DOTSON v. SECRETARY OF HEALTH AND HUMAN SERVICES

In the United States Court of Federal Claims

DANIELLE DOTSON, as parent and natural

guardian of B.M., a minor,

Petitioner, No. 17-vv-0637

(Filed Under Seal: July 10, 2025

v. Reissued for Publication: July 25, 2025)

SECRETARY OF HEALTH AND HUMAN

SERVICES,

Respondent.

Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner.

Naseem Kourosh, Torts Branch, Civil Division, United States Department of Justice,

Washington, D.C., for Defendant. With her on the briefs were Yaakov M. Roth, Acting

Assistant Attorney General, C. Salvatore D’Alessio, Director, Heather L Pearlman, Deputy

Director, and Voris E. Johnson, Jr., Assistant Director.

OPINION AND ORDER

Meriweather, Judge.

Petitioner, Danielle Dotson, as parent and guardian of her minor son, B.M., seeks review

of Special Master Moran’s Entitlement Decision (“Decision”), denying her entitlement to

compensation pursuant to the National Childhood Vaccine Injury Act of 1986. See 42 U.S.C.

§§ 300aa-1 to -34 (“Vaccine Act” or “Act”); see generally Pet’r’s Mot. for Review, ECF No. 197

(“Mot.”). Specifically, Ms. Dotson argues that the Special Master’s fact finding concerning her

burden of proof under prong one of the causation-in-fact test set forth in Althen v. Secretary of

Health & Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005), was arbitrary and capricious

because the Special Master “erred . . . by not considering the [record] evidence . . . as a whole[]

and [by] improperly imposing a heightened burden of proof of scientific certainty.” Mot. at 1 ¶¶

1–3. On March 11, 2025, Respondent, Secretary of Health and Human Services (the

“Secretary”) filed his Memorandum in Response to Petitioner’s Motion for Review

(“Response”), wherein he argues that the Special Master properly denied entitlement in this case

because Ms. Dotson failed to “establish by preponderant evidence that the vaccination [] B.M.

received” was the factual cause of his later-developed neurological condition. Resp’t’s Mem. in

 Pursuant to Vaccine Rule 18(b), this Opinion was initially filed on July 10, 2025, and

the parties were afforded fourteen days to propose redactions. The parties did not propose any

redactions and, accordingly, this Opinion is reissued in its original form for publication.

Resp. to Pet’r’s Mot. for Review at 2, ECF No. 199 (“Resp.”). Having considered the parties’

oral arguments, reviewed the relevant filings,1 the law, and for the reasons explained herein, the

Court hereby DENIES Ms. Dotson’s Motion for Review and SUSTAINS the Special Master’s

decision.

BACKGROUND

A. Factual Background

The Special Master set forth the factual and procedural background of this case, including

summarizing B.M.’s medical records for the relevant time period, and both parties’ expert

reports, in his Decision. See generally Decision. For purposes of the pending motion, the Court

will briefly summarize the relevant facts incorporated in that Decision, which are not in dispute.

B.M. was born on August 16, 2013, and on November 7, 2014, he received a ProQuad

vaccine, which is a combined vaccination that “contains attenuated, but live, measles, mumps,

rubella, and varicella2 viruses.” Id. at 2 n.2. On December 2, 2014, B.M. returned to his

pediatrician, presenting with an intermittent fever that started the day before. Id. at 2. That

pediatrician diagnosed B.M. as suffering from fever, seizures, and an ear infection. Id. at 3.

Concerned by the seizures, B.M.’s pediatrician sent B.M. to the emergency room at Norton’s

Children’s Hospital in Louisville, Kentucky. Id.

By the time he arrived at the emergency department, B.M. was actively seizing, and was

quickly transferred to the pediatric intensive care unit. See id. B.M. remained in the hospital for

approximately two weeks, during which time he underwent significant testing—including a brain

CT, a spinal tap, a respiratory pathogen panel, blood work, a brain MRI, a CT angiogram, an

echocardiogram, an MR angiogram, a von Willebrand related antigen panel,3 a second brain

MRI, and flow cytometry—and received varying treatments in an attempt to determine the cause,

and reduce the severity of, his worsening neurological symptoms. Id. at 3–14.

Despite that extensive testing, B.M.’s treating physicians could not identify a clear

1

The following filings are relevant to this Order: Pet. for Compensation, ECF No. 1

(“Pet.”); Am. Pet. for Compensation, ECF No. 64 (“Am. Pet.”); Decision Den. Entitlement, ECF

No. 194 (“Decision”); Mot., ECF No. 197; Resp., ECF No. 199. Throughout, page citations to

documents in the record refer to the document’s original pagination, unless the page is

designated with an asterisk (e.g., *1), in which case the reference is to the pagination assigned by

PACER/ECF.

2

Varicella, colloquially referred to as the chickenpox, is a viral disease commonly

associated with itchy, fluid-filled blisters. Sandeep Kumar & Haitham M. Saleh, Varicella-

Zoster Virus (Chickenpox), NIH (Apr. 27, 2025),

https://www.ncbi.nlm.nih.gov/books/NBK448191/.

3

Von Willebrand factor is a “glycoprotein” that assists with clotting. See Decision at 7.

2

explanation for his symptoms and “drew different conclusions.” See id. at 3–15, 11. Ultimately,

B.M.’s physicians posited that there were “multiple possible etiologies,” id. at 12, which could

explain his symptoms, and made their “[b]est estimate[s]” as to B.M.’s diagnosis, id. at 14,

including considering vasculitis4 and coronavirus OC-43,5 which B.M. tested positive for, see id.

at 4, among other potential causal diagnoses. And although B.M.’s physicians considered the

possibility that the varicella component of his earlier vaccination could have contributed to

B.M.’s symptoms, ultimately, all tests for the presence of the varicella virus were negative. See

id. at 9, 45 (noting that Dr. Gershwin agreed “there is no evidence of infection”); Mot. at 39

(“Neither party to this case has proposed that B.M. got infected with chickenpox.”).

On December 15, 2014, B.M. was discharged from Norton’s Children Hospital to a

rehabilitation hospital. See Decision at 15. On December 19, 2014, B.M. was readmitted to the

hospital due to a high fever. See id. Following his second hospital discharge, B.M. was

readmitted for rehabilitation, where he “received daily physical, occupational, and speech

therapy.” Id. For the remainder of 2015, B.M. continued this therapy and underwent additional

testing. See id. at 15–17. B.M.’s parents reported that he “was making significant gains in

development . . . [h]owever, he [still] could not walk independently,” and his physicians posited

that B.M. would likely “have long-term motor deficits” as a result of his ordeal. Id. at 16–17.

B. Procedural Background

On May 15, 2017, Ms. Dotson filed her Petition for Compensation, wherein she alleged

that various vaccines caused B.M. to suffer acute disseminated encephalomyelitis (“ADEM”),6

which she supported by subsequently filing B.M.’s medical records and various affidavits. See

id. at 17 (citing Pet.). The Secretary “challenged Ms. Dotson’s claim that B.M. suffered from

ADEM and argued that, even if B.M. did suffer from ADEM,” the record evidence was

insufficient to support a finding that any of the vaccines B.M. received was the factual cause of

B.M.’s alleged ADEM diagnosis because “Ms. Dotson did not present expert opinion linking the

vaccination to the alleged condition.” Id. (citing Resp’t’s Rep., ECF No. 20). Accordingly, the

Special Master issued instructions for expert reports, but Ms. Dotson failed to timely submit her

4

Vasculitis involves inflammation of the blood vessels, which can cause organ and tissue

damage. See Vasculitis, Mayo Clinic (Feb. 5, 2025), https://www.mayoclinic.org/diseases-

conditions/vasculitis/symptoms-causes/syc-20363435. There are multiple types of vasculitis,

most of which are uncommon. See id.

5

“OC-43” is one variant of the common human coronavirus, which usually causes mild

to moderate upper-respiratory-tract illnesses. See Common Human Coronavirus, CDC,

https://www.cdc.gov/coronavirus/downloads/Common-HCoV-fact-sheet-508.pdf (last visited

July 9, 2025). “This strain of the coronavirus differs from the strain that caused the pandemic.”

