Court Opinion

ID: 4314469
Source: CourtListenerOpinion
Date Created: 2018-09-21 16:01:42.818133+00
Date Added: 2024-06-11T14:44:41.392044
License: Public Domain

In the United States Court of Federal Claims
                           OFFICE OF SPECIAL MASTERS
*************************
AMEENA JAAFAR,                 *                     No. 15-267V
on behalf of A.M.,             *                     Special Master Christian J. Moran
                   Petitioner, *
                               *                     Filed: August 10, 2018
v.                             *
                               *                     Entitlement; bench ruling; diphtheria,
SECRETARY OF HEALTH            *                     tetanus, acellular pertussis (“DTaP”)
AND HUMAN SERVICES,            *                     vaccine; tonic seizures; infantile spasms
                               *
                   Respondent. *
*************************

William J. Melley, Law Offices of William J. Melley, III, Hartford, CT, for petitioner;
Debra A. Filteau Begley & Mollie D. Gorney, United States Dep’t of Justice, Washington, DC,
for respondent.

                 PUBLISHED DECISION DENYING COMPENSATION1
        Ms. Jaafar claimed that a diphtheria-tetanus-acellular pertussis (DTaP) vaccination
caused her son, A.M., to suffer infantile spasms.2 After Ms. Jaafar filed A.M.’s medical records,
the parties filed a series of reports from Dr. Maurice Kinsbourne (petitioner’s expert), Dr. Vera
Byers (petitioner’s expert), Dr. Stephen McGeady (respondent’s expert), and Dr. Max Wiznitzer
(respondent’s expert).

       A hearing was held on August 6-8, 2018. After the parties submitted all their evidence,
the undersigned issued a bench decision, finding that Ms. Jaafar had failed to establish that she
was entitled to compensation. See Doe/17 v. Secʼy of Health & Human Servs., 84 Fed. Cl. 691,
704 n.18 (2008) (noting “[e]ven a special master’s ruling on entitlement may be delivered from
the bench, with no written opinion”).

       1
         The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), requires that the Court post this decision on its
website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing
redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4).
Any redactions ordered by the special master will appear in the document posted on the website.
       2
          During rebuttal testimony, petitioner’s experts began to elaborate a second theory that
A.M. first suffered tonic seizures that later evolved into infantile spasms. Because a factual
finding described below rendered this second theory untenable, this decision focuses on the first
theory, that the DTaP vaccine directly caused infantile spasms.
      The undersigned is issuing this document for two reasons. First, this document will
become available to the public pursuant to 42 U.S.C. § 300aa—12(d)(4).

        Second, this document provides an abbreviated recitation for the basis of decision. See
Hebern v. United States, 54 Fed. Cl. 548 (2002) (example of a judge from the United States
Court of Federal Claims formalizing a bench ruling denying a motion for review). As explained
in the bench ruling, the undersigned considered all the evidence, including the medical records,
expert reports, medical articles, and oral testimony. The undersigned’s consideration of this
evidence began when the evidence was received, as outlined in the recitation of the case’s
procedural history. See Vaccine Rule 5 (providing for a framework in which special masters
evaluate the evidence, and even make tentative findings and conclusions, prior to issuing a
decision).

                                               Facts

        Because the parties agreed that medical records created contemporaneously with the
events described in the records accurately set forth events in A.M.’s life and because the parties’
briefs are generally in agreement, only a succinct recitation of facts is presented here.

       A.M. was born in January 2013. Up through his six-month wellness appointment on July
22, 2013, A.M.’s medical history was uneventful. At the appointment, A.M. received the DTaP
and four other vaccines. Two hours after the appointment while shopping at Target, Ms. Jaafar
reported that A.M.’s body stiffened, his eyes rolled back, and the area around his lips turned
blue. On a call that evening, a doctor told Ms. Jaafar to give A.M. Tylenol and to watch for any
more seizure-like activity.

        Two days later on July 24, 2013, Ms. Jaafar brought A.M. to the emergency room
following more seizure-like activity. No fever was reported in association with A.M.’s seizure-
like activity. A video EEG during the hospital stay confirmed a diagnosis of infantile spasms.

         Genetic testing of A.M. later in 2013 did not reveal any mutations that had a known
association with infantile spasms. A.M. did not undergo any further genetic testing. A.M. went
through several anti-seizure medications, combinations of medications, and dietary changes to
treat his seizure condition.

