McCollum v. Secretary of Health and Human Services ( 2018 )

United States Court of Federal Claims
No. 14-790 V
Filed Under Seal: December 21, 2017
Reissued: January 5, 20181
)
MICHAEL MCCOLLUM, )
)
Petitioner, )
) Vaccine case; Motion for Review;
v. ) Influenza Vaccine; Standard of Review;
) Althen; Burden of Proof; Motion for
SECRETARY OF HEALTH AND ) Review denied.
HUMAN SERVICES, )
)
Respondent. )
)
OPINION
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioners.
Alexis B. Babcock, Vaccine/Torts Branch, Civil Division, United States Department of Justice,
Washington, DC, for respondent.
SMITH, Senior Judge:
Petitioner, Michael McCollum, seeks review of a decision issued by Special Master Brian
H. Corcoran denying his petition for vaccine injury compensation. Petitioner brought this action
pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 et seq.
(2012), alleging that petitioner developed narcolepsy with cataplexy as a result of his receiving
the influenza vaccine in the fall of 2011. The Special Master denied compensation, finding that
petitioner’s narcolepsy with cataplexy was not caused by the vaccination. McCollum v. Sec’y of
Health & Human Servs., 2017 WL 5386613 (Fed. Cl. Spec. Mstr. Sept. 15, 2017) (McCollum).
Petitioner now moves for review of this decision. For the reasons that follow, the Court
DENIES his motion.
1
An unredacted version of this opinion was issued under seal on December 21, 2017. The
parties were given an opportunity to propose redactions, but no such proposals were made.
I. BACKGROUND
A brief recitation of the facts provides necessary context.2
Mr. McCollum’s medical history contains several pre-existing health conditions related
to the narcolepsy3 with cataplexy4 he alleges resulted from the influenza5 vaccine. These health
conditions include, but are not limited to, obstructive sleep apnea (“OSA”),6 smoking, attention
deficit/hyperactivity disorder, obesity,7 type II diabetes,8 severe hypertension,9 and chronic back
problems. The records obtained from Dr. Joseph C. Petrini, petitioner’s primary care physician,
include several documented incidents of general sleep related issues that predate the alleged
influenza vaccination. The incidents occurred sporadically from October 2009 to July 2011, and
they were typically referred to in general terms, such as “sleep disturbance,” “difficulty
sleeping,” “sleep problems,” “sleepiness,” and “still too fatigued to work.”
2
As the basic facts here have not changed significantly, the Court’s recitation of the
background facts here draws from the Special Master’s earlier opinion in McCollum.
3
Narcolepsy is defined as “recurrent, uncontrollable, brief episodes of sleep, often
associated with hypnagogic or hypnopompic hallucinations, cataplexy, and sleep paralysis.”
Dorland’s Illustrated Medical Dictionary at 1232 (32nd ed. 2012) (“Dorland’s”).
4
Cataplexy is defined as “a condition in which there are abrupt attacks of muscular weakness
and hypotonia triggered by an emotional stimulus such as mirth, anger, fear, or surprise. It is often
associated with narcolepsy.” Dorland’s at 303.
5
Influenza is defined as “an acute viral infection of the respiratory tract that may occur in
isolated cases, in epidemics, or in pandemics. . . . It is marked by inflammation of the nasal
mucosa, pharynx, and conjunctival; headache; myalgia; often fever, chills, and prostration; and
occasionally involvement of the myocardium or central nervous system.” Dorland’s at 937.
6
Sleep apnea is defined as “transient periods of cessation of breathing during sleep. It may
result in hypoxemia and vasoconstriction of pulmonary arterioles, producing pulmonary arterial
hypertension.” Obstructive sleep apnea is defined as “sleep apnea resulting from collapse or
obstruction of the airway with the inhibition of muscle tone that occurs during REM sleep.”
Dorland’s at 117.
7
Obesity is defined as “an increase in body weight beyond the limitation of skeletal and
physical requirement, as the result of an excessive accumulation of fat in the body.” Dorland’s at
1309.
8
Type II diabetes is defined as “one of the two major types of diabetes mellitus,
characterized by peak age of onset between 50 and 60 years, gradual onset with few symptoms of
metabolic disturbance, and no need for exogenous insulin.” Dorland’s at 506.
9
Hypertension is defined as “high arterial blood pressure.” Dorland’s at 896.
