The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: October 15, 2015
* * * * * * * * * * * * * * * PUBLISHED
DWAYNE COZART and MICHELE *
HAMILTON, as representatives of the *
Estate of C.A.C., * No. 00-590V
*
Petitioners, *
* Chief Special Master Dorsey
v. *
*
SECRETARY OF HEALTH * Motion for Reconsideration in Light
AND HUMAN SERVICES, * of Additional Evidence; Vaccine
* Rule 10(e)(1); Manifest Injustice.
Respondent. *
*
* * * * * * * * * * * * * * *
Ronald Craig Homer, Conway, Homer & Chin-Caplan, PC, Boston, MA, for petitioners.
Ryan Daniel Pyles, U.S. Department of Justice, Washington, DC, for respondent.
ORDER DENYING PETITIONERS’ MOTION FOR RECONSIDERATION1
Petitioners, Dwayne Cozart and Michele Hamilton (“petitioners” or the “Cozarts”) filed a
petition under the National Childhood Vaccine Injury Act (“Vaccine Act” or the “Program”),2 as
the representatives of the estate of their son, C.A.C, alleging that C.A.C. “experienced an adverse
reaction to [his October 19, 1998] inoculations which resulted in his death on October 19, 1998.”
Petition at 1. Petitioners filed an amended petition alleging that as a result of the administration
of the hepatitis B (“Hep B”), Diphtheria-Tetanus-acellular-Pertussis (“DTaP”), inactivated polio
(“IPV”), and haemophilus influenzae (“Hib”) vaccines on October 19, 1998, C.A.C. died on
October 19, 1998. Amended Petition at 1, filed Oct. 24, 2011. Respondent recommended
1
In accordance with the Vaccine Rules, each party has 14 days within which to request redaction
“of any information furnished by that party: (1) that is a trade secret or commercial or financial
in substance and is privileged or confidential; or (2) that includes medical files or similar files,
the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine
Rule 18(b); 42 U.S.C. § 300aa-12(d)(4)(B)(2012). Further, consistent with the rule requirement,
a motion for redaction must include a proposed redacted ruling. If, upon review, the undersigned
agrees that the identified material fits within the requirements of that provision, such material
will be redacted.
2
The National Vaccine Injury Act comprises Part 2 of the National Childhood Vaccine Injury
Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-1 et.
seq. (“Vaccine Act”). Individual section references will be to 42 U.S.C. § 300aa of the Vaccine
Act.
against awarding compensation to petitioners. See Respondent’s Report, filed July 15, 2013, at
13.
On June 30, 2015, following a hearing, the undersigned issued a decision denying
compensation to the Cozarts, finding that petitioners had failed to provide preponderant evidence
that the vaccinations C.A.C. received on October 19, 1998, caused his death. Cozart v. Sec’y of
Health & Human Servs., No. 00-590, (June 30, 2015) (“Original Decision”). In reaching that
decision, the undersigned found that petitioners failed to set forth a reliable medical theory
explaining how the vaccines could have caused the alleged injury. Specifically, the undersigned
found that petitioners failed to provide preponderant evidence that vaccines have been identified
as an exogenous stressor implicated in the Triple Risk Model. The undersigned also found that
petitioners failed to show that vaccines cause cytokines to produce an abnormal brainstem
serotonin response or otherwise act in a manner that causes or contributes to Sudden Infant
Death Syndrome (“SIDS”) as petitioners’ experts postulated. In finding that petitioners failed to
prove the second prong of the Althen3 test, a “logical sequence of cause and effect showing that
the vaccination was the reason for the injury,” the undersigned found that there was no evidence
that C.A.C. suffered from symptoms in the manner postulated by petitioners’ experts that would
support a finding that the cytokines played a role in the child’s death. Based in part on a
statement made by a nurse to paramedics, the undersigned found preponderant evidence that the
child was lying on his face, either in the prone or side position, both positions which are strongly
associated with SIDS. As such, the undersigned found that C.A.C. satisfied the Triple Risk
Model of SIDS without the need to consider a speculative risk factor such as the vaccines. Thus,
the undersigned found that petitioners were not entitled to compensation.
