Lisa Ann Pafford v. Secretary of Health and Human Services

United States Court of Appeals for the Federal Circuit
05-5106
LISA ANN PAFFORD
and RICHARD LEON PAFFORD,
Parents and Next Friends of
Richelle Lorrae Pafford, a minor,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent-Appellee.
Robert T. Moxley, Gage and Moxley, of Cheyenne, Wyoming, argued for
petitioners-appellants.
Melonie J. McCall, Trial Attorney, Torts Branch, Civil Division, United States
Department of Justice, of Washington, DC, argued for respondent-appellee. With her
on the brief were Peter D. Keisler, Assistant Attorney General and Timothy P. Garren,
Director, and Vincent J. Matanoski, Assistant Director.
Appealed from: United States Court of Federal Claims
Judge Lawrence J. Block

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United States Court of Appeals for the Federal Circuit
05-5106
LISA ANN PAFFORD
and RICHARD LEON PAFFORD,
Parents and Next Friends of
Richelle Lorrae Pafford, a minor,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent-Appellee.
___________________________
DECIDED: June 20, 2006
___________________________
Before LOURIE, RADER, and DYK, Circuit Judges.
Opinion for the court filed by Circuit Judge RADER. Dissenting opinion filed by Circuit
Judge DYK.
RADER, Circuit Judge.
Richelle Pafford (Pafford) alleges that her DTaP, MMR and OPV vaccinations
resulted in the onset of systemic Juvenile Rheumatoid Arthritis.1 Pafford v. Sec’y Of
Health & Human Servs., 2004 WL 1717359 (Ct. Fed. Cl. 2004) (Trial Court Decision).
Because the Special Master correctly interpreted and applied the relevant statutory test
for proving causation in off-table cases, this court affirms.
1 DTaP stands for diphtheria, tetanus (commonly known as lockjaw), and pertussis
(commonly known as German measles.) OPV stands for oral poliovirus vaccine.

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I
On March 24, 1998, Pafford received a series of vaccinations from her doctor,
Dr. Jay Schmidt (Dr. Schmidt). Trial Court Decision, 2004 WL 1717359, at *1. The
vaccinations administered by Dr. Schmidt during this office visit included a DTaP
vaccination, Pafford’s fourth OPV vaccination, and a second MMR vaccination. Id.
Pafford had received routine childhood immunizations prior to this. Both her first and
second DTP, OPV, and Hib vaccinations were normal.2 Id. However, she developed a
faint maculopapular rash approximately seventeen days after receiving her third DTP
and OPV vaccinations and her first MMR vaccination. Id.
Earlier that month, on March 5, 1998, Dr. Schmidt had treated Pafford for a cold
and diarrhea. Approximately one week later, on March 12, 1998, Pafford was seen by
Dr. Schmidt for inflamed tonsils with white patches on them and a fever of 101-102
degrees Fahrenheit. Id. She tested negative for strep. Id. At her March 24, 1998 visit,
Dr. Schmidt examined Pafford and noted that the tonsillitis had cleared. Id. As was the
case throughout her early childhood years, Dr. Schmidt concluded that Pafford was
showing normal growth and development without any unusual medical problems. Id.
On April 4, 1998, Pafford developed a fever and complained of neck pain. Id.
The fever resolved itself, but the neck pain continued. Id. Dr. Schmidt saw Pafford on
April 7, 1998 for her neck pain. Id. By that time, she had developed a diffuse, pink,
macular rash, whitish spots on her tongue. Id. She also complained of limb pain. Id.
Dr. Schmidt diagnosed her with a vaccine-induced rash and recommended that she
avoid exposure to others for five days. Id. On April 13, 1998, Pafford was taken to a
2 DPT is an older version of the DTaP vaccination. Hib stands for Haemophilus
Influenzae Type b vaccine.
05-5106 2

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local hospital emergency room with a fever, vomiting, pain on being touched and a rash
on her hands, legs, chest, and upper abdominal area. Id. at *2. The hospital doctor, Dr.
Bell, noted that “[t]he rash was very viral in character and I did not feel it was related to
her immunizations but suggested a CBC to see if it supported the viral picture.” Id.
Pafford was admitted and her symptoms quickly dissipated. Id. She tested positive for
a bacterial infection known as “mycoplasma” which Dr. Bell determined to be the cause
of Pafford’s symptoms. Id. She was released from the hospital the next day because
her rash and fever had disappeared. Id. On April 20, 1998, Dr. Bell saw Pafford for a
recurrence of her symptoms. Dr. Bell diagnosed Pafford with systemic onset Juvenile
Rheumatoid Arthritis, also known as Still’s disease. Id.
Pafford’s parents, on behalf of Pafford, brought a claim under the National
Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-1 to 34, in the Court of Federal
Claims. They alleged that their daughter’s development of Still’s disease was a result of
the vaccinations she received on March 24, 1998. Id. at *1. On July 16, 2004, Special
Master Richard Abell issued a decision denying Pafford’s claim. Id. Special Master
Abell determined that a vaccine can cause Still’s disease but that Pafford had not
sufficiently demonstrated that in her case the vaccine did cause the development of
Still’s disease. Id.
