United States Court of Appeals for the Federal Circuit 

2008-5013 

ADELA QUINTANA DE BAZAN, 

 Petitioner-Appellee, 

v. 

SECRETARY OF HEALTH AND HUMAN SERVICES, 

 Respondent-Appellant. 

Peter G. Lomhoff, of Oakland, California, argued for petitioner-appellee. 

Heather L. Pearlman, Trial Attorney, Torts Branch, Civil Division, United States 

Department of Justice, of Washington, DC, argued for respondent-appellant. With her 

on the brief were Jeffrey S. Bucholtz, Acting Assistant Attorney General, Timothy P. 

Garren, Director, Vincent J. Matanoski, Acting Deputy Director, and Gabrielle M. 

Fielding, Assistant Director. 

Appealed from: United States Court of Federal Claims 

Judge Charles F. Lettow 
United States Court of Appeals for the Federal Circuit 

2008-5013 

ADELA QUINTANA DE BAZAN, 

Petitioner-Appellee, 

v. 

SECRETARY OF HEALTH AND HUMAN SERVICES, 

Respondent-Appellant. 

Appeal from the United States Court of Federal Claims in case no. 03-VV-620, Judge 

Charles F. Lettow. 

__________________________ 

DECIDED: August 28, 2008 

__________________________ 

Before MICHEL, Chief Judge, FRIEDMAN, Senior Circuit Judge, and RADER, Circuit 

Judge. 

MICHEL, Chief Judge. 

Respondent-Appellant Secretary of Health and Human Services appeals from 

the final judgment of the United States Court of Federal Claims awarding compensation 

to Petitioner-Appellee Adela Quintana de Bazan under the Vaccine Injury 

Compensation Program ("Vaccine Program") established by the National Childhood 

Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 ("Vaccine Act"). 

Because we hold that the Court of Federal Claims erred as a matter of law in 

reversing the special master's original entitlement ruling, we reverse. 

 
I. BACKGROUND 

The basic facts are undisputed. At about 11:00 am on April 19, 2000, Bazan 

received a tetanus typhoid-diptheria ("Td") vaccine. Within approximately eleven hours, 

Bazan began experiencing symptoms, such as soreness and numbness, associated 

with the onset of acute disseminated encephalomyelitis ("ADEM").1 These symptoms 

grew progressively worse over the next week until by May 2, 2000, she could not walk 

without assistance, and she sought emergency medical attention. She was admitted to 

a hospital on May 8, 2000, and was thereafter diagnosed with ADEM. Currently, Bazan 

is a quadriplegic. 

 Bazan filed a petition under the Vaccine Program on March 19, 2003. The 

special master held two evidentiary hearings at which expert testimony and other 

evidence was submitted. On February 7, 2006, the special master issued his decision 

denying Bazan's petition, holding that she had failed to prove a requisite element of her 

prima facie case—that her injuries occurred within a "medically appropriate time frame" 

in relation to the administration of the vaccine. Crediting the testimony of the 

government's expert, Dr. Subramaniam Sriram, the special master found that the eleven 

hours between the administration of the Td vaccine and the onset of the first stages of 

Bazan's ADEM was too little time to be medically appropriate to link them, i.e., that it 

would have taken longer for ADEM to appear if it had been triggered by the vaccine. 

 1

 ADEM is an autoimmune disorder in which the body's immune system, in 

response to some triggering event, attacks and destroys the myelin sheathing around 

the neurons of the central nervous system ("CNS"). Myelin sheathing allows neurons to 

transmit signals at very fast speeds. If neurons become demyelinated, such as through 

ADEM, they transmit signals much more slowly and, in severe cases, they are unable to 

transmit signals at all. As a result, the brain's ability to communicate with the body is 

significantly impaired or eradicated. 

2008-5013 2 
 On a motion for review, the Court of Federal Claims held that the special master 

had erred by improperly failing to shift the burden to the government. The court held 

that the finding that the eleven-hour onset of ADEM was not within a medically 

appropriate timeframe to attribute to the vaccine was tantamount to finding that Bazan 

had failed to prove that no other cause could have caused her injuries. Holding that the 

statute and case law place the burden on the government to prove alternative 

causation, the court reviewed the evidence and concluded that Bazan had established a 

prima facie case. The court thus reversed and remanded to the special master to afford 

the government the opportunity to prove alternative causation. 

