VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_06-vv-00371
Package ID: USCOURTS-cofc-1_06-vv-00371
Petitioner: J.H.
Filed: 2006-05-08
Decided: 2014-08-26
Vaccine: influenza (two half-doses, pediatric formulation)
Vaccination date: 2004-10-14
Condition: neurological degeneration, loss of motor skills and body control
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On May 8, 2006, Francia and Peter Hirmiz filed a petition for compensation under the National Childhood Vaccine Injury Act on behalf of their daughter, J.H., alleging that two half-doses of influenza vaccine administered on October 14 and November 16, 2004, caused her neurological degeneration. J.H. was born on January 12, 2004. Initially, she developed normally, meeting milestones at her six-month check-up on July 16, 2004. However, by her nine-month visit on October 14, 2004, she had lost skills, including the ability to roll over and sit alone, and exhibited decreased muscle tone. She received the first half-dose of the influenza vaccine on this date. A second half-dose was administered on November 16, 2004, after which she was referred to a neurologist. By January 18, 2005, her 12-month visit, she had further lost motor skills and experienced weight percentile collapse. Extensive evaluations by multiple specialists at various institutions, including the Mayo Clinic, did not yield a definitive diagnosis for her condition, which was described over time as spastic diplegia, cerebral palsy, and spastic quadriplegia with global developmental delays. Petitioners amended their petition to focus solely on the influenza vaccines, alleging a "challenge-rechallenge" pattern and immune dysfunction as the causation theory, supported by their expert, Dr. James M. Oleske. Respondent's expert, Dr. Stephen J. McGeady, contended that J.H.'s neurological deterioration began before the first influenza vaccination, between July and October 2004, based on the loss of skills documented between the July and October pediatric visits. Dr. McGeady also disputed the challenge-rechallenge theory and immune dysfunction claims, stating that the medical literature did not support influenza vaccine causing such severe neurological degeneration and that J.H.'s lymphocyte abnormality likely reflected a coincident infection. Special Master Abell, in a prior onset hearing, found that J.H.'s symptoms began between July 16 and October 14, 2004, prior to the first influenza vaccination, giving precedence to contemporaneous medical records over parental testimony where discrepancies existed. Special Master George L. Hastings, Jr., subsequently denied entitlement, finding Dr. Oleske unpersuasive because his opinion was based on a flawed premise of post-vaccination onset, and that the challenge-rechallenge and immune dysfunction theories were unsupported. He concluded that petitioners failed all three prongs of the Althen test for causation-in-fact: no medical theory showing influenza vaccine can cause this injury, no logical sequence of cause and effect, and no proximate temporal relationship due to pre-vaccination onset. The Court of Federal Claims, Judge Charles F. Lettow presiding, affirmed the denial, rejecting petitioners' theories and denying a motion to amend the petition to include a significant-aggravation claim. The Federal Circuit affirmed without opinion under Rule 36, and the Supreme Court denied certiorari. Special Master Hastings awarded $121,906 in fees and $991 in costs for the entitlement phase. Judge Lettow later awarded an additional $67,733.50 for the Federal Circuit appeal, reversing the denial of those fees, but affirmed the denial of fees for further appellate proceedings, resulting in a total award of $190,630.50.

