Broekelschen v. Secretary of Health & Human Services

United States Court of Appeals

for the Federal Circuit

__________________________

PETER BROEKELSCHEN, M.D.,

Petitioner-Appellant

v.

SECRETARY OF HEALTH AND HUMAN

SERVICES,

Respondent-Appellee.

__________________________

2009-5132

__________________________

Appeal from the United States Court of Federal

Claims in case no. 07-VV-137, Judge George W. Miller.

____________________

Decided: September 10, 2010

____________________

LISA A. ROQUEMORE, Broker & Associates, PC, of Ir-

vine, California, argued for petitioner-appellant.

VORIS E. JOHNSON, JR., 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.

__________________________

BROEKELSCHEN v. HHS 2

Before GAJARSA, MAYER, and PLAGER, Circuit Judges.

Opinion for the court filed by Circuit Judge GAJARSA.

Dissenting Opinion filed by Circuit Judge MAYER.

GAJARSA, Circuit Judge.

Peter Broekelschen, M.D., appeals the decision of the

United States Court of Federal Claims affirming a special

master’s decision denying Dr. Broekelschen’s petition for

compensation under the National Childhood Vaccine

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

-34 (2006). The special master concluded that Dr. Broek-

elschen did not prove by a preponderance of the evidence

that the flu vaccine caused his injury. See Broekelschen v.

Sec’y of Health & Human Servs., 89 Fed. Cl. 336 (2009).

Because the Court of Federal Claims correctly concluded

that the special master’s decision was not arbitrary,

capricious, an abuse of discretion, or otherwise not in

accordance with law, we affirm.

BACKGROUND

I.

A petitioner seeking compensation under the Vaccine

Act must prove by a preponderance of the evidence that

the injury or death at issue was caused by a vaccine. 42

U.S.C. §§ 300aa-11(c)(1), -13(a)(1). A petitioner can show

causation under the Vaccine Act in one of two ways.

Either the petitioner can prove causation by showing that

she sustained an injury in association with a vaccine

listed in the Vaccine Injury Table (“Table injury”). Id.

§ 300aa-11(c)(1)(C)(i). In such a case, causation is pre-

sumed. Andreu v. Sec’y of Health & Human Servs., 569

F.3d 1367, 1374 (Fed. Cir. 2009). Or, if the complained-of

injury is not listed in the Vaccine Injury Table (“off-Table

injury”), the petitioner may seek compensation by proving

3 BROEKELSCHEN v. HHS

causation in fact. Moberly v. Sec’y of Health & Human

Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); see also 42

U.S.C. § 300aa-11(c)(1)(C)(ii). Once the petitioner has

demonstrated causation, she is entitled to compensation

unless the government can show by a preponderance of

the evidence that the injury is due to factors unrelated to

the vaccine. Doe v. Sec’y of Health & Human Servs., 601

F.3d 1349, 1351 (Fed. Cir. 2010); see also 42 U.S.C.

§ 300aa-13(a)(1)(B).

II.

On October 28, 2005, Dr. Broekelschen received a flu

vaccine. At the time he received the flu vaccine, Dr.

Broekelschen was sixty-three years old and was in excel-

lent health. He had an active medical practice in gastro-

enterology working about sixty hours a week. In addition,

Dr. Broekelschen enjoyed an active lifestyle spending

most weekends jogging, bicycling, swimming, kayaking, or

skiing.

On December 16, 2005, while at work, Dr. Broekel-

schen developed crushing pain in his chest that spread to

his arms, fingers, neck, and around his left scapula. Dr.

Broekelschen was transported by ambulance to Hoag

Memorial Hospital Presbyterian and admitted that same

day. Doctors first performed multiple electrocardiograms

(“EKGs”) to test Dr. Broekelschen’s heart activity, which

appeared normal, thus ruling out a heart attack. Doctors

then performed Magnetic Resonance Imaging (“MRI”)

revealing degenerative changes in the cervical spine.

Additional MRIs revealed two lesions, one in the cervical

spine (C2-C3 level) and one in the thoracic spine (T2

level). Doctors also performed an angiogram revealing an

occlusion of the anterior spinal artery at the C2-C3 level.

While Dr. Broekelschen was hospitalized, he required an

emergency bladder catheterization due to paralysis in his

BROEKELSCHEN v. HHS 4

bladder and bowels. Doctors took a cerebrospinal fluid

sample that revealed normal levels of Immunoglobulin G

(“IgG”), one white blood cell, and an elevated protein

count. According to Dr. Jacob P. Verghese, the doctor who

discharged Dr. Broekelschen, Dr. Broekelschen’s proprio-

ception was unaffected. Proprioception is the ability to

sense the position, location, orientation, and movement of

one’s body and its parts. But Dr. Broekelschen testified

that a neurologist visited him while he was hospitalized

and concluded that Dr. Broekelschen’s proprioception was

abnormal.

While Dr. Broekelschen was hospitalized, the differ-

ential diagnoses included anterior spinal artery syndrome

or transverse myelitis, possibly due to the flu vaccine.

Anterior spinal artery syndrome is a vascular event

caused by an occlusion or blockage in the anterior spinal

artery, reducing blood flow, that disrupts neurological

activity only on the anterior side of the spinal column.

Transverse myelitis is a neurological disorder caused by

an abnormal immune response resulting in inflammation

across both sides of one level of the spinal cord that inter-

rupts communications between the nerves in the spinal

cord and the rest of the body. Ultimately, Dr. Verghese

concluded in a discharge summary that Dr. Broekelschen

suffered from cervical myelopathy, etiology unknown.

