Velasquez v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 19-1703V

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FIDENCIO VELASQUEZ, *

* Chief Special Master Corcoran

*

Petitioner, * Filed: January 31, 2024

*

v. *

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

*

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Scot Tyler Scheuerman, Scheuerman Law Firm PLLC, San Antonio, TX, for Petitioner.

Zoe Wade, U.S. Department of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION 1

On November 1, 2019, Fidencio Velasquez filed this action seeking compensation under

the National Vaccine Injury Compensation Program (the “Program”). 2 ECF No. 1. Petitioner

alleges that an influenza (“flu”) vaccine he received on November 1, 2016, caused him to incur

Guillain-Barré syndrome (“GBS”). Id. Although the matter was originally assigned to the “Special

Processing Unit” (“SPU”), since it appeared to assert the kind of claim often easily settled, fact

issues pertaining to the nature of injury as well as its timing resulted in the claim’s transfer to my

regular docket.

1

As provided by 42 U.S.C. § 300aa-12(d)(4)(B), the parties may object to the published Decision’s inclusion of certain

kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen (14) days within

which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or

financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure

of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the entire

Decision will be available to the public in its current form. Id.

2

The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,

100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the

Act”]. Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

The parties have submitted expert reports and offered briefs so that the matter can be

resolved via ruling on the record. See Petitioner’s Motion, dated June 12, 2023 (ECF No. 54)

(“Mot.”); Respondent’s Opposition, dated September 18, 2023 (ECF No. 61) (“Opp.”). For the

reasons stated in more detail below, I deny compensation.

I. Fact History

Mr. Velasquez was fifty-two years old at the time of vaccination, and was then employed

by a golf course in Eagle Pass, TX. Ex. 2 at 14; Ex. 7 at 1, ⁋4. His medical history was significant

for diabetes and hypertension, and he received a number of medications in treatment of these pre-

vaccination conditions. Certified Medical Records - Hector Trevino, MD, filed on June 12, 2020

(ECF No. 21-3) at 16–78 (handwritten records from 2011-16 noting diabetes, hypertension, and

cholesterol medications).

Even more importantly, the record establishes that Petitioner sought treatment in the days

immediately prior to vaccination for a gastrointestinal complaint. Specifically, on Friday, October

28, 2016 (four days before receiving the flu vaccine at issue), he saw his primary care physician

(“PCP”), Hector Trevino, M.D., reporting abdominal pain and fatigue starting the day prior, as

well as two days of diarrhea and fever. Ex. 2 at 19. He was diagnosed with “[g]astroenteritis” and

prescribed an antibiotic. Id. Around this time he also underwent blood testing in connection with

his previously-diagnosed diabetes. Ex. 2 at 18.

Vaccination and Neurologic Symptoms Onset

Petitioner received the flu vaccine at issue in this case on Tuesday, November 1, 2016, in

connection with a follow-up visit to Dr. Trevino to discuss the results of his lab workup for his

diabetes (which was noted to be poorly controlled). Ex. 2 at 14, 16. (Indeed—the results of the

testing lead to a treater determination to increase Petitioner’s insulin dose (Id. at 16)). Petitioner at

this time express a new complaint of back pain, and Dr. Trevino’s exam noted back pain and right

leg weakness, but without pain on palpation. Id. at 16.

Three days later (November 4th), Petitioner went to Fort Duncan Medical Center

Emergency Department (“ED”), reporting that he “has been not feeling well for approximately one

week.” Ex. 3 at 9. (If correct, this would place onset prior to vaccination). The history taken at this

time memorializes Mr. Velasquez’s statement that he was experiencing headaches and

paresthesias, plus lower extremity weakness, and that he believed his prior vaccination could be

the cause. Id. at 9, 88. The ER exam was normal, however, and also normal from a neurologic

perspective, and other testing (X-ray, CT scan, and lab work) yielded normal results as well. Id. at

10–12. Mr. Velasquez was discharged that same day from the ED in stable condition and advised

to follow up with his PCP. Id. at 12–13.

2

Then, on the evening of November 6, 2016 (now five days post-vaccination), Mr.

Velasquez was admitted to the ED at Baptist Medical Center based on his reports of “[p]rogressive

weakness since flu vaccine, reporting generalized weakness, unable to open right hand well.” Ex.

4 at 52. Petitioner claimed an onset of hand-related weakness to have occurred immediately before

arrival at the hospital, but that otherwise he had been experiencing constant, worsening symptoms

impacting his ability to walk (due to weakness in his legs) for five days, or since the date of

vaccination. Id. Testing performed at this time revealed high blood pressure and blood sugar levels,

although otherwise the exams again produced normal findings. Id. at 53, 55. Petitioner was held

overnight but then discharged—and he was now proposed to have a peripheral neuropathy given

his reported history of leg weakness. Id. at 67–74.

Follow-Up Treatment After Fall 2016 Onset

After this second ED encounter from early November 2016, Petitioner saw Dr. Trevino

again. Ex. 2 at 13. Petitioner now provided a more precise date for onset of his symptoms,

informing Dr. Trevino that he had started to feel right hand weakness on November 3rd—two days

after going bowling (and getting vaccinated the same day). Id. The physical medical record from

this visit includes a handwritten timeline of these events. Id.

On exam, Petitioner displayed left and right hand weakness, and he could not extend the

fingers on his left hand. Ex. 2 at 13. He also was experiencing arm and leg weakness, but reported

improvement in his leg strength. Id. Dr. Trevino assessed Mr. Velasquez at this time with GBS,

“most likely improving.” Id. This is the first record in which GBS was proposed as a diagnostic

explanation for Petitioner’s medical complaints.

Petitioner saw Dr. Trevino another time on November 10, 2016, for follow-up treatment

for his limb weakness. Ex. 2 at 12. He was noted to be displaying strength improvement, and was

now able to tiptoe, but still unable to heel walk. Id. Dr. Trevino again opined that GBS was the

“most likely” diagnosis, and noted “consider adverse [reaction] to flu shot.” Id. Petitioner was

referred to neurology, and informed he would likely need to limit work for several months. Id.

Days after this visit, Dr. Trevino’s office reached out to the vaccine manufacturer to report

Petitioner’s purported vaccine reaction. Ex. 2 at 11.

Petitioner thereafter had his first neurologic evaluation in mid-November 2016, with Dr.

Fernando Sanchez, at the Fernando Sanchez Clinical Neurophysiology Center. Ex. 5 at 17–18.

Petitioner’s reported onset was now three days post-vaccination (or November 4th), and he

described the weakness that he had previously reported in connection with his ED visits. Id. at 17.

On exam, petitioner’s reflexes were normal, and displayed moderate quadriceps strength, but had

bilateral wrist and foot drop. Id. Based solely on this exam and a normal MRI result, Dr. Sanchez

3

diagnosed petitioner with “GBS, postvaccinal, motor axonal variant,” and noted the need to

perform an EMG. 3 Id. at 17, 18.

The planned EMG of the left upper and lower extremities occurred on December 2, 2016.

