United States Court of Appeals for the Federal Circuit
2009-5128
ROLF HAZLEHURST and ANGELA HAZLEHURST,
parents of WILLIAM YATES HAZLEHURST,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent-Appellee.
Curtis R. Webb, Webb, Webb & Guerry, of Twin Falls, Idaho, argued for petitioners-
appellants.
Lynn E. Ricciardella, Trial Attorney, Torts Branch, Civil Division, United States
Department of Justice, of Washington, DC, argued for respondent-appellee. With her on
the brief were Tony West, Assistant Attorney General, Timothy P. Garren, Director, Mark
W. Rogers, Deputy Director, and Gabrielle M. Fielding, Assistant Director.
Appealed from: United States Court of Federal Claims
Senior Judge John P. Wiese
United States Court of Appeals for the Federal Circuit
2009-5128
ROLF HAZLEHURST and ANGELA HAZLEHURST,
parents of WILLIAM YATES HAZLEHURST,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent-Appellee.
Appeal from the United States Court of Federal Claims
in 03-VV-654, Senior Judge John P. Wiese.
___________________________
DECIDED: May 13, 2010
___________________________
Before NEWMAN and BRYSON, Circuit Judges, and GUILFORD, District Judge. ∗
BRYSON, Circuit Judge.
This is one of a large number of cases involving claims for compensation on
behalf of autistic children whose condition is alleged to have been caused by childhood
vaccinations. In this case, Rolf and Angela Hazlehurst filed a claim for their son, Yates
Hazlehurst, seeking compensation under the National Childhood Vaccine Injury Act of
1986 (“the Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34. The Hazlehursts alleged that
the measles, mumps, and rubella (“MMR”) vaccine, which was administered to Yates
∗
The Honorable Andrew J. Guilford, District Judge, United States District
Court for the Central District of California, sitting by designation.
shortly before his first birthday, caused him to develop regressive autism. A special
master denied the Hazlehursts’ petition, and the Court of Federal Claims affirmed.
Hazlehurst v. Sec’y of Heath & Human Servs., 88 Fed. Cl. 473 (2009). On appeal to
this court, the Hazlehursts argue that the special master improperly relied on certain
evidence that should have been excluded and disregarded other evidence that should
have been considered. We affirm.
I
The Office of Special Masters consolidated this case with several others as part
of what was termed the Omnibus Autism Proceeding, an effort by the Office of Special
Masters to identify and adjudicate certain test cases as a means of addressing the
principal issues in approximately 5,000 autism claims that have been filed under the
Vaccine Act. The objective of the omnibus proceeding was to determine the
relationship, if any, between vaccines and autism spectrum disorders. This case was
considered together with two others, Cedillo v. Secretary of Health and Human
Services, No. 98-916V, and Snyder v. Secretary of Health and Human Services, No. 01-
162V, in one of the groups of test cases. In the Cedillo and Snyder cases, the
petitioners presented a theory of causation based on the combined effect of the MMR
vaccine and vaccines containing thimerosal, a vaccine preservative. The Hazlehursts
initially presented that theory of causation, but in post-hearing briefing they relied on the
theory that Yates’s autism was caused by the MMR vaccine alone. Although each of
the three cases was decided by a different special master, the record in this case
includes all of the general causation evidence admitted in Cedillo and Snyder. The full
record encompasses tens of thousands of pages of medical literature, more than four
2009-5128 2
thousand pages of hearing testimony, and fifty expert reports containing the opinions of
seven experts for the petitioners and eighteen experts for the government.
The evidence at the hearing showed that Yates Hazlehurst was born on February
11, 2000, and developed normally during his first year of life. On February 8, 2001,
three days before his first birthday, Yates received an MMR vaccination. Within a
month after his MMR vaccination, according to his family, Yates became “wild,” “very
hyperactive,” and “out of control.” By the summer of 2001, Yates had lost all meaningful
speech, even though he had previously used words such as “mama,” “please,” and
“thank you.” At about the same time, he developed chronic diarrhea and abdominal
pain. Following a series of evaluations in July 2002, Yates was diagnosed as exhibiting
a pattern of behavior consistent with autism.
