Martin v. Secretary of Health and Human Services

CORRECTED

In the Anited States Court of Federal Clauns

OFFICE OF SPECIAL MASTERS

No. 17-946V

Filed: August 20, 2021

Corrected: August 23, 2021

KR KKK KKK KK KK KK KK KK KK KK KKK OK

*

JESSE MARTIN, ‘

. * TO BE PUBLISHED

Petitioner, :

*

Vs * Human Papillomavirus (“HPV”) Vaccine;

* Narcolepsy and Cataplexy; Dismissal

SECRETARY OF HEALTH AND * Decision

HUMAN SERVICES, :

*

Respondent. *

*

KKKKKKKK KKK KKK KKK KKK KK KKK *K

Danielle Strait, Maglio Christopher & Toale, Seattle, WA, for Petitioner

Catherine Stolar, U.S. Department of Justice, Washington, DC, for Respondent

DECISION ON ENTITLEMENT!

Oler, Special Master:

On July 13, 2017, Petitioner Jesse Martin? filed a petition for compensation under the

National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seg.* (the “Vaccine

' This Decision will be posted on the United States Court of Federal Claims’ website, in accordance with

the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to

anyone with access to the internet. As provided in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties

may object to the Decision’s inclusion of certain kinds of confidential information. To do so, each party

may, within 14 days, request redaction “of any information furnished by that party: (1) that is a trade secret

or commercial or financial in substance and is privileged or confidential: or (2) that includes medical files

or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.”

Vaccine Rule 18(b). Otherwise, this Decision will be available to the public in its present form. Jd.

> At the time of filing, Petitioner was under 18 years of age and the Petition was filed by his mother, Ms.

Leslie Questel, on his behalf. Petitioner Jesse Martin was named the sole Petitioner on October 1, 2019.

ECF No. 54.

3 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease

of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa

(2012).

1

Act” or “Program’’) alleging that he suffered from narcolepsy and cataplexy as a result of the HPV

vaccination he received on August 13, 2014, the HPV vaccination he received on August 18, 2016,

or some combination thereof. Pet. at 1, ECF No. 1.

Upon review of the evidence in this case, I find that Petitioner has failed to preponderantly

demonstrate that the vaccines he received caused his condition. The petition is accordingly

dismissed.

L Procedural History

Petitioner filed his petition on July 13, 2017. Pet. at 1. He filed medical records in support

of his claim on October 31, 2017 (Exs. 1, 2) and March 21, 2018 (Ex. 3). Respondent then filed

his Rule 4 Report on June 21, 2018 recommending that entitlement be denied. Resp’t’s Rep. at 1;

ECF No. 23.

Petitioner filed an expert report along with supporting medical literature on September 21,

2018. Exs. 15-34. Respondent filed a responsive expert report and supporting medical literature

on February 25, 2019. Exs. A-JJ.

Petitioner filed additional medical records throughout 2019 and 2020. Exs. 42-49. He filed

an affidavit on August 26, 2020. Ex. 50. Respondent then filed another expert report and

supporting medical literature. Exs. KK-NN.

I held a status conference on February 3, 2021 where I asked the parties whether a Rule 5

conference addressing the issue of onset of Petitioner’s symptoms would help to move the case

forward. They both indicated that it would. See Scheduling Order of February 5, 2021. ECF No.

72. [held a Rule 5 conference on February 18, 2021 where I told the parties that I tentatively found

the onset of Petitioner’s narcolepsy was in July of 2016. ECF No. 73. Based on my tentative

findings, I ordered Petitioner to file a status report by March 19, 2021 indicating how he would

like to proceed. /d.

On August 11, 2021, Petitioner filed a motion for a decision. ECF No. 79. In this motion,

Petitioner indicated that he had filed all the evidence he intends to file in this matter. /d. He further

stated that “In light of the Court’s factual analysis presented in the February 18, 2021 Order,

Petitioner’s expert is no longer able to support causation given the Court’s view on the facts of this

particular case.” /d. Petitioner indicated that he waived his right to a hearing and moved for a

decision based on the existing record. /d. Finally, Petitioner indicated that he “understands that

this motion will likely result in an unfavorable decision by the Special Master, resulting in a

judgment against Petitioner. Petitioner has been advised that such an unfavorable judgment will

end Petitioner’s claim under the Vaccine Act.” Jd.

