VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_10-vv-00809
Package ID: USCOURTS-cofc-1_10-vv-00809
Petitioner: S.W.
Filed: 2010-11-22
Decided: 2015-12-01
Vaccine: DTaP
Vaccination date: 2007-11-26
Condition: transverse myelitis
Outcome: compensated
Award amount USD: 160971.12

AI-assisted case summary:
On November 22, 2010, Rebecca and Randall Whitney filed a petition under the National Childhood Vaccine Injury Compensation Program on behalf of their son, S.W., alleging that vaccines administered on November 26, 2007, at approximately four months of age, caused him to develop transverse myelitis. The vaccines administered were DTaP, Hib, IPV, pneumococcal conjugate, and rotavirus. S.W. had been healthy in his first months of life, though he experienced a mild upper respiratory infection around Thanksgiving 2007, which experts later associated with human herpesvirus 6 (HHV-6). In early December 2007, S.W. developed congestion and bowel changes, which experts considered early neurologic signs. By December 12, 2007, his legs were weak, and on December 13, 2007, his mother took him to the pediatrician due to his lack of normal movement and screaming when moved. Examination revealed decreased tone in his lower extremities, clonus, and absent reflexes. Hospital testing indicated inflammation in the spinal cord, and MRI findings in the cervical and thoracic spine were interpreted as possible immune-mediated disseminated myelitis. His brain and lumbosacral spine imaging were normal. Treating doctors considered possible infectious triggers, post-vaccination reaction, and autoimmune disease. S.W. received high-dose steroids and was transferred to rehabilitation. His residual problems included paraplegia, need for mobility supports, speech delays, fatigue, and bowel/bladder issues.

Special Master Christian J. Moran initially denied compensation on May 8, 2015, finding that while petitioners presented a plausible medical theory and acceptable timing, they failed to prove a logical sequence of cause and effect, giving greater weight to treating record references suggesting HHV-6 as the cause. On review, Judge Charles F. Lettow vacated this decision and remanded the case on August 12, 2015. The court held that the special master had drawn unsupported inferences, discounted records listing vaccination as a possible cause, and over-credited a later report attributing the condition to HHV-6.

Following remand, the respondent continued to deny that the vaccines caused S.W.'s transverse myelitis. However, the parties resolved the case by stipulation. On December 1, 2015, Special Master Christian J. Moran adopted the settlement. The award included a lump sum of $150,000.00 for S.W.'s benefit, $10,971.12 to satisfy a State of Michigan Medicaid lien, and an additional amount sufficient to purchase an annuity contract as described in the stipulation. Petitioners were represented by Ronald C. Homer of Conway, Homer & Chin-Caplan, P.C. Respondent was represented by Lara A. Englund of the U.S. Department of Justice.

Theory of causation field:
Petitioners Rebecca and Randall Whitney alleged that S.W., a minor, received DTaP, Hib, IPV, pneumococcal conjugate, and rotavirus vaccines on November 26, 2007, at approximately four months of age, and subsequently developed transverse myelitis. The alleged injury manifested with symptoms including congestion, bowel changes, and leg weakness starting around December 6, 2007, with hospitalization on December 13, 2007, showing spinal cord inflammation and MRI findings suggestive of immune-mediated disseminated myelitis. Petitioners' expert, Dr. Yuval Shafrir, supported vaccine causation and disputed HHV-6 as the cause. Respondent's experts, including Dr. Max Wiznitzer and Dr. James Oleske, proposed HHV-6 as an alternative trigger. Initially, Special Master Christian J. Moran denied compensation on May 8, 2015, finding a failure to prove a logical sequence of cause and effect. On August 12, 2015, Judge Charles F. Lettow vacated this decision and remanded the case, citing unsupported inferences and mischaracterization of medical records. The parties subsequently resolved the case by stipulation, and on December 1, 2015, Special Master Moran adopted the settlement, awarding $150,000.00 for S.W.'s benefit, $10,971.12 for a Medicaid lien, and an amount for an annuity. Petitioners were represented by Ronald C. Homer, and respondent by Lara A. Englund.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_10-vv-00809-0
Date issued/filed: 2015-07-28
Pages: 22
Docket text: PUBLIC DECISION (Originally filed: 05/08/2015) regarding 111 DECISION of Special Master. Signed by Special Master Christian J. Moran. (tpj) Copy to parties.
--------------------------------------------------------------------------------
Case 1:10-vv-00809-CFL Document 124 Filed 07/28/15 Page 1 of 22
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
REBECCA WHITNEY and *
RANDALL WHITNEY, parents of * No. 10-809V
S.W., a minor, * Special Master Christian J. Moran
*
Petitioners, * Filed: May 8, 2015
* Reissued: July 20, 2015
v. *
* Entitlement; diphtheria-tetanus
SECRETARY OF HEALTH * acellular pertussis (DTaP) vaccine;
AND HUMAN SERVICES, * transverse myelitis; burden shifting;
* human herpesvirus (HHV-6).
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Ronald C. Homer, Conway, Homer & Chin-Caplan, P.C., Boston, MA, for
Petitioners;
Lara A. Englund, U. S. Dep’t of Justice, Washington, DC, for Respondent.
PUBLISHED DECISION DENYING COMPENSATION1
Rebecca and Randall Whitney allege that one of the vaccines given to their
son, S.W., when he was approximately four-months old caused him to develop a
severe neurologic problem, transverse myelitis. They seek compensation pursuant
to the National Childhood Vaccine Injury Compensation Program, codified at 42
U.S.C. § 300aa–10 through 34 (2012).
Although the Whitneys have presented a plausible claim, S.W.’s treating
doctors have not agreed with the allegation that the vaccinations caused S.W.’s
transverse myelitis. Because the Federal Circuit has instructed special masters to
consider the opinions of treating doctors with great care, the most persuasive
1 The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,
2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b),
the parties have 14 days to file a motion proposing redaction of medical information or other
information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special
master will appear in the document posted on the website.

Case 1:10-vv-00809-CFL Document 124 Filed 07/28/15 Page 2 of 22
evidence is against the Whitneys’ claim. Thus, they are not entitled to
compensation.
Facts
S.W. was born on [redacted] 2007. Exhibit 1 at 1. He has an older sister
and an older brother, who were 7 and 3 years old, respectively, when he was born.
Exhibit 13 at 1. For approximately the first four months of life, S.W. was healthy
and did not present any problems with development or illness to his pediatrician.
See exhibit 13 at 1-7.
In mid-November 2007, S.W. had a mild upper respiratory infection. The
rest of S.W.’s family had similar symptoms. Exhibit 2 at 264.2 The Whitneys did
not bring S.W. to his pediatrician for this illness. See exhibit 13. Evidence
adduced from the records and at hearing established that S.W.’s illness was
probably a manifestation of an infection with human herpesvirus 6 (HHV-6). Tr.
493.3
2 The medical records are not very precise about when S.W. had symptoms of an upper
respiratory illness. A December 13, 2007 report states that he had a running nose and a cough
“about one month ago.” Exhibit 2 at 253. Another report, which was created on December 14,
2007, states that Ms. Whitney recalled an upper respiratory infection “about 4 weeks ago near
Thanksgiving.” Id. at 264.
The parties agreed that the precise date of S.W.’s illness around Thanksgiving is not a
material fact. Pet’rs’ Resp., filed Jan. 30, 2015, at 1-5; Resp’t’s Memorandum, filed Jan. 30,
2015, at 1.
3 The finding that S.W. probably suffered from an HHV-6 infection around Thanksgiving
2007 is an inference drawn from several facts. First, S.W. is very unlikely to have become
infected with HHV-6 before November 2007, because antibodies that he inherited from his
mother protected him until the maternal antibodies faded. Tr. 356-60; see also exhibit A, tab 1
(Danielle M. Zerr et al., A Population-Based Study of Primary Human Herpesvirus 6 Infection,
352 N. Engl. J. Med. 768) at 772 (showing incidence of HHV-6 infections). Second, as
discussed below, S.W. tested positive for HHV-6 on December 14, 2007. The specific values
suggested that S.W. was in the convalescent stage of the HHV infection, meaning that he had
recently been infected but was recovering from the infection. Tr. 495-501 (Dr. Wientzen); see
also Tr. 339-42, 593-96 (Dr. Oleske: “the points [Dr. Wientzen] made about latent infection and
convalescence in recovery phase, I would agree with”). Thus, it is probable --- although not
certain --- that S.W.’s mild illness around Thanksgiving was actually HHV-6. See Tr. 363 (Dr.
Oleske: “it’s reasonable to say he acquired [the HHV-6 infection] somewhere around a month or
two – a month of age, when he had that . . . mild URI”), 493 (Dr. Wientzen: “I think he had an
active HHV-6 infection at about Thanksgiving”).
2

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On November 26, 2007, S.W. saw his pediatrician for his four-month well
baby visit. The notes associated with this visit are relatively sparse. They indicate
that S.W. was not sleeping well, had normal elimination, and displayed a good
temperament. Exhibit 13 at 5; exhibit 1 at 1. For other concerns, the pediatrician
recorded none. Id. At this appointment, S.W. received a set of vaccinations: his
second doses of the diphtheria-tetanus-acellular pertussis (“DTaP”), haemophilus
influenzae B, inactivated polio virus, pneumococcal conjugate, and rotavirus
vaccines. Id.
On approximately December 6, 2007, S.W. had “some congestion and upper
respiratory symptoms. . . but no fevers. No nausea, vomiting, diarrhea.” Exhibit 2
at 261. Also around December 6, 2007, S.W. “appeared to be straining whenever
he stooled.” Exhibit 2 at 253. The testifying experts opined that the change in
S.W.’s bowel habits indicated he was starting to have neurologic problems. Tr.
160 (Dr. Shafrir), 280 (Dr. Wiznitzer); see also Tr. 361 (Dr. Oleske).
On December 12, 2007, S.W.’s legs were weak. He did not sleep well that
night. Exhibit 2 at 253; exhibit 14 (Ms. Whitney’s affidavit) at 2, ¶5.
S.W.’s problems continued into the next day, December 13, 2007. His
mother brought him to the pediatrician’s office and reported that S.W. was not
moving for two days and screaming when waking up or moving his legs. The
doctor’s examination showed that S.W. had a decreased tone in his lower
extremities, “some clonus,” and absent reflexes.4 The doctor admitted S.W. to the
hospital. Exhibit 1 at 46. The presence of clonus means that S.W. began suffering
from neurologic problems 7-10 days earlier. Tr. 33, 65, 194.
In the emergency room, the doctor obtained a history similar to that
presented above. The doctors obtained blood samples to conduct laboratory tests,
consulted a neurologist, and performed a lumbar puncture. S.W. was sent to the
pediatric intensive care unit. Exhibit 2 at 261. The cerebrospinal fluid showed
inflammation in the spinal cord. Id. at 254; Tr. 96, 160.
Upon admission, Ms. Whitney provided another history which, although
more detailed, was consistent with the previously provided histories. The doctors
4 The term “clonus” is defined as “alternative muscular contraction and relaxation in
rapid succession,” and “a continuous rhythmic reflex tremor initiated by the spinal cord below an
area of spinal cord injury, set in motion by reflex testing.” Dorland’s Illustrated Medical
Dictionary 373 (32d ed. 2012).
3

Case 1:10-vv-00809-CFL Document 124 Filed 07/28/15 Page 4 of 22
ordered a series of MRIs and prescribed Rocephin. Exhibit 2 at 253-55. Rocephin
could kill bacteria infecting S.W. Tr. 97, 161, 209.
Before S.W. had his MRIs, a neurologist, Steven DeRoos, saw him. Dr.
DeRoos recorded another history of S.W.’s illness.5 For social history, Dr.
DeRoos stated “[n]o acute febrile illness recently.” Dr. DeRoos examined S.W.
His plan was to obtain the MRIs and a CT scan of the spine. Dr. DeRoos “agree[d]
with the IV antibiotics until more information is known.” Exhibit 2 at 267.
S.W. had four MRIs on December 13, 2007. The images for S.W.’s brain
and lumbosacral spine were normal. However, the images for S.W.’s cervical
spine and thoracic spine showed damage in his spine. Exhibit 2 at 249-52. The
radiologist interpreting the images stated that the abnormal signaling may represent
“an immune mediated disseminated myelitis, perhaps parainfectious in etiology.”
Exhibit 2 at 250.
On December 14, 2007, George Fogg, a specialist in pediatric infectious
diseases, saw S.W. Dr. Fogg received another history and noted that S.W. “had his
4-month immunizations on 11/26/07, [which] included DTaP.” Exhibit 2 at 264.
Dr. Fogg stated that S.W.’s presentation was “consistent with acute disseminated
encephalomyelitis (ADEM).” Id. at 265. With respect to potential causes, Dr.
Fogg listed: “possible infectious triggers include viral (CMV, EBV, HSV,
enterovirus and West Nile), bacterial (Campylobacter, and mycoplasma), post
vaccination reaction, or autoimmune disease.” Id. Dr. Fogg made 10
recommendations. Id. at 265-66. Significant requests include polymerase chain
reaction (PCR) testing on S.W.’s blood for various organisms including HHV-6,
and an “ANA screen for autoimmune causes.” Id. Dr. Fogg stated that he “will
report the possible post immunization adverse event to the vaccine adverse event
reporting system (VAERS).” Id. Finally, Dr. Fogg also agreed with “the plans for
high-dose steroid therapy as directed by pediatric neurology.” Id.
An ANA test is helpful in detecting the presence of various autoimmune
diseases. Kathleen Deska Pagana and Timothy J. Pagana, Mosby’s Manual of
Diagnostic and Laboratory Tests 90-93 (4th ed. 2010); Tr. 109, but see Tr. 270.
S.W.’s ANA screen was negative (0.1 with an equivocal result being 1.0 – 1.4).
Exhibit 2 at 239.
5 Dr. DeRoos’s report stated that S.W. “had an MRI approximately 4 weeks ago.”
Exhibit 2 at 266. The reference to an “MRI” is almost certainly a typographical error and “URI,”
meaning upper respiratory infection, was probably intended.
4

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The test that Dr. Fogg ordered for HHV-6 was conducted on plasma. The
result showed 4,100 units. Exhibit 2 at 234.6 The pediatric neurologists who cared
for him in the hospital indicated that S.W. had “HHV 6 myelitis.” Exhibit 2 at 186
(report dated December 21, 2007); accord id. at 183 (report from pediatric service
dated December 20, 2007). All the experts testified about these records. Tr. 118
(Dr. Shafrir), 163 and 271 (Dr. Wiznitzer), 435 (Dr. Oleske), 474 (Dr. Wientzen).
On December 18, 2007, S.W. transferred out of the pediatric intensive care
unit. Exhibit 2 at 273. He remained in the same hospital until December 21, 2007,
when he was transferred to a rehabilitation hospital, Mary Free Bed Hospital.
Exhibit 2 at 271.7 He stayed in the rehabilitation hospital until January 2, 2008.
Exhibit 5 at 47.
S.W. had a follow-up appointment at a neurology clinic on February 13,
2008. A family nurse practitioner, Kim Shelanskey, described that an MRI showed
an abnormal signal from the C2–C3 level to the upper thoracic spine. Ms.
Shelanskey stated “[t]his was thought to be a form of myelopathy.” Continuing,
she explained that “Infectious Disease was able to identify the HHV-6 virus as the
causative agent.”8 Ms. Shelanskey reported that S.W. was “making nice gains and
continues to work with both occupational therapy and physical therapy.” Dr.
DeRoos, the neurologist, agreed with this assessment. Exhibit 6 at 44-45; see also
exhibit 5 at 330-33; Tr. 121. Unfortunately, as noted below, S.W.’s improvement
was not complete.
S.W. saw a urologist, Brian Roelof, on February 19, 2008. In the context of
presenting S.W.’s history, Dr. Roelof indicated that Ms. Whitney “states that they
6 The testifying doctors disputed whether S.W.’s treating doctors responded appropriately
to the positive PCR test. Tr. 102 and 149-53 (Dr. Shafrir), 192-94, 210, and 257-58 (Dr.
Wiznitzer), 325-27, 432-35, and 449 (Dr. Oleske). However, this issue is extraneous to
determining whether the vaccines caused S.W.’s transverse myelitis.
7 At the time of both transfers, doctors listed S.W.’s diagnosis as ADEM. However,
another doctor (Adam Rush) disagreed with the diagnosis of ADEM because S.W.’s problem
was limited to his spine and did not affect his brain. Exhibit 5 at 328. Both testifying
neurologists have agreed with the diagnosis of transverse myelitis. See exhibit 16 at 7 (Dr.
Shafrir: “[t]here is no ‘encephalo’ involvement”); Tr. 198 (Dr. Wiznitzer).
8 Dr. Shafrir testified that the reports from the specialist in infectious diseases, Dr. Fogg,
did not actually identify HHV-6 as the infectious agent. Dr. Fogg’s report listed several possible
causes (exhibit 2 at 264-66), but he did not narrow down this list in a written report. Tr. 27-28,
272.
5

