# In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 06

- 371 V Filed: August 26 , 2014 (To be published 1 )

* * * * * * * * * * * * * * * * * * * * * * * * * FRANCIA HIRMIZ and PETER HIRMIZ, * Vaccine Act Entitlement;

as best friends of their daughter, * Causation

- in

- fact; Influenza vaccine;
J.H., * Developmental Delay; Degeneration

* of Motor Skills and Body Control.

Petitioner s , *

*

v. *

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES *

*

* Respondent. *

*

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

John F. McHugh, New York, NY, for Petitioners.

Linda Renzi , U.S. Department of Justice, Washingto n, DC, for Respondent

.

DECISION

HASTINGS, Special Master

.

This is an action in which the P etitioner s , Francia Hirmiz and Peter Hirmiz, seek an award under the National Vaccine Injury Compensation Program (hereinafter “the Program ” 2 ), on account of neurological degeneration in their daughter J.H., which they believe was caused by

1 Because I have designated this document to be published, this document will be made available to the public unless petitioner s file , 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).

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

- 1 0 et seq . (2006 ). Hereinafter, for ease of citation, all “§” refer ences will be to 42 U.S.C. (2006 ).

1two half

- dose influenza vaccines administered on October 14 and November 16, 2004 . For the reasons set forth below, I conclude that P etitioner s are not entitled to an award.

I

APPLICABLE STATUTORY SCHEME AND CASELAW

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 showings that an individual received a vaccination covered by the statute; received it in th e United States; suffered a serious, long

- lasting 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 betwe en 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 enumerate d in the “ Vaccine

I njury 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 automatical ly 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 recip ient 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 b y showing that the recipient ’ s injury was “caused

- in

- fact” by the vaccination in question. ( §300aa

13(a)(l)(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 petitione r to intr oduce evidence demonstrating that the vaccination actually caused 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 “prepo nderance of the evidence” standard, the same standard ordinarily used in tort litigation. ( §300aa

- 13(a)(l)(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 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 vacc ination 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 form of scientific studies or expert medical testimony.” ( Al then , 418 F.3d at 1278; Grant v. HHS

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

2The 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 a proximate temporal relationship between vaccination and in jury. If Althen satisfies this burden, she is “entitled to recover unless the [government] shows, also by a preponderance of 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 i ndicated that, in finding causation, a Program factfinder 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 claima nts.” ( 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 treat ing 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 conclus ive 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), consid ered 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 dia gnosis 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 suppo rts a claimant's theory of causation. Doe 11 v. HHS , 60 1 F.3d 1349 (Fed. Cir. 2010) and Deribeaux v.

3HHS , 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.

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 con cerning 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 theori e s presented in Program cases.

II

PROCEDURAL HISTORY

On May 8, 2006, Francia and Peter Hirmiz filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986, as amend ed. The original petition alleged that a series of vaccinat ions administered in 2004 caused J.H. to experience "a degeneration of her motor skills and body control noticeable after mid

- Oct ober of 2004." (Pet. at p. 1.)

Respondent filed a “Rule 4 Report” on July 14, 2006 , contesting the claim.

On March 5, 2007 , Petitioners filed an amended petition ("Am. Pet.") that altered their original claim of onset of J.H.'s condition. Specifically, Petitioners changed their initial

assertion that “ J.H. progressed n ormally for about eight months,” to allege that she “ pro gressed normally for about over ten months, i.e. at least until O ctober 14, 2004." (Pet. at 1; Am . Pet. at 2.) In ad dition, the amended petition alleged t hat J.H. 's failure to progress resulted from the

half

- dose influenza v accines that she received on Oc tober 14 and November 16, 2004. (Am. Pet., p. 3 .)

An “onset hearing” was held before Special Master Abell on August 28, 2008. Both Petitioners testified regarding the onset of J.H.'s condition. (ECF No. 37.) Special Master Abell

is sued a bench ruli ng on January 14, 2010, finding that the onset of J.H.'s symptoms occurred

betwe en July 16 and October 14, 2004, prior to the receipt of her half

- dose flu v accine

administered on October 14. ( See Transcript of Proceedings (ECF No. 56) (“Abell Tr.”),

Janua ry 14, 2010; see also Find ings of Fact, March 26, 2010.) Significantly, Special Master

Abell found that the onset of J.H. ’ s developmental delays occurred between six and nine months of age, and that concerns were noted prior to her receipt of the first ha lf

- dose of flu vaccine. (Abell Tr. 12

- 13.)

This case was then reassigned to me on March 29, 2010, following Special Master

Abell’s retirement. (ECF No. 58.)

4Subsequently, on January 9, 2012, Petitioners fil ed an expert report by James Ol e s ke, M.D., accompanied by Dr. Oleske’s curriculum vitae

. (Ex s. 15, 16.) 3 On May 9, 2012, Respondent filed an expert report and curriculum vitae of Stephen J. McGeady, M.D. (Exs. A, B.) An additional report by Dr. Oleske responsive to Dr. McGeady's report w as filed on September 10, 2012. (Ex. 17.) On December 5, 2012, I conducted an evidentiary hearing in

N ew York, New York, to receive testimony from the experts in this case. ( See Transcript o f Proceedings (ECF No. 104) (“3

- Tr.”) (December 5, 2012.) Drs. Oleske and McGeady were the only two witnesses to testify at that time. ( Id .)

The parties then submitted po st

- hearing briefs. Petitioners’ post

- hearing memorandum was filed on May 15, 2013 (ECF No. 109), and Respondent's memorandum on August 22, 2013 (ECF No. 112). Petitioners filed a re p ly brief on October 9, 2013. (ECF No. 115.)

III

FACTUAL HISTORY

J.H. was born on January 12, 2004 , along with her twin brother . (Ex. 4, p. 15.) During her initial months of life, J.H. appeared to be developing normally. She had well

- child exams by

Dr. Peera at age sixteen days and age six months. (Ex. 4, pp. 25

- 26.) No concerns regarding her development were noted. ( Id .) She received variou s vaccinations on March 15, May 17, and July 16, 2004. ( Id ., pp. 10

- 12.) No adverse reactions to any immunizations were recorded. ( Id .)

