Garrison v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-762V
Filed: October 29, 2015
(Not to be published)
*************************
KRISTINA GARRISON, *
*
Petitioner, * Ruling on Record; Trivalent Influenza
v. * Vaccine; Narcolepsy; Cataplexy;
* Hypocretin.
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*************************
Curtis R. Webb, Twin Falls, ID, for petitioner.
Ryan D. Pyles, United States Department of Justice, Washington, DC for respondent.
RULING ON ENTITLEMENT1
Gowen, Special Master:
On August 22, 2014, Kristina Garrison (“petitioner” or “Ms. Garrison”) filed a petition
pursuant to the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-1 et seq. (2006)
(“Vaccine Act”). Petitioner alleges that as a result of receiving a trivalent influenza (“flu”)
vaccination on October 28, 2011, she developed narcolepsy and cataplexy. See Petition at ¶ 1, 2,
docket no. 1, filed Aug. 22, 2014. Petitioner also alleges that she has, and will continue to suffer,
effects of her narcolepsy and cataplexy. Id. at ¶ 16. In support of her petition, petitioner filed
several medical records; treatment records and medical literature from a narcolepsy expert, Dr.
Emmanuel Mignot; an expert opinion from Dr. Marcel Kinsborne; and several pieces of medical
literature in support of causation.
1
Because this unpublished decision contains a reasoned explanation for the action in this case, the
undersigned intends to post this decision on the United States Court of Federal Claims’ website,
in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899,
2913 (codified as amended at 44 U.S.C. § 3501 and note (2006)). In accordance with Vaccine
Rule 18(b), a party has 14 days to identify and move to delete medical or other information, that
satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the rule requirement, a motion
for redaction must include a proposed redacted decision. If, upon review, the undersigned agrees
that the identified material fits within the requirements of that provision, such material will be
deleted from public access.
1
On August 2, 2015, respondent filed a Rule 4(c) Report and a motion for a ruling on the
record, stating that while she “agrees that petitioner’s appropriate diagnosis is narcolepsy with
cataplexy,” she “concludes that there is insufficient scientific evidence to support a causal
relationship between the influenza vaccine and narcolepsy (with or without cataplexy).”
Respondent’s Report (“Res. Report”) at 4, docket no. 21, filed Apr. 2, 2015. Nevertheless,
although she recommends against compensation in this case, she “will not expend further resources
to contest entitlement in this matter.” Id. Respondent moved for a decision on entitlement based
on the record. Id.
Based on a review of the entire record, the undersigned finds that petitioner is entitled to
compensation.
I. BACKGROUND
A. Procedural History
Along with the petition, petitioner filed twenty-seven exhibits of medical records, an
affidavit, and medical literature in support of her petition. See Petitioner’s Exhibits (“Pet. Ex(s).”)
1-27. An initial status conference was held on September 17, 2014, after which petitioner was
ordered to file a Statement of Completion and an expert report addressing the Althen2 factors. See
Order, docket no. 12, filed Sept. 23, 2015. Petitioner filed a Statement of Completion on September
29, 2014. On February 2, 2015, petitioner filed an expert report by Dr. Marcel Kinsbourne and
several additional exhibits of medical literature. See Pet. Ex. 28-50. Thereafter, respondent was
ordered to file a responsive expert report and Rule 4(c) report by April 3, 2015. On April 2, 2015,
respondent filed a Rule 4(c) Report indicating that she did not intend to defend this case, and so
moved for a ruling on the record. Res. Repot at 4. Respondent did not file a responsive expert
report. This matter is now ripe for a decision.
B. Factual History
Petitioner received a flu vaccination at thirty-eight years old on November 9, 2011.3 Pet.
Ex. 4 at 2-3. At that time, petitioner was employed as a Branch Manager at U.S. Bank in Buhl,
Idaho, and was married with four children. Pet. Ex. 1 at ¶ 2. In mid-November 2011 petitioner
began experiencing excessive daytime sleepiness. Id. at ¶ 5. She noted in her affidavit that around
this time, she would become sleepy while interviewing candidates for positions at the bank. Id. In
early December 2011, she experienced her first episode of suddenly falling asleep. She fell asleep
on the toilet in a bathroom at work. Id. at ¶ 7. When she roused from that episode, she could not
remember falling asleep. Id. Also in December 2011, she began to experience sudden collapses,
triggered by any strong emotion, which was often stress. Id. at ¶ 8.
