VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_23-vv-00230
Package ID: USCOURTS-cofc-1_23-vv-00230
Petitioner: B.H.B.
Filed: 2023-02-16
Decided: 2025-02-18
Vaccine: influenza
Vaccination date: 2020-09-24
Condition: type 1 narcolepsy
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
On February 16, 2023, Jennifer and Michael Barrios filed a petition on behalf of their minor child, B.H.B., alleging that influenza vaccines administered on September 24, 2020 and October 27, 2020 caused type 1 narcolepsy. Within about a month of the second vaccination, the parents observed that B.H.B.'s alertness decreased. By December 2020, B.H.B. had an episode of extreme fatigue and lethargy that led to emergency care and further evaluation.

Sleep specialist Dr. Emmanuel Mignot followed B.H.B. in 2021 and 2022. After sleep studies, he concluded that B.H.B. had classical type 1 narcolepsy and wrote that the influenza vaccines plausibly caused it. Dr. Mignot recognized that B.H.B.'s young age was unusual but not exceptional, and he relied in part on science connecting narcolepsy to Pandemrix, an adjuvanted H1N1 influenza vaccine used in Europe. He also acknowledged that studies had not shown an increased narcolepsy risk after influenza vaccines other than Pandemrix.

Chief Special Master Corcoran had previously rejected similar claims involving the non-adjuvanted influenza vaccines typically administered in the United States. He ordered petitioners to show cause and allowed them to consult an expert, but directed them to identify new scientific or medical findings rather than submit a full report. Petitioners consulted Dr. Michael Lacey, who criticized the Duffy study and argued that neurologic autoimmune phenomena can follow infections and vaccinations, but the Chief Special Master found the submission did not provide new evidence overcoming prior decisions.

On August 22, 2024, the Chief Special Master dismissed the petition, finding that petitioners had not shown that the non-adjuvanted U.S. influenza vaccine can cause narcolepsy. Judge Edward H. Meyers denied review in an opinion first issued February 18, 2025 and reissued publicly on March 11, 2025, holding that the Special Master did not abuse his discretion by relying on prior Program experience or by resolving the case without a filed expert report. No compensation was awarded.

Theory of causation field:
Minor B.H.B.; influenza vaccines September 24 and October 27, 2020; type 1 narcolepsy. DISMISSED. Alertness decreased within about one month of second dose; December 2020 extreme fatigue/lethargy; sleep studies; Dr. Emmanuel Mignot diagnosed classical type 1 narcolepsy and offered plausibility letter based largely on Pandemrix/adjuvanted H1N1 science while acknowledging no studies for other flu vaccines. Dr. Michael Lacey consulted; no new science overcame prior D'Tiole/McCollum/Kalajdzic/Dougherty line. SM Corcoran dismissed August 22, 2024; Judge Meyers denied review February 18, 2025/reissued March 11, 2025. Petition filed February 16, 2023. No award.

Public staged source text:

================================================================================
DOCUMENT 1: USCOURTS-cofc-1_23-vv-00230-0
Date issued/filed: 2025-03-11
Pages: 10
Docket text: JUDGE VACCINE UNREPORTED OPINION (PUBLIC VERSION) on 26 Judge Vaccine Order/Opinion Signed by Judge Edward H. Meyers. (dmc) Service on parties made.
--------------------------------------------------------------------------------
Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 1 of 10
In the United States Court of Federal Claims
No. 23-230V
Filed: February 18, 2025
Reissued: March 11, 20251
________________________________________
)
JENNIFER BARRIOS and MICHAEL BARRIOS, )
parents of minor child, B.H.B., )
)
Petitioner, )
)
v. )
)
SECRETARY OF HEALTH AND HUMAN )
SERVICES, )
)
Respondent. )
________________________________________ )
David P. Murphy, David P. Murphy & Associates, P.C., Greenfield, IN, for Petitioners.
Sarah C. Duncan, Vaccine/Torts Branch, Civil Division, United States Department of Justice,
Washington, D.C., with whom were Brian M. Boynton, Principal Deputy Assistant Attorney
General, C. Salvatore D’Alessio, Director, and Heather L. Pearlman, Deputy Director, for
Respondent.
OPINION AND ORDER
MEYERS, Judge.
I. Background
Jennifer and Michael Barrios had their minor child B.H.B. vaccinated with an influenza
vaccine in September and October 2020. Within a month of the second vaccination, Mrs.
Barrios began seeing B.H.B.’s alertness decreasing. ECF No. 8 ¶ 10. This continued into
December 2020. Then, B.H.B. had an episode of extreme fatigue and lethargy, resulting in a trip
to an emergency room. Id. ¶ 11. After several visits to doctors and specialists into early 2021,
including several sleep studies, sleep specialist Dr. Emmanuel Mignot, M.D., Ph.D., concluded
that B.H.B.’s symptoms were consistent with type 1 narcolepsy. ECF No. 8 ¶ 23; ECF No. 9-6
at 13–17.
1 The court issued this opinion to the parties on February 18, 2025, and, pursuant to Vaccine
Rule 18(b), gave them an opportunity to propose redactions. Because they did not propose any,
the court reissues this opinion in its entirety.

