Cedillo v. Secretary of Health & Human Services , 617 F.3d 1328 ( 2010 )

United States Court of Appeals
for the Federal Circuit
__________________________
THERESA CEDILLO AND MICHAEL CEDILLO,
(AS PARENTS AND NATURAL GUARDIANS OF),
MICHELLE CEDILLO,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________
2010-5004
__________________________
Appeal from the United States Court of Federal
Claims in 98-VV-916, Judge Thomas C. Wheeler.
___________________________
Decided: August 27, 2010
___________________________
RONALD C. HOMER, Conway, Homer & Chin-Caplan,
P.C. of Boston, Massachusetts, 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
CEDILLO v. HHS 2
General, TIMOTHY P. GARREN, Director, and GABRIELLE M.
FIELDING, Assistant Director.
MARY HOLLAND, Attorney-at-Law, of New York, New
York, for amicus curiae Elizabeth Birt Center for Autism
Law and Advocacy, et al.
__________________________
Before NEWMAN, LINN, and DYK, Circuit Judges.
DYK, Circuit Judge.
This case is one of approximately five thousand cases
that have been filed under the National Childhood Vac-
cine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (“Vac-
cine Act”) in the Court of Federal Claims claiming a link
between childhood vaccines and autism. The Special
Masters created the Omnibus Autism Proceeding (“OAP”)
to determine the relationship, if any, between vaccines
and autistic spectrum disorders.
Petitioners Theresa and Michael Cedillo seek com-
pensation on behalf of their daughter, Michelle Cedillo
(“Michelle”). Their case is a part of the OAP proceeding.
The Cedillos alleged that the measles-mumps-rubella
(“MMR”) vaccine together with thimerosal-containing
vaccines (“TCVs”) caused Michelle to suffer from various
medical conditions, including autism. A Special Master
denied the Cedillos’ petition, and the Court of Federal
Claims affirmed. Cedillo v. Sec’y of Health & Human
Servs., 89 Fed. Cl. 158 (2009) (“Final Decision”). We
affirm.
3 CEDILLO v. HHS
BACKGROUND
I
Michelle Cedillo was born on August 30, 1994. The
pregnancy and birth were uncomplicated. Michelle’s
pediatric visits during her first sixteen months were
unremarkable. During her first fifteen months of life, she
received routine childhood vaccinations, some of which
contained a mercury-based preservative called
thimerosal. On December 20, 1995, at fifteen months of
age, she received an MMR vaccination. She next saw her
pediatrician on January 6, 1996. The record of the visit
shows that one week after her MMR vaccination, Michelle
had a fever and rash. Although the initial fever im-
proved, she experienced another fever on January 5, 1996,
accompanied by coughing, gagging, and vomiting. By the
morning of January 6, 1996, Michelle's temperature was
105.7 degrees. Her temperature at the pediatrician’s
office was 100.3 degrees, and she had a “purulent postna-
sal drip.” Cedillo v. Sec’y of Health & Human Servs., No.
98-916V, slip op. at 4 (Fed. Cl. Feb. 12, 2009) (“Initial
Decision”). The pediatrician diagnosed “sinusitis vs. flu,”
and prescribed antibiotics. Id. Michelle next saw her
pediatrician on March 15, 1996, for an eighteen-month
well-child visit. No significant health concerns were
recorded, and Michelle was noted to “stool[] well.” Id.Her doctor also noted that Michelle was “talking less
since ill in Jan.” Id. A pediatric visit on April 24, 1997,
noted “developmental delay suspected,” and subsequent
medical records confirmed that Michelle's development
was indeed very abnormal. Id. In July 1997, Michelle
was diagnosed with “severe Autism” as well as “profound
Mental Retardation.” Id.CEDILLO v. HHS 4
In addition to Michelle’s autism and severe mental re-
tardation, Michelle has suffered from other medical
problems. She has experienced chronic constipation and
diarrhea. She has also suffered from possible gastroe-
sophageal reflux disease, erosive esophagitis, and fecal
impaction. At times, Michelle has also displayed symp-
toms of arthritis and pancreatitis and has experienced
seizures.
II
Petitioners filed for compensation under the Vaccine
Act on December 9, 1998. To obtain compensation for a
vaccine-related injury or death, a petitioner must file a
petition in the United States Court of Federal Claims and
must show, by a preponderance of the evidence, that he or
she received a vaccine listed on the Vaccine Injury Table
and suffered a corresponding listed injury, in which case
causation is presumed (“Table injury”), or that a listed
vaccine in fact caused or significantly aggravated any
injury (“non-Table injury”). See 42 U.S.C. § 300aa-11(a), -
11(c), -12(a), -12(b), -13(a). Petitioners’ theory of the case
here is “causation-in-fact” (a non-Table injury claim),
meaning that petitioners were required to prove causa-
tion. Once a petitioner establishes a prima facie case, the
government then bears the burden of establishing alter-
native causation by a preponderance of the evidence.
Walther v. Sec’y of Heath & Human Servs., 485 F.3d 1146,
1151 (Fed. Cir. 2007).
The question at the heart of this proceeding is
whether Michelle Cedillo’s admitted autism has been
shown to have been caused by certain childhood vaccines.
Petitioners claim that the ethyl mercury in thimerosal in
various childhood vaccines damaged Michelle’s immune
system, and that due to her immune deficiency, she was
5 CEDILLO v. HHS
unable to clear from her body the measles virus contained
in the MMR vaccine. As a result, the vaccine-strain
measles virus persisted and replicated in Michelle’s body,
causing her to suffer inflammatory bowel disease. Fi-
nally, the Cedillos “contend that the measles virus ulti-
mately entered her brain, causing inflammation and
autism.” Final Decision, 89 Fed. Cl. at 163.
At the Cedillos’ request, Michelle’s case was consoli-
dated into the OAP. In December of 2005, counsel repre-
senting the petitioners in the OAP, known as the
Petitioners’ Steering Committee (“PSC”), proposed a “test
case” approach to present general causation evidence and
then designated Michelle Cedillo’s case as a lead claim to
be tried in June 2007. Hazlehurst v. Secretary of Health
& Human Services., No. 03-654V, and Snyder v. Secretary
of Health & Human Services, No. 01-162V, were also
designated as test cases. Special Master Hastings pre-
sided over the Cedillo case and two other Special Masters
were assigned to the Hazlehurst and Snyder cases.
Though the general causation evidence from the three
cases was considered by the Special Masters in each of
the cases, each individual case was considered individu-
ally on its own merits by a single Special Master. 1
A three-week evidentiary hearing in this case was
held in June of 2007, in which both general causation
1 The Special Masters in Hazlehurst and Snyder
denied the respective petitions and the Court of Federal
Claims affirmed in both cases. Snyder v. Secretary of
Health and Human Services, No. 01-162V, 2009 WL
332044 (Fed. Cl. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706(2009), was not appealed to this court. While this appeal
was pending, we issued an opinion in Hazlehurst v. Secre-
tary of Health and Human Services, 604 F.3d 1343 (Fed.
