VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-01735
Package ID: USCOURTS-cofc-1_18-vv-01735
Petitioner: W.G.
Filed: 2018-11-08
Decided: 2024-05-22
Vaccine: influenza
Vaccination date: 2017-09-19
Condition: Bell's palsy, hearing loss and neuropathy
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
W.G., an adult, received influenza and hepatitis B vaccines on September 19, 2017. He filed a petition alleging these vaccines caused him to suffer Bell's palsy, hearing loss, and neuropathy. The court found that these conditions are not listed on the Vaccine Injury Table, requiring W.G. to prove causation-in-fact under the Althen standard. W.G. presented expert testimony from Dr. M. Eric Gershwin, who theorized that a T-cell mediated immune response to the vaccines, triggered by molecular mimicry, caused inflammation in the facial nerve, leading to Bell's palsy. Dr. Gershwin also suggested that W.G.'s pre-existing diabetes made him more susceptible to this vaccine-induced injury. The respondent presented expert testimony from Dr. Thomas P. Leist, who opined that W.G.'s poorly controlled diabetes was the likely cause of his Bell's palsy, citing the high prevalence of diabetes in Bell's palsy patients and evidence of microvascular compromise in W.G. predating the vaccinations. The court assumed, for the sake of argument, that W.G. met the first and third Althen prongs (medical theory and temporal proximity). However, the court found that W.G. failed to establish the second prong (logical sequence of cause and effect). The court noted that Dr. Gershwin conceded that W.G.'s diabetes likely damaged his facial nerve and that Dr. Leist persuasively argued that W.G. provided no evidence to distinguish vaccine-induced inflammation from the undisputed ischemic nerve damage caused by his diabetes. Furthermore, the court found that even if the burden had shifted to the respondent, Dr. Leist's evidence strongly supported diabetes as the cause. Ultimately, the court concluded that W.G. had not preponderantly demonstrated that the vaccines caused his injury and dismissed the case.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_18-vv-01735-0
Date issued/filed: 2024-05-22
Pages: 27
Docket text: PUBLIC DECISION (Originally filed: 2/9/2024) regarding 70 DECISION of Special Master. Signed by Special Master Daniel T. Horner. (ksb) Service on parties made.
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Case 1:18-vv-01735-UNJ Document 78 Filed 05/22/24 Page 1 of 27
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-1735V
Filed: February 9, 2024
Special Master Horner
W.G.,
Petitioner,
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
William E. Cochran, Jr., Black McLaren, et al., PC, Memphis TN, for petitioner.
Bridget Corridon, U.S. Department of Justice, Washington, DC, for respondent.
Decision1
On November 8, 2018, petitioner, W.G., filed a petition under the National
Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10, et seq. (2018),2 alleging that the
influenza (“flu”) vaccine and hepatitis B (“hep B”) vaccines he received on September
19, 2017 caused him to suffer “Bell’s palsy, hearing loss and neuropathy.” (ECF No. 1.)
For the reasons set forth below, I conclude that petitioner is not entitled to
compensation.
I. Applicable Statutory Scheme
Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
1 When this decision was originally filed the undersigned advised his intent to post it 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). In accordance with Vaccine Rule 18(b), petitioner
filed a timely motion to redact certain information. This decision is being reissued with petitioner’s name
reduced to initials. Except for those changes and this footnote, no other substantive changes have been
made. This decision will be posted on the court’s website with no further opportunity to move for
redaction.
2 All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-
10-34.
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Case 1:18-vv-01735-UNJ Document 78 Filed 05/22/24 Page 2 of 27
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination also specified in the Table. If so, the
Table Injury is presumed to have been caused by the vaccination, and the petitioner is
automatically entitled to compensation, unless it is affirmatively shown that the injury
was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A);
§ 300aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
In many cases, however, the vaccine recipient may have suffered an injury not of
the type covered in the Vaccine Injury Table. In such instances, an alternative means
exists to demonstrate entitlement to a Program award. That is, the petitioner may gain
an award by showing that the recipient’s injury was “caused-in-fact” by the vaccination
in question. § 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). In such a situation, of course,
the presumptions available under the Vaccine Injury Table are inoperative. The burden
is on the petitioner to introduce evidence demonstrating that the vaccination actually
caused the injury in question. Althen v. Sec’y of Health & Human Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518,
1525 (Fed. Cir. 1991). In this case, petitioner has alleged that the flu vaccine and the
hep B vaccine caused him to suffer Bell’s palsy, hearing loss, and neuropathy. (ECF
No. 1.) Because these conditions are not listed on the Vaccine Injury Table relative to
the flu vaccine or the hep B vaccine, petitioner must establish that his injury was
“caused-in-fact” by his vaccination(s).
The showing of “causation-in-fact” must satisfy the “preponderance of the
evidence” standard, the same standard ordinarily used in tort litigation.
§ 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525.
Under that standard, the petitioner must show that it is “more probable than not” that the
vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need
not show that the vaccination was the sole cause but must demonstrate that the
vaccination was at least a “substantial factor” in causing the condition, and was a “but
for” cause. Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir.
1999). Thus, the petitioner must supply “proof of a logical sequence of cause and effect
showing that the vaccination was the reason for the injury[,]” with the logical sequence
being supported by “reputable medical or scientific explanation, i.e., evidence in the
form of scientific studies or expert medical testimony.” Althen, 418 F.3d at 1278; Grant
v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). A petitioner
may not receive a Vaccine Program award based solely on his or her assertions; rather,
the petition must be supported by either medical records or by the opinion of a
competent physician. § 300aa-13(a)(1).
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Case 1:18-vv-01735-UNJ Document 78 Filed 05/22/24 Page 3 of 27
In what has become the predominant framing of this burden of proof, the Althen
court described the “causation-in-fact” standard, as follows:
Concisely stated, Althen’s burden is to show by preponderant evidence that
the vaccination brought about her 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 proximate temporal relationship between
vaccination and injury. If Althen satisfies this burden, she is “entitled to
recover unless the [government] shows, also by a preponderance of the
evidence, that the injury was in fact caused by factors unrelated to the
vaccine.”
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner
need not necessarily supply evidence from medical literature supporting petitioner’s
causation contention, so long as the petitioner supplies the medical opinion of an
expert. Id. at 1279-80. The court indicated that, in finding causation, a Program fact-
finder may rely upon “circumstantial evidence,” which the court found to be consistent
with the “system created by Congress, in which close calls regarding causation are
resolved in favor of injured claimants.” Id. at 1280.
As with a Table Injury, respondent may ultimately prove petitioner’s injury to be
due to a factor unrelated to vaccination even if petitioner meets his initial burden of
proof. § 300aa-13(a)(1)(B). Respondent bears the burden of demonstrating the
presence of any alternative cause by preponderant evidence only if petitioner satisfies
his prima facie burden. § 300aa-13(a)(1)(B); Walther v. Sec’y of Health & Human
Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007). However, respondent may also present
evidence relating to an alternative cause to demonstrate the inadequacy of petitioner’s
evidence supporting his case in chief. Nonetheless, petitioner does not bear the burden
of eliminating alternative causes where the other evidence on causation is sufficient to
establish a prima facie case under Althen. de Bazan v. Sec’y of Health & Human
Servs., 539 F.3d 1347, 1352-53 (Fed. Cir. 2008); Walther, 485 F.3d at 1150.
II. Procedural History
Initially, this case was assigned to Special Master Christian Moran. (ECF No. 4.)
Petitioner filed medical records, an affidavit, and a statement of completion, in
December of 2018. (ECF Nos. 9-10; Exs. 1-3.) Petitioner later filed an additional
affidavit on in January of 2019. (ECF No. 13; Ex. 4.) The case was reassigned to the
undersigned on August 27, 2019, while still awaiting respondent’s medical review.
(ECF Nos. 22-24.) Thereafter, petitioner filed additional evidence, including an
immunization authorization form and additional medical records. (ECF Nos. 28, 32;
Exs. 5-6.) Petitioner filed an expert report and supporting medical literature on April 20,
2020. (ECF No. 33; Exs. 7-62.)
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Respondent filed his Rule 4(c) Report, as well as his own expert report and
supporting medical literature, on September 29, 2020. (ECF Nos. 38-40; Exs. A
through A, Tab 4.) Respondent contended that this case is not appropriate for
compensation both because “the report provided by [petitioner’s expert] fails to meet
petitioner’s burden to demonstrate vaccine causation” and “petitioner’s diabetes alone,
is more likely than not the cause of the Bell’s palsy.” (ECF No. 38, pp. 2, 13, 14.)
Petitioner filed a responsive expert report and supporting medical literature on March
11, 2021. (ECF No. 45; Exs. 63-68.) Respondent filed a supplemental expert report on
July 29, 2021. (ECF No. 49; Ex. C.) After receiving preliminary guidance pursuant to
Vaccine Rule 5 (see ECF No. 50), petitioner filed a further expert report and supporting
medical literature in January of 2022. (ECF No. 52; Exs. 69-70.)
A one-day fact hearing was held remotely on August 25, 2022. (See ECF No.
57; Transcript of Proceedings (“Tr”), filed Sept. 19. 2022, at ECF No. 60.) Thereafter,
both parties agreed that the record should be closed. (ECF No. 62.) Petitioner filed a
Motion for Ruling on the Record on December 23, 2022. (ECF No. 64.) Respondent
responded on January 30, 2023, and additionally requested that petitioner file Walmart
pharmacy records. (ECF No. 65, p. 4, n.6.) Petitioner filed a reply and a record from
Walmart certifying that there were no additional records to be filed. (ECF Nos. 66-67;
Ex. 71.)
Petitioner argues that he was correctly diagnosed as suffering Bell’s palsy and
that he has demonstrated each of the three Althen prongs by preponderant evidence,
thereby proving his Bell’s palsy to have been caused by his flu and/or hep B vaccines.
(ECF No. 64, pp. 6-10.) Petitioner asserts that respondent has failed to present reliable
evidence explaining petitioner’s condition and that no other antecedent events are
evidenced to explain petitioner’s Bell’s palsy. (Id. at 11.) Respondent disputes that
petitioner has satisfied any of the three Althen prongs. (ECF No. 65, pp. 19-33.)
Respondent contends that the burden of proof did not shift to respondent in this case;
however, respondent stresses in the context of Althen prong two that petitioner’s
uncontrolled diabetes is the likely cause of petitioner’s Bell’s palsy. (Id. at 30-32.) In
reply, petitioner contends that respondent’s expert did not actually challenge petitioner’s
expert on any of the details of his opinion relative to the requirements of Althen, but
instead only offered petitioner’s diabetes as an alternative cause of his condition. (ECF
No. 66.)
This case is now ripe for resolution. I have concluded that the parties have had a
full and fair opportunity to develop the record and that it is appropriate to resolve this
case without an entitlement hearing. See Kreizenbeck v. Sec’y of Health & Human
Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (citing Simanski v. Sec’y of Health &
Human Servs., 671 F.3d 1368, 1385 (Fed. Cir. 2012); Jay v. Sec’y of Health & Human
Servs., 998 F.2d 979, 983 (Fed. Cir. 1993)); see also Vaccine Rule 8(d); Vaccine Rule
3(b)(2).
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III. Factual History
a. As reflected in the medical records
i. Pre-vaccination
Petitioner was diagnosed with type 2 diabetes prior to 2014. (Tr. 8-9, 35.) The
medical records reflect that, throughout 2014, petitioner’s diabetes was uncontrolled
and, as a result, he suffered several injuries, including osteomyelitis in his right toe,
diabetic peripheral vascular disease, peripheral neuropathy, hypertension, benign
hyperkeratotic lesions, and diabetic retinopathy. (Ex. 2, pp. 6-153, 735-60, 813-19.)
After petitioner’s appointment on August 19, 2014, there is a significant gap in
treatment until August 22, 2017, when he saw optometrist Dr. Haleh Shafa. (Ex. 2, pp.
136-53, 157-84.) During these three years, petitioner was taking “Insulin 70/30 25 units
in the mornings and 17 units in the evenings.” (Id. at 162.) At this appointment,
petitioner’s glucose was 134 mg/dL (reference range 70-140 mg/dL) and his
hemoglobin A1C was high at 11.0% (reference range 4.8-5.6%). (Id. at 169-76.)
Additionally, petitioner’s cholesterol was high at 239 mg/dL (reference range 0-199
mg/dL). (Id. at 172, 766.) During this appointment, petitioner received a pneumococcal
vaccination, as well as the first dose of a three-part hep B vaccine series. (Id. at 161,
182.) Additionally, at this appointment, petitioner underwent retinal imaging screening
for diabetic retinopathy, which found minimal diabetic retinopathy in petitioner’s right
eye. (Id. at 168-69.)
Petitioner’s next appointment was on September 14, 2017, where he was seen
by podiatrist Dr. Lisa B. Michaels. (Ex. 2, pp. 188-99.) During this appointment,
petitioner’s chief complaint was “an open lesion” on his left foot, and it was noted that
petitioner had a history of “peripheral neuropathy.” (Id. at 189.) Dr. Michaels recorded
a history of “uncontrolled” type 2 diabetes and diagnosed petitioner with a “diabetic
neuropathic ulceration.” (Id. at 189, 191.) During this appointment, Dr. Michaels
performed a selective wound debridement and removed the devitalized tissue from
petitioner’s foot. (Id. at 191.) This tissue was tested, and the results revealed a
staphylococcus infection. (Id. at 194-95, 770.) Additionally, petitioner underwent an x-
ray of this foot, which found “no fracture dislocation or osseous destruction.” (Id. at 193,
819.) At this appointment, petitioner’s glucose was high at 213 mg/dL (reference range
70-140 mg/dL). (Id. at 194, 773.) Additionally, petitioner’s urine contained high levels of
microalbumin at 47.3 mg/dL (reference range 0.0-2.0 mg/dL) and albumin at 201.5
mg/gm (reference range 0.0-30.0 mg/gm). (Id. at 771.)
On September 15, 2017, petitioner returned to Dr. Shafa for a diabetic eye exam.
(Ex. 2, pp. 203-14.) During this appointment, petitioner was diagnosed with bilateral
moderate nonproliferative retinopathy, as well as amblyopia and low visual impairment
of the left eye. (Id. at 211.)
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ii. Vaccination and subsequent course
On September 19, 2017, petitioner saw Dr. Delphanie D. Head for a routine
follow up. (Ex. 2, pp. 218-38.) During this appointment, petitioner received the flu and
hep B vaccines that are at issue in this case. (Id. at 224-26, 236; Ex. 5, p. 6.) Petitioner
underwent a right upper quadrant ultrasound during this appointment, which found no
abnormalities. (Ex. 2, p. 225.) Petitioner’s glucose was high at 216 mg/dL (reference
range 70-140 mg/dL), his microalbumin was high at 45.3 mg/dL (reference range 0.0-
2.0 mg/dL), and his albumin was high at 251.5 (reference range 0.0-30.0 mg/gm). (Id.
at 226-28, 774, 781.) Petitioner also had a liver function test, which revealed that
petitioner’s ALT was high at 95 IU/L (reference range of 9-33 IU/L) and his AST was
high at 90 IU/L (reference range 12-41 IU/L). (Id. at 228, 779-80.)
Petitioner saw Dr. Rae A. King on September 26, 2017, for an eye exam. (Ex. 2,
pp. 242-52.) Dr. King noted that petitioner’s diagnoses included mild diabetic
retinopathy, childhood left eye trauma, left eye aphakia, and a cataract in his right eye.
(Id. at 247.) On September 29, 2017, petitioner underwent an ultrasound of his right
upper quadrant that was determined to be unremarkable. (Id. at 820-21.) Petitioner
returned to Dr. Michaels on October 3, 2017, for a follow up appointment for the ulcer
