1 IN THE UNITED STATES COURT OF FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

No. 99

- 0855 V
( Filed: May 16 , 2013 )

TO BE PUBLISHED 1

* * * * * * * * * * * * * * * * * * * * * * * * * * * *

BRIAN FRANKLIN and ANDREA *

FRANKLIN

, as legal representatives of *

Scott P. Franklin

, a minor, *

*

Petitioner s
, * Vaccine Act Entitlement;

v. * Causation

- in

- fact;

* Vaccination/Encephalopathy

* Causation Issue;

* Vaccination/Autism

SECRETARY OF HEALTH * Causation Issue.

AND HUMAN SERVICES, *

*
Respondent. *

*

* * * * * * * * * * * * * * * * * * * * * * * * * * * *

Gregory Kincaid and Allen Coon

, Olathe

, Kansas, for Petitioners.
Vincent Matanoski, Lynn Ricciardella, and Heather Pearlman, Washington, D C, for Respondent.

DECISION

HASTINGS, Special Master

.

This is an action in which the P etitioner s
, Brian and Andrea Franklin, seek an award under the National Vaccine Injury Compensation Program (hereinafter “the Program” 2

1 Because I have designated this document to be published, this document will be made available to the public unless petitioner files, within fourteen days, an objection to the disclosure of any

material in this 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). ), on

2 The applicable statutory provisions defining the Program are found at 42 U.S.C. §300aa

- 10 et

seq . (2006). Hereinafter, for ease of citation, all “§“references will be to 42 U.S.C. (2006). I will also sometimes refer to the Act of Congress that created the Program as the “Vaccine Act.”2 account of an ongoin g severe neurode velopmental disorder in their son, Scott, that has been

characterized as an Autism Spectrum Disorder (“ASD”)

. For the reasons set forth below, I

conclude that the P etition er s are not entitled to an award on Scott’s behalf.

I

THE APPLICABLE STATUTORY SCHEME AND CASE LAW

Under the National Vaccine Injury Compensation Program, compensation awards are

m ade to individuals who have suffered injuries after receiving vaccines. In general, to gain an award, a petitioner must make a number of factu al de monstrations, including showing that an

individual received a vaccination covered by the statute; received it in the United States; suffered a serious, long

- lasting injury; and has received no previous award or settlement on account of the injury. Fin ally

-- 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 occurr ence 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 exist s 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)(A); § 300aa

- 11(c)(1)(C)(ii). ) In such a situation, of course, the presumptions available under the Vaccine Injury Table are inoperative. The burden is on the petitioner to introduce evidence demonstrating that the vaccination actually caused the injury in question. ( Althen v.

HHS , 418 F.3d 1274, 1278 (Fed. Ci r. 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 u sed in tort litigation. ( § 300aa 13(a ) ( 1)(A); see also

Althen , 418 F. 3d at 1278; Hines , 940 F.2d at 1525. ) Under that standard, the petitioner must show that it is “more probable than not” that the vaccination was the cause of 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 condition, but must demonstrate that the vaccination was at least a “substantial factor” in causing 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;” the logical sequence must be supported by “reputable medical or scientific explanation, i.e. , evidence

in the fo rm of scientific studies or expert medical testimony.” ( Althen , 418 F.3d at 1278; Grant v.

HHS

, 956 F.2d 1144, 1148 (Fed. Cir. 1992). )

The Althen court also provided additional discussion of the “causation

- in

- fact” standard,

as follows:3 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 vaccinatio n was the reason for the injury; and (3) a showing of a 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 evidence, that th e 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 the petitioner’s causation

c ontention, 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 wit h 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 h ave 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 eleme nt 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 ou t 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.

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. One of the factors listed in

Daubert is w hether the scientific theory “has been subjected to peer review and publication.” ( 509 U.S. at 593. ) The Court noted that while publication does not “necessarily” correlate with reliability, since in some instances new theories will not yet have been publi shed, nevertheless “submission to the scrutiny of the scientific community is a component of ‘good science,’” so

that the “ fact of publication (or lack thereof) in a peer reviewed journal thus will be a relevant, though no t dispositive, consideration in as sessing the scientific validity” of a theory. ( Id . at 593

- 94. )4 II

FACTS AND PROCEDURAL HISTORY

A. Facts

Petitioner s’ son, Scott Franklin , was born on July 2, 1995

, and released from the hospital on July 3, 1995

. ( Ex. 1, pp. 2

- 3 .) On July 8, 1995, Scott was returned to the hospital due to a high bilirubin level in order to under go incubator light treatment

, but was subsequently released

as a well

- baby . ( Id

. 3 ) The records of Scott’s visits to his pediatrician during his first 15 months of life appear to indicate generally normal health and development. ( Ex. 3 , pp. 9

- 17 .)

On October 7, 1996, at age 15 months, Scott received two immunizations

-- a measles,

mump s, and r ubella (“MMR”) inoculation

, and a “ Tetramune ” 4 inoculation

, at Dr. Seibel’s office. (Ex. 3.2, p. 1.) Scott returned to Dr. Seibel ten days later, on Oct ober 17, 1996. (Ex. 3.4, p. 1 .) The pediatrician’s notes concerning that visit indicate that Scott wa s “pulling at his ears,” was “fussy,” had “loose stools,” and had “low grade,” apparently meaning a slight fever. ( Id .)

The notes made by Scott’s mother concerning the same visit indicate that Scott was exhibiting symptoms in cluding, “appetite/diarrhea/tired/fever/grouchy/gassy/yellow/red spots.” (Ex. 46, p. 7.) Dr. Seibel concluded from the symptoms that Scott was “teething.” (Ex. 3.4, p. 1.)

On July 16, 1997, during a two

- year well

- child visit to Dr. Seibel, t he notatio n indicates that Scott had previously spoken, but was now not speaking. (Ex. 3.5, p. 1. ) According to the

record of that visit

, Scott was not taking any medications, had no illness, and had not had any

reactions to his immunizations. ( Id .) It was recommended that Scott’s parents contact Dr. Seibel if improvement in speech did not occur in the following two to three months. ( Id. )

Scott visited Dr. Seibel on May 2, 1998, when it was noted tha t he was only saying two words, “does not establish eye c ontact,” and “appears to ‘tune [Dr.Seibel] out.’” At that visit, Scott was diagnosed with speech delay. ( Ex. 3.5

, p. 6.)

Potential developmental delay was addressed at Scott’s three

- year well

- child examination on August 11, 1998. ( Ex. 3.5, p 7. ) Scott’s mother expressed concerns about Scott’s continued minimal speech, as well as difficulties in interacting with others and self

- stimulating behavior. ( Id

. at 8. ) Dr. Seibel made a referral for an assessment of Scott’s possible developmental delay

and autism. ( Id

. )

3 Petitioners filed Exhibits 1 through 6 .1 with the petition, and additional exhibits on several

occasions thereafter. Respondent filed exhibits labeled from A to CC at various times. “Ex.” references will be to those exhibits. “Tr.” references will be to the pages of the transcript of the evidentiary hearing held on November 30, 2011.

4 Tetramune is a combined immunization against dip htheria, tetanus, pertussis, and haemophilus influenza type B (“Hib”). Dorland’s Illustrated Medical Dictionary (31 st ed. 2007), p. 1931.5 Scott was examined by Dr. Aft ab Qadir, at the Arnold Palmer Hospital on September 9, 1998. ( Ex. 5.1, p. 6.) There, his p arents reported that Scott “just quit talking” before his sister

was born , about one year previously . ( Id. ) The remainder of the history was similar to that given

to Dr. Seibel during the visit of August 10, 1998

, although Mrs. Franklin added that her father and brother had “some of the same qualities as her son.” ( Id. ) The physician’s impression was

“ P ervasi ve developmental disorder NOS ” and “Speech and Language Disorder .” ( Id. at 7.)

Dr. John McReynolds evaluated Scott’s symptoms on October 20, 1998, and concluded that he suffered from “pervasive developmental disorder and se vere language disorder,” but

d eclined to identify a cause. (Ex. 31, p. 3.)

On November 12, 1998, Scott was seen by Dr. Michael Pollack for an initial visit at the Neurology Clinic of the N emours Children’s Clinic. ( Ex. 3.5 , pp. 55

- 56.) The diagnostic impression was “ autistic disorder. ” ( Id. at 56.) Follow

- up visits to Nemours Children’s Cli nic were made on January 6, January 22 , and March 1, 1999, in which Scott was evaluated in the

division s of Genetics and Metabolism, as well as Gastroenterology. ( Ex. 3.5 , pp. 49

- 54.) No

s pecific genetic or met abolic cause for Scott’s disorder w as identified. ( Id. )

On January 13, 1999, Scott was evaluate d by Dr. Jeff Bradstreet. ( Ex. 6 , p. 1 .)