During her pediatric visit of July 16, 2004, the pediatrician checklist indicated that she

was rolli ng over in both directions and “sits with support / alone.” (Ex. 4, p. 25; Ex. 10, p. 7. 4 ) However, when she returned on October 14, 2004, concerns about developmental delays were

noted. (Ex. 4, p . 24; Ex. 10, p. 5.) Specifically, J.H. was not roll ing over, and not sit ting alone. ( Id .) T hat new inability to roll over and to sit indicated some loss of skills between July and October 2004. It was also stated in the medical note of October 14, 2004, that J.H. had decreased muscle tone at that visit, and she received a h alf

- dose of the influenza virus vaccine at that time. ( Id .)

A pproximately one month later, on November 16, 2004, J.H. received a second half

- dose

of the infl uenza vaccine (Ex. 4, p. 10(a); Ex. 10, p. 10), and was referred to a neurologist.

J.H.'s init ial neurological evaluation occurred on December 20, 2004, and was performed by Dr. Stumpf. (Ex. 4 , p. 371.) Dr. Stumpf observed that J.H. was socially and cognitively age

3 Exhibits filed by Petitioners were mostly designated by number. Exhibits filed by Respondent were designated by

letter.

4 Ex. 4, pp. 24 and 25 are co pies of the original records of J.H.’s pediatric visits on July 16, and October 14, 2004. Ex. 10, pp. 5 and 7, are copies of Dr. Peera’s “transcriptions” of the sometimes illegible portions of the originals.

5appropriate, but diagnosed her with spastic diple gia and cerebral palsy. ( Id .) D r. Stumpf opined that J.H.’s cerebral palsy stemmed from “twinning.” ( Id .)

On January 18, 2005, J.H. had her 12

- mo n th well

- child pediatric visit. (Ex. 10, p. 9.) T he medical records note that, at that time, J.H. was unable to pull to stand, walk independently, or grasp objects. ( Id .) The records also noted that J.H. could use sing le words, drink from a cup with help, and f eed herself some solids. ( Id .) The doctor's assessment was “ well developed but

wit h muscle weakness, motor delay.” ( Id .) T he doctor’ s plan for J.H. was to follow up with neurology. ( Id .)

I n early 2005, J

. H

. was a lso attending physical therapy. Notes from her medical records indicate that although she was “ not using her bilateral extremities as functionally as she used to, ” her parents reported “ improvement in prone activity, sitting and lower limb kicking.” (Ex. 6,

p. 469.) This record indicates that “ J.H. has been making progress since physical therapy has been initiated.” ( Id .)

J.H. thereafter deteriorated neurologi cally over the ensuing year, and she was evaluated and treated extensively by numerous physicians, including neurologists, geneticists, pediatricians, orthopedic surgeons, and physical and rehabil itation specialists at Children’s Memorial Hospital. ( See g enerally Ex. 6.)

In late March 2005, J.H.’ s parents and her physical therapist noted a loss of milestones, difficulty feeding, a nd the onset of clenched fists. (Ex. 4, p. 356.) She returned to Dr. Stumpf on April 18, 2005, and he observed a significant increase in spasticity, which he attributed to her underlying cerebral palsy and the ma turation of her nervous system. ( Id .) However, he noted that because of the rapid progression, additional tests were needed to determine whether J.H. had a degenerati ve disorder. ( Id .)

In May 2005, swal lowing function studies and MRIs with contrast of the brain and

c ervical cord were administered and deemed normal. (Ex. 4, pp. 318, 347

- 48.) In June 2005,

J .H. also had a nor mal EEG. (Ex. 4, p. 318.) By June 2005

, J.H. had deteriorated to the extent that, as no ted in a June 2005 Rehabilitation Institute of Chicago assessment, she “ had very poor head control, trunk control.” (Ex. 4, p. 334.) J.H. was at that time diagnosed with “ spastic quadriplegia, etiology unc lear.” ( Id .) Additionally, despite physical therapy, J.H. ’s motor function worsened. ( Id ., pp. 324

- 25.)

In November 2005, however, J.H. was seen for an evaluation at the Mayo Clinic, since her doctors could not agree upon a specific genetic or metabolic defect had been found to explain her deteriorating neurological status. Despite extensive testing at the Mayo Clinic, J. H. still had no confirmed diagnosis

. ( See generally Ex. 5.)

In 2008, J.H. was seen and evaluated by Mark Geier, M.D. Dr. Geier performed further testing to procure an etiology or diagnosis for J.H.’ s condition, including a whole genome microarray, bu t he also offered no diagnosis. (Ex. 8, p. 737.)

6The parties agree that, to date, there has been no definitive diagnosis for J.H. ’s condition. ( See, e.g ., Ex. 15, p. 2; Ex. A, p. 11.)

IV

ISSUE TO BE DECIDED

In this case, Petitioner s seek a Program award, contending that their daughter’s neurological degeneration, including loss of motor skills and body control, was “caused

- in

- fact” by the two half

- dose influenza vaccines that J.H. received on October 14 and November 16,

2004. After careful consideration, I conclude that Petitioner s have failed to demonstrate

causation.

Petitioners’ theory of the case, while never very coherent ly organized by their expert,

Dr. Oleske, may be brie fly summarized as follows. Petitioners contend that the onset of J.H.’ s condition occurred i n two distinct phases that temporally corresponded with the administration of

her two half

- doses of flu vaccine on October 14, 2004, and November 16, 2004, creating what is known as a “challenge

- rechallenge event,” a circumstance in which a vaccine provoke s the same

respons e on two independent occasions. Petitioners allege, particularly in the absence of any

other known etiology explaining J.H.’s condition, that “ ch allenge

- rechallenge” is proof of

causation. Petitioners also seem t o contend that a defect in J.H.’s immune system contributed to her neurologic deterioration.