 On remand, the government submitted no further evidence; thus, the special 

master held that Bazan is entitled to compensation. The Court of Federal Claims 

affirmed the special master's remand decision. After further proceedings concerning 

damages, final judgment was entered for Bazan and damages were awarded. The 

government then timely filed this appeal. We have jurisdiction under 28 U.S.C. 

§ 1295(a)(3). 

II. DISCUSSION 

A. 

Under the Vaccine Act, the Court of Federal Claims reviews the decision of the 

special master to determine if it is "arbitrary, capricious, an abuse of discretion, or 

otherwise not in accordance with law[.]" 42 U.S.C. § 300aa-12(e)(2)(B); Althen v. Sec'y 

of Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005). We review legal 

determinations of the Court of Federal Claims de novo. Althen, 418 F.3d at 1278. To 

the extent that the Court of Federal Claims adopts factual findings made by the special 

2008-5013 3 
master, we accord them the same deference as the Court of Federal Claims and review 

them under the arbitrary and capricious standard as provided in the statute. Munn v.

Sec'y of the Dep't of Health & Human Servs., 970 F.2d 863, 870 (Fed. Cir. 1992). 

When the Court of Federal Claims makes its own factual findings either in the first 

instance or when it has found the special master's findings arbitrary and capricious, we 

review those findings for clear error. Id. at 871-72; see also Althen, 418 F.3d at 1278. 

B. 

As part of her burden of proof, the petitioner must establish that her injuries were 

caused by a vaccine listed on the Vaccine Injury Table ("Table"). See 42 U.S.C. 

§ 300aa-11(c)(1)(C). The petitioner may meet this burden as to causation in either of 

two ways. First, causation is presumed if the petitioner can demonstrate by a 

preponderance of the evidence that her injury meets the criteria in the Table. Grant v. 

Sec'y of the Dep't of Health & Human Servs., 956 F.2d 1144, 1146-47 (Fed. Cir. 1992). 

The Table lists symptoms and injuries associated with each listed vaccine and a 

timeframe for each symptom or injury. 42 U.S.C. § 300aa-14. Congress has thus 

determined that if a petitioner can establish that she received a listed vaccine and 

experienced such symptoms or injuries within the specified timeframes, she has met her 

prima facie burden to prove that the vaccine caused her injuries. 

If, as here, the petitioner has suffered an injury that is not listed on the Table, or if 

the petitioner suffered an injury listed on the Table but not within the specified 

timeframe, she is not afforded a presumption of causation and thus must prove 

causation-in-fact. Grant, 956 F.2d at 1147-48. We have held that causation-in-fact in 

the Vaccine Act context is the same as "legal cause" in the general torts context. 

2008-5013 4 
Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). 

Therefore, drawing from the Restatement (Second) of Torts, the vaccine is a cause-infact when it is "a substantial factor in bringing about the harm."2

 See Restatement 

(Second) of Torts § 431(a). 

We observed in Shyface that the "substantial factor" standard requires a greater 

showing than "but for" causation. 165 F.3d at 1352. The Restatement addresses "but 

for" causation by stating that "the actor's negligent conduct is not a substantial factor in 

bringing about harm to another if the harm would have been sustained even if the actor 

had not been negligent." Restatement (Second) of Torts § 432(1). Therefore, "but for" 

causation requires that the harm be attributable to the vaccine to some non-negligible 

degree. But, as we explained in Shyface, a merely non-negligible contribution to the 

harm is insufficient because the vaccine must have been a substantial factor in bringing 

about the harm. Shyface, 165 F.3d at 1352. However, the petitioner need not show 

that the vaccine was the sole or predominant cause of her injury, just that it was a 

substantial factor. Walther v. Sec'y of Health & Human Servs., 485 F.3d 1146, 1150 

(Fed. Cir. 2007) (citing Shyface, 165 F.3d at 1352). Applying these principles to the 

Vaccine Act context, we have held that the petitioner, to meet her burden as to 

causation-in-fact, must establish 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 

showing of a proximate temporal relationship between vaccination and injury." Althen, 

 2

 The Restatement also provides for an exception when there is a "rule of 

law relieving the actor from liability because of the manner in which his negligence has 

resulted in the harm." Restatement (Second) of Torts § 431(b). However, this part of 

the tort law causation rule is not implicated here. 