The parties filed a joint status report on August 17, 2021 indicating that “the record in this

matter is complete and a decision by the Court on Petitioner’s August 11, 2021 Motion for

Decision is appropriate.” ECF No. 80. This matter is now ripe for an adjudication.

IL. Relevant Medical Records

On August 13, 2014, Petitioner received a Human Papillomavirus (“HPV”), Hepatitis A,

Varicella, and meningococcal conjugate vaccination. Ex. | at 1.

Petitioner visited the emergency room three times between March and May 2016. He did

not mention fatigue at any of these visits. On March 1, 2016, Petitioner visited the ER for “cough

and fever since Saturday.” Ex. 2 at 29. He went to the ER on May 5, 2016 for a sore throat and

fever x 3 days. Ex. 2 at 18. On May 18, 2016 he went to the ER for “left rib pain x2 days.” /d. at

6. During the May 18 visit, Petitioner specifically denied fatigue. /d. at 16.

On August 18, 2016, Petitioner visited Kaiser Permanente. The noted reason for his visit

included fatigue and sleep problems. Ex. 1 at 5-7. These records indicate that Petitioner started

having difficulties staying asleep “6 weeks ago during school vacation.” /d. at 5. The medical

records note that Petitioner was able to fall asleep quickly but woke up multiple times at night. /d.

Petitioner was falling asleep during class and at football practice, while at the computer and even

when friends were over. /d. He reportedly had issues with insomnia prior to this when he would

stay up all night and sleep during the day. /d. Petitioner was further noted to have irregular eating

habits where he would not eat breakfast or lunch, eat dinner after football practice, and then wake

in the middle of the night to eat. /d. Dr. Lu referred Petitioner to the sleep clinic for further

evaluation. Ex. 1 at 6. Petitioner received his second dose of the HPV vaccine at this appointment.

Id. at 1.

On August 29, 2016, Petitioner presented to KP Fontana Sleep Center for a sleep

consultation. Ex. 1 at 17-24. During the visit, Petitioner indicated that he had been experiencing

excessive daytime sleepiness for the past four to five months, that was “getting really bad x 6

weeks.” /d. at 18. The record further notes:

Prior to this new sleepiness all the time, he would stay up late at night on phone,

Eat 3am, go to sleep, get up on time for school, stayed awake in school and football

practice fine. Slept in on weekends. This summer took a long road trip through

many national parks - Jesse slept day and night through almost all the trip.

Id. Petitioner also indicated that he had experienced sleep paralysis, cataplexy, weakness after

being emotional, staring into space blankly, dropping or suddenly falling asleep while taking,

eating, or standing, and that he sleepwalks and talks. Jd. Dr. Hwang’s clinical diagnosis was

narcolepsy with cataplexy, but he noted that Petitioner needed additional testing to confirm this

diagnosis. /d. at 20. Dr. Hwang scheduled Petitioner for a polysomnography sleep study and mean

sleep latency test. /d.

On September 11 and 12, 2016, Petitioner underwent a polysomnogram sleep study and a

mean sleep latency test. Ex. 1 at 25-27; 29. The results of the polysomnography sleep study led to

a diagnosis of no significant obstructive sleep apnea, upper airway resistance syndrome, and

periodic limb movement syndrome. /d. at 27. The mean sleep latency test led to a diagnosis of

narcolepsy. /d. at 29.

On October 24, 2016, Petitioner was seen by Chelsea Walsh, M.A. for a therapy session at

Walsh Therapy Center. Ex. 46 at 26. Petitioner’s file states that he was seeking help for

“narcolepsy and cataplexy since HPV shot (first dose 2014 and second dose was August 2016).”

Id. at 28. The records also note “No symtpoms [sic] until HPV shot in 2014” and that “[Petitioner]

is a [sic] law suite [sic] against the manufacturer of HPV vaccine.” /d. at 29, 33.

On November 29, 2016, Petitioner’s mother called Dr. Kendra Becker to discuss his

narcolepsy/cataplexy. Ex. 3 at 212. Dr. Becker noted that “Patient first excessive daytime

sleepiness appeared after first vaccine, and narcolepsy symptoms started one week after second

dose.” /d. Dr. Becker further wrote “Patient is now represented by US federal attorneys — class

action suit against Merck Gardasil HPV vaccine. Parent noticed that cataplexy begun about a week

and half [sic] after second shot was administered.” /d.

