WALTON v. SECRETARY OF HEALTH AND HUMAN SERVICES

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
NIBERLEY WALTON, * No. 20-791V
* Special Master Christian J. Moran
Petitioner, *
*
v. *
* Filed: July 30, 2025
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Mark Theodore Sadaka, Law Offices of Sadaka Associates, LLC, Englewood, NJ,
for petitioner;
Madelyn Weeks, United States Dep’t of Justice, Washington, D.C., for respondent.
UNPUBLISHED DECISION DENYING COMPENSATION1
Petitioner, Niberley Walton, filed a petition for compensation on June 29,
2020, alleging that the tetanus, diphtheria, and acellular pertussis (“Tdap”) vaccine
she received on December 4, 2018, caused her to suffer from “vaccine-induce
neuropathy, including small fiber neuropathy, and fibromyalgia.” In the
alternative, Ms. Walton alleged that these conditions were significantly aggravated
by the vaccine. On July 24, 2025, Ms. Walton filed a motion for a decision
dismissing her petition.
1 Because this Decision contains a reasoned explanation for the action taken in this case, it must
be made publicly accessible and will be posted on the United States Court of Federal Claims’
website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance
with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and
Promotion of Electronic Government Services). This means the Decision will be available to
anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14
days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. Any changes will appear in the document posted
on the website.
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I. Procedural History
Ms. Walton filed her petition on June 29, 2020, alleging that the Tdap
vaccine she received on December 4, 2018 caused or significantly aggravated her
small fiber neuropathy and fibromyalgia. She submitted medical records over the
next year. Respondent filed his Rule 4(c) Report on November 8, 2021, arguing
that Ms. Walton had not put forth a medical theory to support an onset of small
fiber neuropathy or fibromyalgia within 24 hours. Resp’t’s Rep. at 13.
Respondent also argued that the records do not show that Ms. Walton’s condition
worsened as a result of her vaccination, nor that she suffered from small fiber
neuropathy or fibromyalgia prior to her vaccination. Id. at 15.
The case then moved to the expert stage. See Order, issued Nov. 9, 2021
(proposing draft instructions). Ms. Walton submitted her report from a
rheumatologist, Dr. Axelrod, August 8, 2022. Exhibit 9. Dr. Axelrod opined that
Ms. Walton suffered from both small fiber neuropathy and fibromyalgia, but
recognized that, as he is not a neurologist, he could not comment further about
small fiber neuropathy. Id. at 5.
Respondent filed reports from a neurologist, Dr. Lancaster, and an
immunologist, Dr. Schroeder, on January 30, 2023. Dr. Lancaster stated that Ms.
Walton “may have a mild degree of small fiber neuropathy,” but that it would not
account for many of her symptoms. Exhibit A at 16. He saw no evidence that the
small fiber neuropathy was caused by the vaccine, and stated that the “very rapid
onset and progression of symptoms weighs against a causal link.” Id. Dr.
Schroeder noted that Ms. Walton’s treating doctors generally agreed upon a
diagnosis of fibromyalgia, but the small fiber neuropathy diagnosis was “on softer
ground due to the borderline results from the skin biopsies.” Exhibit C at 7. He
emphasized that “there is no evidence that fibromyalgia is an
inflammatory/autoimmune disorder.” Id. at 13.
A status conference was held on March 21, 2023. The undersigned stated
that there was stronger evidence for fibromyalgia than small fiber neuropathy. The
undersigned also indicated that respondent had presented a strong case against
entitlement, and Ms. Walton had presented no evidence that an increase in
cytokines causes harmful effects. See Order, issued Mar. 23, 2023. Ms. Walton
was given an opportunity to file a supplemental report from Dr. Axelrod
addressing how cytokines cause harmful effects.
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Ms. Walton filed a second expert report from Dr. Axelrod on July 21, 2023.
Exhibit 36. Dr. Axelrod stated that Ms. Walton “developed Fibromyalgia and
perhaps a small fiber neuropathy following Tdap vaccination.” Id. at 2. He stated
that her symptoms were “consistent with expected adverse events within the first
few days” following a Tdap vaccination, and “consistent with the expected
increase in cytokines to vaccination.” Id. at 4. Respondent’s experts disputed that
a rise in cytokines can cause fibromyalgia or small fiber neuropathy. Exhibit E at
2-3; Exhibit F at 5.
A November 20, 2023, order highlighted the deficiencies in Ms. Walton’s
case. The undersigned noted that it was unsettled whether petitioner suffered from
any degree of small fiber neuropathy. Even assuming Ms. Walton suffered from
fibromyalgia, it is not considered an autoimmune disease, making it difficult to
understand how a vaccine might cause the condition. The undersigned stated that
Dr. Axelrod asserted a theory involving cytokines, but had not explained it
persuasively. Ms. Walton was given a “final opportunity to present a supplemental
report from Dr. Axelrod.”
