1 to -34, as amended
(the "Vaccine Act"), presents the question of
whether Petitioners Chase Boatmon and Maurina Cupid have
proven by a preponderance of the evidence that the
vaccinations their son, J.B., received caused or
substantially contributed to his death from sudden infant
death syndrome ("SIDS"). The Special Master found
that Petitioners had met their burden and were entitled to
compensation. Boatmon v. Sec'y of Health & Human
Servs., No. 13-611V, 2017 WL 3432329 (Fed. Cl. Spec.
Mstr. July 10, 2017) ("Special Master
Decision"). The United States Court of Federal
Claims reversed the Special Master's finding. Boatmon
v. Sec'y of Health & Human Servs., 138 Fed.Cl.
566 (2018). While we disagree with most of the Court of
Federal Claims' rationale, for the reasons explained
below, we affirm its judgment.
was born four weeks prematurely on April 7, 2011. Special
Master Decision, at *4. Despite being born prematurely,
J.B. was progressing with normal growth and development. At
his four-month well baby visit on September 2, 2011, J.B. was
healthy, with normal chest and lungs and no fever, nasal
congestion, or cough. At that appointment, J.B. received
vaccinations for diphtheriatet-anus-acellular pertussis
(DTaP), inactivated polio (IPV), pneumococcal conjugate
(PCV), rotavirus, and Hepatitis B (Hep B). Id.
that evening, J.B. reportedly had a fever and did not sleep
well. See id. at *5. At 4:00 AM on September 3,
2011, J.B.'s parents gave him Advil for his fever, and he
went back to sleep. By approximately 8:00 AM, J.B. was again
running a fever and was given another dose of Advil.
early afternoon, J.B.'s father put him down for a nap on
his back in his crib. J.B.'s mother checked on him and
replaced his pacifier. She returned to check on him a second
time and found him unresponsive on his right side. At 2:39
PM, J.B.'s mother called 911 and attempted CPR.
Responders arrived at the house within minutes and
transported J.B. to the hospital. Efforts to resuscitate J.B.
were unsuccessful and he was pronounced dead at 4:01 PM.
See id. at *6.
investigation and scene reenactment indicated that J.B. was
placed to sleep on his back and was found on his right side.
Photographs of the scene showed that his crib contained soft
blankets and a flat soft pillow but no clutter or toys.
medical examiner performed an autopsy and concluded that the
cause of death was SIDS. Id.
Vaccine Act, enacted in 1986, created the National Vaccine
Injury Compensation Program, through which claimants can
petition to receive compensation for vaccine-related injuries
or death. See 42 U.S.C. § 300aa-10(a).
are two ways a petitioner can qualify for compensation under
the program. First, if the petitioner can establish an injury
listed on the Vaccine Act Injury Table that occurred after
the administration of a designated vaccine within a
designated period of time ("Table cases"), then
causation is presumed. See id. §§
300aa-11(c), 300aa-14(a). Second, if the petitioner claims an
injury not listed in the Vaccine Act Injury Table
("off-Table cases"), the petitioner must prove, by
a preponderance of the evidence, that the vaccine was the
cause-in-fact of the claimed injury. Id.
§§ 300aa-11(c)(1)(C)(ii)(I), 300aa-13(a)(1).
"[A] proximate temporal association alone does not
suffice to show a causal link between the vaccination and the
injury." Grant v. Sec'y of Dep't of Health
& Human Servs., 956 F.2d 1144, 1148 (Fed. Cir.
1992); see also LaLonde v. Sec'y of Health &
Human Servs., 746 F.3d 1334, 1341 (Fed. Cir. 2014)
("As we have stated before, a temporal correlation alone
is not enough to demonstrate causation."). The
dissent's suggestion that temporal proximity of the
vaccination to the injury creates a prima facie case of
connection or causation is contrary to our precedent. Dissent
to prove causation in fact in an off-Table case, the
show by preponderant evidence that the vaccination brought
about [the] injury by providing: (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
Moberly v. Sec'y of Health & Human Servs.,
592 F.3d 1315, 1321-22 (Fed. Cir. 2010) (quoting Althen
v. Sec'y of Health & Human Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005)). These requirements are known as
the three Althen prongs. If a petitioner proves all
three Althen prongs by a preponderance of the
evidence, he or she is entitled to recover unless the
government shows "by a preponderance of evidence that
the injury was in fact caused by factors unrelated to the
vaccine." Althen, 418 F.3d at 1278 (quoting
Knudsen v. Sec'y of the Dep't of Health &
Human Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)).