Cir. May 13, 2010), in which we affirmed the denial of the
petition for compensation.
CEDILLO v. HHS 6
evidence and evidence specific to the Cedillo case was
presented. Petitioners presented testimony on general
causation from six expert witnesses. Central to petition-
ers’ theory of causation was testing done by Unigenetics
Ltd. Laboratory in Dublin, Ireland (“Unigenetics”) that
reported successful use of the polymerase chain reaction
technique (“PCR”) to identify and amplify measles virus
genetic material from the blood and intestinal tissue of
autistic children who had received the MMR vaccine,
including Michelle Cedillo. The Unigenetics research
formed the basis for a 2002 article (“the Uhlmann arti-
cle”). The Unigenetics laboratory, which is no longer in
business, was a for-profit, non-accredited institution that
was established to support United Kingdom (“UK”) civil
litigation against vaccine manufacturers in which it was
alleged that the MMR vaccine caused autism. The Uni-
genetics testing on Michelle Cedillo was performed in
2002. Due to Michelle’s gastrointestinal problems, she
had undergone multiple endoscopies. Following one such
procedure, in 2002, a tissue sample was taken from her
intestine and a measles virus detection test was per-
formed on the biopsied tissue by Unigenetics. The March
15, 2002, report of that test stated that “measles virus
was detected” in the tissue. Initial Decision, slip op. at 5.
Petitioners’ expert witnesses, Drs. Hepner and Ken-
nedy, testified that Unigenetics had reliably detected
persistent vaccine-strain measles in the bodies of children
with autism and gastrointestinal dysfunction, including
Michelle Cedillo. Drs. Kennedy and Hepner also offered
opinions supporting petitioners’ vaccine-strain mea-
sles/causation theory. Petitioners’ expert Dr. Kinsbourne
testified that vaccine-strain measles virus persisted in
Michelle’s body, damaged her brain, and thereby caused
her autism. Petitioners also relied on testimony from Dr.
Corbier from the Hazlehurst case to support their causa-
7 CEDILLO v. HHS
tion claim. Dr. Corbier testified in Hazlehurst that the
MMR vaccine can play a role in causing autism, either by
itself or in conjunction with thimerosal-containing vac-
cines, in persons with a genetic susceptibility to autism.
Petitioners’ expert Dr. Byers testified that Michelle has a
weakened immune system due to thimerosal from vac-
cines, and petitioners’ expert Dr. Aposhian testified that
“thimerosal-containing vaccines can harm infant immune
systems.” Initial Decision, slip op. at 14. Petitioners’
expert Dr. Krigsman testified as to an autism-
gastrointestinal dysfunction link and opined that the
MMR vaccine can cause chronic gastrointestinal dysfunc-
tion. He testified in particular that Michelle’s gastroin-
testinal symptoms and ultimately, her autism, were
caused by persistent measles virus from the MMR vac-
cine. Petitioners’ theory of causation depended on the
Unigenetics finding that the measles virus was present in
Michelle Cedillo’s body.
In response to petitioners’ evidence concerning the
Unigenetics testing, the government offered evidence that
the Unigenetics testing was unreliable and that therefore,
Unigenetics can not be said to have found evidence of
persisting measles virus in the intestinal tissue of any of
the children studied, including Michelle Cedillo. In
particular, in order to establish the unreliability of the
Unigenetics testing, the government offered expert testi-
mony and reports from, among others, Dr. Stephen
Bustin, a molecular biologist who was an expert in the
UK litigation. In connection with those proceedings, Dr.
Bustin was hired by vaccine manufacturers to evaluate
the testing methods used by Unigenetics and to assess the
validity of the Unigenetics work. After analyzing Unige-
netics equipment and notebooks, he concluded that the
procedures used by Unigenetics rendered the testing
unreliable. On June 7, 2007, four days before the sched-
CEDILLO v. HHS 8
uled start of the evidentiary hearing, the government filed
copies of expert reports Dr. Bustin had prepared and filed
in 2003 and 2004 in the course of the UK litigation.
These reports were under seal in the UK. However, the
government succeeded in securing their release from the
UK court. No request was made for the underlying note-
books or other data. Over objection, the Special Master
provisionally admitted the reports and permitted Dr.
Bustin to testify, but deferred a decision as to whether or
not he would rely upon the Bustin testimony in deciding
the case.
The government responded with testimony from nine
expert witnesses as well as with other written reports and
fact testimony. The government’s experts testified that
the evidence did not support a finding that TCVs can
harm infant immune systems; that the MMR vaccine
cannot cause autism in general; and that the evidence did
not support a finding that the MMR vaccine can cause
chronic gastrointestinal dysfunction.
Following the hearing in this case, the hearing in
Hazlehurst was held in October of 2007 and the hearing
in Snyder was held in November of 2007. At petitioners’
request, the general causation evidence from Hazlehurst
and Snyder was filed in the Cedillo record. The Special
Master closed the evidentiary record in this case on July
30, 2008. The full record encompasses tens of thousands
of pages of medical literature, more than four thousand
pages of hearing testimony, and fifty expert reports.
In a lengthy initial decision dated February 12, 2009,
after reviewing the voluminous record, including materi-
als from Cedillo, Hazlehurst, Snyder, and the OAP master
file, the Special Master denied Michelle’s petition for
compensation. He concluded that petitioners did not
9 CEDILLO v. HHS
demonstrate either that TCVs can harm infant immune
systems, or that they harmed Michelle’s immune system.
He also concluded that the evidence did not demonstrate
that the MMR vaccine alone or in combination with TCVs
can cause autism in general, or that the MMR vaccine
alone or in combination with TCVs caused Michelle’s
autism. The Special Master further concluded that the
evidence did not demonstrate that the MMR vaccine can
cause chronic gastrointestinal dysfunction in general, or
that the MMR vaccine did cause Michelle’s gastrointesti-
nal problems.
In particular, the Special Master evaluated the evi-
dence pertaining to the Unigenetics testing and concluded
that the Unigenetics testing for the detection of measles
virus suffered from significant flaws and was not reliable.
The Special Master relied on the Bustin testimony in his
decision, but also noted that he would have reached the
same conclusions as to the unreliability of the Unigenetics
work even in the absence of Dr. Bustin’s testimony. In
doing so, he noted that the main points in his rejection of
the Unigenetics testing were “(1) the fact that the labora-
tory failed to publish any sequencing data to confirm the
validity of its testing, (2) the failure of other laboratories
to replicate the Unigenetics testing, and (3) the demon-
stration by the D’Souza group that the Uhlmann primers
were ‘nonspecific,’” meaning that they were not specific to
measles virus genetic material. 2 Initial Decision, slip op.
