Eamick v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
******************** *
JEREMY EAMICK, *
*
Petitioner, * No. 15-519V
* Special Master Christian J. Moran
v. *
* Filed: May 15, 2018
SECRETARY OF HEALTH *
AND HUMAN SERVICES, * Entitlement, hepatitis A vaccine,
* hepatitis B vaccine, GBS, cytokines,
Respondent. * concurrent illness.
*********************
Edward M. Kraus, Law Offices of Chicago Kent, Chicago, IL, for petitioner;
Lisa Ann Watts, United States Dep’t of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT1
Petitioner, Jeremy Eamick, alleges that the hepatitis A and hepatitis B
vaccines that he received on June 15, 2012 and July 17, 2012, caused him to
develop the Miller-Fisher variant of Guillain-Barré syndrome (“GBS”).2 Mr.
Eamick is seeking compensation pursuant to the National Childhood Vaccine
Injury Compensation Program, codified at 42 U.S.C. § 300aa−10 through 34
(2012).
The parties do not dispute that an upper respiratory infection (“URI”)
affecting Mr. Eamick in the month leading to the onset of his GBS was a but-for
1
The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), requires that the Court post this decision on its
website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing
redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4).
Any redactions ordered by the special master will appear in the document posted on the website.
2
Miller-Fisher syndrome is a variant of GBS that is found in a small subset of the United
States GBS population. Tr. 72, 101. For the purposes here, Mr. Eamick’s condition is referred
to as GBS since, according to petitioner, the fact that his GBS was of the Miller-Fisher variant is
not important to his theory of causation. Tr. 73, 76.
1
cause of his GBS. However, petitioner’s expert, Dr. Eric Gershwin, adds that the
infection was not sufficient to cause Mr. Eamick to develop GBS and that it was
the vaccines that transformed the relatively ubiquitous URI into an infection that
ultimately caused Mr. Eamick to develop GBS. Respondent’s expert, Dr. Penelope
Morel, disagrees. She argues that Mr. Eamick’s URI was sufficient to cause his
GBS.
Under the framework for determining causation promulgated by the Federal
Circuit, Mr. Eamick has met his burden for proving entitlement to compensation.
Mr. Eamick presents a logical sequence of cause and effect connecting the
vaccination and the injury, which is based on a persuasive medical theory and a
showing that the temporal sequence is appropriate. Further, the Secretary has not
established that a factor unrelated to the vaccination is the cause of Mr. Eamick’s
symptoms.
I. Facts
The facts of Mr. Eamick’s case are not in dispute. Mr. Eamick was 33 years
old when he developed GBS in July 2012. The month before, Mr. Eamick reported
for basic training in the Army National Guard. Exhibit 1 at 6. As part of his
service, Mr. Eamick received vaccines for adenovirus 4 and 7, bicillin, hepatitis A
and hepatitis B, meningococcal, polio IPV, and tetanus-diphtheria-pertussis on
June 15, 2012. Exhibit 11 at 1. Three weeks later, on July 7, 2012, Mr. Eamick
went to the clinic with complaints of congestion, cough, and sinus discharge.
Exhibit 8 at 54. Ten days following this visit, on July 17, 2012, Mr. Eamick was
vaccinated again with the second administration of the hepatitis A and hepatitis B
vaccines. Exhibit 11 at 1. During this time, Mr. Eamick’s respiratory infection
had been progressively worsening and he reported to the clinic again on July 21,
2012. Exhibit 8 at 50. At this visit, he was diagnosed with bronchitis and was
prescribed an antibiotic. Id.
Dr. Gershwin and Dr. Morel agree that Mr. Eamick’s GBS first manifested
on July 24, 2012. Tr. 108, 200. On that date, he went to the emergency
department at Fort Leonard Wood Hospital complaining of difficulty speaking,
difficulty with coordination, and numbness in his face, hands, and feet. Exhibit 1
at 39. He was discharged and ordered to bed rest. Id. at 43. He returned to the
same hospital the next day when he had difficulty walking and performing his
duties. Id. at 44-45. The hospital diagnosed him with an acute neurological injury.
Exhibit 8 at 7. The hospital also recommended that Mr. Eamick be sent to the
2
University of Missouri Hospital, which he was later that same day, July 25, 2012.
