Hardy v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 08-108V
(To be published)

*************************
*
HAROLD HARDY, III, and *
TIFFANY ANN HARDY-BELL, * Filed: November 3, 2015
legal representatives of HH, a minor, *
*
Petitioners, *
* Autism; Vaccine Act Entitlement;
v. * Causation-in-fact; Significant
* Aggravation; DTaP; Prevnar;
SECRETARY OF HEALTH AND * Table Injury Encephalopathy
HUMAN SERVICES *
*
Respondent. *
*
*************************

Michael L. Cave, Baton Rouge, Louisiana, for Petitioners.
Darryl R. Wishard, U.S. Department of Justice, Washington, D.C., for Respondent.

DECISION1

HASTINGS, Special Master.

This is an action in which the Petitioners, Harold Hardy and Tiffany Ann Hardy-Bell,
seek an award under the National Vaccine Injury Compensation Program (hereinafter the
“Program”2), on behalf of their daughter (“HH”). Petitioners allege that certain vaccinations
administered to HH on August 26, 2005, contributed to the causation of her severe
neurodevelopmental disorder, either by initially causing, or by significantly aggravating, that
disorder. HH has been diagnosed as having a neurodevelopmental disorder that falls within the

1
Because I have designated this document to be published, this document will be made available to the public
unless the petitioners file, within fourteen days, an objection to the disclosure of any material in the decision that
would constitute, “medical files and similar files the disclosure of which would constitute a clearly unwarranted
invasion of privacy.” See 42 U.S.C. § 300aa—12(d)(4)(B); Vaccine Rule 18(b).
2
The applicable statutory provisions defining the Program are found at 42 U.S.C. § 300aa—10 et seq. (2012).
Hereinafter, for ease of citation, all “§” references will be to 42 U.S.C. (2012). I will also sometimes refer to the Act
of Congress that created the Program as the “Vaccine Act.”

1
category of an Autism Spectrum Disorder. For the reasons set forth below, I conclude that the
Petitioners are not entitled to an award on behalf of HH.

I
THE APPLICABLE STATUTORY SCHEME
Under the National Vaccine Injury Compensation Program, compensation awards are
made to individuals who have suffered injuries after receiving vaccines. In general, to gain an
award, a petitioner must make a number of factual demonstrations, including showing that an
individual received a vaccination covered by the statute; received it in the United States; suffered
a serious, long-standing injury; and has received no previous award or settlement on account of
the injury. Finally – and the key question in most cases under the Program – the petitioner must
also establish a causal link between the vaccination and the injury. In some cases, the petitioner
may simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may
be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine
Injury Table,” corresponding to the vaccination in question, within an applicable time period
following the vaccination also specified in the Table. If so, the Table Injury is presumed to have
been caused by the vaccination, and the petitioner is automatically entitled to compensation,
unless it is affirmatively shown that the injury was caused by some factor other than the
vaccination. § 300aa-13(a)(1)(A); § 300aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
In other cases, however, the vaccine recipient may have suffered an injury not of the type
covered in the Vaccine Injury Table. In such instances, an alternative means exists to
demonstrate entitlement to a Program award. That is, the petitioner may gain an award by
showing that the recipient’s injury was “caused-in-fact” by the vaccination in question. § 300aa-
13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). (“Causation-in-fact” is also known as “actual causation.”)
In such a situation, the presumptions available under the Vaccine Injury Table are inoperative.
The burden is on the petitioner to introduce evidence demonstrating that the vaccination initially
caused, or significantly aggravated, the injury in question. Althen v. HHS, 418 F.3d 1274, 1278
(Fed. Cir. 2005); Hines v. HHS, 940 F.2d 1518, 1525 (Fed. Cir. 1991). The showing of
“causation-in-fact” must satisfy the “preponderance of the evidence” standard, the same standard
ordinarily used in tort litigation. § 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines,
940 F.2d at 1525. Under that standard, the petitioner must show that it is “more probable than
not” that the vaccination initially caused or aggravated the injury. Althen, 418 F.3d at 1279. The
petitioner need not show that the vaccination was the sole cause or even the predominant cause
of the injury or aggravation, but must demonstrate that the vaccination was at least a “substantial
factor” in causing or aggravating the condition, and was a “but for” cause. Shyface v. HHS, 165
F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical sequence
of cause and effect showing that the vaccination was the reason for the injury;” and the logical
sequence must 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; Grant v. HHS,
956 F.2d 1144, 1148 (Fed. Cir. 1992).

2
 The Althen court also provided additional discussion of the “causation-in-fact” standard,
as follows:
Concisely stated, Althen’s burden is to show by preponderant evidence that the
vaccination brought about her injury by providing: (1) a medical theory causally
connecting the vaccination and the injury; (2) a logical sequence of cause and
effect showing that the vaccination was the reason for the injury; and (3) a
showing of proximate temporal relationship between vaccination and injury. If
Althen satisfies this burden, she is “entitled to recover unless the [government]
shows, also by a preponderance of the evidence, that the injury was in fact caused
by factors unrelated to the vaccine.”
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not
necessarily supply evidence from medical literature supporting petitioner’s causation contention,
so long as the petitioner supplies the medical opinion of an expert. (Id. at 1279-80.) The court
also indicated that, in finding causation, a Program fact-finder may rely upon “circumstantial
evidence,” which the court found to be consistent with the “system created by Congress, in
which close calls regarding causation are resolved in favor of injured claimants.” (Id. at 1280.)
Since Althen, the Federal Circuit has addressed the causation-in-fact standard in several
additional rulings, which have affirmed the applicability of the Althen test, and afforded further
instruction for resolving causation-in-fact issues. In Capizzano v. HHS, 440 F.3d 1317, 1326
(Fed. Cir. 2006), the court cautioned Program fact-finders against narrowly construing the
second element of the Althen test, confirming that circumstantial evidence and medical opinion,
sometimes in the form of notations of treating physicians in the vaccinee’s medical records, may
in a particular case be sufficient to satisfy that second element of the Althen test. Both Pafford v.
HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006), and Walther v. HHS, 485 F.3d 1146, 1150 (Fed. Cir.
2007), discussed the issue of which party bears the burden of ruling out potential non-vaccine
causes. DeBazan v. HHS, 539 F.3d 1347 (Fed. Cir. 2008), concerned an issue of what evidence
the special master may consider in deciding the initial question of whether the petitioner has met
her causation burden. The issue of the temporal relationship between vaccination and the onset
of an alleged injury was further discussed in Locane v. HHS, 685 F.3d 1375 (Fed. Cir. 2012), and
W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013). Moberly v. HHS, 592 F.3d 1315 (Fed. Cir. 2010),
concluded that the “preponderance of the evidence” standard that applies to Vaccine Act cases is
the same as the standard used in traditional tort cases, so that conclusive proof involving medical
literature or epidemiology is not needed, but demonstration of causation must be more than
“plausible” or “possible.” Both Andreu v. HHS, 569 F.3d 1367 (Fed. Cir. 2009), and Porter v.
HHS, 663 F.3d 1242 (Fed. Cir. 2011), considered when a determination concerning an expert’s
credibility may reasonably affect the outcome of a causation inquiry. Broekelschen v. HHS, 618
F.3d 1339 (Fed. Cir. 2010), found that it was appropriate for a special master to determine the
reliability of a diagnosis before analyzing the likelihood of vaccine causation. Lombardi v. HHS,
656 F.3d 1343 (Fed. Cir. 2011), and Hibbard v. HHS, 698 F.3d 1355 (Fed. Cir. 2012), both again
explored the importance of assessing the accuracy of the diagnosis that supports a claimant’s
theory of causation. Doe 11 v. HHS, 601 F.3d 1349 (Fed. Cir. 2010) and Deribeaux v. HHS, 717
F.3d 1363 (Fed. Cir. 2013), both discuss the burden of proof necessary to establish that a “factor
unrelated” to a vaccine may have caused the alleged injury.

3
 Another important aspect of the causation-in-fact case law under the Program concerns
the factors that a special master should consider in evaluating the reliability of expert testimony
and other scientific evidence relating to causation issues. In Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court listed certain factors that federal
trial courts should utilize in evaluating proposed expert testimony concerning scientific issues.
In Terran v. HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999), the Federal Circuit ruled that it is
appropriate for special masters to utilize Daubert’s factors as a framework for evaluating the
reliability of causation-in-fact theories presented in Program cases.
The Petitioners in this case appear to allege at times that the vaccinations that HH
received on August 26, 2005, initially caused her neurodevelopmental disorder. (Petition, ¶ 23:
Amended Petition, ¶ 23.) Alternatively, at times the Petitioners have alleged that those
vaccinations significantly aggravated a pre-existing condition, causing it to worsen. (E.g.,
Amended Petition, ¶ 21.) According to W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013), “the
National Vaccine Injury Compensation Program *** allows certain petitioners to be
compensated upon showing, among other things, that a person ‘sustained, or had significantly
aggravated’ a vaccine-related ‘illness, disability, injury, or condition.’” Id. at 1355-56, quoting
42 U.S.C. § 300aa-11(c)(1)(C)) (emphasis added.) In Whitecotton v. HHS, 81 F.3d 1099, 1103
(Fed. Cir. 1996), the U.S. Court of Appeals for the Federal Circuit stated that “the statutory
requirements to make out a prima facie significant aggravation claim are analogous to those
required to make out a prima facie initial onset claim.” The Vaccine Act states that “[t]he term
‘significant aggravation’ means any change for the worse in a preexisting condition which results
in markedly greater disability, pain or illness accompanied by substantial deterioration of
health.” § 300aa-33(4).
The elements of an off-Table significant aggravation case are set forth in Loving v. HHS,
86 Fed. Cl. 135, 144 (2009). There, the court combined the test from Althen, above, which
defines off-Table causation cases, with the test from Whitecotton v. HHS, 81 F.3d 1099, 1107
(Fed. Cir. 1996), which concerns on-Table significant aggravation cases. The resultant test has
six components, which are:

(1) the person's condition prior to administration of the vaccine, (2) the person's
current condition (or the condition following the vaccination if that is also
pertinent), (3) whether the person's current condition constitutes a 'significant
aggravation' of the person's condition prior to vaccination, (4) a medical theory
causally connecting such a significantly worsened condition to the vaccination,
(5) a logical sequence of cause and effect showing that the vaccination was the
reason for the significant aggravation, and (6) a showing of a proximate temporal
relationship between the vaccination and the significant aggravation.

Loving, 86 Fed. Cl. at 144; see also W.C. v. HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013) (holding
that “the Loving case provides the correct framework for evaluating off-table significant
aggravation claims”).

4
 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”)3 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);
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).4 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);

3
“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.
4
The petitioners in Snyder did not appeal the decision of the U.S. Court of Federal Claims.

5
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
presiding over their case decide their case on the written record, uniformly 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., Blake v. HHS, No. 03-31V, 2014
WL 2769979 (Fed. Cl. Spec. Mstr. Vowell May 21, 2014) (autism not caused by MMR
vaccination); Henderson v. HHS, No. 09-616V, 2012 WL 5194060 (Fed. Cl. Spec. Mstr. Vowell
Sept. 28, 2012) (autism not caused by pneumococcal vaccination); 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); Holt
v. HHS, No. 05-136V, 2015 WL 4381588 (Fed. Cl. Spec. Mstr. Vowell June 24, 2015) (autism
not caused by Hepatitis B vaccine); 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 (Spec. Mstr. Vowell
Sept. 26, 2015) (autism not caused by MMR vaccination); R.K. v. HHS, (not yet published)
(Spec. Mstr. Vowell Sept. 28, 2015) (autism not caused by influenza vaccine).
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.
6
Mstr. Campbell-Smith Sept. 19, 2012) (autism not caused by MMR vaccination); Bushnell v.
HHS, No. 02-1648, 2015 WL 4099824 (Fed. Cl. Spec. Mstr. Hastings June 12, 2015) (autism not
caused by multiple vaccines); Miller v. HHS, No. 06-753V (Fed. Cl. Spec. Mstr. Hastings Sept.
25, 2012) (autism not caused by DTaP or MMR vaccines); Fesanco v. HHS, No. 02-1770, 2010
WL 4955721 (Fed. Cl. Spec. Mstr. Hastings Nov. 9, 2010); Fresco v. HHS, No. 06-469V, 2013
WL 364723 (Fed. Cl. Spec. Mstr. Vowell Jan. 7, 2013); Pietrucha v. HHS, No. 00-269V, 2014
WL 4338058 (Fed. Cl. Spec. Mstr. Hastings Aug. 22, 2014). Judges of this court have affirmed
the practice of dismissal without trial in such a case. E.g., Fesanco v. HHS, 99 Fed. Cl. 28
(Judge Braden affirming).
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.5

III
FACTS
HH was born on February 23, 2005. (Ex. 1, p. 8.)6 In her initial medical examination,
HH was assessed with a possible heart murmur. (Id., p. 9.) On February 24, 2005, HH received a
Hepatitis B vaccination and was discharged from the hospital. (Id., pp. 8-9.)
Rachel Chatters, M.D., performed an evaluation on March 11, 2005, when HH was two
weeks of age. (Ex. 2, p. 47.) At that time, Dr. Chatters noted that there had been “no problem
since last visit,” and that HH’s developmental assessment was within normal limits. During the
next assessment, on March 31, 2005, Dr. Chatters referred HH to a specialist for further

5
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 (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.” (Decision at 2-3).
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.”)
6
At various times, Petitioners filed medical records and other evidence identified as Petitioners’ Exhibits 1 through
29. I will refer to these items as Ex. 1, 2, 3, etc.

7
evaluation of a heart murmur. (Ex. 2, p. 48.) At a follow-up visit on April 13, 2005, HH’s
mother reported that HH was experiencing choking episodes and a feeding problem. (Ex. 2, p.
49.) Dr. Chatters diagnosed HH with gastroesophageal reflux disease (GERD), and prescribed
treatment with Zantac. (Id.)
On April 28, 2005, when HH was two months of age, Dr. Chatters reported that she was
“doing well,” and her developmental assessment was within normal limits. (Ex. 2, p. 50.) At this
visit, HH received several vaccinations. (Ex. 2, pp. 21, 50.)
On June 6, 2005, HH’s parents took her to the Children’s Clinic of Southwest Louisiana,
because they were concerned that HH was congested, had little appetite, and had trouble
sleeping. (Ex. 2, p. 5.) Dr. Bryan Karriker diagnosed HH with a viral infection. (Id.) One month
later, on June 23, 2005, HH had a “well visit” at the same clinic, where it was noted that she was
developing normally, exhibiting “coos, kicks, smiles.” (Ex. 2, p. 33.) On June 29, 2005, HH
received several more vaccinations. (Ex. 2, pp. 21, 41.)
No irregularities were noted at HH’s check-up at six months of age, on August 26, 2005.
(Ex. 2, p. 6.) HH received DTaP (diphtheria, tetanus, acellular pertussis), Hepatitis B, IPV
(inactivated polio vaccine), and Prevnar (pneumococcal) vaccinations. (Ex. 2, p. 21.)
On September 7, 2005, HH’s mother brought her to the Children’s Clinic again, and
reported that HH had been suffering from congestion, runny nose, and fever, off and on for the
previous 1½ weeks. (Ex. 2, p. 9.) It was also noted that HH had exhibited increased sleeping
and decreased appetite. (Id.) The pediatrician diagnosed right otitis media (ear infection) and an
upper respiratory infection. (Id.) At a follow-up visit one month later, on October 7, 2005, HH
was diagnosed with acute sinusitis and prescribed an antibiotic treatment. (Ex. 2, p. 11.)
HH and her mother returned to the pediatrician’s office on December 21, 2005, with a
renewed complaint of “earache.” (Ex. 2, p. 13.) HH was diagnosed with an upper respiratory
infection and “otalgia.” (Id.) However, during this visit, the pediatrician also indicated that
HH’s development should be monitored, because she was not “scooting” or “crawling.” (Id.) It
was also noted that HH was able to express a “few words.” (Id.)

