VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_04-vv-01717
Package ID: USCOURTS-cofc-1_04-vv-01717
Petitioner: C.A.P.
Filed: 2004-11-29
Decided: 2019-06-18
Vaccine: DTaP
Vaccination date: 2002-07-22
Condition: encephalopathy
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
On November 29, 2004, Chris and Ellena Prokopeas, parents of C.A.P., a minor born December 6, 2001, filed a petition for compensation under the National Vaccine Injury Compensation Program. They alleged that C.A.P. received DTaP, Hib, IPV, Prevnar, and Hep B vaccines on February 5, 2002, April 9, 2002, July 22, 2002, and September 24, 2002, which caused him to develop encephalopathy. Initially, the petition was part of the Omnibus Autism Proceeding (OAP), alleging autism. After the OAP test cases were decided against petitioners, they amended their petition in 2011 to allege Table encephalopathy and an off-Table causation-in-fact theory. This case was the last OAP-rooted case remaining in the Office of Special Masters. Special Master Hastings issued a Ruling on Factual Issues on June 14, 2017, making factual findings adverse to petitioners. The case was reassigned to Chief Special Master Dorsey after Special Master Hastings retired. In 2018, petitioners sought to amend again to allege a mitochondrial metabolism disorder, but mitochondrial DNA testing showed no clinically significant variants and was interpreted as normal. The final decision, issued by Chief Special Master Dorsey on June 18, 2019, dismissed the petition. The Special Master found that C.A.P.'s contemporaneous medical records did not demonstrate the acute encephalopathy required for a Table injury; his post-vaccination symptoms were a mild febrile reaction, and he was generally described as "happy and playful." The off-Table causation theories presented by Dr. Bellanti (allergic/immune-mediated reactions) and Dr. Corbier (vaccine preservatives and adjuvants) were rejected because the medical records did not document any allergic reaction, encephalopathy was not documented until over a year post-vaccination, and a later note attributed C.A.P.'s symptoms to "post-concussion syndrome" following a head injury. The mitochondrial disorder theory lacked genetic testing support. Petitioners did not satisfy any of the three Althen prongs for causation-in-fact. The petition was dismissed for insufficient proof. The court acknowledged the petitioners' "remarkable patience and dedication" over nearly fifteen years of litigation. Petitioners were represented by Curtis Webb, and respondent was represented by Voris Johnson. Chief Special Master Nora Beth Dorsey issued the final decision.

Theory of causation field:
Petitioners alleged that DTaP, Hib, IPV, Prevnar, and Hep B vaccinations administered on February 5, April 9, July 22, and September 24, 2002, caused C.A.P. to develop encephalopathy, initially as part of the Omnibus Autism Proceeding, and later alleging Table encephalopathy and off-Table causation-in-fact. Petitioners also later alleged a mitochondrial metabolism disorder. Chief Special Master Dorsey dismissed the petition, finding that contemporaneous medical records did not support acute encephalopathy for a Table injury, as C.A.P. exhibited only mild febrile reactions and was described as happy and playful post-vaccination. Off-Table theories from petitioners' experts Dr. Bellanti (allergic/immune-mediated reactions) and Dr. Corbier (vaccine preservatives/adjuvants) were rejected due to lack of documentation of allergic reactions, delayed encephalopathy diagnosis (over a year post-vaccination), and a conflicting diagnosis of post-concussion syndrome. The mitochondrial disorder theory was unsupported by genetic testing, which showed normal results. Petitioners failed to satisfy the three Althen prongs for causation-in-fact. The decision was issued by Chief Special Master Nora Beth Dorsey on June 18, 2019. Petitioners were represented by Curtis Webb and Voris Johnson represented the respondent. The public decision does not describe the specific mechanism of injury, onset, symptoms, or diagnostic tests beyond the mitochondrial DNA test, nor does it name all experts consulted by the parties.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_04-vv-01717-0
Date issued/filed: 2017-07-18
Pages: 47
Docket text: PUBLIC DECISION (Originally filed: 06/14/2017) regarding 131 Findings of Fact & Conclusions of Law Signed by Special Master George L. Hastings. (dj) Copy to parties.
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Case 1:04-vv-01717-UNJ Document 135 Filed 07/18/17 Page 1 of 47
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 04-1717V
(To be published)
* * * * * * * * * * * * * * * * * * * * * * * * *
*
ELLENA PROKOPEAS and *
CHRIS PROKOPEAS, *
parents of C.A.P., a minor, *
* Filed: June 14, 2017
*
Petitioners, *
*
v. * Ruling on factual issues; Autism
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Clifford Shoemaker, Shoemaker, Gentry & Knickelbein, Vienna, VA, for Petitioners
Voris Johnson, U.S. Department of Justice, Washington, DC, for Respondent
RULING ON FACTUAL ISSUES
HASTINGS, Special Master.
This is an action in which the Petitioners, Ellena and Chris Prokopeas, request
compensation under the National Vaccine Injury Compensation Program (hereinafter “the
Program”1), on behalf of their minor son, C.A.P., for injuries allegedly suffered from
vaccinations administered to him during his first year of life. C.A.P.’s vaccinations to which
Petitioners point include the following: diphtheria-tetanus-acellular pertussis (DTaP),
haemophilus influenza (Hib), inactivated polio (IPV), pneumococcal conjugate (Prevnar), and
hepatitis B (Hep B) vaccines. Petitioners allege that C.A.P. suffered from an encephalopathy
that was “caused-in-fact” by the cumulative effects of those vaccinations. Among C.A.P.’s
many neurodevelopmental conditions, he has been diagnosed with an autism spectrum disorder
(ASD).
1 The applicable statutory provisions defining the Program are found at 42 U.S.C. § 300aa-
10 et seq. (2012 ed.). Hereinafter, for ease of citation, all "§" references will be to 42 U.S.C.
(2012 ed.). I will also sometimes refer to the statutory provisions defining the program as the
“Vaccine Act.”
1

Case 1:04-vv-01717-UNJ Document 135 Filed 07/18/17 Page 2 of 47
In this case, Petitioners presented certain facts concerning C.A.P.’s symptomatology from
the early years of his life that are at variance with his contemporaneous medical records. Thus, a
“fact hearing” was held on August 1, 2016, to resolve the disputed facts. For all of the reasons
set forth below, I find that C.A.P.’s contemporaneous medical records are the most reliable
source of evidence reflecting C.A.P.’s condition during his first year of life. In this regard, I
reject parental allegations made during the course of this litigation, alleging that C.A.P. suffered
from additional post-vaccination symptoms not reflected in his contemporaneous medical
records.
I
THE APPLICABLE STATUTORY SCHEME
I begin with the relevant law concerning this “fact ruling,” which states that Petitioners
are required to establish the facts supporting their causation theory by a “preponderance of the
evidence.” 42 U.S.C. § 300aa–13(a)(1)(a). The preponderance of the evidence standard requires
a “trier of fact to believe that the existence of a fact is more probable than its nonexistence before
[he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly v. HHS, 592 F.3d 1315, 1322, n.2 (Fed. Cir. 2010) (citations omitted).
When confronted with discrepancies among medical records and affidavits, special
masters often elect to hold “fact hearings” to evaluate the testimony of the affiants. See Campbell
v. HHS, 69 Fed. Cl. 775, 779-80 (2006). The process for finding facts in the Vaccine Program
begins with analyzing the medical records, which are required to be filed with the petition. 42
U.S.C. § 300aa–11(c)(2). In this regard, the relevant caselaw states that medical records
“warrant consideration as trustworthy evidence.” Cucuras v. HHS, 993 F.2d 1525, 1528 (Fed.
Cir. 1993). Accordingly, where subsequent testimony conflicts with contemporaneous medical
records, special masters usually accord more weight to the medical records. See, e.g., Reusser v.
HHS, 28 Fed. Cl. 516, 523 (Fed. Cl. 1993) (“[W]ritten documentation recorded by a disinterested
person at or soon after the event at issue is generally more reliable than the recollection of a party
to a lawsuit many years later.”).
To be sure, “it must [also] be recognized that the absence of a reference to a condition or
circumstance is much less significant than a reference which negates the existence of the
condition or circumstance. Since medical records typically record only a fraction of all that
occurs, the fact that reference to an event is omitted from the medical records may not be very
significant.” Murphy v. HHS, 23 Cl. Ct. 726, 733 (Fed. Cl. 1991), aff’d, 968 F.2d 1226 (Fed. Cir.
1992). However, in balancing these considerations, special masters in this Program have in most
cases declined to credit later testimony over contemporaneous records. See, e.g., Stevens v. HHS,
No. 90-221V, 1990 WL 608693, at *3 (Cl. Ct. Spec. Mstr. Dec. 21, 1990); Vergara v. HHS, No.
08-882V, 2014 WL 2795491, at *4 (Fed. Cl. Spec. Mstr. July 17, 2014) (“Special Masters
frequently accord more weight to contemporaneously-recorded medical symptoms than those
recorded in later medical histories, affidavits, or trial testimony.”); see also Cucuras v. HHS, 993
F.2d 1525, 1528 (Fed. Cir. 1993) (noting that “the Supreme Court counsels that oral testimony in
conflict with contemporaneous documentary evidence deserves little weight”).)
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Case 1:04-vv-01717-UNJ Document 135 Filed 07/18/17 Page 3 of 47
Decisions by judges of the Court of Federal Claims have followed Cucuras in affirming
findings by special masters that the lack of symptoms being reported in contemporaneously
created medical records can contradict a testimonial assertion that symptoms appeared on a
certain date. See, e.g., Doe/70 v. HHS, 95 Fed. Cl. 598, 608 (2010) (stating, “[g]iven the
inconsistencies between petitioner’s testimony and his contemporaneous medical records, the
special master’s decision to rely on petitioner’s medical records was rational and consistent with
applicable law”), aff’d sub nom. Rickett v. HHS, 468 Fed. Appx. 952 (Fed. Cir. 2011); Doe/17 v.
HHS, 84 Fed. Cl. 691, 711 (2008); Ryman v. HHS, 65 Fed. Cl. 35, 41-42 (2005); Snyder v. HHS,
36 Fed. Cl. 461, 465 (1996) (“[t]he special master apparently reasoned that, if Frank suffered
such [developmental] losses immediately following the vaccination, it was more likely than not
that this traumatic event, or his parents’ mention of it, would have been noted by at least one of
the medical record professionals who evaluated Frank during his life to date. Finding Frank’s
medical history silent on his loss of developmental milestones, the special master questioned
petitioner’s memory of the events, not her sincerity.”), aff’d, 117 F.3d 545, 547-48 (Fed. Cir.
1997).
The presumption that contemporaneously-created medical records are accurate and
complete is rebuttable, of course. Special masters are expected to consider whether medical
records are accurate and complete. To overcome the presumption that written records are
accurate, testimony is required to be “consistent, clear, cogent, and compelling.” Blutstein v.
HHS, No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). Special
masters will consider various explanations for inconsistencies between contemporaneously
created medical records and later given testimony. The Court of Federal Claims listed four such
explanations. Inconsistencies can be explained by: (1) a person’s failure to recount to the
medical professional everything that happened during the relevant time period; (2) the medical
professional’s failure to document everything reported to her or him; (3) a person’s faulty
recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of
symptoms that did not exist. La Londe v. HHS, 110 Fed. Cl. 184, 203 (Fed. Cl. 2013), aff’d, 746
F.3d 1334 (Fed. Cir. 2014).
In weighing divergent pieces of evidence, special masters usually find
contemporaneously-written medical records to be more significant than oral testimony. Cucuras,
993 F.2d at 1528. Testimony offered after the events in question is less reliable than
contemporaneous reports when the motivation for accurate explication of symptoms is more
immediate. Reusser v. HHS, 28 Fed. Cl. 516, 523 (1993). However, compelling oral testimony
may be more persuasive than written records. Campbell, 69 Fed. Cl. at 779 (“[l]ike any norm
based upon common sense and experience, this rule should not be treated as an absolute and
must yield where the factual predicates for its application are weak or lacking.”); Camery v.
HHS, 42 Fed. Cl. 381, 391 (1998) (this rule “should not be applied inflexibly, because medical
records may be incomplete or inaccurate”).
3

Case 1:04-vv-01717-UNJ Document 135 Filed 07/18/17 Page 4 of 47
II
BACKGROUND: THE OMNIBUS AUTISM PROCEEDING (“OAP”)
This case is one of more than 5,400 cases filed under the Program in which petitioners
alleged that conditions known as “autism” or “autism spectrum disorders” (“ASD”)2 were caused
by one or more vaccinations. A special proceeding known as the Omnibus Autism Proceeding
(“OAP”) was developed to manage these cases within the Office of Special Masters (“OSM”). A
detailed history of the controversy regarding vaccines and autism, along with a history of the
development of the OAP, was set forth in the six entitlement decisions issued as “test cases” for
two theories of causation litigated in the OAP (see cases cited below), and will only be
summarized here.
A group called the Petitioners’ Steering Committee (“PSC”) was formed in 2002 by the
many attorneys who represented Vaccine Act petitioners who raised autism-related claims.
About 180 attorneys participated in the PSC. Their responsibility was to develop any available
evidence indicating that vaccines could contribute to causing autism, and eventually present that
evidence in a series of “test cases,” exploring the issue of whether vaccines could cause autism,
and, if so, in what circumstances. Ultimately, the PSC selected groups of attorneys to present
evidence in two different sets of “test cases” during many weeks of trial in 2007 and 2008. In
the six test cases, the PSC presented two separate theories concerning the causation of ASDs.
The first theory alleged that the measles portion of the measles, mumps, rubella (“MMR”)
vaccine could cause ASDs. That theory was presented in three separate Program test cases
during several weeks of trial in 2007. The second theory alleged that the mercury contained in
thimerosal-containing vaccines could directly affect an infant’s brain, thereby substantially
contributing to the causation of ASD. That theory was presented in three additional test cases
during several weeks of trial in 2008.
Decisions in each of the three test cases pertaining to the PSC’s first theory rejected the
petitioners’ causation theories. Cedillo v. HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec.
Mstr. Feb. 12, 2009) aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010);
2 “Autism Spectrum Disorder” is a general classification which as of 2010 included five
different specific disorders: Autistic Disorder, Childhood Disintegrative Disorder, Asperger’s
Syndrome, Rett Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified
(PDD-NOS). King v. HHS, No. 03-584V, 2009 WL 892296 at *5 (Fed. Cl. Spec. Mstr. Feb. 12,
2010). The term “autism” is often utilized to encompass all of the types of disorders falling
within the autism spectrum. (Id.) I recognize that since the OAP test cases, the consensus
description of ASDs, contained now in the “DSM-V” as opposed to the prior “DSM-IV,” revises
the prior subcategories of ASD set forth in the first sentence of this footnote. However, the
DSM-V retains the same general description of ASDs. An ASD is a serious form of
neurodevelopmental disorder defined by a collection of symptoms and behaviors, including
significant impairment of social interaction and language skills, and the presence of repetitive,
stereotyped interests. E.g., Snyder v. HHS, No. 01-162V, 2009 WL 332044, at *31 (Fed. Cl.
Spec. Mstr. Feb. 12, 2009).
4

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Hazlehurst v. HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d
88 Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. HHS, No. 01-162V,
2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009).3 Decisions
in each of the three “test cases” pertaining to the PSC’s second theory also rejected the
petitioners’ causation theories, and the petitioners in each of those three cases chose not to
appeal. Dwyer v. HHS, No. 03-1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010);
King v. HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar 12, 2010); Mead v.
HHS, No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12, 2010).
The “test case” decisions were comprehensive, analyzing in detail all of the evidence
presented on both sides. The three test case decisions concerning the PSC’s first theory
(concerning the MMR vaccine) totaled more than 600 pages of detailed analysis, and were
solidly affirmed in many more pages of analysis in three different rulings by three different
judges of the United States Court of Federal Claims, and in two rulings by two separate panels of
the United States Court of Appeals for the Federal Circuit. The three special master decisions
concerning the PSC’s second theory (concerning vaccinations containing the preservative
“thimerosal”) were similarly comprehensive.
All told, the 11 lengthy written rulings by the special masters, the judges of the U.S.
Court of Federal Claims, and the panels of the U.S. Court of Appeals for the Federal Circuit
unanimously rejected the petitioners’ claims, finding no persuasive evidence that either the
MMR vaccine or thimerosal-containing vaccines could contribute in any way to the causation of
autism.
Thus, the proceedings in the six “test cases” concluded in 2010. Thereafter, the Petitioners
in this case, and the petitioners in other cases within the OAP, were instructed to decide how to
proceed with their own claims. The vast majority of those autism petitioners elected either to
withdraw their claims or, more commonly, to request that the special master file a decision denying
their claim on the written record, resulting in a decision rejecting the petitioner’s claim for lack of
support. However, a small minority of the autism petitioners have elected to continue to pursue
their cases, seeking other causation theories and/or other expert witnesses. A few such cases have
gone to trial before a special master, and in the cases of this type decided thus far, all have resulted
in rejection of petitioners’ claims that vaccines played a role in causing their child’s autism. See,
e.g., Henderson v. HHS, No. 09-616V, 2012 WL 5194060 (Fed. Cl. Spec. Mstr. Vowell Sept. 28,
2012) (autism not caused by pneumococcal vaccination); Blake v. HHS, No. 03-31V, 2014 WL
2769979 (Fed. Cl. Spec. Mstr. Vowell May 21, 2014) (autism not caused by MMR vaccination);
Murphy v. HHS, No. 05-1063V, 2016 WL 3034047 (Fed. Cl. Spec. Mstr. Corcoran Apr. 25, 2016)
(autism not caused by DTaP or MMR vaccines), aff’d, 2016 WL 4926207 (Fed. Cl. Aug. 15, 2016);
Franklin v. HHS, No. 99-855V, 2013 WL 3755954 (Fed. Cl. Spec. Mstr. Hastings May 16, 2013)
(MMR and other vaccines found not to contribute to autism); Coombs v. HHS, No. 08-818V, 2014
WL 1677584 (Fed. Cl. Spec. Mstr. Hastings Apr. 8, 2014) (autism not caused by MMR or Varivax
vaccines); Long v. HHS, No. 08-792V, 2015 WL 1011740 (Fed. Cl. Spec. Mstr. Hastings Feb. 19,
2015) (autism not caused by influenza vaccine); Brook v. HHS, No. 04-405V, 2015 WL 3799646
(Fed. Cl. Spec. Mstr. Hastings May 14, 2015) (autism not caused by MMR or Varivax vaccines);
3 The petitioners in Snyder did not appeal the decision of the U.S. Court of Federal Claims.
5

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Holt v. HHS, No. 05-136V, 2015 WL 4381588 (Fed. Cl. Spec. Mstr. Vowell June 24, 2015) (autism
not caused by hepatitis B vaccine), aff’d, (not yet published); Lehner v. HHS, No. 08-554V, 2015
WL 5443461 (Fed. Cl. Spec. Mstr. Vowell July 22, 2015) (autism not caused by influenza
vaccine); Miller v. HHS, No. 02-235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. Vowell August
18, 2015) (ASD not caused by combination of vaccines); Allen v HHS, No. 02-1237V, 2015 WL
6160215 (Fed. Cl. Spec. Mstr. Vowell Sept. 26, 2015) (autism not caused by MMR vaccination);
R.K. v. HHS, No. 03-632V, 2015 WL 10936124 (Fed. Cl. Spec. Mstr. Vowell Sept. 28, 2015)
(autism not caused by influenza vaccine), aff’d, 125 Fed. Cl. 57 (2016), aff’d, 2016 WL 7174139
(Fed. Cir. Dec. 9, 2016); Hardy v. HHS, No. 08-108V, 2015 WL 7732603 (Fed. Cl. Spec. Mstr.
Hastings Nov. 3, 2015) (autism not caused by several vaccines); Sturdivant v. HHS, No. 07-788V,
2016 WL 552529 (Fed. Cl. Spec. Mstr. Hastings Jan. 21, 2016) (autism not caused by Hib and
Prevnar vaccines); R.V. v. HHS, No. 08-504V, 2016 WL 3882519 (Fed. Cl. Spec. Mstr. Corcoran
Feb. 19, 2016) (autism not caused by influenza vaccine), aff’d, 2016 WL 3647786 (Fed. Cl. June
2, 2016); Cunningham v. HHS, No. 13-483V, 2016 WL 4529530 (Fed. Cl. Spec. Mstr. Hastings
Aug. 1, 2016) (autism not caused by MMR vaccine), aff’d, 2017 WL 1174448 (Fed. Cl. Jan. 25,
2017); T.M. v. HHS, No. 08-284V (Fed. Cl. Spec. Mstr. Corcoran Aug. 9, 2016) (not yet published)
(autism not caused by DTaP vaccine) (on review); Anderson v. HHS, 02-1314V, 2016 WL
8256278 (Fed. Cl. Spec. Mstr. Corcoran Nov. 1, 2016) (autism not caused by MMR vaccination),
aff’d, 2017 WL 1787975 (Fed. Cl. May 5, 2017); Dempsey v. HHS, No. 04-394V, 2017 WL
105840 (Fed. Cl. Spec. Mstr. Hastings Feb. 23, 2017).
In addition, some autism causation claims have been rejected without trial, at times over
the petitioner’s objection, in light of the failure of the petitioner to file plausible proof of
vaccine-causation. See, e.g., Waddell v. HHS, No. 10-316V, 2012 WL 4829291 (Fed. Cl. Spec.
Mstr. Campbell-Smith Sept. 19, 2012) (autism not caused by MMR vaccination); Fester v. HHS,
No. 10-243V, 2016 WL 1745436 (Fed. Cl. Spec. Mstr. Dorsey April 7, 2016) (autism not caused
by measles, mumps, rubella, and varicella (MMRV) vaccine); Fresco v. HHS, No. 06-469V,
2013 WL 364723 (Fed. Cl. Spec. Mstr. Vowell Jan. 7, 2013) (autism not caused by multiple
vaccines); Fesanco v. HHS, No. 02-1770, 2010 WL 4955721 (Fed. Cl. Spec. Mstr. Hastings
Nov. 9, 2010) (autism not caused by multiple vaccines); Miller v. HHS, No. 06-753V, 2012 WL
12507077 (Fed. Cl. Spec. Mstr. Hastings Sept. 25, 2012) (autism not caused by DTaP or MMR
vaccines); Pietrucha v. HHS, No. 00-269V, 2014 WL 4538058 (Fed. Cl. Spec. Mstr. Hastings
Aug. 22, 2014) (autism not caused by multiple vaccines); Bushnell v. HHS, No. 02-1648, 2015
WL 4099824 (Fed. Cl. Spec. Mstr. Hastings June 12, 2015) (autism not caused by multiple
vaccines); Bokmuller v. HHS, No. 08-573, 2015 WL 4467162 (Fed. Cl. Spec. Mstr. Hastings
June 26, 2015) (autism not caused by multiple vaccines); Canuto v. HHS, No. 04-1128, 2015 WL
9854939 (Fed. Cl. Spec. Mstr. Hastings Dec. 18, 2015) (autism not caused by DTP and DTaP
vaccines); Valle v. HHS, No. 02-220V, 2016 WL 2604782 (Fed. Cl. Spec. Mstr. Hastings April
13, 2016) (autism not caused by DTaP vaccine); Hooker v. HHS, 02-472V, 2016 WL 3456435
(Fed. Cl. Spec. Mstr. Hastings May 19, 2016) (autism not caused by multiple vaccines). Judges
of this court have affirmed the practice of dismissal without trial in such cases. E.g., Fesanco v.
HHS, 99 Fed. Cl. 28 (2011) (Judge Braden affirming); Canuto v. HHS, No. 04-1128V, 2016 WL
2586510 (Fed. Cl. Apr. 18, 2016) (Judge Yock affirming), aff’d, 2016 WL 5746370 (Fed. Cir.
Oct. 4, 2016).
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In none of the rulings since the test cases has a special master or judge found any merit in
an allegation that any vaccine can contribute to causing autism.4
III
PROCEDURAL HISTORY
A. Petitioners’ filing of a “Short-Form Autism Petition”
On November 29, 2004, Chris and Ellena Prokopeas (“Petitioners”) filed a Short-
Form Autism Petition for Vaccine Compensation on behalf of their minor son, C.A.P. (ECF No.
1.) This case was assigned to my docket at that time. By filing that “Short Form” petition,
4 I am well aware, of course, that during the years since the “test cases” were decided, in
two cases involving vaccinees suffering from ASDs, Vaccine Act compensation was granted.
But in neither of those cases did the Respondent concede, nor did a special master find, that there
was any “causation-in-fact” connection between a vaccination and the vaccinee’s ASD. Instead,
in both cases it was conceded or found that the vaccinee displayed the symptoms of a Table
Injury within the Table time frame after vaccination. (See Section I above).
In Poling v. HHS, the presiding special master clarified that the family was compensated
because the Respondent conceded that the Poling child had suffered a Table Injury--not because
the Respondent or the special master had concluded that any vaccination had contributed to
causing or aggravating the child’s ASD. See Poling v. HHS, No. 02-1466V, 2011 WL 678559,
at *1 (Fed. Cir Spec. Mstr. Jan. 28, 2011) (a fees decision, but noting specifically that the case
was compensated as a Table Injury).
Second, in Wright v. HHS, No. 12-423, 2015 WL 6665600 (Fed. Cl. Spec. Mstr. Sept. 21,
2015), Special Master Vowell concluded that a child, later diagnosed with ASD, suffered a
“Table Injury” after a vaccination. However, she stressed that she was not finding that the
vaccinee’s ASD in that case was “caused-in-fact” by the vaccination--to the contrary, she
specifically found that the evidence in that case did not support a “causation-in-fact” claim,
going so far as to remark that the petitioners’ “causation-in-fact” theory in that case was
“absurd.” Wright v. HHS, No. 12-423, 2015 WL 6665600, at *2 (Fed. Cl. Spec. Mstr. Sept. 21,
2015).
The compensation of these two cases, thus, does not afford any support to the notion that
vaccinations can contribute to the causation of autism. In setting up the Vaccine Act
compensation system, Congress forthrightly acknowledged that the Table Injury presumptions
would result in compensation for some injuries that were not, in fact, truly vaccine-caused. H.R.
Rept. No. 99-908, 18, 1986 U.S.C.C.A.N. 6344, 6359. (“The Committee recognizes that there is
public debate over the incidence of illnesses that coincidentally occur within a short time of
vaccination. The Committee further recognizes that the deeming of a vaccine-relatedness
adopted here may provide compensation to some children whose illness is not, in fact, vaccine-
related.”)
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Petitioners in effect alleged that C.A.P. suffered from autism, and that his autism was caused by
either or both (1) the MMR (measles, mumps, rubella) vaccine, and (2) vaccines containing
“thimerosal”, a mercury-based preservative contained in a number of childhood vaccines until
about 1999 (but removed from most childhood vaccines soon after that year). Autism General
Order #1, Exhibit A, Master Autism Petition for Vaccine Compensation, 2002 WL 31696785, at
*8 (Fed. Cl. Spec. Mstr. July 3, 2002). By filing the “Short Form” petition, the Petitioners also
were, in effect, making their case part of the “Omnibus Autism Proceeding” (OAP). On
December 8, 2004, this case, along with many others, was stayed indefinitely pending
completion of the general inquiry under the Omnibus Autism Proceeding (OAP) regarding the
possible causal relationship between certain vaccines and autistic spectrum disorders. (ECF No.
2; See also Section II of the Fact Ruling above.)
On January 26, 2007, this case was reassigned to Special Master Campbell-Smith. (ECF
No. 12.) Thereafter, Petitioners filed medical records (marked as Exhibits 1 to 16) on September
24, 2007. (ECF No. 13.)
On October 15, 2008, Special Master Campbell-Smith issued an order updating
Petitioners on the status of the OAP and explaining how their case would proceed. (ECF No. 14.)
Between May of 2009 and August of 2010, Petitioners submitted numerous medical records.
(See Exs. 17-575; ECF Nos. 22-23, 25, 34-35, 39, 41, 43-45.)
Petitioners filed a statement on August 20, 2010, indicating that they had filed all
requested records ordered by the special master. (ECF No. 46.) Thereafter, on September 16,
2010, Respondent submitted a statement indicating that she would not oppose further processing
of this case. (ECF No. 47, p. 3.)
B. First and second Amended Petitions
In light of the OAP “test cases,” on June 14, 2011, Special Master Campbell-Smith
issued an order requiring the Petitioners to state whether they wished to pursue their claim
further. (ECF No. 48.) That order also instructed that, if the Petitioners wished to proceed
further with this case, then they should file an Amended Petition, which, among other things,
clearly explained their theory of vaccine causation. (Id.)
Petitioners filed an Amended Petition on August 15, 2011, alleging that C.A.P.
“developed encephalopathy from repeated exposures to mercury and other vaccine ingredients”
found in certain vaccinations C.A.P. received during his first year of life. (ECF No. 51, p. 3.)
The vaccinations alleged to have caused C.A.P.’s injuries included: diphtheria-tetanus-acellular
pertussis (DTaP), haemophilus influenzae (Hib), inactivated polio (IPV), pneumococcal
conjugate (Prevnar), and hepatitis B (Hep B). (Id., pp. 2-3.)
