Court Opinion

ID: 4258841
Source: CourtListenerOpinion
Date Created: 2018-03-28 14:04:00.335187+00
Date Added: 2024-06-11T12:14:07.193711
License: Public Domain

In the United States Court of Federal Claims
                                  OFFICE OF SPECIAL MASTERS

*************************
RYAN L. SWICK and MARY M. SWICK, *
legal representatives and parents of their *                 No. 13-526V
deceased minor child, J.R.S.,              *                 Special Master
                                           *                 Christian J. Moran
                    Petitioners,           *
                                           *                 Filed: February 26, 2018
v.                                         *
                                           *                 Entitlement, infant’s death,
SECRETARY OF HEALTH                        *                 posterior reversible
AND HUMAN SERVICES,                        *                 encephalopathy syndrome
                                           *                 (PRES)
                    Respondent.            *
*************************

Richard H. Moeller, Berenstein, Moore, Heffernan, Moeller & Johnson, L.L.P.,
Sioux City, IA, for petitioners;
Ryan D. Pyles, United States Dep’t of Justice, Washington, DC, for respondent.

            PUBLISHED DECISION DENYING COMPENSATION1

       The facts in this case are sad. A medical examiner found that the death of
J.R.S., who was nearly 3 months old, was “unexplained.” Exhibit 6 at 15. J.R.S.’s
parents, Ryan L. Swick and Mary M. Swick, claim that vaccinations caused their
son to die approximately 17 days following their administration.

       Although their story is emotionally compelling, the petitioners’ evidence is
not legally persuasive. Beyond sympathy, the Swicks’ claim that the vaccinations
caused J.R.S.’s death depends on the value of an opinion from their expert, Walter
E. Kozachuk, a doctor who specializes in neurology. However, his qualifications

       1
         The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,
2002), requires that the Court post this ruling 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.
and credentials in the relevant disciplines are not as strong as the background of
Michael H. Kohrman, a board-certified neurologist whom the Secretary has
retained. Besides the disparity in credentials between the experts, the diagnosis
that Dr. Kozachuk has proposed is not reliable or persuasive. Dr. Kozachuk has
opined that J.R.S. suffered from posterior reversible encephalopathy syndrome
(PRES), but the evidence does not support this diagnosis. Because the remainder
of Dr. Kozachuk’s opinion that the vaccinations caused J.R.S.’s death depends
upon the diagnosis of PRES, Dr. Kozachuk’s overall opinion on causation is not
persuasive. A full discussion follows.

                                            Facts2

       The relevant facts in this tragic case can be stated relatively succinctly.3 For
a more detailed recitation of information, see Ruling Finding Facts, issued Jan. 7,
2016; Pet’rs’ Proposed Findings of Fact, filed Dec. 22, 2014; and Resp’t’s Resp. to
Pet’rs’ Proposed Findings of Fact, filed Jan. 20, 2015.

       After a gestation of 36 weeks and 3 days, J.R.S. was born on May 14, 2011.
Soon after delivery, he had some difficulty breathing and required intubation for
less than 24 hours. Exhibit 10 at 2-3. Although he had some additional difficulties
with feeding (an immature and disorganized suck), he gained weight shortly after
being born.

       J.R.S. often experienced constipation that seemed to make him fussy. J.R.S.
had a well-child examination on July 25, 2011. Concerns included constipation
that glycerin suppositories were helping and crying from 2:00 AM to 7:00 AM
daily. Exhibit 2 at 25. During this appointment, J.R.S. received the hepatitis B,
rotavirus, diphtheria-tetanus-acellular pertussis, haemophilus influenzae type b,
inactivated poliovirus, and pneumococcal conjugate vaccines. Id. at 26.

       Between July 25, 2011, and August 11, 2011, J.R.S. continued to have
episodes of constipation during which he was fussy. In early August, he vomited a
large amount once. Findings of Fact at 14-15.

       2
         As discussed in the procedural history below, some of the facts were found after a
hearing during which percipient witnesses testified.
       3
        In accord with 42 U.S.C. § 300aa-13(a)(1), the undersigned has considered the entire
record. However, this decision does not discuss all the evidence.

