Holmes v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 08-185V
(Filed under seal April 8, 2014)
(Reissued April 24, 2014) †

*************************
*
JAMES HOLMES, * Vaccine Act motion for review; off-table
* case; tetanus and diphtheria vaccination;
Petitioner, * seizure disorder; use of statistical factors;
* treating physicians’ opinions; expert
v. * witness credibility; causation-in-fact not
* established.
SECRETARY OF HEALTH AND *
HUMAN SERVICES *
*
Respondent. *
*
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Richard Gage, Cheyenne, Wyoming, for petitioner. Donald Gerstein, Cheyenne,
Wyoming, of counsel.

Ryan D. Pyles, Trial Attorney, Torts Branch, Civil Division, Department of Justice, with
whom were Tony West, Assistant Attorney General, Mark W. Rogers, Acting Director, Vincent J.
Matanoski, Acting Deputy Director, and Catharine E. Reeves, Assistant Director, all of
Washington, D.C., for respondent.

OPINION AND ORDER

WOLSKI, Judge.

Petitioner James Holmes has moved for a review of Special Master Denise K. Vowell’s
decision that he is not entitled to compensation under the National Vaccine Injury Compensation
program, 42 U.S.C. §§ 300aa-10 et seq. (the Vaccine Act). 1 Petitioner alleges that a tetanus and
diphtheria (Td) vaccination caused him to develop a seizure disorder. Petitioner raises three
objections to the Special Master’s decision to dismiss the petition. First, petitioner challenges

†
Pursuant to Vaccine Rule 18(b) of the Rules of the United States Court of Federal Claims, this
opinion was initially issued under seal to provide the parties the opportunity to object to the
public disclosure of information contained within it. The parties have not requested redactions,
and the opinion is reissued for publication with some minor, non-substantive corrections.
1
Special Master Vowell has since been elevated to the position of Chief Special Master, but is
referenced in this opinion using the position she held when issuing the decision under review.
the Special Master’s reliance on statistical factors in determining causation. Second, petitioner
argues the Special Master did not give the proper weight to treating physicians’ opinions. Third,
petitioner challenges the Special Master’s determination of expert credibility. For the reasons
that follow, the decision of the Special Master is SUSTAINED.

I. BACKGROUND

A. Vaccination and Subsequent Symptoms

Petitioner, James Edward Ivy Holmes II, was born on May 16, 1991. Petitioner’s Exhibit
(Pet’r’s Ex.) 1 at 1. On August 17, 2005, petitioner had a yearly school physical as a fourteen-
year-old in ninth grade. Pet’r’s Ex. 6 at 1. According to the results of the physical, petitioner
was “doing well, [with] no concerns,” and he “denie[d] significant headaches, dizziness, fainting,
motor or sensory losses.” Id. at 1–2. As part of the physical, petitioner received a tetanus and
diphtheria (Td) vaccination. Id. at 1, 4.

On the morning of the next day, August 18, petitioner had a brief seizure, and the
emergency medical services (EMS) arrived to find him lying on the bed. Pet’r’s Ex. 7 at 3. His
older sister reported that while petitioner was sleeping she heard a “thump” and found him with
his eyes rolled back in his head and with his feet moving back and forth, striking each other.
Pet’r’s Ex. 9 at 31, 43. His father had witnessed the tail end of the seizure. Id. at 31. The
seizure was observed to last no longer than three minutes. Id. at 43. En route to the Swedish
American Hospital, petitioner was alert but unable to speak. Pet’r’s Ex. 7 at 3. According to the
prehospital radio report, petitioner was warm and dry post-seizure, id. at 1, and the EMS
personnel narrative stated that his skin color was normal and skin temperature was warm, though
his temperature was not taken, id. at 2–3.

At the Swedish American Hospital emergency department, petitioner was examined by a
primary care physician, Dr. Rose M. Stocker, and the emergency department recorded his oral
temperature as 97.6 degrees. Pet’r’s Ex. 9 at 28. The record also noted that petitioner had
received immunizations the day before, and written under “Diagnosis and Procedure” was
“seizure – s/p Td.” Id. Petitioner was also examined by Dr. Ximena Llobet, to whom his parents
reported that petitioner had no fevers or chills, and no complaints except for pain in his arm from
the tetanus shot. Id. at 31. Doctor Llobet assessed the seizure as a generalized tonic-clonic
seizure, noted that petitioner’s temperature was 97.6 degrees, id., and found him to be alert
though still a “little bit postictal,” id. at 32. Under “Impression,” Dr. Llobet recorded “Seizure,
status post tetanus shot.” Id. Under “Ed Course/Medical Decision Making,” Dr. Llobet wrote, “I
had looked up the tetanus adverse reactions and one of them it listed is seizures.” Id. She then
stated that she called the Vaccine Adverse Event Reporting System, but instead of leaving a
message gave Dr. Stocker the reporting system’s phone number so she could do so. Id.

Petitioner did not have another seizure during two and one-half hours of observation in
the emergency department, and he was released after being scheduled for an outpatient
electroencephalogram (EEG). Pet’r’s Ex. 9 at 32. He returned home and “did not have any
headache, no nausea, no vomiting, no funny taste or smells in his mouth.” Id. at 19. When
petitioner fell asleep in the afternoon, however, his mother saw him experience a second seizure,

2
with “tonic-clonic jerks, eyes rolling back again,” and foaming at the corner of his mouth. 2 Id.
Petitioner’s mother also described three to four minutes of “generalized shaking,” followed by
approximately twenty minute “episodes” where petitioner appeared dazed. Id. at 12. She said he
felt warm, but did not take his temperature. Id. The EMS services reported that petitioner was
postictal at the time of their arrival, and he was brought to the Swedish American Hospital
emergency department at 3:45 p.m. Pet’r’s Ex. 7 at 5.

In an emergency department record created at 4:00 p.m., petitioner was noted to have an
oral temperature of 100 degrees and a rectal temperature of 99.9 degrees. Pet’r’s Ex. 9 at 6.
Under “triage note,” one of the conditions listed was “[f]ever,” and petitioner was given 650 mg
of Tylenol and 750 mg of Dilantin. Id. The nursing care record confirmed both the rectal
temperature of 99.9 degrees and Tylenol dosage, and also noted that he had a “swollen shoulder
from vaccinations yesterday.” Id. at 9–10. Doctor Anthony Schultz evaluated petitioner upon
his arrival at the emergency department, noting that he “showed temperature 100 [degrees]” and
had a rectal temperature of 99.9 degrees. Id. at 12. Doctor Schultz observed a “small
inflammatory reaction at the site of the tetanus shot” which was not warm. Id. at 13. In his
record, Dr. Schultz reported that he found no redness, axillary lymphadenitis, or axillary lymph
node swelling. Id. Under the “Impression” portion of the record, Dr. Schultz wrote: “Seizure by
history, most likely secondary to tetanus toxoid immunization.” Id.

Subsequently, petitioner received an evaluation from Dr. Wen-Ho Yang, who recorded
petitioner’s temperature as 100 degrees. Pet’r’s Ex. 9 at 20. Noting that petitioner had received
a tetanus shot on his left deltoid the day before and reported soreness in his left arm, id. at 19, Dr.
Yang observed that his left deltoid was “warm to touch, slightly indurated and tender to touch,”
id. at 20. Doctor Yang, however, did not observe any abscesses or areas of redness. Id. From
petitioner’s physical examination, Dr. Yang recorded the impression that “[g]iven his recent
history of a tetanus vaccine, he could well have had a reaction towards the vaccine components,
probably horse serum.” Id. at 21.

A computed tomography (CT) scan for fractures and intracranial processes was negative.
Pet’r’s Ex. 9 at 21. Petitioner also received an echocardiogram, yielding results in the normal
range. Id. at 26. In his discharge summary, Dr. Saurabh Vaish reported that petitioner did not
have any seizures in the hospital and did not develop “any fevers, neck stiffness, nausea or
vomiting,” id. at 17–18, and he discharged petitioner with a final diagnosis of “new onset
seizures.” Id. at 17.

Petitioner went to neurologist Dr. Philip Miner for a follow-up neurological consultation
on September 6, 2005. At this initial visit, Dr. Miner noted that petitioner had two generalized
seizures and that he was “afebrile at the time.” Pet’r’s Ex. 8 at 1. Doctor Miner’s assessment
was that petitioner had “[s]econdarily generalized seizures of unclear etiology.” Id. Petitioner’s
mother expressed the concern that he did not “look quite right” since he had been on the
Dilantin, and Dr. Miner ordered a discontinuation of Dilantin and the beginning of treatment

2
Petitioner’s mother reported that the second seizure occurred around 1 p.m., Pet’r’s Ex. 9 at 19,
but the EMS narrative stated that a “Medical/Illness call was received at 15:29.” Pet’r’s Ex. 7 at
5.
3
with Depakote. Id. On September 15, 2005, a brain Magnetic Resonance Imaging (MRI) exam
produced normal results, with no intracranial mass or other abnormalities. Id. at 4. At a visit to
Dr. Miner on September 28, 2005, petitioner’s mother reported no new seizures, but said
petitioner seemed “very forgetful.” Id. at 5. Doctor Miner also observed a macular-papular rash
over petitioner’s torso, neck, and extremities, and he prescribed Trileptal to replace Depakote.
Id.

On October 7, 2005, petitioner experienced two seizures and went to the Swedish
American Hospital emergency department at 9:45 a.m. 3 Pet’r’s Ex. 9 at 56. These seizures
occurred on the day he was to begin the Trileptal, after stopping the use of Dilantin and
Depakote. Id. at 59. During a visit to Dr. Miner on November 10, 2005, Dr. Miner observed a
macular rash over petitioner’s entire torso, which had faded and apparently did not bother
petitioner. Pet’r’s Ex. 8 at 11. After assessing his other symptoms, Dr. Miner diagnosed
petitioner with epilepsy. 4 Id. At a December 10, 2005 visit, Dr. Miner repeated his assessment
of “[s]econdarily generalized epilepsy.” Id. at 15.

