In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 15-095V

(to be published)

* * * * * * * * * * * * * * * * * * * * * * * * * Special Master Corcoran

*

GLORIA MASSEY CHINEA, *

*

Petitioner, * Filed: March 15, 2019

*

v. * Decision; Influenza (“flu”)

* Vaccine; Guillain-Barré

SECRETARY OF HEALTH * syndrome (“GBS”); Onset

AND HUMAN SERVICES, *

*

Respondent. *

*

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

Lisa A. Roquemore, Law Office of Lisa Roquemore, Rancho Santa Margarita, CA, for Petitioner.

Christine M. Becer, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION DENYING ENTITLEMENT1

On October 9, 2015, Mrs. Gloria Chinea filed a petition seeking compensation under the 

National Vaccine Injury Compensation Program (“Vaccine Program”).2 Petitioner alleges that she 

experienced Guillain-Barré syndrome (“GBS”) due to receipt of the influenza (“flu”) vaccine on 

October 31, 2012.

An entitlement hearing was held on August 6-7, 2018. For the reasons stated in more detail

below, Petitioner has not demonstrated entitlement to compensation under the Vaccine Program.

 

1 This Decision has been formally designated “to be published,” and will be posted on the Court of Federal Claims’s 

website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will 

be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the 

parties may object to the Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine 

Rule 18(b), each party has fourteen 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 Decision in its present form will be available. 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).
2

The medical records in this case support the conclusion that Petitioner’s GBS symptoms began in

late January 2013 – well outside the six to eight-week timeframe from vaccination that Program 

decisions recognize as medically reasonable. Through her own testimony as well as that of several 

credible fact witnesses, Petitioner has established that in the fall of 2012, she was more likely than 

not experiencing fatigue and other symptoms that were negatively impacting her health and quality 

of life. But Petitioner has not established (via expert testimony or otherwise) that those symptoms 

had any relationship to her subsequently-diagnosed GBS, or that the October 2012 vaccination

initiated a slow, “smoldering” form of GBS, given the extent to which her late fall symptoms were 

inconsistent with GBS’s typically acute presentation.

I. Factual Background – Medical Record

The evidentiary record in this case consists of Mrs. Chinea’s medical records, the testimony 

and sworn statements of multiple fact witnesses and two experts, plus the medical or scientific 

literature submitted by the parties in support of their respective positions. I have reviewed the 

entire record as required by the Vaccine Act. Before discussing fact witness testimony, I will 

recount what the medical record reveals in this case.

Petitioner’s Pre-Vaccination Health

Mrs. Chinea was born on July 7, 1956. Before the time period in dispute, she was a

generally healthy woman for her age with only minor health issues, such as high cholesterol (which 

was successfully treated), some hypertension, asthma and allergies, type 2 diabetes, and 

conductive hearing loss. Ex. 1 at 33. However, the record does establish that in the year prior to 

the October 2012 vaccination, she experienced a number of symptoms congruent with those at 

issue in this case. Thus, on May 31, 2011, Petitioner presented to her primary care physician (Dr. 

Sergio Neira) with complaints of blurred vision, impaired hearing, urinary incontinence, and leg

pain, and continued to experience these symptoms into the late summer that year. Ex. 1 at 30, 33. 

Her assessment included hypertension, menopausal syndrome, and included a screening for 

tuberculosis. Id. at 31.

On May 10, 2012, Petitioner returned to Dr. Neira complaining of depression, stress, and 

premenstrual tension syndrome. Ex. 1 at 21. Her physical examination was normal, however, and 

the overall assessment was consistent with her past diagnosed health problems (i.e., hypertension 

and high cholesterol). Id. On July 25, 2012, Mrs. Chinea presented to Dr. Neira complaining of a 

rash (with associated burning and extreme fatigue). Id. at 18. She was diagnosed with shingles and 

placed on acyclovir and prednisone. Id. at 19-20. Petitioner was also treated for post-herpetic 

neuralgia on August 9, 2012. Id. at 15.
3

Vaccination and Immediate Aftermath

On October 31, 2012, Mrs. Chinea went back to Dr. Neira for a routine appointment. She 

reported some wheezing due to allergens. Ex. 1 at 11. In addition, her then-current problems were 

listed as conductive hearing loss, fatigue, and post-herpetic neuralgia (consistent with her prior 

diagnoses). Id. at 12. She received the flu vaccination (Fluvirin, lot #1205001) in her left deltoid 

as part of her general health maintenance. Id. at 1, 43. There is no subsequent medical record 

setting forth any purported reaction to this vaccination, and nothing from the month of November 

that would corroborate the allegations of any adverse symptoms around this time.

Nearly six weeks later, on December 10, 2012, Petitioner saw her gynecologist, Dr. 

Adrienne Lara, for an annual exam. Ex. 4 at 3. The record from this visit indicates that Dr. Lara’s 

review of symptoms was normal. Id. at 4. In particular, she did not record any complaints by 

Petitioner of weakness, fatigue, or anything else that might appear a precursor of GBS as 

classically understood (e.g., paresthesias, numbness of tingling in the limbs, difficulty walking, 

etc.). See id. Records from this visit explicitly state that Petitioner “continues to be successful and 

it is going to be a good year. There was nothing else on her mind.” Id. On December 11, 2012, 

Petitioner had an endometrial biopsy. Id. at 2. Later that month, on December 21, 2012, she had a 

follow-up to get the results of the biopsy. Id. at 1. No additional complaints were noted at that time

either. Id.

GBS Presentation

There is another, almost one-month records gap before Petitioner next saw a medical treater 

– but this next set of records is what best establishes Petitioner’s GBS and how it presented. Thus, 

on January 28, 2013, Petitioner began to experience “profound[] weakness,” plus other adverse 

symptoms (headaches, dizziness, balance issues, congestion, and voice problems) sufficient to be 

alarming to her and her husband, Mr. Rolando Chinea. Ex. 7 at 4; Ex. 1 at 40. At first, Petitioner 

simply sought treatment from Dr. Neira. Ex. 1 at 39-40. The record reveals that Petitioner’s 

husband telephoned Dr. Neira’s office on January 30, 2013, to report the above-noted symptoms

and obtain a Tamiflu prescription. Id. at 40. But by January 31, 2013, the Chineas were concerned 

enough about Petitioner’s health to seek urgent care intervention, and Mrs. Chinea was taken to 

the emergency room at Community Memorial Health System. Ex. 7 at 4.

There, Petitioner was evaluated by a neurologist, Dr. Paul Vespa, at which time her chief 

complaint was “generalized weakness.” Ex. 7 at 4. Petitioner specifically reported that she began 

experiencing upper respiratory symptoms about eleven days prior (meaning no earlier than midJanuary). Id. But before onset, Petitioner reported being in generally good health, able to complete 

her normal exercise classes and take hour-long walks around the neighborhood in the days prior. 
4

Id. at 8, 10. It was also noted that Petitioner had a history of asthma/cat allergies, and that in the 

two weeks prior, she had been exposed to a cat (which resulted in congestion/conjunctivitis/rhinitis 

that “lasted for several days”). Id. at 6, 7-8. After this exposure, she experienced shortness of breath 

about one week later, then profound weakness in the two to three days prior to admission. Id. She 

stated that she had lost her voice, was unable to walk or hold her head up, and had impaired 

sensation in the hands and feet. Id. Her physical examination was significant for slurred speech, 

slow movements in all four limbs, absent deep tendon reflexes, and decreased muscle strength (3/5 

bilateral in both upper and lower extremities). Id. at 5. She also had paresthesia of the hands and 

feet. Id. Lab reports indicated negative testing for the influenza A and B virus. Id. at 4.

Petitioner was diagnosed with acute respiratory failure with upper airway edema and 

diffuse neuromuscular weakness. Ex. 7 at 7-8. Her medical records indicate that she was intubated 

and placed on ventilator support thereafter. Id. Petitioner was evaluated by another neurologist, 

Dr. Francisco Torres, on February 1, 2013. Id. at 10. In his consult, Dr. Torres indicated that 

Petitioner was in her “usual state of health” until January 28, 2013, with congestion, imbalance, 

and flu-like symptoms manifesting on the 29th (and thus immediately prior to her ER presentation). 

Id. Upon exam, her deep tendon reflexes were absent. Id. at 11. Lower extremities were noted to 

have normal distal strength. Id. Upper extremities were described as 2/3 in the deltoids, with 3+ to 

4/5 in the biceps and triceps. Id. Dr. Torres opined that Petitioner had GBS given her history of 

flu-like symptoms, although he also included myasthenia gravis and botulism in the differential 

diagnosis. Id.

Mrs. Chinea remained hospitalized for several days thereafter. She tested positive for the 

GQ1B antibody (which as discussed below is associated with the form of neuropathy with which 

Petitioner was subsequently diagnosed). Ex. 7 at 52-52, 71-72. Following this confirmation, she 

was treated with a five-day course of IVIG. Id. at 1-2. She was extubated on February 15, 2013, 

and was monitored thereafter for treatment success. Id. at 2. Her final hospital diagnosis was 

determined to be GBS, Miller-Fisher variant. Id. On February 26, 2013, Petitioner was discharged 

and transferred to St. John’s Regional Medical Center for acute inpatient rehabilitation, where she 

remained for approximately one month. Ex. 7 at 2; see also Ex. 6 at 10. She was discharged on 

March 23, 2013, having made “excellent progress.” Ex. 6 at 10. By this time, Petitioner was able 

to ambulate with the use of a walker and climb steps, although she continued to have some 

dysphagia and pain upon discharge. Id.

Identification of Flu Vaccine as Possibly Causal of Petitioner’s GBS

Throughout the spring and summer of 2013, Mrs. Chinea continued to receive treatment 

for her GBS and the unresolved sequelae she was experiencing from it (which included ongoing 

paresthesias, weakness, and pain). See, e.g., Ex. 1 at 7-10; Ex. 3 at 9, 11-14. Prior to this time, the 
5

records do not include any notation in which a treater proposed that the flu vaccine Petitioner had 

received the prior fall had any association with her GBS symptoms beginning in January 2013.3

However, at a June 2013 visit with Dr. Neira, Petitioner stated “MD at hospital told her she had an 

adverse reaction to [the] [i]nfluenza vaccine.” Ex. 1 at 7. Dr. Neira and Petitioner specifically

discussed at this time her seeking legal counsel concerning a reaction to the flu vaccine. Id. at 9. 

At a follow-up visit on October 17, 2013, Dr. Neira’s notes indicated that Petitioner’s GBS “may 

have been caused by [the] flu vaccine[,]” but included no additional comments concerning the 

onset of symptoms. Id. at 73. He also seemingly recommended that Petitioner not receive the flu 

vaccine in the future. Id. at 77 (“other orders: [n]o flu vaccine ever”). 

On June 24, 2013, Dr. Neira submitted a VAERS report on Petitioner’s behalf. Ex. 2 at 1-

3. Dr. Neira noted the vaccination date as October 31, 2012, and the adverse event date as January 

31, 2013. Id. at 2. However, the report was modified on January 28, 2014, with additional 

information emailed to VAERS by an employee from Dr. Neira’s office. Ex. 10 at 17. The new 

submissions indicated that Petitioner had actually experienced associated fatigue prior to 

Thanksgiving 2012 (i.e., “experienced different exhaustion than before”), as well as weakness, 

blurred vision, voice hoarseness, and “difficulty lifting left arm.” Id. The VAERS report was 

updated a second time on July 17, 2014. Ex. 9 at 1-5. It now included an attached list of residual 

GBS symptoms that Dr. Neira reported were associated with Petitioner’s receipt of the flu vaccine, 

along with a summary of the treatment and therapy she received. Id. at 3-4, 5. However, no 

correction was made to the reported symptom onset date of January 31, 2013. See id. at 1-5.

By September and December 2013, Petitioner’s treaters felt that she had mostly recovered 

from her GBS. Ex. 3 at 15-17. She nevertheless continued to attend physical therapy throughout 

2013 and 2014. Ex. 10 at 14. 

II. Fact Witness Testimony

A. Mrs. Gloria Chinea

Petitioner was the first witness to testify at hearing. Tr. at 5-102. Her testimony largely 

consisted of her own recollection of her overall health history, pre- and post-vaccination, with 

some additional explanation of disputed issues relevant to certain medical records.

 

3 The health history taken upon Petitioner’s presentation to the hospital on January 31, 2013, indicated that she “did 

receive a flu shot this season.” Ex. 7 at 4. However, the intake physician did not opine as to any causal connection 

between her symptoms and the vaccine. See id. Apart from this one reference, it does not appear that any other hospital 

treater considered the vaccine to be causative of her onset of GBS. See generally Ex. 7. 
6

Mrs. Chinea began by describing her educational and employment background. She 

received a bachelor’s degree in nutrition and dietetics, followed by a master’s in public health. Tr. 

at 6. Following graduate school, she worked as a health education specialist at St. John’s Regional 

Medical Center in Oxnard, California. Id. She retired from the hospital after twenty-one years of 

service and worked briefly at a home mortgage firm thereafter. Id. at 6-7. In 2009, Petitioner 

opened Alma Joy Villa, a residential care facility for the elderly, and serves as its Director of 

Activities. Id. at 7, 17. 

Prior to her receipt of the flu vaccine, Petitioner testified that she was in “excellent” health. 

Tr. at 16. She attended church each morning and typically arrived to work around 7:00 AM. Id. at 

16-17. Petitioner stated that her days at Alma Joy Villa were busy, given that she was involved in 

all aspects of patient care (including cognitive exercises, physical care, and attending meetings 

with caretakers and physicians). Id. at 17. She also routinely participated in outdoor activities 

(including walks with her dog and going to the gym) and was able to complete various household 

tasks such as grocery shopping and cooking meals. Id. at 18. She felt like the “energizer bunny 

rabbit.” Id. at 19. Petitioner specifically denied experiencing any significantly adverse health 

problems or extreme fatigue prior to receiving her vaccination (despite the record evidence set 

forth above recording some symptoms that echo those alleged to have been experienced in the fall 

of 2012). Id. at 63-64.

4

Following receipt of the flu vaccine on October 31, 2012, Petitioner maintains that she 

began to notice a “lack of energy” roughly “a week or two” following vaccine administration (or 

between the first and second week of November 2012). Tr. at 19, 52, 80. In particular, she recalled 

feeling fatigued and sleepy (i.e., taking naps) which was unusual for her. Id. at 19, 80. She also 

reported “feel[ing] low” and having pain in her vaccinated arm. Id. at 20 (arm “feels warm”), 21, 

81-83.

5 She testified that the arm pain lasted until her January 2013 hospitalization and was 

accompanied by a raised bump (or “mark” on the arm) and redness. Id. at 82-83. Apart from the 

above, Petitioner denied experiencing any other problems at this time (for example, cold 

symptoms). Id. at 21. In support of the above, Petitioner referenced phone records (Ex. 74) from 

one of her patient’s relatives (Dr. Diane Moore, who also testified at hearing). Id. at 21-23. 

