Doe v. Secretary of Health and Human Services

United States Court of Appeals for the Federal Circuit
2009-5096

JOHN DOE, 11, and JANE DOE, 11,
As Representatives of the Estate of
CHILD DOE, 11, Deceased,

Petitioners-Appellants,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent-Appellee.

Richard Gage, Richard Gage, P.C., of Cheyenne, Wyoming, argued for
petitioners-appellants.

Glenn A. MacLeod, Senior Trial Attorney, Torts Branch, Civil Division, United
States Department of Justice, of Washington, DC, argued for respondent-appellee.
With him on the brief were Tony West, Assistant Attorney General, Timothy P. Garren,
Director, Mark W. Rogers, Deputy Director, and Catharine E. Reeves, Assistant
Director.

Appealed from: United States Court of Federal Claims

Judge Mary Ellen Coster Williams
United States Court of Appeals for the Federal Circuit
2009-5096

JOHN DOE, 11, and JANE DOE, 11,
As Representative of the Estate of
CHILD DOE, 11, Deceased,

Petitioners-Appellants,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent-Appellee.

Petition for review of the United States Court of Federal Claims in 99-VV-212, Judge
Mary Ellen Coster Williams.

__________________________

DECIDED: April 13, 2010
__________________________

Before BRYSON, GAJARSA, and PROST, Circuit Judges.

PROST, Circuit Judge.

This is a Vaccine Act 1 case. We must decide whether the claimants, John and

Jane Doe (collectively “Doe”), met their burden of proving that their daughter Monica’s

death was caused by a hepatitis B vaccination. See 42 U.S.C. § 300aa-11. It is an off-

Table case because Monica’s injury is not listed in the Vaccine Act Injury Table. See 42

U.S.C. § 300aa-14; 42 C.F.R. § 100.3(a). Accordingly, the burden was on Doe to prove

1
The official title is the National Childhood Vaccine Injury Act of 1986 (the
“Vaccine Act”), Pub. L. No. 99-660, tit. III, § 311, 100 Sat. 3756 (codified as amended in
scattered sections of 42 U.S.C.).
that Monica’s death was actually caused by the vaccine. 42 U.S.C. § 300aa-11(c); see

Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146, 1149 (Fed. Cir. 2007).

Under the test for causation set out in Althen v. Secretary of Health and Human

Services, 418 F.3d 1274 (Fed. Cir. 2005), a claimant must prove three things: (1) a

medical theory causally connecting the vaccination to the injury, (2) a logical sequence

of cause and effect showing the vaccination was the reason for the injury, and (3) a

proximate temporal relationship between the vaccination and the injury. Id. at 1278. In

this case, the special master denied compensation, concluding that Doe failed to prove

prongs two and three of the Althen test by a preponderance of evidence. In a careful,

well-reasoned opinion, the U.S. Court of Federal Claims upheld the special master’s

decision. Doe ex. rel Estate of Child Doe v. Sec’y of Health & Human Servs., 87 Fed.

Cl. 1 (2009) (“Doe IV”). We now affirm.

Our review primarily focuses on the special master’s factual findings, which were

subsequently adopted by the Court of Federal Claims. Under the Vaccine Act, the

question is whether these findings were arbitrary, capricious, an abuse of discretion, or

otherwise not in accordance with the law. 42 U.S.C. § 300aa-12(e)(2)(B). In addition,

we must decide whether the special master committed legal error by considering

evidence of a possible alternative cause, Sudden Infant Death Syndrome (“SIDS”), in

deciding whether Doe established a prima facie case.

We reach the same conclusion as the Court of Federal Claims. The special

master’s factual findings regarding the significance of the decedent’s length, weight of

her brain and other organs, and pre-death behavior were not arbitrary or capricious,

particularly in light of the credibility findings made as to the parties’ respective experts.

2009-5096 2
Further, under this court’s decisions in de Bazan v. Secretary of Health and Human

Services, 539 F.3d 1347 (Fed. Cir. 2008), and Pafford v. Secretary of Health and

Human Services, 451 F.3d 1352, 1359 (Fed. Cir. 2006), the special master did not

commit legal error in considering evidence of SIDS, an allegedly alternative cause.