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thought he had acute viral myelitis secondary to a virus or perhaps from his
vaccinations.” Dr. Roelof did not otherwise comment on possible causes for his
viral myelitis. Exhibit 4 at 17.
Adam Rush, the doctor who cared for S.W. during his rehabilitation in Mary
Free Bed Hospital, saw S.W. on February 22, 2008. Mr. and Ms. Whitney
informed him that S.W. was having a “dramatic return of strength and apparent
sensation in his bilateral[] lower limbs.” S.W.’s parents also told Dr. Rush that
they were “not planning at this time for him to receive any more immunizations.”
Dr. Rush anticipated seeing S.W. back in six months.
Dr. Rush extensively commented upon S.W.’s missing of his scheduled six-
month immunization. Dr. Rush wrote:
Finally, as regards immunization noncompliance, I failed
today to address this issue with his parents, which I
regret. It is incredibly important like any other child, he
get his immunizations. I can only surmise at this point
his parents are reluctant give him immunizations in the
misguided belief that the immunizations were the cause
of his myelitis. I do not have any reason to believe this is
the case, nor do I believe literature would [bear] that out.
He should get all his immunizations.
Exhibit 5 at 328; see also Tr. 123, 274.
When Dr. Rush next saw S.W., on June 4, 2008, he returned to “the issue of
immunizations again with S.W.’s mother.” He recorded that Ms. Whitney “clearly
feels very strongly at this point against resuming them now, though she did seem to
leave the door open for his receiving his immunizations at some point in the
future.”9 Id. at 325-26.
S.W. returned to see Dr. DeRoos, his neurologist, on September 15, 2008.
The Whitney’s reported that S.W. had had two spells over the last few weeks. Dr.
DeRoos did not know whether they had any significance. Exhibit 5 at 319-20.
9 A note from 2012 indicated that Ms. Whitney was refusing vaccinations for S.W.
Exhibit 24 at 177.
6

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About 13 months after S.W. was hospitalized, he had a repeat set of MRIs
performed. These were “unremarkable… with resolution of abnormal cord signal
previously seen on the study of 12/13/2007.” Exhibit 6 at 53 (report dated January
12, 2009).
S.W. had a somatosensory evoked potential test on July 13, 2009. The result
was abnormal, but S.W.’s axonal integrity remained. Exhibit 6 at 59.
On June 23, 2010, which was approximately two and one half years after
S.W.’s episode of acute transverse myelitis, he saw Lawrence C. Vogel, a
pediatrician. The appointment appears to be for routine follow-up, as the Whitneys
did not complain about any recent health troubles for S.W. In the context of
reviewing S.W.’s medical history, Dr. Vogel recounted events when he was almost
five months old. Dr. Vogel stated “apparently herpes virus 6 [was] isolated in the
cerebral spinal fluid but whether or not this was related to that or immunizations
has never been clarified.”10 Dr. Vogel also summarized the extent of S.W.’s
current treatments and therapies. He concluded with recommendations for follow-
up studies. Exhibit 8 at 2-4.
A licensed occupational therapist, Karen Gora, saw S.W. at Mary Free Bed
Rehabilitation Hospital on July 2, 2010. The purpose was to evaluate S.W.’s
mobility, seating, and ability to transfer. The ensuing letter of medical necessity
begins with a caption that states S.W.’s diagnosis is “Paraplegia, Myelitis
(Reaction to an Immunization at age 4 months).” Dr. Rush concurred with Ms.
Goya’s recommendations. Exhibit 5 at 380-83.11
More recently, S.W. started school in fall 2013. He becomes fatigued easily
while in school. Also, S.W. is having difficulty in learning (losing some of his
sight words and not making progress in math). He has speech delays, uses a
wheelchair or crutches, and wears diapers. Exhibit 22 at 3 (Dr. DeRoos’s report,
dated Dec. 5, 2013).
10 Dr. Shafrir stated that Dr. Vogel’s history incorrectly locates the HHV-6 virus in
S.W.’s cerebrospinal fluid. Tr. 148, 164-65. The actual source was plasma.
11 Although this form is captioned “Reaction to an Immunization,” it is very unlikely that
Dr. Rush changed his assessment of the cause of S.W. transverse myelitis. Both neurologists
testified that in practice, neurologists spend little time reviewing the precise wording of a form.
Tr. 126-28, 164-65, 274.
7

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Procedural History
The Whitneys began this case representing themselves, filing a pro se
petition on November 22, 2010. They did not file any of the documents, such as
medical records or affidavits, listed in 42 U.S.C. § 300aa–11(c)(2).
The case remained undeveloped until Mr. Ronald Homer became counsel of
record. Through their attorney, in March 2011, the Whitneys requested
authorization to subpoena medical records. They started filing medical records in
August 2011. On March 20, 2012, the Whitneys filed an amended petition,
reflecting the accumulation of information about S.W. The Whitneys alleged that
the DTaP vaccine caused S.W. to suffer ADEM. Am. Pet. at 1, 15.
The Secretary reviewed this material and advised that the information did
not support an award of compensation. The Secretary presented two reasons.
First, the Secretary argued that the Whitneys did not submit either a medical record
from a treating doctor saying that the vaccines caused S.W.’s neurological problem
or a report from a specially retained expert opining about causation. Second, the
Secretary also maintained that S.W.’s treating doctors “attributed his condition to
an HHV-6 infection.” Resp’t’s Rep. at 6 (citing exhibit 2 at 182, 186, 234). Thus,
the Secretary maintained that compensation was not appropriate.
In the status conference held after the Secretary filed her report, the
Whitneys stated that they planned to retain an expert. They were instructed to have
their expert address whether HHV-6 caused S.W.’s problem. The Whitneys
requested (and were granted) 60 days to obtain the expert’s report. Order, issued
June 13, 2012.
Approximately eight months later, the Whitneys filed a report from Yuval
Shafrir, a pediatric neurologist. Dr. Shafrir summarized S.W.’s medical records,
stated that S.W. suffered from transverse myelitis (not ADEM), concluded that the
DTaP vaccine caused the transverse myelitis, and ruled out HHV-6 as the cause of
the transverse myelitis. Exhibit 16. The Whitneys filed his curriculum vitae, and,
as tabs to his report, 26 articles Dr. Shafrir cited.
The Secretary requested (and was granted) 90 days to respond. After a
single (7 day) enlargement of time, the Secretary filed the reports, curricula vitae,
and cited literature from two doctors, Raoul Wientzen and Max Wiznitzer.
Dr. Wientzen brought the perspective of specialist in pediatric infectious
diseases. His report recounted S.W.’s history briefly, countered Dr. Shafrir’s
8

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opinion that the DTaP vaccine can cause transverse myelitis by discussing many of
the articles Dr. Shafrir cited, and asserted that the HHV-6 infection caused S.W.’s
transverse myelitis. Exhibit A.
Dr. Wiznitzer’s report was similar to Dr. Wientzen’s report. After a
summary of the medical records that show S.W. suffered from transverse myelitis,
Dr. Wiznitzer stated S.W.’s “transverse myelitis was caused by the acute infection
that preceded its onset.” Exhibit C at 7. He also argued that the proposition that
the DTaP vaccine can cause transverse myelitis “is not supported.” Id. at 8.
In the next status conference, the Whitneys stated that they were exploring
retaining another expert to address the HHV-6 infection. During a status
conference on August 22, 2013, the Whitneys disclosed that they retained James
Oleske, a specialist in immunology and pediatric infectious diseases, to opine
about HHV-6 infection.
Dr. Oleske’s first report was approximately two pages. It mainly addressed
the HHV-6 infection. Dr. Oleske stated that “I do not believe HHV-6 had any
causal relationship to [S.W.’s] neurologic diagnosis.” However, in passing, Dr.
Oleske also asserted that S.W.’s “illness represented an adverse reaction to the
second of his childhood immunizations that was administered seventeen days prior
to the onset of his illness and subsequent disabilities.” Exhibit 18 at 4.
The parties began to seek mutually convenient dates for a hearing. In
conjunction with this process, the parties were ordered to file briefs before the
hearing. Prehr’g Order, issued Nov. 21, 2013. This order noted that petitioners
had not disclosed any basis for Dr. Oleske’s opinion that the vaccinations caused
S.W.’s transverse myelitis. Id. at 5 n.3, 7 n.4. Thus, a status conference was held
to discuss the scope of Dr. Oleske’s anticipated testimony. The Whitneys stated
that they would explore the topic with Dr. Oleske, and, if necessary, file another
opinion.
The Whitneys filed a three-page supplemental report from Dr. Oleske
(exhibit 20). Approximately one-third of Dr. Oleske’s supplemental report is an
extensive quotation taken, without attribution, from an article filed as exhibit 20,
tab F. (Daniel Zagury et al., Toward a new generation of vaccines: the anti-
cytokine therapeutic vaccines, 98(14) Proc. Nat’l Acad. Sci. USA 8024 (2001)).
Dr. Oleske proposed that the vaccinations led to a production of cytokines and
cytokines led to transverse myelitis. Dr. Oleske cited seven articles, of which Dr.
Oleske co-authored five between 1977 and 1989. In a status conference, the
9

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Whitneys represented that Dr. Oleske was primarily relying upon the 2001 article
from the National Academy of Science. Order, issued Jan. 14, 2014.
Both parties filed briefs before the hearing. The parties’ factual
presentations showed that they agreed about the basic chronology of events. The
parties also agreed that S.W. suffered from transverse myelitis. Compare Pet’rs’
Prehr’g Br., filed Jan. 8, 2014, at 2-15, with Resp’t’s Prehr’g Br., filed Jan. 29,
2014, at 2-3.
The parties, however, differed in their assertions about the cause of S.W.’s
transverse myelitis. The Whitneys stated that the vaccinations were the cause and
they relied upon Dr. Shafrir and Dr. Oleske. The Secretary stated that HHV-6 was
the cause and she relied upon Dr. Wientzen and Dr. Wiznitzer.12
The four doctors testified at the hearing, conducted in two separate sessions.
On February 27, 2014, Dr. Shafrir and Dr. Wiznitzer testified. On March 7, 2014,
Dr. Oleske and Dr. Wientzen testified.
Following the hearing, the parties filed an initial set of briefs. In response to
an order, the parties also filed supplemental briefs. After the parties reported that
they could not resolve the case despite a final attempt at settlement, they submitted
the case for adjudication.
Standards for Adjudication
Petitioners are required to establish their cases by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of
Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379-80
(Fed. Cir. 2009) (reversing special master’s decision that petitioners were not
12 Neither party presented any evidence that the vaccinations acted in conjunction with
the HHV-6.
10