on his left foot. (Id. at 256-62.) During this appointment, petitioner underwent another
selective wound debridement to remove devitalized tissue on his left foot. (Id. at 259.)
On October 14, 2017, petitioner presented to urgent care with complaints of
facial droop on the right side; however, the physician observed that petitioner’s facial
droop was on the left, rather than the right. (Ex. 2, pp. 266-88, 733-34.) Patient
underwent an electrocardiogram (“EKG”), which was normal; a computed tomography
(“CT”) scan, which was unremarkable; and a magnetic resonance imaging (“MRI”),
which showed no acute ischemic event, no enhancing intracranial mass, and mild non-
enhancing white matter disease of the brain. (Id. at 270-73, 822-24.) At this
appointment, petitioner’s glucose was high at 129 mg/dL (reference range 70-99 mg/dL)
and his ALT and AST were high at 82 IU/L (reference range 9-33 IU/L) and 77 IU/L
(reference range 12-41 IU/L), respectively. (Id. at 271-72, 782, 784.) Petitioner’s
differential diagnosis at this appointment was between a cerebrovascular accident,
transient ischemic attack, Bell’s palsy, and electrolyte abnormalities. (Id. at 269.)
Petitioner was prescribed 20 mg of prednisone and 400 mg of acyclovir. (Id. at 268.)
Petitioner saw Dr. Head on October 17, 2017, for a follow up evaluation for Bell’s
palsy. (Ex. 2, pp. 292-306.) Petitioner described his symptoms as including light
sensitivity in his left eye, an inability to close/bling his left eye, and a protrusion of the
left eye, as well as slurred speech and twitching/paralysis of the left side of the face.
(Id. at 293.) Dr. Head decreased petitioner’s dosage of prednisone to 10 mg. (Id. at
297.) During this appointment, petitioner’s glucose was high at 155 mg/dL (reference
range 70-140 mg/dL) and his hemoglobin A1C was high at 8.90% (reference range =>
6.99%). (Id. at 300-02, 786-89.)
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On October 24, 2017, petitioner had a follow up appointment with his
ophthalmologist, Dr. King. (Ex. 2, pp. 320-29.) Dr. King noted that petitioner was
experiencing left eye foreign bodies, redness, pain, and light sensitivity with some
tearing. (Id. at 321.) Petitioner saw his podiatrist, Dr. Michaels, on October 31, 2017,
for a follow up regarding the ulcer on his left foot. (Id. at 333-40.) Petitioner underwent
another selective wound debridement to remove devitalized tissue on his foot. (Id. at
336.)
On November 2, 2017, petitioner saw Dr. Shafa for a follow up regarding his eye
pain. (Ex. 2, pp. 344-54.) He reported feeling a foreign body sensation and upper lid
swelling. (Id. at 345.) Dr. Shafa noted that petitioner had been diagnosed with Bell’s
palsy in his left eye and has been unable to fully close his left eye. (Id.) Petitioner’s left
eye exam revealed a “capped glands upper lid, swollen lid, internal chalazion,” an
exposed cornea when blinking, a scar over his cornea, lens fragments attached to iris,
vitreous syneresis, and hazy view. (Id. at 348-49.) Petitioner saw Dr. Shafa again on
November 9, 2017, for a “follow up on chalazion.” (Id. at 359.) Dr. Shafa again noted
that petitioner had recently been diagnosed with Bell’s palsy in his left eye. (Id.) At this
encounter, petitioner was assessed as suffering from Bell’s palsy with exposure
keratopathy in his left eye. (Id. at 362-63.) He was instructed to continue using Systane
drops and Genteal nighttime ointment. (Id.)
Petitioner began seeing neurologist Dr. Joseph A. Wapenski on November 13,
2017, “for left facial paralysis” and Bell’s palsy. (Ex. 2, pp. 371-78.) Dr. Wapenski notes
that petitioner’s facial paralysis began on October 14, 2017. (Id. at 371.) He describes
petitioner’s paralysis as “moderate” with “some drooling left corner of mouth and left eye
irritation and altered taste.” (Id.) He noted that petitioner underwent a CT scan, which
was normal, and an MRI, which showed small vessel white matter disease. (Id. at 371-
72.) Dr. Wapenski acknowledged the fact of petitioner’s flu and hep B vaccinations on
September 19, 2017, but also noted petitioner’s history of uncontrolled diabetes. (Id.)
He noted that petitioner was treated with prednisone and acyclovir. (Id. at 371.)
Petitioner reported experiencing temporary paresthesia and weakness of his left leg, as
well as elevated glucose levels after starting steroids. (Id. at 372.) During petitioner’s
examination, Dr. Wapenski noted that petitioner’s face showed “asymmetry with
weakness of the face drooling left corner of mouth,” and that petitioner could “voluntarily
close and cover entire left eye with eyelid.” (Id. at 375.) Petitioner was assessed as
having left-side Bell’s palsy and a resolved transient lower left leg radiculopathy. (Id.)
On November 14, 2017, petitioner saw Dr. Michaels for another follow up for the
ulcer on his left foot. (Id. at 382-88.) At this appointment, petitioner’s diagnosis was
ulcer of the left toe and type 2 diabetes with neurological manifestation. (Id. at 385.)
Petitioner underwent another selective wound debridement and the devitalized tissue
was removed. (Id.)
On November 17, 2017, petitioner began seeing an acupuncturist to treat his
Bell’s palsy. (Ex. 3, p. 1.) The acupuncturist noted that petitioner reported symptoms “2
weeks after flu shot” and noted that petitioner experienced light sensitivity and dry eyes.
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(Id.) The acupuncturist recommended attending appointments two times a week for
four weeks. (Id.) Petitioner thereafter attended additional acupuncture appointments on
November 18, November 20, and December 11, 2017. (Id. at 1-2.)
Petitioner had another follow up appointment with Dr. Michaels on November 28,
2017. (Ex. 2, pp. 392-98.) Petitioner underwent another selective wound debridement
to remove devitalized tissue. (Id. at 394-95.) Petitioner’s primary care physician, Dr.
Head, saw him for a routine follow up the next day on November 29, 2017. (Id. at 402-
17.) At this appointment, petitioner’s glucose was within the normal range at 124 mg/dL
(reference range 70-140 mg/dL); however, his hemoglobin A1C was high at 9.30%
(reference range <=6.99%). (Id. at 410-11, 790-91.) Dr. Head directed petitioner to
follow up with his neurologist and ophthalmologist for his left Bell’s palsy. (Id. at 407.)
Petitioner followed up with his optometrist, Dr. Shafa, on December 7, 2017, for
his keratitis and Bell’s palsy. (Ex. 2, pp. 421-32.) Dr. Shafa instructed petitioner to
continue using Systane drops and Genteal nighttime ointment. (Id. at 427.)
Additionally, Dr. Shafa noted that petitioner was experiencing “mild iritis” in his left eye,
and she was unsure of whether it was related to his Bell’s palsy. (Id.) Petitioner was
prescribed Pred Forte eye drops. (Id.) On December 12, 2017, petitioner saw Dr.
Michaels for another follow up regarding the ulcer on his left foot. (Id. at 436-41.) At
this appointment, Dr. Michaels determined that petitioner’s ulcer was healed. (Id. at
438.)
On January 5, 2018, petitioner continued his care with Dr. Shafa. (Ex. 2, pp.
445-56.) Dr. Shafa noted that petitioner’s iritis had resolved, but continued to
recommend petitioner use Systane drops and Genteal nighttime ointment to treat Bell’s
palsy. (Id. at 451.) Petitioner’s left eye exam revealed an exposed cornea, a scar
across the cornea, lens fragments, and a hazy view. (Id. at 449-50.)
Petitioner saw his neurologist, Dr. Wapenski, on January 8, 2018 for another
follow up regarding his Bell’s palsy. (Ex. 2, pp. 460-66.) Dr. Wapenski described
petitioner’s “mild left face residua” as “much better,” and noted that he continued to
suffer from “left eye exposure keratitis.” (Id. at 461.) Dr. Wapenski’s impression
described petitioner’s condition as “Neuropathy diabetic,” “Resolving Bell’s Left,” and
“Old left eye injury.” (Id. at 462.) Additionally, petitioner noted distorted hearing in his
left ear. (Id.) On January 10, 2018, petitioner saw Dr. Head for a routine follow up. (Id.
at 470-85.) At this appointment, petitioner’s hemoglobin A1C was high at 8.80%
(reference range <=6.99%), and his ALT and AST were high at 49 IU/L (reference range
9-33 IU/L) and 51 IU/L (reference range 12-41 IU/L), respectively. (Id. at 476-77, 794,
796-97.) Petitioner saw Dr. Michaels on January 29, 2018, for a follow up regarding the
ulcer on his left foot. (Id. at 489-95.) Petitioner’s ulcer remained healed. (Id. at 492.)
On February 5, 2018, petitioner saw Dr. Wapenski again. (Ex. 2, pp. 496-508.)
Dr. Wapenski noted that petitioner’s Bell’s palsy “is showing very good recovery” and
“[h]e can almost completely cover his left eye.” (Id. at 500.) Petitioner was still
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experiencing “mild weakness of the left face,” “left ear hearing distortion,” and
“paresthesia of the chest,” left abdomen, and left leg. (Id.)
Petitioner saw his primary care physician on February 12, 2018, for a routine
follow up. (Ex. 2, pp. 512-23.) During this visit, petitioner’s glucose was high at 194
mg/dL (reference range 70-140 mg/dL), and his hemoglobin A1C was high at 8.80%
(reference range <=6.99%). (Id. at 517-19, 798-99.)
On February 16, 2018, petitioner saw Dr. Dennis L. Frew regarding “hearing
issues in [his] left ear.” (Ex. 2, pp. 527-32.) Dr. Frew noted that petitioner “presents for
left sided Bell’s palsy with onset October 2017 and treated with steroids and has a past
medical history of [uncontrolled type 2 diabetes, hypertension, hyperlipidemia, left
aphakia, left Bell’s palsy, and left eye trauma].” (Id. at 527-28.) Petitioner underwent a
CT, which came back as normal. (Id. at 529-30, 825-26.) Roughly three weeks later,
on March 8, 2018, petitioner saw Dr. Frew again for a follow up on his audio exams.
(Id. at 536-44.) Dr. Frew noted that petitioner had “left moderate sensorineural hearing
loss.” (Id. at 536.) Thereafter, petitioner underwent a brain MRI that revealed “[n]o
significant abnormality . . . in either facial nerve,” and “[n]o areas of abnormal
enhancement in either IAC.” (Id. at 540, 827-28.)
On March 12, 2018, petitioner had an appointment with ophthalmologist Dr.
Seongmu Lee for an eyelid evaluation. (Ex. 2, pp. 548-58.) Dr. Lee found that
petitioner’s facial function was improving and recommended “aggressive ocular surface
lubrication.” (Id. at 554.) Additionally, Dr. Lee discussed implanting gold weights or
tarsorrhaphy surgery to close petitioner’s eyelid if his symptoms got worse. (Id.)
Petitioner had a follow up appointment with Dr. Michaels for the ulcer on his left foot.
(Id. at 562-69.) Dr. Michaels noted that petitioner’s ulcer remained healed. (Id. at 563.)
On April 3, 2018, petitioner had a follow up appointment with Dr. Head. (Ex. 2,
pp. 573-86.) Petitioner’s glucose was slightly elevated at 144 mg/dL (reference range
70-140 mg/dL), his hemoglobin A1C was high at 8.80% (reference range <=6.99%), his
cholesterol was high at 206 mg/dL (reference range 0-199 mg/dL), and his ALT and
AST were high at 45 IU/L (reference range 9-33 IU/L) and 55 IU/L (reference range 12-
41 IU/L), respectively. (Id. at 579-82, 803-10.) On April 16, 2018, petitioner presented
to Dr. Michaels for a follow up regarding the ulcer on his left foot. (Id. at 590-97.) There
were no significant changes during this appointment. (Id.)
On May 21, 2018, petitioner had a follow up appointment with Dr. Lee regarding
his eyelid. (Ex. 2, pp. 601-10.) Petitioner reported “dryness and tearing on/off.” (Id. at
602.) Dr. Lee again noted that petitioner should continue “aggressive ocular surface
lubrication,” and discussed the surgical options to help close petitioner’s eyelid. (Id. at
606.) Petitioner “elect[ed] [the] nonsurgical plan.” (Id.) On May 24, 2018, petitioner
had a follow up appointment with his neurologist, Dr. Wapenski, for paresthesia in his
chest and left facial palsy. (Id. at 614-27.) After reviewing petitioner’s old MRI and CT
scan, Dr. Wapenski ordered an MRI of petitioner’s neck, as well as an electromyogram
and nerve conduction study (EMG/NCV) to documents neuropathy in petitioner’s left
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extremities. (Id. at 619-27.) On June 15, 2018, petitioner underwent an MRI of the
cervical spine that showed “left paracentral disc protrusion with minimal effacement of
the left ventral aspect of the spinal cord contributing to his mild spinal canal stenosis,”
and “[d]isc osteophyte complexes which appear predominately osteophytic . . .
contributing to mild spinal canal stenosis.” (Id. at 623-25, 829-30.) Petitioner had a
follow up appointment with Dr. Michaels on May 29, 2018, during which it was
determined that the ulcer on his left foot remained healed. (Id. at 631-38.)
Petitioner saw Dr. Frew on June 22, 2018, for a follow up regarding his Bell’s
palsy and hearing loss. (Ex. 2, pp. 642-46.) Petitioner noted that he had “no
improvement from initial exam.” (Id. at 642.) Dr. Frew ordered a repeat audio exam
and requested that petitioner follow up after the exam. (Id.) On June 28, 2018,
petitioner saw Dr. Lee for a follow up regarding his left eye. (Id. at 650-59.) During this
appointment, petitioner’s left eye was “very red and irritated.” (Id. at 651.) Petitioner
reported using Genteal gel, which had been working well until that week. (Id.) Dr. Lee
recommended continuing “aggressive ocular surface lubrication.” (Id. at 656.)
Petitioner was prescribed Maxitrol for his irritation. (Id. at 658.) At his follow up
appointment on July 9, 2018, petitioner reported that his eye was “[n]o longer irritated.”
(Id. at 664.) On July 11, 2018, petitioner underwent an EMG/NCV that showed
“electrophysiological evidence for severe, ongoing and chronic, generalized
polyneuropathy with axonal>demyelinating features,” as well as “a superimposed left S1
radiculopathy and a mild median neuropathy at the left wrist.” (Id. at 676-98.)
On July 20, 2018, petitioner saw an ophthalmologist Dr. Essence C. Bell for a
follow up regarding his glaucoma. (Ex. 2, pp. 702-13.) Petitioner complained of right
eye pain and swelling. (Id. at 703.) Petitioner noted that he had been applying Maxitrol,
which helped. (Id.) Petitioner was diagnosed with an age related cataract and
proliferative retinopathy in his right eye. (Id. at 707.) Petitioner had a follow up
appointment with ophthalmologist Azad Mansouri, M.D., on August 3, 2018, for a
diabetic retinal evaluation. (Id. at 717-29; Ex. 6, pp. 4-20.) Petitioner was diagnosed
with severe nonproliferative diabetic retinopathy. (Ex. 2, p. 723; Ex. 6, p. 14, 46-47.)
Petitioner underwent an intravitreal injection of Avastin into his right eye and cataract
surgery in his left eye. (Ex. 2, p. 724; Ex. 6, pp. 16, 18.) Additionally, petitioner
underwent an ocular coherence tomographic study, which confirmed petitioner’s
diagnosis. (Ex. 6, pp. 24-26.)
On August 19, 2018, petitioner saw Dr. Head for a diabetic screening. (Ex. 6, pp.
29-31.) Petitioner had a follow up appointment with Dr. Lee on August 20, 2018. (Id. at
34-36.) Petitioner had another appointment with Dr. Lee on October 8, 2018. (Id. at 83-
98.) Petitioner reported feeling a foreign object sensation and dryness in his left eye.
(Id. at 85.) Dr. Lee recommended petitioner “continue aggressive ocular surface
lubrication.” (Id. at 89.)
Petitioner began participating in a diabetes and hypertension panel management
program on October 15, 2018. (Ex 6, pp. 107-10.) At that time, petitioner was overdue
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for a hemoglobin A1C test, a foot exam, flu and hep B immunizations, and a
microalbumin test. (Id. at 109.)
On November 12, 2018, petitioner followed up with Dr. Lee regarding his Bell’s
palsy. (Ex. 6, pp. 129-44.) Petitioner reported that he noticed numbness and tightness
in his face. (Id. at 131.) There were no significant changes during this appointment.
(Id. at 127-44.) Petitioner had a follow up neurology appointment with Dr. Sonal R.
Hazariwala on November 15, 2018. (Id. at 159-79.) Dr. Hazariwala noted that
petitioner had previously been diagnosed and treated for facial tingling and paresthesias
and has since developed “numbness along the inside of the jaw/cheek.” (Id. at 160.)
During this appointment, petitioner underwent a magnetic resonance angiography
(“MRA”) of his head and neck, which showed no acute intracranial abnormality and no
cervical abnormality; however, there was evidence of an intracranial aneurysm. (Id. at
170.) Dr. Hazariwala diagnosed petitioner with “[l]eft facial numbness” of “unclear
etiology.” (Id. at 167.) He noted that, although petitioner’s tightness may be related to
his Bell’s palsy, the “numbness is concerning.” (Id.) Additionally, he discussed
petitioner’s EMG/NCS results and diagnosed petitioner with polyneuropathy. (Id.)
Petitioner’s labs during this appointment showed high microalbumin at 46.0 mg/dL
(reference range 0.0-2.0 mg/dL) and high albumin at 384.9 mg/gm (reference range 0.0-
30.0 mg/gm). (Id. at 189.)
On February 11, 2019, petitioner called to schedule a podiatry appointment
regarding a potential ulcer on his left foot. (Ex. 6, pp. 290-92.) He saw Dr. Michaels on
February 12, 2019, who confirmed that petitioner had an ulcer on his left foot. (Id. at