In 2003, the Hazlehursts filed a petition for vaccine injury compensation under
the Vaccine Act. The special master summarized their theory of causation as follows:
[P]etitioners assert that the measles component of the MMR vaccine
causes an immune dysfunction that impairs the vaccinee’s ability to clear
the measles virus. Unable to properly clear the measles virus from the
body, the vaccinee experiences measles virus persistence which leads to
chronic inflammation in the gastrointestinal system and, in turn, chronic
inflammation in the brain. Petitioners argue that the inflammation in the
brain causes neurological damage that manifests as autism.
Hazlehurst v. Sec’y of Health & Human Servs., No. 03-654V, 2009 WL 332306, at *86
(Fed. Cl. Feb. 12, 2009). The Hazlehursts acknowledged that the linchpin of their
theory was the discovery of persistent measles virus in certain autistic children who had
received the MMR vaccine. That evidence derived from the research of Dr. Andrew
Wakefield of the Royal Free Hospital in London and his colleagues at the Unigenetics
2009-5128 3
laboratory in Dublin, and the research of Dr. Stephen Walker and his colleagues at the
Wake Forest University School of Medicine.
Dr. Wakefield was the primary proponent of the hypothesis that the MMR vaccine
could cause autism in certain children. His work led to civil litigation against certain
vaccine manufacturers in the United Kingdom (“the UK litigation”). The Unigenetics
laboratory was a for-profit, non-accredited institution that was established to support the
UK litigation by testing children for the presence of measles virus in certain body
tissues. The Unigenetics research, which reported successful use of the polymerase
chain reaction technique (“PCR”) to identify and amplify measles virus genetic material
in the blood and intestinal tissues of autistic children, formed the basis for a 2002 article
co-authored by Dr. Wakefield (the Uhlmann article) on which the Hazlehursts primarily
rely. In addition, the Hazlehursts rely on preliminary research results reported by the
Walker group. In an abstract and poster presentation delivered at the June 2006
International Meeting for Autism Research (“IMFAR”), the Walker group claimed to have
replicated the positive results reported by Unigenetics.
The Hazlehursts’ key witness at their hearing was Yates’s pediatric neurologist,
Dr. Jean-Ronel Corbier. Dr. Corbier relied heavily on the results of the Unigenetics and
Walker studies as support for his opinion that Yates’s February 8, 2001, MMR
vaccination played a substantial role in causing Yates’s autism. Dr. Corbier testified
that those studies suggested that the MMR vaccine may contribute to the development
of regressive autism in children who fit a particular clinical profile, including normal
development prior to receipt of the MMR vaccination, display of symptoms of regressive
2009-5128 4
autism within one to nine months after receipt of the MMR vaccination, and
development of gastrointestinal problems during that period.
The special master also heard testimony from Dr. Karin Hepner and Dr. Arthur
Krigsman, two of the researchers in the Walker group. Drs. Hepner and Krigsman cited
their own work as evidence of the reliability and reproducibility of the Unigenetics test
results. They also stated that the Walker group had confirmed its results through
genetic sequencing. Dr. Krigsman testified that the group had verified, at least for some
samples, that the genetic material identified and amplified by PCR contained the same
nucleotide sequence as the targeted product, i.e., vaccine-strain measles virus.
In response to the petitioners’ evidence concerning the presence of measles
virus in autistic children, the government offered expert testimony and reports from,
among others, Dr. Stephen Bustin, a molecular biologist who had appeared as an
expert in the UK litigation. In connection with the UK proceedings, Dr. Bustin had been
hired by vaccine manufacturers to evaluate the testing methods of the Unigenetics
laboratory. After analyzing Unigenetics’ equipment and notebooks, Dr. Bustin
concluded that the Unigenetics researchers had failed to follow their own standard
operating procedures, had failed to abide by certain standard laboratory practices, and
had failed to comply with standards set forth by the manufacturers of the laboratory
testing equipment, all of which undermined the reliability of the laboratory’s test results.
Dr. Bustin memorialized his conclusions in reports that were filed under seal in the UK
litigation and later released to the government in the Omnibus Autism Proceeding.
Over objection, the government sought to introduce Dr. Bustin’s reports and
testimony regarding the Unigenetics laboratory, which, by that time, had gone out of
2009-5128 5
business. 1 The special master in the Cedillo case provisionally admitted the evidence.
The three special masters in the omnibus proceeding then deferred decision on whether
to rely on that evidence and stated that they would “favorably consider joining in a
request” by the petitioners “for the release of relevant reports” from the UK litigation.