Ms. Walton filed her third report from Dr. Axelrod on April 1, 2024.
Exhibit 54. Dr. Axelrod explained that there is “evidence for involvement of the
immune system in Fibromyalgia,” such as effective treatments, evidence of the
involvement of mast cells, and “retrospective evidence to suggest that Small Fiber
Neuropathy is not a significant contributor to the pathophysiology of
Fibromyalgia.” Id. at 1-2. He described a study by Goebel in which IgG from
humans with fibromyalgia was administered to mice, resulting in both mechanical
and cold hypersensitivity, “suggest[ing] that there are targets of the immune
system in subjects with Fibromyalgia that are responsible for symptoms of
Fibromyalgia.” Id. at 2. Although Dr. Axelrod agreed with Dr. Schroeder that
fibromyalgia appears to be a stress-related disorder, he noted that stress has been
linked to the onset or aggravation of autoimmune diseases, and that stress does not
determine the target for an autoimmune response. Id. at 3.
Dr. Axelrod further opined that Ms. Walton “developed Fibromyalgia and
perhaps a small fiber neuropathy following Tdap vaccination.” Exhibit 54 at 4.
He agreed that “the onset of symptoms within 48 hours of the vaccination is too
fast for a specific immune response,” but posited that her first symptoms were
associated with the “expected increase in cytokines,” and that a secondary adaptive
immune response le to her fibromyalgia and possible small fiber neuropathy. Id. at
6. Dr. Axelrod highlighted LGI1 antibodies as being associated “with a variety of
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clinical presentations, including isolated peripheral nerve hyperexcitability,” and
discussed a potential role of the NMDA receptor in central sensitization. Id. at 6-7.
An Order to Show Cause issued on May 13, 2024. The order advised Ms.
Walton that she had not carried her burden of presenting a minimally persuasive
case that the Tdap vaccine caused her injury. In particular, she had not established
that she suffered from small fiber neuropathy. Furthermore, her more likely injury
of fibromyalgia is not considered an autoimmune disease, making it unlikely to
have been caused by a vaccine. Although Dr. Axelrod argued that the
classification of fibromyalgia continues to change, Ms. Walton had not presented
preponderant evidence that fibromyalgia is autoimmune in nature. Ms. Walton
was directed to explain why her case should not be dismissed for a failure to
present persuasive evidence with an expert report and/or arguments from counsel.
In response, Ms. Walton submitted a report from a neurologist, Dr. Jeret.
Exhibit 56. Ms. Walton stated that Dr. Jeret “confirms her diagnosis, including
small fiber neuropathy . . . [which] is known within the program to be an
autoimmune condition and has been previously linked to vaccinations.” Pet’r’s
Resp. to Order to Show Cause, filed July 19, 2024.
Dr. Jeret explained that symptoms of small fiber neuropathy “vary widely in
features and severity,” and highlighted how petitioner satisfies the Freeman
criteria. Exhibit 56 at 10-11. He contended that “the prevalence of SFN is
probably highly underestimated due to lack of a gold standard for diagnosis and
lack of awareness among clinicians.” Id. at 12. Dr. Jeret also argued that “Recent
data has indicated that FM has an immune base,” describing it an “an emerging
field,” and citing the study by Goebel which Dr. Axelrod referenced. Id.
As to timing, Dr. Jeret stated that it is possible for autoimmune reactions to
occur within one day, citing examples in Pan (four cases of GBS within one day of
DTap) and Agmon-Levin (one case of fibromyalgia within one day of hepatitis B
vaccination). Exhibit 56 at 13. He also explained that “it is accepted that patients
with one autoimmune process are at higher risk for additional autoimmune
processes. Ms. Walton had a history of optic neuritis, which Dr. Jeret described as
“typically autoimmune,” and HELLP syndrome, which he stated “is thought to be
an inflammatory disorder mediated by a complement cascade.” Id. Dr. Jeret also
mentioned that Ms. Walton’s parents both had autoimmune diseases and that these
are often hereditary. “To postulate an autoimmune reaction to a vaccine in such an
individual who was ‘primed’ for a[n] autoimmune event is quite reasonable,” he
concluded. Id.
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In response to Dr. Axelrod and Dr. Jeret’s reports, respondent submitted
supplemental reports from Dr. Lancaster and Dr. Schroder. Addressing Dr.
Axelrod’s report, Dr. Lancaster disputed the idea that fibromyalgia is an
autoimmune disease. Exhibit F (ECF No. 88-1)2 at 1-3. He described Dr.