Cervical myelopathy is a general term referring to dys-

function of the spinal cord caused by one of many diseases

including anterior spinal artery syndrome and transverse

myelitis.

More than three months after Dr. Broekelschen was

hospitalized, he was examined by various doctors in an

effort to determine the proper diagnosis. Dr. Stanley

vanden Noort, a neurologist, and Dr. John C. Storch, Dr.

Broekelschen’s primary care physician, both examined Dr.

Broekelschen and concluded that he suffered from trans-

5 BROEKELSCHEN v. HHS

verse myelitis secondary to the flu vaccine. However, Dr.

Storch wrote “there is no test available to prove this” and

his conclusion was made “in the absence of another work-

ing diagnosis.” J.A. 119. Dr. vanden Noort observed that

Dr. Broekelschen’s proprioception was affected in his left

foot and simply stated that “[o]ur neuroradiologists con-

cur with the report of transverse myelitis.” J.A. 117. Dr.

vanden Noort, however, concluded that “[i]t is not neces-

sary to pursue alternative diagnoses because [Dr. Broek-

elschen] is improving slowly.” Id.

Despite Dr. vanden Noort and Dr. Storch’s conclu-

sions, Dr. Broekelschen presented symptoms that are

characteristic of both anterior spinal artery syndrome, a

vascular condition, and transverse myelitis, an inflamma-

tory response. Both injuries can cause severe neck or

lower back pain and paralysis of the bladder, bowels, and

extremities. One distinguishing symptom, however, is

that proprioception is affected in transverse myelitis, but

not in anterior spinal artery syndrome. In addition, if a

patient suffers from transverse myelitis, doctors would

typically observe elevated levels of white blood cells and

IgG in the cerebrospinal fluid because transverse myelitis

is often caused by an immune response. On the other

hand, if a patient suffered from anterior spinal artery

syndrome, an angiogram, which is a visualization of blood

flow, would evidence an occlusion in the anterior spinal

artery.

III.

Dr. Broekelschen filed a petition in the Court of Fed-

eral Claims seeking compensation under the Vaccine Act

alleging that the flu vaccine caused him to suffer trans-

verse myelitis. See Broekelschen v. Sec’y of Health &

Human Servs., No. 07-137V, 2009 U.S. Claims LEXIS 137

(Fed. Cl. Feb. 4, 2009) (special master’s published decision

BROEKELSCHEN v. HHS 6

denying entitlement). The case was assigned to a special

master from the Court of Federal Claims. Because trans-

verse myelitis is an off-Table injury, Dr. Broekelschen

was required to prove causation in fact. See 42 U.S.C.

§ 300aa-11(c)(1)(C)(ii).

Both parties retained well-qualified experts, who

submitted reports and testified at a hearing held by the

special master regarding whether the flu vaccine caused

Dr. Broekelschen’s injury. Dr. Lawrence Steinman, Dr.

Broekelschen’s expert, is a Board Certified Neurologist, a

Professor of Neurology and Pediatrics, and chair of the

Program in Immunology at Stanford University. He has

over thirty years of medical experience in neurology and

has dealt with transverse myelitis as a result of vaccina-

tions several times a year as either a treating physician or

in departmental conferences. Dr. Steinman has served on

expert and advisory panels relating to vaccination mat-

ters as well as received various awards for research on the

nervous system. He has also authored over 300 articles

relating to how the immune system attacks the nervous

system with about twenty articles directly dealing with

vaccines. Dr. Steinman opined that the flu vaccine caused

Dr. Broekelschen to suffer transverse myelitis.

Dr. Benjamin Greenberg, the government’s expert,

disagreed and opined that Dr. Broekelschen suffered from

anterior spinal artery syndrome, which was not caused by

the flu vaccine. At the time of the hearing, Dr. Greenberg

was an assistant professor in the Department of Neurol-

ogy at Johns Hopkins School of Medicine. Dr. Greenberg

was also the co-director of the Johns Hopkins Transverse

Myelitis Center, the only center in the world dedicated to

transverse myelitis. As of July 2007, the Johns Hopkins

Transverse Myelitis Center had seen over 1200 patients

with spinal cord disease. Also, the Transverse Myelitis

Center has done extensive research on the diagnosis,

7 BROEKELSCHEN v. HHS

treatment, and long-term care of patients with transverse

myelitis. As a result of his position, Dr. Greenberg

worked with patients suffering from transverse myelitis

on a daily basis.

On February 4, 2009, the special master published a

detailed explanation for his decision denying Dr. Broekel-

schen entitlement under the Vaccine Act. Broekelschen,

2009 U.S. Claims LEXIS 137, at *1. Because there was a

dispute between the parties regarding Dr. Broekelschen’s

alleged injury, the special master considered as a primary

matter which injury, transverse myelitis or anterior

spinal artery syndrome, was best supported by the record.

Id. at *11. The special master conducted a thorough

analysis of all the tests performed on Dr. Broekelschen,

opinions of treating physicians, records after discharge,

and the conflicting opinions of the testifying experts. See

id. at *18–57. The special master found that “[f]or virtu-

ally every point in favor of one diagnosis, there is a point

in favor of the other diagnosis.” Id. at *45. Thus, the

special master considered each piece of evidence and

explained why it supported a finding of transverse mye-

litis or anterior spinal artery syndrome.

The special master also considered the relative weight

of the testifying experts. The special master found Dr.

