Caron v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 15-777V
Filed: January 30, 2018
Reissued for Publication: March 19, 2018 1
* * * * * * * * * * * * * * * * * **
*
HEATHER CARON o/b/o and as next *
friend of A.C., a minor, *
Petitioner, *
Vaccine Act; DTaP, HIB, MMR
*
and Varicella vaccinations;
v. *
CRMO; Onset of Symptoms;
*
SECRETARY OF HEALTH Entitlement.
*
AND HUMAN SERVICES, *
Defendant. *
*
* * * * * * * * * * * * * * * * * **
Verne E. Paradie, Jr., Paradie, Sherman, Walker & Worden, Lewiston, ME, for
Petitioner.
Jennifer L. Reynaud, Trial Attorney, Torts Branch, Civil Division, United States
Department of Justice, Washington, D.C., for Respondent. With her was Alexis B.
Babcock, Assistant Director, Torts Branch, Civil Division, Catherine E. Reeves, Deputy
Director, Torts Branch, Civil Division, C. Salvatore D’Alessio, Acting Director Torts
Branch, and Chad A. Readler, Acting Assistant Attorney General, Civil Division.
OPINION
HORN, J.
On July 23, 2015, Petitioner Heather Caron, parent and next friend of minor, A.C.,
and on behalf of A.C., filed a timely petition for compensation with the National Vaccine
Injury Compensation Program, under the National Childhood Vaccine Injury Act of 1986,
42 U.S.C. §§ 300aa-1–300aa-34 (2012) (Vaccine Act). On September 7, 2017, Special
Master Mindy Michaels Roth of the United States Court of Federal Claims denied
Petitioner’s claim for an award of compensation, finding that Petitioner did not show by a
preponderance of the evidence that she is entitled to compensation under the Vaccine
Act. See Caron v. Sec’y of Health & Human Servs., No. 15-777, 2017 WL 4349189, at
*10 (Spec. Mstr. Fed. Cl. Sept. 7, 2017). On September 26, 2017, Petitioner filed a motion
for review in this court to review the Special Master’s decision denying her claim, pursuant
1 This opinion was issued under seal on January 30, 2018. The parties did not propose
redactions to the January 30, 2018 opinion, and, thus, the court issues the opinion for
public distribution.
to Rule 23 of the Vaccine Rules of the United States Court of Federal Claims (Vaccine
Rules) (2017). This case comes to the court upon that motion.
FINDINGS OF FACT
The following relevant facts are established by the exhibits of records submitted
by Petitioner in this matter and the Special Master’s factual findings from her December
14, 2016 Ruling On Onset and her September 7, 2017 Decision Denying Entitlement. 2
See Caron v. Sec’y of Health & Human Servs., 2017 WL 4349189, at *1-5; see also Caron
v. Sec’y of Health & Human Servs., No. 15-777, 2016 WL 7664309, at *5-9 (Spec. Mstr.
Fed. Cl. Dec. 14, 2016). According to the records before the court, A.C. was born on July
18, 2009, four weeks prematurely. Eleven days after birth, A.C. appeared “alert, well
nourished, well hydrated, [and with] no acute distress,” and by two months old, A.C. was
healthy and well developing.
During his first three years of life, A.C. was seen at the pediatrician’s office over
forty times for a variety of complaints, such as ear infections, insect bites, congestion and
coughing, and for standard well-child visits. According to the records before this court,
prior to the visit on which A.C. received the vaccines at issue in the case before this court
on August 2, 2012, A.C. received routine vaccines on a delayed schedule with no
apparent adverse side-effects.
Among his numerous visits, when he was around ten weeks old, A.C. was admitted
to Maine General Medical Center to “rule out sepsis or pneumonia or meningitis.” When
A.C. was around six months old, he was referred to a pediatric pulmonologist for multiple
respiratory issues. On September 20, 2011, when A.C. was two years old, he was taken
to the emergency room after falling forward and cutting his forehead with his toy train.
Shortly after that visit, on November 8, 2011, Petitioner took A.C. to the emergency room
for a cough and sinus congestion. The medical record notes that because Petitioner and
A.C. were unable to see the primary care physician, she took A.C. to the emergency room
instead. The medical record also states that “[t]he child himself does not have any
complaints. He is quite active as I enter the room.” On July 29, 2012, Petitioner took A.C.
to the pediatrician’s office because A.C. had multiple bug bites. The medical record states
that “[m]om has outlined several because he seems to have some big reactions to them.”
There was “[n]o concern for infection,” however, and A.C. did not have any fever.
2 Initially, Petitioner submitted twelve exhibits, which were hospital and physician records,
from A.C.’s various medical visits, beginning from A.C.’s birth through June 2015.
Petitioner later filed four more exhibits: copies of her 2012 date book and her 2013 date
book, which were hard copies of calendars that Petitioner kept, and two on-line articles
as exhibits to her May 15, 2017 Request For a Ruling On The Record, for a total of sixteen
exhibits before the Special Master and this court.
2
On August 2, 2012, a couple of weeks after his third birthday, A.C. visited the
pediatrician for a well-child visit. He was noted to be a “[w]ell appearing child, appropriate
for age, [with] no acute distress.” He was being home schooled and was behind in his
immunizations. At this August 2, 2012 visit, A.C. received the allegedly causal diphtheria-
tetanus-acellular pertussis (DTaP), haemophilus influenza type B (HIB), measles-
mumps-rubella (MMR) and Varicella vaccinations. 3
On December 4, 2012, approximately four months after A.C. received the August
2, 2012 vaccines at issue in this case, A.C. visited his pediatrician for complaints
regarding his right ear. The medical record notes that his right ear was “closing,” but that
A.C. was acting well and had no fever and made no mention of foot pain. This was A.C.’s
first medical visit after receiving his August 2, 2012 vaccines.
On January 16, 2013, A.C. visited the pediatrician’s office to address foot pain.
The medical record notes:
[Petitioner] concerned about [A.C.’s] R[ight] foot or ankle, seems to be
favoring it, c/o [complaining of] pain; and when sitting/lying down keeps it
flexed up, walking on it abnormally. no known injury[,] no bruising, no
redness, no swelling. since last Thursday, about a week now[,] have tried
ice, no other meds[.]
The pediatrician also noted: a “R[ight] foot in flexed position, toes up; walking mostly on
medial edge of foot . . . no pain with movement, when distracted no tenderness but when
3 All parties and the Special Master agree that the alleged injurious vaccines were
administered on August 2, 2012. Petitioner, defendant, and Special Master Roth each
noted in their filings that A.C. received the inactivated polio virus (IPV) vaccine, along with
the other alleged injurious vaccines, on August 2, 2012. For example, the petition states
that A.C. “received DTap-IPV/Hib, MMR and Varicella vaccinations, . . . on August 2,
2012, . . . .” Defendant’s October 26, 2017 response to Petitioner’s Motion For Review
states that A.C. “received diphtheria-tetanus-acellular pertussis (‘DTap’), inactivated polio
(‘IPV’), haemophilus Type B (‘HIB’), measles-mumps-rubella (‘MMR’), and varicella
vaccinations” on August 2, 2012. Special Master Roth, in her December 14, 2016 Ruling
On Onset and her September 7, 2017 Decision Denying Entitlement, states that A.C.
received the DTaP, IPV/HIB, MMR and Varicella vaccines on August 2, 2012. See Caron
v. Sec’y of Health & Human Servs., 2016 WL 7664309, at *6 (“A.C. received the allegedly
causal DTaP, IPV/HIB, MMR and Varicella vaccines at that visit.”); see also Caron v.
Sec’y of Health & Human Servs., 2017 WL 4349189, at *2 (“A.C. received the allegedly
causal DTaP, IPV/HIB, MMR and Varicella vaccinations at this visit.”). Upon review of
A.C.’s medical records, however, it appears that A.C. did not receive the IPV vaccine on
August 2, 2012. The immunization record for A.C. from MidCoast Pediatrics and the
medical chart dated August 2, 2012 that was electronically signed by Dr. Emily
Wesolowski at MidCoast Pediatrics, which were filed by Petitioner as part of A.C.’s
medical records before the Special Master and this court, however, indicate that A.C.
received only the DTaP, the HIB, the MMR, and the Varicella vaccines on August 2, 2012.
3
asked points to top of foot that hurts. no edema, no erythema, no ecchymosis[.]” A.C.’s
foot was wrapped in an ace bandage and Petitioner was told to follow up as needed.
On January 19, 2013, Petitioner took A.C. to Mid Coast Hospital with “20 hours of
fever up to 105.” The medical record states that A.C. had been complaining of some head
pain and nausea and that A.C. had experienced decreased appetite and activity, but also
states that during his physical exam, A.C. was “alert, happy, smiling, interactive and
playful, consolable, well hydrated, . . . appears pain free.” Additionally, an examination of
his joints and back were “normal”; A.C. “[m]ove[d] all extremities equally”; there were “no
focal motor deficits” and A.C. had a “nml [normal] gait.”
As reported in the medical records, A.C.’s joint pain increased and he was seen
various times regarding this pain throughout March 2013. For example, the medical
record indicates that A.C. had “neck pain when turning head fast . . . [and] not wanting to
move [his] neck,” and by March 26, 2013, A.C. “[o]ften times . . . complain[ed] of pain so
much that he just [sat] on the couch and then put[] himself to bed.”
On April 4, 2013, A.C. was admitted to the Barbara Bush Children’s Hospital at the
Maine Medical Center with symptoms of “headache, polyarthralgia, fever and weight
loss.” According to the medical record, A.C.’s “symptoms had been present for several
months but had worsened in the past few week [sic] to the point where he could not
stand.” The medical record further notes:
The patient is a 3 y.o. male without a significant past medical history who
presents with fever and joint pain. Mom reports that in January, he had right
foot with limping. Seen by PCP [primary care physician] and xray looked
fine. Treated with an ace bandage. Symptoms resolved within 1 week. Then
in march, he complained of BL foot pain and left knee pain. Seen by ortho.
More x rays no fracture. PCP referred to rheumatology. Last 5 week [sic],
his pain has progressively worsened and he was staying up at night crying.
Now, he is complaining of R butt or hip pain, R knee, feet, hand pain. Not
wanting to pick up things with hands. No swelling or redness of joints. They
feel warm to mom. Fever for the past 2 weeks, 99-101 almost every day.
Worse at night. Past 3 days, his fever has been getting higher up to 103.
Last night, mom took him to Midcoast ED [emergency department] for fever
and neck pain. Not extending head to look up. Decreased ROM [range of
motion] turning head. Not wanting to bear weight unless given pain
medications.
During this hospital stay, A.C. underwent extensive testing, including a bone scan, a
magnetic resonance imaging (MRI) of his neck, and bone biopsies from his mandible and
tibia. On April 13, 2013, A.C. was discharged with an initial diagnosis of polyostotic fibrous
dysplasia and hypophosphatemia. 4
4 Fibrous dysplasia is defined as “a disease of bone marked by thinning of the cortex and
replacement of bone marrow by gritty fibrous tissue containing bony spicules, producing
4
Other medical reports taken during A.C.’s April 2013 hospital stay reflect a similar
history of foot pain beginning around January 2013. The pediatric oncologist noted, “[i]n
January of 2013 c/o [complaining of] intermittent pain in foot. Pain self resolved. Pain
reoccurred And seen by orthopedics.” The resident pediatrics specialist noted that “[m]om
reports that in January, he had right foot with limping. . . . Symptoms resolved within 1
week.” The rheumatologist noted that, “[A.C.] is known to me. I saw him for the 1st time
on 4/2 with 2-3 month h/o [history of] arthralgia localized to knees, left foot, and neck.”
The pediatric infectious disease consult noted that “[t]he history was obtained from
mother. [A.C.] is a 3 y.o. male who presented yesterday with 3-4 months of joint pain and
intermittent fevers. [A.C.] was in his typical state of health until mid January when he
began to have pain of his right foot and ankle.”
On April 29, 2013, A.C. had a follow-up visit with the rheumatologist, who noted
that A.C.’s illness can “best be described as chronic recurrent multifocal osteomyelitis,”
although there was an initial belief that A.C. may have had fibrous dysplasia. The
rheumatologist also noted that A.C.’s hypophosphatemia had since been corrected with
medication. On June 10, 2013, the rheumatologist noted that the medical consensus
regarding A.C.’s symptoms is a diagnosis of Chronic Recurrent Multifocal Osteomyelitis
(CRMO). 5 During the ensuing months, A.C. was seen by his rheumatologist and received
immunosuppressive therapy to treat his CRMO.
According to the medical records before the court from Rheumatology Associates,
P.A., the rheumatology practice that A.C. was visiting in 2015, as of June 1, 2015, A.C.’s
CRMO was in remission. At a June 1, 2015 visit, the rheumatologist noted, however, that
A.C. continued to have stiffness in the morning and left knee pain. The rheumatologist
also noted that x-rays of the left knee were “normal” but A.C.’s MRI did show a bony
abnormality.