Petitioner remained on Trileptal and did not have another seizure until May 14, 2006. On
that day, petitioner had a full-body seizure in his sleep that lasted approximately two to three
minutes, Pet’r’s Ex. 9 at 83, 89, after failing to take his seizure medicine the day before, id. at 84.
Doctor David E. Miller noted petitioner’s history of seizures and headaches and concluded that
he had an acute breakthrough seizure. Id. at 83–84. On May 5, 2007, petitioner experienced
another seizure, after skipping two days of seizure medications. Pet’r’s Ex. 12 at 3. At 4:15 p.m.
on May 31, 2007, petitioner went to the emergency room again after having a full-body seizure
of approximately two minutes, his second seizure of the day. Id. at 33.

B. The Petition and Hearing Before the Special Master

On March 18, 2008, when petitioner was still a minor, his mother, Christina Loudermilk,
filed a petition for vaccine compensation on his behalf. Pet. at 1. 5 The petition alleged that
petitioner’s seizures and neurologic injuries were caused by his Td vaccination on August 17,
2005. Id. Attached to the petition were various medical records for petitioner such as
petitioner’s prenatal and birth records, vaccination records, newborn records, and pediatric
records; the ambulance reports from petitioner’s seizure incidents; petitioner’s hospital records,
and the neurology report from Dr. Miner. See id., Exs. 1–9.

3
The date was mistakenly written as October 11 in Dr. Miner’s record of petitioner’s visit on
November 10, 2005. Pet’r’s Ex. 8 at 11.
4
In a December 18, 2006 record, Dr. Miner recorded the assessment of “[e]ncephalopathy,”
Pet’r’s Ex. 8 at 26, Pet’r’s Ex. 11 at 10, which is reported in only one subsequent record. See
Pet’r’s Ex. 11 at 15. The other records concern primarily epilepsy. See Pet’r’s Ex. 11 at 13, 18,
21, 24, 26, 28.
5
The case was recaptioned as brought by James Holmes once he reached the age of majority.
See Order (July 6, 2010).
4
 Within two months, petitioner also filed a neuropsychological evaluation from a clinical
pediatric neuropsychologist, Lisa Mottram, Ph.D. Pet’r’s Ex. 10. The report included results
from a psychoeducational evaluation, showing cognitive deficits such as slowed mental
processing speed, verbal memory and learning difficulties, and working memory difficulties. Id.
at 5–6. The report also suggested that these deficits were the result of petitioner’s seizure
disorder. Id. at 5.

1. The Expert Witnesses’ Reports

In addition to more of his medical records, see Pet’r’s Exs. 11–13, petitioner also filed
expert reports from Dr. Marcel Kinsbourne, scientific articles, and information on tetanus toxoid.
See Pet’r’s Exs. 14–20. 6 In his initial expert report, Dr. Kinsbourne posited that the Td
vaccination triggered complex febrile seizures that caused petitioner’s epilepsy, resulting in
cognitive impairments. Pet’r’s Ex. 14 at 3. According to Dr. Kinsbourne, petitioner’s 99.9
degree temperature after the second seizure represented a low-grade fever, and the “vigorous
local inflammatory reaction at the vaccination site indicate[d] the local presence of an intense
immune reaction, involving proinflammatory cytokines.” Id. at 2. Doctor Kinsbourne wrote that
the cytokines “could enter the blood stream and cause seizures, through the intermediary effect
of fever and/or by directly provoking epileptogenesis.” Id. at 2–3. Citing drug evaluations
issued by Micromedex and the opinions of petitioner’s treating physicians, Dr. Kinsbourne
attributed the seizures to the tetanus vaccination and argued that petitioner’s medical records did
not reveal a “potential alternative causal or provoking event.” Id. at 3. In support of his
argument, Dr. Kinsbourne cited a 1987 medical journal article (the Annegers study) 7 that found
that the risk of epilepsy was greater after complex than simple febrile seizures. Pet’r’s Ex. 14 at
3; see Pet’r’s Ex. 15 at 1 (“The risk ranged from 2.4 percent among children with simple febrile
convulsions to 6 to 8 percent among children with a single complex feature -- i.e., focal or
prolonged seizures or repeated episodes of febrile convulsions with the same illness. For
children with any two of the complex features, the risk was 17 to 22 percent.”).

Respondent’s report was filed on September 4, 2009, supported by an expert report from
Dr. Shlomo Shinnar and copies of medical and scientific literature filed on a compact disc. See
Resp’t’s Rep., Exs. A– B; Resp’t’s Notice of Intent to File on Compact Disc (Sep. 4, 2009),
Docket No. 31; Resp’t’s Exs. A1–A26. Relying on Dr. Shinnar’s report, respondent challenged
Dr. Kinsbourne’s opinion and argued that petitioner failed to establish that the Td vaccination
was causally connected to a seizure disorder or to lasting neurological decline. Resp’t’s Rep. at
6–7. In his report, Dr. Shinnar disagreed with Dr. Kinsbourne’s opinion that petitioner had
experienced complex febrile seizures, noting that the minimum threshold for a fever in the
relevant studies was usually 101 degrees. Resp’t’s Ex. A at 4. Though Dr. Shinnar agreed that
cytokines could produce seizures, he explained that an association with a febrile illness required
the actual presence of a fever. Id. at 5. Doctor Shinnar further noted that various studies of

6
The qualifications and experience of Dr. Kinsbourne and of respondent’s expert, Dr. Shinnar,
are detailed below in the accounts of their respective testimony.
7
See Pet’r’s Ex. 15 (John F. Annegers et al., Factors Prognostic of Unprovoked Seizures after
Febrile Convulsions, 316 NEW ENGL. J. MED. 493-98 (1987)).
5
febrile seizures considered children up to age twelve at most (and usually under age ten), but
petitioner was age fourteen at the time of his first two seizures. Id. The usual latency to develop
epilepsy was eight to eleven years after prolonged febrile seizures, Dr. Shinnar argued, and
petitioner’s second set of seizures were only two months after his vaccination. Id. At age
fourteen, Dr. Shinnar noted, petitioner was at a common age for the development of seizure
disorders, and a significant number of epilepsy syndromes begin in adolescence. Id. at 6. Doctor
Shinnar concluded that petitioner’s seizures were not the result of a vaccine-related injury and
did not meet the criteria for complex febrile seizures. Id. at 7.

Doctor Kinsbourne responded with a “supplementary report” filed on November 23,
2009. Pet’r’s Ex. 18. He again referenced the Micromedex evaluations as showing that tetanus
toxoid can cause seizures, and alleged, with no citation, that petitioner’s “temperature was
recorded as 100 degrees axillary” in the emergency room the day of his initial seizures. Id. at 1.
This temperature would “correspond[] to an oral temperature of 101 degrees,” and would thus
“meet Dr. Shinnar’s epidemiologically based arbitrary cutoff point for fever.” Id. Doctor
Kinsbourne contended that this fever, as well as petitioner’s “‘small inflammatory reaction’ at
the vaccination site,” which included a “‘swollen left shoulder,’” evidenced “ample cytokine
production” to support his causation theory. Id. at 2 (quoting Pet’r’s Ex. 9 at 9, 13). He
recounted the medical records in which three treating physicians associated the initial seizures
with the tetanus vaccine. Pet’r’s Ex. 18 at 2 (citing Pet’r’s Ex. 9 at 13, 21, 32). And he criticized
Dr. Shinnar for failing to “explain the biological mechanism by which” the vaccine could result
in seizures when recipients are age ten or twelve, but cease doing so for fourteen-year-olds. Id.
Petitioner’s expert also pointed to medical records supporting the diagnosis of encephalopathy,
and to the Micromedex evaluations noting reported associations between encephalopathy and
tetanus toxoid. Id. (citing Pet’r’s Ex. 16 at 4, Ex. 8 at 26, Ex. 11 at 10, Ex. 10 at 5). He
disagreed with Dr. Shinnar’s interpretation of the neuropsychological testing report written by
Dr. Mottram, and noted that respondent’s expert “did not offer a specific alternative causation.”
Id. at 3.

Doctor Shinnar replied in a “supplemental report,” filed on January 27, 2010. Resp’t’s
Ex. C. He criticized the Micromedex document for not distinguishing between young children,
for whom seizures are unquestionably associated with tetanus vaccines, and older children or
adolescents, for whom no data associates the two. Id. at 1. He cites “the Academy of Pediatrics
Red Book[,] which is an authoritative source and does distinguish between those reactions seen
in children and those seen in adolescents.” Id.; see also Resp’t’s Ex. D. Doctor Shinnar disputed
that petitioner had a fever when he suffered the initial seizures, and reiterated that a person as old
as petitioner was at the time could not have a febrile seizure. Resp’t’s Ex. C at 2. He stressed
that no literature supports Dr. Kinsbourne’s “claim of a complex febrile seizure as a result of
[Td] immunization occurring in a 14 year old adolescent.” Id. at 3.

2. The Special Master’s Hearing

On June 30, 2010, Special Master Vowell held a hearing on the petition for
compensation. Doctor Kinsbourne testified as the expert for petitioner, and Dr. Shinnar did so
on behalf of the Secretary. Doctor Marcel Kinsbourne completed his undergraduate and medical
education at Oxford University in England, where he also took the examination for Membership

6
of the Royal College of Physicians and lectured in experimental and neurological psychology.
Sp. Mstr. Tr. at 6–7. In 1967, Dr. Kinsbourne became a professor of neurology and psychology
and the chief of the Division of Child Neurology at Duke University. Id. at 7–8. He then
became a senior staff physician at the Hospital of Sick Children in Toronto and a professor at the
University of Toronto, in 1974. Id. at 8. In 1980, after twenty-five years of a general neurology
practice, Dr. Kinsbourne specialized in developmental neurological disorders, such as behavioral
disorders, cognitive disorders, and mental retardation. Id. He became a chief of the division of
behavioral neurology at the Eunice Kennedy Shriver Center in Boston and, in 1995, became a
professor in the psychology department at the New School, teaching and conducting research
with a laboratory of eight-to-ten graduate students in psychology. Id. at 9. Doctor Kinsbourne
has published extensively in medical and scientific journals, with his more recent work
concerning autism and attention-deficit/hyperactivity disorder. Id. at 10.