                                                   2
      In the days before J.R.S.’s death on August 11, 2011, his mother, father, and
two older siblings were ill with colds. Exhibit 6 at 11 (medical examiner’s
questionnaire). In the evening of August 10, 2011, J.R.S. began to cough and his
coughing woke him from his sleep. Findings of Fact at 15.

       The evidence regarding whether J.R.S. was placed on his back (supine) or
stomach (prone) was inconsistent and no finding is required. J.R.S. was found in
the prone position. A blanket was covering his head. Exhibit 6 at 10; Findings of
Fact at 15.

       When Mrs. Swick found J.R.S., he was warm to the touch, sweaty, pale,
limp, and still. His face and lips were not blue, but the area below J.R.S.’s lips
started to turn blue just before Mrs. Swick stopped performing CPR. Findings of
Fact at 15.

       Mrs. Swick called 911 and emergency medical technicians arrived at their
house at approximately 10:00 AM. J.R.S. did not show signs of life. Exhibit 4 at
1, 2, 6; exhibit 5 at 9. The EMTs brought J.R.S. to a local hospital, where he was
pronounced dead at 10:39 AM. Exhibit 5 at 10, 11, 21.

       Dennis F. Klein, M.D., a deputy state medical examiner, performed an
autopsy on August 12, 2011. From the autopsy, Dr. Klein submitted a brain
specimen to the University of Iowa for a neuropathologic consultation. Exhibit 6
at 16. The neuropathologist, Patricia A. Kirby, M.D., examined the brain on
September 2, 2011, and submitted her report on September 7, 2011. Id. at 28. Dr.
Klein sent his report to various people on September 12, 2011. Id. at 14.

       In her neuropathology report, Dr. Kirby found “the midbrain, medulla and
pons show congestion with focal perivascular hemorrhages in the pons. The basal
meninges are congested with smear subarachnoid hemorrhages. The cerebral
cortex has persistent but involuting external granular layer.” Dr. Kirby continued:
“[t]he neocortex shows no acute or remote hypoxic-ischemic neuronal injury and
there is no cortical lamination anomaly.” She also found “the white matter is
within normal limits.” Exhibit 6 at 29-30. Dr. Kirby’s case summary states
“examination of the brain fails to reveal a C[entral] N[ervous] S[ystem] cause of
death. Although somewhat non-specific, the findings would be in keeping with an
asphyxial death.” Id. at 28.

      The opinion of the medical examiner, Dr. Klein, was that J.R.S. died of
“sudden unexplained infant death.” Id. at 20. Dr. Klein added: “Due to the
circumstances of how the decedent was found, prone with blanket covering the
                                            3
head and the non-specific findings in the brain that would be in keeping with
asphyxia[,] death caused by asphyxia cannot be ruled out. The manner of death is
UNDETERMINED.” Id. at 21.

                                    Procedural History4

       The Swicks allege a vaccination, or combination of vaccinations, caused
J.R.S.’s death. Pet., ¶¶ 21, 23. To support their claim for compensation,
petitioners filed medical records (exhibits 1-6, 8-10) and affidavits (exhibits 7, 15).
In addition, petitioners were ordered to file an expert report outlining the basis of
their theory. Dr. Kozachuk’s first report opined that J.R.S. died as a result of
PRES, which can begin soon after vaccination and can last for weeks if it is not
fatal. Exhibit 11 at 12. In presenting PRES as a diagnosis, Dr. Kozachuk also
argued over the course of approximately seven pages that J.R.S. did not die from
SIDS. Id. at 1-7, 12.5

       The Secretary filed a Rule 4 report shortly after Dr. Kozachuk’s report, and
concluded there was insufficient evidence to prove petitioners are entitled to
compensation. Resp’t’s Rep. at 10. With the report, the respondent submitted blog
posts by Mrs. Swick that called into question the factual basis for some of Dr.
Kozachuk’s assumptions. Id. at 7-9. As to Dr. Kozachuk’s opinion, the Secretary
noted that Dr. Kozachuk has presented an opinion involving primarily immunology
and pathology. Given Dr. Kozachuk’s focus on neurology, the Secretary
“question[ed] Dr. Kozachuk’s qualifications to opine in these specialized fields,
especially since his opinion appears to contradict the conclusion of the medical
examiner.” Id. at 9-10.

