Zumwalt v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 16-994V

(Not to be published)

*************************

NICHOLAS ZUMWALT, *

on behalf of his minor child, L.Z., *

* Special Master Corcoran

Petitioner, *

* Filed: March 21, 2019

v. *

* Tetanus-Diphtheria-Acellular

SECRETARY OF HEALTH AND * Pertussis Vaccine; Seizure Disorder;

HUMAN SERVICES, * Althen Prong One; Treating Doctor

* Opinion; Althen Prong Two.

Respondent. *

*

*************************

Andrew D. Downing, Van Cott & Talamante, Phoenix, AZ, for Petitioner.

Ryan D. Pyles, U.S. Dep’t of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION1

Nicholas Zumwalt, as legal representative of his minor child, L.Z., filed a petition on

August 12, 2016, seeking compensation under the National Vaccine Injury Compensation Program

(“Vaccine Program”).2 Pet. at 1 (ECF No. 1). Mr. Zumwalt alleged that L.Z.’s seizure disorder

was caused by some or all of the following vaccines administered on March 24, 2014: Prevnar 13

(pneumococcal), Pediarix (polio, hepatitis B, and diphtheria-tetanus-acellular pertussis (“DTaP”)),

1

Although this Decision has been formally designated “not to be published,” it will nevertheless be posted on the

Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This

means that the Decision will be available to anyone with access to the internet. As provided by 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.

Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to 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, the whole decision will be available to the public

in its current form. Id.

2

The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-

10–37 (2012) (hereinafter “Vaccine Act” or “the Act”). Individual section references hereafter shall refer to § 300aa

of the Act.

ActHib 4 (Haemophilus influenzae type B) (“Hib”), and RotaTeq (rotavirus). Id.

An entitlement hearing was held in this matter on October 9, 2018. After consideration of

the record and testimony provided at hearing, I find that Petitioner is not entitled to a compensation

award. As discussed in more detail below, Petitioner has not set forth a reliable theory explaining

how any of the vaccines L.Z. received on March 24, 2014, could have caused his injuries.

I. Factual Background

Pre-Vaccination History

L.Z. was born premature at almost thirty-six weeks on September 24, 2013. Ex. 21 at 4,

filed Nov 3, 2016 (ECF Nos. 11-3–11-4). He spent his first six days in the neonatal intensive care

unit due to a high heart rate at birth, which was ultimately diagnosed as supraventricular

tachycardia.3 Id. His heart rate decreased after cardioversion,4 and he was prescribed medication

to help him maintain a normal heart rate thereafter. Id. at 5.

At his one-month well-child visit with Geeta Silas, M.D., L.Z. seemed to be in good health.

See Ex. 3 at 72–75, filed Aug. 23, 2016 (ECF No. 5-3). The only concern noted was a rash near

his urethral opening, and Dr. Silas recommended he continue to receive heart rate medication

prophylactically. Id. at 74–75. L.Z.’s two-month check-up was similarly unremarkable. Id. at 67–

71. He received his two-month vaccinations without incident, and Dr. Silas deemed his

development to be appropriate for his age in all areas, although he continued to receive heart rate

medication. Id. at 67, 70–71.

While L.Z.’s overall physical health at his four-month well-child check-up appeared good,

Dr. Silas began to express concerns about his development. See Ex. 3 at 61–66. Specifically, she

noted delays in his social interaction and eye contact, which she found to be “inconsistent for age.”

Id. at 61. He passed eight of the twelve developmental milestones assessed at this visit but failed

to visually track objects beyond the midline, bring a toy to his mouth while in a supine position,

orient to a voice, or laugh out loud. Id. at 62. She also noted that L.Z. would frequently spit up,

indicating reflux. Id. at 61. Dr. Silas prescribed Zantac (ranitidine) for L.Z.’s reflux and continued

digoxin for his heart. Id. at 65. He received his four-month vaccinations, again without incident.

Id. at 65.

On March 24, 2014, L.Z. presented for his six-month check-up with Dr. Silas. Ex. 3 at 55–

59. At this visit, Dr. Silas expressed additional concerns about his development. See id. In

3

Supraventricular tachycardia is an elevated heart rate, specifically occurring where contraction begins above the

heart’s ventricles. Dorland’s Illustrated Medical Dictionary 1867–68 (32nd ed. 2012) (hereinafter “Dorland’s”).

4

Cardioversion is an electric shock given to restore the normal heart rate. Dorland’s at 295.

2

particular, she identified increased tone in his lower extremities, head lag, problems with eye

contact, and that he held his hands in tight fists.5 Id. at 57. She noted in the relevant medical record

“slight delay!!” and “inappropriate interaction” with regard to his neurological and psychiatric

systems, and he failed two of the twelve six-month developmental milestones: reaching for and

raking at objects, and transferring objects hand to hand (by five months of age). Id. at 56–57. Based

upon these developmental concerns, Dr. Silas referred L.Z.’s parents to Laura Taylor, D.O., a

pediatric development specialist, and to the Oklahoma “SoonerStart” Early Intervention center.6

Id. at 58–59.

Vaccinations and Alleged Reaction

L.Z. received his six-month vaccinations at the March 24, 2014 visit with Dr. Silas:

ActHib 4 and Prevnar 13 in his left shoulder, Pediarix in his right shoulder, and RotaTeq orally.

Ex. 3 at 58. He did not experience any sort of reaction immediately after receiving the vaccines.

Tr. at 7. On March 28, 2014—four days after vaccination, but prior to L.Z.’s alleged reaction—he

was evaluated to determine eligibility for the early intervention services recommended by Dr.

Silas. See generally Ex. 12. Evaluators determined that L.Z. was eligible for such services based

on “delays (significant) . . . in adaptive, fine motor, and cognitive skills.” Id. at 3. L.Z. did not pass

the vision screening exam, and he was referred for a follow-up hearing appointment. Id. at 1.

Despite the above developmental concerns documented in the record, Petitioner has stated

that he and Mrs. Zumwalt did not find L.Z.’s developmental delays to be of great concern, as they

perceived L.Z.’s development overall to be largely normal. See Ex. 1 at 1, filed Aug. 23, 2016

(ECF No. 5-1) (“Pet. Aff.”). Thus, Petitioner alleged that prior to his alleged vaccine reaction, L.Z.

ate and slept well, rolled over, smiled, laughed, and sucked his fists. Id. at 1. To the extent that the

Zumwalts did observe developmental delays, L.Z.’s parents attributed them to his prematurity. Id.

According to Petitioner’s observations, L.Z.’s health began to decline sharply late in the

evening of April 1, 2014, eight days after the relevant vaccinations. Pet. Aff. at 1; Tr. at 7–8. L.Z.

did not rouse himself from his evening nap as he usually would, and when Mr. Zumwalt went to

wake him, he appeared limp, pale, and unresponsive. Pet. Aff. at 1; Tr. at 8. Petitioner

unsuccessfully attempted to elicit a response to various stimuli, including pain, his bottle, and

being bathed. Tr. at 8–9. There is no record evidence for the period between the March 24th

vaccinations and the evening of April 1st establishing any other related symptoms, however, and

none are alleged.

5

While the medical records from this March 24, 2014 visit do not specifically discuss the significance of L.Z. making

tight fists, both of Petitioner’s experts testified at hearing that this could be indicative of a neurological condition. Tr.

at 54, 110.

6

Based on the records filed in this case, SoonerStart appears to be a multidisciplinary care center that evaluates

children for developmental delays and provides care and assistance to such children. See generally Ex. 12, filed Aug.

23, 2016 (ECF No. 6-3).

3

Concerned by L.Z.’s demeanor and failure to respond to stimuli, the Zumwalts brought

L.Z. to the pediatric emergency room (“ER”) at St. Francis Hospital in Tulsa, Oklahoma, on the

night of April 1, 2014. Pet. Aff. at 2. Petitioner reported that ER treaters observed L.Z.

experiencing seizure-like activity, and accordingly ordered a computerized tomography (“CT”)

scan of his head. Id. L.Z. was given anti-seizure medication which seemed effective. Ex. 11 at 45,

filed Aug. 23, 2016 (ECF Nos. 6-1–6-2). The CT scan was conducted and revealed no acute

intracranial abnormalities. Ex. 22 at 2464, filed Nov. 18, 2016 (ECF Nos. 13-1–13-10). L.Z. had

no fever associated with this initial seizure onset. Id. at 2522.

