Court Opinion

ID: 4585647
Source: CourtListenerOpinion
Date Created: 2020-11-12 18:02:18.263106+00
Date Added: 2024-06-11T13:45:36.997252
License: Public Domain

In the United States Court of Federal Claims
                                No. 14-560V
              (Originally filed under seal: October 13, 2020)
                     (Re-filed: November 12, 2020) 1

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

JEAN YATES Individually and as
representative of the late ROBERT YATES,

                                                      National Childhood
                    Petitioner,                       Vaccine Injury Act, 42
                                                      U.S.C. §§300aa-1 to -34
v.                                                    (2012); Motion for
                                                      review; Meningococcal
SECRETARY OF HEALTH                                   conjugate (“Menactra”)
AND HUMAN SERVICES,                                   vaccine; Off-table claim;
                                                      Causation.
                    Respondent.

**************************
    Patricia Finn, Piermont, NY, for petitioner.

       Voris E. Johnson, Senior Trial Attorney in the Torts Branch of the
Civil Division, Department of Justice, Washington, DC, with whom were
Joseph H. Hunt, Assistant Attorney General, trC. Salvatore D’Alessio,
Acting Director, Catharine E. Reeves, Deputy Director, and Alexis B.
Babcock, Assistant Director, for respondent.

                                  OPINION

BRUGGINK, Judge.
      This is a case brought under the National Childhood Vaccine Injury
Act for compensation for injuries allegedly sustained after Robert Joseph

1
  This opinion was held for fourteen days during which the parties were
permitted to propose to chambers any appropriate redactions. The parties
did not propose any redactions and thus we re-issue the decision without
redactions. Rules of the United States Court of Federal Claims, App. B,
Rule 18(b) (“Vaccine Rules”).
Yates received the meningococcal conjugate (“Menactra”) vaccine on July
27, 2012. Robert’s mother, Jean Yates (“petitioner”) filed a petition on
behalf of her deceased son on June 30, 2014, alleging that the administration
of the Menactra vaccine by Mount Kisco Medical Group caused Robert’s
death.

       Pending is petitioner’s motion for review of the Special Master’s
decision of April 16, 2020, denying compensation. Yates v. Sec’y of Health
& Human Servs., No. 14-560V, 2020 WL 2313691 (Fed. Cl. Spec. Mstr. Apr.
16, 2020). The motion is fully briefed, and the court finds that oral argument
is unnecessary. Because the Special Master was not arbitrary or capricious
and did not abuse her discretion in determining that petitioner had not
demonstrated that the Menactra vaccine caused her son’s death, we deny the
motion for review.

                             BACKGROUND

I. Factual History

       The factual history of petitioner’s claim is not in dispute. 2 And
although we summarize the facts and procedural history here, we adopt in
full the excellent presentation by the Special Master in this difficult and
complex case. Robert Joseph Yates was born on January 9, 1994. Pet.’s Ex.
1 at 9 (ECF No. 6-1) (Medical Records of Robert Yates). Robert had a
history of autism and epilepsy but was otherwise healthy. Id. at 15. Robert
attended a special needs program, and liked computers, trains, and
magazines. Id. In 2011, Robert was treated for seizures, a fever, hematuria, 3
an upper respiratory infection, a contusion on his right foot, and possible
strep throat. Id. at 9-32. On July 20, 2011, during Robert’s 17-year-old

2
  Petitioner adopted the Special Master’s factual record set forth in the
Special Master’s decision, and concurs it is consistent with the
contemporaneous medical records proffered, and allegations in the petition.
Pet.’s Mot. for Review at 3, 5 (ECF No. 98).
3
   Hematuria is blood in the urine. On September 23, 2011 Robert was
examined because a few drops of blood were noticed in Robert’s urine. On
physical exam, Dr. Barsh noted Robert appeared healthy, showed no signs of
illness, fever, and Robert was not indicating any pain, nor did he have signs
of a renal stone. Pet.’s Ex. 1 at 28.

                                      2
checkup, Robert’s cardiac exam revealed “regular rate and rhythm without
murmur, rub or gallop.” Id. at 25. Dr. Elliot Barsh described Robert as a
“well-developed, well-nourished boy, in no acute distress,” and that Robert
was a “healthy 17-year old young man with autistic spectrum disorder.” Id.

       The following year, Robert was treated for a persistent cough and
earache, dermatitis and seizures, a deficiency in vitamin D, and possible
pneumonia. Id. at 34-35, 37, 39. Early in 2012, on February 22nd, Robert
had a neurologic appointment with Dr. Tania-Marie Sweeney who reviewed
Robert’s medications. Id. at 41. Robert was taking 2500mg of Keppra in the
morning, and 3000mg of Keppra in the afternoon to control seizures. His
parents had also added another pill of Keppra to Robert’s evening dose
following a recent seizure. Id.

       Mr. Yates explained to Dr. Sweeney that usually he and Ms. Yates,
could avoid taking Robert to the emergency room (“ER”) for seizures, but,
on February 9, 2012, Robert had a seizure on the school bus, and so an
ambulance was called. Id. at 40-41. After arriving at the emergency room,
Mr. Yates recommended to the medical personnel that they give Robert
clonazepam, which they did. Id. Robert was not given Keppra even though
he was due to receive a dose. Id. On the way home from the ER, Robert had
another seizure; so Mr. Yates gave Robert another 2mg of clonazepam and
Robert seemed fine. Id. Robert saw his pediatrician the next day because
the ER doctor said Robert may have pneumonia. Id. The pediatrician ruled
out pneumonia after she examined Robert. Id. Robert’s February 22, 2020
examination concluded with Dr. Sweeney reviewing Robert’s medications
with his parents and outlining a plan to continue his current medications,
which involved Robert taking 1mg of clonazepam at night, 10 mg of Valium
in the morning and evening, and vitamin D weekly. Id. Dr. Sweeney also
indicated she did not want to increase Robert’s Keppra since his dosage was
already high but instead wanted to conduct follow up appointments with
Robert at least every six months. Id.