      The case was then transferred to the undersigned. Order, filed June 5, 2014.
Following the transfer, Dr. Kozachuk authored a supplemental expert report in
response to the Secretary’s Rule 4 report. This report was filed on August 19,
2014. The supplemental report concluded that additional autopsy studies were
required to rule out SIDS as a cause of death and to establish a more certain cause

       4
         The procedural history largely, but not entirely, repeats the procedural history provided
in the Ruling Finding Facts.
       5
       The Swicks filed the articles that Dr. Kozachuk cited in his January 6, 2014 report in
March 2017.

                                                    4
of death. See exhibit 13 at 2. Dr. Kozachuk also identified a neuroscientist and
molecular biologist who could perform additional studies. Id. at 3.

        After reviewing the filings in the case, the undersigned determined that there
were factual discrepancies concerning the time period from J.R.S.’s vaccination to
his death. On October 30, 2014, a fact hearing was held to address factual
discrepancies in the record by evaluating the testimony of the affiants. Five people
testified. The undersigned considered their testimony as well as the documentary
evidence.

      Following the hearing, the Swicks suggested findings of fact. Pet’rs’
Proposed Findings of Fact, filed Dec. 22, 2014. The Secretary addressed those
proposals. Resp’t’s Resp. to Pet’rs’ Proposed Findings of Fact, filed Jan. 20, 2015.
On January 7, 2016, the undersigned issued a Ruling Finding Facts.

      In the ensuing status conference, the undersigned asked whether the Swicks
wanted to obtain additional expert reports, including reports from the doctors
whom Dr. Kozachuk identified in his second expert report. The undersigned also
asked whether the Swicks wanted to obtain additional material from the autopsy.
For both questions, the Swicks indicated that they would consider these ideas. The
Swicks also stated that they intended to obtain a revised report from Dr. Kozachuk
in which he considered the Findings of Fact just issued.

        The Swicks presented a new report from Dr. Kozachuk on April 29, 2016.
Exhibit 21. While Dr. Kozachuk noted the Findings of Fact, the essence of his
opinion did not change. Dr. Kozachuk stood by his assertion that J.R.S. suffered
from PRES, not SIDS. For more information about SIDS, Dr. Kozachuk
recommended that Dr. Kinney, a prominent researcher in this field, be consulted.
Dr. Kozachuk also maintained that the vaccinations caused J.R.S. to suffer PRES.
Id. at 2.

        In the next status conference, the Swicks’ attorney represented that he
intended to attempt to consult with Dr. Kinney. However, the undersigned
informed Mr. Moeller that Dr. Kinney appears not interested in participating in
litigation. The Secretary’s attorney stated that he had learned that the Maryland
State Board of Physicians had reprimanded Dr. Kozachuk. Later, on the day of the
status conference, the Secretary filed the public order of reprimand as exhibit D.
Mr. Moeller stated that he would consult his clients about their preferred course of
action.

                                             5
       In a July 11, 2016 status report, the Swicks stated that they were attempting
to consult with Dr. Miller, a neuropathologist who has testified on behalf of other
petitioners in the Vaccine Program. In the next status conference, the Secretary
questioned whether there was a reasonable basis for continued pursuit of this
claim.

       On August 17, 2016, the Swicks stated in a status report that they were not
retaining Dr. Miller. Accordingly, the next step was to allow the Secretary time to
respond to Dr. Kozachuk’s reports. Order, issued Aug. 24, 2016.

      The Secretary’s expert is Dr. Kohrman. Dr. Kohrman disputed the diagnosis
of PRES based upon the autopsy. Dr. Kohrman also stated: “[J.R.S.]’s autopsy is
consistent with asphyxia as noted by the medical examiner but was ruled a SIDS
case. He was at risk for SIDS based on his prematurity, and being found in the
prone position with his head covered.” Exhibit E at 10. Dr. Kohrman also opined:
“There is no evidence to link the causation of J.R.S.’s death to his vaccinations on
July 25, 2011.” Id.