The next evening (April 2, 2014),7 L.Z. was admitted to St. Francis in status epilepticus,

with right lip smacking and right clonic arm movement. Ex. 22 at 2522. At the time of this

admission, treaters now noted a low-grade fever. Id. He was initially seen on the general pediatric

floor but was soon transferred to the pediatric intensive care unit. Id. A head CT scan on the day

of his admission was abnormal, showing asymmetry with possible structural defects in the left

frontoparietal region. Ex. 11 at 45–46. An overnight continuous study electroencephalogram

(“EEG”) the night of April 2nd was also abnormal, reflecting left hemispheric slowing with

periodic lateralizing epileptiform activity over the left, but without seizures. Id. A brain magnetic

resonance imaging (“MRI”) conducted on April 4th, however, showed no evidence of structural,

infectious, or hemorrhagic/ischemic injury and was “completely normal.” Id. at 47. An initial

lumbar puncture showed cerebrospinal fluid (“CSF”) pleocytosis8 of 256 white blood cells. Ex. 22

at 1339. A repeat lumbar puncture performed soon thereafter, however, showed markedly reduced

(and hence less concerning) pleocytosis, with the count now down to 14 white blood cells. Id.

L.Z. was discharged on April 17, 2014. Ex. 22 at 1923. At this time, he was prescribed

phenobarbital to control his seizures, Prevacid to control reflux, acyclovir for possible viral

infections, and additional anti-seizure medication. Id. at 1926. However, L.Z. suffered another

seizure ten days later on April 27, 2014, for which he returned to the St. Francis ER. Id. at 1321.

His parents reported that L.Z. had showed marked improvement during his time at home (and there

is no record evidence to the contrary), but then had begun to act strangely the evening of April

26th (no eye contact, not interactive). Id. at 1339. In the ER, L.Z. was treated with a variety of

aggressive medications, including benzodiazepines, phenobarbital, and Keppra, but his seizing

continued, and he was subsequently placed in a pentobarbital-induced coma on April 29th. Id. at

7

It is unclear from the record whether L.Z. was discharged from the St. Francis pediatric ER and returned to the

hospital less than one day later, or whether he was simply transferred internally to another department. Compare Pet.

Aff. at 2 (describing ER admission on evening of April 1 and stating that L.Z. was “admitted to the hospital for

additional tests” after CT scan and not discharged until April 17, 2014) with Ex. 22 at 2522 (April 2nd admit/transfer

note stating that L.Z. had a seizure twenty-four hours earlier, “was evaluated in another emergency department and

then sent home”).

8

Pleocytosis is characterized by the presence of a higher number of white blood cells in the CSF than usual. Dorland’s

at 1460. Both parties’ experts agreed that pleocytosis is evidence of an existing inflammatory process. Tr. at 101, 162.

4

1321, 1341. A May 6th MRI showed decreased brain volume since his previous MRI on April 4th.

Ex. 22 at 1677. L.Z. was transferred to Cook Children’s Hospital in Fort Worth, Texas, on May

6th, where additional intense medication still failed to put a stop to his seizures. Ex. 13 at 426,

filed Aug. 23, 2016 (ECF Nos. 6-4–6-5).

On May 14, 2014, L.Z. was transferred back to St. Francis. Pet. Aff. at 2. A twenty-four-

hour video EEG was conducted from May 25th–26th. Ex. 22 at 1163. The exam showed frequent

electrographic seizures, centralized background slowing with right hemispheric asymmetric

slowing, and frequent multifocal epileptiform discharges, but no clinical seizures. Id. at 1163–64.

L.Z.’s treating pediatric neurologist, David Siegler, M.D., (whose testimony at hearing is discussed

in detail below) deemed these results consistent with a diagnosis of infantile epileptic

encephalopathy. Id. at 1164. The records from this part of L.Z.’s medical history do not identify

the March 2014 vaccinations as potentially causal.

L.Z.’s condition has not changed significantly since his discharge from St. Francis on May

25, 2014. Records from late July 2016 show that he is still profoundly disabled, nonverbal,

dependent on a feeding tube, and has poor visual interaction. Ex. 23 at 11, filed Dec. 7, 2016 (ECF

No. 14-1). According to his father, L.Z. requires constant care, suffers frequent seizures, is

quadriplegic, and has experienced severe brain volume loss. Pet. Aff. at 3.

Elimination of Possible Etiologies

In June of 2014, Dr. Siegler informed the Zumwalts that the etiology of L.Z.’s condition

might never be ascertained. Ex. 11 at 35. Nevertheless, over the months and years following L.Z.’s

two initial hospitalizations, many possible explanations were considered but eliminated. At Cook

Children’s, for example, treaters speculated that L.Z. might have Alpers’ disease9 or a genetic

disorder related to a POLG1 genetic mutation, but test results for both were ultimately negative.

Ex. 11 at 170; Ex. 22 at 89, 1180. An initial fifty-gene epilepsy panel screening was also negative,

meaning that it showed no known pathogenic genetic mutation. Ex. 13 at 134. And August 1, 2014

lab tests for autoimmune conditions that could have triggered encephalopathy revealed no causal

autoantibodies. Ex. 10 at 1–2, filed Aug. 23, 2016 (ECF No. 5-10).

In January 2015, L.Z. was referred to neurologist Cynthia Keator, M.D., who opined that

febrile induced refractory status epilepticus (“FIRES”) was the most accurate characterization of

his epileptic state, though she noted that the actual etiology of this condition was as yet unknown.

Ex. 11 at 140. At a June 2015 visit, Dr. Keator again maintained that L.Z. likely had FIRES of

unknown origin, though she also posited that his condition might be Aicardi-Goutières

9

Alpers’ disease is a rare disease found in young children that results from a nuclear gene mutation. Dorland’s at 528.

It presents with progressive mental deterioration, seizures, motor problems, liver failure, and premature death. Id.

5

syndrome.10 Ex. 13 at 156.

Testing performed in July 2015 revealed no disease-causing mitochondrial mutation or

disorder. Ex. 13 at 127. In October 2015, further genetic testing was conducted in the form of

whole exome sequencing. Ex. 13 at 128. This revealed only that L.Z. carries a variant in his UPF3B

gene. Id. His mother also carries this variant, and while it is associated with X-linked intellectual

disability, Petitioner reached out on his own to Dr. Jozef Gecz, a geneticist at the University of

Adelaide in Australia, who opined (based on Petitioner’s questions) that this genetic variant was

not likely the cause of L.Z.’s condition.11 Id.; Ex. 48 at 4, filed Nov. 3, 2017 (ECF No. 31-2).

A year later (and after this case had been initiated), Dr. Siegler filed a report with the

Vaccine Adverse Event Reporting System (“VAERS”) on September 10, 2016, attributing L.Z.’s

seizure onset to his March 24, 2014 vaccinations. Ex. 17 at 1–2, filed Sept. 20, 2016 (ECF No. 9-

1). In the report, Dr. Siegler described L.Z.’s post-vaccination adverse event as “intermittent

periods of tonic activity of upper and lower extremities with clonus noted in the left lower

extremity.” Id. at 2. He wrote that the adverse event resulted in both “prolongation of

hospitalization” and “permanent disability.” Id. at 3.

II. Witness Testimony

Nicholas Zumwalt

Mr. Zumwalt provided testimony at the hearing consistent with the contents of his affidavit.

Tr. at 4–29. He holds a master’s degree in nursing, works as a professor of nursing at the University

of Tulsa, and is preparing to defend his Ph.D. in nursing, specializing in “parent knowledge and

understanding of suffering in nonverbal children with special needs in a neurological injury.” Tr.

at 5.12

According to Mr. Zumwalt, L.Z. was born one month premature, but was developing

normally until he received the vaccinations at issue. Tr. at 5–6. Prior to vaccination, he had

achieved early developmental milestones such as rolling over and sucking his fists, and he was

able to eat, sleep, and interact well for his age. Id. Significantly, immediately before and after

receiving his six-month vaccinations, L.Z. had no fever or other apparent illness, and L.Z. had no

10

Aicardi-Goutières syndrome is a neuroimmune disorder caused by genetic mutation. A. Takanohashi, et al.,

Elevation of Proinflammatory Cytokines in Patients wth Aicardi-Goutières Syndrome, 80 Neurology 997, 997 (2013),

filed as Ex. A Tab 2, Oct. 27, 2017 (ECF No. 29-2).

11

Although Dr. Gecz’s statement was obtained by Petitioner without the process of a formal evaluation of the sort

that might characterize a treater opinion, neither party contends that the UPF3B genetic variant caused L.Z.’s seizures,

and his view remains unrebutted.

12

Although he testified as a fact witness in his capacity as L.Z.’s parent, Mr. Zumwalt’s statements were exceptionally

detailed and precise, largely due to his own professional experience in the medical field.

6

other immediate or identifiable reaction to the vaccinations. Id. at 6–7.

The evening of April 1, 2014, was “when things changed,” as Mr. Zumwalt described. Tr.

at 8. After L.Z. went down for his evening nap, he did not rouse himself as he usually would, and

was lethargic and unresponsive when Petitioner attempted to wake him. Id. He also did not respond

to direct stimuli. Id. at 8–9. The Zumwalts took him to the ER late that evening, concerned by his

general appearance and his abnormal skin and breathing. Id. at 9.