On January 11, 2012, Special Master Campbell-Smith held a status conference to discuss
her concerns about the Petitioners’ claim. (ECF No. 54.) Specifically, she noted that
Petitioners’ causation theory in this case, alleging that C.A.P. developed an “encephalopathy
5 Petitioners filed Exhibit 54 on both July 26, 2010 and July 29, 2010. (ECF Nos. 41, 43.)
On July 29, 2010, Petitioners moved to strike the documents filed on July 26, 2010, due to an
inadvertent filing mistake by Petitioners’ counsel. (ECF No. 42.)
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from repeated exposure to mercury and other vaccine ingredients,” was “without more, a reprise
of aspects of theories asserted, considered, and rejected in both the first and second rounds of test
cases litigated during the Omnibus Autism Proceeding (OAP).” (Id.) Moreover, she highlighted
her concern that “there is a lack of factual support for the allegation that [C.A.P.] had a fever
following the administration of vaccines.” (Id., p. 2.) Thus, she ordered Petitioners to (1) file
updated medical records supporting the allegation that C.A.P. suffered fevers following the
administration of his vaccinations, and (2) an annotated Amended Petition containing specific
citations to the supporting medical records. (Id.)
In response, on March 12, 2012, Petitioners filed a joint affidavit from Chris and Ellena
Prokopeas (Ex. 58, ECF No. 56), and a second Amended Petition (ECF No. 57), virtually
identical to the Amended Petition filed on August 15, 2011, except that it added certain citations
to the exhibits. Between June of 2012 and September of 2012, Petitioners submitted numerous
updated medical records (Exs. 59-86; ECF Nos. 60, 63-67). This case was then reassigned to the
docket of Special Master Vowell on March 8, 2013. (ECF No. 70.)
C. Expert reports and evidentiary hearing
On July 9, 2013, Petitioners filed the expert report and curriculum vitae of Dr. Joseph
Bellanti, M.D. (Exs. 87-88; ECF No. 72.) Dr. Bellanti’s expert report of July 9, 2013, however,
indicated that his opinion was “subject to further consultation with colleagues in the field of
genetics.” (ECF No. 73.) Thus, on July 12, 2013, Special Master Vowell ordered Petitioners to
file a supplemental report from Dr. Bellanti addressing the aforementioned statement contained
in that expert report. (Id.) After several extensions of time (ECF Nos. 74-75, 78), Petitioners
eventually filed the supplemental expert report of Dr. Bellanti on February 12, 2014 (Ex. 89;
ECF No. 80).
On June 3, 2014, Respondent filed the expert reports and curricula vitae of Dr. Gerald
Raymond, M.D. (Exs. A-B), and of Dr. Judith Miller, Ph.D. (Exs. H-I). (ECF No. 83.)
Additionally, Respondent also filed medical literature supporting both Dr. Raymond’s expert
report (Exs. C-G), and Dr. Miller’s expert report (Exs. J-K). (Id.)
On September 16, 2014, Special Master Vowell ordered Petitioners to file all outstanding
medical records, including C.A.P.’s most recent lab results and reports from C.A.P.’s genetic
specialist. (ECF No. 88.) Petitioners continued to file outstanding medical records from October
to December of 2014. (Exs. 90-91, 93; ECF Nos. 89, 91, 93.) Thereafter, on February 13, 2015,
Petitioners filed medical records6 from C.A.P.’s treating geneticist, Dr. Aparna Rajadhyaksha,
M.D. (Ex. 94), and additional medical literature (Ex. 95). (ECF No. 96.) Thereafter, on April 3,
2015, Petitioners filed the expert report and curriculum vitae of Dr. Brett Abrahams, Ph.D. (Exs.
96-97, ECF No. 97.)
6 In filing Exhibit 94, Petitioners’ counsel inadvertently marked that exhibit as an “Expert
Report,” instead of properly marking that exhibit as “medical records.” (Ex. 94, ECF No. 96.)
Exhibit 94 contains only C.A.P.’s medical records, including genetic test results from his
medical examination by Dr. Rajadhyaksha. (Id.)
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On June 8, 2015, this case was reassigned to my docket due to the impending retirement
of then-Chief Special Master Vowell. (ECF No. 103.) Thereafter, on December 1, 2015,
Petitioners filed the expert report of Jean-Ronel Corbier, M.D. (Ex. 98; ECF No. 112.)
Subsequently, on December 4, 2015, Petitioners filed the curriculum vitae and supplemental
expert report of Dr. Corbier. (Ex. 99; ECF No. 113.) On March 29, 2016, Respondent submitted
the supplemental expert report of Dr. Raymond (Ex. L), and the corresponding medical literature
cited in that report (Exs. M-S). (ECF No. 116.)
I held a telephonic status conference with both parties on April 7, 2016. (ECF No. 118.)
At that time, Petitioners’ counsel observed that the viability of the Petitioners’ expert reports was
predicated on the accuracy of parental reports describing symptoms not reflected in the
contemporaneous medical records. (Id.) Thus, Petitioners’ counsel proposed a “fact hearing” in
order to determine whether such family reports can be found credible in light of the
contemporaneous medical records. (Id.) On June 13, 2016, Petitioners’ counsel filed a status
report informing the Court that four witnesses would testify at the “fact hearing” -- Ellena
Prokopeas; Chris Prokopeas; Nick Chrissikos; and Naomi de la Torre. (ECF No. 124.)
Concurrently, Petitioners submitted the statement of Nick Chrissikos (Ex. 100); Amendment to
Ellena Prokopeas’ Affidavit (Ex. 101); and the statement of Naomi de la Torre (Ex. 102).7 (ECF
No. 125.)
I conducted the requested “fact hearing” in Washington, D.C. on August 1, 2016. At that
time, only Ellena Prokopeas testified for the Petitioners. (ECF No. 130; Tr. 4-5.) This matter is
now ripe for a ruling on the disputed facts.
IV
FACTS
A. Medical history appearing in C.A.P.’s medical records
1. C.A.P.’s first month of life
C.A.P. was born on December 6, 2001. (Ex. 1, pp. 1-2.) During his first month of life,
C.A.P. was seen by Pediatric Associates of Dallas for routine childhood illnesses. (See Ex. 34-2
generally.) Specifically, on December 11, 2001, jaundice was noted (Ex. 34-2, p. 30); and on
December 27, 2001, he was treated for a fever, congestion, runny nose, and decreased appetite
(id., pp. 31-32). However, at both his two-week well visit of December 20, 2001, and his one-
month well-visit of January 8, 2002, C.A.P. was recorded as being a “well” baby. (Id., pp. 32-
33.)
7 Petitioners filed a status report on June 24, 2016, indicating that they did not intend to file
an additional affidavit for Chris Prokopeas, choosing, instead, to rely on the signed joint
statement of Chris and Ellena Prokopeas (filed as Exhibit 58), to be the entirety of Mr.
Prokopeas’ testimony in this case. (ECF No. 127.)
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2. C.A.P.’s first set of vaccinations and following care
C.A.P. had his two-month well-visit on February 5, 2002. (Ex. 34-2, p. 34.) At that time,
he presented with a “stuffy nose” and diarrhea, and was recorded to be sleeping three to four
hours per night. (Id.) He was described as a “well baby,” and was administered the following
vaccinations: DTaP, IPV, Comvax (combination dose of the Hib and hepatitis vaccines), and
Prevnar. (Id.)
3. C.A.P.’s second set of vaccinations and following care
C.A.P. was next seen by his pediatrician for his four-month well-visit on April 9, 2002.
(Ex. 34-2, p. 35.) No reaction to the vaccinations of February 5, 2002, was recorded. (Id.) At
that time, he was recorded to be sleeping up to five hours a night, was assessed as a “well baby,”
and was administered the DTaP, IPV, Hib, and Prevnar vaccinations. (Id.) C.A.P. saw his
examining physician again on April 30, 2002,8 presenting with a cough, runny nose, and a rash
throughout his body -- symptoms that were reported to have persisted for one week. (Id.) At that
visit, he was reported, among other things, to be “happy,” and was diagnosed with having an
upper respiratory infection (“URI”). (Id.)
4. C.A.P.’s third set of vaccinations and following care
C.A.P. had his seven-month well-visit on July 22, 2002. (Ex. 34-2, p. 36.) C.A.P.’s
pediatrician recorded that he was sleeping approximately four hours per night, and was assessed
as a “well child” overall, receiving the DTaP, Hib, Hep B, and Prevnar vaccinations at that visit.
(Id.)
On July 23, 2002, C.A.P.’s medical records include a notation of a phone call from Mr.
Prokopeas, relaying that C.A.P. had a fever of 102-103 degrees Fahrenheit. (Ex. 34-2, p. 36.)
Mr. Prokopeas described C.A.P. as being “fussy,” but reported that he was feeling better with
Motrin, and was “eating ok.” (Id.) However, Mr. Prokopeas reported that both parents were
concerned because C.A.P.’s fever had not come down. (Id.) That medical record further reveals
that a staff member from C.A.P.’s pediatrician’s office documented discussing a variety of topics
concerning fevers with C.A.P.’s parents, including fever control, and fever as a reaction to
immunizations. (Id.) Specifically, that staff member documented advising the parents that fevers
as a reaction to immunizations can last up to 24 to 36 hours post-immunizations, and
documented advising them to call back the next day (i.e., on July 24, 2002), if C.A.P. still had a
fever the next morning, or if any new symptoms developed during that time period. (Id.)
8 This medical record from April of 2002 (Ex. 34-2, p. 35) is unclear at first glance as to
the precise date. At the fact hearing, Mrs. Prokopeas testified that she believed that C.A.P.’s
visit was most likely on April 13, 2002. (Tr. 17-18.) As discussed at Section VII(A)(2) below,
however, I do not accept Mrs. Prokopeas’ interpretation of C.A.P.’s sick visit to be on April 13,
2002. Instead, I find that that medical visit was on April 30, 2002.
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C.A.P.’s medical records also reflect a notation9 of a second phone call at a later time on July 23,
2002, by Mrs. Prokopeas. (Id., p. 37.) That phone call notation reflects Mrs. Prokopeas reporting
that C.A.P. had a temperature of 102-103 degrees Fahrenheit; however, she also reported C.A.P.
as being “playful,” and having no additional symptoms other than his fever. (Id.)
On July 24, 2002, C.A.P. was taken back to his pediatrician, and his fever symptoms
were reported to have continued for the past two days. (Ex. 34, p. 37.) That medical record
reflects C.A.P.’s parents describing C.A.P. as “not himself,” and reporting his temperature to be
as high as 103 degrees Fahrenheit. (Id.) C.A.P.’s temperature was taken during that examination
visit, and was recorded to be 101.4 degrees Fahrenheit. (Id.) Moreover, C.A.P. was reported to
be taking “Tylenol/Motrin” to control his fever. 10 (Id.)
On July 25, 2002, Mrs. Prokopeas took C.A.P. to see another pediatrician, Dr. Porter.
(Ex. 10, p. 4.) During that visit, Dr. Porter recorded Mrs. Prokopeas’ accounts of C.A.P.’s
ongoing symptomatology, noting that C.A.P. was experiencing a fever for four days (“F x 4”),
with his highest temperature reaching 103.9 degrees Fahrenheit. (Id.) Mrs. Prokopeas also
reported that C.A.P. had vomited three times (“V x 3 times”), had diarrhea twice (“D x 2 times”)
since the previous day, was fussy, and could not “keep anything down.” (Id.) However, on the
day of the visit, C.A.P. was reported to have been successfully breast-fed three times that day,
with no further diarrhea, and observed by Dr. Porter to be “happy” and “playful.” (Id.) Dr.
Porter diagnosed C.A.P. with “viral gastroenteritis,” recommending that C.A.P. stay “well
hydrated,” and asked Mrs. Prokopeas to call back if C.A.P. exhibited increased listlessness,
increased vomiting, or if his fever persisted for more than 48 hours. (Id.)
Thereafter, C.A.P.’s medical records reflect that Mrs. Prokopeas contacted C.A.P.’s
pediatrician’s office on August 13, 2002. (Ex. 10, p. 4.) That notation reflects a phone call from
Mrs. Prokopeas, relaying her worries that C.A.P. had diarrhea again for the past week (“D again
x 1 wk”), had no appetite (“no app.”), was not nursing well, had some dry diapers, and wanted
C.A.P. to be seen by the pediatrician. (Id.) C.A.P. was seen by Dr. Porter on August 14, 2002, at
which time Mrs. Prokopeas reported that C.A.P. was not sleeping well, was fussy, had a cough
for the past three days (“C x 3 days”), had diarrhea for 7 days (“D x 7 days”), and spat up yellow
mucus. (Id.) C.A.P.’s pediatrician diagnosed him with oral thrush (“thrush”), and “feeding
issues.” (Id.) He was prescribed Gentian Violet (a common medication to treat oral thrush), and
the pediatrician encouraged his parents to feed him solids, and asked to be updated by the parents
if C.A.P.’s symptoms persisted. (Id.)
9 Mrs. Prokopeas testified at the fact hearing that the second phone call of July 23, 2002,
was initiated by C.A.P.’s pediatrician, who was calling her back to check on C.A.P.’s condition.
(Tr. 22.)
10 This medical record of C.A.P.’s sick visit of July 24, 2002, is partly illegible. (Ex. 34-2,
p. 37.) One of the notations on that medical note may possibly read “? Rx to shot” (that is,
“reaction” to shot). (Id.)
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5. C.A.P.’s vaccination on September 24, 2002, and following care.
C.A.P. had his nine-month well-visit on September 24, 2002. (Ex. 10, p. 3.) That medical
record, among other things, reflects that C.A.P. “crawls,” and “stands with assistance.” (Id.) He
was assessed as being a “well” nine-month old, and was administered his third dose of the
Hepatitis B vaccine. (Id.)
Mrs. Prokopeas took C.A.P. to his pediatrician on September 30, 2002, reporting, among
other things, that C.A.P. had congestion, and a runny nose (“RN”) for the past three days (“x 3
day”). (Ex. 10, p. 3.) Moreover, Mrs. Prokopeas reported that C.A.P. was sneezing, had vomited
once a day for seven days, was teething, and was not sleeping well. (Id.) Dr. Porter recorded that
C.A.P. was alert and cooperative during the medical examination, and diagnosed him as
suffering from a viral upper respiratory infection (“URI/Viral”), vomiting phlegm (“Vom
phlegm”), and having feeding problems. (Id.)
On October 13, 2002, C.A.P. was seen in the Emergency Department of the Medical City
of Dallas Hospital, for complaints of vomiting and diarrhea that had started on the same day.
(Ex. 35, pp. 16-19.) Upon examination, C.A.P. was diagnosed with having “[g]astroenteritis.”
(Id., p. 19.)
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6. C.A.P.’s medical care from November of 2002 to August of 2003. 11
In an affidavit of December 1, 2014, Mrs. Prokopeas reported that “there are no medical
records for C.A.P. from 11 months old to 20 months old” (covering the time period from
November of 2002 to August of 2003), stating that she did not take C.A.P. to a physician during
that time period, as she could not find a pediatrician amenable to postponing C.A.P.’s future
vaccinations. (Ex. 91, p. 1.) However, in her affidavit of June 13, 2016, Mrs. Prokopeas
indicated that “Dr. Kotsanis,” a family friend, provided some care when C.A.P. was 12 months
of age until he was 20 months of age. (Ex. 101, p. 1, ¶ 4.) In any event, Petitioners have not
submitted records of any medical care received by C.A.P. between October 13, 2002, and
October 23, 2003. (See generally Exs. 10 and 34.)
7. C.A.P.’s playground head injury and following care.
C.A.P.’s medical records reflect that he was examined by Dr. Kotsanis12 on October 23,
2003, for a head injury. (Ex. 67, p. 3.) At that time, Dr. Kotsanis recorded a medical history of
11 C.A.P.’s vaccination administration record from Dr. Porter (Ex. 10, p. 1) reflects a
stamped date of December 10, 2002 (“Dec 10 2002”), with a notation of “n/s” next to the rows
entitled “MMR1”; “Varivax”; and “Prevnar.” (Ex. 10, p. 1.) The exact meaning of the notation
of “n/s” is not clear in that record; however, that notation could possibly mean “no show.”
(Medical Abbreviations: 32,000 Conveniences at the Expense of Communication and Safety, 15th
ed., p. 232.)
In closely examining Ex. 10, p. 1, I note the contrast between C.A.P.’s documented
vaccination of September 24, 2002, versus the stamped notation of December 10, 2002. (Ex. 10,
p. 1.) In this regard, I point out that, on the column entitled “Signature of Parent or Guardian,”
that record reflects Mrs. Prokopeas’ signature by the corresponding row, documenting C.A.P.’s
administered Hep B vaccination of September 24, 2002. (Id.) In contrast, there is no such
corresponding signature by the date stamps of December 10, 2002, by the “MMR1,” “Varivax,”
and “Prevnar” columns. (Id.) Moreover, I note that while there is documentation by Dr. Porter of
C.A.P.’s office visit of September 24, 2002 (Ex. 10, p. 3), no such documentation exists for any
such visit from December 10, 2002 (see generally Ex. 10). Thus, it seems unclear whether
C.A.P. was administered any vaccinations on December 10, 2002.
Regardless of the precise significance of the “n/s” notation, I note that none of
Petitioners’ pleadings (ECF Nos. 1, 51, 57), affidavits (Exs. 58, 91, 100-102), or expert reports
(Exs. 87, 89, 96, 98-99) submitted in this case allege that C.A.P.’s present condition is due to any
potential vaccinations received by C.A.P. on December 10, 2002.
12 I note that the extent to which Dr. Kotsanis was a treating physician of C.A.P. is unclear
in this case. Several of C.A.P.’s medical records submitted in this case reflect Dr. Kotsanis
serving as a non-primary care provider to C.A.P. (E.g., Exs. 5, 25, and 48 generally.) Moreover,
in one of those medical records, Dr. Kotsanis himself stated that his role in C.A.P.’s treatment
was limited to that of “being supportive for convenience reasons.” (Ex. 48, p. 2.) However, in
her affidavit of June 13, 2016, Mrs. Prokopeas referenced Dr. Kotsanis as being C.A.P.’s sole
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C.A.P., as reported by Mrs. Prokopeas. (Id.) That note indicates that, on September 20, 2003,13
C.A.P. suffered a head injury in a fall and was taken to the emergency room to be further
evaluated.14 (Id.) C.A.P. had a “very large” head hematoma (swelling due to collection of blood
in the blood vessels), and underwent a CT scan, among other additional testing, during that
emergency room visit. (Id.) Mrs. Prokopeas reported that those test results from C.A.P.’s
emergency room visit “appeared to be normal.”15 (Id.)
Furthermore, Mrs. Prokopeas relayed that, after C.A.P.’s head injury accident, he was “a
bit unsteady,” and that he had “decreased in verbalization.” (Ex. 67, p. 3.) Dr. Kotsanis recorded
in the oral history section that, besides the playground head injury, “other active problems at this
time are none.” (Id.) Upon examination at that time, Dr. Kotsanis recorded that the “area of the
trauma has healed very nicely,” but that C.A.P. appeared to “drift slightly to the right side,” and
that he was “irritable.” (Id.) Overall, Dr. Kotsanis diagnosed C.A.P. with “post-concussion
syndrome,” referring him for hearing and speech evaluations. (Id.)
medical care provider when C.A.P. was 12 months of age until he was 20 months of age,
alleging as follows:
From 12-20 months old, [C.A.P.] was cared for by his mother and a family doctor friend,
Dr. Kotsanis. Before moving to New Orleans, Dr. Kotsanis ran a variety of lab test [sic]
on [C.A.P.] as indicated in his medical records.
(Ex. 101, p. 1, ¶ 4.)
13 This medical record is not completely clear as to the exact date of C.A.P.’s head injury.
(Ex. 67, p. 3.) The type-written date of C.A.P.’s head injury appears to be on “10/20/2003.” (Id.)
However, there is a hand-written “9” transposed on top of the “10,” seeming to reflect Dr.
Kotsanis’ hand-written correction that C.A.P.’s head injury occurred a month prior, on
“9/20/2003.” (Id.) Thus, based on a close examination of that record, and the surrounding
context, it appears that C.A.P.’s playground injury likely occurred in September of 2003.
However, I am also mindful that C.A.P.’s medical records reflect alternating references to
C.A.P.’s head injury in either September or October of 2003. (See Ex. 54-2, pp. 43-44; Ex. 16, p.
1.)
14 Petitioners did not submit C.A.P.’s medical records from the emergency room visit of
September or October of 2003 seeking treatment for C.A.P.’s head injury. As a result, the record
of this case contains only secondary medical records describing C.A.P.’s head injury of
September or October of 2003. Thus, all the medical records which reflect C.A.P.’s head injury
of September or October of 2003, reflect parental descriptions of C.A.P.’s playground accident
during which C.A.P. injured his head, as relayed to subsequent medical care providers while
seeking treatment for C.A.P.’s developmental issues. (See Ex. 67, p. 3; Ex. 54-1, p. 3; Ex. 54-1,
p. 4; Ex. 54-2, pp. 43-44; and Ex. 16, p. 1.)
15 Petitioners have not submitted C.A.P.’s emergency room diagnostic testing results to the
record in this case.
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8. C.A.P.’s medical care subsequent to October of 2003
a. C.A.P.’s care from November of 2003 to January of 2004
A referral form dated November 17, 2003, from Early Childhood Intervention of
Richardson/North Dallas (hereafter “ECI”), indicates that C.A.P. was referred to that practice to
be evaluated for speech delay. (Ex. 54-1, p. 3.) Under the “Additional Information” section of
that referral form, the following information was stated:
Child was hit by an iron gate and was hit in the fore head. Child had a big bump. The
accident happen [sic] in September. Child is not speaking like he use [sic] to speak
before the accident.
(Ex. 54-1, p. 3.)
On November 20, 2003, C.A.P. underwent an evaluation by ECI. (Ex. 54-1, p. 4.) The
intake form of that evaluation, which appears to be filled out by Mrs. Prokopeas, reflects that she
was “most concerned” about C.A.P.’s “speech delay and temper tantrums.” (Id.) The medical
care provider examining C.A.P. at that time also recorded an oral history, as given by Mrs.
Prokopeas, describing the circumstances of C.A.P.’s head injury in September of 2003. (Id.)
That medical evaluation note recorded that C.A.P. was “hit by an iron gate” while at Disneyland,
and that he was “not talking much at all” after his accident. (Id.) Moreover, that medical note
records Mrs. Prokopeas as saying that prior to C.A.P.’s head injury accident in September of
2003, C.A.P. “only had about 10 words”; however, by the time of his evaluation as of November
20, 2003, he was unable to speak any words, and was using “a lot of gestures.” (Id.)
On December 5, 2003, C.A.P. was once again evaluated by ECI. (Ex. 54-1, pp. 29-31.)
During that evaluation (when C.A.P. was approximately two years of age), several of his
developmental parameters were listed as being “of concern.” (Id., pp. 29-30.) Specifically, his
social-emotional development was listed to be within the 18-month age range; his
communication development was listed to be at 15-months of age; his expressive development
was listed as being in the 15-month age range; his cognition was listed to be within the 18-month
age range; and his fine-motor development was listed to be within the 15.5 month age range.
(Id.) Also, C.A.P.’s gross-motor development (within the 21-month age range) and self-help
skills (within the 24-month age range) were noted to be “WNL” (within normal limits). (Id., p.
31.)
On December 11, 2003, C.A.P. underwent an evaluation by ECI of Richardson’s
Individual Family Service Plan (“ECI IFSP”). (Ex. 54-2, pp. 43-51.) The “Integrated Summary”
section of that evaluation reflects an accounting given by Mrs. Prokopeas concerning C.A.P.’s
medical history, relaying that he “had no significant medical problems” until his head injury
accident at Disney land in October of 2003.16 (Id., pp. 43-44.) At that time, Mrs. Prokopeas
16 The “Integrated Summary” section of this medical record summarizes that:
[W]hen [C.A.P.] was in Disney Land in October he was accidentally hit with a hard iron
gate/door. His mother is unsure if he was knocked unconscious. She did not see it
happen. She heard him crying and was told what had happened. It is unknown how hard
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relayed her concerns that C.A.P.’s skills appeared to have regressed since the head injury
accident, observing C.A.P. to be “speaking more before the accident,” whereas after his accident
C.A.P. was using “gestures or screaming cries to get his needs met.” (Id., pp. 43-44.) That
medical note also reflects that C.A.P.’s parents were “researching other areas,” such as an
“autism spectrum” disorder, for C.A.P.’s apparent regression. (Id., p. 44.)
From December of 2003 to August of 2004, C.A.P. continued to receive regular
development therapy by ECI IFSP. (Exs. 54-1 through 54-4.)
b. C.A.P.’s medical history reflected in certain of Dr. Kotsanis’ treatment notes
An undated medical record from Dr. Kotsanis reveals the following medical history of
C.A.P.:
In October 2003 the child came to my office for the first time because of a head injury
while at Disney World. The CT [at] the ER in Florida was normal. The trauma did not
change anything.
(Ex. 5, p. 1.) Additionally, Dr. Kotsanis recorded the following relevant medical history:
The postvaccination injury that is reported by the parents goes along with my knowledge
about [C.A.P.] socially from our Church gatherings and eventually as a doctor in my
office. I remember that [C.A.P.] was initially a normal healthy child and eventually
matched the traits of autistic spectrum disorder children that visit my office.
(Ex. 5, p. 1.) Moreover, his impression was that C.A.P. had an “Autistic Spectrum Disorder
most likely secondary to vaccination injury.” (Id.)
On January 6, 2004, Mr. and Mrs. Prokopeas had a telephonic consultation with Dr.
Kotsanis. (Ex. 5, pp. 2-4.) Dr. Kotsanis’ recorded notes from that phone consultation reveals that
C.A.P.’s parents believed that he suffered a “vaccination injury.” (Id., p. 2.) At that time,
C.A.P.’s parents also reported that he suffered from allergies and behavior problems that were
“out of control.” (Id., p. 2.)
Moreover, Dr. Kotsanis’ medical notes from the phone consultation of January 6, 2004,
state that he “conducted an extended history” of C.A.P.’s “progress and problems since birth.”
(Ex. 5, p. 2.) In this regard, Dr. Kotsanis recorded an oral medical history, as given by C.A.P.’s
parents, concerning C.A.P.’s early years of life. (Id.) At that time, C.A.P.’s parents reported that
he had “met all” of his developmental milestones until July of 2002, but that they started noticing
problems after his vaccinations administered later that month. (Id., pp. 2-3.) They further
described C.A.P.’s condition after his vaccinations of July 22, 2002, stating that C.A.P. had
“diarrhea for two consecutive weeks after the vaccinations,” in addition to having a “persistent
his head was hit, but family took him to hospital immediately following. Cat scan showed
nothing.
(Ex. 54-2, pp. 43-44.) (Compare Ex. 67, p. 3, reflecting that C.A.P.’s head injury accident
possibly occurred in September of 2003.)
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dry cough,” a fever, refusing to breast feed, difficulties sleeping, and being in constant motion
when awake. (Id., p. 3.) They additionally reported that “as time went on,” C.A.P. exhibited
additional symptoms, such as: “head banging;” “uncontrollable crying for no reason;” “increased
hyperactivity;” displaying a “fear of being alone;” having worsening sleeping patterns; and being
“nonverbal.” (Id.)
Furthermore, in his phone consultation note of January 6, 2004, Dr. Kotsanis also
recorded that “[i]n the summer/fall of 2002,” C.A.P.’s parents attended one of Dr. Kotsanis’
“public lectures,” during which he advised them to “do a comprehensive pediatric evaluation
with a pediatrician that is aware of possible postvaccination injury,” thus reinforcing the parents’
decision to “withhold vaccinations.” (Ex. 5, p. 3.) Overall, Dr. Kotsanis recommended that
C.A.P. be seen by a new pediatrician, Dr. Hamel, but noted that he would continue to monitor
C.A.P.’s condition by phone until C.A.P. found “proper care.” (Id., p. 4.)
c. C.A.P.’s continuing care from February of 2004
On February 9, 2004, C.A.P. underwent an audiological evaluation during which his
treating audiologist recorded Mrs. Prokopeas’ concerns about C.A.P.’s condition. (Ex. 16, p. 1.)
Mrs. Prokopeas reported that C.A.P. was “not talking as well as his peers,” was “having periods
when he is not verbal,” and was having “problems with behavior.” (Id.) Moreover, Mrs.
Prokopeas stated that her concerns “began in October 2003, when [C.A.P.] had an injury to his
forehead.” (Id.) Upon examination, the treating audiologist diagnosed C.A.P. with having
“abnormal auditory signs and symptoms.” (Id.)
C.A.P.’s medical records additionally reflect that, on June 23, 2004, Mrs. Prokopeas
filled out a “Review Of Systems By Symptoms” intake history form in preparation to be seen by
Charles Hamel, M.D. (Ex. 18, pp. 3-6 of 14.) Within the “Patient History Questionnaire” section
of that intake form, Mrs. Prokopeas described the purpose of her visit with Dr. Hamel to be to
“[h]elp my son recover from PDD (pervasive development delay) which is part of the ‘autism
spectrum disorder.’”17 (Id., p. 6.)