Dr. Bradstreet’s diagnosis was “ autism. ” ( Id. at 3.) Dr. Cornelia Franz assessed Scott’s condition on February 6, 2001, and identified it as “autism.” (Ex. 28, p. 3.)

T he medical records, in general, further indicate that Scot t has continued to suffer

, since that time, from a severe developmental disord er, which has consistently been labeled as “autism ” or as a disorder falling within the autism spectrum. 5

B. Procedural History

The Petitioners

, Andrea and Brian Franklin

, file d their Program p etition on October 1, 1999, alleging that Scott’s severe developmental disorder was caused by his MMR vaccination

of October 7, 1996. Proceedings were delayed for several years at P etitioners’ request , to give

them time to assemble and file medical record s and expert reports . During 1999 to 2002,

P eti tioners filed several expert report s of Dr. Jeff Bradstreet and D r. John Menkes. (Exs. 6.1, 22, 23, 26.) Respondent filed “R ule 4 reports” indicating the view that compensation of the case was

not appropriate. (ECF No. 47 ; ECF No. 50.) Respondent also filed several expert reports, opposing Petitioners’ claim. (Exs. A, C, E, G, K.)

5 “Autism spectrum disorder” is a general classification which includes 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 five types of disorders falling within the autism spectrum. ( Id .) Scott’s own disorder has been characterized as “autis tic disorder” (Ex. 3.5 at pp.

55

- 56); as PDD

- NOS (Ex. 5.1, p. 3); or simply as “autism” (Ex. 6, p. 3), all of which labels indicate that Scott’s disorder falls within the general category known as “autism” or “autism spectrum disorder.”6 From 2003 until January 15, 2008, there was no activity in the case, again at the Petitioners’ request, as the Peti tioners chose to await the outcome of the Omn ibus Autism Proceeding (“OAP”) t est c ases. The Omnibus Autism Proceeding was a general proceeding under the Program in which attorneys representing about 5,000 different Program p etitioners worked together in a n attempt to demonstrate that certain types of vaccines, including the MMR vaccine, can cause the neurodevelopmental disorder known as “autism.” 6

On January 15, 2008, P etitioner s were o rdered to file all medical records relating to Scott’s illness, as well as a statement addressing whether they wanted to continue

, or await the

outcome of the OAP. (ECF No. 69.) On February 19, 2008, Petitione rs filed a “ Statement of Compliance ,” indicating that they had filed all releva nt medical records. (ECF No. 70.)

On June 4 , 2008, P etitioners filed an Amendment to their p etition

, raising an “alternative” allegation th at if Scott’s developmental disorder was not initially caused by his MMR

vaccination , it was significantly aggravated by that vaccination

. (ECF No. 75.)

On February 12, 2009, three special masters separately issued decisions in the first three

“ test cases ” in the OAP : Cedillo v. HHS , No. 98

- 916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009) ; Snyder v. HHS , No. 01

- 162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009) ; and Hazlehurst v. HHS , No. 03

- 654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009). All three decisions determined tha t the evidence failed to demonstrate any general causal

con nection between the MMR vaccine and the d evelopment of autism spectrum disorders. These

decisions were each subsequently affirmed

, on appeal , by three different judges of th e U.S. Court

of Federal Claims

. Hazlehurst v. HHS , 88 Fed. Cl. 473 (2009); Snyder v. HHS , 88 Fed. Cl. 706 (2009); Cedillo v. HHS , 89 Fed. Cl. 158 (2009). Subsequently

, the two cases that were appealed to the U.S. Court of Appeals for the Federal Circuit, Cedillo and Hazlehurst , were again

affirmed. Cedillo v. HHS , 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. HHS , 6 04 F.3d 1343 (Fed. Cir. 2010). ( The Snyder case was not appealed to the Federal Circuit.)

In March 2010, the same three special masters issued three more opinions in three more

OAP “ test cases, ” this time rejecting the second causation theory presented in the OAP

, that

thimerosal

- containing vaccines can cause autism

. 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); Dwyer v. HHS , No. 03

- 1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010). None of tho se decisions were appealed.

The Petitioners in this case, after the first three OAP test case decisions were issued,

informed the court that th ey now wished to proceed with their claim

, and would be filing a new expert opinion in support. On April 26, 2010

, P etitioners filed an expert medical report from

Dr. J. Ivan Lopez. (Pet. Ex. 38.) Shortly thereafter, P etitioners filed a supplemental expe rt report from Dr. Lopez, as well as an affidavit from Cornelia Franz, M.D. ( Pet. Exs. 39, 42 .) Respondent filed responsive expert reports from Dr. Neal Halsey and Dr. Max Wiznitzer. (Resp

.

6 For further discu ssion of the OAP, see Cedillo v. HHS

, No. 98

- 916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), at *8

- 11.7 Exs. P, Q.) Petitioners filed a nother supplemental expert report from Dr. Lopez on February 17, 2011. (Pet. Ex. 43.)

After P etitioners and R espondent filed t heir expert reports in 2010 and 2011 , I conducted an evidentiary hearing on November 30, 2011. At that hearing, P etitioners relied solely on the testimony of Dr. Lopez , while R espondent presented oral testimony from Dr s

. Wiznitzer and Halsey. At the hearing, I requested that the parties file post

- hearing briefs. Petitioners’ post

hearing brief was filed on April 30, 2012, and R espondent’s post

- hearing brief was filed on July 3, 2012. On August 16, 2012, P etitioners’ counsel informed the court that he did not intend to file a post

- hearing reply brief. Thus, the case is now ripe for a ruling concerning the issue of “entitlement, ” i.e. , whether P etitioners have demonstrated that they are entitled to a Program

award on Scott’s behalf.

II I

ISSUE TO BE DECIDED

In this case, P etitioners seek a Program award, contending that the developmental

disorder from which Scott suffers was “caused

- in

- fact” by an “encephalopathy” resulting from

one of the vaccination s that he received on October 7, 1996

. After careful consideration, I

conclude that P etitioner s have fail ed to demonstrate causation. 7

Petitioner s ’ theory of the case

, as pre sented at the evidentiary hearing and in their post

hearing brief, may be briefly summarized as follows. Petitioners contend that Scott’s condition of severe developmental delay, described above at pp. 4

- 5

, should not be considered an autism

spectrum disorder (“ASD”). Peti tioners contend that Scott’s condition, instead, was caused by

an “ encephalopathy ” (brain injury) resulting from one of the vaccination s that he received on October 7, 1996

. ( See “ Petitioners’ Post Trial Memorandum” filed on April 30 , 2012, at pp. 17

- 21.)

Respondent disagrees, contending that P etitioners have failed to meet the burden of proving causation. Respondent argues that Scott’s clinical history, in the days after the

vaccination s in question, is inconsistent with the “encephalopathy” that Petitioners allege

. Respondent’s experts believ e that Scott has a typical case of ASD, which has nothing to do with any vaccinations

.

7 Petitioners have the burden of demonstrating the facts necessary for entitlement to an award by a “preponderance of the evidence.” 300aa

- 13( a ) (1)(A). Under that standard, the existence of a fact must be shown to be “more probable than its nonexistence.” In re Winship , 397 U.S. 358, 371 (1970) (Harlan, J., concurring).8 After carefully considering all of the evidence in the record, I must reject P etitioners’

claim 8 that Scott’s severe neurodevelopmental condition , which has been characterized as an

ASD , w as caused by one of his v accination s

.

I V

SUMMARY OF EXPERT WITNESSES’ QUALIFICATIONS AND OPINIONS

In this case, each side relies upon the expert r eports and hearing testimony of medical

experts. At this point, I will briefly summarize both the qualifications and the opinions of those expert witnesses.

A. Petitioner s ’ experts

1. Dr. J. Ivan Lopez

Dr. J. Ivan Lopez attended La Salle University School of Medicine from 1977 to 1982

. (Ex. 44. at 9 .) He completed his residency in orthopedic surgery in Mexico City between 1984

and 1988

. ( Id. at 3. ) He completed his pediatric residency at the University of South Alabama Department of Pediatrics from 1992 to 1993

, followed by his neurology residency , at the University of South Alabama, from 1993 to 1997. ( Id. at 2. ) From 1997 to 2003

, Dr. Lopez worked in private practice in both Florida and Georgia. ( Id. ) He became an Assistant Clinic al Professor of Pediatrics at Mercer University School of Medicine in 2002

, and then an Associate Professor of Neurology at the University of South Alabama in 2003

, where he continued to work in various capacities until 2009. During the time of his testim ony in this case , Dr. Lopez was an Associate Professor of Neurology and Pediatrics at the University of Alabama in Birmingham. ( Id. ; Tr. 69.) He is board

- certified by the American Board of Psychiatry and Neurology, with a special qualification in Child Neurology. (Ex. 44, p. 13.)

