Snyder ex rel. Snyder v. Secretary of Health & Human Services
Full Opinion (html_with_citations)
OPINION AND ORDER
Petitioners seek compensation under the National Childhood Vaccine Injury Act of 1986 (âVaccine Actâ), 42 U.S.C. §§ 300aa-l to -34 (2006), alleging that their son, Colten, developed a pervasive developmental disorder caused by a combination of thimerosal-containing vaccines and the Measles-Mumps-Rubella (âMMRâ) vaccine. This ease is one of over 4,700 currently pending before the United States Court of Federal Claimsâ Office of Special Masters (âOSMâ) in the Omnibus Autism Proceeding, which was established to manage the large number of claims brought by various petitioners alleging that vaccines caused their, or their childâs, autism or similar neurodevelopmental disorder. Moreover, it was selected to be one of three cases to test the first theory of causation advanced by the Omnibus Autism Proceeding petitioners.
The special masterâs decision contains a thorough recitation of both the factual and procedural history of this case. See Snyder, by & Through Snyder v. Secây of HHS, No. 01-162V, 2009 WL 332044 (Fed.Cl.Spec.Mstr. Feb. 12, 2009). Thus, for context purposes only, the court presents an abbreviated version here.
A. Factual History
Colten was born on January 9, 1997. Id. at *149. During the first fifteen months of his life, Colten âexhibited early signs of food allergies and asthma, in addition to a number of fevers and several gastrointestinal, respiratory, and throat infections.â Id. at *150. There was âan early sign of developmental delay followed by apparently normal developmentâ and evidence of âsome behaviors that, at least in retrospect, refleet[ed] areas of concern.â Id. at *149. Colten received his scheduled childhood vaccinations throughout this period.
On April 23, 1998, at age fifteen months, Colten received his first MMR vaccination during a well-child visit with his pediatrician. Id. at *151. At this visit, Colten appeared healthy and had âno signs of any receptive language disorders.â Id. at **151-52. However, on May 26, 1998, after visits to the emergency room on each of the prior two days, Colten was hospitalized with âfever, diarrhea, dehydration, gastroenteritis, and pharyngitis,â as well as â âmental-status type changes.â â Id. at **153-54 (quoting the relevant medical record). On his discharge on May 28,1998, Colten had a normal neurological examination and âwas behaving in an age-appropriate manner.â Id. at *155.
Between his hospitalization and his two-year well-child visit, Colten experienced several infections, in approximately the same pattern as the those he experienced prior to his MMR vaccination.
On July 28, 1999, Colten was seen by Dr. J. Jeffrey Bradstreet, id. at *163, âa family physician who has chosen to limit his practice to children withâ autism spectrum disorders and attention deficit hyperactivity disorder, id. at *21. One of Dr. Bradstreetâs initial diagnoses for Colten was autism. Id. at **163, 165. There is no evidence that Dr. Bradstreet used any of the accepted autism rating scales to reach this diagnosis. Id. at *163 n. 467. In contrast, less than a month later, a psychologist who evaluated Colten using the Childhood Autism Rating Seale diagnosed him with a pervasive developmental disorder, albeit ânot at the intensity or frequency of symptoms necessary to meet the diagnostic criteria for autistic disorder.â
Over the next eight years, Dr. Bradstreet continued to see Colten as a patient, treating him with âa wide variety of dietary supplements, secretin infusions, immunoglobulin therapy, chelation, glutathione, and prednili-sone.â Id. at *163 (footnote omitted); see also id. at **173-80 (describing the treatments in more detail). His recorded diagnoses varied over time, and, aside from autism, included autoimmune encephalopathy; autoimmune disease not elsewhere classified; unspecified disorder of immune mechanism; allergic gastroenteritis; autoimmune disease; unspecified urticaria; unspecified encephalopathy; gastroenteritis; colitis; disturbance of sulphur-bearing amino acid metabolism; unspecified disorder of metabolism; and toxic effect of mercury and its compounds. Id. at *163. Dr. Bradstreet also ordered a wide variety of tests during his treatment of Col-ten, including testing for the presence of measles viras in Coltenâs blood, cerebrospinal fluid (âCSFâ), and gut tissue. Id. See generally id. at **166-73 (describing the various tests in detail). Dr. Bradstreet sent the blood, CSF, and tissue samples to Unigenet-ies, a laboratory in Dublin, Ireland. Id. at **172-73. The laboratory reported that the CSF sample tested positive for measles virus, that the blood sample tested negative for measles virus, and that the gut tissue sample tested positive for the measles virus, albeit in a very low amount. Id.
In the years following his PDD-NOS diagnosis, Colten exhibited a marked improvement in his language skills. âAlthough Colten started the first grade classified as developmentally delayed and language impaired, at seven and one-half years of age, Coltenâs vocabulary and sentence structure was that of a nine year old.â Id. at *165 (citation omitted). In fact, âColten was released from the developmental delay classification on August 10, 2004.â Id. Although Coltenâs mother attributed Coltenâs improvement to the treatments prescribed by Dr. Bradstreet, see generally id. at **174-80, one of respondentâs experts ânoted that Coltenâs developmental pattern was consistent with the natural history of autismâ and that âColtenâs normal intelligence permitted him to benefit substantially from speech and language therapy,â id. at *181.
B. Procedural History
Petitioners filed a petition for compensation on March 22, 2001, alleging that Coltenâs April 3, 1998 MMR vaccination caused a âpost-vaccinal encephalopathy.â Pet. ¶ 9. The petition was filed before the July 3, 2002 creation of the Omnibus Autism Proceeding. See In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a Similar Neurodevelopmental Disorder (âAutism General Order # 1â), 2002 WL 31696785 (Fed.Cl.Spec.Mstr. July 3, 2002). Having clarified Coltenâs injury as a pervasive developmental disorder rather than the previously alleged âpost-vaccinal encephalopathy,â
As originally contemplated, petitioners in the Omnibus Autism Proceeding would present their evidence concerning all of their causation theories in a hearing before one special master, Special Master George L. Hastings. See id. at *3. Ultimately, however, it was determined that three special masters would consider the general causation evidence for each of petitionersâ theories,
The instant ease was designated as the third test case for petitionersâ first theory of causation (âTheory 1â) in June 2007. Order 1, June 25, 2007. As alluded to above, Theory 1 posits âthat a combination of the MMR vaccine and [thimerosal-containing vaccines], acting in concert, cause some [autism spectrum disorders].â Snyder, 2009 WL 332044, at *2. Shortly after the designation of this ease as a test case, during a twelve-day-long hearing spanning from June 11 to June 26, 2007, all three special masters assigned to the Omnibus Autism Proceeding heard testimony concerning petitionersâ first theory of causation.
II. DISCUSSION
The Court of Federal Claims has jurisdiction to review the record of the proceedings before a special master, and upon such review, may:
(A) uphold the findings of fact and conclusions of law of the special master and sustain the special masterâs decision,
(B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in accordance with the courtâs direction.
42 U.S.C. § 300aa-12(e)(2). In the instant case, petitioners enumerate, pursuant to Vaccine Rule 24(a),
*712 1. The Use of a Panel of Three Special Masters to Hear the âGeneral Causationâ Issue in Coltenâs Case Was Arbitrary, Capricious, an Abuse of Discretion, and Not in Accordance With the Law;
2. The Special Mastersâ Decision to Allow the Last-Minute Expert Reports and Testimony of Dr. Stephen Bustin Was Arbitrary, Capricious, and an Abuse of Discretion;
3. The Special Master Abused Her Discretion by Ignoring Concessions by the Respondentâs Expert Witnesses;
4. The Special Master Abused Her Discretion by Simply Ignoring Other Important Aspects of Petitioner[sâ] Evidence;
5. The Special Master Abused Her Discretion by Failing to Require That Dr. Rima Disclose Underlying Data and Facts Concerning His Opinions About the Reliability of the Unigeneties Laboratory;
6. The Special Master Abused Her Discretion by Refusing to Consider Significant Post-Hearing Evidence; and
7. The Special Masterâs Decision Was Not in Accordance With the Law.
Petârs Mem. Supp. Mot. Review Special Masterâs Decision Feb. 12, 2009 (âMot.â) 21-61. Before turning to petitionersâ numbered objections, however, the court discusses the role of special masters under the Vaccine Act, an issue implicated throughout petitionersâ motion for review. It then addresses each of petitionersâ numbered objections seri-atim and finally concludes with some comments concerning the complaints lodged by petitioners outside of the confines of their numbered objections.
A. Role of Special Masters
As mentioned above, several of petitionersâ objections to the special masterâs decision implicate the role of special masters in conducting proceedings and rendering decisions in Vaccine Act eases. Therefore, a discussion of their role is warranted. Congress, in creating the National Vaccine Injury Compensation Program (âVaccine Programâ), intended to address âthe inadequacy â from both the perspective of vaccine-injured persons as well as vaccine manufacturers â of the current approach to compensating those who have been damaged by a vaccine....â H.R.Rep. No. 99-908, at 7 (1986); accord id. at 12 (noting the twin goals of compensating those injured by vaccines without resort to a full-fledged tort system and decreasing the number of lawsuits against vaccine manufacturers). Thus, in the Vaccine Act, it crafted âa Federal âno-faultâ compensation program under which awards can be made to vaccine-injured persons quickly, easily, and with certainty and generosity.â Id. at 1. To accomplish these aims, Congress set forth a procedure in the Vaccine Act to decide claims that placed special masters on the front lines:
(2) A special master shall serve as an adjunct to the court and mayâ
(A) require such evidence as may be appropriate for the preparation of proposed findings of fact and conclusions of law with respect to whether compensation is to be provided under the Program and the amount of any such compensation,
(B) require the submission of such information as may be reasonable and necessary to determine if the petitioner is entitled to compensation,
(C) require the testimony of any person and the production of any document as may be reasonable and necessary to determine if the petitioner is entitled to compensation,
(D) conduct such hearings as may be appropriate, and
(E) prepare and submit to the court proposed findings of fact and conclusions of law.
_There may be no discovery in a proceeding on a petition other than the discovery required under this paragraph.
Congress also specified in the Vaccine Act what matters the special master should consider in rendering a decision on a petition:
(1) In determining whether to award compensation to a petitioner under the Program, the court shall consider, in addition to all other relevant medical and scientific evidence contained in the recordâ
(A) any diagnosis, conclusion, medical judgment, or autopsy or coronerâs report which is contained in the record regarding the nature, causation, and aggravation of the petitionerâs illness, disability, injury, condition, or death, and
(B) the results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.
Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the court. In evaluating the weight to be afforded to any such diagnosis, conclusion, judgment, test result, report, or summary, the court shall consider the entire record and the course of the injury, disability, illness, or condition until the date of the judgment of the court.
Id. at 3763 (codified as amended at 42 U.S.C. § 300aa-13(b)(l) (2006)). Congress elaborated in the House Report that special masters should âexercise [their] best judgment in evaluating whether the record satisfies the requirements for compensation.â H.R. Rep. No. 99-908, at 18.
In 1988, Congress amended the Vaccine Act to require, as opposed to permit, special masters to âprepare and submit to the court proposed findings of fact and conclusions of law.â Medicare Catastrophic Coverage Act of 1988, Pub.L. No. 100-360, § 411(o)(3), 102 Stat. 683, 808. Then, in its comprehensive amendment of the Vaccine Act in 1989, Congress formally established the OSM and reiterated the special mastersâ duties:
(3)(A) A special master to whom a petition has been assigned shall issue a decision on such petition with respect to whether compensation is to be provided under the Program and the amount of such compensation. The decision of the special master shallâ
(i)include findings of fact and conclusions of law....
(B) In conducting a proceeding on a petition a special masterâ
(i) may require such evidence as may be reasonable and necessary,
(ii) may require the submission of such information as may be reasonable and necessary,
(iii) may require the testimony of any person and the production of any documents as may be reasonable and necessary,
(iv) shall afford all interested persons an opportunity to submit relevant written informationâ
(I) relating to the existence of the evidence described in [42 U.S.C. § 300aa-]13(a)(l)(B), or
(II) relating to any allegation in a petition with respect to the matters described in section [42 U.S.C. § 300aa-]ll(e)(l)(C)(ii), and
(v) may conduct such hearings as may be reasonable and necessary.
*714 There may be no discovery in a proceeding on a petition other than the discovery required by the special master.
Omnibus Budget Reconciliation Act of 1989 § 6601(g)(2) (codified at 42 U.S.C. § 300aa-12(d)(3) (2006)). Congress once again elaborated on the nature of the proceedings before a special master in the Conference Report for the underlying bill: âThe system is intended to allow the proceedings to be conducted in what has come to be known as an âinquisitorialâ format, with the master conducting discovery (as needed), cross-examination (as needed), and investigation.â H.R.Rep. No. 101-386, at 87 (1989) (Conf. Rep.). To cement the importance of the role it intended special masters to perform, Congress added teeth to the special mastersâ decisions, providing that the United States Claims Court (âClaims Courtâ), the predecessor of the Court of Federal Claims, could set aside a special masterâs findings of fact or conclusions of law only if they were arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. Omnibus Budget Reconciliation Act of 1989 § 6601(h) (codified at 42 U.S.C. § 300aa-12(e)(2)(B) (2006)). It explained that it intentionally âprovided for a limited standard for appeal from the masterâs decisionâ and that it did ânot intend that this procedure be used frequently but rather in those cases in which a truly arbitrary decision has been made.â H.R.Rep. No. 101-386, at 87.
Also among the 1989 amendments to the Vaccine Act was a provision requiring the Claims Court to promulgate rales governing proceedings on vaccine petitions consistent with the purposes of the Vaccine Program:
(2) The special masters shall recommend rules to the Claims Court and, taking into account such recommended rules, the Claims Court shall promulgate rules pursuant to section 2071 of title 28, United States Code. Such rales shallâ
(A)provide for a less-adversarial, expeditious, and informal proceeding for the resolution of petitions,
(B) include flexible and informal standards of admissibility of evidence,
(C) include the opportunity for summary judgment,
(D) include the opportunity for parties to submit arguments and evidence on the record without requiring routine use of oral presentations, cross examinations, or hearings, and
(E) provide for limitations on discovery and allow the special masters to replace the usual rules of discovery in civil actions in the United States Claims Court.
Omnibus Budget Reconciliation Act of 1989 § 6601(g) (codified as amended at 42 U.S.C. § 300aa-12(d)(2) (2006)).
