VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01648
Package ID: USCOURTS-cofc-1_17-vv-01648
Petitioner: E.E.D.
Filed: 2017-11-01
Decided: 2025-12-04
Vaccine: Rotarix; Pediarix (DTaP/Hep B/IPV); Hib
Vaccination date: 2014-11-05
Condition: bowel obstruction/intussusception, NEC, short gut syndrome, complications, and death
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On November 1, 2017, Alina Derkach filed a petition on behalf of her minor son, E.E.D., alleging that vaccines administered on November 5, 2014 caused bowel obstruction or intussusception and the cascade of abdominal complications that followed. E.E.D. was 69 days old when he received Rotarix, Pediarix, and Hib vaccines. Several days later, he developed serious gastrointestinal symptoms and was ultimately treated for bowel obstruction, necrotizing enterocolitis, adhesions, surgical complications, and short gut syndrome. He later died on November 4, 2023.

The case proceeded as an off-Table claim. Petitioner relied on Dr. John Santoro, who linked the live oral rotavirus vaccine to an intussusception or bowel-injury process. Respondent disputed both the medical theory and the case-specific sequence, arguing that the record did not establish that the vaccinations caused the bowel disease and subsequent complications.

Special Master Daniel T. Horner denied entitlement on March 27, 2025. The Court of Federal Claims later reviewed the case and sustained the denial on December 4, 2025. No compensation was awarded. The public record is extensive on the medical and causation dispute, but the outcome turned on failure to prove vaccine causation by a preponderance of the evidence.

Theory of causation field:
Rotarix, Pediarix (DTaP/Hep B/IPV), and Hib on November 5, 2014, age 69 days, alleged to cause intussusception/bowel obstruction with NEC, adhesions, surgical complications, short gut syndrome, and later death. DENIED. Petitioner Alina Derkach relied on Dr. John Santoro and an off-Table rotavirus/intussusception theory. Respondent disputed diagnosis, mechanism, and case-specific sequence. Special Master Horner denied entitlement on March 27, 2025, and Judge Carolyn N. Lerner denied review and sustained the decision on December 4, 2025.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-01648-1
Date issued/filed: 2025-04-21
Pages: 31
Docket text: PUBLIC DECISION (Originally filed: 3/27/2025) regarding 76 DECISION of Special Master. Signed by Special Master Mindy Michaels Roth. (dkj) Service on parties made.
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Case 1:17-vv-01648-UNJ Document 77 Filed 04/21/25 Page 1 of 31
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1648V
Filed: March 27, 2025
* * * * * * * * * * * * * * *
ALINA DERKACH, *
as administrator and legal representative *
of ESTATE OF E.E.D., *
*
Petitioner, *
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * *
Elizabeth Muldowney, Esq., Sands Anderson PC, Richmond, VA for petitioner.
Emilie Williams, Esq., U.S. Department of Justice, Washington, DC, for respondent.
DECISION1
Roth, Special Master:
On November 1, 2017, Alina Derkach (“petitioner”) filed a petition on behalf of her
minor son, E.E.D., for compensation pursuant to the National Vaccine Injury Compensation
Program.2 ECF No. 1. Petitioner alleges that E.E.D. developed a bowel obstruction and/or
intussusception requiring surgical intervention with resultant complications as a result of the
Rotarix (live rotavirus vaccine), Pediarix (diphtheria, tetanus, acellular pertussis, recombinant
hepatitis B, and inactivated poliovirus vaccine combined), and/or haemophilus influenza type B
(“Hib”) vaccines he received on November 5, 2014. See Amended Petition (“Am. Pet.”), ECF
No. 75. Sadly, E.E.D. passed away on November 4, 2023. Petitioner’s Exhibit (“Pet. Ex.”) 45,
ECF No. 69.
1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims’ website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means
the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the
parties have 14 days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. Any changes will appear in the document posted on the 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 the pertinent subparagraph of 42 U.S.C. § 300aa (2018).

Case 1:17-vv-01648-UNJ Document 77 Filed 04/21/25 Page 2 of 31
I extend my sincerest sympathies to Mr. and Mrs. Derkach on the loss of their son and for
what E.E.D. endured during his short life. However, my decision must be based on the evidence
and on the law. Upon careful evaluation of all the evidence submitted, I find that petitioner has
not provided preponderant evidence that the vaccines E.E.D. received on November 5, 2014
caused him to suffer the injuries alleged.
I. Procedural History
Petitioner filed her petition3 on November 1, 2017, and it was assigned to the
undersigned the following day. ECF Nos. 1, 4.
Petitioner filed medical records on November 3, 2017. Pet. Ex. 1-16, ECF Nos. 6-8.
Respondent filed his Rule 4(c) Report on April 23, 2018 recommending against compensation.
ECF No. 12.
On October 22, 2018, petitioner filed an expert report and supporting medical literature.
Pet. Ex. 17-30, ECF Nos. 17-18. Respondent filed a responsive expert report on May 31, 2019.
Respondent’s Exhibits (“Resp. Ex.”) A-J, ECF No. 23.
The parties exchanged further expert reports on August 9, 2019, October 21, 2019, and
December 20, 2019. Pet. Ex. 34-37, ECF Nos. 29, 36; Resp. Ex. K-M, ECF No. 35.
A Rule 5 conference was held on February 6, 2020 and further expert reports were
ordered. ECF No. 38. Petitioner filed a supplemental expert report on May 6, 2020. Pet. Ex. 38-
40, ECF No. 40. Respondent filed a responsive expert report and supporting literature on July 6,
2020. Resp. Ex. N-U, ECF No. 42.
On August 6, 2020, petitioner filed further medical records and a status report confirming
that the record was complete and requesting that an entitlement hearing be scheduled. Pet. Ex.
41-44, ECF Nos. 43-45. A status conference was held. Petitioner’s counsel advised of the
passing of their expert. Petitioner’s counsel requested time to discuss with her client and with
respondent how to proceed. ECF No. 46.
Over the next year, the parties filed status reports on January 11, 2021, January 19, 2021,
March 18, 2021, May 17, 2021, July 16, 2021, and August 30, 2021. On September 29, 2021,
petitioner filed a status report advising that she was not able to find another expert and requested
that the matter proceed to a ruling on the record. ECF Nos. 47-52, 55.
3 This case was not filed as an on-Table Injury. The Vaccine Injury Table provides for intussusception as a Table
injury for the first two rotavirus vaccinations. 42 C.F.R. § 100.3(a)(XI)(c)(4). However, the Table’s Qualifications
and Aids to Interpretation (“QAI”) state in relevant part: “[T]he following shall not be considered to be a Table
intussusception: Onset in a person with underlying conditions or systemic diseases associated with intussusception
(such as cystic fibrosis, celiac disease, or Kawasaki disease).” § 100.3(c)(4)(ii)(E). The QAI additionally excludes a
Table intussusception if “[onset occurs] within 14 days after an infectious disease associated with intussusception,
including viral disease …, which may be demonstrated by clinical signs and symptoms and need not be confirmed
by culture or serologic testing.” §100.3(c)(4)(ii)(B). Because both of these circumstances apply to E.E.D., petitioner
must pursue an off-Table claim.
2