A week prior to January 25, 2012, petitioner called her primary care doctor, Dr. Jennifer
Preucil, reporting fatigue and feeling “like she was crashing over the last 3 months.” Pet. Ex. 5 at
2
Althen v. Sec=y, HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005).
3
The petition alleges receipt of the flu vaccine on October 28, 2011, however, the medical records
indicate that she signed a consent form on that date, and received the vaccine on November 9,
2011.
2
19. Dr. Preucil ordered lab testing. Id. At the January 25, 2012 appointment with Dr. Preucil, the
doctor noted petitioner’s history of a uterine infection following a surgery in October 2010, and a
history of hypoglycemia. Id. Petitioner’s lab tests revealed elevated liver enzymes. She was
referred to a gastroenterologist. Pet. Ex. 5 at 20. Dr. Preucil’s records also noted that petitioner
reported a twenty pound weight gain as a result of not exercising due to her fatigue. Id. at 19.
Petitioner reported no depression or emotional distress. Id.
Petitioner visited gastroenterologist, Dr. Seth Wheeler, on March 12 and 19, 2012, for a
chronic history of elevated AST with a history of Hellp Syndrome4 with each pregnancy. Id. at 23.
Dr. Wheeler noted fatigue in his assessment of petitioner. Id. at 25. Dr. Wheeler noted that her
likely diagnosis was nonalcoholic steatohepatitis,5 as “this is the most common source of LFT
elevations when other etiologies [are] ruled out.” Id. at 28.
Petitioner’s excessive daytime fatigue and sleepiness continued and became progressively
severe in the subsequent months. Pet. Ex. 1 at ¶ 10. She would fall asleep at work, she could not
remember conversations she had, and she was unable to concentrate at work. Id. On May 17, 2012,
she sought treatment from Dr. Dan Nofzinger, who recommended a liver biopsy. Pet. Ex. 7 at 2.
Petitioner’s liver biopsy showed minimal chronic hepatitis. Pet. Ex. 5 at 53. On June 8, 2012, Dr.
Nofzinger ordered an EEG. Id. The EEG was unusual, so the doctor ordered a sleep study. Pet. Ex.
1 at ¶ 12. Based on the sleep study, Dr. Nofzinger diagnosed petitioner with narcolepsy and
prescribed her Provigil. Pet. Ex. 7 at 2-3. The doctor’s July 18, 2012 medical records noted that
due to petitioner’s episodes of falling asleep at work, she was required to take a leave of absence.
Id. at 2.
On September 21, 2012, Dr. Nofzinger noted that petitioner’s narcolepsy was not well
controlled with Provigil. Id. at 3. He documented that “within the last month she [] had episodes
of falling asleep[,] once while waiting on a customer and once while driving.” Id. On October 1,
2012, Dr. Nofzinger referred petitioner to neurologist, Dr. Richard Hammond. Id. Petitioner visited
Dr. Hammond on December 27, 2012, who noted that petitioner experienced decreased awareness
since December 2011. Pet. Ex. 5 at 3. Petitioner reported to Dr. Hammond that her narcolepsy
“was usually preceded by a very odd sensation that would come up the back of her neck,” followed
by lessened awareness. Id. She reported that if she could take a ten to twenty minute nap while at
work during the day, it would enable her to be alert for hours afterwards. Id. She also reported that
she could sleep up to fifteen hours a day. Id. Additionally, there were episodes where she would
fall to ground but would not fall asleep, “her knees would just buckle and she would fall.” Id. She
preferred to treat her condition with regular napping, as her medications caused her terrible side
effects. Id. at 3, 5-6; Pet. Ex. 1 at ¶ 14-16. An MRI of her brain was normal. Pet. Ex. at 5. Dr.
Hammond confirmed her diagnosis of narcolepsy with cataplexy, prescribed Effexor for her
cataplexy, and Nuvigil for her narcolepsy. Id. at 5-6, 8.
On a June 11, 2013 visit to Dr. Hammond, the doctor noted that petitioner’s Nuvigil was
stopped a week prior because it failed to improve her condition and caused her to become moody
4
A condition of hemolysis, elevated liver enzymes, and low platelet count. See Neil M. Davis,
Medical Abbreviations 155 (15th ed. 2011).