On July 23, 2015, Petitioner filed a timely petition on behalf of A.C. for
compensation with the National Vaccine Injury Compensation Program, pursuant to the
Vaccine Act. Petitioner alleged that:
[A.C.] received DTap-IPV/Hib, MMR and Varicella vaccinations, which are
all ‘Table’ vaccinations, on August 2, 2012, and who thereafter suffered from
pain, disability, and gradually increasing deformity.” Dorland’s Illustrated Medical
Dictionary 581 (32nd ed. 2012). Polyostotic fibrous dysplasia is a “later stage of fibrous
dysplasia of bone in which several or many bones are involved.” Id. Hypophosphatemia
is defined as “an abnormally decreased amount of phosphates in the blood,” and
“manifestations include hemolysis, lassitude, weakness, and convulsions.” Id. at 904.
5 Osteomyelitis is defined as “inflammation of bone caused by infection, usually by a
pyogenic organism, although any infectious agent may be involved. It may remain
localized or may spread through the bone to involve the marrow, cortex, cancellous
tissue, and periosteum.” Dorland’s Illustrated Medical Dictionary 1347 (32nd ed. 2012).
Multifocal means “arising from or pertaining to many foci.” Id. at 1187.
5
Chronic Multifocal Osteomyelitis, as well as chronic episodes of acute otitis
media, fever, coughing, leg pain, neck pain, and joint pain, and related
symptoms and associated symptoms and deficits, which were caused in
fact by the above stated vaccination.
Petitioner filed an affidavit from Petitioner Heather Caron, A.C.’s mother, with the petition
and, aside from the civil cover sheet, did not submit any other documentation with the
petition.
In her affidavit, Petitioner stated that “[s]oon after the vaccination, A.C. began to
experience pain and related symptoms in his foot and ankle, but my husband and I did
not immediately seek medical attention because the symptoms did not appear to be
significant.” She stated that “[h]owever, by January of 2013, A.C.’s symptoms and
complaints of pain in his fight [sic] foot and ankle had become far worse.” She then stated
that “[h]is symptoms persisted into February without an obvious cause, and A.C. began
limping.” According to Petitioner’s affidavit, by April of 2013, A.C. was having “difficulty
sleeping and was running a consistent low grade fever.” Petitioner then stated that A.C.
“was hospitalized for further evaluation at Maine Medical Center in Portland, Maine on
April 4, 2013” and was “discharged on April 13, 2013.” In June of 2013, according to
Petitioner’s affidavit, “bone biopsy results indicated chronic recurrent multifocal
osteomyelitis.” Petitioner then stated that “A.C. has undergone multiple evaluations and
treatment for his multifocal osteomyelitis and related symptoms and continues to suffer
from the same.”
On July 24, 2015, Petitioner’s case was assigned to Special Master Lisa Hamilton-
Fieldman. 6 Also on July 24, 2015, Special Master Hamilton-Fieldman issued an order
requiring Petitioner “to file a statement of completion when the process of filing medical
records is deemed complete” and particularly requested that Petitioner file “pre-
vaccination records starting from three years prior to vaccination.” The Special Master
“directed [Petitioner] to 42 U.S.C. § 300aa-11(c)(2) which lists what types of records
should be filed . . . . [to] include pre-injury, physician, and clinic records.” 7
6 This case was originally assigned to Special Master Lisa Hamilton-Fieldman and
transferred to Special Master Mindy Michaels Roth on January 14, 2016.
7 Pursuant to 42 U.S.C. § 300aa-11(c), entitled “Petition Content”, a “petition for
compensation under the Program for a vaccine-related injury or death shall contain . . .
an affidavit, and supporting documentation,” and shall also include:
maternal prenatal and delivery records, newborn hospital records (including
all physicians’ and nurses’ notes and test results), vaccination records
associated with the vaccine allegedly causing the injury, pre- and post-injury
physician or clinic records (included all relevant growth charts and test
results), all post-injury inpatient and outpatient records (including all
provider notes, test results, and medication records)[.]
6
On July 25, 2015, Petitioner filed a Notice Of Filing Of CD’s Containing Medical
Records which listed the twelve exhibits of medical records she filed with the clerk of
Court. Each exhibit was a compilation of the contemporaneous records from a particular
physician’s office or hospital that A.C. had visited during approximately the first six years
of his life. In total, Petitioner submitted 482 pages of medical records. Thereafter,
Petitioner certified to Special Master Hamilton-Fieldman, via a statement of completion
that “she believes she has provided the entire medical records associated with
Petitioner’s petition.” In an October 20, 2015 order, Special Master Hamilton-Fieldman
stated that during an October 19, 2015 status conference, “the undersigned concurred
with Respondent’s argument . . . that there is insufficient evidence in the record to support
Petitioner’s allegation that onset occurred in the fall of 2012.” Special Master Hamilton-
Fieldman stated that, “[c]ontrary to the assertions in Petitioner’s affidavit, multiple
treatment providers have documented self-reported onset in January of 2013.” Special
Master Hamilton-Fieldman then ordered that “Petitioner shall file any additional
documentation of the earlier alleged onset” and “an additional affidavit . . . explaining why
the medical records unanimously document onset in January 2013.”
On November 16, 2015, Petitioner filed a supplemental affidavit in support of her
allegation that the onset of A.C.’s symptoms began earlier than January 2013, as
documented by the contemporaneous medical records. Petitioner repeated from her initial
affidavit that “[s]oon after the vaccination, A.C. began to experience pain and related
symptoms in his foot and ankle, but my husband and I did not immediately seek medical
attention because the symptoms did not appear to be significant.” Petitioner, however,
newly alleged that at least on five separate occasions before January 2013, A.C.
presented with symptoms, such as, being “very quiet, [and] distant,” having “pain in his
feet” and a “slightly abnormal gait,” being “extremely fatigued,” and “running a consistent
low-grade fever.” Petitioner also alleged in her supplemental affidavit that on or about
August 19, 2012, A.C. and Petitioner visited the home of Patricia Bailey, and “Ms. Bailey
reported to me that . . . she found A.C. to be very quiet, distant and not interacting with
the other children, which was not his normal behavior.” Petitioner does not explain in her
supplemental affidavit how she knew Ms. Bailey. Petitioner, however, later testified at the
July 11, 2016 fact hearing before Special Master Roth that Ms. Bailey was a friend from
her church. Petitioner then alleged in her supplemental affidavit that in September 2012,
A.C. spent the weekend with Jennifer Rowe and Jeremy Gordon, when his parents were
away. Petitioner also does not explain in her supplemental affidavit how she knew
Jennifer Rowe and Jeremy Gordon. Petitioner later testified at the July 11, 2016 fact
hearing before Special Master Roth they are her aunt and uncle. While A.C. stayed with
Jennifer Rowe and Jeremy Gordon, according to Petitioner, A.C. complained of foot pain
to them.
42 U.S.C. §§300aa-11(c)(1), (2). A petition also should also include “an identification of
any records of the type described in paragraph (1) or (2) which are unavailable to the
petitioner and the reasons for their unavailability.” 42 U.S.C. § 300aa-11(c)(3).
7
Petitioner further alleged in her supplemental affidavit that in October 2012,
Petitioner and A.C. visited the home of Dixy Love O’Neill. Petitioner did not state in her
supplemental affidavit how she knew Ms. O’Neill. Petitioner later testified at the July 11,
2016 fact hearing before Special Master Roth that Ms. O’Neill was a friend from church.
According to Petitioner, Ms. O’Neill informed Petitioner that “she recalled A.C.
complaining about pain in his feet on that occasion and asking to be carried down to see
her horses.”
In addition, Petitioner alleged in her supplemental affidavit that in November 2012,
Irvin and Theresa Joseph visited Petitioner’s home. According to Petitioner, Irvin Joseph
informed Petitioner that while he was at Petitioner’s home, he noticed that “A.C. was
walking with a slightly abnormal gait and heard him complain of pain in his feet.” According
to Petitioner, Theresa Joseph also informed Petitioner that “A.C. and she were sitting on
the stairs at the family home, A.C. told her about the ‘boo boos’ in his feet.” Petitioner
then alleged that in late December 2012, Petitioner and A.C. visited the Josephs’ home,
during which time “A.C. was running a consistent low-grade fever.” Petitioner did not
explain in her supplemental affidavit how she knew the Josephs, but later testified at the
July 11, 2016 fact hearing before Special Master Roth that the Josephs were her
husband’s mother and stepfather, A.C.’s grandparents.
Petitioner also alleged in her supplemental affidavit that “I maintained a date book
back in 2012, where I recorded all important dates and events” and that “I can recall all
of these dates because I recorded them in my date book.” 8 Petitioner filed with Special
Master Hamilton-Fieldman a black-and-white copy of the date book she referenced in her
supplemental affidavit, which Petitioner labeled as exhibit thirteen. Based on the record
before the court, Petitioner’s date book consists of ten pages from a 2012 calendar. Each
page corresponds to a particular month, spanning from March to December 2012. The
date book does not contain pages for the months of January and February 2012. The
date book also displays handwritten notes under particular days, such as “Mom Dentist”
under July 9, 2012, and “Pats ap. @ 5:40” under July 2, 2012. For example, the date book
reflects the following notes for the respective dates that Petitioner discussed in her
supplemental affidavit as the times when A.C. allegedly presented with vaccine related
symptoms during the fall of 2012:
• for August 19, 2012, the date book entry states, “Dress Up Day/Party” and “Ant
Pain in Foot;”
8 Although Petitioner states that she “can recall of these dates because I recorded them
in my date book,” it appears that Petitioner did not actually write in any numerical dates
in the date book, which is a pre-printed month at a time form calendar that has individual
boxes for each day of the month. The numerical dates pre-printed in the upper left hand
corner of each of the individual boxes and Petitioner’s brief, hand written notes are visible
on the calendar in the individual boxes.
8
• for September 22, 2012, the date book entry states, “½ h,” “Pats Fishin [sic] Trip,”
“Last week cleaning,” and “8 miles;” the date book does not have anything noted
for September 23, 2012;
• for October 15, 2012, the date book entry states, “1 return,” “Dixy’s House for
Coffee.” “Pain Ant Foot,” and “1 ½ hrs;”
• for November 17, 2012, the date book entry states, “Pain in Ant Feet,” “Pats Mom,”
“1 ½ hrs;” and for November 18, “Pats Mom;”
• for the period of December 26 through 29 of 2012, the date book entry displays a
line running through the entries for December 26, 27, 28, and 29, and states, “Foot
Pain,” and “Pats Mom.”
Notably, when Petitioner was asked by Petitioner’s counsel at the July 11, 2016
fact hearing before Special Master Roth whether she contemporaneously made the
handwritten notes in her date book regarding A.C.’s alleged complaints of foot pain,
Petitioner stated that she did not. The following colloquy occurred between Petitioner’s
counsel and Petitioner at the July 11, 2016 fact hearing regarding Petitioner’s 2012 date
book:
Q. Did you, in fact, keep a date book back in August of 2012?
A. Yes.
Q. And is that a place you would record events that would occur in your life?
A. Yeah. Just about everything I don't want to forget.
Q. Okay. And you would -- and you have a copy of that that you’ve provided
to us and we’ve submitted to the Court?
A. Yes.
Q. And just so the Court is clear, I’m showing you, this is the original. Is that
right?
A. Yes.
Q. And have you at some point in time gone back and written in dates when
you remember A.C. complaining about foot pain?
A. Yes.
Q. And when did you -- when did you go back and write those in, or actually,
let me ask it this way: Did you write his complaints in contemporaneous to
9
his complaints? In other words, at the same time, or did you go back later
and put those in?
A. I went back later and put those in.
Q. And do you remember when it was that you went back and put those in?
A. It was when he first started seeing Dr. Holly Brown, and so that was in
2014, I believe.
As Petitioner testified at the July 11, 2016 hearing, Dr. Holly Brown is “a licensed
acupuncturist and oriental medical doctor.” Petitioner explained that Dr. Brown expressed
concern that the vaccinations may have caused A.C.’s issues and told Petitioner to see
how far back she could remember A.C. having any complaint at all.
Petitioner’s counsel also asked Petitioner the following question regarding the
2012 date book at the July 11, 2016 hearing:
Q. Okay. And, so, there are certain dates where you wrote down on exact
dates days that he complained. How is it that you remember two years later
the specific dates that he had complained on?
A. Because I could remember those events and what was going on that
day.
