Hibbard v. Secretary of Health & Human Services

United States Court of Appeals

for the Federal Circuit

__________________________

JENNIFER HIBBARD,

Petitioner-Appellant,

v.

SECRETARY OF HEALTH AND HUMAN

SERVICES,

Respondent-Appellee.

__________________________

2012-5007

__________________________

Appeal from the United States Court of Federal

Claims in Case No. 07-VV-446, Judge Thomas C.

Wheeler.

___________________________

Decided: November 2, 2012

___________________________

SYLVIA CHIN-CAPLAN, Conway, Homer & Chin-Caplan,

P.C. of Boston, Massachusetts, argued for petitioner-

appellant. On the brief was RONALD C. HOMMER.

GLENN A. MACLEOD, Senior Trial Counsel, Torts

Branch, Civil Division, United States Department of

Justice, of Washington, DC, argued for respondent-

appellee. With him on the brief were TONY WEST, Assis-

tant Attorney General, MARK W. ROGERS, Acting Director,

HIBBARD v. HHS 2

VINCENT J. MATANOSKI, Acting Deputy Director and

GABRIELLE M. FIELDING, Assistant Director.

__________________________

Before LOURIE, BRYSON, and O’MALLEY, Circuit Judges.

Opinion for the court filed by Circuit Judge BRYSON.

Dissenting opinion filed by Circuit Judge O’MALLEY.

BRYSON, Circuit Judge.

Jennifer Hibbard received a flu vaccination in 2003.

She claims that the flu vaccine caused her to develop a

neurological disorder known as dysautonomia, a dysfunc-

tion of the autonomic nervous system. Her theory is that

the vaccine provoked an immune reaction that damaged

her autonomic nerves, and that the injury to her auto-

nomic nerves, known as autonomic neuropathy, resulted

in her dysautonomia. She seeks compensation for her

injury under the National Childhood Vaccine Injury Act of

1986 (“the Vaccine Act”), 42 U.S.C. §§ 300aa-1 to 300aa-

34.

The parties agree that Ms. Hibbard suffers from dy-

sautonomia; the dispute between the parties is whether

her dysautonomia is the result of autonomic neuropathy

caused by the vaccine. Following a two-day hearing, a

special master found that Ms. Hibbard had failed to show

that her dysautonomia resulted from autonomic neuropa-

thy caused by the vaccine she received in 2003. Accord-

ingly, the special master found that she failed to meet her

burden of demonstrating by a preponderance of the evi-

dence that the vaccine resulted in a compensable injury,

as required by the Act, 42 U.S.C. §§ 300aa-13(a)(1)(A) and

300aa-11(c)(1)(C)(ii)(I). On review, the Court of Federal

Claims upheld the special master’s decision. We affirm.

3 HIBBARD v. HHS

I

Ms. Hibbard was 41 years old and working as a first-

grade teacher when she experienced a fainting spell in

May 2003. She felt a wave of heat and lightheadedness,

and she lost consciousness for approximately 10 seconds.

She was taken to an emergency room; a neurological

examination and laboratory tests were normal, and she

was discharged that day. No specific tests were con-

ducted for dysautonomia at that time. The respondent’s

expert later testified that the May episode was an in-

stance of dysautonomia, and Ms. Hibbard’s expert agreed

that the episode was a symptom of autonomic dysfunc-

tion. When Ms. Hibbard saw her primary care physician

in July 2003, she had recovered, but she reported that it

took about a month after the fainting spell before she felt

normal again. At the time of the May episode, Ms.

Hibbard reported that in the past she had experienced

other incidents of fainting or feeling lightheaded.

Several months later, on November 1, 2003, Ms.

Hibbard received a flu vaccination. A week after the

vaccination, Ms. Hibbard began to feel tired, achy, and

nauseated. Her symptoms worsened during an extracur-

ricular outing with some of her students and continued

over the next few days. On November 11, she saw a

physician, who prescribed antibiotics for what he believed

was probably “[e]volving sinusitis.” He also noted that

Ms. Hibbard probably had “some underlying viral respira-

tory infection.” The antibiotics did not alleviate Ms.

Hibbard’s symptoms, and during the following week she

saw two other doctors, including her primary care physi-

cian, Dr. Amy Schoenbaum. Ms. Hibbard reported that

she felt very weak, tired, and dizzy, especially when

standing. Based on a recommendation of one of those

doctors, Ms. Hibbard stopped taking the antibiotics. Both

HIBBARD v. HHS 4

doctors thought that a viral infection might be responsible

for her symptoms.

Ms. Hibbard continued to follow up with Dr.

Schoenbaum. On December 12, 2003, Dr. Schoenbaum

noted that Ms. Hibbard presented with complaints of

“vertigo, weakness, feeling of passing out, some heaviness

and numbness in her extremities.” Dr. Schoenbaum sent

her to an emergency room at that time, where she was

referred to a neurologist. The neurologist considered

Guillain-Barré Syndrome (“GBS”) as a possible diagnosis

but concluded that GBS was unlikely based on Ms.

Hibbard’s medical history and physical examination. Ms.

Hibbard returned to the emergency room the following

day because she was having trouble breathing. She was

admitted to the hospital at that time with a diagnosis of

“malaise,” which remained her principal diagnosis when

she was discharged several days later. Over the next few

months, Ms. Hibbard saw an otoneurologist for vestibular

testing, which did not reveal anything abnormal. Ms.

Hibbard also began seeing a psychiatrist, who initially

prescribed selective serotonin reuptake inhibitor treat-

ment. When Ms. Hibbard did not tolerate that treatment

well, her psychiatrist prescribed a different antidepres-

sant.

Ms. Hibbard’s dizziness and weakness continued, and

she saw Dr. Schoenbaum again on February 27, 2004. Dr.

Schoenbaum encouraged Ms. Hibbard to continue work-

ing with her psychiatrist, because although her symptoms

were “not classic for an anxiety disorder,” she was “ex-

periencing anxiety and depression secondary to the symp-

toms.” Over the next several months, Ms. Hibbard saw a

cardiologist and two neurologists. The cardiologist

checked for mitral valve prolapse, for which Ms. Hibbard

had been treated in the past, but found no definitive

5 HIBBARD v. HHS

evidence of that condition. The first of the two neurolo-

gists, Dr. Louis Caplan, concluded that Ms. Hibbard had

“a postinfectious neuropathy with autonomic features,”

which he referred to as “kind of a Guillain Barré with

partial dysautonomia.” The second neurologist was Dr.

Kenneth Gorson, an expert in GBS. Dr. Gorson reported

that Ms. Hibbard’s detailed neurological examination was

normal and that the “[r]outine nerve conduction studies

were pristine.” Based on his examination, Dr. Gorson

concluded that Ms. Hibbard did not have “electrophysi-

ologic features, nor clinical features, of typical [GBS],” but

he added that it was “certainly possible that she devel-

oped a modest dysautonomic neuropathy following a

nonspecific viral illness or even the flu vaccination back in

November.” He noted that some patients with a condition

known as Postural Orthostatic Tachycardia Syndrome

(“POTS”) have symptoms similar to Ms. Hibbard’s.