According to Petitioner, such records reveal that she was a “no-show” to a meeting scheduled to 

 

4 On cross examination Respondent pointed to a record dated July 25, 2012, which indicated that Mrs. Chinea had 

presented to a nurse practitioner at Dr. Neira’s office with possible shingles and had specifically reported “still” feeling

“extremely fatigued” at that time. Tr. at 85-84 (citing Ex. 1 at 18). Petitioner, however, maintained that this record 

was an inaccurate description of how she was actually feeling that day. Id. at 86 (“I did not tell her that I had what you 

read me, extremely fatigued”). Petitioner otherwise stated the fatigue she felt in July 2012 was distinguishable from 

what she felt following her receipt of the vaccine. Id. at 85. 

5 At hearing, Petitioner recalled a meeting with her Bible study group when she asked for prayer to restore her formerly 

high energy level. Tr. at 20. 
7

take place with Dr. Moore on November 14, 2012, because she overslept. Id. at 23. Following the 

missed meeting, Petitioner reported she continued to feel tired and experience hoarseness. Id. at 

24. She could not, however, reference medical records corroborating these allegations. 

Mrs. Chinea next testified about the progression of her symptoms over the 2012 

Thanksgiving holiday. Petitioner described her typical Thanksgiving as a big family event filled 

with cooking and preparing meals for the homebound, as well as assisting with celebrations at 

Alma Joy Villa. Tr. at 24-25. However, that year she “didn’t have much energy,” felt tired and 

achy, and was unable to participate in the above-mentioned activities.6Id. at 26, 100-02. She was 

also purportedly experiencing at this time heightened sensitivity to touch, a sensation of an 

“overgrown” tongue, and “taste of metal” in her mouth. Id. at 26-27, 100. And she began to have 

trouble swallowing, now preferring a bland diet filled with liquids or soft foods. Id. at 27-28.7In 

addition, she started experiencing leg jerks at night, plus blurred vision when looking at a computer 

screen, along with a lack of hand strength when attempting to open bottles or coffee containers, 

and felt “intermittent” tingling in her hands and toes. Id. at 28-29, 100. 

Because she did not feel up to hosting her own Thanksgiving celebration, Petitioner 

attended Thanksgiving 2012 at the home of a family friend, Dr. Arturo Sidransky. Tr. at 30. Other 

friends were in attendance as well, including Ms. Enjoli Flores. Id. Petitioner did not have much 

appetite and recalled that she was “quiet” and felt “tired” throughout the evening. Id. at 31. 

Petitioner also stated that she was unable to participate in post-Thanksgiving “Black Friday”

shopping that year due to her fatigue/tiredness (an activity that she usually looked forward to). Id.

at 32-33. 

Petitioner provided some detailed testimony regarding her aforementioned visit to her

OB/GYN, Dr. Lara, in December 2012. Tr. at 33-34. In addition to the need for routine testing, 

Petitioner testified that she was experiencing adverse gynecological symptoms (including vaginal 

discharge and bleeding) which prompted the visit. Id. at 34. Contrary to the original medical 

records from this visit, however (which make no mention of any non-gynecologic symptoms, and 

even suggest that Petitioner was in her usual health overall), Petitioner testified that she also 

discussed her feelings of tiredness and lack of energy8 with Dr. Lara (along with a concern for an 

 

6 Petitioner also stated her tiredness caused her to be less active (i.e. she could not complete her routine exercise classes 

at the 24-Hour Fitness gym). Tr. at 81.

7 At the same time, however (and somewhat contradictorily to the foregoing), she also began to eat spicy food which 

was unusual for her. Tr. at 28 (“I noticed I was eating more Cholula [a hot sauce].”). 

8 On cross, Petitioner stated that she was acquainted with Dr. Lara through her professional activities prior to December 

2012. Tr. at 70-72. Thus, in her view, Dr. Lara would have been well aware of her typical energy level.
8

iron deficiency, sleepiness, loss of appetite, swollen mouth, and issues with body temperature). Id.

at 34, 38, 96-97.

To support her contentions that she did in fact inform Dr. Lara of the non-gynecologic 

symptoms she was experiencing at that time, Petitioner maintained that she had prepared notes 

about her medical health in anticipation of this visit, asserting that this was her common practice, 

and offered these notes into evidence at hearing (although they were never previously identified 

as existing prior to that moment). Ex. 82 and 83; Tr. at 34-35 (“[i]t is my tradition that I usually 

take notes . . . things that I need to talk about.”), 37-38, 67-68, 78-79.

9 Petitioner testified that she 

tearfully expressed the above-mentioned problems to Dr. Lara who listened “attentive[ly]” and 

recommended a follow-up appointment (along with “more testing”).10 Tr. at 39, 78-79. Petitioner 

otherwise proposed that she may have downplayed how she then felt because she had always been 

a “very positive person.” Id. at 40 (“even though I probably felt the way I felt, I knew that a new 

year was coming and that things . . . w[ere] going to get better”).11

Following her visit with Dr. Lara in December 2012, Petitioner testified that she scheduled 

an appointment with Dr. Neira for February 2013 (to discuss her overall condition and symptoms). 

Tr. at 45. She was unable to keep that appointment, however, due to her onset of GBS. Id. Upon 

further questioning, Petitioner stated that she did not seek an earlier appointment with Dr. Neira 

because she thought her symptoms of tiredness and voice hoarseness would resolve on their own. 

Id. at 46 (“I felt that they were going to go away because I didn’t have a fever, didn’t have diarrhea, 

 

9 On cross, Petitioner attempted to account for the eve-of-trial discovery of this evidence, maintaining that she located 

the personal health agenda from the Dr. Lara appointment on or about Thursday evening prior to hearing (or August 

2, 2018). Tr. at 66. She purported to have been searching for the notes, but had been unable to locate them. Id. at 66-

67. Petitioner could not explain why she did not bring the agenda to Dr. Lara’s deposition, however, or why her 

January 24, 2015, declaration did not reference their existence. Id. at 67. 

10 It is not clear if the additional testing or follow-up were intended to address Petitioner’s symptoms related to fatigue 

or her gynecological symptoms. See Tr. at 39. 

11 Given reasonable questions about the discovery of this evidence, I cautioned Petitioner that her personal health 

agenda/notes would need to be filed and properly authenticated, along with any evidence that would corroborate the 

date of their creation. Tr. at 94-95, 99. I also asked Petitioner some questions about the manner in which this evidence 

might have been maintained. In response, Petitioner testified that she typically produced her notes on a personal 

computer, although she could not access the notes electronically (something that might establish, via a file time stamp, 

when the document actually was created) because the computer had since crashed. Id. at 91, 94. 

 Following the hearing, on September 11, 2018, Petitioner filed various pieces of evidence attempting to 

authenticate her notes. Analysis of her hard drive completed by Mr. Chinea confirmed that no data could be retrieved 

concerning the date the document was created. See Ex. 87 at 3. Petitioner also filed examples of similarly created 

health agendas (some hand written and some typed), as well as a photo of the “pink binder” in which she located the 

agenda pertaining to Dr. Lara’s visit. Tr. at 66; see Ex. 84; Ex. 85; Ex. 86 (example of Dr. Neira appointment agenda). 

Petitioner and her husband otherwise filed additional declarations attesting to the reliability of the above-described 

exhibits. See Ex. 88 and 89.
9

I didn’t have – I was not vomiting, I was not – I just felt really tired, and my voice was raspy. So 

I thought it’s gonna be taken away”). On cross, however, Petitioner acknowledged that she could 

have scheduled an appointment with Dr. Neira sooner if she had been experiencing a more 

concerning problem. Id. at 68-69. 

Petitioner went on to testify about additional occurrences in December 2012-January 2013 

that in her view corroborated her allegations of post-vaccination symptoms. In December 2012, 

Petitioner attended a dinner with friends and family at Outback Steakhouse. Tr. at 46-47.12

Petitioner described choking on a small piece of meat. Id. at 47 (“I couldn’t get – dislodge the 

piece of meat.”). Then, over the Christmas holiday, Petitioner described similar feelings of 

sleepiness/tiredness, along with problems regulating her temperature. Id. at 48 (“My hands were 

cold. My – my legs were cold. My feet were cold.”), 49-50. The end of the following month, just 

prior to her hospitalization, Petitioner recalled attending a book signing event for Dr. Moore (who 

had written a guide for seeking assisted living care for elderly relatives). Id. at 50-51. Mrs. Chinea

had been invited to speak at the event, but stated she had trouble completing her speech due to 

voice irritation. Id. at 51 (“My voice was totally – it was gone, was very very raspy, very deep.”). 

Petitioner presented to the emergency room on January 31, 2013, with complaints similar 

to those discussed above (including sleepiness, trouble swallowing, and temperature problems). 

Tr. at 55, 86-88. She testified that she could not walk or stand at the time of arrival, and thus had 

to be brought into the hospital by wheelchair. Id. at 55. She recalled experiencing sleepiness, 

“shallow breaths[,]” low oxygen, as well as an inability to speak. Id. at 55 (“I lost my voice.”), 56. 

As a result, Mr. Chinea was primarily responsible for communicating with her treaters. Id. at 58. 

She was intubated thereafter and experienced additional symptoms (including paralysis). Id. at 59. 

As already mentioned in the review of the contemporaneous medical records, Petitioner’s 

emergency room intake records set forth that Petitioner had been in her “normal state of health” 

until roughly one week prior to her January 31, 2013, presentation. Tr. at 60. At hearing, however, 

Petitioner maintained that such references in the record were inaccurate. Id. Rather, Petitioner 

testified, she had been experiencing milder forms of the symptoms that led to her hospitalization 

throughout the fall and early winter. Id. at 60-61, 63-64. In particular, she denied experiencing 

allergies, brought on by exposure to a cat in the two weeks before her hospitalization. Id. at 61, 63. 

She also maintained that her “throat” symptoms/voice hoarseness were unrelated. Id. at 62-63. At 

times, however, Petitioner acknowledged that her earlier-in-time symptoms could have been 

related to her pre-existing allergies/asthma. Id. at 83. Overall, apart from her own inability to 

communicate, Petitioner could not firmly explain the discrepancies in her intake records. See id.

 

12 Two of Petitioner’s other fact witnesses (Mr. Rolando Chinea and Dr. Diane Moore) also attended this dinner. Tr. 

at 47. 
10

at 61, 88. She assumed that whoever provided her medical history to her ER treaters must have 

simply been describing “how [she] used to be” (presumably prior to her alleged onset of symptoms 

in November 2012), rather than providing a truthful assessment of the start of the severe symptoms 

in January. Id. at 88. 

B. Mr. Rolando Chinea

Petitioner’s second fact witness was her husband, Mr. Rolando Chinea. Tr. at 124-160. He 

also filed two witness declarations. See Ex. 56 & 67.13 Mr. Chinea is an electrical engineer. Tr. at 

124. He graduated from the University of Puerto Rico in 1979, and moved to the United States 

that same year to take a job with the Department of Defense. Id. at 125. Mr. Chinea met Petitioner 

in 1970, and they were married in 1976 (prior to their move). Id. at 125-26. In addition to his 

primary employment, Mr. Chinea assists Petitioner with her duties at Alma Joy Villa. Id. at 156-

57. In particular, he often handles evening or overnight responsibilities at the care facility given 

the workload and small staff. Id. at 157-58. 

Mr. Chinea described Petitioner as energetic, organized, and warm-hearted. Tr. at 127. 

Prior to receipt of the flu vaccine in October 2012, Mr. Chinea testified that Petitioner’s “energy 

level was very high.” Id. at 128 (“[s]he used to go walking, dancing, to the gym almost daily, and 

she was always like the [energizer] bunny rabbit, you know, going – moving and helping people 

and – all the time”). Petitioner’s typical day began around 5:00 AM (and included both a trip to 

church and the gym as well as assisting with breakfast and household tasks). Id. at 128-29. She 

would then go to work, where Mr. Chinea testified she was “more than active” and successfully 

managed both hospital duties and staff management. Id. at 129. 

Following vaccine administration, however, Mr. Chinea began to notice a change in 

Petitioner’s energy level starting in early November 2012. Tr. at 130, 143. She expressed feelings 

of cold, slept for long hours, and attended gym classes less often. Id. at 144. She also mentioned a 

“lack of sensation” in her hands, fingers, arms, and legs. Id. Petitioner’s already low energy level 

worsened that Thanksgiving, and resulted in her not participating in the holiday as she had in the 

past. Id. at 129-30, 132. She also began requesting assistance with various household tasks 

(including opening jars or lifting items to and from the stove). Id. at 130, 131 (“[s]he didn’t have 

the strength or the stamina to go [to the grocery store]”). These symptoms progressed through the 

Christmas holiday. Id. at 132-33. Petitioner also reported experiencing vision problems. Id. at 145 

(“I had to change the size of the font [on the computer] because she couldn’t read properly.”).

 

13 At hearing, Mr. Chinea acknowledged that Petitioner reviewed and edited his two witness statements. Tr. at 142-

43. He maintained, however, that any corrections she would have made were merely grammatical in nature. Id. at 143. 

He seemingly denied knowing if any such changes were made. Id.
11

Mr. Chinea also testified about Petitioner’s December 10, 2012, appointment with Dr. Lara. 

Tr. at 134. He maintained it was likely he had traveled with Petitioner to the appointment, but 

added that he was not present for any conversation between Dr. Lara and Petitioner regarding her 

purported symptoms at the time. Id. at 134-35, 136.

14 Mr. Chinea did, however, confirm that 

Petitioner likely would have taken medical notes along with her to discuss with Dr. Lara (as this 

was her typical practice). Id. at 135. Regarding the health agenda produced by Petitioner at hearing, 

Mr. Chinea acknowledged that Petitioner had only recently located it. Id. at 147-48. He also 

confirmed that it was common for her to prepare written notes about her health status and 

symptoms, and then later to transfer them to the home computer. Id. at 147. 

Upon Petitioner’s presentation to the emergency room on January 31, 2013, Mr. Chinea 

was the primary historian during the visit (as Petitioner was having difficulty talking and 

communicating to hospital personnel). Tr. at 137; see also Ex. 67 at 3. Mr. Chinea testified that he 

informed hospital personnel that Petitioner had received the flu vaccine that year. Tr. at 138-39. 

He also took copies of Petitioner’s medical records to the ER. Id. at 149. Mr. Chinea described 

Petitioner as in “really bad shape.” Id. at 137. She was “unbalanced” and could not walk unassisted. 

Id. Mr. Chinea also recalled some breathing troubles and voice hoarseness prior to Petitioner’s 

presentation. Id. at 137-38.

Mr. Chinea denied telling hospital personnel what the contemporaneous records indicate 

he said: that Petitioner had been in her “usual state of health” in the days prior to presentation (or 

before January 28th). Tr. at 138-39. He reported instead that her health had been in decline since 

November of that year, although she previously always had been a healthy person (and thus 

suggesting, as Mrs. Chinea did, that these record references inaccurately confused her prevaccination health with her symptoms in the weeks before hospitalization). Id. at 139, 140. Thus, 

Mr. Chinea disputed the accuracy of notations in the contemporaneous record that suggested that 

Petitioner had been exercising as normal before the ER visit. Compare Tr. at 139 (“[s]he went to 

the gym, did one hour samba and one hour walking in her neighborhood”) with 140 (“that 

statement there is not accurate”). Rather, such descriptions applied to Petitioner’s pre-vaccination 

circumstances, “not in January or in December of that year.” Id. at 140 (emphasis added).