5
A liver disease characterized by a fatty liver with inflammation. See Dorland’s Medical
Illustrated Dictionary 1768 (32d ed. 2012).
3
and hallucinate. Id. at 10. Dr. Hammond documented that her narcolepsy and cataplexy had
become “quite profound[,] and she had multiple falls during the day.” Id. “It did not take hardly
any emotion at all to push her over the edge of having a cataplectic attack.” Id. Petitioner’s
performance at work continued to suffer as a result of her condition. Id.; Pet. Ex. 1 at ¶ 18. She
frequently fell asleep at work, sometimes while with a customer. Pet. Ex. 1 at ¶ 18. In May 2013,
she was asked to take a paid leave of absence to pursue more effective treatment for her condition.
Id. at ¶ 21. In June 2013, Dr. Hammond tried treating her with Pristiq to improve her cataplexy
and also decreased her dose of Nuvigil. Pet. Ex. 5 at 10. Also during this visit, Dr. Hammond noted
that he will complete her disability forms because she could not work. Id. at 10-11. Up until that
point, petitioner had been an employee at U.S. bank for thirteen years. Pet. Ex. 1 at ¶ 19.
On August 9, 2013, petitioner had a follow-up visit with Dr. Hammond. See Pet. Ex. 5 at
12. Dr. Hammond noted that petitioner was being treated with Pristiq and Nuvigil, which enabled
her to better stay awake during the day and had reduced the frequency of her cataplexy.” Id. The
medical record noted that petitioner was in good spirits and in no distress during that visit, but that
she would become tearful when talking about work. Id. Dr. Hammond recommended that she not
return to work, as she still became sleepy if she sat down for a lengthy period of time. Id. The
doctor also noted that he would like to treat petitioner with a prescription of Xyrem, however there
was difficulty with insurance approval of the medication. Id.
On a follow-up visit with Dr. Hammond on October 4, 2013, petitioner reported that she
became paralyzed for about eight minutes in a cataplectic event after experiencing anger. Pet. Ex.
5 at 14. She could only move her eyes during that episode. Id. Petitioner reported that she had
missed her dose of Pristiq the day before. Id. She reported that she still had episodes of “significant
sleep attacks” with a frequency of about one a day. Id. Whenever she sat down, she would fall
asleep. Id. She stopped driving for fear of falling asleep. Id. Dr. Hammond noted continued
difficulty with insurance approval of petitioner’s medications. Id.
On November 20, 2013, petitioner saw a neurologist and sleep specialist, Dr. Emmanuel
Mignot at Stanford Medical Center. Pet. Ex. 8 at 3-7. Dr. Mignot is a board certified sleep
Specialist and expert in narcolepsy. Id. at 20. He has been the director of the Center for Narcolepsy
at Stanford University for over nineteen years, and a director of the Stanford Sleep Division in the
Psychiatry Department. Id. Dr. Mignot noted that petitioner received an influenza vaccination and
developed excessive daytime sleepiness and sleep attacks, followed by cataplexy with knee
buckling. Id. at 2.6 Dr. Mignot noted that petitioner was still having “excessive daytime
sleepiness,” and that her sleep attack and cataplexy were not under control yet. Id. at 5. He
documented that petitioner had a forty-five pound weight gain since 2010 and dysmenorrhea. Id.
at 2. He also noted petitioner’s “difficulty organizing, planning, and making judgment,” and that
she had disrupted nighttime sleep. Id. Dr. Mignot recommended treatment with Xyrem, as it was
the “most effective medication for narcolepsy with cataplexy . . . .” Id. at 5. The doctor believed
the medication provided “a good chance for [petitioner] to regain her function.” Id.
6
In his records, Dr. Mignot incorrectly documented petitioner’s vaccination date and onset of
symptoms. Notwithstanding this error, the undersigned finds his medical records are otherwise
reliable and credible.
4
On December 13, 2013, petitioner reported improvement of her condition with Xyrem. Pet.