Ex. 5 at 16, 40–44. Its results were interpreted to reveal the presence of an “[a]cute, predominantly

axonal motor polyneuropathy,” with “motor axonal loss and active denervation in distal [more

than] proximal limb muscles.” Id. A few days later, Petitioner saw Dr. Trevino again, who

observed some improvements but assessed Mr. Velasquez with “GBS post[-]vaccinal motor

axonal variant,” which he expected to improve in three to six weeks. Ex. 2 at 10. Some additional

progress was also noted later that month in a subsequent visit to Dr. Trevino, although it was

expected that monitoring would be necessary to evaluate when Petitioner’s strength had

sufficiently returned to permit him to work again. Id. at 9.

2017 Treatment and Subsequent Medical History

On January 16, 2017, Petitioner saw Dr. Trevino, reporting ongoing issues with the use of

his hands and legs. Ex. 2 at 8. His diabetes also remained poorly controlled. Id. Dr. Trevino

supplied him with work absence authorizations given his continued weakness. Id. at 7. That same

month, Petitioner also went back to Dr. Sanchez for further neurologic treatment. Ex. 5 at 15. He

displayed mild improvement but continued to experience hand grip and leg weakness. Id. Dr.

Sanchez projected sequelae from GBS to persist for several additional months, but also proposed

that Petitioner could soon return to work (albeit with some activity restrictions). Id. Petitioner

attempted to do so at the end of January, but found his ongoing weakness impeded his ability to

perform tasks at work. Ex. 2 at 5.

For the remainder of 2017, Petitioner reported lingering hand grip issues and limb

weakness, albeit with some moderate improvement as time passed. See, e.g., Ex. 2 at 4 (July 2017

visit with Dr. Trevino); Ex. 5 at 31 (August 2017 visit to new neurologist); Ex. 2 at 2 (October

2017 visit to Dr. Trevino); Ex. 5 at 13 (November 2017 follow-up visit to Dr. Sanchez). The same

general symptoms were also reported the following year. Ex. 5 at 12 (June 2018 visit to Dr.

Sanchez, reporting pain, bilateral limb weakness in the upper and lower extremities).

In later 2018 into 2019, Petitioner experienced decreased muscle strength and right-sided

weakness. Ex. 5 at 11 (December 2018 visit to Dr. Sanchez reporting hand tremor and bilateral

weakness more notable on the right side of the body); Ex. 5 at 10 (June 2019 visit to Dr. Sanchez

reporting right-sided fatigue and weakness). Petitioner stopped treatment for his issues after June

3

An “EMG,” or electromyogram, is the record from an electromyography, “an electrodiagnostic technique for

recording the extracellular activity of skeletal muscles at rest, during voluntary contractions, and during electrical

stimulation.” Electromyogram, Dorland’s Medical Dictionary Online

(https://www.dorlandsonline.com/dorland/definition?id=15852) and Electromyography, Dorland’s Medical

Dictionary Online (https://www.dorlandsonline.com/dorland/definition?id=15854&searchterm=electromyography)

4

2019, but states in his affidavit that he still feels weakness on a daily basis. Ex. 7 at 2. Petitioner

was able to resume part-time work in September 2019, and then full-time work in January 2020.

Id.

II. Expert Reports/Treater Statements

A. Petitioner’s Expert – David M. Simpson, M.D.

Dr. Simpson, a neurologist, prepared two written reports for the Petitioner. Report, dated

April 5, 2022, filed as Ex. 15 (ECF No. 43-2) (“First Simpson Rep.”); Report, dated June 3, 2023,

filed as Ex. 18 (ECF No. 53-3) (“Second Simpson Rep.”).

Dr. Simpson is a Professor of Neurology and the Director of the Neuromuscular Division

and Clinical Neurophysiology Laboratories at the Icahn School of Medicine at Mount Sinai, where

he has worked as an Attending Neurologist since 1984. Curriculum Vitae of David Simpson, MD,

FAAN, filed on April 5, 2022 (ECF No. 43-3) (“Simpson CV”). He received his medical degree

from SUNY at Buffalo School of Medicine, and underwent residency and fellowship training at

Cornell University Medical Center and Massachusetts General Hospital. Simpson CV at 1. He is

certified by the National Board of Medical Examiners, the American Board of Psychiatry and

Neurology with subspecialties in Clinical Neurophysiology and Neuromuscular Medicine, and the

American Board of Neuromuscular and Electrodiagnostic Medicine. Id. He has been published

extensively on the subject of central and peripheral neurological disorders. Id. at 22–36.

First Report

Dr. Simpson’s initial report responded to the opinion submitted by Respondent’s expert,

Dr. Mark Bromberg. He began by detailing the materials he reviewed, then provided his own

summary of Petitioner’s relevant medical history. See First Simpson Rep. at 2–4. He then noted

the medical and scientific support for an association between the flu vaccine and two subvariants

of GBS—acute inflammatory demyelinating polyneuropathy (“AIDP”) or chronic inflammatory

demyelinating polyneuropathy (“CIDP”). Id. at 4–5. Because this Decision does not turn on the

nature of the injury, this part of Dr. Simpson’s report does not merit much discussion. However,

in this section, Dr. Simpson did note that “numerous biologic mechanisms” had been proposed for

how a vaccine could result in GBS, including an autoimmune cross-reaction due to molecular

mimicry—a process that would inherently implicate the secondary, adaptive immune response. Id.

at 4, 5.

Mr. Velasquez’s GBS, Dr. Simpson maintained, was more likely that not caused by his

preceding vaccination. First Simpson Rep. at 9. To support this opinion, Dr. Simpson analyzed

both the post-vaccination timeframe for onset plus some of the points made about Petitioner’s

history by his treaters, Drs. Trevino and Sanchez. He deemed onset to have occurred three days

5

after vaccination, relying on Petitioner’s affidavit (even though contemporaneous records

suggested an earlier onset—or even one predating vaccination). Id. at 5. Such an onset was

consistent with not only existing science, but the Table as well. Id. at 5–6. In fact, he maintained,

the “true range of attributable risk” was greater, on both ends, than the Table’s 3-42 day period.

Id. at 5, 6–7; Y. Park et al., Clinical Features of Postvaccination Guillain-Barré Syndrome (GBS)

in Korea, 32 J. Korean Med. Sci. 1154, 1156 (2017) (“Park”) 4; L.B. Schonberger et al., Guillain-

Barre Syndrome Following Vaccination in the National Influenza Immunization Program, United

States, 1976-1977, 110 Am. J. Epidemiol. 105, 123 (1979) (“Schonberger”).

Dr. Simpson then turned to evidence from Petitioner’s history he deemed supportive of his

opinion. He noted “severe generalized weakness” observed by Petitioner’s treaters as a primary

criterion of GBS. First Simpson Rep. at 8. In addition, the EMG testing performed on Petitioner

in 2016 revealed “motor axonal neuropathy,” consistent with a GBS variant other than AIDP or

CIDP—acute motor axonal neuropathy, or “AMAN.” Id. He deemed the AMAN variant also

associated with the flu vaccine, citing literature for this contention. A. Shaikh et al., Atypical Forms

of Guillain-Barré Syndrome and H1N1-influenza Vaccination, 30 Vaccine 3251, 3254 (2012). And

a second EMG (albeit one performed in late summer 2018—almost two years after the vaccination

event) was consistent with “poorly recovered GBS or CIDP,” since there was evidence of axonal

degeneration. First Simpson Rep. at 8.