Case 1:17-vv-01648-UNJ Document 77 Filed 04/21/25 Page 3 of 31
Petitioner filed a Motion for Ruling on the Record on January 25, 2022. Motion, ECF No.
59. Respondent filed his response on March 4, 2022. Response, ECF No. 62. Petitioner filed her
reply on April 15, 2022. Reply, ECF No. 65.
Petitioner advised via status report filed on November 29, 2023 that E.E.D. had passed
away. ECF No. 66. The caption was amended to reflect petitioner as the administrator and legal
representative of E.E.D.’s estate. ECF Nos. 72-75.
This matter is ripe for Decision.
II. Medical Terminology
An intestinal obstruction, also referred to as a “small bowel obstruction”, is a blockage of
the intestine that can be either mechanical or nonmechanical. A “kink” of the bowel, also known
as a volvulus, is a type of mechanical obstruction due to a knotting and twisting of part of the
gastrointestinal tract.4 Resp. Ex. U.5
Intussusception is where one part of the intestine telescopes or folds into the section next
to it, essentially sliding inside itself causing a blockage. It usually involves the small bowel and
can happen in infants, children, and adults. Pet. Ex. 37 at 4;6 Resp. Ex. H at 1, 2.7 The part that
prolapses into the other is called the intussusceptum. The part that receives it is the
intussuscipiens, thus the name intussusception. Resp. Ex. H at 2.
4 Intestinal obstruction, DORLAND’S ILLUSTRATED MEDICAL DICTIONARY 1292 (33rd ed. 2020)
[hereinafter DORLAND’S]; Volvulus, DORLAND’S 2040.
5 Hilbert S. de Vries et al., Cecal Volvulus Caused by a Large Uterine Leiomyoma, 10 INT’L J. SURGERY CASE
REPORTS 97 (2015), filed as “Resp. Ex. U”.
6 Janice A. Kelly, Intussusception, in PEDIATRIC GASTROENTEROLOGY: THE REQUISITES IN PEDIATRICS (Chris A.
Liacouras & David A. Piccoli, 2008), filed as “Pet. Ex. 37”.
7 Shobhit Jain & Michelle J. Haydel, Child Intussusception, STAT PEARLS PUBLISHING (2018), filed as “Resp. Ex.
H”.
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This image is copied from Pet. Ex. 27. Quadrant A shows a double intussusception, and quadrant B shows a single
intussusception. The arrows indicate the direction of the intussusception. Pet. Ex. 27 at 3, Fig. 1.
Intussusception is the most common cause of intestinal obstruction in young children and
is most often idiopathic. Pet. Ex. 28 at 1.8 Roughly 50% of children with intussusception shed
virus in their stool. Adenovirus, enterovirus, and cytomegalovirus are the most common viruses
implicated. Id.
A child with intussusception presents with irritability, vomiting, and bloody or “currant
jelly stool” believed to be a mixture of blood, stool, and mucus. Pet. Ex. 37 at 5.9 Typical
presentation, present in 30-60% of infant patients, includes bouts of colicky pain, vomiting,
pallor, poor perfusion, and passage of currant jelly stool with periods of quiet. Up to 20% have
no pain. Id.
On abdominal radiographs, the pathognomonic sign of intussusception is a crescent
shaped mass within the colon, particularly the transverse colon, just beyond the hepatic flexure.
The absence of bowel gas in the ascending colon is one of the most specific signs of
intussusception on imaging. Ultrasound (“US”) is the preferred testing as x-rays have low
8 Christine G. Robinson et al., Evaluation of Anatomic Changes in Young Children with Natural Rotavirus Infection:
Is Intussusception Biologically Plausible?, 189 J. INFECTIOUS DISEASES 1382 (2004), filed as “Pet. Ex. 28”.
9 Kelly, supra note 6.
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sensitivity. Pet. Ex. 35 at 2.10 Ultrasounds can also assist in evaluating the preferred intervention
for reducing the intussusception. Id. at 2-3.
Rotavirus is the most common cause of diarrhea in infants and children. Pet. Ex. 25 at
1.11 Studies have shown an increased risk of intussusception following RotaTeq and Rotarix
vaccines within 7 days of vaccination. Resp. Ex. F at 7.12 While these earlier versions of the
rotavirus vaccine, which are no longer used, were thought to cause intussusception, current
rotavirus vaccines are not clearly linked. Resp. Ex. H at 2.13
Cri-du-Chat Syndrome is a genetic disease resulting from the deletion or partial deletion
of part of chromosome 5. Its clinical symptoms include a high-pitched cat cry, distinct facial
dysmorphism, microcephaly, and severe psychomotor and mental disability. Pet. Ex. 39 at 1.14
Other malformations of the cardiac, neurological, and renal systems may be present. Id. at 1, 2.
Recurrent respiratory and intestinal infections are reported during the first year of life. Id. at 2. In
one study of eighty children, 92% experienced neonatal complications at birth including poor
sucking, respiratory distress, and jaundice. Resp. Ex. C at 4.15 Twenty-seven percent of the
children with unbalanced translocation (not isolated deletion) had gastrointestinal tract
abnormalities including intestinal malrotation, Hirschsprung disease,16 adynamic ileus, and
bowel obstruction. Id. at 4-5.
Necrotizing enterocolitis (“NEC”) is a disease affecting primarily premature, stressed
infants. Distinguishing NEC from intussusception can be difficult because the symptoms
significantly overlap with both involving abdominal distention,17 vomiting or gastric retention,
and gastrointestinal bleeding. Pet. Ex. 29 at 1, 2.18
III. Background
10 Kimberly E. Applegate, Intussusception in Children: Evidence-Based Diagnosis and Treatment, 39 PEDIATRIC
RADIOLOGY S140 (2009), filed as “Pet. Ex. 35”.
11 Judith Koch et al., Risk of Intussusception After Rotavirus Vaccination, 114 DEUTSCHES ARZTEBLATT INT’L 255
(2017), filed as “Pet. Ex. 25”.
12 Anthony T. Manning & Danny C. Little, Intussusception in Infants and Children, in PEDIATRIC
GASTROINTESTINAL AND LIVER DISEASE (Robert Wyllie et al., 2016), filed as “Resp. Ex. F”.
13 Jain & Haydel, supra note 7.
14 Paola Cerruti Mainardi, Review: Cri du Chat Syndrome, 1 J. RARE DISEASES 33 (2006), filed as “Pet. Ex. 39”.
15 Louise E. Wilkins, Ph.D. et al., Clinical Heterogeneity in 80 Home-Reared Children with Cri du Chat Syndrome,
102 J. PEDIATRICS 528 (1983), filed as “Resp. Ex. C”.
16 Hirschsprung disease involves dilatation of a section of the colon due to congenital absence of intrinsic ganglion
cells in the myenteric and submucosal plexuses of the next distal segment; the aganglionic part is abnormally
narrow, and its loss of motor function causes massive hypertrophic dilatation of more proximal segments. The
condition appears soon after birth, is more common in males, and causes extreme constipation, abdominal
distention, and sometimes vomiting; when severe, it may result in growth retardation. It is sometimes divided into
short-segment and long-segment forms, may occur as an isolated trait or in conjunction with other congenital
anomalies, and may show dominant, recessive, or multigenic patterns of inheritance, with gender-dependent
penetrance. It has been associated with mutations in one or a combination of several genes, including genes
encoding either a protein-tyrosine kinase receptor (RET) or one of its ligands, and genes encoding either endothelin-
3(EDN3) or its receptor (EDNRB). Congenital megacolon, DORLAND’S 1106.
17 Distention refers to enlargement. Distention, DORLAND’S 550.
18 Shinichiro Hirokawa et al., Ileoileal Intussusception and Ileal Stricture Associated with Necrotizing Enterocolitis
in a Premature Infant: Report of a Case, 31 SURGERY TODAY 1097 (2001), filed as “Pet. Ex. 29”.
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A. E.E.D.’s History Prior to the Subject Vaccination
E.E.D. was the product of a pregnancy complicated by low fetal growth and ultrasound
findings of microcephaly, cerebral hypoplasia, and micrognathia. Pet. Ex. 5 at 5; Pet. Ex. 6 at 35;
see generally Pet. Ex. 3; Pet. Ex. 4. E.E.D. was born on August 28, 2014 at 41 weeks gestation
via spontaneous vaginal delivery. Pet. Ex. 5 at 2. At birth, microcephaly, micrognathia, and
dysmorphic features were noted. Pet. Ex. 6 at 35. E.E.D. was transferred to the neonatal intensive
care unit (“NICU”) where he remained for the first several weeks of his life. Genetic testing
showed Cri-du-Chat syndrome, a deletion of part of chromosome 5 associated with hoarse cry,
failure to thrive, feeding difficulties, and intellectual disabilities. Id. at 34, 37, 1644, 1655, 1751.
Additionally, E.E.D. had brain anomalies, anemia, feeding problems, gastroesophageal reflux,
and congenital anomalies including ventricular septal defect (“VSD”), laryngomalacia, and
stridor. Id. at 1-2, 1638-39. His anomalies caused feeding difficulties, and he required a
nasogastric tube and nasal cannula for respiratory support. Id. at 19-20, 23, 1640-41, 1751.
At five days old, E.E.D. developed abdominal distention and possible bowel obstruction
on x-ray. He was diagnosed with necrotizing enterocolitis (“NEC”), and antibiotics were started.
Pet. Ex. 6 at 17, 23, 91-92, 1614-15. Repeat x-rays showed possible sentinel bowel loop. Id. at
14, 131, 1620, 1893. A nuclear medicine scan on September 20, 2014 revealed gastroesophageal
reflux with aspiration and a gastrostomy tube (“G-Tube”)19 was placed for feeding and
fundoplication20 performed on October 2, 2014. Id. at 19-23, 40, 1111, 1640. Antibiotics for
suspected aspiration pneumonia were given. Id. at 21.
E.E.D. was medically fragile with pain and agitation. He was maintained on fentanyl with
rescue morphine. Pet. Ex. 6 at 54. He received therapies for significant shoulder winging and
difficulty with upper extremity extension. He had low muscle tone with significant tightness of
the shoulders, hips, knees, and elbows. He also had neurological impairments. Id. at 48. He was
discharged home on October 17, 2014 with a G-tube. Id. at 43.
E.E.D. was presented to his pediatrician on October 20, 2014. It was noted that after birth
he admitted to the NICU for hypotonia and was discharged three days ago. He had Cri-du-Chat
syndrome, developmental delay, G-tube feeding, congenital stridor, VSD, poor weight gain, and
microcephaly. He had soft stools a couple times a day but cries and “tends to be quite fussy”.
Pet. Ex. 9 at 1. He was to return in three days to determine if an increase in feeds was necessary.
Id. at 2. The pediatrician advised that phenobarbital for fussiness could not be started outpatient
due to risk of apnea and would have to be done as an inpatient. Id. at 1, 2. He received his HBV
vaccine just prior to hospital discharge, and it was recommended that the vaccine schedule start
in approximately 2 weeks. Id. at 2.
19 A gastrostomy tube is inserted through a stoma on the body surface into the stomach in a gastrostomy, which is
the surgical creation of an artificial opening into the stomach. Gastrostomy tube, DORLAND’S 1946; Gastrostomy,
DORLAND’S 758.
20 Fundoplication is plication of the fundus of the stomach around the lower end of the esophagus, done as treatment
for reflux esophagitis. Fundoplication, DORLAND’S 741.
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E.E.D. was presented to the pediatrician on October 23, 2014 with continued fussiness,
gassiness, and discomfort. Even with fundoplication, his mother and aunt thought he still had
reflux when lying down. Yellow, watery, and loose stools were reported without blood or mucus.
His mother was also concerned about the area around the G-tube being red. Pet. Ex. 9 at 2. On
examination his abdomen was soft and nondistended, but he fussed with palpation. Id. at 3. G-
tube care was discussed, as was E.E.D.’s fussiness being characteristic of Cri-du-Chat so he may
not have been in pain or uncomfortable. Peppermint tea was suggested. Id.
He was seen at Spokane Ear, Nose and Throat Clinic and Surgical Specialists for
laryngomalacia on October 28, 2014. He was 8 weeks old and doing well with his G-
tube/fundoplication. He had a noisy, wet upper airway but no regurgitation, cyanosis, apnea, or
deep sternal retractions noted by mother. He had a complex history of chromosome 5 deletion,
VSD, microcephaly, GERD, and severe micrognathia with laryngomalacia. He was gaining
weight slowly. Pet. Ex. 10 at 1. The assessment was respiratory insufficiency, major anomalies
of jaw size, and Cri-du-Chat syndrome but no evidence of life-threatening airway events. Id. at 2.
He was not expected to have an easy transition to oral feedings, but they were hopeful he would
eventually swallow safely. Id.
On October 30, 2014, E.E.D. was presented to the pediatrician for his 8-week well check.
He was doing well according to cardiology and ENT check-ups. His mother was concerned
about a facial and neck rash. He had not gained weight. Stools were soft but not runny. E.E.D.
slept all night but for diaper changes. Pet. Ex. 9 at 4. Vaccines were declined but his mother
planned to discuss vaccinations with her husband. Id. at 7. His feeds were to increase with
weight recheck in a week. Id.
B. E.E.D.’s History Following the Subject Vaccination
On November 5, 2014, E.E.D. was presented to the pediatrician for weight check. He was
tolerating his feeding regimen, stools had normalized, and he was seen by the surgeon earlier that
day for G-tube concerns. Pet. Ex. 9 at 8. He had excellent weight gain. Id. at 9. He received the
Pediarix, Hib, and Rotarix vaccines at this visit and planned to receive the Prevnar vaccine in
two weeks at his next recheck. Id.; Pet. Ex. 12 at 1.
E.E.D. was presented to the ER on November 9, 2014. His mother reported multiple
episodes of watery, non-bloody, non-mucoid diarrhea that began around noon yesterday and
continued through the night and early morning. She was concerned for dehydration due to dry
and tacky mouth, so she brought him to the ER. Pet. Ex. 6 at 2009-10. He was fed breast milk
only and had no fever or sick contacts. His G-Tube site was improving, and redness was
decreasing. Id. at 2010. Upon examination, his abdomen was distended and firm but not rigid,
and he had decreased bowel sounds. Id. at 2012. Venting the G-tube released a small amount of
gas and stomach content but did not significantly reduce the abdominal distention. Id. The
assessment was a 2-month-old with loose stool and poor hydration. Id. at 2013. He was
rehydrated with minimal response. His abdomen was “remarkably distended” and x-ray showed
a small bowel obstruction. Abdominal distention was enough to decrease lung volume and
increase respiratory rate. The differential diagnoses included simple acute viral gastroenteritis,
small bowel obstruction, intestinal perforation, or other intra-abdominal process. He was
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afebrile, with normal white blood cell count. He was admitted to the Pediatric Intensive Care
Unit (“PICU”) Id.
An abdominal x-ray showed gastrostomy tube and “[m]ultiple loops of distended small
bowel with multiple air-fluid levels consistent with small bowel obstruction”. The impression
was small bowel obstruction without pneumatosis or intra-abdominal free air. Pet. Ex. 6 at 2029,
2034. An exploratory laparotomy21 was done that day, which showed a kink in the small bowel
at the terminal ileum that was easily reduced. Id. at 2020-21. In the days that followed, E.E.D.
required mechanical ventilation. He tested positive for enterovirus and rhinovirus with fever and
sepsis. Id. at 2050-52. It was noted in the medical record that enterovirus was “[l]ikely the cause
of his ileus/SBO”. Id. at 2503. Abdominal ultrasounds performed on November 10, November
13, and November 14, 2014 showed numerous loops of fluid filled bowel in the abdomen. Id. at
2059-62. His clinical status worsened with increasing fever and bloody diarrhea. Imaging
showed severe colitis causing his abdominal distention. Id. at 2511-12.
Additional surgery was performed on November 23, 2014 due to suspicion of necrotizing
enterocolitis with symptoms of ongoing abdominal distention, sepsis, and bloody stools. The
operative report documented extensive adhesions throughout the entire abdomen involving
mostly the small bowel. Several parts of the small bowel contained “thick, indurated, hyperemic
dense adhesions”. Pet. Ex. 6 at 2020, 2068-69. No report of or findings of intussusception were
noted. Id. at 2069-70.
E.E.D. remained hospitalized until December 22, 2014. He required IV fluids,
mechanical ventilation, seizure medication, a PICC line and multiple courses of antibiotics. He
required two ECHOs for bacteremia. Pet. Ex. 6 at 2019-20. He was planned for re-anastomosis
in early January following his ileostomy and mucous fistula. He had underlying tracheomalacia.
He required methadone to wean off the narcotic medications he had been taking during
hospitalization. He had PICC line infections with enterococcus and MSSA requiring removal and
reinsertion of his PICC line prior to discharge. Id.
On January 5, 2015, E.E.D. was presented to the pediatrician for follow up of a prolonged
hospitalization for kinked bowel with resection. He was weaning from narcotics and sedation and
was fussy. Prevnar 13, Hib, and Pediarix vaccinations were administered at this visit. Pet. Ex. 9
at 10, 302; Pet. Ex. 12 at 1. Two days later, he was presented to his pediatrician again for a sick
visit with symptoms of fever, cough, and congestion. Pet. Ex. 9 at 14-15. Because he was a high-
risk patient, he was sent to the hospital. Id. at 15.
On January 16, 2015, E.E.D. was admitted to the hospital for re-anastomosis22 of the
ileostomy and mucous fistula. Pet. Ex. 6 at 5433, 5445-47. Follow up abdominal x-ray on
February 5, 2015 showed no evidence of obstruction or anastomotic structure. Pet. Ex. 6 at 5801,
5806.
21 A laparotomy involves surgical incision into the abdominal cavity. Laparotomy, DORLAND’S 991.
22 Anastomosis refers to a connection between two vessels or other tubular structures or an opening created by
surgical, traumatic, or pathological means between two normally separate spaces or organs. Anastomosis,
DORLAND’S 74.
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E.E.D.’s medical course thereafter was complicated by many visits to the ER and
prolonged hospitalizations for infections including RSV, fever, breathing problems, watery
diarrhea and vomiting, line infections, blood transfusions for anemia, C. Difficile requiring two
fecal transplants, bowel obstructions requiring additional laparotomies, other aggressive medical
therapies, and enteral support with PICC lines for home TPN and antibiotics. See, e.g., Pet. Ex. 6
at 5786, 5814-15, 5820, 5825, 5831, 7236, 7240, 7244, 7262, 7501, 7507; Pet. Ex. 9 at 16-45. He
was also diagnosed with pancreatic deficiency and Hirschsprung’s disease. Pet. Ex. 6 at 7517,
7620.
Sadly, E.E.D. passed away on November 4, 2023 at the age of 9. The cause of death was
listed as A) septic shock related to intra-abdominal infection, interval 36 hours; B) Anastomotic
leak from previous extensive exploratory laparotomy, lysis of adhesions, and small bowel
resection, interval 36 hours; C) High grade small bowel obstruction, interval 8 days; and D)
Short gut syndrome, interval 9 years. Other conditions contributing to death included Cri-du-
Chat syndrome, Hirschsprung’s disease, SLC9A3 mutation, and developmental delay. Pet. Ex.
45.
C. Affidavits
1. Affidavit of Alina Derkach
Alina Derkach is E.E.D.’s mother. Pet. Ex. 1. According to Ms. Derkach, E.E.D. spent 8
weeks in the hospital following his birth due to oxygen and feeding issues. He was doing great
when discharged and getting the proper nutrition via G-tube. Id. at 1.
Ms. Derkach affirmed taking E.E.D. to the pediatrician on November 5, 2014 for follow
up and vaccinations. He received the oral rotavirus, Pediarix, and Hib vaccines and had some
fever and irritability following the vaccinations. On November 8, 2014, he started to have
diarrhea. She contacted the pediatrician’s office to advise that E.E.D. had severe diarrhea and
was inconsolable. Pet. Ex. 1 at 1.
Ms. Derkach affirmed that on November 9, 2014, E.E.D. was presented to the ER and
was diagnosed with a small bowel obstruction “about 5 cm from the ileocecal valve and severe
dehydration.” Pet. Ex. 1 at 1. An exploratory laparotomy was performed that night and E.E.D.
was then admitted to the PICU. Id. at 1-2. He had a lot of complications after the surgery
including respiratory failure and tachycardia, requiring extended intubation and a central venous
catheter. Id. at 2. E.E.D. continued to have abdominal pressure and was thought to have a
perforation. He developed a fever and his abdomen became distended. A CT scan on November
14, 2014 showed no signs of obstruction. On November 19, 2014, the doctor advised that E.E.D.
had developed severe colitis which likely caused his “abdominal extension and not another
obstruction.” Id. He continued to have fever and bloody stools and the doctors advised that he
was at increased risk for additional complications and recommended another exploratory
laparotomy. E.E.D.’s ileum was resected, and ileostomy performed. An appendectomy was done
at that time as well. E.E.D. had a colostomy bag for a few months with some additional
complications but began to stabilize and was taken home on December 22, 2014. Pet. Ex. 1 at 2.
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Ms. Derkach affirmed that E.E.D. continued to have loose stools from having his large
intestine and colon removed. He had food sensitivities, would get severe diarrhea with a minor
cold, needed daily medication for his gut, and still had a G-tube. Pet. Ex. 1 at 2. His life was very
complicated mostly with gut issues because he did not absorb as much as a typical child. He was
in and out of the hospital for stomach and intestinal issues. Id.
Ms. Derkach believes “that had it not been for the Rotavirus vaccination that [E.E.D.]
received on November 4, 2014, he would never have developed a bowel obstruction and
resulting surgery.” Pet. Ex. 1 at 2.
2. Affidavit of Ervin Derkach
Mr. Derkach is E.E.D.’s father. Mr. Derkach similarly affirmed that E.E.D. spent 8 weeks
in the NICU after birth due to oxygen and feeding issues. Pet. Ex. 2 at 1. After discharge, he was
doing great and getting proper nutrition through his G-tube. He received the oral rotavirus,
Pediarix, and Hib vaccines on November 5, 2014. Id.
According to Mr. Derkach, E.E.D. had a fever and irritability following his vaccinations
then began to have severe diarrhea and was inconsolable on November 8, 2014. His wife told
him she called the pediatrician. Pet. Ex. 2 at 1. Mr. Derkach stated he was at work during the
daytime, so his wife usually took care of E.E.D. and took him to his appointments. Id.
The remainder of his affidavit is the same as his wife’s. Pet. Ex. 2 at 1-3.
D. VAERS Report
Petitioner completed a VAERS report on January 24, 2016. Pet. Ex. 14. According to the
report, E.E.D. received DTaP, Hep B, and Pediarix vaccines on October 28, 2014 at 11:30am
with the adverse event onset on October 28, 2014 at 3pm. The adverse event was described as
“Inconsolable, diarrhea, temperature” with “[s]urgery on 11/09/2014 for a kinked intestine,
ileostomy and colostomy placed, caused colitis.” Id. at 1. Medical records were attached.
IV. Expert Opinions
A. Petitioner’s Expert, Dr. John Santoro
Dr. Santoro obtained his B.A. in biology from LaSalle College in 1973 and his D.O. from
Philadelphia College of Osteopathic Medicine in 1978. Pet. Ex. 18 at 1. He completed an
internship at John F. Kennedy Memorial Hospital from 1978–79 and performed his residency in
internal medicine at the University of Medicine and Dentistry at the NJ School of Osteopathic
Medicine from 1979–81. Id. Dr. Santoro also completed a fellowship in gastroenterology at the
University of Medicine and Dentistry NJ School of Osteopathic Medicine from 1981–83. Id. at
2. He is board certified in internal medicine and gastroenterology. Id. He served as a clinical
associate professor of medicine at Rowan University School of Osteopathic Medicine since
1983, in addition to being a clinician at Atlantic Gastroenterology Associates. Id. at 1, 3. Dr.
Santoro has since passed away.
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Dr. Santoro wrote four reports in this matter. Pet. Ex. 17; Pet. Ex. 34; Pet. Ex. 36; Pet.
Ex. 38. In Dr. Santoro’s opinion, E.E.D. suffered an intussusception and later NEC requiring
surgery as a result of the rotavirus vaccine he received on November 5, 2014.
Dr. Santoro provided a cursory medical summary of E.E.D.’s medical history prior to the
November 5, 2014 rotavirus vaccine which included that he was born with microcephaly, mild
micrognathia, and Cri-du-Chat syndrome and spent 8 weeks in the NICU before being
discharged home. Pet. Ex. 17 at 3; Pet. Ex. 38 at 2. He explained the clinical features of Cri-du-
Chat but said that “bowel obstruction is not reported as a prominent feature of this syndrome”.
Pet. Ex. 38 at 2. Thus, he did not feel as though Cri-du-Chat was the cause of E.E.D.’s bowel
obstruction. Id. He detailed E.E.D.’s history from the date of the vaccinations onward. Pet. Ex.
17 at 3-4; see also Pet. Ex. 34 at 1-2.
Dr. Santoro described intussusception as a rare bowel obstruction where the bowel folds
or telescopes in on itself and is most common in young children. Pet. Ex. 17 at 5. The most
common place for the intussusception to occur is where the small bowel joins the large bowel or
colon, although it can occur in other parts of the intestine as well. Most people fully recover with
prompt treatment, but a partial or incomplete intussusception can resolve spontaneously. “Infants
with intussusception may become ill with vomiting, abdominal pain, and may also have blood in
the stool.” Id. Most often, no cause is identified. Intussusception has been associated with
structural abnormalities and infection, such as adenovirus. It can be treated by a radiologist by
unfolding the intestine to normal position with an enema of air or fluid under pressure. If
unsuccessful, surgery is required to unfold or resect that part of the intestine causing the
blockage. Id.; see also Pet. Ex. 38 at 2; Pet. Ex. 40.23
He then discussed the history of various vaccines for rotavirus, including RotaShield and
Rotateq, which were reported to be associated with intussusception. Pet. Ex. 17 at 5-6; Pet. Ex.
19.24 Dr. Santoro submitted that VAERS has a reported 584 “confirmed intussusception events
after administration of the Rotateq vaccine reported” between 2006 and 2012. Id.
Dr. Santoro quoted the package insert for the Rotarix vaccine, which is the vaccine
E.E.D. received. Pet. Ex. 17 at 7; Pet. Ex. 20 at 5.25 Based on the studies cited within the package
insert, Dr. Santoro claimed that intussusception was “observed in temporal association within 31
days following the first dose of [Rotarix], with a clustering of cases in the first 7 days.” Id.
(emphasis in original). There is also support for intussusception within the first 7 days after the
second dose of Rotarix. Id.; see also Pet. Ex. 21;26 Pet. Ex. 22;27 Pet. Ex. 25.28 According to Dr.
23 Roben ECZ & Horowitz R, Rate of Spontaneous Resolution of Idiopathic Ileocolic Intussusception, 7 ACAD. J.
PEDIATRICS & NEONATOLOGY 18 (2018), filed as “Pet. Ex. 40”.
24 Perina Haber, MPH et al., Intussusception After Rotavirus Vaccines Reported to US VAERS, 2006-2012, 131
PEDIATRICS 1042 (2013), filed as “Pet. Ex. 19”.
25 GlaxoSmithKline, Rotarix Package Insert, (2016), filed as “Pet. Ex. 20”.
26 Manish M. Patel et al., Intussusception Risk and Health Benefits of Rotavirus Vaccination in Mexico and Brazil,
364 NEW ENG. J. MED 2283 (2011), filed as “Pet. Ex. 21”.
27 Harry B. Greenberg, M.D., Rotavirus Vaccination and Intussusception—Act Two, 364 NEW ENG. J. MED 2354
(2011), filed as “Pet. Ex. 22”.
28 Koch et al., supra note 11.
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Santoro, the first week after receipt of rotavirus vaccination is the most common time for
intussusception to occur. Pet. Ex. 17 at 11.
Dr. Santoro also cited Weintraub, which discussed the risk of intussusception following
the monovalent rotavirus vaccination and found “a significant increase in the rate of
intussusception after vaccination. After two doses of the monovalent Rotavirus vaccine, the
estimated risk was 5.3 per 100,000 infants vaccinated.” Pet. Ex. 17 at 8; Pet. Ex. 23.29 Similarly,
Yih found that the rotavirus vaccine “was associated with an approximate 1.5 . . . excess cases of
intussusception per 100,000 recipients of the first dose.” Pet. Ex. 17 at 8; Pet. Ex. 24.30
Dr. Santoro acknowledged that further research is needed to increase the understanding
of the pathogenesis and etiology of intussusception. Pet. Ex. 17 at 9. However, he submitted that
a mice study suggested that rotavirus infection enhances tumor necrosis factor alpha and gamma
interferon cytokine levels following the introduction of lipopolysaccharide. Id.; Pet. Ex. 27.31 Dr.
Santoro interpreted this study as suggesting rotavirus infection and vaccination with a live
rotavirus vaccine can sensitize mice to the inflammatory effects of LPS treatment, thereby
enhancing intussusception rates. Id. Further, ultrasound studies of infants with rotavirus infection
have shown increased distal ileal wall thickness and lymphadenopathy, suggesting “a plausible
mechanism by which Rotavirus infection could cause intussusception.” Pet. Ex. 17 at 9; Pet. Ex.
28.32
Although E.E.D. was not diagnosed by his treating providers with an intussusception, Dr.
Santoro submitted that he did have an intussusception on November 9, 2014. According to Dr.
Santoro, following the Rotarix vaccine on November 5, 2014, E.E.D. developed diarrhea, severe
pain, and lethargy and had feeding problems, GERD, and rectal bleeding (hematochezia).33 Pet.
Ex. 17 at 10. An abdominal scan showed a bowel obstruction. E.E.D. required an exploratory
laparotomy to release the small bowel obstruction “and presumed intussusception”. Pet. Ex. 17 at
7, 10; Pet. Ex. 6 at 2072-73. During surgery, “kinking of the distal small bowel was noted just
proximal to the ileocecal valve”, and Dr. Santoro opined this “kinking was the remnants of an
intussusception which was the cause of the small bowel obstruction.” Pet. Ex. 17 at 10; Pet. Ex.
30;34 Pet. Ex. 34 at 2; Pet. Ex. 38 at 2-3.
Dr. Santoro agreed that intussusception presents with a “classic triad” of abdominal pain,
vomiting, and currant jelly stool but referenced Carty which showed only one to two-thirds of
patients present with these symptoms. Pet. Ex. 34 at 2; Resp. Ex. D.35 However, he also
29 Eric S. Weintraub, M.P.H. et al., Risk of Intussusception After Monovalent Rotavirus Vaccination, 370 NEW ENG.
J. MED 513 (2014), filed as “Pet. Ex. 23”.
30 W. Katherine Yih, Ph.D., M.P.H. et al., Intussusception Risk After Rotavirus Vaccination in U.S. Infants, 370
NEW ENG. J. MED 503 (2014), filed as “Pet. Ex. 24”.
31 Kelly L. Warfield et al., Rotavirus Infection Enhances Lipopolysaccharide-Induced Intussusception in a Mouse
Model, 80 J. VIROLOGY 12377 (2006), filed as “Pet. Ex. 27”.
32 Robinson et al., supra note 8.
33 The records Dr. Santoro cited only support that E.E.D. presented with diarrhea. The other symptoms were not
reported. Pet. Ex. 6 at 2010-13.
34 Emrah Aydin, Intussusception in a Preterm Newborn, 59 PEDIATRICS AND NEONATOLOGY 312 (2018), filed as
“Pet. Ex. 30”.
35 H.M.L. Carty, Paediatric Emergencies: Non-Traumatic Abdominal Emergencies, 12 EUROPEAN RADIOLOGY 2835
(2002), filed as “Resp. Ex. D”.
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submitted that E.E.D. presented with abdominal pain, vomiting, and rectal bleeding. Pet. Ex. 34
at 2-3.
Dr. Santoro further explained that the gold standard to diagnose an intussusception is
ultrasound. Ultrasound is also required for evaluation of reducibility, presence, location,
diagnosis, and exclusion of residual intussusception after enema, and identification of alternative
diagnoses. It has a high accuracy at 98-100%. Pet. Ex. 34 at 2; Pet. Ex. 35;36 Pet. Ex. 38 at 2-3.
He pointed to a textbook edited by Dr. Liacouras which states that ultrasound is the suggested
screening test. Pet. Ex. 36 at 2; Pet. Ex. 37;37 Pet. Ex. 38 at 2-3. Here, only an x-ray was
performed, which has a low sensitivity rate and is not recommended to diagnose intussusception.
Pet. Ex. 34 at 2; Pet. Ex. 35. Thus, Dr. Santoro argued E.E.D.’s intussusception was missed
because the “’gold standard’ diagnostic tests were not done”. Pet. Ex. 36 at 2; Pet. Ex. 38 at 3.
Dr. Santoro further discussed the November 23, 2014 intraoperative endoscopy on the
small and large bowel, which revealed normal appearing mucosa of the colon but stated that the
distal small bowel was inflamed, thickened, and bleeding. Pet. Ex. 17 at 10; Pet. Ex. 6 at 2068-
70. These findings were consistent with necrotizing enterocolitis, which he opined was caused by
the intussusception. “It has been suggested that mesenteric and enteric vascular ischemia could
be one trigger of intussusception in neonates.” Id.; Pet. Ex. 29;38 Pet. Ex. 34 at 3; Pet. Ex. 38 at
3. In other words, he believed the Rotarix vaccination caused an intussusception, which in turn
“caused or precipitated” his subsequent NEC, which required surgical intervention. Pet. Ex. 34 at
3; Pet. Ex. 38 at 3.
He disagreed that E.E.D.’s small bowel obstruction resulted from adhesions caused by his
prior laparoscopic fundoplication with gastrostomy placement because “adhesions only form
after abdominal surgery”. Pet. Ex. 34 at 3. He argued that the prior surgery was only a
laparoscopic fundoplication—not an open procedure—and it was in the upper abdomen, not the
lower abdomen where the obstruction occurred. Id.; Pet. Ex. 36 at 2. He added that even the
literature Dr. Liacouras submitted states that the risk of adhesions is low after laparoscopic
surgery in children. Pet. Ex. 36 at 2; Resp. Ex. L;39 Resp. Ex. M.40
In summary, Dr. Santoro argued the medical theories and experimental evidence he
provided shows the mechanism by which rotavirus vaccine, specifically Rotarix, can cause
intussusception and bowel obstruction in certain patients and satisfies prong one. Pet. Ex. 17 at
11. According to Dr. Santoro, prior to the November 5, 2014 rotavirus vaccine, E.E.D. had no
prior history of small bowel obstruction or intussusception. But within three days of receiving
the rotavirus vaccine, E.E.D. suffered a small bowel obstruction due to intussusception. In his
opinion, the Rotarix vaccine caused the intussusception and bowel obstruction, as well as the
sequela of these injuries as detailed in the medical records in satisfaction of prong two. Id. There
is no other more likely identifiable cause in the records. Pet. Ex. 34 at 3; Pet. Ex. 38 at 3. Finally,
36 Applegate, supra note 10.
37 Kelly, supra note 6.
38 Hirokawa et al., supra note 18.
39 Ngozi J. Nwokoma, MRCS et al., Trocar Site Adhesions After Laparoscopic Surgery in Children, 19 SURGICAL
LAPAROSCOPY ENDOSCOPY & PERCUTANEOUS TECHNIQUES 511 (2009), filed as “Resp. Ex. L”.
40 G. Polymeneas et al., A Comparative Study of Postoperative Adhesion Formation After Laparoscopic vs. Open
Cholecystectomy, 15 SURGICAL ENDOSCOPY 41 (2001), filed as “Resp. Ex. M”.
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the literature shows that intussusception following rotavirus vaccination is most common within
7 days. Here, E.E.D. developed intussusception within 3 days of receipt of the Rotarix vaccine,
thus satisfying prong three. Pet. Ex. 17 at 11.
B. Respondent’s Expert, Dr. Chris Liacouras
Dr. Liacouras received his B.A. from Johns Hopkins University in 1981 and his M.D.
from Harvard Medical School in 1985. Resp. Ex. B at 1. He completed a postdoctoral fellowship
in pediatric gastroenterology and nutrition at Children's Hospital of Philadelphia (“CHOP”).
Since then, he has been on faculty at Harvard Medical School, University of Pennsylvania
School of Medicine, and at CHOP, serving in various capacities, including as a professor of
pediatrics and as the Medical Director of CHOP Center for Gastrointestinal Endoscopy. Id. at 1-
2; Resp. Ex. A at 3. He is board-certified in pediatric gastroenterology. Resp. Ex. A at 1. Dr.
Liacouras has evaluated between 2000-3000 pediatric patients with all types of gastrointestinal
disorders over the course of his career. Id. at 3. He has evaluated or consulted on more than 100
pediatric patients with intussusception. Id.
Dr. Liacouras issued three reports in this case. Resp. Ex. A; Resp. Ex. K; Resp. Ex. N. It
is his opinion that E.E.D. had a small bowel obstruction on November 9, 2014, which was
mostly likely due to complications from the various conditions he was born with. Resp. Ex. A at
6.
Dr. Liacouras detailed E.E.D.’s medical history in the first eight weeks of life and prior to
his receipt of the rotavirus vaccination in which he was diagnosed with abdominal distention,
hematemesis, distal bowel obstruction at 5 days of age, necrotizing enterocolitis requiring
antibiotics, sentinel bowel loop, and severe gastroesophageal reflux disease requiring
laparoscopic Nissen fundoplication and G-tube placement. Resp. Ex. A at 1-2.
Dr. Liacouras then detailed the medical events following the November 5, 2014
Rotavirus vaccine when E.E.D. was presented to the ER on November 9, 2014 with diarrhea and
abdominal distention. An x-ray showed multiple loops of distended small bowel with air-fluid
levels consistent with small bowel obstruction. Surgery was performed to release a kink of the
terminal ileum 5 cm proximal to the ileocecal valve and to evaluate the entire small bowel with
no other abnormalities found. Specifically, “[t]hey did not find an intussusception.” Resp. Ex. A
at 3; Resp. Ex. K at 2; Pet. Ex. 6 at 2073. E.E.D. also tested positive for enterovirus and
rhinovirus, which was most likely the cause of his diarrhea. Resp. Ex. A at 2; Resp. Ex. K at 2-3;
Pet. Ex. 6 at 2047. He noted that E.E.D.’s symptoms were not consistent with the classic triad of
intussusception. Resp. Ex. K at 2-3. Abdominal ultrasound performed on November 10, 2014
revealed “numerous loops of fluid-filled dilated bowel in the abdomen without intussusception.”
Resp. Ex. A at 2; Pet. Ex. 6 at 2060. A CT performed on November 14, 2014 showed the same.
Id.
E.E.D. continued to have persistent abdominal distention, sepsis, and bloody stools, he
required another abdominal surgery on November 23, 2014. Resp. Ex. A at 2. The operative
report for that surgery documented extensive lesions throughout the abdomen involving
primarily the small bowel except for the very first 10 cm or so of the jejunum beyond the
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ligament of Treitz which was normal, thin-walled, and without adhesions. The remainder of the
small bowel had thick, indurated, hyperemic dense adhesions in numerous places. Enterotomy
was made in the mid ileum during adhesiolysis, and the surgeon noted blood-tinged fluid.
Utilizing the enterotomy and a colotomy in the rectosigmoid, an on-table enteroscopy was
performed on the entire colon and small bowel. There was an area of bright colored blood
without active bleeding. The rest of the bowel was normal. There was no Meckel’s diverticulum
or intussusception noted. Resp. Ex. A at 2; Pet. Ex. 6 at 2069. E.E.D. remained hospitalized until
December 22, 2014 requiring significant hospital support, close observation, and antibiotics.
Between December 22, 2014 and December of 2015, he had multiple hospitalizations for bowel
obstruction status post ileostomy and re-anastomosis, multiple PICC line infections, RSV, and C.
difficile requiring two fecal transplants. He was diagnosed with Hirschsprung’s disease requiring
aggressive medical therapy. Resp. Ex. A at 2-3.
Based on his clinical experience with intussusception, the medical records, and literature,
Dr. Liacouras opined that there is no evidence that E.E.D. suffered an intussusception nor was he
diagnosed with intussusception. Resp. Ex. A at 3.
Dr. Liacouras distinguished a “kink” or bowel obstruction from intussusception. He
explained that a “kink in the bowel” refers to a mechanic abnormality involving an anatomical
twist or compression of the intestines. Resp. Ex. N at 3. Bowel obstructions have many causes
including viral illness, adhesions, and NEC to name a few. Resp. Ex. K at 3. Medical literature
has demonstrated that kinks in the bowel have no relationship to intussusception. Resp. Ex. N at
3; Resp. Ex. P;41 Resp. Ex. Q;42 Resp. Ex. R;43 Resp. Ex. S;44 Resp. Ex. T;45 Resp. Ex. U.46 An
intussusception, on the other hand, is an acute emergent condition in which the bowel prolapses
within itself. Resp. Ex. A at 4. It is common between 4 months to 2 years of age, but its cause is
unknown. Children with intussusception usually present with a “triad” of symptoms which
include severe abdominal pain, vomiting, and currant jelly stools. Intussusception is diagnosed
by ultrasound, CT scan, or barium enema and initially treated with air, water, or contrast enema.
Surgery is rarely required. Where surgery is required, intussusception—if present—would
always be identified and corrected. Resp. Ex. A at 4, 5-6; Resp. Ex. K at 2-3.
While intussusception can cause a bowel obstruction, there was no clinical, radiological,
or surgical evidence in this case to support an intussusception. Rather, E.E.D. suffered a
mechanical “kink” in his intestine causing obstruction, more likely than not related to his many
gastrointestinal issues that predated his receipt of the Rotavirus vaccination. Resp. Ex. A at 6;
41 Pierre Munier et al., Bidirectional Jejunojejunal Anastomosis Prevents Early Small Bowel Obstruction Due to the
Kinking After Closure of the Mesenteric Defect in the Laparoscopic Roux-en-Y Gastric Bypass, 28 OBESITY
SURGERY 1838 (2018), filed as “Resp. Ex. P”.
42 Zana Alattar et al., Proximal Small Bowel Obstruction in a Patient with Cystic Fibrosis: A Case Report, 5
SURGICAL CASE REPORTS 143 (2019), filed as “Resp. Ex. Q”.
43 K.H. Ng, F.R.C.S. et al., Obstructive Complications of Laparoscopically Created Defunctioning Ileostomy, 51
DISEASES OF THE COLON & RECTUM 1664 (2008), filed as “Resp. Ex. R”.
44 Hisato Osada et al., Multidetector CT Appearance of Adhesion-Induced Small Bowel Obstructions: Matted
Adhesions Versus Single Adhesive Bands, 30 JAPANESE J. RADIOLOGY 706 (2012), filed as “Resp. Ex. S”.
45 Mesut Sipahi et al., Intestinal Malrotation: A Rare Cause of Small Intestinal Obstruction, 2014 CASE REPORTS IN
SURGERY 453128 (2014), filed as “Resp. Ex. T”.
46 de Vries et al., supra note 5.
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Resp. Ex. K at 3; Resp. Ex. N at 2-3. Surgery on November 9, 2014 revealed “kinking” of the
small bowel that was normal when the intestine was unkinked. Resp. Ex. A at 6. After surgery,
his gastrointestinal symptoms continued and required a second surgery two weeks later, at which
time multiple adhesions and inflammation were found. Resp. Ex. K at 3. None of the imaging
performed showed any evidence of intussusception, nor was intussusception identified at any
point during two surgical procedures. Id. at 4. Thus, he disagreed with Dr. Santoro’s
characterization of the “kinking” of the small bowel as “remnants of an intussusception”. Resp.
Ex. A at 5.
Dr. Liacouras explained that E.E.D. was born with several conditions that could have
caused the small bowel obstruction. He had prior abdominal surgery related to severe GERD,
NEC, and Cri-du-Chat. Resp. Ex. A at 5; Resp. Ex. K at 3; Resp. Ex. N at 1-2; Resp. Ex. O.47
His prior surgery likely caused him to develop abdominal adhesions, which also could have
caused his bowel obstruction. Resp. Ex. A at 4, 5-6; Resp. Ex. J;48 Resp. Ex. N at 1-2. Dr.
Liacouras concluded that E.E.D.’s small bowel obstruction was likely secondary to adhesions
and ischemia from either the NEC or the Nissen fundoplication surgery he had during his first
month of life. Resp. Ex. A at 4.
Dr. Liacouras detailed the inaccuracies in Dr. Santoro’s conclusions. First, E.E.D. did not
have intussusception. Dr. Santoro presumed E.E.D. had intussusception but radiographic studies,
including ultrasound and CT, as well as two surgeries never resulted in a finding or diagnosis of
intussusception. Further, Dr. Santoro’s reliance on Aydin was misplaced because the patient
discussed in Aydin was diagnosed with intussusception by ultrasound at the time of surgery.
Resp. Ex. A at 5. He acknowledged that ultrasound or CT scans are the “gold standard” to
diagnose intussusception but explained that those tests were unnecessary in this case because the
plain abdominal x-ray showed the small bowel obstruction. Therefore, no additional testing was
necessary. Resp. Ex. K at 1-2.
He further submitted that Dr. Santoro ignored E.E.D.’s medical history prior to his
receipt of the vaccination, including several severe gastrointestinal disorders. Resp. Ex. A at 5;
Resp. Ex. K at 1. Dr. Santoro further neglected to mention the adhesions found during the
November 23, 2014 surgical procedure, which were more likely a complication of his NEC or
secondary to the Nissen fundoplication and gastrostomy tube placement, both occurring prior to
his vaccination. Resp. Ex. A at 6. Dr. Liacouras disagreed with Dr. Santoro’s assertion that
laparoscopic fundoplication with gastrostomy placement would not cause adhesions or be
associated with the bowel obstruction, stating that the procedure has decreased complications of
adhesion formation, but it still occurs. Resp. Ex. K at 3; Resp. Ex. L.49
Dr. Liacouras disagreed that E.E.D.’s intussusception resolved spontaneously or was
reduced at the time of surgery, again pointing out that Dr. Santoro ignored the medical facts and
the findings of the treating physicians in this case, none of which include intussusception. Resp.
47 Paola Cerruti Mainardi et al., The Natural History of Cri du Chat Syndrome. A Report from the Italian Register,
49 European J. Medical Genetics 363 (2006), filed as “Resp. Ex. O”.
48 Muhammad S. Choudhry & Hugh W. Grant, Small Bowel Obstruction Due to Adhesions Following Neonatal
Laparotomy, 22 PEDIATRIC SURGICAL INT’L 729 (2006), filed as “Resp. Ex. J”.
49 Nwokoma et al., supra note 39.
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Ex. N at 2. Further, the details of the operative report of the surgery performed on November 9,
2014 show that the bowel obstruction was released upon the initial evisceration of the bowel
which freed the “kink” and released the obstruction, all of which occurred prior to “the running
of the bowel” as suggested by Dr. Santoro. Id.; Pet. Ex. 6 at 2073.
Dr. Liacouras argued all of Dr. Santoro’s opinions are based on assumptions not facts.
Even if E.E.D. did have intussusception on November 9, 2014, the findings revealed during the
November 23, 2014 surgery were consistent with NEC and were unrelated to intussusception.
Resp. Ex. A at 6; Resp. Ex. K at 3. Dr. Liacouras disagreed that intussusception was the cause of
E.E.D.’s NEC, noting that Hirokawa concluded that while the patient had both NEC and
intussusception, the intussusception was not the primary cause of the NEC. Resp. Ex. K at 3; Pet.
Ex. 29.50 Further, intussusception would not cause the extensive adhesions seen throughout the
vast majority of the abdomen during the November 23, 2014 surgery. Resp. Ex. K at 3. Still
further, the location of E.E.D.’s small bowel disease could not be caused by a single
intussusception but more likely was caused by NEC and his surgery prior to the vaccination. Id.
at 3-4.
In sum, Dr. Liacouras opined that E.E.D. did not have intussusception and his rotavirus
vaccination did not cause or contribute to his small bowel obstruction. He had Cri-du-Chat
syndrome, necrotizing enterocolitis, and severe GERD with secondary aspiration requiring
laparoscopic Nissen fundoplication prior to his vaccinations. Complications from these disorders
can cause abdominal distention, adhesions, mucosal abnormalities, and small bowel obstruction.
There is no evidence clinically or radiographically of an intussusception or any gastrointestinal
symptoms caused by the rotavirus vaccine. Resp. Ex. A at 6; Resp. Ex. K at 4; Resp. Ex. N at 4.
Further, there is no literature to support that a distal intussusception can cause multiple bowel
adhesions and/or focal bowel intestinal lesion in a different location which was found here. Resp.
Ex. K at 4; Resp. Ex. N at 3. The complicated medical conditions E.E.D. was born with also
resulted in his ongoing and worsening symptoms throughout his life. Resp. Ex. K at 4.
V. Legal Standard
A petitioner is required to establish their case by a preponderance of the evidence. 42
U.S.C. § 300aa-13(1)(a). The preponderance of the evidence standard requires a “trier of fact to
believe that the existence of a fact is more probable than its nonexistence before [they] may find
in favor of the party who has the burden to persuade the judge of the fact’s existence.” Moberly
v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d
867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is important
because a special master should not impose an evidentiary burden that is too high. Andreu v.
Sec’y of Health & Human Servs., 569 F.3d 1367, 1379-80 (Fed. Cir. 2009) (reversing a special
master’s decision that petitioners were not entitled to compensation); see also Lampe v. Sec’y of
Health & Human Servs., 219 F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Human
Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (disagreeing with the dissenting judge’s contention that
50 Hirokawa et al., supra note 18.
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the special master confused preponderance of the evidence with medical certainty). At the same
time, mere conjecture or speculation is insufficient under a preponderance of evidence standard.
Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984).
The Vaccine Act provides two avenues for petitioners to receive compensation. First, a
petitioner may demonstrate a “Table” injury—i.e., an injury listed on the Vaccine Injury Table
that occurred within the provided time period. 42 U.S.C. § 300aa-11(c)(1)(C)(i). “In such a case,
causation is presumed.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320
(Fed. Cir. 2006); see § 13(a)(1)(B). Second, where the alleged injury is not listed on the Vaccine
Injury Table, a petitioner may demonstrate an “off-Table” injury, which requires that the
petitioner “prove by a preponderance of the evidence that the vaccine at issue caused the injury.”
Capizzano, 440 F.3d at 1320; see § 11(c)(1)(C)(ii); see also Wright v. Sec’y of Health & Human
Servs., 22 F.4th 999, 1006 (Fed. Cir. 2022) (defining the term “residual effects” in the Act, as
“detrimental conditions within the patient, such as lingering or recurring signs and symptoms” of
the alleged vaccine injury, which are compensable). A petitioner need not show that the
vaccination was the sole cause, or even the predominant cause, of the alleged injury; showing
that the vaccination was a “substantial factor” and a “but for” cause of the injury is sufficient for
recovery. Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006);
Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). Petitioners
are not required “to eliminate alternative causes as part of establishing [their] prima facie case.”
Doe v. Sec’y of Health & Human Servs., 601 F.3d 1349, 1357-58 (Fed. Cir. 2010); see Walther v.
Sec’y of Health & Human Servs., 485 F.3d 1146, 1152 (Fed. Cir. 2007) (holding that a
“petitioner does not bear the burden of eliminating alternative independent potential causes”).
Once a petitioner has proven causation by preponderant evidence, “the burden then shifts to the
respondent to show by a preponderance of the evidence that the injury is due to factors unrelated
to the administration of the vaccine.” Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human
Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013) (citing 42 U.S.C. § 300aa-13(a)(1)(B)).
To prove causation, a petitioner must satisfy the three-pronged test established in Althen
v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen requires that a
petitioner show by preponderant evidence that a vaccination they received caused their 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. Together, these prongs must show “that the vaccine was ‘not only a but-for cause of the
injury but also a substantial factor in bringing about the injury.’” Stone v. Sec’y of Health &
Human Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012) (quoting Shyface, 165 F.3d at 1352-53).
Causation is determined on a case-by-case basis, with “no hard and fast per se scientific or
medical rules.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994).
Petitioners are not required to identify “specific biological mechanisms” to establish causation,
nor are they required to present “epidemiologic studies, rechallenge, the presence of pathological
markers or genetic disposition, or general acceptance in the scientific or medical communities.”
Capizzano, 440 F.3d at 1325 (quoting Althen, 418 F.3d at 1280). “[C]lose calls regarding
causation are resolved in favor of injured claimants.” Althen, 418 F.3d at 1280.
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Each Althen prong requires a different showing. Under the first prong, a petitioner 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 (citation omitted). To satisfy this prong, a
petitioner’s “theory of causation must be supported by a ‘reputable medical or scientific
explanation.’” Andreu, 569 F.3d at 1379 (quoting Althen, 418 F.3d at 1278). This theory need
only be “legally probable, not medically or scientifically certain.” Id. at 1380 (emphasis omitted)
(quoting Knudsen, 35 F.3d at 548). Nevertheless, “petitioners [must] proffer trustworthy
testimony from experts who can find support for their theories in medical literature.” LaLonde v.
Sec’y of Health & Human Servs., 746 F.3d 1334, 1341 (Fed. Cir. 2014).
The second Althen prong requires proof of a “logical sequence of cause and effect.”
Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1278). Even if the vaccination can
cause the injury, a petitioner must show “that it did so in [this] particular case.” Hodges v. Sec’y
of Health & Human Servs., 9 F.3d 958, 962 n.4 (Fed. Cir. 1993) (citation omitted). “A reputable
medical or scientific explanation must support this logical sequence of cause and effect,” Id. at
961 (citation omitted), and “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,” Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1385 (Fed. Cir. 2015)
(quoting Andreu, 569 F.3d at 1375).
The third Althen prong requires that a petitioner establish a “proximate temporal
relationship” between the vaccination and the alleged injury. Althen, 418 F.3d at 1281. This
“requires preponderant proof that the onset of symptoms occurred within a timeframe for which,
given the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir.
2008). Typically, “a petitioner’s failure to satisfy the proximate temporal relationship prong is
due to the fact that onset was too late after the administration of a vaccine for the vaccine to be
the cause.” Id. However, “cases in which onset is too soon” also fail this prong; “in either case,
the temporal relationship is not such that it is medically acceptable to conclude that the
vaccination and the injury are causally linked.” Id.; see also Locane v. Sec’y of Health & Human
Servs., 685 F.3d 1375, 1381 (Fed. Cir. 2012) (“[If] the illness was present before the vaccine was
administered, logically, the vaccine could not have caused the illness.”).
Finally, although this decision discusses some but not all the literature in detail, I have
reviewed and considered all of the medical records and literature submitted in this matter. See
Moriarty ex rel. Moriarty v. Sec’y of Health & Human 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 & Human 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).
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A. Law Regarding Diagnosis
In Broekelschen v. Sec’y of Health and Human Servs., 618 F.3d 1339, 1346 (Fed. Cir.
2010), the Federal Circuit recognized that in some circumstances, the special master may “first
determine which injury was best supported by the evidence in the record before applying the
Althen test.” This principle also means that a petitioner must establish that the vaccinee suffers
the injury allegedly linked to the vaccination. Lombardi v. Sec’y of Health & Human Servs., 656
F.3d 1343, 1353-54 (Fed. Cir. 2011).
V. Discussion
The outcome of petitioner’s case is dependent on a finding that E.E.D. suffered an
intussusception. Petitioner must first establish that intussusception was the appropriate diagnosis
of E.E.D.’s condition on November 9, 2014. Then, petitioner must present preponderant
evidence that the Rotavirus vaccine E.E.D. received on November 5, 2014 was the cause in fact
of his intussusception.
A. Diagnosis
The parties do not agree that E.E.D. suffered an intussusception. Petitioner alleges that
E.E.D. suffered an intussusception resulting from his November 5, 2014 Rotavirus vaccine.
Respondent agrees with the treating physicians and submits that E.E.D. had a small bowel
obstruction, which was more likely than not caused by factors unrelated to vaccination.
Focusing on E.E.D.’s medical history from the days following the subject vaccine, the
medical records show the following: E.E.D. was presented to the ER on November 9, 2014 with
a history of watery diarrhea that began around noon the day before. Pet. Ex. 6 at 2009-10. He
tested positive for enterovirus and rhinovirus and while in the ER and developed a sepsis-like
clinical presentation. Id. at 2050-52. His abdomen was distended. Id. at 2012. X-ray showed a
small bowel obstruction. Id. at 2013, 2029, 2034. “Exploratory laparotomy, release of small
bowel obstruction” was performed on that day. Id. at 2020-21. The operative report indicated
small bowel obstruction, with findings of terminal ileal obstruction. Id. at 2073. It also details the
procedure, stating that the bowel was eviscerated which released the bowel obstruction; there
were no adhesions but there was kinking at the terminal ileum about 5 cm proximal to the
ileocecal valve, which was released by pulling the bowel out of the abdomen. Id. Progress notes
documented a 3-month-old with a history of Cri-du-Chat, laryngomalacia, and gastrotomy with
fundoplication on October 2, admitted with bowel obstruction on November 9, 2014. Id. at 2145.
E.E.D.’s hospital course thereafter was complicated. He continued to have abdominal
distension and on November 20, 2014 developed bloody stools. Pet. Ex. 6 at 2020, 2273.
Antibiotics were administered for suspected NEC. Id. at 2050. He underwent another laparotomy
on November 23, 2014, with on-table push enteroscopy of the entire colon and small bowel,
resection of the distal ileum with end ileostomy and ileal mucous fistula, as well as an incidental
appendectomy. The G-tube was converted to a 10 French Anderson nasogastric tube for
improved postoperative gastric decompression. Id. at 2068-69. The surgeons documented a 2-
month-old, status post-laparotomy for post-operative “bowel obstruction on November 9, 2014
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after remote history of fundoplication and gastrostomy. Persistent abdominal distention, sepsis
and development of bloody stools without identifiable etiology necessitated laparotomy.” Id.
There were findings of extensive adhesions throughout the entire abdomen involving primarily
the small bowel with the exception of the very first 10 cm or so of the jejunum beyond the
ligament of Treitz. The remainder of the small bowel had thick, indurated, hyperemic, dense
adhesions in places. Id. No findings of intussusception were noted. Id. at 2069-70. He was
discharged on December 22, 2014. Id.
The experts agreed that intussusception presents with a classic triad of symptoms,
including abdominal pain, vomiting, and currant jelly stool. Pet. Ex. 34 at 2; Resp. Ex. A at 4, 5-
6; Resp. Ex. K at 2-3. In support of his opinion that E.E.D. suffered an intussusception, Dr.
Santoro described E.E.D.’s symptoms following receipt of the Rotavirus vaccine as severe pain,
lethargy, and significant rectal bleeding (hematochezia), in addition to having feeding difficulty
and GERD symptoms. Pet. Ex. 17 at 10; Pet. Ex. 34 at 2-3. None of these symptoms were
documented anywhere in the record. When asked to address this, he argued that only one to two-
thirds of intussusception patients present with the “classic triad” of abdominal pain, vomiting,
and currant jelly stool. Pet. Ex. 34 at 2; Resp. Ex. D.51 Dr. Liacouras argued that E.E.D.’s
symptoms on November 9 were not consistent with intussusception but were consistent with
enterovirus and rhinovirus, both of which E.E.D. tested positive for during his hospital stay.
Resp. Ex. A at 2; Resp. Ex. K at 2-3.
The experts also agreed that the “gold standard” diagnostic test for intussusception is
ultrasound. Pet. Ex. 34 at 2; Pet. Ex. 36 at 2; Pet. Ex. 38 at 2-3; Resp. Ex. K at 1-2. Dr. Santoro
argued that the treating physicians failed to diagnose E.E.D.’s intussusception because an
ultrasound was not performed. Pet. Ex. 36 at 2; Pet. Ex. 38 at 3; Resp. Ex. K at 1-2. Dr.
Liacouras submitted that other diagnostic testing clearly showed a small bowel obstruction so
further diagnostic testing—namely an ultrasound—was not required. Resp. Ex. K at 1-2.
Dr. Liacouras further argued that intussusception “is always found during a surgical
procedure”; here, no intussusception was found during E.E.D.’s surgery on November 9. Resp.
Ex. A at 6; Resp. Ex. K at 4. Dr. Santoro contended that the intussusception was not found
during the November 9 surgery because it had spontaneously resolved prior to surgery but would
have been seen on ultrasound if it had been performed. He then argued the “kinking” of the distal
bowel represented remnants of the intussusception just proximal to the ileocecal valve which was
not diagnosed because of the insensitivity of x-rays in diagnosing intussusception. Pet. Ex. 17 at
10; Pet. Ex. 34 at 2; Pet. Ex. 38 at 2-3. Dr. Liacouras disagreed with this explanation, stating that
a “kink” in the bowel and intussusception are not the same. Intussusception is a “telescoping” of
the intestine, while a “kink in the bowel” refers to a mechanically abnormal anatomical twist or
compression of the intestines. Resp. Ex. A at 6-7; Resp. Ex. N at 2-3. Literature has
demonstrated that kinks in the bowel have no relationship to intussusception. Resp. Ex. N at 3.
He again pointed out that two procedures were performed, neither of which showed evidence of
intussusception. Resp. Ex. K at 4.
The evidence submitted in this matter shows that a small bowel obstruction is not
equivalent to an intussusception. Intussusception is where one part of the intestine folds into
51 Carty, supra note 35.
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itself, much like when the smaller part of a telescope collapses into the larger part of the
telescope when it is closed. Pet. Ex. 28 at 2; Pet. Ex. 35 at 2;52 Pet. Ex. 37 at 5;53 Resp. Ex. H at
2-3.54 A small bowel obstruction or kink, on the other hand, is where there is a twist or
compression of the intestine. Resp. Ex. N at 3. While an intussusception may result in a small
bowel obstruction, none of the evidence submitted stated that a small bowel obstruction could
result in an intussusception. Resp. Ex. H at 2.
E.E.D.’s symptoms as documented in the medical records, imaging results, and
observations during surgery do not support that E.E.D. had an intussusception on November 9,
2014. Rather, the evidence as a whole shows that E.E.D. had a small bowel obstruction.
E.E.D.’s medical records show that he was presented to the ER on November 9, 2014 for
one day of watery, non-bloody stools and a concern for dehydration. There was no report of
severe abdominal pain, vomiting, or currant jelly stool. He tested positive for enterovirus and
rhinovirus, either of which could explain his symptoms. Pet. Ex. 6 at 2009-10, 2050-52. An x-ray
performed while in the ER showed a small bowel obstruction requiring surgery. Id. at 2013. It
was noted that enterovirus was “[l]ikely the cause of his ileus/SBO”. Id. at 2503. The findings
during the exploratory laparotomy done that day were consistent with a kink in the small bowel
at the terminal ileum that was easily reduced. Id. at 2020-21.
E.E.D. then developed NEC, abdominal distention, sepsis, and bloody stools, and he
required another surgery performed on November 23, 2014. Pet. Ex. 6 at 2068-69. The surgeons
documented a 2-month-old, status post-laparotomy for post-operative “bowel obstruction on
November 9, 2014 after remote history of fundoplication and gastrostomy. Persistent abdominal
distention, sepsis and development of bloody stools without identifiable etiology necessitated
laparotomy.” Id. There were findings of extensive adhesions throughout most of the abdomen
involving primarily the small bowel. Id. No findings of intussusception were noted. Id. at 2069-
70.
It is my responsibility to make credibility determinations in assessing the probative value
of witness opinion and the evidence filed in a case. See Porter v. Sec’y of Health & Human
Servs., 663 F.3d at 1242, 1250 (Fed. Cir. 2011) (“[T]his court has unambiguously explained that
special masters are expected to consider the credibility of expert witnesses in evaluating petitions
for compensation under the Vaccine Act.”). Dr. Liacouras provided a higher degree of expertise
within pediatric gastroenterology and paid more attention to the details of E.E.D.’s medical
records both before and after the vaccination in rendering his opinions, thereby making his
opinions far more compelling than Dr. Santoro’s.
Not only did I find Dr. Liacouras to be a more credible witness given his expertise, I also
found that Dr. Santoro’s opinions lacked foundation or support in the record. Dr. Santoro’s
opinion was that the intussusception was simply missed during imaging and spontaneously
resolved prior his surgery on November 9, 2014. This opinion is inconsistent with the symptoms
E.E.D. presented with, the findings on x-ray, and the findings during the exploratory laparoscopy
52 Applegate, supra note 10.
53 Kelly, supra note 6.
54 Jain & Haydel, supra note 7.
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on November 9. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 118 S. Ct. 512, 139 L. Ed. 2d 508
(1997); Snyder ex rel. Snyder v. Sec'y of Health & Human Servs., 88 Fed. Cl. 706 (2009) (“ . . .
nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit
opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court
may conclude that there is simply too great an analytical gap between the data and the opinion
proffered.”).
Further, Dr. Liacouras’ opinion that E.E.D. suffered a small bowel obstruction—not an
intussusception—was consistent with the opinions of his treating providers. The opinions of
E.E.D.’s treaters are entitled to some weight on the issue of diagnosis. It has been noted that
treater opinions are generally important in evaluating if preponderant evidence supports one
diagnosis over an alternative. Strong v. Sec’y of Health & Human Servs., No. 15–1108V, 2018
WL 1125666, at *20 (Fed. Cl. Spec. Mstr. Jan. 12, 2018) (internal citations omitted). Not only
were the treating providers able to observe E.E.D. at the time he suffered these symptoms, but
they also had the benefit of seeing inside E.E.D.’s abdomen during two surgical procedures. At
no point was E.E.D. diagnosed with an intussusception by any of his treating providers, nor was
the possibility of intussusception even raised anywhere in the medical records.
In sum, E.E.D. presented on November 9 with diarrhea and concern for dehydration—not
any of the classic triad of symptoms associated with intussusception. Based on his clinical
presentation, an x-ray was ordered. While the literature supports that ultrasound is the preferred
diagnostic tool for intussusception, Carty wrote that “[o]nce a clinical diagnosis of obstruction is
made and confirmed by plain radiographs, further investigation is not indicated.” Resp. Ex. D at
8.55 Thus, an ultrasound was not necessary here because the x-ray showed clear evidence of an
obstruction that required surgery. Pet. Ex. 6 at 2029, 2034. Further, Dr. Liacouras explained that
if an intussusception is present, it will be observed during surgery. Resp. Ex. A at 6. Here, the
operative notes from the November 9 surgery do not document an intussusception. Pet. Ex. 6 at
2073. Finally, E.E.D.’s treaters agreed with the diagnosis of small bowel obstruction, for which
he was treated; none of his providers documented any concern for an intussusception. Id. at
2029, 2034, 2503.
Based on the foregoing, there is not preponderant evidence in this case to support a
finding the E.E.D. suffered an intussusception on November 9, 2014. Instead, the evidence
supports a small bowel obstruction.
B. Althen Analysis
As noted above, for petitioner to prevail on an “off-Table” claim, she must show by
preponderant evidence that the claimed injury resulted from the vaccination at issue. Capizzano,
440 F.3d at 1320. Doing so shifts the burden to respondent to show that the injury was caused by
factors unrelated to the vaccination. Deribeaux, 717 F.3d at 1367.
Presenting a sound and reliable theory is essential to petitioner’s case. A theory causally
connecting the vaccine to the injury is the first Althen prong. When petitioner fails to establish
this element, compensation is denied. Boatmon v. Sec’y of Health & Human Servs., 941 F.3d
55 Carty, supra note 35.
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1351, 1360-62 (Fed. Cir. 2019). Moreover, the theory advanced for Althen prong one influences
the remaining two Althen prongs. For the second Althen prong, which addresses whether a
logical sequence connects the vaccine to the injury, special masters may consider whether the
vaccinee responded in a way consistent with the theory being offered. Hibbard v. Sec’y of Health
& Human Servs., 698 F.3d 1355, 1364 (Fed. Cir. 2012); Miller v. Sec’y of Health & Human
Servs., 172 Fed. Cl. 762, 784 (2024) (finding special master did not err in denying entitlement
when petitioner did not establish that she had immune complexes after asserting a theory
involving immune complexes); Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. 43, 52-57
(2013); La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 205 (2013), aff’d, 746
F.3d 1334 (Fed. Cir. 2014). Similarly, the third Althen prong, which concerns timing, depends at
least in part upon the theory being offered. Langland v. Sec’y of Health & Human Servs., 109
Fed. Cl. 421, 443 (2013); see also Koehn v. Sec’y of Health & Human Servs., 773 F.3d 1239,
1244-45 (Fed. Cir. 2014) (holding that special master was not arbitrary in finding an onset of
injury seven months after vaccination was incompatible with a theory based upon cytokines).
Without a defined theory, attempting to determine whether preponderant evidence supports the
logical sequence or timing is difficult if not impossible.
Petitioner’s causation theory is predicated on a finding that E.E.D. had an intussusception
and that his intussusception was caused by the Rotavirus vaccine. Dr. Santoro failed to proffer an
opinion as to how a rotavirus vaccine could cause a small bowel obstruction, adhesions, or NEC
in the absence of intussusception. Indeed, he only mentioned small bowel obstruction
incidentally as it can be caused by an intussusception. See generally Pet. Ex. 17; Pet. Ex. 34; Pet.
Ex. 36; Pet. Ex. 38. Likewise, with the exception of a single article related to Cri-du-Chat, all
literature Dr. Santoro relied upon was related to intussusception. Thus, my finding that E.E.D.
did not suffer an intussusception renders the issue of causation moot. “Because causation is
relative to the injury, a petitioner must provide a reputable medical or scientific explanation that
pertains specifically to the petitioner’s case, although the explanation need only be ‘legally
probable, not medically or scientifically certain.’” Broekelschen, 618 F.3d at 1345 (quoting
Knudsen, 35 F.3d at 548-49).
1. Petitioner Has Not Provided a Sound and Reliable Medical Theory
It is petitioner’s burden to prove a sound and reliable theory for how the vaccinations
received on November 5, 2014 can cause the injury alleged in this case. Pafford, 451 F.3d at
1355-56 (citation omitted). In other words, Dr. Santoro was required to provide a sound and
reliable theory for how the rotavirus vaccine (or any of the other vaccinations given on
November 5, 2014) caused a small bowel obstruction or “kink”, adhesions, and subsequent NEC
that required surgical intervention.
Even assuming arguendo that Dr. Santoro’s theory could be applied to bowel obstruction
without intussusception, it still fails. Dr. Santoro provided a detailed review of prior vaccinations
against rotavirus, stating they were associated with intussusception. Pet. Ex. 17 at 5-8. The
RotaShield vaccine was suspended shortly after it hit the market due to infants developing
intussusception after receiving it. Id. at 5. An investigation into this concern revealed that the risk
of intussusception increased 20-30 times over the expected risk for otherwise healthy infants
within two weeks following the first dose of the vaccine and 3-7 times over the expected risk
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following the second dose of the vaccine. Id. The manufacturer of the RotaShield vaccination
voluntarily withdrew it from the market. Id. at 6. Dr. Santoro provided no citations to support
this history.
Next, the Rotateq vaccine hit the market in 2006. In approximately one year on the
market, the FDA stated that 28 cases of intussusception were reported through VAERS in the
U.S. in infants who received the vaccine. Pet. Ex. 17 at 6. There have been an additional 584
confirmed intussusceptions after administration of the Rotateq vaccine as reported through
VAERS, demonstrating “a consistent relationship between the Rotateq vaccine and
intussusception from its introduction to the present.” Id.; Pet. Ex. 19.56
Finally, he discussed the Rotarix vaccine, which is the vaccine administered in this case.
Pet. Ex. 17 at 7. He submitted the package insert for the Rotarix vaccine, stating that no risk of
intussusception was observed in a pre-licensing study of 63,225 infants in Finland and Latin
America; however, post-marking observational studies in Mexico, Brazil, and Australia showed
a temporal association of 31 days between intussusception and the first dose of Rotarix, with a
clustering of cases in the first 7 days after vaccination. Id.; Pet. Ex. 20 at 5, 9-10.57
As a preliminary matter, VAERS reports and manufacturers’ package inserts are not
entitled to much weight in assessing causation. Though VAERS is an important monitoring tool,
its use in assessing causation is limited because anyone can report anything through VAERS, no
matter how attenuated, and it can only provide support for a temporal relationship. It is well
established that VAERS data does not prove causation. See, e.g., Sullivan v. Sec’y of Health &
Human Servs., No. 10–398V, 2015 WL 1404957, at *20 (Fed. Cl. Spec. Mstr. Feb. 13, 2015)
(“Because of their passive nature and unverified claims, VAERS reports are too anecdotal and
unscientific to have much probative value in establishing a causation theory”); Tompkins v. Sec'y
of Health & Human Servs., No. 10–261V, 2013 WL 3498652, at *16 (Fed. Cl. Spec. Mstr. June
21, 2013), review denied sub nom., Tompkins v. United States, 117 Fed. Cl. 713 (2014). Even the
study Dr. Santoro provided acknowledges that “VAERS generally cannot assess causality of an
adverse event after vaccination”. Pet. Ex. 19 at 2.
Further, in a leading case discussing the evidentiary weight of package inserts, one
special master went so far as to declare that “federal regulations specifically preclude the
contents of drug product labels, as reproduced in the [Physician’s Desk Reference], from serving
as admissions regarding causation.” Werderitsch v. Sec’y of Health & Human Servs., No. 99-
319V, 2005 WL 3320041, at *8 (Fed. Cl. Spec. Mstr. Nov. 10, 2005). Relying upon regulations
found at 21 C.F.R. § 600.80, Werderitsch reasoned that because the Food and Drug
Administration requires manufacturers to list adverse occurrences regardless of causality, the
listing of an event on a product insert does not support a finding of causation. Id.; see also
Salerno v. Sec’y of Health & Human Servs., No. 16-1280, 2020 WL 344163, at *13 (Fed. Cl.
Spec. Mstr. May 29, 2020); Bender v. Sec’y of Health & Human Servs., No. 11-693V, 2018 WL
3679637, at *31 (Fed. Cl. Spec. Mstr. July 2, 2018) (noting that “vaccine package inserts do not
constitute causation evidence meriting significant weight”), mot. for rev. denied, 141 Fed. Cl.
262 (2019); Coppola v. Sec’y of Health & Human Servs., No. 09-631V, 2012 WL 1118849, at
56 Haber et al., supra note 24.
57 GlaxoSmithKline, supra note 25.
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*26 (Fed. Cl. Spec. Mstr. Mar. 7, 2012) (rejecting a petitioner’s reliance on vaccine package
insert information as indicative of alleged vaccine causation).
Dr. Santoro further relied on a mouse study that showed that rotavirus infection increased
serum tumor necrosis factor alpha and gamma interferon cytokine levels after lipopolysaccharide
induction, suggesting that the rotavirus infection and live vaccination could sensitize mice to the
inflammatory effect of subsequent LPS treatment, thereby enhancing intussusception rates in
mice. Pet. Ex. 17 at 9; Pet. Ex. 27.58 While the authors found an elevation in intussusception
rates in mice given both rotavirus and LPS compared to LPS alone, they noted that “[t]he failure
of rotavirus infection without LPS administration to induce intussusception in mice suggests that
either rotavirus infection alone induced intussusceptions at a low rate that was not detectable in
our studies, at different times than we examined, or that it was important in, but not sufficient to
cause, intussusception.” Pet. Ex. 27 at 6-7 (emphasis added). Thus, this article does not support
that rotavirus infection by itself plays any role in intussusception.
In another study relied on by Dr. Santoro, the authors found an increase in distal ileal
wall thickness and lymphadenopathy during acute infection with rotavirus, suggesting “a
plausible mechanism by which rotavirus infection could cause intussusception.” Pet. Ex. 17 at 9;
Pet. Ex. 28.59 However, Dr. Santoro failed to explain what role distal ileal wall thickness plays in
intussusception or why the findings of this study involving infection were applicable here when
discussing rotavirus vaccination. Notably, the authors stated that their findings related to
rotavirus infection were consistent with prior studies that concluded adenovirus may affect the
bowel wall, but the “role [of infections] in inducing intussusception remains unclear.” Pet. Ex. 28
at 4. Thus, there is a gap in Dr. Santoro’s theory, rendering it unpersuasive. See Langland v.
Sec’y of Health & Human Servs., 109 Fed. Cl. 421, 441 (2013) (stating that a persuasive medical
theory “may require an explanation of the steps by which the vaccination was believed to result
in the harm”).
Dr. Santoro cited to a case report of a premature infant with intussusception associated
with NEC, submitting that mesenteric and enteric vascular ischemia could be a trigger of
intussusception in neonates. Pet. Ex. 17 at 10; Pet. Ex. 29.60 In reviewing the case report, the
authors observed the possibility that NEC triggered intussusception—not the other way around.
Pet. Ex. 29 at 2. Thus, the case report does not support Dr. Santoro’s argument that an
intussusception caused by a rotavirus vaccine could in turn cause NEC that requires surgical
intervention.
Even affording petitioner the benefit of the doubt that Dr. Santoro’s theory could be
applied to small bowel obstruction without the presence of an intussusception, Dr. Santoro failed
to explain how or by what mechanism vaccines in general or rotavirus vaccine specifically can
cause intussusception, bowel obstruction, adhesions, or NEC. Likewise, he provided no literature
to substantiate his threadbare theory that a rotavirus vaccine could cause any of the
aforementioned injuries. The literature he cited only discusses rotavirus vaccination or infection
associated temporally with intussusception. While petitioners are not required to demonstrate a
58 Warfield et al., supra note 31.
59 Robinson et al., supra note 8.
60 Hirokawa et al., supra note 18.
26