The record remained open for more than a year following the Cedillo hearing to afford
the petitioners sufficient time to present rebuttal evidence, to conduct additional cross-
examination of Dr. Bustin, and to obtain documents from the British court. However,
none of the petitioners recalled Dr. Bustin for further questioning or applied for access to
any of the materials from the UK litigation.
The special master subsequently denied the Hazlehursts’ motion to strike Dr.
Bustin’s reports and testimony. She explained that Dr. Bustin’s evidence was highly
relevant and that fairness had been achieved by affording the petitioners a generous
period of time in which to obtain any additional relevant information.
In her decision on the merits, the special master concluded that the Hazlehursts
had failed to prove that Yates’s MMR vaccination had caused his autism. In a lengthy
opinion, the special master analyzed the evidence of record in detail and addressed
each aspect of the petitioners’ general and case-specific theories of causation. In
particular, the special master found that the Wakefield, Unigenetics, and Walker studies
were flawed or unreliable and that Dr. Corbier’s opinion regarding causation, which was
largely predicated on those studies, was entitled to little weight.
1
The Unigenetics laboratory was closed following the discontinuation of the
UK litigation.
2009-5128 6
The special master found that Dr. Wakefield’s work had been largely discredited
within the scientific community and that none of the studies indicating the presence of
measles virus in autistic children had been successfully replicated by an accredited
laboratory independent of Dr. Wakefield or Unigenetics. In particular, the special
master found that Dr. Wakefield’s early 1990s research on persistent measles infections
was reviewed by the Medical Research Council of the United Kingdom and found to lack
important controls and sufficiently specific reagents for detecting measles virus. She
also found that Dr. Wakefield’s subsequent research was dismissed by the scientific
community as methodologically unsound. In that regard, she noted that 10 of 12 co-
authors on Dr. Wakefield’s controversial 1998 article in the medical journal The Lancet
subsequently retracted their support for the article’s conclusion that there is a potential
causal link between the MMR vaccine and autism.
Relying in part on Dr. Bustin’s testimony and reports, the special master also
found that Unigenetics employed “flawed laboratory practices” that rendered its test
results “scientifically unreliable.” She concluded that the laboratory practices at
Unigenetics differed considerably not only from the standard practices for conducting
PCR testing, but also from the operating procedures established within the laboratory.
For example, the special master cited Dr. Bustin’s testimony that the Unigenetics
researchers (1) tested degraded genetic material rather than discarding it; (2) used
inconsistent procedures to extract and evaluate the genetic material; (3) omitted key
steps necessary to prepare samples for PCR amplification; (4) failed to heed the
equipment manufacturer’s instruction to exclude from analysis the first three cycles of
amplification; and (5) reported positive findings, rather than re-running tests, when
2009-5128 7
duplicate assays showed inconsistent results (one positive and one negative). The
special master also highlighted testimony suggesting the presence of contamination,
including Dr. Bustin’s observation that approximately one-third of the test runs displayed
positive results in the negative controls, which were specifically designed not to contain
any of the targeted genetic material.
The special master further concluded that the unpublished and preliminary
findings of the Walker group should not be accorded significant weight. She observed
that Dr. Hepner had declined to “draw any conclusions about the biological significance”
of the investigators’ findings and had testified that negative controls were not included
with each experimental run. The special master also noted that the petitioners’ experts
based their opinions on the characteristics of the “wild-type” measles virus, as opposed
to the vaccine-strain measles virus, which is far less virulent and replicates poorly in the
human body.
Based on all the evidence of record, the special master concluded that the
Hazlehursts’ causation theory depended on evidence that was discredited, unreliable, or
inapposite. The special master therefore denied the petition for compensation. The
Hazlehursts then appealed to the Court of Federal Claims, which affirmed the special
master’s decision in a comprehensive opinion. The Hazlehursts appealed that decision
to this court.
II
The Hazlehursts argue that the special master improperly relied on Dr. Bustin’s
testimony and reports criticizing the Unigenetics laboratory’s procedures, and that she
failed to consider relevant evidence from Dr. Hepner indicating that the Walker group
2009-5128 8
had verified its test results through genetic sequencing. They urge that those errors
require us to overturn the special master’s ultimate conclusion as to causation.
We review de novo the judgment of the Court of Federal Claims reviewing a
special master’s grant or denial of compensation under the Vaccine Act. Hines v. Sec’y
of Health & Human Servs., 940 F.2d 1518, 1524 (Fed. Cir. 1991); see also Lampe v.
Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000). By statute, the
Court of Federal Claims may set aside the special master’s decision “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). We apply the same standard when reviewing the judgment of the
Court of Federal Claims. Id.
“[W]e do not sit to reweigh the evidence,” Lampe, 219 F.3d at 1363, or to make
credibility determinations, which are “uniquely within the purview of the special master,”
Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993). Our review
pursuant to the Vaccine Act is “uniquely deferential”; we may not second-guess the
special master’s fact-intensive conclusions, particularly where the medical evidence of
causation is in dispute. Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961
(Fed. Cir. 1993). If the special master has considered the relevant evidence of record,
drawn plausible inferences, and articulated a rational basis for the decision, “reversible
error will be extremely difficult to demonstrate.” Hines, 940 F.2d at 1528.
Because Yates Hazlehurst’s injury is not on the Vaccine Injury Table, 42 U.S.C. §
300aa-14, the Hazlehursts cannot avail themselves of the statutory presumption of
2009-5128 9
causation that applies to Table injuries. Moberly v. Sec’y of Health & Human Servs.,
592 F.3d 1315, 1321 (Fed. Cir. 2010). They were therefore required to demonstrate by
a preponderance of the evidence that the MMR vaccine caused Yates’s condition. Id.
A
The Hazlehursts argue that the special master should have excluded Dr. Bustin’s
testimony and reports criticizing Unigenetics’ laboratory practices. They contend that
her consideration of that evidence violated the provision of the Vaccine Rules requiring
evidentiary determinations to be governed by principles of fundamental fairness.
According to the Hazlehursts, the admission of Dr. Bustin’s testimony and reports gave
the government an unfair advantage because the petitioners could not adequately
respond to Dr. Bustin’s criticisms without access to the materials he had examined,
such as Unigenetics’ laboratory equipment and notebooks. Those materials are no
longer in existence or are under seal following the closing of the Unigenetics laboratory
and the termination of the UK litigation. In any event, the petitioners argue, it would
have been prohibitively expensive for the petitioners to have their own experts review
that evidence.
Vaccine Rule 8 provides that “[i]n receiving evidence, the special master will not
be bound by common law or statutory rules of evidence but must consider all relevant
and reliable evidence governed by principles of fundamental fairness to both parties.”
Vaccine R. 8(b)(1) (2009). That rule echoes the statutory requirement that the special
master “shall consider . . . all . . . relevant medical and scientific evidence.” 42 U.S.C.
§ 300aa-13(b)(1). The rule, like the statute, directs the special master to consider all
relevant and reliable evidence, unencumbered by traditional rules of admissibility, while
2009-5128 10
being guided by principles of fairness. We conclude that the special master complied
with that directive when considering Dr. Bustin’s evidence.
The special master’s decision to admit and consider Dr. Bustin’s testimony and
reports was in full accord with the principle of fundamental fairness. Although not
obligated to do so, the petitioners chose to introduce the Unigenetics data and thus
placed its validity squarely in issue. Fairness dictated that the government be given an
opportunity to refute that critical evidence. See de Bazan v. Sec’y of Health & Human
Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“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 case-in-chief.”); see also United States v.
Nobles, 422 U.S. 225, 239-40 (1975) (party introducing evidence may not invoke
attorney work-product doctrine to avoid challenges to that evidence).
As the special master noted, Dr. Bustin’s testimony and reports are highly
relevant. They speak directly to the reliability of evidence central to the petitioners’
theory of causation: the detection of persistent measles virus in autistic children who
received the MMR vaccine. As the Court of Federal Claims observed, once the
petitioners introduced that evidence, “the special master was duty-bound to assess the
reliability of those studies.” Hazlehurst, 88 Fed. Cl. at 483. Dr. Bustin’s evidence was
directly pertinent to that assessment. Moreover, the special master determined that Dr.
Bustin’s evidence was reliable. She found Dr. Bustin to be a credible witness and his
testimony to be consistent with that of other witnesses for both parties regarding PCR
testing and Unigenetics’ laboratory techniques.
2009-5128 11
We recognize, as did the trial court, that the unavailability of the Unigenetics
equipment and records limited the Hazlehursts’ ability to respond to Dr. Bustin’s
criticisms of the Unigenetics evidence. See Hazlehurst, 88 Fed. Cl. at 483-84.
Nevertheless, probative evidence need not be excluded simply because circumstances
make it difficult to challenge that evidence. See Payne v. Tennessee, 501 U.S. 808,
823 (1991) (probative evidence not inadmissible because it would be difficult to rebut).