308-11.) During this appointment, petitioner underwent an x-ray that showed no
evidence of osteomyelitis and an excisional wound debridement. (Id. at 311-15, 328-
29.) At this appointment, petitioner’s hemoglobin A1C was high at 10.3% (reference
range <=7.0%). (Id. at 341-42.) On March 5, 2019, petitioner called his doctor’s office
and noted that he had an allergic reaction to medication. (Id. at 374-81.) Petitioner saw
Dr. Michaels the next day to address these side effects. (Id. at 385-96.) During this
appointment, petitioner underwent a selective wound debridement. (Id. at 389.)
Petitioner’s labs showed that his red blood cell count was low at 3.92 10*6 uL (reference
range 4.06-5.69 10*6 uL), his HGB was low at 11.6 g/dL (reference range 13.0-17.0
g/dL), and his hematocrit was low at 35.9% (reference range 38.8-50.0%). (Id. at 420.)
Based on these labs, petitioner’s doctor expressed concern that he was developing an
infection. (Id. at 406.) Petitioner underwent an MRI of his foot that found no evidence
of osteomyelitis or abscess; however, it did find cellulitis. (Id. at 426-27, 436-38.)
Petitioner saw Dr. Michaels for another follow up appointment on March 15, 2019. (Id.
at 464-73.) Dr. Michaels noted that petitioner’s ulcer had healed. (Id. at 467.)
Petitioner had two more follow up appointments regarding his foot: one on March 22,
2019, and the other on March 29, 2019. (Id. at 502-11, 525-34.) Petitioner’s foot
remained healed. (Id.)
b. As reflected in petitioner’s testimony
In addition to submitting two written statements, petitioner testified at a fact
hearing on August 25, 2022. (ECF Nos. 59-60; Exs. 1, 4.) He noted that prior to
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September 2017, he had never experienced facial paralysis. (Tr. 8.) Though he
experienced a gap in treatment from 2014 to 2017, he explained that prior to his
vaccination, he had been seeking treatment for diabetes and peripheral neuropathy and
saw a doctor regularly. (Id. at 9, 34.) Additionally, petitioner testified that he injured his
left eye when he was six years old. (Id. at 9-10, 52.) This injury has affected his vision
in that eye. (Id. at 10.) Petitioner also had a toe infection, which petitioner claimed was
due to running, but is also a symptom of diabetes. (Id. at 33, 47-48, 53-56.) In 2017,
petitioner was also diagnosed with hypertension. (Id. at 35.)
Petitioner explained that he did not seek treatment from September 2014 through
July of 2017. (Tr. 11.) He was unemployed during those years and he could not afford
to see a doctor. (Id.) During this time, petitioner explained that he managed his
diabetes through diet and exercise and monitored his blood sugar using a monitor and
urinary strips. (Id. at 12, 39-41.) However, when we went to the doctor, his A1C was
still high and noted that his diabetes was not under control until he began seeing a
doctor in 2017. (Id. at 12, 39.)
Petitioner testified that he received the flu and hep B vaccines on September 19,
2017. (Tr. 13.) He testified that he did not notice anything different until around
October 19, 2017, when he “woke up that morning and [his] face was twisted.” (Id. at
13, 50.) He explained that, at that time, he believed he was having a stroke and went to
the emergency room. (Id. at 13.) In the emergency room, petitioner was diagnosed
with Bell’s palsy and was prescribed prednisone and acyclovir. (Id. at 14-15.) However,
his primary care physician decreased his prednisone because it impacted his blood
pressure and blood sugar. (Id.) At this time, petitioner was taking Lisinopril to help with
his blood pressure and kidneys and was only monitoring his glucose levels “to a
degree.” (Id. at 15, 51.)
Petitioner noted that even when he was able to take prednisone and acyclovir, he
was still experiencing symptoms of his Bell’s palsy. (Tr. 15.) He explained that his
symptoms included problems speaking, twisted facial features, light sensitivity, hearing
issues, and a tingling sensation on the left side of his face. (Id. at 16.) Additionally,
petitioner explained that his eye does not close all the way and he often slurs his words
and drools. (Id. at 17.) He noted that his doctor had recommended surgery on his left
eye. (Id.) He explained that the Bell’s palsy primarily impacted the left side of his face.
(Id.) Petitioner also testified that he experienced severe pain in his abdomen which was
diagnosed as a “neuropathy episode.” (Id. at 20.)
Petitioner testified that the last time he sought treatment for his Bell’s palsy was
July 2018. (Tr. 21-22.) He explained that he had not sought treatment since then
because he was functioning well and the pandemic made it more difficult to seek care.
(Id. at 22.) He testified that he wanted to follow up with a neurologist but the soonest
appointment was for February 2023. (Id.) He explained that he continued to do facial
exercises, use ointment on his eye, and massage his face. (Id. at 23.)
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Petitioner testified that his current symptoms include tearing, facial twitching,
sensitivity to sunlight, hearing issues, and drooling. (Tr. 23.) Petitioner testified that he
has to wear sunglasses when he is outside due to his eye sensitivity and goggles in the
shower because he cannot close his eye all the way. (Id. 19-20.) He explained that his
ophthalmologist recommended surgery options to help him close his eye. (Id. at 21.)
Additionally, he testified to how his condition has impacted him psychologically. He
explained that his confidence is low and that it has impacted his personal life as a
mentor through his church. (Id. at 23-24, 27-29.)
Petitioner testified that he discussed the possible causes of his Bell’s palsy with
his treating physicians. (Tr. 25.) He noted that none of his doctors “said exactly what
caused it;” however, he describes three times that his doctors mentioned potential
causes. (Id.) First, he described how the doctors in the emergency room asked if
petitioner had been out of the country or “around any viruses or anyone with a virus.”
(Id.) He explained that he told the doctor that he had not been out of the country, but
had been vaccinated and the doctor had said it was possible those vaccinations could
have caused his Bell’s palsy. (Id.) Second, he described how his first neurologist
explained to him that the type of vaccine he had received was associated with Bell’s
palsy. (Id.) And finally, his second neurologist told him that Bell’s palsy is usually
caused by a virus and tested him for HIV, which came back negative. (Id. at 25-26.) He
noted that his doctors never told him that his diabetes could have caused his Bell’s
palsy. (Id. at 26-27.)
IV. Expert Opinions
a. Petitioner’s Expert, Dr. M. Eric Gershwin, M.D.3
Petitioner’s expert, Dr. M. Eric Gershwin, submitted three expert reports in this
case. (Exs. 7, 63, 69.) In his first report, Dr. Gershwin begins by noting that the
molecular mechanisms of Bell’s palsy “have not been dissected.” (Ex. 7, p. 2.) He goes
on to explain the current state of the mechanistic research and notes that “[t]he
mechanism of Bell’s palsy is thought to be due to an abnormal immune response and
likely has more than [one] mechanism.” (Id. at 5.) One such mechanism, which
according to Dr. Gershwin is most relevant to this case, is a “T cell mediated
inflammatory process, including a localized inflammatory reaction within the facial
nerve.” (Id.) In support of this conclusion, Dr. Gershwin cites two studies that
determined that:
3 Dr. Gershwin received his medical degree from Stanford University. (Ex. 62, p. 1.) He is board certified
in Internal Medicine, Internal Medicine with a subspeciality of Rheumatology, and Allergy and Clinical
Immunology. (Id. at 2.) He is currently a Professor of Medicine in the Division of Rheumatology/Allergy
and Clinical Immunology and Director of the Allergy-Clinical Immunology Program at the University of
California School of Medicine in Davis, California. (Id. at 1.) He has written 69 books and monographs,
938 experimental papers, and 208 book chapters, and he has participated in 38 guest editorials and book
reviews. (Id. at 8-125.)
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[H]istologic changes in the facial nerve can be summarized as follows: 1)
The nerve was infiltrated by small, round inflammatory cells from the internal
acoustic meatus to the stylomastoid foramen. 2) There was a breakdown
of the neuron myelin sheaths that involved the macrophages. 3) There was
an increase in the spaces between the neurons, which was interpreted as
edema. 4) The bony fallopian canal was normal, and there was no sign of
facial nerve compression by the bone of the fallopian canal. The small
round cells of lymphocytic nature and the breakdown of myelin sheaths
probably are the histologic expression of an autoimmune response.
(Id. (quoting A. Greco et al., Bell’s Palsy and Autoimmunity, 12 AUTOIMMUNITY REVS.
323, 325 (2012) (Ex. 38, p. 3) (discus Stephen L. Liston & M. Stephen Kleid,
Histopathology of Bell’s Palsy, 99 LARYNGOSCOPE 23, 24 (1989) (Ex. 39, p. 3))).)
Dr. Gershwin cites several studies that suggest “[a] cell-mediated autoimmune
mechanism has been suggested as the pathogenesis of Bell’s palsy.” (Ex. 7, p. 5 (citing
O. Abramsky et al., Cellular Immune Response to Peripheral Nerve Basic Protein in
Idiopathic Facial Paralysis (Bell’s Palsy), 26 J. NEUROLOGICAL SCIS. 13 (1975) (Ex. 40);
Francis H. McGovern et al., Immunological Concept for Bell’s Palsy: Further
Experimental Study, 86 ANNALS OTOLOGY RHINOLOGY & LARYNGOLOGY 300 (1977) (Ex.
41); P. S. J. Z. Mulkens et al., Acute Facial Paralysis: A Virological Study, 5 CLINICAL
OTOLARYNGOLOGY 303 (1980) (Ex. 42)).) Specifically, Dr. Gershwin notes that a clinical
study found “some alterations in the lymphocyte subsets of the peripheral blood during
the acute stage of” Bell’s palsy. (Id. (citing Aharon Aviel et al., Peripheral Blood T and B
Lymphocyte Subpopulations in Bell’s Palsy, 92 ANNALS OTOLOGY RHINOLOGY &
LARYNGOLOGY 187 (1983) (Ex. 43)).) Yet another study found “cellular and humoral
immunologic alterations” in patients with Bell’s palsy. (Id. (citing M. Mañós-Pujol et al.,
Cellular Immunity Abnormalities in Patients with Recurrent Bell’s Palsy, 12 CLINICAL
OTOLARYNGOLOGY 283 (1987) (Ex. 44)).) Additionally, Dr. Gershwin notes that
“[d]ecreased percentages of total T cells (CD3) and T helper/inducer cells (CD4) have
been documented in the acute phase of disease compared with control patients.” (Id.
(citing Clara Gorodezky et al., The HLA System and T-Cell Subsets in Bell’s Palsy, 111
ACTA OTO-LARYNGOLOGICA (STOCKHOLM) 1070 (1991) (Ex. 45)).)
Dr. Gershwin also notes that there is an association between facial paralysis and
Guillain-Barré syndrome (GBS), a “cell mediated, autoimmune neuritis,” which
continues to support the theory that the mechanism that causes Bell’s palsy is immune
mediated. (Ex. 7, p. 6 (citing Donald I. Charous & Bruce I. Saxe, The Landry-Guillain-
Barré Syndrome, 267 NEW ENG. J. MED. 1334 (1962) (Ex. 46); Oded Abramsky et al.,
Cell-Mediated Immunity to Neural Antigens in Idiopathic Polyneuritis and
Myeloradiculitis: Clinical-Immunologic Classification of Several Autoimmune
Demyelinating Disorders, 25 NEUROLOGY 1154 (1975) (Ex. 47)).) Dr. Gershwin explains
that patients with Bell’s palsy and GBS have been shown to respond to a human basic
protein (P1L) of peripheral nerve myelin. (Id. (citing Abramsky et al., supra, at Ex. 40;
Christian A. Vedeler et al., Antibodies to Peripheral Nerve Tissue in Sera from Patients
with Acute Guillain-Barré Syndrome Demonstrated by a Mixed Haemagglutination
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Technique, 2 J. NEUROIMMUNOLOGY 209 (1982) (Ex. 48)).) Additionally, Dr. Gershwin
notes that patients with Bell’s palsy and GBS had decreased T lymphocytes, specifically
T suppressor cells. (Id. (citing Christian A. Vedeler et al., Immunoglobulins,
Complement Components and Lymphocyte Subpopulations in Bell’s Palsy, 25 EUR.
NEUROLOGY 177 (1986) (Ex. 49); H. Nyland & A. Næss, Lymphocyte Subpopulations in
Blood and Cerebrospinal Fluid from Patients with Acute Guillain-Barré Syndrome, 17
EUR. NEUROLOGY 247 (1978) (Ex. 50); R. A. C. Hughes et al., Lymphocyte
Subpopulations and Suppressor Cell Activity in Acute Polyradiculoneuritis (Guillain-
Barré Syndrome), 51 CLINICAL EXPERIMENTAL IMMUNOLOGY 448 (1983) (Ex. 51); Aviel et
al., supra, at Ex. 43)).) Dr. Gershwin also notes that “similar changes in peripheral
blood lymphocyte subpopulations were also described in the course of several
demyelinating diseases, such as in acute exacerbations of multiple sclerosis and during
the acute stage of [GBS].” (Id. (citing Mulkens et al., supra, at Ex. 42; Nyland & Næss,
supra, at Ex. 50; R. P. Lisak et al., T and B Lymphocytes in Multiple Sclerosis, 22
CLINICAL EXPERIMENTAL IMMUNOLOGY 30 (1975) (Ex. 52)).) Based on these similarities,
Dr. Gershwin concludes that GBS and Bell’s palsy “may share a similar etiology and
pathogenesis,” and even notes that, in some cases, Bell’s palsy is considered “a
mononeuritic variant of [GBS],” or alternatively a polyneuropathy specific to the cranial
nerves. (Id. (citing Aviel et al., supra, at Ex. 43; J. Chaco, Subclinical Peripheral Nerve
Involvement in Unilateral Bell’s Palsy, 52 AM. J. PHYSICAL MED. 195 (1973) (Ex. 53);
Kedar K. Adour et al., The True Nature of Bell’s Palsy: Analysis of 1,000 Consecutive
Patients, 88 LARYNGOSCOPE 787 (1978) (Ex. 12); Leslie P. Weiner et al., Medical
Progress: Viral Infections and Demyelinating Diseases, 288 NEW ENG. J. MED. 1103
(1973) (Ex. 54); Peter W. Lampert, Autoimmune and Virus-Induced Demyelinating
Diseases: A Review, 91 AM. J. PATHOLOGY 176 (1978) (Ex. 55)).) Nonetheless, Dr.
Gershwin acknowledges that “Bell’s palsy is a clinical syndrome, and it is entirely
possible that more than one disease entity can produce an idiopathic facial palsy.” (Id.
at 5.)
In addition to the similarities between Bell’s palsy and GBS, Dr. Gershwin also
relies on the fact that “viruses and immune mechanisms involvement have also been
proposed in Bell’s palsy,” which he notes supports the theory that it is caused by “an
autoimmune postviral disease.” (Ex. 7, p. 6 (citing Abramsky et al., supra, at Ex. 40).)
Dr. Gershwin explains that the mechanism leading to this potential causal association is
not clear. (Id. (citing Aviel et al., supra, at Ex. 43).) However, he then explains some
potential theories that have been considered. (Id. at 6-7.) Specifically, Dr. Gershwin
notes that patients with Bell’s palsy have “elevated concentrations of the cytokines
interleukin-1 (IL-1), IL-6, and tumor necrosis factor-alpha (TNF-alpha),” which,
according to Dr. Gershwin, is evidence of an activation of cell-mediated effectors. (Id. at
6 (citing Mustafa Yilmaz et al., Serum Cytokine Levels in Bell’s Palsy, 197 J.
NEUROLOGICAL SCIS. 69 (2002) (Ex. 57)).) Dr. Gershwin supports this conclusion by
noting that some studies have “proposed that a breakdown of peripheral tolerance
occurred in patients with hepatitis C virus infection as a consequence of interferon
(IFN)-alpha therapy.” (Id. at 6-7 (citing Matthew Hoare et al., Bell’s Palsy Associated
with IFN-α and Ribavirin Therapy for Hepatitis C Virus Infection, 25 J. INTERFERON &
CYTOKINE RSCH. 174 (2005) (Ex. 58)).) Dr. Gershwin suggests these issues exist in the
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myelin sheath because most patients with Bell’s palsy do recover quickly. (Id. at 7
(citing Abramsky et al., supra, Ex. 40).)
Dr. Gershwin posits that the evidence that Bell’s palsy is cell-mediated and its
association with viruses is also evidence that Bell’s palsy can be caused by vaccines.
(Ex. 7, pp. 2-3, 7.) Specifically, Dr. Gershwin notes that “[i]ntranasal administration of
influenza vaccines may reduce the transmission of influenza more efficiently than
parenteral administration because it stimulates both mucosal and systemic immune
responses.” (Id. at 7 (citing Edel A. McNeela & Kingston H.G. Mills, Manipulating the
Immune System: Humoral Versus Cell-Mediated Immunity, 51 ADVANCED DRUG
DELIVERY REVS. 43 (2001) (Ex. 61)).) In support of this conclusion, Dr. Gershwin
submitted several case studies, reports, and research studies. (Id. at 2-3 (citing
Barbara Rath et al., “All that Palsies is not Bell’s [1]” – The Need to Define Bell’s Palsy
as an Adverse Event Following Immunization, 26 VACCINE 1 (2007) (Ex. 13)
(comprehensive literature review regarding classifying Bell’s palsy as an adverse event
following immunization, which specifically notes that Bell’s palsy has been studied
following various vaccines); Margot Mutsch et al., Use of the Inactivated Intranasal
Influenza Vaccine and the Risk of Bell’s Palsy in Switzerland, 350 NEW ENG. J. MED. 896
(2004) (Ex. 15) (case-control study and a case-series analysis finding that there is a
“strong association between the inactivated intranasal influenza vaccine used in
Switzerland and Bell’s palsy,” however, this vaccine is no longer used); Weigong Zhou
et al., A Potential Signal of Bell’s Palsy After Parenteral Inactivated Influenza Vaccines:
Reports to the Vaccine Adverse Event Reporting System (VAERS)—United States,
1991-2001, 13 PHARMACOEPIDEMIOLOGY & DRUG SAFETY 505 (2004) (Ex. 16) (study
revealing a “possible association between influenza vaccines and an increased risk of
Bell’s palsy”)).)4
Dr. Gershwin also acknowledges the association between diabetes and Bell’s
palsy. (Ex. 7, pp. 3-4.) He notes that “approximately 5-10% of patients” with Bell’s
palsy also have diabetes. (Id. at 2 (citing Raymond L. Hilsinger, Jr. & Kedar Karim
Adour, Idiopathic Facial Paralysis, Pregnancy, and the Menstrual Cycle, 84 ANNALS OF
OTOLOGY RHINOLOGY & LARYNGOLOGY 433 (1975) (Ex. 8); Mark May & Susan R. Klein,
4 However, Dr. Gershwin acknowledges that some studies have found no association between
vaccination and Bell’s palsy. (Ex. 7, pp. 2-3 (citing Leonoor Wijnans et al., Bell’s Palsy and Influenza
(H1N1)pdm09 Containing Vaccines: A Self-Controlled Case Series, 12 PLOS ONE 1 (2017) (Ex. 20)
(finding “no evidence of increased incidence of Bell’s palsy following seasonal influenza vaccination
overall, nor for monovalent pandemic influenza vaccine in 2009); Ali Rowhani-Rahbar et al., Immunization
and Bell’s Palsy in Children: A Case-Centered Analysis, 175 AM. J. EPIDEMIOLOGY 878 (2012) (Ex. 14)
(finding no association between immunization and Bell’s palsy in children); Sharon K. Greene et al., Near
Real-Time Surveillance for Influenza Vaccine Safety: Proof-of-Concept in the Vaccine Safety Datalink
Project, 171 AM. J. EPIDEMIOLOGY 177 (2010) (Ex. 17) (study looking at several adverse events associated
with vaccination and not finding a statistically significant relationship between seasonal trivalent
inactivated influenza vaccine and Bell’s palsy); Julia Stowe et al., Bell’s Palsy and Parental Inactivate
Influenza Vaccine, 2 HUM. VACCINES 110 (2006) (Ex. 18) (study found “no evidence of an increased risk of
Bell’s palsy in the three months following parenteral inactivated influenza vaccine”). But see Samuel
Shapiro, Invited Commentary: Immunization and Bell’s Palsy in Children, 175 AM. J. EPIDEMIOLOGY 886
(2012) (Ex. 19) (identifying some issues with how the study in Ex. 18 was conducted)).)
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Differential Diagnosis of Facial Nerve Palsy, 24 OTOLARYNGOLOGIC CLINICS N. AM. 613
(1991) (Ex. 9); Erik Peitersen, The Natural History of Bell’s Palsy, 4 AM. J. OTOLOGY 107
(1982) (Ex. 10); R.E. Mountain et al., The Edinburgh Facial Palsy Clinic: A Review of
Three Years’ Activity, 39 J. ROYAL COLL. SURGEONS EDINBURGH 275 (1994) (Ex. 11);
Adour et al., supra, at Ex. 12).) However, Dr. Gershwin also notes that the magnitude
of the association between diabetes and Bell’s palsy is controversial. (Id. at 3 (citing
Ru-Lan Hsieh et al., Correlates of Degree of Nerve Involvement in Early Bell’s Palsy, 9
BMC NEUROLOGY 1 (2009) (Ex. 21); I.M. Smith et al., Idiopathic Facial (Bell’s) Palsy: A
clinical Survey of Prognostic Factors, 13 CLINICAL OTOLARYNGOLOGY 17 (1988) (Ex. 22);
Luzy Abraham-Inpijn & Pieter P. Devriese, Hypertension and Diabetes Mellitus in Bell’s
Palsy, in DISORDERS OF THE FACIAL NERVE: ANATOMY, DIAGNOSIS, AND MANAGEMENT 251
(Malcomn D. Graham & William F House eds., 1982) (Ex. 23); Akira Takahashi & Itsuro
Sobue, Concurrence of Facial Paralysis and Diabetes Mellitus: Prevalence, Clinical
Features and Prednisolone Treatment, in DIABETIC NEUROPATHY: CLINICAL MANAGEMENT
173 (Aristidis Veves & Rayaz Malik eds., 2nd ed. 1982) (Ex. 24)).) Specifically, he
quotes a paragraph from a study critical of research that found an association between
Bell’s palsy and diabetes because the literature is older and the studies used tests not
common in clinical practice. (Id. at 3-4 (quoting Maria Riga et al., The Role of Diabetes
Mellitus in the Clinical Presentation and Prognosis of Bell Palsy, 25 J AM. BOARD FAM.
MED. 819, 821-24 (2012) (Ex. 25, pp. 3-6)).)
Instead, Dr. Gershwin opines that petitioner’s diabetes merely left petitioner more
susceptible to Bell’s palsy because “diabetics already have some degree of nerve
ischemia.” (Ex. 7, p. 4 (citing Riga et al., supra, at Ex. 25).) Dr. Gershwin opines that
after petitioner received his vaccination, he “develop[ed] immune response as expected
from any vaccination,” and that, “[i]n the absence of any other etiological events that can
be associated with Bell’s palsy, [petitioner] would have a localized T cell mediated
inflammatory response based upon a molecular mimicry with either the influenza or the
hepatitis B vaccine.” (Id. at 7.) He concludes that, instead of causing his Bell’s palsy,
petitioner’s diabetes instead “suggests that his facial nerve was already damaged from
his diabetic neuropathy and therefore any further inflammatory response would
compromise the nerve further.” (Id.)
In his second report, Dr. Gershwin addresses the etiology of Bell’s palsy and
goes into further detail regarding the T cell reaction caused by petitioner’s vaccination
and the temporal association between petitioner’s vaccination and development of Bell’s
palsy. (Ex. 63.) First, Dr. Gershwin notes that the etiology of Bell’s palsy has been
summarized as: (1) anatomical structure, (2) viral infections, (3) ischemia, (4) immune
inflammatory, and (5) acute cold exposure. (Id. at 1 (citing Wenjuan Zhang et al., The
Etiology of Bell’s Palsy: A Review, 267 J. NEUROLOGY 1896 (2020) (Ex. 64)).) He notes
that the authors of that study additionally point out that the clinical and immunological
data “‘suggests activation of cell-mediated effectors and the involvement of immune
mechanisms in Bell’s palsy.’” (Id. (quoting Zhang et al., supra, at Ex. 64, p. 6).)
Additionally, Dr. Gershwin notes that petitioner developed Bell’s palsy “within a month of
vaccination,” which “is consistent with the production of T cell immunity after influenza
vaccination.” (Id. at 2 (citing Tina Schmidt et al., CD4+ T-Cell Immunity After Pandemic
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Influenza Vaccination Cross-Reacts with Seasonal Antigens and Functionally Differs
from Active Influenza Infection, 42 EUR. J. IMMUNOLOGY 1755 (2012) (Ex. 66) (finding
increases in T cell production up to 10 weeks post-vaccination with influenza); Ulrik
Stervbo et al., Age Dependent Differences in the Kinetics of ỿδ T Cells After Influenza
Vaccination, 12 PLOS ONE 1 (2017) (Ex. 67)).) Dr. Gershwin notes that there is a
similar timeline for an immunological response to the hep B vaccine. (Id. (citing I.
Desombere et al., Characterization of the T Cell Recognition of Hepatitis B Surface
Antigen (HBsAg) by Good and Poor Responders to Hepatitis B Vaccines, 122 CLINICAL
& EXPERIMENTAL IMMUNOLOGY 390 (2000) (Ex. 68)).) Dr. Gershwin acknowledges that
petitioner “has had diabetes for more than a decade;” however, he notes that petitioner
did not develop Bell’s palsy until after he was vaccinated. (Id.) Dr. Gershwin concluded
that “[t]he acute T cell-mediated immunity expected after his seasonal influenza and
second Hepatitis B vaccination was the final insult that led to further ischemic changes
and his development of Bell’s palsy.” (Id.)
In his third report, Dr. Gershwin addresses whether, in his opinion, petitioner’s
Bell’s palsy was a result of his diabetes alone. (Ex. 69.) For this report, Dr. Gershwin
reviewed a study, which found that “‘[a]ll the clinical and immunological data . . .
suggests activation of cell-mediated effectors and the involvement of immune
mechanisms in Bell’s palsy.’” (Id. (quoting Zhang et al., supra, at Ex. 64, p. 6).)
Additionally, Dr. Gershwin notes that “[n]ot all studies have demonstrated an association
of diabetes and Bell’s palsy,” and “[t]he relationship between Bell’s [p]alsy and diabetes
is not clearly related to diabetes control (hyperglycemia) and they suggest further
studies are warranted.” (Id. (citing Riga et al., supra, at Ex. 25).)
b. Respondent’s Expert, Dr. Thomas P. Leist, M.D., Ph.D.5
Respondent’s expert, Dr. Thomas P. Leist, submitted two reports in this case.
(Exs. A; C.) In his first report, Dr. Leist opined that “diabetes related microvascular
injury is the likely cause of [petitioner’s] Bell’s palsy.” (Ex. A, p. 5.) In support of this
opinion, Dr. Leist cites a study done by Pecket and Schattner, which found that “‘in a
series of 126 patients with Bell’s palsy, chemical or overt diabetes was found in 39% of
cases.’” (Id. (quoting P. Pecket & A. Schattner, Concurrent Bell’s Palsy and Diabetes
Mellitus: A Diabetic Mononeuropathy?, 45 J. NEUROLOGY NEUROSURGERY & PSYCHIATRY
652 (1982) (Ex. A, Tab 2)).) In another study of 684 patients with Bell’s palsy, 11.4%
had diabetes. (Id. (citing Kedar K. Adour et al., Prevalence of Concurrent Diabetes
Mellitus and Idiopathic Facial Paralysis (Bell’s Palsy), 24 DIABETES 449 (1975) (Ex. A,
Tab 1)).) Additionally, relying on one of the studies cited by Dr. Gershwin, Dr. Leist
explains that “‘Bell’s palsy is considered to be an entrapment neuropathy resulting from
inflammation, edema, and strangulation. Diabetes, hypertension, and
5 Dr. Leist is board certified in Psychiatry and Neurology. (Ex. B, p. 1.) He received his medical degree
from the University of Miami and his Ph.D. in Biochemistry from the University of Zurich. (Id.) He
currently works as a Professor of Neurology at Thomas Jefferson University, Chief of the Division of
Clinical Neuroimmunology and Director of the Comprehensive Multiple Sclerosis Center, a neurology
consultant at the Inglis Foundation, and Director of Hospital-Based Neurology Infusion Service. (Id.) He
has published 61 peer-reviewed papers, 12 review and invited publications, editorials, commentaries, and
book chapters, and participated in 47 clinical trials. (Id. at 5-14.)
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hypercholesterolemia have all been related to microangiopathies.’” (Id. (quoting Riga et
al., supra, at Ex. 25, p. 1).)
Dr. Leist notes that petitioner’s diabetes was “poorly controlled from at least
2007.” (Ex. A, p. 4.) Additionally, Dr. Leist opines that “[t]here was clinical evidence
microvascular/microcirculatory compromise in [petitioner’s] case prior to the
administration of vaccines on September 19, 2017.” (Id. at 5.) Dr. Leist opines that
these “preexisting microvascular/microcirculatory compromise included diabetic
neuropathy indicative of microvascular compromise/microvascular injury of the
peripheral nerves, diabetic retinopathy and macular edema suggestive of microvascular
changes/injury in the eyes, microalbuminuria – suggesting microvascular injury in the
kidneys, and skin ulcers indicating peripheral vascular compromise.” (Id.) Additionally,
Dr. Leist noted that “elevated hemoglobin A1c values correlated significantly with severe
Bell’s palsy.” (Id. (citing Riga et al., supra, at Ex. 25).) Therefore, Dr. Leist opines “that
association between Bell’s palsy and diabetes and severity of Bell’s palsy and elevated
hemoglobin A1c is well established.” (Id.)
Finally, Dr. Leist rejects the opinion that vaccines can cause Bell’s palsy. (Ex. A,
p. 5.) He noted that “[t]he Institute of Medicine has reviewed the question of an
association of inactivated influenza vaccine and Bell’s palsy and concluded that the
evidence favored rejection of a causal relationship.” (Id. (citing IOM Report 2012 (Ex. A,
Tab 4)).)
In his second report, Dr. Leist reiterates his opinion that “[t]he association of
diabetes and Bell’s palsy is well documented.” (Ex. C, p. 1 (citing Pecket & Schattner,
supra, at Ex. A, Tab 2; Adour et al., supra, at Ex. A, Tab 1).) Dr. Liest further quotes an
article by Zhang et al, which states that “in certain clinical conditions, such as diabetes
mellitus, primary ischemic neuropathy is likely to occur,” and “after transient ischemia
and reperfusion, acute inflammation of the diabetic nerve is seen.” (Id. (quoting Zhang
et al., supra, Ex. 64, p. 5.) Dr. Leist notes that Dr. Gershwin acknowledged this when
he admitted that petitioner’s diabetes left him more susceptible to Bell’s palsy. (Id. at 2
(citing Ex. 63, p. 2).)
Additionally, Dr. Leist opines that “Dr. Gershwin does not provide any evidence
that influenza vaccine causes inflammation essentially restricted to the facial nerve and
does not explain why the two-step process of injury he proposes as having occurred is
the more likely cause of Bell’s palsy in [petitioner’s] case than poorly controlled diabetes
alone.” (Ex. C, p. 2.) Dr. Leist acknowledges that diabetes can lead to inflammation in
the facial nerve; however, he noted that “Dr. Gershwin does not provide any insights
how to distinguish reactive inflammation of the facial [nerve] following transient ischemia
due to diabetes . . . from vaccine induced inflammation of the facial nerve which he
alleges occurred but for which he has not provided any evidence.” (Id. (citing Zhang et
al., supra, at Ex. 64).)
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V. Discussion
a. Althen prongs one and three
Under Althen prong one, petitioners must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford,
451 F.3d at 1355-56 (quoting Pafford v. Sec’y of Health & Human Servs., No. 01-
0165V, 2004WL 171359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19
(2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006)). Scientific evidence offered to establish
Althen prong one is viewed “not through the lens of the laboratorian, but instead from
the vantage point of the Vaccine Act’s preponderant evidence standard.” Andreu ex rel.
Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009). In
this case, petitioner relies on Dr. Gershwin’s assertion that his Bell’s palsy was caused
by “a localized T cell mediated inflammatory response based upon a molecular mimicry
with either the influenza or the hepatitis B vaccine.” (ECF No. 64, p. 6 (citing Ex. 7, p.
7); ECF No. 66, p. 1.) According to Dr. Gershwin, this immune reaction caused
inflammation in the facial nerve, which led to paralysis of the facial muscles. (ECF No.
64, pp. 6-7 (citing Ex. 7, pp. 1-2, 5).)
The third Althen prong requires establishing a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1278. A petitioner
must offer “preponderant proof that the onset of symptoms occurred within a timeframe
for which, given the medical understanding of the disorder’s etiology, it is medically
acceptable to infer causation-in-fact.” de Bazan, 539 F.3d at 1352. Petitioner contends
that he “developed Bell’s palsy within a month of vaccination,” which “is consistent with
the production of T cell immunity after influenza vaccination.” (ECF No. 64, p. 10 (citing
Ex. 63, p. 2 (relying on Schmidt et al., supra, at Ex. 66)).) Petitioner relied on Dr.
Gershwin’s assertion that “T cells are activated after a flu vaccination within 3.5 weeks,”
and that similar data exists for the hep B vaccine. (Id. (citing Ex. 63 (relying on Exs. 66-
68).) Therefore, petitioner notes that he developed Bell’s palsy within 3.5 weeks
following vaccination, “which is within the period expected given the proposed
mechanism.” (Id.)
Petitioner argues that respondent has not actually challenged his showing with
respect to either Althen prongs one or three. (ECF No. 66, pp. 1-2, 4.) This is not
accurate. (See ECF No. 65.) However, the analysis below does confirm that
petitioner’s claim fails under Althen prong two regardless of the outcome of prongs one
or three. Accordingly, in the interest of brevity, this decision will assume, but not decide,
that petitioner has satisfied Althen prongs one and three in order to reach the dispositive
issues in this case relating to whether there is a logical sequence of cause and effect
implicating petitioner’s vaccination in his own course of Bell’s palsy.6 Accord Winkler v.
6 Though not resolving Althen prongs one and three in this case, I do note that another special master
has determined that there are reputable medical theories supporting the conclusion that the flu vaccine
and the hep B vaccine can cause Bell’s palsy up to 40 days post-vaccination depending on the theory
proffered. E.g., Sturdevant v. Sec’y of Health & Human Servs., No. 17-172V, 2022 WL 3369716 (Fed. Cl.
Spec. Mstr. July 19, 2022); Beraki v. Sec’y of Health & Human Servs., No. 17-243V, 2021 WL 4891119
(Fed. Cl. Spec. Mstr. Sept. 20, 2021); E.A. v. Sec’y of Health & Human Servs., No. 18-1587V, 2023 WL
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Sec’y of Health & Human Servs., No. 18-203V, 2021 WL 6276203, at *23 (Fed. Cl.
Spec. Mstr. Dec. 10, 2021) (citing Vaughan ex rel. A.H. v. Sec’y of Health & Human
Servs., 107 Fed. Cl. 212, 221-22 (2012); Hibbard v. Sec’y of Health & Human Servs.,
698 F.3d 1355, 1364 (Fed. Cir. 2012)), aff’d, 88 F.4th 958 (Fed. Cir. 2023) (finding no
abuse of discretion where the special master “assumed” Althen prong one was met
before concluding Althen prong two was dispositive).
b. Althen prong two
The second Althen prong requires proof of a logical sequence of cause and
effect, usually supported by facts derived from a petitioner’s medical records. Althen,
418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano v. Sec’y of Health & Human
Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006); Grant, 956 F.2d at 1148. Medical records
are generally viewed as particularly trustworthy evidence. Cucuras v. Sec’y of Health &
Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records and/or
statements of a treating physician’s views do not per se bind the special master. See
§ 300aa-13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment, test result,
report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y
of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“[T]here is nothing . . . that
mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted.”). A petitioner may support a cause-in-
fact claim through either medical records or expert medical opinion. § 300aa-13(a).
The special master is required to consider all the relevant evidence of record, draw
plausible inferences, and articulate a rational basis for the decision. Winkler, 88 F.4th at
963 (citing Hines, 940 F.2d at 1528). Petitioner need not prove his vaccination was the
sole cause of his injury, but he must show that it was a substantial contributing factor
and a “but for” cause. Shyface, 165 F.3d at 1352. Although petitioners do not bear a
burden of eliminating other causes of injury, evidence of other possible sources of injury
can be relevant to determining whether a prima facie showing has been made as to
vaccine causation. Winkler, 88 F.4th at 963 (citing Stone v. Sec’y of Health & Human
Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012).)
On petitioner’s behalf, Dr. Gershwin presents a “cell-mediated immune response
following vaccination” as the “final insult” that “further compromised [petitioner]’s
ischemia” and led to his Bell’s palsy. (Ex. 63, p. 2; Ex. 69, p. 1.) Dr. Gershwin’s search
for an inciting immune event may be a natural extension of his own proposed theory of
causation, however, he acknowledges that his theory is only one possible etiologic
explanation for Bell’s palsy. He explains that studies are lacking that “would help define
the mechanisms” of injury in Bell’s palsy and that it “likely has more than [one]
mechanism.” (Ex. 7, pp. 2, 5.) He specifically states that “Bell’s palsy is a clinical
syndrome, and it is entirely possible that more than one disease entity can produce an
idiopathic facial palsy.” (Id. at 5.) He explains that while the “key evidence” for the
etiology of Bell’s palsy includes immune inflammation, it also includes anatomical
structures, viral infections, acute cold exposure, and, importantly, ischemia. (Ex. 63, p.
2640710 (Fed. Cl. Spec. Mstr. Jan. 24, 2023); Arredondo v. Sec’y of Health & Human Servs., No. 18-
1782V, 2023 WL 8181138 (Fed. Cl. Spec. Mstr. Oct. 31, 2023).
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1.) Dr. Gershwin posits that there are no other “etiological events” that could explain
petitioner’s condition. (Ex. 7, p. 7.) However, he contradicts himself by acknowledging
that “facial nerves get their vascular supply by a multitude of vessels and when they are
obstructed, it will lead to ischemia. Since patients with diabetes may already have
nerve ischemia, the pre-existing microangiopathy may facilitate the natural history of
Bell’s palsy.” (Id. at 4.) Further to this, Dr. Gershwin agrees that petitioner “has chronic
insulin-dependent Type II diabetes, and has a previous history of polyneuropathies
secondary to the vascular/ischemia associated with diabetes.” (Ex. 69, p. 1.) Dr.
Gershwin explicitly opines that petitioner “was already compromised based upon his
underlying ischemia from the diabetes.” (Ex. 63, p. 2.)
Thus, both parties’ experts opine that petitioner’s diabetes is at minimum a
significant part of the explanation for petitioner’s Bell’s palsy. Further to which,
respondent’s expert, Dr. Leist, is persuasive in observing that Dr. Gershwin has little to
no basis for additionally invoking an immune mechanism of injury.7 (Ex. A, p. 5; Ex. C,
p. 2.) Dr. Leist correctly explains that on this record “Dr. Gershwin does not provide any
insights how to distinguish reactive inflammation of the facial [nerve] following transient
ischemia due to diabetes, which he opines was present, from vaccine induced
inflammation of the facial nerve which he alleges occurred but for which he has not
provided any evidence.” (Ex. C, p. 2.) In contrast to the lack of any clinical indicators of
injurious post-vaccination inflammation, the medical records very clearly establish not
merely that petitioner had coincidental diabetes, but that his diabetes was not under
control at the time of his Bell’s palsy and that it was otherwise manifesting similar
complications pre-dating the vaccinations at issue. Specifically, Dr. Leist explains that
[t]here was clinical evidence [of] microvascular/microcirculatory
compromise in [petitioner]’s case prior to the administration of vaccines on
September 19, 2017. Preexisting findings that indicated preexisting
microvascular/microcirculatory compromise included diabetic neuropathy
indicative of microvascular compromise/microvascular injury of the
peripheral nerves, diabetic retinopathy and macular edema suggestive of
microvascular changes/injury in the eyes, microalbuminuria – suggesting
7 Petitioner contends that respondent’s expert “does not dispute that [petitioner]’s vaccines caused harm.”
(ECF No. 66, p. 2.) But this is not accurate. Petitioner focuses on the phrasing of the conclusion to Dr.
Leist’s two reports in which he stated that petitioner “did not suffer an enduring injury” as a consequence
of his vaccinations. (Ex. A, p. 6; Ex. C, p. 2.) Petitioner interprets Dr. Leist’s reports as implying that
petitioner may have suffered a short-term harm. (ECF No. 66, pp. 2-3.) While Dr. Leist’s use of the word
“enduring” is a bit confusing, it is apparent when examining his opinion as a whole that Dr. Leist does, in
fact, challenge petitioner’s contention that petitioner suffered any vaccine caused injury at all. In his first
report, Dr. Leist stressed that petitioner “did not report any immediate or delayed side effects of the
vaccinations in the minutes, hours, and days following administration.” (Ex. A, p. 4.) Instead, he stated,
“It is my opinion that diabetes related microvascular injury is the likely cause of [petitioner]’s Bell’s palsy.”
(Id. at 5.) In his second report, Dr. Leist further indicated that “Dr. Gershwin does not provide any
evidence that influenza vaccine causes inflammation essentially restricted to the facial nerve and does
not explain why the two-step process of injury he proposes as having occurred is the more likely cause of
Bell’s palsy in [petitioner]’s case than poorly controlled diabetes alone.” (Ex. C, p. 2.)
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microvascular injury in the kidneys, and skin ulcers indicating peripheral
vascular compromise.
(Ex. A, p. 5.) Dr. Gershwin has not challenged this assessment. In fact,
notwithstanding his search for an additional final straw, Dr. Gershwin agrees not only
that petitioner was suffering diabetes-related ischemia sufficient to induce neurologic
damage but further that the relevant facial nerve was likely already damaged by
petitioner’s diabetes prior to vaccination. (Ex. 7, p. 7 (stating that “[t]he presence of
diabetes in [petitioner] suggests that his facial nerve was already damaged from his
diabetic neuropathy”); Ex. 63, p. 2 (submitting “that he was already compromised based
upon his underlying ischemia from diabetes”).)
Dr. Gershwin opines that all of this left petitioner merely susceptible to Bell’s
palsy and stresses that petitioner’s history of diabetic ischemic polyneuropathy “does
not make [him] immune from a secondary insult.” (Ex. 69, p. 1.) The latter point may be
true as far as it goes, but it is not evidence that a secondary insult is implicated. Apart
from a post-vaccination onset, petitioner has not pointed to any clinical evidence that
supports Dr. Gershwin’s opinion. Even while assuming the onset of petitioner’s Bell’s
palsy could be compatible with Dr. Gershwin’s theory, Dr. Leist is correct to stress that
petitioner did not report any immediate or delayed side effects of the vaccinations in the
days following vaccination. (Ex. A, p. 4.) Especially in the context of petitioner’s
chronic, ongoing, and uncontrolled diabetes, the three-and-a-half week latency in this
case, even if generally plausible under petitioner’s theory, is not compelling on its own
as any kind of clear indicator of vaccine causation.8 Nor does petitioner point to any
medical opinion by any treating physician favoring his assertion of vaccine causation.9
(ECF No. 64, pp. 8-10; ECF No. 66, pp. 2-4.) Moreover, Dr. Leist correctly observes
that Dr. Gershwin “does not explain why the two-step process of injury he proposes as
having occurred is the more likely cause of Bell’s palsy in [petitioner]’s case than poorly
controlled diabetes alone.” 10 (Ex. C, p. 2.)
8 In some cases, post-vaccination Bell’s palsy has been alleged based on an innate immune response
that created an onset occurring within days of vaccination. See, e.g., Sturdevant, 2022 WL 3369716;
Beraki, 2021 WL 4891119. In such cases, it is easier to see how the timing of onset could potentially be
viewed as suspicious for a sequence of cause and effect whereby an acute event led directly, and more
or less immediately, to the Bell’s palsy. But, in any event, the Federal Circuit has explained that
“[a]lthough probative, neither a mere showing of a proximate temporal relationship between vaccination
and injury, nor a simplistic elimination of other potential causes of the injury suffices, without more, to
meet the burden of showing actual causation.” Althen, 418 F.3d at 1278 (citing Grant, 956 F.2d at 1149).
9 Though petitioner testified that his doctors discussed the possibility of vaccine causation with him (Tr.
25-27), this is not reflected in any of his medical records. In any event, petitioner confirmed in his
testimony that none of his physicians actually concluded his Bell’s palsy was vaccine caused,
acknowledging that none of his doctors “said exactly what caused it.” (Id. at 25.)
10 Though the idea of an immune trigger may be consistent with Dr. Gershwin’s theory, his assertion of
that trigger in this specific case, based on no clinical evidence apart from petitioner’s very manifestation of
the allegedly vaccine-caused injury, amounts to a circular logic that has been rejected in prior cases.
Accord Dodd v. Sec’y of Health & Human Servs., No. 09-0585V, 2013 WL 3233210, at *14 (Fed. Cl.
Spec. Mstr. June 5, 2013) (explaining that “Dr. Kinsbourne’s circular logic, that one event was caused by
another simply because the second event occurred, is also unavailing”), aff’d, 114 Fed. Cl. 43 (2013);
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Even granting petitioner the assumption that he has satisfied Althen prongs one
and three, the Federal Circuit has cautioned that the second Althen prong “is not without
meaning.” Capizzano, 440 F.3d at 1327. Satisfying Althen prongs one and three
generally serves largely as a threshold demonstration that a petitioner’s claim is even
possible. The Court explained that
[t]here may well be a circumstance where it is found that a vaccine can
cause the injury at issue and where the injury was temporally proximate to
the vaccination, but it is illogical to conclude that the injury was actually
caused by the vaccine. A claimant could satisfy the first and third prongs
without satisfying the second prong when medical records and medical
opinions do not suggest that the vaccine caused the injury, or where the
probability of coincidence or another cause prevents the claimant from
proving that the vaccine caused the injury by preponderant evidence.
Id.
That is precisely the scenario presented in this case. Given the lack of either
treating physician support or meaningful clinical evidence and the undisputed presence
of uncontrolled diabetes, Dr. Gershwin’s mere ipse dixit assertion that petitioner’s
vaccination was a factor additional to his diabetes in bringing about his own Bell’s palsy
does not carry petitioner’s burden of proof under Althen prong two. Moreover, Dr.
Gershwin’s own concessions regarding the important role of diabetes in bringing about
petitioner’s own injury dramatically undercut the assertion. This is not a question of
petitioner disproving any role for his diabetes in causing his injury. As explained above,
petitioner need not show his vaccination to have been the sole cause of his injury.
Shyface, 165 F.3d at 1352. Instead, Dr. Gershwin’s opinion is inadequate to
preponderantly demonstrate that petitioner’s vaccinations played any role, as a
substantial contributing factor or a but for cause additional to his diabetes, in the
development of his Bell’s palsy.
c. Factor unrelated to vaccination
In this case, both parties addressed their arguments to the question of whether
petitioner has met his burden of proof under the Althen test in the face of respondent’s
opposition, which is based primarily on diabetes as the cause of petitioner’s condition.
(ECF Nos. 64-65.) Importantly, however, as noted above, petitioner is not obligated as
part of his prima facie burden of proof to eliminate alternative causes of his condition.
de Bazan, 539 F.3d at 1352-53; Winkler, 88 F.4th at 962-63. Instead, once a petitioner
has satisfied his own burden pursuant to the Althen test, the burden shifts to respondent
Morgan v. Sec’y of Health & Human Servs., No. 12-77V, 2017 WL 6893079, at *22 (Fed. Cl. Spec. Mstr.
Dec. 6, 2017) (concluding, “Petitioner’s experts assumed that the very fact she experienced a rare injury
at all was circumstantial proof of her ‘unique genetic repertoire.’ This kind of circular logic (the injury is
itself proof of causation) does not meet the preponderant evidentiary standard set for a vaccine injury
claim.” (internal citation omitted)).
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to demonstrate that his injury was caused by factors unrelated to vaccination. § 300aa-
13(a)(1)(B); Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363, 1367 (Fed.
Cir. 2013).
Consistent with the parties’ framing of the issue, I have concluded that petitioner
did not meet his burden of proof under Althen for the reasons discussed above. Accord
Winkler, 88 F.4th at 962 (quoting Doe v. Sec’y of Health & Human Servs., 601 F.3d
1349, 1356-58 (Fed. Cir. 2010), for the proposition that “a ‘petitioner’s failure to meet his
burden of proof as to the cause of an injury or condition is different from a requirement
that he affirmatively disprove an alternative cause”). However, in the interest of
completeness, I additionally note that, even assuming arguendo that petitioner did meet
his initial burden under Althen, I would still conclude that respondent has put forward
sufficient evidence to preponderantly demonstrate that petitioner’s Bell’s palsy was
more likely than not caused by his diabetes, rather than his vaccination(s). Although
respondent has argued that the burden of proof never shifted to him, he is clear in
contending that his expert has established diabetes as a more likely cause of
petitioner’s Bell’s palsy to the exclusion of his vaccinations. (ECF No. 65, p. 32; ECF
No. 38, p. 14.)
In order to meet his shifted burden of proof, respondent must demonstrate by
preponderant evidence “that a particular agent or condition (or multiple
agents/conditions) unrelated to the vaccine was in fact the sole cause (thus excluding
the vaccine as a substantial factor).” de Bazan, 539 F.3d at 1354 (emphasis omitted).
As with petitioner’s burden under Althen, respondent must show a logical sequence of
cause and effect linking the injury to the proposed factor unrelated. Deribeaux, 717
F.3d at 1368-69. It need not be scientifically certain but must be legally probable. Id.
Conditions or other factors that are “idiopathic, unexplained, unknown, hypothetical, or
undocumentable” cannot defeat a petitioner’s claim. § 300aa-13(a)(2); Knudsen ex rel.
Knudsen, 35 F.3d 543, 548 (Fed. Cir. 1994).
First, there is no meaningful dispute in this case that diabetes can cause Bell’s
palsy. Both parties’ experts agree that the medical literature supports an association
between diabetes and Bell’s palsy, even as petitioner’s expert, Dr. Gershwin, cautions
that the magnitude of the association is unsettled. (Ex. A, p. 5; Ex .7, pp. 3-4.) Despite
cautioning that not all available studies have confirmed an association between
diabetes and Bell’s palsy (Ex. 69, p. 1), Dr. Gershwin agrees on petitioner’s behalf that
“the role of diabetes in the development of Bell’s palsy is well known” (Ex. 7, p. 3).
Respondent’s expert, Dr. Leist, further explains that Bell’s palsy is an entrapment
neuropathy that can result from, inter alia, primary ischemic neuropathy due to diabetes.
(Ex. A, p. 5; Ex. C, p. 1.) Dr. Gershwin does not disagree. (Ex. 7, p. 4; Ex. 63, p. 1.)
Although Dr. Gershwin asserts on petitioner’s behalf that Bell’s palsy can also have an
immune etiology, he acknowledges that there are likely multiple pathophysiologic
pathways and multiple disease entities that lead to Bell’s palsy and/or facial paralysis.
(Ex. 7, p. 5.) Consistent with Dr. Leist’s opinion, he further agrees that diabetes-related
ischemia can cause nerve damage, including damage to the nerve implicated in Bell’s
palsy. (Ex. 7, p. 4; Ex. 63, p. 1.)
25