In addition to her supplemental affidavit, Petitioner filed affidavits from four of the
six individuals 9 she had previously alleged witnessed A.C.’s fall 2012 onset of symptoms
in her supplemental affidavit: Jennifer Rowe and Jeremy Gordon, who each stated in their
respective affidavits that they had witnessed A.C. experience foot pain in September
2012, and Irvin and Theresa Joseph, who each stated in their respective affidavits that
they had witnessed A.C. experience foot pain in November 2012. Based on the affidavits,
all four affiants did not independently recall the dates of their observations of A.C., but
instead, based the dates they included in their affidavits on the dates Petitioner shared
with each of them from her retroactively edited date book. The affidavits for Theresa and
Irvin Joseph each state in identical wording that “I can remember the dates, because
Heather Caron apparently maintained a date book with dates that she and I would have
seen each other and recently shared that date book with me.” The affidavits for Jennifer
Rowe and Jeremy Gordon also respectively state in identical wording that “I can
remember the date, because Heather Caron apparently maintained a date book with
9 Based on the record before the court, Petitioner did not provide an affidavit for Ms.
O’Neill. Petitioner also did not provide an affidavit for Patricia Bailey despite Petitioner’s
statement in her Motion For Review that she “provided affidavits from Ms. Bailey and
others regarding their observations of A.C.” and her statement in her May 15, 2017
Request For Ruling On The Record before Special Master Roth that “[t]he record already
contains affidavits from Ms. Bailey and others regarding their observations of A.C.”
10
dates that this overnight would have occurred and recently shared that date book with
me.”
After Petitioner filed her November 16, 2015 supplemental affidavit and the four
affidavits in support of an alleged fall of 2012 onset, Special Master Hamilton-Fieldman
continued to have “concerns regarding the reliability of the evidence in support of the
earlier alleged [2012] onset” and thus, on December 28, 2015, ordered Petitioner to file a
brief “regarding the alleged timing of onset” and the government to file a responsive brief.
In particular, Special Master Hamilton-Fieldman noted in her order, dated December 28,
2015, that Petitioner recently filed “affidavits and datebook . . . in support of her allegation
that the onset of A.C.’s injury occurred in the fall of 2012.” Special Master Hamilton-
Fieldman then noted that “to the extent that these records contemporaneously document
an early onset, they contradict previously submitted medical records documenting self-
reported onset in January of 2013.”
The parties subsequently submitted briefs to Special Master Hamilton-Fieldman
regarding the alleged timing of the onset of A.C.’s symptoms. In her brief, Petitioner
admitted that “the medical records indicate onset of symptoms as January of 2013,” yet
she argued that the multiple affidavits she had filed in support of her allegation of a fall
2012 onset “are overwhelmingly more persuasive than the medical records regarding the
onset of A.C.’s symptoms.” Petitioner stated that “should the Court not be persuaded by
the affidavits in this matter, Petitioner requests an evidentiary hearing for the Court to
resolve the apparent tension between the medical records and the later recorded
recollections.”
In its response brief, the government argued that Petitioner “has not shown by
preponderant evidence that A.C.’s symptoms began in the fall of 2012.” The government
first argued that it “strains reason” to conclude that A.C.’s symptoms began in the fall of
2012 because the Special Master “would be required to find that either petitioner
consistently misreported the onset of A.C.’s symptoms or that all of the medical providers
affiliated with various institutions inaccurately recorded the same incorrect onset of
January 2013.” The government then argued that because Theresa Joseph, Irvin Joseph,
Jennifer Rowe, and Jeremy Gordon, the four relatives of Petitioner and A.C. who
submitted affidavits in this case, “have no independent recollection as to when they
observed [A.C.’s] symptoms, their affidavits can be of little if any persuasive value as to
onset, particularly given . . . petitioner’s many and consistent contemporaneously
recorded statements to medical providers that A.C.’s symptoms began in January 2013.”
The government also argued that the Special Master should not hold a fact hearing
regarding the onset of A.C.’s symptoms, as requested by Petitioner in her brief regarding
onset, because “[t]here is nothing in the record to suggest that at any time petitioner failed
to report or inaccurately reported the onset of her son’s symptoms.”
Before Special Master Hamilton-Fieldman ruled on Petitioner’s request for a fact
hearing on onset or established an onset date, Petitioner’s case was reassigned to
Special Master Mindy Michaels Roth on January 14, 2016. Special Master Roth
subsequently ordered that Petitioner’s request for an onset hearing would be granted to
11
discuss the probative value of the affidavits and date book. Before the onset hearing in
front of Special Master Roth, Petitioner submitted her second, supplemental affidavit on
June 21, 2016. This affidavit was identical to her previous affidavit submitted on
November 16, 2015, with the exception of the final paragraph, which states that “[t]he
reason that we did not seek medical evaluation for several months was due to a
disagreement between me and my husband as to whether evaluation was necessary.”
On July 11, 2016, the Special Master held a video conference fact hearing to
determine the timing of onset. For the Petitioner, only Ms. Caron, the Petitioner, testified.
On direct examination, Petitioner stated that she did not notice anything out of the ordinary
immediately following the administration of A.C.’s alleged injurious vaccinations on
August 2, 2012. “In the coming weeks or months” of the administration of the alleged
injurious vaccines, Petitioner testified that A.C. “was having an abnormal gait . . . limping
a little, complaining about a boo-boo on his foot. Nothing that was really too alarming.”
When asked by her counsel when A.C. first “started complaining about any foot-related
pain, and being tired” Petitioner stated in August. When asked by her counsel whether
she had “some significant concerns about [A.C.’s] foot complaints in the months following
the vaccinations,” Petitioner responded “[n]ot initially.”
As previously discussed, Petitioner testified at the July 11, 2016 fact hearing that
she kept a date book in 2012 and recorded “[j]ust about everything I don’t want to forget”
in her date book. She also testified, however, that she did not contemporaneously
document A.C.’s complaints but instead went back in 2014 and made notes in the date
book of when A.C. complained about foot pain at the suggestion of Dr. Holly Brown.
Petitioner also discussed at the hearing the five occasions between August and
December 2012 that A.C. presented with, what she alleged, were vaccine related
symptoms. Petitioner then testified that she and her husband did not immediately seek
medical attention for A.C.’s foot pain because her husband was “very insistent” that A.C.’s
symptoms were “growing pains” and that they “weren’t going to take him to the doctor,”
so Petitioner “had to listen” to her husband.
Petitioner eventually took A.C. to the doctor’s office on December 4, 2012 for an
ear ache. The medical records do not indicate that Petitioner mentioned A.C.’s foot pain
at that visit. Petitioner, however, testified at the July 11, 2016 hearing before Special
Master Roth that she did mention A.C.’s foot pain and that the “doctor agreed that they
thought it was just growing pains and if it was something . . . just to bring him back . . . .”
When Petitioner discussed A.C.’s next medical visit in January 2013, she initially testified
at the July 11, 2016 hearing that she could not remember whether she had mentioned to
the doctor that A.C. had been having foot pain throughout the fall. She later testified at
that same hearing that she was “pretty sure” that she had discussed it “but it wasn’t
documented.”
At the hearing, after the direct-examination of Petitioner concluded, the
government did not cross examine Petitioner. Special Master Roth, however, posed
several questions to Petitioner, including asking Petitioner about A.C.’s medical visits
beginning in January 2013:
12
Q. Let me just understand correctly that you said you believe that A.C.'s
symptoms started in August, correct? Is that what you said?
A. Yeah, I know they started in August.
Q. Okay. What symptoms were those in August?
A. It was just mild foot pain and fatigue.
Q. And this fatigue, was that unusual for him?
A. Yes.
Q. And how long did it go on?
A. It continued to progress on and off, and the fatigue would correspond
with the foot pain. And then like in January was when things started to get
severe.
Q. Okay. So, your counsel took you through various doctors' visits. I want
to take you back to January. I believe that you took A.C. to Mid Coast
Hospital on January 9th, 2013, with 20 hours of high fever, and they did a
joint exam and neuro exam on him which was normal. Did you mention to
the doctors that he had been having this foot pain and this fatigue?
A. Yes.
Q. And they didn’t document it?
A. I guess not.
Q. Okay. And in February, on the 8th, you took him to the pediatrician with
a cold and a fever, five days of cough and fever of 103. Do you recall that?
A. Yes.
Q. Did you mention to the doctors that he had this foot pain that was
continuing intermittently over the last several months?
A. Yes.
Q. You did?
A. I mentioned that he was complaining about his foot and that my husband
thought it was just growing pains.
13
Q. And what did the doctor say?
A. They told me -- you know, it probably is, it doesn’t seem like something
we should be concerned about. They palpated his foot. And, you know, just
told me to return if things get worse.
Q. Okay. And on March 1st, you took him to the pediatrician with stomach
pain for over an hour, crying, but it had resolved by the time you got there.
Do you recall that?
A. Yeah.
Q. Did you mention to the doctor that he was still having this intermittent
foot pain at that point?
A. I asked her if it could be connected, if they were all one thing, and she
said probably not, he was probably just having some gas pain and, you
know, wasn’t concerned at all, just poo-poo’d the whole foot thing.
On December 14, 2016, Special Master Roth issued a Ruling On Onset, finding
“that A.C.’s symptoms of CRMO began in January of 2013.” See Caron v. Sec’y of Health
& Human Servs., 2016 WL 7664309, at *15. The Special Master found that “the
contemporaneous medical records and histories provided by petitioner to her child’s
medical providers at the time of the events more accurately reflect the onset of A.C.’s
CRMO” than Petitioner’s testimony, affidavits and date book. Id. at *2. Specifically,
Special Master Roth found that the medical records “consistently reflect that A.C.’s
symptoms started in January 2013—not before.” Id. at *13. The Special Master
highlighted that Petitioner showed no hesitation in seeking medical intervention for A.C.
when he was ill, hurt or even had large bug bites. See id. at *15. She also noted that the
medical records documented that A.C. began having foot pain in January of 2013 and
Petitioner took him to the pediatrician with that complaint. See id. The Special Master
reiterated that it “strains reason” to conclude that Petitioner would have failed to
accurately report to physicians the onset of A.C.’s symptoms. Id. She also noted that it
was equally unlikely that all of the various doctors who had seen A.C., who are
presumably trained in taking medical histories, would have failed to document or would
inaccurately have documented the mother’s complaints of the onset of his condition. See
id. Special Master Roth also stated that:
Petitioner is ordered to provide a copy of this fact ruling to each of her expert
witnesses. Petitioner's expert(s) must rely on the facts as I have found them
in this Ruling. In crafting their expert report, no expert may rely on Ms.
Caron's testimony, affidavit, or the affidavits submitted by the various
individuals who relied solely on Ms. Caron's date book for their recollections
of events. . . . By no later than Tuesday, March 14, 2017, petitioner must
file either an expert report that is based on the facts as I have found them
herein, or a status report indicating how she intends to proceed. If petitioner
is unable to secure reports from her expert(s) based on the timing of onset
14
as I have found it, she must file either a motion to dismiss, a joint stipulation
for dismissal, or a motion for a ruling on the record, all of which will result in
the dismissal of her claim.
Id.
Thereafter, Petitioner filed a status report with Special Master Roth requesting a
deadline for filing a request for a ruling on the record so as to seek “judicial review” of the
“Court’s conclusion that [A.C.’s] symptoms started much later than what his mother
testified to . . . .” Petitioner filed her Request For Ruling On The Record on May 15, 2017.
Petitioner stated that Special Master Roth should “reconsider the earlier decision
regarding onset of A.C.’s symptoms and hold a hearing.” Petitioner argued “that the
testimony of A.C.’s parents and the affidavits submitted by independent witnesses
regarding the onset of A.C.’s symptoms is sufficient to overcome the rebuttable
presumption that the information contained in the medical records is accurate.” Further,
Petitioner challenged Special Master Roth’s previous order in her December 14, 2016
Ruling On Onset that any expert witnesses engaged by Petitioner must rely on the Special
Master’s finding that the onset of A.C.’s symptoms of CRMO began in January 2013. Id.
Petitioner argued to Special Master Roth “that had she been allowed to seek an expert
opinion regarding the cause of the osteomyelitis occurring just weeks after the vaccination
. . . she would have been fully able to meet her burden under Althen [Althen v. Sec’y of
Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005)].” Petitioner claimed that she
“can establish at hearing that [A.C.’s] vaccinations caused his osteomyelitis under the
Althen standard.” She attached two exhibits to her Request For Ruling On The Record as
support: an on-line article providing a general overview of vaccinations, and a five-page
article reporting two cases of osteomyelitis as a complication of the Varicella virus.
On September 7, 2017, Special Master Roth issued her Decision Denying
Entitlement, finding that Petitioner had failed to carry her burden of proving causation and
the Special Master dismissed the Petition. See Caron v. Sec’y of Health & Human Servs.,
2017 WL 4349189, at *10. Special Master Roth explained that Petitioner had “failed to
provide any expert or medical evidence to support her claim that the vaccinations A.C.
received in August 2012 caused his injuries.” Id. The Special Master also noted that “none
of A.C.’s treating physicians related the CRMO to any of the vaccinations he received.”