Dr. Lopez filed a n expert report in this case on April 26, 2010, Exhibit 38; a supplemental report

, on October 1 2, 2010, Exhibit 42 ; and an additional supplemental report on February 17, 2011, Exhibit 43 . Dr. Lopez also testified at the evidentiary hearing in Orland o, Florida

, on November 30, 2011.

2. Dr. Cornelia Franz

Dr. Franz is a board

- certified p ediatrician

, in practice for 25 y ears in Orlando, Florida. ( Ex. 39 at 1.) She attended Wake Forest University as an undergraduate

, and subsequently received her medical degree from Bowman Gray School of Medicine in Winston

- Salem, North Carolina. ( Id. ) She completed her pediatric internship in Lexington, Kentucky. ( Id. ) Following her internship , she did a fellowship in Adolescent Medicine at Cincinnati Children’s Hospital. ( Id. ) Dr. Franz was the founder of The Franz Center in Orlando, Florida, wherein she conduct s a

8 Petitioners’ claim in this case is solely a “causation

- in

- fact” claim. T hey do not argue that Scott suffered a “Table Injury” encephalopathy, as that injury is defined in the applicable regulations. (See, e.g. , “Petitioners’ Post Trial Memorandum,” filed on April 30, 2012.)9 practice which specializes in general pediatrics. ( Id. ) She routinely provides vaccines to patients

as part of pediatric care , and has privileges at the Arnold Palmer Hospital for Children and Women in Orlando. ( Id. )

3. Summary of o pinion s of Petitioners’ e xperts

Petitioners ultimately relied most heavily on the opinion of Dr. Lopez, who was the only expert that they presented at the evidentiary hearing. In his three written expert reports (Exs. 38, 42, 43), and in his hearing testimony (Tr. 68

- 133, 273

- 281 ), Dr. Lopez opined that one of the vaccinations that Scott received on October 7, 1996, caused him to suffer an “encephalopathy”

-- i.e

., a brain injury

-- which encephalopathy caused Scott’s subsequent developmental disorder.

In his third w ritten report, Dr. Lopez proposed a mechanism by which the vaccination caused the brain injury, a process known as “molecular mimicry.” (Ex. 43, p. 1.) In this process, he explained, some portion of the vaccine “closely resembles the molecular structure of the myelin sheath of the neurons

, thereby confusing the immune system of the individual.” ( Id .) In other words, because of this resemblance, the body’s immune system mistakenly attacks the neurons, which are a component of the brain, in what is known as an “autoimmune” process.

Dr. Lopez also described this process as a “post

- vaccination encephalomyelitis,” meaning a swelling of the myelin sheath of the brain, due to the misguided attack by the immune system. (Ex. 38, p. 2.)

In further explanation , Dr. Lopez opined that Scott’s developmental disorder, while it

does include symptoms similar to those of autism, should not be characterized as “autism.”

Dr. Lopez opined that if a cause is known for a disorder such as Scott’s , that disorder is thereby disqualified from the category of autis m. (Ex. 42, p. 1; Ex. 43, p. 1.)

Petitioners also rely, secondarily, on the opinion of Dr. Franz, who has been Scott’s treating pediatrician. 9

9 As noted above, soon after they filed their petiti on, Petitioners filed written reports of two other experts, Dr. James Jeffrey Bradstreet and Dr. John Menkes. (Exs. 6.1, 21, 22, 23, 26.) However, as also noted, they then chose not to pursue their case to a ruling at that time, but chose instead to

wait for the outcome of the Omnibus Autism Proceeding. After the publication of the autism “test case” opinions described above (see p. 6), petitioners elected not to rely upon the opinions

of Dr. Bradstreet and Dr. Menkes , but to instead rely solely upon the opinions of Drs. Lopez and Franz. (See, e.g ., Tr. 153.) Accordingly, I have not analyzed the opinions of Dr. Bradstreet and

Dr. Menkes in this Decision. However, I note that I have read the reports of Drs. Bradstree t and Menkes, and have found them to be unpersuasive. Moreover, I found those opinions to be persuasively refuted by the experts reports of Drs. Wiznitzer and Halsey filed by Respondent, particularly Exs. C and E. Dr. Franz did not testify at the evidentiary hearing

, but supplied an

a ffidavit, which stated that “[b] ased on my 25 years of experience as a pediatrician, and after reviewing the photographs and DVD footage supplied to me, it is my opin ion that Scott Patrick

Franklin* * * was developing normally and meeting appropriate mile st ones for his age at 11

months. He thereafter suffered some form of neurologic injury, which resulted in loss of language and regression in behavior and most likely permanent injury to his brain. ” ( Ex. 39

,10 p. 2. ) Dr. Franz added that Scott’s neurode velopmental disorder “ would be consistent with an encephalopathic reaction to vaccination ,” and that “ more likely than not his neurological damage was caused by encephalopathy after vaccination .” ( Id .)

B. Respondent’s e xperts

Respondent has relied primarily on the expert reports and testimony of two experts, Drs. Wiznitzer and Halsey. 10

1. Dr. Max Wiz nitzer

Dr. Max Wiznitzer is a pediatric neurologist with an active clinical and research practice

, who has diagnosed and treated thousand s of children with ASDs. (Tr. 208

- 10, 213; see also Ex BB.) Dr. Wiznitzer received a B.S. in Medical Education in 1975 from Northwestern University. (Ex. D at 1.) He received his M.D. from Northwestern University in 1977. ( Id. ) Dr. Wiznitzer completed his residency in pediatrics at the Children’s Hospital Medical Center of Cincinnati from 1977 through 1980, and thereafter completed his fellowship in developmental disorders at the Cincinnati Center for Developmental D isorders in 1981. ( Id. )

Dr. Wiznitzer is board

- certified in pediatrics

, pediatric neurology, and

neurodevel opmental disabilities. (Tr. 204.) He is an Associate Professor of Pediatrics, Neurology and International Health at Case Western Reserve Universi ty School of Medicine, and a staff child neurologist at the Rainbow Babies a nd Children’s Hospi tal in Cleveland, Ohio. (Tr. 202

- 03.) Dr. Wiznitzer is a member of the American Academy of Neurology

, the American Academy of Pediatrics (“AAP”), and the Child Neurology Society. (Tr. 204, 206.) He sits on the

AAP’s Executive Committee for the Council on Children with Disabilities

, and is the neurology representative to the Autism Su bcommittee of the AAP. (Tr. 210

- 11.) He has also extensively researched and pu blished articles and papers on autism. (Tr. 212

- 13; see also Ex. BB.)

2. Dr. Neal Halsey

Dr. Halsey received a B.S. in Zoology fr om the University of Wisconsin in 1967. He

then received his M.D. fr om the University of Wisconsin in 1971. (Ex. F at 1.) In 1972

, Dr. Halsey complete d an internship at the Children’s Hospital, Denver, Colorado. ( Id. ) He was then a

General Medical Officer of the Indian Health Service at the U.S. Public Health Service Hospit al

in Fort Yates, North Dakota

, from 1973 to 1974. ( Id

. ; Tr. 158.) Dr. Halsey completed his residency at the University of Colorado Medi cal Center from 1974 to 1975. (Ex. F at 2.)

10 Respondent also filed expert reports o f Drs. John MacDonald and John Sever. However, those reports primarily were devoted to refuting the petitioners’ early expert reports of Drs. Bradstreet and Menkes. Accordingly, while I have read the reports of Drs. MacDonald and Sever, they have not pla yed any role in my resolution of this case.11 Additionally, Dr. Halsey has served as a professor at Tulane University from 1980 through 1985

, in both the Department of Pe diatrics and the Department of Tropical Medicine

. ( Id. at 2.) Dr. Halsey also has served at The Johns Hopkins University, School of Hygiene and

Public Health

, from 1985 to present , and works primarily in the International Health Department

, with a primary office in the Institute for Vaccine Safety

. (Ex. F at 2 ; Tr. 159

- 60.) Dr. Halsey has

also served in many medical organizations and written many publications regarding

immunization. ( See generally Ex. F; Tr. 162.)