On June 25, 2004, C.A.P. went to the emergency room to be evaluated for head
lacerations sustained when he fell in his bathtub. (Ex. 17, p. 10.) Thereafter, on July 19, 2004,
C.A.P. was seen by Dr. Hamel. (Ex. 18, p. 7.) During that visit, Dr. Hamel’s impression was that
C.A.P., among other things, had autism, a possible pervasive developmental disorder (“? PDD”),
and food allergies. (Id.)
On July 22, 2004, C.A.P. was seen by Gordon Bourland, Ph.D., for an evaluation of an
autism spectrum disorder (ASD) diagnosis. (Ex. 9, p. 1.) At that time, Dr. Bourland took a
history of C.A.P.’s symptoms, and recorded Mrs. Prokopeas’ recollections of C.A.P.’s
17 Mrs. Prokopeas also listed that C.A.P. had magnetic resonance imaging (MRI) testing
done on “9-20-03.” (Ex. 18, p. 6.) The context indicates that Mrs. Prokopeas was possibly
referring to the MRI testing conducted at the time of C.A.P.’s head injury accident during
September or October of 2003. (Compare Ex. 67, p. 3; and Ex. 54-1, p. 3.)
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developmental history. Specifically, Dr. Bourland recorded the following oral history, as
reported by Mrs. Prokopeas:
This past November [of 2003] [C.A.P.]’s parents noted a substantial change in his
behavior. He began fussing and crying much more than previously had been the case, his
eye contact, reported as previously typical became briefer and less consistent, he
responded less consistently to people speaking to him, and his attention span shortened
considerably, as well as he became more insistent upon things and activities being as he
preferred.
(Ex. 9, p. 1.) Dr. Bourland diagnosed C.A.P. with Pervasive Developmental Disorder-Not
Otherwise Specified (PDD-NOS), a form of autism. (Id., p. 4.) Also on July 22, 2004, Mrs.
Prokopeas had a phone consultation with Dr. Kotsanis, who noted that Mrs. Prokopeas “had a lot
of questions on chelation and vaccination injury,” but that he addressed both of her concerns in
detail, and that C.A.P. was “scheduled to start chelation with Dr. Hamel.” (Ex. 5, p. 5.) In his
notes from the phone consultation of July 22, 2004, Dr. Kotsanis recorded that C.A.P. had an
“autistic spectrum disorder by history from my office,” which he classified as being secondary to
“vaccination trauma syndrome.” (Id.)
On October 11, 2004, C.A.P. underwent a psychological evaluation by William Brasted,
Ph.D. (Ex. 69.) In relevant part, Dr. Brasted recorded the following accounting of C.A.P.’s
developmental history, as given to him by Mr. Prokopeas:18
At 9-12 months, the family noticed that [C.A.P.] was not achieving developmental
milestones within normal limits. He (sic) speech appeared delayed. At 9 months of age,
[C.A.P.] appeared to have a reaction to his immunization shots. He began having temper
tantrums and banging his head at 12 to 14 months of age and was easily irritated.
(Ex. 69, p. 4.) During that visit, C.A.P. was classified as functioning in the “Mild Range of
Mental Retardation with regard to both intellectual abilities and the performance of adaptive
skills.” (Id., p. 5.)
A letter dated March of 2005, from Carmela Tardo, M.D., reflects that she evaluated
C.A.P. for autism on November 8, 2004. (Ex. 75, p. 2.) In that letter, Dr. Tardo stated that
during her consultation with C.A.P. on November 8, 2004, she had “no records available for
review”. (Id.) As such, at that time, Dr. Tardo recorded an oral history of C.A.P.’s condition, as
reported to her by Mrs. Prokopeas. (Id.) Mrs. Prokopeas stated that she became concerned about
C.A.P.’s development “when he was approximately 20 months of age,” initially thinking that
C.A.P. was “just a late talker,” but subsequently became concerned about his socialization. (Id.)
Mrs. Prokopeas additionally relayed to Dr. Tardo that C.A.P. walked at 14 months of age, and
that at around one year of age, C.A.P. had approximately ten words in his expressive vocabulary,
but that his speech had subsequently regressed since that time. (Id.)
18 That medical record lists “Chris Prokopeas (father)” as the “Informant” on that evaluation
report. (Ex. 69, p. 2.) Additionally, that record states that C.A.P. “was accompanied to the
current testing session by his father, Chris Prokopeas.” (Id., p. 4.)
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In her letter from March of 2005, Dr. Tardo further stated that during C.A.P.’s
consultation visit of November 8, 2004, she could not conclusively diagnose C.A.P. with autism
due to her limited examination of C.A.P. at that time; however, she believed that an autism
diagnosis “would be a strong possibility” in explaining his condition. (Ex. 75, p. 2.)
From May to September of 2005, C.A.P. continued to receive developmental therapy
from the Central Texas Autism Center (“Autism Center”). (See Exs. 19 and 49.) An evaluation
note generated from one of C.A.P.’s visits to the Autism Center reflects C.A.P.’s parents
reporting that C.A.P. was diagnosed with autism on November 8, 2004.19 (Ex. 19, pp. 4, 12.)
Additionally, a letter dated July 26, 2005, from Anju Usman, M.D., documents C.A.P.’s
consultation visits under her care. (Ex. 23.) In relevant part, Dr. Usman’s records state the
following treatment history:
[C.A.P.] was originally seen on 12/13/04. His mother reported a history of aggressive
outbursts *** and headbanging. He was also diagnosed with toxic encephalopathy.
(Ex. 23, p. 2.)
On May 4, 2007, C.A.P. was examined by Mark Geier, M.D., who conducted a
neurodevelopmental disorder assessment of C.A.P. (Ex. 25-2, pp. 43-53.) As part of that
evaluation, Mrs. Prokopeas filled out a form in which she relayed C.A.P.’s developmental
history. In the “developmental history” section of that form, Mrs. Prokopeas20 reported that
C.A.P. regressed at “19-20 months,” with “loss of language,” “behavioral problems,” “hand
flapping/head banging,” and “stereotypic behaviors.” (Id., p. 48.)
In a letter dated April 9, 2010, Dr. Kotsanis stated that he had “seen [C.A.P.] as a patient
on and off since 2002-2003,” and that his “working diagnosis was ‘autistic spectrum disorder.’”
(Ex. 48, p. 2.) 21 Furthermore, Dr. Kotsanis stated as follows:
My role in [C.A.P.]’s treatment had only being (sic) supportive for convenience reasons.
I was never his primary care physician. Over the years I have ordered a few tests and
written a few prescriptions as per parent’s request and Dr. Edelson’s recommendation.
19 As noted immediately above, however, Dr. Tardo’s letter from March of 2005 reveals
that she had not diagnosed C.A.P. with an autism spectrum disorder on November 8, 2004, but
was simply of the belief that an autism diagnosis “would be a strong possibility.” (See Ex. 75, p.
2.)
20 That medical record reflects that the “Autism Treatment Evaluation Checklist” (ATEC)
was completed by “Ellena Prokopeas.” (Ex. 25-2, p. 43.)
21 That letter from Dr. Kotsanis additionally stated that to the best of his knowledge,
C.A.P.’s parents had decided over time to “seek medical advice and treatment by Stephen B.
Edelson MD in Atlanta, Georgia.” (Ex. 48, p. 2.)
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(Ex. 48, p. 2) Additionally, Dr. Kotsanis remarked that he could not find medical records of
C.A.P.’s treatment under his care from 2002 to 2003; however, he stated that to the best of his
recollection, C.A.P. had an “autistic spectrum disorder.” (Id.)
9. C.A.P.’s genetic testing
Starting in May of 2007, C.A.P. also underwent genetic testing. (Ex. 25, p. 8.) However,
the existence of these genetic testing results is not disputed by the parties, and thus is not relevant
in resolving the disputed facts in this case. Thus, I will not discuss his genetic testing results
further in this ruling.
B. Additional medical history reported by C.A.P.’s parents and family friends
In this section, I list additional allegations, made by C.A.P.’s parents and family friends,
which are at variance with his medical records concerning two key issues: (1) C.A.P.’s
symptomatology following each set of vaccinations administered to him in his first year of life;
and (2) C.A.P.’s alleged neuro-developmental medical history from his early months of life -- a
medical history which, according to his parents, is not properly documented in his medical
records.
1. Ellena Prokopeas
Mrs. Prokopeas submitted affidavits on March 12, 2012 (Ex. 58), December 1, 2014 (Ex.
91), and June 13, 2016 (Ex. 101). She also testified at the “fact hearing” held on August 1, 2016.
(Tr. 4-41.) Her first affidavit (Ex. 58) was a joint affidavit with her husband, Chris Prokopeas.
(Ex. 58, p. 4.) 22 However, only Mrs. Prokopeas, and not her husband, testified at the “fact
hearing.” Accordingly, while in this section of this Ruling, for convenience’s sake, I summarize
the affidavits and testimony of Ellena Prokopeas, I am well aware that Ex. 58 contains the joint
representations of both Ellena and Chris Prokopeas.
a. C.A.P.’s alleged symptoms following his first set of vaccinations.
Mrs. Prokopeas testified that “within a few minutes” of C.A.P.’s first set of vaccinations
of February 5, 2002, he began to scream and cry uncontrollably, followed by a “deep sleep for
many hours.” (Ex. 58, p. 1; Tr. 11-14.) She alleged that even after C.A.P. woke up, he was “red
and swollen” at the place of the vaccination site; was screaming, crying, and being very fussy;
rejected nursing, had lost his appetite, appeared “very weak,” and ran a high fever of 103.9
degrees Fahrenheit overnight. (Tr. 14-15.) Mrs. Prokopeas added that she called C.A.P.’s
pediatrician the next morning (i.e., on February 6, 2002), and was told that a fever due to his
vaccinations could last up to 24 to 48 hours. (Tr. 15.) She testified that C.A.P.’s fever did go
down within 24 to 48 hours, and that “some” of his additional symptoms had also decreased
during that timeframe. (Id.) Additionally, in her affidavit of March 12, 2012, Mrs. Prokopeas
alleged that C.A.P.’s “injection site was swollen and red on both legs for days,” and that he
rejected nursing for five days following his vaccinations of February 5, 2002. (Ex. 58, p. 1, ¶ 4.)
22 Although that exhibit was filed on March 12, 2012, it appears that Mr. and Mrs.
Prokopeas signed and dated that affidavit on October 21, 2004. (Ex. 58, p. 4.)
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b. C.A.P.’s alleged symptoms following his second set of vaccinations.
Mrs. Prokopeas asserted that after receiving his vaccinations of April 9, 2002, C.A.P.
experienced symptoms “very similar” to those that he had after his first set of vaccinations (i.e.,
instant screaming, uncontrollable crying, rejecting nursing, falling into a deep sleep, having
“swelling and redness on both legs,” and developing a fever). (Tr. 16-17; Ex. 58, p. 1, ¶ 5.)
Moreover, she relayed that C.A.P. “developed a cough, runny nose, and a rash that lasted for a
week.” (Ex. 58, p. 1, ¶ 5.)23 In an affidavit, Mrs. Prokopeas averred that she called C.A.P.’s
pediatrician’s office after that incident, but was assured that C.A.P.’s symptoms were normal,
and that they would “pass within 48 hours.” (Ex. 58, p. 1, ¶ 5.)
At the fact hearing, Mrs. Prokopeas testified that, on April 13, 2002,24 she took C.A.P. to
the pediatrician, since he continued to suffer from the above-mentioned symptoms. (Tr. 17-19.)
She stated that at that visit, C.A.P. still had a rash throughout his body, was coughing, and had a
runny nose, but that his fever had resolved. (Id.)25
c. C.A.P.’s third set of vaccinations and alleged ensuing symptoms
Recounting C.A.P.’s symptomatology after his vaccinations of July 22, 2002, Mrs.
Prokopeas indicated by affidavit that his third set of vaccinations “seemed to do the most harm
so far.” (Ex. 58, p. 1, ¶ 6.) She stated that C.A.P. had “[v]ery much the same symptoms” as he
had after his first two rounds of vaccinations (i.e., instant screaming, uncontrollable crying,
rejecting nursing, falling into a deep sleep, having swelling and redness on both legs, and
developing a fever). (Tr. 20; Ex. 58, pp. 1-2.) She testified that C.A.P. had a fever of 103.9
degrees Fahrenheit on the night of July 22, 2002 -- a temperature that she alleged lasted “for
days.” (Ex. 58, pp. 1-2; Tr. 20-21.)
23 At the “fact hearing,” Mrs. Prokopeas, after consulting her written notes, eventually
stated that C.A.P. suffered those same symptoms that were listed in her affidavit filed on March
12, 2012, testifying as follows:
[L]ooking at my notes, in addition to that, I also noticed that he also started coughing –
well it didn’t happen right away, but later in the night, he started running – he had a
runny nose, he was coughing, and he had a rash throughout his body.
(Tr. 17.) As discussed further in Section VII(B)(1) below, throughout her fact hearing testimony,
Mrs. Prokopeas appeared to be reading from her notes to refresh her memory of certain events.
(E.g., Tr. 21-22; 29-30; 34.)
24 As noted above in footnote 8, Mrs. Prokopeas was referring to the trip to C.A.P.’s
pediatrician on April 30, 2002, which she believed occurred on April 13, 2002. (Tr. 17-19.)
25 As further discussed in Section VII(B)(1)(b) of this fact ruling below, I note that in
questioning Mrs. Prokopeas about C.A.P.’s visit to the pediatrician in April of 2002, Petitioners’
counsel asked several leading questions in an attempt to somehow relate C.A.P.’s condition to
his vaccinations of April 9, 2002. (Tr. 18-19.)
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Mrs. Prokopeas testified that she called C.A.P.’s pediatrician’s office on July 23, 2002,
and spoke with a nurse, reporting that C.A.P. had a fever, was miserable, could not open his
eyes, rejected nursing, seemed to be “very weak,” and “appeared lifeless.” (Tr. 21-22.)
Additionally, she recalled stating to the nurse that C.A.P.’s fever “had dropped slightly to 102 to
103” degrees, as he was taking Motrin and Tylenol to control his fever. (Id.)
She further testified that C.A.P.’s pediatrician called her back later that same day (i.e., on
July 23, 2002), and that she told the pediatrician that C.A.P. had the “same symptoms” as when
she spoke with the nurse earlier that day. (Tr. 22.) Notably, Mrs. Prokopeas testified that
C.A.P.’s pediatrician’s note of the phone call of July 23, 2002, stating that C.A.P. was “playful,”
and that he had “no other symptoms” beyond fever, was inaccurate. (Tr. 22; compare Ex. 34-2,
p. 37.) In this regard, she averred that C.A.P. was “very sick” at that time, and thus, would not
have been playful at the time of the pediatrician’s phone call. (Id.)
Mrs. Prokopeas also described taking C.A.P. to his pediatrician on July 24, 2002, because
she was “increasingly concerned” that he was “very fussy” all day, “was crying,” 26 and was not
being himself. (Tr. 23.) In her affidavit, Mrs. Prokopeas reported being told at that visit that
C.A.P.’s symptoms were not related to his recent vaccinations, and that those symptoms would
eventually pass. (Ex. 58, p. 2.)
Mrs. Prokopeas further asserted that on the night of July 24, 2002, C.A.P. “was getting
even worse,” and he had started vomiting. (Tr. 24.) Thus, on July 25, 2002, Mrs. Prokopeas
recalled taking C.A.P. to another pediatrician, Dr. Porter. (Tr. 24-28.) She testified that at that
time, C.A.P.’s symptoms from the previous two days had continued, and that he had additionally
developed diarrhea, and was vomiting. (Id.) She asserted that Dr. Porter’s assessment of C.A.P.
was that he was suffering from a “virus,” but she was assured that “everything would be fine.”
(Tr. 27; Ex. 58, pp. 1-2.)
At the fact hearing, Mrs. Prokopeas asserted that, after his visit with Dr. Porter on July
25, 2002, C.A.P. “seemed to have been getting better.” (Tr. 29-30.) She testified that starting on
July 26, 2002, C.A.P.’s symptoms were “slowly getting better,” but that he continued to have
diarrhea, vomiting, and a cough. (Tr. 28.) Additionally, she stated that he was “very fussy,” was
not sleeping, and did not nurse well for “a few days.” (Id.) Notably, however, in her affidavit of
March 12, 2012, Mrs. Prokopeas asserted that C.A.P.’s diarrhea symptoms were still ongoing
“even three weeks later” after his vaccinations of July 22, 2002. (Ex. 58, p. 2.)
Mrs. Prokopeas also testified about taking C.A.P. to his pediatrician on August 13, 2002,
as he had a cough due to a cold, was not nursing, was fussy, was screaming, was unhappy, and
was uncontrollable. (Tr. 29-30; Ex. 58, p. 2.) Mrs. Prokopeas recalled C.A.P.’s pediatrician
26 At that point in the fact hearing, Petitioners’ counsel stated that C.A.P.’s pediatrician’s
handwritten note from C.A.P.’s consultation of July 24, 2002, was partly illegible. (Tr. 23-24.)
Similarly, Petitioners’ counsel stated that the pediatrician’s notation about C.A.P.’s sick visit of
July 25, 2002, was also partly illegible. (Tr. 25.) For both of these medical records, Petitioners’
counsel suggested that he would get interpretations of those medical records prior to the fact
hearing transcript being published in this case. (Tr. 25-26.) As of the release of the fact hearing
transcript on August 1, 2016, however, Petitioners’ counsel did not submit any interpretations of
those medical notes, nor have any such interpretations have been submitted thereafter.
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prescribing an over-the-counter medication to treat his “thrush,” which subsequently cleared
“within a few days,” at which point C.A.P. started nursing again. (Id.)
In summary, in her affidavits, Mrs. Prokopeas alleged that after his third round of
vaccines, on July 22, 2002, C.A.P. experienced a variety of symptoms. (Ex. 58, p. 2.)
Collectively, these symptoms included: crying, being miserable, only sleeping two hours per
night, having intermittent “high fevers,” being difficult and demanding, having a “lack of eye
contact,” and developing random outbursts for no apparent reason. (Id.) At the fact hearing,
however, Mrs. Prokopeas recalled these symptoms as being less severe. (See Tr. 28-31.) In this
regard, she averred that once C.A.P.’s thrush resolved after his sick visit of August 13, 2002,
C.A.P. started nursing again, was not as fussy, was “sleeping a little better,” and that “[t]hings
looked like he was getting a little better.” (Tr. 31.)
d. C.A.P.’s vaccination of September 24, 2002, and alleged ensuing symptoms
Mrs. Prokopeas stated that after C.A.P.’s Hepatitis B vaccination of September 24, 2002,
C.A.P. experienced symptoms “almost identical” to those that he had experienced after his prior
rounds of vaccinations. (Tr. 32-33; Ex. 58, p. 2.) She alleged that immediately after that
vaccination, C.A.P. started crying, was screaming, was “very upset,” rejected nursing, was
unhappy, and slept for “many hours.” (Id.) She further testified that those symptoms continued
for a week, and she noticed him “getting worse,” prompting her to take C.A.P. to the pediatrician
on September 30, 2002. (Tr. 34; Ex. 58, p. 2.) Mrs. Prokopeas recalled reporting to the
pediatrician that C.A.P. was “just very, very sick,” additionally reporting the following
symptoms: “congestion”; “runny nose”; “coughing”; “not nursing”; “screaming”; wanting to be
held; and having diarrhea. (Tr. 34.) She additionally stated that at his sick visit of September 30,
2002, C.A.P.’s pediatrician assessed him with having a cold, and assured her that C.A.P.’s
symptoms would pass. (Ex. 58, p. 2.)
e. C.A.P.’s care from November of 2002
Mrs. Prokopeas stated that, due to C.A.P.’s alleged symptoms after his previously
administered vaccinations, she decided to postpone his future vaccinations. (Ex. 58, p. 2.)
Additionally, she stated that because of her decision not to administer further vaccinations to
C.A.P., Dr. Porter -- C.A.P.’s pediatrician at that time -- refused to provide further care. (Id.)
She acknowledged that there are “no medical records for C.A.P. from 11 months to 20 months of
age” (i.e., from November of 2002 to August of 2003) (Ex. 91, ¶ 3), although in a later statement
she indicated that a family friend, Dr. Kotsanis, provided some care to C.A.P. during this period
(Ex. 101, ¶ 4; see also Ex. 58, p. 2). In this regard, she further asserted that during that time
period, she “accepted [C.A.P.’s] behavior as being a difficult child,” but that she “never thought
we had a problem until he was 21 months old and still was not speaking.” (Ex. 58, p. 2)
f. C.A.P.’s alleged developmental progress from seven months of age to
twenty-four months of age
At the fact hearing, Mrs. Prokopeas provided a narrative of C.A.P.’s developmental
milestones from when he was seven months of age until he was twenty-four months of age. (Tr.
35-39.) Specifically, she referred to a chart in his medical records (entitled “developmental
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screening checklist”) -- a chart that was used by the Pediatric Associates of Dallas to track
C.A.P.’s development through the first seven months of his life. (Tr. 35-36; Ex. 34-1, pp. 15-17.)
27
At the fact hearing, Mrs. Prokopeas attempted to complete that developmental screening
chart, commenting on C.A.P.’s developmental milestones starting from when he was seven
months of age.28 (Tr. 36-39.) I list below, the “yes” or “no” answers given by Mrs. Prokopeas to
the age-appropriate questions from that developmental checklist chart.29
i. C.A.P.’s developmental parameters at seven months of age
Mrs. Prokopeas answered “yes” to both of the developmental checklist questions listed at
seven months of age: “lift hands when sitting,” and “transfers objects from 1 hand to other.” (Tr.
36; compare Ex. 34-1, p. 15.)
ii. C.A.P.’s developmental parameters at eight months of age
Mrs. Prokopeas answered “yes” to the question of whether C.A.P. “stays briefly on all
fours when placed.” (Tr. 37; compare Ex. 34-1, p. 16.) She answered “no” to the following
questions: “catches self to sides in sitting”; “sits at least five minutes”; and “rocks on all fours.”
(Id.)
iii. C.A.P.’s developmental parameters at nine months of age
Mrs. Prokopeas answered “yes” to the developmental parameter question of whether
C.A.P. “gets in and out of sitting independently.” (Tr. 37; compare Ex. 34-1, p. 16.) However,
she answered “no” to the following questions: “crawls on hands and knees”; “stands holding on
when placed”; “understands simple words”; “Shakes toys”; “Drops things and looks for them”;
“Says MaMa, DaDa.” (Id.)
iv. C.A.P.’s developmental parameters at ten and eleven months of age
For the chart’s developmental questions at ten months of age, she answered “no” to:
“pulls up to standing,” and “plays Peek-A-Boo.” (Tr. 37; compare Ex. 34-1, p. 16.) She also
answered a “no” to all of the following developmental questions listed at eleven months of age:
“cruises”; “walks holding on to the furniture”; “practices different standing positions while
27 Specifically, that checklist documented C.A.P.’s developmental progress at his various
medical visits to that pediatric practice. (Ex. 34-1, pp. 15-17.) Petitioners’ counsel asserted at the
fact hearing that C.A.P.’s developmental milestones chart was not updated after C.A.P. switched
to a different pediatrician at seven months of age. (Tr. 36.)
28 Mrs. Prokopeas attempted to complete the developmental checklist chart contained on
pages 15 through 17 of Exhibit 34-1. (Ex. 34-1, pp. 15-17.)
29 Petitioners’ counsel asked Mrs. Prokopeas to give “yes” or “no” answers to the listed
age-appropriate questions from the developmental checklist chart reflected on Exhibit 34-1,
pages 15 through 17. (Tr. 36-39.)
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holding on”; “lowers to sitting from standing”; “points/pokes with finger”; and “picks up small
objects with thumb and forefinger.” (Id.)
v. C.A.P.’s developmental parameters at twelve months of age
Mrs. Prokopeas answered “yes” to the following developmental parameter questions
concerning C.A.P. at twelve months of age: “waves bye-bye”; and “gives and takes toys in play.”
(Tr. 37; compare Ex. 34-1, p. 16.) She replied “no,” however, to the following developmental
checklist questions: “prefers standing to sitting”; “walks with 1 hand held”; “has 3-10 word
vocabulary”; “repeats performance if laughed at”; “puts things in containers”; and “drinks from
cup.” (Id.)
vi. C.A.P.’s developmental parameters at fifteen months of age
Mrs. Prokopeas answered “yes” to the checklist question of whether he “hugs and
kisses.” (Tr. 37; compare Ex. 34-1, p. 16.) She replied “no” to the following questions: “walks
independently”; “stands alone”; “indicates wants by gesturing/grunting”; and “builds tower of 3
blocks.” (Id.)
vii. C.A.P.’s developmental parameters at eighteen months of age
Mrs. Prokopeas answered “yes” for the following developmental parameters at eighteen
months of age: “climbs into chair”; “finger feeds”; and “points to 2-3 body parts.” (Tr. 38;
compare Ex. 34-1, p. 16.) She replied “no” to the following questions: “walks backwards”;
“takes clothes off”; “says 15-20 words”; “follows requests (i.e., get the ball)”; and “scribbles.”
(Id.)
viii. C.A.P.’s developmental parameters at twenty-four months of age
Mrs. Prokopeas answered “yes” to the following questions: “runs”; “carries toys
walking”; and “pulls toys.” (Tr. 37; compare Ex. 34-1, p. 16.) She replied “no,” however, to the
following questions: “squats”; “kicks a ball”; “rides bike-no pedals”; “walks up and down stands
holding rail”; “has 200 word vocabulary”; “uses 2 word sentences (i.e., ‘More Cookie’)”; “asks
questions (i.e., ‘Where’s kitty?, ‘What’s that’)”; “asks for food or drink”; “names some
pictures”; “builds tower of 6 blocks”; and “stays with one activity 6-7 minutes.” (Id.)
ix. C.A.P.’s developmental parameters at two and a half years of age
For his developmental checklist parameters at two and a half years of age, Mrs.
Prokopeas answered a “no” to all of the following questions: “jumps with 2 feet off ground”;
“knows full name”; “builds tower of 7+ blocks”; “point to body parts”; and “copies.” (Tr. 38;
compare Ex. 34-1, p. 17.)
2. Nick Chrissikos
Nick Chrissikos submitted an affidavit on June 13, 2016, but did not testify at the fact
hearing. (ECF No. 125, Ex. 100.) Mr. Chrissikos stated that he is a “very close family friend” of
the Petitioners, and, in this capacity, he was able to report on C.A.P.’s alleged symptomatology
after receiving each set of vaccinations in his first year of life. (Ex. 100, p. 1.)
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Mr. Chrissikos stated that, after receiving his first set of vaccinations on February 5,
2002, C.A.P. had diarrhea, and was “running a fever.” (Id.) Similarly, Mr. Chrissikos reported
seeing C.A.P. the day after he received his second set of vaccinations on April 9, 2002, alleging
that at that time, C.A.P. suffered from “a rash all over his body,” “a fever of over 101” degrees
Fahrenheit, being “fussy,” and crying excessively. (Id.)
Mr. Chrissikos also asserted that he observed C.A.P. soon after the vaccinations of July
22, 2002. (Ex. 100, p. 1.) He recalled that C.A.P. had developed a fever of 103 degrees
Fahrenheit, was “not nursing,” was “sleeping all day,” and was “screaming for no apparent
reason while appearing lifeless.” (Id.) He further alleged that these symptoms were “getting
worse” by July 25, 2002, and observed that these symptoms continued throughout August of
2002. (Ex. 100, p. 2.) Mr. Chrissikos also stated that in August of 2002 C.A.P. was “still sick,”
with a “high fever” and “vomiting” symptoms. (Id.) Notably, he claimed that C.A.P. had a “high
fever” as late as September of 2002. (Id.)
Moreover, Mr. Chrissikos stated that he observed C.A.P. after he was hospitalized in
October of 2002,30 alleging that he “looked tired,” would not smile, and would not come to him
when called. (Ex. 100, p. 2.) He also alleged that he observed C.A.P. on December 25, 2002,
crying for no apparent reason, and refusing to sit still. (Id., ¶ 5.)
Overall, Mr. Chrissikos alleged that “every time” he observed C.A.P., he was “fussy,”
“did not look well,” “always had dark circles under his eyes,” and “seemed to have a fever all the
time.” (Ex. 100, p. 2.) Similarly, Mr. Chrissikos stated that:
[l]ooking back, I can clearly see on the days he was vaccinated, within a few hours,
C.A.P. developed a high fever, screamed uncontrollably with a high pitch, and was
lethargic and irritable.
(Ex. 100, p. 3.)
3. Naomi de la Torre
Naomi de la Torre submitted an affidavit on June 13, 2016, but did not testify at the fact
hearing. (Ex. 102.) Ms. de la Torre alleged that she was “very close” to Mrs. Prokopeas, and
thus was able to observe C.A.P.’s condition from his early years of life. (Ex. 102, p. 1.)
Ms. de la Torre alleged that she observed C.A.P. on March 20, 2002 -- i.e., several weeks
after his first set of vaccinations of February 5, 2002. (Ex. 102, p. 1.) She described C.A.P. as
being “extremely sick” at that time, asserting that C.A.P. was fussy, had a runny nose, was
“running a fever,” and slept a majority of the day. (Id.) Similarly, she observed C.A.P. on July
23, 2002 (i.e., the day after his vaccinations of July 22, 2002), describing him as having a fever,
as being unable to sit still, and as crying uncontrollably. (Id.) Thereafter, Ms. de la Torre alleged
that she observed C.A.P. on July 25, 2002, describing C.A.P. at that time, as having “a rash all
over his body,” crying uncontrollably, being “very upset,” and “burning up with a fever of
30 Mr. Chrissikos was perhaps referring to C.A.P.’s emergency room visit of October 13,
2002. (Compare Ex. 35, pp. 16-19; see also pp. 14-15, above.)