Decision at 4.

6

ADEM is a rare neurological condition causing central nervous system inflammation.

See Acute Disseminated Encephalomyelitis (ADEM), Cleveland Clinic (May 30, 2023),

https://my.clevelandclinic.org/health/diseases/14266-acute-disseminated-encephalomyelitis-

adem. ADEM can be caused by both viral and bacterial infections. See id.

3

expert reports. See id. (citing Order Regarding Expert Reps., ECF No. 22).

Nearly a year later, following repeated extensions, see ECF Nos. 27, 29, 32, 35, 41, Ms.

Dotson still had not filed any expert reports; thus, the Secretary sought dismissal based on the

lack of those reports. See Decision at 18 (citing Mot. to Dismiss, ECF No. 43). Ms. Dotson’s

counsel notified the Special Master that he would file a report from Lawrence Steinman shortly,

and, based upon that representation, the Special Master denied the Secretary’s motion, affording

Ms. Dotson additional time to file Dr. Steinman’s expert report. Id. (setting January 7, 2019 as

the deadline for Ms. Dotson’s expert reports). After another extension, Ms. Dotson finally filed

her expert “report” on April 22, 2019—not from Dr. Steinman as she initially represented—but

from M. Eric Gershwin. Id. (citing Ex. 15, ECF No. 53-1).

1. Dr. Gershwin’s Initial Expert Reports

In Dr. Gershwin’s first “report,” a two-page letter, he did not opine that any vaccination

harmed B.M., nor did he present any conclusions as to a potentially causative medical theory.

See Ex. 15 at 1–2; Decision at 18. Rather, he stated that he “required additional information,” as

described within that two-page letter, to “be in a better position to prepare a report.” Ex. 15 at 1–

2; Decision at 18. The Special Master issued a Show Cause Order, warning Ms. Dotson that her

case may be dismissed for failure to prosecute because although Ms. Dotson “ha[d] been

obligated to file an expert report for a significant time,” she had failed to do so. Order to Show

Cause at 1, ECF No. 54. As the Special Master noted in that Order, Dr. Gershwin’s “report,” “at

its basic level” did not attempt to comply with the instructions for expert reports; did not opine

that any vaccination harmed B.M. in any manner; and Ms. Dotson did not “present any plan by

which she would obtain the information Dr. Gershwin ha[d] requested.” Id. at 2. The Special

Master found that letter was so rudimentary, so conclusory, and so unsupportive of Ms. Dotson’s

case, that he queried whether it had even been “intended for submission to the Court.” Id.

Thereafter, Ms. Dotson filed a six-page report from Dr. Gershwin dated May 14, 2019,

see Ex. 18, ECF No. 55-1, wherein he “opined that a varicella vaccine caused B.M. to suffer

vasculitis,” and stated that he was “concerned about two potential factual errors in the medical

records that will lead to incorrect interpretation of the data and therefore an incorrect diagnosis in

this youngster.” Decision at 18–19 (quoting Ex. 18 at 4–6, ECF No. 55 (discussing two

perceived errors, namely: (1) that B.M. did not have an immune deficiency; and (2) that B.M. did

not suffer from an infection with a coronavirus)).

After the Secretary filed a second motion to dismiss, once again arguing that Ms. Dotson

“failed to meet the requirements for compensation for a causation-in-injury claim” because “Dr.

Gershwin’s reports [were] patently insufficient to meet [her] burden of proof,” Mot. to Dismiss

at 3, ECF No. 56, Ms. Dotson added another report from Dr. Gershwin. See Ex. 40, ECF No. 61.

That supplemental report “is approximately one page. . . . Dr. Gershwin wrote approximately one

sentence on Althen prong one and two sentences on Althen prong two.” Decision at 19 (noting

that the “balance of the report was about Althen prong three”). Although the Special Master

“stretched what Dr. Gershwin had written to understand that Dr. Gershwin may have been

proposing a theory based upon either a varicella infection or hypersensitivity reaction,” id. at 20

(quoting Order to Show Cause, ECF No. 62), the Special Master concluded that neither theory

4

supported Ms. Dotson’s case. Id. at 19–20 (citing Order to Show Cause, ECF No. 62). The

Special Master concluded the first causative theory was “problematic” because “although the

varicella vaccine might lead to a varicella infection as a matter of theory, Ms. Dotson could not

prevail upon this theory” because, as Dr. Gershwin himself acknowledged, “there is no evidence

of infection.” Id. at 20 (citing Ex. 18 at 4). The Special Master similarly concluded that Dr.

Gershwin’s hypersensitivity reaction theory was equally “incapable of resulting in . . .

compensation to Ms. Dotson because: (1) ‘Dr. Gershwin ha[d] not cited evidence that B.M.

suffered an allergic reaction’; and (2) ‘the latency between the vaccination and the date of

hospitalization (25 days) appears to exceed the amount of time [] for an allergic reaction to

manifest.’” Id. (quoting Order to Show Cause at 4, ECF No. 62) (cleaned up). “Thus, Ms.

Dotson was given another opportunity to present a comprehensive, complete, and reliable report

from Dr. Gershwin,” and was “directed to have Dr. Gershwin comply with the instructions.” Id.

(cleaned up).

Although “Ms. Dotson attempted to comply,” id., with the Special Master’s second Show

Cause Order by filing another, approximately eight-page report from Dr. Gershwin, see Ex. 47,

ECF No. 63-1, that report “was not a model of clarity.” Decision at 20. Indeed, “Dr. Gershwin

copied much of the material from his previous reports.” Id. (identifying the ways in which

Exhibit 47 is duplicative). The Special Master found this report so conclusory that “discerning

a[ny medical] theory . . . is difficult.” Id. Dr. Gershwin dedicated a scant, four paragraphs to his

“Theory, Althen 1.” See id. The Special Master summarized Dr. Gershwin’s theory in his

Decision as follows—

[As] Dr. Gershwin wrote: “The ‘theory’ is that Varicella antigens, whether from a

live virus or from a live viral Varicella vaccine can cause CNS vasculitis. The

cause and effect relationship between the Varicella antigen and CNS vasculitis is

known and accepted by the medical community.” For the proposition, that the

medical community accepts this relationship Dr. Gershwin cited a series of case

reports as well as one article, Wise. Under the heading, “Althen III,” Dr.

Gershwin wrote another paragraph and within this paragraph, Dr. Gershwin

discussed timing in the context of molecular mimicry.

Id. at 20–21 (internal citations omitted). Following Dr. Gershwin’s latest report, which the

Special Master initially found was at least “adequate,” Ms. Dotson amended her petition to allege

that B.M.’s varicella vaccine caused B.M. to suffer from vasculitis. Id. at 21 (citing Am. Pet.).

2. Dr. Kruer’s Initial Expert Reports

The Secretary responded to Dr. Gershwin’s opinions by presenting an approximately

four-page report from Dr. Kruer, wherein he requested original images of various studies and

opined that: (1) B.M. likely suffered an infection with a primary coronavirus; (2) “a diagnosis of

vasculitis was never confirmed”; and (3) B.M. suffered a primary immunodeficiency. Id. (citing

Ex. C, ECF No. 70-1). After obtaining those requested diagnostic images, Dr. Kruer submitted a

supplemental report, wherein he contended that Dr. Gershwin failed to “proffer[] a theory of

causality,” and that it was “far more likely than not B.M.’s symptoms were due to the

Coronavirus OC43 in the context of his underlying immunodeficiency.” Id. (quoting Ex. P at 3–

5

4, ECF No. 77-1).

3. Dr. Wilson’s Initial and Dr. Gershwin’s Supplemental Expert

Reports

Thereafter, Ms. Dotson submitted a seven-page report from David Wilson. See Ex. 54,

ECF No. 90-1; Decision at 22. Based on his review of various imaging studies and a “limited

amount of clinical information,” Dr. Wilson acknowledged that “this [was] a challenging case”

and concluded that “the most likely explanation for B.M.’s condition was a vasculopathy7 which

may have been of infectious or immunogenic origin; however, this vasculopathy was almost

certainly not caused by the cited pathogen OC43.” Decision at 22 (quoting Ex. 54 at 2–4)

(internal citations omitted). In reaching this conclusion, Dr. Wilson suggested a number of

different possible diagnoses that might explain B.M.’s symptomology including: (1) a

vasculopathy; (2) a cerebritis/cerebellitis8 caused by an infectious agent; (3) acute demyelinating

injury either ADEM or acute hemorrhagic encephalomyelitis9 (“AHEM”); or (4) an embolic

stroke. See id.