Il. Affidavits

A. Leslie Questel’s Affidavit

Petitioner’s mother, Leslie Questel signed her affidavit on September 18, 2018. Ex. 5 at 6.

Ms. Questel stated that “within a couple months” of his August 13, 2014 vaccinations, she started

to notice small changes in Petitioner’s sleeping schedule. /d. at 2. Specifically, he stayed up very

late and had trouble falling asleep. Jd. Ms. Questel’s husband would come home late at night and

see Petitioner playing on his game system or phone. /d. Petitioner told his step-father that he was

not tired or that he couldn’t get to sleep. /d.

As time went on, Ms. Questel noticed that Petitioner was sleeping during the day and was

having difficulty sleeping at night. Ex. 5 at 2. She observed Petitioner to be asleep when his friends

came over to the house. /d. Petitioner told her that he “couldn’t help but fall asleep.” Jd. Ms.

Questel thought he was going through a teenage phase. /d.

She further described that during the summer of 2016, their family went on a vacation to

Montana, with stops in Utah, Wyoming, and South Dakota. Ex. 5 at 2. Petitioner continued with

his sleeping issues throughout the trip. /d. at 3. During this vacation, Ms. Questel and the rest of

the family agreed that Petitioner’s condition seemed serious. /d.

Petitioner’s school started in August and he had issues staying awake during class. Ex. 5

at 3. Ms. Questel decided to bring him to the doctor. /d. During the medical appointment on August

18, 2016, Dr. Lu indicated that she believed Petitioner’s problems were a result of not being on a

proper sleep schedule. /d. Petitioner received the second dose of the HPV vaccine at this visit. /d.

Ms. Questel stated that after this appointment, Petitioner started getting worse in that he

began having issues with his knees buckling during football. Ex. 5 at 3. She began noticing

cataplexy in Petitioner’s face when he was falling asleep. /d. Additionally, Petitioner told them

that sometimes he would feel like he was awake but was unable to move. /d. at 4. After his sleep

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studies, Petitioner was diagnosed with narcolepsy. /d. Ms. Questel discussed the difficulties

Petitioner’s condition has caused for him and for their family. /d. at 5-6.

B. Petitioner’s Affidavit

Petitioner signed his affidavit on August 18, 2020. Ex. 50 at 6. He stated that he does not

remember having any issues with “getting to sleep, staying asleep, or being abnormally sleepy

during the day” from the fall through mid-November of 2014. /d. at 2. Petitioner described that he

began to have the urge to sleep during the day shortly after football season ended. /d. This was

during his seventh grade school year. /d. He also developed difficulty sleeping at night. /d.

Petitioner described that in 2015, his nighttime sleep was irregular. Ex. 50 at 3. In early

2016, he began getting up in the middle of the night to have a bowl of cereal, chips and a sandwich.

Id. During this time, when he fell asleep in class, Petitioner described feeling “a sudden urge to

sleep, whether I was tired ... or not.” /d. His teachers blamed him sleeping in class on his attitude.

Id.

During the summer of 2016, Petitioner went on a road-trip vacation with his family. Ex.

50 at 3. Petitioner stated that he does not remember much of the trip because he was sleeping all

the time. /d. Petitioner described experiencing one episode of cataplexy during this 2016 vacation.

Id. He stated, “I remember waking up at my grandparents’ home in Montana, not being able to

move, and being really terrified of something. I was staring down their hallway and I could only

move my eyes.” /d.

Petitioner received his second HPV vaccine on August 18, 2016. Ex. 50 at 4.

Approximately three days later, Petitioner stated that he went out to breakfast with his family and

kept dropping his fork. /d. He stated this was the first time he felt weakness and lost control over

his body during the daytime. Jd.

Petitioner stated that it seemed like “everything went off a cliff’ after his second HPV

vaccine. Ex. 50 at 4. Within a couple of weeks, his cataplexy worsened. /d. He continued to try to

play freshman football but was unable to continue because he would fall asleep when he was not

active. /d. at 5.

IV. Respondent’s Expert Opinion

Respondent filed two expert reports from Dr. Maryann Deak. (Ex. A (hereinafter “First

Deak Rep.”) and Ex. KK, (hereinafter “Second Deak Rep.”)). Respondent also filed an expert

report from Dr. J. Lindsay Whitton.* Ex. C.

