Court Opinion

ID: 9376708
Source: CourtListenerOpinion
Date Created: 2023-03-03 17:01:49.614816+00
Date Added: 2024-06-11T17:17:08.558093
License: Public Domain

In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                        Filed: January 25, 2023

* * * * * * * * *                       * *
                                         * *
LIANG ZHAO,                                 *
Parent and natural guardian                 *
of G.L., a minor,                           *               Unpublished
                                            *
                                            *
              Petitioner,                   *               No. 19-735V
                                            *
v.                                          *               Special Master Gowen
                                            *
SECRETARY OF HEALTH                         *               Dismissal Decision; Severity
AND HUMAN SERVICES,                         *               Requirement; Intussusception.
                                            *
              Respondent.                   *
* * * * * * * * * * * * *
Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for petitioner.
Felicia Langel, U.S. Dept. of Justice, Washington, D.C., for respondent.

                                 DECISION DISMISSING PETITION 1

        On May 17, 2019, Liang Zhao, as parent and natural guardian of G.L., a minor
(“petitioner”), filed a petition for compensation under the National Vaccine Injury Compensation
Program.2 Petitioner alleges that G.L. suffered from intussusception after receiving the third
rotavirus vaccine on November 18, 2016. Petition (ECF No. 1).

        For the reasons set forth before, after a review of the record as a whole, including the
medical records, affidavits, and expert reports, I find by preponderant evidence that the petitioner
has failed to demonstrate that G.L. suffered the residual effects or complications of the alleged
vaccine-related injury for more than six months after the administration of the rotavirus vaccine,

1
  Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a
reasoned explanation for the action in this case, I intend to post it on the website of the United States Court of
Federal Claims. The Court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. Before the opinion
is posted on the Court’s website, each party has 14 days to file a motion requesting 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). An objecting party must provide the Court with a proposed
redacted version of the opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will
be posted on the Court’s website without any changes. Id.
2
 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to 34 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.
as required by the Vaccine Act. See 42 U.S.C. § 300aa-11(c)(1)(D)(i). Therefore, respondent’s
motion to dismiss this petition is hereby GRANTED and the petition is DISMISSED.

   I.      Procedural History

         Petitioner filed the petition for compensation on May 17, 2019. Petitioner also filed
medical records and an affidavit to accompany the petition. See Petitioner’s Exhibits (“Pet.
Exs.” 1-6.
         On November 26, 2019, respondent filed the Rule 4(c) report, recommending against
compensation. Respondent’s (“Resp.”) Report (“Rept.”) (ECF No. 11). Respondent stated that
G.L.’s intussusception, which he developed twelve days following the third dose of the rotavirus
vaccination, does not meet the criteria of the Vaccine Injury Table “ because the
‘[o]nset….[o]ccured with or after the third dose of a vaccine containing rotavirus.’ ” Resp. Rept.
at 4 (citing 42 C.F.R. § 100.3(c)(4)(ii)(A)). Therefore, respondent stated, “petitioner is not
entitled to a presumption of vaccine causation and must proceed on a theory of causation-in-
fact.” Id. Respondent also stated, “….the record does not reflect that petitioner has the
requirements of 42 U.S.C. § 300aa-11(c)(1)(D). In relevant part, that provision requires
petitioner to demonstrate that G.L. “suffered the residual effects of complications of his illness,
disability, injury or condition for more than 6 months after the administration of the vaccine.”
Id. at 6. Respondent stated that “the record does not reflect that G.L. experienced any ongoing
medical issues related to his intussusception.” Id.

       This case was initially assigned to a different special master, who ordered petitioner to
address the six-month severity requirement and to also file an expert report. See Scheduling
Order (ECF No. 17); Scheduling Order (ECF No. 21). Petitioner filed an expert report on
September 16, 2020, from Dr. Thomas Sferra, along with supporting medical literature. Pet. Ex.
11 (ECF No. 25). Respondent filed an expert report f rom Dr. Chris Liacouras on January 15,
2021. Resp. Ex. A. On March 24, 2021, petitioner filed a supplemental expert report from Dr.
Sferra. Pet. Ex. 12.

