BARRIOS v. SECRETARY OF HEALTH AND HUMAN SERVICES

CourtUnited States Court of Federal Claims
DecidedMarch 11, 2025
Docket23-230
StatusUnpublished

This text of BARRIOS v. SECRETARY OF HEALTH AND HUMAN SERVICES (BARRIOS v. SECRETARY OF HEALTH AND HUMAN SERVICES) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
BARRIOS v. SECRETARY OF HEALTH AND HUMAN SERVICES, (uscfc 2025).

Opinion

In the United States Court of Federal Claims No. 23-230V Filed: February 18, 2025 Reissued: March 11, 2025 1 ________________________________________ ) 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. 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. 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 Althen 3 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 explained 4 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.

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BARRIOS v. SECRETARY OF HEALTH AND HUMAN SERVICES, Counsel Stack Legal Research, https://law.counselstack.com/opinion/barrios-v-secretary-of-health-and-human-services-uscfc-2025.