VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-00154
Package ID: USCOURTS-cofc-1_17-vv-00154
Petitioner: K.E.L.
Filed: 2017-02-01
Decided: 2023-09-01
Vaccine: DTaP
Vaccination date: 2014-02-26
Condition: epileptic spasms, global developmental delay, acquired microcephaly, and encephalopathy
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On February 1, 2017, Erik and Lisa Lindholm, on behalf of their minor son K.E.L., filed a petition for compensation under the National Vaccine Injury Compensation Program. They alleged that a DTaP vaccination administered on February 26, 2014, caused K.E.L. to develop epileptic spasms, global developmental delay, acquired microcephaly, and encephalopathy. The Petitioners claimed that shortly after vaccination, K.E.L. experienced uncontrollable crying and jerking spells, followed by lethargy and developmental regression. Medical records indicated K.E.L. was diagnosed with infantile spasms around 10 months of age, with subsequent developmental delays and microcephaly. The petition alleged a Table injury of encephalopathy within 72 hours of vaccination and alternatively, an "off-Table" claim for causation-in-fact. Respondent contested entitlement, arguing that no evidence supported a Table encephalopathy and that K.E.L.'s microcephaly predated the vaccination. The case involved expert reports from Dr. L. Douglas Wilkerson for the Petitioners, who opined that the vaccine likely caused K.E.L.'s condition, and Dr. Michael H. Kohrman for the Respondent, who concluded that K.E.L.'s progressive microcephaly predated the vaccination and was the underlying cause of his infantile spasms. The Special Master, Katherine E. Oler, found that the evidence did not demonstrate a Table encephalopathy, as the reported symptoms did not meet the Table's definition and were contradicted by contemporaneous medical records. Furthermore, the Special Master determined that Petitioners failed to establish causation-in-fact under the Althen test. Specifically, the Special Master found no reliable medical theory linking the DTaP vaccine to K.E.L.'s condition, that K.E.L.'s microcephaly and abnormal brain development predated the vaccination, and that the onset of symptoms did not occur within a medically acceptable timeframe to infer causation. The public decision does not describe the specific mechanism of injury alleged by Petitioners or Respondent's specific arguments regarding the clinical story beyond the expert opinions. The petition was denied. Petitioners were represented pro se at the time of the decision. Respondent was represented by Mark Kim Hellie of the U.S. Department of Justice.

Theory of causation field:
Petitioners alleged that K.E.L., who received a DTaP vaccine on February 26, 2014, suffered from epileptic spasms, global developmental delay, acquired microcephaly, and encephalopathy. They pursued both a Table claim for encephalopathy within 72 hours of vaccination and an off-Table claim for causation-in-fact. Petitioners' expert, Dr. L. Douglas Wilkerson, opined that the DTaP vaccine likely caused K.E.L.'s condition, suggesting an "unspecified immune mechanism" and a temporal link between vaccination and symptom onset, though he acknowledged the exact mechanism was elusive and the onset difficult to pinpoint. Respondent's expert, Dr. Michael H. Kohrman, concluded that K.E.L.'s progressive microcephaly predated the vaccination and was the underlying cause of his infantile spasms and developmental delay, finding no evidence of vaccine causation and that the symptoms did not meet the Table definition of encephalopathy within the required timeframe. Special Master Katherine E. Oler denied the petition, finding that Petitioners failed to establish a Table encephalopathy due to lack of evidence and contradiction with medical records. For the off-Table claim, the Special Master found Petitioners failed to meet the Althen test: (1) Prong One (medical theory) was not met due to Dr. Wilkerson's conclusory opinions lacking a sound and reliable explanation of how the DTaP vaccine could cause the alleged injuries; (2) Prong Two (logical sequence of cause and effect) was not met as evidence indicated K.E.L.'s microcephaly and abnormal brain development predated the vaccination, and the Special Master found the elimination of other causes insufficient without more; and (3) Prong Three (proximate temporal relationship) was not met as the onset of symptoms was not established within a medically acceptable timeframe, with contemporaneous medical records indicating onset much later than alleged by Petitioners and their expert. The decision was issued on September 1, 2023, with Petitioners represented pro se and Respondent represented by Mark Kim Hellie.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-00154-2
Date issued/filed: 2023-09-01
Pages: 37
Docket text: PUBLIC DECISION (Originally filed: 7/28/2023) regarding 94 DECISION of Special Master. Signed by Special Master Katherine E. Oler. (emh) Service on parties made. Petitioner served via first class mail on this day Modified on 9/6/2023 (vds).
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Case 1:17-vv-00154-UNJ Document 96 Filed 09/01/23 Page 1 of 37
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-0154V
Filed: July 28, 2023
Reissued for Public Availability: September 1, 2023
* * * * * * * * * * * * * * * * * * * * * * * * *
ERIK LINDHOLM and LISA LINDHOLM, *
on behalf of K.E.L., *
*
Petitioners, *
*
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Erik Lindholm and Lisa Lindholm on behalf of K.E.L., Pro Se
Mark Kim Hellie, U.S. Department of Justice, Washington, DC, for Respondent
DECISION DENYING COMPENSATION1
Oler, Special Master:
On February 1, 2017, Erik Lindholm (“Mr. Lindholm”) and Lisa Lindholm (“Ms.
Lindholm”) (collectively “Petitioners”) filed a petition for compensation under the National
Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine Act” or
“Program”) on behalf of their minor son, K.E.L., alleging that K.E.L. suffered from injuries,
including epileptic spasms, global developmental delay, acquired microcephaly, and
encephalopathy as a result of a DTaP vaccination3 he received on February 26, 2014. Petition
1 Pursuant to Vaccine Rule 18(b), this decision was initially filed on July 28, 2023, and the parties were
afforded 14 days to propose redactions. The parties did not propose any redactions. Accordingly, this
decision is reissued in its original form for posting on the Court’s website.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to subparagraph of 42 U.S.C. § 300aa (2012).
3 K.E.L. received the Pediarix vaccine, a combined vaccine containing DTaP vaccine, hepatitis B vaccine,
and inactivated polio vaccine. Ex. 3 at 31-32.
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(“Pet.”) at 1. For the reasons discussed in this decision, I find that Petitioners have not
demonstrated that the DTaP vaccine caused K.E.L.’s condition.
I. Procedural History
Petitioners filed a petition on February 1, 2017, alleging that their son, K.E.L., developed
the Table injury of encephalopathy within 72 hours of vaccination with the diphtheria, tetanus, and
pertussis vaccine (“DTaP” or “Pediarix”),3 and alternatively that his epileptic spasms, global
developmental delay, and acquired microcephaly were “caused-in-fact” by the DTaP vaccination
K.E.L. received on February 26, 2014. Pet. at 1, 8, ECF No. 1. On February 6, 2017, Petitioners
filed 23 medical record exhibits and Statement of Completion. Ex. 1-23, ECF No. 6-7.
On May 25, 2017, Respondent filed a Rule 4(c) report contesting entitlement in this case.
Respondent argued that there is no evidence in the record to support a claim that K.E.L. suffered
a Table encephalopathy following his receipt of the February 26, 2014 Pediarix vaccination.
Respondent’s Rep. at 7. Respondent noted that the affidavits submitted by Petitioners regarding
onset “squarely contradict what petitioners told K.E.L.’s medical providers at the time they first
sought medical treatment for his claimed injured and must be heavily scrutinized on that basis.”
Id. at 7-8. Thus, Respondent argued that Petitioners must pursue a causation-in-fact claim for
which no expert report had been submitted. Id. at 8-9.
On February 19, 2018, Petitioners filed an expert report and curriculum vitae prepared by
Dr. L. Douglas Wilkerson. ECF No. 32 (“First Wilkerson Rep.”). On May 29, 2018, Respondent
filed an expert report prepared by Dr. Michael H. Kohrman. Exs. A-B, ECF No. 34. Both Dr.
Wilkerson and Dr. Kohrman filed supplemental expert reports on February 20, 2020, and June 22,
2020, respectively. ECF Nos. 49, 53. Thereafter, Petitioners filed a status report stating that they
wanted their expert to respond to Dr. Kohrman’s most recent expert report. ECF No. 54. However,
over the next few months and after a number of motions for enlargement of time were granted,
Petitioners’ counsel filed a motion to withdraw from the case. ECF Nos. 59-60. I granted this
motion on October 14, 2021, and Petitioners are currently acting pro se.
On December 15, 2021, I held a status conference with the parties to discuss the next steps
in the case. Scheduling Order, ECF No. 73. Ms. Lindholm indicated that she was searching for a
new attorney and requested 45 days to provide an update. Id. I granted that request. Id.
Over the next six to eight months, I ordered Petitioners to file numerous status reports to
update me on their progress in securing new legal representation. ECF Nos. 73, 75, 77, 89.
Petitioners corresponded with my law clerk on several occasions, but failed to contact my
chambers or file a status report regarding their efforts after March 21, 2022. See Informal
Communication Remark dated 4/20/2022. On April 20, 2022, I issued another order giving
Petitioners 30 days to provide me with an update. See Scheduling Order dated 4/20/2022, ECF No.
77. Petitioners failed to contact my chambers or file a status report.
On May 26, 2022, after reviewing the records and expert reports filed in this case, I issued
a scheduling order containing additional questions posed to Respondent’s expert, Dr. Kohrman.
ECF No. 81.
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On August 8, 2022, I issued another order directing Petitioners to provide me with an
update regarding their efforts to secure legal representation by September 7, 2022. ECF No. 89. I
informed Petitioners that a failure to file a status report or contact my chambers would result in
the issuance of an Order to Show Cause. Id. at 2. Petitioners did not contact my chambers or file a
status report as directed. On September 9, 2022, I issued an Order to Show Cause for failure to
prosecute and for failure to follow court orders, giving Petitioners until October 11, 2022, to file a
response. ECF No. 90. In the Order to Show Cause, I notified Petitioners that their failure to
provide a response “will be interpreted as a failure to prosecute this claim, and the petition shall
be dismissed.” Id. Petitioners have filed no response to date.
On September 30, 2022, Respondent filed another expert report prepared by Dr. Kohrman
in response to the questions posed in my May 26, 2022 Order. With no further response from
Petitioners, I find that this matter is now ripe for a decision.
II. Medical Records
A. Relevant Pre-Vaccination Medical History
K.E.L. was born on August 19, 2013 (Exhibit “Ex.” 1), via cesarean section with no serious
complications. See generally Ex. 2. For the first six months of life, K.E.L. received his routine
childhood vaccines at the Avera McGreevy Clinic on schedule and without issue. Ex. 2 at 24-34,
92; Ex. at 3, 30-32.
K.E.L.’s head circumference measurement at birth on August 28, 2013, was 34.29
centimeters, over the 50th percentile. Ex. 2 at 14, 16. The head circumference measurements from
birth to age 22 months are depicted in the following chart:
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Ex. 16. No other pediatric records have been filed.
B. Post-Vaccination Medical History
On February 26, 2014, K.E.L. received the allegedly-causal Pediarix vaccine, his third dose of
the three-dose series, during his six-month well-child visit. Ex. 2 at 190-91; Ex. 3 at 3, 31-32; Ex. 27 at 1.
During this visit, the medical records note that K.E.L. had positive development for a six-month old; he
babbled, reached for objects, rolled both ways, and was able to sit up unassisted for brief periods. Ex. 27
at 1. At this six-month well-child visit, it is noted that K.E.L.’s head circumference measurement had
dropped to the 8th percentile. Ex. 16 at 1.
On April 2, 2014, 35 days later, K.E.L. was brought to his pediatrician, Dr. Shelby Eischens, for
complaints of decreased appetite, cough, not acting himself which started four days prior. Ex. 27 at 5.
K.E.L.’s mother also reported he had a low-grade fever the night prior, although she noted that he “seems
happier this morning.” Id. at 6. K.E.L. was noted to have swelling along his upper and lower gum lines
and was assessed with nasal congestion. Id. at 7. Dr. Eischens felt that K.E.L.’s symptoms could be related
to “teething vs mild viral URI.” Id. She recommended topical VapoRub as needed with instructions to
return if the child worsened or developed new symptoms. Id.
On May 29, 2014, K.E.L. returned to Dr. Eischens for his nine-month well child visit. Ex.
27 at 9. It was noted that K.E.L. had begun to crawl, that he looked for dropped toys, that he was
able to say “mama” and “dada”, he sat without support, and could transfer objects from hand to
hand. Id. at 10. Dr. Eischens noted that K.E.L. appeared as a “healthy, happy baby” with “good
bonding with mom.” Id. His next well-child visit was noted to be at one year. Id. at 12. At this
visit, the medical records document that K.E.L.’s head circumference had now fallen below the
third percentile. Ex. 16 at 1.
On June 14, 2014, nearly 15 weeks after vaccination, K.E.L. (now 10 months old) was taken to
the Emergency Department (“ED”) at Brookings Health System for complaints of lethargy. Ex. 2 at 92-
95. Ms. Lindholm reported to Dr. Andrew Ellsworth, the treating physician, that for the last month, K.E.L.
had been “pretty lazy and laying around a lot.” Id. at 92. She reported that the child’s pediatrician, Dr.
