Capizzano v. Secretary of Health and Human Services

United States Court of Appeals for the Federal Circuit

05-5049

ROSE CAPIZZANO,

Petitioner-Appellant,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent-Appellee.

Kevin P. Conway, Conway, Homer & Chin-Caplan, PC, of Boston,
Massachusetts, argued for petitioner-appellant. On the brief was Ronald C. Homer.

Vincent J. Matanoski, Attorney, United States Department of Justice, of
Washington, DC, argued for respondent-appellee. On the brief were Peter D. Keisler,
Assistant Attorney General, United States Department of Justice, of Washington, DC
and Ann K. Donohue, Trial Attorney, Torts Branch, Civil Division, United States
Department of Justice, of Washington, DC.

Appealed from: United States Court of Federal Claims

Senior Judge James F. Merow
 United States Court of Appeals for the Federal Circuit

05-5049

ROSE CAPIZZANO,

Petitioner-Appellant,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent-Appellee.

__________________________

DECIDED: March 9, 2006
__________________________

Before SCHALL, GAJARSA, and PROST, Circuit Judges.

SCHALL, Circuit Judge.

Rose Capizzano appeals the final decision of the United States Court of Federal

Claims that sustained the decision of the chief special master denying her petition for

compensation under the Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34

(“Vaccine Act” or “Act”). Capizzano v. Sec’y of Health & Human Servs., 63 Fed. Cl. 227

(2004) (“Capizzano II”). The chief special master ruled that Ms. Capizzano failed to

establish that the rheumatoid arthritis (sometimes “RA”) from which she suffers was

caused by an injection of hepatitis B vaccine that she received. Capizzano v. Sec’y of
Health & Human Servs., No. 00-759, 2004 U.S. Claims LEXIS 149, at *2-3, 95 (Fed. Cl.

Spec. Mstr. June 8, 2004) (“Capizzano I”). Because we conclude that the Court of

Federal Claims’ decision is inconsistent with Althen v. Secretary of Health & Human

Services, 418 F.3d 1274 (Fed. Cir. 2005) (“Althen III”), we vacate the decision and

remand the case to the Court of Federal Claims for further proceedings relating to

causation.

BACKGROUND

I.

We begin with a brief overview of the Vaccine Act. Subchapter XIX of Chapter

6A, Title 42, United States Code, enacted in 1986, established the National Vaccine

Program within the Department of Health and Human Services. The program was

established “to achieve optimal prevention of human infectious diseases through

immunization and to achieve optimal prevention against adverse reactions to vaccines.”

42 U.S.C. § 300aa-1. Subchapter XIX also established the National Vaccine Injury

Compensation Program, “under which compensation may be paid for a vaccine-related

injury or death.” Id. § 300aa-10(a). The Program is administered by the Secretary of

Health and Human Services. Id. An individual seeking compensation under the

Program must establish by a preponderance of the evidence that the injury or death at

issue was caused by a vaccine. Id. §§ 300aa-11(c)(1), -13(a)(1).

The Vaccine Act provides for the establishment of causation in one of two ways.

See Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 865 (Fed. Cir. 1992).

First, a petitioner may demonstrate (i) that the injury suffered is one listed in the Vaccine

Injury Table (“Table injury”), see 42 U.S.C. § 300aa-14(a); (ii) that the injury occurred

05-5049 2
within the time provided within the Table; and (iii) that the injury meets the requirements

of section 300aa-14(a). Munn, 970 F.2d at 865. In such a case, causation is

presumed. Id.1 Second, where the complained-of injury is not listed in the Vaccine

Injury Table (“off-Table injury”), the petitioner may prove causation in fact. See 42

U.S.C. §§ 300aa-13(a)(1), -11(c)(1)(C)(ii)(I). In such a case, the petitioner must prove

by a preponderance of the evidence that the vaccine at issue caused the injury. See

Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999);

Munn, 970 F.2d at 865.

A petition seeking compensation under the Vaccine Act is filed in the Court of

Federal Claims. 42 U.S.C. § 300aa-11(a)(1). After a petition is filed, the Clerk of the

Court forwards it to the chief special master for assignment to a special master.2 Id.