 

14 There was some confusion at hearing regarding whether in fact Mr. Chinea took Petitioner to the December 10th

visit with Dr. Lara. On cross, Mr. Chinea acknowledged that it was possible that a friend had taken her to the 

appointment, and that he had transported her to a follow-up appointment thereafter. Tr. at 153-55. He later maintained 

that he had taken her to the December 10th appointment. Id. at 155-56. His witness statement, however, was somewhat 

unclear. The statement suggests that an unspecified friend took Petitioner to an appointment with Dr. Lara “in early 

December.” Ex. 56 at 7. That same statement noted that Mr. Chinea “had to drive her to other appointments at this 

time.” Id. at 7 (emphasis added).
12

In the same vein, Mr. Chinea sought to clarify some of his statements (contained in the 

contemporaneous medical record) regarding Petitioner’s cat allergy, and a particular reaction she 

may have experienced just before her hospitalization. Tr. at 140-41. Mr. Chinea recalled 

Petitioner’s visit to the home of a potential Alma Joy Villa client a few days prior to the ER 

presentation, at which time Petitioner experienced an adverse reaction to a cat inside the home. Id.

at 141. According to Mr. Chinea, Petitioner had something like an “asthma attack” accompanied 

by additional symptoms (including an inability to talk, walk, or sit down). Id. Given the emergent 

nature of Petitioner’s hospital presentation, Mr. Chinea informed treaters of the above-mentioned 

event due to its proximity in time to her hospitalization. Id. at 150-51. Notably, Mr. Chinea 

acknowledged that he did not also report Petitioner’s purported November/December symptoms 

to treaters at that time because he had not “connect[ed] the dots” between the flu vaccine and her 

downward progression at that point. Id. at 151. 

Following Petitioner’s ER visit, Mr. Chinea conducted his own research concerning 

Petitioner’s GBS diagnosis and whether the disease might be vaccine-related. Tr. at 159-60; Ex. 

56 at 5-6. At hearing, Mr. Chinea stated that he suspected the flu vaccine initially because 

Petitioner’s testing for traditional triggers revealed no explanation. Tr. at 159. Despite the above, 

Mr. Chinea confirmed that his research was prompted only by his desire to find a possible 

explanation for his wife’s symptoms. Id. He otherwise asserted that the research he individually 

performed occurred in the weeks following Petitioner’s hospital presentation, and he presented his 

concerns to Petitioner’s treaters thereafter. Id.

C. Dr. Arturo Sidransky

Petitioner’s next witness was Dr. Arturo Sidransky. He testified at hearing and offered 

witness declarations in support of Petitioner’s assertions concerning her overall health progression 

from November 2012 to her hospital presentation in January 2013. Tr. at 103-23; Ex. 57

(Declaration of Dr. Sidransky).

15

Dr. Sidransky is medical doctor with over forty years of practice experience. Tr. at 104. He 

graduated from the University of New Mexico Medical School and thereafter completed an

internship in obstetrics/gynecology and a fellowship in emergency medicine. Id. Dr. Sidransky 

first met Petitioner in 1979-80 while employed at St. John’s Regional Medical Center in Oxnard, 

California, when he attended to Petitioner’s daughter during an emergency room visit. Id. at 104-

05. The families thereafter became social friends. Id. During that time period, Petitioner worked 

 

15 At hearing, Dr. Sidransky acknowledged that Petitioner requested he author the above-mentioned declaration prior 

to her filing of this matter. Tr. at 114-15. He otherwise stated, however, that his declaration was solely his work (i.e.,

he did not use notes or explanations provided by Petitioner to aid him in writing drafts or the finalized version). Id. at 

115-16.
13

in the education department at St. John’s and Dr. Sidransky would participate in health programs

sponsored by Petitioner and other staff members. Id. at 105-06. Dr. Sidransky’s mother later 

became a resident of Alma Joy Villa. Id. at 106. Dr. Sidransky testified that he sees Petitioner on 

a weekly basis (or more often). Id. at 107. 

Prior to her hospitalization in January 2013, Petitioner was “vivacious” or the “life of the 

party.” Tr. at 109-10. It was for these reasons that Dr. Sidransky entrusted his mother’s care to 

Petitioner and her staff. Id. But (and in contrast to how she had typically acted at prior 

Thanksgivings), Petitioner was in his view noticeably different in November 2012. Id. at 107-08, 

111. Dr. Sidransky specifically recalled Petitioner stating she was “hurting” and had low energy 

and arm pain. Id. at 111; Ex. 57 at 4 (declaration regarding arm pain). Her voice was also “raspy 

and muffled.” Tr. at 111. On cross, Dr. Sidransky acknowledged that he did not really delve into 

the nature of Petitioner’s concerns at the time (i.e., he did not make recommendations for treatment 

or discuss the symptoms with her). Id. at 116. He also noted that at this time Petitioner appeared 

to have a normal appetite and gait. Id.

Dr. Sidransky next discussed two social outings during the month of December 2012, 

which in his view further evidenced Petitioner’s adverse symptoms. He recalled a holiday party at 

a Greek restaurant where families gathered for dancing. Tr. at 111-13. Petitioner, however, refused 

an invitation to the event due to low energy. Id. at 112. Dr. Sidransky also recalled his wife’s 

birthday party in mid-December 2012. Id. at 112-13. Petitioner attended this event, but would not

participate in activities due to an inability to concentrate and persistent low energy. Id. at 112 (“we 

played cards – but [Petitioner] didn’t feel that she had the energy or would be able to concentrate 

to play cards, so she refused to play with us”).

Dr. Sidransky also discussed Petitioner’s January 2013 hospital presentation and her 

symptomatology course leading up to the GBS diagnosis. At hearing, Dr. Sidransky testified that 

he examined Petitioner some time in the days prior to her hospital presentation (though, he could 

not identify the exact date). Tr. at 118. Petitioner’s husband had called him and asked that he visit 

Petitioner at home due to her various adverse symptoms (including tiredness, watery eyes, a 

muffled voice, a flushed face, and an inability to sit up or get out of bed). Id. at 119. Dr. Sidransky 

recalled that Petitioner did not complain of pain, and her physical exam was otherwise normal

apart from the above-noted complaints. Id. He did not test her reflexes at that time. Id. Dr. 

Sidransky recommended that Petitioner’s husband take her to the emergency room if her condition 

worsened. Id. He otherwise could not recall when Petitioner began to experience the symptoms 

noted above. 

Dr. Sidransky subsequently went to see Petitioner on January 31, 2013 (the day she 

presented to the hospital), and discussed her condition with hospital treaters. Tr. at 113. Dr. 
14

Sidransky recalled that Petitioner was intubated upon presentation, and had minimal movement in 

her hands and feet. Id. (“she couldn’t move a toe . . . [s]he couldn’t move a finger”). He also spoke 

with Petitioner’s intake neurologist at the time, who informed him that Petitioner likely had GBS 

secondary to the flu vaccination she received in October 2012. Id. at 114, 122; see also Ex. 57 at 

5. Later, however, Dr. Sidransky acknowledged he was unsure how he found out about Petitioner’s 

prior receipt of the flu vaccine (i.e., Petitioner or her husband may have told him at some point). 

Tr. at 120, 122-23. Dr. Sidransky’s declaration (filed as Ex. 57) stated that he actually informed 

Petitioner’s hospital treaters that she received the shot in October of the previous year. Ex. 57 at 5 

(“I related to them about her having the vaccine.”). He otherwise stated that he was not involved 

in Petitioner’s care during or after her GBS diagnosis. Tr. at 122. 

D. Ms. Enjoli Flores

Petitioner’s next fact witness was Ms. Enjoli Flores. She testified at hearing and offered 

witness declarations in support of Petitioner’s assertions regarding the onset of her symptoms. Tr. 

at 161-80; Ex. 66.

16

Ms. Flores moved to the United States in 2006 from Puerto Rico. Tr. at 161. She met 

Petitioner in July 2012 (roughly three months prior to her receipt of the flu vaccine) at a fitness 

club. Id. at 162. Ms. Flores recalled that she and Petitioner shared many common interests (such 

as attending dancing classes and religious services, and having lunch or dinner together). Id. at 

162-63. Ms. Flores testified that from July to October 2012, she routinely interacted with Petitioner 

three to four times per week. Id. at 164. She described Petitioner as full of energy. Id. at 163, 165-

66. In her view, Petitioner was always happy and active in managing her many responsibilities 

(including the family, gym, her job, and church). Id. at 165-66. 

Consistent with the fact testimony discussed earlier, Ms. Flores recalled that Mrs. Chinea

began to change around mid-November 2012. Tr. at 167-68. Ms. Flores spoke with Petitioner on 

the phone in early November 2012 to discuss holiday preparations, and she did not recall 

complaints of low energy around that time. Id. at 77. Thereafter, however, Petitioner began to 

exhibit exhaustion just prior to the Thanksgiving holiday. Id. at 168, 170. Ms. Flores recalled a 

specific instance at a fitness class where Petitioner complained of left arm pain and exited the class 

early. Id. at 169. Ms. Flores also discussed a time around November 20, 2012, when she kept 

Petitioner’s granddaughter while she attended a doctor’s appointment. Id. at 170, 177. Ms. Flores 

testified that Petitioner was experiencing voice hoarseness around the time of this appointment. Id.

 

16 On cross, Ms. Flores testified that she sent drafts of her declaration to Petitioner for her review. Tr. at 174-75. Ms. 

Flores recalled that Petitioner offered suggestions/edits regarding her recollection of Petitioner’s health in December 

2012 (specifically in the context of Petitioner’s refusal to attend Ms. Flores’s birthday party). Id. at 174. She did not 

remember if Petitioner offered suggestions regarding any other portion of her declaration. Id. at 175.
15

at 170. On cross, however, Ms. Flores could not recall if Petitioner complained of any other 

symptoms or what type of doctor she saw. Id. at 177. She remembered only that Petitioner wasn’t 

feeling well and that the symptoms had not resolved. Id. at 178.

For Thanksgiving that year, Petitioner had planned to host a meal at her home (and cook 

for a local homeless shelter), but the plans fell through due to her health. Tr. at 168. Ms. Flores 

recalled that she attended a Thanksgiving meal at the home of a different friend instead. Id. at 170-

71. During the meal, Ms. Flores described Petitioner as quiet and tired. Id. at 171 (“she wasn’t 

talking or being part as she was used to being, so quiet”). On cross, she also stated that Petitioner 

had trouble walking (i.e., she was walking “slowly”). Id. at 175. Ms. Flores did not recall, however, 

that Petitioner needed assistance serving her plate. Id.

The symptoms described above continued into December 2012. Tr. at 171-72. Ms. Flores 

recalled that Petitioner refused an invitation to her birthday party in mid-December due to sickness 

symptoms (including congestion and breathing troubles). Id. She also recalled a time in early 

January 2013, when Petitioner visited her home. Id. at 172. Ms. Flores was pregnant, and Petitioner 

was helping her prepare for the baby’s arrival. Id. At the visit, Ms. Flores recalled Petitioner 

looking tired and weak. Id. Petitioner also refused an offer to stay for lunch because she wanted to 

go home and rest. Id. On cross, Ms. Flores noted that she was not concerned about the January 

2013 symptoms because Petitioner told her she was not contagious. Id. at 176. She could not, 

however, offer details regarding any additional wellness appointments or other explanation for 

why Petitioner would know her symptoms were not concerning. Id.

E. Dr. Diane Moore

Petitioner’s final fact witness was Dr. Diane Moore. She testified at hearing and offered 

witness declarations detailing Petitioner’s adverse symptoms in the months leading up to her GBS 

diagnosis. Tr. at 180-207; Ex 55.

17

Dr. Moore is an English professor at Ventura Community College in Ventura, California. 

Tr. at 181. She became acquainted with Petitioner while searching for a residential care facility for 

her elderly mother. Id. at 182. Dr. Moore stated that she chose Petitioner’s facility for her mother 

due in part to Petitioner’s extensive background in senior living and her overall enthusiasm for the

work. Id. Dr. Moore’s mother has been a resident at Alma Joy Villa since May 2010. Id. Because 

of Petitioner’s extensive involvement in her mother’s daily care, Dr. Moore communicated with 

 

17 Dr. Moore testified that she wrote multiple drafts of her statement before the present matter was filed. Tr. at 200-

01. She denied, however, that her drafts were shared with Petitioner (or others), and maintained that she had no input 

from Petitioner or her family and friends. Id.
16

Petitioner (either telephonically or in-person) almost daily between May 2010 and October 2012. 

Id. at 183.18

Dr. Moore described Petitioner as “extremely energetic,” organized and involved in her 

community. Tr. at 186 (“[she] was a dynamo”), 187. Petitioner was dedicated to her work at Alma 

Joy Villa and would engage personally in the care of each resident. Id. at 187. She also encouraged 

family members to participate in residential activities. Id. By early November 2012, however,

Petitioner was not often at the facility when Dr. Moore visited, and voiced concerns regarding her 

health (including voice hoarseness, tiredness, and achiness) during their phone conversations. Id.

at 188, 203. Dr. Moore also recalled a time in mid-November of that year when Petitioner failed 

to show for a scheduled meeting regarding her mother’s care. Id. at 190. According to Dr. Moore, 

during a phone conversation thereafter, Petitioner explained that she was not feeling well and 

missed the meeting because she had fallen asleep. Id. at 191. Though Dr. Moore did not see 

Petitioner personally at this time, she recalled that Petitioner was still experiencing voice 

hoarseness and weakness. Id. At some point during their discussions in November 2012, Dr. Moore 

also testified that Petitioner complained of persistent swelling in her arm following a flu 

vaccination. Id. at 188.

Dr. Moore testified that Petitioner’s adverse symptoms continued into the Thanksgiving 

holiday. Tr. at 192. In prior years, Dr. Moore recalled, Thanksgiving at Alma Joy Villa was a 

“fiesta” with beautiful decorations and a complete Thanksgiving dinner. Id. at 187-88. Petitioner 

was “the life of the party” and created a celebratory environment for both residents and their 

families. Id. at 188. Thanksgiving 2012, however, was “dramatically different.” Id. at 192.

Petitioner ordered a precooked holiday dinner that year, and the facility was not decorated. Id. at 

192-93. Dr. Moore described Petitioner as “exhausted” and “quiet.” Id. at 193. Her eyes were 

“dull” and “lackluster.” Id. When asked about the above-mentioned behavior, Petitioner stated that 

she did not feel well. Id.

Thereafter, in December 2012, Dr. Moore expressed concerns regarding Petitioner’s health 

and its effect on her management of Alma Joy Villa (especially in the context of patient/caregiver 

communication). Tr. at 194. For example, Dr. Moore noticed that Petitioner was not at the facility 

as much when she visited her mother. Id. at 193-94. Dr. Moore scheduled a meeting with Petitioner 

to address these concerns. Id. at 194-95. During the meeting, Petitioner apologized and explained 

that she “wasn’t up to being there like she had before.” Id. at 195. Petitioner agreed to communicate 

more regularly by phone with caregivers and staff. Id.