Id.; exhibit 1 at 53.
Mr. Eamick was hospitalized at the University of Missouri hospital for
longer than two weeks. See exhibit 2. Testing found anti-GQ1b antibodies, which
confirmed a diagnosis of GBS.3 Id. at 68. Although Mr. Eamick received
extensive care, including plasmapheresis and physical therapy, he continues to
experience disability due to the GBS. See exhibit 12 at 1-5. Both experts
characterized Mr. Eamick’s case to be a particularly severe form of GBS. Tr. 96,
184.
Mr. Eamick filed his petition for compensation on May 21, 2015. On
November 4, 2015, respondent filed his Rule 4(c) report, stating that there was,
among other deficits, insufficient evidence linking vaccinations to GBS. See
Resp’t’s Rep., filed Nov. 4, 2015, at 7-10.
Mr. Eamick filed two reports from Dr. Gershwin in support of his claim for
compensation (exhibits 25 and 113). The Secretary filed two responsive reports
from Dr. Morel (exhibits B and DD).4 A one-day entitlement hearing was held on
September 13, 2017. Mr. Eamick, Dr. Gershwin, and Dr. Morel testified in the
hearing.
II. The Experts’ Qualifications and Assessment
A. Dr. Eric Gershwin, M.D.
Dr. Gershwin is a Distinguished Professor of Medicine with the University
of California at Davis, where he currently holds a chaired professorship in honor of
Jack and Donald Chia. Dr. Gershwin received his undergraduate degree, summa
cum laude, from Syracuse University and his medical degree from Stanford. He
has an honorary doctorate from the University of Athens, in recognition for his
lifetime contribution in immunology and medicine. He has also been awarded the
AESKU prize in Autoimmunity in 2008, in recognition of his lifetime contribution
in immunology. He is also fellow with the American Association for the
Advancement of Science. He is board-certified in internal medicine,
rheumatology, and allergy and clinical immunology, and currently serves as the
3
See generally exhibit 58 for a discussion of how antibodies to gangliosides (molecular
structures present on neurons)—such as GQ1b—mediate the course of GBS.
4
Ancillary reports from the experts addressing specific questions were also filed by both
petitioner and respondent.
3
editor-in-chief for the Journal of Autoimmunity, Autoimmunity Reviews, and
Clinical Reviews in Allergy. He has written or edited 68 books or monographs,
approximately 1,000 experimental research articles, 160 book chapters, and 200
review articles.
B. Dr. Penelope Morel, M.D.
Dr. Morel is a professor in the Department of Immunology at the University
of Pittsburgh, with a secondary appointment as a professor in the Department of
Medicine. She also serves as an affiliate member in the Center for Vaccine
Research. Dr. Morel received her undergraduate and medical degrees from the
University of Southampton in the United Kingdom. She obtained her doctor of
medicine in immunology from the University of Geneva in Switzerland. While she
performed clinical work early in her career, she no longer practices medicine and
does not hold any board certifications. Tr. 176. Dr. Morel has published
approximately 70 experimental research articles, and 40 non-experimental articles,
chapters, and reviews.
C. Evaluation
In considering the value of opinion testimony, special masters may consider
the offeror's expertise and weigh the opinion accordingly. Copenhaver v. Sec'y of
Health & Human Servs., No. 13-1002V, 2016 WL 3456436, at *7 (Fed. Cl. Spec.
Mstr. May 31, 2016), mot. for rev. denied, 129 Fed. Cl. 176 (2016). Beyond
expertise, special masters may make determinations as to the credibility of the
persons presenting opinion evidence. Moberly v. Sec'y of Health & Human Servs.,
592 F.3d 1315, 1326 (Fed. Cir. 2010).
While both experts provided helpful testimony, Dr. Gershwin’s testimony
was considerably more impressive. Dr. Gershwin’s testimony struck the
undersigned as being highly credible. He appeared confident in the opinions he
did express, but at the same time he was candid and forthright when stating the
limits of those opinions and the stochastic nature of topics being discussed. In
addition, Dr. Gershwin’s experience and expertise as both a physician and a
scientist allowed him to provide helpful insight into the questions at issue. Finally,
Dr. Gershwin’s scholarship is broad; few experts in the Vaccine Program have
written as prodigiously as he has. His expansive knowledge in the field of
autoimmunity gave substantial weight to his opinions.