Respondent disagrees. Respondent disputes Petitioners’ claim that J.H.’s condition developed following J.H.’ s first half

- dose of flu vaccine, arguing that her medical records show

that the onset of her developmental delay occurred prior to her flu v accination of October 14, 2004. Respondent’ s exper t also disputed the Petitioners’ “ challenge

- rechal lenge” theory, as well

a s various aspects of Dr. Oleske’ s causation presentation. Responde nt argues that Petitioners

have not demonstr ated a causal link between J.H.’ s condition and her flu vaccinations.

After carefully considering all of the evidence in the rec ord, I must reject Petitioners’ claim that her degenerative neurological disorder was caused or exacerbated by the two half

doses of influenza vaccination that J.H. received on October 14 and November 16, 2004.

Petitioners have fa iled to demonstrate that it is “more probable than not” that this pair of

vaccinations contri buted to causing their daughter’s condition. Instead, it appears more likely

than not that J.H.’ s condition predated these vaccinations.

V

SUMMARY OF EXPERT WITNESSES’ QUALIFICATIONS AND OPINIONS

In this case, each side presented the expert reports a nd hearing testimony of one medical expert. At this point, I will briefly summarize both the credentials and the opinions of these expert witnesses.

7A. Petitioner s ’ expert

1. Dr. James M. Oleske, M.D., MPH

Dr. Oleske attended the University of Detroit from 1963

- 1967 and received a Bachelor of Science degree. (Ex. 16, p. 1.) From 1967

- 1971, Dr. Oleske attended the College of Medicine and Dentistry of New Jersey in Newark, New Jersey, where he graduated with a degree in medicine. (Ex. 16, p. l; 3

- Tr. 4.) Dr. Oleske then went on to receive a Ma ster’ s of Public Health degree fr om Columbia University in 1974. (Ex. 16, p. 1.) Dr. Oleske served as a student research fellow from 1968 to 1970 at the College of Medicine an d Dentistry of New Jersey,

D epartment of Pediatrics. ( Id .) He interned and served as a resident at the College of Medicine and Dentistry of New Jersey, Department of Ped iatrics, from 1971

- 1973. ( Id .) His research fellowship took place at E mory University from 1974

- 1976. (Ex. 16, p. 1; 3

- Tr. 4.) He thereafter served at Emory as a clinical instru ctor and fellow from 1974

- 1976. (Ex. 16, pp. 1

- 2.)

Dr. Oleske was licensed to practice medicine by the state of New Jersey and by the New

J ersey Laboratory Director . (Ex. 16, p. 2.) He is certified by the Specialty Board of the American Board of Pediatrics, Sub

- Specialty Board of the American Board of Allergy/ Immunology, the Sub

- Specialty Board of the American Board of Pediatrics and Pediatric Infectious Diseases, and the American Board of Medica l Laboratory Immunology. ( Id .) He also is certified by the American Board of Hospice and Palliative Care, the American Academy of Pain Management, the Council of Certification of IRB Professionals, and the American Academy of HIV Medicine. (Ex. 16, p. 2; 3

- Tr. 4.)

Dr. Oleske is currently serving as a Professor at the School of Public Health at the University of Medicine and Dentistry of New Jersey, as a Clinical Professor at the New Jersey

School of Nursing, and as a Professor of Preventive Medicine and Pathology in the Department

of Pediatrics at the University of Medici ne and Dentistry of New Jersey. (Ex. 16, p, 3.) He also currently wor ks as a consultant at the Allergy and Immunology & Infectiou s Diseases Matheny School and Hospital in Peapack, New Jersey. ( Id .) Dr. Oleske’ s resume lists 21 2 peer

- reviewed publications. ( Id. , pp. 19

- 33.)

2. Summary of opinion of Petitioner s ’ expert

Dr. Oleske stated in his fi rst expert report that J.H.’s neurologic condition is likely due to “the multiple immunizations she received, in particular the two

, half dosages of influenza vaccine she received at 9 and 10 mos. of age,” in October and November of 2004. (Ex. 15, p. 2,

sic .) In his second expert report (Ex. 17) and his hearing testimony, Dr. Oleske continued to focus primarily on the two influenza vaccinations, arguing that those vaccinations were

t emporally related to the onset of J.H.'s sudden and prog ressive neurological condition. (Ex

. 17, pp. 1

- 2; 3

- Tr. 5.)

Dr. Oleske’ s testified that th e basis for his conclusion was “ a clear onset of real

n eurological findings after the first [influenza] dose with very marked worsening after the second dose.” (3

- Tr. 5 .) Dr. Oleske also testified that “[a]t 12 months, [ J.H. ’ s growth ] w as in the

8normal range, but at 15 months she was down between 15% and 20% * * *, the consequences of

a severe event that occurred around 12 months. ” (3

- Tr. 20.)

Additionally, Dr. Oleske opined that the immune studi es that were done in 2008 showed

immune abnormalities in J.H. (Ex. 15, p. 2.) Dr. Oleske opined that these immune

abnormalities “could have been due” to an unusual immunological response to the flu vaccine

that has also caused her neurological deteriora tion. (Ex. 15, p. 3 .)

Dr. Oleske also speculated in his initial report that J.H.'s condition "may well" have been the consequence of a “missed SIDS” episode (“Sudden Infant Death Syndrome”). (Ex. 15, p. 3.) This theory appears to have been abandoned, however, as Dr. Oleske ultimately testified that he found no evidence of a missed SIDS epis ode in this case. (3

- Tr. 96

- 97.)

B. Respondent’s expert

1. Dr. Stephen J. McGeady, M.D.

Dr. Stephen McGeady attended Fordham University where he received a Bachelor of

Sci enc e Degree in Biology in 1963. (E x. B, p. 1; 3

- Tr. 73

- 74.) He attended Creighto n University w here he gr aduated in 1967 with a degree in medicine. (Ex. B, p. 1; 3

- Tr. 74.)