On January 10, 2006, the pediatrician performed a general check-up and noted HH’s
ongoing constipation. (Ex. 2, p 14.) He also noted significant “developmental concerns” about
HH, such as “not sitting alone, only reaches for things occasionally, slow response if any to
stimuli.” (Id.) HH reportedly remained lethargic after napping, had a slow facial expression,
and would not get on her hands and knees. (Id.) She also exhibited esotropia of the right eye.
(Id.) The physician recorded his diagnoses as “developmental delay” and “esotropia.” (Id.) He
referred HH to an ophthalmologist, and ordered an MRI of the brain, a CMP (comprehensive
metabolic panel) test, and other testing. (Id.) More notes of the visit indicated that HH’s mother
had already contacted “Early Steps,” an early childhood disability program. (Ex. 2, p. 15.) The
CMP and chromosomal test results for HH were normal. (Ex. 2, pp. 4, 24.) The MRI report
indicated “negative” for any abnormalities. (Ex. 2, pp. 26-27.) On January 23, 2006, Dr.
Karriker requested an EEG examination for HH, due to “developmental delay” and to rule out
“absence” seizures. (Ex. 2, p. 35.)

8
 HH was evaluated by Dr. Duane Superneau, a geneticist, on January 26, 2006. (Ex. 6, p.
1.) Dr. Superneau diagnosed HH with neurodevelopmental delay, but he could not identify any
specific syndrome. (Id., pp. 1-2.) The parents reported to him that “by nine months of age” they
had realized HH was behind in her development. (Ex. 6, p. 1.) Further, HH’s parents were
“worried about her losing skills.” (Id.) At this time, Dr. Superneau noted that HH’s “head
circumference is at the lower limits of normal and outside the range of expected for family
average.” (Ex. 6, p. 2.) Dr. Superneau recorded the following assessment:
“Neurodevelopmental delay; [Rule out] seizure disorder; Relative microcephaly.” (Id.) He also
recommended that HH receive an EEG test and be examined by a neurologist, to determine
“whether the spells she seems to exhibit reflect a seizure disorder.” (Id.) The EEG result was
normal. (Ex. 14, p. 8.)
On January 27, 2006, HH was seen again by Dr. Karriker because she was “not crying,
not eating.” (Ex. 2, p. 16.) Dr. Karriker noted that HH’s “eyes [were] dazing off,” that she was
“always tired,” that she would not sit up by herself, would not crawl, would not grab things and
that she was experiencing a decrease in appetite. (Id.)
On February 23, 2006, when HH was 12 months old, she was examined by Dr. Stephanie
Cave. (Ex. 7, p. 53.) Based on her initial discussion with a parent, Dr. Cave recorded that HH
had “stopped progressing” at six to seven months of age, then “regressed” at ten months of age.
(Ex. 7, p. 60.) Dr. Cave diagnosed HH’s condition as: 1) hypotonia, 2) cow milk intolerance, 3)
constipation, and 4) developmental delay. (Ex. 7, p. 53.) Dr. Cave also made a series of
recommendations concerning medicines, nutrition, liver detoxification, and laboratory testing.
(Id., pp. 54-59.)
Dr. Robert P. Cruse, a pediatric neurologist, evaluated HH on June 22, 2006. (Ex. 14, pp.
7-9.) Dr. Cruse recorded the history of HH’s condition, as provided by her parents, including
their belief that HH suffered seizures (“spells of getting tense”) shortly after her birth. (Id., p. 7.)
The parents felt that HH was “normal” for the first six months of life. (Id.) At about that time,
“she received a hepatitis immunization, and the mother reports that two hours after the shot she
had a seizure which was described as staring and unresponsiveness. From that time on, she was
felt to show regression7 and/or lack of progression in her development.” (Id.)
The neurological examination of HH by Dr. Cruse had an outcome characterized as
“abnormal” in many ways. (Ex. 14, p. 9.) Dr. Cruse considered the possibility that HH had a
combined central and peripheral nervous system disorder based on her symptom presentation.
(Id.) He described HH’s series of head circumference measurements, from birth until one year
of age, which showed a gradually slowing rate of growth, and by one year of age resulted in a
head size below the 2nd percentile. (Id., pp. 8-9.) He summarized the following impressions:
Abnormal neurological exam. Microcephaly with head circumference below the
2nd percentile. Of concern is that her head circumference has decreased over time
and crossed percentile lines; it was initially at the 50th percentile up to about 3
months of life * * *.

7
I note that the alleged “regression” was the parents’ opinion, not the opinion of Dr. Cruse. His later comment
regarding regression involved a “regression in head circumference.” (Ex. 14, p. 9.)

9
(Ex. 14, p. 9, emphasis added.) Thus, Dr. Cruse indicated that soon after age 3 months HH had a
declining head growth which indicated a neurologic disorder.

On July 19, 2006, HH received an electromyography (EMG) and a nerve conduction test,
which revealed no evidence of peripheral neuropathy or a myopathy. (Ex. 14, p. 101.) On July
20, 2006, Petitioners wanted to discuss growth hormones for HH with Dr. Karriker. (Id., p. 40.)
On August 9, 2006, Mr. Hardy reported to Dr. Cave’s staff that HH had been hospitalized
for an esophageal perforation caused by swallowing broken glass. (Ex. 7, p. 65; Ex. 14, p. 23.)
Dr. Karriker noted this recent history of “esophageal perforation” when he re-examined her on
August 14, 2006. (Ex. 14, p. 198.) She had delayed motor development as well as hypotonic
reflexes. (Id.) Dr. Karriker noted two chronic ailments, developmental delays and
microcephaly. (Id.) On September 21, 2006, Dr. Karriker examined HH again, noted her
developmental delays and the commencement of speech and physical therapy. (Ex. 14, p. 3.)
In a letter to Dr. Karriker dated March 19, 2007, Dr. Superneau stated that HH’s
symptoms did not suggest a diagnosis of Rett Syndrome. (Ex. 14, pp. 10-11.) A genomic
microarray analysis was performed and the results were normal, so no specific genetic syndrome
had been identified. (Id., p. 11.) He commented that the “microcephaly [abnormally small head
size] in [HH] has been present from prior to the immunizations which have been implicated by
the mother as potentially complicating [HH’s] clinical course.” (Id.) Dr. Superneau concluded
that HH’s “physical findings suggested the problems existed from birth, consistent with the
majority of problems of this type.” (Id.)
Six months later, on October 27, 2007, Dr. Superneau sent another letter to Dr. Karriker.
(Ex. 14, pp. 12-13.) Dr. Superneau maintained that HH had not demonstrated actual regression,
but he noted that HH’s mother remained concerned that HH had regressed. (Id., p. 12.) He
suggested that HH’s family seek out a second opinion from another clinical geneticist. (Id.)
A multidisciplinary evaluation of HH’s educational needs was completed on February 18,
2008, by the Calcasieu Parish School system. (Ex. 22, pp. 1-22.) As part of that process, a
psychologist administered the Autism Diagnostic Observation Schedule (ADOS) to HH, and
concluded that she fell within the category of “autism” (i.e., Autistic Spectrum Disorder.) (Id.,
pp. 1, 8, 21.)

IV
PROCEDURAL HISTORY
A. The initial Petition
The initial Petition in this case was filed on February 25, 2008. The petition was
accompanied by some of HH’s medical records and medical literature.8 The Petition alleged
that the DTaP and Prevnar shots of August 26, 2005,9 either in whole or in part, “caused in

8
Petitioners filed Exhibits 1, 2, and 5 through 9.
9
The Petition, at paragraph 23, mistakenly stated that those vaccinations occurred on August 26, 2006.

10
fact” HH’s encephalopathic condition, esotropia of the right eye, fever, seizure disorder, otitis
media, and resulting neurodevelopmental delay. (Petition, ¶ 23) The Petition alleged that
alternatively, those vaccinations significantly aggravated a pre-existing condition, causing it to
worsen. (Id., ¶ 21.) The Petition did not contain any allegation that HH suffered from a “Table
Injury.”
On April 3 and October 23, 2008, the special master then presiding over this case,
Special Master Gary Golkiewicz, ordered Petitioners to file certain medical records and
affidavits in support of their claim. These items were not filed, but instead on November 18,
2008, Petitioners filed a notification of their intent to remain in the Program and a proposal to
transfer the case into the Omnibus Autism Proceeding (“OAP”). On December 16, 2008, the
special master issued an order which directed Petitioners to show cause why the case should not
be dismissed for failure to prosecute.
Petitioners filed various documents in March 2009.10 Among those documents,
Petitioners included an educational assessment that clearly indicates HH’s diagnosis of
“autism.” (Ex. 22, pp. 1, 21.) On July 6, 2009, Petitioners filed an affidavit by Stephanie Cave,
M.D., which supported their claim of vaccine-induced injury. (Ex. 10.) Thereafter, the special
master authorized transfer of this case to the OAP. (Order, filed Sept. 10, 2009.) For the next
22 months, there was no docket activity in this case, while litigation in the OAP “test cases”
advanced toward completion. (See Section II, above.)
B. The Amended Petition
After the conclusion of the autism “test cases,” Special Master Golkiewicz issued an
order directing the Petitioners in this case to file an Amended Petition that clearly explained their
theory of vaccine causation and included all of the documents required by ' 300aa-11(c). (Order,
filed June 28, 2011.) On July 29, 2011, Petitioners filed an Amended Petition containing the
same claims they had alleged in their initial Petition, with only one change. Based on the
medical opinion of Dr. Cave, the Amended Petition added a new allegation that HH suffered
from a “mitochondrial disorder.” (Amended Petition, ¶ 22.)11
Attached to the Amended Petition was an undated letter from Dr. Cave addressed “To
Whom It May Concern.” (Amended Petition, pp.7-8, hereinafter “Dr. Cave’s First Letter”).12 In
that letter, Dr. Cave stated that
[HH] experienced seizures two hours after receiving the DTaP, Hepatitis B, IPV,
and Prevnar vaccines on August 26, 2005, at six (6) months of age. Her
neurological problems progressed to tonic, clonic movements at age (8) months of

10
Petitioners filed Exhibits 3, 4, and 11 through 22.
11
It should be noted that the Amended Petition alleges the existence of a mitochondrial disorder, while Petitioners’
expert Dr. Cave has repeatedly described an alleged mitochondrial dysfunction.
12
Dr. Cave’s First Letter is not designated as an expert report, nor is it identified on the court’s electronic docket.
The original paper document is marked “Ex. 10(a).” However, that same number was used again to identify a
document filed on January 16, 2012; that is, “Expert Report of Dr. Cave, Ex. 10-a.” That latter document, filed on
January 16, 2012, will be cited in this Decision as “Ex. 10-a.”

11
 age, to crossed eyes at ten (10) months of age. By eleven (11) months, she was
unresponsive without eye contact, and would not cry.
(Dr. Cave’s First Letter.) Dr. Cave described HH’s various symptoms that appeared during the
two years following August 2005, including “gross motor delay, fine motor delay, poor response
to sensory stimulation, weak proximal and distal musculature, delayed self care and delayed
balance.” (Id.) She opined that HH’s “[l]aboratory abnormalities showed mitochondrial
dysfunction, which would explain the hypotonia and muscle weakness, and deficiencies in
vitamin B12, B6 and glutathione.” (Id.) She contended that children with mitochondrial
dysfunction “are prone to patterns of regression if they have infections or immunizations.” (Id.)
Dr. Cave concluded that HH “more likely than not became encephalopathic as a result of the
August 26, 2005 vaccinations.” (Id.)
On August 12, 2011, this case was reassigned to the docket of Chief Special Master
Patricia Campbell-Smith.
During a status conference held on October 5, 2011, Respondent’s counsel indicated that
a review of the records did not disclose any support for the allegation that HH had a
mitochondrial disorder, or suffered any seizures. (Order, filed Oct. 6, 2011.) Following that
discussion, Petitioners were ordered to supplement the record with any test results or other
medical evidence that supported their allegations concerning mitochondrial disorder and
seizures. (Id.) Further, Petitioners were specifically instructed that “any filed expert report
would be expected to provide detailed, pinpoint record citations that speak directly to the factual
record in this case.” (Id.) Petitioners’ counsel subsequently filed a statement acknowledging that
“petitioners are unaware of any additional test results or other medical evidence of HH’s
mitochondrial disorder or HH’s seizures other than the medical records that have previously been
filed in this case.” (Status Report, filed Nov. 3, 2011.)
On November 30, 2011, Petitioners filed an expert report13 by Stephanie F. Cave, M.D., a
board-certified family physician and one of HH’s treating physicians. Dr. Cave’s expert opinion
is summarized in one sentence: “[HH’s] encephalopathic condition, right eye esotropia, fever,
seizures, otitis media, and developmental delay is more likely than not caused by the
vaccinations she received on August 26, 2005, in particular the Hep B, DTaP and Prevnar
vaccines.” (Ex. 10, filed Nov. 30, 2011.) Upon review of this report, Special Master Campbell-
Smith filed an Order noting that there was “a lack of documentary support for the factual
allegations that were made in the expert report.” (Order, filed Dec. 12, 2011.) Petitioners were
directed to file a supplemental expert report from Dr. Cave that was factually supported by
medical records (including exhibit numbers and specific page numbers). (Id.) In response, on
January 16, 2012, Petitioners filed an amended supplemental report from Dr. Cave, identified as
“Ex. 10-a.” With a few insignificant changes, this report contained the same statements
concerning encephalopathy, mitochondrial dysfunction, and seizures that were presented in Dr.
Cave’s “First Letter.” However, despite the special master’s orders, many of the factual
allegations in Exhibit 10-a still were not accompanied by any specific citations to the filed
medical records.

13
The filing on November 30, 2011, marked as Exhibit 10 on the paper filing, is identified on the electronic docket
as “Expert Report of Dr. Cave.” It will be referred to as “Ex. 10.”

12
C. Court orders requiring more evidence from Petitioners
After reviewing the filed medical records and Dr. Cave’s expert report, Special Master
Campbell-Smith issued a lengthy Order explaining that both the factual record and Dr. Cave’s
expert report fell short of establishing that the vaccines that HH received on August 26, 2005,
caused her alleged encephalopathy and developmental delay. (Order, filed on March 2, 2012, p.
10.) This Order explained that Petitioners’ allegations concerning an “encephalopathy” were
insufficient to establish a “Table Injury,” and further, there was no evidence in the medical
record that HH experienced an encephalopathy following her vaccinations. (Id., pp. 2-3.) Also,
there was “no evidentiary support for petitioners’ claim that [HH] has a mitochondrial disorder
or suffers from seizures.” (Id., p. 5.)
In that order, Special Master Campbell-Smith observed that Petitioners’ expert witness,
Dr. Cave, had not proposed a medical theory of vaccine-related causation, and that the doctor
lacked specialized education and training in genetics, neurology, and/or immunology that would
give probative weight to her opinions. (Order, filed on March 2, 2012, pp. 4-5.) The Order also
discussed evidence in the medical record suggesting a pre-natal origin for HH’s condition. (Id.,
pp. 7-8.) Based on these and other shortcomings in Petitioners’ claim, the Order concluded that
“the reasonableness of moving forward is in question.” (Id., pp. 9-10.)14
In light of these deficiencies in Petitioners’ claim, they were ordered to file a response
indicating how they intended to proceed. (See Order, filed March 2, 2012, p. 10; see also Show
Cause Order, filed April 10, 2012.) In response, Petitioners filed a Status Report on May 10,
2012, suggesting that they would ask their expert to review the matter. Thereafter, another
Order was issued, which again required Petitioners to show cause why the case should not be
dismissed, since they “have not addressed the stated inadequacies with their supplemental expert
report.” (Show Cause Order, filed May 14, 2012.)
On June 27, 2012, Petitioners filed additional medical records and medical articles (Exs.
23-26), and another supplemental expert report (Ex. 10-b), with Dr. Cave’s curriculum vitae
attached. This lengthy “Second Supplemental Report” by Dr. Cave was intended to “address the
issues raised by the court.” (Ex. 10-b, p. 2) In that report, Dr. Cave discussed a theory of vaccine
causation, and her opinions concerning mitochondrial dysfunction and alleged symptoms of
encephalopathy. (Id., pp. 4-8.) Within the context of this discussion, Dr. Cave argued that “the
case could be considered a Vaccine Table Case.” (Id., p. 14.)

