Bynum v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

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

JIM BYNUM, *

* No. 18-874V

Petitioner, * Special Master Christian J. Moran

*

v. *

* Filed: April 11, 2024

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

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

Milton Clay Ragsdale, IV and Allison Riley, Ragsdale, LLC, Birmingham, AL, for

Petitioner;

Madelyn Weeks, United States Dep’t of Justice, Washington, D.C., for

Respondent.

PUBLISHED DECISION DENYING COMPENSATION 1

At age 74, Jim Bynum, who had a complex medical history, received a

pneumococcal vaccine. His health worsened. He claims the vaccination harmed

him and asserts essentially two causes of action. First, the pneumococcal vaccine

significantly aggravated a previously undiagnosed Sjögren’s syndrome. Second,

the pneumococcal vaccine caused him to suffer lumbosacral radiculoplexus

neuropathy, another condition with which a treating doctor did not diagnose him

1

Because this Decision contains a reasoned explanation for the action taken in this case,

it must be made publicly accessible and will be posted on the United States Court of Federal

Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in

accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal

Management and Promotion of Electronic Government Services). This means the Decision will

be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the

parties have 14 days to identify and move to redact medical or other information, the disclosure

of which would constitute an unwarranted invasion of privacy. Any changes will appear in the

document posted on the website.

during treatment. The Secretary challenges Mr. Bynum’s entitlement to

compensation on several grounds.

To assist them, the parties retained experts. Mr. Bynum primarily relies

upon the opinions of David Younger, a neurologist. Mr. Bynum also advances the

opinion of G. Clement Dobbins, who earned a Ph.D. in neurobiology, but is not a

medical doctor. Finally, Mr. Bynum presents letters from a doctor who treated him

before and after the pneumococcal vaccination, Joshua Reams. The Secretary is

relying upon opinions from two people. They are Brian Callaghan, a neurologist,

and Christopher Mecoli, a rheumatologist.

When the written evidence was complete, the parties advocated through

briefs. Neither party requested a hearing.

Mr. Bynum is not entitled to compensation. As explained below, he has not

established that he suffers from the conditions for which he seeks compensation.

I. Qualifications of People Presenting Opinions

As a preliminary point, the credentials of the people offering opinions are set

forth.

A. Mr. Bynum’s Group 2

David Younger. David Younger earned a medical degree from Columbia

University in 1981. More recently, he has earned additional degrees in 2014 (a

master’s in public health), in 2016 (a Master of Science for epidemiology) and in

2020 (a Ph.D. in health policy management). Exhibit 74 (curriculum vitae) at 1.

Dr. Younger completed a residency in neurology in 1984. He also

completed various fellowships in 1986, 1987, and 1988. He became board-

certified in neurology and psychiatry in 1992. Id.

He has written more than 50 articles appearing in peer-reviewed journals.

He has also written books and book chapters. Id. at 5-20.

From February 2017 to February 2020, his license to practice medicine in

New York was suspended and the suspension was stayed. Exhibit 73. This

suspension followed Dr. Younger’s pleading guilty to one count of tax fraud.

2

Mr. Bynum did not submit any information about Dr. Reams’s qualifications.

2

When Dr. Younger submitted his first report dated October 22, 2022, he

stated that he had treated “10 patients with presumed primary microscopic

vasculitis and Sjogren’s syndrome over the past five years.” Exhibit 30 at 2.

G. Clement Dobbins. G. Clement Dobbins earned a Ph.D. in neurobiology

from the University of Alabama. Exhibit 71 (curriculum vitae) at 1. He has been a

postdoctoral fellow, focusing on virology, gene therapy, oncology, and

bioinformatics. Id. His curriculum vitae lists approximately ten articles he has

written for peer-reviewed journals. Id. He received grant funding to track “how

antigens expressed by SARS-CoV-2 and cytomegalovirus change within and

between patients over time and how these changes may trigger an altered immune

response in patients including those with immune dysfunction.” Exhibit 57

(report) at 1.

Dr. Dobbins was asked to discuss “how the pneumococcal vaccine given to

Mr. Bynum could lead to his symptoms.” Id. Dr. Dobbins did not offer any

opinions regarding diagnosis.

B. The Secretary’s Group

Brian Callaghan. Brian Callaghan earned a medical degree from the

University of Pennsylvania in 2004. Exhibit I (curriculum vitae) at 1. In the

following five years, Dr. Callaghan completed an internship, a residency in

neurology, and a fellowship in neuromuscular medicine. He is board-certified in

psychiatry and neurology as well as electrodiagnostic medicine. Id. His research

interests include the “evaluation of peripheral neuropathy” and “efficient

diagnostic testing in common neurologic disorders.” Id. at 2.

He has written more than 100 articles appearing in peer-reviewed journals.

Id. at 14-20. When Dr. Callaghan prepared his first report, dated July 12, 2021, he

represented that he treats “approximately 10 patients with vasculitic neuropathy

each year.” Exhibit A at 1.

Christopher Mecoli. Christopher Mecoli graduated from Rutgers

University with a medical degree in 2011. Exhibit D (curriculum vitae) at 1. In

the next few years, Dr. Mecoli completed an internship in medicine, a residency in

medicine, and a fellowship in rheumatology. Id. Dr. Mecoli is board-certified in

internal medicine (2014) and rheumatology (2017). Id. at 6.

He has written more than 25 articles, appearing in peer-reviewed journals.

Id. at 1-4. His research focuses “on the study of both idiopathic inflammatory

myopathies and systemic sclerosis.” Id. at 7.

3

In his first report, Dr. Mecoli stated that he “regularly evaluate[s] and

treat[s] patients with Sjogren’s syndrome and inflammatory arthritis, as well as

mimics of rheumatic disease.” Exhibit C at 1. Dr. Mecoli did not estimate the

number of patients he has treated.

II. Conditions Allegedly Affecting Mr. Bynum

A. Sjögren’s Syndrome

A basic definition of Sjögren’s syndrome is that it is a “chronic autoimmune,

rheumatic disorder most commonly characterized by dryness of eyes and mouth

due to lymphocytic infiltration of the lacrimal and salivary glandular tissues.”

Exhibit 42 (Fox) at 1.3 According to this medical textbook, “we still really do not

understand the underlying cause of SS [Sjögren’s syndrome]. Its epidemiologic

pattern suggests that both genetic and nongenetic factors (e.g. environmental or

epigenetic modifications) play a role.” Id. at 8.

Diagnosing Sjögren’s syndrome can be challenging as its presentation can

be “remarkably heterogeneous.” Exhibit C (Dr. Mecoli’s report) at 5; accord

Exhibit 43 (Vivino) at 21. 4 Diagnosis should involve “a comprehensive,

systematic, multidisciplinary evaluation.” Exhibit 42 (Fox) at 11. Because “no

universally accepted diagnostic criteria exist for Sjogren’s syndrome, many

clinicians utilize classification criteria to aid in guiding the diagnostic process.”

Exhibit C (Dr. Mecoli’s report) at 5.

Researchers have proposed various sets of diagnostic criteria, which have

had variable sensitivities and specificities. The currently predominant set of

criteria blend the best parts of previous criteria developed by the American College

of Rheumatology and the European League Against Rheumatism. Exhibit 43

(Vivino) at 27. A simplified summary of the criteria is:

1. Anti-SSA positivity or RF + ANA (≥ 1:320)

2. Positive lip biopsy [details omitted]

3

Robert Fox et al., “Sjögren’s syndrome: past, present, and future” in Sjögren’s

Syndrome: A Clinical Handbook (Frederick B. Vivino, 2020), filed as Exhibit 42.

4

Frederick Vivino, “Diagnosis and evaluation of Sjögren’s syndrome,” in Sjögren’s

Syndrome: A Clinical Handbook (Frederick B. Vivino, 2020), filed as Exhibit 43.

4

3. Objective evidence of dry eyes [details omitted]

4. Objective evidence of salivary gland involvement [details omitted].

Id. at 29 (table 2.7); see also Exhibit C at 5 (Dr. Mecoli discussing the diagnostic

criteria found in table 2.7). To qualify, a person must have at least three of these

criteria and no other explanation for the disease. Exhibit 43 (Vivino) at 29.