Dr. McGeady ser ved as a rotating intern at the St. Vincent's Hospital in New York from

1 967

- 1968. (Ex. B, p. 1; 3

- Tr. 74.) He served as a resident in Pediatrics at the St. Christopher's

H ospital in Phi ladelphia from 1970

- 1972. ( Id .) He served as a fellow at Duke Univ ersity in the

P sychiatry an d Allergy unit from 1972

- 1974. (Ex. B, p. 1.) He has been appointed Director of

Ped iatric Services at the Children’ s Heart Hospital in Philadelphia, Medical Director at the

Children’ s Heart Hospital, Medica l Director of the Ch ildren’s Rehabilitation Hospital in

P hiladelphia, and Medical Director o f the Jefferson Park Hospital. (Ex. B, p. 1.) He serves as

the Director of the Allergy and Clinical Immunology Training Program at the Jefferson College of Medicine. (Ex. B, p. 1; 3

- Tr. 74.) Currently, Dr. McGeady also serves as the Chief of the Allergy, Asthma, and Immunology Division, at the DuPont Hospital for Children in Wilmington, Delaware. (Ex . B, p. 1; 3

- Tr. 73.)

Dr. McGeady is certified by the American Board of Pediatrics , the American Board of Allergy and Immunology, and the Board of Diagno stic and Laboratory Immunology. (Ex. B, p. 11; 3

- Tr. 74.) He is licensed in Pennsylvania, Delawar e, and New Jersey. (Ex. B, p. 1.)

Dr. McGeady’s resume lists 54 peer rev iewed ar ticle s. (Ex. B, pp. 2

- 6 .)

2. Summary of opinion of Respondent’s expert

Dr. McGeady opined that there "is no clear association of any specific vaccine with the onset of [J.H.’ s] neurological det erioration, nor can a precise time of onset of her deterioration be established.” (Ex. A, p. 4; see also 3

- Tr. 76

- 77.) Dr. McGeady could find no evidence in the medical records that J.H. had any sort of immune dysfunction in her first six months of life, and

9testified that she received routine immunizati ons during that time without any reported adverse reaction. (3

- Tr. 77.)

Dr. McGeady further opined that J.H. showed signs of loss of skills between July and

October of 2004, prior to the flu vacci nations in question. (Ex. A

, p. 4.) While J.H.’ s abilit y to
roll over and to sit up had been described in the pediatric note of July 16, 2004 (Ex. 10, p. 7), in

the note of her visit of October 14, 2004, those skills wer e noted to be missing (Ex. 10, p. 5), indicating a loss of skills (Ex. A, p. 4). Dr. McGea dy also pointed to the notation of decreased

muscle tone in the lower extremities in the October 14, 2004 not e, and the fact that a referral for occupational/physical therapy was to b e considered at the next visit. (Ex. A, p. 4.) Dr. McGeady

noted that f or an infant not to have made significant physical skill acquisition between the ages of six and nine months (July to October of 2004) would be highly abnormal , and to have lost

s kills in that time period would b e alarming. (Ex. A, p. 4; 3

- Tr. 83

- 84.) An d since the first

influenza immuniza tion was given during the visit of October 14, 2004, he concluded that it is not possible that the influenza vaccines could have been responsible for J.H.’ s deteriorating neurological status, which began before that visit. (Ex. A, pp. 4

- 5.) Dr. McGeady opined that it seems likely that the perceived rapid deterioration beginning in late 2004 was merely an

e x tension of a neurodegenerative process already in motion prior to October 14. (Ex. A, p. 5.)

Dr. McGea dy also p ersuasively disagreed with the “immune dysfunction” and “challenge/rechallenge” arguments put forth by Dr. Oleske.

VI

SUMMARY OF MY OPINION

After reviewing the record of this cas e, I have found that Dr. Oleske’ s view of the case was quite unpe rsuasive, while Dr. McGeady’ s opinion was far more persuasive. There are

several reasons for this conclusion.

First and foremost, Dr. Oleske based h is opinion on a plainly flawed assumption as to the

time of o nset of J.H.'s neurological symptoms. Dr. Oleske concluded that J.H.’ s symptoms began shortly after her flu vaccination of O ctober 14, 2004. However, J.H.’ s medical records show quite clearly that, as Dr. McGeady concluded, J.H.’ s symptoms began between July and October of 2004, prior to her first flu vaccination.

Second, there were a number of additio nal deficiencies in Dr. Oleske’ s testimony.

Dr. Oleske simply failed to offer any persuasive testimony as to why one should conclude that

J.H.’ s flu vaccinations might have caused her neurolog ic deterioration. Dr. Oleske offered testimony that J.H. might have an immune dysfunction, but that theory was persuasively refuted by Dr. McGeady. Dr. Oleske offered testi mony concerning the concept of “ challenge

rechallenge,” but that testimony was also strongly refuted. Dr. Oleske's testimony was, in general, vague and wholly unpersuasive, while that of Dr. McGeady was clear and persuasive.

10VII

DR. OLESKE’S OPINION IS BASED ON A CLEARLY FLAWED ASSUMPTION

AS TO THE ONSET OF J.H.’S NEUROLOGICAL DETERIORATION

As summarized above, the most g laring deficiency in Dr. Oleske’ s causation opinion in this case is that Dr. Oleske based his opinion on a plainly flawed assumpti on as to when the onset of J.H.’s neurological symptoms began. Dr. Oleske concluded that J.H.’ s symptoms began shortly after her flu vaccination of October 14, 2004, and sharply increased aft er her vaccination

of November 16, 200 4. However, J.H.’ s medical records show quite clearly that, as Dr. McGeady concluded, J

. H

. ’ s sympto ms instead began between July and October of 2004,
prior to her first flu vaccination.

In regard to this issue of the onset of J.H.’ s symptoms, in the unusual procedural posture of this case, another special master of this court has already studied the o nset issue, and has indicated an understanding of the onset history that is plainly at odds with the onset assumption upon which Dr. Oleske based his opinion. That is, prior to transferring this case to me upon his retirement, Special Master Abell held an evidentiary hearing for the s ole purpose of determining

the “onset” of J.H.’ s condition. In reaching his determination, Special Master Abell considered the weight to be afforded to the contemporaneous medical records, as well as the extent to which

the c ontradictory testimony of J.H.’ s parents shou ld be credited. (Abell Tr. 4

- 6 5 .) Special

Mas ter Abell noted the Petitioners’ burden to establish the facts by a preponderance of the evidence ( i.e. , more likely than not). (Abell Tr. 3.) Al though he deter mined that J.H.’s parents

were “ in general, credible people, very concerned , very moral” (Abell Tr. 10), he ultimately

determined that the medical records were entitled to greater weight in those areas in which the parents’ memories differed from the conte mporaneous medical records (Abell Tr. 17).