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entitled to compensation); see also Lampe v. Sec’y of Health & Human Servs., 219
F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Human Servs., 9 F.3d
958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge’s contention that the
special master confused preponderance of the evidence with medical certainty).
The elements of the Whitneys’ case are set forth in the often cited passage
from the Federal Circuit’s decision in Althen: “(1) a medical theory causally
connecting the vaccination and the injury; (2) a logical sequence of cause and
effect showing that the vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination and injury.” Althen v.
Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
Analysis
The three prongs of the Althen test are evaluated in separate sections below.
The order of presentation begins with timing because that topic is easiest. The next
issue is the theory and the last factor is the “logical sequence of cause and effect.”
Following the three Althen prongs, there is a brief discussion of factors unrelated.
A. Timing
Although timing is the last prong in Althen, timing can be assessed with
relatively few words at the beginning of the analysis. As part of their case-in-
chief, the petitioners bear the burden of establishing that the onset of the disease
occurred within an acceptable time. Bazan v. Sec’y of Health & Human Servs.,
539 F.3d 1347, 1352 (Fed. Cir. 2008).
Here, the Whitneys meet their burden. S.W. received his immunization on
November 26, 2007. Exhibit 1 at 1. He started developing neurologic problems
between seven and ten days before his pediatric visit on December 13, 2007. Tr.
33, 65, 194. The experts on both sides agreed that this latency (approximately
seven to ten days) was an appropriate amount of time for the vaccination to initiate
a series of steps leading to transverse myelitis. Tr. 90 (Dr. Shafrir), 196 (Dr.
Wiznitzer), 337 (Dr. Oleske), 575 (Dr. Wientzen).
The finding that the Whitneys established that S.W.’s transverse myelitis
started within an appropriate time after his vaccination does not end the inquiry
because “[t]emporal association is not sufficient, however, to establish causation in
fact.” Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir.
1992). The Whitneys must also establish two other prongs from Althen. See
Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355, 1364 (Fed. Cir. 2012)
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(holding that special master did not err in resolving a case based upon the second
prong of the Althen test); Paterek v. Sec’y of Health & Human Servs., 527 Fed.
Appx. 875, 881 (Fed. Cir. 2013) (stating “[t]o resolve this appeal, we only need to
address the second prong under Althen”).
B. Theory
Pursuant to Althen, the Whitneys have the burden to present “a medical
theory causally connecting the vaccination and the injury.” Althen, 418 F.3d at
1278. Here, the Whitneys’ experts, Dr. Shafrir and Dr. Oleske, attempt to connect
the DTaP vaccine to what is known about transverse myelitis.
Very little is known about the cause of transverse myelitis. Dr. Oleske went
so far as to say that the cause is not known. Tr. 409. One factor that contributes to
the dearth of information about the etiology of transverse myelitis is the rarity of
the disease. Tr. 14. Only about one person per million people suffers from
transverse myelitis. Tr. 61, 185. Consistent with this frequency, the testifying
neurologists have treated only a few patients with the disease. Tr. 14 (Dr. Shafrir:
less than 5), 158 (Dr. Wiznitzer: less than 10).
In approximately two-thirds of transverse myelitis cases, an infection or
immunization precedes the onset of spinal cord inflammation. Tr. 16, 510; exhibit
16, tab G (F.S. Pidcock et al., Acute transverse myelitis in childhood: center-based
analysis of 47 cases, 68(18) Neurology 1474 (2007)) at 1476. In the remaining
one-third of the cases, the doctors have not identified any potential causes. These
cases are sometimes labeled idiopathic. Tr. 147, 584; see also Dorland’s at 912.
Due to the antecedent infection in many transverse myelitis cases, doctors
have proposed two broad ideas. Doctors believe that an infectious agent (a
bacterium or a virus) can invade the spinal cord, causing inflammation. Tr. 159
(Dr. Wiznitzer); see also Tr. 68, 149, 289 (Dr. Shafrir discussing whether HHV-6
caused “viral myelitis” in S.W.). For S.W., little evidence supports a direct
invasion theory. Tr. 197-99 (Dr. Wiznitzer), 490 and 508 (Dr. Wientzen); Resp’t’s
Mem., filed Jan. 30, 2015, at 2.
When an infection outside of the spinal cord precedes the onset of transverse
myelitis, doctors believe that the infection leads to transverse myelitis via an
autoimmune process. Tr. 10 (Dr. Shafrir), 217 (Dr. Wiznitzer), 500 (Dr.
Wientzen). The term “autoimmune” means the body attacks itself. Tr. 509. The
autoimmune process itself is largely not understood. Potential mechanisms include
molecular mimicry, epitope spreading, and bystander activation. Tr. 16 (Dr.
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Shafrir), 217 and 282 (Dr. Wiznitzer); exhibit 16, tab D (N. Agmon-Levin et al.,
Transverse myelitis and vaccines: a multi-analysis, 18 Lupus 1198 (2009)) at 1201.
Assuming that one or more of these methods explain how an infection can
cause transverse myelitis, the next question is whether vaccines can incite the same
process. Dr. Wientzen testified: “I think all three of these pathophysiologic
approaches would apply equally to vaccine as to infection.” Tr. 570.13 Dr. Shafrir
and Dr. Oleske agreed. Tr. 16 and 64 (Dr. Shafrir), 336 (Dr. Oleske). However
Dr. Wiznitzer disagreed. Tr. 212, 236.
Given this evidence, it is relatively easy to find that the Whitneys have
presented a plausible medical theory to explain how a vaccine can cause transverse
myelitis. Whether this evidence rises to a preponderant level is a more difficult
question.14 For purposes of this decision, it is assumed that the petitioners meet
their burden of proof for Althen prong 1. This assumption can be made because
the evidence regarding prong 2 is decisive.
C. Logical Sequence of Cause and Effect
Because the Whitneys have met their burden of proof regarding prong 3 and
they are assumed to have met their burden of proof regarding prong 1, a critical
issue to resolving this case is whether they have met their burden of proof
regarding prong 2. The Federal Circuit has recognized that the second Althen
prong may be crucial: “A claimant could satisfy the first and third prongs without
satisfying the second prong when medical records and medical opinions do not
suggest that the vaccine caused the injury, or where the probability of coincidence
or another cause prevents the claimant from proving that the vaccine caused the
injury by preponderant evidence.” Capizzano v. Sec’y of Health & Human Servs.,
440 F.3d 1317, 1327 (Fed. Cir. 2006). If the Whitneys establish all three Althen
prongs, then the burden of proof would shift to the Secretary to establish a factor
unrelated to the vaccinations caused the transverse myelitis. Althen, 418 F.3d at
1278.
13 Although Dr. Wientzen opined that the mechanisms by which HHV-6 could cause
transverse myelitis are mechanisms by which the DTaP vaccine could cause transverse myelitis,
Dr. Wientzen’s ultimate opinion was that “the vaccine had no relationship at all to S.W.’s
transverse myelitis.” Tr. 472. Rather, Dr. Wientzen opined that HHV-6 or some other virus
caused S.W.’s myelitis. Tr. 491, 502-03, 508.
14 A plausible medical theory is not the same as a persuasive medical theory. Moberly,
592 F.3d at 1322.
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The second Althen prong requires petitioners to present “a logical sequence
of a cause and effect showing that the vaccination was the reason for the injury.”
Althen, 418 F.3d at 1278. The types of evidence relevant to this prong include the
views of treating doctors, whose opinions are favored in the Vaccine Program.
Capizzano, 440 F.3d at 1326; but see 42 U.S.C. § 300aa–13(b)(1); Snyder v. Sec’y
of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009).
In the context of prong two, the Whitneys cite: (1) five medical records of
which two come from the summer 2010 or later, and (2) a single sentence from Dr.
Shafrir’s testimony. Pet’rs’ Posthr’g Br., filed May 5, 2014, at 29-32; Pet’rs’
Reply, filed July 7, 2014, at 9-11. The Secretary maintains that the evidence does
not support a finding in the Whitneys’ favor on prong 2. The Secretary dismisses
the medical records that the Whitneys cite and emphasizes other medical records in
which treating doctors linked S.W.’s transverse myelitis to his HHV-6 infection.
The Secretary also relies upon the testimony of Dr. Wiznitzer and Dr. Wientzen.
Resp’t’s Posthr’g Br., filed June 6, 2014, at 11-18.
1. Medical Records
Quoting the Federal Circuit, the Whitneys argue that statements in medical
records are “‘quite probative’” for establishing the second prong of Althen. Pet’rs’
Posthr’g Br. at 31, quoting Capizzano, 440 F.3d at 1326. Consistent with this
position, the Whitneys maintain that “opinions of treating physicians are absolutely
sufficient to demonstrate a logical sequence of cause and effect between the
vaccine and the injury.” Id.
The Secretary also quotes Capizzano. However, the Secretary also cites
other authorities that recognize that statements from treating doctors may be
“rebutted and found unreliable . . . based on the record as a whole.” Resp’t’s
Posthr’g Br. at 12, citing 42 U.S.C. § 300aa–13(b)(1); Snyder, 88 Fed. Cl. at 746
n.67; Davis v. Sec’y of Health & Human Servs., No. 07-451V, 2010 WL 1444056,
at *14 (Fed. Cl. Spec. Mstr. Mar. 10, 2010), mot. for rev. denied, 94 Fed. Cl. 53
(2010), aff’d without op., 420 Fed. App’x 973 (Fed. Cir. 2011).
Here, of the five records the Whitneys cite, the three records created years
after the transverse myelitis do not state that a vaccine caused S.W.’s transverse
myelitis. The most recent record was created in 2011 and in that record, a pediatric
orthopedist recorded that S.W. “has [a] history of spinal injury after vaccinations.”
Exhibit 5 at 253. This simply states a chronology of events. It is not a statement
of causation. See Cedillo v. Sec'y of Health & Human Servs., 617 F.3d 1328,
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1347–48 (Fed. Cir. 2010); Caves v. Sec'y of Health & Human Servs., 100 Fed. Cl.
136–37 (2011), aff'd per curiam without op., 463 Fed. Appx. 932 (Fed. Cir. 2012).
In another record, on June 23, 2010, Dr. Vogel noted that the vaccinations
S.W. was due to receive after his set of immunizations at four months were being
deferred “because of the issue [of a] potential relationship of transverse myelitis.”
Exhibit 8 at 3. Dr. Vogel’s recognition of a “potential relationship,” however, does
not advance the petitioners’ claim. See Paterek, 527 Fed. Appx. at 879 (stating
that the testimony of a treating doctor that “causation was ‘not impossible’ fails to
provide support for causation at all”).
In addition, the Whitneys cite to the form on which Dr. Rush endorsed
S.W.’s need for a wheelchair. Exhibit 5 at 380-83 (July 16, 2010). However, as
noted above, even the Whitneys’ own expert, Dr. Shafrir, did not accept this
relatively ministerial act as an expression of Dr. Rush’s views on the role
vaccinations played in S.W.’s illness. Tr. 126-28.
Thus, although the Whitneys have cited these records as supporting their
position on causation, the words in the records actually do not assist the Whitneys
in meeting their burden of proof. An additional reason for not crediting those three
records is the date when they were created. These three records were created at
least two years after S.W.’s transverse myelitis. As such, the doctor’s history
reflects the impressions of S.W.’s parents who provided the narrative to S.W.’s
doctors. See Tr. 164-65. A parent’s opinion about causation is not transformed
into a medical opinion simply because a doctor recites the parent’s version in a
medical record. See Moriarty v. Sec'y of Health & Human Servs., No. 03-2876V,
2014 WL 4387582, at *15 (Fed. Cl. Spec. Mstr. Aug. 15, 2014), mot. for rev.
denied, 2015 WL 738030 (Fed. Cl. Feb. 4, 2014), appeal docketed No. 15-5072
(Fed. Cir. Apr. 16, 2015).
A better source of information about a doctor’s opinion about the cause of an
injury is usually the records created during the acute illness. See Cucuras v. Sec’y
of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).15 These records
15 Although doctors treating a patient’s acute illness often have valuable opinions about
the cause of the condition, the doctors during the acute phase do not always have the best
information. For example, events later in the patient’s life provide insights into the nature of the
disease that were not available during the acute presentation. See Hunt v. Sec'y of Health &
Human Servs., No. 12-232V, 2015 WL 1263356, at *11 (Fed. Cl. Spec. Mstr. Feb. 23, 2015) (a
presentation of acute disseminated encephalomyelitis was later recognized as an initial
manifestation of multiple sclerosis), mot. for rev. filed (Mar. 25, 2015). In addition, physicians
15

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may contain a doctor’s opinion about causation, largely independent of a
historian’s narrative.
The Whitneys cite two records from December 2007, both from Dr. Fogg.
In a December 14, 2007 report, which was written before the discovery of HHV-6
in S.W.’s blood, Dr. Fogg identified a “post vaccination reaction” as one of many
possible causes for S.W.’s transverse myelitis. Exhibit 2 at 264-66. The second
Dr. Fogg report, which the Whitneys cited only in their reply brief, came a few
days later. After testing showed the presence of HHV-6 in S.W.’s plasma, Dr.
Fogg wrote “This [the HHV-6] or his immunizations could have been the trigger
for his ADEM.” Exhibit 2 at 166. Like Dr. Vogel’s letter from more than three
years later, a treating doctor’s inclusion of a vaccine as a possible cause does not
materially support the petitioners’ argument.
In contrast to these weak pieces of evidence, the Secretary cites to other
medical records in which treating doctors did not conclude that the vaccination
caused S.W.’s transverse myelitis. Resp’t’s Posthr’g Br., filed June 4, 2014 at 13.
On February 22, 2008, Dr. Rush considered and rejected the idea that the vaccines
could have caused S.W.’s transverse myelitis. Instead, Dr. Rush recommended
that S.W. “should get all his immunizations.” Exhibit 5 at 328.
In the undersigned’s experience, Dr. Rush’s disagreement with the
proposition that the vaccines caused his patient’s transverse myelitis is remarkably
strong and direct. His recommendation for additional vaccinations, which would
include additional doses of the DTaP vaccine, further demonstrates his conviction
that the vaccines did not harm S.W. See Andreu, 569 F.3d at 1376 (suggesting that
a treating doctor’s decision to withhold vaccinations may be evidence of a
causation).16 Significantly, in the Whitneys’ reply, they failed to address Dr.
Rush’s recommendation at all. See Pet’rs’ Reply Br., filed July 7, 2014, at 9-11.
The Whitneys have not challenged Dr. Rush’s ability to opine about causation.
From the information available, it appears that Dr. Rush is an unbiased and
who seen a patient later in the course of a disease may identify the cause of the disease after
reviewing results of tests that were not conducted initially. See Barclay v. Sec'y of Health &
Human Servs., No. 07-605V, 2014 WL 7891493, at *8 (Fed. Cl. Spec. Mstr. Dec. 15, 2014)
(Secretary’s expert recommended genetic testing, which turned out positive for a mutation in the
SCN1A gene), mot. for rev. filed (Jan. 14, 2015).
16 Although Ms. Whitney did not accept Dr. Rush's recommendation, her belief that the
vaccinations injured her son is not probative evidence that they did. See 42 U.S.C. § 300aa–
13(a)(1).
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qualified doctor who disagreed with the proposition that the vaccinations caused
S.W.’s transverse myelitis. This opinion is valuable.
In addition to Dr. Rush’s letter, other treating doctors specifically identified
the HHV-6 virus as the cause of S.W.’s transverse myelitis. In pointing to the
virus as the causative agent, the doctors were implicitly rejecting the vaccine as a
cause. One example is the neurologist who treated S.W. in the hospital. This
doctor made handwritten entries saying “HHV 6 myelitis” and “HHV-6 associated
myelitis.” Exhibit 2 at 173, 182, 186.17
A second example is Dr. DeRoos, who agreed with a parental report that
said a specialist in infectious diseases identified the HHV-6 virus as causative.
Exhibit 6 at 44-45. Despite a vigorous challenge from the Whitneys, this medical
record retains some value as evidence that the treating doctors did not consider the
vaccine to be causative. The Whitneys are correct that there is no medical record
from Dr. Fogg or any other specialist in infectious disease identifying the HHV-6
virus as the cause for the myelitis. Thus, there is a degree of hearsay in the record
from Dr. DeRoos. Nevertheless, the circumstantial evidence supports the accuracy
of the report to Dr. DeRoos. First, Dr. Fogg included HHV-6 in his list of potential
causes. Exhibit 2 at 166, 264-66. Second, Dr. Fogg knew about the positive test
for HHV-6. Exhibit 2 at 234. Third, the neurologists, at a minimum, associated
S.W.’s transverse myelitis with the HHV-6 virus. These foundational points are a
basis for drawing the inference that Dr. Fogg, in fact, told the Whitneys that the
HHV-6 virus caused their son’s transverse myelitis orally.18
In addition to challenging the specific opinion from the infectious disease
specialist that the HHV-6 virus caused S.W.’s transverse myelitis, the Whitneys
presented a broader attack on the general proposition that HHV-6 virus can cause
transverse myelitis. See Pet’rs’ Posthr’g Br., filed May 5, 2014, at 34-39; Pet’rs’
Reply Br., filed July 7, 2014, at 9-11; Pet’rs’ Resp., filed Jan. 30, 2015, at 8-10.
The Secretary responded with a robust defense of the theory that HHV-6 can cause
17 The statement “HHV-6 associated myelitis” is ambiguous as to whether the doctor was
stating that the virus caused the myelitis or the virus simply preceded the myelitis. On the other
hand, the statement “HHV 6 myelitis” more clearly expresses a causal (as opposed to simply
temporal) relationship.
18 When the undersigned asked whether information should be sought from S.W.'s
treating doctors, the Whitneys declined. See Pet’rs’ Resp., filed Jan. 30, 2015, at 5-6.
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(and for S.W., did cause) transverse myelitis. Resp’t’s Posthr’g Br., filed June 4,
2014, at 14-20; Resp’t’s Mem., filed Jan. 30, 2015, at 2-4.
The potential trouble with the Whitneys’ attack is that the arguments they
raise against the lack of evidentiary support for the theory that HHV-6 can cause
transverse myelitis are arguments that could undermine the theory that the vaccines
can cause transverse myelitis.19 In seeking to tear down the Secretary’s home, the
Whitneys risk destroying their own edifice.
Moreover, the Whitneys’ fighting over whether HHV-6 can cause transverse
myelitis overlooks Dr. Rush’s report. Even if the Whitneys succeeded in entirely
discrediting: (a) the handwritten statements from the neurologists whose reports
the Whitneys did not address directly, (b) the implicit oral statement from an
infectious disease specialist, and (c) the more formal statement from Ms.
Shelanskey / Dr. DeRoos, Dr. Rush’s report would remain. Dr. Rush discounted
the vaccinations as a cause for myelitis without referring to the HHV-6 virus.
Exhibit 5 at 328.
The Whitneys bear the burden of presenting affirmative evidence in support
of causation.20 Grant, 956 F.2d at 1149. At the end of the day, the Whitneys have
not identified even one medical record in which a treating doctor expressed the
opinion that a vaccination caused the transverse myelitis. The lack of evidence
from treating doctors is a deficit in the Whitneys’ case. See Knudsen v. Secʼy of
Health & Human Servs., 35 F.3d 543, 550 (Fed. Cir. 1994) (when the evidence is
in equipoise, the party with the burden of proof has failed to carry the burden of
persuasion); In re Claims for Vaccine Injuries Resulting in Autism Spectrum
Disorder or a Similar Neurodevelopmental Disorder, Master Autism File, 2004
WL 1660351, at *8 (Fed. Cl. Spec. Mstr. July 16, 2004) (“in legal factfinding if
there is no evidence, the factual issue simply is resolved against the party having
the ‘burden of proof’”). The absence of affirmative evidence from treating
physicians is especially significant because Dr. Rush’s report constitutes evidence
against the proposition. When there is no evidence in favor of the proposition and
19 For example, the Whitneys argued that “Dr. Wientzen indicated that there was no
homology between HHV-6 and spinal cord components.” Pet’rs’ Posthr’g Br. at 38, citing Tr.
569. But, with respect to the DTaP vaccine, Dr. Shafrir stated the lack of “common homology
. . . doesn’t mean anything,” and Dr. Oleske was not aware of any homology. Tr. 64, 415-17.
20 “Affirmative evidence” means evidence in support of the proposition. “Affirmative
evidence” does not mean scientifically certain evidence.
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some unrebutted evidence against the proposition, the evidence must weigh against
the proposition.21
2. Expert Testimony
While the treating doctors, on a whole, do not assist the Whitneys in meeting
their burden for prong two, the Whitneys may still prevail by presenting a
persuasive case through their retained experts. See 42 U.S.C. § 300aa–13(a).
However, the Whitneys’ evidence from Dr. Shafrir and Dr. Oleske was thin and
not persuasive.
In their briefs regarding prong 2, the Whitneys cite one passage from Dr.
Shafrir (and nothing from Dr. Oleske). After Dr. Shafrir expressed his opinion that
the vaccinations “substantially contributed to” the transverse myelitis, he provided
the basis for this opinion. He stated “the known relationship between vaccines in
general and transverse myelitis, the previous case reports associating this particular
vaccine . . . with transverse myelitis, and the time course and the lack of . . . any
other stimulation as strong as the vaccine to explain this appearance of transverse
myelitis.” Tr. 34.22 Dr. Shafrir repeated this position later. Tr. 148.
Dr. Oleske’s reasoning was similar. When asked for the basis that the
vaccinations caused S.W.’s transverse myelitis, Dr. Oleske indicated that an
“immunological reaction that’s initially non-specific and related to things like
cytokines can, in fact, cause unfortunately bystander damage to tissues. . . [And,]
the timing of when he got the immunization as well and the development of
transverse myelitis all fit into the temporal relationships we see when we immunize
someone with multiple antigens.” Tr. 338. Although, in this passage, Dr. Oleske
21 In this case, the evidence from the treating doctors preponderates against the Whitneys.
However, in other cases, the evidence from the treating doctors favors the petitioners. When the
evidence from treating doctors supports a finding of causation, the parties typically resolve the
case without the need for a formal adjudication by a special master.
22 Although Dr. Shafrir opined that the vaccinations stimulated S.W.’s immune system
more than the roughly concurrent infection with HHV-6, Dr. Wiznitzer testified that “the amount
of antigen load from the immunization is trivial compared to what you get from the infectious
illness.” Tr. 259. Dr. Shafrir, then, retreated from his assertion that the vaccines present a
greater immunologic challenge. Tr. 297. The two immunologists differed on the question as to
what presents a greater immunologic challenge, either a vaccination or an infection. Compare
Tr. 398-407 (Dr. Oleske) with Tr. 564-67 (Dr. Wientzen).
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did not specifically mention that he considered HHV-6 not to be the cause, in other
portions of his testimony, Dr. Oleske actually did rule out HHV-6. Tr. 324-25.
The core of Dr. Shafrir’s and Dr. Oleske’s opinions for prong 2 is a series of
three assertions: (1) the vaccine can cause the disease, (2) the timing is
appropriate, and (3) the exclusion of other potential factors. Whether the evidence
truly satisfies the first and third postulates is debatable. But, a flaw in the
Whitneys’ case does not depend upon whether they succeeded in establishing, by a
preponderance of the evidence, that the DTaP vaccination can cause transverse
myelitis or that HHV-6 does not cause transverse myelitis. Rather, even if these
assertions were credited, the problem with the Whitneys’ presentation is that the
Federal Circuit “has previously rejected the same argument --- that proof that an
injury could be caused by a vaccine and that the injury occurred within an
appropriate period of time following the vaccination is sufficient to require an
award of compensation unless the respondent can prove some other cause for the
injury.” Hibbard, 698 F.3d at 1365-66; (citing Moberly, 592 F.3d at 1323); Althen,
418 F.3d at 1278; see also Caves v. Sec'y of Health & Human Servs., No. 07-
443V, 2010 WL 5557542, at *21 (Fed. Cl. Spec. Mstr. Nov. 29, 2010) (citing
Moberly), 592 F.3d at 1323, mot. for rev. denied, 100 Fed. Cl. 119, 135 (finding
special master’s determination on prong two was “not erroneous”), aff’d without
op., 463 Fed. App’x 932 (Fed. Cir. 2012).
In Moberly and Althen, the two cases Hibbard cited, the Federal Circuit
provided additional insights into the prong two analysis. Hibbard interpreted
Moberly as establishing that “‘temporal association between a vaccination and a
seizure, together with the absence of any other identified cause for the ultimate
neurological injury’ is evidence of causation but does not by itself compel a
finding of causation.” Hibbard, 698 F.3d at 1366. So, too, in this case, Dr.
Shafrir’s opinion and Dr. Oleske’s opinion constitute some evidence in favor of
causation.
Hibbard also quoted Althen, 418 F.3d at 1278, for the proposition that
“neither a mere showing of a proximate temporal relationship between vaccination
and injury, nor a simplistic elimination of other potential causes of the injury
suffices, without more, to meet the burden of showing actual causation.” Hibbard,
698 F.3d at 1366. This reference to needing something “more” might be satisfied
in some cases with persuasive statements from treating doctors. But, as discussed
in the preceding section, the Whitneys have not identified any treating doctor who
stated the vaccines caused S.W.’s transverse myelitis. The treating doctors are
actually against this proposition.
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Consequently, when the record is considered as a whole, the Whitneys have
not met their burden of proof for prong two.
D. Factor Unrelated
Because transverse myelitis is not listed on the Vaccine Injury Table, the
petitioners must establish that the vaccinations were the cause-in-fact of S.W.’s
transverse myelitis. They would meet this burden by establishing the three Althen
prongs. Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1379 (Fed.
Cir. 2012). However, for the reasons just explained, the Whitneys have not done
so for prong two.
If the Whitneys had presented preponderant evidence on each Althen prong,
then the burden would have shifted to the Secretary to present preponderant
evidence that S.W.’s transverse myelitis was “due to factors unrelated” to the
vaccinations. 42 U.S.C. § 300aa–13(a)(1)(B); accord Deribeaux v. Sec’y of Health
& Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013). But, in this case, the
burden did not shift. See Doe 11 v. Sec’y of Health & Human Servs., 601 F.3d
1349, 1357-58 (Fed. Cir. 2010).
The finding that the Whitneys did not meet their burden of establishing that
the vaccinations caused S.W.’s transverse myelitis is a sufficient basis to deny
compensation. The finding that the vaccine did not cause the injury “necessarily
implies some other cause resulted in the injury.” Bazan, 539 F.3d at 1353. Under
the circumstances of this case, the Secretary is not required to establish what that
other cause is. LaLonde v. Sec’y of Health & Human Servs., 746 F.3d 1334, 1341
(Fed. Cir. 2014) (“Additionally, it was not the government’s burden to provide an
alternative explanation”).
Conclusion
Mr. and Ms. Whitney have presented a plausible case that the vaccinations
caused S.W.’s transverse myelitis. Their sincere belief, however, conflicts with the
opinions of the doctors who treated S.W., particularly Dr. Rush.
Congress reserved compensation in the Vaccine Program to those people
who, among other elements, established that a vaccine caused the injury for which
they seek compensation. The Whitneys have not made this showing. Therefore,
they are not entitled to compensation.
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The Clerk’s Office is instructed to enter judgment in accord with this
decision.
IT IS SO ORDERED.
s/ Christian J. Moran
Christian J. Moran
Special Master
22