       Due to continued seizure episodes, a neurologist, Dr. Alexandra E.
McBride examined Robert on May 15, 2012. Id. at 47. At that time, Robert’s
medications included Keppra, Valium, and Clonazepam. The report noted
that Robert had “no medication allergies.” Id. Records from that examination
described Robert’s overall health as “No headaches. No visual complaints.
No gait disturbance. No cardiac, pulmonary, GI, GU, dermatologic,
hematologic, endocrine complaints.” Id.

                                     3
       On July 27, 2012, Dr. Barsh examined Robert again for his 18-year-
old physical. Pet.’s Ex. 1 at 54. Robert’s medications at that time included
Valium, Keppra, Depakote, and Klonopin. Id. Robert weighed 213.5 pounds,
measured 68 inches tall, his blood pressure was 130/80, and his pulse was
80. Id. Dr. Barsh noted that Robert was a healthy 18-year-old with pervasive
delays and epilepsy but “doing much better on his medications at this time.”
Id. Robert’s cardiac exam revealed a “regular rate and rhythm without
murmur, rub or gallop.” Id. The report also mentioned that Robert attended
the special education program at Fox Lane High School, worked on the
computer, had decent sleep, and regular meals. Id. Mr. Yates was asked to
talk with Robert’s school about incorporating an hour of physical activity
into Robert’s daily routine. Id.

       During the exam, blood work was ordered and a sample taken. One
of the panels performed was as Complete Blood Count (“CBC”), which
produces total cell counts in the blood sample, such as red blood cells and
white blood cells. As will become apparent later, the relevant marker
examined was Robert’s eosinophil count, a type of white blood cell, which
came back as a “9.4 %.” Id. at 65.

        At that time, Dr. Barsh discussed the benefits, risks, and possible side
effects of the Menactra vaccine with Mr. Yates. Menactra is administered to
immunize recipients against invasive meningococcal disease, and the vaccine
is approved for administration from 9 months through 55 years of age. Pet.’s
Ex. 26 at 1 (Vaccine manufacturer’s package insert). Dr. Barsh provided
Mr. Yates with a CDC vaccine information sheet that described
meningococcal disease as a serious bacterial illness. Pet.’s Ex. 15 at 1.
Robert’s father gave permission to Dr. Barsh to administer the Menactra
vaccine to Robert, and Dr. Barsh did so. Pet.’s Ex. 1 at 54 (medical records).
The shot Robert received on July 27, 2012 was his second Menactra
vaccination. Robert received his first Menactra shot on August 25, 2005. Id.
at 67. Ms. Yates said she didn’t recall Robert having any problems in 2005
after his first Menactra vaccination. Tr. at 14 (Entitlement Hearing, July 27,
2017) (ECF No. 54).

       Three days later, on July 30, 2012, at about 2:30 p.m., Ms. Yates
checked on Robert in his room, where he was sitting at his desk playing on
the computer. Pet.’s Ex. 22 at 1. At 3:48 p.m., Ms. Yates checked on Robert
again and found him “slumped down in the chair at his desk and did not
appear to be breathing.” His parents started cardiopulmonary resuscitation
(“CPR”), and they called emergency services. Id.
                                       4
        Officer Andrew Thierstein responded to the 911 call. Pet.’s Ex. 22 at
1 (police report). Officer Thierstein followed Robert’s brother to a bedroom
where he observed Mr. and Ms. Yates providing CPR to their son Robert.
Id. Robert was unresponsive, and did not appear to be breathing, but he had
a faint pulse. Id. Officer Thierstein instructed Mr. and Ms. Yates to stop
providing breaths so he could use the bag valve mask (“BMV”), but Mr.
Yates refused. 4 Pet.’s Ex. 22. Ms. Yates stated that the only way they were
going to save Robert was for his father to continue giving breaths while Ms.
Yates continued chest compressions. Id. Ms. Yates stated that “this has
happened before and that they have saved their son in the past by doing what
they are doing.” Id. Mr. Yates stopped CPR a few times, and Officer
Thierstein tried to use the BVM. When Officer Thierstein tried to use the
BVM, Ms. Yates said that the BVM was not working and that Mr. Yates was
very good at giving breaths and that he should continue CPR. Id. When Ms.
Yates tired of giving chest compressions, Officer Thierstein took over CPR
and provided CPR for about a minute until the emergency medical
technicians arrived. Id. When Officer Thierstein spoke to Ms. Yates she
explained that Robert is Autistic and suffers from seizures and that “this was
not the first time something like this has happened, but it was the most serious
occasion to date.” 5 Id.

       Paramedic Walter Hughes took over care after arriving, providing
compressions while Mr. Yates continued giving breaths. Id. Paramedic
Hughes suctioned Robert two times, and attempted to use the BVM, but Ms.
Yates told him that her husband could do a better job, so Paramedic Hughes
stopped using the BVM, and Mr. Yates continued giving breaths. Id. The
ambulance arrived at the Yates’ residence at 3:57 p.m., and Robert was
transported to the emergency room at Northern Westchester Hospital. On
the way to the ER, epinephrine and sodium bicarbonate were administered to
Robert, and the paramedics continued CPR.