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In addition to preexisting sleep related issues, petitioner also experienced a number of
other medical issues similar to those complained of after the alleged vaccination. For example,
on July 10, 2010, petitioner was hospitalized for “an altered level of consciousness with
difficulty expressing himself and bilateral shaking of his arms,” at which point Mr. McCollum
reported that he fell asleep while riding in a car and “developed speech disturbance” earlier in the
day. Petitioner received an electroencephalogram (“EEG”)10 and an echocardiogram,11 both of
which showed normal results. The consulting neurologist, Dr. Gerald Wahl, concluded that the
petitioner’s clinical presentation was indicative of a transient ischemic attack (“TIA”),12 but that
the TIA could not account for bilateral arm shaking. The record next indicates a similar
occurrence after Mr. McCollum received his alleged influenza vaccination.
Petitioner was unable to provide direct proof establishing that he actually received the
influenza vaccine in October of 2011, instead attempting to prove that he received the vaccine
through circumstantial evidence. In doing so, petitioner relies on facts involving third parties.
Petitioner alleges that his wife, Linda McCollum, was admitted to Salinas Memorial emergency
room on September 24, 2011. Upon discharge, his wife received the influenza vaccine and was
advised that her family should follow suit. Mrs. McCollum asserts that she then told her husband
that he needed the vaccine, and petitioner claims he did so a few weeks later. Mr. McCollum
then alleges that he received the influenza vaccine from a Walgreens pharmacy near his home
around October 5, 2011. The Walgreens Company could not provide a record of the vaccination,
but was able to confirm that the H1N113 vaccine was being administered at stores across the
United States in the fall of 2011, and that the cost of the vaccination was $31.99 for uninsured
patients. Petitioner filed bank records for September and October 2011, which revealed that the
only purchase dated after Mrs. McCollum’s hospitalization that matched or surpassed the cost of
the vaccine in 2011 occurred on October 18, 2011.
Although Mr. McCollum’s medical records do not include any reference to possible early
signs of narcolepsy in the months immediately after the alleged vaccine, petitioner argues that he
was experiencing symptoms. At the hearing before the Special Master, he testified that the
symptoms began around December 2011, when he “would just drop [into sleep] like a stone.”
He also alleged that he would hallucinate while driving on the freeway and he would sit in front
of the television and suddenly wake up and realize he had dropped the cup that had been in his
10
An EEG is defined as “a recording of the potentials on the skull generated by currents
emanating spontaneously from nerve cells in the brain.” Dorland’s at 600.
11
Echocardiography is defined as “a method of graphically recording the position and motion
of the heart walls or the internal structures of the heart and neighboring tissue by the echo obtained
from beams of ultrasonic waves directed through the chest wall.” Dorland’s at 589.
12
A TIA is defined as “a brief attack of cerebral dysfunction of vascular origin, with no
persistent neurological deficit.” Dorland’s at 178.
13
H1N1 (otherwise known as “swine flu”) is defined as “an acute, highly contagious,
respiratory disease of hogs caused by a species of Influenzavirus A.” Dorland’s at 937.
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hand. Petitioner’s wife testified that petitioner began having symptoms of cataplexy in January
of 2012, and that petitioner felt cataplexy when he would become animated by telling jokes,
playing with his granddaughter, or when he received praise.
Petitioner visited the Community Hospital of the Monterey Peninsula emergency room
on January 29, 2012, complaining of weakness in his left leg, tingling on the left side of his face,
lightheadedness, and dizziness. His neurological examination and TIA workup were both
normal, and the treating physician concluded that petitioner’s sedative medications, Sorma and
Norco, which had previously been prescribed for his back pain, had likely contributed to his
symptoms. On January 30, 2012, petitioner visited Dr. Petrini, who indicated that his symptoms
could be neurological, and referred him to neurologist, Dr. Wayne Shen. Petitioner visited Dr.
Shen on February 7, 2012, at which point he reported that he was experiencing double vision,
hallucinations, the sudden onset of sleep on long drives, weakness and numbness in his leg, and
that he would get “a weird feeling on his face” when he laughed. He also complained of
constant sleepiness, increased sleeping generally, and sleep paralysis. Dr. Shen proposed several
differential diagnoses, including narcolepsy, and ordered a Multiple Sleep Latency Test
(“MSLT”).
Petitioner alleges that his cataplexy worsened by mid-February. He returned to Dr. Shen
on March 1, 2012, reporting worsening symptoms, including “[s]leep dreaming and waking up.”