Theory of causation field:
Petitioners alleged that two half-doses of influenza vaccine administered on October 14, 2004, and November 16, 2004, caused J.H.'s severe neurological degeneration through a "challenge-rechallenge" mechanism and immune dysfunction, supported by expert Dr. James M. Oleske. Respondent's expert, Dr. Stephen J. McGeady, argued that J.H.'s symptoms began prior to the first vaccination between July and October 2004, and that the vaccine could not cause such an injury. Special Master George L. Hastings, Jr. denied entitlement, finding that J.H.'s condition predated the vaccinations, thus failing the "proximate temporal relationship" prong of the Althen test, and that the medical theories presented were unpersuasive. The Court of Federal Claims affirmed, and the Federal Circuit and Supreme Court denied further review. Attorneys' fees were awarded for the entitlement phase and the Federal Circuit appeal, totaling $190,630.50.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_06-vv-00371-0
Date issued/filed: 2014-09-17
Pages: 20
Docket text: PUBLIC DECISION (Originally filed: 08/26/2014) regarding 119 DECISION of Special Master Signed by Special Master George L. Hastings. (dlb) Copy to parties.
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Case 1:06-vv-00371-CFL Document 120 Filed 09/17/14 Page 1 of 20
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 06-371V
Filed: August 26, 2014
(To be published1)
* * * * * * * * * * * * * * * * * * * * * * * * *
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.
Petitioners, *
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES *
*
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
John F. McHugh, New York, NY, for Petitioners.
Linda Renzi, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION
HASTINGS, Special Master.
This is an action in which the Petitioners, 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 petitioners 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-10 et seq. (2006).
Hereinafter, for ease of citation, all “§” references will be to 42 U.S.C. (2006).
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Case 1:06-vv-00371-CFL Document 120 Filed 09/17/14 Page 2 of 20
two half-dose influenza vaccines administered on October 14 and November 16, 2004. For the
reasons set forth below, I conclude that Petitioners 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 the 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 between the vaccination and the injury. In some cases, the petitioner
may simply demonstrate the occurrence of what has been called a “Table Injury.” That is, it may
be shown that the vaccine recipient suffered an injury of the type enumerated in the “Vaccine
Injury Table” corresponding to the vaccination in question, within an applicable time period
following the vaccination also specified in the Table. If so, the Table Injury is presumed to have
been caused by the vaccination, and the petitioner is automatically entitled to compensation,
unless it is affirmatively shown that the injury was caused by some factor other than the
vaccination. (§300aa-13(a)(1)(A); §300aa-11(c)(1)(C)(i); §300aa-14(a); §300aa-13(a)(1)(B).)
In other cases, however, the vaccine recipient may have suffered an injury not of the type
covered in the Vaccine Injury Table. In such instances, an alternative means exists to
demonstrate entitlement to a Program award. That is, the petitioner may gain an award by
showing that the recipient’s injury was “caused-in-fact” by the vaccination in question. (§300aa-
13(a)(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 petitioner to introduce
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 “preponderance 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 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 form of scientific studies or expert medical testimony.” (Althen, 418 F.3d at
1278; Grant v. HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992).)
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Case 1:06-vv-00371-CFL Document 120 Filed 09/17/14 Page 3 of 20
The Althen court also provided additional discussion of the “causation-in-fact” standard,
as follows:
Concisely stated, Althen's burden is to show by preponderant evidence that the
vaccination brought about her injury by providing: (1) a medical theory causally
connecting the vaccination and the injury; (2) a logical sequence of cause and
effect showing that the vaccination was the reason for the injury; and (3) a
showing of 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 the injury was in fact caused by
factors unrelated to the vaccine.”
(Althen, 418 F.3d at 1278 (citations omitted).) The Althen court noted that a petitioner need not
necessarily supply evidence from medical literature supporting petitioner's causation contention,
so long as the petitioner supplies the medical opinion of an expert. (Id. at 1279-80.) The court
also indicated that, in finding causation, a Program 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 claimants.” (Id. at 1280.)
Since Althen, the Federal Circuit has addressed the causation-in-fact standard in several
additional rulings, which have affirmed the applicability of the Althen test, and afforded further
instruction for resolving causation-in-fact issues. In Capizzano v. HHS, 440 F.3d 1317, 1326
(Fed. Cir. 2006), the court cautioned Program fact-finders against narrowly construing the
second element of the Althen test, confirming that circumstantial evidence and medical opinion,
sometimes in the form of notations of treating physicians in the vaccinee’s medical records, may
in a particular case be sufficient to satisfy that second element of the Althen test. Both Pafford v.
HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006), and Walther v. HHS, 485 F.3d 1146, 1150 (Fed. Cir.
2007), discussed the issue of which party bears the burden of ruling out potential non-vaccine
causes. DeBazan v. HHS, 539 F.3d 1347 (Fed. Cir. 2008), concerned an issue of what evidence
the special master may consider in deciding the initial question of whether the petitioner has met
her causation burden. The issue of the temporal relationship between vaccination and the onset
of an alleged injury was further discussed in Locane v. HHS, 685 F.3d 1375 (Fed. Cir. 2012), and
W C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013). Moberly v. HHS, 592 F.3d 1315 (Fed. Cir. 2010),
concluded that the “preponderance of the evidence” standard that applies to Vaccine Act cases is
the same as the standard used in traditional tort cases, so that conclusive proof involving medical
literature or epidemiology is not needed, but demonstration of causation must be more than
“plausible” or “possible.” Both Andreu v. HHS, 569 F.3d 1367 (Fed. Cir. 2009), and Porter v.
HHS, 663 F.3d 1242 (Fed. Cir. 2011), considered when a determination concerning an expert's
credibility may reasonably affect the outcome of a causation inquiry. Broekelschen v. HHS, 618
F.3d 1339 (Fed. Cir. 2010), found that it was appropriate for a special master to determine the
reliability of a diagnosis before analyzing the likelihood of vaccine causation. Lombardi v. HHS,
656 F.3d 1343 (Fed. Cir. 2011), and Hibbard v. HHS, 698 F.3d 1355 (Fed. Cir. 2012), both again
explored the importance of assessing the accuracy of the diagnosis that supports a claimant's
theory of causation. Doe 11 v. HHS, 601 F.3d 1349 (Fed. Cir. 2010) and Deribeaux v.
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Case 1:06-vv-00371-CFL Document 120 Filed 09/17/14 Page 4 of 20
HHS, 717 F.3d 1363 (Fed. Cir. 2013), both discuss the burden of proof necessary to establish
that a “factor unrelated” to a vaccine may have caused the alleged injury.
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.
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 amended. The original petition alleged that a
series of vaccinations administered in 2004 caused J.H. to experience "a degeneration of her
motor skills and body control noticeable after mid-October 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 normally for about eight months,” to allege that she “progressed
normally for about over ten months, i.e. at least until October 14, 2004." (Pet. at 1; Am. Pet. at
2.) In addition, the amended petition alleged that J.H. 's failure to progress resulted from the
half-dose influenza vaccines that she received on October 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
issued a bench ruling on January 14, 2010, finding that the onset of J.H.'s symptoms occurred
between July 16 and October 14, 2004, prior to the receipt of her half-dose flu vaccine
administered on October 14. (See Transcript of Proceedings (ECF No. 56) (“Abell Tr.”),
January 14, 2010; see also Findings 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 half-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.)
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Subsequently, on January 9, 2012, Petitioners filed an expert report by James Oleske,
M.D., accompanied by Dr. Oleske’s curriculum vitae. (Exs. 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 was filed on
September 10, 2012. (Ex. 17.) On December 5, 2012, I conducted an evidentiary hearing in
New York, New York, to receive testimony from the experts in this case. (See Transcript of
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 post-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 reply 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 various 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 rolling 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 rolling over, and not sitting alone.
(Id.) That 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 half-dose of the influenza virus vaccine at
that time. (Id.)
Approximately one month later, on November 16, 2004, J.H. received a second half-dose
of the influenza vaccine (Ex. 4, p. 10(a); Ex. 10, p. 10), and was referred to a neurologist.
J.H.'s initial 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 copies 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.
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appropriate, but diagnosed her with spastic diplegia and cerebral palsy. (Id.) Dr. Stumpf opined
that J.H.’s cerebral palsy stemmed from “twinning.” (Id.)
On January 18, 2005, J.H. had her 12-month well-child pediatric visit. (Ex. 10, p. 9.) The
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 single words, drink from a cup
with help, and feed herself some solids. (Id.) The doctor's assessment was “well developed but
with muscle weakness, motor delay.” (Id.) The doctor’s plan for J.H. was to follow up with
neurology. (Id.)
In early 2005, J.H. was also 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 neurologically over the ensuing year, and she was evaluated
and treated extensively by numerous physicians, including neurologists, geneticists,
pediatricians, orthopedic surgeons, and physical and rehabilitation specialists at Children’s
Memorial Hospital. (See generally Ex. 6.)
In late March 2005, J.H.’s parents and her physical therapist noted a loss of milestones,
difficulty feeding, and 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 maturation 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 degenerative disorder. (Id.)
In May 2005, swallowing function studies and MRIs with contrast of the brain and
cervical cord were administered and deemed normal. (Ex. 4, pp. 318, 347-48.) In June 2005,
J.H. also had a normal EEG. (Ex. 4, p. 318.) By June 2005, J.H. had deteriorated to the extent
that, as noted 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 unclear.” (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, but he also offered no diagnosis. (Ex. 8, p. 737.)
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The 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, Petitioners 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 Petitioners have failed to demonstrate
causation.
Petitioners’ theory of the case, while never very coherently organized by their expert,
Dr. Oleske, may be briefly summarized as follows. Petitioners contend that the onset of J.H.’s
condition occurred in 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 provokes the same
response on two independent occasions. Petitioners allege, particularly in the absence of any
other known etiology explaining J.H.’s condition, that “challenge-rechallenge” is proof of
causation. Petitioners also seem to 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 vaccination of October 14,
2004. Respondent’s expert also disputed the Petitioners’ “challenge-rechallenge” theory, as well
as various aspects of Dr. Oleske’s causation presentation. Respondent argues that Petitioners
have not demonstrated a causal link between J.H.’s condition and her flu vaccinations.
After carefully considering all of the evidence in the record, 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 failed to demonstrate that it is “more probable than not” that this pair of
vaccinations contributed 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 and hearing testimony of one medical
expert. At this point, I will briefly summarize both the credentials and the opinions of these
expert witnesses.
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A. Petitioners’ 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 Master’s of Public Health
degree from 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 and Dentistry of New Jersey,
Department of Pediatrics. (Id.) He interned and served as a resident at the College of Medicine
and Dentistry of New Jersey, Department of Pediatrics, from 1971-1973. (Id.) His research
fellowship took place at Emory University from 1974-1976. (Ex. 16, p. 1; 3-Tr. 4.) He
thereafter served at Emory as a clinical instructor 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
Jersey 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 Medical 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 Medicine and Dentistry of New Jersey. (Ex. 16, p, 3.) He also
currently works as a consultant at the Allergy and Immunology & Infectious Diseases Matheny
School and Hospital in Peapack, New Jersey. (Id.) Dr. Oleske’s resume lists 212 peer-reviewed
publications. (Id., pp. 19-33.)
2. Summary of opinion of Petitioners’ expert
Dr. Oleske stated in his first 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
temporally related to the onset of J.H.'s sudden and progressive neurological condition. (Ex. 17,
pp. 1-2; 3-Tr. 5.)
Dr. Oleske’s testified that the basis for his conclusion was “a clear onset of real
neurological 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] was in the
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Case 1:06-vv-00371-CFL Document 120 Filed 09/17/14 Page 9 of 20
normal 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 studies 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 deterioration. (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 episode 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
Science Degree in Biology in 1963. (Ex. B, p. 1; 3-Tr. 73-74.) He attended Creighton
University where he graduated in 1967 with a degree in medicine. (Ex. B, p. 1; 3-Tr. 74.)
Dr. McGeady served as a rotating intern at the St. Vincent's Hospital in New York from
1967-1968. (Ex. B, p. 1; 3-Tr. 74.) He served as a resident in Pediatrics at the St. Christopher's
Hospital in Philadelphia from 1970-1972. (Id.) He served as a fellow at Duke University in the
Psychiatry and Allergy unit from 1972-1974. (Ex. B, p. 1.) He has been appointed Director of
Pediatric Services at the Children’s Heart Hospital in Philadelphia, Medical Director at the
Children’s Heart Hospital, Medical Director of the Children’s Rehabilitation Hospital in
Philadelphia, and Medical Director of 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 Diagnostic and Laboratory Immunology. (Ex. B,
p. 11; 3-Tr. 74.) He is licensed in Pennsylvania, Delaware, and New Jersey. (Ex. B, p. 1.)
Dr. McGeady’s resume lists 54 peer reviewed articles. (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 deterioration, 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
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testified that she received routine immunizations 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 vaccinations in question. (Ex. A, p. 4.) While J.H.’s ability 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 were noted to be missing (Ex. 10, p. 5),
indicating a loss of skills (Ex. A, p. 4). Dr. McGeady also pointed to the notation of decreased
muscle tone in the lower extremities in the October 14, 2004 note, and the fact that a referral for
occupational/physical therapy was to be considered at the next visit. (Ex. A, p. 4.) Dr. McGeady
noted that for 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
skills in that time period would be alarming. (Ex. A, p. 4; 3-Tr. 83-84.) And since the first
influenza immunization 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
extension of a neurodegenerative process already in motion prior to October 14. (Ex. A, p. 5.)
Dr. McGeady also persuasively 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 case, I have found that Dr. Oleske’s view of the case
was quite unpersuasive, while Dr. McGeady’s opinion was far more persuasive. There are
several reasons for this conclusion.
First and foremost, Dr. Oleske based his opinion on a plainly flawed assumption as to the
time of onset of J.H.'s neurological symptoms. Dr. Oleske concluded that J.H.’s symptoms
began shortly after her flu vaccination of October 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 additional 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 neurologic 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 testimony 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.
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VII
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 glaring deficiency in Dr. Oleske’s causation opinion in
this case is that Dr. Oleske based his opinion on a plainly flawed assumption 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 after her vaccination
of November 16, 2004. However, J.H.’s medical records show quite clearly that, as
Dr. McGeady concluded, J.H.’s symptoms 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 onset 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 sole 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 contradictory testimony of J.H.’s parents should be credited. (Abell Tr. 4-65.) Special
Master Abell noted the Petitioners’ burden to establish the facts by a preponderance of the
evidence (i.e., more likely than not). (Abell Tr. 3.) Although he determined 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 contemporaneous medical records (Abell Tr. 17).
As Special Master Abell explained, 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.” (Abell Tr. 7.) At J.H.’s
nine-month visit on October 14, 2004, however, 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 slightly 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 skills prior to receiving her first flu
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 gave an oral ruling concerning the onset issue on
January 14, 2010, which was transcribed. (Abell Tr., ECF No. 56, filed on February 18, 2010.)
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In addition, Special Master Abell compared the parental testimony to the records
containing additional histories that J.H.’s parents related when she visited specialist physicians
during the following months. 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 the October 2004 flu vaccination. For example, Special Master Abell noted specifically
that the records of J.H.’s visit to the Mayo Clinic clearly point back to the period when she was
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 “several” 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
developmental 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 indicated 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 the vaccination of October 2004. (Id.
at 15.)
In making these findings, Special 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
parental testimony. (Id. at 12.) That special master found “clear discrepancies 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 Abell'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 from 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 the 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 after
either the October 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 indicate 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 first 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.
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In sum, because Dr. Oleske based his causation opinion on the clearly incorrect
assumption that J.H.’s neurological demise began after the influenza vaccination of October
2004, Dr. Oleske's causation 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 opinion.
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 neurological 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 that
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 inoculations 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 speculations. He found that Dr. Oleske's theory of the case
was not persuasive, but instead was “most unlikely.” (Ex. A, p. 11.) Dr. McGeady found no
causal association at all between J.H.'s influenza vaccinations 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 influenza vaccinations might have caused her neurological
dysfunction, Dr. Oleske repeatedly pointed to possible immunological problems in J.H. In his
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first expert report, he pointed to the “presence of abnormal immune studies” in J.H.’s records.
(Ex. 15, 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 second report, he stated that the “injury” 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 insufficient evidence of a
"toxic" response and characterizing 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 could do was to
suggest, without documentation, that “some” unspecified vaccines can lead to “neuroimmune
reactions” (3-Tr. at 58), apparently reasoning that because “some” vaccines can cause
“neuroimmune reactions,” the influenza 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 contributed 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 that 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.)
Further, 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, there 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 dysfunction
contributed to her neurological disorder. In sum, Dr. Oleske's speculation about a possible
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immune 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 conclusion 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 significantly 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 causation. 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 administration of that same vaccine or drug.” (Ex.
17, p. 5.) For example, in one Vaccine Act case, it was noted that the challenge/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 “challenge/rechallenge cases are such strong proof of
causality that it is unnecessary to determine the mechanism of cause -- it [causation] is
understood to be occurring.” 2004 WL 1399178 at *15-16.
Unfortunately for Petitioners, however, 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 of 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 disorder during the months prior to her first influenza
examination. Further, as Dr. McGeady explained (3-Tr. 85-87), the records do not indicate any
sharp change in J.H.’s neurological symptoms after either her October or November 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
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records made during that time period do not point to any rapid turn for the 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 deficiency playing a role in J.H.’s
disorder, as well 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. Court 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 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 the vaccination and injury.
If Althen satisfies this burden, she is “entitled to recover unless the [government]
shows, also by a preponderance of the evidence, that the injury was in fact caused
by factors unrelated to the vaccine.”
(Althen, 418 F.3d 1274, 1278 (Fed. Cir. 2005)(citations omitted).) In this part of my Decision,
then, I will briefly explain how this case 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
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 that 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 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 face, each of the two prongs seems to require a demonstration of a “causal”
connection between the “vaccination” and “the injury.” However, a number of Program
opinions have concluded that these first two elements reflect the analytical distinction that has
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been described as the “can cause” vs. “did cause” distinction. That is, in many Program opinions
issued prior to Althen involving “causation-in-fact” issues, special masters or judges stated that
a petitioner must demonstrate (1) that the type of vaccination in question can cause the type of
injury in question, and also (2) that the particular vaccination received by the specific vaccinee
did cause the vaccinee's own injury. (See, e.g., Kuperus v. HHS, 2003 WL 22912885, at *8 (Fed.
Cl. Spec. Mstr. Oct. 23, 2003); Helms v. HHS, 2002 WL 31441212, at *18 n. 42 (Fed. Cl. Spec.
Mstr. Aug. 8, 2002).) Thus, a number of judges and special masters of this court have concluded
that Prong 1 of Althen is the “can cause” requirement, and Prong 2 of Althen is the “did cause”
requirement. (See, e.g., Doe 11 v. HHS, 83 Fed. Cl. 157, 172-73 (2008); Nussman v. HHS, 83
Fed. Cl. 111, 117 (2008); Banks v. HHS, 2007 WL 2296047, at *24 (Fed. Cl. Spec. Mstr. July
20, 2007); Zeller v. HHS, 2008 WL 3845155, at *25 (Fed. Cl. Spec. Mstr. July 30, 2008).) And,
most importantly, the Federal Circuit confirmed that interpretation in Pafford, ruling explicitly
that the “can it?/did it?” test, used by the special master in that case, was equivalent to the first
two prongs of the Althen test. (Pafford v. HHS, 451 F.3d at 1352, 1355-56 (Fed. Cir. 2006).)
Thus, interpreting the first two prongs of Althen as specified in Pafford, under Prong 1 of Althen
a petitioner must demonstrate that the type of vaccination in question can cause the type of
condition in question; and under Prong 2 of Althen that petitioner must then demonstrate that the
particular vaccination did cause the particular condition of the vaccinee in question.
Moreover, there can be no doubt whatsoever that the Althen test ultimately requires that,
as an overall matter, a petitioner must demonstrate that it is “more probable than not” that the
particular vaccine was a substantial contributing factor in causing the particular injury in
question. That is clear from the statute itself, which states that the elements of a petitioner's case
must be established by a “preponderance of the evidence.” (§ 300aa-13(a)(l)(A).) And,
whatever is the precise meaning of Prongs 1 and 2 of Althen, in this case the overall evidence
falls far short of demonstrating that it is “more probable than not” that 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.
Before addressing the individual Althen prongs in this case, I note that Respondent
argued that as a threshold matter, without even reaching the Althen test, I must reject Petitioners’
claim for a failure to identify “at least one defined and recognized 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 supported by the evidence presented in the record before applying the Althen test
to determine 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 Circuit 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 shown 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
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has not been shown by a preponderance of the evidence that a factor unrelated to the vaccine
caused the child’s injury.” 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 the identified conditions while respondent claimed that the other identified condition
was 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 masters were correct to consider the reliability of the petitioner'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
evidence of an alternate diagnosis, the special master 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 test. (See, e.g., Broekelschen, 618
F.3d at 1350 (holding that “the special master properly 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 petitioner 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; they
are merely required to show that the vaccine in question caused them injury--regardless of the
ultimate diagnosis.”).
In any event, the present case does not present conflicting diagnoses, in contrast to both
Lombardi and Broekelschen. Rather, 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 available specific diagnosis for J.H.’s tragic neurological disorder. (See, Ex. 15, p. 2,
noting the lack of a definitive diagnosis in J.H.’s medical records and characterizing 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 neurological
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 whether the cause of J.H.’s condition remains
a mystery, as Respondent contends. In this regard, Respondent does not offer any alternative
diagnosis, but simply challenges Petitioners’ theory as to whether J.H.’s influenza vaccinations
can cause or did 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 raising an alternate diagnosis, Respondent raises
precisely the issues to be decided under Althen.
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C. 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) above, Petitioners seem to rely on
“immune dysfunction” and “challenge-rechallenge” theories to establish that influenza
vaccinations are capable of causing a neurological condition like 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 plausible 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 was the reason for the injury.”
Althen, 418 F.3d at 1278. However, 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
establish 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 vaccinations; that she
suffers from “immune dysfunction;” or that her case fits a “challenge/rechallenge” scenario.
Therefore, I find that Petitioners plainly have failed to meet their burden under the second Althen
prong.8
E. Petitioners have failed to establish Prong 3 of Althen.
Finally, under Althen Prong 3, a petitioner must demonstrate “a proximate temporal
relationship between the vaccination 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 medical understanding of the disorder’s
etiology, it is medically acceptable to infer causation-in fact.” DeBazan 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 required 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.
19