Case 1:17-vv-01648-UNJ Document 77 Filed 04/21/25 Page 27 of 31
“specific biological mechanism”, they “must proffer trustworthy testimony from experts who can
find support for their theories in medical literature in order to show causation”. LaLonde, 746
F.3d at 1341; see also Snowbank Enter., 6 Cl. Ct. at 486; Moberly, 592 F.3d at 1322; de Bazan,
539 F.3d at 1351.
Accordingly, petitioner has failed to present a sound and reliable theory for how the
Rotarix vaccine can cause intussusception (which E.E.D. did not suffer), a bowel obstruction or
“kink”, bowel adhesions, and/or NEC.
2. Petitioner Has Failed to Demonstrate a Logical Sequence of Cause and Effect as
well as Proximate Temporal Relationship
Having failed to prove that E.E.D. suffered the injury alleged as well as a sound and
reliable causation theory, the remainder of petitioner’s claim necessarily fails. But for the sake of
thoroughness, the remaining prongs will be briefly addressed. Because petitioner’s arguments
regarding prongs two and three significantly overlap, the prongs will be analyzed concurrently.
As with prong one, I will assume for the sake of argument that petitioner’s theory can be
accurately applied to a small bowel obstruction and not just an intussusception.
To satisfy prongs two and three, petitioner must demonstrate by preponderant evidence
that the vaccination(s) did cause the injury alleged and that the onset of symptoms related to their
injury occurred within a medically reasonable timeframe to infer causation. Hodges v. Sec’y of
Health & Human Servs., 9 F.3d 958, 962 n.4 (Fed. Cir. 1993) (citation omitted); de Bazan, 539
F.3d at 1352.
Dr. Santoro submitted that the rotavirus vaccine can cause an intussusception within
seven days of its administration, which occurred here because E.E.D. received the subject
vaccine on November 5 and suffered an intussusception three days later. He further opined that
E.E.D.’s intussusception caused NEC which was surgically treated on November 23. Pet. Ex. 17
at 10-11.
In support of prong two, Dr. Santoro claimed that E.E.D. had not previously suffered an
intussusception or a small bowel obstruction and there were no other more likely causes of his
“presumed” intussusception. Pet. Ex. 17 at 7, 11; Pet. Ex. 34 at 3; Pet. Ex. 36 at 2-3. Further, he
opined that the “kink” observed during E.E.D.’s November 9 surgery “represented the remnants
of a resolved intussusception.” Pet. Ex. 38 at 2. He also opined that the intussusception caused
E.E.D.’s subsequent NEC, requiring surgery on November 23. Pet. Ex. 17 at 11. To support both
prongs two and three, Dr. Santoro argued that intussusception is most commonly seen within 7
days after rotavirus vaccination and E.E.D.’s intussusception occurred three days after his
vaccination. Id.; Pet. Ex. 20;61 Pet. Ex. 21;62 Pet. Ex. 25.63
Further, in support of prong two, Dr. Santoro submitted a study that demonstrated an
increase in distal ileal wall thickness and lymphadenopathy during rotavirus infection. Pet. Ex.
61 GlaxoSmithKline, supra note 25.
62 Patel et al., supra note 26.
63 Koch et al., supra note 11.
27

