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.

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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

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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.

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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

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“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.

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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”).

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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

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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

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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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