The special master to whom the petition is assigned “issue[s] a decision on such

petition with respect to whether compensation is to be provided under the [Vaccine Act]

Program and the amount of such compensation.” Id. § 300aa-12(d)(3)(A). The statute

requires that the special master’s decision be issued expeditiously and that it include

“findings of fact and conclusions of law.” Id.

The Vaccine Act provides that the Court of Federal Claims has jurisdiction to

review the record of the proceedings before the special master and that, following such

review, the court may:

(A) uphold the findings of fact and conclusions of law of the
special master and sustain the special master’s decision,

1
In such a case, the petitioner is entitled to compensation, as long as “there
is not a preponderance of the evidence that the . . . injury . . . is due to factors unrelated
to the administration of the vaccine . . . .” 42 U.S.C. § 300aa-13(a)(1)(B).
2
See 42 U.S.C. § 300aa-12(c)-(d) for the provisions of the Vaccine Act
relating to special masters.

05-5049 3
 (B) set aside any findings of fact or conclusion of law of the
special master found to be arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law and issue
its own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further
action in accordance with the court’s direction.

Id. § 300aa-12(e)(2). The findings of fact and conclusions of law of the Court of Federal

Claims can then be reviewed in the Federal Circuit. Id. § 300aa-12(f).

II.

The facts of this case are largely undisputed. Ms. Capizzano received her

second of three hepatitis B vaccine injections on May 3, 1998. Capizzano II, 63 Fed. Cl.

at 229. Within hours, she developed a rash on her abdomen. Id. Several days later,

her ailments increased to include stiff and painful joints. Id. Ms. Capizzano continues

to suffer from this permanent condition, taking daily medication to keep the pain,

swelling, and stiffness under control. Id. The government concedes that “[t]here is no

dispute that Ms. Capizzano is diagnosed with RA.” Because several vaccine recipients

had developed a worsening of already debilitating symptoms upon receiving an

additional dose of hepatitis B vaccine after being injured by a prior dose, Ms.

Capizzano’s physician decided that she should not receive a third hepatitis B

vaccination.

III.

On December 15, 2000, Ms. Capizzano filed a petition in the Court of Federal

Claims under the Vaccine Act seeking compensation for an off-Table injury. In due

course, the petition was forwarded to the chief special master, who assigned the case to

himself. Before turning to the proceedings before the chief special master, however, it

is important to note the legal backdrop against which this case was litigated because

05-5049 4
that backdrop influenced both the chief special master’s decision and the decision of the

Court of Federal Claims.

On March 23, 2001, the chief special master rendered his decision in Stevens v.

Secretary of Health & Human Services, No. 99-594V, 2001 U.S. Claims LEXIS 67 (Fed.

CI. Spec. Mstr. Mar. 30, 2001). In Stevens, the chief special master formulated a five-

prong analytical framework for determining whether a petitioner had met his or her

burden of establishing causation-in-fact in an off-Table injury case. Id. at *158. The

Stevens test required a claimant to prove the existence of the following five criteria by a

preponderance of the evidence:

(1) that it is medically plausible for a component of the
vaccine to cause the injury alleged,
(2) that the association between the vaccine and the alleged
injury is reported by peer-reviewed medical literature,
(3) that the vaccinee suffered an injury which is medically
accepted as a possible reaction to the vaccine,
(4) that the injury occurred within a medically accepted time
period, and
(5) that alternate causes were considered but otherwise
eliminated.
Id. at *158.

On September 30, 2003, the Court of Federal Claims issued its decision in

Althen v. Secretary of Health & Human Services, 58 Fed. Cl. 270 (2003) (“Althen II”),

reversing the chief special master’s decision in Althen v. Secretary of Health & Human

Services, No. 00-170V, 2003 U.S. Claims LEXIS 163 (Fed. CI. Spec. Mstr. June 3,

2003) (“Althen I”). In Althen I, the chief special master held that the petitioner, Margaret

Althen, was not entitled to compensation for her off-Table injury because she had failed

to establish the second prong of the five-prong Stevens test. Id. at *52. Specifically, the

special master found that Ms. Althen had failed to prove that the medical community

05-5049 5
was seeing, reporting, and discussing a potential relationship between the vaccine she

had received (hepatitis B vaccine) and her injury (rheumatoid arthritis). Id. In Althen II,

the Court of Federal Claims reversed the chief special master’s decision in Althen I

because it concluded that the Stevens framework was contrary to the Vaccine Act and

Federal Circuit precedent. 58 Fed. Cl. at 281-83. Accordingly, the court held that Ms.