* Dr. Whitton opined that “the vaccines administered to J.M. on 8/13/2014 and 8/18/2016 played no

demonstrable role in the initiation, or subsequent evolution, of his reported symptoms.” Whitton Rep. at

17. The majority of his report focuses on rebutting Dr. Steinman’s expert opinion. Because Dr. Steinman

has indicated he is unable to provide a supportive opinion in Petitioner’s case, given my tentative findings

in the Rule 5 conference regarding the onset of Petitioner’s narcolepsy, I have not provided a summary of

either Dr. Steinman’s or Dr. Whitton’s expert opinion.

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A. Dr. Maryann Deak

Dr. Deak is board-certified in both neurology and sleep medicine; she is currently

employed at eviCore healthcare, where she performs clinical case reviews in sleep medicine. Ex.

B (hereinafter “Deak CV”). Dr. Deak graduated from Georgetown University School of Medicine

in 2004. Deak CV at 2. She completed residencies in neurology at New York University and

University of Massachusetts, and then served as a clinical and research fellow in sleep medicine

at Brigham and Women's Hospital at Harvard Medical School. /d. Dr. Deak has written several

articles and book chapters in the area of sleep disorders. /d. at 2-3. She has significant experience

treating sleep disorders, to include narcolepsy. First Deak Rep. at 1.

Dr. Deak outlined the criteria for a diagnosis of narcolepsy type I. These criteria include

excessive daytime sleepiness, and one or both of the following two criteria 1) cataplexy° and a

positive mean sleep latency test (mean sleep latency less than or equal to 8 minutes and two or

more sleep onset-REM periods); 2) cerebrospinal fluid hypocretin-1 less than 110 pg/ml or less

than 1/3 of the mean values in normal subjects. First Deak Rep. at 3-4.

Based on her review of the medical records filed in this case, Dr. Deak opined that

Petitioner’s symptoms are not related to the HPV (or varicella) vaccines he received because the

time course of his illness is inconsistent with a vaccine related event, and further because there is

no probable causal link between HPV vaccine and narcolepsy. First Deak Rep. at 2.

Dr. Deak opined that Petitioner developed narcolepsy six weeks prior to his August 18,

2016 visit with Dr. Lu. First Deak Rep. at 2. She stated that:

In the summer of 2016, J.M. was experiencing the following symptoms: 1) sleep

maintenance insomnia, without difficulty initiating sleep 2) excessive daytime

sleepiness, independent of nighttime sleep duration 3) sleep paralysis 4) cataplexy

(Ex. 3 at 152-153). These most likely represent the first symptoms of narcolepsy

experienced by J.M.

Id. She does not believe that the sleep-related symptoms that Petitioner reported four to five months

before his worsening in the summer of 2016 represented the onset of his narcolepsy for two main

reasons. /d. at 3. First, Petitioner did not report that he was experiencing significant daytime

sleepiness. /d. Second, the delayed onset of sleep is not a symptom of narcolepsy. /d.

Dr. Deak commented that “[f]or 4-5 months prior to 8/2016, the notes recount a history of

‘staying up late at night on the phone’ (Ex. 42 at 340) and ‘stay[ing] up all night’ (Ex. 42 at 300),

resulting in ‘sleep[ing] during the daytime’ (Ex. 42 at 300), but still permitting J.M. to ‘get up on

time for school, stay[] awake in school and football practice fine’ (Ex. 42 at 340).” Second Deak

> Cataplexy is characterized by brief bilateral sudden loss of muscle tone while maintaining consciousness

and is typically precipitated by strong emotions. First Deak Rep. at 3.

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Rep. at 1. Accordingly, in Dr. Deak’s opinion, “the 4-5 month history of delayed sleep onset is

most consistent with delayed sleep phase, behaviorally induced insufficient sleep or a combination

of both, which are common in adolescence.” First Deak Rep. at 3.

Dr. Deak additionally stated that even if Petitioner’s narcolepsy did develop four to five

months before his August 2016 appointment with Dr. Lu, “this would still be > 1 year after

vaccination on 8/13/14 and not appropriate for a causal relationship with any of the vaccinations

alleged.” Jd.

With respect to vaccines and narcolepsy, Dr. Deak stated that to her knowledge “there is

no evidence that the HPV, meningococcal, or varicella zoster vaccine has been linked with

narcolepsy.” First Deak Rep. at 5.