        The case was reassigned to my docket on December 8, 2021. Notice of Assignment
(ECF No. 44). The undersigned held a status conference on March 9, 2022. During the status
conference, I explained that the record did not demonstrate that G.L. suffered the residual effects
of his intussusception for six-months or more, nor did he have any surgical intervention to repair
the surgical intervention, thus I recommended that petitioner voluntarily dismiss her claim.
Scheduling Order (ECF No. 46).

       The undersigned held another status conference on October 27, 2022, where petitioner
was present, along with her counsel. See Scheduling Order (ECF No. 52). During this status
conference, the undersigned explained the underlying issues with her claim, specifically the lack
of records to support a showing that G.L.’s injury met the severity requirement of the Vaccine
Act. See Scheduling order (ECF No. 53). The undersigned gave the petitioner the opportunity to
voluntarily dismiss her claim or have the respondent file a motion to dismiss.

       On November 30, 2022, petitioner filed a status report stating that she would not
voluntarily dismiss her claim. As such, respondent filed a motion to dismiss on December 28,

                                                 2
2022. Resp. Motion (“Mot.”) (ECF No. 55). Petitioner filed a response to respondent’s motion
on January 17, 2023. Pet. Response (ECF No. 56).

         This matter is now ripe for adjudication.

   II.      Legal Standard

        Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner
may demonstrate that he or she 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 or she suffered an “off-Table”
injury. § 11(c)(1)(C)(ii).

       For either a Table or off-Table injury, petitioners are required to demonstrate that they
meet the Vaccine Act’s six-month severity requirement. A vaccinee must demonstrate that he or
she has: (i) 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 (ii) died from the
administration of the vaccine, or (iii) suffered such illness, disability, injury or condition from
the vaccine which resulted in inpatient hospitalization and surgical intervention. §300aa -
11(c)(1)(D)(i)-(iii).

        The “surgical intervention” language was added to the Vaccine Act in the year 2000 to
allow for recovery for intussusception, which is an intestinal prolapse that is often severe enough
to require surgery but which typically does not include significant residual effects after surgery.
See e.g. Spooner v. Sec’y of Health & Human Servs., No. 13-159V, 2014 WL 504728 (Fed. Cl.
Spec. Mstr. Jan. 16, 2014); Stavridis v. Sec’y of Health & Human Servs., No. 07-261V, 2009 WL
3837479 (Fed. Cl. Spec. Mstr. Oct. 29, 2009).

        In Cloer, the Federal Circuit explained that the six-month severity requirement “is a
condition precedent to filing a petition for compensation.” Cloer v. Sec’y of Health & Human
Servs., 654 F.3d 1322, 1335 (2011), cert. denied, 132 S.Ct. 1908 (2012). A petitioner must
demonstrate that they have satisfied the severity requirement by preponderant evidence. See
Song v. Sec’y of Health & Human Servs., 31 Fed. Cl. 61, 65-66 (1994), aff’d 41 F. 3d 1520 (Fed.
Cir. 1994). Finding that a petitioner has met the severity requirement cannot be based on
petitioner’s word alone, though special masters need not base their findings on medical records
alone. §13(a)(1); see Colon v. Sec’y of Health & Human Servs., 156 Fed. Cl. 534, 541 (2021).

        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 [he or 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, 1322 n.2 (Fed. Cir. 2010) (citations omitted).

       The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. 42 U.S.C. § 300aa-11(c)(2). The special master

                                                 3
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 rep ort 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.” 42 U.S.C. § 300aa-
13(b)(1). The undersigned must weigh the submitted evidence and the testimony of the parties’
offered experts and rule in petitioners’ favor when the evidence weighs in their favor. See
Moberly, 592 F.3d at 1325-26 (“Finders of fact are entitled—indeed, expected—to make
determinations as to the reliability of the evidence presented to them and, if appropriate, as to the
credibility of the persons presenting that evidence”); Althen, 418 F.3d at 1280 (“close calls” are
resolved in petitioner’s favor).