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17 at 9; Pet. Ex. 28.64 Dr. Santoro pointed out that the November 23 surgery showed
inflammation, thickness, and bleeding in the distal small bowel. Pet. Ex. 17 at 10; Pet. Ex. 6 at
2068-70. However, Dr. Santoro failed to explain how distal ileal wall thickness leads to
intussusception. Thus, even though the medical records support that E.E.D.’s distal small bowel
was inflamed and thickened on November 23, it remains unclear how this relates to an
intussusception. Further, the case report he provided to show an association between
intussusception and NEC demonstrated only a one-way association, with NEC potentially
causing intussusception not the other way around. Pet. Ex. 17 at 10; Pet. Ex. 29 at 2 (“. . .
mesenteric enteric vascular ischemia may produce a stricture following recovery from NEC.
[One study] reported two possible cases of NEC evolving into intussusception . . . mesenteric
and enteric vascular ischemia (i.e., NEC) may be one trigger of intussusception in neonates.”).65
Thus, there is no evidence to support Dr. Santoro’s contention that the intussusception caused
E.E.D.’s NEC that necessitated surgery.
The remaining arguments in support of prongs two and three rely exclusively on temporal
association. Pet. Ex. 17 at 7-8, 11; Pet. Ex. 20;66 Pet. Ex. 21;67 Pet. Ex. 25;68 Pet. Ex. 34 at 3; Pet.
Ex. 36 at 2-3. It is clearly established that temporal proximity alone is insufficient to prove
causation. Moberly, 592 F.3d at 1323; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144,
1148 (Fed. Cir. 1992).
Therefore, even assuming that Dr. Santoro’s theory regarding intussusception can be
accurately applied to small bowel obstruction, I do not find it persuasive in proving either prongs
two or three. At most, Dr. Santoro demonstrated a temporal relationship between intussusception
and rotavirus vaccination. Although a proximate temporal relationship is part of the causation
analysis, it alone is insufficient to meet petitioner’s burden.
Despite Dr. Santoro’s contentions, E.E.D. was unfortunately born with several conditions
that could have caused his small bowel obstruction. I recognize that petitioner is not required to
eliminate alternative causes to prove her prima facie case, but I would be remiss to not address
the potential alternative causes in this case. Stone, 676 F.3d at 1379-80 (“Our decisions support
the commonsense proposition that evidence of other possible sources of injury can be relevant
not only to the ‘factors unrelated’ defense, but also to whether a prima facie showing has been
made that the vaccine was a substantial factor in causing the injury in question.)”; de Bazan, 539
F.3d at 1353 (“The government, like any defendant, is permitted to offer evidence to demonstrate
the inadequacy of the petitioner's evidence on a requisite element of the petitioner's case-in-
chief.”). In doing so, I also note that even without considering alternative cause(s), petitioner has
failed to sustain her burden.
Importantly, Dr. Santoro failed to address E.E.D.’s prior medical history, even after he
was explicitly ordered to do so. ECF No. 38. He disregarded the extensive, similar medical
problems E.E.D. continued to suffer in the years following the 2014 hospitalization. He
64 Robinson et al., supra note 8.
65 Hirokawa et al., supra note 18.
66 GlaxoSmithKline, supra note 25.
67 Patel et al., supra note 26.
68 Koch et al., supra note 11.
28