The record indicates that POTS is a syndrome in

which the patient’s heart rate increases significantly upon

standing without a significant drop in blood pressure.

POTS is indicative of dysautonomia, but it is a nonspecific

finding. While it can be associated with autonomic neu-

ropathy, it can have other causes as well. To test for

POTS, Dr. Gorson recommended a tilt table test.

On June 16, 2004, Ms. Hibbard underwent a series of

tests of her autonomic nervous system, including a tilt

table test. The tests were conducted by Dr. Christopher

Gibbons under the supervision of Dr. Roy Freeman, a

leading expert on autonomic dysfunction. The tests

resulted in a diagnosis of POTS. In addition to showing

the presence of orthostatic tachycardia (rapid heart rate

upon standing), the tilt table test revealed some drop in

blood pressure when Ms. Hibbard was elevated into the

standing position. The testing also showed “an exagger-

HIBBARD v. HHS 6

ated postural tachycardia . . . on active standing” and

“symptoms of lightheadedness and shortness of breath

while standing.” The results of the other autonomic tests

that Dr. Gibbons and Dr. Freeman administered to Ms.

Hibbard were all in the normal range.

In their report, Drs. Gibbons and Freeman stated that

the overall study was “abnormal” in that “one measure of

sympathetic adrenergic function [the tilt table test for

POTS] was in the pathologic range,” although the meas-

ures of the “sympathetic cholinergic function were in the

normal range.” They reported that the tests showed

“evidence of an exaggerated postural tachycardia.” Al-

though they identified that finding as “a non-specific

finding,” they added that “exaggerated postural tachycar-

dia has been associated with mild or early autonomic

neuropathy and an autonomic neuropathy that involves

the distal vasculature sparing the cardiac autonomic

innervation.” They added that “[o]ther associations have

included cardiovascular deconditioning, cardiac beta

adrenoreceptor supersensitivity and mitral valve

prolapse,” that “fever, volume depletion and dehydration

should be excluded,” and that the same response has been

seen “in patients diagnosed with chronic fatigue syn-

drome.” Dr. Freeman concluded from the testing that “it

is unclear . . . the extent to which autonomic dysfunction

is contributing to her symptoms.”

Ms. Hibbard followed up with another neurologist, Dr.

Peter Novak. As part of his evaluation, Dr. Novak per-

formed another tilt table test. That test again revealed

orthostatic tachycardia. Dr. Novak’s assessment of the

tests was that they showed “moderate cardiac adrenergic

and vasomotor adrenergic impairment with normal

cardiac cholinergic functions,” findings that he found to be

7 HIBBARD v. HHS

“suggestive of the autonomic neuropathy affecting pre-

dominantly sympathetic (adrenergic) fibers.”

II

On June 28, 2007, Ms. Hibbard filed a petition for

compensation under the Vaccine Act. Initially, she

claimed that she suffered from GBS, caused by the flu

vaccine. She later amended her petition to allege that she

had suffered a neurological demyelinating injury. In

support of her petition, Ms. Hibbard submitted an expert

report from Dr. Thomas Morgan, a neurologist. The

respondent submitted an expert report from another

neurologist, Dr. Vinay Chaudhry.

The experts explained that the human nervous sys-

tem is divided between the central nervous system, which

refers to the brain and spinal cord, and the peripheral

nervous system, which includes the rest of the nervous

system. The peripheral nervous system includes the

autonomic nervous system, which controls involuntary

functions such as heart rate, respiratory rate, and perspi-

ration. The autonomic nervous system is further divided

between the sympathetic component and the parasympa-

thetic component, which together keep the body’s internal

systems in balance, a condition known as “homeostasis.”

In his initial report, Dr. Morgan stated that it was his

medical opinion, based on Ms. Hibbard’s medical records,

that she “sustained a post influenza vaccine immuniza-

tion autonomic neuropathy with signs and symptoms well

documented in the record of dysautonomia.” Dr. Morgan

noted that several of Ms. Hibbard’s symptoms involved

the sympathetic nervous system, including POTS, or-

HIBBARD v. HHS 8

thostatic hypotension,1 and sweating abnormalities. He

also noted some parasympathetic symptoms, including

“nasal sinus secretions, flushing, gastrointestinal motility

problems, nausea, vomiting, diarrhea and constipation.”

Dr. Morgan stated that Ms. Hibbard’s condition was

consistent with a variant of GBS known as pandy-

sautonomia, which he explained can be caused by “mo-

lecular mimicry,” in which a vaccine generates an

immune response that attacks the sympathetic nerve

fibers to cause symptoms of dysautonomia. He added that

the development of symptoms of autonomic neuropathy

within ten days to two weeks after the vaccination is

consistent with an autoimmune reaction caused by a

vaccine.

Dr. Chaudhry stated that it was difficult to explain all

of Ms. Hibbard’s symptoms with a single diagnosis. While

Dr. Chaudhry acknowledged that GBS “may rarely pre-

sent with autonomic manifestations as the sole or pre-

dominant feature,” he stated that autonomic

manifestations usually would be accompanied by or-

thostatic hypotension, which is a drop in blood pressure

upon standing without a corresponding rise in heart rate.

He described orthostatic hypotension as not being docu-

mented in Ms. Hibbard’s case. Dr. Chaudhry also noted

that “[g]enerally [POTS] is a chronic syndrome and not an

acute neuropathy like GBS.” In light of Ms. Hibbard’s

symptoms, her normal examination, the limited documen-

tation of abnormalities of autonomic function, her prior

history of fainting, and the multiple other possible diag-

noses, Dr. Chaudhry concluded that Ms. Hibbard did not

1 Orthostatic hypotension was defined by one of the

references in the record as a reduction of systolic blood

pressure of at least 20 mm Hg or diastolic blood pressure

of at least 10 mm Hg within three minutes of standing.

9 HIBBARD v. HHS

“represent[] a GBS syndrome presenting as autonomic

neuropathy.” He added that her symptoms were “far

more than can be explained by” a possible “mild or early

autonomic neuropathy.” For those reasons, Dr. Chaudhry

concluded that there was “no causal link between the flu

vaccine and her multiple symptoms.”

In a supplemental report, Dr. Chaudhry responded to

Dr. Morgan’s report by stating that in his opinion “[t]here

is no objective sign or laboratory test that has demon-

strated that Ms. Hibbard has peripheral neuropathy from

molecular mimicry or any other hypothesis.” Specifically,

Dr. Chaudhry noted that Ms. Hibbard displayed “no

sensory loss, weakness, or reflex change,” that a skin

biopsy test of small sensory fibers and nerve conduction

studies of the large sensory and motor fibers were normal,

and that no spinal fluid changes were documented. He

added that the autonomic laboratory tests that were

performed on Ms. Hibbard did not indicate that she was

suffering from autonomic neuropathy.