Id. Special Master Roth concluded that Petitioner “cannot sustain her burden of proof on
any of the Althen prongs.” Id.
In that same decision, Special Master Roth also denied Petitioner’s request for
reconsideration of her December 14, 2016 Ruling On Onset regarding the Special
Master’s determination of a January 2013 onset date and Petitioner’s demand for a
hearing. The Special Master explained that it was procedurally improper because,
pursuant to the Vaccine Rules, a party may only seek reconsideration of a special
master’s “decision on whether the petitioner is entitled to ‘an award of compensation’ and
‘if so, the amount thereof.’” Id. at *8 (quoting Vaccine Rule 10(a) (2017)). According to
Special Master Roth, the Special Master’s December 14, 2016 Ruling On Onset “was not
a decision but rather, it was a ruling following a fact hearing which resolved” evidentiary
discrepancies and was “thus not a ‘decision’ that was subject to a motion for
15
reconsideration under the Vaccine Rules.” Id. (emphasis in original). Special Master Roth
also stated that Petitioner’s request for reconsideration was “without basis” because
Petitioner “has not identified anything that would change the outcome of the Ruling On
Onset.” Id. Thus, according to Special Master Roth, “petitioner’s discontent with the
Ruling On Onset would not satisfy the standard [for a motion for reconsideration] under
Vaccine Rule 10(e)(3).” Id. at *9. Petitioner then filed her Motion For Review Of Special
Master’s Decision And Memorandum In Support Of The Same in this court on September
26, 2017.
DISCUSSION
Before this court, Petitioner frames the Motion For Review as challenging the
Special Master’s December 14, 2016 Ruling On Onset, in which Special Master Roth
found a January 2013 onset of symptoms, and also Special Master Roth’s September 7,
2017 Decision Denying Entitlement. In her Motion For Review, Petitioner “submits that
the testimony of A.C.’s parents and the affidavits submitted by independent witnesses
regarding the onset of A.C.’s symptoms are sufficient to overcome the rebuttable
presumption that the information contained in the medical records is accurate.” Although
Petitioner essentially admits in her Motion For Review before this court that she has not
presented evidence of causation to meet her burden of proof for compensation under the
Vaccine Program, Petitioner argues that the Special Master’s December 14, 2016 Ruling
On Onset establishing a January 2013 onset prevented her from presenting such
evidence. Petitioner argues that she “has been denied the opportunity to even present
evidence to meet her burden by the Special Master’s decision regarding onset of
symptoms.” Petitioner asserts that “[b]ecause of the Special Master’s ruling [of a January
2013 onset], Petitioner was unable to secure an expert opinion regarding the relationship
between the administration of the vaccinations and an onset of symptoms that long after
the vaccinations.” Petitioner argues that “[h]ad the Special Master allowed Petitioner to
show an expert credible evidence that A.C. was experiencing symptoms soon after the
vaccination, she could have likely established at a hearing that the vaccinations caused
his osteomyelitis under the Althen standard.” Thus, according to Petitioner, “the Special
Master’s decision effectively precluded Petitioner from establishing causation, because
Petitioner was unable to tell an expert that A.C. was experiencing symptoms soon after
the vaccination.” Petitioner “submits that she . . . should be allowed to pursue obtaining
an expert opinion consistent with this evidence and have an evidentiary hearing to
establish whether she is entitled to compensation.”
The government responds that “Petitioner has not shown that the special master’s
determination was arbitrary, capricious, an abuse of discretion, or not in accordance with
law,” and thus, “the special master’s Decision must be affirmed.” According to the
government, in her decision, the Special Master “carefully articulated and properly applied
the controlling law . . . [and] thoroughly reviewed and evaluated the evidence as a whole.”
In particular, the government argues that “the medical records . . . reveal petitioner to be
a very observant parent, who did not hesitate to take her son to see the doctor for more
minor health issues.” The government also notes that “the medical records from both
before and after vaccination show petitioner to be a very reliable historian” and that
16
“petitioner consistently told each of her son’s doctors that his symptoms began in January
2013.” The government explains that “for the special master to have concluded that A.C.’s
symptoms began earlier [than January 2013], she would be required to find that either
petitioner consistently misreported the onset of AC’s symptoms or that all of the medical
providers affiliated with various institutions inaccurately recorded the same incorrect
onset of January 2013.” As it stated earlier in the proceedings, according to the
government, such a conclusion “strains reason.”
When reviewing a Special Master’s decision, the assigned Judge of the United
States Court of Federal Claims shall:
(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 conclusions of law of the special master
found to be arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law and issue its own findings of fact and conclusions of
law, or
(C) remand the petition to the special master for further action in accordance
with the court’s direction.
42 U.S.C. § 300aa-12(e)(2). The legislative history of the Vaccine Act states: “The
conferees have provided for a limited standard for appeal from the [special] master's
decision and do not intend that this procedure be used frequently, but rather in those
cases in which a truly arbitrary decision has been made." H.R. Rep. No. 101-386, at 517
(1989) (Conf. Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.
In order to recover under the Vaccine Act, Petitioners must prove that the vaccine
caused the purported injury. See W.C. v. Sec’y of Health & Human Servs., 704 F.3d
1352, 1355-56 (Fed. Cir. 2013) (“The Vaccine Act created the National Vaccine Injury
Compensation Program, which allows certain petitioners to be compensated upon
showing, among other things, that a person ‘sustained, or had significantly aggravated’ a
vaccine-related ‘illness, disability, injury, or condition.’” (quoting 42 U.S.C. § 300aa–
11(c)(1)(C))); Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343, 1350 (Fed.
Cir. 2011) (“A petitioner seeking compensation under the Vaccine Act must prove by a
preponderance of the evidence that the injury or death at issue was caused by a
vaccine.”); see also Shapiro v. Sec’y of Health & Human Servs., 105 Fed. Cl. 353, 358
(2012), aff’d, 503 F. App’x 952 (Fed. Cir. 2013); Jarvis v. Sec’y of Health & Human Servs.,
99 Fed. Cl. 47, 54 (2011).
Regarding the standard of review, articulated in Markovich v. Secretary of Health
and Human Services, the United States Court of Appeals for the Federal Circuit wrote,
“[u]nder the Vaccine Act, the Court of Federal Claims reviews the Chief Special Master's
decision to determine if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with the law.’ 42 U.S.C. § 300aa-12(e)(2)(B).” Markovich v. Sec’y of Health
& Human Servs., 477 F.3d 1353, 1355-56 (Fed. Cir.), cert. denied, 552 U.S. 816 (2007);
see also Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363,
17
1366 (Fed. Cir.) (The United States Court of Appeals for the Federal Circuit stated that
“we ‘perform[ ] the same task as the Court of Federal Claims and determine[ ] anew
whether the special master's findings were arbitrary or capricious.’” (quoting Lampe v.
Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000))) (brackets in
original), reh’g and reh’g en banc denied (Fed. Cir. 2013); W.C. v. Sec’y of Health &
Human Servs., 704 F.3d at 1355; Hibbard v. Sec’y of Health & Human Servs., 698 F.3d
1355, 1363 (Fed. Cir. 2012); Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343,
1347 (Fed. Cir.) (“Under the Vaccine Act, we review a decision of the special master
under the same standard as the Court of Federal Claims and determine if it is ‘arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law.’” (quoting 42
U.S.C. § 300aa-12(e)(2)(B))), reh’g and reh’g en banc denied (Fed. Cir. 2008); de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. Cir.), reh’g and reh’g en
banc denied (Fed. Cir. 2008); Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274,
1277 (Fed. Cir. 2005); Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. 43, 47
(2013); Taylor v. Sec’y of Health & Human Servs., 108 Fed. Cl. 807, 817 (2013). The
arbitrary and capricious standard is “well understood to be the most deferential possible.”
Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 (Fed. Cir. 1992).
Therefore, this court may set aside a Special Master’s decision only if the court
determines that the “findings of fact or conclusion of law of the special master . . . [are]
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . .”
42 U.S.C. § 300aa-12(e)(2)(B); see also Lombardi v. Sec’y of Health & Human Servs.,
656 F.3d at 1350 (“We uphold the special master's findings of fact unless they are arbitrary
or capricious.”) (internal citations omitted); Moberly ex rel. Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Markovich v. Sec’y of Health &
Human Servs., 477 F.3d at 1356-57; Lampe v. Sec’y of Health & Human Servs., 219 F.3d
at 1360. The United States Court of Appeals for the Federal Circuit has indicated that:
These standards vary in application as well as degree of deference. Each
standard applies to a different aspect of the judgment. Fact findings are
reviewed by us, as by the Claims Court judge, under the arbitrary and
capricious standard; legal questions under the “not in accordance with law”
standard . . . ; and discretionary rulings under the abuse of discretion
standard. The latter will rarely come into play except where the special
master excludes evidence.
Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d at 871 n.10; see also Carson
ex rel. Carson v. Sec’y of Health & Human Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013);
Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1366; W.C.
v. Sec’y of Health & Human Servs., 704 F.3d at 1355; Griglock v. Sec’y of Health &
Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012); Porter v. Sec’y of Health & Human
Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011) (citing Broekelschen v. Sec’y of Health &
Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010)) (explaining that the reviewing court
“do[es] not reweigh the factual evidence, assess whether the special master correctly
evaluated the evidence, or examine the probative value of the evidence or the credibility
of the witnesses—these are all matters within the purview of the fact finder”); Dodd v.
18
Sec’y of Health & Human Servs., 114 Fed. Cl. at 56. “With regard to both fact-findings
and fact-based conclusions, the key decision maker in the first instance is the special
master. The Claims Court owes these findings and conclusions by the special master
great deference – no change may be made absent first a determination that the special
master was ‘arbitrary and capricious.’” Munn v. Sec’y of Health & Human Servs., 970 F.2d
at 870; see also 42 U.S.C. § 300aa-12(e)(2)(B).
Generally, “if the special master ‘has considered the relevant evidence of record,
drawn plausible inferences and articulated a rational basis for the decision, reversible
error will be extremely difficult to demonstrate.’” Hibbard v. Sec’y of Health & Human
Servs., 698 F.3d at 1363 (quoting Hines on Behalf of Sevier v. Sec’y of Dep’t of Health &
Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)); see also Porter v. Sec’y of Health
& Human Servs., 663 F.3d at 1253-54; Lampe v. Sec’y of Health & Human Servs., 219
F.3d at 1360; Avila ex rel. Avila v. Sec’y of Health & Human Servs., 90 Fed. Cl. 590, 594
(2009); Dixon v. Sec’y of Health & Human Servs., 61 Fed. Cl. 1, 8 (2004) (“The court’s
inquiry in this regard must therefore focus on whether the special master examined the
‘relevant data’ and articulated a ‘satisfactory explanation for its action including a “rational
connection between the facts found and the choice made.” (quoting Motor Vehicle Mfrs.
Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (quoting Burlington Truck
Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)))).
As noted by the United States Court of Appeals for the Federal Circuit:
Congress assigned to a group of specialists, the special masters within the
Court of Federal Claims, the unenviable job of sorting through these painful
cases and, based upon their accumulated expertise in the field, judging the
merits of the individual claims. The statute makes clear that, on review, the
Court of Federal Claims is not to second guess the special masters [sic]
fact-intensive conclusions; the standard of review is uniquely deferential for
what is essentially a judicial process. Our cases make clear that, on our
review . . . we remain equally deferential. That level of deference is
especially apt in a case in which the medical evidence of causation is in
dispute.
Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1366 (quoting
Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993))
(modification in original); Hibbard v. Sec’y of Health & Human Servs., 698 F.3d at 1363;
Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1380 (Fed. Cir. 2012). The
Court of Appeals for the Federal Circuit has further explained that the reviewing courts
“‘do not sit to reweigh the evidence. [If] the special master's conclusion [is] based on
evidence in the record that [is] not wholly implausible, we are compelled to uphold that
finding as not being arbitrary and capricious.’” See Deribeaux ex rel. Deribeaux v. Sec’y
of Health & Human Servs., 717 F.3d at 1367 (quoting Lampe v. Sec’y of Health & Human
Servs., 219 F.3d at 1363) (modification in original); see also Hibbard v. Sec’y of Health &
Human Servs., 698 F.3d at 1363 (citing Cedillo v. Sec’y of Health & Human Servs., 617
F.3d 1328, 1338 (Fed. Cir. 2010)).
19
The Special Master has discretion to determine the relative weight of evidence
presented, including contemporaneous medical records and oral testimony. See Burns v.
Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (finding that the Special
Master had thoroughly considered evidence in record, had discretion not to hold an
additional evidentiary hearing); Hibbard v. Sec’y of Health & Human Servs., 698 F.3d at
1368 (finding it was not arbitrary or capricious for the Special Master to weigh diagnoses
of different treating physicians against one another, including when their opinions
conflict). “‘Clearly it is not then the role of this court to reweigh the factual evidence, or to
assess whether the special master correctly evaluated the evidence. And of course we
do not examine the probative value of the evidence or the credibility of the witnesses.