Case 1:18-vv-01735-UNJ Document 78 Filed 05/22/24 Page 26 of 27
Regarding a logical sequence of cause and effect, Dr. Leist is persuasive in
contending that petitioner’s diabetes alone is a sufficient explanation for his condition.
(Ex. A, p. 5.) There is no question that petitioner had a longstanding history of
uncontrolled diabetes. (E.g., Ex. 63, p. 2 (Dr. Gershwin acknowledging petitioner “had
diabetes for more than a decade, preceding his September 2017 influenza vaccination.
His diabetes has been poorly controlled throughout much of that time.”) Additionally,
Dr. Leist cites literature reflecting a correlation between elevated hemoglobin A1c (as
seen in uncontrolled diabetes) and severity of Bell’s palsy (though not ultimate
prognosis).11 (Ex. A, p. 5 (citing Riga et al., supra, at Ex. 25, p. 6).) And, although
petitioner asserts that he was attempting to manage his diabetes, he acknowledged in
his testimony that his diabetes was not controlled around the time of the onset of his
Bell’s palsy.12 (Tr. 11-13, 39-40, 45-46.) This is confirmed by his medical treatment
records as discussed in the factual summary above, which show his ongoing elevations
in blood glucose and hemoglobin A1C. Moreover, as Dr. Leist observes, there is no
question that petitioner experienced preexisting microvascular compromise leading to
neurologic complications attributable to his diabetes. (Ex. A, p. 5.) Petitioner has
offered no argument that these complications were due to anything other than his
diabetes. In fact, petitioner’s own expert concedes that his Bell’s palsy is at least partly
explained by diabetic nerve damage. (Ex. 7, p. 7 (stating that “[t]he presence of
diabetes in [petitioner] suggests that his facial nerve was already damaged from his
diabetic neuropathy”); Ex. 63, p. 2 (submitting that petitioner “was already compromised
based upon his underlying ischemia from diabetes”).) Dr. Leist is also persuasive in
contending that Dr. Gershwin has no basis for distinguishing inflammatory damage
purportedly due to vaccination from the otherwise undisputed ischemic nerve damages
resulting from petitioner’s diabetes. (Ex. C, p. 2.) Thus, based on all of this, Dr. Leist is
persuasive in opining “that diabetes related microvascular injury is the likely cause of
[petitioner]’s Bell’s palsy.” (Ex. A, p. 5 (emphasis added).)
While Dr. Gershwin is well qualified to discuss the potential immunologic causes
of a clinical syndrome such as Bell’s palsy, Bell’s palsy itself is a form of neuropathy,
which places the condition more firmly in Dr. Leist’s area of clinical expertise with
respect to the spectrum of patient presentations and etiologies for the condition.
Neither expert’s curriculum vitae discloses any specific prior experience with either
Bell’s palsy or diabetes in particular. (Ex. 62; Ex. B.) However, Dr. Leist does represent
that his clinical experience as a board-certified neurologist has included treatment of
11 Dr. Gershwin urges caution regarding the clarity of the relationship observed by Riga et al., given the
limitations noted by the authors (Ex. 69, p. 1; Ex. 7, p. 4), but does not seek to refute the study. In fact,
Dr. Gershwin cited the study approvingly in his first report. (Ex. 7, pp. 3-4.)
12 Specifically, petitioner testified that his diabetes was uncontrolled at the time he first saw Dr. Head, but
that “I would say I began controlling it once I got under her care.” (Tr. 39-40.) Petitioner’s first encounter
with Dr. Head on September 19, 2017, is the same encounter at which he received the subject
vaccinations. (Ex. 2, pp. 218-38; Ex. 5, p. 6.) Petitioner separately testified, however, that he only
subsequently (around 2021) learned of the need to reduce his carbohydrate intake to control his diabetes,
suggesting his earlier efforts to control his diabetes were not fully effective. (Tr. 12-14, 46.)
26