       In the status conference to discuss Dr. Kohrman’s report, the Swicks were
asked whether they wanted to obtain a responsive report from Dr. Kozachuk. The
Swicks expressed some interest in conferring with Dr. Kozachuk, and also
proposed consulting with Dr. Miller again. See order issued Nov. 10, 2016. Any
efforts were not fruitful as the Swicks stated that they would not be presenting any
more expert reports. See Pet’rs’ Status Rep., filed Jan. 19, 2017.

      In a February 9, 2017 status conference, the parties discussed ways of
submitting the case for adjudication. The Swicks stated that a hearing was unlikely
to generate new evidence, and, therefore, the special master should decide the case
based upon experts’ reports. The Secretary agreed that the case could be submitted
on the papers.

     Following this status conference, the Swicks filed the articles that Dr.
Kozachuk had cited in his first report. The Secretary filed four additional articles.

       Once the evidence was complete, the parties were ordered to submit briefs
and, within the briefs, to address the reliability of Dr. Kozachuk’s opinion in light
of the Secretary’s revelation that the Maryland State Board of Physicians had
reprimanded him. The Swicks filed a brief on June 12, 2017. The Swicks
generally supported their claim. With respect to Dr. Kozachuk’s discipline, the
Swicks maintained that Dr. Kozachuk had not misrepresented his credentials
because “[h]is reports were submitted before any disciplinary action was taken and
                                                6
before any sanctions were imposed.” Pet’rs’ Br. at 14. The Swicks further argue
“the underlying allegations and findings in the disciplinary action do not challenge
Dr. Kozachuk’s credibility.” Id. Finally, they also argue that Maryland law would
preclude a finder of fact from considering the disciplinary report. Id. at 15 n.5
(citing Pepsi Bottling Group v. Plummer, 130 A.3d 1047, 1059 (Md. App. 2016)).

      The Secretary responded on August 2, 2017. For Dr. Kozachuk, the
Secretary argued that although the special master could consider his reports, they
should be given less weight. Resp’t’s Br. at 16-19.

      Because the time for filing a reply brief has expired, the case is ready for
adjudication.

                                      Analysis

      The Swicks have failed to present preponderant evidence that the
vaccinations caused J.R.S.’s death. Two points underlie this conclusion.
Preliminarily, Dr. Kozachuk has offered opinions in fields in which he lacks
expertise and Dr. Kozachuk’s background in neurology is not as strong as Dr.
Kohrman’s background in neurology. The second and more important reason for
denying compensation is that the Swicks have not established that J.R.S. suffered
from PRES.

I.    Dr. Kozachuk’s Expertise
       The question of Dr. Kozachuk’s qualifications was first raised more than
three years ago. The Secretary’s report specifically noted the discrepancy between
Dr. Kozachuk’s practice area, neurology, and the disciplines on which he was
opining.

      Multiple cases have endorsed a special master’s consideration of an expert’s
credentials. 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), appeal docketed, No. 2017-2527 (Fed. Cir. Sep. 8, 2017);
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). In this light, a recitation of the expert’s qualifications is appropriate.

      Dr. Kozachuk lists his credentials on his curriculum vitae, which was filed
on January 6, 2014, as exhibit 12. Dr. Kozachuk attended college in Canada and
received a medical degree from the University of Saskatchewan in 1980. He had a
                                              7
rotating internship at the Hurley Medical Center in Flint, Michigan from 1980 to
1981. Then for approximately two years, he worked as a family physician. From
1983 through 1986, he was a neurology resident at the Cleveland Clinic
Foundation and, in the following year, he worked as an internal medicine resident
at the same institution. From 1988 through 1990, Dr. Kozachuk held a fellowship
at the National Institute on Aging in the laboratory of neuroscience. Next, he
worked at Johns Hopkins Medical School as an associate in CNS vasculitis. He
also was simultaneously working as a neurologist in private practice. Exhibit 12 at
6.

