Court Opinion

ID: 4170844
Source: CourtListenerOpinion
Date Created: 2017-05-22 20:05:25.424152+00
Date Added: 2024-06-11T14:24:12.722316
License: Public Domain

In the United States Court of Federal Claims
                                No. 15-972V
                       (Originally filed: May 1, 2017)
                         (Re-filed: May 22, 2017)1
**********************
PAUL MONDELLO,

                     Petitioner,
                                                  National Childhood
v.                                                Vaccine Injury Act;
                                                  Hepatitis A Vaccine;
SECRETARY OF THE                                  Seizure Disorder; Motion
DEPARTMENT OF HEALTH AND                          for Review; Causation.
HUMAN SERVICES,

                 Respondent.
**********************
    Verne E. Paradie, Jr., Lewiston, ME, for petitioner.

       Darryl R. Wishard, Senior Trial Attorney in the Torts Branch of the
Civil Division, Department of Justice, Washington, DC, with whom are,
Benjamin C. Mizer, Assistant Attorney General, C. Salvatore D’Alessio,
Director, Catherine E. Reeves, Deputy 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 the administration of a
hepatitis A vaccination received by petitioner, Paul Mondello, on November

1
  Publication of this opinion was deferred pending the parties’ review for
redaction of protected information. See Rules of the Court of Federal Claims,
App. B, Rule 18(b). Neither party submitted proposed redactions.
Accordingly, the opinion appears below in full.
15, 2013.2 The petition alleges that the vaccine caused him to develop a seizure
disorder and related neurological symptoms and deficits. The Special Master
dismissed the petition for lack of evidence of causation. Petitioner has
appealed that decision in a motion for review to this court. The motion is fully
briefed, and oral argument is deemed unnecessary. Because there was some
evidence evincing a theory of causation, we reverse the Special Master’s
decision and remand for further proceedings consistent with this opinion.

                               BACKGROUND

I. Factual History

        Petitioner was born on October 2, 1943. He served in the Vietnam War
and was honorably discharged after receiving a severe blow to the head and
crush injuries to his knees and back. Afterwards, he was treated at Togus
Veterans Administration Hospital (“Togus”) for hypertension, post-traumatic
stress disorder (“PTSD”), osteoarthritis, hearing loss, gastroesophageal reflux
disorder, migraines, abnormal glucose, chronic back pain, and chronic
hepatitis. Petitioner’s medical history included Agent Orange exposure,
traumatic brain injury, crush injuries to the knees and back, and Stevens-
Johnson syndrome from taking hydrochlorothiazide.

       Petitioner was admitted to a rehabilitation program at Togus for alcohol
and daily cannabis dependence in October 2013. He also regularly used
benzodiazepine to treat panic attacks and anxiety, but reported having
discontinued its use during this time period. He was also prescribed
cyproheptadine, an antihistamine, for his PTSD-related symptoms during this
admission at Togus.3

2
 Petitioner was administered a Twinrix hepatitis A and B vaccination, but
most of petitioner’s records refer only to hepatitis A vaccination as the cause
of his seizure disorder.
3
  Cyproheptadine is an anti-histamine used to relieve allergy symptoms such
as sneezing, itching, watery eyes, runny nose, and other symptoms of allergies.
It is also used to treat nightmares in those suffering from symptoms of PTSD.
Its side affects are reported as including dizziness, blurred vision, fatigue, and
palpitations. Overdosage can result in hallucinations, convulsions, and central
nervous system (“CNS”) depression. It is thought to have additive effects with
                                                                    (continued...)

                                        2
       On November 15, 2013, petitioner visited Togus for a follow up to his
rehabilitation. Records from that visit noted that he reported not having had
alcohol for 36 days and that his medications included cyproheptadine. It was
during this visit when petitioner received a Twinrix hepatitis A and B vaccine.

        A week later, on November 22, 2013, petitioner was admitted to St.
Joseph’s Hospital during an episode of active seizures and an altered state of
consciousness. He was actively seizing upon arrival at the hospital. His wife
reported that he had not been feeling well since receiving the Twinrix
vaccination and that he suffered from nausea, vomiting, and poor appetite. She
also stated that petitioner had taken cyproheptadine for the first time at around
4:00 pm that day because he was experiencing tremors, anxiety, and chest
palpitations. She recalled that he became confused shortly thereafter and began
hallucinating and talking about flashes of light at approximately 5:00 pm,
which was about the time petitioner had the seizures.