Case 1:06-vv-00371-CFL Document 120 Filed 09/17/14 Page 20 of 20
Since I have found that Petitioners have failed meet their burden on the first two Althen
prongs, I need not reach the question of whether 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 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 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 that 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 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 Petitioners in this case are not entitled 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

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_06-vv-00371-1
Date issued/filed: 2014-12-19
Pages: 13
Docket text: JUDGE VACCINE REISSUED REPORTED OPINION re: 127 Order on Motion for Review, Judge Vaccine Reported Opinion. Signed by Judge Charles F. Lettow. (gk)
--------------------------------------------------------------------------------
Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 1 of 13
In the United States Court of Federal Claims
No. 06-371V
(Filed: December 4, 2014)
(Reissued: December 19, 2014)
************************************* )
) Vaccine case; administration of half-
FRANCIA HIRMIZ and PETER HIRMIZ, ) doses of influenza vaccine to a child;
as best friends of their daughter, J.H., ) causation related to neurological
) degeneration; pre-existing condition
Petitioners, )
)
v. )
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Defendant. )
)
*************************************
John F. McHugh, New York, NY, for petitioner.
Linda S. Renzi, Senior Trial Counsel, Torts Branch, Civil Division, United States
Department of Justice, Washington, D.C., for defendant. With her on the briefs were Joyce R.
Branda, Acting Assistant Attorney General, Civil Division, Rupa Bhattacharyya, Director, Torts
Branch, Civil Division, Vincent J. Matanoski, Deputy Director, Torts Branch, Civil Division,
and Gabrielle M. Fielding, Assistant Director, Torts Branch, Civil Division, United States
Department of Justice, Washington, D.C.
OPINION AND ORDER
LETTOW, Judge.
Petitioners, Francia and Peter Hirmiz, on behalf of their daughter, J.H., seek review of a
decision by a special master dated August 26, 2014, denying them an award under the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, § 311, 100 Stat. 3743, 3755 (1986)
(codified, as amended, at 42 U.S.C. §§ 300aa-1 to -34) (“Vaccine Act”). Petitioners allege that
the injection of their daughter with two half-doses of influenza vaccine, administered on October
14, 2004 and November 16, 2004, caused her subsequent severe neurological degeneration. The
Secretary of Health and Human Services (“the government”) acknowledges J.H.’s compromised
condition but argues that its cause is unrelated to inoculation of the vaccine.

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 2 of 13
J.H. to date has no confirmed diagnosis. Petitioners claim an off-Table vaccine injury for
which they must establish causation in fact by a preponderance of the evidence. See 42 U.S.C.
§§ 300aa-11(c)(1)(B), (C)(ii)(I); 300aa-13(a)(1); Althen v. Secretary of Health & Human Servs.,
418 F.3d 1274, 1278 (Fed. Cir. 2005). The special master, applying the test set forth in Althen,
denied relief on the ground that petitioners “failed to demonstrate that it is ‘more probable than
not’ that this pair of vaccinations contributed to causing their daughter’s condition.” Hirmiz v.
Secretary of Health & Human Servs., No. 06-371V, slip op. at 7 (Fed. Cl. Spec. Mstr. Aug. 26,
2014) (“Entitlement Decision”).1 The special master additionally noted that “it appears more
likely than not that J.H.’s condition predated these vaccinations.” Id. Petitioners challenge the
special master’s decision, maintaining that their theory of an autoimmune attack on the nervous
system triggered by the vaccinations is “plausible, probable[,] and entirely consistent with the
facts,” claiming that the special master “arbitrarily ignored the great weight of the evidence,” and
averring that his conclusion was “contrary to law.” Pet’rs’ Pet. for Review of the Decision of the
Office of Special Mstrs. dated Aug. 26, 2014 (“Pet’rs’ Mot.”) at 1, 16, 18, ECF No. 121.2 The
petitioners’ motion for review has been fully briefed and a hearing was held on November 13,
2014.
STATEMENT OF FACTS
J.H. and her twin brother were born on January 12, 2004. Entitlement Decision at 5.
During the first few months of her life, J.H.’s development appeared normal. Id. She had well-
child exams at the ages of sixteen days and six months and received vaccinations for DTaP, HIB,
Hep B, and Prevnar on March 15, May 17, and July 16, 2004. Id. No concerns or adverse
reactions to any immunizations were recorded. Id. The pediatrician’s checklist for the pediatric
visit held on July 16, 2004 indicated that J.H. was capable of rolling over in both directions and
“sits with support/alone.” Id. (quoting Ex. 4 at 25, Ex. 10 at 7).3
The first mention in the record of J.H.’s developmental delays was generated on October
14, 2004. On that date, a medical note chronicling J.H.’s pediatric visit stated that J.H. was not
rolling over and not sitting alone, indicating a loss of some skills between July and October
1The Entitlement Decision was rendered by a special master who had been assigned to
the case after the originally assigned special master had retired.
2In their motion, petitioners state that J.H. suffered “an obvious aggravation of any prior
condition.” Pet’rs’ Mot. at 1. Nonetheless, until the hearing held on the motion for review,
petitioners had not raised a significant-aggravation claim before the special masters. Such a
claim would require analysis under the six-part test outlined in Loving ex rel. Loving v. Secretary
of Dep’t of Health & Human Servs., 86 Fed. Cl. 135, 144 (2009). See W.C. v. Secretary of Dep’t
of Health & Human Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013). Petitioners did move at the
hearing to amend their petition for compensation to state such a claim. Hr’g Tr. 52:11-18 (Nov.
13, 2014). The court will address a putative significant-aggravation claim in the analysis that
follows.
3 The exhibits petitioners presented to the special masters are designated numerically,
while the government’s exhibits are marked with letters.
2

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 3 of 13
2004. Entitlement Decision at 5. J.H. was also observed to have decreased muscle tone on her
left extremity. Id.; Pet’rs’ Mot. at 3. J.H. received a first half-dose of the influenza virus vaccine
on that date. Entitlement Decision at 5. Petitioners testified that after the first influenza
vaccination they noticed that J.H. cried continuously, no longer slept through the night, and lost
her ability to support her own weight. Pet’rs’ Mot. at 3. J.H. received a second half-dose on
November 16, 2004, approximately one month after receiving the first half-dose. This dose was
received at a pediatric visit during which she was also referred to a neurologist. Id. at 5.4
J.H. had a PT evaluation at Children’s Memorial Hospital on December 9, 2004, at which
she was found to be “developmentally delayed with her attainment of gross motor milestones”
and suffered “[s]ignificantly decreased strength due to increased tone/spasticity at bilateral lower
extremities . . . [,] display[ed] decreased proximal trunk strength and neck extensor muscles,”
and “ha[d] increased tone/spasticity throughout bilateral lower extremities.” Pet’rs’ Mot. at 4
(quoting Ex. 4 at 368-69). At that time, J.H. was “unable to bring hands to midline or to grab for
toys.” Id. J.H.’s first neurological evaluation was performed by Dr. David Stumpf on December
20, 2004. Entitlement Decision at 5. Dr. Stumpf observed “increased tone in her lower
extremities” due to “great resistance to reach 90 degree[s] in flexion” and diagnosed J.H. with
spastic diplegia and cerebral palsy, which he suggested resulted from “twinning.” Pet’rs’ Mot. at
5 (quoting Ex. 4 at 371); Entitlement Decision at 6. Early in 2005, J.H. suffered a marked
neurological deterioration. For several months, J.H.’s mother reported that she gained no weight,
a fact reflected in her weight chart, which lists J.H. in the 75th percentile at 9 months of age, in
the 60th percentile at 12 months, in the 10th percentile by 15 months and only in the 5th
percentile at 18 months. Pet’rs’ Mot. at 4; see also Pet’rs’ Reply to Resp’t’s Post Hearing Mem.
at Exs. D, E, ECF No. 115. At her 12-month well-child pediatric visit on January 18, 2005, the
medical records indicate that although J.H. could use single words, drink from a cup with help,
and feed herself some solids, she was unable to pull to stand, walk independently, or grasp
objects and was no longer lifting her head. Pet’rs’ Mot. at 5; Entitlement Decision at 6. The
doctor assessed J.H. to be “well developed but with muscle weakness, motor delay.” Entitlement
Decision at 6 (quoting Ex. 10 at 9). J.H. also began physical therapy in early 2005, which her
parents reported improved her “prone activity, sitting and lower limb kicking;” her medical
records, however, noted that she was not “using her bilateral extremities as functionally as she
used to.” Id. (quoting Ex. 6 at 469).
Subsequently, J.H. was evaluated extensively at Children’s Memorial Hospital by a
number of physicians, including neurologists, geneticists, pediatricians, orthopedic surgeons, and
physical and rehabilitation specialists. Entitlement Decision at 6. In late March 2005, her
parents and physical therapist noted difficulty feeding, inability to maintain a sitting position,
and the onset of clenched fists. Id. When Dr. Stumpf reevaluated her on April 18, 2005, he
observed a significant increase in spasticity and noted that additional tests were needed to
determine whether J.H. had a degenerative disorder. Id. At her 15-month check-up on April 19,
2005, Dr. Peera assessed her with global developmental delays and “CP,” i.e., presumably,
cerebral palsy. Pet’rs’ Mot. at 6. J.H.’s swallowing function studies and MRIs with contrast of
the brain and cervical cord, administered in May 2005, were deemed normal. Entitlement
4There are no medical records for the period between the administration of the first and
second halves of the influenza vaccination. Pet’rs’ Mot. at 3.
3

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 4 of 13
Decision at 6. In June 2005, J.H.’s diagnosis of cerebral palsy was reassessed after Dr. Stumpf
found her to have atypical features. Id. at 7. During that time, she was diagnosed with “spastic
quadriplegia, etiology unclear” and was assessed at the Rehabilitation Institute of Chicago as
being characterized by “very poor head control [and] trunk control.” Entitlement Decision at 6
(quoting Ex. 4 at 334). Despite physical therapy, J.H.’s motor function worsened. Id. In
November 2005, J.H. was evaluated at the Mayo Clinic where, despite extensive testing, her
doctors could not agree on a diagnosis. Id.
In 2008, J.H. was evaluated by Mark Geier, M.D. who performed additional testing,
including an entire genome microarray, but was similarly unable to offer a diagnosis.
Entitlement Decision at 6. To date, J.H. has no definitive diagnosis for her neurological
condition. Id.
PROCEDURAL HISTORY
Mr. and Mrs. Hirmiz filed their petition for compensation on behalf of J.H. under the
Vaccine Act on May 8, 2006. Their original petition alleged that “a series of vaccinations
administered on March 15, 2004, May 17, 2004, [and] September 17 and 18, 2004” caused J.H.
to experience “a degeneration of her motor skills and body control noticeable after mid-October
of 2004.” Resp’t’s Mem. in Resp. to Pet’rs’ Mot. for Review (“Resp’t’s Mem.”) at 4, ECF No.
123 (quoting Pet’rs’ Pet. for Compensation, ECF No. 1). After the government contested that
claim, petitioners altered their position regarding the onset of J.H.’s condition in an amended
petition filed on March 5, 2007. Entitlement Decision at 4. Unlike the original petition, which
asserted that “J.H. progressed normally for about eight months,” the amended petition alleged
that J.H. progressed normally “for about over ten months, i.e., at least until October 14, 2004”
and asserted that J.H.’s failure to progress resulted from the half-dose influenza vaccines
administered on October 14, 2004 and November 16, 2004. Pet’rs’ Am. Pet. (filed with the court
in paper form) at 1.
On August 28, 2008, an “onset hearing” was held before the originally assigned special
master, at which petitioners testified about the onset of J.H.’s condition. Entitlement Decision at
4; Transcript of Proceedings, Aug. 28, 2008 (“2008 Tr.”), ECF No. 37 (submitted to the court in
paper form). On January 14, 2010, the special master issued a bench ruling, finding that the
onset of J.H.’s symptoms occurred between July 16, 2004 and October 14, 2004, before the
administration of J.H.’s influenza vaccinations:
[T]here is some form of regression which has been initiated prior to the
14th of October. It seems to deteriorate, or accelerate, rapidly between
October 14 and November, whatever the date was, perhaps the 16th,
yes, and thereafter. In fact, the records are replete with that acceleration
of degeneration of whatever the problem is.
Transcript of Proceedings, Jan. 14, 2010 (“2010 Tr.”), at 15, ECF No. 56; see also Hr’g Tr.
14:18 to 16:24 (Nov. 13, 2014).
4