The possibility that Petitioner’s GBS was associated with his pre-vaccination

gastroenteritis infection was dismissed by Dr. Simpson. He acknowledged that the record clearly

established Petitioner had received treatment for gastrointestinal symptoms, and that they could

have been caused by a Campylobacter jejuni bacterial infection. First Simpson Rep. at 8. But he

purported that reliable medical literature suggested onset of GBS associated with such a specific

bacterial infection occurred no sooner than a week after vaccination—meaning that Petitioner’s

onset was “too early” to have had this as its cause. Id; B. Allos, Association Between

Campylobacter Infection and Guillain-Barre´ Syndrome, 176 J. Infect. Dis. 125 (1997).

In addition (and as noted below), Dr. Trevino had proposed that, in light of Petitioner’s

subsequent medical history, these gastrointestinal symptoms might be better now understood to

have been reflective of gall bladder disease. First Simpson Rep. at 8. And it was not clear at all

whether Petitioner’s symptoms were otherwise caused by a viral infection, or even some other

kind of bacterial infection not associated with GBS (unlike C. jejuni). Id. at 8–9. Petitioner had

never been tested to see if he possessed a C. jejuni infection, and it was now far too late to do so.

And no other possible explanatory cause existed for why Petitioner had developed any form of

GBS. Id. at 9.

4

Petitioner never filed any of the medical literature referenced in Dr. Simpson’s report. Accordingly, there are no

record citations to them, and their contents could not be reviewed (although I am familiar with some of the items

referenced, based on my experience adjudicating comparable claims).

6

Second Report

Dr Simpson prepared a brief supplemental report addressing some of Dr. Bromberg’s

criticisms of his initial opinion. He noted that there was no disagreement as to the fact that

Petitioner had experienced some form of peripheral neuropathy; the primary dispute between the

neurologic non-treating experts was what the electrodiagnostic testing results revealed about the

specific character of the neuropathy. Second Simpson Rep. at 1–2. Based on his own review of the

results, Dr. Simpson deemed Dr. Bromberg’s criticisms about inaccuracies in the EMG study not

well-founded, relying as well on his interpretive views that certain findings were atypical for GBS.

Id. In the end, Dr. Simpson deemed the results to be fully consistent with the AMAN form of

GBS—observing that not only had Dr. Sanchez so concluded, but also that Dr. Bromberg himself

had allowed this to be likely. Id. at 2.

Next, Dr. Simpson addressed Dr. Bromberg’s contentions regarding alternative causes for

Mr. Velasquez’s GBS. First, he denied that Petitioner’s presentation was reflective of a diabetic

neuropathy, arguing that Petitioner had no neurologic symptoms before vaccination, and otherwise

that his clinical features and EMG/NSC testing were “entirely consistent with GBS” as opposed

to a different form of neuropathy. Second Simpson Rep. at 2. Second, he reiterated prior points

about why Petitioner’s GBS was unlikely the product of a C. jejuni infection, since the onset in

this case was too long, and given his speculation that Petitioner’s 2016 symptoms were more likely

reflective of gall bladder disease. Id. at 3. Dr. Simpson concluded with another overview of

molecular mimicry as a likely, vaccine-induced mechanism for GBS. He emphasized the fact that

there existed substantial support in the medical and scientific literature for a vaccine association.

Id.

C. Treating Expert Opinions

1. Dr. Hector Trevino – As the medical record discussed above demonstrates,

Dr. Trevino was Petitioner’s PCP, treating him contemporaneously with both his vaccination,

intercurrent gastrointestinal illness, and then when neurologic symptoms first manifested. He has

offered a brief affidavit addressing certain fact issues in this case. See Affidavit, dated June 23,

2021, filed as Ex. 12 (ECF No. 32-2) (“Trevino Aff.”).

Dr. Trevino’s affidavit begins with a reiteration of the treatment for perceived

gastroenteritis that he provided Petitioner immediately before the November 1, 2016 vaccination.

Trevino Aff. at 1. He proposed that because Petitioner was prescribed a seven-day course of

antibiotics, he should have been clear of the bacteria at the end of the course. Id. But because the

records revealed Petitioner was still receiving the medication as of November 6th, it was likely the

bacteria responsible (which he acknowledged was often C. jejuni in cases of gastroenteritis)

remained present. (He later noted that it could not be ascertained from the record with certainty

whether Petitioner’s gastroenteritis was viral or bacterial in origin. Id. at 2).

7

However, Dr. Trevino added, medical literature suggested that GBS attributable to C. jejuni

typically had a somewhat-longer timeframe onset of one to three weeks. Trevino Aff. at 2; Irving

Nachamkin et al., Campylobacter Species and Guillain-Barré Syndrome, 11 Clin. Microbiol. Rev.

555, 556 (1998). 5 Thus, if Petitioner’s GBS were due to a C. jejuni wild infection, it should not

have manifested until November 11th at the earliest. Trevino Aff. at 2. This left, in Dr. Trevino’s

opinion, the vaccine as the only likely cause. Id. He also added that although Petitioner had

complained of back problems on November 1st, he had not deemed them at any later time to be

associated with GBS. Id.

Besides these opinions, Dr. Trevino also offered a statement about the import of certain

treatment findings made in the spring of 2021 (and hence nearly four and a half years post-

vaccination). Trevino Aff. at 2, 3-6; see also Ex. 14 at 6-30. He noted that the operative report

associated with the cholecystectomy (gallbladder removal) procedure performed on Petitioner in

March 2021 supported the conclusion that Petitioner had actually been suffering from gallbladder

disease—the symptoms of which he purported “overlap” with those of gastroenteritis. Trevino Aff.

at 2. Thus, the very diagnosis of gastroenteritis was called into question, as the symptoms Petitioner

displayed in October 2016 could have reflected “a flair up of his chronic gallbladder disease.” Id.

2. Dr. Fernando Sanchez – Dr. Sanchez, Petitioner’s neurologist from

November 2016 to June 2019, prepared a brief affidavit in support of the claim. See Affidavit,

dated June 25, 2021, filed as Ex. 13 (ECF No. 32-3) (“Sanchez Aff.”). He indicates therein that

the records of Petitioner’s treatment with Dr. Trevino revealed a pre-vaccination diagnosis of a

bacterial gastroenteritis (a conclusion he reached based on the medicine then prescribed), and that

onset seemed to have begun November 3, 2016 (hence two days after Petitioner received the flu

vaccine). Sanchez Aff. at 1.

Dr. Sanchez then opined that the flu vaccine had caused Petitioner’s GBS. Sanchez Aff. at

1. In so opining, he acknowledged that C. jejuni is “[t]he most common cause” for the kind of

gastroenteritis Petitioner experienced, and that the same infection is associated with GBS. Id.

Nevertheless, onset for a bacterially-caused GBS would occur no sooner than seven to ten days

post-infection—whereas in this case Petitioner’s GBS began far sooner. Id. at 2. Because of this,

and because there were no other explanations evident from the record that could account for

Petitioner’s injury, the vaccine was left as most likely causal. Id.

5

Petitioner has not filed any of the medical literature referenced by Dr. Trevino. Accordingly, there are no record

citations.

8

C. Respondent’s Expert – Mark B. Bromberg, M.D.

Dr. Bromberg prepared three expert reports in this case. Report, dated November 29, 2021,

filed as Ex. A (ECF No. 39-1) (“First Bromberg Rep.”); Report, dated October 12, 2022, filed as

Ex. K (ECF No. 50-1) (“Second Bromberg Rep.”); Report, dated August 8, 2023, filed as Ex. L

(ECF No. 59-1) (“Third Bromberg Rep.”).