        Medical records contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions. With proper treatment hanging in the balance,
accuracy has an extra premium.” Cucuras v. Sec’y of Health & Human Servs., 993 F. 2d 1525,
1528 (Fed. Cir. 1993); Lowrie v. Sec’y of Health & Human Servs., No. 03-158V, 2006 WL
3734216, at*8 (Fed. Cl. Spec. Mstr. Nov. 29, 2006). Medical records created
contemporaneously with events they describe are presumed to be accurate and complete. Doe/70
v. Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010).

         However, there is no presumption that medical records are complete as to all of a
patient’s conditions, as the Federal Circuit recently “reject[ed] as incorrect the presumption that
medical records are accurate and complete as to all the patient’s physical conditions.”. Kirby v.
Sec’y of Health & Human Servs., 997 F.3d 1378, 1382-83 (Fed. Cir. 2021). After all, “[m]edical
records are only as accurate as the person providing the information.” Parcells v. Sec’y of Health
& Human Servs., No. 03-1192V, 2006 WL 2252749, at *2 (Fed. Cl. Spec. Mstr. July 18, 2006).
And, importantly, “the absence of a reference to a condition or circumstance is much less
significant than a reference which negates the existence of the condition or circumstance.”
Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991) (quoting the decision
below), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992). The Murphy Court also observed that
“[i]f a record was prepared by a disinterested person who later acknowledged that the entry was
incorrect in some respect, the later correction must be taken into account.” Id.

    III.   Evidence Submitted

           a. G.L.’s Medical Records

       G.L. was born on May 17, 2016. Pet. Ex. 3 at 21. On May 31, 2016, G.L. had a
newborn check-up with Dr. Linda DeLessio. Pet. Ex. 3 at 20. Dr. DeLessio noted that G.L. was
being fed every two hours and was voiding and had stools. Id. However, G.L.’s father reported
concern that G.L.’s abdomen was “inflated.” Id. It was noted that G.L.’s respiratory rate was
low. Id. at 21. However, G.L.’s physical exam was normal and he was “progressing as
expected.” Id. at 22. G.L.’s heart murmur was “not heard today,” so an echocardiogram was
delayed. Id. Dr. DeLessio wrote that G.L. was gaining weight well and his exam was normal.
Id.

                                                  4
        G.L. had his two-month well check on July 19, 2016. Pet. Ex. 3 at 23. G.L. was brought
in by his father. Id. He reported that G.L. was breast feeding often, voiding and stooling well
and sleeping well. Id. G.L.’s development screen was ‘within normal limits.” Id. at 24. At this
appointment, G.L. received his first rotavirus vaccination. Id. at 24.

        G.L. had an appointment on August 11, 2016, with Dr. Brian Moshier. Pet. Ex. 3 at 26.
Petitioner reported that G.L. “had been sweating a lot of he received vaccines, about three weeks
ago,” and she also expressed concern that G.L. “has a digestion issue because [he] has been
having a lot of gas and is spitting up with feedings.” Pet. Ex. 3 at 26. Petitioner reported that
G.L. had been spitting up during the two hours after a feeding, but that the spit up was non -
bloody, nonbilious, and non-projectile. Id. Additionally, G.L. had approximately 10 wet diapers
a day and stooling once a day. Id. G.L. was assessed with gastroesophageal reflux disease and
was sent for an echocardiogram for a heart murmur. Id. at 28.

         G.L. returned to Dr. DeLessio on August 25, 2016, after the finding of a secundum ASD
(atrial septal defect) on the echocardiogram. Pet. Ex. 3 at 29. Petitioner reported that G.L. did
not have rapid breathing with feeding, but that he was sweating more around the head and back
of neck when he wakes up. Pet. Ex. 3 at 29. Petitioner reported that G.L. was feeding well, he
was not fussy and had no fever. Id. Dr. DeLessio diagnosed G.L. with secundum ASD and
explained to petitioner that “most small ASDs close by 1-2 years of life without residual
complications.” Id. at 30. Further, Dr. DeLessio noted that G.L. was dressed in two layers of
clothing when the outside temperature was 80 degrees and recommended that dressing G.L. in
one light layer during the summer may help reduce sweating. Id. Additionally, Dr. DeLessio
explained that G.L. was “growing very well” and that his spit ups were infrequent, and he was
gaining weight. Id. Petitioner inquired as to whether it was safe for G.L. to receive his four-
month vaccines given G.L.’s heart condition. Id. Dr. DeLessio “encouraged” petitioner to bring
the information in with her to the next appointment. Id.