Following an appeal, Court of Federal Claims Judge Lawrence J. Block issued an
opinion sustaining the Special Master’s decision. Pafford v. HHS, 64 Fed. Cl. 19
(2005). Pafford filed a motion for reconsideration alleging “legal error with regard to
standards of proof and the allocation of burdens” which was denied on March 8, 2005.
05-5106 3

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II.
This court reviews the United States Court of Federal Claims’ review of the
Special Master’s decision without deference. Hines v. Sec’y of Health & Human Servs.,
940 F.2d 1518, 1523-24 (Fed. Cir. 1991). Thus, this court examines the Special
Master’s legal determinations under a “not in accordance with law” standard and factual
determinations under an “arbitrary and capricious” standard. Munn v. Sec’y of Health &
Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
Generally a petitioner can obtain compensation under the vaccine injury
program in two ways. See id. at 865. In a “table” case, the petitioner has an initial
burden to prove an injury listed in the Vaccine Injury Table within the prescribed time
period under the requirements of 42 U.S.C. § 300aa-14(a). See Capizzano v. Sec’y of
Health & Human Servs., 440 F.3d 1317, 1319 (Fed. Cir. 2006) (citations omitted).
Upon satisfying this initial burden, the petitioner earns a presumption of causation. At
that point, the burden shifts to the respondent to prove that a factor unrelated to the
vaccination actually caused the illness, disability, injury, or condition. 42 U.S.C.
§§ 300aa-13(a)(1)(A),(B).
The other avenue for compensation does not involve the presumption of
causation conferred by the table. In an “off-table” case (also known as a “causation-in-
fact” claim), the petitioner cannot obtain a presumption of causation. Rather, the
petitioner in an off-table case has the burden to prove the vaccination in question
“caused” the illness, disability, injury, or condition. 42 U.S.C. §§ 300aa-13(a)(1),
-11(c)(1)(C)(ii)(I). Pafford does not allege she suffered a table injury. Thus, Pafford
must prove causation-in-fact or that the vaccine was actually the cause of her injuries.
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Under this court’s precedent, Pafford must prove by preponderant evidence both
that her vaccinations were a substantial factor in causing the illness, disability, injury or
condition and that the harm would not have occurred in the absence of the vaccination.
Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999)
(“We adopt the Restatement rule for purposes of determining vaccine injury, that an
action is the ‘legal cause’ of harm if that action is a ‘substantial factor’ in bringing about
the harm, and that the harm would not have occurred but for the action.”). This court
recently articulated an alternative three-part test. To show causation in fact, the
petitioner must show:
(1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and (3) . . . a proximate temporal
relationship between the vaccination and injury.
Capizzano, 440 F.3d at 1324 (citing Althen v. Sec’y of Health & Human Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005)). Of course, as noted in Shyface, these prongs must
cumulatively show that the vaccination was a “but-for” cause of the harm, rather than
just an insubstantial contributor in, or one among several possible causes of, the harm.
The Special Master applied the tests of Althen and Shyface correctly in this
case. Specifically, the Special Master indicated:
First, a petitioner must provide a reputable medical theory causally
connecting the vaccination and the injury. In fine, can [the] vaccine(s) at
issue cause the type of injury alleged? Second, a petitioner must also
prove that the vaccine actually caused the alleged symptoms in her
particular case.
Trial Court Decision, 2004 WL 1717359, at *4 (emphasis in original). The first prong of
the Special Master’s test is identical to the first prong of the Althen test. Capizzano, 440
F.3d at 1324 (citing Althen, 418 F.3d at 1278). The Special Master’s inquiry also gave
05-5106 5

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effect to the “logical sequence of cause and effect” at the heart of the second prong of
the Althen test. Trial Court Decision, 2004 WL 1717359, at *6 (discussing Dr. Levin’s
testimony linking Pafford’s March 1998 vaccinations to the onset of Still’s disease).
Most importantly, the second prong of the Special Master’s test in this case restates
correctly that the petitioner must show that the vaccine was the “but for” cause of the
harm according to Shyface, or in other words, that the vaccine was the “reason for the
injury” as stated in the second prong of the Althen test. Finally, the Special Master also
required proof of a proximate temporal relationship between Pafford’s vaccinations and
the onset of Still’s disease commensurate with the third prong of the Althen test.
Trial Court Decision, 2004 WL 1717359, at *9 (“The link missing from Petitioner’s
argument . . . was the lack of any defined time period in which one would expect to see
the onset of Still’s disease subsequent to a triggering event.”). Thus, this court
perceives no significant difference between the Special Master’s test and that
established by this court in Althen and Shyface.
III.
This court turns next to the evidence of record on causation-in-fact. Notably, the
causation evidence of record consists primarily of testimony from two of Pafford’s
experts, Drs. Levin and Geier, and scientific literature on which their testimony was
based. As discussed below, this court finds it was not arbitrary and capricious for the
Special Master to conclude on this record that Pafford did not prove causation by
preponderant evidence.