2008-5013 5 
418 F.3d at 1278. It is undisputed here that Bazan has met the first two prongs of the 

Althen test. 

With regard to the "proximate temporal relationship" prong, the present case 

presents an unusual situation in that the basis for the special master's finding that 

Bazan had failed to prove a proximate temporal relationship was that the onset of her 

ADEM was too early to be attributable to the vaccine. Usually, a petitioner's failure to 

satisfy the proximate temporal relationship prong is due to the fact that onset was too 

late after the administration of a vaccine for the vaccine to be the cause. See, e.g., 

Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352, 1358 (Fed. Cir. 2006) ("If, 

for example, symptoms normally first occur ten days after inoculation but petitioner's 

symptoms first occur several weeks after inoculation, then it is doubtful the vaccination 

is to blame."). But we see no reason to distinguish between cases in which onset is too 

soon and cases in which onset is too late; in either case, the temporal relationship is not 

such that it is medically acceptable to conclude that the vaccination and the injury are 

causally linked. Thus, the proximate temporal relationship prong requires preponderant 

proof that the onset of symptoms occurred within a timeframe for which, given the 

medical understanding of the disorder's etiology, it is medically acceptable to infer 

causation-in-fact. See id.; see also Althen, 418 F.3d at 1281 (equating "proximate 

temporal relationship" with "medically-acceptable temporal relationship"). 

Once the petitioner has established a prima facie case for entitlement to 

compensation and thus met her burden to prove causation-in-fact, the burden shifts to 

the government to prove "[by] a preponderance of the evidence that the [petitioner's 

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

2008-5013 6 
petition." See 42 U.S.C. § 300aa-13(a)(1)(B); Walther, 485 F.3d at 1150. If the 

government fails to meet this burden, the petitioner is entitled to compensation. So long 

as the petitioner has satisfied all three prongs of the Althen test, she bears no burden to 

rule out possible alternative causes.3

 Walther, 485 F.3d at 1149-50. 

C. 

 We turn now to the facts of this case. Bazan presented evidence primarily in the 

form of the testimony of her treating neurologist, Dr. Susan Hansen. Dr. Hansen relied 

on a number of scientific studies and articles. The government countered with the 

testimony of their own expert, Dr. Sriram, and his supporting documentary evidence. 

The special master noted the extensive credentials of both experts.4

 Dr. Hansen 

opined that ADEM caused by a Td vaccination could manifest as soon as eleven hours 

after the administration of the vaccine. She relied on several ADEM case studies, but 

the special master found that these studies did not evidence any instances where 

ADEM onset occurred as soon as eleven hours after vaccination. The Court of Federal 

Claims later agreed on review. Dr. Hansen also relied on case studies involving 

demyelinating disorders of the peripheral nervous system ("PNS"). The special master 

 3

 As we explained in Walther, we have held that a petitioner may instead

rule out possible alternative causes to prove causation-in-fact when evidence as to the 

Althen requirements is insufficient. Walther, 485 F.3d at 1149-50; see Pafford v. Sec'y 

of Health & Human Servs., 451 F.3d 1352, 1357-59 (Fed. Cir. 2006) (holding that the 

petitioner's failure to eliminate other potential causes was fatal to the petition when she 

had not provided evidence of a proximate temporal relationship between the vaccine 

and her injury). 

4

 The government argues that the Court of Federal Claims erred by 

discounting the special master's consideration of the medical evidence without an 

analysis under Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993). However, 

Daubert is inapposite here because the special master did not exclude any expert 

evidence under Daubert. Rather, the special master admitted and weighed both parties' 

evidence but simply decided that the government's evidence was more persuasive. 

2008-5013 7 
found, however, that the myelin of the PNS is different from that of the CNS and thus 

the timeframes of PNS disorders are not probative of timeframes in CNS disorders like 

ADEM. 