Moreover, the special master appropriately sought to mitigate the difficulty presented by
Dr. Bustin’s evidence by giving the petitioners more than a year in which to obtain
additional information to counter Dr. Bustin’s analysis. See Hines, 940 F.2d at 1526
(post-hearing taking of judicial notice of medical evidence did not violate “principles of
fundamental fairness” where the petitioner was given a subsequent opportunity to rebut
the evidence). The petitioners, however, chose not to seek relevant reports from the
UK litigation or to recall Dr. Bustin for further questioning.
The Hazlehursts also contend that the special master’s admission of Dr. Bustin’s
testimony and reports violated the purpose of the Vaccine Act to resolve cases through
simplified procedures without the trappings of “full blown tort litigation.” In keeping with
that purpose, they assert that the special master should have excluded evidence such
as Dr. Bustin’s elaborate and costly review of Unigenetics.
It is correct that “[t]he Vaccine Act does not contemplate full blown tort litigation in
the Court of Federal Claims.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d
543, 549 (Fed. Cir. 1994). Rather, Congress intended for the Vaccine Act to establish a
compensation system that is “fair, simple, and easy to administer.” Id., citing H.R. Rep.
No. 99-908, at 7, as reprinted in 1986 U.S.C.C.A.N. 6344, 6348. In furtherance of that
2009-5128 12
purpose, Congress eliminated the usual requirement of proving fault and simplified the
process of establishing causation. For Table injuries, causation is presumed, and even
for off-Table injuries, proof of causation is simpler in certain respects than in tort
litigation. See, e.g., id. (“[T]o require identification and proof of specific biological
mechanisms would be inconsistent with the purpose and nature of the vaccine
compensation program.”); Moberly, 592 F.3d at 1325 (“Nor is a petitioner required to
point to epidemiological studies or ‘general acceptance in the scientific or medical
communities’ to prove causation, as the legal standard is a preponderance of the
evidence, not scientific certainty.”).
Nothing in those underlying principles suggests that the special master’s
consideration of Dr. Bustin’s evidence contravened the purposes of the Vaccine Act.
The special master did not expect or require the Hazlehursts to replicate Dr. Bustin’s
review of the Unigenetics laboratory procedures; rather, she offered the petitioners the
opportunity to seek reports and exhibits that had been prepared for the UK litigation, just
as the government had done. As the Court of Federal Claims observed, “given the fact
that [the government] neither commissioned nor paid for [Dr. Bustin’s] reports, it is
difficult to distinguish them conceptually from any information existing in the public
domain.” Hazlehurst, 88 Fed. Cl. at 483 n.17. We therefore discern no legal error in the
special master’s consideration of Dr. Bustin’s testimony and reports.
In any event, we agree with the Court of Federal Claims that the special master
would have reached the same conclusion regarding the reliability of the Unigenetics
data even in the absence of Dr. Bustin’s evidence. The special master stated that she
“d[id] not rely solely on [Dr. Bustin’s] testimony in evaluating the reliability of the test
2009-5128 13
results obtained by Unigenetics,” but also “consider[ed] the testimony of other witnesses
and the filed scientific literature addressing Unigenetics’ testing techniques.”
Hazlehurst, 2009 WL 332306, at *93. She discussed the testimony of the government’s
witnesses Dr. Brian J. Ward (an infectious disease specialist), Dr. Diane Griffin (an
immunologist), and Dr. Bertrus Rima (a virologist), and found it to be more persuasive
than that of petitioners’ expert Dr. Ronald Kennedy on the subject of vaccine-strain
measles virus persistence. Id. at *7, *128-32.
The special master also identified at least two key flaws in the Unigenetics data
and related articles (such as the 2002 Uhlmann article) that would have been evident
even without Dr. Bustin’s analysis. First, the positive findings of measles virus
persistence have not been successfully replicated by laboratories independent of Dr.
Wakefield or Unigenetics, despite several efforts to do so. Second, the articles “do not
include sufficient laboratory data to evaluate the conducted testing procedures and the
validity of the test results.” Hazlehurst, 2009 WL 332306, at *124. Given the
abundance of other evidence undermining the reliability of the Unigenetics test results,
the special master’s consideration of Dr. Bustin’s evidence, even if erroneous, would not
justify reversal of the special master’s decision. See Hines, 940 F.2d at 1526.