On July 21, 2015, petitioners filed a motion for reconsideration (“Motion for
Reconsideration”) of the Original Decision. This motion was granted to the extent that the
motion requested that the Original Decision be vacated. See Order dated July 28, 2015. A
decision determining whether petitioners were entitled to any additional relief (a substantive
change in outcome) was deferred until respondent responded to the Motion for Reconsideration.
Petitioners seek reconsideration of the undersigned’s Original Decision on Althen Prongs
One and Two in light of additional evidence, a medical article by Kashiwagi et al.4 that
petitioners filed in support of their Motion for Reconsideration. The parties’ additional
arguments have been considered. For the reasons discussed below, the Motion for
Reconsideration is DENIED.
I. Facts and Procedural History
The Original Decision sets forth detailed facts about C.A.C.’s medical history. A
synopsis of these facts is that C.A.C. was born on August 17, 1998. At his two week well-child
3
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005)
4
Pet. Ex. 49 (Kashiwagi Y, et al., Production of inflammatory cytokines in response to
diphtheria-pertussis-tetanus (DPT), haemophilus influenza type b (Hib), and 7-valent
pneumococcal (PCV7) vaccines, 10 Hum Vaccine Immunother 3, 677-85(2014)).
2
visit, he was noted to be developing normally. At his two month well-child visit, the pediatrician
again noted that C.A.C. was a well-child. He received the Hep B, DTaP, IPV and Hib
vaccinations during this visit (at approximately 10:15 a.m.). After this visit, C.A.C. was taken to
his babysitter’s home. The babysitter put the child down for a nap. At approximately 2:57
p.m., emergency medical services were dispatched to the babysitter’s house after receiving a
report that C.A.C. was unresponsive. When the Fire Department Emergency Medical Services
(“EMS”) arrived, C.A.C. was pulseless and apneic. CPR was performed and C.A.C. was
intubated and given epinephrine. He was taken to the Charlton Methodist Hospital. Upon
arrival, C.A.C. still had no pulse and was asystolic.
The emergency room physician, Dr. Joe Tsou, documented that C.A.C. had a rectal
temperature of 94.7 degrees, indicating that “significant time had elapsed since the time of
arrest.” Pet. Ex. 8 at 7. Dr. Tsou performed a physical exam and noted “coffee ground vomitus
around [the] mouth,” congested chest, distended abdomen, and paleness. Id. at 8. Resuscitative
efforts were not successful and C.A.C. was pronounced dead at 15:47 (3:47 p.m.). Id. at 7.
An autopsy was performed which revealed “posterior lividity [that was] partially fixed”
and “lividity of the right side of the face with blanching over the pressure areas.” Pet. Ex. 9 at
19. Lividity was also seen on the right ear and neck. Pet. Ex. 12 at 17. The internal examination
revealed petechiae in the lungs with moderately congested parenchyma of the lung. Pet. Ex. 9 at
20. A chest x-ray showed a right pneumothorax. Id. A microscopic examination of the thymus
revealed an increase in “Hassall’s corpuscle.” Id. at 4. The “[h]istologic sections of [the]
medulla at multiple levels reveal[ed] scant arcuate nuclei neurons bilaterally.” Id. at 5. Dr.
Holley, who performed the autopsy, noted that “[a]rcuate nucleus hypoplasia has been reported
in association with infants dying of SIDS.” Id. at 6. The toxicology reports were normal. Id.
The medical examiner concluded that the child’s death should be classified as SIDS. Id. “This
category is used when complete autopsy, investigation and additional studies fail to yield a
definite cause of death. Although there was a recent immunization, a connection to the death
could not be established.” Id.
The Cozarts filed their petition on October 2, 2000. They filed an expert report from Dr.
Douglas Miller, a neuropathologist, on August 6, 2012, and an expert report from Dr. James
Oleske, an immunologist, on December 11, 2013. Respondent filed an expert report from Dr.
Hart Lidov, a neuropathologist, on April 20, 2013. On June 21, 2013, respondent filed an expert
report from Dr. Christine McCusker, an immunologist. A hearing was held on September 25-26,
2014, during which Drs. Miller and Oleske testified for petitioners, and Drs. McCusker and
Lidov testified for respondent.
Following the conclusion of the hearing and submission of briefs, the undersigned found
that petitioners were not entitled to compensation, because petitioners failed to provide
preponderant evidence that the vaccinations C.A.C. received on October 19, 1998, caused his
death. Petitioners filed a Motion for Reconsideration of the Original Decision on July 21, 2015.
