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) †

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*

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

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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

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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