VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00800
Package ID: USCOURTS-cofc-1_18-vv-00800
Petitioner: C.G.
Filed: 2018-06-06
Decided: 2021-06-29
Vaccine: RotaTeq rotavirus vaccine (third dose)
Vaccination date: 2016-09-07
Condition: intussusception after third RotaTeq dose; off-Table causation denied
Outcome: denied
Award amount USD: 

AI-assisted case summary:
On June 6, 2018, Scott Germaine filed a petition under the National Childhood Vaccine Injury Compensation Program on behalf of his minor grandson, C.G., alleging that the third dose of the RotaTeq rotavirus vaccine caused C.G. to develop intussusception. C.G. was born on March 7, 2016. He received the first two doses of a rotavirus vaccine at his two-month and four-month well-baby visits, respectively, and was assessed as normal at both visits. On August 9, 2016, C.G. was diagnosed with acute bronchiolitis. By his six-month well-baby visit on September 7, 2016, C.G.'s symptoms had resolved, and he was assessed as normal. He received the third dose of a rotavirus vaccine, which the parties inferred to be RotaTeq, along with other scheduled immunizations. Eighteen days later, on September 25, 2016, C.G. began vomiting and experiencing diarrhea. His diarrhea became bloody, prompting a visit to the emergency department. At the emergency department, C.G. was diagnosed with vomiting, diarrhea, dehydration, and bloody diarrhea. A gastrointestinal panel was positive for C. difficile toxin and norovirus, and negative for adenovirus and E. coli. C.G. was transferred to a hospital for higher-level care, where an ultrasound confirmed intussusception. Attempts at catheter reduction were unsuccessful, and surgery was performed on September 26, 2016, to remove a section of bowel and perform an incidental appendectomy. C.G. was discharged on September 29, 2016, and by an October 18, 2016 follow-up, he was recovering well. Mr. Germaine alleged an off-Table causation-in-fact claim, arguing that the third dose of RotaTeq caused C.G.'s intussusception, proposing an inflammatory mechanism and citing epidemiologic literature. Petitioner's expert, Dr. John Santoro, opined that while the precise mechanism was unknown, epidemiological evidence supported a connection and suggested vaccine virus replication could cause an inflammatory response. Respondent's expert, Dr. Chris Liacouras, challenged Dr. Santoro's interpretation and argued that C.G.'s norovirus infection was a more likely cause. Dr. Santoro died before an expert hearing could be held, and Mr. Germaine elected to proceed on the written record. Special Master Christian J. Moran denied compensation, finding that petitioner had not established a persuasive medical theory connecting the third dose of RotaTeq to intussusception. The Special Master noted that the proposed inflammatory mechanism was too general and that the cited epidemiological studies (Weintraub, Yih, Haber, and Koch) did not demonstrate a significant increased risk of intussusception after the third dose of RotaTeq. Because the first prong of the Althen test failed, the Special Master made no finding on the respondent's alternative causation argument regarding norovirus. Mr. Germaine sought review in the Court of Federal Claims. Judge Stephen S. Schwartz sustained the Special Master's decision on June 29, 2021, finding that the rejection of the inflammatory mechanism was not arbitrary or capricious, as the theory was not specific to the third dose and lacked evidence of C.G. experiencing inflammation. Judge Schwartz also found that the Special Master correctly interpreted the epidemiological studies, noting that Haber showed a negative excess risk for the third dose and Koch's findings for the third dose were statistically insignificant. The motion for review was denied, and judgment was entered for the respondent. Petitioner was represented by Sean F. Greenwood of Greenwood Law Firm. Respondent was represented by Ryan D. Pyles of the U.S. Department of Justice.

Theory of causation field:
Petitioner alleged that the third dose of RotaTeq rotavirus vaccine, administered on September 7, 2016, to C.G. (born March 7, 2016), caused intussusception with onset on September 25, 2016, 18 days post-vaccination. This was an off-Table claim as the Vaccine Injury Table excludes intussusception with onset on or after the third dose of rotavirus vaccine. Petitioner's expert, Dr. John Santoro, proposed a mechanism of vaccine virus replication causing an inflammatory response in intestinal lymphatic tissue, supported by epidemiological literature. Respondent's expert, Dr. Chris Liacouras, disputed this, citing C.G.'s norovirus infection as a more likely cause. Special Master Christian J. Moran denied compensation, finding the proposed mechanism too general and not specific to the third dose, and that epidemiological studies (Weintraub, Yih, Haber, Koch) did not show a significant increased risk after the third RotaTeq dose, thus failing the first prong of the Althen test. Judge Stephen S. Schwartz sustained the denial on June 29, 2021, agreeing that the mechanism was not specific and that the epidemiological evidence, particularly Haber and Koch, did not support an increased risk after the third dose, finding the relative risks to be statistically insignificant. No award was made. Petitioner was represented by Sean F. Greenwood; Respondent by Ryan D. Pyles.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_18-vv-00800-0
Date issued/filed: 2021-03-26
Pages: 16
Docket text: PUBLIC DECISION (Originally filed: 3/9/2021) regarding 62 DECISION of Special Master Signed by Special Master Christian J. Moran. (jmw) Service on parties made.
--------------------------------------------------------------------------------
Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 1 of 16
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
SCOTT GERMAINE, Individually *
and on behalf of his minor grandson, * No. 18-800V
C.G., * Special Master Christian J. Moran
*
Petitioner, *
* Filed: March 9, 2020
v. *
* entitlement; rotavirus vaccine;
SECRETARY OF HEALTH * intussusception.
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Sean F. Greenwood, Greenwood Law Firm, Houston, TX, for petitioner;
Ryan D. Pyles, United States Dep’t of Justice, Washington, DC, for respondent.
PUBLISHED DECISION DENYING COMPENSATION*
Scott Germaine filed a petition for compensation under the National
Childhood Vaccine Injury Compensation Program, 42 U.S.C. § 300aa—10 to 34
(2012), alleging that the third dose of the rotavirus (RotaTeq) vaccine caused his
grandson, C.G., to suffer intussusception. Pet., filed June 6, 2018. Because Mr.
Germaine has not established a persuasive medical theory connecting the third
dose of the RotaTeq vaccine with intussusception, Mr. Germaine is not entitled to
compensation.
* The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,
2002), requires that the Court post this decision on its website. Anyone will be able to access
this decision via the internet (https://www.uscfc.uscourts.gov/aggregator/sources/7). Pursuant to
Vaccine Rule 18(b), the parties have 14 days to file a motion proposing redaction of medical
information or other information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions
ordered by the special master will appear in the document posted on the website.