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 5 of 13
Following the initially assigned special master’s retirement, the case was reassigned to
another special master. Entitlement Decision at 4.5 After the filing of expert reports by the
petitioners and the government, a second evidentiary hearing was held on December 5, 2012, to
hear testimony from the parties’ experts. Id. at 5; Transcript of Proceedings, Dec. 5, 2012
(“2012 Tr.”), ECF No. 104. During that hearing, petitioner’s expert, Dr. James M. Oleske,
testified that J.H.’s neurological condition was likely due to the two half dosages of influenza
vaccine she received at 9 and 10 months of age, which were temporally related to the onset of
her worsening neurological symptoms. Entitlement Decision at 8.6 Dr. Oleske asserted that a
severe decline started to occur at 12 months of age, causing her growth to decrease drastically
over the next three months. Id. at 8-9; 2012 Tr. at 20-22, 70. He suggested that J.H.’s
neurological deterioration may have been due to an unusual immunological response to the flu
vaccine. Entitlement Decision at 9. The government’s expert, Dr. Stephen J. McGeady,
disagreed and testified that there was no evidence in J.H.’s medical records that she suffered
immune dysfunction in her first six months of life and emphasized that J.H. received routine
immunizations early in her life without any reported adverse reactions. Id. at 9-10; 2012 Tr. at
77-78, 85.7 Dr. McGeady opined instead that J.H. demonstrated signs of a loss of skills between
July and October of 2004, before the administration of the influenza vaccinations. Entitlement
Decision at 10; 2012 Tr. at 87. According to Dr. McGeady’s testimony, “for an infant not to
have made significant physical skill acquisition between the ages of six and nine months (July to
October 2004) would have been highly abnormal, and to have lost skills in that time period
would be alarming.” Entitlement Decision at 10 (emphasis in original); 2012 Tr. at 82-83.
Dr. McGeady concluded that it was more likely than not that J.H.’s rapid deterioration in late
2004 was an extension of a neurodegenerative process that began before October 14, 2004.
Entitlement Decision at 10.
5Petitioners did not thereafter request that the new special master personally hear
testimony regarding the onset of J.H.’s condition. Resp’t’s Mem. at 5 n.5.
6Dr. Oleske is a pediatric immunologist, serving as a Professor at the School of Public
Health, University of Medicine and Dentistry of New Jersey, a Clinical Professor at the New
Jersey School of Nursing, and a Professor of Preventive Medicine and Pathology in the
Department of Pediatrics at the University of Medicine and Dentistry of New Jersey. Ex. 16 at 3.
His resume lists 212 peer-reviewed publications. Id. at 19-33. 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 Pediatric and Pediatric
Infectious Diseases, the American Board of Medical Laboratory Immunology, 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. Id. at 2.
7Dr. McGeady serves as Director of the Allergy and Clinical Immunology Training
Program at the Jefferson College of Medicine and as Chief, Allergy, Asthma, and Immunology
Division, DuPont Hospital for Children. Ex. B at 1. His resume lists 54 peer-reviewed articles.
Id. at 2-6. He is certified by the American Board of Pediatrics, the American Board of Allergy
and Immunology, and the Board of Diagnostic Laboratory Immunology. Id. at 1.
5

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 6 of 13
On August 26, 2014, the successor special master issued a decision denying
compensation to petitioners. Entitlement Decision at 2. The special master held that petitioners
failed to prove by a preponderance of the evidence that the half doses of influenza vaccine
administered to J.H. on October 14, 2004 and November 16, 2004 caused J.H.’s neurological
degeneration. Id. at 7, 20. In so holding, the special master relied on the three-prong framework
for establishing causation outlined in Althen, 418 F.3d 1274, requiring a petitioner to establish by
preponderant evidence that the vaccination caused the 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 the
vaccination and injury.
Entitlement Decision at 16 (quoting Althen, 418 F.3d at 1278).8
Regarding the first element of the Althen analysis, the special master observed that the
petitioners failed to show “that influenza vaccinations of any kind can cause the type of injury
from which J.H. suffers.” Entitlement Decision at 19 (original emphasis omitted). The special
master concluded that petitioners could not establish the first prong because their reliance on
“immune dysfunction” and “challenge/rechallenge” theories was insufficient to meet the burden
of demonstrating a plausible medical theory. Id. With regard to Althen’s second prong, the
special master noted that the petitioners did not meet their burden of establishing cause and
effect because they were unable to show that J.H. suffered rapid neurological downturns after
either of her influenza vaccinations. Id. In addition, the special master observed that petitioners
were unable to establish that J.H.’s case fit either an “immune dysfunction” or a “challenge/re-
challenge” scenario. Id. Finally, in analyzing the third prong of Althen, the special master
concluded that petitioners failed to demonstrate a proximate temporal relationship between the
influenza vaccinations and J.H.’s injury. Id. The special master found that petitioners’ expert,
Dr. Oleske, relied upon a flawed assumption of fact regarding the onset of J.H.’s neurological
disorder and failed to offer any persuasive evidence as to when the first symptoms of an
influenza-vaccine-caused disorder may appear. Id. at 19-20.
Petitioners filed a Motion for Review in this court on September 23, 2014.
STANDARDS FOR REVIEW
Under the Vaccine Act, in reviewing a decision of a special master on a motion for
review, the court may take any of the following actions:
8The special master noted that the Althen analysis could be applied despite J.H.’s lack of
an official diagnosis because both parties’ experts agreed that J.H. suffered neurological
degeneration and there is no affirmative burden on the petitioner to establish a specific diagnosis.
Entitlement Decision at 17-18 (citing Kelley v. Secretary of Health & Human Servs., 68 Fed. Cl.
84, 100 (2005) (“The Vaccine Act does not require petitioners coming under the non-Table
injury provision to categorize their injury; they are merely required to show that the vaccine in
question caused them injury—regardless of the ultimate diagnosis.”)).
6

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 7 of 13
(A) uphold the findings of fact and conclusions of law of the special master and
sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the special master found to be
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and
issue its own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in accordance with the
court’s direction.
42 U.S.C. § 300aa-12(e)(2).
The special master’s determinations of law are reviewed de novo, Andreu v. Secretary of
Health & Human Servs., 569 F.3d 1367, 1373 (Fed. Cir. 2009), and findings of fact are reviewed
for clear error, id.; see also Broekelschen v. Secretary of Health & Human Servs., 618 F.3d 1339,
1345 (Fed. Cir. 2010) (“We uphold the special master’s findings of fact unless they are arbitrary
or capricious.” (citing Capizzano v. Secretary of Health & Human Servs., 440 F.3d 1317, 1324
(Fed. Cir. 2006))). In making his determination, the special master must “consider all relevant
and reliable evidence.” Rule 8(b)(1) of the Vaccine Rules of the United States Court of Federal
Claims; see also 42 U.S.C. § 300aa-13(b)(1) (“[T]he special master or court shall consider the
entire record and the cause of the injury, disability, illness, or condition until the date of the
judgment of the special master or court.”). A special master’s findings regarding the probative
value of presented evidence and the credibility of witnesses will not be disturbed so long as they
are “supported by substantial evidence.” Doe v. Secretary of Health & Human Servs., 601 F.3d
1349, 1355 (Fed. Cir. 2010) (citing Whitecotton v. Secretary of Health & Human Servs., 81 F.3d
1099, 1105 (Fed. Cir. 1996)); see also Porter v. Secretary of Health & Human Servs., 663 F.3d
1242, 1249 (Fed. Cir. 2011). Nonetheless, a deferential standard of review “is not a rubber
stamp.” Porter, 663 F.3d at 1256 (O’Malley, J., concurring in part and dissenting in part). The
special master must draw plausible inferences and articulate a rational basis for his decision.
Hines ex rel. Sevier v. Secretary of the Dep’t of Health & Human Servs., 940 F.2d 1518, 1528
(Fed. Cir. 1991); see 42 U.S.C. § 300aa-13(b)(1). Although the special master need not address
every individual piece of evidence presented in the case, see Doe, 601 F.3d at 1355; he cannot
dismiss contrary evidence to the extent that it appears that he “simply failed to consider
genuinely the evidentiary record before him,” Campbell v. Secretary of Health & Human Servs.,
97 Fed. Cl. 650, 668 (2011); see also Paluck ex rel. Paluck v. Secretary of Health & Human
Servs., 104 Fed. Cl. 457, 467 (2012).
The Vaccine Act was originally adopted by Congress to “establish a [f]ederal ‘no-fault’
compensation program under which awards can be made to vaccine-injured persons quickly,
easily, and with certainty and generosity.” H.R. Rep. No. 99-908, at 3 (2d Sess. 1986), reprinted
in 1986 U.S.C.C.A.N. 6334, 6334. Congress established a Vaccine Injury Table to allow for a
generous remedial program.9 For cases falling within the timing and other specifications of a
Table injury, causation is conclusively presumed. Hodges v. Secretary of Health & Human
9The original Vaccine Injury Table was published at 42 U.S.C. § 300aa-14(a). The
Secretary of Health and Human Services has periodically revised the Table pursuant to notice-
and-comment rulemaking under the authority of 42 U.S.C. § 300aa-14(c), and the current version
of the Vaccine Injury Table, as amended, is set out at 42 C.F.R. § 100.3.
7

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 8 of 13
Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). For claims falling outside the scope of the Table,
however, the claimant is required to prove causation in fact by a preponderance of the evidence.
42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), -13(a)(1)(A); Althen, 418 F.3d at 1278.
Causation in fact is proved by a petitioner who satisfies each of three Althen factors by
preponderant evidence. Althen, 418 F.3d at 1278 (quoted supra, at 6). Expanding on these
criteria for establishing causation, the Federal Circuit stated that “[a] persuasive medical theory
is demonstrated by proof of a logical sequence of cause and effect showing that the vaccination
was the reason for the injury, the logical sequence being supported by reputable medical or
scientific explanation, i.e., evidence in the form of scientific studies or expert medical
testimony.” Id. (citation omitted) (internal quotations omitted). Once the petitioner has made a
prima facie case of causation, “the burden shifts to the government to prove by a preponderance
of the evidence that the petitioner’s injury is due to factors unrelated to the administration of the
vaccine . . . .” de Bazan v. Secretary of Health & Human Servs., 539 F.3d 1347, 1352 (citation
omitted) (internal quotation omitted).
The Federal Circuit has interpreted the “preponderance of the evidence” standard for
Vaccine Act cases as the same as the standard used in traditional tort cases, see Moberly ex rel.
Moberly v. Secretary of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010), requiring the
claimant to establish “more probable than not” causation, Althen, 418 F.3d at 1279 (citation
omitted). “‘[C]lose calls regarding causation are resolved in favor of injured claimants.’”
Andreu, 569 F.3d at 1378 (quoting Capizzano, 440 F.3d at 1325-26). The preponderance
standard employed by the Vaccine Act “allow[s] the finding of causation in a field bereft of
complete and direct proof of how vaccines affect the human body,” Althen, 418 F.3d at 1280.
Thus, proof by a preponderance of the evidence does not require “scientific certainty.” Bunting
v. Secretary of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Rather, determi-
nation of causation under the Act involves “ascertaining whether a sequence of cause and effect
is ‘logical’ and legally probable, not medically or scientifically certain.” Knudsen ex rel.
Knudsen v. Secretary of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994) (citations
omitted). Therefore, a finding of causation in fact in vaccine cases can be “based on
epidemiological evidence and the clinical picture . . . without detailed medical and scientific
exposition on the biological mechanisms.” Id. at 549 (citing Jay v. Secretary of the Dep’t of
Health & Human Servs., 998 F.2d 979, 984 (Fed. Cir. 1993)).
While a special master may base his or her decision on medical opinion alone, Althen,
418 F.3d at 1279-80, he or she is “entitled to require some indicia of reliability to support the
assertion of the expert witness.” Moberly, 592 F.3d at 1324 (citing Terran v. Secretary of Health
& Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999)). In addition, the special master may
also consider medical literature or epidemiological evidence in reaching an informed judgment
as to whether a particular vaccination caused a particular injury. See LaLonde v. Secretary of
Health & Human Servs., 746 F.3d 1334, 1339-40 (Fed. Cir. 2014).
ANALYSIS
Based on the lack of a formal diagnosis for J.H.’s severe neurological impairment, it is
undisputed that petitioners’ claim involves an “off-Table” condition, i.e. an injury not listed in
the Vaccine Injury Table delineated in 42 U.S.C. § 300aa-14(a). See 42 U.S.C. § 300aa-
8