Applying the causation test to the facts before the court, the Special Master
determined that Pafford proved only one of the two prongs of his test by preponderant
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evidence. Specifically, the Special Master noted, while “it is biologically plausible that
one or more of the vaccinations at issue could cause the onset of Still’s disease[,]” Trial
Court Decision, 2004 WL 1717359, at *5, Pafford did not prove that the vaccinations
were a but-for cause of her contracting Still’s disease (i.e., Pafford failed to satisfy the
“but-for” prong of the Shyface test), id. at *9. The Special Master was particularly
troubled by the lack of evidence demonstrating “any defined time period in which one
would expect to see the onset of Still’s disease subsequent to a triggering event.” Id.
To the Special Master, the absence of temporal linkage evidence prevented him
from finding that a vaccination was the reason for the injury rather than other
contemporaneous events unrelated to the vaccinations. Id. at *7 (“[A]bsent an
appropriate time frame, the Court cannot find the mere temporal proximity of the
vaccination and injury dispositive.”). These contemporaneous events included: (1) a
positive test for mycoplasma (a type of bacteria); (2) x-rays showing a thickening of the
sinus membrane consistent with a sinus infection; (3) an earlier bout of tonsillitis; and
(4) an earlier cold accompanied by diarrhea. Id. at *8. Thus, according to the
Special Master, Pafford did not prove by preponderant evidence that one or more of her
vaccinations were a “but-for” cause of her contracting Still’s disease.
On appeal, Pafford argues “[t]he special master placed an untoward and legally
impermissible burden on petitioners” as part of the but-for inquiry to prove it was the
vaccinations rather than the other contemporaneous events that triggered her Still’s
disease. Brief for Pafford at 54, Pafford v. Sec’y of Health & Human Servs., No. 05-
5106 (Fed. Cir. 2006) (Petitioner’s Brief); see Trial Court Decision, 2004 WL 1717359,
at *4 (“Ruling out other potential causes is an essential element but does not itself
05-5106 7

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establish causation.”). Pafford argues that “[t]his is contrary to the express terms of the
statute, whereby § 300aa-13 (a)(1)(B) contemplates the grant of compensation unless
alternate causation by known factors is shown ‘by a preponderance.’” Petitioner’s Brief
at 54 (emphasis in original). Pafford relies primarily on two of this court’s cases,
Shyface and Grant (as interpreted by Shyface) for the proposition that a petitioner need
not rule out alternative causes in proving actual causation.
Contrary to Pafford’s reading, Shyface and Grant do not stand for this premise.
Shyface was a vaccine injury case involving an infant’s April 1, 1993 DPT vaccination.3
Shyface v. Sec’y of Health & Human Servs., 1997 WL 829404, at *1 (Ct. Fed. Cl.
1997), rev’d, 165 F.3d 1344 (Fed. Cir. 1999). Four days after inoculation, the infant
was taken to a hospital with a fever hovering between 109 and 110° F; tragically the
infant died from the fever the same day. Id. at *2. Subsequent tests revealed the
presence of a bacterial infection that could not be ruled out as the cause of death. Id.
Thus, at trial, petitioners’ expert theorized the DPT vaccination “caused” the infant’s
fever, which was then significantly exacerbated by the infection. Id. at *5. In other
words, petitioners’ expert argued there were two “but-for” causes, the vaccination and
the infection, each of the “but-for” causes being a substantial factor in the infant’s
death. When presented with this theory, the Special Master found preponderant
evidence linking the DPT vaccination to the infant’s death, but still rejected petitioners’
claim because “it is impossible to know with any degree of confidence, which source is
the predominant cause of death.” Id. at *8.
3 DPT is an older version of the DTaP vaccination. This vaccination is
given for the prevention of diphtheria, pertussis, and tetanus.
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On appeal, this court reversed. Shyface, 165 F.3d at 1353. This court held that,
in order to establish a prima facie case, the petitioners had to show “that the DPT
vaccine was both a but-for cause of and a substantial factor in [the infant’s] death.” Id.
The court went on to explain that, while the vaccination must be a “substantial factor” in
the infant’s death, it need not be the sole factor or even the predominant factor. Id. at
1352-53. Thus, the court reversed the Special Master’s decision in favor of
respondent; the Special Master should have awarded compensation to the petitioners
who had proven the DPT vaccine was both a but-for cause of and a substantial factor
in the infant’s death. Id. at 1353.
Unlike Shyface, the petitioner here never established that the vaccinations were
a but-for cause of her contracting Still’s disease. Thus, this case does not feature
several “but-for” causes, one of which is a vaccination. Rather, the Special Master
concluded he was unable to tell whether any of the vaccinations made any contribution
to her contracting Still’s disease due, in part, to the absence of “evidence indicating an
appropriate time frame in which Still’s disease will manifest subsequent to a triggering
event.” Trial Court Decision, 2004 WL 1717359, at *7. “Without such a defined time
period, the link between the vaccinations and the injury is tenuous.” Id. at *9. As noted
earlier, this reasoning applies properly the tests of Althen and Shyface.
