Evans v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-1458v
Filed: February 26, 2019

* * * * * * * * * * * * * * *
B.E., a minor, by and through his * PUBLISHED
parent and natural guardian, *
TARA EVANS, *
* Dismissal; Rotavirus Vaccine; Partial
Petitioner, * Intussusception; Insufficient Proof of
v. * Causation
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * *

Maximillian J. Muller, Esq., Muller Brazil, LLP, Dresher, PA, for Petitioner.
Meredith B. Healy, Esq., U.S. Department of Justice, Washington, DC, for Respondent.

DECISION DENYING ENTITLEMENT1

Oler, Special Master:

On December 2, 2015, Tara Evans (“Ms. Evans” or “Petitioner”) filed a petition pursuant
to the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et seq.2 (“Vaccine
Act” or “the Program”). In her petition Mrs. Evans alleges that the rotavirus vaccination her son
B.E. received on October 20, 2014, caused him to develop a “partial intussusception.” See Petition
(“Pet.”), ECF No. 1.

Upon review of the evidence submitted in this case, I find that Petitioner has failed to carry
her burden showing that she is entitled to compensation under the Vaccine Act. In particular,
1
This decision will be posted on the United States Court of Federal Claims’ website, in accordance with
the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to
anyone with access to the internet. As provided in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties
may object to the decision’s inclusion of certain kinds of confidential information. To do so, each party
may, within 14 days, request redaction “of any information furnished by that party: (1) that is a trade secret
or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files
or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.”
Vaccine Rule 18(b). Otherwise, this decision will be available to the public in its present form. Id.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (1986). Hereinafter,
for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C.
§ 300aa (2012).

1
Petitioner has failed to show that B.E. suffered from a partial intussusception and, further, that his
injury was caused by the vaccination he received. The petition is accordingly dismissed.

I. Procedural History

The case was initially assigned to Special Master Gowen on December 4, 2015 (ECF No.
5). Petitioner filed medical records, and then her statement of completion (ECF No. 12). This case
was reassigned to now-retired Special Master Hastings on February 22, 2016 (ECF No. 10).

Respondent filed his Rule 4(c) Report on June 3, 2016, stating that Petitioner’s case “is
not appropriate for compensation,” and that the Petition “should be dismissed for failure to
demonstrate entitlement to compensation.” Resp’t’s Report at 1-2, ECF No. 16. Respondent
argued that Petitioner had not provided enough evidence or a plausible medical theory linking the
vaccine to B.E.’s injuries. See generally Resp’t’s Report.

Petitioner submitted her expert report from Dr. John Santoro on November 18, 2016. Ex.
5, ECF No. 23. Respondent filed his expert report from Dr. Chris Liacouras on February 20, 2017.
Ex. A, ECF No. 27.

This case was reassigned to my docket on December 5, 2017. ECF No. 32. Subsequently,
I held a status conference on March 13, 2018. See Minute Entry for 3/13/2018. In that conference,
Respondent noted that there was a discrepancy between the injury alleged in the Petition and the
injury proposed by Petitioner’s expert. ECF No. 34. Petitioner’s counsel represented that B.E.’s
alleged injury was a partial intussusception. Id. I directed Petitioner to file an amended Petition
by April 12, 2018, reflecting the change in alleged injury. Id.

Petitioner filed her Amended Petition on April 12, 2018. ECF No. 37. On July 25, 2018,
and October 15, 2018, Petitioner filed additional medical records. ECF No. 38; ECF No. 39. On
October 24, 2018, Petitioner filed medical literature in support of her expert report and her
amended position alleging that B.E. suffered from a partial intussusception following his October
20, 2014 rotavirus vaccination. ECF No. 40; see also ECF No. 37.

The parties filed their pre-hearing submissions on October 26, 2018. ECF No. 41; ECF No.
42; ECF No. 43. I held an entitlement hearing in this matter on November 28, 2018. See Minute
Entry for 11/28/2018. The parties both elected not to file post-hearing briefs. This matter is now
ripe for adjudication.

II. Factual Background

A. B.E.’s Health Prior to the Allegedly Causal Vaccination

B.E. was born on August 8, 2014. Ex. 1 at 7. On September 15, 2014, Petitioner brought
B.E. to the Primary Care Clinic at Pagosa Springs Medical Center (hereinafter “Pagosa Clinic”)
with complaints of congestion and a cough. Id. Petitioner told Dr. Bricca that B.E. was more
“colicky.” Id. Petitioner stated that he cried and drank formula constantly from 5:00 pm until 9:00

2
pm. Id. Dr. Bricca recommended that Petitioner feed B.E. less in the afternoon and evening, and
that she try diluting his formula. Id. at 8.

B.E. had a well exam on October 13, 2014. Ex. 2 at 35. The notes from this visit indicate
that B.E. was weaned from breastmilk to Gentlease formula, and that he had become colicky. Id.
When B.E.’s formula was switched to Nutramigen, his colic improved. Id. The notes with respect
to elimination indicate, “[s]tringy, yellow stools, with some darker. Only Nutramigen for … about
3 weeks. Strange stools are new.” Id.

On October 20, 2014, B.E. received his rotavirus vaccination at the Pagosa Clinic. Ex. 1
at 17.

B. B.E.’s Health after the Allegedly Causal Vaccination

On October 27, 2014, Petitioner brought B.E. to the Pagosa Clinic with complaints of
persistent abdominal pain and blood in his stool for two days. Ex. 1 at 11. Petitioner told the
provider that B.E.’s stool was loose and green, containing blood and clots. Id. The notes from
this visit mention that B.E. received the rotavirus vaccine one week prior, had a temperature of
100.4 after his vaccination, but had been afebrile since. Id. The notes further state that B.E. was
fed with Nutramigen and had stomach problems since he stopped breastfeeding. Id. On this same
date, B.E. had an abdominal x-ray (Ex. 1 at 12) and an abdominal ultrasound (Ex. 1 at 13). Both
tests yielded normal results.

On October 28, 2014, Petitioner brought B.E. to the Pagosa Springs Medical Center for a
follow-up appointment. Ex. 7 at 164. Since his appointment the prior day, Petitioner reported that
B.E. had a bowel movement with some blood present. Id. The “Gastrointentinal” portion of the
“Review of Systems” section of the record notes “Diarrhea, [n]o nausea, [n]o vomiting.” Id.

B.E. visited Pediatric Partners of the Southwest on October 30, 2014. Ex. 2 at 34.
Petitioner reported a continuation of B.E.’s recent gastrointestinal symptoms. He was stooling
five to six times per day, and his stool was described as diarrhea. Id. Most recently, B.E. was
having episodes of screaming at night for 10-15 minutes. Id. The notes indicate that B.E. had
“[p]robable vaccine-strain rotavirus illness, now improving.” Id. at 35. Dr. Zemach prescribed
Neocate infant powder to replace B.E.’s formula. Id.

On November 7, 2014, B.E. presented to the Mercy Hospital Emergency Room because of
blood in his stool. Ex. 2 at 25. The history of present illness section of the record indicates that
B.E. “was well until stopping nursing at age 2-3 weeks.” Id. He changed to Gentlease formula
“after which he became ‘colicky,’ with ‘screaming all day long.’” Id. When B.E. was changed to
Nutramigen “he was ‘back to normal.’ Stools were yellow and brown, slightly stringy.” Id. The
notes indicate that after his rotavirus vaccination, B.E. developed bloody stools within three days.
Id. The record further states, “4-5 days ago: Began Neocate formula => no change, other than
decrease in stool frequency.” Id. at 26. An abdominal x-ray performed that same day yielded
normal results. Id. at 33. B.E.’s blood work, also tested on that day, returned an albumin level of
3.5 g/dL. Id. at 32. This level is below the normal range of 3.8-5.4 g/dL. Id.

3
 On November 12, 2014, B.E.’s stool study was positive for occult blood (Ex. 2 at 47) and
negative for rotavirus (Ex. 2 at 48).

