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 petitionersappellants. 

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 Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (“Vaccine 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 compensation 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 improved, 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 postnasal 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 retardation, Michelle has suffered from other medical 

problems. She has experienced chronic constipation and 

diarrhea. She has also suffered from possible gastroesophageal reflux disease, erosive esophagitis, and fecal 

impaction. At times, Michelle has also displayed symptoms 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 causation. Once a petitioner establishes a prima facie case, the 

government then bears the burden of establishing alternative 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. Finally, the Cedillos “contend that the measles virus ultimately entered her brain, causing inflammation and 

autism.” Final Decision, 89 Fed. Cl. at 163. 

At the Cedillos’ request, Michelle’s case was consolidated into the OAP. In December of 2005, counsel representing 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 presided 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 individually 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. Secretary 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 petitioners’ 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 article”). 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 Unigenetics 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 performed 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 Kennedy, 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 measles/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 vaccines, in persons with a genetic susceptibility to autism. 

Petitioners’ expert Dr. Byers testified that Michelle has a 

weakened immune system due to thimerosal from vaccines, 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 autismgastrointestinal dysfunction link and opined that the 

MMR vaccine can cause chronic gastrointestinal dysfunction. He testified in particular that Michelle’s gastrointestinal symptoms and ultimately, her autism, were 

caused by persistent measles virus from the MMR vaccine. 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 testimony 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 Unigenetics 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 notebooks 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 materials 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 gastrointestinal problems. 

In particular, the Special Master evaluated the evidence 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 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 ‘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 concluded 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 reconsideration of the Special Master’s decision and attached 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 reconsideration 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 determination 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 conclusions” 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 causation of Michelle’s autism or her gastrointestinal symptoms. 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 establishing 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 incorrect legal standard to determine causation, in particular 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 reliability 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 conducting 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 conclusion 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’ methodology, 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 methodology, not on the conclusions they generate,’” “conclusions 

 

1377 n.6 (Fed. Cir. 1994) (citing Daubert for the proposition that “[a]n expert opinion is no better than the soundness of the reasons supporting it”). 
CEDILLO v. HHS 14

and methodology are not entirely distinct from one another . . . . 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 evaluating the reliability of the parties’ scientific evidence.

II 

Apart from the argument concerning Daubert, petitioners’ 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 litigation concerning the existence of a potential link between 

vaccines and autism. He was employed by vaccine manufacturers and asked to assess the validity of the Unigenetics 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 government 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 government 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 notebooks 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 underlying 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 underlying data were submitted to the UK court along with 

Bustin’s reports or whether the underlying data, or portions 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 preparing 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 include the targeted genetic material. He testified that 

such a result means that contamination was rampant in 

the Unigenetics laboratory. He also explained a particular 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 laboratory 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 ribonucleic acid (“RNA”) used for testing, all problems that could 

contribute to inaccurate results. He explained that testing of certain non-equivalent samples generated equivalent 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 contamination. 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” testifying 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. Thomas 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 supplied, 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 Package 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.); Fidelity 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 connection 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 proceedings 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 discovery 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 failure 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 unreliability 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 procedures and took appropriate measures to avoid contamination. 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 entitled to respond to this testimony, as our opinion in Hazlehurst recognizes. See id. at 1349-50. As we noted in 

Hazlehurst, “[a]lthough not obligated to do so, the petitioners 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 request 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 petitioners 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 Unigenetics 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 ‘nonspecific.’” 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 crossexamination 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 Master’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 circumstances, 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 particular, 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. Petitioners 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 Decision, 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 Special 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 methodology 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 considered the evidence in question with a few limited exceptions. 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 discounting 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 mathematical error in his testimony in Snyder. Dr. Rima testified 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 mathematical 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 testimony, 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’ primary claims. 

1. Petitioners contend that the Special Master ignored a number of significant concessions regarding the 

reliability of the Unigenetics laboratory testing. They 

argue that in view of these concessions, the Special Master erred in finding the Unigenetics testing to be unreliable. 

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 unreliable. 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 testing, 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 published. 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 “refus[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 Unigenetics regarding the successful use of immunohistochemistry to identify measles virus protein. Petitioners allege 

that the Special Master improperly discounted this testimony 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. Further, he noted that there was nothing in the article that 

stated that any immunohistochemistry work had identified 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 discounted 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 vaccinestrain 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 submitted. 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 recovered 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 ascribe little weight to the article synopsis. 

5. Petitioners also argue that the Special Master “refus[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 immunodeficient 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 immunocompromised 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 particular 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, petitioners’ 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 outweighed 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 reliability 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 analysis 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. Krigsman’s opinion, his testimony provides no support as to the 

crucial issue in this case—the reliability of the Unigenetics 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 significant 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 treating 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 examined 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 significant weight to the opinions of Michelle’s treating 

physicians. As the Special Master observed in his decision, 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 simply 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 Michelle’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 reconsideration 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 reviewed 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 gastrointestinal 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 available before the original decision. Nevertheless, the Special 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 theories: 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 dysfunction. 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 increased 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 concern whether the MMR vaccine plays a causal role 

concerning chronic GI symptoms in autistic children . . . . 

Initial Decision, slip op. at 97-98 (footnote omitted). As 

the Special Master explicitly declined in his initial decision 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 Unigenetics 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 abdicating 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 reasonable. We therefore affirm the denial of the Cedillos’ 

petition for compensation. 
35 CEDILLO v. HHS

AFFIRMED 

COSTS

No costs.