The first criterion “Anti-SSA positivity or RF + ANA” refers to different

types of antibodies. “RF” means rheumatoid factor. “ANA” means “anti-nuclear

antibodies.” “Anti-SSA” refers to Sjogren’s syndrome-associated antigen and is

sometimes known as “anti Ro” because the person in whom the antibodies were

first detected had the initials “Ro”. Exhibit 42 (Fox) at 6; see also Dorland’s at 99.

Another type of antibody that sometimes appears in the literature is called “Anti-

SSB” and is also known as “anti Lo.” Id.

“[A]ntibodies to SS-A may be present in ‘asymptomatic’ individuals many

years before any clinically detectable SS.” Exhibit 42 (Fox) at 6-7. “Furthermore,

. . . the finding of antibodies to SS-A in clinical screening does not always equate

to a diagnosis of SS.” Id. at 7.

“In about 80% of SS patients the disease begins with some form of the sicca

syndrome (from the Latin siccus meaning dry or thirsty) characterized by the

gradual onset of dryness of the eyes, mouth, and other body parts that develops

over months to years.” Exhibit 43 (Vinvio) at 22. “In the remaining 20% of cases,

an internal organ or extraglandular manifestation will predominate and sicca

symptoms may be minimal or nil at the time of initial evaluation. This atypical

presentation is particularly common among SS patients who present with

neurologic manifestations (Chapters 9, 10) of the disease.” Id.

Chapter 9 of this medical textbook, in turn, was written by Dr. Younger,

who is opining on behalf of Mr. Bynum. In this context, Dr. Younger wrote:

“Neuropathies in SS can be the presenting manifestations of the disease or occur

later in the course.” Exhibit 46 (Younger) at 153.5 In the remainder of this

chapter, Dr. Younger describes various disorders of the peripheral nervous system

5

David Younger, “Sjögren’s syndrome: peripheral and autonomic nervous system

involvement,” in Sjögren’s Syndrome: A Clinical Handbook (Frederick B. Vivino, 2020), filed

as Exhibit 46.

5

and the autonomic nervous system associated with Sjögren’s syndrome. However,

none of the various conditions are highlighted.

B. Vasculitic Peripheral Neuropathy6

“Vasculitis” means “inflammation of a blood or lymph vessel.” Dorland’s at

1996; accord Rocha v. Sec’y of Health & Hum. Servs., No. 16-241V, 2024 WL

752787 (Fed. Cl. Spec. Mstr. Feb. 1, 2024). Diseases caused by inflammation of

blood vessels are known as “vasculitides.” Exhibit 31 (Hadden) at 1567.7 “The

vasculitides may be triggered by immune reaction to certain antigens, including

infectious agents, possibly explaining the aetiology of post-immunisation

vasculitis. Due to the relative lack of collateral blood flow and high metabolic

demand, nerves are particularly susceptible to vasculitic injury.” Id. at 1567-68.

“Peripheral neuropathy is very common in the general population. The

clinical features which best distinguish [vasculitic peripheral neuropathy] from

other more common peripheral neuropathies are multifocality in time (‘stepwise’)

and space (multifocal or asymmetric pattern).” Exhibit 31 (Hadden) at 1573.

“Clinically, vasculitic neuropathies are usually painful and asymmetric, with

sensory, motor, and autonomic involvement.” Id. at 1567.

As part of the Brighton Collaboration, a group of researchers attempted to

establish diagnostic criteria for vasculitic peripheral neuropathy.8 They ended up

with sets of criteria, corresponding to definite (table 2), probable (table 3), and

suggestive (table 4). Id. at 1571-72; see also Resp’t’s Br. at 43 (discussing three

levels of confidence). “The Level 3 definition relies entirely on the typical clinical

features of vasculitic neuropathy. . . . First, there should be evidence of

abnormality of the peripheral nervous system . . . . Second, the clinical features of

6

The parties’ briefs regarding vasculitic peripheral neuropathy could have been clearer.

7

Robert Hadden et al., “Vasculitic peripheral neuropathy: Case definition and guidelines

for collection, analysis, and presentation of immunization safety data,” 35 Vaccine 1567 (2017),

filed as Exhibit 31. Dr. Younger edited a book called “The Vasculitides.” See Exhibit 37.

8

The Brighton Collaboration is an “international group of vaccine safety reports [and]

[o]ne of the Collaboration’s roles is establishing standard case definitions for various illnesses

and disorders that are temporally related to vaccinations, known as ‘adverse events following

immunization.’” Tompkins v. Sec’y of Health & Hum. Servs., No. 10-261V, 2013 WL 3498652

(Fed. Cl. Spec. Mstr. June 21, 2013), mot. for rev. denied, 117 Fed. Cl. 713 (2014).

6

the neuropathy should be those with the greatest positive predictive value for VPN

relative to other neuropathies.” Id. at 1572.

The term “vasculitic peripheral neuropathy” encompasses various subtypes.

See Exhibit 31 (Hadden) at 1571. One subtype is known as lumbrosacral

radiculoplexus neuropathy. Id.; see also Exhibit 37 (Younger) at 250.

Lumbrosacral radiculoplexus neuropathy can be diabetic or nondiabetic in origin.

Regardless, they usually involve “the distal and proximal limbs asymmetrically.

They begin focally and unilaterally, but often become widespread and bilateral.

These diseases affect lumbrosacral roots, lumbrosacral plesux, and lower limb

peripheral nerves.” Exhibit A-2 (Gwathmey) at 72. 9 Electrodiagnostic studies

“characteristically show acute-to-subacute axonal loss of sensory and motor fibres,

frequently in a patchy, multifocal distribution. Electrodiagnostic findings that are

most supportive of a diagnosis of vasculitic neuropathy are those indicative of

asymmetrical or non-length dependent patterns of axonal neuropathy.” Id. at 73.

III. Events in Mr. Bynum’s Life

Mr. Bynum’s medical history is divided into two periods. The first period

concerns his health before the allegedly casual vaccination. The second period

concerns his health after the allegedly casual vaccination.

A. Before Vaccination

For Mr. Bynum’s health before vaccination, the parties have different

perspectives. Mr. Bynum recounts evidence regarding his pre-vaccination health

in a single paragraph. Pet’r’s Br. at 1. In contrast, the Secretary’s summary runs

approximately four pages. Resp’t’s Br. at 2-5.

Mr. Bynum was born in 1941. Exhibit 3 at 1. According to histories created

in 2013, 2015, and 2018, Mr. Bynum developed rheumatoid arthritis in the 1960’s

and diabetes in the 1980’s. Exhibit 5 at 78, Exhibit 21 at 6, Exhibit 23 at 28. Mr.

Bynum agrees that he suffered from these problems, although in his view, they

were “under control and not severe or disabling pre-vaccination.” Pet’r’s Br. at 1.

In January 2013, Mr. Bynum saw a rheumatologist, Aymen Kenawy, for the

first time. Exhibit 23 at 28. Mr. Bynum reported a series of problems, including

muscle aches, night sweats, dry eyes, and dry mouth. Id. at 30. The chief

complaint was diffuse joint pain. Id. at 28. On physical examination, Dr. Kenawy

9

Kelly Gwathmey et al., “Vasculitic neuropathies,” 13 Lancet Neurol 67 (2014).

7

detected limited range of motion and tenderness. Id. at 31. Dr. Kenawy’s

examination of Mr. Bynum’s eyes and mouth did not reveal any abnormalities. Id.

Dr. Kenawy’s “working diagnoses include (but are not limited to)

osteoarthritis, inflammatory arthritis and chronic widespread pain syndrome.” Id.

at 31. He ordered ultrasounds of various joints and prescribed Flexcin. Id.; see

also Exhibit 39 (Dr. Younger’s report) at 1.

In addition, Dr. Kenawy ordered an array of blood tests. Many tests

returned an expected or normal result, such as a test for anti-nuclear antibodies.

Exhibit 31 at 25-27; see also Exhibit C (Dr. Mecoli’s report) at 2. One relevant

positive test was a test for SS-A antibodies. This test returned a result of 1.0 and

the expected result is to be lower than 1.0. Exhibit 31 at 44. Dr. Mecoli

commented that “While this technically is above the upper limit of normal, it is not

considered a robust, high-titer autoantibody level.” Exhibit C at 6. Although Dr.

Younger mentioned the positive SS-A result (Exhibit 39 at 2), Dr. Younger did not

refer to this positive result as supporting Dr. Younger’s diagnosis of Sjögren’s

syndrome.