That motion was granted to the extent that it vacated the Original Decision. Respondent filed a
response to the Motion for Reconsideration on August 12, 2015. Petitioners filed a Reply brief
on August 26, 2015. The Motion for Reconsideration is now ripe for ruling.
3
II. Analysis
a. Standards for Reconsideration
Vaccine Rule 10(e), which governs motions for reconsideration, provides, “[e]ither party
may file a motion for reconsideration of the special master’s decision within 21 days after the
issuance of the decision . . . .” Vaccine Rule 10(e)(1). A party seeking reconsideration “must
support the motion by a showing of extraordinary circumstances which justify relief.” Fru-Con
Constr. Corp. v. United States, 44 Fed. Cl. 298, 300 (1999). The motion for reconsideration
“must be based ‘upon manifest error of law, or mistake of fact, and is not intended to give an
unhappy litigant an additional chance to sway the court.’” Prati v. United States, 82 Fed. Cl.
373, 376 (2008) (quoting Fru-Con Constr. Corp., 44 Fed. Cl. at 300).
“A court may grant such a motion when the movant shows ‘(1) that an intervening
change in the controlling law has occurred; (2) that previously unavailable evidence is now
available; or 3) that the motion is necessary to prevent manifest injustice.” System Fuels, Inc. v.
United States, 79 Fed. Cl 182, 184 (2007), quoting Amber Resources Co. v. United States, 78
Fed. Cl. 508, 514 (2007). Granting such relief requires “a showing of extraordinary
circumstances.” Caldwell v. United States, 391 F.3d 1226, 1235 (Fed. Cir. 2004) (citation
omitted), cert. denied, 546 U.S. 826, 126 S.Ct. 366, 163 L.Ed.2d 72 (2005). Special masters
have the discretion to grant a motion for reconsideration if to do so would be in the “interest of
justice.” Vaccine Rule 10(e)(3).
Petitioners do not claim that there has been an intervening change in the law, nor do they
contend that there is new evidence that was unavailable at the time the undersigned issued the
Original Decision. Petitioners also admit that while the additional evidence offered with their
motion was available at the time the case was litigated, it “did not seem relevant until the special
master filed her decision,” and therefore was not previously filed. Motion for Reconsideration at
2. Thus, in order to prevail on their Motion for Reconsideration, petitioners must demonstrate
that the denial of their motion would result in manifest injustice. See Hall v. Sec’y of Health &
Human Servs., 93 Fed. Cl. 239, 251 (2010), aff’d 640 F.3d 1351 (Fed. Cir. 2011). As noted by
other special masters, there is little case law interpreting Vaccine Rule 10(e)(3) beyond the
conclusion that it is within the special master’s discretion to decide what the “interest of justice”
is in a given case. See Krakow v. Sec’y of Health & Human Servs., No 03-632V, 2010 WL
5572074, at *3 (Fed. Cl. Spec. Mstr. Jan. 10, 2011) (granting reconsideration of motion to
dismiss case for failure to prosecute).
b. Petitioners’ Motion for Reconsideration
i. Petitioners’ Review of the Original Decision
In requesting reconsideration of the Original Decision, petitioners note that the
undersigned found that they had not presented preponderant evidence under Althen Prongs One
and Two. Petitioners state that it is unclear whether the undersigned found that they had met
their burden under Althen Prong Three, which will be discussed more fully below.
4
With regard to petitioners’ argument that the undersigned did not consider the record as a
whole and simply rejected petitioners’ arguments and chose to accept the opinions of
respondent’s experts, the undersigned must address these statements. This case involves a very
tragic situation, and the undersigned considered all evidence presented by the parties in reaching
her decision. All the evidence and testimony presented in this case was carefully reviewed and
analyzed, and the undersigned did not reach her conclusion lightly. After all the evidence was
analyzed and weighed in accordance with the applicable legal standards, it became clear to the
undersigned that the evidence presented by petitioners could not meet their legal burden, and
thus, entitlement was denied.
Because this case involves significant issues that may have broader implications, the
undersigned granted petitioners’ request to reconsider her decision in light of petitioners’
statement that they had additional evidence to present that they believed the undersigned should
consider. This motion was not granted to allow petitioners a second chance to reargue their case.