At that point the MSLT results came back, Dr. Shen indicated that a diagnosis of narcolepsy with
“near cataplexy” was appropriate, and Dr. Shen referred petitioner to Dr. June Seliber-Klein, a
neurologist/sleep specialist at the June Klein Practice in Monterey, California, for further
evaluation. Mr. McCollum had an initial evaluation with Dr. Klein on April 16, 2012, but, as
Mr. McCollum never returned for a follow-up visit, those records are inconclusive.
On June 20, 2012, petitioner visited the Stanford Sleep Medicine Clinic and was seen by
Drs. Vikas Jain and Emmanual Mignot. They conducted a diagnostic polysomnogram,14 and
diagnosed petitioner with “hypersomnia15 with sleep apnea (unspecified),” which is a condition
characterized by excessive daytime sleepiness but distinct from narcolepsy. The doctors then
took a blood sample to test for the Human Leucocyte Antigen,16 a gene that predisposes
individuals to narcolepsy, but which is also common in the general population without
narcolepsy. Mr. McCollum tested positive for the gene, and the doctors ultimately revised his
14
Polysomnography is defined as “the polygraphic recording during sleep of multiple
physiologic variables, both directly and indirectly related to the state and stages of sleep, to assess
possible biological causes of sleep disorders.” Dorland’s at 1494.
15
Hypersomnia is defined as “excessive sleeping or sleepiness, as in any of a group of sleep
disorders with a variety of physical and psychogenic causes.” Dorland’s at 896.
16
The Human Leucocyte Antigen is defined as “histocompatibility antigens governed by
genes of the HLA complex, a region on the short arm of chromosome 6 containing several genetic
loci, each having multiple alleles.” Dorland’s at 105.
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diagnosis to include narcolepsy and cataplexy after he completed a sleep study, during which he
exhibited hypoventilation,17 low oxygen saturations,18 and OSA.
Petitioner continued to participate in sleep studies and visit the Stanford Sleep Medicine
Clinic from August 2012 through April 2013. He was heavily medicated to counteract his
symptoms, but continued to report “rather significant cataplexy.” His medication was eventually
increased and he was able to return to work on May 10, 2013.
Petitioner filed his vaccine petition on August 29, 2014, pursuant to the Vaccine Act.
Petitioner filed the expert report and curriculum vitae of Dr. Marcel Kinsbourne,19 a neurologist,
on September 15, 2015. Respondent filed an expert report from Dr. Maryanne Deak,20 who
specializes in sleep disorders, on June 13, 2016. An entitlement hearing was held in
Washington, DC on April 4, 2017. On September 15, 2017, Special Master Corcoran issued a
17
Hypoventilation is defined as “a state in which there is a reduced amount of air entering
the pulmonary alveoli, resulting in increased carbon dioxide tension.” Dorland’s at 908.
18
Oxygen saturations are defined as “a measure of the degree to which oxygen is bound to
the hemoglobin, usually measured by a pulse oximeter, given as a percentage calculated by
dividing the maximum oxygen capacity into the actual oxygen content and multiplying by 100.”
Dorland’s at 1670.
19
Dr. Kinsbourne received his medical degree in England, has been licensed to practice
medicine in North Carolina since 1967, and is board-certified in pediatrics. See Dr. Kinsbourne
Curriculum Vitae, Ex. 14 (ECF No. 21) (hereinafter “Kinsbourne CV”), at 1. From 1967 to 1974,
Dr. Kinsbourne served as an associate professor in pediatrics and neurology and as a senior
research associate at Duke University Medical Center. Id. at 2. He then held a series of academic
positions. Id. His clinical experience includes serving as a senior staff physician in Ontario from
1974-1980, and serving as a clinical associate in neurology at Massachusetts General Hospital
from 1981-1991. Id. He does not have any specific expertise in narcolepsy, nor has he studied or
researched in immunologic issues raised by theories claiming vaccine causation.
20
Dr. Deak graduated from Georgetown University School of Medicine in 2004, and she is
a board-certified neurologist and sleep specialist currently employed at eviCore healthcare, where
she works on guideline development and clinical case review for sleep medicine or neurology
cases. See generally Dr. Deak Curriculum Vitae, Ex. B (ECF No. 32) (hereinafter “Deak CV”);
Transcript of Proceedings (hereinafter “Tr.”) at 130-32. Dr. Deak completed residencies at both
New York University and University of Massachusetts. Deak CV at 1. She served as a clinical
and research fellow in sleep medicine at Brigham and Women’s Hospital at Harvard Medical
School. Id. She then became an instructor at the same hospital in the Division of Sleep Medicine
in the Department of Internal Medicine. Id. She often works with patients being evaluated for
narcolepsy, and she has helped develop a stimulant medicine for patients with narcolepsy and
central hypersomnia. Id. at 8. She has written or coauthored several peer reviewed articles and
book chapters in the area of sleep disorders. Id. at 8-10.