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103.9” degrees Fahrenheit. (Ex. 102, p. 1.) She alleged that C.A.P.’s high fever at that time
lasted several days. (Id.)
Overall, Ms. de la Torre alleged that C.A.P. had ongoing symptoms of “rash,”
“irritability,” “crankiness,” “inconsolability,” and “fever,” stating that she observed these
symptoms “within a day of his vaccinations.” (Ex. 102, p. 2.) Moreover, she described C.A.P.’s
condition after his twelve-month well-visit, alleging that he “appeared to be getting worse,” since
he was not developing, not making eye contact, and perpetually fussy. (Id., ¶ 6.) She further
alleged that, over time, C.A.P. generally had “no expression on his face,” stopped laughing, and
stopped smiling. (Id., p. 3.)
V
SUMMARY OF PETITIONERS’31 EXPERT WITNESSES’ QUALIFICATIONS
AND OPINIONS
In this case, Petitioners relied upon expert reports of two medical experts for the
proposition that vaccinations harmed C.A.P. -- Joseph Bellanti, M.D. (Exs. 87 and 89), and Jean-
Ronel Corbier, M.D. (Exs. 98-99).32 These two experts, Drs. Bellanti and Corbier, each relied on
multiple factual assumptions about C.A.P.’s medical history that are at variance with his medical
records. Thus, at this point, I will briefly summarize both the qualifications and opinions of
these two expert witnesses, as they relate to the present “fact ruling.”
A. Petitioners’ expert Dr. Joseph Bellanti
1. Qualifications
Joseph Bellanti, M.D., earned his medical degree from the University of Buffalo School
of Medicine in 1958. (Ex. 88, p. 3.) He subsequently completed his internship at Millard
Fillmore Hospital in 1959, and his residency in pediatrics at Children’s Hospital of Buffalo in
1961. (Id.) From 1961 to 1962, he was a special National Institute of Health (NIH) trainee in
Immunology at the University of Florida, subsequently working as a research virologist at Walter
Reed Army Institute of Research, from 1962 to 1964. (Id.)
Dr. Bellanti has held a faculty position at Georgetown University School of Medicine
since 1963, rising to the position of Professor of Pediatrics and Microbiology-Immunology in
31 Respondent has also filed the expert reports of two highly qualified expert witnesses, but
I have not summarized those reports in this Ruling, since they are for the most part not relevant
to the factual rulings that I am making in this Ruling. However, I do note that, unlike the
Petitioners’ two primary causation experts, Respondent’s experts relied upon the facts contained
in the medical records, rather than upon the additional representations in the Petitioners’ joint
affidavit filed as Ex. 58.
32 Petitioners also submitted an expert report of Brett Abrahams, Ph.D., but that report only
disputes a point in the report of Respondent’s expert. Dr. Abrahams does not opine that
vaccinations harmed C.A.P. (See generally Ex. 96.)
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1970. (Ex. 88, p. 3.) Since 1975, Dr. Bellanti has concurrently served as the Director of the
International Center for Interdisciplinary Studies of Immunology at Georgetown University. (Id.)
Since 1980, he has also served as the Director of the Division of Immunology and Virology in
the Department of Laboratory Medicine at Georgetown University. (Id.) Additionally, he holds
an academic staff position in pediatrics at the Children’s Hospital National Medical Center,
concurrently holding clinical positions in the pediatrics departments of Arlington Hospital and
INOVA Fairfax Hospital. (Id., p. 1.)
Dr. Bellanti is certified by the American Board of Pediatrics, and holds the accreditation
of a “Diplomate” from the American Board of Allergy and Immunology, and from the National
Board of Medical Examiners. (Ex. 88, p. 4.)
Dr. Bellanti lists numerous accomplishments in his curriculum vitae. (See generally Ex.
88.) He has held over a dozen leadership positions in various scientific societies, and presently
serves on the editorial board of five scientific publications. (Id., pp. 5-6.) He has co-authored
more than 200 research articles and more than 150 abstracts in peer-reviewed journals. (Id., pp.
9-38.) He has also co-authored over 50 medical texts/book chapters (id., pp. 38-39), and has
been invited to give numerous presentations internationally (id., pp. 9-11).
2. Summary of Dr. Bellanti’s opinion
Dr. Bellanti opined that a “causal relationship” existed between the vaccines administered
to C.A.P. in his first year of life, and his current “neurologic and developmental abnormalities.”
(Ex. 89, p. 2 of 3.) Specifically, he asserted that C.A.P.’s current developmental abnormalities
are due to brain injuries caused by “repeated allergic (immune mediated) reactions to his
vaccines received in 2002.” (Ex. 87, p. 3 of 5, parenthetical in original.)
Notably, Dr. Bellanti based his opinion on parental testimony, describing symptoms
allegedly suffered by C.A.P. immediately after he was administered each set of vaccinations
during his first year of life. (Ex. 87, pp. 1-2 of 5.) In this regard, Dr. Bellanti asserted that C.A.P.
“reacted similarly to each of his sets of vaccinations,” including the “final Hepatitis B
vaccination.” (Id., p. 3 of 5.) He opined that C.A.P.’s alleged post-vaccination symptoms after
receiving each set of vaccinations, were, in fact, “reactions” to his administered vaccinations,
deeming those “reactions” as “clearly” demonstrating that C.A.P. “was allergic to some
components of the vaccines.” (Id.)
Moreover, as to how C.A.P.’s particular condition was caused by the vaccinations
administered to him in his first year of life, Dr. Bellanti seemed to simply rely on a temporal
association. (Ex. 89, p. 3 of 3, ¶¶ 2 and 3.) In describing that alleged temporal association, Dr.
Bellanti opined that C.A.P.’s case reflected “the striking history of a well child” who allegedly
sustained “fever,” “high pitched cry,” and “developmental abnormalities” after his vaccinations.
(Id.)
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B. Petitioners’ expert, Dr. Jean-Ronel Corbier
1. Qualifications
Jean-Ronel Corbier, M.D., earned his medical degree from Michigan State University,
College of Human Medicine, in 1995. (Ex. 99, p. 6 of 10.) He completed his residency in
pediatrics at Hurley Medical Center in 1997, later completing training in adult neurology at the
University of Cincinnati in 1998. (Id.) In 2000, he completed a fellowship in pediatric neurology
from the Children’s Hospital Medical Center in Cincinnati, Ohio. (Id.) Since 2000, Dr. Corbier
has been in private practice as a pediatric neurologist. (Id., p. 8 of 10.) He is a member of
several medical organizations, including the Child Neurology Society, American Academy of
Neurology, the Medical Association of the State of North Carolina, and the American Board of
Medical Specialists. (Id.) Dr. Corbier’s curriculum vitae reflects that he has authored three
books, in addition to co-authoring one research article, and has one research publication
pending.33 (Id., p. 9 of 10.) He has also been invited to give several presentations in his medical
specialty. (Id.)
2. Summary of Dr. Corbier’s opinion
Dr. Corbier opined that “it is more likely than not” that C.A.P. “was vaccine injured,” and
that his “immunizations led to a chronic brain disorder” -- a brain disorder he varyingly termed
as “static encephalopathy” or “chronic encephalopathy.” (Ex. 98, p. 3 of 3; Ex. 99, pp. 4-5 of
10.) Regarding C.A.P.’s alleged “static encephalopathy,” Dr. Corbier asserted that “[a]ll of
[C.A.P.]’s problems” were essentially “the expression of his static encephalopathy” that
“manifested within a day of his vaccinations.” (Ex. 99, p. 5 of 10.) At another point in his
reports, Dr. Corbier termed C.A.P.’s alleged brain disorder as “Vaccine Induced Encephalitis,”
defining that term as “an inflammation of the brain caused by vaccines.” (Ex. 98, p. 4.)
Dr. Corbier’s reports, however, were unclear as to exactly what vaccinations allegedly
caused C.A.P.’s encephalopathy. In his first expert report, Dr. Corbier seemed to point
exclusively to C.A.P.’s vaccinations of July 22, 2002, asserting that the “records show a
significant vaccine reaction” at that time, and opining that that alleged “vaccine reaction” caused
C.A.P. to “become lethargic,” “lifeless,” and “febrile” within 72 hours of his vaccinations. (Ex.
98, pp. 2 and 3 of 3.) In this regard, Dr. Corbier opined that after C.A.P.’s vaccinations of July
22, 2002, at age “7-months,” C.A.P. suffered from a “series of neurological and immune
problems,” which, by “15-18 months” of age, led to C.A.P. developing “clear regressive
symptoms,” and becoming “encephalopathic.” (Id., p. 3 of 3.)
In his supplemental expert report, however, Dr. Corbier instead seemed to substantially
change his causation opinion. Instead of pointing to all of C.A.P.’s vaccinations of July 22,
2002, he now pointed to the pertussis vaccinations (as part of the DTaP vaccinations)
administered to C.A.P. on several occasions during his first year of life. (Ex. 99, pp. 3, 4 of 10.)
In this regard, Dr. Corbier opined that the pertussis vaccinations caused C.A.P. to experience
numerous symptoms, such as -- “irritability,” “high fever,” “lethargic state,” “decreased
responsiveness,” “rash,” “fussiness,” and “decreased consciousness.” (Ex. 99, p. 4 of 10.)
33 Dr. Corbier’s research article appears to have been pending as of December 4, 2015, the
date on which his curriculum vitae was submitted in this case.
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Moreover, he deemed those alleged symptoms to be “evidence” of an “acute encephalopathy,”
which, according to Dr. Corbier, occurred on the “same day” as C.A.P.’s administered DTaP
vaccinations of “2/5/2002, 4/9/2002, 7/22/2002 and 9/24/2002.” (Id.)
Dr. Corbier further opined that C.A.P.’s “acute encephalopathy” eventually progressed to
a “chronic encephalopathy,” defining C.A.P.’s “chronic encephalopathy” to be “characterized by
dysfunction in his cognitive and social skills.” (Ex. 99, p. 3 of 10.) Moreover, he alleged that
certain of C.A.P.’s alleged symptoms -- “fever,” “irritability,” “decreased responsiveness,” and
“rash” -- were observed within the “time period after immunization” during which children
experience an “increased risk of encephalopathy.” (Id.) Thus, he ultimately opined that C.A.P.’s
“chronic encephalopathy resulted from his pertussis vaccination.” (Id.)
Dr. Corbier acknowledged, however, that C.A.P.’s “medical records did not document”
“certain symptoms” that allegedly were suffered by C.A.P. (Ex. 98, p. 3 of 3.) Thus, Dr. Corbier
admitted to relying on parental assertions of C.A.P.’s alleged medical history, in order to
formulate certain factual assumptions upon which his expert opinion is based in this case. (Ex.
98, p. 3 of 3; Ex. 99, p. 3 of 10.)
VI
SCOPE OF RULING AND FACTUAL ISSUES TO BE DECIDED
The record in this case includes, as relevant to this Ruling, a large volume of medical
records, affidavits of Petitioners and their family friends, Mrs. Prokopeas’ testimony at the fact
hearing, and the reports of two experts for the Petitioners. Petitioners’ two experts both base
their causation opinions not primarily upon the medical records, but most heavily upon the
additional symptoms allegedly displayed by C.A.P. during his first years of life, as set forth in
the affidavits of the Petitioners and their friends, plus Mrs. Prokopeas’ hearing testimony.
Petitioners, thus, at this time seek my ruling concerning the facts of C.A.P.’s early years of life.
Specifically, I am asked to rule whether the additional facts alleged by C.A.P.’s parents and their
friends concerning C.A.P. -- i.e., those facts that do not appear in C.A.P.’s contemporaneous
medical records -- are accurate descriptions of C.A.P.’s medical history. Because of the absence
from the medical records of most of the symptoms alleged by the parents and family friends,
Petitioners’ counsel requested that I conduct a fact hearing, and rule upon whether the parental
and friend accounts can be credited. (ECF No. 116.)
To summarize my factual finding below, I do not find, to be reliable, the written and oral
testimony offered by C.A.P.’s parents and family friends, alleging that C.A.P. suffered additional
post-vaccination symptoms after each set of vaccinations administered to C.A.P. in his first year
of life -- i.e., alleged symptoms that are not already reflected in his contemporaneous medical
records. I emphasize that I am not questioning the sincerity or honesty of the Petitioners, or the
other affiants. I simply find the contemporaneous medical records, reflecting C.A.P.’s condition
at the time his parents sought medical care during his first year of life, to be more reliable.
To summarize my discussion below, I first set forth, in Section VII, my general reasons
for relying on the contemporaneous medical records from C.A.P.’s first year of life over the
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written and oral testimony of the Petitioners and additional affiants, alleging that C.A.P. suffered
additional post-vaccination symptoms after each set of vaccinations. Thereafter, in Section VIII,
I set forth my reasons as to why I find two specific parental narratives of C.A.P.’s medical
history, as relayed to C.A.P.’s medical care providers at Ex. 5, pp. 2-3, and Ex. 69, pp. 4-5, to be
inconsistent with C.A.P.’s earlier contemporaneous medical records, and thus, I find them to be
unreliable. Next, in Section IX, in order to provide clarity, I list some of the critical assertions of
the Petitioners and their close family friends that I specifically reject. Thereafter, in Section X, I
list the incorrect assumptions of fact found in Petitioners’ expert reports from Drs. Bellanti and
Corbier. Finally, in Section XI, I issue a warning to Petitioners’ counsel to carefully assess the
reasonableness of moving forward with this case.
VII
GENERAL REASONS FOR MY FINDING THAT C.A.P.’S MEDICAL RECORDS
FROM HIS FIRST YEAR OF LIFE ARE MORE RELIABLE THAN LATER PARENTAL
AND FRIEND STATEMENTS ALLEGING ADDITIONAL SYMPTOMS NOT
REFLECTED IN THOSE MEDICAL RECORDS
In the discussion below, I highlight several reasons as to why I find C.A.P.’s medical
records from his first year of life, reflecting C.A.P.’s symptoms as contemporaneously reported
by his parents to his medical care providers, to be much more reliable than the parental and
friend narratives, made later in time, concerning his alleged post-vaccination symptomatology.
Specifically, I reject the statements made by Petitioners and their friends in the course of this
litigation, alleging additional symptoms purportedly suffered by C.A.P. after each set of
vaccinations administered to him in his first year of life -- i.e., alleged symptoms that are not
reflected in his contemporaneous medical records.
A. The stark contrast between the contemporaneous medical records and the affidavits and
fact hearing testimony of Petitioners and friends
The chief reason why I must credit the contemporaneous medical records over the
proffered affidavits and the fact hearing testimony of Mrs. Prokopeas is simply that there was
such a stark contrast between the contemporaneous medical records and the affidavits/fact
hearing testimony. The affidavits and fact hearing testimony allege that C.A.P. suffered a
number of very dramatic and serious symptoms, in close proximity to each of his 2002
vaccinations. Yet those serious or dramatic symptoms were not recorded at all in the
contemporaneous medical records. This stark contrast simply makes the parents’ and friends’
later recollections seem unbelievable. That is, if in fact C.A.P.’s symptoms took place as the
parents and friends later alleged, then his parents, as concerned, caring parents, would certainly
have reported those symptoms during their many contacts with C.A.P.’s medical care providers
throughout his first year of life. The absence of those symptoms in the contemporaneous
medical records indicates that the parents and friends are not remembering C.A.P.’s symptoms
accurately. Some examples of this stark contrast are detailed below.
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1. Example one: Alleged symptoms after vaccinations of February 5, 2002
As the first example, Mrs. Prokopeas testified that “within a few minutes” of C.A.P.’s
first set of vaccinations, on February 5, 2002, he began to scream and cry uncontrollably,
followed by a “deep sleep for many hours.” (Ex. 58, p. 1; Tr. 11-14.) She alleged that even after
C.A.P. woke up he was screaming and crying, rejected nursing, had lost his appetite, appeared
“very weak,” and ran a fever of 103.9 degrees Fahrenheit overnight. (Tr. 14-15.) Mrs. Prokopeas
added that she called C.A.P.’s pediatrician the next morning (i.e., on February 6, 2002), to report
those symptoms. (Tr. 15.) Additionally, Mrs. Prokopeas alleged that C.A.P. rejected nursing for
five days after February 5. (Ex. 58, p. 1, ¶ 4.)
The contemporaneous medical records, however, present an entirely different story. The
record of the visit of February 5 indicates that several vaccinations were given, but does not
indicate any reaction at all to them. (Ex. 34, p. 34 of 39.) Further, while other phone calls on
other days by C.A.P.’s parents to his pediatricians were explicitly recorded in the pediatrician’s
records (e.g., Ex. 34-2, pp. 31, 36, 37; Ex. 10, p. 4 of 15), there is no mention in the medical
records of any call on February 6, 2002. (Ex. 34-2, pp. 34-35.) Finally, during C.A.P.’s next
regular visit on April 9, 2002, no mention is made of any unusual behavior by C.A.P. after the
February 5 vaccinations. (Ex. 34-2, p. 35.)
Thus, if after the February 5 vaccinations, C.A.P. really had screamed uncontrollably, run
a fever of 103.9 degrees, and stopped nursing for five days, it seems extremely likely to me that
C.A.P. would have been taken back to the pediatrician, and such symptoms would have been
recorded in the medical records.
2. Example two: Alleged symptoms after vaccinations of April 9, 2002
Mrs. Prokopeas also asserted that after receiving his vaccinations of April 9, 2002, C.A.P.
experienced symptoms “very similar” to those that he had after his first set of vaccinations (i.e.,
screaming, uncontrollable crying, rejecting nursing, falling into a deep sleep, and developing a
fever). (Tr. 16-17; Ex. 58, p. 1, ¶ 5.) She stated that she called C.A.P.’s pediatrician after that
incident, but was assured that C.A.P.’s symptoms were normal. (Ex. 58, p. 1, ¶ 5.)
However, again the contemporaneous records of C.A.P.’s pediatrician contradict Mrs.
Prokopeas’ testimony. The record of April 9, 2002, does not indicate any immediate reaction by
C.A.P. to his vaccinations (Ex. 34-2, p. 35 of 39), and there is no mention anywhere in the
contemporaneous medical records of any symptoms in C.A.P. around this time period, or of any
phone call or visit by C.A.P.’s parents to the practice on or soon after April 9. Further, on the
same page as the record of the pediatric visit of April 9, 2002, there is a note concerning another
pediatric visit later that month. (Ex. 34-2, p. 35 of 39.) The date of that visit was miswritten on
the medical chart, recorded as “04/300/2.” But it seems clear that the actual visit date was April
30, 2002, with the second “slash” having been accidentally misplaced -- the apparent intent was
to write “04/30/02.” And that record of April 30, 2002, makes no mention of any symptoms by
C.A.P. in the several days after the vaccinations on April 9, 2002, much less the serious,
dramatic symptoms reported by Petitioners in this litigation. The April 30 notation states only
that C.A.P. had suffered from a cough, a runny nose, and a “rash throughout body,” for one week
prior to the April 30 visit, or since April 23, 2002.
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3. Example three: Alleged symptoms after vaccinations of July 22, 2002
Describing C.A.P.’s alleged symptomatology after his vaccinations of July 22, 2002,
Mrs. Prokopeas indicated that his third set of vaccinations “seemed to do the most harm so far.”
(Ex. 58, p. 1, ¶ 6.) She stated that C.A.P. had “[v]ery much the same symptoms” as he had after
his first two rounds of vaccinations (i.e., screaming, uncontrollable crying, rejecting nursing,
falling into a deep sleep, and developing a fever). (Tr. 20; Ex. 58, pp. 1-2.) She testified that
C.A.P. had a fever of 103.9 degrees Fahrenheit on the night of July 22 -- a temperature that she
alleged lasted “for days.” (Ex. 58, pp. 1-2; Tr. 20-21.)
Mrs. Prokopeas testified that she called C.A.P.’s pediatrician’s office on July 23, 2002,
and spoke with a nurse, reporting that C.A.P. had a fever, was miserable, could not open his
eyes, rejected nursing, seemed to be “very weak,” and “appeared lifeless.” (Tr. 21-22.) She
further testified that when C.A.P.’s pediatrician called her back later that same day, she told the
pediatrician that C.A.P. had the “same symptoms” as earlier that day. (Id.)
However, again the contemporaneous records paint quite a different picture. Those
records indicate a call from Mrs. Prokopeas on July 23, 2002, reporting a fever of 102-103
degrees, and that C.A.P. had been “fussy,” but that he was feeling better after taking Motrin, and
was “eating ok.” (Ex. 34-2, p. 36 of 39.) The records indicate a second phone call that day
between Mr. Prokopeas and the office, recording that C.A.P. still had a fever of 102-103 degrees,
but that he was also “playful,” and had no other symptoms beside the fever. (Id., p. 37.) The
records further reflect that C.A.P. was taken back to his pediatrician on July 24, with a fever of
up to 103 degrees, with his parents then describing him as “not himself.” (Id.) C.A.P. was also
taken to another pediatrician, Dr. Porter, on July 25, with a brief history of fever, vomiting, and
diarrhea; but at that visit C.A.P. was also reported to have breastfed three times that day with no
further diarrhea, and Dr. Porter observed C.A.P. to be “happy” and “playful.” (Ex. 10, p. 4 of
15.)
In other words, the medical records tell a distinctly different story from that told by
Petitioners’ proffered affidavits and testimony, concerning the time period immediately after the
vaccinations of July 22, 2002. There was no mention whatsoever in the medical records of the
screaming, uncontrollable crying, or an extended refusal to nurse, as alleged by Petitioners in this
Program proceeding. Instead, in the phone call records of July 23, C.A.P. is described as “eating
ok,” and as having no other symptoms except for fever. (Ex. 34-2, p. 36 of 39.) And in the
records of July 24 and 25, C.A.P. is described not as miserable, but as “playful” (Ex. 34-2, p. 37
of 39; Ex. 10, p. 4) and “happy” (Ex. 10, p. 4).
4. Example four: Symptoms after vaccination of September 24, 2002
Mrs. Prokopeas stated that after C.A.P.’s Hepatitis B vaccination of September 24, 2002,
C.A.P. experienced symptoms “almost identical” to those that he had experienced after his prior
rounds of vaccinations. (Tr. 32-34; Ex. 58, p. 2.) She alleged that immediately after that
vaccination, C.A.P. started crying, was screaming, was “very upset,” rejected nursing, was
unhappy, and slept for “many hours.” (Id.) She further testified that those symptoms continued
for a week, and she noticed him “getting worse,” prompting her to take C.A.P. to the pediatrician
on September 30, 2002. (Tr. 34; Ex. 58, p. 2.) Mrs. Prokopeas recalled reporting to the
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pediatrician that C.A.P. was “just very, very sick,” additionally reporting that he was not nursing
and was screaming. (Tr. 34.)
However, the actual record of the visit on September 30 states only that C.A.P. had
congestion and a runny nose for three days, plus sneezing, vomiting, teething, and poor sleep.
(Ex. 10, p. 3 of 15.) No mention was made of screaming, uncontrollable crying, or fever. (Id.)
5. Summary concerning this “stark contrast”
As these four examples demonstrate, the very stark contrast between (1) the allegations of
the Petitioners’ proffered affidavits and testimony, and (2) the actual contemporaneous medical
records, are a strong reason why I find the contemporaneous medical records to be much more
reliable than the allegations of the parents and friends made in this litigation.
6. Additional reason for finding the stark contrast to be problematic
This is especially true since the medical records, taken as a whole, indicate that C.A.P.’s
parents were not shy about communicating with C.A.P.’s health care providers by telephone, or
through office visits, during C.A.P.’s first year of life. See “patient phone call records” of:
December 27, 2001 (Ex. 34-2, p. 31); July 23, 2002 (Ex. 34-2, p. 36); July 23, 2002 (Ex. 34-2, p.
37.); and August 13, 2002 (Ex. 10, p. 4 of 15). See also C.A.P.’s office visits of: December 11,
2001 (Ex. 34-2, p. 30); December 20, 2001 (id., p. 32); December 27, 2001 (id., pp. 31-32);
January 8, 2002 (id., p. 33); February 5, 2002 (id., p. 34); April 9, 2002 (id., p. 35); April 30,
2002 (id., p. 35); July 22, 2002 (id., p. 36); July 24, 2002 (id., p. 37); July 25, 2002 (Ex. 10, p. 4
of 15); August 14, 2002 (id.); September 24, 2002 (id., p. 3 of 15); and September 30, 2002 (id.).
Therefore, since C.A.P.’s parents were quick to report by phone relatively minor symptoms of
C.A.P., and to bring him in to the doctor with relatively minor ailments, it seems extremely
unlikely that they would have failed to bring C.A.P. in, or even to report the symptoms during
C.A.P.’s next visit, if in fact C.A.P. actually displayed the dramatic and serious symptoms
reported in the affidavits and testimony of the parents and friends.
B. Other reasons for rejecting the Petitioners’ and friends’ allegations of symptoms that are
not reported in the contemporaneous medical records
1. Mrs. Prokopeas’ fact hearing testimony suffered from several flaws, and was
unpersuasive overall.
As part of my reasons for my general conclusion set forth in this Section VII, I note
specifically that I cannot credit the fact hearing testimony, of Mrs. Prokopeas, for additional
reasons as well. Her testimony suffered from extensive flaws, rendering her entire testimony to
be unpersuasive overall. Specifically, Mrs. Prokopeas’ testimony (1) appeared to be mainly a
recitation of her written notes, and (2) was compromised by Petitioners’ counsel’s strategy of
asking leading questions throughout the fact hearing -- both of which led me to question whether
Mrs. Prokopeas, by the time of hearing (14 years after the vaccinations in question), had an
accurate, independent recollection of C.A.P.’s early months of life.
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a. Mrs. Prokopeas’ fact hearing testimony appeared to be a recitation of her
written notes.
I highlight that for the majority of her fact hearing testimony, Mrs. Prokopeas appeared to
be reading from prepared written notes that she had with her on the witness stand. Hence,
instead of relying on her memory to offer an accounting of C.A.P.’s alleged post-vaccination
symptoms, Mrs. Prokopeas’ oral testimony was, in essence, a reading of her prepared notes.
(E.g., Tr. 11-12 (reading from a “piece of paper”); Tr. 14 (Mrs. Prokopeas stating that “looking
at my records,” C.A.P. had a fever of “103.9” degrees Fahrenheit after his vaccinations of
February 5, 2002); Tr. 17 (after Mrs. Prokopeas stated that she was “looking at my notes,” she
proceeded to testify about C.A.P.’s symptoms after his vaccinations of April 9, 2002); Tr. 26-27
(Mrs. Prokopeas appeared to be reading from her notes while testifying about C.A.P.’s
symptoms after his vaccinations of July 22, 2002); Tr. 28-29 (Mrs. Prokopeas appeared to be
reading from her notes while testifying about C.A.P.’s alleged lack of eye contact after his
vaccinations of July 22, 2002); Tr. 33-34 (Mrs. Prokopeas appeared to be reading from her
prepared notes while testifying about C.A.P.’s symptoms after his vaccination of September 24,
2002).)
I further note that at the fact hearing, Petitioners’ counsel acknowledged that at least one
of those prepared records relied upon by Mrs. Prokopeas during her testimony was Exhibit 58 --
i.e., Petitioners’ joint affidavit. (Tr. 26-27.) Moreover, I then requested that Mrs. Prokopeas
discontinue reading from that affidavit, encouraging her to rely instead upon her memory to
testify about C.A.P.’s post-vaccination symptoms during his first year of life. (Tr. 26-27.)
However, even after I made several requests that she discontinue reading from her prepared
notes (e.g., Tr. 27-29), Mrs. Prokopeas failed to comply, and continued reading from those notes
(Tr. 33-34). Thus, for that reason alone, I found Mrs. Prokopeas’ testimony at the fact hearing to
be unpersuasive, and I cannot give it any substantial weight.34
b. Petitioners’ counsel asked leading questions throughout the fact hearing.
Another reason why I afford little weight to Mrs. Prokopeas’ testimony during the fact
hearing is that Petitioners’ counsel used a strategy of asking leading questions throughout that
hearing. In this regard, Petitioners’ counsel was blatantly obvious in asking leading questions in
order to elicit certain testimony to substantiate critical factual assumptions relied upon in the
Petitioners’ expert reports submitted in this case. I highlight two examples below.
In one such instance, Petitioners’ counsel asked repeated leading questions. (Tr. 18-19.)
Specifically, Petitioners’ counsel asked the following leading questions while questioning Mrs.
Prokopeas about C.A.P.’s visit to the pediatrician in April of 2002:
34 I am sympathetic to the fact that fourteen years after the events in question, Mrs.
Prokopeas could not reasonably be expected to remember all details of the events in question.
But since the entire purpose of the fact hearing was to buttress, by oral testimony, the
previously-filed affidavits, then it seemed pointless to me for Petitioners’ counsel to simply have
the witness read from the very affidavit that her testimony was intended to support. (Of course, I
fault Petitioners’ counsel, not Mrs. Prokopeas, for this flawed trial strategy.)