For the reasons set forth below, the undersigned finds that petitioners’ arguments in
support of their Motion for Reconsideration are not persuasive. The additional evidence that
petitioners presented is not new evidence; rather, it is an article that was available to petitioners
at the time this case went to hearing. The argument that petitioners did not deem this article
relevant until the undersigned issued her decision is not proper grounds for reconsideration of the
undersigned’s decision. Even if petitioners had presented this article at a time when the
undersigned could have taken it into consideration in reaching her decision, it would not have
changed the outcome. Thus, petitioners’ motion for reconsideration is DENIED.
ii. Althen Prong One
1. Vaccines as Extrinsic Risk Factors of the Triple Risk Model
In the Motion for Reconsideration, petitioners first claim that they have demonstrated a
reliable medical theory causally connecting C.A.C.’s vaccinations and his death. Motion for
Reconsideration at 5. In doing so, petitioners concede that “vaccines have not been scientifically
proven to be an extrinsic risk factor in the Triple Risk Model.” Id. Petitioners argue, however,
that requiring scientific certainty is not a requirement of proving a reliable medical theory. This
statement is correct. Scientific certainty is not a requirement of proving a reliable medical
theory, and the undersigned did not analyze petitioners’ claim according to that standard. In
reaching her conclusion on Althen Prong One, the undersigned found that petitioners failed to
show that their interpretation of the Triple Risk Model, as it relates to vaccines, is a sound and
reliable medical theory. The undersigned noted that petitioners did not present any evidence
demonstrating that vaccines were identified as exogenous stressors implicated in the Triple Risk
model. Both of petitioners’ experts agreed that there were no other medical professionals who
have opined that vaccinations operate similar to infections which are identified as exogenous
stressors for the purpose of the Triple Risk model. Nowhere in her opinion did the undersigned
state or require petitioners to prove with scientific certainty that vaccines are an extrinsic risk
factor in the Triple Risk model. Indeed, one of the reasons petitioners’ arguments failed on
Althen Prong One is because there was little to no evidence presented to support their position,
other than the testimony of Drs. Oleske and Miller. “An expert opinion is no better than the
5
soundness of the reasons supporting it.” Perreira v. Sec'y of Health & Human Servs., 33 F.3d
1375, 1377 n.6 (Fed. Cir. 1994). A special master does not need to credit “expert opinion
testimony that is connected to the existing data or methodology ‘only by the ipse dixit of the
expert,’ or where ‘there is simply too great an analytical gap between the data and the opinion
proffered.’ ” Jarvis v. Sec'y of Health & Human Servs., 99 Fed. Cl. 47, 61 (2011) (quoting
Cedillo v. Sec'y of Health & Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010).
2. Vaccinations versus Infections and Inflammatory Processes
In their Motion for Reconsideration, petitioners state that “the one piece of evidence
purportedly lacking (evidence typically not required in Vaccine Program proceedings) is
evidence that the cytokines produced by vaccination are the same or similar to the cytokines
produced by infections.” Motion for Reconsideration at 10. Petitioners’ theory of causation is
fully detailed in the Original Decision, but a summary is provided here.
Petitioners’ theory of causation is based on the Triple Risk Theory developed by Dr.
Hannah Kinney and her colleagues. Drs. Miller and Oleske explained that the Triple Risk
Theory involves “a vulnerable infant, who during a critical time, encounters external stressor(s),
resulting in death.” Id. According to this theory, the infant is vulnerable due to a defective
serotonergic (“5-HT”) system. Id. at 10. At autopsy, C.A.C. was found to have hypoplasia of
the arcuate nucleus of his brain. Id.; Pet Ex. 4 at 12-13. If an infant has a defective 5-HT
system, the ability to arouse in hypoxic conditions will be compromised. According to
petitioners’ theory
[i]f the increased cytokine production secondary to mild infection
or inflammatory process (such as vaccination) is superimposed on
this vulnerable infant, her ability to respond or arouse is further
compromised. In this regard, the evidence is clear that cytokines
such as IL-1ß have an inhibitory effect on 5-HT neurons, meaning
that cytokine interaction with 5-HT neurons will decrease their
firing and thereby dampen the arousal response.
Pet. Post-Hearing Brief at 13.