Doctor Kinsbourne began his testimony with a focus on the tetanus toxoid component of
the Td vaccination. Sp. Mstr. Tr. at 12. Referring to a drug evaluations document from
Micromedex Healthcare, see Pet’r’s Ex. 16, Dr. Kinsbourne identified convulsions and
encephalopathy as some of the neurological complications that result from tetanus toxoid, as well
as the general side effect of seizures. Sp. Mstr. Tr. at 13. Doctor Kinsbourne next turned to
petitioner’s medical records from the day of his first two seizures, noting the opinions of treating
physicians Drs. Schultz, Yang, and Llobet that petitioner’s seizures were related to his Td
vaccination. Id. at 15–17. Pertaining to the temporal relationship prong of Althen, Dr.
Kinsbourne next testified that a seizure occurring within 24 hours of the Td vaccination
“wouldn’t have to be within that time frame, but it would typically be.” Id. at 18.

Doctor Kinsbourne submitted that petitioner’s “swollen shoulder from vaccination” was a
“local inflammation caused by the vaccination mediated by what are called pro-inflammatory
cytokines.” Sp. Mstr. Tr. at 20. In response to the Special Master’s question about the term
“mediated,” Dr. Kinsbourne clarified that “[t]he chemistry is more complex” but “cytokines are
an essential part of [the inflammation].” Id. Doctor Kinsbourne testified that the cytokine
Interleukin One beta (IL-1 beta) was known to cause fever and seizures, and that a study had
shown that IL-1 beta could cause seizures without the presence of fever. Id. at 21–23 (citing
Resp’t’s Ex. A24). Though Dr. Kinsbourne conceded that the study was based on rats and did
not reflect temperatures in humans, he argued that the causal link between IL-1 beta and seizures
had been “documented massively.” Id. at 23–24. Referring to medical records noting that
petitioner was “warm” at the time of his first two seizures, Dr. Kinsbourne explained that it was
“not uncommon” for someone’s temperature to fluctuate. Id. at 28, 31, 33.

Doctor Kinsbourne then addressed the question of whether petitioner’s two seizures on
August 18, 2005, were focal seizures. He interpreted the EMS record notation, “[e]n[]route
p[atien]t alert but unable to speak to us,” Pet’r’s Ex. 7 at 3, to mean that petitioner’s first seizure
originated from the left hemisphere of the brain, where it affected speech functions. Sp. Mstr.
Tr. at 33–34. Doctor Kinsbourne reconciled this interpretation with observations of convulsions
on both sides of petitioner’s body by explaining that petitioner could have experienced a focal
seizure that “had gotten to the bilateral stage” when it was witnessed by his family. Id. at 36–37.
Regarding the second seizure, Dr. Kinsbourne noted that petitioner “looked up and rightward” at

7
the onset of that seizure, indicating “excessive neurologic activity in the left hemisphere.” Id. at
39–40.

A complex febrile seizure, Dr. Kinsbourne explained, is characterized by three features:
“partial onset, which is the same as focal”; prolonged duration of more than ten or fifteen
minutes; and multiple seizures in “a single illness episode generally in a 24 hour period.” Sp.
Mstr. Tr. at 48–49. Citing the Annegers study, Dr. Kinsbourne stated that children with “a single
complex feature” have a six to eight percent risk of unprovoked seizures after febrile convulsions
and children with “any two of those three features” had a seventeen to twenty-two percent risk.
Id. at 51. For children with all three features, the risk was forty-nine percent, though Dr.
Kinsbourne noted that he could not establish that petitioner’s seizures were sufficiently
prolonged. Id. When asked if he attributed “the onsetting then subsequent seizure disorder of
[petitioner] to his tetanus vaccination,” Dr. Kinsbourne replied that he did. Id. at 53. In Dr.
Kinsbourne’s opinion, petitioner “suffered a brain injury consequence on the series of events
unleashed by the vaccination and the febrile complex seizure which followed.” Id. at 54.

On cross-examination, Dr. Kinsbourne was asked about his experience clinically treating
patients with seizure disorders (which ceased around 1980); about the subject matter of his
publications (none of which was on seizures or epilepsy); and about the percentage of his income
which was due to expert testimony (which was about fifty percent, most of which came from
vaccine cases). Sp. Mstr. Tr. at 55–57. Turning to the substance of his expert opinion, Dr.
Kinsbourne stated that his opinion was “dependent on [petitioner] having had a complex febrile
seizure.” Id. at 57. When asked if he meant that, without the presence of a fever, the vaccine
could not have caused petitioner’s injury, Dr. Kinsbourne replied: “I wouldn’t dream of saying
that without fever the vaccine wouldn’t have caused it because I don’t know that. Might have
caused it, but I’m not presenting that case to the court at this time.” Id. at 57–58. He clarified
that “the opinion [he was] presenting is predicated on” petitioner’s first two seizures “meeting
with the definition of febrile complex seizure.” Id. at 58.

In the context of populations in epidemiological studies, Dr. Kinsbourne noted that “the
lower level for recognized fever would be 100.4 degrees for rectal temperature,” 99.4 degrees for
oral temperature, and 98.4 degrees for axillary temperature. Sp. Mstr. Tr. at 59–60. In his
opinion, however, there was a continuum with “enormous variation” of elevated temperatures at
which people would be susceptible to seizures. Id. at 60. Noting the variations in a person’s
temperature throughout the day, Dr. Kinsbourne stated that temperatures tend to be higher in the
afternoon and lower in the early morning and evening. Id. at 61. He agreed with respondent’s
counsel that petitioner’s oral temperature of 97.6 degrees after the first seizure was not febrile.
Id. at 62. Regarding petitioner’s temperature at the time of the second seizure, Dr. Kinsbourne
had claimed in his report that petitioner had an axillary temperature of 100 degrees. Id. at 63.
After reviewing a copy of the medical record, Dr. Kinsbourne conceded that he had mistaken an
oral temperature of 100 degrees for axillary temperature. Id. Doctor Kinsbourne nonetheless
maintained his opinion that petitioner had experienced febrile seizures, id. at 65, and that
temperature readings taken after the seizure would not reflect temperature during the seizure, id.
at 66.

8
 Subsequently, the cross-examination focused on whether petitioner would be considered
a child and part of the population for which there were epidemiological studies. Though Dr.
Kinsbourne agreed with respondent’s counsel that petitioner “was an adolescent at age 14,” he
also stated that “child” would encompass an age range “certainly to age 15 and probably to age
18.” Sp. Mstr. Tr. at 67–68. Referring to respondent’s exhibit D, “the Red Book,” respondent
counsel asked if it would indicate that seizures from a tetanus vaccination were “not an issue in
the adolescent population.” Id. at 70. Doctor Kinsbourne responded that “the idea that it would
be less of an issue in adolescents than it is in other ages of childhood I think is actually absurd,”
noting that seizure disorders tend to emerge during adolescence. Id.

At the end of cross-examination, the Special Master asked Dr. Kinsbourne to explain
petitioner’s exhibit 16, a document from a Micromedex service subscription that described
“important aspects” of the tetanus toxoid vaccine. Sp. Mstr. Tr. at 73–74. Doctor Kinsbourne
testified that, to his knowledge, the tetanus toxoid was “no different” from the tetanus in the Td
vaccination. Id. at 74. He agreed with the Special Master that horse serum was no longer used
in tetanus toxoid and that one of petitioner’s treating physicians, Dr. Yang, was incorrect in
referring to horse serum as a possible cause of petitioner’s seizures. Id. at 75–76.

Upon redirect examination by petitioner’s counsel and cross-examination by respondent’s
counsel, Dr. Kinsbourne repeated his assessment that the EMS record describing petitioner as
“warm” referred to elevated temperatures. Sp. Mstr. Tr. at 98. In response to questioning by
respondent’s counsel and the Special Master, Dr. Kinsbourne also clarified his opinion of the
difference between seizure disorder in infants, adolescents, and adults. Id. at 106. In his
opinion, the probability of complex febrile seizures fluctuates with age but did not imply a
qualitative difference. Id. at 107–08. Doctor Kinsbourne stated that he “[did]n’t see the big
difference between 10[-] and 14-year-olds,” but he “can’t really answer [the] question” of
whether there was a significant difference in probability of unprovoked seizures. Id. at 109–10.

Doctor Shlomo Shinnar is a pediatric neurologist working at Montefiore Medical Center
in New York City. Sp. Mstr. Tr. at 120. He earned his undergraduate degree at Columbia
College and received both an M.D. and a Ph.D. in neuroscience from the Albert Einstein College
of Medicine. Id. Doctor Shinnar is a professor of neuroscience research and also the director of
comprehensive epilepsy management at Montefiore. Id. at 121. He particularly specializes in
treating children with seizure disorders and divides his time between teaching, research, and
personally treating patients. Id. As the senior neurologist for the Montefiore clinic, id. at 122–
23, Dr. Shinnar’s patients reflect a broad range of neurological disorders, with about two-thirds
of them having epilepsy and many having suffered febrile seizures. Id. at 122. Though his
patients usually range in age from newborn to twenty-one years, he typically follows his seizure
patients into their adulthoods. Id. at 123. Doctor Shinnar has published over 150 peer-reviewed
papers, over 100 chapters of review articles, and over 250 abstracts. Id. at 122. The majority of
his publications have focused on seizures, with many on febrile seizures in particular. Id.

Doctor Shinnar testified that in his opinion the Td vaccination petitioner received had no
causal relationship to petitioner’s first two seizures on August 18, 2005, or to petitioner’s
subsequent epilepsy. Sp. Mstr. Tr. at 124–25. Doctor Shinnar explained that his main
disagreement with Dr. Kinsbourne’s assessment that petitioner suffered complex febrile seizures

9
was that the evidence did not show that petitioner’s seizures fit the definition of febrile. Id. at
126. In support of his opinion, he referenced scientific studies and medical literature which
reported that febrile seizures rarely began after the age of seven years (only 1–2 percent of
cases), and noted that his research discovered only one child as old as nine years. Id. at 127–29.
He testified that the overwhelming majority of children (85 to 90 percent) who suffered febrile
seizures were younger than three years old, id. at 128, with a median age of eighteen months. Id.
at 129. According to Dr. Shinnar, the tail end of an exponential distribution may rarely extend to
an eight- or nine-year-old, but not to older children. Id.

