Hickner v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

Filed: June 10, 2025

* * * * * * * * * * * * * * *

STEPHEN HICKNER, M.D., * No. 21-02046V

*

Petitioner, * Special Master Young

*

v. *

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

* * * * * * * * * * * * * * *

Scott W. Rooney, Nemes Rooney, P.C., Farmington Hills, MI, for Petitioner.

Parisa Tabassian, U.S. Department of Justice, Washington, DC, for Respondent.

FACT RULING 1

On October 20, 2021, Stephen Hickner (“Petitioner”) filed a petition pursuant to the

National Vaccine Injury Compensation Program (“the Program”). 2 Petitioner alleged that he

suffered from chronic inflammatory demyelinating polyneuropathy (“CIDP”) 3 resulting from an

influenza (“flu”) vaccine administered on October 26, 2018. Pet. at 2, ECF No. 1. However,

1

Because this Ruling 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 Ruling 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

National Childhood Vaccine Injury Act of 1986, Pub L. No. 99-660, 100 Stat. 3755 (“the Vaccine Act”

or “Act”). Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent

subparagraph of 42 U.S.C. § 300aa (2018).

3

CIDP is “a slowly progressive, autoimmune type of demyelinating polyneuropathy characterized by

progressive weakness and impaired sensory function in the limbs and enlargement of the peripheral

nerves, usually with elevated protein in the cerebrospinal fluid.” Dorland’s Illustrated Medical Dictionary

1468 (33rd ed. 2020) [hereinafter “Dorland’s”]. Neuropathy refers to “a functional disturbance of

pathologic change in the peripheral nervous system.” Id. at 1250. Polyneuropathy, also known as

peripheral neuropathy, is “neuropathy of several peripheral nerves simultaneously.” Id. at 1468.

Demyelination is “destruction, removal, or loss of the myelin sheath of a nerve or nerves.” Id. at 480. A

myelin sheath is “the cylindrical covering on the axons of some neurons.” Id. at 1673. Axon is “the

process of a neuron by which impulses travel away from the cell body.” Id. at 183.

1

Respondent contended the temporal relationship between the administration of the vaccine and the

onset of Petitioner’s symptoms is too remote to establish causation. Resp’t’s Rept. at 15, ECF No.

60. After carefully analyzing and weighing all of the evidence presented in this case in accordance

with the applicable legal standards, 4 I find that the record contains preponderant evidence that

Petitioner’s symptoms began no earlier than Spring of 2019, or approximately five months post

vaccination.

I. Procedural History

Petitioner filed his petition on October 20, 2021. Pet. Petitioner filed medical records on

October 21, 2021. ECF No. 6; Pet’r’s Ex. 4, ECF No. 7. He then filed an affidavit on October 25,

2021. Pet’r’s Ex. 1, ECF. No. 9. Petitioner filed additional medical records between October 26,

2021, and December 8, 2021, as well as a statement of completion on February 9, 2022. Pet’r’s

Ex. 2, ECF No. 11; Pet’r’s. Ex. 3 & 5, ECF No. 13; Pet’r’s Ex. 6, ECF No. 15; Pet’r’s Ex. 7, ECF

No. 17; Pet’r’s Ex. 8, ECF. No. 19; Pet’r’s Ex. 9, ECF No. 21; ECF No. 23. Petitioner again filed

additional medical records between August 3, 2022, and October 31, 2022, as well as an amended

statement of completion on October 31, 2022. Pet’r’s Ex. 10, ECF No. 33; Pet’r’s Ex. 11, ECF No.

36; Pet’r’s Ex. 12, ECF No. 39; Pet’r’s Ex. 13, ECF No. 41; Pet’r’s Ex. 14, ECF No. 43; Pet’r’s

Ex. 15, ECF No. 47; ECF No. 49. Petitioner filed additional medical records on December 20,

2022, and December 21, 2022. Pet’r’s Ex. 16, ECF No. 51; Pet’r’s’ Ex. 17–20, ECF No. 53.

Respondent filed his Rule 4(c) report, opposing compensation, on January 31, 2023.

Resp’t’s Rept. at 1. Among other issues, he argued that Petitioner had not presented reliable

evidence to show the time between his flu vaccination and the actual onset of his symptoms was

“medically acceptable to infer causation-in-fact.” Id. at 15 (citation omitted). Respondent noted

that Petitioner “initially reported neurologic symptoms on August 28, 2019, and inconsistently

reported that his symptoms began between spring and summer 2019.” Id. He further claimed that

no evidence had been provided to support “a reasonable proximate temporal relationship of five

or more months between vaccination and neurological symptom onset.” 5 Id. at 16. Petitioner filed

additional medical records in March and May of 2023. Pet’r’s Ex. 21, ECF No. 65; Pet’r’s. Ex. 22.

I held a status conference on October 3, 2023, to discuss the onset issue raised in

Respondent’s Rule 4(c) report. Min. Entry, docketed Oct. 3, 2023. Following the status conference,

I issued a scheduling order directing Petitioner to file affidavits regarding the onset of his

neurological symptoms and a motion for a fact ruling by November 15, 2023. ECF No. 73.