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 2 of 10
Dr. Mignot saw B.H.B. several more times in 2021 and 2022. In February 2022, after
additional sleep studies, Dr. Mignot wrote that B.H.B. had “classical narcolepsy type 1.” ECF
No. 8 ¶ 29. Dr. Mignot opined that B.H.B.’s influenza vaccines caused his narcolepsy and
prepared a letter of biological plausibility regarding the influenza vaccine B.H.B. received and
narcolepsy. ECF No. 8 ¶¶ 28–29.
In his plausibility letter, Dr. Mignot began by recounting B.H.B.’s symptoms and test
results. ECF No. 9-7 at 1. He then recognized that B.H.B.’s young age was unusual but “not
exceptional.” Id. at 2. As to a link to the influenza vaccine, Dr. Mignot pointed to an increased
risk of developing narcolepsy after taking Pandemrix, an adjuvanted influenza vaccine. Id. He
also explained that “DQ0602 positive narcolepsy cases have more T cells reactive to certain
epitopes of the 2009-2010 ‘swine flu’ H1N1 HA molecule when compared to matched controls.”
Id. That said, Dr. Mignot recognized that there were no studies showing an increase in
narcolepsy following any influenza vaccination other than Pandemrix. But he found it plausible
that the vaccine that B.H.B. got, which was not adjuvanted and was not Pandemrix, caused the
narcolepsy. Id.
Believing that the influenza vaccine caused B.H.B.’s narcolepsy, his parents brought their
claim to the Vaccine Injury Compensation Program. During an early conference, the Chief
Special Master informed the parties that he “ha[d] on several prior occasions been tasked with
determining if the flu vaccine can cause narcolepsy—and have never so found (with my
determinations to date being consistently upheld on appeal).” ECF No. 15. In these prior
opinions, the Chief Special Master had found evidence of causation lacking:
1. D’Toile v. Sec’y of Health & Human Servs., No. 15-085V, 2016 WL 7664475
(Fed. Cl. Spec. Mstr. Nov. 28, 2016), mot. for review den’d, 2017 WL 2729570
(Fed. Cl. Mar. 2, 2017), aff’d, 726 F. App’x 809 (Fed. Cir. 2018). The Chief
Special Master “considered the scientific reliability and evidentiary
persuasiveness of the theory that flu vaccines administered in the U.S. and
containing the H1N1 influenza strain can provoke an autoimmune process via
molecular mimicry, thereby producing narcolepsy’s conclusion that Flumist could
not cause narcolepsy.” ECF No. 15 at 1. He determined that it could not be
shown that the influenza vaccine at issue could cause narcolepsy and noted the
distinction between adjuvanted and non-adjuvanted vaccines. ECF No. 15 at 1.
His determination “was upheld by this court and affirmed by the Federal Circuit.”
ECF No. 15 at 1.
2. McCollum v. Sec’y of Health & Hum. Servs., No. 14-790V, 2017 WL 5386613
(Fed. Cl. Spec. Mstr. Sept. 15, 2017), mot. for review den’d, 135 Fed. Cl. 735
(2017), aff’d, 760 F. App’x 1003 (Fed. Cir. 2019). In McCollum, the Chief
Special Master concluded that causation failed because “the most reliable
literature implicated the inclusion of the adjuvant as the likely causal factor
associating H1N1-cotaining vaccines with narcolepsy, and a large-scale
epidemiologic study undermined an association involving the unadjuvanted
version.” ECF No. 15 at 2.

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 3 of 10
3. A.K. v. Sec’y of Health & Hum. Servs., No. 17-792V, 2022 WL 2678877 (Fed. Cl.
Spec. Mstr. June 17, 2022), mot. for review den’d, No. 17-792V, 2024 WL
4524777 (Fed. Cl. Oct. 27, 2022), aff’d, 2024 WL 3064398 (Fed. Cir. June 20,
2024).2 In A.K., the Chief Special Master relied on his prior holdings that the
influenza vaccines could not cause narcolepsy but only after explaining that no
new literature had been presented or identified that would cause him to reconsider
his prior conclusions that the non-adjuvanted influenza vaccines typically
administered in the United States do not cause narcolepsy.
Given his prior examination of the science, the Chief Special Master ordered Petitioners
to show cause why he should not dismiss this claim based on the same rationale—i.e. that the
Petitioner’s theory failed to preponderantly establish causation under Althen3 prong one. ECF
No. 15. But the Chief Special Master did not decide the causation issue; rather, he invited
Petitioners to consult with an expert “to identify and show new scientific or medical findings
bearing on the subject, and that would justify re-examining whether the inactivated and
unadjuvanted version of the flu vaccine could cause narcolepsy.” Id. at 2. Although the Chief
Special Master allowed Petitioners could consult with an expert, he instructed that they should
not file an expert report. Id.
The Chief Special Master held another conference with the parties in November 2023, in
which he went further in explaining what he was looking for in terms of causation evidence. He
explained4 that he understood the studies showing a connection between Pandemrix—the
adjuvanted vaccine that has been administered in Europe—and narcolepsy. But, as he addressed
in his prior decisions, the influenza vaccines utilized in the United States are non-adjuvanted. As
a result, the Chief Special Master advised that:
You need to show me that either the version that the studies show
is connected with narcolepsy is administered in the U.S.[,] or that
the child in question B.H.B. got that one[,] or there needs to [be]
some new literature or research that says adjuvanted or not, it
doesn’t matter.
ECF No. 20 at 4. The Chief Special Master also recognized that Dr. Mignot opined that it was
“plausible” that the non-adjuvanted influenza vaccine that B.H.B. got caused his narcolepsy. On
this point, the Chief Special Master emphasized:
[T]hat in the Vaccine Program the first prong of the Althen test,
whether the vaccine can cause the injury that’s alleged, plausibility
is not the standard, it’s preponderance . . . . I need preponderant
2 At the time of the conference in this case, the litigation in A.K. was ongoing and the Federal
Circuit had not yet affirmed the Chief Special Master.
3 As discussed below, Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir.
2005), sets forth the elements a petitioner must establish in a non-table claim.
4 Although there was not a court reporter, the conference was recorded, and Petitioners
transcribed portions of the conference in their response to the show cause order.