Petitioner described the events of L.Z.’s first ER visit in a manner consistent with what is

reflected in records from that visit, including L.Z.’s unremarkable CT scan, the series of

medications administered throughout the day on April 2, 2014, before his seizures stopped that

evening, and his two weeks of hospitalization for monitoring and further treatment. See Tr. at 9–

13. Mr. Zumwalt had informed ER treaters that L.Z. had received several vaccinations one week

prior, and recalled that no treater commented on whether they believed his son’s condition to be

vaccine-related. Id. at 11–12. L.Z. was discharged on prophylactic phenobarbital and acyclovir on

April 17th, and by this time, Mr. Zumwalt recalled, his son’s condition had improved significantly:

“we had our smiling baby, happy baby, cuddly baby back.” Id. at 13. He remained in this improved

condition for nine days. Id.

Mr. Zumwalt next described how L.Z. began seizing again on April 26, 2014. Tr. at 13. At

the ER, L.Z. was heavily medicated in an attempt to break his seizures. Id. at 14. Petitioner

described the details of this ER visit and subsequent hospitalization in a manner consistent with

the medical records, recalling that L.Z. was placed in a medically-induced coma for one week, that

treaters later erroneously suspected L.Z. had a rare and fatal mitochondrial disorder known as

Alpers’ disease, and that L.Z. was ultimately discharged without a known etiology for his

condition. Id. at 14–17. In the years since, no specific cause for L.Z.’s seizures has been identified,

despite extensive testing for infectious causes, autoimmune antibodies, and whole exome

sequencing. Id. at 17–18.

Petitioner concluded his direct examination testimony by describing L.Z.’s current

condition. Tr. at 19–22. L.Z. is a quadriplegic, takes food and medication through a tube, cannot

speak, frequently suffers bouts of pneumonia, has kyphosis and scoliosis, and must receive oxygen

through a breathing tube at all times. Id.

During a brief cross-examination, Mr. Zumwalt was questioned about L.Z.’s pre-

vaccination referral to SoonerStart based upon developmental concerns. Tr. at 24–26. Petitioner

did not recall the specific basis for that referral, but characterized any concerns treaters may have

had as minor, opining that such an evaluation was simply suggested “out of caution.” Id.

7

Dr. David Siegler

Dr. Siegler testified at hearing on Petitioner’s behalf and filed one sixteen-page report. Tr.

at 30–65; Ex. 24, filed May 5, 2017 (ECF No. 20-1) (“Siegler Rep.”). Dr. Siegler is a pediatric

neurologist with a practice based in Tulsa, Oklahoma, and he has served as L.Z.’s treating

neurologist since April 3, 2014. Tr. at 31, 33. He testified in this case primarily as a fact witness,

describing his own observations of L.Z.’s clinical course, but also offering an opinion about the

causal role of vaccines in L.Z.’s disorder.

As reflected in his curriculum vitae (“CV”), Dr. Siegler received his B.S. at Stanford

University, followed by his M.D. from the University of Texas Southwestern Medical School in

Dallas. Ex. 62 at 5, filed Sept. 17, 2018 (ECF No. 52-1) (“Siegler CV”); Tr. at 31. He completed

an internship and residency in pediatrics, followed by a residency in child neurology, all at

Stanford. Siegler CV at 4. He is board-certified in pediatric neurology, and currently teaches at

both the University of Oklahoma and Oklahoma State University, while being on staff at two

hospitals in Tulsa. Tr. at 32; Siegler CV at 3. He also runs a solo practice, Child Neurology of

Tulsa. Siegler CV at 1. Much of Dr. Siegler’s practice involves working with patients with

epilepsy, and he spends a significant amount of time reviewing EEGs. Tr. at 32.

Dr. Siegler provided both an overview of L.Z.’s clinical course and an opinion about the

cause of his injury. Based on his experience as L.Z.’s treating neurologist, he opined that L.Z.

developed encephalitis and afebrile status epilepticus as a result of a neurologic inflammatory

cascade triggered by the vaccinations he had received eight days prior, and that this status

epilepticus brought about his ultimate catastrophic brain injury. Tr. at 43–44; Siegler Rep. at 15–

16. He based this both on his review of L.Z.’s test results and on the short time period between

vaccination and onset. Tr. at 41; Siegler Rep. at 15. While he did not discuss a mechanism of

causation in detail, he posited in his report that one of the vaccines L.Z. received on March 24,

2014, “could have induced an inflammatory cascade that culminated in his irreversible neurologic

injuries.” Siegler Rep. at 15.

Dr. Siegler dedicated most of his written report to a detailed overview of L.Z.’s history that

was largely consistent with the medical record. See Siegler Rep. at 1–14. At hearing, Dr. Siegler

began his testimony with a review of L.Z.’s first EEG on April 3, 2014, which showed left side

epileptic activity. Tr. at 33–36. Dr. Siegler opined that L.Z.’s April 4th MRI reading, which was

normal, coupled with his elevated white blood count, suggested the existence of an inflammatory

event occurring at that time in L.Z.’s central nervous system. Id. at 36. Dr. Siegler also discussed

the stark contrast between L.Z.’s April MRI and his May MRI, interpreting the decreased brain

mass revealed in the May reading as evidence of ongoing diffuse brain atrophy. Id. at 39.

Dr. Siegler deemed the FIRES diagnosis mentioned by Dr. Keator to be inapplicable and

8

unhelpful to L.Z.’s case. Tr. at 40–41. By its own terms, FIRES necessarily requires that the patient

have experienced a febrile illness, which L.Z. did not. Id. Furthermore, the term merely describes

a set of symptoms, rather than propose a possible etiology of a patient’s condition. Id.

During cross-examination, Dr. Siegler agreed that L.Z. had some developmental issues

prior to vaccination (including visual tracking issues, head lag, and increased tone). Tr. at 52–54.

While he acknowledged that some of these symptoms could indicate a preexisting neurological

condition, he maintained that L.Z.’s pre-vaccination condition was so markedly different from

afterward that he could not associate the former concerns with the latter, more alarming

constellation of symptoms. Id. Dr. Siegler also acknowledged that, even though testing L.Z.

received in September 2015 had not identified a possible genetic explanation for his seizure

disorder, the list of identifiable genetic mutations associated with epilepsy has expanded in the

past several years, and that he thus has no way of definitively knowing whether L.Z. may have a

genetic mutation that contributed to his condition. Id. at 51.

When pressed about his basis for believing that vaccines caused the onset of L.Z.’s

seizures, Dr. Siegler emphasized that he primarily based his opinion on the close temporal nexus

between vaccination and seizure onset, along with the lack of an identified alternative cause. Tr.

at 56.13

Dr. Lawrence Steinman

Lawrence Steinman, M.D., also testified and filed two reports on Petitioner’s behalf. Tr. at

66–134; Ex. 26, filed July 18, 2017 (ECF No. 24-1) (“Steinman Rep.”); Ex. 64, filed Nov. 12,

2018 (ECF No. 55-1) (“Steinman Supp. Rep.”).14 As shown in his CV, Dr. Steinman received his

B.A. from Dartmouth College and his M.D. from Harvard Medical School, and he completed

residencies in neurology and pediatrics at Stanford University. Ex. 27 at 1, filed July 18, 2017

(ECF No. 24-2) (“Steinman CV”). He has worked as a professor of neurology and pediatrics at

Stanford for the past thirty-eight years, and during that time he has also worked as an attending

physician at Stanford Children’s Hospital. Id.; Tr. at 68–69. He has published over five hundred

peer-reviewed publications on neurology and autoimmune disease. Steinman CV at 5–45; Tr. at

70. He has special expertise in the pertussis toxin, as thirteen of his numerous published articles

specifically pertain to the interaction of pertussis and the immune system (although he has not

13

Respondent also raised issues of Dr. Siegler’s credibility during cross-examination. Specifically, Respondent’s

counsel questioned Dr. Siegler about his relationship with Petitioner’s counsel and the timing of his VAERS report.

Tr. at 47–49. Dr. Siegler acknowledged that he had previously been acquainted with Petitioner’s counsel and had

specifically recommended Mr. Downing to Petitioner. Id. at 47–48. He also acknowledged that he did not submit the

VAERS report until September of 2016—well over two years after the onset of L.Z.’s brain injury—at which point

he was aware that Petitioner was already pursuing litigation, although he explained that during the interim period he

had been attempting to rule out other possible explanations. Id. at 48–49.

14

The second of Dr. Steinman’s two reports was filed one month after hearing, without Petitioner’s counsel first

seeking Respondent’s consent or leave of the Court prior to filing.

9

written on the topic in many years), and he patented certain work related to the development of the

acellular pertussis vaccine. Tr. at 74.