        G.L. had his four-month well child exam on September 15, 2016. Pet. Ex. 3 at 32.
Petitioner had concerns for thrush and atopic dermatitis. Id. It was noted that G.L.’s sweating
had decreased, but G.L. was uninterested in bottle feeding and had a recent bout of thrush. Id.
After a physical exam, G.L. was assessed as “progressing as expected.” Id. at 34. At this
appointment, G.L. received multiple vaccinations, including his second rotavirus vaccination.
Id. at 34.

       On October 7, 2016, petitioner and G.L. had an appointment with Dr. Keith Kappel for
“white spots in his mouth.” Pet. Ex. 1 at 46. Petitioner reported that G.L. had been taking
Nystatin for three weeks, but still had spots in his mouth. Id. It was noted that G.L. was given
this medication, but then feeding afterwards and mother was nursing but was not treating herself.
Id.

        On November 18, 2016, G.L. presented to Dr. Kappel for his six -month well child exam.
Pet. Ex. 1 at 41. It was noted that one of G.L.’s ongoing disorders was “heart murmur.” Id.
Under “Nutrition History” it was recorded that G.L. was eating baby food, uses a bottle, and is
also breast fed. Id. Further, G.L. was also consuming Similac Advanced. Id. At this
appointment, he weighed 20 lbs. Id. at 41. Under assessment, G.L. had no abnormal findings

                                                5
and Dr. Kappel recommended that G.L. move to “stage II foods,” and to feed him solids three
times a day. Id. at 42. G.L. was also administered the third rotavirus vaccine, along with the
DTap-Hib-IPV, third does of the hepatitis B vaccine, and the pneumococcal PCV-13. Id. at 43.

      On November 30, 2016, G.L.’s mother called Dr. Kappel’s office and reported that G.L.
was “not eating and crying all the time.” Pet. Ex. 1 at 35. G.L. was seen later that day by Dr.
Kappel and at this time, G.L. had vomited three times and he was fussy. Id. at 30.

        As G.L.’s vomiting continued, he also began to have bloody stools. Pet. Ex. 2 at 96.
Petitioner brought G.L. to the Children’s Hospital of New Orleans emergency department and
reported, “persisted vomiting” and that several hours later G.L. had “strawberry jelly” like stool.
Id. An abdominal ultrasound revealed a small bowel intussusception and G.L. was admitted to
“attempt reduction” with a contrast enema. Id. at 97.

        On December 1, 2016, G.L. was admitted to the hospital and a water-soluble contrast
enema was used to reduce the intussusception. Pet. Ex. 2 at 104. Approximately twelve hours
later, G.L. had a recurrent intussusception, which again was reduced with a wa ter-soluble enema.
Id. at 173. G.L. was discharged on December 3, 2016. On December 6, 2016, G.L. returned to
the hospital emergency department with abdominal complaints. Pet. Ex. 2 at 40. At first an
ultrasound showed what appeared to be a short segment small bowel intussusception, but once
the exam was complete, the intussusception was no longer visualized. Id. at 44. The impression
was “transient small segment small bowel intussusception.”

        On December 28, 2016, G.L. had a follow-up appointment with Dr. David Yu, a pediatric
surgeon, who reviewed G.L.’s past medical history and noted that since December 6th, “G.L. has
done well. At home he seems to be tolerating a regular diet with good bowel function.” Pet. Ex.
2 at 8.

        On February 8, 2017, G.L. had an appointment with Dr. Vickie Pyevich for his heart
condition. Pet. Ex. 6 at 22. Petitioner expressed concern over his septal defects. 3 Id. She also
explained that G.L. enjoyed breast feeding and formula and he was feeding well. Id. Dr.
Pyevich wrote that G.L.’s exam was “suggestive of a small VSD,” but that G.L. was growing
well and had no symptoms of concern. Id. Dr. Pyevich recommended that G.L. have a chest x-
ray and if that is normal, then follow-up can be in one year. Id. Nurse McDonald called
petitioner on February 14, 2017 reporting that G.L.’s chest x-ray was normal. Id. at 26.