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Eischens, felt that K.E.L. may have been teething as he was experiencing low-grade fevers at the time. Id.
Because K.E.L. could not see Dr. Eischens until June 26, 2014, Petitioners took him to the ED for
evaluation. Id. Although K.E.L. was not experiencing any specific events at the time he was brought to
the ED, Mrs. Lindholm wanted him evaluated because of an “episode of turning blue but woke up and
then was fine” and that he did not “coo or talk anymore like he used to either.” Id.
Treating physician, Dr. Jim F. Walery, noted that when he first walked in the room, K.E.L. was
asleep and difficult to rouse. Ex. 2 at 93. Dr. Walery noted that K.E.L.’s ears were slightly red on the right,
but his physical examination was otherwise normal. Id. Dr. Walery also noted that K.E.L. barely reacted
to a blood draw, but 15 minutes later, he was awake, sitting in mom’s lap, and “acting quite normal.” Id.
K.E.L. was able to roll over and sit up unassisted when laid on his stomach. Id. Dr. Walery noted “mild
lethargy” in his assessment and instructed Petitioners to follow up with Dr. Eischens, K.E.L.’s pediatrician,
for a review of all the lab work and further discussion regarding testing. Id. Dr. Walery also noted,
[p]ossible other avenues to investigate would be blood exposure or perhaps even West
Nile virus, a seizure disorder or some other complex genetic abnormality. Overall, this
child just doesn’t seem to appear normal at times. At other times he seems to be acting
quite appropriately. I was impressed by his initial lethargy or disconnect from me during
the initial exam but once I strongly stimulated him, he seemed to act more appropriate…
Id.
Another physician, Dr. Andrew Ellsworth, was consulted to perform a second opinion
examination. Ex. 2 at 92-93. On examination, Dr. Ellsworth noted that K.E.L. was alert and “mildly
fussy.” Id. Ms. Lindholm reported that when K.E.L. was on his stomach, he did not move. Id. However,
on examination, K.E.L. was able to sit up without assistance when laid on his stomach. Id. In the
assessment, Dr. Ellsworth noted that K.E.L. appeared alert and had a “completely normal examination”
at that time. Id. at 93. Dr. Ellsworth also documented that the results of a chest x-ray and basic metabolic
panel were normal. Id.; Ex. 2 at 32. K.E.L. was discharged home with instructions to check his temperature
twice daily and to administer Tylenol or Motrin if his temperature exceeded 100.5 degrees. Id. at 91.
Petitioners were also instructed to follow up with K.E.L.’s primary care provider (“PCP”). Id.
Five days later, on June 19, 2014, K.E.L. presented to Dr. Germano Falcao at AMG Pediatric
Specialists on follow up for complaints of seizures. Ex. 9 at 8; Ex. 10 at 12-13. Dr. Falcao noted on
neurological exam that “Patient is noted to be sleepy (almost lethargic appearing). Reacts to light touch.
Unable to assess further.” Id. at 9. Concerns for infantile spasms were noted and an EEG study was ordered
to assess for hypsarrhythmia.4 Id.
4 Hypsarrhythmia is defined as “an electroencephalographic abnormality sometimes observed in infants,
with random, high-voltage slow waves and spikes that arise from multiple foci and spread to all cortical
areas. It is seen most commonly in cases of jackknife seizures.” Dorland. (2011). Dorland's Illustrated
Medical Dictionary E-Book. London: Saunders.
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Later that same day, June 19, 2014, K.E.L. underwent his first EEG study. Ex. 10 at 10-11. No
EKG (cardiac) abnormalities were noted but his EEG5 was abnormal with evidence of hypsarrhythmia
patterns. Id. A pediatric hospitalist was notified with a plan to admit K.E.L. on an urgent basis for a workup
of infantile spasms. Id. at 11. K.E.L. was also to start a six-week adrenocorticotropic6 hormone therapy
(“ACTH”) medication course. Id.
K.E.L. was evaluated by Dr. Mina Hafalah after the EEG study was completed. Ex. 10 at 13. After
reviewing his history and the results of the EEG study, Dr. Hafalah diagnosed K.E.L. with infantile spasms
“by history and EEG recording (hypsarrhythmia).” Id. She requested that K.E.L. be urgently admitted in
order to start a six-week course of ACTH therapy. Id.
From June 19, 2014, to June 25, 2014, K.E.L. was admitted to McKenna Hospital and University
Health Center due to infantile spasms “and the need to initiate ACTH therapy.” Ex. 25 at 40. In the history
of present illness, it is noted that,
[t]his is a previously healthy 10-month-old who had been well in his normal state of health
up until a month back when the mother noticed that he was not acting himself anymore.
He was becoming more lethargic, just wanted to be left alone, did not want to be held, and
he then started having multiple episodes around 2 to 3 times a day of abnormal
movements that initially they thought were scaring him, and that was brought to the
attention of his pediatrician, but unfortunately at that point in time she was unable to look
at any videos or witness the episodes herself, so she wanted the family to continue
monitoring… he was then transferred to Dr. Germano Falcao for further management …
Upon review of his developmental history, it is obvious that he is actually starting to lose
developmental milestones unfortunately. Initially he was able to sit up at 6 months of age
and he was able to roll over at 3 months of age, but since this happened, he is unable to sit
up without support anymore, and he is not always maintaining eye contact…
Id. K.E.L. was admitted “with West syndrome” and ACTH therapy was initiated. Id. at 43.
A progress note dated June 20, 2014, stated “[t]his is a 10-month-old male who was in a normal
state of health until a month prior when he began having increased lethargy, increased abnormal
movement episodes which appear in clusters at times.” Ex. 25 at 50. It was noted that K.E.L. had
experienced two episodes since his admission, one episode lasting four minutes and another lasting three
5 An EEG or electroencephalogram is defined as “a recording of the potentials on the skull generated by
currents emanating spontaneously from nerve cells in the brain. The normal dominant frequency of these
potentials is about 8 to 10 cycles per second and the amplitude about 10 to 100 microvolts. Fluctuations in
potential are seen in the form of waves, which correlate well with different neurologic conditions and so
are used as diagnostic criteria.” Dorland. (2011). Dorland's Illustrated Medical Dictionary E-Book.
London: Saunders.
6 “This medication is used to treat a certain type of seizure in children (infantile spasms). This medication
is also used to treat conditions such as multiple sclerosis, arthritis, lupus, eye conditions, skin/kidney/lung
diseases, and immune system disorders. It decreases your immune system's response to various diseases to
reduce symptoms such as swelling, pain, and allergic-type reactions. Corticotropin is a hormone.”
https://www.webmd.com/drugs/2/drug-53492/acth-injection/details
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minutes. Id. K.E.L. underwent a brain MRI on June 20, 2014, which was negative for any abnormalities.
Ex. 25 at 123.
On June 24, 2014, while hospitalized, K.E.L. underwent another EEG exam to evaluate the
etiology of the infantile spasms, for ACTH therapeutic drug monitoring, and for comparison with his prior
EEG. Ex. 10 at 7. No EKG abnormalities were noted, but an abnormal EEG study documented a
“moderately severe disorganized background more obvious during drowsiness” and “evidence of
multifocal interictal epileptiform discharges.” Id. at 8. The comments on the study stated that there was a
remarkable improvement on the EEG background compared to patient’s prior EEG recording dated June
19, 2014, that had a clearcut hypsarrhythmia pattern. This EEG is indicative of a positive response to
ACTH treatment. In addition, since started ACTH, patient has been seizure free, (infantile spasms) for
more than 48 hours…” Id.
On June 25, 2014, K.E.L. was discharged. Ex. 25 at 35. The medical records document that
he remained afebrile during his admission. Id. at 36. K.E.L. experienced a total of three infantile
spasms during his admission. Id. His weakness, alertness, and the number of spasms had all
improved following ACTH therapy. Id.
The next month, on July 7, 2014, K.E.L. returned to Dr. Falcao for follow up. Ex. 9 at 4.
The parents reported that K.E.L. was a “little irritable” but otherwise doing ok. Id. No seizure
activity was reported. Id. On examination, Dr. Falcao noted that K.E.L. was awake, alert, active,
and smiling during the visit. Id. Dr. Falcao also noted that “[t]his is a remarkable improvement
from when I first met him, he appeared to be mostly lethargic and sleeping all the time.” Id. at 6.
The assessment described a “gladly remarkable improvement during the six-week course of
ACTH” with “complete resolution of hypsarrhythmia pattern by repeat EEG” and normal brain
MRI. Id. Dr. Falcao cautioned that K.E.L. was at increased risk of future seizures and
developmental concerns and instructed Petitioners to return in four weeks for a repeat EEG. Id.
On the evening of August 3, 2014, and into the morning of August 4, 2014, K.E.L. was
seen at the ED for complaints of nausea, vomiting and diarrhea. Ex. 2 at 111-115. The record from
this visit noted that K.E.L. was seen earlier that day in the urgent care clinic for similar complaints.
Id. His white blood count was elevated and there was a concern that he may have had a bacterial
infection. Id. . The assessment was “[l]eukocytosis with associated nausea, vomiting and diarrhea.”
Id. at 112. K.E.L. received an antibiotic injection and was discharged with instructions that his
parents keep him hydrated. Id.
On August 12, 2014, K.E.L. (11 months old) presented to Dr. Germano Falcao at AMG
Pediatric Specialists for follow up on infantile spasms after the completion of ACTH injections.
Ex. 9 at 1. Dr. Falcao noted that although K.E.L. was no longer receiving the injections, he was
doing well with no seizure activity reported. Id. K.E.L.’s mother stated that he was recently ill with
the flu, but he did not experience seizures during that visit. Id. K.E.L. was described to be sleeping
better, although his appetite remained sporadic. Id. at 112-14.
K.E.L. underwent another EEG study immediately after this visit. Ex. 10 at 5. While no
EKG heart abnormalities were noted, there were some EEG brain abnormalities observed during
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the study. Id. The report noted that there was “a complete resolution of the prior documented
hypsarrhythmia” pattern. Id.
On October 13, 2014, K.E.L. presented to Dr. Falcao for follow up regarding his infantile
spasms. Ex. 9 at 1. After this visit, K.E.L. underwent another EEG evaluation for concerns of
infantile spasms and breakthrough seizures. Ex. 10 at 1-2. The EEG results were abnormal and
were indicative of “possible Lennox-Gastaut syndrome.”7 Id. at 2.
On November 6, 2014, K.E.L. was seen by Certified Nurse Practitioner, Kimberly Berg
(“CNP Berg”), at the Minnesota Epilepsy Group, P.A., for a review of his EEG results obtained
earlier that day and to discuss treatment options. Ex. 7 at 6. The medical record described that
K.E.L. had a history significant for West Nile syndrome and infantile spasms status post ACTH
therapy. Id. At the time, Petitioners reported that K.E.L. was averaging approximately two seizures
per day, lasting one to two minutes and up to five minutes in clusters. Id. CNP Berg reviewed the
results of K.E.L.’s current EEG, which was abnormal, and the results of previous EEGs and MRIs.
Id. at 8. She recommended that K.E.L. begin Topamax, with increases in dosage over three to four
weeks. Id. Clonazepam was also added in increasing dosages as tolerated. Id. She instructed
Petitioners to call her in three weeks with an update on K.E.L.’s condition. Id.
On December 29, 2014, K.E.L. returned to CNP Berg in follow up. Ex. 7 at 1. K.E.L. had
undergone an MRI of his head and brain earlier in the day which was normal. Id. at 12. CNP Berg
noted that despite the new medications, K.E.L. continued to have seizures. Id. Petitioners reported
that the seizures appeared to be less intense, although he was still experiencing one to four cluster
seizures per day. Id. CNP Berg noted that K.E.L.’s head circumference had fallen below 5%. Id.
CNP Berg instructed that the medications should be maximized and the dosing schedule
completed. Id. She also encouraged Petitioners to obtain genetic testing in order to have an epilepsy
panel completed. Id. Petitioners were instructed to follow up in three months. Id.
On January 13, 2015, Petitioners presented with K.E.L. to Dr. Laura Davis-Keppen at the
Sanford Clinic in Sioux Falls, South Dakota, after being referred by Dr. Eischens for K.E.L. to
undergo a genetic evaluation for his developmental delays and seizures. Ex. 11 at 1. Dr. Laura
Davis-Keppen noted,
The mother believes that his development was normal in early infancy. He was
diagnosed with infantile spasms at 9 months of age, and then had a developmental
regression… Parents were informed that his head circumference is relatively small
but they believe this was not present at birth. There is a[] family history of smaller
than average head circumference. Id. at 1-2. Dr. Davis-Keppen noted that she
wanted to speak with K.E.L.’s pediatric neurologist to obtain records of all of his
testing, including any genetic testing. Id. at 4. She noted that K.E.L.’s mother
believed that the child’s seizures were a result of an immunization, and she
requested Dr. Davis-Keppen’s opinion.