The special master's findings as to Dr. Hansen's evidence were largely based on 

the testimony of Dr. Sriram, which the special master credited as more probative and 

reliable than that of Dr. Hansen. Dr. Sriram testified that, based on animal studies of 

ADEM, ten to fourteen days are required for ADEM to manifest after vaccination. He 

explained that, under the medical theory of causation involved here, the immune system 

would not produce sufficient levels of cytokines (the molecules responsible for the 

myelin destruction) in the CNS until ten to fourteen days had passed. Crediting this 

testimony, the special master concluded that Bazan had not proven by a preponderance 

that eleven hours is a medically acceptable timeframe within which ADEM could 

manifest after her vaccination, and that Bazan had failed to prove the "proximate 

temporal relationship" element of her prima facie case as a result. 

The Court of Federal Claims held that by accepting the government's evidence, 

which indicated that Bazan's symptoms arose too early to attribute to the vaccine, the 

special master erred by effectively requiring Bazan to eliminate alternative causes. The 

court reasoned that finding that her injuries occurred too soon for the vaccine to be the 

cause was tantamount to finding that her injuries were the result of an alternative cause. 

Citing our precedents, the court held that any proof relating to alternative causation is 

part of the government's rebuttal case under § 300aa-13(a)(1)(B) and not the 

petitioner's case-in-chief. However, the court misunderstood our precedents. 

2008-5013 8 
It is certainly true that a finding that the administration of a vaccine was not a 

cause-in-fact of an injury necessarily implies that some other cause resulted in the 

injury, assuming the injury itself is proven. Nevertheless, it is clearly the petitioner's 

burden to prove that the vaccine was a cause-in-fact of her injuries, including proving a 

proximate temporal relationship. Althen, 418 F.3d at 1278. Thus, in enforcing that 

burden, the special master was not imposing an additional burden to eliminate 

alternative causes. 

Bazan argues that the gravamen of the holding of the Court of Federal Claims is 

that the special master must ignore any government evidence that tends to show that 

the temporal relationship between the vaccination and the onset of the petitioner's 

injuries was not medically appropriate when evaluating whether the petitioner met her 

burden as to causation. But this holding has no support in the statute or case law. The 

government, like any defendant, is permitted to offer evidence to demonstrate the 

inadequacy of the petitioner's evidence on a requisite element of the petitioner's casein-chief. Bazan has identified no statute, regulation, or precedent that indicates that the 

special master is required to only consider the petitioner's evidence as to whether the 

vaccine was a cause-in-fact. 

Further, the petitioner's case-in-chief concerns the medical evidence relating to 

the possible role the vaccine had in causing her injury. The government's burden, in 

contrast, concerns "factors unrelated to the administration of the vaccine described in 

the petition." See 42 U.S.C. § 300aa-13(a)(1)(B). While a failure of proof that the 

vaccine was the cause of the petitioner's injury suggests that some other cause was 

responsible, that is not equivalent to having proven by preponderant evidence that a 

2008-5013 9 
2008-5013 10 

particular agent or condition (or multiple agents/conditions) unrelated to the vaccine was 

in fact the sole cause (thus excluding the vaccine as a substantial factor). This latter 

showing is the government's burden once the petitioner has met her burden. In other 

words, successfully proving the elements of the Althen test establishes that the medical 

evidence indicating that the vaccine may have caused the petitioner's injury is strong 

enough to infer causation-in-fact absent proof that some other factor was the actual 

cause. The government then must provide that proof by identifying a particular such 

factor (or factors) and presenting sufficient evidence to establish that it was the sole 

substantial factor in bringing about the injury. Knudsen v. Sec'y of the Dep't of Health & 

Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). 

Here, the government's evidence did not concern any factors unrelated to the 

vaccine. Rather, Dr. Sriram's testimony bore directly on whether the medical evidence 

supported concluding that the vaccine could be the cause-in-fact, which is clearly part of 

the petitioner's case-in-chief. Therefore, the special master's reliance on the 

government's evidence was lawful, and we discern no other error in the special master's 

evaluation of this evidence, the petitioner's evidence, or in his determination that Dr. 

Sriram's testimony was more credible and probative than that of Dr. Hansen. 

CONCLUSION 

For the reasons provided above, the judgment of the Court of Federal Claims is 

REVERSED.