Evidence demonstrating petitioner’s injury occurred within a medically
acceptable time frame bolsters a link between the injury alleged and the vaccination at
issue under the “but-for” prong of the causation analysis. See Capizzano, 440 F.3d at
1326 (finding medical opinions that explain how a vaccine can cause the injury alleged
coupled with evidence demonstrating a close temporal relationship “are quite
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probative” in proving actual causation). 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. In contrast, if symptoms
normally first occur ten days after inoculation and petitioner’s symptoms do, in fact,
occur within this period, then the likelihood increases that the vaccination is at least a
factor. Strong temporal evidence is even more important in cases involving
contemporaneous events other than the vaccination, because the presence of multiple
potential causative agents makes it difficult to attribute “but-for” causation to the
vaccination. After all, credible medical expertise may postulate that any of the other
contemporaneous events may have been the sole cause of the injury. Thus, it was
entirely proper for the Special Master to require Pafford to prove but-for causation,
including some showing of temporal relationship between the vaccination(s) and the
onset of injury.
Moreover, the Special Master’s requirement for strong temporal evidence is
consistent with the third prong of the Althen test: demonstrating a proximate temporal
relationship between the vaccination and the injury. See Althen, 418 F.3d at 1278.
Again, without some evidence of temporal linkage, the vaccination might receive blame
for events that occur weeks, months, or years outside of the time in which scientific or
epidemiological evidence would expect an onset of harm.
Turning to the evidence of record, neither of Pafford’s two experts, Drs. Levin
and Geier, provided sufficient evidence for the Special Master to conclude the onset of
Still’s disease occurred within the medically acceptable time frame. Dr. Levin explained
that the DTaP, MMR and OPV vaccines can, in some individuals, trigger an
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autoimmune inflammatory disorder that causes the release of cytokines,4 which in turn
cause the symptoms of Still’s disease. Trial Court Decision, 2004 WL 1717359, at *5.
Dr. Levin did not, however, provide any evidence about a medically acceptable time
frame for the onset of the disease following the vaccination. Transcript of Record at
172-173, Pafford v. Sec’y of Health & Human Servs., No. 01-165V (Ct. Fed. Cl. 2004)
(Trial Transcripts) (emphasis added). Dr. Levin also did not discuss in detail the other
contemporaneous events unrelated to the vaccinations. Thus, the Special Master
properly concluded, under our arbitrary and capricious standard of review, that Dr.
Levin’s testimony standing alone was not sufficient to prove the medically acceptable
time frame or to link the onset of Still’s disease to the vaccinations in this case.
In addition to Dr. Levin, Dr. Geier sought to provide testimony on this point.
Specifically, Dr. Geier testified about the medically acceptable time frame for arthralgia
episodes and joint syndromes generally. Trial Transcripts at 39-40; Petitioner’s Brief at
10. The Special Master found Dr. Geier’s testimony (and the scientific literature on
which his testimony was based) insufficient for at least two reasons. In the first place,
the Special Master noted correctly that evidence about the temporal relationship for
arthralgia episodes and joint syndromes in general does not show the specific temporal
relationship for Still’s disease. Trial Court Decision, 2004 WL 1717359, at *7 n.42. The
Special Master also questioned Dr. Geier’s qualifications because he is not certified in
the areas of rheumatology, pathology, or immunology. Id. at *1 n.2. Notably, this court
accords great deference to a Special Master’s determination on the probative value of
4 Cytokine: “a generic term for non-antibody proteins released by one cell
population on contact with a specific antigen, which act as intercellular mediators, as in
the generation of an immune response.” Trial Court Decision, 2004 WL 1717359, at *5
n. 29.
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evidence and the credibility of witnesses. See Lampe v. Sec’y of Health & Human
Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (noting that the probative value of the
evidence and the credibility of the witnesses are matters within the purview of the fact
finder). On this record, the court cannot discern any reversible error in the Special
Master’s findings that Dr. Geier did not prove the temporal relationship between Still’s
disease and the vaccination.
Without credible testimony from either Dr. Geier or Dr. Levin on the medically
acceptable time frame, the record contains little evidence linking Still’s disease to the
vaccinations in this particular case and leaves Pafford without adequate evidence to
show “but-for” causation under this court’s causation standards. See Trial Court
Decision, 2004 WL 1717359, at *7 (“Petitioners provide no objective evidence
indicating an appropriate time frame in which Still’s disease will manifest subsequent to
a triggering event.”). Without a link between Still’s disease and the vaccinations, the
Special Master properly introduced the presence of the other unrelated
contemporaneous events as just as likely to have been the triggering event as the
vaccinations. Id. at *8. Hence, petitioner did not show it was more likely that the
vaccinations were a but-for cause of and a substantial factor in her contracting Still’s
disease.
IV.
In her final argument, Pafford alleges the Special Master committed a
Due Process violation by raising the medically accepted time frame issue sue sponte at
the close of trial, without providing her a full and fair opportunity to present evidence on
this issue. The record, however, shows that the petitioner knew of the medically
05-5106 12

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accepted time frame issue well before the end of the trial and chose to rely on
Dr. Geier to provide the required evidence. Response to Order to Show Cause &
Motion for Inclusion in “Omnibus” Rubella Arthritis Cases at 1-2, Pafford v. Sec’y of
Health & Human Servs., No. 01-165V (Ct. Fed. Cl. 2001) (asserting “the onset of Still’s
disease appears to fit within the bounds of biological plausibility and medically
significant temporal relationship to vaccination” in view of literature associating the
condition with rubella vaccine); Petitioner’s Brief at 30 (“Petitioners’ had determined
the[y] would rely on Dr. Geier to address . . . the ‘time frame’ element . . . .”). While Dr.