Case 1:17-vv-01648-UNJ Document 77 Filed 04/21/25 Page 29 of 31
concentrated only on that which would support his opinion that E.E.D. suffered an
intussusception resulting from a rotavirus vaccination, which was contrary to the medical record
and findings of the treating physicians. Because Dr. Santoro was dismissive of, ignored and/or
failed to address E.E.D.’s significant health issues, I afforded greater weight to the opinions of
Dr. Liacouras. See Porter, 663 F.3d at 1250.
Dr. Liacouras explained that adhesions can cause a small bowel obstruction. In fact,
adhesions are the leading cause of small bowel obstructions, with approximately 85% of
adhesive small bowel obstructions caused by postoperative adhesions. Resp. Ex. S at 1.69
The operative report from November 23, 2014 documented “extensive adhesions”
throughout the abdomen involving primarily the small bowel with “thick, indurated, hyperemic
dense adhesions”. Pet. Ex. 6 at 2068-70. Pneumatosis, which is a feature of NEC, was observed
endoscopically and is not a complication of reducible intussusception. Resp. Ex. N at 3. Further,
intussusception does not cause extensive adhesions throughout the entire abdomen. More likely,
those findings resulted from NEC and prior surgery occurring prior to E.E.D.’s receipt of the
subject vaccination. Id.; Resp. Ex. K at 3-4. Further, there is no literature to support that a distal
intussusception can cause multiple bowel adhesions and/or focal intestinal lesion in a different
location. Resp. Ex. K at 4.
There are several reasons to believe E.E.D.’s adhesions were related to his medical issues
before vaccination. He was born with Cri-du-Chat, which often presents with gastroesophageal
reflux that requires abdominal surgery. Dr. Liacouras cited literature discussing adhesions as part
of the normal healing process following laparotomy. Resp. Ex. J at 1 (in a retrospective study of
414 babies who underwent transabdominal procedures in the weeks after birth, 23 or 6% had re-
operations for small bowel obstructions due to adhesions, with four of those patients having
further adhesive obstructions requiring surgery);70 Resp. Ex. L at 2 (noting that 65-90% of
patients with adhesive obstruction had undergone previous abdominal surgery whereas only 10-
28% had no previous surgery).71 E.E.D. had his first abdominal surgery on October 2, 2014 and
a second abdominal surgery on November 9, 2014. Pet. Ex. 6 at 40, 2020-21. Dr. Santoro
disagreed that E.E.D.’s small bowel obstruction was caused by adhesions that formed after his
first surgery, arguing that adhesions only form after open abdominal surgery and E.E.D. had a
laparoscopic fundoplication with gastrostomy placement. Further, the prior surgery was in the
upper abdomen, not the lower abdomen where the obstruction occurred. Pet. Ex. 34 at 2-3; Pet.
Ex. 36 at 2; Resp. Ex. L; Resp. Ex. M.72 Dr. Liacouras agreed with Dr. Santoro that laparoscopic
procedures produce fewer adhesions than open procedures, but he argued adhesions still occur in
laparoscopic procedures. Resp. Ex. A at 5; Resp. Ex. K at 3; Resp. Ex. L; Resp. Ex. J; Resp. Ex.
M at 3.
A laparoscopic Nissen fundoplication uses five trocars, one with the camera placed
supra-umbilically and the other four placed in a semicircle beneath the costal arch.73 Thus, there
69 Osada et al., supra note 44.
70 Choudhry & Grant, supra note 48.
71 Nwokoma et al., supra note 39.
72 Polymeneas et al., supra note 40.
73 Wenliang Chen & David W. Rattner, Laparoscopy and Laparotomy, in TEXTBOOK OF GASTROENTEROLOGY
29