Petitioner filed an affidavit from his wife, Carol Hickner, on December 13, 2023. Pet’r’s Ex. 23,

ECF No. 75. On December 14, 2023, Petitioner filed a brief addressing the onset issue and

4

While I have reviewed all of the information filed in this case, only those filings and records that are

most relevant to the decision will be discussed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d

1322, 1328 (Fed. Cir. 2016) (“We generally presume that a special master considered the relevant record

evidence even though he does not explicitly reference such evidence in his decision.”) (citation omitted);

see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (“Finding

certain information not relevant does not lead to—and likely undermines—the conclusion that it was not

considered.”).

5

Petitioner claimed the vaccination that allegedly cause his injury was administered on October 26, 2018.

Pet. at 2.

2

requested the case proceed with expert reports. Pet’r’s Br., ECF No. 77. Petitioner also filed

supporting medical literature. Pet’r’s Ex. 24–27, ECF No. 78. Respondent filed a response on

February 6, 2024, and Petitioner filed a reply on April 1, 2024. Resp’t’s Br., ECF No. 80; Pet’r’s

Reply, ECF No. 82.

This matter is now ripe for consideration.

II. Factual Background

A. Medical Records

On October 26, 2018, Petitioner received the Seqirus flu vaccine through his employment

via Saint Joseph Mercy Health System. Pet’r’s Ex. 2 at 3. On November 29, 2018, Petitioner

presented to his primary care provider (“PCP”), Bruce Cicone, M.D. Pet’r’s Ex. 6 at 18. He

reported “worsening” hip pain but did not report any neurological symptoms, and Dr. Cicone noted

Petitioner’s neurological functions as “[n]ormal” upon physical examination. Id. at 18, 21. Dr.

Cicone ordered an X-ray of Petitioner’s hip, referred him to physical therapy, and prescribed him

atorvastatin for his ongoing dyslipidemia. Id. at 18–19. On December 6, 2018, Petitioner

underwent a right hip X-ray, which revealed advanced degenerative joint disease. Pet’r’s Ex. 8 at

344.

On January 30, 2019, Petitioner presented to IHA Orthopedic Specialists (“IHA”) with

complaints of right hip pain. Pet’r’s Ex. 13 at 1. Physician’s assistant (“PA”) Matthew N. Hodrosky

administered a cortisone 6 injection into Petitioner’s right hip. Id. Petitioner followed up at IHA

again on April 17, 2019, with further complaints of right hip pain. Pet’r’s Ex. 10 at 40. Petitioner

stated the first injection had provided “significant pain relief,” but its effects had worn off and

requested a second injection. Id. PA Hodrosky diagnosed Petitioner with right hip osteoarthritis 7

and administered a second cortisone injection into Petitioner’s right hip. Id. It was noted that

Petitioner was scheduled to undergo a total hip arthroplasty 8 of his right hip on July 21, 2019. Id.

No neurological symptoms were noted at either visit. Id.; Pet’r’s Ex. 13 at 1; Pet’r’s Ex. 10 at 40.

Petitioner was approved for surgery by orthopedic surgeon Michael Masini, M.D., on July

10, 2019, and the procedure was performed on July 23, 2019. Pet’r’s Ex. 10 at 28; Pet’r’s Ex. 8 at

86. Petitioner was discharged on July 11, 2019. Id. at 30. Petitioner followed up with Dr. Masini

on August 14, 2019, and Dr. Masini did not note any neurological symptoms. Pet’r’s Ex. 7 at 3.

Dr. Masini noted Petitioner was “progressing well overall” and prescribed him physical therapy.

Id.

Two weeks later, on August 28, 2019, approximately ten months after his vaccination,

Petitioner presented to Dr. Cicone with complaints of numbness in his fingers and toes, right hip

pain, and high blood pressure. Pet’r’s Ex. 6 at 10. Dr. Cicone noted that Petitioner stated the onset

6

Cortisone is “a natural glucocorticoid that is metabolically convertible to cortisol.” Dorland’s at 417.

7

Osteoarthritis is “a noninflammatory degenerative joint disease . . . characterized by degeneration of the

articular cartilage, hypertrophy of bone at the margins, and changes in the synovial membrane.”

Dorland’s at 1326.

8

A total hip arthroplasty is “a plastic surgery [on both sides of the hip] joint.” Dorland’s at 155–56.

3

of the numbness “was [six] weeks ago” and included symptoms of paresthesia and referred

Petitioner to a neurology specialist. 9 Id. On September 25, 2019, Petitioner again presented to Dr.

Cicone with complaints of numbness in his right arm. Id. at 6. Dr. Cicone noted that Petitioner

thought the numbness was related to his high blood pressure and hypertension. Id. Petitioner also

received another flu vaccination at this appointment. Id. at 8. In the immunization screening

questionnaire, Petitioner self-reported “No” to whether he had “ever had a serious reaction after

receiving a vaccination” and whether he had “a seizure, brain, or other nervous system problem.”

Id.

Per Dr. Cicone’s referral, on October 16, 2019, Petitioner presented to neurologist Amanda

Rabquer, M.D., with complaints of numbness and tingling, which began prior to his July 2019 hip

surgery. Pet’r’s Ex. 5 at 1. Petitioner reported his symptoms had “waxed and waned” and were

“equal in both hands.” Id. He also reported that his symptoms worsened at the end of the day,

especially when he “does more surgeries or keyboarding.” Id. Physical examination revealed

decreased reflexes in Petitioner’s bilateral biceps, triceps, and brachioradialis. Id. at 2. Patella and

ankle reflexes were also absent. 10 Id. Dr. Rabquer noted Petitioner’s neuropathy 11 had progressed

minimally since Petitioner’s reported onset date and opined that carpal tunnel syndrome 12 “is a

consideration given the more prominent symptoms in his hands and his type of work[,] but this

would not explain the symptoms in his toes.” Id. at 1. Dr. Rabquer assessed that the causation of

Petitioner’s symptoms was “unclear at this time” and ordered an electromyogram (“EMG”) to

“help sort things out.” Id.