       It appears that in December 1993, Dr. Kozachuk’s focus shifted as he began
working for various companies investigating pharmaceuticals. This work seems to
have lasted through 2001. See id. at 3-4. Since 1996, he has worked as “part-time
neurological consultant” to various private practices. Most of this work appears to
focus on treating patients with “head trauma and spinal cord injury.” Id. at 2. As
of the submission of his curriculum vitae, Dr. Kozachuk’s “current position” was
at the “Neuroscience Team,” which provides “clinical diagnoses of patients with
both Neurological and Neuropsychological conditions.” Id.6

       As the Secretary points out (Resp’t’s Br. at 7-8), Dr. Kozachuk’s curriculum
vitae is also notable for what it does not say. For example, the curriculum vitae
does not list a board certification with the American Board of Psychiatry and
Neurology. The curriculum vitae does not list any teaching responsibilities at a
university or hospital. The curriculum vitae does not list any current hospital
privileges with the most recent affiliation occurring in 1994.

       These absences lead the Secretary to argue: “Head to head in the field of
neurology, respondent’s expert, Dr. Kohrman, obviously has far superior
credentials to Dr. Kozachuk.” Resp’t’s Br. at 7. Dr. Kohrman received a medical
degree from Rush Medical College in Chicago, Illinois, in 1981. He then had an
internship and residency in the pediatric Department of the University of Chicago
Hospitals and Clinics. He then had a three-year fellowship in pediatric neurology
again at the University of Chicago. In 1987, he became board-certified in
psychiatry and neurology with a special competency in child neurology. In that
same year, he also became board-certified in pediatrics. He has since obtained

       6
         The Secretary presented an excerpt from the website theneuroscienceteam.com that
indicates that Dr. Kozachuk’s areas of special interest include “Reactions to Vaccines, and the
study of Autoimmunology.” Exhibit C at 1.

                                                    8
more board certifications in various other disciplines. Exhibit F (curriculum vitae)
at 2.

      Beginning in 1986 and continuing for more than three decades, Dr. Kohrman
has served as faculty member at various medical schools. One of his current
responsibilities is to direct the Department of Pediatric Neurology at Akron
Children’s Hospital. Id. at 1.

       Dr. Kohrman’s curriculum vitae lists other achievements, such as authoring
articles, conducting pharmaceutical research, and acting as a peer reviewer for
various journals. These contributions further demonstrate Dr. Kohrman’s expertise
in the field of neurology.

       The field of neurology, however, is not the only relevant field. Dr.
Kozachuk has offered opinions about immunology (explaining how a vaccine can
cause PRES) and pathology (challenging the finding that J.R.S. died from SIDS).
Dr. Kozachuk forthrightly identified other doctors who would be more qualified to
issue opinions about these topics. See exhibit 11 at 12 ¶ 15; exhibit 13 at 3.
However, the Swicks did not present a report from anyone who concurred with Dr.
Kozachuk’s opinions in this case.

       Like Dr. Kozachuk, Dr. Kohrman appears to lack any specialized training in
immunology and pathology. However, any deficit in Dr. Kohrman’s background
carries less consequence because the petitioners bear the burden of presenting a
persuasive case. See Dean v. Secʼy of Health & Human Servs., No. 13-808V,
2017 WL 2926605, at *18 n.12 (Fed. Cl. Spec. Mstr. June 9, 2017).

      In short, ample evidence supports a finding that on neurologic topics, Dr.
Kohrman has more extensive expertise. The evidence also supports a finding that
neither Dr. Kozachuk nor Dr. Kohrman is particularly knowledgeable in
immunology and pathology. These findings are important for the analysis that
follows in the section below.

       But, before leaving the topic of qualifications and credentials, there is one
more topic to explore — Maryland’s reprimand of Dr. Kozachuk. Procedurally, it
is important to note that Dr. Kozachuk’s three reports and the Maryland
disciplinary order are exhibits in this case. The Secretary did not file a motion to
strike Dr. Kozachuk’s reports and the Swicks did not file a motion to strike the
disciplinary order. Thus, because the reports and the disciplinary order are part of
the record, the undersigned must consider them. See 42 U.S.C. § 300aa-13(a).

                                             9
       The directive for a special master to determine compensation based upon
“the record as a whole” appears tempered by Vaccine Rule 8(b)(2), stating the
special master “must consider all relevant and reliable evidence.” This
qualification implicitly seems to recognize that “the record as a whole” may
contain some evidence that might not be relevant and some that might not be
reliable. Cf. Paterek v. Secʼy of Health & Human Servs., 527 F. App’x 875, 884
(Fed. Cir. 2013) (noting that a special master does not commit legal error in
finding some medical history “not relevant”).