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DOCUMENT 2: USCOURTS-cofc-1_10-vv-00809-1
Date issued/filed: 2015-08-12
Pages: 24
Docket text: Docketed for Administrative Purposes VACCINE REISSUED REPORTED OPINION & ORDER, reflecting no redactions from the opinion and order previously entered under seal on July 28, 2015. Signed by Judge Charles F. Lettow. (jt1) Copy to parties.
--------------------------------------------------------------------------------
Case 1:10-vv-00809-CFL Document 130 Filed 08/12/15 Page 1 of 24
In the United States Court of Federal Claims
No. 10-809V
(Filed Under Seal: July 28, 2015)
(Reissued: August 12, 2015)
************************************* )
) Vaccine case; dispute over Althen prong
REBECCA WHITNEY AND RANDALL ) two – logical sequence of cause and
WHITNEY, parents of S.W., a minor, ) effect between the vaccinations and the
) injury; remand
Petitioners, )
)
v. )
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Defendant. )
)
*************************************
Ronald C. Homer, Conway, Homer & Chin-Caplan, P.C., Boston, Massachusetts for
petitioners. Representing petitioners at the hearing was Meredith Daniels, Conway, Homer &
Chin-Caplan, P.C., Boston, Massachusetts.
Lara A. Englund, Trial Attorney, Torts Branch, Civil Division, United States Department
of Justice, Washington, D.C., for defendant. With her on the brief was Benjamin C. Mizer,
Principal Deputy Assistant Attorney General, Civil Division, Rupa Bhattacharyya, Director,
Torts Branch, Vincent J. Matanoski, Deputy Director, Torts Branch, and Voris E. Johnson, Jr.,
Assistant Director, Torts Branch, Civil Division, United States Department of Justice,
Washington, D.C.
OPINION AND ORDER1
LETTOW, Judge.
Petitioners, Rebecca and Randall Whitney, on behalf of their son, S.W., seek review of a
decision by a special master filed May 8, 2015, denying them an award under the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, § 311, 100 Stat. 3743, 3755 (1986)
1In accord with the Rules of the Court of Federal Claims (“RCFC”), App. B (“Vaccine
Rules”), Rule 18(b), this opinion and order was initially filed under seal. By rule, the parties
were afforded fourteen days in which to propose redactions. No redactions were requested.

Case 1:10-vv-00809-CFL Document 130 Filed 08/12/15 Page 2 of 24
(codified, as amended, at 42 U.S.C. §§ 300aa-1 to -34) (“Vaccine Act”). The Whitneys allege
that the injection of their son with diphtheria-tetanus-acellular-pertussis (“DTaP”), Haemophilus
influenzae type b (“Hib”), inactivated polio (“IPV”), pneumococcal conjugate (“PCV”), and
rotavirus vaccines, administered on November 26, 2007, caused him to develop transverse
myelitis, a severe neurologic disorder. Pet’rs’ Mem. in Support of Mot. for Review of the
Special Master’s May 8, 2015 Decision (“Pet’rs’ Mem.”), ECF No. 116.2 The Secretary of
Health and Human Services (“the government”) acknowledges that S.W. suffered from an
episode of transverse myelitis and continues to have adverse effects from that condition but
argues that its cause is unrelated to administration of the vaccines. Response to Mot. for Review
(“Resp’t’s Mem.”), ECF No. 119.
Transverse myelitis is an “off-Table” vaccine injury for which petitioners must establish
causation in fact by preponderant evidence. See 42 U.S.C. §§ 300aa-11(c)(1)(B), (C)(ii)(I),
300aa-13(a)(1); see also Althen v. Secretary of Health & Human Servs., 418 F.3d 1274, 1278
(Fed. Cir. 2005). The special master, applying the causation framework set out in Althen, denied
relief on the ground that the Whitneys failed to provide a logical sequence of cause and effect
between the vaccinations and transverse myelitis. See Whitney v. Secretary of Health & Human
Servs., No. 10-809V, slip op. at 14 (Fed. Cl. Spec. Mstr. May 8, 2015) (“Entitlement Decision”).
On review, the Whitneys aver that the special master’s decision was arbitrary and capricious and
his reasoning was contrary to relevant legal standards. The government responds that the special
master’s decision was in accordance with law and should not be set aside.
2Transverse myelitis is a neurological disorder “characterized by the sudden onset of
rapidly progressive weakness of the lower extremities, accompanied by loss of sensation and
sphincter control, and often preceded by a respiratory infection.” John H. Menkes, Textbook of
Child Neurology (“Child Neurology”) 535 (Williams & Wilkins, 5th ed. 1995). For individuals
with transverse myelitis, “[t]he spinal cord is generally softened, with the most striking changes
occurring in the thoracolumbar region. . . . In the affected area, the spinal cord is often
completely necrotic; all nervous elements are lost, replaced by a cellular infiltrate or by
cavitation.” Id. at 535-36; see also Tr. 159:11-17 (Test. of Dr. Max Wiznitzer, an expert witness
called by the government). The transcript of the entitlement hearing before the special master
held on February 27, 2014 and March 7, 2014 will be cited as “Tr. __.”
Very little information exists about the etiology of transverse myelitis because the
condition is rare. See Tr. 14:10-28 (Test. of Dr. Yuval Shafrir, an expert witness called by
petitioners). Researchers believe that transverse myelitis is caused by either a “direct infection
or by a parainfectious or postinfectious process.” Tr. 159:18-20 (Wiznitzer) (a parainfectious
process connotes a manifestation of an infectious disease caused by an immune response to an
infectious agent); see also Child Neurology at 536 (“The condition can be caused by . . .
autoimmune diseases, bacterial, viral, or spirochetal infections, and vascular malformations.”).
2

Case 1:10-vv-00809-CFL Document 130 Filed 08/12/15 Page 3 of 24
BACKGROUND
A. S.W.’s Medical History
S.W. was born in July 2007. Pet’rs’ Ex. 1, at 1 (Medical Records from Michigan
Medical Pediatrics (June 8, 2011)).3 During the first four months of his life, S.W. was healthy,
and his pediatric records did not show any problems with development or illnesses. See id. Ex.
13, at 1-7 (Additional medical records from Michigan Medical Pediatrics). In mid-November of
2007, S.W. developed a mild upper respiratory infection, and other members of his family
displayed similar symptoms. Id. Ex. 2, at 255 (History and Physical Report by Dr. Beatrice
Guadalu Zepeda (Dec. 13, 2007)) & 264 (Consultation Report by Dr. George Fogg (Dec. 14,
2007)). His family did not take S.W. to a doctor, but tests conducted later indicated that he
probably then was suffering from a human herpesvirus 6 (“HHV-6”) infection. Entitlement
Decision at 2 n.3; see also Tr. 493:15-24 (Test. of Dr. Raoul Weintzen, an expert who also
testified on behalf of the government) (“I think he had an active HHV-6 infection at about
Thanksgiving when, by history, he had the upper respiratory infection we read about in the
medical record, the cold, runny nose, cough, and so on.”).4 On November 26, 2007, S.W. saw
his doctor for his four-month pediatric well-child visit. Pet’rs’ Ex. 13, at 5. At this appointment,
S.W. received the DTaP, Hib, PCV, IPV, and rotavirus vaccines. Id. Ex. 10, at 1 (Medical
Records from Dr. Donnie Reinhart (June 2, 2011)).
Around December 6, 2007, S.W. showed signs of “some congestion and upper
respiratory symptoms,” but “[n]o nausea, vomiting, [or] diarrhea.” Pet’rs’ Ex. 2, at 261
(Physician Report (Dec. 13, 2007)). He also “appeared to be straining whenever he stooled.” Id.
Ex. 2, at 253 (History and Physical Reports (Dec. 13, 2007)). Experts testifying for both parties
testified that this condition indicated that S.W. may have developed neurologic problems at this
time. See Tr. 160:10-19 (Wiznitzer), 280:6-14 (Test. of Dr. James Oleske, an expert who also
testified on behalf of petitioners). A few days later, on December 12, 2007, S.W.’s mother
noticed that his legs were shaking, and she stayed “up with him . . . that night, rocking and
consoling him so he could get back to sleep.” Pet’rs’ Ex. 14, at ¶¶ 5-6 (Aff. of Rebecca Whitney
(Mar. 19, 2012)). The next day, on December 13, 2007, S.W.’s mother took him to see the
pediatrician, and she noted that S.W. had not been moving for two days and would scream when
waking up or when moving his legs. See id. Exs. 1, at 46 (General Visit Report (Dec. 13, 2007))
& 14, at ¶ 8. S.W. was observed to have decreased muscle tone in his lower extremities, “some
3Documentary materials made part of the record by petitioners are cited as “Pet’rs’ Ex.
__, at __.”
4HHV-6 is a “ubiquitous virus that is an etiologic agent of exanthema subitum[,] . . . a
short lived disease of infants and young children.” Dorland’s Illustrated Medical Dictionary
(“Dorland’s”) 664, 864 (Saunders Elsevier, 31st ed. 2007); see also Child Neurology at 428.
“Most healthy adults carry the virus and are asymptomatic.” Dorland’s at 864.
3

Case 1:10-vv-00809-CFL Document 130 Filed 08/12/15 Page 4 of 24
clonus,”5 and absent reflexes. Id. Ex. 1, at 46. Experts from the parties concurred that the
presence of clonus indicated that S.W. had been suffering from neurological problems for seven
to ten days. See Tr. 66:1-5 (Shafrir), 194:22 to 195:2 (Wiznitzer). Based on his symptoms, S.W.
was admitted to the emergency room and sent to the pediatric intensive care unit. Pet’rs’ Ex. 2,
at 261. His admission record stated a history similar to that provided by the pediatrician who
saw him. See id. Ex. 2, at 253-55. While S.W. was in the hospital, doctors took blood samples,
consulted with a neurologist, and performed a lumbar puncture to remove a sample of
cerebrospinal fluid. Id. Ex. 2, at 261. The latter sample showed inflammation in the spinal cord.
Id. Ex. 2, at 254; see also Entitlement Decision at 3.
Doctors also ordered a series of MRIs and prescribed the antibiotic Rocephin to treat a
possible bacterial infection. Pet’rs’ Ex. 2, at 255; see also Tr. 97:8-25 (Shafrir). Prior to the
MRIs, a neurologist, Dr. Steven DeRoos, examined S.W. and reported that S.W. had “[n]o acute
febrile illness recently” and “agree[d] with the IV antibiotics until more information [wa]s
known.” Id. Ex. 2, at 267-68 (Consultation Report by Dr. DeRoos (Dec. 13, 2007)). On
December 13, 2007, S.W. had four MRIs. See id. Ex. 2, at 249-52 (Magnetic Resonance
Imaging Report (Dec. 13, 2007)). The images of the brain and lumbosacral spine were normal,
but the images of the cervical spine and thoracic spine showed that “[a] form of myelopathy in
the mid and lower cervical spinal cord exist[ed].” Id. at 250. According to the radiologist,
Dr. Edward Bok, the results “suggest[ed] the likelihood that this represent[ed] an immune
mediated disseminated myelitis, perhaps parainfectious in etiology.” Id. Ex. 2, at 250.
The next day, on December 14, 2007, Dr. Fogg, a pediatric infectious disease specialist,
evaluated S.W. and noted that the child “[wa]s a four-month old . . . responding to high-dose
steroids” who received “DTaP, ITB, Hib, pneumococcal conjugate vaccine[s], and rotavirus
vaccine” on November 26, 2007. Pet’rs’ Ex. 2, at 264 (Consultation Report by Dr. Fogg (Dec.
14, 2007)). Dr. Fogg concluded that S.W.’s presentation of symptoms was “consistent with
acute disseminated encephalomyelitis ([‘]ADEM[’]).” Id. Ex. 2, at 265.6 For “infectious
triggers,” Dr. Fogg listed “viral (CMV, EBV, HSV, enterovirus and West Nile), bacterial
(Campylobacter, and mycoplasma), post vaccination reaction, or autoimmune disease” as
possibilities. Id. He made several recommendations that included a request for a polymerase
chain reaction (“PCR”) test to detect several types of pathogens, including HHV-6, which may
have been present in S.W.’s blood plasma. Id. Ex. 2, at 265-66. Finally, Dr. Fogg “agree[d]
with the plans for high-dose steroid therapy as directed by pediatric neurology” and stated that
5The term “clonus” is defined as “alternate muscular contraction and relaxation in rapid
succession” and “a continuous rhythmic reflex tremor initiated by the spinal cord below an area
of spinal cord injury.” Dorland’s at 379.
6The term “encephalomyelitis” is defined as “inflammation involving both the brain and
the spinal cord.” Dorland’s at 621. ADEM is “a manifestation of an autoimmune attack on the
myelin of the central nervous system. . . . It occurs most commonly following an acute viral
infection.” Id.; see also Child Neurology at 521. Symptoms of ADEM include “fever, headache,
vomiting, and drowsiness progressing to lethargy[,] and coma, seizures, and paralysis may also
occur.” Dorland’s at 621.
4