Petitioner’s EMG was conducted on November 27, 2019, and revealed “evidence of a

moderately severe right median mononeuropathy at the wrist without active denervation/carpal

tunnel syndrome.” Pet’r’s Ex. 5 at 12. Dr. Rabquer noted “there was no evidence of a diffuse large

fiber polyneuropathy.” Id. Petitioner had stated that between this and the October 16, 2019, visit

he had travelled for a conference for over a week and his symptoms had resolved. Id. However,

Petitioner reported his symptoms had begun to return in his hands once he began working again.

Id. Dr. Rabquer diagnosed Petitioner with bilateral carpal tunnel syndrome and advised him to

wear wrist braces at night to help relieve his symptoms. Id. at 11.

Petitioner followed up with Dr. Rabquer on June 10, 2020, and reported a worsening of the

symptoms in his hands and feet despite not having worked since the onset of the COVID-19

pandemic. Pet’r’s Ex. 5 at 5–6. Petitioner reported that his paresthesia was spreading to his entire

hand and the soles of his feet, that he was beginning to feel a burning sensation in his hands, and

that he had begun to experience mild balance problems. Id. He reported that he had not been

wearing his wrist braces consistently, and they were not providing much benefit. Id. at 6. Dr.

9

Paresthesia is “an abnormal touch sensation, such as burning, prickling, or formication, often in the

absence of an external stimulus.” Dorland’s at 1362.

10

Dr. Rabquer also noted Petitioner’s reflex deficiencies may have resulted from her inability to fully

relax the Petitioner’s muscles. Pet’r’s Ex. 5 at 1.

11

This is the first instance in the medical record where Petitioner’s symptoms were described as a

“neuropathy.” Dr. Cicone had previously referred to Petitioner’s symptoms as “paresthesia” and “neuro-

numbness” at Petitioner’s visits on August 28, 2019, and September 25, 2019. Pet’r’s Ex. 6 at 6, 10.

12

Carpal tunnel is “an entrapment neuropathy characterized by pain and burning or tingling paresthesias

in the fingers and hand, sometimes extending to the elbow.” Dorland’s at 1794.

4

Rabquer discussed with him the possibility of an early distal symmetric large fiber polyneuropathy

and ordered magnetic resonance imaging (“MRI”) of Petitioner’s cervical spine to rule out any

structural lesions. Id. at 5. Petitioner underwent the MRI on June 21, 2020, which revealed “[m]ild

cervical spondylosis[13] . . . [m]ild-moderate cervical facet hypertrophy[14] . . . [and m]inimal/mild

discogenic degenerative changes . . . [within the] cervical spine.” Id. at 24.

On August 3, 2020, Petitioner presented to Shailee Shah, M.D., at the Mayo Clinic for his

paresthesia. Pet’r’s Ex. 3 at 3. He reported his symptoms began in the Spring of 2019 and described

how they had spread from his fingertips and toes to the palms of his hands and the balls of his feet.

Id. Dr. Shah assessed Petitioner to have ascending stocking glove distribution neuropathy. Id. at

4. Dr. Shah also observed Petitioner had reduced strength in both hands, “decreased sensation to

temperature and pinprick up to the knees and mid forearms bilaterally,” and reduced reflexes, and

ordered broad testing to determine the cause of the neuropathy. Id. That same day Petitioner was

also evaluated by Dr. Shah’s supervisor, Oliver Tobin, M.B., who noted reflexes “absent

throughout,” reduced pinprick sensation in Petitioner’s hands and feet, and reduced vibration

sensation in his wrists and ankles. Id. at 7. Dr. Tobin assessed Petitioner to have a “slowly

progressive sensory motor syndrome” in his peripheral nerve which was progressing faster than a

genetic neuropathy. Id.

On August 3 and 4, 2020, Petitioner underwent a fat aspirate, lumbar puncture, and nerve

punch biopsy, which showed a high protein level in Petitioner’s spinal fluid. Pet’r’s Ex. 3 at 9–12.

Relying on these findings, in addition to Petitioner’s previous EMG and current symptoms, on

August 5, 2020, Dr. Tobin diagnosed Petitioner with chronic inflammatory sensory

polyneuropathy (“CISP”), a form of CIDP, to be treated with intravenous immunoglobulin

(“IVIG”). Id. at 12–13. The same day, Petitioner also underwent an EMG and MRI, which revealed

evidence of a diffuse sensory peripheral neuropathy and enlargement of the lumbosacral plexus, 15

sciatic, and femoral nerves, respectively. Id. at 77–78, 99–100.

On August 6, 2020, Petitioner presented to neurologist Divyanshu Dubey, M.B.B.S., at the

Mayo Clinic for further evaluation of his peripheral neuropathy. Pet’r’s Ex. 3 at 13. Petitioner

again reported to Dr. Dubey that his symptoms began in the Spring of 2019 and added that “[o]ver

the next few months he started noticing numbness involving [his] toes as well.” Id. Dr. Dubey

noted Petitioner’s “evaluations [were] concerning for sensory predominant immune mediated

polyradiculoneuropathy” 16 and agreed with Dr. Tobin’s recommendation to begin IVIG treatment.