4
  A bag valve mask is a breathing device that fits over the patient’s mouth
and provides a seal. Pressurized oxygen connects to the device, and the
medical provider forces oxygen into the patient’s lungs by squeezing a self-
inflating bag.
5
  On December 1, 2017, petitioner filed an affidavit of Jean Yates which
stated that “[t]here was never an occasion that Mr. Yates and I had to do CPR
on Robert or that we called 911 or that Robert was taken to the hospital for a
similar episode until July 30, 2012.” ECF No. 63

                                       5
       Upon arrival at Northern Westchester Hospital at 4:38 p.m., Robert
was diagnosed as being in cardiac arrest and was intubated. Pet.’s Ex. 2 at
7-9 (hospital records). Extensive resuscitation efforts were made, but to no
avail. Id. At 4:57 p.m. treating physicians declared Robert dead. Id. at 8.

       Westchester County Medical Examiner, Dr. Aleksander Milovanovic,
M.D., performed an autopsy on July 31. 2020. Pet.’s Ex. 4 at 10 (Autopsy
Report). Dr. Milovanovic’s autopsy report detailed that Robert was found
unresponsive in his home and that he had pervasive developmental disorder
and generalized seizures. Id. at 13. The report also documented that Robert
was given dissolvable clonazepam on July 30, 2012, and that he received a
second Menactra vaccine on July 27, 2012. Id. Robert’s heart showed mild
hypertrophy of the left ventricle and mild dilation of the right ventricle. Id.
Tissues samples from Robert’s heart were taken from the left ventricle,
septum, and anterior, lateral, and posterior walls. The neuropathology
examination of those tissues revealed subepicardial myocarditis
(inflammation) and the presence of lymphocytic inflammatory infiltrate with
focal myocyte necrosis (cell death). Id. at 14. Consistent with those findings,
the examiner also found “interstitial fibrosis” (lesions) with “scant
lymphocytes.” 6 Id. Dr. Milovanovic thus determined the cause of death to
be lymphocytic myocarditis. Id. at 10.

II. Procedural History

       On June 30, 2014, petitioner timely filed a petition for compensation
under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.
§§300aa-1 to -34 (2012) (“Vaccine Act”). Petitioner also filed relevant
medical records. Pet.’s Ex.1-3 (ECF No. 6); Pet.’s Ex. 4-5 (ECF No. 10).
Petitioner alleged Robert Yates’ death was caused by the administration of
the meningococcal vaccination (Menactra) administered by Mount Kisco
Medical Group on July 27, 2012.

       Respondent subsequently filed a report, recommending against
compensation. Respondent argued that petitioner failed to provide a medical
theory that connected Robert’s Menactra vaccination to his cause of death,
lymphocytic myocarditis, and thus failed to provide a reliable theory of
causation to satisfy the causation standard of Althen v. Sec’y of Health &

6
  A toxicology screen was also performed as part of the autopsy. That test
revealed the presence of anti-seizure medications. No other blood tests were
performed.
                                      6
Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Resp’t Rpt. at 5.
Respondent further contended that petitioner had not established a logical
sequence of cause and effect associating the Menactra vaccine with Robert’s
lymphocytic myocarditis “and/or death,” and that petitioner had failed to
establish an appropriate temporal association between Robert receiving the
Menactra vaccine and the injury. Id.

       On March 24, 2015, petitioner filed a status report detailing the
medical records which indicated Robert received his first Menactra vaccine
on August 25, 2005, and a second Menactra vaccine on July 27, 2012. Pet.’s
Ex. 1 at 67 (ECF No. 19). Petitioner also submitted an expert report from
pediatric cardiologist Dr. Anthony Chang, M.D. (ECF No. 20), and
supplemental medical literature in support of Dr. Chang’s expert report. ECF
No. 21. On November 13, 2015, respondent filed the expert reports and
curriculum vitae of pediatric cardiologist Scott B. Yeager, M.D., and
pathologist Rebecca D. Folkerth, M.D. (ECF No.33). Petitioner filed Dr.
Chang’s reply expert report and supplemental expert report and curriculum
vitae of pathologist Dr. Laurel Waters, M.D. on April 20, 2016. ECF No. 38.

        The Special Master held an entitlement hearing on July 27, 2017, at
which she heard testimony from the petitioner, Robert’s mother, Jean Yates,
and from petitioner’s experts Dr. Laurel Waters and Dr. Anthony Chang.
Respondent’s two experts, Drs. Rebecca Folkerth and Scott Yeager, also
testified at the hearing. After extensive post-trial proceedings, including the
submittal of additional medical literature and briefing, the Special Master
issued her decision on April 16, 2020, denying compensation.

       III. The Expert Opinions

        The Special Master’s decision dealt largely with the parties’
competing expert presentations. Petitioner’s experts, Dr. Chang and Dr.
Waters, offered two theories regarding Robert’s death. According to Dr.
Chang, Robert’s death was due to acute hypersensitivity myocarditis, an
inflammatory condition of the heart muscle, caused by the Menactra vaccine.
Pet.’s Ex. 6 at 2 (Dr. Chang’s Expert Report). Dr. Chang’s reply report notes
that the presence of an elevated eosinophil count (9.4%) from Robert’s July
27, 2012 blood test indicated “most likely a hypersensitivity inflammatory
process that is generalized.” Pet.’s Ex. 11 at 4. Put another way, Robert
suffered a generalized inflammatory response to the Menactra vaccine that
caused heart failure, according to Dr. Chang.