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 4 of 10
evidence[,] which means more likely than not evidence; it doesn’t
mean certainty, but it means more than plausible.
Id. at 4–5. The Chief Special Master also extended the deadline for Petitioners to respond to his
show cause order to allow them more time to consult with an expert.
Petitioners did consult an expert, Dr. Michael Lacey, to review their petition, Dr.
Mignot’s plausibility letter, and the Chief Special Master’s prior cases addressing the connection
between the influenza vaccine and narcolepsy. See id. at 7. Petitioners did not submit anything
directly from Dr. Lacey, but they did relay his opinions in their response to the show cause order.
According to Dr. Lacey, there are neurological autoimmune phenomena that have been
found following acute infections and “post vaccination reactions to H1N1, Shingles, COVID and
others.” Id. Therefore, Dr. Lacey opines that “to state that something is not possible or
attributable simply because a case report can’t be found is to draw a conclusion at one’s peril.”
Id.
Dr. Lacey next opined about two problems with reliance on the Duffy Study, which had
been addressed and found persuasive in D’Toile, McCollum, and A.K. First, he noted that it was
a large survey of data rather than patients, meaning that the Duffy Study does not mean that
isolated cases do not exist. ECF No. 20 at 8. Second, he explained that, in his view, Duffy
performed a “survey” of data rather than a true medical “study.” Id. As a “survey,” he
discounted its usefulness in determining causation. Id.
Finally, Dr. Lacey stated that because medical diagnosis requires excluding etiologies
that can be eliminated and winnowing down the list to “plausible possibilities,” it may be
impossible to find the irrefutable cause of a condition. Id. Thus, he criticized the use of the
preponderance standard because it requires the reliance on “statistical and legal criteria from a
retrospective analysis rather than medical analysis of facts.” Id.
The Chief Special Master’s review of Petitioners’ submissions led him to conclude that
Petitioners “did not otherwise offer any more recent scientific/medical publications.” ECF No.
21 at 3. Therefore, he dismissed the case based on his prior rulings:
I have repeatedly determined that the nonadjuvanted form of the
flu vaccine administered in the U.S. (and regardless of
administration form) has not been preponderantly established to
likely cause narcolepsy. See generally D’Tiole v. Sec’y of Health
& Hum. Servs., No. 15-085V, 2016 WL 7664475 (Fed. Cl. Spec.
Mstr. Nov. 28, 2016) (involving Flumist/nasal spray vaccine), mot.
for review den’d, 2017 WL 2729570 (Fed. Cl. Mar. 2, 2017), aff’d,
726 F. App’x 809 (Fed. Cir. 2018); McCollum v. Sec’y of Health &
Hum. Servs., No. 14-790V, 2017 WL 5386613 (Fed. Cl. Spec.
Mstr. Sept. 15, 2017) (involving inactivated, intramuscularly-
administered form of vaccine), mot. for review den’d, 135 Fed. Cl.
735 (2017), aff’d, 760 F. App’x 1003 (Fed. Cir. 2019). Other
special masters have reached the same conclusion. Dougherty v.