Nothing in the Vaccine Act prohibits the government from presenting evidence that the

petitioner’s injury was due to “factors unrelated” to the vaccine (here, SIDS). Under 42

U.S.C. § 300aa-13(a) and de Bazan, the special master could consider such evidence

in deciding whether Doe established a prima facie case; the Vaccine Act only prohibits

the government from rebutting an established prima facie case with an idiopathic

condition like SIDS. 42 U.S.C. § 300aa-13(a)(2)(A).

BACKGROUND

Monica Doe was born in October 1994. On the day she was born, she received

her first hepatitis B vaccination. Monica was discharged from the hospital the next day.

At approximately 2 p.m. on December 21, 1994, Monica received her second

vaccination for hepatitis B. At the time, Monica was seven and a half weeks old and

weighed eleven pounds. The vaccine was administered to Monica’s thigh. After the

doctor’s appointment, the family went shopping. During the shopping trip, Monica was

carried in an infant car seat by her father. Her father testified that Monica slept the

entire time, without evidencing a fever, abnormal jerking, or crying. Her mother testified

that Monica was awake during the shopping trip and unusually quiet, since Monica

“usually” cried. To the extent their accounts conflicted, the special master credited the

father’s testimony that Monica was asleep, because the father was the one carrying

Monica.

2009-5096 3
 Around 5 p.m., the family returned home. Monica’s mother and two brothers lay

down for a nap in the bedroom, while Monica and her father remained in the living room.

Monica’s father lay down on the couch to watch the news, positioning Monica next to

him, propped face up on a pillow. Monica’s father testified that he fell asleep on the

couch between 5:30 and 6 p.m. When he awoke approximately thirty minutes later,

Monica was “blue in the face.” Awakened by calls from her husband, Monica’s mother

observed Monica lying face up on the pillow, with a “bluish” complexion. Monica was

not breathing when her parents called 911 at 6:49 p.m. The ambulance arrived about

five minutes later, by which time Monica’s father had begun CPR.

The emergency medical technician (“EMT”) who responded to the 911 call

observed Monica face up on the couch, receiving CPR from a fire department

emergency responder. The EMT found Monica had no heartbeat and was not

breathing, though her skin was warm and dry. He observed that Monica’s extremities

were “mottled and chest and abdomen were white,” while her abdomen was

“distended.” At the emergency room, a physician diagnosed Monica as having suffered

cardiopulmonary arrest, cause unknown. Monica was pronounced dead at 8 p.m.,

approximately six hours after she received her hepatitis B vaccination.

A forensic pathologist named Dr. Robert Anthony performed an autopsy the

following day. His report notes a “moderate amount of fixed purple livor mortis over the

posterior aspects of the body surfaces.” Monica’s stomach and bladder were empty.

Her lungs, however, exhibited “moderate pulmonary congestion and edema,” and her

heart had “rare epicardial petechiae.” Significantly, Dr. Anthony opined that Monica’s

brain was “grossly unremarkable,” with “no evidence of edema or herniation” and “clear,

2009-5096 4
glistening and intact” meninges. The report lists a brain weight of 570 grams and SIDS

as the cause of death. At the time he performed the autopsy, Dr. Anthony did not know

the circumstances surrounding Monica’s death.

Monica’s parents (collectively, “Doe”) subsequently filed a claim under the

Vaccine Act on behalf of Monica’s estate. The claim alleges that Monica died as a

result of receiving a hepatitis B vaccination on December 21, 1994. The special master

assigned to the case held an evidentiary hearing. Among the evidence presented at the

hearing was expert testimony by Dr. John Shane and Dr. Alan Levin for Doe, and expert

testimony by Dr. Enid Gilbert-Barness and Dr. Christine McCusker for the government.