Dr. Bromberg is an academic neurologist and professor at the University of Utah.

Curriculum Vitae of Mark B Bromberg, M.D., filed November 29, 2021 (ECF No. 39-2)

(“Bromberg CV”). He received his Ph.D. in neurology from the University of Vermont, and his

medical degree from the University of Michigan. Bromberg CV at 1. In addition to being a

professor, he sees patients in a general neurology clinic. Id. at 2. He has published many neurology

articles, and authored a textbook on peripheral neuropathies and the diagnosis of small fiber

neuropathies. Id. at 19–37. He is certified by the American Board of Psychiatry and Neurology

and the American Board of Electrodiagnostic Medicine, and holds medical licenses in Utah and

Wyoming. Id. at 6.

First Report

Dr. Bromberg’s initial report reacted to the two affidavits from Petitioner’s treaters, Drs.

Trevino and Sanchez. He began by summarizing Petitioner’s medical history, emphasizing certain

aspects of it. First Bromberg Rep. at 1–6. He noted, for example, Petitioner’s pre-vaccination

history of diabetes and the associated high A1c readings. 6 Id. at 2. He highlighted the

electrodiagnostic testing performed on Petitioner in December 2016, which confirmed the

existence (in Dr. Sanchez’s view) of a “predominantly axonal motor neuropathy” (Id. at 2), but

which did not also reveal significant demyelination or sensory nerve loss. Id. at 3, 7. 7 And he

observed ongoing deficiencies into late 2017 and even 2018. Id. at 5–6.

Dr. Bromberg next provided his understanding of GBS as a clinical diagnosis. He noted

that the term includes “a spectrum of disorders,” from an acute form to the AMAN version

apparently at issue in this case. First Bromberg Rep. at 6. He found reasons to question whether

AMAN was the best diagnostic descriptor for Petitioner’s injury, however. Several indicia set forth

6

See Hennessey v. Sec'y of Health & Hum. Servs., 91 Fed. Cl. 126, 131 (2010) for explanation of the difference

between blood glucose levels and A1c: “Because hemoglobin A1c has a known finite life span, the percentage of

hemoglobin A1c at any given time can be used to determine the average level of blood glucose for a period prior to

the test. Unlike spot readings of current blood glucose levels, a hemoglobin A1c test result changes very slowly and

represents an average of blood glucose levels over the previous three to four months. Thus, this one test serves the

same function as multiple spot readings of the constantly fluctuating glucose levels.”

7

Dr. Bromberg did question the accuracy of this testing, however, noting several findings that were either consistent

with error in how the testing was performed, or reflected other potential “operator technical difficulties”—leading him

to opine that the test results had to be “force-fitted into a diagnosis of AMAN.” First Bromberg Rep. at 7.

9

in widely-accepted medical community criteria (preservation of tendon reflexes or asymmetry of

weakness) were absent, for example. Id. at 7. In addition, the lower limb areflexia common to GBS

was never observed in Mr. Velasquez’s case. Id, S. Kuwabara et al., Hyperreflexia in Guillain-

Barré Syndrome: Relation With Acute Motor Axonal Neuropathy and Anti-GM1 Antibody, 67 J.

Neurol. Neurosurg. Psychiatry 180, 181 (1999), filed as Exhibit K (ECF No. 39-5). The fact that

Petitioner displayed plantar issues, or even hyperreflexia, were also not consistent with GBS. First

Bromberg Rep. at 7. And the same was true for the predominantly upper limb/hand and wrist

weakness without reduced or absent reflexes were also not common to the AMAN GBS variant.

Id. Nevertheless, Dr. Bromberg allowed that Petitioner’s overall presentation was “possibly”

reflective of an atypical AMAN presentation. Id.

But even if GBS were a reasonable diagnosis, Dr. Bromberg denied that Petitioner’s

vaccination could explain it. Rather, it was more likely the product of the pre-vaccination

gastrointestinal infection Petitioner had experienced. Reliable literature suggested that in the

majority of cases, GBS was attributable to some form of preexisting infection. First Bromberg

Rep. at 8; Penina Haber et al., Vaccines and Guillain-Barré Syndrome, 32 Drug Safety 309, 310

(2009), filed as Exhibit G (ECF No. 39-7). Moreover, C. jejuni infections were specifically

associated with the AMAN GBS variant. Pei Shang et al., Axonal Variants of Guillain-Barré

Syndrome: An Update, 268 J. Neurol. 2402, 2403 (2021), filed as Exhibit H (ECF No. 39-8). Here,

the record established that Petitioner had experienced some kind of gastrointestinal illness prior to

neurologic symptoms onset—and hence it was likely that a C. jejuni infection had caused those

initial symptoms.

The timing of that infectious process also cast into doubt the vaccine’s causality. The

medical record clearly established that Petitioner’s gastrointestinal symptoms began several days

prior to vaccination, and Dr. Bromberg interpreted the record to pinpoint an onset for such

symptoms as October 26-27, 2016. First Bromberg Rep. at 8. The record allowed for some

possibility of GBS onset pre-vaccination, however, since Petitioner had (at the time of his initial

ED visit) suggested in his medical history that he had been experiencing comparable numbness

and weakness for a week—or before the November 1st vaccination. Id. In fact, Petitioner

complained of leg weakness at the same visit he obtained the vaccine. Id. The flu vaccine could

not be causal of Petitioner’s AMAN if it began before vaccination.

Moreover, record evidence of initial, post-vaccination symptoms revealed they had

occurred too close in time to the vaccine’s administration to suggest the timeframe was medically

acceptable. As Dr. Bromberg noted, ED medical records, plus records from Petitioner’s visits to

Dr. Trevino later, supported an onset of either immediately after vaccination, or by November 3rd

at the latest (two days post-vaccination). First Bromberg Rep. at 8. Any such timeframe would be

inconsistent with vaccine causality, since the theory by which GBS was thought to occur post-

vaccination relied on molecular mimicry between the vaccine’s presenting antigens and self

10

structures. Id; Haber at 312. But the autoimmune cross-reactive process that would cause nerve

damage would be mediated by the adaptive immune response—“and this process, if vaccine-

induced, likely takes longer than 48 hours to result in clinical symptoms.” First Bromberg Rep. at

8. A two-day onset was certainly incompatible with the flu vaccine-GBS Table claim, which

required onset to occur no sooner than three days post-vaccination. Id.

At the same time, Dr. Bromberg opined, Petitioner’s neurologic symptoms onset was

consistent with the timeframe for GBS caused by a C. jejuni infection. Assuming an onset of the

infection in late October, neurologic symptoms manifesting approximately a week or more from

infection (early November) was wholly consistent with the medical science on the subject. First

Bromberg Rep. at 8; J.H. Rees et al., Campylobacter Jejuni Infection and Guillain-Barré

Syndrome, 333 N. Engl. J. Med. 1374, 1376 (1995), filed as Exhibit I (ECF No. 39-9) (“Rees”)

(mean interval of nine days from diarrhea to neuropathic symptoms, with range of two to 20 days);

Richard A.C. Hughes and Jeremy H. Rees, Clinical and Epidemiological Features of Guillain-

Barre´ Syndrome, 176 J. Infect. Dis. 92, 95 (1997), filed as Exhibit J (ECF No. 39-10) (range of 5

to 21 days).