Case 1:18-vv-01735-UNJ Document 78 Filed 05/22/24 Page 27 of 27
patients with Bell’s palsy. (Ex. A, p. 1.) Dr. Gershwin makes no similar representation
and it is not readily apparent that his experience as a rheumatologist/immunologist
would include any experience with patients presenting for Bell’s palsy. Accordingly,
even if all else were equal, Dr. Leist’s opinion would still be entitled to greater weight
with respect to his assessment of petitioner’s clinical history vis-à-vis the underlying
cause of his Bell’s palsy. Where both parties offer expert testimony, a special master's
decision may be “based on the credibility of the experts and the relative persuasiveness
of their competing theories.” Broekelschen v. Sec’y of Health & Human Servs., 618
F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe v. Sec’y of Health & Human Servs., 219
F.3d 1357, 1362 (Fed. Cir. 2000)). In determining whether a particular expert’s
testimony was reliable or credible, a special master may consider whether the expert is
offering an opinion that exceeds the expert’s training or competence. E.g., Walton v.
Sec’y of Health & Human Servs., No. 04-503V, 2007 WL 1467307, at *17-18 (Fed. Cl.
Spec. Mstr. Apr. 30, 2007) (finding that an otolaryngologist was not well suited to testify
about disciplines other than his own specialty).
VI. Conclusion
Petitioner has clearly suffered and he has my sympathy. However, for all the
reasons discussed herein, petitioner has not preponderantly demonstrated that he
actually suffered a vaccine-caused injury and is therefore not entitled to compensation.
Accordingly, this case is dismissed.13
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
13 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter
judgment accordingly.
27