In order for petitioners’ theory to succeed, petitioners would need to demonstrate that the
activation of an immune response to a vaccination is similar to that of an infection. Petitioners
argue that the evidence in this case “clearly demonstrates that a mild infection or a mild
inflammatory process can be external risk factors in SIDS.” Motion for Reconsideration at 7.
Petitioners further state that the evidence “shows that vaccinations trigger the immune system
and promote the production of pro-inflammatory cytokines. In this regard, then, vaccinations
clearly meet the definition of a ‘mild inflammatory process’ as described in the filed evidence.”
Id. at 8.
The evidence does not support this assertion. First, infections have been identified as
exogenous stressors for the Triple Risk Model. Vaccinations have not. As Dr. McCusker
testified, there are important similarities and differences between an immune response to an
infection and an immune response to a vaccination. Tr. 138. One important difference is that an
6
infection is a live organism that has the ability to replicate in the body and cause a severe
immune reaction. A live virus will infect a cell directly and the virus within the cell will begin to
replicate. What begins as a few infected cells can quickly become thousands of infected cells.
The vaccines C.A.C. received, on the other hand, are composed of particulate killed organisms,
i.e., pieces of organisms. Administered alone, these particles may not elicit much of an immune
response beyond a local reaction. Adjuvants are added to vaccines to elicit a greater immune
response from the body to protect an individual who may later be exposed to the live virus. Dr.
Oleske, petitioners’ immunologist, testified that vaccines try to mimic what infections do in the
body “without the profound negative effects of natural infection.” Tr. at 12. He explained that
vaccinations elicit “an adequate response that allows a protective immune response, without
overwhelming complications.” Tr. at 15.
Regarding the timing of an immune response from a vaccination, the experts had
differing opinions. Dr. Oleske testified that when a vaccination is administered into the body,
there is a local inflammatory response at the site of the injection. The local response becomes
systemic “in that fairly short period of time … [a]nd in the case of what we’ve been talking
about, SIDS, that inflammatory response circulates very rapidly through the body to the central
nervous system, and in the arcuate nucleus in a vulnerable infant…” Tr. 74. Dr. McCusker, on
the other hand, testified that when studies were conducted to look “at the pattern of the way the
immune response occurs, it actually stays quite local for a significant period of time.” Tr. 140.
For example, if a vaccine is administered in the thigh, the initial activation event would occur in
“the thigh, and then it would lead up to the draining lymph node in the groin on that side, and it
takes a significant … in the studies where they have looked at this, it actually takes a significant
amount of time…” Id. Dr. McCusker testified that “in terms of looking at activation of immune
responses in general, you are talking about several hours for the pro-inflammatory activation to
ramp itself up, and then you’re talking about several days for the dissemination of that
information beyond the regional lymph node.” Tr. at 141. Dr. McCusker did state, however,
that there may be signs and symptoms of the pro-inflammatory response occurring in the six to
twelve hours after administration of the vaccine, but in “the initial few hours, [the immune
response] is very local” as has been reported in the medical literature. Id. When asked whether
there was any evidence of an inflammatory process occurring in C.A.C. at the time of his death,
Dr. Oleske responded that the “pathology showed that [C.A.C.] had a negative area in the brain
that has been linked to that type of death [SIDS].” Id. at 40. But other than C.A.C.’s death, Dr.
Oleske stated that there was no other pathological evidence of an inflammatory process
occurring. Id.
The undersigned also notes that the evidence submitted in this case identifies common
infections that have been associated with SIDS death, including upper respiratory tract infections
and gastrointestinal infections, two types of infections that can affect the breathing mechanics of
an infant from either congestion or reflux. Tr. at 197, 252. While not confined to just these types
of infections, Dr. McCusker is the only expert who provided an opinion explaining how these
infections might contribute to SIDS deaths. Vaccinations do not act in the same way as these
infections because vaccinations do not interfere with the mechanics of breathing. Tr. 170-71.