Greenberg, the government’s expert, to be more persua-

sive. Id. at *49–50. He based his decision in large part on

Dr. Greenberg’s specialization while working at the Johns

Hopkins Transverse Myelitis Center, the only center in

the world devoted to transverse myelitis. Id. In addition,

Dr. Greenberg’s report and testimony incorporated all of

the evidence, whereas Dr. Steinman disregarded an

important piece of evidence, the angiogram, which showed

an occlusion in the anterior spinal artery. Id. at *56. The

special master also indicated that Dr. Greenberg’s “de-

meanor suggested that he was attempting to provide the

BROEKELSCHEN v. HHS 8

basis for his opinion as forthrightly as possible.” Id. at

*36. The special master concluded that “the weight of the

entire record—including (but not limited to) the an-

giogram, the MRIs, the finding regarding proprioception,

the statements of treating doctors, and the testimony of

Dr. Broekelschen, Dr. Steinman and Dr. Greenberg—

indicates that Dr. Broekelschen suffered anterior spinal

artery syndrome.” Id. at *56.

After the special master found that anterior spinal ar-

tery syndrome was the injury best supported by the

evidence, the special master considered whether Dr.

Broekelschen had shown by a preponderance of the evi-

dence that the flu vaccine had actually caused his anterior

spinal artery syndrome. Id. at *57–65. The special

master found that Dr. Broekelschen had not shown by

preponderant evidence “a medical theory causally con-

necting the vaccination and [anterior spinal artery syn-

drome],” Althen v. Sec’y of Health & Human Servs., 418

F.3d 1274, 1278 (Fed. Cir. 2005), and therefore Dr. Broek-

elschen had not shown by a preponderance of the evidence

that the flu vaccine caused his injury. Broekelschen, 2009

U.S. Claims LEXIS 137, at *65–66.

IV.

Dr. Broekelschen sought review of the special mas-

ter’s decision in the Court of Federal Claims. See Broekel-

schen, 89 Fed. Cl. at 336. The Court of Federal Claims

affirmed the special master’s decision, finding that the

special master properly considered the entire record. Id.

at 346. Contrary to Dr. Broekelschen’s argument, the

court found that the experts’ demeanor was only “one

factor among many,” id., and that the special master’s

credibility determination of the experts was “‘virtually

unchallengeable on appeal,’” id. at 345 (quoting Lampe v.

9 BROEKELSCHEN v. HHS

Sec’y of Health & Human Servs., 219 F.3d 1357, 1362

(Fed. Cir. 2000)).

Dr. Broekelschen appeals the decision of the Court of

Federal Claims. We have jurisdiction pursuant to 42

U.S.C. § 300aa-12(f).

DISCUSSION

We review an appeal from the Court of Federal

Claims in a Vaccine Act case de novo, applying the same

standard of review as the Court of Federal Claims applied

to its review of the special master’s decision. Andreu, 569

F.3d at 1373. We owe no deference to the trial court or

special master on questions of law. Id. We uphold the

special master’s findings of fact unless they are arbitrary

or capricious. Capizzano v. Sec’y of Health & Human

Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006). “Thus,

although we are reviewing as a matter of law the decision

of the Court of Federal Claims under a non-deferential

standard, we are in effect reviewing the decision of the

special master under the deferential and capricious

standard on factual issues.” Lampe, 219 F.3d at 1369.

I.

When a petitioner has suffered an off-Table injury, as

is the case here, this court has established the following

test for showing causation in fact under the Vaccine Act:

[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) a showing of a proximate temporal relationship

between vaccination and injury.

BROEKELSCHEN v. HHS 10

Althen, 418 F.3d at 1278. Because causation is relative to

the injury, a petitioner must provide a reputable medical

or scientific explanation that pertains specifically to the

petitioner’s case, although the explanation need only be

“legally probable, not medically or scientifically certain.”

Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543,

548-49 (Fed. Cir. 1994). “[T]he function of a special

master is not to ‘diagnose’ vaccine-related injuries, but

instead 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.’” Andreu, 569 F.3d at

1382 (quoting Knudsen, 35 F.3d at 549).

Dr. Broekelschen argues that the special master erred

by not first determining whether Dr. Broekelschen estab-

lished a prima facie case that the vaccine caused the

alleged transverse myelitis injury before determining that

Dr. Broekelschen suffered from anterior spinal artery

syndrome, an alternate cause unrelated to the vaccine.

The petitioner makes an argument by analogy to the

statutory scheme provided by the Vaccine Act where a

petitioner is entitled to recover once she has shown by a

preponderance of the evidence that the vaccine caused her

injury, “unless the [government] shows, also by a prepon-

derance of the evidence, that the injury was in fact caused

by factors unrelated to the vaccine.’” Walther v. Sec’y of

Health & Human Servs., 485 F.3d 1146, 1151 (Fed. Cir.

2007) (quoting Whitecotton v. Sec’y of Health & Human

Servs., 17 F.3d 374, 376 (Fed. Cir. 1994), rev’d on other

grounds sub nom., Shalala v. Whitecotton, 514 U.S. 268

(1995)). But the instant action is atypical because the

injury itself is in dispute, the proposed injuries differ

significantly in their pathology, and the question of causa-

tion turns on which injury Dr. Broekelschen suffered.

11 BROEKELSCHEN v. HHS

Therefore, it was appropriate in this case for the special

master to first determine which injury was best supported

by the evidence presented in the record before applying

the Althen test so that the special master could subse-

quently determine causation relative to the injury.

The Act creates a cause of action for persons suffering

a “vaccine-related injury,” see 42 U.S.C. § 300aa-11(c), and

identifies the injuries commonly associated with each

vaccine in the Vaccine Injury Table. See 42 U.S.C. §

300aa-14; 42 C.F.R. § 100.3(a). An off-Table petitioner,

who does not benefit from a presumption of causation,

must specify his vaccine-related injury and shoulder the

burden of proof on causation. Id. Also, a careful reading

of Althen, shows that each prong of the Althen test is

decided relative to the injury: (1) medical theory connect-

ing the vaccination to the injury; (2) cause and effect

showing the vaccination was the reason for the injury;

and (3) proximate temporal relationship between the

vaccination and the injury. See Althen, 418 F.3d at 1278;

Doe, 601 F.3d at 1351. Thus, identifying the injury is a

prerequisite to the analysis.