In further support of his opinion, Dr. Shinnar testified that febrile seizures by definition
occur in the context of a febrile illness which “implies that you have a sustained temperature . . .
that could take weeks or many days,” and there is no evidence that petitioner had such an illness.
Id. at 135; see id. at 146. At the time of the initial seizure, the EMS report stated that petitioner’s
skin temperature was warm, see Pet’r’s Ex. 7 at 2–3, but the emergency room report recorded his
temperature as 97.6 degrees. See Pet’r’s Ex. 9 at 28. Doctor Shinnar testified that “warm skin is
a completely unreliable measure of temperature,” id. at 137, and that the recorded temperature
would have revealed a fever even after the seizure if the seizure had occurred in the context of a
febrile illness. Id. at 134–35; see id. at 180. Petitioner’s highest recorded temperature was 100
degrees, which Dr. Shinnar argued was below febrile and would be too low to cause any child to
suffer a seizure (much less a fourteen-year-old, who is beyond the age for which fever may
provoke a seizure). Id. at 133–34; see id. at 147. Thus, because of petitioner’s age and because
there was no evidence of a fever or febrile illness, Dr. Shinnar concluded petitioner did not have
febrile seizures. Id. at 136.

Doctor Shinnar disagreed with Dr. Kinsbourne’s suggestion that cytokines released by
the vaccine caused petitioner to have a fever. While Dr. Shinnar acknowledged that the IL-1
beta cytokine was typically associated with redness and swelling around a wound, he contended
that one could not infer from mere swelling that a fever had been induced --- the latter required
enough cytokines to cause a systemic febrile reaction, which is evidenced by the fever itself. Sp.
Mstr. Tr. at 143–45, 180. He also stated that a person must be in “the age of susceptibility” for
the IL-1 to cause a fever that would result in a seizure, and that age fourteen is not in that range.
Id. at 147.

Doctor Shinnar further testified that in his opinion petitioner’s two seizures on August 18
did not result in his epilepsy and would not necessarily have “adversely impact[ed] [his] future
course” because such seizures do not increase a person’s risk for having further seizures or
developing epilepsy. Sp. Mstr. Tr. at 149–51. According to Dr. Shinnar, a seizure would have to
be prolonged for thirty minutes or more in order to cause a brain injury which could then result
in epilepsy. Id. at 153; see id. at 155. Whether febrile or not, the duration of the seizure is what
causes lasting injury to the brain, he explained, and seizures as brief as petitioner’s initial ones
would not cause epilepsy. Id. at 197–201. Additionally, Dr. Shinnar opined that it was not
epilepsy but rather the medication petitioner was taking that caused the latter’s cognitive
impairment such as sleepiness and memory loss. Id. at 163–64. During cross-examination by
petitioner’s counsel, Dr. Shinnar repeated his opinion that petitioner probably had an underlying
seizure disorder before August 18, 2005, which had not previously been manifest. Id. at 174–77.

10
He did not think the vaccination caused the epilepsy, and noted that “unclear etiology is the rule
for two[-]thirds of child onset epilepsy.” Id. at 177.

C. The Special Master’s Decision Denying Compensation

On April 26, 2011, the Special Master issued a decision denying compensation, finding
that petitioner failed to establish that the vaccination caused his injury. Holmes v. Sec’y of HHS,
No. 08-185V, 2011 WL 2600612, at *1–2 (Sp. Mstr. April 26, 2011). The Special Master based
this conclusion on “problems with the factual and medical underpinnings of the opinions” of
petitioner’s expert, whom the Special Master found less persuasive than respondent’s expert. Id.
at *2.

The Special Master identified the primary factual dispute to have been whether
petitioner’s two initial seizures the day after his Td vaccination were complex febrile seizures.
Id. at *8. Petitioner had the first seizure the morning of August 18, 2005, and while being treated
at the Swedish American Hospital emergency department his temperature was recorded to be
97.6 degrees. Id. at *6–7. After his release from the hospital, petitioner had another seizure later
that afternoon. The emergency department recorded a rectal temperature of 99.9 degrees and
oral temperature of 100 degrees fifteen minutes after his arrival. Id. at *7.

In Dr. Kinsbourne’s opinion, petitioner had a fever at the times of both initial seizures,
thus satisfying the criteria for complex febrile seizures. Holmes, 2011 WL 2600612, at *8.
Doctor Kinsbourne posited that the vaccine caused an inflammation at the injection site, Sp.
Mstr. Tr. at 20, which led to the release of the cytokine IL-1 beta, Sp. Mstr. Tr. at 21. According
to Dr. Kinsbourne, the presence of IL-1 beta provoked complex febrile seizures that caused
petitioner’s epilepsy. Holmes, 2011 WL 2600612, at *14–15.

The Special Master found, however, that petitioner’s expert was mistaken in believing
that petitioner’s August 18, 2005 seizures were febrile. Holmes, 2011 WL 2600612, at *8–10.
Concerning the first seizure, Dr. Kinsbourne in his initial report found the presence of a fever
based on the ambulance record describing petitioner’s temperature as warm, and his belief that
petitioner’s mother stated petitioner “felt hot” during this seizure. See id., at *9; Pet’r’s Ex. 14 at
1–2. But the Special Master noted that “[t]he evidence indicates that [petitioner’s mother] was
not at home at the time of the first seizure.” Holmes, 2011 WL 2600612, at *9 (citing Pet’r’s Ex.
9 at 31 and Sp. Mstr. Tr. at 27–28). In his supplementary report, after citing the ambulance
record corresponding to the first seizure, Dr. Kinsbourne reports that petitioner’s axillary
temperature was recorded to be 100 degrees in the emergency department, and cites hospital
records which relate to the second seizure. See Pet’r’s Ex. 18 at 1. The Special Master noted
that the records for the second seizure cannot be the basis for a finding that petitioner had a fever
during his first seizure, and that petitioner’s expert failed to account for the petitioner’s
temperature of 97.6 degrees, recorded in the emergency room after the first seizure (which Dr.
Kinsbourne conceded was a normal temperature). Holmes, 2011 WL 2600612, at *9 (citing Sp.
Mstr. Tr. at 62). She found “no reliable evidence that [petitioner] was febrile at the time of his
initial seizure,” as skin feeling warm to the touch is relative, inaccurate, and not necessarily
indicative of a fever. Id. (citing Pet’r’s Ex. 19 at 1; Sp. Mstr. Tr. at 137–38; Pet’r’s Ex. 7 at 1, 3).
Moreover, Dr. Llobet’s report of the emergency room examination of petitioner after his first

11
seizure noted both that his temperature was 97.6 degrees and that his skin was “warm and dry,”
further indicating that “‘warm’ as applied to [petitioner] does not appear to refer to fever.” Id.
(citing Pet’r’s Ex. 9 at 31–32). 8

Regarding petitioner’s second seizure, the Special Master noted that although the
emergency room record indicated that petitioner had a fever, neither the emergency room
physician nor the treating physician diagnosed a febrile seizure, and the latter recorded that
petitioner’s second seizure was not preceded by a fever. Holmes, 2011 WL 2600612, at *9
(citing Pet’r’s Ex. 9 at 12, 17–19). Doctor Kinsbourne had misread a medical record, which
reported an oral temperature of 100°, as reporting an axillary temperature, and thus erroneously
concluded that this corresponded to an oral temperature of 101°. Id. at *9–10 (citing Pet’r’s Ex.
9 at 6; Pet’r’s Ex. 18 at 1; Sp. Mstr. Tr. at 63–64). The actual reading, and the rectal temperature
of 99.9° also taken during the second emergency room visit, were below the threshold used to
define febrile seizures in most studies. Id. at *10. 9 Based on the medical records, the Special
Master found that petitioner “had a slightly elevated temperature after his second seizure,” and
concluded “that the slight elevation in his temperature was not indicative of a febrile illness.” Id.
In sum, the Special Master “found no evidence that petitioner had a fever at the time of his initial
seizure, and, at best, only a slight fever after his second seizure.” Id. at *14.

Although Dr. Kinsbourne’s opinion could have been rejected merely because he misread
the medical records concerning petitioner’s temperature, Holmes, 2011 WL 2600612, at *16
(citing Perreira v. Sec’y of Dep’t of HHS, 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994)), the Special
Master explained in detail why she rejected that opinion in favor of Dr. Shinnar’s opinion that
petitioner’s symptoms did not meet the criteria for complex febrile seizures. Id. at *16–20.
There was no evidence of fever high enough to cause a febrile seizure, or of any febrile illness.
Id. at *17. Moreover, the Special Master was persuaded by Dr. Shinnar’s testimony that febrile
seizures occurred in childhood rather than adolescence, based on Dr. Shinnar’s own research and
another scientific study. Id. (citing Sp. Mstr. Tr. at 127–28, 132–33; Resp’t’s Ex. A21 at 495).
In particular, 99% of children in febrile seizure studies were under seven years of age, and the
oldest children with febrile seizures whom Dr. Shinnar had studied were nine and twelve years
old. Id. (citing Sp. Mstr. Tr. at 127–28, 132–33).

The Special Master also found Dr. Shinnar’s testimony in other areas to be “compelling”
and “undercutting petitioner’s cause-in-fact case.” Holmes, 2011 WL 2600612, at *18. She
discussed Dr. Shinnar’s explanations that the Micromedex evaluations would not establish
causation regarding illnesses that are not rare, and might have been based on the experiences of
very young children. Id. (citing Pet’r’s Ex. 16; Sp. Mstr. Tr. at 139–42, 198–201). She noted his
testimony that febrile seizures would need to exceed thirty minutes in length to cause epilepsy,

8
The Special Master also noted that petitioner “denied having fever or chills,” and that “the skin
temperature assessment was made on an August day in Chicago.” Holmes, 2011 WL 2600612,
at *9 (citing Pet’r’s Ex. 9 at 31; Sp. Mstr. Tr. at 82–83).
9
Moreover, “[t]he lowest temperature used in any study of febrile seizures and their sequelae is
100.4°, a higher temperature than any that [petitioner] experienced.” Holmes, 2011 WL
2600612, at *17 (citing Sp. Mstr. Tr. at 133–34).
12
and that this would be temporal lobe epilepsy --- and that petitioner exhibited neither. Id. (citing
Sp. Mstr. Tr. at 51–52, 190–91, 197–201). Though Dr. Shinnar acknowledged that sufficient
quantities of IL-1 beta could cause fever and seizures, larger quantities of IL-1 beta are needed to
produce fever in an adolescent, and the inflammatory reaction at the vaccination site in
petitioner’s case was insufficient to demonstrate such a presence of IL-1 beta. Id. at *19 (citing
Sp. Mstr. Tr. at 143–45, 147–48). Moreover, the cytokines released by an inflammation in the
arm would affect the whole brain rather than cause the type of focal seizures suffered by
petitioner. Id. (citing Sp. Mstr. Tr. at 151–52). As for the timing of the seizures, Dr. Shinnar
testified that the diagnosis of the onset of epilepsy was too soon after the October 2005 seizures
to have been caused by them, as the usual latency period is eight to eleven years. Id. at *20
(citing Resp’t’s Ex. A at 4).