Geier did not supply sufficient admissible evidence to satisfy this critical portion of the
causation test, Pafford’s admitted reliance on Dr. Geier in this regard impeaches her
Due Process argument.
V.
In summary, the Special Master did not err in requiring specific evidence about a
medically acceptable time frame linking the onset of Still’s disease to the vaccinations
at issue. In the absence of such evidence, the court cannot say the Special Master’s
finding that Pafford failed to prove causation by preponderant evidence was arbitrary
and capricious. Thus, this court affirms.
COSTS
Each party shall bear its own costs.
AFFIRMED
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United States Court of Appeals for the Federal Circuit
05-5106
LISA ANN PAFFORD
and RICHARD LEON PAFFORD,
Parents and Next Friends of
Richelle Lorae Pafford, a minor,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent-Appellee.
DYK, Circuit Judge, dissenting.
The majority today holds that petitioners seeking compensation under the
National Childhood Vaccine Injury Compensation Program (the “Vaccine Act”) must
establish, as essential elements of a prima facie showing of causation in off-Table
cases, both (1) a “proximate temporal relationship between [the] vaccinations and the
onset of [injury],” Ante at 6; and (2) an absence of “alternative causes” of the injury.
Ante at 8. While there are some unfortunate dicta in our cases that might support the
majority’s approach, our earlier holdings and the statute itself are to the contrary. The
majority’s interpretation of the Vaccine Act approves the efforts of the Special Masters
to impose unwarranted bright-line tests for causation under the statute. I respectfully
dissent.

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I
This case involves the five-prong test for causation in off-Table cases announced
by the Chief Special Master in Stevens v. Secretary of the Department of Health and
Human Services, No. 99-594V, 2001 WL 387418 (Ct. Cl. Spec. Mstr. Mar. 30, 2001).
That test required petitioners to establish: (1) medical plausibility; (2) confirmation of
medical plausibility from the medical community and literature; (3) an injury recognized
by the medical plausibility evidence and literature; (4) a medically-acceptable temporal
relationship between the vaccination and the onset of the alleged injury; and (5) the
elimination of other causes. Id. at *23-*26. We have already held that prongs (2) and
(3) of this test are inconsistent with the statute. Althen v. Sec’y of Health & Human
Servs., 418 F.3d 1274, 1279-81 (Fed. Cir. 2005). We have also held invalid a sixth
Special-Master-created rule requiring petitioners, in order to demonstrate causation in
fact in off-Table cases, to supply at least one of four types of evidence: “epidemiologic
studies; rechallenge; presence of pathological markers or genetic predisposition; or
general acceptance [of the causal relationship] in the scientific and medical
communities . . . .” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1323
(Fed. Cir. 2006). This case for the first time presents the issue of the validity of prongs
(4) and (5) of the Stevens test. The Special Master in this case rejected the petitioners’
claim based on these two requirements. See Pafford v. Sec’y of Health & Human
Servs., No. 01-0165V, 2004 WL 1717359, at *7, *9 (Ct. Cl. Spec. Mstr. July 16, 2004).
II
Here, the petitioners put on substantial evidence of causation. Their expert, Dr.
Levin, testified that it is generally accepted in the medical community that “the
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symptoms of Still’s disease are caused by cytokine expression.” Levin and the
government’s expert agreed that “vaccines induce cytokine production.” See id. at *5.
As to Richie Pafford’s case, Levin stated that “’immune activation caused by DPT
vaccinations is in turn caused by the release of the very cytokines that are elevated in
Still’s disease,’” and that although “the medical field had yet to develop testing
sophisticated enough to identify specific cytokines” in patients, “indirect tests performed
[on Richie] . . . correlate[d] with the clinical symptomatology.” Id. at *6. Levin concluded
that “‘the only factor that seems associated with the development of this disease
process [in Richie Pafford] is the vaccination.’” Id. The government did not introduce
evidence to establish causation by any factor unrelated to the vaccinations. Id. at *8.
Acknowledging that it was a close case, the Special Master “painstakingly looked
for the feather in Petitioners’ argument that would tip the scales” as to causation in fact,
but concluded that “the lack of any defined time period in which one would expect to see
the onset of Still’s disease subsequent to a triggering event,” and the petitioners’ failure
to rule out causation by other “contemporaneous events,” required denial of
compensation. See id. at *9. The majority holds that this was proper.
III
Prong (4) of the Stevens test requires evidence of “a medically acceptable
temporal relationship between the vaccination and the onset of the alleged injury” which
“is defined through peer-reviewed literature . . . .” Stevens, 2001 WL 387418, at *25.
To meet this requirement, “petitioners must satisfactorily prove that the onset occurred
within a time frame deemed medically appropriate according to the scientific or medical
evidence. . . .” Id. The Chief Special Master relied on no decision from this court for the
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requirement, but rather on other Special Master decisions and reports issued by the
National Academy of Sciences’ Institute of Medicine (“IOM”). See id. at *25 n.78, *26 &
n.79.