Moreover, while the two conditions—transverse mye-

litis and anterior spinal artery syndrome—have overlap-

ping symptoms, their underlying causes or etiology are

completely different. Cf. Andreu, 569 F.3d at 1378, 1381

(noting that an exact diagnosis was not required to de-

termine whether the DPT vaccine caused the injury

because while the parties disputed whether the petitioner

suffered a febrile or afebrile seizure, both parties agreed

that “whatever caused [the petitioner’s] first seizure led to

his subsequent seizure disorder”); Kelley v. Sec’y of Health

& Human Servs., 68 Fed. Cl. 84, 100–01 (2005) (finding

that the petitioner was not required to categorize his

injury where the two possible diagnoses were “variants of

the same disorder, as their pathologic features might

BROEKELSCHEN v. HHS 12

suggest”). Transverse myelitis is an inflammatory event

caused by an immune response, whereas anterior spinal

artery syndrome is a vascular event caused by a blockage.

Dr. Broekelschen presented with symptoms common to

both transverse myelitis and anterior spinal artery syn-

drome, and the parties dispute which disease Dr. Broekel-

schen suffered. This is unlike Andreu, where the parties

agreed that the petitioner suffered from a seizure disor-

der, see 569 F.3d at 1378, 1381, or Kelley, where the

competing diagnoses were variants of the same disorder,

68 Fed. Cl. at 100–01. Here, nearly all of the evidence on

causation was dependent on the diagnosis of Dr. Broekel-

schen’s injury. Therefore, it was appropriate for the

special master to first find which of Dr. Broekelschen’s

diagnoses was best supported by the evidence presented

in the record before applying the Althen test so that the

special master could subsequently determine causation

relative to the injury. Accordingly, we review each find-

ing in turn.

II.

The special master’s opinion reveals a thorough and

careful evaluation of all the evidence to ascertain which

injury is best supported by the record. See Broekelschen,

89 Fed. Cl. at 341—46. “He divided the evidence into four

categories: tests; clinical symptoms, including propriocep-

tion; opinions of treating doctors; and opinions of testify-

ing experts.” Id. at 341. He found that certain evidence,

such as the medical records and doctors’ notes, were not

as persuasive as other evidence because the treating

doctors were “not consistent in their diagnoses.” Broekel-

schen, 2009 U.S. Claims LEXIS 137, at *43. Further-

more, the special master noted that the doctors in their

post-hospitalization notes did “not provide any reasoning

for their statements.” Id. at *31. Rather, the special

master found the discharge summary written by Dr.

13 BROEKELSCHEN v. HHS

Verghese more persuasive because Dr. Verghese was very

familiar with Dr. Broekelschen’s experience while in the

hospital and was able to consider all of the medical re-

cords. Id. at *28–30, *32; see also Capizzano, 440 F.3d at

1326 (“[T]reating physicians are likely to be in the best

position to determine whether ‘a logical sequence of cause

and effect shows that the vaccination was the reason for

the injury.’” (quoting Althen, 418 F.3d at 1280)). Dr.

Verghese, in a detailed discharge summary, stated that

the “diagnosis has not been clearly established” and the

etiology was unknown. J.A. 123-24. He also summarized

all of the medical records and concluded that Dr. Broekel-

schen suffered from myelopathy—a general term encom-

passing both anterior spinal artery syndrome and

transverse myelitis. The special master reasoned that

because Dr. Verghese wrote that a diagnosis “has not

been clearly established” Dr. Verghese intended to leave

the question open.

Because the medical evidence was not definitive, the

special master relied heavily on expert medical testimony.

Broekelschen, 2009 U.S. Claims LEXIS 137, at *45, *56.

Expert medical testimony is often very important in

Vaccine Act cases based on off-Table injuries requiring

proof of actual causation. See Lampe, 219 F.3d at 1361

(“As is often true in Vaccine Act cases based on a theory of

actual causation, the expert medical testimony was im-

portant in this case.”). The special master’s decision often

times is based on the credibility of the experts and the

relative persuasiveness of their competing theories. Id. at

1362. As such, the special master’s credibility findings

“are virtually unchallengeable on appeal.” Id. However,

a special master cannot “cloak the application of an

erroneous legal standard in the guise of a credibility

determination, and thereby shield it from appellate

review.” Andreu, 569 F.3d 1379.

BROEKELSCHEN v. HHS 14

The special master recognized that both experts were

well-qualified, but found Dr. Greenberg’s testimony to be

more persuasive for three reasons. First, the special

master noted Dr. Greenberg’s work with patients suffer-

ing from transverse myelitis on a daily basis as the co-

director of the Johns Hopkins Transverse Myelitis Center,

the only center dedicated to transverse myelitis in the

world. Id. at *34–35. Second, the special master found

that Dr. Greenberg’s demeanor was more persuasive as

he was more forthright and independent in his responses.

Id. at *36. Lastly, Dr. Greenberg’s theory incorporated all

of the evidence, whereas Dr. Steinman largely excluded

one of the most important pieces of evidence, the an-

giogram. Id. at *56.