On December 10, 2014, B.E. presented to the Pagosa Springs Medical Center for his four-
month well exam. Ex. 7 at 134. The exam history indicated that B.E. “had a reaction to rotavirus
in which he experienced bloody diarrhea. … Plan is to avoid further immunization with the
rotavirus.” Id. The well exam was unremarkable for any gastrointestinal problems. See Id. at
134-35.

On February 9, 2015, B.E. visited the Pagosa Clinic for his six-month well exam. Ex. 1 at
26. The well exam was unremarkable for any gastrointestinal problems. In fact, “no parental
concerns” was listed under the elimination section of the well child history. Id. B.E. was noted to
be a “[h]ealthy appearing 6 month old male, meeting developmental milestones.” Id. at 27.

On May 8, 2015, B.E. visited Dr. Zemach. Ex. 2 at 21. The chief complaint from this
encounter was that B.E. “has been constipated since rotavirus given at 2 month appointment.” Id.
The record indicates that B.E. was having hard stools that made him bleed. Id. The record further
states that B.E. went off Neocate to Nutramigen and had been drinking “straight cow’s milk for
about a month.” Id. An abdominal x-ray performed on that day was normal except for the presence
of “moderate retained stool throughout the colon.” Id. at 23. Dr. Zemach recommended Miralax
for B.E.’s constipation. Id. at 22.

On May 26, 2015, Petitioner brought B.E. back to Dr. Zemach for his nine-month well
exam. Ex. 2 at 19. B.E. was having hard stools alternating with soft ones. Id. Dr. Zermach
increased B.E.’s dosage of Miralax from one teaspoon to one tablespoon per day. Id. at 20.

On June 7, 2015, B.E. visited the Pagosa Springs Medical Center Emergency Department.
Ex. 1 at 34. Petitioner described that B.E. seemed to be in pain; he was pulling his legs up to his
chest, thrashing around in bed, and biting his blanket. Id. B.E. had a fever of 101.5 ºF and
“hypoxia down to 85% on room air.” Id. B.E. was diagnosed with pneumonia. Id. B.E. had
another abdominal x-ray during this visit, which revealed normal results except that his colon was
retaining moderate stool. Id. at 37.

On July 15, 2015, B.E. had a barium enema due to his chronic constipation. Ex. 9 at 23.
The exam revealed a “moderate amount of retained fecal material throughout the length of the
colon” but was otherwise normal. Id.

B.E. presented to Pediatric Partners of the Southwest on August 27, 2015 due to blood and
slime in his stool the night prior. Ex. 2 at 7. Petitioner reported that B.E. had a fever of 102ºF the
previous evening. Id. B.E.’s abdomen was described as “bulging moderately, firm, not hard”. Id.
at 8. The physician ordered an abdominal x-ray, which yielded normal results. Id. at 9. On August
29, 2015, B.E.’s albumin level was reported as low at 3.6 g/dL. Id. at 7.

On September 2, 2015, B.E. presented to the Section of Pediatric Gastroenterology,
Hepatology, and Nutrition at Children’s Hospital Colorado. Ex. 2 at 41. This history section notes
that B.E. had had difficulty stooling, which started after he received his rotavirus vaccination. Id.

4
He had been taking Miralax, ExLax, and mineral oil, but Petitioner stopped those medications due
to blood in B.E.’s stools. Id. Dr. Liu’s impression was that B.E. had chronic retentive constipation.
Id. at 42. He recommended restarting Miralax and ExLax. Id. On this same date, B.E. also
underwent allergy testing. Id. at 5. When exposed to the cow’s milk allergen, B.E.’s reaction
tested as “normal.” Id.

B.E. was admitted to the ER at Northwest Texas Hospital on December 14, 2015 due to
difficulty breathing and pale skin color. Ex. 4 at 2. The family was driving from California to
Oklahoma and they stopped in Amarillo, Texas due to B.E.’s condition. Id. B.E. was noted as a
picky eater, who drank between four and five 10-ounce bottles of whole milk per day. Id. at 3.
B.E.’s blood work revealed critically low hemoglobin levels (Hgb), critically low hematocrit (Hct),
along with a low red blood count (RBC), a low mean corpuscular volume (MCV), a low mean
corpuscular hemoglobin concentration (MCHC), and a high white blood count (WBC). Id. He
had tachycardia and was in mild respiratory distress. Id. at 5. Due to his abnormal blood levels,
B.E. received a blood transfusion. Id. He was discharged on December 16, 2015 and his parents
were advised to exclude dairy from B.E.’s diet. Id. at 22.

Although additional, more recent medical records were filed, they were not discussed by
the experts, and were not relevant to this analysis.

III. Expert Opinions

A. Dr. John Santoro

Petitioner filed one expert report from Dr. Santoro who also testified at the hearing. See
Expert Report, filed as Ex. 5 (ECF No. 23-1), (“Santoro Rep.”). Dr. Santoro opined that the
RotaTeq vaccination B.E. received caused him to develop a partial intussusception.

Dr. Santoro currently works at Atlantic Gastroenterology Associates, P.A., as a doctor of
osteopathic medicine and gastroenterology. See Santoro CV (ECF No. 40-2) at 1. He obtained his
Bachelor of Arts in biology from LaSalle College in 1973, and his D.O. from Philadelphia College
of Osteopathic Medicine in 1978. Id. 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 of New Jersey at the School of Osteopathic Medicine from
1979-81. Id. Dr. Santoro also completed a fellowship in gastroenterology at the University of
Medicine and Dentistry of New Jersey School of Osteopathic Medicine from 1981-83. Id. at 2.
He is board certified in internal medicine and gastroenterology. Id. Additionally, he serves as a
clinical associate professor of medicine at Rowan University School of Osteopathic Medicine. Id.
at 3. Dr. Santoro has published multiple articles in gastroenterology journals. CV at 4-5.

As a gastroenterologist, Dr. Santoro testified that he spends 88-90 percent of his time
seeing patients, with the remaining time dedicated to clinical research and teaching. Tr. at 11.
While part of his rotation involved pediatric gastroenterology, he more commonly sees patients
above the age of 11 and does not treat infants and younger children. Id. at 52. He has treated
between eight and 10 adult patients with intussusception in the past 15 years. Id.

5
 At hearing, Dr. Santoro explained intussusception to be the telescoping of the intestine
upon itself, creating a bowel obstruction. Tr. at 19. Intussusception typically occurs in the terminal
ileum into the right part of the large intestine and generally occurs in children. Id.

Dr. Santoro described a partial intussusception as “one that occurs with … a partial bowel
obstruction … that resolves spontaneously.” Tr. at 34. He further testified as follows:

Some intussusceptions, you have feet of bowel going inside the
other bowel. Sometimes you just get a little segment inside the other
bowel, and then it goes through peristalsis, and the bowel pulls apart
and it’s gone. That’s what I believe our patient may have had.
That’s what I believe the term “partial intussusception” means.

Id. at 95. Dr. Santoro did not cite to any medical literature which used the term “partial
intussusception.” He testified that the Yen article supports his theory that a partial intussusception
can occur because the article notes that intussusceptions can resolve spontaneously. See Catherine
Yen et al., Rotavirus vaccination and intussusception – Science, surveillance, and safety: A review
of evidence and recommendations for future research priorities in low and middle income
countries, HUMAN VACCINES & IMMUNOTHERAPEUTICS, Jul. 28, 2016, at 2580-89, filed as Ex. 10.9
(ECF No. 40-11) (“Yen”). Tr. at 60. Dr. Santoro further testified that the older medical literature
uses the term “chronic intussusception.” Tr. at 33.