      Thus, the ensuing question is: is the Maryland disciplinary order relevant?
(As an order from an adjudicatory body, the order is prima facie reliable.) The
Secretary argues that the Maryland disciplinary order is relevant to Dr. Kozachuk’s
credibility as an expert witness. Quoting Contreras v. Secʼy of Health & Human
Servs., 121 Fed. Cl. 230, 238 (2015) (Contreras VI), vacated on other grounds, 844
F.3d 1363 (Fed. Cir. 2017)), the Secretary contends “‘an expert who is not credible
does not, as a general rule, provide reliable expert testimony.’” Resp’t’s Br. at 18.

       The Maryland disciplinary order reduces Dr. Kozachuk’s credibility. While
the underlying misconduct may not directly affect Dr. Kozachuk’s credibility as
defined by the Federal Rule of Evidence 608, the more important issue is that Dr.
Kozachuk displayed a lack of candor by not bringing forth the discipline against
him. As to this point, the Swicks’ defense of Dr. Kozachuk is based upon an error
in regard to the disclosure of his discipline.

       The Swicks assert that Dr. Kozachuk’s “reports were submitted before any
disciplinary action was taken and before any sanctions were imposed.” Pet’rs’ Br.
at 14. The foundation for this argument is an assertion that “Dr. Kozachuk’s most
recent report was filed on August 19, 2014.” Id. However, as the Secretary noted,
“Petitioners appear to have inadvertently missed Dr. Kozachuk’s report that was
internally dated by him on April 29, 2016.” Resp’t’s Br. at 17 n.8. Thus, Dr.
Kozachuk had an opportunity in his April 2016 report to disclose the reprimand
from his licensing body issued on April 25, 2016. Dr. Kozachuk’s lack of candor
makes his case similar to the lack of candor displayed by the Secretary’s expert in
Contreras VI, 121 Fed. Cl. at 239 (noting that the expert witness’s lack of candor
was one of five reasons that special master should have “at the very least . . .
significantly discount[ed]” the opinion from that expert).

      While Dr. Kozachuk’s failure to disclose the reprimand diminishes his
credibility, ultimately this lapse did not alter the decision in this case. Dr.
Kozachuk’s main deficit is his lack of qualifications. Dr. Kozachuk’s lack of

                                            10
experience is separate from any misgivings about his disciplinary record and his
lack of disclosure. In other words, even if Dr. Kozachuk had not engaged in any
conduct warranting professional discipline that he should have disclosed, the
outcome would have been the same.

II.   Dr. Kozachuk’s Diagnosis of PRES
       The parties dispute whether J.R.S. suffered the injury for which the Swicks
seek compensation. On this issue, the Swicks bear the burden of proof.
Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1346 (Fed. Cir.
2010); Lombardi v. Sec'y of Health & Human Servs., 656 F.3d 1343, 1352 (Fed.
Cir. 2011) (“under Broekelschen, identification of a petitioner's injury is a
prerequisite to an Althen analysis of causation”). In doing so, the special master is
“not ‘diagnosing’ vaccine-related injuries.” Knudsen v. Sec'y of Health & Human
Servs., 35 F.3d 543, 549 (Fed. Cir. 1994). Rather, the special master evaluates the
evidence presented and determines whether the petitioners have met their burden
of establishing that the vaccinee suffers from the disease. See Lombardi, 656 F.3d
at 1353–56 (reviewing evidence that the special master considered in determining
whether petitioner suffered from a particular disease and finding that the special
master's factual findings were not arbitrary or capricious).