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 2 of 16
Facts
The parties do not dispute C.G.’s medical history. Pet’r’s Br., filed Mar. 18,
2020, at 1-3; Resp’t’s Br., filed June 9, 2020, at 2-3. Thus, the recitation of facts
will be abbreviated to include only the most relevant events.
C.G. was born on March 7, 2016, without any serious issues. Exhibit 2 at 4.
At a two-month well-baby visit, C.G. was assessed as normal and received the first
dose of a rotavirus vaccine in addition to other routine vaccinations. Exhibit 3 at
37-39. C.G. was again assessed as normal during his four-month well-baby visit,
where he received the second dose of a rotavirus vaccine among others. Id. at 33-
36.
C.G. returned to his pediatrician on August 9, 2016, and Mr. Germaine
reported that C.G. was experiencing congestion, cough, wheezing, rattling in chest,
nasal discharge, fussiness, and fever. Id. at 31-32. The pediatrician diagnosed
C.G. with acute bronchiolitis and prescribed a medication to treat it.
At his six-month well-baby visit on September 7, 2016, C.G. was no longer
suffering from bronchiolitis symptoms and assessed as normal. Id. at 27-29. C.G.
received the third dose of a rotavirus vaccine with his other regularly scheduled
vaccines. Mr. Germaine alleges this dose harmed C.G.
Eighteen days later, on September 25, 2016, Mr. Germaine attested that C.G.
began vomiting and experiencing diarrhea. Exhibit 1 ¶ 4. Mr. Germaine suspected
that C.G. may have had a “stomach flu” because he and another member of the
household had a “stomach flu” earlier that week. Id. After C.G.’s diarrhea turned
bloody, Mr. Germaine realized that something was seriously wrong with C.G. and
took C.G. to the emergency room that afternoon. Id.
At the emergency department, the attending physician ran a gastrointestinal
panel on C.G. and the results came back as a positive for C. difficile toxin and
norovirus but negative for adenovirus and e. coli.1 Exhibit 4 at 15. The physician
diagnosed C.G. with vomiting/diarrhea, dehydration, and bloody diarrhea. Id. at 6.
1 In his brief, Mr. Germaine asserted that the Secretary is arguing that C.G. developed
intussusception due to the adenovirus. Pet’r’s Br. at 14. This assertion appears to be a clerical
mistake because Mr. Germaine correctly stated later in his brief that the Secretary is arguing that
norovirus caused C.G.’s intussusception. Pet’r’s Br. at 16. The Secretary does not appear to
have stated that C.G. suffered from an adenovirus infection, let alone that the adenovirus caused
C.G.’s intussusception, in any of his filings.
2

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 3 of 16
C.G. was transferred to another hospital with the specialists needed for a higher-
level of care. Id. at 5.
After his transfer, an ultrasound verified intussusception as the cause of
C.G.’s gastrointestinal symptoms. Exhibit 5 at 9-10. Doctors unsuccessfully
attempted to reduce C.G.’s bowels by catheter. Id. at 11. At this time, the treating
physician advised Mr. Germaine that C.G. would need surgery to address the
intussusception. Id. The physician admitted C.G. and scheduled his surgery for
the next day. Id.
Intussusception occurs when the bowls either prolapse or telescope in on
itself. Exhibit 6 at 5; exhibit A at 3. This unnatural movement of the bowls results
in an intestinal obstruction causing symptoms of severe stomach pain, vomiting,
and currant jelly stool. Young children under the age of two most frequently suffer
from intussusception.
On September 26, 2016, the surgeon confirmed C.G.’s intussusception,
removed a section of bowel, and performed an incidental appendectomy. Exhibit 5
at 31-33. On September 29, 2016, C.G. was discharged with final diagnoses of
intussusception and status-post laparoscopic appendectomy. Id. at 71-73.
At a follow-up with his pediatrician on October 5, 2016, the pediatrician
recorded the active problem as, “Intussusception - Per dad no rotateq to be given
due to emergency surgery from side effect.”2 Exhibit 3 at 25. The pediatrician did
not comment on the vaccine, and his assessment only stated, “Intussusception –
recovery.” Id.
Mr. Germaine brought C.G. for a post-surgical follow-up on October 18,
2016, reporting that C.G. was eating regularly, having normal bowel movements,
having no pain, and was not having any fever. Exhibit 5 at 123-24. The physician
noted that C.G. was doing well and that he would only need to return as needed.
In the most recently filed records, C.G. suffered from an ear infection in
March 2018 but was well otherwise. Exhibit 26 at 16-18.
2 While the medical record states that C.G.’s father conveyed the information about the
RotaTeq vaccine, the record also states that C.G. was referred by his grandparents for this visit.
It is possible that C.G.’s grandfather actually accompanied him during the October 5, 2016 visit.
3