These are all matters within the purview of the fact finder.’” Dodd v. Sec’y of Health &
Human Servs., 114 Fed. Cl. at 56 (quoting Munn v. Sec'y of Dept. of Health & Human
Servs., 970 F.2d at 870 n.10); see also Rich v. Sec’y of Health & Human Servs., 129 Fed.
Cl. 642, 655 (2016); Paluck v. Sec'y of Health & Human Servs., 104 Fed. Cl. 457, 467
(2012) (“A special master's findings regarding the probative value of the evidence and the
credibility of witnesses will not be disturbed so long as they are ‘supported by substantial
evidence.’” (quoting Doe v. Sec'y of Health & Human Servs., 601 F.3d 1349, 1355 (Fed.
Cir.), cert. denied, 562 U.S. 1029 (2010))).
Additionally, a Special Master is “not required to discuss every piece of evidence
or testimony in [his or] her decision.” Snyder ex rel. Snyder v. Sec’y of Health & Human
Servs., 88 Fed. Cl. 706, 728 (2009); see also Paluck ex rel. Paluck v. Sec’y of Health &
Human Servs., 104 Fed. Cl. at 467 (“[W]hile the special master need not address every
snippet of evidence adduced in the case, see id. [Doe v. Sec’y of Health & Human Servs.,
601 F.3d at 1355], he cannot dismiss so much contrary evidence that it appears that he
‘simply failed to consider genuinely the evidentiary record before him.’” (quoting Campbell
v. Sec’y of Health & Human Servs., 97 Fed. Cl. 650, 668 (2011))).
With regard to the Special Master’s weighing of evidence when testimony conflicts
with contemporaneous medical records, the Special Master generally should afford
contemporaneous medical records greater weight than conflicting testimony offered after
the fact. Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d, 968
F.2d 1226 (Fed Cir. 1992) (citing United States v. United States Gypsum Co., 333 U.S.
364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with
contemporaneous documents is entitled to little evidentiary weight.”)). This is because
medical records created contemporaneously with the events they describe are presumed
to be accurate and complete. See Cucuras v. Sec’y of Health & Human Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993). The United States Court of Appeals for the Federal Circuit
has explained:
Medical records, in general, warrant consideration as trustworthy evidence.
The records contain information supplied to or by health professionals to
facilitate diagnosis and treatment of medical conditions. With proper
treatment hanging in the balance, accuracy has an extra premium. These
records are also generally contemporaneous to the medical events.
20
Id.
Nevertheless, there are situations when oral testimony may be more persuasive
than written records. For example, this may be so where medical records are inaccurate
or incomplete. See Campbell ex rel. Campbell v. Sec’y of Health & Human Servs., 69
Fed. Cl. 775, 779 (2006) (“[w]ritten records which are, themselves, inconsistent, should
be accorded less deference than those which are internally consistent. Records which
are incomplete may be entitled to less weight than records which are complete.” (quoting
Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. at 733)). Inconsistencies in medical
records may result from (1) a petitioner’s failure to recount to the medical professional
everything that happened during the relevant time period, (2) the medical professional’s
failure to document everything that petitioner told him or her, (3) a petitioner’s faulty
recollection of events when presenting testimony, or (4) a petitioner purposely recounting
symptoms that did not exist. See La Londe v. Sec’y of Health & Human Servs., 110 Fed.
Cl. 184, 203–04 (2013) aff’d 746 F.3d 1334 (Fed. Cir. 2014). There are “perfectly valid
reasons why [medical records] may not be complete.” Id. at 203 n.33. For example, “it
would not surprise the court if [Petitioner] did not recall, or recount to the pediatrician,
each and every symptom that she observed” given that Petitioner “had just endured a
sleepless, and undoubtedly terrifying, night caring for a child experiencing an anaphylactic
reaction . . . serious enough to cause the pediatrician to call for an ambulance . . . .” Id.
“Oral testimony that is inconsistent with medical records must be consistent, clear,
cogent and compelling to outweigh the medical records prepared for the purpose of
diagnosis and treatment.” Camery v. Sec'y of Dep't of Health & Human Servs., 42 Fed.
Cl. 381, 391 (1998). Thus, a determination regarding a witness’s credibility is needed
when determining the weight that such testimony should be afforded. Andreu v. Sec’y of
Health & Human Servs., 569 F .3d 1367, 1379 (Fed. Cir. 2009). “Such a determination of
credibility is uniquely within the purview of the special master.” Burns v. Sec'y of Dep't of
Health & Human Servs., 3 F.3d at 417 (special master did not err in accepting
contemporaneous medical records over the testimony of fact witnesses).
Regarding the causation analysis, as indicated by the United States Court of
Appeals for the Federal Circuit in Althen v. Secretary of Health and Human Services:
The [Vaccine] Act provides for the establishment of causation in one of two
ways: through a statutorily-prescribed presumption of causation upon a
showing that the injury falls under the Vaccine Injury Table (“Table injury”),
see 42 U.S.C. § 300aa-14(a); or where the complained-of injury is not listed
in the Vaccine Injury Table (“off-Table injury”), by proving causation in fact,
see 42 U.S.C. §§ 300aa-13(a)(1), -11(c)(1)(C)(ii)(I).
Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278; W.C. v. Sec'y of Health &
Human Servs., 704 F.3d at 1356; Broekelschen v. Sec'y of Health & Human Servs., 618
F.3d at 1346; Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1356 (Fed.
Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2006), cert. denied, 551 U.S. 1102 (2007);
21
Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. at 50; Paluck v. Sec'y of Health &
Human Servs., 104 Fed. Cl. at 467-68; Fesanco v. Sec’y of Health & Human Servs., 99
Fed. Cl. 28, 31 (2011). The United States Supreme Court has explained that:
Claimants who show that a listed injury first manifested itself at the
appropriate time are prima facie entitled to compensation. No showing of
causation is necessary; the Secretary bears the burden of disproving
causation. A claimant may also recover for unlisted side effects, and for
listed side effects that occur at times other than those specified in the Table,
but for those the claimant must prove causation.
Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228-229 (2011) (footnotes omitted); Kennedy v.
Sec’y of Health & Human Servs., 99 Fed. Cl. 535, 539 (2011), aff’d, 485 F. App’x. 435
(Fed. Cir. 2012).
As both parties recognize, the injuries Petitioner alleges A.C. suffered as a result
of the DTaP, HIB, MMR and Varicella vaccinations are not included on the Vaccine Injury
Table. See 42 U.S.C. § 300aa-14. Petitioner, therefore, must proceed under an off-Table
theory of recovery. Under the off-Table theory of recovery, a petitioner is entitled to
compensation if he or she can demonstrate, by a preponderance of the evidence, see 42
U.S.C. § 300aa-13(a)(1)(A), that the recipient of the vaccine sustained, or had
significantly aggravated, an illness, disability, injury, or condition not set forth in the
Vaccine Injury Table, but which was caused by a vaccine that is listed on the Vaccine
Injury Table. See 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(I); see also LaLonde v. Sec’y of Health
& Human Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014); W.C. v. Sec’y of Health & Human
Servs., 704 F.3d at 1356 (“Nonetheless, the petitioner must do more than demonstrate a
‘plausible’ or ‘possible’ causal link between the vaccination and the injury; he must prove
his case by a preponderance of the evidence.” (quoting Moberly ex rel. Moberly v. Sec’y
of Health & Human Servs., 592 F.3d at 1322)); Althen v. Sec’y of Health & Human Servs.,
418 F.3d at 1278; Hines on Behalf of Sevier v. Sec’y of Dep’t of Health & Human Servs.,
940 F.2d at 1525. While scientific certainty is not required, the Special Master “is entitled
to require some indicia of reliability to support the assertion of the expert witness.” Moberly
ex rel. Moberly ex rel. v. Sec’y of Health & Human Servs., 592 F.3d at 1324; see also
Hazlehurst v. Sec’y of Health & Human Servs., 88 Fed. Cl. 473, 439 (2009), aff’d, 604
F.3d 1343 (Fed. Cir. 2010) (quoting Andreu ex rel. Andreu v. Sec’y of Health & Human
Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009)).
Additionally, Petitioner must prove causation-in-fact. See Grant v. Sec'y of Health
& Human Servs., 956 F.2d 1144, 1147-48 (Fed. Cir. 1992). The United States Court of
Appeals for the Federal Circuit has held that causation-in-fact in the Vaccine Act context
is the same as the “legal cause” in the general torts context. See Shyface v. Sec’y of
Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). Therefore, drawing from
the Restatement (Second) of Torts, the vaccine is a cause-in-fact when it is “a substantial
factor in bringing about the harm.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d
at 1351 (quoting the Restatement (Second) of Torts § 431(a)); see also Deribeaux ex rel.
Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1367 (“To prove causation, a
22
petitioner must show that the vaccine was ‘not only a but-for cause of the injury but also
a substantial factor in bringing about the injury.’” (quoting Shyface v. Sec’y of Health &
Human Servs., 165 F.3d at 1352–53)). A “‘substantial factor’ standard requires a greater
showing than ‘but for’ causation.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d
at 1351 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d at 1352).
“However, the petitioner need not show that the vaccine was the sole or predominant
cause of her injury, just that it was a substantial factor.” Id. (citing Walther v. Sec'y of
Health & Human Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007)). A Judge of the United
States Court of Federal Claims has explained the relationship between “but-for” causation
and “substantial factor” causation in our court’s decision in Deribeaux ex rel. Deribeaux
v. Secretary of Health and Human Services:
The de Bazan [de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at
1351] court defined but-for causation as requiring that “the harm be
attributable to the vaccine to some nonnegligible degree,” and noted that,
although substantial is somewhere beyond the low threshold of but-for
causation, it does not mean that a certain factor must be found to have
definitively caused the injury. Id. [de Bazan v. Sec’y of Health & Human
Servs., 539 F.3d at 1351] Accordingly, a factor deemed to be substantial is
one that falls somewhere between causing the injury to a non-negligible
degree and being the “sole or predominant cause.” Id.
This definition of substantial—somewhere between non-negligible and
predominant—is applicable to respondent's burden to prove a sole
substantial factor unrelated to the vaccine. Accordingly, a respondent's
burden is to prove that a certain factor is the only substantial factor—one
somewhere between non-negligible and predominant—that caused the
injury.
Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 105 Fed. Cl. 583, 595
(2012), aff’d, 717 F.3d 1363 (Fed. Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2013)
(emphasis in original).
As indicated above, a petitioner must prove his or her case by a preponderance of
the evidence. See 42 U.S.C. § 300aa-13(a)(1)(A). According to the United States Court
of Appeals for the Federal Circuit, the preponderance of evidence standard is “one of
proof by a simple preponderance, of ‘more probable than not causation.’” Althen v. Sec’y
of Health & Human Servs., 418 F.3d at 1279-80 (citing concurrence in Hellebrand v. Sec’y
of Dep’t of Health & Human Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993)); see also
W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1356 (“In this off-table case, the
petitioner must show that it is ‘more probable than not’ that the vaccine caused the injury.”
(quoting Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1279-80)). A petitioner
who meets this burden is then entitled to recovery under the Vaccine Act, unless the
respondent proves by preponderant evidence that the injury was caused by factors
unrelated to the vaccine. See Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373,
1379-80 (Fed. Cir. 2012); see also Rus v. Sec’y of Health & Human Servs., 129 Fed. Cl.
23
672, 680 (2016) (citing 42 U.S.C. § 300aa-13(a)(1)(B); Shalala v. Whitecotton, 514 U.S.
268, 270-71 (1995)); Walther v. Sec’y of Health & Human Servs., 485 F.3d at 1151. “But,
regardless of whether the burden of proof ever shifts to the respondent, the special master
may consider the evidence presented by the respondent in determining whether the
petitioner has established a prima facie case.” Rus v. Sec’y of Health & Human Servs.,
129 Fed. Cl. at 680 (citing Stone v. Sec’y of Health & Human Servs., 676 F.3d at 1379;
de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1353).