The Claims Court complied with this directive on March 15, 1991.
The special master shall be responsible for conducting all proceedings, including requiring such evidence as may be appropriate, in order to prepare a decision, including findings of fact and conclusions of law, determining whether an award of compensation should be made under the Vaccine Act and the amount of any such award. The special master shall determine the nature of the proceedings with the goal of making the proceedings expeditious, flexible, and less adversarial, while at the same time affording each party a full and fair opportunity to present its case and creating a record sufficient to allow review of the special masterâs decision.
Vaccine Rule 7 reiterated that there would be âno discovery as a matter of right,â and provided:
(a) Informal Discovery Preferred. The informal and cooperative exchange of information is the ordinary and preferred practice.
*715 (b)Formal Discovery. If a party considers that informal discovery is not sufficient, that party may seek to utilize the discovery procedures provided by RUSCC 26-36 by filing a motion indicating the discovery sought and stating with particularity the reasons therefor, including an explanation as to why informal techniques have not been sufficient. Such a motion may also be made orally at a status conference.
(e) Subpoena. When necessary, the special master upon request by a party may instruct the clerk ... to issue a subpoena for the taking of a deposition with or without the production of documents.
Vaccine Rule 8 governed the taking of evidence and argument:
(a) General. The special master in each case, based on the specific circumstances thereof, shall determine the format for taking evidence and hearing argument. The particularâ format for each case will be ordered after consultation with the parties.
(b) Evidence. In receiving evidence, the special master will not be bound by common law or statutory rules of evidence. The special master will consider all relevant, reliable evidence, governed by principles of fundamental fairness to both parties. Evidence may be taken in the form of documents, affidavits, oral testimony at a hearing in person or via telephone; or even, in appropriate circumstances, video tape. Sworn written testimony may be submitted in lieu of oral testimony.
(c) Argument. Argument may be received by telephone conference call or at a hearing or in written submissions. The special master may establish requirements for such filings, e.g., contents or page limitations, as appropriate.
(d) Decision Without Evidentiary Hearing. The special master may decide a case on the basis of written filings without an evi-dentiary hearing. In addition, the special master may decide a ease on summary judgment, adopting procedures set forth in RUSCC 56 modified to the needs of the case.
(e) Hearing. When necessary, the special master may conduct an evidentiary hearing. The special master will determine the format for such a hearing. The special master may permit testimony at such a hearing via telephone. The special master may permit direct examination of a witness or may permit or require that the direct testimony be submitted in written form. The special master may question a witness and may, on request, permit questioning by opposing counsel. The clerk, on request, may issue a subpoena requiring the attendance of a witness at such hearing.
The remaining Vaccine Rules crafted by the Claims Court, while providing a framework for Vaccine Program proceedings, did not directly implicate the broad role of the special masters.
Although the Vaccine Act has been amended on numerous occasions since 1989,
As early as 1991, the Federal Circuit acknowledged the congressionally mandated deferential standard of review accorded decisions of the special masters, noting that â[i]f the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.â Hines ex rel. Sevier v. Secây of HHS, 940 F.2d 1518, 1528 (Fed.Cir.1991). Indeed, held the Federal Circuit, âarguments as to the weighing of evidence, particularly where, as here, witness credibility is involved, do not demonstrate reversible error.â Id. at 1527. The following year, the Federal Circuit again acknowledged the âgreat deferenceâ owed the special masterâs findings and conclusions by a reviewing court, recognizing that â[w]ith regard to both fact-findings and fact-based conclusions, the key decision maker in the first instance is the special master.â Munn v. Secây of HHS, 970 F.2d 863, 870-71 (Fed.Cir.1992). Moreover, it emphasized that âthe probative value of the evidenceâ and âthe credibility of the witnessesâ were within the special masterâs purview as fact finder. Id. at 871.
The Federal Circuitâs adherence to the congressionally mandated standard of deference applicable to special masters has remained constant. For example, in Bradley ex rel. Bradley v. Secretary of HHS, it noted that the special master, as fact finder, had âbroad discretion in determining credibility because [the special master] saw the witnesses and heard the testimony.â 991 F.2d 1570, 1575 (Fed.Cir.1993). Similarly, in Bums, by Bums v. Secretary of HHS, it noted both that a special master âhad wide discretion in conducting the proceedings in a caseâ and that credibility determinations were âuniquely within the purview of the special master.â 3 F.3d 415, 417 (Fed.Cir.1993). In Hodges v. Secretary of HHS, the Federal Circuit explained:
Congress assigned to a group of specialists, the Special Masters within the Court of Federal Claims, the unenviable job of sorting through these painful cases and, based upon their accumulated expertise in the field, judging the merits of the individual claims. The statute makes clear that, on review, the Court of Federal Claims is not to second guess the Special Master[â]s fact-intensive conclusions; the standard of review is uniquely deferential for what is essentially a judicial process_That level of deference is especially apt in a case in which the medical evidence of causation is in dispute.
9 F.3d 958, 961 (Fed.Cir.1993). The deference standard was reiterated by the Federal Circuit in Whitecotton, by Whitecotton v. Secretary of HHS in its remark that âCongress desired the special masters to have very wide discretion with respect to the evidence they would consider and the weight to be assigned that evidence.â 81 F.3d 1099, 1108 (Fed.Cir.1996). And, in Lampe v. Secretary of HHS, it concluded that â[t]he arbitrary and capricious standard of review is difficult for an appellant to satisfy with respect to any issue, but particularly with respect to an issue that turns on the weighing of evidence by the trier of fact.â 219 F.3d 1357, 1360 (Fed.Cir.2000).
The pivotal role played by the special masters has also been recognized by the Court of Federal Claims.
[A] decision that reflects a reasoned evaluation of the evidence and that is otherwise free of legal error cannot be overturned. We have such a decision here. The special master confronted the task of choosing between two competing expert opinions by articulating a reasoned basisâ drawn from the evidence â for preferring one over the other. No more can be demanded.
37 Fed.CI. 723, 727 (1996) (citation omitted).
Several years later, in Sword v. United States,
As fact-finders, Special Masters, like juries, are often faced with the âbattle of the expertsâ when it comes to interpreting facts. And as fact-finders, they may find that truth lies somewhere in between the opposing, uncompromising views of the partisan experts. Expert opinion testimony is just opinion, and the fact-finder may weigh and assess that opinion in coming to her own conclusions. However, even more than ordinary fact-finders, this Court has recognized the unique ability of Special Masters to adjudge eases in the light of their own acquired specialized knowledge and expertise.... The Special Masterâs sole professional responsibility for years has been to preside over vaccine cases....
.... No judge or jury can be forced to accept or reject an expertâs opinion or a partyâs theory at face value. To require such a choice in this context is to neglect the Special Masterâs duty to âvigorously and diligently investigate the factual elementsâ underlying the petition.
The probative value of expert testimony surfaces indirectly in providing specialized knowledge with which the fact-finder may make rational inferences and reconcile the conflicting expert opinions. A fact-finder, especially one with specialized experience such as a Special Master, can accept or reject opinion testimony, in whole or in part. When the evidence is in, and it is time to apply the facts to the law, the expertâs role is over. Partisan testimony then gives way as the Special Master evaluates the testimony in light of the entire record, based on reasonable inferences born of common experience or the product of special expertise.... She did so in this case, weighing factors not present in the cold record â credibility and those other intangibles that lead reviewing courts to defer so greatly to the fact-finder who observed the witnesses and heard the evidence.
In exercising its jurisdiction pursuant to the Vaccine Act, the Court acts not as a trial court, but as a reviewing authority. That role does not lend itself easily to resolving differing accounts of causation or other factual disputes, nor to weighing the credibility and strength of testimony. The Special Master, by contrast, heard all of the evidence first-hand and was afforded the opportunity to question the witnesses*718 and evaluate their credibility and persuasiveness. She was, therefore, best able to steer a course through the divergent opinions in this case.
44 Fed.Cl. 188, 188-89 (1999) (citations omitted). In Ryman v. Secretary of HHS, the court explained that a special master performs a gate-keeping function âwhen he determines whether a particular petitionerâs expert medical testimony supporting biologic probability may be admitted or credited or otherwise relied upon,â 65 Fed.Cl. 35, 40 (2005), but also acts as âa trier-of-fact and therefore may properly consider the credibility and applicability of medical theories,â id. at 41. Finally, in Doe v. Secretary of HHS, the court stated:
Instead of being passive recipients of information, such as jurors, special masters are given an active role in determining the facts relevant to Vaccine Act petitions. One reason that proceedings are more expeditious in the hands of special masters is that the special masters have the expertise and experience to know the type of information that is most probative of a claim.
76 Fed.Cl. 328, 338-39 (2007); accord Hines ex rel. Sevier v. Secây of HHS, 21 Cl.Ct. 634, 648 (1990) (âThe Special Master is not required to be a âpotted plantâ at the hearing ....â), aff'd, 940 F.2d at 1518.
In sum, when considering the provisions and legislative history of the Vaccine Act, the language of the Vaccine Rules, and the case law, one factor that has remained constant in the Vaccine Program is the necessary and important role of special masters in conducting proceedings and rendering decisions in Vaccine Act cases. The special masters have great leeway in how they conduct proceedings, including what evidence to consider and how to weigh that evidence, and their credibility determinations and fact-intensive conclusions are afforded great deference. However, this is not to suggest that the special masters are infallible and that their final decisions are sacrosanct. To be sure, the Court of Federal Claims on review, and the Federal Circuit on appeal, do not merely rubber stamp special master final decisions.
B. Petitionersâ First Numbered Objection: Using a Panel of Three Special Masters to Hear the âGeneral Causationâ Issue
The courtâs exploration of the role of special masters in the Vaccine Program is
As noted above, it was determined that three special masters would consider the general causation evidence for Theory 1 and that each special master would then apply the general causation evidence, along with the case-specific evidence for his or her individually assigned test ease, in rendering a decision. At the time that the eases were first apportioned among the three special masters, with one-third of the eases retained by Special Master Hastings and the remaining eases divided between Special Masters Vowell and Campbell-Smith, petitioners objected, âstating that âmultiple decisions by multiple Special Masters addressing nearly identical issues of law, fact, science and medicine ... will generate significant confusion and delay at the appellate level, further slowing the progress towards resolving claims in the omnibus.ââ Id. (quoting petitionersâ February 26, 2007 written objection). Notwithstanding petitionersâ objection, the Chief Special Master, on behalf of the OSM, explained in his Notice Regarding Reassignment that, âafter much thought and discussion with the other special masters,â he was assigning two additional special masters to facilitate the expeditious resolution of all of the cases in the Omnibus Autism Proceeding. Notice Regarding Reassignment 2. He noted that the final resolution of all of the cases would require rulings from the Federal Circuit because only the Federal Circuitâs binding precedent could provide the OSM with the ability to resolve the cases with âspeed, consistency, and certainty.â.
The reasoning behind the Chief Special Masterâs decision to assign three special masters to the Omnibus Autism Proceeding was further amplified in the January 19, 2007 Autism Update, where Special Masters Hastings, Campbell-Smith, and Vowell explained that (1) because it would be âhighly unlikely that a single special master would ever be able to finally dispose of nearly 5,000 separate individual eases, ... it seems that now is the appropriate time to get additional special masters involvedâ; (2) âin the overall scheme of the Vaccine Act, to have more than one special master hear the general causation evidence and offer an evaluation of the general causation issueâ would alleviate concerns that âthe fate of so many families
The special masters have wide discretion to conduct proceedings in a manner which, in their individual judgment, best facilitates their ability to render a decision in a particular case. See 42 U.S.C. § 300aa-12(d)(3)(B) (indicating that special masters âmayâ require evidence, information, testimony, or hearings, and that special masters have complete control over discovery); Vaccine Rule 8(a) (âThe special master will determine the format for taking evidence and hearing argument based on the specific circumstances of each ease and after consultation with the parties.â); Burns, 3 F.3d at 417 (noting that the special master âhad wide discretion in conducting the proceedings in a caseâ); Doe, 76 Fed.Cl. at 338-39 (âOne reason that proceedings are more expeditious in the hands of special masters is that the special masters have the expertise and experience to know the type of information that is most probative of a claim.â); Sword, 44 Fed.Cl. at 190 (âOn a more fundamental level, judicial officers conducting evidentiary hearings â trialsâare afforded great latitude on how they administer the proceedings in their forum.â). Here, the special masters determined that the interests of petitioners would best be served by having three special masters hear the general causation evidence and then apply that evidence to the individual cases. The court finds no error in that decision.
Further, petitionersâ contention that they were required to prove their case to all three special masters lacks merit. Although all three special masters heard and considered the general causation evidence, they issued separate decisions applying that evidence to their respective test case. See Snyder, 2009 WL 332044; Hazlehurst ex rel. Hazlehurst v. Secây of HHS, No. 03-654V, 2009 WL 332306 (Fed.Cl.Spec.Mstr. Feb. 12, 2009); Cedillo ex rel. Cedillo v. Secây of HHS, No. 98-916V, 2009 WL 331968 (Fed.Cl.Spec.Mstr. Feb. 12, 2009). The special masters were free to reach different conclusions based on the same evidence.
C. Petitionersâ Second Numbered Objection: Allowing the Submission of Expert Reports of Dr. Stephen Bustin
In them second numbered objection, petitioners argue that the special masters, and, necessarily, the special master in this case, should not have allowed respondentâs submission of two expert reports and testimony from Dr. Stephen Bustin, arguing that they were prejudiced by the âlast-minuteâ nature of the evidence. Some procedural background is necessary to place petitionersâ objection in proper context.
On February 13, 2007, the three special masters set deadlines for the partiesâ expert reports concerning both the general causation issues and the specific causation issues in Cedilla â petitionersâ expert reports were due on February 9, 2007, and respondentâs expert reports were due on April 24, 2007. Snyder, 2009 WL 332044, at *22. Petitioners filed four expert reports on their deadline. Id. at *23. âAfter receipt of these expert reports, respondentâs litigation team began identifying and interviewing potential expert witnesses. By mid-March, it became apparent that the laboratory results from Unigen-etics were a key feature in petitionersâ case.â
On April 24, 2007, respondent filed eleven expert reports in Cedillo addressing general causation issues, including one from Dr. Brian Ward that addressed publicly available information regarding Unigeneties. Oral Argument Tr. 45. About two weeks later, Special Master Hastings directed the parties âto file all documentary evidence, including medical literature, by May 25, 2007.â Id. On May 22, 2007, more than three months past their deadline and without leave of court, petitioners filed an additional expert report addressing the techniques utilized by the Un-igeneties laboratory. Id. at *20,23. On May 31, 2007, respondent filed an expert report prepared by Dr. Bustin that responded to
In the meantime, in early May 2007, after determining that âseveral of petitionersâ experts in Cedillo had also served as expertsâ in the U.K. MMR litigation, respondent âdecided to attempt to obtain their reports and some evidence pertaining to Unigeneticsâ testingâ from the court in the United Kingdom. Id. Respondent made a formal application to the High Court of Justice, Queenâs Bench Division, for the release of those documents on May 18, 2007, requesting an expedited hearing. Id. Respondent informed petitioners of his application on May 22, 2007, at which time petitioners requested only that respondent share whatever he obtained from the United Kingdom court.