Acknowledging that the opinions of petitioner’s treating physicians were entitled to
weight, the Special Master nonetheless did not find them persuasive. Holmes, 2011 WL
2600612, at *13. Three physicians examined petitioner on the day of his initial seizures and
allegedly attributed them to his vaccination. Id. One physician provided no rationale for that
opinion, id. (citing Pet’r’s Ex. 9 at 13); one noted that seizures were a listed side effect of the
vaccine without noting the reference source (a significant omission, since the reference might
have concerned a vaccine including pertussis which, unlike Td, is contraindicated for youths who
have histories of seizures), id. & n.28 (citing Pet’r’s Ex. 9 at 32; Resp’t’s Ex. D at 519; Sp. Mstr.
Tr. at 67–70); and one erroneously thought seizures were a reaction to horse serum, which was
not in fact present in the vaccine, id. (citing Pet’r’s Ex. 9 at 21; Sp. Mstr. Tr. at 75–76). In
contrast, the neurologist who diagnosed petitioner’s epilepsy considered his seizures to be of
“unclear etiology.” Id. (citing Pet’r’s Ex. 8 at 1). The Special Master noted that “even Dr.
Kinsbourne conceded that a neurologist would be better qualified to diagnose the cause of
seizures than physicians with less specialized training.” Id. (citing Sp. Mstr. Tr. at 72).

Characterizing the case as “more a rout than a ‘battle of the experts,’” the Special Master
concluded that petitioner failed to establish causation under the Federal Circuit’s decision in
Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005). See Holmes, 2011 WL 2600612, at *20.
She found that petitioner’s expert relied on facts that were not established and was not as
qualified as respondent’s expert in the areas of “diagnosing and treating febrile seizures and
epilepsy.” Id. Because of petitioner’s age and the lack of any febrile illness connected with the
August 18, 2005 seizures, the Special Master found the studies relied upon by Dr. Kinsbourne to
be irrelevant. Id. Determining there was no logical connection between the facts of petitioner’s
case and “the limited circumstances under which complex febrile seizures can result in
subsequent seizure disorders,” the Special Master denied the petition for compensation. Id.

D. Petitioner’s Motion for Review

Petitioner filed a motion for review, asking the Court to set aside the Special Master’s
decision on three grounds. Pet’r’s Mot. for Rev. (Pet’r’s Mot.) Under the Althen test,
petitioner’s burden was to show that the vaccination caused the 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.” Althen, 418 F.3d at 1278.

13
Petitioner argued that the Special Master erred as a matter of law in applying a too stringent
standard for the first prong under Althen; that the Special Master abused her discretion in failing
to give proper weight to the treating physicians’ opinions for the second prong of the Althen test;
and that the Special Master erred by considering matters outside of the record to determine the
credibility of petitioner’s expert, Dr. Kinsbourne. Pet’r’s Mot. at 14, 19, 22.

First, petitioner challenged the Special Master’s reliance on statistical data provided by
respondent’s expert, Dr. Shinnar, that epilepsy-causing febrile seizures were concentrated among
younger children, not adolescents. Pet’r’s Mot. at 12. Petitioner argued that “statistical evidence
cannot act as a preclusion to a causation theory.” Id. (citing Knudsen v. Sec’y of Dep’t of HHS,
35 F.3d 543, 550 (Fed. Cir. 1994)). He noted that the Special Master acknowledged that in
certain circumstances a Td vaccination can cause fever, leading to seizures and ultimately seizure
disorder. Id. (citing Holmes, 2011 WL 2600612, at *11). Doctor Shinnar conceded that this can
happen to young children, see Holmes, 2011 WL 2600612, at *12, and testified that 99% of these
seizures were suffered by children under age seven --- evidence that the Special Master found
persuasive. See id. at *17. Petitioner argued that the rarity of petitioner’s injury did not preclude
causation and that the first prong of the Althen test was satisfied by showing that the Td vaccine
can cause seizures. Pet’r’s Mot. at 13–14 (citing Capizzano v. Sec’y of HHS, 440 F.3d 1317,
1328 (Fed. Cir. 2006)). He further contended that Dr. Shinnar did not “rule . . . out entirely” the
possibility that a fourteen-year-old could suffer a seizure due to a Td vaccine, Pet’r’s Mot. at 14,
and that respondent’s expert testified “there is not much difference between a 10 and a 14-year
old,” id. at 12 (quoting Sp. Mstr. Tr. at 173). According to petitioner, this suffices under prong
one of Althen, and the Special Master impermissibly raised the standard for showing causation
“by relying on statistical factors.” Id. at 14.

Petitioner further argued that the Special Master erred in giving too little weight to
treating physicians’ opinions under the second prong of the Althen test. Pet’r’s Mot. at 15.
Citing excerpts from the medical record in which treating physicians attributed petitioner’s
August 18, 2005 seizures to the Td vaccine, petitioner argued that such evidence was “quite
probative” under Andreu v. v. Sec’y of HHS 569 F.3d 1367, 1375 (Fed. Cir. 2009). Id. at 16
(citing Pet’r’s Ex. 9 at 13, 21, 32). Though the Special Master highlighted a neurologist who
found the seizures to be of “unclear etiology,” petitioner argued that the neurologist did not rule
out vaccination as the cause and that his opinion should be outweighed by the three other
physicians’ records. Id. at 17–18.

Finally, petitioner contended that the Special Master erred in considering the challenge to
Dr. Kinsbourne’s credibility that was contained in respondent’s post-hearing brief. Pet’r’s Mot.
at 20–21. After the hearing, respondent informed the Special Master that Dr. Kinsbourne had
“come under increasing scrutiny in recent years for serving as an advocate for petitioners, rather
than proffering dispassionate expert opinion.” Id. at 21 (quoting Resp’t’s Post-Hr’g Br. at 9). In
her decision, the Special Master noted that Dr. Kinsbourne has been criticized in other cases for
extrapolating from scientific studies because of faulty premises. Holmes, 2011 WL 2600612, at
*20. Petitioner argued that the Special Master’s determination of credibility based on matters
outside the record was improper. Pet’r’s Mot. at 22.

14
 The Secretary filed a response to petitioner’s motion for review, arguing that the Special
Master properly denied compensation because petitioner failed to establish that his alleged injury
was caused by the Td vaccination. Resp’t’s Resp. to Pet’r’s Mot. for Rev. (Resp.) at 10.
Respondent noted the finding that petitioner was not febrile on August 18, 2005 was enough to
defeat petitioner’s causation theory. Id. at 11. According to respondent, the evidence that no
fourteen-year-old has been reported as experiencing a complex febrile seizure contradicted
petitioner’s medical theory of causation. Resp. at 11–12. The Secretary maintained that
statistics were properly considered to show the implausibility of petitioner’s theory. Id. at 13
(citing Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). Under the preponderant evidence
standard, respondent argued, petitioner failed to establish a prima facie case, and thus respondent
did not have the burden of “rul[ing] out entirely” petitioner’s medical theory. Id. at 12.

With respect to the opinions of petitioner’s treating physicians, respondent argued that
the Special Master properly weighed the conflicting impressions of three physicians and Dr.
Miner, the neurologist who diagnosed petitioner with epilepsy, and appropriately articulated the
reasons for preferring the latter’s opinion. Resp. at 14–15 (citing Cedillo v. Sec’y of HHS, 617
F.3d 1328, 1348 (Fed. Cir. 2010)). The Secretary noted that under the Vaccine Act, medical
diagnoses do not bind special masters or judges. Id. at 14 (citing 42 U.S.C. § 300aa-13(b)(1)(A),
(B)). Respondent also argued that treating physician testimony cannot establish causation
because petitioner failed to offer a medical theory to satisfy the first prong of the Althen test. Id.
at 14.

Regarding petitioner’s third objection, respondent argued that the Special Master did not
err in considering Dr. Kinsbourne’s Vaccine Program experience and compensation for legal
work. Resp. at 17. According to the Secretary, nothing barred the Special Master’s
consideration of Dr. Kinsbourne’s pattern of erroneous extrapolation in other cases. Id. at 17–18.
Respondent noted that petitioner had an opportunity to respond to the matters raised in the
former’s post-hearing brief. Id. at 18. And in any event, the Secretary maintained, the Special
Master had given more than sufficient reasons, other than Dr. Kinsbourne’s past experience, for
her assessment of the reliability of petitioner’s medical theory of causation. Id. at 19 (citing
Broekelschen v. Sec’y of HHS, 618 F. 3d 1339, 1350 (Fed. Cir. 2010)).

The Court held oral argument on petitioner’s motion. After careful consideration of the
medical records, testimony, and submitted literature in the record, the decision below, and the
arguments of counsel, this opinion issues.