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Q: Okay. And that’s your recollection, that you took him in because he was having these
symptoms after the vaccinations, is that correct?
A: Well, I took him in because he still had the same symptoms. He was coughing; he had
a runny nose. It had been close to a week now. He didn’t have a fever, but he did have the
rash throughout his body.
Q: And that was – that rash had started shortly after the vaccinations; is that correct?
A: Yes. All of this has been going on since Tuesday. Since the day he was vaccinated.
(Tr. 18-19, emphasis added.)
Similarly, Petitioners’ counsel asked another clearly leading question in an attempt to
elicit testimony by Mrs. Prokopeas, specifically regarding C.A.P.’s alleged loss of eye contact
after his vaccinations of July 22, 2002 -- i.e., a critical alleged fact at variance with C.A.P.’s
contemporaneous medical records from his first year of life. In this regard, Petitioners’ counsel
attempted to elicit an answer from Mrs. Prokopeas to the following question at the fact hearing:
Q: Did you notice anything after those vaccines with regard to his eye contact and his
responding to you?
(Tr. 28, emphasis added.) At that point, I explicitly asked Petitioners’ counsel to discontinue
asking leading questions critical to substantiating Petitioners’ expert reports submitted in this
case. (Tr. 28-29.) However, Petitioners’ counsel continued to ask such leading questions to elicit
answers from Mrs. Prokopeas. (E.g., Tr. 33.)
Thus, this behavior -- i.e., Petitioners’ counsel’s repeated leading questioning at the fact
hearing -- added another reason for me to discount the accuracy of the testimony of Mrs.
Prokopeas at the fact hearing.
c. Phone log of C.A.P.’s pediatrician
Moreover, I highlight that Mrs. Prokopeas alleged that she made a telephone call to
C.A.P.’s pediatrician on February 6, 2002, to complain of C.A.P.’s symptoms after his
vaccinations of February 5, 2002. (Tr. 15.) Similarly, she also testified to making a telephone
call to the pediatrician on April 9, 2002, to complain of C.A.P.’s symptoms after his vaccinations
earlier that day. (Ex. 58, p. 1, ¶ 5.) However, the records from C.A.P.’s pediatrician at the time --
i.e., Pediatric Associates of Dallas -- do not reflect that his parents made contact with the office
on those dates. (See Ex. 34-2 generally.) In this regard, I note that the records from Pediatric
Associates of Dallas reflect that that pediatrician’s office kept relatively detailed records of
parental phone calls, prior to and after the dates upon which C.A.P.’s parents alleged they called
the pediatrician’s office. (See “patient phone call records” of December 27, 2001 (Ex. 34-2, p.
31)); July 23, 2002 (Ex. 34-2, pp. 36-37) (two separate call notes); and August 13, 2002 (Ex. 10,
p. 4 of 15). Thus, I find that it would be unlikely that a staff member from that pediatrician’s
office would not have documented the alleged phone calls on February 6 and April 9, 2002, if in
fact Mrs. Prokopeas had made those calls.
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d. Inconsistencies between affidavits and fact hearing testimony
I additionally note that were several internal inconsistencies between Mrs. Prokopeas’
written statements in the joint affidavit (Ex. 58) and her fact hearing testimony. I discuss a few
of those instances below.
i. C.A.P.’s alleged high fever after his vaccinations of February 5,
2002, and allegations of a phone call made to his pediatrician on
February 6, 2002
At the fact hearing, Mrs. Prokopeas asserted that after C.A.P.’s vaccinations of February
5, 2002, (1) C.A.P. ran a fever of 103.9 degrees that night, and (2) she called C.A.P.’s
pediatrician the morning of February 6, 2002, to report his fever symptoms. (Tr. 14-15.) I note,
however, that that oral testimony was inconsistent with written testimony provided by Mrs.
Prokopeas in her previously-filed affidavits.
For example, none of the affidavits submitted by Mrs. Prokopeas previously alleged that
C.A.P. had any type of high fever, much less a temperature of 103.9 degrees, after his
vaccinations of February 5, 2002. (See Ex. 58, p. 1 of 5 (discussing C.A.P.’s condition after his
vaccinations of February 5, 2002).) Additionally, another of her allegations at the fact hearing,
that she phoned the pediatrician’s office on February 6, 2002, was never mentioned in any of her
previous affidavits. (See generally Exs. 58, 91, and 101.)
ii. Allegations regarding the severity of certain of C.A.P.’s
symptoms after his vaccinations of July 22, 2002
In one of her affidavits, Mrs. Prokopeas asserted that C.A.P. experienced numerous
symptoms after his vaccinations of July 22, 2002. (Ex. 58, p. 2.) Specifically commenting on
some of those symptoms -- vomiting, fever, failure to nurse, and diarrhea -- Mrs. Prokopeas
stated that those symptoms were “still going on even three weeks later” (i.e., three weeks after
his vaccinations of July 22, 2002). (Id., emphasis added.) Moreover, Mrs. Prokopeas also
described additional symptoms as occurring in late July or August, including crying, being
miserable, only sleeping two hours per night, having intermittent “high fevers,” being difficult
and demanding, having a “lack of eye contact,” and developing “random outbursts” for no
apparent reason. (Id.)
At the fact hearing, however, Mrs. Prokopeas’ described C.A.P.’s symptoms after his
vaccinations of July 22, 2002, as being far less severe than those stated in her affidavit. (See Tr.
20-31 generally.) Notably, at the hearing, Mrs. Prokopeas did not describe C.A.P. having a lack
of eye contact,35 or having random outbursts in the period following his vaccinations of July 22,
2002. (Id.) Moreover, regarding C.A.P.’s symptoms of vomiting, inability to nurse, and diarrhea,
Mrs. Prokopeas did not state at the fact hearing that those symptoms were continuously ongoing
35 At this point in the fact hearing, I admonished Petitioners’ counsel for attempting to ask a
leading question, regarding C.A.P.’s alleged lack of eye contact immediately after his
vaccinations of July 22, 2002, in an attempt to elicit testimony from Mrs. Prokopeas concerning
that critical allegation of fact in this case. (Tr. 28-29.) However, Mrs. Prokopeas did not give an
answer to that leading question. (Id.)
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for three consecutive weeks after his vaccinations of July 22, 2002, as the Petitioners had alleged
in their joint affidavit. (Tr. 29-30; compare Ex. 58, p. 2.) In this regard, although Mrs.
Prokopeas testified about C.A.P. having symptoms on or about July 25, 2002, she also testified
that, after his sick visit on July 25, C.A.P. “seemed to have been getting better” (Tr. 29-30)
(although apparently he did “have some” symptoms again in the days prior to August 13, 2002
(Ex. 10, p. 4 of 15).)
C. Summary of Section VII
For all of the reasons outlined above in this Section VII, I find that C.A.P.’s medical
records from his first year of life, reflecting C.A.P.’s symptoms as contemporaneously reported
by his parents to his medical care providers for the purposes of seeking treatment, to be far more
reliable than the parental and friend narratives of his alleged post-vaccination symptomatology
made later in time, for the purposes of advancing this litigation. In this regard, I do not find
sufficient indicia of reliability in the written and oral testimony of Mr. and Mrs. Prokopeas, and
their friends, to credit their testimony over the evidence found in the contemporaneous records.
Thus, I generally reject allegations made by Petitioners and their close family friends of
additional post-vaccination symptoms purportedly suffered by C.A.P. after each set of
vaccinations -- i.e., alleged symptoms that are not reflected in C.A.P.’s contemporaneous
medical records from his first year of life.
VIII
I REJECT TWO SPECIFIC RETROSPECTIVE PARENTAL NARRATIVES GIVEN TO
C.A.P.’S MEDICAL CARE PROVIDERS CONCERNING HIS PURPORTED MEDICAL
HISTORY IN HIS EARLY MONTHS OF LIFE
In regard to the issue of determining an accurate medical history of C.A.P.’s first months
of life, I add that while I credit the contemporaneous medical records, I do not credit two specific
parental narratives given much later to C.A.P.’s medical care providers, concerning his medical
history from his early months of life. Those two unacceptable narratives are: (1) the medical
history reported by the Petitioners to Dr. Kotsanis during C.A.P.’s telephonic phone consultation
of January 6, 2004 (Ex. 5, pp. 2-4); and (2) the medical history reported by Mr. Prokopeas to Dr.
Brasted during C.A.P.’s psychological evaluation of October 11, 2004 (Ex. 69, pp. 4-5).
At the outset, I point out that in this case, as in most Program cases, I generally afford the
most weight to those medical histories that represent the contemporaneous recitation of
symptoms then taking place. In this case, however, the two particular medical histories listed
above do not contemporaneously describe symptoms then happening, or that happened in the
previous several days, but instead describe symptoms that allegedly happened more than a year
beforehand.36 And those two histories are so drastically inconsistent with the contemporaneous
medical records, as well as with the majority of the other medical histories contained in C.A.P.’s
medical records, that I cannot rely upon those two histories as accurate. In the discussion below,
36 Respondent’s expert, Dr. Judith Miller, also seemed skeptical of Dr. Kotsanis’ report, for
the same reason. (Ex. H, pp. 7-8 of 9.)
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I highlight the specific problems I have with each of those two purported medical histories, and
why I ultimately find them to be unreliable.
A. Parental narrative of C.A.P.’s medical history relayed to Dr. Kotsanis in the phone
consultation of January 6, 2004
1. The parental narrative of C.A.P.’s medical history, provided by Petitioners to Dr.
Kotsanis in January of 2004, is drastically at variance with the contemporaneous
accounts of C.A.P.’s symptomatology, given by Petitioners to his medical care
providers during his first year of life.
After carefully comparing the parental narrative of C.A.P.’s medical history given to Dr.
Kotsanis37 in January of 2004 with their other histories made to C.A.P.’s medical care providers
during his early years of life, I find that the medical history reported by the parents to Dr.
Kotsanis in January of 2004 is drastically at variance with the large majority of the medical
histories contained throughout C.A.P.’s medical records, as well as with all the medical records
made during C.A.P.’s first year of life.
In January of 2004, Petitioners recounted to Dr. Kotsanis a history of C.A.P.’s
developmental milestones, reporting that “C.A.P. had met all his developmental milestones until
July 2002, but that they started noticing problems after his vaccinations administered that
month.” (Ex. 5, pp. 2-3, emphasis added.) Thus, in January of 2004, C.A.P.’s parents reported
that they first noticed issues with C.A.P.’s development as early as July of 2002 (i.e., when
C.A.P. was approximately seven months of age). However, that accounting of the approximate
timeframe of when the Petitioners started noticing C.A.P.’s developmental problems is
inconsistent with prior and subsequent accounts given by the Petitioners to various other medical
care providers.
First, in statements made by Petitioners to C.A.P.’s various medical care providers prior
to January of 2004 -- i.e, from October 2003 to December 2003 -- the parents reported that they
started noticing problems with C.A.P.’s development (specifically with his verbalization skills),
after C.A.P.’s head injury in September or October of 2003. (E.g., Ex. 67, p. 3; Ex. 54-1, p. 3;
Ex. 54-1, p. 4; Ex. 54-2, pp. 43-44.)
37 I once again highlight that Dr. Kotsanis’ role in providing care for C.A.P. is unclear in
this case. Moreover, Ex. 25, p. 52 reveals that Dr. Kotsanis is a founding member of Defeat
Autism Now (“DAN”), an organization that promotes “alternative” theories concerning autism.
(Ex. 25, p. 52.) In this regard, I note that in his phone consultation note of January 6, 2004, Dr.
Kotsanis recorded that “[i]n the summer/fall of 2002,” C.A.P.’s parents attended one of Dr.
Kotsanis’ “public lectures” during which he advised them to “do a comprehensive pediatric
evaluation with a pediatrician that is aware of possible postvaccination injury.” (Ex. 5, p. 3.)
Thus, at the very least, it seems that as early as 2002, Dr. Kotsanis was actively advocating for
Petitioners to seek out pediatricians who believed in the idea of “possible postvaccination injury”
in relation to autistic children, and may have played some role in the parents’ decisions to
withhold future vaccinations. (Id.)
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Second, in several accounts given by C.A.P.’s parents after January of 2004, they once
again reported that they started noticing problems with C.A.P.’s development after his head
injury in September or October of 2003. (E.g., Ex. 16, p. 1; Ex. 9, p. 1.) For instance, in an
audiological evaluation of February 2004, Mrs. Prokopeas reported that her concerns about
C.A.P.’s development had “began in October of 2003, when [C.A.P.] had an injury to his
forehead.” (Ex. 16, p. 1, emphasis added.) Similarly, in a psychological evaluation of July of
2004, Mrs. Prokopeas gave the following accounting of C.A.P.’s developmental history:
This past November [of 2003] [C.A.P.]’s parents noted a substantial change in his
behavior. He began fussing and crying much more than previously had been the case, his
eye contact, reported as previously typical, became briefer and less consistent, he
responded less consistently to people speaking to him, and his attention span shortened
considerably, as well as he became more insistent upon things and activities being as he
preferred.
(Ex. 9, p. 1, emphasis added.)
Thus, in the time period surrounding the phone consultation of January 6, 2004, I can
point to six separate instances during which the Petitioners relayed to C.A.P.’s various medical
care providers that they first started noticing problems with C.A.P.’s development after his head
injury in September or October of 2003. (E.g., Ex. 67, p. 3; Ex. 54-1, p. 3; Ex. 54-1, p. 4; Ex. 54-
2, pp. 43-44; Ex. 16, p. 1; Ex. 9, p. 1.) In this regard, I highlight that the approximate timeline
provided by Petitioners to Dr. Kotsanis in January of 2004, specifically regarding when the
parents first started noticing C.A.P.’s developmental problems, is drastically inconsistent and at
variance with the majority of such timelines provided to other of C.A.P.’s medical care
providers.
Thus, for the reasons stated above, I find Petitioners’ observations to Dr. Kotsanis in
January of 2004, concerning C.A.P.’s developmental history, to be so inconsistent with the
majority of the other medical histories relayed by them, that I do not rely on the medical history
found on Ex. 5, pages 2-3.
B. C.A.P.’s purported medical history reported by Mr. Prokopeas during C.A.P.’s
psychological evaluation in October of 2004
I additionally note that the medical history provided by Mr. Prokopeas during C.A.P.’s
psychological evaluation of October 2004, was also substantially different from the majority of
the medical histories contained in the record of this case. Specifically, on October 11, 2004,
C.A.P. underwent a psychological evaluation by William Brasted, Ph.D. (Ex. 69.) At that time,
Mr. Prokopeas reported an oral history of C.A.P.’s development to Dr. Brasted. In relevant part,
Dr. Brasted recorded the following about C.A.P.’s developmental history:
At 9-12 months, the family noticed that [C.A.P.] was not achieving developmental
milestones within normal limits. He [sic] speech appeared delayed. At 9 months of age,
[C.A.P.] appeared to have a reaction to his immunization shots. He began having temper
tantrums and banging his head at 12 to 14 months of age and was easily irritated.
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(Ex. 69, p. 4 of 5, emphasis added.) In other words, in October of 2004, Mr. Prokopeas relayed
to Dr. Brasted that the parents noticed C.A.P.’s developmental problems as early as September
of 2002 -- a time frame which is drastically inconsistent with the majority of the observations
provided to other of C.A.P.’s medical care providers. In fact, the large majority of the medical
histories given by Petitioners in the medical records submitted in this case reflect that the parents
started noticing problems with C.A.P.’s development after his head injury in September or
October of 2003. (E.g., Ex. 67, p. 3; Ex. 54-1, p. 3; Ex. 54-1, p. 4; Ex. 54-2, pp. 43-44; Ex. 16, p.
1; Ex. 9, p. 1.)
Moreover, as alleged in Dr. Brasted’s evaluation of October 2004, Mr. Prokopeas’ report
that C.A.P.’s alleged temper tantrums and head-banging started as early as when C.A.P. was “12
to 14 months” of age, is greatly at variance with other medical histories provided of C.A.P. (Ex.
69, pp. 4-5.) In fact, in numerous medical histories provided to C.A.P.’s medical care providers
prior to C.A.P.’s evaluation in October of 2004, C.A.P.’s parents make no mention of his temper
tantrums and head-banging symptoms as having started as early as when he was twelve months
of age. (E.g., Ex. 67, p. 3; Ex. 54-1, p. 3; Ex. 54-1, p. 4; Ex. 54-1, pp. 29-31; Ex. 54-2, pp. 43-44;
Ex. 16, p. 1; Ex. 9, p. 1; Ex. 18, p. 7.)
Similarly, in medical histories contained in C.A.P.’s medical records subsequent to his
evaluation of October 2004, his parents again reported a version of C.A.P.’s medical history that
contradicts Mr. Prokopeas’ statements in October of 2004. For instance, on November 8, 2004,
C.A.P. was examined by Dr. Tardo for a possible autism diagnosis. (Ex. 75, p. 2.) At that time,
Dr. Tardo recorded an oral history of C.A.P.’s development, as reported to her by Mrs.
Prokopeas. (Id.) In that history, Mrs. Prokopeas made no mention of C.A.P.’s head-banging
symptoms. (Id.) Moreover, during Dr. Tardo’s evaluation of November 8, 2004, Mrs. Prokopeas
reported that she became concerned about C.A.P.’s development “when he was approximately
20 months of age,” but that she initially thought that C.A.P. was “just a late talker.” (Id.,
emphasis added.)
Because of the inconsistencies mentioned above, I find Mr. Prokopeas’ observations to
Dr. Brasted in October of 2004, concerning C.A.P.’s neurodevelopmental medical history, to be
drastically inconsistent with the majority of the other medical histories relayed by the Petitioners
in the medical records submitted in this case. Thus, I do not rely on the medical history found on
Ex. 69, pages 4-5 of 5.
C. Summary of Section VIII
As highlighted above, upon my close examination of C.A.P.’s medical records, I do not
credit two specific medical histories reported to C.A.P.’s medical care providers concerning
C.A.P’s medical history concerning his early months of life. I find Petitioners’ observations (1)
to Dr. Kotsanis in January of 2004, as reflected in Ex. 5, pp. 2-3, and (2) to Dr. Brasted in
October of 2004, as reflected in Ex. 69, pp. 4-5 of 5, to be drastically inconsistent with the
majority of the other medical histories reported by them in the medical records submitted in this
case. Hence, I do not find those two medical histories to be reliable.
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IX
SPECIFIC FACT FINDINGS
In this section, for the purpose of providing clarity to the record of this case, I summarize
some of the critical allegations made by C.A.P.’s parents that I specifically reject in this ruling
on the facts, for reasons explained above in Sections VII and VIII of this Ruling.
A. C.A.P.’s alleged additional symptoms after his vaccinations of February 5, 2002
Specifically, I do not find that on February 5, 2002, C.A.P. screamed and cried
uncontrollably, followed by a deep sleep. I also do not find that C.A.P.’s parents contacted his
pediatrician’s office on February 6, 2002, as later alleged by the Petitioners.
B. C.A.P.’s alleged additional symptoms after his vaccinations of April 9, 2002
I reject the Petitioners’ allegations that soon after his vaccinations of April 9, 2002,
C.A.P. suffered symptoms similar to those he allegedly experienced after his February 5
vaccinations, such as screaming and crying uncontrollably, and rejecting nursing. I reject Mrs.
Prokopeas’ testimony that the date of C.A.P.’s second visit to the pediatrician in April of 2002,
was on April 13 -- I find that it was April 30.
C. C.A.P.’s alleged additional symptoms after his vaccinations of July 22, 2002.
I reject the Petitioners’ allegation that shortly after his vaccinations of July 22, 2002,
C.A.P. had uncontrollable screaming and crying, and failed to nurse. I reject that C.A.P.’s
sleeping difficulties began soon after his vaccinations of July 22, 2002. I also reject Petitioners’
allegations that C.A.P.’s lack of eye contact began in the time period immediately after his
vaccinations of July 22, 2002. Further, I credit the notation in the record of the second phone
call of July 23, 2002, that C.A.P. was “playful,” and that he had no additional symptoms at that
time other than his fever.
D. Symptoms allegedly occurring after vaccination of September 24, 2002
I reject the Petitioners’ contention that after the vaccination of September 24, 2002,
C.A.P. had any symptoms other than the minor symptoms reported in the record of the visit of
September 30, 2002.
E. C.A.P.’s parents’ developmental concerns
I reject Petitioners’ allegations that they first noticed developmental problems with
C.A.P. at any time prior to his head injury in September or October of 2003.
F. The medical history recorded by Dr. Kotsanis during his telephone consultation of January
6, 2004
I reject, as inaccurate, the medical history recorded by Dr. Kotsanis in January of 2004,
as contained in Ex. 5, pp. 2-3.
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G. C.A.P.’s psychological evaluation of October 11, 2004
I specifically reject the medical history recorded by Dr. Brasted in October of 2004, as
contained in Ex. 69, pp. 4-5 of 5.
X
PETITIONERS’ EXPERTS RELIED ON NUMEROUS MISASSUMPTIONS OF FACT IN
FORMULATING THEIR RESPECTIVE EXPERT OPINIONS
Based on my factual findings above, I necessarily also find that Petitioners’ experts relied
on numerous misassumptions of fact in formulating their respective expert reports. I detail each
experts’ critical misassumptions of fact below.
A. Dr. Bellanti’s misassumptions of fact
In his expert report of July 8, 2013, Dr. Bellanti set forth the factual assumptions upon
which he based his expert opinion in this case. (Ex. 87, pp. 1-3) Specifically, Dr. Bellanti
heavily relied on the joint affidavit of Mr. and Mrs. Prokopeas, filed as Exhibit 58, to assume
certain facts concerning C.A.P.’s condition after each set of vaccinations administered to C.A.P.
during his first year of life. (E.g., Ex. 87, p. 1, ¶¶ 2, 4; Ex. 87, p. 2, ¶¶ 1, 3-7.)38
Additionally, in his expert report of July 8, 2013, Dr. Bellanti relied upon Dr. Kotsanis’
recorded medical history contained in Exhibit 5, deeming that recorded medical history as being
“an excellent history of what was going on at that time.” (Ex. 87, p. 2, ¶ 8.) Moreover, Dr.
Bellanti stated the following regarding the medical history recorded by Dr. Kotsanis in January
of 2004:
The history he recorded (Ex. 5, at 1-3) is entirely consistent with the narrative of
[C.A.P.]’s parents.
(Ex. 87, p. 3, parenthesis in the original.)
As discussed in Section VII above, however, I specifically reject Petitioners’ written and
oral statements in this case, testifying to additional post-vaccination symptoms allegedly suffered
by C.A.P. -- alleged symptoms that are not reflected in C.A.P.’s contemporaneous medical
records -- during his first year of life. Moreover, as also discussed above, I also specifically
38 See Ex. 87, p. 1, ¶ 4 (assuming as fact parental assertions of C.A.P.’s condition after his
vaccinations of February 5, 2002); Ex. 87, p. 2, ¶ 1 (assuming as fact parental assertions of
C.A.P.’s condition after his vaccinations of April 9, 2002); Ex. 87, p. 2, ¶¶ 3-4 (assuming as fact
parental assertions of C.A.P.’s condition immediately following his vaccinations of July 22,
2002); Ex. 87, p. 2, ¶ 5 (assuming as fact parental assertions as to the start of certain of C.A.P.’s
symptoms, including his lack of eye contact, following his vaccinations of July 22, 2002); Ex.
87, p. 2, ¶ 6 (assuming as fact parental assertions of C.A.P.’s condition after his vaccination of
September 24, 2002).
44

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reject the medical history recorded by Dr. Kotsanis in January of 2004, as contained in Ex. 5, pp.
2-3.
Thus, I emphasize that the majority of the factual assumptions reflected in both of the
expert reports of Dr. Bellanti submitted in this case (Exs. 87 and 89) are clearly erroneous.39
B. Dr. Corbier’s misassumptions of fact
Dr. Corbier relied on the assumptions that shortly after his vaccinations of February 5,
2002, C.A.P. “lost his appetite and slept for long hours at a time” (Ex. 98, p. 2 of 3), and that
soon after his vaccinations of July 22, 2002, C.A.P. became “lifeless” and “lethargic,” and was
“crying inconsolably” (Ex. 98, pp. 2-3 of 3). Dr. Corbier also assumed that C.A.P. had
“irritability” and a “lethargic state” after each of his vaccination sets on February 5, April 9, and
July 22. (Ex. 99, p. 3 of 10.)
However, as I have set forth above, I find that those were erroneous assumptions of fact,
upon which Dr. Corbier based his opinion.
C. Summary of my conclusions concerning Dr. Bellanti’s and Dr. Corbier’s expert opinions
For the reasons described in detail above, I find that the expert opinions of Drs. Bellanti
and Corbier in this case are based upon numerous flawed assumptions, with those erroneous
assumptions being strongly contradicted by C.A.P.’s medical records. Hence, I find that the
expert opinions of both Drs. Bellanti and Corbier40 are fatally flawed, and thus, wholly
unreliable.41
39 I note that, in serving as an expert witness for petitioners in prior Vaccine Act cases, Dr.
Bellanti has a history of basing his causation opinion on clearly faulty factual assumptions. In a
prior case before me in which Dr. Bellanti served as Petitioners’ expert witness, Brook v. HHS,
No. 04-405V, 2015 WL 3799646 (Fed. Cl. Spec. Mstr. May 14, 2015), I found that Dr. Bellanti’s
causation opinion in that case was “premised on assumptions that run contrary to the clinical
history presented by the medical records.” 2015 WL 3799646 at *11, emphasis in original.
40 Dr. Corbier also opined that C.A.P. suffered a “Table Injury encephalopathy” after his
vaccinations of July 22, 2002. (Ex. 99, p. 4 of 10.) However, after studying the medical records
of July 23, 24, and 25, 2002, it is absolutely clear that C.A.P. did not suffer such a Table Injury.
(That conclusion by Dr. Corbier, indeed, was, in my view, quite absurd.)
41 “To the extent that it relies on the testimony of the petitioners’ witnesses as to the
occurrence and timing of events, [expert medical opinion] must stand or fall with the fact
testimony.” (Murphy v. HHS, 90-882V, 1991 WL 74931, at *3 (Fed. Cl. Spec. Mstr. April 25,
1991) (aff’d, 23 Cl. Ct. 726 (1991), aff’d, 968 F.2d 1226 (Fed. Cir. 1992), cert. denied, 113 S. Ct.
463 (1992).) Thus, because I decline to credit Petitioners’ testimony with regard to C.A.P.
allegedly suffering from additional post-vaccination symptoms after each set of vaccinations,
including allegations that some of those post-vaccination symptoms constituted severe reactions
to his vaccinations in the immediate time period following his vaccinations, I likewise decline to
accept Drs. Bellanti’s and Corbier’s opinions based upon that testimony.
45

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XI
WARNING TO PETITIONERS’ COUNSEL CONCERNING “REASONABLE BASIS”
In several cases before myself and other special masters hearing cases involving children
with diagnoses on the autism spectrum, petitioners’ experts have relied upon parental testimony,
as opposed to the minor child’s medical records, in formulating factual assumptions upon which
they based their expert opinions. In many of those cases, parental testimony offered in the
course of litigation, alleging that the child suffered certain severe post-vaccination symptoms not
reflected in his/her medical records, is the exclusive or predominant evidence supporting the
factual assumptions of the petitioners’ experts. But in many of those cases, as in this case, a
careful examination of the record of the case has revealed that the child’s medical records
strongly contradicted the petitioners’ assertions that their child suffered any kind of serious
symptoms soon after his/her vaccinations in question. See, e.g., Hardy v. HHS, supra; Brook v.
HHS, supra; Hooker v. HHS, supra; Dempsey v. HHS, supra; Hashi v. HHS, No. 08-307V, 2015
WL 4626089 (Fed. Cl. Spec. Mstr. June 1, 2015). In certain of those cases, I have found that
petitioners’ proffered expert opinions were so divorced from the actual facts contained in the
child’s medical records, that in effect petitioners’ case, as presented, was simply frivolous. See,
e.g., Hardy v. HHS, supra; Hooker v. HHS, supra.
This case clearly fits such a fact pattern, as explained above. Therefore, I hereby notify
Petitioners’ counsel in this case, that if Petitioners choose to continue to pursue any further
proceedings in this case, after this point in time, I would be unlikely to conclude that there was a
“reasonable basis” for such further proceedings, and therefore would be unlikely to compensate
Petitioners for any further attorneys’ fees and/or costs incurred concerning this petition. (I think
it likely that any special master that might succeed me in this case would probably reach the
same conclusion.)
Further, I strongly advise petitioners’ counsel in all pending Vaccine Act cases that such
counsel should carefully scrutinize, for credibility, any cases in which an expert witness, opining
that vaccines caused or aggravated a minor child’s ASD or other neurologic disorder, bases an
expert opinion in a case in substantial part on parental allegations of the child undergoing certain
severe post-vaccination symptoms; if, as in this case, such alleged symptoms are not reflected in
the contemporaneous medical records of the child, I (or any special master) will be unlikely to
find that the use of such expert was reasonable, and thus compensable.