Case 1:10-vv-00809-CFL Document 130 Filed 08/12/15 Page 5 of 24
he would “report the possible post immunization adverse event to the [V]accine [A]dverse
[E]vent [R]eporting [S]ystem [(‘VAERS’)].” Id. Ex. 2, at 266 (emphasis added).7
Following Dr. Fogg’s assessment and the resulting testing, lab results indicated that S.W.
had 4,100 copies of the HHV-6 per milliliter of plasma. Pet’rs’ Ex. 2, at 234 (General Lab
Reports (Dec. 14, 2007)). When “testing . . . show[ed] evidence of HHV-6 infection,” Dr. Fogg
wrote that “[the HHV-6 virus] or his immunizations could have been the trigger for his ADEM.”
Id. Ex. 2, at 166 (Progress Notes by Dr. Fogg (Dec. 17, 2007)) (emphasis added).8 A pediatric
neurologist who saw S.W. while he was in the hospital indicated that S.W. had “HHV[-]6
myelitis.” Id. Ex. 2, at 186 (Rounding Report (Dec. 21, 2007));9 see also Entitlement Decision at
5. S.W. remained in the hospital until December 21, 2007, when he was transferred to an
inpatient rehabilitation hospital, Mary Free Bed Hospital. Pet’rs’ Ex. 2, at 270-72 (Discharge
Documentation (Dec. 21, 2007)). S.W. remained at Mary Free Bed Hospital until January 2,
2008. Id. Ex. 5, at 47-50 (Physician Discharge Summary (Jan. 2, 2008)).
On February 17, 2008, S.W. went to a neurology clinic for a follow-up appointment. See
Pet’rs’ Ex. 6, at 44 (Letter from Kim Shelanskey, family nurse practitioner, and signed by
Dr. DeRoos, to Dr. Stephen McMahon (Feb. 17, 2008)). Ms. Shelanskey recited the following
history of S.W.’s illness:
[S.W.] is nearly 7-month-old male who was initially evaluated by
Dr. Steven DeRoos during a hospitalization in December 2007 for
transverse myelitis. At that time, [S.W.] presented with a 1-day
history of decreased movement in his lower extremities. A full
workup was completed in the hospital and included an MRI of the
cervical spine which showed an abnormal signal running from the
C2-C3 area in a rostrocaudal fashion to the upper thoracic spinal
canal. This was thought to be a form of myelopathy. Infectious
Disease was able to identify the HHV-6 virus as the causative
agent.
7“VAERS is a database maintained by the Center for Disease Control (‘CDC’) to compile
information from reports about reactions to immunizations listed on the Vaccine Injury Table, 42
U.S.C. § 300aa-14(a).” Analla v. Secretary of Health & Human Servs., 70 Fed. Cl. 552, 556
(2006).
8At this time, “doctors listed [S.W.]’s diagnosis as ADEM. However, another doctor
(Dr. Adam Rush) disagreed with the diagnosis of ADEM because [S.W.]’s problem was limited
to his spine and did not affect his brain.” Entitlement Decision at 5 n.7 (citing Pet’rs’ Ex. 5, at
328). During the Entitlement Hearing, testifying neurologists agreed with the diagnosis of
transverse myelitis and not ADEM. See, e.g., Tr. 198:4-12 (Wiznitzer) (“[S.W.] had . . .
transverse myelitis.”). The diagnosis of transverse myelitis is not in dispute.
9A neurologist also wrote “HHV-6 associated myelitis” in another medical note. Pet’rs’
Ex. 2, at 182 (Runding Report (Dec. 20, 2007)).
5

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Id. (emphasis added).10 Ms. Shelanskey also noted that S.W. was “making nice gains and
continues to work with both occupational therapy and physical therapy through Mary Free Bed
[Hospital].” Id. Ex. 6, at 45. Dr. DeRoos, the neurologist “directly involved with formulating
the plan [for S.W.’s care,] . . . agree[d] with [Ms. Shelanskey’s] assessment.” Id. Two days
later, on February 19, 2008, S.W. saw a urologist, Dr. Brian Roelof, who noted that “[S.W.]
seems to be improving.” Id. Ex. 4, at 17 (Initial Visit Report by Dr. Roelof (Feb. 19, 2008)).
S.W.’s mother informed Dr. Roelof that she “thought he had acute viral myelitis secondary to a
virus or perhaps from his vaccinations.” See id.
On February 22, 2008, S.W. had an appointment with a physiatrist,11 Dr. Rush, who had
previously cared for S.W. at Mary Free Bed Hospital. Mr. and Mrs. Whitney reported to
Dr. Rush that S.W. was experiencing a “dramatic return of strength and apparent sensation in his
bilateral[] lower limbs since [his last visit].” Pet’rs’ Ex. 5, at 327 (Final Report by Dr. Rush
(Mar. 4, 2008)). Mr. and Mrs. Whitney also informed Dr. Rush that they were “not planning at
this time for him to receive any more immunizations.” Id. Dr. Rush did not address the issue of
“immunization noncompliance” with S.W.’s parents at this appointment, but noted in his report
that:
[i]t is incredibly important that like any other child, [S.W.] get his
immunizations. I can only surmise at this point that his parents are
reluctant to give him immunizations in the misguided belief that
immunizations were the cause of his myelitis. I do not have any
reason to believe this is the case, nor do I believe literature would
[bear] that out. He should get all his immunizations.
Id. Ex. 5, at 328 (emphasis added). S.W. returned to see Dr. Rush a few months later, on June 4,
2008. S.W.’s mother reported to Dr. Rush that S.W. was suffering from the “occasional
(approximately daily) spasms of the lower limbs . . . [and] shaking episodes,” but they “[did] not
seem to cause him any discomfort.” Id. Ex. 5, at 325 (Final Report by Dr. Rush (June 13,
2008)). During this appointment, Dr. Rush “touch[ed] upon the issue of immunizations again
with S.W.’s mother.” Id. Ex. 5, at 326. According to Dr. Rush, Ms. Whitney felt “very strongly
10Notably, the pediatric infectious disease specialist, Dr. Fogg, had not identified HHV-6
as the infectious agent, but rather listed HHV-6 along with S.W.’s immunizations as alternative
causes, see supra, at 5; see also Tr. 122:8-13 (Shafrir).
11A physiatrist, or rehabilitation physician, is a medical doctor who has “completed
training in the medical specialty of physical medicine and rehabilitation.” American Academy of
Physical Medicine and Rehabilitation, What is a Physiatrist?, available at https://www.aapmr.
org/patients/aboutpmr/Pages/physiatrist.aspx. A physiatrist is responsible for “[d]iagnosing and
treat[ing] pain.” Id.; see also Dorland’s at 1464 (“Physiatry [is] the branch of medicine that
deals with the prevention, diagnosis, and treatment of disease or injury, and the rehabilitation
from resultant impairments and disabilities.”) (emphasis added).
6

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at [that] point [in time] against resuming [vaccinations] now, though she did seem to leave the
door open for [S.W.] receiving his immunizations at some point in the future.” Id.
On September 15, 2008, S.W. had an appointment with his neurologist, Dr. DeRoos.
Mr. and Mrs. Whitney were concerned that S.W. was experiencing seizures. Pet’rs’ Ex. 5, at 319
(Letter from Amy Tolliver, signed by Dr. DeRoos, to Dr. McMahon (Sept. 15, 2008)).
Dr. DeRoos concluded that the spells experienced by S.W. “could represent seizure[s]” and
recommended “obtain[ing] a repeat MRI.” Id. Ex. 5, at 320. The results from the repeat MRIs
were “unremarkable . . . with resolution of abnormal cord signal previously seen on the study of
12/13/2007.” Id. Ex. 6, at 53 (Magnetic Resonance Imaging Report (Jan. 12, 2009)).
On June 23, 2010, about two and a half years after S.W.’s onset of transverse myelitis, he
was seen by a pediatrician, Dr. Lawrence Vogel, in a routine follow-up. Dr. Vogel summarized
events from when S.W. was approximately five months old, stating that “[S.W.] developed
irritability and constipation . . . about 2 to 2-1/2 weeks after receiving immunizations at the 4-
month mark.” Pet’rs’ Ex. 8, at 2 (Outpatient History and Physical Report (June 27, 2010)).
Dr. Vogel also recounted that “[S.W.]’s MRI was consistent with transverse myelitis” and that
doctors had found “herpes virus 6 isolated in [S.W.’s plasma] but whether or not this was related
to that or immunizations has never been clarified.” Id. Finally, Dr. Vogel recorded that S.W.’s
“[i]mmunizations were up-to-date as of [four] months, but because of the . . . potential
relationship [to] transverse myelitis[,] immunizations are being deferred at the current time.” Id.
Ex. 8, at 3.
Shortly thereafter, on July 2, 2010, S.W. was seen by an occupational therapist, Karen
Gora, “for an evaluation for independent manual mobility and advice for facilitating independent
transfers.” Pet’rs’ Ex. 5, at 380 (Evaluation by Ms. Gora and signed by Dr. Rush (July 14,
2010)). In a “Letter of Medical Necessity” regarding S.W.’s orthopedic equipment needs,
Ms. Gora listed S.W.’s diagnosis as “Paraplegia, Myelitis (Reaction to an Immunization at age 4
months).” Id. (emphasis added). Based on her evaluation, Ms. Gora recommended the use of
orthopedic equipment, including a manual wheelchair and a custom seating system. Id. Ex. 5, at
382-83. Dr. Rush agreed with these recommendations. Id. Ex. 5, at 383.12
S.W. has remained in therapy, but he continues to experience sequelae of transverse
myelitis. See generally Pet’rs’ Exs. 5, 24 (Updated Medical Records from Shriners Hospital for
Children), & 25 (Medical Records from Mary Free Bed Rehabilitation Hospital). The
complications include “secondary spastic paraparesis,13 neurogenic bladder and bowel,” and
sensory deficits in his legs. Id. Ex. 22, at 3 (Progress Notes (Dec. 5, 2013)). Since starting
12More recently, on June 5, 2012, S.W. was seen by Dr. Allen Bragdon for a fever and
abdominal pain. Pet’rs’ Ex. 26, at 178 (Physician Report by Dr. Bragdon). Dr. Bragdon
reported that “[t]his is a 5-year-old child who unfortunately contacted transverse myelitis after
immunization at [four] months old. . . . Immunizations are not up to date [because S.W.’s]
[m]other opted not to do any further immunizations after the incident at 4 months old.” Id.
13Paraparesis is the “partial paralysis of the lower limbs.” Dorland’s at 1400.
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Case 1:10-vv-00809-CFL Document 130 Filed 08/12/15 Page 8 of 24
school, S.W. becomes easily fatigued and has difficulty learning. Id. He also has delays in his
speech, uses a wheelchair or forearm crutches, and wears a diaper to school. Id. The transverse
myelitis has left S.W. with severe disabilities. See Tr. 116:17-24 (Shafrir) (“[T]ransverse
myelitis [is] a monophasic inflammatory disease that goes away . . . and in spite of the fact that
it’s a monophasic condition[] that goes away, [the patients] are left with very significant
disabilit[ies].”); see also Pet’rs’ Ex. 14 (Aff. of Mrs. Whitney), at ¶ 16 (“[S.W.] has had to
endure intense physical therapy, countless medical tests, numerous doctor’s appointments, long
car rides, and time away from family in order to receive proper medical treatment . . . . [M]y
child [has] face[d] such adversity at a young age.”).
B. Special Master’s Decision
The Whitneys filed their petition for compensation on November 22, 2010, alleging that
S.W. “suffered a demyelinating neurological disorder” after receipt of his childhood vaccines.
Pet’rs’ Pet. for Vaccine Compensation (“Pet.”) at 1, ECF No 1.14 Hearings in this case were
conducted by the special master in two sessions during February and March of 2014. At the
hearings, the parties were in agreement both about the chronology of events and that S.W.
suffered from transverse myelitis. See Entitlement Decision at 10. The parties disagreed
sharply, however, as to the cause or causes of S.W.’s transverse myelitis. The Whitneys relied
upon medical records, medical literature, and expert testimony of Dr. Yuval Shafrir and
Dr. James Oleske to show that S.W.’s vaccine inoculations caused his transverse myelitis. See
Pet’rs’ Post-Hearing Br., ECF No. 103.15 The government disagreed with the Whitneys’ theory
of causation, alleging that the treating physician’s statements and expert testimony cited by
petitioners were unpersuasive and failed to eliminate HHV-6 as the cause of S.W.’s condition.
See Resp’t’s Post-Hearing Br., ECF No. 104. To support its arguments, the government offered
14The Whitneys initially filed this case pro se, but subsequently they retained counsel.
Entitlement Decision at 8.
15Dr. Yuval Shafrir is board-certified in clinical neurophysiology and has a special
qualification in child neurology. Tr. 11:22-24 (Shafrir); see also Curriculum Vitae, Yuval
Shafrir M.D., ECF No. 52-3. Besides a private medical practice, he currently serves as Assistant
Professor, Department of Pediatrics, University of Maryland School of Medicine, Baltimore,
Maryland, and Assistant Professor in Neurology and Pediatrics, United Services University of
the Health Sciences, F. Edwards Herbert School of Medicine, Bethesda, Maryland. Curriculum
Vitae, Yuval Shafrir, M.D.
Dr. James Oleske is board-certified in pediatrics as well as allergy, immunology, and
pediatric infectious diseases. Tr. 317:12-13 (Oleske); see also Curriculum Vitae, James M.
Oleske, M.D., MPH, ECF No. 70-3. Dr. Oleske is François-Xavier Bagnoud Endowed Chair
Professor of Pediatrics, University of Medicine and Dentistry of New Jersey, Newark, New
Jersey. Curriculum Vitae, James M. Oleske, M.D., MPH.
8