Dr. Bromberg concluded by briefly disputing some of the points Drs. Trevino and Sanchez

had made in their affidavits. Regarding Dr. Trevino’s argument about antibiotic treatment

eliminating the presence of C. jejuni, Dr. Bromberg noted the distinction between “when the

bacterium is active and pathogenic,” prior to the antibiotic’s effectiveness, and the date of onset of

neurologic symptoms. First Bromberg Rep. at 9. And the impact of antibiotic treatment would “not

cause the protein components [of the bacterium] to disappear,” thus allowing the possibility for a

molecular mimicry-mediated autoimmune response later. Id. In addition, Dr. Bromberg expressed

the view that regardless of Petitioner’s 2021 gallbladder removal (and the suggestion that this

revealed Petitioner had possibly been suffering from some form of gallbladder disease), the records

were not consistent with the conclusion that this was Petitioner’s ailment in 2016 (over four years

before). Id. And Dr. Bromberg could not find independent evidence associating the diarrheal

symptoms Petitioner had first complained of in late October 2016 and cholecystitis. Id.

Second Report

The next report offered from Dr. Bromberg commented upon Dr. Simpson’s first report.

Regarding diagnosis, Dr. Bromberg agreed that Petitioner’s electrodiagnostic study results

confirmed the presence of some form of peripheral neuropathy, despite the issues he had identified

with how the testing had been conducted. Second Bromberg Rep. at 1. But he did not accept that

the AIDP 8 form of GBS was confirmed by this testing. Id. He also opined that the results might

8

Acute inflammatory demyelinating polyneuropathy, the most common subtype of GBS. T. Adnan Alam et al.,

Electrophysiological Studies in the Guillain–Barré Syndrome: Distinguishing Subtypes by Published Criteria, 21

Muscle & Nerve 1275, 1279 (1998), filed as Exhibit M (ECF No. 59-2).

11

have been complicated by Petitioner’s medical history of diabetes. That history could produce a

neuropathy similar to what Petitioner had experienced—and the testing results were as consistent

with that cause as others. Id.

Relatedly, Dr. Bromberg took note of the fact that this testing occurred within

approximately one month of vaccination—meaning that the impact and effect of whatever had

caused Petitioner’s GBS or comparable symptoms should then have been manifest. Second

Bromberg Rep. at 1. Although the results of the testing revealed a “moderately severe” form of

neuropathy, findings associated with the needle EMG study remained inconsistent, and were not

all that reflective of an “axonal polyneuropathy.” Id. at 2. Dr. Bromberg therefore (and somewhat

inconsistent with his first report) now proposed that the EMG findings from the December 2016

testing should be “set aside,” leaving NCS results only consistent with a diabetic neuropathy. Id.

(He nevertheless thereafter assumed Petitioner could have been properly diagnosed with AMAN).

On the issue of causation, Dr. Bromberg disputed Dr. Simpson’s contention that

Petitioner’s gastroenteritis could have a viral cause (in which case the C. jejuni-GBS association

would have no bearing on cause in this case). Second Bromberg Rep. at 2. He emphasized that the

first physician to treat Petitioner for his late-October 2016 symptoms, Dr. Trevino, had seemed to

accept a bacterial cause for the symptoms, since he prescribed anti-bacterial medication (which

would be ineffective in treating a viral infection). Id. C. jejuni was widely understood in the

medical community both to cause gastroenteritis, but also to be associated with AMAN (the only

GBS variant that might be applicable to Petitioner). Id. (By contrast, what existing literature

associated GBS with the flu vaccine seemed mostly to involve AIDP, rather than AMAN). A.

Shaikh et al., Atypical Forms of Guillain-Barré Syndrome and H1N1-influenza Vaccination, 30

Vaccine 3251, 3254 (2012). 9 The record evidence overall, Dr. Bromberg opined, was mostly

consistent with a bacterial infectious cause for Petitioner’s neuropathy (to the extent it was not a

“metabolic neuropathy” that would be attributable to Petitioner’s preexisting diabetes—a

conclusion Dr. Bromberg seemed to find more credible). Second Bromberg Rep. at 3.

Third Report

Dr. Bromberg’s final filing was a two-page response to Dr. Simpson’s second written

report. He again agreed that the electrodiagnostic testing confirmed the presence of a peripheral

neuropathy, but that distinctions in the NCS findings for arms versus legs were “unusual,” despite

Dr. Simpson’s contentions that asymmetry in GBS was not unheard-of. Third Bromberg Rep. at

1. He also made some specific comments about the extent to which the “sural sparing pattern” was

as specific for GBS as Dr. Simpson maintained, noting that certain studies found it associated with

diabetic neuropathies as well. M. Bromberg and J. Albers, Patterns of Sensory Nerve Conduction

9

Respondent has not filed this article, thus there is no record citation.

12

Abnormalities in Demyelinating and Axonal Peripheral Nerve Disorders, 16 Muscle & Nerve 262,

265 (1993), filed as Exhibit N (ECF No. 59-3).

Dr. Bromberg otherwise repeated the view that the “quality of information” in Petitioner’s

electrodiagnostic testing was questionable, making it difficult to place great weight on the findings.

Third Bromberg Rep. at 3. And he contended that the mechanistic models proposed in this case

for how the flu vaccine could cause GBS could not overcome the plain fact that (a) neuropathies

post-vaccination were uncommon, whereas (b) they often occur in the absence of vaccination. Id.

III. Procedural History

The Petition was filed a little more than four years ago, and initially assigned to SPU, since

claims that the flu vaccine caused GBS are common in the Program (and more often than not

asserted as a Table claim). However, in June 2021 I ordered Petitioner to show cause why the

claim should not be dismissed, given both the evidence of the preexisting gastrointestinal infection

as a potential alternative explanation for Petitioner’s GBS, as well as the fact that the medical

records strongly suggested an onset too rapid to meet the Table’s three-day onset period. See Order

to Show Cause, dated June 9, 2021 (ECF No. 31). 10

Thereafter, however, Petitioner offered the treater statements discussed above, and noted

that fact issues existed as to the alternative cause question as well as onset. Scheduling Order,

dated July 27, 2021 (ECF No. 35). I accordingly ordered Respondent to offer expert support for

his position, and he did so with the filing of Dr. Bromberg’s first report in November 2021.

Petitioner responded with reports from Dr. Simpson, and in the course of this process I transferred

the matter out of SPU to my individual docket for final resolution. I set a briefing schedule for a

ruling on the record in the beginning of 2023, the parties made their written submissions, and the

matter is now ripe for resolution.

IV. Parties’ Arguments

Petitioner

Mr. Velasquez maintains he has met all elements for a causation-in-fact claim. He notes

that the “can cause” prong is easily met, since the flu vaccine-GBS association is well-established

(citing a prior decision of my own in support), and noting Dr. Simpson’s evidentiary showing on

the subject. Mot. at 4–5. He also argues that the second, “did cause” prong has preponderant

support. Id. at 5. He observes that Petitioner’s contemporaneous treaters (in particular Drs. Trevino

and Sanchez) concur that the vaccine was causal in this case, over other alternative explanations

10

As Chief Special Master, all SPU cases are assigned to me, although they grouped separately from the non-SPU

cases on my docket.