Id. at 16. On August 7, 2020, Petitioner presented to hematologist Mustaqeem A. Siddiqui, M.D.,

due to a concern of non-quantifiable IgG kappa from his serum protein studies. Id. at 18. Dr.

Siddiqui opined that due to the current testing revealing a CIDP variant and Petitioner’s sweat test

resulting as normal, Petitioner’s symptoms were “unlikely to be amyloid neuropathy” and he

concurred with a CIDP diagnosis to be treated with IVIG. Id. at 17–18. Petitioner began his IVIG

13

Spondylosis is the “dissolution of a vertebra.” Dorland’s at 1725.

14

Hypertrophy is “the enlargement or overgrowth of an organ or part due to an increase in size of its

constituent cells.” Dorland’s at 886.

15

The lumbosacral plexus is “a term applied to the lumbar and sacral nerve plexuses together, because of

their continuous nature.” Dorland’s at 1442.

16

Polyradiculoneuropathy is “any disease of the peripheral nerves and spinal nerve roots.” Dorland’s at

1470.

5

treatments at the Mayo Clinic on August 10, 2020, and received 12 total infusions at the Mayo

Clinic between August 10, 2020, and November 6, 2020. Pet’r’s Ex. 14 at 22, 36, 53–57, 67, 76,

85, 91–92.

On November 17, 2020, Petitioner presented to neurologist Amro M. Stino, M.D., to

establish care closer to his residence in Michigan. Pet’r’s Ex. 9 at 10, 18. Petitioner reported

again that his symptoms began in the Spring of 2019 and progressed after undergoing a right hip

surgery. Id. at 18. Dr. Stino noted Petitioner had “very mild pinprick loss in hands” and

concurred with the diagnosis of the CISP variant of CIDP. Id. at 20, 22. Petitioner began weekly

infusions of IVIG on November 19, 2020, and received 26 IVIG infusions at home between

November 19, 2020, and August 12, 2021. Pet’r’s Ex. 16 at 33–43, 648–759.

From February 23, 2021, to February 1, 2022, Petitioner continued regular follow-ups

with Dr. Stino and the Mayo Clinic for the progression of his symptoms. Pet’r’s Ex. 3 at 39;

Pet’r’s Ex. 9 at 66, 132, 205, 231; Pet’r’s Ex. 16 at 444.

No other relevant medical records were filed.

B. Affidavits

1. Affidavit of Petitioner

On October 25, 2021, Petitioner filed a brief affidavit. Pet’r’s Ex. 1. He stated that “[w]ithin

days after receiving the vaccination, [he] felt numbness and tingling in [his] hands” and that he

“developed fatigue, loss of muscle strength and stamina . . . sleeplessness[,] . . . [and] restless leg

syndrome.” Id. at ⁋⁋ 7, 10–11. He also stated that in “Spring 2019 . . . [he] noted progression of

numbness and tingling of [his] hands and feet, which [he] reported to [his PCP].” Id. at ⁋ 13.

Petitioner further stated that his testing at the Mayo Clinic “confirmed a diagnosis of [CIDP].” Id.

at ⁋ 19.

2. Affidavit of Petitioner’s Wife, Carol Hickner

On December 13, 2023, Petitioner filed a brief affidavit by his wife, Carol Hickner. Pet’r’s

Ex. 23. She stated that “[i]n the ensuing weeks after [her] husband received the [f]lu vaccine on

October 26, 2018, [she] observed a decline in his physical health.” Id. at ⁋ 2. She noted that

Petitioner complained of “worsening tiredness and fatigue . . . restless legs in the evenings . . . and

numbness and tingling in his hands and forearms.” Id. at ⁋⁋ 3, 9–10. Ms. Hickner specifically noted

that Petitioner had never complained of this numbness prior to his vaccination and that she had

begun to observe him “dropping glassware . . . [having] difficulty buttoning his shirt and tying his

ties . . . [and] occasionally stumble.” Id. at ⁋⁋ 16, 17, 19. She also stated that Petitioner refused to

go on walks or bike rides with her due to his symptoms. Id. at ⁋⁋ 5, 23. Ms. Hickner further stated

that Petitioner began to complain of “numbness and tingling in his feet and a decline in balance”

following his July 2019 hip surgery. Id. at ⁋ 28. Due to Petitioner’s ongoing symptoms, Ms.

Hickner stated that she “urged him to make an appointment with Mayo Clinic” where he “was

diagnosed with CIDP.” Id. at ⁋⁋ 40, 43.

6

III. Parties’ Arguments

In his brief, Petitioner discusses the issues regarding his symptom onset, including the

contradictions between the affidavits and his medical records, and the medical theory supporting

Petitioner’s claim. With regard to Petitioner’s medical records, Petitioner argues Respondent

“confuses onset with delayed diagnosis,” and cites to various pieces of medical literature 17 to

indicate his symptoms were masked and reduced by two 80mg steroid injections in his right hip

on January 30, 2019, and April 17, 2019. Pet’r’s Br. at 5–6. Petitioner notes that “[c]ortisteroids

are used commonly for initial treatment of [CIDP]” and that this “would have masked or lessened

the CIDP symptoms to the extent that the treaters logically would have misdiagnosed the onset of

the symptoms of CIDP.” Id. at 6. Petitioner further argues that because he was “given cortisteroids

for the treatment of his pain, it is clear that this would have ameliorated his CIDP symptoms, thus

putting the purported onset as being later than it actually occurred.” Id. at 6–7. Petitioner further

notes that “[d]elayed diagnosis of CIDP has been reported to range from [two to] 64 months,” and

that a study had shown 26% of CIDP cases had a delayed diagnosis of 12 months or longer. Id. at

7 (citing Chaudhary & Rajabally at 2). 18 Petitioner thus argues that “[i]t is logical and factual that

the cortisteroid injections that Petitioner received in January and April 2019 lessened his symptoms

and created the perfect opportunity for both misdiagnosis, but also a misunderstanding of onset.”