Dr. Halsey is board

- certified in pediatrics and in pediatric infectious diseases. (Tr. 158.) During Dr. Halsey’s time at the Indian Health Service, he dealt with a measles epidemic and conducted an investigation about the measles vaccine and its ability to protect aga inst disease

. (Tr. 159.)

Additionally, Dr. Halsey has written over 200 peer

- reviewed publications on vaccine

preventable diseases and immunizations, has authored or co

- authored over 40 book chapters pertaining to immunizations, and has been a reviewer or editor for dozens of journals. (Tr. 1 62

- 63.) Dr. Halsey has served on advisory committees for the American Academy of Pediatrics, particularly the Committee for Infectious Diseases, w hich he chaired for four years. (Tr. at 162.)

He has also served ten years in the Centers for Disease Control and Prevention’s Advisory

Committee for I mmunization Pract ices. (Tr. 162.) Further more , Dr. Halsey served seven years on the World Health Organization’s Research and Development Committee for the expanded

pr ogram on immunization. (Tr. 161

- 62.)

3. Summary of o pinion s of Respondent’s e xperts

Respondent’s expert s strongly disagree with Dr. Lopez’ assertion that any of Scott’s

vaccination s caused, or have had any effect on

, his ongoing developmental disorder. In response to Dr. Lopez’ argument that Scott does not have autism, Dr. Wiznitzer testified that Dr

. Lopez “is totally wrong” in his definition and un derstanding of autism. (Tr. 226

- 27.) Dr. Wiznitzer

testified that , contrary to Dr. Lopez’ testimony, autism is not a “murky” or a “vague ” term. (Tr. 226.) Rather, “[a]utism is a well

- defined ent ity. We know what it is.” (Tr. 226.) Dr. Wiznitzer agrees with Scott’s treating physicians, who opined that Scott has an ASD, and explained that Dr. Lopez is simply wrong in his contention that for an individual to be considered autistic, the

cause of the disord er must be unknown. (Tr. 227, 243.)

Further, both Dr. Wiznitzer and Dr. Halsey strongly disagreed with Dr. Lopez’ opinion

that Scott suffered an encephalopathy in the ten days after his vaccinations of October 7, 1996. Both discussed Scott’s symptoms that were reported during Scott’s return visit on October 17, 1996, and opined that such symptoms did not indicate that S cott was suffering from an encephal opathic process at that time. (Ex. P, p. 1; Ex. Q, p. 3; Tr. 167

- 71, 240

- 42, 283

- 85.)12 V

RESPONDENT’S EXPERTS WERE FAR MORE PERSUASIVE IN GENERAL

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” that

Scott’s vac cinations of October 7, 1996, played any role in causing or aggravating his severe neurodevelopmental disorder. And the first of the reasons for this conclusion is simply th at I found Respondent’s primary experts, Drs. Wiznitzer and Halsey, to be far more persuasive than the experts upon whom Petitioners relied, Drs. Lopez and Franz.

A. Qualifications

In this regard, I start with the qualifications of the opposing experts relative to the issues raised by Petitioners’ claim. In short, the credentials o f Respondent’s experts are vastly superior. Scott is a child who has been given a diagnosis within the autism spectrum by several of his treating physicians, and as a part of his opinion in this case Dr. Lopez argues that such autism diagnosis is not a pr op er diagnosis for Scott. However, Dr. Wizn itzer disputes that part of

Dr. Lopez’s opinion, and, with rega rds to the topic of autism, Dr. Wiznitzer is far more qualified

than Dr. Lopez.

Dr. Wiznitzer regularly diagnoses and treats autism as a major part of his everyday clinical practice. (Tr. 209, 218.) He has participated with national committees in design ing protocols for the screening and diagnosis of autism. (Tr. 211.) He has participated in d eveloping protocols for treating autism as well. (Tr. 212.) He has participated in major research projects concerning autism. (Tr. 212

- 13.) And he has published articles about autism. (Tr. 213.)

In contrast to Dr. Wiznitzer , Dr. Lopez acknowledged that in his clinical practice, he does

not treat autism, nor diagnose autism. (Tr. 134, 145.) He has never been involved in studies of autism. (Tr. 143.) He has published no articles about autism. (Tr. 144.)

In a similar fas hion, Dr. Halsey is far more qualified than Dr. Lopez in terms of knowledge of the causation of disease by the measles vaccine and other vaccines. Dr. Halsey is

board

- certified in the area of pediatric infectious disease. (Tr. 158.) In a long and distin guished career, he has served in many medical organizations concerning vaccinations. (See g enerally Ex. F; Tr. 162.) He has served as the director of the Institute of Vaccine Safety at the Johns Hopkins Hospital. (Tr. 160.) He served for ten yea rs on t he Committee on Infectious Disease of the American Academy of Pediatrics, including four years as its chair. (Tr. 162.) He served for seven years on the immunization committee of the World Health Organization. (Tr. 161

- 62.) He

has written more than 200 peer

- reviewed publications concerning immunizations and vaccine

pre ventable diseases, has authored or co

- authored over 40 book chapters pertaining to immunizations, and has been a reviewer or editor for dozens of medical journals. (Tr. 162

- 63.)

In cont rast to Dr. Halsey, Dr. Lopez claimed no special experience concerning vaccines,

vaccine

- preventable diseases, or vaccine

- safety issues. He acknowledged that he has never13 studied the measles vaccine, and has published no written material concerning vaccin es. (Tr.

143

- 144.)

B. General deficiencies in Dr. Lopez’ testimony

But even more importantly than the vast gap in qualifications , between Dr. Lopez and Respondent’s primary experts, was the even greater gap in the experts’ ability to explain their opi nions. The written reports and hearing testimony of both Drs. Wiznitzer and Halsey seemed to me to be coherent and logical. In contrast, the written reports of Dr. Lopez were short and not well explained, while his hearing testimony was often poorly expl ained, self

- contradictory, and less than logical.

In fact, throughout his participation in the case, I often had difficulty understanding exactly what the opinion of Dr. Lopez was, much less his reasoning for that opinion . For example, Dr. Lopez began his first expert report by quoting a one

- paragraph description of a

well

- known condition that was often seen after infection with the wild measles virus , commonly known as “measles encephalitis” or “measles encephalopathy.” ( See Ex. 38, p. 1, first paragraph. 11 ) That caused me, Respondent’s experts, and apparently even Petitioners’ own attorney (see, e.g., Tr. 81

- 82, 93) to believe that Dr. Lopez was identifying Scott’s MMR vaccination, particularly the measles vaccine, as the culprit in Scott’s disorder, and was opining

that Scott had suffered from a form of “measles encephalopathy” or “measles encephalitis .” 12
Then, during his hearing testimony on direct exam, Dr. Lopez again referred to the same description of “measle s en cephalopathy ” with which he had begun his first expert report (T r. 81,

line 19

, to Tr. 82, line 2), and testified explicitly that such description did fit the description of Scott’s case set forth in Scott’s medical records. (Tr. 82, lines 7

- 11.) Again, this testimony of

Dr. Lopez made it appear that he was opining that Scott suffered from the well

- recognized condition of “measles encephalopathy” or “measles encephalitis.”

However, Dr. Halsey, the re nowned measles expert, then testified that while “mea sles encephalitis” was well

- recognized as occurring after infection by the measles virus , and occasionally after exposure to the measles vaccine

, in contrast

, Scott’s symptoms

, as described in his visit 10 days after his vaccinations in question

, were nothing like the well

- recognized

“ measles encephalitis ” condition . (Tr. 167

- 71 .)

In response, Dr. Lopez changed or clarified his testimony in a fairly drastic way. Suddenly, he now “agreed with Dr. Halsey that Scott didn’t have measles encephalitis.” (Tr. 274.) Dr. Lopez added that he “didn’t recall ” saying that Scott had “measles encephalitis” ( i d . at

11 That paragraph turns out to have been mostly a direct quote from an article by Dr. Menkes, which appears at Ex. 22a, p. 681, in this case. However, in his Ex. 38 Dr. Lopez neither used quotation marks nor indi cated where the material was from.

12 In both his Ex. 38 (p. 1) and during his hearing testimony, Dr. Lopez quoted from the Menkes textbook excerpt, in which this well recognized post

- measles condition is described as “encephalopathy” (see Tr. 81, line 19) . However, as Dr. Halsey testified, this condition is more often called “measles encephalitis.” (Tr. 169

- 72, 177.)14 line 19), and seemed to suggest that if he had so stated, his statement had been a “mistake” ( id . at line 20). Dr. Lopez then appeared to opine that S cott had suffered a different type of encephalopathic reaction to a vaccination, with much less drastic symptoms than those of classic “measles encephalitis.” (Tr. 2 7 4

- 79.)