       In the discussion of whether the Swicks met their burden of establishing, by
preponderant evidence, that J.R.S. suffered from PRES, the parties touch on the
diagnostic criteria. See Pet’rs’ Br. at 24-26 (citing Dr. Kozachuk’s reports and
four articles); Resp’t’s Br. at 9 (citing Dr. Kohrman’s report and two articles). An
abstract from a case report of a 19-year-old pregnant woman with PRES states
“Diagnosis of the syndrome can be difficult.” Exhibit 33 (Mehtap Honca et al.,
Posterior Reversible Encephalopathy Syndrome in an Eclamptic Patient After
Cardiac Arrest; Case Report and Literature Review, 42 Turk. J. Anaesth. Reanim.
50-53 (2014)) at 50.7

       For setting out relevant diagnostic factors, the Endo article is useful because
it focuses on pediatric cases of PRES. These authors defined PRES as “a clinical
and radiological syndrome, characterized by headache, confusion, seizures, and
visual disturbance associated with transient characteristic lesions on neuroimaging,
predominantly in the posterior part of the brain.” Exhibit 29 (Ayumi Endo et al.,
Posterior reversible encephalopathy syndrome in childhood: report of four cases
and review of the literature, 28(2) Pediatr Emerg Care 153-57 (2012)) at 153.

      7
          The petitioners’ cover page to exhibit 33 does not cite the article accurately.

                                                     11
Whether PRES can occur in children as young as J.R.S. is not entirely clear as
another article analyzed pediatric cases of PRES and found that none happened in
an infant. Exhibit E, tab 4 (Vivek Gupta et al., Imaging Findings in Pediatric
Posterior Reversible Encephalopathy Syndrome (PRES): 5 Years of Experience
From a Tertiary Care Center in India, 31(9) J. Child Neuro. 1166-73 (2016)) at
1167.

       While Gupta states an “autopsy in posterior reversible encephalopathy
syndrome is distinctly rare,” id. at 1171, the record in this case contains one article
about the neuropathology of a fatal PRES case. The authors in that article reported
that at the autopsy from an eight-year-old girl, “the occipital and cerebellar white
matter and focal occipital cortical gray matter showed a spectrum of microvascular
changes.” Exhibit 40 (John N. Kheir et al., Neuropathology of a fatal case of
posterior reversible encephalopathy syndrome, 13(5) Pediatr. Dev. Pathol. 397-403
(2010)) at 397.

       To support Dr. Kozachuk’s diagnosis of PRES in J.R.S., the Swicks cite two
symptoms and one set of signs as identified by him. For symptoms, the Swicks
point to J.R.S.’s fussiness after the July 25, 2011 vaccinations, which may have
been due to constipation, and the single episode of vomiting. To the Swicks,
J.R.S.’s fussiness “correlated to symptoms of headache, confusion, and decreased
alertness in adult.” Pet’rs’ Br. at 25. For signs of PRES, Dr. Kozachuk notes
various findings on J.R.S.’s autopsy. See id. at 24, quoting exhibit 11 (Dr.
Kozachuk’s first report) at 12.

      The Swicks’ presentation is not persuasive. As to symptoms, the fussiness
can be set aside because it is more likely than not that J.R.S. was constipated. See
exhibit E at 9-10. Eliminating fussiness leaves a single episode of vomiting,
involving a relatively large amount of vomit. However, vomiting – even large
amounts – is relatively common in children less than four months as any parent
knows. This is far too slender a reed to support the PRES diagnosis.

       As to signs at autopsy, the Swicks are in a difficult position because they are
taking a position contrary to the evaluation of the neuropathologist who examined
J.R.S.’s brain. Dr. Kirby’s case summary states “examination of the brain fails to
reveal a CNS cause of death. Although somewhat non-specific, the findings would
be in keeping with an asphyxial death.” Exhibit 6 at 28. Implicitly, the Swicks are
challenging Dr. Kirby’s finding, essentially arguing that she missed signs of PRES.
In trying to establish, on a more likely than not basis, the soundness of Dr.
Kozachuk’s diagnosis, the Swicks have a challenging task, as autopsy reports “are

                                             12
contemporaneous records made by a health care professional outside the context of
litigation, and should be given the same probative weight as other medical
records.” Nordwall v. Sec’y of Health & Human Servs., 83 Fed. Cl. 477, 488
(2008), app. dismissed voluntarily, 331 Fed. App’x 720 (Fed. Cir. 2009). The
Swicks’ challenge is even greater because in trying to overturn Dr. Kirby’s
neuropathological finding, they are relying upon a doctor who appears to have no
specialized training in neuropathology and who even recommended that they seek
the assistance of a neuropathologist. Under these circumstances, the Swicks have
failed to present persuasive evidence that J.R.S.’s autopsy supports the finding of
PRES.8