XII
CONCLUSION
Petitioners’ counsel is hereby ordered to carefully study these findings of fact. Expert
opinion inconsistent with these findings of fact is not likely to be persuasive. See Burns v. HHS,
3 F.3d 415, 417 (1993) (holding that the special master did not abuse his discretion in refraining
from conducting a hearing when the petitioner’s expert “based his opinion on facts not
46

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substantiated by the record”); Brooke Group Ltd. v. Brown & Williamson Tobacco Corp., 509
U.S. 209, 242 (1993) (“When an expert opinion is not supported by sufficient facts to validate it
in the eyes of the law, or when indisputable record facts contradict or otherwise render the
opinion unreasonable, it cannot support a jury’s verdict.”); Perreira v. HHS., 33 F.3d 1375, 1376
n.6 (Fed. Cir. 1994) (“An expert opinion is no better than the soundness of the reasons
supporting it.”); see also Bradley v. HHS, 991 F.2d 1570, 1574 (Fed. Cir. 1993) (the assumption
of an expert about the accuracy of a fact witness’s testimony does not “substantiate” the fact
witness’s testimony).
Moreover, I also strongly urge Petitioners’ counsel to comprehensively study C.A.P.’s
medical records, and this ruling on the facts, as discussed in Section X of this Decision above,
prior to proceeding further with this case.
IT IS SO ORDERED.
/s/ George L. Hastings, Jr.
George L. Hastings, Jr.
Special Master
47

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_04-vv-01717-2
Date issued/filed: 2019-06-18
Pages: 30
Docket text: PUBLIC DECISION (Originally filed: 05/24/2019) regarding 185 DECISION of Special Master. Signed by Chief Special Master Nora Beth Dorsey. (am) Service on parties made.
--------------------------------------------------------------------------------
Case 1:04-vv-01717-UNJ Document 186 Filed 06/18/19 Page 1 of 30
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: May 24, 2019
* * * * * * * * * * * * *
ELLENA PROKOPEAS and CHRIS * PUBLISHED
PROKOPEAS, Parents of C.A.P., *
A Minor, * Case No. 04-1717V
*
Petitioners, * Chief Special Master Dorsey
*
v. * Diphtheria-Tetanus-Acellular Pertussis
* (DTaP); Haemophilus Influenzae (Hib);
SECRETARY OF HEALTH * Inactivated Polio (IPV); Pneumococcal
AND HUMAN SERVICES, * Conjugate (Prevnar); Hepatitis B (Hep B);
* Table Encephalopathy; Static
Respondent. * Encephalopathy; Autism.
* * * * * * * * * * * * *
Curtis Webb, Twin Falls, Idaho, for petitioners.
Voris Johnson, United States Department of Justice, Washington, DC, for respondent.
DECISION1
I. Introduction
On November 29, 2004, Chris and Ellena Prokopeas (“petitioners”), parents of C.A.P., a
minor, filed a petition for compensation under the National Vaccine Injury Compensation
Program (“the Program”).2 Petitioners allege that the vaccines C.A.P. received on February 5,
1 Because this Decision contains a reasoned explanation for the action in this case, the
undersigned is required to post it on the United States Court of Federal Claims’ website in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). This means the Decision will
be available to anyone with access to the Internet. In accordance with Vaccine Rule 18(b),
petitioners have 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the
undersigned agrees that the identified material fits within this definition, the undersigned will
redact such material from public access.
2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42
U.S.C. § 300aa-10 et seq. (“Vaccine Act” or “the Act”). Hereinafter, individual section
references will be to 42 U.S.C. § 300aa of the Act.
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Case 1:04-vv-01717-UNJ Document 186 Filed 06/18/19 Page 2 of 30
2002, April 9, 2002, July 22, 2002, and September 24, 2002, caused him to develop
encephalopathy. Amended (“Am.”) Petition at 2-3 (ECF No. 51).3
Under the Program, petitioners may not receive compensation based solely upon their
claims, as the petition must be supported by either medical records or by the opinion of a
qualified physician to establish a causal relationship. See § 13(a)(1). Here, the medical records
do not support petitioners’ claims, and the proffered expert opinions fail to provide support for
the elements necessary to prove causation. For these reasons, and the reasons discussed below,
petitioners have failed to demonstrate that they are entitled to compensation, and thus their
petition must be dismissed.
II. Overview
This Decision should be read in concert with the Ruling on Factual Issues (“Ruling”)
issued on June 14, 2017. (ECF No. 131). The Ruling covers the procedural history, facts,
evidence, and applicable statutory scheme. In it, Special Master Hastings (to whom the case was
originally assigned) issued a number of specific factual rulings. I have reviewed all of the
exhibits, medical records, expert reports, literature, and all other filings, in accordance with the
applicable statutes, and I find the Ruling to be complete, accurate, and soundly reasoned. I agree
with it, adopt it, and incorporate it herein by reference as if fully set forth. This Decision begins
where the Ruling ends, addressing petitioners’ objections to Special Master Hastings’ Ruling and
resolving the issues of causation.
III. Procedural History
This is the last case from the Omnibus Autism Proceeding (“OAP”) remaining in the
Office of Special Masters. In his Ruling, Special Master Hastings thoroughly described the
procedural history of the case from the date of its filing in 2004 through the fact hearing held on
August 1, 2016. See Ruling at 7-10. The procedural history following that hearing is set forth
below.
After Special Master Hastings issued his Ruling, he ordered petitioners to file a motion
for a decision dismissing the petition, or a status report indicating how they planned to proceed.
Order dated July 6, 2017 (ECF No. 132). Special Master Hastings issued several orders granting
petitioners extensions of time for these filings, including one order in which he reiterated his
belief that the claim was unlikely to succeed. Order dated Aug. 23, 2017 (ECF No. 142). On
September 12, 2017, in light of Special Master Hastings’ retirement, this case was reassigned to
me. Notice of Reassignment dated Sept. 12, 2017 (ECF No. 144). I then gave petitioners 30
3 Petitioners initiated this claim by filing a “short-form autism petition,” effectively alleging that
C.A.P. had autism and making his case part of the OAP. See Petition (ECF No. 1); Autism
General Order #1, 2002 WL 31696785, at *4 (Fed. Cl. Spec. Mstr. July 3, 2002). They
amended their claim on August 15, 2011, after the OAP test cases found no reliable evidence
linking the vaccines in question to autism. See Am. Petition; Order dated June 14, 2011 (ECF
No. 48). For a thorough discussion of the OAP’s procedural history, please consult pages 4
through 7 of the Ruling.
2

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days in which to file updated medical records or other evidence. Order dated Oct. 27, 2018 (ECF
No. 150). In response, petitioners filed additional medical records, along with a memorandum
summarizing their position. See Petitioners’ Exhibits (“Pet. Exs.”) 103-11.4
On December 13, 2017, respondent filed a Motion for a Ruling on the Record. Mot. for a
Ruling on the Record (“Resp. Mot.”) dated Dec. 13, 2017 (ECF No. 156). Respondent also filed
a supplemental expert report from Dr. Gerald V. Raymond. Ex. U. On February 14, 2018,
petitioners filed a letter, in which they sought to amend their petition once again. Amendment
dated Feb. 14, 2018 (“2018 Amendment”) (ECF No. 166). The request to amend was denied
because the 2011 amended petition had already incorporated the requested amendments, and a
table encephalopathy claim had already been considered during the fact hearing. Order dated
Mar. 14, 2018 (ECF No. 168).
On August 22, 2018, the parties were given 30 days in which to file any additional briefs
that they deemed necessary. Order dated Aug. 22, 2018 (ECF No. 169). In response, petitioners
filed a status report and motion for an extension of time to file additional evidence, an amended
petition, and several other documents. Exs. 113-18. In their amended petition, petitioners
alleged that “[e]vidence has been discovered that C.A.P. has a Mitochondrial Metabolism
Disorder” that was significantly aggravated by his vaccinations. Ex. 117 at 8-9. Respondent
objected to petitioners’ attempt to re-open the record, arguing that these filings provided neither
new probative evidence nor any reasonable basis to continue to litigate the claims. Resp.
Response & Obj. dated Sept. 26, 2018 (ECF 172). Nonetheless, I allowed petitioners an
opportunity to file additional evidence by November 26, 2018. Order dated Sept. 26, 2018 (ECF
171).
On November 20, 2018, petitioners filed a motion to change their attorney of record to
Curtis R. Webb. Mot. dated Nov. 20, 2018 (ECF No. 173). The Clerk’s Office granted the
motion pursuant to Rule 83.1(c)(4). Mr. Webb then sought an extension of time to file the
results of a mitochondrial DNA test, as well as an expert report on the issue of whether C.A.P.
had a mitochondrial disorder. Pet. Mot. dated Nov. 26, 2018 (ECF No. 175). I discussed these
issues with the parties during a status conference held on November 29, 2018; I ultimately
granted petitioners’ motion to file the results of C.A.P.’s mitochondrial DNA testing, but not an
expert report. Order dated Dec. 3, 2018 (ECF 176). Mr. Webb filed the test results5 on February
4 On August 18, 2017, petitioners’ former counsel, Mr. Clifford Shoemaker, informed the Court
of his intent to withdraw from the case. Pet. Motion (“Mot.”) dated Aug. 18, 2018 (ECF No.
138). In anticipation of withdrawing, Mr. Shoemaker filed an application for interim attorneys’
fees and costs. See Pet. Application dated Sept. 29, 2017 (ECF No. 147). On December 5, 2017,
the undersigned issued a decision awarding interim fees and costs. Decision dated Dec. 5, 2017
(ECF No. 155). Petitioners’ counsel subsequently issued a motion to withdraw as attorney,
which was granted on December 19, 2017. Order dated Dec. 19, 2017 (ECF No. 158).
Petitioners were given 60 days to retain new counsel, but at that time they chose to proceed pro
se. See Order dated Nov. 29, 2017 (ECF No. 153).
5 C.A.P.’s mitochondrial DNA genetic testing results did not show any “clinically significant
variants” and were interpreted as normal. Ex. 119 at 1.
3

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5, 2019. Ex. 119. I subsequently issued an order stating that the record in the case was closed.
Order dated Feb. 7, 2019 (ECF 182).
The case is now ripe for adjudication of respondent’s Motion for a Ruling on the Record.
IV. Factual Issues
Petitioners assert that Special Master Hastings’ Ruling was not factually accurate in
several respects. Petitioners maintain that C.A.P. suffered from failure to thrive;6 that his
medical records did not accurately document certain symptoms; that he did not have autism; that
Special Master Hastings’ Ruling was improperly based on a diagnosis of autism; and that the
Ruling did not consider certain transcribed medical notes, which petitioners subsequently filed.
See generally Ex. 103.
A detailed chronology of C.A.P.’s medical records from his birth on December 6, 2001,
through approximately 2007 is set forth in the Ruling. The Ruling also includes a summary of
additional medical history reported by C.A.P.’s parents, as well as by family friends Nick
Chrissikos and Naomi de la Torre. I incorporate by reference all of these facts as set forth in the
Ruling.7
A. Additional Exhibits Filed After Ruling
Since the Ruling was issued, petitioners have filed additional exhibits, including a
Statement of Position; school evaluations from 2007 through 2017; a supplemental report by Dr.
Corbier; transcribed medical notes; a medical history summary; a growth weight chart; a
diagnoses chart; general information on autism and learning disabilities; a group of exhibits that
were previously filed;8 and mitochondrial DNA test results. See Exs. 103-19. I have reviewed
all of the additional exhibits and taken all of these into consideration. Below, I summarize only
those portions of the exhibits which are relevant to my Decision.
i. School Evaluations
Petitioners filed C.A.P.’s school evaluations for 2006 to 2017, chronicling kindergarten
through eighth grade. Ex. 104. The earliest evaluation, performed on September 11, 2006, when
C.A.P. was 4 years old, assessed whether C.A.P. met the disability requirements for autism. Ex.
28 at 2; Ex. 104 at 19. The results were summarized as follows:
6 “Failure to thrive” is defined as “physical and developmental retardation in infants and small
children, seen in those with a physical illness or suffering psychosocial effects such as maternal
deprivation. Characteristics include lack of physical growth and below normal achievement in
fine and gross motor, social-adaptive, and language skills as assessed by psychometric testing.”
Dorland’s Illustrated Medical Dictionary 678 (32d ed. 2012).
7 See Ruling at 10-28 (recitation of facts), 43-44 (specific findings of fact).
8 Exhibit 112 is a group of exhibits previously filed individually as Exhibits 58, 100, 102, and 99,
and it does not contain new information.
4

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In July of 2004 Dr. Gordon Bourland evaluated [C.A.P.] and identified him as a
child on the Autism Spectrum Disorder. In September of 2006 the Preschool
assessment team in Plano ISD conducted an assessment and gave [C.A.P.] an
Eligibility of NCEC9 with a suspicion of Autism. They refrained from making a
formal diagnosis at that time due to his young age and because of the scatter of
atypical behaviors observed during the assessment.
Ex. 104 at 119. Based on additional school assessments performed on December 5, 2007,
including the Gilliam Autism Rating Scale (“GARS”) and the Childhood Autism Rating Scale
(“CARS”), evaluators concluded that C.A.P.’s behavior was not consistent with autism. Id. at
117. When observed in the classroom, C.A.P. “appeared happy, . . . laughing and smiling with
his peers and engaged in verbal interaction with them.” Id. at 116. He “made excellent [eye]
contact and sustained interaction with his peers and his teacher.” Id. C.A.P. had no vision or
hearing abnormalities, his behavior was age appropriate, and he was able to dress himself. Id. at
113-15. Testing did not reveal a speech impairment. C.A.P. met eligibility requirements for
special education services based on a learning disability, but he did not meet criteria for a
pervasive developmental disorder (“PDD”)10 or autism. Id. at 120.11
An evaluation performed in 2009, when C.A.P. was in second grade, showed he had no
significant health issues and no physical conditions that affected his education. Ex. 104 at 97.
C.A.P. was described as “a very well behaved child at home,” and although he was “easily
distracted” in the classroom, he “responded well to encouragement.” Id. at 99, 103, 105. He was
assessed with receptive and expressive language deficits. Id. at 89. Evaluations performed in the
third and sixth grades continued to show deficits with reading comprehension and written
expression, but no emotional or behavioral problems. Id. at 52-83. The most recent evaluation
in eighth grade revealed improvement, but C.A.P. continued to have deficits in reading
comprehension. Id. at 21. Teachers reported that his emotional and behavioral skills were
average or above average. Id. at 6. C.A.P. was observed to follow oral and written instruction,
interact appropriately with his classmates, and engage with his peers during a small group
activity. Id. at 13. No significant emotional or behavioral problems at home were documented.
Id. at 5.
9 NCEC stands for “non-categorical early childhood,” a term used to describe a variety of
learning disabilities, intellectual disabilities, and developmental disorders. See Non-Categorical
Early Childhood, Special Educ. Info. Ctr., https://www.spedtex.org/index.cfm/parent-
resources/disabilities/non-categorical-early-childhood/ (last visited Apr. 27, 2019); Ex. 28 at 26.
10 Pervasive developmental disorder is defined as “a group of disorders characterized by
impairment of development in multiple areas, including the acquisition of reciprocal social
interaction, verbal and nonverbal communication skills, and imaginative activity, and by
stereotyped interests and behaviors.” Dorland’s at 552.
11 This 2007 evaluation and the evaluations done over the next ten years, which clearly show that
C.A.P. did not meet the criteria for ASD, call into question whether there was a reasonable basis
for petitioners to pursue the claim as part of the OAP after 2007, when they learned that their son
did not have an ASD diagnosis.
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ii. Transcribed Medical Notes and Medical History
In their Statement of Position, petitioners assert that Special Master Hastings’ Ruling was
“not factually medically accurate,” due in part to the unavailability of certain transcribed medical
notes. Ex. 103 at 1. Petitioners filed some transcribed medical notes as Exhibit 106, but
petitioners do not identify the person who transcribed the notes. The exhibit is not self-
authenticated, it is not signed by a notary, and it is not certified by a court reporter or other
person. The exhibit does not reference the exhibits or physician’s notes it purports to transcribe.
Presumably, it was transcribed by petitioners.
These transcribed notes are frequently inconsistent with the medical records. Most
notably, Exhibit 106 contains extraneous information not found in the medical records for the
relevant dates. For example, the first page of the exhibit includes an entry dated April 30, 2002,
referencing a call from C.A.P.’s mother regarding an appointment for C.A.P. later that day. The
entry states, “call not found in medical records.” Ex. 106 at 1. Additionally, some of the
transcribed notes do not accurately reflect the handwritten physician notes. For example, the
transcribed note dated July 23, 2002, states, “Very high fever of 102-103,” but the original
handwritten note from that visit states, “↑ temp 102-103.” Compare Ex. 106 at 3, with Ex. 34 at
36. The addition of the words “very high fever” is an inaccurate transcription of the note, which
is clear and legible.
Similarly, the transcribed note of July 24, 2002, appears inaccurate. The physical
examination is charted as follows:
6

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Id. at 37. The words to the right of “HEENT” are transcribed as “fast pulse,” but the words,
which are difficult to read, could also be “fax” or “f/u” (follow up). See Ex. 106 at 3. The
transcription also includes a two-paragraph discussion of acute gastroenteritis, which the
handwritten note does not contain. Compare Ex. 106 at 4, with Ex. 34 at 37.
Petitioners assign particular significance to two phrases allegedly documented in the July
24, 2002 note. First, petitioners assert that Dr. Ashley’s note “? Rx to shot” suggests vaccine-
related encephalopathy. See Ex. 103 at 1-2. Read in the context of the entire note, as well as the
note from July 23, 2002,12 the pediatrician clearly questioned only whether the child’s fever was
a reaction to the vaccine. Nothing in the notes suggests that the fever was a symptom of
encephalopathy.13 Dr. Ashley did not diagnose C.A.P. with encephalopathy at that visit, or at
any other visit.
Petitioners also assert that Dr. Ashley used the words “weak” or “lethargic” to describe
C.A.P. on July 24, 2002. See Ex. 103 at 2; Ex. 106 at 3; Ex. 107 at 2. However, I do not see a
word that looks like “weak” in the handwritten note, nor do I see the word “lethargic.” See Ex.
34 at 37. And even if Dr. Ashley had described C.A.P. as “weak”, weakness is not synonymous
with lethargy. Lethargy is defined as “a lowered level of consciousness marked by listlessness,
drowsiness, and apathy.” Dorland’s at 1025. When C.A.P. presented to the pediatrician for
follow-up the next day, the pediatrician described him as “happy,” “playful,” in no acute distress,
and “well hydrated.” Ex. 10 at 4. These descriptions are inconsistent with encephalopathy.
Thus, due to the discrepancies between the medical notes that were originally filed and the
transcribed notes, compounded by the lack of authentication, I find that Exhibit 106 is not a true
or accurate transcription of C.A.P.’s medical records.
The same problems apply to the “Medical History” submitted by petitioners as Exhibit
107. Like Exhibit 106, this exhibit appears to include additional history reported by C.A.P.’s
parents and family friends. Special Master Hastings’ Ruling has already considered and rejected
petitioners’ claims that “C.A.P. showed certain symptoms of an injury that his medical records
did not document.” Ex. 103 at 2. The Ruling specifically addressed the additional allegations
from family members, friends, and experts, and found C.A.P.’s medical records to be “more
reliable than the parental and friend narratives, made later in time, concerning his alleged post-
vaccination symptomatology.” Ruling at 32. I concur with Special Master Hastings and will not
replow that ground here.
12 The patient phone call note from the physician on July 23, 2002, states as follows: “Discussed
fevers in general [and] fever control. Also fever as a reaction to the immunization can last 24-36
hours [after] injection.” Ex. 10 at 14.
13 In the medical community, encephalopathy is typically defined as “any degenerative disease of
the brain.” Dorland’s at 614; see also Ex. 99 at 3. The Vaccine Injury Table, however, defines
encephalopathy more narrowly. See infra Section VII.B. Dr. Ashley’s note does not suggest
signs and symptoms of encephalopathy using either definition.
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iii. Growth Chart
Petitioners assert that C.A.P. failed to gain weight after April 9, 2002, and that his lack of
weight gain was a symptom of failure to thrive, which caused a “lasting harmful effect on
C.A.P.’s brain development.” Ex. 103 at 2; see also Ex. 108.14 The contemporaneous medical
records, however, do not show that C.A.P. had failure to thrive. On February 5, 2002, the date of
C.A.P.’s two-month well-child visit and immunizations, his weight was 11 lb., 12 oz. Ex. 34 at
11. Although he had diarrhea and a stuffy nose, C.A.P. was noted to be a well baby, and his
developmental screen was normal. Ex. 34 at 15; Ex. 10 at 11. Similarly, on April 9, 2002, at his
four-month well-child visit, C.A.P. had a normal developmental screen, and was diagnosed as a
“well baby.” Ex. 34 at 15; Ex. 10 at 13. Four-month vaccinations were administered at that
time. Ex. 10 at 13. Three weeks later, C.A.P. presented for a sick visit, with a rash, cough, and
running nose. Ex. 34 at 35. He was diagnosed with an upper respiratory infection (“URI”) but
was noted to be “happy.” Id. C.A.P.’s pediatrician documented no concerns regarding his
weight.
C.A.P. was next seen by his pediatrician on July 22, 2002, at 7 months, for a well-child
visit. He was diagnosed a well child and received his immunizations. Ex. 10 at 14. The next
day, C.A.P.’s parents called the pediatrician to advise that C.A.P. had a fever of 102-103° F and
that he was fussy, but that he felt better when given Motrin. Id. The note specifically addressed
intake and noted that C.A.P. was “eating ok.” Id. There is no indication that C.A.P. was not
eating well or that he had failure to thrive.
Mrs. Prokopeas placed a second call to the pediatrician’s office on July 23, 2002, to again
report that C.A.P. had a fever of 102-103° F. Notes from this call stated that C.A.P. “was
playful” and had no symptoms other than fever. Ex. 10 at 15. The next day, C.A.P. was seen by
the pediatrician, who documented a fever as high as 103° F for two days and noted that C.A.P.
was described as “not himself,” but did not express concern about C.A.P.’s weight or mention
failure to thrive. Ex. 34 at 37. C.A.P.’s parents took him to another pediatrician, Dr. Porter, on
July 25, 2002. They reported that he had diarrhea and “could not keep anything down,” but he
was noted to be “happy,” “playful,” and “well hydrated.” Ex. 10 at 4. Dr. Porter diagnosed
C.A.P. with viral gastroenteritis, but he did not document anything about failure to thrive. Id.
Dr. Porter next saw C.A.P. for follow-up on August 14, 2002. Petitioners reported that C.A.P.
14 Exhibit 108 appears to be the weight portion of C.A.P.’s growth chart for birth through 12
months. However, growth charts should also include length-for-age and head circumference-for-
age data. Clinical Growth Charts, Nat’l Ctr. for Health Statistics, www.cdc.gov/growthcharts/
clinical_charts.htm (last visited Apr. 16, 2019). Infants (birth to 24 months) must be measured
for length, and the data documented on the sex-appropriate length-for-age chart. Id. “Growth
charts are not intended to be used as a sole diagnostic instrument. Instead, growth charts are
tools that contribute to forming an overall clinical impression of the child being measured.”
CDC Growth Charts: United States, Nat’l Ctr. for Health Statistics, www.cdc.gov/growthcharts/
background.htm (last visited Apr. 16, 2019).
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had a cough for three days and diarrhea for seven days. Id. Dr. Porter diagnosed C.A.P. with
thrush15 and feeding issues, prescribed gentian violet for thrush, and encouraged solid food. Id.
C.A.P. was next seen for his nine-month well-child visit. He was noted to be crawling
and standing with assistance. Ex. 10 at 3. Dr. Porter diagnosed C.A.P. as a well child, making
no reference to failure to thrive, and administered a Hep B vaccination. Id. Approximately one
week later, on September 30, 2002, C.A.P. presented with congestion, runny nose, and vomiting.
Id. He was noted to be teething, but his appetite was normal (“app ok”). Id. Physical
examination revealed that C.A.P. was alert and cooperative. Id. Dr. Porter diagnosed C.A.P.
with a viral URI and a feeding problem, but he did not diagnose him with failure to thrive. Id.
On October 13, 2002, C.A.P. was taken to the ER with vomiting and diarrhea. Ex. 35 at
16-19. His weight at the time was 8.35 kg, or approximately 18.4 lb. Id.; Ex. 108. C.A.P. was
diagnosed with gastroenteritis, but not failure to thrive.16 Ex. 35 at 19. After this ER visit, there
are no medical records for approximately one year. Once medical care resumes in 2003,
however, the records still do not reflect failure to thrive.
Based on the growth chart provided by petitioners, C.A.P.’s weight gain slowed in
September 2002. Ex. 108 at 1. This plateau, however, was short lived. Id. By October 13,
2002, C.A.P. had gained a pound. Id. Subsequently, C.A.P.’s weight continued to increase. Id.
He weighed 21.7 lb. on June 5, 2003; 26 lb. on January 6, 2004; and 30 lb. on May 14, 2005. Id.
By June 5, 2012, his weight placed him in the 80th percentile as reported by the CDC. Id. The
last measurement reported by petitioners for C.A.P., taken when he was nearly 16 years old, is
170 lb., placing him in the 90th percentile. Id.
In short, no treating physician noted or suggested that C.A.P. had failure to thrive, and no
physician documented any concerns about his weight. I thus find no basis to conclude that
Special Master Hastings’ Ruling was inaccurate based on petitioners’ argument about weight
loss or failure to thrive.
iv. MITOswab Test and Mitochondrial DNA Test Results
On September 20, 2018, petitioners filed C.A.P.’s MITOswab test results from December
2017. Ex. 115. The report does not appear to be signed or dated by any physician or laboratory
director. The results purport to show that the “overall content of mitochondria is in the normal
range” but that there are significant deficiencies in the activity of respiratory chain complex I and
IV. Id. at 1-2. Notably, the report includes a caveat that “the buccal mitochondrial enzyme
testing approach is still a work in continued improvisations. While the published data supports
the evidence for the representation of skeletal muscle . . . RC enzymes activities by buccal tissue
. . . , more work is needed to be undertaken to have a more conclusive statement.” Id. at 2. The
15 Thrush is defined as “candidiasis of the oral mucosa, usually the buccal mucosa and tongue,
and sometimes the palate, gingivae, and floor of the mouth.” Dorland’s at 1924.
16 Gastroenteritis is defined as “inflammation of the lining of the stomach and intestines,
characterized by anorexia, nausea, diarrhea, abdominal pain, and weakness.” Dorland’s at 764.
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report also contains a disclaimer: “Please note that this MITOswab test is a lab developed test . . .
and not yet approved by FDA.” Id. After filing this study, petitioners requested “additional time
to investigate the question of what role mitochondrial dysfunction may have played in the cause
of [C.A.P.’s] disabilities.” Pet. Response to Mot. for Ruling on the Record (“Pet. Response”)
(ECF No. 174) at 3. According to petitioners, their experts recommended that C.A.P. have a
“mitochondrial DNA test” to determine whether he had a mitochondrial disorder. Id. at 4.
C.A.P.’s mitochondrial DNA test was performed and returned a normal result. Ex. 119 at
1. The report states as follows:
Mitochondrial DNA sequencing and deletion analysis did not identify any clinically
significant variants. . . . This test result may be called “normal” or “negative”
because a genetic change that may explain [C.A.P.’s] medical and/or
developmental history was not found. All sequence variants reviewed were
classified based on the American College of Medical Genetics (ACMG) standards
and guidelines.
Id. The report was electronically signed by Peter L. Nagy, M.D., Ph.D., Laboratory Director,
and the methodology used is described in detail. Id. at 4. The report also contains the caveat that
the test has not been “cleared or approved” by the FDA, although the laboratory that performed
the test is certified under the Clinical Laboratory Improvement Amendments (“CLIA”).17 Id.
Petitioners sought mitochondrial DNA testing to determine whether C.A.P. had a
mitochondrial disorder, asserting that the test would be “highly relevant . . . in understanding the
symptoms which accompanied the high fever that [C.A.P.] suffered after his July 22, 2002
vaccinations . . . .” Pet. Response at 4-5. They described the DNA test as “the best available
evidence” on the issue of whether C.A.P. had a mitochondrial disorder. Id. at 5. The results,
however, do not provide evidence of a mitochondrial disorder. Therefore, I find no factual basis
to allow petitioners to continue pursuing this theory, through additional expert review or
otherwise.
v. Other Exhibits
The balance of petitioners’ exhibits includes a summary of C.A.P.’s various diagnoses
(Exhibit 109);18 an overview of autism (Exhibit 110); an overview of “Specific Learning
17 The Clinical Laboratory Improvement Amendments of 1988 are regulations which “include
federal standards applicable to all U.S. facilities or sites that test human specimens for health
assessment or to diagnose, prevent, or treat disease.” Clinical Laboratory Improvement
Amendments (CLIA), Ctrs. for Disease Control & Prevention, https://wwwn.cdc.gov/
clia/About.aspx (last visited Apr. 29, 2019).
18 The summary of diagnoses refers to exhibits previously filed as Exhibits 5 through 90, and is a
demonstrative exhibit. While it summarizes prior information, it does not provide new evidence.