Axelrod’s theories regarding LGI1 and NMDAR antibodies as unsupported by
literature and noted that Ms. Walton did not have symptoms associated with these
antibodies. Id. at 3. Dr. Lancaster also noted that Dr. Axelrod “discusses
homology but does not define any specific mimic substance in the vaccine and
does not specify what single antigen in Petitioner’s body this triggered an immune
response against.” Id. He maintained that the onset of Ms. Walton’s symptoms
was “too fast for an antibody mechanism, and it is also too fast for a specific T cell
mediated immune response.” Id.
Dr. Lancaster criticized the Goebel paper cited by both Dr. Axelrod and Dr.
Jeret. He referenced his previous report, in which he noted “important limitations”
to this “single study.” Dr. Lancaster explained that animal behaviors cannot be
considered the same as fibromyalgia; the changes were modest and it would be an
overstatement to say the animals had fibromyalgia; some experiments were done
with pooled antibodies from multiple patients, making it unclear how many
patients actually were responsible for the effect; and that there is “no definite proof
of specific antibody . . . being found in patients with fibromyalgia. Exhibit E at 1-
2.
Dr. Lancaster also addressed the Agmon-Levin paper. He characterized the
finding that onset ranged from one day to one year as “implausible on both ends,
since an autoimmune disease . . . would be unlikely to damage the nervous system
to cause chronic pain within 1 day.” Exhibit F at 4. Further, he stated that the
authors “seem to have a very expansive view of causation in attributing any
disease within a year of vaccination to the vaccination. This range is far outside
the usual bounds of vaccine-induced autoimmune disorders.” Id. In all, he opined
that the Agmon-Levin paper “does not provide reliable evidence that vaccination
causes either chronic fatigue syndrome of fibromyalgia.” Id.
As with Dr. Axelrod’s theory, Dr. Lancaster criticized Dr. Jeret’s theory for
lack of detail about how a vaccine could cause fibromyalgia through an
autoimmune mechanism within one day. Id. In his conclusion, he maintained that
Ms. Walton was unlikely to have suffered from small fiber neuropathy, and that it
2 There are two exhibits labeled as Exhibit F. All references to Exhibit F in this order refer to ECF No. 88-1.
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would not account for all her symptoms. Furthermore, he stated the very rapid
onset and progression of symptoms weighed against vaccine causation; and that
Ms. Walton’s expert’s theories were unlikely to be true. Id. at 5. Specifically, he
argued that Dr. Axelrod’s theories “invoked autoimmune processes that have not
been shown to occur, or autoimmune diseases that Petitioner very likely did not
have,” and that homology is not a reliable method to predict autoimmune disease
post-vaccination. He refuted Dr. Jeret’s theories by noting that fibromyalgia is not
treated as an autoimmune disease by the medical community. Id.
Dr. Schroder also responded to Ms. Walton’s experts’ reports. Exhibit G.
Expanding upon Dr. Jeret’s comment about how reliance on subjective complaints
makes diagnosing fibromyalgia and small fiber neuropathy difficult, Dr. Schroder
noted that this also makes mechanistic study difficult. Id. at 1-2. Dr. Schroder
further argued that the onset of Ms. Walton’s symptoms occurred too soon after
her Tdap vaccination to be attributable to an adaptive immune response to the
vaccine. Id. at 2. He explained the timeline of an adaptive immune response,
stating it follows “a predictable pattern” wherein it ultimately takes five to seven
days before anti-antigen activity becomes apparent, with a peak response occurring
around fourteen days after the antigen activation. Id. at 3. Dr. Schroder disputed
that the Tdap vaccine could cause fibromyalgia via molecular mimicry, noting the
“widespread and prolonged” exposure to self-antigen molecular mimics. Id. at 4.
He further noted that Dr. Axelrod acknowledged the commonality of molecular
mimicry despite the infrequency of autoimmune disease. Id. at 5.
Ms. Walton was invited to submit additional expert reports. Order, issued
Dec. 6, 2024. In response, Ms. Walton stated that the parties had already
exchanged reports, and requested a Rule 5 conference to discuss next steps. Pet’r’s
Status Rep., filed Feb. 6, 2025.
To provide guidance and discuss outstanding issues, the undersigned issued
an order again explaining the deficiencies in Ms. Walton’s case. Order, issued
April 3, 2025. Ms. Walton was given an opportunity to consider whether it was
reasonable to continue to pursue her case.
Ms. Walton filed a status report on May 5, 2025, reporting that she had met
with counsel several times to discuss the order and research that she had done. Ms.
Walton wanted to seek a second legal opinion, and requested additional time to
determine her course of action. On June 6, 2025, Ms. Walton filed a status report
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stating that she had “decided to withdraw her case and will be filing a motion to
dismiss shortly.” Ms. Walton filed her motion to dismiss on July 24, 2025.