13

that the record reveals, such as a C. jejuni infection or diabetes-related neuropathy. Id. at 5–7, 9–

10. Petitioner had no symptoms pre-vaccination, and Dr. Bromberg’s proposed alternative causes

lack preponderant support.

A larger portion of this brief is devoted to Petitioner’s efforts to bulwark the evidence that

the onset of his GBS occurred in a medically-acceptable timeframe, measured from the date of

vaccination. In so doing, he deems his onset to have occurred “2-3 days after vaccination”— hence

outside the Table claim’s 3-42 day timeframe (although he goes to some effort to rebut the

contention that his GBS was evident at the time of vaccination, if not before, and also emphasizes

evidence consistent with the Table timeframe). Mot. at 6, 11–13. But he nevertheless argues

(relying on Dr. Simpson) that the shorter onset timeframe he likely experienced was medically

acceptable, representing that regardless of the Table claim elements, the actual, scientifically-

accepted timeframe is both shorter and longer. Id. at 6, 11. Petitioner also contends that his onset

timeframe was inconsistent with the theory that his GBS was caused by a C. jejuni bacterial

infection, noting that both Drs. Trevino and Sanchez offered medical literature establishing that

the lag from infection to onset would be no less than ten days, and hence longer than what

Petitioner experienced. Id. at 8.

Respondent

Respondent argues for the claim’s dismissal, placing greatest emphasis on the timeframe

prong as not preponderantly supported. Opp. at 9–13. He notes record evidence suggesting onset

occurred as early as the day of vaccination (since Petitioner complained that day of back pain and

leg weakness, which logically would have begun before the November 1st visit to Dr. Trevino). Id.

at 9–10. He later reported onsets that would have begun pre-vaccination, if not the day of. Id. at

10. And he disputed arguments that these symptoms were non-neurologic (for example, lower back

disc issues) as lacking record support, while also maintaining that the records generally merited

more weight than Petitioner allowed. Id. at 11–12.

Respondent offered other arguments about the timeframe of onset in this case. He rejected

Petitioner’s claim that GBS caused by gastroenteritis (in the wake of a C. jejuni infection) would

involve a longer onset timeframe, contending that in fact (assuming an onset of the bacterial

infection predated vaccination), Petitioner’s neurologic symptoms would have begun about a week

after regardless of cause—consistent with Petitioner’s own literature offered on the subject. Opp.

at 16–17. In fact, Dr. Bromberg had cited literature supporting onset of GBS in that timeframe

after such an infection. Id. at 17; Rees at 3. Petitioner’s argument that a vaccine-induced GBS

would occur in a shorter timeframe was wholly inconsistent with medical and scientific

understanding of how long it would take any autoimmune disease mediated by molecular mimicry

(vaccine or infection) to manifest symptoms—since medical science understands that a C. jejuni-

caused form of GBS will be mediate by molecular mimicry as well. Id. at 18. A too-short timeframe

14

for a molecular mimicry-mediated disease had often resulted in a claim’s dismissal. Id. at 20–21

(citing cases in which one-day timeframe was adjudged to be too short).

Otherwise, Respondent reasoned that the second causation prong could not be met.11

Strong evidence suggested, for example, that Petitioner’s GBS was associated with a

gastroenteritis infection he had experienced slightly prior to vaccination. Opp. at 14–15. Indeed,

the form of GBS he likely had experienced, AMAN, is “highly associated” with a C. jejuni

infection (which might in turn explain Petitioner’s initial gastrointestinal symptoms). Id. at 15. The

fact that it could not be shown with certainty that Petitioner had experienced such an infection was

no matter, since controlling Circuit law does not require such precise causal identification. Id. at

15–16; Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 549 (Fed. Cir. 1994) (“[t]here is

nothing in the Vaccine Act that requires a per se rule that alternative causation cannot be proved

when the specific virus is not identified.”).

V. Applicable Legal Standards

A. Petitioner’s Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that

he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—

corresponding to one of the vaccinations in question within a statutorily prescribed period of time

or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table

Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §

11(c)(1)(C)(ii)(I); see also 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, 1320 (Fed. Cir. 2006). 12

Although this matter was initially designated for the SPU (since claims that the flu vaccine can

cause GBS are common in the Program, and hence frequently can be resolved in short order),

Petitioner does not assert a flu-vaccine/GBS Table claim (given his tacit acknowledgment that

onset occurred outside the Table’s defined timeframe).

Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof.

Section 13(1)(a). That is, a petitioner must offer evidence that leads the “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, 592 F.3d at

1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture

11

Respondent also challenges the adequacy of Petitioner’s prong one showing, but for reasons discussed below, I need

not evaluate Petitioner’s success on that topic in resolving the claim.

12

Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding

authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings

concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121,

124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V,

2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

15

or speculation is insufficient under a preponderance standard). Proof of medical certainty is not

required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In

particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the

injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321

(quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999));

Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may

not receive a Vaccine Program award based solely on his assertions; rather, the petition must be

supported by either medical records or by the opinion of a competent physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a

Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal

Circuit in Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274 , 1278 (Fed. Cir. 2005): “(1) a

medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause

and effect showing that the vaccination was the reason for the injury; and (3) a showing of

proximate temporal relationship between vaccination and injury.”

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners

must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the

type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a

petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”

Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must

only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical

theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing

Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by

statute to conclusively resolve what are essentially thorny scientific and medical questions, and

thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of

the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence

standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden

placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.

Cl. at 245.

In discussing the evidentiary standard applicable to the first Althen prong, the Federal

Circuit has consistently rejected the contention that it can be satisfied merely by establishing the

proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum.

Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also LaLonde v. Sec’y of Health & Hum. Servs.,

746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply

identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of

16

proof” (citing Moberly, 592 F.3d at 1322)); Howard v. Sec'y of Health & Hum. Servs., 2023 WL

4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance for nearly four

decades”), appeal docketed, No. 23-1816 (Fed. Cir. Apr. 28, 2023). Otherwise, petitioners always

have the ultimate burden of establishing their Vaccine Act claim with preponderant evidence. W.C.

v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell

v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s

overall burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard).

The second Althen prong requires proof of a logical sequence of cause and effect, usually

supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,

569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956

F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions

and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d

at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored

in vaccine cases, as 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’”)

(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly

trustworthy evidence, since they are created contemporaneously with the treatment of the patient.

Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

Medical records and statements of a treating physician, however, do not per se bind the

special master to adopt the conclusions of such an individual, even if they must be considered and

carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,

test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y

of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates

that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and

cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the

opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their

suppositions or bases. The views of treating physicians should be weighed against other, contrary

evidence also present in the record—including conflicting opinions among such individuals.

Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious

for special master to weigh competing treating physicians’ conclusions against each other), aff’d,

698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,

2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed.

Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the

phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant

proof that the onset of symptoms occurred within a timeframe which, given the medical

17

understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan

v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what

is a medically acceptable timeframe must align with the theory of how the relevant vaccine can

cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.

Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d

mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,

2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denied (Fed. Cl. Dec. 3,

2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Legal Standards Governing Factual Determinations

The process for making determinations in Vaccine Program cases regarding factual issues

begins with consideration of the medical records. Section 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 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.” Section 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) (determining that it is within the special master's discretion to determine whether to afford

greater weight to contemporaneous medical records than to other evidence, such as oral testimony

surrounding the events in question that was given at a later date, provided that such determination

is evidenced by a rational determination).