parents filed a petition for compensation under the Vaccine
Act, alleging that the vaccinations their son received
contributed to his death from SIDS. Because this was an
off-Table case, the Petitioners were required to prove
causation in fact by establishing each of the three
Al-then prongs by a preponderance of the evidence.
case was assigned to a Special Master, who held an
evidentiary hearing. The Special Master considered medical
and scientific literature as well as expert testimony from
Dr. Douglas Miller for the Petitioners and Dr. Christine
McCusker and Dr. Brent Harris for the government.
parties do not dispute that J.B.'s cause of death was
SIDS. See Special Master Decision, at *6. "SIDS
is defined as 'the sudden death of an infant under one
year of age which remains unexplained after a thorough case
investigation, including performance of a complete autopsy,
death scene investigation, and review of the clinical
history.'" Id. at *7 (quoting James J.
Filiano & Hannah C. Kinney, Arcuate Nucleus
Hypoplasia in the Sudden Infant Death Syndrome, 51 J.
Neuropathology & Experimental Neurology 394 (1992)).
Studies indicate that SIDS occurs during sleep or transitions
between sleep and waking. Id.
Hannah C. Kinney, a neuropathologist at Harvard, is an
undisputed leader in SIDS research and understanding. In
1994, Dr. Kinney and her colleagues "synthesized many
neuropathological studies into their proposed 'Triple
Risk Model.'" Id. This model posits that
SIDS is "multifactorial," occurring "when: (1)
an infant in a critical development period; (2) possessing an
underlying vulnerability; (3) encounters an exogenous
stressor." Id. at *7-8, *33. The following Venn
diagram has been used to illustrate the Triple Risk Model:
first factor, the critical development period, was initially
defined as the first year of life, but has more recently been
understood to be the first six months of life. Id.
at *8. The second factor, an underlying intrinsic
vulnerability in the infant, includes prematurity,
"'male gender, African-American race, poverty,
adverse prenatal factors such as maternal smoking or alcohol
use during pregnancy, . . . genetic polymorphisms,
'" and "brainstem abnormality in the
neuroregulation of cardiorespiratory control."
Id. (quoting Hannah C. Kinney et al., The
Brainstem and Serotonin in the Sudden Infant Death
Syndrome, 4 Annu. Rev. Pathol. Mech. Dis. 517, 519, 521
(2009) (J.A. 553-88) ("Kinney 2009")). The third
factor, exogenous stressors, has been identified in the
literature to include "prone sleep position, face-down
position, covered face in the supine position, soft bedding,
bed sharing, over-bundling, elevated room temperature, and
minor infection at the time of death." Id. at
*10 (citing Kinney 2009, at 519 (J.A. 555)).
Miller, the Petitioners' expert, theorized that receiving
a vaccine can be an exogenous stressor for SIDS because its
prompts the upregulation of cytokines. Id. at *21
("Dr. Miller stated that vaccinations can be an
extrinsic risk factor in SIDS, as they prompt the
upregulation of cytokines that, among other things, produce
fever."). According to Dr. Miller, the upregulation of
cytokines following vaccinations can be similar to the
upregulation of cytokines associated with a mild infection, a
known extrinsic risk factor for SIDS. Id. at *20-21.
Dr. Miller theorized that the cytokines can inhibit the
activity of 5-hydroxytryptamine ("5-HT" or
serotonin) neurons in the medulla causing prolonged apneas
and interference with autoresuscitation. Id.
Approximately 50-70% of infants who die of SIDS appear to
have abnormalities in the medullary 5-HT system. Id.
at *8. According to Dr. Miller's theory, "[w]hen the
vaccines are administered in the presence of the defects in
the medulla, during the critical developmental period, they
are likely to have a similar effect as mild infection that
may cause a failure of the medullary response system and
ultimately a death." Id. at *21. But
by Dr. Miller's own admission, no other medical
professionals or researchers have adopted his theory.