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 9 of 13
11(c)(1)(C)(ii). Accordingly, petitioners bear the burden of proving causation in fact by a
preponderance of the evidence. Based upon the record, four separate possible theories of J.H.’s
condition have been or may be posited:
1. Challenge/Rechallenge Scenario: J.H. was healthy until she received the October
2004 injection; she had adverse reaction then; in November 2004 she received a
second dose; and her condition soon became drastically worse.
2. All Other Possible Causes Have Been Eliminated: J.H.’s condition (according
to medical experts) must have been prompted by a trigger; extensive testing has
eliminated all other potential causes of her condition, leaving only the influenza
vaccinations, implicating a theory akin to res ipsa loquitur.
3. Exacerbation of Underlying Condition: J.H. suffered from an underlying
immunological condition prior to October 2004, but the half-doses of the
influenza vaccination caused her condition to develop into a severe neurological
impairment.
4. Other Vaccination Received in July 2004 was Cause: Plaintiff’s expert
Dr. Oleske, admitted that J.H.’s receipt of other vaccines in July 2004 was
a possible cause of J.H.’s impaired condition, but claimed this possibility
was mere “speculation” because it could not be proven.
Conceptually, possibilities 1, 2, and 4 fit within the Althen causation principles, while possibility
3 would require consideration of the Loving significant-exacerbation factors.
A. Causation Under Althen Factors
The special master’s denial of the petitioners’ petition rested largely on evidence
suggesting that J.H.’s neurological degeneration predated her receipt of the two half-doses of the
influenza vaccine on October 14, 2004 and November 16, 2004, respectively. The second
special master found Dr. McGready’s testimony to this effect more persuasive than the contrary
view of Dr. Oleske, which the second special master concluded suffered from several
deficiencies. Entitlement Decision at 10. Most importantly, the special master noted that Dr.
Oleske based his opinion on a “plainly flawed” assumption regarding the onset of J.H.’s
neurological symptoms. Id. at 10-11. While Dr. Oleske concluded that J.H.’s symptoms did not
begin until after her first influenza vaccination on October 14, 2004, the special master observed
that this testimony was refuted by both the findings of the original special master after the 2008
onset hearing and J.H.’s medical records.
The special master’s conclusion regarding the onset of J.H.’s symptoms is supported by
both the facts and the record. J.H.’s medical records document a change in J.H.’s circumstances
between her six-month visit with Dr. Peera in July of 2004 and her nine-month visit on October
14, 2004. Entitlement Decision at 11. At six months of age J.H. was able to roll over in both
directions, reach for objects, babble, and appeared normal for her age. At nine months, however,
J.H. was no longer rolling over or sitting alone and had decreased muscle tone in her lower
9

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 10 of 13
extremities. Id. The testimony of J.H.’s parents similarly supports that the onset of J.H.’s
condition occurred prior to October of 2004. In several different medical histories, J.H.’s parents
noted that her development began to fall behind that of her twin brother at about six months of
age, in July 2004. Id. at 12. Finally, the records of J.H.’s visit to the Mayo Clinic identify July
to September of 2004 as the period of the first symptoms of her neurological deterioration. Id.
The original special master at the onset hearing weighed the testimony of J.H’s parents with that
of her medical records. Id. He noted that while he found J.H.’s parents to be “credible” and
“moral” people, he believed that the medical records as a whole indicated that J.H.’s
neurological development was deficient in July of 2004. 2010 Tr. at 10.
Petitioners argue that the second special master ignored a significant portion of the record
in rendering his decision. Specifically, they emphasize that the original special master stated that
J.H.’s condition was a “form of retrogression” which initiated before October 14th, 2004. In this
first special master’s view, J.H.’s condition “seem[ed] to deteriorate, or accelerate, rapidly
between October 14 and November [16th] and thereafter,” demonstrating an “acceleration or
degeneration of whatever the problem is.” 2010 Tr. at 15. They contend that the second special
master’s lack of acknowledgment of the first special master’s statements about acceleration,
coupled with other probative evidence, including dated photographs of J.H.’s worsening
condition over time, amounted to impermissibly “don[ning] blinders to the portion of [an
evidentiary] letter that contradicted his findings.” Pet’rs’ Mot. at 15 (quoting Shapiro v.
Secretary of Health and Human Services, 105 Fed. Cl. 353, 357 (2012), aff’d, 503 Fed. Appx.
952 (Fed. Cir. 2013)). Contrary to petitioners’ contention, however, there is no indication in the
second special master’s thorough opinion that he failed to consider the evidence petitioners cite.
In the opinion, the second special master explained that he reviewed the findings of the first
special master and also conducted a detailed review of both the testimony of J.H.’s parents and
notations in J.H.’s medical records. Entitlement Decision at 12. Furthermore, the first special
master’s bench ruling does not conflict with the second special master’s decision. The first
special master deliberately refrained from drawing any medical conclusions in his ruling. He
neither identified a cause for J.H.’s neurological nose-dive nor suggested that the influenza
vaccination itself aggravated her condition; he merely identified a time – a period undisputed by
the parties – during which J.H.’s symptoms worsened significantly. The second special master
accepted that J.H. experienced a dramatic neurological decline in the period after October 14th,
but concluded through his analysis of the Althen factors that the evidence did not demonstrate
that the decline was caused by J.H.’s vaccinations. Id. at 19-20.
In addition, the second special master undertook an overall review of petitioners’ various
theories of causation. First, he addressed petitioners’ theory that an unusual immunological
response to the influenza vaccine contributed to J.H.’s neurological disorder. Entitlement
Decision at 13-15. His rejection of this theory was based on the absence of any medical
literature or any plausible explanation by Dr. Oleske indicating that the influenza vaccine was
capable of causing an unusual immunological response that could lead to a severe neurological
decline. Id. In that respect, Dr. McGeady explained that nothing in J.H.’s records indicated that
J.H. was immunologically abnormal or unusually susceptible to infections. Id. Petitioners
dispute Dr. McGeady’s conclusion that J.H. was immunologically normal after the flu
vaccinations, relying primarily on results from tests at the Mayo Clinic in 2005. See Hr’g Tr.
22:16 to 23:1 (Nov. 13, 2014) (“We have the flu vaccination coming in, we have the theory that
10

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 11 of 13
it could be an autoimmune reaction, and we have the evidence from the Mayo Clinic and from
Children’s Hospital of evidence of an immune response in her central nervous system. So, we
know there’s an auto — there’s a possibility of an autoimmune reaction. We have symptoms of
it. We have fingerprints of it in the tests. They are slight fingerprints, but they are fingerprints.
And then we have the work of Children’s Hospital excluding everything else.”). To further
support the theory of an autoimmune reaction, petitioners point to two autoimmune conditions,
Guillain-Barré syndrome and Chronic Inflammatory Demyelinating Polyneuropathy, both of
which are known to be caused by flu vaccines. Pet’rs’ Mot. at 8 (citing Dr. Oleske’s testimony,
Ex. 17 at 3-4).10 The special master discounted those conditions as providing any analogy to
J.H.’s condition, commenting that “Dr. Oleske failed to point to any medical articles or other
actual evidence demonstrating that influenza inoculations can injure the brain.” Entitlement
Decision at 13.
Second, the special master’s rejection of petitioners’ “challenge/rechallenge” theory of
causation was supported by the fact that J.H. suffered the first symptoms of her neurological
disorder before her first influenza vaccination, which is inconsistent with a “challenge/re-
challenge” scenario. Id. at 15.11 Although the special master’s decision did not appear to
address in this context the significant worsening of J.H.’s condition in late 2004 and early 2005,
those changes did not follow immediately after the half-dose influenza vaccinations.
B. Signification Aggravation Theory
During the hearing held on November 13, 2014, petitioners moved to amend their
petition for compensation to incorporate a significant-aggravation claim, arguing that an
autoimmune reaction to the flu vaccine may have exacerbated an underlying condition, resulting
in J.H.’s neurological decline. Hr’g Tr. 52:11-14, 50:14-19 (Nov. 13, 2014) (“[I]f the pleadings
don’t cover the aggravation, I move to amend the pleadings to conform that proof, as we do all
the time in court when things turn out differently.”). In support of their theory, petitioners cite
results from the Mayo Clinic and Children’s Hospital suggestive of an autoimmune reaction and
the general timing of J.H.’s accelerated neurological decline, which followed her receipt of the
vaccines. Hr’g Tr. 22:16 to 23:19 (Nov. 13, 2014). The government counters that a significant-
aggravation claim was never fully developed in the pleadings or by petitioners’ expert. Hr’g Tr.
39:11-21 (Nov. 13, 2014).
10Guillain-Barré syndrome is a disorder in which the body’s immune system attacks part
of the peripheral nervous system. Chronic Inflammatory Demyelinating Polyneuropathy is a
neurological disorder characterized by progressive weakness and impaired sensory function in
the arms and legs. This condition is often considered the chronic counterpart to the acute
Guillain-Barré syndrome.
11A “challenge/rechallenge” circumstance exists when a person has a reaction to one
administration of a vaccine or drug and then suffers worsened symptoms after an additional
administration of the same vaccine or drug. Entitlement Decision at 15. A challenge/rechallenge
theory can be used to establish causation. Id. (citing Capizzano v. Secretary of Health & Human
Servs., No. 00-759V, 2004 WL 1399178 (Fed. Cl. Sp. Mstr. June 8, 2004), aff’d, 63 Fed. Cl. 227
(2004), rev’d on other grounds, 440 F.3d 1317 (Fed. Cir. 2006)).
11

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 12 of 13
Under Rule 15(b)(2) of the Rules of the Court of Federal Claims (“RCFC”), a party may
move at any time to amend the pleadings to incorporate an issue that is tried by the parties’
express or implied consent.12 The decision to grant such a motion rests in the sound discretion of
the trial court. See Grand Light & Supply Co. v. Honeywell, Inc., 771 F.2d 672, 680 (2d Cir.
1985) (citing Browning Debenture Holders’ Comm. v. DASA Corp., 560 F.2d 1078, 1086 (2d
Cir. 1977)).13 The purpose of RCFC 15(b) is to enable the pleadings to conform to issues
“actually tried, not to extend the pleadings to introduce issues inferentially suggested by
incidental evidence in the record.” Id. (quoting Browning Debenture, 560 F.2d at 1086). The
rule should also be applied in a manner that avoids unfair prejudice, which may occur where a
party seeks to apply evidence presented on a separate issue to a new claim added after conclusion
of the trial, see id. at 680 (citing Zenith Radio Corp. v. Hazeltine Research, Inc., 401 U.S. 321,
330–31 (1971); Cook v. City of Price, 566 F.2d 699, 702 (10th Cir. 1977)), or if the opposing
party did not have the opportunity to defend against the new claim and might have offered
additional evidence had it been aware of the claim, see id. (citing International Harvester Credit
Corp. v. East Coast Truck, 547 F.2d 888, 890 (5th Cir. 1977)).
In this instance, petitioners waited to raise a significant-aggravation claim until after a
decision was rendered by the special master following the conclusion of percipient witness and
expert testimony. While the evidence cited by petitioners that would support a significant-
aggravation theory was submitted at the hearings before both special masters, it was submitted in
support of separate and distinct theories of causation, i.e., a challenge/rechallenge scenario and
an immunological response causing neurological dysfunction beginning after the administration
of the influenza vaccine. Therefore, the issue of significant aggravation is “inferentially
suggested by incidental evidence” rather than “actually tried,” Grand Light, 771 F.2d at 680
(citation omitted), and there was no implied consent by the government to try the issue in the
underlying proceedings, see, e.g., Paul Revere Life Ins. Co., 354 F.3d 1005, 1013 (9th Cir. 2004)
(noting that Fed. R. Civ. P. 15(b) “does not permit amendments to include issues which may be
[merely] inferentially suggested by incidental evidence in record” (citations omitted)); DRR, LLC
v. Sears, Roebuck and Co., 171 F.R.D. 162, 165 (D. Del. 1997) (finding the issue was not tried
by implied consent of parties when relevant evidence was introduced at trial only in support of
original claim and the opposing party was not put on notice that the issue was being tried);
Metcalf Const. Co. v. United States, 102 Fed. Cl. 334, 343 (2011) (noting “where evidence is
introduced at trial to establish a properly pled issue, implied consent may not be assumed as to
issues not pled”).
12RCFC 15(b)(2) states in pertinent part:
When an issue not raised by the pleadings is tried by the parties' express or
implied consent, it must be treated in all respects as if raised in the pleadings. A
party may move--at any time, even after judgment--to amend the pleadings to
conform them to the evidence and to raise an unpleaded issue. But failure to
amend does not affect the result of the trial of that issue.
RCFC 15(b)(2).
13RCFC 15(b) mirrors Fed. R. Civ. P. 15(b). The court accordingly will look to
precedents applying Fed. R. Civ. P. 15(b) in addition to those addressing RCFC 15(b).
12