        On March 21, 2017, G.L. had a well-child appointment with Dr. Linda DeLessio. Pet.
Ex. 3 at 35. At this appointment, petitioner reported that G.L. was having nursing/formula six
times a day, eating baby foods, but also that G.L. was experiencing some constipation. Id.
Petitioner reported that G.L. was having hard stools and having difficulty with bowel
movements. Id. Dr. DeLessio recommended that petitioner add prune juice to G.L.’s diet. Id. at
37. On May 9, 2017, G.L. had another appointment with Dr. DeLessio. Id. at 43. Petitioner
reported that G.L. was again experiencing constipation and expressed concern that the
intussusception caused G.L.’s constipation. Id. Dr. DeLessio explained that the intussusception

3
    Dr. Pyevich felt that G.L. may also have a small ventricular septal defect (VSD) based on her examination.

                                                           6
would not cause the constipation and recommended a small amount of Miralax for G.L. Id. at
44.

         On July 3, 2017, G.L. had an appointment with Dr. Keith Kappel for diarrhea. Pet. Ex. 1
at 12. During this appointment, G.L.’s mother stated that G.L. had diarrhea with an onset of
three weeks ago. Id. Additionally, she reported that G.L. had been constipated for a “few
weeks” and only had a bowl movement 2 to 3 days. Id. Dr. Kappel’s assessment was “slow
transit constipation” and recommended that G.L. stop using formula, switch to low-fat milk, and
increase his water intake. Id. at 18. The next medical record is from July 28, 2017, where
petitioner called Dr. Kappel’s office regarding “cough, congestion, and running nose.” Pet. Ex. 4
at 11.

        On November 20, 2017, G.L. had a follow-up appointment with Dr. Pyevich for his heart
condition. Pet. Ex. 6 at 32. It was noted that while he does wake up in the middle of the night,
he is growing and developing well. Id. It was noted that G.L. was still breastfeeding at age 18-
months, but it was mostly for comfort. Id. The physical exam was relatively difficult, but his
blood pressure was recorded as normal. Id. at 34. Petitioner expressed concern that G.L. had
hypertension and Dr. Pyevich attempted to explain that there was no evidence of hypertension.
Id.

         On February 19, 2018, G.L. had an appointment with Dr. Catherine Degeeter, pediatric
gastroenterologist. Pet. Ex. 6 at 48. Petitioner self -referred G.L. to the pediatric
gastroenterologist, reporting “alternating constipation and loose stools.” Id. Dr. Degeeter noted
that at six months of age, G.L. experienced an intussusception which was resolved by an enema
and then a recurrence, which was also relieved bya barium enema. Id. Petitioner reported that
G.L.’s “bowel habits changed after the episode of intussusception,” including “loose stools for 3
months at the beginning of last year (2017) and these resolved, now stools have been on the more
firm side.” Id. Petitioner also reported that G.L. had bowel movements every 2-3 days and will
give Miralax to soften stools. Id. Additionally, petitioner reported having concerns that G.L.
was not gaining weight since six months old, however, the growth chart was reviewed and Dr.
Degeeter wrote “his weight is tracking nicely at the 85th percentile.” Id. After a physical exam,
Dr. Degeeter wrote, “Discussed with mother that we can better control his constipation with
proper mixing and use of Miralax. I do not think his constipation is due to his history of
intussusception and as he has not had any further episodes, I do not think at this time it is
necessary to evaluate his GI track any further. Discussed in detail that his growth has been
appropriate.” Id. at 50.

          On March 27, 2018, G.L. was seen by Dr. Benjamin Reinking for his heart condition.
Pet. Ex. 6 at 55. Petitioner, along with G.L.’s father and grandmother attended this appointment.
Id. The family reported “occasional episodes of perioral cyanosis,” and that they were “unsure if
it is triggered by cold or bathing.” Id. G.L. had an EKG and echocardiogram at this
appointment. After the examination, Dr. Reinking diagnosed G.L. with “innocent heart
murmur,” and wrote, “G.L. has a history of a possible ASD and VSD noted o n an echo at three
months of age. He [does] not [have] concerning symptoms that would suggest cardiac problems.
His exam reveals an innocent sounding heart murmur. Echo and EKG done during his visit
today were normal. I reassured [G.L.’s] family that he has a normal heart.” Id. at 57.