 

18 To prepare for hearing, Dr. Moore relied in part on a detailed diary of calendars she kept regarding her mother’s 

care. These diaries included specific dates that she met with Petitioner and/or visited the Alma Joy Villa facility. Tr. 

at 184-86. 
17

Petitioner’s symptoms continued through the 2012 Christmas season. Tr. at 195. Like the 

Alma Joy Villa Thanksgiving celebration that year, the Christmas party was less festive than in 

prior years. Id. By this time, Petitioner had become more “lethargic” and “seemed weak.” Id. 

Following the Christmas party, Dr. Moore recalled a social outing with the Chineas in late 

December 2012. Id. at 196. Dr. Moore and her mother treated the Chineas to dinner at Outback 

Steakhouse to thank them for their hard work that year. Id. They also planned to attend a musical 

theater performance at the local college after dinner. Id. During the dinner, Dr. Moore recalled 

Petitioner was still experiencing voice hoarseness (and did not seem to be enjoying herself). Id. at 

196, 206. She also choked on her food. Id. at 196, 197 (“as we were eating, [Petitioner] started 

gasping for breath and choking . . . . [but] eventually breathed”).

Moving to early January 2013, Dr. Moore recalled an instance where Petitioner canceled a 

scheduled meeting. Tr. at 197. Dr. Moore had planned to discuss her mother’s medication, but 

Petitioner called to say she wasn’t feeling well. Id. (“she wasn’t up to coming to the facility, and . 

. . [h]er voice was much more hoarse and weak”). The two spoke by phone instead. Id. Dr. Moore 

next recalled Petitioner’s demeanor at her mother’s birthday party at Alma Joy Villa in midJanuary 2013. Id. at 197-98. According to Dr. Moore, Petitioner was not involved in the party 

planning (which was unusual) and arrived over one hour late because she had fallen asleep. Id. at 

198. Dr. Moore also described a book signing event she and Petitioner attended together. Id. at 

198-99. Dr. Moore had authored a book on the topic of senior assisted living, and she invited 

Petitioner to speak at the signing event. Id. at 198. During the event, Dr. Moore recalled that 

Petitioner could not complete her planned speech due to voice hoarseness. Id. at 199. She also 

lacked her usual “sparkle.” Id.

F. Additional Declarations

Besides the hearing testimony offered by the above-noted fact witnesses, Petitioner filed 

five declarations from other family members and professional/social acquaintances in attempts to 

bolster her claim that she was experiencing GBS-related symptoms beginning in November 2012. 

See Ex. 61 (Declaration of Tom Hovarth) (“Hovarth Dec.”); Ex. 62 (Declaration of Linda Neilson)

(“Neilson Dec.”); Ex. 63 (Declaration of Carmen Garay) (“Garay Dec.”); Ex. 64 (Declaration of 

Doris Calderon) (“Calderon Dec.”); Ex. 65 (Declaration of Astrid Carrillo) (“Carrillo Dec.”).

The statements provided by the above-named individuals are consistent with the fact 

witness testimony offered at hearing. In short, Petitioner was noted to have decreased energy 

during the early weeks of November 2012 (which continued thereafter through December of that 

year). Hovarth Dec. at 4; Neilson Dec. at 4; Garay Dec. at 4; Calderon Dec. at 4; Carrillo Dec. at 

5. Multiple statements also referenced additional adverse symptoms Petitioner experienced 

throughout those months, including: voice troubles, arm pain, fatigue, low stamina, shortness of 
18

breath, exhaustion, and loss of appetite. Hovarth Dec. at 4; Neilson Dec. at 4; Garay Dec. at 4; 

Calderon Dec. at 4; Carrillo Dec. at 6-7. Many expressed confusion as to what caused Petitioner’s

symptoms (as she had reported to them that she had not experienced any new onset health 

complications or altered her routine in any way). Hovarth Dec. at 4; Neilson Dec. at 4; Garay Dec. 

at 5.

One statement in particular (from Tom Hovarth) noted that Petitioner had expressed some 

concern that her flu vaccination might have precipitated her adverse symptoms. Hovarth Dec. at 

4. The statement also indicated that Mr. Hovarth was “against flu shots, pneumonia, etc., that 

government agencies perpetrate on us on a yearly basis.” Id. at 4. Mr. Hovarth’s statement did not 

indicate what prompted Petitioner to suspect the vaccine, however, or when these discussions 

occurred.

19 Mr. Hovarth did state that Petitioner was also against receiving the flu vaccine, but did 

so because it was required by the state of California given her occupation as a health facility 

administrator. Hovarth Dec. at 4. 

III. Expert Testimony

A. Petitioner’s Expert – Dr. Lawrence Steinman

Dr. Steinman prepared two written reports for this case and testified at hearing. Tr. at 213-

300, 355-62; Expert Report, dated Aug. 19, 2015 (ECF No. 31-1) (“First Steinman Rep”); Expert 

Report, dated Feb. 15, 2017 (ECF No. 64-1) (“Steinman Supp. Rep.”). He offered the opinion that 

the flu vaccine Petitioner received in late October 2012 was the cause of her GBS, and that the 

symptoms she experienced in November and December of 2012 were associated with her illness, 

even though her symptoms did not become acute until late January 2013 (almost three months 

after vaccine administration). Tr. at 218.

Dr. Steinman obtained his medical degree from Harvard Medical School, where he 

completed a fellowship in chemical neurobiology. Tr. at 214; see also CV, filed as Ex. 76 (ECF 

No. 74-1) (“Steinman CV”) at 1. After medical school, Dr. Steinman went on to complete both a 

pediatrics and neurology residency at Stanford University. Tr. at 214; Steinman CV at 1. He then 

joined the faculty at Stanford in 1980, where he presently serves as the George A. Zimmerman 

Professor of Neurological Sciences, Neurology, Genetics and Pediatrics. Tr. at 216; Steinman 

CV at 1. During his tenure, Dr. Steinman estimated that he has treated multiple patients with 

various diseases, including MS, GBS, and/or ADEM. Tr. at 215. Dr. Steinman has also published 

 

19 The declaration indicated that Mr. Hovarth noticed a change in Petitioner’s disposition “[i]n the beginning of 

November 2012, around the week of the 12th.” Hovarth Dec. at 4. Presumably his conversation with her happened 

around this time, although the declaration does not give a specific date. See id.
19

extensively in peer-reviewed journals on topics including neuroimmunology and GBS. Steinman 

CV at 5-46. He is an exceedingly qualified expert on the subjects at issue in this case, and has 

testified numerous times in the Vaccine Program.

To begin, Dr. Steinman reviewed Petitioner’s symptoms and the progression of her 

condition compared to the most common features of GBS. Tr. at 218-19. The relevant literature 

cited by Dr. Steinman describes GBS as an autoimmune disease in which the immune system 

essentially attacks components of the peripheral nerves, leading to acute (or rapidly progressive) 

flaccid symmetrical weakness of the limbs (including paresthesia and sometimes pain). See, e.g., 

J. Menze, et al., Textbook of Peripheral Neuropathy 167 (1st ed. 2012), filed as Ex. 80 (ECF No. 

74-5) (“Menze”) A typical course can also include generalized weakness, sensory disturbances 

(i.e., tingling), pain, unsteady gait, and loss of bowel function. Id. The disease is diagnosed using 

an array of diagnostic testing (including a physical exam, CSF analysis, nerve conduction studies, 

and MRI imaging). Id. at 168. The precise trigger of the disease is unknown, but it is thought to be

often precipitated by a respiratory or gastrointestinal infection. Id. at 167.

GBS has different variants. Dr. Steinman categorized Petitioner’s GBS as the Miller-Fisher 

variant (consistent with the medical record evidence filed in the case). Tr. at 218; First Steinman 

Rep. at 1.

20 A typical course associated with this variant can include eye movement abnormalities 

and ataxia (due to the involvement of the brainstem’s peripheral nerves), along with the other more 

traditional manifestations of GBS identified above. Tr. at 218, 239. Notably, the Miller-Fisher 

variant is also associated with a particular antiganglioside antibody: the GQ1B antibody. Id. at 

219-20. Dr. Steinman relied heavily on Petitioner’s medical record in confirming the above-noted 

GBS diagnosis. As those records revealed, Petitioner presented to the emergency room in late 

January 2013 with generalized weakness, muscle soreness, shortness of breath, and absent deep 

tendon reflexes (along with an associated cough/congestion and voice hoarseness). First Steinman 

Rep. at 4-5; Ex. 7 at 1-2. A lumbar puncture test conducted on February 1, 2013, supported the

GBS diagnosis. First Steinman Rep. at 5; Ex. 7 at 1. Petitioner also tested positive for the GQ1B 

antibody. Tr. at 219-20. 

Dr. Steinman next discussed Petitioner’s health history prior to her hospital presentation 

on January 31, 2013, and its purported relationship to her eventual diagnosis. In his view, Petitioner 

exhibited multiple GBS-related symptoms in the months prior to her hospitalization, beginning as 

 

20 In so opining, Dr. Steinman attempted to refute some suggestion by Dr. Donofrio (Respondent’s opining expert)

that Petitioner’s condition was best characterized as brainstem encephalitis. Tr. at 266-67, 297. He agreed that the 

medical record revealed some evidence that Petitioner had experienced “neuro-inflammation” or “inflammation in the 

brainstem,” but maintained the record best supported a diagnosis of GBS. Id. at 270. In any event, Dr. Donofrio 

accepted GBS to be the diagnosis best supported by the medical record at hearing. Id. at 307, 329.
20

early as Thanksgiving 2012 (including double vision, overwhelming fatigue, taste disturbance,21

voice hoarseness, feelings of tingling/cold, and swallowing difficulties). Tr. at 234-40. These 

symptoms, he asserted, were likely due to inflammation in the various nerves in and around the 

brainstem. Id. at 296.

In Dr. Steinman’s opinion, Petitioner’s “overwhelming fatigue” was likely due to 

inflammation occurring congruently with the underlying nerve damage initiated by the 

autoimmune process that ultimately resulted in a GBS diagnosis. Tr. at 236 (“if your nerves aren’t 

functioning well, doing the activities of daily living just takes so much more energy”). Voice 

hoarseness (as described by Petitioner and her fact witnesses), in his view, could also be caused 

by the “impact of inflammation” on nerves controlling the larynx and vocal cords. Id. at 240.

Similarly, tingling could be a consequence of inflammation in the peripheral nerve “between its 

root and the distal portion.” Id. Dr. Steinman opined that Petitioner’s swallowing problems were 

likely due to inflammation in the cranial nerve (although he allowed for the possibility that the 

fatigue or hoarseness she was experiencing could have played a role in the swallowing issues). Id.

at 241. Petitioner’s feelings of cold/chilliness, by contrast, were in Dr. Steinman’s experience

atypical of the GBS patients he has treated over the course of his career. Id. at 240-41. 

Nevertheless, he allowed for the possibility that cool feelings could be a result of underlying 

inflammation as well. Id. at 240. Dr. Steinman did not find it concerning that Petitioner had no 

associated fever around this time. Id. at 296. 

To support linking the fall 2012 symptoms to Petitioner’s later and more obvious GBS 

onset, Dr. Steinman cited various scientific articles detailing the common symptoms associated 

with a GBS course. See, e.g., A. Langmuir, et al., An Epidemiologic and Clinical Evaluation of 

Guillain-Barre Syndrome Reported in Association with the Administration of Swine Flu Influenza 

Vaccines, 119 Am. J. Epidemiology 841, 847-48 (1984), filed as Ex. 45 (ECF No. 32-8)

(“Langmuir”) (noting typical presenting clinical criteria for GBS can include progressive motor 

weakness, paralysis of the extremities plus trunk and/or cranial muscle involvement, bilateral

neurologic signs, lower motor neuron signs, areflexia, and autonomic dysfunction); L. 

Schonberger, et al., Guillain-Barré Syndrome Following Vaccination in the National Influenza 

Immunization Program, United States, 1976-1977, 110 Am. J. Epidemiology 105, 117 (1979), 

filed as Ex. 44 (ECF No. 32-7) (“Schonberger”) (respiratory impairment, trunk/cranial 

involvement, and sensory symptoms could also be associated with a GBS diagnosis). The abovementioned articles did not, however, offer the same level of specificity as Dr. Steinman’s opinion. 

 

21 Dr. Steinman did not reference any literature supporting his contention that taste disturbance was associated with 

GBS. Tr. at 236-37. He maintained, however, that the relevant scientific literature supports such a conclusion. Id.
21

Along the same lines, Dr. Steinman challenged Dr. Donofrio’s assertion that many of the 

above-mentioned symptoms (specifically, voice hoarseness, difficulty swallowing, double vision, 

or light sensitivity) were not common presenting indicia of GBS. Tr. at 277-78.22 Rather, he 

asserted (albeit in a conclusory manner) that his own “experience” as a practicing neurologist 

suggested that Petitioner’s persistence of symptoms was attributable to inflamed cranial nerves 

associated with her GBS course. Id. On cross, however, Dr. Steinman could not say what criteria 

he drew upon to characterize Petitioner’s overall constellation of symptoms as falling within GBS. 

Id. at 285. In addition, when confronted with certain GBS diagnostic criteria not evidenced in 

Petitioner’s history prior to her January 2013 hospital presentation (extremity paralysis, for 

example), Dr. Steinman seemingly categorized Petitioner’s case as an “exception” to the typical 

presentation, but offered no further explanation for the absence of certain normally-presenting 

criteria discussed in Schonberger/Langmuir (i.e., paresthesia/paralysis of the extremities, plus 

involvement of trunk/cranial muscle). Id. at 289-90. 

Dr. Steinman next proposed a mechanism by which the flu vaccine could have caused Mrs. 

Chinea’s GBS: the biologic process of molecular mimicry. Tr. at 230; First Steinman Rep. at 8-

14. His testimony on this point revolved around a concept that has been largely accepted in the 

medical community (and often in the Vaccine Program as well): that antibodies produced to fight 

off a foreign infectious antigen (or generated in response to a vaccine) can mistakenly attack, or 

cross-react with, myelin basic protein (“MBP”), a primary protein component of human nerves.

As a result, an autoimmune process begins, encouraging the production of antibodies that 

erroneously attack self-cells and structures, and thereby causing damage to the nerve’s myelin

sheath. Tr. at 219, 221-22; see also L. Steinman, Autoimmune Disease, Scientific American 107 

(1993), filed as Ex. 34 (ECF No. 31-4). Dr. Steinman’s expert report provided a highly detailed 

walkthrough of possible mimics between protein sequence components contained in the flu

vaccine and MBP. First Steinman Rep. at 8-14.

As an example of the molecular mimicry concept, Dr. Steinman briefly discussed the 

relationship between a particular bacterial infection and onset of GBS. Tr. at 224-26. All forms 

of GBS, Dr. Steinman testified, are autoimmune diseases occurring after the body mounts an 

immune response to a foreign agent that accidently targets the body's own nerve tissue. Id. at 222. 