B
The Hazlehursts also argue that the special master disregarded critical evidence
regarding the reliability of the Walker group’s test results, in violation of the Vaccine
Act’s requirement to consider “all . . . relevant medical and scientific evidence.” 42
U.S.C. § 300aa-13(b)(1). They assert that the special master ignored evidence—
including testimony from Dr. Hepner and exhibits from the Walker group’s 2006 IMFAR
2009-5128 14
poster presentation—showing that the Walker group used genetic sequencing to verify
its test results. If the special master had given that evidence proper consideration, the
Hazlehursts argue, she would have found that the Walker study reliably detected
persistent vaccine-strain measles virus in the bowels of autistic children. The
Hazlehursts therefore assert that the special master’s decision to accord little weight to
the Walker group’s test results was arbitrary and capricious. We disagree.
As an initial matter, even if the special master had made no explicit reference to
the evidence that the Walker group used genetic sequencing, we would presume that
she considered that evidence. See Medtronic, Inc. v. Daig Corp., 789 F.2d 903, 906
(Fed. Cir. 1986) (“We presume that a fact finder reviews all the evidence presented
unless he explicitly expresses otherwise.”). In this case, however, it is not necessary to
rely on that presumption, as the special master’s opinion specifically refers to that
evidence. Discussing Dr. Krigsman’s testimony, the special master explained:
Dr. Krigsman stated that the preliminary findings of that [Walker group]
study show that based on the obtained PCR results, measles virus is
present in the biopsied gastrointestinal tissue taken from patients with
autism and bowel disease and examined by Dr. Krigsman. Dr. Krigsman
acknowledged, however, as did Dr. Hepner, that not all of the samples
had been sequenced for vaccine strain measles.
Hazlehurst, 2009 WL 332306, at *139 (citations to exhibits and testimony omitted).
Thus, the special master clearly understood the testimony that some, though not all, of
the Walker group’s samples were sequenced to confirm vaccine-strain specificity.
Moreover, the exhibits that the special master cited in her opinion included the June
2006 IMFAR abstract and IMFAR poster presentation—the very documents that the
Hazlehursts contend were “ignored.” We thus cannot conclude that the special master
failed to consider the evidence in question, in violation of 42 U.S.C. § 300aa-13(b)(1).
2009-5128 15
In any event, an examination of the cited exhibits and testimony reveals
inconsistent and preliminary data that provides only minimal support for the petitioners’
claim that the Walker group confirmed the presence of vaccine-strain measles virus, as
opposed to wild-type measles virus. While the abstract states that “PCR analysis on
. . . tissue from an initial 82 patients showed that 70 (85%) were positive” for measles
virus, the poster presentation states that “PCR analysis on . . . tissue from an initial 86
patients showed that 57 (66%) were positive” for measles virus. With respect to
sequencing, the abstract observes that “[f]ourteen [samples] have been verified by DNA
sequence,” but it does not state whether the sequencing was vaccine-strain specific.
The poster presentation, on the other hand, states: “Thirty five [samples] have currently
been verified by DNA sequence. Six of the thirty five MV [measles virus] positive
[samples] bear sequence that is specific to vaccine strain MV.” That information, which
suggests that only a small number of samples were successfully sequenced for
vaccine-strain measles virus, is confirmed by Dr. Krigsman’s testimony: “All we could
say at the time of this poster is that, as far as vaccine-strain-specific sequencing
positivity, a total of six specimens [] were positive . . . . So genetic material that was
specific for vaccine-strain measles virus was positive in six.” 2 Given that the Walker
group’s data reflects only a small amount of vaccine-strain-specific sequencing, it was
not inappropriate for the special master to include only a brief discussion of the Walker
group’s sequencing efforts in her opinion.
2
The Hazlehursts cite portions of Dr. Hepner’s testimony and expert report for
the proposition that the Walker group verified that the material it amplified by PCR was
vaccine-strain measles virus. However, the cited material concerning sequencing
discusses only “measles virus (MV)” generally and is therefore ambiguous regarding the
number of samples successfully sequenced for the vaccine strain of the virus.