                                      7
       It was not troubling to Dr. Chang that the autopsy examination of
Robert’s heart tissue did not reveal the presence of eosinophils. He submitted
that the generalized inflammatory reaction in the heart “as a result of the
vaccination [could] lead to an eosinophilic and/or lymphocytic myocarditis
as both indicate an inflammatory process.” Id. In sum, he relied on the
presence of elevated levels of eosinophils in Robert’s blood on the day of the
vaccine to conclude that he had suffered a hypersensitive reaction to that
vaccine. In Dr. Chang’s view, that reaction caused a severe myocarditis.

        In response to respondent’s experts, Dr. Chang’s reply report
explained that, in his view, the etiology must be founded on the patient’s
history and other types of evidence, like a viral panel and white blood cell
counts versus the “etiology of the inflammation on the cell subtypes of the
inflammation.” 7 Id. Dr. Chang’s clinical view was that Robert was “totally
healthy without any cardiac or respiratory symptoms and signs upon his visit
with the pediatrician and prior to his vaccination.” Id. His sudden demise,
due to heart failure three days later was the result of an “obvious
hypersensitivity response to the vaccine in the form of an inflammatory
process of the heart that lead to a lethal myocarditis.” Id. Although he noted
the possibility of such a response to a viral infection, he found that case to be
“far less likely” in Robert’s case due to the vaccine. Id. He noted that Dr.
Waters, a pathologist, had found “no laboratory evidence (including viral
panel) supportive of a viral infection.” Id.

        Petitioner’s other expert, Dr. Waters provided an alternative
explanation for Robert’s death, also attributable to the Menactra vaccine.
She opined that the vaccine caused lymphocytic myocarditis. Pet.’s Ex. 13
at 8. In contrast to Dr. Chang, she distinguished between eosinophilic
(hypersensitivity) myocarditis and lymphocytic myocarditis. Dr. Waters
noted from the autopsy results that, “microscopically, there was a
significantly sized focus of inflammation in the heart which was primarily
mononuclear with lymphocytes and macrophages.” Id. at 4. This was
significant to Dr. Waters because, as her report explains, the Menactra
vaccine is T-lymphocyte mediated, which means that the immune system
responds to the vaccine by generating T-lymphocytes to create immunity. Id.
at 5-6. Robert’s immune system was primed to deliver these cells due to his

7
 Dr. Chang cited Robert’s blood work (CBC) on the day of the vaccine,
noting a normal white blood cell count of 7.6 K/uLs, which is indicative, to
Dr. Chang of the lack of a viral infection.

                                       8
first dose of Menactra several years earlier. From these two facts, Dr. Waters
drew the conclusion that “the causation of lymphocytic myocarditis by the
meningococcal vaccine [was] lymphocytes [that] gravitated to the heart’s
conduction system causing a lethal arrhythmia and sudden death.” Id. at 6-
7. She drew further support for this contention from two known cases of
“myocarditis associated with meningococcal vaccine and hepatitis B
vaccine.” Id. at 6. (citing the Barton study which will be discussed below).
Dr. Waters testified at the entitlement hearing that 50% of myocarditis cases
are not caused by viruses and that she believed Robert’s case was one that
was not caused by viruses, but was instead caused by Robert’s immune
system generating T-lymphocytes in response to the Menactra vaccine. Tr.
at 87 (July 27, 2017).

       Dr. Water’s report also mentions a virology screen done as part of the
autopsy bloodwork. Her report states that it was negative for a viral
infection. This was cited in the report’s conclusion section as support for the
idea that the lymphocytic response was from the vaccine rather than a virus. 8
Pet.’s Ex. 13 at 7.

        Respondent’s experts, Dr. Yeager and Dr. Folkerth, offered a more
unified approach, both agreeing that Robert’s immune response to a virus
caused the myocarditis. In his initial report, Dr. Yeager began with Robert’s
autopsy findings from the heart tissue. Dr. Yeager centered on the fact that
lymphocytic inflammatory infiltrate with focal myocyte necrosis was present
in Robert’s heart tissue biopsy, not eosinophils. Resp’t Ex. A at 2. His report
went on to explain the autopsy results and describe the differences between
lymphocytic and eosinophilic myocarditis: according to medical literature,
lymphocytic myocarditis is generally associated with viral infections, and
eosinophilic myocarditis, or hypersensitivity myocarditis, is sometimes
associated with vaccines. Id. at 3 (citations omitted). In Dr. Yeager’s
supplemental report, submitted in response to Drs. Chang and Waters, he
emphatically stated that “the cause of the myocarditis was almost certainly
viral, and the preceding meningococcal vaccination was entirely unrelated to
the subsequent events.” Resp’t Ex. E at 3. The key fact is the lack of
eosinophils in Robert’s heart tissue.
        Dr. Yeager noted that, to date, only two cases are reported in the
literature of myocarditis occurring after a meningococcal vaccination.
Resp’t Ex. A at 3. One case occurred two days after three vaccines were

8
  Dr. Water’s report also noted the lack of other indications of a recent viral
infection in Robert’s medical history.
                                       9
administration, one of which was a meningococcal conjugate, and the
diagnosis was based on clinical, laboratory and imaging findings. Id.
(citations omitted). In the second case of vaccine-caused myocardits, a
bioposy after the vaccine demonstrated eosinophilic infiltration with areas of
eosinophilic degranulation along with immune complexes, complement and
fibrin deposition.” Id. (citations omitted). His report further notes that the
bulk of the known vaccine-induced myocarditis cases are after smallpox
vaccines. Id. (citations omitted). Dr. Yeager concluded that eosinophilic
infiltration would be required for a diagnosis of hypersensitivity or drug
related myocarditis, which was not observed in Robert’s case. Id. at 4. In
other words, eosinophilic myocarditis was incompatible with the evidence
found in Robert’s heart tissue, but a diagnosis of lymphocytic myocarditis
was consistent with Robert’s heart biopsy results.