II. DISCUSSION

A. Legal Standards

1. Court’s Standard of Review of a Special Master’s Decision

Under the Vaccine Act, the special master must award compensation if, “on the record as
a whole,” she finds “that the petitioner has demonstrated by a preponderance of the evidence” the
claims of the petition. 42 U.S.C. § 300aa-13(a)(1)(A). By this same standard, the special master
must find that nothing else is responsible for causing the injury. Id. § 300aa-13(a)(1)(B). “The

15
special master or court may not make such a finding based on the claims of a petitioner alone,
unsubstantiated by medical records or by medical opinion.” Id. § 300aa-13(a)(1). The special
master must consider all the “relevant medical and scientific evidence contained in the record,”
including any “diagnosis, conclusion, medical judgment, or autopsy . . . regarding the nature,
causation, and aggravation of petitioner’s illness, disability, injury, condition, or death” and “the
results of any diagnostic or evaluative test which are contained in the record and the summaries
and conclusions.” Id. § 300aa-13(b)(1). The Act further specifies that A[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master
or court.” Id. The special master is entrusted with evaluating the Aweight to be afforded to any”
of these sources of information. Id. A special master’s Aassessments of the credibility of the
witnesses” and of “the relative persuasiveness of the competing medical theories of the case” are
“virtually unchallengeable on appeal.” Lampe v. Sec’y of HHS, 219 F.3d 1357, 1362 (Fed. Cir.
2000). This deference rests on the special master’s Abroad discretion in determining credibility
because he saw the witnesses and heard the testimony,” Bradley v. Sec’y of Dep’t of HHS, 991
F.2d 1570, 1575 (Fed. Cir. 1993), and extends to assessments of expert testimony, see Moberly
v. Sec’y of HHS, 592 F.3d 1315, 1325–26 (Fed. Cir. 2010) (Moberly II).

Medical records Awarrant consideration as trustworthy evidence.” Cucuras v. Sec’y of the
Dep’t of HHS, 993 F.2d 1525, 1528 (Fed. Cir. 1993). These records are Agenerally
contemporaneous to the medical events,” and Aaccuracy has an extra premium” because a
patient’s proper treatment is Ahanging in the balance.” Id. Moreover, because medical records
are contemporaneous documentary evidence, conflicting oral testimony Adeserves little weight.”
Id. (citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947)).

In reviewing a special master’s decision, the Court may “set aside any findings of fact or
conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with law and issue its own findings of fact and conclusions of
law.” 42 U.S.C. § 300aa-12(e)(2)(B). Findings of fact are to be reviewed under the “arbitrary
and capricious” standard; legal questions are to be reviewed under the “not in accordance with
law” standard; and an abuse of discretion standard is used for discretionary rulings. See Munn v.
Sec’y of Dep’t of HHS, 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). With respect to the arbitrary
and capricious review, “no uniform definition of this standard has emerged,” but it is Aa highly
deferential standard of review” such that A[i]f the special master has considered the relevant
evidence of record, drawn plausible inferences and articulated a rational basis for the decision,
reversible error will be extremely difficult to demonstrate.” Hines ex rel. Sevier v. Sec’y of Dep’t
of HHS, 940 F.2d 1518, 1527–28 (Fed. Cir. 1991).

2. Standard of Causation in Vaccine Cases

A special master may award compensation through an “off-table” or “causation-in-fact”
case. Pafford v. Sec’y of HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006). Causation-in-fact --- the
basis for the legal entitlement to compensation when a petitioner’s injury is either not listed in
the Vaccine Injury Table or did not occur within the time period set forth in the Table --- must be
proven under two formulations adopted by the Federal Circuit. See Id. at 1355. The petitioner
must establish that the vaccine was both a “but-for” cause of the injury and a substantial factor in
causing the injury. See Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). Under a

16
three-part test more recently articulated by the Circuit, the petitioner must prove “(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.” Althen v. Sec’y of HHS, 418
F.3d 1274, 1278 (Fed. Cir. 2005). 10 The petitioner bears the burden of proving causation by
preponderant evidence. See 42 U.S.C. § 300aa-13(a)(1)(A).

A petitioner must show more than a proximate temporal relationship between the
vaccination and the injury to meet his burden of showing actual causation. Althen, 418 F.3d at
1278; see also Grant v. Sec’y of Dep’t of HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992).
Furthermore, “[t]here may well be a circumstance where it is found that a vaccine can cause the
injury at issue and where the injury was temporally proximate to the vaccination, but it is
illogical to conclude that the injury was actually caused by the vaccine.” Capizzano v. Sec’y of
HHS, 440 F.3d 1317, 1327 (Fed. Cir. 2006). A petitioner could meet the first and third prongs of
the Althen test without “satisfying the second prong when medical records and medical opinions
do not suggest that the vaccine caused the injury, or where the probability of coincidence or
another cause prevents the claimant from proving that the vaccine caused the injury by
preponderant evidence.” Id. The sequence only has to be A>logical’ and legally probable, not
medically or scientifically certain,” and thus can be established by Aepidemiological evidence
and [a] clinical picture,” even Awithout detailed medical and scientific exposition on the
biological mechanisms.” Knudsen v. Sec’y of Dep’t of HHS, 35 F.3d 543, 548–49 (Fed. Cir.
1994). Nonetheless, the Federal Circuit has stated that while Aepidemiological studies are
probative medical evidence relevant to causation,” Grant, 956 F.2d at 1149, they are not
necessarily dispositive. See id.

“The government . . . is permitted to offer evidence to demonstrate the inadequacy of the
petitioner’s evidence on a requisite element of the petitioner’s case[-]in-chief.” de Bazan v.
Sec’y of HHS, 539 F.3d 1347, 1353 (Fed. Cir. 2008). If the petitioner satisfies his burden, he is
entitled to compensation “unless the [government] shows, also by a preponderance of evidence,
that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278
(quoting Knudsen, 35 F.3d at 547) (alteration in original). But if the petitioner fails to prove
causation-in-fact by a preponderance of the evidence, “alternative causation theories . . . need not
be addressed.” Bradley, 991 F.2d at 1575.

3. Standard for Evaluating Expert Testimony

In determining the reliability or sufficiency of scientific evidence of causation in a case,
the special masters are guided by the factors identified by the Supreme Court in Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). See Terran v. Sec’y of HHS, 195 F.3d
1302, 1316 (Fed. Cir. 1999); Manville v. Sec’y of Dep’t of HHS, 63 Fed. Cl. 482, 489-91 (2004).
These non-exclusive factors relate to an “assessment of whether the reasoning or methodology
underlying [expert scientific] testimony is scientifically valid and of whether that reasoning or
10
Although the Federal Circuit has described the Althen test as an “alternative,” the very same
opinion makes plain that the Althen “prongs must cumulatively show” that the Shyface standard
is met. See Pafford, 451 F.3d at 1355.

17
methodology properly can be applied to the facts in issue.” Daubert, 509 U.S. at 592–93.
According to the Supreme Court, “a key question” to be asked of a proposed theory is “whether
it can be (and has been) tested,” as the scientific method entails “generating hypotheses and
testing them to see if they can be falsified.” Daubert, 509 U.S. at 593 (citations omitted).
“Another pertinent consideration is whether the theory . . . has been subjected to peer review and
publication.” Id. And “[w]idespread acceptance can be an important factor” in determining the
reliability of a theory, although it is not necessary. Id. at 594, 597. Concerning the applicability
of epidemiological studies, the Supreme Court has explained: “[N]othing in . . . Daubert . . .
requires a [trial] court to admit opinion evidence that is connected to existing data only by the
ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap
between the data and the opinion proffered.” General Elec. Co. v. Joiner, 522 U.S. 136, 146
(1997).

B. The Special Master Did Not Apply An Improper Standard in Evaluating Causation.

Petitioner’s first objection seems to rest on the odd notion that statistics should not be
considered in determining causation. As a general proposition this cannot be correct. Statistics,
after all, are in large part what epidemiology is all about, and causation can without question be
based on epidemiological evidence. See Knudsen, 35 F.3d at 549 (explaining that “causation can
be found in vaccine cases based on epidemiological evidence and the clinical picture”); Andreu
v. Sec’y of HHS, 569 F.3d 1367, 1379–81 (Fed. Cir. 2009); Moberly II, 592 F.3d at 1325.
Indeed, Vaccine Injury Table listings, giving rise to a presumption of causation, are often (if not
always) based on such statistics. See, e.g., National Vaccine Injury Compensation Program:
Revisions and Additions to the Vaccine Injury Table, 66 Fed. Reg. 36735, 36736 (proposed Jul.
13, 2001) (codified at 42 C.F.R. pt. 100) (explaining a table injury addition based on
“epidemiological data showing a strong statistical association between the rotavirus vaccine
administration and subsequent onset of intussusception”).

More specifically, petitioner contends that since the Special Master accepted that the Td
vaccination can cause febrile seizures and a seizure disorder for a certain segment of the
population, the first prong under Althen is satisfied and statistics may not be considered to
undermine this determination. See Pet’r’s Mot. at 12–14. This contention suffers from two basic
flaws. First, the argument about the misuse of statistics is based on a misunderstanding of the
Federal Circuit’s decision in Knudsen. See id. at 8, 12 (citing Knudsen, 35 F.3d at 550). That
decision did not hold that the use of any statistics would be improper to overcome a prima facie
causation case. Rather, it was the particular type of statistics that were being compared --- the
aggregate numbers of a particular injury caused by viral infections and by a vaccination, without
regard for the frequency with which each potential cause occurs. See Knudsen, 35 F.3d at 550.
In other words, a comparison of numerators tells you nothing about the increase in relative risk
due to two possible factors --- for that, you need the denominators, too.

But the statistics to which petitioner objects are relevant to determining whether a Td
vaccination could ever be considered the cause of an adolescent’s febrile seizures. The evidence
that febrile seizures were not only phenomena of infancy and childhood but moreover were
predominantly suffered by the very young has an obvious bearing on whether they could be the
result of a vaccination administered to someone outside of that age group. See Holmes, 2011

18
WL 2600612, at *17. Doctor Shinnar testified that 99% of the children with febrile seizures in
the reported literature are younger than seven years old, Sp. Mstr. Tr. at 127–28, and even in the
Annegers study relied upon by Dr. Kinsbourne, 88% of the children with febrile seizures were
three years old and younger, id. at 128; see Pet’r’s Ex. 15 at 493, 495. Respondent’s expert
explained that febrile seizures are universally understood to be childhood illnesses, and the
scientific studies define a child usually below age ten although occasionally as old as eleven.
See Resp’t’s Ex. A at 4; Sp. Mstr. Tr. at 126–33. In all of his research he only knew of one
person as old as twelve who might have suffered a febrile seizure, Holmes, 2011 WL 2600612, at
*17; Sp. Mstr. Tr. at 132–33, and neither expert pointed to any study indicating an adolescent as
old as fourteen had suffered a febrile seizure. It is no error to consider such evidence when
deciding whether a febrile seizure could explain petitioner’s injuries. Based on the evidence,
febrile seizures for a fourteen-year-old are not “rare,” as petitioner maintains, see Pet’r’s Mot. at
13, but (at least heretofore) nonexistent.