D. Moving forward toward a trial
Petitioners filed a Status Report on June 28, 2012, indicating their desire to proceed to an
evidentiary hearing. On July 6, 2012, Special Master Campbell-Smith issued an Order stating
that while Petitioners’ recent filings were responsive to the recent show cause order, the special
master’s concerns about various issues still persisted. Nonetheless, in preparation for a hearing,

14
While it is not relevant to this Decision, I note that Special Master Campbell-Smith issued two Orders clearly
questioning whether an award of attorneys’ fees and costs for further litigation of this matter might be considered
“unreasonable.” (Order, filed March 2, 2012, p. 9; Order, filed April 8, 2013, p. 5.)

13
Respondent was ordered to file a “Rule 4 report” and an expert report. (Order, filed July 6,
2012.) On October 5, 2012, Respondent filed a “Rule 4 report,” along with the expert opinion
of Dr. Max Wiznitzer, M.D. (Exhibit A.)15
On April 3, 2013, counsel for both parties participated in a status conference to discuss
how this case would proceed. Special Master Campbell-Smith filed another lengthy Order
reiterating that the factual allegations made by Dr. Cave concerning the existence of symptoms
of a Table encephalopathy or seizures could not be confirmed by contemporaneous medical
records. (Order, filed April 8, 2013, pp. 1-3.) That Order noted that only the retrospective
accounts of the parents supported Dr. Cave’s recorded history of HH’s condition, and the Special
Master declined to base her factual determinations on those unsubstantiated claims. (Id.) The
Order noted that the parties’ experts “disagreed entirely” with regard to evidence of
mitochondrial dysfunction, and a factual determination could be made only if Petitioners
provided a fuller explanation of their theory linking HH’s injury to mitochondrial dysfunction
and vaccines. (Id., p. 3-4.) The Order also noted that Dr. Cave possessed far less of the
specialized training needed to offer “an opinion on the neurological aspects of this matter,”
compared to a pediatric neurologist, such as respondent’s witness, Dr. Wiznitzer. (Id., p. 5.)
On April 9, 2013, this case was reassigned to my docket.16
Petitioners filed a supplemental report from Dr. Cave, on May 29, 2013, acknowledging
that Petitioners could not support a finding that HH suffered a Table encephalopathy, or that she
had suffered post-vaccination seizures, without relying on the statements of HH’s parents. (Ex.
27, p. 1.) Following these concessions, Dr. Cave’s supplemental report asserted that HH
suffered from a mitochondrial dysfunction, which allegedly made her vulnerable to injury due to
the effects of aluminum, a vaccine adjuvant. (Id., pp. 4-5.)17
Petitioners indicated that they wanted to move forward with an evidentiary hearing.
(Status Report, filed June 26, 2013.) During a status conference on July 2, 2013, Petitioners
reiterated their intention to proceed to a trial consisting of expert testimony, but stated that it
would not be necessary to present their own personal testimony. (Order, filed July 8, 2013.)
Pursuant to instructions from the court, Respondent filed a Pre-Hearing Brief on January
10, 2014, and Petitioners filed a Pre-Hearing Brief on January 14, 2014. An evidentiary hearing
featuring testimony only from the expert witnesses (Dr. Cave and Dr. Wiznitzer) occurred on
February 7, 2014. The transcript of those proceedings became available on March 11, 2014. (See
Transcript of Proceedings (“Tr.”).) Petitioners filed their Post-Hearing Brief on September 8,
2014; and Respondent filed a Post-Hearing Brief on November 21, 2014. Petitioners had the
opportunity to file a reply brief, but did not do so.

15
On October 5, 2012, Respondent filed Exhibits A through E, followed by Exhibit F on February 4, 2014. I will
refer to these items as Exs. A, B, C, etc.
16
This reassignment was due to the imminent appointment of Special Master Campbell-Smith as a Judge of this
court.
17
Dr. Cave stated, “The patterns of [HH’s] developmental delay may have been determined by genetics or
prenatally determined, but it is possible that mitochondrial dysfunction did either exacerbate or increase the severity
of the delay.” (Ex. 27, p. 4, emphasis added.)

14
 V
SUMMARY OF EXPERT WITNESSES’ CREDENTIALS AND OPINIONS

At this point, I will briefly summarize both the qualifications and the opinions of the
expert witnesses.
A. Petitioners’ expert -- Dr. Stephanie F. Cave
Stephanie F. Cave, M.D., graduated from Louisiana State University (“L.S.U.”) in 1966,
with a B.S. degree in medical technology, then served as a medical technologist at the Ochsner
Foundation Hospital. (Ex. 29, pp. 1-2.) From 1972 to 1979, Dr. Cave taught clinical chemistry,
medical mycology, and hematology at the Department of Allied Health of L.S.U. (Id., p. 2.) She
received a M.S. degree in clinical chemistry from L.S.U. in 1978. (Id.)
In 1983, Dr. Cave received her medical degree from the L.S.U. School of Medicine. (Ex.
29, p. 1.) Dr. Cave performed her medical internship and residency in family medicine, between
1983 and 1986, at the Earl K. Long Memorial Hospital, where she served as chief resident in
1986. (Id.) She served as a preceptor at the L.S.U. Department of Family Medicine from 1986
until 2003. (Id.) Dr. Cave was certified by the American Board of Family Practice in 1986, and
re-certified repeatedly, most recently in 2011. (Id.)
In 1986, Dr. Cave commenced a private practice in “Family Medicine/Integrative
Medicine,” which she continues to the present. (Ex. 29, p. 2.) That practice specializes in
children with developmental delays, and Dr. Cave states that over the past decade, she has
participated in treating over 10,000 children with autism. (Id., p. 1; Tr. 8, 40.) She currently
maintains hospital privileges at Our Lady of the Lake Hospital and Women’s Hospital in Baton
Rouge. (Tr. 44.)
As part of her specialized practice, Dr. Cave has delivered a multitude of professional
presentations concerning autism and immunizations, throughout the United States and
internationally. (Ex. 29, pp. 3-6.) She has written or co-authored four articles addressing that
topic, and a book entitled What Your Doctor May Not Tell You About Children’s Vaccinations.18
(Ex. 29, p. 6; Tr. 8.) She has testified before the U.S. House Committee on Governmental
Reform regarding mercury in vaccines, and before a Louisiana state legislative committee
regarding the safety of the MMR vaccine. (Id.)
Dr. Cave is the mother of Petitioners’ counsel, Michael L. Cave. (Tr. 40.)

B. Summary of opinion of Petitioners’ expert
On November 30, 2011, Petitioners filed an expert report by Dr. Cave, which contended
that “Children with mitochondrial dysfunction are prone to patterns of regression if they have
infections or immunizations,” and that “[HH] is such a child with mitochondrial dysfunction
who experienced a seizure two hours after the vaccine series on August 26, 2005.” (Ex. 10, p.
1.) Dr. Cave opined that HH “more likely than not became encephalopathic as a result of the
August 26, 2005 vaccines and remains so today.” (Id.)

18
What Your Doctor May Not Tell You About Children’s Vaccinations (Hachette Books 2010).

15
 Petitioners filed a second report of Dr. Cave on January 16, 2012. That report reasserted
that HH was afflicted with a “mitochondrial dysfunction,” but did not include any references to
“seizures.” (Ex. 10-a.) Rather, it asserted that, according to reports by her parents, HH suffered
a “regression in development” following the vaccinations of August 26, 2005. (Ex. 10-a, p. 2.)
Dr. Cave observed that “vaccines could offer environmental triggers that induce inflammation
and immune dysfunction in the children with mitochondrial dysfunction.” (Id.) Dr. Cave
concluded that HH “more likely than not became encephalopathic and regressed
developmentally” as a result of those vaccines. (Id.)
On June 27, 2012, Petitioners filed another, more extensive version of Dr. Cave’s
opinion, which contended that HH “suffered an acute encephalopathy following the vaccines
given on August 26, 2005,” and that her case “could be considered a Vaccine Table case.” (Ex.
10-b, p. 13.) Dr. Cave contended that, based on parental recollections, HH suffered seizure-like
symptoms soon after her vaccinations of August 26, 2005. (Id., p. 7.) Dr. Cave also argued
that HH had a “mitochondrial dysfunction” that made her likely to suffer regression in response
to immunizations. (Id., pp. 4-6, 14.) She supported her diagnosis of mitochondrial dysfunction
by citing HH’s laboratory test results that allegedly showed aberrant levels of various
metabolites. (Id., pp. 5-6.) Dr. Cave argued that these test results, along with a re-analysis of
HH’s symptoms, fulfilled or exceeded all of the factors emphasized in a seminal study of
mitochondrial disease, published by Morava, et al.19 (Id., pp. 5-6.) Dr. Cave disagreed with
notations by HH’s treating physicians (Drs. Superneau and Cruse) that the history of HH’s rate
of head growth indicated onset of HH’s condition before she received the vaccinations at issue
here. (Id., pp. 7-9.) These treating physicians, she argued, had miscalculated HH’s rate of head
growth during infancy. (Id.)
Thereafter, in response to an order from the court, Dr. Cave prepared a supplemental
report, which was filed on May 29, 2014. (Ex. 27.) That report acknowledged that Petitioners
could not support a finding that HH suffered from a “Table encephalopathy” based on the
medical records, without relying exclusively on the recollections of her parents. (Id., p. 1.)
Likewise, Dr. Cave conceded that Petitioners are unable to demonstrate that HH experienced
seizures following the vaccinations of August 26, 2005, except by relying entirely on parental
statements. (Id.)
Instead, Dr. Cave reviewed various laboratory test results and comments recorded in the
medical records that allegedly support her contention that HH suffered from mitochondrial
dysfunction. (Ex. 27, pp. 1-4.) She also stated that HH possessed two genetic mutations that
allegedly decreased her ability to detoxify neurotoxic adjuvants contained in vaccines (such as
aluminum), which allegedly increased “oxidative stress” on her central nervous system. (Id., p.
5.) Dr. Cave opined that “[t]he patterns of [HH’s] developmental delay may have been
determined by genetics or prenatally determined, but it is possible that the mitochondrial
dysfunction did either exacerbate or increase the severity of the delay.” (Id., p. 4, emphasis
added.)

Finally, Dr. Cave concluded that her “explanation of vaccine contents, the effect of
immunization on a child with mitochondrial dysfunction, the deleterious effects of

19
E. Morava, et al., Mitochondrial Disease Criteria: Diagnostic Applications in Children, 67 Neurology 1823-26
(2006), filed as Respondent’s Ex. C, on October 5, 2012.

16
malfunctioning mitochondria in the development of the brain of a child and the showing of a
proximate temporal relationship between the vaccination and the injury satisfy the Althen
criteria in this case.” (Ex. 27, p. 7.) She concluded by asserting that the “DTaP vaccine” of
August 26, 2005, “caused the injury” to HH. (Id.)

Dr. Cave’s testimony during the evidentiary hearing on February 7, 2014, incorporated
some but not all aspects of her four written reports. During the hearing, Dr. Cave relied chiefly
upon her understanding that HH suffered a severe adverse event during the 24 hours after her
August 2005 vaccinations, and that HH had a mitochondrial dysfunction that made her
susceptible to injury by the vaccines.
C. Respondent’s expert -- Dr. Max Wiznitzer
Max Wiznitzer, M.D., received his B.S. degree in medical education in 1975, and a
medical degree in 1977, both from Northwestern University. (Ex. B, p. 1; Tr. 66-67.) He
completed his residency in pediatrics, in 1980, at the Children’s Hospital Medical Center in
Cincinnati, Ohio. (Id.) He completed a one-year fellowship at the Cincinnati Center for
Developmental Disorders; a three-year fellowship in pediatric neurology at the Children’s
Hospital of Philadelphia; and a two-year fellowship at the Albert Einstein College of Medicine in
New York, studying higher cortical functions. (Ex. B, pp. 1-2.)
Dr. Wiznitzer has received appointments to practice at several hospitals for various
lengths of time, including at the Department of Neurology of Montefiore Medical Center in New
York; at the Department of Neurology at Bronx Municipal Hospital Center; and at Rainbow
Babies and Children’s Hospital in Cleveland. (Ex. B, p. 2.) He has also served as a consultant in
pediatrics and neurology at several other hospitals. Dr. Wiznitzer has also maintained a
continuous practice as an associate pediatrician and associate neurologist at University Hospitals
of Cleveland, since 1986. (Id.) He sees approximately 200 to 300 children per month, the vast
majority of them exhibiting developmental disorders, and more than 25% of them diagnosed
with autism. (Tr. 71.)
At Rainbow Babies and Children’s Hospital, in Cleveland, Dr. Wiznitzer served as
Co-Director of the Rainbow Autism Center in 1991; as Chief of the Division of Pediatric
Neurology from 1992 to 1995; and, concurrently, as the Director of the Rainbow Autism Center,
from 1992 through 2010. (Ex. B, p. 3.)
Dr. Wiznitzer is certified by the American Board of Pediatrics. (Ex. B, p. 5; Tr. 67.) He
also received certification from the American Board of Psychiatry and Neurology, with a special
qualification in Child Neurology. (Ex. B, p. 5.) In 2004, the American Board of Psychiatry and
Neurology certified his competence in Neurodevelopmental Disabilities. (Id.) He maintains a
license to practice medicine in Ohio, Pennsylvania and New York. (Id.)
Concurrent with his hospital practice, Dr. Wiznitzer has instructed medical students,
residents and attending doctors since 1984, when he was an instructor at the Albert Einstein
College of Medicine. (Tr. 67.) Most notably, he has taught pediatrics and neurology since 1986
at the Case Western Reserve University School of Medicine. (Tr. 65-66; Ex. B, pp. 9-11.)
Dr. Wiznitzer has performed medical research funded by grants from the National
Institutes of Health, and various university medical programs. (Ex. B, p. 4.) He has been a

17
reviewer of articles for many medical journals, most notably for Pediatric Neurology, Lancet
Neurology, and the Journal of Child Neurology, where he also served on the editorial boards.
(Id., p. 6.) He currently serves on a multitude of medical advisory groups at the local, state, and
national levels. (Id., pp. 6-9.) Dr. Wiznitzer has published fifty-eight medical articles, eleven
book chapters, and fifty-five abstracts. (Id., pp. 13-23.) He has also presented numerous lectures
at the invitation of community organizations concerning childhood developmental disorders,
primarily on the subject of autism. (Id., pp. 23-55.)
D. Summary of opinion of Respondent’s expert
The opinion of Respondent’s expert was first set forth in Exhibit A, filed on October 5,
2012. Dr. Wiznitzer opined that the first symptoms of HH’s neurodevelopmental disorder
occurred prior to her vaccinations of August 2005. (Ex. A, pp. 12-13.)
Dr. Wiznitzer rejected Petitioners’ allegation that HH suffered a “Table Injury
encephalopathy,” because she did not exhibit symptoms of a “decreased level of consciousness”
lasting for more than 24 hours, during the 72 hours following the vaccinations of August 26,
2005. (Ex. A, p. 10.) Further, he noted that HH’s contemporaneous medical records make no
mention of encephalopathic changes in her level of consciousness after her August
vaccinations, but describe only the typical symptoms of upper respiratory infection and otitis
media. (Id.)
Likewise, Dr. Wiznitzer considered and rejected Petitioners’ claims that HH suffered
seizures shortly after her August 2005 vaccinations, or in the months thereafter. (Ex. A, p. 13.)
He noted that multiple physicians, including pediatric neurologists and a pediatric epileptologist
(Dr. Wilfong) examined HH, but none of them diagnosed a seizure disorder or prescribed
anticonvulsant medications. (Id.)
Dr. Wiznitzer contended that HH has not presented the symptoms of a mitochondrial
disorder or dysfunction, based on the criteria set forth in the Morava article. (Ex. A, pp. 10-12,
referring to the article filed as Ex. C.) He explained that Dr. Cave misinterpreted HH’s medical
history with regard to many of those criteria, and greatly exceeded the scoring allowed pursuant
to the Morava criteria. (Id., p. 12.) While Dr. Cave’s method of assigning points produced a
score of “14,” Dr. Wiznitzer’s recalculation of those points produced a score of “1,” which he
interpreted as “mitochondrial disorder unlikely.” (Id.)
Dr. Wiznitzer’s testimony at the hearing on February 7, 2014, was consistent with, and
further explained, the opinions set forth in his written expert report. Based on his own
examination of HH’s medical record, Dr. Wiznitzer concluded that “the August 26th, 2005,
vaccination did not cause or significantly aggravate her present neurologic condition.” (Tr. 71.)