Dr. Steinman dedicated the majority of his testimony to attempting to explain how one or

more of the vaccines L.Z. received on March 24, 2014, could have triggered the onset of his seizure

disorder. He focused upon two in particular: RotaTeq and DTaP. Dr. Steinman noted that the

RotaTeq package insert included a table showing a higher seizure incidence in patients who

received the vaccine over those who received a placebo. Tr. at 81–82 (discussing Ex. 33 at 3, filed

Aug. 2, 2017 (ECF No. 25-7)). Although he conceded that the difference between the reported

seizure incidence rates was not statistically significant, Dr. Steinman nonetheless maintained that

it was meaningful. Id. at 82–83. He did not attempt to explain a mechanism of causation for how

RotaTeq could trigger a seizure, however.15

Next, Dr. Steinman turned to the DTaP vaccine, which he proposed could cause seizures

in two different ways. First, he suggested that the vaccine’s alum adjuvant (included in the vaccine

to increase its immunogenicity) drives a cytokine response that could become pathogenic. Tr. at

84, 98–99. In his written report, Dr. Steinman stated that “alum acts in the inflammosome, a

biochemical compartment within the cell associated with a broad spectrum of diseases including

seizure disorders in infants.” Steinman Rep. at 7. Certain cytokines are understood to induce

fevers, which in turn can trigger seizures—though he acknowledged that this had little relevance

to L.Z.’s case, as L.Z. did not experience a fever at the time of his initial hospitalization and first

seizures (nor did he run a fever at the time of vaccination). Id. at 98–99. Dr. Steinman did not

otherwise clearly explain the sequence of events, running from reaction to adjuvant to cytokine

upregulation, that would ultimately result in the triggering of L.Z.’s seizures.

Dr. Steinman devoted far more time at hearing to discussing a second possible mechanism

of causation involving the DTaP vaccine. In summary, he theorized that the pertussis toxin in the

vaccine causes a specific kind of enzymatic activity, which in turn “kindle[s]” seizures. Steinman

Rep. at 6; Tr. at 84–99. L.Z. received the TDaP vaccine, which contains acellular pertussis. Tr.

at 88. The acellular pertussis component of the DTaP vaccine is intended to protect recipients

against pertussis, an acute and contagious infection of the respiratory tract also known as whooping

cough. Dorland’s at 1421. Although formulated to contain lower amounts of pertussis toxin than

its predecessor version,16 the acellular pertussis vaccine, Dr. Steinman noted, still contains some

pertussis toxin. In addition, the pertussis toxin (produced by the Bordatella pertussis bacterium) is

not only a factor in causing pertussis itself, but has also been implicated, in the context of

15

Dr. Steinman also noted in his written report (although he did not raise the contention at hearing) that the Hib

vaccine’s package insert reflected a possible association with post-vaccination seizures like RotaTeq. Steinman Rep.

at 5–6.

16

The newer “DTaP” vaccine that is more commonly administered today contains acellular pertussis, while the older

“DTP” vaccine was formulated with whole cell pertussis.

10

vaccination, in pediatric neurological conditions (albeit primarily in connection to the whole cell

form of the vaccine). S. Gomez, et al., ADP-Ribosylation Activity in Pertussis Vaccines and its

Relationship to the in vivo Histamine-Sensitisation Test, 25 Vaccine 3311 (2007), filed as Ex. 61,

Sept. 6, 2018 (ECF No. 51-10) (“Gomez”)). The pertussis toxin is also specifically understood to

play a role in ADP-ribosylation—an enzymatic protein modification process (occurring “post-

translational,” or after protein synthesis) important to cell signaling. Steinman Rep. at 7; K.

Edwards, et al., Pertussis Vaccines, in “Plotkin’s Vaccines” 713 (S. Plotkin, et al., eds., 7th ed.

2018); Tr. at 87–89 (citing Gomez).17

Gomez considered the efficacy of the most common test for measuring the degree of

inactivation of detoxified pertussis toxin contained in the acellular form of DTaP: the histamine

sensitization test (“HIST”), an in vivo testing process involving mice. Gomez at 3312. That test is

a “lethal challenge” test,18 in which the pertussis toxin the mice receive from vaccination sensitizes

them to a subsequent anaphylactic shock instigated by histamine challenge. Id. at 3317. Because

HIST is subject to variability and has been deemed unethical, a substitute test has been sought in

the scientific/medical community. Id. at 3311–12.

To identify a possible substitute safety test, Gomez compared HIST results with a

measurement of ADP-ribosylation enzyme activity in the same kinds of vaccines, reasoning that

because this enzyme activity has been hypothesized as “directly responsible for the toxicity”

measured by HIST, measuring it could be an alternative means of assessing vaccine safety. Gomez

at 3311–12. Gomez’s authors concluded that measuring ADP-ribosylation activity corresponded

well to HIST results for DTaP containing genetically-detoxified pertussis toxin, but did not find a

correlation between ADP-ribosylation activity results and HIST results for DTaP containing

chemically-detoxified pertussis toxin (which is more commonly used in vaccines). Id. at 3317.

The authors ultimately concluded that further evaluation was necessary to determine whether

measuring ADP-ribosylation activity accurately reflects the pertussis toxicity level in DTaP. In Dr.

Steinman’s view, Gomez supported his contention that ADP-ribosylation occurs in the presence

of the pertussis toxin, thus confirming that “the pertussis toxin activity is still [occurring] in the

acellular vaccines.” Tr. at 95–97 (discussing Gomez).

Dr. Steinman further maintained that the ADP-ribosylation enzymatic process is also

integral to the triggering of seizures. In support of this, he cited two articles. The first posited that

when seizures are occurring (albeit due to some other cause), the resulting neuronal cell death may

17

Dr. Steinman also cited to four other articles published between 1988 and 1992 as confirming the relationship

between pertussis toxin and neurologic injury, but at hearing conceded that no studies in the past twenty-seven years

have confirmed the assertions of these earlier works. See Steinman Rep. at 6, 9; Tr. at 118–19.

18

A lethal challenge test involves injection of animals with a particular vaccine, followed by inoculation some time

later with a particular toxin that often results in the death of some of the animals. See Gomez at 3312; World Health

Organization Department of Immunization, Vaccines and Biologicals, Manual for Quality Control of Diphtheria,

Tetanus and Pertussis Vaccines, 26–27 (2013), https://www.who.int/biologicals/vaccines/pertussis/en.

11

be attributable in part to the presence of an enzymatic reaction involving poly(ADP-ribose)

polymerase (or “PARP”). Steinman Rep. at 6 (citing L. Chi, et al., Poly(ADP-Ribose) Signal in

Seizures-Induced Neuron Death, 71 Med. Hypotheses 283, 284–85 (2008), filed as Ex. 41, Sept.

6, 2018 (ECF No. 51-5) (“Chi”)). The second suggested that inhibiting PARP decreased seizure

activity. Tr. at 93 (citing S. Wang, et al., Poly(ADP-Ribose) Polymerase Inhibitor Is

Neuroprotective in Epileptic Rat Via Apoptosis-Inducing Factor and Akt Signaling, 18 Molecular

Neuroscience 1285 (2007), filed as Ex. 43, Sept. 6, 2018 (ECF No. 51-7) (“Wang”)).

Wang describes an animal study in which seizures were induced with kainic acid19 in order

to evaluate the impact of seizure activity on activation of PARP in conjunction with a different

substance (3-Aminobenzamide (“3-AB”), a benzoic acid derivative) known to have

neuroprotective properties. Wang at 1285–86. Wang does not expressly equate the enzymatic

process involving PARP with ADP-ribosylation, but Dr. Steinman seems to have concluded that

the two are congruent. Tr. at 94 (characterizing PARP as “another member of this family of

enzymes” that included ADP-ribosylase). Wang’s authors concluded that 3-AB potentially could

assist in the treatment of “hippocampal neuron demise caused by seizures,” although the article

did not discuss pertussis toxin or explain how it might produce seizures with associated neuronal

damage. Wang at 1289. Dr. Steinman nevertheless maintained that Wang supported his contention

that “excessive ADP ribosylation” stimulated by pertussis toxin could be neurologically harmful

(because Wang established that suppression of PARP reduced neuronal harm). Steinman Rep. at

6; Tr. at 94–95.

Dr. Steinman also attempted to explain why the approximately eight-day timeframe

between vaccine receipt and seizure onset was medically appropriate, citing Gomez in support. Tr.

at 96–98. Gomez, he maintained, demonstrated that HIST testing conducted five days after

vaccination of mice with pertussis toxin-containing vaccines revealed evidence of ADP-ribosylase

activity within a day or more later—allowing him to opine that the seizure-inducing properties of

that process could take seven or eight days total. Id. at 97–98; Gomez at 3313. In his one-page

supplemental report, Dr. Steinman further asserted that the pertussis toxin could have a biologic

effect in the body beyond five days. Steinman Supp. Rep. at 1 (citing J. Munoz, et al., Biological

Activities of Crystalline Pertussigen from Bordatella Pertussis, 33 Infection & Immunity 820

(1981), filed as Ex. 65, filed Nov. 12, 2018 (ECF No. 56-1) (“Munoz”)). Dr. Steinman otherwise

confirmed, however, that he could cite no published medical literature in the past thirty years that

had expressly hypothesized that ADP-ribsolyation causes seizure disorders in the context of

vaccines, or that it does so in the timeframe proposed. Tr. at 118–19.