In conjunction with Dr. Wilson’s report, Ms. Dotson submitted another one-page report

from Dr. Gershwin, wherein he largely “agree[d] with Dr. Wilson’s opinions and maintains his

previously expressed opinions,” which he presented in an abbreviated format, i.e., a bulleted list.

See id. (citing Ex. 76, ECF No. 88).

4. Dr. Zucconi’s Initial and Dr. Kruer’s and Dr. Gershwin’s

Supplemental Expert Reports

On January 6, 2021 the Secretary filed a six-page supplemental report from Dr. Kruer,

wherein he largely “agree[d] with Dr. Wilson’s assessment[] [that] B.M.’s neuroimaging [was]

highly unusual” because that imaging “is not ‘typical’ of anything.” Id. at 22–23 (quoting Ex. X

at 1, ECF No. 95-1) (noting that “Dr. Kruer’s opinions were directed to Dr. Wilson” because Dr.

Kruer concluded that “Dr. Gershwin’s report did not contain any new assertions”). Given B.M.’s

atypical diagnostic imaging, Dr. Kruer posited that “we are very likely [] dealing with either a

rare disease, [] an atypical manifestation of a common disease, or some combination of the two.”

Id. at 23 (quoting Ex. X at 1). After accounting for this caveat, Dr. Kruer reiterated his earlier

7

Vasculopathy is a general term that refers to any disease or abnormality affecting the

blood vessels. See Vascular Disease (Vasculopathy), Cleveland Clinic (March 22, 2022),

https://my.clevelandclinic.org/health/diseases/17604-vascular-disease.

8

Cerebritis is a type of encephalitis involving inflammation of the cerebrum, the largest

part of the brain. See Encephalitis, Mayo Clinic (May 16, 2024),

https://www.mayoclinic.org/diseases-conditions/encephalitis/symptoms-causes/syc-20356136.

Cerebellitis is another type of encephalitis involving inflammation of the cerebellum, the part of

the brain largely responsible for controlling muscle movement. See id.

9

AHEM is a rare, central nervous system disease characterized by rapid and progressive

inflammation of the brain’s white matter. See Decision at 21 (citing Ex. 54 at 6).

6

opinion that “the most likely diagnosis” is “an atypical coronavirus OC43 encephalitis in the

context of an underlying immunodeficiency,” the bases for which he then explained in greater

detail in the remainder of his report. Id. (citing Ex. X at 1–5). Within that report, Dr. Kruer also

opined that Dr. Gershwin’s and Dr. Wilson’s reports were insufficient to show that the varicella

vaccine caused B.M. to suffer vasculitis as opposed to a coronavirus infection. Id. (citing Ex. X

at 5–6).

Ms. Dotson submitted another two-page report from Dr. Gershwin, wherein Dr.

Gershwin “agreed B.M.’s symptomologies are unusual” but ultimately maintained that such

symptomologies “are consistent with a [] vasculopathy.” Id. (citing Ex. 77 at 2, ECF No. 99-1).

On May 21, 2021, the Secretary filed a two-page report from Dr. Zucconi, which

addressed why a varicella infection was unlikely and why the imaging supports acute viral

encephalitis, as well as an additional report from Dr. Kruer, which challenged Dr. Gershwin’s

conclusion that a diagnosis of vasculopathy was most likely. Id. at 23 (citing Ex. Y, ECF No.

106-1; Ex. Z, ECF No. 107-1).

5. Dr. Shafrir and Additional Expert Testimony

Given the Special Master’s “interest in allowing Ms. Dotson to present her evidence” he

“permitted [her] to add another expert”; thus, on December 20, 2021, Ms. Dotson submitted an

approximately 50-page report from Dr. Shafrir. Id. at 24. As the Special Master noted, the bulk

of this report, approximately 41 pages, merely summarized B.M.’s medical records through

2016. See id. (citing Ex. 84, ECF No. 124-1). In the remainder of that report, Dr. Shafrir opined

that the three most likely potential causative diagnoses were ADEM, encephalitis, and vasculitis,

and concluded that, of these three possible diagnoses, vasculitis was the most likely. See id.

(citing Ex. 84 at 43–45). The Special Master found that although Dr. Shafrir generally concurred

with Dr. Gershwin that the varicella vaccine was the most likely cause of the vasculitis, “Dr.

Shafrir’s opinion as to a potential causal connection between the varicella vaccine and the

vasculitis was not particularly robust.” Id. (citing Ex. 84 at 44–45) (noting that “Dr. Shafrir

declined to address immunological parts of Dr. Kruer’s second report” and “[l]ikewise . . . did

not discuss the radiology [] addressed by Dr. Wilson and Dr. Zucconi”).

The Secretary responded by filing a pair of supplemental reports from Dr. Zucconi and

Dr. Kruer. See id. (citing Ex. AA, ECF No. 131-1; Ex. BB, ECF No. 132-1). Unsurprisingly,

given Dr. Shafrir’s failure to comment on B.M.’s radiology results, Dr. Zucconi maintained his

initial conclusion that B.M. had acute viral encephalitis caused by a coronavirus infection. See

id. And Dr. Kruer’s six-page report responded to Dr. Shafrir “nearly paragraph-by-paragraph.”

Id. (citing Ex. BB).

In a May 4, 2022 status conference, Ms. Dotson represented that there were no remaining

expert opinions to be proffered in this case; accordingly, the Special Master issued a briefing

order. See id. at 25 (citing Order, ECF No. 135). Despite this representation, Ms. Dotson filed

an additional five-page report from Dr. Shafrir just one week after that briefing order was issued,

which the Special Master noted “criticizes Dr. Kruer with language that is potentially

inflammatory.” Id. at 25 n.14 (citing Ex. 99 at 3, ECF No. 138-1). The Secretary objected to Dr.

7

Shafrir’s report, but the Special Master overruled that objection, allowing the report to remain in

the record, in part, because “the Secretary would not be prejudiced” and “could respond with

more reports.” Id. at 25.

The Secretary filed one last report from Dr. Kruer in response, wherein Dr. Kruer refutes

Dr. Shafrir’s contentions. See id. at 26 (citing Ex. CC, ECF No. 151-1). The parties proceeded

to briefing the issues, including the threshold dispute concerning the appropriate diagnosis for

B.M., with Ms. Dotson “convinced” that the appropriate diagnosis was vasculitis and the

Secretary alternatively contending that B.M. suffered from encephalitis. Id. at 27 (quoting

Pet’r’s Br. at 1, ECF No. 157).

6. The Special Master’s Decision Denying Entitlement and Ms.

Dotson’s Instant Motion

In his Decision, the Special Master, after first assuming for purposes of his argument that

B.M.’s ultimate diagnosis was vasculitis,10 see id. at 30, concluded that “Ms. Dotson [] failed to

meet all the elements necessary to show that the varicella vaccine was the cause-in-fact of (an

assumed) vasculitis.” Id. In reaching this conclusion, the Special Master took the “unusual step”

of allowing Ms. Dotson multiple opportunities to clarify her causative theory as described above,

see id. at 36, then carefully and comprehensively reviewed all of Ms. Dotson’s submitted expert

reports and literature. See id. at 31–42. The Special Master ultimately found that Ms. Dotson

failed to present any theory causally connecting the vaccine at issue to B.M.’s assumed vasculitis

as required under Althen prong one. See id. at 35 (“Ms. Dotson had one final chance to identify

the theories she was asserting by filing a reply brief. However, she was silent.”). Accordingly,

the Special Master denied entitlement, concluding that Ms. Dotson had not met her Althen prong

one burden of proof because she failed to establish by preponderant evidence that B.M.’s

November 7, 2014 vaccination caused him to develop the assumed vasculitis. See id.