7 Lennox Gastaut syndrome is defined as “an atypical form of absence epilepsy characterized by diffuse
slow spike waves, often with atonic, tonic, or clonic seizures and intellectual disability; there may also be
other neurologic abnormalities or multiple seizure types. Unlike typical absence epilepsy, it may persist
into adulthood.” Dorland. (2011). Dorland's Illustrated Medical Dictionary E-Book. London: Saunders.
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Id. at 2.
On March 31, 2015, K.E.L. returned to Dr. Davis-Keppen for a follow up appointment. Ex.
11 at 20-25. After assessing K.E.L.’s current condition, Dr. Davis-Keppen recommended that a
comprehensive epilepsy panel be ordered for further evaluation. Id. at 25. She stated that the
“differential diagnosis for the cause of seizures is quite diverse and complex, and more than half
of all epilepsies have been attributed to a genetic cause.” Id. She noted that knowing the genetic
basis of a patient’s epilepsy is valuable for obtaining a definitive diagnosis, estimating prognosis,
determining recurrence risk, and guiding treatment choices. Id.
K.E.L. underwent a comprehensive seven-day epilepsy evaluation at the Mayo Clinic by
pediatric neurologist, Dr. Paul E. Youssef (supervised by Dr. Eric Payne and Dr. Katherine
Nickels) from April 21-28, 2015. Ex. 8 at 74-76, 129-33. During intake, K.E.L.’s mother reported
that K.E.L. started to have epileptic spasms in March 2014, when he was six to seven months of
age.8 Ex. 8 at 109. Following treatment with ACTH for six weeks in June 2014, K.E.L. was seizure
free and experienced developmental improvement until September 2014. Id. Since then, he had
continued to experience seizures. Id.
While at the Mayo Clinic, K.E.L. underwent a head MRI, which was normal with no
structural abnormalities. Ex. 8 at 74. He also underwent a CSF (cerebral spinal fluid) examination
which yielded normal results. Id. at 74-75. K.E.L. was also monitored in the Pediatric Epilepsy
Monitoring unit from April 24, 2015, to April 27, 2015. Id. at 76. The results of the prolonged
video-EEG were abnormal with one episode of whole-body spasm observed. Id. The report
documented that these observations and results were consistent with an epileptic spasm. Id. At the
conclusion of the seven-day evaluation, Petitioners were informed that the etiology of K.E.L.’s
spasms, developmental delay, and acquired microcephaly remained undetermined. Id. at 76. Dr.
Youssef noted in his report that he remained “highly suspicious that [K.E.L’s] symptoms [were]
of a genetic etiology” and arrangements had been made for more extensive metabolic testing. Id.
Varied treatment options were discussed, and K.E.L.’s Clonazepam dose was increased. Id. at 75-
76.
On May 7, 2015, Dr. Youssef noted that he had reviewed the most recent results of K.E.L.’s
remaining biochemical and metabolic testing conducted during K.E.L.’s April evaluation. Ex. 8 at
74. Dr. Youssef noted “[i]n summary, our extensive biochemical and metabolic evaluation in the
serum, urine, and cerebrospinal fluid has not found a biochemical, metabolic, or autoimmune
etiology for [K.E.L.’s] seizures and developmental delay.” Id.
On May 14, 2015, K.E.L.’s mother contacted Dr. Youssef with concerns that K.E.L. may
have been having side effects related to the recent increase in his seizure medication, Clonazepam.
Ex. 8 at 72. K.E.L.’s mother reported that over the prior two weeks, K.E.L. had a total of five
epileptic spasms characterized by sudden head drop with flexion of the trunk and elevation of both
upper limbs lasting several seconds. Id. She also reported that he went for a period of four days
without any spasms. Id. She felt that the higher doses of Clonazepam had not been effective and
caused K.E.L. to become fussier and his gait to become more unsteady. Id. Dr. Youssef counseled
8 This is the first time Ms. Lindholm reported that K.E.L. began having seizures in March 2014.
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K.E.L.’s mother on adjusting the medication dosages. Id. On June 2, 2015, K.E.L.’s mother called
Dr. Youssef with similar complaints about an increase in the number of spasms. Id. at 71. Dr.
Youssef again counseled on adjusting the medication dosages. Id.
On June 5, 2015, K.E.L. established care with Dr. Rick Kooima for his seizure disorder.
Ex. 3 at 21. Dr. Kooima noted that K.E.L. had been followed by Dr. Falcao who treated him for
infantile spasms. Id. It was noted that K.E.L.’s spasms had previously ceased for two months but
then returned. Id. Currently, K.E.L. was documented as having 10 to 20 of these episodes in a row
lasting up to 20 minutes. Id. The episodes were reported to happen four times per week. Id. The
assessment was seizure disorder and developmental delay. Id. at 22. Petitioners were instructed to
follow up with neurology at the Mayo Clinic and continue with the prescribed medications. Id.
On June 16, 2015, K.E.L. and his family returned to the Mayo Clinic for a follow-up visit.
Ex. 8 at 66. At this time, the results of K.E.L.’s epiSEEK comprehensive epilepsy panel, which
assessed 471 genes implicated in pediatric epilepsy, were available. Id. Dr. Youssef noted that
there were multiple variants in three genes, but none of these specific genetic variants fit K.E.L.’s
clinic phenotype. Id. Parental genetic testing was suggested. Id.
Dr. Youssef also discussed K.E.L.’s treatment since he was last seen in the clinic. Ex. 8 at
65. Unfortunately, despite the higher doses of medication, K.E.L. was continuing to experience
epileptic spasms at a frequency of approximately three to five spasms per week. Id. at 65-66. The
week prior, K.E.L. experienced a cluster of approximately 13 spasms within ten minutes while in
the waiting room of a local ophthalmologist. Id. In terms of neurodevelopment, K.E.L. had not
experienced any neurodevelopmental plateau or regression over the last two months. Id. It was
noted that K.E.L.’s head circumference at this time had fallen to less than the third percentile by
June 16, 2015. Ex. 6 at 1-2.
During an exam conducted by Certified Nurse Practitioner Laura Vanbeek on July 5, 2015,
K.E.L. was noted to have trouble keeping his balance after starting a new seizure medication three
weeks prior. Ex. 3 at 12. The medical records documented that he had a possible ear infection and
instructed his parents to follow up with K.E.L.’s PCP if there was no improvement. Id. at 14.
On July 9, 2015, K.E.L.’s mother called Dr. Youssef at the Mayo Clinic to report that
earlier that morning, K.E.L. had experienced a new type of seizure. Ex. 8 at 62. She reported that
the seizure lasted three to four minutes with whole body stiffening, vocalizations, and that K.E.L.
seemed to be trying to stand up. Id. K.E.L.’s mother reported that her son had an ear infection for
which he was taking antibiotics. Id. After consultation, it was decided that there would be no
medication changes. Id.
On July 18, 2015, K.E.L. was taken to the ED after a 12-minute seizure. Ex. 8 at 44. K.E.L.
was with his family shopping when his mother reported that K.E.L. made a grunting noise and was
subsequently unresponsive. Id. Intermittently, his tone would return to normal, and he tried to
climb out of his stroller. Id. The family did not have any rescue medication with them at the time.
Id. K.E.L. was admitted for monitoring. Id. at 46. No seizure activity occurred during this
monitoring. Id. at 31. The EEG taken during this hospitalization did not show hypsarrhythmia. Id.
at 32. Changes to medication dosages were planned and Petitioners were counseled on the use of
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rescue medications. Id. at 33. K.E.L. remained hospitalized and was discharged on July 20, 2015.
Id. at 29.
On July 21, 2015, K.E.L. presented to Dr. Payne at the Mayo Epilepsy Clinic.9 Ex. 8 at 19.
Dr. Payne noted that K.E.L. had recently begun experiencing clusters of tonic spasms that included
guttural noises and lack of responsiveness during the episodes. Id. He noted that the spasms lasted
up to 13 minutes in length and had been increasing in frequency over the prior two months. Id.
K.E.L. had no clinical response to a new medication, Sabril, that had been administered to him at
full dose two weeks prior. Id. Dr. Payne noted that K.E.L. may have been “evolving from a West
syndrome phenotype towards a Lennox-Gastaut phenotype, although he has not met criteria for
that yet.” Id. at 19-20. Developmentally, it was noted that K.E.L. was making very slow gains. Id.
at 20. Dr. Payne noted that the etiology of K.E.L.’s epileptic encephalopathy had yet to be
determined. Id. No further genetic testing had been recommended at that time. Id. Dr. Payne
adjusted K.E.L.’s medications based on the perceived efficacy of the dosages and types of
medications in relation to K.E.L.’s seizure activity. Id. Petitioners were instructed to return with
K.E.L. in three months. Id.
On July 27, 2015, K.E.L. was evaluated by Dr. Kooima at the Avery McGreevy Clinic
after being hospitalized with croup the week prior. Ex. 3 at 6. K.E.L. was noted to have a “barky
sounding cough at night” and was “more listless than normal” but was otherwise in no acute
distress. Id. Petitioners were instructed to continue his medications as prescribed. Id.
On September 3, 2015, K.E.L., who was two years old at the time, presented to the ED
with a three-day history of diarrhea, fever, dehydration, and acute gastroenteritis symptoms. Ex. 2
at 125. He was admitted for treatment. Id. The treating physician noted that K.E.L. had been seizure
free for the past two weeks with additional Depakote therapy, but had a breakthrough seizure two
days prior. Id. at 130. The review of systems section of the record noted that K.E.L. “has been
walking and running up until this point in time. This is an improvement; his instability with gait is
improving with the adjunct of therapy. His speech is still a little delayed with just one word.” Id.
at 131. K.E.L. was treated and discharged the next day. Id. at 124-25; 131-33.
On September 4, 2015, K.E.L. underwent a scan of his abdomen after experiencing
diarrhea and fever. Ex. 2 at 31. The impression was “suspected colonic mural edema which could
be seen in colitis.” Id.
From September 2015 to August 2016, K.E.L. was seen in the ED several times for more
routine illnesses such as fevers, rash, ear infections, bronchitis, and pharyngitis. Ex. 2 at 203-49.
He continued to experience seizure activity during this time of varying severity and length. Id.
On November 7, 2016, K.E.L. presented for his three-year-old well child visit. Ex. 2 at
197. He was noted to be doing well with seizure control and had no seizures for the past three
months. Id. The medical records documented that K.E.L. had some behavioral issues since staring
preschool that week, as well as difficulty sleeping. Id. K.E.L. was noted to still have some
instability with his gait, was not spoon feeding, had no specific words, but was working on potty
training. Id. K.E.L. was described as a “very active child, biting new objects frequently.” Id. at
9 The record noted that Dr. Youssef had left the Mayo clinic. Ex. 8 at 19.
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198. The assessment included abnormalities such as low ferritin, acquired microcephaly,
developmental delay, seizure disorder, and insomnia due to medical condition. Id. at 200-01.
The most recently filed record is dated September 31, 2017, when K.E.L. was four years
old. Ex. 28 at 1. K.E.L. was noted to have global developmental delay including absent expressive
language and refractory epilepsy of unclear etiology. Id. The record states that his most recent
EEG, conducted in November 2016, showed right posterior discharges representing an
improvement. Id. At this appointment, the medical records describe that K.E.L. had no clear
seizure activity with his last definitive seizure one- and one-half years prior. Id. K.E.L. continued
to receive occupational therapy, physical therapy, and speech language therapy regularly. Id. He
only had a few expressive words at this time and his mother was concerned about his language
progress. Id. His health, otherwise, was noted to be good. Id.
III. Affidavits
A. Lisa Lindholm
Ms. Lindholm is K.E.L.’s mother. Ex. 4 at 1. Ms. Lindholm averred that her pregnancy
with K.E.L. was uncomplicated. K.E.L. was born via cesarean section due to previous cesarean
deliveries. Ms. Lindholm stated that K.E.L. was a “healthy little boy” from birth through February
26, 2014. She described that K.E.L. sat up, babbled, crawled and was a happy, playful child. Id.
Ms. Lindholm averred that K.E.L. received his routine vaccinations on October 28, 2013,
and December 23, 2013, without incident. Ex. 4 at 2. On February 26, 2014, K.E.L. received his
routine six-month vaccinations, including his third dose of the DTaP vaccine at the Brookings
Clinic. Id. She stated that on the evening of February 26, 2014, K.E.L. cried “uncontrollably” as
if any touch were painful to him. Id. Ms. Lindholm stated that toward the end of February 2014,
she noticed that K.E.L. was experiencing jerking spells, as if he was startled by something. Id.
Sometime prior to March 4, 2014, Ms. Lindholm noticed that K.E.L. was “behaving
lethargically and that he did not seem to even be present in his body.” Ex. 4 at 2. She stated that
K.E.L. appeared to not recognize his parents or other family members. Id. She stated that even
when there was a lot of activity around him, K.E.L. would stare off into space as if he did not
notice the activity around him. Id.