Case 1:10-vv-00809-CFL Document 130 Filed 08/12/15 Page 9 of 24
testimony from Dr. Max Wiznitzer and Dr. Raoul Weintzen and emphasized medical records
discussing S.W.’s HHV-6 infection. Id.16
The special master issued a decision denying compensation on May 8, 2015. Entitlement
Decision at 22. The special master concluded that the Whitneys had failed to prove that the
vaccines administered to S.W. on November 26, 2007 caused his transverse myelitis. Id. In so
holding, the special master applied the three-prong test set forth in Althen, 418 F.3d 1274, which
requires that a petitioner
show by preponderant evidence that the vaccination brought about [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 vaccination and injury.
Id. at 1278.
The special master concluded that the Whitneys had carried their burden with respect to
prongs 1 and 3 of the Althen framework. Entitlement Decision at 11-13. However, upon
analyzing the second prong of Althen, i.e., relating to a logical sequence of cause and effect, the
special master determined that although the Whitneys “ha[d] presented a plausible case that the
vaccinations caused S.W.’s transverse myelitis, [this] belief . . . conflict[ed] with the opinions of
the doctors who treated [S.W.].” Id. at 22. As he put it, “the Whitneys have not identified even
one medical record in which a treating doctor expressed the opinion that a vaccination caused the
transverse myelitis.” Id. at 18-19. Additionally, according to the special master, the opinions
from Dr. Shafrir and Dr. Oleske were “thin and not persuasive” and failed to amount to
“something ‘more’” needed to meet the burden of showing actual causation. Id. at 19-21 (citing
Hibbard v. Secretary of Health & Human Servs., 698 F.3d 1355, 1358 (Fed. Cir. 2012)). After
discounting the medical records and expert testimony offered by the Whitneys, the special master
gave credence to the report written by Ms. Shelanskey and signed by Dr. DeRoos, stating:
Dr. DeRoos . . . agreed with a parental report that said a specialist
in infectious diseases identified the HHV-6 virus as causative. . . .
The Whitneys are correct that there is no medical record from
Dr. Fogg or any other specialist in infectious disease identifying
16Dr. Max Wiznitzer is board-certified in pediatrics and neurodevelopmental disabilities
with a special qualification in child neurology. Tr. 155:8-11 (Wiznitzer); see also Curriculum
Vitae, Max Wiznitzer, M.D., ECF No. 57-6. Besides work at Rainbow Babies and Children’s
Hospital, Cleveland, Ohio, he serves as Associate Professor of Pediatrics, Neurology, and
International Health, Case Western Reserve University, Cleveland, Ohio. Curriculum Vitae,
Max Wiznitzer, M.D.
Dr. Raoul Weintzen is board-certified in pediatrics. Tr. 466:7 (Weintzen); see also
Curriculum Vitae, Raoul L. Weintzen, Jr., M.D., ECF No. 57-2. Dr. Weintzen serves as
Professor, Department of Pediatrics, Georgetown University School of Medicine, Washington,
D.C. Curriculum Vitae, Raoul L. Weintzen, M.D.
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the HHV-6 virus as the cause for the myelitis. Thus, there is a
degree of hearsay in the record from Dr. DeRoos. Nevertheless,
the circumstantial evidence supports the accuracy of the report to
Dr. DeRoos.
Id. at 17 (citing Pet’rs’ Ex. 6, at 44-45). Also, the special master inferred that Dr. Fogg had
spoken to the Whitneys to inform them that their son’s transverse myelitis was caused by the
HHV-6 virus. Id. at 17-19 (citing Pet’rs’ Ex. 2, at 166, 234, & 264-66). The special master
ultimately concluded that “when the record is considered as a whole, the Whitneys have not met
their burden of proof for prong two.” Id. at 21.
The Whitneys’ motion for review, filed on June 8, 2015, has been fully briefed, and a
hearing on the motion was held on July 22, 2015. See Hr’g Tr. on Pet’rs’ Mot. to Review (July
22, 2015).17 The case is now ready for disposition.
STANDARDS FOR REVIEW
Pursuant to the Vaccine Act, in reviewing a special master’s decision, the court may take
any one of the following three actions:
(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[s] 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).
In reviewing the special master’s decision, determinations of law are reviewed de novo,
Andreu ex rel. Andreu v. Secretary of Health & Human Servs., 569 F.3d 1367, 1373 (Fed. Cir.
2009) (quoting Althen, 418 F.3d at 1278), and findings of fact are reviewed for clear error, id.;
see also Paluck v. Secretary of Health & Human Servs., 786 F.3d 1373, 1378 (Fed. Cir. 2015)
(“[W]e review findings of fact under the arbitrary and capricious standard.”) (citing Griglock v.
Secretary of Health & Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012)); Broekelschen v.
Secretary of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (same) (citing
Capizzano v. Secretary of Health & Human Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006)).
Nevertheless, “a deferential standard of review ‘is not a rubber stamp.’” Paluck v. Secretary of
Health & Human Servs., 113 Fed. Cl. 210, 224 (2013), aff’d, 786 F.3d 1373 (Fed. Cir. 2015)
17Further citations to the transcript of the hearing on the Whitneys’ Motion to Review
will be cited as “Hr’g Tr. __.”
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(quoting Porter v. Secretary of Health & Human Servs., 663 F.3d 1242, 1255-56 (Fed. Cir. 2011)
(O’Malley, J., concurring in part and dissenting in part)). The special master must “consider[]
the relevant evidence of in the record as a whole, draw[] plausible inferences and articulate[] a
rational basis for the decision.” Hines ex rel. Sevier v. Secretary of the Dep’t of Health &
Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991); see also 42 U.S.C. § 300aa-13(b)(1)
(“[T]he special master or court shall consider the entire record and the course of the injury,
disability, illness, or condition until the date of the judgment of the special master or court.”).
And, while the special master need not address every individual piece of evidence presented in
the case, see Doe v. Secretary of Health & Human Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010),
the special master may not 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 Hirmiz v. Secretary of Health & Human
Servs., 119 Fed. Cl. 209, 216 (2014), appeal pending, No. 2015-5043 (Fed. Cir.).
ANALYSIS
Congress adopted the Vaccine Act 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. A Vaccine Injury Table was originally established to provide an
expeditious means of compensating children and others who suffer vaccine related injuries.
Loving ex rel. Loving v. Secretary of Dep’t of Health & Human Servs., 86 Fed. Cl. 135, 141
(2009).18 For “Table injuries,” causation is conclusively presumed if a petitioner’s vaccine and
subsequent injury, or significantly aggravated condition, are listed on the Vaccine Injury Table.
See 42 U.S.C. § 300aa-11(c)(1)(C)(i); see also Hirmiz, 119 Fed. Cl. at 216. For “off-Table
injuries,” i.e., injuries or significantly aggravated conditions not found on the Vaccine Injury
Table, the petitioner must prove causation in fact by preponderant evidence. 42 U.S.C.
§§ 300aa-11(c)(1)(C)(ii), -13(a)(1)(A); see also Hirmiz, 119 Fed. Cl. at 216.
Causation in fact is demonstrated by a petitioner who satisfies each of the three Althen
factors by preponderant evidence. Althen, 418 F.3d at 1278 (quoted supra, at 9). The Federal
Circuit has emphasized 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 and internal quotations
omitted); see also Paluck ex rel. Paluck v. Secretary of Health & Human Servs., 104 Fed. Cl.
457, 470 (2012) (“[A] reliable theory of causation must be shown to be applicable to the facts of
the particular case at hand.”). For each Althen prong, “[e]vidence . . . may overlap with and be
used to satisfy another prong.” Hopkins ex rel. Hopkins v. Secretary of Dep’t of Health &
18First put in place via statutory enactment, 42 U.S.C. § 300aa-14(a), the Vaccine Injury
Table has been periodically revised pursuant to notice-and-comment rulemaking under the
statutory authority of 42 U.S.C. § 300aa-14(c). The current version of the Vaccine Injury Table,
as amended, is set forth at 42 C.F.R. § 100.3.
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Human Servs., 84 Fed. Cl. 517, 523 (2008). After a prima facie case of causation has been made
by the petitioner, “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 (Fed. Cir.
2008) (citation and internal quotation omitted).
The Federal Circuit has repeatedly cautioned that preponderant proof of causation need
not be shown with scientific certainty but rather by a demonstration that the vaccine more likely
than not caused the injury. See Althen, 418 F.3d at 1280 (“[T]he purpose of the Vaccine Act’s
preponderance standard is to allow the finding of causation in a field bereft of complete and
direct proof of how vaccines affect the human body.”); see also Moberly ex rel. Moberly v.
Secretary of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010) (“A petitioner must
provide a reputable medical or scientific explanation that pertains specifically to the petitioner’s
case, although the explanation need only be ‘legally probable, not medically or scientifically
certain.’”) (quoting Knudsen ex rel. Knudsen v. Secretary of Dep’t of Health & Human Servs., 35
F.3d 543, 548-49 (Fed. Cir. 1994)); Andreu, 569 F.3d at 1378 (“Requiring ‘epidemiologic
studies . . . or general acceptance in the scientific or medical communities . . . impermissibly
raises a claimant’s burden under the Vaccine Act.’”) (alteration in original) (quoting Capizzano,
440 F.3d at 1325-26).19 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.” Knudsen, 35 F.3d at 549 (citing Jay v. Secretary of
the Dep’t of Health & Human Servs., 998 F.2d 979, 984 (Fed. Cir. 1993)). Nonetheless, this
standard for proving causation is not to be confused with a standard requiring only “possible” or
“plausible” causation. See Moberly, 592 F.3d at 1322.
In proving causation, the special master 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 turn citing
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993))). In addition, the special master
may consider medical literature or epidemiological evidence in reaching an informed judgment
as to whether a particular vaccine inoculation caused a subsequent injury or significantly
aggravated condition. See LaLonde v. Secretary of Health & Human Servs., 746 F.3d 1334,
1339-40 (Fed. Cir. 2014).
Here, S.W.’s transverse myelitis is not listed on the Vaccine Injury Table. Therefore, the
Whitneys must prove causation by preponderant evidence under the three-prong test set forth in
Althen. To this day, it has not been established with scientific certainty whether a vaccine, virus,
or other infectious agent caused S.W.’s transverse myelitis. See supra, at 7. Accordingly,
indirect and circumstantial evidence of cause and effect is quite important to this case. And,
while the present dispute concerns only the special master’s application of the second prong of
19The requirement for preponderant evidence originates from the Vaccine Act itself:
“Compensation shall be awarded . . . to a petitioner . . . [who] has demonstrated by a
preponderance of the evidence the matters required in the petition by [42 U.S.C. § 300aa-
11(c)(1)].” 42 U.S.C. § 300aa-13(a)(1); see also Althen, 418 F.3d at 1279 & n.6.
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the Althen framework, the evidence related to the first and third prongs is pertinent to an analysis
of the issues raised with regard to prong two.
I. Althen’s First Prong: A Theory Connecting Vaccine and Injury
With regard to Althen’s first prong, the special master assumed that the Whitneys had met
their burden of proof because they had presented a plausible medical theory to explain how
vaccinations can cause transverse myelitis. The special master’s conclusion regarding prong one
is adequately supported by both the facts and the record. Through expert testimony and medical
literature, the Whitneys have demonstrated a biologically persuasive medical theory connecting
S.W.’s vaccinations, particularly the DTaP vaccine, to transverse myelitis.
Dr. Shafrir explained that there are “different pathophysiologic mechanism[s] of how
[transverse myelitis] occur[s]” and that “[w]e see an immune stimulation, other infection, or
immunizations, and this creates an autoimmune reaction, which can be of different pathways.”
Tr. 16:10-16 (Shafrir).20 To explain the potential immunological pathways by which
vaccinations may induce autoimmunity and trigger the onset of transverse myelitis, Dr. Shafrir
pointed to a scientific article that discussed “[t]he mechanisms by which vaccines may induce
[transverse myelitis].” Pet’rs’ Ex. 16, at Tab D (N. Agmon-Levin, S. Kivity, M. Szyper-Kravitz,
& Y. Shoenfeld, Transverse myelitis and vaccines: a multi-analysis, 18 Lupus 1198-04 (2008)
(“Agmon-Levin study”)). The Agmon-Levin study outlined three pathways:
The host’s response to a vaccine, originally generated to produce
protective immunity, is similar to its response to an infectious
invasion. Therefore, it is reasonable to assume that as infectious
agents can induce autoimmunity, so can the recombinant or live
attenuated antigens used for vaccination. Several mechanisms by
which an infectious antigen may induce autoimmunity have been
defined.
 Molecular mimicry between infectious antigens and self antigens is
the most common mechanism.
 Epitope spreading, whereby invading antigens accelerate an
ongoing autoimmune process by local activation of antigen
presenting cells and over processing of antigens is another
mechanism.
 Infectious agents, may induce autoimmunity via polyclonal
activation of B lymphocytes or bystander activation which
enhances cytokine production and further induce the expansion of
auto reactive T-cells. The latter mechanism may be associated with
post-infectious TM [transverse myelitis,] as IL-6 [inflammatory
20An autoimmune reaction is “characterized by a specific humoral or cell-mediated
immune response against constituents of the body’s own tissues (self antigens or autoantigens).”
Dorland’s at 183.
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marker] levels were found to be markedly elevated in the
[cerebrospinal fluid] of TM patients.
Id. (emphasis in original); see also Tr. 23:21 to 24:16 (Shafrir).21
Building upon Dr. Shafrir’s testimony, Dr. Oleske provided an immunological
explanation as to how a vaccine can induce transverse myelitis. See Tr. 333:3 to 335:23 (Oleske)
(testifying that vaccines can cause transverse myelitis through a cytokine response and stating
that “[S.W.], unfortunately, was one of those rare individuals . . . [whose] . . . immunological
response[] caused the transverse myelitis”). Dr. Oleske opined that “the multiple bacterial
and viral antigens of childhood vaccines, most often with an adjuvant used to stimulate an
immune and cytokine response, can be an extrinsic factor in adverse reactions to childhood
immunizations such as the [t]ransverse [m]yelitis . . . experienced by S.W.” Pet’rs’ Ex. 20, at 1
(Supplemental Medical Expert Report of Dr. James Oleske (Jan. 7, 2014)). According to
Dr. Oleske, his theory was consistent with the bystander activation theory outlined in the
Agmon-Levin study. Tr. 337:4 (Oleske).
Notably also, several scientific publications identify the onset of transverse myelitis after
vaccinations. In a case series from the Johns Hopkins University Hospital and Kennedy Krieger
Institute, researchers collected clinical data from 47 patients between January 2000 and February
2004 who met the criteria for acute or remote transverse myelitis and were under the age of 18.
Pet’rs’ Ex. 16, at Tab G (F.S. Pidcock, C. Krishnan, T.O. Crawford, C.F. Salorio, M. Trovato, &
D.A. Kerr, Acute transverse myelitis in childhood: Center-based analysis of 47 cases, 68
Neurology 1474-80 (May 1, 2007) (“Johns Hopkins Case Series”).22 In 28% of those cases (13
out of 47 children), the patient had received vaccinations or an allergy shot within 30 days of the
first symptom of transverse myelitis. Id. at 1476. The immunizations that were administered
included, inter alia, polio, hepatitis B, diphtheria-tetanus-pertussis, and Haemophilus influenzae.
Id.; see also Pet’rs’ Ex. 16, at 18 (Medical Expert Report of Yuval Shafrir, M.D. (Feb. 22,
2013)). In two cases, the patient had received a combination of three immunizations. Johns
Hopkins Case Series at 1476. Antecedent immunizations and illness were documented in eight
cases. Id. Because 28% of patients reported an immunization 30 days prior to the onset of
symptoms, the authors addressed a “potential causal link” between vaccinations and transverse
myelitis, commenting that “the large fraction of younger children affected, the current
recommended vaccination schedule for children, and the lack of any single vaccine association
within this group all undermine a potential cause link between vaccination and [acute transverse
21Dr. Wiznitzer, “who appears regularly for the [g]overnment in Vaccine Act cases,”
Santini v. Secretary of Health & Human Servs., __ Fed. Cl. __, __, No. 06-725V, 2015 WL
4077254, at *6 (Fed. Cl. June 30, 2015), opined that molecular mimicry, epitope spreading, and
bystander activation “have a basis in reality,” Tr. 218:19-24 (Wiznitzer), “[w]hen it comes to an
infection, [but] not to a vaccine,” Tr. 237:14-18 (Wiznitzer).
22The eligible patients for the case series had been evaluated at the Johns Hopkins
Transverse Myelitis Center (“JHTMC”). Johns Hopkins Case Series at 1475. The JHTMC is
“dedicated to the diagnosis, clinical management and research of transverse myelitis.” Johns
Hopkins Medicine, The Transverse Myelitis Center, available at http://www.hopkinsmedicine.
org/neurology_neurosurgery/centers_clinics/transverse_myelitis/.
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myelitis.]”. Id. at 1479. According to Dr. Shafrir, the authors’ comment was “unfounded”
because their data are “statistically significant.” Pet’rs’ Ex. 16, at 18; see also Tr. 42:25, 41:6-7
(“We’re talking about a quarter of the series, which is a . . . very high number.”). Dr. Shafrir
testified that the researchers may have been “shocked by the number” and were concerned about
the “hot potato” that is vaccine politics. Tr. 41:4-5, 43:1 (Shafrir). Other case studies have also
documented transverse myelitis after vaccinations containing tetanus, diphtheria, and acellular or
cellular pertussis. See, e.g., Pet’rs’ Ex. 16, at Tab J (RMS Riel-Romero, Acute transverse
myelitis in a 7-month-old boy after diphtheria-tetanus-pertussis immunization, 44 Spinal Cord
688-91 (2006)), Tab K (Naser U.A.M.A. Abdul-Ghaffar & K.N. Achar, Brown-Sequard
Syndrome following Diphtheria and Tetanus Vaccines, 74 Trop. Doct. 74-75 (1994)), & Tab M
(E. Whittle & N.R. Robertson, Transverse myelitis after diphtheria, tetanus, and polio
immunization, Br. Med. J. 1450 (June 4, 1977)).
Even though the foregoing case studies and the Johns Hopkins Case Series are not
definitive “proof of causality,” Tr. 54:18-19 (Shafrir); see also Tr. 168:6 to 168:22 (Wiznitzer),
the John Hopkins Case Series and other case studies demonstrate an “association” between
vaccines and the disorder. Pet’rs’ Ex. 16, at 20. Given the detailed explanation of the
mechanisms through which vaccines can cause transverse myelitis and the circumstantial
evidence from the case reports, Dr. Shafrir concluded that S.W.’s immunizations were “by far
the most likely cause for [S.W.’s] transverse myelitis.” Tr. 34:3-4 (Shafrir); see also Pet’rs’ Ex.
16, at 21 (“[I]t is much more likely than not that [S.W.]’s transverse myelitis was a result of an
immune process triggered by the vaccination.”). Dr. Oleske agreed. Tr. 337:23-24 (Oleske)
(testifying that S.W.’s vaccinations “more likely than not caused his transverse myelitis”).23
The persuasiveness of this conclusion is bolstered by the admission of the government’s
expert, Dr. Weintzen. When asked about the immune-mediated mechanisms delineated in the
Agmon-Levin study, Dr. Weintzen answered that “all three of these pathophysiologic
approaches would apply equally to vaccine as to infection.” Tr. 570:2-4 (Weintzen) (emphasis
added); see also Tr. 510:17-20 (Weintzen) (“[A]ssuming vaccines do cause [transverse myelitis]
. . . I think there would be no reason to assume that the immune mechanisms would be
different.”). Although Dr. Weintzen ultimately believed that HHV-6 or another virus caused
S.W.’s transverse myelitis, Tr. 502:21 to 503:12 (Weintzen), he acknowledged a “hypothetical,
theoretical possibility that if you studied enough people, maybe you could find that, in fact, the
immune response to a vaccine can do what infections can do,” Tr. 572:11-14 (Weintzen).24 In
23Given the rarity of the disorder in children (about one in a million), “the ability to
perform a prospective epidemiological study, which ideally would follow all the patients who
were immunized and see which of them will develop transverse myelitis, is practically
impossible.” Tr. 22:3-6 (Shafrir). “You [would] have to review . . . three [to] four million
patients.” Tr. 22:6-8 (Shafrir).
24Dr. Weintzen testified that a circumstance in which he would tell a family that a DTaP
vaccine caused transverse myelitis was if “a neurosurgeon went in and biopsied the spinal cord
and a pathologist found pertussis antigen, or tetanus toxoid, or diphtheria toxoid, adherent to
components of his bone marrow.” Tr. 585:6-19 (Weintzen). Although Dr. Weintzen in effect
would have required a showing of causation equivalent to “scientific certainty,” such a
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this respect, Dr. Weintzen joined Drs. Shafrir and Oleske in disagreeing with Dr. Wiznitzer’s
opinion that infections but not vaccines could cause transverse myelitis. See supra, at 14 n.21.
Applying the pertinent evidentiary standard to the foregoing facts, the Whitneys have
established a persuasive “medical theory causally connecting the vaccination and the injury.”
Althen, 418 F.3d at 1278.
II. Althen’s Third Prong: A Proximate Temporal Relationship
For the third prong of Althen, the special master found that the latency period between the
vaccinations and S.W.’s transverse myelitis was appropriate for the appearance of the disorder.
Entitlement Decision at 11-12. The court concurs.
S.W. received the DTaP, Hep B, Hib, PCV, IPV, and rotavirus vaccinations on
November 26, 2007, and seventeen days later, on December 13, 2007, he was hospitalized for
neurological problems. See supra, at 3. All four experts who testified at the entitlement hearings
agreed that S.W. had been experiencing symptoms of his transverse myelitis as early as seven to
ten days before this initial hospitalization. Tr. 65:12-24 (Shafrir) (testifying that S.W.’s first
symptom of transverse myelitis was most likely constipation, which reportedly began ten days
before his admission to the hospital); Tr. 279:22 to 280:14 (Wiznitzer) (agreeing that S.W. had
some symptoms of transverse myelitis seven to ten days before hospitalization); Tr. 362:1-3
(Oleske) (“[At] seven to [ten] days, . . . there were probably early symptoms of the onset of the
transverse myelitis.”); Tr. 576:10-11 (Weintzen) (“I think the vaccine would be about ten days
before the onset of his constipation.”). Experts for both parties also testified that the temporal
relationship between the vaccinations and the manifestation of S.W.’s transverse myelitis was
medically appropriate. See, e.g., Tr. 33:1-7 (Shafrir) (testifying that the onset of S.W.’s
transverse myelitis was at an appropriate time for causation); Tr. 576:2-6 (Weintzen) (“Both the
vaccine and the respiratory infection at about Thanksgiving fall in perfect timing for what you
would expect for an immune system event to have been begun by that antigenic stimulation, on
either . . . side of the equation.”); see also Entitlement Decision at 11-12. The medical literature
provided by the Whitneys supports the testimony of the parties’ experts. See, e.g., Pet’rs’ Ex. 16,
at J (transverse myelitis documented in child who was given DTaP vaccine seventeen days
before he was admitted to hospital, and child was suffering from constipation prior to
admission).
In these circumstances, the Whitneys have established that S.W.’s transverse myelitis
began within an appropriate time after the administration of his vaccinations. See Althen, 418
F.3d at 1278.
III. Althen’s Second Prong: A Logical Sequence of Cause and Effect
The Whitneys raise objections to the special master’s conclusion that they failed to
demonstrate a logical sequence of cause and effect between S.W.’s vaccinations and the
heightened burden of proof in vaccine cases has been rejected by the courts. See, e.g., Moberly,
592 F.3d at 1322.
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transverse myelitis. See Pet’rs’ Mem. at 15-39. Their objections can be grouped into three
categories, namely (1) the support or lack of support for certain inferences drawn by the special
master, (2) the identification of a vaccine cause, or not, by treating physicians, and (3) the
implications of the treatment plan adopted for S.W. after the onset of transverse myelitis.
A. Inferences
As an initial matter, the Whitneys aver that the special master drew wholly impermissible
inferences from the factual record to support his conclusion that they failed to meet their burden
of proof for prong two. Pet’rs’ Mem. at 15-18. At onset of symptoms in December 2007, the
principal treating physician was Dr. Fogg, a pediatric infectious disease specialist. See Hr’g Tr.
6:23 to 7:3 (discussing Dr. Fogg’s role as an infectious disease specialist); see also Hr’g Tr.
22:23 to 23:1 (“Dr. Fogg was the infectious disease specialist who was consulted to try to figure
out what was leading to [S.W.’s condition] or whether there was an infectious disease.”). The
special master in his decision inferred that Dr. Fogg disclosed to the Whitneys that the HHV-6
virus was the causative agent of their son’s transverse myelitis. Entitlement Decision at 18
(“Dr. Fogg, in fact, told the Whitneys that the HHV-6 virus caused their son’s transverse myelitis
orally.”). No direct evidence supported the special master’s factual conclusion.
Dr. Fogg initially listed as possible triggers viral, bacterial, post-vaccination, and
autoimmune causes for S.W.’s condition. Pet’rs’ Ex. 2, at 265. He ordered a polymerase chain
reaction test to detect pathogens in S.W.’s plasma, id. at 265-66, and that test showed evidence
of an HHV-6 infection, id. at 234. Thereafter, he wrote that “[the HHV-6 virus] or his
immunizations could have been the trigger for his ADEM.” Id. at 166. That circumstantial
evidence does not support the special master’s inference. See Hr’g Tr. 14:2-4 (“[T]here is no
record where Dr. Fogg explicitly says the HHV-6 vaccine was the cause of S.W.’s transverse
myelitis.”). Other circumstantial evidence points to a contrary conclusion. In February 2008,
two months after S.W.’s hospitalization, S.W. saw a urologist, Dr. Roelof, who took a history
from Ms. Whitney. Dr. Roelof reported that Ms. Whitney “state[d] that they thought [S.W.] had
acute viral myelitis secondary to a virus or perhaps from his vaccination. Pet’rs’ Ex. 4, at 17.
And, notably, the Whitneys steadfastly refused to allow S.W. to have further vaccinations, a
situation that a rehabilitation specialist, Dr. Rush, found to be problematic because, as he put it,
they were acting “in the misguided belief that immunizations were the cause of [S.W.’s]
myelitis.” Id. Ex. 5, at 328. The Whitneys’ belief had some basis, and nothing in the record
indicates that they were given medical advice to the contrary, from Dr. Fogg or any other treating
physician at the hospital. See Hr’g Tr. 27:18-20 (“[A]t some point the parents reached their own
conclusion that the vaccine was the cause.”).
In short, the special master’s inference about what Dr. Fogg might have told the
Whitneys about causation is wholly unreasonable and lacks credible support in the medical
records. See Paluck, 786 F.3d at 1384-85 (finding that it was arbitrary and capricious for the
special master to make an inference that the treating physician had referred the petitioners to a
neurologist simply because he was “frustrated” with the petitioners).
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B. Medical Records from S.W.’s Treating Physicians
The Whitneys contend that the special master incorrectly weighed certain medical reports
and statements from S.W.’s treating physicians. Pet’rs’ Mem. at 17-26. Essentially, the
Whitneys aver that the special master improperly discounted statements by treating physicians
that pointed to vaccine causation.
1. Medical reports from Dr. Fogg on December 14 & 17, 2007.
Dr. Fogg identified S.W.’s immunizations as a potential cause of his condition. On
December 14, 2007, one day after S.W. was admitted to the hospital, Dr. Fogg stated “that the
patient had his 4-month immunizations on 11/26/07. . . . Possible infectious triggers include
viral[,] . . . bacterial[,] . . . post vaccination reaction, or autoimmune disease . . . . I will report
the possible post immunization adverse event to [VAERS].” Pet’rs’ Ex. 2, at 264-66 (emphasis
added). Three days later, Dr. Fogg stated that “[the HHV-6 virus] or his immunizations could
have been the trigger . . . .” Id. Ex. 2, at 166 (emphasis added). The special master considered
these medical records to be “weak pieces of evidence.” Entitlement Decision at 16.25 He
concluded that “a treating doctor’s inclusion of a vaccine as a possible cause [did] not materially
support the petitioners’ argument.” Id.
The Whitneys contend that the special master had no reasonable justification in
discounting the significance of Dr. Fogg’s medical notes. Pet’rs’ Mem. at 19-20. To support
their argument, the Whitneys rely on the Federal Circuit’s recent decision in Paluck, 786 F.3d
1373. In Paluck, the court of appeals held that petitioners “were entitled to rely on the
statements from [their child’s] physicians that his condition could be due to a ‘toxic . . . event’ as
evidence supporting a causal nexus between [his] vaccinations and his subsequent neurological
regression.” 786 F.3d at 1385 (emphasis added). The government counters that the circum-
stances here are different from those in Paluck because the special master in this case did not
disregard any probative medical statements. Resp’t’s Mem. at 7-8. The government argues that
in this instance, the evidence was insubstantial because Dr. Fogg listed “post vaccination
reaction” as a “possible” cause, not a probable or likely one. Id. at 8. The government therefore
contends that the special master’s application to this record evidence was “perfectly reasonable.”
Id.
The government’s argument is not persuasive. Dr. Fogg was most directly responsible
for diagnosing S.W.’s condition at onset and making recommendations for testing and for S.W.’s
treatment immediately upon the child’s admission to the hospital. See Pet’rs’ Mem. Ex. 2, at
264-66; see also Hr’g Tr. 6:23 to 7:3. Dr. Fogg was in the “best position to determine whether a
logical sequence of cause and effect show[ed] that the vaccination was the reason for the injury.”
Andreu, 569 F.3d at 1375 (citations and internal quotations omitted); see also Moberly, 592 F.3d
25The special master’s treatment of these medical records is inconsistent. While
classifying the evidence as “weak,” he also relied on the same records as “foundational points”
for drawing the inference that Dr. Fogg informed the Whitneys that the HHV-6 virus caused their
son’s transverse myelitis. See supra, at 17.
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at 1323.26 While Dr. Fogg initially used the word “possible” when describing vaccine causation,
he coupled his initial diagnosis with the annotation that he would report this possibility to
VAERS. Pet’rs’ Mem. Ex. 2, at 265-6. The willingness of an infectious disease specialist to file
a VAERS report at the onset of a child’s symptoms is relevant evidence of causation. The
special master erred by neglecting to consider this probative piece of evidence. Cf. Dobrydnev v.
Secretary of Health & Human Servs., 566 Fed. Appx. 976, 984 (Fed. Cir. 2014), reh’g denied,
(Aug. 20, 2014), cert. denied, 135 S. Ct. 1560 (2015) (finding that the special master was not
required to give weight to a VAERS report filed 30 months after a vaccination when the
pediatrician who filed the report “[was] not an expert in [the] field,” and had “explicitly
defer[red] to the expert whose opinion ha[d] been rejected”).27
2. Medical report from Dr. Rush on February 22, 2008.
In a report from February 22, 2008, two months after the onset of S.W.’s condition,
Dr. Rush recommended that S.W. receive additional vaccinations. Dr. Rush indicated that he did
“not have any reason to believe . . . [that] immunizations were the cause of [S.W.’s] myelitis . . .
nor d[id] [he] believe literature would [bear] that out.” Pet’rs’ Mem. Ex. 5, at 328. The special
master described this statement as “remarkably strong and direct” evidence and stated that
Dr. Rush’s “recommendation for additional vaccinations, which would include additional doses
of the DTaP vaccine, further demonstrates his conviction that the vaccines did not harm [S.W.].”
Entitlement Decision at 17. The special master further noted that the Whitneys had not
challenged Dr. Rush’s qualifications to opine about causation and concluded that Dr. Rush was
“an unbiased and qualified doctor” since he “discounted the vaccinations as a cause for myelitis
without referring to the HHV-6 virus.” Id. at 17-18.
The Whitneys challenge the special master’s assessment of Dr. Rush’s commentary for
two main reasons. Pet’rs’ Mem. at 18 n.25. First, the Whitneys suggest that Dr. Rush was not
26In addition to Dr. Fogg, S.W. was seen during his hospitalization by at least one
neurologist. A neurologist made a handwritten sequacious annotation: “HHV-6 associated
myelitis.” Pet’rs’ Ex. 2, at 182. The special master considered that this note by a neurologist
was “ambiguous as to whether the doctor was stating that the virus caused the myelitis or the
virus simply preceded the myelitis.” Entitlement Decision at 17 n.17. However, he considered
the doctor’s later comment, “HHV[-]6 myelitis,” to be an indication of “a causal (as opposed to
simply temporal) relationship.” Id.; see also Pet’rs’ Ex. 2, at 182, 186.
27Relatedly, the Whitneys dispute the special master’s conclusion that they failed to
“identif[y] even one medical record in which a treating doctor expressed the opinion that a
vaccination caused the transverse myelitis.” Entitlement Decision at 18-19 (emphasis added).
The special master’s determination is captious and untenable with respect to the evidence in the
record as a whole. See 42 U.S.C. § 300aa-13(a)(1). Certainly Dr. Fogg’s consideration that
S.W.’s vaccinations may have been a cause of his transverse myelitis and his decision to report
the adverse event to VAERS counts as “one medical record” expressing an opinion in support of
vaccine causation. See Pet’rs’ Ex. 2, at 166, 264-66; see also Pet’rs’ Mem. at 30 (citing a total of
six medical records from S.W.’s treating physicians that support a nexus between S.W.’s
vaccinations and subsequent transverse myelitis).
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qualified to render an opinion on causation. Dr. Rush is a medical doctor who specializes in
rehabilitation, see supra, at 6 n.11. He neither examined S.W. upon his admission to the hospital
nor was he involved in diagnosing S.W.’s condition or determining his initial treatment. Rather,
as a physiatrist, his services were aimed at the amelioration of symptoms and complications of
the disorder. See Pet’rs’ Ex. 5, at 325-29. His remarks about vaccine causation are far less
credible than the annotations made by Dr. Fogg, the infectious disease specialist who initially
treated S.W., or the opinions of the neurologists who testified as experts at the Entitlement
Hearing. That said, the Whitneys’ expert neurologist, Dr. Shafrir, described Dr. Rush’s report as
“extensive and thoughtful.” Id. Ex. 16, at 11. In addition, Dr. Rush correctly reasoned that S.W.
met the criteria for transverse myelitis, not ADEM. Id. Ex. 5, at 328 (“Please note that I do not
technically agree with the diagnosis of ADEM.”). Second, the Whitneys suggest that Dr. Rush’s
assessment was flawed due to his pro-vaccination point of view. Pet’rs’ Mem. at 18 n.25. As
shown in the medical report, Dr. Rush regretted his failure to address the issue of vaccination
when he met with S.W.’s parents because it was “incredibly important that like any other child,
[S.W.] get his immunizations.” Pet’rs’ Ex. 5, at 328 (emphasis added). Dr. Rush’s notes are
relevant evidence to be considered as part of the record as a whole, evaluated in light of his
medical background and focus and his evident emphasis on vaccinations notwithstanding
contraindications. See 42 U.S.C. § 300aa-13(a)(1).
3. Medical reports signed by Dr. DeRoos on February 17, 2008 and Dr. Rush on July
14, 2010.
A report was prepared by a nurse practitioner, Ms. Shelanskey, on February 17, 2008,
about two months after S.W.’s admission to the hospital. Pet’rs’ Ex. 6, at 44. The report
addressed S.W.’s past history, discussed exam findings, and provided an assessment. Id. The
report noted that an infectious disease specialist, not named, had identified the HHV-6 virus as
the cause of S.W.’s condition. Id. (“Infectious Disease was able to identify the HHV-6 virus as
the causative agent.”). A neurologist, Dr. DeRoos, signed the report indicating that he agreed
with the nurse practitioner’s assessment. Id. The special master acknowledged that there was “a
degree of hearsay” in this statement; there was no record evidence that an infectious disease
specialist had established that a virus triggered S.W.’s transverse myelitis. Entitlement Decision
at 17. Regarding this report, Dr. Shafrir testified that “obviously[] the statement . . . is incorrect
[because Dr. Fogg] said either the vaccination or the HHV-6 [virus was the causative agent],
after the diagnosis of HHV-6 was known already.” Tr. 122:11-13 (Shafrir); see also Tr. 163:14-
17 (Wiznitzer) (“Yes, they did [consider the vaccines as a potential cause]. It was in the initial
notes that were there, that was a question that was raised.”); Tr. 329:6-11 (Oleske) (testifying
that Dr. Fogg never identified the sole cause of S.W.’s disorder and that the medical workup
“would not have allowed [the doctors] to come up with a sole cause.”). The special master
entirely overlooked expert testimony on this point. Instead, he found that the post-hospitali-
zation Shelanskey-DeRoos report had “some value as evidence that the treating doctors did not
consider the vaccine to be causative.” Entitlement Decision at 17-18.28
28The special master improperly applied the same circumstantial evidence to credit this
record as he did to infer that Dr. Fogg had spoken with the Whitneys to inform them that the
20