Ex. 8 at 17. On December 17, 2013, it was noted that she had started Xyrem two weeks prior. As
a result of that medication, her cataplexy was “considerably better,” she was no longer
experiencing the frequent “zingers” associated with her cataplexy, and that she was feeling less
sleepy during the day. Id. Dr. Mignot recommended that she increase her dose of Xyrem from 2.5
grams to 3.0 grams. Id.
On January 9, 2014, Dr. Mignot wrote to petitioner’s insurance carrier, Blue Cross Blue
Shield, in support of her appeal of the decision to deny coverage of Xyrem. Pet. Ex. 8 at 20-25.
Dr. Mignot wrote that “[petitioner] first developed symptoms of narcolepsy in January of 2011
[sic] after flu vaccination in December of 2010 [sic].” Id. at 20. He summarized her subsequent
medical history and noted that she had been unable to work since May 6, 2013 “due to the lack of
adequate control of cataplexy and continued daytime sleepiness.” Id. at 21. He noted that her
current prescriptions, Ritalin, Provigil, Effexor, and Pristiq did not adequately control her
condition, and caused side effects like headaches, negative personality effects, and severe mood
swings. Id. He wrote that petitioner had been able to receive Xyrem through a voucher program
for patients who are unable to get coverage, however the voucher only provided a short trial. Id.
He advocated for her appeal, noting that her symptoms “have improved considerably” on Xyrem,
and that “Xyrem is the only approved medication for the purpose of treating cataplexy.” Id.
Dr. Mignot also wrote a letter to the employee benefits analyst at the Minneapolis Claims
Office on January 9, 2014 to request an extension of petitioner’s short term disability benefits. Pet.
Ex. 8 at 23. He wrote that “we are confident that with the proper medication and minor
accommodations, [] Ms. Garrison will be able to return to full time employment. Id. He reported
that the persistent symptoms which make it difficult for her to go back to work include: slurred
words and the inability to communicate due to cataplexy, the inability to drive due to cataplexy,
daytime sleepiness due to disrupted nighttime sleep, and the inability to maintain focus or make
reliably good judgment. Id. at 24-25.
In her affidavit, signed on August 13, 2014, petitioner averred that Dr. Mignot informed
her that persons with a particular genetic susceptibility can experience an autoimmune reaction
after receiving an H1N1 vaccination (which is included in the trivalent influenza vaccination she
received), whereby neurons which produce hypocretin are destroyed, resulting in narcolepsy and
cataplexy. Pet. Ex. 1 at 5. Dr. Mignot’s medical records note that petitioner tested positive for the
genetic HLA marker DQB1*0602, which predisposes her to narcolepsy. Pet. Ex. 8 at 14. Also in
her affidavit, petitioner stated that Dr. Mignot was able to persuade her health insurance company
to pay for Xyrem, but for only six months. Pet. Ex. 1 at 6. She further stated that Xyrem has
“eliminated the cataplexy attacks, improved her nighttime sleep, and has reduced her sleep attacks
to one a day. Id. She noted that before a sleep attack, she has approximately a 60 to 120 second
warning before she falls into REM sleep for about twenty minutes. Id. She further noted that she
continues to have episodes of micro-sleep, where she does not remember any conversation and her
communication is slow and sometimes incoherent. Id.
Petitioner avers that her condition has profoundly affected her life. Pet. Ex. 1 at 6. She is
unable to help her family pay bills or drive her four children to their activities. Id. She relies on
5
her family to transport her for her activities. Id. She lives on a farm with her husband and is unable
to contribute to their farming duties. Id.
II. ANALYSIS
A. Legal Standard
The Vaccine Act established the Program to compensate vaccine-related injuries and
deaths. § 300aa-10(a). “Congress designed the Vaccine Program to supplement the state law civil
tort system as a simple, fair and expeditious means for compensating vaccine-related injured
persons. The Program was established to award ‘vaccine-injured persons quickly, easily, and with
certainty and generosity.’” Rooks v. Sec’y of HHS, 35 Fed. Cl. 1, 7 (1996) (quoting H.R. Rep. No.
908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
In order to prevail under the Program, a petitioner must prove either a “Table” injury or
that a vaccine listed in the Table was the cause in fact of an injury (an “off-Table” injury). Here,
petitioner is not alleging a Table injury, but rather that her influenza vaccination on November 9,
2011 caused-in-fact her narcolepsy and cataplexy, off-Table injuries.