Dr. Shane, accepted as an expert in pathology generally, though not pediatric

pathology, opined that Monica died from acute encephalopathy caused by the hepatitis

B vaccine. In support of this theory, Dr. Shane cited Monica’s brain weight, which he

testified was “abnormally” high for a child of that age and thus evidence of cerebral

edema. Doe’s other expert, Dr. Levin, similarly opined that Monica’s death was caused

by the hepatitis B vaccine. Accepted as an expert in immunology, Dr. Levin testified

that the vaccine led to excessive cytokine release, followed by cerebral edema. The

edema, in turn, resulted in decreased blood flow, causing Monica’s death.

Both of the government’s experts rejected Doe’s theory of causation. Dr. Gilbert-

Barness, qualified as an expert in pediatric neuropathology, opined that the hepatitis B

vaccine was not the cause of Monica’s death. She rejected Dr. Shane’s conclusion that

Monica’s brain weight was abnormally high, finding no evidence of significant brain

edema or other abnormalities in the same slides reviewed by Dr. Shane. Nor did Dr.

Gilbert-Barness agree with Dr. Shane’s diagnosis of acute encephalopathy, because

2009-5096 5
“one would expect to see considerable brain edema” and “very likely” herniation of the

brainstem as the cause of death, neither of which were found here.

The government’s other expert, Dr. McCusker, similarly disagreed with Doe’s

experts. Dr. McCusker was accepted as an expert in pediatric immunology. Dr.

McCusker opined that the timing of Monica’s death undermined Dr. Levin’s cytokine

storm theory, because edema resulting from such inflammation would have required

days, not hours, to develop. Dr. McCusker elaborated that Monica exhibited no

symptoms characteristic of an escalating cytokine response or edema, such as fever,

seizures, vomiting, high-pitched screaming, marked somnolence, or coma.

The special master concluded that Doe did not establish a prima facie case that

the hepatitis B vaccination caused Monica’s death. Instead, the special master found

that Monica’s death was caused by SIDS, a factor unrelated to the vaccination.

The Court of Federal Claims reversed. Doe ex rel. Estate of Doe v. Sec’y of

Dep’t of Health & Human Servs., 83 Fed. Cl. 157, 158 (2008) (“Doe II”). It held that the

special master improperly shifted the burden of proof to Doe by requiring that Doe

affirmatively disprove SIDS caused Monica’s death as part of their prima facie case. Id.

The court remanded the case to the special master with instructions to reweigh the

evidence in light of the burden of proof set forth in Althen and Walther. Doe II, 83 Fed.

Cl. at 176.

On remand, the special master again concluded that Doe was not entitled to

compensation because Doe had not established a prima facie case of causation.

Specifically, the special master found that Doe had failed to prove the second or third

prong of Althen by a preponderance of evidence. The special master still considered

2009-5096 6
evidence relating to SIDS, but only in evaluating whether Doe’s proposed sequence of

cause and effect was plausible. Doe again petitioned for review.

The Court of Federal Claims denied Doe’s petition. Doe IV, 87 Fed. Cl. at 15. In

upholding the special master’s decision, the court found the special master’s factual

findings were not arbitrary and capricious, including those with respect to Monica’s brain

weight. Id. at 12. The court also held that the special master did not err in considering

evidence of SIDS in deciding whether Doe established a prima facie case. Id. at 13-14.

Doe now appeals. We have jurisdiction pursuant to 42 U.S.C. § 300aa-12(f).

DISCUSSION

We review de novo decisions by the Court of Federal Claims arising under the

Vaccine Act. Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d

1315, 1321 (Fed. Cir. 2010). In doing so, we apply the same standard the Court of

Federal Claims applied to the special master’s decision: Factual findings are reviewed

under the arbitrary and capricious standard; legal rulings are reviewed for whether they

are in accord with the law. Id.; see also 42 U.S.C. § 300aa-12(e)(2)(B).

I. Special Master’s Fact Finding

We begin with certain factual findings made by the special master. These

findings matter because they were the basis on which the special master rejected Dr.