Althen was entitled to compensation for her off-Table injury. Id. at 287. The

government timely appealed the court’s decision to this court. As indicated below in

Part II of the DISCUSSION section of this opinion, after briefing before us in Ms.

Capizzano’s case was completed, we decided Althen III, in which we affirmed Althen II’s

rejection of the Stevens framework.

We return now to Ms. Capizzano’s case. On June 11 and 12, 2003, the chief

special master held a hearing. At that hearing, Ms. Capizzano presented (i) her affidavit

concerning the timing and severity of her symptoms, (ii) her medical records, (iii) the

diagnoses of four treating physicians, (iv) VAERS data,3 and (v) the expert testimony of

Dr. David Bell concerning a mechanism by which a hepatitis B vaccine could cause

rheumatoid arthritis. Capizzano I, 2004 U.S. Claims LEXIS 149, at *2-3, 60-61, 88 n.42.

For its part, the government presented the testimony of Dr. Burton Zweiman, Dr. Paul A.

Phillips, and Dr. Lawrence Moulton. The government’s experts presented testimony

challenging Dr. Bell’s proposed mechanism by which rheumatoid arthritis is asserted to

be caused by hepatitis B vaccination.4 Capizzano II, 63 Fed. Cl. at 228. After post-trial

3
VAERS is the Vaccine Adverse Event Reporting System, a database
maintained by the Centers for Disease Control.
4
The chief special master rejected the testimony of Dr. Bell, Ms.
Capizzano’s expert, finding that the government’s experts were more persuasive and
“effectively rebutted” the contention that there exists a causal connection between the

05-5049 6
briefing, the chief special master rendered his decision in the case on June 8, 2004,

after the decision of the Court of Federal Claims in Althen II. As noted above, the chief

special master ruled that Ms. Capizzano had failed to establish that the rheumatoid

arthritis from which she suffered was caused by the hepatitis B vaccination she

received. Id. at *94-95.

In his opinion, the chief special master divided his analysis into two parts. First,

he addressed the question, “Can the hepatitis B vaccine cause RA?” Capizzano I, 2004

U.S. Claims LEXIS 149, at *49-59. After a thorough analysis, the chief special master

found that scientific and medical evidence shows that hepatitis B vaccine can cause RA.

Id. at *58-59. In so deciding, the chief special master relied on evidence of

“rechallenge” in other injectees. A rechallenge event occurs when a patient who had an

adverse reaction to a vaccine suffers worsened symptoms after an additional injection

of the vaccine. The chief special master stated that this evidence of rechallenge

constituted “such strong proof of causality that it is unnecessary to determine the

mechanism of cause—it is understood to be occurring.” Id. at *58.

The chief special master next addressed the precise question of whether

hepatitis B vaccine caused Ms. Capizzano’s rheumatoid arthritis. In light of Althen II,

the chief special master decided Ms. Capizzano’s case both under the five-prong

Stevens framework and under a new disjunctive four-prong approach that he designed

to satisfy what he perceived to be the requirements of Althen II. Capizzano II, 63 Fed.

Cl. at 230; Capizzano I, 2004 U.S. Claims LEXIS 149, at *59. The parties were in

(Cont’d. . . .)
hepatitis B vaccine and RA. Capizzano I, 2004 U.S. Claims LEXIS 149, at *87. Despite
rejecting Dr. Bell’s testimony, the chief special master nonetheless found that hepatitis
B vaccine can cause RA based on other evidence discussed below.

05-5049 7
agreement that Ms. Capizzano could not satisfy the second prong of the Stevens test,

involving a showing that “the association between the vaccine and the alleged injury is

reported by peer-reviewed medical literature.”

In formulating his new four-prong approach, the chief special master focused on

the Althen II holding that “[c]ausation in fact requires proof of a logical sequence of

cause and effect showing that the vaccination was the reason for the injury.” 58 Fed.