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 4 of 16
Procedural History
Mr. Germaine presented an off-Table claim that the third dose of a rotavirus
vaccine caused his grandson, C.G, to develop intussusception. Pet., filed June 6,
2018, at 1. Soon thereafter, Mr. Germaine confirmed submission of all medical
records by filing a statement of completion.
Respondent opposed compensation. In the Rule 4 report, respondent argued
that Mr. Germaine had not presented a medical theory to support intussusception
following the third dose of the rotavirus vaccine, and that C.G. had a documented
norovirus infection prior to his intussusception. Resp’t’s Rep., filed Oct. 1, 2018,
at 4-5. At a status conference to discuss the report, Mr. Germaine proposed filing
an expert report from a gastroenterologist to provide a medical theory. Order,
issued Dec. 7, 2018. Finalized expert instructions subsequently issued. Order,
issued Dec. 28, 2018.
On April 9, 2019, Mr. Germaine filed an expert report from Dr. John
Santoro. Dr. Santoro noted that while the exact mechanism for the rotavirus
vaccine to cause intussusception is unknown, epidemiological evidence supported
a connection between rotavirus vaccines and intussusception. Exhibit 6 at 6-9.
On July 9, 2019, the Secretary filed an expert report from Dr. Chris
Liacouras. Dr. Liacouras challenged Dr. Santoro’s interpretation of the
epidemiological evidence and argued that a norovirus infection caused C.G.’s
intussusception. Exhibit A at 5-6.
Mr. Germaine filed a supplemental expert report from Dr. Santoro on
November 14, 2019. Dr. Santoro responded to Dr. Liacouras by reiterating his
prior positions. Exhibit 22. In a status report, the Secretary stated that he did not
intend to file a responsive expert report. Resp’t’s Status Rep., filed Dec. 12, 2019.
Since the expert report phase had concluded, the undersigned outlined the content
for briefing. Order, issued Feb. 4, 2020.
On March 18, 2020, Mr. Germaine filed his brief and moved for a decision
on the record. The Secretary filed his responsive brief on June 9, 2020. Mr.
Germaine filed a reply brief without any substantive arguments but included a
supplemental report from Dr. Santoro that contained substantive arguments.
Exhibit 29. The Secretary stated via informal communications that he considered
the briefing to be closed and did not believe that Dr. Santoro’s most recent
supplemental report raised any new issues.
4

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 5 of 16
After reviewing these submissions, the undersigned wanted to hear oral
testimony from the experts. Order, filed Sep. 2, 2020. However, Mr. Germaine
learned that his expert, Dr. Santoro, had died and Mr. Germaine decided to submit
the case on the papers without retaining another expert. Pet’r’s Status Rep., filed
Nov. 2, 2020. Thereafter, Mr. Germaine filed another motion for ruling on the
record on February 4, 2021. The Secretary responded on February 17, 2021. Mr.
Germaine did not file a reply within the time the Vaccine Rules permit.
This matter is now ready for adjudication.
Standards for Finding Entitlement
A petitioner is required to establish his case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact's existence.” Moberly v. Sec'y of
Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec'y of Health &
Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1379-80
(Fed. Cir. 2009) (reversing special master's decision that petitioners were not
entitled to compensation); see also Lampe v. Sec'y of Health & Human Servs., 219
F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec'y of Health & Human Servs., 9 F.3d
958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge's contention that the
special master confused preponderance of the evidence with medical certainty).
Petitioners bear a burden “to show by preponderant evidence that the
vaccination brought about [the vaccinee’s] 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.”
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
If a petitioner establishes a prima facie case, the Secretary can rebut by
establishing an alternative cause of the petitioner’s injury by a preponderance of
the evidence. Snyder/Harris v. Sec'y of Health & Human Servs., 553 F. App'x 994,
999 (Fed. Cir. 2014). A special master may also consider the evidence of an
5

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 6 of 16
alternative cause when evaluating petitioner’s prima facie case. Stone v. Sec'y of
Health & Human Servs., 676 F.3d 1373, 1380 (Fed. Cir. 2012).
Analysis
A critical issue is whether Mr. Germaine can establish a medical theory
connecting the third dose of a rotavirus vaccine to intussusception. The Secretary
also offers a norovirus infection as an alternative cause of C.G.’s intussusception.
As background for analyzing the rotavirus vaccine at issue, the history of
rotavirus vaccines helps to understand which rotavirus vaccine(s) the medical
literature is addressing. See Carda v. Sec’y of Health and Human Servs., No. 14-
191V, 2017 WL 6887368 (Fed. Cl. Spec. Mstr. Nov. 16, 2017). The first rotavirus
vaccine, RotaShield (RV4), was approved in 1998 (but then withdrawn in 1999)
and was administered in three doses.3 The second rotavirus vaccine, RotaTeq
(RV5), was approved in 2006 and is administered in three doses.4 The third
rotavirus vaccine, Rotarix (RV1), was approved in 2008 and is administered in two
doses. Exhibit 9 (Rotarix Package Insert).
The Secretary considered the epidemiological literature cited in this case
when adding the first two doses of the available rotavirus vaccines to the Vaccine
Table. Resp’t’s Br. at 9 n.9 (citing National Vaccine Injury Compensation
Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the
Vaccine Injury Table, 80 Fed. Reg. 35848 (June 23, 2015) (codified at 42 C.F.R. §
100.3)). The Secretary separately discussed the evidence supporting adding the
RotaTeq and Rotarix vaccines to the Vaccine Table. 80 Fed. Reg. 35848.
Since the rotavirus vaccines differ, it is relevant to determine which
rotavirus vaccine C.G. received. Broekelschen v. Sec'y of Health & Human Servs.,
618 F.3d 1339, 1345 (Fed. Cir. 2010) (“petitioner must provide a reputable
medical or scientific explanation that pertains specifically to the petitioner's case”);
Davis v. Sec'y of Health & Human Servs., No. 07-451V, 2010 WL 1444056, at
*11 (Fed. Cl. Spec. Mstr. Mar. 16, 2010) (finding that petitioner must establish that
3 Rotavirus Vaccine (RotaShield®) and Intussusception, Center for Disease
Control and Prevention, https://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-
rotashield-historical.htm# (concurrently filed as court exhibit 1001).
4 RotaTeq Package Insert, Merck & Co., Inc.,
https://www.merck.com/product/usa/pi circulars/r/rotateq/rotateq pi.pdf
(concurrently filed as court exhibit 1002).
6