4
Compared to Dr. Gershwin, Dr. Morel’s answers were often uncertain in
both tone and content. While Dr. Morel is medically trained, she has not treated
patients in some time and this lack of practical experience, accordingly, limited the
weight and scope of some of her opinions. While Dr. Morel’s scholarship is
impressive, the scope of her scholarship and reputability in the field of
immunology has not yet reached the level of Dr. Gershwin. This may very well
reflect that she is at an earlier stage of her career compared to Dr. Gershwin, but
that does not affect the ultimate impression that Dr. Gershwin’s opinion carries
with it more weight on topics in immunology.
III. Standards for Adjudication
Compensation under the Vaccine Act is available in two major forms. Table
injuries, which presume causation, can be established if a prescribed injury occurs
during a set period of time following a specific vaccination. 42 U.S.C. § 300aa-
11(c)(1)(C)(i). Alternatively, petitioners can receive compensation for injuries not
provided for in the Vaccine Injury Table by bringing a successful petition for
compensation under 42 U.S.C. § 300aa-11(c)(1)(C)(ii) of the Vaccine Act.
Here, Mr. Eamick does not claim that GBS constitutes a Table injury for
hepatitis A or B vaccine under the Vaccine Act. As an “off-Table Injury,” Mr.
Eamick must demonstrate that the vaccination caused his injury.
Petitioner’s burden of proof as an off-Table injury is explicitly defined by
Congress. The Act provides that a petitioner must show, by a preponderance of the
evidence, that the vaccination caused or significantly aggravated his illness or
injury. See 42 U.S.C. § 300aa–13(a)(1) and 42 U.S.C. § 300aa-11(c); see also
Moberly, 592 F.3d at 1322 (noting that petitioners must prove causation by the
traditional tort standard of preponderance). As for what is specifically required to
meet this burden, the statute requires that the conclusion of the court or special
master may not be “based on the claims of a petitioner alone, unsubstantiated by
medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1). The statute
does not speak to the strength or reputability of the medical opinion, just that a
medical opinion or medical records are necessary for a claim to be meritorious.
See id.
In drawing conclusions on causation, the Federal Circuit has noted that
special masters must be careful not to raise petitioners’ burden by establishing tests
that create requirements not in the statute itself. Capizzano v. Sec'y of Health &
Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006) (rejecting a test that required
5
“epidemiologic studies, rechallenge, the presence of pathological markers or
genetic disposition, or general acceptance in the scientific or medical
communities”); Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1279
(Fed. Cir. 2005) (rejecting a test requiring “confirmation of medical plausibility
from the medical community and literature” to prove causation in fact); Knudsen v.
Sec'y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994) (“to require
identification and proof of specific biological mechanisms would be inconsistent
with the purpose and nature of the vaccine compensation program”).
Instead, special masters must consider all the evidence and decide whether
the causal link between the vaccination and the injury was logical and legally
probable. See Knudsen, 35 F.3d at 549 (“The sole issues for the special master are,
based on the record evidence as a whole and the totality of the case, whether it has
been shown by a preponderance of the evidence that a vaccine caused the []
injury.”); Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed.
Cir. 1992) (“Causation in fact requires proof of a logical sequence of cause and
effect showing that the vaccination was the reason for the injury.”); Hines v. Sec'y
of Health & Human Servs., 940 F.2d 1518, 1525 (Fed. Cir. 1991) (“causation in
fact requires proof of a logical sequence of cause and effect showing that the
vaccination was the reason for the injury.”).
In determining whether preponderant evidence exists, the Federal Circuit has
set forth a three-part framework for evaluating claims of vaccine injury causation.
As explained in Althen, and subsequent opinions, petitioners must put forth: “(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.” Althen, 418 F.3d at 1278.
IV. Analysis
A. Althen Prong One: Petitioner’s Medical Theory.
Mr. Eamick does not need to prove with scientific certainty that the
vaccination he received can cause GBS. However, petitioners may not posit just
any theory of causation; the theory must be “reputable.” Althen, 418 F.3d at 1278(“A persuasive medical theory . . . being supported by reputable medical or
scientific explanation”) (internal citations omitted). What makes a theory
“reputable” is not exactly clear. In Hibbard, the Federal Circuit stated that
petitioner’s burden was to provide a “viable medical theory by which a vaccine can
cause the injury claimed by the petitioner.” Hibbard v. Sec'y of Health & Human
6
Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012). In contrast to mere “viability,” in
Moberly, the Federal Circuit required that the theory be “legally probable.”
Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir.
2010). Though the Federal Circuit has not spoken in unison about what exactly is
required from petitioners, based on the directives it has provided, it appears
accurate to say that petitioner’s medical theory linking the vaccination and the
injury must, at the least, be consistent with what is known about human biology.
Without a theory that passes that barrier, the Federal Circuit dictates that
compensation should be precluded. If the theory meets this minimum barrier to
entry, the special master should proceed to consider the other Althen elements to
make an ultimate conclusion on the question of whether predominant evidence
exists to find causation.
To understand the experts’ positions as it relates to Mr. Eamick’s case, a
brief review of Mr. Eamick’s condition and its etiology is useful. GBS is a
potentially life-threatening disease hallmarked by weakness in the extremities.
Exhibit E at 1. Some cases, as in Mr. Eamick’s, result in respiratory distress. Id.Scientists believe that GBS is autoimmune in nature and results from the body’s
immune system generating crossreactive antibodies formed in response to
pathogen-borne antigens. See id. at 1-4. These antibodies will then attack nerve
membranes, resulting in nerve damage or a loss of nerve conduction. Id. This
attack on the body’s own cells is referred to as a “loss of tolerance.”
As noted before, the creation of the cross-reactive antibodies is usually the
result of exposure to certain pathogens. Id. at 3. Some pathogens will result in
GBS more frequently than others. Id. Although the most common is
Campylobacter jejuni, a gastrointestinal infection, upper respiratory infections,
such as the infection that Mr. Eamick had, are another common culprit. Id.
It is not known why some URIs develop into GBS while most do not. Dr.
Gershwin cites from exhibit 51 (Hadden) for the proposition that the reason some
infections result in GBS is likely a function of how the body’s immune system
responds to the infection as opposed to features of the infection itself. Tr. 82.
Specifically, he references the authors’ statement that “[t]he pathogenesis is likely
to depend not only on the immunogenic components of the infecting organisms,
but also on the host's immune response." Id. (referencing exhibit 51 (R.D.M.
Hadden et al., Preceding Infections, Immune Factors, And Outcome In Guillain-
Barre Syndrome, 56 Neurology 758 (2001)) at 7). Importantly, Dr. Morel, agreed
with this proposition in her testimony. See Tr. 247-48.
7
Dr. Gershwin, in his reports and his testimony, provided a persuasive case
for how the hepatitis vaccines could dysregulate the host’s response to the URI
infection in a way that resulted in a breach of tolerance. Dr. Gershwin argued that
cytokines are already known to act as “amplifiers” that “facilitate antigen
presentation” by “augmenting . . . antibody production.” Tr. 76-77. This cytokine
response plays a necessary role in developing Mr. Eamick’s immune response to
the URI. A similar type of cytokine response happens as a result of all
vaccinations. Tr. 88. In Dr. Gershwin’s estimation, this cytokine response from
the vaccination can have non-specific effects. Specifically, it can, in conjunction
with the immune response to the URI, result in a loss of tolerance to endogenous
antigens through molecular imitation of the URI antigen. Tr. 85, 89. This
crossreactivity is what ultimately leads to GBS. Tr. 89.
The Secretary’s expert, Dr. Morel, attempted to rebut Dr. Gershwin’s theory
on three main grounds. First, she argues that the cytokine response to the vaccine
could not have interacted with the response to the URI since the cytokine response
to the vaccine is limited in space and does not result in a systemic cytokine
response. Tr. 188. Second, she argues that the epidemiological evidence does not
support causation. Third, she argues that there is no evidence in support of Dr.
Gershwin’s theory. Tr. 183-84. These critiques are addressed in turn.
Dr. Morel argues that “there would have to have been some evidence of
some widespread systemic response to the vaccine in order to really believe that
this response would have spilled over and caused further exacerbation of what was
already an immune response to a quite severe respiratory infection.” Tr. 189-90.