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decision denying petitioner’s claim and finding that petitioner was not entitled to compensation
because he failed to establish a reliable causation theory.
On October 5, 2017, petitioner filed a Motion for Reconsideration, alleging that a new
“retrospective review21 from 20 premiere pediatric sleep centers in the United States. . .found ‘a
significant increase in the number of childhood narcolepsy cases with seasonal pattern after the
2009 H1N1 pandemics in the United States.’” Petitioner’s Motion for Reconsideration at 1; see
also Simakajornboon, et al. On October 12, 2017, Special Master Corcoran denied petitioner’s
Motion for Review, finding that the abstract review petitioner provided “says too little about [the
H1N1 vaccine’s association with narcolepsy] for me to conclude that it changes the balance of
evidence in Petitioner’s favor.” Order Denying Motion for Reconsideration at 5.
On October 16, 2017, petitioner filed his Motion for Review (hereinafter “MFR”) of the
Special Master’s decision. Respondent filed a response to petitioner’s Motion for Review
(hereinafter “Resp. to MFR”) on November 15, 2017. The Court held Oral Argument on
December 19, 2017, and the Motion for Review is now ripe for decision.
II. DISCUSSION
Under the Vaccine Act, this Court may review a special master’s decision upon the
timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)-(2). In that instance, the Court
may: “(A) uphold the findings of fact and conclusions of law. . ., (B) set aside any findings of
fact or conclusion of law. . .found to be arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with law. . ., or, (C) remand the petition to the special master for further action
in accordance with the court’s direction.” Id. at § 300aa-12(e)(2)(A)-(C). Findings of fact and
discretionary rulings are reviewed under an “arbitrary and capricious” standard, while legal
conclusions are reviewed de novo. Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870
n. 10 (Fed. Cir. 1992); see also Doyle ex rel. Doyle v. Sec’y of Health & Human Servs., 92 Fed.
Cl. 1, 5 (2010).
Althen v. Secretary of Health & Human Services provides the evidentiary burden for
petitioners attempting to succeed in a vaccine petition based on causation. See generally Althen
v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). In order to prove causation-
in-fact, a petitioner must
show by preponderant evidence that the vaccination brought about [petitioner’s]
injury by providing: (1) a medical theory causally connecting the vaccination and
the injury; (2) a logical sequence of cause and effect showing that the vaccination
21
M. Simakajornboon, et al., Increased Cases of Childhood Narcolepsy After the 2009 H1N1
Pandemics: Preliminary Data from the Pediatric Working Group of the Sleep Research Network,
40 Sleep A337 (2017) (hereinafter “Simakajornboon, et al.”).
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was the reason for the injury; and (3) a showing of a proximate temporal
relationship between vaccination and injury.
Id. at 1278. In order to succeed, petitioners must provide a “reputable medical or scientific
explanation” for their claim. Id.
Within this framework, petitioner makes two numbered objections to the September 15,
2017 decision. See MFR at 1. First, petitioner asserts that the Special Master acted arbitrarily in
ignoring evidence of a challenge-rechallenge in Petitioner. Id. Second, petitioner argues that the
Special Master erred as a matter of law by increasing Petitioner’s burden of proof supporting a
medically-plausible theory of causation in support of Althen prong one. Id.
A. Challenge-Rechallenge
In his Motion for Review, petitioner alleges that the Special Master acted arbitrarily in
ignoring evidence of petitioner’s challenge-rechallenge response. MFR at 16. A challenge-
rechallenge occurs “when a patient who had an adverse reaction to a vaccine suffers worsened
symptoms after an additional injection of the vaccine.” Capizzano v. Sec’y of Health and Human
Servs., 440 F.3d 1317, 1322 (Fed. Cir. 2006). In making this argument, petitioner alleges that,
because his symptoms worsened after receiving an alleged second vaccination, the Special
Master should have considered that to be “unassailable evidence that the vaccine did, in fact,
cause the injury at issue.” Id. (emphasis in original). This Court does not agree with petitioner’s
argument.