In her supplemental affidavit, Ms. Lindholm stated that she contacted K.E.L.’s
pediatrician, Dr. Eischens, to inquire about K.E.L.’s “abnormal jerking spells,” but was told that
his symptoms were likely just a result of pain from teething. Ex. 28 at 1. Ms. Lindholm stated
that she tried not to worry about K.E.L.’s jerking spells relying on this information. Id. Ms.
Lindholm acknowledged that Dr. Eischens’s records make no note of this telephone call and Ms.
Lindholm has no telephone records to confirm this call. Id.
Ms. Lindholm stated that in the beginning of April 2014, she began to notice that K.E.L.
was developmentally regressing in that he could no longer sit up on his own or attempt to crawl,
both of which he was doing prior to February 26, 2014. Ex. 4 at 2. He was no longer lifting his
head, or expressing any desire to eat, play or interact. Id. In her supplemental affidavit, Ms.
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Lindholm stated that she contacted Dr. Eischens on April 1, 2014, to express her concern, but
again, was told that it was likely just a response to teething. Ex. 27 at 1-2. When Ms. Lindholm
brought K.E.L. in to see Dr. Eischens the next day for a cough, she stated that Dr. Eischens again
failed to document the concerns about K.E.L.’s jerking spells. Id. at 2.
Ms. Lindholm described that K.E.L.’s issue with balance became apparent when he was
nine months old in May 2014. She stated that they attempted to have his photos taken, but he
would not sit up on his own, prompting the photographer to race over to prevent K.E.L. from
falling over. Ex. 4 at 2. Ms. Lindholm also noticed that K.E.L.’s “spells” were occurring more
often and involving more of his body. Id.
On June 14, 2014, Ms. Lindholm took K.E.L. to the ED when she noticed that he was
hardly moving. Ex. 4 at 2. She noted that K.E.L. was experiencing unusual lethargy and behavior.
Ms. Lindholm noted that even when K.E.L. was being examined and having blood drawn, he did
not react at all. Id. However, no cause for his behavior was identified. Id.
Ms. Lindholm described that she took K.E.L. to AMG Pediatric Specialists for a thorough
evaluation where he was diagnosed with infantile spasms. He was then admitted to the hospital
to begin a six-week course of ACTH therapy. Ex. 4 at 3. For a few months after beginning ACTH
therapy, K.E.L.’s spasms ceased. Id. While his EEG results continued to be abnormal, his seizure
activity had improved. Id.
On October 13, 2014, K.E.L. experienced a seizure that was longer and more severe than
prior seizures. Ex. 4 at 3. Ms. Lindholm reported that such seizures continued to happen
approximately twice per day for the next several months. Id. She stated that since that time, K.E.L.
has been examined by numerous doctors and specialists and has undergone a multitude of tests,
including genetic testing. However, no test has identified the cause of K.E.L.’s condition. Id.
Ms. Lindholm stated that she was advised by various physicians, including the
neurologists at the Minnesota Epilepsy Group, the doctors at the Mayo Clinic, and Dr. Falcao at
AMG Pediatric Specialists to cease further vaccinations for K.E.L. until the cause of his condition
had been identified. Ex. 4 at 3.
Ms. Lindholm stated that K.E.L. has been diagnosed with refractory epileptic spasms,
global developmental delay, and acquired encephalopathy. Ex. 4 at 3. He receives speech,
occupational, and physical therapy to address his developmental delays. Id. Ms. Lindholm stated
that although K.E.L. is being treated, she has been advised that it is unlikely that K.E.L. will ever
live independently. Id. at 4.
B. Erik Lindholm
Erik Lindholm is K.E.L.’s father. Ex. 5 at 1. He described K.E.L. as a “very happy, healthy
little boy” who enjoyed playing with his parents, as well as his older brother and sister. Id. Like
Ms. Lindholm, Mr. Lindholm described K.E.L. as inconsolable the evening of February 26, 2014,
and into the morning of February 27, 2014. Id.
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Mr. Lindholm stated that at the end of February 2014, he began to witness the “spells” that
his wife described K.E.L. was experiencing. Ex. 5 at 2. He stated that K.E.L. would begin jerking
or twitching as if something startled him. Id. Mr. Lindholm stated that he also began to notice that
K.E.L.’s behavior had changed. He was no longer happy and interactive but rather lethargic and
unreactive to the activity around him. Id.
Mr. Lindholm also discussed K.E.L.’s developmental regression. Ex. 5 at 2. Mr. Lindholm
stated that K.E.L. could no longer sit up by himself, crawl, or babble. Id.
Mr. Lindholm averred that in May 2014, K.E.L.’s spells worsened. Instead of a slight
jerking, K.E.L’s whole body was involved in the spasms, and that the spasms occurred more
frequently. Ex. 5 at 2. Mr. Lindholm acknowledged that the ACTH therapy seemed to work, but
that by October 13, 2014, the seizures returned.
Mr. Lindholm stated that K.E.L. has been diagnosed with epileptic spasms, global
developmental delay, and acquired microcephaly. Ex. 5 at 2. No cause has been identified for his
symptoms. Id.
C. Bonnie Lindholm
Bonnie Lindholm (“Bonnie”) is K.E.L.’s paternal grandmother. Ex. 19 at 1. Bonnie stated
that she had been very involved in K.E.L.’s life since his birth, including his treatment and care
following the February 26, 2014 DTaP vaccination. Id. Bonnie averred that from the time K.E.L.
was born through February 2014, her grandson was “very heathy and happy.” Id. She stated that
he was babbling, sitting up, and attempting to crawl.” Id. Bonnie stated that she noticed K.E.L.
experiencing his first “spell” on approximately March 2, 2014. Id. at 1-2. Two days later, she
noticed K.E.L. was lethargic and “no longer seemed to recognize me as he had previously…” Id.
at 2. She stated that she tried playing with her grandson, but he would stare blankly. Id. Bonnie
also stated that K.E.L. no longer attempted to crawl and had no interest in any of the activities he
had previously enjoyed. She recalled that in May 2014, for K.E.L.’s nine-month pictures, she and
Ms. Lindholm had to prop up K.E.L. for the photo because he could not support himself. Id. Bonnie
stated that she was present for K.E.L.’s evaluation at the Mayo Clinic in April 2015. Id. She stated
that when she asked about K.E.L.’s prognosis, she was told that K.E.L. would most likely never
be able to live independently. Id.
D. Misty Alfson
Misty Alfson (“Ms. Alfson”) is K.E.L.’s aunt. Ex. 20 at 1. Ms. Alfson stated that from birth
through February 2014, K.E.L. was a “generally healthy little boy…. he was generally happy,
playful, and interactive.” Id. She recalled that in the weeks following the February 2014
vaccinations, she observed that K.E.L. was different; that he had regressed in his development and
no longer seemed interested in playing or interacting. Id. She described several incidents where
K.E.L. seemed uninterested and unresponsive to her and her family members. Id. at 1-2. Ms.
Alfson stated that she drove Petitioners and K.E.L. to several appointments at the Minnesota
Epilepsy Group and was present during the evaluations. Id. at 2. She stated that she asked many
questions about the possible causes for K.E.L.’s seizure disorder and whether the vaccinations
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were a possible cause. Id. While she stated that the physicians told her that the vaccinations were
an unlikely cause, the doctors did instruct Petitioners to hold off on obtaining any further
vaccinations for K.E.L. until the cause of his condition had been determined. Id.
E. Danielle Eppe
Danielle Eppe (“Ms. Eppe”) is another of K.E.L.’s aunts. Ex. 21. In her affidavit, she stated
that she and her family lived approximately one hour away from K.E.L. and Petitioners’ home. Id.
Ms. Eppe stated that around Christmas 2013, she recalled interacting with K.E.L. and having him
make eye contact with her and smile. Id. On February 22, 2014, her father’s birthday, she recalled
seeing Petitioners and K.E.L. at a baseball game. Id. She stated that she fed K.E.L. with a bottle
and again recalled making eye contact with him and observing him play with toys. Id. However in
March or April 2014, she stated that she babysat for K.E.L. and noticed that his behavior was “very
different.” Id. at 2. Specifically, she stated that K.E.L. would not interact or respond to her, and he
seemed very lethargic. Id. Again on April 20, 2014, when celebrating Easter, Ms. Eppe noticed
that K.E.L. hardly seemed to notice her and would not interact or play. Id.
IV. Expert Opinions and Qualifications
A. Petitioners’ Expert: Dr. L. Douglas Wilkerson, M.D.
1. Qualifications
Dr. Wilkerson received his medical degree from Emory University in Atlanta, Georgia,
in 1969. ECF No. 32 (2) at 1 (hereinafter “Wilkerson CV”). Dr. Wilkerson completed his post-
doctoral training in psychiatry and neurology (with a special competency in child neurology) and
is board certified in pediatrics. Wilkerson CV at 1. Dr. Wilkerson has held a number of hospital
and academic appointments. Id. at 1-2. He taught at the University of Pennsylvania School of
Medicine in both the Department of Neurology and the Department of Pediatrics for 15 years.
ECF No 36 (3); Fees App.; Ex. 2. Additionally, Dr. Wilkerson has been a pediatric neurologist at
Bryn Mawr Hospital for nearly 40 years and has served as the Director of the Department of
Pediatrics at the hospital from 1992-1998. Id. He is a member of numerous professional societies,
including the American Academy of Neurology, the Child Neurology Society, the American
Epilepsy Society, and the American Academy of Pediatrics as a fellow. Id. at 2-3. Dr. Wilkerson
has published several original articles, reviews and chapters regarding pediatrics and neurology.
See id. at 3.
2. Expert Reports
a. First Wilkerson Report
In Dr. Wilkerson’s initial report, he opined that there are three “fundamental statements in
this case which are straightforward and well supported by the evidence in this file.” First Wilkerson
Rep. at 1. First, he stated that K.E.L. was taken to a local neurologist because of jerking spells and
was found to have infantile spasms “associated with the classic EEG abnormality of
hypsarrhythmia.” Id. Second, K.E.L. had a brief remission of his seizure disorder in response to
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treatment, but which evolved to probable Lennox-Gastaut Syndrome. Dr. Wilkerson also noted
that K.E.L.’s development slowed and his “previously normal head circumference trajectory has
likewise slowed so that he now is microcephalic” Id. And third, K.E.L. received his routine
immunizations on schedule “with a third administration of DTaP vaccine in late February, a bit
less than four months before his initial presentation to the local neurologist because of jerking
spells.” Id. at 1-3. Dr. Wilkerson also observed that most known causes for K.E.L.’s seizures and
microcephaly had been eliminated during the Mayo Clinic evaluation and subsequent testing. Id.
at 3. Dr. Wilkerson opined:
Since the findings of that evaluation eliminate all currently known alternative
causes other than that of vaccine injury as the basis of the encephalopathy manifest
in K.E.L., the results of that evaluation are consistent with the hypothesis of
vaccine-related brain injury as its cause but, absent a consensus accepted biologic
marker of vaccine-related brain injury, the hypothesis of vaccine-related brain
injury was not scientifically proven. In other words, although it will never be
scientifically proven that vaccine administration has caused brain injury in any
individual until a biologic marker of that is eventually established, nevertheless, at
this moment in time, the elimination of all other known causes of an
encephalopathy than that of vaccine injury means that, more likely than not,
vaccine-related brain injury is the cause of the encephalopathy manifest in K.E.L.
Stated differently, from the medical standpoint of review of this file, it is apparent
that, but for the administration of routine infantile vaccine in late February 2014,
K.E.L. otherwise would not have developed infantile spasms and its associated
encephalopathy.
Id.
Dr. Wilkerson went on to explain the difference between “typical” seizures and infantile
spasms, noting that pinpointing the onset of the latter is exceedingly difficult due to the subtle and
fleeting movements that are seizures, but not recognized as such. Id. at 4-5. Dr. Wilkerson
described how with typical seizures, onset is easy to recognize as the first event is often a dramatic
event comprised of a sudden loss of consciousness with body stiffening, convulsive jerking lasting
for one to several minutes, and followed by a lengthy period of exhaustion and disorientation which
is often referred to as the postictal state. Id. at 4. With infantile spasms, Dr. Wilkerson explained
that “the individual seizures are fleeting in duration and, especially at the onset, often very subtle,
at times producing only a nod of the head or barely perceptible jerk or movement of the shoulders,
trunk or hips.” Id. In addition, Dr. Wilkerson noted that seizure activity often occurs during sleep
or during the time between sleep and waking when there is less observation of the child. Thus, the
onset of seizures could be occurring, but unwitnessed. Dr. Wilkerson also noted that because
infantile spasms are so rare, much more rare than “typical” seizures, “we virtually never hear the
story of infantile spasms having a well delineated, clearly perceived onset that is comparable to
the story told with ‘typical’ seizures…” Id. at 6. Thus, Dr. Wilkerson posited “an approximation
of onset of K.E.L.’s spasms and behavioral changes within the week or so after the time of
immunization … is a close fit with the NVICP criteria as can be expected.” Id.