       In finding that the Swicks failed to meet their burden of proving that J.R.S.
had PRES, the undersigned has considered the parties’ arguments about whether
J.R.S.’s death should alternatively be categorized within the group known as
Sudden Infant Death Syndrome (SIDS). This general debate encompasses a
specific controversy over the significance or non-significance of how J.R.S. was
found on the morning of his death — on his stomach. Overall, these disputes were
not particularly insightful. While ruling out other possible reasons for J.R.S.’s
death could advance the Swicks’ case to some degree, the Swicks do not prevail
simply by establishing, on a more likely than not basis, that J.R.S. did not die from
asphyxia or SIDS. The Swicks’ burden is to establish that J.R.S. had PRES.9 For
the reasons explained above, the evidence falls far short.

       8
          A final piece of evidence weighing against the Swicks is that the Secretary’s expert, Dr.
Kohrman, stated that J.R.S.’s autopsy “demonstrated no evidence for PRES.” Exhibit E at 9.
While Dr. Kohrman’s opinion aligns with Dr. Kirby’s conclusion, Dr. Kohrman’s opinion about
neuropathology seems to suffer from a similar impairment as Dr. Kozachuk’s opinion: a relative
lack of expertise in neuropathology. In addition, Dr. Kohrman’s analysis is relatively
conclusory. Given the numerous technical terms in the autopsy, the Secretary would have been
better served if Dr. Kohrman had explained more thoroughly how he reached his opinion. For
these reasons, the undersigned has not given Dr. Kohrman’s opinion about neuropathology much
weight.
       9
         Dr. Kozachuk’s opinion is that J.R.S. did not die from SIDS. Exhibit 21. Although Dr.
Kozachuk recommended additional studies and additional experts, the Swicks did not obtain
them. Thus, the Swicks base their claim “upon the facts showing that J.R.S.’s demise was not
consistent with the usual associations of SIDS, and instead that the child died as a result of
posterior reversible encephalopathy syndrome, or PRES, caused by his vaccinations.” Pet’rs’ Br.
at 16.

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       The Swicks have failed to establish that Dr. Kozachuk presented a
persuasive opinion that J.R.S. suffered from PRES. This gap in their proof means
that they are not entitled to compensation.

III.   Vaccines as a Potential Cause of PRES
       Even if the Swicks had established on a more-likely-than-not basis that
J.R.S. suffered from PRES, they would still be required to prove with preponderant
evidence that the vaccines caused J.R.S.’s PRES. This evaluation would require an
assessment of the evidence in light of the Federal Circuit's three-prong test set forth
in Althen v. Secʼy of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir.
2005). See Broekelschen, 618 F.3d at 1350.

       The parties submitted evidence in support of their respective positions. This
evidence included the reports from the experts, medical literature, and testimony
from the experts. The parties summarized this evidence in their briefs. See Pet’rs’
Br. at 19-36; Resp’t’s Br. at 13-16. The undersigned has considered the evidence
and arguments.

       Nevertheless, the undersigned declines to determine, strictly as a
hypothetical matter, how the causation evidence preponderates. As the Federal
Circuit has explained, “[i]n 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, 656 F.3d at 1353.

      In addition, the inquiry into causation is “frequently more difficult.”
Hibbard v. Secʼy of Health & Human Servs., 698 F.3d 1355, 1365 (Fed. Cir.
2012). Since any analysis would necessarily be counter-factual in that it would
assume that J.R.S. suffered from PRES when preponderant evidence shows that he
did not, exploring the more challenging question of whether any relevant vaccine
can cause PRES is not necessary to decide the Swicks’ case. Therefore, no
findings are made regarding their proof under Althen.

                                     Conclusion

     The loss of a beloved child so early in his life caused immense grief for the
Swicks. They deserve sympathy.

      However, special masters are tasked with determining whether petitioners
have established that they are entitled to compensation based upon the evidence.
Here, the Swicks have not established, on a more likely than not basis, a critical
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step in their proof — namely, that J.R.S. suffered from PRES. Without this
predicate finding, the Swicks cannot prevail.

      The Clerk’s Office is instructed to issue a judgment in accord with this
decision.

      IT IS SO ORDERED.

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

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