V. Applicable Law

A. Petitioner’s Burden in Vaccine Program Cases

Under the Vaccine Act, when a petitioner suffers an alleged injury that is not listed in the

Vaccine Injury Table, a petitioner may demonstrate that she suffered an “off-Table” injury.

§ 11(e)AC)Gi).

In attempting to establish entitlement to a Vaccine Program award of compensation for a

off-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit

in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005). Al/then requires that

petitioner establish by preponderant evidence that the vaccination she received caused her 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 was the reason for the injury; and (3) a

showing of a proximate temporal relationship between vaccination and injury.” /d. at 1278.

Under the first prong of A/then, petitioners must provide a “reputable medical theory,”

demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at

1355-56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound

and reliable medical or scientific explanation.” Knudsen v. Sec ’y of Health & Hum. Servs., 35 F.3d

543, 548 (Fed. Cir. 1994). Proof that the proffered medical theory is reasonable, plausible, or

possible does not satisfy a petitioner’s burden. Boatmon y. Sec’y of Health & Hum. Servs., 941

F.3d 1351, 1359-60 (Fed. Cir. 2019).

Petitioners may satisfy the first Al/then prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical

theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing

Capizzano, 440 F.3d at 1325-26). However, special masters are “entitled to require some indicia

of reliability to support the assertion of the expert witness.” Boatmon, 941 F.3d at 1360, quoting

Moberly, 592 F.3d at 1324. Special Masters, despite their expertise, are not empowered by statute

to conclusively resolve what are complex scientific and medical questions, and thus scientific

evidence offered to establish A/then prong one is viewed “not through the lens of the laboratorian,

but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Jd. at

7

1380. Accordingly, special masters must take care not to increase the burden placed on petitioners

in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of Health & Hum.

Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017);

see also Hock v. Sec’y of Health & Hum. Servs., No. 17-168V, 2020 U.S. Claims LEXIS 2202 at

*52 (Fed. Cl. Spec. Mstr. Sept. 30, 2020).

The second A/then prong requires proof of a logical sequence of cause and effect, usually

supported by facts derived from a petitioner’s medical records. A/then, 418 F.3d at 1278; Andreu,

569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion

testimony are favored in vaccine cases, as treating physicians are likely to be in the best position

to determine whether a ‘logical sequence of cause-and-effect show|[s] that the vaccination was the

reason for the injury’”) (quoting A/then, 418 F.3d at 1280). Medical records are generally viewed

as particularly trustworthy evidence, since they are created contemporaneously with the treatment

of the patient. Cucuras v. Sec ’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se

bind the special master to adopt the conclusions of such an individual, even if they must be

considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,

conclusion, judgment, test result, report, or summary shall not be binding on the special master or

court’). As with expert testimony offered to establish a theory of causation, the opinions or

diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions

or bases. The views of treating physicians should also be weighed against other, contrary evidence

also present in the record. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011),

aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health & Hum. Servs., No. 06-522V, 2011

WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344,

356 (2011), aff'd without opinion, 475 Fed. App’x 765 (Fed. Cir. 2012).

The third A/then prong requires establishing a “proximate temporal relationship” between

the vaccination and the injury alleged. A/then, 418 F.3d at 1281. That term has been equated to

the phrase “medically-acceptable temporal relationship.” /d. A petitioner must offer “preponderant

proof that the onset of symptoms occurred within a timeframe which, given the medical

understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan

v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what

is amedically acceptable timeframe must also coincide with the theory of how the relevant vaccine

can cause an injury (A/then prong one’s requirement). /d. at 1352; Shapiro v. Sec’y of Health &

Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012),

aff'd mem., 503 F. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-

355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl.

Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

Petitioner’s medical records are presumed to be accurate and complete and are afforded

substantial weight. Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed.

Cl. 598, 608 (2010); Lowrie v. Sec ’y of Health & Hum. Servs., No. 03-1585V, 2005 WL 6117475,

at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005).

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory connecting the vaccine to the injury often

requires a petitioner to present expert testimony in support of her claim. Lampe v. Sec’y of Health

& Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually

evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell

Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs.,

617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d

1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony are:

(1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique

has been subjected to peer review and publication; (3) whether there is a known or potential rate

of error and whether there are standards for controlling the error; and (4) whether the theory or

technique enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at

1316 n.2 (citing Daubert, 509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do

when applied in other federal judicial fora. Daubert factors are employed by judges to exclude

evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these

factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health

& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (uniquely in this Circuit, the Daubert factors have

been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of

expert testimony already admitted”).