The majority states that “the Special Master also required proof of a proximate
temporal relationship between Pafford’s vaccinations and the onset of Still’s disease
commensurate with the third prong of the Althen test.” Ante, at 6. The majority relies
on the statement in Althen, 418 F.3d at 1281, that the “medically acceptable temporal
relationship” requirement “is merely a recitation of this court’s well-established
precedent.” The well-established precedent to which Althen was referring was
apparently Lampe v. Secretary of Health and Human Services, 219 F.3d 1357 (Fed. Cir.
2000), Shyface v. Secretary of Health & Human Services, 165 F.3d 1344 (Fed. Cir.
1999), Hodges v. Secretary of Health & Human Services, 9 F.3d 958 (Fed. Cir. 1993),
and Grant v. Secretary of Health & Human Services, 956 F.2d 1144, 1149 (Fed. Cir.
1992). These cases were cited in the Althen opinion.
In fact, the precedent cited in Althen merely stands for the proposition that the
temporal relationship between vaccination and injury may be a pertinent factor to
consider in determining causation. In Lampe, for example, we stated only that “[t]he
passage of time between an event and the consequences that are alleged to flow from it
is often significant,” not that a medically significant time interval is required. 219 F.3d at
1366. And in Hodges, we did not suggest that evidence of a temporal relationship is
required -- we held only that where the petitioners failed to prove a Table injury, literal
temporal proximity to vaccination and the absence of other possible causes, alone,
were insufficient to establish causation in fact for an off-Table injury. See 9 F.3d at 960-
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61. In Shyface, we addressed the standard for proving causation in off-Table cases in
great detail and never once suggested a “medically established temporal relationship”
requirement. Instead, we held that the petitioner must prove “that the vaccine was not
only a but-for cause of the injury but also a substantial factor in bringing about the
injury.” 165 F.3d at 1352. Nor did we suggest in Shyface that a temporal relationship is
necessary to establish either the but-for or substantial factor elements of causation.
See id. at 1352-53.
Significantly, in Grant, we rejected a temporal requirement. There, the petitioner
sought compensation for encephalopathy-induced infantile spasms that began 10 days
after a Quadrigen vaccination.1 Grant, 956 F.2d at 1146-47. Because the spasms
occurred outside the Table time period (3 days, 42 U.S.C. § 300aa-14(a)), the petitioner
was required to establish causation in fact. The Special Master nevertheless found
causation, relying on “evidence that pertussis as part of the Quadrigen vaccine has a
heightened potential to cause . . . exactly the symptoms that occurred to [the petitioner]
. . . .” Id. at 1149. On appeal, we rejected the government’s argument, based on
epidemiological studies, that the “lack of statistical proof [of an association between
DTP vaccine and infantile spasms 10 days later] . . . . is dispositive on the issue of
causation.” Br. of Secretary of Health & Human Servs., Grant, 956 F.2d 1144, at 15-17;
see Grant, 956 F.2d at 1148. We concluded that “[t]hese epidemiological studies . . .
are not dispositive of the actual causation question in this case.” Grant, 956 F.2d at
1149. We affirmed the award of compensation, observing that:
1 The Quadrigen vaccine combined diphtheria, pertussis, tetanus and polio
vaccines in a single administration. Grant, 956 F.2d at 1145.
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[T]he Chief Special Master did not rely on expert testimony based on
temporal association and studies of less direct relevance. Instead, the
Chief Special Master relied on a preponderance of relevant scientific and
medical evidence about the particular nature of Quadrigen. This court
discerns nothing arbitrary, capricious, or unlawful in that reliance.
Id.
In rejecting a temporal requirement for off-Table cases, Grant was entirely
consistent with the statute. Indeed, the “medically acceptable temporal relationship”
requirement is plainly contrary to the Vaccine Act. As we have repeatedly recognized,
the purpose of the Vaccine Injury Table was to afford petitioners a presumption of
causation for particular types of injury for which there is a medically accepted temporal
relationship with vaccination.2 Every Table injury has an associated time period. See
42 U.S.C. § 300aa-14(a) (2000). Congress explained that scientific research might
establish additional temporal relationships which, if found, would result in amendments
to the time periods specified in the table:
The Committee anticipates that the research on vaccine injury and
vaccine safety now ongoing and mandated by this legislation will soon
provide more definitive information about the incidence of vaccine injury
and that, when such information is available, the Secretary or the Advisory
Commission on Childhood Vaccines . . . may propose to revise the
Table . . . .
2 See, e.g., Hodges, 9 F.3d at 961 (“Bring the case within the timetable and
specifications of a Table Injury and the statute does the heavy lifting – causation is
conclusively presumed.”); Grant, 956 F.2d at 1147 (“The Vaccine Table, in effect,
determines by law that the temporal association of certain injuries with the vaccination
suffices to show causation.”); Cucuras v. Sec’y of Health & Human Servs., 993 F.2d
1525, 1527-28 (Fed. Cir. 1993) (quoting Grant, 956 F.2d at 1147). Notably, the Chief
Special Master in Stevens relied on the Secretary’s 1995 explanation of the measles,
mumps, and rubella vaccine/encephalopathy Table timeframe as an example of a
“medically accepted temporal relationship.” See 2001 WL 387418, at *25 (citing 60
Fed. Reg. 7678, 7692).