       In his supplemental report, Dr. Yeager also addressed Robert’s
bloodwork on the day of the vaccine administration. He explained that,
because Robert’s blood specimen was collected on the same day as the
vaccination, the peripheral eosinophilia of 9.4% in Robert’s clinical record
cannot be definitively ascribed to the Menatra vaccine. Resp’t Ex. E at 2.
Dr. Yeager also notes that the high eosinophil levels in Robert’s blood may
have been related to the anti-convulsant medications Robert was taking, since
anti-seizure drugs are common causes of peripheral eosinophilia. 9 Id.

        Dr. Folkerth likewise concluded that Robert’s death was due to
lymphocytic myocarditis, unrelated to the Menactra vaccine. Dr. Folkerth
testified that she relied on the histology reflected in Robert’s autopsy. Tr at
96-97 (July 27, 2017). Dr. Folkerth stated that the pattern of inflammation
in Robert’s heart and the lymphocytes that were present were evidence of
viral myocarditis. Id. at 108-109. She also noted that the heart tissue showed
inflammation in the epicardial fat, and in Dr. Folkerth’s opinion, that was an
indicator of the severity of the inflammation in Robert’s heart. Id. at 139-
140. In her report, Dr. Folkerth also noted that lymphocytic myocarditis is
caused, in most cases, by a viral infection. Resp’t Ex. C at 5. In cases of
viral myocarditis, Dr. Folkerth also explained that it is not uncommon for the
patient to be asymptomatic, as Robert was before his death. Tr. at 12.
        In Robert’s case, both petitioner’s and respondent’s experts agreed
that Robert’s heart tissue extraction, or endomyocardial biopsy, conducted
during the autopsy showed lymphocytic infiltrate. Yates, 2020 WL 2313691

9
 Dr. Yeager also referenced an earlier January 2012 blood test in which
Robert’s eosinophil level was reported to be 6%.
                                     10
at *35. Endomyocardial biopsy, taking tissue samples of the heart, is
considered the “gold standard” for diagnosing myocarditis, and determining
the type of myocarditis. Id. at *35. Respondent’s experts also agreed that
there was no histopathological evidence of eosinophilic infiltrate in Robert’s
heart tissue, but instead showed lymphocytic infiltrate. Id.

       Drs. Yeager, and Folkerth, as well as petitioner’s expert, Dr. Waters,
agreed that the absence of eosinophils in the biopsy precluded a diagnosis of
eosinophilic myocarditis. Id. In contrast, Dr. Chang opined that the absence
of eosinophils in Robert’s myocardial tissue specimen did not preclude the
diagnosis of “a relatively acute inflammatory process in the myocardium as
a direct result of the vaccination.” Pet.’s Ex. 11 at 4.

        Another point of contention for the parties’ experts centered on
whether any testing had been completed to determine if Robert suffered from
a virus at the time of death. One method of making that determination is
through a viral panel assay. During the entitlement hearing, Dr. Folkerth
admitted that she mistakenly believed that a virus panel assay test had been
performed during Robert’s autopsy. Yates, 2020 WL 2313691 at *3. After
confirmation from the examiner’s office by petitioner’s counsel, it was
determined that none had been performed. Id. Dr. Waters, one of plaintiff’s
experts, had used Dr. Folkerth’s report of that viral assay in writing her own
report. Id. Petitioner moved to have Dr. Folkerth’s report and testimony
barred, and respondent offered to have any reference to the assay excluded.
Id. The Special Master sought to have the tests performed after the hearing.
Unfortunately, Luminex testing was not possible because the tissue slides
that would be required were destroyed six months after Robert’s death. Id.
The Special Master thus advised the parites that the mistaken information
would be ignored and that neither party would get the “benefit or detriment”
of the absence of Luminex Virus Panel Assay testing. Id.

IV. The Special Master’s Decision

        On April 16, 2020, the Special Master held that the petitioner failed
to put forth a prima facie case of causation, and that the evidence submitted
established that Robert’s cause of death was lymphocytic myocarditis which
is “most commonly caused by viral infection,” i.e., not by the vaccination.
Id. at *39-40. Because Robert’s heart tissue showed only lymphocytic
infiltrate, the Special Master determined that Robert suffered from
lymphocytic, not eosinophilic, myocarditis. Id. The Special Master found

                                     11
petitioner’s theory implausible because it did not adequately address
Robert’s cause of death, lymphocytic myocarditis

        The Special Master found that petitioner failed to offer a reputable
medical theory that the Menactra vaccine can cause lymphocytic
myocarditis. Id. at *36. The Special Master based this conclusion on two
factors. First, petitioner’s expert, Dr. Waters could not explain how the
Menactra vaccine could cause lymphocytic myocarditis, nor could Dr.
Waters identify any literature that showed an association between vaccines
and the lymphocytic myocarditis found during Robert’s autopsy. Id. at *37.
Second, neither Dr. Waters nor Dr. Chang explained how the Menactra
vaccine caused a hypersensitivity reaction resulting in lymphocytic
myocarditis and cardiac death. Id. Dr. Waters opined that the Menactra
vaccine can cause an anamnestic T-lymphocyte cell response to Menactra,
which in turn causes inflammation resulting in a hypersensitivity response.
Id. Dr. Waters admitted, however, that hypersensitivity myocarditis is
eosinophilic by definition. Id. Respondent’s expert, Dr. Yeager, responded
that Dr. Waters’ theory that “the Menactra vaccine produced T-lymphocytes
that gravitate to the cardiac conduction system causing lymphocytic
myocarditis cannot be found anywhere in the available medical literature.”
Id. at *38. The Special Master agreed with Dr. Yeager.