7
3. Petitioners’ Additional Evidence – Kashiwagi et al., Article
Assuming that petitioners are able to succeed in providing preponderant evidence that
vaccinations act similar to infections, the next step would be to provide preponderant evidence
that the cytokines released in response to a vaccination act in the same way as cytokines released
in response to an infection or an inflammatory process. In support of this proposition and in
support of their Motion for Reconsideration, petitioners introduced exhibit 49, an article by
Kashiwagi5 et al. published in March 2014, to demonstrate that the DTaP and Hib vaccinations,
which C.A.C. received, led to the production of cytokines IL-1ß, IL-6 and TNF-, which are the
same cytokines that are produced by infection. These are the same cytokines that petitioners
theorize are implicated in their interpretation of the Triple Risk Model. Motion for
Reconsideration at 11. Upon review of this article, the undersigned notes that the purpose of the
Kashiwagi study was to compare levels of inflammatory cytokines6 in the serum of 61 vaccine
recipients with febrile reactions and 18 recipients without febrile illness within 24 hours of
vaccination. There was no significant difference between the two groups except that the
cytokine G-CSF was elevated in individuals with a febrile illness. The significance of this
finding was not determined. In fact, the authors state as follows:
Vaccine-specific innate inflammatory responses are clearly important, and
have not been sufficiently investigated regarding cytokine production
using difference vaccines. . . . “
Id. at 678. The study was not designed to examine the effects of cytokines in the brain following
vaccination. Of interest, however, is the authors’ report that cytokine production begins six
hours after stimulation. Id. at 679. The authors state that, “when a vaccine is administered
through an intramuscular or subcutaneous route, the antigen is transported from the muscle tissue
to the regional lymph nodes, where immune responses occur.” Id. This supports Dr.
McCusker’s testimony at hearing. See Tr. at 141.
The undersigned does not take issue with petitioners’ argument that vaccinations result in
a cytokine release, and that some of these cytokines are the same cytokines that are released in
response to infection. It is petitioners’ argument about how the cytokines produced in response
to a vaccination have a negative effect on the brain and 5-HT system that is not persuasive.
To carry that argument, petitioners needed to show how cytokines produced in response
to a vaccination appear in the brain, and lead to the death of an infant. But, petitioners’ theory
fails because it is based on an outdated theory of the role of cytokines in the brain and on the 5-
HT system. The current and persuasive understanding of cytokines, as discussed by
respondent’s experts, shows that the cytokines in the brain identified by petitioners’ experts do
not cause a pathologic event. Tr. 183
5
Pet. Ex. 49 (Kashiwagi Y, et al., Production of inflammatory cytokines in response to
diphtheria-pertussis-tetanus (DPT), haemophilus influenza type b (Hib), and 7-valent
pneumococcal (PCV7) vaccines, 10 Hum Vaccine Immunother 3, 677-85(2014)).
6
The cytokines include IL-1ß, IL-4, IL-6, IL-10, IL-12, IFN-y, M1P-1, TNF-, PGE2, and G-
CSF.
8
To explain how the role of cytokine expression and its effect on the brain has evolved,
Dr. McCusker testified that in 2003, immunologists were researching SIDS deaths and were
beginning to study the role of cytokines in the brain. Those early studies showed that the pro-
inflammatory cytokine, IL-1ß, was present in the brains of SIDS infants. The question, at the
time, was whether this inflammation was involved in or contributed to sudden infant death.
Petitioners’ theory is premised on the idea that the cytokine expression in the SIDS brain causes
inflammation and SIDS death in a vulnerable infant. Tr. 38, 55, 85. The current research
demonstrates that the brain regularly produces pro-inflammatory cytokines as part of a normal,
regulatory process. The existence of these cytokines is not an indication that the brain is
constantly inflamed. Tr. 159. Dr. McCusker explained that to further investigate this
observation, a study was performed where a large amount of the cytokine IL-6 was introduced in
the brain of piglets. In these animal models, it was found that the overexpression of IL-6 did not
have a significant effect on respiration and the 5-HT system. The study demonstrated that there
was some small effect, but it did not appear to be significant and did not negatively affect
respiration.7 Similar to IL-6, IL-1ß, another cytokine identified in petitioners’ theory to have a
negative impact on the 5-HT system, was also found to be expressed normally in brain cells. Tr.
165, 171-72; Pet. Ex. 35.8 Dr. McCusker testified that these cytokines are likely being
upregulated in the brain cells of SIDS infants because the brain has identified a stressor. Tr. 167.
Thus, the cytokines are an indicator of stress and not a cause or contributor. Dr. Miller admitted
that the literature he presented in support of his theory of a negative effect of cytokines on the
brain, was literature only discussing the expression of cytokines, not the effect. He stated that he
was not aware of any data on the effect of these cytokines. Tr. at 365-66.