As Special Master Abell e xplained, at J.H.’ s six month visit with Dr. Peera in July of 2004, it was noted that she “rolls over in both directions, according to the parents, reaches for objects, transfers objects from one hand to the other, vocalizes, babbles, is more verbal than her brother, according to the parents, and she eats various things, soups, veggies, fruits, etc. In other words, to all intrinsic purposes, she appears normal for her age in time. ” (Abe ll Tr. 7.) At J.H.’ s nine

- month visit on October 14, 2004, howe ver, it was noted that she was “ not rolling over, not sitting alone,” so that “ she has lost * * * an ability that she had.” ( Id . at 8.) It was also noted at

the October visit that J.H. had s lightly decreased muscle tone in her lower extremities. ( Id . at 7

- 8.) Thus, Special Master Abell concluded, the medical records of July and October of 2004

indicate that J.H. had already begun experiencing a loss of skil ls prior to receiving her first f lu vaccination on October 14, 2004. (Id. at 8.)

5 As noted above, Special Master Abell held his evidentiary hearing, at which he heard

, in person, the testimony of Jessica’s parents

, on August 28, 2008, and the transcript of that hearing was filed into the record of this case on September 23, 2008 (ECF No. 37). Special Master Abell later g ave an oral ruling concerning the onset issue on January 14, 2010, which was transcribed. (Abell Tr., ECF No. 56

, filed on February 18, 2010.)

11In addition, Special Master Abell compared the parental testimony to the records containing ad ditional histories that J.H.’ s parents related when she visited specialist physicia ns during the following mont hs. He noted that those histories given by the parents, like the medical records of July and October 2004, also indicate that J.H.’ s neurological deterioration began well
prior to th e October 2004 flu vaccination. For example, Special Master Abell noted specif ically

that the records of J.H.’ s visit to the Mayo Clinic clearly point back to the period when she wa s six to eight months old

-- i.e.

, July to September of 2004

-- as the time when the first symptoms of her neurological demise began. (Abell Tr. 11

- 12 .) He further noted that in “ sever al” different medical histories, J.H.’ s parents noted that her developmental progress began to fall noticeably behind the progress of her twin brother at about age six months

-- again, in July of 2004. ( Id . at

11

- 12.) Special Master Abell noted that the medical records as a whole indicate that J.H.’ s d evelopmental and neurological progress stopped

-- that is, she leveled off or “plateaued”

-- about July of 2004. ( Id . at 12

- 13.) He added that the records in general in dicated a clear loss of skills between July and October of 2004. ( Id . at 13.) He found it “clear” that there was a “retrogression” in J.H.'s neurological development prior to t he vaccination of October 2004. ( Id

. at 15.)

In making these findings, Spec ial Master Abell, as noted above, stressed that he found J.H.’s parents “in general” to be “credible” and “moral” people. (Abell Tr. at 10.) He did not find that they were intentionally failing to tell the truth. But when he compared their testimony

to the clear statements in J.H.’ s medical records, he found that the medical records gave a more accurate history of J.H.’s neurological development and deterioration than did some of the

p are ntal testimony. (Id. at 12.) That special master found “clear di screpancies or

inconsistencies” between some of the parental memories and the medical records

, and to the

extent of those inconsistencies he found the medical records to be more believable. ( Id . at 17.)

I, too

, have read the testimony of J.H.’ s parents and compared them to the notations in the medical records. I concur with Special Master Ab ell's analysis in this regard. 6 I concur entirely with Special Master Abell's comparison of the records made in July and October of 2004, and his

firm conclusion fro m those two records.

Further, Dr. McGeady interpreted the medical records exactly as both Special Master Abell and I have. Comparing the records of July and October of 2004, Dr. McGeady, too, firmly concluded that J.H. was already exhibiting symptoms of her neurological demise prior to t he first

flu vaccination in October. (Ex. A, p. 4; 3

- Tr. 83

- 84.) Dr. McGeady also explained that in the medical records he saw no evidence of a sharp decline in J.H. ’ s neurological condition a fter

either the Oct ober or November vaccinations. (3

- Tr. 85

- 87.) 7

6 I note that after the case was transferred to me, the Petitioners did not request that I hear their testimony myself.

7 It is also noteworthy that when J.H. first saw a neurological specialist on December 20, 2004, and the neurologist recorded a history of her neurological problems, that neurologist did not mention either of the influenza vaccinations, or indica te either that J.H. had the onset of her neurological symptoms in October of 2004, or that her neurological symptoms worsened soon after her second flu shot in November of 2004. (Ex. 4, p. 371.) In fact, that history seems to indicate that the family fir st noticed the symptoms of J.H.’s neurological deterioration at age six

months , or in July of 2004, rather than in October of 2004 as Dr. Oleske assumed.

12In sum, because Dr. Oleske based his causation opinion on the clearly incorr ect assumption that J.H.’ s neurological demise began after the influenza vaccination of October 2004, Dr. Oleske's causati on opinion may be rejected for that reason alone

.

VIII

ADDITIONAL REASONS TO CREDIT DR. MCGEADY’S

TESTIMONY OVER THAT OF DR. OLESKE

As noted above, because Dr. Oleske based his testimony on a clearly flawed assumption

as to the time of onset of J.H.’ s neurological dysfunction, his causation opinion can be readily dismissed for that reason alone. But I will also briefly discuss several additional reasons to

discount Dr. Oleske's causation opinion.

A. Dr. McGeady’s testimony was more persuasive in general

.

In general, Dr. McGeady's presentation was substantially more persuasive than that of

Dr. Oleske. Dr. McGeady was better able to answer questions and defend his op inion. Dr. Oleske's opinion was plagued by gaps in logic

.