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A report drafted by an occupational therapist, Ms. Gora, on July 14, 2010 evaluated
S.W.’s mobility, seating, and ability of transfer, and it included the therapist’s recommendation
that S.W. begin using a particular type of wheelchair. Pet’rs’ Ex. 5, at 380-83. Important to
this dispute, the first page of the document listed S.W.’s diagnosis as a “Reaction to an
Immunization,” and the last page was signed by Dr. Rush, who “concur[red]” with the
occupational therapist’s recommendation. Id. Ex. 5, at 380, 383. Although Dr. Rush signed this
report that identified S.W.’s condition as vaccine-induced, the special master did not afford this
piece of evidence any importance because it came over two years after Dr. Rush’s rehabilitative
assessment in February 2008, and it was “very unlikely that Dr. Rush changed his assessment of
the cause of [S.W.’s] transverse myelitis.” Entitlement Decision at 7 n.11; see also id. at 15. To
support this conclusion, the special master relied on the Whitneys’ own expert, Dr. Shafrir, who
“did not accept this relatively ministerial act as an expression of Dr. Rush’s views on the role
vaccinations played in [S.W.]’s illness.” Entitlement Decision at 15 (citing Tr. 126 to 128
(Shafrir)). Indeed, Dr. Shafrir testified that he did not “think that we should look at [this
document] as a determination of a diagnosis” because its purpose was to “get the child a
wheelchair.” Tr. at 127:12-15 (Shafrir). Similarly, the government’s expert, Dr. Wiznitzer,
testified that he suspected that Dr. Rush “[did]n’t even look at the first page [of the report],” but
simply signed the document because S.W. needed the wheelchair “irrespective of what the
diagnosis [wa]s.” Tr. 164:21 to 165:9 (Wiznitzer).
The Whitneys fault the special master for crediting the post-hospitalization Shelanskey-
DeRoos report while “wholly discount[ing]” the later Gora-Rush report. Pet’rs’ Mem. at 21-26.
The Whitneys argue that “if the special master purports to use expert testimony to discount
medical records helpful to petitioners, he should do so for all records in question.” Id. at 26.
And, indeed, the special master credited the Shelanskey-DeRoos report despite the “level of
hearsay” within the report, which hearsay was contraindicated by other portions of the medical
record, while relying on expert testimony to discredit the Gora-Rush report that supported the
Whitneys’ theory of vaccine causation. Entitlement Decision at 15-17. The Whitneys claim that
“[i]t is clear that the special master desired a certain result, and misconstrued the evidence in
order to reach that result.” Pet’rs’ Mem. at 26. There are indicia that the special master did what
the Whitneys claim, but the dispute over the special master’s treatment of the Shelanskey-
DeRoos and the Gora-Rush reports focuses on records generated in both instances after diagnosis
and testing, and this in a sense constitutes an argument over evidence secondary to the treating
physicians’ contemporaneous notes.
C. S.W.’s Treatment Plan
The medical records reveal that S.W. was initially treated with high-dose steroids, not
anti-viral drugs. Pet’rs’ Ex. 2, at 264 & 266. The Whitneys argue that S.W.’s treatment course
of steroids is salient evidence that “[S.W.] was experiencing an inflammatory, immune-mediated
process.” Pet’rs’ Mem. at 26-28. They contend that the special master abused his discretion by
failing to consider this treatment plan as evidence in support of vaccine causation. Id.
HHV-6 virus triggered S.W.’s condition. See supra, at 17; see also Entitlement Decision at 17-
18.
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Contrary to the Whitneys’ contention, the special master did consider S.W.’s treatment
plan, acknowledging that there was a dispute among the testifying experts “whether [S.W.’s]
doctors responded appropriately to the [HHV-6] positive PCR test.” Entitlement Decision at 5
n.6. He concluded that “this issue is extraneous to determining whether the vaccines caused
[S.W.]’s transverse myelitis,” reasoning that, as Dr. Weintzen testified, steroid therapy is a
proper treatment for either an immune-mediated reaction to vaccines or an immune-mediated
reaction to a prior infection with the HHV-6 virus. Id.; see Tr. 501:10 to 502:20 (Weintzen)
(discussing steroid treatment to prevent nerve tissue damage in the spinal cord by minimizing an
immune response); see also Resp’t’s Mem. at 13-14. When S.W. was admitted to the hospital,
he was in the “convalescent phase” of the HHV-6 infection. See Tr. 499:25, 501:19 to 502:12
(Weintzen) (indicating that the HHV-6 infection was convalescing based on the number of
copies of viral DNA found in S.W.’s plasma). In essence, there were viral particles in S.W.’s
blood, but his immune system had responded to the infection. Tr. 494:15-24, 593:24 to 594:2
(Weintzen) (“[S.W.] was in the recovery stage of his HHV-6 [infection] clearly.”); see also Hr’g
Tr. 31:12-14 (“[H]is immune system had kicked in and was starting to fight off the virus.”).29
Dr. Weintzen testified that he would not have ordered anti-viral drugs at that point in time
because S.W.’s “immune system [had] already responded” to clear the virus. Tr. 578:4-12
(Weintzen). However, a powerful anti-inflammatory medication, such as steroid therapy, would
suppress an immune-mediated reaction and prevent injury to S.W.’s spinal cord, regardless of the
trigger.
The Whitneys disregard Dr. Weintzen’s testimony and rely on the testimony of
Dr. Wiznitzer, who opined “that if [S.W.] had a direct viral myelitis with HHV-6, [he] would
worsen before he got better if he did not receive the anti[-]viral medication.” Pet’rs’ Mem. at 27
(emphasis added) (citing Tr. 281:23 to 282:1 (Wiznitzer)). The Whitneys further rely on the
testimony of Dr. Oleske, who testified that treatment of high-dose steroids is an “indication that
the treating physicians and specialists that were seeing [S.W.] certainly didn’t consider this an
active HHV-6 infection, otherwise they would have treated him with anti[-]viral drugs and been
cautious with high-dose steroids.” Tr. 325:14-21 (Oleske). As discussed above, the steroid
treatment only proves that S.W.’s doctors thought he was having an immune-mediated reaction.
It “says nothing about what triggered it.” Resp’t’s Mem. at 16; see also Hr’g Tr. 18:2-7
(conceding that it was “correct” that the steroid treatment was ambiguous as to cause).
As a result, the testimony about treatment is not particularly helpful either to prove or
disprove a vaccine cause. Among other things, the HHV-6 virus did not directly invade S.W.’s
spinal cord, thereby causing inflammation. Entitlement Decision at 12-13 (“[L]ittle evidence
supports a direct invasion theory”); see also Tr. 501:23 to 502:1 (Weintzen) ([I]t’s not active . . .
virus growing in the spinal cord, it’s the immune response that somehow as an innocent
bystander hurt[s] an organ of the body, in this case the spinal cord.”). Rather, as discussed
29In the case of HHV-6, “before the immune response [is triggered],” the virus initially
has an “unrestricted capability of growing.” Tr. 500:7-9 (Weintzen). The convalescent phase
refers to the later stage of the infection when the “immune response [has] mature[d] more,” thus
inhibiting viral replication “so that . . . over time the concentration of virus in blood drops.” Tr.
500:13-18 (Weintzen).
22