Dr. Steinman provided no additional evidence to explain how any of the vaccines L.Z.

received, individually or in concert, could have caused a seizure disorder that would present

19

Kainic acid is a potent, naturally-occurring neurotoxin found in some types of seaweed. C. Hammond, Cellular and

Molecular Neurophysiology § 10.3 (4th ed. 2015).

12

without fever, and with no other pre-seizure indications of an ongoing immunological reaction.

When questioned about how he could persuasively assert that L.Z.’s seizure disorder was caused

by vaccination, Dr. Steinman placed great importance on the fact that no other potential cause had

ever been identified. Tr. at 100. He did, however, emphasize his view that the pleocytosis noted

from L.Z.’s CSF testing was “smoking gun” proof, because it established the existence of some

inflammatory response at the time L.Z. first presented to the hospital. Id. at 101. He also admitted

(when questioned on cross examination) that some of L.Z.’s pre-vaccination symptoms could be

indicative of a neurologic condition, but added that such symptoms could “mean a lot of things”

not necessarily connected to the post-vaccination seizure activity. Id. at 109–10.

Dr. John Zempel

John Zempel, M.D., Ph.D., was the only witness to appear on Respondent’s behalf. He

testified at hearing and submitted two written reports, maintaining that L.Z.’s vaccinations did not

cause his seizure disorder. Tr. at 135–213; Ex. A, filed Oct. 24, 2017 (ECF No. 28-1) (“Zempel

Rep.”); Ex. C, filed Dec. 12, 2018 (ECF No. 64-1) (“Zempel Supp. Rep.”).

As shown in his CV, Dr. Zempel received his B.S. from the University of Wisconsin-

Madison, followed by his M.D. and Ph.D. (in neurobiology) from Washington University in St.

Louis. Ex. B at 1, filed Oct. 24, 2017 (ECF No. 28-2) (“Zempel CV”). He completed residencies

in pediatrics and child neurology, followed by fellowships in pediatric epilepsy and clinical

neurophysiology. Id. at 2. He now teaches as a professor of neurology and pediatrics at Washington

University School of Medicine, while also working half the year on inpatient services at multiple

hospitals. Id. at 3; Tr. at 137. He estimated that his patient population is approximately 80%

children with highly refractory epilepsy. Tr. at 138. Dr. Zempel is board-certified in neurology

with a special qualification in child neurology, and he has published dozens of articles in medical

and scientific journals, largely focusing on epilepsy and other EEG issues. Id. at 137; Zempel CV

at 3, 5–8. He conceded, however, that his medical research does not directly involve vaccines or

immunology. Tr. at 170–71.

In his hearing testimony and written report, Dr. Zempel made two overarching contentions:

first, that L.Z. likely had some neurologic abnormality before his March 24, 2014 vaccinations;

and second, that Dr. Steinman’s theory of vaccine causation was unsupported by the medical

literature upon which it relies. Tr. at 139–46, 148–52; 158–67; Zempel Rep. at 9–11.

Dr. Zempel began with a discussion of L.Z.’s development before vaccination, finding

evidence of possible neurologic abnormalities even in his first months of life. Tr. at 139–46. He

noted “subtle but persistent concern” from treaters about possible developmental delay,

particularly with regard to his head lag, increased tone, poor visual interaction, and other motor

skills. Id. at 139–41. L.Z.’s head growth had slowed between his two-month and six-month check-

ups, which Dr. Zempel characterized as a concerning indication that L.Z.’s brain was failing to

13

develop at an appropriate pace. Id. at 142–44. Based on these documented concerns, Dr. Zempel

concluded that there was “clear evidence” of neurologic abnormalities before L.Z. received his

six-month vaccinations. Id. at 144–46. He conceded, however, that such evidence would not

necessarily indicate a high epilepsy risk (and therefore was not necessarily predictive of the

outcome L.Z. has experienced). Id. at 146–47.

Dr. Zempel next spoke about his assessment of L.Z.’s clinical course after vaccination and

ultimate diagnosis. He agreed that L.Z. did not have FIRES (given the lack of fever), but stated

that he may have experienced “new onset refractory status epilepticus” (or “NORSE”). Tr. at 154–

55. He clarified that NORSE, like FIRES, is simply a descriptive term, and does not explain the

condition’s etiology. Id. at 157–58. He ultimately opined that the underlying cause of L.Z.’s

epilepsy is as yet unknown, though he speculated that a yet-unidentified genetic component,

infectious agent, or mitochondrial disease may have played a causal role. Id. at 148–52.

Dr. Zempel disagreed with Petitioner’s experts’ conclusion that vaccines may have played

a role in triggering L.Z.’s seizure onset. Tr. at 158–60. He found Dr. Steinman’s theory of causation

too incoherent to analyze or respond to in full, criticizing Dr. Steinman’s method of stringing

together discrete scientific or medical concepts into a “causal stream.” Id. at 168–69. In his report,

Dr. Zempel noted a gap in Dr. Steinman’s logic, stating that the medical literature cited by Dr.

Steinman “does not demonstrate that detoxified pertussis vaccine actually plays a role in seizures

and neuronal death, a key step in claiming causation.” Zempel Rep. at 10. In so maintaining, Dr.

Zempel disputed several of Dr. Steinman’s interpretations of medical literature or other evidence.

For example, he noted that while ADP-ribosylation could theoretically play a role in seizure

activity, key literature cited by Dr. Steinman for this point (like Wang) said nothing at all about

the seizure-inducing capacity of pertussis toxin. Tr. at 167.

Dr. Zempel also took issue with the contention that L.Z.’s medical records established the

existence of an inflammatory event at the time of his hospitalization. Dr. Siegler read the change

between L.Z.’s April and May MRIs as evidence that “the brain abnormalities are not secondary

to status epilepticus but, rather, indicate[] a primary neuro-inflammatory destructive process.”

Siegler Rep. at 14. Dr. Zempel, by contrast, observed that the focal and global brain atrophy visible

in the second MRI was common to refractory status epilepticus, and therefore did not actually

corroborate the contention that L.Z. experienced a primary neuro-inflammatory destructive

process. Zempel Rep. at 9. Rather, the decrease in brain mass between L.Z.’s April and May 2014

MRIs could be attributed to the seizures he experienced in the intervening weeks. Id.; Tr. at 163.

Ultimately, Dr. Zempel characterized L.Z.’s condition as idiopathic in origin. Tr. at 207.

Most of the catastrophic status epilepticus cases he is familiar with never obtain an etiological

explanation. Zempel Rep. at 10–11. Dr. Zempel clarified that he did not rely heavily on his

observations about L.Z.’s possible pre-vaccination neurologic abnormality in reaching this

14

conclusion. Tr. at 211–12. At most, these early signs of abnormality were simply indicia that

something else was going on. Id. He also admitted that L.Z.’s referral for developmental early

intervention services may only have been prophylactic and/or due to his premature birth, but

maintained that L.Z.’s demonstrated hypertonia and fisted hands were nonetheless indicia of pre-

vaccination neurologic abnormality. Id. at 175–76.

In a two-page supplemental report filed in response to Dr. Steinman’s post-hearing

supplemental report, Dr. Zempel again criticized Dr. Steinman’s reliance on medical literature not

specific to the DTaP vaccine or pertussis toxin contained therein. Zempel Supp. Rep. at 1–2. Dr.

Zempel also pointed out that Munoz (published in the early 1980s) spoke only to the effects of the

active pertussis infection, not the impact of detoxified pertussis contained in the acellular DTaP

vaccine. Id. at 2. Thus, “[m]erely showing that the actual pertussis toxin [. . .] has prolonged

biological effects does not establish that the inactivated pertussis vaccine has any causal

relationship to a seizure that occurred eight days after vaccination, well outside the temporal

window demonstrated in epidemiological studies to be associated with seizures.” Id. at 1–2

(emphasis added).

III. Procedural History

As previously noted, this matter commenced with the filing of the Petition and Petitioner’s

supporting affidavit on August 12, 2016. Over the following months, Petitioner filed medical

records in support of his claim. Respondent thereafter filed a Rule 4(c) Report on February 15,

2017, asserting that compensation is not appropriate in this case. Petitioner subsequently filed a

report from Dr. Siegler on May 5, 2017, followed by an expert report from Dr. Steinman on July

18, 2017. Respondent filed a responsive expert report on October 24, 2017. The parties filed their

respective prehearing submissions over the summer of 2018, and a one-day hearing took place on

October 9, 2018.

The parties elected not to file post-hearing briefs. Tr. at 215. However, on November 12,

2018, Petitioner filed an additional report from Dr. Steinman without first seeking leave of the

Court or Respondent’s consent. In the interest of fairness to the parties, I permitted Petitioner to

file this report and gave Respondent the opportunity to submit a supplemental filing of his own.