While Dr. Gershwin disagrees with Dr. Morel’s statement that the cytokine
reaction to the vaccine is not systemic, Tr. 91, he ultimately states that the issue of
the systematic nature of the immune response is moot. He argues that since the
lymph nodes where the cytokine response to the vaccine would occur are the same
as the lymph nodes where the immune response to the URI would occur, the two
responses have the opportunity to interact. Tr. 91-92. Dr. Morel does not
challenge that there is a strong cytokine response to the vaccine in the lymph
nodes, Tr. 190, and actually proffers exhibit HH to make that very point. See
exhibit FF at 2 (citing exhibit HH (Nikolaos Chatziandreou, Macrophage Death
following Influenza Vaccination Initiates the Inflammatory Response that
Promotes Dendritic Cell Function in the Draining Lymph Node, 18 Cell Reports
2427 (2017)) to establish that “the majority of the cytokines produced by cells of
the innate and adaptive immune system are confined to the lymph node”).
8
While Dr. Morel did introduce persuasive epidemiological studies showing
that there is not an association between hepatitis vaccines and GBS, those studies
do not appear to inform the present case. See exhibit B at 4 (citing, e.g., exhibit O
(Nizar Souayah et al., Analysis of Data from the CDC/FDA Vaccine Adverse
Event Reporting System (1990-2009) on Guillain-Barre Syndrome after Hepatitis
Vaccination in the USA, 19 J. Clinical Neuroscience 1089 (2012)) and exhibit U
(Penina Haber et al., Vaccines and Guillain-Barré Syndrome, 32 Drug Safety 309
(2009)). As noted above, Dr. Gershwin does not claim that the hepatitis vaccine
alone caused Mr. Eamick’s GBS to develop. Instead, Dr. Gershwin argues that the
vaccination explains why Mr. Eamick’s URI induced a loss of tolerance,
something that very few URIs do. An informative epidemiological study would
have to examine the effects of hepatitis vaccination on individuals suffering from a
URI (or perhaps other infections associated with GBS) to see if there were an
increased risk of developing GBS. According to both experts, these studies have
not been done and would be incredibly difficult to do given the sample size
required. Tr. 97, 211.
Dr. Morel also challenges Dr. Gershwin’s theory on the basis that there is a
lack of evidence linking hepatitis vaccinations with GBS. However, it appears that
she applies a burden that is in excess of the burden imagined by the Vaccine Act as
interpreted by the Federal Circuit. Towards the end of her testimony, Dr. Morel
summarized her opinion:
. . . there aren't any studies that have -- that describe the precise
sequence of events that Mr. Eamick went through. All we can say is
that, taken separately, we know that GBS is usually preceded by an
upper respiratory tract infection and that hepatitis A and B vaccines,
in general, do not cause that disease. So I think I'd just put those two
facts together, and that's how I came up with my opinion.
Tr. 243. This statement reflects the undersigned’s general impression that Dr.
Morel and Dr. Gershwin primarily disagree about the sufficiency of the evidence
necessary to draw their conclusions. As a physician and a scientist, Dr. Morel may
find the evidence here to be insufficient to conclude that the hepatitis vaccinations
can cause GBS under the right circumstances. However, the undersigned is not
tasked with determining if the hepatitis vaccinations can cause GBS with anything
approaching medical certainty. The only question is whether petitioner’s theory
meets the standards set forth by the Federal Circuit under Althen. On its face, Dr.
Gershwin’s theory is persuasive. Respondent has presented insufficient evidence
9
to undermine its reputability and thus Mr. Eamick has satisfied the first prong of
the Althen analysis.
B. Althen Prong Three: Temporal Relationship between the
Vaccination and the Injury.
Neither party focused on the issue of timing. Petitioner’s pre-hearing brief
dedicated a paragraph to the issue. See Pet’r’s Preh’g Br., filed June 13, 2017, at
22. Respondent’s brief dedicated two. See Resp’t’s Preh’g Br., filed July 13,
2017, at 17. However, the extent of respondent’s argument was to say that
petitioner did not sufficiently address the timing element. Id.
The limited time spent analyzing the question of timing is likely, in part,
attributable to the fact that both parties agree that the timing between Mr. Eamick’s
URI and the onset of his GBS was consistent with a causal link existing between
the two. Id. This fact is, in large part, the basis for the Secretary’s argument that
the URI completely accounts for Mr. Eamick’s GBS. See Tr. 183; see also exhibit
B at 3 (noting that the timing was appropriate).