A return visit with Dr. Kenawy occurred on March 6, 2013. Exhibit 23 at

23. A purpose was to review the labs and ultrasounds. Id. In this appointment, as

in the January 10, 2013 appointment, Mr. Bynum reported muscle aches and joint

pain. Id. at 25. However, on March 6, 2013, Mr. Bynum denied having dry eyes

and denied having dry mouth. Id. Dr. Kenawy assessed Mr. Bynum as suffering

from an unspecified inflammatory polyarthropathy and prescribed Enbrel. Id. at

28. Dr. Kenawy did not diagnose Mr. Bynum as suffering from Sjögren’s

syndrome.

After the March 6, 2013 appointment, Mr. Bynum returned for

rheumatological care with Dr. Kenawy five additional times. Exhibit 23 at 4-22.

He denied having dry eyes and dry mouth consistently.

The appointments with Dr. Kenawy overlapped with appointments with a

primary care doctor, Sanders McKee. See Exhibit 10. However, these records do

not affect whether Mr. Bynum is entitled to compensation. See Exhibit 39 (Dr.

Younger’s report) at 1-2 (omitting any discussion of records from Dr. McKee).

Mr. Bynum had his first appointment with a different primary care doctor,

Dr. Reams, on June 5, 2014. Exhibit 5 at 3. Dr. Reams worked for Bay Medical

Sacred Heart. The chief complaint was a cough.

8

Between June 5, 2014 and June 8, 2015, Mr. Bynum saw Dr. Reams for a

variety of problems across 11 visits. Exhibit 5 at 3-57. There are no notations

about Mr. Bynum complaining of dry eyes or dry mouth. None of Dr. Reams’s

records mention the positive SS-A test. Dr. Reams did not diagnose Mr. Bynum as

suffering from Sjögren’s syndrome.

On June 25, 2015, Mr. Bynum was riding his motorcycle without a helmet

and fell off it. Exhibit 4 at 3-4 (record created on June 30, 2015). Mr. Bynum

reported that he did not hit his head and that he did not lose consciousness. Id.

B. Vaccination and Thereafter

1. June through October 2015

Mr. Bynum received the allegedly causal pneumococcal vaccine on June 26,

2015. Exhibit 1 at 3. (Some medical records refer to this pneumococcal vaccine as

“PCV 13,” or by its brand name, Prevnar). 10

Four days later, Mr. Bynum sought care from a different office of Bay

Medical Sacred Heart, where a doctor other than Dr. Reams saw him. Mr. Bynum

told Dr. Brian Shaheen about his motorcycle accident. In addition, Mr. Bynum

stated that he had received pneumovax and “ever since then has not felt well.”

Exhibit 5 at 58. Specific problems included “dizziness for four days,”

“unstability,” and “headaches.” Id. Dr. Shaheen stated that his findings of

generalized weakness and quavering voice were not specific. Id. at 62. He

worried that Mr. Bynum might have “Guillain Barré syndrome, early encephalitis

[or a] metabolic disorder” and sent him directly to the emergency room. Id.

Mr. Bynum did not go to the emergency room. Exhibit 5 at 64. According

to a statement signed under penalty of perjury in 2018 by Mr. Bynum’s then

girlfriend, Mr. Bynum did not drive to the emergency room because of his “mental

confusion and illness.” Exhibit 18 (statement of Melinda Leslie) ¶ 6.

Ms. Leslie averred that over the next several weeks, Mr. Bynum “did not

improve.” Id. ¶ 7. He was weak, had no appetite, and was losing weight. He “was

not mentally alert and at time barely responsive.” Id. “The sudden deterioration in

10

References to Mr. Bynum receiving a pneumovax vaccine are incorrect. The Vaccine

Program does not compensate people for harm caused by the pneumovax vaccine. Byrd v. Sec’y

of Health & Hum. Servs., 142 Fed. Cl. 79, 84 (2019), aff’d, 778 Fed. Appx. 924 (Fed. Cir. 2019).

9

[Mr. Bynum’s] physical and mental health that started shortly after the vaccination

was astonishing to [Ms. Leslie].” Id.

Some of Ms. Leslie’s recollections match a report that Mr. Bynum provided

to Dr. Reams on July 27, 2015, approximately one month after the vaccination.

Mr. Bynum presented to Dr. Reams to discuss “side effects from Prevnar vaccine.”

Exhibit 5 at 64. Mr. Bynum informed Dr. Reams that he has been having night

sweats, fatigued, and not eating much. Mr. Bynum also reported generalized

weakness. He also said he is “somewhat better now.” Id.

Dr. Reams assessed Mr. Bynum as having two conditions: fatigue and

confusion. Under fatigue, Dr. Reams wrote: “This may all be a reaction to vaccine

but we need to rule out other issues.” Exhibit 5 at 67. Dr. Reams ordered a series

of labs. Id. Whether Mr. Bynum was tested is not readily apparent.

Over the next week, Mr. Bynum visited an emergency room twice. On July

30, 2015, Mr. Bynum reported having a cough, chills, fever, and myalgias. Exhibit

6 at 5-6. The doctor diagnosed him with bronchitis and prescribed medications.

On August 4, 2015, Mr. Bynum reported problems, including decreased

responsiveness. Id. at 15-16. He was given Narcan and became more alert. The

doctor stated that Mr. Bynum had taken too much of the medication that had been

prescribed a few days earlier.

Mr. Bynum’s next medical appointment was with Dr. Reams on August 27,

2015. Exhibit 5 at 69. Mr. Bynum complained about chronic fatigue, starting six

weeks earlier. Mr. Bynum also reported joint pain. For the fatigue, Dr. Reams

recommended adjusting a medication, gabapentin. For the joint pain, Dr. Reams

gave a Kenalog shot. Id. at 71.

Although not documented in the August 27, 2015 record, it appears that Dr.

Reams referred Mr. Bynum to a neurologist, whom he saw on August 31, 2015.

Exhibit 7 at 23. Mr. Bynum told Dr. George Barrio that he:

has been typically in a normal state of health until June after a Prevnar

vaccination and some time before a viral infection, in which he started

developing significant issues with dizziness, headache, slight altered

mental status, dysphagia, tremor with difficulty with coordination that

have all been slightly progressive since the onset.

Id. As part of Dr. Barrio’s review of systems, Dr. Barrio noted Mr. Bynum

reported “blurred vision, dry eyes, eye pain, difficulty swallowing and pain when

swallowing.” Id. at 24. On examination, Dr. Barrio detected a “slightly increased

10

tone.” Id. at 25. A sensory examination revealed: “Length-dependent loss to

pinprick, temperature, and vibration. Reflexes trace in uppers, absent in lowers.”

Id. Dr. Barrio’s impression included neuropathy, among other problems. Dr.

Barrio ordered three types of tests---an EEG, a MRI, and electromyography/nerve

conduction studies. Id. at 25.

The first test, the EEG, was normal. Exhibit 7 at 22 (Sep. 10, 2015). The

second test, a brain MRI, showed some abnormal focal areas. Id. at 20 (Sep. 24,

2015). However, Mr. Bynum has not suggested that the brain MRI contributes to

the dispute over diagnosis. See Pet’r’s Br.

The third set of tests, the EMG / NCS, are more consequential. See Pet’r’s

Br. at 5. One set of EMG / NCS tests were performed on Mr. Bynum’s upper

extremities. The results suggested “mild chronic multilevel cervical

radiculopathy.” Exhibit 7 at 15 (Oct. 1, 2015). The other set of EMG / NCS tests

were performed on Mr. Bynum’s lower extremities and were abnormal. The

results were “highly suggestive of peripheral neuropathy. . . . The above electro

diagnostic study also reveals evidence of moderate chronic multilevel lumbosacral

radiculopathy on the right and left.” Id. at 10 (Oct. 15, 2015).

When this testing was complete, Mr. Bynum returned to Dr. Barrio. He

reported “there are no significant changes, but still is adamant regarding variety of

the symptoms after his Prevnar immunization.” Exhibit 7 at 5 (Oct. 23, 2015).

The results of a neurologic examination were similar to the results on August 31,

2015. In Dr. Barrio’s plan, he specifically wrote about various problems and tests,

but not the lower extremity MRI. See id. at 7. Dr. Barrio anticipated that Mr.

