VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_24-vv-01168
Package ID: USCOURTS-cofc-1_24-vv-01168
Petitioner: M.V.
Filed: 2024-07-31
Decided: 2025-08-25
Vaccine: MCV4 and Tdap
Vaccination date: 2021-08-04
Condition: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Joseph Virissimo, on behalf of his minor child M.V., filed a petition on July 31, 2024, alleging that the meningococcal conjugate (MCV4) and tetanus, diphtheria, and acellular pertussis (Tdap) vaccines M.V. received on August 4, 2021, caused her to suffer from Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Petitioner submitted medical records and an expert report from immunologist Dr. Jeffrey Davidson. Dr. Davidson opined that the vaccines caused M.V.'s SJS/TEN, citing case reports, case series, systemic reviews, and a VAERS analysis. He noted M.V. had no other vaccines, drugs, or infections in the months prior to symptom onset, which occurred on August 17, 2021, thirteen days post-vaccination. Dr. Davidson addressed potential confounding factors, stating M.V.'s positive antinuclear antibody was not indicative of autoimmune disease given other negative rheumatology panel results, and that a note of M.V. being "slightly sick 1-2 weeks before" vaccination was after her vaccination and no symptoms were reported on the day of vaccination. Respondent argued that Dr. Davidson failed to present a reliable medical theory causally linking the vaccinations to the SJS/TEN or establish a logical sequence of cause and effect. Respondent noted that much of Dr. Davidson's literature involved unrelated vaccines and argued he had not presented reliable scientific or medical evidence for an appropriate timeframe. Respondent also highlighted references in the medical records to M.V. experiencing a viral illness prior to SJS/TEN onset and multiple positive tests during hospitalization, which Dr. Davidson did not discuss. Respondent further contended that temporal relationship or elimination of other causes alone was insufficient. Respondent submitted an expert report from immunologist Dr. Emanual Maverakis, who opined that the vaccinations were not connected to M.V.'s SJS/TEN. Dr. Maverakis explained that SJS/TEN is mediated by cytotoxic CD8+ T cells, and that there is no mechanistic link between SJS/TEN pathophysiology and the immune response induced by vaccination. He disputed any association between SJS/TEN and vaccination, citing studies suggesting antigen quantity is critical and arguing M.V.'s antigenic dose was insufficient. Dr. Maverakis opined M.V.'s condition was idiopathic or caused by a pre-vaccination infection. After respondent filed his expert report, petitioner moved to dismiss his own petition. Special Master Christian J. Moran construed this as a motion for involuntary dismissal. The Special Master found that petitioner had not presented a medical theory to explain how the MCV4 and/or Tdap vaccines could cause SJS/TEN. The Special Master noted that case reports and VAERS analyses, as presented by Dr. Davidson, often have limited usefulness in litigation for establishing causation. Therefore, the Special Master concluded that petitioner had not met the burden of proof under Althen v. Sec’y of Health & Hum. Servs. The case was dismissed with prejudice for insufficient proof.

Theory of causation field:
Petitioner Joseph Virissimo, on behalf of M.V., alleged that MCV4 and Tdap vaccines administered on August 4, 2021, caused SJS/TEN, with symptom onset on August 17, 2021. Petitioner's expert, Dr. Jeffrey Davidson, opined that the vaccines caused the injury, citing case reports, case series, systemic reviews, and VAERS data, and noting the absence of other triggers and the temporal proximity. Respondent's expert, Dr. Emanual Maverakis, opined there was no mechanistic link between vaccination and SJS/TEN, that the antigenic dose was insufficient, and that the condition was likely idiopathic or caused by a pre-vaccination infection. The Special Master, Christian J. Moran, found that petitioner failed to present a reliable medical theory causally connecting the vaccines to SJS/TEN, as required by Althen v. Sec’y of Health & Hum. Servs., noting that case reports and VAERS analyses alone are insufficient for establishing causation in litigation. The case was dismissed with prejudice for insufficient proof. Attorneys for petitioner were Michael H Coggeshall, Gillock & Coggeshall. Attorney for respondent was Parisa Tabassian. Decision date: August 25, 2025.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_24-vv-01168-0
Date issued/filed: 2025-08-25
Pages: 5
Docket text: PUBLIC DECISION (Originally filed: 07/30/2025 ) regarding 38 DECISION of Special Master Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
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Case 1:24-vv-01168-UNJ Document 39 Filed 08/25/25 Page 1 of 5
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
JOSEPH VIRISSIMO, * No. 24-1168V
parent, on behalf of M.V., *
*
Petitioner, *
* Special Master Christian J. Moran
v. *
* Filed: July 30, 2025
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Michael H Coggeshall, Gillock & Coggeshall, Las Vegas, NV, for petitioner;
Parisa Tabassian, United States Dep’t of Justice, Washington, D.C., for respondent.
UNPUBLISHED DECISION DENYING COMPENSATION1
Petitioner, Joseph Virissimo, filed a petition for compensation on July 31,
2025, alleging that the meningococcal conjugate (“MCV4”) vaccine and tetanus,
diphtheria, and acellular pertussis (“Tdap”) vaccine his child M.V. received on
August 4, 2021, caused M.V. to suffer from Stevens-Johnson Syndrome (“SJS”)
and Toxic Epidermal Necrolysis (“TEN”). On July 22, 2025, Mr. Virissimo filed a
motion for a decision dismissing his petition.
1 Because this Decision contains a reasoned explanation for the action taken in this case, it must
be made publicly accessible and will be posted on the United States Court of Federal Claims’
website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance
with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and
Promotion of Electronic Government Services). This means the Decision will be available to
anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14
days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. Any changes will appear in the document posted
on the website.
1