As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as

trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95

Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his

contemporaneous medical records, the special master's decision to rely on petitioner's medical

records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.

Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked

propositions explains why such records deserve some weight: (i) sick people visit medical

professionals; (ii) sick people attempt to honestly report their health problems to those

professionals; and (iii) medical professionals record what they are told or observe when examining

their patients in as accurate a manner as possible, so that they are aware of enough relevant facts

to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,

2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.

Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to

conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).

18

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL

6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records

are often found to be deserving of greater evidentiary weight than oral testimony—especially

where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also

Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d

1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States

v. United States 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, the Federal Circuit has also noted that there is no formal “presumption” that

records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health

& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which

compelling oral or written testimony (provided in the form of an affidavit or declaration) may be

more persuasive than written records, such as where records are deemed to be incomplete or

inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any

norm based upon common sense and experience, this rule should not be treated as an absolute and

must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL

6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less

deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)).

Ultimately, a determination regarding a witness's credibility is needed when determining the

weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of

Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent, and

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,

No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the

accuracy and completeness of medical records, the Court of Federal Claims has listed four possible

explanations for inconsistencies between contemporaneously created medical records and later

testimony: (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, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making

a determination regarding whether to afford greater weight to contemporaneous medical records

or other evidence, such as testimony at hearing, there must be evidence that this decision was the

result of a rational determination. Burns, 3 F.3d at 417.

19

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present

expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,

1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the

factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509

U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.

Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).

Under Daubert, the factors for analyzing the reliability of testimony are:

(1) whether a theory or technique can be (and has been) tested; (2) whether the

theory or technique has been subjected to peer review and publication; (3) whether

there is a known or potential rate of error and whether there are standards for

controlling the error; and (4) whether the theory or technique enjoys general

acceptance within a relevant scientific community.

Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).

In the Vaccine Program the Daubert factors play a slightly different role than they do when

applied in other federal judicial settings, like the district courts. Typically, Daubert factors are

employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence

that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are

used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &

Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have

been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of

expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88

Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not

been employed at the threshold, to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts in order to rebut a petitioner’s case.

Where both sides offer expert testimony, a special master's decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion

“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743

(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.

Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for

20

review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo,

617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on

a particular expert's credibility, is part of the overall reliability analysis to which special masters

must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26

(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);

see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court

has unambiguously explained that special masters are expected to consider the credibility of expert

witnesses in evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Both parties filed numerous items of medical and scientific literature in this case, but not

all such items factor into the outcome of this decision. While I have reviewed all the medical

literature submitted in this case, I discuss only those articles that are most relevant to my

determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed

every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072,

2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e 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) (“[f]inding certain information not relevant does not lead to—

and likely undermines—the conclusion that it was not considered”).

E. Standards for Ruling on the Record

I am resolving Petitioner’s claim on the filed record, and the parties have not challenged

my determination to do so. Mot. at 1. The Vaccine Act and Rules not only contemplate but

encourage special masters to decide petitions on the papers where (in the exercise of their

discretion) they conclude that doing so will properly and fairly resolve the case. Section

12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been

affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.

2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21

n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided

case on the papers in lieu of hearing and that decision was upheld). I am simply not required to

hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health

& Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his

discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health &

Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).

21

ANALYSIS

I. Petitioner Has Not Met His Prima Facie Burden of Proof

Petitioner has not alleged a Table claim in this case. In fact (and despite Dr. Simpson’s

representations of a three-day onset as supported by the record) he could not successfully maintain

one. The medical records preponderantly establish that onset occurred less than three days after

vaccination—thus sooner than the timeframe provided for by the Vaccine Injury Table. 42 C.F.R.

§ 100.3. And Petitioner does seem to accept that the evidence preponderates in this direction. Mot.

at 21 (“the vast majority of the references place the onset of symptoms after the flu vaccine, with

most stating 2-3 days after vaccination” (emphasis added)).

Petitioner nevertheless argues that he can establish causation under the three prongs set by

the Federal Circuit in Althen. But I cannot agree the record supports the claim. Resolution of this

matter primarily turns on the third and second Althen prongs (and I address them in that order,

given their relative importance). 13

First, the timeframe prong has not been satisfied. Petitioners seeking to prove GBS was

caused by the flu vaccine on a “non-Table” basis, as here, are of course not formally limited by

the Table’s 3-42 day onset period. Nevertheless, this timeframe best captures the most likely

period in which vaccine-caused GBS would begin, based on the most persuasive and reliable

science. See Rowan v. Sec'y of Health & Hum. Servs., No. 17-760V, 2020 WL 2954954, at *14–

16 (Fed. Cl. Spec. Mstr. Apr. 28, 2020) (discussion of the relationship between Table requirements

and non-Table claims in context of flu-GBS claims).

Thus, petitioners seeking to prove a medically acceptable timeframe for flu vaccine-caused

GBS as shorter than three days post-vaccination have their work cut out for them. Only where

other factors suggest some synergistic combination of causes has a flu vaccine been deemed a

“substantial factor” in producing GBS so rapidly—but in most cases this cannot be accomplished.

See, e.g., Orton v. Sec'y of Health & Hum. Servs., No. 13-631V, 2015 WL 1275459 (Fed. Spec.

Mstr. Cl. Feb. 23, 2015) (dismissing claim where inadequate evidence established the medical

13

There is little dispute in the Vaccine Program that the flu vaccine “can cause” GBS, and hence I deem the first

Althen prong satisfied (although that is not enough to save the claim, since all three prongs must be met for entitlement

to be found). Respondent raised some fair points against that conclusion, but I am reluctant to give them significant

weight—for the same policy reasons I am unpersuaded by Dr. Simpson’s efforts to “stretch” the timeframe set by the

Table for onset. Although it is often the case in the Vaccine Program that failed Table claims are deemed potentially

viable as causation-in-fact claims, special masters should not disregard the science that led the Government to adopt

the contours of the comparable Table claim in the first place. By allowing a Table claim, the Government is giving

weight to the scientific evidence supporting the conclusion that the flu vaccine might be causal of GBS in some cases.

That determination is not appropriately disregarded or ignored simply because other aspects of the Table claim cannot

be met.

.

22

acceptability of a one-day onset of GBS); Rowan, 2020 WL 2954954, at *19 (dismissing claim

because it did not demonstrate 30-36 hour onset in elderly petitioner). They cannot prevail simply

by making the blanket assertion (as Dr. Simpson does) that the 3-42 day period is itself imprecise

or too limited. This amounts to asking the special master to create a “side Table,” in which longer

or shorter onsets are deemed as medically acceptable as what already exists, but without any

showing specific to the claimant’s circumstances that would justify stretching the Table timeframe.

Accordingly, Petitioner needed to offer persuasive and reliable evidence for why in this

case a shorter onset would make medical “sense.” Dr. Simpson’s opinion does not accomplish this.

Petitioner’s experts instead seemed to embrace the idea that the timeframe for an infectious cause

of GBS (such as via C. jejuni) would inherently be longer than a few days, ruling out that infection

as causal. See, e.g., Sanchez Rep. at 2.