2 A 2006 article by D’Souza and colleagues detailing
their attempts to replicate the Unigenetics work con-
cluded that the data published in the Uhlmann article “is
unlikely to be true.” Initial Decision, slip op. at 26. Their
primary explanation for why the Uhlmann researchers
erroneously concluded that they had found measles virus
in the tissue samples was that the primers used in the
Uhlmann study were not as “specific” as they needed to be
CEDILLO v. HHS 10
at 51. He stated that the testimony by Dr. Bustin, along
with testimony from other experts from the UK litigation,
merely provided “a secondary, additional reason to doubt
the reliability of the Unigenetics testing.” Id.On March 13, 2009, petitioners filed a motion for re-
consideration of the Special Master’s decision and at-
tached materials not previously filed. The Special Master
denied the motion as untimely and also on the ground
that the petitioners had failed to demonstrate that recon-
sideration should be granted. Petitioners then moved for
review of the Special Master’s decision by the Court of
Federal Claims. On August 6, 2009, the court affirmed
the Special Master’s initial decision, as well as his deter-
mination not to consider certain post-hearing evidence.
Petitioners timely appealed to this court, and we have
jurisdiction under 42 U.S.C. § 300aa-12(f).
DISCUSSION
We review de novo a ruling by the Court of Federal
Claims on a Special Master’s decision to grant or deny
entitlement to compensation under the Vaccine Act.
Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357,
1360 (Fed. Cir. 2000). We review the Special Master’s
legal conclusions without deference and discretionary
rulings for abuse of discretion. Id.; Saunders v. Sec’y of
Dept. of Health and Human Servs., 25 F.3d 1031, 1033
(Fed. Cir. 1994). We review the Special Master’s factual
to positively identify measles virus and only measles
virus. Id. The D’Souza researchers concluded that the
Uhlmann primers (pieces of DNA that bind to and permit
the identification and amplification of specific target DNA
material) were non-specific enough that they caused the
mistaken identification of human genetic material as
measles virus material.
11 CEDILLO v. HHS
findings using an “arbitrary or capricious” standard.
Lampe, 219 F.3d at 1360. We “do not sit to reweigh the
evidence. [If] the Special Master’s conclusion [is] based
on evidence in the record that [is] not wholly implausible,
we are compelled to uphold that finding as not being
arbitrary or capricious.” Id. at 1363. Our role is not to
“second guess the Special Master[’]s fact-intensive conclu-
sions” particularly in cases “in which the medical evidence
of causation is in dispute.” Hodges v. Sec’y of Health &
Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993).
Here, petitioners were required to demonstrate by a
preponderance of the evidence that the MMR vaccine or
thimerosal-containing vaccines contributed to the causa-
tion of Michelle’s autism or her gastrointestinal symp-
toms. See Moberly v. Sec’y of Health & Human Servs.,
592 F.3d 1315, 1321 (Fed. Cir. 2010). To prove causation,
a petitioner in a Vaccine Act case must show that the
vaccine was “not only a but-for cause of the injury but also
a substantial factor in bringing about the injury.” Shyface
v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352
(Fed. Cir. 1999). In doing so, petitioners’ burden
is to show by preponderant evidence that the
vaccination brought about her injury by providing:
(1) a medical theory causally connecting the
vaccination and the injury; (2) a logical sequence
of cause and effect showing that the vaccination
was the reason for the injury; and (3) a showing of
a proximate temporal relationship between
vaccination and injury.
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2005). If petitioners succeed in establish-
ing a prima facie case of causation, the burden then shifts
to the government to prove alternative causation by a
CEDILLO v. HHS 12
preponderance of the evidence. Walther, 485 F.3d at
1151.
I
Petitioners assert that the Special Master used an in-
correct legal standard to determine causation, in particu-
lar they assert that the Special Master erred in using the
Daubert standard to judge the reliability of the expert
testimony. See Daubert v. Merrell Dow Pharms., Inc., 509
U.S. 579, 593-94 (1993).
We see no legal error in the standards applied by the
Special Master either in judging causation or in utilizing
Daubert. The Special Master applied the correct Althen
standards for causation. We have previously held that
Special Masters may look to the Daubert standards in
evaluating expert testimony. 3 Vaccine Rule 8(b)(1) pro-
3 See Moberly v. Sec’y of Health & Human Servs.,
592 F.3d 1315, 1324 (Fed. Cir. 2010) (“Although a Vaccine
Act claimant is not required to present proof of causation
to the level of scientific certainty, the special master is
entitled to require some indicia of reliability to support
the assertion of the expert witness . . . .”) (citing Daubert);
Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367,
1379 (Fed. Cir. 2009) (citing Daubert to support the
conclusion that the special master may assess the reliabil-
ity of expert testimony by considering whether the theory
enjoys general acceptance in the scientific community);
Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302,
1316 (Fed. Cir. 1999) (approving the Special Master’s use
of the Daubert factors “as a tool or framework for conduct-
ing the inquiry into the reliability of the evidence”);
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543,
548 (Fed. Cir. 1994) (citing Daubert to support the conclu-
sion that a vaccine petitioner’s proof regarding the “logical
sequence of cause and effect” “must be supported by a
sound and reliable medical or scientific explanation”);
Perreira v. Sec’y of Health & Human Servs., 33 F.3d 1375,
13 CEDILLO v. HHS
vides that the special master will “consider all relevant
and reliable evidence.” (emphasis added). By inclusion of
the terms “relevant and reliable,” Vaccine Rule 8(b)(1)
necessarily contemplates an inquiry into the soundness of
scientific evidence to be considered by special masters. In
Daubert, the Supreme Court set forth four factors for
determining the admissibility of scientific evidence at
trial. These factors are (1) general acceptance in the
scientific community, (2) whether the theory has been
subjected to peer review and publication, (3) whether the
theory can and has been tested, and (4) whether the
known potential rate of error is acceptable. Daubert, 509
U.S. at 593-94.
It is thus quite clear that the Daubert factors may be
used in vaccine cases to assess expert witnesses’ method-
ology, but petitioners contend that the Special Master
erroneously used these factors in assessing the reliability
of the experts’ ultimate conclusions. In our decision in
Althen v. Secretary of Health & Human Services, we held
that petitioners in vaccine cases were not required to
establish “an injury recognized by the medical plausibility
evidence and literature.” 418 F.3d 1274, 1281 (Fed. Cir.
2005). Contrary to petitioners, the Special Master here
did not interpret Daubert to undermine Althen and to
require “proof of confirmation of medical plausibility from
the medical community and literature.” Petitioners’
Reply Br. 11 n.16. While Daubert does not require that
the experts’ ultimate conclusions be generally accepted in
the scientific community, and the focus of a Daubert
inquiry must generally be “‘on principles and methodol-
ogy, not on the conclusions they generate,’” “conclusions
1377 n.6 (Fed. Cir. 1994) (citing Daubert for the proposi-
tion that “[a]n expert opinion is no better than the sound-
ness of the reasons supporting it”).