For Petitioner to establish a prima facie case in a vaccine case, decisions of the
Federal Circuit permit the use of circumstantial evidence, which the court described as
“envisioned by the preponderance standard” and by the vaccine system created by
Congress, in which “close calls regarding causation are resolved in favor of injured
claimants” without the need for medical certainty. See Althen v. Sec’y of Health & Human
Servs., 418 F.3d at 1280; see also Cloer v. Sec’y of Health & Human Servs., 654 F.3d
1322, 1332 n.4 (Fed. Cir. 2011), cert. denied, 566 U.S. 956 (2012); Andreu ex rel. Andreu
v. Sec’y of Health & Human Servs., 569 F.3d at 1379 (“In Althen, however, we expressly
rejected the Stevens test, concluding that requiring ‘objective confirmation’ in the medical
literature prevents ‘the use of circumstantial evidence . . . and negates the system created
by Congress’ through the Vaccine Act.”) (modification in original); La Londe v. Sec’y of
Health & Human Servs., 110 Fed. Cl. at 198 (“Causation-in-fact can be established with
circumstantial evidence, i.e., medical records or medical opinion.”). The Althen court
further noted that “the 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.” Id. (citing Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs.,
35 F.3d 543, 549 (Fed. Cir. 1994)); see also W.C. v. Sec’y of Health & Human Servs.,
704 F.3d at 1356. When proving eligibility for compensation for an off-Table injury under
the Vaccine Act, however, Petitioner may not rely on her testimony alone. According to
the Vaccine Act, “[t]he special master or court may not make such a finding based on the
claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.”
42 U.S.C. § 300aa-13(a)(1).
The Federal Circuit in Althen defined a three-prong test which a petitioner must
meet to establish causation in an off-Table injury case:
To meet the preponderance standard, [petitioner] must “show a medical
theory causally connecting the vaccination and the injury.” Grant v. Sec'y
of Health & Humans Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (citations
omitted). 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[.]” Grant, 956 F.2d at 1148. [Petitioner] may
recover if she shows “that the vaccine was not only a but-for cause of the
injury but also a substantial factor in bringing about the injury.” Shyface, 165
F.3d at 1352-53. Although probative, neither a mere showing of a proximate
temporal relationship between vaccination and injury, nor a simplistic
24
elimination of other potential causes of the injury suffices, without more, to
meet the burden of showing actual causation. See Grant, 956 F.2d at 1149.
Concisely stated, [petitioner’s] burden is to 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.
Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278 (brackets in original); see
also Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1367;
Porter v. Sec’y of Health & Human Servs., 663 F.3d at 1249; Moberly ex rel. Moberly v.
Sec’y of Health & Human Servs., 592 F.3d at 1322; Pafford v. Sec’y of Health & Human
Servs., 451 F.3d at 1355; Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317,
1324 (Fed. Cir. 2006); C.K. v. Sec’y of Health & Human Servs., 113 Fed. Cl. 757, 766
(2013).
With regard to the first Althen prong, “a medical theory causally connecting the
vaccination and the injury,” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278,
the Federal Circuit in Althen analyzed the preponderance of evidence requirement as
allowing medical opinion as proof, even without scientific studies in medical literature that
provide “objective confirmation” of medical plausibility. Id. at 1278, 1279-80; see also
Shapiro v. Sec’y of Health & Human Servs., 105 Fed. Cl. at 358. In rejecting a requirement
that a claimant under the Vaccine Act prove confirmation of medical plausibility from the
medical community and medical literature, the Althen court turned to the analysis
undertaken in Knudsen ex rel. Knudsen v. Secretary of Health and Human Services, 35
F.3d at 549. See Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1279-80. In
Knudsen ex rel. Knudsen v. Secretary of Health and Human Services, the United States
Court of Appeals for the Federal Circuit wrote, “to require identification and proof of
specific biological mechanisms would be inconsistent with the purpose and nature of the
vaccine compensation program. The Vaccine Act does not contemplate full blown tort
litigation in the Court of Federal Claims.” Knudsen ex rel. Knudsen v. Sec’y of Health &
Human Servs., 35 F.3d at 549. The Federal Circuit in Knudsen stated further:
[t]he Court of Federal Claims is therefore not to be seen as a vehicle for
ascertaining precisely how and why DTP and other vaccines sometimes
destroy the health and lives of certain children while safely immunizing most
others. This research is for scientists, engineers, and doctors working in
hospitals, laboratories, medical institutes, pharmaceutical companies, and
government agencies. The special masters are not “diagnosing” vaccine-
related injuries. The sole issues for the special master are, based on the
record evidence as a whole and the totality of the case, whether it has been
shown by a preponderance of the evidence that a vaccine caused the
[petitioner’s] injury or that the [petitioner’s] injury is a table injury, and
whether it has not been shown by a preponderance of the evidence that a
25
factor unrelated to the vaccine caused the child's injury. See 42 U.S.C.
§ 300aa-13(a)(1), (b)(1).
Id. (brackets added).
The Federal Circuit also has indicated that:
Although a finding of causation “must be supported by a sound and reliable
medical or scientific explanation,” causation “can be found in vaccine
cases . . . without detailed medical and scientific exposition on the biological
mechanisms.” Knudsen v. Sec'y of the Dep't of Health & Human Servs., 35
F.3d 543, 548-49 (Fed. Cir. 1994). It is not necessary for a petitioner to point
to conclusive evidence in the medical literature linking a vaccine to the
petitioner's injury, as long as the petitioner can show by a preponderance
of the evidence that there is a causal relationship between the vaccine and
the injury, whatever the details of the mechanism may be.
Simanski v. Sec'y of Health & Human Servs., 671 F.3d 1368, 1384 (Fed. Cir. 2012)
(omission in original).
The second prong of the Althen test requires the petitioner to demonstrate “a
logical sequence of cause and effect, showing that the vaccination was the reason for the
injury” by a preponderance of the evidence. Althen v. Sec'y of Health & Human Servs.,
418 F.3d at 1278; see also Pafford v. Sec’y of Health & Human Servs., 451 F.3d at 1355.
In order to prevail, the petitioner must show “that the vaccine was not only a but-for cause
of the injury but also a substantial factor in bringing about the injury.” Althen v. Sec'y of
Health & Human Servs., 418 F.3d at 1278 (quoting Shyface v. Sec’y of Health & Human
Servs., 165 F.3d at 1352). In Capizzano v. Secretary of Health and Human Services, 440
F.3d at 1326, the Federal Circuit stated, “‘[a] logical sequence of cause and effect’ means
what it sounds like – the claimant's theory of cause and effect must be logical. Congress
required that, to recover under the Vaccine Act, a claimant must prove by a
preponderance of the evidence that the vaccine caused his or her injury.” Capizzano v.
Sec'y of Health & Human Servs., 440 F.3d at 1326 (quoting 42 U.S.C. §§ 300aa-11(c)(1)
– 13(a)(1) (2006)); see also Cozart v. Sec’y of Health & Human Servs., 126 Fed. Cl. 488,
498 (2016) (quoting Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278).
The third prong of the Althen test requires the petitioner to demonstrate, by a
preponderance of evidence, “a proximate temporal relationship between vaccination and
injury.” Althen v. Sec'y of Health & Human Servs., 418 F.3d at 1278. The United States
Court of Appeals for the Federal Circuit emphasized the importance of a temporal
relationship in Pafford v. Secretary of Health and Human Services, when it noted that,
“without some evidence of temporal linkage, the vaccination might receive blame for
events that occur weeks, months, or years outside of the time in which scientific or
epidemiological evidence would expect an onset of harm.” Pafford v. Sec'y of Health &
Human Servs., 451 F.3d at 1358. Requiring evidence of strong temporal linkage is
consistent with the third requirement articulated in Althen because “[e]vidence
demonstrating petitioner’s injury occurred within a medically acceptable time frame
26
bolsters a link between the injury alleged and the vaccination at issue under the ‘but-for’
prong of the causation analysis.” Id. (citing Capizzano v. Sec’y of Health & Human Servs.,
440 F.3d at 1326). The Pafford court further explained,
[i]f, for example, symptoms normally first occur ten days after inoculation
but petitioner's symptoms first occur several weeks after inoculation, then it
is doubtful the vaccination is to blame. In contrast, if symptoms normally
first occur ten days after inoculation and petitioner's symptoms do, in fact,
occur within this period, then the likelihood increases that the vaccination is
at least a factor. Strong temporal evidence is even more important in cases
involving contemporaneous events other than the vaccination, because the
presence of multiple potential causative agents makes it difficult to attribute
"but-for" causation to the vaccination. After all, credible medical expertise
may postulate that any of the other contemporaneous events may have
been the sole cause of the injury.
Pafford v. Sec'y of Health & Human Servs., 451 F.3d at 1358. A petitioner must offer
“preponderant proof that the onset of symptoms occurred within a timeframe which, given
the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1352. Determining
what constitutes a medically appropriate timeframe, thus, is linked to the petitioner’s
theory of how the vaccine can cause petitioner’s injury. See id.; see also K.T. v. Sec’y of
Health & Human Servs., 132 Fed. Cl. 175, 186 (2017); Shapiro v. Sec’y of Health &
Human Servs., 101 Fed. Cl. 542, 542 (2011).
According to the court in Capizzano v. Secretary of Health and Human Services,
evidence used to satisfy one of the Althen prongs may overlap with and be used to satisfy
another prong. Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326 (“We see
no reason why evidence used to satisfy one of the Althen III [Althen v. Sec’y of Health &
Human Servs., 418 F.3d at 1274] prongs cannot overlap to satisfy another prong.”). If a
petitioner satisfies the Althen burden and meets all three prongs of the test, the petitioner
prevails, “unless the [government] shows, also by a preponderance of the evidence, that
the injury was in fact caused by factors unrelated to the vaccine.” Knudsen ex rel.
Knudsen v. Sec'y of Health & Human Servs., 35 F.3d at 547 (brackets in original;
quotation omitted).
In her Motion For Review, Petitioner challenges the Special Master’s December
14, 2016 Ruling On Onset, in which the Special Master found that A.C.’s onset of
symptoms occurred in January 2013, as evidenced by the medical records, submitted by
Petitioner. Petitioner argues “that the testimony of A.C.’s parents[ 10] and the affidavits
submitted by independent witnesses regarding the onset of A.C.’s symptoms are
10 Although Petitioner refers here to “A.C.’s parents,” the record demonstrates that A.C.’s
father did not testify at the July 11, 2016 fact hearing, nor did he submit an affidavit. A.C.’s
mother, Petitioner Heather Caron, was the only parent of A.C. to provide testimony in this
case.
27
sufficient to overcome the rebuttable presumption that the information contained in the
medical records is accurate.” Petitioner then argues that the December 14, 2016 Ruling
On Onset also “denied [her] the opportunity to even present evidence to meet her burden”
of proving causation under the Act. In particular, Petitioner alleges that because of the
Special Master’s December 14, 2016 finding of a January 2013 onset, Petitioner “was
unable to secure an expert opinion regarding [sic] relationship between the administration
of the vaccinations and an onset of symptoms that long after the vaccinations.” Petitioner
also argues that the Special Master’s September 7, 2017 Decision Denying Entitlement,
which resulted in her petition for compensation being dismissed, should be “set aside”
and that she “should be allowed to pursue obtaining an expert opinion consistent with this
evidence and have an evidentiary hearing to establish whether she is entitled to
compensation.”
The government responds that the Special Master “thoroughly reviewed and
evaluated the evidence as a whole and properly concluded that the onset of AC’s CRMO
occurred in January 2013, and that petitioner failed to offer a persuasive medical theory
causally connecting the vaccinations and AC’s alleged injury.” In particular, the
government argues that “[i]n order for the special master to have concluded that AC’s
symptoms began earlier, she would be required to find that either petitioner consistently
misreported the onset of AC’s symptoms or that all of the medical providers affiliated with
various institutions inaccurately recorded the same incorrect onset of January 2013.” As
noted above, the government argues that “[t]his conclusion strains reason.”
“With regard to both fact-findings and fact-based conclusions, the key decision
maker in the first instance is the special master.” Munn v. Sec’y of Health & Human Servs.,
970 F.2d at 870. The reviewing Court of Federal Claims judge owes the findings of the
Special Master great deference, and the court should not overrule the Special Master
absent a determination that the Special Master acted arbitrarily, capriciously, or against
the law. See id. This court “must therefore focus on whether the Special Master examined
the relevant data and articulated a satisfactory explanation for [his or her] action including
a rational connection between the facts found and the choice made.” Dixon v. Sec’y of
Dep’t of Health & Human Servs., 61 Fed. Cl. at 8 (internal quotations omitted). For
example, in Cucuras v. Secretary of Department of Health and Human Services, to which
Special Master Roth cited and discussed in her December 14, 2016 Ruling On Onset, the
Cucuras Special Master, “after considering the record as a whole,” determined that two
contemporaneous medical records, which indicated a later onset, were more persuasive
than the Cucuras Petitioners’ testimony that their child’s seizures began within one day
of her vaccinations. Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 542
(1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993). The reviewing judge held that the Special
Master’s finding of a later than alleged onset documented by contemporaneous medical
records was not arbitrary or capricious and that the Special Master’s conclusion that the
Cucuras Petitioners’ testimony did not overcome the medical record evidence was
reasonable. The Cucuras court explained:
In light of this concern for Nicole’s treatment and petitioners’ specific
suspicion that the DTP was implicated in causing Nicole’s problems, it
28
strains reason to conclude that petitioners would fail to accurately report the
onset of their daughter's symptoms. It is equally unlikely that pediatric
neurologists, who are trained in taking medical histories concerning the
onset of neurologically significant symptoms, would consistently but
erroneously report the onset of seizures a week after they in fact occurred.