Shane’s theory of cause and effect, which posited that Monica died as the result of

cerebral edema caused by acute encephalopathy. The primary evidence Dr. Shane

cited in support of his theory was Monica’s brain weight of 570 grams, which he deemed

“abnormally” high for a child of her age and so heavy it could only be explained by

severe edema and encephalopathy. This opinion was based in part on Dr. Shane

2009-5096 7
finding Monica’s height to be in the fiftieth percentile for her age group and attributing

the above-average weights of her other organs to edema. On appeal, Doe argues that

the special master’s findings of fact as to Monica’s height, weight of her brain and other

organs, and pre-death behavior were arbitrary and capricious. For the following

reasons, we do not agree.

The special master concluded that Monica’s brain was not abnormally heavy or

significantly “edematous,” as Dr. Shane claimed. In reaching this conclusion, the

special master relied on expert testimony and on several different tables of average

brain weights for infants. For a two-month old, the medical literature listed weights of

489 grams, 490 grams, and 516 grams. Dr. Shane testified that the expected range for

brain weight was “440 to 540” grams, given the standard deviation for the table he used.

Accounting for the table’s listed error of 14 grams, Dr. Shane opined that 555 grams

would be the “top limit of normal.” Noting that Monica’s brain weight was “not much

beyond” the range of normal brain weights, the special master declined to credit Dr.

Shane’s opinion that brain weight alone proved Monica suffered cerebral edema.

The special master also evaluated the significance of Monica’s brain weight

based on her height. In support of this assessment, the special master cited medical

studies showing that brain weight depends on age and height. For this purpose, the

special master estimated Monica’s height to be 23 inches. In doing so, the special

master credited the hospital’s measurement of 21.75 inches taken at Monica’s birth and

the growth differential reflected on her pediatric growth chart. The resulting estimate

was 2 inches shorter than the longest recorded length (25 inches) from Monica’s

autopsy, but longer than her pediatrician’s measurements. The special master noted

2009-5096 8
that the pediatrician could have been affected by the challenge of measuring a

squirming child. Based on her estimate, the special master found Monica exceeded the

average height for infants her age. In light of Monica’s above-average height, the

special master found Monica’s brain weight was “not out of proportion with her body

length and weight.”

Finally, the special master considered whether Monica’s post-vaccination

behavior was consistent with the expected signs and symptoms of encephalopathy.

Based on the testimony of government experts Dr. Gilbert-Barness and Dr. McCusker,

the special master concluded that Monica’s observed sleepiness and disinterest in

eating were not abnormal reactions. In support of this assessment, the special master

noted that neither Monica’s medical records nor any witness reported other symptoms

of encephalopathy following the vaccination, such as irritability, fever, vomiting, or

seizures. Though Dr. Shane opined that Monica’s behavior was “abnormal,” he

admitted that a pediatrician, such as government expert Dr. McCusker, would be better

qualified to render an opinion. Dr. McCusker testified that Monica’s reactions were

normal, without any of the clinically-recognized symptoms that precede severe

somnolence indicative of encephalopathy.

Finally, the special master cited other evidence in discounting Dr. Shane’s

conclusion that Monica’s brain was severely edematous. This evidence included Dr.

Anthony’s autopsy report, which found no edema except in the lungs. Dr. Anthony

opined that Monica’s brain was “grossly unremarkable,” with “no evidence of edema or

herniation.” Similarly, government expert Dr. Gilbert-Barness testified that she saw

“very little abnormality” in the autopsy slides of Monica’s brain and none of the changes

2009-5096 9
Dr. Shane described or attributed to edema. Though Dr. Gilbert-Barness agreed that

Monica had heavier than average organs, she disagreed as to the cause. According to

Dr. Gilbert-Barness, their heaviness did not have to be explained by edema, as Dr.

Shane suggested. Dr. Gilbert-Barness opined that organs could be heavy due to SIDS

caused by asphyxiation, in which blood vessels dilate and organs become congested

with blood.

Doe is correct that not all of the evidence in the record supports the special

master’s findings. That, however, is not the question. On appeal, we must determine

whether the special master’s findings of fact are supported by substantial evidence.