Cl. at 280. Under the chief special master’s new approach, Ms. Capizzano was

required to demonstrate the presence of one of the following four types of evidence to

satisfy the “logical sequence of cause and effect” requirement of Althen II: epidemiologic

studies; rechallenge; presence of pathological markers or genetic predisposition; or

general acceptance in the scientific and medical communities that hepatitis B

vaccination can cause rheumatoid arthritis. Capizzano I, 2004 U.S. Claims LEXIS 149,

at *59. The chief special master noted that there may be other means of proving

causation in fact, but that he was unaware of any. Id. at *47-48.

Applying his four-prong approach, the chief special master found “that petitioner

has not proven by a preponderance of the evidence any of these means of establishing

causation, or any other method proposed by petitioner, and thus failed to prove that the

hepatitis B vaccine caused her RA.” Id. at *59. As noted, Ms. Capizzano presented

diagnoses from her four treating physicians. These doctors attributed her rheumatoid

arthritis to her hepatitis B vaccination. The chief special master rejected these

diagnoses, reasoning that they were based primarily on the temporal relationship

between the vaccination and the onset of Ms. Capizzano’s rheumatoid arthritis. Id. at

*88 n.42. The chief special master concluded:

05-5049 8
 Petitioner has not presented an epidemiologic study, nor has
she presented evidence of general acceptance—i.e., that the
medical community is currently “seeing” or “talking about” a
potential relationship between the vaccine and the injury.
Furthermore, factually she has not established that she
experienced a rechallenge event or that she possesses the
genetic markers that her expert testified were necessary to
link the development of the disease to the vaccine that she
received on May 3, 1998. Finally, she has failed to show
that the mechanism proposed by her expert is linked to the
occurrence of her RA because evidence shows that the
mechanism is more conceptual and theoretical than “actual.”
Id. at *96.

Ms. Capizzano appealed the chief special master’s decision to the Court of

Federal Claims, which rendered a decision in the case on December 7, 2004.

Capizzano II. Under the Vaccine Act, “the Court of Federal Claims may set aside the

decision of a special master only if the special master’s fact findings are arbitrary and

capricious, its legal conclusions are not in accordance with law, or its discretionary

rulings are an abuse of discretion.” Turner v. Sec’y of Health & Human Servs., 268 F.3d

1334, 1337 (Fed. Cir. 2001) (citing 42 U.S.C. § 300aa-12(e)(2)(B)). Applying this

standard of review, the Court of Federal Claims affirmed both the chief special master’s

findings of fact and legal conclusions. Capizzano II, 63 Fed. Cl. at 231. The court

determined that the disjunctive four-prong test employed by the chief special master

was not contrary to law and affirmed the special master’s factual findings with respect to

each factor as not arbitrary or capricious. Id. The court observed, “Given the number of

persons receiving hepatitis B vaccine and the percentage of the population developing

RA, there are bound to be persons receiving the vaccine who would, in any event,

develop RA.” Id. at 230. Ms. Capizzano timely appealed the Court of Federal Claims’

decision to this court.

05-5049 9
 DISCUSSION

I.

We have jurisdiction over this appeal pursuant to 42 U.S.C. § 300aa-12(f). In an

appeal from a decision of the Court of Federal Claims in a Vaccine Act case, we apply

the same standard of review that the Court of Federal Claims applied to the special

master’s decision. Turner, 268 F.3d at 1337; accord Lampe v. Sec’y of Health &

Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000). “Because we review the trial

court’s legal determination that the special master acted in a manner not in accordance

with law de novo, we effectively review the special master’s decision under the same

standard.” Althen III, 418 F.3d at 1277-78 (citing Hines v. Sec’y of Health & Human

Servs., 940 F.2d 1518, 1524 (Fed. Cir. 1991)); accord Turner, 268 F.3d at 1337. We

also determine anew whether the chief special master’s findings of fact were arbitrary or

capricious. Lampe, 219 F.3d at 1360; accord Turner, 268 F.3d at 1337.

II.