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 5 of 10
Sec’y of Health & Hum. Servs., No. 15-1333V, 2018 WL 3989519
(Fed. Cl. Spec. Mstr. July 5, 2018), aff’d, 141 Fed. Cl. 223 (2018).
And this summer, the Federal Circuit again concurred with my
reasoning, which had resulted in dismissal of a case on the papers
rather than after hearing. Kalajdzic [v. Sec’y of Health & Hum.
Servs.], [No. 2023-1321,] 2024 WL 3064398, at *2 [(Fed. Cir.
June 20, 2024)].
Id. at 5. Petitioners timely filed a motion for review in which they argue that their inability to
file an expert report deprived them of a chance to prove causation. See ECF No. 23 at 3.
II. Standard of Review
When reviewing a claim under the Vaccine Act, this court may:
(A) uphold the findings of fact and conclusions of law of the
special master and sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the
special master found to be arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law and issue its
own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in
accordance with the court’s direction.
42 U.S.C. § 300aa-12(e)(2). A key limitation of this statutory regime is that the deference with
which the court reviews the Special Masters’ decisions. This court reviews a Special Master’s
findings of fact deferentially under the “arbitrary and capricious” standard, legal questions under
the “not in accordance with law” standard, and discretionary rulings for “abuse of discretion.”
Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1358 (Fed. Cir. 2019); Munn v. Sec’y
of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). It is not this court’s role “to
second guess the Special Master[’]s fact-intensive conclusions; the standard of review is
uniquely deferential for what is essentially a judicial process.” Hodges v. Sec’y of Health &
Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993).
“An abuse of discretion may be found when (1) the court’s decision is clearly
unreasonable, arbitrary, or fanciful; (2) the decision is based on an erroneous conclusion of the
law; (3) the court’s findings are clearly erroneous; or (4) the record contains no evidence upon
which the court rationally could have based its decision.” Simmons v. Sec’y of Health & Hum.
Servs., 875 F.3d 632, 635 (Fed. Cir. 2017) (quoting Hendler v. United States, 985 F.2d 1364,
1380 (Fed. Cir. 1991)); see also Munn, 970 F.2d at 870 n.10; Burns v. Sec’y of Health & Hum.
Servs., 3 F.3d 415, 416–17 (Fed. Cir. 1993); Doe/17 v. Sec’y of Health & Hum. Servs., 84 Fed.
Cl. 691, 704–05 (2008). Reversible error is “extremely difficult to demonstrate” when the
Special Master has “considered the relevant evidence of record, drawn plausible inferences and
articulated a rational basis for the decision.” Hines v. Sec’y of Health & Hum. Servs., 940 F.2d
1518, 1528 (Fed. Cir. 1991).

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 6 of 10
III. Discussion
A. Legal Standard
Because this is a non-table claim, Petitioners must establish 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
proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health and
Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). The failure to meet just one of the three
prongs is sufficient basis for a claim’s dismissal. Dobrydnev v. Sec’y of Health & Hum. Servs.,
566 F. App’x 976, 980 (Fed. Cir. 2014).
Under Althen prong one, Petitioners must provide a “reputable medical theory”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford v. Sec’y of
Health & Hum. Servs., 451 F.3d 1352, 1355–56 (Fed. Cir. 2006) (citations omitted). To satisfy
this prong, a petitioner’s theory must be based on a “sound and reliable medical or scientific
explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994).
Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature, epidemiological
studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu
v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano v.
Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325–26 (Fed. Cir. 2006)). Special Masters,
despite their expertise, are not empowered by statute to conclusively resolve what are essentially
thorny scientific and medical questions, and thus scientific evidence offered to establish Althen
prong one is viewed “not through the lens of the laboratorian, but instead from the vantage point
of the Vaccine Act’s preponderant evidence standard.” Id. at 1380.
B. The Chief Special Master’s consideration of his prior decisions and those of
other Special Masters was not improper.
Petitioners’ claim challenges the fairness of the process employed by the Chief Special
Master. The foundation of that process was his consideration of the prior cases that brought the
same causation theory as Petitioners—that the influenza vaccine caused narcolepsy. Althen
prong one requires Petitioners to put forward “a medical theory causally connecting the
vaccination and the injury.” Althen, 418 F.3d at 1278. The Chief Special Master explained that
he had “repeatedly determined that the nonadjuvanted form of the flu vaccine administered in the
U.S. (and regardless of administration form) has not been preponderantly established to likely
cause narcolepsy.” ECF No. 21 at 4–5. Thus, the first question is whether the Chief Special
Master’s reliance on his prior decisions considering whether the influenza vaccine could be
preponderantly shown to cause narcolepsy was an abuse of discretion or contrary to law.
As an initial matter, the Chief Special Master recognized that his prior decisions were
“not binding on the outcome” of Petitioners’ claim. ECF No. 21 at 5 (citing Hanlon v. Sec’y of
Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998) (“Special masters are neither bound by their
own decisions nor by cases from the Court of Federal Claims, except, of course, in the same case
on remand.”)). But the fact that the Chief Special Master was not bound by his prior decisions
does not mean he was required to ignore them—Special Masters are not required to ignore