On February 10, 2025, Ms. Dotson filed her Motion for Review, arguing that the Special

Master: (1) acted arbitrarily and capriciously when making fact findings concerning Ms.

Dotson’s Althen prong one proof; (2) erred by not “considering the evidence on the record as a

whole”; and (3) erred by improperly heightening Ms. Dotson’s burden of proof to require

“scientific certainty” rather than preponderance. See Mot. at 2. The Secretary contends that the

Special Master, after conducting a “thorough review of the record” and after “thoughtfully

weigh[ing] [all] the evidence,” “properly denied entitlement” in this case. Resp. at 2. On June

20, 2025, the Court held oral argument on Ms. Dotson’s Motion.

10

The Federal Circuit has held that a special master may, in the unusual case where the

alleged injury is disputed, “first determine which injury was best supported by the evidence in

the record before applying the Althen test.” Decision at 30 (quoting Broekelschen v. Sec’y of

Health & Hum. Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010)). Although the Secretary

“maintains . . . that [the] alleged diagnosis of vasculitis was not preponderantly established,” the

Secretary proceeds to “address[] [Ms. Dotson’s] arguments on appeal based upon the Decision as

issued.” Resp. at 4 n.2. Given that Ms. Dotson does not contend the Special Master’s threshold

determination was in error, the Court proceeds on the assumption that the alleged injury in this

case is vasculitis.

8

LEGAL STANDARD

“Under the Vaccine Act, the Court of Federal Claims reviews the decision of a special

master to determine if it is arbitrary, capricious, an abuse of discretion, or otherwise not in

accordance with law.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1350 (Fed.

Cir. 2008) (citing Althen, 418 F.3d at 1277). In Vaccine Act cases, this Court uses three distinct

standards of review—fact findings are reviewed under the “arbitrary and capricious” standard;

legal conclusions are reviewed de novo under the “not in accordance with the law” standard; and

discretionary rulings under the “abuse of discretion” standard. Munn v. Sec’y of Health & Hum.

Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992) (cleaned up).

The arbitrary and capricious “standard of review [applicable to vaccine cases] is uniquely

deferential for what is essentially a judicial process,” and the Federal Circuit has warned against

“second guess[ing] the Special Master[’]s fact-intensive conclusions,” particularly in those cases

“in which the medical evidence of causation is in dispute.” Hodges v. Sec’y of Health & Hum.

Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). “The law is settled that this Court cannot substitute its

judgment for that of the Special Master merely because it might have reached a different

conclusion.” Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 718 (2009) (cleaned up);

see Broekelschen, 618 F.3d at 1345. Thus, this Court “does not reweigh the factual evidence,

assess whether the Special Master correctly evaluated the evidence, or examine the probative

value of the evidence or the credibility of the witnesses.” Broekelschen, 618 F.3d at 1349

(cleaned up). “If [a] special master has considered the relevant evidence of record, drawn

plausible inferences[,] and articulated a rational basis for the decision, reversible error will be

extremely difficult to demonstrate.” Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518,

1528 (Fed. Cir. 1991). Accordingly, this Court should not find that a special master’s fact

conclusions are arbitrary and capricious unless they are “so implausible that [they] could not be

ascribed to a difference in view.” Id. at 1527 (cleaned up). Indeed, if a special master’s

“conclusion is based on evidence in the record that is not wholly implausible, [this Court is]

compelled to uphold that finding as not being arbitrary or capricious.” Cedillo v. Sec’y of Health

& Hum. Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010); see also Lampe v. Sec’y of Health & Hum.

Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000).

DISCUSSION

The Special Master’s Fact Conclusions Under Althen Prong One Were Rational

and Well-Supported.11

The Vaccine Act, enacted in 1986, created the National Vaccine Injury Compensation

Program, through which claimants can petition to receive compensation for vaccine-related

injuries or death. See generally 42 U.S.C. § 300aa-10(a). Under the Act, there are two ways a

11

This section addresses Ms. Dotson’s arguments that the Special Master’s “fact finding

in relation to [her] Althen prong 1 [sic] proof was arbitrary and capricious.” Mot. at 2.

Accordingly, the Court reviews the Special Master’s findings of fact under that “uniquely

deferential” standard of review. Hodges, 9 F.3d at 961; see also Munn, 970 F.2d at 870 n.10.

9

petitioner can establish causation and thus qualify for compensation. First, a petitioner may

establish that the vaccinee, after receiving a designated vaccine, suffered an injury listed on the

Vaccine Injury Table within the requisite time period—commonly called a “Table Injury,” see

42 C.F.R. § 100.3(a)—in which case causation is presumed. See 42 U.S.C. § 300aa-11(c)(1).

Alternatively, if a petitioner claims entitlement for an injury not listed in the Vaccine Injury

Table, i.e., an “Off-Table case,” the petitioner must instead prove that the vaccination was the

cause-in-fact (“actual causation” or “causation in fact”) of the vaccinee’s asserted injury. See id.

§ 300aa-11(c)(1)(C)(ii)(I).

The Federal Circuit has long affirmed that the standard for proving causation in fact

under the Vaccine Act is the same as the standard for proving “legal cause” in the general torts

context. See Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999); de

Bazan, 539 F.3d at 1351. Specifically, the Federal Circuit has “adopt[ed] the Restatement rule

for purposes of determining vaccine injury,” and “[a vaccine] is the ‘legal cause’ of harm if that

[vaccine] is a ‘substantial factor’ in bringing about the harm, and [if] that [] harm would not have

occurred but for the [vaccination].” Shyface, 165 F.3d at 1352 (citing Restatement (Second) of

Torts § 431(a) (Am. L. Inst. 1965)). To establish that a vaccine is a “substantial factor” in

bringing about the alleged harm, the petitioner in an “Off-Table Injury” case such as this one

must satisfy the three-prong test first articulated in Althen and establish—

by preponderant evidence that the vaccination brought about [B.M.’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, 418 F.3d at 1278; see also Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351,

1355 (Fed. Cir. 2019); Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1322 (Fed.

Cir. 2010). It is well-settled that a petitioner must prove “each of the three Althen prongs by a

preponderance of the evidence,” Boatmon, 941 F.3d at 1355, and that “failure to establish any

one prong is dispositive.” Exum v. Sec’y of Health & Hum. Servs., 175 Fed. Cl. 681, 702 (2025).

A. The Special Master Carefully Weighed and Considered All Relevant

Evidence to Support His Well-Reasoned Findings.

Ms. Dotson contends that the Special Master rejected her Althen prong one evidence “out

of hand,” without offering any “reasons,” “explanation,” or “foundation.” Mot. at 27–29. The

Court disagrees. The Special Master afforded Ms. Dotson repeated opportunities to support her

claim, “drew generous inferences in [her] favor,” Resp. at 6, exhaustively reviewed Ms. Dotson’s

briefing and the evidence (even in those circumstances, where it was questionable whether he

was required to do so), and rationally supported his findings in support of his determination that

Ms. Dotson failed to meet her burden under Althen prong one. See Althen, 418 F.3d at 1278.

Accordingly, “reversible error will be extremely difficult to demonstrate.” Hines, 940 F.2d at

1528.

First, the Special Master did not reject Dr. Gershwin’s reports “out of hand,” Mot. at 29,

10

rather, he undertook a “painstaking review” of those reports, “for anything resembling a coherent

theory,” Resp. at 8, but ultimately concluded that Dr. Gershwin’s “attempts to put forward a

minimally competent medical theory fell well short.” Decision at 31. As noted above, Dr.

Gershwin’s first “report,” a two-page letter, was patently insufficient, as, somewhat

confoundingly, given that this a case seeking compensation for an alleged vaccine injury—he did

not opine that any vaccination harmed B.M. See Ex. 15 at 1–2; Decision at 18. That first report

was so conclusory, and so unsupportive of Ms. Dotson’s case, that the Special Master questioned

whether it had even “be[en] intended for submission.” Order to Show Cause at 2, ECF No. 54.

