Cedillo v. Secretary of Health & Human Services

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.