Petitioners complain that the filing of Dr. Bustinâs âhighly technicalâ reports from the U.K. MMR litigation âon the eve of trialâ and the submission of Dr. Bustinâs âimpossibly technical power-point [sic] presentation at the hearingâ were âgrossly unfairâ because counsel for the Cedillo petitioners had âno time to review the documents, let alone prepare for erossexamination.â
At the November 2007 hearing, the special master encouraged âpetitioners to proceed with speed and diligenceâ in their attempt to obtain the material and respondentâs counsel reiterated their support of petitionersâ effort. Id. at **25-26. âBetween November, 2007, and July, 2008, the special masters repeatedly raised the issue of petitionersâ attempts to obtain additional evidence from the U.K. MMR litigationâ during status conferences. Id. at *26. They even âsigned a letter indicating [their] support for release of the documents sought by petitioners.â Id. Yet, â[a]t no point didâ petitioners âindicate that an application had actually been made.â Id. âUltimately, based on the delay and expense that would be involved in litigating the release of some reports without the consent of the experts, [petitioners] chose not to seek the release of any of the additional expert reports.â Id. Accordingly, the special master closed the evidentiary record on July 31, 2008.
Based on the preceding procedural history, it is clear to the court that petitioners have no basis to complain about the special master admitting Dr. Bustinâs expert reports into the record. It was not until February 2007 â when petitioners filed their expert reports â that respondent could have
Moreover, as previously described, the special master afforded petitioners ample opportunity to respond to the contents of Dr. Bustinâs reports once the Cedillo hearing had concluded. She, along with the two other special masters, repeatedly queried petitioners about their efforts to obtain additional information from the U.K. MMR litigation, encouraged petitioners to obtain the information, and offered to join in petitionersâ application for the release of the information from the court in the United Kingdom. There were almost five months between the Cedillo and Snyder hearings, eight months between the Snyder hearing and the close of the evidentiary record, and six months between the close of the evidentiary record and the special masterâs issuance of a decision. Thus, petitioners had approximately nineteen months within which to obtain whatever information they believed necessary to respond to Dr. Bustinâs expert reports and testimony. Given this extraordinary amount of time to secure any additional information, petitionersâ claim of prejudice fails. The special masterâs conclusion to this effect, see Snyder, 2009 WL 332044, at *27, was not arbitrary, capricious, or an abuse of discretion. Petitionersâ second numbered objection is rejected.
D. Petitionersâ Third and Fourth Numbered Objections: Ignoring Evidence
Petitioners next argue, in their third and fourth numbered objections, that the special master disregarded evidence relevant to their ease. In their third objection, they contend that the special master âignorefd] the many concessions of the respondentsâ experts,â
Immediately problematic is that petitioners do not explain how the special masterâs alleged failure to consider certain evidence would have altered her decision.
1. Petitionersâ Theory of Causation
To place petitionersâ specific contentions in context, a brief discussion of their theory of causation is appropriate. Petitioners presented them theory to the special master in the following manner:
(1) the ethylmercury in [thimerosal-con-taining vaccines] is an immune suppressant; (2) the attenuated measles virus contained in the MMR vaccine is an immune suppressant; (3) the combined effect of both [thimerosal-eontaining vaccines] and the measles vaccine virus suppressed the immune system of at least some children who received both; (4) this immunosup-pression permits the measles virus to persist in these children; (5) a persistent measles virus can enter the brain and cause a neurological injury; and (6) that neurological injury can include autism or [autism spectrum disorder] symptoms.
Snyder, 2009 WL 332044, at *28. In their motion for review, petitioners articulate how this theory of causation applies to Coltenâs case:
(1) [Colten] was born healthy; (2) he had normal development and met all milestones; (3) he received all required child vaccinations, including 12 vaccines that contained ethyl mercury; (4) the mercury damaged his immune system; (5) the MMR vaccine she [sic] received at 14[sic] months further damaged his immune system; (6) he was unable to clear the vaccine-strain [measles virus] contained in the MMR vaccine due to his immune deficiency; (7) the [measles virus] persisted and replicated in Colten; (8) the [measles virus] caused her [sic] to suffer [inflammatory bowel disease]; and (9) the [measles virus] entered his brain, causing inflammation and autism.
Mot. 17. However, as explained by the special master, the medical theory advanced by petitionersâ testifying experts does not conform to this framework.
Dr. Kinsbourne, petitionersâ expert in pediatric neurology, was âthe pivotal petitionersâ witness on causation ..., providing the theories upon which the causation cases were based.â Snyder, 2009 WL 332044, at *11. According to the special master:
He âconnected the dotsâ in the general causation case among Dr. Byersâ opinions on immunology and immune functioning in [autism spectrum disorder], Dr. Kennedyâs opinions on virology and measles virus persistence, Dr. Krigsmanâs opinions on gas-troenterology and gut disorders in [autism spectrum disorder], and Dr. Aposhianâs opinions on mercury toxicology and the role of [thimerosalcontaining vaccines] in [autism spectrum disorder].
Id. at *87. She explained Dr. Kinsbourneâs hypothesis as follows:
[D]ue to an ineffective immune response, some children with regressive autism are unable to clear the measles vaccine virus from their bodies. The virus inhabits the gut, and is transported by macrophages through the circulatory system to the brain. After crossing the blood-brain barrier, the virus invades the astroglia, neurons, and possibly microglia, invoking a response by the brainâs innate immune system, the microglia. The microglia produce proinflammatory cytokines, causing brain inflammation. This inflammation disorganizes critical circuits in the brain, interrupting communication among various areas of the brain. These disorganized circuits manifest in autistic symptoms.
Alternatively, or additionally, ... the immune response to the measles virus caused gliosis, or scarring, of astrocytes (a type of glial cell sometimes referred to as*726 astroglia). One function of astrocytes is to mop up excess glutamate at the synapses, the bridges between neurons. Damaged or destroyed astrocytes may not perform this function properly, resulting in over-activation of the brain. Excess glutamate, the brainâs most prevalent excitatory neurotransmitter, can kill neurons and can cause an imbalance between excitatory and inhibitory neurotransmitters.
Id. at *77 (footnote & citations omitted). Notably, Dr. Kinsbourne âdid not rely on the theory of mercury dysregulation of Coltenâs immune system,â id. at *183, contending that the damage done to Coltenâs immune system was done solely by the MMR vaccine, id. at *184. In fact, the special master explained that â[t]he only witness who testified that Coltenâs immune system was dysregulated prior to his MMR vaccinationâ was Dr. Kennedy, a virologist, id. at *9, but â[w]hen informed that Dr. Bradstreet had testified that Coltenâs immune system was not dy-sregulated prior to the receipt of the MMR vaccine, Dr. Kennedy deferred to his assessment.â Id. at *166 n. 481. Thus, petitionersâ theory of causation depended upon, among other things, Coltenâs immune system being damaged by the MMR vaccine (but not thim-erosal-eontaining vaccines), the persistence of the measles virus in Coltenâs body, Coltenâs development of inflammatory bowel disease, and the presence of the measles virus in Coltenâs brain. With this background, the court proceeds to petitionersâ contentions.
2. Dr. Diane Griffin
Petitioners begin by describing a number of statements that Dr. Griffin either made or with which she concurred, which the special master purportedly ignored. These statements include: (1) âmeasles is one of the most infectious of all viral diseasesâ; (2) âa âtarget organâ of the measles virus is the gastrointestinal tractâ; (3) âthe attenuated measles vaccine can cause progressive fatal respiratory disease or neurological disease in immunocompromised individualsâ; (4) âmeasles virus affects many components of the immune systemâ; (5) âmeasles virus causes immunosuppression that continues for months after the period of viremiaâ; (6) âmeasles virus skews T cells, and ... when Thl and Th2 are not in balance the bodyâs ability to clear viruses will be impairedâ; (7) âthe measles vaccine, like the wild virus, causes lymphopeniaâ; (8) âyou can definitely identify changes [in antibodies] that are occurring as part of the induction of the immune response to the vaccineâ; (9) âmeasles can cause neurologic diseaseâ; (10) âthe risk of viral persistence increases in an immuno-suppressed personâ; (11) âviruses can persist in the human bodyâ; (12) âthe PCR technique used by [Unigenetics] is commonly used to detect viral RNAâ;
Notwithstanding petitionersâ representations, the special master addressed each of these assertions in her decision. See, e.g., Snyder, 2009 WL 332044, at *95 (â[Measles] is one of the most infectious viruses known_It spreads to gut tissue-â), 96 (âThe period of immunosuppression begins at 9-15 days after exposure to the virus, and continues for approximately two to three months after recovery from measles disease.â), 97 (noting a âskewing of the immune system to a Th2 responseâ after a measles infection), 98 (noting that âthe measles vaccine virusâ causes âa period of immunologic abnormalitiesâ that are âcoincident with inducing the immune response to measlesâ), 99 (âFollowing measles immunization, transient Th2 skewing occurs.... The vaccine virus also results in transient lymphopenia.â), 105 (âMeasles vaccine virus may cause or con
Petitioners also allege that the special master ignored conflicting evidence from Dr. Griffin concerning whether the presence of measles virus RNA means that the measles virus is replicating.
As a threshold matter, the court cannot see the relevance of petitionersâ contentions with respect to this issue. The special master concluded that if there indeed was measles virus RNA detected in Coltenâs CSF, then one must conclude that the virus had to be replicating. See, e.g., Snyder, 2009 WL 332044, at * 188 (âIf reliable, the report of measles virus RNA in Coltenâs CSF would be strongly probative that there was an ongoing persistent measles infection in Coltenâs brain. If rehable, the report of measles virus RNA in Coltenâs gut would be probative of the âautistic enterocolitisâ disease process ..., and the gut-brain connection would provide the linkage between measles virus persisting in the gut and neurologic dysfunctions manifesting as autism.â), id. at *189 (âMeasles virus, like other RNA viruses, must replicate constantly in order to survive. If no antibodies are present to fight the virus, it can replicate virtually unchecked. Thus, if measles virus were actually present in Coltenâs brain, but he was not manufacturing any antibodies against it, the results would be incompatible with Coltenâs continued life or health.â (citation omitted)). Thus, she appears to concur with petitionersâ position that the presence of measles virus RNA in Col-tenâs body would demonstrate replication.
Finally, although the special master discussed an enormous quantity of evidence in her decision, she does not appear to have specifically addressed the alleged conflict (if there is an actual conflict) between Dr. Griffinâs testimony and Dr. Griffinâs article. At worst, this is harmless ei'ror, especially given the special masterâs representation that she had considered all of the evidence in the record. See id. at *7-8. The special master was not required to discuss every piece of evidence or testimony in her decision. Maza, by Maza v. Secây of HHS, 67 Fed.Cl. 36, 38 (2005) (âThe Special Master need not discuss every item of evidence in the record so long as her decision makes clear that she considered the petitionersâ arguments.â); Moreno v. Secây of HHS, 65 Fed.Cl. 13, 26 (2005) (â[I]t does not necessarily follow that the Special Master must issue a finding on every bit of minutiae that guides his findings as to credibility, so long as there is support in the record for his conclusions.â); Snyder by Snyder v. Secây of HHS, 36 Fed.Cl. 461, 466 (1996) (âThe special master need not discuss every item of evidence in the record so long as the decision makes clear that the special master fully considered a partyâs position and arguments on point.â), aff'd, 117 F.3d 545 (Fed.Cir.1997); Murphy ex rel. Murphy v. Secây of HHS, 23 Cl.Ct. 726, 734 n. 8 (1991) (âThe special master is not required to discuss every item of evidence when his decision reflects that he fully considered a partyâs position and arguments on point.â), aff'd per curiam, 968 F.2d 1226, 1992 WL 90552 (Fed.Cir.1992) (mem.). Nevertheless, here, the court finds no error.
3. Dr. Brian Ward
Next, petitioners claim that the special master ignored the following statements that Dr. Ward either made or with which he concurred:
As with the statements made, or agreed to, by Dr. Griffin, the special master addressed each of these topics in her decision. See, e.g., Snyder, 2009 WL 332044, at *10 (noting that Dr. Oldstone was a âwidely recognized expert in virology and in the study of measlesâ), *96 (âIn measles infections, the immune system is actively involved in fighting the measles virus, and does not respond normally to other pathogens. Thus, most measles-related deaths are the result of ... opportunistic infections, rather than from the measles disease itself.â), *97 (âThe time frame in which the Th2-deviated response occurs would roughly correspond to the period of maximum viremia after infection with the measles virus.â), *99 (âFollowing measles immunization, transient Th2 skewing occurs.â), *104 (âThe skin rash occurs between nine and fifteen days after infection, marking the peak level of virus in the body, known as the period of maximum viremia.â), *106 (â[T]he diseases caused by replicating viruses are often new and unexpected.â), *106 & nn. 337-38 (citing Dr. Ward for the fact that âDr. Michael Oldstone [is] one of the worldâs most highly regarded virologistsâ and discussing
4. Dr. Robert Fujinami
Petitioners next argue that the special master ignored evidence supplied by Dr. Fu-jinami. As a preliminary matter, petitioners complain that because respondent failed to call Dr. Fujinami to testify, they lacked any opportunity to cross-examine him on the contents of his expert report.