Id.

With regard to Petitioner’s medical theory, Petitioner notes that the above argument

demonstrates that onset occurred earlier than the five to eight months indicated in his medical

records, and even if it did not, that “the medical literature demonstrates that CIDP is often plagued

by repeated episodes of demyelination and remyelination,” and thus the Court should consider this

as sufficient to support an onset later than 42 days after vaccination. Id. at 7–8 (citing Lewis &

Muley at 3). 19

Respondent argues that Petitioner’s medical records “clearly and consistently document no

neurological symptoms until August 2019, when [P]etitioner specifically state[d] the symptoms

began six weeks prior (July 2019).” Resp’t’s Br. at 13 (citing Pet’r’s Ex. 6 at 10). He further states

that “[P]etitioner repeatedly reported the onset of his neurological symptoms as between Spring

and Fall 2019.” Id. Respondent also argues that because Petitioner is a physician he “would have

been uniquely aware of the importance of accurately relaying the timeline of his symptoms to his

treating medical providers.” Id. Respondent further argues that Petitioner “unduly” focuses on the

issue of delayed diagnosis, as “[a]ny references to symptoms waxing and waning in the medical

17

G. G. A. van Lieverloo, et. al., Corticosteroids in Chronic Inflammatory Demyelinating

Polyneuropathy: A Retrospective, Multicentre Study, Comparing Efficacy and Safety of Daily

Prednisolone, Pulsed Dexamethasone, and Pulsed Intravenous Methylprednisolone, 265 J. NEUROL. 2052

(2018); P. James B. Dyck & Jennifer A. Tracy, History, Diagnosis, and Management of Chronic

Inflammatory Demyelinating Polyradiculoneuropathy, 93 MAYO CLINIC PROC. 777 (2018).

18

Umair J. Chaudhary & Yusuf A. Rajabally, Underdiagnosis and Diagnostic Delay in Chronic

Inflammatory Demyelinating Polyneuropathy, 268 J. NEUROL. 1366 (2021).

19

Richard A. Lewis & Suraj Ashok Muley, Chronic Inflammatory Demyelinating Polyneuropathy:

Etiology, Clinical Features, and Diagnosis, UPTODATE (Aug. 11, 2023),

https://www.uptodate.com/contents/chronic-inflammatory-demyelinating-polyneuropathy-etiology-

clinical-features-and-diagnosis.

7

records occur after [P]etitioner began complaining of numbness and tingling to his medical

providers . . . approximately ten months and beyond post vaccination. Id. at 13–14 (citing Pet’r’s

Ex. 5 at 6, 11–12; Pet’r’s Ex. 9 at 18) (emphasis in original).

Respondent also notes that due to the timing of Petitioner’s October 2018 vaccination

and January 2019 cortisone injection, there were “three whole months without any potential steroid

interference during which [P]etitioner should have reasonably been able to detect any neurological

symptoms. Yet, he never reported to any medical providers that he experienced any neurological

symptoms during that three-month period,” Id. at 14. Further, Petitioner did not complain of

symptoms after the first injection had worn off. Id. Respondent further notes that both injections

were 80mg doses, “which is not high enough to suggest lasting systemic impact.” Id. at 15 (citing

Pet’r’s Ex. 10 at 42; Pet’r’s Ex. 13 at 1). He further argues that “[i]t is not clear whether such

treatment would have had a global effect of disguising neurological symptoms throughout the

whole body for multiple months.” Id. Respondent concludes by noting that even if Petitioner’s

diagnosis was delayed, it “[has] no bearing on this onset issue,” as “nowhere in the medical records

did [P]etitioner ever report the existence of any symptoms related to CISP/CIDP prior to August

2019, and nowhere did he report that such symptoms began prior to Spring 2019.” Id.

Petitioner’s reply brief addresses the five- to eight-month time interval between vaccination

and onset and argues that previous cases have stated “a longer interval is justified” for the onset of

CIDP. Pet’r’s Reply at 5 (citing Glassberg v. Sec’y of Health & Hum. Servs., No. 07-303V, 2009

WL 464196, at *4 (Fed. Cl. Spec. Mstr. Nov. 23, 2009)). Petitioner further argues that while he is

“a surgeon practicing in obstetrics and gynecology, he is not a clinical immunologist nor a

neurologist.” Id. at 6. He continues that “[t]he fact that he had a problem with fatigue, running,

and clumsiness in the weeks and months post-vaccination does not mean that he should have

related these to his general practitioner since these were not areas of inquiry by his nurse

practitioner nor his treater.” Id. Petitioner further notes the telehealth nature of Petitioner’s early

medical appointments did not provide the opportunity for a neurological examination. Id.