One of the most well-known examples of molecular mimicry resulting in such an autoimmune 

process involves a structure shared between a bacterium called Campylobacter jejuni and 

gangliosides - sugar structures found on the surface of myelin. Id. at 224, 226. Dr. Steinman 

opined that it is medically accepted (while not fully understood) that certain vaccines can also 

 

22 For example, Dr. Donofrio suggested Petitioner’s swallowing problems could be evidence of GERD. Dr. Steinman 

did not find this assertion credible, given that Petitioner’s record evidenced a GERD diagnosis no earlier than April 

2015 (over two and one-half years post-vaccination). Tr. at 272. He otherwise attempted to recast the assertion by 

claiming that GBS is not associated with GERD. Id.
22

cause GBS, initiating an autoimmune process the same way microbe (like the Campylobacter

bacterium) might. Id. at 224. The components of the vaccine actually share molecular homologies 

with myelin structures present in the human body, and thus could produce the same reaction as a 

wild virus alone. Id. 

Dr. Steinman theorized that Petitioner’s GBS was likely initiated by the hemagglutinin 

component23 of the 2012 Fluvirin form of the flu vaccine. Tr. at 220, 223; First Steinman Rep. at 

11-12. He maintained that this component is known to trigger/induce antiganglioside antibodies, 

specifically the anti-GQ1B associated with the Miller-Fischer variant of GBS, via a crossreactivity response. Tr. at 220, 223, 225; First Steinman Rep. at 12; see I. Nachamkin, et al., AntiGanglioside Antibody Induction by Swine (A/NJ/1976/H1N1) and Other Influenza Vaccines: 

Insights into Vaccine-Associated Guillain-Barre Syndrome, 198 J. Infect. Disease 226 (2008), filed 

as Ex. 39 (ECF No. 32-2) (“Nachamkin”). In Nachamkin, researchers determined that the 

hemagglutinin component of the H1N1 vaccine had induced the production of anti-GQ1B

antibodies in mice, further supporting their overall conclusion that the H1N1 vaccine can induce 

GBS in this manner. Nachamkin at 226-27.

Given that Petitioner tested positive for the anti-GQ1B antibody and had received a flu 

vaccine containing hemagglutinin protein, Dr. Steinman found it reasonable to conclude that the 

H1N1 vaccine she received triggered her onset of related fatigue symptoms (and “somnolence” 

associated with an increase in anti-GQ1B). Tr. at 219-20; First Steinman Rep. at 13-14; see Y. 

Fukami, et al., Anti-GQ1B Antibody Syndrome: Antiganglioside Complex Reactivity Determines 

Clinical Spectrum, 23 Eur. J. Neuro. 320 (2016), filed as Ex. 41 (ECF No. 32-4) (confirming that 

elevated levels of anti-GQ1B antibodies can result in ataxia, neck/arm/leg weakness, and 

hypersomnolence). According to Dr. Steinman, antiganglioside antibodies can mount in a 

timeframe of days (typically seven to ten), and can thereafter exist in the body for months 

following production. Tr. at 356. 

Apart from the above, Dr. Steinman otherwise asserted that various treater statements 

contained in Petitioner’s records confirmed his suspicion that her receipt of the flu vaccine had 

precipitated GBS. Tr. at 227-28, 233. Dr. Neira (Petitioner’s primary care provider), for example, 

speculated that Petitioner’s GBS was vaccine-induced. Id. at 227 (citing Ex. 1 at 7, 73, 77). Dr. 

Steinman acknowledged that treater statements are not direct proof that a flu vaccine can cause 

GBS, but he nonetheless felt such statements “carrie[d] a lot of weight” in formulating an opinion 

by the Program’s preponderant standard. Id. at 228. He also cited to the flu vaccine package insert 

as supportive of an association between the vaccine and GBS. Id. at 227. 

 

23 At hearing, Dr. Steinman categorized this component as H1N1 California 2009. Tr. at 220. He defined 

hemagglutinin is the “outer coat” of the influenza virus. Id. at 228. 
23

Dr. Steinman next proposed a medically reasonable timeframe for a flu vaccine-induced 

GBS injury. In his view, the relevant scientific literature supported an onset as reasonably 

occurring within a period of a few weeks to up to three months post-vaccination. Tr. at 295 (“four 

months is too long . . . [but] three months I’d say is ok”).24 In support, he cited to Schonberger and 

Langmuir. Id. at 244-45; see Schonberger at 105 (five- to ten-week onset is medically appropriate); 

Langmuir at 841 (elaborating on Schonberger and determining that a six- to eight-week onset is 

more typical). In his view, however, the above timeframes are not absolute, but rather provide only 

a “useful yardstick” in estimating the typical progression of a vaccine-induced injury. Tr. at 246-

47, 257. Since researchers in Schonberger/Langmuir studied the 1976 swine flu vaccine 

specifically, Dr. Steinman felt it would be inappropriate to discount a longer onset for the version 

of the vaccine administered today. Id. at 247, 257.

Besides such admittedly older literature, Dr. Steinman also referenced a more recent article 

that he had co-authored. Tr. at 221-22; see S. Ahmed, et al., Antibodies to Influenza Nucleoprotein 

Cross-React with Human Hypocretin Receptor 2, 7 Sci. Transl. Med. 1 (2015), filed as Ex. 33 

(ECF No. 31-3) (“Ahmed”). Ahmed researchers conducted a study which established that the 

Pandemrix version of the flu vaccine (administered solely in Europe) contained high amounts of a 

nucleoprotein component associated with narcolepsy, causing that condition by interfering with 

certain hypocretin receptors in the brain. Tr. at 222; First Steinman Rep. at 8-10; Ahmed at 1. 

Although Petitioner’s injury is wholly different in this case, Dr. Steinman nevertheless maintained 

that Ahmed supported his timeframe argument, since Fluvirin, like Pandemrix, is an H1N1 

vaccine. Tr. at 246. The Ahmed study also catalogued various dates for onset of narcolepsy 

following flu vaccine administration, observing that it could present within up to six (or even eight)

months thereafter. Id. In Dr. Steinman’s view, Ahmed supported his contention that GBS could 

also present months following receipt of the flu vaccine. He later acknowledged, however, that 

Ahmed involved a distinguishable injury (narcolepsy) and a formulation of the flu vaccine “never 

used in the United States,” since Pandemrix is adjuvanted (whereas U.S. versions of the flu vaccine 

are not). Tr. at 246.25

 

24 On redirect, however, Dr. Steinman contradicted the above statements and suggested that he could offer an opinion 

regarding onset even longer than three months based on the concept that the relevant autoantibodies remain in the 

body (at detectable levels) for extended periods of time. Tr. at 361. 

25 In two other Program decisions involving narcolepsy, I have determined that Ahmed does not by itself support the 

contention that non-adjuvanted forms of the flu vaccine (meaning essentially all forms administered in the United 

States) can cause narcolepsy. See, e.g., McCollum v. Sec’y of Health & Human Servs., No. 14-790V, 2017 WL 

5386613 (Fed. Cl. Spec. Mstr. Sept. 15, 2017), motion for review den’d, 135 Fed. Cl. 735 (2017), aff’d, No. 14-790V 

(Fed. Cir. Feb. 25, 2019); D’Toile v. Sec’y of Health & Human Servs., No. 15-085V, 2016 WL 7664475 (Fed. Cl. 

Spec. Mstr. Nov. 26, 2016), mot. for review den’d, 132 Fed. Cl. 421 (2017), aff’d, 726 F. App’x 809 (Fed. Cir. 2018).
24

With regard to onset in the present matter, Dr. Steinman proposed that Petitioner’s GBSrelated symptoms began just before Thanksgiving 2012 (or close-in-time to November 22, 2012). 

Tr. at 243. Based on the literature discussed above, he opined that an onset around Thanksgiving 

2012 placed Petitioner’s symptomatology course (from vaccination, to first indicator of GBS, to 

nadir) well within the ten-week timeframe established in Schonberger. Id. at 248. Dr. Steinman 

relied primarily on the fact witness testimony (discussed above) in formulating his opinion, given 

the lack of confirming contemporaneous medical record evidence.26 He further asserted that he 

would allow for the possibility that her symptoms began earlier in November 2012 based on the 

statements offered by Petitioner’s friends and family (which in the aggregate support this earlier 

onset). Id. at 254 (“I could go before, but I’ll clearly say at Thanksgiving . . . .”).

At hearing, Dr. Steinman admitted that the long gap between Petitioner’s receipt of the flu 

vaccine and her hospital presentation in January 2013 was atypical for a vaccine-induced GBS 

injury. Tr. at 232 (“[H]ow can something linger from October 31st to January 31st[?]”). Rather, the

typical GBS disease course (which is well understood to be an acute process)27 lasts two to four 

weeks from onset to nadir. Id. at 283. This did not, however, alter his opinions concerning 

causation in the present matter. Id. at 284. Considering Petitioner’s overall course, Dr. Steinman 

opined that Petitioner’s GBS was likely subacute and/or “smoldered” for weeks (or in Petitioner’s 

case, over two months) prior to the time it became acute enough to compel her to seek emergency 

treatment. Id. at 251 (“the destructive pathology of [GBS] is gradual . . . [n]ot everything is there 

when the diagnosis is first made”), 252 (“some patients have clinical features and disease course 

similar to GBS except for a slower progression, that is, the progression that lasts longer than four 

weeks”), 291 (suggesting Petitioner’s symptoms were “subacute rather than subclinical”). Thus, 

Dr. Steinman concluded that Petitioner’s symptom onset (beginning in November 2012) gradually 

progressed into a more severe course (and eventual diagnosis) the following January 2013. Id. at 

252. 

To support his contention that a smoldering form of GBS is medically recognized, Dr. 

Steinman referenced a single article. J. Wanschitz, et al., Distinct Time Pattern of Complement 

Activation and Cytotoxic T Cell Response in Guillain-Barré Syndrome, 126 Brain 2034 (2003), 

filed as Ex. 69 (ECF No. 64-2) (“Wanschitz”). Wanschitz examined autopsy tissues of eleven

subjects (compared to four controls) who died within one day to eight weeks of GBS onset in order 

 

26 At hearing, Dr. Steinman assumed that Petitioner did not seek treatment for her symptoms in the intervening months 

(i.e., between November 2012 and January 2013) because she worked in a healthcare-centric field, and therefore 

disregarded the severity of the symptoms she was experiencing. Tr. at 238 (“health professionals make the worst 

patients”).

27 Dr. Steinman expressly acknowledged that the “textbook” definition of GBS suggests the disease is acute in nature. 

Tr. at 253. 
25

to determine if various immunological and cellular markers (i.e., T cells/proteins/antigens) present 

in the stages of demyelinating activity worsened or prolonged disease duration. Id. at 2034-38.

Significantly, Wanschitz defined the GBS disease course as “acute” if the patient died within four 

weeks of identified onset, or “subacute” if the patient died four to eight weeks following onset. Id.

at 2035. Hence, Wanschitz did not measure the period from the antecedent event speculated to 

have caused the GBS and onset – precisely the issue in this case. Id. (Table 1). Wanschitz 

concluded that damaging humoral immune responses (meaning largely antibody-mediated 

adaptive immune responses) predominated in the “early” stages of GBS (i.e., after recognized 

onset), whereas cellular immune response (T-cells as part of an adaptive response) occurred later, 

thereby suggesting that different therapeutic approaches would be more effective depending upon 

the temporal status of the patient’s disease. Id. at 2040.

Dr. Steinman proposed that Wanschitz suggested that the “destructive pathology” of GBS 

is gradual (given that killer T cells require a four-week incubation period prior to being detectable

in the body), and thus could take a course consistent with what Petitioner experienced. Tr. at 251-

52, 298-99.

28 On cross, however, Dr. Steinman acknowledged that Wanschitz focused primarily 

on the timeframe surrounding myelin destruction within the context of an existing case of GBS –

not the overall timing or progression of GBS symptoms measured from its origin (whether due to 

wild infection or otherwise). Id. at 282. 

Dr. Steinman also referenced a GBS textbook excerpt29 in support of his contention that 

GBS could be subacute and/or smolder for weeks before reaching nadir. Tr. at 252 (“progression 

[of GBS can] last[] longer than four weeks”); but see Menze at 167, 179-80. In his view, Menze

suggested that once a diagnosis of GBS is made, it could “progress[] for more than four weeks 

until it really bottoms out.” Id. Notably, however, the text referenced by Dr. Steinman applies only 

to the course of GBS following its onset (which in this case would mean that Petitioner’s nadir 

should have been reached by the end of December at the latest – a month before Petitioner sought 

emergency treatment). Menze at 167 (“current diagnostic criteria include <4 weeks of progression 

to clinical nadir”). Overall, Menze describes GBS as an “acute-onset, monophasic” disorder 

beginning “abruptly with relatively symmetrical onset of paresthesia and sometimes pain.” Id. 

Dr. Steinman further sought to rebut the evidence in Petitioner’s medical records 

suggesting that she may have experienced some preexisting viral infection (or respiratory tract) 

close-in-time to her onset of GBS. Tr. at 224, 231-32, 356, 359-60. Based on his review of the 

medical record, Dr. Steinman could not identify a firm viral diagnosis associated with GBS in the 

 

28 Dr. Steinman also asserted, correctly, that Dr. Donofrio did not contest Wanschitz’s literal findings (although Dr. 

Donofrio did dispute that Wanschitz supports Petitioner’s claim otherwise). Tr. at 255-56, 298-99. 

29 Respondent’s opining expert in this case (Dr. Donofrio) is the editor of the textbook. 
26

antecedent period prior to onset. Id. at 231. A flu (A/B) viral panel completed during Petitioner’s

hospital stay was negative. Id. at 260 (citing Ex. 7 at 4-5). Petitioner’s bacterial panel also revealed 

no concerning results. Id. at 287. He did agree, however, that certain “heavy hitter” viruses (i.e.,

Epstein Barr or CMV) were not tested for or eliminated as triggers. Id. at 263. Dr. Steinman 

otherwise asserted there was not strong (or confirming) evidence of a pre-onset URI. Id. at 232. 

Given the above, Dr. Steinman concluded that the flu vaccine was the more likely trigger 

of Petitioner’s GBS in the absence of evidence suggesting the presence of a firm alternative 

explanation. Tr. at 232, 359. On cross, he nevertheless acknowledged that in most cases of viralinduced GBS, the actual precipitating virus is not known, and that GBS is usually deemed 

idiopathic in nature. Id. at 260, 287 (“we really don’t know what causes your [GBS] in most 

cases”), 291. Even so, Dr. Steinman opined that he would still be reluctant to attribute Petitioner’s 

GBS to an antecedent viral infection even if she had not received a flu vaccination within the 

preceding months. Id. at 285-87. At the same time, he acknowledged that he would at least consider

any pre-existing viral symptoms in combination with the overall medical record when attempting 

to identify the most appropriate trigger. Id. at 286.

Occasionally during his testimony, Dr. Steinman stepped out of his role as 

medical/scientific expert and into the shoes of judicial “color commentator,” expressing views 

about the proper apportionment of legal burdens and standards applicable in the Vaccine Program, 

or making asides about his responsibilities as an expert based upon his understanding of the 

applicable legal standards. See, e.g., Tr. at 217, 234, 265-66 (suggesting that he could “probably 

structure a theory” identifying the vaccine as a substantial factor even if another cause were 

identified), 285, 287-88 (suggesting the method by which he would diagnose the cause of GBS “in 

the real world” is different from the context of a Vaccine Program case, where he is tasked by 

petitioners to propose a vaccine cause). 

