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

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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.”

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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

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

accordingly.

44