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 7 of 10
precedent and relitigate causation theories that have already been litigated repeatedly. The
Special Masters have “the unenviable job of sorting through these painful cases and, based upon
their accumulated expertise in the field, judging the merits of the individual claims.” Deribeaux
v. Sec’y of Health & Hum. Servs., 717 F.3d 1363, 1366 (Fed. Cir. 2013) (emphasis added)
(quoting Hodges, 9 F.3d at 961). Indeed, “nothing in prior Vaccine Program case law ‘requires
the Special Master to ignore probative epidemiological evidence that undermines petitioner’s
theory.’” Dougherty v. Sec’y of Health & Hum. Servs., 141 Fed. Cl. 223, 230 (2018).
Again, the Chief Special Master considered three prior decisions of his finding that the
scientific evidence underlying Petitioners’ claim failed to establish causation under Althen prong
one. He found them “persuasive guidance” that “stand as significant obstacles to the claim that
the flu vaccine can cause narcolepsy.” ECF No. 21 at 5. Nor was the Chief Special Master
alone. He also recognized that another Special Master had also considered and rejected the
theory that the nonadjuvanted influenza vaccine typically administered in the United States could
cause narcolepsy under Althen prong one. Id. (citing Dougherty v. Sec’y of Health & Hum.
Servs., No. 15-1333V, 2018 WL 3989519 (Fed. Cl. Spec. Mstr. July 5, 2018), aff’d, 141 Fed. Cl.
223 (2018)). In Dougherty, a Special Master relied upon recent decisions denying claims for
lack of causation, and this court affirmed because the Special Master “reasonably explained why
Petitioner’s arguments in this case failed to establish any persuasive differences from those
cases.” Dougherty, 141 Fed. Cl. at 229–30. Petitioners have not identified any Vaccine Act
decisions that have reached a contrary conclusion.
Nor did the Chief Special Master spring his reliance on prior cases on the parties without
giving them a clear understanding of how he intended to utilize the prior cases and what
evidence Petitioners would need to provide to overcome the prior decisions. In one of his
earliest actions in this case, the Chief Special Master issued his show cause order in which he
explained that he had considered the causal link between the influenza vaccine and narcolepsy in
multiple prior cases and never found causation. ECF No. 15 at 1–2. He did not rule that
Petitioners could not establish causation, but that they would need to come forward with “new
scientific or medical findings bearing on the subject” that would justify reconsidering causation.
Id. at 2.
Then, during a status conference a few months later, the Chief Special Master explained
his prior decisions further. He explained that the science presented to date indicated by
preponderant evidence that it was the inclusion of the adjuvant in Pandemrix that created the
causal link for narcolepsy, that there was no basis to extend that science to the nonadjuvanted
vaccines administered in the United States, and that:
You need to show me that either the version that the studies show
is connected with narcolepsy is administered in the U.S.[,] or that
the child in question B.H.B. got that one[,] or there needs to [be]
some new literature or research that says adjuvanted or not, it
doesn’t matter.
ECF No. 20 at 4. And after further explaining the type of evidence that Petitioners would need
to bring forward, the Chief Special Master extended their deadline to file their response to the
show cause order.

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 8 of 10
In the end, the Chief Special Master applied the appropriate legal standard and did not
abuse his discretion in considering prior decisions regarding causation under Althen prong one.
Indeed, his reliance on epidemiological evidence about whether nonadjuvanted influenza
vaccines can cause narcolepsy is precisely the kind of experience and expertise that Special
Masters bring to the table. Dougherty, 141 Fed. Cl. at 230; see also Deribeaux, 717 F.3d at
1366.
C. The Chief Special Master did not abuse his discretion or err as a matter of
law by dismissing this case without allowing Petitioners to file an expert report.
Petitioners next complain that the Chief Special Master erred by not allowing them to file
an expert report. ECF No. 23 at 2–3. When he issued his show cause order, the Chief Special
Master explained his prior consideration of Petitioners’ theory and that the studies on the subject
did not support their theory. And, again, the Chief Special Master did call on Petitioners to
identify any new studies or medical findings that would warrant his reconsideration of their
causation theory. Recall also that he explained in his order and in the status conference with the
parties what type of evidence that he was looking for. He instructed that “Petitioners may
consult with an expert, although they should not file an expert report at this time.” ECF No. 15
at 2. It is this instruction that Petitioners complain about here, arguing “that they have not had
‘due opportunity’ to present an expert opinion on the issue of causation as required by Althen
Prong One.” ECF No. 23 at 3.
A Special Master has the discretion to dismiss cases on the written record without
allowing the petitioners to submit expert testimony if the Special Master determines “that the
record is comprehensive and fully developed before ruling on the record.” See Bello v. Sec’y of
Health & Hum. Servs., 158 Fed. Cl. 734, 742–44, 748–49 (2022) (internal quotation marks
omitted) (quoting Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020)). In Bello, the court affirmed the Chief Special Master’s dismissal of a case without
allowing an expert report because the court found that his “factual findings were reasonable and
supported by the record before him,” and “[h]is decision not to . . . consider expert testimony
represents a reasonable exercise of his discretion . . . and did not deprive Petitioners of a full and
fair opportunity to have their claims heard.” Bello, 158 Fed. Cl. at 749.
The Chief Special Master did not abuse his discretion by deciding this case without
hearing expert testimony. He based his decision on the studies of the type of influenza vaccine at
issue and provided several opportunities for Petitioners to come forward with any evidence they
could that would warrant reconsidering those studies. Indeed, the Chief Special Master gave
clear direction on the kind of evidence that he would require to let Petitioners’ claim go forward.
ECF No. 20 at 4.
Petitioners, however, “offered no new/different scientific or medical findings that would
increase the likelihood that Petitioners can meet their burden of establishing that the flu vaccine
‘can cause’ narcolepsy.” ECF No 21 at 5. If the Chief Special Master had simply dismissed the
case without any allowance for Petitioners to put forward new evidence, Petitioners could more
persuasively contend the record was insufficient. But that was not the case here. Again, the