IV. Legal Standards

To receive compensation under the Vaccine Act, a petitioner must demonstrate either that:

(1) the petitioner suffered a “Table injury” by receiving a covered vaccine and subsequently

developing a listed injury within the time frame prescribed by the Vaccine Injury Table set forth

at 42 U.S.C. § 300aa-14, as modified by 42 C.F.R. § 100.3; or (2) the petitioner suffered an “off-

Table injury,” one not listed on the Table, as a result of his receiving a covered vaccine. See 42

U.S.C. §§ 300aa-11(c)(1)(C); Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321

(Fed. Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1319–20 (Fed. Cir.

2006).

Special masters, as finders of fact, “are entitled—indeed, expected—to make

determinations as to the reliability of the evidence presented to them and, if appropriate, as to the

credibility of the persons presenting that evidence.” Moberly, 592 F.3d at 1326. The process for

making determinations in Vaccine Program cases regarding factual issues begins with

consideration of the medical records. § 11(c)(2). The special master is required to consider “all []

relevant medical and scientific evidence contained in the record,” including “any diagnosis,

conclusion, medical judgment, or autopsy or coroner’s report which is contained in the record

8

regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,

condition, or death,” as well as “the results of any diagnostic or evaluative test which are contained

in the record and the summaries and conclusions.” § 13(b)(1)(A). The special master is then

required to weigh the evidence presented, including contemporaneous medical records and

testimony. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993). Pursuant

to Vaccine Act § 13(a)(1)(A), a petitioner must prove her claim by a preponderance of the

evidence. A special master must consider the record as a whole but is not bound by any diagnosis,

conclusion, judgment, test result, report, or summary concerning the nature, causation, and

aggravation of the petitioner’s injury or illness that is contained in a medical record. § 13(b)(1).

In Program cases, contemporaneous medical records and the opinions of treating

physicians are favored. Capizzano, 440 F.3d at 1326 (citing Althen v. Sec’y of Health & Hum.

Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005)). This is because “treating physicians are likely to be

in the best position to determine whether ‘a logical sequence of cause and effect show[s] that the

vaccination was the reason for the injury.’” Id. In addition, “[m]edical records, in general, warrant

consideration as trustworthy evidence.” Cucuras v. Sec’y of Health & Hum. Servs., 933 F.2d 1525,

1528 (Fed. Cir. 1993). Indeed, contemporaneous medical records are ordinarily to be given

significant weight due to the fact that “the records contain information supplied to or by health

professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment

hanging in the balance, accuracy has an extra premium. These records are also generally

contemporaneous to the medical events.” Id. Contemporaneous medical records are also generally

found to be afforded greater weight than contradictory oral testimony. United States v. U.S.

Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is

in conflict with contemporaneous documents is entitled to little evidentiary weight.”).

However, there is no “presumption that medical records are accurate and complete as to all

of the patient’s physical conditions.” Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383

(Fed. Cir. 2021) (finding that a special master must consider the context of a medical encounter

before concluding that it constitutes evidence regarding the absence of a condition.). While a

special master must consider these opinions and records, they are not “binding on the special

master or court.” § 13(b)(1). Rather, when “evaluating the weight to be afforded to any such . . .

[evidence], the special master . . . shall consider the entire record.” Id.

In determining the accuracy and completeness of medical records, special masters will

consider various explanations for inconsistencies between contemporaneously created medical

records and later given testimony. The Court of Federal Claims has identified four such

explanations for explaining inconsistencies: (1) a person’s failure to recount to the medical

professional everything that happened during the relevant time period; (2) the medical

professional’s failure to document everything reported to her or him; (3) a person’s faulty

recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of

symptoms that did not exist. La Londe v. Sec’y of Health & Hum. Servs., 110 Fed. Cl.

184, 203 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014).

V. Discussion

Ten months post vaccination, on August 28, 2019, Petitioner presented to Dr. Cicone, his

primary care physician, with complaints of numbness and tingling in his fingers and toes, which

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Petitioner reported began six weeks prior in July 2019. This was the first reported instance of

Petitioner’s symptoms found in the entirety of his medical record, and in each following instance,

Petitioner consistently reported to physicians that his symptoms began in the Spring of 2019. I find

that these contemporaneous records provide preponderant evidence that Petitioner’s neuropathy

symptoms began no earlier than five months post vaccination.

Petitioner relied heavily on the affidavits of himself and his wife to support the contention

that his symptoms began in the “days” and “weeks” following his October 2018 vaccination. He

asserted three arguments to support his claim: (1) the steroid injections he received in his right hip

in January and April of 2019 masked his symptoms for five months; (2) the nature of CIDP and

inability for in-person medical visits during the pandemic delayed his diagnosis; and (3) the

gradual nature of CIDP requires acceptance of a longer timeframe for symptom onset and

identification within the Program. Pet. Br. at 5. As discussed below, I find that these reasons and

the evidence provided to support them do not sufficiently explain the inconsistences between the

contemporaneously created medical records and later provided affidavits in this case.

A. Petitioner’s Steroid Injections

Petitioner’s primary contention is that the steroid injections he received in his right hip in

January and April of 2019 masked and reduced his CIDP symptoms “for at least five to eight

months until they wore off which is consistent with the medical history timeline.” Pet’r’s Br. at 5.

In addition to the statements made in the submitted affidavits, he supported this theory by citing

primarily to two pieces of medical literature. However, both the medical literature itself and

Petitioner’s counsel’s independent analysis 20 of it are insufficient to satisfy the preponderant

evidence standard.