Most glaringly, Dr. Oleske simply failed to put forth any coherent presentation of evidence or reasoning to support his causation conclusion. As explained above, Dr. Oleske opined that J.H.’s neu rological degeneration was initially caused by her first influenza vaccination in October of 2004, and then exacerbated by her second influenza vaccination one month later. But Dr. Oleske simply failed to offer any coherent evidence for the proposition th at
an influenza vaccination is even capable of damaging a child’s brain so as to result in causing or exacerbating a neurological deterioration. Dr. Oleske failed to point to any medical articles or other actual evidence demonstrating that influenza inocul ations can injure the brain. He failed to persuasively explain by what mechanism influenza vaccinations might injure the brain.

And Dr. McGeady, on the other hand, was persuasive in pointing out the lack of any scientific support for Dr. Oleske's specula tions. He found that Dr. Oleske's theory of the case

was n ot persuasive, but instead was “most unlikely.” (Ex. A, p. 11.) Dr. McGeady found no

causal association at all between J.H.'s influenza vaccination s and her neurological disorder. (Ex. A, p. 12; 3

- Tr. 76

- 77, 93.) He explained that, unfortunately, for some neurological disorders, like that of J.H., no cause is ever identified. (3

- Tr. 102.) He opined that J.H.’ s neurological condition would have been the same had she never had the influenza vaccinations. (3

- Tr. 87.)

B. Dr. McGeady was persuasive in refuting Dr. Oleske’s speculation that a dysfunction of

J.H.’s immune system might have had a role in causing neurological degeneration

.

In theorizing as to how J.H.’ s i nfluenza vaccinations might have caused her neurological dysfunction, Dr. Oleske repeatedly pointed to p ossible immunological problems in J.H. In his

13first ex pert report, he pointed to the “ presence of abnormal immune stud ies” in J.H.’s records. (Ex. 1 5, p. 2.) He asserted that J.H. had “immune abnormalities” which “ could have been due to an unusual immunological response to the flu vaccine that has also caused her neurological

deterioration.” ( Id . at 3.) In his sec ond report, he stated that the “injur y” that J.H. “ suffered due

to the vaccine” could be due to “ an immune

- mediated toxic response.” (Ex. 17, p. 3.) During his hearing testimony, he again pointed to “abnormalities” in J.H.’s immune system. (3

- Tr. at 13.)

It is notable, however, that while in his second expert report Dr. Oleske theorized that

J.H. “ is the victim of a toxic

- autoimmune reaction” to her two flu vaccinations (Ex. 17, p. 5), at the hearing, he backed off from that position, conceding that there is insufficien t evidence of a "toxic" response and chara cterizing it instead as simply “an immune

- mediated response.” (3

- Tr. 17.)

Further, Dr. Oleske never explained why he thought that influenza vaccine might be capable of causing an unusual immunological response that could lead to the type of severe neurological demise such as the one that J.H. suffered. He never pointed to any medical literature supporting his reasoning on this point. His opinion seemed to amount to mere speculation, or guesswork. When pressed on cross

- examination, the best he co uld do was to suggest, without documentation, that “some” un specified vaccines can lead to “neuroimmune

reactions” (3

- Tr. at 58), app arently reasoning that because “some” vaccines can cause

“ neuroim mune reactions,” the i nfluenza vaccination is capable of causing the type of neurological degeneration from which J.H. suffered.

To the contrary, Dr. McGeady testified that he saw no merit in Dr. Oleske's speculation that an immune system response caused or cont ributed to J.H.'s neurological disorder.

First, Dr. McGeady explained that J.H.'s medical records do not support a conclusion that

J.H. even has immune dysfunction, from whatever source. (Ex. A, pp. 6

- 7; 3

- Tr. 77.)

Dr. McGeady noted that the existence of an abnormal number of lymphocytes in one 2008 test of

J.H. does not indicate that J.H. had any immune system abnormality in 2004

- 2005, when she suffered her fairly abrupt neurological demise. (Ex. A, pp. 6

- 7.) To the contrary, Dr. McGeady explained t hat the high lymphocyte count in 2008 could just mean that J.H. was experiencing an infection on that day in 2008. (Ex. A at 7.) He explained that the Mayo Clinic records do not

show that the Mayo Clinic concluded that J.H. had an immune dysfunction. (3

- Tr. 91, 94

- 95.)

F urther, Dr. McGeady added that after review of J.H.'s overall records, it does not appear that J.H. is unusually susceptible to infections, indicating that J.H. is not immunologically abnormal. (Ex. A at 7; 3

- Tr. 77, 96.)

In short, th ere is no significant evidence that J.H. even has an immune dysfunction. And even if she did, Dr. Oleske has provided no evidence for his speculations either (1) that the influenza vaccinations caused such immune dysfunction, or (2) that such immune dysfu nction

contributed to her neurological disorder. In sum, Dr. Oleske's speculation about a possible

14immune dysfunction in J.H. contributing to her neurological disorder is just that

-- nothing but mere speculation without any significant evidence behind it.

C. Petitioners’ “challenge

- rechallenge” theory is not persuasive

.

Petitioners’ post

- hearing briefs assert that J. H.’s case is an example of the “challenge/rechallenge” theory of causation, and that such challenge/rechallenge theory supports
a conclusio n that J.H.’ s neurological disorder was vaccine

- caused. I find no merit in this

argument.

It is noteworthy that Dr. Oleske’s first expert report did not even mention “challenge/rechallenge.” (Ex. 15.) His second expert report only briefly mentions that concept. (Ex. 17, pp. 2, 5.) During the evidentiary hearing, Dr. Oleske again only briefly mentioned the concept, in response to a question by petitioners’ counsel. (3

- Tr. 18.) Therefore, it is not even clear to what extent Dr. Oleske actually signifi cantly relied upon the “challenge/rechallenge” concept in developing his causation theory in J.H.’s case.

In any event, after closely studying the record of this case, I firmly conclude that the “challenge/rechallenge” concept does not apply to this case

.