The special master who was assigned to the case held

a two-day hearing. During the hearing, Dr. Morgan

explained the rationale for his opinion that Ms. Hibbard

suffered from autonomic neuropathy. Important to his

conclusion was a Mayo Clinic study that described a

retrospective study of POTS patients in an attempt to

determine the cause of POTS. The authors of that study

were specifically interested in determining the extent to

which POTS was associated with autonomic neuropathy.

The authors concluded that at least half of the POTS

patients they studied had neuropathic features, and that

about 50 percent of the patients who were tested had

“evidence of peripheral sudomotor denervation.” Sudomo-

tor denervation involves impaired sudomotor function

(sweat gland function in response to stimulation).

HIBBARD v. HHS 10

Dr. Chaudhry testified that the tests for autonomic

neuropathy that were performed on Ms. Hibbard were

negative, including the “skin sympathetic response test,”

Valsalva maneuver testing, and catecholamine level

testing. Based on those tests, Dr. Chaudhry concluded

that although Ms. Hibbard suffers from autonomic dys-

function, there were “so many symptoms with very little

signs” that it is “hard to put this together and say this is

autonomic neuropathy.” Although Dr. Morgan in his

initial report had identified several of Ms. Hibbard’s

symptoms as signs of autonomic neuropathy, in his testi-

mony at the hearing he acknowledged that other than the

tests for POTS, the objective tests for autonomic neuropa-

thy in the sympathetic nerves were normal.

Following the hearing, the special master directed the

parties to submit post-hearing briefs focusing on the

issues that appeared to be the focus of the dispute. The

special master referred to this court’s decision in Althen v.

Secretary of Health & Human Services, which requires

the petitioner in a Vaccine Act case to show “(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 show-

ing of a proximate temporal relationship between vaccina-

tion and injury.” 418 F.3d 1274, 1278 (Fed. Cir. 2005). As

to the first element of the Althen test, the special master

invited the parties to comment on what he understood to

be Dr. Morgan’s medical theory as to how the flu vaccine

could have caused Ms. Hibbard’s condition—that through

a process known as molecular mimicry, the vaccine had

triggered a response that damaged the myelin around the

pre-ganglionic portion of the sympathetic part of Ms.

Hibbard’s autonomic nervous system. As to the second

part of the Althen test, the special master directed the

parties to explain whether Ms. Hibbard had presented a

11 HIBBARD v. HHS

“logical sequence of cause and effect” by which the flu

vaccine led to her condition. The special master explained

that if Dr. Morgan’s theory is “that the flu vaccine can

lead to demyelination, which is damage to nerves, . . . it

appears that petitioner needs to establish, by a prepon-

derance of the evidence that she suffered from an auto-

nomic neuropathy.” As to the third part of the Althen

test, the special master noted that respondent’s expert

had conceded that Ms. Hibbard’s case satisfied the tempo-

ral relationship factor. In light of that concession, the

special master did not require the parties to address the

timing issue.

In response, Ms. Hibbard agreed with the special

master’s characterization of her “molecular mimicry”

theory of causation, except that she added that the injury

to her nerves could have occurred in an unmyelinated

area of the sympathetic nervous system. She explained:

“Where there is myelin, the mimicry could have been with

the myelin. Where it is unmyelinated, the mimicry could

have been with the proteins contained in the ganglia.”

After receiving the parties’ briefs, the special master

issued a decision denying compensation for Ms. Hibbard.

Although both parties (and the special master) agreed

that Ms. Hibbard suffers from dysautonomia and that she

has POTS, the special master found that “[a] preponder-

ance of the evidence supports a finding that Ms. Hibbard

does not have autonomic neuropathy.” The special master

based that conclusion on his finding that “when Ms.

Hibbard was tested for signs of autonomic neuropathy,

the results were normal.” With respect to Dr. Morgan’s

reliance on the fact that Ms. Hibbard suffers from POTS

as indicating damage to the sympathetic nervous system,

the special master noted that POTS “does not always

mean that the nerves in the autonomic nervous system

HIBBARD v. HHS 12

are damaged,” and that Dr. Morgan had failed “to account

for the substantial number of people who have POTS

without autonomic neuropathy.”

Because Ms. Hibbard’s theory was that the flu vaccine

caused an autoimmune reaction that damaged her sympa-

thetic nerves resulting in dysautonomia, the special

master found that Ms. Hibbard’s failure to prove that she

had autonomic neuropathy doomed her case. Having

found that Ms. Hibbard failed to prove that critical step in

Dr. Morgan’s medical theory of causation, the special

master concluded that Ms. Hibbard did not satisfy the

second part of the Althen test, i.e., she failed to show that

there was a logical sequence of cause and effect showing

that the vaccine was the reason for her injury. For that

reason, the special master stated that it was not neces-

sary to address the other Althen factors.

The Court of Federal Claims affirmed the special

master’s decision. The court described Ms. Hibbard’s

theory of causation as follows: “the flu vaccine, through

molecular mimicry, caused autonomic neuropathy, which

manifested as dysautonomia and POTS.” In light of that

theory of causation, the court ruled, the special master

did not commit legal error by deciding the case solely on

the issue of whether Ms. Hibbard has autonomic neuropa-

thy, which the court described as “the underpinning on

which Ms. Hibbard’s entire case hinges.” As to that issue,

the court concluded that the special master’s finding of

fact was not arbitrary and capricious. The court observed

that although several of the physicians who examined Ms.

Hibbard suspected autonomic neuropathy as a possible

cause of her dysautonomia, the medical evidence was

inconclusive. In particular, the court noted, the special

master had relied heavily on objective test results, which

for the most part were negative as to signs of autonomic

13 HIBBARD v. HHS

neuropathy. The court therefore upheld the special

master’s finding that Ms. Hibbard did not suffer from

autonomic neuropathy.

III

In Vaccine Act cases, we review a ruling by the Court

of Federal Claims de novo, applying the same standard

that it applies in reviewing the decision of the special

master. Cloer v. Sec’y of Health & Human Servs., 654

F.3d 1322, 1330 (Fed. Cir. 2011) (en banc); Moberly v.

Sec’y of Health & Human Servs., 592 F.3d 1315, 1321

(Fed. Cir. 2010). Therefore, we review the rulings of the

special master to determine whether they were “arbitrary,

capricious, an abuse of discretion, or otherwise not in

accordance with law.” Munn v. Sec’y of Health & Human

Servs., 970 F.2d 863, 869 (Fed. Cir. 1992).

The role of appellate review of a special master’s deci-

sion under the arbitrary and capricious standard “is not

to second guess the Special Master’s fact-intensive con-

clusions; the standard of review is uniquely deferential for

what is essentially a judicial process.” Locane v. Sec’y of

Health & Human Servs., 685 F.3d 1375, 1380 (Fed. Cir.