As an initial matter, petitioner has failed to provide any direct evidence he ever received
the initial vaccine at issue, let alone the second vaccine which would have triggered the
challenge-rechallenge response. The Special Master appears to accept petitioner’s evidence,
which is circumstantial at best, as proof that petitioner actually received the influenza vaccine in
October of 2011. Mr. and Mrs. McCollum both testified that petitioner received a second
influenza vaccination in October of 2012 while undergoing treatment at the Stanford Sleep
Medicine Clinic. The Special Master acknowledged this by stating in his decision that petitioner
testified that “his physicians requested (contrary to the theory proposed herein relating the
vaccine to the claimed illness) that he receive an additional flu shot, and that he did so in
October 2012, although (like the vaccination at issue in this case) there is no formal record of it.”
Decision Denying Entitlement (hereinafter “Dec.”) at 8 (emphasis in original). As there is no
direct evidence that the second vaccine was ever received, petitioner’s argument that “[t]he
evidence regarding the second vaccination is clear and unrebutted,” is misleading and
uncorroborated. Even if there was evidence in the record of the second vaccine, the medical
records from the Stanford Sleep Medicine Clinic did not attach any significance to the
petitioner’s alleged increase in vivid dreams that purportedly occurred following the second
vaccine. See Petitioner’s Exhibit (hereinafter “Pet. Ex.”) 6 at 116-19.
Secondly, petitioner is attempting to argue that the Special Master should have
considered the challenge-rechallenge response as proof that the purported influenza vaccine
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caused his narcolepsy, despite the fact that petitioner never made any challenge-rechallenge
argument in the proceedings below. Vaccine Rule 8(f) provides that “[a]ny fact or argument not
raised specifically in the record before the special master will be considered waived and cannot
be raised by either party on review of the special master’s decision.” Rules of the Court of
Federal Claims (hereinafter “RCFC”), Appendix B, Rule 8(f). Petitioner never raised the
challenge-rechallenge issue during the proceedings before the Special Master, either in the expert
testimony or during trial testimony. See generally Pet. Ex. 13, 41. The Special Master cannot be
expected to, sua sponte, apply a legal theory that petitioner did not himself raise. To ask the
Special Master do so would be to shift the burden of proof from the petitioner to the Special
Master himself. As such, petitioner’s challenge-rechallenge issue has been waived.
In addition to asserting that the Special Master’s actions were arbitrary, petitioner asks
this Court to forego a remand as petitioner believes “[t]he evidence on this point is explicit
enough to justify this Court reach an independent conclusion that petitioner has presented
sufficient proof of liability and is entitled to compensation.” MFR at 18. Findings of fact and
discretionary rulings are reviewed under an “arbitrary and capricious” standard. Munn, 970 F.2d
at 870 n.10; see also Doyle ex rel. Doyle, 92 Fed. Cl. at 5. This Court will not presume to review
this case, de novo, in order to make unsupportable findings of fact that further a legal theory that
was previously waived by petitioner.
B. Althen Prong One
In addition to arguing that the Special Master ignored evidence of a challenge-
rechallenge response, petitioner also asserts that the Special Master erred as a matter of law by
increasing petitioner’s burden of proof supporting a medically plausible theory of causation in
support of Althen prong one. Petitioner concludes his argument by stating that he has provided
“a medically plausible theory, accepted by top researchers in the field, and therefore, [has
satisfied] Althen prong one.” MFR at 24 (emphasis added). Essentially, petitioner is asking this
Court to set aside Federal Circuit precedent in favor of the less stringent standard as set forth in
Contreras v. Sec’y of Health & Human Servs. 121 Fed. Cl. 230, 245 (2015). This Court rejects
the application of the Contreras standard in this case.
This Court is constrained by the Federal Circuit’s decision in Moberly v. Sec’y of Health
& Human Servs, which held that “[a]lthough a Vaccine Act claimant is not required to present
proof of causation to the level of scientific certainty, the special master is entitled to require
some indicia of reliability to support the assertion of the expert witness.” 592 F.3d 1315, 1324
(Fed. Cir. 2010). Althen requires that petitioners must provide a “reputable medical or scientific
explanation” for their claim. Althen, 418 F.3d at 1278. “The determination of whether a
proffered theory of causation is ‘reputable’ may ‘involve an assessment of the relevant scientific
data.’” Hazlehurst ex rel. Hazlehurst v. Sec’y of Health & Human Servs., 88 Fed. Cl. 473, 479
(2009) (quoting Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir.