Id. at 543.
In the case currently before the court, the record demonstrates that Special Master
Roth “examined” Petitioner’s sworn testimony, as well as the affidavits of the four family
members, and Petitioner’s reconstructed date book, submitted by the Petitioner. Once
assigned to the case after Special Master Hamilton-Fieldman, Special Master Roth
ordered and held an evidentiary hearing regarding onset and heard Petitioner’s testimony
that A.C.’s onset of symptoms began during the fall of 2012. Following Petitioner’s
presentation at the July 11, 2016 fact hearing, Special Master Roth also further
questioned Petitioner about A.C.’s condition and medical visits after receiving the
allegedly causal vaccinations. The government did not cross-examine Petitioner and
Petitioner was the only person to testify at the evidentiary hearing.
In her Ruling On Onset, Special Master Roth noted that Petitioner’s evidence of a
fall 2012 onset conflicted with the contemporaneous medical records which established
a January 2013 onset. See Caron v. Sec’y of Health & Human Servs., 2016 WL 7664309,
at *1. In her Ruling On Onset, Special Master Roth individually reviewed Petitioner’s
affidavits and the four affidavits from relatives. See id. at *9-11. She also carefully
reviewed Petitioner’s testimony at the July 11, 2016 onset fact hearing. See id. at *11-13.
The Special Master noted that Petitioner did not submit an affidavit from her husband or
from Dixy Love-O’Neill, the individual who, according to Petitioner, A.C. allegedly visited
on October 15, 2012 and to whom A.C. allegedly complained to about his foot pain. See
id. at *11. The Special Master also stated: “Of the affidavits submitted, none was based
on an independent recollection of the events. Everyone relied upon the date book that
had been provided to them by Ms. Caron.” Id. at *11. The Special Master specifically
explained in her Ruling:
Each of these individuals based their recall of the events on a “date book”
provided to them by Ms. Caron. At the Hearing, Ms. Caron confirmed that
she went back to her date book almost two years later and added the details
upon which the affiants relied in drafting their Affidavits. Tr. 10.2. to 10.9.
None of these individuals testified at Hearing.
Id. at *10.
The Special Master also indicated in her Ruling On Onset why she found that
Petitioner’s evidence did not overcome the presumption in favor of the contemporaneous
medical records. Special Master Roth explained:
29
Ms. Caron showed no hesitation in seeking medical intervention for A.C.
when he was ill, hurt or even had large bug bites. Ms. Caron is a vigilant
mother who routinely took A.C. to the pediatrician for any and all health
related issues. To that end, the medical records document that A.C. began
having pain in his foot in January and that Ms. Caron took him to the
pediatrician with that complaint. . . . [I]t strains reason to conclude that
petitioner would fail to accurately report the onset of A.C.’s symptoms to his
physicians. It is equally unlikely that all of the various doctors that saw A.C.,
who are presumably trained in taking medical histories, would fail to
document or would inaccurately document the mother’s complaints of onset
of his condition.
See id. at *15.
The record before this court supports the Special Master’s Ruling On Onset and
demonstrates that the Special Master rationally explained and concluded that Petitioner’s
testimony and multiple affidavits, affidavits of relatives and friends, and her date book do
not overcome the presumption in favor of the information contained in the
contemporaneous medical records. See Carson ex rel. Carson v. Sec’y of Health &
Human Servs., 727 F.3d at 1369; see also Porter v. Sec'y of Health & Human Servs., 663
F.3d at 1253-54; Munn v. Sec’y of Health & Human Servs., 970 F.2d at 870. The record
establishes that Petitioner as a vigilant mother, took A.C. to the pediatrician’s office over
forty times during A.C.’s first three years of life. She also took A.C. to the emergency
room. For instance, when A.C. was two years old, Petitioner took A.C. to the emergency
room after falling forward and cutting his forehead with his toy train. Shortly after that visit,
Petitioner took A.C. to the emergency room again for a cough and sinus congestion,
because Petitioner was unable to get A.C. in to see his primary care physician.
Petitioner’s pattern was, repeatedly, to seek medical attention for her son’s health issues.
The record before the Special Master and this court demonstrates that Petitioner did not
seek medical treatment for A.C.’s alleged vaccine related symptoms until January 2013,
almost five months after the administration of the vaccines on August 2, 2012. The
contemporaneous record supports a finding that A.C.’s alleged vaccine related onset of
symptoms began in January 2013, and that his mother sought medical attention for those
symptoms at that time.
The medical records consistently reflect a January 2013 onset of the symptoms
allegedly caused by the August 2, 2012 vaccinations. Notably, none of the medical
records of the various medical providers who A.C. saw prior to January 2013 documented
information that support a fall 2012 onset. For example, on April 2, 2013, A.C.’s
rheumatologist noted that “[h]e was well until January [2013] when he started complaining
of pain in the right foot and ankle.” During A.C.’s April 2013 hospital stay, the pediatric
oncologist noted that “[i]n January of 2013 [complaining of] intermittent pain in foot. Pain
self resolved. Pain reoccurred And seen by orthopedics.” During that same hospital stay,
the resident pediatric specialist also stated that “[m]om reports that in January, he had
right foot with limping . . . Symptoms resolved within 1 week.” The pediatric infectious
disease consult in April 2013 also noted that “[t]he history was obtained from mother. . . .
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[A.C.] was in his typical state of health until mid January when he began to have pain of
his right foot and ankle.” There is no evidence in the records before the court that
Petitioner told, or that A.C.’s medical providers found, that A.C.’s symptoms began earlier
than January 2013, in fact, to the contrary.
The only indication of a fall 2012 onset comes from Petitioner’s own testimony and
affidavits, her reconstructed date book, and the four affidavits provided by relatives of
A.C., which all are dependent on Petitioner’s version of the alleged dates regarding A.C.’s
alleged symptoms before January 2013. As Special Master Roth noted in her Ruling On
Onset, none of the four affiants can independently remember the dates when A.C. visited
them and presented with symptoms. They all attested that they could only remember the
specific dates of A.C.’s visits because “Heather Caron apparently maintained a date book
with dates” and that she “recently shared that date book with me.” As discussed above,
A.C.’s mother admitted she did not note A.C.’s alleged complaints of vaccine related
injuries in the 2012 date book contemporaneously with the alleged events. Petitioner
wrote in her notes regarding A.C.’s alleged complaints in the 2012 date book
approximately two years later in 2014. According to the Vaccine Act, regarding a finding
of when onset occurred, “[t]he special master or court may not make such a finding based
on the claims of a petitioner alone, unsubstantiated by medical records or by medical
opinion.” 42 U.S.C. § 300aa-13(a)(1). The Special Master’s explanation and conclusion
that Petitioner’s evidence did not outweigh the presumption in favor of the accuracy of
medical records was not arbitrary, capricious, an abuse of discretion or contrary to law.
Likewise, the Special Master’s finding that A.C.’s onset of symptoms occurred in January
2013, as documented by the medical records, was not arbitrary, capricious, an abuse of
discretion or contrary to law. See Burns v. Sec’y of Dep’t of Health & Human Servs., 3
F.3d at 417; see also Cucuras v. Sec’y of Health & Human Servs., 993 F.2d at 1528; see
also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. at 734.
This court is tasked upon review of a Special Master’s decision, to determine
whether Special Master Roth “examined the relevant data and articulated a satisfactory
explanation for its action including a rational connection between the facts found and the
choice made,” Dixon v. Sec’y of Dep’t of Health & Human Servs., 61 Fed. Cl. at 8 (internal
citations omitted), not to reweigh the evidence. See Dodd v. Sec’y of Health & Human
Servs., 114 Fed. Cl. at 56. As discussed above, the record demonstrates that Special
Master Roth held an onset hearing and thereafter carefully examined the medical records
as well as the evidence submitted by Petitioner. She rationally concluded that Petitioner’s
testimony and her affidavits submitted in this case did not overcome the presumption in
favor of the contemporaneous medical records in the record before the court. Therefore
the Special Master’s ruling of a January 2013 onset was not arbitrary, capricious, an
abuse of discretion or contrary to law.
Petitioner also alleges that she has been “denied the opportunity to even present
evidence to meet her burden by the Special Master’s decision regarding onset of
symptoms” and continues to request the opportunity to “obtain[] an expert opinion
consistent with this evidence and have an evidentiary hearing to establish whether she is
entitled to compensation.” In her Ruling On Onset, Special Master Roth ordered that any
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Petitioner’s expert would be required to “rely on the facts as I have found them in this
Ruling [On Onset].” Caron v. Sec’y of Health & Human Servs., 2016 WL 7664309, at *15.
Special Master Roth also stated in her Ruling On Onset that “[i]n crafting their expert
report, no expert may rely on Ms. Caron’s testimony, affidavit, or the affidavits submitted
by the various individuals who relied solely on Ms. Caron’s date book for their
recollections of events.” Id.
It is well-established under Vaccine Rule 3(b) (2017) that the Special Master has
the duty to conduct the proceedings and “endeavor[]” to make them “expeditious, flexible,
and less adversarial, while at the same time affording each party a full and fair opportunity
to present its case and creat[e] a record sufficient to allow review of the special master’s
decision.” Vaccine Rule 3 (b)(2). Moreover, pursuant to Vaccine Rule 3(b), “[a] special
master . . . has wide discretion in conducting proceedings in a case.” Burns v. Sec’y of
Health & Human Servs., 3 F.3d at 417 (citing Vaccine Rule 3(b)). The Special Master also
has broad discretion under Vaccine Rule 8 to “determine the format for taking evidence
and hearing argument based on the specific circumstances of each case and after
consultation with the parties.” Vaccine Rule 8(a) (2017). In doing so, the Special Master
“must consider all relevant and reliable evidence governed by principles of fundamental
fairness to both parties.” Vaccine Rule 8(b)(1); see also Campbell ex rel. Campbell v.
Sec’y of Health & Human Servs., 69 Fed. Cl. at 778 (The concept of “fundamental
fairness” incorporated into Vaccine Rule 3(b) “surely entails notice and an effective
opportunity to be heard at a meaningful time and in a meaningful manner.”). “Plainly,
Vaccine Rules 3(b) and 8(c) together contemplate fundamental due process rights that
the Special Masters ought to observe in all proceedings.” Boley v. Sec’y of Health &
Human Servs., 82 Fed. Cl. 407, 413 (2008). “Although it has been held that this
fundamental fairness concept does not incorporate the rigors of the Federal Rules of
Evidence . . . it plainly requires a search for the truth, . . . .” Campbell ex rel. Campbell v.
Sec’y of Health & Human Servs., 69 Fed. Cl. at 778 (internal citations omitted). “Moreover,
consistent with due process, this fairness surely entails notice and an effective opportunity
to be heard at a meaningful time and in a meaningful manner.” Id.
For example, the Federal Circuit has found that it was proper for a Special Master
not to hear oral, expert medical testimony when the expert’s opinion was “based . . . on
facts not substantiated by the record.” See Burns v. Sec’y of Health & Human Servs., 3
F.3d at 416-17. Moreover, the Federal Circuit has approved of a Special Master’s decision
to forego any expert testimony and decide a case solely on the written record. See D’Tiole
v. Sec’y of Health & Human Servs., 132 Fed Cl. 421, 434 (2017) (finding that the Special
Master did not violate Vaccine Rule 3(b) when he decided not to hold an evidentiary
hearing on an otherwise fully developed record); Murphy v. Sec’y of Health & Human
Servs., 23 Cl. Ct. at 730 (finding that, if the Special Master finds that the written record is
fully developed, the Special Master may decide the case without an evidentiary hearing,
notwithstanding the desires of one or both of the parties). In contrast, the court in
Campbell ex rel. Campbell v. Secretary of Health and Human Services, 69 Fed. Cl. 775,
780 (2006), found that the Special Master violated Vaccine Rules 3 and 8 when she
declined to hold an evidentiary hearing “in light of the other actions she took,” which
included the following: the Special Master “made short shrift” of petitioner’s affidavit “even
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though the various medical records . . . disagree on basic facts, such as when [Petitioner’s
child] had her fever(s) in relation to her seizures,” id. at 780; the Special Master, despite
the “fuzziness” of the medical records, “wielded these records as if they were crystal
clear,” id.; the Special Master introduced internet articles on afebrile seizures “sua sponte
into the record shortly before rendering her decision” that “do not—at least on their face—
remotely meet this reliability requirement” under Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 597 (1993). Id.