An “off-Table” injury is established when the petitioner demonstrates, by a preponderance
of the evidence: (1) that she received a vaccine set forth on the Vaccine Injury Table; (2) that she
received the vaccine in the United States; (3) that she sustained or had significantly aggravated an
illness, disease, disability, or condition caused by the vaccine; and (4) that the condition has
persisted for more than six months. § 13(a)(1)(A).
The record is clear that petitioner received a vaccine listed on the Vaccine Injury Table and
that she was vaccinated in the United States. See Pet. Ex. 4. The medical records also document
that petitioner experienced narcolepsy and cataplexy for more than six months.
To satisfy her burden of proving causation in fact, petitioner must establish each of the
three Althen factors by preponderant evidence: (1) a medical theory causally connecting the
vaccination and her injury; (2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and (3) a proximate temporal relationship between vaccination and
injury. Althen, 418 F.3d at 1278; see de Bazan v. Sec’y of HHS, 539 F.3d 1347, 1351-52 (Fed. Cir.
2008); Caves v. Sec’y of HHS, 100 Fed. Cl. 119, 132 (2011), aff. per curiam, 463 Fed. Appx. 932(Fed. Cir. 2012) (specifying that each Althen factor must be established by preponderant evidence).
The preponderance of the evidence standard, in turn, has been interpreted to mean that a fact is
more likely than not. See Moberly v. Sec’y of HHS, 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010).
Proof of medical certainty is not required. Bunting v. Sec’y of HHS, 931 F.2d 867, 873 (Fed. Cir.
1991).
In determining whether petitioner is entitled to compensation, a special master must
consider the entire record and is not bound by any particular piece of evidence. § 13(b)(1) (stating
a special master is not bound by any “diagnosis, conclusion, judgment, test result, report, or
summary” contained in the record). Thus, a special master must weigh and evaluate opposing
6
expert opinions, medical and scientific evidence, and the evidentiary record in deciding whether
petitioners have met their burden of proof.
B. Petitioner’s Expert Opinion and Althen Analysis
Petitioner filed an expert opinion from Dr. Marcel Kinsbourne. Dr. Kinsbourne is a
research professor at the Center for Cognitive Studies at Tufts University. Pet. Ex. 31 at 2. He is
also a professor of psychology at New School University, in New York. Id. Previously, he was the
director of the Behavioral Neurology Unit at Sargent College of Allied Health Professions at
Boston University. Id. Dr. Kinsbourne received medical degrees from Oxford University in
England, and Duke University in North Carolina. Id. at 1.
Dr. Kinsbourne opined that petitioner’s sleep disorder began after receipt of a trivalent flu
vaccination containing the H1N1 strain. Pet. Ex. 29 at 2-3. He opined that petitioner meets the
behavioral and objective criteria for narcolepsy. Respondent does not dispute that petitioner’s
correct diagnosis is narcolepsy with cataplexy. Res. Report at 4.
1. Althen Prong One
Under the first prong of Althen, petitioner is required to set forth a reliable medical theory
that explains how a particular vaccination can cause the injury in question. Althen, 418 F 3d at
1279. Scientific certainty is not required to establish causation under the Vaccine Act. Id. at 1280
(holding that the purpose of the Vaccine Act’s preponderance of the evidence standard “is to allow
the finding of causation in a field bereft of complete and direct proof of how vaccines affect the
human body”). However, a causation theory or mechanism must be proposed and supported by a
sound and reliable medical or scientific explanation. Knudsen v. Sec’y, HHS, 35 F.3d 543, 548
(Fed Cir. 1994).
Petitioner’s theory, provided by Dr. Kinsbourne, is consistent with Dr. Mignot’s
explanation to petitioner regarding her condition. Dr. Kinsbourne explained that hypocretin, a
neurotransmitter, contributes to a person’s waking state by an excitatory effect on several
brainstem loci that control the level of arousal. Pet. Ex. 29 at 5. Conversely, “inhibitory
neurotransmitters lower the brain’s arousal level and counteract hypocretin and other excitatory
neurotransmitters.” Id. at 5-6. This infrastructure of excitatory and inhibitory neurotransmitters
imposing opposite effects in the brainstem is known as the “sleep switch hypothesis.” Id. at 6.