On July 29, 2005, after briefing in this appeal was completed, we issued our

decision in Althen III. In Althen III, we affirmed the decision of the Court of Federal

Claims in Althen II. 418 F.3d at 1282. In doing so, we held “that the special master’s

application of the Stevens test was contrary to law.” Id. at 1281. We stated that “[t]he

government’s suggestion that prong two of Stevens does not impermissibly raise

Althen’s burden, ignores the legal and practical effect of that test: by requiring medical

literature, it contravenes section 300aa-13(a)(1)’s allowance of medical opinion as

proof.” Id. at 1280. We continued:

05-5049 10
 This prevents the use of circumstantial evidence envisioned
by the preponderance standard and negates the system
created by Congress, in which close calls regarding
causation are resolved in favor of injured claimants. See
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543,
549 (Fed. Cir. 1994) (explaining that “to require identification
and proof of specific biological mechanisms would be
inconsistent with the purpose and nature of the vaccine
compensation program”). While [Althen’s petition] involves
the possible link between [tetanus toxoid] vaccination and
central nervous system injury, a sequence hitherto unproven
in medicine, the purpose of the Vaccine Act’s preponderance
standard is to allow the finding of causation in a field bereft
of complete and direct proof of how vaccines affect the
human body.
Id.

Finally, in Althen III, we set forth a three-part test for determining causation-in-

fact in off-Table Vaccine Act cases. We held that a petitioner’s

burden is to show by preponderant evidence that the
vaccination brought about her injury by providing: (1) a
medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing
that the vaccination was the reason for the injury; and (3) a
showing of a proximate temporal relationship between
vaccination and injury.

Id. at 1278.

Our task in this case is straightforward. We must determine whether the decision

of the Court of Federal Claims sustaining the decision of the chief special master is

consistent with Althen III. In other words, does the four-prong test employed by the

chief special master in this case pass muster under Althen III?

III.

As noted above, the chief special master decided Ms. Capizzano’s case under

both the five-part Stevens test and the four-prong test he developed following the Court

of Federal Claims’ decision in Althen II. Capizzano II, 63 Fed. Cl. at 230; Capizzano I,

05-5049 11
2004 U.S. Claims LEXIS 149, at *59. Applying his new four-part test that he devised in

response to Althen II, the chief special master denied Ms. Capizzano’s claim for failing

to satisfy any of the four means of showing a “logical sequence of cause and effect”

(epidemiologic studies, rechallenge, pathological markers, general acceptance).

Capizzano I, 2004 U.S. Claims LEXIS 149, at *59.

Viewing the case through the lens of Althen III, it seems clear—and the parties to

do not dispute—that the chief special master and the Court of Federal Claims denied

Ms. Capizzano’s claim because they in effect determined that she had failed to meet the

second prong of Althen III by not demonstrating “a logical sequence of cause and effect

showing that the vaccination was the reason for the injury.”5 418 F.3d at 1278. There is

no dispute that the first and third prongs of Althen III were satisfied.

Ms. Capizzano argues that the requirement of epidemiologic studies,

rechallenge, pathological markers, or general acceptance is inconsistent with Althen III

and impermissibly raises a claimant’s burden. She further argues that the combination

of (i) her affidavit concerning the timing and severity of her symptoms, (ii) her medical

records, (iii) the diagnoses of four physicians who treated her, (iv) the VAERS data, and

(v) the lack of anything else but coincidence that could have caused her RA constitute

more than enough evidence to satisfy the second prong of Althen III. In any event, Ms.

Capizzano urges, even in the absence of evidence satisfying the second prong of

Althen III, satisfying the first and third prongs, combined with the elimination of other

5
We say “in effect determined” because when they rendered their decisions
in this case, neither the chief special master nor the Court of Federal Claims had the
benefit of Althen III.

05-5049 12
causes, necessarily establishes “a logical sequence of cause and effect showing that

the vaccination was the reason for the injury.”

The government responds that epidemiologic studies, rechallenge, pathological

markers, and general acceptance are merely four ways to satisfy the second prong of

Althen III. The government argues that what the second prong requires varies from

case to case. Further, the government urges that although medical records and

medical opinion could be enough to satisfy the second prong of Althen III in some

cases, they were insufficient in this case. According to the government, Ms. Capizzano

needed to present a reputable scientific explanation for receiving rheumatoid arthritis

from the hepatitis B vaccine.