Respondent accordingly filed Dr. Zempel’s supplemental report on December 12th. This case is

now ripe for decision.

IV. Applicable Legal Standards

A. Claimant’s Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that

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

15

to one of the vaccinations in question and also occurring within a statutorily-prescribed period of

time—or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table

Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; see also

Shalala v. Whitecotton, 514 U.S. 268, 270 (1995) (quoting Section 11(c)(1)(C)(i)); Moberly v.

Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of

Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).20 Petitioner in this case asserts

only a non-Table claim.

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that

leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence

before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s

existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.

476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).

A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the

petition must be supported by either medical records or by the opinion of a competent physician.

Section 13(a)(1).

For a non-Table claim, proof of medical certainty is not required. Bunting v. Sec’y of Health

& Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In such circumstances, a petitioner must

demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a substantial

factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health

& Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human

Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner asserting a non-Table claim must satisfy

all three of the elements established by the Federal Circuit in Althen v. Secretary of Health &

Human Services: “(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.” 418 F.3d

1274, 1278 (Fed. Cir. 2005).

Each of the Althen prongs requires a different showing. Under Althen prong one, 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, the

petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”

Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory

must only be “legally probable, not medically or scientifically certain.” Id. at 549.

20

Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding

authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings

concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,

124 (2003), aff’d, 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-

159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

16

Petitioners may satisfy the first Althen 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 & Human Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009)

(citing Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not

empowered by statute to conclusively resolve what are essentially thorny scientific and medical

questions, and thus scientific evidence offered to establish Althen 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.” Id. at 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 & Human Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844

F.3d 1363 (Fed. Cir. 2017).

In discussing the evidentiary standard applicable to the first Althen prong, many decisions

of the Court of Federal Claims and Federal Circuit have emphasized that petitioners need only

establish a causation theory’s biologic plausibility (and thus need not do so with preponderant

proof). Tarsell v. United States, 133 Fed. Cl. 782, 792–93 (2017) (special master committed legal

error by requiring petitioner to establish first Althen prong by preponderance; that standard applied

only to second prong and petitioner’s overall burden); Contreras, 121 Fed. Cl. at 245

(“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis in

original)); see also Andreu, 569 F.3d at 1375. At the same time, there is contrary authority from

the Federal Circuit suggesting that the preponderance standard applied when evaluating a

claimant’s overall success in a Vaccine Act claim also bears on the first Althen prong. See, e.g.,

Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010) (affirming

special master’s determination that expert “had not provided a ‘reliable medical or scientific

explanation’ sufficient to prove by a preponderance of the evidence a medical theory linking the

[relevant vaccine to relevant injury]”) (emphasis added). Regardless, one thing remains: petitioners

always have the burden of establishing their Vaccine Act claim overall with preponderant

evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations

omitted); Tarsell, 133 Fed. Cl. at 793 (noting that Moberly “addresses the petitioner’s overall

burden of proving causation-in-fact under the Vaccine Act” by a preponderance).

The second Althen prong requires proof of a logical sequence of cause and effect, usually

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

569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956

F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions

and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d

at 1367; 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’”)

17

(quoting Althen, 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 & Human 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”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is

nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be

accepted in its entirety and cannot be rebutted”). 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—including conflicting

opinions among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742,

749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’

conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health &

Human Servs., 100 Fed. Cl. 119, 136 (2011), aff’d, 463 F. App’x 932 (Fed. Cir. 2012); Veryzer v.

Sec’y of Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr.

Apr. 29, 2011), mot. for review denied, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475

F. App’x 765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

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

phrase “medically-acceptable temporal relationship.” Id. 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.” Bazan v.

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

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

can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &

Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012),

aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human Servs., No.

11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review denied (Fed.

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

B. Law Governing Factual Determinations

The process for making determinations in Vaccine Program cases regarding factual issues

begins with consideration of the medical records. Section 11(c)(2). The special master is required

to consider “all [] relevant medical and scientific evidence contained in the record,” including “any

18

diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the

record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,

condition, or death,” as well as “the results of any diagnostic or evaluative test which are contained

in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then

required to weigh the evidence presented, including contemporaneous medical records and

testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is

within the special master’s discretion to determine whether to afford greater weight to

contemporaneous medical records than to other evidence, such as oral testimony surrounding the

events in question that was given at a later date, provided that such a determination is evidenced

by a rational determination).

Medical records that are created contemporaneously with the events they describe are

presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s

health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed.

Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his

contemporaneous medical records, the special master’s decision to rely on petitioner’s medical

records was rational and consistent with applicable law”); Rickett v. Sec’y of Health & Human

Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based

on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly

report their health problems to those professionals; and (iii) medical professionals record what they

are told or observe when examining their patients in as accurate a manner as possible, so that they

are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of

Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10,

2013); Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d

1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately

report the onset of their daughter’s symptoms. It is equally unlikely that pediatric neurologists,

who are trained in taking medical histories concerning the onset of neurologically significant

symptoms, would consistently but erroneously report the onset of seizures a week after they in fact

occurred”).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005

WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical

records are generally found to be deserving of greater evidentiary weight than oral testimony—

especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;

see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d, 968 F.2d

1226 (Fed. Cir.), cert. denied sub nom. Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United

States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that

oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight”)).

19

However, there are situations in which compelling oral testimony may be more persuasive

than written records, such as where records are deemed to be incomplete or inaccurate. Campbell

v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon

common sense and experience, this rule should not be treated as an absolute and must yield where

the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19

(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than

those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733). Ultimately, a

determination regarding a witness’s credibility is needed when determining the weight that such

testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human

Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent, and

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human

Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In

determining the accuracy and completeness of medical records, the Court of Federal Claims has

listed four possible explanations for inconsistencies between contemporaneously created medical

records and later testimony: (1) a person’s failure to recount to the medical professional everything

that happened during the relevant time period; (2) the medical professional’s failure to document

everything reported to her or him; (3) a person’s faulty recollection of the events when presenting

testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v.

Sec’y Health & Human Servs., 110 Fed. Cl. 184, 203–04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.

2014). In making a determination regarding whether to afford greater weight to contemporaneous

medical records over contrary testimony, there must be evidence that this decision was the result

of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present

expert testimony in support of his claim. Lampe v. Sec’y of Health & Human 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 Pharmaceuticals,

Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328,

1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human 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

20

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 (such as the district courts). Daubert factors are usually

employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence

that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors

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

& Human 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”). The flexible use of the Daubert factors to evaluate the

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88

Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not

been employed at the threshold, to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

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, 618 F.3d at 1347 (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. 146 (1997)); see

also Isaac v. Sec’y of Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl.

Spec. Mstr. July 30, 2012), mot. for review denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. App’x

999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339).

D. Consideration of Medical Literature

Both parties relied on significant amounts of medical and scientific literature to support

their respective positions. I have reviewed all of the medical literature submitted in this case,

although my decision does not discuss each filed article in detail. Moriarty v. Sec’y of Health &

Human Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“[w]e generally presume that a special

master considered the relevant record evidence even though he does not explicitly reference such

evidence in his decision”) (citation omitted).

21

ANALYSIS

I. DTaP Vaccine and Pertussis Toxin Contained Therein

Before considering whether Petitioner has met his evidentiary burden under Althen, I will

briefly discuss case law pertaining to allegations that the pertussis toxin contained in certain

vaccines can be causal of injury (since Petitioner’s causation theory focuses in part on the

contention that the DTaP vaccine precipitated L.Z.’s first seizures).

Past Vaccine Program decisions have rejected the notion that the residual amounts of

inactivated/purified pertussis toxin present in the acellular pertussis vaccine can be considered to

cause seizures or encephalopathy to a degree comparable to that of the whole cell version. See,

e.g., Taylor v. Sec’y of Health & Human Servs., 108 Fed. Cl. 807, 820 (2013) (noting that the

modern DTaP vaccine was intended to minimize the amount of toxin in the vaccine as compared

to past versions); Murphy v. Sec’y of Health & Human Servs., No. 05-1063V, 2016 WL 3034047,

at *12 (Fed. Cl. Spec. Mstr. Apr. 25, 2016), mot. for review denied, 128 Fed. Cl. 348 (2016); James

v. Sec’y of Health & Human Servs., No. 09–284V, 2010 WL 4205699, at *11 (Fed. Cl. Spec. Mstr.

Sept. 30, 2010) (acellular form of the pertussis vaccine is much less toxic than the whole-cell

form).

As such decisions reveal, older medical literature establishing that amounts of toxin

contained in versions of the vaccine previously administered are sufficient to be associated with

seizures or other neurologic injuries cannot be applied wholesale to the version of the vaccine

currently administered. Snyder v. Sec’y of Health & Human Servs., No. 07-59V, 2011 WL

3022544, at *30 (Fed. Cl. Spec. Mstr. May 27, 2011) (explaining that applying DTP-related risk

data to DTaP is a “problematic” and misleading extrapolation); see also Sharpe v. Sec’y of Health

& Human Servs., No. 14-65V, 2018 WL 7625360, at *32 (Fed. Cl. Spec. Mstr. Nov. 5, 2018).