Dr. Lopez also “clarified” at the hearing, under cross

- examination, another crucial point that was far from clear in his written reports. He explained that it was not necessarily the

measles vaccine that caused Scott’s condition , but could have been any o f the seven separate

vaccines that Scott received on October 7, 1996. (Tr. 104.) (As noted above, Scott received the measles, mumps, and rubella vaccinations, as part of the MMR inoculation

, and also the diphtheria, tetanus, pertussis

, and haemophilus in fluenza type B vaccinations, as the four

component s of the Tet ramune immunization

. ) This testimony again undermined Dr. Lopez ’ reliability as an expert, because he had begun his first expert report with a quotation that seemed

to attribute Scott’s conditi on to a measles vaccination, and then specifically indicated in his direct examination that Scott suffered from “measles encephalopathy.” (Tr. 93, lines 18

- 21.) In other words, Dr. Lopez’ apparent ambivalence as to whether he was pointing specifically to the

measles vaccine, or generally to any of the seven vaccines, cast doubt on his reliability.

There were other glaring flaws and self

- contradictions in Dr. Lopez’ reports and heari ng testimony that diminished his persuasiveness as an expert. For example, in his first expert report,

Dr. Lopez stated that there was evidence that Scott was suffering from a condition known as

suba cute sclerosing panencephalitis (“SSPE”)

. (Ex. 38, p. 2 .) But then

, in his second repo rt,

Dr. Lopez discarded that allegation, admitting that Scott did n ot suffer from SSPE . (Ex. 42,

p. 1.)

Similarly, Dr. Lopez opined in his second written report that Scott was suffering from an “ongoing and persistent autoi mmune process.” (Ex. 42, p. 1 , part (c ).) Yet, in his hearing testimony, he changed his opinion on that point as well, stating that Scott was not suffering from

an ongoing auto immune process. (Tr. 101.)

There were other major discrepancies in Dr. Lopez’ logic that made him seem, i n the final analysis, to be very unpersuasive. Two of those flaws will be described at length in the next two sections of this Decision. First, Dr. Lopez insisted that Scott’s condition should not be labeled “autism,” for a very strange reason, despite t he fact that Scott’s treating physicians have consistently diagnosed him with autism. (See part VI of this Decision below

. ) Second,

Dr. Lopez’ entire opinion is dependent on a description of symptoms that Scott displayed about 10 days after his vaccinati ons in question, when in fact such symptoms

, as actually described in

the medical records

, seem to be very minor ones. (See part VII of this Decision below.) Again,

Dr. Lopez’ analysis of these symptoms seemed illogical on its face, even before being thoroughly refuted by respondent’s more qualified experts.

In contrast to the vagueness, ambivalence, self

- contradiction, and illogic of Dr. Lopez’ testimony, the testimony o f Drs. Wiznitzer and Halsey was coherent, consistent, and logical throughout.15 To be sure, I do not conclude that Dr. Lopez was intentionally being less than candid and honest. Nor do I have any reason to doubt that Dr. Lopez is a competent clinical practitioner in

his field. My conclusion is simply that, in general, the presentations of Drs. Wiznitzer and Halsey in this case were far more pe rsuasive than that of Dr. Lopez. 13

VI

DR. LOPEZ WAS UNPERSUASIVE IN ARGUING THAT AUTISM IS

NOT AN ACCURATE DIAGNOSIS FOR SCOTT

As noted above, a key part of Dr. Lopez’ opinion in this case is that he believes that Scott’s neurodevelopmental disorder s hould not be considered to be within the autism spectrum.

Dr. Lopez has opined that if one can identify a cause for a neurodevelopmental disorder, which he believes that he has for Scott’s disorder ( i.e. , a vaccination cause), then such disorder should

no t be considered to be autism . ( E.g. , Ex. 42

, p. 1; Ex. 43, p. 1 .)

However, based upon the record of this case, I conclude that Dr. Lopez is simply wrong on this point.

Fir st, as explained above (pp. 10

- 12 ), Dr. Wiznitzer is far better qualified than Dr. Lopez to opine concerning the topic of autism. And Dr. Wiznitzer testified persuasively that Dr. Lopez is “totally wrong” in his understanding of autism. (Tr. 226.) Dr. Wiznitzer testified that

Dr. Lopez was incorrect to state that if a specific cause can be identified, then the disorder is thereby not autism. (Tr. 227.) Dr. Wiznitzer listed several types of autism for which specific

causes are known. ( Id .) Dr

. Wiznitzer testified that autism is clearly the correct di ag nosis for Scott. (Ex. P, p. 1; Tr. 243 .)

Further, Scott’s medical records show that his own treating physicians have consistently identified Scott as having a disorder within the autism spectrum. For example, on November 12, 1998, Scott was g iven t he diagnosis of “autistic disorder ” by Dr. Michael Pollack . (Ex. 3.5, p. 56.) On September 9, 1998, Dr. Aftab Qadir noted that Scott has “pervasive developmental

13 I have found two instances in which other special masters of this court have commented on the opinions offered by Dr. Lopez in Vaccine A ct cases. In Banks v. HHS , 2007 WL 2296047, at *13 (Fed. Cl. Spec. Mstr. July 20, 2007), Special Master Abell relied upon the opinion of

Dr. Lopez, finding him to be “personally and professionally credible.”

On the other hand, a vaccine

- causation opinion by Dr. Lopez was recently rejected emphatically by Special Master Vowell in Henderson v. HHS , No. 09

- 616V, 2012 WL 5194060 (Fed. Cl. Spec. Mstr. Sept. 28, 2012). In that case, as in this one, Dr. Lopez opined that a neurodevelopmental disorder, which had been described as “autism,” should not be considered to

be autism because Dr. Lopez considered it to have been vaccine

- caused. Special Master Vowell rejected that opinion as incorrect, just as I do in this case. (2012 WL 594060 at *13, and fn. 49.)

Ref erring to Dr. Lopez’ causation opinion in the Henderson case in general, Special Master Vowell stated that a “better example of both circular and post hoc

, ergo propter hoc reasoning would be difficult to find.” ( Id . at *3.)16 disorder NOS,” another diagnosis with in the autism spectrum. 14 (Ex. 5.1, p. 3

-- see also fn. 5 above.) On January 13, 1999, Dr. Jeff Bradstreet stated that Scott’s disorder was “autism.” (Ex. 6, p. 3 .) Dr. Cornelia Franz also diagnosed Scott’s condition as “autism.” (Ex. 28, pp. 1

- 3.)

In short, the record of this case indicates that Dr. Lopez is quite wrong in this part of his opinion. Contrary to the opinion of Dr. Lopez, Scott clearly does suffer, tragically, from a disorder within the autism spectrum.

VII

THE EVIDENCE DOES NOT SUPPORT A CONCLUSION THAT

SCOTT’S SYMPTOMS OF OCTOBER 17 , 1996, WERE

INDICATIVE OF AN ENCEPHALOPATHY

As explained above, the second major component of Dr. Lopez’ opinion in this case is his interpretation of the symptoms that Scott experienced about 10 days after his vaccination s on October 7, 1996. As noted, Scott returned to Dr. Seibel ten days later, on October 17, 1996, and the physician’s notes concerning the visi t indicate that Sc ott was “pulling at his ears,” was “fussy,” had “loose stools,” and had “low grade,” apparently me aning a slight fever. (Ex. 3.4,

p. 1.) The notes made by Scott’s mother concerning the same visit indicate that Scott was exhibiting symptoms including, “appetite/diarrhea/tired/fever/grouchy/gassy/yellow

- red spots.” (Ex. 46, p. 7.) Dr. Lopez has interpreted those symptoms to indicate that Scott was suffering at

that time from an “ encephalopathy ”

-- i.e. , a bra in injury

-- caused by a misguided reaction of his

immune system to one of the seven vaccines that Scott received on October 7 . ( Exs. 38, 42, 43;

Tr. 72

- 73 .) However, consideration of the entire record makes me conclude that Dr. Lopez is quite mistaken in his interpretation of those symptoms. There are two major reasons for this

conclusion.

First, Scott’s treating pediatrician at the time , Dr. S iebel

, noted those symptoms

, but was apparently not alarmed at all by them. The pediatrician clearly did not conclude from tho se symptoms that Scott was undergoing an encephalopathy, since he did not send Scott to a hospital or to a specialist. Based on those symptoms, the treating pedi atrician concluded instead that

Sco tt was “teething.” (Ex. 3.4, p. 1.) It is quite dubious that Dr. Lopez’ re

- interpretation, years later

, of the written notations concerning Scott’s symptoms

, would be more reliable than the

assessment of the pediatrician who actually examined Scott at the time.