       Dr. Chang opined that hypersensitivity myocarditis could be
characterized by either eosinophils or lymphocytes. Id. at *38. He testified
that whether a patient had lymphocytic myocarditis or eosinophilic
myocarditis was of no concern to him because his focus was on clinical
symptoms and treating the patient. Id. Dr. Yeager again responded that this
opinion was unsupported by the medical literature because a hypersensitivity
reaction is indicated by the presence of eosinophils. Id. The Special Master
agreed.

       Although petitioner’s experts opined that Robert suffered a
hypersensitivity reaction to Menactra, regardless of Robert’s specific
diagnosis of lymphocytic myocarditis, the Special Master found this opinion
unsupported. Id. at *38. Dr. Waters testified that “hypersensitivity
myocarditis” is a clinical term and “lymphocytic myocarditis” is a
histological term. Id. She continued: “a clinical diagnosis of hypersensitivity
myocarditis could have a predominantly lymphocytic infiltrate.” Id. She
submitted that Robert had a Type IV delayed hypersensitivity reaction,
stating that Type IV reactions have a wide range of symptoms. Id. The
Special Master observed that Dr. Waters did not submit literature connecting
                                      12
Type IV hypersensitivity reactions with lymphocytic myocarditis nor a Type
IV hypersensitivity reaction. Id.

       The Special Master also noted that neither Dr. Waters nor Dr. Chang
revealed how Robert could be asymptomatic between July 27, 2012, and July
30, 2012, if in fact the vaccine caused Robert to have a hypersensitivity
reaction, resulting in fulminant myocarditis after the Menactra vaccine. Id. at
*39. Instead, the Special Master observed that petitioner recalled Robert
behaving normally, playing video games, and attending school without issue
in the days following Robert’s Menactra vaccination. Id. Dr. Yeager
asserted that the literature demonstrates that cases of viral myocarditis,
presumably unlike hypersensitivity myocarditis, are commonly
asymptomatic. Id.

       Finally, the Special Master held that petitioner’s experts had not
explained why the three-day interval between Robert’s vaccination and death
was “an appropriate time frame” for a hypersensitivity reaction. Id. at *40.
In contrast, respondent’s expert stated that the inflammatory pattern on
Robert’s autopsy is not consistent with a hypersensitivity reaction,
explaining that Robert’s autopsy showed he had lymphocytes in the
epicardial fat, the outside layer of the heart, which was an indicator that not
only the heart, but the tissue around the heart, was affected. Id. The type of
inflammation exhibited in Robert’s autopsy report concerning his heart
would take “days to weeks to develop.” Id.

       Based on the medical records, medical literature submitted by the
parties, and testimony given, the Special Master determined that
respondent’s experts were more persuasive and their opinions more
consistent with all the literature submitted. Id. at *38. We find no error in
these conclusions, as discussed below.

                               DISCUSSION

        This court has jurisdiction to review the Special Master’s decision in
accordance with 42 U.S.C. § 300aa-12. Our review is deferential, only
setting aside decisions when they are “arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law . . . .” Id. § 300aa-12(e).
When the Special Master has considered the relevant evidence and
articulated a rational basis for the decision, reversible error is “extremely
difficult to demonstrate.” Hines v. Sec’y of Health & Human Servs., 940
F.2d 1518, 1528 (Fed. Cir. 1991). We do “not reweigh the factual evidence,
                                      13
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.”
Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1249 (Fed. Cir.
2011).

        A petitioner may seek compensation for “any illness, disability,
injury, or condition” sustained or significantly aggravated by a vaccine. 42
U.S.C. §§ 300aa-11(c)(1) to 13(a)(1)(A). When a petitioner seeks
compensation for an injury caused by an off-table injury, a vaccine other than
those injuries listed on the Vaccine Injury Table, petitioner must prove
causation in fact. Althen, 418 F.3d at 1278 (citing 42 U.S.C. § 300aa-
13(a)(1)(A)). Petitioner must show that the vaccination caused the injury by
proving three elements by a preponderance of the evidence: “(1) a medical
theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for
the injury; and (3) a showing of a proximate temporal relationship between
vaccination and injury.” Id.

       A different showing corresponds to each of the elements, but the same
evidence may be used to prove more than one element. Id. First, petitioner
must provide a reputable medical theory that demonstrates that the vaccine
can cause the alleged injury. Id. A petitioner is not, however, required to
submit medical literature, propose a generally accepted theory, or
demonstrate proof of scientific certainty. See Andreu v. Sec’y of Health &
Human Servs., 569 F.3d 1367, 1378 (Fed. Cir. 2009). Yet, petitioner cannot
prevail on “a ‘plausible’ or ‘possible’ causal link between the vaccination
and the injury; he must prove his case by a preponderance of the evidence.”
W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir.
2013) (citing Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315,
1332 (Fed. Cir. 2010)). “[A] mere showing of a proximate temporal
relationship between vaccination and injury” is insufficient to prove actual
causation. Althen, 418 F.3d at 1278.

        To demonstrate a logical sequence of cause and effect, petitioner may
use reputable medical or scientific evidence, including medical records. See
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed.
Cir. 2006) (citations omitted). Additionally, the treating physician’s opinion
is entitled to weight, particularly because it was created contemporaneously.
Id. Finally, petitioner must establish that there is a “medically-acceptable”
timeframe between the vaccination and alleged injury that is consistent with
                                     14
the theory of how the vaccine could cause the injury. De Bazan v. Sec’y of
Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).

