Swick v. Secretary of Health and Human Services

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.

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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.

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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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