See Whitecotton by Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d 1099,

1105 (Fed. Cir. 1996). As chronicled in the Court of Federal Claims’ thorough opinion,

the special master conducted a detailed review of the testimony, medical records, and

medical literature. Thus, as an initial matter, we cannot say that the special master

failed to consider important aspects of the record. See 42 U.S.C. § 300aa-13(b)(1);

Hodges v. Sec’y of Dep’t of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)

(noting that the role of appellate review “is not to second guess the Special Master’s

fact-intensive conclusions; the standard of review is uniquely deferential for what is

essentially a judicial process”).

As for the specific factual findings, it was not arbitrary or capricious for the

special master to conclude that Monica’s brain was not significantly “edematous.” The

best support for Doe’s theory of causation, encephalopathy followed by cerebral edema,

was offered by Dr. Shane. The special master, however, chose not to credit Dr.

Shane’s testimony, because she found it unsupported by the facts of this particular

2009-5096 10
case. These facts included Dr. Anthony’s autopsy report, which described Monica’s

brain as “grossly unremarkable” with “no evidence of edema,” and the testimony of

expert Dr. Gilbert-Barness’s, who saw “very little abnormality” in the autopsy slides.

Because of the special master’s unique position to see the witnesses and hear their

testimony, such credibility assessments are “virtually unreviewable on appeal.” Lampe

v. Sec’y of Dep’t of Health & Human Servs., 219 F.3d 1357, 1362 (Fed. Cir. 2000); see

also 42 U.S.C. § 300aa-13(b)(1); Bradley v. Sec’y of Dep’t of Health & Human Servs.,

991 F.2d 1570, 1575 (Fed. Cir. 1993). We see no basis for disturbing the special

master’s credibility findings as to Dr. Shane, Dr. McCusker, or Dr. Gilbert-Barness. 2

We similarly conclude that the special master’s decision to evaluate Monica’s

brain weight in light of her height was not arbitrary or capricious. This decision was

supported by medical literature detailing a correlation between an infant’s height and

brain weight. Given the widely varying estimates of Monica’s height, the special master

did not err by choosing an estimate between the minimum and maximum heights

recorded. We cannot say that the special master’s careful weighing of this conflicting

evidence was “so clearly wrong as to be arbitrary or capricious.” Lampe, 219 F.3d at

1367.

2
Though both Dr. Gilbert-Barness and the special master cited a table of
brain weights based on children with moderate to severe brain edema, any error was
harmless. See Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1526 (Fed.
Cir. 1991). This table was not the only fact the special master relied on, or even the
most important one, in declining to credit Dr. Shane’s theory. To the contrary, the
special master’s decision was based on a number of factors, including the autopsy
results, Monica’s greater-than-average height, Dr. Gilbert-Barness’s review of the
autopsy slides, and Dr. Shane’s own testimony regarding the “top limit of normal.”

2009-5096 11
 Nor can we say that it was arbitrary or capricious for the special master to

conclude that Monica’s pre-death behavior and weight of her other organs failed to

support Dr. Shane’s encephalopathy diagnosis. The special master’s ultimate

conclusion was supported by the testimony of Dr. Gilbert-Barness and Dr. McCusker,

who both opined that Monica did not display other characteristic symptoms of

encephalopathy, such as vomiting, seizures, or fever. As Dr. Shane admitted, Dr.

McCusker was better qualified to offer an opinion on whether Monica’s sleepiness was

a normal reaction to the vaccine or the type of somnolence symptomatic of

encephalopathy. Dr. McCusker opined that Monica’s pre-death behavior was normal.

The special master credited this testimony, as well as the testimony of Monica’s father,

who observed no fever, vomiting, or seizures. It is not our role to reweigh the factual

evidence or assess whether the special master correctly evaluated the evidence. Munn

v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 871 (Fed. Cir. 1992).

Accordingly, we hold that the special master’s factual findings were not arbitrary

or capricious.