2012), quoting Hodges v. Sec’y of Health & Human Servs.,

9 F.3d 958, 961 (Fed. Cir. 1993); Doe v. Sec’y of Health &

Human Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010). If

the special master’s conclusion is “based on evidence in

the record that [is] not wholly implausible, we are com-

pelled to uphold that finding as not being arbitrary and

capricious.” Cedillo v. Sec’y of Health & Human Servs.,

617 F.3d 1328, 1338 (Fed. Cir. 2010), quoting Lampe v.

Sec’y of Health & Human Servs., 219 F.3d 1357, 1360

(Fed. Cir. 2000). Put another way, if the special master

“has considered the relevant evidence of record, drawn

plausible inferences and articulated a rational basis for

HIBBARD v. HHS 14

the decision, reversible error will be extremely difficult to

demonstrate.” Hines v. Sec’y of the Dep’t of Health &

Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991).

Because Ms. Hibbard’s injury is not listed on the Vac-

cine Injury Table, 42 U.S.C. § 300aa-14(a), this is an off-

Table case. Moberly, 592 F.3d at 1321-22; Althen, 418

F.3d at 1278. As such, Ms. Hibbard was required to

prove, by a preponderance of the evidence, that the vac-

cine was “not only a but-for cause of the injury but also a

substantial factor in bringing about the injury.” Shyface

v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352

(Fed. Cir. 1999).

Ms. Hibbard acknowledges in her brief that it is her

burden “to show, by a preponderance of the evidence, in

accordance with [section 300aa-11(c)(1)(C)(ii)], that her

dysautonomia is more likely than not due to her flu

vaccine.” Her theory of causation is that the vaccine

provoked her immune system to attack her autonomic

nerves, causing damage to those nerves that manifested

as dysautonomia. Although at points in her brief Ms.

Hibbard argues that she was not required to show that

she suffers from autonomic neuropathy, her counsel

acknowledged at oral argument that in order for Ms.

Hibbard to recover, “she has to show that she has auto-

nomic neuropathy.” In light of her expert’s theory of

causation, which depended on a showing of autonomic

neuropathy, it was plainly necessary for her to make that

showing in order to satisfy the second of the Althen fac-

tors, which requires demonstrating “a logical sequence of

cause and effect showing that the vaccination was the

reason for the injury,” Althen, 418 F.3d at 1278.2

2 The dissent acknowledges that as part of her

prima facie case Ms. Hibbard was required to show causa-

15 HIBBARD v. HHS

A

Ms. Hibbard argues at some length that it was im-

proper for the special master to focus on the second Al-

then factor, to the exclusion of the other two factors. We

discern no error in the manner in which the special mas-

ter chose to address the Althen factors, however. The

special master acknowledged that the temporal require-

ment (the third Althen factor) was satisfied in this case.

He therefore had no need to discuss that factor in any

detail. As to the requirement that Ms. Hibbard show a

“medical theory causally connecting the vaccination and

the injury” (the first Althen factor), the special master

proceeded by assuming the medical viability of Dr. Mor-

gan’s theory of causation and going directly to the second

Althen factor, i.e., determining whether Dr. Morgan’s

theory accounted for Ms. Hibbard’s injury.

In arguing that the special master improperly short-

circuited the Althen analysis, Ms. Hibbard insists that it

was the special master’s “obligation to determine whether

a flu vaccine can cause dysautonomia and whether it did

so in [her] individual case.” In this case, she contends,

“the special master preemptively determined that an

tion by a preponderance of the evidence. See Doe, 601

F.3d at 1357 (citing cases). Given that Ms. Hibbard has

conceded that in order to satisfy her burden of proof she

had to show that she has autonomic neuropathy, it is not

clear why the dissent regards it as improper for the

special master to have focused on whether she succeeded

in doing so. Although the dissent complains that the

special master should have viewed Ms. Hibbard’s condi-

tion as dysautonomia rather than autonomic neuropathy,

her theory of causation was that the vaccine caused

autonomic neuropathy, which manifested as dysautono-

mia, so it was necessary for her to prove that her dy-

sautonomia resulted from autonomic neuropathy.

HIBBARD v. HHS 16

autonomic neuropathy did not cause [her] dysautonomia.”

Although she claims that the special master erred by

“attacking one element of [her] proposed theory of how

her injury occurred,” it was not error for the special

master to focus first on whether she actually had the

injury that she claims was caused by the vaccine before

addressing the question whether the vaccine actually

caused that injury in her case. If a special master can

determine that a petitioner did not suffer the injury that

she claims was caused by the vaccine, there is no reason

why the special master should be required to undertake

and answer the separate (and frequently more difficult)

question whether there is a medical theory, supported by

“reputable medical or scientific explanation,” by which a

vaccine can cause the kind of injury that the petitioner

claims to have suffered. Althen, 418 F.3d at 1278.

In previous cases, this court has sanctioned an ap-

proach similar to the one taken in this case, in which a

special master has addressed the nature of the injury

suffered before addressing the question whether there is a

viable medical theory by which a vaccine can cause the

injury claimed by the petitioner. See Locane, 685 F.3d

1375; Lombardi v. Sec’y of Health & Human Servs., 656

F.3d 1343 (Fed. Cir. 2011); Brockelschen v. Sec’y of Health

& Human Servs., 618 F.3d 1339 (Fed. Cir. 2010). In each

of those cases, there was a dispute as to the nature of the

petitioner’s injury, and in each case the special master’s

findings on the nature of the injury that the petitioner

incurred was sufficient to resolve the case because the

special master found that the injury the petitioner in-

curred was not one that could have been vaccine-induced

according to the petitioner’s medical theory.

The issue that the special master addressed in this

case is whether Ms. Hibbard suffers from autonomic

17 HIBBARD v. HHS

neuropathy. As Dr. Morgan’s report and testimony made

clear, that was a necessary component of her theory of

vaccine-induced injury. Therefore, even assuming the

medical plausibility of Ms. Hibbard’s theory of causa-

tion—that the vaccine triggered an immune response that

damaged her autonomic nerves—her failure to show that

she had autonomic neuropathy would be fatal to her case.

Given that Ms. Hibbard had to show both the medical

plausibility of her theory of causation and that she suf-

fered an injury consistent with that theory of causation,

there was no reason to require the special master to

address the first question when the answer to that ques-

tion could have no possible effect on the outcome of the

case. As the Court of Federal Claims succinctly put it,

Ms. Hibbard asserts that the flu vaccine, through

molecular mimicry, caused autonomic neuropathy,

which manifested as dysautonomia and POTS. . . .

The special master, therefore, did not commit le-

gal error by deciding Ms. Hibbard’s case solely on

the issue of whether she has autonomic neuropa-

thy, the underpinning on which Ms. Hibbard’s en-

tire case hinges.

Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl.

742, 749 (2011).

B

Ms. Hibbard makes the separate legal argument that

the special master and the trial court imposed an unduly

high burden of proof on her by requiring her to show

actual causation in this case. Instead, she argues, the

Althen standard of causation is satisfied—and should

have been regarded as met in this case—by proof that the

vaccine she received can cause the injury she suffered,

HIBBARD v. HHS 18

that the onset of her symptoms occurred within an appro-

priate time period, and that “no likely alternative cause of

her injury has been identified.”