In Althen III, we pointed to our decision in Knudsen, which explained that “to

require identification and proof of specific biological mechanisms would be inconsistent

with the purpose and nature of the vaccine compensation program.” Althen III, 418 F.3d

at 1280 (quoting Knudsen, 35 F.3d at 549). We then stated that “[w]hile [Althen’s

petition] involves the possible link between [tetanus toxoid] vaccination and central

nervous system injury, a sequence hitherto unproven in medicine, the purpose of the

Vaccine Act’s preponderance standard is to allow the finding of causation in a field

bereft of complete and direct proof of how vaccines affect the human body.” 418 F.3d

at 1280 (emphases added).

Turning to the chief special master’s new four prong test, we conclude that

requiring either epidemiologic studies, rechallenge, the presence of pathological

markers or genetic disposition, or general acceptance in the scientific or medical

communities to establish a logical sequence of cause and effect is contrary to what we

05-5049 13
said in Althen III. We think such an approach is inconsistent with allowing “the use of

circumstantial evidence envisioned by the preponderance standard.” Id. In our view, it

thus impermissibly raises a claimant’s burden under the Vaccine Act and hinders “the

system created by Congress, in which close calls regarding causation are resolved in

favor of injured claimants.” Id.

“A logical sequence of cause and effect” means what it sounds like—the

claimant’s theory of cause and effect must be logical. Congress required that, to

recover under the Vaccine Act, a claimant must prove by a preponderance of the

evidence that the vaccine caused his or her injury. 42 U.S.C. §§ 300aa-11(c)(1), -

13(a)(1).6

In the present case, the first prong of the Althen III test was satisfied by the

finding that the hepatitis B vaccine can cause RA. Capizzano I, 2004 U.S. Claims

LEXIS 149, at *59. The third prong was satisfied by the finding that Ms. Capizzano’s

RA appeared within days of receiving the vaccine. Id. at *2-3. As far as the second

prong is concerned, in our view, the chief special master erred in not considering the

opinions of the treating physicians who concluded that the vaccine was the cause of Ms.

Capizzano’s injury. See id. at *3. The fact that these physicians’ diagnoses may have

6
As already seen, in Althen III, we held that a petitioner’s burden with
respect to causation

is to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination
and injury.

418 F.3d at 1278.

05-5049 14
relied in part on the temporal proximity of Ms. Capizzano’s injuries to the administration

of the vaccine is not disqualifying. See id. at *88 n.42. We see no reason why evidence

used to satisfy one of the Althen III prongs cannot overlap to satisfy another prong. In

other words, if close temporal proximity, combined with the finding that hepatitis B

vaccine can cause RA, demonstrates that it is logical to conclude that the vaccine was

the cause of the RA (the effect), then medical opinions to this effect are quite probative.

Moreover, Althen III explained that medical records and medical opinion testimony are

favored in vaccine cases, as treating physicians are likely to be in the best position to

determine whether “a logical sequence of cause and effect show[s] that the vaccination

was the reason for the injury.” 418 F.3d at 1280; see also 42 USC § 300aa-13(a)(1)

(“The special master or court may not make . . . a finding [of causation] based on the

claims of a petitioner alone, unsubstantiated by medical records or by medical

opinion.”).

We recognize, as the Court of Federal Claims observed, that the immense

number of people receiving the hepatitis B vaccine statistically results in instances

where individuals suffer an initial onset of rheumatoid arthritis shortly after receiving the

vaccine, but not as the result of the vaccine. Capizzano II, 63 Fed. Cl. at 230.

However, the statute requires only that the claimant show that it is more likely than not

that this claimant’s RA was caused by the vaccine. See Althen III, 418 F.3d at 1279

(“This court has interpreted the ‘preponderance of the evidence’ standard referred to in

the Vaccine Act as one of proof by a simple preponderance, of ‘more probable than not’

causation.” (citing Hellebrand v. Sec’y of Health & Human Servs., 999 F.2d 1565, 1572-

73 (Fed. Cir. 1993))). The fact that there is a possibility that the rheumatoid arthritis that