        Upon arrival at the hospital, petitioner had a Glasgow Coma Scale
(“CGS”) score of 7; he was intubated and administered diazepam.4 He
underwent a CT scan of his head, which was normal. He tested positive for
benzodiazepines and marijuana. Petitioner was then transferred to the
emergency department at Eastern Main Medical Center (“EMMC”) with an
assessment of “generalized status epilepticus of unknown cause,”and noting
that petitioner was a longstanding alcoholic but had been sober for 46 days,
with no prior history of seizures. Mondello v. Sec’y of HHS, No. 15-972V,
Slip. Op. at 3 n.4. (Fed. Cl. Spec. Mstr. Nov. 15, 2016) (quoting Pet.’s Ex. 1
at 31).

       At EMMC, petitioner underwent a battery of diagnostic tests. An EEG
showed “diffuse right-sided slowing,” “transient periodic right lateralized
discharges involving frontal area,” and “intermittent spikes throughout the
record involving right frontal area.” Id. (quoting Pet.’s Ex. 5 at 1394). An MRI
revealed “no acute or malignant intracranial process,” with “moderate burden

3
    (...continued)
alcohol and other CNS depressants. Mondello v. Sec’y of HHS, No. 15-972V,
Slip. Op. at 3 n.4. (Fed. Cl. Spec. Mstr. Nov. 15, 2016) (unpublished order
dismissing petition).
4
 GCS is used to measure the severity of an acute brain injury, where a score
of 3 is the most severe and a score of 15 is the least severe.

                                       3
of white matter signal changes” and “mild diffuse cerebral volume loss.” Id.
(quoting Pet. Ex. 5 at 1400). Treating physicians were uncertain of the clinical
significance of these results.

       While at EMMC, petitioner was treated by a neurologist, Dr. Bourque.
She ordered a lumbar puncture of Mr. Mondello because of the possibility that
he may have had an aseptic meningitis related to the vaccination. The lab test
was negative for meningitis. Dr. Bourque prescribed Keppra, an anti-seizure
medication, and petitioner was discharged from EMMC on November 27,
2013, with a diagnosis of new-onset seizure, with delirium and hyponatremia.5
The discharge summary reflected no specific cause but noted that his condition
was consistent with alcohol withdrawal and the possibility of benzodiazepine
withdrawal. The summary also reported that the hepatitis A vaccine’s effects,
along with other medications and health problems were all of note as well as
possibly having a causal link.

        Through December 2013, petitioner received physical therapy at home.
On January 9, 2014, he sought care at Mayo Practice Associates (“Mayo”)
after complaining of left trapezius strain and knee pain. The Mayo record listed
cyproheptadine as one of his allergies, with a reaction of seizures and
confusion.

        On January 30, 2014, petitioner met with Dr. Bourque for a follow-up
visit. Her notes from that occasion record that she had initially treated him at
EMMC on November 2013 for a new onset of seizures. Those notes further
reflected that he had been administered a hepatitis A vaccine one week prior
to his hospitalization and that he reported experiencing nausea, vomiting,
headache, and chills during the intervening week. Further stated was that, on
the day of hospitalization, he took four milligrams of cyproheptadine for the
first time in his life. His wife informed doctors that within 20-30 minutes of
taking cyproheptadine, he started experiencing visual hallucinations. She then
left the room to call 911, and when she came back, found him seizing.

       Dr. Bourque’s notes also record that petitioner had not suffered any
further severe headaches, seizures, fevers, or lateral weakness since his
discharge from EEMC, and had done well on Keppra. Overall, his mental

5
 Hyponatremia is a condition when the level of sodium in the blood becomes
abnormally low, which can cause nausea, vomiting, headache, confusion,
fatigue, muscle weakness, and seizures.

                                       4
status had returned close to baseline, although his wife stated that he
occasionally had episodes during which his ability to give directions seemed
impaired. Dr. Bourque suggested that he see a neuropsychologist for a baseline
assessment of cognitive strengths and weaknesses.