See J.A. 161-62; see also Special Master
Decision, at *21.
McCusker disagreed with Dr. Miller's theory.
Specifically, she disagreed that upper respiratory
infections- and by Dr. Miller's extension,
vaccinations-act as neuro-chemical exogenous
stressors. Special Master Decision, at *23. Instead,
Dr. McCusker testified that upper respiratory infections,
like the other identified exogenous stress-ors, are
mechanical, meaning that they interfere with an
infant's ability to exhale carbon dioxide and inhale
fresh oxygen. Id. at *23, *25.
Special Master found that the Petitioners had established all
three Althen prongs by a preponderance of the
evidence. On Althen prong one, the Special Master
adopted Dr. Miller's extension of the Triple Risk Model,
concluding that "vaccines can . . . play a critical role
. . . by stimulating the production of inflammatory
cytokines." Id. at *39. We note for clarity
that the Special Master also stated that "I have not
concluded that vaccines present a substantial risk of SIDS.
In fact, the evidence is to the contrary." Id.
second Althen prong, the Special Master found that
"the cytokines triggered by the vaccines" in
combination with "other intrinsic and/or extrinsic risk
factors in the presence of a defective or underdeveloped
brainstem seems likely to have produced the perfect
storm that resulted in J.B.'s death." Id.
at *41 (emphasis added). The Special Master's analysis of
the second Althen prong therefore depends on J.B.
having a defective or underdeveloped brain-stem. But notably,
the autopsy did not examine or section J.B.'s arcuate
nucleus or other medullary areas to determine whether J.B.
had any such brainstem abnormality. Id. at *7,
*30-31. The Special Master found that the Petitioners had
proven by a preponderance of the evidence that J.B. had a
brainstem abnormality based, in part, on statistical evidence
that a brainstem defect is found in 50-70% of SIDS cases and
Dr. Miller's testimony that, based on this statistical
evidence, J.B. likely had the defect. See id. at
Special Master also found that Petitioners had established
the temporal requirement of the third Althen prong.
See id. at *42. The Special Master therefore found
in favor of the Petitioners. Id. at *42-43.
government sought review of the Special Master's decision
in the Court of Federal Claims. The Court of Federal Claims
reversed the Special Master, finding "as a matter of law
that the Special Master erred in ruling for Petitioners, and
in finding that Petitioners had met their burden of proof as
established by applicable statutes and case law."
Boatmon, 138 Fed.Cl. at 567; see also id.
at 571 (faulting the Special Master's "improper
application of the standard of proof required in vaccine
Court of Federal Claims reviewed four decisions by three
other Special Masters that considered Dr. Miller's theory
of vaccination causation in other SIDS cases and
"uniformly found that the evidence presented by Dr.
Miller to prove his theory of vaccine causation was not
persuasive." Id. at 571. Despite
acknowledging that "[a] Special Master is not bound to
follow the opinions of other Special Masters," the Court
of Federal Claims criticized the Special Master for
"ma[king] no acknowledgement of the other cases reaching
opposite conclusions and ma[king] no attempt to distinguish
the instant case from any of the others." Id.
Court of Federal Claims determined that the Special Master
erred by accepting Dr. Miller's theory because it was not
"supported by a 'sound and reliable' medical or
scientific explanation" because it has "not been
accepted by any other experts in the field of SIDS
research." Id. at 571- 72 (quoting
Knudsen, 35 F.3d at 548). In doing so, the Court of
Federal Claims invoked Daubert and criticized Dr.
Miller's theory for not having "been subjected to
peer review and publication." Id. at 572
(citing Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 593 (1993)). According to the Court of Federal
Claims, by accepting Dr. Miller's unsupported theory, the
Special Master "applied a standard so low as to
constitute clear error." Id.
Court of Federal Claims reversed the Special Master,
concluding that "having found that Petitioners failed to
satisfy Althen Prong One, the Court also finds that
they have not presented a persuasive basis for finding that
the vaccinations caused J.B.'s death, as required under
Althen Prong Two." Id.
Petitioners appealed the Court of Federal Claims'
decision. We have jurisdiction pursuant ...