CEDILLO v. HHS 14
and methodology are not entirely distinct from one an-
other . . . . A court may conclude that there is simply too
great an analytical gap between the data and the opinion
proferred.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146
(1997) (quoting Daubert, 509 U.S. at 595); see also Smith
v. Cangieter, 462 F.3d 920, 924 (8th Cir. 2006) (finding no
error in the use of Daubert to asses whether a particular
conclusion may be reliably drawn from the evidence). We
do not think that the Special Master here went beyond
what is permissible under Daubert. We see no error in
the Special Master’s decision applying Daubert in evaluat-
ing the reliability of the parties’ scientific evidence.
II
Apart from the argument concerning Daubert, peti-
tioners’ primary contention on appeal is that the Special
Master erred in permitting the government to introduce
the expert reports and testimony of Dr. Bustin because
the government did not make available the underlying
Unigenetics documents upon which Dr. Bustin relied.
Dr. Bustin first testified as an expert in the UK litiga-
tion concerning the existence of a potential link between
vaccines and autism. He was employed by vaccine manu-
facturers and asked to assess the validity of the Unigenet-
ics laboratory findings as reported by the Uhlmann
article. The documents obtained by Dr. Bustin from the
Unigenetics laboratory provided crucial support for both
of his expert reports filed in the UK. Once the govern-
ment determined that petitioners’ causation theory would
depend, in part, on the validity of the Unigenetics testing,
the government petitioned the UK court to unseal the
litigation file and release the Bustin reports. The gov-
ernment received the reports on June 7, 2007, and filed
them within about an hour of receiving them. The gov-
15 CEDILLO v. HHS
ernment did not request any underlying laboratory note-
books or other data reviewed or relied on by Bustin in the
preparation of the reports. Nor did the government
supply any information as to the location of the underly-
ing data. The government explained at oral argument
that UK counsel informed them that an application to the
UK court requesting “everything” from the UK litigation
would be denied as overbroad, and as a result, they
needed to narrow their request to the most essential
items. The government therefore subsequently “honed
down” their request to cover solely the three reports, two
of which were filed by Dr. Bustin, that they eventually
obtained. Oral Arg. 26:33-27:20.
It is unclear from the record to what extent the under-
lying data were submitted to the UK court along with
Bustin’s reports or whether the underlying data, or por-
tions thereof, still remain under seal with the UK court.
However, both parties seem to assume that at least some
of the Unigenetics materials relied on by Bustin in pre-
paring his reports were submitted to the UK court, where
they remain under seal.
In connection with the UK vaccine-autism litigation,
Dr. Bustin spent more than 1500 hours analyzing the
validity of the Unigenetics work as reported by the 2002
Uhlmann article. He was granted physical access to the
Unigenetics laboratory, was able to utilize and inspect the
lab’s equipment, and had access to all of the laboratory
notebooks and data compiled by the researchers in the
Uhlmann study. He also prepared an expert report in
Cedillo and testified during the evidentiary hearing,
wherein he again relied extensively on the Unigenetics
documents and data.
CEDILLO v. HHS 16
In both his UK expert reports and in his testimony in
this case, Dr. Bustin concluded that the Unigenetics
testing with respect to the detection of measles virus was
“severely flawed, and should not be considered reliable.”
Initial Decision, slip op. at 29. He explained what he saw
as the many problems with the laboratory and its work.
Dr. Bustin explained that in one-third of Unigenetics
procedures, the laboratory obtained positive results for
negative controls—samples which definitely do not in-
clude the targeted genetic material. He testified that
such a result means that contamination was rampant in
the Unigenetics laboratory. He also explained a particu-
lar problem with the layout of the laboratory which may
have resulted in the contamination be believes infected
the laboratory. He testified to problems with the labora-
tory notebooks, which, in his view, had been improperly
altered after the fact, in perhaps, a fraudulent manner.
He observed that the laboratory was not accredited,
declined to participate in a quality control program, and
that no independent assessment of the laboratory’s work
was ever performed. He detailed problems with the
physical equipment used at the lab, inconsistencies in the
laboratory procedures, and the poor quality of the ribonu-
cleic acid (“RNA”) used for testing, all problems that could
contribute to inaccurate results. He explained that test-
ing of certain non-equivalent samples generated equiva-
lent outcomes, a result that could only occur if the test
was detecting a contaminant, rather than the measles
virus. He also noted that on two occasions, not involving
Michelle Cedillo, technicians failed to perform a necessary
step in the protocol, yet still reported positive results—an
impossible result which can only be explained by con-
tamination. He also testified that sometimes duplicate
samples which should both either register as positive, or
negative, sometimes tested positive for one sample and
negative for the other. Unigenetics would then report
17 CEDILLO v. HHS
such samples as “positive,” an unacceptable laboratory
practice, rather than rerunning the tests. He concluded
that overall, the Unigenetics testing was detecting a
contaminant, and not measles virus, and was wholly
unreliable.
Petitioners objected to the introduction of the Bustin
reports and testimony on the grounds that those two
reports were filed shortly before the hearing in this case,
and because Dr. Bustin had access to the Unigenetics
laboratory and to their records and data which were not
made available to petitioners and their experts. The
Special Master refused to exclude the Bustin testimony,
but as described below, afforded petitioners additional
time to attempt to secure the underlying material, and
offered to assist in that effort. 4
In civil litigation conducted pursuant to the Federal
Rules of Civil Procedure, under Rule 26, a party must
disclose in discovery information “considered by” testify-
ing experts. Fed. R. Civ. P. 26. In particular, an expert
report must contain “a complete statement of all opinions
the witness will express and the basis and reasons for
them” and “the data or other information considered by
the witness in forming them.” Id. 26(a)(2)(B). See Clear-
4 The same problem existed with respect to the
government’s expert, Dr. Bertus Rima, who testified in
the Snyder case, and the government’s expert, Dr. Tho-
mas MacDonald, who testified in Hazlehurst. Both of
these experts also had access to Unigenetics data that
was not supplied to petitioners. Initial Decision, slip op.
at 30, 31. No objection was made to their testimony on
the ground the that the underlying data were not sup-
plied, but for the same reasons that there was no error
with respect to the Bustin reports and testimony, there
was no error with respect to the testimony of Drs. Rima
and MacDonald.
CEDILLO v. HHS 18
value Inc., v. Pearl River Polymers, Inc., 560 F.3d 1291,
1302 (Fed. Cir. 2009); Neiberger v. Fed Ex Ground Pack-
age Sys., Inc., 566 F.3d 1184, 1191 (10th Cir. 2009); Smith
v. Botsford Gen. Hosp., 419 F.3d 513, 516-17 (6th Cir
2005). This right to underlying documentation is viewed
as important for effective cross-examination, and as being
fundamental to the fairness of litigation. See Fed. R. Civ.