Dr. Broekelschen contends that the special master

improperly used the “guise of a credibility determination”

to exclude evidence that could support a finding of trans-

verse myelitis such as the presentation of two lesions,

abnormal proprioception post-hospitalization, and the

reports and notes of doctors. Dr. Broekelschen places

particular significance on the presence of two lesions and

states that Dr. Greenberg conceded that the finding of a

second lesion “is totally inconsistent with a vascular

event.” Petitioner’s Brief at 47. Dr. Broekelschen, how-

ever, contradicts his own expert and mischaracterizes Dr.

Greenberg’s testimony. Dr. Steinman testified that

multiple lesions “can happen” in a vascular event, albeit

“far less likely.” Dr. Greenberg testified that the presence

of multiple lesions was as likely as “a hole-in-one on a par

5,” 1 but he went on to say, “But is it possible? Absolutely

1 Indeed a hole-in-one on a par 5 is very rare. Gen-

erally, holes-in-one are seen on a par 3, which is known as

an eagle. In 2001, Andrew Magee hit the only hole-in-one

on a par 4—known as an albatross—on the PGA tour. A

hole-in-one on a par 5—known as a condor—has only

15 BROEKELSCHEN v. HHS

it’s possible.” J.A. 837–38 (emphasis added). Dr. Broek-

elschen focuses heavily on Dr. Greenberg’s first statement

and ignores his complete testimony that multiple block-

ages are “absolutely” possible. See id. Also, Dr. Broekel-

schen points to the abnormal proprioception to support a

finding of transverse myelitis. Yet there is no medical

record that Dr. Broekelschen’s proprioception was im-

paired while he was hospitalized; in fact, the discharge

summary states that his proprioception was normal.

“[R]eversible error is ‘extremely difficult to demonstrate’ if

the special master ‘has considered the relevant evidence

of record, drawn plausible inferences and articulated a

rational basis for the decision.’” Hines v. Sec’y of Health

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

Ironically, it is the petitioner that seems to advocate

only reviewing the evidence pertaining to transverse

myelitis and not the totality of the evidence presented on

Dr. Broekelschen’s condition. While Dr. Steinman em-

phasized that the MRIs indicating two lesions is inconsis-

tent with a vascular event, he essentially ignored the

angiogram showing an occlusion in the anterior spinal

artery, which is highly suggestive of anterior spinal artery

syndrome. Nor did Dr. Steinman try to reconcile the MRI

with the angiogram. On the contrary, the special master

found that Dr. Greenberg candidly acknowledged the

rarity of the double lesions but persuasively explained

why Dr. Broekelschen’s angiogram results showing a

blockage in a large artery was supportive evidence of an

underlying mechanism that is vascular in nature. He

testified:

occurred four times of record and never during a profes-

sional tournament. The ‘Condor’—Four Under Par for a Hole,

http://www.golftoday.co.uk/golf_a_z/articles/condor.html (last visited Sep.

7, 2010).

BROEKELSCHEN v. HHS 16

[E]ven when I had a patient who I would bet the

farm had a vascular event in the spinal cord, it’s

actually rare for me to see the smoking gun. See-

ing an abnormal spinal angiogram that matches

with the patient’s presentation, the patient’s MRI,

what the patient is experiencing is, again, a rarity

among rarities. . . .That is a true abnormality that

has to be taken seriously. And in the context of

somebody who has an acute myelopathy, . . .

where we did not have evidence of inflammation,

then we would have actually stopped there and we

would have said that we are most concerned about

vascular events. That’s how profound the evidence

is. . . . If there was only a lesion at the cervical

cord and proprioception was intact and we had

that angiogram, we probably wouldn’t be in this

room today. I think the angiogram findings are so

profound that nobody would have considered mye-

litis ever again.

Broekelschen, 2009 U.S. Claims LEXIS 137, at *38–39.

Also, the spinal tap showed no increase in white blood

cells or IgG, which is highly probative of a finding that Dr.

Broekelschen did not suffer from immune-mediated

transverse myelitis. Dr. Verghese concluded that the

absence of inflammation “would be against [the injury]

being due to a myelitis.” J.A. 123. Although the hospital

reports mention transverse myelitis, they also mention

ischemia, which is a vascular event encompassing ante-

rior spinal artery syndrome. The special master was

presented with all the evidence and after a thorough

review, he found that the evidence did not make it more

likely than not that Dr. Broekelschen suffered from

transverse myelitis. Id. at *36.

Considering all of the evidence, including medical re-

cords, tests, and reports, as well as the experts’ opinions,

17 BROEKELSCHEN v. HHS

the special master did not require certainty or direct

evidence, but rather weighed the evidence as the trier of

fact and found that it was more likely that Dr. Broekel-

schen suffered anterior spinal artery syndrome than

transverse myelitis. This court does not “reweigh the

factual evidence, or [] assess whether the special master

correctly evaluated the evidence. And of course we do not

examine the probative value of the evidence or the credi-

bility of the witnesses. These are all matters within the

purview of the fact finder.” Munn v. Sec’y of Health &

Human Servs., 970 F.2d 863, 871 (Fed. Cir. 1992). Thus,

the special master’s determination was not “arbitrary,

capricious, an abuse of discretion, or otherwise not in

accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B);

Hines, 940 F.2d at 1524.

III.

The dissent criticizes the special master’s decision on

two grounds. First, the dissent characterizes the special

master’s approach of first determining the injury before

applying the Althen test as per se reversible error. Dis-

senting Op. at 3. By ignoring the atypical nature of this

case, however, the dissent improperly forces this case to

align with our Althen precedent. In most cases the injury

is not disputed but this case is unusual in that 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.