VI
ISSUES TO BE DECIDED
Unfortunately, it is not completely clear exactly what Petitioners are arguing in this
case. For example, as will be detailed below (see Section VII(B) of this Decision), Petitioners
and Dr. Cave were not even clear as to what vaccinations they allege to have harmed HH.
Further, some of the allegations set forth in Petitioners’ Amended Petition appear to have been
abandoned by the Petitioners. For example, Petitioners at one time alleged that HH’s esotropia

18
of the right eye and her otitis media (ear infection) were “caused-in-fact” by her DTaP and
Prevnar vaccinations. (Amended Petition, p. 1.) Petitioners’ expert, Dr. Cave, initially
supported those allegations (Ex. 10), but did not substantiate those particular claims, or even
mention them, in her several subsequent expert reports or her trial testimony. Further, the
allegations stated by Petitioners in their Post-Hearing Memorandum do not always correspond
to Dr. Cave’s testimony.
This Decision, accordingly, will be organized according to the two general theories of
vaccine causation which seem to have been advocated by Petitioners, at the evidentiary hearing
and in their Post-Hearing Memorandum. Specifically, the two primary issues to be decided
here are: 1) whether HH suffered a “Table Injury encephalopathy;” and 2) whether, as
Petitioners alternatively argue, HH’s vaccinations of August 26, 2005, played any role in
“causing-in-fact” her neurodevelopmental disorder, either by “initially causing,” or by
“significantly aggravating,” that disorder.

VII
RESPONDENT’S EXPERT WAS FAR MORE PERSUASIVE IN GENERAL
THAN PETITIONERS’ EXPERT
For all of the reasons set forth in this section and the sections of this Decision below, I
conclude that Petitioners have failed to demonstrate that it is “more probable than not” either that
HH suffered a “Table Injury encephalopathy,” or that HH’s vaccinations of August 26, 2005,
played any role in initially causing, or aggravating, her neurodevelopmental disorder. And the
first of the reasons for this conclusion is simply that I found Respondent’s expert, Dr. Wiznitzer,
to be far more persuasive than the expert upon whom Petitioners relied, Dr. Cave.

A. Qualifications
Dr. Wiznitzer regularly diagnoses and treats children with mitochondrial disorders as
part of his everyday clinical practice, in conjunction with mitochondrial and metabolism experts.
(Tr. 70.) He received training concerning mitochondrial disorders and neurotoxicology as part of
his training for board certifications in both pediatric neurology and neurodevelopmental
disorders. (Id.)
Dr. Wiznitzer’s clinical practice and academic career are focused on children’s
neurodevelopmental disorders, particularly Autism Spectrum Disorders (ASDs). He devotes
approximately 36 hours each week to evaluating and treating children with neurological illnesses
such as ASD, seizure disorders, and developmental delay. (Tr. 68.) More than 25% of his
regular caseload of 200 to 300 children per month are diagnosed with ASD. (Tr. 71.) Under the
auspices of the National Institutes of Health, he has participated in major research projects
concerning ASDs. (Ex. B, p. 4.) He has served on the editorial boards of medical journals
dedicated to childhood neurological disorders, such as Pediatric Neurology, Lancet Neurology,
and the Journal of Child Neurology, and published numerous articles about ASDs in these and
other prominent medical journals. (Id., p. 6; see also Ex. B, pp. 13-17.) He is the author of
several medical textbook chapters devoted to ASDs and related disorders. At the Rainbow
Babies and Children’s Hospital in Cleveland, Dr. Wiznitzer was Director of the Rainbow Autism

19
Center, from 1992 to 2010. (Ex. B, p. 3.) For all these reasons, he is extremely well qualified to
offer an opinion about the matters under consideration here.
In contrast with Dr. Wiznitzer’s strong credentials, Dr. Cave lacks strong expert
qualifications to opine about the complex issues presented in this case. Beginning with a status
conference on October 5, 2011, Petitioners were advised by Special Master Campbell-Smith that
Dr. Cave lacked the expertise to be appropriately responsive to Respondent’s expert. (Order,
filed Oct. 6, 2011.) Five months later, Petitioners were reminded that less evidentiary weight
would be afforded to the opinion of an expert such as Dr. Cave, who did not have specialized
training as a developmental-behavioral pediatrician, a geneticist, a neurologist, or an
immunologist. (Order, filed Mar. 3, 2012, pp. 3-4.) On April 4, 2013, Special Master Campbell-
Smith considered Dr. Cave’s qualifications as a family practitioner, and commented that - -
[A] competent medical doctor may be successful in treating the medical needs of
children with developmental delays, like [HH], without possessing the expertise
to put forward the type of expert opinion that satisfies the Althen criteria.
Respondent has engaged a pediatric neurologist to opine in this matter, and such
witness will most likely bring a more expansive set of skills, education and
expertise to bear when offering an opinion on the neurological aspects of this
matter.
(Order, filed April 8, 2013, p. 5.) Special Master Campbell-Smith’s comparison of the
qualifications of the competing experts in this case proved to be quite accurate.20
To be sure, Dr. Cave is a physician board-certified in the area of family practice, who, to
her credit in this regard, has spent much of her lengthy medical career engaged in treating
children with autism spectrum disorders. (E.g., Tr. 8, 40.) However, Dr. Wiznitzer has far
superior academic credentials and specialized medical training qualifications in the area of
ASDs and ASD diagnosis.

Thus, in terms of specialized medical training relevant to ASDs, Dr. Wiznitzer has the
much superior resume.

B. Superior ability of Dr. Wiznitzer to explain his opinion
In addition to the vast gap between Dr. Cave and Respondent’s expert in qualifications,
there was an even greater gap in the experts’ ability to explain their opinions. The written
reports and hearing testimony of Wiznitzer seemed to me to be coherent and logical. In contrast,
the written reports of Dr. Cave were not well explained and contained significant factual errors,
while her hearing testimony was often poorly explained, self-contradictory, and less than logical.

20
In Blake v. HHS, No. 03-31V, 2014 WL 2769979 (Fed. Cl. Spec. Mstr. May 21, 2014) the presiding special
master (Vowell) issued a warning order very similar to the Orders filed in this case. On February 15, 2012, the
petitioners in Blake were advised concerning “Dr. Cave’s lack of expertise in the relevant specialties of
developmental pediatrics, pediatric neurology, or pediatric immunology,” Id. at *3. Eventually, eligibility to an
award was denied in Blake, largely due to Dr. Cave’s lack of qualifications to opine as petitioners’ expert. Id. at
*15.

20
 In this regard, I note that, as suggested above, both Dr. Cave and Petitioners’ counsel
never even made it completely clear exactly what they are arguing in this case. For example,
they were inconsistent even in stating which vaccinations they believe to have harmed HH. In
Dr. Cave’s first, second, and third written expert reports, she seems to indicate only that the
“vaccinations” of August 26, 2005, harmed HH, without specifying which of those vaccinations
harmed HH. (Ex. 10, Ex. 10-a, Ex. 10-b.) Then, in her fourth written report she pointed only to
the “DTaP vaccine” as the alleged agent of harm. (Ex. 27, p. 7.) But in her trial testimony, Dr.
Cave merely referred to all of the vaccines received by HH on August 26, 2005, and seemed to
imply, without ever clearly stating, that alleged unspecified toxins in those “vaccines” harmed
HH. (E.g., Tr. 14-15.)
To add to the confusion, in both Petitioners’ initial Petition (p. 1) and their Amended
Petition (p. 1), Petitioners’ counsel pointed only to the DTaP and Prevnar vaccinations as
allegedly causing harm. And their Pre-Hearing Memorandum (filed on January 14, 2014) was
confused, at one time pointing simply to the “August 26, 2005 vaccines” (p. 7, line 8), but later
on the same page pointing only to the DTaP vaccination (p. 7, line 20). Their Post-Hearing
Memorandum again was unclear, not specifying at all what vaccines allegedly caused injury to
HH.
Further, Dr. Cave seemed at times to be very unsure of her “causation” conclusion. For
example, in her expert report, Dr. Cave stated that “[t]he patterns of [HH’s] developmental delay
may have been determined by genetics or prenatally determined, but it is possible that
mitochondrial dysfunction did either exacerbate or increase the severity of the delay.” (Ex. 27, p.
4, emphasis added.) Thus, according to Dr. Cave herself, it is only possible that a mitochondrial
dysfunction contributed to HH’s condition. During the hearing Dr. Cave also testified that--
[i]t’s not really clear whether or not [HH] had a genetic problem or whether it
was something that was caused or exacerbated by an environmental toxin, but the
– in the DTaP vaccination that she received on August 26th, 2005, the aluminum
that was used as an adjuvant is actually to prolong the immune stimulation for the
best result, and this would not be something that would be tolerated by a child
with mitochondrial dysfunction, because it increases oxidative stress.
(Tr. 33-34, emphasis added.) Thus, Dr. Cave admitted that “it’s not really clear” what caused
HH’s condition. These ambiguous statements do not constitute a persuasive expert opinion that
HH, more likely than not, suffered an injury that was caused by one or more vaccinations.
Rather, Dr. Cave’s descriptions of her own theory of causation, in the quotations above,
acknowledged her inability to make a clear attribution of causation, and this acknowledgment
was then followed by her speculation about what might be possible.
Moreover, as will be detailed below (see section IX(D) of this Decision), while Dr. Cave
relied on her (erroneous) belief that HH suffered from a “mitochondrial dysfunction,” Dr. Cave
made no serious attempt to explain why such a circumstance would therefore tend to show that
vaccinations either initially caused or aggravated HH’s neurodevelopmental disorder. Dr. Cave
did not present any explanation of her theory that the presence of “mitochondrial dysfunction”
would make an infant more susceptible to the unspecified “toxins” in unspecified vaccines. She
simply did not explain her theory in this regard in any detail. Dr. Cave merely seemed to assume
that the presence of “mitochondrial dysfunction” would render an infant more susceptible to

21
purported vaccine-related damage. But she presented no persuasive reason why I should adopt
such an assumption.

C. Dr. Cave’s reliance on alleged occurrences not substantiated by the medical records
Another very important difference between Dr. Cave and Dr. Wiznitzer was the huge gap
in the two experts’ ability to base their opinions on HH’s medical records. The written report
and hearing testimony of Dr. Wiznitzer was well grounded in HH’s medical records, while Dr.
Cave’s opinion was contradicted by those medical records.
In this regard, I note that Dr. Cave’s early reports in this case were not based on HH’s
medical records; rather, they were based on the parents’ retrospective accounts of events and
symptoms that were not reported in HH’s medical records. As noted above, a prior presiding
special master in this case, Special Master Campbell-Smith, ordered Petitioners to file
supplementary expert reports with specific citations to the medical records, in order to
substantiate Dr. Cave’s allegations concerning alleged symptoms of seizures, encephalopathy,
and/or “mitochondrial dysfunction,” which HH may have experienced. (See Orders, filed on
Oct. 6, 2011; Dec. 12, 2011; Mar. 2, 2012; Apr. 8, 2013.) Eventually, Dr. Cave acknowledged
that she could not support the allegations that HH suffered a Table encephalopathy, or that she
suffered post-vaccination seizures, without relying entirely on the statements of HH’s parents.
(Ex. 27, p. 1.)
The sequence of events described above is disturbing because Dr. Cave is not new to the
Vaccine Program, and she had previously been advised that causation conclusions that are not
based on medical records would be in grave danger of rejection for that reason. In Berge v.
HHS, No. 08-223V, 2010 WL 3431601 (Fed. Cl. Spec. Mstr. Aug. 2, 2010), the presiding special
master dismissed the case largely because, “[i]n light of Dr. Cave’s report being premised upon
information supplied by the parents, without discussing the medical records at all, that opinion is
rejected as without factual predicate.” Id. at *2 (citation omitted). Thus, in 2010 Dr. Cave was
made aware of the necessity to substantiate her factual allegations in Vaccine Act cases by citing
the medical records, but nevertheless, she failed in this regard in this case. In another case, the
presiding special master observed that “[d]ue to ‘a lack of documentary support for the factual
allegations’ in Dr. Cave’s report, the special master ordered petitioners to file a supplemental
report, referencing the exhibit and page number of records supporting her factual assertions.”
Blake v. HHS, No. 03-031V, 2014 WL 2769979, at *3 (Fed. Cl. Spec. Mstr. May 21, 2014),
describing an order issued in that case in 2011.
In the present case, despite the criticisms of Dr. Cave in other cases in 2010 and 2011,
described in the paragraph above, Petitioners’ counsel filed reports by Dr. Cave containing
allegations that HH had suffered seizures, a “Table encephalopathy,” and developmental
regression, that are not supported by the medical records. (See Ex. 10-a, filed Jan. 16, 2012.)
Special Master Campbell-Smith addressed those deficiencies in detail (see Orders filed Mar. 3,
2012 and April 8, 2013), but Dr. Cave persisted in relying upon some of the same
unsubstantiated factual allegations.
Thus, Dr. Cave’s pattern, of repeatedly offering testimony based upon factual allegations
that appear contrary to the medical records, gives me another good reason to question her
credibility, in general.