Bynum would return in four weeks. Id. However, it appears that Mr. Bynum next

saw Dr. Barrio nearly two years later. See Exhibit 11 at 10 (report from Aug. 23,

2017).

2. November 2015 through 2016

Although Mr. Bynum stopped seeing Dr. Barrio, Mr. Bynum continued to

see other doctors, primarily Dr. Reams, throughout the remainder of 2015 and

2016. There were approximately 10 visits. For details, see Resp’t’s Br. at 10-11.

These records do not memorialize any complaints about dry mouth or dry eyes.

See Exhibit 5 at 78-135. Similarly, Dr. Reams’s notes do not suggest that Mr.

Bynum suffered from Sjögren’s syndrome. However, on December 4, 2015, Dr.

Reams informed the Vaccine Adverse Event Reporting System that Mr. Bynum

“received Prevnar 13 on 6/26/15. The next day or so he began having pain in

joints all over his body, fatigue, weakness, irritability + hypersomnolence. He

11

continues to have these symptoms.” Exhibit 28 at 1; accord Exhibit 5 at 90-92 (Dr.

Reams’s December 1, 2015 record stating that Mr. Bynum’s symptoms of

weakness, increased pain in his hips and legs, increased somnolence and loss of

appetite “are best explained by an adverse [reaction] to Prevnar given on 6/26/15”).

In his brief, Mr. Bynum points to a gastroenterologist’s record from this

time. Pet’r’s Br. at 2. On November 16, 2015, Mr. Bynum saw Shilpa Reddy.

Mr. Bynum reported difficulty with swallowing that began gradually. Exhibit 24

at 4. Dr. Reddy recommended an endoscopy to evaluate for esophageal structural

abnormality. Id. at 6. Whether Mr. Bynum underwent an endoscopy is not clear. 11

3. 2017 through 2022

In 2017, Mr. Bynum returned to Dr. McKee for the first time in

approximately three years. Exhibit 38 at 4 (May 25, 2017). Dr. McKee

investigated Mr. Bynum’s report of a weight loss.

Later in 2017, as mentioned earlier, Mr. Bynum saw a neurologist, Dr.

Barrio, for the first time in approximately two years. Exhibit 11 at 10 (Aug. 23,

2017). In the next appointment, Dr. Barrio recommended an EMG / NCS. Id. at 6.

The EMG / NCS took place on October 3, 2017. Exhibit 14 at 15. For Mr.

Bynum’s lower extremities, the EMG / NCS showed “a severe length-dependent

peripheral neuropathy that appears to have more axonal greater than demyelinating

features.” Id. “Clinical correlation is strongly advised.” Id.

In a follow-up appointment, Mr. Bynum saw Stephen Johnson, ARNP-FNP,

on October 20, 2017. Id. at 9. In a review of systems, Mr. Bynum denied dry

mouth. Id. at 10. Mr. Johnson planned “to do some extensive lab work for further

evaluation. . . . He is going to see Dr. Barrio next visit.” Id. at 11. However, the

results of any additional testing were not provided. Mr. Bynum saw Dr. Barrio on

November 11, 2017, and recommended a follow-up appointment in four weeks.

Id. at 5. It appears that Mr. Bynum did not see Dr. Barrio again. See Resp’t’s Br.

at 13.

In 2018 and 2019, Mr. Bynum sought care from Dr. McKee for a variety of

problems. See Exhibit 13 and Exhibit 27. During these appointments, it appears

that he did not report dry mouth or dry eyes. See Exhibit 13 at 27-36, passim;

11

It appears that Mr. Bynum reported that he had “upper endoscopy;” however, it is

unclear whether he actually underwent the procedure. See Exhibit 24 at 8.

12

Exhibit 27. Diagnoses included various medical conditions but not Sjögren’s

syndrome. In November 2019, Mr. Bynum had an appointment with Dr. Reams

for the first time in approximately three years. Exhibit 76 at 57. Mr. Bynum

complained about an upper respiratory infection. Id. Records from Dr. Reams

continue through 2022. During these visits, it appears that Mr. Bynum did not

report dry mouth or dry eyes nor is there any mention of Sjögren’s syndrome.

Exhibit 76, passim.

IV. Procedural History

Represented by Attorney M. Clay Ragsdale, Mr. Bynum started this

litigation by filing his petition on June 20, 2018. He periodically filed medical

records and other factual materials.

The Secretary reviewed this evidence and recommended that compensation

be denied. Resp’t’s Rep., filed June 19, 2019. The Secretary asserted that Mr.

Bynum’s “allegation of a number of symptoms he purportedly experienced

following his vaccination does not amount to a compensable, medically-recognized

injury.” Id. at 12. The Secretary argued: “Assuming, arguendo, that petitioner can

show by preponderant evidence that he suffered from a compensable, medically-

recognized injury and that he suffered the sequela of that injury for more than six

months, he also must establish by preponderant evidence that the Prevnar 13

vaccine was the “legal cause” for his injury under the Althen test . . .” Id. The

Secretary stated that Mr. Bynum did not file any expert reports in support of his

petition. Id. at 13.

To facilitate the process of obtaining useful reports from experts, a set of

instructions were proposed. Order, issued Oct. 31, 2019. After neither party

interposed any objections, the draft instructions became final on November 22,

2019.

After receiving multiple enlargements of time, Mr. Bynum submitted a

report from Dr. Younger on October 23, 2020. Exhibit 30. Dr. Younger proposed

that Mr. Bynum suffered from “autoimmune lumbosacral radiculoplexus

neuropathy due to microscopic vasculitis.” Id. at 4. Dr. Younger did not suggest

that Mr. Bynum was affected by Sjögren’s syndrome. See id. Dr. Younger opined

that the onset of the autoimmune lumbosacral radiculoplexus neuropathy was

within 48 hours of the vaccination. Id. at 7. However, Dr. Younger did not cite

the medical record corresponding to this proposed onset. To explain how the

pneumococcal vaccine could cause autoimmune lumbosacral radiculoplexus

13

neuropathy, Dr. Younger referred to polyclonal B cells. Id. at 4-5. However, the

explanation for this theory was relatively thin.

A status conference was held on November 4, 2020. Some of the

deficiencies with Dr. Younger’s report were discussed. Mr. Bynum planned to

obtain a supplemental report.

The supplemental report from Dr. Younger was filed on December 14, 2020

as Exhibit 39. Dr. Younger opined that before the vaccination, Mr. Bynum was

suffering from an incomplete or undeveloped forme fruste Sjögren’s syndrome.

Dr. Younger further opined that the “immune challenge initiated by the vaccine

brought forth and resulted in a more complete manifestation of his underlying

forme fruste primary SS and vasculitic peripheral neuropathy.” Exhibit 39 at 4.

Dr. Younger stated that evidence of the development of SS was apparent within

approximately 48 hours of the vaccination. Id. at 6. Consistent with his previous

report, Dr. Younger referenced polyclonal B-cell activation and cited an article by

Brauner. Id.

This second report adequately complied with the expert instructions. Thus,

the Secretary was directed to respond. As noted above, the Secretary presented

reports from Dr. Callaghan and Dr. Mecoli, who addressed different aspects of Dr.

Younger’s reports.

Dr. Callaghan focused on Dr. Younger’s opinion that Mr. Bynum suffered

from lumbosacral radiculoplexus neuropathy. In Dr. Callaghan’s view, “there is

no evidence of this based on the medical record.” Exhibit A at 5. If Mr. Bynum

did suffer from lumbosacral radiculoplexus neuropathy, “diabetes would be the

likely cause.” Id. at 6. Dr. Callaghan also disagreed with Dr. Younger’s opinion

regarding onset. To Dr. Callaghan, Mr. Bynum had many symptoms for years

before the vaccination. Id. Finally, with respect to causation, Dr. Callaghan

quoted the Hadden article, which stated: “no causal relationship between

immunisation and systemic or nonsystemic vasculitic neuropathy has been

established.” Id., quoting Exhibit 31 at 1568. 12

Dr. Mecoli addressed the other aspect to Dr. Younger’s opinion, that the

pneumococcal vaccine contributed to Mr. Bynum’s developing Sjögren’s

syndrome. Dr. Mecoli stated that from “the available data, the diagnosis of

12

Dr. Callaghan identified the Hadden article as reference 3 and the Secretary filed the

Hadden article as Exhibit A, tab 3. For the sake of consistency, this decision cites the Hadden

article as Exhibit 31.