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 7 of 16
information about one vaccine is transferable to another vaccine), mot. for rev.
denied, 94 Fed. Cl. 53 (2010), aff'd, 420 F. App'x 973 (Fed. Cir. 2011). While the
vaccine administration records do not specify which brand of rotavirus vaccine
C.G. received, the person accompanying C.G. at the October 5, 2016 appointment
reported that C.G. should receive no RotaTeq vaccinations. Exhibit 3 at 25. It can
also be inferred that C.G. received RotaTeq because RotaTeq was the only three-
dose rotavirus vaccine being offered during the relevant time period.
Having found that C.G. received the RotaTeq vaccine, the undersigned turns
to whether Mr. Germaine has established a medical theory connecting the third
dose of the RotaTeq vaccine and intussusception.
A. Althen Prong One – Medical Theory
1. Arguments and Evidence concerning a Medical Theory
Mr. Germaine’s attempt to meet his burden of proof to establish that the
third dose of the RotaTeq vaccine can cause intussusception relies upon two
different methods.5 First, Mr. Germaine supports his position by offering Dr.
Santoro’s opinion to propose a medical theory. Second, Mr. Germaine offers
epidemiologic evidence that purportedly shows an increased risk of intussusception
following the third dose of rotavirus vaccine.
For a biological mechanism on how the third dose of the RotaTeq vaccine
can cause intussusception, Mr. Germaine is not clear. Mr. Germaine recognizes
that the mechanism is unknown but also proposes that intussusception is caused by
an inflammatory response in the lymphatic tissue or intestines from the replication
5 In his brief, Mr. Germaine presented contradictory positions on the evidentiary standard
of a medical theory. Mr. Germaine initially presented the preponderance of the evidence
standard for a medical theory from Althen but then asserted that a medical theory need only be
biologically plausible. Compare Pet’r’s Br. at 4 with Pet’r’s Br. at 5 (citing Andreu v. Sec’y of
Health and Human Services, 569 F.3d 1367, 1375 (Fed. Cir. 2009)). However, Dr. Santoro more
clearly stated his opinions about the medical theory to “a reasonable degree of medical and
scientific probability” and to “a high degree of medical certainty.” Exhibit 6 at 11. Thus, despite
the discrepancy, Mr. Germain appears to be seeking to establish his medical theory in line with
the level of proof confirmed by the Federal Circuit. Boatmon v. Sec’y of Health & Human
Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (holding that a “plausible” medical theory did not
satisfy petitioner’s burden of proof); see also Kottenstette v. Sec’y of Health & Human Servs.,
No. 15-1016V, 2020 WL 953484, at *3 (Fed. Cl. Feb. 12, 2020) (deeming the “biologic
credibility” standard as akin to the invalid “plausibility” standard and striking it down in
accordance with Boatmon), appeal docketed No. 2020-2282 (Fed. Cir. Sep. 17, 2020).
7

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 8 of 16
of the rotavirus. Pet’r’s Br. at 8 (citing exhibit 10 at 4), 12-13 (citing exhibit 15 at
7).6
The Secretary agrees that the biological mechanism is unknown but does not
address Mr. Germaine’s proposed mechanism of “inflammatory response.”
Resp’t’s Br. at 8-9; exhibit A at 5. Rather than focus on the mechanism, the
Secretary noted that the relationship between some (but not all) doses of rotavirus
vaccines and intussusception has been established by epidemiology. Resp’t’s Br.
at 8-9. When amending the Vaccine Table, the Secretary believed that the time
ranges for intussusception following the first two doses of the rotavirus vaccines
(1-21 days) were “generous.” 80 Fed. Reg. at 35848. On the broadest level, by
placing some doses of the rotavirus vaccines on the Vaccine Table, the Secretary
has implicitly acknowledged that a biological mechanism of rotavirus vaccines
causing intussusception exists in some circumstances. However, a biological
mechanism is not the end, because the Vaccine Table distinguishes between the
rotavirus vaccine doses based on epidemiology. The undersigned finds that Mr.
Germaine has not carried his burden of proof based on the biological mechanism
alone and now looks to the epidemiological evidence.
Beyond proposing a biological mechanism, Mr. Germaine cites
epidemiological evidence to support a connection between the third dose of the
RotaTeq vaccine and intussusception. While the undersigned has reviewed and
considered all the medical literature, the following articles are the most substantive
evaluations of the relevant issue. The list of articles summarized below does not
include studies solely focused on the (two-dose) Rotarix vaccine. See Appendix 1.
Mr. Germaine has not presented any persuasive explanation for why studies about
a two-dose rotavirus vaccine inform an analysis of a vaccine given in three doses.
Thus, this literature focused solely on the Rotarix vaccine has little impact on the
issue of adverse effects following the third dose of the RotaTeq vaccine. See
Kottenstette v. Sec'y of Health & Human Servs., No. 15-1016V, 2020 WL 953484,
at *5 (Fed. Cl. Feb. 12, 2020) (studies related to one formulation of a vaccine
cannot automatically be attributed to a different formulation of the vaccine).
6 To support this mechanism, Mr. Germaine also cites, without discussion, exhibits 7, 10,
11. Pet’r’s Br. at 8 n.2. These citations do not add any support to Mr. Germaine’s proposed
mechanism. Exhibit 7 is Dr. Santoro’s curriculum vitae, exhibit 10 (Patel) was already cited in
the body of Mr. Germaine’s brief, and exhibit 11 (Greenberg) discusses Patel but does not
address a biological mechanism.
8

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a) Weintraub (exhibit 12)
Weintraub accessed medical records from several integrated health care
organizations to identify intussusception after rotavirus vaccinations. Weintraub
searched for occurrences of intussusception in the medical records and followed
patients with weekly updated records to track any adverse events. Weintraub
compared the risks between the (two-dose) Rotarix vaccine (over 200,000 doses)
and the (three-dose) RotaTeq vaccine (nearly 1.3 million doses). Exhibit 12 at 1.
Weintraub reached different conclusions for the different vaccines.
Following the Rotarix vaccine, risk of intussusception increased significantly. But,
following the RotaTeq vaccine, there was no significant increased risk of
intussusception. Id. at 6-7. Qualifying the conclusion about Rotarix vaccine,
Weintraub noted that the increased risk of intussusception could be a result of
chance due to the small number of intussusception cases. Id. at 7.
Mr. Germaine focused entirely on Weintraub’s conclusion about the Rotarix
vaccine without addressing the qualification that the increased risk of
intussusception may be entirely a result of chance. Pet’r’s Br. at 6-7. Moreover,
Mr. Germaine does not even mention Weintraub’s conclusion that there was no
significant increased risk of intussusception following the RotaTeq vaccine, the
vaccine relevant to this case.
b) Yih (exhibit 13, A-4)
Yih used data from three American health insurance carriers to study
instances of intussusception. Yih identified the instances through procedural and
diagnostic codes. Medical record review then confirmed the rotavirus vaccination
and the intussusception events.
Yih primarily concluded that “there was no significant increase in reporting
after dose 2 or dose 3 [of the RotaTeq vaccine].” Exhibit 13 at 1. Yih did qualify
that conclusion adding that “an increased risk associated with [the second and
third] doses cannot be ruled out, given the overlapping confidence intervals of the
risk estimates for doses 1, 2, and 3.” Id. at 7.
Mr. Germaine appears to have incorrectly characterized the primary
conclusion in Yih relating to the third dose of rotavirus vaccine stating that,
“nearly all the results … yielded a statistically significant increase in attributable
risk of intussusception after rotavirus infection.” Pet’r’s Br. at 12. As noted
above, Yih found no significant increased risk of intussusception following the
third dose of RotaTeq vaccine. While Mr. Germaine highlighted that Yih noted “a
major challenge in studying rotavirus vaccines and intussusception is the strong
9