Contrary to Petitioner’s allegation, Special Master Roth acted within her discretion
under Vaccine Rules 3(b) and 8 when she determined that based on the record before
the court, and after holding a hearing on the date of onset, that Petitioner’s expert must
rely on the Special Master’s the ruling that onset was January 2013 and that an earlier
date was not supported by the record. See Burns v. Sec’y of Health & Human Servs., 3
F.3d at 417 (the Special Master properly rejected the testimony of petitioner’s expert after
concluding that “the expert based his opinion on facts not substantiated by the record.”).
Special Master Roth stated:
Petitioner has not put forward evidence sufficient to refute the
contemporaneous medical records, which firmly support the onset of CRMO
in January 2013. I have carefully and meticulously reviewed the record.
Consistent with the foregoing, I find that A.C.’s symptoms of CRMO began
in January of 2013, five months after his vaccinations of August 2, 2012.
Caron v. Sec’y of Health & Human Servs., 2016 WL 7664309, at *15.
In this case, Petitioner had multiple opportunities to present her case and support
her allegations regarding the timing of A.C.’s onset of symptoms. See Vaccine Rule
3(b)(2). First, Special Master Hamilton-Fieldman, who initially presided over this case,
requested from Petitioner additional evidence to establish Petitioner’s version of a fall
2012 onset. Petitioner responded by providing to Special Master Hamilton-Fieldman her
supplemental affidavit, four affidavits from A.C.’s relatives, and her reconstructed date
book. Petitioner argued that A.C. presented with symptoms on five separate occasions
throughout the fall of 2012 while visiting and/or staying with relatives and friends.
Petitioner also alleged that the reason she and her husband delayed in seeking medical
attention for A.C. until January 2013 was because “the symptoms did not appear to be
significant” at the time. The four affiants on whom Petitioner tried to rely similarly alleged
that A.C. presented with some symptoms during the fall of 2012, based on reviewing
Petitioner’s date book.
Next, Special Master Hamilton-Fieldman ordered Petitioner to submit a “brief
regarding the alleged timing of onset” that shall “address the undersigned’s concerns
regarding the reliability of the evidence in support of the earlier alleged onset.” In
response, however, Petitioner did not offer further evidence or explain why her evidence
supporting a fall 2012 onset was reliable. Petitioner simply stated that she “has offered
multiple affidavits in support of the onset of A.C.’s symptoms” and “that those affidavits
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are overwhelmingly more persuasive than the medical records regarding the onset of
A.C.’s symptoms.”
Finally, Special Master Roth, to whom the case was reassigned, ordered and held
an “onset hearing” so that Petitioner could again have an opportunity to offer evidence
and “testify as to the onset of A.C.’s alleged injury.” At the hearing, Petitioner did not
present any witnesses besides herself. Petitioner testified about the various times,
according to Petitioner, A.C. presented with symptoms throughout the fall of 2012.
Petitioner also stated that she and her husband did not immediately seek medical
attention for A.C.’s foot pain because her husband was “very insistent” that A.C.’s
symptoms were “growing pains” and that they “weren’t going to take him to the doctor.”
So, according to Petitioner, she “had to listen” to her husband. Petitioner admitted at the
hearing that the handwritten notes in her 2012 date book documenting A.C.’s complaints
of foot pain were not contemporaneously made. Petitioner stated that she went back in
2014 to add to the date book regarding when A.C. complained about foot pain. She stated
that she could remember, despite it being almost two years later, the specific dates on
which he had complained because she “could remember those events and what was
going on that day.” Petitioner also did not submit additional evidence in advance of the
onset hearing with the exception of her own second supplemental affidavit. This affidavit
was identical to her previously filed supplemental affidavit except for the final paragraph,
which stated that “[t]he reason that we did not seek medical evaluation for several months
was due to a disagreement between me and my husband as to whether evaluation was
necessary.”
In her Ruling On Onset, issued after the hearing, Special Master Roth carefully
examined Petitioner’s evidence and appropriately explained that such evidence did not
overcome the presumption in favor of the information in the medical records, which
demonstrate a January 2013 onset. See Caron v. Sec’y of Health & Human Servs., 2016
WL 7664309, at *9-13; see also Cucuras v. Sec’y of Health & Human Servs., 993 F.2d at
1528. The Special Master noted that Petitioner was a “vigilant” mother who consistently
obtained timely medical care for her son. See Caron v. Sec’y of Health & Human Servs.,
2016 WL 7664309, at *15. The Special Master wrote in her ruling that it “strains reason”
to conclude that Petitioner would inaccurately report A.C.’s onset of symptoms to his
physicians at the time of the earlier visits or for his physicians to inaccurately document
Petitioner’s complaints of A.C.’s conditions. See id. The Special Master also noted that
the individuals who submitted affidavits in this case were Petitioner’s relatives and friends
and did not independently recollect the dates when A.C. visited them throughout the fall
of 2012, but, instead, relied on Petitioner’s reconstructed date book to refresh their
memories on the dates. Id. at *11. The Special Master also reiterated that Petitioner had
added to her date book the relevant handwritten notes regarding A.C.’s alleged
complaints of foot pain during the fall of 2012 two years later in 2014. See id. at *10.
Special Master Roth, therefore, found that Petitioner’s evidence did not overcome the
presumption in favor of the accuracy of the contemporaneous medical records and that
A.C.’s onset of symptoms was January 2013. Such findings by the Special Master reflect
the record and were not arbitrary, capricious, an abuse of discretion or contrary to law.
See Carson ex rel. Carson v. Sec’y of Health & Human Servs., 727 F.3d at 1369; see
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also Porter v. Sec’y of Health & Human Servs., 663 F.3d at 1253-54; Munn v. Sec’y of
Health & Human Servs., 970 F.2d at 870.
Petitioner alleges that she “has been denied the opportunity to even present
evidence to meet her burden by the Special Master’s decision regarding onset of
symptoms.” From the time she filed her petition for review in this court, Petitioner was free
to engage experts who were willing to offer opinions that the alleged injurious vaccinations
caused A.C.’s onset of symptoms. Even after Special Master Roth issued her Ruling On
Onset, Petitioner was still free to try to engage experts based on the medical records, but
as Special Master Roth ordered in her Ruling On Onset, any expert would be required to
“rely on the facts as I have found them in this Ruling,” and that “[i]n crafting their expert
report, no expert may rely on Ms. Caron’s testimony, affidavit, or the affidavits submitted
by the various individuals who relied solely on Ms. Caron’s date book for their
recollections of events.” Caron v. Sec’y of Health & Human Servs., 2016 WL 7664309, at
*15. As discussed above, Special Master Roth’s Ruling On Onset was not arbitrary,
capricious, an abuse of discretion or contrary to law. Further, also discussed above,
Special Master Roth acted within her discretion under Vaccine Rules 3(b) and 8 when
she ordered that any Petitioner’s expert would be required to “rely on the facts as I have
found them in this Ruling.” Id. Petitioner stated, however, in her Request For Ruling On
The Record and, similarly in her Motion For Review, that she was “unable to secure an
expert opinion regarding an onset of symptoms that long after the vaccinations,” not that
she was prevented to from doing so.
Moreover, since the initiation of proceedings in this court, Petitioner has not
provided any expert opinion showing that any of the vaccinations A.C. received can cause
CRMO, that the vaccinations did cause CRMO in this case, or to establish an earlier onset
date based on the record before the Special Master and the court. See Althen v. Sec'y of
Health & Human Servs., 418 F.3d at 1278 (Petitioner has the burden to prove the
vaccination at issue caused the injury by providing “(1) a medical theory causally
connecting the vaccination and the injury; (2) a logical sequence of cause and effect
showing that the vaccination was the reason for the injury; and (3) a showing of a
proximate temporal relationship between vaccination and injury.”).
Petitioner ultimately did attach two articles to her Request For Ruling On The
Record and then again in her Motion For Review in this court in an attempt to show that
she “could have likely established at a hearing that the vaccinations caused [A.C.’s]
osteomyelitis under the Althen standard.” These articles, however, do not assist Petitioner
to prove causation. The first article simply explains how vaccines work. The second five-
page article reports two cases of osteomyelitis as a complication of the Varicella virus,
not the Varicella vaccine. Neither of these articles conclude that the Varicella vaccination
can cause CRMO, although Petitioner argues that “[t]he Varicella vaccination injects the
Varicella bacteria into the body,” and “[l]iterature indicates Varicella can also cause
osteomyelitis.” Therefore, based on the record before both Special Master Hamilton-
Fieldman and Special Master Roth, Petitioner was not denied her opportunity to present
evidence to meet her burden of proof to establish an earlier symptom onset date prior to
January 2013 or to establish a right to compensation under the Vaccine Act. As indicated
35
above, Special Master Roth found in her September 7, 2017 Decision Denying
Entitlement that:
Petitioner failed to provide an expert report to support her claim that the
vaccinations A.C. received in August 2012 caused his injuries. Additionally,
none of A.C.’s treating physicians related the CRMO to any of the
vaccinations he received. Petitioner has not provided any expert opinion
showing that any of the vaccinations A.C. received can cause CRMO, that
the vaccinations did cause CRMO in this case, or that a five-month onset of
CRMO falls within a medically-acceptable timeframe following the allegedly
causal vaccinations. In light of petitioner’s failure to provide any expert or
medical evidence to support her claim, she cannot sustain her burden of
proof on any of the Althen prongs.
Caron v. Sec’y of Health & Human Servs., 2017 WL 4349189, at *10 (footnote omitted).
Based on a review of the record, the court finds that Special Master Roth’s decision
to dismiss the petition was not arbitrary, capricious, an abuse of discretion or contrary to
law. As noted earlier, even Petitioner in her Motion For Review to this court stated that
she has not presented evidence to meet her burden to prove causation. With regard to
the Althen prongs, discussed above, under the first prong of Althen, Petitioner presents
no expert testimony to establish a “medical theory causally connecting” the alleged
injurious vaccinations to A.C.’s CRMO. The two articles she submitted, as described
above, do not even allege that the Varicella vaccination can cause CRMO, and, therefore,
do not establish a medical theory causally connecting the vaccination and the injury. See
Simanski v. Sec’y of Health & Human Servs., 671 F.3d at 1384 (“[A] finding of causation
must be supported by a sound and reliable medical or scientific explanation, . . . .”)
(internal citations omitted).
With regard to the second Althen prong requiring a logical sequence of cause and
effect, a petitioner must show “that the vaccine was not only a but-for cause of the injury
but also a substantial factor in bringing about the injury.” Althen v. Sec’y of Health &
Human Servs., 418 F.3d at 1278. Again, Petitioner has not submitted evidence
demonstrating that the alleged injurious vaccinations were a substantial factor in causing
A.C.’s CRMO. Petitioner does state in her Motion For Review that A.C.’s rheumatologist
reported in April 2013 that A.C. had suffered no obvious injury or illness that would have
explained his injury. “[A] simplistic elimination of other potential causes of the injury,”
however, does not suffice, “without more, to meet the burden of showing actual
causation.” Id. Petitioner, therefore, has not proven a logical sequence of cause and effect
between the alleged injurious vaccinations and A.C.’s CRMO.
As for the last Althen prong, which requires a proximate temporal link, Petitioner
must offer “preponderant proof that the onset of symptoms occurred within a timeframe
for which, given the medical understanding of the disorder’s etiology, it is medically
acceptable to infer causation-in-fact.” de Bazan v. Sec’y of Health & Human Servs., 539
F.3d at 1352. Petitioner has not submitted any expert opinion or medical literature stating
36
that the five months between the administration of the alleged causal vaccinations and
A.C.’s January 2013 onset constitute proximate timing. Notably, Petitioner admits that
she was unable to find an expert willing to opine on such relationship of causation “that
long after the vaccinations.” Based upon the record before this court, the court finds that
Petitioner has not proven proximate timing between A.C.’s alleged injurious vaccinations
received on August 2, 2012 and A.C.’s January 2013 onset of symptoms. Because
Petitioner has presented no evidence establishing causation under Althen, and because
“[t]he special master or court may not make such a finding based on the claims of a
petitioner alone,” the Special Master’s Decision Denying Entitlement was not arbitrary,
capricious, an abuse of discretion or contrary to law. See 42 U.S.C. § 300aa-13(a)(1).
This court, therefore, denies Petitioner’s requests to overturn Special Master Roth’s
December 14, 2016 Ruling On Onset and her September 7, 2017 Decision Denying
Entitlement. The court also denies Petitioner’s request to remand the case to the Special
Master to allow Petitioner to further pursue obtaining an expert opinion and have another
evidentiary hearing to establish entitlement to compensation.
CONCLUSION
Upon review of the record before this court, including the testimony taken at the
July 11, 2016 fact hearing before Special Master Roth, the medical records, affidavits,
and reconstructed date book, the court AFFIRMS Special Master Roth’s finding of a
January 2013 onset and her decision denying compensation to Petitioner on behalf of
A.C.
IT IS SO ORDERED.
s/Marian Blank Horn
MARIAN BLANK HORN
Judge
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