       On April 7, 2014, petitioner again saw Dr. Bourque for another follow-
up appointment. Dr. Bourque again recorded petitioner’s history regarding the
administration of the vaccine, subsequent illness, and presentation at the
hospital for seizures a week later. Notes from the April 7 visit indicate that Mr.
Mondello had not experienced any more seizures nor spells of confusion, but
had started drinking again intermittently. These notes also reflect that
petitioner was again tested with an EEG on February 24, 2014, which returned
normal results. During this visit, Dr. Bourque also discussed with petitioner
tapering off Keppra. She warned, however, that there was a potential for
recurrent seizures. She also mentioned the possibility of switching from
Keppra to Trileptal, but Mr. Mondello was not interested in pursuing any of
these options because it would have meant that he would have had to stop
driving for three to six months, and he had been tolerating Keppra better.

        Almost a year later, on March 20, 2015, petitioner was treated by Dr.
Bourque for a possible seizure despite the anticonvulsants after petitioner had,
of his own initiative, reduced his Keppra dosage by a quarter for two days. He
reported returning to the full dose during the weekend prior to this visit, but
that on the following Tuesday he experienced an unusual 30-second episode
of facial distortion and general unresponsiveness without limb shaking,
automatisms, or lip smacking. In her records, Dr. Bourque again noted the
history of hepatitis A vaccine a week prior to the initial 2013 seizures and the
first dose of cyproheptadine shortly before the seizure onset. She advised that
petitioner return to his regular Keppra dosage and that they would discuss
tapering off it again later that fall.

       Petitioner’s next visit to Dr. Bourque was on October 2, 2015. He had
suffered no further seizures after the March 20, 2015 appointment. Dr.
Bourque noted that:

       [p]etitioner continues to have a history of hospitalization with
       what was suspected to be possibly a provoked seizure in 2013,
       but with an abnormal EEG at that time. When he tried taking
       himself off Keppra earlier this year, he had what was an atypical
       spell that may have represented a seizure, so we will continue on

                                        5
       Keppra.

Pet’s Ex. 7 at 1451.

        On March 18, 2016, petitioner returned for his final visit to Dr. Bourque
regarding his seizures. Petitioner reported to Dr. Bourque that, although he had
not experienced any further seizures, he was experiencing some cognitive
difficulties. The doctor’s notes again recited his history beginning with the
2013 hepatitis vaccine and subsequent hospitalization. These notes included
the opinion that the 2013 seizures were the result of a combination of
petitioner’s being unwell from the hepatitis A vaccine and having taken
cyproheptadine. Her diagnosis for petitioner’s cognitive trouble was that it was
likely the result of a combination of his previous head injuries, alcoholism,
chronic pain, and untreated psychiatric illness. Petitioner was discharged from
neurological care on this date.

II. Procedural History

        On September 3, 2015, petitioner timely filed a petition for
compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. §§
300aa-1 to-34 (2012) (“Vaccine Act”). He eventually, after twice
supplementing, filed all of his relevant medical records. Respondent
subsequently filed a report, as required by Vaccine Rule 4(c)(1),
recommending against compensation. Respondent argued that petitioner had
failed to satisfy the causation standard articulated in Althen v. Sec’y of HHS.,
418 F.3d 1274, 1278 (Fed. Cir. 2005), and further avered that “the more likely
cause of petitioner’s seizure onset was the resultant side effect of his first dose
of cyproheptadine.” Resp’t Rule 4(c) Report at 6.

        The Special Master reviewed the petitioner’s records and ordered him
to file an expert report because his records did not provide a medical theory
causally connecting the vaccine at issue with petitioner’s injury. Mondello v.
Sec’y of HHS, No. 15-972V (Fed. Cl. Spec. Mstr. May 19, 2016). Petitioner
instead informed the court that he had filed all of his relevant medical records
and would not be filing an expert report. Then, on August 1, 2016, petitioner
filed a 10-page motion asking for a decision on the merits based on the record
as it was, or, in the alterative, for an evidentiary hearing.

      In his motion for a ruling on the record, petitioner relied most on Dr.
Bourque’s treatment records, arguing that they contained the doctor’s opinion

                                        6
that the vaccination was a substantial factor in bringing about his seizure
disorder. Petitioner acknowledged that he had not submitted an expert opinion
as to “the exact biological mechanism” causing his illness but argued that none
was necessary given the temporal relationship between the onset of symptoms
after the vaccination, medical literature in the record, and Dr. Bourque’s
“opinion that the vaccination was a contributing factor to Mr. Mondello’s
condition.” Pet.’s Mot. for Ruling on the R. 4. He further argued that
requiring proof of a specific biological mechanism was inconsistent with the
purpose of the Act and imposed an impermissibly high evidentiary standard on
claimants.