                                                7
        On May 18, 2018, G.L. had appointment with Dr. Deepna Kukreja. Pet. Ex. 5 at 16.
Petitioner reported that G.L. had vomiting and diarrhea for three days, with decreased wet
diapers. Id. Petitioner reported G.L. as “fussy” and “fatigued,” along with a decreased appetite.
Id. Under physical exam it noted that G.L., “did not appear exhausted,” and that he was in “no
acute distress.” Id. His bowel sounds were hyperactive. Id. Dr. Kukreja recommended that
G.L. be given Pedialyte or Gatorade in small amounts and to let his stomach rest for about an
hour after vomiting. Id.

      On August 28, 2018, G.L. had a two-year well child appointment with Dr. Sarah
Hartman. Pet. Ex. 5 at 13. At this appointment, it was reported that G.L. had normal bowel
movements daily and had a normal appetite. Id. It was also noted that G.L. had a normal
number of wet diapers and “normal toilet training.” Id.

           b. Expert Reports

                   i. Petitioner’s Expert: Dr. Thomas J. Sferra

       Petitioner submitted two expert reports from Dr. Thomas J. Sferra. Pet. Ex. 11; Pet. Ex.
12. While his two reports discuss vaccine causation, most relevant to this decision is his opinion
about G.L.’s residual symptoms after G.L. experienced the intussusceptions in December 2016.

         Dr. Sferra wrote that “G.L. was a six-month male, infant who developed recurrent
intussusception requiring a contrast enema on two occasions for relief of the condition.” Pet. Ex.
11 at 3. He explained that on November 30, 2016, G.L. developed persistent emesis, he
developed bloody stools and he was taken to a pediatric emergency room “at which tim e an
abdominal ultrasound demonstrated a large ileocecal intussusception extending to the hepatic
flexure. The intussusception was reduced radiologically (enema with water-soluble contrast
agent) on December 1, 2016.” Id. He noted that G.L. developed a recurrence of the
intussusception which also required a radiologic reduction (enema with water-soluble contrast
agent). Id. Dr. Sferra also observed that on December 6, 2020, G.L. again had bowel
movements containing blood and was taken back to the emergency room where ultrasound
showed a self-resolving small bowel-small bowel intussusception. Id. Dr. Sferra wrote, “Since
these events, G.L. has had ongoing concerns with constipation requiring the use of a stool
softener.” Id.

        Dr. Sferra stated that G.L.’s long term medical issues that were related to his
intussusception was his diagnosis of “functional constipation.” Id. at 6. He wrote that,
“Functional disorders of the bowel frequently are triggered by an acute infection or other adverse
process affecting the bowel. This has been frequently described [as] irritable bowel syndrome in
adults and children. However, it is applicable to children in which irritable bowel syndrome with
constipation as an associated symptom can occur.” Id. He concluded, “Thus, G.L.’s ongoing
concerns with constipation can reasonably be related to the acute inflammation following the
vaccine that led to the two episodes of intussusception.” Id.; Pet. Ex. 12 at 3-4.

                  ii. Respondent’s Expert: Dr. Chris Liacouras

                                                8
       Respondent’s expert, Dr. Liacouras does not disagree that G.L. experienced two
intussusceptions in December 2016 twelve days after he received the third dose of the rotavirus
vaccine. Resp. Ex. A at 3.

        Dr. Liacouras opined that G.L.’s functional constipation was unrelated to the
intussusception. Id. at 3. He wrote that “functional constipation is one of the most common
disorders that occurs in infants and toddlers and makes up approximately 15 -20% of all
outpatients seen by pediatric gastroenterologist.” Id. He explained that “The cause of functional
constipation is typically related to dietary intake, toilet training, and a delay in recognition. It is
not caused by intussusception.” Id. Dr. Liacouras stated, “G.L.’s medical history is completely
consistent with the development of functional constipation.” Id. at 4. Dr. Liacouras observed
that two of G.L.’s treating physicians also “explicitly stated that the patient’s intussusception was
not the cause of constipation.” Id. (original emphasis).