The Vaccine Act creates a cause of action for persons

suffering a “vaccine-related injury.” See 42 U.S.C. §

300aa-11(a). With regard to the “vaccine-related injury,”

a off-Table petitioner must allege that he “sustained, or

had significantly aggravated, any illness, disability,

injury, or condition not set forth in the Vaccine Injury

Table but which was caused by a Vaccine referred to in

BROEKELSCHEN v. HHS 18

subparagraph (a) . . . . “ Id. § 300aa-11(c)(1)(C)(ii)(I). This

is the same definition quoted by the dissent but it does

not support its argument that proof of an “illness, condi-

tion, or disability” is something less than proof of an

“injury” under the Vaccine Act. Dissenting Op. at 3.

Medical recognition of the injury claimed is critical and by

definition a “vaccine-related injury,” i.e., illness, disabil-

ity, injury or condition, has to be more than just a symp-

tom or manifestation of an unknown injury. Thus, it was

appropriate for the special master to initially determine

which injury Dr. Broekelschen suffered before applying

the Althen test.

The dissent also criticizes the special master’s finding

that the government’s expert had a more persuasive

demeanor. Dissenting Op. at 7. In general, when two

expert witnesses, both highly qualified, dispute an issue

of medical fact with supporting and contradictory evi-

dence, it is immaterial whether one witness makes a

better appearance on the stand. See Andreu, 569 F.3d at

1379; cf. Moberly, 592 F.3d at 1325—26 (stating that in

cases where there is little supporting evidence for an

expert’s opinion, the special master’s “[a]ssessments as to

the reliability of expert testimony often turn on credibility

determinations”). Though the special master may have

improperly considered Dr. Greenberg’s demeanor, it was

not the only factor, or even the most important factor, in

the special master’s analysis. To the contrary, the special

master articulated a number of factors why Dr. Green-

berg’s medical testimony was better supported by sound

medical explanation, including the fact that Dr. Green-

berg’s testimony candidly and forthrightly incorporated

all of the evidence whereas Dr. Steinman largely excluded

an important piece of adverse evidence. Thus, even if the

special master’s consideration of Dr. Greenberg’s “de-

meanor” was error, it would rise at most to the level of

19 BROEKELSCHEN v. HHS

harmless error. Hines, 940 F.2d at 1526 (finding that it

was harmless error for the special master to take judicial

notice of a medical textbook’s statement regarding the

incubation period of measles, even if unfair to the peti-

tioner, because “the special master’s decision was based

on a number of factors and [petitioner had] not shown

that reliance on the . . . textbook was likely critical to the

result”).

IV.

Next, for Dr. Broekelschen to recover under the Vac-

cine Act, he is required to prove by a preponderance of the

evidence that the flu vaccine caused his anterior spinal

artery syndrome, an off-Table injury. As explained above,

the Althen test requires that Dr. Broekelschen prove by a

preponderance of the evidence: “(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.” Althen, 418 F.3d at 1278.

The special master found that Dr. Broekelschen did

not meet his burden of proving by a preponderance of the

evidence a medical theory causally connecting the flu

vaccine to anterior spinal artery syndrome. Broekelschen,

2009 U.S. Claims LEXIS 137, at *65; Broekelschen, 89

Fed. Cl. at 346. Dr. Broekelschen does not challenge this

finding; rather, he argues only that anterior spinal artery

syndrome is a cause unrelated to the vaccine that the

special master should not have considered until Dr.

Broekelschen established his prima facie case with the

alleged transverse myelitis injury. As we explained

above, the special master properly considered the gov-

ernment’s alternative evidence on injury prior to deter-

mining causation. See 42 U.S.C. § 300aa-13(a)(1); Doe,

BROEKELSCHEN v. HHS 20

601 F.3d at 1356-58 (stating that the government can

provide and the special master can consider evidence of

“factors unrelated” in determining whether the petitioner

established a prima facie case). Thus, the remaining

question is whether, contrary to the special master’s

finding, Dr. Broekelschen provided proof by a preponder-

ance of the evidence of a medical theory causally connect-

ing the flu to anterior spinal artery syndrome.

The majority of the evidence and testimony presented

by Dr. Broekelschen was directed toward proving the flu

vaccine caused transverse myelitis. Dr. Steinman pre-

sented the same medical theory, molecular mimicry, for

both anterior spinal artery syndrome and transverse

myelitis. Dr. Greenberg pointed out, however, that the

evidence relied upon for connecting the molecular mim-

icry theory to the flu vaccine—a literature review based

on two papers from the early 1950s, which in turn consid-

ered vaccine cases between 1929 and 1952—was quite

weak. Furthermore, there was little said by either party

during the hearing and post-trial briefs regarding

whether the flu vaccine can cause anterior spinal artery

syndrome. “Althen makes clear that a claimant’s theory

of causation must be supported by a ‘reputable medical or

scientific explanation.’” Andreu, 569 F.3d at 1379 (quot-

ing Althen, 418 F.3d at 1278). The special master found

that due to the weak medical evidence presented, Dr.

Broekelschen had not provided a “reliable medical or

scientific explanation” sufficient to prove by a preponder-

ance of the evidence a medical theory linking the flu

vaccine to anterior spinal artery syndrome. See Knudsen,

35 F.3d at 548. We find that this conclusion was not

arbitrary or capricious.

For the foregoing reasons, we find that the special

master’s determination was not arbitrary, capricious, an

21 BROEKELSCHEN v. HHS

abuse of discretion, or otherwise not in accordance with

law. We therefore affirm.

AFFIRMED

No costs.

United States Court of Appeals

for the Federal Circuit

__________________________

PETER BROEKELSCHEN, M.D.,

Petitioner-Appellant,

v.

SECRETARY OF HEALTH AND HUMAN

SERVICES,

Respondent-Appellee.