II. Analysis
To receive compensation under the National Vaccine Injury Compensation
Program (“Program”), a petitioner must prove either 1) that the vaccinee suffered a
“Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations, or 2) that the vaccinee suffered an injury
that was actually caused by a vaccine. See §§ 300aa-13(a)(1)(A) and 300aa-
11(c)(1). Under the Act, a petitioner may not be given a Program award based
solely on the petitioner’s claims alone. Rather, the petition must be supported by
either medical records or by the opinion of a competent physician. § 300aa-
13(a)(1).
In this case, Ms. Walton filed medical records and expert reports in support
of his claim. Nevertheless, Ms. Walton wishes to have her claim dismissed and
judgment entered against her. Given Ms. Walton’s clear intent that a judgment
issue in this case, the undersigned will construe this as a motion filed pursuant to
42 U.S.C. § 300aa-21(b) (regarding involuntary dismissal).
To conform to § 12(d)(3), a decision must “include findings of fact and
conclusions of law.” To conform to section 12(d)(3), a decision must “include
findings of fact and conclusions of law.” For causation-in-fact cases, the Federal
Circuit has defined elements of a petitioner’s claim. Petitioners bear a burden to
show by a preponderance of the evidence that the vaccination brought about their
injury by providing:
(1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was
the reason for the injury; and
(3) a showing of a proximate temporal relationship between vaccination and
injury.
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
As explained in the November 20, 2023; May 13, 2024; and April 3, 2025,
orders, it appears more likely that Ms. Walton suffers from fibromyalgia than
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small fiber neuropathy. Beyond stating that science and research is evolving, Ms.
Walton’s experts do not dispute that fibromyalgia is still predominantly regarded
as a non-autoimmune disease. Without this showing, Ms. Walton’s theory of
molecular mimicry cannot adequately explain how a vaccine would cause her
condition. Moreover, Ms. Walton’s theory of molecular mimicry is too vague to
this carry her burden under Althen. As Dr. Lancaster describes, Ms. Walton’s
theory of molecular mimicry is “unclear” and does not identify which components
of the immune system would have interacted with some other host tissue to trigger
an autoimmune response. Exhibit F at 3. To prevail on a theory of molecular
mimicry, a petitioner must “offer reliable and persuasive medical or scientific
evidence of some kind (whether expert testimony or literature) that suggests the
vaccine components could interact with the self structures as maintained.” Johnson
v. Sec'y of Health & Hum. Servs., No. 14-254V, 2018 WL 2051760, at *26 (Fed.
Cl. Spec. Mstr. Mar. 23, 2018); see also Tullio v. Sec'y of Health & Hum. Servs.,
No. 15-51V, 2019 WL 7580149, at *15 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot.
for rev. denied, 149 Fed. Cl. 448 (2020) (finding that the theory of molecular
mimicry was unpersuasive even when sequence homology was identified).
Furthermore, even assuming that Ms. Walton does have an autoimmune
condition, her experts do not persuasively explain how an autoimmune response
may occur within 24 to 48 hours. Special masters have previously found that
vaccines do not cause autoimmune conditions question. See, e.g., Henry v. Sec’y
of Health & Hum. Servs., No. 17-721V, 2022 WL 2301321, at *35-36 (Fed. Cl.
Spec. Mstr. May 2, 2022) (finding 20 hours too quickly because, in part, Dr.
Gershwin stated that 24-48 hours is needed for a significant IgM response);
O.M.V. v. Sec’y of Health & Hum. Servs., No. 16-1505V, 2021 WL 3183719, at
*47 (Fed. Cl. Spec. Mstr. June 16, 2021) (finding that an innate immune response
cannot cause a demyelinating condition in 24 hours), mot. for rev. denied on
unrelated ground, 157 Fed. Cl. 376 (2021); Samuels v. Sec’y of Health & Hum.
Servs., No. 17-071V, 2020 WL 2954953, at *20-21 (Fed. Cl. Spec. Mstr. May 1,
2020) (finding that petitioner had failed to establish proinflammatory cytokines
could cause demyelinating injuries within 24 hours); Parker v. Sec’y of Health &
Hum. Servs., No. 14-979V, 2019 WL 3425297 at *28-29 (Fed. Cl. Spec. Mstr.
June 24, 2019) (finding 24 hours is an insufficient time for molecular mimicry).
Ms. Walton has therefore not met her burden under Althen.
Thus, this case is DISMISSED WITH PREJUDICE for insufficient
proof. The Clerk shall enter judgment accordingly. See Vaccine Rule 21(b).
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IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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