14

Sjogren’s syndrome (either pre- or post-Prevnar vaccination), is questionable.”

Exhibit C at 5. Dr. Mecoli elaborated: “There is no positive lip biopsy, no

objective evidence of dry eye, and no objective evidence of salivary gland

involvement. In the present case, not only does the diagnosis of Sjogren’s appear

to be based on non-specific symptoms - myalgia, fatigue, cough, weakness, weight

loss (Ex 39 [Dr. Younger’s report] p6), but these symptoms existed prior to the

Prevnar vaccination.” Id. at 6. Nonetheless, Dr. Mecoli recognized that Mr.

Bynum “does appear to have new and/or worsening symptoms post-Prevnar

vaccine.” Id. at 8. In addition, Dr. Mecoli disputed the opinion that the

pneumococcal vaccine can cause Sjögren’s syndrome. Id. at 8-9.

Mr. Bynum’s response to these reports from two experts was to present

reports from three people. First, Mr. Bynum filed another report from Dr.

Younger. He generally defended the opinions that he previously expressed.

Exhibit 51. Next, Mr. Bynum submitted a letter from Dr. Reams, who recounted

his treatment of Mr. Bynum over the years and opined that any condition from

before the vaccination (such as diabetes) did not cause the symptoms after the

vaccination. Exhibit 56. Finally, Mr. Bynum filed a report from Dr. Dobbins. Dr.

Dobbins declared: “There is much data to support Dr. Younger’s proposition that

Mr. Bynum’s symptoms are a result of hyperreactivity of B Cells initiated by the

PCV13 vaccine.” Exhibit 57 at 3.

The Secretary obtained a report from Dr. Callaghan and Dr. Mecoli. Dr.

Callaghan generally defended his opinions, including his challenge to the

proposition that Mr. Bynum suffered from vasculitis or lumbrosacral

radiculoplexus neuropathy. Exhibit E.

Dr. Mecoli, similarly, maintained his previously expressed opinions. His

second report began: “In my initial report, I wrote that the diagnosis of Sjogren’s

syndrome was questionable. I will be more firm in this rebuttal report: The

evidence the petitioner has Sjogren’s syndrome is extremely weak.” Exhibit F at 1.

With respect to Dr. Dobbins’s assertion that “There is much evidence to support

Dr. Younger’s proposition that Mr. Bynum’s symptoms are a result of hyper-

reactivity of B Cells initiated by the PCV13 vaccine,” Dr. Mecoli responded “no

such evidence is presented.” Id. at 3.

The last report from a doctor was a second letter from Dr. Reams. Exhibit

75. Dr. Reams began his letter stating that he reviewed his chart for Mr. Bynum

and the report from David Younger that Mr. Ragsdale had provided to him. Id. at

1. Dr. Reams wrote: “Mr. Bynum’s symptoms and course of events post-

vaccination do strongly suggest that he developed an autoimmune process as a

15

result of the Prevnar vaccine. Mr. Bynum’s abrupt change was followed by a

progressively deteriorating neurologic decline.” Id. Dr. Reams also wrote: “Dr.

Younger’s opinion of autoimmune vasculopathy, PNS, and Sjogrens is supported

by Mr. Bynum’s symptomology and course.” 13

After the experts disclosed their opinions and the bases for their opinions,

the next step was for the parties to argue their cases. Order, issued June 27, 2022.

As part of this process, Mr. Bynum submitted updated medical records. Exhibits

76-77. He filed his brief and amended petition on November 1, 2022. The

Secretary responded on January 6, 2023. Mr. Bynum replied on February 6, 2023.

As part of the briefing process, Mr. Bynum did “not request a hearing.”

Pet’r’s Br. at 31. Mr. Bynum enjoyed multiple opportunities to present a

persuasive case. After Dr. Younger’s first report was found to be deficient, he was

given a chance to improve it. Order, issued Nov. 5, 2020. Then, after the

Secretary’s experts critiqued the second report, Mr. Bynum had an opportunity to

respond to their points. See Order, issued July 21, 2021. Likewise, Mr. Bynum

had the last word in the briefs. See Pet’r’s Reply, filed Feb. 6, 2023. Because both

parties have had a fair opportunity to present their evidence and their arguments,

an adjudication based upon the papers is appropriate. See Kreizenbeck v. Sec’y of

Health & Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2018).

V. Standards for Adjudication

A petitioner is required to establish his case by a preponderance of the

evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence

standard requires a “trier of fact to believe that the existence of a fact is more

probable than its nonexistence before [he] may find in favor of the party who has

the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of

Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations

omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &

Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).

Distinguishing between “preponderant evidence” and “medical certainty” is

important because a special master should not impose an evidentiary burden that is

too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.

Cir. 2009) (reversing special master’s decision that petitioners were not entitled to

compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357

13

In this context, “PNS” probably refers to peripheral nervous system.

16

(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.

Cir. 1993) (disagreeing with dissenting judge’s contention that the special master

confused preponderance of the evidence with medical certainty).

One element of a petitioner’s case is to establish with preponderant evidence

that the vaccinee suffers from the condition that a vaccine allegedly caused.

Broekelschen v. Sec’y of Health and Hum. Servs., 618 F.3d 1339, 1346 (Fed. Cir.

2010). When a petitioner does not satisfactorily establish a relevant diagnosis,

special masters are not required to address whether the vaccine caused the injury.

Lombardi v. Sec’y of Health & Hum. Servs., 656 F.3d 1343, 1353 (Fed. Cir.

2011). In considering whether a vaccinee suffers from a particular condition, a

special master should consider all evidence. Within the field of the entire record,

the opinions of treating doctors often stand out. Lombardi, 656 F.3d at 1353-54

(ruling that a special master was not arbitrary in rejecting a neurologic diagnosis

offered by an expert retained in the litigation that a treating neurologist did not

find); D’Angiolini v. Sec’y of Health & Hum. Servs., No. 99-578V, 2014 WL

1678145, at *24 (Fed. Cl. Spec. Mstr. Mar. 27, 2014) (indicating that the views of

a treating doctor on diagnosis are “almost definitive”), mot. for rev. denied, 122

Fed. Cl. 86 (2015), aff’d without op., 645 F. App’x 1002 (Fed. Cir. 2016).

VI. Analysis

Mr. Bynum alleges the pneumococcal vaccine contributed to his developing

two different conditions, Sjögren’s syndrome and lumbrosacral radiculoplexus

neuropathy. Am. Pet., filed Nov. 1, 2022, ¶¶ 14-15. The separate evaluations

follow.

A. Sjögren’s syndrome

Although Dr. Younger asserted that Mr. Bynum developed Sjögren’s

syndrome, Mr. Bynum did not substantiate that opinion persuasively. Two

potential sources of information include treatment reports and opinions expressed

during litigation.

1. Treatment Reports

A treating doctor has not diagnosed Mr. Bynum as suffering from Sjögren’s

syndrome. For example, Dr. Mecoli noted that Mr. Bynum’s rheumatologist, Dr.

Kenawy, did not mention “the possibility of Sjogren’s syndrome, either associated

with an inflammatory arthritis or as a separate, distinct entity.” Exhibit C at 7.

Although Dr. Younger responded to Dr. Mecoli’s report, Dr. Younger did not

identify any treating doctor who agreed with his opinion that Mr. Bynum suffered

17

from Sjögren’s syndrome. See Exhibit 51 at 3-4. Similarly, the Secretary noted

the lack of diagnosis from treating doctors, except for Dr. Reams (see Resp’t’s Br.

at 25-26), yet Mr. Bynum does not contradict this assertion. See Pet’r’s Reply at

2-10.

Throughout the years that Dr. Reams saw Mr. Bynum, Dr. Reams proposed

a variety of diagnoses, including some that are not controversial like diabetes.

Across this span of records, Dr. Reams did not suggest that Mr. Bynum suffered

from Sjögren’s syndrome.

Despite this lack of diagnosis, Dr. Reams endorsed Dr. Younger’s proposed

diagnosis of Sjögren’s syndrome in a letter to Mr. Bynum’s attorney. Dr. Reams

wrote: “Although I am not a neurologist or a rheumatologist, I have treated

hundreds of patients with possible or suspected autoimmune disorders. . . . Dr.