B. Respondent’s Expert – Dr. Peter Donofrio

Dr. Donofrio, a neurologist, was Respondent’s expert. Tr. at 300-55. He filed two expert 

reports in support of Respondent’s position. See Expert Report, dated Nov. 30, 2015, filed as Ex. 

A (ECF No. 42-1) (“Donofrio Rep.”); Expert Report, dated Apr. 21, 2017, filed as Ex. F (ECF No. 

65-1) (“Donofrio Supp. Rep.”). In his view, the flu vaccine Petitioner received in October 2012

did not precipitate her GBS. Tr. at 306-07. Rather, Dr. Donofrio attributed her condition to a preexisting URI (and/or a combination of a URI and asthma attack caused by a cat allergy) close-intime to her January 2013 diagnosis. Id. at 323; see Donofrio Rep. at 6-9; Donofrio Supp. Rep. at 

6-7.
27

Dr. Donofrio is a professor of neurology and director of the MDA and ALS clinics at the 

Vanderbilt University Medical Center. Tr. at 301. He received his B.S. at the University of Notre 

Dame, and then attended the Ohio State University School of Medicine for his M.D. Id. He is 

board certified in neurology, internal medicine, electrodiagnostic medicine, and neuromuscular 

disorders. CV, filed as Ex. B (ECF No. 42-2) (“Donofrio CV”) at 2. Dr. Donofrio is experienced 

in treating peripheral neuropathies like GBS and CIDP, and is a member of organizations focusing 

on these kinds of neuropathic conditions. Tr. at 301-02; Donofrio Rep. at 1. Among his 

publications is a textbook on the specific topic of peripheral neuropathy. Donofrio CV at 21. He 

has also co-authored peer-reviewed papers on topics related to GBS. Tr. at 302. Dr. Donofrio 

testified that he diagnoses patients with various forms of peripheral neuropathy on a daily basis. 

Id. at 353. Specifically, Dr. Donofrio estimated that he treats around three GBS patients per month. 

Id. He is not an immunologist, however, and does not otherwise appear to have specific expertise 

in that field. 

Dr. Donofrio began by discussing the classical GBS symptomatology course. He defined 

GBS as a subacute “inflammatory autoimmune disorder of the peripheral nervous system” 

affecting both the motor and sensory autonomic nerve fibers. Tr. at 303, 305. GBS can be 

idiopathic, but “follows a viral infection or a presumed viral infection of the upper respiratory tract 

or in the GI system” roughly seventy percent of the time. Id. at 303. Dr. Donofrio explained that a 

typical GBS symptomatology course evolves “fairly rapidly” (i.e., over several days) with 

numbness/tingling in the feet and toes, which gradually ascends the legs and eventually the arms,

hands, and fingers. Id. at 304, 311-12. Weakness in the upper and lower extremities, pain in the 

lower back (or posterior thighs), areflexia (absent reflexes) and unsteady gait are also common

criteria for a GBS diagnosis. Id. at 304-05, 311-12. In his view, generalized fatigue is not a preacute presenting symptom of GBS, but could be a resulting symptom following a “full-blown”

course. Id. at 312. Ninety percent of GBS patients reach nadir of their illness between two and 

four weeks following onset, with a plateauing of symptoms thereafter. Id. at 304. After treatment, 

the majority of patients reach a full recovery (with only fifteen percent experiencing significant 

deficits). Id. 

Based on his review of Petitioner’s medical record, Dr. Donofrio agreed that hospital 

treaters properly diagnosed her with some form of “explosive” GBS (given her presenting 

symptoms documented in the contemporaneous record). Tr. at 307, 329 (“I think the 

preponderance of the clinical evidence and laboratory evidence pointed to [GBS] with some ocular 

involvement”); Donofrio Supp. Rep. at 3, 5; Donofrio Rep. at 6. Consistent with Dr. Steinman, Dr. 

Donofrio acknowledged that Petitioner’s GBS could be classified as the Miller-Fisher variant or

“Miller-Fisher-plus syndrome.” Tr. at 306, 330.

30 In addition to the classic GBS symptoms, the 

 

30 Dr. Donofrio’s first expert report suggested that Petitioner’s GBS included some atypical features, including 

hyperreflexia and a normal EMG and nerve conduction study. Donofrio Rep. at 6. He suggested that these variants 
28

Miller-Fisher variant typically presents with a “triad” of cranial nerve abnormalities (including eye 

movement weakness, areflexia in the arms and legs, and ataxia, usually of walking) after onset of 

the more typical peripheral nerve involvement. Id. at 306, 317; Donofrio Rep. at 5. Miller-Fisherplus, in his view, encompasses the triad discussed above, but can also implicate other cranial nerves 

(for example, those responsible for proper vocal control). Tr. at 330. 

However, and relying on his understanding that a classical GBS course spans a two- to 

four-week period, Dr. Donofrio vehemently disputed Dr. Steinman’s assertion that Petitioner’s 

GBS “lurked” for months before reaching nadir. Tr. at 316 (“[eleven] weeks would be a stretch for 

me to accept”), 353-55. In his view, Dr. Steinman’s opinion regarding Petitioner’s GBS course 

was inconsistent with what is known in the medical/scientific community about the disease’s 

progression (from onset to nadir). Dr. Donofrio opined that a similar disease course occurring over

a timeframe longer than four weeks would likely evidence an illness more along the lines of 

CIDP31 or SIDP32– peripheral neuropathies distinguishable from that which Petitioner experienced

(and diagnoses she never received). Id. at 306.

In challenging Petitioner’s contentions that GBS could take a longer course than is 

commonly understood, Dr. Donofrio took direct issue with the Wanschitz post-GBS autopsy study. 

Tr. at 318-20. Although he did not question the reliability of its specific findings, Dr. Donofrio 

proposed that Wanschitz was generally unhelpful in predicting the timeframe of a GBS disease 

course because it did not address “pre-onset” features of GBS relevant under Petitioner’s theory, 

 

might suggest that Petitioner was suffering from brainstem encephalitis rather than GBS. Id. But it appears that Dr. 

Donofrio conceded this point at hearing. His supplemental expert report also states an affirmed opinion that Petitioner 

was properly diagnosed with GBS. Donofrio Supp. Rep. at 3. But this concession did not detract from the thrust of 

Dr. Donofrio’s opinion (considering the strong evidence suggesting Petitioner’s alleged injury did not manifest in an 

acceptable timeframe). 

31 CIDP, or “chronic inflammatory demyelinating polyneuropathy,” is defined as a “slowly progressive, autoimmune” 

type of polyneuropathy, characterized by progressive weakness and impaired sensory function in the limbs and 

enlargement of the peripheral nerves. See Dorland’s Illustrated Medical Dictionary 361, 1491 (32nd ed. 2012). 

Although Dr. Donofrio acknowledged that GBS and CIDP can manifest similar symptoms, he maintained that CIDP 

should not be considered “chronic” GBS. Tr. at 348. Rather, in his view, the two are different illnesses (as evidenced 

by the accepted treatment protocol for each). Id. at 348-49. I have previously also found this to be an accurate 

characterization of the difference between GBS and CIDP. See, e.g., Strong v. Sec’y of Health & Human Servs., No. 

15-1108V, 2018 WL 1125666 (Fed. Cl. Spec. Mstr. Jan. 12, 2018). 

32 Dr. Donofrio testified that SIDP (or “subacute inflammatory demyelinating polyneuropathy”) is like GBS, but 

patients with this condition typically experience nadir around eight weeks (i.e., too long to be characterized as GBS, 

but too short to be CIDP). Tr. at 320-21. In Dr. Donofrio’s view, the condition is rare (and not well-accepted given 

the more modern diagnoses), as most polyneuropathy patients tend to fall in the GBS/CIDP categories. Id. at 321,

347-48. It is included in textbooks for inclusivity and historical significance. Id. at 347. Dr. Donofrio explained that 

Petitioner’s course was not consistent with an SIDP diagnosis (even if the alleged November 2012 onset were 

accepted) given its eleven-week progression. Id. at 321.
29

discussing instead the progression of the disease following its recognized acute onset. Id. at 318. 

Wanschitz thus did not stand for the proposition that GBS could smolder gradually for weeks prior 

to its acute presentation. Id. The article also did not set forth its subject inclusion criteria (or 

identify any variance in treatments received or additional diagnoses considered) – which caused 

Dr. Donofrio to question whether its subjects were indeed properly classified as GBS patients, or 

whether their deaths were even attributable to GBS (something a chart in Wanschitz suggests was 

not the case). Id. at 319-20; see Wanschitz at 2035 (Table I).

Dr. Donofrio spent some time at hearing discussing Petitioner’s symptoms during the 

months prior to her ER visit and subsequent hospitalization. Petitioner’s medical records revealed

multiple past illnesses (for example, depression and shingles) and pre-existing symptoms (such as 

blurred vision, incontinence, stress, and impaired hearing), all which caused Dr. Donofrio to 

question if her immediate post-vaccination symptoms could really be attributed to the flu vaccine, 

rather than reflecting a continuation of what she previously experienced before vaccination. Tr. at 

308-09; Donofrio Rep. at 6-7; Donofrio Supp. Rep. at 4.

In addition, and relying on witness testimony as well as alleged contemporaneous 

documentation of Petitioner’s fall 2012 symptoms,33 Dr. Donofrio questioned whether any of those 

symptoms had any connection to her subsequently-diagnosed GBS. Those symptoms (which 

included vaginal bleeding, feelings of tiredness34/exhaustion/cold, black/blue coloring on arms,

arm/chest/neck pain, sensitivity to touch, lack of appetite, and crying episodes) did not fit with the 

accepted GBS clinical criteria. Tr. at 311 (“[s]o when I look at this constellation of symptoms here, 

I would not be thinking of [GBS]”); see also S. Vucic, et al., Guillain-Barre Syndrome: An Update, 

16 J. Clin. Neuroscience 733, 734 (2009), filed as Ex. C (ECF No. 43-3) (noting that the dominant 

clinical feature of GBS is “generalized muscle weakness with sensory symptoms . . . ascending 

from the lower to upper limbs” which “reaches nadir at 2 weeks to 4 weeks after symptom onset”)

(emphasis added)). The typical, presenting clinical manifestations of GBS (i.e., ascending 

numbness/tingling, weakness, low back pain, and unsteady gait) were not described by Petitioner 

(or noted by Dr. Lara) in November or December 2012, making it unlikely that these earlier-intime symptoms could be related to a GBS course that became fulminant only in late January 2013. 

Tr. at 311-12; Donofrio Rep. at 6. He otherwise noted that Dr. Lara’s contemporaneous visit notes 

did not corroborate Petitioner’s claims that she was also experiencing other symptoms at this time 

 

33 Dr. Donofrio specifically relied on the medical visit notes from Petitioner’s OB/GYN, Dr. Lara (along with 

Petitioner’s self-documented health agenda) given the absence of any other contemporaneous appointment notes. Tr. 

at 309-11; Donofrio Rep. at 6.

34 Dr. Donofrio observed that Petitioner’s pre-vaccination health records indicated she was diagnosed with sleep apnea 

(both obstructive and central) in the years prior. Tr. at 311. In his view, this could better explain any specificallyclaimed symptoms of tiredness or sleepiness. Id. 
30

(including fatigue and voice hoarseness). Tr. at 309, 312. He could locate no other primary care 

physician or other specialist’s notes confirming the worsening of her condition around this time. 

Donofrio Rep. at 6. 

Dr. Donofrio acknowledged that Petitioner’s newly-discovered health agenda/diary (as 

confirmed by fact witness testimony) evidenced some concerning complaints in these earlier 

months that could be deemed symptoms secondarily associated with GBS (including fatigue, voice 

hoarseness, and arm/chest pain), but did not constitute presenting symptoms of the disease. He 

also disputed any contention by Dr. Steinman that Petitioner’s general feelings of fatigue in late 

November or December 2012 could constitute a presenting GBS symptom. Tr. at 331 (as an “initial 

symptom, I’ve never seen it”), 352.

35 Similarly, Dr. Donofrio opined that voice hoarseness is not 

a presenting feature of GBS. Id. at 314. He agreed that a raspy voice could reflect cranial 

involvement in the setting of a classic GBS course (i.e., congruent with limb weakness, 

hyporeflexia, sensory loss, etc.), but would not be evidence of early manifestation. Id. The bilateral 

arm pain Petitioner reported would also be atypical as a presenting symptom of GBS because GBS 

pain more commonly affects the lower back/thighs, not the upper extremities. Id. at 310-11, 344.36

Based on the above, Dr. Donofrio concluded that Petitioner’s onset of GBS likely occurred 

closer-in-time to her hospital presentation in late January 2013 (roughly three months postvaccination), thus falling outside the recognized, medically appropriate timeframe for a vaccineinduced GBS injury. Tr. at 322-33, 334; Donofrio Rep. at 8; Donofrio Supp. Rep. at 3. In his view, 

a three-month-long gap between receipt of vaccination and onset of symptoms was simply too 

long to reliably support causation. Tr. at 323. For support, he referenced two papers offered by

Petitioner (Langmuir and Schonberger), which suggested a five- to ten-week period would be an 

appropriate measurement. Id. at 322-23. Dr. Donofrio otherwise asserted that such a long onset 

runs counter to accepted immunologic principles (on which Dr. Steinman relies) as they relate to 

onset of neuromuscular disease. Considering the immune system will generally mount an antibody 

response to a foreign antigen (in Petitioner’s case, the anti-GQ1B) within a seven- to ten-day 

timeframe after infection or other insult, it would be unlikely that a vaccine (administered three

months earlier) caused the production of antibodies that could have triggered an acute response so 

 

35 On cross, Dr. Donofrio was questioned regarding fatigue as a presenting GBS symptom in the context of an EBVinduced GBS injury. Tr. at 332-33. He persuasively reaffirmed, however, that while fatigue could be an associated 

symptom (i.e., in the context of other typical GBS symptoms), it would not constitute a presenting symptom. Id.

36 During his direct testimony, Dr. Donofrio pointed out that Petitioner’s personal health agenda and Dr. Lara’s revised 

visit notes from 2014 both evidenced a bullet point list of similarly worded complaints (presumably to offer some 

suggestion that the revised notes were not wholly Dr. Lara’s own recollection of the events). Tr. at 312. Regardless of 

her documentation (or lack thereof), Dr. Donofrio maintained, as noted above, that many of the symptoms Petitioner 

allegedly complained of at this time were not related to GBS. Id. In any event, Dr. Lara was not qualified to opine as 

to such a diagnosis. Id.
31

much later. Id. at 346. Even assuming, hypothetically, Petitioner’s symptoms started around 

ten/eleven weeks following administration (as Dr. Steinman proposes), Dr. Donofrio opined that 

such a timeframe too fell outside the more accepted period (i.e., seven to eight weeks) referenced 

in Langmuir. Id. at 323.