B.E. presented to his physician on October 27, 2014, complaining of a two-day history of
abdominal pain and bloody stools. Tr. at 27. In Dr. Santoro’s opinion, B.E. suffered a partial
intussusception five days after October 20, 2014, the date B.E. received his rotavirus vaccination.
Id. Dr. Santoro based his opinion on “timing, symptoms, and rotavirus.” Id. at 87. In other words,
the fact that B.E. received a rotavirus vaccination and that he developed symptoms of abdominal
pain and bloody stools five days later led Dr. Santoro to conclude that B.E. suffered a partial
intussusception caused by his vaccination.

Dr. Santoro opined that B.E.’s intussusception had resolved by the time B.E. went to the
hospital on October 27th. Tr. at 27. As a result, B.E.’s imaging on that date did not reveal any
intestinal abnormality. Id.

Dr. Santoro also testified about B.E.’s GI symptoms in August of 2015 and whether B.E.
had experienced another partial intussusception. His testimony on this issue evolved during the
course of the proceeding. Dr. Santoro first described the August incident as follows:

I think that … one of the events a little bit down the line where he
presented with abdominal pain, elevated white count, was pretty
sick, was probably another partial intussusception, but I can’t prove
that. Unfortunately – unfortunately, there – you know, there was no
CT scan done. There was no real diagnostic study done on the
second event. So it’s just supposition on my part, purely and simply.

Tr. at 33.

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 The next discussion surrounding B.E.’s August 2015 medical visit occurred several pages
later in the proceedings.

MR. MULLER: Also, on August 27th, 2015, he presents to Pediatric
Partners of the Southwest with blood in his stool, abdominal pain
and constipation.

Do you think that any of those other symptoms, the abdominal pain,
the – the GI bleeding, could be related to the initial partial
intussusception?

DR. SANTORO: Ah, you know, it’s not clear. I personally don’t
think so, but this one event, this is the event that bothered me, and it
actually really came to my attention when I read Dr. Liacouras’
letter alluding to it.

Between August 27th and 29th – and this is on page 2 of the Doctor’s
letter – the patient presented with blood in his stool, abdominal pain,
constipation, but his belly was – his exam was this time firm,
bulging, hard3, (sic) and his lab work revealed a 19,000 white count.
That’s a little disturbing to me. Perhaps did at that time he have
another episode of an intussusception? But again, it wasn’t
diagnosed, nor was anything else.

But, I mean, like him, see a number of these children with
constipation, chronic, and they don’t have an elevated white count.
So I’m not certain about that event.

Tr. at 37.

Another series of questioning between Mr. Muller and Dr. Santoro on the topic of B.E.’s
August 2015 medical appointment and symptoms went as follows:

MR. MULLER: Prior to vaccination, on August 28th, he presents –
Petitioner presents with gastrointestinal symptoms, and then again
on September 15, he presents colicky and with increased crying. Is
it your opinion that those visits and presentation had anything to do
with the ultimate post-vaccination partial intussusception?

DR. SANTORO: The events in October you mean?

3
During the August 27, 2015 visit B.E.’s abdomen is described as “bulging moderately, firm, not hard.”
Ex. 2 at 8. The reference in this line of questioning to a hard abdomen is inconsistent with the medical
records.

7
 MR. MULLER: Yes.

DR. SANTORO: I don’t believe so.

MR. MULLER: Why not?

DR. SANTORO: I can’t relate them.

Tr. at 41-42.

Mr. Muller and Dr. Santoro continued to discuss B.E.’s August medical visit.

MR. MULLER: Dr. Santoro, I just want to go back to the August of
2015 visit. So August 27th, 2015, Petitioner presents to Pediatric
Partners of the Southwest with intermittent blood in his stool,
abdominal pain, and constipation.

DR. SANTORO: Yes.

MR. MULLER: His abdominal exam was abnormal, it was firm and
hard (sic) and bulging, and you discussed the white blood count. Do
you believe that any of that could have been related to the initial
partial intussusception as a result of the rotavirus vaccine?

DR. SANTORO: I think it’s possible. I think it’s also possible that
he had another partial intussusception, which he would be more
likely to have after the initial event.

Tr. at 47.

By the end of the hearing, Dr. Santoro opined that B.E. most likely had a second partial
intussusception in August of 2015 that had also resolved by the time Petitioner sought treatment
for her son. Tr. at 101, 103-04. Dr. Santoro testified that either B.E. had a second partial
intussusception as a result of his rotavirus vaccination, or he had a second partial intussusception
because the initial injury to the mucosal lining of his intestine left B.E. more susceptible to
developing this injury again. Id. at 47, 102.

B. Dr. Chris Liacouras

Dr. Liacouras offered a single expert report in this case and testified at the hearing. See
Expert Report, dated February 10, 2017 (filed as Resp't's Ex. A) (ECF No. 27-1) (“Liacouras
Rep.”). He is currently a professor of pediatrics and pediatric gastroenterology and nutrition at the
Perelman School of Medicine at the University of Pennsylvania, Children's Hospital of
Philadelphia. Liacouras CV, filed as Resp't's Ex. B (ECF No. 27-13); Tr. at 107. Dr. Liacouras
received his undergraduate degree from Johns Hopkins and his medical degree from Harvard
Medical School. Id. at 106. During medical school, Dr. Liacouras completed a pediatric

8
gastroenterology fellowship at Children's Hospital of Philadelphia. Id. Since then, he has
remained at Children's Hospital of Philadelphia, serving in various capacities, including director
of the Gastrointestinal Endoscopy Suite, and as a full professor of pediatrics and pediatric
gastroenterology. Id. at 107. In 2004, Dr. Liacouras was named the codirector of the Pediatric
Center for Eosinophilic Disorders. Id. at 108. This position enables Dr. Liacouras to work with
patients who have different types of food allergies, and in this capacity, he sees between 200-250
food allergy patients per year. Id. Dr. Liacouras is board certified in pediatric gastroenterology
and maintains an active medical license. Id.

Dr. Liacouras testified that he spends 80 to 85 percent of his time seeing patients, with the
rest of his time divided between conducting clinical research and teaching. Tr. at 111. Dr.
Liacouras regularly treats pediatric patients with GERD, constipation, rectal bleeding, diarrhea,
and abdominal pain, as well as children with allergic proctocolitis and food allergy. Id. at 112-13.
In addition, he has treated more than 100 infants with intussusception. Id. at 114.

Dr. Liacouras testified that in his opinion, B.E. had a milk protein allergy and not an
intussusception. Tr. at 160-62. Dr. Liacouras began the substance of his testimony by discussing
intussusception. He testified that gastroenterologists do not use the term “partial intussusception.”
Id. at 117-18. “You either make the diagnosis or you don’t. There’s no real – it may cause minimal
problems, it may cause severe problems, but it is what it is.” Id. at 118. Signs of intussusception
include abdominal pain, bleeding, a mass you can feel, and lethargy. Id. at 122.

Dr. Liacouras also stressed that in order to make the diagnosis of intussusception, you must
see evidence of the intussusception, typically with either a barium enema or an abdominal
ultrasound. Id. at 120. When an ultrasound is performed and interpreted by a qualified and
knowledgeable physician, it is nearly 100 percent definitive. Id. at 122. According to Dr.
Liacouras, the telescoped bowel on ultrasound actually appears as a target sign. Id. Because B.E.
never had imaging that showed an intussusception, Dr. Liacouras testified that B.E. did not have
an intussusception.

Dr. Liacouras testified persuasively that B.E.’s symptoms were attributable to a milk
protein allergy, or allergic proctocolitis.4 Symptoms of allergic proctocolitis in children include
mucousy, stringy stools, and bleeding. Tr. at 130. The typical treatment for allergic proctocolitis
is to remove the offending antigen. Id. In the case of B.E., Dr. Liacouras pointed to the fact that
B.E.’s pediatricians switched his formula several different times, which is the appropriate response
to address a potential food allergy. Id. at 174. After being breastfed for two to three weeks, B.E.
was weaned to Gentlease formula. He was then switched to Nutramigen due to colic. B.E.
continued to experience symptoms of stringy stools while on Nutramigen, so he was again
switched to Neocate. Ex. 2 at 25-26.