Younger’s opinion of . . . [Sjögren’s] is supported by Mr. Bynum’s symptomology

and course.” Exhibit 75.

Multiple factors reduce the persuasive value of Dr. Reams’s February 7,

2022 letter. First, Dr. Reams did not propose that Mr. Bynum suffered from

Sjögren’s syndrome in any treatment record. Dr. Reams has not explained the

inconsistency between how he treated Mr. Bynum and what he is saying in

litigation. See Lombardi, 656 F.3d at 1355 (ruling that a special master was not

arbitrary in declining to credit a conclusory letter from a treating physician that did

not explain the basis for a diagnosis); Townsend v. Sec’y of Health & Hum. Servs.,

No. 14-266, 2024 WL 1081358 (Fed. Cl. 2024) (ruling that a special master was

not arbitrary in declining to credit a letter from a treater that did not explain

foundation for causation analysis); Ruiz v. Sec’y of Health & Hum. Servs., No. 02-

156V, 2007 WL 5161754, at *14 (Fed. Cl. 2007) (ruling that a special master was

not arbitrary in declining to credit a treating doctor’s letter that was written five

years later and did not match the treatment records); Frette v. Sec’y of Health &

Hum. Servs., No. 14-1105V, 2017 WL 7421013, at *14 (Fed. Cl. Spec. Mstr. Dec.

29, 2017) (declining to credit a statement from treating doctor about events that

allegedly happened two years and were not charted). Second, Dr. Reams

supported Dr. Younger’s opinion without the benefit of reviewing the opinion from

Dr. Mecoli. Mr. Ragsdale’s providing reports from only one of the two experts

who opined on the Sjögren’s syndrome diagnosis means that Dr. Reams has

incomplete information. Third, Dr. Reams admits that he is not a rheumatologist.

Thus, his ability to diagnose a rheumatological disorder seems at least unclear. At

the end of the day, Dr. Reams’s February 7, 2022 letter does not add much to the

case. He essentially is deferring to Dr. Younger’s opinion on diagnosis without

explaining why Dr. Younger is persuasive.

18

Accordingly, the statements of treating doctors do not persuasively establish

that Mr. Bynum suffered from Sjögren’s syndrome. If anything, this type of

evidence tends to show that Mr. Bynum did not have Sjögren’s syndrome. Thus,

for Mr. Bynum to carry his burden regarding diagnosis, he needs to rely upon

opinions from the doctor he retained in the litigation.

2. Opinions from People Retained in the Litigation

Mr. Bynum advances the Dr. Younger’s opinion as a basis for finding that

he suffered from Sjögren’s syndrome. Pet’r’s Br. at 19. However, Dr. Younger is

not persuasive.

Preliminarily, Dr. Younger’s opinion on diagnosis changed without

explanation. In Dr. Younger’s first report, he was asked to describe the condition

caused by the pneumococcal vaccination. Exhibit 30 at 3 (question 9); see also

Instructions, issued Nov. 22, 2019. Dr. Younger answered: “Mr. Bynum

developed autoimmune lumbosacral radiculoplexus neuropathy due to microscopic

vasculitis as a response to PCV13 vaccination.” Exhibit 30 at 4. Dr. Younger did

not mention Sjögren’s syndrome in this first report. Dr. Younger was called upon

to develop his opinions. Order, issued Nov. 5, 2020.

In the second report, Dr. Younger added a diagnosis of Sjögren’s syndrome.

He wrote: “Mr. Bynum probably had pre-existing forme fruste primary Sjögren’s

syndrome.” Exhibit 39 at 4. Dr. Younger did not explain that he came to

recognize that Mr. Bynum suffered from Sjögren’s syndrome in his December 14,

2020 report when he did not present the same opinion in his October 22, 2020

report. An explanation from Dr. Younger about this addition to his diagnosis

might have enhanced the persuasiveness of Dr. Younger’s opinion.

More importantly, even when Dr. Younger was disclosing an opinion that

Mr. Bynum suffered from Sjögren’s syndrome, Dr. Younger’s presentation was

vague. The November 22, 2019 Instructions direct experts to describe the

“diagnostic criteria” for any relevant condition. ¶ 4.b. Yet, Dr. Younger’s second

report does not include any diagnostic criteria for Sjögren’s syndrome. See Exhibit

39; see also Resp’t’s Br. at 23. Without this disclosure about the criteria relevant

to Dr. Younger, finding Dr. Younger’s opinion on diagnosis to be reliable is

challenging. See Orloski v. Sec’y of Health & Hum. Servs., 147 Fed. Cl. 713, 725

(2020) (ruling that special master was not arbitrary in not crediting the statement of

a treating doctor who did not provide diagnostic criteria), aff’d in non-precedential

op., 839 F. App’x 538 (Fed. Cir. 2021).

19

Dr. Younger relied upon the following symptoms and signs: fever, myalgia,

extreme fatigue, cough, weakness, dysphagia, and the development of a

neuropathy. Exhibit 39 at 5; Exhibit 51 at 3; see also Pet’r’s Br. at 30. Dr.

Younger emphasizes that approximately 20 percent of Sjögren’s syndrome cases

begin with neurologic problems with the reports of dry eyes / dry mouth following.

Exhibit 39 at 4-5. Dr. Younger does not point to the positive SS-A antibody test as

supporting the diagnosis of Sjögren’s syndrome.

Dr. Mecoli convincingly showed that Dr. Younger’s opinion regarding

diagnosis is mistaken. 14 Problems like myalgia, fatigue, cough, weakness, and

weight loss are “non-specific.” Exhibit C at 6.

Non-specific signs and symptoms such as fatigue, fever, dysphagia, and

cough cannot be used as justification for a diagnosis of Sjogren’s. They

can be ‘supportive of’ or ‘consistent with’, but they, by themselves or

even in combination, do not serve as the foundation for the diagnosis.

They simply do not have enough specificity.

Exhibit F at 2. As to the criteria that are recognized as useful in identifying people

with Sjögren’s syndrome, Dr. Mecoli accurately stated: “There is no positive lip

biopsy, no objective evidence of dry eye, and no objective evidence of salivary

gland involvement.” Exhibit C at 6. Dr. Mecoli also addressed why the slightly

positive SS-A antibody test was not diagnostic. Id.

Dr. Mecoli also responded to Dr. Younger’s point that not everyone with

Sjögren’s syndrome will have dryness on their initial evaluation, agreeing with Dr.

Younger. But, Dr. Mecoli demonstrated the limited value of this point. “[W]e

have the benefit of 5+ years of treatment records since the patient received the

Prevnar vaccination. During this time span, the patient has not endorsed any sicca

or has not undergone any testing for Sjogren’s syndrome to my knowledge.”

Exhibit C. At best, Mr. Bynum identified one medical record from 2017 in which

Mr. Bynum reported dry mouth and difficulty swallowing. Pet’r’s Reply at 6,

citing Exhibit 11 at 11 (Aug. 23, 2017). However, this report appears isolated and,

in some places, Mr. Bynum denied dry mouth. Exhibit 11 at 5 (Sept. 20, 2017);

Exhibit 14 at 10 (Oct. 20, 2017), 6 (Nov. 20, 2017).

14

“Convincingly” is used to connote the disparity in the quality of opinions from Dr.

Younger and Dr. Mecoli. In short, Dr. Younger’s opinion regarding diagnosis was poor and Dr.

Mecoli’s opinion regarding diagnosis was strong.

20

3. Disposition

The evidence regarding diagnosis falls far short of showing that Mr. Bynum

suffered from a disease that has, according to his retained expert, eluded detection

by multiple doctors who have treated him for multiple years. There is not

preponderant support for finding that he suffered from Sjögren’s syndrome at any

time. Mr. Bynum is not entitled to compensation on any theory that the

pneumococcal vaccine caused him to develop Sjögren’s syndrome or caused any

pre-existing Sjögren’s syndrome to worsen.

A finding that Mr. Bynum did not have Sjögren’s syndrome renders the

question of whether the pneumococcal vaccine caused him to suffer Sjögren’s

syndrome hypothetical. There is no reason to explore the more complicated topic

of whether a pneumococcal vaccine can engender the production of B cells that

would lead to Sjögren’s syndrome.