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Dr. Wilkerson also explained that the recognition of an encephalopathy might not be
evident until the child progressed far enough in development to recognize delays in reaching
milestones. First Wilkerson Rep. at 7. For example, if an infant were unable to stand or walk at 10
to 14 months, recognition of a problem may occur, but the encephalopathy “would have been
silently present long before.” Id. Dr. Wilkerson noted that the same concept also applies to
microcephaly, when by the time of the microcephaly is observed, the progression has occurred
long before. Id.
Dr. Wilkerson next discussed “primitive responses” noting that normal primitive responses
typically extinguish in infants at a point prior to those in K.E.L. Id. at 7. Given this clinical picture,
Dr. Wilkerson posited that K.E.L.’s encephalopathy occurred at approximately six months of age.
Id.
Dr. Wilkerson’s conclusions at the end of report are that: (1) K.E.L. was normal at birth
and for the first six months of his life; (2) at 10 months of age, K.E.L. was diagnosed with infantile
spasms and that these spasms began, more likely than not, at about six months of age; (3) the
diagnosis of infantile spasms occurred much later than the noted onset of symptoms described in
the medical records; (4) the outcome of K.E.L.’s disorder has been poor; (5) there is a lack of
information in the medical records that can pinpoint the onset of K.E.L.’s disorder; (6) no cause
was identified for K.E.L.’s infantile spasms despite the thoroughness of testing; (7) there is a timely
and causal link between the onset of K.E.L.’s spasms and the DTaP vaccine, particularly the
pertussis component; (8) “there was a timely and causal linkage between the onset of the
encephalopathy at approximately six months of age and vaccination; and (9) the preponderance of
evidence at the level of current scientific understanding, as Dr. Wilkerson understands it, supports
the medical conclusion that
more likely than not, there is a significant causal contribution to the encephalopathy
present in K.E.L. which is attributable to the immediate proximate vaccine
administered to him in late February 2014. Stated differently, more likely than not,
but for the vaccine administration of February 2014, K.E.L. otherwise would not
have developed infantile spasms or the related encephalopathy.
Id. at 9.
b. Second Wilkerson Report
In Dr. Wilkerson’s second report (“Second Wilkerson Rep.”), prepared after Respondent’s
expert’s report was filed (prepared by Dr. Kohrman), Dr. Wilkerson disagreed with Dr. Kohrman’s
conclusion that K.E.L. had progressive microcephaly with the onset occurring at two months of
age, and therefore concluding that the DTaP vaccination could not have caused his microcephaly
or infantile spasms. Second Wilkerson Rep. at 1. Dr. Wilkerson explained that “measurement of
head circumference is difficult and subject to both interobserver variance and single observe
inconsistency, owing to the inherent difficulty of measuring the longest circumference of an egg-
shaped object and particularly so under the circumstances…” Id. He stated that because head
circumference is typically measured by different staff members at different visits, that the
likelihood of interobserver variance is great. Id. at 1-2. As a result, he opined that there is
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“legitimate uncertainty about the start of the abnormal trajectory leading eventually to the
microcephalic range.” Id. at 2.
Dr. Wilkerson explained that abnormally small head circumference is generally a result of
abnormal brain development. However, with K.E.L., Dr. Wilkerson noted that there were no
developmental abnormalities until approximately eight or nine months of age (“[t]he first
medically recorded note of neurodevelopmental abnormality was the report of persisting neonatal
responses described when K.E.L. was around eight- or nine-months age”). Id. at 2. At this time,
there was a description of persisting neonatal primitive responses, which Dr. Wilkerson stated
should have diminished around age two or three months. Id.
Next, Dr. Wilkerson observed that no specific cause was identified for K.E.L.’s condition,
allowing a vaccine-induced encephalopathy to remain as a possible cause. Id. Dr. Wilkerson
reiterated his conclusions that “K.E.L. has a severe encephalopathic process with onset at point
proximate to his age of 6 months and that the administration of his third vaccine dose of the DTaP”
and thus, he fulfills the requirements for compensation under the Vaccine Act. Id. at 4.
B. Respondent’s Expert – Dr. Michael Kohrman
1. Qualifications
Dr. Michael H. Kohrman received a combined Bachelor of Science degree and Master of
Science degree in chemistry from Stanford University in 1977. Ex. B (hereinafter “Kohrman CV”
at 2). He graduated from Rush Medical College in 1981 with a degree in medicine. Id. From 1981
through 1983, Dr. Kohrman served as an intern, then a resident in pediatrics at the University of
Chicago Hospitals and Clinics. Id. He also trained in a fellowship for pediatric neurology at the
University of Chicago Hospitals and Clinic from 1983 through 1986. Id. Additionally, Dr.
Kohrman trained in a fellowship for electroencephalography at the University of Illinois from 1986
to 1987. Id. He is board-certified in neurology, with a special competency in child neurology and
sleep medicine and is also board-certified in pediatrics. Id. at 4. Currently, Dr. Kohrman serves as
the Director of Child Neurology at Akron Children’s Hospital and Professor of Pediatrics at
Northeastern Ohio Medical University. Ex. A at 1. He previously directed the Epilepsy Program
at Comer Children’s Hospital at the University of Chicago and was Professor of Pediatric
Neurology and Surgery. Id. He has been an attending physician providing care to children with
epilepsy for over 30 years. Id. Dr. Kohrman has treated over 100 children with infantile spasms
and thousands of children with epilepsy. Id. His current responsibilities are 80% clinical and 20%
administrative. He attends on the Epilepsy service at Akron hospital 18 weeks per year and the
focus of his practice is epilepsy (95%) and sleep medicine (5%). Dr. Kohrman has published more
than 100 book chapters, professional abstracts, presentations, and papers. Kohrman CV at 2–17.
2. Expert Report
Dr. Kohrman submitted three expert reports in this case. Ex. A (hereinafter “First Kohrman
Rep.”), Ex. C (hereinafter “Second Kohrman Rep.”), and Ex. D., (hereinafter “Third Kohrman
Rep.”).
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a. First Kohrman Report
In his initial expert report, Dr. Kohrman observed that K.E.L.’s head circumference
measurements decreased from the time of his birth to the date of his third DTaP vaccination. First
Kohrman Rep. at 1-2. Specifically, Dr. Kohrman noted that K.E.L.’s head circumference was
recorded at the 8th percentile on February 26, 2014, the date of his 3rd DTaP vaccine. Id. at 2.
Dr. Kohrman next provided a background summary on infantile spasms. First Kohrman
Rep. at 5-6. He cited to an article written by Pavone, et al., that explains infantile spasms are an
age-related disorder, and represent the most frequent type of epilepsy in the first year of life. Id. at
6. Pavone et al. described that the peak of infantile spasms occur between four and seven months,
with 85% of the spasms ceasing before the age of five. Id. The clinical features of spasms include
brief contractions, jerking, deviation of the eyes, and changes in respiratory patterns. Id.
Developmental delay associated with infantile spasms is usually severe, although some patients
have preserved cognitive profiles. Id. The etiology of infantile spasms remains elusive in some
cases. Some noted causes of infantile spasms are hypoxic-ischemic encephalopathy (10%),
chromosomal anomalies (8%), malformation (8%), perinatal stroke (8%), tuberous sclerosis
complex (7%), and periventricular leukomalacia or hemorrhage (5%). Id. Dr. Kohrman noted that
K.E.L. fits into a group with genotype unknown with progressive microcephaly noted early in life.
Id.
In his assessment of K.E.L.’s case, Dr. Kohrman opined that K.E.L. had progressive
microcephaly which predated all of his DTaP vaccinations, and thus, there is no evidence to
suggest that his vaccinations changed the course of his disorder. First Kohrman Rep. at 8. He
discussed Dr. Wilkerson’s opinion that because no underlying cause was identified for K.E.L.’s
infantile spasms, that vaccination must be the cause. Dr. Kohrman noted that in children with
infantile spasms, only 64% had an identified underlying cause, meaning 36% of the children had
no cause identified, like K.E.L. Id. at 9.
Dr. Kohrman also cited to the Institute of Medicine study that reviewed the question of a
link between the DTaP vaccine and infantile spasms, noting that any association between the two
was lacking. First Kohrman Rep. at 9. Dr. Kohrman concluded that based on the medical records,
“there is no evidence that the DTaP [vaccine] caused [K.E.L.’s] microcephaly and seizure disorder
and that the underlying progressive microcephaly predates vaccination as documented in the head
circumference charts.” Id.
b. Second Kohrman Report
In Dr. Kohrman’s second report, responding to Dr. Wilkerson’s supplemental report, he
opined that K.E.L.’s head circumference measurements at birth and eight days later were
essentially the same and would confirm the measurement as accurate. Second Kohrman Rep.at 2.
He pointed out that the two-month head circumference measurement would require a very large
measurement error, an entire two centimeters, to be at the 50% percentile, as the first two
measurements were, thus inferring that the measurement was accurate and confirmed the onset
of K.E.L.’s microcephaly prior to vaccination. Id.
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Dr. Kohrman agreed with Dr. Wilkerson that skull growth is dependent on brain growth.
Second Kohrman Rep. at 2. However, Dr. Kohrman stated that this fact supports the concept that
K.E.L. had a preexisting brain disorder that caused his infantile spasms diagnosis. Id. Thus,
K.E.L.’s progressive microcephaly confirms a process that was the cause of K.E.L.’s infantile
spasms. Id.
Dr. Kohrman stated the medical literature demonstrates there is no specific correlation
between the timing of the event that causes spasms, here microcephaly, and the actual onset of
the spasms. Second Kohrman Rep. at 3. He pointed this out to refute Dr. Wilkerson’s claim that
a temporal association between K.E.L.’s third DTaP vaccine and the onset of his spasms
established causation. Id. Citing to Guggenheim et al., Dr. Kohrman described a study where 19
published cases were identified to determine whether there was any such correlation. Id. at 3. The
findings of the study refuted “claims that a close temporal association between an immunization
and the onset of infantile spasms establishes causation.” Id. at 4. Thus, Dr. Kohrman reiterated
his conclusion that there is no evidence that the DTaP vaccine caused K.E.L.’s microcephaly and
seizure disorder, and that the underlying progressive microcephaly predated K.E.L.’s third DTaP
vaccination as documented in the head circumference charts. Id.
b. Third Kohrman Report
Dr. Kohrman filed a third expert report (Ex. D.) in response to questions I posed. My questions
were as follows:
(1) Petitioners have alleged (among other injuries) that K.E.L. experienced an encephalopathy
within 72 hours of the DTaP vaccine. Encephalopathy within 72 hours of vaccines
containing DTaP is a Table injury. Dr. Wilkerson stated, “My conclusion is that the
encephalopathy described in K.E.L. had onset at about six months.” First Wilkerson Rep.
at 7. He further opined that “the sum of evidence in this case is that, more likely than not,
the insidious onset of his disorder, as best can be approximated, fell within a span of around
three days, or seventy-two hours following the receipt of standard infantile immunization.”
Id. at 8. Please provide your opinion as to whether K.E.L. experienced an encephalopathy
and if he did, when the encephalopathy began. Please also address whether that timing is
or is not consistent with a vaccine reaction.
(2) Dr. Wilkerson discussed primitive reflexes that K.E.L. exhibited during an examination on
June 14, 2014 (referencing Ex. 2 at 92). Dr. Ellsworth noted that K.E.L. exhibited “normal
primitive reflexes.” Dr. Wilkerson stated, “Primitive responses extinguish in
developmentally normal infants at a point several months earlier than K.E.L. was at that
point so that the presence of primitive responses at his then-current age was highly
abnormal and indicative of an encephalopathy.” First Wilkerson Rep. at 7. Do you agree
with Dr. Wilkerson’s position?
(3) Is there an association between microencephaly and infantile spasms?
With respect to the first question, whether K.E.L. experienced an encephalopathy within
72 hours of his third DTaP vaccine on February 26, 2014, Dr. Kohrman responded by summarizing
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the well-child visits during this examination, as well as K.E.L.’s nine-month well-child visit. Third
Kohrman Rep. at 1. At the six-month well-child visit, Dr. Kohrman observed that K.E.L.’s
development was reported as normal – rolling, babbling, and sitting for a brief period. Id. At this
time, K.E.L.’s head circumference had already dropped to the 8th percentile, although his weight
was at the 40th percentile. Id. During the nine-month well child examination, K.E.L.’s development
was likewise reported as normal – he was crawling, and saying “mama” and “dada”, as well as
standing with support transfers from hand to hand. Id. During the nine-month examination,
K.E.L.’s head circumference measurement had further dropped to the third percentile, while his
weight remained in the 40th percentile. Id. at 1-2. Dr. Kohrman opined as follows:
His head circumference growth is the direct result of brain growth and this lack of
head growth is consistent with abnormal brain development as the underlying cause
of his Infantile spasms which began prior to vaccinations in question. K.E.L’s
developmental regression coincides with the onset of his infantile spasms. This is
consistent with an epileptic encephalopathy caused by infantile spams which did
not occur within 72 hrs of vaccination.