        After confirming that petitioner understood the ramifications of a ruling
on the record as opposed to a dismissal decision, the Special Master issued a
decision on November 15, 2016, dismissing the petition because petitioner
“failed to produce preponderant evidence that the hepatitis A vaccination [was]
responsible for his condition.” Mondello, Slip. Op. at 9. The Special Master
reviewed Dr. Bourque’s records but disagreed with petitioner as to their
contents. She found that they did not offer any specific causative theory of how
Mr. Mondello’s seizures were caused by the vaccine and that the doctor did
not otherwise opine that the seizure would not have occurred in the absence of
the vaccination. Id. at 8. The Special Master stated that the medical records
were only a detailed recitation of the facts related to petitioner’s hospitalization
and his symptoms since November 2013. She further found that petitioner’s
list of other morbidities, along with his first dose of cyproheptadine,
undermined the allegation that the hepatitis A vaccine was more likely than not
the cause of, or a substantial factor in causing, the seizure disorder. Without
a sufficient medical opinion on causality or other plausible medical theory in
support of his claim, the Special Master held that she was constrained by the
case law to dismiss the petition for lack of evidence of causation. Petitioner
filed a motion for review of this decision on December 14, 2016, and
respondent filed a response to the motion on January 11, 2017.

                                 DISCUSSION

       In his motion for review, petitioner asserts that the Special Master erred
in ignoring the opinion of the treating physician and should not have penalized
petitioner for not hiring an expert to opine on causation. Petitioner argues that
Dr. Bourque’s records contained an opinion that the hepatitis vaccination was
a substantial causative factor in the seizures that he suffered. That Dr. Bourque
did not posit a theory of the precise biological mechanism that caused the

                                         7
vaccine to injure plaintiff is not dispositive, according to petitioner,
particularly given her more general opinion that it was a co-factor in causing
the injury and the medical literature that he argues provides an etiological link
between the vaccine and the seizures suffered.

        By emphasizing the fact that petitioner did not submit an outside expert
opinion and by not taking account of the relevant medical and scientific
literature, the Special Master impermissibly raised petitioner’s burden of
providing a medical theory beyond that of biological plausibility–all that is
required by the Vaccine Act–argues petitioner. As to a temporal link between
the vaccine and the injury, petitioner contends that his medical records show
that he became ill immediately after being vaccinated and that he remained so
until he was hospitalized with the seizures. The cyproheptadine posited as a
cause by the government is a red herring because he was already sick before
taking it; he asserts that he would not have taken it had he not been ill for a
whole week following the vaccination.

        The government responds that the Special Master appropriately
considered all the evidence and followed applicable legal precedent in
determining that petitioner failed to meet his burden of proving causation.
Respondent agrees with the Special Master that Dr. Bourque’s records do not
contain any specific medical theory regarding how the hepatitis A vaccine
could cause the seizures, which is insufficient to meet the standard of proof,
it argues. Respondent also offers petitioner’s other medical and substance
abuse problems as factors undermining his claim that the vaccine was “more
likely than not” the cause of his seizure onset.

        Respondent further contends that petitioner misinterprets the law
regarding the significance of the opinions of treating physicians, especially
when, as in this case, they do not posit an actual theory of biological causality
or unequivocally state that the cause of the injury was the vaccine. Finally, in
response to petitioner’s point that the Special Master ignored his medical
literature aimed at the first prong–a medical theory of causation–the
government argues that the special masters are not required to discuss every
piece of evidence present in the record as long as the decision is clear that they
have considered all of the parties’ evidence and arguments.

I. Jurisdiction And Standard Of Review

       We have jurisdiction pursuant to 42 U.S.C. § 300aa-12 to hear appeals

                                        8
of decisions by the Office of Special Masters granting or denying
compensation. In reviewing a decision rendered by a Special Master, we may:
(1) uphold the findings of fact and conclusions of law; (2) set aside any of the
findings of fact or conclusions of law “found to be arbitrary, capricious, an
abuse of discretion, or otherwise not in accordance with law;” or (3) 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)(A)-(C).