Case 1:17-vv-01648-UNJ Document 77 Filed 04/21/25 Page 30 of 31
are five entry points—not limited to the upper abdomen as argued by Dr. Santoro. The following
image illustrates the entry points for laparoscopic fundoplication:
The experts agreed that the findings from the November 23, 2014 surgery were consistent
with NEC. Dr. Liacouras explained that NEC can cause adhesion formation, and inflammatory
processes that tend to result in denser adhesions. Resp. Ex. N at 2; Resp. Ex. J at 3, 4.74 Dr.
Santoro argued that NEC was “caused or precipitated by the small bowel obstruction and
intussusception”. Pet. Ex. 17 at 11; Pet. Ex. 30;75 Pet. Ex. 34 at 3. Dr. Liacouras argued the
adhesions were more likely a complication of E.E.D.’s prior NEC (diagnosed on September 4,
2014) or secondary to the Nissen fundoplication and gastrostomy tube placement (on October 2,
2014), both occurring well before his vaccination. Resp. Ex. A at 6; Pet. Ex. 6 at 40, 169. Dr.
Santoro never acknowledged that E.E.D. had NEC, a bowel obstruction or surgery shortly after
his birth, thus he failed to explain why he believed the adhesions seen during the November 23
surgery were unrelated to the NEC he was diagnosed with prior to receiving the vaccine.
Finally, according to Dr. Liacouras, some viral illnesses have been demonstrated to cause
a small bowel obstruction. Resp. Ex. K at 3. When E.E.D. presented to the ER on November 9,
2014, he tested positive for enterovirus and rhinovirus. Pet. Ex. 6 at 2051.
Dr. Santoro failed to provide preponderant evidence that the rotavirus vaccine E.E.D.
received on November 5, 2014 was in any way related to his “presumed” intussusception, small
bowel obstruction, adhesions, or NEC requiring surgery. Dr. Liacouras, on the other hand,
presented persuasive, evidence-based arguments that E.E.D.’s small bowel obstruction was
caused by factors unrelated to the rotavirus vaccination. For the reasons explained above, I afford
greater weight to Dr. Liacouras’ opinions than to Dr. Santoro’s. I make no finding as to what
alternative cause is most supported by the evidence submitted because that is not relevant here as
petitioner failed to prove a prima facie case of causation. As such, petitioner has failed to satisfy
prongs two and three.
(Tadataka Yamada, 2009).
74 Choudhry & Grant, supra note 48.
75 Aydin, supra note 34.
30