However, as noted before, the point of disagreement between the parties is
whether the vaccination was also a substantial factor. See Shyface v. Secʼy of
Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999) (indicating that a
vaccination is the “legal cause” of an injury if the vaccination “is a ‘substantial
factor’ in bringing about the harm, and that the harm would not have occurred but
for the” vaccination). In his testimony, Dr. Gershwin points to the timing between
the vaccination and the onset of GBS as indicating a causal relationship between
the two.
To support this assertion, Dr. Gershwin explained that starting 24-48 hours
after antigen exposure, immunoglobulin (Ig) that has been exposed to the antigen
will begin to “class switch” from IgM to IgG. Tr. 100. This class switch would
peak seven to ten days following antigen presentation. Id. This change to IgG is
important because IgG can more easily pass through the blood brain barrier and
result in the type of pathology seen in GBS. Tr. 199. Because Mr. Eamick’s GBS
symptoms appeared one week following his vaccination, Dr. Gershwin argues that
this sequence is consistent with his medical theory that the cytokine response to the
hepatitis vaccine played a substantial role in the development of Mr. Eamick’s
GBS. Tr. 100. The respondent’s expert did not counter this argument.
Accordingly, the evidence in the record favors a finding that there was an
10
appropriately proximate temporal relationship between the vaccination and the
onset of Mr. Eamick’s GBS.
C. Althen Prong Two: Logical Sequence of Cause and Effect Showing
that the Vaccination was the Reason for Mr. Eamick’s GBS.
Evidence of a viable medical theory and temporal proximity between the
vaccination and the injury is strong evidence of causation. However, the Federal
Circuit has also said that such evidence is not enough. Althen, 418 F.3d at 1278(“[a]lthough probative, neither a mere showing of a proximate temporal
relationship between vaccination and injury, nor a simplistic elimination of other
potential causes of the injury suffices, without more, to meet the burden of
showing actual causation”). In Capizzano, the Federal Circuit further expounded
upon the importance of evaluating whether a logical sequence of cause and effect
exists independently of the timing analysis. Specifically, the Capizzano panel
stated “[t]here may well be a circumstance where it is found that a vaccine can
cause the injury at issue and where the injury was temporally proximate to the
vaccination, but it is illogical to conclude that the injury was actually caused by the
vaccine.” Capizzano, 440 F.3d at 1327. Thus, special masters must consider the
whole picture and determine, on the basis of all the evidence, if the purported
connection between the vaccination and the injury is logical. Examples of some of
the evidence that special masters may consider here include the opinions of
treating physicians and medical experts, evidence of rechallenge, epidemiological
studies, and the probability of coincidence or another cause. See id. The evidence
available to be weighed will, of course, depend on the facts of the case.
The parties did not present much evidence to be weighed under the second
Althen Prong. See Pet’r’s Preh’g Br., filed June 13, 2017, at 20-22; Resp’t’s
Preh’g Br., filed July 13, 2017, at 15-17. In large part, the focus of both
petitioner’s and respondent’s arguments under this prong of the analysis reverted to
an examination of the underlying medical theory as well as the temporal
relationship between the URI, the vaccinations, and the GBS. Id. These issues
have been reviewed above.
In addition, respondent points out that no treating physician associated Mr.
Eamick’s GBS to his vaccinations. Resp’t’s Preh’g Br., filed July 13, 2017, at 15;
Tr. 125. While this observation weighs against the conclusion that there exists a
logical connection between the vaccinations and the disease, the weight of this
evidence is not substantial. For one, as reviewed above, it is unknown why some
URIs trigger GBS and others do not. Accordingly, the physician would merely be
11
speculating and this lack of speculation in the medical records does not strike the
undersigned as particularly meaningful. Second, Dr. Gershwin’s opinion that the
association between Mr. Eamick’s vaccination and his development of GBS is
logical is given substantial weight. As noted before, Dr. Gershwin’s testimony was
particularly credible and his argument for the logical basis between the vaccination
and the injury was persuasive. See Section II.C.
D. Alternative Causation or Factor Unrelated
Even though Mr. Eamick has established his prima facie case under Althen,
the Secretary may still establish by preponderant evidence that his GBS is due to
factors unrelated to the vaccinations, thus precluding compensation. See
Deribeaux v. Sec'y of Health & Human Servs., 717 F.3d 1363, 1367 (Fed. Cir.