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 10 of 16
confounding effect of age,” exhibit 13 at 2, the Secretary countered that Yih
accounted for age in the statistical analysis. Resp’t’s Br. at 10-11 (citing exhibit 13
at 3-4).
c) Haber (exhibit 8, A-7)
Haber is a statistical analysis of intussusception events reported to the
Vaccine Adverse Event Report Systems (VAERS). Haber analyzed
intussusception events related to the three-dose rotavirus vaccine, RotaTeq, and to
the two-dose rotavirus vaccine, Rotarix. Haber focused on determining whether
the incidence of intussusception increased after a rotavirus vaccine, how many
days after, and after which doses. Exhibit 8 at 1.
Haber concluded that “there was no significant increase in reporting after
dose 2 or dose 3 [of the RotaTeq vaccine].” Id. Haber concluded that there only
was only a small increase in intussusception events for three to six days after the
first dose of the RotaTeq vaccine.7
Mr. Germaine concedes that the VAERS data analyzed in Haber is “not as
reliable as controlled studies,” but asserts that the data shows a “consistent
relationship between rotavirus vaccine and intussusception.” Pet’r’s Br. at 7. Mr.
Germaine does not address Haber’s conclusion that there was no significant
increase in intussusception after the third dose of the RotaTeq vaccine.
d) Koch (exhibit 14, A-6)
Koch is a systemic literature review and meta-analysis of studies on the
relationship between rotavirus vaccines and intussusception. Koch used the data
underlying these studies to calculate the risk of intussusception from rotavirus
vaccine. Some of the studies underlying Koch’s analysis were cited by the parties:
Haber (exhibit 8), Patel (exhibit 10), Yih (exhibit 13), and Escolano (exhibit A-5).
Koch concluded that “there is no increase in risk after the third dose of the
[RotaTeq] vaccine.” Exhibit 14 at 6. Koch does not list any attributable risk for
the third dose in a table of calculations. Id., Table 2. In the “Key Messages”
section, Koch does not mention any risk of intussusception from the third dose of
the RotaTeq vaccine. Id. at 7.
7 Because there were insufficient numbers of intussusception events reported after the
Rotarix vaccine, Haber was unable to conduct a statistical analysis and could only offer a
descriptive analysis.
10

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 11 of 16
Mr. Germaine apparently disputes Koch’s conclusion stating that Koch
“found an increase in risk of intussusception after all three doses of the [rotavirus]
vaccination.” Pet’r’s Br. at 12 (citing exhibit 14 at 5). Mr. Germaine does not
explain why Koch’s conclusion is incorrect or how it can co-exist with his own
conclusion. From Mr. Germaine’s citation, he may be referencing Koch’s
statement that “the pooled estimate of the [relative risk] after the third dose of RV5
was 1.14 [0.75; 1.74].” Exhibit 14 at 5. Neither Mr. Germain nor Dr. Santoro
explain the significance of this quotation or anything other statistical calculations
made by Koch.
The undersigned finds that the weight of epidemiological evidence does not
support the third dose of RotaTeq vaccine causing intussusception for any period
of time following vaccination, let alone eighteen days following vaccination.
2. Evaluation of Evidence concerning the Medical Theory
The weight of epidemiological evidence does not support the third dose of
RotaTeq vaccine causing intussusception for any period of time following
vaccination, let alone eighteen days following vaccination. For a lengthy
discussion of the value of epidemiologic studies in the Vaccine Program, see Tullio
v. Sec’y of Health & Human Servs., No. 15-51V, 2019 WL 7580149, at *5-8 (Fed.
Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149 Fed. Cl. 448, 475 (2020).
Mr. Germaine admitted that the biological mechanism for rotavirus vaccine
causing intussusception is unknown and presented minimal evidence to support a
mechanism. The undersigned finds that Mr. Germaine has not established a
persuasive theory by a preponderance of the evidence and, thus, he cannot
establish all the elements to prevail on his claim.
B. Alternative Causation
The Secretary argued in the alternative that C.G. developed intussusception
because of his norovirus infection. Resp’t’s Br. at 16. Mr. Germaine admitted that
he and another member of the household were sick with a gastrointestinal illness
days prior to C.G. developing diarrhea and vomiting. Exhibit 1 ¶ 4. C.G. tested
positive for norovirus on the day that he developed his symptoms. Exhibit 4 at 15.
The Secretary asserted that norovirus has been associated with severe
gastrointestinal symptoms, including intussusception. Respt’s Br. at 17 (citing
exhibit A-10 (Petragnani) at 8, exhibit A-11 (Okimoto) at 3); exhibit A at 4.
Addressing the Okimoto study, Dr. Santoro noted that few of the patients with
intussusception also had norovirus (4 of 44) and suggested that even this
correlation may be exaggerated since norovirus is a very common infection.
11