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Disabilities” (Exhibit 111); a group of exhibits previously filed (Exhibit 112); and written
testimony by Mrs. Prokopeas (Exhibit 118).19
The overview regarding learning disabilities provides general information and
definitions. See generally Ex. 111. Based on this information, and C.A.P.’s school records,
C.A.P. meets the criteria for a learning disability. However, the information provided does not
explain the etiology or causes of C.A.P.’s specific learning disability. The records do not refer to
C.A.P.’s learning disability as an encephalopathy, nor do they describe any association between
C.A.P.’s learning disability and encephalopathy. Moreover, this exhibit does not reference
vaccines or associate vaccines with C.A.P.’s learning disability.
B. Request for Reconsideration of Special Master Hastings’ Ruling on the Basis
that C.A.P.’s Diagnosis is Encephalopathy Rather Than Autism
In their Statement of Position, petitioners assert that Special Master Hastings’ ruling was
based on a “‘causation-in-fact’ connection between vaccines and autism,” and that C.A.P. does
not have autism. Ex. 103 at 2-3. Petitioners, however, misinterpret Special Master Hastings’
Ruling. Throughout the Ruling, Special Master Hastings clearly states that “[p]etitioners allege
that C.A.P. suffered from an encephalopathy that was ‘caused-in-fact’ by the cumulative effects
of [his] vaccinations.” Ruling at 1; see also Ruling at 8 (“Petitioners filed an Amended Petition .
. . alleging that C.A.P. ‘developed encephalopathy from repeated exposures to mercury and other
vaccine ingredients.”); Ruling at 30-31 (summarizing Dr. Corbier’s opinion that C.A.P. had a
brain disorder described as static encephalopathy or chronic encephalopathy); Ruling at 45 n.40
(finding that C.A.P. did not suffer encephalopathy, a Table injury).
Special Master Hastings does refer to the fact that C.A.P. had been diagnosed with
autism, but petitioners concede this in Exhibit 109, in which they provide a chart with a “History
of Diagnoses for C.A.P. from birth to present.” See Ex. 109. Included in that list is the diagnosis
of PDD-NOS20 given by Dr. Bourland on July 22, 2004, which is an Autism Spectrum Disorder.
Id. Dr. Bourland’s records show that in November 2003, C.A.P.’s parents noted a substantial
change in his behavior. Ex. 9 at 1. After assessment, Dr. Bourland diagnosed C.A.P. with PDD-
NOS. Id. at 4. The diagnosis of Autism-PDD also appears in the medical records of Dr. Hamel
on July 19, 2004. Ex. 18 at 7. Later records indicate that C.A.P. no longer had the diagnosis of
autism, and his updated diagnosis was learning disability coupled with speech and language
delay. Ex. 47 at 22; Ex. 48 at 27 (“Past Diagnosis: Autism/PDD, Today’s Diagnosis: LD –
Learning Disability”); Ex. 56 at 45 (recommending in 2007 that C.A.P.’s school district
“consider eligibility of autism [to] be removed,” but also recommending “an eligibility of a
specific learning disability in the area of oral expression”). However, the records clearly indicate
that C.A.P. did have the diagnosis of autism and received special education services for that
19 Exhibit 118, entitled “Testimony from Ellena Prokopeas, July 30, 2014,” is a two-page
document that does not offer any new evidence.
20 PDD-NOS is Pervasive Developmental Disorder Not Otherwise Specified, an Autism
Spectrum Disorder (“ASD”). See Ruling at 4 n.2.
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diagnosis for a period of time. Thus, it was accurate for Special Master Hastings to refer to
C.A.P.’s autism diagnosis in his Ruling.
To the extent that petitioners request reconsideration of Special Master Hastings’ Ruling
based on his reference to C.A.P.’s autism diagnosis, that request is denied.
V. Expert Opinions
In support of their claim, petitioners offer the expert reports of Dr. Jean-Ronel Corbier,
Dr. Joseph Bellanti, and Dr. Brett Abrahams.21 See Exs. 87, 89, 96, 98, 99, 105, 116.
Respondent submits expert reports by Dr. Gerald Raymond and Dr. Judith Miller. See Exs. A,
H, L, T.
A. Petitioners’ Expert, Dr. Joseph Bellanti, M.D.22
Dr. Bellanti opined that C.A.P. had repeated allergic reactions to some component in the
vaccines that he received in 2002, causing him to be diagnosed with “static encephalopathy” two
years later in 2004.23 Ex. 87 at 3. As explained by Special Master Hastings, the factual
predicates upon which Dr. Bellanti based his expert opinions, taken in part from petitioners’ joint
affidavit and from the medical history documented by Dr. Kotsanis (which was, in turn, taken
from the parents), are inconsistent with the facts set forth in C.A.P.s’ contemporaneous medical
records. Ruling at 44; see also Ex. 87. For all the reasons discussed in the Ruling, I agree with
Special Master Hastings, who rejected the parents’ affidavit testimony, written and oral
statements, and testimony regarding C.A.P.’s post-vaccination symptoms. I also reject the
medical history documented by Dr. Kotsanis for the same reasons – that it was not based on the
contemporaneous records of C.A.P.’s pediatrician. See Ex. 5 at 2-3.
As for causal theories, Dr. Bellanti initially hypothesized that C.A.P. might have an
abnormal de novo genetic mutation of chromosome 21, which made him susceptible to autism.24
21 Much of the medical literature cited in petitioners’ expert reports was not filed. See, e.g., Ex.
89 at 3; Ex. 96 at 4-5; Ex. 105 at 5; Ex. 116 at 2. On April 25, 2019, the undersigned ordered
petitioners to file all outstanding medical literature by May 16, 2019. Order dated Apr. 25, 2019
(ECF No. 183). Petitioners did not comply.
22 Dr. Bellanti’s qualifications are described in Special Master Hastings’ Ruling and will not be
restated here. See Ruling at 28-29.
23 Dr. Bellanti references several different diagnoses in his expert reports, including ASD, static
encephalopathy, injury of the nervous system, and mental retardation. See Ex. 87 at 3; Ex. 89 at
3.
24 Dr. Bellanti’s reference is to genetic studies conducted on July 12, 2007, and filed on May 19,
2009, which showed “[a]bnormal hybridization pattern for 21q subtelomere probe.” See Ex. 25
at 8.
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Ex. 89 at 2. Citing an article by Molloy,25 Dr. Bellanti questioned whether C.A.P. had a genetic
risk factor, and if so, the significance of such a risk factor. Ex. 87 at 3. However, in his
supplemental report, Dr. Bellanti concludes that the significance of the defect in C.A.P.’s
chromosome 21 was “not entirely clear.” Ex. 89 at 2. He also observes that a follow-up study to
Molloy, published by Parr, et al., did not confirm Molloy’s findings. See id. at 1. Thus, Dr.
Bellanti is unable to determine the significance of C.A.P.’s chromosomal abnormality, other than
to say that it has been associated with “various forms of mental retardation and could have
contributed to the injury caused by the vaccines.” Id. at 2.
As another “medical theory of causation,” Dr. Bellanti asserts that “there is a documented
literature supporting a relation between vaccines and immunologically-mediated injury of the
nervous system and mental retardation.” Ex. 89 at 3. Dr. Bellanti does not explain what he
means by “immunologically-mediated injury.” He does not describe the mechanism, nor does he
offer any explanation of how it caused injury. He references four articles,26 but they all relate to
the abnormality in chromosome 21 and its association with developmental regression and/or
mental retardation. They do not appear to explore potential associations between vaccines and
injury of the nervous system, vaccines and mental retardation, or vaccines and encephalopathy or
static encephalopathy.
In a similarly conclusory fashion, Dr. Bellanti asserts that there was a “logical sequence
of cause and effect” due to the “striking history of a well child then sustaining fever, high pitched
cry and developmental abnormalities.” Ex. 89 at 3. Dr. Bellanti does not state any facts from
C.A.P.’s contemporaneous medical records in support of this conclusion. Again, this conclusion
is based upon Dr. Bellanti’s misassumption of facts which I have specifically rejected and found,
as did Special Master Hastings, to be clearly erroneous. See Ruling at 44-45.
As for Althen Prong Three, Dr. Bellanti asserts that the “onset of serious developmental
abnormalities in timing with the receipt of the vaccines supports a temporal relationship.” Ex. 89
at 3. Dr. Bellanti did not explain what temporal relationship would be expected given his
proposed theory of immunologically-mediated injury. Specifically, he did not explain how or
why the temporal association was appropriate when the records showed that the vaccinations at
issue were administered in 2002, but C.A.P was not diagnosed with encephalopathy until 2004.27
25 In Molloy, the authors reported that genetic elements in certain regions of chromosomes 21
and 7 “are likely to confer susceptibility to autism or modify the disease presentation in a
subgroup of children characterized by a history of developmental regression.” Ex. 87 at 4.
26 Specifically, Dr. Bellanti references articles from Molloy, et al. (“Evidence for linkage on 21q
and 7q in a subset of autism characterized by developmental regression”); Parr, et al. (“Response
to paper by Molloy et al.: linkage on 21q and 7q in autism subset with regression”); Ozkinay, et
al. (“Prenatal diagnosis of de novo unbalanced translocation 8p;21q using subtelomeric probes”);
and Kok, et al. (“Application of a comprehensive subtelomere array in clinical diagnosis of
mental retardation”). See Ex. 89 at 3.
27 The first time that C.A.P. was suspected to have encephalopathy was November 8, 2004, when
Dr. Tardo suggested that he suffered from “static encephalopathy.” See Ex. 75 at 3; Ex. 109 at 1.
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With regard to diagnosis, Dr. Bellanti refers to C.A.P.’s injury as autism spectrum
disorder and static encephalopathy. Ex. 87 at 2-3. Dr. Bellanti defines autism in his second
report as “a pervasive development disorder with a genetic component.” Ex. 89 at 1. He also
describes C.A.P. as having “neurological and developmental abnormalities” and “mental
retardation.” Id. at 2-3.
B. Petitioners’ Expert, Dr. Jean-Ronel Corbier, M.D.28
Dr. Corbier filed four expert reports, with inconsistent diagnoses and differing medical
theories. See Exs. 98, 99, 105, 116. Dr. Corbier’s reports are somewhat difficult to follow, but
he appears to propose six causal mechanisms.
In his first report, Dr. Corbier states: “For the purpose of this report, I would like to
specifically mention possible triggers that relate to [C.A.P.].” Ex. 98 at 1 (emphasis added). He
then maintains that “[i]t is well known that environmental triggers play an important role in the
development of neurological disorders.” Id. He asserts that vaccines are among these
environmental factors, and that “the strong association of immunization and neurological
regression has been undeniable for many clinicians and families.” Id. However, Dr. Corbier
does not explain how these possible environmental triggers cause injury that manifests as a
learning disorder or encephalopathy. See id.
Next, Dr. Corbier seems to propose a theory based on preservatives and/or adjuvants in
the vaccines at issue. Ex. 105 at 5. He alleges that immunological changes occurred “perhaps”
due to adjuvants in the DTaP vaccine. Id. Dr. Corbier mentions ASIA
(autoimmune/inflammatory syndrome induced by adjuvants), or Shoenfeld’s syndrome, but he
does not describe how the syndrome applies in this case. Id. He also briefly references “immune
activation,” presumably in the context of adjuvants. Id. Dr. Corbier offers no analysis or
evidence to support these references.
Dr. Corbier’s third theory focuses on the pertussis portion of the DTaP vaccine. He
opines that the DTaP vaccine administered to C.A.P. on July 22, 2002, caused a Table
encephalopathy “within a day of his vaccinations.”29 Ex. 99 at 4-5. He bases this opinion on
allegations that C.A.P. was “lethargic, lifeless and febrile within 72 hours” of the vaccination.
Id. at 5. Dr. Corbier further opines that C.A.P. had “chronic encephalopathy” characterized by
“dysfunction in his cognitive and social skills.” Id. Dr. Corbier does not explain how the DTaP
vaccine caused this injury.
Dr. Usman later diagnosed C.A.P. with “toxic encephalopathy” on December 13, 2004. See Ex.
23 at 2; Ex. 109 at 1.
28 Dr. Corbier’s qualifications are described in Special Master Hastings’ Ruling and will not be
restated here. See Ruling at 30.
29 Dr. Corbier’s theory that C.A.P. had a Table encephalopathy is discussed in more detail below,
in Section VII.C.
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The next theory is very similar to the third theory. Dr. Corbier states that “after multiple
vaccines on 2/5/2002, 4/9/2002, 7/22/2002 and 9/24/2002, [C.A.P.] developed symptoms of
Vaccine Induced Encephalitis,30 an inflammation of the brain caused by vaccines.” Ex. 98 at 3.
This theory is not well developed, but it appears to be a variation on Dr. Corbier’s opinion that
C.A.P. had a Table encephalopathy. See id.
Dr. Corbier’s fifth theory relates to mitochondrial dysfunction31 and its association with
neurological disorders. Ex. 98 at 2; Ex. 116. However, C.A.P. has not been diagnosed with a
mitochondrial disorder or dysfunction, and no references in the medical records suggest that he
was ever so diagnosed. C.A.P.’s mitochondrial DNA genetic testing returned normal results and
therefore provides no support for Dr. Corbier’s theory.
As for Dr. Corbier’s sixth theory, he alleges an association between autistic regression
and an underlying mitochondrial disorder, suggesting that C.A.P. had “an abnormal immune
activation with a high fever leading to increased oxidative stress and a regressive
encephalopathy.” Ex. 116 at 2. Dr. Corbier opines that “C.A.P. got sick immediately after 7-22-
02 vaccination then regressed. The regressive encephalopathy, among other things are
characterized by C.A.P.’s acquired speech impairment and learning disability.” Id. These
conclusions, however, are based on facts specifically rejected by Special Master Hastings in his
Ruling:
I reject the Petitioners’ allegation that shortly after his vaccinations of July 22,
2002, C.A.P. had uncontrollable screaming and crying, and failed to nurse. I reject
that C.A.P.’s sleeping difficulties began soon after his vaccinations of July 22,
2002. I also reject Petitioners’ allegations that C.A.P.’s lack of eye contact began
in the time period immediately after his vaccinations of July 22, 2002. Further, I
credit the notation in the record of the second phone call of July 23, 2002, that
C.A.P. was “playful,” and that he had no additional symptoms at that time other
than his fever.
Ruling at 43 (emphasis omitted). Additionally, Special Master Hasting ruled that Dr. Corbier
relied on misassumptions of fact in concluding that “soon after his vaccinations of July 22, 2002,
C.A.P. became ‘lifeless’ and ‘lethargic,’ and was ‘crying inconsolably.’” Ruling at 45. I concur.
Dr. Corbier also asserts that C.A.P. had “failure to thrive,” but it is not clear whether this
constitutes a separate theory of causation. See Ex. 105 at 3. Regardless, he failed to cite to any
medical records demonstrating that C.A.P. was ever given that diagnosis. See id. To the extent
that failure to thrive is a theory of causation, Dr. Corbier failed to describe any mechanism or
30 Encephalitis is defined as “inflammation of the brain.” Dorland’s at 612.
31 Dr. Corbier references Dr. Richard Frye’s association of mitochondrial dysfunction and
neurological disorders. Ex. 98 at 2. Other special masters have thoroughly documented their
concerns with Dr. Frye’s theories. See, e.g., Bast v. Sec’y of Health & Human Servs., No. 01-
565V, 2012 WL 6858040, at *28 (Fed. Cl. Spec. Mstr. Dec. 20, 2012) (“Dr. Frye’s proposed
theory of causation is not supported by sound and reliance science.”), mot. for rev. denied, 117
Fed. Cl. 104 (2014).
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theory as to how vaccines cause failure to thrive or how vaccine-induced failure to thrive causes
encephalopathy. Moreover, I find no evidence in the medical records to support the notion that
C.A.P. had failure to thrive.
With regard to diagnosis, Dr. Corbier denies that C.A.P. was autistic. Ex. 105 at 2.
Instead, he alternatively opines that C.A.P. suffered from “regressive symptoms,” “hypotonia,”
“failure to thrive,” “encephalitis,” “static encephalopathy,” “chronic encephalopathy,” “Table
encephalopathy,” “regressive encephalopathy,” and “parenchymal brain disease.” See Exs. 98,
105, 116. Dr. Corbier defines encephalitis as “inflammation of the brain,” and he defines static
encephalopathy as “permanent or unchanging brain damage” due to “injury, damage, defect, or
illness” that interferes with “normal function, development, or learning.” Ex. 98 at 4; Ex. 99 at
3. He does not provide any further explanation of these diagnoses, nor does he describe the
relevant signs and symptoms, diagnostic studies, clinical course, or prognosis for these
conditions. He asserts that symptoms of static encephalopathy may be varied and unique,
depending on the severity of the injury and the area of brain affected. Ex. 99 at 4. Dr. Corbier
explains that if the damage “is in the part of the brain that controls speech and language, [the]
child might be delayed in learning to talk or to understand” what is said to him. Id. If, however,
the damage is more diffuse and widespread, the child may have cerebral palsy, learning
problems, mental retardation, or seizures. Id.
C. Petitioners’ Expert, Dr. Brett Abrahams, Ph.D.
Dr. Abrahams earned his Ph.D. in neuroscience from the University of British Columbia
and completed a postdoctoral fellowship at UCLA, where he received a postdoctoral scholar
award from the UCLA Brain Research Institute. Ex. 97 at 3. Over the course of his career, he
has authored or coauthored twenty-eight peer-reviewed articles and six book chapters/review
articles. Id. at 5-6. He now serves as director of the Laboratory of Autism Genetics and as an
assistant professor in the Departments of Neuroscience and Genetics at the Albert Einstein
College of Medicine. Id. at 2. Dr. Abrahams also actively consults on biotechnology matters,
such as the launch of a commercial test for the assessment of autism risk. Id. at 1-3.
In his expert report, Dr. Abrahams focuses on the DNA variation at 15q11.2, the initial
genetic mutation found in C.A.P., and its association with an increased risk for autism. See
generally Ex. 96. Dr. Abrahams concluded that there was no strong support for the notion that
duplication of genetic material associated with this genetic variation increases the risk of autism.
Id. at 3.32
32 C.A.P. was twice screened for chromosomal abnormalities. In 2004, chromosomal microarray
analysis revealed a duplication of two clones on chromosome 15q. Ex. 75 at 12. Later, in 2007,
tests showed a duplication of the subtelomere probe for chromosome 21q. Ex. 25 at 8. None of
parties’ experts consider these abnormalities dispositive. Although Dr. Bellanti notes that “major
defects in chromosome 21 have been associated with severe forms of mental retardation,” he
emphasized that studies of potential links between such chromosomal abnormalities and autism
had been inconclusive. Ex. 89 at 1-2 (concluding that “the significance of the chromosomal
abnormality is not entirely clear”). Dr. Raymond observes that “[t]here are limits to definitive
statements regarding the magnitude of the respective alterations since neither one [has been]
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D. Respondent’s Expert, Dr. Gerald V. Raymond, M.D.
Dr. Raymond, a neurologist and clinical geneticist, received his M.D. from the University
of Connecticut and served as a resident in neurology at Massachusetts General Hospital. Ex. T at
1-2. Subsequently, he completed a fellowship in developmental neuropathology at the
Universite Catholique de Louvain (Brussels, Belgium), and a fellowship in genetics and
teratology at Massachusetts General Hospital. Id. Dr. Raymond has authored or coauthored
over one-hundred peer-reviewed articles. Id. at 3-10. He has also authored and coauthored a
variety of other publications, including book chapters and editorials. Id. at 12-14. Currently, he
serves as a professor of pediatrics and neurology at the Penn State College of Medicine and as an
adjunct professor of neurology at the University of Minnesota. Id. at 1. His curriculum vitae
also documents his considerable experience in classroom and clinical instruction. Id. at 14-15.
Dr. Raymond is certified by the American Board of Medical Genetics and the American Board
of Psychiatry and Neurology, with special competency in child neurology. Id. at 16.
Dr. Raymond rejects Dr. Corbier’s references to the causal theory of ASIA, or vaccine
adjuvant-induced injury, as these mechanisms are controversial and C.A.P. did not demonstrate
any “immunologic changes” attributable to these conditions or theories. Ex. U at 2. Dr.
Raymond similarly disagrees with Dr. Corbier that C.A.P. had an altered mental status, signs and
symptoms of encephalopathy, neurological regression, encephalitis, or brain inflammation at any
time following vaccination. Ex. L at 3. Specifically, Dr. Raymond disputes Dr. Corbier’s
conclusion that C.A.P. was irritable and lethargic, since these signs and symptoms were absent
from the contemporaneous medical records. Id. In summary, Dr. Raymond opined that there
was “no evidence of an adverse reaction to any of the immunizations received and definitely no
findings of an acute encephalopathy or injury to the brain from [C.A.P.’s] vaccinations.” Ex. U
at 3.
Dr. Raymond also disagrees that C.A.P. had a mitochondrial disease or disorder. He
notes that the alleged association between mitochondrial dysfunction and autism is controversial,
supported by “little evidence” of causation. Ex. L at 2. Regardless, Dr. Raymond opines that
there is no evidence that C.A.P. has a mitochondrial disorder. Id. Dr. Raymond also rejects the
notion that C.A.P. had “failure to thrive” associated with vaccines. Ex. U at 2. Dr. Raymond
agrees that a child’s weight can reflect feeding problems, but he disagrees that feeding problems
suggest encephalopathy. Id.
With regard to diagnosis, Dr. Raymond provides a thorough summary of C.A.P.’s
medical history and concludes that C.A.P. was diagnosed with “intellectual disability [and]
receptive and expressive language issues,” coupled with social and behavioral problems in early
life which “placed him on the autistic spectrum.” Ex. A at 3. Raymond further opines that no
adequately evaluated,” but also states that “[t]here is no evidence that the chromosomal
abnormalities found in this child makes him susceptible to a vaccine-related event.” Ex. A at 6-
7; see also Ex. L at 2. And Dr. Abrahams opines that the “assertion that increased gene dosage
across this specific portion of Chromosome 15 increases risk of autism in any meaningful way”
is “untenable.” Ex. 96 at 1. Thus, these abnormalities do not factor into my causation analysis.
Note also that these tests are distinct from the test results filed on February 5, 2019, which
involved mitochondrial DNA sequencing and deletion analysis. See Ex. 119.
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“contemporaneous adverse events” were associated with C.A.P.’s childhood vaccinations, and in
fact, that the medical records consistently describe him as a “happy, awake, and alert baby.” Id.
With respect to petitioners’ allegations of encephalopathy, Dr. Raymond opines that C.A.P.’s
medical records contain no reports of any such adverse effects following his two-month and
four-month vaccinations. Id. Dr. Raymond thus concludes that C.A.P. never had acute
encephalopathy. Id.
E. Respondent’s Expert, Dr. Judith Miller, Ph.D., Licensed Psychologist
Dr. Miller earned her Ph.D. in clinical child and family psychology from the University
of Utah. Ex. I at 1. She subsequently served as a psychology fellow at the Primary Children’s
Medical Center at the University of Utah School of Medicine, and as a postdoctoral fellow at the
Emory Autism Resource Center at the Emory School of Medicine. Id. She has coauthored
thirty-seven peer-reviewed publications, as well as a number of reviews, editorials, and book
chapters. Id. at 6-12. Over the course of her career, Dr. Miller has taken on substantial academic
and teaching responsibilities at a number of institutions, including the University of Utah and the
University of Pennsylvania. Id. at 3-4. She now serves as a senior scientist, among other roles,
at the Center for Autism Research at the Children’s Hospital of Philadelphia. Id. at 1.
Dr. Miller’s opinions generally pertain to the onset of C.A.P.’s autism-related diagnoses.
She reviewed C.A.P.’s medical and educational records and notes that “the first documented
signs of an autism spectrum disorder” occurred when he was 22 months old, when his parents
shared their concerns with Dr. Kotsanis. Ex. H at 7. Unfortunately, she observes, no medical
records between the ages of approximately 10 to 22 months of age were provided. Id. Dr. Miller
notes that the lack of records from this time period “suggests that family did not seek clinical
care for any particular concerns.” Id. at 8. She contrasts the paucity of medical records before
the age of 22 months to the many records evidencing the frequent treatment petitioners sought
for C.A.P. after the age of 22 months. Id. Based on this change in parental behavior, she
believes that that his parents’ concerns “crystallized” when C.A.P. was 22 months old. Id. Thus,
she concludes that C.A.P. had an ASD in October 2003, when he was seen by Dr. Kotsanis. Id.
While Dr. Miller agrees that it is “possible that early, nonspecific signs of [C.A.P.’s] autism”
may have been present earlier, she does not believe that they had “risen to a level of concern . . .
due to wide variations in early childhood development and limited understanding of early signs
of autism during the years [C.A.P.] was a toddler.” Id. at 9.
VI. Issues
The parties dispute the following causation issues:
• Whether the DTaP vaccine administered to C.A.P. on July 22, 2002, caused him
to suffer an encephalopathy as defined by the Vaccine Injury Table, 42 C.F.R.
§ 100.3(b)(2) (2004). See Ex. 103 at 3.
• Whether any of the vaccines C.A.P. received in 2002 resulted in encephalopathy
based on a causation-in-fact theory.
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• Whether the “vaccinations C.A.P. received on July 22, 2002, significantly
aggravated an underlying mitochondrial disorder, which . . . manifested as a
regressive encephalopathy with features of a learning disability.” See Ex. 117 at
13.
VII. Discussion
A. Resolution of Case Without Hearing
I opted to determine entitlement in this case based on written submissions and evidentiary
filings, including the expert reports filed by each side. The Vaccine Act and Rules not only
contemplate but encourage special masters to decide petitions on papers rather than via
evidentiary hearing, when (in the exercise of their discretion) they conclude that the former
means of adjudication will properly and fairly resolve the case. § 12(d)(2)(D); Vaccine Rule
8(d). The choice to do so has been affirmed on appeal. See Hooker v. Sec’y of Health & Human
Servs., No. 02-472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing
numerous cases where special masters decided on the papers in lieu of a hearing). A hearing is
not required in every matter, regardless of the parties’ preferences. See Hovey v. Sec’y of Health
& Human Servs., 38 Fed. Cl. 397, 400-01 (1997) (determining that the special master acted
within his discretion in denying evidentiary hearing), appeal dismissed, 135 F.3d 773 (Fed. Cir.
1997); Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993); Murphy v.
Sec’y of Health & Human Servs., No. 90-882V, 1991 WL 71500, at *2 (Ct. Cl. Spec. Mstr. Apr.
19, 1991), mot. for rev. denied, 23 Cl. Ct. 726 (1991), aff’d, 968 F.2d 1226 (Fed. Cir. 1992).
A hearing provides a petitioner with the opportunity to present live testimony, which aids
the special master most in cases where witness credibility is at issue, or where there is a need to
pose questions to a witness in order to obtain information not contained in, or not self-evident
from, the existing filings. See, e.g., Hooker, 2016 WL 3456435, at *21 (discussing the factors
that weigh against holding a hearing); Murphy, 1991 WL 71500, at *2 (finding no justification
for a hearing where “the claim is fully developed in the written record and the special master
sees no need to observe the fact witnesses personally for the purpose of assessing credibility).
Prior decisions have recognized that a special master’s discretion in deciding whether to conduct
an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to afford each party “a
full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 401. But that rule also
includes the obligation to create a record “sufficient to allow review of the special master’s
decision.” Id. Thus, the fact that a claim is legitimately disputed, such that the special master
must exercise her intellectual faculties in order to decide a matter, is not itself grounds for a trial.
Special masters are expressly empowered to resolve fact disputes without a hearing, and they
may do so if the record at issue has been sufficiently developed to determine that each side’s
“full and fair” opportunity has not been abridged.
In this case, live witness testimony was not required in order for me to reach a reasoned
decision on entitlement. Thanks in part to the fact hearing held by Special Master Hastings in
August 2016, the record itself was expansive and contained sufficient evidence upon which to
base this decision. The flaws in petitioners’ theory and factual arguments were self-evident from
review of the medical records and the expert reports submitted, which relied heavily on
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speculative assertions and statements unsupported by the contemporaneous medical record or by
reliable scientific evidence. I simply do not require additional oral testimony to decide the case.
Ultimately, the most significant issue in deciding whether to hold a hearing is whether the refusal
to do so will deprive the claimants of the fair opportunity to prosecute their case. Petitioners
have received such an opportunity here. Therefore, these circumstances counsel in favor of
resolving the matter on the papers.
B. Applicable Legal Standards
The Vaccine Act established the Program to compensate vaccine-related injuries and
deaths. § 10(a). “Congress designed the Vaccine Program to supplement the state law civil tort
system as a simple, fair and expeditious means for compensating vaccine-related injured persons.
The Program was established to award ‘vaccine-injured persons quickly, easily, and with
certainty and generosity.’” Rooks v. Sec’y of Health & Human Servs., 35 Fed. Cl. 1, 7 (1996)
(quoting H.R. Rep. No. 908 at 3 (1986), as reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
To receive compensation under the Program, petitioners must prove either: (1) that
C.A.P. suffered a “Table injury” — i.e., an injury listed on the Vaccine Injury Table —
corresponding to a vaccine that he received, or (2) that C.A.P. suffered an injury that was
actually caused by the vaccines he received. See §§ 11(c)(1), 13(a)(1)(A); Capizzano v. Sec’y of
Health & Human Servs., 440 F.3d 1317, 1319-20 (Fed. Cir. 2006).