As noted earlier, Dr. Donofrio identified a possible alternative cause for Petitioner’s GBS: 

a pre-onset URI. Tr. at 315, 345; Donofrio Rep. at 8. Upon reviewing Petitioner’s records from 

her January 2013 hospitalization, Dr. Donofrio referenced documented concerns by at least two 

treaters of a prior upper respiratory tract infection (congruent with or exacerbated by an asthma 

attack)37 in the two weeks immediately prior to presentation. Id. at 315 (citing Ex. 7 at 4-5). A

prior infection would better align with what is known about GBS (and better explain the eventual 

evolution of Petitioner’s symptoms). Donofrio Rep. at 8 (“[i]t is well-known that [GBS] is often 

preceded by an upper or lower . . . respiratory tract infection or gastroenteritis in approximately 

60-70% of patients”). Dr. Donofrio could not identify what virus caused the URI, and 

acknowledged that viral testing had not pointed to any possible such explanation. Tr. at 315. Even 

so, Dr. Donofrio noted that other radiologic evidence taken during Petitioner’s hospitalization was 

supportive of this point. Id. Petitioner’s CT scan, for example, revealed a bronchial obstruction 

and associated secretions, which confirmed his suspicion. Id. at 315-16. 

Dr. Donofrio did not spend much time at hearing addressing Petitioner’s proffered medical 

theory. Overall, he agreed that molecular mimicry is an acceptable biologic theory to explain how 

an autoimmune disease process could result from a viral trigger. Donofrio Rep. at 8. He seemingly 

also allowed for an association between GBS and receipt of the flu vaccine based on the 

Schonberger swine flu study. Tr. at 325, 331 (“I certainly think that theoretically [vaccines] can 

[cause GBS]”), 337-38; see also Schonberger at 117. Dr. Donofrio’s written report similarly 

affirms this point. Donofrio Rep. at 7. 

IV. Dr. Lara Fact Dispute

Before this matter was reassigned to me, the parties engaged in some discovery relating to 

the accuracy of the December 2012 medical record memorializing Petitioner’s visit with Dr. Lara. 

Although (as discussed below) the outcome of this discovery does not ultimately impact my 

resolution of the case, I nevertheless shall briefly summarize the procedural history relevant to 

Petitioner’s efforts to correct alleged inaccuracies in this medical record.

On November 7, 2014 (over two years following the above-mentioned visit – but prior to 

this case’s filing in January 2015), Dr. Lara authored a letter on Petitioner’s behalf seeking to 

 

37 Asthma alone, in his view, could not precipitate GBS. Tr. at 345-46. 
32

elaborate on what had been discussed at the December 2012 visit. Ex. 59 at 1-2. In it, Dr. Lara 

stated that in 2012 Petitioner had reported “significant loss of energy on a daily basis,” voice 

hoarseness (unrelated to allergies), throat swelling and difficulty with swallowing, numbness of 

the extremities and sensitivity to cold, weakness in her wrists and arms, and “sensitivity” in her 

nose, mouth, and eyes. Id. Petitioner was also noted to be depressed and tearful. Id. at 1. This 

correction was consistent with Petitioner’s allegations – but not with the contemporaneouslycreated record from this same visit, which suggests (except for gynecologic issues) that Petitioner’s 

health at the time was good.

Special Master Millman, to whom this case was originally assigned, noted after a status 

conference that the contrast between the 2014 letter and Dr. Lara’s prior record, coupled with the 

degree to which the letter seemed to parallel Petitioner’s contentions in this case, was extremely 

troubling. See Order, dated February 17, 2016 (ECF No. 48) at 1. She also noted that there was 

evidence that Dr. Lara had received professional discipline, putting her credibility at risk – and 

that it appeared that Dr. Steinman’s opinion relied on contentions about onset that were rooted in 

the altered description of the December 2012 visit. Id. at 2. Special Master Millman accordingly 

authorized Respondent to depose Dr. Lara in order to probe these issues.

Dr. Lara’s deposition did not occur until August 23, 2016, and the transcript was filed two 

months later. See Deposition Transcript, filed on October 31, 2016 (ECF No. 58). At the 

deposition, Dr. Lara testified that the additional symptoms outlined in her November 2014 letter 

were indeed reported by Petitioner, but that she had not included them in the record, as her exam 

was focused on gynecological issues. See ECF No. 58 at 9-10, 21-22. Thus, Dr. Lara maintained

that Petitioner had reported these symptoms to her in December 2012, and her November 2014 

letter accurately reflected their conversation at that time. Id. at 25-26, 28. Dr. Lara’s sworn 

testimony did not, however, make any reference to seeing the health notes that Petitioner testified 

at hearing she brought to the December 2012 appointment.

At hearing, Petitioner elaborated on the circumstances of her visit with Dr. Lara and what 

was discussed at that time. Petitioner explained that she requested the letter correcting the earlier 

medical record because she noticed that the contemporaneous record “did not describe the 

information . . . shared with [Dr. Lara]” during the appointment. Tr. at 42. She further stated that 

Dr. Lara acknowledged the contemporaneous notes did not accurately describe the additional 

symptoms she was experiencing at the time. Id. at 44 (“I recall how tired you were. You were 

teary, and you didn’t understand what was going on.”). Petitioner otherwise stated that she 

provided Dr. Lara with the personal health agenda noted above prior to the date Dr. Lara authored 

her 2014 letter (presumably in hopes it would assist her in clarifying her treatment notes), and that 

the revised notes were an accurate description of what Dr. Lara observed, and/or was told, during 

the December 2012 appointment. Id. at 74-76, 96-97.
33

V. Procedural History

Mrs. Chinea filed her Petition on January 30, 2015. Pet. at 1. The parties filed the Joint 

Statement of Completion on February 17, 2015. ECF No. 10. Additional medical records were 

filed thereafter. ECF Nos. 14-17, 22-24, 29-30, 34. Respondent then filed his Rule 4(c) report on 

December 1, 2015, denying that Mrs. Chinea was entitled to compensation. ECF No. 41.

Thereafter, the parties began filing expert reports. Petitioner filed an initial expert report 

from Dr. Steinman on August 21, 2015. ECF No. 31. Respondent filed an initial expert report from 

Dr. Donofrio on December 1, 2015. ECF No. 42. Following a request by the Court to supplement 

the record with additional expert support, Petitioner filed a second expert report from Dr. Steinman

on February 16, 2017. ECF No. 64. Thereafter, Respondent filed a supplemental report from Dr. 

Donofrio on April 24, 2017. ECF No. 65. Given the issues identified in the expert reports (and 

supporting fact witness declarations), the matter was set for hearing on August 6-7, 2018, in 

Woodland Hills, California, to determine entitlement. ECF No. 67. The matter was subsequently 

reassigned to me. 

The hearing took place as scheduled, and included testimony from the experts identified 

above (along with testimony from Petitioner and multiple fact witnesses). Following the hearing’s 

conclusion, the parties submitted post-hearing briefs on October 31, 2018. ECF Nos. 88-87. The

matter is ripe for adjudication.

VI. Applicable Law

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 & Human Servs., 592 F.3d 1315, 1321 (Fed. 

Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).38

In this case, Petitioner does not assert a Table claim.

 

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

authority. Hanlon v. Sec’y of Health & Human 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 & Human Servs., 59 Fed. Cl. 121, 

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

159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
34

For both Table and Non-Table claims, 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 or speculation is insufficient under a preponderance standard). 

Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human 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 & Human Servs., 165 F.3d 1344, 

1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human 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 & Human 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.” Althen, 418 F.3d at 1278.

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 & Human 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 & Human 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 v. Sec’y of 
35

Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases may be 

enough to satisfy Althen prong one” (emphasis in original)), vacated on other grounds, 844 F.3d

1363 (Fed. Cir. 2017). But this does not negate or reduce a petitioner’s ultimate burden to establish 

his overall entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Human 

Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).39

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 & Human 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 & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se

bind the special master 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 & Human 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 also be 

weighed against other, contrary evidence also present in the record – including conflicting opinions 

among such individuals. Hibbard v. Sec’y of Health & Human 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); Caves v. Sec’y of Dept. of Health & 

Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. 

for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed. 

Cir. 2012).

 

39 Although decisions like Contreras suggest that the burden of proof required to satisfy the first Althen prong is less 

stringent than the other two, there is ample contrary authority for the more straightforward proposition that when 

considering the first prong, the same preponderance standard used overall is also applied when evaluating if a reliable 

and plausible causal theory has been established. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 

1350 (Fed. Cir. 2010). 
36

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 

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

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

what is a medically acceptable timeframe must also coincide 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 & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 

353 (2012), aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human 

Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review 

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

B. Law Governing Analysis of Fact Evidence

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 & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (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).

Medical records that are created contemporaneously with the events they describe are 

presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s 

health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human 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 & 

Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is 

based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people 

honestly report their health problems to those professionals; and (iii) medical professionals record 
37

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 & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. 

Apr. 10, 2013); Cucuras v. Sec’y of Health & Human 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.”).

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

be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005 

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

records are generally 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 & Human 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, there are situations in which compelling oral testimony may be more persuasive 

than written records, such as where records are deemed to be incomplete or inaccurate. Campbell 

v. Sec’y of Health & Human 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 & Human 

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 & Human 

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. 
38

Sec’y of Health & Human 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.

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 & Human 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 & Human Servs., 617 F.3d 1328, 1339 

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

1999). “The Daubert 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).

The Daubert factors play a slightly different role in Vaccine Program cases than they do 

when applied in other federal judicial for a (such as the district courts). Daubert factors are usually 

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

that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors 

are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health 

& Human 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 of his own 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 & Human 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 
39

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 91997)); see also Isaac v. Sec’y of Health & 

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

for review den’d, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. 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 & Human 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 medical and scientific literature in this case, but not every filed item 

factors into the outcome of this decision. While I have reviewed all of 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 & Human 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 & Human 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”).

ANALYSIS

I. Overview of GBS and Relevant Program Law 

As literature filed in this case establishes, GBS is a peripheral neuropathy involving 

rapidly-progressive and ascending motor neuron paralysis. Vucic at 733; Menze at 167. Its etiology

is unknown, although two-thirds of GBS cases follow an antecedent infection (typically an upper 

respiratory tract or gastrointestinal infection) beginning a few weeks prior to symptoms onset. 

Vucic at 733 (six weeks pre-onset); Menze at 167 (two weeks pre-onset). GBS has also been 

reported following surgery, head trauma, and vaccination. Id. at 734. It is believed to have an 

autoimmune mechanism. Vucic at 733; Menze at 167, 180. A GBS diagnosis centers on a thorough 

medical assessment involving clinical presentation, nerve conduction studies, and CSF analysis. 

Vucic at 734; Menze at 168.
40

GBS’s primary clinical features are generalized muscle weakness combined with sensory 

symptoms. Vucic at 734. GBS typically begins abruptly with paresthesia in the feet, progressing

to a flaccid paralysis of the lower limbs and ascending to the trunk, upper limbs, and face (although 

some cases involve paresthesia in all four limbs simultaneously or paresthesia beginning in the 

upper limbs and descending downward). Vucic at 733-34; Menze at 167. Weakness of the facial 

muscles is common and is frequently bilateral. Vucic at 734; Menze at 167. Respiratory weakness 

is a common feature (requiring arterial ventilation in severe cases). Vucic at 734. Eighty to ninety 

percent of patients become nonambulatory due to weakness. Menze at 167. Other characteristics 

include low-grade fever, bulbar palsy, absent tendon reflexes, and increased protein levels in the 

cerebral spinal fluid without a corresponding increase in cells. Vucic at 733-34. The Miller-Fisher 

variant (consistent with Petitioner’s diagnosis) is clinically characterized as evidencing additional 

adverse symptoms, including ophthalmological abnormalities, ataxia, and areflexia. Id. at 734; 

Menze at 168-69. 

GBS patients typically reach nadir of their illness between two and four weeks following 

onset, with a plateauing of symptoms thereafter. Vucic at 734, 737; Menze at 167. The current 

diagnostic criteria include up to 4 weeks of progression to clinical nadir. Menze at 167. Although 

GBS is considered a monophasic illness, between seven and sixteen percent of patients suffer 

recurrent episodes of worsening after initial onset and improvement. Vucic at 734. Sequela of GBS 

can include severe fatigue and persistent pain in some cases. Menze at 179. The majority of patients 

reach a full recovery (with only ten to twenty percent experiencing significant deficits). Vucic at 

737. Up to one-third of GBS patients require some alteration to their daily routine due to the 

residual functional deficits. Id. Adverse prognosis factors can include: older age at disease onset 

(i.e., >50 years), severity of the disease course at nadir, rapid onset, and the presence of an 

underlying infection. Id.

The association between the flu vaccine and GBS is well-established in the Vaccine 

Program. See, e.g., Strong v. Sec’y of Health & Human Servs., No. 15-1108V, 2018 WL 1125666 

(Fed. Cl. Spec. Mstr. Jan. 12, 2018); Stitt v. Sec’y of Health & Human Servs., No. 09-653V, 2013 

WL 3356791 (Fed. Cl. Spec. Mstr. May 31, 2013); Stewart v. Sec'y of Health & Human Servs., 

No. 06-777V, 2011 WL 3241585, at *16 (Fed. Cl. Spec. Mstr. July 8, 2011); see also Barone v. 

Sec'y of Health & Human Servs., No. 11-707V, 2014 WL 6834557 (Fed. Cl. Spec. Mstr. Nov. 12, 

2014). Indeed, GBS was added in 2017 as a Table Claim for the flu vaccine (although this case 

does not involve such a claim). See 42 C.F.R. § 100.3(a). Accordingly, my resolution of 

Petitioner’s claim does not turn on a finding, under Althen prong one, that (for purposes of 

adjudicating a Program claim) the flu vaccine “can cause” GBS, for that question has been 

thoroughly examined and answered in the affirmative.
41

There are nevertheless some limits to the kinds of fact patterns that successfully establish 

that the flu vaccine “did cause” a particular petitioner’s GBS under the second Althen prong. In 

most successful non-Table cases, onset of symptoms is demonstrated to have occurred no longer 

than six to eight weeks after vaccination. See, e.g., Barone, 2014 WL 6834557, at *13 (eight weeks 

is the longest reasonable timeframe for a flu/GBS injury). I am aware of no published Vaccine 

Program decisions that have found a timeframe longer than two months to be medically acceptable. 

See, e.g., Aguayo v. Sec'y of Health & Human Servs., No. 12-563V, 2013 WL 441013, at *4 (Fed. 

Cl. Spec. Mstr. Jan. 15, 2013) (three and one-half month onset for flu/GBS injury deemed too 

attenuated to be causal); Corder v. Sec'y of Health & Human Servs., No. 08-228V, 2011 WL 

2469736, at *27-29 (Fed. Cl. Spec. Mstr. May 31, 2011) (proposed four-month onset period from 

vaccination to GBS injury is too long; two months is the longest reasonable timeframe).