Id. at 3.
Dr. Kohrman stated that as defined by the vaccine injury table, “[a]n acute encephalopathy
for acute encephalopathy for children less than 18 months of age who present without a seizure is
indicated by a significantly decreased level of consciousness that lasts at least 24 hours. Following
a seizure, an acute encephalopathy is demonstrated by a significantly decreased level of
consciousness that lasts at least 24 hours and cannot be attributed to a postictal state—from a
seizure or a medication.” Third Kohrman Rep. at 2. Dr. Kohrman stated that the reports made by
K.E.L.’s family – sleepiness, irritability (fussiness), high-pitched and unusual screaming, poor
feeding, persistent inconsolable crying, etc., as well as seizures in and of themselves, are not
sufficient to constitute a diagnosis of encephalopathy, either acute or chronic. Id. He opined that
based on the medical records, “there is no evidence for an acute encephalopathy after vaccination
on 2/26/2014 nor a chronic encephalopathy in the 3 months prior to onset of infantile spasms in
June of 2014.” Id.
Regarding Dr. Wilkerson’s comments on primitive responses, he stated that Dr. Wilkerson
misinterpreted the ER notation in the medical records. Third Kohrman Rep. at 2. The note from
the ER visit indicated K.E.L. had “normal primitive reflexes for age”. Dr. Kohrman opined that
the more accurately worded notation would have been “no primitive reflexes” or “none.” Id. Dr.
Kohrman stated that this is the likely intention of the note as there were not primitive reflexes
observed during K.E.L.’s six- and nine-month well-child visits. Id. In addition, there were no
primitive reflexes noted by the neurologist who admitted K.E.L. for treatment of his infantile
spasms. Id. Essentially, there is nothing in the record to support Dr. Wilkerson’s interpretation of
the note of “normal primitive reflexes for age.” Id.
Dr. Kohrman did not answer my third question as to whether there is any association
between microcephaly and infantile spasms. I note that in his initial report, Dr. Kohrman did state
that K.E.L.’s “record demonstrates that he had progressive loss in head circumference
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[microcephaly] from birth the etiology of which is unknown and is the etiology of his spasms.”
First Kohrman Rep. at 9.
V. Applicable Law
A. Petitioner’s Burden in Vaccine Program Cases
Under the Vaccine Act, when a petitioner suffers an alleged injury that is not listed in the
Vaccine Injury Table, a petitioner may demonstrate that he suffered an “off-Table” injury.
§ 11(c)(1)(C)(ii).
In attempting to establish entitlement to a Vaccine Program award of compensation for an
off-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit
in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen requires that
petitioner establish by preponderant evidence that the vaccination he received caused his injury
“by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a
showing of a proximate temporal relationship between vaccination and injury.” Id. at 1278.
Under the first prong of Althen, petitioners must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford v. Sec.’y of
Health & Hum. Servs., 451 F.3d 1352,1355-56 (Fed. Cir. 2006) (citations omitted). To satisfy this
prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific
explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Proof
that the proffered medical theory is reasonable, plausible, or possible does not satisfy a petitioner’s
burden. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. Nov. 7,
2019).
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). However, special masters are “entitled to require some indicia
of reliability to support the assertion of the expert witness.” Boatmon, 941 F.3d at 1360, quoting
Moberly, 592 F.3d at 1324. Special Masters, despite their expertise, are not empowered by statute
to conclusively resolve what are complex scientific and medical questions, and thus scientific
evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian,
but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at
1380. Accordingly, special masters must take care not to increase the burden placed on petitioners
in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of Health & Hum.
Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017);
see also Hock v. Sec’y of Health & Hum. Servs., No. 17-168V, 2020 U.S. Claims LEXIS 2202 at
*52 (Fed. Cl. Spec. Mstr. Sept. 30, 2020).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion
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testimony are favored in vaccine cases, as treating physicians are likely to be in the best position
to determine whether a ‘logical sequence of cause-and-effect show[s] that the vaccination was the
reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed
as particularly trustworthy evidence, since they are created contemporaneously with the treatment
of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”). As with expert testimony offered to establish a theory of causation, the opinions, or
diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions
or bases. The views of treating physicians should also be weighed against other, contrary evidence
also present in the record. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011),
aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health & Hum. Servs., No. 06-522V, 2011
WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344,
356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012),
aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-
355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl.
Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
In determining whether a petitioner is entitled to compensation, a special master must
consider the entire record and is not bound by any particular piece of evidence. § 13(b)(1) (stating
that a special master is not bound by any “diagnosis, conclusion, judgment, test result, report, or
summary” contained in the record). Furthermore, a petitioner is not required to present medical
literature or epidemiological evidence to establish any Althen prong. The special master essentially
must weigh and evaluate opposing evidence in deciding whether a petitioner has met their burden
of proof. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009); see also
Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1149 (Fed. Cir. 1992).
B. Law Governing Analysis of Fact Evidence
The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).
The special master is required to consider “all [] relevant medical and scientific evidence contained
in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s
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report which is contained in the record regarding the nature, causation, and aggravation of the
petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic
or evaluative test which are contained in the record and the summaries and conclusions.” Section
13(b)(1)(A). The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3
F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to
afford greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).
Medical records created contemporaneously with the events they describe are generally
trustworthy because they “contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v.
Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528.
This presumption is based on the linked proposition that (i) sick people visit medical professionals;
(ii) sick people honestly report their health problems to those professionals; and (iii) medical
professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 at *2 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013) mot. for rev. denied, 142 Fed. Cl. 247, 251-52 (2019), vacated on
other grounds and remanded, 809 Fed. Appx. 843 (Fed. Cir. Apr. 7, 2020).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL
6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are generally found to be deserving of greater evidentiary weight than oral testimony -- especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony
which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)).
However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent and
compelling.” Sanchez, 2013 WL 1880825 at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
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No. 90-2808V, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires petitioners to present expert testimony in support of their claim. Lampe v. Sec’y of Health
& Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually
evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell
Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs.,
617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d
1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony are:
(1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique
has been subjected to peer review and publication; (3) whether there is a known or potential rate
of error and whether there are standards for controlling the error; and (4) whether the theory or
technique enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at
1316 n.2 (citing Daubert, 509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora. Daubert factors are employed by judges to exclude
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”).
Respondent frequently offers one or more experts of his own in order to rebut petitioners’
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a
particular expert’s credibility, is part of the overall reliability analysis to which special masters
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must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”).
D. Consideration of Medical Literature
Although this decision discusses some but not all of the medical literature in detail, I
reviewed and considered all of the medical records and literature submitted in this matter. See
Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally
presume that a special master considered the relevant record evidence even though [s]he does not
explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health & Hum. Servs.,
115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every piece of
evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed. Cir.
2015).
V. Analysis
A. Dismissal for Failure to Prosecute and Failure to Follow Court Orders
Vaccine Rule 21(b)(1) provides that a “special master or the court may dismiss a petition
or any claim therein for failure of the petitioner to prosecute or comply with these rules or any
order of the special master or the court.” Failure to follow court orders, as well as failure to file
status reports or other required documents, can result in dismissal of petitioner’s claim. Tsekouras
v. Sec’y of Health & Hum. Servs., 26 Cl. Ct. 439 (1992), aff’d per curiam, 991 F.2d 810 (Fed. Cir.
1993); Sapharas v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 503 (1996); Vaccine Rule 21(b).
Petitioners have not communicated with my chambers since January 31, 2022, despite
numerous orders to do so and a show cause order, notifying them that their case would be dismissed
if they did not respond. While I could dismiss their case on this basis alone, I have conducted a
substantive analysis, detailed below.
B. Resolution of Case Without a Hearing
Because Petitioners stopped communicating with my chambers, I have opted to determine
entitlement in this case based on evidentiary filings, including the medical records, the affidavits,
and the expert reports and medical literature filed by each side. The Vaccine Act and Rules not
only contemplate but encourage special masters to decide petitions on papers rather than via
evidentiary hearing, when they conclude that the former means of adjudication will properly and
fairly resolve the case. § 12(d)(2)(D); Vaccine Rule 8(d). The choice to do so has been affirmed
on appeal. See Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided
on the papers in lieu of a hearing). A hearing is not required in every matter, regardless of the
parties' preferences. See Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 400-01 (1997)
(determining that the special master acted within his discretion in denying evidentiary hearing),
appeal dismissed, 135 F.3d 773 (Fed. Cir. 1997); Burns v. Sec’y of Health & Hum. Servs., 3 F.3d
415, 417 (Fed. Cir. 1993); Murphy v. Sec’y of Health & Hum. Servs., No. 90-882V, 1991 WL
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71500, at *2 (Ct. Cl. Spec. Mstr. Apr. 19, 1991), mot. for rev. denied, 23 Cl. Ct. 726 (1991), aff'd,
968 F.2d 1226 (Fed. Cir. 1992).
A hearing provides a petitioner with the opportunity to present live testimony, which aids
the special master most in cases where witness credibility is at issue, or where there is a need to
pose questions to a witness in order to obtain information not contained in, or not self-evident
from, the existing filings. See, e.g., Hooker, 2016 WL 3456435, at *21 (discussing the factors that
weigh against holding a hearing); Murphy, 1991 WL 71500, at *2 (finding no justification for a
hearing where “the claim is fully developed in the written record and the special master sees no
need to observe the fact witnesses personally for the purpose of assessing credibility). Prior
decisions have recognized that a special master’s discretion in deciding whether to conduct an
evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to afford each party “a full
and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 401. But that rule also includes the
obligation to create a record “sufficient to allow review of the special master's decision.” Id. Thus,
the fact that a claim is legitimately disputed, such that the special master must exercise her
intellectual faculties in order to decide a matter, is not itself grounds for a trial. Special masters are
expressly empowered to resolve fact disputes without a hearing, and they may do so if the record
at issue has been sufficiently developed to determine that each side's “full and fair” opportunity
has not been abridged.
In this case, live witness testimony was not required in order for me to reach a reasoned
decision on entitlement. The record itself contained sufficient evidence upon which to base this
decision. The flaws in Petitioners’ theory and factual arguments were self-evident from review of
the medical records and the expert reports submitted, which relied heavily on speculative
assertions and statements unsupported by the contemporaneous medical record or by reliable
scientific evidence. I simply do not require additional oral testimony to decide the case. Ultimately,
the most significant issue in deciding whether to hold a hearing is whether the refusal to do so will
deprive the claimants of the fair opportunity to prosecute their case. Petitioners have received such
an opportunity here. Therefore, these circumstances counsel in favor of resolving the matter on the
papers.
C. Table Claim
In a Table encephalopathy claim, Petitioners must first demonstrate that K.E.L. received a
covered vaccine. Next, Petitioners must demonstrate that K.E.L. suffered an injury corresponding
to the covered vaccine within the specified time period. Here, the Table lists an encephalopathy as
an injury arising from the DTaP vaccine if the injury occurs within three days of the vaccination.
See 42 C.F.R. § 100.3(a). The definition of encephalopathy under the Vaccine Table is a narrower
interpretation than what is commonly accepted in the medical community. Under the
Qualifications and Aids to Interpretation (“QAI”) of the Vaccine Table, a Table encephalopathy
occurs where the vaccinee suffers an acute encephalopathy, followed by a chronic encephalopathy
for more than six months, or death. 42 C.F.R. § 100.3(a)-(b)(2).
Petitioners allege that K.E.L. suffered from the Table injury, encephalopathy within 24
hours of receiving his third DTaP vaccine. The QAI defines “acute encephalopathy” as “one that
is sufficiently severe so as to require hospitalization (whether or not hospitalization occurred.) 42
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C.F.R. § 100.3(b)(2)(i). For children who are less than 18 months of age, which includes K.E.L.,
“an acute encephalopathy is indicated by a significantly decreased level of consciousness lasting
for at least 24 hours.” 42 C.F.R. § 100.3(b)(2)(i)(A). The definition of the phrase “significantly
decreased level of consciousness” is found in paragraph D, which states:
A “significantly decreased level of consciousness” is indicated by at least one of the
following clinical signs for at least 24 hours or greater (see paragraphs (2)(i)(A) and
(2)(i)(B) of this section for applicable time frames.
(1) Decreased or absent response to environment (response, if at all, only to loud voice
or painful stimuli);
(2) Decreased or absent eye contact (does not fix gaze upon family members or other
individuals); or
(3) Inconsistent or absent responses to external stimuli (does not recognize familiar
people or things.)
42 C.F.R. § 100.3(b)(2)(i)(D); see also Waddell, 2012 WL 4829291, at 7 (holding that the QAI
definition of “significantly decreased level of consciousness” implies “a state of diminished
alertness that is much more than mere sleepiness or inattentiveness...[It] requires markedly
impaired – or strikingly absent – responsiveness to environmental or external stimuli for a
sustained period of at least twenty-four hours.”)