5. Unigeneties
Petitioners next allege that the special master ignored a plethora of evidence concerning the reliability of test results from Unigeneties. As a preface to addressing petitionersâ contentions, a brief summary of the special masterâs conclusions on this topic is in order. As alluded to above, respondent mounted a vigorous attack against the reliability of the laboratory results from Un-igenetics. The evidence regarding the laboratoryâs reliability came from both publicly available information and documents obtained from the U.K. MMR litigation. Snyder, 2009 WL 332044, at * 116. Because the petitioners in Cedillo and Hazlehwrst moved to strike the evidence derived from the U.K. MMR litigation,
[A]n analysis of the public evidence alone clearly demonstrates that the results from Unigeneties cannot be relied upon as evidence of the persistence of measles virus in children with autism. When considering the U.K litigation information, the evidence that Unigenetiesâ results are not reliable is overwhelming. Unigenetiesâ operations reflect unsound applications of the sound scientific process of PCR testing.
Id. (emphasis added); accord id. at *189. Accordingly, the special masterâs consideration of the U.K. MMR litigation documents forms the basis for an alternative holding; her conclusion that the laboratory results from Unigeneties were unreliable does not depend on them. Petitionersâ assertions concerning the evidence regarding the reliability of the Unigeneties laboratory results described below implicate both of the special masterâs holdings.
a. Dr. Stephen Bustin
Petitionersâ first contention to support the reliability of the laboratory results from Uni-genetics centers upon the copy numbers derived during its PCR testing and Dr. Bustinâs opinion relative to those copy numbers. As explained by the special master, PCR testing âis a method of exponentially replicating a strand of DNA,â where âextremely small quantities of DNA can,be amplified, creating enough DNA to produce a visible âbandâ on a gel.â Id. at *110. Specifically, a primer (i.e., a complementary strand of DNA) is selected, the target strand DNA is split by heating,
Petitioners generally assert that the special master ignored testimony from Dr. Bus-tin that suggested that his lone objection to the results from Unigeneties was to the low copy numbers. Mot. 34-37. In making this contention, petitioners aver: âHigh copy numbers are considered accurate because the detection of RNA occurs at a lower cycle number, in other words, earlier in the experiment, and makes them inherently reliable.â Id. at 34-35; accord id. at 37. However, the special master, citing various portions of hearing testimony, expressly noted that â[e]ven when the copy numbers were high, the high values could reflect contamination rather than high amounts of the target substance in tissueâ and that â[a] high copy number of measles virus does not necessarily imply that the threshold cycle (CT) was low.â Snyder, 2009 WL 332044, at *135. Although they acknowledge Dr. Bustinâs testimony that a high copy number could reflect contamination, petitionerâs contend that the special master ignored the contrary testimony of Dr. Karin Hepner.
Petitioners also assert that the .special master disregarded Dr. Bustinâs hearing testimony about Dr. Finbar Cotterâs effort to replicate Unigenetiesâ results, including his ability to replicate results at high copy numbers, which they assert proves that the results were reliable. Mot. 34-35, 38-39. First, the special master clearly addressed this evidence â she devoted an entire section to it. See Snyder, 2009 WL 332044, at **132-33 (containing a section titled â(6) Reproducibility of Unigenetiesâ Results in U.K. MMR Litigationâ). Second, because Dr. Cotterâs testing was performed âwithin the context of the U.K. MMR litigation,â the special master considered this testimony within her alternative analysis, which addressed the publicly available information concerning Unigeneties along with the information derived from the U.K. MMR litigation. See id. Thus, to the extent that there is error in the special masterâs analysis, such error would be harmless because her primary reliability holding excluded, and thus there was no reliance upon, the U.K. MMR litigation evidence.
Finally, petitioners claim that the special master ignored the limited utility of the laboratory notebooks from Unigeneties relied upon by Dr. Bustin.
b. Dr. Michael Oldstone
Next, petitioners contend that the special master disregarded the contents of a letter authored by Dr. Oldstone, which they claim supports their case. Mot. 35. In fact, Dr. Oldstone wrote the letter to counter petitionersâ reliance on his research and to explain his experience with Unigeneties. Thus, petitionersâ complaint lacks merit on several grounds. First, petitionersâ contention that the special master ignored the letter is entirely inaccurate, as she clearly discussed both aspects of Dr. Oldstoneâs letter in her decision. See Snyder, 2009 WL 332044, at *106 (discussing petitionersâ reliance on Dr. Oldstoneâs research), **123-24 (containing a section titled â(5) Doctor Oldstoneâs Experienceâ). Second, petitioners, through the use of selective quotation, completely misrepresent the contents of the letter. Petitioners represent that Dr. Oldstoneâs letter reflects his belief in the reliability of results from Unigeneties, characterizing his view as follows:
In his letter, Dr. Oldstone revealed â[i]n the early 2000sâ he reviewed the [Unigen-etics laboratoryâs] protocols for detecting measles virus with PCR, and found them âto be sound.â In addition, Dr. Oldstone stated, [Unigenetiesâ] test results agreed with his own in 80% of the samples he sent to the [Unigeneties] lab.
The results of the second round were no better with again approximately 20% of the samples misidentified_46 Most troublesome, some samples, when tested twice under different code numbers[,] âswitchedâ from positive to negative or from negative to positive. On the basis of the inaccuracies of their PCR test, I declined from further working with [Unigenetics].
Id. (footnote & emphasis added). Thus, it is clear that the results from the second round of testing caused Dr. Oldstone to lose faith in the soundness and reliability of testing done by Unigenetics.
Most egregious is petitionersâ suggestion that Dr. Oldstoneâs letter included statements not actually contained in the letter. They assert: âDr. Oldstone also indicated that there was concordance between the two laboratories on high copy numbers. In other words, the high copy numbers detected by the [Unigenetics] primers were confirmed by the Oldstone laboratory using its primers.â Mot. 35; accord id. at 40. Nothing in Dr. Oldstoneâs letter even approximates this assertion, and petitioners provide no citation to the record where it might otherwise be located.
c. Dr. Bertus Rima
Petitionersâ next contentions concern the testimony of Dr. Rima. They first claim that the special master ignored testimony that countered Dr. Rimaâs assertion, repeated by Dr. Griffin and described by the special master, that the âextremely high copy numbersâ of measles RNA found in Coltenâs CSF âwere not biologically plausible.â Snyder, 2009 WL 332044, at *190. According to petitioners, Dr. Kennedy testified to a plausible explanation for the high copy numbers with which neither Dr. Rima nor Dr. Griffin disagreed. Mot. 40. However, there is no question that the special master considered the issue of copy numbers that were too high and
Petitioners also claim that the special master disregarded Dr. Rimaâs testimony concerning both measles virus replication and Unigeneticsâ use of immunohistoehemistry. Mot. 35-36; cf. id. at 42 (describing Dr. Griffinâs lack of awareness of the alleged immunohistochemieal testing). Once again, the special master discussed both of these topics in her decision. See, e.g., Snyder, 2009 WL 332044, at *95 (âThe measles virus is a single-stranded RNA virus. RNA viruses are unstable, and need to replicate constantly in order to maintain themselves.â (footnote &âą citations omitted)), 95 n. 299 (noting âDr. Rimaâs testimony that the virus must continue to replicate in order to surviveâ), 106-07 (indicating that in cases of subacute scleros-ing panencephalitis (âSSPEâ), the measles virus persists and replicates for seven to ten years after infection), 109 n. 350 (discussing the conflicting evidence about whether Uni-genetics performed immunohistochemieal testing), 117 & n. 356 (discussing the Uhl-mann paper and its ambiguous reference to immunohistochemieal testing). It does not matter that the special master may not have attributed the assertions to Dr. Rima or indicated that Dr. Rima concurred with them â it is clear that she considered the statements, or the underlying ideas represented by the statements.
Finally, petitioners insist that the special master ignored both Dr. Rimaâs testimony and their own âdirect evidenceâ that Unigen-etics used allelic discrimination to positively identify vaccine strain measles RNA in Col-tenâs samples.
d. General Statements about PCR tests
Finally, petitioners briefly argue that the special master ignored evidence regarding proper PCR testing procedures, including the use of controls, the prevention of contamination, and the prevalence of contamination. Mot. 37-38. This is obviously not the case. The special master carefully described how PCR testing is performed, and addressed both controls and contamination extensively. See, e.g., Snyder, 2009 WL 332044, at *110-15 (containing a detailed section titled â3. Polymerase Chain Reaction,â describing how the test is performed, how the results are confirmed, and typical problems with the test), 114 (âContamination is frequent even in the most compulsively monitored laboratories.â), 116-36 (applying the discussion of PCR testing to the Unigeneties results).
Altogether, there is no indication that the special master ignored the evidence cited by petitioners regarding the reliability of the test results from Unigenetics when rendering her decision.
6. Neuroinflammation
Petitioners next contend that the special master disregarded evidence demonstrating that measles caused Coltenâs neuroinflamma
Petitioners also argue that the special master ignored the contents of an article written by Dr. Oldstone. Mot. 44-46. They never explain the relevance of this article to neu-roinflammation, and none of the quotations they provide discuss neuroinflammation. To the extent that the article is relevant to the issue at hand, there is no question that the special master read and considered the article. See, e.g., Snyder, 2009 WL 332044, at *106 (noting that Dr. Oldstoneâs article was âread repeatedly into the recordâ and that âthe general statementsâ in the article âhardly constitute evidence that the measles virus actually persists to cause autismâ).
7. Mercury and Immune System Dysfunction
Petitionersâ final allegations that the special master disregarded evidence concern the relationship between mercury and immune system dysfunction. Mot. 46-49. In this regard, they make the following claims: (1) petitionei's ârelied on evidence presented in Cedillo that the mercury contained in numerous vaccines received by Colten affected his immune system and allowed measles to persist in his CSF long after it should have been eliminated from his bodyâ; (2) the special master found that petitioners had not demonstrated âmercury induced immune dysfunctionâ in Coltenâs case; and (3) the special master ignored the evidence that contradicted this finding. Id. at 46. All three claims are flawed.
With respect to petitionersâ first claim, the special master found no credible evidence that Coltenâs immune system was dysregulat-ed prior to receiving the MMR vaccination. See Snyder, 2009 WL 332044, at *166 n. 481. Additionally, petitionersâ main expert on causation, Dr. Kinsbourne, âdid not rely on the theory of mercury dysregulation of Coltenâs immune system,â and instead contended that the damage done to Coltenâs immune system was done by the MMR vaccine. Id. at **183-84. And, the special master concluded that there was no âexcess mercury in Col-tenâs body.â Id. at *169. None of these findings is contested by petitioners. Thus, petitionersâ reliance upon the effect of the mercury contained in the vaccines received by Colten is misplaced. They have no basis to assert that âthe mercury contained in numerous vaccines received by Colten affected his immune system.... â Mot. 46.
8. Conclusion Regarding Petitionersâ Third and Fourth Numbered Objections
In sum, far from disregarding the statements and various subject matter cited by petitioners, the special master both considered them and assigned them the weight that she felt appropriate.
E*. Petitionersâ Fifth Numbered Objection: Failing to Require That Dr. Rima Disclose Underlying Data and Facts Concerning His Opinions
In their fifth numbered objection, petitioners argue that the special master improperly âallowed Dr. Rimaâs opinion testimony concerning the reliability of the Unigenetics Laboratory without also requiring that he disclose the underlying facts and data he relied on.â Mot. 50. Petitioners explain that Dr. Rimaâs expert testimony âwas informed, in large part, by what he described as his review of laboratory notebooks, logs, and data generated in the course of work by Unigenetics and made available to him to examine in the United Kingdom,â but that these documents and data were not disclosed to them before or during Dr. Rimaâs testimony. Id. Petitioners make two broad contentions: first, that the special master should have applied the general framework of the
As a threshold matter, the court would be remiss if it did not highlight the fatal flaw in petitionersâ argument. As noted above, the special master concluded that Unigeneticsâ results were unreliable, reaching that conclusion using two different analyses: the first by considering only the publicly available evidence and the second by adding consideration of the evidence derived from the U.K. MMR litigation. See Snyder, 2009 WL 332044, at **116, 189. The unadmitted evidence that petitioners complain about here is only relevant to the special masterâs second, alternative analysis; it has no bearing on the first. Because petitioners have not objected to the primary holding of unreliability, based only upon the publicly available information, any error made by the special master in not requiring the disclosure of Dr. Rimaâs underlying data would be harmless.
However, the special master did not err. First, petitionersâ reliance upon the rules of evidence and civil procedure is misplaced. In most cases before the Court of Federal Claims, parties utilizing expert testimony are required to submit a written report from the expert, along with, among other things, âthe data or other information considered by the witness in formingâ his or her opinions. RCFC 26(a)(2)(B). The expert may then testify to his or her opinions âwithout first testifying to the underlying facts or data, unless the court requires otherwise.â Fed.R.Evid. 705. The opposing party, however, may seek the disclosure of the underlying facts or data on cross-examination. Id. Of course, these rules do not apply to proceedings in the Vaccine Program. Rather, as dictated by Congress in the Vaccine Act, â[tjhere is no discovery as a matter of right,â Vaccine Rule 7(a), and special masters are not âbound by common law or statutory rules of evidence,â Vaccine Rule 8(b)(1). See 42 U.S.C. § 300aa-12(d)(3)(B). Acknowledging this fact, petitioners assert that the more formal rules are part of the âgeneral frameworkâ for evaluating and weighing expert testimony that the special master applied elsewhere in her decision. Mot. 52. They contend that because the special master applied â[Federal Rule of Evidence] 702 and the body of case law under that Rule in weighing evidence in this case,â she should have also applied RCFC 26(a)(2)(B) and Federal Rule of Evidence 705. Id.; accord Oral Argument Tr. 22-24.
In her decision, the special master made only one direct reference to Federal Rule of Evidence 702:
In courts that apply the Federal Rules of Evidence, it is doubtful that some of petitionersâ expert witnesses would have withstood challenge under Daubert and Rule 702, based on their lack of qualifications to opine on the subjects at issue and the speculative and unsupported nature of their opinions. In eases filed under the Vaccine Act, where the rules of evidence do not apply, Daubert does not generally serve as a basis to exclude testimony, but rather, a framework to weigh and evaluate testimony.