Further, Dr. Seibel specifically noted on July 16, 1997, 10 months after the s hots in question, that Scott had not suffered any “ immunization reaction

. ” (Ex. 3

. 5 at 1.)

14 In their post

- hearing brief, petitioners point out that one of Scott’s physicians, Dr. Qadir, diagnosed him not with “autism” but with “Pervasive Developmental Disorder

-- NOS”). (Brief at p. 7, para. 33; Ex. 5.1, p. 3.) However, “Pervasive Developmental Disorder Not Otherwise Specified,” also known as “PDD

- NOS,” in fact, is one of the disorders included within the autism spectrum. See, e.g. , Tr. 262

- 63; King v. HHS , No. 03

- 584V, 2010 WL 892296 at *5 (Fed. Cl. Spec. Mstr. Feb. 12, 2010).17 Second, R espondent’s experts were quite persuasive in their opinions that Dr. Lopez’ interpretation of Scott’s symptoms was grossly mistaken. Dr. Halsey testified strongly in this regard. (Tr. 167

- 76.) Dr. Halsey noted that the pediatrician’s notation that Sco tt “drinks well,”

in the notes of the October 17 visit (Ex. 3.4, p. 1), contradicts Dr. Lopez’ conclusion that Scott

wa s suffering from an encephalopathy at that time. (Tr. 168.) Dr. Halsey summarized that

Dr. Lopez’ interpretation of Scott’s symptoms “j ust doesn’t make sense; it doesn’t meet anybody’s case definition for encephalopathy.” (Tr. 167.) Dr. Halsey explained that an infant’s symptoms would have to be much more severe to justify a conclusion that the child was undergoing an encephalopathy. ( Tr. 168, 170, 171 , 200

- 201 .)

Dr. Wiznitzer also testified that the symptoms in Scott’s records do not justify Dr. Lopez’

inference o f an encephalopathy. (Tr. 240

- 42.) Dr. Wiznitzer, like Dr. Halsey, pointed to the notation that Scott was drinking well at the time , as indicative that Scott was not encephalopathic . (Tr. 241.) Dr. Wiznitzer explained that the pediatric records did not indicate any impairment of Scott’s consciousness or significant change in his mental status. (Tr. 240

- 41.) He opined th at if Scott were actually undergoing an encephalopathy, the pediatrician would have recognized it. (Tr. 241.) And he also noted that if Scott had suffered a post

- vaccination encephalopathy , that would have appeared on Scott’s MRI as damage to the gray ma tter of his brain, which it did not. (Tr. 231

- 32.)

In this regard, I also note that Dr. Lopez’ testimony on this point changed significantly during the evidentiary hea ring. As explained above (p. 13 ), after the measles expert , Dr. Halsey,

testified tha t Scott’s symptoms on October 17 could not possibly justify a diagnosis o f the well

recognized condition of “measles encephalitis, ” Dr. Lopez then seemed to opine that Scott had a different type of reaction to a vaccination, with much less drastic symptoms than those of classic “measles encephalitis.” (Tr. 274

- 79.) However, Dr. Halsey then testified in rebuttal that he also disagreed with Dr. Lopez’ new theory that Scott experienced not cl assic “measles encephalitis

, ” but some type of lesser encephalopathic reaction that could have been caused by any of the seven

vaccines that Scott received on October 7, 1996. (Tr. 282

- 86.) Dr. Halsey, with his extensive background in the field of vaccin es and vaccine safety issues, testified that he knew of no evidence whatsoever to support the Dr. Lopez’ theory that one of the vaccines that Scott received could have caused an encephalopathy that began with Scott’s very mild symptoms of

O ctober 17, 1996, but went on to result in Scott’s severe permanent neurodevel opmental disorder. (Tr. 283

- 285 .) Dr. Halsey testified that Dr. Lopez’ proposed scenario is neither plausible n or reasonable. (Tr. 285, 289

- 90.) 15

In short, based on the record as a whole I must reject the essence of Dr. Lopez’ opinion, that based upon the symptoms that Scott experienced about October 17, 1996, he suffered a

vaccine

- caused encephalopathy that also caused hi s permanent, severe neurodevelopmental disorder. That theory of Dr. L opez seems extremely unlikely on its face, because it is based

15 Petitioners asserted in their post

- hea ring brief that Dr. Halsey “conceded” that it would be “plausible” that a vaccine “might” cause an encephalopathy “that occurred within a few days of vaccination.” (Post

- Trial Memo, p. 11, para. 59; see Tr. 284

- 85.) But Dr. Halsey then went on specifical ly to explain that there was no reason to suppose that the type of mild symptoms displayed by Scott about October 17, 1996, were evidence of an encephalopathy. (Tr. 285, 289

- 90.)18 upon such mild reported symptoms. T hat theory is also contradicted by the diagnosis of “teething” made by Scott’s own treating pediatrician on October 17. (Ex. 3.4, p. 1.) And, finally, Dr. Lopez’ theory was convincingly refuted by two well

- credentialed experts,

Drs. Halsey and Wiznitzer. I reject Dr. Lopez’ theory.

VIII

DR. FRANZ’ OPINION DOES NOT CHANGE MY CONCLUSION

As previously noted, Petitioners rely not only upon the expert opini on of Dr. Lopez, but also upon t he opinion of Dr. Cornelia Fran z, who was Scott’s treating pediatrician. Dr. Franz did

not tes tify at the evidentiary hearing. Instead, she supplied an affidavit, which stated that “[b]ased on my 25 years of experience as a pediatrician, and after reviewing the photographs and DVD footage supplied to me, it is my opinion that Scott Patrick Franklin * * * was developing normally and meeting appropriate milestones for his age at 11 months. He thereafter suffered

some form of neurologic injury, which resulted in loss of language and regression in behavior and most likely permanent injury to his brain.” (Pet. Ex. 39 at 2.) Dr. Franz added that Scott’s neurodevelopmental disorder “would be consistent with an encephalopathic re action to vaccination,” and that “more likely than not his neurological damage was caused by encephalopathy after vaccination.” ( Id .)

Dr. Franz is a board

- certified pediatrician with over 25 years of practice, and has treated Scott herself. (Ex. 39, p. 1.) Accordingly, I greatly respect her opinion, and have given it

careful consideration. 16 However, in my final analysis, I find that Dr. Franz’ opinion i s strongly outweighed by the rest of the evidence in the record concerning the causation issue, particularly the testimony of Drs. Halsey and Wiznitzer.

In this regard, I note that not only did Dr. Franz not testify, but she also did not set forth

in her written opinion any detailed explanation concerning why she believes that Scott’s neurodevelopmental disorder was vaccine

- caused. (See Ex. 39.)

In support of her opinion, Dr. Franz gave the following explanation in her affidavit. She noted that she compared photographs of Scott taken in July of 1996, to photos taken on

December 25, 1996. (Ex. 39, p. 1, paras. 5

- 6.) She also compared videos of S cott taken in March and June of 1996 with videos taken in May of 1997. ( Id . at pp. 2

- 3, para. 7.) Dr. Franz explained that while the July 1996 photos and May/June 1996 videos show a normal child, the December 1996 photos and May 19 97 videos show a neurol ogically

- damaged child. ( Id . at pp.

16 In Capizzano v. HHS , the U.S. Court of Appeals for the Federal Circuit stre ssed that “medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether “a logical sequence of cause and effect

shows that the vaccination was the reasons for the injury.’” 440 F. 3d 1317, 1326 (Fed. Cir. 2006) (emphasis added, citation omitted). Similarly, in several cases, judges of this court have, in resolving the Vaccine Act causation issues, relied heavily upon the statements of treating physicians conta ined in the vaccinee’s medical records. See, e.g., Zatuchni v. HHS , 69 Fed. Cl. 612, 623 (2006); Kelley v. HHS , 68 Fed. Cl. 84, 100 (2005).19 2

- 3, paras. 6, 8.) From that difference in the photos and videos, Dr. Franz concluded that Scott must have “suffered some form of neurologic injury” in the meantime. ( Id . at p. 2, para. 9.) She added that such injury “would be consistent with an encephalopathic reaction to vaccination.” ( Id .)