        Dr. Liacouras wrote that, “it is certainly possible that intussusception can cause
constipation when it is acutely present and actively causing symptoms. However, once
intussusception is treated and resolved, especially if surgery was not required, no further
episodes occur, and no evidence exists that there was chronic irreversible intestinal damage,
intussusception does not cause chronic constipation.” Id. at 5. Further, he argued that G.L.’s
dietary history, bowel movement history, and response to constipation treatments are all entirely
consistent with functional constipation. Id. at 7. He explained, “G.L.’s pediatrician confirmed
that G.L. had functional constipation which was not related to his intussusception and after
developing constipation, G.L. demonstrated multiple outpatient visits when he was having
normal bowel movements that responded to changes in diet without medical treatment.” Id.

       Dr. Liacouras concluded his report stating, “With regard to [G.L.’s] constip ation, after
the immediate period of intussusception, G.L. had no further episodes of intussusception and no
evidence of chronic anatomic or neuromuscular abnormalities. Instead, G.L.’s constipation was
intermittent, was often related and responsive to dietary changes, always responded to medical
therapy, and was consistent with the vast majority of young children who have functional
constipation." Id.

    IV.     Analysis

        The medical records demonstrate that G.L. received the third rotavirus vaccination on
November 18, 2016. Pet. Ex. 1 at 43. Under the Vaccine Injury Table, intussusception can be a
Table Injury after the first and second dose of the rotavirus vaccine, but not the third. See 42
C.F.R. §§ 100.3(a)(XI)(A), 100.3(c)(4)(A). Therefore, petitioner is not entitled to a presumption
of vaccine causation. Regardless of whether petitioner is alleging a Table or cause-in-fact claim,
petitioners must demonstrate that his alleged injury meets the severity requirement. However,
the medical records and expert opinion do not demonstrate that G.L.’s alleged vaccine-related
injury continued past December 6, 2015.

       Petitioner states that G.L.’s functional constipation was the residual effect of the
intussusception that G.L. suffered as a result of receiving the third rotavirus vaccination, and that

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it continued for more than six months. Pet. Response at 6. Petitioner argues that G.L.’s
functional constipation was “likely triggered by an adverse process affecting the bowel: in this
case it was the intussusception caused by the rotavirus vaccine.” Id.

        Respondent argues that the “petitioner cannot satisfy the six-month severity requirement,
or the alternative severity requirement of inpatient hospitalization and surgical intervention.”
Resp. Mot. at 6. Respondent states, “G.L.’s intussusceptions resolved within a few days, and
there were no sequelae.” Id. Respondent asserts that G.L.’s treating physicians did not attribute
his subsequent constipation to his intussusception. Id. Further, respondent states that G.L.’s
intussusceptions did not require surgical intervention and they resolved with a water soluble
contrast enema. Id. Respondent concludes that “petitioner’s claim does not meet the statutory
severity requirement.” Id.

        The undersigned agrees with respondent. The medical records demonstrate that
approximately twelve days after G.L. received the third dose of the rotavirus vaccine, he suffered
an intussusception. The intussusception likely began on November 30, 2016 , and it was resolved
by a contrast enema on December 1, 2016. See Pet. Ex. 2 at 104. While G.L. did have a
recurrence of the intussusception twelve hours later, that too was also resolved by a contrast
enema. Barium contrast enemas are non-surgical interventions that are used reduce
intussusceptions. 4 It also appears that on December 6, 2016, G.L. had another recurrence of an
intussusception, but it was resolving on its own and no medical intervention was required. See
Pet. Ex. 2 at 8.

        At G.L.’s follow-up appointment with Dr. David Yu, pediatric surgeon on December 28,
2016, it was stated that since the G.L.’s ultrasounds on December 6th, he was “tolerating a
regular diet with good bowel function.” Pet. Ex. 2 at 8. Between December 28, 2016, and
March 21, 2017, the focus of G.L.’s medical appointments was on his heart condition.