B. Vasculitic Peripheral Neuropathy / Lumbrosacral Radiculoplexus

Neuropathy

1. Development of Opinions and Arguments regarding a

Neurologic Problem Possibly Affecting Mr. Bynum

The parties’ and their experts’ development of whether Mr. Bynum suffered

from vasculitic neuropathy and/or lumbosacral radiculoplexus neuropathy was

generally poor. This weakness in presentation hinders Mr. Bynum’s case because

he bears the burden of proof.

The trouble started with Dr. Younger’s first report. Although the November

22, 2019 Instructions directed experts to provided diagnostic criteria, Dr. Younger

stated that “Mr. Bynum developed autoimmune lumbrosacral radiculoplexus due to

microscopic vasculitis as a response to PCV13 vaccination,” Exhibit 30 at 4,

without identifying any diagnostic criteria. Dr. Younger, thus, was instructed to

supplement his report. Order, issued Nov. 4, 2020. Dr. Younger supplemented his

opinion by citing an article by Dyck, which was filed as Exhibit 48.15 The Dyck

article, as discussed below, is unquestionably about lumbosacral radiculoplexus

neuropathy. Thus, this reference relates to Dr. Younger’s assertion that “the

manifestation and clinical history of Mr. Bynum’s severe radiculoneuropathy, its

axonal features, clinical confirmation of peripheral neuropathy, the pre-exisiting

15

P.J. Dyck et al., “Non-diabetic lumbosacral radiculoplexus neuropathy: natural history,

outcome and comparison with diabetic variety,” 124 Brain 1197 (2001), filed as Exhibit 48.

21

forme fruste of Sjögren’s Syndrome are consistent with MV [microvasculitis] and

associated LRPN.” Exhibit 39 at 5. These reports disclosed that Dr. Younger’s

opinion was that Mr. Bynum suffered from lumbosacral radiculoplexus

neuropathy.

Dr. Callaghan, in turn, challenged the assertion that lumbosacral

radiculoplexus neuropathy was affecting Mr. Bynum. Relying upon the same

Dyck article, Dr. Callaghan stated that lumbosacral radiculoplexus neuropathy “is

characterized by severe pain followed by weakness that starts unilaterally in one

leg.” Exhibit A at 5. In Dr. Callaghan’s opinion, Mr. Bynum did not display this

symptom. Id. at 5-6. Dr. Callaghan did not opine as to whether Mr. Bynum

suffered vasculitic neuropathy.

In response, Dr. Younger did not clarify his opinion. He stated that due to

the presence of a “more severe and additional symptomology,” “the neurologic

aspects of Mr. Bynum’s condition cannot be reduced to a single neurologic

condition.” Exhibit 51 at 1. Nevertheless, and without referring to the Dyck

article, Dr. Younger seemed to maintain his opinion that Mr. Bynum suffered from

lumbosacral radiculoplexus neuropathy. Id. at 1-2.

Dr. Callaghan largely restates his prior opinions. See Exhibit E at 1. This

report completed the disclosure of opinions from people retained for this litigation.

As part of the briefing process, Mr. Bynum amended his petition. Although

it had appeared that Dr. Younger was advancing lumbosacral radiculoplexus

neuropathy, Mr. Bynum alleged that the “Prevnar vaccine . . . caused him to

develop vasculitis and vasculitic peripheral neuropathy.” Am. Pet. ¶ 14. The

amended petition does not use the term “lumbosacral radiculoplexus neuropathy.”

Mr. Bynum’s initial brief focused on vasculitis peripheral neuropathy. Pet’r’s Br.

at 4-7, 22, and 28. This focus, however, did not prevent Mr. Bynum from at least

mentioning “lumbosacral radiculoplexus neuropathy.” Id. at 6.

The Secretary at least attempted to address both vasculitic peripheral

neuropathy and lumbosacral radiculoplexus neuropathy. In the Secretary’s view,

Mr. Bynum did not establish that he suffered from either condition. Resp’t’s Br. at

42-47.

Mr. Bynum’s final word was more attentive to the question of whether he

suffered from Sjögren’s syndrome. There is, however, some mention of whether

vasculitic peripheral neuropathy and lumbosacral radiculoplexus neuropathy could

be diagnoses for Mr. Bynum. See Pet’r’s Reply at 18-19. This relatively short

22

discussion did not explicitly cite either the Hadden diagnostic criteria for vasculitic

peripheral neuropathy or the Dyck diagnostic criteria for lumbosacral

radiculoplexus neuropathy.

Based upon this record of evidence and argument, the undersigned must

“first determine which injury was best supported by the evidence in the record

before applying the Althen test.” Broekelschen v. Sec’y of Health and Human

Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010). To do so, the evidence is organized

as to whether it came from a doctor who treated Mr. Bynum or came as an opinion

from a person retained in the context of the litigation.

2. Treatment Reports

A treating doctor has not diagnosed Mr. Bynum as suffering from “vasculitic

peripheral neuropathy” or “lumbosacral radiculoplexus neuropathy.” This lack of

diagnosis is evident from a close review of Dr. Barrio, the neurologist who would

most naturally diagnose a neurologic problem, and Dr. Reams, the general

physician who most frequently saw and examined Mr. Bynum until before and

after the vaccination. Each saw Mr. Bynum in 2015 and later in 2017. The

following is a discussion of the records generated in 2015 and 2017.

a) Records Created in 2015

Mr. Bynum received the pneumococcal vaccine on June 26, 2015. Exhibit

1 at 3. Thus, the focus of analysis is on medical records created within a few

months of the vaccination.

In Mr. Bynum’s presentation to Dr. Brian Shaheen on June 30, 2015, he

complained about dizziness, unstability, and headaches. Exhibit 5 at 58. Dr.

Shaheen did not diagnose Mr. Bynum as suffering from “vasculitic peripheral

neuropathy” or “lumbosacral radiculoplexus neuropathy.” Id. Dr. Younger did not

cite this report as suggesting that Mr. Bynum suffered from either of these

conditions. See Exhibit 39 at 5.

A more critical report was Dr. Barrio’s August 31, 2015 report. Mr. Bynum

has cited this report as evidencing his claim that he suffered from vasculitic

peripheral neuropathy or lumbosacral radiculoplexus neuropathy. See Pet’r’s Br.

at 6. On that day, Mr. Bynum told Dr. Barrio that after the Prevnar vaccination,

“he started developing significant issues with dizziness, headache, slight altered

mental status, dysphagia, tremor with difficulty with coordination that have all

been slightly progressive.” Exhibit 7 at 23. For these problems, Dr. Barrio

“recommended an MRI of his brain to rule out any other postviral

23

encephalomyelitis versus autoimmune encephalitis cause.” Id. at 25. Mr. Bynum

draws attention to Dr. Barrio’s suggestion that Mr. Bynum might have an

“autoimmune” problem. Pet’r’s Br. at 6. However, Mr. Bynum overlooks the

context that Dr. Barrio was concerned in the context of a disorder of the central

nervous system, which is why Dr. Barrio ordered an MRI of the brain. Exhibit 7 at

23.

When Dr. Barrio reviewed Mr. Bynum’s neurologic system, Dr. Barrio

recorded that Mr. Bynum reported “numbness, tingling, lightheadedness, vertigo,

morning headaches, focal weakness and unsteady gait.” Id. at 24. Mr. Bynum also

cites these symptoms. Pet’r’s Br. at 24. However, Mr. Bynum does not cross-

reference either the Hadden diagnostic criteria for vasculitic peripheral neuropathy

or the Dyck diagnostic for lumbosacral radiculoplexus neuropathy. In any event,

Dr. Barrio’s plan to address these symptoms was to order an EMG / NCS. Exhibit

7 at 26.

The October 15, 2015 lower extremity EMG / NCS could have been

discussed in more detail. Dr. Barrio included the results of specific tests. Exhibit

7 at 11-14. His bottom-line impression was that the “electrodiagnostic study also

reveals evidence of moderate chronic multilevel lumbosacral radiculopathy on the

right and left.” Id. at 10.

In the follow-up appointment on October 23, 2015, Dr. Barrio did not

diagnose Mr. Bynum with vasculitic peripheral neuropathy or lumbosacral

radiculoplexus neuropathy. See Exhibit 7 at 5 (Oct. 23, 2015). Dr. Barrio also did

not order any treatment for these conditions. Id.