The following have been excluded as features that demonstrate an encephalopathy.
The following clinical features alone, or in combination, do not demonstrate an
acute encephalopathy or a significant change in either mental status or level of
consciousness as described above: Sleepiness, irritability (fussiness), high-pitched
and unusual screaming, persistent inconsolable crying and bulging fontanelle.
Seizures in themselves are not sufficient to constitute a diagnosis of
encephalopathy. In the absence of other evidence of an acute encephalopathy,
seizures shall not be viewed as the first symptom or manifestation of the onset of
an acute encephalopathy.
42 C.F.R. § 100.3(b)(2)(i)( E), see also Watt v. Sec’y. of Health & Hum. Servs. No. 99–25V, 2001
WL 166636, at 8 (Fed. Cl. Spec. Mstr. Jan. 26, 2001) (explaining that a Table encephalopathy
“cannot merely be crying” and “it cannot merely be crankiness”).
I note again that the QAI specifically exclude the presence of seizures as evidence of an
acute encephalopathy: “Seizures in themselves are not sufficient to constitute a diagnosis of
encephalopathy and in the absence of other evidence of an acute encephalopathy, seizures shall
not be viewed as the first symptom or manifestation of an acute encephalopathy.” 42 C.F.R. §
100.3(b)(2)(i)(D).
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Petitioners allege that K.E.L.’s claim should be considered a Table injury, arguing that the
third DTaP vaccine administered to K.E.L. on February 26, 2014, caused encephalopathy.
Petitioners appear to allege that K.E.L.’s presentation of “uncontrollable” crying, jerking spells,
startling, and painful responses that occurred “in the last few days of February” are manifestations
of the onset of his Table encephalopathy. Petition at 2; Ex. 4 at 2 (Lisa Lindholm affidavit); Ex. 5
at 1-2 (Erik Lindholm affidavit). In the post 72-hour period, approximately March 4, 2014,
Petitioners allege that K.E.L. acted lethargically, absent-mindedly, and seemed not to notice or
recognize his parents or siblings. Petition at 2, ¶ 4; Ex. 4 at ; Ex. 28 at 1 (Lisa Lindholm Supp.
Aff.).
Unfortunately, Petitioners’ expert, Dr. Wilkerson, did little to clarify which behaviors
K.E.L. exhibited in the 72 hours after vaccination that constitute the onset of an acute
encephalopathy. Rather, Dr. Wilkerson acknowledged that the behaviors constituting the onset of
encephalopathy are “too vague and subtle to be initially perceived as abnormal by parents.” First
Wilkerson Rep. at 6. Dr. Wilkerson simply posited that “an approximation of onset of K.E.L.’s
spasms and behavior changes within the week or so after the time of immunization, as described
in the petitioner’s affidavit, is as close a fit with the NVICP criteria as can be reasonably expected
…” Id.
Respondent’s expert, Dr. Kohrman, stated that “the symptoms of K.E.L.’s epileptic
encephalopathy are noted in the medical record to begin in May to June of 2014, two months after
his third DTaP vaccination.” First Kohrman Rep. at 8. An epileptic encephalopathy is not an acute
encephalopathy as defined by the Table. Even if it were, Dr. Kohrman opined that the onset of the
disorder began in May or June 2014, approximately two months after vaccination. Id.
Ultimately, the evidence does not demonstrate that K.E.L. suffered a Table
encephalopathy. As former Chief Special Master Campbell-Smith noted in Waddell v. Sec’y of
Health & Hum. Servs., the symptoms of a Table encephalopathy are “neither subtle nor insidious.”
No. 10-316V, 2012 WL 4829291, at *6 (Fed. Cl. Spec. Mstr. Sept. 19, 2012). In reviewing and
evaluating all of the behaviors and symptoms that K.E.L. exhibited in the 72 hours post
vaccination, including all information reported in the medical records, the witness affidavits, and
the information contained in the parties’ respective expert reports, it is apparent that none of these
behaviors constitute an acute encephalopathy as defined by the Vaccine Table. In fact, the
particular behaviors K.E.L. did exhibit as testified to by his parents, such as inconsolable crying,
jerking spells, and/or manifestation of any type of seizure activity, are specifically excluded as
behaviors constituting the onset of an acute encephalopathy as described in the QAI.
Moreover, while Petitioners allege that K.E.L. exhibited unusual behaviors such as
“uncontrollable” crying, jerking spells, startling, and painful responses that occurred “in the last
few days of February”, there are no medical records that support their claim. After being
vaccinated on February 26, 2014, K.E.L. was not seen for more than one month, 35 days later,
when he was brought to his pediatrician, Dr. Eischens, for complaints of decreased appetite,
coughing, “not acting himself” which, as Petitioners reported, started four days prior. Ex. 27 at 5.
There is no mention at this visit of any unusual behaviors in the few days or even first few weeks
after vaccination.
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At K.E.L.’s nine-month well child visit, he was noted to be a “happy, healthy baby” with
“good bonding with mom.” Ex. 27 at 9. He was meeting developmental milestones and was not
scheduled for another visit until his one-year visit several months later. Id. at 12. These records
are in direct contradiction with Petitioners and the witness affidavits presented. Although Ms.
Lindholm stated that she called Dr. Eischens’s office more than once to inquire about “abnormal
jerking spells”, Ms. Lindholm admits that she has no telephone records to support these statements
and Dr. Eischens’s notes and records make no mention of these reports. Ex. 28 at 1.
I am bound by the evidence before me and unfortunately, there is not a preponderance of
evidence to support Petitioners’ claim that K.E.L. suffered an encephalopathy within 72 hours of
his third DTaP vaccination on February 26, 2014. Thus, Petitioners’ Table claim must fail.
D. Causation in Fact
Because Petitioners have not proven that K.E.L. suffered a Table injury, they must show
that he sustained an injury that was actually caused by the vaccine he received. To do so, they must
establish, by preponderant evidence: (1) a medical theory causally connecting the DTaP vaccine
to K.E.L.’s injury (“Althen Prong One”); (2) a logical sequence of cause and effect showing that
the DTaP vaccine was the reason for his injury (“Althen Prong Two”); and (3) a proximate
temporal relationship between the DTaP vaccine and his injury (“Althen Prong Three”). Althen v.
Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
Petitioners must prove all three prongs by a preponderance of the evidence. For the reasons
set forth below, I find that Petitioners have failed to satisfy the Althen test and are therefore not
entitled to compensation.
1. Althen Prong One: Petitioners have not Provided a Reliable and Reputable Theory
Concerning Whether the Vaccine K.E.L. Received Can Cause Encephalopathy and
Infantile Spasms
Under Althen prong one, Petitioners must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at
1355-56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound
and reliable medical or scientific explanation.” Knudsen v. Sec'y of Health & Hum. Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Proof that the proffered medical theory is plausible or possible does not
satisfy a petitioner’s burden. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359-60
(Fed. Cir. Nov. 7, 2019).
Petitioners may satisfy this prong without resort to medical literature, epidemiological
studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v.
Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing Capizzano, 440
F.3d at 1325-26). However, special masters are “entitled to require some indicia of reliability to
support the assertion of the expert witness.” Boatmon, 941 F.3d at 1360, quoting Moberly, 592
F.3d at 1324. Special Masters, despite their expertise, are not empowered by statute to conclusively
resolve what are complex scientific and medical questions, and thus scientific evidence offered to
establish Althen prong one is viewed “not through the lens of the laboratorian, but instead from
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the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at 1380. Accordingly,
special masters must take care not to increase the burden placed on petitioners in offering a
scientific theory linking vaccine to injury. Contreras v. Sec’y of Health & Hum. Servs., 121 Fed.
Cl. 230, 245 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017); see also Hock v.
Sec’y of Health & Hum. Servs., No. 17-168V, 2020 U.S. Claims LEXIS 2202 at *52 (Fed. Cl.
Spec. Mstr. Sept. 30, 2020).
In evaluating the totality of the evidence in this case, I conclude that Petitioners have failed
to provide preponderant evidence of a medical theory that satisfies Althen prong one.
Dr. Wilkerson opined that vaccines can trigger an “unspecified immune mechanism” in the
individual, although “the exact immune mechanism remains elusive....” First Wilkerson Rep. at 3.
Instead of describing a theory as to how the DTaP vaccine can cause a condition like the one that
K.E.L. experienced, Dr. Wilkerson merely concluded that it was so. His report offers textbook
examples of conclusory opinions. In his first report, for instance, he made the following assertion:
while lacking absolute scientific proof that vaccine causes brain injury in any case,
nevertheless, the preponderance of evidence in this case, at the current level of
scientific understanding about likely mechanisms by which vaccine content may
cause brain injury, supports the medical conclusion that, more likely than not, there
is a significant causal contribution to the encephalopathy present in K.E.L. which
is attributable to the immediate proximate vaccine administered to him in late
February 2014. Stated differently, more likely than not, but for the vaccine
administration of February 2014, K.E.L. otherwise would not have developed
infantile spasms or the related encephalopathy.
Id. at 9.
Dr. Wilkerson did not explain how the DTaP vaccine can cause infantile spasms,
encephalopathy, or any kind of brain injury. Similarly, in his second expert report, Dr. Wilkerson
offered a two-sentence conclusion as a theory:
I retain the opinions expressed in my initial report that K.E.L. has a severe
encephalopathic process with onset at point proximate to his age of 6 months and
the administration of his third vaccine dose of the DTaP. More specifically, my
conclusion is that the available evidence submitted by the Petitioner does fulfill the
specific medical criteria for compensation under the NVIC.
Second Wilkerson Rep. at 4. Again, Dr. Wilkerson failed to explain how the DTaP vaccine can
cause an immune-mediated injury such as infantile spasms and encephalopathy.
When evaluating whether Petitioners have carried their burden of proof, special masters
consistently reject “conclusory expert statements that are not themselves backed up with reliable
scientific support.” Kreizenbeck v. Sec’y of Health & Hum. Servs., No. 08-209V, 2018 WL
3679843, at *32 n.44 (Fed. Cl. Spec. Mstr. June 22, 2018). Special masters cannot rely on “opinion
evidence that is connected to existing data only by the ipse dixit of the expert.” Moberly v. Sec’y
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of Health & Hum. Servs., 85 Fed. Cl. 571, 596 (2009) (quoting Gen. Elec. Co. v. Joiner, 522 U.S.
136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997)), aff’d, 592 F.3d 1315 (Fed. Cir. 2010). Instead,
special masters are expected to carefully scrutinize the reliability of each expert report submitted.
See id.
I am cognizant that Petitioners do not have to provide a specific mechanism of injury,
however their theory must be detailed enough to apply to the specific vaccine and injury in this
case. Otherwise, any vaccine, by virtue of the fact that it elicits an immune response, could be
asserted as the cause of any autoimmune disease. See W.C. v. Sec’y of Health & Hum. Servs., 704
F.3d 1352, 1360 (2013) (finding that a petitioner cannot prevail by simply invoking a biological
term, or by showing that the mechanism is a valid theory to explain how other triggers may have
induced other diseases and determining that a petitioner must produce additional evidence that the
mechanism can cause that vaccine to cause a specific disease); Caves v. Sec’y of Health & Hum.
Servs., 100 Fed. Cl. 119, 135 (2011), aff’d, 463 F. App’x. 932 (2012); McKown v. Sec’y of Health
& Hum. Servs., No. 15-1451, 2019 WL 4072113, *50 (Fed. Cl. Spec. Mstr. July 15, 2019).
Dr. Wilkerson’s statement that vaccines can trigger an “unspecified immune mechanism”
is not a cognizable theory. Petitioners have not provided a sound and reliable medical theory
explaining how the DTaP vaccine can cause infantile spasms or encephalopathy. His reports
amount to no more than ipse dixit, and as such are insufficient for Petitioners to meet their burden
under Althen prong one.
2. Althen Prong Two
Althen prong two requires the Petitioners to establish a logical sequence of cause and effect
demonstrating that the vaccination did cause K.E.L’s condition. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion
testimony are favored in vaccine cases, as treating physicians are likely to be in the best position
to determine whether a ‘logical sequence of cause-and-effect show[s] that the vaccination was the
reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed
as particularly trustworthy evidence, since they are created contemporaneously with the treatment
of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
The evidence in this case suggests that K.E.L.’s infantile spasms, seizure disorder, and
resultant developmental delays were likely caused by abnormal brain development and progressive
microcephaly, which the evidence suggests existed prior to K.E.L.’s third DTaP vaccination on
February 26, 2014. The existence of this prior condition reduces the persuasiveness of Petitioners’
showing that the vaccine “did cause” K.E.L.’s condition. See K.L. v. Sec’y of Health & Hum.
Servs., 134 Fed. Cl. 579, 598 (Fed. Cl. 2017) (“regardless of whether the burden of proof ever
shifts to the respondent, the special master may consider the evidence presented by the respondent
in determining whether the petitioner has established a prima facie case”) (internal citations
omitted).