        In 2014, A.M. resumed receiving scheduled vaccinations, including DTaP. In March
2014, at Ms. Jaafar’s request, and over the neurologist’s advice, A.M.’s anti-seizure medications
were decreased and eventually eliminated. Since that time, A.M.’s seizures have not gotten
worse, but they have not decreased in their overall frequency or severity. The parties agreed that
A.M.’s subsequent medical history does not relate to whether the DTaP vaccine caused A.M.’s
infantile spasms.

        At the hearing, Ms. Jaafar testified about A.M.’s current condition. She described that
A.M.’s physical development has been regular but his intellectual and behavioral development
are delayed. A.M. receives various therapies and assistance through an individualized education
plan at his school. Ms. Jaafar noted that he does have behavior issues that require redirection
which otherwise have resulted in self-harm or aggression toward others. While frustrated by the
difficulties that A.M. has, Ms. Jaafar sounded appropriately proud of the progress that A.M. had
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made. As a mother who obviously loves her child, she is deserving of sympathy in her care for a
disabled child.

                                             Analysis

       Ms. Jaafar bears the burden to establish her case on a more-likely-than-not basis. 42
U.S.C. § 300aa-13(a); Bunting v. Secʼy of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir.
1991). The elements are set out in Althen v. Secʼy of Health & Human Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2005).

        As explained in more detail in the bench ruling, Ms. Jaafar failed to meet her burden of
proof. Her case faltered as a result of resting her claim of causation on experts who were
relatively unqualified compared to the respondent’s experts. As a result, petitioner’s case fell far
short of satisfying the three Althen prongs.

                                       Expert Qualifications

         Special masters may consider the relative expertise of testifying experts when weighing
the value of their opinion. See Depena v. Secʼy of Health & Human Servs., No. 13-675V, 2017
WL 1075101 (Fed. Cl. Spec. Mstr. Feb. 22, 2017), mot. for rev. denied, 133 Fed. Cl. 535, 547-48
(2017), aff’d without op., 730 Fed. App’x 938 (Fed. Cir. 2018); Copenhaver v. Secʼy of Health
& Human Servs., No. 13-1002V, 2016 WL 3456436 (Fed. Cl. Spec. Mstr. May 31, 2016), mot.
for rev. denied, 129 Fed. Cl. 176 (2016). At the pre-hearing conference, the parties agreed that
all of the experts were qualified in their respective fields, but they reserved the right to cross-
examine the experts on the weight that should be afforded to their testimony. A comparison of
the immunologists, Dr. Byers and Dr. McGeady, and the neurologists, Dr. Kinsbourne and Dr.
Wiznitzer, both result in a qualifications advantage for the Secretary.

                                          Immunologists

        Dr. McGeady has superior qualifications to discuss the immunological mechanism that
allegedly triggered A.M.’s infantile spasms. To start, Dr. McGeady is board-certified in
pediatric immunology and Dr. Byers is not. While on a reduced schedule now, Dr. McGeady
practices medicine by treating patients for immunological issues. By contrast, Dr. Byers stopped
her regular practice of medicine in approximately 2002 and now sees patients only in the context
of legal cases. Dr. McGeady has been a professor of pediatrics for over 40 years. Dr. Byers
currently holds no academic position, although she was an adjunct professor as recently as 2008.

       The contrast in qualifications carried over to their respective presentations. Dr. Byers did
not answer questions clearly or cite specific exhibits to support her points. As detailed in the
bench ruling, Dr. Byers made several statements that strained credulity.3 Dr. McGeady
explained the basis of his opinions in an understandable way.

       3
        In regard to the deficiencies of Dr. Byers’s reports and preparation for testifying, the
undersigned has more fully articulated similar problems with Dr. Byers in a recent decision. See
Wood v. Sec’y of Health & Human Servs., No. 15-1568V, 2018 WL 1150730, at *5-8 (Fed. Cl.
Spec. Mstr. Feb. 1, 2018).
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                                          Neurologists

       Although Dr. Kinsbourne has had a long career in neurology and involvement in the
Vaccine Program, the most recent phase of his career has had a shallower connection to pediatric
neurology clinical care. Dr. Kinsbourne has not regularly treated patients for over 20 years and
his most recent academic position starting in 1995 was as a professor of psychology. As for
presentation, Dr. Kinsbourne struggled to make fine distinctions or to distinguish the relevance
of some medical literature over others.

       In contrast, Dr. Wiznitzer is in the midst of a clinical pediatric neurology practice in
which he has recently treated patients with infantile spasms. He also has been certified to read
EEG’s and reviewed A.M.’s actual EEG’s during the litigation. Dr. Wiznitzer answered
questions directly and provided citations to support his statements.