Case 1:06-vv-00371-CFL Document 129 Filed 12/19/14 Page 13 of 13
Moreover, allowing the claim at this stage of the litigation, over eight years after the
filing of the original petition for compensation in May 2006, would unfairly prejudice the
government. See Baker v. Goldman, Sachs & Co., __ F.3d __, __, 2014 WL 5840501, at *12
(1st Cir. Nov. 12, 2014) (noting that plaintiffs’ general argument that the defendant’s failure to
disclose relevant facts about a transaction in violation of a specific statute was insufficient to put
defendant on notice of a claim falling under a different statute); Rodriguez v. Doral Mortg.
Corp., 57 F.3d 1168, 1172 (1st Cir. 1995) (plaintiff may not “leave defendants to forage in
forests of facts, searching at their peril for every legal theory that a court may some day find
lurking in the penumbra of the record”). Notably, the legal test for significant-aggravation
claims differs from that applicable to petitioners’ other claims.14 Importantly also, no testimony
whatsoever has been presented on a significant-aggravation theory by an expert witness. Indeed,
petitioners concede that a significant-aggravation theory would contradict the testimony of their
own expert, Dr. Oleske, who testified that J.H. developed normally until October 14, 2014. Hr’g
Tr. 51:15-17 (Nov. 13, 2014) (“Dr. Oleske still doesn’t believe this child had a problem in the
summertime. He and I disagree.”). In these circumstances, the court declines to permit
petitioners to amend their petition to incorporate a significant-aggravation claim at this stage of
the proceedings.
C. Synopsis
In sum, due to evidence that the onset of J.H.’s condition occurred prior to the
administration of the two half-dose influenza vaccinations and the lack of evidence supporting
the persuasiveness of petitioners’ proffered medical theories, the court finds that the special
master weighed the evidence of record and made determinations in accord with law. Applying
the pertinent evidentiary standard, the court concludes that the special master’s finding of a lack
of causation was supported by substantial evidence and was neither arbitrary nor an abuse of
discretion.
CONCLUSION
For the reasons stated, petitioners’ motion for review is DENIED, and the decision of the
special master rendered on August 26, 2014 is AFFIRMED.
It is so ORDERED.
s/ Charles F. Lettow
Charles F. Lettow
Judge
14The six-part Loving test that pertains to a significant-aggravation claim, see Loving, 86
Fed. Cl. 135, adds three factors to the causation criteria specified in Althen, see supra, at 2 n.2.
13

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_06-vv-00371-3
Date issued/filed: 2017-12-07
Pages: 11
Docket text: JUDGE VACCINE REISSUED REPORTED OPINION re: 144 Order on Motion for Review, Judge Vaccine Reported Opinion originally filed November 22, 2017. Signed by Judge Charles F. Lettow. (je)
--------------------------------------------------------------------------------
Case 1:06-vv-00371-CFL Document 146 Filed 12/07/17 Page 1 of 11
In the United States Court of Federal Claims
No. 06-371V
(Filed: November 22, 2017 )
(Reissued: December 7, 2017)
)
FRANCIA HIRMIZ and PETER HIRMIZ, ) Vaccine case; attorneys’ fees and
as best friends of their daughter, J.H., ) costs; reasonable basis for appeal
)
Petitioner, )
)
v. )
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
John F. McHugh, Law Office of John McHugh, New York, NY for petitioners.
Ryan D. Pyles, Trial Attorney, Torts Branch, Civil Division, United States Department of
Justice, Washington, D.C., for respondent. With him on the brief was Chad A. Readler, Acting
Assistant Attorney General, Civil Division, and C. Salvatore D’Alessio, Acting Director, Torts
Branch, Catharine E. Reeves, Deputy Director, Torts Branch, and Heather L. Pearlman, Assistant
Director, Torts Branch, Civil Division, United States Department of Justice, Washington, D.C.
OPINION AND ORDER1
LETTOW, Judge.
In 2006, Francia and Peter Hirmiz filed a petition on behalf of their daughter, J.H., for
compensation under the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, tit.
III, §§ 301-323, 100 Stat. 3743, 3755 (1986) (currently codified, as amended, at 42
U.S.C. § 300aa-1 et seq.) (the “Vaccine Act”). J.H. suffered severe neurological degeneration
after receiving two half-doses of influenza vaccine. See Hirmiz v. Secretary of Health & Human
Servs., 119 Fed. Cl. 209, 211 (2014), aff’d, 618 Fed Appx. 1033 (Fed. Cir. 2015) (disposition by
Fed. Cir. R. 36). Extensive proceedings ensued before special masters, including two evidentiary
hearings, and ultimately a decision was rendered denying J.H. entitlement to an award on the
ground that causation had not been established by a preponderance of the evidence. See Hirmiz
v. Secretary of Health & Human Servs., No. 06-371V, 2014 WL 4638375, at *16 (Fed. Cl. Spec.
1In accord with the Rules of the Court of Federal Claims (“RCFC”), App. B, Rule 18(b),
this opinion and order was initially filed under seal. By rule, the parties were afforded fourteen
days within which to propose redactions.

Case 1:06-vv-00371-CFL Document 146 Filed 12/07/17 Page 2 of 11
Mstr. Aug. 26, 2014) (“Entitlement Decision”). On review by this court, that determination was
upheld, and an appeal to the United States Court of Appeals for the Federal Circuit was not
successful. Hirmiz, 119 Fed. Cl. 209, aff’d, 618 Fed. Appx. 1033. Now, petitioners seek review
of a subsequent decision by a special master denying attorneys’ fees for the appeal taken to the
Federal Circuit, for a petition for rehearing and rehearing en banc before the Federal Circuit, and
for the submission of a petition for a writ of certiorari to the United States Supreme Court.2
Even where a petitioner is unsuccessful in obtaining compensation under the Vaccine
Act, the special master nevertheless “may award an amount of compensation to cover
petitioners’ reasonable attorneys’ fees and other costs incurred in any proceeding on such
petition if the special master . . . determines that the petition was brought in good faith and there
was a reasonable basis for the claim for which the petition was brought.” 42 U.S.C. § 300aa-
15(e); see Simmons v. Secretary of Health & Human Servs., 875 F.3d 632 (Fed. Cir. 2017). The
special master awarded $121,906.00 for attorneys’ fees and costs and $991.00 for petitioners’
own litigation expenses, covering petitioners’ counsel’s work during the entitlement phase of the
case and the motion for review before this court. See Hirmiz v. Secretary of Health & Human
Servs., No. 06-371V, 2017 WL 4277433 (Fed. Cl. Spec. Mstr. Aug. 29, 2017) (“Attorneys’ Fee
Decision”), slip op. at 17. The special master nonetheless declined to award fees for any of the
legal work performed by petitioners’ counsel in furtherance of the appeal to the Federal Circuit
and thereafter because the special master found that the appeal was lacking a reasonable basis.
Id., slip op. at 13-14. Petitioners contest the special master’s determination of the basis for their
appeal and seek to have the special master’s decision denying attorneys’ fees for petitioners’
appellate work overturned, but do not contest other components of the Attorneys’ Fee Decision.
See Pet.’rs’ Mot. for Review (“Pet’rs’ Mot.”) at 4, ECF No. 136. The Secretary has responded,
Resp’t’s Resp., ECF No. 140, petitioners have replied, Pet’rs’ Reply, ECF No. 141, and a
hearing on this motion was held on October 25, 2017.
BACKGROUND
J.H.’s tragic and convoluted medical history was narrated at length in prior opinions.
See, e.g., Hirmiz, 119 Fed. Cl. at 211-15 (noting that J.H. has no confirmed diagnosis for her
severe neurological disability notwithstanding numerous evaluations, including testing at
Children’s Memorial Hospital and the Mayo Clinic). That history will not be recounted here. In
the course of this litigation, petitioners’ counsel and retained experts undertook substantial work
on petitioners’ behalf. At a midpoint in the proceedings before the special master, petitioners
filed an application for an award of interim fees for legal work their counsel performed between
November 2004 and July 2010. See Attorneys’ Fee Decision, slip op. at 3. At that juncture, the
special master awarded a total of $87,049.45 for interim attorneys’ fees and costs, encompassing
2The Vaccine Act prohibits attorneys from charging any fee for services in connection
with a vaccine injury petition. See Sebelius v. Cloer, 589 U.S. 369, 373 (2013) (citing 42 U.S.C.
§ 300aa-15(e)(3)). “Instead, the special master or court awards attorneys’ fees and costs, and
[such] award[s are] paid from the Federal Vaccine Trust Fund.” Raymo v. Secretary of Health &
Human Servs., 129 Fed. Cl. 691, 701 (2016) (citing 42 U.S.C. § 300aa-15(e)(1), (f)(4), (i)(2); see
also Rehn v. Secretary of Health & Human Servs., 126 Fed. Cl. 86, 91 (2016)).
2

Case 1:06-vv-00371-CFL Document 146 Filed 12/07/17 Page 3 of 11
time spent on the initial stages of the case and then on an evidentiary hearing that focused on
J.H.’s symptoms and their onset. Id.
A further evidentiary hearing was held in December 2012 to receive testimony on
causation from expert witnesses, and thereafter post-hearing briefs were received. Attorneys’
Fee Decision, slip op. at 4. In August 2014, the special master issued a decision denying
entitlement to an award of compensation. See Entitlement Decision.
Following the Entitlement Decision, petitioners brought a motion for review before this
court and then an appeal to the Federal Circuit, both of which proved to be unsuccessful. In
each, they argued that the special master’s decision was arbitrary and capricious as to salient
findings of fact. Specifically, petitioners argued that the special master’s adverse findings on
three issues central to the Entitlement Decision should be reversed: (1) recognizing that J.H.
experienced severe neurological degeneration after receiving two half-doses of influenza
vaccine, was she able to show a medical theory connecting the vaccination to the injury?; (2) was
J.H. suffering from an underlying condition prior to her vaccination, resulting in a significant-
aggravation claim rather than a straightforward causation claim?; and (3) was J.H. able to show a
temporal relationship between the vaccination and the onset of her injuries? See Pet’rs’
Appellate Brief, at 1-2, Hirmiz v. Secretary of Health & Human Servs., No. 2015-5043, ECF.
No. 18 (“Pet’rs’ Appellate Br.”). The Federal Circuit’s affirmance of this court’s decision was
without opinion pursuant to Federal Circuit Rule 36. See Hirmiz, 618 Fed. Appx. 1033.
Beginning with their motion for review in this court and continuing in their appeal to the
Federal Circuit, petitioners briefly alluded to a constitutional argument as to the proper standard
of review to be applied in reviewing entitlement decisions under the Vaccine Act.3 Petitioners’
3Underpinning petitioners’ argument as to the standard of review was the Supreme
Court’s decision in Stern v. Marshall, 564 U.S. 462 (2011). In that case, the Court heard a
challenge to the constitutionality of a ruling by a United States Bankruptcy Court on a
counterclaim arising under the common law of tort. In that context, the Court determined that
Article III of the Constitution prohibited the exercise of the “judicial Power of the United States”
by a tribunal that did not have the tenure and guarantees provided by Article III. 564 U.S. at
482-85 (relying on U.S. Const., Art. III, § 1). Stern held that allowing Congress to empower a
non-Article III court to rule with dispositive force on “matter[s] which, from [their] nature, [are]
the subject of a suit at the common law,” would violate Article III of the Constitution. Id. at 484-
85 (citing Murray’s Lessee v. Hoboken Land & Improvement Co., 59 U.S. (18 How.) 272, 284
(1856). The Court distinguished matters in the class of “public rights” that included “only
[those] matters arising between individuals and the [g]overnment in connection with the
performance of the constitutional functions of the executive or legislative departments that
historically could have been determined exclusively by those branches.” Id. at 485 (citing
Northern Pipeline Construction Co. v. Marathon Pipe Line Co., 458 U.S. 50, 67-68 (1982)
(internal quotations and ellipses omitted)). Based upon the reasoning of Stern, petitioners argued
on petition for rehearing that a vaccine injury claim, like the tortious interference claim at issue
in Stern, was not within the class of “public rights” over which Congress could constitutionally
vest authority in an Article I tribunal like the Court of Federal Claims’ Office of Special Masters.
From that premise, petitioners argued that the provisions of the Vaccine Act that mandate a
3

