# United States Court of Appeals **for the Federal Circuit**

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THERESA CEDILLO AND MICHAEL CEDILLO, (AS PARENTS AND NATURAL GUARDIANS OF), MICHELLE CEDILLO,

Petitioners-Appellants,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.

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2010-5004

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Appeal from the United States Court of Federal Claims in 98-VV-916, Judge Thomas C. Wheeler.

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Decided: August 27, 2010

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R ONALD C. H OMER , Conway, Homer & Chin-Caplan,P.C. of Boston, Massachusetts, argued for petitionersappellants.

L YNN E. R ICCIARDELLA , Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, of Washington, DC, argued for respondent-appellee. With
her on the brief were T ONY W EST , Assistant AttorneyCEDILLO v. HHS 2

General, T IMOTHY P. G ARREN , Director, and G ABRIELLE M.

F IELDING , Assistant Director.

M ARY H OLLAND , Attorney-at-Law, of New York, New York, for amicus curiae Elizabeth Birt Center for Autism Law and Advocacy, et al.

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Before N EWMAN , L INN , and D YK

, Circuit Judges

.
D YK

, 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.CEDILLO v. HHS 3

B ACKGROUND

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, Michellehad 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’soffice 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 experience d chronic constipation and
diarrhea. She has also suffered from possible gastroesophageal reflux disease, er osive 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 est ablishes a prima facie case, thegovernment 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 hear t 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 wasCEDILLO v. HHS 5

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 inflamma tory bowel disease. Finally, the Cedillos “contend th at 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 alsodesignated as test cases. Special Master Hastings presided over the Cedillo case and two other Special Masters were assigned to the Hazlehurst and Snydercases. Though the general causation evidence from the three cases was considered by the Special Masters in each ofthe cases, each individual case was considered individually on its own merits by a single Special Master. 1

A three-week evidentiary he aring 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 generalcausation 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 re ceived the MMR vaccine, including Michelle Cedillo. The Unigenetics research
formed the basis for a 2002 ar ticle (“the Uhlmann article”). The Unigenetics labora tory, which is no longer in business, was a for-profit, non-accredited institution that was established to support Un ited 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 herintestine 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 measle s in the bodies of children with autism and gastrointestinal dysfunction, including
Michelle Cedillo. Drs. Kenne dy and Hepner also offeredopinions 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-CEDILLO v. HHS 7

tion claim. Dr. Corbier testified in Hazlehurst that the MMR vaccine can play a role in causing autism, either byitself or in conjunction with thimerosal-containing vaccines, in persons with a genetic susceptibility to autism. Petitioners’ expert Dr. Byers testified that Michelle has aweakened 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 theMMR vaccine can cause chronic gastrointestinal dysfunction. He testified in particul ar that Michelle’s gastrointestinal symptoms and ulti mately, her autism, were caused by persistent meas les 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 theUnigenetics 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 connectio n 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 wo rk. 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 ob jection, 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 wi th 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 Snyderwas 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 en compasses 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 notCEDILLO v. HHS 9

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 caus e 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 sequ encing data to confirm the validity of its testing, (2) the failure of other laboratoriesto 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 detailingtheir 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 beCEDILLO v. HHS 10

at 51. He stated that the testimony by Dr. Bustin, along with testimony from other expe rts 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 groundthat 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 affirmedthe 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).

D ISCUSSION

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 revi ew 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 amplific ation of specific target DNA material) were non-specific en ough that they caused the mistaken identification of human genetic material as measles virus material.CEDILLO v. HHS 11

findings using an “arbitrary or capricious” standard. Lampe , 219 F.3d at 1360

. We “do not sit to reweigh the evidence. [If] the Special Mast er’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 orthimerosal-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 brin ging 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 inju ry; 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 aCEDILLO 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 Spec ial 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 th e 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 theconclusion 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,CEDILLO v. HHS 13

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 te sted, 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 asse ss expert witnesses’ methodology, but petitioners contend that the Special Master erroneously used these factor s in assessing the reliability of the experts’ ultimate conclu sions. 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 conclusi ons be generally accepted in the scientific community, and the focus of a Daubertinquiry 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 draw n 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 testim ony 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 obtain ed by Dr. Bustin from the Unigenetics laboratory provid ed 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 th e Bustin reports. The government received the reports on June 7, 2007, and filed them within about an hour of receiving them. The gov-CEDILLO v. HHS 15

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 governmentsupply 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 overbroa d, 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 so lely the three reports, two of which were filed by Dr. Bu stin, 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 submi tted 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 abl e 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 conc luded 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 th e laboratory and its work. Dr. Bustin explained that in one-third of Unigenetics procedures, the laboratory obtained positive results fornegative controls—samples which definitely do not include the targeted genetic material. He testified that such a result means that contamination was rampant inthe 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 hi s view, had been improperly altered after the fact, in perhaps, a fraudulent manner.