Snyder, 2009 WL 332044, at *138 (referring to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)). Although she speculated how other courts might apply Federal Rule of Evidence 702 to the evidence in this case, the special master unequivocally stated that the rule did not apply in this proceeding. That does not mean, however, that all expert testimony, regardless of its reliability, must be admitted in Vaccine Program cases. Indeed, Vaccine Rule 8(b) requires that the special master, â[i]n receiving evidence, ... must consider all relevant and reliable evidence governed by principles of fundamental fairness to both parties.â Thus, the Federal Circuit has sanctioned the use of the Daubert factors âas a tool or framework for conducting the inquiry into the reliability of evidence.â Terran ex rel. Terran v. Secây of HHS, 195 F.3d 1302, 1316 (Fed.Cir.2000);
In addition, the special masterâs finding of waiver was well-supported. As noted above, for various, legitimate reasons, respondent was unable to file the expert reports obtained from the U.K. MMR litigation until just before the Cedillo hearing. Petitioners agreed that additional proceedings could be conducted with respect to the material obtained from the U.K. MMR litigation at a later time and indicated that they intended to request additional materials from that litigation not obtained by respondent. The three special masters and respondent agreed to join petitionersâ application. Indeed, the special masters even signed a letter in support of petitionersâ application. Yet, petitioners never applied to the court in the United Kingdom for the data underlying Dr. Rimaâs expert report and testimony. Accordingly, the special master held:
With regard to their inability to examine any evidence underlying ... Dr. Rimaâs critiques of Unigenetics laboratoryâs results, petitioners also waived any objection by their failure to request disclosure of such materials from the U.K. court. As the testimony ... makes abundantly clear, voluminous materials were filed with the U.K. court regarding the laboratoryâs operations. Although Unigenetics is no longer in business, the U.K. court is. Given the amount of impassioned argument devoted to the petitionersâ need for such materials, petitionersâ failure to lodge a request for their disclosure in the months following all three Theory 1 hearings is inexplicable. It is also waiver.
Id. at *27. Petitioners now argue that she âimproperly shift[ed] the burden of discovery from the Special Masters to the petitioners.â Mot. 53.
As previously noted, the Vaccine Act provides that â[tjhere may be no discovery in a proceeding on a petition other than the discovery required by the special master.â 42 U.S.C. § 300aa-12(d)(3)(B); accord Vaccine Rule 7(a) (âThere is no discovery as a matter of right.â). In the House Report supporting the original Vaccine Act, Congress explained that because it expected a special master âto be vigorous and diligent in investigating fac
Petitioners complain that although they ârepeatedly asked the Special Masters to intervene to obtain the requested UK materialsf, i]n every instance the Special Masters declined.â
I noted that the Hague Convention governed subpoenas in foreign jurisdictions,58 *739 and that a subpoena for a document under seal was not the normal method of obtaining [the information sought]. Once again, respondentâs counsel offered to assist petitioners in obtaining any documents they sought, and stated that U.K. law allowed third parties, including private litigants, to obtain matters filed under seal.
Snyder, 2009 WL 332044, at *26 (footnote added). Although the special master had complete control over the discovery process in this case, such control does not extend to compelling a court in a foreign jurisdiction to unseal documents. Petitioners acknowledged this fact at oral argument before the undersigned. See Oral Argument Tr. 8 (â[T]he special masters consistently said that they did not have the power on their own to obtain that information from the United Kingdom jurisdiction.â), 12 (agreeing that the special masters lacked âthe authority or the ability to move Justice Keith to produce those materialsâ). Accordingly, the special master did not improperly shift the burden to petitioners to obtain the documents from the U.K. MMR litigation â there was no burden to shift because the special master could not have obtained the evidence sought by petitioners in the first instance. And, because she gave petitioners every opportunity to obtain those documents, and expressly supported them application, petitionersâ failure to apply to the court in the United Kingdom for the documents is sufficient for a finding of waiver. For all of the foregoing reasons, the court finds that the special master did not abuse her discretion in considering Dr. Rimaâs testimony absent the underlying data. Petitionersâ fifth numbered objection is rejected.
F. Petitionersâ Sixth Numbered Objection: Refusing to Consider Significant Posthearing Evidence
In their sixth numbered objection, petitioners contend that the special master erred in denying their motion for reconsideration, and, accordingly, refusing to consider the ânewâ evidence submitted with their motion, which was ânot available at the time of the hearing in June of 2007_â Mot. 54-55. Specifically, they claim:
This new evidence significantly affects many critical aspects of the special masterâs decision. Given the familiarity of the special master with the science in Coltenâs case, and given the limited nature of this new evidence, the special master should have been able to quickly decide if this new evidence is worthy of consideration. In light of the significance of the evidence, and in light of the impact of this decision upon thousands of autistic children in the Program, her failure to do so was an abuse of discretion.
Id. at 55.
The special masterâs March 16, 2009 ruling on petitionersâ motion for reconsideration contains the salient facts. Petitioners filed their motion on Friday, March 13, 2009, at 6:02 p.m. Almost all of the ânewâ evidence submitted with the motion was published before she rendered her decision.
Special masters have âwide discretion in conducting the proceedings in a case.â Burns, 3 F.3d at 417; accord 42 U.S.C. § 300aa-12(d)(3)(B); Vaccine Rule 8(a); Doe, 76 Fed.Cl. at 338-39; Sword, 44 Fed.Cl. at 190. This discretion âapplies to petitions for reconsideration of rulings, and proffers designed to supplement the factual record after the record is closed.â Sword, 44 Fed.Cl. at 190. The court fords no abuse of discretion here.
[Tjhis Court will not aid a party who seeks to present additional evidence after his initial effort proves unpersuasive....
.... What trial attorney worth his or her salt would not try a ease a bit differently once counsel knew what the fact-finder found important within the body of evidence? But fairness does not require that we accede to this all-[too]-human desire. In fact, under the circumstances it would impose an undue burden to delay the resolution of this case any further.
Id. at 190-91. The court therefore rejects petitionersâ sixth numbered objection.
G. Petitionersâ Seventh Numbered Objection; Decision Not in Accordance With the Law
In their seventh, and final, numbered objection, petitioners argue that â[t]he special master improperly applied Daubert to the expertsâ conclusions and improperly ignored the teachings of recent Federal Circuit decisions.â Mot. 56. Prior to addressing petitionersâ argument, a brief summary of the relevant Federal Circuit precedent is instructive.
1. Proving Causation Under the Vaccine Act
Pursuant to 42 U.S.C. § 300aa-13(a)(l), the court shall award compensation if a petitioner proves, by a preponderance of evidence, all of the elements set forth in 42 U.S.C. § 300aa-ll(e)(l), and if there is not a preponderance of evidence that the illness is not due to factors unrelated to the administration of the vaccine.
To establish a prima facie case when proceeding on a causation-in-fact theory, a petitioner must âprove, by a preponderance of the evidence, that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury.â Shyface v. Secây of HHS, 165 F.3d 1344, 1352 (Fed.Cir.1999). â[T]o show that the vaccine was a substantial factor in bringing
In Althen, the Federal Circuit articulated a three-part test, based on this prior precedent, explaining what a petitioner must show to prove causation-in-fact under the Vaccine Act:
[Petitioner's burden is to show by preponderant evidence that the vaccination brought about [the] 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.
418 F.3d at 1278. The first prong seeks to demonstrate whether ââthe vaccine(s) at issue cause the type of injury alleged.â â Paf-ford, 451 F.3d at 1355-56 (quoting the decision of the special master as recited by the trial court).
The second prong requires a petitioner to show âthat the vaecine was the âbut forâ cause of the harm,â id. at 1356, or, in other words, â âthat the vaccine actually caused the alleged symptoms in [the] particular case,â â id. (quoting the decision of the special master as recited by the trial court); see also Capizzano v. Secây of HHS, 440 F.3d 1317, 1326 (â âA logical sequence of cause and effectâ means what it sounds like â the claimantâs theory of cause and effect must be logical.â). A petitioner is not required to provide âconclusive evidence in the medical literature linkingâ the vaccine to the injury alleged. Andreu, 569 F.3d at 1378; see also id. at 1379 (â â[I]n a field bereft of complete and direct proof of how vaccines affect the human body,â a paucity of medical literature supporting a particular theory of causation cannot serve as a bar to recovery.â (quoting Althen, 418 F.3d at 1280)); Capizzano, 440 F.3d at 1325 (â[R]e-quiring either epidemiologic studies, rechal-lenge, the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical communities to establish a logical sequence of cause and effect is contrary to what we said in Althen -â). Moreover, the âmedical records and medical opinion testimonyâ of treating physicians can be âprobative,â because âtreating physicians are likely to be in the best position to determine whether a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.â â Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1278); accord Andreu, 569 F.3d at 1376.
The third prong, although probative, is insufficient, standing alone, to prove causation. Althen, 418 F.3d at 1278. Moreover, the prong ârequires preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorderâs etiology, it is medically acceptable to infer causation-in-fact.â de Bazan, 539 F.3d at 1352. âIf a claimant satisfies the first and third prongs of the Althen standard, the second prong can be met through medical opinion testimony.â Andreu, 569 F.3d at 1375 (citing Capizzano, 440 F.3d at 1326). All three prongs âmust cumulatively show that the vaccination was a âbut-forâ cause of the harm, rather than just an insubstantial contributor in, or one among several possible causes of, the ham.â Paf-ford, 451 F.3d at 1355.
Once a petitioner has established a prima facie ease, the burden shifts to respon
2. Improper Use of Daubert
Petitioners first make the blanket accusation that the special master âimproperly applied Daubert to the expertsâ conclusions,â rather than to the methods employed by the experts.
Daubert requires a trial judge to perform âa preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.â 509 U.S. at 592-93, 113 S.Ct. 2786. Moreover, â[t]he inquiry ... is, ... a flexible one. Its overarching subject is the scientific validityâand thus the evidentiary relevance and reliabilityâof the principles that underlie a proposed submission. The focus, of course, must be solely on principles and methodology, not on the conclusions that they generate.â Id. at 594-95, 113 S.Ct. 2786 (footnote omitted). The Supreme Court later acknowledged, however, that âconclusions and methodology are not entirely distinct from one another.â Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). It further explained:
*743 Trained experts commonly extrapolate from existing data. But nothing in ... Daubert ... requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.
Id. Viewed in its totality, âthe law grants a district court the same broad latitude when it decides how to determine reliability as it enjoys in respect to its ultimate reliability determination.â Kumho Tire Co. v. Carmichael, 526 U.S. 137, 142, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999).
The special master described her general approach in applying Daubert to the evidence in the instant ease:
The special master determines the reliability and plausibility of the expert medical opinions offered and the credibility of the experts offering them. Not all evidence carries equal weight with a trier of fact. A medical opinion on causation may be based on factually incorrect medical histories or it may be offered by someone without the necessary training, education, or experience to offer a reliable opinion. An expertâs opinion may be unpersuasive for a variety of reasons. Courts, whether they deal with vaccine injuries, medical malpractice claims, toxic torts, or accident reconstruction, must base their decisions on reliable evidence. Daubert, 509 U.S. at 594-96, 113 S.Ct. 2786. Daubert provides a useful framework for evaluating scientific evidence in Vaccine Act eases. Terran v. Secây, HHS, 41 Fed.Cl. 330, 336 (1998), aff'd, 195 F.3d 1302, 1316 (Fed.Cir.1999).... See also Ryman v. Secây, HHS, 65 Fed.Cl. 35, 40 (2005) (special master performs gatekeeping function when he âdetermines whether a particular petitionerâs expert medical testimony supporting biologic probability may be admitted or credited or otherwise relied uponâ).
Snyder, 2009 WL 332044, at *30. She further explained that â[ujnder the Vaccine Act, a special master may determine the reliability of a medical theory by considering the â framework established by Daubert â and that âDaubert requires that an opinion be supported by something more than subjective belief; it must be grounded âin the methods and procedures of science.ââ Id. at *194. She continued:
Daubert provided a non-exhaustive list of factors for a court to consider in evaluating a proffer of expert testimony: (1) whether a theory has or can be tested; (2) whether the theory has been subjected to peer review and publication (a relevant, but not dispositive consideration); (3) the known or potential error rate of a technique; and (4) whether the theory enjoys general acceptance in the relevant scientific community. Kumho Tire added that a trial judge must ensure âthat an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.â
The Ninth Circuit applied an additional factor to the analysis of an expertâs opinion.... The circuit court considered whether the matters the expert proposed to testify about flowed from research conducted independently of involvement in the litigation in question, because this factor provides objective proof that the research was conducted for scientific purposes.
Id. at *138-39; accord id. at *194. Moreover, as noted by the special master, â[i]n his opening statement in Snyder, petitionersâ counsel appeared to agree that Daubertâs non-exhaustive list of factors to consider in determining the admissibility of an expertâs opinion were appropriate factors to consider in weighing and evaluating evidence in this case.â Id. at *9 n. 33; accord Oral Argument Tr. 54, 60-61.
The special master initially applied Dau-bert and its progeny in her evaluation of the partiesâ expert witnesses. She explained:
My evaluation of the quality of the testimony and the qualifications of the witnesses offering that testimony is based, in part, on the factors the Supreme Court set forth in Daubert ... and Kumho Tire Company. ... It is also based on my personal observations of each witness who testified. I emphasize that my decision is not based*744 solely on the expertsâ relative qualifications; although that is an important factor, it is not, standing alone, determinative. A qualified expert with lesser qualifications may offer an opinion that, for a variety of reasons, is more persuasive than that of a more qualified expert testifying on behalf of an opposing party.
Snyder, 2009 WL 332044, at *9 (footnote omitted). First, with respect to Dr. Kennedy, she noted that his one publication on the measles vaccine was authored for the sole purpose of litigation. Id. (citing Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1317 (9th Cir.1994)). She then noted concerns with Dr. Kinsbourneâs intellectual rigor and frequency of testifying in Vaccine Program eases. Id. at *11 (citing Kumho Tire Co., 526 U.S. at 152, 119 S.Ct. 1167), 12 (citing Daubert, 43 F.3d at 1317). Finally, she noted that âtwo courts ha[d] refused, based on Daubert, to permit [Dr. Bradstreet] to testify as an expert witness in cases alleging that vaccines cause or contribute to [autism spectrum disorder].â Id. at *21 (citing Redfoot v. B.F. Ascher & Co., No. C 05-2045 PJH, 2007 WL 1593239, at *12 (N.D.Cal. June 1, 2007); Easter v. Aventis Pasteur, Inc., 358 F.Supp.2d 574 (E.D.Tex.2005)).
Next, the special master applied Daubert in evaluating petitionersâ proffered medical theory. She first concluded that petitionersâ theory, as described by Dr. Kinsbourne, was not generally accepted or supported by peer-reviewed medical literature.
