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.

6

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

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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