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_18-vv-01735-cl-extra-10735240
Date issued/filed: 2024-05-22
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10268650
--------------------------------------------------------------------------------
           In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                            No. 18-1735V
                                        Filed: April 10, 2024


 W.G.,                                                               Special Master Horner

                         Petitioner,
 v.

 SECRETARY OF HEALTH AND
 HUMAN SERVICES,

                         Respondent.


William E. Cochran, Jr., Black, McLaren, Jones, Ryland & Griffee, P.C., Memphis, TN,
for petitioner.
Bridget Corridon, U.S. Department of Justice, Washington, DC, for respondent.

                                 ORDER ON MOTION TO REDACT 1


        On November 8, 2015, petitioner initiated this action by filing a claim under the
National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2018).2 (ECF No. 1.)
On February 9, 2024, a decision issued dismissing this case. (ECF No. 70.) Petitioner
now moves to redact that decision. (ECF No. 71.) For the reasons discussed below,
petitioner’s motion is GRANTED in part and DENIED in part.
      I.     Legal Standard
      Vaccine Rule 18(b) effectuates the opportunity for objection contemplated by
Section 12(d)(4) of the Vaccine Act, which provides in relevant part that “[a] decision of

1 Because this document 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 document will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2 All references to “§ 300aa” below refer to the relevant section of the Vaccine Act at 42 U.S.C. § 300aa-

10-34.

                                                        1
a special master or the court in a proceeding shall be disclosed, except that if the
decision is to include information…(ii) which are medical files and similar files the
disclosure of which would constitute a clearly unwarranted invasion of privacy, and if the
person who submitted such information objects to such information in the decision, the
decision shall be disclosed without such information.” § 300-aa-12(d)(4)(B). The U.S.
Court of Appeals for the Federal Circuit has not had occasion to interpret this section of
the Vaccine Act. There are, instead, two competing methods of interpretation endorsed
by non-binding precedent. See Langland ex rel. M.L. v. Sec’y of Health & Human
Servs., No. 07-36V, 2011 WL 802695 (Fed. Cl. Spec. Mstr. Feb. 3, 2011); W.C. v. Sec’y
of Health & Human Servs., 100 Fed. Cl. 440 (2011).

        In Langland, the Chief Special Master examined a redaction request pursuant to
Section 12(d)(4)(B) in the context of the common law traditions regarding redaction and
public access, the E-Government Act, and other provisions of the Vaccine Act favoring
public disclosure. 2011 WL 802695, at *5-11. The Chief Special Master concluded that
“the party seeking to seal a document faces a burden to show particularized harm
outweighing the public interest in disclosure. This common law background informs the
correct construction of the language in section 12(d)(4)(B)(ii) and militates against
routine redaction of all sensitive medical information from special masters’ decisions.”
Id. at *8. Upon review of the redaction request at issue, the Chief Special Master
concluded that the request was unsupported and only a redaction of the petitioner’s
minor child’s name to initials and redaction of the child’s birthdate was appropriate. Id.
at *11.

        However, the Chief Special Master also observed that:

        One may readily conceive of medical information in a vaccine case that
        might be redacted by a special master, upon receiving a proper motion in
        accordance with Vaccine Rule 18(b), as meeting the “clearly unwarranted”
        criterion. Facts involving sexual misconduct or dysfunction, family medical
        history not pertinent to the vaccinee’s claim, unrelated mental illness, or
        medical conditions inherently likely to bring opprobrium upon the sufferer,
        might well be redacted upon a proper motion. Such redaction decisions can
        only be reached on a case-by-case basis.

Id. at *9.

        Subsequently, in W.C., the Court of Federal Claims reviewed a redaction request
in the context of the Freedom of Information Act (FOIA), which the court observed to
employ language similar to Section 12(d)(4)(B) of the Vaccine Act. 100 Fed. Cl. at 456-
61. The court focused on the idea that petitioner’s request “must be weighed against
the government’s interest in public disclosure.” Id. at 461. Focusing specifically on the
identity of the petitioner, the court observed that it is the petitioner’s medical history and

                                              2
adverse vaccine reaction, and not petitioner’s own specific identity, that the public has
an interest in seeing disclosed. Id.

       W.C. has been interpreted as providing a more lenient standard for redaction as
compared to Langland. See, e.g., K.L. v. Sec’y of Health & Human Servs., 123 Fed. Cl.
497, 507 (2015) (noting that the Special Master “argued that even when a Special
Master follows the lenient standard for redaction set forth in W.C., requests for redaction
have been denied because they failed to substantiate the basis for the request.”)
Nonetheless, special masters do not abuse their discretion by requiring petitioners to
affirmatively demonstrate that redaction is justified regardless of which approach is
preferred. Id. at 507-08 (finding that the Special Master’s requirement that petitioner
provide “sufficient cause to justify redaction” is not contrary to the Vaccine Act or prior
precedent and explaining that “[e]ach Special Master must review every case and
exercise his or her discretion, given the specific facts presented in that particular case.”)

       Some petitioners move for redaction of their case captions to initials based on
concerns about present and future employment relationships and opportunities. For
example, in Krupp v. Sec’y of Health and Human Servs., petitioner, a science writer,
expressed concern that the fact of her vaccine injury claim would cause her to be
perceived as anti-vaccine, which she feared would be viewed poorly by her colleagues.
No. 19-1501V, 2023 WL 9503417 (Fed. Cl. Spec. Mstr.Jul. 21, 2023). I denied the
motion to redact after finding no professional connection to vaccines specifically and no
inflammatory or unusual allegations in the petition. Id. at 4. Quoting a prior decision, I
noted that blanket fear regarding association with the program does not justify redaction
and further indicated that “it is not the undersigned’s role to become involved in the
ordinary management of petitioner’s online presence.” Id. at 2 (citation omitted).

        However, I have also previously found that redaction to initials was justified
based on future employment concerns when other factors were also present. For
example, in A.T. the petitioner’s identity had initially been protected because she was a
minor at the time of filing and the nature of the condition itself (narcolepsy) and her early
life stage appeared especially likely to hamper future prospects. A.T. v. Sec’y of Health
& Human Servs., No. 16-393V, 2022 WL 819583 at *2 (Fed. Cl. Spec. Mstr. Jan. 13,
2022). See also C.F. v. Sec’y of Health and Human Servs., No. 15-731V, 2023 WL
2583513 (Fed. Cl. Spec. Mstr. Feb. 24, 2023) (granting motion to redact based on
similarity to A.T. as well as discussion within the decision of mental health care). Other
Special Masters have been willing to grant motions to redact where a petitioner
expressed concern that disclosure of their medical information would lead to fewer
opportunities for career growth due to perceived health limitations that would otherwise
remain private. See E.M. v. Sec’y of Health and Human Servs., No. 14-753V, 2021 WL
3702229 (Fed. Cl. Spec. Mstr. Aug. 6, 2021); A.F. v. Sec’y of Health and Human Servs.,
No. 19-0446V, 2023 WL 2387810 (Fed. Cl. Spec. Mstr. Mar. 7, 2023).


                                              3
    II.      Party Contentions
        In his motion, petitioner explains that the decision dismissing his case has a
lengthy discussion of his medical history, including the details of his alleged vaccine
injury and other chronic, unrelated conditions, some of which can be considered
debilitating. (ECF No. 71, p. 2.) He asserts that he is currently employed as a courier
for a laboratory company, which is a physically demanding job given that it involves
urgent deliveries. (Id. at 2-3.) He therefore asserts that he has presented specific facts
from within the decision that would otherwise remain private that are likely to
meaningfully affect his employment. (Id. at 3.) He argues that this justifies the
redaction of the caption to reflect only his initials as well as redaction of the names of
his treating physicians. (Id.) In contrast, he argues the government has no interest in
public disclosure of these details. (Id.)

       In response to petitioner’s motion, respondent provided a recitation of the
relevant case law, namely a comparison of the above-discussed Langland and W.C.
cases. (ECF No. 72, pp. 2-4.) However, citing the language of the Vaccine Act
indicating that decision of special masters “shall be disclosed” (§ 300-aa-12(d)(4)(B)),
respondent stresses that “when petitioners file petitions requesting compensation under
the Act, they do so with knowledge that the Act calls for decisions addressing the merits
of the petitions, which will necessarily contain their medical information and will be
made available to the public.” (Id. at 4.) Respondent continues:

          Congress’s requirement that decisions of special masters “shall be
          disclosed” is evidence that Congress recognized the public’s interest in
          understanding the bases for the special masters’ adjudication of the merits
          of these claims. Respondent likewise acknowledges that there is a privacy
          interest inherent in all medical information. Yet, the Vaccine Act’s use of
          the term “clearly unwarranted invasion of privacy” to define which
          information is suitable for redaction requires a petitioner to show some
          additional privacy interest to justify redaction of a decision. Without such a
          showing, redaction is not appropriate.

(Id.)

        Nonetheless, respondent “defers to the sound discretion of the Special Master to
determine which remedy strikes the appropriate balance between the public and private
interests in this instance.” (ECF No. 72, p. 5.) “Respondent does not believe it is
appropriate to advocate in favor of disclosure of petitioner’s information in any particular
case, including this one, but rather defers to the Special Master’s judgment as to
whether petitioner’s Motion should be granted, applying the analytical framework
discussed above.” (Id.) Respondent does contend, however, that “[t]here is also a
significant Program interest in not having every case caption reduced to initials. This
would make the administration of the Program unmanageable, because the parties and
                                                4
Court rely on citing precedent that is readily accessible and suitably differentiated from
other cases in briefing and arguments.” (Id. at 4.)

          Petitioner filed no reply.
   III.      Discussion
        In this case petitioner’s explanation reasonably supports his redaction request
with respect to his own name. Moreover, consistent with W.C., the redaction of the
caption will not interfere with disclosure of the medical information underlying the
dismissal decision. Petitioner indicates that he works in a physically demanding job and
credibly asserts that extensive disclosure of his chronic health complaints may hamper
his employment in that line of work. (ECF No. 71, pp. 2-3.) As explained above, I have
previously held that concerns about employment can justify redaction in some
circumstances, especially when the nature of the illness is germane. See A.T., 2022
WL 819583, at *2 (granting redaction where petitioner, inter alia, persuasively explained
that “given her age, life stage, and the nature of her medical condition at issue,
disclosure of her condition is especially likely to hamper her future prospects.”)
However, once the case caption has been anonymized, petitioner has not advanced
any specific argument supporting the notion that further redaction of his physicians’
names is also necessary to protect his own identity. Nor has petitioner articulated any
other circumstance or privacy interest that would favor such redaction.

        Accordingly, petitioner’s motion is GRANTED in part and DENIED in part. All
references to petitioner’s name in the caption of the February 9, 2024 decision will be
redacted. Additionally, the Clerk of the Court is hereby instructed to change the caption
of this case to the caption above. However, the names of petitioner’s treating
physicians will not be redacted.

IT IS SO ORDERED.
                                                 s/Daniel T. Horner
                                                 Daniel T. Horner
                                                 Special Master




                                             5