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-l to -34 (“Vaccine Act” or “Act”).
Capizzano v. Sec’y of Health & Human Servs.,
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-l. 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-ll(c)(l), -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.,
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,
(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,
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 *1321 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 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,
(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 *23,
On September 30, 2003, the Court of Federal Claims issued its decision in
Althen v. Secretary of Health & Human Services,
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 mecha
*1322
nism by which a hepatitis B vaccine could cause rheumatoid arthritis.
Capizzano I,
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,
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. Capizza-no’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,
In formulating his new four-prong approach, the chief special master focused on the
Althen II
holding that “[cjausation in fact requires proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury.”
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.
Petitioner has not presented an epidemi-ologic 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.
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.,
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.
Tuner,
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.
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
Al-then II. Capizzano II,
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
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, (in) 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 causes, necessarily establishes “a logical sequence of cause and effect showing that the vaccination was the reason for the injury.”
The government responds that epidemi-ologic 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 Al-then 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,
Turning to the chief special master’s new four prong test, we conclude that requiring either epidemiologic studies, re-challenge, 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 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 causa *1326 tion 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-ll(c)(l),—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,
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,
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 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)(l)(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. *1328 Capizzano (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 Al-then II.
Accordingly, the decision of the Court of Federal Claims affirming the decision of the chief special master rejecting Ms. Cap-izzano’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.
Notes
. 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)(l)(B).
. See 42 U.S.C. § 300aa-12(c)-(d) for the provisions of the Vaccine Act relating to special masters.
. VAERS is the Vaccine Adverse Event Reporting System, a database maintained by the Centers for Disease Control.
. 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 hepatitis B vaccine and RA.
Capizzano I,
. 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.
. 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.
. In
Lowry v. Secretary of Health & Human Services,
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.
. 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).