In discussing the articles cited by petitioners’ experts regarding the role of cytokines, Dr.
McCusker repeatedly demonstrated that the information upon which petitioners’ theory is based
is outdated. New information and a greater understanding of the role of cytokines is available
and respondents’ experts provided a detailed discussion on the current understanding.
Petitioners’ experts did little to dispute this information. Thus, the undersigned found that
petitioners had not presented preponderant evidence to both set forth a reliable medical theory
and logical sequence of cause and effect, i.e., Althen Prongs One, and Two which is discussed
more fully below.
iii. Althen Prong Two
In the Motion for Reconsideration, petitioners stated that they have “provided a wealth of
evidence of sudden infant death syndrome occurring shortly after vaccinations, including the
same vaccinations received by C.A.C.” Motion for Reconsideration at 6. However, temporal
association alone is not evidence of causation. See Grant v. Sec’y of Health & Human Servs.,
956 F.2d 1144, 1148 (Fed. Cir. 1992).
7
Resp. Ex. A. Tab 11 at 4-5; A. Vege et al., Are Elevated Cerebrospinal Fluid Levels of IL-6 in
Sudden Unexplained Deaths, Infectious Deaths and Deaths Due to Heart/Lung Disease in Infants
and Children Due to Hypoxia?, 87 Acta Paediatrica 819, 819-24 (1998).
8
Brambilla et al., Interleukin-1 inhibits firing of serotonergic neurons in the dorsal raphe nucleus
and enhances GABAergic inhibitory postsynaptic potentials, 26 Eur J Neuroscie 1862-69 (2007).
9
Next, petitioners state that the undersigned held that “petitioners offered no evidence that
‘peripheral cytokines released in response to the vaccines . . . communicated with the central
nervous system[.]” This statement is only partially accurate. Quoting from the Original
Decision, the undersigned stated “that petitioners did not offer preponderant evidence
demonstrating that the peripheral cytokines released in response to the vaccines administered to
C.A.C. communicated with the central nervous system to invoke an abnormal brain response in
the manner described by Dr. Oleske and Dr. Miller.” (emphasis added). In a footnote, the
undersigned noted that respondent’s expert, Dr. McCusker, agreed that there is communication
between the peripheral body and the central nervous systems, and that cytokines played a role in
the communication. But, Dr. McCusker did not agree with petitioners’ experts’ contention that
cytokines played a pathological role. Petitioners argue that the undersigned required them to
present direct evidence of communication between the cytokines produced by vaccination and
the peripheral system. This argument is wholly misplaced. Nowhere in the Original Decision
did the undersigned require petitioners to present direct evidence of their theory.
Next, in response to the undersigned’s finding that there is no clinical evidence that
cytokines played a role in C.A.C.’s death, petitioners take issue with the fact that the undersigned
referenced Dr. Oleske’s testimony that C.A.C. experienced a cytokine storm. Petitioners argue
that a “cytokine storm was not discussed in either of petitioners’ expert reports,” and that it was
“not a concept embraced as a cause of SIDS in the medical literature.” Motion for
Reconsideration at 14. Nonetheless, petitioners agree that Dr. Oleske used the terminology
“cytokine storm” during his testimony at hearing. Petitioners argue, however, that “Dr. Oleske
clearly did not mean cytokine storm in the traditional sense and his use of language should not be
used to import a different meaning to his testimony. Rather, he referred to the evidence showing
a hypertuned or exaggerated cytokine response in SIDS death.” Motion for Reconsideration at
15. Essentially, what petitioners have asked the undersigned to do is to speculate on the meaning
of Dr. Oleske’s testimony and to assign a meaning to his testimony that he did not provide. The
undersigned cannot, and will not, speculate in a manner that is contrary to the direct testimony
provided by petitioners’ own experts. If petitioners took issue with the testimony of their expert,
they had ample opportunity to clarify the record, either during the hearing on direct, or redirect
questioning, or even in their post-hearing brief. Petitioners failed to do so, and a motion for
reconsideration is an improper method to explain or further clarify an expert’s testimony at
hearing. Even if the undersigned were to accept petitioners’ suggested interpretation of Dr.
Oleske’s testimony regarding a cytokine storm, it would not change the outcome of this Motion
for Reconsideration or the Original Decision. The undersigned would still find that C.A.C. did
not exhibit any clinical signs that cytokines played a causal role in his death.