        The central dispute in this case was whether the myocarditis that lead
to Robert’s heart failure was caused by a virus or a more generalized
hypersensitivity reaction to the vaccine. It was petitioner’s burden to prove
the latter by preponderant evidence. Although petitioner failed to establish
its causation theory and thus respondent had no duty to establish a cause
unrelated to the vaccine, the Special Master was convinced by the
government’s position that a viral cause was more likely than not to blame
for the deadly myocarditis. On review, petitioner makes several objections
to the Special Master’s findings, but her arguments revolve mostly around
the evidence, or lack thereof, of a virus infecting Robert at the time of
vaccination. 10

       Petitioner urges that the medical records from the day Robert was
vaccinated conclusively establish that he did not have a viral infection on that
day. Presumably, petitioner also believes that she has established that Robert
did not have a virus on the day he died either. Petitioner points to the records
from Dr. Barth’s physical examination of Robert on July 27, 2012. In them,
Dr. Barth reports that Robert was, other than recent seizure episodes, healthy.
No cardiac issues or other symptoms associated with a viral infection were
recorded. And, most important to petitioner’s theory, the blood test done that
day showed a normal white blood cell count. Those two facts—chiefly the
latter—are relied on throughout petitioner’s motion. Petitioner argues
repeatedly that the lack of evidence of a virus on the day of vaccination is
incompatible with a conclusion that a virus is to blame for Robert’s death.
The conclusion for Ms. Yates therefore is that the Special Master was
arbitrary when she credited the opinions of respondent’s experts, because
those opinions were based primarily on an assumption that the medical

10
   Petitioner also makes much of the Special Master’s treatment of the lack
of a viral assay. We find no abuse of discretion in the Special Master’s
decision that the lack of such a test would not be held against either party.
That result could not have prejudiced petitioner, whose argument on review
is based primarily on the lack of evidence of a virus. Further, the fact that no
assay was performed did not call into question Dr. Folkerth’s larger opinions
in any way as Dr. Folkerth was operating under the assumption that the assay
provided no evidence of a virus.

                                      15
records do not support. The Special Master’s conclusion therefore is not
borne out by the evidence, according to petitioner.

        The other piece of evidence that petitioner highlights in her motion
for review is a one-page abstract of a study that Dr. Chang submitted after
the hearing: A.P. Burke, et al., Hypersensitivity Myocarditis, 115 Arch.
Pathol. Lab. Med. 764-69 (1991), which was marked as Pet.’s Ex. 24.
Petitioner avers that the authors found that the degree of infiltrate in cardiac
tissue was unrelated to the symptoms of hypersensitivity myocarditis. Pet.’s
Mot. for Review 16. The authors of that study examined tissue samples from
69 cases of hypersensitivity myocarditis. Eosinophils were found in 30 of
those samples and lymphocytes in 12 of them. 11 The conclusion for the
authors was that “cardiac symptoms were not related to the degree of cellular
infiltrate.” Id. (citing Pet.’s Ex. 24). The Special Master recited the same
findings in her decision but added one additional finding noted in the
abstract: The authors defined hypersensitivity myocarditis “by the presence
of eosinophils, a mixed lymphohistiocytic infiltrate along natural planes of
separation, and an absence of fibrosis or granulation tissue in areas of
infiltrate.” 2020 WL 2313691 at *16 (citing Pet.’s Ex. 24). Also relevant
from that abstract was the statement that “infiltrates may be missed by
endomyocardial biopsy due to facility of lesions.” 12 Pet.’s Ex. 24. From
these brief statements, petitioner draws support for her experts’ opinion that
a reaction to a vaccine might also cause lymphocytes to be present in the

11
   We note that, at least as to the eosinophils, these findings appear to be from
liver tissue samples, not cardiac tissue.
12
   Petitioner’s motion also cites one of the studies submitted by Dr. Yeager
regarding reactions to the smallpox vaccine: Dimitri C. Cassimatis et al.,
Smallpox Vaccination and Myopericarditis: A Clinical Review, 43 J. Am.
Coll. Cardiol. 1503-10 (2004), marked as Resp’t Ex. A-8 (attached to Dr.
Yeager’s report). Petitioner quotes a statement therein: “in more than half
the cases, infiltrates may be missed by endomyocardial biopsy due to focality
of lesions.” We were unable to locate this statement in that study. We note,
however, that this study, like the Burke study above, found a mixed infiltrate
of lymphocytic infiltrate with eosinophil degranulation in areas of
myocardial necrosis. “These findings support a non-infectious pathogenesis
of inflammation, similar to hypersensitivity myocarditis.” Cassimiatis at
1509. Of note, however, is that even in such instances, the presence of
eosinophils was noted.

                                       16
cardiac tissue and that the posthumous biopsy might have inadvertently
missed the presence of eosinophils.

       Petitioner wraps up her motion by concluding that she proved that it
was more likely than not that Robert “died from a type of myocarditis that
was non-viral, i.e., an acute hypersensitivity reaction to the meningitis
vaccines evidenced by lymphocytes in the heart tissue samples . . . and
elevated levels of eosinophils in the peripheral blood evidencing the onset of
an allergic reaction.” Pet.’s Mot. for Review 24. Petitioner urges that her
experts had demonstrated “how the lymphoctyes in Robert’s heart had been
induced by an acute allergic hypersensitivity reaction to the [vaccine].” Id.
We disagree.