Dr. Liacouras testified as to the differences between these formulas. He testified that

4
Allergic proctocolitis or eosinophilic proctocolitis is a “manifestation of a food allergy, consisting of
inflammation of the mucosa of the rectum and colon with eosinophilic infiltration, usually in infants during
the first two months of life.” It is most often caused by a reaction to cow’s milk or soy milk formulas.
Most infants present with rectal bleeding or blood in the feces. Dorland’s Illustrated Medical Dictionary
(32nd ed. 2012) at 1521 (hereinafter “Dorland’s”).

9
Gentlease is a milk-based formula. Tr. at 134. Dr. Liacouras described the other two formulas as
follows:

Let’s say a milk protein or a soy protein is a certain size, … and that
protein causes immunologically a problem with the way your
intestine senses it, sees it, and it causes irritation because of the way
it – it kind of interacts with that protein.

Nutramigen is a protein that may reduce the size of that by 60 to 70
percent. So now it’s more easily digestible, okay? It’s not this big,
whopping protein that could be causing trouble, but it’s not perfect.
There’s still 20 to 30 percent of that protein that’s still there, and it
can cause a reaction like the other proteins were doing.

Then you get down to this other formula called Neocate, and that’s
basically amino acids, if you can remember way back to biology.
You’re talking about the basic building blocks of protein, so you
can’t have an allergy to those basic building blocks, and that’s why
that formula, if you need to, works better.

Id. at 139-40.

While B.E. was on Neocate, he did not have any gastrointestinal-related visits to the doctor.
According to Dr. Liacouras, this was also suggestive that B.E. had a milk protein allergy. Tr. at
146-47. In fact, B.E. next presented to his doctor with GI complaints on May 8, 2015,
approximately six months after his most recent GI-related visit in November. Id. at 149. The
record from that visit in May indicates that B.E. transitioned from Neocate to Nutramigen and then
to cow’s milk. Ex. 2 at 21. As Dr. Liacouras described it, “sometime between November and
May, the mother changed the formula back to cow’s milk, with or without the physician’s
direction.” Tr. at 149. He testified that in his opinion, B.E. began experiencing an allergy to cow’s
milk, which can be manifested by either diarrhea or constipation. Id. at 149-50.

Dr. Liacouras testified that there are different types of allergies to food. An anaphylactic
allergy, for example, a peanut allergy, causes the immune system to produce IgE antibodies to an
allergen that can cause a susceptible individual to go into shock.5 The other main type of food
allergy is non-IgE T-cell allergy. Tr. at 141. This type of food allergy is caused by an immune
reaction not involving IgE antibodies. Id. at 140-41. Because an allergy to milk protein is a non-
IgE T-cell allergy, there is no diagnostic allergy test that can be performed to detect the food
allergy. Id. at 140. Dr. Liacouras explained that this is why B.E.’s allergy tests came back as
normal. Id. at 173-74. Treating physicians generally see that the patient has symptoms, and then
eliminate the offending allergen. Id. at 140.

5
See Jonathan E. Markowitz & Chris A. Liacouras, Allergic and Eosinophilic Gastrointestinal Disease, in
PEDIATRIC GASTROINTESTINAL AND LIVER DISEASE 429, 429 (Wyllie, Hyams, Kay eds., 2016), filed as
Ex. A-11.

10
 Dr. Liacouras further supported his opinion that B.E. had a milk protein allergy by pointing
to B.E.’s low albumin levels.6 On November 7, 2014, B.E. presented to the Mercy Hospital
Emergency Room because of blood in his stool. Ex. 2 at 25. B.E.’s blood work returned an
albumin level of 3.5 g/dL, which was low. Id. at 32. B.E. had changed formula from Nutramigen
to Neocate four to five days previously.7 Further, on August 29, 2015, B.E. saw his physician due
to blood and slime in his stool. At this point, B.E. had transitioned to cow’s milk. His albumin
level was again reported as low at 3.6 g/dL. Id. at 7. According to Dr. Liacouras, albumin levels
can be low when you have intestinal irritation or colitis. Tr. at 138.

Dr. Liacouras also discussed B.E.’s ER admission on December 14, 2015, and how he
believes B.E.’s milk protein allergy was a partial cause of B.E.’s medical problems. Dr. Liacouras
testified that B.E. most likely had chronic inflammation and low-grade bleeding as a result of his
milk protein allergy. Tr. at 158. In addition to this blood loss, B.E. was drinking 40-50 ounces of
whole milk per day and was not eating much of any other food. This milk intake, combined with
his milk protein allergy, caused a severe iron deficiency. Id. at 157-58, 177. B.E.’s hemoglobin
measured at 2.7, while a healthy child of his age should have a hemoglobin of 12-13. Id. at 156.
This means that B.E. did not have enough red blood cells to transport oxygen throughout his body,
which led to respiratory distress. Id. at 157.

Ultimately, Dr. Liacouras testified that there is no evidence anywhere in the medical
records that B.E. had an intussusception, while there is definitive evidence of a milk protein
allergy. Tr. at 160.

IV. Applicable Law

A. Petitioner’s Overall Burden in Vaccine Program Cases

Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner may
demonstrate that he suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table
that occurred within the time period provided in the Table. § 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 in the Vaccine Injury
Table, a petitioner may demonstrate that he suffered an “off-Table” injury. § 11(c)(1)(C)(ii).

For both Table and non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. § 13(1)(a). That is, a petitioner must offer evidence that leads
the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before
[she] 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, 1324 (Fed. Cir. 2010);

6
Albumin is “any protein that is soluble in water and moderately concentrated salt solutions, and is
coagulable by heat. … Decreased serum albumin (hypoalbuminemia) occurs in protein malnutrition, active
inflammation, and serious hepatic and renal disease.” Dorland’s at 44.
7
According to Dr. Liacouras, allergic proctocolitis can take anywhere from 10 days to six weeks to
completely resolve. Tr. at 145.

11
see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or
speculation is insufficient under a preponderance standard). Proof of medical certainty is not
required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In
particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the
injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321
(quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999));
Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner
may not receive a Vaccine Program award based solely on his assertions; rather, the petition must
be supported by either medical records or by the opinion of a competent physician. Section
13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a
non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen
requires that petitioner establish by preponderant evidence that the vaccination he received caused
his injury “by providing: (1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was the reason for the
injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.”
Id. at 1278.

Each of the Althen prongs requires a different showing. Under Althen prong one,
petitioners must provide a “reputable medical theory,” demonstrating that the vaccine received can
cause the type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this
prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific
explanation.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994).
Such a theory must be only “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009)
(citing Capizzano, 440 F.3d at 1325-26). Special Masters, despite their expertise, are not
empowered by statute to conclusively resolve what are complex scientific and medical questions,
and thus scientific evidence offered to establish Althen prong one is viewed “not through the lens
of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y
of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility … in many cases may be
enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d
1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish
his overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Human
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).

The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion
testimony are favored in vaccine cases, as treating physicians are likely to be in the best position

12
to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the
reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed
as particularly trustworthy evidence, since they are created contemporaneously with the treatment
of the patient. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing … that mandates that the testimony of a treating physician is sacrosanct -- that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record -- including conflicting
opinions among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742,
749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’
conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health &
Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed.
Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to
the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer
“preponderant proof that the onset of symptoms occurred within a timeframe which, given the
medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de
Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation
for what is a medically acceptable timeframe must also coincide with the theory of how the relevant
vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of
Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl.
353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human
Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review
den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).
The special master is required to consider “all [] relevant medical and scientific evidence contained
in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s
report which is contained in the record regarding the nature, causation, and aggravation of the
petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic
or evaluative test which are contained in the record and the summaries and conclusions.” Section
13(b)(1)(A). The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Human Servs.,

13
3 F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether
to afford greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).