Case 1:06-vv-00371-CFL Document 146 Filed 12/07/17 Page 4 of 11
appeal to the Federal Circuit advanced this argument in a cursory manner—without expressly
stating the constitutional basis for their contention and notably without citing or discussing Stern
v. Marshall. See Pet’r’s Appellate Brief at 17-18. In petitioners’ appellate reply brief, the
argument was similarly not fleshed out. See Pet’rs’ Resp. at 6-7, Hirmiz v. Secretary of Health
& Human Servs., No. 2015-5043, ECF No. 24.
Following the Federal Circuit’s summary affirmance, petitioners filed a petition for
rehearing by the panel and for rehearing by the Federal Circuit sitting en banc. See Pet’rs’ Pet.
for Reh’g & Reh’g en banc, Hirmiz v. Secretary of Health & Human Servs., No. 2015-5043,
Doc. No. 34. In this subsequent petition to the Federal Circuit and thereafter in their petition for
writ of certiorari to the Supreme Court, petitioners no longer raised any factual arguments, but
instead argued solely for a heightened standard of review premised on Stern v. Marshall. Id.
The Federal Circuit denied petitioners’ motions for rehearing and for rehearing en banc,
Order Den. Pet’rs’ Mot. for Reh’g & Reh’g en banc, Hirmiz v. Secretary of Health & Human
Servs., No. 2015-5043, ECF. No. 36, and the Supreme Court denied petitioners’ petition for a
writ of certiorari, see Hirmiz v. Secretary of Health & Human Servs., No. 15-1249, 2016 WL
1388064 (U.S.), cert. den. sub nom. Hirmiz v. Burwell, 136 S.Ct. 2417 (2016).
Following the appellate litigation, petitioners prepared and submitted an application for
attorneys’ fees under 42 U.S.C. § 300aa-15(e). See Fee Application, Exs. 2, 11, 13, ECF No.
133. Petitioners sought fees for legal work associated with their second evidentiary hearing,
post-hearing briefing and proceedings before the special master on entitlement, the motion for
review before this court, their unsuccessful appeal to the Federal Circuit, and the petitions for
rehearing and for certiorari to the Supreme Court. Id.
The special master’s Attorneys’ Fee Decision calculated the hours petitioners’ counsel
billed for the appellate activity in this case to be 198.4 hours for Mr. McHugh and 65.4 hours for
Mr. Gaynor. Attorneys’ Fee Decision, slip op. at 16-17.4 By the special master’s calculation, the
fee requested for this work totaled $104,923.00. Id.5 Petitioners’ Fee Application indicates that
deferential standard of review for findings of fact made by special masters violates Article III of
the Constitution. See, e.g., Hirmiz, 2016 WL 1388064, at *4. A matching argument was
addressed and rejected by the Federal Circuit in Milik v. Secretary of Health & Human Servs.,
822 F.3d 1367, 1375-79 (Fed. Cir. 2016).
4The Attorneys’ Fee Decision makes no direct mention of the hours billed by Mr. Gaynor
for petitioners’ appellate activity, but the calculations it makes report 4.6 hours billed in 2015
and 72.4 hours billed in 2016. Attorneys’ Fee Decision, slip op. at 17. As Mr. Gaynor’s time
sheet indicates, he billed 4.6 hours in 2015, and 67.8 hours in 2016 (56.0 hours on the litigation
before the Supreme Court and 11.8 hours on the preparation of the Fee Application). Fee
Application Exs. 11, 13. The special master appeared to double count the 4.6 hours spent on the
Federal Circuit litigation in both 2015 and 2016.
5There is some discrepancy between the hours indicated in the special master’s discussion
of the Fee Application, the special master’s tabulation of the amounts requested and to be
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Mr. McHugh billed 166.35 hours in litigating the appeal before the Federal Circuit, 6.5 hours on
the petitions for rehearing, and 25.58 hours for the petition to the Supreme Court. Mr. Gaynor
billed 3.1 hours for litigating the appeal before the Federal Circuit, 1.5 hours on the petitions for
rehearing, and 56 hours for the petition to the Supreme Court. Id. Using the hours as reported in
the Fee Application, and the hourly rates that the special master determined were reasonable in
light of counsel’s legal experience, the court notes that petitioners are requesting an award in the
amount of $103,086.70. See Attorneys’ Fee Decision, slip op. at 5, 7-8, 16-17; Fee Application,
Exs. 2, 11, 13. The special master declined to award any attorneys’ fees billed for the
proceedings before the Federal Circuit and the Supreme Court, see Attorneys’ Fee Decision, slip
op. at 16-17, and it is this determination that petitioners contest at this juncture, Pet’rs’ Mot. at 6.
STANDARDS FOR DECISION
A. Good Faith and Reasonable Basis
Petitioners were ultimately unsuccessful on their claims, and the question at hand is
whether petitioners’ appeals were “brought in good faith and [upon] a reasonable basis” and thus
support an award of fees and costs. 42 U.S.C. § 300aa-15(e). “[G]ood faith and reasonable basis
are two distinct facets” of this inquiry. Simmons, 875 F.3d at 635 (quoting Chuisano v. United
States, 116 Fed. Cl. 276, 289 (2014)). Good faith is presumed in the absence of evidence of bad
faith. See Grice v. Secretary of Health & Human Servs., 36 Fed. Cl. 114, 121 (1996). In
contrast, a reasonable basis is not presumed, but rather is typically viewed as “an objective
standard determined by the totality of the circumstances.” Chuisano, 116 Fed. Cl. at 286
(internal quotations omitted); see also McKellar v. Secretary of Health & Human Servs., 101
Fed. Cl. 297, 303 (2011). In establishing that a reasonable basis exists, “[t]he burden is on the
petitioner to affirmatively demonstrate a reasonable basis.” McKellar, 101 Fed. Cl. at 305.
The Vaccine Act “offers no further explanation or definition of what constitutes a
‘reasonable basis,’” and “neither the Federal Circuit nor the Court of Federal Claims has had
occasion to define the meaning of reasonable basis for purposes of fee awards under the Vaccine
Act.” Chuisano, 116 Fed. Cl. at 285 (internal quotations and citations omitted). “If a special
awarded, and the Fee Application itself. The amounts entered on the Fee Application’s
supporting documentation, Fee Application, Exs. 2, 11, and 13, will be used in addressing the
hours petitioners’ counsel spent on the appellate litigation at issue here. Where hours are
reported in hour and minute format, they will be converted to decimal form by dividing the total
number of minutes by 60. Thus, for example, in Ex. 2, at 8, Mr. McHugh reports a total of 140
minutes spent on the creation of the final Fee Application; this converts to 2.33 hours of time.
Fee Application, Ex. 2, at 8. Because of the differences between the billed time as reported in
the Attorneys’ Fee Decision and the Fee Application, the special master’s calculation of the
amounts requested differs from that of the court. The court uses the hours as stated by
petitioners’ counsel, with the monetary amounts restated accordingly.
Petitioners do not contest the special master’s determination as to petitioners’ counsels’
hourly rates, so the hourly rates as determined by the special master will be used for calculating
the total amounts petitioners seek. See Pet’rs’ Mot. at 6; Attorneys’ Fee Decision, slip op. at 7-8.
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master determines that there is good faith and a reasonable basis for a claim, ‘he or she may
award the fees’[,] . . . [but] [i]t is nevertheless possible that, after making the required findings of
good faith and reasonable basis, the special master may decline to award fees or costs.” Id. at
284-85 (internal citations omitted) (emphasis in original). Yet, no special master has found a
reasonable basis and denied fees. See Silva v. Secretary of Health & Human Servs., 108 Fed. Cl.
401, 405 (2012) (citing Silva v. Secretary of Health & Human Servs., 2012 WL 2890452, at *9 &
n.17 (Fed. Cl. Spec. Mstr. 2012) (“Special masters have implemented Congress’s goal of paying
attorneys by always awarding attorneys’ fees upon a finding of reasonable basis. Although
special masters have discretion not to award attorneys’ fees to unsuccessful petitioners whose
cases are supported by a reasonable basis, special masters have not exercised this discretion to
deny attorneys’ fees for cases supported by a reasonable basis.”)).
The reasonable-basis analysis is not a one-time inquiry. Accordingly, a petition that has a
reasonable basis at the time of filing may lose reasonable basis during the pendency of the case.
See Perreira v. Secretary of Health & Human Servs., 33 F.3d 1375, 1377 (Fed. Cir. 1994).
Several decisions have noted the possibility that appellate activity could be without reasonable
basis even where the underlying petition or prior stages of the overall proceeding had a
reasonable basis. See, e.g., Phillips v. Secretary of Health & Human Servs., 988 F.2d 111, 113
(Fed. Cir. 1993) (Plager, J., concurring) (“The appropriateness of an award of fees related to the
initial proceedings before the special master is an issue quite separate from the appropriateness
of fees attributable to an appeal to this court.”); Perreira v. Secretary of Health & Human Servs.,
27 Fed. Cl. 29, 33 (1992) (“[T]he special master . . . determined that, when the petition was filed,
it was brought in good faith and at that time there was a reasonable basis for a claim . . . [but
that] reasonable basis for the claim no longer existed after the specific point in time petitioners’
counsel knew, or should have known, their expert’s unsupported medical theory was legally
insufficient to establish causation in-fact.”), aff’d, 33 F.3d 1375.
Even though continuing to litigate a vaccine petition after circumstances change or more
information comes to light may not have a sustained reasonable basis, see Perreira, 27 Fed. Cl.
at 33, a litigating position does not lack a reasonable basis simply because it is ultimately
unavailing. Correspondingly, litigating issues of fact that are subject to the deferential arbitrary
and capricious standard on appeal is not per se without reasonable basis. See, e.g., Nuttall v.
Secretary of Health & Human Servs., 2017 WL 3205815, at *3 (Fed. Cl. Spec. Mstr., 2017)
(“Petitioner’s appeal before the Federal Circuit mainly involved factual issues[,] . . . which were
subject to an arbitrary and capricious standard of review[;] that alone does not render the appeal
per se unreasonable. The factual issues in this case . . . were very complex.”) (emphasis in
original). Additionally, the fact that an appeal is denied without opinion pursuant to Federal
Circuit Rule 36 does not necessarily mean that an appeal was without reasonable basis, let alone
per se frivolous. See Davis v. Secretary of Health & Human Servs., 105 Fed. Cl. 627, 636-37
(2012) (reversing a special master’s determination that a Rule 36 affirmance without opinion by
the Federal Circuit necessarily meant that the appeal lacked a reasonable basis or was frivolous,
pointing out that Federal Circuit precedent “cautions lower courts from reading too much into a
Rule 36 decision[ and] reject[s] the . . . argument that an affirmance without opinion always
mean[s] that the appeal was frivolous. . . . [Rather,] the only reliable inference from a Rule 36
disposition [i]s that the trial court’s explanation for its decision was clear and sound and no
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useful purpose would [be] served by [the Federal Circuit] writing an opinion.”) (internal
quotations and citations omitted).
B. Standard of Review of Fee Decisions
“Notably, a special master’s decision whether to award or deny attorneys’ fees and costs
to unsuccessful petitioners is discretionary and, thus, reviewed under an abuse of discretion
standard.” Chuisano, 116 Fed. Cl. at 283 (citing Saxton v. Secretary of Health & Human Servs.,
3 F.3d 1517, 1520 (Fed. Cir. 1993)) (additional citations omitted); accord, Silva, 108 Fed. Cl. at
405 (“A special master’s determination of attorneys’ fees and costs is entitled to deference. So
long as the special master has ‘considered the relevant evidence of record, drawn plausible
inferences, and stated a rational basis for the decision, reversible error is extremely difficult to
establish.”) (internal quotations, brackets, and citations omitted). An abuse of discretion exists
where “(1) the . . . decision is: clearly unreasonable, arbitrary, or fanciful; (2) . . . based on an
erroneous conclusion of the law; (3) . . . clearly erroneous; or (4) the record contains no evidence
on which the [special master] rationally could have based [his] decision.” Simmons, 875 F.3d at
635 (quoting Hendler v. United States, 952 F.2d 1364, 80 (Fed. Cir. 1991)).
ANALYSIS
Petitioners contest the special master’s rejection of attorneys’ fees for the hours
petitioners’ counsel billed for work before the Federal Circuit and the Supreme Court, arguing
that the special master abused his discretion because the chief reason given for why their appeal
lacked reasonable basis—that the Federal Circuit affirmed without opinion pursuant to Federal
Circuit Rule 36—was insufficient support for the conclusion that no reasonable basis existed.
See Pet’rs’ Mot. at 12; Attorneys’ Fee Decision, slip op. at 13. Respondent counters that the
special master did not abuse his discretion because he “rationally explained why he found
petitioners’ appellate activities to be unreasonable.” Resp’t’s Resp. at 5. As respondent frames
it, in their initial appeal, “[p]etitioners . . . proceeded to reargue the facts of the case . . . [and]
impl[ied] that the relief they sought was to have the Federal Circuit review their claim de novo,”
a position that respondent believes “patently lack[s] any merit.” Id. at 6.
The resolution of these countervailing contentions turns, then, upon consideration of what
arguments petitioners raised and when and whether the special master abused his discretion in
finding that the entire body of appellate activity was without reasonable basis. As will appear,
because the appeal to the Federal Circuit entailed different arguments from those presented in the
petitions for rehearing and rehearing en banc and the petition for certiorari, the two phases will
be considered separately.
A. Petitioners’ Appeal to the Federal Circuit
In their appeal to the Federal Circuit, petitioners focused on arguments that the special
master acted arbitrarily and capriciously in making crucial findings of fact, and they alluded only
briefly to the standard of review. See generally Pet’rs’ Appellate Brief. In connection with his