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 12 of 16
Exhibit 22 at 4. Dr. Santoro emphasized that the adenovirus in the Okimoto study
showed a much higher correlation with intussusception (22 of 44) than norovirus.
Id. Mr. Germaine critiqued the literature review in Petragnani for including a
majority of data about patients five years or older, not stating a definition of
intussusception to confirm diagnosis, and finding only four papers (of 176
reviewed) that mentioned intussusception. Pet’r’s Br. at 16-17.
Because Mr. Germaine has not carried his burden regarding the elements of
his case, the burden has not shifted to the Secretary to present an alternative cause
for C.G.’s intussusception. LaLonde v. Sec’y of Health & Human Servs., 746 F.3d
1334, 1340 (Fed. Cir. 2014). Accordingly, the undersigned reaches no finding as
to whether norovirus can cause intussusception.
Conclusion
Mr. Germaine has not established that he is entitled to compensation on
behalf of C.G. The Clerk’s Office is directed to enter judgment in accord with this
decision unless a motion for review is filed.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
12

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 13 of 16
Appendix 1:
Medical literature that substantively analyzes
the three-dose RotaTeq (RV5) vaccine
Citation
Exhibit #
Penina Haber et al., Intussusception After Rotavirus Vaccines
8, A-7
Reported to US VAERS, 2006–2012, 131 Pediatrics 1042 (2013).
Eric Weintraub et al., Risk of Intussusception after Monovalent
12
Rotavirus Vaccination, 370 New Engl. J. Med. 513 (2014).
W. Katherine Yih, Intussusception Risk after Rotavirus Vaccination
13, A-4
in U.S. Infants, 370 New Engl. J. Med. 503 (2014).
Judith Koch, The Risk of Intussusception after Rotavirus
Vaccination- a systemic literature review and meta-analysis, 114
14, A-6
Dtsch Arztebl. Int. 255 (2017).
Catherine Yen, Rotavirus vaccination and intussusception – Science,
surveillance, and safety: A review of evidence and recommendations
15 for future research priorities in low and middle income countries, 12
Hum. Vacc. & Immunotherapeutics 2580 (2016).
Stephan Foster, Rotavirus Vaccine and Intussusception, 12 J. Pedia.
21 Pharmacological Therapeutics 4 (2007).
Sylvie Escolano et al., Intussusception risk after RotaTeq
vaccination: Evaluation from worldwide spontaneous reporting data
A-5
using a self-controlled case series approach, 33 Vaccine 1017 (2015).
Guadalupe Quintero-Ochoa et al., Viral agents of gastroenteritis and
their correlation with clinical symptoms in rotavirus-vaccinated
A-9
children, 73 Infect., Genet. & Evol. 190 (2019).
13

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 14 of 16
Appendix 2:
Medical literature that does not substantively analyze
the three-dose RotaTeq (RV5) vaccine
Citation Vaccine Analyzed
Exhibit #
(if any)
Rotarix® Package Insert, GlaxoSmithKline Two-dose Rotarix
9
(2019). vaccine
Manish Patel et al., Intussusception Risk and
Health Benefits of Rotavirus Vaccination in Two-dose Rotarix
10
Mexico and Brazil, 364 New Engl. J. Med. vaccine
2283 (2011).
Harry Greenberg, Rotavirus Vaccination and
Two-dose Rotarix
11 Intussusception — Act Two, 364 New Engl. J.
vaccine
Med. 2354 (2011).
Kelly Warfield et al., Rotavirus Infection
Enhances Lipopolysacchande-Induced Three-dose
16
Intussusception in a Mouse Model, 80 J. Rotashield vaccine
Virology 12377 (2006).
Christine Robinson et al., Evaluation of
Anatomic Changes in Young Children with
Three-dose
17 Natural Rotavirus Infection: Is Intussusception
Rotashield vaccine
Biologically Plausible?, 189 J. Infect. Disease
1382 (2004).
Shinichiro Hirokawa, Ileoileal Intussusception
and Ileal Stricture Associated with Necrotizing
18 none
Enterocolitis in a Premature Infant: Report of a
Case, 31 Surg. Today 1097 (2001).
Emrah Aydin, Intussusception in a preterm
19 none
newborn, 59 Pedia. & Neonatology 312 (2018).
Jeannette Guarner et al., Intestinal
Intussusception Associated With Adenovirus
20 none
Infection in Mexican Children, 120 Am. J.
Clin. Pathol. 845 (2003).8
8 Mr. Germaine submitted an incomplete version of this exhibit that contains little text.
Upon review of the complete article, Guarner discusses an association between adenovirus and
14

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 15 of 16
Jae Hyun Park et al., Intussusception
23 Associated With Pseudomembranous Colitis, none
46 J. Pedia. Gastro. & Nutrition 470 (2008).9
Anthony Manning, Intussusception in Infants
and Children in Pediatric Gastrointestinal and
A-1 none
Liver Disease (Robert Wyllie et al. eds., 5th ed.
2016) at 607.
H.M.L. Carty, Paediatric emergencies: non-
A-2 traumatic abdominal emergencies, 12 Europ. none
Radiol. 2835 (2002).
Shobhit Jain et al., Child Intussusception,
A-3 NCBI Bookshelf, National Library of none
Medicine, National Institutes of Health (2019).
Z.A. Marsh et al., The unwelcome houseguest:
secondary household transmission of
A-8 none
norovirus, 146 J. Epidemiol. Infect. 159
(2018).
Mariska Petrignani et al., Chronic sequelae and
severe complications of norovirus infection: A
A-10 none
systematic review of literature, 105 J. Clin.
Virology 1 (2018).
Satoshi Okimoto et al., Association of viral
isolates from stool samples with
A-11 none
intussusception in children, 15 Int. J. Infect.
Diseases e641 (2011).
David Galloway et al., Infectious Diarrhea,
Clostridium Difficile in Pediatric
A-12 none
Gastrointestinal and Liver Disease (Robert
Wyllie et al. eds., 5th ed. 2016) at 458.
Priya Farooq et al., Pseudomembranous colitis,
A-13 none
61 Disease-a-Month 181 (2015).
Evon Zoog et al., Adult Intussusception
A-14 none
Caused by Ileocecal Clostridillm difficile
intussusception but does not address any vaccines. A complete copy of the Guarner article is
filed concurrently as court exhibit 1003.
9 While Mr. Germaine cited the first author of exhibit 23 to be J. Kim, the first author
actually appears to be Jae Hyun Park.
15