For the reasons discussed below, the evidence likewise demonstrates that the DTaP vaccine
did not cause K.E.L.’s microcephaly, infantile spasms, and developmental delay.
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Petitioners contend that the second Althen prong has been satisfied because no other cause
for K.E.L.’s condition was identified. Dr. Wilkerson’s report presupposes that because most other
possible causes had been ruled out, the vaccine must have been the cause of K.E.L.’s infantile
spasms and corresponding brain and developmental abnormalities. Specifically, Dr. Wilkerson
opined as follows:
the medical record, specifically the record of the Mayo Clinic evaluation, clearly
satisfies the elimination of all known and identifiable causes of the encephalopathy
in K.E.L. to the level of current medical scientific ability … Since the findings of
that evaluation eliminate all currently known alternative causes other than that of
vaccine injury as the basis of the encephalopathy manifest in K.E.L., the results of
that evaluation are consistent with the hypothesis of vaccine-related brain injury as
its cause but, absent a consensus accepted biologic marker of vaccine-related brain
injury, the hypothesis of vaccine-related brain injury was not scientifically proven.
Id. at 3. This process of elimination of other potential causes, or a diagnosis of exclusion, does not
satisfy Althen prong two. The Federal Circuit has explained that “[a]lthough probative, neither a
mere showing of a proximate temporal relationship between vaccination and injury, nor a
simplistic elimination of other potential causes of the injury suffices, without more, to meet the
burden of showing actual causation.” Althen, 418 F.3d at 1278 (citing Grant, 956 F.2d at 1149).
i. K.E.L. Experienced Evidence of Microcephaly Beginning at Approximately
Two Months of Age
Microcephaly is defined as “abnormal smallness of the head, usually associated with
intellectual disability.” Dorland. (2011). Dorland's Illustrated Medical Dictionary E-Book.
London: Saunders. The medical records show that at birth, August 19, 2013, K.E.L.’s head
circumference was 34.29 centimeters (over the 50th percentile). Ex. 2 at 14, 16. Nine days later,
K.E.L.’s head circumference was nearly the same, measured at 34.30 centimeters. Ex. 6 at 1-2. By
two months of age, K.E.L.’s head circumference had dropped to the 10th percentile, measuring at
38.10 centimeters. Ex. 6 at 1-2.
At the time of K.E.L.’s third DTaP vaccination on February 26, 2014, K.E.L.’s head
circumference had dropped to the 8th percentile, measuring at 41.90 centimeters. Ex. 6 at 1-2. His
overall development was otherwise described as normal. Ex. 27 at 2.
As Dr. Kohrman noted in his first report, K.E.L. had evidence of progressive microcephaly
documented in his medical records starting at age two months, which pre-dates the administration
of the third DTaP vaccine on February 26, 2014. First Kohrman Rep. at 8. Dr. Kohrman observed
that K.E.L.’s head circumference decreased from above the 50th percentile at birth to the 10th
percentile on October 28, 2013, the date of his very first DTaP vaccine. Id.
Although Dr. Wilkerson disputed Dr. Kohrman’s claim that K.E.L.’s microcephaly was
evident at two months of age, his reasoning, which presumes the mismeasurement of head
circumference by K.E.L.’s doctors, is not persuasive. Dr. Wilkerson suggested that the likelihood
of mismeasurement of head circumference in K.E.L.’s circumstances was high, although there is
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no evidence to suggest this occurred. To the contrary, the head circumference measurements from
birth to eight days of age are nearly identical, indicating that the head circumference measurements
were accurate. Dr. Wilkerson also suggested that K.E.L.’s head circumference measurements may
have been entirely normal, as large and small head measurements alike are sometimes seen in
completely normal patients. While this observation is no doubt true, there is no dispute that K.E.L.
eventually developed microcephaly, and thus, the likelihood that his small head circumference at
two months of age was a simple anomaly is not persuasive.
Dr. Kohrman also stated that K.E.L.’s symptoms of epileptic encephalopathy were noted
in the medical records to begin in May and June of 2014, approximately two months after receipt
of his third DTaP vaccine. First Kohrman Rep. at 8. Dr. Kohrman opined that developmental delay
and regression may precede, follow, or begin at the time spasms begin as is noted in the medical
literature. Id. There is no known temporal association between a brain injury and the onset of
infantile spasms, which will be discussed more fully in Althen prong three.
ii. K.E.L.’s Abnormal Brain Development is the Most Likely Cause of his
Infantile Spasms
Dr. Kohrman stated that K.E.L.’s clinical course was “quite typical of cryptogenic infantile
spasms…” First Kohrman Rep. at 9. He persuasively opined that K.E.L.’s medical records
demonstrate he had progressive loss in head circumference from birth, the etiology of which is
unknown as is the etiology of his spasms. Id. With infantile spasms, Dr. Kohrman noted that
“overall 80% of infants with spasms have persistent development delays even with ideal treatment.
Lennox-Gastaut syndrome occurs in approximately half of infants diagnosed with spasm and over
90% have continued seizures after the age of 10 years.” Second Kohrman Rep. at 2. Dr. Kohrman
also confirmed that K.E.L.’s
head circumference growth is the direct result of brain growth and this lack of head
growth is consistent with abnormal brain development as the underlying cause of
his infantile spasms which began prior to vaccinations in question. This is
consistent with an epileptic encephalopathy caused by infantile spasms which did
not occur within 72 hours of vaccination.
Third Kohrman Rep. at 3. I find this opinion to be persuasive.
Ultimately, preponderant evidence supports the fact that K.E.L.’s microcephaly began
before receipt of his third DTaP vaccine on February 26, 2014. Further, a preponderance of the
evidence demonstrates that K.E.L.’s microcephaly is evidence of abnormal brain development that
existed prior to vaccination, and which, more likely than not, resulted in the development of
infantile spasms and resultant developmental delay.
For the reasons discussed in this decision, I find that Petitioners have failed to establish the
second Althen prong.
3. Althen Prong Three
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Althen prong three requires Petitioners to establish a “proximate temporal relationship”
between K.E.L.’s condition and the vaccine he received. Althen, 418 F.3d at 1281. Petitioners must
offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given
the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.”
de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
The timing prong contains two parts. First, Petitioners must establish the “timeframe for
which it is medically acceptable to infer causation” and second, they must demonstrate that the
onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed.
Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012),
aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).
i. The Onset of K.E.L.’s Condition
Dr. Wilkerson explained in detail in his first expert report that identifying the precise timing
of the onset of infantile spasms is “exceedingly difficult”. First Wilkerson Rep. at 4. Dr. Wilkerson
discussed, for nearly half of his report, the subtleties of recognizing signs of the onset of the
disorder, which “for numerous reasons invariably are unrecognized for quite some time.” Id. at 5.
He explained that the initial spasms are “fleeting in duration” and sometimes only produce “a nod
of the head or a barely perceptible jerk or movement of the shoulders, trunk or hips.” Id. He also
explained that a typical infant already demonstrates normal jerky movements at various stages of
infancy and thus, seizures may go undetected. Id. Despite Dr. Wilkerson’s extensive discussion
about the difficulty of identifying the precise onset of infantile spasms, he initially stated the
following with respect to the onset of K.E.L.’s condition:
Thus, an approximation of onset of K.E.L.’s spasms and behavioral changes within
the week or so after the time of immunization, as described in the petitioner’s
affidavit, is as close a fit with the NVICP criteria as can be reasonably expected
given the above discussed peculiarities of infantile spasms and the diagnostic
constraints of bystander recognition.
First Wilkerson Rep. at 6. Two pages later, Dr. Wilkerson shortened this onset window to conform
with the Vaccine Injury Table. He opined that K.E.L.’s infantile spasms “more likely than not …
as best can be approximated, fell within a span of around three days, or seventy-two hours
following the receipt of standard infantile immunization.” Id. at 8. Dr. Wilkerson did not explain
his shift from “within the week or so after the time of immunization” to “within a span of around
three days” following vaccination.
More importantly, Dr. Wilkerson failed to explain how he arrived at either conclusion. He
provided no citations in the medical records to support his opinion that onset occurred either within
one week or three days post-vaccination. In fact, Dr. Wilkerson stated that the first note of a
neurodevelopmental abnormality in K.E.L. was documented in the medical records when K.E.L.
was eight or nine months of age (“[t]he first medically recorded note of neurodevelopmental
abnormality was the report of persisting neonatal responses described when K.E.L. was around
eight- or nine-months age”). Second Wilkerson Rep. at 2. The only information that Dr. Wilkerson
could have relied upon for a three day/72-hour onset of K.E.L.’s infantile spasms is Petitioners’
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own statements reporting K.E.L.’s unusual behavior occurring during the several days and weeks
following vaccination; reporting which is directly contradicted by the contemporaneous medical
records, which establish onset of K.E.L.’s condition about one month before his mid-June 2014
medical appointment ((e.g., Ex. 2 at 92 – On June 14, 2016, Ms. Lindholm reported that for the last
month [approximately May 15, 2016], K.E.L. had been “pretty lazy and laying around a lot.”; Ex. 25 at
40 – On June 19, 2016, the medical record states “[t]his is a previously healthy 10-month-old who had
been well in his normal state of health up until a month back [approximately May 19, 2016] when the
mother noticed that he was not acting himself anymore.”; Ex. 25 at 50 - A progress note dated June 20,
2014, stated that “[t]his is a 10-month-old male who was in a normal state of health until a month prior
[approximately May 20, 2016] when he began having increased lethargy, increased abnormal movement
episodes which appear in clusters at times.”; Ex. 8 at 109 – The earliest reported onset by the
Petitioners was during the intake process at the Mayo clinic evaluation in April 2015, nearly a
year later, when K.E.L.’s mother reported that K.E.L. started to have epileptic spasms in March
2015).
In order to overcome the presumption that contemporaneous written medical records are
accurate, testimony must be “consistent, clear, cogent, and compelling.” Blutstein, 1998 WL
408611, at *5. Because of this presumption, “special masters in this Program have traditionally
declined to credit later testimony over contemporaneous records.” Sturdivant v. Sec’y of Health &
Hum. Servs., No. 07-788V, 2016 WL 552529, at *15 (Fed. Cl. Spec. Mstr. Jan. 21, 2016). See,
e.g., Stevens v. Sec’y of Health & Hum. Servs., No. 90–221V, 1990 WL 608693, at *3 (Fed. Cl.
Spec. Mstr. Dec. 21, 1990); see also Vergara v. Sec’y of Health & Hum. Servs., No. 08–882V,
2014 WL 2795491, at *4 (Fed. Cl. Spec. Mstr. Jul. 17, 2014) (“Special Masters frequently accord
more weight to contemporaneously-recorded medical symptoms than those recorded in later
medical histories, affidavits, or trial testimony.”); See also, Cucuras, 993 F.2d at 1528 (noting that
“the Supreme Court counsels that oral testimony in conflict with contemporaneous documentary
evidence deserves little weight”).
Importantly, this is not a case where the Petitioners failed to report K.E.L.’s condition to a
physician. They presented K.E.L. for treatment and consistently told each treating physician that
K.E.L. began to experience symptoms about one month prior. These affirmative statements
regarding onset are significant: “it must be recognized that the absence of a reference to a condition
or circumstance is much less significant than a reference which negates the existence of the
condition or circumstance.” Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (Fed.
Cl. 1991)(aff'd 968 F.2d 1226 (Fed. Cir. 1992)). I find these repeated statements to medical
providers to be more persuasive than Petitioners’ affidavits prepared in anticipation of litigation.
Dr. Wilkerson’s conclusion that the onset of K.E.L.’s infantile spasms began either 72
hours or within one week post vaccination is not persuasive. Ultimately, the preponderance of the
evidence in this case demonstrates that K.E.L. began experiencing infantile spasms in mid-May of
2014.
ii. The Timeframe for which it is Medically Acceptable to Infer Causation
As discussed earlier in this decision, there is a notable absence of a medical causation
presented by the Petitioners. Just as Dr. Wilkerson did not articulate a theory as to how the DTaP
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vaccine can cause infantile spasms, he also did not provide any meaningful explanation of a
medically appropriate temporal interval.
Petitioners have not established either the timeframe for which it is medically acceptable
to infer causation or that the onset of K.E.L.’s condition occurred during this period. Accordingly,
Petitioners have not presented preponderant evidence in support of the third Althen prong.
VI. CONCLUSION
Petitioners have experienced great suffering as a result of K.E.L.’s condition. However, in
order to find they are entitled to compensation they must preponderantly demonstrate that the
vaccines caused K.E.L.’s condition. Based on the evidence presented in this case, I conclude that
Petitioners have not made such a showing. Their petition is therefore DISMISSED. The clerk
shall enter judgment accordingly. 10
A copy of this Decision shall be sent to Petitioners via U.S. Mail. to the following address:
Erik and Lisa Lindholm
22920 462nd Avenue
Wentworth, SD 57075
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
10 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of a notice
renouncing the right to seek review.
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