It is also important to note that in the Original Decision, the undersigned found that
C.A.C. fit the Triple Risk Model without need to consider a speculative risk factor, such as
vaccines. The child was found in the prone or side position, exogenous risk factors that, alone,
would satisfy the Triple Risk Model. It was for these additional reasons that the undersigned
concluded that petitioners failed to provide preponderant evidence of a logical sequence of cause
and effect showing that C.A.C.’s vaccinations caused his death.
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iv. Althen Prong Three
Petitioners state that they were unclear whether the undersigned found that they met their
burden on Althen Prong 3. To clarify, in the Original Decision, and the undersigned found that
there was a temporal relationship between C.A.C.’s vaccinations and his death. But without a
plausible medical theory and logical sequence of cause and effect upon which to base a finding
regarding Althen Prong 3, the undersigned simply could not find that petitioners met their burden
on this prong. The temporal relationship is not enough. See Grant v. Sec'y of Health & Human
Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (holding “a proximate temporal association alone
does not suffice to show a causal link between the vaccination and the injury”). The undersigned
only noted in the Original Decision that the child’s death took place at a point in time that would
warrant consideration of the vaccinations as the potential cause of the child’s injury.
c. Summary
Petitioners’ medical theory is reliant on the proposition that the vaccinations are
exogenous stressors. Petitioners have failed to demonstrate, by a preponderance of the evidence,
that the vaccinations act similarly to the other exogenous stressors that have been identified for
the Triple Risk Model. As is set forth in the Original Decision, petitioners and their experts have
failed to identify any medical professional who has identified vaccinations as exogenous
stressors or to even postulate that vaccinations may act as exogenous stressors in the Triple Risk
Model. Even if petitioners were successful in providing evidence that vaccinations produced
cytokine effects in the brain similar to that of infections, petitioners’ theory still fails because
they have not shown that the cytokines have a negative impact on the brain that would lead to
SIDS death.
Petitioners’ additional evidence, exhibit 49, the Kashiwagi article, has been reviewed and
considered. The undersigned finds that it does not change the reasoning or conclusion of the
Original Decision. Thus, even considering this additional evidence, the undersigned finds that
there is no manifest injustice by denying petitioners’ Motion for Reconsideration.
The undersigned must also note that in many similar SIDS cases heard by special masters
in the Vaccine Program (and upheld on review), entitlement was denied to petitioners because of
the lack of sufficient proof of causation. See generally Doe/11 v. Sec’y of Health & Human
Servs., __ F.3d __ (Fed. Cir. 2010)(the court upheld special master’s decision that a death
labeled “SIDS” was not caused by a hepatitis B vaccine); Nordwall v. Sec’y of Health & Human
Servs.,, No. 05-0123v, 2008 WL 857661 (Fed. Ct. Cl. Spec. Mstr. Feb. 19, 2008)(special master
held that SIDS death of an infant was not due to a vaccine, but rather “positional asphyxia”);
Waterman v. Sec’y of Health & Human Servs., No. 13-960v, 2015 WL 4481244 (June 30,
2015)(aff’d on appeal)(special master denied entitlement in a SIDS case finding that petitioners
did not prove that their child suffered an encephalopathy prior to his death); Sanchez v. Sec'y of
Health & Human Servs., No. 11-651V, 2013 WL 4476750 (Fed. Cl. July 26, 2013)(special
master held that petitioner failed to prove that vaccinations caused SIDS death); Bigbee v. Sec'y
of Health & Human Servs., No. 06-663V, 2012 WL 1237759, at *49 (Fed. Cl. Mar. 22,
2012)(special master held that petitioners failed to produce preponderant evidence that the
vaccines caused the child’s death); Heller v. Sec’y of Health & Human Servs., No. 96-797V,
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1998 WL 408612(Fed. Ct. Cl. Spec. Mstr. June 22, 1998)(special master held that studies did not
show a causal link and that petitioner failed to demonstrate a causal relationship between DPT
vaccine and child’s SIDS death).
III. Conclusion
For the aforementioned reasons, the undersigned hereby DENIES petitioners’ Motion for
Reconsideration. The Original Decision will be reinstated and considered filed as of today’s
date, October 15, 2015.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
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