II. Evidence of Alternative Causes

We must also decide whether it was legal error under 42 U.S.C. § 300aa-

13(a)(2)(A) for the special master to consider evidence of alternative causes in

evaluating whether a prima facie case has been established in this off-Table case.

Specifically, Doe contends that the special master erred when discussing prong two of

the Althen test by considering evidence that SIDS, not the hepatitis B vaccine, caused

Monica’s death.

2009-5096 12
 In this case, both parties presented evidence about an alternative cause of

death, sudden infant death as the result of asphyxiation. In his expert report and at the

hearing, Dr. Shane opined that the circumstances surrounding Monica’s death and

pathological findings at the autopsy were “inconsistent with a SIDS death.” Dr. Shane

went on to explain why the extent of cerebral edema he observed in Monica’s brain,

absence of multi-organ findings, and lack of prior upper respiratory problems were

inconsistent with a SIDS death.

The government offered the testimony of Dr. Gilbert-Barness. She explained that

many deaths attributed to SIDS are now thought “very likely related” to the infant’s

sleeping position or bedding, with “most” related to an asphyxial death. In Monica’s

case, Dr. Gilbert-Barness opined that the nap environment created a risk of SIDS

caused by asphyxiation. She explained that the congestion of Monica’s abdominal

organs and over-distinction of the lungs’ alveoli were consistent with asphyxiation.

The medical literature in evidence states that “classic” findings in SIDS cases

include petechiae, pulmonary congestion and edema, heavy organs, and an empty

urinary bladder. Further, many of the infants who die of SIDS are tall for their age and

have brain weights exceeding the ninety-ninth percentile for their age group, without

evidence of cerebral edema. The special master noted that Monica displayed many of

these classic SIDS findings.

The special master considered this SIDS evidence, along with other testimony,

medical records, and medical literature in evaluating whether Doe’s medical theory

reflected a “logical sequence of cause and effect,” as required by prong two of the

Althen test. While noting some of the government’s evidence might also have been

2009-5096 13
relevant to a claim of alternative causation (i.e., SIDS) had Doe proved their prima face

case, the special master only considered evidence of SIDS “for the limited purpose of

evaluating carefully the reliability of the medical underpinnings of petitioners’ proposed

causal sequence for a vaccine injury.” Id.

Doe urges us to find fault with the special master considering any evidence of

SIDS, a possible alternative cause, in deciding whether Doe established a prima facie

case. Doe argues that such consideration is prohibited by 42 U.S.C. § 300aa-13(a).

Section 300aa-13(a) establishes the terms for awarding compensation. It provides that

“on the record as a whole,” the special master must find (1) the petitioner “has

demonstrated by a preponderance of evidence the matters required in the petition by

section 300aa-11(c)(1),” and (2) “there is not a preponderance of evidence that the . . .

death described in the petition is due to a factor unrelated to the administration of the

vaccine described in the petition.” 42 U.S.C. § 300aa-13(a)(1) (emphasis added).

The first requirement, demonstrating “the matters required by [42 U.S.C.

§ 300aa-11(c)(1)],” is what this court refers to as the petitioner’s prima facie case. See,

e.g., Walther, 485 F.3d at 1149; see also de Bazan, 539 F.3d at 1351; Pafford v. Sec’y

of Health & Human Servs., 451 F.3d 1352, 1357 (Fed. Cir. 2006). To make out a prima

facie case, the petitioner must show that the person received a vaccine set forth in the

Vaccine Injury Table and sustained an illness, disability, injury, or condition caused by

that vaccine. 42 U.S.C. § 300aa-11(c)(1). The second inquiry under § 300aa-13(a)(1)

is whether the injury or death was due to a “factor unrelated” to the vaccination. While

the burden of proving a prima facie case is on the petitioner, the government has the

2009-5096 14
burden of showing the injury or death was caused by a “factor unrelated.” Id. § 300aa-

13(a)(1)(B); see also de Bazan, 539 F.3d at 1352-54; Walther, 485 F.3d at 1150.