Case 1:18-vv-00800-SSS Document 63 Filed 03/26/21 Page 16 of 16
Pseudomembranous Colitis, 82 Am. Surg.
E153 (2016).
Gé-Ann Kuiper et al., Clostridium difficile
A-15 infections in young infants: Case presentations none
and literature review, 10 IDCases 7 (2017).
16

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_18-vv-00800-1
Date issued/filed: 2021-07-29
Pages: 5
Docket text: JUDGE VACCINE REPORTED OPINION AND ORDER reissuing Judge Vaccine Order/Opinion initially filed June 29, 2021 (ECF No. 67) denying Petitioner's Motion for Review and Sustaining the Decision of the Special Master. Signed by Judge Stephen S. Schwartz. (cmc) Service on parties made.
--------------------------------------------------------------------------------
Case 1:18-vv-00800-SSS Document 70 Filed 07/29/21 Page 1 of 5
In the United States Court of Federal Claims
No. 18-800V
(Filed Under Seal: June 29, 2021)
(Reissued: July 29, 2021)
FOR PUBLICATION
***************************************
SCOTT GERMAINE, Individually *
and on behalf of his minor grandson, *
C.G., *
*
Petitioner, *
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
***************************************
OPINION AND ORDER
Petitioner Scott Germaine seeks relief under the National Childhood Vaccine
Injury Compensation Program, 42 U.S.C. § 300aa-10 to 34, on behalf of his grandson
C.G., who experienced intussusception after receiving the third dose of a rotavirus
vaccine.1 The Special Master denied the petition based on a finding that Mr.
Germaine “has not established a persuasive medical theory connecting the third dose
of the [rotavirus] vaccine with intussusception[.]” Special Master’s Decision (“SMD”)
at 1 (ECF 62). That conclusion was not arbitrary or capricious, and is therefore
SUSTAINED.
To obtain compensation under the National Childhood Vaccine Injury
Compensation Program, a petitioner must prove that a vaccine caused an injury.
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). There
are two ways to show causation: (1) through “a statutorily-prescribed presumption of
causation upon a showing that the injury falls under the Vaccine Injury Table (‘Table
injury’),” id. (citing 42 U.S.C. § 300aa-14(a)), or (2) by proof of causation in fact “where
the complained-of injury is not listed in the Vaccine Injury Table (‘off-Table injury’),”
 This Opinion was issued under seal on June 29, 2021. The parties were directed to propose redactions
by July 13, 2021. No proposed redactions were submitted. The Court hereby releases publicly the
Opinion and Order of June 29 in full.
1 This Court has jurisdiction. See 42 U.S.C. §§ 300aa-11(c), 300aa-16(a). Mr. Germaine timely moved
for review. See 42 U.S.C. § 300aa-12(e)(1).

Case 1:18-vv-00800-SSS Document 70 Filed 07/29/21 Page 2 of 5
id. (citing 42 U.S.C. §§ 300aa-13(a)(1), 300aa-11(c)(1)(C)(ii)(I)). For off-Table injuries,
causation in fact has three elements: “(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.2 The sole question presented by the
motion for review — and the only issue discussed by the Special Master — is whether
Mr. Germaine satisfied the first of those elements.
Intussusception between 1 and 21 days after a child’s first or second dose of a
rotavirus vaccine is a “Table injury” where causation is presumed. 42 C.F.R.
§ 100.3(a)(XI) (vaccine table). But intussusception after the third dose is not. See 42
C.F.R. § 100.3(c)(4)(ii)(A) (“For purposes of paragraph (a) of this section, the following
shall not be considered to be a Table intussusception: … Onset that occurs with or
after the third dose of a vaccine containing rotavirus[.]”); see also National Vaccine
Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus
Vaccines to the Vaccine Injury Table, 80 Fed. Reg. 35848, 35849 (June 23, 2015) (“The
definition for presumption of vaccine causation only applies to the first and second
dose of vaccine, and excludes intussusception occurring with or after the third dose.
The third dose of rotavirus vaccines lacks sufficient evidence showing risk.”). Plaintiff
must therefore prove causation in fact by preponderance of the evidence. See, e.g.,
Althen, 418 F.3d at 1278.
One way to show causation in fact is by establishing a “probable” biological
mechanism for how the third dose of the rotavirus caused C.G.’s intussusception.
Knudsen, 35 F.3d at 548–49. Mr. Germaine argues that intussusception could be
caused by an “inflammatory response” to the rotavirus vaccine, Pet.’s Mot. for Rev. at
5 (ECF 64), but the Special Master found that Mr. Germaine “has not carried his
burden of proof based on the biological mechanism alone,” SMD at 8, a factual
conclusion that should be upheld unless arbitrary or capricious. Munn v. Sec’y of Dep’t
of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992); 42 U.S.C. § 300aa-
12(e)(2)(B).
The Special Master did not err. Beyond the generic reference to
“inflammation,” little additional explanation appears in the Motion for Review or in
the record before the Special Master. Without more detail, Mr. Germaine’s theory is
not specific to the third dose of the rotavirus vaccine, and possibly not even to
rotavirus vaccines as opposed to other vaccines. Nor is there any evidence that C.G.
personally experienced inflammation that caused intussusception. See Knudsen, 35
F.3d at 549. Mr. Germaine’s proposed mechanism thus cannot be a “probable” one.
Id. at 548–49. It is only a hypothesis, a theoretical possibility. Although proof of
2 The government can rebut proof of causation by showing, “also by a preponderance of evidence, that
the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (quoting
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)); see 42 U.S.C § 300aa-
13(a)(1)(B).
- 2 -