This court has previously rejected the same argu-

ment—that proof that an injury could be caused by a

vaccine and that the injury occurred within an appropri-

ate period of time following the vaccination is sufficient to

require an award of compensation unless the respondent

can prove some other cause for the injury. See Moberly,

592 F.3d at 1323 (“temporal association between a vacci-

nation and a seizure, together with the absence of any

other identified cause for the ultimate neurological injury”

is evidence of causation but does not by itself compel a

finding of causation); Althen, 418 F.3d at 1278 (“neither a

mere showing of a proximate temporal relationship be-

tween vaccination and injury, nor a simplistic elimination

of other potential causes of the injury suffices, without

more, to meet the burden of showing actual causation”).

To the extent that Ms. Hibbard argues that the court’s

decision in Althen relieves petitioners of the obligation to

show actual causation, this court has rejected that con-

tention. Instead, the court has repeatedly held that in off-

Table cases such as this one the task of the special master

is to determine, “based on the record evidence as a whole

and the totality of the case, whether it has been shown by

a preponderance of the evidence that a vaccine caused the

[petitioner’s] injury.” Porter v. Sec’y of Health & Human

Servs., 663 F.3d 1242, 1249-50 (Fed. Cir. 2011), quoting

Lombardi, 656 F.3d at 1351; Stone v. Sec’y of Health &

Human Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012);

Moberly, 592 F.3d at 1321-22; Andreu v. Sec’y of Health &

Human Servs., 569 F.3d 1367, 1382 (Fed. Cir. 2009).

19 HIBBARD v. HHS

In the recent en banc decision in Cloer v. Secretary of

Health & Human Services the court once again made

clear that Althen does not lessen the ultimate burden of

proof on a petitioner to show actual causation by a pre-

ponderance of the evidence. In Cloer, the court character-

ized Althen as setting forth “three pleading requirements

for a non-Table injury petition,” Cloer, 654 F.3d at 1333

n.4, and it noted that the Althen “pleading burden is, of

course, lower than the preponderance burden that must

be met in order to receive compensation.” Id. at 1331 n.3.

Thus, by characterizing the Althen factors as “pleading

requirements,” and emphasizing that a petitioner must

ultimately satisfy the preponderance burden in order to

obtain an award of compensation, Cloer supports the

decision of the special master and the Court of Federal

Claims in this case, which applied the preponderance test

to the issue of causation, and not a lesser standard as

urged by Ms. Hibbard.

C

Ms. Hibbard’s final argument is that the evidence in

this case points so decidedly in her favor that the special

master’s conclusion that “[a] preponderance of the evi-

dence supports a finding that Ms. Hibbard does not have

autonomic neuropathy” is arbitrary and capricious.

Based on the evidence of record and the factual findings

the special master made following the two-day eviden-

tiary hearing, we reject Ms. Hibbard’s contention that the

special master’s decision denying compensation was so

plainly contrary to the evidence that it must be reversed

even under the uniquely deferential arbitrary and capri-

cious standard of review.

The special master found that Ms. Hibbard has POTS

but concluded that she failed to show that her POTS was

HIBBARD v. HHS 20

caused by autonomic neuropathy. He based that conclu-

sion on the fact that the various objective tests for auto-

nomic neuropathy that were conducted in Ms. Hibbard’s

case were all negative. Dr. Chaudhry summarized the

results of the objective testing for autonomic neuropathy

as follows: Except for the tests confirming that Ms.

Hibbard has POTS, the remaining tests for autonomic

neuropathy in the sympathetic nervous system—tests for

orthostatic hypotension, skin sympathetic response,

Valsalva maneuver, catecholamine levels, vasomotor

function, and sweating abnormalities—were all normal.

The tests for abnormalities in the parasympathetic nerv-

ous system were likewise normal, except for one test that

produced borderline results but on subsequent testing

returned to normal. As the special master summarized,

apart from the fact that she suffers from POTS, “there are

no signs that Ms. Hibbard has autonomic neuropathy.”

The special master accepted the experts’ testimony

that the Mayo Clinic study indicated that approximately

50 percent of all POTS patients have a limited form of

autonomic neuropathy. He further found, however, that

the evidence of record did not suggest that Ms. Hibbard

was among the half of POTS patients with autonomic

neuropathy. As the special master explained, “Ms.

Hibbard did not have other problems that people who

have POTS associated with an autonomic neuropathy

have. For example, Ms. Hibbard did not have low blood

pressure when standing, heart rate variation with deep

breathing, sweating abnormalities, or an abnormal skin

sympathetic test.” Many of the POTS patients in the

Mayo Clinic study had other indicators of autonomic

neuropathy. For example, the Mayo Clinic paper reported

that approximately half the patients in the study who

were tested for sudomotor denervation tested positive for

that condition, which is a sign of autonomic neuropathy.

21 HIBBARD v. HHS

By contrast, Ms. Hibbard tested negative on tests for

sudomotor denervation, as well as on all the other objec-

tive tests for autonomic neuropathy that were performed

on her. In light of the fact that Ms. Hibbard, unlike many

of the patients in the Mayo Clinic study, did not have

objective signs of autonomic neuropathy, the special

master was not plainly wrong in finding that she was not

shown to be among the 50 percent of POTS patients

whose condition, according to the Mayo Clinic study, was

caused by autonomic neuropathy.3

In addition to relying on the Mayo Clinic study, Ms.

Hibbard looks for support to the reports of several of her

treating physicians who, she argues, “suspected she

suffered an autonomic neuropathy that caused her dy-

sautonomia and POTS.” The special master reviewed the

numerous medical reports in the record and found that

while two of her treating physicians concluded that Ms.

Hibbard had autonomic neuropathy, several others,

including experts on Guillain Barré Syndrome and auto-

nomic dysfunction, did not. For example, Dr. Gorson

concluded from his examination and testing that auto-

nomic neuropathy was “a possibility,” but he stated that

he was “hesitant to confirm autonomic neuropathy with-

out more objective data to support such entity.” Dr.

Gorson recommended additional testing “to confirm an

autonomic element to her disorder.” And following the

3 Dr. Chaudhry noted that a consistent pattern of

orthostatic hypotension without a corresponding rise in

heart rate is a common sign of autonomic neuropathy. He

stated that although Ms. Hibbard showed reduced blood

pressure upon standing in some instances, that syndrome

was not consistent and therefore was not a sign of auto-

nomic neuropathy. Dr. Morgan, Ms. Hibbard’s expert,

agreed that the reduction in her blood pressure observed

on several occasions was not significant.

HIBBARD v. HHS 22

recommended testing, Dr. Freeman found that it re-

mained “unclear” the “extent to which autonomic dysfunc-

tion is contributing to her symptoms.”