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s

case. Where both sides offer expert testimony, a special master’s decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion

“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743

(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to

require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592

F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a

particular expert’s credibility, is part of the overall reliability analysis to which special masters

must subject expert testimony in Vaccine Program cases. /d. at 1325-26 (“[a]ssessments as to the

reliability of expert testimony often turn on credibility determinations”).

D. Consideration of Medical Literature

Although this decision discusses some but not all of the medical literature in detail, I

reviewed and considered all of the medical records and literature submitted in this matter. See

Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally

presume that a special master considered the relevant record evidence even though [s]he does not

explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health & Hum. Servs.,

115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every piece of

9

evidence or testimony in her decision.’” (citation omitted)), aff'd, 601 F. App’x 982 (Fed. Cir.

2015).

VI. Analysis

Because Petitioner does not allege an injury listed on the Vaccine Injury Table, his claim

is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, Petitioner must

prove by preponderant evidence that he suffered an injury and that this injury was caused by the

vaccination at issue. See Capizzano, 440 F.3d at 1320.

A. Factual Finding Regarding Onset of Petitioner’s Narcolepsy

Petitioner filed several medical records that were particularly pertinent with respect to the

issue of onset.

On August 18, 2016, Petitioner presented to Kaiser Permanente Medical Center. These

records indicate: “6 weeks ago during school vacation, started having difficulties staying asleep.”

Ex. 1 at 5. Dr. Loan Thuy Lu’s notes also indicate that “prior to this, [Petitioner] had issues with

insomnia and would stay up all night and sleep during the day time.” /d.

On August 29, 2016, Petitioner presented to Dr. Dennis Hwang for a follow up regarding

his sleep issues. Ex. 1 at 18. Dr. Hwang noted Petitioner’s “excessive daytime sleepiness duration:

4-5 months, getting really bad x 6 weeks.” /d. Dr. Hwang further noted that “Prior to this new

sleepiness all the time, he would stay up late at night on phone, Eat 3am, go to sleep, get up on

time for school, stayed awake in school and football practice fine.” /d.

On October 24, 2016, Petitioner was seen by Chelsea Walsh, M.A. for a therapy session at

Walsh Therapy Center. Ex. 46 at 26. Petitioner’s file states that he was seeking help for

“narcolepsy and cataplexy since HPV shot (first dose 2014 and second dose was August 2016).”

Id. at 28. The records also note that “[Petitioner] is a [sic] lawsuite [sic] against the manufacturer

of HPV vaccine.” /d. at 33.

On November 29, 2016, Petitioner’s mother called Dr. Kendra Becker to discuss his

narcolepsy/cataplexy. Ex. 3 at 212. Dr. Becker noted that “Patient first excessive daytime

sleepiness appeared after first vaccine, and narcolepsy symptoms started one week after second

dose.” /d. Dr. Becker further wrote “Patient is now represented by US federal attorneys — class

action suit against Merck Gardasil HPV vaccine. Parent noticed that cataplexy begun about a week

and half [sic] after second shot was administered.” /d.

In her first expert report, Dr. Deak noted that: “I do not believe that delayed sleep initiation

reported several months prior to the onset of narcolepsy represent a symptom of narcolepsy,

because 1) significant daytime impairment was not reported and 2) delayed sleep onset is not a

symptom of narcolepsy.” First Deak Rep. at 4.

In examining these medical records, I find the records from August 18, 2016 and August

29, 2016 to be more persuasive than the October 24, 2016 and November 29, 2016 records. I find

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this to be true for two primary reasons. First, the August records were created contemporaneously

with Petitioner’s recognition of his sleep issues. Petitioner and his mother provided information to

medical providers in order to facilitate diagnosis and treatment. In general, contemporaneous

medical records are presumed to be accurate and complete. Cucuras v. Sec’y of Health & Hum.