The court finds no error in the special masterâs application of the framework suggested by Daubert. Federal Circuit precedent explicitly permits a special master to evaluate scientific evidence using the Dau-bert factors. See Terran, 195 F.3d at 1316; cf. Andreu, 569 F.3d at 1379 (citing Daubert with approval). Here, the special master considered all of the relevant evidence submitted by both parties, using the Daubert factors only to determine the reliability of that evidence and, hence, the weight it should be assigned. Indeed, by allowing all relevant evidence to be admitted into the record, regardless of its reliability, the special master was actually being quite generous to petitioners. As the special master noted throughout her decision, petitionersâ expert witnesses compared unfavorably to respondentâs expert witnesses in many respects: their credentials,
Accordingly, to the extent that petitioners are complaining that the special masterâs use of the Daubert factors resulted in a failure to consider their evidence, they are mistaken. Rather, the special master evaluated all of the evidence presented by both parties and determined that the science behind petitionersâ theory was lacking. Contrary to petitionersâ contention that the investigation into the link between the MMR vaccine, along with all thimerosal-containing vaccines, and autism spectrum disorders âis âbereftâ of science,â Mot. 11, the record demonstrates that there is an abundance of science in this area â -just not science that supports petitionersâ position. The special masterâs application of Daubert was in accordance with the law.
3. Causation
Petitioners further contend that they have established a prima facie case pursuant to the three-part test set forth in Althen and that respondent failed to establish an alternative cause. Id. at 59. Them argument, in its entirety, is as follows:
Has Colten satisfied the Althen factors? Clearly, he has a medical theory. His evidence is strong that the MMR vaccine is capable of causing a wide variety of brain injuries, including autism. Next, there was a logical sequence of cause and effect between his MMR vaccine and the injury. He was healthy, received an MMR vaccine, and as his treating physicians attest, he was never again the same. There is no question that his symptoms first occurred within an appropriate time after the MMR vaccine. This fact is supported by Coltenâs medical records and by the respondentâs expert Dr. Griffin. It is even supported by the Vaccine Injury Table that lists â5-15â days after the MMR as the appropriate time frame for the onset of symptoms of brain damage. See 42 U.S.C. Section 300aa-14.
Id. Such a perfunctory argument requires little attention.
As noted above, the special master found under the first prong of the Althen test that petitionersâ medical theory was not reliable. See Snyder, 2009 WL 332044, at **194-95. Under the second prong, she found that there was no âlogical connection between Coltenâs vaccinations and his medical conditionâ because of the unreliability of the test results indicating the presence of measles virus in Coltenâs CSF and the absolute necessity of the presence of measles virus for petitionersâ theory of causation. Id. at **195-97. She also found that the medical records and medical opinion testimony of Dr. Bradstreet, one of Coltenâs treating physicians, were unsupportive of causative link.
The court finds no error in the special masterâs findings. The special masterâs conclusion that petitioners did not present a biologically plausible medical theory is clearly supported by the record. She found that the various aspects of petitionersâ theory were not scientifically sound and that the lynchpin of their theory was wholly unreliable. See id. at **87-93 (petitionersâ theory), **116-35 (Unigeneticsâ reliability). Next, the special master's conclusion that petitioners had not established a logical sequence of cause and effect is also supported by the record. As noted above, petitionersâ theory of causation depended upon, among other things, Coltenâs immune system being damaged by the MMR vaccine (but not thimero-sal-containing vaccines), the persistence of the measles virus in Coltenâs body, Coltenâs development of inflammatory bowel disease, and the presence of the measles virus in Coltenâs brain. The special master found that petitioners had demonstrated none of these necessary elements by a preponderance of the evidence. See id. at **185-86 (dysregulated immune system), 186-87 (inflammatory bowel disease), 188-92 (persistence and presence of the measles virus). Further, the special masterâs conclusion that the onset of Coltenâs symptoms did not occur within a biologically acceptable time period following the MMR vaccination is supported by the record. She found that based on the medical records, the onset of Coltenâs symptoms did not occur at the time suggested by petitioners. Id. at **197-98. Given that petitioners had not established any of the prongs of the test set forth in Althen, the special master correctly concluded that the burden of proving an alternative cause never shifted to respondent. See Bradley, 991 F.2d at 1575.
Petitionersâ complaints with the special masterâs decision amount to nothing more than dissatisfaction with the weight she assigned to the evidence. Yet, as the court has repeated throughout this opinion, the special master is accorded great deference in determining how much weight to assign to the evidence in the record. She was the one who read all of the medical records, expert reports, and medical literature, and heard all of the testimony, placing her in the best position to ascertain whether petitioners established a prima facie case of causation. The special master exercised her discretion appropriately here and her decision was not contrary to law. The court thus rejects petitionersâ seventh numbered objection.
H. Petitionersâ Allegation of Bias
The court has addressed all of petitionersâ numbered objections, finding them to be without merit. However, petitioners lodge other complaints about the special masterâs conduct that despite their lack of merit, cannot be ignored. Specifically, petitioners advance the remarkable complaint that âthe special master abandoned her obligation to impartially weigh the evidence.... [Ijnstead, the special master inappropriately assumed the respondentâs role as protector of the integrity of vaccines.â Mot. 6. Petitioners later elaborate:
During the past decade, the publicity afforded the issue of whether vaccines can cause autism has been intense.... [D]ue to this publicity, ... the special master feared that a finding in [petitionersâ] favor would drive down immunization rates. For this reason, to protect the integrity of vaccines, Coltenâs case, a so-called âtestâ case, was treated far differently than other vaccine program petitioners. First, after thousands of other autistic children had*747 filed claims, and after years of intense public controversy over the vaccine/autism connection, the respondent was permitted to present the opinions of seventeen experts to defeat Coltenâs claim. In so doing, the special master treated Colten far differently than other petitioners.68 In addition, disregarding the Federal Circuitâs recent decisions in Althen and Capizzano, the special master instead invoked Dauberb and found virtually all of Coltenâs evidence unreliable. For her to do so ... was fundamentally unfair. [Petitioners were] entitled to equal treatment.
Id. at 11; accord id. at 17 (complaining that the special master did not afford petitioners âthe âfundamental fairnessâ required by the Vaccine Rulesâ due to the âextraordinary publicityâ given the three Theory 1 test cases and, as a result, Colten âwas sacrificed to protect the integrity of vaccinesâ
[T]he special master ignored [petitionersâ] considerable, albeit circumstantial, evidence that a persisting vaccine-strain measles virus caused [his inflammatory bowel disease] and autism_ [S]he did so because of the intense national publicity this ease has received_ [S]he did so to assure the American public that vaccines are safe. She did so because she views her role as a protector of the integrity of our nationâs vaccines. This, however, is the role of the respondent, not a special master.
.... [T]he special master, to protect vaccine integrity in a very public case, chose to impose upon [petitioners] an unattainable standard of proof. To protect the vaccineâs integrity she rejected all of petitionerâs credible evidence and simply accepted the conclusions of the respondentâs seventeen experts, denying [petitioners] the fundamental fairness required by the Vaccine Rules, ignored Congresses] intent in establishing the Vaccine Program, and rejected the Federal Circuitâs interpretation of that intent.
Id. at 19-21. Finally, at oral argument, petitioners attempted to justify their charge of bias by arguing that it was fundamentally unfair for the special master to admit the purportedly unreliable evidence from Dr. Bustin and Dr. Rima and, thereafter, âallow[] the credibility of those witnesses to substitute for the reliability of those witnesses on key issues_â Oral Argument Tr. 30-31.
Petitionersâ charge â that the special master feared a public backlash against vaccines if she ruled in their favor â is preposterous. There is not a shred of evidence to support petitionersâ claim;
Indeed, it is abundantly clear from her decision that the special master took great care in considering all of the evidence in the record â whether presented by petitioners or respondent â and applying the appropriate legal standards in evaluating that evidence. As the Court of Federal Claims stated in Ultimo:
This sort of personal attack on the [special master] is highly inappropriate, contentious, and unpersuasive.... Petitioner ... accuses the [special master] of subverting the intent of Congress in establishing the Program. The court will not condone such frivolous, unsubstantiated accusations. Accordingly, the court finds that petitionerâs ... objection is completely without merit. Petitioner is forewarned that any repetition of such groundless accusations may cause the court to entertain sanctions against petitioner and petitionerâs counsel pursuant to RCFC 11.
28 Fed.Cl. at 153.
III. CONCLUSION
As the special masterâs decision makes clear, Colten, and by extension, his family, have dealt with significant adversity for many years, and, like the special master, the court is very sympathetic to their circumstances. However, the court cannot be ruled by emotion and base its determination solely upon the adversity endured by petitionersâ family. Moreover, it is not the task of this court to determine whether vaccines cause autism or other neurodevelopmental disorders. Rather, the court must decide whether the special master, considering the record as a whole, rendered a decision that was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. She did not. Her decision was entirely rational and fully supported by the record. Thus, the court DENIES petitionersâ motion for review. Pursuant to Vaccine Rule 30(a), the clerk is directed to enter judgment in accordance with this decision.
IT IS SO ORDERED.
. The other two cases were Cedillo v. Secretary of HHS, No. 98-916V, and Hazlehurst v. Secretary of HHS, No. 03-654V.
. In their motion for review, petitioners lodge no objections against the special masterâs recitation of Colten Snyder's medical history, diagnoses, and treatments. See Snyder, 2009 WL 332044, at **147-81 (containing sections VIII.B-C of the special masterâs decision). Thus, the court cites to the special masterâs decision rather than the underlying record.
. The vaccinations included those against hepatitis B; hemophilus influenzae type b ("Hibâ); diphtheria, pertussis, and tetanus; and polio. Snyder, 2009 WL 332044, at **149-50 & nn. 421-22. "The parties stipulated that thimerosal was present in 'preservative amounts' in the three hepatitis B vaccines and the three [Hib] vaccines Colten received_" Id. at *147 n. 414.
.Colten also received an additional vaccination against diphtheria, pertussis, and tetanus. Snyder, 2009 WL 332044, at *147 n. 414, 157. The parties "stipulated that thimerosal was not present, or present only in trace amounts,â in that vaccine. Id. at *147 n. 414.
. Although afforded the opportunity to do so by the special master, see Order 2, June 25, 2007, petitioners did not amend their petition to reflect the clarified injury.
. The other special master assigned to the Omnibus Autism Proceeding with Special Masters Vo-well and Hastings was Special Master Patricia Campbell-Smith.
. The Autism Master File is accessible on the website of the United States Court of Federal Claims ("Court of Federal Claimsâ) at the following address: http://www.uscfc.uscourts.gov/node/ 2718.
. This hearing was officially conducted in the Cedillo case. Snyder, 2009 WL 332044, at *6; Autism Master File: Autism Update 3, July 12, 2007.
. The special master indicates that she also heard expert testimony during the hearing in the Hazlehurst case. Snyder, 2009 WL 332044, at *8.
. According to the special master, she considered "all of the evidence, less the medical records of the other children, introduced before, during, and after the hearings in Cedillo and Hazlehurst, as well as all of the evidence filed in this case.â Snyder, 2009 WL 332044, at *T. Specifically, the evidentiary record included:
nearly four weeks of testimony, including that offered in the Cedillo and Hazlehurst cases; over 900 medical and scientific journal articles; 50 expert reports (including several reports of witnesses who did not testify); supplemental expert reports filed by both parties post-hearing, the testimony of fact witnesses on behalf of Colten, and Cohenâs medical records.
Id. at *8 (footnote omitted). When citing to the record before the special master, the court prefaces the exhibit or transcript citation with the name of the case with which the evidence is associated, similar to the conventions adopted by the special master. See id. at **7-8. Also, for simplicity, citations to the corrected hearing transcripts include only the case name and page numbers.
.The Court of Federal Claims amended the Vaccine Rules effective July 13, 2009, to, among other things, bring the Vaccine Rules into conformity with the general restyling of the RCFC, see Vaccine Rules, 2009 Rules Committee Note, which the Court of Federal Claims had recently amended to conform with the general restyling of the Federal Rules of Civil Procedure, see generally RCFC, Rules Committee Notes 3 (noting that the "court has adopted a policy of regularly amending its rules to reflect parallel changes in the Federal Rules of Civil Procedureâ). No substantive changes were made to any of the rules at issue here. Accordingly, except in section II.A
. Although Congress did not initially specify in the Vaccine Act that this section applied to the special masters, see § 311(a), 100 Stat. at 3763 (limiting the application of the section to âthe courtâ), it soon amended the Vaccine Act to reflect the fact that this section also applied to special masters, see Omnibus Budget Reconciliation Act of 1989, Pub.L. No. 101-239, § 66010(1), 103 Stat. 2106, 2290 (codified at 42 U.S.C. § 300aa-13(b)(l) (2006)).
. This was the second set of rules promulgated by the Claims Court for Vaccine Program cases. The first set of rules, dated January 25, 1989, was criticized by Congress as too formal. See H.R.Rep. No. 101-386, at 84 ("The Claims Court has issued rules for vaccine proceedings that force proceedings to be formal and that virtually foreclose any opportunity for petitioners or respondents to proceed without litigators at their sides.â); accord id. at 86.
.For example, Congress has amended the Vaccine Act to introduce a provision for suspending proceedings, to change the compensation provision, and to expand the scope of compensable injuries. See, e.g., Children's Health Act of 2000, Pub.L. No. 106-310, § 1701, 114 Stat. 1101, 1151 (codified at 42 U.S.C. § 300aa-l 1(c)(1)(D) (2006)); Health Information, Health Promotion, and Vaccine Injury Compensation Amendments of 1991, Pub.L. No. 102-168, tit. II, 105 Stat. 1102, 1102-04 (codified as amended at 42 U.S.C. §§ 300aa-l, -11 to -12, -15 to -16, -19 (2006)); Vaccine and Immunization Amendments of 1990, Pub.L. No. 101-502, § 5, 104 Stat. 1285, 1286-89 (codified as amended at 42 U.S.C. §§ 300aa-l, -11 to -13, -15 to -16, -21 (2006)).
. Sections 300aa-12(d)(3)(A) and 300aa-12(e)(2) were amended in 1992 to reflect the renaming of the Claims Court to the Court of Federal Claims. See Court of Federal Claims Technical and Procedural Improvements Act of 1992, Pub.L. No. 102-572, § 902(b), 106 Stat. 4506, 4516.