05-5049 15
appeared immediately after Ms. Capizzano received her vaccination was not caused by

the vaccination does not prevent a finding that it is more likely than not that the vaccine

caused the RA. See Althen III, 418 F.3d at 1280 (“[C]lose calls regarding causation are

resolved in favor of injured claimants.”).7

The second prong of the Althen III test is not without meaning. There may well

be a circumstance where it is found that a vaccine can cause the injury at issue and

where the injury was temporally proximate to the vaccination, but it is illogical to

7
In Lowry v. Secretary of Health & Human Services, 189 F.3d 1378 (Fed.
Cir. 1999), we explained:

The Act’s National Vaccine Program was established to
develop new vaccines, improve existing vaccines, and
compensate individuals who have been injured by vaccines
routinely administered to children. See H.R. Rep. 99-908, at
1, reprinted in 1986 U.S.C.C.A.N. 6344, 6344. Congress
instituted this compensatory program because the traditional
civil tort actions against vaccine manufacturers were
producing undesirable results both with respect to the
victims and the vaccine industry. See id., at 6-7, reprinted in
U.S.C.C.A.N. at 6347-48. Congress found that the
traditional tort system was not working for victims because it
resulted in lengthy delays, high transaction costs, and
sometimes no recovery. See id. Similarly, the high cost of
litigation and difficulty of obtaining insurance was
undermining incentives for vaccine manufacturers to remain
in the vaccine market. In sum, Congress was concerned
with the instability and unpredictability in the childhood
vaccine market. See id. To deal with these problems,
Congress established a federal “no-fault” compensation
program under which awards were to be made to vaccine-
injured persons “quickly” and with “generosity.” See id., at 1,
reprinted in 1986 U.S.C.C.A.N. at 6344.

189 F.3d at 1381; accord Knudsen, 35 F.3d at 549 (“The Vaccine Act does not
contemplate full blown tort litigation in the Court of Federal Claims. The Vaccine Act
established a federal compensation program under which awards are to be made to
vaccine-injured persons quickly, easily, and with certainty and generosity.”) (internal
quotation marks omitted).

05-5049 16
conclude that the injury was actually caused by the vaccine. A claimant could satisfy

the first and third prongs without satisfying the second prong when medical records and

medical opinions do not suggest that the vaccine caused the injury, or where the

probability of coincidence or another cause prevents the claimant from proving that the

vaccine caused the injury by preponderant evidence. See 42 U.S.C. § 300aa-

13(a)(1)(B) (“Compensation shall be awarded . . . if the special master or court finds on

the record as a whole . . . that there is not a preponderance of the evidence that the . . .

injury . . . is due to factors unrelated to the administration of the vaccine described in the

petition.”).

CONCLUSION

The chief special master rejected Ms. Capizzano’s claim under the Vaccine Act

because she failed to establish causation for her off-Table injury using one of the

prongs of the four-prong test that the chief special master formulated in the wake of

Althen II. We hold that this was error. While each of the prongs in the chief special

master’s test certainly could be probative of causation, we think that it is incorrect to

require a petitioner to establish one of the four prongs in order to show causation. That

is because, for the reasons stated above, we think that the special master’s four-prong

test impermissibly heightens the burden of proof placed upon a petitioner in an off-Table

injury case by restricting the way in which the petitioner can prove his or her case. The

proper inquiry is whether a petitioner in an off-Table injury case establishes a logical

sequence of cause and effect, the second prong of Althen III, by a preponderance of the

evidence. That approach has not yet been followed in this case because there has not

yet been, in the first instance, an analysis of the evidence presented by Ms. Capizzano

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(i) under the teaching of Althen III and (ii) unencumbered by the constraints of the four-

prong test formulated by the chief special master following Althen II.

Accordingly, the decision of the Court of Federal Claims affirming the decision of

the chief special master rejecting Ms. Capizzano’s claim for compensation is vacated.

The case is remanded to the Court of Federal Claims to determine whether Ms.

Capizzano has proven causation by a preponderance of the evidence based on the

existing record.8 If Ms. Capizzano has proven causation, judgment should be entered in

her favor. If not, her claim should be denied.

COSTS

Each party shall bear its own costs.

VACATED and REMANDED.

8
We leave it to the Court of Federal Claims, after receiving the views of the
parties, to decide whether, in the first instance, the matter should be decided by the
chief special master. See 42 U.S.C. § 300aa-12(e)(2).

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