CHRISTIAN J. MORAN, Chief Special Master.
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").
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 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.
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.
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.
Mr. Eamick was hospitalized at the University of Missouri hospital for longer than two weeks.
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.
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).
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 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.
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.
In considering the value of opinion testimony, special masters may consider the offeror's expertise and weigh the opinion accordingly.
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.
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.
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.
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.
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.
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
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."
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.
As noted before, the creation of the cross-reactive antibodies is usually the result of exposure to certain pathogens.
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."
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.
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.
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:
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
Neither party focused on the issue of timing. Petitioner's pre-hearing brief dedicated a paragraph to the issue.
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.
However, as noted before, the point of disagreement between the parties is whether the vaccination was also a substantial factor.
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.
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.
The parties did not present much evidence to be weighed under the second
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 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.
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.
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
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. . . ."
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.
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.