P. 26 advisory committee’s note ¶ 2 (1993 amend.); Fidel-
ity Nat’l Title Ins. Co. of N.Y. v. Intercounty Nat’l Title
Ins. Co., 412 F.3d 745, 751 (7th Cir. 2005). As we noted in
In re Pioneer Hi-Bred International, Inc., 238 F.3d 1370,
1375 (Fed Cir. 2001), “[t]he revised rule proceeds on the
assumption that fundamental fairness requires disclosure
of all information supplied to a testifying expert in con-
nection with his testimony.” (emphasis added). Virtually
the same requirement appears in the rules of the Court of
Federal Claims (“RCFC”). See RCFC 26(a)(2)(B); see also
Sparton Corp. v. United States, 77 Fed. Cl. 1, 3-4 (2007).
Under the Federal Rules of Civil Procedure and the Rules
of the Court of Federal Claims, if a party fails to provide
information required by Rule 26(a), the party is “not
allowed to use that information or witness to supply
evidence on a motion, at a hearing, or at a trial, unless
the failure was substantially justified or is harmless.”
Fed. R. Civ. P. 37(c)(1); RCFC 37(c)(1).
However, these discovery rules do not apply to pro-
ceedings under the Vaccine Act. Rather, such proceedings
are governed by Vaccine Rule 8(b)(1) with respect to the
admission of evidence, which 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).
Vaccine Rule 7(a) further provides that in vaccine cases,
“[t]here is no discovery as a matter of right. The informal
19 CEDILLO v. HHS
and cooperative exchange of information is the ordinary
and preferred practice.” Id. 7(a). Formal discovery in
vaccine cases is, however, available by motion. Under the
Vaccine Rules, “[i]f a party believes that informal discov-
ery is not sufficient, the party may move the Special
Master, either orally during a status conference or by
filing a motion, to employ any of the discovery procedures
set forth in RCFC 26-37.” Id. 7(b)(1).
We agree with petitioners that the government’s fail-
ure to produce or even to request the documentation
underlying Dr. Bustin’s reports is troubling, but we think
that in the circumstances of this case, that failure does
not justify reversal. In our recent decision in Hazlehurst,
we specifically addressed this question and held that the
failure to exclude the testimony and reports of Dr. Bustin
did not constitute reversible error. See Hazlehurst, 604
F.3d at 1348-52. In particular, we concluded that the
Special Master’s decision to admit and consider Dr.
Bustin’s testimony was “in full accord with the principle
of fundamental fairness” under Vaccine Rule 8(b)(1) and
did not “contravene[] the purpose[] of the Vaccine Act” to
avoid proceedings resembling tort litigation. Id. at 1351.
We also concluded that even if the admission of the
Bustin evidence was improper, the Special Master would
have reached the same conclusions regarding the unreli-
ability of the Unigenetics testing in the absence of the
Bustin evidence. Id. Curiously, neither the government
nor petitioners in this case ever mentioned the Hazlehurst
decision. And while Hazlehurst did not consider the
bearing of Rule 26 on this case, we think that the decision
in Hazlehurst was correct and that it governs here. That
is so for several reasons.
First, here, as in Hazlehurst, petitioners themselves
relied on expert testimony as to the validity of Unigenet-
CEDILLO v. HHS 20
ics laboratory work without producing the underlying
data. Petitioners’ expert, Dr. Kennedy, was also an
expert in the British litigation, and testified as to the
reliability of the Unigenetics work. He was not affiliated
with Unigenetics. He testified that the Unigenetics
laboratory had a good reputation and that it had its work
published in peer-reviewed medical journals. He also
stated his opinion that the laboratory used proper proce-
dures and took appropriate measures to avoid contamina-
tion. In reaching his conclusions, he relied in part on
documentary information received from Unigenetics,
including many of their laboratory notebooks. However,
like Dr. Bustin, he did not produce any underlying data
together with his testimony. The government was enti-
tled to respond to this testimony, as our opinion in Hazle-
hurst recognizes. See id. at 1349-50. As we noted in
Hazlehurst, “[a]lthough not obligated to do so, the peti-
tioners chose to introduce the Unigenetics data and thus
placed its validity squarely at issue. Fairness dictated
that the government be given an opportunity to refute
that critical evidence.” Id. at 1349.
Second, petitioners did not request that the Special
Master apply Rule 26 or order the government to secure
the underlying information.
Third, petitioners themselves did not seek to access
the data from the UK court, nor did they examine Dr.
Bustin as to the current location of the data he relied
upon in creating his reports. In the Special Master’s
evidentiary ruling denying petitioners’ motion to exclude
Bustin’s reports and testimony, he encouraged petitioners’
counsel to seek the underlying data from the UK court,
and pledged to join any request. Thereafter, the Special
Master then gave petitioners over a year to petition the
British court for access to the information. Petitioners
21 CEDILLO v. HHS
also requested that the OAP Special Masters provide a
letter supporting a possible request, which the Special
Masters did. Petitioners considered making such a re-
quest from the UK court, but never did so. They contend
that British counsel informed them that it was unlikely
that the UK court would permit disclosure of the expert
reports without the consent of the experts, which peti-
tioners stated that they could not obtain. But Dr. Bustin
did consent to the release of his reports. Once his consent
for the release of his reports had been obtained by the
government, there is no reason why the data underlying
his reports could not also have been requested.
Finally, the Special Master specifically found that
even if he were to disregard Dr. Bustin’s expert reports
and hearing testimony—and if he were to disregard all of
the testimony from all of the experts that participated in
the British litigation—he would have still concluded that
the Unigenetics testing was not reliable. In doing so, he
noted that the main points in his rejection of the Unige-
netics testing were “(1) the fact that the laboratory failed
to publish any sequencing data to confirm the validity of
its testing, (2) the failure of other laboratories to replicate
the Unigenetics testing, and (3) the demonstration by the
D’Souza group that the Uhlmann primers were ‘nonspe-
cific.’” Initial Decision, slip op. at 51. As we held in
Hazlehurst, the Special Master’s reasoned conclusion that
he would have reached the same result in the absence of
the Bustin testimony supports a conclusion that any error
in considering the Bustin testimony was, in fact harmless,
as it did not affect the outcome of the proceeding. See 604
F.3d at 1351.
Petitioners also argue that they were prejudiced by
the late introduction of Dr. Bustin’s reports from the UK
litigation after the deadline set by the Special Master for
CEDILLO v. HHS 22
the submission of expert reports and on the eve of trial.