Dr. Gershwin’s second report was equally “problematic.” Decision at 20. Although the Special

Master, again, afforded Dr. Gershwin leniency, “stretch[ing] what Dr. Gershwin had written” to

understand that Dr. Gershwin was proposing either a varicella infection or a hypersensitivity

reaction theory, the Special Master concluded neither of those theories were viable as presented,

id. at 19–21 (quoting Order to Show Cause, ECF No. 62), in part, because as Dr. Gershwin

himself acknowledges, and Ms. Dotson concedes, “there is no evidence of [varicella] infection”

here. Id. at 20 (citing Ex. 18 at 4).

Similarly, Dr. Gershwin’s third report, “copied much of the material” from his previous

two reports, “was not a model of clarity,” and only included four, conclusory paragraphs under

the heading “Theory, Althen I.” Id. at 20 (citing Ex. 47 at 5–6). In that report, Dr. Gershwin

stated “[t]he ‘theory’ is that Varicella antigens, whether from a live virus or from a live viral

Varicella vaccine can cause CNS vasculitis. The cause and effect relationship between the

Varicella antigen and CNS vasculitis is known and accepted by the medical community.” Ex. 47

at 5–6 (citing, in support of this proposition, a series of case reports, and one article, the Wise

article). Despite these clear deficiencies, again, the Special Master afforded significant leniency,

interpreting this report as proposing a causative theory of “molecular mimicry” under Althen

prong one and finding that third report sufficiently “adequate” for the case to proceed. Decision

at 21. But Dr. Gershwin never explained or further elaborated on this theory beyond this cursory

statement in his third report, that is—the “evidence and arguments regarding molecular mimicry

[were] too general to be persuasive.” Id. at 42 (noting that Dr. Gershwin’s reports “at least

mention the idea” of molecular mimicry and that “[h]is second report includes the phrase . . .

‘molecular mimicry’ in the context of Althen prong three”).

In Orloski, the Federal Circuit concluded that the Special Master did not err by refusing

to consider the petitioner’s primary expert opinion which the Special Master determined was

“too conclusory and underdeveloped to be persuasive.” Orloski v. Sec’y Health & Hum. Servs.,

839 Fed. Appx. 538, 541 (Fed. Cir. 2021). In that case, although the Special Master gave the

petitioner “several opportunities to bolster her case and provide a more detailed expert report,”

those reports the petitioner did submit “did not provide any reasoning for how or why [the

vaccinations] would cause” the alleged injury. Id. at 541–42. Here, as in Orloski, the Special

Master afforded Ms. Dotson multiple opportunities to supplement her reports, and specifically

identified why the reports submitted were deficient. But Dr. Gershwin’s ultimate submissions

never articulated “any reasoning for how or why” the varicella vaccination could cause

vasculitis. Id. The Special Master here was “entitled to require some indicia of reliability to

support” Dr. Gershwin’s conclusory assertions, Moberly, 592 F.3d at 1324, he found none, and

the Court declines to “reweigh th[at] [] evidence.” Broekelschen, 618 F.3d at 1349; see also

Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert

11

opinion is no better than the soundness of the reasons supporting it.”).

And, “[f]or [the] sake of completeness,” the Special Master quoted Ms. Dotson’s12

argument concerning Dr. Gershwin’s molecular mimicry causative theory in full—which he was

able to do easily due to its conclusory nature—remarking that she “did not elaborate” on that

argument, “included [a mere] one sentence from three [of the cited] articles,” and “without any

descriptive information,” cited another eight articles. Decision at 33–34. The Special Master

specifically noted that although Ms. Dotson discussed Althen prong one in her brief, she did so

“in approximately two double-spaced pages,” and simply asserted, without support, that “[t]here

is abundant evidence linking varicella to vasculitis,” and “[t]he literature treats it as a given.” Id.

at 32. Notably, this is the same argument that Ms. Dotson quotes verbatim in her pending

Motion. Compare Decision at 33, with Mot. at 17. The Special Master did not err by

“conclud[ing] that there [was] simply too great an analytical gap between the data and the

opinion proffered.” Cedillo, 617 F.3d at 1339.

The Special Master similarly exhaustingly examined the “primary piece of evidence,” in

this case, the Wise article, which Dr. Gershwin cites in both his first and third reports. Decision

at 36; see also Ex. 18 at 5; Ex. 47 at 5. As described by the Special Master, “[i]n this article,

Robert P. Wise and his colleagues searched Vaccine Adverse Event Reporting System

(“VAERS”) . . . [where] [t]hey found 15 cases of vasculitis . . . [a]mong [those] 15 vasculitis

reports, 3 children . . . appeared to have Kawasaki syndrome, and 10 patients developed Henoch-

Schönlein purpura within 7 weeks of vaccination.” Decision at 36 (citing Ex. 37 at 1272–75,

ECF No. 59-3). The Special Master analyzed the Wise article in conjunction with a different

study cited by the Secretary’s expert, Dr. Kruer, in response to the Wise article, and found both

unpersuasive—“[t]he relative weakness of [Dr. Kruer’s cited] article does not elevate the value

of Wise article.” Id. at 37 (criticizing Dr. Kruer’s cited article because “[upon] review of this

article [he] did not readily identify any places in which the authors assessed whether the varicella

vaccine can cause vasculitis”). The Special Master concluded that the Wise article should be

afforded little weight because “Wise’s methodology of extracting data from the VAERS database

is not reliable.” Id. The Special Master did not err in making that finding. Indeed, this “Court

uniformly has upheld [a] [] Special Master’s concerns about the reliability of VAERS data,”

Analla v. Sec’y of Health & Hum. Servs., 70 Fed. Cl. 552, 558 (2006) (collecting cases), and

found that VAERS data “has extremely limited value to prove causation due to the manner in

which it is collected, the lack of confirmation of the reported information[,] and the lack of any

systematic analysis.” Capizzano v. Sec’y of Health & Hum. Servs., 63 Fed. Cl. 227, 231 (2004)

(vacated on other grounds); see also Manville v. Sec’y of Health & Hum. Servs., 63 Fed. Cl. 482,

494 (2004) (affirming special master’s finding that a “VAERS report can be filed by anyone,

thereby bringing into question the quantity and quality of the information gathered and creating

the possibility of bias”). Accordingly, the Special Master’s determination that the VAERS

evidence should be afforded little to no weight was both proper and reasonable. See Ryman v.

Sec’y of Health & Hum. Servs., 65 Fed. Cl. 35, 43 (2005).

Next, the Special Master, acting “out of an abundance of caution” even reviewed those

12

Ms. Dotson’s argument is taken verbatim from Dr. Gershwin’s June 18, 2019 expert

report. Compare Decision at 33 (quoting Pet’r’s Status Report, ECF No. 180), with Ex. 40 at 1.

12

articles Ms. Dotson cited in her briefing “without any explanation of their relevance[,] [which]

could [have] justif[ied] [his] striking th[ose] articles.” Decision at 34 n.23; see also Sheller v.

Sec’y of Health & Hum. Servs., 121 F.4th 1301, 1309 (Fed. Cir. 2024) (concluding that “the

Special Master did not abuse his discretion in striking [certain] medical articles” once he

“assessed the relevance of each medical article and only struck those determined not to be

relevant”). Despite, once again, affording Ms. Dotson this additional leniency, the Special

Master here still concluded that those cited articles did not support Ms. Dotson’s theory of

causation because they were duplicative, “focus[ed] on conditions not at issue in Ms. Dotson’s

case,” and “concern[ed] [] different vaccine[s]” than the vaccine alleged to have caused B.M.’s

vasculitis. Id. (discussing Ex. 71, ECF No. 88-6, and Ex. 73, ECF No. 88-8, which focused on

possible correlations between the varicella vaccine and stroke and ADEM respectively and

explaining that “Ms. Dotson has not persuasively explained why B.M.’s asserted condition [of

vasculitis] is analogous to either” of those two conditions discussed by the proffered evidence)

(also discussing Ex. 35, ECF No. 59-1, “a case report concerning a different vaccine,” i.e., the

herpes zoster vaccine). In other words, some of the materials Ms. Dotson put forth discussed

neither the varicella vaccine nor vasculitis at all. See H.L. v. Sec’y of Health & Hum. Servs., 715

Fed. App’x 990, 996 (Fed. Cir. 2017) (finding no error in a special master’s determination that

certain articles were not persuasive when those “articles discuss circumstances that are not

directly analogous to [the present] case”). The Special Master further found that Exhibit 35, the

Puram case report, was unreliable because it “provide[s] little, if any, information helpful to

determining causation [as] [it] present[s] only a temporal sequence of events in which the

vaccination preceded an adverse health event.” Decision at 34–35 n.23; see also K.O. v. Sec’y of

Health & Hum. Servs., No. 13-vv-0472, 2016 WL 7634491, at *11 (Fed. Cl. Spec. Mstr. July 7,

2016) (“The only Federal Circuit case to discuss the value of case reports in the Vaccine

Program found no error in a special master’s giving the case reports little weight.”). The Special

Master carefully weighed this evidence (even though he conceivably was not required to do so)

to reach plausible conclusions. The Court declines to “second guess” the Special Master’s “fact-

intensive” conclusions, which were well within his purview. Hodges, 9 F.3d at 961.