More fully explained, “[w]ake promoting and sleep-promoting loci in separate regions of the
hypothalamus inhibit each other, constituting an ‘opponent system.’ Inactivation of either system
leaves the other in relative control, resulting in insomnia or in narcolepsy.” Id.
According to Dr. Kinsbourne, people with narcolepsy have been shown to be deficient in
hypocretin levels in the cerebrospinal fluid, and to also have greatly diminished numbers of
hypocretin-producing neurons in the dorsolateral hypothalamus. Pet. Ex. 29 at 6 (citing Nishino et
al., Hypocretin (orexin) Deficiency in Human Narcolepsy, 355 The Lancet 39 (2000) [Pet. Ex.
45]). Hypocretin deficiency in persons with narcolepsy is believed to be a consequence of a
destructive autoimmune attack on hypocretin-producing neurons. Pet. Ex. 29 at 6 (citing Mahlios
et al., The Autoimmune Basis of Narcolepsy, 23 Current Opinion in Neurobiology 767 (2013)
7
[Pet. Ex. 39]). Dr. Kinsbourne commented that depletion of hypocretin-producing neurons is
“‘seemingly selective,’” as the other cells intermingled with hypocretin-producing cells are left
unaffected, whereas the cells producing hypocretin are destroyed—leading to the “hypothesis that
narcolepsy is an autoimmune-driven process within the hypothalamus, presumably mediated by
CD4+ T cells.” Pet. Ex. 29 at 6; see also Pet. Ex. 39 at 767.
According to Dr. Kinsbourne and the medical literature, current thinking is that the H1N1
vaccine activates CD4+ T cells, which have a peptide mimic with self-epitopes in hypocretin
releasing neurons. Pet. Ex. 29 at 8-9; see also Pet. Ex. 42 at 3157 (noting that “narcolepsy is
characterized by the presence of autoreactive CD4+ T cells to hypocretin fragments when
presented by DQ0602,” a narcolepsy gene). Autoimmunity involving the CD4+ T cells triggers
the destruction of neurons producing hypocretin, which then leads to the development narcolepsy.
Id. According to Dr. Kinsbourne and the medical literature, in autoimmune subjects with verified
low hypocretin activity, almost all have a genetic susceptibility. See Pet. Ex. 6 at 6; Pet. Ex. 42. A
genetic susceptibility for narcolepsy was found in the petitioner here. See Pet. Ex. 8. Dr.
Kinsbourne noteed that current research is exploring a molecular mimic between epitopes of
hypocretin and proteins from an H1N1 infection or vaccination. Pet. Ex. 29 at 7; see Pet. Exs. 33,
34, 49.
Epidemiological studies in China, Finland, Sweden, France, Norway, Ireland, and Canada,
found a “significant increase in the prevalence of narcolepsy” in those populations after receipt of
the pandemic H1N1 influenza vaccine and also after H1N1 infections. Pet. Ex. 29 at 4. Dr.
Kinsbourne noted that, although those studies involved a formulation of the H1N1 vaccine
(Pandemrix) which contains an adjuvant, and the vaccine in question here did not contain an
adjuvant, these studies are nevertheless significant as “it is unlikely” that the adjuvant in
Pandemrix “is solely responsible for the causal autoimmune reaction.” Pet. Ex. 29 at 7. Petitioner
submitted multiple epidemiological studies on the increased incidence of narcolepsy following
receipt of the pandemic H1N1 influenza vaccine and also after epidemic H1N1 infections. See Pet.
Exs. 31, 41, 43, 44, 46, 47.
Based on a review of the evidence, petitioner has met her burden of setting forth a reliable
medical theory by preponderant evidence. Reliable medical literature and petitioner’s expert
opinion demonstrates that the H1N1 component of the trivalent flu vaccine can cause
autoimmunity in a susceptible individual, whereby an attack on neurons which produce hypocretin
causes disruption in the sleep/arousal centers of the brain, leading to narcolepsy.