                                            Diagnosis

        In Broekelschen v. Sec'y of Health and Human Servs., 618 F.3d 1339, 1346 (Fed. Cir.
2010), the Federal Circuit recognized that in some circumstances, the special master may “first
determine which injury was best supported by the evidence in the record before applying the
Althen test.” Citing Broekelschen, the Federal Circuit has also explained that “In the absence of
a showing of the very existence of any specific injury of which the petitioner complains, the
question of causation is not reached.” Lombardi v. Sec'y of Health & Human Servs., 656 F.3d
1343, 1353 (Fed. Cir. 2011).

        The parties agree that infantile spasms was the correct diagnosis at the time of A.M.’s
first hospital stay on July 24-26, 2013. However, during the testimony of Dr. Kinsbourne and
Dr. Byers, a disagreement between the parties became more pronounced over what A.M.
experienced two hours after he received the DTaP vaccination on July 22, 2013. The petitioner’s
expert reports and pre-hearing briefs contain faint references to A.M. first experiencing tonic
seizures that then developed into infantile spasms. When petitioner’s experts began to elaborate
on this sketch of a theory, respondent objected on the basis that the theory had not be adequately
disclosed in advance of the hearing. Rather than determining whether the petitioner’s tonic
seizure theory was adequately disclosed, the undersigned will address the evidence relating to the
diagnosis for A.M. at two hours following the DTaP vaccination.

        A weight of the evidence supports a finding that A.M.’s behavior in Target was a
manifestation of infantile spasms. Several factors contribute to this finding. The undersigned
relies on Dr. Wiznitzer’s opinion that A.M. first experienced infantile spasms based on the
strength of his qualifications described above. While Dr. Kinsbourne emphasized that A.M.
cried out and stiffened his limbs to support a diagnosis of tonic seizures, he did not counter Dr.
Wiznitzer’s explanation that infantile spasms can have a tonic component. Further, as described
by Ms. Jaafar, the duration of A.M.’s tonic symptoms were brief, a few seconds, rather than the
longer period of time in typical full tonic seizures, 30-60 seconds. Based on Dr. Wiznitzer’s
definitions of tonic seizures and infantile spasms, Ms. Jaafar’s description of A.M.’s actions two
hours after the DTaP vaccination fits the definition of infantile spasms. Finally, neither Ms.
Jaafar nor her experts identified any record from a treating doctor diagnosing A.M. with tonic
seizures. Thus, the undersigned finds that the evidence preponderates in finding that the episode

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two hours following the DTaP vaccination was, as Dr. Wiznitzer explained, a manifestation of
infantile spasms.

                                       Althen Prong Three

       The easiest way to explain why Ms. Jaafar failed to meet her burden is to begin with the
timing prong. Timing contains two parts: (1) what the expected time interval between the
vaccination and injury for which inference of causation is and (2) whether the onset of the
vaccinee’s injury fell within that expectation.

       It is straight forward to establish the onset of A.M.’s injury because the parties do not
dispute Ms. Jaafar’s testimony about what happened to A.M. two hours after his DTaP
vaccination. In accordance with the ruling on diagnosis above, A.M. suffered an infantile spasm
two hours after his DTaP vaccination.

        As for the expected time interval, Ms. Jaafar is advancing a theory that the innate
immune system had developed a memory from earlier vaccinations that facilitated a significant
enough release of cytokines to cause infantile spasms in A.M. within two hours. Based on the
medical textbooks submitted into evidence, which both immunologists accept as authorities,
even the “trained” innate immune system takes at least four hours to generate a response. Dr.
Byers never clearly identified any medical literature that supported the idea that innate immune
system memory, versus the standard innate immune system, would have a response time less
than four hours. The literature did support the idea, accepted by both immunologists, that, in
some situations, a “memory” aspect to the innate immune system could provoke a more robust
response that the standard innate immune system. But, Dr. Byers did not establish that this more
robust response was a quicker response.

        Thus, the undersigned finds that Ms. Jaafar has failed to establish the Althen timing
prong. Although an absence of preponderant evidence on one Althen prong defeats Ms. Jaafar’s
case, the undersigned will address the other prongs for a complete evaluation of Ms. Jaafar’s
case.

                                        Althen Prong One

        Althen prong one requires the petitioner to present a theory explaining how the relevant
vaccine can cause the relevant illness. Due to the ruling on diagnosis above, only the theory that
the DTaP vaccination directly caused infantile spasms will be considered. The theory that the
DTaP vaccination can cause tonic seizures that can turn into infantile spasms does not fit the
facts of this case, and, therefore, is no longer viable.