Such claims thus often founder on a petitioner’s inability to establish that the amount of pertussis

toxin that may remain in the acellular form of the vaccine is sufficient to provoke neurologic injury.

Murphy, 2016 WL 3034047, at *12, 33. I keep these sound determinations in mind in assessing

the strength of Petitioner’s evidentiary showing.

II. Petitioner Has Not Met His Evidentiary Burden of Proof

I address the Althen prongs relevant and dispositive herein, in order of their significance to

my determination.21

21

Because Petitioner’s claim fails on the first two Althen prongs, I do not include an extended discussion of the third—

since absent a reliable and persuasive theory of causation, satisfaction of this Althen prong (which considers the

timeframe in which a vaccine is alleged to have caused injury) is an insufficient basis for an entitlement award. Caves

v. Sec’y of Health & Human Servs., No. 07-443, 2010 WL 5557542, at *21–22 (Fed. Cl. Spec. Mstr. Nov. 29, 2010),

mot. for review denied, 100 Fed. Cl. 119 (2011), aff’d, 463 F. App’x 932 (Fed. Cir. 2012). But Petitioner did not

succeed in satisfying this prong either. Although the eight-day period from vaccination to onset of L.Z.’s seizure

22

A. Althen Prong One

After careful review of the various theories outlined by Dr. Steinman and the evidence he

cites in support for those theories, I find that Petitioner has failed to offer a medically and

scientifically reliable theory for how any of the vaccines L.Z. received could have caused a seizure

disorder.

1. Pertussis Toxin

The most credible of Petitioner’s proffered theories pertained to the DTaP vaccine. Dr.

Steinman opined that small amounts of the pertussis toxin remaining in the DTaP vaccine could

cause seizures. Steinman Rep. at 6–7; Tr. at 87–98. But this theory relied on a series of

suppositions, not all of which were supported by the filed medical literature or clearly set forth in

persuasive expert testimony.

First, Dr. Steinman asserted that the acellular pertussis vaccine still contains some amount

of the pertussis toxin. Steinman Rep. at 6 (citing Gomez). Reliable literature supports this

statement. See Gomez at 3311 (noting that “some residual [pertussis toxin] activity may likely be

present” in DTaP “because of the limitations of the detoxification processes used”). However,

Petitioner did not establish what levels of residual toxin would be sufficient to cause injury, or that

the amount found in a DTaP vaccine are of that level, instead assuming instead that any amount

would be enough. The fact that larger amounts contained in the whole cell version of the vaccine

may previously have been determined to be associated with injury does not mean that a version of

the vaccine intended to reduce, if not eliminate, that risk is equally problematic. See, e.g., Murphy,

2016 WL 3034047, at *12. And articles like Gomez say nothing at all about what levels of residual

pertussis toxin are problematic. Gomez at 3312 (purpose of study was to propose more effective

and humane test for determining presence of pertussis toxin).

Second, Petitioner proposed that the pertussis toxin is associated with an enzymatic process

(ADP-ribosylation). Steinman Rep. at 6. At hearing, however, Dr. Steinman conceded that much

of the literature offered in support of such contentions was outdated. See Steinman Rep. at 6, 9;

disorder is facially reasonable, and consistent with other cases in which vaccines have been found to cause neurologic

harm, Petitioner’s specific explanation for why such a timeframe was medically reasonable in this case was

unpersuasive. Articles like Gomez (which Dr. Steinman discussed at hearing as supporting a seven- to eight-day post-

vaccination onset) did not actually measure the timeframe in which the pertussis toxin component of a DTaP vaccine

would begin to cause seizures (assuming it could do so in the miniscule amounts contained therein). Instead, the

timeframe Dr. Steinman relied on from Gomez related solely to when the HIST process produced mice death after an

intervening factor (histamine challenge). That factor (which is introduced specifically to measure toxin amounts in a

vaccine) has no bearing on how long the pertussis toxin would take by itself to cause neurologic injury, where an

individual received a DTaP vaccine under normal circumstances.

23

Tr. at 118–19. The more recent literature Petitioner filed was not itself that persuasive for the larger

point it was intended to bulwark. Thus, although Gomez (published in 2007) did somewhat support

Dr. Steinman’s argument, there were limitations to its findings that reduce its overall probative

value. See Gomez at 3317 (noting that pertussis toxin levels for chemically-detoxified DTaP could

not be measured well via ADP-ribosylation enzyme activity).

Ultimately, however, Dr. Steinman’s theory fails in its most central contention: that

“excessive ADP ribosylation can [. . .] play a neuropathic role leading to seizures and to neuronal

death.” Steinman Rep. at 6. Articles like Gomez do not stand for this proposition; on the contrary,

Gomez showed lower ADP-ribosylase enzymatic activity levels in whole cell pertussis than in

seven of the eight acellular varieties tested, despite the fact that whole cell pertussis contains more

toxin than any detoxified pertussis variety, and has been otherwise more credibly associated with

neurologic damage than the acellular version. Gomez at 3314–15 (finding that “the residual

[pertussis toxin] enzymatic activity in [whole cell DTP] was found to be much lower in comparison

to DTaP products, with the exception of [one DTaP variety]”). Other items of literature cited do

not support the concept that this enzymatic process is harmful, but instead involved experiments

in which seizures were already ongoing or had been induced in some other manner. See Wang at

1285, 1288 (seizures triggered by kainic acid); Chi at 284 (discussing observations relating to

ongoing seizures). Thus, the fact that ADP-ribosylation (or PARP, which Dr. Steinman posited,

without much evidentiary support, was comparable) occurred concurrently with seizures did not

necessarily mean that ADP-ribosylation was responsible for the seizure activity itself. See id. Dr.

Steinman otherwise did not demonstrate that any research he performed in the past relating to

pertussis toxin and the means by which it might be theoretically understood to cause seizure has

been confirmed or corroborated in the past ten years (or longer)—especially in light of the present-

day, widespread use of the acellular version of the vaccine.22

2. RotaTeq and Hib

The other proposed means by which the vaccines L.Z. received could have caused his

seizures had even less reliable scientific support than Petitioner’s DTaP theory. Thus, to

substantiate his contention that the RotaTeq or Hib vaccines could have caused L.Z.’s seizures,

Dr. Steinman relied almost exclusively on their respective package inserts. Steinman Rep. at 5–6;

Tr. at 81–83. Yet—as Dr. Steinman effectively conceded—the relevant package insert data did not

strongly support his conclusion. The RotaTeq package insert data showing an increased seizure

22

I also give some weight to Dr. Zempel’s assessment of the persuasiveness of the ADP-ribosylation theory, which

he deemed insufficiently specific and coherent to discuss in depth. See Tr. at 169; Zempel Rep. at 10. However,

because Dr. Zempel did not possess the same level of expertise in immunologic issues as Dr. Steinman, my

determinations on the success of Petitioner’s Althen prong one showing related less to Dr. Zempel’s rebuttal and more

to Petitioner’s ultimate inability (consistent with his burden) to satisfy this prong with preponderant proof arising from

reliable scientific and medical evidence.

24

incidence is not statistically significant. Tr. at 83–83; Ex. 33 at 6 (noting that “seizures reported as

serious adverse experiences occurred in <0.1% (27/36,150) of vaccine and <0.1% (18/35,536) of

placebo recipients (not significant)”). With regard to Hib, the package insert merely discussed a

study of over five thousand infants in which “two definite and three possible seizures” were noted

after receiving a Hib vaccine concurrently with a DTP vaccine, but concluded that no cause and

effect relationship has been established between the Hib vaccine and seizure. Ex. 34 at 18–19, filed

Aug. 2, 2017 (ECF No. 25-7).23 And even if the data listed on either package insert showed a

stronger association with seizures, package inserts are generally afforded very little weight in

Vaccine Program cases as proof of causation. See, e.g., Christiansen v. Sec’y of Health & Human

Servs., No. 08-244V, 2012 WL 6766650, at *12 (Fed. Cl. Spec. Mstr. Nov. 13, 2012).

3. Alum Adjuvant

Dr. Steinman’s argument that the alum adjuvant in DTaP may have played a role in causing

L.Z.’s seizures was equally deficient. See Steinman Rep. at 7; Tr. at 98–99. This contention was

supported with almost no reliable medical literature, beyond one item speaking only generally to

the relationship between the immune system and the central nervous system. See generally R. Bhat

& L. Steinman, Innate and Adaptive Autoimmunity Directed to the Central Nervous System, 64

Neuron 123 (2009), filed as Ex. 46, Sept. 6, 2018 (ECF No. 51-9). And I have regularly found

generalized theories about the purported pathogenic role of adjuvants unpersuasive in past Vaccine

Program decisions, absent proof specific to the injury in question or relevant vaccine. See, e.g.,

Johnson v. Sec’y of Health & Human Servs., No, 10-578V, 2016 WL 4917548, at *8–9 (Fed. Cl.