This brings us to the second flaw in petitioner’s contention. Petitioner assumes that
prong one of Althen --- “a medical theory causally connecting the vaccination and the injury,”
Althen, 418 F.3d at 1278 --- is established when medical literature shows causation for a
demographic that excludes him. But “[a] petitioner must provide a reputable medical or
scientific explanation that pertains specifically to the petitioner’s case.” Moberly II, 592 F.3d at
1322. The Federal Circuit has explained, in a slightly-different context: “As a general matter,
epidemiological studies are designed to reveal statistical trends only for a carefully constructed
test group. Such studies provide no evidence pertinent to persons not within the parameters of
the test group.” Id. at 1324. Thus, if a study supports causation when a particular injury
manifests within seven days of a vaccination, this does not require the Secretary to explain the
biological reasons why an injury occurring several months later was not similarly caused. See
Moberly v. Sec’y of HHS, 85 Fed. Cl. 571, 598 (2009) (Moberly I), aff’d, 592 F.3d at 1324. In
our case, medical literature supporting causation of injuries in a different age group does not
impose a burden on respondent to explain whether physiological differences between ten-year-
olds and fourteen-year-olds could account for a difference in reactions to a vaccine. Cf. Pet’r’s
Mot. at 12 (arguing to the contrary). Absent epidemiological evidence to support causation, it
remained the job of petitioner, not respondent, to supply a reputable medical or scientific
explanation of causation.

As the Special Master amply and well explained, see Holmes, 2011 WL 2600612, at *11–
12, whether the Td vaccination can generally cause fever, febrile seizures, and seizure disorder
are not the relevant questions to establish the first prong of Althen in petitioner’s case.
Considering the testimony and literature supplied by both experts, she concluded that the medical
theory by which the vaccination can cause the injuries must take into account such factors as the
age of the patient, the severity of the fever and the duration of the seizures. Id. The statistics (or,
more accurately, the lack of any) showing febrile seizures suffered by members of petitioner’s
age group were but one consideration in determining that petitioner had failed to prove
causation-in-fact.

The Special Master summarized petitioner’s causal chain as the vaccination causing a
febrile response, the fever causing complex febrile seizures, and the complex febrile seizures
causing petitioner to have a seizure disorder which was later diagnosed as epilepsy. Holmes,

19
2011 WL 2600612, at *13. Petitioner’s expert conceded his opinion was based on the August
18, 2005 seizures having been febrile. Sp. Mstr. Tr. at 57–59. But the Special Master found
there was no reliable evidence of a fever connected with the first seizure. Holmes, 2011 WL
2600612, at *9. Doctor Kinsbourne mistakenly believed that petitioner’s mother “stated that he
felt hot,” Pet’r’s Ex. 14 at 1, when she was not even home at the time of his first seizure.
Holmes, 2011 WL 2600612, at *9 (citing Pet’r’s Ex. 9 at 31; Sp. Mstr. Tr. at 27–28). The
recorded temperature in the treating physician’s narrative and the ER records showed petitioner
had a temperature of 97.6° after his first seizure, see Pet. Ex. 7 at 1, 3; Pet. Ex. 9 at 31–32, and
Doctor Kinsbourne conceded that a 97.6° temperature was normal, Sp. Mstr. Tr. at 62. And
while petitioner’s temperature was recorded as being higher in connection with his second
seizure, the Special Master reasonably found that seizure not to be febrile, as petitioner’s
temperature was recorded at its peak to be 100° when taken orally, and 99.9° rectally --- both
short of the 101° threshold for a febrile seizure. Holmes, 2011 WL 2600612, at *9–10, *17
(citing, inter alia, Pet’r’s Ex. 9 at 6; Resp’t’s Exs. A1 at 1122, A6 at 1743). 11 Concerning this
seizure, Dr. Kinsbourne misread the medical record showing an oral temperature of 100° as an
axillary temperature and had erroneously translated it to an oral temperature of 101°, which he
had testified would meet the minimum threshold for most studies on febrile seizures. Sp. Mstr.
Tr. at 63–64; see Pet’r’s Ex. 9 at 6. On top of all this, the Special Master reasonably determined
that there was no evidence to support the presence of a febrile illness suffered by petitioner in
proximity to the August 18, 2005 seizures. Holmes, 2011 WL 2600612, at *17. 12

Thus, petitioner’s medical theory of causation suffered from problems other than
petitioner being the wrong age to experience febrile seizures. 13 The Special Master also found
that the fever necessary for any reliable version of this theory was not demonstrated by the
record evidence --- a finding which petitioner does not seem to challenge. She also reasonably
determined that respondent’s expert provided “compelling testimony undercutting” much of the
rest of petitioner’s theory of causation, id. at *18, including that the August 18, 2005 seizures
were too short in duration to have caused petitioner’s epilepsy, id.; that IL-1 beta was unlikely to
cause focal seizures and that sufficient amounts of it were not evidenced, id. at *19; and that the
onset of petitioner’s epilepsy was too soon after the August 18, 2005 seizures to be their result,
id. at *20. The Special Master did not subject petitioner’s case to an improperly stringent
standard of causation; rather, she appropriately applied the correct standards to find that

11
The Special Master also noted that “[t]he lowest temperature used in any study of febrile
seizures and their sequelae is 100.4°, a higher temperature than any that [petitioner]
experienced.” Holmes, 2011 WL 2600612, at *17 (citing Sp. Mstr. Tr. at 133–34).
12
The Court notes that the EMS report concerning the second seizure indicated that petitioner’s
temperature was normal at the time. Pet’r’s Ex. 7 at 4.
13
Without elaboration or explanation, petitioner suggests that the Micromedex evaluations
satisfy prong one of Althen. See Pet’r’s Mot. at 14. But the Special Master rationally explained
why such reports are unpersuasive, see Holmes, 2011 WL 2600612, at *13 n.31, discussing Dr.
Shinnar’s testimony and other evidence that the Td vaccine is recommended for adolescents with
seizure disorders. Id. at *18 (citing Sp. Mstr. Tr. at 139–42; Resp’t’s Ex. D at 519).
20
petitioner failed to demonstrate a reliable medical theory that was logically connected to his
circumstances. Petitioner’s first objection is accordingly rejected.

C. The Special Master did Not Abuse her Discretion in her Evaluation of the Treating
Physicians’ Opinions

Disagreeing with the Special Master’s determinations of the probative value of some of
the notations in the medical records made by treating physicians, petitioner maintains that the
Special Master abused her discretion. See Pet’r’s Mot. at 15–19. Petitioner argues that the
second prong of Althen was satisfied by these medical opinions. Id. at 18. But “Federal Circuit
precedent makes it evident that the first prong of Althen must be proven before the opinions of
treating physicians may clinch causation under the other prongs.” Langland v. Sec’y of HHS,
109 Fed. Cl. 421, 438 (2013) (citing Andreu, 569 F.3d at 1375). While there might be
circumstances in which a treating physician’s opinion itself provides an adequate basis to find
Althen prong one satisfied, for instance by containing a reliable theory explaining how the
vaccine caused the injury in question, see id. at 438–39, the opinions relied upon by petitioner
are not that sort. Indeed, petitioner insists that he “satisfies the first prong of the Althen test
without reliance upon the treating physicians’ reports,” Pet’r’s Mot. at 18.

Although the failure to establish a medical theory satisfying the first prong of Althen
might well make the objection regarding the second prong academic, the Court nevertheless has
reviewed this objection and found it wanting. While the statements of treating physicians can be
“quite probative” of the prong two “logical sequence of cause and effect,” see Andreu, 569 F.3d
at 1375 (internal citations and quotations omitted), the Vaccine Act makes plain that such
statements must be considered but “shall not be binding on the special master or the court,” and
mandates that the “entire record” must be considered in evaluating their weight, 42 U.S.C.
§ 300aa-13(b)(1). Thus, even diagnoses of causation may be outweighed by other evidence. See
Moberly I, 85 Fed. Cl. at 604 (explaining that such a diagnosis “would, at the least, require the
Special Master to explain how other evidence outweighed these medical records”). The Court
agrees with respondent that “‘[t]he Special Master clearly articulated why [she] declined to
afford significant weight to the notations made by [some of petitioner’s] treating physicians,’ and
accordingly committed no error.” Resp. at 15 (quoting Cedillo, 617 F.3d at 1348).

Petitioner focuses on three records, two of which were from the emergency room,
generated on the date of his initial seizures --- containing the opinions of Drs. Schultz, Llobet
and Yang. Pet’r’s Mot. at 16 (citing Pet’r’s Ex. 9 at 13, 21, 32). The Special Master admitted
that these opinions were “entitled to weight,” Holmes, 2011 WL 2600612, at *13 (citing Andreu,
569 F. 3d at 1375), and she referenced them, cited to them, and gave reasonable explanations for
why she did not consider them probative. Doctor Yang wrote concerning petitioner that “[g]iven
his recent history of a tetanus vaccine, he could well have had a reaction towards the vaccine
components, probably horse serum.” Pet’r’s Ex. 9 at 21. This opinion was found erroneous, as
petitioner’s expert acknowledged that the Td vaccine does not contain horse serum. Holmes,
2011 WL 2600612, at *13 (citing Sp. Mstr. Tr. at 75–76). Doctor Llobet recorded the
impression “[s]eizure, status post tetanus shot,” and wrote that she “had looked up the tetanus
adverse reactions and one of them it listed is seizures.” Pet’r’s Ex. 9 at 32. The Special Master
found it significant that Dr. Llobet did not identify the reference she consulted, as the tetanus

21
vaccination is often combined with one for pertussis, and evidence in the record indicated that
adolescents with a history of seizures may be administered the former but not the latter. Holmes,
2011 WL 2600612, at *13 n.28 (citing Resp’t’s Ex. D at 519). And Dr. Schultz wrote the
impression “[s]eizure by history, most likely secondary to tetanus toxoid immunization,” Pet’r’s
Ex. 9 at 13, which the Special Master accurately noted as “providing no rationale,” Holmes,
2011 WL 2600612, at *13.