Medical records created contemporaneously with the events they describe are presumed to
be accurate and “complete” such that they present all relevant information on a patient’s health
problems. Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed. Cl.
598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health &
Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption
is based on the linked proposition that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013), mot. for review den’d (Fed. Cl. Feb. 11, 2019); Cucuras v. Sec’y of Health &
Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains
reason to conclude that petitioners would fail to accurately report the onset of their daughter’s
symptoms.”).

Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony --
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United
States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon
common sense and experience, this rule should not be treated as an absolute and must yield where
the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19
(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent and

14
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Human
Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In
determining the accuracy and completeness of medical records, the Court of Federal Claims has
listed four possible explanations for inconsistencies between contemporaneously created medical
records and later testimony: (1) a person’s failure to recount to the medical professional everything
that happened during the relevant time period; (2) the medical professional’s failure to document
everything reported to her or him; (3) a person’s faulty recollection of the events when presenting
testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v.
Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir.
2014). In making a determination regarding whether to afford greater weight to contemporaneous
medical records or other evidence, such as testimony at hearing, there must be evidence that this
decision was the result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of
Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony
is usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert
v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health &
Human Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human
Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability
of testimony are: (1) whether a theory or technique can be (and has been) tested; (2) whether the
theory or technique has been subjected to peer review and publication; (3) whether there is a known
or potential rate of error and whether there are standards for controlling the error; and (4) whether
the theory or technique enjoys general acceptance within a relevant scientific community.”
Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora. Daubert factors are employed by judges to exclude
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 743. In this matter, (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

15
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a
particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y
of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this 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”).

D. Consideration of Medical Literature

Finally, although this decision discusses some but not all of the medical literature in detail,
I reviewed and considered all of the medical records and literature submitted in this matter. See
Moriarty v. Sec’y of Health & 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).

V. Analysis

Because Petitioner does not allege an injury listed on the Vaccine Injury Table, Petitioner’s
claim is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, Petitioner
must prove by preponderant evidence that B.E. suffered an injury and that this injury was caused
by the vaccination at issue. See Capizzano, 440 F.3d at 1320.

A. Overview of Intussusception

Intussusception is defined as the invagination, or telescoping, of one segment of the
gastrointestinal tract into another resulting in intestinal obstruction. Anthony C. Manning &
Danny C. Little, Intussusception in Infants and Children, in PEDIATRIC GASTROINTESTINAL AND
LIVER DISEASE 607 (Robert Wyllie et al. 5th ed. 2015), filed as Ex. A-1 (ECF No. 27-2)
(“Manning”). Intussusception is most common among infants and toddlers in the first two years
of life. Manning at 607. Two-thirds of intussusception patients are male. Id. The initial signs of
intussusception include acute and severe stomach pain and vomiting. Liacouras Rep. at 3. “The
classic features, known as the ‘classic triad,’ include severe abdominal pain, vomiting and currant
jelly stools.” Id.

The cause of intussusception is unknown.8 Research suggests that an intussusception can be
triggered by post-infection hyperplasia in the intestinal tract following rotavirus, and generally

8
Christine G. Robinson et al., Evaluation of Anatomic Changes in Young Children with Natural Rotavirus
Infection: Is Intussusception Biologically Plausible?, 189 J INFECT DIS. at 1382 (2004), filed as Ex. 10.8.

16
occurs within 21 days after the initial rotavirus vaccination. Yih et al., Intussusception Risk after
Rotavirus Vaccination in U.S. Infants, 370 New Eng. J. Med. 503, 506 (2014), filed as Ex. 10.6
(ECF No. 40-8) (“Yih”).

An intussusception is a life-threatening illness. Yen at 2581. Untreated, intussusception can
cause internal bleeding. Tr. at 122. Typically, an intussusception diagnosis can be made using an
abdominal x-ray, abdominal ultrasound, or a barium enema. Id. at 187-88. Treatment options can
include an air enema or a surgical intervention. Yen at 2581.

B. Petitioner has not Carried her Burden of Proof

1. I Weighed the Testimony of Dr. Liacouras over that of Dr. Santoro

a. Qualifications

Dr. Liacouras is board certified in pediatric gastroenterology and he regularly diagnoses
and treats children with GERD, constipation, rectal bleeding, diarrhea, and abdominal pain, as well
as children with allergic proctocolitis and food allergy. Tr. at 112-13. In addition, he has treated
more than 100 infants with intussusception. Id. at 114. Dr. Liacouras’ clinical practice and
academic career are focused on children with GI issues.

While Dr. Santoro is qualified to testify as an expert, his background is not as strong as
that of Dr. Liacouras. For the past 15 years, Dr. Santoro has not treated any children under the age
of 11. Tr. at 52. Further, he has treated 8-10 adult patients with intussusception in the past 15
years. Id.

b. Familiarity with the Medical Records

Dr. Santoro did not display the same level of familiarity with the medical records as did
Dr. Liacouras. For example, Dr. Santoro testified that one of the reasons he did not believe B.E.
suffered from allergic proctocolitis was because B.E. did not experience diarrhea. See Tr. at 70.
(“Diarrhea, not constipation. That's one of the main reasons … I disagree with the Doctor that the
patient had [allergic proctocolitis], because in his own article, he states that most kids have
significant diarrhea with proctocolitis. He had none.”) In fact, B.E.’s medical records make it clear
that B.E. did suffer from diarrhea. On October 28, 2014, B.E.’s medical records note “Diarrhea,
[n]o nausea, [n]o vomiting.” Ex. 7 at 164. Further, the records from October 30, 2014 indicate
that B.E. was stooling five to six times per day, and his stool was described as diarrhea. Ex. 2 at
34.

As a second example, Dr. Santoro seemed to be unaware that Petitioner had brought B.E.
in for GI-related issues prior to his receipt of the rotavirus vaccine.

MS. HEALY: Now, on page 1 of your report, which for the record
is Petitioner's Exhibit 5, you state, "At the time of vaccination,
Petitioner was a healthy child with no significant history of
gastrointestinal disorders."

17
 DR. SANTORO: What page are you on?

MS. HEALY: Page 1.

DR. SANTORO: Yeah, I see that. Yep.

MS. HEALY: But you are aware that during the month leading up
to the child's October 20th, 2014, rotavirus vaccination, he on more
than one occasion presented to a healthcare provider and concerns
were raised about his gastrointestinal system.

DR. SANTORO: Yeah. Actually, I was just made aware of that
recently. I didn't -- I didn't appreciate that before.

Tr. at 63.

c. Dr. Santoro’s Testimony was Internally Inconsistent

On more than one occasion,9 Dr. Santoro expressed an opinion during this course of his
testimony, and then changed that opinion soon thereafter. For example, he testified regarding the
issue of B.E.’s constipation and whether that constipation was related to the initial partial
intussusception.

DR. SANTORO: I guess the logical next question is -- and I don't
want to put words in your mouth -- did his constipation come from
the intussusception? Were you thinking of asking that question?

MR. MULLER: I was planning on it, sure.

DR. SANTORO: Okay, all right. I don't think so, actually.

We never discussed this, but, you know, Dr. Talley, when I was in
pediatric GI, every other patient was a chronic constipation, usually
of the stool withholding variety, and it's a common thing. And my
grandchild, who's eight years old and lives with me, has it. You
know, it's a very common thing. He never had intussusception. He
did have rotavirus vaccine. But I think it's a complex cause probably
not related to the vaccine.

Tr. at 36. Soon after expressing this opinion, Dr. Santoro testified that B.E.’s constipation and
other GI symptoms were related to the initial event.

9
For another example of internal inconsistency, see my discussion of B.E.’s August 2015 medical
appointment, discussed supra.