As we noted, petitioners were given over a year thereafter
to rebut the material in the reports. The Special Master
also offered a second evidentiary hearing in which to
present such new evidence. Petitioners never requested
the second hearing, nor did they request additional cross-
examination of Dr. Bustin, a request that the Special
Master indicated he would have granted. The Special
Master did not err in allowing the late filing of the Bustin
reports.
In light of our decision sustaining the Special Mas-
ter’s conclusion as to the unreliability of the Unigenetics
testing, we also sustain the Special Master’s finding that
petitioners have failed to establish that vaccine-strain
measles virus was present in Michelle Cedillo’s body.
Thus, petitioners’ theory based on the assumed presence
of measles virus in Michelle Cedillo’s body necessarily
fails. As the Special Master found, petitioners established
no other credible theory of causation. Under these cir-
cumstances, we need not address other alternative
grounds for the Special Master’s decision.
III
Petitioners also raise other allegations of legal error
relating to the procedures utilized in the OAP. In particu-
lar, they contend that three Special Masters should not
have been used to decide the three test cases, and that the
Special Master assigned to this case should not have
considered the evidence from all three test cases. This
argument ignores the procedural history of this case.
Petitioners chose to enter the OAP in 2002 and agreed to
be the first test case in the OAP, in which the majority of
the general causation evidence would be offered. Peti-
tioners also affirmatively requested that the evidence
23 CEDILLO v. HHS
from Hazlehurst and Snyder be considered in this case. A
review of the record makes clear that petitioners were
only required to persuade Special Master Hastings of the
merits of their case and that each Special Master reached
an independent conclusion. Although petitioners objected
to the appointment of two other special masters (arguing
that the same special master should have decided all
three cases), Judge Wheeler of the Court of Federal
Claims specifically asked petitioners’ counsel during oral
argument “to identify any prejudice” from having three
special masters involved in the proceeding. Final Deci-
sion, 89 Fed. Cl. at 174. Petitioners’ counsel responded, “I
don’t know that there was any, Your Honor.” Id.
Petitioners also argue that it was “unfair” for the Spe-
cial Master to rely on testimony from Dr. Bertus Rima,
offered in Snyder, to reject Michelle’s petition, when
petitioners had no opportunity to cross-examine him. Dr.
Rima, also an expert from the British litigation, testified
in Snyder as to the reliability of the Unigenetics testing,
explaining that fundamental flaws in the testing method-
ology and laboratory practices used by Unigenetics cast
doubt upon the validity of all its test results. Again, we
observe that petitioners were the ones who requested that
all evidence from Snyder be admitted into the record in
this case. They did not object to the admission of Dr.
Rima’s testimony. Moreover, at no time after the Snyder
hearing and before the evidentiary record was closed in
this case did petitioners submit supplemental evidence or
argument addressing his testimony, nor did petitioners
ever request to cross-examine Dr. Rima. Finally, we note
again the Special Master stated that he would have
reached the same conclusion in the absence of any of the
experts from the UK litigation. We can discern no re-
CEDILLO v. HHS 24
versible error in the Special Master’s treatment of Dr.
Rima’s testimony. 5
IV
Petitioners also contend that the Special Master
abused his discretion in “ignor[ing]” certain concessions
made by the government’s experts or in “refus[ing] to
consider” certain evidence. However, the Special Master
did not ignore relevant testimony and explicitly consid-
ered the evidence in question with a few limited excep-
tions. Petitioners primarily argue that the Special
Master considered, but erroneously declined to credit,
certain evidence, or to draw from it conclusions favorable
to petitioners. We have reviewed petitioners’ arguments
and we find them to be unpersuasive. In the Special
Master’s careful and thorough opinion, he considered,
weighed, and stated his reasons for rejecting or discount-
ing each item of evidence in which the petitioners relied.
With respect to many of petitioners’ claims of error, no
discussion is necessary because there is no possible basis
5 Petitioners observe that Dr. Rima made a mathe-
matical error in his testimony in Snyder. Dr. Rima testi-
fied that certain of the petitioner in Snyder’s test results
from Unigenetics were so unbelievably high as to be
biologically implausible. Both the Special Master and the
Court of Federal Claims cited this testimony. This error
occurred when Dr. Rima attempted to perform a mathe-
matical calculation in his head while testifying and is not
contained in his reports or his affidavit. Again, because
the Special Master concluded that he would have reached
the same conclusion in the absence of Dr. Rima’s testi-
mony, and because though Dr. Rima may have erred, his
testimony was unequivocal that the Unigenetics results
were unreliable whether the particular value at issue was
high or low, we find that any error in his testimony was
harmless.
25 CEDILLO v. HHS
for the claim of error. We discuss only petitioners’ pri-
mary claims.
1. Petitioners contend that the Special Master ig-
nored a number of significant concessions regarding the
reliability of the Unigenetics laboratory testing. They
argue that in view of these concessions, the Special Mas-
ter erred in finding the Unigenetics testing to be unreli-
able.
In particular, petitioners describe Dr. Bustin’s and
Dr. Rima’s testimony regarding the reliability of the
Unigenetics work as equivocal, or as only applying to
some of the Unigenetics results, but not all. However, as
both the Special Master and the court noted, Dr. Bustin
and Dr. Rima clearly testified that their criticisms were
not simply limited to certain of Unigenetics’ results and
that they found all of the Unigenetics work to be unreli-
able. Petitioners also urge that a letter written by a Dr.
Michael Oldstone, which was filed in Snyder, supports the
reliability of the Unigenetics work. To the contrary—Dr.
Oldstone’s letter is clear in stating that he could not
reliably replicate the Unigenetics results and that the 20
percent error rate he encountered completely undermined
his confidence in the testing. It was on this basis that he
declined further work with the laboratory. We find that
the Special Master considered all of the evidence in
context and did not err in concluding that the Unigenetics
testing was unreliable.
2. Petitioners contend that British researcher Dr.
Finbar Cottor was able to replicate the Unigenetics test-
ing, and that he was able to reach similar results to those
achieved by Unigenetics. Petitioners argue that the
Special Master erred in discounting his work as evidence
supporting the reliability of the Unigenetics testing. We
CEDILLO v. HHS 26
see no error in the Special Master’s treatment of the
evidence concerning Dr. Cottor’s work. The only evidence
concerning Dr. Cottor’s work consisted of conflicting
statements made by both parties’ experts, who disagreed
as to whether or not Dr. Cottor’s laboratory was able to
duplicate the Unigenetics results. No records of Dr.
Cottor’s work and no testimony or statement from him
were presented. Also, Dr. Cottor’s work was never pub-
lished. Given the limited record concerning Dr. Cottor’s
work, the Special Master reasonably concluded that “it is
simply impossible to draw any conclusions either way”
about Dr. Cottor’s work. Initial Decision, slip op. at 32
(emphasis in original).