22
 More importantly, specifically in this case, Dr. Cave based her opinion, both as to the
“Table Injury encephalopathy” that HH allegedly suffered, and as to the allegation that HH’s
vaccinations of August 26, 2005, “caused-in-fact” or aggravated HH’s neurodevelopmental
disorder, in large part on the following assumption of fact: that HH experienced a “severe
adverse event,” including “seizures” and a dramatic alteration in her development (“slowness,
not grabbing objects, not pushing up on her arms, no attempts to crawl, poor coordination, and
[poor] eye contact” - - Tr. 15) within a day after her vaccinations of August 26, 2005. (Ex. 10, p.
1; Tr. 15.)
However, HH’s medical records contradict Dr. Cave’s assumption that HH experienced
seizures, a “severe adverse event,” or a dramatic change in her development within the 24-hour
period post-vaccinations. To the contrary, the records indicate that HH was not brought to any
health provider until 12 days later, on September 7, 2005. And at that September 7 visit her
mother did not report that HH had displayed any seizure-like behaviors, or experienced either a
severe adverse event or a sudden behavioral change, either within 24 hours of the vaccinations
on August 26, or at any time in the meantime. Instead, HH’s mother reported on September 7
only that HH had been experiencing some congestion, a “runny nose,” and fever “off and on,”
for the previous 1½ weeks. (Ex. 2, p. 9.)
I conclude that if HH had actually suffered seizures, a “severe adverse event,” and/or a
dramatic behavioral change in the day following the vaccinations, her parents (1) would have
immediately sought medical assistance, and/or (2) would have reported those symptoms to HH’s
doctor during the visit of September 7, 2005. Therefore, in light of the medical record made on
September 7, 2005, combined with the lack of any medical treatment between August 26 and
September 7, I conclude that Dr. Cave is relying on a mistaken assumption as to HH’s symptom
history.
To be sure, HH’s parents have supplied affidavits, stating that HH suffered “convulsions”
two hours after a “Hepatitis B shot,” apparently referring to one of the vaccinations of August
26, 2005. (Exs. 3 and 4.) The virtually identical affidavits of the two parents also state that HH
“continued to have convulsions on about 7 to 8 occasions later” (although it was not made clear
whether “later” meant later that day, or some other time). (Id.)21 However, for the reasons stated
in the prior paragraph, I cannot credit those affidavits over the contrary inferences that flow
inevitably from the medical record made on September 7, 2005, discussed above.
In this regard, I also note that my own finding is supported by the prior-stated analysis of
then-Special Master Campbell-Smith, who noted that HH’s medical records do not support the
factual assumptions upon which Dr. Cave based her opinions. (See Orders filed Dec. 12, 2011,
March 12, 2012, July 6, 2012.)

21
I also note that Dr. Wiznitzer opined concerning the allegation that HH suffered from “seizures,” and concluded
that there is no evidence that HH ever suffered from seizures. (Ex. A, p. 13.)

23
 VIII
PETITIONERS’ “TABLE ENCEPHALOPATHY” CLAIM
Petitioners argue that HH suffered a “Table Injury encephalopathy,” and that, therefore,
her case “benefits from a statutorily-prescribed, rebuttable presumption of causation.” (See Pet.
Post-Hearing Memorandum (“Pet. Brief”), filed Sept 8, 2014, p. 9.) However, the record as a
whole, particularly the contemporaneous medical records, make it clear that HH did not suffer a
“Table Injury encephalopathy” in temporal proximity to the vaccinations administered on August
26, 2005.

A. The applicable definition of a “Table encephalopathy”
For Vaccine Act petitions, such as this one, filed after the modifications to the Vaccine
Injury Table that went into effect on March 24, 1997, “encephalopathy” exists as a Table Injury
for DTaP vaccinations. I will set forth the relevant Table Injury definition below.22

§ 100.3 Vaccine injury table.

(a) In accordance with section 312(b) of the National Childhood Vaccine
Injury Act of 1986, * * * the following is a table of vaccines, the injuries,
disabilities, illnesses, conditions, and deaths resulting from the administration of
such vaccines, and the time period in which the first symptom or manifestation of
onset or of the significant aggravation of such injuries, disabilities, illnesses,
conditions, and deaths is to occur after vaccine administration for purposes of
receiving compensation under the program:

VACCINE INJURY TABLE

Vaccine Illness, disability, Time period for first
injury or condition symptom or manifestion
covered of onset or of significant
aggravation after vaccine
administration

* * *

Vaccines A. Anaphylaxis or 4 hours
containing anaphylactic shock
whole 72 hours

22
The statute itself contains a version of the Vaccine Injury Table that applied to vaccinations administered prior to
the enactment of the Program and for several years after that enactment. See § 300aa-14(a). However, the Vaccine
Injury Table was administratively modified with respect to Program petitions, such as this one, that were filed after
March 24, 1997. See 62 Fed. Reg. 7685, 7688 (1997); O’Connell v. Shalala, 79 F.3d 170 (1st Cir. 1996). That
Table modification, along with an earlier administrative modification of the Table in 1995 (see 60 Fed. Reg. 7694
(1995)), significantly altered the “Table Injury” categories with respect to the MMR vaccination from the version of
the Table contained in the statute. The portion of the revised Table applicable to this case, listing “encephalopathy”
as a Table Injury for the DTaP vaccination, appears at 42 C.F.R. § 100.3(a)(III)(B) (2015 edition of C.F.R.).

24
 pertussis B. Encephalopathy
bacteria, (or encephalitis) Not applicable
extracted or C. Any acute
partial cell complication or
pertussis sequela (including
bacteria, or death) of an illness,
specific disability, injury,
pertussis or condition
antigens (e.g. referred to above
DTP, DTaP, which illness,
P, DTP-Hib). disability, injury,
or condition arose
within the time
period prescribed

* * *

(b) Qualifications and aids to interpretation.23 The following qualifications
and aids to interpretation shall apply to the Vaccine Injury Table to paragraph (a)
of this section:

* * *

(2) Encephalopathy. For purposes of paragraph (a) of this section a vaccine
recipient shall be considered to have suffered an encephalopathy only if such
recipient manifests, within the applicable period, an injury meeting the description
below of an acute encephalopathy, and then a chronic encephalopathy persists in
such person for more than 6 months beyond the date of vaccination.

(i) An acute encephalopathy is one that is sufficiently severe so as to require
hospitalization (whether or not hospitalization occurred).

(A) For children less than 18 months of age who present without an
associated seizure event, an acute encephalopathy is indicated by a significantly
decreased level of consciousness lasting for at least 24 hours. Those children less
than 18 months of age who present following a seizure shall be viewed as having
an acute encephalopathy if their significantly decreased level of consciousness
persists beyond 24 hours and cannot be attributed to a postictal state (seizure) or
medication.

* * *

23
Qualifications and Aids to Interpretation (QAI). One section of the Vaccine Injury Table, 42 C.F.R. § 100.3(b),
contains definitions for the terms used in the Table. See Althen v. HHS, 58 Fed. Cl. 270, 280 (2005), aff’d, 418 F.3d
1274 (Fed. Cir. 2005) (noting that the QAI should be used to interpret key terms found in the Table).

25
 (D) A “significantly decreased level of consciousness” is indicated by the
presence of at least one of the following clinical signs for at least 24 hours or greater
(see paragraphs (b)(2)(i)(A) and (b)(2)(i)(B) of this section for applicable
timeframes):

(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 upon
family members or other individuals); or

(3) Inconsistent or absent responses to external stimuli (does not
recognize familiar people or things).

(E) The following clinical features alone, or in combination, do not
demonstrate an acute encephalopathy or a significant change in either mental status
or level of consciousness as described above: Sleepiness, irritability (fussiness),
high-pitched and unusual screaming, persistent inconsolable crying, and bulging
fontanelle. Seizures in themselves are not sufficient to constitute a diagnosis of
encephalopathy. In the absence of other evidence of an acute encephalopathy,
seizures shall not be viewed as the first symptom or manifestation of the onset of
an acute encephalopathy.

* * *

(ii) Chronic Encephalopathy occurs when a change in mental or neurologic status,
first manifested during the applicable time period, persists for a period of at least 6
months from the date of vaccination.

42 C.F.R. § 100.3 (2015 edition of C.F.R.).

Thus, to establish their Table Encephalopathy claim, under the regulatory language set
forth above, Petitioners must demonstrate that HH manifested an injury encompassed in the
definition of an “acute encephalopathy” within 72 hours of her DTaP vaccination, and that a
“chronic encephalopathy” was then present for more than 6 months after the acute
encephalopathy. 42 C.F.R. § 100.3(b)(2).

For a child younger than 18 months, presenting without an associated seizure event, an
acute encephalopathy is, as set forth above, indicated “by a significantly decreased level of
consciousness . . . lasting for at least 24 hours.” § 100.3(b)(2)(i)(A). A significantly decreased
level of consciousness is demonstrated by the presence of one of three clinical signs for a period
of at least 24 hours: “(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 upon family
members or other individuals); or (3) Inconsistent or absent responses to external stimuli (does
not recognize familiar people or things).” § 100.3(b)(2)(i)(D). Sleepiness, irritability (fussiness),
high-pitched and unusual screaming, persistent inconsolable crying, and bulging fontanelle are
not, alone, or in combination, a demonstration of an acute encephalopathy. § 100.3(b)(2)(E).
26
An acute encephalopathy is an event “that is sufficiently severe so as to require hospitalization
(whether or not hospitalization occurred).” § 100.3(b)(2)(i).24

A chronic encephalopathy is defined in the QAI as “a change in mental or neurologic
status, first manifested during the applicable time period, [that] persists for a period of at least 6
months from the date of vaccination.” § 100.3(b)(2)(ii).

The clinical signs and symptoms of an acute encephalopathy were incorporated into the
QAI to “clearly distinguish infants and children with brain dysfunction from those with transient
‘lethargy.’” Revision of the Vaccine Injury Table, 60 Fed. Reg. at 7687. As noted in Waddell,
by then-Chief Special Master Campbell-Smith,25 the QAI definition of “significantly decreased
level of consciousness” implies “a state of diminished alertness that is much more than mere
sleepiness or inattentiveness . . . . [It] requires markedly impaired--or strikingly absent--
responsiveness to environmental or external stimuli, for a sustained period of at least twenty-four
hours.” Waddell v. HHS, No. 10-316V, 2012 WL 4829291, at *7 (Fed. Cl. Spec. Mstr. Sept. 19,
2012). Special Master Campbell-Smith added that the symptoms of a “Table Injury
encephalopathy” are not “subtle.” Id. at 6.

B. Petitioners’ failed to demonstrate a “Table Injury encephalopathy” in this case.
Based on my own review of the contemporaneous medical records, it is absolutely clear
that HH did not suffer an “acute encephalopathy” that would satisfy the above definition of a
“Table encephalopathy.” Such contemporaneous records have more evidentiary weight than
retrospective accounts recorded months later.26

As explained in detail above, HH’s parents supplied affidavits indicating that HH
suffered “convulsions” about two hours after her vaccination of August 26, 2005. (Exs. 3-4).
But, as also explained above, based on the only contemporaneous medical record, the notation
recorded on September 7, 2005, I cannot credit those affidavits in that regard. (See the
discussion at Section VII(C) of this Decision above.)

Similarly, the medical records offer no support whatsoever to the Petitioners’ claim that
HH suffered an “acute encephalopathy” as described in the regulatory “Table encephalopathy”
definition set forth at Section VIII(A) above. The record of September 7, 2005, gives no
indication that HH suffered a seizure or a “significantly decreased level of consciousness.”

24
When the QAI definition was revised, it was noted that the hospitalization requirement was not intended “as an
absolute requirement to establish an acute encephalopathy, but rather as an indicator of the severity of the acute
event.” Revision of the Vaccine Injury Table, 62 Fed. Reg. 7685, 7687 (Fed. 20, 1997) (preamble to final rule).
25
On September 19, 2013, Chief Special Master Campbell-Smith was appointed Judge of the U.S. Court of Federal
Claims. On October 21, 2013, Judge Campbell-Smith was designated as the Chief Judge of the U.S. Court of
Federal Claims.
26
“Medical records, in general, warrant consideration as trustworthy evidence. The records contain information
supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper
treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous
to the medical events.” Cucuras v. HHS, 993 F.2d 1525, 1528 (Fed. Cir. 1993.)

27
 In this regard, see also the testimony of Dr. Wiznitzer, who similarly concluded that there
is nothing in HH’s medical records indicating that she suffered an acute encephalopathy within
the Table definition. (Tr. 86-87, 133-35.)27

To be sure, in the medical record made on September 7, 2005, there is a notation of
“sleep↑,” indicating that sometime between August 26 and September 7, HH’s sleep increased at
least to some degree. (Ex. 2, p. 9.) But some increase in sleep certainly does not rise to the level
of showing the type of “significantly decreased level of consciousness” required by the
regulatory definition set forth above. Dr. Wiznitzer so interpreted that record. (Tr. 86-87.)
Further, the regulatory definition itself states plainly that “sleepiness” does “not demonstrate an
acute encephalopathy or a significantly change in * * * level of consciousness.” 42 C.F.R. §
100(3)(E) (10-1-97 edition of C.F.R.) (emphasis added).

Therefore, I conclude that Petitioners have failed, by far, to demonstrate that HH suffered
a “Table Injury encephalopathy” within the 72 hours after her DTaP vaccination of August 26,
2005.

IX
PETITIONERS HAVE ALSO FAILED TO DEMONSTRATE THAT VACCINATIONS
PLAYED ANY ROLE IN EITHER INITIALLY CAUSING, OR AGGRAVATING,
HH’s NEURODEVELOPMENTAL DISORDER
Sadly, as noted above, HH has suffered from a severe neurodevelopmental disorder,
which has been diagnosed as falling within the category of an Autistic Spectrum Disorder. (E.g.,
Ex. 22, pp. 1, 8, 21.) However, Petitioners have failed completely to demonstrate that HH’s
vaccinations of August 26, 2005, played any role in either initially causing, or aggravating, that
neurodevelopmental disorder.

A. Dr. Cave’s causation opinion was based upon the assumption of alleged occurrences
not substantiated by the medical records.

As explained in detail above, Dr. Cave based her opinion as to “actual causation,” just like
her opinion that HH suffered a “Table Injury encephalopathy, on the assumption that HH
experienced a “severe adverse event,” including “seizures” and a dramatic alteration in her
development, within 24 hours of her vaccinations of August 26, 2005. But as explained above, I
have rejected Dr. Cave’s factual assumption in that regard as plainly wrong, so that her causation
conclusions must be rejected for that reason alone. (See Section VII(C) above.)

27
In their Post-Hearing Memorandum, Petitioners rely upon a written report concerning HH’s alleged reaction to the
vaccinations of August 26, 2005, which they filed into the “VAERS”--Vaccine Adverse Event Reporting System.
(Post-Hearing memo, p. 9.) However, the VAERS report submitted by Petitioners was not dated until February 11,
2006. (Ex. 11, p. 2.) I find the actual medical record made on September 7, 2005 (Ex. 2, p. 9) to be a more
accurate report of what symptoms HH did or did not display in the days immediately after the August 2005
vaccinations then a report submitted nearly six months later, after HH’s developmental delay had become apparent.

28
B. Dr. Cave erroneously discounted the fact that HH was suffering from her
neurodevelopmental disorder prior to the vaccinations of August 26, 2005.

On March 2, 2012, the then-presiding Special Master Campbell-Smith filed an order in this
case stating that “the evidence suggests that [HH’s] neurodevelopmental injury was already
underway prior to the administration of the vaccines at issue here.” (Order, filed Mar. 2, 2012,
pp. 5-6.) This suggestion was based on a series of head circumference measurements performed
during HH’s infancy, which were later analyzed by a treating pediatric neurologist of HH, Dr.
Robert Cruse. On June 26, 2006, Dr. Cruse recorded the following assessment of HH:

Of concern is that her head circumference has decreased over time and crossed
percentile lines; it was initially at the 50th percentile up to about 3 months of life
* * *.