Case 1:18-vv-00800-SSS Document 70 Filed 07/29/21 Page 3 of 5
causation does not “require identification and proof of specific biological
mechanisms,” id. at 549, “a ‘plausible’ or ‘possible’ causal theory” is not enough, see
Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019); see
also Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir.
2010) (“[A] petitioner must provide a reputable medical or scientific explanation that
pertains specifically to the petitioner’s case[.]”).
Causation can also be shown by epidemiological evidence, i.e., by connecting
medical literature about vaccine complications to a patient’s clinical record. Knudsen,
35 F.3d at 549 (explaining that “causation can be found in vaccine cases based on
epidemiological evidence and the clinical picture regarding the particular child
without detailed medical and scientific exposition on the biological mechanisms”). Mr.
Germaine identified several studies purportedly showing a risk of intussusception
after rotavirus vaccines. The Special Master discussed several of those studies, but
concluded that none of them showed an association between the third dose of a
rotavirus vaccine and intussusception. SMD at 11. That conclusion, likewise, must be
upheld unless arbitrary or capricious. 42 U.S.C. § 300aa-12(e)(2)(B).
Mr. Germaine claims the Special Master misinterpreted two studies.3 First, he
proposes a different reading of Haber, et al., Intussusception After Rotavirus Vaccines
Reported to US VAERS, 2006-2012, 131 Pediatrics 1042 (2013) (ECF 21). Mr.
Germaine claims the Special Master overlooked Haber’s finding that “out of the 584
confirmed cases of intussusception after [the rotavirus vaccine with a three-dose
protocol], 29% (169 reports) were reported after dose 3.” Pet.’s Mot. for Rev. at 5.
That argument makes little sense. If instances of intussusception were equally
distributed across a three-dose vaccine, one would expect each dose to be associated
with one-third of the intussusception cases. The fact that the third dose of the
rotavirus vaccine is associated with slightly less than a third of the reported
intussusception cases — especially without any statistical analysis — does not
advance Mr. Germaine’s argument that Haber found “an increased risk of
intussusception after the third dose[.]” Id.
3 Any objections to the Special Master’s analysis of other studies are forfeited. See RCFC App. B, Rule
24(b)(1) (requiring that motions for review of special master decisions must “fully and specifically state
and support each objection” to the special master’s opinion); Yalacki v. Sec’y of Health & Hum. Servs.,
146 Fed. Cl. 80, 92 n.5 (2019). Although I need not reach the issue, the weight of the remaining
evidence would likely support the Special Master’s conclusion concerning causation even if Mr.
Germaine’s objections were meritorious. See Hines v. Sec’y of Dep’t of Health & Hum. Servs., 940 F.2d
1518, 1526 (Fed. Cir. 1991) (“[E]ven if it was error, it was harmless because, as explained below, the
special master’s decision was based on a number of factors and [petitioner] has not shown that reliance
on the judicially noticed incubation period derived from the textbook was likely critical to the result.”);
Doe/11 ex rel. Child/Doe/11 v. Sec’y of Dep’t of Health & Hum. Servs., 87 Fed. Cl. 1, 12 (2009) (“Even
removing consideration of the skewed study and the Special Master’s extrapolation of [an infant’s]
length, substantial evidence supports the Special Master’s conclusion that Petitioners failed to prove
a prima facie case[.]”), aff”d sub nom. Doe v. Sec’y of Health & Hum. Servs., 601 F.3d 1349 (Fed. Cir.
2010).
- 3 -

Case 1:18-vv-00800-SSS Document 70 Filed 07/29/21 Page 4 of 5
More importantly, Mr. Germaine ignores Haber’s analysis of the raw numbers.
Haber calculated the “excess risk” of intussusception associated with rotavirus
vaccinations. Haber at 1044. Excess risk is a method of describing how a given risk
factor affects the likelihood of death or disease compared with the background rate.
Excess risk is derived from the related concept of “relative risk,” which is “[t]he ratio
of the risk of disease or death among people exposed to an agent to the risk among
the unexposed.” Fed. Jud. Ctr., Reference Manual on Scientific Evidence 627 (3d Ed.
2011). “A relative risk of 1 indicates no association between association and disease.”
Id. Excess risk is equal to relative risk minus 1.0, such that a positive number means
a positive association between the risk factor and a given outcome, and a negative
number means a negative relationship. Haber found that while the first and second
doses were associated with a modestly positive excess risk (0.74 and 0.21 per 100,000,
respectively), the third dose was associated with a negative excess risk (-0.16 per
100,000), i.e., a reduction in the risk of intussusception. Haber at 1046, 1047.
That excess risk figure, moreover, has to be taken with its statistical context.
Haber found that the excess risk associated with the third dose of the rotavirus
vaccine had a “confidence interval” of –0.38 to 0.27. Id. A “confidence interval” is ‘[a]
range of values … within which the true value is likely to fall[.]” Reference Manual
on Scientific Evidence 621. A confidence interval that straddles a relative risk of 1.0
(that is, an excess risk of 0.0) is “statistically insignificant,” see id., meaning that it is
statistically indistinguishable from no change in risk. Haber’s data, properly
understood, do not show that the third dose of a rotavirus vaccine has any statistically
significant association with rates of intussusception. Haber therefore contradicts Mr.
Germaine’s argument that the study found “an increased risk of intussusception after
the third dose[.]” Pet.’s Mot. for Rev. at 5.
Second, Mr. Germaine emphasizes that Koch, et al., Risk of Intussusception
After Rotavirus Vaccination, 114 Deutsches Ärzteblatt Int’l 255 (2017) (ECF 21),
found the “relative risk” of intussusception after the third dose was 1.14, “which
demonstrates an increased relative risk of intussusception after the third dose[.]”
Pet.’s Mot. for Rev. at 6. Mr. Germaine is correct that a relative risk greater than 1.0
refers to an increased risk of an outcome, see Reference Manual on Scientific Evidence
627, but once more he overlooks the confidence interval: 0.75 to 1.74. Koch at 255,
259. The small increased relative risk, in other words, was statistically insignificant
— indistinguishable from no increased risk at all. That is why Koch concluded —
rightly, from a statistical perspective — that there is no increased risk of
intussusception after the third dose of a rotavirus vaccine. Id. at 260. The Special
Master, in turn, did not err in relying on that conclusion.
- 4 -

Case 1:18-vv-00800-SSS Document 70 Filed 07/29/21 Page 5 of 5
CONCLUSION
For the foregoing reasons, the motion for review is DENIED and the decision
of the Special Master is SUSTAINED.
The Clerk is directed to enter judgment accordingly.
IT IS SO ORDERED.
s/ Stephen S. Schwartz
STEPHEN S. SCHWARTZ
Judge
- 5 -