The Special Master proceeded to comprehensively review each of the remaining articles

proffered by Ms. Dotson, and relied upon by her experts, in turn, including: the Nagel and Gilden

article (Ex. 33, ECF No. 58-6); the Strauss article (Ex. 46, ECF No. 61-7); the Gilden article (Ex.

51, ECF No. 63-5); the Nagel and Bubank article (Ex. 34, ECF No. 58-7; Ex. 57, ECF No. 87-2);

the Rojas article (Ex. 45, ECF No. 61-6); the Guillevin article (Ex. 41, ECF No. 61-2); the

Celluci and Benesler article (Ex. 98, ECF No. 125-5); and the Twilt and Beneseler article (Ex.

87, ECF No. 124-4). See Decision 38–41. Although Ms. Dotson wrote “at least one sentence in

the context of Althen prong one,” about these articles, the Special Master devotes three, single-

spaced pages to his fulsome analysis. Id. at 41. The Special Master afforded these remaining

articles little weight for varying reasons, including that some of those articles, like those articles

discussed above, do not discuss the varicella vaccine or vasculitis. See id. at 40. For example,

he observed that the “Rojas article has limited usefulness in providing a theory to explain how

[the] varicella vaccine can cause vasculitis,” given that the authors “discussed how infections

may induce autoimmune diseases through molecular mimicry[,] [t]hey detail evidence in

approximately a dozen diseases, but none are vasculitis.” Id. He further noted that “Guillevin . .

. did not discuss varicella as an inciting agent.” Id. at 41. Ms. Dotson takes issue with the

Special Master’s approach, contending that he improperly “picked off each piece of [] evidence

13

individually.”13 Mot. at 31. But this Court cannot imagine another way for the Special Master to

have evaluated Ms. Dotson’s evidence other than to look at each article on its own merits.

Rather, as the Secretary posits—“it would be error to fail to review the articles individually and

to instead only consider the literature as an undifferentiated mass” because a special master must

evaluate all the evidence in the record. Resp. at 14; see also Rule 8(b)(1), Vaccine Rules of the

Office of Special Masters (requiring that the Special Master “must consider all relevant and

reliable evidence”); Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 541 (2011)

(“[C]onsistent with the duties imposed by the Vaccine Act, the task of a Special Master is to

consider [all] the relevant evidence in the record.” (internal citations omitted)).

Ms. Dotson’s alternative argument14 that the Special Master failed to review the evidence

in the “record as a whole,” is similarly unpersuasive.15 Mot. at 29, 31–33. That argument is

undermined by Ms. Dotson’s contention that the Special Master diligently “picked off,” id. at 31,

each piece of evidence one by one—if the Special Master reviewed each and every piece of

record evidence, how could he have also failed to review the record in its entirety? There is

simply no indication that the Special Master improperly excluded evidence or failed to consider

Ms. Dotson’s proffered evidence either individually or collectively. Rather, as identified

throughout this Opinion, the Special Master’s review was exhaustive, he acted permissively in

affording Ms. Dotson additional opportunities to present her case, see Decision at 35, assumed

certain arguments on Ms. Dotson’s behalf, see id. at 43, and evaluated evidence that potentially

could have been stricken, see id. at 34 n.23. There is no basis to disturb the Special Master’s

findings of fact on those grounds.

Finally, Ms. Dotson asserts that the Special Master erred by “ignor[ing]” that B.M.’s

treating physicians “included the varicella vaccine in B.M.’s differential diagnosis.” Mot. at 29.

But the Special Master did not ignore B.M.’s medical records—he cited them explicitly

throughout his Decision. See Decision at 8, 11–14. While the Special Master took great care to

relate all B.M.’s relevant medical history and contemporaneous treating physician notes, the

Court notes that perhaps he could have included a more detailed analysis of those records within

his Decision. Regardless of whether this Court may disagree with the weight afforded to that

evidence, the Special Master was “not required to cite to [nor discuss] every piece of evidence so

13

To the extent that Ms. Dotson is arguing that the totality of these articles should have

persuaded the Special Master, despite each of the articles’ individual deficiencies, the Court

agrees with the Secretary that this argument is illogical. See Resp. at 14. “[T]he sum of many

zeros is still zero.” Id.

14

It is unclear whether Ms. Dotson, in making this argument, is asserting that the Special

Master failed to abide by the Vaccine Act; whether she is asserting the Special Master failed to

review the record evidence cumulatively, and therefore assigned that evidence inappropriate

weight; or whether she is asserting that the Special Master improperly excluded certain evidence.

The Court reviews these arguments de novo, under the arbitrary and capricious standard, and

under the abuse of discretion standard respectively. See Munn, 970 F.2d at 870 n.10. Under any

standard of review, Ms. Dotson’s argument is unavailing.

15

See supra note 11 and accompanying text.

14

long as [he] conducts a detailed review of the testimony, medical records, and medical

literature.” Cozart v. Sec’y of Health & Hum. Servs., 126 Fed. Cl. 488, 495 (2016); see also

Simanski v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is

not required to discuss every piece of evidence or testimony in his or her decision.” (collecting

cases)). In fact, as the Federal Circuit has affirmed, this Court presumes that the Special Master

reviewed all the evidence presented absent an explicit expression to the contrary. Hazlehurst v.

Sec’y of Health & Hum. Servs., 604 F.3d 1343, 1352 (Fed. Cir. 2010) (“[E]ven if the Special

Master had made no explicit reference to the [referenced] evidence . . . we would presume that

she considered that evidence.”).

Ultimately, the Special Master, after first generously assuming that Ms. Dotson also

advanced a direct viral invasion theory that was only alluded to in one her articles, but never

directly advanced by her experts, concluded that all of the “theories [presented] lack[ed]

sufficient development” because “one sentence or two sentences [cannot] establish the soundness

of any of them.” Decision at 43–44 (assuming that Ms. Dotson “intended to advance ‘viral

infection’ as a theory to explain how the varicella vaccine can cause vasculitis,” “if only for the

sake of advancing the analysis”). The Special Master gave Ms. Dotson and her experts every

possible opportunity to make their case but found that the evidence presented fell far short of

meeting Ms. Dotson’s burden. Ms. Dotson’s own attempt to show that the Special Master failed

to consider all the evidence, by including block quotations of that allegedly un-reviewed

evidence in her Motion, again only underscores that the Special Master committed no error here

because he, in fact, considered each of those same pieces of evidence. Compare Mot. at 18–23

(citing Ex. 33 (Nagel); Ex. 34, ECF No. 58-7 (Nagel); Ex. 35, ECF No. 59-1 (Puram); Ex. 36,

ECF No. 59-2 (Twilt); Ex. 37 (Wise); Ex. 41 (Guillevin); Ex. 45 (Rojas); Ex. 51 (Gilden); Ex. 87

(Twilt); Ex. 98 (Cellucci)), with Decision at 38–39 (discussing Ex. 33 (Nagel)), 39–40

(discussing Ex. 34 (Nagel)), 19 n.10 (discussing Ex. 36 (Twilt)), 34 n.23 (discussing Ex. 35

(Puram)), 36–37 (discussing Ex. 37 (Wise)), 40–41 (discussing Ex. 41 (Guillevin) and Ex. 45

(Rojas)), 39 (discussing Ex. 51 (Gilden)), 41 (discussing Ex. 87 (Twilt) and Ex. 98 (Cellucci)).