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H.R. Rep. 99-908, at 18 (1986), as reprinted in 1986 U.S.C.C.A.N. 6344, 6359. Thus
the Vaccine Act provides that the Secretary of Health and Human Services may by
regulation “add to, or delete from, the list of injuries . . . or may change the time periods
for the first symptom or manifestation of the onset . . . of any such injury . . .” in the
Table. 42 U.S.C. § 300aa-14(c)(3) (2000); see 42 U.S.C. § 300aa-14(c)(1).
In 1995, for example,3 the Secretary changed the Table time interval between
administration of pertussis vaccines and “anaphylaxis or anaphylactic shock” from 24
hours to 4 hours, explaining that “the pediatric literature is clear in stating that severe
anaphylactic reactions occur immediately with antigen exposure and rarely show their
first manifestation after 4 hours.” 60 Fed. Reg. 7678, 7686 (Feb. 8, 1995). The
Secretary also changed the Table time interval between administration of the measles,
mumps, and rubella vaccine and the onset of encephalopathy from 15 days to “5 to 15
days,” explaining that “[s]ince viral replication is required for a viral vaccine-associated
encephalopathy, a window for the expected time of onset is appropriate. . . . [and] the
1991 [National Vaccine Advisory Committee] Subcommittee felt there was strong
support in the literature to narrow the timeframe as above.” Id. at 7692.
However, scientific research on vaccine-related injuries remains incomplete; thus
it is not always possible to identify the “medically accepted temporal relationship.” In a
2000 report on the progress of the Vaccine Act, Congress noted that “[o]f the 76
adverse events IOM reviewed [in 1991 and 1994] for a causal relationship [with
vaccination], 50 (66 percent) had no or inadequate research.” H.R. Rep. 106-997, at 5
(2000).
3 The Table was also revised in 1997 and 2002, 62 Fed. Reg. 7685 (Feb.
20, 1997); 67 Fed. Reg. 48558 (July 25, 2002), and is codified at 42 C.F.R. § 100.3.
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In recognition of the uncertain state of scientific knowledge, the statute provides
what is known as an off-Table remedy, allowing recovery where the petitioner can
establish that the injury “was caused by a vaccine” listed in the Table, even though the
particular injury is not listed in the Table. 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii)(I) & (II)
(2000). Another important purpose of allowing recovery for off-Table injuries was to
allow a petitioner to make a claim for an injury listed in the Table where the injury was
not manifested during the medically accepted time frame set forth in the Table.4 The
Vaccine Act specifically authorizes compensation for petitioners who “sustained . . . any
illness, disability, injury, or condition set forth in the Vaccine Injury Table the first
symptom or manifestation of the onset of . . . which did not occur within the time period
set forth in the Table but which was caused by a vaccine referred to in subparagraph
(A).” 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(II) (2000) (emphasis added). Thus the statute
clearly contemplates that causation in fact may be established in off-Table cases
without showing the “medically accepted temporal relationship” listed in the Table.5
This purpose would be directly thwarted if proof of a medically accepted
timeframe were required to show causation in off-Table cases. But that is exactly what
the majority requires here. In this case, there was substantial evidence regarding the
biological mechanism of causation, even though the experts did not identify a medically
accepted temporal relationship. See Pafford, 2004 WL 1717359, at *5-*6. Under the
4 The Secretary, in reducing the pertussis vaccines/anaphylaxis Table time
interval from 24 hours to 4 hours, noted that “[p]etitioners may receive compensation
under the [Vaccine Act] if they prove their injury was caused by the vaccination, even if
onset was after the 4 hours specified in the Table.” 60 Fed. Reg. at 7678.
5 Congress made clear that it did “not intend . . . to suggest that variance
from the Table should act as a presumption against the petitioner but rather only that
such a petitioner is not to be deemed eligible for compensation without further showings
of causation.” H.R. Rep. 99-908, at 15.
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majority’s holding, any petitioner who fails to establish a medically accepted temporal
relationship automatically lacks an essential element of their prima facie case for
causation in fact. That holding is inconsistent with the clear provisions of the statute
and our prior holdings interpreting it.
III
The Special Master here concluded that “[r]uling out other potential causes is an
essential element” of the petitioner’s case. Pafford, 2004 WL 1717359, at *4. The
Court of Federal Claims, after reviewing our cases and the Chief Special Master’s
decision in Stevens, concluded that in off-Table cases, the “initial burden of proof
regarding alternative causation [is] on the petitioner . . . as part of establishing a prima
facie case of causation-in-fact.” Pafford v. Sec’y of Health & Human Servs., 64 Fed. Cl.
19, 35 (2005).6 The majority, in sustaining the Special Master’s decision here, appears
to agree. As with the temporal relationship prong, there is at least a fragment of dictum
supporting this view. See Munn v. Sec’y of Health & Human Services, 970 F.2d 863,
865 (Fed. Cir. 1992) (“The claimant must prove by a preponderance of the evidence
6 See also Pafford, 64 Fed. Cl. at 30 (“The Federal Circuit has instructed
that an actual-causation vaccine petitioner ‘must prove by a preponderance of the
evidence that the vaccine, and not some other agent, was the actual case of the injury.’