Other physicians likewise had doubts about auto-

nomic neuropathy as a diagnosis. Two of her treating

physicians suggested that she might have vestibular

migraines, the diagnosis that Dr. Chaudhry regarded as

most consistent with her symptoms. Another suggested

that she might have a mitochondrial disorder. A fourth

stated that he was “suspicious that some of these symp-

toms could be psychosomatic in origin, given the extensive

negative work-up.” And a fifth concluded that “the cause

of her symptoms remains unclear. I don’t see anything

pathologic on exam and her work-up in the past has been

extensive and unremarkable.” In view of the array of

different opinions among Ms. Hibbard’s examining and

treating physicians as to the cause or causes of her symp-

toms, it was not arbitrary and capricious for the special

master to conclude from the medical evidence, including

the medical records of her physicians, that “the evidence

weighs in favor of a finding that Ms. Hibbard did not have

autonomic neuropathy.”4

Finally, Ms. Hibbard invokes the testimony of the two

experts in this case. While her own expert stated that it

was his medical opinion that she had autonomic neuropa-

4 Several of the physicians’ notes on which Ms.

Hibbard relies appear to be simply repeating Dr. Novak’s

initial diagnosis of autonomic neuropathy rather than

reflecting any additional testing or independent diagnos-

tic work. Dr. Novak’s original diagnosis, moreover, ap-

pears to be based, at least in part, on his conclusion that

“Autonomic testing by Dr. Freeman showed . . . autonomic

neuropathy,” when in fact, Dr. Freeman did not conclude

from his group’s testing that Ms. Hibbard had autonomic

neuropathy.

23 HIBBARD v. HHS

thy, the respondent’s expert, Dr. Chaudhry, disagreed.

Dr. Chaudhry agreed with the report prepared by Drs.

Gibbons and Freeman that Ms. Hibbard has POTS, and

he agreed with their statement that POTS, although a

non-specific finding, “has been associated with mild or

early autonomic neuropathy.” Ms. Hibbard relies on that

statement as supporting her claim. In fact, however, that

statement merely reaffirmed that some POTS patients

have a limited form of autonomic neuropathy, a proposi-

tion that was undisputed. As Dr. Chaudhry explained at

length in his testimony, he concluded that Ms. Hibbard’s

POTS did not point to autonomic neuropathy. He based

his opinion that Ms. Hibbard did not have autonomic

neuropathy largely on the fact that the specific tests of

Ms. Hibbard’s autonomic nervous system returned normal

results. In addition, he testified that a limited form of

autonomic neuropathy of the sort that Dr. Morgan be-

lieved was present in Ms. Hibbard’s case would not ex-

plain the large number and range of symptoms that she

reported. The special master reached the same conclusion

as Dr. Chaudhry, and for the same reasons. Thus, con-

trary to Ms. Hibbard’s contention, Dr. Chaudhry’s testi-

mony does not provide any support for her claim. Instead,

his testimony constitutes substantial evidence in support

of the special master’s decision.

In sum, considering the limited nature of our statu-

tory role in reviewing factual determinations by special

masters in Vaccine Act cases, we cannot conclude that the

contrary evidence in this case is so compelling that we

must reverse the special master’s finding that Ms.

Hibbard has not shown that she suffers from autonomic

neuropathy. The special master’s finding is “based on

evidence in the record that [is] not wholly implausible,”

Cedillo, 617 F.3d at 1338, and the special master has

articulated a rational basis for his decision, Hines, 940

HIBBARD v. HHS 24

F.2d at 1528. Because, as we have noted, a finding of

autonomic neuropathy is critical to Ms. Hibbard’s theory

of causation, we hold that the special master’s finding on

that issue is fatal to Ms. Hibbard’s petition for compensa-

tion under the Vaccine Act.

AFFIRMED

United States Court of Appeals

for the Federal Circuit

__________________________

JENNIFER HIBBARD,

Petitioner-Appellant,

v.

SECRETARY OF HEALTH AND HUMAN

SERVICES,

Respondent-Appellee.

__________________________

2012-5007

__________________________

Appeal from the United States Court of Federal

Claims in case no. 07-VV-446, Judge Thomas C. Wheeler.

__________________________

O’MALLEY, Circuit Judge, dissenting.

For the reasons explained in my concurrence in

Lombardi v. Secretary of Heath & Human Services, 656

F.3d 1343, 1356 (Fed. Cir. 2011), I continue to question

whether our decision in Broekelschen v. Secretary of

Health & Human Services, 618 F.3d 1339 (Fed.Cir.2010)

represents an appropriate extension of our prior holdings.

I do not dissent here on those grounds, however, or

merely to repeat those concerns. I dissent here because

the Special Master, and now the majority, incorrectly

apply Broekelschen to this case and, in doing so, further

erode what is left of this court's precedential holding in

Althen v. Secretary of Health & Human Services, 418 F.3d

HIBBARD v. HHS 2

1274 (Fed.Cir.2005). If this court wishes to abandon the

burden shifting framework Althen describes—and thereby

increase the hurdles Vaccine Act Claimants must over-

come—it should do so expressly and en banc. Instead, we

have condemned Althen to a tortured end by continuing to

endorse Special Masters’ concerted efforts to narrow its

application. I can not endorse such a cause, particularly

on the record here.

Ms. Hibbard’s case presents what should have been a

straightforward application of Althen, where once Ms.

Hibbard put forward a prima facie showing of causation,

the burden should have shifted to the respondent to

establish an alternative cause for her injury. As ex-

plained below, that is not the methodology the Special

Master employed in finding against Ms. Hibbard on her

Vaccine Act claim and is not the methodology to which the

majority now defers, however. Putting questions of

methodology aside, moreover, I believe the Special Mas-

ter’s finding that Ms. Hibbard did not suffer from an

autonomic neuropathy to be arbitrary and capricious.

I.

In Althen, this court explained that a claimant seek-

ing compensation for an off-Table injury must show that

the “vaccination caused her malady.” 418 F.3d at 1278.

Specifically, the court set forth the following three-part

test for causation:

[The petitioner's] burden is to show by preponder-

ant evidence that the vaccination brought about

her injury by providing: (1) a medical theory caus-

ally 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 HIBBARD v. HHS

(3) a showing of a proximate temporal relation-

ship between vaccination and injury.

Id. By broadly defining what constitutes sufficient pre-

ponderant evidence of causation, this framework repre-

sents a balance between providing compensation to an

injured claimant and permitting the government an

opportunity to demonstrate that the claimant's injury is

due to factors unrelated to the vaccine. Id. Because Ms.

Hibbard established a prima facie case for causation, the

burden should have shifted to the government to identify

an alternative, more likely, cause of Ms. Hibbard’s dy-

sautonomia.

In Broekelschen, the court addressed a scenario in

which the parties contested the existence and nature of

claimant’s injury. 618 F.3d at 1343. Specifically, the

parties disputed whether Dr. Broekelschen, the peti-

tioner, suffered from transverse myelitis or anterior

spinal artery syndrome. Id. While the two different

injuries are associated with the symptoms presented by

Dr. Broekelschen, the underlying cause of each injury is

materially different, and it was undisputed that only

transverse myelitis is arguably related to the flu vaccine.