Petitioner cited to van Lieverloo, et. al. and Dyck & Tracy to demonstrate the effect of

corticosteroids as a treatment for patients with CIDP. Petitioner specifically noted that

corticosteroids are “used commonly for initial treatment of [CIDP]” and that due to Petitioner’s

cortisone injections, “it is clear that this would have ameliorated his CIDP symptoms, thus putting

the purported onset as being later than it actually occurred.” Pet’r’s Br. at 6–7. However, the

treatments outlined in the literature are not sufficiently comparable to Petitioner’s treatment.

In Petitioner’s case, he received two 80mg injections of methylprednisolone 21 administered

four months apart. In the van Lieverloo et al. study, patients received intravenously “pulsed

methylprednisolone, starting with 500mg daily for 4 days.” Pet’r’s Ex. 27 at 3. This was more than

six times the dosage administered to Petitioner and more than twelve times the total amount

administered to Petitioner over the course of his treatment. Additionally, the patients received the

treatments in a much smaller timeframe of four days compared to the four months between

Petitioner’s injections. While van Lieverloo et al. does reference two other treatment methods with

a lower steroid dosage, these treatment plans are also distinguishable. They both used steroids that

20

It should be noted that Petitioner’s counsel has not presented any credentials indicating any formal

medical training he has received and is not a medical expert, nor does he hold himself out to be. No expert

reports were filed by Petitioner in this case.

21

Petitioner’s exact medication received was DepoMedrol, which is a “trademark for preparations of

methylprednisolone.” Dorland’s at 486.

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were (1) different than what the Petitioner received in his injection; (2) administered orally; and

(3) part of a significantly longer treatment regimen that included daily or regular administration

for six to eight months. While all three forms of treatment referenced in the study saw

approximately 60% of patients showed improvement, Petitioner has not shown how his treatment

of only 80mg of methylprednisolone injected directly into his right hip at four months apart would

have any similar impact on his symptoms, much less entirely mask them for five to eight months.

Petitioner’s reliance on the Dyck and Tracy article suffers the same flaw. While the article

does reference several studies detailing the success of using corticosteroids in the treatment of

CIDP patients, all of these studies are for treatment plans which include doses administered closer

together, over a longer period of time, and with a substantially higher total dosage than Petitioner’s

two 80mg injections. 22 Petitioner over relies on the fact that corticosteroids are used to treat CIDP.

He provided no evidence or analysis as to how his specific course of treatment could have produced

an effect similar to the results detailed in the studies he referenced.

Second, even if Petitioner’s injections did mask his symptoms, it does not account for the

asymptomatic three-month period between the date of Petitioner’s flu vaccination on October 26,

2018, and his first hip injection on January 30, 2019. Petitioner attempted to explain this by

referring to the affidavits of himself and his wife, which both indicate he began experiencing

symptoms of fatigue, clumsiness, numbness, and tingling within the days and weeks immediately

following his vaccination. He blamed pandemic era restrictions on healthcare for gaps in the

medical record, and further argued that he did not report these symptoms to his PCP because they

were beyond the scope of his care. There are instances where a person’s failure to recount to a

medical professional every symptom during the relevant time period is reasonable. La Londe, 110

Fed. Cl. at 203. Indeed, this occurs frequently in SIRVA cases, wherein a patient reserves shoulder

complaints for an orthopedist, despite undergoing another, unrelated medical examination.

However, this allowance still does not explain Petitioner’s consistent statements throughout the

medical record that his symptoms began in the Spring of 2019, or his initial statement in August

2019 that his symptoms began six weeks prior, in July 2019. Assuming that Petitioner did not feel

his symptoms at that time were sufficient to warrant complaints to his treating physician, he made

no mention of experiencing these symptoms during that period until he filed his affidavit for this

case.

As explicitly stated in § 13(a)(1) of the Vaccine Act, “[t]he special master or court may not

make a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by

medical opinion.” And while case law does establish that a medical record itself cannot be

presumed to be complete or accurate, Cucuras and Gypsum both show that consistent

contemporaneous medical records can and should be given greater weight than later contradictory

testimony. See Kirby, 997 F.3d at 1382–83 (holding that “Cucuras stands for the unremarkable

proposition that it was not erroneous to give greater weight to contemporaneous medical records

22

Dyck & Tracy, supra n. 17gl at 10 (referencing various studies showing “with 3 months of oral

prednisone reported some improvements,” “weekly oral methylprednisolone treatment found remission in

6 of 9 patients after a mean treatment period of 27 months,” “[1000mg] of intravenous

methylprednisolone initially daily and then monthly for 5 years,” and “6 monthly doses of

dexamethasone . . . with a daily dose of prednisolone . . . for 5 weeks with tapering to none at the end

of 32 weeks.” (emphasis added)).

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than to later, contradictory testimony”); see also Cucuras, 933 F.2d at 1528 (citing Gypsum, 333

U.S. at 396 (noting that “the Supreme Court counsels that oral testimony in conflict with

contemporaneous documentary evidence deserves little weight”)). Ultimately, Petitioner’s

assertion that his steroid injections masked his symptoms is not supported by the preponderant

evidence to overcome his own statements to treaters that consistently identify his symptom onset

at Spring 2019. Furthermore, the filed medical literature does not support Petitioner’s contention

that his treatment was rigorous enough to mask his symptoms for several months.