But what is it about the nature of vaccination supporting the conclusion that causation could

occur in even less time than a wild infection? 14 This is an unanswered question—and one that is

not even well-founded, given that vaccines are engineered to promote a controlled immune

response less harmful than what a live viral or bacterial infection would cause. Indeed, the flu

vaccine at issue is not adjuvanted—it does not contain alum or some comparable agent intended

to boost the immune response. Dougherty v. Sec'y of Health & Hum. Servs., No. 15-1333V, 2018

WL 3989519, at *14 (Fed. Cl. Spec. Mstr. July 5, 2018), aff'd, 2018 WL 7022203 (Fed. Cl. Dec.

28, 2018) (all expert witnesses agreeing that no flu vaccines administered in the US contain

adjuvants). Thus, the immune response it triggers will, inherently, be even less robust than

vaccines containing an adjuvant—reducing the power of the response, and perhaps in some cases

even slowing the immune reaction. I have noted in comparable cases that this is why different

versions of the flu vaccine are administered to certain populations (in particularly, the elderly): to

make up for the fact that the straightforward, inactivated formulation lacks sufficient

immunogenicity for those groups. Rowan, 2020 WL 2954954, at 7.

Otherwise, the articles filed in this case do not establish an onset of less than three days is

likely, as I have noted in other matters. See, e.g., Rowan, 2020 WL 2954954, at 16 (discussion of

Schonberger’s applicability to vaccine injury claims). Certainly these articles do not support the

conclusion that vaccine-caused GBS will occur in a faster timeframe than a wild infection.

Also relevant to my determination is the manner in which infections (and some vaccines)

are thought to cause GBS. The proposed mechanism by which the flu vaccine (or bacterial

infections like C. jejuni) can cause an autoimmune-mediated peripheral neuropathy, molecular

14

In fact, an onset closer-in-time to vaccination in this case is more supportive of an infection (bacterial or viral) as

causal. The medical record clearly establishes that Petitioner’s gastrointestinal symptoms predated vaccination – and

so any autoimmune-mediated process had even longer to begin (when measuring from Petitioner’s first symptoms

manifestation) than what the vaccine could have caused.

23

mimicry, involves an adaptive immune response that more often than not is expected to take well

more than three days to occur. Forrest v. Sec'y of Health & Hum. Servs, No. 14-1046V, 2019 WL

925495, at *6 (Fed. Cl. Spec. Mstr. Jan. 28, 2019) (detailed discussion of timeframe for molecular

mimicry, and production of antibodies in reaction to a vaccine’s antigens). No other persuasive

evidence was offered suggesting it is otherwise for the flu vaccine. And I have in other cases noted

that articles like Park reveal only that another country’s vaccine compensation program paid

damages in cases of short onset, with no discussion of whether such an onset had scientific or

medical support. See, e.g., Block v. Sec'y of Health & Hum. Servs., No. 19-969V, 2021 WL

2182730, at *5, 8–9 (Fed. Cl. Spec. Mstr. Apr. 26, 2021) (dismissing flu-GBS Table claim due to

onset occurring outside the defined 3-42 day timeframe, and discussing Korean vaccine injury

program referenced in Park). 15 This is hardly robust proof that a short onset is medically

acceptable.

At bottom, numerous decisions in the Program have ruled that in cases alleging molecular

mimicry as the immune-mediated mechanism for disease, an onset of less than three days is too

short to find the vaccine causal. See Opp. at 20 (list of cases in which claims of one-day onset were

rejected).

The second, “did cause” prong is also unsatisfied. There is no evidence of any suspicious

vaccine reaction that could suggest an aberrant immune response had begun. No testing or clinical

observations make causation by vaccine likely. And there is some, admittedly equivocal, evidence

that Petitioner’s post-vaccination neuropathic symptoms may have reflected complaints about pain

and leg weakness he was not only experiencing before November 1st, but the same day as

vaccination. Ex. 2 at 16. (This kind of evidence also suggests the possibility of a pre-vaccination

onset, 16 although I have found the record preponderates otherwise).

By contrast, although contemporaneous treaters like Drs. Trevino and Sanchez do opine

that the vaccine was causal, their opinions are either conclusory in nature (especially so for Dr.

Sanchez) or over-rely on a purported distinction for the timeframe of infection-caused GBS versus

vaccine-caused that lacks reliable scientific support. And I am not otherwise obligated to accept

their opinions at face value merely because they treated Petitioner, but may weigh them against

not only contrary evidence, but their own internal reliability. Snyder v. Sec'y of Health & Hum.

Servs., No. 01-162V, 2009 WL 2569773 at n.67 (Fed. Cl. Spec. Mstr. Aug. 11, 2009) (“[h]owever,

there is nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it

must be accepted in its entirety and cannot be rebutted”). Here, these opinions are not especially

probative of causation.

15

Block also involved an expert opinion from Dr. Simpson. Block, 2021 WL 2182730, at *5.

16

See, e.g., Ex. 3 at 9 (reporting onset at ED or symptoms beginning a week before the November 4, 2016 treatment

visit).

24

Another issue with establishing the flu vaccine caused Petitioner’s GBS is the ample

evidence of an alternative explanation for his injury: the gastrointestinal infection. Although

Program claimants are never obligated to “rule out” alternative explanations for an injury, evidence

of competing explanations (especially when self-evident from the medical record—as here) is

highly relevant to evaluation of the “did cause” prong. Too much evidence of such explanations

can often fairly undermine a claimant’s evidentiary showing. See Winkler v. Sec'y of Health &

Hum. Servs., 88 F.4th 958 (Fed. Cir. 2023).

Here, it is incontrovertible that Petitioner had a number of preexisting comorbidities that

could cause neuropathic symptoms, like diabetes—and that were not well-controlled at the time of

vaccination. See, e.g., Ex. 2 at 14, 16. On top of that, Petitioner had been treated in the days before

vaccination for gastroenteritis. Id. at 19. He received antibiotics for it, suggesting the view (at least

at the time) that its cause was bacterial—and there is a well-known association between a specific

kind of bacterial infection, C. jejuni, and the AMAN form of GBS Petitioner likely experienced.

See Opp. at 15.

It is true, as Petitioner notes, that the precise nature of the GI infection was never identified

(although as already noted such a competing causal factor need not be proven for the mere fact of

the ailment to undermine causation). Knudsen, 35 F.3d at 549. It could have been viral (though that

would not prevent the determination that it caused Petitioner’s GBS). And the infection is not

necessarily C. jejuni simply because Petitioner’s form of GBS was AMAN. More compelling is

Petitioner’s contention (primarily advanced by Dr. Trevino) that in retrospect these symptoms

could have been misconstrued, and might instead have reflected a gallbladder issue that was at the

time not known.

All of these competing factors somewhat reduce the strength of Respondent’s rebuttal of

the second prong—although there is enough evidence in the record on this point to find that

Petitioner has not preponderantly shown that the flu vaccine Petitioner received likely played a

substantial role in his GBS. And even if he had met his burden on this single prong, the established,

too-fast onset would remain a primary basis for denying entitlement—since that question was not

preponderantly established in Petitioner’s favor to any degree.

CONCLUSION

A Program entitlement award is only appropriate for claims supported by preponderant

evidence. Here, Petitioner has not made such a showing. Petitioner is therefore not entitled to

compensation.

25

In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the

Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision. 17

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

17

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices

renouncing their right to seek review.

26