       In deciding a motion for review, we do not “re-weigh the factual
evidence, or . . . assess whether the special master correctly evaluated the
evidence” nor do we “examine the probative value of the evidence or the
credibility of the witnesses. These are all areas within the purview of the fact
finder.” Lampe v. Sec’y of HHS, 219 F.3d 1357, 1360 (Fed. Cir. 2000). This
means that if the Special Master has considered the relevant evidence of the
record, drawn plausible inferences, and articulated a rational basis for the
decision, the court reviewing the Special Master’s decision is compelled to
uphold the findings as neither arbitrary nor capricious. Cedillo v. Sec’y of
HHS, 617 F.3d 1328, 1338 (Fed. Cir. 2010).

        To receive compensation for a vaccine related injury under the Vaccine
Act, the petitioner bears the burden of proving by a preponderance of the
evidence the elements required to entitle him or her to relief, which are listed
in 42 U.S.C. § 300aa-11(c)(1). For an “off table” injury case, as here, the
petitioner has the burden to prove that the vaccine “caused” the illness,
disability, injury, or condition. Id. § 300aa-11(c)(1)(C)(ii)(I). This mean that
a petitioner must show by preponderant evidence both that the vaccination was
a “substantial factor” in causing the illness, disability, injury, or condition and
that the harm would not have occurred in the absence of the vaccination.
Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). In order to
establish that the vaccine was a substantial factor in causing the injury,
petitioner must show: (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 proximate temporal
relationship between the vaccination and injury. Althen, 418 F.3d at 1278. The
same evidence may be used to establish multiple of the Althen prongs.
Capizzano v. Sec’y of HHS, 418 F.3d 1317, 1326 (Fed. Cir. 2006).

       The first prong of the Althen test focuses on whether the vaccine in
question can cause the type of injury alleged. Pafford v. Sec’y of HHS, 451
F.3d 1352, 1356 (Fed. Cir. 2006). This inquiry allows medical opinion as

                                        9
proof, even without scientific studies in medical literature providing “objective
confirmation” of medical plausibility. Althen, 418 F.3d at 1279. The second
prong is concerned with whether the vaccine did cause petitioner’s injury,
which involves the presentation of a “reputable medical or scientific
explanation.” Id. It, like the first prong, however, does not require proof of a
“specific biological mechanism[].” Capizzano, 440 F.3d at 1325 (citing
Knudsen, 35 F.3d at 549). Circumstantial evidence may also be cited to meet
the test. Id. (citing Althen, 418 F.3d at 1280). Finally, the third prong demands
a showing that the injury’s onset occurred “within a time frame 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 HHS, 539 F.3d
1347, 1352 (Fed. Cir. 2008).

       If the petitioner can meet the causation standard, he has established a
prima facie case, and the burden shifts to the government to prove “[by] a
preponderance of the evidence that the [petitioner’s injury] is due to factors
unrelated to the administration of the vaccine described in the petition.” 42
U.S.C. § 300aa-13(a)(1)(B). Walther v. Sec’y of HHS, 485 F.3d 1146, 1151
(Fed. Cir. 2007).

II. Dr. Bourque’s Medical Records Offer An Opinion Of A Causal Link
Between The Hepatitis A Vaccine And Petitioner’s Seizure Disorder

        The Vaccine Act requires petitioners to provide, at a minimum, proof
in the form of medical records or by medical opinion. 42 U.S.C. § 300aa-
13(a)(1) (requiring proof of causation “by medical records or by medical
opinion). Medical records “warrant consideration as trustworthy evidence”
because these records are “generally contemporaneous to the medical events,”
and “accuracy has an extra premium.” Cucuras v. Sec’y of HHS, 993 F.2d
1525, 1528 (Fed. Cir. 1993). The medical records and opinions of treating
physicians are “quite probative” because “treating physicians are likely to be
in the best position to determine whether a logical sequence of cause and effect
show[s] that the vaccination was the reason for the injury. Capizzano, 440 F.3d
at 1326.