3. Petitioners also argue that the Special Master “re-
fus[ed] to consider” that immunohistochemistry testing by
Unigenetics showed that measles virus protein was
present in the children tested. Petitioners’ Br. 48. This
testing was different than the PCR testing discussed
above. At the hearing, petitioners’ expert Dr. Kennedy
testified that he orally received information from Unige-
netics regarding the successful use of immunohistochem-
istry to identify measles virus protein. Petitioners allege
that the Special Master improperly discounted this testi-
mony and that the Special Master improperly discounted
references in the Uhlmann paper itself to the Unigenetics
immunohistochemistry work.
The Special Master observed that though the
Uhlmann paper “mentioned” immunohistochemistry, it
provided no data or details concerning the use of the
technique. See Initial Decision, slip op. at 38-40. Fur-
ther, he noted that there was nothing in the article that
stated that any immunohistochemistry work had identi-
fied measles virus protein. Id. at 39. The Special Master
noted the lack of a written record or details about any of
27 CEDILLO v. HHS
the testing and found the evidence to be unconvincing
that immunohistochemistry performed at Unigenetics
“demonstrated the presence of measles protein in the
tissue of autistic children.” Id. We see no error in the
Special Master’s rejection of Dr. Kennedy’s conclusory
testimony, which relied solely on unsubstantiated oral
communications from Unigenetics personnel. We also see
no error in the Special Master’s conclusion that the
Uhlmann article itself does not demonstrate that any
immunohistochemistry work performed by Unigenetics
demonstrated the presence of measles protein in the
tissue of autistic children.
4. Petitioners argue that the Special Master dis-
counted evidence concerning allelic discrimination, a
technique allegedly used by Unigenetics to distinguish
between wild-type and vaccine-strain measles virus. One
issue in this case is whether any measles virus genetic
material allegedly recovered by Unigenetics from autistic
children in general, or from Michelle Cedillo in particular,
was vaccine-strain in origin or whether it was of the
naturally occurring type (“wild-type”). The Uhlmann
article does not purport to show that the measles virus
allegedly found in the children’s biopsies was vaccine-
strain measles virus. Similarly, the results of Michelle’s
biopsy state only that measles virus was identified—not
vaccine-strain measles virus.
On January 31, 2008, months after the evidentiary
hearing, petitioners attempted to establish that the
recovered genetic material was indeed vaccine-strain in
origin by providing the synopsis of an article by certain
Unigenetics principal researchers that suggested that
Unigenetics successfully used allelic discrimination to
determine that measles virus genetic material extracted
from the autistic children was in fact vaccine-strain
CEDILLO v. HHS 28
measles virus. The actual article itself was not submit-
ted. The article synopsis did not include any information
specific to the results of Michelle Cedillo’s tests. The
Special Master specifically discussed the article synopsis
and clearly articulated why he ascribed little weight to it,
noting in particular that petitioners provided only a brief
synopsis of the article which included no details and
observed that none of petitioners’ experts offered any
testimony as to the research described in the synopsis or
endorsed its accuracy. He also noted that there is no
evidence that the work described in the synopsis was ever
submitted for peer review and publication. See Initial
Decision, slip op. at 41-42; see also Final Decision, 89 Fed.
Cl. at 173. Further, as the Court of Federal Claims
observed, it is irrelevant whether allelic discrimination
was used to determine whether any measles virus recov-
ered was vaccine in origin in light of the conclusion that
Unigenetics was unable to reliably identify measles virus
at all. Final Decision, 89 Fed. Cl. at 173.
We see no error in the Special Master’s decision to as-
cribe little weight to the article synopsis.
5. Petitioners also argue that the Special Master “re-
fus[ed] to consider” that the government’s expert Dr.
Griffin had herself published an article in which she
detected measles genetic material in the blood of immu-
nodeficient children, children with HIV. See Petitioners’
Br. 39-40, 44-45. In the article, she concluded that the
measles virus was active and replicating in the children
studied. The article does not conclude that there is a
connection between the administration of vaccines and
the presence of measles virus. Petitioners offer this
article as evidence that the government concedes that the
recovery of measles genetic material from immunocom-
promised individuals is evidence of persistent, replicating,
29 CEDILLO v. HHS
measles virus, and that the recovery of measles protein is
not necessary for one to reach a conclusion in any particu-
lar instance that the measles virus was persisting and
replicating. The Special Master did not discuss this
article in his decision. As the Court of Federal Claims
observed, petitioners’ counsel never asked Dr. Griffin
about this article during cross-examination, and none of
petitioners’ expert witnesses relied upon this article. See
Final Decision, 89 Fed. Cl. at 178. Given that there was
no testimony offered by any expert as to the validity or
import of such an article for this case, the Special Master
did not err in disregarding such evidence, which at best
addressed a peripheral issue.
6. Petitioners also argue that the Special Master
erred in rejecting the opinion of Dr. Krigsman, petition-
ers’ gastroenterology expert and one of Michelle’s treating
physicians. Dr. Krigsman testified that Michelle has
inflammatory bowel disease and that the MMR vaccine
caused her gastrointestinal symptoms. The Special
Master noted that he did not find Dr. Krigsman to be a
credible witness. He also concluded that Dr. Krigsman’s
opinion should be rejected because 1) he relied on the
discredited Unigenetics testing in forming his opinion, 2)
he misunderstood Michelle’s medical history and his
testimony was inconsistent with her medical records, and
3) his conclusion that Michelle suffered from chronic
gastrointestinal inflammation was substantially out-
weighed by Michelle’s medical records and the testimony
of the government’s experts.
Under the Vaccine Act, Special Masters are accorded
great deference in determining the credibility and reliabil-
ity of expert witnesses. Indeed, we have held that a
Special Master’s “credibility determinations are virtually
unreviewable.” Hanlon v. Sec’y of Health & Human
CEDILLO v. HHS 30
Servs., 191 F.3d 1344, 1349 (Fed. Cir. 1999) (quotation
omitted). We will not disturb the Special Master’s analy-
sis and credibility assessment on appeal, especially
where, as here, the Special Master clearly articulated his
reasons for discrediting the expert’s opinion. We can
discern no error in the Special Master’s evaluation of the
evidence. Further, even if one were to credit Dr. Krigs-
man’s opinion, his testimony provides no support as to the
crucial issue in this case—the reliability of the Unigenet-
ics testing.
7. Petitioners also contend that the Special Master
erred in discounting the opinions of Michelle’s treating
physicians, several of whom associated her illness with
her MMR vaccine. Petitioners argue that under our
decision in Capizzano v. Sec’y of Health & Human Affairs,
the opinions of treating physicians should be given sig-
nificant probative weight. See 440 F.3d 1317, 1326 (Fed.