Case 1:17-vv-01648-UNJ Document 77 Filed 04/21/25 Page 31 of 31
VI. Conclusion
While I extend my deepest condolences to the Derkach family on the loss of E.E.D.,
based on the evidence, I conclude that petitioner has not provided preponderant evidence that she
is entitled to compensation under the Vaccine Act. The Clerk shall enter judgment
accordingly.76
IT IS SO ORDERED.
s/ Mindy Michaels Roth
Mindy Michaels Roth
Special Master
76 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party filing a notice renouncing the
right to seek review.
31

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_17-vv-01648-cl-extra-11232579
Date issued/filed: 2025-12-29
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10765994
--------------------------------------------------------------------------------
     In the United States Court of Federal Claims
                                    OFFICE OF SPECIAL MASTERS
                                             No. 17-1648V
                                        Filed: December 4, 2025

* * * * * * * * * * * * *                         *   *
ALINA DERKACH,                                        *
as administrator and legal representative             *
of ESTATE OF E.E.D.,                                  *
                                                      *
                  Petitioner,                         *
                                                      *
v.                                                    *
                                                      *
SECRETARY OF HEALTH                                   *
AND HUMAN SERVICES,                                   *
                                                      *
          Respondent.                                 *
* * * * * * * * * * * * *                         *   *

Elizabeth M. Muldowney, Esq., Sands Anderson PC, Richmond, VA, for petitioner.
Emilie Williams, Esq., U.S. Department of Justice, Washington, DC, for respondent.