Dr. Franz, however, did not explain why she believes that the neurological change or injury to Scott was caused by a vaccination . She did not explain which vaccine she though t might have caused the injury, nor by what mechanism any vaccine might have caused the injury, nor why she thinks any of the vaccines in question are capable of causing the type of severe neurodevelopmental disorder from which Scott suffers. Given these deficiencies in her affidavit, I cannot conclude that she made a persuasive causation argument.

Moreover, I must give Dr. Franz’ opinion far less weight than the opinions of

Drs. Wiznitzer and Halsey, who not only wrote detailed reports refuting Dr. Fra nz’ causation conclusion, but were willing to testify in order to explain their views at length, and were able to do so in a highly persuasive manner.

Dr. Wiznitzer also specifically addressed Dr. Franz’ affidavit in his hearing testimony

, convincingly p ointing out the flaws in Dr. Franz’ approach to the case. (Tr. 244

- 45, 261

- 62.) As an expert in diagnosing autism

-- in contrast, there is no evidence that Dr. Franz has any special experience concerning autism

-- Dr. Wiznitzer disagreed with the way in whic h Dr. Franz used photographs to come to a conclusion about Scott. (Tr. 244

- 45, 258

- 59.) Dr. Wiznitzer also addressed what seems to be the reasoning implied in Dr. Franz’ affidavit

-- i.e. , that because Scott seemed normal, then later seemed autistic, he mu st have suffered a neurological injury in the meantime. (Ex. 39, p. 2, para. 9. ) Dr. Wiznitzer explained why t hat is faulty reasoning, and his explanation was persuasive. (Tr. 261

- 62.)

In short, while I respect the opinion of Dr. Franz’, I found that it was strongly outweighed by all of the contrary evidence in this case.

IX

“SIGNIFICANT AGGRAVATION” SUGGESTION

In their “Amendment to Petition” filed on June 4, 2008, Petitioner s stated an “alternative” position in the case, namely that “in the alternative, if any disease process [already] existed [in Scott] at the time of vaccination, the vaccination itself was of substantial significant aggravation of such condition.” However, Petitioners since then have argued only that one of Scott’s October

1996 vaccination s originally caused his neurodevelopmental disorder, and have not argued “significant aggravation” as an alternative claim.

Moreover, I find no substantial evidence of “ aggravation” in the record. Petitioners clearly have failed to demonstrate that Scott’s disorder, be it labeled autism or otherwise, was aggravated by any vaccination.20 X

PETITIONERS ’ CASE FAILS THE ALTHEN TEST

As noted above, in its ruling in Althen , the U.S. Court of Appeals for the Federal Circuit

discussed the A causation

- in

- fact @ issue in Vaccine Act cases. The court stated 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 th e reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. If Althen satisfies this burden, she is A entitled to recover unless the [government] shows, also by a preponderance of evidence, that the injur y was in fact caused by

factors unrelated to the vaccine. @

Althen , 418 F.3d 1274, 1278 (Fed. Cir. 2005) (citations omitted). In the pages above, of course, I have already set forth in detail my analysis in rejecting Petitioners ’ A causation

- in

- fact @ theor y 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 sentence of the Althen excerpt set forth above. The short answer is that I fi nd that Petitioners ’ theory in this case clearly does not satisfy any of the parts of the Althen test.

A. Relationship between Althen Prongs 1 and 2

One interpretative 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 A (1) a medical theory causally connecting the vaccination and the injury, @ and A (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 demo nstration of a

A causal @ connection between A the vaccination @ and A 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 A can cause @ vs. A did cause @ distinction. That is, in many Program opinions issued prior to Althen involving A 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 q uestion, 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 A can cause @ requirement, and Prong 2 of Althen is the A 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 F ederal Circuit c onfirmed that interpretation in Pafford , ruling explicitly that the A can it?/did it? @ test, used by the special master in that case, was equivalent to21 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 petit ioner must demonstrate that it is A 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 A preponderance of the evidence. @ ( ' 300aa

- 13(a)(1)(A).) And, whatever is the precise meaning of Prongs 1 and 2 of A lthen , in this case the overall evidence falls far short of demonstrating that it is A more probable than not @ that any of the vaccines that Scott received

contributed to the causation of Scott’s tragic neurodevelopmental disorder.

B. Petitioners have fai led 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. In this case, however, the Petitioners have failed to show that any of the vaccines that Scott

received on October 7, 1996, can cause the type of injury from which Scott actually suffers

-- i.e.

, an autism spectrum disorder.

To be sure, the evidence in the case confirms that the wild measles virus can cause a well

recognized condition known as “measles encephalitis” or “measles encephalopathy.” And some experts have su ggested that the attenuated (weakened) form of the measles vi rus contained in the measles vaccine might also be capable of cau sing “measles encephalitis,” th ough that suggestion is unproven. ( E.g. , Tr. 170

- 71 .) However, in this case Petitioners’ own expert Dr. Lopez eventually conceded that Scott did not have “mea sles encephalitis.” (Tr. 274.)

Thus, the Petitioners’ burden in this case under Althen’s Prong 1 would be to show that

one of Scott’s vaccines can cause the type of neurodevelopmental disorder from which Scott actually suffers

-- i.e. , autism. This they have clearly failed to do. As explained above, neither

Dr. Lopez nor Dr. Franz even asserted

, much less demonstrated

, that any of the vaccines Scott received can cause autism. Accordingly, in this case Petitioners have clearly failed to demonstrate Prong 1 of Althen.

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

Under Prong 2 , the Petitioner would need to show that it is “more probable than not” that

one of Scott’s vaccinations did cause Scott’s own severe neurodevelopmental disorder. But this they have failed to do, for all the reasons detailed at pp. 11

- 19 , above. Thus, Petitioners have also failed to establish Prong 2 of Althen in this case.

D. Prong 3 of the Althen test22 Since I have explained why Petitioners have failed to satisfy either of the first two prongs of Althen , I need not discuss why Petitioners’ case also fails to satisfy the third prong.

E. This is not a close case

As noted above, in Althen the Federal Ci rcuit indicated that the Vaccine Act involves a “system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants.” (418 F. 3d at 1280.) Accordingly, I note here that this case ultimately is not
a close case . For all the reasons set forth above, I found that Dr. Lopez’ theory was not at all persuasive, while Respondent’s experts were far more persuasive.

X I

ISSU E OF OAP “GENERAL EVIDENCE,” EXHIBITS Z AND AA

As explained above, Scott has been diagnosed as suffering from the neurodevelopmental disorder known as “autism.” For that reason, Petitioners chose, as described above, to delay the resolution of their case for several years, to await the outcome of the Omnibus Autism Proceeding (OAP). As further de scribed, when the outcome of the OAP test cases was

unfavorable to the vaccine

- causation theories, the Petitioners in this case then chose to rely upon the opinions of Drs. Lopez and Franz. In response, Respondent filed the expert reports of Drs.

Wiznitz er and Halsey, as described, but also sought permission to file certain additional evidence from the OAP test cases into the record of this case. Specifically, on August 30, 2011, Respondent filed excerpts of OAP hearing testimony given by two of responde nt’s experts,

Dr. Diane Griffin and Dr

. Brian Ward. ( Exs. Z, AA.) The issue of whether such excerpts were appropriate to be considered in this case was discussed at length during several status conferences. (See, e.g. , my Orders dated March 28, July 5, August 17, and October 27, 2011.) I permitted the filing of those two exhibits, over Petitioners’ written objection filed on October 3, 2011, because those two experts had testified concerning the potential effects of the measles

virus and measles vaccin e on the human brain, and Dr. Lopez’ theory appeared, at that time , to
be that the measles portion of Scott’s MMR vaccination caused his neurodevelopmental disorder by damaging his brain.

In permitting the filing of those two exhibits, however, I stresse d during the status

conferences that I was not making a final ruling as to whether I would actually utilize those two exhibits in deciding the case. That wou ld depend on the evidence that w as to be presented at the evidentiary hearing on November 30, 2011, and whether the evidence in the two exhibits proved

to be relevant to Dr. Lopez’ theory as presented at the evidentiary hearing. I further stressed that

we would revisit the issue of the relevance of the two exhibits at the conclusion of the evidentiary hearing, and, if necessary

, in the parties’ post

- hearing brief s

. 17

Ultimately, however, I concluded that the two exhibits in question were not relevant to the Petitioners’ theory, as final ly clarified by Dr. Lopez during the November 30 hearing. Those

17 I note that the evidentiary hearing was originally scheduled for two days, November 30 and

December 1, 2011, but actually was finished by the close of the first day.23 exhibits, therefore, played no role whatsoever in my resolu tion of this case. Once I hear d

Dr. Lopez’ clarification of this theory during the November 30 hearing, and the refutation of that theory by Respondent’s experts during that hearing, I concluded that there was no relevance to the two exhibits, because, as explained above, Dr. Lopez clarified that his theory was not related specifically to the measles vaccine.