Indeed, after a thorough review of the record evidence and the Special Master’s decision below,

this Court has been unable to identify a single piece of relevant evidence that the Special Master

failed to carefully consider, analyze, and weigh. See Hines, 940 F.2d at 1528.

In sum, the Special Master scoured the record for any evidence that might support Ms.

Dotson’s claim, while affording Ms. Dotson multiple opportunities to correct the deficiencies he

identified, but “simply found the evidence lacking.” Resp. at 11. He comprehensively

considered and weighed both the expert reports and literature, alongside Ms. Dotson’s briefing,

drew plausible inferences, and rationally concluded that Ms. Dotson’s theories were too

unsubstantiated, vague, and undeveloped to carry her burden under Althen prong one. See Hines,

940 F.2d at 1528. Accordingly, this Court is “compelled to uphold that finding as not being

arbitrary or capricious.” Cedillo, 617 F.3d at 1338.

The Special Master’s Conclusion that Ms. Dotson Failed to Satisfy her Burden of

Proof Under Althen Prong One Was in Accordance with the Law.

A. The Special Master Did Not Impermissibly Raise Ms. Dotson’s Burden of

Proof.

15

Ms. Dotson contends that the Special Master improperly heightened her Althen one prong

burden of proof; arguing that the Special Master impermissibly required her to prove causation

by “produc[ing] evidence . . . of scientific certainty” instead of mere preponderance.16 Mot. at

33. Ms. Dotson is correct that “[t]he standard of proof required by the Act is simple

preponderance of evidence . . . not scientific certainty.” Bunting v. Sec’y of Health & Hum.

Servs., 931 F.2d 867, 873 (Fed. Cir. 1991) (emphasis added) (“[I]t is not [petitioner’s] burden to

disprove every possible ground of causation . . . nor must the findings of the [Special Master]

meet the standards of the laboratorian.” (internal citations omitted)); Althen, 418 F.3d at 1280.

In other words, “the statutory standard of preponderance of the evidence requires a petitioner to

demonstrate that the vaccine more likely than not caused the condition alleged.” LaLonde v.

Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1338–39 (Fed. Cir. 2014) (“[T]he burden of

showing something by a preponderance of the evidence . . . simply requires the trier of fact to

believe that the existence of a fact is more probable than its nonexistence.”).

A special master improperly heightens a petitioner’s burden by requiring “objective

confirmation that the vaccine administered is potentially [causative] [of] the injury alleged,”

Althen, 418 F.3d at 1279, either through “identification and proof of specific biological

mechanisms,” or presentation of “epidemiologic studies, rechallenge, the presence of

pathological markers or genetic disposition, or general acceptance in the scientific or medical

communities.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir.

2006) (quoting Althen, 418 F.3d at 1280; Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d

543, 549 (Fed. Cir. 1994)). “[S]uch an approach is inconsistent with allowing the use of

circumstantial evidence envisioned by the preponderance standard.” Id.

And as Althen clarifies, although “scientific certainty” is not the applicable standard of

proof, a petitioner’s “theory of causation must [still] be supported by a reputable medical or

scientific explanation.” Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379–80 (Fed.

Cir. 2009); see also Broekelschen, 618 F.3d at 1345 (“[A] petitioner must provide a reputable

medical or scientific explanation that pertains specifically to the [vaccinee’s] case, although

th[at] explanation need only be ‘legally probable.’”); Knudsen, 35 F.3d at 548 (requiring a

“sound and reliable medical or scientific explanation”). Thus, neither a “special master [n]or

[this] [C]ourt may [] make . . . a finding [of causation] based on the claims of a petitioner alone,

unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1).

Accordingly, the Federal Circuit has “consistently rejected theories that the vaccine only ‘likely

caused’ the [alleged] injury and [has] reiterated that a ‘plausible’ or ‘possible’ causal theory does

not satisfy the [preponderance] standard.” Boatmon, 941 F.3d at 1360 (collecting cases); see

also LaLonde, 746 F.3d at 1339 (“[W]e have made clear that simply identifying a ‘plausible’

theory of causation is insufficient for a petitioner to meet [their] burden of proof.”); Moberly,

592 F.3d at 1322 (noting that the “traditional” standard is “more likely than not” and that “a

[mere] plausible or possible causal link between the vaccine and the injury, [] is not the statutory

16

Ms. Dotson argues that the Special Master erred by improperly heightening her burden

of proof, a legal argument. Accordingly, the Court reviews the Special Master’s conclusion as to

the proper evidentiary burden de novo, but reviews those factual conclusions reached in

assessing whether Ms. Dotson had met the applicable burden of proof under the arbitrary and

capricious standard. See Munn, 970 F.2d at 870 n.10.

16

standard”).

Here, the Special Master did not impermissibly heighten Ms. Dotson’s burden of proof.

Rather, the Special Master properly held Ms. Dotson to a preponderance standard, and simply

found the evidence she presented insufficient to preponderantly establish “a medical theory

causally connecting [the ProQuad] vaccination and [B.M.’s] injury.” Althen, 418 F.3d at 1278.

Indeed, the Special Master correctly identified that Ms. Dotson was “required to establish her

case by a preponderance of the evidence” and took care to note that “[d]istinguishing between

preponderant evidence and medical certainty is important because a special master should not

impose an evidentiary burden that is too high.” Decision at 29 (quoting Andreu, 569 F.3d at

1379–80). The Special Master also correctly stated, in accordance with controlling Federal

Circuit precedent, that “[p]resenting a sound and reliable [medical] theory is essential to Ms.

Dotson’s case” under Althen prong one. Id. at 35; see also Andreu, 569 F.3d at 1379;

Broekelschen, 618 F.3d at 1345; Knudsen, 35 F.3d at 548 (requiring a “sound and reliable

medical or scientific explanation”). “The Decision correctly articulated that standard here.”

Exum, 175 Fed. Cl. at 704. In fact, “the Federal Circuit recently affirmed a different decision of

the Chief Special Master in which he articulated the standard in nearly the same way.” Id.

(citing Kalajdzic v. Sec’y of Health & Hum. Servs., No. 23-cv-1321, 2024 WL 3064398, at *2

(Fed. Cir. June 20, 2024)).

And although the Special Master repeatedly reminded Ms. Dotson of her obligation to

present a viable causative theory, affording her multiple, additional opportunities to present such

a theory, ultimately the “evidence Ms. Dotson [] advanced . . . f[ell] short of meet[ing] her

burden.” Decision at 30, 36 (“After multiple rounds of expert reports and rounds of briefing,

whether Ms. Dotson has disclosed any theory is debatable. Ms. Dotson was notified repeatedly

that the presentation of any theory was not adequate. She did largely not cure this deficiency.”).

In fact, even though “Ms. Dotson had one final chance to identify the theories she was asserting

by filing a reply brief,” she failed to do so. Id. at 35.

Despite Ms. Dotson’s continued failure to put forth evidence sufficient to support any

theory, the Special Master still thoughtfully, carefully, and deliberately reviewed all the evidence

that Ms. Dotson did put forth, as discussed in more detail, supra, ultimately concluding that none

of that evidence “carr[ied] Ms. Dotson’s burden to demonstrate that the varicella vaccine can

cause vasculitis.” Id. at 31–42. Given the Special Master’s careful consideration of the relevant

record evidence, and the plausible inferences drawn therefrom, this Court declines to “reweigh

the factual evidence” and declines to “[re]assess whether the Special Master correctly evaluated

th[at] evidence” to support his conclusion that Ms. Dotson failed to put forth any viable causative

theory. Munn, 970 F.2d at 871.

Contrary to Ms. Dotson’s argument, the Special Master could not have reasonably

determined that Ms. Dotson preponderantly put forth a causative medical theory in this case

because neither the Special Master nor this Court may “make . . . a finding [of causation] based

on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.”