To be sure, if a true instance of “challenge/rechallenge” occurs, that can indeed be powerful evidence of causa tion. As Dr. Oleske explained, “challenge/rechallenge” refers to a situation where a person has a reaction to one administration of a vaccine or drug, and then

“ suffers worsened symptoms after additional administratio n of that same vaccine or drug.” (Ex. 17, p. 5.) For example, in one Vaccine Act c ase , it was noted that the c hallenge/rechallenge theory could be successfully used to establish causation. Capizzano v. HHS

, 2004 WL 1399178 (Fed. Cl. Sp. Mstr. 2004), rev’d on other grounds 440 F.3d 1317 (Fed. Cir. 2006). In

that case, the special master stated that the “ challe nge/rechallenge cases are such s trong proof of causality that it is u nnecessary to determine the mechanism of cause

-- it [causation] is understood to be occurring.” 2004 WL 1399178 at *15

- 16.

Unfortunately for Petitioners, how ever, the actual facts of J.H.’ s case clearly do not fit the challenge/rechallenge scenario.

In this case, as explained above, and contrary to Dr. Oleske's assumption, J.H. clearly did not suffer the first symptoms of her neurological disorder after her first influenza vaccination in

October o f 2004 (see Section VII), nor did she suffer a second rapid onset of symptoms after her second influenza vaccination in November of 2004. To the contrary, as discussed above, the record of this case makes it clear that J.H., unfortunately, was already experiencing the initial symptoms of her neurological di sorder during the months prior to her first influenza examination. Further, as Dr. McGeady explained (3

- Tr. 85

- 87), the records do not in dicate any sharp change in J.H.’ s neurolog ical symptoms after either her October or Nove mber influenza

vaccinations. Of course, there is no doubt that J.H. ’ s disorder, which clearly was present prior to her October vaccination, did significantly worsen in late 2004 and early 2005. But the medical

15records made during that time period do not point to any rapid turn for t he worse in her symptoms after either of the vaccinations in question.

Accordingly, I do not find that J.H. ’s case fits the “challenge/rechallenge” scenario, as petitioners assert. The challenge/rechallenge argument is not persuasive in this case.

D. Summary concerning causation issue

In short, Dr. Oleske's assertion concerning immune de ficiency playing a role in J.H.’ s disorder, as we ll as his assertion concerning “challenge/rechallenge,” are both found to be without merit. I find his causation theories to be wholly unpersuasive, and I find the contrary testimony of Dr. McGeady to be persuasive.

IX

PETITIONERS’ CASE FAILS THE ALTHEN TEST

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

discussed the “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 provid ing: (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 the vaccinat ion 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 fa ctors unrelated to the vaccine.”

( Althen , 418 F.3d 1274, 1278 (Fed . Cir. 2005)(citations omitted).) In this part of my Decision, then, I will briefly explain how this case fits specifically withi n the three parts of the Althen test,
enumerated i n the first sentence of the Alt hen excerpt set forth above. The short answer is that I find 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 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 tha t the petitioners must provide “(1 ) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vac cination was the re ason for the injury.” Initially, it is not absolutely clear how the two prongs differ from each other. That is, on their face , each of the two prongs seems t o require a demonstration of a “causal”

connection between the “vaccination” a nd “the injury.” However, a number of Program opinions have concluded that these first two elements reflect the analytical distinction that has

16been described as the “can cause” vs. “did cause” distinction. That is, in many Program opinions issued prior t o 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 vaccine e 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, 200 2).) 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 interpretati on 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 firs t 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 th at 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 petition er 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 “prepon derance of the evidence.” (§ 300aa

- 13(a)(l )(A).) And, whatever is the precise meaning of Prongs 1 and 2 of Althen , in this case the overall evidence

falls far sho rt of demonstrating that it is “more probable than not” that the influenza vaccines that

J.H. received contributed to the causation of her tragic neurodevelopmental disorder.

B. Petitioners may reach the Althen analysis despite the lack of a specific diagnosis

in this case.

Bef ore addressing the individual Al then prongs in this case, I note that Respondent argued that as a threshold matter, without even reaching the Althen test, I must reject Petitioners’

c laim for a failure to identify “ at least one defined and recogniz ed injury.” (ECF No. 112, p. 12.)

For the reasons discussed below, I disagree.

To be sure, as Respondent points out, the Federal Circuit has held that “ if the existence and nature of the injury itself is in dispute, it is the special master's duty to first determine which
injury was best support ed by the evidence presented in the record before applying the Althen test
to dete rmine causation of that injury.” Lombardi v. HHS , 656 F.3d 1343, 1352 (Fed. Cir. 2011), (citing Broekelschen v. HHS , 618 F.3d 1339, 1349 (Fed. Cir. 2010)) (emphasis added). The

Federal Circui t has also held, however, that “the special masters are not ‘diagnosing’ vaccine

related injuries. The sole issues for the special master are, based on the record evidence as a whole and the totality of the case, whether it has been sh own by a preponderance of the evidence that a vaccine caused the child’s injury or that the child’ s injury is a table injury, and whether it

17has not been shown by a preponderance of the evidence that a factor unrelated to the vaccine caused the child’s inj ury.” Knudsen v. HHS , 35 F.3d 543, 549 (Fed. Cir. 1994); see also

Lombardi , 656 F.3d at 1351.

In Lombardi , the petitioner alleged that she suffered three different conditions. Respondent disputed all three potential diagnoses and advanced five additional possible

conditions. Lombardi , 565 F.3d at 1353

- 54. In Broekelschen

, the petitioner received a differential diagnosis from his treating physicians, and the petitioner claimed to be suffering

from one of th e identified conditions while respondent claimed t hat the other identified condition

w as present. Broekelschen , 618 F.3d at 1342

- 43. In both cases, the decision ultimately turned on

which injury among competing suggestions was actually suffered. Thus, the Federal Circuit indicated that the special maste rs were correct to consider the reliability of the p etitioner's diagnosis before exploring causation under Althen

. Broekelschen , 618 F.3d at 1346; Lombardi

, 565 F.3d at 1352. Put another way, these decisions indicate that where the respondent presents

ev idence of an alternate diagnosis, the special mas ter may consider the respondent’ s evidence of

that alternative diagnosis as part of the master’ s evaluation of the petitioner's prima facie showing of an injury, potentially mooting the Althen causation tes t. ( See, e.g., Broekelschen

, 618 F.3d at 1350 (holding that “ the special master pro perly considered the government’s alternative evidence on injury prior to determining causation”). However, this is not the same as putting an affirmative burden on the pe titioner to come forward with a specific diagnosis, as Respondent

argues. See, e.g.