As relevant here, subsection (2) of § 300aa-13(a) limits the definition of “factors

unrelated” by excluding any “idiopathic, unexplained, unknown, hypothetical or

undocumentable cause, factor, injury, illness or condition.” In other words, alternative

causes that are “idiopathic, unexplained, unknown, hypothetical or undocumentable”

cannot overcome a petitioner’s prima facie case. 42 U.S.C. § 300aa-13(a)(1), (2). Nor

can the special master require the petitioner to eliminate alternative causes as part of

establishing its prima facie case.

These restrictions on the second inquiry under § 300aa-13(a), however, are not

implicated in this case. They are not at issue because Doe never established a prima

facie case, so the burden (and attendant restrictions on what “factors unrelated” the

government could argue) never shifted. Doe IV, 87 Fed. Cl. at 12; see Pafford, 451

F.3d at 1357-59; cf. Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344 (Fed

Cir. 1999).

Accordingly, the questions here are different. They are whether the government

may present evidence of alternative causes, and what limits, if any, constrain the

special master’s consideration of such evidence in evaluating the petitioner’s prima facie

case. By its plain terms, § 300aa-13 does not prohibit the government from presenting

evidence of alternative causes. Instead, “like any defendant, [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, 539 F.3d at 1353.

2009-5096 15
 As for what the special master may do, neither § 300aa-13 nor our cases limit

what evidence the special master may consider in deciding whether a prima facie case

has been established. See de Bazan, 539 F.3d at 1353; see also Walther, 485 F.3d at

1151. Indeed, § 300aa-13(a) requires the special master’s findings to be based “on the

record as a whole.” Thus, in de Bazan the government could present, and the special

master could consider, evidence that petitioner’s symptoms occurred too early to have

been caused by the vaccine when evaluating petitioner’s prima facie case, even though

that evidence undermined petitioner’s theory of causation. Id.

In this case, the special master did not commit legal error by considering

evidence that Monica’s death could have been caused by SIDS. Part of the evidence

Doe offered was Dr. Shane’s expert testimony, which attempted to eliminate SIDS as a

potential cause of death. Specifically, Dr. Shane opined that Monica’s death and the

pathological findings at her autopsy were “inconsistent with a SIDS death.” As this court

explained in Walther, when petitioners attempt to eliminate other possible causes to

buttress their theory of causation, the special master should evaluate such evidence in

determining whether a prima facie case has been established. 485 F.3d at 1151; see

also Pafford, 451 F.3d at 1359. Because Dr. Shane supported his theory of causation

by discounting SIDS as a possible cause, Doe’s prima facie case depended in part on

whether the special master credited Dr. Shane’s opinion on SIDS. Evidence of SIDS

thus “bore directly on whether the medical evidence supported [a conclusion] that the

vaccine could be the cause in fact”; the special master’s consideration of this evidence

was both warranted and proper. de Bazan, 539 F.3d at 1354.

2009-5096 16
 Allowing the special master to consider evidence of SIDS did not improperly shift

the burden to Doe to rule out alternative causes. Evidence of SIDS was just one factor

among many that the special master relied on in concluding that “the facts of the case”

did not support Doe’s theory of causation, and thus failed to establish a prima facie

case. See § 300aa-13(a)(1). A petitioner’s failure to meet his burden of proof as to the

cause of an injury or condition is different from a requirement that he affirmatively

disprove an alternative cause. See de Bazan, 539 F.3d at 1353-54. The special master

denied compensation because she determined that Doe failed to establish a prima facie

case of causation based on a review of Doe’s proposed theory in light of all the

evidence, not because Doe failed to eliminate SIDS as an alternative cause of Monica’s

death.

CONCLUSION

For the foregoing reasons, we hold that the special master’s fact finding was not

arbitrary or capricious. Further, the special master’s evaluation of the SIDS evidence

was not contrary to law, as set out in § 300aa-12(a)(2)(E) or de Bazan. The judgment

of the Court of Federal Claims is affirmed.

AFFIRMED

COSTS

Each party shall bear its own costs.

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