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 9 of 10
Chief Special Master explained his familiarity with the studies addressing Petitioners’ theory and
instructed them to identify any new scientific or medical study or factual distinction that would
warrant reconsideration of his prior decision that the nonadjuvanted influenza vaccine could not
cause narcolepsy.
Because the Chief Special Master had a sufficient record to determine causation, which
was confirmed by the Petitioners’ inability to identify new support for their theory, he did not
abuse his discretion by deciding this case without hearing expert testimony.
D. Petitioners fail to establish the Chief Special Master’s treatment of their
response to the show cause order was an abuse of discretion.
Finally, Petitioners contend they “obeyed the Order of the [Chief Special Master] and
submitted only the summary of Dr. Michael Lacey as to the evidence already contained in the
[r]ecord.” ECF No. 23 at 3. This complaint is difficult to reconcile with the record in this case.
As detailed above, the Chief Special Master issued his show cause order in which he identified
the specific evidence that would be necessary for this case to go forward—an expert would need
“to identify and show new scientific or medical findings bearing on the subject, and that would
justify re-examining whether the inactivated and unadjuvanted version of the flu vaccine could
cause narcolepsy.” ECF No. 15 at 2. And during the November 7, 2023 status conference, the
Chief Special Master went further:
You need to show me that either the version that the studies show
is connected with narcolepsy is administered in the U.S.[,] or that
the child in question B.H.B. got that one[,] or there needs to [be]
some new literature or research that says adjuvanted or not, it
doesn’t matter.
ECF No. 20 at 4. There is nothing in either direction that indicates Petitioners would be limited
to only what was in the record. It is also notable what Petitioners are not arguing. They do not
assert that Dr. Lacey would have presented a report discussing new scientific or medical
findings.5 Rather, they contend that his disagreements with the evidence the Chief Special
5 To the extent that Dr. Lacey’s disagreement with the Chief Special Master’s prior decisions is
based on the Chief Special Master requiring petitioners to establish causation by the
preponderance of the evidence rather than plausibility, ECF No. 20 at 8–9, that contention is
misplaced. First, the evidentiary standard for claims under the Vaccine Program presents a
question of law on which expert testimony is not proper. Second, and more importantly, the
Federal Circuit has consistently and uniformly rejected the argument that plausibility is sufficient
and held that petitioners must establish causation by a preponderance of the evidence. See
LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[S]imply
identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet [his] burden of
proof. Instead, the statutory standard of preponderance of the evidence requires a petitioner to
demonstrate that the vaccine more likely than not caused the condition alleged.” (internal citation
omitted) ((citing Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir.
2010))).

Case 1:23-vv-00230-EHM Document 28 Filed 03/11/25 Page 10 of 10
Master relied upon in his prior decisions justify reconsidering the prior decisions. ECF No. 20 at
9. The Chief Special Master did not abuse his discretion rejecting this contention.
IV. Conclusion
Because the Chief Special Master applied the proper legal standard and reasonably relied
on his prior experience with Petitioners’ causation theory, the court denies the Petitioners’
motion for review, ECF No. 22, and sustains the Chief Special Master’s decision.
The Clerk’s Office is directed to enter judgement accordingly.
It is so ORDERED.
s/ Edward H. Meyers
Edward H. Meyers
Judge

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_23-vv-00230-2
Date issued/filed: 2026-01-05
Pages: 6
Docket text: PUBLIC DECISION (Originally filed: 08/22/2024) regarding 21 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made.
--------------------------------------------------------------------------------
Case 1:23-vv-00230-EHM Document 34 Filed 01/05/26 Page 1 of 6
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 23-230V
* * * * * * * * * * * * * * * * * * * * * * * * *
*
JENNIFER BARRIOS and MICHAEL, * Chief Special Master Corcoran
BARRIOS, parents of minor child, B.H.B., *
*
Petitioners, * Filed: August 22, 2024
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
David P. Murphy, Greenfield, IN, for Petitioners.
Sarah C. Duncan, U.S. Dep’t of Justice, Washington, DC, for Respondent.
DECISION DISMISSING PETITION1
On February 16, 2023, Jennifer and Michael Barrios filed a petition on behalf of their minor
child, B.H.B., seeking compensation under the National Vaccine Injury Compensation Program
(the “Vaccine Program”).2 Petitioners allege that B.H.B. developed type 1 narcolepsy after receipt
of two doses of the influenza (“flu”) vaccine on September 24, 2020, and October 27, 2020,
respectively. Petition at 1–3 (ECF No. 1).
At a status conference held on July 27, 2023, I informed the parties that I had on several
prior occasions ruled against claimants alleging narcolepsy as a flu vaccine injury, and that my
determinations had been upheld on appeal. See generally Order, dated July 28, 2023 (ECF No. 15)
1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its present form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”).
Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).
1