Case 1:24-vv-01168-UNJ Document 39 Filed 08/25/25 Page 2 of 5
I. Procedural History
Mr. Virissimo filed his petition on July 31, 2024, alleging that the MCV4
and Tdap vaccines his child M.V. received on August 4, 2021, caused M.V. to
suffer from SJS and TEN. With the petition, Mr. Virissimo filed several medical
records, as well as an expert report from an immunologist, Dr. Jeffrey Davidson.
Exhibit 10.
Dr. Davidson opined that vaccinations do, in rare instances, cause SJS/TEN,
and that the vaccines M.V. received were the cause of her SJS/TEN. Exhibit 10 at
2-3. Dr. Davidson referred to case reports, case series, systemic reviews, and a
VAERS analysis regarding SJS/TEN following vaccination. Id. at 3-7. He noted
that M.V. had no other vaccines, drugs, or infections in the months prior to the
onset of her SJS/TEN. Id. at 8. He further opined that the timing of her onset—
August 17, 2021, which was 13 days post-vaccination—was within the range of
reported onsets for vaccine-induced SJS/TEN in the Ball and Su papers, which
examined VAERS reports. Id. at 9.
Dr. Davidson addressed “potentially confounding facts” in his report.
Exhibit 10 at 10. He acknowledged that M.V. had a positive antinuclear antibody
but stated that this does not necessarily indicate an autoimmune disease, as it can
occur in the relatives of people with autoimmune diseases. Moreover, “the
substantiating rheumatology panel show[ed] anti-DS antibody [and] every other
autoimmune test to be negative,” which Dr. Davidson stated, “essentially rules out
an underlying immune or autoimmune disease.” Id. (emphasis in original). Dr.
Davidson also noted a single hospital note from August 26, 2021, that M.V. “was
slightly sick 1-2 weeks before,” but stated that this was after her vaccinations and
that no symptoms were reported to the pediatrician on the day of vaccination. Id.
In sum, Dr. Davidson based his opinion that the vaccines caused M.V.’s
SJS/TEN on the lack of alternative triggers such as acute illness or medications;
the onset of symptoms within the reported interval after vaccination; and the
existence of studies and reports documenting SJS/TEN rarely arising after
vaccination. Exhibit 10 at 11.
The case was reassigned to the undersigned on December 10, 2024.
Respondent was ordered to file his Rule 4(c) Report and a responsive expert report.
Order, issued Jan. 3, 2025. Respondent filed his Rule 4(c) Report on March 20,
2

Case 1:24-vv-01168-UNJ Document 39 Filed 08/25/25 Page 3 of 5
2025, arguing against compensation. Respondent argued that Dr. Davidson had
not presented a reliable medical theory causally linking M.V.’s vaccinations to her
SJS/TEN, nor established a logical sequence of cause and effect showing that they
were the actual reason for her alleged injury. Resp’t’s Rep. at 14. Respondent
noted that the “vast majority” of the literature relied upon by Dr. Davidson
discussed unrelated vaccines, and argued that he had not presented reliable
scientific or medical evidence establishing an appropriate timeframe. Id. at 15.
Respondent also highlighted several references in the medical records to M.V.
experiencing a viral illness in the weeks leading up to the onset of her SJS/TEN, as
well as multiple positive tests during her hospitalization between August 19 and
September 13, 2021, which were not discussed by Dr. Davidson. Id. at 14.
Respondent further contended that, regardless of whether M.V. had any
infections, a mere proximate temporal relationship or the elimination of other
potential causes, without more, cannot meet petitioner’s burden of showing actual
causation. Resp’t’s Rep. at 14-15. Respondent acknowledged that M.V.’s
dermatologist commented that her SJS was “possibly” related to one of the
vaccines, but she did not disclose the basis of this opinion or how she ruled out the
infections as alternative causes. Id. at 15.
On April 23, 2025, respondent filed an expert report from an immunologist,
Dr. Emanual Maverakis. Exhibit A (corrected).2 Dr. Maverakis opined that the
vaccinations M.V. received did not have any connection to her development of
SJS/TEN. Id. at 5. He explained that SJS/TEN is mediated by cytotoxic CD8+ T
cells, and that CD8+ T cell responses are undetectable in the majority of
vaccinated individuals; therefore, “there is no mechanistic link between the
pathophysiology of SJS/TEN and the immune response induced by vaccination.”
Id. at 5-6. Dr. Maverakis further disputed that there is any association between
SJS/TEN and vaccination, and commented on the low relative risk. Id. at 6-7.
Dr. Maverakis described the studies of Dr. Kirsti Kauppinen which “strongly
suggest that the quantity of antigen is a critical determinant in the development of
SJS/TEN,” and argued that the antigenic dose M.V. received “would have been
insufficient to trigger such a severe T cell-mediated reaction.” Exhibit A at 7-8.
Dr. Maverakis further explained that SJS/TEN can be idiopathic, and opined that
M.V.’s SJS/TEN was idiopathic with an unknown cause, or caused by a pre-
vaccination infection. Id. at 8-11.
2 Respondent filed a corrected version of Exhibit A to clarify a statement in the report. See Order, issued May 21,
2025. The corrected exhibit was filed as ECF No. 35.
3