2009)). Furthermore, “‘reversible error will be extremely difficult to demonstrate’ where the
special master ‘has considered the relevant evidence of record, drawn plausible inferences and
articulated a rational basis for the decision.’” Porter v. Sec’y of Health & Human Servs.,
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663F.3d 1242, 1253-54 (quoting Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528
(Fed. Cir. 1991)); see also Lombardi v. Sec’y of Health & Human Servs., 656 F.3d at 1343, 1353
(Fed. Cir. 2010). Such is the case here.
Here, the Special Master evaluated the petitioner’s medical records in conjunction with
the expert reports and testimony and found that petitioner had not met his burden under Althen
prong one. Petitioner argues that “the study from China22 has been considered sufficiently
reliable by experts in the field to prompt the investment of considerable resources into related
research.” MFR at 21. He also asserts that “world class researchers. . .have readily accepted the
Chinese study as evidence of a link between H1N1 virus and narcolespy [sic].” Id. at 20.
Petitioner further cites to a study23 on the association between the influenza vaccine, Pandemrix,
and narcolepsy as probative of a causal link between the two. Id. at 21.
As the Special Master pointed out, “[t]here is an immediate facial limitation, however, to
the application of such literature to this case. Pandemrix is not a form of the flu vaccine
administered in the U.S.”24 Dec. at 11 (emphasis in original). Petitioner’s legal theory is belied
in three ways. First, the studies provided deal with the adjuvanted25 monovalent26 version of the
H1N1 vaccine, while the vaccine administered in the United States was unadjuvanted. Second, a
subsequent article27 of a similarly-adjuvanted vaccine in Canada observed no similar association
between the adjuvanted vaccine and narcolepsy, which suggests the correlation may be specific
to Pandemrix. Third, to date, there is no evidence that the vaccine administered in the United
States is liked to an increased risk of narcolepsy, and, in fact, the only epidemiological study28
22
Fang Han, et al., Narcolepsy Onset is Seasonal and Increased Following the 2009 H1N1
Pandemic in China, 70 Am. Neurological Ass’n 410, 410-17 (2011).
23
Elizabeth Miller, et al., Risk of Narcolepsy in Children and Yong People Receiving AS03
Adjuvanted Pandemic A/H1N1 Influenza Vaccine: Retrospective Analysis, Brit. Med. 346, 794
(2014).
24
Narcolepsy Following Pandemrix Influenza Vaccination in Europe, CDC,
https://www.cdc.gov/vaccinesafety/concerns/history/narcolepsy-flu.html (last visited December
20, 2017).
25
Adjuvant is defined as “assisting or aiding; a substance that aids another, such as an
auxiliary remedy; in immunology, a nonspecific stimulator of the immune response.” Dorland’s
at 32.
26
Monovalent is defined as “having a valence of one; denoting an antiserum, vaccine, or
antitoxin specific for a single antigen or organism.” Dorland’s at 1179.
27
S. Sohail Ahmed, et al., Narcolepsy, 2009 A(H1N1) Pandemic Influenza, and Pandemic
Influenza Vaccinations: What is Known and Unknown About the Neurological Disorder, the Role
for Autoimmunity, and Vaccine Adjuvants, 50 J. Autoimmunity 1, 7 (2014).
28
Johnathan Duffy, et al., Narcolepsy and Influenza A (H1N1) Pandemic 2009 Vaccination
in the United States, 83 Neurology 1823, 1823-30 (2014).
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that dealt with the H1N1 vaccine in the United States found that there was no causal connection
between the vaccine and narcolepsy. The Special Master clearly considered the expert reports
and testimony proffered by both the petitioner and the respondent, and he came to the conclusion
that petitioner failed to provide a “‘reputable medical or scientific explanation’ for [his] claim.”
See Althen, 418 F.3d at 1278; see generally Dec. at 8-15. The Special Master has clearly
“considered the relevant evidence of record, drawn plausible inferences and articulated a rational
basis for the decision.” Hines, 940 F.2d at 1528. As such, he in no way elevated petitioner’s
burden of proof in regard to Althen prong one.
III. CONCLUSION
This Court finds that petitioner has not met his burden of proof in alleging that his
influenza vaccine resulted in his narcolepsy and cataplexy. For the foregoing reasons, the Court
DENIES petitioner’s Motion for Review.29
IT IS SO ORDERED.
s/ Loren A. Smith
Loren A. Smith,
Senior Judge
29
This opinion shall be unsealed, as issued, after January 4, 2018, unless the parties, pursuant
to Vaccine Rule 18(b), identify protected and/or privileged materials subject to redaction prior to
that date. Said materials shall be identified with specificity, both in terms of the language to be
redacted and the reasons therefor.
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