2013) (citing 42 U.S.C. § 300aa–13(a)(1)(B)). To do so, respondent must “provide
that proof by identifying a particular such factor (or factors) and presenting
sufficient evidence to establish that it was the sole substantial factor in bringing
about the injury.” Bazan v. Sec'y of Health & Human Servs., 539 F.3d 1347, 1354
(Fed. Cir. 2008).
Here, the Secretary argues that Mr. Eamick’s URI is the sole substantial
factor in bringing about his GBS and that this should preclude compensation.
Resp’t’s Preh’g Br., filed July 13, 2017, at 10, 16. In doing so, respondent cites to
Tompkins v. Sec'y of Health & Human Servs., No. 10-261V, 2013 WL 3498652(Fed. Cl. Spec. Mstr. June 21, 2013), mot. for rev. denied, 117 Fed. Cl. 713 (2014).
The respondent is correct in noting that the facts in Tompkins are quite similar to
the facts of Mr. Eamick’s case. Thus, it is not surprising that the respondent points
to Special Master Vowell’s conclusion that Mr. Tompkins’s preceding respiratory
infection was the cause of his GBS, precluding compensation. Id. at *1 (“I find
that his upper respiratory infection, which began two weeks prior to the onset of
his GBS symptoms, is a well-recognized cause of GBS, occurred at an appropriate
temporal interval before onset of symptoms, and is the most likely cause for
[petitioner’s] GBS”).
As a preliminary note, “[i]t is well-settled that special masters are neither
bound by their own decisions nor by cases from the Court of Federal Claims . . . .”
Rickett v. Sec'y of Health & Human Servs., 468 F. App'x 952, 959 (Fed. Cir. 2011)
(citing Hanlon v. Sec'y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998),
aff'd, 191 F.3d 1344 (Fed. Cir. 1999)). Furthermore, the Federal Circuit has
explicitly noted that special masters may very well come to different conclusions
based on the same set of facts. Lampe v. Sec'y of Health & Human Servs., 219
12
F.3d 1357, 1368 (Fed. Cir. 2000). But of course, the facts here, though similar, are
not identical. For example, Mr. Eamick relied upon a different expert — one that,
as stated in Section II, made a persuasive case in support of Mr. Eamick’s claim.
But, even more, Mr. Eamick did not rely on the same theory proffered by
Mr. Tompkins. As reviewed in Section IV.A, above, petitioner does not dispute
that the URI was necessary for Mr. Eamick’s GBS to develop. He does dispute,
however, that it was sufficient. Mr. Eamick supports this assertion by
demonstrating that the vast majority of URIs do not develop into GBS and that it is
currently believed that host factors, and not the preceding infection itself, are
critical in determining whether a URI will cause GBS. See exhibit 51 (Hadden) at
7. Dr. Gershwin proposes a cytokine response to hepatitis vaccination as
constituting this host factor in Mr. Eamick’s case and, for the reasons stated above,
this explanation appears persuasive. Based on the evidence in the record, it does
not appear that the respondent presents an alternate explanation for why Mr.
Eamick’s URI caused the onset of his GBS when the vast majority of URIs do not.
While it may be true that most cases of GBS are preceded by an infection, it is not
true that most infections are followed by GBS. Clearly, there is more to the story.
In this way, the absence of an alternate host factor that may have induced the onset
of GBS in Mr. Eamick’s case actually weighs in petitioner’s favor.
V. Conclusion
As the Federal Circuit has noted, cases in the Vaccine Program often have to
navigate an area of science bereft of certainty and absolutes. We, as a society, can
only hope to one day know why Mr. Eamick developed GBS, and a particularly
virulent form of the disease at that. Until that time, the Federal Circuit has stated
that compensation is appropriate when a petitioner can provide evidence of a
reputable medical theory attributing petitioner’s injury to the vaccination, evidence
of an appropriately proximate temporal relationship between the two, and evidence
that the causal association is logical. Mr. Eamick has met this standard and,
therefore, is entitled to compensation under the Vaccine Act.
An order regarding damages will be issued shortly.
s/ Christian J. Moran
Christian J. Moran
Special Master
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