Case 1:23-vv-00230-EHM Document 34 Filed 01/05/26 Page 2 of 6
(the “Order”). I have thus repeatedly considered whether (under the preponderant legal standard
utilized by the test set by the Federal Circuit in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005)) the flu vaccine “can cause” narcolepsy, but have determined the
theory to be scientifically unreliable (even if some elements of proof offered in favor of the theory
are credible)—and the analysis I have employed in reaching that conclusion has been affirmed.
I therefore ordered Petitioners to show cause why this claim should not be dismissed. In so
doing, I encouraged them to identify what new scientific or medical findings bearing on the subject
should reasonably be taken into account in determining whether the present claim was more likely
to succeed than prior claims involving what appeared to be the same rejected theory. Order at 2. If
Petitioners were able to marshal evidence not previously considered, but which filled in some of
the evidentiary “holes” that had prevented me in the past from finding the causation theory
preponderantly established, they might provide grounds for another look at the issue. (Although
Petitioners were given the opportunity to consult with an expert in their attempt to identify any
new scientific or medical findings, my Order specifically directed Petitioners to not file an expert
report at that time. Id.)
In response, Petitioners filed a brief on January 4, 2024. Brief, dated Jan. 4, 2024 (ECF No.
20) (“Br.”). In it, they note that they had engaged Michael Lacey, M.D., who reviewed their
amended petition, the written “Letter of Plausibility” authored by Dr. Emmanuel Mignot,3 as well
as the three Vaccine Program decisions (referenced in my Order to Show Cause) discussing the
absence of preponderant evidence that the non-adjuvanted version of the flu vaccine routinely
administered to children in the United States can cause type 1 narcolepsy. Br. at 7. Dr. Lacey did
not provide his own written statement on the matter, but instead expressed his overall opinions
which were then summarized by Petitioners’ counsel in their responsive brief.
Dr. Lacey stated that “[i]t is a fact that [n]eurological autoimmune phenomenon of all sorts
have been observed following [a] myriad [of] viral conditions—including acute infections of
influenza . . .” Br. at 7. He then appeared to briefly discuss the pitfalls of a study I have discussed
in detail in prior decisions, Duffy4—noting that the study’s “conclusions are based on a large
survey of data, not a survey of all patients” and thus “ignores the fact that isolated cases of rare
phenomenon often exist (and are not reported), . . ..” Id. at 8. Dr. Lacey further opined that Duffy
“is actually a retrospective analysis of data collected without regard to controls and therefore is
more properly referred to as a ‘Survey’ of a body of data,” meaning that it lacks definitiveness. Id.
3 Dr. Mignot, one of B.H.B.’s treating physicians, had earlier in the case offered a brief written statement regarding
the medical plausibility for a vaccination-triggering cause of type 1 narcolepsy. See generally Ex. 7 (ECF No. 9-7)
(“Letter”).
4 Dr. Lacey did not provide a citation to the Duffy Study, but a discussion of its relevance to this type of claim can be
found in McCollum v. Sec’y of Health & Hum. Servs., No. 14-709V, 2017 WL 5386613, at *17–18 (Fed. Cl. Spec.
Mstr. Sept. 15, 2017), mot. for review den’d, 135 Fed. Cl. 735 (2017), aff’d, 760 Fed. Appx. 1003 (Fed. Cir. 2019).
2

Case 1:23-vv-00230-EHM Document 34 Filed 01/05/26 Page 3 of 6
Petitioners also maintain that the relevant evidentiary standard for establishing the “can
cause” Althen prong has been met, based on Dr. Lacey’s review of the relevant materials and Dr.
Mignot’s opinions. Br. at 8–9. Petitioners argue they can show that B.H.B.’s onset of narcolepsy
symptoms occurred less than thirty days post-vaccination, and emphasize the fact that B.H.B.
carries a certain genetic component common to the majority of individuals suffering from
narcolepsy. Id. at 9. Accordingly, Petitioners contend Dr. Lacey’s comments and opinions offer
the evidence previously missing from the earlier cases I have decided. Id. Petitioners did not
otherwise offer any more recent scientific/medical publications, however.
ANALYSIS
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).
There is no Table claim involving narcolepsy as the injury, and thus Petitioners may only advance
a causation-in-fact claim.
Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof.
Section 13(1)(a). That is, a petitioner must offer evidence that leads the “trier of fact to believe
that the existence of a fact is more probable than its nonexistence before [he] may find in favor of
the party who has the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at
1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture
or speculation is insufficient under a preponderance standard). Proof of medical certainty is not
required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In
particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the
injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321
(quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999));
Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may
not receive a Vaccine Program award based solely on his assertions; rather, the petition must be
supported by either medical records or by the opinion of a competent physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in the Federal Circuit’s decision in Althen, 418 F.3d at 1278: “(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 proximate temporal relationship
3