        On March 21, 2017, nearly 3 months after the last report of G.L.’s abdominal pain,
petitioner reported that G.L. was experiencing constipation. Pet. Ex. 3 at 35. At this
appointment, Dr. DeLessio weighed G.L. at 23 lbs. His development screen was “within normal
limits.” Id. at 36. Dr. DeLessio recommended that petitioner introduce prune juice into G.L.’s
diet for constipation and urged petitioner to make an appointment with Dr. Pyevich for his
cardiac condition. Id. On May 9, 2017, petitioner brought G.L. to see Dr. DeLessio again with
concerns about constipation. Pet. Ex. 3 at 43. At this appointment, petitioner expressly stated
that she was concerned that the intussusception caused G.L.’s constipation. Id. Dr. DeLessio
explained to petitioner “that intussusception would not cause constipation but it would be
important to control constipation to prevent further complications.” Id. at 3.

       When G.L. was seen by Dr. Kappel on July 3, 2017, G.L. was experiencing diarrhea.
Pet. Ex. 1 at 12. Petitioner also reported that G.L. was constipated for a few weeks. Id. Dr.
Kappel diagnosed G.L. with “slow transit constipation” and recommended that p etitioner stop
using formula for G.L. and switch to low-fat milk, while increasing his water intake. Id. at 18.

4
  An enema is a liquid injected or to be injected into the rectum for the reduction of an intussusception. Dorland’s
Illustrated Medical Dictionary, 33rd Ed. at 615 (2020).

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        Thereafter, it was not until February 2018, when G.L. was seen by a pediatric
gastroenterologist, Dr. Catherine Degeeter. Pet. Ex. 6 at 48. At this appointment, petitioner
reported that G.L. experienced loose stools in the following months after the intussusception, but
then his stools have been “more on the firm side.” Id. After reviewing his medical history and
reviewing G.L.’s growth progress, Dr. Degeeter counseled petitioner on how to better control
G.L.’s constipation with “proper mixing and use of Miralax.” Id. at 50. Additionally, Dr.
Degeeter stated, “I do not think his constipation is due to his history of intussusception and a s he
has not had any further episodes, I do not think at this time it is necessary to evaluate his GI track
any further. Discussed in detail that his growth has been appropriate.” Id.

        Aside from the opinion of Dr. Sferra, two of G.L.’s treating physicians do not associate
his intussusception from December 2016 to his constipation. See Pet. Ex. 3 at 44; Pet. Ex. 6 at
50. In the appointment twenty-two days following his last abdominal ultrasound, G.L. was noted
to be having normal bowel movements and eating well. See Pet. Ex. 2 at 8. The two statements
from the treating physicians, independent from one another reviewed G.L.’s medical history and
examined him, are persuasive evidence that G.L.’s constipation was not a residual effect of the
intussusception he experienced in December 2016. Further, there is no evidence in the medical
records to suggest that his constipation was a result of his intussusception. Additionally, the first
report of G.L.’s constipation came over three months after the intussusception, making it less
likely that his constipation was attributable to the intussusception, rather than something else,
such as dietary changes. Furthermore, Dr. Liacouras persuasively explained that functional
constipation is a very common disorder in infants and is treated with good results in the same
manner in which G.L. was treated. He also explained, consistent with the treating physicians,
that when the constipation occurs remotely from the resolution of the intussusception as was the
case here, the constipation was not caused by the intussusception.

       As such, I am not persuaded by petitioner’s argument that G.L.’s constipation was the
residual effect of the intussusception that occurred twelve days after this third rotavirus
vaccination.

    V.     Conclusion

        After evaluation of the evidence submitted in this case, including the medical records and
expert reports, I find that petitioner has not established by preponderant evidence that she has
met the Vaccine Act’s statutory six-month severity requirement. Accordingly, respondent’s
motion is hereby GRANTED and petitioner’s claim for compensation is DISMISSED.

       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.

         IT IS SO ORDERED.

                                                                      s/Thomas L. Gowen
                                                                      Thomas L. Gowen
                                                                      Special Master

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