Of the three medical reports, then, one was demonstrably wrong and the other two were
found to lack a sufficient explanation. The substantive quality (and quantity) of the diagnoses
was very far from that in Andreu, for instance, in which the treating physicians took the witness
stand and explained their opinions. See Andreu, 569 F.3d at 1376. Moreover, the Special Master
properly considered the entire record in determining the amount of weight these records should
receive. She determined that the opinions rendered on the day of petitioner’s initial seizures
were “countered” by the opinion of the neurologist who subsequently treated petitioner. Holmes,
2011 WL 2600612, at *13. Petitioner’s expert “conceded that a neurologist would be better
qualified to diagnose the cause of seizures than physicians with less specialized training.” Id.
(citing Sp. Mstr. Tr. at 72). And the neurologist in question, Dr. Miner, while noting the
temporal proximity of the Td vaccination and the initial seizures, nevertheless determined that
the seizures were of “unclear etiology.” Id. (quoting Pet’r’s Ex. 8 at 1). The Special Master did
not abuse her discretion in evaluating the medical records, but instead provided a careful,
thorough and reasoned explanation for the weight she gave them, supported by reference to other
parts of the record. No error was committed in this evaluation. 14

D. The Special Master did Not Act Improperly in Determining the Credibility of Experts

In petitioner’s third objection, he contends that the Special Master acted improperly by
basing her determination of expert credibility on matters that were outside the record. Pet’r’s
Mot. at 19–22. Petitioner complains that the Special Master cited two decisions in which Dr.
Kinsbourne had been criticized, and argues that respondent unfairly included a similar discussion
(concerning other cases) in the government’s post-hearing brief. Id. at 20–21 (citing Resp’t’s
Post-Hr’g Br. at 9–11; Holmes, 2011 WL 2600612, at *20). 15 The Court finds this objection
lacks merit.

“Under the Vaccine Act, Special Masters are accorded great deference in determining the
credibility and reliability of expert witnesses,” and a court will not disturb such determinations

14
Petitioner also references three excerpts from his medical records, created after the initial
seizures, which he contends establish that he has suffered from encephalopathy since receiving
the vaccination. Pet’r’s Mot. at 15 (citing Pet’r’s Exs. 8 at 26, 10 at 7, and 11 at 10). None of
these records discuss the vaccination as the cause of his injuries.
15
The Special Master’s mere mention, in a footnote, of the percentage of petitioner’s expert’s
income that derives from legal matters, is wrongly characterized by petitioner as a “criticism.”
See Pet’r’s Mot. at 20; Holmes, 2011 WL 2600612, at *2 n.9. In any event, this statement was
based on evidence in the record, see Sp. Mstr. Tr. at 57, and thus has no relevance to the third
objection.
22
when “the Special Master clearly articulated [her] reasons for discrediting [an] expert’s opinion.”
Cedillo, 617 F.3d at 1347. The Federal Circuit has explained:

it is not . . . the role of this court to reweigh the factual evidence, or to assess
whether the special master correctly evaluated the evidence. And of course we do
not examine the probative value of the evidence or the credibility of the witnesses.
These are all matters within the purview of the fact finder.

Munn v. Sec’y of Dep’t of HHS, 970 F.2d 863, 871 (Fed. Cir. 1992).

The Court finds that the Special Master did not err as a matter of law in her credibility
determination, nor did she improperly base her decision on matters outside the record. Rather,
she painstakingly and in great detail explained the reasons why she found respondent’s expert to
be more credible.

First, there were the problems with petitioner’s expert’s testimony. Doctor Kinsbourne’s
causation theory rested on petitioner having had a fever at the time of both seizures on August
18, 2005, such that the seizures met the definition of complex febrile seizures, but this opinion
was based on errors and unsupported by the factual evidence in the record. See Holmes, 2011
WL 2600612, at *8–9, *16. For example, as discussed above, the Special Master expressed
concern that Dr. Kinsbourne based his opinion of fever during the first seizure on the EMS
description of skin temperature and on a “mistaken impression” that petitioner’s mother was
present, id. at *8 (citing Pet’r’s Ex. 7 at 1, 3; Pet’r’s Ex. 14 at 1), yet Dr. Kinsbourne overlooked
or discounted the fact that the emergency room recorded James’s temperature as 97.6°, which he
later conceded was a normal temperature, id. at *9 (citing Pet’r’s Ex. 14 at 1; Pet’r’s Ex 9 at 28;
Sp. Mstr. Tr. at 62). Additionally, because Dr. Kinsbourne based his opinion mainly on the
record pertaining to petitioner’s second seizure, id. at *9 (citing Pet’r’s’ Ex. 18 at 1), the Special
Master considered his error particularly significant when he mistakenly read the report as
showing petitioner had an axillary temperature of 100°, id. at *9–10. The Special Master
explains that Dr. Kinsbourne “misread the medical records in forming his conclusion that
[petitioner] was febrile at the time of the first seizure and had an ‘elevated’ temperature at the
time of the second,” and “[t]his mistake alone justifies rejecting Dr. Kinsbourne’s opinion.” Id.
at *16.

The Special Master primarily found fault with the chain of causation offered by Dr.
Kinsbourne, explaining that even if she were to accept Dr. Kinsbourne’s proposed theory,
“petitioner’s case fails, because the factual predicate for Dr. Kinsbourne’s opinions is lacking.”
Holmes, 2011 WL 2600612, at *12. The Special Master evaluated each element of Dr.
Kinsbourne’s causation theory, and compared the evidence Dr. Kinsbourne relied upon to the
factual evidence in the record. Id. She repeated her concern that Dr. Kinsbourne testified in the
hearing that without the presence of fever he would not present the same opinion about
causation. Id. at *14 (citing Sp. Mstr. Tr. at 57–59). Because the facts did not support that
petitioner had a fever at the time of the first seizure and only supported a possible slight fever at
the time of the second, the Special Master stated that Dr. Kinsbourne’s testimony of petitioner’s
fever causing the initial seizures “is an exceedingly weak link in Dr. Kinsbourne’s causal chain.”
Id. The Special Master also thought Dr. Kinsbourne relied on circular reasoning when he opined

23
that the initial seizures were themselves evidence of a lowered seizure threshold but did not offer
any other evidence that petitioner had a lower seizure threshold. Id.

Second, the Special Master fully explained why she found Dr. Shinnar’s opinions more
credible than Dr. Kinsbourne’s. She determined that Dr. Shinnar’s opinions were “careful,
nuanced, and supported by the medical literature,” and “reflected his considerable experience in
studying and treating seizure disorders.” Holmes, 2011 WL 2600612, at *16. She found Dr.
Shinnar’s opinion regarding the effect of febrile seizures to be more reliable because of his
“considerable expertise in the diagnosis and treatment of such disorders, his research credentials
in the field, and the medical literature filed by both parties.” Id. at *12. This is a reasonable
basis on which to make a credibility determination. See Terran, 195 F.3d at 1316. The Special
Master also found it important that Dr. Shinnar differentiated febrile seizures from epilepsy,
which Dr. Kinsbourne did not do, and that his refutation of Dr. Kinsbourne’s diagnosis of
complex febrile seizures conformed to the facts in the record. Holmes, 2011 WL 2600612, at
*16. The Special Master noted that Dr. Shinnar offered other testimony which undermined
petitioner’s theory of causation, such as presenting credible medical literature to disprove the
possibility of Td vaccinations causing seizures in fourteen-year-olds, and to show that short
febrile seizures do not cause epilepsy. Id. at *18–19.

After carefully considering and discussing in great detail the testimony of both experts,
see id. at *13–20, the Special Master concluded that “[m]ost of the ‘facts’ upon which
[petitioner’s expert] relied were not established;” that “he either misread or misinterpreted the
medical records”; and that he “lacked the research qualifications and clinical expertise in
diagnosing and treating febrile seizures and epilepsy to prevail over an opposing expert with
truly impressive qualifications in these areas.” Id. at *20. She then mentioned in passing that
petitioner’s expert “has been criticized in the past for extrapolating from studies of the DPT
vaccine to the DTaP vaccine.” Holmes, 2011 WL 2600612, at *20 (citing Tembenis v. Sec’y of
Dep’t of HHS, No. 03-2820V, 2010 WL 5164324, at *8 n.9 (Fed. Cl. Spec. Mstr. Nov. 29, 2010)
(citing Simon v. v. Sec’y of Dep’t of HHS, No. 05-941V, 2007 WL 1772062, at *7 (Fed. Cl. Spec.
Mstr. June 1, 2007))). This was followed by a similar description of the shortcomings of
petitioner’s expert’s testimony in this case, as he was found to have “extrapolated from studies of
infants and young children, whom he acknowledged have brains that are very different from
older children and adolescents ([Sp. Mstr.] Tr. at 106), to apply their findings and conclusions to
a seizure disorder in an adolescent.” Id. It is clear that the basis for this description was the
Special Master’s assessment of the expert opinions presented in this case. 16 She was not
deducing that petitioner’s expert must have erroneously extrapolated here because he did it
elsewhere. Even assuming that the consideration of an expert witness’s reputation and
credibility as determined in other cases would be improper in determining the credibility of his
testimony --- a proposition which petitioner fails to support --- no such thing was done by the

16
Judicial officers may, of course, properly consider whether an expert’s opinion suffered from
“too great an analytical gap between the data and the opinion proffered.” Gen. Elec. Co., 522
U.S. at 146.

24
Special Master below. Accordingly, petitioner’s third objection is rejected, as the Special Master
did not commit legal error in making her credibility determinations. 17

III. CONCLUSION

Petitioner’s motion for review is DENIED and the decision of the Special Master is
SUSTAINED. The Clerk of Court is directed to enter judgment for respondent.

IT IS SO ORDERED.

s/ Victor J. Wolski
VICTOR J. WOLSKI
Judge

17
Moreover, it does not appear that the criticisms of petitioner’s expert that were recited in
respondent’s post-hearing brief had any bearing on the Special Master’s credibility assessment.
In any event, petitioner had the opportunity to address them in a reply paper and chose not to do
so. See Pet’r’s Post-Hr’g Reply Mem. at 1–2.
25