                         DECISION ON ATTORNEYS’ FEES AND COSTS 1

Roth, Special Master:

        On November 1, 2017, Alina Derkach (“petitioner”) filed a petition on behalf of her minor
child, E.E.D., pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §
300aa-10 et seq. (“Vaccine Act” or “the Program”). Petitioner ultimately alleged that the Rotarix,
Pediarix, and/or haemophilus influenza type B vaccines E.E.D. received on November 5, 2014,
resulted in E.E.D. suffering a bowel obstruction and/or intussusception. Amended Petition, ECF
No. 75. A decision issued on March 27, 2025, dismissing petitioner’s claim for failure to establish
by preponderant evidence that she was entitled to compensation. ECF No. 76.

        On July 2, 2025, petitioner filed the instant motion for attorneys’ fees and costs requesting
a total of $81,438.46, representing $67,796.70 in attorneys’ fees and $13,641.76 in costs. Motion

1
  Because this decision contains a reasoned explanation for the action taken in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims’ website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means
the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner
has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an
unwarranted invasion of privacy. If, upon review, the undersigned finds that the identified material fits within this
definition, such material will be redacted from public access.
for Fees, ECF No. 80. Respondent filed his response on August 1, 2025, advising he was satisfied
the statutory requirements for an award of fees and costs are met. Response, ECF No. 86.
Petitioner filed a reply that same day. Reply, ECF No. 87.

        This matter is now ripe for consideration.

                                       I.     Legal Framework

        The Vaccine Act permits an award of “reasonable attorneys’ fees” and “other costs.” §
15(e)(1). If a petitioner succeeds on the merits of his or her claim, the award of attorneys' fees is
automatic. Id.; see Sebelius v. Cloer, 133 S. Ct. 1886, 1891 (2013). However, a petitioner need not
prevail on entitlement to receive a fee award as long as the petition was brought in “good faith”
and there was a “reasonable basis” for the claim to proceed. § 15(e)(1). Here, because petitioner
was awarded compensation pursuant to a stipulation, she is entitled to a final award of reasonable
attorneys’ fees and costs.

        The Federal Circuit has endorsed the use of the lodestar approach to determine what
constitutes “reasonable attorneys' fees” and “other costs” under the Vaccine Act. Avera v. Sec’y of
Health & Hum. Servs., 515 F.3d 1343, 1349 (Fed. Cir. 2008). Under this approach, “an initial
estimate of a reasonable attorneys' fees” is calculated by “multiplying the number of hours
reasonably expended on the litigation times a reasonable hourly rate.” Id. at 1347–48 (quoting
Blum v. Stenson, 465 U.S. 886, 888 (1984)). That product is then adjusted upward or downward
based on other specific findings. Id.

        Special masters have substantial discretion in awarding fees and may adjust a fee request
sua sponte, apart from objections raised by respondent and without providing petitioners with
notice and opportunity to respond. See Sabella v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 201,
209 (2009). Special masters need not engage in a line-by-line analysis of petitioner's fee
application when reducing fees. See Broekelschen v. Sec’y of Health & Hum. Servs., 102 Fed. Cl.
719, 729 (2011).

                                            II.   Discussion

A.     Reasonable Hourly Rate

        A “reasonable hourly rate” is defined as the rate “prevailing in the community for similar
services by lawyers of reasonably comparable skill, experience and reputation.” Avera, 515 F.3d
at 1348 (quoting Blum, 465 U.S. at 896 n.11). In general, this rate is based on “the forum rate for
the District of Columbia” rather than “the rate in the geographic area of the practice of petitioner's
attorney.” Rodriguez v. Sec'y of Health & Hum. Servs., 632 F.3d 1381, 1384 (Fed. Cir. 2011)
(citing Avera, 515 F. 3d at 1349). There is a “limited exception” that provides for attorney's fees
to be awarded at local hourly rates when “the bulk of the attorney's work is done outside the forum
jurisdiction” and “there is a very significant difference” between the local hourly rate and forum
hourly rate. Id. This is known as the Davis County exception. See Hall v. Sec'y of Health & Hum.
Servs., 640 F.3d 1351, 1353 (2011) (citing Davis Cty. Solid Waste Mgmt. & Energy Recovery
Special Serv. Dist. v. U.S. EPA, 169 F.3d 755, 758 (D.C. Cir. 1999)).


                                                   2
        For cases in which forum rates apply, McCulloch provides the framework for determining
the appropriate hourly rate range for attorneys’ fees based upon the attorneys' experience. See
McCulloch v. Sec’y of Health & Hum. Servs., No. 09–293V, 2015 WL 5634323 (Fed. Cl. Spec.
Mstr. Sept. 1, 2015). The Office of Special Masters has accepted the decision in McCulloch and
has issued a Fee Schedule for subsequent years. 2

      Petitioner requests the following hourly rates on behalf of the attorneys and paralegals who
worked on this case:

    Name             2017 2018          2019      2020       2021      2022      2023       2024      2025
    Elizabeth        $353 $363          $370      $388       $408      $421      $450       $475      $510
    Muldowney                                                                    or         or
                                                                                 $186       $195
    Ramon            -       -          $405      -          -         -         -          -         -
    Rodriguez, III
    Paralegals       -       $149       $151      $158       $166      $177      -          $195      -

       These rates are consistent with what the attorneys and paralegals at the firm have
previously been awarded. See, e.g., Bodie v. Sec'y of Health & Hum. Servs., No. 19-1351V, 2025
WL 2650579 (Fed. Cl. Aug. 20, 2025); Barrows v. Sec'y of Health & Hum. Servs., No. 23-1653V,
2025 WL 2732878 (Fed. Cl. Aug. 20, 2025).

          Thus, the requested rates are reasonable.

B.        Hours Reasonably Expended

         Attorneys’ fees are awarded for the “number of hours reasonably expended on the
litigation.” Avera, 515 F.3d at 1348. Counsel should not include in their fee requests hours that are
“excessive, redundant, or otherwise unnecessary.” Saxton ex rel. Saxton v. Sec'y of Health & Hum.
Servs., 3 F.3d 1517, 1521 (Fed. Cir. 1993) (quoting Hensley v. Eckerhart, 461 U.S. 424, 434
(1983)). “Unreasonably duplicative or excessive billing” includes “an attorney billing for a single
task on multiple occasions, multiple attorneys billing for a single task, attorneys billing excessively
for intra office communications, attorneys billing excessive hours, [and] attorneys entering
erroneous billing entries.” Raymo v. Sec'y of Health & Hum. Servs., 129 Fed. Cl. 691, 703 (2016).
While attorneys may be compensated for non-attorney-level work, the rate must be comparable to
what would be paid for a paralegal or secretary. See O'Neill v. Sec'y of Health & Hum. Servs., No.
08–243V, 2015 WL 2399211, at *9 (Fed. Cl. Spec. Mstr. Apr. 28, 2015). Clerical and secretarial
tasks should not be billed at all, regardless of who performs them. See, e.g., McCulloch, 2015 WL
5634323, at *26. Hours spent traveling are ordinarily compensated at one-half of the normal hourly
attorney rate. See Scott v. Sec'y of Health & Hum. Servs., No. 08–756V, 2014 WL 2885684, at *3
(Fed. Cl. Spec. Mstr. June 5, 2014) (collecting cases). And “it is inappropriate for counsel to bill

2
  The OSM Attorneys’ Forum Hourly Rate Fee Schedules are available on the U.S. Court of Federal Claims website
at http://www.cofc.uscourts.gov/node/2914. The hourly rates contained within the schedules are updated from the
decision in McCulloch v. Sec’y of Health & Hum. Servs., No. 09-293V, 2015 WL 5634323 (Fed. Cl. Spec. Mstr. Sept.
1, 2015).

                                                       3
time for educating themselves about basic aspects of the Vaccine Program.” Matthews v. Sec'y of
Health & Hum. Servs., No 14–1111V, 2016 WL 2853910, at *2 (Fed. Cl. Spec. Mstr. Apr. 18,
2016). Ultimately, it is “well within the Special Master's discretion to reduce the hours to a number
that, in [her] experience and judgment, [is] reasonable for the work done.” Saxton, 3 F.3d at 1522.
In exercising that discretion, special masters may reduce the number of hours submitted by a
percentage of the amount charged. See Broekelschen, 102 Fed. Cl. at 728–29 (affirming the Special
Master’s reduction of attorney and paralegal hours); Guy v. Sec'y of Health & Hum. Servs., 38 Fed.
Cl. 403, 406 (1997) (same).

        Upon review of the billing records, the entries overall adequately describe the work
performed, and the time billed corresponds with that work. Thus, the requested fees requested for
the attorneys and paralegals in this case, totaling $67,796.70, are awarded in full.

C.     Reasonable Costs

        Like attorneys’ fees, a request for reimbursement of attorneys’ costs must be reasonable.
Perreira v. Sec’y of Health & Hum. Servs., 27 Fed. Cl. 29, 34 (Fed. Cl. 1992). Petitioner requests
a total of $13,641.76 in costs. ECF No. 80 at 6. This amount includes costs associated with
acquiring medical records, the filing fee, and postage. Id. These costs are routinely awarded in
vaccine cases and are supported by the receipts filed.

         Petitioner requests $1,850.00 for costs associated with having petitioner appointed
administrator of E.E.D.’s estate, on whose behalf she brought this case. See Pet. Ex. 48 at 11-12;
Pet. Ex. 47 at 14. Such costs “are generally compensable under the Vaccine Act if establishing the
estate or guardianship is ‘an essential prerequisite condition’ to obtaining an award that must ‘be
fulfilled in order for [the] award to be made.’” Bennett v. Sec'y of Health & Hum. Servs., No. 15-
65V, 2017 WL 3816094, at *3 (Fed. Cl. Spec. Mstr. Aug. 7, 2017) (quoting Haber v. Sec'y of the
Dep't of Health & Hum. Servs., No. 09-458 V, 2011 WL 839111, at *2 (Fed. Cl. Spec. Mstr. Feb.
14, 2011)). Such was the case here, where E.E.D. sadly passed away during the pendency of this
matter. Thus, the amount requested for having petitioner appointed administrator of E.E.D.’s estate
is awarded in full.

        Petitioner also requests costs associated with the expert reports filed in this matter. For Dr.
Gershwin, petitioner requests $2,500. This represents a total of five hours billed at $500 per hour.
From the record, it appears that Dr. Gershwin claimed to have spent over 12 hours working on this
case, but only billed petitioner for five hours “as a courtesy to all involved.” Pet. Ex. 48 at 16.
While certainly magnanimous, nevertheless, “[p]etitioner bears the burden of substantiating an
expert's hours.” Kantor ex rel. Kantor v. Sec'y of Dep't of Health & Hum. Servs., No. 01-679V,
2007 WL 1032378, at *2 (Fed. Cl. Spec. Mstr. Mar. 21, 2007). Petitioner must provide sufficient
documentation of the activities billed by her experts for the Court to determine whether the time
spent was reasonable. “[I]t remains counsel's responsibility to submit proof sufficient to support
the point in issue.” Saunders v. Sec'y of Dep't of Health & Hum. Servs., 26 Cl. Ct. 1221, 1226
(1992), aff'd, 25 F.3d 1031 (Fed. Cir. 1994). Here, Dr. Gershwin’s billing record consists solely of
the following line: “Review of extensive and multiple medical and surgical files with respect to
bowel obstruction and vaccination.” Pet. Ex. 48 at 16. While the Court ultimately finds Dr.
Gershwin’s time spent on this case to be reasonable under the circumstances, counsel is cautioned


                                                  4
that future billing records for experts must be sufficiently detailed for the Court to properly review
them.

          Likewise, for Dr. Santoro, petitioner requests $3,500, at $500 per hour. Here, as with Dr.
Gershwin, Dr. Santoro’s time is not adequately documented. He notes only that the $3,500 is in
exchange for “[r]etainer for case review, phone discussion and draft letter,” and does not provide
detail as to how he spent his time. Pet. Ex. 48 at 19. Nevertheless, the Court finds that the hours
spent on this case by Dr. Santoro are reasonable under the circumstances. But counsel is again
cautioned to provide sufficient documentation for time billed by experts.

        Thus, petitioner is awarded the full amount of $13,641.76 for costs requested.

                                              III.    Conclusion

        Based on the foregoing, petitioner’s Motion for Attorneys’ Fees and Costs is GRANTED.
Petitioner is hereby awarded a total of $81,438.46, representing $67,796.70 in attorneys’ fees and
$13,641.76 in costs, to be paid through an ACH deposit to petitioner’s counsel’s IOLTA
account for prompt disbursement.

        The Clerk of Court is directed to enter judgment in accordance with this decision. 3

        IT IS SO ORDERED.

                                                     s/Mindy Michaels Roth
                                                     Mindy Michaels Roth
                                                     Special Master




3
 Entry of judgment can be expedited by each party’s filing of a notice renouncing the right to seek review. Vaccine
Rule 11(a).

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