. The Vaccine Rules were left untouched for over a decade. On May 1, 2002, the Court of Federal Claims adopted a revised set of Vaccine
. Prior decisions of the Court of Federal Claims, "while persuasive, do not set binding precedent for separate and distinct casesâ in the Court of Federal Claims. W. Coast Gen. Corp. v. Dalton, 39 F.3d 312, 315 (Fed.Cir.1994).
. Although the respondent in all Vaccine Act cases is the Secretary of the Department of Health and Human Services, 42 U.S.C. § 300aa-12(b)(1), the respondent in Sword is identified as the United States.
. The Federal Circuit has described the standard of review it applies in Vaccine Act cases in the following manner: "This court reviews the United States Court of Federal Claims' review of the Special Master's decision without deference.â Pafford ex rel. Pafford v. Secây of HHS, 451 F.3d 1352, 1355 (Fed.Cir.2006) (citing Hines, 940 F.2d at 1524).
. As outlined in Sharpnack, a decision is arbitrary and capricious if:
the special master has relied on factors which Congress has not intended to be considered, or has entirely failed to consider an important aspect of the problem, or has offered an explanation of the decision that runs counter to the evidence, or is so implausible it could not be ascribed to a difference in view or a product of expertise.
. The court notes that the âfundamental fairness" requirement cited by petitioners refers specifically to what evidence the special master is required to consider, and not the subsequent analysis of that evidence in rendering a decision. See Vaccine Rule 8(b)(1) ("In 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.â). Of course, the special masters, like all judicial officers, are required to treat all parties fairly. See, e.g., Caperton v. A.T. Massey Coal Co., - U.S. -, 129 S.Ct. 2252, 2266, 173 L.Ed.2d 1208 (2009) (acknowledging the âpartiesâ basic right to a fair trial in a fair tribunalâ); Day v. McDonough, 547 U.S. 198, 210, 126 S.Ct. 1675, 164 L.Ed.2d 376 (2006) ("[Bjefore acting on its own initiative, a court must accord the parties fair notice and an opportunity to present their positions.â).
. Only decisions of the United States Supreme Court ("Supreme Courtâ), the Federal Circuit, the Federal Circuit's predecessor court (the United States Court of Claims), and the Court of Federal Claims in the same case on remand are binding on the special masters. See Jones v. Secây of HHS, 78 Fed.Cl. 403 (2007) ("The Special Master correctly concluded that he is bound by the decision of the Federal Circuit.â); Hanlon ex rel. Hanlon v. Secây of HHS, 40 Fed.Cl. 625, 630 (1998) ("Special masters are neither bound by their own decisions nor by cases from the Court of Federal Claims, except, of course, in the same case on remand.â), aff'd, 191 F.3d 1344 (Fed.Cir.1999).
. The court notes that petitioners were not required to participate in the Omnibus Autism Proceeding in the first instance and that they retained the ability to withdraw their petition from the Omnibus Autism Proceeding â and proceed independently â at any time. Autism General Order # 1, 2002 WL 3166785, at *6-7. Consequently, their claim of prejudice' â advanced after the Theory 1 proceedings concluded and an adverse decision has been rendered â rings hollow.
. For this reason, the litany of cases that petitioners recite in their motion for review for the propositions that (1) special masters in other cases have, "based on circumstantial evidence alone," established that vaccines have caused various injuries and (2) special masters in other cases have found that â[t]he MMR vaccine ... was the legal cause of [various] off-Table neurological injuries," see Mot. 12-15 & nn. 14-38, is irrelevant.
.At oral argument, petitioners appeared to change their argument, contending:
I should clarify that the prejudice that was caused was primarily when there were errors ..., th[ose] error[s] got compounded because [they] occurred in front of a panel of three. It's a bell that one cannot unring in front of three different people.
And so it creates on any one individual petitioner the burden of having to then make sure ... that the evidence that was adduced in the other cases and the procedures and the decisions in the other cases were all without error too. It compounds the burden on petitioners] in the presentation of evidence and it has the risk ... of compounding and magnifying an error in one case and making it an error in the other [cases] because it all happened in front of the same group of people at the same time. Oral Argument Tr. 15-16, July 29, 2009. However, this argument suffers from the same flaws as the argument petitioners advanced in their motion for review. If Special Master Vowell concluded that an evidentiary or procedural error had occurred, she was free to make such a ruling independent of the other two special masters when rendering her decision.
. It bears noting that petitioners do not dispute the special master's recitation of the following procedural history in their motion for review; in fact, they fail to mention it at all.
. There is no evidence in the record that petitioners dispute respondent's representation that he did not ascertain the critical role played by Unigeneticsâ testing in petitionersâ theory of causation until he received petitionersâ expert reports.
. Petitioners do not object to the filing of this report in their motion for review.
. On this same date, respondent filed a motion to exclude all of the test results from Unigenetics, attaching to the motion affidavits from Dr. Bus-tin and Dr. Bertus Rima. Snyder, 2009 WL 332044, at *23. Accordingly, petitioners were notified that these two doctors âwould be involved in the litigation." Oral Argument Tr. 46.
.At oral argument, petitioners reiterated their concern that the "11th hour late introduction of voluminous, highly technical, extremely difficult material deprived [them] of an opportunity to conduct a meaningful cross-examination.â Oral Argument Tr. 6. The court notes that despite petitioners' emphasis on this issue, there is no right to cross-examination in Vaccine Program proceedings. 42 U.S.C. § 300aa-l 2(d)(2)(D).
. At the November 2007 hearing, one of petitionersâ expert witnesses, Dr. Ronald Kennedy, testified, in response to questioning by the special master, that he had not been asked by petitionersâ counsel to "support the release of his own report in the U.K. MMR litigation," despite having no objections to its release. Snyder, 2009 WL 332044, at *25. Given this testimony, the special master inquired about petitionersâ progress in obtaining the U.K. MMR litigation material. Id. One of petitionersâ attorneys asserted "that petitioners' experts wanted to use information from the U.K litigation, but could not obtain it.â Id. On further questioning from the special master, he elaborated that petitioners' counsel "had made inquiries, but were informed by outside counsel that they could not obtain the information.â Id.; accord Oral Argument Tr. 8-9 (indicating that petitioners retained a barrister in the United Kingdom to assist them). Yet, he contended, "petitioners' counsel was actively investigating what needed to be done to gain release of documents.â Snyder, 2009 WL 332044, at *25. As the special master explained in her decision, this âcharacterization ... of the efforts to obtain additional U.K. reports differs from the statement that appears in the noticeâ filed by petitionersâ counsel on July 31, 2008, id. at *25 n. 77, which provided: "In the period between the Cedillo and Snyder hearings, the petitioners sought, unsuccessfully, to obtain the claimant-side reports from the UK," Autism Master File: PSC Notice Re: UK Litigation Materials and the First Theory of General Causation 2, July 31, 2008. The special master remarked:
This statement implied that petitioners actually made some effort to obtain the U.K. litigation materials. It was apparent to me from Dr. Kennedyâs testimony that his support for release of his report had not been sought, and from the on-the-record response of counsel to my questions, that petitionersâ efforts to obtain these materials had not progressed to the stage of making any application, or, indeed, anything beyond talking about the process.
Snyder, 2009 WL 332044, at *25 n. 77. The special masterâs conclusion is buttressed by the statements made by petitionersâ counsel at oral argument. Counsel stated that in order to submit an application to the court in the United Kingdom, petitioners "needed to ... get affirmative waivers of any confidentiality from all of ... the expert witnesses!] who participated in that litigation ..., and we made those efforts. For different reasons, the experts whose reports we sought were not forthcoming with their permission.â Oral Argument Tr. 8; see also id. at 9 (indicating that the two individuals in possession of the information they desired â Dr. John OâLeary and Dr. Orla Sheils â were nonrespon-sive to petitionersâ requests).
. Petitioners' characterization of the statements as "concessionsâ is somewhat misleading, as it implies that the experts were admitting facts not supportive of respondentâs position. As will be shown, such an implication is incorrect.
. Petitionersâ contention at oral argument that they "outlined and explained in some detail" in their motion for review the evidence allegedly ignored by the special master, Oral Argument Tr. 16-17, is flatly untrue.
. Petitioners also advanced another theory of causation via the report and testimony of Dr. Jean Ronel-Corbier, a neurologist. See Snyder, 2009 WL 332044, at *12. Dr. Corbier proposed that Colten's MMR vaccination triggered an autoimmune disorder, which in turn caused Col-ten's autism-like symptoms. Id. at **93-94. The special master rejected Dr. Corbier's testimony, id. at *94, and petitioners have not challenged the special masterâs ruling on this point.
. "PCRâ is short for "polymerase chain reaction" and "is a method of exponentially replicating a strand of DNA.â Snyder, 2009 WL 332044, at *110.
. This statement is at slight variance with the actual statement contained in the article coauthored by Dr. Griffin and cited by petitioners: "Currently, the World Health Organization and the American Academy of Pediatrics recommend [measles virus] vaccination for all HIV-infected children, except those children defined as severely immunocompromised on the basis of age-specific CD4+ T lymphocyte limits.â Snyder Petârs Ex. 205, at 439.
. In making this argument, petitioners erroneously assert that Dr. Griffin, "[d]uring cross-examination, ... acknowledged that she had not reviewed the Uhlmann articleâ that supported their claim. Mot. 42. Petitioners did not provide a citation for this testimony, and the court could locate no testimony to this effect. Indeed, Dr. Griffinâs testimony strongly suggests that she had read the article, but did not have it in front of her at the hearing. See Cedillo Tr. 2834A-36, 2863, 2866. Moreover, the article is both discussed in, and attached to, Dr. Griffin's expert report. See Cedillo Respât Ex. V. Consequently, petitionersâ assertion lacks foundation.
. In addition to these statements, petitioners argue that there is a conflict between Dr. Ward's testimony concerning opportunistic infections and the testimony of Dr. Ward's colleague in another case. Mot. 32 & n. 51. The testimony of Dr. Ward's colleague was not before the special master, and, thus, is irrelevant here. Moreover, the testimony of that colleague coincides with what the special master expressly concluded here, that "as a general rule, if a wild-type virus can cause a problem, the vaccine virus can also cause the problem, albeit in a milder or more attenuated form.â Snyder, 2009 WL 332044, at *99; accord id. at *104. Thus, petitioners' argument lacks merit.
. Once again, the court notes that Congress has expressly determined that there is no right to cross-examination in Vaccine Program proceedings. 42 U.S.C. § 300aa-12(d)(2)(D).
. No formal motion was filed in the instant case. Snyder, 2009 WL 332044, at **27, 116.
. In her alternative reliability analysis that addressed the publicly available information concerning Unigeneties along with the information obtained from the U.K. MMR litigation, the special master addressed Dr. Hepnerâs independent research referenced by petitioners in their motion for review. See Snyder, 2009 WL 332044, at **135-36 (containing a section titled "6. The Walker-Hepner 'Poster Presentation.' "); Mot. 39 (noting that Dr. Hepner "has herself replicated the [Unigeneties] lab's findingsâ). Given the preliminary, unpublished nature of Dr. Hepnerâs data, among other issues, the special master did not credit it. See Snyder, 2009 WL 332044, at **135-36.
. Further, to the extent that petitioners are contending that Dr. Bustin's âdispute was only with [Unigeneties'] low copy numbers,â Mot. 35 (citing Cedillo Tr.2042); accord id. at 36 (citing Cedillo Tr.2045[A]), to the exclusion of any other criticism of Unigeneties, their contention is erroneous. It is apparent from his testimony that Dr. Bustin had concerns about Unigenetiesâ low copy numbers, high cycle numbers, and standard curve. See, e.g., Cedillo Tr.2040 (indicating that âthere is a problem with the low copy numbers and the higher cycle numbersâ), 2045A (indicating that Dr. Bustin's "concern really is with low copy numbers and high cycles, high number of runsâ), 2062A-65A (explaining his problems with Unigeneties' standard curve). It was petitioners' expert, Dr. Kennedy, who testified: "I think the issue was that no one had any problem with high copy numbers.â Snyder Tr. 337A; see also Snyder, 2009 WL 332044, at * 117 ("Doctor Kennedy testified that, at least with the high copy number results, he considered the Unigenetiesâ results to be reliable.â). As an aside, petitioners attributed the following assertion to Dr. Kennedy: "[T]he group of scientists who studied the discrepancies between the labs unanimously concluded that [Unigeneticsâ] findings with respect to high copy numbers were absolutely reliable.â Mot. 39 (citing Snyder Tr. 346[A]). The testimony cited by petitioners, however, does not appear to conform with their representation.
. Accordingly, it is of absolutely no import that "Cohen, of course, had no access to this allegedly 'sealed' evidence from the UK litigation.â Mot. 38 n. 57. Moreover, as described elsewhere in this opinion, the special master concluded that petitionersâ lack of access was a problem of their own making.
. In raising this concern, petitioners accuse the special master of making the "preposterous conclusionâ that Dr. Bustin's testimony reflected that contamination in the Unigeneties laboratory was " ârampartâ[sic]." Mot. 37-38 n. 56. Assuming that petitioners meant "rampant,â their claim is baseless. Nowhere does the special master describe contamination in the Unigenet-ics laboratory as rampant. Petitioners may instead be referring to the decision of Special Master Hastings in Cedillo, where, in the course of describing the evidence presented concerning Unigeneties, he stated: "But when Dr. Bustin closely examined the results of the Uhlmann study, he found that in approximately one-third of Unigeneties' testing procedures ('runs'), the lab obtained positive results for their negative controls. Dr. Bustin testified that this result meant that contamination was rampant in the Unigeneties lab.â Cedillo, 2009 WL 331968, at *36 (citing Cedillo Tr. 1995-96 (containing Dr. Bustinâs testimony that "the presence of contamination in one-third of your assays suggests they have a significant contamination problemâ)).
. In this vein, Dr. Ward testified that an eighty percent concordance rate "would be unacceptable in a research setting, and was wildly inappropriate for a diagnostic lab, such as Unigenetics.â Snyder. 2009 WL 332044, at *123.