18
 MR. MULLER: So page 2 -- Exhibit 4, page 2, the past medical
history. He had a rotavirus infection after his two-month rotavirus
vaccine [sic]. He developed constipation after that. He was seeing
the GI doctor at Denver, received 90 doses of mineral oil, Miralax,
barium enema. What I'm asking is, these continued visits post the
initial reaction for constipation, for abdominal pain, for rectal
bleeding, do you think that that is just happenstance or do you think
that that is related to the initial -- do you think his ongoing problems
relate to his initial --

DR. SANTORO: My inclination would say that it is related to the
initial visit -- I mean, the initial event. Number one, children, after
having a serious event like that, can often be sensitized and react
with stool withholding, react with constipation.

Tr. at 49-50.

Due to his relative lack of clinical experience with young children when compared with
Dr. Liacouras, his level of familiarity with the medical records, and the internal inconsistencies
in his testimony, I gave less weight to the opinion of Dr. Santoro than I did to Dr. Liacouras.

2. There is not Preponderant Evidence that B.E. Suffered from a Partial Intussusception

The first step in an “off-Table” claim is to “determine what injury, if any, was supported
by the evidence presented in the record.” Lombardi v. Sec’y of Health & Human Servs., 656 F.3d
1343, 1353 (Fed. Cir. 2011). The Vaccine Act “places the burden on the petitioner to make a
showing of at least one defined and recognized injury,” and “[i]n the absence of a showing of the
very existence of any specific injury[,] . . . the question of causation is not reached.” Id.; see
Broekelschen, 618 F.3d at 1346 (explaining that “identifying the injury is a prerequisite to the
[causation] analysis”). In this case, Petitioner has not demonstrated that B.E. suffered from an
intussusception, partial or otherwise.

a. “Partial Intussusception” is not a Recognized Term in the Medical Community

First, although Dr. Santoro uses the term “partial intussusception,” that term is not
mentioned in any of the medical literature, a point that Dr. Santoro acknowledges during his
testimony. See Tr. at 71. Dr. Liacouras testified that he has never heard the term, and that a patient
either has an intussusception or does not have one. Tr. at 117-18. Dr. Santoro cites to the Yen
article for support of his position that a partial intussusception can occur. That article mentions
that intussusceptions can spontaneously resolve. See Yen at 2581. However, Dr. Liacouras
emphasized in his testimony that any intussusception, to include one that spontaneously resolves,
must be seen on imaging in order to make an intussusception diagnosis. Tr. at 124-25. This final
and critical point was unrebutted by Dr. Santoro.

b. None of B.E.’s Imaging Indicated that he Had an Intussusception

19
 Abdominal pain and bloody stools are both symptoms that can be caused by many different
conditions, including: constipation, food allergy, inflammatory bowel disease, infection, viral
disease, bacterial disease, polyps, and congenital abnormalities of the GI tract. Tr. at 120, 125-26.
Abdominal pain and gastrointestinal bleeding are relatively common in infants. Tr. at 113, 125.
These symptoms may cause doctors to order imaging to assess for intussusception (as was likely
done in this case), but the fact that B.E. had abdominal pain and bloody stools is not, by itself,
diagnostic of intussusception.

The only way to definitively diagnose intussusception is through imaging. Tr. at 120.
Barium enema and abdominal ultrasound are the most commonly used tests. Id. at 187-88. In
fact, an abdominal ultrasound is nearly 100 percent accurate if interpreted properly. Id. at 122.
See also, H.M.L. Carty, Paediatric emergencies: non-traumatic abdominal emergencies,
EMERGENCY RADIOLOGY, Jul. 27, 2002, 2835, 2839, filed as Ex. A-2 (ECF No. 27-3) (stating
“[u]ltrasound has a 100% diagnostic accuracy in expert hands.”). Abdominal x-rays are also useful
when the condition is severe because they will show evidence of bowel obstruction, altered gas
pattern, or other unusual changes to the intestine. Id. at 188. B.E. had a total of seven diagnostic
imaging tests performed between October 2014 and August 2015. See Ex. 1 at 12-13 (an
abdominal x-ray and an abdominal ultrasound on October 27, 2014); Ex. 2 at 33 (an abdominal x-
ray on November 7, 2014); Ex. 2 at 23 (an abdominal x-ray on May 8, 2015); Ex. 1 at 37 (an
abdominal x-ray on June 7, 2015); Ex. 9 at 23 (a barium enema on July 15, 2015); Ex. 2 at 9 (an
abdominal x-ray on August 27, 2015). None of these tests showed any evidence of intussusception.

c. B.E.’s Abdominal Pain Began Before his Rotavirus Vaccination

Dr. Santoro testified that on two occasions, (October 2014 and August 2015), B.E. suffered
from a partial intussusception, and by the time he saw a doctor, each intussusception had resolved.
In support of this theory, Dr. Santoro points to B.E.’s symptoms, which included abdominal pain
and bloody stools. Because these two symptoms occurred five days after B.E. received his
rotavirus vaccination, Dr. Santoro believes that B.E. suffered an intussusception caused by his
vaccination.10

However, the medical records make clear that B.E. suffered from abdominal pain before
he received his rotavirus vaccination. Medical visits on September 15, 2014 and October 13, 2014
both indicate that when he transitioned from breastmilk to Gentlease formula, B.E. became
“colicky.” Ex. 1 at 7; Ex. 2 at 35. Even the medical records from the post-vaccination visit on
October 27, 2014 indicate that B.E. has had stomach problems since he stopped breastfeeding. See
Ex. 1 at 11. The records from November 7, 2014 state that B.E. “was well until stopping nursing
at age 2-3 weeks.” Id. He changed to Gentlease formula “after which he became ‘colicky,’ with
‘screaming all day long.’” Id. These records clearly demonstrate that B.E.’s abdominal pain, one

10
Dr. Santoro’s theory of causation is unclear with respect to the second episode of partial intussusception
in August of 2015. While he bases his opinion regarding the first partial intussusception in October 2014
on “timing, symptoms, and rotavirus” (Tr. at 87), the second partial intussusception in August 2015 would
have been 10 months after vaccination. While he opines that it was, “more probable than not” that B.E.
experienced an intussusception (Tr. at 103), Dr. Santoro’s reasons for this statement were not fully
developed.

20
of the two symptoms upon which Dr. Santoro relied in arriving at his opinion, actually predated
B.E.’s rotavirus vaccination.

d. B.E. Continued to Experience Symptoms after his Initial “Partial
Intussusception” Resolved

Petitioner’s theory that B.E. experienced two separate partial intussusceptions that both
resolved before B.E. went into the hospital is not supported by the medical records. Dr. Santoro
testified that B.E. experienced his first partial intussusception on October 25, 2014, and that the
intussusception spontaneously resolved. However, the medical records demonstrate that B.E.
continued to experience abdominal symptoms until at least November 12, 2014 when his stool
study tested positive for occult blood. See Ex. 2 at 25; Ex. 2 at 48. Dr. Santoro does not explain
why B.E.’s symptoms persisted for this long if the intussusception had resolved.

Dr. Santoro testified that a partial intussusception would resolve, “[c]ertainly within a
week, but usually in a few days, two to three days, four days.” Tr. at 35. A convoluted colloquy
on the timeframe for the resolution of B.E.’s intussusception took place later in the proceeding.
See Tr. at 77-81. This discussion concluded as follows:

THE COURT: What do you think is causing the blood in his stool –
on the 7th of November?

THE WITNESS: On the 7th? One supposition – I don’t know,
because they don’t make a diagnosis here, so I have to guess or I
have to make an educated guess. They don’t say bleeding from
fissure. They don’t describe a fissure in this report.

Could he have had a fissure? Maybe. Could he have had an
intussusception a few days earlier and it’s – or an ulcer related to the
initial intussusception and that’s bleeding? Yes. I wish they would
have made a firm diagnosis.

THE COURT: So you don’t really know what’s causing the blood
one way or another?

THE WITNESS: On this November 7th period of time –

THE COURT: Correct.

THE WITNESS: -- yeah, we don’t.

Tr. at 80-81.