__________________________

2009-5132

__________________________

Appeal from the United States Court of Federal

Claims in 07-VV-137, Judge George W. Miller.

__________________________

MAYER, Circuit Judge, dissenting.

In my view, the special master and the Court of Fed-

eral Claims failed to properly apply our holdings in Althen

v. Secretary of Health & Human Services, 418 F.3d 1274

(Fed. Cir. 2005) and Andreu v. Secretary of Health &

Human Services, 569 F.3d 1367 (Fed. Cir. 2009). I there-

fore respectfully dissent.

Peter Broekelschen received an influenza vaccination

on October 28, 2005, at the age of 63. Approximately

seven weeks after receiving the vaccination, on December

16, 2005, Broekelschen was hospitalized with severe pain

in his chest, back, and shoulder. While in the hospital he

experienced a range of symptoms, including weakness in

BROEKELSCHEN v. HHS 2

his extremities and sensory deficits. Doctors performed

numerous tests, including several MRIs, computed tomo-

graphy scans, a lumbar puncture, and an angiogram, but

were unable to conclusively determine the cause of Broek-

elschen’s symptoms. Two diagnoses considered by the

treating physicians were transverse myelitis (“TM”), a

condition caused by inflammation of the spinal cord, and

anterior spinal artery syndrome, a condition caused by a

blocked blood vessel in the spinal cord. Broekelschen was

discharged on December 29, 2005, and transferred to a

rehabilitation facility. His discharge summary notes that

a diagnosis was not clearly established, but states that

the symptoms might be due to a post-vaccine immune

reaction. Several months after Broekelschen first experi-

enced symptoms his personal physician noted that, in the

absence of another working diagnosis, TM secondary to

the vaccination was the most likely cause.

Broekelschen filed a petition seeking compensation

under the National Childhood Vaccine Injury Act of 1986

(“Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34, alleging that

his symptoms were the result of vaccination induced TM.

The special master denied compensation, finding that

Broekelschen did not suffer from TM but from the alter-

native diagnosis of anterior spinal artery syndrome and

that there was insufficient evidence to support a theory

that this syndrome could be caused by the influenza

vaccine. Broekelschen sought review of the special mas-

ter’s decision in the Court of Federal Claims, which af-

firmed the decision of the special master denying

compensation.

In Althen, we described the burden for a vaccine in-

jury claimant as a three part test. In order to recover, the

claimant must show by preponderant evidence: (1) a

medical theory causally connecting the vaccination and

the injury, (2) a logical sequence of cause and effect show-

3 BROEKELSCHEN v. HHS

ing the vaccination was the reason for the injury, and (3)

a temporal relationship between the vaccination and the

injury. 418 F.3d at 1278. If the claimant is able to make

such a showing, the government is given the opportunity

to show by preponderant evidence that the injury was

caused by factors other than the vaccine. Id. In this case,

the special master recognized the applicability of the

Althen test, but decided that before applying the test it

was necessary to first determine a diagnosis for Broekel-

schen’s symptoms. The special master therefore looked at

the competing theories of Broekelschen’s diagnosis and

determined that Broekelschen suffered from anterior

spinal artery syndrome, as advanced by the government,

and not TM. Only then did the special master apply the

Althen test and determine that the evidence did not

support a finding that the vaccine caused anterior spinal

artery syndrome.

This approach, of first assigning a diagnosis to Broek-

elschen’s symptoms before applying the Althen test, is not

supported by statute, caselaw, or logic, and its effect was

to impermissibly heighten Broekelschen’s burden. Con-

trary to the majority, the language of the Vaccine Act does

not support the special master’s approach by narrowly

limiting its application to known injuries. Instead, it

broadly defines a “vaccine-related injury or death” as “an

illness, injury, condition, or death.” 42 U.S.C. § 300aa-

33(5). Petitions for compensation must demonstrate that

the claimant sustained “any illness, disability, injury, or

condition” caused by a vaccine. 42 U.S.C. § 300aa-

11(c)(1)(C)(ii)(I). Therefore, even in the absence of a

definitively diagnosed injury, claimants such as Broekel-

schen may experience an illness or disability that, with

the proper showing of causation, can meet the criteria for

a vaccine-related injury under the Vaccine Act.

BROEKELSCHEN v. HHS 4

The majority emphasizes that the parties’ dispute as

to the diagnosis makes this case unique and therefore

justifies the initial step of determining a diagnosis before

applying the Althen test. However, every case is unique

and nothing about the facts in this case supports the

majority’s unwarranted departure from our precedent. As

the special master recognized, the range of symptoms

Broekelschen experienced could be explained by either

diagnosis, and “determining which condition affects Dr.

Broekelschen is one step in determining the cause for Dr.

Broekelschen’s condition.” Broekelschen v. Sec’y of Health

& Human Servs., No. 07-137V, 2009 WL 440624 at *4

(Fed. Cl. Sp. Mstr. Feb. 4, 2009). Therefore, the analysis

of the diagnosis should have been part of the first prong of

the Althen test, which requires a “medical theory causally

connecting the vaccination and the injury.” 418 F.3d at

1278. The medical theory proposed by Broekelschen was

that his symptoms were caused by the vaccine through

the pathway of TM; his theory of causation is therefore

inextricably linked to the diagnosis. The special master

should have first determined whether Broekelschen

demonstrated that it was more likely than not that his

symptoms resulted from TM caused by an immune re-

sponse to the vaccine. Only then should the special

master have considered whether the government could

show by preponderant evidence that other factors caused

the injury, i.e., that Broekelschen’s symptoms were

caused by anterior spinal artery syndrome unrelated to

the influenza vaccine.