Munn, 970 F.2d at 863 (emphasis added). This would seem to engender the need for a
petitioner to eliminate other possible causes of the condition (other than the vaccine)
that exist in the record.”); id. (“. . . petitioner[] must eliminate other reasonably possible
causes that exist in the record to meet its burden of establishing a prima facie case for
causation-in-fact.”); id. at 35 (“[T]he overwhelming weight of authority in this Circuit is
consistent with traditional notions of tort law that place an initial burden of proof
regarding alternative causation on the petitioner . . . as part of establishing a prima facie
case of causation-in-fact.”); id. at 36 (“[I]n establishing his prima facie case of
entitlement, the petitioner must discount other potential causal factors that the record
reveals, because the required ‘substantial factor’ analysis requires as much.”); id. at 36
(“. . . it was incumbent upon [the petitioners] to discount the role of these potential
alternatives in order to prove that the vaccines were, more likely than not, the cause of
Richelle’s Still’s disease.”).
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that the vaccine, and not some other agent, was the actual cause of the injury.”). Since
the dictum in Munn, however, we have unequivocally held that, under section 300aa-
13(a)(1)(B), the government bears the burden of proof regarding causation by “factors
unrelated” to vaccination.
Section 300aa-13(a)(1) of the Vaccine Act provides, in pertinent part:
Compensation shall be awarded under the Program to a petitioner if the
special master or court finds on the record as a whole –
(A) that the petitioner has demonstrated by a preponderance of the
evidence [a Table injury or causation in fact], and
(B) that there is not a preponderance of the evidence that the illness,
disability, injury, condition, or death described in the petition is due to
factors unrelated to the administration of the vaccine described in the
petition.
42 U.S.C. § 300aa-13(a)(1) (2000) (emphasis added). As we have recognized, the
plain language and structure of this provision establish that the petitioner’s burden to
make a prima facie showing of either presumptive or actual causation set out in section
300aa-13(a)(1)(A) does not include the burden of proof regarding “factors unrelated” to
vaccination set out in section 300aa-13(a)(1)(B) – “[t]hese are two separate inquiries
under the statute.” Grant, 956 F.2d at 1149 (“The Vaccine Act expressly separates the
inquiry for alternative etiologies from the inquiry for causation.”).
We have repeatedly held that the separate burden of proof regarding “factors
unrelated” to vaccination belongs to the government in both Table and off-Table cases.
See, e.g., Jay v. Sec’y of Health & Human Servs., 998 F.2d 979, 984 (Fed. Cir. 1993)
(section 300aa-13(a)(1)(B) requires a “statutorily separate inquiry . . . [as to] whether an
alternative causation has been proved by [the government].” (emphasis added)). In
Knudsen v. Secretary of Health & Human Services, 35 F.3d 543 (Fed. Cir. 1994), a
Table case, the petitioners argued that the government failed to satisfy its burden of
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proof for its argument that the injury was caused by a viral infection rather than the
vaccine. In defining the government’s burden under section 300aa-13(a)(1)(B), we held
that “[t]he government was required not only to prove the existence of an infection (here
viral), but also to prove by a preponderance of the evidence that the particular viral
infection present in the child actually caused the table injury complained of.” Id. at 549.
And in Shyface, an off-Table case, we rejected the government’s argument that the
statute requires the petitioner to establish “’that the vaccine is more likely than any other
factor to have been directly responsible for the injury,’” 165 F.3d at 1349, and concluded
that compensation was warranted because the petitioners made a prima facie showing
of causation and the government “failed to prove that factors unrelated to the vaccine
were principally responsible . . . .” Id. at 1353.
Indeed the Second Restatement of Torts, which we held in Shyface to be
controlling in off-Table cases, 165 F.3d at 1351-52, provides that the defendant bears
the burden of proof on alternate causation. The Restatement describes the prima facie
showing of causation in cases involving more than one possible cause: “[i]f two forces
are actively operating, one because of the actor’s negligence, the other not because of
any misconduct on his part, and each of itself is sufficient to bring about harm to
another, the actor’s negligence may be found to be a substantial factor in bringing it
about.” Restatement (Second) of Torts § 432(2) (1965). “[T]he burden of proof that the
tortious conduct of the defendant has caused the harm to the plaintiff is upon the
plaintiff.” Id. § 433B(1). But in cases involving multiple causes, the Restatement
places the burden on the defendant to prove either “the apportionment” of the harm
among the causes, or that one of the causes other than the defendant’s conduct
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actually caused the entirety of the harm to the plaintiff. Id. §§ 433B(2) & (3). Contrary
to the majority’s view, the same allocation of burdens is required under the Vaccine Act.
IV
In summary, the majority incorrectly holds that petitioners, in order to make a
prima facie case in off-Table cases, must establish a “medically accepted temporal
relationship” between vaccine and injury and eliminate other possible causes of the
injury. In doing so, the majority perpetuates causation requirements imposed on
vaccine petitioners by the Special Masters, whose “role is to assist the courts by judging
the merits of individual claims on a case-by-case basis, not to craft a new legal standard
to be used in causation-in-fact cases.” Althen, 418 F.3d at 1281. This case should be
remanded for adjudication under the correct legal standard.
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