Id. at 1346. Therefore, “the question of causation turn[ed]

on which injury Dr. Broekelschen suffered . . . [and] it was

appropriate in this case for the special master to first

determine which injury was best supported by the evi-

dence presented in the record before applying the Althen

test . . . .” Id. (emphasis added). The majority here finds

similarity between Ms. Hibbard’s claim and that made in

Broekelschen and sanctions the Broekelschen approach,

claiming “it was not error for the special master to focus

first on whether she actually had the injury that she

claims was caused by the vaccine before addressing the

HIBBARD v. HHS 4

question whether the vaccine actually caused that injury

in her case.” Majority at 16.

But no such dispute exists with respect to the injury

claimed by Ms. Hibbard. The majority’s analysis, like the

Special Master’s, focuses entirely on questions of causa-

tion rather than injury. All parties—and the Special

Master and court below—agree that Ms. Hibbard suffers

from dysautonomia. They differ only with respect to the

cause of the dysautonomia. Ms. Hibbard, and her expert,

Dr. Thomas Morgan, contend that the flu vaccine caused

her to suffer postural orthostatic tachycardia syndrome

(“POTS”), a limited form of autonomic neuropathy, which

manifested itself as dysautonomia. The respondent, and

its expert, Dr. Vinay Chaudhry, argue that Ms. Hibbard

cannot prove by a preponderance of the evidence that she

suffered an autonomic neuropathy, and, therefore, can not

confirm the cause of her dysautonomia. The respondent

notes that other possible causes of dysautonomia exist,

but makes no effort to connect any of the alternative

causes to Ms. Hibbard. Specifically, Dr. Chaudhry testi-

fied that he does not know the cause of Ms. Hibbard’s

dysautonomia. Unlike the “unusual” case in Broekel-

schen, where “the exact injury and its nature—

inflammatory response or vascular event—is in dispute,

and, more importantly, the causation question turns on

the determination of the injury,” no alternative theory of

causation was presented here and no alternative injury or

diagnoses other than dysautonomia is in play. Broekel-

schen, 618 F.3d at 1349.

Even accepting it as true, the contention that Ms.

Hibbard’s autonomic neuropathy “was a necessary com-

ponent of her theory of vaccine-induced injury” does not

give license to either the Special Master, or this court, to

sidestep the inquiry that we have endorsed in Althen.

5 HIBBARD v. HHS

The majority inappropriately conflates an element within

the medical causation theory with the injury itself, and it

is exactly this focus on causation that Althen’s burden

shifting approach was designed to prevent. The danger of

permitting a Special Master to circumvent Althen is

apparent on this record. By characterizing his determina-

tion with respect to causation as a predicate factual

finding, the Special Master effectively avoided both the

appropriate burden of proof and the relevant standard of

review.

The majority is correct that Ms. Hibbard has not pre-

sented definitive confirmation that she suffered an auto-

nomic neuropathy, or that the flu vaccine caused her

dysautonomia, but that is not what Althen or the Vaccine

Act asks of a petitioner. See Althen, 418 F.3d at 1279-

1280. As Althen explains, a petitioner makes his or her

prima facie case by satisfying a three part test—namely

showing a medical theory causally connecting the vacci-

nation and the injury, a logical sequence of cause and

effect that the vaccination was the reason for the injury,

and a proximate temporal relationship between vaccina-

tion and injury—before returning the burden to the

respondent to show causation by factors unrelated to the

vaccine. Id. If the respondent then fails to meet that

burden by a preponderance of the evidence, the petitioner

has, under the Althen framework, necessarily made a

proper showing of causation. Id. No further showing by

the petitioner is necessary. Requiring that a petitioner

show actual causation by a preponderance of the evidence

not only eliminates the burden shifting mechanism con-

templated by Althen but also renders meaningless the

words “theory” and “logical sequence.” Simply put, noth-

ing in Althen—nor in the Vaccine Act itself—requires

showing actual causation by a preponderance of the

HIBBARD v. HHS 6

evidence; satisfaction of the three prongs is sufficient

absent rebuttal by the government.

It is undisputed that, on this record, the failure to

place the burden on the government to establish an

alternative cause for Ms. Hibbard’s injury was determina-

tive; the government proffered evidence of none. The

failure here to apply correctly the test set forth in Althen,

and the unwarranted extension of Broekelschen to this

very different factual scenario, is legal error requiring

reversal of the Special Master’s determination.

II.

Even accepting the majority’s decision to endorse the

Special Master’s extension of Broekelschen well beyond its

facts, I would still reverse the Special Master’s determi-

nation, finding it to be arbitrary and capricious on the

evidence presented. We review factual findings of the

Special Master with a high level of deference, but those

findings must reflect a consideration of the relevant

evidence of record, not be wholly implausible, and articu-

late a rational basis for the conclusion reached. See, e.g.,

Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328,

1338 (Fed. Cir. 2010); Hines v. Sec’y of the Dep’t of Health

& Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). I

cannot agree that the Special Master’s conclusion that

Ms. Hibbard did not suffer an autonomic neuropathy is

plausible.

For example, the record demonstrates that Ms.

Hibbard received multiple diagnoses of autonomic neu-

ropathy from her treating physicians. As the majority

recognizes, after an evaluation in 2004, neurologist Dr.

Louis Caplan concluded that Ms. Hibbard had “a postin-

fectious neuopathy with autonomic features.” Majority at

7 HIBBARD v. HHS

5. Testing by Dr. Christopher Gibbons and Dr. Roy

Freeman resulted in an abnormal result that led to a

diagnosis of POTS. Majority at 5. Specifically, the test-

ing found “evidence of an exaggerated postural tachycar-

dia . . . [which] has been associated with a mild or early

autonomic neuropathy . . . .” A neurological examination

by Dr. Russel Chin in 2005 noted these abnormal results

and the previous diagnosis of POTS and autonomic neu-

ropathy. While Dr. Chin was unable to confirm the prior

diagnosis, he did state that many of the other possible

causes for her symptoms had been ruled out. And in

2007, Dr. Peter Novak, concluded that the results of his

evaluation of Ms. Hibbard are suggestive of an autonomic

neuropathy.

The Special Master, however, rejected this record evi-

dence as inconclusive by noting that other doctors have

“refrain[ed]” from making a diagnosis of autonomic neu-

ropathy. He complains that one of the other treating

physicians only identified autonomic neuropathy as a

“possibility” and that he was “hesitant to confirm” it. And

he further relies on an evaluation, from a doctor who

performed later testing, stating that it was “unclear” the

extent to which autonomic dysfunction was contributing to

her systems. These equivocal statements do not, how-

ever, justify the conclusion that Ms. Hibbard does not

have an autonomic neuropathy, especially when there is

little indication that a conclusive diagnosis of autonomic

neuropathy is generally given. In fact, it is only Dr.