Case 1:24-vv-01168-UNJ Document 39 Filed 08/25/25 Page 4 of 5
Finally, Dr. Maverakis responded directly to several points in Dr.
Davidson’s report. He again concluded that there “is no reputable, reliable medical
theory showing that vaccines can cause SJS/TEN,” and opined that M.V. had been
ill prior to vaccination, and that her SJS/TEN was more likely idiopathic with an
unknown cause or caused by an infection. Exhibit A at 11-13.
Mr. Virissimo was given the opportunity to file a supplemental report in
response to Dr. Maverakis’s report. Order, issued June 9, 2025. Instead of filing a
report, Mr. Virissimo moved to have his case dismissed.
II. Analysis
To receive compensation under the National Vaccine Injury Compensation
Program (“Program”), a petitioner must prove either 1) that the vaccinee suffered a
“Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations, or 2) that the vaccinee suffered an injury
that was actually caused by a vaccine. See §§ 300aa-13(a)(1)(A) and 300aa-
11(c)(1). Under the Act, a petitioner may not be given a Program award based
solely on the petitioner’s claims alone. Rather, the petition must be supported by
either medical records or by the opinion of a competent physician. § 300aa-
13(a)(1).
In this case, Mr. Virissimo filed medical records and an expert report in
support of his claim. Nevertheless, Mr. Virissimo wishes to have his claim
dismissed and judgment entered against him. Given Mr. Virissimo’s clear intent
that a judgment issue in this case, the undersigned will construe this as a motion
filed pursuant to 42 U.S.C. § 300aa-21(b) (regarding involuntary dismissal).
To conform to § 12(d)(3), a decision must “include findings of fact and
conclusions of law.” To conform to section 12(d)(3), a decision must “include
findings of fact and conclusions of law.” For causation-in-fact cases, the Federal
Circuit has defined elements of a petitioner’s claim. Petitioners bear a burden to
show by a preponderance of the evidence that the vaccination brought about their
injury by providing:
(1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and
(3) a showing of a proximate temporal relationship between vaccination and
injury.
4

Case 1:24-vv-01168-UNJ Document 39 Filed 08/25/25 Page 5 of 5
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
Mr. Virissimo has not presented a medical theory to explain how a MCV4
and/or Tdap vaccine could cause SJS/TEN. Although Dr. Davidson’s report
summarizes case reports, case series, and analyses of VAERS data, in the context
of litigation, this evidence often does not receive much consideration as evidence
of causation. In general, case reports provide little, if any, information helpful to
determining causation because they present only a temporal sequence of events in
which the vaccination preceded an adverse health event. See K.O. v. Sec'y of
Health & Hum. Servs., No. 13-472V, 2016 WL 7634491, at *11-12 (Fed. Cl. Spec.
Mstr. July 7, 2016) (discussing appellate precedent on case reports). Typically,
analyses of VAERS reports have limited usefulness because in part the researchers
are not aware of how many doses of a vaccine have been administered. See Flores
v. Sec'y of Health & Hum. Servs., No. 10-489V, 2013 WL 5587390, at *12-13
(Fed. Cl. Spec. Mstr. Sep. 12, 2013) (“the VAERS system does not provide
information as to the ‘background rate’ of a certain condition in a certain
population”), mot. for rev. denied, 115 Fed. Cl. 157, 164 (2014), aff'd without op,
586 Fed. App'x 588 (Fed. Cir. 2014); Werderitsh v. Sec'y of Health & Hum.
Servs., No. 99-319V, 2005 WL 3320041, at *15 (Fed. Cl. Spec. Mstr. Nov. 10,
2005) (denying motion for discovery for VAERS reports because, in part,
petitioner did not have access to denominator data). Thus, Mr. Virissimo has not
met his burden under Althen. See Puckett v. Sec'y of Health & Hum. Servs., No.
21-1125V, 2024 WL 3160589, at *3-5 (Fed. Cl. June 3, 2024).
Thus, this case is DISMISSED WITH PREJUDICE for insufficient
proof. The Clerk shall enter judgment accordingly. See Vaccine Rule 21(b).
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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