I. The Finding That The Cause Of Death Was Lymphocytic Myocarditis
Was Not Unreasonable

        We find no error in the Special Master’s conclusion that Robert died
from lymphocytic myocarditis. The medical examiner concluded the same.
Three of the four experts agreed that the absence of eosinophils in Robert’s
cardiac tissue generally precluded a diagnosis of eosinophilic myocarditis.
Dr. Chang alone opined that a hypersensitive reaction to the vaccine might
result in lymphocytic infiltration of the heart. Although the two studies,
Burke and Cassimatis, cited on review, provide some evidence that a mixed
infiltrate of eosinophils and lymphocytes has been noted in cases of
eosinophilic myocarditis, that does not explain away the fact that Robert’s
heart tissue showed only an infiltration of lymphocytes. Further, the Burke
study’s finding that the symptoms of myocarditis did not correlate directly to
the level of tissue infiltration does not provide support for either theory. We
read that only as stating that the level of infiltration of, either or both,
lymphocytes and eosinophils cannot be correlated directly to the severity of
the myocarditis observed. 13

      In theory, the possibility exists that there were eosinophils present in
Robert’s cardiac tissue that went unsampled by the medical examiner. That

13
  We were hampered, as was the Special Master, by the fact that only the
abstract of that study was submitted to the Special Master. The abstract does
not provide the necessary context to read anything further into the statement
that the level of infiltration observed did not correlate with the severity of the
symptoms of hypersensitivity myocarditis suffered.

                                       17
possibility, however, does not cast doubt on the Special Master’s conclusion.
She had only the evidence available and could not rely on the notional
possibility of the existence of evidence unknown and now unknowable. The
uncontroverted fact is that the biopsy revealed only lymphocytes. From that,
respondent’s experts inferred lymphocytic myocarditis. That result is
supported by the literature presented. It was therefore entirely rational for
the Special Master to conclude that such was the cause of death. It is
certainly rational to credit that diagnosis over one that would require the
presence of eosinophils, of which there is no evidence. The only remaining
question is whether petitioner otherwise provided a reliable explanation of
how the vaccine caused lymphocytic myocarditis. That leaves Dr. Water’s
alternative theory.

II. Petitioner Did Not Show How The Vaccine Caused An Infiltration Of
Lymphocytes in Robert’s Heart

        We begin with the lack of evidence of a virus on the day that Robert
was vaccinated. Contrary to petitioner’s argument on review, that absence
does not conclusively establish any fact. The absence of evidence of a thing
is not evidence of its absence. The argument to the contrary is an appeal to
ignorance, a logical fallacy. As the Special Master correctly held, it is
unknown whether Robert was virus free at the time of his Menactra
vaccination. 14 Yates, 2020 WL 2313691 at *36. Based on the evidence from
three days later, however, a different conclusion was reached.

       Respondent’s experts inferred a viral infection as the cause of death
from the presence only of lymphocytes in Robert’s heart tissue on the day he
died. The Special Master found this inference reasonable and relied on it.
Neither Dr. Chang nor Dr. Waters specifically opined that this was fallacious
or otherwise an unreasonable conclusion. Instead, they drew contrary
inferences from the lack of indication of a viral infection three days earlier.
In other words, they assumed away the possibility of a virus, leaving only the
vaccine as the likely casual factor. As between the two inferences, we find,
like the Special Master, the former more reasonable as it is supported by

14
   Petitioner also cites Robert’s white blood cell count from the day of
vaccination, which was within normal range. No expert was asked nor
otherwise opined that this was conclusive evidence that Robert was
uninfected by a virus. This is not to mention the possibility of an infection
in the three days before he died. Additional evidence regarding the meaning
of that blood cell count was not provided.
                                     18
affirmative evidence. That leaves only Dr. Water’s alternative theory that
the vaccine caused the lymphocytic myocarditis.

        Dr. Waters testified and wrote in her report that the vaccine could have
caused lymphocytic myocarditis because the meningococcal vaccine causes
the body to produce T-cells (a type of lymphocyte) to generate the immunity
sought. That may be the case, but, as the Special Master stated, that does not
explain how those cells caused myocarditis. There is also a total lack of
evidence in the literature presented of such a causal connection. The Barton
study cited by petitioner in her motion for review dealt with eosinophilic
myocarditis and is therefore irrelevant to this theory. 15 The Thanjan study
did not involve a biopsy nor a determination of which type of myocarditis
was suffered. 16 The smallpox vaccine case studies submitted likewise
showed only eosinophilic reactions. The Special Master was neither
arbitrary nor capricious in not crediting this theory of causation.

                               CONCLUSION

        The Special Master had a reasonable basis for her conclusions, and
that is all that is required on review to this court under the Vaccine Act. The
evidence pointed away from the causal theories presented by petitioner.
Respondent provided preponderant evidence of a viral infection as the causal
agent. We find no legal error in how the Special Master weighed the
evidence nor in how she applied the Althen factors. Affirmance is thus
appropriate.

       Because the Special Master rationally determined that petitioner did
not demonstrate causation of the injury sustained, and the Special Master did
not otherwise act arbitrarily or in violation of law, we affirm her decision.
Accordingly, we deny petitioner’s motion for review. The clerk is directed
to enter judgment accordingly.

15
  Michelle Barton et al., Eosinophilic Myocarditis Temporally Associated
With Conjugate Meningococcal C and Hepatitis B Vaccines in Children, 27
Pediatr. Infect. Dis. J. 831-35 (2008), marked as Pet.’s Ex. 17.
16
   Maria T. Thanjan et al., Acute Myopericarditis After Multiple Vaccinations
in an Adolescent: Case Report and Review of the Literature, 119 Pediactrics
1400-03 (2007), marked as Pet.’s Ex. 8 and Resp’t Ex. A-11. It was also
attached to Respondent’s Exhibit C.
                                     19
     s/Eric G. Bruggink
     ERIC G. BRUGGINK
     Senior Judge

20