Chaudhry—and, by extension, the Special Master—who

has reached this absolute conclusion.

The so called “objective tests” similarly provide little

support for the Special Master’s determination that Ms.

Hibbard does not have an autonomic neuropathy. As the

majority notes, the Special Master relied “on the fact that

HIBBARD v. HHS 8

the various objective tests for autonomic neuropathy that

were conducted in Ms. Hibbard’s case were all negative.”

Majority at 20. But this determination misrepresents the

significance of the tests, statements made by Ms.

Hibbard’s expert, and statements made by the respon-

dent’s expert. In fact, the majority acknowledges a sen-

tence later that not all of Ms. Hibbard’s test results were

normal. Id. The Special Master ignored these abnormal

test results, because, in his words, “Dr. Morgan agreed

that Ms. Hibbard did not have any objective signs for a

neuropathy.” Dr. Morgan does not, however, make the

concessions that the Special Master attributes to him. He

testified that he agrees that the tests performed had

“mostly” normal results—excluding the abnormal re-

sults—but that statement does not support the Special

Master’s leap to “no objective signs.” Dr. Morgan did

testify that he agrees that Dr. Chaudhry’s report states

that there are no objective signs of Ms. Hibbard having a

peripheral neuropathy. But in the question and answer

immediately following that statement, Dr. Morgan clari-

fied that he believes Ms. Hibbard has a case of autonomic

neuropathy without peripheral involvement.

The Special Master, moreover, applied an unwar-

ranted significance to those results. Nowhere does Dr.

Chaudhry opine that the objective tests are conclusive for

diagnosing an autonomic neuropathy. In fact, all evi-

dence points to the fact that the tests do not reliably

disprove the existence of autonomic neuropathy, despite

the fact that they offer “objective” outputs. Dr. Chaudhry

admitted that there is a possibility Ms. Hibbard has mild

neuropathy, failed to provide any alternative diagnosis for

Ms. Hibbard’s POTS or dysautonomia, and testified that

he actually had ruled out many of the alternative causes

for Ms. Hibbard’s POTS. Dr. Morgan’s testimony on this

topic is enlightening:

9 HIBBARD v. HHS

Q: And, Doctor, having employed that method, you

indicated are there other diseases associated with

it, in Ms. Hibbard's case were there any other

causes found for her dysautonomia?

A: There were not.

***

Q: What tests did they do in May to rule out dy-

sautonomia?

A: Tests don't make the diagnosis. All right?

Tests help support a diagnosis. If it was that easy,

you don't need doctors, just plug it into the com-

puter, spit it out and you've got your diagnosis. So,

there were no tests and they wouldn't necessarily

drive the diagnosis, but, more importantly, there's

probably no need to do those tests.

A169; A246.

The error in over-reliance on these objective tests is

amply seen in the Special Master’s—and the majority’s—

treatment of the Mayo Clinic study introduced by Ms.

Hibbard. In that study, researchers concluded that a

neuropathic basis existed for at least half of the cases of

POTS they examined, which supported their initial postu-

late that POTS is a limited autonomic neuropathy. Here,

all parties agree that Ms. Hibbard has POTS. They

disagree only as to the significance of this finding with

respect to a conclusion of autonomic neuropathy. Ms.

Hibbard contends that the Mayo Clinic study shows that

her POTS is indicative of an autonomic neuropathy. The

Special Master, in contrast, agreed with the respondent’s

view that Ms. Hibbard’s predominantly normal test

HIBBARD v. HHS 10

results support a conclusion that she is not in the ap-

proximately 50 percent of all POTS patients that have a

limited form of autonomic neuropathy.

The majority’s acceptance of the respondent’s position

suffers from the same flaw as the Special Master’s before

it. Ms. Hibbard does not dispute that causes other than

neuropathy exist for POTS, but, as Dr. Chaudhry testi-

fied, no other cause for Ms. Hibbard’s POTS was identi-

fied and many of the possible alternative causes were

expressly ruled out. As such, the likelihood that Ms.

Hibbard’s POTS was caused by a neuropathy is actually

significantly greater than the 50 percent likelihood trum-

peted by the majority. More importantly, the lack of

abnormal test results provides almost no support for the

conclusion that Ms. Hibbard is not part of the 50 percent

of people whose autonomic neuropathy caused their

POTS. In the Mayo Clinic study, 90.8 percent of the

participants exhibited predominantly normal results in

response to tests similar to the ones performed on Ms.

Hibbard. Therefore, even assuming all of the patients

that had abnormal results suffered from autonomic

neuropathy, over 80 percent of the participants in the

study identified as having POTS and autonomic neuropa-

thy would have had to exhibit predominantly normal

results to the “objective” tests relied on so heavily by the

special master.

I agree that a Special Master’s factual findings are ac-

corded deference, but in light of the great evidence to the

contrary, I must conclude that the Special Master’s de-

termination that Ms. Hibbard did not suffer an autonomic

neuropathy was arbitrary and capricious.

11 HIBBARD v. HHS

III.

Based on the record before us, I think it clear that Ms.

Hibbard has put forward a prima facie case under Althen

that the administered flu vaccine caused her dysautono-

mia. The Special Master characterized Dr. Morgan’s

medical theory as “poorly supported,” but the respondent

appears to present no real challenge to Ms. Hibbard’s

satisfaction of the first Althen prong. Rather, the respon-

dent focused on whether Ms. Hibbard affirmatively estab-

lished that she suffered from one of the links in the causal

chain leading to her injury. Regardless of the respon-

dent’s attack on the adequacy of the evidence of auto-

nomic neuropathy, the respondent cannot dispute that the

evidence establishes a logical sequence of cause and

effect. I therefore see no legitimate dispute as to Ms.

Hibbard’s satisfaction of the second Althen prong. Fi-

nally, as the majority notes, the respondent expressly

conceded that Ms. Hibbard’s claim satisfies the temporal

prong. Majority at 11. Having presented a prima facie

case of causation, the burden, in accordance with Althen,

appropriately shifts to the respondent to demonstrate a

likely alternative cause for Ms. Hibbard’s injury.1 As Ms.

Hibbard contends, the respondent failed to put forward

any alternative cause, let alone a likely one. Dr.

Chaudhry’s testimony fails to back any alternative theory

that would explain Ms. Hibbard’s injury. As such, rever-

sal of the determination of the Special Master and entry

of judgment for the petitioner is appropriate.

1 If the majority and the Special Master were cor-

rect that, in addition to the Althen showing, a Vaccine Act

claimant must also separately establish each link in the

causal chain by a preponderance of the evidence, there

would be no burden left to shift back to the government.

HIBBARD v. HHS 12

Separately, and in addition, I would find that the Spe-

cial Master erred in determining that Ms. Hibbard did not

establish that she suffered an autonomic neuropathy by a

preponderance of the evidence. This error standing alone

warrants reversal.