He observed that the labo ratory 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 thelaboratory procedures, and the poor quality of the ribonucleic acid (“RNA”) used for testing, all problems that could

contribute to inaccurate result s. 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—animpossible 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 reportCEDILLO v. HHS 17

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 measle s 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, und er Rule 26, a party mustdisclose 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 Snydercase, 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 onthe ground the that the underlying data were not supplied, but for the same reas ons 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 disclosureof 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 he aring, 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 evid ence but must consider all relevant and reliable evidence governed by principles of fundamental fairness to both part ies.” Vaccine R. 8(b)(1). Vaccine Rule 7(a) further prov ides that in vaccine cases, “[t]here is no discovery as a matter of right. The informalCEDILLO v. HHS 19

and cooperative exchange of information is the ordinary and preferred practice.” Id. 7(a). Formal discovery in vaccine cases is, however, ava ilable by motion. Under theVaccine 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 testimon y and reports of Dr. Bustin

did not constitute reversible error. See Hazlehurst , 604 F.3d at 1348-52. In particul ar, 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 wouldhave 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 test ified that the Unigenetics laboratory had a good reputati on and that it had its work published in peer-reviewed medical journals. He alsostated his opinion that the laboratory used proper procedures and took appropriate measures to avoid contamination. In reaching his conclu sions, 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 datatogether 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 themselv es did not seek to access the data from the UK court, nor did they examine Dr.
Bustin as to the current loca tion 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. PetitionersCEDILLO v. HHS 21

also requested that the OAP Special Masters provide a letter supporting a possible request, which the SpecialMasters 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 expertreports without the consent of the experts, which petitioners stated that they coul d not obtain. But Dr. Bustin
did consent to the release of hi s 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 disregar d 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, henoted that the main points in his rejection of the Unigenetics testing were “(1) the fa ct 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 theD’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 test imony 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 forCEDILLO v. HHS 22

the submission of expert report s 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 requestedthe 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 establishedno 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 utiliz ed 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 ofthe general causation evidence would be offered. Petitioners also affirmatively requested that the evidenceCEDILLO v. HHS 23

from Hazlehurst and Snyderbe 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 ot her 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 pr ejudice” from having three special masters involved in the proceeding. Final Decision , 89 Fed. Cl. at 174. Petition ers’ 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 test imony 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 th e British litigation, testified

in Snyderas 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 obje ct 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 subm it 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 litigatio n. We can discern no re-CEDILLO v. HHS 24

versible error in the Specia l 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 ex perts or in “refus[ing] to consider” certain evidence. However, the Special Masterdid 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 erroroccurred 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 th at 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.CEDILLO v. HHS 25

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. Theyargue 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 testifie d that their criticisms were not simply limited to certain of Unigenetics’ results and that they found all of the Un igenetics 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 th e 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. WeCEDILLO 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 part ies’ experts, who disagreed
as to whether or not Dr. Co ttor’s laboratory was able to duplicate the Unigenetics resu lts. 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. Kennedytestified that he orally received information from Unigenetics regarding the successful use of immunohistochemistry to identify measles virus protein. Petitioners allegethat 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 thatstated 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 ofCEDILLO v. HHS 27

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 whet her 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 virusallegedly found in the children’s biopsies was vaccinestrain measles virus. Similarl y, the results of Michelle’s biopsy state only that meas les 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 synops is of an article by certain Unigenetics principal resea rchers that suggested that Unigenetics successfully used allelic discrimination to determine that measles virus genetic material extracted
from the autistic children was in fact vaccine-strainCEDILLO v. HHS 28

measles virus. The actual article itself was not submitted. The article synopsis di d not include any information specific to the results of Michelle Cedillo’s tests. The Special Master specifically di scussed 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 al so 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 th e Court of Federal Claims observed, it is irrelevant whether allelic discriminationwas 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 shedetected measles genetic material in the blood of immunodeficient children, children with HIV. See Petitioners’ Br. 39-40, 44-45. In the arti cle, she concluded that the measles virus was active and replicating in the children
studied. The article does no t conclude that there is a
connection between the administration of vaccines and the presence of measles viru s. Petitioners offer this article as evidence that the government concedes that therecovery of measles genetic material from immunocompromised individuals is evidence of persistent, replicating,CEDILLO v. HHS 29

measles virus, and that the recovery of measles protein is not necessary for one to reach a conclusion in any particular instance that the measle s 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 ex pert as to the validity or import of such an article for this case, the Special Master did not err in disregarding su ch evidence, which at best addressed a peripheral issue.

6. Petitioners also argue that the Special Master erred in rejecting the opinio n of Dr. Krigsman, petitioners’ gastroenterology expert and one of Michelle’s treating physicians. Dr. Krigsman te stified 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 Mich elle suffered from chronic gastrointestinal inflammati on was substantially outweighed by Michelle’s medica l records and the testimony of the government’s experts.

Under the Vaccine Act, Special Masters are accordedgreat 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 & HumanCEDILLO v. HHS 30

Servs. , 191 F.3d 1344, 1349 (Fed. Cir. 1999) (quotationomitted). We will not disturb the Special Master’s analysis and credibility assessmen t 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 thecrucial 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 phys icians should be given significant probative weight. See 440 F.3d 1317, 1326 (Fed. Cir. 2006) (observing that “medical records and medicalopinion 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 physicianswho 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 Ma ster observed in his decision, in seven of the nine notations, the physician wasCEDILLO v. HHS 31

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 arrang ed. 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-h earing 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 thatCEDILLO v. HHS 32

“[e]ither party may file a moti on 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 theinterest 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 petitioner s’ 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 connectionbetween 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 theCEDILLO v. HHS 33

The one new article was pu blished 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 wasissued 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 pers uasive 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 reliabilit y 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 stud y 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 thiscase, 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 GIproblems. Rather, the issues relevant here concern whether the MMR vaccine plays a causal roleconcerning 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 anyevent, the article is irrelevant to the issue of the Unigenetics testing. Accordingly, we find that the Special Master did not act against th e interests of justice in denying the motion for reconsideration.

Finally, Petitioners accuse th e Special Master of abdicating his duty to be fair an d 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, we ll-articulated, and reasonable. We therefore affirm the denial of the Cedillos’ petition for compensation.CEDILLO v. HHS 35

AFFIRMED

C OSTS

No costs.