(Ex. 14, p. 9, emphasis added). Therefore, Dr. Cruse’s opinion was that a significant brain
abnormality in HH became evident soon after age three months, and thus likely before the
vaccinations here in question. Similarly, on March 19, 2007, Dr. Duane Superneau, a treating
geneticist of HH, opined that the “microcephaly [abnormally small head and brain size] in [HH]
has been present from prior to the immunizations which have been implicated by the mother as
potentially complicating [HH’s] clinical course.” (Ex. 14, p. 11.) Dr. Superneau concluded that
HH’s “physical findings suggested the problems existed from birth, consistent with the majority
of problems of this type.” (Id.)
Dr. Cave contended that both of these treating medical specialists, Drs. Superneau and
Cruse, misinterpreted the available data concerning HH’s head growth. (Ex. 10-b, p. 9.)
During the trial, Dr. Cave testified that she had re-analyzed the various head measurements in
the medical records, and concluded that HH’s head size was roughly at the 5th percentile at
birth, and her rate of head growth thereafter was about the 5th to the 7th percentile. (Tr. 11.)
“She’s small, and she has a small head.” (Id.) Dr. Cave concluded that “the evidence does not
suggest that [HH’s] developmental injury was already underway prior to the administration of
the vaccines at issue here.” (Ex. 10-b, p. 10, emphasis in original.)
Respondent’s expert Dr. Wiznitzer, however, testified that HH was microcephalic,
meaning a significantly abnormally small head size, a sign of an abnormal brain development.
(Tr. 85.) Moreover, he performed an analysis of HH’s medical records and concluded that she
had an abnormal head circumference prior to the vaccinations in question. (Ex. A, pp. 9, 12-
13.) Dr. Wiznitzer concluded that HH displayed “a slowing of head circumference growth
[that] reflects a slowing of brain growth that predated the 8/26/05 vaccinations.” (Ex. A, p. 12.)
Dr. Wiznitzer reiterated this analysis at the trial. (Tr. 79-85).
In analyzing this issue, I have studied the contemporaneous medical notations, the
experts’ opinions, and the various growth charts submitted in evidence by both parties. I note
that two different treating doctors of HH--one pediatric neurologist (Dr. Cruse) and one
geneticist (Dr. Superneau)--have opined that onset of HH’s microcephaly pre-dated her
vaccinations of August 26, 2005, and probably contributed to her subsequent
neurodevelopmental problems. (Ex. 14, pp. 9, 11.) Respondent’s well-qualified medical expert,
Dr. Wiznitzer, also a pediatric neurologist, reached the same conclusion. To be sure, Dr. Cave, a
family practitioner, opined that all three of those specialists were not correct. However, I find

29
that the persuasive weight of the opinions of those three highly qualified doctors is supported by
multiple growth charts showing that HH’s head size (and therefore brain size), in comparison to
other infants, was abnormally small well before the vaccinations of August 26, 2005.

Dr. Cave argued that HH’s head circumference measurements “started out in the 5th
percentile at birth and two years later ended up at the 5th percentile.” (Ex. 27, p. 5.) During the
trial she re-stated this argument. (Tr. 11.) When I reviewed the medical records as Dr. Cave
suggested, I found that HH had a head circumference notation of 12½ inches (31.75 cm) at birth
(see Ex. 1, p. 8), which appears to register on the pediatric growth charts as the 5th percentile or
less, as alleged by Dr. Cave. However, I also noted Dr. Wiznitzer’s opinion that a head
measurement taken immediately after birth is often distorted by compression of the infant’s skull
during the birthing process, and that measurements taken at two weeks of age are considered
more accurate.28 (Tr. 80.) Measurements were, in fact, recorded at two weeks of age and
regularly thereafter, by Dr. Chatters, HH’s first pediatrician. (Ex. 2, pp. 47-50.) Using either of
the standard growth charts submitted in this case,29 none of Dr. Chatters’ head circumference
measurements (Ex. A) is close to the 5th percentile, as Dr. Cave alleged.

Apparently, Dr. Cave’s assessment of the first few months of HH’s life excluded all of
the head measurements performed by HH’s first pediatrician, Dr. Chatters, and emphasized only
the measurement of 31.75 cm at birth. (See Ex. 1, p. 8; Tr. 84). This maneuver by Dr. Cave
concealed the significant deceleration of HH’s head growth rate during infancy, which was
described by both the treating pediatric neurologist, Dr. Cruse (Ex. 14, p. 9), and Respondent’s
expert witness, Dr. Wiznitzer (Ex. A, p. 12). Both of these pediatric neurologists diagnosed
“microcephaly” (abnormally small head size) with an onset that preceded HH’s vaccinations of
August 26, 2005. Dr. Cave’s testimony did nothing to persuade me otherwise.

Dr. Wiznitzer also pointed out more evidence in HH’s medical records, in addition to the
head circumference data, indicating that HH was likely developmentally delayed prior to the
vaccinations in question. (See Tr. 72-74, 75-77.)

Accordingly, in this case I find further reason to conclude that the vaccinations of August
26, 2005, did not initially cause HH’s neurodevelopmental problems, because the evidence
concerning HH’s microcephaly shows that her “neurodevelopmental injury was already
underway prior to the administration of the vaccines at issue here,” (quoting the Order of
Special Master Campbell-Smith, filed on Mar. 2, 2012). Further, Dr. Cave’s misanalysis of
HH’s pre-existing microcephaly and other evidence of HH’s pre-existing delay adds additional
reason to doubt the credibility of Dr. Cave’s overall causation theory in this case.

28
At birth, HH’s head circumference measured 12½ inches (31.75 cm); while at two weeks of age, her head
measured 35 cm. (Ex. 1, p. 8; Ex. 2, p. 47.) Thus, in the first two weeks of her life, HH’s head circumference
apparently “grew” a total of 3.25 cm. This large amount of “growth” seems unlikely. Dr. Wiznitzer’s explanation
that HH’s initial birth measurement was actually reduced by compression during birthing seems more likely.
29
The growth charts referenced in this discussion are located at Ex. 2, p. 43, and Ex. A, pp. 16, 17.

30
C. “Mitochondrial dysfunction” and the Morava Criteria
In this regard, I note that Dr. Cave’s theory that HH’s vaccines either “initially caused,”
or “significantly aggravated,” HH’s neurodevelopmental disorder rests on the argument that HH
suffered from a “mitochondrial dysfunction” that allegedly made her more vulnerable to
neurologic injury by toxins contained in vaccines, particularly aluminum. (Ex. 27, p. 4; Tr. 19;
46-47.) Consequently, there was extensive discussion in the parties’ expert reports and hearing
testimony concerning whether HH suffered from “mitochondrial disorder” and/or “mitochondrial
dysfunction,” based on certain criteria elaborated by Morava, et al.30 (“Morava article”) (See Ex.
10-b, pp. 6-7; Ex. 27, pp. 1-7; Ex. A, pp. 11-13; see also Tr. 23-33; Tr. 90-95.) The Morava
article, in turn, acknowledged its reliance on the consensus mitochondrial disease criteria scoring
system proposed by Wolf and Smeitink31 (“Wolf article”), with particular emphasis on the
“General Criteria” found in an attachment to that article.32

To summarize, my analysis of this issue shows that Dr. Cave’s analysis was fatally
flawed in yet another respect, and was far inferior to that of Dr. Wiznitzer.

In analyzing this issue, I note first that the parties’ experts both claim that they relied on
the Morava article to assess HH’s condition, yet they reached completely opposite conclusions.
Second, I note that Petitioners’ expert, Dr. Cave, declined to utilize the terminology employed by
these articles (i.e., “mitochondrial disorder”) in her reports and testimony, and chose instead to
generally use the expression “mitochondrial dysfunction.” (E.g., Ex. 10, p. 1; Ex. 10-a, p. 2; Ex.
10-b, p. 5; Ex. 27, pp. 1-3; Tr. 17-18, 38, 61.) In my analysis, I will generally employ the term
used in the defining articles, that is, “mitochondrial disorder.”
1. Dr. Cave’s understanding of mitochondrial disorders and the Morava
criteria seemed highly questionable.

Dr. Cave contended that Respondent’s expert, Dr. Wiznitzer, does not understand “how
to interpret laboratory tests that are pertinent to the [Morava] criteria.” (Ex. 27, p. 1.)33 Rather,
she argued that this is her own “field of expertise,” because she possesses a “Master of Science
Degree in Clinical Chemistry.” (Id.)
I found, however, that in her testimony, it was Dr. Cave who often demonstrated a lack of
knowledge about that subject matter. For example, she explained that “I’ve done quite a bit of

30
E. Morava, et al., Mitochondrial Disease Criteria: Diagnostic Applications in Children, 67 Neurology 1823-26
(2006), filed as Respondent’s Ex. C, on October 5, 2012. Petitioners filed an abstract of this article twice: as an
attachment to Ex. 10-a (pp. 15-17) on Jan. 16, 2012; and as Ex. 25, on June 27, 2012. Eighteen months later, on
January 14, 2014, Petitioners filed a copy of the original Morava article, identified as Exhibit 28.
31
Nicole I. Wolf and Jan A.M. Smeitink, Mitochondrial Disorders: A Proposal for Consensus Diagnostic Criteria
in Infants and Children, 59 Neurology 1402-05 (2002), filed by Respondent as Ex. D, on Oct. 5, 2012.
32
Nicole I. Wolf and Jan A.M. Smeitink, Mitochondrial Disorders: The Mitochondrial Disease Criteria – General
Criteria, an attachment to the above-cited article, filed by Respondent as Ex. E, on Oct. 5, 2012.
33
According to Dr. Cave, Respondent’s expert “did not bring to this case a working knowledge of how to interpret
Laboratory tests, which are necessary to define the mitochondrial dysfunction.” (Ex. 27, p. 6.)

31
CME [continuing medical education] activity in the field of toxicology and heavy metal
toxicology” (Tr. 9), and, when explaining that her theory of causation implicates aluminum as an
injurious component of vaccines, she asserted that “aluminum itself is a heavy metal and it’s
destructive” (Tr. 19; see also Tr. 51). However, when Dr. Wiznitzer was asked whether
aluminum was a heavy metal, he replied that it was not, “it’s actually light.” (Tr. 88.) In this
matter, as in many others, I found Dr. Wiznitzer’s opinion to be more informed. That is, “heavy
metal” means “one with a high specific gravity, usually defined as being above 5.0.” Dorland’s
Illustrated Medical Dictionary (31st ed. 2007), p. 1161. Aluminum has a specific gravity of
2.699 (id., p. 56), placing it outside, contrary to Dr. Cave’s assumption, the category of “heavy
metals.”

Moreover, Dr. Cave also seemed to misunderstand the Morava article and the Morava
criteria, as I will demonstrate in detail in the next section of this Decision.

2. Dr. Wiznitzer’s application of the Morava criteria to HH’s case was much
more persuasive than that of Dr. Cave.

It is important to examine the specific content of the Morava article as it pertains to the
contrasting opinions of Drs. Cave and Wiznitzer. The Morava article sets forth a diagnostic
scoring system to identify mitochondrial disorders. (Ex. C, see also the Wolf article, Ex. D.)
According to the authors of the Morava article, the Morava criteria can and should be applied in
clinical situations where mitochondrial disease is suspected but not yet confirmed by a muscle
biopsy. (Ex. C, p. 1; Ex. D, p. 3.) No muscle biopsy was performed on HH, so the criteria
appear to apply directly to this case.

The system set forth in these articles requires assessment in three major diagnostic
Sections: I – clinical signs and symptoms; II – metabolic/imaging studies; and III –
morphology/histopathology. (Ex. C, pp. 1-2; Ex. D, pp. 1-2; see also Tr. 91-92.) In devising this
system, the authors allotted points for each symptom exhibited by a patient, but capped the total
amount of scoring in each of these three Sections at four points, resulting in a maximum possible
score of twelve (12) points when the three sections are combined. (Ex. D, p. 1.) This explicit
limitation was meant to avoid giving unreasonable diagnostic weight to multiple symptoms that
may present together within a particular section. (Ex. D, pp. 1-2.)34 It is notable that the criteria
included within Section III (morphology/histopathology) are used only when the results of a
muscle biopsy are available. (Ex. C, p. 2.) No muscle biopsy was performed on HH. Thus,
without results from a muscle biopsy test, the total maximum score would amount only to eight
points. These diagnostic scoring limitations are carefully reiterated in the Morava article (Ex. C,
pp. 2-3), and in the table appended to the Wolf article (Ex. E).

The first major Section (I--Clinical signs and symptoms) is further divided into three
categories with specific point limitations: A – Muscular presentation (2 points); B – Central
nervous system presentation (2 points); Multisystem disease (3 points). (Ex. C, pp. 1-2; Ex. F,

34
“In order to avoid disproportionate contribution from a multitude of single clinical, metabolic, imaging, or
morphologic criteria to the scoring for a given patient, we capped the number of points that could be achieved for
each section. Thus clinical presentation, metabolic investigations and imaging, and histopathology can each
contribute a maximum of four points.” (Ex. D, pp. 2-3.)

32
pp. 2-5; see also Ex. 25, pp. 3-4; Tr. 91-92.) Thus, the points assigned to categories A, B, and C
could reach a possible total of seven points, when considered separately, but when combined
together in Section I, the authors deliberately restrict the total to only four points. (Ex. C, pp. 2-
3.) Likewise, in Section II (Metabolic/imaging studies), there are various individual components
that may be assigned one or two points, which would result in a potential total of 17 points if all
of them were present; however, the authors will allow a total score of only four points, no matter
how many of the individual laboratory test results are present. (Id.)
Dr. Cave discussed application of the Morava criteria in her supplemental expert reports.
(See Ex. 10-a, p. 2; Ex. 10-b, pp. 4-6.) In the first supplemental report, she calculated that HH
exceeded “the highest score on Morava’s 2006 Criteria for Mitochondrial Disorder – above 12.”
(Ex. 10-a, p. 2.) In the second supplemental report, she calculated a total score of 14 points. (Ex.
10-b, p. 6.) During the hearing, Dr. Cave revised her calculations to reach a total of 9 or 10
points. (Tr. 31-32.) It is notable that for each of these estimates, points were not included for
category III, because there were no muscle biopsy results. Thus, the points allowed for Sections
I and II under the Morava criteria without a muscle biopsy, by the very definition set forth in the
Morava article itself, could reach a maximum total of only 8 points. Yet all of Dr. Cave’s various
calculations, incongruously, exceeded the maximum allowed by the Morava criteria.
This is not surprising. Dr. Cave’s diagnosis of a mitochondrial “dysfunction” is achieved
by tabulating all the points available in the major Sections identified in the Morava and Wolf
articles (regarding mitochondrial disorders), but without applying any of the limitations required
by the articles. (See Tr. 90.) Respondent’s witness, Dr. Wiznitzer, observed that Dr. Cave’s
total score of 14 was “impossible, because there’s defined rules for how many points you can
apply per section of the criteria … [a]nd unfortunately, it appears that … the specific instructions
were not followed to achieve [Dr. Cave’s] score of 14.” (Id.) The same criticism can be applied
to all of Dr. Cave’s assessments totaling between 9 and 14 points, allegedly based on the Morava
criteria. Dr. Cave has simply not adhered to the methods described in the Morava and Wolf
articles.
The Morava article presents the consensus mitochondrial disease criteria, a methodology
that imposes strict limitations on scoring relevant symptoms for the purpose of making a
diagnosis. The authors wanted an analytical methodology that was not impeded by “the lack of
agreement on optimal biochemical assays and cut-off values” related to diagnosing
mitochondrial disorders. (Ex. C, p. 1.) This goal is stated explicitly in the first sentence of the
article. Yet, in Dr. Cave’s expert reports and in her trial testimony, there are many pages of
discussion concerning optimal biochemical assays and cut-off values. This is precisely what
the authors stated that they wished to avoid when making this type of diagnosis. Dr. Cave
asserted that she relied on this article, but she refused to accept the underlying premises
articulated by the authors.
Dr. Cave appears to have attempted to obscure her refusal to accept the Morava article’s
underlying premises, by her insistence that HH suffers from a mitochondrial “dysfunction,”
rather than a mitochondrial “disorder” (Ex. 10-b, p. 5),35 which, she seemed to assert, allows her

35
“The first thing that I want to clear up is that I did not use the term ‘mitochondrial disorder’ in my report. I found
evidence *** that [HH] had significant mitochondrial dysfunction.” (Ex. 10-b, p. 5.)