42 U.S.C. § 300aa-13(a)(1). That is, once the Special Master rationally concluded that all of Ms.

Dotson’s potential causative theories “were presented in such an abbreviated form that they are

not sound and reliable,” he was obligated to find that she failed carry her burden under Althen

17

prong one. Decision at 42–43 (“[Ms. Dotson’s] theories lack sufficient development. One

sentence or two sentences do not establish the soundness of any of them.”). It would have been

error for the Special Master to find that Ms. Dotson had met her burden—after finding all the

proffered evidence too vague, irrelevant, and implausible to support any causative theory—

because such a holding would have been premised on nothing other than Ms. Dotson’s assertions

alone. See id. at 45 n.33 (“Ms. Dotson presented negligible support for [her] theories.”). Indeed,

the Federal Circuit has consistently affirmed that mere plausibility is insufficient to meet the

preponderance of evidence standard. See, e.g., Boatmon, 941 F.3d at 1360; W.C. v. Sec’y of

Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (“[P]etitioner must do more than

demonstrate a ‘plausible’ or ‘possible’ causal link between the vaccination and the injury.”). But

see Mot. at 15–17, 26, 29 (referencing a “plausible” medical theory). Accordingly, any such

holding that Ms. Dotson’s causative theory was sufficient on this record would have improperly

lessened Ms. Dotson’s burden of proof under controlling precedent. See Boatmon, 941 F.3d at

1360 (collecting cases); LaLonde, 746 F.3d at 1339 (“[S]imply identifying a ‘plausible’ theory of

causation is insufficient for a petitioner to meet [their] burden of proof.”).

Ms. Dotson’s remaining arguments on this point fare no better.17 Specifically, although

Ms. Dotson argues that the Special Master improperly heightened her burden by requiring her to

produce epidemiological studies to support her claim, see Mot. at 34, the record explicitly

forecloses this argument. While it is true that the Special Master noted that “an affirmative

epidemiological study could have helped Ms. Dotson establish that the varicella vaccine can

cause vasculitis,” he did not in fact require Ms. Dotson to put forth such a study. Decision at 38.

Instead, he clarified—despite Ms. Dotson’s insistence that the Wise article was epidemiological,

he did not believe the Wise paper was an epidemiological study as it lacks the traditional

characteristics of those studies—that “the lack of an epidemiological study does not doom the

claim because a petitioner is not required to present an epidemiologic study.” Id. The Special

Master further noted that: “the Wise study is not persuasive evidence for th[e] proposition” that

the varicella vaccine can cause vasculitis—not because the Wise study is non epidemiological,

but rather because the Wise study itself is unreliable—and cites another Special Master decision

discussing, and discarding, that same study. Id. (citing Stapleford v. Sec’y of Health & Hum.

Servs., No. 03-vv-0234, 2009 WL 1456441, at *8 (Fed. Cl. May 1, 2009) (“[T]he Wise article[]

cannot reasonably be cited as evidence for a conclusion that the varicella vaccine can cause

seizures.”)). Thus, the Special Master did not require Ms. Dotson to proffer epidemiological

studies to support her claims, “he merely discounted the persuasiveness of the one proposed.”

Munoz v. Sec’y of Health & Hum. Servs., 174 Fed. Cl. 276, 289 (2024).

17

“In an attempt to show that the Special Master heightened her burden, [Ms. Dotson]

brings up the Wise paper again and then engages in a hypothetical discussion regarding statistical

significance and confidence intervals.” Resp. at 16–17. The Court agrees with Respondent that

this argument, premised on pure conjecture and speculation, and “devoid of any citations,” is

irrelevant to Ms. Dotson’s pending Motion, as it does not identify any evidence that the Special

Master failed to review, nor does it argue that the Special Master misapplied the law. See id. at

17. The Court therefore declines to address it.

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B. Neither the Special Master nor the Secretary Was Required to Disprove Ms.

Dotson’s Theory of Causation.

At various points throughout her Motion, Ms. Dotson contends that the Special Master

erred by not affirmatively disproving her theory of causation.18 See, e.g., Mot. at 27. For

example, she states, “[w]hat evidence is in this record that SM Moran could rely on to counter

this world class immunologist [and] all of the medical literature . . . ? The answer to this

question is NOTHING.” Id. Ms. Dotson similarly faults the Secretary for failing to disprove her

causative theory. See id. at 24 (arguing that the Special Master’s Decision should be reversed, in

part, because Dr. Kruer failed to provide commentary on Dr. Gershwin’s medical theory);19 id. at

27 (“Dr. Kruer provided no counter opinions.”); id. at 28 (referencing the lack of a “counter

medical opinion”) (contending that none of the “hundreds of medical articles filed in this case . .

. prove[] [] Dr. Gershwin is wrong”). In so arguing, Ms. Dotson “appears to misunderstand the

burden of proof.” Resp. at 6. “[T]he caselaw is clear,” id., “it is [Ms. Dotson’s] burden to prove

causation” in the first instance. W.C., 704 F.3d at 1359. “In Off-Table cases, petitioners bear the

burden to prove actual causation.” Bechel v. Sec’y of Health & Hum. Servs., 168 Fed. Cl. 602,

615 (2023). Neither the Secretary nor the Special Master bore “the burden of proving a prima

facie case.” Doe v. Sec’y of Health & Hum. Servs., 601 F.3d 1349, 1356 (Fed. Cir. 2010).

C. The Secretary Was Not Required to Show an Alternative Cause.

Ms. Dotson argues that the Special Master’s decision should be reversed because the

Secretary failed to present “any viable alternate cause.”20 Mot. at 38. Again, Ms. Dotson is

mistaken on the law—because the Special Master concluded that Ms. Dotson failed to meet her

burden of proof, and because this Court concludes that determination was well-supported and in

accordance with the law—“the Secretary [wa]s not obligated to present an alternative cause.”

Decision at 47.

It is well-settled that the framework articulated in Althen is a burden-shifting framework.

See Bechel, 168 Fed. Cl. at 616 (“If a petitioner presents adequate evidence on the three essential

aspects of causation, and thus makes a prima facie case for liability, the burden shifts to the

Government to prove, by a preponderance of evidence, an alternate cause of the alleged

18

The Court reviews this additional legal argument de novo. See Munn, 970 F.2d at 870

n.10; supra note 11.

19

The Court notes that it might very well have been exceedingly difficult, if not

impossible, for Dr. Kruer to provide substantive commentary refuting each of Dr. Gershwin’s

contentions, although he did in fact attempt to do so, because as the Special Master noted, Dr.

Gershwin’s attempts to “put forward a minimally competent medical theory fell well short.”

Decision at 31. Indeed, it was Dr. Kruer’s opinion that Dr. Gershwin failed to “proffer[] [any]

theory of causality” to which he could respond. Id. at 31–32 (quoting Ex. P at 3) (noting that Dr.

Kruer opined that “petitioner has not offered any cogent theory of causation”).

20

The Court reviews this additional legal argument de novo. See Munn, 970 F.2d at 870

n.10; supra note 11.

19

injury.”); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). That

is, the Secretary is obligated to “show[], also by a preponderance of evidence, that the injury was

in fact caused by factors unrelated to the vaccine” if, and only if, petitioner first “satisfies [her]

burden” to preponderantly meet the three Althen prongs. LaLonde, 746 F.3d at 1338. In other

words, because Ms. Dotson “fail[ed] to establish a prima facie case, the burden [did] not shift to

Respondent.” Exum, 175 Fed. Cl. at 702; de Bazan, 539 F.3d at 1354 (“[T]his latter showing [to

preponderantly establish that the injury was caused by an alternate cause] is the government’s

burden once the petitioner has met her burden.” (emphasis added)). Thus, the Secretary was not

obligated to establish an alternate cause here.

CONCLUSION

Although the Court both understands and appreciates the pain Ms. Dotson experienced

watching her child suffer through a significant and life-altering medical ordeal, for the reasons

set forth herein, the Court finds that the Special Master’s determination that Ms. Dotson failed to

satisfy Althen prong one was neither arbitrary and capricious nor contrary to law. Ms. Dotson’s

Motion for Review, ECF No. 197, is therefore DENIED and the Special Master’s decision is

SUSTAINED. The Clerk shall enter JUDGMENT accordingly.

IT IS SO ORDERED.

________________________

ROBIN M. MERIWEATHER

Judge

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