Spec. Mstr. Aug. 18, 2016). The fact that vaccines are known to stimulate cytokine production (in

part due in some cases to the inclusion of an adjuvant) does not amount to a reliable causation

theory that such stimulation is necessarily disease-causing.

Given the above, I cannot find Petitioner’s proffered causation theories were sufficiently

reliable and persuasive to satisfy Althen prong one.

B. Althen Prong Two

Although Petitioner did not establish a reliable and persuasive causation theory with

sufficient preponderant evidence, his claim would still be unsuccessful even were this not the case,

because the record evidence does not support the conclusion (under the second, “did cause,” Althen

23

In his written report, Dr. Steinman includes a quote purportedly taken from the Hib package insert that states: “In

Study P3T06, within 30 days following any of Doses 1–3 of DAPTACEL + IPOL + ActHIB 10 vaccines, 50 of 1,455

(3.4%) participants experienced a serious adverse event. One SAE of 11 seizure with apnea occurring on the day of

vaccination with the first dose of the three vaccines 12 was determined by the investigators as possibly related.”

Steinman Rep. at 6. This language does not appear in the document filed as the Hib package insert, however (Ex. 34),

and I do not find the quoted excerpt otherwise clearly demonstrative of an association between the Hib vaccine and

seizures.

25

prong) that the vaccines L.Z. received on March 24, 2014 likely caused his seizure disorder

beginning on April 1st, approximately eight days later.

Overall, there are too many factual gaps in the medical record to discern an association

between L.Z.’s vaccinations and his seizures (especially given the sequence of events in this case).

Thus, although seizures can be triggered by a vaccine-induced fever,24 L.Z. unquestionably did not

experience a fever in conjunction with the vaccinations or the first onset of his seizures over a

week later—thereby reducing the likelihood that he was at that time experiencing an underlying

inflammatory event. Ex. 22 at 2522. Indeed, there is no record evidence suggesting that L.Z.

experienced any reaction at all between the March 24th vaccinations and his initial seizures. And,

as explained persuasively by Dr. Zempel, the difference between L.Z.’s MRI reading in April

(which was normal) and May 2014 (which showed substantial brain volume loss) is most likely

attributable to damage caused by refractory status epilepticus seizure activity—not vaccine-

mediated inflammation. Zempel Rep. at 9; Ex. 11 at 47.

No other testing from L.Z.’s initial hospitalization would confirm Petitioner’s theory,

beyond the evidence of pleocytosis based on CSF measurements taken after his April 2nd

hospitalization. This test result does establish central nervous system inflammation, but it was

obtained only after onset of his seizures. Such a temporal sequence makes it difficult to find it

more likely than not that L.Z. was at that time experiencing a vaccine-caused inflammatory process

(especially since, as the second CSF reading indicated, the pleocytosis appeared ultimately to be

somewhat transient).

Respondent did propose that L.Z.’s seizures could be associated with preexisting

developmental problems, but the medical record is inconclusive on this point. The unrebutted

evidence of L.Z.’s developmental problems was piecemeal in nature, and its overall probative

value reduced by Dr. Zempel’s concessions that he could not conclude from it that L.Z. was at

high risk for onset of seizures. See, e.g., Ex. 3 at 61–66; Tr. at 211–12. The fact that L.Z. was

referred for developmental services around the time of his vaccinations has not been shown to be

more than temporally coincidental with his seizures (akin to my finding in this case that L.Z.’s

post-vaccination seizures temporally coincided with vaccination). At most, this category of

evidence provided weak weight against Petitione—not enough to tilt the scale against his claim on

its own, but unhelpful to Petitioner given other, more persuasive evidence discussed above.

Admittedly, Petitioner offered the testimony of one treater, Dr. Siegler, who opined that

L.Z.’s seizures were likely vaccine-caused based on his direct experience with L.Z. Dr. Siegler

was largely a credible witness, who appears to have testified truthfully about his observations in

24

Vaccine Program precedent recognizes that vaccination may trigger a fever, which in turn can trigger seizures. See,

e.g., Tembenis v. Sec’y of Health & Human Servs., No. 03-2820V, 2010 WL 5164324, at *15–16 (Fed. Cl. Spec. Mstr.

Nov. 29, 2010).

26

treating L.Z., based on his firsthand knowledge of L.Z.’s medical history. It is well-established

that treater statements have strong probative value—although special masters are not bound by a

treater’s views. See Section 13(b)(1); Snyder, 88 Fed. Cl. at 746 n.67. Dr. Siegler’s testimony is

accordingly entitled to some deference, and it certainly supports Petitioner’s “did cause”

contentions.

However, several factors lead me to give Dr. Siegler’s testimony less weight than what

Petitioner might urge. First, no contemporaneous treater other than Dr. Siegler seems to have

considered L.Z.’s seizures to have been vaccine-caused.25 Second, Dr. Siegler’s causality views

only came into focus in September of 2016—two and a half years after the first onset of L.Z.’s

seizures, and after this petition was filed. Only then did Dr. Siegler file a VAERS report. While

Dr. Siegler maintained at hearing that in the interim period he had attempted to eliminate other,

more likely causes before considering the possibility of vaccine causation, it is well-established in

the Vaccine Program that contemporaneous medical records—including treater opinions about

possible etiologies—are given more weight than later-in-time statements to the contrary. See

Burns, 3 F.3d at 417. Here, those contemporaneous records memorialize Dr. Siegler’s view in

2014 that Petitioner’s etiology was unlikely to ever be determined. Compare Ex. 11 at 38 with Tr.

at 48–49, 56. Dr. Siegler’s subsequent opinion that L.Z.’s vaccinations produced his seizures loses

some of its probative weight when considered in light of the full medical record (although I also

acknowledge his statement that he revised his opinion only after other etiologies had been

rejected).

At the same time, Dr. Zempel’s testimony about seizure etiology was probative and

significant. Dr. Zempel persuasively established, based on his extensive experience treating

comparable pediatric patients, that the causes of pediatric seizure disorders often remain unknown,

and that the specific facts of this case did not lead him to consider L.Z.’s vaccines as causal. Zempel

Rep. at 10–11. Although in this case many possible explanations, from an identified viral infection

to an underlying genetic cause, were ruled out, a Vaccine Program petitioner does not succeed in

his claim simply by eliminating other possible causes. Althen, 418 F.3d at 1278; Thomas v. Sec’y

of Health & Human Servs., No. 01-645V, 2007 WL 470410, at *25 (Fed. Cl. Spec. Mstr. Jan. 23,

2007) (citing Grant, 956 F.2d at 1149). Rather, a petitioner must affirmatively, and preponderantly,

establish that the specific vaccine received (whether alone or in series with others) was the cause

of the relevant injury. On the basis of this record, the only conclusion I can reach is that L.Z.’s

seizures were most likely idiopathic. See Bazan, 539 F.3d at 1353 (special master’s finding that a

petitioner’s injury was not vaccine-caused implied that the injury had some other cause, but did

not impermissibly heighten petitioner’s burden of proof by requiring petitioner to eliminate

alternative causes).

25

In this regard, I take some pause at Dr. Siegler’s relationship to counsel in this case, and the possibility that his

opinion arose out of a desire to support the litigation (see n.13, above). I have nevertheless given careful consideration

to his testimony, and ultimately give it less weight solely due to factors relevant to the medical record, rather than to

the connection between witness and counsel.

27

At bottom, Petitioner relied heavily on the eight-day temporal proximity between

vaccination and seizure onset. Indeed, Dr. Siegler characterized this as persuasive proof. Tr. at 56.

But temporal association alone does not suffice to demonstrate causation in the Vaccine Program.

McCarren v. Sec’y of Health & Human Servs., 40 Fed. Cl. 142, 147 (1997). As explained by Dr.

Zempel, “[c]ases of catastrophic epilepsy occur throughout infancy and childhood and will

obviously in some cases have temporal overlap with the timing of vaccination.” Zempel Rep. at

10. While it is clear from the record that L.Z.’s condition changed dramatically and irrevocably

soon after vaccination, this sequence alone is not enough grounds to conclude that his seizures

were likely the result of the vaccines.

CONCLUSION

L.Z.’s case is tragic, and Petitioner’s moving testimony made clear that both L.Z. and his

family have been deeply and irrevocably affected by his seizure disorder. In a case such as this—

where a child unquestionably possesses a severe illness, and where the testifying witnesses were

sincere and credible—it is very difficult to resist awarding a petitioner damages. But I am required

to apply the law of the Vaccine Program correctly, rather than based upon my personal sympathies,

and such an application to this case does not lead me to conclude that preponderant evidence

supports Petitioner’s cause of action. I therefore DENY entitlement in this case.

In the absence of a timely-filed motion for review (see Appendix B to the Rules of the

Court), the Clerk shall enter judgment in accord with this decision.26

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Special Master

26

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their

right to seek review.

28