       Here, the Special Master considered the records of Dr. Bourque but
found them “not [to] offer any opinions regarding causation between Mr.
Mondello’s receipt of the hepatitis A vaccine and the onset of seizures.”
Mondello, Slip. Op. at 7. She found that the doctor’s records provided only a
history of events prior to and post-vaccination. Thus, petitioner’s choice not

                                       10
to provide an expert opinion causally linking the vaccine to the seizures or
other symptoms suffered by petitioner was fatal to his claim. “Ultimately,
petitioner has failed to provide either a sufficient medical opinion or plausible
medical theory in support of his claim that the hepatitis vaccine caused or
significantly contributed to his seizures.” Id. at 8. Further, the Special Master
decided that the petitioner’s prior medical history (“co-morbidities”), the fact
that he took the particular antihistamine just prior to the onset of seizures, and
his record of having used CNS depressants contemporaneous with the
antihistamine undermined any evidence suggesting a “more likely than not”
link between the vaccine and the injuries suffered by petitioner. Id.

        We cannot go so far. Most of what is contained in Dr. Bourque’s notes
and records is, as stated by the Special Master, a recitation of Mr. Mondello’s
medical history, centering on his 2013 seizure episode. It is of note, however,
that in each record of treatment, Dr. Bourque is careful to continue to point out
the close temporal relationship between the administration of the Twinrix
vaccine and the onset of seizures. Also of importance to her is the fact that
petitioner was sick almost immediately after the vaccination, even prior to
taking the cyproheptadine. Most important, however, is the record from
petitioner’s final visit to Dr. Bourque in March 2016. It states, “Impression and
Plan: Mr. Mondello continues to have a history of hospitalization in November
2013 for suspected provoked seizure, which was likely a combination of being
unwell from a hepatitis A vaccine and the compilation of cyproheptadine . . .
.” Pet.’s Ex. 9 at 1486. That is an opinion regarding causation. As stated in
several of Dr. Bourque’s notes from earlier visits, she viewed the seizure
episode in 2013 as provoked, i.e., not caused by an already existing medical
condition suffered by petitioner. Her notes from petitioner’s final visit indicate
her opinion that the provocation for the seizure was a combination of the
illness suffered as a result of the vaccine and cyproheptadine. We make no
judgment regarding its weight or sufficiency to meet petitioner’s burden under
the Vaccine Act, but we cannot agree that Dr. Bourque provided no opinion
regarding medical causation of the seizure episode.

        Further, there are other pieces of evidence submitted by petitioner that
arguably lend some support to his claim. He submitted two pieces of medical
literature along with Vaccine Information Sheets and a Twinrix package insert
in support of his motion for a decision on the record. The first is a study
entitled “A case-control study of serious autoimmune adverse events following
hepatitis B immunization” by David and Mark Geier. In it, the authors reported
that they found an increased incidence of serious autoimmune disorders

                                       11
following administration of the hepatitis B vaccine to adults as compared to a
control group administered only a tetanus vaccine between the years of 1990-
2004. Pet.’s Ex. 13. The second study presented by petitioner is entitled
“Population-Level Evidence for an Autoimmune Etiology of Epilepsy” by
Mei-Sing Ong, et al. Pet’s Ex. 14. This study found an increased risk of
epilepsy, a seizure disorder, among non-elderly patients with autoimmune
diseases. Petitioner suggests that these two studies, read together, provide
evidence of a biological causation between the hepatitis vaccine and the
seizures experienced by plaintiff. Further, the vaccine information sheets and
Twinrix package insert are cited by petitioner to support the idea that the
illness he experienced during the week after the vaccination but before the
seizure is consistent with the frequent side effects listed for the vaccine that he
was administered.

       Although the Federal Circuit makes clear that claimant need not
produce medical literature or epidemiological evidence to establish causation
under the Vaccine Act, where such evidence is submitted, the Special Master
can consider it to determine whether a vaccine in question did in fact cause a
particular injury. See Althen, 418 F.3d at 1280; see also Capizzano, 440 F.3d
1317 at 1324. Petitioner, however, must provide a reputable medical or
scientific explanation that pertains specifically to the petitioner’s case,
although the explanation need only be “legally probable, not medically or
scientifically certain.” Knudsen v. Sec’y of HHS, 35 F.3d 543, 548-49 (Fed.
Cir. 1994).