Servs., 933 F.2d 1525, 1528 (Fed. Cir. 1993). Second, the August records are persuasive because

there is no indication they were created in anticipation of litigation. See, e.g., Sheets v. Sec’y of

Health & Hum. Servs., No. 16-1173V, 2019 U.S. LEXIS 587 at *56 (Fed. Cl. Spec. Mstr. Apr. 30,

2019) (later-in-time statements whether made to treaters or prepared for purposes of litigation do

not suffice to contradict contemporaneous records). The same cannot be said of the October and

November records, which each make specific mention of litigation. The August 18, 2016 and

August 29, 2016 records both indicate that Petitioner’s symptoms began six weeks prior to these

visits, or approximately in the July 2016 timeframe. While these notes indicate some degree of

sleepiness beginning in approximately April-May of 2016, I find Dr. Deak’s discussion on this

point to be persuasive.

In making these factual determinations, I have also concluded that the medical records and

medical histories provided close-in-time to Petitioner’s injury are more persuasive than the

affidavits drafted between approximately two and four years after the fact.° Special Masters in the

Vaccine Program “have traditionally declined to credit later testimony over contemporaneous

records.” Sturdivant v. Sec’y of Health & Hum. Servs., No. 07-788V, 2016 WL 552529, at *15

(Fed. Cl. Spec. Mstr. January 21, 2016). See, e.g., Stevens v. Sec’y of Health & Hum. Servs., No.

90-221V, 1990 WL 608693, at *3 (Cl. Ct. Spec. Mstr. December 21, 1990); see also Vergara vy.

Sec’y of Health & Hum. Servs., No. 08-882V, 2014 WL 2795491, at *4 (Fed. Cl. Spec. Mstr. July

17, 2014) (Special Masters frequently accord more weight to contemporaneously-recorded

medical symptoms than those recorded in later medical histories, affidavits, or trial testimony.”);

See also, Cucuras, 993 F.2d at 1528 (noting that “the Supreme Court counsels that oral testimony

in conflict with contemporaneous documentary evidence deserves little weight’).

I will add that regardless of whether onset of narcolepsy occurred in April-May of 2016 or

July of 2016, both of these dates occurred more than one year after Petitioner’s first HPV vaccine,

and before his second. For the reasons discussed above, I find the contemporaneous records created

on August 18, 2016 and August 29, 2016 to be more persuasive than the October and November

records and the affidavits filed in this case. I further find that Dr. Deak effectively explained

Petitioner’s daytime sleepiness four to five months prior to the August 29, 2016 appointment as

unrelated to his subsequent narcolepsy diagnosis. I therefore find that the onset of Petitioner’s

symptoms associated with narcolepsy more likely than not began in July 2016.

B. Petitioner Has Not Carried His Burden of Proof

In a motion for a decision filed on August 11, 2021, Petitioner stated that based on my

factual finding regarding the onset of his narcolepsy, Dr. Steinman “is no longer able to support

° The affidavits drafted by Petitioner and his mother which claim onset of excessive daytime sleepiness

shortly after the 2014 HPV vaccine are also belied by the medical records from March and May 2016 where

Petitioner visited the ER three times and did not mention fatigue. See Ex. 2 at 16, 18, 29.

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causation...” ECF No. 79. Without an expert opinion, Petitioner cannot sustain his burden of proof.

Althen, 418 F.3d at 1278.

To receive compensation under the Vaccine Program, a petitioner must prove either (1)

that he suffered a “Table Injury” — 1.e., an injury falling within the Vaccine Injury Table —

corresponding to his vaccination, or (2) that he suffered an injury that was actually caused by a

vaccine. See §§ 13(a)(1)(A) and 11(c)(1). Moreover, under the Vaccine Act, a petitioner may not

receive a Vaccine Program award based solely on his claims alone. Rather, the petition must be

supported by either medical records or by the opinion of a competent medical expert. § 13(a)(1).

In this case, however, there is insufficient evidence in the record for Petitioner to meet his burden

of proof. Petitioner’s claim therefore cannot succeed and must be dismissed. § 11(c)(1)(A).

VII. Conclusion

Upon careful evaluation of all the evidence submitted in this matter, I conclude that

Petitioner has not shown by preponderant evidence that he is entitled to compensation under the

Vaccine Act. His petition is therefore DISMISSED. The clerk shall enter judgment

accordingly.’

IT IS SO ORDERED.

s/ Katherine E. Oler

Katherine E. Oler

Special Master

7 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly

or separately) a notice renouncing their night to seek review.

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