focus on the court of appeals’ affirmance without opinion under Federal Circuit Rule 36, the
special master commented only briefly on the factual arguments petitioners advanced in their
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appeal, stating that “[p]etitioners’ counsel expended a very large number of hours on re-stating
the facts of the case, and summarizing some aspects of past testimony by the medical experts.”
Attorneys’ Fee Decision, slip op. at 12-13. The special master also concluded that the appeal
was without reasonable basis because petitioners’ position regarding the standard of review ran
contrary to the “long-established” standard in Vaccine Act cases. As the special master put it, “if
that standard were changed . . . . [it] would have granted to every petitioner the right to receive
de novo determination by the Court of Appeals of every aspect, including factual findings, of
every Vaccine Act decision by a special master.” Id. (internal emphasis omitted). On this basis,
the special master concluded that the petitioners’ appeal “was legally meritless—so legally
dubious as to be, in essence, a frivolous argument.” Id. at 13 (emphasis in original).
Taken at face value, the Attorneys’ Fee Decision places great emphasis on petitioners’
cursory questioning of the standard of review applicable to the appeal, largely passing over
petitioners’ primary focus in the appeal on the complex issues of causation stemming from J.H.’s
severe neurological degeneration after she received of influenza vaccine. J.H.’s condition,
despite extensive testing and attempts at diagnosis at some of the foremost medical institutions in
the United States, has no known etiology. See Hirmiz, 119 Fed. Cl. at 211-15.
A challenge to findings of fact on appeal, even when subject to the deferential arbitrary
and capricious standard of review, can still have a reasonable basis, especially where the facts at
hand are “very complex.” Nuttall, 2017 WL 3205815, at *3 (emphasis in original). By giving
short shrift to the primary focus of the petitioners’ appeal to the Federal Circuit on the complex
factual bases for the special master’s Entitlement Decision, and instead finding their appeal
unreasonable and even frivolous because of a legal argument that they alluded to, but did not
elaborate, the special master’s decision is not well supported.
Additionally, the special master’s reliance on the Federal Circuit’s summary affirmance
under Federal Circuit Rule 36, see Attorneys’ Fee Decision, slip op. at 13, did not have the
significance that the special master attached to it. As this court observed in Davis, 105 Fed. Cl.
at 636-37, the only reliable inference to be drawn from such a disposition is that “the trial court’s
explanation for its decision was clear and sound and no useful purpose would have been served”
by an appellate decision. If the Federal Circuit had found the appeal frivolous, as the special
master seemed to believe, the Federal Circuit could have said as much, yet no such indication
was given. See Hirmiz, 618 Fed. Appx. 1033. In short, the weight the special master gave to the
Federal Circuit’s summary affirmance is misplaced for the reasons given in Davis.
Overall, because the special master’s reasoning as to why the appeal lacked reasonable
basis was inadequate to support his conclusion, the special master’s decision was unreasonable
and arbitrary. The court concludes that petitioners’ appeal to the Federal Circuit had a
reasonable basis and was filed in good faith, and thus that petitioners are entitled to receive an
award of attorneys’ fees for the legal work performed in furtherance of that appeal.
B. Petitioners’ Petitions for Rehearing and Petition for Certiorari
Contrastingly, petitioners’ submissions to the Federal Circuit in seeking rehearing and
rehearing en banc and to the Supreme Court in seeking certiorari abjured the factual arguments
they had previously made for overturning the Entitlement Decision, and instead rested wholly on
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the contention that a stringent standard of review should be applied based on Stern v. Marshall.
That argument had been made by petitioners in their appeal only in the most cursory fashion,
without citing Stern. That circumstance compromised any likelihood of success for the petition
for rehearing. The Federal Circuit has emphasized that “[o]ur law is well established that
arguments not raised in the opening brief are waived.” SmithKline Beecham Corp. v. Apotex
Corp., 439 F.3d 1312, 1319 (Fed. Cir. 2006); see also Anderson v. City of Boston, 375 F.3d 71,
91 (1st Cir. 2004) (“‘When a party includes no developed argumentation on a point . . . we treat
the argument as waived.’”); Tolbert v. Queens Coll., 242 F.3d 58, 75 (2d Cir. 2001) (“‘It is a
settled appellate rule that issues adverted to in a perfunctory manner, unaccompanied by some
effort at developed argumentation, are deemed waived.’”). In short, petitioners waived their
argument as to the standard of review by only “advert[ing] to [it] in a perfunctory manner” and
not appropriately briefing the issue in their appeal. Even though petitioners’ argument for a
stringent standard of review based on Stern was not itself frivolous, see Connell v. Sears,
Roebuck & Co., 722 F.2d 1542, 54 (Fed. Cir. 1983) (“[A]ppeals having a small chance of
success are not for that reason alone frivolous[; o]ne may legitimately argue, for example, that
even overwhelming contrary precedent should be overruled or distinguished.”), petitioners had
not presented that argument in a timely manner.6
Because petitioners waived the right to contest the standard of review before the Federal
Circuit by not adequately raising it in their appeal, it was unreasonable for them to seek
rehearing and rehearing en banc on that issue. Cf. Fed. Cir. R. 40(a)(4) (“The preferred
6The special master considered the argument about the standard of review to be so
meritless that he deemed it to be frivolous. Attorneys’ Fee Decision, slip op. at 13. As noted
earlier, see supra, at 3-4 n.3, a more developed version of this argument was presented to the
Federal Circuit in Milik. In that case, the Federal Circuit carefully weighed the merits of the
argument that the Constitution requires de novo review in an Article III court for claims covered
by the Vaccine Act, before ultimately concluding that this argument was unavailing. See Milik,
822 F.3d at 1374-80. The Federal Circuit analyzed the legislative history of the Vaccine Act,
relevant Supreme Court precedent, and the separation of powers and preemption doctrines. Id.
Further, after the Federal Circuit panel denied the petitioners’ appeal, the Miliks presented a
petition for rehearing and rehearing en banc. See Pet’n for Reh’g and Reh’g en banc, Milik v.
Secretary of Health & Human Servs., App. No. 15-5109, Doc. No. 30 (Fed. Cir. June 30, 2016).
In considering this petition, the Federal Circuit called for a response from the Secretary of Health
and Human Services, a discretionary request that almost certainly would not happen if the court
thought the question presented in the Miliks’ petition to be frivolous. See Invitation for Resp.,
Milik, App. No. 15-5109, Doc. No. 32 (July 18, 2016); cf. Fed. R. App. P. 35(e) (“No response
may be filed to a petition for an en banc consideration unless the court orders a response.”); Fed.
Cir. R. 35(e)(4) (“If the court requests a response . . .”) (emphasis added). Likewise, when the
petitioners submitted a petition for a writ of certiorari to the Supreme Court, the Secretary
initially waived a response, but the Court requested a response. See Brief for the Respondent,
Milik v. Price, 2017 WL 1488629 (U.S.). The extensive consideration that the Federal Circuit
and the Supreme Court gave to petitioners’ constitutional arguments in Milik undermines the
special master’s conclusion here that the argument over the applicable standard of review was
wholly without merit.
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contents . . . [of] a petition for panel rehearing [include:] . . . the points of law or fact overlooked
or misapprehended by the court.”); Fed. Cir. R. 28(a) (“Briefs . . . must contain[:] . . . the
statement of the issues; . . . [and] the argument, including statement of the standard of review.”).
Accordingly, because the petitions for rehearing and rehearing en banc raised only issues that
had been waived, those petitions lacked reasonable basis. Petitioners’ petition for a writ of
certiorari suffers from the same defect. Thus, petitioners’ request for an award of attorneys’ fees
for the legal work performed in petitioning for rehearing and for certiorari must be denied.
C. Dispositive Action on the Fee Application
When a special master has abused the discretion afforded by the Vaccine Act, this court
may, on petition for review, either “set aside any findings of fact or conclusion of law of the
special master found to be . . . an abuse of discretion . . . and issue its own findings of fact or
conclusions of law, or . . . remand the petition to the special master for further action.” 42
U.S.C. § 300aa-12(e)(2)(B)-(C); see also Althen v. Secretary of Health & Human Serv’s., 418
F.3d 1274, 1281 (Fed. Cir. 2005) (“[B]ecause the special master’s decision was [set aside under
§ 300aa-12(e)(2)(B)], the [Court of Federal Claims] was permitted to review the evidence anew
and come to its own conclusion.”); Doe v. Secretary of Health & Human Serv’s., 89 Fed. Cl.
661, 667 (2009) (citing “significant delays” and “lengthy and contentious proceedings” in
deciding to set aside an award of interim attorneys’ fees and issuing its own award rather than
remanding for further consideration by the special master). The court has considered whether it
is prudent to issue its own findings of fact and conclusions of law necessary to resolve this case
rather than remanding for further proceedings. Ordinarily, the court would remand, but special
circumstances apply here which indicate that the court should itself act.
This case has been pending a long time. The Hirmiz’ petition for compensation was filed
on May 8, 2006, and it is only now reaching a conclusion—over a decade later. See Pet’rs’ Pet.,
06-371V, ECF No. 1 (May 8, 2006). Over its pendency, petitioners’ case has thus far been heard
by two special masters—the special master who conducted the initial evidentiary hearing and the
special master who conducted the second evidentiary hearing and issued the Entitlement
Decision. Both have now retired from the Office of Special Masters. If this court opted to
remand this case for further consideration, it would have to be reassigned to a third special
master, and the parties would be required to re-litigate salient issues in this case to acquaint the
special master with the issues presented by the petitioners’ Fee Application. Rather than require
the parties to spend more time and money re-litigating key portions of the case, and because the
issue that petitioners request this to court decide is well-defined, “the court is well[-]situated to
spare both parties further litigation by making its own finding.” Davis, 105 Fed. Cl. at 637; see
also Phillips v. General Servs. Admin., 924 F.2d 1577, 1581 (Fed. Cir. 1991) (commenting that
the court was in “a better position . . . to determine the amount of fees and expenses” than the
Merit Systems Protection Board, in connection with a review of a decision of that Board). It is
significant that the court is already well acquainted with the case, having considered it in detail
on a motion for review of the special master’s Entitlement Decision. See generally Hirmiz, 119
Fed. Cl. 209.
Additionally, the record in this case enables this court to resolve the issue presented by
petitioners’ instant motion for review. See Althen, 418 F.3d at 1281 (“So long as the record
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contained sufficient evidence upon which to base predicate findings of fact and the ultimate
conclusion of [the issue on which the special master was overruled], the [Court of Federal
Claims] was not required to remand.”). The facts at issue and the arguments raised in
petitioners’ appeals have been well fleshed out and the parties have extensively briefed and
documented the issue of fees. Consequently, this court is well-situated to rule on the issue of
whether petitioners’ appeals had a reasonable basis.
In sum, regarding petitioners’ appeal to the Federal Circuit, the court finds that the
complex factual issues of causation that petitioners raised gave their appeal reasonable basis, and
the court concludes that petitioners are entitled to an award of attorneys’ fees for the work spent
litigating the appeal. As the Fee Application indicates, Mr. McHugh billed 166.35 hours and Mr.
Gaynor spent 3.1 hours on the appeal. Fee Application, Exs. 2, 11, 13. The special master
determined that the proper rate for Mr. McHugh’s time billed during 2015 (when the appeal to
the Federal Circuit was litigated) was $400 per hour, while the proper rate for Mr. Gaynor’s time
was $385. Attorneys’ Fee Decision at 16-17. At these rates, petitioners are awarded $66,540 for
Mr. McHugh’s legal work, and $1,193.50 for Mr. Gaynor’s legal work—a total of $67,733.50.
In contrast, the court finds that petitioners’ petitions for rehearing and for a writ of
certiorari were without reasonable basis because they abjured factual arguments and focused
only on arguing for a stringent standard of review, an argument that, as considered above, was
waived. Thus, the court finds that petitioners are not entitled to an award of attorneys’ fees for
any hours billed on the petitions for rehearing and for certiorari.
CONCLUSION
For the reasons stated, the motion for review of the special master’s Attorneys’ Fee
Decision is GRANTED IN PART and DENIED IN PART. The Attorneys’ Fee Decision is in
part REVERSED and in part AFFIRMED. Petitioners shall receive attorneys’ fees for the legal
work performed on their appeal to the Federal Circuit, in the amount of $67,733.50, but not for
the work on the petitions for rehearing and for certiorari. The amount of $67,733.50 shall be
added to the award by the special master of $121,906.00 for attorneys’ fees and costs, and
$991.00 for petitioners’ own litigation expense—for an overall total of $190,630.50. The clerk
shall enter judgment accordingly.
It is so ORDERED.
s/ Charles F. Lettow
Charles F. Lettow
Judge
11