2009-5128 16
The special master’s decision to accord little weight to the Walker group’s data
was largely based on the study’s other shortcomings and was thus well within her
discretion in weighing the evidence. Most significantly, the special master found that
the Walker group’s research was unpublished, preliminary, and incomplete. Hazlehurst,
2009 WL 332306, at *124-25, *139, *150. Embodied only in a poster presentation, the
Walker study was not subject to peer review and therefore has not been subjected to
scrutiny from the greater scientific community. See id. at *16, quoting Daubert v. Merrell
Dow Pharms., Inc., 509 U.S. 579, 594 (1993) (“The fact of publication (or lack thereof)
in a peer reviewed journal thus will be a relevant, though not dispositive, consideration
in assessing the scientific validity of a particular technique or methodology.”). In fact,
Dr. Krigsman and Dr. Hepner repeatedly described the Walker group’s data as “partial”
and “preliminary.” As the special master observed, Dr. Hepner testified that she
“certainly wouldn’t draw any conclusions about the biological significance” of the Walker
group’s test results at that early stage. In particular, Dr. Hepner noted the lack of a
“proper control source” of tissue samples from children without autism spectrum
disorders. She explained that the Walker group’s current data does “not give us any
information yet about this cohort of patients relative to a different cohort of patients.”
The special master also expressed misgivings about the Walker group’s use of
controls in its study. The special master noted that “while positive controls (specifically
‘an artificial laboratory construct’ of wild-type measles virus) have been run in each
experimental run in the study, no negative controls have been run to date because the
investigators are still looking for suitable negative controls.” Hazlehurst, 2009 WL
332306, at *125. In their reply brief, the Hazlehursts dispute the special master’s
2009-5128 17
statement that “no negative controls have been run.” They argue that negative
“technical” controls were run with every sample to check for contamination and to
assure the reliability of the PCR testing, even though the Walker group lacked certain
“experimental” controls, namely, control samples of tissue from children who tested
negative for autism.
The record is unclear as to precisely what negative controls were run. Although
Dr. Hepner testified that “no-template negative controls” were run “as a control for
contamination,” she also stated that the Walker group was still “in the process of
procuring samples that would be appropriate negative controls.” She further noted that
“the negative control at this point generally has been a no-template control because we
don’t have access to the right material.” The confusion is compounded by Dr. Bustin’s
testimony that he could not rule out the possibility of contamination—suggested by
several indicators of unidentified genetic material in the Walker group’s poster
presentation—because “there’s no negative control there.”
What is clear from the record is that, at the time of the omnibus autism hearings,
certain key controls used by the Walker group were incomplete and in flux. Most critical
is the undisputed lack of a sufficient control group of non-autistic children with which to
compare the positive findings in autistic children. If the Walker group were to find
persistent measles virus at comparable rates in both autistic and non-autistic children,
for example, such a finding would significantly undermine the petitioners’ theory that
persistent measles virus contributes to the causation of autism spectrum disorders.
Moreover, Dr. Hepner’s testimony suggests that the Walker group was also seeking a
different type of positive control to rule out the possibility of cross-contamination. That
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evidence further underscores the preliminary and unconfirmed nature of the Walker
group’s results.
Like the Court of Federal Claims, we do not believe that the Walker group’s small
amount of vaccine-strain-specific genetic sequencing “carries enough weight to
overcome the special master’s conclusion that the Walker group’s results were
preliminary, unpublished, and not entitled to substantial weight.” Hazlehurst, 88 Fed. Cl.
at 488. We therefore find no error in the special master’s determination that she could
not “place much weight on the preliminary findings of Walker study . . . specifically the
alleged findings of vaccine-strain measles virus in some of the bowel biopsies that were
tested.” Hazlehurst, 2009 WL 332306, at *125.
III
Because we find no error in the special master’s consideration of the evidence,
we also find no error in her decision to discount Dr. Corbier’s opinion that the MMR
vaccine caused Yates’s autism. By Dr. Corbier’s own admission, his opinion depended
heavily on the reliability of the scientific studies purporting to show measles virus
persistence in autistic children.
Compensation under the Vaccine Act is limited to those individuals whose
injuries or deaths can be linked causally, either by a Table Injury presumption or by a
preponderance of “causation-in-fact” evidence, to a listed vaccine. The special master
concluded that the Hazlehursts’ evidence failed to demonstrate the necessary causal
link, and the petitioners have not identified any reversible error in the special master’s
decision reaching that conclusion.
AFFIRMED.
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Hazlehurst v. Secretary of Health and Human Servs.
Court: Court of Appeals for the Federal Circuit
Date filed: 2010-05-13
Citations: 604 F.3d 1343
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