Case 1:23-vv-00230-EHM Document 34 Filed 01/05/26 Page 4 of 6
between vaccination and injury.” The failure to meet just one of the three prongs is sufficient basis
for a claim’s dismissal. Dobrydnev v. Sec’y of Health & Hum. Servs., 566 Fed. Appx. 976, 980
(Fed. Cir. 2014).
Under Althen prong one, petitioners must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at
1355–56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound
and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or
scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.
Cl. at 245 (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis
in original)).
In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theory’s scientific or medical plausibility. See Kalajdzic v. Sec’y of Health &
Hum. Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for
a less than preponderance standard” deemed “plainly inconsistent with our precedent” (citing
Moberly, 592 F.3d at 1322)); Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359
(Fed. Cir. 2019); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4
(Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four decades”), aff’d,
2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). And petitioners always have the
ultimate burden of establishing their overall Vaccine Act claim with preponderant evidence. W.C.
v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell
v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s
overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard).
As noted above (and as I specifically informed the parties in issuing my show cause order),
I have repeatedly determined that the nonadjuvanted form of the flu vaccine administered in the
U.S. (and regardless of administration form) has not been preponderantly established to likely
4

Case 1:23-vv-00230-EHM Document 34 Filed 01/05/26 Page 5 of 6
cause narcolepsy. See generally D’Tiole v. Sec’y of Health & Hum. Servs., No. 15-085V, 2016
WL 7664475 (Fed. Cl. Spec. Mstr. Nov. 28, 2016) (involving Flumist/nasal spray vaccine), mot.
for review den’d, 2017 WL 2729570 (Fed. Cl. Mar. 2, 2017), aff’d, 726 F. App’x 809 (Fed. Cir.
2018); McCollum v. Sec’y of Health & Hum. Servs., No. 14-790V, 2017 WL 5386613 (Fed. Cl.
Spec. Mstr. Sept. 15, 2017) (involving inactivated, intramuscularly-administered form of vaccine),
mot. for review den’d, 135 Fed. Cl. 735 (2017), aff’d, 760 F. App’x 1003 (Fed. Cir. 2019). Other
special masters have reached the same conclusion. Dougherty v. Sec’y of Health & Hum. Servs.,
No. 15-1333V, 2018 WL 3989519 (Fed. Cl. Spec. Mstr. July 5, 2018), aff’d, 141 Fed. Cl. 223
(2018). And this summer, the Federal Circuit again concurred with my reasoning, which had
resulted in dismissal of a case on the papers rather than after hearing. Kalajdzic, 2024 WL
3064398, at *2.
These determinations are of course not binding on the outcome herein. Hanlon v. Sec’y of
Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). But they are persuasive guidance, and they
stand as significant obstacles to the claim that the flu vaccine can cause narcolepsy. What is left is
the possibility that a theory comparable to what is alleged herein could work—but to turn that
possibility into a preponderant showing, a claimant would need to marshal arguments and proof
different from what has been considered so many times before.
Here, and despite due opportunity,5 Petitioners have offered no new/different scientific or
medical findings that would increase the likelihood that Petitioners can meet their burden of
establishing that the flu vaccine “can cause” narcolepsy. Rather, Drs. Lacey and Mignot cite to
studies6 that have previously been discussed in other decisions where the same/similar theory has
been proposed. See, e.g., McCollum, 760 F. App’x 1003, 1007; D’Tiole, 2016 WL 7664475, at
*20–23, aff’d, 726 F. App’x 809 (Fed. Cir. 2018); Kalajdzic, 2024 WL 3064398, at *3. Nor have
Petitioners shown in their briefing that prior determinations that causation was not preponderantly
established were in error, or otherwise that independent evidence offered in this case is more
supportive of the causal theory. Submission of a “new” expert report from a “new” expert is not
enough, especially if that report simply repeats arguments that have been found wanting before.
I do not question Petitioners’ good-faith belief in their claim, and I credit their desire to
protect and care for B.H.B. But the context of this case mandates dismissal, since it merely offers
5 I initially issued my Show Cause Order in late July 2023, and Petitioners responded to it in January 2024, giving
them ample time to locate evidence supportive of the theory. I also permitted them to consult with an expert in so
doing, and they offered Dr. Lacey’s opinion. Order at 2.
6 Dr. Mignot’s Letter does reference two items not previously offered in my prior cases. See F. Han et al., Decreased
Incidence of Childhood Narcolepsy 2 Years after the 2009 H1N1 Winter Flu Pandemic, 73 Annals Neurology 560
(2013); H. Wasling et al., Quality of Life and Procrastination in Post-H1N1 Narcolepsy, Sporadic Narcolepsy and
Idiopathic Hypersomnia, A Swedish Cross-Sectional Study, 76 Sleep Med. 104 (2020). But he provides no explanation
for or description of these items that would suggest they advance any new propositions different from what I have so
frequently considered in other cases, and they have not been filed herein.
5

Case 1:23-vv-00230-EHM Document 34 Filed 01/05/26 Page 6 of 6
a theory not deemed preponderantly persuasive in prior circumstances—and a theory that I have
carefully considered in those prior decisions. The Program operates under a crushing case load,
and claims that repeat reasonably-rejected causation theories should not be allowed to go to hearing
simply because a claimant hopes for a different outcome. Special masters rely on their expertise
with prior determinations when faced with new cases—and just as they should seek settlement of
claims they expect (based on their experience) are likely to succeed, they should dismiss cases that
their hard-earned experience tells them are unlikely to succeed.
Accordingly, the Petition is dismissed. In the absence of a motion for review filed pursuant
to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with
the terms of this Decision.7
IT IS SO ORDERED.
/s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
7 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.
6