B. Delayed Diagnosis vs Onset

Petitioner also argued that Respondent “confuses onset with delayed diagnosis,” again

relying on the claims contained in affidavits to show his symptoms began within a month of

vaccination. Pet’r’s Br. at 5. Petitioner cited to medical literature that notes CIDP is frequently

misdiagnosed, resulting in delayed diagnosis of over 12 months in several cases. Indeed, in cases

of polyneuropathy, it can be difficult for treaters to identify the specific condition given the

symptom overlap within this umbrella of diseases. However, Petitioner does not explain how

Petitioner’s eventual CIDP diagnosis, delayed or otherwise, has any effect on when he first felt or

reported the relevant symptoms of fatigue, numbness, and tingling. Petitioner asserted that the

“waxing and waning” of his symptoms in the weeks immediately following his vaccination is

indicative of relapsing-remitting CIDP and made it harder to diagnose. Pet’r’s Br. at 5. That may

be true, but diagnosis date is not at issue in this case. The issue here is the lack of evidence to

support a symptom onset before the Spring of 2019 in the medical record.

Further, Petitioner only began to characterize his symptoms as “waxing and waning” after

he initially reported experiencing symptoms in August 2019. In these two later statements, he

continued to refer to his symptoms as beginning in “Spring 2019.” Conversely, Petitioner’s

physicians consistently described his CIDP as “progressive,” and not as relapsing-remitting,

including Petitioner’s diagnosing physician, Dr. Tobin. See Pet’r’s Ex. 9 at 18, 66; see also Pet’r’s

Ex. 14 at 89, 286; Pet’r’s Ex. 16 at 7, 290, 395, 445. As noted by the medical literature submitted

by Petitioner and argued in Petitioner’s own brief, “the course of CIDP can be varied and

presentations include relapsing-remitting, stepwise progressive, or gradually progressive.” Pet’r’s

Br. at 6 (citing Dyck & Tracy at 2). As such, Petitioner’s description of his symptoms in his brief

and affidavit is in contradiction with the reporting of his symptoms in the medical record.

As noted previously, special masters cannot make findings of fact based exclusively upon

statements of the petitioner. § 13(a)(1). And while medical records themselves cannot be presumed

to be complete and accurate, contemporaneous and consistent medical records are entitled to

greater weight when balanced against later contradictory statements. See Kirby, 997 F.3d at 1382–

83. Accordingly, I find that Petitioner’s assertion that he delayed the reporting of his symptoms

due to the relapsing-remitting nature of CIDP is not supported by the overall record and is therefore

insufficient to overcome his own prior statements to treaters that consistently identify his symptom

onset at Spring 2019.

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C. Delayed Onset Interval in CIDP Cases

Finally, Petitioner argued for a longer interval than the 42-day onset generally accepted by

the Program for causation-in-fact of vaccine-induced CIDP. Glassberg, 2009 WL 4641696, at *4;

Krusemark v. Sec’y of Health & Hum. Servs., No. 16-1593V, 2021 WL 6774576, at *10 (Fed. Cl.

Spec. Mstr. Dec. 29, 2021). However, Petitioner misconstrued both of the cases he relies on. In

Glassberg, the petitioner argued that her eight-year-old son had demonstrated onset of CIDP

symptoms within six weeks of receiving a flu vaccination, and not 75 days as indicated by the

petitioner’s medical records. 2009 WL 4641696, at *6. The court ultimately found for the

petitioner, because it held that onset did in fact begin within six weeks of the vaccination and not

75 days later as indicated by the medical record. Id.at *7. In this case, Petitioner’s argument that

Glassberg supports a longer interval for causation-in-fact is simply incorrect. The line of reasoning

relied upon by Petitioner, and which he submits as persuasive writing from the court, is in fact

summarized testimony from an expert witness and not an accurate application of the case holding.

In fact, the expert which Petitioner quotes in Glassberg expressly states that a period of 75 days

would be too long for the flu vaccine to have caused that petitioner’s CIDP. See id. at *6. This

directly undercuts the roughly 150-day period here.

The decision in Krusemark also does not stand for this proposition, as this was a decision

granting interim attorneys’ fees to a petitioner who brought a CIDP claim. 2021 WL 6774576, at

*10. Fees decisions use a lower standard when evaluating reasonable basis to determine whether

to award fees, which is expressly held to be “something less than the preponderant evidence

ultimately required to prevail on one’s vaccine-injury claim.” Chuisano v. Sec’y of Health & Hum.

Servs., 116 Fed. Cl. 276, 283 (2014); see also Cottingham v. Sec’y of Health & Hum. Servs., 971

F.3d 1337, 1346 (Fed. Cir. 2020) (holding that “more than a mere scintilla but less than a

preponderance of proof could provide sufficient grounds for a special master to find reasonable

basis.”). Further, the reference to Glassberg in Krusemark was to explain the nature of CIDP as a

“insidious[,] gradually increasing condition,” not to authoritatively or persuasively indicate a

longer onset period was justified in such cases. Krusemark, 2021 WL 6674576, at *10 (citing

Glassberg, 2009 WL 4641696, at *3). As such, I find these arguments to be insufficiently

persuasive to support Petitioner’s claim.

VI. Conclusion

After careful review of the record, I find that the record contains preponderant evidence

that Petitioner’s neuropathy symptoms began no earlier than approximately five months after his

October 26, 2018, flu vaccination. Petitioner has fourteen (14) days from the filing of this Ruling

to file a status report indicating how he wishes to proceed.

IT IS SO ORDERED.

s/Herbrina D. S. Young

Herbrina D. S. Young

Special Master

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