The Vaccine Injury Table33 includes an injury of encephalopathy occurring within 72
hours of a vaccine containing certain pertussis bacteria or antigens. The Qualifications and Aids
to Interpretation (“QAI”) section of the Table provides that “a vaccine recipient shall be
considered to have suffered an encephalopathy only if such recipient manifests, within the
applicable period, . . . an acute encephalopathy, and then a chronic encephalopathy . . . for more
than 6 months beyond the date of vaccination.”34 42 C.F.R. § 100.3(b)(2). For children 18
months of age or younger, acute encephalopathy requires a “significantly decreased level of
consciousness35 lasting for at least 24 hours.” Id. § 100.3(b)(2)(i)(A).
33 Citations are to the version of the Table in effect on November 29, 2004, when this petition
was filed. See 42 C.F.R. § 100.3 (2004); Revisions and Additions to the Vaccine Injury Table,
67 Fed. Reg. 48,558 (July 25, 2002) (to be codified at 42 C.F.R. pt. 100.3). Although revisions
to the Table in 2017 made minor alterations to the definition of encephalopathy, and added a
definition of encephalitis, these amendments do not impact this case. See Revisions to the
Vaccine Injury Table, 82 Fed. Reg. 6,294 (Jan. 19, 2017) (to be codified at 42 C.F.R. pt. 100.3)
(noting that changes to the Table “apply only to petitions for compensation under the VICP filed
after this final rule becomes effective”).
34 A chronic encephalopathy exists if the change in mental status that began with the acute
encephalopathy persists for at least six months. 42 C.F.R. § 100.3(b)(2)(ii).
35 A “significantly decreased level of consciousness” is indicated by the presence of one or more
of the following signs: “(1) Decreased or absent response to environment (responds, if at all,
only to loud voice or painful stimuli); (2) Decreased or absent eye contact (does not fix gaze
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In the wake of the OAP proceedings, some petitioners continued to pursue their cases by
characterizing their children’s injuries as “encephalopathy” accompanied by developmental
delay rather than autism. See Fester v. Sec’y of Health & Human Servs., No. 10-243V, 2013 WL
5367670, at *1 n.5 (Fed. Cl. Spec. Mstr. Aug. 27, 2013). Such petitioners often chose to amend
their theories “based on a belief that claims alleging autism [would] not be compensated, but that
claims alleging these other conditions may be compensated.” Id. However, “recharacterizing a
condition as an ‘encephalopathy’ — a term that can encompass conditions ranging from
intoxication to a coma — when another diagnosis is more specific and appropriate does little to
advance a vaccine injury claim.” Id.; see also Ruling at 7 n.4 (discussing two cases where
vaccinees who suffered from autism also alleged Table injuries and differentiating those claims
from petitioners’ claim).
C. Alleged Table Injuries
Petitioners ask that C.A.P.’s claim be considered a Table injury, alleging that the DTaP
vaccine administered to C.A.P. on July 22, 2002, caused encephalopathy. Am. Petition at 2-3.
Petitioners also assert that DTaP vaccines given February 5, 2002, and April 9, 2002, mark the
initial starting point of C.A.P.’s developmental delay, and that his failure to thrive, speech
impairment, and learning disability are manifestations of his Table encephalopathy. Id.
Petitioners identify four reasons that the evidence supports a finding of Table encephalopathy:
C.A.P.’s symptoms following vaccination; petitioners’ efforts to address C.A.P.’s symptoms; the
response by C.A.P.’s pediatrician; and petitioners’ expert reports. Ex. 103 at 1-2; 2018
Amendment at 19.
Although this claim was initially based on the diagnosis of autism, petitioners’ 2011
amended petition reframed their claim based on the diagnosis of encephalopathy. Dr. Corbier
affirmatively opines that C.A.P. does not have autism, but his most recent report seems to
conflate autism with speech impairment and learning disability. See Ex. 116 at 2. For instance,
Dr. Corbier suggests that C.A.P has an “underlying susceptibility” caused by “impairment of
mitochondrial function,” which caused “regressive encephalopathy.” Id. at 1-2. He does not
define “regressive encephalopathy,” but uses the phrase in the context of the Shoffner study on
“autistic regression” and the Poling study on “Developmental Regression . . . in a child with
Autism.”36 Id. at 2. These references to autism seem misplaced, since petitioners deny that
C.A.P. has or ever had autism, and Dr. Corbier fails to explain how autism relates to C.A.P.’s
speech impairment and learning disability.
upon family members or other individuals); or (3) Inconsistent or absent responses to external
stimuli (does not recognize familiar people or things).” 42 C.F.R. § 100.3(b)(2)(i)(D).
36 The author of the Poling case study was also the father of the study’s subject, and the Poling
family had a pending claim in this Program. This history was more fully addressed by former
Chief Special Master Vowell in a ruling on a motion for discovery in another matter. See R.K. v.
Sec’y of Health & Human Servs., No. 03-632V, 2015 WL 10911950, at *15-17 (Fed. Cl. Spec.
Mstr. May 23, 2016), mot. for rev. denied, 125 Fed. Cl. 57 (2016). Neither the familial
relationship nor the pending claim for compensation had been disclosed. Id. at 16.
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Ultimately, I do not accept petitioners’ allegation that C.A.P. suffered a Table
encephalopathy. As former Chief Special Master Campbell-Smith noted in Waddell v. Sec’y of
Health & Human Servs., the symptoms of a Table encephalopathy are “neither subtle nor
insidious.” No. 10-316V, 2012 WL 4829291, at *6 (Fed. Cl. Spec. Mstr. Sept. 19, 2012).
Petitioners assert that Dr. Porter’s records demonstrate that the onset of C.A.P.’s acute
encephalopathy was July 24, 2002, two days after the DTaP vaccine administered on July 22,
2002. See Ex. 103 at 2; Ex. 105. However, neither Dr. Porter’s notes, nor Dr. Corbier’s report,
provide any foundation for such a finding. C.A.P.’s post-vaccination medical records,
documented by two different pediatricians, show the following:
Date Event Citation
July 22, 2002 Physical Exam by Pediatrician Ex. 34 at 36
• Normal neurological exam
(mental status,
development, language)
• Diagnosis: well child
July 23, 2002 Phone Call from Chris Prokopeas Ex. 34 at 36
• Temperature of 102-103° F
• Reported that C.A.P. was
fussy, but felt better with
Motrin
July 23, 2002 Phone Call from Ellena Prokopeas Ex. 34 at 37
• Temperature of 102-103° F
• Reported that C.A.P. was
playful, with no other
symptoms
July 24, 2002 Physical Exam by Pediatrician Ex. 34 at 37
• Temperature of 103° F
• “[N]ot himself”
• Neck supple
• Chest clear
July 25, 2002 Physical Exam by Pediatrician Ex. 10 at 4
• Diarrhea
• Decreased appetite;
“[c]an’t keep anything
down”
• Fussy
• Happy, playful, no acute
distress
While C.A.P. may have had a febrile reaction to the vaccines administered on July 22,
these daily observations of his mental status show a baby who is alternatingly described as fussy
but happy and playful, and in no acute distress. Nothing in C.A.P.’s July 2002 records indicates
that he had a “significantly decreased level of consciousness” lasting 24 hours, as required for
Table encephalopathy.
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Dr. Corbier frequently seems to disregard these medical realities in his efforts to establish
that C.A.P. suffered from a Table encephalopathy. For instance, Dr. Corbier’s conclusory
assertion that C.A.P. had “clear regressive symptoms and became encephalopathic” ignores the
pediatrician’s descriptions of C.A.P.’s mental state. See Ex. 98 at 4. In subsequent reports, Dr.
Corbier again concludes that C.A.P.’s “irritability, high fever and lethargic state” were evidence
of acute encephalopathy, but the contemporaneous medical records do not contain the words
“irritable” or “lethargic.” See Ex. 99 at 3. Dr. Corbier asserts that a fever persisting for two
days, coupled with the observation that C.A.P. was “not himself,” indicates altered mental status
and lethargy. Ex. 105 at 2. However, neither altered mental status37 nor lethargy are used to
describe C.A.P. in his medical records.38 Lastly, Dr. Corbier states that on July 24, 2002, the
pediatrician documented that C.A.P. was “weak.” Id. A physical examination was documented,
but the record of it is partly illegible. Regardless, I do not see the word “weak.” Dr. Corbier’s
conclusions of altered mental status and lethargy are erroneous.
In contrast to Dr. Corbier, Dr. Raymond firmly grounds his opinion in the symptoms
documented by C.A.P.’s medical records. He notes, for example, that after C.A.P.’s vaccinations
on July 22, 2002, he had “a few days of fever, but . . . ‘felt better with Motrin and was eating.’”
Ex. L at 2. Dr. Raymond observes that on July 24, C.A.P. had a normal examination, and on
July 25, he was noted to be happy and playful. Id. (citing Ex. 10 at 4). Furthermore, Dr.
Raymond opines that the records from September 2002 show no evidence of altered mental
status. Id. He thus concludes, as I have, that there “is no indication that [C.A.P.] had altered
mental status, was acutely encephalopathic, or was manifesting any degree of neurologic
regression.” Id. at 3.
Based on my review of the medical records and expert reports, I find Dr. Raymond’s
opinions much more accurate and persuasive than those of Dr. Corbier. I find that C.A.P. did not
sustain acute encephalopathy or encephalitis after the vaccination administered to him on July
22, 2002. I also find that C.A.P. did not have onset of acute encephalopathy or encephalitis
within 72 hours of vaccination. I reject petitioners’ assertions that C.A.P.’s symptoms following
vaccination; the family’s efforts to address C.A.P.’s symptoms; the response by C.A.P.’s
pediatrician; or petitioners’ expert reports provide preponderant evidence of a Table injury.
Therefore, I find that petitioners have failed to show by preponderant evidence that C.A.P.
suffered a Table injury.
D. Causation in Fact
Because petitioners have not proven that C.A.P. suffered a “Table injury,” they must
show that he sustained an injury that was actually caused by the vaccines he received. To do so,
37 Examples of altered mental status include confusion, delirium, or psychosis. See 42 C.F.R. §
100.3(b)(2)(i)(B)(1).
38 Similarly, Dr. Porter’s recommendation on July 25 to “call for ↑ listlessness, ↑ vomiting, fever
> 48 [hours] or more” should not be read as an implication that C.A.P. was lethargic. See Ex. 10
at 4. As Dr. Raymond explains, the pediatrician had simply “provided guidance on warning
symptoms which would require return.” Ex. U at 2.
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they must establish, by preponderant evidence: (1) a medical theory causally connecting a
vaccine and C.A.P.’s injury (“Althen Prong One”); (2) a logical sequence of cause and effect
showing that a vaccine was the reason for his injury (“Althen Prong Two”); and (3) a proximate
temporal relationship between a vaccine and his injury (“Althen Prong Three”). Althen v. Sec’y
of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005); § 13(a)(1) (requiring proof by
a preponderance of the evidence). For the reasons set forth below, I find that petitioners have
failed to satisfy the Althen test and are therefore not entitled to compensation.
E. Causation Analysis
i. C.A.P. Did Not Have a Post-Vaccination Encephalopathy.
Although the term “encephalopathy” is less strictly defined in the context of a non-Table
claim, it nevertheless is not so broad as to include any possible type of brain injury, no matter the
degree. See Murphy v. Sec’y of Health & Human Servs., No. 05-1063V, 2016 WL 3034047, at
*25-26 (Fed. Cl. Spec. Mstr. Apr. 25, 2016), mot. for rev. denied, 128 Fed. Cl. 248 (2016);
Wright v. Sec’y of Health & Human Servs., No. 12-423V, 2015 WL 6665600, at *6 (Fed. Cl.
Spec. Mstr. Sept. 21, 2015). Thus, even though a petitioner with a non-Table causation-in-fact
claim might be able to evade some of the Table’s requirements for establishing an
encephalopathy (such as the distinction between “acute” and “chronic” as defined by the Table’s
QAI), a non-Table petitioner will still need to point to reliable evidence from the record
establishing that the injured party’s symptoms were sufficiently evident and severe enough to
constitute an encephalopathy. The decisions of other special masters in non-Table cases have
identified the specific kinds of symptoms that would suggest an individual had experienced an
encephalopathy, including strange forms of crying, anorexia, insomnia, fever, or irritability. See
Cook v. Sec’y of Health & Human Servs., No. 00-331V, 2005 WL 2659086, at *14 (Fed. Cl.
Spec. Mstr. Sept. 21, 2005); Noel v. Sec’y of Health & Human Servs., No. 99-538V, 2004 WL
3049764, at *16 (Fed. Cl. Spec. Mstr. Dec. 14, 2004) (non-Table encephalopathy characterized
by “high-pitched and bizarre, gurgly, cat-like crying, fever, difficulty breathing,
unresponsiveness, and staring off”).
Petitioners’ claim depends on a finding that C.A.P. suffered from an encephalopathy after
vaccination – making this a threshold matter for resolution. See Broekelschen v. Sec’y of Health
& Human Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010) (noting that when an injury or diagnosis
is disputed, and “the proposed injuries differ significantly in their pathology,” the special master
may “first find which of [the] diagnoses was best supported by the evidence presented in the
record before applying the Althen test”). The medical records, however, do not support the
conclusion that C.A.P. experienced any kind of encephalopathic reaction after his vaccinations.
ii. Althen Prong One: Lack of a Reliable Medical Theory
Petitioners must set forth a medical theory explaining how C.A.P.’s vaccines could have
caused his alleged encephalopathy. See Andreu v. Sec’y of Health & Human Servs., 569 F.3d
1367, 1375 (Fed. Cir. 2009); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355-
56 (Fed. Cir. 2006). Although petitioners need not identify the exact mechanism involved, their
theory of causation must be informed by a “sound and reliable medical or scientific explanation.”
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Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994); see also Veryzer
v. Sec’y of Health & Human Servs., 98 Fed. Cl. 214, 223 (2011) (noting that special masters are
bound by both § 13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both
“relevant” and “reliable”). If petitioners rely upon medical opinions to support their theory, the
basis for the opinion and the reliability of that basis must be considered in the determination of
how much weight to afford that opinion. See Broekelschen, 618 F.3d at 1347 (“The special
master’s decision often times is based on the credibility of the experts and the relative
persuasiveness of their competing theories.”); Perreira v. Sec’y of Health & Human Servs., 33
F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“[An] expert opinion is no better than the soundness of the
reasons supporting it.”) (citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980)).
Petitioners have failed to provide preponderant evidence of Althen Prong One for four
reasons. First, the expert reports contain erroneous and misleading information. Second, the
experts’ opinions as to causal mechanisms are conclusory and lack evidentiary support. Third,
some of the proffered opinions are merely speculative. Fourth, the evidence reflects that C.A.P.
does not have a mitochondrial disorder or dysfunction, invalidating petitioners’ most recently
proffered theory.
1. Erroneous and Misleading Information
“[S]pecial masters are expected to consider the credibility of expert witnesses in
evaluating petitions for compensation under the Vaccine Act.” Porter v. Sec’y of Health &
Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011). Erroneous or misleading claims may
profoundly undermine an expert’s credibility. As my fellow special masters have indicated in
past cases, I cannot accept “dubious tactics” such as relying on studies with serious
methodological flaws or quoting medical literature in an inaccurate manner. See, e.g., Rogero v.
Sec’y of Health & Human Servs., No. 11-770V, 2017 U.S. Claims LEXIS 1200, at *135-40 (Fed.
Cl. Spec. Mstr. Sept. 1, 2017).
Both Dr. Bellanti and Dr. Corbier proffer erroneous and misleading information, which
undermine the persuasiveness of their opinions. For example, Dr. Bellanti’s second report
misquotes medical literature and asserts that “there is a documented literature supporting a
relation between vaccines and immunologically-mediated injury of the nervous system and
mental retardation.” Ex. 89 at 3. The referenced literature, however, appears to relate solely to
chromosomal abnormalities and mental retardation. There is absolutely no mention of vaccines
in the article. Moreover, C.A.P.’s medical records do not identify or reference his condition as
mental retardation. Dr. Corbier also offers a very misleading causal theory based on
mitochondrial dysfunction or disorder. See Ex. 98 at 2; Ex. 116. This proffered theory is
irrelevant because C.A.P. was never diagnosed with a mitochondrial disorder. Dr. Corbier’s
opinion based on his assertions that C.A.P. had an altered mental status and was lethargic and
weak on July 24, 2002, is similarly misleading. See Ex. 105 at 2. As discussed above, there is
no evidence to support those assertions.
By including clearly erroneous and misleading information, the experts undermine the
veracity of their opinions as a whole.
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2. Conclusory Expert Opinions
When evaluating whether petitioners have carried their burden of proof, special masters
consistently reject “conclusory expert statements that are not themselves backed up with reliable
scientific support.” Kreizenbeck v. Sec’y of Health & Human Servs., No. 08-209V, 2018 WL
3679843, at *32 n.44 (Fed. Cl. Spec. Mstr. June 22, 2018). The undersigned will not rely on
“opinion evidence that is connected to existing data only by the ipse dixit of the expert.”
Moberly v. Sec’y of Health & Human Servs., 85 Fed. Cl. 571, 596 (2009) (quoting Gen. Elec. Co.
v. Joiner, 522 U.S. 136, 146 (1997)), aff’d, 592 F.3d 1315 (Fed. Cir. 2010). Instead, special
masters are expected to carefully scrutinize the reliability of each expert report submitted. See
id.
Dr. Bellanti’s reports offer textbook illustrations of conclusory opinions. In his first
report, for instance, he makes the following assertion: “It is my opinion that the injury to
[C.A.P.’s] brain was caused by his repeated allergic (immune mediated) reactions to his
vaccines.” Ex. 87 at 3. Dr. Bellanti does not explain how an allergic reaction can cause ASD,
encephalopathy, or any kind of brain injury. In his second report, Dr. Bellanti offers a one-
sentence conclusion as a theory:
A medical theory of causation. As described previously there is a documented
literature supporting a relation between vaccines and immunologically-mediated
injury of the nervous system and mental retardation.
Ex. 89 at 3. Again, Dr. Bellanti fails to explain how vaccines cause an immune-mediated injury
such as mental retardation. In a similar manner, Dr. Corbier offers theories which are simply
assertions without any explanation. See, e.g., Ex. 98 at 3 (stating, without support from the
medical records, that C.A.P. had “clear regressive symptoms and became encephalopathic”).
3. Speculative Theories
Possible theories or mechanisms are insufficient to establish causation by a
preponderance of evidence. “Expert medical testimony which merely expresses the possibility –
not the probability – of the occurrence of a compensable injury is insufficient, by itself, to
substantiate the claim that such an injury occurred.” LaCour v. Sec’y of Health & Human Servs.,
No. 90-316V, 1991 WL 66579, at *5 (Fed. Cl. Spec. Mstr. Apr. 15, 1991); accord Burns v. Sec’y
of Health & Human Servs., No. 90-953V, 1992 WL 365410, at *6 (Fed. Cl. Spec. Mstr. Nov. 6,
1992), aff’d, 3 F.3d 415 (Fed. Cir. 1993). The Federal Circuit has likewise made clear that the
mere possibility of a link between a vaccination and a petitioner’s injury is not sufficient to
satisfy the preponderance standard. Moberly, 592 F.3d at 1322 (emphasizing that “proof of a
‘plausible’ or ‘possible’ causal link between the vaccine and the injury” does not equate to proof
of causation by a preponderance of the evidence); Waterman v. Sec’y of Health & Human Servs.,
123 Fed. Cl. 564, 573-74 (2015) (denying petitioner’s motion for review and noting that a
possible causal link was not sufficient to meet the preponderance standard). While certainty is
by no means required, a possible mechanism does not rise to the level of preponderance. Id.; see
also De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008).
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Dr. Corbier presents his theory that vaccines are environmental triggers as merely a
possible mechanism. Although he opines that “environmental triggers [such as vaccines] play an
important role in the development of neurological disorders,” he does not explain how these
triggers cause injuries such as encephalopathy, learning disabilities, or autism. See Ex. 98 at 1.
At most, he asserts that “the strong association of immunization and neurological regression has
been undeniable for many clinicians and families.” Id. As such, this opinion is legally
insufficient.
4. Mitochondrial Disorder Theory
Petitioners’ newest theory of causation is based on an alleged underlying illness – a
mitochondrial disorder that allegedly resulted in regressive encephalopathy after C.A.P.’s
vaccination. However, mitochondrial DNA testing has been conducted, and the results reflect no
mitochondrial disorder or dysfunction. See Ex. 119. Based on my review of all of the medical
records, the testing results, and the expert reports, I find that the evidence is insufficient to
establish that C.A.P. had a mitochondrial illness.
In conclusion, I note that I am certainly not the first special master to reject medical
theories like those proffered by petitioners’ experts. Many decisions following from the OAP
have addressed causation issues related to autism, encephalopathy, and mitochondrial disease or
dysfunction. In each of these post-OAP cases, petitioners have failed to demonstrate that any
vaccination caused or contributed to the vaccinee’s injury. Additionally, those decisions that
have been challenged have been upheld upon review at the Court of Federal Claims and on
appeal to the U.S. Court of Appeals for the Federal Circuit.39
39 See, e.g., R.K. v. Sec’y of Health & Human Servs., No. 03-632V, 2015 WL 10936124 (Fed. Cl.
Spec. Mstr. Sept. 28, 2015), mot. for rev. denied, 125 Fed. Cl. 57 (2016), aff’d, 671 F. App’x 792
(Fed. Cir. 2016) (mem.); R.V. v. Sec’y of Health & Human Servs., No. 08-504V, 2016 WL
3882519 (Fed. Cl. Spec. Mstr. Feb. 19, 2016), mot. for rev. denied, 127 Fed. Cl. 136 (2016);
Anderson v. Sec’y of Health & Human Servs., No. 02-1314V, 2016 WL 8256278 (Fed. Cl. Spec.
Mstr. Nov. 1, 2016), mot. for rev. denied, 131 Fed Cl. 735 (2017), aff’d, 717 F. App’x 1009 (Fed.
Cir. 2018) (mem.); Holt v. Sec’y of Health & Human Servs., No. 05-136V, 2015 WL 4381588
(Fed. Cl. Spec. Mstr. June 24, 2015); Coombs v. Sec’y of Health & Human Servs., No. 08-818V,
2014 WL 1677584 (Fed. Cl. Spec. Mstr. Apr. 8, 2014); Brook v. Sec’y of Health & Human
Servs., No. 04-405V, 2015 WL 3799646 (Fed Cl. Spec. Mstr. May 14, 2015); Bushnell v. Sec’y
of Health & Human Servs., No. 02-1648V, 2015 WL 4099824 (Fed. Cl. Spec. Mstr. June 12,
2015); Miller v. Sec’y of Health & Human Servs., No. 02-235V, 2015 WL 5456093 (Fed. Cl.
Spec. Mstr. Aug. 18, 2015); Hardy v. Sec’y of Health & Human Servs., No. 08-108V, 2015 WL
7732603 (Fed. Cl. Spec. Mstr. Nov. 3, 2015); Hooker v. Sec’y of Health & Human Servs., No.
02-472V, 2016 WL 3456435 (Fed. Cl. Spec. Mstr. May 19, 2016); Dempsey v. Sec’y of Health &
Human Servs., No. 04-394V, 2017 WL 1058480 (Fed. Cl. Spec. Mstr. Feb. 23, 2017); Pope v.
Sec’y of Health & Human Servs., No. 14-78V, 2017 WL 2460503 (Fed. Cl. Spec. Mstr. May 1,
2017); Kreizenbeck, 2018 WL 3679843.
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For these reasons, the undersigned finds that petitioners have failed to provide
preponderant evidence that the vaccines C.A.P. received could have caused encephalopathy
through the mechanisms set forth by petitioners’ experts.
iii. Althen Prong Two: Lack of a Logical Sequence of Cause and Effect
Althen Prong Two requires petitioners to show, by preponderant evidence, a logical
sequence of cause and effect demonstrating how the vaccines at issue caused C.A.P. to develop
encephalopathy. This logical sequence should be supported by “‘reputable medical or scientific
explanation,’ i.e., ‘evidence in the form of scientific studies or expert medical testimony.’”
Althen, 418 F.3d at 1278 (quoting Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144,
1148 (Fed. Cir. 1992)). As explained above, the medical records in this matter are devoid of any
evidence that C.A.P. ever developed encephalopathy. Moreover, petitioners’ experts do not set
forth any facts or other evidence to support a logical sequence of cause and effect between these
alleged injuries and C.A.P.’s vaccinations.
As thoroughly discussed by Special Master Hastings, petitioners’ experts rely upon
medical presumptions which are not supported C.A.P.’s medical records. For example, Dr.
Bellanti opines that “repeated, allergic (immune mediated) reactions” to vaccines administered in
2002 caused C.A.P.’s encephalopathy, which was diagnosed in 2004. Ex. 87 at 3. The medical
records from 2002 or 2003 do not indicate that C.A.P. suffered from encephalopathy, and
C.A.P.’s treating physicians did not consider the diagnosis during those years. The assertion that
C.A.P. suffered from an encephalopathy that went undetected and untreated for over one year is
not supported by the record.
Furthermore, Dr. Bellanti failed to cite any laboratory results, diagnostic reports, or any
facts from the contemporaneous medical records to suggest that C.A.P. had an allergic reaction
or immune-mediated reaction to the vaccines he received in 2002. In fact, Dr. Bellanti does not
describe or define allergic or “immune-mediation” reactions, nor does he describe the clinical
course of these reactions. As defined by Dorland’s, “allergic reaction” is a phrase used to
describe a hypersensitivity reaction, specifically, type I hypersensitivity. Dorland’s at 1598.
Hypersensitivity is defined as “a state of altered reactivity in which the body reacts with an
exaggerated or inappropriate immune response to what is perceived to be a foreign substance.”
Id. at 896. There are four classifications of hypersensitivity, and type I “occurs rapidly (within
several minutes) upon re-exposure to an antigen.” Id. C.A.P.’s contemporaneous medical
records from 2002 do not show that he was diagnosed with such an allergic reaction,
hypersensitivity, or immune reactions to his vaccines. Dr. Corbier and Dr. Bellanti offer no facts
from C.A.P.’s contemporaneous records to suggest otherwise. Similarly, Dr. Corbier fails to set
forth facts from C.A.P.’s medical records to support his theory of vaccine injury based on
vaccine preservatives and adjuvants.
For all of these reasons, petitioners have failed to provide preponderant evidence of a
logical sequence of cause and effect, as required by Althen Prong Two.
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iv. Althen Prong Three: Lack of a Medically Appropriate Temporal
Relationship
Under Althen Prong Three, petitioners must provide “preponderant proof that the onset of
symptoms occurred within a timeframe which, given the medical understanding of the disorder’s
etiology, it is medically acceptable to infer causation-in-fact.” De Bazan, 539 F.3d at 1352. The
acceptable temporal association will vary according to the particular medical theory advanced in
the case. See Pafford, 451 F.3d at 1358. However, “a temporal relationship alone will not
demonstrate the requisite causal link.” Veryzer v. Sec’y of Health & Human Servs., 100 Fed. Cl.
344, 356 (2011). As explained above, petitioners’ experts did not offer sufficient evidence to
show that the vaccines at issue can cause encephalopathy, much less that C.A.P. did develop
encephalopathy from the vaccines. It follows, then, that petitioner cannot prove Prong Three of
Althen.
In his expert report, Dr. Bellanti asserts that “[t]he onset of serious developmental
abnormalities in timing with the receipt of the vaccines supports a temporal relationship.” Ex. 89
at 3. But the medical records do not demonstrate any developmental abnormality until C.A.P.
was seen by Dr. Kotsanis on October 23, 2003. See Ex. 67 at 3. In the note from that visit, Dr.
Kotsanis documented that C.A.P. fell and sustained a head injury on September 20, 2003. Id.
Dr. Kotsanis noted that C.A.P. was irritable, and that he appeared to “drift slightly to the right
side.” Id. Dr. Kotsanis diagnosed C.A.P. with “post-concussion syndrome” and referred C.A.P.
for hearing and speech evaluations. Id.
C.A.P. received his third set of vaccines on July 22, 2002 (DTaP, Hib, Hep B, and
Prevnar). Ex. 34 at 36. His last vaccination in 2002 was Hep B, administered September 24,
2002. Ex. 10 at 3. No contemporaneous medical records suggest that C.A.P. had any
developmental problems after any of his vaccinations in 2002 or 2003, until the note from Dr.
Kotsanis in October 2003. Petitioners’ experts failed to explain why an onset of greater than one
year after vaccination would be appropriate under any of the proposed mechanisms.
Apart from the assertions of petitioners’ experts, based on misassumptions of facts
related to the onset of the alleged encephalopathy, no facts in the contemporaneous medical
records demonstrate a temporal association between C.A.P.’s vaccinations and the alleged
injuries. Therefore, petitioners have failed to prove Althen Prong Three.
VIII. Conclusion
Over the nearly fifteen years since they filed their petition, petitioners have demonstrated
remarkable patience and dedication. While I commend their commitment to their son’s well-
being, the evidentiary requirements of the Vaccine Act do not allow me to award them
compensation. Thus, because petitioners have not established entitlement to compensation, their
petition must be dismissed for insufficient proof. The Clerk shall enter judgment accordingly.
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IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
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