Dr. Liacouras also addressed this matter: “if you had an intussusception that causes you
enough damage that could give you poor resolution and bleeding for weeks, you are going to see
something on ultrasound, either thickening of the bowel wall, some – there has got to be some

21
evidence of ongoing disease giving you that problem.” Tr. at 123. B.E.’s continuation of
symptoms into November is not indicative of intussusception given the fact that there was
absolutely no evidence of intussusception on any of B.E.’s imaging.

e. The Mention of Rotavirus in B.E.’s Medical Records Does Not Establish B.E.
Suffered an Intussusception

B.E.’s physicians mention his rotavirus vaccination several times in the medical records.
On October 30, 2014, B.E. visited Pediatric Partners of the Southwest for his GI complaints. The
records from this visit state, “[p]robable vaccine-strain rotavirus illness, now improving.” Ex. 2
at 35. This note was entered into B.E.’s medical records before his blood tested negative for
rotavirus on November 12, 2014. See Ex. 2 at 48. There is no evidence in the record that B.E.
suffered from vaccine-strain rotavirus.

The medical records from December 10, 2014 state that B.E. “had a reaction to rotavirus
in which he experienced bloody diarrhea. … Plan is to avoid further immunization with the
rotavirus.” Ex. 7 at 134. The basis for this entry in unclear.

I have considered the fact that two of B.E.’s treating physicians either considered B.E. had
a “probable vaccine-strain rotavirus,” or attributed B.E.’s bloody diarrhea to his vaccination. It is
well established that the views of treating physicians are important; however they are also properly
subject to evidentiary weighing. Capizzano, 440 F.3d at 1326. See Snyder, 88 Fed. Cl. at 746.
When evaluated in light of the entire record, to include all of B.E.’s negative diagnostic imaging,
Dr. Liacouras’ credible testimony, the lack of medical literature mentioning the term “partial
intussusception,” and the strong evidence in support of milk protein allergy, I am not persuaded
by these two entries.

The Petitioner has established B.E. experienced abdominal pain and bloody stools. These
symptoms, without more, do not constitute preponderant evidence that B.E. suffered from an
intussusception. Accordingly, Petitioner has failed to meet her burden.

3. Analysis of the Althen Prongs

Because Petitioner has not established that B.E. had an intussusception, further analysis is
unnecessary. However, for the sake of completeness, I will briefly analyze the Althen prongs.

a. Althen Prong 1: The Rotavirus Vaccine Can Cause Intussusception

It is well established that the rotavirus vaccine can cause intussusception. See e.g., Yih at
503-06. In fact, intussusception that occurs between one and 21 days after rotavirus vaccination
is a Table injury. See 42 C.F.R. § 100.3 (2017). Had Petitioner established that B.E. experienced
an intussusception, Althen prong one would have been met in this case with respect to B.E.’s
October 25, 2014 GI incident.

However, Petitioner has not established that the rotavirus vaccine could cause more than
one intussusception. Specifically, Petitioner did not offer any evidence to establish that the

22
rotavirus vaccine could cause an infant to experience recurring partial intussusceptions. Therefore,
Petitioner has failed to meet Althen Prong 1 with respect to the August 2015 event.

b. Althen Prong 2: There is not Preponderant Evidence that the Rotavirus Vaccine
Did Cause Intussusception in B.E.’s Case

As discussed above, there is not sufficient evidence in this record to demonstrate that B.E.
suffered one or more intussusceptions. B.E.’s symptoms of abdominal pain and bloody stools are
relatively non-descript. In fact, B.E. began to experience abdominal pain before his rotavirus
vaccination. Further, the absence of any abnormality on any of B.E.’s diagnostic testing
demonstrates that he did not have an intussusception, either in October 2014 or in August of 2015.

There is not preponderant evidence that B.E. suffered an intussusception and therefore, that
the rotavirus vaccine caused any of B.E.’s injuries.

c. Althen Prong 3: Five Days Post-Vaccination Is a Medically-Appropriate Onset
Interval, but 10 Months Is Not

The medical literature offered in this case establishes that there is a short temporal
association between rotavirus vaccination and intussusception. See Yih at 506. This is consistent
with the one to 21 day timeframe provided for in the Vaccine Injury Table (see 42 C.F.R. § 100.3
(2017)). Dr. Liacouras also testified that the medically-appropriate temporal gap between
rotavirus vaccination and intussusception is onset within 21 days. Tr. at 189. In this case, had
B.E. experienced an intussusception five days after his rotavirus vaccination, this would have
amounted to a medically-appropriate onset interval.

However, the same is not true of B.E.’s purported second partial intussusception in August
2015. This incident occurred more than 10 months after B.E. received the rotavirus vaccination.
As noted, supra, Dr. Santoro provided inconsistent testimony as to whether he believed this event
was an intussusception caused by B.E.’s vaccination. In terms of the timing of the second partial
intussusception, Dr. Santoro testified as follows:

Well, assuming that he had some injury to the mucosal lining of the
intestine, he could be at risk for further intussusception occurring
down the line, at least until the bowel matured, you know, until a
couple of years of age, but, you know, there are outliers to the -- to
the time frame recommendation, but they’re less common.

In one of the reports I reviewed last year, there were cases occurring,
you know, 79, 80 days after the rotavirus vaccine, I wish I could be
clearer on that, but the records…

Tr. at 102. Petitioner did not file medical literature supporting the proposition that rotavirus
vaccine causes intussusception 10 months later. She did not file literature stating an injury to the
mucosal lining of the intestine from one intussusception makes patients more likely to suffer a
second intussusception nearly one year later. Accordingly, I find there is not preponderant

23
evidence that an intussusception 10 months post-rotavirus vaccination constitutes a medically-
appropriate onset interval.11

4. Alternate Causation -- It is More Likely than not that B.E. Suffered from a Milk Protein
Allergy

Had Petitioner provided sufficient preponderant evidence that B.E.’s rotavirus vaccination
caused him to suffer an intussusception, the burden would then shift to Respondent to establish
(also by the same preponderance of the evidence standard) that B.E.'s injuries are due to “factors
unrelated” to the vaccine. C.K. v. Sec'y of Health & Human Servs., 113 Fed. Cl. 757, 766 (2013)
(citing Knudsen, 35 F.3d at 547); Deribeaux v. Sec'y of Health & Human Servs., 105 Fed. Cl. 583,
587 (2012), aff'd, 717 F.3d 1363 (Fed. Cir. 2013); see also Knudsen, 35 F.3d at 547; 42 U.S.C. §
300aa–13(a)(1)(B). Respondent can meet his burden by relying on evidence derived from the same
record that a Petitioner draws upon to carry his initial burden. While I have determined that
Petitioner has not met her burden that B.E.’s injury was caused by his vaccination, I will analyze
the issue of alternate causation.

Dr. Liacouras’ testimony and his citation to the medical records established by a
preponderance of the evidence that B.E. suffered from a milk protein allergy.

a. B.E.’s Symptoms Are Associated with his Change in Formula or the Addition
of Milk to his Diet

The medical records make clear that B.E. first developed abdominal pain after he was
weaned from breastmilk. On September 15, 2014, Petitioner brought B.E. to the pediatrician. She
mentioned that B.E. was colicky12, and that he cried and drank formula constantly from 5:00 pm
to 9:00 pm. Ex. 1 at 11. The pediatrician recommended diluting B.E.’s formula. Id. at 8.
According to Dr. Liacouras, this signified that the doctor “thought the formula may have some
relationship to the symptoms.” Tr. at 132-33. Additionally, during his well-child exam on October
12, 2014, the records indicate that when B.E. transitioned from breastmilk to Gentlease formula,
he became “colicky” (Ex. 2 at 35) and had been “screaming all day long.” Id. at 25. This is another
early indication that B.E. had a milk protein allergy. Tr. at 144.