        Here, petitioner submitted two pieces of medical literature. The first
found an increased incidence of serious autoimmune adverse effects of
hepatitis B vaccination. Pet.’s Ex. 13 (David A. & Mark R. Geier, A Case-
Control Study of Serious Autoimmune Adverse Events Following Hepatitis B
Immunization, Autoimmunity, June 2005, at 295). The other evaluated how the
risk of serious seizure disorders increases in patients with autoimmune disease.
“[S]pecific autoimmune causes, typically associated with autoantibodies, have
been increasingly identified in a subset of previously idiopathic seizure
disorders. In some of these situations, seizures are associated with other
nerologic manifestation; in others, they are the only sign of neurologic
autoimmunity.” Pet.’s Ex. 14 (Mai-Sing Ong, Isaac S. Kohane, Tianxi Cai,
Mark P. Gorman, Kenneth D. Mandl, Population-Level Evidence for an
Autoimmune Etiology of Epilepsy, JAMA Neurology, 2014, at 569.). This
evidence does not appear to have been considered in the decision below.

                                        12
       Respondent cites to Snyder v. Sec’y of HHS, 36 Fed. Cl. 461, 466
(1996) and Murphy v. Sec’y of HHS, 23 Cl. Ct. 726, 734 n.8 (1991), for the
proposition that a special master need not discuss every piece of evidence in
the record so long as her decision makes clear that she fully considered
petitioner’s relevant evidence and arguments. The government argues that
nothing cited by petitioner provides a reputable medical theory of vaccine
causation, either alone or when considered with Dr. Bourque’s medical
records, and thus the Special Master did not err by not specifically calling this
fact out in her decision.

        We cannot say on review whether this evidence ought to have changed
the Special Master’s decision nor do we make an attempt to consider whether
it is sufficient to provide some proof of etiology. It may well be that expert
testimony would be necessary to elucidate the question of whether these
studies lend any support to petitioner’s claim. We also cannot say, however,
that, on their face, they are irrelevant to petitioner’s claim for compensation.
Nor can we say that we are confident that the Special Master considered them
before rejecting the petition as insufficiently positing a theory of causation.

II. Possible Legal Error Assigning Burden to Petitioner to Eliminate
Alternative Causes

       Finally, the Special Master concluded that the petitioner’s co-
morbidities and the coincidence of other substances in his blood prior to the
seizure episode, when viewed along with the lack of a medical theory of
causation, made it impossible for petitioner to show that the hepatitis
vaccination is “more likely than not” the cause of, or a substantial factor in
causing, the seizures that occurred on November 22, 2013. Mondello, Slip Op.
at 8. Although it is not clear precisely what weight she was assigning
petitioner’s other medical problems and the relationship between the other
substances and the seizures, those were cited as factors in denying petitioner’s
claim.

       The Vaccine Act provides that, when there are multiple independent
potential causes, and petitioner has met his burden on causation, the Secretary
then has the burden to prove, also by preponderance of evidence, that the
vaccination in question did not cause the harm or the injury was in fact caused
by factors unrelated to the vaccine. Walther, 485 F.3d at 1151. Here, Dr.
Bourque opined that it was likely a combination of the vaccine-caused illness
and the cyproheptadine that provoked petitioner’s seizures. The Act only

                                       13
requires a showing of “but for” causation and that the vaccine was a
“substantial factor,” not that the vaccine was the only cause. Thus the
coincidence of another potential causal agent is not fatal to a claim under the
Act. If petitioner meets its burden on causation, then it is the government’s
burden to prove that some other cause is to blame, not petitioner’s to disprove
it. To the extent the Special Master assigned the burden of eliminating
alternative independent potential causes to petitioner, we conclude that she
erred.

                               CONCLUSION

       Because the record contains at least some evidence suggesting a theory
of causation, we find that the Special Master erred in her conclusion that
petitioner’s claim had to be dismissed for not providing any evidence of a
theory of causation. Further, to the extent that petitioner was assigned the
burden of disproving alternate causes, that was error. We make no findings
regarding the sufficiency of Dr. Bourque’s opinion nor the medical literature
submitted. That is left to the Special Master on remand. Accordingly, the
following is ordered:

       1. Petitioner’s motion for review of the Special Master’s November 15,
       2016 decision is granted.

       2. This case is hereby remanded to the Special Master for further
       proceedings consistent with this opinion.

                                           s/Eric G. Bruggink
                                           ERIC G. BRUGGINK
                                           Senior Judge

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