2. Althen Prong Two
Proof of Althen prong two requires a logical explanation as to how the vaccine did cause
the injury in the petitioner. “A logical sequence of cause and effect’ means what it sounds like—
the claimant’s theory of cause and effect must be logical.” Capizzano v. Sec’y of HHS, 440 F.3d
1317, 1326 (Fed. Cir. 2006). The proof need not rise to the level of scientific certainty but rather
to the Vaccine Act’s preponderance standard under the system created by Congress, in which close
calls regarding causation are resolved in favor of injured claimants.’” Andreu, 569 F.3d at 1378.
7
Emmanuel J.M. Mignot, History of Narcolepsy at Stanford University, 58 Immunological
Research 315-39 (May 14, 2014).
8
In this case, petitioner’s treating physician, Dr. Mignot, at all times maintained that
petitioner’s narcolepsy and cataplexy were attributable to her flu vaccination, which contained
immunization against the H1N1 influenza virus. See Pet. Ex. 8 at 20; Pet. Ex. 1 at 5. Additionally,
Dr. Mignot found petitioner had tested positive for the genetic HLA marker DQB1*0602, which
indicated a genetic susceptibility to narcolepsy. Pet. Ex. 8 at 14. Dr. Mignot’s medical records and
medical literature on narcolepsy are particularly persuasive and compelling in this case.
Additionally, Dr. Kinsbourne opined that:
[a] role in the causation of narcolepsy for H1N1 vaccine is widely considered to be
biologically reasonable. Ms. Garrison was diagnosed [with narcolepsy] by the
premier expert physician in the field of narcolepsy as having experienced a vaccine
injury, by a neurobiological mechanism that has been largely elucidated. She has
the HLA risk factor for narcolepsy. She had the onset of the illness within a
medically reasonable temporal interval of a vaccination that included H1N1
vaccine . . . . Thus the trivalent influenza vaccine did cause or significantly
contribute[d] to the cause of her narcolepsy.
Pet. Ex. 29 at 9-10. The undersigned agrees with Dr. Kinsbourne and finds his opinion persuasive
for all the reasons he articulated. Accordingly, petitioner has met her burden of establishing a
logical explanation of how her vaccination caused her injury under Althen prong two.
3. Althen Prong Three
Prong three of Althen requires a showing that the timing of the onset of petitioner’s
condition was reasonable. Petitioner must show a proximate temporal relationship between
vaccination and injury. Althen, 418 F.3d at 1278.
The timing in this case is reasonable in light of the evidence. Dr. Kinsbourne noted that
“[t]he documented time intervals between H1N1 vaccination and the onset of narcolepsy have
ranged up to six months,” citing Dr. Mignot’s article which found a peak in narcolepsy cases in
China about four to six months after the peak of H1N1 infections. Pet. Ex. 29 at 9; Pet. Ex. 42 at
327. Additionally, Dr. Kinsbourne noted that “Dauvilliers [and others, including Dr. Mignot]
documented the range of vaccination to onset intervals in their sample[,] and found it to vary
between two days and twenty weeks.” Pet. Ex. 29 at 9. Dr. Kinsbourne went on to note that in
petitioner’s case, the interval was approximately two weeks.” Id.; see also Pet. Ex. 1 (averring that
petitioner began experiencing excessive daytime sleepiness in mid-November 2011, and that in
early December 2011, she experienced her first episode of suddenly falling asleep and sudden
collapses triggered by any strong emotion).
Although the vaccination date alleged in the petition and petitioner’s affidavit are
inconsistent with the date provided in medical records, in either event, the timing of the onset of
petitioner’s condition is supported by the medical literature. The onset of petitioner’s condition
appears to be in the range of one to two weeks, whether the date of onset is calculated based on
the alleged October 28, 2011 vaccination date (on which Dr. Kinsbourne based his opinion), or
9
calculated based on the vaccination date of November 9, 2011 (noted in the medical records). Both
time frames are consistent with the medical literature provided, which notes an onset of two days
to up to five months.
Accordingly, petitioner has met her burden under Althen prong three.
III. CONCLUSION
Petitioner has provided reliable and persuasive evidence under all three prongs of Althen.
Although respondent does not recommend compensation in this matter, she stated an intent not to
defend this case and presented no evidence refuting petitioner’s case. Based on a review of the
evidence, the undersigned finds that petitioner is entitled to compensation from this Program.
A damages order will be issued separately.
IT IS SO ORDERED.
s/ Thomas L. Gowen
Thomas L. Gowen
Special Master
10