After recommending dilution of the Gentlease formula, the pediatrician next changed

11
Based on this finding, it does not appear Petitioner has established that B.E. met the severity requirement
in this case. Under the Vaccine Act’s severity requirement , a vaccinee must have: “suffered the residual
effects or complications of such illness, disability, injury, or condition for more than 6 months after the
administration of the vaccine, or died from the administration of the vaccine, or suffered such illness,
disability, injury, or condition from the vaccine which resulted in inpatient hospitalization and surgical
intervention[.]” § 11(c)(1)(D). B.E. received his rotavirus vaccination on October 20, 2014, suffered a
purported partial intussusception on October 25, 2014, and according to Dr. Santoro, experienced residual
effects that resolved within one week. Tr. at 35. In order to meet the Act’s severity requirement, B.E.
would have needed to experience sequelae from his partial intussusception through April 20, 2015.
12
According to Dr. Liacouras, “colicky” refers to abdominal pain in 99% of infants. Tr. at 171.

24
B.E.’s formula from Gentlease to Nutramigen. Ex. 2 at 35. Gentlease is a milk-based formula,
while Nutramigen “is one of those hydrolyzed formulas that, in theory, is a better nonallergenic
formula.” Tr. at 133. We can infer that by changing formula from Gentlease to Nutramigen,
B.E.’s pediatrician suspected the Gentlease formula to be the cause of B.E.’s symptoms. See Id.

Once B.E. transitioned to Nutramigen, his colic improved. Ex. 2 at 35. However, it was
noted during his October 13, 2014 well exam that he had developed “stringy, yellow stools, with
some darker.” Id. At the time of this visit, B.E. had been on Nutramigen for about three weeks.
Id. According to Dr. Liacouras, stringy yellow stools can often mean that the stool contains
mucous strands; darker stools can mean that there is some hidden occult blood in the stool. Tr. at
133-34, 172. In his view, the progression of B.E.’s symptoms was consistent with a milk protein
allergy: “When you have a milk protein allergy, it often starts out slow and gets worse, and until
you do something to correct it … the symptoms continue and get worse.” Id. at 134-35.

B.E.’s symptoms did, in fact, get worse. On October 27 and 28, 2014, Petitioner brought
B.E. to see a doctor due to abdominal pain and blood in his stool. Ex. 1 at 11. B.E. was noted to
have diarrhea. Ex. 7 at 164. His stool was described as loose and green, and it contained blood.
Ex. 1 at 11. Diarrhea is a symptom that is consistent with a food allergy. Tr. at 135.

On November 7, 2014, B.E. presented to the ER because he continued to have blood in his
stool. Ex. 2 at 25. Significantly, this record indicates that B.E. had begun Neocate formula in the
past four to five days. Id. at 26. At this point, B.E.’s stooling had decreased, but his stool still
contained blood. Id. Dr. Liacouras was not surprised by B.E.’s continued symptoms while on
Neocate because it can take up to a month for the intestine to fully heal from a milk protein allergy.
Tr. at 138-39. Dr. Liacouras testified that Neocate is the amino acid-based formula that is virtually
non-allergenic. Id. at 137. Neocate is also extremely expensive and can be obtained only through
a prescription from a physician. Id. at 175. According to Dr. Liacouras, it is so expensive that
“[y]ou’re not going to do that unless you think milk protein or some kind of food allergy is causing
a problem.” Id.

After beginning Neocate in early November 2014, B.E. did not return to the doctor with
any GI complaints until May 2015.13 This fact is significant in that once B.E. was not exposed to
any milk protein allergens, he stopped having GI symptoms.

On May 8, 2015, B.E. presented with constipation, which Petitioner told the physician had
been present since B.E. had received the rotavirus vaccination.14 Ex. 2 at 21. The medical records
from this visit state that B.E. went off Neocate onto Nutramigen and had been drinking cow’s milk
for about one month. Id. B.E. continued to experience constipation through June of 2015. See

13
During this six-month interval, B.E. presented for appointments on December 10, 2014, and on February
9, 2015. Both exams were unremarkable for any type of GI complaint. See Ex. 7 at 134-35; Ex. 1 at 26-
27; Tr. at 146-47.
14
The medical records do not support this contention. B.E. experienced diarrhea after transitioning from
Gentlease to Nutramigen, see Ex. 1 at 11; Ex. 7 at 164; Ex. 2 at 34. The records from May 8, 2015 are the
first set of medical records which mention constipation.

25
Ex. 2 at 19; Ex. 1 at 37. Dr. Liacouras attributed B.E.’s return of GI symptoms to B.E.’s milk
protein allergy. Tr. at 149-50. Food allergies can cause both diarrhea and constipation.15 Id. It
is notable that B.E.’s GI symptoms only returned when Petitioner reintroduced milk into his diet.

Finally, B.E. presented to the ER on December 14, 2015 with difficulty breathing and pale
skin color. Ex. 4 at 2. B.E. had been drinking 40-50 ounces of milk per day. Id. at 3; Tr. at 157.
Dr. Liacouras testified that because of this excessive milk intake combined with his milk protein
allergy, B.E. had become severely anemic. Id. at 157-58, 177. Before B.E. was released from the
hospital, Petitioner was directed to exclude dairy from B.E.’s diet. Ex. 4 at 22. These facts strongly
support the position that B.E. had a milk protein allergy.

b. B.E.’s Low Albumin Levels Support a Diagnosis of Milk Protein Allergy

According to Dr. Liacouras, albumin levels can be low when you have intestinal irritation
or colitis. Tr. at 138. During the course of his medical care, B.E.’s albumin levels were low on
three different occasions. On November 7, 2014, B.E. presented to the Mercy Hospital Emergency
Room because of blood in his stool. Ex. 2 at 25. B.E.’s blood work returned an albumin level of
3.5 g/dL, which was low. Id. at 32. B.E. had changed formula from Nutramigen to Neocate four
to five days previously, but that period of time is not long enough for B.E.’s system to have
normalized. B.E. had been drinking Gentlease and Nutramigen formulas since the end of August
2014. This exposure to milk protein likely caused B.E.’s low albumin level. Further, on August
27, 2015, B.E. saw his physician due to blood and slime in his stool. Ex. 2 at 7. At this point, B.E.
had transitioned to Nutramigen and then to cow’s milk sometime before May of 2015. Id. at 21.
This means he had been consuming milk protein for at least four months. His albumin level was
again reported as low at 3.6 g/dL. Id. at 7. Finally, B.E. was admitted to the ER on December 14,
2015 due to difficulty breathing and pale skin color. B.E.’s albumin was 2.5 g/dL. Ex. 4 at 5.
Significantly, B.E.’s severe anemia in December 2015 cannot explain his low albumin level. Tr.
at 176-77. Accordingly, these low albumin levels, especially when considered in conjunction with
the timing of B.E.’s transition to formula and cow’s milk, support Respondent’s position that B.E.
suffered from a milk protein allergy, and that this allergy caused his symptoms.

Accordingly, I find that Respondent has established that B.E.'s injuries are the likely result
of his milk protein allergy, a factor unrelated to his rotavirus vaccination.

VI. Conclusion

Upon careful evaluation of all the evidence submitted in this matter--including the medical
records, tests, and reports, as well as the experts’ opinions and medical literature--I conclude that
Petitioner has not shown by preponderant evidence that B.E. suffered an intussusception, or that
any of B.E.’s injuries were caused by his rotavirus vaccination. I further find Respondent has
established that B.E. suffered from a milk protein allergy by a preponderance of the evidence.
Accordingly, Petitioner’s claim for compensation is dismissed.

15
Dr. Liacouras testified that approximately 75% of patients with allergic proctocolitis experience diarrhea;
10-15% only have constipation. Tr. at 179.

26
 In the absence of a timely-filed motion for review (see Appendix B to the Rules of the
Court), the clerk shall enter judgment in accord with this decision.16

IT IS SO ORDERED.

s/ Katherine E. Oler
Katherine E. Oler
Special Master

16
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly
or separately) a notice renouncing their right to seek review.

27