. At oral argument, petitioners changed tack. Rather than arguing that the contents of Dr. Oldstone's letter supported their position, they averred that Dr. Oldstone must have been the source of the twenty percent rate of misidentifi-cation. See Oral Argument Tr. 20 ("Dr. Kennedy testified that it was just as likely that the reason for the inconsistent results between Dr. Old-stone's lab and [Unigenetics] was that the samples were misidentified as to whether they were positive or negative to begin with."). Petitioners further claimed that "the special master ... just adopted the conclusion of Dr. Oldstone and frankly ignored significant testimony, particularly from Dr. Kennedy, that the claimed errors of Dr. Oldstone actually were errors that occurred in Dr. Oldstoneâs lab....â Id. Petitioners are incorrect. The special master addressed, and then, as was in her discretion, discounted Dr. Kennedyâs testimony. See Snyder, 2009 WL 332044, at *124 ("Although it is possible that contamination of the samples submitted occurred in Dr. Oldstone's laboratory, a position advanced by Dr. Kennedy, Dr. Ward discounted that possibility_Doctor Kennedy also suggested the misidentified samples were probably at the low end of the detection threshold, but his explanation did not account for false positive results nor how the same samples could test positive initially, but negative when submitted a second time, or vice versa.â (citations omitted)).
.Dr. Ward's testimony about his conversation with Dr. Oldstone that led to Dr. Oldstone's preparation of the letter similarly lacks support for this statement. See Snyder Tr. 952A-62A (direct testimony), 983A-91 (cross-examination). However, Dr. Kennedy's testimony, although unclear, might conceivably provide support for the statement. See id. at 337A-339A (suggesting that Dr. Oldstone had obtained high copy numbers from the technique he used, but expressing uncertainty regarding whether Dr. Oldstone used the same PCR technique as Unigenetics).
. Petitioners cite "Pet. Ex. 150â as the source of their "direct evidence,â Mot. 41, but no such exhibit exists in the record. The court presumes that petitioners meant to cite Cedillo Petitioners' Exhibit 130. See id. at 36 n. 53. This exhibit contains a brief synopsis of a paper titled "Development of an 'allelic discrimination' type assay to differentiate between the strain origins of measles virus detected in intestinal tissue of children with ileocolonic lymphonodular hyperplasia and concomitant developmental disorder.â â Cedillo Petârs Ex. 130. The underlying paper, if it exists, was not submitted into evidence.
. Petitioners also claim that the special master disregarded "the vast body of evidence regarding the effects of mercury on the immune system, and then declare[d] that petitioner had failed to prove that mercury exposure can lead to a dysfunctional immune system.â Mot. 49. This claim is similarly flawed. The special master devoted an entire section of her decision to the effects of mercury on the immune system. See Snyder, 2009 WL 332044, at *72-76 (containing a section titled "a. Immune Systems Effectsâ).
. Indeed, because of Dr. Kinsbourneâs position that "causation in Colten's case did not depend on any form of immune dysregulation predating Coltenâs [MMR] vaccination,â Snyder, 2009 WL 332044, at *183, the special master properly limited her analysis to any immune dysfunction caused by the MMR vaccine, see, e.g., id. at **185-86 (discussing Colten's alleged immune system dysfunction and concluding that "[t]he evidence that Colten's immune system was 'dy-sregulatedâ after his MMR vaccination is unconvincingâ).
. As was made clear in the courtâs analysis, the representations made by petitioners in their third and fourth numbered objections were almost wholly without a factual basis. Indeed, in several instances, petitioners were clearly attempting to mislead the court. See Mot. 31 (misrepresenting the contents of one of Dr. Griffin's articles), 34 (contending that Dr. Fujinami provided "significant evidenceâ but describing the evidence in one, general sentence and failing to actually explain the significance), 35 (misrepresenting Dr. Bustin's testimony and the contents of Dr. Old-stone's letter), 42 (misrepresenting whether Dr. Griffin had reviewed the Uhlmann article).
.Petitioners thrice reveal their true discontent in their motion for review â in the motion's introductory material, with respect to testimony that the copy numbers were too high, and regarding evidence of the use of allelic discrimination. See Mot. 5 ("[T]he Special Master[] erred by failing to give weight to the substantial concessions by respondentâs expert witnesses.â), 40 ("The special master, however, either ignored or discounted this important evidence.â (emphasis added)), 41 (âIn this case the special master ignored and discounted petitionerfs'] direct evidence ...." (emphasis added)).
. Petitioners imply that it is problematic that only "one Federal Circuit decision [stated] that special masters can use the Daubert factors to evaluate the reliability of scientific evidence in the [Vaccine] Program." Mot. 19 n. 43 (citing Terran, 195 F.3d at 1316). However, that "oneâ
. As respondent noted at oral argument, the arguments advanced by petitioners in support of excluding Dr. Rima's testimony would also support the exclusion of all of the test results from Unigenetics because petitioners did not submit the data underlying the test results as part of their prima facie case. See Oral Argument Tr. 50.
. The special master described these requests. She explained that "[d]uring the June 8, 2007 status conference, petitioners ... noted that they had sought release of U.K. litigation material through third party subpoenas to Merck three years earlier," but, "[apparently ignoring the fact that the U.K. court controlled release of the U.K. litigation materials, petitioners renewed a request for the court to subpoena Merck and other manufacturers to obtain the reports of all 65 experts in the U.K. litigation.â Snyder, 2009 WL 332044, at *24 (footnote omitted). She further explained:
Given the U.K. court's protective order on witnesses, it does not appear that Merck could have released those materials without the consent of the U.K. court, even if ordered to do so by Special Master Hastings. [Petitioners'] counsel conceded as much when he noted that their experts who were also experts in the U.K. litigation were subject to protective orders and, therefore, could not discuss their knowledge of the U.K. proceedings.
Id. at *24 n. 74 (citation omitted). Then, at the Snyder hearing, petitioners' counsel "expressed his concern and willingness to do what was necessary to obtain the U.K. expert reportsâ and "requested that [the special master] subpoena the reports from the U.K. court.â Id. at *26.
. Petitionersâ attempts to obtain the U.K. MMR litigation materials prior to 2007 have little relevance to the issue at hand: whether petitioners' failure to file an application with the court in the United Kingdom for the materials underlying Dr. Rimaâs expert report and testimony constituted waiver. It is clear from petitioners' description that none of their pre-2007 efforts included an attempt to obtain the materials directly from the United Kingdom court.
.As described by the Supreme Court:
The United States, the Republic of France, and 15 other Nations have acceded to the Hague Convention on the Taking of Evidence Abroad in Civil or Commercial Matters.... This Convention â sometimes referred to as the "Hague Conventionâ or the "Evidence Conventionââ prescribes certain procedures by which a judicial authority in one contracting state may request evidence located in another contracting state.
SociĂ©tĂ© Nationale Industrielle AĂ©rospatiale v. U.S. Dist. Court for the S. Dist. of Iowa, 482 U.S. 522, 524, 107 S.Ct. 2542, 96 L.Ed.2d 461 (1987) (citation omitted). The United Kingdom is one of the signatories. Id. at 524 n. 1, 107 S.Ct. 2542. Article 10 of the Hague Convention provides that "[i]n executing a Letter of Request the requested authority shall apply the appropriate measures of compulsion in the instances and to the same extent as are provided by its internal law for the execution of orders issued by the authorities of its own country or of requests made by parties in internal proceedings.â Convention on the Taking of Evidence Abroad in Civil or Commercial Matters, opened for signature Mar. 18, 1970, art. 10, 23 U.S.T. 2555. Article 11 provides that "[i]n the execution of a Letter of Request the person concerned may refuse to give evidence in so far as he has a privilege or duty to refuse to give the evidence ... under the law of the State of execution.â Id. art. 11. And, Article 12 provides that "[t]he execution of a Letter of Request may be refused only to the extent that ... the
. The special master commented: "Petitionersâ failure to request to reopen the evidentiary record to present the ... 'new evidence' prior to the decision issuing in this case says volumes about the value of this evidence to any causation decision and speaks loudly about the motivation for the untimely filing.â Ruling Mot. Recons. (âRulingâ) 2 n. 2, Mar. 16, 2009.
. In so ruling, the special master remarked: "The untimely filing of this motion for reconsideration, on the eve of the deadline for filing a motion for review of my decision, suggests a thinly veiled effort by petitionersâ counsel to obtain additional time for filing their motion for review, while placing additional evidence before the court.â Ruling 2; see also id. at 2 n. 4 (noting that if a special master grants a motion for reconsideration, he or she must withdraw the underlying decision, rendering it "void for all purposes, including the triggering of the 30 day period for filing an appealâ).
. For this reason, the court has disregarded all of the references and citations in petitioners' motion for review to the evidence submitted with their motion for reconsideration. See, e.g., Mot. 35 n. 52, 44, 48-49.
. Subsection (c)(1) requires, among other things, that the following elements be satisfied: (1) that the vaccine in question is set forth in the Vaccine Injury Table ("Table"); (2) that the vaccine was received in the United States or in its trust territories; (3) that the injured person either sustained an injury as a result of the administration of a Table-designated vaccine for a period of more than six months after the administration of the vaccine, suffered illness, disability, injury, or condition from the vaccine that resulted in inpatient hospitalization and surgical intervention, or died from the administration of the vaccine; and (4) that the petitioner has not previously collected an award or settlement of a civil action for damages arising from the alleged âvaccine-related injury or death. 42 U.S.C. § 300aa-l 1(c)(1).
. Elsewhere in their motion for review, petitioners commented that it was "fundamentally unfairâ for the special master to apply Dauben to find "virtually all of Colten's evidence unreliable.â Mot. 11. When determining fundamental fairness to the parties, there is no direct correlation between the sheer volume of evidence offered and amount of evidence that must be admitted and ultimately credited at hearing. Merely because a party offers a huge volume of evidence does not mean that the special master is duty bound to accept any of that material as persuasive. It is hardly unusual for diametrically opposed expert views to be admitted as evidence at hearing. However, it is up to the trier of fact to weigh and credit that evidence. As the Court of Federal Claims has explained, "[s]imply because a witness is found qualified to testify as an expert does not mean that the trier of fact must accept his testimony.â Ultimo, 28 Fed.Cl. at 151.
Here, petitioners, in effect, offer a numbers challenge to the manner in which the special master weighed and credited evidence. According to petitioners, because a large amount of their evidence was not accepted by the special master, that fact, in and of itself, establishes that she committed error. Taking petitioners' view to its logical conclusion, in order to demonstrate fundamental fairness, a special master would be required to admit and credit a certain, unspecified percentage of the evidence proffered at hearing. Thus, the notion of fundamental fairness would be reduced to nothing more that an examination of percentage rate for the admission and acceptance of evidence, i.e., a quota. Petitionersâ unsound construct is contrary to established law. At hearing, a special master must determine not only the admissibility of evidence, but how to weigh and credit that evidence, even if it is offered by a properly credentialed expert witness.
. Petitioners' contention that the sole basis for the special master's dismissal of their proffered medical theory was that it was not generally accepted by the medical community, Mot. 19, lacks merit.
. The special master noted several instances of rĂ©sumĂ© padding, as well as several occasions where petitioners' experts testified outside their stated expertise. See, e.g., Snyder, 2009 WL 332044, at *10 ("Dr. Kennedy ... tended to offer opinions outside his areas of expertise.â), 14 (âDoctor Byers' credibility was not enhanced by several instances of 'resume padding.' â), 15 (noting that Dr. Byers "strayed into matters beyond her expertiseâ), 17 (noting that while Dr. Krigsman's curriculum vitae listed four publications, only one was a published article, and that the other three consisted of an unpublished article, a âslide presentation," and a "poster and abstract of preliminary data").
. The special master indicated that while the testimony of petitionersâ experts was often sincere and heartfelt, it was, at times, speculative. See, e.g., Snyder, 2009 WL 332044, at * 12 ("Doctor Corbier presented as an earnest and sincere witness, albeit one whose expert opinions were heavily laced with generalities, speculation, and conjecture.â), 17 ("Dr. Krigsmanâs testimony about autistic enterocolitis as a diagnostic entity was speculative and unsupported by the weight of the evidence.â). Daubert clearly envisions the exclusion of evidence that amounts to nothing more than speculation. See 509 U.S. at 590, 113 S.Ct. 2786 (noting that scientific evidence must be "more than subjective belief or unsupported speculationâ); see also Gen. Elec. Co., 522 U.S. at 146, 118 S.Ct. 512 ("[Njothing in ... Daubert ... requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert.â); Perreira ex rel. Peireira v. Sec'y of HHS, 33 F.3d 1375, 1377 n. 6 (Fed.Cir.1994) ("An expert opinion is no better than the soundness of the reasons supporting it.â (citing Daubert, 509 U.S. at 579, 113 S.Ct. 2786)).
. After briefing had concluded on petitionersâ motion for review, but prior to oral argument, the Federal Circuit issued its decision in Andreu, reaffirming its prior holdings that the testimony of treating physicians is " 'quite probativeâ since 'treating physicians are likely to be in the best position to determine whether a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.' â 569 F.3d at 1375 (quoting Capizzano, 440 F.3d at 1326, and citing Althen, 418 F.3d at 1279-80; Zatuchni v. Secây of HHS, 69 Fed.Cl. 612, 623 (2006)). However, there is nothing in Andreu that mandates that the testimony of a treating physician is sacrosanctâ that it must be accepted in its entirety and cannot be rebutted. Indeed, the Federal Circuit did not disturb its prior holdings concerning the deference accorded the special mastersâ findings of facts. In any event, petitioners did not raise Andreuâs discussion of treating physicians at oral
. Although petitioners are complaining about the number of expert witnesses presented by respondent here, they later insist that "they did not â and do not â object to the number of presentations of the many highly qualified scientists retained by the respondent." Mot. 27. This is obviously not the case. See also id. at 5 ("[T]he respondent presented the opinions of seventeen (17!) expert witnesses_â (exclamation in the original)), 19 (arguing that the special master "simply accepted the conclusions of the respondentâs seventeen expertsâ). Relatedly, the court notes that there is no evidence that the special master limited either party in the number of expert witnesses they could present.
. At oral argument, the court asked petitionersâ counsel â Mr. Powers â whether he "stood by [his] statement that Colten was 'sacrificed' to protect the integrity of vaccines." Oral Argument Tr. 33. He answered in the negative, subsequently stating: "I am willing ..., more removed in time from preparing that brief, if I wrote it again, I would probably change the words that I used.â Id. at 34.
.In their motion for review, petitioners provide no citations to the record or other evidence to support their claims. They do quote a speech made by the Chief Special Master in a nonlitiga-tive context, Mot. 20, but such reliance is improper because the speech is not in the record and there is no indication that anything in that speech reflects the views of Special Master Vo-well. In light of petitionersâ failure to support their bias claim in their motion for review, they sought to provide some clarification to their allegations at oral argument, as discussed in the text above.