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supra, either a post-vaccination event or the HHV-6 virus led to S.W.’s transverse myelitis by
triggering autoimmunity. See Entitlement Decision at 13; see also Agmon-Levin study
(outlining three pathways that induce autoimmunity). Accordingly, “it was reasonable for the
[s]pecial [m]aster to conclude that he could not draw any inferences about causation from
[S.W.]’s treatment.” Resp’t’s Mem. at 14.
IV. Synopsis
With regard to prongs 1 and 3 of the Althen framework, the special master properly
weighed the evidence of record and made determinations in accord with law. Petitioners
prevailed on those prongs. When analyzing the second prong of Althen, however, the special
master made findings and conclusions that were contrary to the evidence of record and thus were
arbitrary, capricious, and an abuse of discretion. The special master drew the unsupported and
impermissible inference that Dr. Fogg informed the Whitneys that only the HHV-6 virus, and not
the vaccinations, triggered their son’s transverse myelitis. The special master also committed
error when he discounted the diagnostic medical reports by Dr. Fogg and stated that the
Whitneys had not produced even one medical record to support a nexus between S.W.’s
transverse myelitis and the administration of the vaccines. Finally, the special master acted
arbitrarily and capriciously by overly crediting the post-hospitalization Shelanskey-DeRoos
report that contained hearsay not otherwise supported by the medical records, while discrediting
the Gora-Rush report. The special master nonetheless was on a solid footing in determining that
evidence regarding S.W.’s steroid therapy was not particularly helpful on the issue of causation.
CONCLUSION
For the reasons stated, the Whitneys’ motion for review is GRANTED, the special
master’s decision of May 8, 2015 denying compensation is VACATED, and the case is
REMANDED to the special master for further proceedings. The court sets aside the findings of
the special master as to prong 2 of Althen, but makes no affirmative findings of its own.
In this instance, the respective burdens of proof and persuasion to be borne by the parties
may become critical to the outcome. There is the distinct possibility that the Whitneys have, or
will establish on remand, a prima facie case of causation under the Vaccine Act. The
government can overcome the prima facie case by showing by preponderant evidence that
S.W.’s condition “is due to factors unrelated to the administration of the vaccine.” Deribeaux ex
rel. Deribeaux v. Secretary of Health & Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013);
see also de Bazan, 539 F.3d at 1352. It therefore may be incumbent upon the special master
explicitly to consider whether the Whitneys have made a prima facie showing, and, if so, then
whether the government can by a preponderance of the evidence demonstrate that S.W.’s
transverse myelitis was caused by the HHV-6 infection, a factor unrelated to vaccination. See 42
U.S.C. §§ 300aa-13(a)(1)(A)-(B).
This may well be a case in which it is appropriate to obtain testimony from Dr. Fogg and
other physicians who treated S.W. upon hospitalization, to gain a better understanding of the
23

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most relevant medical records.30 Correlatively, one or both of S.W.’s parents might testify as to
what, if anything, Dr. Fogg told them at the time of his diagnosis.
It is so ORDERED.
s/ Charles F. Lettow
Charles F. Lettow
Judge
30The Federal Circuit has commented that
[i]n most instances, however, it is both inadvisable and unnecessary
to subpoena the testimony of treating physicians. It would not be in
the public interest for the specter of a subpoena to provide physicians
with a disincentive to treat a vaccine-injured patient or to cause them
to be less than forthright in creating medical records assessing
the relationship between a vaccine and a patient’s injury. The
submitted documentary evidence can, under most circumstances,
provide adequate insight into the medical opinions of treating
physicians, and there is little need to subject them to cross-
examination in federal court.
Andreu, 569 F.3d at 1383 (citing Cucuras v. Secretary of Health & Human Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993)). This appears to be the exceptional case. The special master
apparently considered that possibility in asking the parties “whether information[, i.e.,
testimony,] should be sought from [S.W.’s] treating doctors.” Entitlement Decision at 18 n.18.
24

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DOCUMENT 3: USCOURTS-cofc-1_10-vv-00809-2
Date issued/filed: 2015-12-16
Pages: 11
Docket text: PUBLIC DECISION (Originally filed: 12/1/2015) regarding 143 DECISION Stipulation/Proffer. Signed by Special Master Christian J. Moran. (SP) Copy to parties. (Additional attachment(s) added on 1/5/2016: #1 Stipulation/Proffer) (jt1). Modified on 7/9/2019 to include the attachment(s) in the main document for posting to the courts website (da).
--------------------------------------------------------------------------------
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In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
REBECCA WHITNEY and *
RANDALL WHITNEY, parents of * No. 10-809V
S.W., a minor, * Special Master Moran
*
Petitioners, * Filed: December 1, 2015
*
v. * Stipulation; diphtheria- tetanus
* pertussis (“DTaP”); Haemophilus
* influenzae type b (“Hib”); inactivated
SECRETARY OF HEALTH * polio (“IPV”); pneumococcal
AND HUMAN SERVICES, * conjugate (“PCV”); rotavirus
* vaccines; acute disseminated
Respondent. * encephalomyelitis (“ADEM”).
* * * * * * * * * * * * * * * * * * * * *
Ronald C. Homer, Conway, Homer & Chin-Caplan, P.C., for Petitioners;
Lara A. Englund, United States Dep’t of Justice, Washington, DC, for Respondent.
UNPUBLISHED DECISION1
On May 29, 2015, respondent filed a joint stipulation concerning the petition
for compensation filed by Rebecca and Randall Whitney, on behalf on their minor
child S.W., on November 22, 2010. The petitioners seek compensation for injuries
allegedly related to S.W.’s receipt of the diphtheria-tetanus-pertussis (“DTaP”)
vaccine, Haemophilus influenzae type b (“Hib”), inactivated polio (“IPV”),
pneumococcal conjugate (“PCV”), and rotavirus vaccines which are contained in
the Vaccine Injury Table (the “Table”), 42 C.F.R. §100.3(a), and which he
received on March 20, 2012, causing him to suffer acute disseminated
encephalomyelitis (“ADEM”). Petitioners further allege that S.W. suffered the
residual effects of this injury for more than six months. Petitioners represent that
1 The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,
2002), requires that the Court post this decision on its website. Pursuant to Vaccine Rule 18(b),
the parties have 14 days to file a motion proposing redaction of medical information or other
information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special
master will appear in the document posted on the website.

Case 1:10-vv-00809-CFL Document 150 Filed 12/16/15 Page 2 of 11
there has been no prior award or settlement of a civil action for damages on her
behalf as a result of her condition.
After a hearing, the undersigned determined that petitioners had failed to
prove that the vaccines S.W. received caused his transverse myelitis. See decision,
issued May 8, 2015, 2015 WL 4537210. On review, the Court vacated that
decision and remanded the case for further proceedings. Opinion and Order, 122
Fed. Cl. 297 (Fed. Cl. 2015).
After remand, the respondent maintains that the vaccines did not cause
S.W.’s transverse myelitis or any other injury.
Nevertheless, the parties agree to the joint stipulation, attached hereto as
“Appendix A.” The undersigned finds said stipulation reasonable and adopts it as
the decision of the Court in awarding damages, on the terms set forth therein.
Damages awarded in that stipulation include:
a. A lump sum of $150,000.00 in the form of a check payable to
petitioners as guardian(s)/conservator(s) of the estate of S. W. No
payments shall be made until petitioners provide respondent with
documentation establishing that they have been appointed as the
guardian(s)/ conservator(s) of S.W.’s estate. This amount represents
compensation for all damages that would be available under 42
U.S.C. § 300aa-15(a).
b. A lump sum payment of $10,971.12, which amount represents
reimbursement of a lien for services rendered on behalf of S.W., in
the form of a check payable jointly to petitioners and
State of Michigan
State of Michigan Estate Recovery Program
P.O. Box 30053
Lansing, MI 48909
Medicaid ID # 0038991786
Petitioners agree to endorse this check to the State of Michigan.
c. An amount sufficient to purchase the annuity contract described in
paragraph 12 of the stipulation paid to the life insurance company
from which the annuity will be purchased.
2

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In the absence of a motion for review filed pursuant to RCFC, Appendix B,
the clerk is directed to enter judgment in case 10-809V according to this decision
and the attached stipulation.2 The Clerk’s Office is further instructed to provide
this decision to the Court. Vaccine Rule 28.1(a).
Any questions may be directed to my law clerk, Shannon Proctor, at (202)
357-6360.
IT IS SO ORDERED.
s/ Christian J. Moran
Christian J. Moran
Special Master
2 Pursuant to Vaccine Rule 11(a), the parties can expedite entry of judgment by each
party filing a notice renouncing the right to seek review by a United States Court of Federal
Claims judge.
3

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