        Ms. Jaafar had initially presented a molecular mimicry theory via Dr. Shafrir, but after he
stepped away from the case Dr. Kinsbourne and Dr. Byers pursued a two-hit theory. The experts
posited that the first hit was that A.M. possessed an underlying susceptibility (unknown in this
case) that was then triggered by the second hit, the DTaP vaccination, to release cytokines that
caused the infantile spasms. This theory was not persuasive.

      The critical aspect of the theory is the second hit, whether vaccines can trigger infantile
spasms. Given that an underlying susceptibility, such as a genetic mutation, is unknown in this

                                                 5
case, Ms. Jaafar’s theory is not bolstered by the establishment of a first hit. Moreover, Dr.
Kinsbourne admitted during testimony that having an underlying susceptibility would not be
absolutely necessary for cytokines to trigger infantile spasms.

         Dr. Byers’s opinion that a DTaP vaccination can cause the release of cytokines that can
then trigger infantile spasms is unsupported. Although epidemiological evidence is not a
required for Ms. Jaafar to prevail, the parties presented epidemiological studies. No
epidemiological evidence supports a causal connection between the DTaP vaccine and infantile
spasms.

        To support her theory that the DTaP vaccine can cause infantile spasms, Dr. Byers relies
on medical literature that investigated the connection between the DTaP vaccine and seizures
generally, but not infantile spasms specifically. The neurologists acknowledged that infantile
spasms differ from other seizure types. When asked to explain how she could extend a theory
based on animal models for seizures to a human being suffering from infantile spasms, Dr. Byers
said that she could not. This concession significantly undermined the petitioner’s case.

        As for the mechanism of cytokines, Dr. Byers opined that the DTaP vaccination would
lead to cytokines and cytokines can lead to seizures. Although Dr. McGeady agreed that
vaccines cause the production of cytokines, he opined that physiologic amounts of cytokines do
not cause seizures. On this point, the weightier evidence supports a finding that seizures cause
increases in cytokines, not the other way around.

       Overall, the undersigned finds Dr. Byers’s cytokine theory to be conclusory and not
persuasively supported. Thus, Ms. Jaafar has failed to establish a medical theory that a DTaP
vaccination causes a release of cytokines that triggers infantile spasms.

                                       Althen Prong Two

        Ms. Jaafar failed to establish a logical sequence of cause and effect causally connecting
the DTaP vaccine to A.M.’s infantile spasms. As admitted by Dr. Byers on the stand, there is no
clinical evidence to support Ms. Jaafar’s theory other than the infantile spasms themselves.

        Several pieces of clinical evidence suggests that A.M. did not react the way Dr. Byers’s
cytokine-driven theory would predict. Dr. McGeady contended persuasively that if cytokines did
cause the infantile spasms, then he would expect a fever to accompany the infantile spasms.
However, the parties agree that the medical records do not show that A.M. had a fever in
connection with any of his infantile spams. Similarly, if A.M.’s infantile spasms were the result
of an immune reaction, Dr. McGeady stated that using ACTH, an anti-seizure medication that
targets an immune mechanism, would be effective. But, when doctors tried ACTH on A.M., it
did not alter his infantile spasms.

        In considering whether petitioners have met their burden on prong two, the Federal
Circuit directed special masters to consider the views of treating doctors. Capizzano v. Secʼy of
Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). Here, Dr. Byers recognized that
none of A.M.’s treating doctors linked his vaccines to his infantile spasms. Moreover, A.M.’s
treating doctors advised that he resume receiving his vaccinations. A.M. did not experience a

                                                6
worsening of seizure activity following a subsequent DTaP vaccination, indicating that his case
does not fulfill the challenge-rechallenge paradigm. See Capizzano, 440 F.3d at 1325-26.

       Thus, the undersigned finds that Ms. Jaafar has not established a logical sequence of
cause and effect causally connecting the DTaP vaccine to A.M.’s infantile spasms.

                                         *       *       *

       In summary, for the reasons noted above and further elucidated in the bench ruling, the
undersigned finds that Ms. Jaafar has not met her burden of proof under the Vaccine Act. The
evidence does not support, by a preponderance of the evidence, that A.M.’s DTaP vaccination
caused his infantile spasms.

       The undersigned further directs the Clerk’s Office to enter judgment based upon the
decision in this case if a motion for review is not filed. When the time for filing a motion for
review (see Vaccine Rule 23) begins to run is for an appellate tribunal to decide.

       IT IS SO ORDERED.

                                                             s/Christian J. Moran
                                                             Christian J. Moran
                                                             Special Master

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