Such limits are in keeping with well-recognized Program case law. It is not enough for a 

petitioner to argue that her illness post-dated receipt of a particular vaccine – for that is another 

way of simply invoking the temporal relationship between vaccine and injury, something

understood in the Program to have little evidentiary bearing when determining entitlement. See, 

e.g., LaLonde v. Sec'y of Health & Human Servs., 746 F.3d 1334, 1341 (Fed. Cir. 2014) (“[a] 

temporal correlation alone is not enough to demonstrate causation”).

II. Petitioner Has Not Established That Her Symptoms Before January 2013 Were

More Likely Than Not Related to Her Subsequently-Diagnosed GBS

Before determining whether Petitioner has carried her overall burden in this case, I must 

make a fact determination regarding the onset of Petitioner’s first GBS-related symptoms. 

Petitioner argues for an onset beginning sometime in November 2012, while Respondent favors 

onset no sooner than a week to ten days before Mrs. Chinea’s late-January 2013 hospitalization.

See Pre-Hearing Brief, filed on Oct. 31, 2018 (ECF No. 88) at 4-5; Donofrio Rep at 8; Ex. 7 at 4.

It is undisputed that Petitioner did not see a healthcare professional between October 31, 

2012 (the day she received the flu vaccine) and late January 2013 to obtain treatment for the

symptoms associated with her alleged 2012 onset of GBS. And the record is largely devoid of 

persuasive evidence that she even informed any treaters before late January that she felt out of the 

ordinary. She unquestionably saw a gynecologist, Dr. Lara, in December 2012, and arguably 

informed her of her then-present symptoms (despite the fact that she saw Dr. Lara for an entirely 

different kind of treatment), although the contemporaneous record of this visit says nothing about 

the symptoms Petitioner and her witnesses described at hearing. Although Petitioner maintains 

that this record is in error, Petitioner has not successfully established why I should give the original,
42

contemporaneous document less weight than her subsequent (and somewhat self-serving) 

revisions.40

The testimony offered by the fact witnesses at hearing, however, was more persuasive. 

These witnesses recounted their personal observations of Petitioner’s demonstrated fatigue and 

other symptoms in November and December 2012. All of Petitioner’s fact witnesses appeared to 

be credible individuals, and I have no doubt that they made an honest effort to recall what they 

saw at the time. Their contentions were also not rebutted. I can therefore conclude that Petitioner 

did experience overall fatigue/malaise, inter alia, beginning in November 2012 and running into 

January 2013, and that these symptoms affected her professional and social life. 

However – and in light of what is known regarding the typical GBS clinical presentation –

I do not find that Petitioner successfully established that any such symptoms represented the onset 

of her subsequently-diagnosed GBS. Respondent and his expert, Dr. Donofrio, persuasively 

established that GBS is understood to be an acute-onset, monophasic disease. See, e.g., Vucic at 

733-34; Menze at 167. Although some of the symptoms Petitioner experienced in the fall of 2012 

could be secondarily associated with GBS, they would not be presenting symptoms of the illness. 

Petitioner’s witnesses most credibly suggested they observed Petitioner in the weeks before 

Thanksgiving displaying malaise and fatigue – but this is not how GBS presents. The record was 

otherwise not supportive of the conclusion that Petitioner was experiencing nascent GBS in 

November or December 2012 (and no treater evidence beyond the discredited statements of Dr. 

 

40 As already noted, Dr. Lara’s contemporaneous record from the December 2012 visit makes no mention of any nongynecologic complaints. The updated “version” from November 2014, by Dr. Lara’s admission, was not solely the 

product of her own recollection, but was prompted by Petitioner (who sought revisions to the original document right 

before filing this case). See Deposition Transcript (filed as ECF No. 58) at 18-21. Moreover, at hearing, Petitioner 

revealed that she had located a previously-undisclosed set of notes that she purported to always prepare when attending 

a visit with a medical provider, and which she claimed to have brought to Dr. Lara in December 2012 – and yet no 

mention of these notes was made at all during Dr. Lara’s deposition. Dr. Lara’s own credibility was also properly 

called into question during this case, given her prior professional misconduct. See, e.g., Swick v. Sec’y of Health & 

Human Servs., No. 13-526V, 2018 WL 1514453, at *6-7 (Fed. Cl. Spec. Mstr. Feb. 26, 2018) (“failure to disclose [a] 

reprimand diminishes [expert’s] credibility”) (citing Contreras v. Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 

238 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017)). And although Dr. Lara did provide sworn 

testimony at her deposition that (to the extent it was not rebutted) should be given some consideration, her absence as 

a witness in this case is a further reason to give that deposition testimony less weight, because her statements have a 

hearsay quality, and she has not otherwise been demonstrated to have been unable to attend the hearing. See, e.g., 

Pickney v. United States, 82 Fed. Cl. 627, 636 n.8 (2008) (“[t]estimony given in a deposition may be presented to the 

court if the declarant is unavailable”) (emphasis added) (referencing Fed. R. Evid. 804); RCFC 32(a).

 For all these reasons, I do not find that the revised version of Dr. Lara’s medical record should be given more weight 

than the original 2012 record. See, e.g., Cucuras, 993 F.2d at 1528; Murphy, 23 Cl. Ct. at 733 (citing United States v. 

Gypsum Co., 333 U.S. 364, 396 (1974)). However, even if I had found the contrary, the corrected version of the 

December 2012 record that Petitioner favors would not alter my determination herein – for, as discussed below, I do 

not find that any of Petitioner’s purported symptoms from the fall of 2012 constituted onset of her subsequentlydiagnosed GBS, or were even related.
43

Lara exist that could be invoked for the contrary), or that any of these earlier symptoms had 

anything at all to do with Petitioner’s late-January 2013 symptoms.

Dr. Steinman endeavored to describe a smoldering form of GBS that could not only begin 

with secondary symptoms but thereafter progressively meander, only becoming acute over an 

eleven-week period, and long after the autoantibodies he deemed essential to the condition would 

have first been produced in reaction to the flu vaccine. But he was wholly unsuccessful and 

unpersuasive in his efforts. The form of GBS he described is not recognized in the medical 

literature filed in this case.41 Literature like Wanschitz discussed purportedly longer timeframes 

for GBS only after a presentation sufficiently acute for a diagnosis, and was thus unhelpful in 

establishing GBS’s course measured from the time of initial proposed insult (in this case, 

vaccination). Dr. Steinman otherwise, and despite his immense credentials as an immunologist, 

does not have a current, demonstrated expertise in studying or treating GBS sufficient to breathe 

life into his theory. Instead, the theory he espoused seems the product of his admitted goal: to 

“provide” a theory that would be useful to the Petitioner.

Such asides at hearing also greatly undercut Dr. Steinman’s overall credibility as a 

testifying expert. Although his familiarity with Vaccine Act claims (as a result of his frequent 

participation as an expert in Program cases) may have provided him some layman’s insight into 

the relevant law, it is wholly inappropriate for a scientific or medical expert to comment at hearing

on such legal subjects. He was not offered as an expert on Vaccine Act law – and even if he were, 

it is the sole purview of the judicial officer presiding over a legal case (here, the special master) to 

interpret and apply the law, subject to argument by counsel (and any subsequent appellate input). 

See, e.g., El–Shifa Pharm. Indus. Co. v. United States, 378 F.3d 1346, 1361 (Fed. Cir. 2004) (“it 

is emphatically the province and duty of the judicial department to say what the law is”). I would 

never permit a Program petitioner to offer a “legal expert” to comment on the proper application 

of Althen or any other controlling precedent in the Vaccine Program. Dr. Steinman’s unsolicited 

views on such matters were thus especially unwelcome and unhelpful.42

All in all, the record and witness testimony does not support the conclusion that any of 

Petitioner’s fall 2012 symptoms were GBS-related, or that she experienced any GBS-related onset 

before late January 2013. I therefore find that her onset occurred no sooner than January 20-28, 

2013 (or within eleven days prior to her hospital presentation). See Ex. 7 at 4, 7-8.

 

41 To the extent this proposed GBS variant resembles CIPD, I note that Petitioner was never diagnosed with CIDP, 

and Petitioner does not otherwise allege that her GBS diagnosis was inaccurate.

42 I have criticized Dr. Steinman in other cases for testifying in this manner. See, e.g., Rolshoven v. Sec’y of Health & 

Human Servs., No. 14-439V, 2018 WL 1124737 (Fed. Cl. Spec. Mstr. Jan. 11, 2018). If Dr. Steinman continues in the 

future to comment on Vaccine Program legal standards in cases before me, he will see a reduction in expert fees 

awarded, due to the wholly unhelpful and irrelevant nature of such testimony.
44

III. Petitioner’s GBS Onset was Too Long After Her Receipt of the Flu Vaccine to Satisfy 

the Third Althen Prong43

The most reliable medical literature offered in this case establishes that a reasonable 

timeframe for onset of GBS after vaccine administration is no more than six to eight weeks. See, 

e.g., Langmuir at 841; Schonberger at 105. This is echoed by the timeframe set for the Table 

version of the claim (see 42 C.F.R. § 100.3 (2017)), which is grounded in scientific observation of 

how the flu vaccine would result in harmful demyelination. Langmuir/Schonberger are both 

routinely relied on by opining experts in the Program, as well as other special masters. See, e.g., 

Corder, 2011 WL 2469736, at *27-29. And both experts in this case tended to agree that the abovementioned timeframes are medically acceptable in the context of a flu/GBS injury. Accordingly, 

and measuring from the October 31, 2012 vaccination, Petitioner’s GBS (if vaccine-caused)should 

have at least manifested by no later than the end of December 2012 – not almost a month thereafter.

Petitioner argues for a longer timeframe, but her contentions lack reliable support in 

science or fact. Beyond Dr. Steinman’s say so, nothing was filed in this case that would credibly 

establish the reliability of a three month post-vaccination timeframe. Ahmed involves a different, 

central nervous system condition (narcolepsy) with a wholly different pathogenic mechanism, and 

therefore the length of time it might take for an H1N1 flu vaccine to trigger that condition cannot 

be applied credibly to an entirely different injury. Wanschitz does not address the question 

presented herein – the expected timeframe from insult (in this case, vaccination) to onset – and 

therefore the individual reliability of its specific findings cannot be expanded to mean that the 

timeframe for GBS is potentially much longer than existing science suggests. Dr. Steinman’s 

testimony on the topic also acknowledged that Wanschitz researchers were primarily focused on 

measuring myelin destruction following acute onset (not the pre-acute stage). See Tr. at 282. And 

Dr. Steinman’s own experience in treating GBS (which would presumably inform him of clinical 

 

43 As already noted, I do not include an extended discussion of the first Althen prong (which Petitioner effectively 

satisfied). I also do not engage in an extended Althen prong two analysis, given my determination that the timeframe 

for onset of Petitioner’s GBS was too remote from vaccination to be deemed medically reasonable. See, e.g., Hunt v. 

Sec’y of Health & Human Servs., 123 Fed. Cl. 509, 524-25 (2015) (citing Veryzer v. Sec’y of Health & Human Servs., 

100 Fed. Cl. 344, 355-56, aff’d, 475 F. App’x 765 (Fed. Cir. 2012)). However, I note that the record does not support 

the conclusion in this case that the flu vaccine “did cause” Petitioner’s GBS. Her symptoms did not reflect an ongoing 

inflammatory process (sufficient to corroborate her contention that she was experiencing some kind of autoimmune 

process), or the manner in which GBS most commonly would progress, and the medical record does not establish that 

any contemporaneous treaters (not prompted by Petitioner’s views about a causal association) separately opined that 

the October flu vaccine likely caused her January illness. The fact that she tested positive for the anti-GQ1B antibody 

(which is unquestionably associated with the Miller-Fisher GBS variant with which she was diagnoses) also does not 

help Petitioner, even if the flu vaccine can be associated with that antibody. Dr. Steinman did not persuasively establish 

that a vaccine can create an antibody that thereupon takes months to instigate an acute illness like GBS, nor did he 

demonstrate that the antibody would cause the kinds of secondary symptoms Mrs. Chinea alleges to have experienced 

in November and December 2012 before her GBS became acute.
45

symptom presentation and common disease courses) was outmatched by Dr. Donofrio’s

demonstrated, treatment-derived understanding of the condition. Dr. Steinman’s personal 

vouching for his timeframe theory did not imbue it with a strength it otherwise lacked.

The proposed timeframe is also deficient factually. As already noted, Petitioner’s fatigue 

and other nonspecific symptoms in the fall of 2012 were inconsistent with how GBS is understood 

to manifest, and at best reflect symptoms that would follow – not precede – initial acute 

presentation. Although the witnesses who testified may have credibly established that Petitioner 

experienced these symptoms, none had any neurologic expertise, and therefore their observations 

of Petitioner’s condition do not convert these symptoms into GBS onset. Mrs. Chinea’s medical 

history from the October 31, 2012 vaccination to her January 31, 2013 ER visit does not describe 

a GBS course (and indeed, the contemporaneous records from when she presented to the hospital 

indicate that she seemed largely healthy until the week or so before – inconsistent with a vaccinecaused injury where that vaccine was administered eleven or more weeks prior).

At bottom, Petitioner has attempted to deem the actual chronology of her health history as 

a medically acceptable timeframe. That history was characterized by long periods of mild 

symptoms (never deemed significant enough by Petitioner to warrant a treatment visit) not directly 

associated with GBS, and which occurred prior to the time she experienced sufficiently acute 

symptoms to seek emergency treatment. See, e.g., Tr. at 232, 251-52, 283-84, 289-90. Ultimately, 

Petitioner relies too heavily on the (long) temporal relationship between her vaccination and her 

subsequent onset of GBS, a position clearly rejected by relevant case law. See, e.g., U.S. Steel 

Group v. United States, 96 F.3d 1352, 1358 (Fed. Cir. 1996) (“[b]ut to claim that the temporal link 

between these events proves that they are causally related is simply to repeat the ancient fallacy: 

post hoc ergo propter hoc”); Fricano v. United States, 22 Cl. Ct. 76, 80 (1991) (“[P]ost hoc ergo 

propter hoc . . . is regarded as neither good logic nor good law”); Doe/34 v. Sec'y of Health & 

Human Servs., 2009 WL 1955140, at *10 (Fed. Cl. Spec. Mstr. Mar. 4, 2009); Pafford v. Sec'y of 

Health and Human Servs., No. 01-0165V, 2004 WL 1717359, at *9 (Fed. Cl. Spec. Mstr. July 16, 

2004), aff'd, 64 Fed. Cl. 19 (2005), aff'd, 451 F.3d 1352 (Fed. Cir. 2006). Petitioner has not 

successfully demonstrated that a flu vaccine administered eleven to twelve weeks before she 

experienced true clinical indicia of GBS could be related to, or causal of, that disease.

CONCLUSION

The evidentiary record does not support Petitioner’s contention that the flu vaccine she 

received in October 2012 caused her GBS in the timeframe proffered, or that the symptoms she 

experienced in November and December 2012 were manifestations of that GBS. Petitioner has not 

established entitlement to a damages award, and therefore I must DISMISS her claim.
46

In the absence of a timely-filed motion for review (see Appendix B to the Rules of the 

Court), the Clerk shall enter judgment in accordance with this decision.44

IT IS SO ORDERED.

 /s/ Brian H. Corcoran

Brian H. Corcoran

Special Master

 

44 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their 

right to seek review.