The parties do not discuss any diagnoses made (or not made) by Dr. Barrio

in 2015. Mr. Bynum refers to a November 9, 2015 report from Dr. Reams. Pet’r’s

Br. at 5. Then, Mr. Bynum informed Dr. Reams that he was having pain in his legs

bilaterally. He stated the pain is “burning” and is associated with “limping, . . .

tingling in the legs and confusion.” Exhibit 5 at 86. Dr. Reams ordered an MRI of

Mr. Bynum’s lumbar spine. Id. at 88. Dr. Reams did not diagnose Mr. Bynum as

suffering from vasculitic peripheral neuropathy or lumbosacral radiculoplexus

neuropathy.16

16

In early 2016, a home health aide memorialized that Mr. Bynum was having difficulty

walking. Exhibit 12 at 5; see also Pet’r’s Br. at 5. However, difficulty in walking is not

diagnostic for either vasculitic peripheral neuropathy or lumbosacral radiculoplexus neuropathy.

24

b) Records Created in 2017

Medical records that Dr. Barrio created in 2017 are featured more

prominently in Mr. Bynum’s argument that he suffered from vasculitic peripheral

neuropathy or lumbosacral radiculoplexus neuropathy. See Pet’r’s Br. at 4; see

also Pet’r’s Reply at 18. In Mr. Byum’s view, Dr. Barrio diagnosed him with

“peripheral neuropathy” and “vasculitis.” But, Mr. Bynum appears to be taking

these comments out of context.

Mr. Bynum renewed treatment with Dr. Barrio on August 23, 2017. Exhibit

11 at 10. Dr. Barrio wrote that Mr. Bynum said his symptoms, such as tremor,

memory loss, gait instability, have progressed over the past two years. Id. In this

context, Dr. Barrio’s impression included eight items, of which two were

“vasculitis” and “neuropathy.” Id. at 12. Dr. Barrio, again, ordered studies of Mr.

Bynum’s brain. After these studies were done, Dr. Barrio ordered another EMG /

NCS. Id. at 6 (Sep. 20, 2017).

The EMG / NCS took place on October 3, 2017. Exhibit 14 at 15. This

combined study “did show a severe length-dependent peripheral neuropathy that

appears to have more axonal greater than demyelinating features.” Id. The follow

up was with Mr. Johnson and then with Dr. Barrio. Neither diagnosed Mr. Bynum

with “vasculitic peripheral neuropathy” or “lumbosacral radiculoplexus

neuropathy.” See Exhibit 14, passim.

Years later, in a letter for Mr. Ragsdale, Dr. Reams supported “Dr.

Younger’s opinion of autoimmune vasculopathy.” Exhibit 75 at 2. But, the same

flaws reduce the persuasive value of this opinion. Dr. Reams is not a neurologist;

he did not review the opinion from the expert the Secretary retained, and he did not

explain why he did not diagnose Mr. Bynum with an “autoimmune vasculopathy”

during his treatment.

In short, taken individually or collectively, the reports created during

treatment do not support a finding that Mr. Bynum suffered from either vasculitic

peripheral neuropathy or lumbosacral radiculoplexus neuropathy.

3. Opinions from People Retained in the Litigation

Mr. Bynum argues that Dr. Younger’s opinion supports his claim regarding

vasculitic peripheral neuropathy. Pet’r’s Br. at 4. However, Dr. Younger’s

opinion is not persuasive.

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As discussed above, it is not entirely clear that Dr. Younger opined that Mr.

Bynum suffered from vasculitic peripheral neuropathy. The thrust of Dr.

Younger’s reports was that Mr. Bynum suffered from lumbosacral radiculoplexus

neuropathy. See Exhibit 30, Exhibit 39. Dr. Younger, for example, did not cite the

Hadden article for the diagnostic criteria of vasculitic peripheral neuropathy.

To the extent that Mr. Bynum is attempting to springboard the Hadden

diagnostic criteria as a basis for finding that Mr. Bynum suffered from vasculitic

peripheral neuropathy, that leap is too far for Mr. Ragsdale to make. See Pet’r’s

Br. at 4-5. One factor potentially contributing to a “suggestive” diagnosis of

vasculitic neuropathy is “electrodiagnostic evidence of an axonal neuropathy

(symmetric or asymmetric).” Exhibit 31 (Hadden) at 1572 (table 4, item I.a.). It

might have been helpful for Dr. Younger to address whether the October 15, 2015

lower extremity EMG / NCS supported his opinion. Without an expert’s

interpretation of the EMG / NCS, the undersigned is reluctant to find that the EMG

/ NCS conducted approximately four months after vaccination supports a diagnosis

of vasculitic peripheral neuropathy.

Dr. Callaghan directly states that the October 15, 2015 EMG / NCS “did not

reveal[] a lumbosacral radiculoplexus neuropathy nor the characteristic asymmetry

that would be seen in this condition.” Exhibit A at 6. Saying the EMG / NCS is

not consistent with “a lumbosacral radiculoplexus neuropathy” is not exactly the

same as saying the EMG / NCS is inconsistent with a vasculitic peripheral

neuropathy.17 In any event, Dr. Younger did not contest how Dr. Callaghan

interpreted the October 15, 2015 EMG / NCS. For example, Dr. Younger did not

say that the October 15, 2015 EMG / NCS supported a diagnosis of either

vasculitic peripheral neuropathy or lumbosacral radiculoplexus neuropathy. See

Exhibit 51.

Instead, Dr. Younger maintained that Mr. Bynum’s reports of weakness

satisfied the diagnostic criteria for lumbosacral radiculoplexus neuropathy set forth

in Dyck. Id. at 1. But, Dr. Younger has missed the point. Dr. Callaghan had

opined that lumbosacral radiculoplexus neuropathy includes “weakness that starts

unilaterally in one leg.” Exhibit A at 5. The Dyck article supports this definition

17

To some degree, Dr. Callaghan’s evaluation of whether Mr. Bynum suffered from

lumbosacral radiculoplexus neuropathy is understandable. The report to which Dr. Callaghan is

responding did not claim that Mr. Bynum suffered from vasculitic peripheral neuropathy.

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as all 57 patients had “asymmetric lower limb pain.” Exhibit 48 at 1199. Mr.

Bynum’s leg pain and weakness was bilateral. Exhibit 5 at 86 (Nov. 9, 2015).

Furthermore, at least to a degree, Dr. Younger’s opinion that Mr. Bynum

suffered from some type of peripheral neurologic disorder depends upon Mr.

Bynum suffering from Sjögren’s syndrome. See Pet’r’s Reply at 8-9; Exhibit 39 at

5 (Dr. Younger: “In my opinion, Mr. Bynum’s neurologic manifestations are

probably a result of vaccination related autoimmune vasculopathy overlapping, or

in association with, contemporaneous SS.”). For the reasons explained in section

VI.A., this predicate assumption is not justified with preponderant evidence.

4. Disposition

When considered as a whole, the record does not support a finding that Mr.

Bynum suffered from either vasculitic peripheral neuropathy or lumbosacral

radiculoplexus neuropathy. The doctors who treated Mr. Bynum across several

years did not use those terms and did not prescribe any treatments for those

conditions. Moreover, the reports from Dr. Younger were confusing and lacked a

persuasive explanation for how Mr. Bynum met a relevant set of diagnostic

criteria. Accordingly, there is no need to consider whether the pneumococcal

vaccine can cause either vasculitic peripheral neuropathy or lumbosacral

radiculoplexus neuropathy.

VII. Conclusion

Long before Mr. Bynum initiated this litigation, he stated that the

pneumococcal vaccine might have caused his problems. Thus, Mr. Bynum’s good

faith belief about suffering an injury due to the vaccination is not questioned. But,

Mr. Bynum must rest his case on more than just his belief. The evidence shows

that Mr. Bynum did not establish that he suffered from any of the conditions that

he associates with the vaccination. Therefore, he cannot receive compensation.

The Clerk’s Office is instructed to enter judgment in accord with this

decision unless a motion for review is filed. Information about filing a motion for

review, including the deadline, can be found in the Vaccine Rules, which are

available on the website for the Court of Federal Claims.

IT IS SO ORDERED.

s/Christian J. Moran

Christian J. Moran

Special Master

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