, Kelley v. HHS , 68 Fed. Cl. 84, 100 (Fed. Cl. 2005)("The Vaccine Act does not require petitioners coming under the non

- Table injury provision to categorize their injury; th ey are merely required to show that the vaccine in question caused them injury

-- regard less of the ultimate diagnosis.” ).

In any event, the present case does not present conflicting diagnoses, in contrast to both

Lombardi and Broekelschen . Rath er, in this case none of J.H. 's treating physicians has come forward with a specific diagnosis, and both Petitioners’ and Respondent's experts agree that there

is no availa ble specific diagnosis for J.H.’ s tragic neurological disorder. (See, Ex. 15, p. 2, noting the lack of a d efinitive diagnosis in J.H.’s medical records and cha racterizing the condition as a “unique syndrome” .) Yet, despite the lack of a precise diagnosis, both experts agree as a basic proposition that the injury from which J.H. suffers is a ne urological degeneration . (3

- Tr. 5

- 6; 115

- 16.) The question in this case, then, is not the formal name of the neurological condition that J.H. suffered, but whether J.H. ’ s influenza vaccinations caused her neurological degeneration, as Petitioners allege, or wheth er the cause of J.H.’ s condition remains a mystery, as Respondent contends. In this regard, Respondent does not offer any alternative diagnosis, bu t simply challenges Petitioners’ theory as to whether J.H.’ s influenza vaccinations

can cause or di d cause her condition.

Thus, while no diagnosis precisely naming J.H.’ s neurological disorder exists, I do not find that there is any reason to preemptively decide this case, as Respondent suggests, without considering the Althen test. Rather than rais ing an alternate diagnosis, Respondent raises precisely the issues to be decided under Althen

.

18C. Petitioners have failed to establish Prong 1 of Althen in this case.

Turning, then, to the Althen analysis, under Prong 1 of Althen a petitioner must, as described above, 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 wholly failed

to show that influenza vaccinations of any kind can cause the type of injury from which J.H.

suffers.

Here, as described in Sections VIII(B) and (C) abov e, Petitioners seem to rely on “immune dysfunction” and “challenge

- rechallenge” theories to establish that influenza vaccinations are cap able of causing a neurological condition lik e that from which J.H. suffers. For the reasons described in Sections VIIl(B) and (C), however, Petitioners’ reliance on those theories was clearly insufficient to meet petitioners ’ burden of demonstrating a pla usible medical theory. Therefore, Petitioners plainly have failed to establish Prong 1 of Althen in this case.

D. Petitioners have failed to establish Prong 2 of Althen

.

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

that J.H.’ s vaccinations did cause her own severe neurodevelopmental disorder

-- i.e. , to show “ a logical sequence of cause and effect showing that the vaccination wa s the reason for the injury.”

Althe n , 418 F.3d at 1278 . H owever, Petitioners have completely failed to make such a showing.

That is, for the reasons described in detail above, I find that the Petitioners have failed to

e st ablish that the onset of J.H.’ s condition took place after her first influenza vaccination; that she suffered rapid neurological downturns after either of her influenza vacci nations; that she suffers from “immune dysfunction;” or that her case fits a “challenge/rechallenge” scenario. Therefore, I find that Petitio ners plainly have failed to meet their burden under the se c ond Althen

prong. 8

E. Petitioners have failed to establish Prong 3 of Althen

.

Finally, under Althen Pro ng 3, a petitioner must demonstrate “ a proximate temporal relationship betw een the vaccina tion and injury.” Althen , 418 F.3d at 1278. The Federal Circuit

has further clarified that Althen Prong 3 requires “ preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medica l understanding of the disorder’ s

e tiology, it is medically accepta ble to infer causation

- in fact.” D eBazan v. HHS

, 539 F.3d 1347, 1352 (Fed. Cir. 2008).

8 Citing to Knudsen v. HHS , 35 F.3d 543 (Fed. Cir. 1994), Petitioners stress that they are not require d to prove “the mechanism of injury,” and note that “the determination of causation under the Vaccine Act involves ascertaining whether the sequence of cause and effect is ‘logical’ and legally probable, not medically or scientifically certain.” (ECF 109, p. 18.) Petitioners are correct in these assertions, but I have not required them to demonstrate a “mechanism” of injury, or to prove causation to a scientific certainty. Rather, Petitioners have fallen far short of showing that it is “more probable than not” that vaccinations played any role in causing or exacerbating J .H.’s tragic

disorder.

19Since I have found that Petitioners have failed meet their burden on the first two Althen prongs, I need not reach the question of whe ther they have failed to meet their burden under the third prong. But in the interest of completeness, I also find that Petitioners have failed to establish Prong 3. For the reasons explained at Section VII above, I find that Petitioners' expert

relied upon a flawed assumption of fact concerning the onset of J.H. ’ s neurological condition.
Moreover, since Dr. Oleske was totally unpersuasive in arguing that there is any reason to think

that influenza vaccinations even can cause the type of neurological degeneration that J.H.

suffered

, so also he failed to offer any persuasive evidence as to when the first symptoms of such

an influenza vaccine

- caused disorder might appear.

F. This is not a close case.

As noted above, in Althen the Federal Circuit indi cated t hat 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 h ere that this case ultimately is not

a close case. For al l the reasons set forth above, I find that Petitioners have failed to meet any of

the Althen prongs. They have not only failed to come forward with a plausible medical theory, but have also failed to find adequate support in the record for the theories th at they did advance. This is simply not a close case at all.

IX

CONCLUSION

The record of this case demonstrates plainly that J.H. and her 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 injuries or de aths 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 Petitioners in this case are not enti tled to a Program award. 9

IT IS SO ORDERED

.

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

9 In the absence of a timely

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

20