Similarly, no expert fo r either side referred to Exs. Z and AA during the evidentiary hearing, and in the post

- hearing briefs of both parties, no references were made to Exs. Z and

AA.

Accordingly, I did not review Exs. Z and AA in the course of resolving this case. Those

exh ibits played no role in my analysis of this case, which was based solely on the presentations of the experts upon whom the parties did rely

-- i.e. , Drs. Lopez, Franz, Halsey, and Wiznitzer. 18

XII

PETITIONERS’ OTHER ARGUMENTS

I also briefly ad dress several points raised by P etition ers in their post

- hearing brief , filed on April 30, 2012.

A. “Objective confirmation” argument

For example, Petitioners note, correctly, that no “objective confirmation” is required to establish proof of vaccine

- causation. (Brief at 22.) However, I have not required any such “objective confirmation.” I have required Petitioners only to demonstrate that it is “more proba ble than not” that Scott has a vaccine

- caused injury

-- but they have failed, by far, to do so.

B. “Alternative ca u se” argument

Petitioners also seem to argue that Respondent failed to pinpoint a cause, other than the vaccines, for Scott’s tragic disorde r. However, the identification of a cause was never Respondent’s burden. Petitioners never came close to fulfilling their burden of establishing a prima facie case of causation under the Althen test, so the burden never shifted to Respondent to point to an alternative cause.

C. Banks opinion

Petitioners, in addition, discussed at length the case of Banks v. HHS , 2007 WL 2296047

, 2007 U.S. Claims Lexis 254 (Fed. Cl. Spec. Mstr. July 20, 2007. ) The Banks opinion is, indeed, an interesting one, but in the final analysis it is so different from this case that it offers no

substantial assistance to Petitioners’ case here.

18 In other words, I resolved this case solely upon the record of this case, without reference to any

evidence from the OAP record.24 To be sure

, in Banks , the same Dr. Lopez was the primary expert witness for the petit io ners, and the special master , based in part upon Dr. Lopez’ testimony, did conclude that an infant’s severe neurodevelopmental disorder, which appears to have been a form of autism, was caused by a n MMR inoculation. But the facts of that case were far d ifferent from those here. For example, in Banks , the infant experienced a significant seizure, a clear sign of brain malfunction, 16 days after the MM R inoculation. (2007 WL 2296047 at *2.) In this case, in contrast, Scott exhibited only the very minor symptoms described above , about 10 days post

inoculation, which were diagnosed b y his pediatrician merely as evidence of “ teething. ”

As another example, the Banks infant had a brain scan done on the day after the above

mentioned se izure, only 17 days pos t

- vaccination

, and on that scan positive evidence of a demyelinating process was found. ( Id . at 3.) In this case, in contrast, there exists no such clearcut evidence of brain malfunction in the period soon after inoculation. Further, in Banks

, the speci al master found that the infant’s autism was the result of a specific neurologic condition known as “ADEM” ( id . at *15), and the Respondent’s expert in that case acknowledged that it was “biologically plausible” that the measles vaccine could trigger ADEM ( id . at 13). No

similar circumstances exist in this case.

In short, the Banks case involved facts far different from this case. And Dr. Lopez’ causation theory offered in Banks appears to have differed greatly from his theory offered in this

case. Fur ther, in Banks , the special master was not presented with the expert testimony of Drs. Wiznitzer and Halsey, which I found to be so persuasive in this case. Accordingly, while I find

the Banks opinion to be interesting, and I respect the special master who issued it, I do not find

that the Banks opinion offers any substantial support for the very different causation theory advanced by Dr. Lopez under the far different facts of this case.

D. Hannah Poling case

Petitioners also point to a Vaccine Act case involving a child named Hannah Poling, in which Hannah’s family received a Program award on her behalf

. (Brief at 25

- 28 ; see also fn. 1

, p. 11 of that Brief. ) Petitioners argue that Scott’s case is similar to the Poling case. This argument, however, is also without merit.

First, Petitioners, rather strangely, do not cite to any opinion or decision, published or otherwise, in the Poling case. They did not attempt to file into the record of this case any

documents from the Po ling case, or about Hannah Poling. They do not cite to any part of the record of this case in which any of their experts discussed or commented on the Poling case. Petitioners’ counsel, rather, simply asserts, without say ing why, that “the facts of the P oling case are probably familiar to all with any association to the vaccine court.” (Brief at 25.)

Petitioners go on to describe certain facts that they assert to be facts of the Poling case. ( Id . at 25

- 26.) They even place quotation marks around a ph rase that allegedly describes

Hannah ’s diagnosis, without saying what they are “quoting” from. ( Id . at 26.) Petitioners argue

that the fact s of this case and the Poling case are similar to each other, and therefore I should

make an award on Scott’s behalf.25 Petitioners’ argument in this regard must be rejected, for many reasons. First, it is highly inappropriate as a matter of law that, after the ev iden tiary record in this Franklin case was closed, Petitioner s should simply allege facts about another case

, without stating where t he y obtained those alleged facts. I must reject this argument for that reason alone.

Further, a public document relating to that Poling case does in fact exist

, which is a published opinion relating to a procedural issue in that case

-- Poling v. HHS , No. 02

- 1466V, 2008

WL 1883059 (Fed. Cl. Spec. Mstr. April 10, 2008). 19 That published opinion does not set forth in any detail the facts of the Po ling case, but it does briefly explain that compensation was

awarded in Poling because the Respondent conceded that the facts of that case demonstrated that a vaccination “significantly aggravated an underlying mitochondrial disorder” in Hannah. ( Id . at *1.)

Thus, from the only published opinion that shed s any light at all on the Poling case, the only facts that we know make it clear that the Poling case was, in fact, far different from this

case

-- i.e. , Hannah Poling had an “un derlying mitochondrial dis order.” Such a disorder is not alleged in Scott’s case. Further, we know that the special master in Poling did not make a finding that a vaccine aggravated Hannah’s disorder, but rather the Respondent conceded the case, for reasons unexplained.

Therefo re, in my view, the Petitioners’ argument in this case concerning the Poling case is late, completely unsupported, and offers no support at all for the contention that Scott Franklin

has suffered a vaccine

- caused injury.

E. Arguments concerning Dr. Wiznitzer

Petitioners further complain that Dr. Wiznitzer, while clearly an expert on autism, is “biased” in that he has frequently testified for the Respondent in Vaccine Act cases, but has never testified for a petitioner in an actual Vaccine Act heari ng. (Brief at 28.) Dr. Wiznitzer explained, however, that in a number of cases he was asked to support the Respondent’s position in a Vaccine Act case, but could not do so. (Tr. 215

- 16.) He has also supported vaccine

causation cases of a number of hi s own patients. (Tr. 214

- 15.) T o be sure, Dr. Wiznitzer clearly does not agree with those who believe that a substantial number of cases of autism in this country have been caused by vaccinations. However, I have found that, in each case in which he

has t estified before me, Dr. Wiznitzer closely examined the facts of the case, used his considerable medical expertise to analyze those facts, and presented his honest opinion concerning the case. I do not find that he has been a “biased” witness in this or an y other case.

Finally, Petitioners’ brief also argues, without any citation whatsoever to the record in

this case

, that Dr. Wiznitzer erred concerning the issue of “eye contact” by Scott. (Brief at 29.) Without citation to the record, I have not locate d this allegedly mistaken testimony. In any event, b ased on the overall record of this case, I find that Dr. Wiznitzer was a very knowledgeable and persuasive witness, far more persuasive than Petitioners’ witness es

.

19 I also found another published opinion from that same Poling case, bu t that relates only to an attorneys’ fees award. See Poling v. HHS , No. 02

- 1466V, 2011 WL 678559 (Fed. Cl. Spec. Mstr. Jan. 28, 2011).26 X II I

CONCLUSION

The record of this case demonstrates plainly that Scott Franklin and his family have been through a tragic medical ordeal. They are certainly deserving of great sympathy. Congress, however, designed the Program to compensate only the individuals whose in juries or deaths can be linked causally, either by a Table Injury presumption or “ causation

- in

- fact ” evidence, to a listed vaccine. In this case, as described above, no such link has been demonstrated. Accordingly, I conclude that the P etitioners in this case are not entitled to a Program award. 20

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

20 In the absence of a timely

- filed motion for review of this Decision, the Clerk of the Court shall enter judgment accordingly.