The majority cites to Doe v. Secretary of Health &

Human Services, 601 F.3d 1349 (Fed. Cir. 2010), in sup-

port of the proposition that the special master appropri-

ately considered the government’s alternative theory of

diagnosis prior to applying the Althen test. That reliance

is misplaced. In Doe we affirmed the decision of a special

5 BROEKELSCHEN v. HHS

master who allowed the government to present evidence

that the cause of death was sudden infant death syn-

drome (“SIDS”), rather than a vaccine, to rebut the claim-

ants’ theory of causation. Id. The claimants in that case,

however, relied on the elimination of SIDS as a potential

cause of death to establish their prima facie case, and the

special master considered the evidence relating to SIDS

only “in evaluating whether Doe’s proposed sequence of

cause and effect was plausible.” Id. at 1353. Here the

special master did not limit his evaluation of the govern-

ment’s theory of diagnosis to determining whether it

undercut the evidence Broekelschen presented to estab-

lish a prima facie case. Instead, he used diagnosis as a

prerequisite step, denying Broekelschen the opportunity

of even attempting to establish a prima facie case. In any

event, Doe does not overrule our precedent that a vaccine

claimant is not required to eliminate alternative causes of

injury in establishing a prima facie case. Id. at 1358 (“A

petitioner’s failure to meet his burden of proof as to the

cause of an injury or condition is different from a re-

quirement that he affirmatively disprove an alternative

cause.”); see also de Bazan v. Sec’y of Health & Human

Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008) (“So long as

the petitioner has satisfied all three prongs of the Althen

test, she bears no burden to rule out possible alternative

causes.”); Walther v. Sec’y of Health & Human Servs., 485

F.3d 1146, 1150 (Fed. Cir. 2007) (“[T]he Vaccine Act does

not require the petitioner to bear the burden of eliminat-

ing alternative causes where the other evidence on causa-

tion is sufficient to establish a prima facie case.”).

The special master also erred in basing his decision,

in part, on his view that the government’s expert witness

was more credible than Broekelschen’s. While the special

master praised the experience and demeanor of both

experts, he stated that he gave more weight to the gov-

BROEKELSCHEN v. HHS 6

ernment’s expert because he found the government’s

expert to have a more persuasive demeanor and a more

impressive background. Broekelschen, 2009 WL 440624

at *13, *18. This analysis is inappropriate for two rea-

sons. First, the Althen test does not support a head-to-

head comparison between dueling experts, but shifts the

burden to the government only after the claimant has

made a prima facie case for entitlement. The special

master therefore should not have analyzed which expert

was more persuasive, but whether Broekelschen’s expert,

along with the record evidence, showed that it was more

likely than not that Broekelschen’s condition was caused

by TM resulting from the vaccination. If so, the special

master’s analysis should have continued to determine

whether the government’s expert showed that it was more

likely than not that the condition was caused by factors

unrelated to the vaccine.

Second, while the credibility determinations of special

masters are owed deference, we have held that credibility

determinations are appropriately used to assess the

candor of a fact witness, “not to evaluate whether an

expert witness’ medical theory is supported by the weight

of epidemiological evidence.” Andreu, 569 F.3d at 1379.

In other words, credibility determinations can be used to

determine if an expert is reliable, but weighing the per-

suasiveness of the competing medical theories is a sepa-

rate analysis. Once the special master determined both

experts were highly qualified and reliable, there was no

reason for him to give any additional weight to the back-

ground or demeanor of the government’s expert. The

focus should have been solely on the “relative persuasive-

ness of the competing medical theories of the case.”

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

1362 (Fed. Cir. 2000).

7 BROEKELSCHEN v. HHS

Our decision in Moberly v. Secretary of Health & Hu-

man Services, 592 F.3d 1315 (Fed. Cir. 2010), in which we

affirmed the denial of a claim where the special master

discredited the testimony of the claimant’s expert, does

not support the approach taken by the special master in

this case. In Moberly, none of the treating physicians

expressed the view that the claimant’s injury was caused

by the vaccination she received. Instead, the record

evidence supporting the opinion of the claimant’s expert

“amount[ed] at most to a showing of temporal association

between a vaccination and a seizure, together with the

absence of any other identified cause for the . . . injury.”

Id. at 1323. In this case, contemporaneous records cre-

ated by treating physicians support Broekelschen’s the-

ory. Furthermore, the special master and both experts

noted that there is evidence in the record to support and

refute each of the two potential diagnoses. While nothing

in the record conclusively proves that Broekelschen’s

symptoms were caused by TM resulting from the vaccina-

tion, conclusive proof is not required. Knudsen v. Sec’y of

Heath & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir.

1994) (“The determination of causation in fact under the

Vaccine Act involves ascertaining whether a sequence of

cause and effect is ‘logical’ and legally probable, not

medically or scientifically certain.”); see also Althen, 418

F.3d at 1280 (“[T]he purpose of the Vaccine Act’s prepon-

derance standard is to allow the finding of causation in a

field bereft of complete and direct proof of how vaccines

affect the human body.”).

The majority holds that the special master’s error in

weighing the expert witnesses’ credibility is harmless.

This is mere speculation. It is not clear that the outcome

of the case would have been the same if the special master

had appropriately weighed the expert witness testimony,

particularly if he had done so within the prevailing

BROEKELSCHEN v. HHS 8

framework of Althen by allowing Broekelschen to attempt

to make a prima facie showing that his symptoms re-

sulted from vaccine-induced TM. I would therefore re-

mand to allow the special master to properly apply the

test laid out in Althen to Broekelschen’s claim and appro-

priately weigh the expert witness testimony.