Cir. 2006) (observing that “medical records and medical
opinion testimony are favored in vaccine cases, as treat-
ing physicians are likely to be in the best position to
determine whether a logical sequence of cause and effect
shows that the vaccination was the reason for the injury”)
(quotation omitted). The treating physicians did not
testify. Petitioners cited nine notations in Michelle’s
records from eight individuals, including four physicians
who treated Michelle and four non-physicians who exam-
ined Michelle, in which the treating physicians mentioned
her vaccinations, as support for the proposition that these
individuals concluded that her autism was caused by her
MMR vaccine.
The Special Master did not err in failing to afford sig-
nificant weight to the opinions of Michelle’s treating
physicians. As the Special Master observed in his deci-
sion, in seven of the nine notations, the physician was
31 CEDILLO v. HHS
simply indicating an awareness of a temporal, not causal,
relationship between the fever Michelle experienced after
her MMR vaccine and the emergence of her autistic
symptoms sometime thereafter. Initial Decision, slip op.
at 100. In one of the other notations, the physician sim-
ply noted that an exemption for Michelle from vaccination
requirements could be arranged. In the other notation,
the physician speculated that Michelle’s fevers might
have caused her neurological abnormalities. However, he
expressly stated that it would be “difficult to say” whether
this was “a post-immunization phenomenon, or a separate
occurrence.” Id. at 100. Thus, “none of the treating
physicians concluded that the MMR vaccine caused
Michelle’s autism.” Final Decision, 89 Fed. Cl. at 176.
The Special Master clearly articulated why he declined to
afford significant weight to the notations made by Mi-
chelle’s treating physicians, and we see no error in his
treatment of that evidence.
V
Petitioners contend that the Special Master abused
his discretion in denying their motion for reconsideration
in light of “significant” post-hearing evidence. Petitioners’
Br. 51. The Special Master denied the motion for recon-
sideration because it was untimely, because all but one of
the items submitted with the motion were available
before the filing of his decision, and because in light of the
new material submitted with the motion, reconsideration
was not warranted.
Petitioners filed their motion for reconsideration with
the Special Master on March 13, 2009, outside of the 21-
day period for filing such motions and three days before a
motion for review would have been due in the Court of
Federal Claims. See Vaccine Rule 10(e)(1) (providing that
CEDILLO v. HHS 32
“[e]ither party may file a motion for reconsideration of the
special master’s decision within 21 days of the issuance of
the decision if a judgment has not been entered and no
motion for review under Vaccine Rule 23 has been filed”).
It is undisputed that petitioners did not file a timely
motion for reconsideration and they have offered no
explanation for the late filing. Therefore, the Special
Master did not abuse his discretion in denying the motion
for reconsideration on the grounds that it was untimely.
Petitioners also argue that, even if the motion was
untimely, the Special Master abused his discretion in
denying the motion because significant new evidence
submitted with the motion rendered it in the interest of
justice to reconsider the decision. See id. R. 10(e)(3)
(providing that “[t]he special master has the discretion to
grant or deny the motion [for reconsideration], in the
interest of justice”). However, the Special Master re-
viewed the materials submitted with the motion and
observed that with the exception of one medical journal
article, all of the materials were available prior to the
filing of his decision. The Special Master did not abuse
his discretion in declining to grant reconsideration in view
of evidence that was previously available and which did
not in fact support petitioners’ position on the central
issues. 6
6 Petitioners suggest that they submitted an article
that constituted “compelling new evidence with respect to
the reliability of [Unigenetics]” and which “proved that
the [Unigenetics] operating techniques and results were
reliable.” Petitioners’ Reply Br. 6. The article describes a
study which assessed the possibility of a connection
between measles virus vaccines, autism, and gastrointes-
tinal problems. In the course of the study, measles virus
RNA was recovered from one child with autism and
gastrointestinal dysfunction, and from one child in the
33 CEDILLO v. HHS
The one new article was published in the March 2009
issue of the journal Pediatrics. The record reflects that
petitioners downloaded it from www.pediatrics.org on
March 4, 2009, and the Special Master’s decision was
issued on February 12, 2009. The article was not avail-
able before the original decision. Nevertheless, the Spe-
cial Master did not err in refusing to reopen the
proceeding based on the article. The Special Master
found the article to be “of very dubious relevance.” Final
Decision, 89 Fed. Cl. at 181. Petitioners argue here, as
they did before the Special Master, that the article “sheds
further light on the relationship between autism and
gastrointestinal problems.” J.A. 473. However, though
the article discusses a potential link between autism and
gastrointestinal dysfunction, we agree with the Special
Master that it does not assist in repairing what he viewed
as the “fatal deficiency in the petitioner’s causation theo-
ries: the lack of any persuasive evidence that the measles
vaccine can contribute to the causation of autism or
gastrointestinal dysfunction.” Cedillo v. Sec’y of Health &
Human Servs., No. 98-916V (Fed. Cl. Mar. 16, 2009)
control group, who only exhibited gastrointestinal dys-
function. There is no indication that the children tested
by Unigenetics were tested in this study. The fact that
measles virus could be present in some autistic children,
does not confirm the reliability of the Unigenetics testing
or suggest that measles virus was present in the children
tested by Unigenetics. The article explicitly concludes
that there is no link between measles virus vaccine,
autism and gastrointestinal dysfunction. The article is
titled “Lack of Associated between Measles Virus Vaccine
and Autism with Enteropathy: A Case-Control Study,”
and it states that “this study provides strong evidence
against association of autism with persistent [measles
virus] RNA in the GI tract or MMR exposure.” J.A. 626.
CEDILLO v. HHS 34
(order denying motion for reconsideration). Indeed, the
Special Master noted in his initial decision that
it is not necessary for me to determine, in this
case, to what extent autistic children have an in-
creased risk for gastrointestinal dysfunction, or to
determine why, in general, autism or regressive
autism might be associated with excessive GI
problems. Rather, the issues relevant here con-
cern whether the MMR vaccine plays a causal role
concerning chronic GI symptoms in autistic chil-
dren . . . .
Initial Decision, slip op. at 97-98 (footnote omitted). As
the Special Master explicitly declined in his initial deci-
sion to address the issue to which the article was directed,
he did not err in declining to grant reconsideration in
light of additional evidence possibly pertaining to a link
between autism and gastrointestinal dysfunction. In any
event, the article is irrelevant to the issue of the Unige-
netics testing. Accordingly, we find that the Special
Master did not act against the interests of justice in
denying the motion for reconsideration.
Finally, Petitioners accuse the Special Master of abdi-
cating his duty to be fair and impartial. We see no basis
for questioning the fairness or the impartiality of the
Special Master.
VI
In conclusion, we have carefully reviewed the decision
of the Special Master and we find that it is rationally
supported by the evidence, well-articulated, and reason-
able. We therefore affirm the denial of the Cedillos’
petition for compensation.
35 CEDILLO v. HHS
AFFIRMED
COSTS
No costs.