33
to select only those aspects of the Morava article that are useful to her argument. In her final
expert report, she spoke exclusively of HH’s mitochondrial “dysfunction.” (Ex. 27, pp. 1, 4, 6.)
In her testimony, she also insisted that mitochondrial “dysfunction” is the appropriate diagnosis,
but acknowledged that her diagnosis in this case has never been confirmed by a mitochondrial
disease specialist.36 However, when discussing the final “score” that Dr. Cave presented at trial
(that is, “9”), she argued that her calculations meant that HH had “a definite mitochondrial
disorder.” (Tr. pp. 32-33.) When questioned about this, Dr. Cave reiterated: “I don’t think
there’s a chance [HH] doesn’t have a mitochondrial disorder, and I think by the criteria we use,
it’s a definite. I don’t think – I don’t think that’s even a question.” (Tr. 62.) This assertion of a
mitochondrial “disorder” in HH seems to be a contradiction of Dr. Cave’s previous
characterization of mitochondrial “dysfunction.” Moreover, this late assertion that HH suffered
from a mitochondrial “disorder” demonstrates that Dr. Cave was mistaken in failing to utilize
the actual methodology used by Morava and Wolf in their articles published in the
distinguished medical journal, Neurology. Dr. Cave’s analytical method clearly contradicts the
premises of those articles. Thus, I find that her opinion that HH suffered either a mitochondrial
“disorder” or a “dysfunction” is not reliable.

3. Dr. Wiznitzer’s testimony concerning mitochondrial disorders and the
Morava criteria was logical and persuasive.

In contrast to the vagueness, ambivalence, self-contradiction, and illogic of Dr. Cave’s
testimony, the testimony of Dr. Wiznitzer was coherent, consistent, and logical throughout. He
reviewed the totality of the medical records, not just selected parts, and reached a diagnosis of
microcephaly predating the vaccinations (Tr. 79-85), in concurrence with the treating pediatric
neurologist, Dr. Cruse. Further, Dr. Wiznitzer considered each of Dr. Cave’s allegations
concerning application of the Morava criteria to the facts of this case, regarding: exercise
intolerance, muscle weakness, eye problems, developmental regression, possible seizures,
constipation, and multiple laboratory test results. (Ex. A, pp. 10-12.) He concluded that Dr.
Cave had used unreliable information and/or misapplied the medical standards in all but one of
her allegations about HH’s symptoms, in relation to the Morava criteria. (Id.) That is, Dr.
Wiznitzer agreed with Dr. Cave on one issue, that HH suffered from developmental delay, and
that solitary positive criterion registered only one point on the consensus mitochondrial disease
criteria advocated by the Morava and Wolf articles. Thus, Dr. Wiznitzer, in contrast to Dr. Cave,
found that HH actually should be scored as a total of only “1” on the Morava criteria, which
would put her in the “mitochondrial disorder unlikely” category. (Ex. A, p. 12.)

Further, Dr. Wiznitzer noted that HH’s medical records do not support a diagnosis of
mitochondrial “dysfunction,” either. (Id.) The medical records do not indicate that HH was ever
even sent to a mitochondrial specialist37 for evaluation of possible mitochondrial problems, as
Dr. Cave herself was forced to admit. (Tr. 61.)

36
“Q. Have any of – have your – has your diagnosis of a mitochondrial disorder been verified by a specialist in
mitochondrial disorders?
A. I’m saying mitochondrial dysfunction. I have not sent her to a mitochondrial specialist, no.” (Tr. p. 61.)
37
Dr. Wiznitzer explained that if he had a patient whom he suspected might have a mitochondrial disorder, he would
“definitely” send such patient to a mitochondrial specialist. (Tr. 120.)

34
 I find that HH did not have a mitochondrial “disorder” or “dysfunction” that predisposed
her to injury by the vaccinations she received on August 26, 2005.
D. Dr. Cave simply never presented a logical or coherent case concerning “causation-in-
fact,” while Dr. Wiznitzer’s presentation was far more persuasive.
As noted above, Petitioners’ entire presentation concerning “causation-in-fact” has been
generally vague, unclear, often self-contradictory, and far from persuasive. As set forth above in
Section IX (A) of this Decision, Dr. Cave has relied completely upon a misassumption of fact.
As set forth in Section IX (B), she misanalyzed the evidence that shows that HH had a serious
neurodevelopmental problem prior to the vaccinations in question. As set forth in Section IX
(C), while Dr. Cave based her causation theory on the proposition that HH suffered from a
“mitochondrial dysfunction” or “mitochondrial disorder,” she in fact seriously misanalyzed the
evidence in that regard too, so that there is no good reason to believe that HH even had any type
of mitochondrial dysfunction or disorder.

Finally, I note again that even if one were to assume for the sake of argument, that HH
did suffer from some kind of mitochondrial dysfunction or disorder, Dr. Cave made no serious
attempt to explain why such a circumstance would therefore tend to show that vaccinations either
initially caused or aggravated HH’s neurodevelopmental disorder. Dr. Cave did not present any
explanation of her theory that the presence of “mitochondrial dysfunction” would make an infant
more susceptible to the unspecified “toxins” in unspecified vaccines. She simply did not explain
her theory in this regard in any detail. Dr. Cave merely seemed to assume that the presence of
“mitochondrial dysfunction” would render an infant more susceptible to purported vaccine-
related damage. But she presented no persuasive reason why I should adopt such an
assumption.38 (And Dr. Wiznitzer testified to the contrary. Tr. 132.)
E. Summary concerning “causation-in-fact” allegations
To be sure, I do not have any reason to doubt that Dr. Cave is a competent clinical
practitioner in her field. My conclusion is simply that, in general, the presentation of Dr.
Wiznitzer in this case was far more persuasive than that of Dr. Cave, as to all points. I thus
conclude, for all the reasons set forth above, that Petitioners have failed to demonstrate that it is
“more likely than not” that the vaccinations of August 26, 2005, either initially caused, or
aggravated, HH’s tragic neurodevelopmental disorder.39

38
I am aware of the recent opinion Paluck v. HHS, 786 F.3d 1373 (Fed. Cir. 2015), in which the Federal Circuit
Court of Appeals concluded that a child’s pre-existing mitochondrial disorder was significantly aggravated by his
receipt of the MMR, varicella, and pneumococcal vaccines. However, the facts of that case, as well as the vaccines
involved, were quite different from the circumstances here. HH did not have a mitochondrial disorder diagnosis, nor
did HH manifest any exacerbation of her condition within a proximate temporal relationship to the vaccinations.
39
Dr. Cave also asserted very briefly that HH may have suffered from two “genetic mutations,” suggesting that such
mutations may have “compromised” HH’s ability to clear the aluminum adjuvant in the vaccine from her system.
(Ex. 27, p. 5; Tr. 18-19.) But Dr. Cave never explained in any detail why she believes that the existence of these
mutations might have any relevance to Dr. Cave’s overall causation theory. Dr. Wiznitzer, on the other hand,
persuasively explained why there is no evidence that such genetic mutations had any effect on HH’s
neurodevelopmental disorder. (Tr. 120-27.)
Dr. Cave also briefly mentioned an article by Poling, et al., suggesting that the article “discusses the
possible links between the developmentally disabled and mitochondrial dysfunction.” (Ex. 10-b, p. 6; Ex. 27, pp. 3-

35
 X
PETITIONERS’ CASE FAILS THE TESTS REQUIRED BY ALTHEN AND
LOVING
In this part of my Decision, I will explain how this case fits specifically within the
interpretive standards set forth in the Althen and Loving decisions. The short answer is that I find
that Petitioners’ case clearly does not satisfy the standards presented in either Althen or Loving.
In this regard, as previously noted, Petitioners’ presentation in this case has been so
jumbled and poorly explained that it is not even clear whether they are ultimately contending (1)
that the vaccinations of August 2005 initially caused HH’s neurodevelopmental disorder, or (2)
that those vaccinations significantly aggravated a preexisting neurodevelopmental disorder.
That does not matter to the outcome of this case, since it is clear that Petitioners have clearly
failed to show either. But, in this Section of my Decision, I will, therefore, analyze Petitioners’
case first under Althen, assuming that they are raising an “initial causation” argument. Then I
will analyze Petitioners’ case under the six-part Loving/Althen test, assuming that they are
advancing a “significant aggravation” claim.

A. Applying the Althen standard to Petitioners’ “initial causation” claim

First, I will analyze the Petitioners’ “initial causation” claim, utilizing the Althen
standard.
The U.S. Court of Appeals for the Federal Circuit declared in Althen that it is a
petitioner’s burden:
to show by preponderant evidence that the vaccination brought about her injury
by providing: (1) a medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.

Althen, 418 F.3d at 1278 (citations omitted). There can be no doubt whatsoever that the Althen
test ultimately requires that, as an overall matter, a petitioner must demonstrate that it is “more
probable than not” that the particular vaccine was a substantial contributing factor in causing or
aggravating the particular injury in question. That is clear from the statute itself, which states
that the elements of a petitioner’s case must be established by a “preponderance of the evidence.”
(§ 300aa-13(a)(1)(A).) In the pages above, of course, I have already set forth in detail my
analysis in rejecting Petitioners’ “actual causation” theory, including their “initial causation”
portion of that theory, in this case. In this part of my Decision, then, I will briefly explain how
that analysis fits specifically within the three parts of the Althen test, enumerated in the first

4; Tr. 33.) However, Dr. Cave did not discuss the article in detail, in any of her reports at the hearing. In their Post-
Hearing Memorandum, at p. 16, Petitioners did cite the article--Poling et al., Developmental Regression and
Mitochondrial Dysfunction in a Child With Autism, 21(2) J. Child Neurology 170 (2006). But the article offers no
support for Dr. Cave’s theory in this case, because, as explained above (Section IX(C)), the evidence in this case
does not show that HH suffered from any mitochondrial dysfunction or disorder.

36
sentence of the Althen excerpt set forth above. The short answer is that I find that Petitioners
“initial causation” claim in this case clearly does not satisfy the Althen test.

1. Relationship between Althen Prongs 1 and 2
One interpretive issue with the Althen test concerns the relationship between the first two
elements of that test. The first two prongs of the Althen test, as noted above, are that the
petitioners must provide “(1) a medical theory causally connecting the vaccination and the
injury; [and] (2) a logical sequence of cause and effect showing that the vaccination was the
reason for the injury.” Initially, it is not absolutely clear how the two prongs differ from each
other. That is, on their faces, each of the two prongs seems to require a demonstration of a
“causal” connection between “the vaccination” and “the injury.” However, a number of Program
opinions have concluded that these first two elements reflect the analytical distinction that has
been described as the “can cause” vs. “did cause” distinction. That is, in many Program opinions
issued prior to Althen involving “causation-in-fact” issues, special masters or judges stated that a
petitioner must demonstrate (1) that the type of vaccination in question can cause the type of
injury in question, and also (2) that the particular vaccination received by the specific vaccinee
did cause the vaccinee’s own injury. See, e.g., Kuperus v. HHS, 2003 WL 22912885, at *8 (Fed.
Cl. Spec. Mstr. Oct. 23, 2003); Helms v. HHS, 2002 WL 31441212, at *18 n. 42 (Fed. Cl. Spec.
Mstr. Aug. 8, 2002). Thus, a number of judges and special masters of this court have concluded
that Prong 1 of Althen is the “can cause” requirement, and Prong 2 of Althen is the “did cause”
requirement. See, e.g., Doe 11 v. HHS, 83 Fed. Cl. 157, 172-73 (2008); Nussman v. HHS, 83
Fed. Cl. 111, 117 (2008); Banks v. HHS, 2007 WL 2296047, at *24 (Fed. Cl. Spec. Mstr. July
20, 2007); Zeller v. HHS, 2008 WL 3845155, at *25 (Fed. Cl. Spec. Mstr. July 30, 2008). And,
most importantly, the Federal Circuit confirmed that interpretation in Pafford, ruling explicitly
that the “can it?/did it?” test, used by the special master in that case, was equivalent to the first
two prongs of the Althen test. Pafford v. HHS, 451 F.3d at 1352, 1355-56 (Fed. Cir. 2006).
Thus, interpreting the first two prongs of Althen as specified in Pafford, under Prong 1 of Althen
a petitioner must demonstrate that the type of vaccination in question can cause the type of
condition in question; and under Prong 2 of Althen that petitioner must then demonstrate that the
particular vaccination did cause the particular condition of the vaccinee in question.

Moreover, there can be no doubt whatsoever that the Althen test ultimately requires that,
as an overall matter, a petitioner must demonstrate that it is “more probable than not” that the
particular vaccine was a substantial contributing factor in causing the particular injury in
question. That is clear from the statute itself, which states that the elements of a petitioner’s case
must be established by a “preponderance of the evidence.” § 300aa-13(a)(1)(A). And, whatever
is the precise meaning of Prongs 1 and 2 of Althen, in this case the overall evidence falls far
short of demonstrating that it is “more probable than not” that any of the vaccines that HH
received on August 26, 2005, contributed to the causation of her tragic neurodevelopmental
disorder.

37
 2. Petitioners have failed to establish Prong 1 of Althen in this case

As explained above, under Prong 1 of Althen a petitioner must provide a medical theory
demonstrating that the type of vaccine in question can cause the type of condition in question.
Petitioners’ primary theory in this case seems to be that HH’s vaccinations of August 26, 2005,
in the context of an alleged “mitochondrial dysfunction” in HH, initially caused HH’s
neurodevelopmental disorder. However, as described above in Section IX, Dr. Cave has not
demonstrated that any type of vaccination can cause a neurodevelopmental disorder. Thus
Petitioners’ claim clearly fails under Althen Prong 1.

3. Petitioners have failed to establish Prong 2 of Althen in this case

Under Prong 2, the Petitioners need to show that it is “more probable than not” that one
or more of HH’s vaccination of August 26, 2005, did initially cause HH’s own condition. But
this they have also failed to do, for all of the reasons detailed above in Sections IX of this
Decision.

4. Petitioners have failed to establish Prong 3 of Althen in this case

Since I have explained why Petitioners have failed to satisfy the first and second prongs
of Althen, I need not discuss why Petitioners’ case also fails to satisfy the third prong. However,
as discussed above (Section IX(B)), the evidence clearly shows that HH was suffering from a
neurodevelopmental disorder prior to the vaccinations in question, so that clearly those
vaccinations did not initially cause her developmental disorder.

B. Applying the Loving/Althen standard to Petitioners’ “significant aggravation” claim

If Petitioners’ arguments in fact raise an alternative “significant aggravation” claim, that
claim, too, must be rejected.

1. Analysis of a “significant aggravation” issue is guided by the ruling in Loving.

The Vaccine Act states that “[t]the term ‘significant aggravation’ means any change for
the worse in a preexisting condition which results in markedly greater disability, pain or illness
accompanied by substantial deterioration of health.” §300aa-33(4).
The elements of an off-Table significant aggravation case were set forth in Loving v.
HHS, 86 Fed. Cl. 135, 144 (2009). The United States Court of Appeals for the Federal Circuit
acknowledged that “the Loving case provides the correct framework for evaluating off-table
significant aggravation claims,” in W.C. v. HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013). Thus,
the Federal Circuit Court of Appeals, which sets binding precedent for decisions by the Office of
Special Masters, endorsed the use of a six-part test for significant aggravation, which was first
elaborated in Loving. A petitioner must prove by preponderant evidence that a vaccination
caused significant aggravation by showing:
(1) the person’s condition prior to administration of the vaccine, (2) the person’s
current condition (or the condition following the vaccination if that is also
pertinent), (3) whether the person’s current condition constitutes a ‘significant

38
 aggravation’ of the person’s condition prior to vaccination, (4) a medical theory
causally connecting such a significant worsened condition to the vaccination, (5) a
logical sequence of cause and effect showing that the vaccination was the reason
for the significant aggravation, and (6) a showing of a proximate temporal
relationship between the vaccination and the significant aggravation.

W.C. v. HHS, 704 F.3d at 1357 (Fed. Cir. 2013).

The standard elaborated in Loving, and endorsed in W.C. v. HHS, combines
elements from previous Federal Circuit decisions. W.C. v. HHS, 704 F.3d at 1537 (“The
Loving test combines the first three Whitecotton factors, which establish significant
aggravation, with the Althen factors, which establish causation.”) Since the last three
elements of the Loving test include the entirety of the Althen test, with insignificant
wording modifications, the analysis of those three elements would be the same using
either standard.
2. Analysis of this case, under the six-part Loving/Althen test

In this Section, I will discuss whether Petitioners have satisfied the six-part Loving test to
establish the existence of vaccine-related significant aggravation of a preexisting condition.
1. What was HH’s condition prior to the administration of the vaccinations in
question?

On August 26, 2005, during HH’s well baby exam at six months of age, her pediatrician
recorded that she had no significant illnesses or ongoing diagnoses. (Ex. 2, p. 6.) However, with
the benefit of hindsight the evidence indicates that HH already had an abnormally small head
circumference, indicating that a serious brain problem existed prior to that date. (See discussion
at Section IX(B), above.)

2. What was HH’s condition soon after the vaccinations in question, and what
is her current condition?

Petitioners and Dr. Cave based their causation theories in this case on the factual
assertion that HH suffered a “severe adverse event,” including seizures and a dramatic alteration
in her development, within a day after her vaccinations of August 26, 2005. However, for the
reasons detailed above, I have rejected that factual assertion as mistaken. (See Section VII(C),
above.) Therefore, I find that HH’s condition soon after the vaccinations was, contrary to
Petitioners’ factual allegation, substantially unchanged from her pre-vaccination condition.
However, on December 21, 2005, four months after the vaccinations, HH’s pediatrician
expressed concern that she was not yet scooting or crawling, and indicated that her development
should be monitored carefully. (Ex. 2, p. 13.) Tragically, since then HH has proved to have a
very significant neurodevelopmental disorder, which has been classified as an Autism Spectrum
Disorder--that is her “current condition.”

39
 3. HH’s current condition legally constitutes a “significant aggravation” of
her prior condition.

As explained in the prior paragraph, I must reject Petitioners’ allegation that HH suffered
an aggravation of her condition soon after the vaccinations in question. However, in the
Loving/Althen formulation set forth in W.C. and quoted above, one question posed is whether the
vaccinee’s current condition constitutes a “significant aggravation” of the vaccinee’s condition
prior to vaccination. W.C., 704 F.3d at 1357. As to that question, my conclusion is that HH’s
“current condition” is “significantly worse” than her condition appeared immediately prior to the
vaccinations in question. Therefore, following the standard set forth in Loving and W.C., HH’s
“current condition” does amount to a “significant aggravation” of her neurodevelopmental
disorder (though the worsening has definitely not been shown to have been related to her
vaccinations).
4. Petitioners have failed to establish Prong 4 of Loving/Prong 1 of Althen.

As discussed above, Prongs 4, 5 and 6 of the Loving test are, in effect, the same as Prongs
1, 2, and 3 of the Althen standard. Under Prong 4 of Loving and Prong 1 of Althen, a petitioner
must provide a medical theory demonstrating that the type of vaccinee in question can cause a
significant worsening of the type of preexisting condition of the vaccinee. In this case, however,
for the reasons stated above, the Petitioners have failed to show that the vaccinations in question
can aggravate the type of neurodevelopmental disorder from which HH suffers. Further, the
Petitioners have failed to show that HH was afflicted with a preexisting mitochondrial disorder,
or that the vaccinations in question can aggravate a preexisting mitochondrial disorder, or any
type of neurological disorder.
Specifically, in this case the Petitioners’ theory seems to be that toxic substances
contained in some of HH’s vaccinations, especially aluminum adjuvants in the context of a
mitochondrial dysfunction/disorder, significantly aggravated HH’s neurodevelopmental disorder.
However, in this case I have already explained in detail the numerous deficiencies in Dr. Cave’s
theory in that regard. Petitioners, thus, have wholly failed to show that, whether in the context of
a mitochondrial dysfunction/disorder or in other circumstances, the types of vaccinations that HH
received can cause an aggravation of a neurodevelopmental disorder.
Accordingly, it is quite evident that Petitioners have wholly failed to establish Prong 4 of
Loving/Prong 1 of Althen in this case.
5. Petitioners have failed to establish Prong 5 of Loving/Prong 2 of Althen
in this case.

Under Prong 5 of Loving/Prong 2 of Althen, the Petitioners need to show that it is “more
probable than not” that HH’s vaccinations of August 26, 2005, did aggravate the specific
neurodevelopmental disorder of HH herself. But they have failed to do so. As discussed at
Section VII(C), above, Dr. Cave based her aggravation theory regarding HH on a misassumption
of fact. Further, as shown in Section IX(C), Dr. Cave’s theory about the cause of HH’s
neurodevelopmental delays was based upon the premise that HH suffered from a mitochondrial
dysfunction/disorder, but there is no good evidence that she did suffer from any mitochondrial
40
abnormality. Moreover, as discussed in Section IX(D) above, Dr. Cave’s theory as to how
components of HH’s vaccinations might have allegedly worsened the effects of a pre-existing
mitochondrial dysfunction/disorder lacks any evidentiary support.

Accordingly, Petitioners have failed to establish Prong 5 of Loving/Prong 2 of Althen in
this case.
6. Petitioners have failed to establish Prong 6 of Loving/Prong 3 of Althen
in this case.

Since I have explained why Petitioners have failed to satisfy the first and second prongs
of Althen (4th and 5th prongs of Loving), I need not discuss why Petitioners’ case also fails to
satisfy the Prong 3 of Althen/Prong 6 of Loving. However, in the interest of completeness, I will
analyze whether there was “a showing of a proximate temporal relationship” between the
vaccinations and the alleged significant aggravation of HH’s neurodevelopmental disorder.
As to an alleged significant aggravation of HH’s neurodevelopmental disorder soon after
the vaccinations, I note that the report of symptoms of HH’s developmental delay was not made
until December 21, 2005, four months after the vaccinations in question, when her pediatrician
recorded his concern that she was not scooting or crawling. (Ex. 2, p. 13.) During those four
months, there are no entries in the medical records linking HH’s vaccinations temporally to any
adverse reactions or the loss of any previously acquired skills. Thus, Petitioners have not shown
a proximate temporal relationship between the vaccination and the alleged significant
aggravation. They have failed establish Prong 6 of Loving/Prong 3 of Althen in this case.

C. This not a close case.
As noted above, in Althen, the Federal Circuit indicated that the Vaccine Act involves
“system created by Congress, in which close calls regarding causation are resolved in favor of
injured claimants.” Althen, 418 F.3d at 1280. Accordingly, I note here that this case is
ultimately not a close call. For all the reasons set forth above, I find that Dr. Cave’s causation
theory, either as to “initial causation” or “significant aggravation,” was not at all persuasive,
while Respondent’s expert was far more persuasive.40

XI
NOTATIONS CONCERNING VIABILITY OF DR. CAVE, AND
THE “MITOCHONDRIAL DISORDER” THEORY IN GENERAL

A. Dr. Cave

40
It should be noted that in this case the Petitioners never came close to carrying their burden of making a “prima
facie” case showing that HH suffered a vaccine-caused or vaccine-aggravated injury. Therefore, the burden never
shifted to Respondent to demonstrate that HH’s condition was “due to factors unrelated to the administration of the
vaccine.” §300aa-13(a)(1)(B).

41
 As I have stressed above, I found that Dr. Cave, despite her apparent sincerity, to be a
very unpersuasive witness in this case. As explained, Dr. Cave, in general, presented a muddled,
often illogical, and sometimes self-contradictory theory of causation. Dr. Cave based her theory
of vaccine-causation in this case on an assertion that a child with a mitochondrial “dysfunction”
would be more susceptible to vaccine-causation of a neurodevelopmental disorder, than a child
without mitochondrial disease, without any coherent explanation of why that might be the case.
(See Section IX(D), above.) Further, she insisted that HH suffered from a mitochondrial
“dysfunction,” even though she seemed to be poorly informed about the diagnosis of
mitochondrial disease, and grossly misapplied the accepted set of medical criteria for diagnosing
mitochondrial disorders. (See Section IX(C) above.)
Further, Dr. Cave insisted upon relying upon a factual assumption concerning HH’s
symptom history that was flatly contradicted by HH’s medical records, even after being warned
on a number of occasions by Special Master Campbell-Smith that Dr. Cave’s factual assumption
was untenable in light of the medical records. (See Section VII(C) above.)
Moreover, Dr. Cave’s totally unpersuasive presentation in this case appears to be the
norm for her. For example, as detailed above at p. 22, Dr. Cave was warned in the Berge and
Blake cases, in 2010 and 2011, that her causal opinions would be rejected when contradicted by
the medical records in the case. In addition, special masters have often commented negatively
upon the quality of Dr. Cave’s presentations as an expert witness. In Blake v. HHS, No. 03-31V,
2014 WL 2769979 (Fed. Cl. Spec. Mstr. May 21, 2014), Special Master Vowell observed that “I
do not attribute great weight to Dr. Cave’s opinion as she lacks expertise in the specialties
relevant to the issues in this case,” particularly in the fields of developmental pediatrics, pediatric
neurology and pediatric immunology. Id. at *15. In Nilson v. HHS, No. 98-797V, 2005 WL
6122524 (Fed. Cl. Spec. Mstr. Aug. 31, 2005), Special Master Sweeney (now Judge Sweeney)
compared the expert reports and testimony of both Dr. Cave and Dr. Wiznitzer regarding several
disputed issues, and found that Dr. Wiznitzer’s opinion on each was more credible. Id. at *17-
*20. The special master concluded that “[i]n this case, Dr. Cave's theories of causation were
effectively rebutted by a highly-credentialed pediatric neurologist, Dr. Wiznitzer, whose
testimony was far more credible and compelling.” Id. at *20. In Mooney v. HHS, No. 05-266V,
2014 WL 7715158 (Fed. Cl. Spec. Mstr. Dec. 29, 2014), Special Master Vowell declined to
award costs for the production of Dr. Cave’s expert opinion, awarding only a small amount for
consultation services, adding that “I am unlikely to authorize Dr. Cave’s consultant fees for
hearing preparation in any similar cases filed by Mr. Cave.” Id. at *14.
Finally, in Miller v. HHS, No. 02-235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. August
18, 2015), Special Master Vowell, like Special Master Sweeney in Nilson, specifically compared
the qualifications and testimony of Dr. Cave and Dr. Wiznitzer, and found Dr. Cave’s testimony
to be far inferior in quality and credibility. 2015 WL 5456093 at *11-12, *26-29, *34-35, *41-
43. Special Master Vowell specifically found that Dr. Cave’s attempts to use the Morava
criteria, the same criteria at issue in this case, showed a “lack of understanding” of those criteria.
Id. at *29.
Therefore, even in this case, whether it was reasonable for Mr. Cave to proceed to
hearing with Dr. Cave as his sole expert is quite questionable. But certainly, I hereby put
Vaccine Act attorneys (and pro se litigants) on notice that if Dr. Cave’s opinion, relying on the
same discredited theories and approaches, is offered in other Vaccine Act cases, I will not be
42
likely to compensate such a petitioner for any work by Dr. Cave performed after the publication
date of this Decision.
B. Experts alleging vaccine-causation of ASDs in conjunction with an alleged mitochondrial
disorder
In addition, in a number of cases recently, each involving a child with an ASD, expert
witnesses for petitioners have based their causation theories on an allegation that the child suffers
from a mitochondrial dysfunction or disorder. But in many of those cases, as in this case, there
has been a lack of any persuasive evidence that the child even has any type of mitochondrial
disorder. See, e.g., Coombs v. HHS, supra; Brook v. HHS, supra; Miller v. HHS, supra; Allen v.
HHS, supra; Krakow v. HHS, supra.
In all those cases, there also has been a lack of persuasive evidence that even genuine
mitochondrial disorders are of any relevance--i.e., as in this case, a lack of any persuasive
evidence that the existence of a true mitochondrial disorder can make a child more susceptible to
the causation or aggravation of an ASD by vaccination.
In this regard, I am aware that in Paluck v. HHS, 786 F.3d 1373 (Fed. Cir. 2015), the
Court of Appeals affirmed a ruling that a particular child’s mitochondrial disorder was
significantly aggravated by receipt of MMR, varicella, and pneumococcal vaccines, thereby
affecting the course of the child’s neurodevelopmental disorder. I have also reviewed the
medical article by Poling et al., Developmental Regression and Mitochondrial Dysfunction in a
Child with Autism, 21(2) J. Child Neurology 170 (2006). However, the facts in Paluck were
quite different from the circumstances in any of the cases cited above. Moreover, in no case
presented to me, nor in any of the cases cited above, has there been presented any persuasive
evidence that even in a child with an actual mitochondrial disorder, vaccines can cause or
aggravate that child’s ASD.
Therefore, I strongly advise counsel in Vaccine Act cases to carefully scrutinize, for
credibility, any cases in which an expert witness asserts that the existence of a mitochondrial
disorder caused the child to be susceptible to causation or aggravation of an ASD by vaccines.
If, as in this case, and in the cases cited at Section 11(A) above, there is no credible evidence that
the child even suffers from a mitochondrial disorder, I will be unlikely to find that the use of such
expert was reasonable, and thus compensable. Further, even in the context of an actual
mitochondrial disorder, the expert must be able to supply credible evidence that a mitochondrial
disorder can make a child susceptible to causation or aggravation of an ASD by vaccines, or else
I may, again, be disinclined to compensate the attorney for presenting such expert.

XII
CONCLUSION
The record of this case demonstrates plainly that HH and her family have been through a
tragic ordeal. The great dedication of HH’s family to her welfare is readily apparent to me.

43
 Nor do I doubt that HH’s parents are sincere in their belief that HH’s vaccinations played
a role in initially causing or aggravating HH’s neurodevelopmental disorder. HH’s parents have
heard the opinion of Dr. Cave, who professes to believe in a causal connection between vaccines
and neurodevelopmental disorders. After studying the extensive evidence in this case, I am
convinced that the opinion provided by Petitioners’ expert in this case, advising the Hardy family
that there is a connection between the vaccinations in question, and the causation or aggravation
of HH’s neurodevelopmental disorder, was quite wrong. Nevertheless, I can understand why
HH’s parents found such opinion to be believable under the circumstances. I conclude that the
Petitioners filed this petition in good faith.
Thus, I feel deep sympathy for the Hardy family. Further, I find it unfortunate that my
ruling in this case means the Program will not be able to provide funds to assist this family, in
caring for their child who suffers from a serious disorder. It is my view that our society does not
provide enough assistance to families of all children with ASDs or similar disorders, regardless
of the cause of their disorders. And it is certainly my hope that our society will find ways to
ensure that in the future much more generous assistance is available to all such children. Such
families must cope every day with tremendous challenges in caring for their children, and all are
deserving of sympathy and admiration. However, I must decide this case not on sentiment, but
by analyzing the evidence. Congress designed the Program to compensate only the families of
individuals whose injuries or deaths can be linked causally, either by Table Injury or
presumption or by preponderance of “causation-in-fact” evidence, to a listed vaccine. In this
case, the evidence advanced by Petitioners has fallen far short of demonstrating such a link.
Accordingly, I conclude that the Petitioners in this case are not entitled to a Program award on
HH’s behalf.41

IT IS SO ORDERED.

/s/ George L. Hastings, Jr.
George L. Hastings, Jr.
Special Master

41
In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter judgment
accordingly.

44